{"article": "12.7.2019 EN Official Journal of the European Union L 188/55 REGULATION (EU) 2019/1156 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on facilitating cross-border distribution of collective investment undertakings and amending Regulations (EU) No 345/2013, (EU) No 346/2013 and (EU) No 1286/2014 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Divergent regulatory and supervisory approaches concerning the cross-border distribution of alternative investment funds (AIFs) as defined in Directive 2011/61/EU of the European Parliament and of the Council (3), including European venture capital funds (EuVECA) as defined in Regulation (EU) No 345/2013 of the European Parliament and of the Council (4), European social entrepreneurship funds (EuSEF) as defined in Regulation (EU) No 346/2013 of the European Parliament and of the Council (5), and European Long-Term Investment Funds (ELTIF) as defined in Regulation (EU) 2015/760 of the European Parliament and of the Council (6), as well as undertakings for collective investment in transferable securities (UCITS) within the meaning of Directive 2009/65/EC of the European Parliament and of the Council (7), result in fragmentation and barriers to cross-border marketing and access of AIFs and UCITS, which in turn could prevent them from being marketed in other Member States. A UCITS might be externally or internally managed, depending on its legal form. Any provisions of this Regulation relating to UCITS management companies should apply both to companies, the regular business of which is the management of UCITS and to any UCITS which has not designated a UCITS management company. (2) In order to enhance the regulatory framework applicable to collective investment undertakings and to better protect investors, marketing communications addressed to investors in AIFs and UCITS should be identifiable as such, and should describe the risks and rewards of purchasing units or shares of an AIF or UCITS in an equally prominent manner. In addition, all information included in marketing communications addressed to investors should be presented in a manner that is fair, clear and not misleading. To safeguard investor protection and secure a level playing field between AIFs and UCITS, the standards for marketing communications should apply to marketing communications of AIFs and UCITS. (3) Marketing communications addressed to investors in AIFs and UCITS should specify where, how and in which language investors can obtain summarised information on investor rights and they should clearly state that the AIFM, the EuVECA manager, the EuSEF manager or the UCITS management company (together, \u2018managers of collective investment undertakings\u2019), has the right to terminate the arrangements made for marketing. (4) In order to increase transparency and investor protection and facilitate access to information on national laws and regulations and administrative provisions applicable to marketing communications, competent authorities should publish such texts on their websites in, as a minimum, a language customary in the sphere of international finance, including their non-official summaries which would allow managers of collective investment undertakings to get a broad overview of those laws, regulations and administrative provisions. The publication should only be for information purposes and should not create legal obligations. For the same reasons, the European Supervisory Authority (European Securities and Markets Authority) established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (8) (ESMA) should create a central database containing summaries of national requirements for marketing communications and hyperlinks to the information published on the websites of competent authorities. (5) In order to promote good practices of investor protection which are enshrined in the national requirements for fair and clear marketing communications, including on-line aspects of such marketing communications, ESMA should issue guidelines on the application of those requirements for marketing communications. (6) Competent authorities should be able to require prior notification of marketing communications for the purpose of ex-ante verification of compliance of those communications with this Regulation and other applicable requirements, such as whether the marketing communications are identifiable as such, whether they describe the risks and rewards of purchasing units of a UCITS and, where a Member State allows marketing of AIFs to retail investors, the risks and rewards of purchasing units or shares of an AIF in an equally prominent manner and whether all information in the marketing communications is presented in a manner that is fair, clear and not misleading. That verification should be performed within a limited timeframe. Where competent authorities require prior notification, this should not prevent them from verifying marketing communications ex-post. (7) Competent authorities should report to ESMA the results of those verifications, requests for amendments and any sanctions imposed on managers of collective investment undertakings. With a view to increasing awareness and transparency on the rules applicable to marketing communications, on the one hand, and ensuring investor protection, on the other hand, ESMA should every second year prepare and send to the European Parliament, the Council and the Commission a report on those rules and their practical application on the basis of ex-ante and ex-post verifications of marketing communications by competent authorities. (8) To ensure equal treatment of managers of collective investment undertakings and to facilitate their decision-making regarding whether to engage in cross-border distribution of investment funds, it is important that fees and charges levied by competent authorities for supervision of cross-border activities are proportionate to the supervisory tasks carried out and publicly disclosed, and that, in order to enhance transparency, those fees and charges are published on the websites of the competent authorities. For the same reason, hyperlinks to the information published on the websites of competent authorities in relation to the fees and charges should be published on the ESMA website in order to have a central point for information. The ESMA website should also include an interactive tool enabling indicative calculations of those fees and charges levied by competent authorities. (9) To ensure better recovery of fees or charges and to increase the transparency and clarity of the fees and charges structure, where such fees or charges are levied by the competent authorities, managers of collective investment undertakings should receive an invoice, an individual payment statement or a payment instruction clearly setting out the amount of fees or charges due and the means of payment. (10) Since ESMA, in accordance with Regulation (EU) No 1095/2010, should monitor and assess market developments in the area of its competence, it is appropriate and necessary to enhance the knowledge of ESMA by enlarging ESMA's currently existing databases to include a central database listing all AIFs and UCITS that are marketed cross-border, the managers of those collective investment undertakings and the Member States in which the marketing takes place. For that purpose, and in order to enable ESMA to maintain the central database up-to-date, competent authorities should transmit to ESMA information on the notifications and notification letters and information that they have received under Directives 2009/65/EC and 2011/61/EU in relation to cross-border marketing activity as well as information about any changes which should be reflected in that database. In that respect, ESMA should establish a notification portal into which competent authorities should upload all documents regarding the cross-border distribution of UCITS and AIFs. (11) In order to ensure a level playing field between qualifying venture capital funds as defined in Regulation (EU) No 345/2013, or qualifying social entrepreneurship funds as defined in Regulation (EU) No 346/2013, on the one hand, and other AIFs, on the other hand, it is necessary to include in those Regulations rules on pre-marketing that are identical to the rules laid down in Directive 2011/61/EU on pre-marketing. Such rules should enable managers registered in accordance with those Regulations to target investors by testing their appetite for upcoming investment opportunities or strategies through qualifying venture capital funds and qualifying social entrepreneurship funds. (12) In accordance with Regulation (EU) No 1286/2014 of the European Parliament and of the Council (9), certain companies and persons referred to in Article 32 of that Regulation are exempt from the obligations under that Regulation until 31 December 2019. That Regulation also provides that the Commission is to review it by 31 December 2018, in order to assess, inter alia, whether that transitional exemption should be prolonged, or whether, following the identification of any necessary adjustments, the provisions on key investor information in Directive 2009/65/EC should be replaced by or considered equivalent to the key information document as laid down in that Regulation. (13) In order to allow the Commission to conduct the review in accordance with Regulation (EU) No 1286/2014 as originally provided for, the deadline for that review should be extended by 12 months. The competent committee of the European Parliament should support the Commission's review process by organising a hearing on the topic with relevant stakeholders representing industry and consumer interests. (14) In order to avoid investors receiving two different pre-disclosure documents, namely a key investor information document (KIID) as required by Directive 2009/65/EC and a key information document (KID) as required by Regulation (EU) No 1286/2014, for the same collective investment undertaking while the legislative acts resulting from the Commission's review in accordance with that Regulation are being adopted and implemented, the transitional exemption from the obligations under that Regulation should be prolonged by 24 months. Without prejudice to that prolongation, all institutions and supervisory authorities involved should endeavour to act as fast as possible to facilitate the termination of that transitional exemption. (15) The Commission should be empowered to adopt implementing technical standards, developed by ESMA, with regard to the standard forms, templates and procedures for publication and notification by competent authorities of the national laws, regulations and administrative provisions and their summaries on marketing requirements applicable in their territories, the levels of fees or charges levied by them for cross-border activities, and, where applicable, relevant calculation methodologies. Furthermore, to improve the transmission to ESMA, implementing technical standards should also be adopted with respect to notifications, notification letters and information on cross-border marketing activities that are required by Directives 2009/65/EC and 2011/61/EU and the technical arrangements necessary for the functioning of the notification portal to be established by ESMA. The Commission should adopt those implementing technical standards by means of implementing acts pursuant to Article 291 of the Treaty on the Functioning of the European Union (TFEU) and in accordance with Article 15 of Regulation (EU) No 1095/2010. (16) It is necessary to specify the information to be communicated every quarter to ESMA, in order to keep the databases of all collective investment undertakings and their managers up to date. (17) Any processing of personal data carried out within the framework of this Regulation, such as the exchange or transmission of personal data by the competent authorities, should be undertaken in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (10), and any exchange or transmission of information by ESMA should be undertaken in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (11). (18) In order to enable the competent authorities to exercise the functions attributed to them in this Regulation, Member States should ensure that those authorities have all the necessary supervisory and investigative powers. (19) By 2 August 2024, the Commission should conduct an evaluation of the application of this Regulation. The evaluation should take account of market developments and assess whether the measures introduced have improved the cross-border distribution of collective investment undertakings. (20) By 2 August 2021 the Commission should publish a report on reverse solicitation and demand on the own initiative of an investor, specifying the extent of that form of subscription to funds, its geographical distribution including in third countries, and its impact on the passporting regime. (21) In order to ensure legal certainty, it is necessary to synchronise the application dates of national laws, regulations and administrative provisions implementing Directive (EU) 2019/1160 of the European Parliament and of the Council (12) and of this Regulation with regard to provisions on marketing communications and pre-marketing. (22) Since the objective of this Regulation, namely to enhance market efficiency while establishing the capital markets union, cannot be sufficiently achieved by the Member States but can rather, by reason of its effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes uniform rules on the publication of national provisions concerning marketing requirements for collective investment undertakings and on marketing communications addressed to investors, as well as common principles concerning fees and charges levied on managers of collective investment undertakings in relation to their cross-border activities. It also provides for the establishment of a central database on the cross-border marketing of collective investment undertakings. Article 2 Scope This Regulation shall apply to: (a) alternative investment fund managers; (b) UCITS management companies, including any UCITS which has not designated a UCITS management company; (c) EuVECA managers; and (d) EuSEF managers. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (a) \u2018alternative investment funds\u2019 or \u2018AIFs\u2019 means AIFs as defined in point (a) of Article 4(1) of Directive 2011/61/EU, and include EuVECA, EuSEF and ELTIF; (b) \u2018alternative investment fund managers\u2019 or \u2018AIFMs\u2019 means AIFMs as defined in point (b) of Article 4(1) of Directive 2011/61/EU and authorised in accordance with Article 6 of that Directive; (c) \u2018EuVECA manager\u2019 means a manager of a qualifying venture capital fund as defined in point (c) of the first paragraph of Article 3 of Regulation (EU) No 345/2013 and registered in accordance with Article 14 of that Regulation; (d) \u2018EuSEF manager\u2019 means a manager of a qualifying social entrepreneurship fund as defined in point (c) of Article 3(1) of Regulation (EU) No 346/2013 and registered in accordance with Article 15 of that Regulation; (e) \u2018competent authorities\u2019 means competent authorities as defined in point (h) of Article 2(1) of Directive 2009/65/EC or in point (f) of Article 4(1) of Directive 2011/61/EU or competent authorities of the EU AIF as defined in point (h) of Article 4(1) of Directive 2011/61/EU; (f) \u2018home Member State\u2019 means the Member State in which the AIFM, the EuVECA manager, the EuSEF manager or the UCITS management company has its registered office; (g) \u2018UCITS\u2019 means a UCITS authorised in accordance with Article 5 of Directive 2009/65/EC; (h) \u2018UCITS management company\u2019 means a management company as defined in point (b) of Article 2(1) of Directive 2009/65/EC. Article 4 Requirements for marketing communications 1. AIFMs, EuVECA managers, EuSEF managers and UCITS management companies shall ensure that all marketing communications addressed to investors are identifiable as such and describe the risks and rewards of purchasing units or shares of an AIF or units of a UCITS in an equally prominent manner, and that all information included in marketing communications is fair, clear and not misleading. 2. UCITS management companies shall ensure that marketing communications that contain specific information about a UCITS do not contradict or diminish the significance of the information contained in the prospectus referred to in Article 68 of Directive 2009/65/EC or the key investor information referred to in Article 78 of that Directive. UCITS management companies shall ensure that all marketing communications indicate that a prospectus exists and that the key investor information is available. Such marketing communications shall specify where, how and in which language investors or potential investors can obtain the prospectus and the key investor information and shall provide hyperlinks to or website addresses for those documents. 3. Marketing communications referred to in paragraph 2 shall specify where, how and in which language investors or potential investors can obtain a summary of investor rights and shall provide a hyperlink to such a summary, which shall include, as appropriate, information on access to collective redress mechanisms at Union and national level in the event of litigation. Such marketing communications shall also contain clear information that the manager or management company referred to in paragraph 1 of this Article may decide to terminate the arrangements made for the marketing of its collective investment undertakings in accordance with Article 93a of Directive 2009/65/EC and Article 32a of Directive 2011/61/EU. 4. AIFMs, EuVECA managers and EuSEF managers shall ensure that marketing communications comprising an invitation to purchase units or shares of an AIF that contain specific information about an AIF do not contradict the information which is to be disclosed to the investors in accordance with Article 23 of Directive 2011/61/EU, with Article 13 of Regulation (EU) No 345/2013 or with Article 14 of Regulation (EU) No 346/2013, or diminish its significance. 5. Paragraph 2 of this Article shall apply mutatis mutandis to AIFs which publish a prospectus in accordance with Regulation (EU) 2017/1129 of the European Parliament and of the Council (13), or in accordance with national law, or apply rules on the format and content of the key investor information referred to in Article 78 of Directive 2009/65/EC. 6. By 2 August 2021, ESMA shall issue guidelines, and thereafter update those guidelines periodically, on the application of the requirements for marketing communications referred to in paragraph 1, taking into account on-line aspects of such marketing communications. Article 5 Publication of national provisions concerning marketing requirements 1. Competent authorities shall publish and maintain on their websites up-to-date and complete information on the applicable national laws, regulations and administrative provisions governing marketing requirements for AIFs and UCITS, and the summaries thereof, in, as a minimum, a language customary in the sphere of international finance. 2. Competent authorities shall notify to ESMA the hyperlinks to the websites of competent authorities where the information referred to in paragraph 1 is published. Competent authorities shall notify ESMA of any change in the information provided under the first subparagraph of this paragraph without undue delay. 3. ESMA shall develop draft implementing technical standards to determine standard forms, templates and procedures for the publications and notifications under this Article. ESMA shall submit those draft implementing standards to the Commission by 2 February 2021. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Article 6 ESMA central database on national provisions concerning marketing requirements By 2 February 2022, ESMA shall publish and maintain on its website a central database containing the summaries referred to in Article 5(1), and the hyperlinks to the websites of competent authorities referred to in Article 5(2). Article 7 Ex-ante verification of marketing communications 1. For the sole purpose of verifying compliance with this Regulation and with national provisions concerning marketing requirements, competent authorities may require prior notification of marketing communications which UCITS management companies intend to use directly or indirectly in their dealings with investors. The requirement for prior notification referred to in the first subparagraph shall not constitute a prior condition for the marketing of units of UCITS and shall not be part of the notification procedure referred to in Article 93 of Directive 2009/65/EC. Where competent authorities require prior notification as referred to in the first subparagraph, they shall, within 10 working days of receipt of marketing communications, inform the UCITS management company of any request to amend its marketing communications. The prior notification referred to in the first subparagraph may be required on a systematic basis or in accordance with any other verification practices and shall be without prejudice to any supervisory powers to verify marketing communications ex-post. 2. Competent authorities that require prior notification of marketing communications shall establish, apply, and publish on their websites, procedures for such prior notification. The internal rules and procedures shall ensure transparent and non-discriminatory treatment of all UCITS, regardless of the Member States in which the UCITS are authorised. 3. Where AIFMs, EuVECA managers or EuSEF managers market units or shares of their AIFs to retail investors, paragraphs 1 and 2 shall apply mutatis mutandis to those AIFMs, EuVECA managers or EuSEF managers. Article 8 ESMA report on marketing communications 1. By 31 March 2021 and every second year thereafter, competent authorities shall report the following information to ESMA: (a) the number of requests for amendments of marketing communications made on the basis of ex-ante verification, where applicable; (b) the number of requests for amendments and decisions taken on the basis of ex-post verifications, clearly distinguishing the most frequent breaches, including a description and the nature of those breaches; (c) a description of the most frequent breaches of the requirements referred to in Article 4; and (d) one example of each of the breaches referred to in points (b) and (c). 2. By 30 June 2021 and every second year thereafter, ESMA shall submit a report to the European Parliament, the Council and the Commission which presents an overview of marketing requirements referred to in Article 5(1) in all Member States and contains an analysis of the effects of national laws, regulations and administrative provisions governing marketing communications based also on the information received in accordance with paragraph 1 of this Article. Article 9 Common principles concerning fees or charges 1. Where fees or charges are levied by competent authorities for carrying out their duties in relation to the cross-border activities of AIFMs, EuVECA managers, EuSEF managers and UCITS management companies, such fees or charges shall be consistent with the overall cost relating to the performance of the functions of the competent authority. 2. For the fees or charges referred to in paragraph 1 of this Article, competent authorities shall send an invoice, an individual payment statement or a payment instruction, clearly setting out the means of payment and the date when payment is due, to the address referred to in the third subparagraph of Article 93(1) of Directive 2009/65/EC or point (i) of Annex IV of Directive 2011/61/EU. Article 10 Publication of national provisions concerning fees and charges 1. By 2 February 2020, competent authorities shall publish and maintain up-to-date information on their websites listing the fees or charges referred to in Article 9(1), or, where applicable, the calculation methodologies for those fees or charges, in, as a minimum, a language customary in the sphere of international finance. 2. Competent authorities shall notify to ESMA the hyperlinks to the websites of competent authorities where the information referred to in paragraph 1 is published. 3. ESMA shall develop draft implementing technical standards to determine the standard forms, templates and procedures for the publications and notifications under this Article. ESMA shall submit those draft implementing standards to the Commission by 2 February 2021. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Article 11 ESMA publication on fees and charges 1. By 2 February 2022, ESMA shall publish on its website hyperlinks to the websites of competent authorities as referred to in Article 10(2). Those hyperlinks shall be kept up to date. 2. By 2 February 2022, ESMA shall develop and make available on its website an interactive tool publicly accessible in, as a minimum, a language customary in the sphere of international finance that provides an indicative calculation of the fees or charges referred to in Article 9(1). That tool shall be kept up to date. Article 12 ESMA central database on cross-border marketing of AIFs and UCITS 1. By 2 February 2022, ESMA shall publish on its website a central database on cross-border marketing of AIFs and UCITS, publicly accessible in a language customary in the sphere of international finance, listing: (a) all AIFs that are marketed in a Member State other than the home Member State, their AIFM, EuSEF manager or EuVECA manager, and the Member States in which they are marketed; and (b) all UCITS that are marketed in a Member State other than the UCITS home Member State as defined in point (e) of Article 2(1) of Directive 2009/65/EC, their UCITS management company and the Member States in which they are marketed. That central database shall be kept up to date. 2. The obligations in this Article and in Article 13 related to the database referred to in paragraph 1 of this Article shall be without prejudice to the obligations related to the list referred to in the second subparagraph of Article 6(1) of Directive 2009/65/EC, to the central public register referred to in the second subparagraph of Article 7(5) of Directive 2011/61/EU, to the central database referred to in Article 17 of Regulation (EU) No 345/2013 and to the central database referred to in Article 18 of Regulation (EU) No 346/2013. Article 13 Standardisation of notifications to ESMA 1. On a quarterly basis, competent authorities of home Member States shall communicate to ESMA the information which is necessary for the creation and maintenance of the central database referred to in Article 12 of this Regulation regarding any notification, notification letter or information referred to in Article 93(1) and Article 93a(2) of Directive 2009/65/EC and in Article 31(2), Article 32(2) and Article 32a(2) of Directive 2011/61/EU, and any changes to that information, if such changes would result in a change to the information in that central database. 2. ESMA shall establish a notification portal into which each competent authority shall upload all documents referred to in paragraph 1. 3. ESMA shall develop draft implementing technical standards to specify the information to be communicated, as well as the forms, templates and procedures for communication of the information by the competent authorities for the purposes of paragraph 1, and the technical arrangements necessary for the functioning of the notification portal referred to in paragraph 2. ESMA shall submit those draft implementing technical standards to the Commission by 2 February 2021. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph of this paragraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Article 14 Powers of competent authorities 1. Competent authorities shall have all supervisory and investigatory powers that are necessary for the exercise of their functions pursuant to this Regulation. 2. The powers conferred on competent authorities pursuant to Directives 2009/65/EC and 2011/61/EU, Regulations (EU) No 345/2013, (EU) No 346/2013 and (EU) 2015/760, including those related to penalties or other measures, shall also be exercised with respect to the managers referred to in Article 4 of this Regulation. Article 15 Amendments to Regulation (EU) No 345/2013 Regulation (EU) No 345/2013 is amended as follows: (1) in Article 3, the following point is added: \u2018(o) \u201cpre-marketing\u201d means provision of information or communication, direct or indirect, on investment strategies or investment ideas by a manager of a qualifying venture capital fund, or on its behalf, to potential investors domiciled or with a registered office in the Union in order to test their interest in a qualifying venture capital fund which is not yet established, or in a qualifying venture capital fund which is established, but not yet notified for marketing in accordance with Article 15, in that Member State where the potential investors are domiciled or have their registered office, and which in each case does not amount to an offer or placement to the potential investor to invest in the units or shares of that qualifying venture capital fund.\u2019; (2) the following Article is inserted: \u2018Article 4a 1. A manager of a qualifying venture capital fund may engage in pre-marketing in the Union, except where the information presented to potential investors: (a) is sufficient to allow investors to commit to acquiring units or shares of a particular qualifying venture capital fund; (b) amounts to subscription forms or similar documents whether in a draft or a final form; or (c) amounts to constitutional documents, a prospectus or offering documents of a not-yet-established qualifying venture capital fund in a final form. Where a draft prospectus or offering documents are provided, they shall not contain information sufficient to allow investors to take an investment decision and shall clearly state that: (a) they do not constitute an offer or an invitation to subscribe to units or shares of a qualifying venture capital fund; and (b) the information presented therein should not be relied upon because it is incomplete and may be subject to change. 2. Competent authorities shall not require a manager of a qualifying venture capital fund to notify the competent authorities of the content or of the addressees of pre-marketing, or to fulfil any conditions or requirements other than those set out in this Article, before it engages in pre-marketing. 3. Managers of qualifying venture capital funds shall ensure that investors do not acquire units or shares in a qualifying venture capital fund through pre-marketing and that investors contacted as part of pre-marketing may only acquire units or shares in that qualifying venture capital fund through marketing permitted under Article 15. Any subscription by professional investors, within 18 months of the manager of a qualifying venture capital fund having begun pre-marketing, to units or shares of a qualifying venture capital fund referred to in the information provided in the context of pre-marketing, or of a qualifying venture capital fund established as a result of the pre-marketing, shall be considered to be the result of marketing and shall be subject to the applicable notification procedures referred to in Article 15. 4. Within two weeks of having begun pre-marketing, a manager of a qualifying venture capital fund shall send an informal letter, in paper form or by electronic means, to the competent authorities of its home Member State. That letter shall specify the Member States in which and the periods during which the pre-marketing is taking or has taken place, a brief description of the pre-marketing including information on the investment strategies presented and, where relevant, a list of the qualifying venture capital funds which are or were the subject of pre-marketing. The competent authorities of the home Member State of the manager of a qualifying venture capital fund shall promptly inform the competent authorities of the Member States in which the manager of a qualifying venture capital fund is or was engaged in pre-marketing. The competent authorities of the Member State in which pre-marketing is taking or has taken place may request the competent authorities of the home Member State of the manager of a qualifying venture capital fund to provide further information on the pre-marketing that is taking or has taken place on its territory. 5. A third party shall only engage in pre-marketing on behalf of an authorised manager of qualifying venture capital fund where it is authorised as an investment firm in accordance with Directive 2014/65/EU of the European Parliament and of the Council (*1), as a credit institution in accordance with Directive 2013/36/EU of the European Parliament and of the Council (*2), as a UCITS management company in accordance with Directive 2009/65/EC, as an alternative investment fund manager in accordance with Directive 2011/61/EU, or acts as a tied agent in accordance with Directive 2014/65/EU. Such a third party shall be subject to the conditions set out in this Article. 6. A manager of a qualifying venture capital fund shall ensure that pre-marketing is adequately documented. (*1) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349).\" (*2) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).\u2019.\" Article 16 Amendments to Regulation (EU) No 346/2013 Regulation (EU) No 346/2013 is amended as follows: (1) in Article 3, the following point is added: \u2018(o) \u201cpre-marketing\u201d means provision of information or communication, direct or indirect, on investment strategies or investment ideas by a manager of a qualifying social entrepreneurship fund, or on its behalf, to potential investors domiciled or with a registered office in the Union in order to test their interest in a qualifying social entrepreneurship fund which is not yet established, or in a qualifying social entrepreneurship fund which is established, but not yet notified for marketing in accordance with Article 16, in that Member State where the potential investors are domiciled or have their registered office, and which in each case does not amount to an offer or placement to the potential investor to invest in the units or shares of that qualifying social entrepreneurship fund.\u2019; (2) the following Article is inserted: \u2018Article 4a 1. A manager of a qualifying social entrepreneurship fund may engage in pre-marketing in the Union, except where the information presented to potential investors: (a) is sufficient to allow investors to commit to acquiring units or shares of a particular qualifying social entrepreneurship fund; (b) amounts to subscription forms or similar documents whether in a draft or a final form; or (c) amounts to constitutional documents, a prospectus or offering documents of a not-yet-established qualifying social entrepreneurship fund in a final form. Where a draft prospectus or offering documents are provided, they shall not contain information sufficient to allow investors to take an investment decision and shall clearly state that: (a) they do not constitute an offer or an invitation to subscribe to units or shares of a qualifying social entrepreneurship fund; and (b) the information presented therein should not be relied upon because it is incomplete and may be subject to change. 2. Competent authorities shall not require a manager of a qualifying social entrepreneurship fund to notify the competent authorities of the content or of the addressees of pre-marketing, or to fulfil any conditions or requirements other than those set out in this Article, before it engages in pre-marketing. 3. Managers of qualifying social entrepreneurship funds shall ensure that investors do not acquire units or shares in a qualifying social entrepreneurship fund through pre-marketing and that investors contacted as part of pre-marketing may only acquire units or shares in that qualifying social entrepreneurship fund through marketing permitted under Article 16. Any subscription by professional investors, within 18 months of the manager of a qualifying social entrepreneurship fund having begun pre-marketing, to units or shares of a qualifying social entrepreneurship fund referred to in the information provided in the context of pre-marketing, or of a qualifying social entrepreneurship fund established as a result of the pre-marketing, shall be considered to be the result of marketing and shall be subject to the applicable notification procedures referred to in Article 16. 4. Within two weeks of having begun pre-marketing, a manager of a qualifying social entrepreneurship fund shall send an informal letter, in paper form or by electronic means, to the competent authorities of its home Member State. That letter shall specify the Member States in which and the periods during which the pre-marketing is taking or has taken place, a brief description of the pre-marketing including information on the investment strategies presented and, where relevant, a list of the qualifying social entrepreneurship funds which are or were the subject of pre-marketing. The competent authorities of the home Member State of the manager of a qualifying social entrepreneurship fund shall promptly inform the competent authorities of the Member States in which the manager of a qualifying social entrepreneurship fund is or was engaged in pre-marketing. The competent authorities of the Member State in which pre-marketing is taking or has taken place may request the competent authorities of the home Member State of the manager of a qualifying social entrepreneurship fund to provide further information on the pre-marketing that is taking or has taken place on its territory. 5. A third party shall only engage in pre-marketing on behalf of an authorised manager of a qualifying social entrepreneurship fund where it is authorised as an investment firm in accordance with Directive 2014/65/EU of the European Parliament and of the Council (*3), as a credit institution in accordance with Directive 2013/36/EU of the European Parliament and of the Council (*4), as a UCITS management company in accordance with Directive 2009/65/EC, as an alternative investment fund manager in accordance with Directive 2011/61/EU, or acts as a tied agent in accordance with Directive 2014/65/EU. Such a third party shall be subject to the conditions set out in this Article. 6. A manager of a qualifying social entrepreneurship fund shall ensure that pre-marketing is adequately documented. (*3) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349).\" (*4) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).\u2019.\" Article 17 Amendments to Regulation (EU) No 1286/2014 Regulation (EU) No 1286/2014 is amended as follows: (1) in Article 32(1), \u201831 December 2019\u2019 is replaced by \u201831 December 2021\u2019; (2) Article 33 is amended as follows: (a) in the first subparagraph of paragraph 1, \u201831 December 2018\u2019 is replaced by \u201831 December 2019\u2019; (b) in the first subparagraph of paragraph 2, \u201831 December 2018\u2019 is replaced by \u201831 December 2019\u2019; (c) in the first subparagraph of paragraph 4, \u201831 December 2018\u2019 is replaced by \u201831 December 2019\u2019. Article 18 Evaluation By 2 August 2024 the Commission shall, on the basis of a public consultation and in light of discussions with ESMA and competent authorities, conduct an evaluation of the application of this Regulation. By 2 August 2021 the Commission shall, on the basis of a consultation of competent authorities, ESMA and other relevant stakeholders, submit a report to the European Parliament and to the Council on reverse solicitation and demand on the own initiative of an investor, specifying the extent of that form of subscription to funds, its geographical distribution, including in third countries, and its impact on the passporting regime. That report shall also examine whether the notification portal established in accordance with Article 13(2) should be developed so that all transfers of documents between competent authorities take place through it. Article 19 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 August 2019. However, Article 4(1) to (5), Article 5(1) and (2), Article 15 and Article 16 shall apply from 2 August 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 367, 10.10.2018, p. 50. (2) Position of the European Parliament of 16 April 2019 (not yet published in the Official Journal) and decision of the Council of 14 June 2019. (3) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1). (4) Regulation (EU) No 345/2013 of the European Parliament and of the Council of 17 April 2013 on European venture capital funds (OJ L 115, 25.4.2013, p. 1). (5) Regulation (EU) No 346/2013 of the European Parliament and of the Council of 17 April 2013 on European social entrepreneurship funds (OJ L 115, 25.4.2013, p. 18). (6) Regulation (EU) 2015/760 of the European Parliament and of the Council of 29 April 2015 on European long-term investment funds (OJ L 123, 19.5.2015, p. 98). (7) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32). (8) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (9) Regulation (EU) No 1286/2014 of the European Parliament and of the Council of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (OJ L 352, 9.12.2014, p. 1). (10) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (11) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (12) Directive (EU) 2019/1160 of the European Parliament and of the Council of 20 June 2019 amending Directives 2009/65/EC and 2011/61/EU with regard to cross-border distribution of collective investment undertakings (see page 106 of this official journal). (13) Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12).", "summary": "Cross-border distribution of collective investment undertakings Cross-border distribution of collective investment undertakings SUMMARY OF: Regulation (EU) 2019/1156 on facilitating cross-border distribution of collective investment undertakings and amending Regulations (EU) No 345/2013, (EU) No 346/2013 and (EU) No 1286/2014 WHAT IS THE AIM OF THE REGULATION? It sets out uniform rules for national regulation concerning marketing requirements for collective investment undertakings (or \u2018investment funds\u2019) and on marketing communications addressed to investors, to improve market efficiency as part of establishing the EU\u2019s capital markets union. It also sets out a common approach to fees and charges levied on investment fund managers for their cross-border activities and proposes a central database on the cross-border marketing of collective investment undertakings. KEY POINTS The regulation applies to: Alternative investment fund (AIF)* managers*; Undertaking for collective investment in transferable securities (UCITS)* management companies, including any UCITS which has not designated a UCITS management company; European venture capital fund (EuVECA)* managers; and European social entrepreneurship fund (EuSEF)* managers. Marketing communications AIFMs, EuVECA, EuSEF and UCITS managers, as well as UCITS management companies, must ensure that all marketing communications addressed to investors are identifiable as such and describe the risks and rewards of purchasing units or shares of an AIF or units of a UCITS in an equally prominent manner. Marketing communications should: be fair, clear and not misleading;indicate that a prospectus exists and that key investor information is available, and specify where, how and in what language investors can obtain the prospectus and key information;specify where, how and in what language investors can obtain a summary of investor rights, which will include, where appropriate, information on access to collective redress mechanisms at EU and national level in the event of litigation;contain clear information indicating that the manager or the management company may decide to stop marketing its investment fund. Competent authorities must keep their websites up to date with complete information on applicable national laws, regulations and administrative rules, including summaries, governing marketing requirements for AIFs and UCITS, in a language customary for international finance. To verify compliance with this regulation and national rules on marketing requirements, competent authorities may require advance notice of marketing communications intended by UCITS management companies to be used directly or indirectly in their dealings with investors. Fees and charges Common principles regarding fees and charges levied by competent authorities on managers of collective investment undertakings for their cross-border activities must be consistent with the overall costs of the competent authority. By 2 February 2022, The European Securities and Markets Authority (ESMA) will make publicly available on its website an interactive tool that provides an indicative calculation of the fees or charges. Central database The regulation also introduces a central database regarding the international marketing of AIFs and UCITS within the EU. ESMA must publish this database on its website by 2 February 2022, in a language customary for international finance. Pre-marketing* The regulation introduces rules on pre-marketing EuVECAs and EuSEFs from 2 August 2021, in line with those laid down for alternative investment funds in Directive (EU) 2019/1160. The rules are aimed at allowing managers to target investors by testing their appetite for upcoming investment opportunities or strategies through qualifying venture capital funds and qualifying social entrepreneurship funds. Reporting Competent authorities must report to ESMA on marketing communications by 31 March 2021 and every 2 years, outlining the number of requests for amendments of marketing communications, clearly distinguishing the most frequent breaches, and giving examples. Evaluation By 2 August 2024, the European Commission through public consultation and discussion with ESMA and competent authorities, will conduct an evaluation of the application of the regulation. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 August 2019. Article 4(1) to (5) on marketing information, Article 5(1) and (2) on competent authority websites, and Articles 15 and 16 on amendments to previous legislation concerning pre-marketing of EuVECAs and EuSEFs apply from 2 August 2021. BACKGROUND See also: Investment funds (European Commission) UCITS \u2014 Undertakings for collective investment in transferable securities (European Commission) The European Securities and Markets Authority (ESMA). KEY TERMS Alternative investment fund (AIF): a collective investment undertaking (investment fund) which raises capital from a number of investors, with a view to investing it in accordance with a defined investment policy for the benefit of those investors, and not requiring authorisation under Article 5 of the UCITS Directive 2009/65/EC. They include EuVECA, EuSEF and ELTIF*. Alternative investment fund manager (AIFM): legal person whose regular business is managing one or more AIFs. Undertaking for collective investment in transferable securities (UCITS): an undertaking for collective investment (or \u2018investment fund\u2019) which invests in securities, i.e. in stocks, bonds, stocks and bonds, short-term treasury instruments and cash. European venture capital fund (EuVECA): a label introduced in Regulation (EU) No 345/2013 which allows managers to set up and market their funds across the EU using a single set of rules. European social entrepreneurship fund (EuSEF): a label introduced in Regulation (EU) No 346/2013 which is designed to identify funds focusing on European social businesses, making it easier for them to attract investment. Pre-marketing: providing information or communication on investment strategies or investment ideas by a manager of a qualifying venture capital fund to potential investors in the EU in order to test their interest in a qualifying venture capital fund which is not yet established. European long-term investment fund (ELTIF): introduced in Regulation (EU) 2015/760 aimed at investment fund managers who want to provide long-term investment to institutional and private investors across Europe. They target specific types of projects which require long-term funding to develop successfully but struggle to get financing. MAIN DOCUMENT Regulation (EU) 2019/1156 of the European Parliament and of the Council of 20 June 2019 on facilitating cross-border distribution of collective investment undertakings and amending Regulations (EU) No 345/2013, (EU) No 346/2013 and (EU) No 1286/2014 (OJ L 188, 12.7.2019, pp. 55-66) RELATED DOCUMENTS Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 Action plan on Building a Capital Markets Union (COM(2015) 468 final, 30.9.2015) Regulation (EU) 2015/760 of the European Parliament and of the Council of 29 April 2015 on European long-term investment funds (OJ L 123, 19.5.2015, pp. 98-121) Regulation (EU) No 1286/2014 of the European Parliament and of the Council of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (OJ L 352, 9.12.2014, pp. 1-23) Successive amendments to Regulation (EU) No 1286/2014 have been incorporated into the original text. This consolidated version is of documentary value only. Communication from the Commission to the European Parliament, the Council, the European Central Bank, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank: An investment plan for Europe (COM(2014) 903 final, 26.11.2014) Regulation (EU) No 346/2013 of the European Parliament and of the Council of 17 April 2013 on European social entrepreneurship funds (OJ L 115, 25.4.2013, pp. 18-38) See consolidated version. Regulation (EU) No 345/2013 of the European Parliament and of the Council of 17 April 2013 on European venture capital funds (OJ L 115, 25.4.2013, pp. 1-17) See consolidated version. Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, pp. 1-73) See consolidated version. Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, pp. 84-119) See consolidated version. Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, pp. 32-96) See consolidated version. last update 06.12.2019"}
{"article": "25.6.2019 EN Official Journal of the European Union L 169/1 REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33 and 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that products are compliant with Union harmonisation legislation and therefore fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, protection of consumers, protection of the environment, public security and protection of any other public interests protected by that legislation. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union market for goods can thrive. Rules are therefore necessary to ensure this enforcement, regardless of whether products are placed on the market via offline or online means and regardless of whether they are manufactured in the Union or not. (2) Union harmonisation legislation covers a large share of manufactured products. Non-compliant and unsafe products put citizens at risk, and might distort competition with economic operators selling compliant products within the Union. (3) Strengthening the single market for goods through further enhancing efforts to keep non-compliant products from being placed on the Union market was identified as a priority in the Communication from the Commission of 28 October 2015 entitled \u2018Upgrading the Single Market: more opportunities for people and business\u2019. This should be achieved by strengthening market surveillance, providing economic operators with clear, transparent and comprehensive rules, intensifying compliance controls and promoting closer cross-border cooperation among enforcement authorities, including through cooperation with customs authorities. (4) The framework for market surveillance established by this Regulation should complement and strengthen existing provisions in Union harmonisation legislation relating to the ensuring of compliance of products and the framework for cooperation with organisations representing economic operators or end users, the market surveillance of products and controls on those products entering the Union market. However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation. The corresponding provisions of this Regulation should therefore not apply in the areas covered by such specific provisions, for instance those set out in Regulations (EC) No 1223/2009 (3), (EU) 2017/745 (4) and (EU) 2017/746 (5), including as regards the use of the European database on medical devices (EUDAMED), and (EU) 2018/858 (6) of the European Parliament and of the Council. (5) Directive 2001/95/EC of the European Parliament and of the Council (7) lays down the general safety requirements for all consumer products and provides for specific obligations and powers of the Member States in relation to dangerous products as well as for the exchange of information to that effect through the Rapid Information Exchange System (RAPEX). Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive. In order to achieve a higher level of safety for consumer products, the mechanisms for exchanges of information and rapid intervention situations provided for in Directive 2001/95/EC should be made more effective. (6) The provisions on market surveillance of this Regulation should cover products that are subject to the Union harmonisation legislation listed in Annex I concerning manufactured products other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. This will ensure a uniform framework for market surveillance of those products at Union level and will help to increase the confidence of consumers and other end users in products placed on the Union market. If new Union harmonisation legislation is adopted in the future, it will be for that legislation to specify whether this Regulation is also to apply to that legislation. (7) Articles 15 to 29 of Regulation (EC) No 765/2008 of the European Parliament and of the Council (8) laying down the Community market surveillance framework and controls of products entering the Community market should be deleted and the respective provisions should be replaced by this Regulation. That framework includes the provisions on controls of products entering the Community market, in Articles 27, 28 and 29 of Regulation (EC) No 765/2008, which apply not only to products covered by the market surveillance framework, but to all products in so far as other Union law does not contain specific provisions relating to the organisation of controls on products entering the Union market. It is therefore necessary that the scope of the provisions of this Regulation with regard to products entering the Union market extend to all products. (8) In order to rationalise and simplify the overall legislative framework, while simultaneously pursuing the objectives of Better Regulation, the rules applicable to controls on products entering the Union market should be revised and integrated into a single legislative framework for controls on products at the Union's external borders. (9) Responsibility for enforcing Union harmonisation legislation should lie with the Member States, and their market surveillance authorities should be required to ensure that the legislation is fully complied with. The Member States should, therefore, establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities. In this regard, the methodology and criteria for assessing risks should be further harmonised in all Member States in order to ensure a level playing field for all economic operators. (10) In order to assist market surveillance authorities to strengthen consistency in their activities related to the application of this Regulation, an effective peer review system should be established for those market surveillance authorities wishing to participate. (11) Certain definitions currently set out in Regulation (EC) No 765/2008 should be aligned with definitions set out in other Union legal acts and, where appropriate, reflect the architecture of modern supply chains. The definition of \u2018manufacturer\u2019 in this Regulation should not relieve manufacturers of any obligations they might have under Union harmonisation legislation where specific definitions of manufacturer are applied, which might cover any natural or legal person who modifies a product already placed on the market in such a way that compliance with the applicable Union harmonisation legislation might be affected and places it on the market, or any other natural or legal person who places a product on the market under its name or trade mark. (12) Economic operators throughout the entire supply chain should be expected to act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market, so as to ensure compliance with the Union harmonisation legislation on products. This Regulation should be without prejudice to the obligations corresponding to the roles of each of the economic operators in the supply and distribution process pursuant to specific provisions in Union harmonisation legislation, and the manufacturer should retain ultimate responsibility for compliance of the product with requirements of the Union harmonisation legislation. (13) The challenges of the global market and increasingly complex supply chains, as well as the increase of products that are offered for sale online to end users within the Union, call for the strengthening of enforcement measures, to ensure the safety of consumers. Furthermore, practical experience of market surveillance has shown that such supply chains sometimes involve economic operators whose novel form means that they do not fit easily into the traditional supply chains according to the existing legal framework. Such is the case, in particular, with fulfilment service providers, which perform many of the same functions as importers but which might not always correspond to the traditional definition of importer in Union law. In order to ensure that market surveillance authorities can carry out their responsibilities effectively and to avoid a gap in the enforcement system, it is appropriate to include fulfilment service providers within the list of economic operators against whom it is possible for market surveillance authorities to take enforcement measures. By including fulfilment service providers within the scope of this Regulation, market surveillance authorities will be better able to deal with new forms of economic activity in order to ensure the safety of consumers and the smooth functioning of the internal market, including where the economic operator acts both as an importer as regards certain products and as a fulfilment service provider as regards other products. (14) Modern supply chains encompass a wide variety of economic operators who should all be subject to enforcement of Union harmonisation legislation, while taking due consideration of their respective roles in the supply chain, and the extent to which they contribute to the making available of products on the Union market. Therefore, it is necessary to apply this Regulation to economic operators that are directly concerned by Union harmonisation legislation listed in Annex I to this Regulation, such as the producer of an article and the downstream user as defined in Regulation (EC) No 1907/2006 of the European Parliament and of the Council (9) and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (10), the installer as defined in Directive 2014/33/EU of the European Parliament and of the Council (11), the supplier as defined in Regulation (EC) No 1222/2009 of the European Parliament and of the Council (12) or the dealer as defined in Regulation (EU) 2017/1369 of the European Parliament and of the Council (13). (15) In the case of a product offered for sale online or through other means of distance sales, the product should be considered to have been made available on the market if the offer for sale is targeted at end users in the Union. In line with the applicable Union rules on private international law, a case-by-case analysis should be carried out in order to establish whether an offer is targeted at end users in the Union. An offer for sale should be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State. For the case-by-case analyses, relevant factors, such as the geographical areas to which dispatch is possible, the languages available, used for the offer or for ordering, or means of payment, need to be taken into consideration. In the case of online sales, the mere fact that the economic operators' or the intermediaries' website is accessible in the Member State in which the end user is established or domiciled is insufficient. (16) The development of e-commerce is also due, to a great extent, to the proliferation of information society service providers, usually through platforms and for remuneration, which offer intermediary services by storing third party content, without exercising control over that content, and therefore not acting on behalf of an economic operator. Removal of content regarding non-compliant products or, where this is not feasible, restricting access to non-compliant products offered through their services should be without prejudice to the rules laid down in Directive 2000/31/EC of the European Parliament and of the Council (14). In particular, no general obligation should be imposed on information society service providers to monitor the information which they transmit or store, nor should a general obligation be imposed upon them to actively seek facts or circumstances indicating illegal activity. Furthermore, hosting service providers should not be held liable as long as they do not have actual knowledge of illegal activity or information and are not aware of the facts or circumstances from which the illegal activity or information is apparent. (17) While this Regulation does not deal with the protection of intellectual property rights, it should nevertheless be borne in mind that often counterfeit products do not comply with the requirements set out in the Union harmonisation legislation, present risks to health and safety of end users, distort competition, endanger public interests and support other illegal activities. Therefore, Member States should continue taking effective measures to prevent counterfeit products from entering the Union market pursuant to Regulation (EU) No 608/2013 of the European Parliament and of the Council (15). (18) A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this end, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers and the market surveillance authorities is a key element, allowing immediate intervention and corrective action in relation to the product. It is important that, for certain products, there should be an economic operator established in the Union so that market surveillance authorities have someone to whom requests can be addressed, including requests for information regarding a product's compliance with Union harmonisation legislation, and who can cooperate with market surveillance authorities in making sure that immediate corrective action is taken to remedy instances of non-compliance. The economic operators who should perform those tasks are the manufacturer, or the importer when the manufacturer is not established in the Union, or an authorised representative mandated by the manufacturer for this purpose, or a fulfilment service provider established in the Union for products handled by it when no other economic operator is established in the Union. (19) The development of e-commerce poses certain challenges for market surveillance authorities with regard to the ensuring of compliance of products offered for sale online and the effective enforcement of Union harmonisation legislation. The number of economic operators offering products directly to consumers by electronic means is increasing. Therefore, economic operators with tasks regarding products subject to certain Union harmonisation legislation perform an essential role by providing market surveillance authorities with an interlocutor established in the Union, and by performing specific tasks in a timely manner to make sure that the products comply with the requirements of Union harmonisation legislation, for the benefit of consumers, other end users and businesses within the Union. (20) The obligations of the economic operator with tasks regarding products subject to certain Union harmonisation legislation should be without prejudice to existing obligations and responsibilities of manufacturer, importer and authorised representative under the relevant Union harmonisation legislation. (21) Obligations of this Regulation requiring an economic operator to be established in the Union in order to place products on the Union's market should only apply to areas where the need for an economic operator to act as a liaison point with the market surveillance authorities has been identified, taking into account a risk-based approach, having regard to the principle of proportionality, and taking into account high level of protection of end users in the Union. (22) Moreover, those obligations should not apply where the specific requirements set out in certain legal acts on products achieve in effect the same result, namely Regulation (EC) No 648/2004 of the European Parliament and of the Council (16), Regulation (EC) No 1223/2009, Regulation (EU) No 167/2013 of the European Parliament and of the Council (17), Regulation (EU) No 168/2013 of the European Parliament and of the Council (18), Directive 2014/28/EU of the European Parliament and of the Council (19), Directive 2014/90/EU of the European Parliament and of the Council (20), Regulation (EU) 2016/1628 of the European Parliament and of the Council (21), Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2017/1369 and Regulation (EU) 2018/858. Consideration should also be given to situations where potential risks or cases of non-compliance are low, or in which products are mainly traded through traditional supply chains, which is the case, for instance, for Directive 2014/33/EU, Regulation (EU) 2016/424 of the European Parliament and of the Council (22) and Directive 2010/35/EU of the European Parliament and of the Council (23). (23) Contact information of economic operators with tasks regarding products subject to certain Union harmonisation legislation should be indicated with the product in order to facilitate checks throughout the supply chain. (24) Economic operators should fully cooperate with market surveillance authorities and other competent authorities to ensure the smooth performance of market surveillance and to enable the authorities to perform their tasks. This includes, where requested by authorities, providing the contact information of the economic operators with tasks regarding products subject to certain Union harmonisation legislation where this information is available to them. (25) Economic operators should have easy access to high quality, comprehensive information. Since the single digital gateway established under Regulation (EU) 2018/1724 of the European Parliament and of the Council (24) provides for a single point of online access to information, it can be used in respect to providing relevant information on Union harmonisation legislation to economic operators. Nevertheless, Member States should put in place procedures for ensuring access to the Product Contact Points established under Regulation (EU) 2019/515 of the European Parliament and of the Council (25) in order to assist the economic operators in addressing properly their requests for information. Guidance on issues relating to technical specifications or harmonised standards or design of a specific product should not be part of the obligations of Member States when providing such information. (26) Market surveillance authorities might carry out joint activities with other authorities or organisations representing economic operators or end users, with a view to promoting compliance, identifying non-compliance, raising awareness and providing guidance on Union harmonisation legislation and with respect to specific categories of products, including those that are offered for sale online. (27) Member States should designate their own market surveillance authorities. This Regulation should not prevent Member States from choosing the competent authorities to carry out the market surveillance tasks. In order to facilitate administrative assistance and cooperation, Member States should also appoint a single liaison office. Single liaison offices should at least represent the coordinated position of the market surveillance authorities and the authorities in charge of the control on products entering the Union market. (28) E-commerce poses certain challenges for market surveillance authorities regarding the protection of the health and safety of end users from non-compliant products. Therefore, Member States should ensure their market surveillance is organised with the same effectiveness for products made available online as it is for products made available offline. (29) While performing market surveillance of products offered for sale online, market surveillance authorities are facing numerous difficulties, such as tracing products offered for sale online, identifying the responsible economic operators, or conducting risk-assessments or tests due to the lack of physical access to products. In addition to the requirements introduced by this Regulation, Member States are encouraged to use complementary guidance and best practices for market surveillance and for communication with businesses and consumers. (30) Special attention should be given to emerging technologies, taking into account that consumers are increasingly using connected devices in their daily lives. The Union regulatory framework should therefore address the new risks to ensure the safety of the end users. (31) In the age of constant development of digital technologies new solutions that could contribute to the effective market surveillance within the Union should be explored. (32) Market surveillance should be thorough and effective, to ensure that Union harmonisation legislation on products is applied correctly. Given that controls may represent a burden for economic operators, market surveillance authorities should organise and conduct inspection activities on a risk-based approach, taking the interests of those economic operators into account and limiting the said burden to what is necessary for the performance of efficient and effective controls. Furthermore, market surveillance should be performed with the same level of care by the competent authorities of the Member State irrespective of whether non-compliance of the given product is relevant on the territory of that Member State or is likely to have an impact on the market of another Member State. Uniform conditions for certain inspection activities carried out by the market surveillance authorities where products or categories of products present specific risks or seriously breach the applicable Union harmonisation legislation might be laid down by the Commission. (33) Market surveillance authorities, when performing their duties, are confronted with different shortcomings in terms of resources, coordination mechanisms, as well as powers with regard to non-compliant products. Such differences lead to fragmented enforcement of Union harmonisation legislation and to market surveillance being more rigorous in some Member States than in others, potentially compromising the level playing field among businesses and creating also potential imbalances in the level of product safety throughout the Union. (34) In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic operators from exploiting gaps in the enforcement system by relocating to Member States whose market surveillance authorities are not equipped to tackle unlawful practices. In particular, the powers should ensure that information and evidence can be exchanged between competent authorities so that enforcement can be undertaken equally in all Member States. (35) This Regulation should be without prejudice to the freedom of Member States to choose the enforcement system that they consider to be appropriate. Member States should be free to choose whether their market surveillance authorities can exercise investigation and enforcement directly under their own authority, by recourse to other public authorities or upon application to the competent courts. (36) Market surveillance authorities should be in a position to open investigations on their own initiative if they become aware of non-compliant products placed on the market. (37) Market surveillance authorities should have access to all necessary evidence, data and information relating to the subject matter of an investigation in order to determine whether applicable Union harmonisation legislation has been infringed, and in particular to identify the economic operator responsible, irrespective of who possesses the evidence, data or information in question and regardless of where it is located and of the format in which it is held. Market surveillance authorities should be able to request economic operators, including those in the digital value chain, to provide all the evidence, data and information necessary. (38) Market surveillance authorities should be able to carry out the necessary on-site inspections, and should have the power to enter any premises, land or means of transport, that the economic operator uses for purposes relating to its trade, business, craft or profession. (39) Market surveillance authorities should be able to require a representative or a relevant member of staff of the economic operator concerned to give explanations or provide facts, information or documents relating to the subject matter of the on-site inspection, and to record the answers given by that representative or relevant member of staff. (40) Market surveillance authorities should be able to check the compliance of products to be made available on the market with Union harmonisation legislation and to obtain evidence of non-compliance. They should, therefore, have the power to acquire products and, where the evidence cannot be obtained by other means, to purchase products under a cover identity. (41) In the digital environment in particular, market surveillance authorities should be able to bring non-compliance to an end quickly and effectively, notably where the economic operator selling the product conceals its identity or relocates within the Union or to a third country in order to avoid enforcement. In cases where there is a risk of serious and irreparable harm to end users due to non-compliance, market surveillance authorities should be able to take measures, where duly justified and proportionate and where there are no other means available to prevent or mitigate such harm, including, where necessary, requiring the removal of content from the online interface or the display of a warning. When such a request is not observed, the relevant authority should have the power to require information society service providers to restrict access to the online interface. These measures should be taken in accordance with the principles laid down in Directive 2000/31/EC. (42) The implementation of this Regulation and the exercise of powers in its application should also comply with other Union and national law, for example Directive 2000/31/EC, including with applicable procedural safeguards and principles of the fundamental rights. That implementation and that exercise of powers should also be proportionate and adequate in view of the nature and the overall actual or potential harm caused by the infringement. Competent authorities should take all facts and circumstances of the case into account and should choose the most appropriate measures, namely, those which are essential to address the infringement covered by this Regulation. Those measures should be proportionate, effective and dissuasive. Member States should remain free to set out conditions and limits for the exercise of the powers to fulfil duties in national law. Where, for example, in accordance with national law, prior authorisation to enter the premises of natural persons and legal persons is required from the judicial authority of the Member State concerned, the power to enter such premises should be used only after such prior authorisation has been obtained. (43) Market surveillance authorities act in the interest of economic operators, of end users, and of the public, to ensure that public interests covered by relevant Union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement measures, and that compliance with such legislation is ensured across the supply chain through appropriate checks, taking into consideration the fact that administrative checks alone, in many cases, cannot replace physical and laboratory checks in order to verify the compliance of products with the relevant Union harmonisation legislation. Consequently, market surveillance authorities should ensure a high level of transparency while performing their activities and should make available to the public any information that they consider to be relevant in order to protect the interests of end users in the Union. (44) This Regulation should be without prejudice to the functioning of RAPEX in accordance with Directive 2001/95/EC. (45) This Regulation should be without prejudice to the safeguard clause procedure provided for by sectoral Union harmonisation legislation, pursuant to Article 114(10) of the Treaty on the Functioning of the European Union. With a view to ensuring an equivalent level of protection throughout the Union, Member States are authorised to take measures in relation to products presenting a risk to health and safety, or other aspects of public interest protection. They are also required to notify those measures to other Member States and the Commission, allowing the Commission to take a position on whether national measures that restrict the free movement of products with a view to ensuring the functioning of the internal market are justified. (46) The exchange of information between market surveillance authorities, and the use of evidence and investigation findings should respect the principle of confidentiality. Information should be handled in accordance with applicable national law, in order to ensure that investigations are not compromised and that the reputation of the economic operator is not prejudiced. (47) Where, for the purposes of this Regulation, it is necessary to process personal data, this should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data under this Regulation is subject to Regulation (EU) 2016/679 of the European Parliament and of the Council (26) and Regulation (EU) 2018/1725 of the European Parliament and of the Council (27), as applicable. (48) To ensure the effectiveness and consistency of testing across the Union in the market surveillance framework with regard to specific products or a specific category or group of products or for specific risks related to a category or group of products, the Commission might designate testing facilities of its own or public testing facilities of a Member State as a Union testing facility. All Union testing facilities should be accredited in accordance with the requirements of Regulation (EC) No 765/2008. In order to avoid conflicts of interests, Union testing facilities should only provide services to market surveillance authorities, the Commission, the Union Product Compliance Network (the \u2018Network\u2019) and other government or intergovernmental entities. (49) Member States should ensure that adequate financial resources are always available for the appropriate staffing and equipping of the market surveillance authorities. Efficient market surveillance is demanding in terms of resources, and stable resources should be provided at a level appropriate to the enforcement needs at any given moment. Member States should have the possibility to supplement public financing by reclaiming from the relevant economic operators the costs incurred when performing market surveillance in relation to products that were found to be non-compliant. (50) Mechanisms for mutual assistance should be established, since it is imperative for the Union market for goods that the market surveillance authorities of the Member States cooperate with each other effectively. Authorities should act in good faith and, as a general principle, accept requests for mutual assistance, in particular those concerning access to EU declaration of conformity, declaration of performance and technical documentation. (51) It is appropriate that Member States designate the authorities responsible for applying the customs legislation and any other authorities in charge under national law of control on products entering the Union market. (52) An effective way to ensure that unsafe or non-compliant products are not placed on the Union market would be to detect such products before they are released for free circulation. Authorities in charge of the control on products entering the Union market have a complete overview of trade flows across the Union's external borders and should therefore be required to carry out adequate controls on a risk assessment basis to contribute to a safer market place which ensures a high level of protection of public interests. It is for Member States to designate the specific authorities that are to be responsible for the appropriate documentary and, where necessary, physical or laboratory checks of products before those products are released for free circulation. A uniform enforcement of Union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of information between market surveillance and other authorities designated as authorities in charge of the control on products entering the Union market. These authorities should receive well in advance from the market surveillance authorities all the necessary information concerning non-compliant products or information on economic operators where a higher risk of non-compliance has been identified. In turn, authorities in charge of the control on products entering the customs territory of the Union should inform the market surveillance authorities in a timely manner of the release of products for free circulation, and the results of controls, where such information is relevant for the enforcement of Union harmonisation legislation on products. Furthermore, where the Commission becomes aware of a serious risk presented by an imported product, it should inform the Member States about that risk in order to ensure coordinated and more effective compliance and enforcement controls at the first points of entry to the Union. (53) Importers should be reminded that Articles 220, 254, 256, 257 and 258 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (28) provide that products entering the Union market that require further processing in order to be in compliance with the applicable Union harmonisation legislation shall be placed under the appropriate customs procedure allowing such processing by the importer. Generally, the release for free circulation should not be deemed to be proof of conformity with Union law, since such a release does not necessarily include a complete check of compliance. (54) In order to use the EU Single Window environment for customs and therefore to optimise and unburden the data transfer between customs and market surveillance authorities, it is necessary to set up electronic interfaces that allow automatic data transfer. Customs and market surveillance authorities should contribute to determine the data to be transmitted. Additional burden for customs authorities should be limited and the interfaces should be highly automated and easy-to-use. (55) It is necessary to establish the Network, hosted by the Commission, aimed at structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and at streamlining the practices of market surveillance within the Union that facilitate the implementation of joint enforcement activities by Member States, such as joint investigations. This administrative support structure should allow the pooling of resources and maintain a communication and information system between Member States and the Commission, thereby helping to strengthen enforcement of Union harmonisation legislation on products and to deter infringements. The involvement of administrative cooperation groups (ADCOs) in the Network should not preclude the involvement of other, similar, groups involved in administrative cooperation. The Commission should provide the necessary administrative and financial support to the Network. (56) There should be effective, speedy and accurate exchange of information among the Member States and the Commission. A number of existing tools, such as the information and communication system for market surveillance (ICSMS) and RAPEX enable coordination among market surveillance authorities in the Union. These tools, together with the interface permitting data transfer from ICSMS into RAPEX should be maintained and further developed in order to exploit their full potential and help to increase the level of cooperation and exchange of information between Member States and the Commission. (57) In that context, for the purpose of collecting information relating to the enforcement of Union harmonisation legislation on products, ICSMS should be upgraded and be accessible to the Commission, single liaison offices, customs and market surveillance authorities. Furthermore, an electronic interface should be developed to allow effective exchange of information between national systems of customs and market surveillance authorities. With regard to the cases of mutual assistance requests, the single liaison offices should give any support necessary for cooperation between the relevant authorities. Therefore, ICSMS should provide the functions enabling an automated indication to the single liaison offices when deadlines are not met. When sectoral legislation already provides for electronic systems for cooperation and data exchange, as is the case for example of EUDAMED for medical devices, those systems should be kept in use, when appropriate. (58) In general, ICSMS should be used to exchange information considered helpful for other market surveillance authorities. This might include checks undertaken in the context of market surveillance projects, regardless of the outcome of the tests. The amount of data to be entered in ICSMS should strike a balance between imposing too great a burden, when the efforts for entering the data would exceed the work involved in doing the actual checks, and being comprehensive enough to support greater efficiency and effectiveness on the side of the authorities. Thus, the data entered in ICSMS should also cover simpler checks than laboratory tests only. Nevertheless, there should be no need to include brief visual checks. As a guideline, checks which are individually documented should also be entered in ICSMS. (59) Member States are encouraged to use ICSMS for interactions between customs and market surveillance authorities as an alternative to the national systems. This should not replace the Community Risk Management System (CRMS) used by customs authorities. These two systems could work in parallel since they fulfil different, complementary roles, with ICSMS facilitating communication between customs and market surveillance authorities in order to allow for a smooth treatment of customs declarations in the scope of the product safety and compliance framework while CRMS is for customs common risk management and controls. (60) Injuries caused by non-compliant products are important information for market surveillance authorities. ICSMS should therefore provide for related data fields so that market surveillance authorities can enter readily available reports provided for in the course of their investigations, thus facilitating later statistical evaluations. (61) The Commission should be able to exchange market surveillance related information with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Union and third countries or international organisations, with a view to ensuring compliance of products prior to their export to the Union market. (62) In order to achieve a high degree of compliance with applicable Union harmonisation legislation on products while at the same time ensuring an effective resource-allocation and a cost-efficient control of products entering the Union market, the Commission should be able to approve specific pre-export control systems. Products falling under such approved systems might, as part of the risk assessment performed by authorities in charge of controls on products entering the Union market, benefit from a higher level of confidence than comparable products which have not been subject to a pre-export control. (63) The Commission should carry out an evaluation of this Regulation in light of the objective it pursues, and taking into consideration new technological, economic, commercial and legal developments. Pursuant to point 22 of the Interinstitutional Agreement of 13 April 2016 on Better L aw Making (29), the evaluation, based on efficiency, effectiveness, relevance, coherence and value added, should provide the basis for impact assessments of options for further action, particularly as regards the scope of this Regulation, the application and enforcement of the provisions related to the tasks of economic operators placing products on the market, and the system of product-related pre-export controls. (64) The financial interests of the Union should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties. (65) The diversity of sanctions across the Union is one of the main reasons for inadequate deterrence and uneven protection. Rules on establishing sanctions, including monetary penalties, are a matter of national jurisdiction and should, therefore, be determined by national law. (66) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in relation to: determining the uniform conditions for checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of Union harmonisation legislation have been continuously identified; specifying the procedures for the designation of Union testing facilities; laying down benchmarks and techniques for checks on the basis of common risk analysis at the Union level; specifying the details of statistical data covering controls performed by the designated authorities with respect to products subject to Union law; specifying the details of implementation arrangements for the information and communication system and defining the data relating to the placing of products under the customs procedure \u2018release for free circulation\u2019 transmitted by customs authorities; and to the approval of specific systems of product-related pre-export controls and the withdrawal of such approvals. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (30). (67) Since the objective of this Regulation, namely to improve the functioning of the internal market by strengthening the market surveillance of products covered by Union harmonisation legislation, cannot be sufficiently achieved by the Member States given the need for a very high degree of cooperation, interaction and coherent action of all of the competent authorities in all Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (68) This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and present in the constitutional traditions of Member States. Accordingly, this Regulation should be interpreted and applied in accordance with those rights and principles, including those related to the freedom and pluralism of the media. In particular, this Regulation seeks to ensure full respect for consumer protection, the freedom to conduct a business, the freedom of expression and information, the right to property and the protection of personal data, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter 1. The objective of this Regulation is to improve the functioning of the internal market by strengthening the market surveillance of products covered by the Union harmonisation legislation referred to in Article 2, with a view to ensuring that only compliant products that fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, the protection of the environment and public security and any other public interests protected by that legislation, are made available on the Union market. 2. This Regulation lays down rules and procedures for economic operators regarding products subject to certain Union harmonisation legislation and establishes a framework for cooperation with economic operators. 3. This Regulation also provides a framework for controls on products entering the Union market. Article 2 Scope 1. This Regulation shall apply to products that are subject to the Union harmonisation legislation listed in Annex I (\u2018Union harmonisation legislation\u2019), in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement. 2. Articles 25 to 28 shall apply to products covered by Union law in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market in Union law. 3. The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC. 4. This Regulation is without prejudice to Articles 12 to 15 of Directive 2000/31/EC. Article 3 Definitions For the purposes of this Regulation, the following definitions shall apply: (1) \u2018making available on the market\u2019 means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (2) \u2018placing on the market\u2019 means the first making available of a product on the Union market; (3) \u2018market surveillance\u2019 means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation; (4) \u2018market surveillance authority\u2019 means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance in the territory of that Member State; (5) \u2018applicant authority\u2019 means the market surveillance authority that makes a request for mutual assistance; (6) \u2018requested authority\u2019 means the market surveillance authority that receives a request for mutual assistance; (7) \u2018non-compliance\u2019 means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation; (8) \u2018manufacturer\u2019 means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark; (9) \u2018importer\u2019 means any natural or legal person established within the Union who places a product from a third country on the Union market; (10) \u2018distributor\u2019 means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; (11) \u2018fulfilment service provider\u2019 means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council (31), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council (32), and any other postal services or freight transport services; (12) \u2018authorised representative\u2019 means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation; (13) \u2018economic operator\u2019 means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation; (14) \u2018information society service provider\u2019 means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (33); (15) \u2018online interface\u2019 means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator's products; (16) \u2018corrective action\u2019 means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative; (17) \u2018voluntary measure\u2019 means a corrective action where not required by a market surveillance authority; (18) \u2018risk\u2019 means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm; (19) \u2018product presenting a risk\u2019 means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisation legislation, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements; (20) \u2018product presenting a serious risk\u2019 means a product presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate; (21) \u2018end user\u2019 means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities; (22) \u2018recall\u2019 means any measure aimed at achieving the return of a product that has already been made available to the end user; (23) \u2018withdrawal\u2019 means any measure aimed at preventing a product in the supply chain from being made available on the market; (24) \u2018customs authorities\u2019 means customs authorities as defined in point 1 of Article 5 of Regulation (EU) No 952/2013; (25) \u2018release for free circulation\u2019 means the procedure laid down in Article 201 of Regulation (EU) No 952/2013; (26) \u2018products entering the Union market\u2019 means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure \u2018release for free circulation\u2019. CHAPTER II TASKS OF ECONOMIC OPERATORS Article 4 Tasks of economic operators regarding products subject to certain Union harmonisation legislation 1. Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product. 2. For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following: (a) a manufacturer established in the Union; (b) an importer, where the manufacturer is not established in the Union; (c) an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer's behalf; (d) a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union. 3. Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks: (a) if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request; (b) further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority; (c) when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof; (d) cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements set out in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk. 4. Without prejudice to the respective obligations of economic operators under the applicable Union harmonisation legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document. 5. This Article only applies in relation to products that are subject to Regulations (EU) No 305/2011 (34), (EU) 2016/425 (35) and (EU) 2016/426 (36) of the European Parliament and of the Council, and Directives 2000/14/EC (37), 2006/42/EC (38), 2009/48/EC (39), 2009/125/EC (40), 2011/65/EU (41), 2013/29/EU (42), 2013/53/EU (43), 2014/29/EU (44), 2014/30/EU (45), 2014/31/EU (46), 2014/32/EU (47), 2014/34/EU (48), 2014/35/EU (49), 2014/53/EU (50) and 2014/68/EU (51) of the European Parliament and of the Council. Article 5 Authorised representative 1. For the purposes of point (c) of Article 4(2), the authorised representative shall be mandated by the manufacturer to perform the tasks listed in Article 4(3), notwithstanding any other tasks mandated under the relevant Union harmonisation legislation. 2. The authorised representative shall perform the tasks specified in the mandate. It shall provide a copy of the mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority. 3. Authorised representatives shall have the appropriate means to be able to fulfil their tasks. Article 6 Distance sales Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale shall be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State. Article 7 Obligation of cooperation 1. Economic operators shall cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market by those operators. 2. Information society service providers shall cooperate with the market surveillance authorities, at the request of the market surveillance authorities and in specific cases, to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a product that is or was offered for sale online through their services. CHAPTER III ASSISTANCE TO AND COOPERATION WITH ECONOMIC OPERATORS Article 8 Information to economic operators 1. The Commission, in accordance with Regulation (EU) 2018/1724, shall ensure that the Your Europe portal provides users with easy online access to information about the product requirements and rights, obligations and rules derived from the Union harmonisation legislation. 2. Member States shall put in place procedures for providing economic operators, at their request and free of charge, with information with respect to the national transposition and implementation of Union harmonisation legislation applicable to products. For this purpose, Article 9(1), (4) and (5) of Regulation (EU) 2019/515 shall apply. Article 9 Joint activities to promote compliance 1. Market surveillance authorities may agree with other relevant authorities or with organisations representing economic operators or end users on the carrying out of joint activities that have the aim of promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to the Union harmonisation legislation with respect to specific categories of products, in particular categories of products that are often found to present a serious risk, including products offered for sale online. 2. The market surveillance authority in question and the parties referred to in paragraph 1 shall ensure that the agreement on joint activities does not lead to unfair competition between economic operators and does not affect the objectivity, independence and impartiality of the parties. 3. A market surveillance authority may use any information resulting from joint activities carried out as part of any investigation regarding non-compliance that it undertakes. 4. The market surveillance authority in question shall make the agreement on joint activities, including the names of the parties involved, available to the public and shall enter that agreement in the information and communication system referred to in Article 34. At the request of a Member State, the Network established under Article 29 shall assist in the drawing up of the agreement on joint activities. CHAPTER IV ORGANISATION, ACTIVITIES AND OBLIGATIONS OF MARKET SURVEILLANCE AUTHORITIES AND THE SINGLE LIAISON OFFICE Article 10 Designation of market surveillance authorities and the single liaison office 1. Member States shall organise and carry out market surveillance as provided for in this Regulation. 2. For the purposes of paragraph 1 of this Article, each Member State shall designate one or more market surveillance authorities in its territory. Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities, using the information and communication system referred to in Article 34. 3. Each Member State shall appoint a single liaison office. 4. The single liaison office shall at least be responsible for representing the coordinated position of the market surveillance authorities and the authorities designated under Article 25(1) and for communicating the national strategies as set out in Article 13. The single liaison office shall also assist in the cooperation between market surveillance authorities in different Member States, as set out in Chapter VI. 5. In order to carry out market surveillance of products made available online and offline with the same effectiveness for all distribution channels, Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary and other resources, such as a sufficient number of competent personnel, expertise, procedures and other arrangements for the proper performance of their duties. 6. Where there is more than one market surveillance authority in their territory, Member States shall ensure that the respective duties of those authorities are clearly defined and that appropriate communication and coordination mechanisms are established to enable those authorities to collaborate closely and exercise their duties effectively. Article 11 Activities of market surveillance authorities 1. Market surveillance authorities shall conduct their activities in order to ensure the following: (a) effective market surveillance within their territory of products made available online and offline with respect to products that are subject to Union harmonisation legislation; (b) the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this Regulation; (c) the taking of appropriate and proportionate measures where the economic operator fails to take corrective action. 2. Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias. 3. Market surveillance authorities, as part of their activities set out in paragraph 1 of this Article, shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks based on adequate samples, prioritising their resources and actions to ensure effective market surveillance and taking into account the national market surveillance strategy referred to in Article 13. In deciding on which checks to perform, on which types of products and on what scale, market surveillance authorities shall follow a risk-based approach taking into account the following factors: (a) possible hazards and non-compliance associated with the products and, where available, their occurrence on the market; (b) activities and operations under the control of the economic operator; (c) the economic operator's past record of non-compliance; (d) if relevant, the risk profiling performed by the authorities designated under Article 25(1); (e) consumer complaints and other information received from other authorities, economic operators, media and other sources that might indicate non-compliance. 4. The Commission, after consulting the Network, may adopt implementing acts determining the uniform conditions of checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of applicable Union harmonisation legislation have been continuously identified, in order to ensure high level of protection of health and safety or other public interests protected by that legislation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). 5. Where economic operators present test reports or certificates attesting the conformity of their products with Union harmonisation legislation issued by a conformity assessment body accredited in accordance with Regulation (EC) No 765/2008, market surveillance authorities shall take due account of those reports or certificates. 6. Evidence that is used by a market surveillance authority in one Member State may be used as part of investigations to verify product compliance carried out by market surveillance authorities in another Member State, without any further formal requirements. 7. Market surveillance authorities shall establish the following procedures in connection with products subject to the Union harmonisation legislation: (a) procedures for following up on complaints or reports on issues relating to risks or non-compliance; (b) procedures for verifying that the corrective action that was to be taken by economic operators has been taken. 8. With a view to ensuring communication and coordination with their counterparts in other Member States, market surveillance authorities shall actively participate in administrative cooperation groups (ADCOs) as referred to in Article 30(2). 9. Without prejudice to any Union safeguard procedure pursuant to the applicable Union harmonisation legislation, products that have been deemed to be non-compliant on the basis of a decision of a market surveillance authority in one Member State shall be presumed to be non-compliant by market surveillance authorities in other Member States, unless a relevant market surveillance authority in another Member State concluded the contrary on the basis of its own investigation, taking into account the input, if any, provided by an economic operator. Article 12 Peer reviews 1. Peer reviews shall be organised for market surveillance authorities wishing to participate in such reviews, in order to strengthen consistency in market surveillance activities in relation to the application of this Regulation. 2. The Network shall develop the methodology and the rolling plan for peer reviews among participating market surveillance authorities. When establishing the methodology and the rolling plan, the Network shall take into consideration, at least, the number and the size of market surveillance authorities in the Member States, the number of personnel available and other resources for performing the peer review, and other relevant criteria. 3. Peer reviews shall cover best practices developed by some market surveillance authorities which may be of benefit for other market surveillance authorities, and other relevant aspects related to the effectiveness of market surveillance activities. 4. The outcome of the peer reviews shall be reported to the Network. Article 13 National market surveillance strategies 1. Each Member State shall draw up an overarching national market surveillance strategy, at least every four years. Each Member State shall draw up the first such strategy by 16 July 2022. The national strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and to the enforcement of Union harmonisation legislation within the territory of the Member State. When drawing up the national market surveillance strategy, all sectors covered by the Union harmonisation legislation and all stages of the product supply chain, including imports and digital supply chains, shall be considered. The priorities set out within the work programme of the Network may also be considered. 2. The national market surveillance strategy shall include at least the following elements, when this does not compromise market surveillance activities: (a) the available information on the occurrence of non-compliant products, in particular taking into account the checks and controls referred to in Articles 11(3) and 25(3), respectively, and, where applicable, market trends that may affect non-compliance rates for the categories of products, and possible threats and risks related to emerging technologies; (b) the areas identified by the Member States as priorities for the enforcement of Union harmonisation legislation; (c) the enforcement activities planned in order to reduce non-compliance in those areas identified as priorities, including, where relevant, the minimum control levels envisaged for categories of products which have significant levels of non-compliance; (d) an assessment of the cooperation with market surveillance authorities in other Member States, as referred to in Article 11(8) and Chapter VI. 3. Member States shall communicate their national market surveillance strategy to the Commission and other Member States through the information and communication system referred to in Article 34. Each Member State shall publish a summary of its strategy. CHAPTER V MARKET SURVEILLANCE POWERS AND MEASURES Article 14 Powers of market surveillance authorities 1. Member States shall confer on their market surveillance authorities the powers of market surveillance, investigation and enforcement necessary for the application of this Regulation and for the application of Union harmonisation legislation. 2. Market surveillance authorities shall exercise the powers set out in this Article efficiently and effectively, in accordance with the principle of proportionality, to the extent that such exercise relates to the subject matter and the purpose of the measures and the nature and the overall actual or potential harm resulting from the instance of non-compliance. Powers shall be conferred and exercised in accordance with Union and national law, including the principles of the Charter of Fundamental Rights of the European Union, as well as with principles of national law relating to freedom of expression and the freedom and pluralism of the media, with applicable procedural safeguards and with the Union rules on data protection, in particular Regulation (EU) 2016/679. 3. When conferring powers under paragraph 1, Member States may provide for the power to be exercisable in one of the following ways, as appropriate: (a) directly by the market surveillance authorities under their own authority; (b) by recourse to other public authorities in accordance with the division of powers and the institutional and administrative organisation of the Member State in question; (c) upon application to courts competent to grant the necessary decision to approve the exercise of that power, including, where appropriate, on appeal, if the application to grant the necessary decision was not successful. 4. The powers conferred on market surveillance authorities under paragraph 1 shall include at least the following: (a) the power to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product's compliance with applicable Union harmonisation legislation, in any form or format and irrespective of the medium of storage or the place where such documents, technical specifications, data or information are stored, and to take or obtain copies thereof; (b) the power to require economic operators to provide relevant information on the supply chain, on the details of the distribution network, on quantities of products on the market and on other product models that have the same technical characteristics as the product in question, where relevant for compliance with the applicable requirements under Union harmonisation legislation; (c) the power to require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites, where the information in question is related to the subject matter of the investigation; (d) the power to carry out unannounced on-site inspections and physical checks of products; (e) the power to enter any premises, land or means of transport that the economic operator in question uses for purposes related to the economic operator's trade, business, craft or profession, in order to identify non-compliance and to obtain evidence; (f) the power to start investigations on market surveillance authorities' own initiative in order to identify non-compliances and bring them to an end; (g) the power to require economic operators to take appropriate action to bring an instance of non-compliance to an end or to eliminate the risk; (h) the power to take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including the power to prohibit or restrict the making available of a product on the market or to order that the product is withdrawn or recalled; (i) the power to impose penalties in accordance with Article 41; (j) the power to acquire product samples, including under a cover identity, to inspect those samples and to reverse-engineer them in order to identify non-compliance and to obtain evidence; (k) the power, where no other effective means are available to eliminate a serious risk: (i) to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface; or (ii) where a request according to point (i) has not been complied with, to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures. 5. Market surveillance authorities may use any information, document, finding, statement, or any intelligence as evidence for the purpose of their investigations, irrespective of the format in which and medium on which they are stored. Article 15 Recovery of costs by market surveillance authorities 1. Member States may authorise their market surveillance authorities to reclaim from the relevant economic operator the totality of the costs of their activities with respect to instances of non-compliance. 2. The costs referred to in paragraph 1 of this Article may include the costs of carrying out testing, the costs of taking measures in accordance with Article 28(1) and (2), the costs of storage and the costs of activities relating to products that are found to be non-compliant and are subject to corrective action prior to their release for free circulation or their placing on the market. Article 16 Market surveillance measures 1. Market surveillance authorities shall take appropriate measures if a product subject to Union harmonisation legislation, when used in accordance with its intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained: (a) is liable to compromise the health or safety of users; or (b) does not conform to applicable Union harmonisation legislation. 2. Where market surveillance authorities make findings referred to in point (a) or (b) of paragraph 1, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk within a period they specify. 3. For the purposes of paragraph 2, the corrective action required to be taken by the economic operator may include, inter alia: (a) bringing the product into compliance, including by rectifying formal non-compliance as defined by the applicable Union harmonisation legislation, or by ensuring that the product no longer presents a risk; (b) preventing the product from being made available on the market; (c) withdrawing or recalling the product immediately and alerting the public to the risk presented; (d) destroying the product or otherwise rendering it inoperable; (e) affixing to the product suitable, clearly worded, easily comprehensible warnings of the risks that it might present, in the language or languages determined by the Member State in which the product is made available on the market; (f) setting prior conditions for making the product concerned available on the market; (g) alerting the end users at risk immediately and in an appropriate form, including by publication of special warnings in the language or languages determined by the Member State in which the product is made available on the market. 4. Corrective actions referred to in points (e), (f) and (g) of paragraph 3 may only be required in cases where the product is liable to present a risk only in certain conditions or only to certain end users. 5. If the economic operator fails to take corrective action referred to in paragraph 3 or where the non-compliance or the risk referred to in paragraph 1 persists, market surveillance authorities shall ensure that the product is withdrawn or recalled, or that its being made available on the market is prohibited or restricted, and that the public, the Commission and the other Member States are informed accordingly. 6. The information to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34. That communication of information shall also be deemed to fulfil notification requirements for the applicable safeguard procedures of Union harmonisation legislation. 7. Where a national measure is considered to be justified in accordance with the applicable safeguard procedure, or where no market surveillance authority of another Member State concluded the contrary as referred to in Article 11(9), the competent market surveillance authorities in the other Member States shall take the necessary measures in respect of the non-compliant product and shall enter the relevant information in the information and communication system referred to in Article 34. Article 17 Use of information, professional and commercial secrecy Market surveillance authorities shall perform their activities with a high level of transparency and shall make available to the public any information that they consider to be relevant in order to protect the interests of end users. Market surveillance authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union and national law. Article 18 Procedural rights of economic operators 1. Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or this Regulation shall state the exact grounds on which it is based. 2. Any such measure, decision or order shall be communicated without delay to the relevant economic operator, who shall at the same time be informed of the remedies available to it under the law of the Member State concerned and of the time limits to which those remedies are subject. 3. Before a measure, decision or order referred to in paragraph 1 is taken or made, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 working days, unless it is not possible to give the economic operator that opportunity because of the urgency of the measure, decision or order, based on health or safety requirements or other grounds relating to the public interests covered by the relevant Union harmonisation legislation. If the measure, decision or order is taken or made without the economic operator being given the opportunity to be heard, the economic operator shall be given that opportunity as soon as possible thereafter and that measure, decision or order shall be reviewed promptly by the market surveillance authority. Article 19 Products presenting a serious risk 1. Market surveillance authorities shall ensure that products presenting a serious risk are withdrawn or recalled, where there is no other effective means available to eliminate the serious risk, or that their being made available on the market is prohibited. Market surveillance authorities shall notify the Commission thereof immediately, in accordance with Article 20. 2. A decision whether or not a product presents a serious risk shall be based on an appropriate risk assessment that takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety and the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk. Article 20 Rapid Information Exchange System 1. Where a market surveillance authority takes or intends to take a measure pursuant to Article 19 and considers that the reasons which prompted the measure or the effects of the measure go beyond the territory of its Member State, it shall immediately notify the Commission of that measure in accordance with paragraph 4 of this Article. The market surveillance authority shall also inform the Commission without delay of the modification or withdrawal of any such measure. 2. If a product presenting a serious risk has been made available on the market, market surveillance authorities shall immediately notify the Commission of any voluntary measures taken and communicated to the market surveillance authority by an economic operator. 3. The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the risk related to the product, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators. 4. For the purposes of paragraphs 1, 2 and 3 of this Article, the Rapid Information Exchange System (RAPEX) provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis. 5. The Commission shall provide and maintain a data interface between RAPEX and the information and communication system referred to in Article 34 so as to avoid double data entry. Article 21 Union testing facilities 1. The objective of the Union testing facilities is to contribute to enhancing laboratory capacity, as well as to ensuring the reliability and consistency of testing, for the purposes of market surveillance within the Union. 2. For the purposes of paragraph 1, the Commission may designate a public testing facility of a Member State as a Union testing facility for specific categories of products or for specific risks related to a category of products. The Commission may also designate one of its own testing facilities as a Union testing facility for specific categories of products or for specific risks related to a category of products, or for products for which testing capacity is missing or is not sufficient. 3. Union testing facilities shall be accredited in accordance with Regulation (EC) No 765/2008. 4. The designation of Union testing facilities shall not affect the freedom of market surveillance authorities, the Network and the Commission to choose testing facilities for the purpose of their activities. 5. Designated Union testing facilities shall provide their services solely to market surveillance authorities, the Network, the Commission and other government or intergovernmental entities. 6. Union testing facilities shall, within the area of their competence, perform the following activities: (a) carry out testing of products at the request of market surveillance authorities, the Network or the Commission; (b) provide independent technical or scientific advice at the request of the Network; (c) develop new techniques and methods of analysis. 7. The activities referred to in paragraph 6 of this Article shall be remunerated and may be financed by the Union in accordance with Article 36(2). 8. Union testing facilities may receive financing by the Union in accordance with Article 36(2) in order to increase their testing capacity or to create new testing capacity for specific categories of products or for specific risks related to a category of products for which the testing capacity is missing or is insufficient. 9. The Commission shall adopt implementing acts specifying the procedures for the designation of Union testing facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). CHAPTER VI CROSS-BORDER MUTUAL ASSISTANCE Article 22 Mutual Assistance 1. There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, and between market surveillance authorities and the Commission and the relevant Union agencies. 2. When a market surveillance authority is unable to conclude its investigation because of its inability to access certain information, despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the market surveillance authority of another Member State where access to this information can be enforced. In this case the requested authority shall supply to the applicant authority without delay, and in any event within 30 days, any information that the requested authority considers to be relevant in order to establish whether a product is non-compliant. 3. The requested authority shall undertake appropriate investigations or take any other measures that are appropriate in order to gather the requested information. Where necessary, those investigations shall be carried out with the assistance of other market surveillance authorities. 4. The applicant authority shall remain responsible for any investigation that it has initiated, unless the requested authority agrees to take over responsibility. 5. In duly justified cases, a requested authority may refuse to comply with a request for information under paragraph 2 where: (a) the applicant authority has not sufficiently substantiated that the requested information is necessary in order to establish non-compliance; (b) the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities. Article 23 Requests for enforcement measures 1. Where bringing non-compliance with regard to a product to an end requires measures within the jurisdiction of another Member State and where such measures do not result from the requirements of Article 16(7), an applicant authority may submit a duly reasoned request for enforcement measures to a requested authority in that other Member State. 2. The requested authority shall without delay take all appropriate and necessary enforcement measures using the powers conferred on it under this Regulation in order to bring the instance of non-compliance to an end by exercising the powers laid down in Article 14 and any additional powers granted to it under national law. 3. The requested authority shall inform the applicant authority about the measures referred to in paragraph 2 that have been taken or which are intended to be taken. A requested authority may refuse to comply with a request for enforcement measures in any of the following situations: (a) the requested authority concludes that the applicant authority has not provided sufficient information; (b) the requested authority considers that the request is contrary to Union harmonisation legislation; (c) the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities. Article 24 Procedure for mutual assistance requests 1. Before submitting a request under Article 22 or 23, the applicant authority shall endeavour to carry out all reasonable possible investigations. 2. When submitting a request under Article 22 or 23, the applicant authority shall provide all available information in order to enable the requested authority to fulfil the request, including any necessary evidence obtainable only in the Member State of the applicant authority. 3. Requests under Articles 22 and 23 and all communication related to them shall be made using electronic standard forms by means of the information and communication system referred to in Article 34. 4. Communication shall take place directly between the involved market surveillance authorities or through the single liaison offices of the Member States concerned. 5. The languages to be used for requests under Articles 22 and 23 and for all communication linked to them shall be agreed upon by the market surveillance authorities concerned. 6. Where no agreement about the languages to be used can be reached between the market surveillance authorities concerned, the requests under Articles 22 and 23 shall be sent in the official language of the Member State of the applicant authority, and the replies to such requests shall be sent in the official language of the Member State of the requested authority. In such case, the applicant authority and the requested authority shall arrange for the translation of the requests, replies or other documents that it receives from the other authority. 7. The information and communication system referred to in Article 34 shall provide structured information on mutual assistance cases to the single liaison offices involved. Using this information, single liaison offices shall provide any support that is necessary to facilitate assistance. CHAPTER VII PRODUCTS ENTERING THE UNION MARKET Article 25 Controls on products entering the Union market 1. Member States shall designate customs authorities, one or more market surveillance authorities or any other authority in their territory as the authorities in charge of the control on products entering the Union market. Each Member State shall inform the Commission and the other Member States of the authorities designated under the first subparagraph and of their areas of competence through the information and communication system referred to in Article 34. 2. The authorities designated under paragraph 1 shall have the necessary powers and resources for the proper performance of their tasks as referred to in that paragraph. 3. Products subject to Union law that are to be placed under the customs procedure \u2018release for free circulation\u2019 shall be subject to controls performed by the authorities designated under paragraph 1 of this Article. They shall perform those controls on the basis of risk analysis in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013 and, where relevant, on the basis of risk-based approach as referred to in the second subparagraph of Article 11(3) of this Regulation. 4. Risk-related information shall be exchanged between: (a) the authorities designated under paragraph 1 of this Article in accordance with Article 47(2) of Regulation (EU) No 952/2013; and (b) customs authorities in accordance with Article 46(5) of Regulation (EU) No 952/2013. Where, in relation to products subject to Union law that are either in temporary storage or placed under a customs procedure other than \u2018release for free circulation\u2019, customs authorities at the first point of entry have reason to believe that those products are not compliant with applicable Union law or present a risk, they shall transmit all relevant information to the competent customs office of destination. 5. Market surveillance authorities shall provide authorities designated under paragraph 1 with information on categories of products or the identity of economic operators where a higher risk of non-compliance has been identified. 6. By 31 March of each year, Member States shall submit to the Commission detailed statistical data covering controls performed by the authorities designated under paragraph 1 with respect to products subject to Union law during the previous calendar year. The statistical data shall cover the number of interventions in the field of controls on such products with regard to product safety and compliance. The Commission shall draw up a report by 30 June of each year, containing the information provided by the Member States for the previous calendar year and an analysis of the data submitted. The report shall be published in the information and communication system referred to in Article 34. 7. Where the Commission becomes aware of a serious risk presented by products subject to Union law that are imported from a third country, it shall recommend to the Member State concerned to take appropriate market surveillance measures. 8. The Commission, after consulting the Network, may adopt implementing acts laying down benchmarks and techniques for checks on the basis of common risk analysis on the Union level, in order to ensure a consistent enforcement of Union law, to strengthen the controls on products entering the Union market and to ensure an effective and uniform level of such controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). 9. The Commission shall adopt implementing acts further specifying the details of the data to be submitted under paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). Article 26 Suspension of release for free circulation 1. Authorities designated under Article 25(1) shall suspend the release of a product for free circulation if in the course of controls pursuant to Article 25(3), it is established that: (a) the product is not accompanied by the documentation required by the Union law applicable to it or there is a reasonable doubt as to the authenticity, accuracy or completeness of such documentation; (b) the product is not marked or labelled in accordance with the Union law applicable to it; (c) the product bears a CE marking or other marking required by the Union law applicable to it which has been affixed in a false or misleading manner; (d) the name, registered trade name or registered trade mark and the contact details, including the postal address, of an economic operator with tasks regarding the product subject to certain Union harmonisation legislation is not indicated or identifiable in accordance with Article 4(4); or (e) for any other reason, when there is cause to believe that the product does not comply with the Union law applicable to it or that it presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1. 2. Authorities designated under Article 25(1) shall immediately notify the market surveillance authorities of any suspension of release referred to in paragraph 1 of this Article. 3. Where the market surveillance authorities have reasonable grounds to believe that a product does not comply with the Union law applicable to it or presents a serious risk, they shall request the authorities designated under Article 25(1) to suspend the process for its release for free circulation. 4. Notifications under paragraph 2 and requests under paragraph 3 of this Article may take place by means of the information and communication system referred to in Article 34, including through the use of electronic interfaces between this system and systems used by customs authorities, when they are available. Article 27 Release for free circulation Where the release of a product for free circulation has been suspended in accordance with Article 26, that product shall be released for free circulation where all the other requirements and formalities relating to such a release have been fulfilled and where either of the following conditions is satisfied: (a) within four working days of the suspension, the authorities designated under Article 25(1) have not been requested by the market surveillance authorities to maintain the suspension; (b) the authorities designated under Article 25(1) have been informed by the market surveillance authorities of its approval for release for free circulation. The release for free circulation shall not be deemed to be proof of conformity with Union law. Article 28 Refusal to release for free circulation 1. Where the market surveillance authorities conclude that a product presents a serious risk, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require these authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document: \u2018Dangerous product \u2014 release for free circulation not authorised \u2014 Regulation (EU) 2019/1020\u2019. Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34. 2. Where market surveillance authorities conclude that a product may not be placed on the market since it does not comply with the Union law applicable to it, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require those authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document: \u2018Product not in conformity \u2014 release for free circulation not authorised \u2014 Regulation (EU) 2019/1020\u2019. Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34. 3. Where the product referred to in paragraph 1 or 2 is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the notice required by paragraph 1 or 2 shall also be included, under the same conditions as required by paragraph 1 or 2, in the documents used in connection with that procedure. 4. Authorities designated under Article 25(1) may destroy or otherwise render inoperable a product which presents a risk to the health and safety of end users where the authority in question considers that it is necessary and proportionate to do so. The cost of such measure shall be borne by the natural or legal person declaring the product for free circulation. Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly. CHAPTER VIII COORDINATED ENFORCEMENT AND INTERNATIONAL COOPERATION Article 29 Union Product Compliance Network 1. A Union Product Compliance Network (\u2018the Network\u2019) is hereby established. 2. The purpose of the Network is to serve as a platform for structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective. Article 30 Composition and functioning of the Network 1. The Network shall be composed of representatives from each Member State, including a representative of each single liaison office referred to in Article 10 and an optional national expert, the chairs of ADCOs, and representatives from the Commission. 2. Separate or joint ADCOs shall be established for the uniform application of Union harmonisation legislation. ADCOs shall be composed of representatives of the national market surveillance authorities and, if appropriate, representatives of the single liaison offices. ADCOs meetings are intended only for representatives of market surveillance authorities and the Commission. Relevant stakeholders, such as organisations representing the interests of industry, small and medium-sized enterprises (SMEs), consumers, testing laboratories, standardisation and conformity assessment bodies at Union level, may be invited to attend the ADCOs meetings depending on the subject matter of discussion. 3. The Commission shall support and encourage cooperation between market surveillance authorities through the Network and participate in the meetings of the Network, its sub-groups and the ADCOs. 4. The Network shall meet at regular intervals and, where necessary, at the reasoned request of the Commission or a Member State. 5. The Network may establish standing or temporary sub-groups dealing with specific questions and tasks. 6. The Network may invite experts and other third parties, including the organisations representing the interests of industry, SMEs, consumers, testing laboratories, standardisation and conformity assessment bodies at Union level, to attend meetings as observers or to provide written contributions. 7. The Network shall use its best endeavours to reach consensus. Decisions taken by the Network shall be legally non-binding recommendations. 8. The Network shall establish its own rules of procedure. Article 31 Role and tasks of the Network 1. In carrying out the tasks set out in paragraph 2, the Network shall address general, horizontal issues of market surveillance with a view to facilitating the cooperation among single liaison offices, as well as the Commission. 2. The Network shall have the following tasks: (a) to prepare, adopt and monitor the implementation of its work programme; (b) to facilitate the identification of common priorities for market surveillance activities and the exchange of information across sectors on evaluations of products, including risk assessment, test methods and results, recent scientific developments and new technologies, emerging risks and other aspects relevant to control activities and on the implementation of national market surveillance strategies and activities; (c) to coordinate ADCOs and their activities; (d) to organise cross-sector joint market surveillance and testing projects and define their priorities; (e) to exchange expertise and best practices, in particular regarding the implementation of national market surveillance strategies; (f) to facilitate the organisation of training programmes and exchanges of personnel; (g) in collaboration with the Commission, to organise information campaigns and voluntary mutual visit programmes between market surveillance authorities; (h) to discuss questions arising from cross-border mutual assistance mechanisms; (i) to contribute to the development of guidance to ensure the effective and uniform application of this Regulation; (j) to propose the financing of activities referred to in Article 36; (k) to contribute to uniform administrative practices with regard to market surveillance in the Member States; (l) to provide advice and assist the Commission with issues related to the further development of RAPEX and the information and communication system referred to in Article 34; (m) to promote the cooperation and exchange of expertise and best practices between market surveillance authorities and authorities in charge of controls at the Union's external borders; (n) to promote and facilitate collaboration with other relevant networks and groups, with a view to explore possibilities for using new technologies for the purposes of market surveillance and traceability of products; (o) to evaluate regularly the national market surveillance strategies, the first such evaluation taking place by 16 July 2024; (p) to take up any other issues in activities within the remit of the Network, with the aim of contributing to the effective functioning of market surveillance within the Union. Article 32 Role and tasks of administrative cooperation groups 1. In carrying out the tasks set out in paragraph 2, ADCOs shall address specific matters related to market surveillance and sector specific issues. 2. ADCOs shall have the following tasks: (a) to facilitate the uniform application of Union harmonisation legislation within their area of competence with a view to increasing the efficiency of market surveillance throughout the internal market; (b) to promote communication between market surveillance authorities and the Network and develop mutual confidence between market surveillance authorities; (c) to establish and coordinate common projects, such as cross-border joint market surveillance activities; (d) to develop common practices and methodologies for effective market surveillance; (e) to inform each other of national market surveillance methods and activities and to develop and promote best practices; (f) to identify issues of shared interest relating to market surveillance and suggest common approaches to be adopted; (g) to facilitate sector-specific evaluations of products, including risk assessments, test methods and results, recent scientific developments and other aspects relevant to control activities. Article 33 Role and tasks of the Commission The Commission shall have the following tasks: (a) to assist the Network, its sub-groups, and the ADCOs by means of an executive secretariat that provides technical and logistic support; (b) to keep and make available to the single liaison offices and ADCO chairs an updated list of ADCO chairs, including their contact information; (c) to assist the Network in preparing and monitoring its work programme; (d) to support the functioning of the Product Contact Points having duties assigned by Member States in relation to Union harmonisation legislation; (e) to determine, in consultation with the Network, the need for additional testing capacity and to propose solutions for that purpose, in accordance with Article 21; (f) to apply the instruments of international cooperation referred to in Article 35; (g) to provide support for the establishment of separate or joint ADCOs; (h) to develop and maintain the information and communication system referred to in Article 34, including the interface referred to in Article 34(7), as well as the interface with national market surveillance databases, and provide information to the public by means of that system; (i) to assist the Network to perform preliminary or ancillary work in connection with the implementation of market surveillance activities linked to the application of Union harmonisation legislation, such as studies, programmes, evaluations, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work; (j) to prepare and assist in the implementation of Union market surveillance campaigns and similar activities; (k) to organise joint market surveillance and testing projects, and common training programmes, to facilitate exchanges of personnel between market surveillance authorities and, where appropriate, with the market surveillance authorities of third countries or with international organisations, and to organise information campaigns and voluntary mutual visit programmes between market surveillance authorities; (l) to carry out activities under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems among interested parties at Union and international level; (m) to facilitate technical or scientific expertise for the purpose of implementing market surveillance administrative cooperation; (n) to examine, at the request of the Network or on its own initiative, any question covering the application of this Regulation and issue guidelines, recommendations and best practices in order to encourage consistent application of this Regulation. Article 34 Information and communication system 1. The Commission shall further develop and maintain an information and communication system for the collection, processing and storage of information, in a structured form, on issues relating to the enforcement of Union harmonisation legislation, with the aim of improving the sharing of data among Member States, including for the purpose of requests for information, providing a comprehensive overview of market surveillance activities, results and trends. The Commission, market surveillance authorities, single liaison offices, and authorities designated under Article 25(1) shall have access to that system. The Commission shall develop and maintain the public user interface of this system, where key information for end-users about market surveillance activities shall be provided. 2. The Commission shall further develop and maintain electronic interfaces between the system referred to in paragraph 1 and national market surveillance systems. 3. Single liaison offices shall enter the following information in the information and communication system: (a) the identity of the market surveillance authorities in their Member State and areas of competence of those authorities pursuant to Article 10(2); (b) the identity of the authorities designated under Article 25(1); (c) the national market surveillance strategy drawn up by their Member State under Article 13 and the results from the review and assessment of the market surveillance strategy. 4. Market surveillance authorities shall enter into the information and communication system in relation to products made available on the market for which an in-depth check of compliance has been carried out, without prejudice to Article 12 of Directive 2001/95/EC and Article 20 of this Regulation, and where applicable, in relation to products entering the Union market for which the process for the release for free circulation has been suspended in accordance with Article 26 of this Regulation, in their territory, the following information concerning: (a) measures according to Article 16(5) taken by that market surveillance authority; (b) reports of testing carried out by them; (c) corrective action taken by economic operators concerned; (d) readily available reports on injuries caused by the product in question; (e) any objection raised by a Member State in accordance with the applicable safeguard procedure in the Union harmonisation legislation applicable to the product and any subsequent follow-up; (f) where available, failures by authorised representatives to comply with Article 5(2); (g) where available, failures by manufacturers to comply with Article 5(1). 5. Where market surveillance authorities consider it useful, they may enter into the information and communication system any additional information related to the checks they perform and results of testing carried out by them or at their request. 6. Where relevant for the enforcement of Union harmonisation legislation and for the purpose of minimising risk, customs authorities shall extract from national customs systems information on products placed under the customs procedure \u2018release for free circulation\u2019 related to the enforcement of Union harmonisation legislation and transmit it to the information and communication system. 7. The Commission shall develop an electronic interface to enable the transmission of data between national customs systems and the information and communication system. This interface shall be in place within four years from the date of adoption of the relevant implementing act referred to in paragraph 8. 8. The Commission shall adopt implementing acts specifying the details of implementation arrangements for paragraphs 1 to 7 of this Article, and in particular the data processing to be applied on data collected in accordance with paragraph 1 of this Article, and defining the data to be transmitted in accordance with paragraphs 6 and 7 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). Article 35 International cooperation 1. In order to improve the efficiency of market surveillance in the Union, the Commission may cooperate with and exchange market surveillance related information with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Union and third countries or international organisations. Any such agreements shall be based on reciprocity, include provisions on confidentiality corresponding to those applicable in the Union, and ensure that any exchange of information is in accordance with applicable Union law. 2. The cooperation or exchange of information may relate, inter alia, to the following: (a) risk assessment methods used and the results of product-testing; (b) coordinated product recalls or other similar actions; (c) the measures taken by market surveillance authorities under Article 16. 3. The Commission may approve a specific system of product-related pre-export control carried out by a third country on products immediately prior to their export into the Union in order to verify that those products satisfy the requirements of the Union harmonisation legislation applicable to them. The approval may be granted in respect of one or more products, in respect of one or more categories of products or in respect of products or categories of products manufactured by certain manufacturers. 4. The Commission shall produce and maintain a list of those products or categories of products with regard to which approval has been granted as referred to in paragraph 3 and shall make this list available to the public. 5. Approval may only be granted to a third country under paragraph 3 if following conditions are satisfied: (a) the third country possesses an efficient verification system of the compliance of products exported to the Union, and the controls carried out in that third country are sufficiently effective and efficient to replace or reduce import controls; (b) audits within the Union and, if relevant, in the third country demonstrate that products exported from that third country to the Union satisfy the requirements set out in Union harmonisation legislation. 6. Where such an approval has been granted, the risk assessment applied to import controls for those products or categories of products entering the Union market, referred to in paragraph 3, shall include the granted approvals. Authorities designated under Article 25(1) may however carry out controls on those products or categories of products entering the Union market, including in order to ensure that the pre-export controls carried out by the third country are effective to determine compliance with Union harmonisation legislation. 7. The approval referred to in paragraph 3 shall specify the competent authority of the third country under whose responsibility the pre-export controls are to be performed and that competent authority shall be the counterpart for all contacts with the Union. 8. The competent authority, referred to in paragraph 7, shall ensure the official verification of the products prior to their entry into the Union. 9. Where controls on products entering the Union market referred to in paragraph 3 of this Article reveal significant non-compliance, the market surveillance authorities shall notify immediately the Commission through the information and communication system referred to in Article 34 and adapt the level of controls on such products. 10. The Commission shall adopt implementing acts approving each specific system of product-related pre-export controls, referred to in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). 11. The Commission shall regularly monitor the correct functioning of the approval granted under paragraph 3 of this Article. The Commission shall adopt implementing acts withdrawing that approval where it is revealed that the products entering the Union market do not comply with Union harmonisation legislation in a significant number of instances. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). The Commission shall immediately inform the third country concerned thereof. 12. The system of product-related pre-export control shall be evaluated in accordance with Article 42(4). CHAPTER IX FINANCIAL PROVISIONS Article 36 Financing activities 1. The Union shall finance performance of the tasks of the Network referred to in Article 31 and the peer reviews referred to in Article 12. 2. The Union may finance the following activities in relation to the application of this Regulation: (a) the functioning of the Product Contact Points; (b) the establishment and functioning of Union testing facilities referred to in Article 21; (c) the development of instruments of international cooperation referred to in Article 35; (d) the drawing up and updating of contributions to guidelines on market surveillance; (e) the making available to the Commission of technical or scientific expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation; (f) the implementation of national market surveillance strategies referred to in Article 13; (g) Member States' and Union market surveillance campaigns and associated activities, including resources and equipment, IT tools and training; (h) the performance of preliminary or ancillary work in connection with market surveillance activities related to the application of Union harmonisation legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work; (i) activities carried out under programmes providing technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems amongst interested parties at Union and international level. 3. The Union shall finance the electronic interface referred to in Article 34(7), including the development of the information and communication system referred to in Article 34 to enable it to receive automatic flows of electronic data from the national customs systems. 4. The Union shall finance the electronic interfaces referred to in Article 34(2) enabling the exchange of data between the information and communication system referred to in Article 34 and the national market surveillance systems. 5. The Union's financial assistance with respect to the activities in support of this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (52), either directly, or by entrusting budget implementation tasks to the entities listed in point (c) of Article 62(1) of that Regulation. 6. The appropriations allocated to activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force. 7. The appropriations determined by the budgetary authority for the financing of market surveillance activities may also cover expenses relating to preparatory work, monitoring, control, audit and evaluation activities which are required for the management of the activities set out in this Regulation and for the achievement of their objectives. These expenses shall include the costs of conducting studies, arranging meetings of experts, information and communication activities, including corporate communication of the political priorities of the Union in so far as they are related to the general objectives of market surveillance activities, expenses linked to information technology networks focusing on information processing and exchange together with all other related technical and administrative assistance expenses incurred by the Commission. Article 37 Protection of the financial interests of the Union 1. The Commission shall take appropriate measures to ensure that, when activities financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective controls and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties. 2. The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds under this Regulation. 3. The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot controls and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (53) and Council Regulation (Euratom, EC) No 2185/96 (54) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under this Regulation. 4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences. CHAPTER X AMENDMENTS Article 38 Amendments to Directive 2004/42/EC Articles 6 and 7 of Directive 2004/42/EC of the European Parliament and of the Council (55) are deleted. Article 39 Amendments to Regulation (EC) No 765/2008 1. Regulation (EC) No 765/2008 is amended as follows: (1) the title is replaced by the following: \u2018Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93\u2019; (2) in Article 1, paragraphs 2 and 3 are deleted; (3) in Article 2, points 1, 2, 14, 15, 17, 18 and 19 are deleted; (4) Chapter III, containing Articles 15 to 29, is deleted; (5) paragraph 1 of Article 32 is amended as follows: (a) point (c) is replaced by the following: \u2018(c) the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies and conformity assessment;\u2019; (b) points (d) and (e) are deleted; (c) points (f) and (g) are replaced by the following: \u2018(f) the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology and accreditation activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work; (g) activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment and accreditation policies and systems among interested parties in the Community and at international level.\u2019 2. References to the deleted provisions of Regulation (EC) No 765/2008 shall be construed as references to the provisions of this Regulation and shall be read in accordance with the correlation table in Annex III to this Regulation. Article 40 Amendments to Regulation (EU) No 305/2011 In Article 56(1) of Regulation (EU) No 305/2011, the first subparagraph is replaced by the following: \u20181. Where the market surveillance authorities of one Member State have sufficient reason to believe that a construction product covered by a harmonised standard or for which a European Technical Assessment has been issued does not achieve the declared performance and presents a risk for the fulfilment of the basic requirements for construction works covered by this Regulation, they shall carry out an evaluation in relation to the product concerned covering the respective requirements laid down by this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.\u2019 CHAPTER XI FINAL PROVISIONS Article 41 Penalties 1. The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and of Union harmonisation legislation listed in Annex II that impose obligations on economic operators and shall take all measures necessary to ensure that they are implemented in accordance with national law. 2. The penalties provided for shall be effective, proportionate and dissuasive. 3. The Member States shall, by 16 October 2021, notify those provisions to the Commission, where they have not previously been notified, and shall notify it, without delay, of any subsequent amendment affecting them. Article 42 Evaluation, review and guidelines 1. By 31 December 2026 and every five years thereafter, the Commission shall carry out an evaluation of this Regulation in light of the objectives that it pursues and shall present a report thereon to the European Parliament, to the Council and to the European Economic and Social Committee. 2. The report shall assess whether this Regulation achieved its objective, in particular with regard to reducing the number of non-compliant products on the Union market, ensuring effective and efficient enforcement of Union harmonisation legislation within the Union, improving cooperation between competent authorities and strengthening the controls on products entering the Union market, while taking into account the impact on business and in particular on SMEs. In addition, the evaluation shall also assess the scope of this Regulation, the effectiveness of the peer review system and of the market surveillance activities that receive Union financing in the light of the requirements of Union policies and law and the possibilities to further improve the cooperation between the market surveillance authorities and customs authorities. 3. By 16 July 2023, the Commission shall prepare an evaluation report on the implementation of Article 4. The report shall in particular evaluate the scope of that Article, its effects and its costs and benefits. The report shall be accompanied, where appropriate, by a legislative proposal. 4. Within four years after the first approval of a specific system of product-related pre-export control referred to in Article 35(3), the Commission shall carry out an evaluation of its effects and cost efficiency. 5. In order to facilitate the implementation of this Regulation, the Commission shall draw up guidelines for the practical implementation of Article 4 for the purposes of market surveillance authorities and economic operators. Article 43 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act in respect of the implementing powers referred to in Article 11(4), Article 21(9), Article 25(8), Article 35(10) and Article 35(11) of this Regulation, and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 44 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 16 July 2021. However, Articles 29, 30, 31, 32, 33 and 36 shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 283, 10.8.2018, p. 19. (2) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and decision of the Council of 14 June 2019. (3) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). (4) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). (5) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). (6) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1). (7) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). (8) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (9) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). (10) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (11) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251). (12) Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46). (13) Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1). (14) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). (15) Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15). (16) Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1). (17) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1). (18) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52). (19) Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1). (20) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146). (21) Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53). (22) Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1). (23) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1). (24) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1). (25) Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1). (26) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (27) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (28) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (29) OJ L 123, 12.5.2016, p. 1. (30) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (31) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14). (32) Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19). (33) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (34) Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5). (35) Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51). (36) Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99). (37) Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1). (38) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24). (39) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1). (40) Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10). (41) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88). (42) Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27). (43) Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90). (44) Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45). (45) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). (46) Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107). (47) Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149). (48) Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309). (49) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357). (50) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). (51) Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164). (52) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (53) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (54) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (55) Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87). ANNEX I List of Union harmonisation legislation 1. Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36); 2. Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16); 3. Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14); 4. Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40); 5. Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1); 6. Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40); 7. Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17); 8. Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37); 9. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10); 10. Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58); 11. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1); 12. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1); 13. Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles (OJ L 269, 21.10.2000, p. 34); 14. Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1); 15. Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1); 16. Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7); 17. Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87); 18. Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10); 19. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24); 20. Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12); 21. Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1); 22. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1); 23. Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1); 24. Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17); 25. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1); 26. Regulation (EC) No 78/2009 of the European Parliament and of the Council of 14 January 2009 on the type-approval of motor vehicles with regard to the protection of pedestrians and other vulnerable road users, amending Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC (OJ L 35, 4.2.2009, p. 1); 27. Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14 January 2009 on type-approval of hydrogen-powered motor vehicles, and amending Directive 2007/46/EC (OJ L 35, 4.2.2009, p. 32); 28. Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (OJ L 106, 28.4.2009, p. 7); 29. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1); 30. Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, p. 1); 31. Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1); 32. Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10); 33. Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1); 34. Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46); 35. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59); 36. Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L 27, 30.1.2010, p. 1); 37. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1); 38. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5); 39. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88); 40. Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (OJ L 272, 18.10.2011, p. 1); 41. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1); 42. Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38); 43. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1); 44. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52); 45. Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27); 46. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90); 47. Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1); 48. Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45); 49. Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79); 50. Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107); 51. Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149); 52. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251); 53. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309); 54. Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357); 55. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1); 56. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62); 57. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164); 58. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146); 59. Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, p. 195); 60. Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 April 2014 on the sound level of motor vehicles and of replacement silencing systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC (OJ L 158, 27.5.2014, p. 131); 61. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1); 62. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51); 63. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99); 64. Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53); 65. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1); 66. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176); 67. Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1); 68. Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1); 69. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1); 70. Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1), in so far as the design, production and placing on the market of aircrafts referred to in points (a) and (b) of Article 2(1) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned. ANNEX II List of Union harmonisation legislation without provisions on penalties 1. Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36); 2. Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16); 3. Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14); 4. Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40); 5. Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1); 6. Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17); 7. Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37); 8. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10); 9. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1); 10. Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34); 11. Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10); 12. Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12); 13. Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17); 14. Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46); 15. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1); 16. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5); 17. Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (OJ L 272, 18.10.2011, p. 1); 18. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146); 19. Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 April 2014 on the sound level of motor vehicles and of replacement silencing systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC (OJ L 158, 27.5.2014, p. 131). ANNEX III Correlation table Regulation (EC) No 765/2008 This Regulation Article 1(2) Article 1(1) Article 1(3) Article 1(3) Article 2, point 1 Article 3, point 1 Article 2, point 2 Article 3, point 2 Article 2, point 14 Article 3, point 22 Article 2, point 15 Article 3, point 23 Article 2, point 17 Article 3, point 3 Article 2, point 18 Article 3, point 4 Article 2, point 19 Article 3, point 25 Article 15(1) and (2) Article 2(1) Article 15(3) Article 2(3) Article 15(4) \u2014 Article 15(5) Article 2(2) Article 16(1) Article 10(1) Article 16(2) Article 16(5) Article 16(3) \u2014 Article 16(4) \u2014 Article 17(1) Article 10(2) Article 17(2) Article 34(1), last sentence and Article 34(3), point (a) Article 18(1) Article 10(6) Article 18(2), point (a) Article 11(7), point (a) Article 18(2), point (b) \u2014 Article 18(2), point (c) Article 11(7), point (b) Article 18(2), point (d) \u2014 Article 18(3) Articles 10(5) and 14(1) Article 18(4) Article 14(2) Article 18(5) Article 13 Article 18(6) Article 31(2), point (o) Article 19(1), first subparagraph Article 11(3) Article 19(1), second subparagraph Article 14(4), points (a), (b), (e) and (j) Article 19(1), third subparagraph Article 11(5) Article 19(2) Article 16(3), point (g) Article 19(3) Article 18(2) Article 19(4) Article 11(2) Article 19(5) Article 17 Article 20(1) Article 19(1) Article 20(2) Article 19(2) Article 21(1) Article 18(1) Article 21(2) Article 18(2) Article 21(3) Article 18(3) Article 21(4) \u2014 Article 22(1) Article 20(1) Article 22(2) Article 20(2) Article 22(3) Article 20(3) Article 22(4) Article 20(4) Article 23(1) and (3) Article 34(1) Article 23(2) Article 34(4) Article 24(1) Article 22(1) Article 24(2) Article 22(2) to (5) Article 24(3) \u2014 Article 24(4) \u2014 Article 25(1) \u2014 Article 25(2), point (a) Article 31(2), point (f) and Article 33(1), points (i) and (k) Article 25(2), point (b) Article 31(2), points (g) and (m) and Article 33(1), points (i) and (k) Article 25(3) \u2014 Article 26 \u2014 Article 27(1), first sentence Article 25(2) Article 27(1), second sentence Article 25(3) Article 27(2) Article 25(4) Article 27(3), first subparagraph Article 26(1) Article 27(3), second subparagraph Article 26(2) Article 27(4) \u2014 Article 27(5) \u2014 Article 28(1) Article 27, first paragraph, point (a) Article 28(2) Article 27, first paragraph, point (b) Article 29(1) Article 28(1) Article 29(2) Article 28(2) Article 29(3) Article 28(3) Article 29(4) Article 28(4) Article 29(5) Article 25(5) Article 32(1), point (d) \u2014 Article 32(1), point (e) Article 36(2), point (e)", "summary": "Market surveillance and compliance of products Market surveillance and compliance of products SUMMARY OF: Regulation (EU) 2019/1020 \u2014 market surveillance and compliance of products WHAT IS THE AIM OF THE REGULATION? It aims to improve how the free movement of goods principle works by strengthening market surveillance* of products covered by EU hamonisation legislation. This must ensure a high level of protection of health and safety, in general and in the workplace, and protect consumers, the environment, public security and other public interest. It lays down rules and procedures for economic operators* and establishes a system for their cooperation with supervisory authorities. It establishes controls on products imported into the EU. It deletes and replaces Articles 15 to 29 of Regulation (EC) No 765/2008 (see summary on Accreditation and market surveillance) and amends Directive 2004/42/EC and Regulation (EU) No 305/2011 (see summary on Construction products). KEY POINTS The regulation applies to products: covered by EU harmonisation legislation (and set out in Annex I); imported into the EU which are not subject to specific legislation. Certain products may not be offered for sale to EU consumers without an economic operator established in the EU: who keeps EU conformity and performance declarations and makes these and the technical documentation available to authorities when asked; who informs the authorities when they consider a product poses a risk; who cooperates with the authorities, when asked, by taking immediate corrective action \u2014 from remedying the fault to recall or destroying the item \u2014 if a product is considered non-compliant, and helps to eliminate or mitigate risks; whose name and contact details are on the product, packaging or accompanying document. Market surveillance authorities: carry out effective surveillance of products sold online and offline; perform appropriate documentary, physical and laboratory checks on products, taking into account possible hazards; act when a product, properly installed, maintained and used for its intended purpose: could damage users\u2019 health and safety,does not conform to EU legislation; ensure economic operators take corrective action when instructed and act when they fail to do so; establish procedures to follow up complaints and reports and to verify economic operators have taken corrective action; apply a high level of transparency and make available to the public any information they consider relevant to protect end users\u2019 interests; provide economic operators with grounds for their decisions to give them an opportunity to respond; notify the European Commission and the other EU countries immediately of any measures they take if these could have an impact in other EU countries; may ask colleagues elsewhere in the EU to help with investigations and enforcement and participate in peer reviews to improve the system\u2019s overall efficiency; have powers to: start investigations on their own initiative,require economic operators to provide relevant documents, data and information on supply chains, distribution networks, product models and ownership of websites,carry out unannounced onsite inspections and physical checks,enter any premises, land or means of transport an economic operator uses,acquire product samples without revealing their identity,instruct economic operators to take measures to end non-compliance or eliminate risk,prohibit or restrict availability of a product and order it be withdrawn or recalled,insist in case of serious risk that product content is removed from a website or require it be accompanied by a warning,adopt measures, including penalties, against economic operators that fail to act. EU countries: designate one or more authorities with the powers of market surveillance, investigation and enforcement; appoint a single liaison office to represent the surveillance authorities and communicate the country\u2019s national strategy; ensure the authorities and office have sufficient budgetary and other resources; may authorise surveillance authorities to reclaim from an economic operator all the costs they incur when pursuing non-compliance cases; draw up an overarching national market surveillance strategy every 4 years from 16 July 2022 to promote a consistent, comprehensive and integrated approach to market surveillance \u2014 this must include: data on non-compliant products,priority areas for enforcing the EU legislation,enforcement activities to reduce non-compliance,assessment of cooperation between authorities in other EU countries; provide economic operators, at their request and free of charge, information on national implementation of EU product harmonisation legislation; introduce effective, proportionate and dissuasive penalties and notify these to the Commission by 16 October 2021. The Commission: ensures the Your Europe portal provides users with easy online access to information about the EU\u2019s product requirements, rights, obligations and rules; adopts implementing acts; assists the EU Product Compliance Network (see below) in all its activities; maintains a computer system to store and process all the data collected; reports to the European Parliament, the Council and the European Economic and Social Committee by 31 December 2026, and every 5 years thereafter, on the regulation\u2019s implementation. Specific rules apply to imported products: EU countries designate authorities with the necessary powers to check imports; market surveillance authorities provide them with information on products and economic operators where a high risk of non-compliance has been identified; authorities may impound a product if the necessary documentation is absent or there are concerns it presents a serious health, safety, environmental or public interest risk, and only release it when certain conditions are met. The regulation: establishes an EU Product Compliance Network \u2014 it: develops cooperation between the surveillance authorities and the Commission;contains national and Commission representatives and experts;organises a range of activities to improve market surveillance across the EU. FROM WHEN DOES THE REGULATION APPLY? It applies from 16 July 2021. However, Articles 29, 30, 31, 32, 33 (on the EU Product Compliance Network) and 36 (on financing activities) apply from 1 January 2021. BACKGROUND For more information, see: Market surveillance for products (European Commission). KEY TERMS Market surveillance: measures to ensure products comply with EU legislation and protect the public interest. Economic operator: manufacturer, authorised representative, importer, distributor or fulfilment service provider. MAIN DOCUMENT Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1-44) RELATED DOCUMENTS Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, pp. 5-43) Successive amendments to Regulation (EU) No 305/2011 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30-47) Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, pp. 87-96) See consolidated version. last update 30.08.2019"}
{"article": "17.5.2019 EN Official Journal of the European Union L 130/82 DIRECTIVE (EU) 2019/789 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 April 2019 laying down rules on the exercise of copyright and related rights applicable to certain online transmissions of broadcasting organisations and retransmissions of television and radio programmes, and amending Council Directive 93/83/EEC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 53(1) and Article 62 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) In order to contribute to the proper functioning of the internal market, it is necessary to provide for wider dissemination in Member States of television and radio programmes that originate in other Member States, for the benefit of users across the Union, by facilitating the licensing of copyright and related rights in works and other protected subject matter contained in broadcasts of certain types of television and radio programmes. Television and radio programmes are important means of promoting cultural and linguistic diversity and social cohesion, and of increasing access to information. (2) The development of digital technologies and the internet has transformed the distribution of, and access to, television and radio programmes. Users increasingly expect to have access to television and radio programmes, both live and on-demand, through traditional channels, such as satellite or cable, and also through online services. Broadcasting organisations are therefore increasingly offering, in addition to their own broadcasts of television and radio programmes, online services ancillary to such broadcasts, such as simulcasting and catch-up services. Operators of retransmission services, which aggregate broadcasts of television and radio programmes into packages and provide them to users simultaneously with the initial transmission of those broadcasts, unaltered and unabridged, use various techniques of retransmission, such as cable, satellite, digital terrestrial, and mobile or closed circuit IP-based networks, as well as the open internet. Furthermore, operators that distribute television and radio programmes to users have different ways of obtaining the programme-carrying signals of broadcasting organisations, including by means of direct injection. There is a growing demand, on the part of users, for access to broadcasts of television and radio programmes not only originating in their Member State, but also in other Member States. Such users include members of linguistic minorities in the Union, as well as persons who live in a Member State other than their Member State of origin. (3) Broadcasting organisations transmit daily many hours of television and radio programmes. Those programmes incorporate a variety of content, such as audiovisual, musical, literary or graphic works, protected under Union law by copyright or related rights or both. That results in a complex process of clearing the rights of a multitude of rightholders, and for various categories of works and other protected subject matter. Often the rights need to be cleared in a short time frame, in particular when preparing programmes such as news or current affairs programmes. In order to make their online services available across borders, broadcasting organisations need to have the required rights to works and other protected subject matter for all the relevant territories, which further increases the complexity of the clearance of such rights. (4) Operators of retransmission services typically offer multiple programmes comprising a multitude of works and other protected subject matter and have a very short time frame for obtaining the necessary licences and, hence, face a significant rights clearance burden. Authors, producers and other rightholders also risk having their works and other protected subject matter used without authorisation or payment of appropriate remuneration. Such remuneration for the retransmission of their works and other protected subject matter is important to ensure that there is a diverse content offer, which is also in the interest of consumers. (5) The rights in works and other protected subject matter are harmonised, inter alia, through Directive 2001/29/EC of the European Parliament and of the Council (3) and Directive 2006/115/EC of the European Parliament and of the Council (4), which provide for a high level of protection for rightholders. (6) Council Directive 93/83/EEC (5) facilitates cross-border satellite broadcasting and retransmission by cable of television and radio programmes from other Member States. However, the provisions of that Directive on transmissions of broadcasting organisations are limited to satellite transmissions and, therefore, do not apply to online services ancillary to broadcasts. Furthermore, the provisions concerning retransmissions of television and radio programmes from other Member States are limited to simultaneous, unaltered and unabridged retransmission by cable or microwave systems and do not cover retransmissions by means of other technologies. (7) Accordingly, cross-border provision of online services that are ancillary to broadcasts, and retransmissions of television and radio programmes originating in other Member States, should be facilitated by adapting the legal framework on the exercise of copyright and related rights relevant for those activities. That adaptation should be done by taking account of the financing and production of creative content, and, in particular, of audiovisual works. (8) This Directive should cover ancillary online services offered by a broadcasting organisation, which have a clear and subordinate relationship with the broadcasting organisation's broadcasts. Those services include services that give access to television and radio programmes in a strictly linear manner, simultaneously to the broadcast, and services that give access, within a defined time period after the broadcast, to television and radio programmes which have been previously broadcast by the broadcasting organisation, so-called \u2018catch-up services\u2019. In addition, the ancillary online services covered by this Directive include services that give access to material that enriches or otherwise expands television and radio programmes broadcast by the broadcasting organisation, including by way of previewing, extending, supplementing or reviewing the relevant programme's content. This Directive should apply to ancillary online services that are provided to users by broadcasting organisations together with the broadcasting service. It should also apply to ancillary online services that, while having a clear and subordinate relationship with the broadcast, can be accessed by users separately from the broadcasting service without there being a precondition for the users to have to obtain access to that broadcasting service, for example via a subscription. This does not affect the freedom of broadcasting organisations to offer such ancillary online services free of charge or against payment. The provision of access to individual works or other protected subject matter that have been incorporated in a television or radio programme, or to works or other protected subject matter that are not related to any programme broadcast by the broadcasting organisation, such as services giving access to individual musical or audiovisual works, music albums or videos, for example video-on-demand services, should not fall within the scope of the services covered by this Directive. (9) In order to facilitate the clearance of rights for the provision of ancillary online services across borders, it is necessary to provide for the establishment of the country of origin principle as regards the exercise of copyright and related rights relevant for acts that occur in the course of the provision of, the access to or the use of an ancillary online service. That principle should cover the clearance of all rights that are necessary for a broadcasting organisation to be able to communicate to the public or make available to the public its programmes when providing ancillary online services, including the clearance of any copyright and related rights in the works or other protected subject matter used in the programmes, for example the rights in phonograms or performances. That country of origin principle should apply exclusively to the relationship between rightholders, or entities representing rightholders, such as collective management organisations, and broadcasting organisations, and solely for the purpose of the provision of, the access to or the use of an ancillary online service. The country of origin principle should not apply to any subsequent communication to the public of works or other protected subject matter, by wire or wireless means, or to any subsequent making available to the public of works or other protected subject matter, by wire or wireless means, in such a way that members of the public may access them from a place and at a time individually chosen by them, or to any subsequent reproduction of the works or other protected subject matter which are contained in the ancillary online service. (10) Given the specificities of the financing and licensing mechanisms for certain audiovisual works, which are often based on exclusive territorial licensing, it is appropriate, as regards television programmes, to limit the scope of application of the country of origin principle set out in this Directive to certain types of programmes. Those types of programmes should include news and current affairs programmes as well as a broadcasting organisation's own productions which are exclusively financed by it, including where the funds for the financing used by the broadcasting organisation for its productions come from public funds. For the purposes of this Directive, broadcasting organisations' own productions should be understood as covering productions carried out by a broadcasting organisation with the use of its own resources, but excluding productions commissioned by the broadcasting organisation to producers that are independent from the broadcasting organisation and co-productions. For the same reasons, the country of origin principle should not apply to television broadcasts of sports events under this Directive. The country of origin principle should apply only when programmes are used by the broadcasting organisation in its own ancillary online services. It should not apply to the licensing of a broadcasting organisation's own productions to third parties, including to other broadcasting organisations. The country of origin principle should not affect the freedom of rightholders and broadcasting organisations to agree, in compliance with Union law, on limitations, including territorial limitations, to the exploitation of their rights. (11) The country of origin principle set out in this Directive should not result in any obligation for broadcasting organisations to communicate or make available to the public programmes in their ancillary online services, or to provide such ancillary online services in a Member State other than the Member State of their principal establishment. (12) Since the provision of, the access to or the use of an ancillary online service is, under this Directive, deemed to occur solely in the Member State in which the broadcasting organisation has its principal establishment, while, de facto, the ancillary online service can be provided across borders to other Member States, it is necessary to ensure that in setting the amount of the payment to be made for the rights in question, the parties take into account all aspects of the ancillary online service, such as the features of the service, including the duration of the online availability of programmes included in the service, the audience, including the audience in the Member State in which the broadcasting organisation has its principal establishment and in other Member States in which the ancillary online service is accessed and used, and the language versions provided. It should nevertheless remain possible to use specific methods for calculating the amount of payment for the rights subject to the country of origin principle, such as methods based on the revenues of the broadcasting organisation generated by the online service, which are used, in particular, by radio broadcasting organisations. (13) On account of the principle of contractual freedom, it will remain possible to limit the exploitation of the rights affected by the country of origin principle set out in this Directive, provided that any such limitation is in compliance with Union law. (14) Operators of retransmission services can use different technologies when they retransmit simultaneously, in an unaltered and unabridged manner, for reception by the public, an initial transmission from another Member State of television or radio programmes. The programme-carrying signals can be obtained by operators of retransmission services from broadcasting organisations, which themselves transmit those signals to the public, in different ways, for example by capturing the signals transmitted by the broadcasting organisations or receiving the signals directly from them through the technical process of direct injection. Such operators' services can be offered on satellite, digital terrestrial, mobile or closed circuit IP-based and similar networks or through internet access services as defined in Regulation (EU) 2015/2120 of the European Parliament and of the Council (6). Operators of retransmission services using such technologies for their retransmissions should therefore be covered by this Directive and benefit from the mechanism that introduces mandatory collective management of rights. In order to ensure that there are sufficient safeguards against the unauthorised use of works and other protected subject matter, which is particularly important in the case of services that are paid for, retransmission services which are offered through internet access services should be included in the scope of this Directive only where those retransmission services are provided in an environment in which only authorised users can access the retransmissions and the level of content security provided is comparable to the level of security for content transmitted over managed networks, such as cable or closed circuit IP-based networks, in which content that is retransmitted is encrypted. Those requirements should be feasible and adequate. (15) To retransmit initial transmissions of television and radio programmes, operators of retransmission services have to obtain an authorisation from the holders of the exclusive right of communication to the public of works or other protected subject matter. In order to provide legal certainty to the operators of retransmission services and to overcome disparities in national law regarding such retransmission services, rules similar to those that apply to cable retransmission as defined in Directive 93/83/EEC should apply. The rules under that Directive include the obligation to exercise the right to grant or refuse authorisation to an operator of a retransmission service through a collective management organisation. Under those rules, the right to grant or refuse authorisation as such remains intact, and only the exercise of that right is regulated to some extent. Rightholders should receive appropriate remuneration for the retransmission of their works and other protected subject matter. When determining reasonable licensing terms, including the license fee, for a retransmission in accordance with Directive 2014/26/EU of the European Parliament and of the Council (7), the economic value of the use of the rights in trade, including the value allocated to the means of retransmission, should, inter alia, be taken into account. This should be without prejudice to the collective exercise of the right to payment of a single equitable remuneration for performers and phonogram producers for the communication to the public of commercial phonograms as provided for in Article 8(2) of Directive 2006/115/EC, and to Directive 2014/26/EU, in particular its provisions concerning the rights of rightholders with regard to the choice of a collective management organisation. (16) This Directive should allow agreements concluded between a collective management organisation and operators of retransmission services for rights that are subject to mandatory collective management under this Directive to be extended to apply to the rights of rightholders who are not represented by that collective management organisation, without those rightholders being allowed to exclude their works or other subject matter from the application of that mechanism. In cases where there is more than one collective management organisation that manages the rights of the relevant category for its territory, it should be for the Member State, in respect of the territory of which the operator of a retransmission service seeks to clear the rights for a retransmission, to determine which collective management organisation or organisations have the right to grant or refuse the authorisation for a retransmission. (17) Any rights held by broadcasting organisations themselves in respect of their broadcasts, including rights in the content of programmes, should not be subject to the mandatory collective management of rights applicable for retransmissions. Operators of retransmission services and broadcasting organisations generally have ongoing commercial relations, and as a result the identity of broadcasting organisations is known to operators of retransmission services. Accordingly, it is comparatively simple for those operators to clear the rights with broadcasting organisations. As a consequence, to obtain the necessary licences from broadcasting organisations, operators of retransmission services do not face the same burden as they face when seeking to obtain licences from holders of rights in works and other protected subject matter included in the television and radio programmes they retransmit. Therefore, there is no need for simplification of the licensing process with regard to rights held by broadcasting organisations. It is, however, necessary to ensure that where broadcasting organisations and operators of retransmission services enter into negotiations, they negotiate in good faith regarding the licensing of rights for the retransmissions covered by this Directive. Directive 2014/26/EU provides for similar rules applicable to collective management organisations. (18) The rules provided for in this Directive concerning the rights in retransmission exercised by broadcasting organisations in respect of their own transmissions should not limit the choice of rightholders to transfer their rights either to a broadcasting organisation or to a collective management organisation, thereby allowing them to have a direct share in the remuneration paid by the operator of a retransmission service. (19) Member States should be able to apply the rules on retransmission established in this Directive and in Directive 93/83/EEC to situations where both the initial transmission and the retransmission take place within their territory. (20) In order to ensure that there is legal certainty and to maintain a high level of protection for rightholders, it is appropriate to provide that when broadcasting organisations transmit their programme-carrying signals by direct injection only to signal distributors without directly transmitting their programmes to the public, and the signal distributors send those programme-carrying signals to their users to allow them to watch or listen to the programmes, only one single act of communication to the public is deemed to occur in which both the broadcasting organisations and the signal distributors participate with their respective contributions. The broadcasting organisations and the signal distributors should therefore obtain authorisation from the rightholders for their specific contribution to the single act of communication to the public. Participation of a broadcasting organisation and a signal distributor in that single act of communication to the public should not give rise to joint liability on the part of the broadcasting organisation and the signal distributor for that act of communication to the public. Member States should remain free to provide at national level for the arrangements for obtaining authorisation for such a single act of communication to the public, including the relevant payments to be made to the rightholders concerned, taking into account the respective exploitation of the works and other protected subject matter, by the broadcasting organisation and signal distributor, related to the single act of communication to the public. Signal distributors face, in a similar manner to operators of retransmission services, a significant burden for rights clearance, except as regards rights held by broadcasting organisations. Member States should therefore be allowed to provide that signal distributors benefit from a mechanism of mandatory collective management of rights for their transmissions in the same way and to the same extent as operators of retransmission services for retransmissions covered by Directive 93/83/EEC and this Directive. Where signal distributors merely provide broadcasting organisations with \u2018technical means\u2019, within the meaning of the case-law of the Court of Justice of the European Union, to ensure that the broadcast is received or to improve the reception of that broadcast, the signal distributors should not be considered to be participating in an act of communication to the public. (21) When broadcasting organisations transmit their programme-carrying signals directly to the public, thereby carrying out an initial act of transmission, and also simultaneously transmit those signals to other organisations through the technical process of direct injection, for example to ensure the quality of the signals for retransmission purposes, the transmissions by those other organisations constitute a separate act of communication to the public from the one carried out by the broadcasting organisation. In those situations, the rules on retransmissions laid down in this Directive and in Directive 93/83/EEC, as amended by this Directive, should apply. (22) To ensure the efficient collective management of rights and the accurate distribution of revenues collected under the mandatory collective management mechanism introduced by this Directive, it is important that collective management organisations maintain proper records of membership, licences and the use of works and other protected subject matter, in accordance with the transparency obligations set out in Directive 2014/26/EU. (23) In order to prevent circumvention of the application of the country of origin principle through the extension of the duration of existing agreements concerning the exercise of copyright and related rights relevant for the provision of an ancillary online service as well as the access to or the use of that service, it is necessary to apply the country of origin principle also to existing agreements, but with a transitional period. During that transitional period, the principle should not apply to those existing agreements, thus providing time to adapt them, where necessary, in accordance with this Directive. It is also necessary to provide for a transitional period in order to allow broadcasting organisations, signal distributors and rightholders to adapt to the new rules on the exploitation of works and other protected subject matter through direct injection set out in the provisions in this Directive on transmission of programmes through direct injection. (24) In line with the principles of better regulation, a review of this Directive, including its provisions on direct injection, should be undertaken after a certain period of time of this Directive being in force, in order to assess, inter alia, its benefits for Union consumers, its impact on the creative industries in the Union, and on the level of investment in new content, and hence also the benefits regarding improved cultural diversity in the Union. (25) This Directive respects the fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union. While this Directive may result in an interference with the exercise of the rights of rightholders, insofar as mandatory collective management takes place for the exercise of the right of communication to the public with regard to retransmission services, it is necessary to prescribe the application of mandatory collective management in a targeted manner and to limit it to specific services. (26) Since the objectives of this Directive, namely promoting the cross-border provision of ancillary online services for certain types of programmes and facilitating retransmissions of television and radio programmes originating in other Member States, cannot be sufficiently achieved by Member States but can rather, by reason of the scale and effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. As concerns the cross-border provision of ancillary online services, this Directive does not oblige broadcasting organisations to provide such services across borders. Neither does this Directive oblige operators of retransmission services to include in their services television or radio programmes originating in other Member States. This Directive concerns only the exercise of certain retransmission rights to the extent necessary to simplify the licensing of copyright and related rights for such services and with regard to television and radio programmes originating in other Member States. (27) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (8), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I General provisions Article 1 Subject matter This Directive lays down rules that aim to enhance cross-border access to a greater number of television and radio programmes, by facilitating the clearance of rights for the provision of online services that are ancillary to the broadcast of certain types of television and radio programmes, and for the retransmission of television and radio programmes. It also lays down rules for the transmission of television and radio programmes through the process of direct injection. Article 2 Definitions For the purpose of this Directive, the following definitions apply: (1) \u2018ancillary online service\u2019 means an online service consisting in the provision to the public, by or under the control and responsibility of a broadcasting organisation, of television or radio programmes simultaneously with or for a defined period of time after their broadcast by the broadcasting organisation, as well as of any material which is ancillary to such broadcast; (2) \u2018retransmission\u2019 means any simultaneous, unaltered and unabridged retransmission, other than cable retransmission as defined in Directive 93/83/EEC, intended for reception by the public, of an initial transmission from another Member State of television or radio programmes intended for reception by the public, where such initial transmission is by wire or over the air including that by satellite, but is not by online transmission, provided that: (a) the retransmission is carried out by a party other than the broadcasting organisation which made the initial transmission or under whose control and responsibility that initial transmission was made, regardless of how the party carrying out the retransmission obtains the programme-carrying signals from the broadcasting organisation for the purpose of retransmission; and (b) where the retransmission is over an internet access service as defined in point (2) of the second paragraph of Article 2 of Regulation (EU) 2015/2120, it is carried out in a managed environment; (3) \u2018managed environment\u2019 means an environment in which an operator of a retransmission service provides a secure retransmission to authorised users; (4) \u2018direct injection\u2019 means a technical process by which a broadcasting organisation transmits its programme-carrying signals to an organisation other than a broadcasting organisation, in such a way that the programme-carrying signals are not accessible to the public during that transmission. CHAPTER II Ancillary online services of broadcasting organisations Article 3 Application of the country of origin principle to ancillary online services 1. The acts of communication to the public of works or other protected subject matter, by wire or wireless means, and of making available to the public of works or other protected subject matter, by wire or wireless means, in such a way that members of the public may access them from a place and at a time individually chosen by them, occurring when providing to the public: (a) radio programmes; and (b) television programmes which are: (i) news and current affairs programmes; or (ii) fully financed own productions of the broadcasting organisation, in an ancillary online service by or under the control and responsibility of a broadcasting organisation, as well as the acts of reproduction of such works or other protected subject matter which are necessary for the provision of, the access to or the use of such online service for the same programmes shall, for the purposes of exercising copyright and related rights relevant for those acts, be deemed to occur solely in the Member State in which the broadcasting organisation has its principal establishment. Point (b) of the first subparagraph shall not apply to the broadcasts of sports events and works and other protected subject matter included in them. 2. Member States shall ensure that, when setting the amount of the payment to be made for the rights to which the country of origin principle, as set out in paragraph 1, applies, the parties take into account all aspects of the ancillary online service, such as features of the service, including the duration of online availability of the programmes provided in that service, the audience, and the language versions provided. The first subparagraph shall not preclude calculation of the amount of the payment on the basis of the broadcasting organisation's revenues. 3. The country of origin principle set out in paragraph 1 shall be without prejudice to the contractual freedom of the rightholders and broadcasting organisations to agree, in compliance with Union law, to limit the exploitation of such rights, including those under Directive 2001/29/EC. CHAPTER III Retransmission of television and radio programmes Article 4 Exercise of the rights in retransmission by rightholders other than broadcasting organisations 1. Acts of retransmission of programmes have to be authorised by the holders of the exclusive right of communication to the public. Member States shall ensure that rightholders may exercise their right to grant or refuse the authorisation for a retransmission only through a collective management organisation. 2. Where a rightholder has not transferred the management of the right referred to in the second subparagraph of paragraph 1 to a collective management organisation, the collective management organisation which manages rights of the same category for the territory of the Member State for which the operator of a retransmission service seeks to clear rights for a retransmission shall be deemed to have the right to grant or refuse the authorisation for a retransmission for that rightholder. However, where more than one collective management organisation manages rights of that category for the territory of that Member State, it shall be for the Member State for the territory of which the operator of a retransmission service seeks to clear rights for a retransmission to decide which collective management organisation or organisations have the right to grant or refuse the authorisation for a retransmission. 3. Member States shall ensure that a rightholder has the same rights and obligations resulting from an agreement between an operator of a retransmission service and a collective management organisation or organisations that act pursuant to paragraph 2, as rightholders who have mandated that collective management organisation or organisations. Member States shall also ensure that that rightholder is able to claim those rights within a period, to be fixed by the Member State concerned, which shall not be shorter than three years from the date of the retransmission which includes his or her work or other protected subject matter. Article 5 Exercise of the rights in retransmission by broadcasting organisations 1. Member States shall ensure that Article 4 does not apply to the rights in retransmission exercised by a broadcasting organisation in respect of its own transmission, irrespective of whether the rights concerned are its own or have been transferred to it by other rightholders. 2. Member States shall provide that, where broadcasting organisations and the operators of retransmission services enter into negotiations regarding authorisation for retransmission under this Directive, those negotiations are to be conducted in good faith. Article 6 Mediation Member States shall ensure that it is possible to call upon the assistance of one or more mediators as provided for in Article 11 of Directive 93/83/EEC where no agreement is concluded between the collective management organisation and the operator of a retransmission service, or between the operator of a retransmission service and the broadcasting organisation regarding authorisation for retransmission of broadcasts. Article 7 Retransmission of an initial transmission originating in the same Member State Member States may provide that the rules in this Chapter and in Chapter III of Directive 93/83/EEC apply to situations where both the initial transmission and the retransmission take place within their territory. CHAPTER IV Transmission of programmes through direct injection Article 8 Transmission of programmes through direct injection 1. When a broadcasting organisation transmits by direct injection its programme-carrying signals to a signal distributor, without the broadcasting organisation itself simultaneously transmitting those programme-carrying signals directly to the public, and the signal distributor transmits those programme-carrying signals to the public, the broadcasting organisation and the signal distributor shall be deemed to be participating in a single act of communication to the public in respect of which they shall obtain authorisation from rightholders. Member States may provide for arrangements for obtaining authorisation from rightholders. 2. Member States may provide that Articles 4, 5 and 6 of this Directive apply mutatis mutandis to the exercise by rightholders of the right to grant or refuse the authorisation to signal distributors for a transmission referred to in paragraph 1, carried out by one of the technical means referred to in Article 1(3) of Directive 93/83/EEC or point (2) of Article 2 of this Directive. CHAPTER V Final provisions Article 9 Amendment to Directive 93/83/EEC In Article 1 of Directive 93/83/EEC, paragraph 3 is replaced by the following: \u20183. For the purposes of this Directive, \u201ccable retransmission\u201d means the simultaneous, unaltered and unabridged retransmission by a cable or microwave system for reception by the public of an initial transmission from another Member State, by wire or over the air, including that by satellite, of television or radio programmes intended for reception by the public, regardless of how the operator of a cable retransmission service obtains the programme-carrying signals from the broadcasting organisation for the purpose of retransmission.\u2019. Article 10 Review 1. By 7 June 2025, the Commission shall carry out a review of this Directive and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. The report shall be published and made available to the public on the website of the Commission. 2. Member States shall provide the Commission, in a timely manner, with the relevant and necessary information for the preparation of the report referred to in paragraph 1. Article 11 Transitional provision Agreements on the exercise of copyright and related rights relevant for the acts of communication to the public of works or other protected subject matter, by wire or wireless means, and the making available to the public of works or other protected subject matter, by wire or wireless means, in such a way that members of the public may access them from a place and at a time individually chosen by them, occurring in the course of provision of an ancillary online service as well as for the acts of reproduction which are necessary for the provision of, the access to or the use of such online service which are in force on 7 June 2021 shall be subject to Article 3 as from 7 June 2023 if they expire after that date. Authorisations obtained for the acts of communication to the public falling under Article 8 which are in force on 7 June 2021 shall be subject to Article 8 as from 7 June 2025 if they expire after that date. Article 12 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 7 June 2021. They shall immediately inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods for making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the measures of national law which they adopt in the field covered by this Directive. Article 13 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 14 Addressees This Directive is addressed to the Member States. Done at Strasbourg, 17 April 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 125, 21.4.2017, p. 27. (2) Position of the European Parliament of 28 March 2019 (not yet published in the Official Journal) and decision of the Council of 15 April 2019. (3) Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p. 10). (4) Directive 2006/115/EC of the European Parliament and of the Council of 12 December 2006 on rental right and lending right and on certain rights related to copyright in the field of intellectual property (OJ L 376, 27.12.2006, p. 28). (5) Council Directive 93/83/EEC of 27 September 1993 on the coordination of certain rules concerning copyright and rights related to copyright applicable to satellite broadcasting and cable retransmission (OJ L 248, 6.10.1993, p. 15). (6) Regulation (EU) 2015/2120 of the European Parliament and of the Council of 25 November 2015 laying down measures concerning open internet access and amending Directive 2002/22/EC on universal service and users' rights relating to electronic communications networks and services and Regulation (EU) No 531/2012 on roaming on public mobile communications networks within the Union (OJ L 310, 26.11.2015, p. 1). (7) Directive 2014/26/EU of the European Parliament and of the Council of 26 February 2014 on collective management of copyright and related rights and multi-territorial licensing of rights in musical works for online use in the internal market (OJ L 84, 20.3.2014, p. 72). (8) OJ C 369, 17.12.2011, p. 14.", "summary": "Copyright \u2014 broadcasters\u2019 online transmissions and retransmissions of television and radio programmes Copyright \u2014 broadcasters\u2019 online transmissions and retransmissions of television and radio programmes SUMMARY OF: Directive (EU) 2019/789 \u2014 rules on the exercise of copyright and related rights applicable to certain online transmissions of broadcasting organisations and retransmissions of television and radio programmes WHAT IS THE AIM OF THE DIRECTIVE? It aims to improve the cross-border availability of television and radio programmes in the EU\u2019s single market, by making it easier to clear copyright and related rights* for certain online services of broadcasters and for the retransmission* of television and radio programmes by means other than cable. It also contains rules for programmes transmitted via direct injection*. KEY POINTS \u2018Country of origin\u2019 principle* for certain online services provided by broadcasters In addition to traditional forms of broadcasting, broadcasters increasingly offer simultaneous transmissions over the internet (simulcasting) and the possibility to view or listen to a programme online after a defined period of time (catch-up services). The directive provides that, to include certain programmes in their online services available across borders, broadcasters only need to obtain the authorisation of the rights holders of the works and other subject-matter contained in those programmes for the EU country where they have their principal establishment. This \u2018country of origin\u2019 principle (already used for satellite broadcasting in Directive 93/83/EEC) applies to all radio programmes and to certain types of television programmes: news and current affairs programmes (except sports events and protected subject-matter included in them); andprogrammes that are produced and fully financed by a broadcaster itself. Existing contracts remain unaffected for 4 years from the entry into force of the directive (until 7 June 2023). Mandatory collective management of rights for retransmission of radio and television programmes by means other than cable The directive also makes it easier to obtain the authorisation of holders of copyright and related rights for the retransmission of television or radio programmes from other EU countries. Rights holders can exercise their right to authorise or deny authorisation for such retransmissions only via a collective management organisation*, except for the rights that are already held by the concerned broadcasters. This applies to the simultaneous, unaltered and unabridged retransmission via any means other than cable, including the open internet (but only when the retransmission over the open internet takes place in a secure environment and to a group of authorised users). Retransmissions by cable are covered by Directive 93/83/EEC. EU countries must ensure that mediation is available to assist the parties in the conclusion of licences for retransmission services. EU countries are also explicitly allowed to apply the rules described above when transmissions and retransmissions take place within their territory. Direct injection The directive lays down rules that regulate the use of protected works or other subject-matter via \u2018direct injection\u2019, i.e. the technique by which a broadcaster transmits its signal to distributors via a private line - in a way that those signals cannot be received by the general public during that transmission - and, subsequently, the distributor offers the relevant programmes to the public. When direct injection is used, and there is no parallel transmission of the same programmes by the broadcaster itself, the broadcasting organisation and the signal distributor are deemed to be participating in a single act of communication to the public. This means that both parties need to obtain authorisation for their respective participation in that activity. Existing contracts remain unaffected for 6 years from the entry into force of the directive (until 7 June 2025). FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 6 June 2019 and has to become law in the EU countries by 7 June 2021. BACKGROUND See also: Modernisation of the EU copyright rules (European Commission) EU set to enhance cross-border access to online content \u2014 press release (Council of the European Union). KEY TERMS Related rights: rights granted to performers, producers and broadcasters (as opposed to copyright or authors\u2019 rights) which enable rightholders to control the use of their works and other protected material and be remunerated for their use. Retransmission: in the context of Directive (EU) 2019/789, the licensing of rights when radio and television programmes are retransmitted by other radio and TV channels but also over the internet (parallel transmissions/simulcasting or catch-up services when consumers can view/listen to programmes at a time that is later than the original broadcast). Direct injection: a technical process by which a broadcaster transmits programme-carrying signals to a distributor, in such a way that the signals are not accessible to the public during the transmission. Country of origin principle: broadcasters only need to clear copyright in their EU country of establishment (i.e. the country of origin) in order to make radio programmes, TV news and current affairs as well as their fully financed own productions available online in all EU countries. Collective management organisations: organisations which collect, manage and distribute earnings from the exploitation of the rights the responsibility for which rightsholders have delegated to them. MAIN DOCUMENT Directive (EU) 2019/789 of the European Parliament and of the Council of 17 April 2019 laying down rules on the exercise of copyright and related rights applicable to certain online transmissions of broadcasting organisations and retransmissions of television and radio programmes, and amending Council Directive 93/83/EEC (OJ L 130, 17.5.2019, pp. 82-91) RELATED DOCUMENTS Council Directive 93/83/EEC of 27 September 1993 on the coordination of certain rules concerning copyright and rights related to copyright applicable to satellite broadcasting and cable retransmission (OJ L 248, 6.10.1993, pp. 15-21) Successive amendments to Directive 93/83/EEC have been incorporated into the original text. This consolidated version is of documentary value only. last update 21.10.2019"}
{"article": "29.3.2019 EN Official Journal of the European Union L 91/1 REGULATION (EU) 2019/515 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The internal market comprises an area without internal frontiers in which the free movement of goods is ensured in accordance with the Treaties. Quantitative restrictions on imports and all measures having equivalent effect are prohibited between Member States. That prohibition covers any national measure which is capable of hindering, directly or indirectly, actually or potentially, intra-Union trade in goods. The free movement of goods is ensured in the internal market by the harmonisation of rules at Union level that set common requirements for the marketing of certain goods or, for goods or aspects of goods not exhaustively covered by Union harmonisation rules, by the application of the principle of mutual recognition as defined by the Court of Justice of the European Union. (2) A well-functioning principle of mutual recognition is an essential complement to harmonisation of rules at Union level, especially considering that many goods have both harmonised and non-harmonised aspects. (3) Obstacles to the free movement of goods between Member States may be unlawfully created if, in the absence of Union harmonisation rules covering goods or certain aspects of goods, a Member State's competent authority applies national rules to goods that are lawfully marketed in another Member State, requiring the goods to meet certain technical requirements, for example, requirements relating to designation, form, size, weight, composition, presentation, labelling or packaging. The application of such rules to goods that are lawfully marketed in another Member State could be contrary to Articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU), even if the rules apply to all goods without distinction. (4) The principle of mutual recognition derives from the case-law of the Court of Justice of the European Union. According to this principle, Member States may not prohibit the sale on their territory of goods which are lawfully marketed in another Member State, even where those goods have been produced in accordance with different technical rules, including goods that are not the result of a manufacturing process. But the principle of mutual recognition is not absolute. Member States can restrict the marketing of goods that have been lawfully marketed in another Member State, where such restrictions are justified on the grounds set out in Article 36 TFEU or on the basis of other overriding reasons of public interest, recognised by the case-law of the Court of Justice of the European Union in relation to the free movement of goods, and where those restrictions are proportionate to the aim pursued. This Regulation imposes the obligation to clearly justify why market access has been restricted or denied. (5) The concept of overriding reasons of public interest is an evolving concept developed by the Court of Justice of the European Union in its case-law in relation to Articles 34 and 36 TFEU. Where legitimate differences exist from one Member State to another, such overriding reasons might justify the application of national technical rules by the competent authorities. However, administrative decisions always need to be duly justified, to be legitimate, to be appropriate and to respect the principle of proportionality, and the competent authority has to make the least restrictive decision possible. In order to improve the functioning of the internal market for goods, the national technical rules should be fit for purpose and should not create disproportionate non-tariff barriers. Furthermore, administrative decisions restricting or denying market access in respect of goods that are lawfully marketed in another Member State must not be based on the mere fact that the goods under assessment fulfil the legitimate public objective pursued by the Member State in a different way from the way in which goods in that Member State fulfil that objective. In order to assist Member States, the Commission should provide non-binding guidance in relation to the case-law of the Court of Justice of the European Union on the concept of overriding reasons of public interest and how to apply the principle of mutual recognition. Competent authorities should have the opportunity to provide contributions and deliver feedback on the guidance. (6) In its Conclusions on the Single Market Policy of December 2013, the Competitiveness Council noted that to improve framework conditions for businesses and consumers in the Single Market, all relevant instruments should be appropriately employed, including mutual recognition. The Council invited the Commission to report on cases where the functioning of the principle of mutual recognition is still inadequate or problematic. In its Conclusions on the Single Market Policy of February 2015, the Competitiveness Council urged the Commission to take steps to ensure that the principle of mutual recognition functioned effectively and to bring forward proposals to that effect. (7) Regulation (EC) No 764/2008 of the European Parliament and of the Council (3) was adopted in order to facilitate the application of the principle of mutual recognition by establishing procedures to minimise the possibility of creating unlawful obstacles to the free movement of goods which have already been lawfully marketed in another Member State. Despite the adoption of that Regulation, many problems still exist as regards the application of the principle of mutual recognition. The evaluation carried out between 2014 and 2016 showed that the principle of mutual recognition does not function as it should, and that Regulation (EC) No 764/2008 has had limited effect in facilitating the application of that principle. The tools and procedural guarantees put in place by that Regulation failed in their aim of improving the application of the principle of mutual recognition. For example, the Product Contact Points network which was put in place in order to provide information to economic operators on applicable national rules and the application of the principle of mutual recognition is barely known or used by economic operators. Within that network, national authorities do not cooperate sufficiently. The requirement to notify administrative decisions restricting or denying market access is rarely complied with. As a result, obstacles to the free movement of goods in the internal market remain. (8) Regulation (EC) No 764/2008 has several shortcomings, and should therefore be revised and strengthened. For the sake of clarity, Regulation (EC) No 764/2008 should be replaced by this Regulation. This Regulation should establish clear procedures to ensure the free movement of goods lawfully marketed in another Member State and to ensure that free movement can be restricted only where Member States have legitimate public interest grounds for doing so and that the restriction is justified and proportionate. This Regulation should also ensure that existing rights and obligations deriving from the principle of mutual recognition are observed, by both economic operators and national authorities. (9) This Regulation should not prejudice the further harmonisation of conditions for the marketing of goods with a view to improving the functioning of the internal market, where appropriate. (10) It is also possible for trade barriers to result from other types of measures falling under the scope of Articles 34 and 36 TFEU. Those measures can include, for example, technical specifications drawn up for public procurement procedures or requirements to use official languages in the Member States. However, such measures should not constitute national technical rules within the meaning of this Regulation and should not fall within its scope. (11) National technical rules are sometimes given effect in a Member State by means of a prior authorisation procedure, under which formal approval has to be obtained from a competent authority before the goods can be placed on the market there. The existence of a prior authorisation procedure in itself restricts the free movement of goods. Therefore, in order to be justified with regard to the fundamental principle of the free movement of goods within the internal market, such a procedure has to pursue a public interest objective recognised by Union law, and it has to be proportionate and non-discriminatory. The compliance of such a procedure with Union law is to be assessed in the light of the considerations set out in the case-law of the Court of Justice of the European Union. Therefore, administrative decisions restricting or denying market access exclusively on the grounds that the goods do not have a valid prior authorisation should be excluded from the scope of this Regulation. When, however, an application for mandatory prior authorisation of goods is made, any administrative decision to reject the application on the basis of a national technical rule applicable in that Member State should only be taken in accordance with this Regulation, so that the applicant can benefit from the procedural protection which this Regulation provides. The same applies to voluntary prior authorisation of goods, where it exists. (12) It is important to clarify that the types of goods covered by this Regulation include agricultural products. The term \u2018agricultural products\u2019 includes products of fisheries, as provided for in Article 38(1) TFEU. In order to help to identify which types of goods are subject to this Regulation, the Commission should assess the feasibility and benefits of further developing an indicative product list for mutual recognition. (13) It is also important to clarify that the term \u2018producer\u2019 includes not only manufacturers of goods, but also persons who produce goods which were not the result of a manufacturing process, including agricultural products, as well as persons who present themselves as the producers of goods. (14) Decisions of national courts or tribunals assessing the legality of cases in which, on account of the application of a national technical rule, goods lawfully marketed in one Member State are not granted access to the market in another Member State, and decisions of national courts or tribunals applying penalties, should be excluded from the scope of this Regulation. (15) To benefit from the principle of mutual recognition, goods must be lawfully marketed in another Member State. It should be clarified that, for goods to be considered to be lawfully marketed in another Member State, the goods need to comply with the relevant rules applicable in that Member State, and need to be made available to end users in that Member State. (16) To raise awareness on the part of national authorities and economic operators of the principle of mutual recognition, Member States should consider providing for clear and unambiguous \u2018single market clauses\u2019 in their national technical rules with a view to facilitating the application of that principle. (17) The evidence required to demonstrate that goods are lawfully marketed in another Member State varies significantly from Member State to Member State. This causes unnecessary burdens, delays and additional costs for economic operators, and prevents national authorities from obtaining the information necessary for assessing the goods in a timely manner. This may inhibit the application of the principle of mutual recognition. It is therefore essential to make it easier for economic operators to demonstrate that their goods are lawfully marketed in another Member State. Economic operators should benefit from a self-declaration that provides competent authorities with all necessary information on the goods and on their compliance with the rules applicable in that other Member State. The use of voluntary declarations should not prevent national authorities from taking administrative decisions restricting or denying market access, provided that such decisions are proportionate, justified and respect the principle of mutual recognition and are in accordance with this Regulation. (18) It should be possible for the producer, importer or distributor to draw up a declaration of lawful marketing of goods for the purposes of mutual recognition (\u2018mutual recognition declaration\u2019). The producer is best placed to provide the information in the mutual recognition declaration as the producer knows the goods best and is in possession of the evidence necessary to verify the information in the mutual recognition declaration. The producer should be able to mandate an authorised representative to draw up such declarations on the producer's behalf and under the responsibility of the producer. However, where an economic operator is only able to provide the information on the lawfulness of the marketing of the goods in the declaration, it should be possible for another economic operator to provide the information that the goods are being made available to end users in the Member State concerned, provided that that economic operator takes responsibility for the information that it provided in the mutual recognition declaration and is able to provide the necessary evidence to verify this information. (19) The mutual recognition declaration should always contain accurate and complete information on the goods. The declaration should therefore be kept up to date in order to reflect changes, for example changes in the relevant national technical rules. (20) In order to ensure that the information provided in a mutual recognition declaration is comprehensive, a harmonised structure for such declarations should be laid down for use by economic operators wishing to make such declarations. (21) It is important to ensure that the mutual recognition declaration is filled in truthfully and accurately. It is therefore necessary to require economic operators to be responsible for the information provided by them in the mutual recognition declaration. (22) In order to enhance the efficiency and competitiveness of businesses operating in the field of goods that are not covered by Union harmonisation legislation, it should be possible to benefit from new information technologies for the purpose of facilitating the provision of the mutual recognition declaration. Therefore, economic operators should be able to make their mutual recognition declarations publicly available online, provided that the mutual recognition declaration is easily accessible and is in a reliable format. (23) The Commission should ensure that a template for the mutual recognition declaration and guidelines for completing it are made available on the Single Digital Gateway in all of the official languages of the Union. (24) This Regulation should also apply to goods in respect of which only some aspects are covered by Union harmonisation legislation. Where, pursuant to Union harmonisation legislation, the economic operator is required to draw up an EU declaration of conformity to demonstrate compliance with that legislation, that economic operator should be permitted to attach the mutual recognition declaration provided for by this Regulation to the EU declaration of conformity. (25) Where economic operators decide not to use the mutual recognition declaration, it should be for the competent authorities of the Member State of destination to make clearly defined requests for specific information that they consider to be necessary to assess the goods, with respect to the principle of proportionality. (26) The economic operator should be given appropriate time within which to submit documents or any other information requested by the competent authority of the Member State of destination, or to submit any arguments or comments in relation to the assessment of the goods in question. (27) Directive (EU) 2015/1535 of the European Parliament and of the Council (4) requires Member States to communicate to the Commission and to the other Member States any draft national technical regulation concerning any product, including any agricultural or fishery product, and a statement of the grounds on which the enactment of that regulation is necessary. It is necessary, however, to ensure that, following the adoption of such a national technical regulation, the principle of mutual recognition is correctly applied to specific goods in individual cases. This Regulation should lay down procedures for the application of the principle of mutual recognition in individual cases, for example, by requiring Member States to indicate the national technical rules on which the administrative decision is based and the legitimate public interest grounds that justify the application of that national technical rule with respect to a good that has been lawfully marketed in another Member State. The proportionality of the national technical rule is the basis for demonstrating the proportionality of the administrative decision that is based on that rule. However, the means by which the proportionality of the administrative decision is to be demonstrated should be determined on a case-by-case basis. (28) As administrative decisions restricting or denying market access for goods that are already lawfully marketed in another Member State should be exceptions to the fundamental principle of the free movement of goods, it is necessary to ensure that such decisions observe the existing obligations that derive from the principle of mutual recognition. It is therefore appropriate to establish a clear procedure for determining whether goods are lawfully marketed in that other Member State and, if so, whether the legitimate public interests covered by the applicable national technical rule of the Member State of destination are adequately protected, in accordance with Article 36 TFEU and the case-law of the Court of Justice of the European Union. Such procedure should ensure that any administrative decisions that are taken are proportionate and respect the principle of mutual recognition and are in accordance with this Regulation. (29) Where a competent authority is assessing goods before deciding whether to restrict or deny market access, that authority should not be able to take decisions to suspend market access, except where rapid intervention is required to prevent harm to the safety or health of persons, to prevent harm to the environment, or to prevent the goods from being made available in cases where the making available of such goods is generally prohibited on grounds of public morality or public security, including, for example, the prevention of crime. (30) Regulation (EC) No 765/2008 of the European Parliament and of the Council (5) establishes a system of accreditation which ensures the mutual acceptance of the level of competence of conformity assessment bodies. The competent authorities of Member States should therefore not refuse to accept test reports and certificates issued by an accredited conformity assessment body on grounds related to the competence of that body. Furthermore, in order to avoid as far as possible the duplication of tests and procedures which have been already carried out in another Member State, Member States should not refuse to accept test reports and certificates issued by other conformity assessment bodies in accordance with Union law. Competent authorities should take due account of the content of the test reports or certificates submitted. (31) Directive 2001/95/EC of the European Parliament and of the Council (6) specifies that only safe products may be placed on the market and lays down the obligations of producers and distributors with respect to the safety of products. It entitles the competent authorities to ban any dangerous product with immediate effect or to ban products that could be dangerous temporarily for the period needed for the various safety evaluations, checks and controls. That Directive also describes the procedure for competent authorities to apply appropriate measures if products pose a risk, such as the measures referred to in points (b) to (f) of Article 8(1) of that Directive, and it also imposes an obligation on Member States to notify such measures to the Commission and the other Member States. Therefore, competent authorities should be able to continue applying that Directive and, in particular, points (b) to (f) of Article 8(1) and Article 8(3) of that Directive. (32) Regulation (EC) No 178/2002 of the European Parliament and of the Council (7) establishes, inter alia, a rapid alert system for the notification of direct or indirect risks to human health deriving from food or feed. It requires Member States to notify the Commission immediately, using the rapid alert system, of any measure they adopt which is aimed at restricting the placing on the market of food or feed, or withdrawing or recalling food or feed, for the purpose of protecting human health, and which requires rapid action. Competent authorities should be able to continue applying that Regulation and, in particular, Articles 50(3) and 54 of that Regulation. (33) Regulation (EU) 2017/625 of European Parliament and of the Council (8) establishes a harmonised Union framework for the organisation of official controls, and for the organisation of official activities other than official controls, along the entire agri-food chain, taking into account the rules on official controls laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council (9) and in relevant Union sectoral legislation. Regulation (EU) 2017/625 lays down a specific procedure for ensuring that economic operators remedy situations of non-compliance with food and feed law, animal health rules or animal welfare rules. Competent authorities should be able to continue applying Regulation (EU) 2017/625 and, in particular, Article 138 thereof. (34) Regulation (EU) No 1306/2013 of the European Parliament and of the Council (10) establishes a harmonised Union framework for carrying out checks in respect of the obligations laid down in Regulation (EU) No 1308/2013 of the European Parliament and of the Council (11) in accordance with the criteria laid down in Regulation (EC) No 882/2004 and specifies that Member States shall ensure that any operator complying with those obligations is entitled to be covered by a system of checks. Competent authorities should be able to continue applying Regulation (EU) No 1306/2013 and, in particular, Article 90 thereof. (35) Any administrative decision taken by competent authorities of Member States pursuant to this Regulation should specify the remedies available to the economic operator, so that an economic operator is able, in accordance with national law, to appeal against the decision or bring proceedings before the competent national court or tribunal. The administrative decision should also refer to the possibility for economic operators to use the Internal Market Problem Solving Network (SOLVIT) and the problem-solving procedure provided for in this Regulation. (36) Effective solutions for economic operators wishing for a business friendly alternative when challenging administrative decisions restricting or denying market access are essential to ensure the correct and consistent application of the principle of mutual recognition. In order to guarantee such solutions, and to avoid legal costs, especially for small and medium-sized enterprises (SMEs), a non-judicial problem-solving procedure should be available for economic operators. (37) SOLVIT is a service provided by the national administration in each Member State that aims to find solutions for individuals and businesses when their rights have been breached by public authorities in another Member State. The principles governing the functioning of SOLVIT are set out in Commission Recommendation 2013/461/EU (12), according to which each Member State is to provide for a SOLVIT Centre that has adequate human and financial resources to ensure that the SOLVIT Centre takes part in SOLVIT. The Commission should increase awareness about the existence and benefits of SOLVIT, especially among businesses. (38) SOLVIT is an effective non-judicial, problem-solving mechanism that is provided free of charge. It works under short deadlines and provides practical solutions to individuals and businesses when they are experiencing difficulties in the recognition of their Union rights by public authorities. Where the economic operator, the relevant SOLVIT Centre and the Member States involved all agree on the appropriate outcome, no further action should be required. (39) However, where the SOLVIT's informal approach fails, and doubts remain regarding the compatibility of the administrative decision with the principle of mutual recognition, the Commission should be empowered to look into the matter at the request of any of the SOLVIT Centres involved. Following its assessment, the Commission should issue an opinion to be communicated through the relevant SOLVIT Centre to the economic operator concerned and to the competent authorities, which should be taken into account during the SOLVIT procedure. The Commission's intervention should be subject to a time-limit of 45 working days, which should not include the time necessary for the Commission to receive any additional information and documents that it considers necessary. If the case is solved during this period, the Commission should not be required to issue an opinion. Such SOLVIT cases should be subject to a separate workflow in the SOLVIT database and should not be included in the regular SOLVIT statistics. (40) The opinion of the Commission as regards an administrative decision restricting or denying market access should only address whether the administrative decision is compatible with the principle of mutual recognition and with the requirements of this Regulation. This is without prejudice to the Commission's powers under Article 258 TFEU and the Member States' obligation to comply with Union law, when addressing systemic problems identified as regards the application of the principle of mutual recognition. (41) It is important for the internal market for goods that businesses, in particular SMEs, can obtain reliable and specific information about the law in force in a given Member State. Product Contact Points should play an important role in facilitating communication between national authorities and economic operators by disseminating information about specific product rules and about how the principle of mutual recognition is applied in the territory of their Member State. Therefore, it is necessary to enhance the role of Product Contact Points as the principal providers of information on all product-related rules, including national technical rules covered by mutual recognition. (42) In order to facilitate the free movement of goods, Product Contact Points should provide, free of charge, a reasonable level of information on their national technical rules and the application of the principle of mutual recognition. Product Contact Points should be adequately equipped and resourced. In accordance with Regulation (EU) 2018/1724 of the European Parliament and of the Council (13) they should provide such information through a website and should be subject to the quality criteria set out in that Regulation. The tasks of Product Contact Points related to the provision of any such information, including electronic copies of, or online access to, the national technical rules, should be performed without prejudice to the national rules governing the distribution of national technical rules. Furthermore, Product Contact Points should not be required to provide copies of, or online access to, standards which are subject to the intellectual property rights of standardisation bodies or organisations. (43) Cooperation between competent authorities is essential for the smooth functioning of the principle of mutual recognition and for creating a mutual recognition culture. Product Contact Points and national competent authorities should therefore cooperate and exchange information and expertise in order to ensure the correct and consistent application of the principle of mutual recognition and this Regulation. (44) For the purposes of notifying administrative decisions restricting or denying market access, allowing communication between Product Contact Points and ensuring administrative cooperation, it is necessary to provide Member States with access to an information and communication system. (45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (14). (46) Where, for the purposes of this Regulation, it is necessary to process personal data, such processing should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data under this Regulation is subject to Regulation (EU) 2016/679 of the European Parliament and of the Council (15) or Regulation (EU) 2018/1725 of the European Parliament and of the Council (16). (47) Reliable and efficient monitoring mechanisms should be established to provide information on the application of this Regulation and on its impact on the free movement of goods. Such mechanisms should not go beyond what is necessary to achieve these objectives. (48) For the purposes of raising awareness about the principle of mutual recognition and ensuring that this Regulation is applied correctly and consistently, provision should be made for Union financing of awareness-raising campaigns, trainings, exchange of officials and other related activities aiming at enhancing and supporting trust and cooperation between competent authorities, Product Contact Points and economic operators. (49) In order to remedy the lack of accurate data related to the functioning of the principle of mutual recognition and its impact on the Single Market for goods, the Union should finance the collection of such data. (50) The financial interests of the Union should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties. (51) It is appropriate to defer the application of this Regulation in order to allow competent authorities and economic operators sufficient time to adapt to the requirements laid down herein. (52) The Commission should carry out an evaluation of this Regulation in light of the objectives that it pursues. The Commission should use the data collected on the functioning of the principle of mutual recognition and its impact on the single market for goods and information available in the information and communication system to evaluate this Regulation. The Commission should be able to request Member States to provide additional information necessary for its evaluation. Pursuant to point 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law Making (17), the evaluation of this Regulation, which should be based on efficiency, effectiveness, relevance, coherence and added value, should provide the basis for impact assessments of options for further action. (53) Since the objective of this Regulation, namely to ensure the smooth, consistent and correct application of the principle of mutual recognition, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter 1. The aim of this Regulation is to strengthen the functioning of the internal market by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade. 2. This Regulation lays down rules and procedures concerning the application by Member States of the principle of mutual recognition in individual cases in relation to goods which are subject to Article 34 TFEU and which are lawfully marketed in another Member State, having regard to Article 36 TFEU and the case-law of the Court of Justice of the European Union. 3. This Regulation also provides for the establishment and maintenance of Product Contact Points in Member States and for cooperation and exchange of information in the context of the principle of mutual recognition. Article 2 Scope 1. This Regulation applies to goods of any type, including agricultural products within the meaning of the second subparagraph of Article 38(1) TFEU, and to administrative decisions that have been taken or are to be taken by a competent authority of a Member State of destination in relation to any such goods that are lawfully marketed in another Member State, where the administrative decision meets the following criteria: (a) the basis for the administrative decision is a national technical rule applicable in the Member State of destination; and (b) the direct or indirect effect of the administrative decision is to restrict or deny market access in the Member State of destination. Administrative decision includes any administrative step that is based on a national technical rule and that has the same or substantially the same legal effect as the effect referred to in point (b). 2. For the purposes of this Regulation, a \u2018national technical rule\u2019 is any provision of a law, regulation or other administrative provision of a Member State which has the following characteristics: (a) it covers goods or aspects of goods that are not the subject of harmonisation at Union level; (b) it either prohibits the making available of goods, or goods of a given type, on the market in that Member State, or it makes compliance with the provision compulsory, de facto or de jure, whenever goods, or goods of a given type, are made available on that market; and (c) it does at least one of the following: (i) it lays down the characteristics required of goods or of goods of a given type, such as their levels of quality, performance or safety, or their dimensions, including the requirements applicable to those goods as regards the names under which they are sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; (ii) for the purpose of protecting consumers or the environment, it imposes other requirements on goods or goods of a given type that affect the life-cycle of the goods after they have been made available on the market in that Member State, such as conditions of use, recycling, reuse or disposal, where such conditions can significantly influence either the composition or nature of those goods, or the making available of them on the market in that Member State. 3. Point (c)(i) of paragraph 2 of this Article also covers production methods and processes used in respect of agricultural products as referred to in the second subparagraph of Article 38(1) TFEU, and in respect of products intended for human or animal consumption, as well as production methods and processes relating to other products, where these have an effect on their characteristics. 4. A prior authorisation procedure does not itself constitute a national technical rule for the purposes of this Regulation, but a decision to refuse prior authorisation based on a national technical rule shall be considered to be an administrative decision to which this Regulation applies, if that decision fulfils the other requirements of the first subparagraph of paragraph 1. 5. This Regulation does not apply to: (a) decisions of a judicial nature taken by national courts or tribunals; (b) decisions of a judicial nature taken by law enforcement authorities in the course of the investigation or prosecution of a criminal offence as regards the terminology, symbols or any material reference to unconstitutional or criminal organisations or offences of a racist, discriminatory or xenophobic nature. 6. Articles 5 and 6 shall not affect the application of the following provisions: (a) points (b) to (f) of Article 8(1) and Article 8(3) of Directive 2001/95/EC; (b) point (a) of Article 50(3) and Article 54 of Regulation (EC) No 178/2002; (c) Article 90 of Regulation (EU) No 1306/2013; and (d) Article 138 of Regulation (EU) 2017/625. 7. This Regulation does not affect the obligation under Directive (EU) 2015/1535 to notify draft national technical regulations to the Commission and the Member States prior to their adoption. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018lawfully marketed in another Member State\u2019 means that goods or goods of that type comply with the relevant rules applicable in that Member State or are not subject to any such rules in that Member State, and are made available to end users in that Member State; (2) \u2018making available on the market\u2019 means any supply of goods for distribution, consumption or use on the market within the territory of a Member State in the course of a commercial activity, whether in return for payment or free of charge; (3) \u2018restricting market access\u2019 means imposing conditions to be fulfilled before goods can be made available on the market in the Member State of destination, or conditions for keeping goods on that market, which in either case require the modification of one or more of the characteristics of those goods, as referred to in point (c)(i) of Article 2(2), or require the performance of additional testing; (4) \u2018denying market access\u2019 means any of the following: (a) prohibiting goods from being made available on the market in the Member State of destination or from being kept on that market; or (b) requiring the withdrawal or recall of those goods from that market; (5) \u2018withdrawal\u2019 means any measure aimed at preventing goods in the supply chain from being made available on the market; (6) \u2018recall\u2019 means any measure aimed at achieving the return of goods that have already been made available to the end user; (7) \u2018prior authorisation procedure\u2019 means an administrative procedure under the law of a Member State whereby the competent authority of that Member State is required, on the basis of an application by an economic operator, to give its formal approval before goods may be made available on the market in that Member State; (8) \u2018producer\u2019 means: (a) any natural or legal person who manufactures goods or has goods designed or manufactured, or who produces goods which were not the result of a manufacturing process, including agricultural products, and markets them under that person's name or trademark, (b) any natural or legal person who modifies goods already lawfully marketed in a Member State in a way that might affect compliance with the relevant rules applicable in that Member State, or (c) any other natural or legal person who, by putting its name, trademark or other distinguishing feature on goods or on the documents that accompany those goods, presents itself as the producer of those goods; (9) \u2018authorised representative\u2019 means any natural or legal person established within the Union who has received a written mandate from a producer to act on that producer's behalf with regard to the making available of goods on the market in question; (10) \u2018importer\u2019 means any natural or legal person established within the Union who makes goods from a third country available on the Union market for the first time; (11) \u2018distributor\u2019 means any natural or legal person in the supply chain, other than the producer or the importer, who makes goods available on the market in a Member State; (12) \u2018economic operator\u2019 means any of the following in relation to goods: the producer, the authorised representative, the importer or the distributor; (13) \u2018end user\u2019 means any natural or legal person residing or established in the Union, to whom the goods have been made available or are being made available, either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities; (14) \u2018legitimate public interest grounds\u2019 means any of the grounds set out in Article 36 TFEU or any other overriding reasons of public interest; (15) \u2018conformity assessment body\u2019 means a conformity assessment body as defined in point 13 of Article 2 of Regulation (EC) No 765/2008. CHAPTER II PROCEDURES CONCERNING APPLICATION OF THE PRINCIPLE OF MUTUAL RECOGNITION IN INDIVIDUAL CASES Article 4 Mutual recognition declaration 1. The producer of goods, or of goods of a given type, that are being made or are to be made available on the market in the Member State of destination may draw up a voluntary declaration of lawful marketing of goods for the purposes of mutual recognition (\u2018mutual recognition declaration\u2019) in order to demonstrate to the competent authorities of the Member State of destination that the goods, or the goods of that type, are lawfully marketed in another Member State. The producer may mandate its authorised representative to draw up the mutual recognition declaration on its behalf. The mutual recognition declaration shall follow the structure set out in Part I and Part II of the Annex and shall contain all the information specified therein. The producer or its authorised representative, where mandated to do so, may fill in the mutual recognition declaration with only the information set out in Part I of the Annex. In such case the information set out in Part II of the Annex shall be filled in by the importer or by the distributor. Alternatively, both parts of the mutual recognition declaration may be drawn up by the importer or by the distributor, provided that the signatory can supply the evidence referred to in point (a) of Article 5(4). The mutual recognition declaration shall be drawn up in one of the official languages of the Union. Where that language is not the language required by the Member State of destination, the economic operator shall translate the mutual recognition declaration into a language required by the Member State of destination. 2. Economic operators who sign the mutual recognition declaration or a part of it shall be responsible for the content and accuracy of the information that they provide in the mutual recognition declaration, including the correctness of the information they translate. For the purposes of this paragraph, economic operators shall be liable in accordance with national laws. 3. Economic operators shall ensure that the mutual recognition declaration is kept up to date at all times, reflecting any changes in the information that they have provided in the mutual recognition declaration. 4. The mutual recognition declaration may be supplied to the competent authority of the Member State of destination for the purposes of an assessment to be carried out under Article 5. It may be supplied either in paper form or by electronic means or be made available online in accordance with the requirements of the Member State of destination. 5. Where economic operators make the mutual recognition declaration available online, the following conditions apply: (a) the type of goods or the series to which the mutual recognition declaration applies shall be easily identifiable; and (b) the technical means used shall ensure easy navigation and shall be monitored to ensure the availability of, and access to, the mutual recognition declaration. 6. Where the goods for which the mutual recognition declaration is being supplied are also subject to a Union act requiring an EU declaration of conformity, the mutual recognition declaration may be attached to the EU declaration of conformity. Article 5 Assessment of goods 1. Where a competent authority of the Member State of destination intends to assess goods subject to this Regulation to establish whether the goods or goods of that type are lawfully marketed in another Member State, and, if so, whether the legitimate public interests covered by the applicable national technical rule of the Member State of destination are adequately protected, having regard to the characteristics of the goods in question, it shall contact the economic operator concerned without delay. 2. When entering into contact with the economic operator concerned, the competent authority of the Member State of destination shall inform the economic operator of the assessment, indicating the goods that are subject to that assessment and specifying the applicable national technical rule or prior authorisation procedure. The competent authority of the Member State of destination shall also inform the economic operator of the possibility of supplying a mutual recognition declaration in accordance with Article 4 for the purposes of that assessment. 3. The economic operator shall be allowed to make the goods available on the market in the Member State of destination while the competent authority carries out the assessment under paragraph 1 of this Article, and may continue to do so unless the economic operator receives an administrative decision restricting or denying market access for those goods. This paragraph shall not apply where the assessment is carried out in the framework of a prior authorisation procedure, or where the competent authority temporary suspends the making available on the market of the goods that are subject to that assessment in accordance with Article 6. 4. If a mutual recognition declaration is supplied to a competent authority of the Member State of destination in accordance with Article 4, then for the purposes of the assessment under paragraph 1 of this Article: (a) the mutual recognition declaration, together with supporting evidence necessary to verify the information contained in it that was provided in response to a request by the competent authority, shall be accepted by the competent authority as sufficient to demonstrate that the goods are lawfully marketed in another Member State; and (b) the competent authority shall not require any other information or documentation from any economic operator for the purpose of demonstrating that the goods are lawfully marketed in another Member State. 5. If a mutual recognition declaration is not supplied to a competent authority of the Member State of destination in accordance with Article 4, then for the purposes of the assessment under paragraph 1 of this Article, the competent authority may request the economic operators concerned to provide documentation and information that is necessary for that assessment concerning the following: (a) the characteristics of the goods or type of goods in question; and (b) lawful marketing of the goods in another Member State. 6. The economic operator concerned shall be allowed at least 15 working days following the request of the competent authority of the Member State of destination in which to submit the documents and information referred to in point (a) of paragraph 4 or in paragraph 5, or to submit any arguments or comments that the economic operator might have. 7. For the purposes of the assessment under paragraph 1 of this Article, the competent authority of the Member State of destination, in accordance with Article 10(3), may contact the competent authorities or the Product Contact Points of the Member State in which an economic operator claims to be lawfully marketing its goods, if the competent authority needs to verify any information provided by the economic operator. 8. In carrying out the assessment under paragraph 1, the competent authorities of Member States of destination shall take due account of the content of test reports or certificates issued by a conformity assessment body that have been provided by any economic operator as part of the assessment. The competent authorities of Member States of destination shall not refuse test reports or certificates that were issued by a conformity assessment body accredited for the appropriate field of conformity assessment activity in accordance with Regulation (EC) No 765/2008 on grounds related to the competence of that body. 9. Where, on completion of an assessment under paragraph 1 of this Article, the competent authority of a Member State of destination takes an administrative decision with respect to the goods that it has assessed, it shall notify that administrative decision without delay to the economic operator referred to in paragraph 1 of this Article. The competent authority shall also notify that administrative decision to the Commission and to the other Member States no later than 20 working days after it took the decision. For that purpose, it shall use the system referred to in Article 11. 10. The administrative decision referred to in paragraph 9 shall set out the reasons for the decision in a manner that is sufficiently detailed and reasoned to facilitate an assessment of its compatibility with the principle of mutual recognition and with the requirements of this Regulation. 11. In particular, the following information shall be included in the administrative decision referred to in paragraph 9: (a) the national technical rule on which the administrative decision is based; (b) the legitimate public interest grounds justifying the application of the national technical rule on which the administrative decision is based; (c) the technical or scientific evidence that the competent authority of the Member State of destination considered, including, where applicable, any relevant changes in the state of the art that have occurred since the national technical rule came into force; (d) a summary of the arguments put forward by the economic operator concerned that are relevant for the assessment under paragraph 1, if any; (e) the evidence demonstrating that the administrative decision is appropriate for the purpose of achieving the objective pursued and that the administrative decision does not go beyond what is necessary in order to attain that objective. 12. The administrative decision referred to in paragraph 9 of this Article shall specify the remedies available under the national law of the Member State of destination and the time limits applicable to those remedies. It shall also include a reference to the possibility for economic operators to use SOLVIT and the procedure under Article 8. 13. The administrative decision referred to in paragraph 9 shall not take effect before it has been notified to the economic operator concerned under that paragraph. Article 6 Temporary suspension of market access 1. When the competent authority of a Member State is carrying out an assessment of goods pursuant to Article 5, it may temporarily suspend the making available of those goods on the market in that Member State only if: (a) under normal or reasonably foreseeable conditions of use, the goods pose a serious risk to safety or health of persons or to the environment, including one where the effects are not immediate, which requires rapid intervention by the competent authority; or (b) the making available of the goods, or of goods of that type, on the market in that Member State is generally prohibited in that Member State on grounds of public morality or public security. 2. The competent authority of the Member State shall immediately notify the economic operator concerned, the Commission and the other Member States of any temporary suspension pursuant to paragraph 1 of this Article. The notification to the Commission and the other Member States shall be made by means of the system referred to in Article 11. In cases falling within point (a) of paragraph 1 of this Article, the notification shall be accompanied by a detailed technical or scientific justification demonstrating why the case falls within the scope of that point. Article 7 Notification through RAPEX or RASFF If the administrative decision referred to in Article 5 or the temporary suspension referred to in Article 6 is also a measure which is to be notified through the Rapid Information Exchange System (RAPEX) in accordance with Directive 2001/95/EC or through the Rapid Alert System for Food and Feed (RASFF) in accordance with Regulation (EC) No 178/2002, a separate notification to the Commission and the other Member States under this Regulation shall not be required, provided that the following conditions are met: (a) the RAPEX or RASFF notification indicates that the notification of the measure also serves as a notification under this Regulation; and (b) the supporting evidence required for the administrative decision under Article 5 or for the temporary suspension under Article 6 is included with the RAPEX or RASFF notification. Article 8 Problem-solving procedure 1. Where an economic operator affected by an administrative decision has submitted it to SOLVIT and where, during the SOLVIT procedure, the Home Centre or the Lead Centre requests the Commission to give an opinion in order to assist in solving the case, the Home Centre and the Lead Centre shall provide the Commission with all relevant documents relating to the administrative decision concerned. 2. After receiving the request referred to in paragraph 1, the Commission shall assess whether the administrative decision is compatible with the principle of mutual recognition and with the requirements of this Regulation. 3. For the purposes of the assessment referred to in paragraph 2 of this Article, the Commission shall consider the administrative decision notified in accordance with Article 5(9) and the documents and information provided within the SOLVIT procedure. Where additional information or documents are needed for the purposes of the assessment referred to in paragraph 2 of this Article, the Commission shall, without undue delay, request the relevant SOLVIT Centre to enter into communication with the economic operator concerned or with the competent authorities which took the administrative decision, for the purpose of obtaining such additional information or documents. 4. Within 45 working days of receipt of the request referred to in paragraph 1, the Commission shall complete its assessment and issue an opinion. Where appropriate, the Commission's opinion shall identify any concerns that should be addressed in the SOLVIT case or shall make recommendations to assist in solving the case. The 45 working day period does not include the time necessary for the Commission to receive the additional information and documents as provided for in paragraph 3. 5. Where the Commission has been informed that the case is solved during the assessment referred to in paragraph 2, the Commission shall not be required to issue an opinion. 6. The Commission's opinion shall be communicated through the relevant SOLVIT Centre to the economic operator concerned and to the relevant competent authorities. That opinion shall be notified by the Commission to all Member States by means of the system referred to in Article 11. The opinion shall be taken into account during the SOLVIT procedure referred to in paragraph 1 of this Article. CHAPTER III ADMINISTRATIVE COOPERATION, MONITORING AND COMMUNICATION Article 9 Tasks of the Product Contact Points 1. Member States shall designate and maintain Product Contact Points on their territory and shall ensure that their Product Contact Points have sufficient powers and adequate resources for the proper performance of their tasks. They shall ensure that Product Contact Points deliver their services in accordance with Regulation (EU) 2018/1724. 2. Product Contact Points shall provide the following information online: (a) information on the principle of mutual recognition and the application of this Regulation in the territory of their Member State, including information on the procedure set out in Article 5; (b) the contact details, by means of which the competent authorities within that Member State may be contacted directly, including the particulars of the authorities responsible for supervising the implementation of the national technical rules applicable in the territory of their Member State; (c) the remedies and procedures available in the territory of their Member State in the event of a dispute between the competent authority and an economic operator, including the procedure set out in Article 8. 3. Where necessary to complement the information provided online under paragraph 2, Product Contact Points shall provide, at the request of an economic operator or a competent authority of another Member State, any useful information, such as electronic copies of, or online access to, the national technical rules and national administrative procedures applicable to specific goods or goods of a specific type in the territory in which the Product Contact Point is established or information on whether those goods or goods of that type are subject to prior authorisation under national law. 4. Product Contact Points shall respond within 15 working days of receiving any request under paragraph 3. 5. Product Contact Points shall not charge any fee for the provision of the information under paragraph 3. Article 10 Administrative cooperation 1. The Commission shall provide for and ensure efficient cooperation among the competent authorities and the Product Contact Points of the various Member States through the following activities: (a) facilitating and coordinating the exchange and collection of information and best practices with regard to the application of the principle of mutual recognition; (b) supporting the functioning of the Product Contact Points and enhancing their cross-border cooperation; (c) facilitating and coordinating the exchange of officials among Member States and the organisation of common training and awareness raising programmes for authorities and businesses. 2. Member States shall ensure that their competent authorities and Product Contact Points participate in the activities referred to in paragraph 1. 3. Upon a request by a competent authority of the Member State of destination pursuant to Article 5(7), the competent authorities in the Member State in which an economic operator claims to be lawfully marketing its goods shall provide the competent authority of the Member State of destination within 15 working days with any information relevant for verifying data and documents supplied by the economic operator during the assessment under Article 5 relating to those goods. The Product Contact Points may be used to facilitate contacts between the relevant competent authorities in accordance with the time limit for providing the requested information set out in Article 9(4). Article 11 Information and communication system 1. For the purposes of Articles 5, 6 and 10 of this Regulation, the information and communication system set out in Article 23 of Regulation (EC) No 765/2008 shall be used, except as provided in Article 7 of this Regulation. 2. The Commission shall adopt implementing acts specifying the details and functionalities of the system referred to in paragraph 1 of this Article for the purposes of this Regulation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2). CHAPTER IV FINANCING Article 12 Financing of activities in support of this Regulation 1. The Union may finance the following activities in support of this Regulation: (a) awareness-raising campaigns; (b) education and training; (c) exchange of officials and of best practices; (d) cooperation among Product Contact Points and competent authorities, and the technical and logistic support for this cooperation; (e) the collection of data related to the functioning of the principle of mutual recognition and its impact on the Single Market for goods. 2. The Union's financial assistance with respect to activities in support of this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (18), either directly or by entrusting budget implementation tasks to the entities listed in point (c) of Article 62(1) of that Regulation. 3. The appropriations allocated to activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force. Article 13 Protection of the financial interests of the Union 1. The Commission shall take appropriate measures to ensure that, when activities financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties. 2. The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds under this Regulation. 3. The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (19) and Council Regulation (Euratom, EC) No 2185/96 (20) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under this Regulation. 4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions, resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences. CHAPTER V EVALUATION AND COMMITTEE PROCEDURE Article 14 Evaluation 1. By 20 April 2025, and every four years thereafter, the Commission shall carry out an evaluation of this Regulation in light of the objectives that it pursues and shall submit a report thereon to the European Parliament, to the Council and to the European Economic and Social Committee. 2. For the purposes of paragraph 1 of this Article, the Commission shall use the information available in the system referred to in Article 11 and any data collected in the course of activities referred to in point (e) of Article 12(1). The Commission may also ask Member States to submit any relevant information for evaluating the free movement of goods lawfully marketed in another Member State or for evaluating the effectiveness of this Regulation, as well as an assessment of the functioning of the Product Contact Points. Article 15 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. CHAPTER VI FINAL PROVISIONS Article 16 Repeal Regulation (EC) No 764/2008 is repealed with effect from 19 April 2020. References to the repealed Regulation shall be construed as references to this Regulation. Article 17 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 19 April 2020. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 19 March 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 283, 10.8.2018, p. 19. (2) Position of the European Parliament of 14 February 2019 (not yet published in the Official Journal) and decision of the Council of 5 March 2019. (3) Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008, p. 21). (4) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (5) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (6) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). (7) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (8) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1). (9) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). (10) Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549). (11) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). (12) Commission Recommendation 2013/461/EU of 17 September 2013 on the principles governing SOLVIT (OJ L 249, 19.9.2013, p. 10). (13) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1). (14) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (15) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (16) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (17) OJ L 123, 12.5.2016, p. 1. (18) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (19) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (20) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2.). ANNEX Mutual recognition declaration for the purposes of Article 4 of Regulation (EU) 2019/515 of the European Parliament and of the Council (1) Part I 1. Unique identifier for the goods or type of goods: \u2026 [Note: insert the goods identification number or other reference marker that uniquely identifies the goods or type of goods] 2. Name and address of the economic operator: \u2026 [Note: insert the name and address of the signatory of Part I of the mutual recognition declaration: the producer and, where applicable, its authorised representative, or the importer, or the distributor] 3. Description of the goods or type of goods subject of the mutual recognition declaration: \u2026 [Note: the description should be sufficient to enable the goods to be identified for traceability reasons. It may be accompanied by a photograph, where appropriate] 4. Declaration and information on the lawfulness of the marketing of the goods or that type of goods 4.1. The goods or type of goods described above, including their characteristics, comply with the following rules applicable in \u2026 [Note: identify the Member State in which the goods or that type of goods are claimed to be lawfully marketed]: \u2026 [Note: insert the title and official publication reference, in each case, of the relevant rules applicable in that Member State and reference of the authorisation decision if the goods were subject to a prior authorisation procedure], or the goods or type of goods described above are not subject to any relevant rules in \u2026 [Note: identify the Member State in which the goods or that type of goods are claimed to be lawfully marketed]. 4.2. Reference of the conformity assessment procedure applicable to the goods or that type of goods, or reference of test reports for any tests performed by a conformity assessment body, including the name and address of that body (if such procedure was carried out or if such tests were performed): \u2026 5. Any additional information considered relevant to an assessment of whether the goods or that type of goods are lawfully marketed in the Member State indicated in point 4.1: \u2026 6. This part of the mutual recognition declaration has been drawn up under the sole responsibility of the economic operator identified under point 2. Signed for and on behalf of: (place and date): (name, function) (signature): Part II 7. Declaration and information on the marketing of the goods or that type of goods 7.1. The goods or that type of goods described in Part I are made available to end users on the market in the Member State indicated in point 4.1. 7.2. Information that the goods or that type of goods are made available to the end users in the Member State indicated in point 4.1, including details of the date of when the goods were first made available to end users on the market in that Member State: \u2026 8. Any additional information considered relevant to an assessment of whether the goods or that type of goods are lawfully marketed in the Member State indicated in point 4.1: \u2026 9. This part of the mutual recognition declaration has been drawn up under the sole responsibility of \u2026 [Note: insert the name and address of the signatory of Part II of the mutual recognition declaration: the producer and, where applicable, its authorised representative, or the importer, or the distributor] Signed for and on behalf of: (place and date): (name, function) (signature): (1) Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1).", "summary": "Mutual recognition of goods Mutual recognition of goods SUMMARY OF: Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another EU country WHAT IS THE AIM OF OF THE REGULATION? It aims to strengthen the internal market by improving the application of the mutual recognition principle* in the field of goods and removing unjustified barriers to trade. It does so by: defining the principle\u2019s rights and obligations for national authorities and businesses when goods are sold in another EU country; providing safeguards when mutual recognition would be denied in individual cases; reinforcing the role of national product contact points as providers of information and points of communication between national authorities and companies. The legislation replaces Regulation (EC) No 764/2008. KEY POINTS The mutual recognition principle ensures market access for goods that are not, or are only partly, subject to EU harmonisation legislation. The regulation applies to: all types of goods lawfully marketed in another EU country, including agricultural and fisheries products, irrespective of the way they are produced and processed; national administrative decisions that restrict or deny access to that country\u2019s market to such goods. When a competent authority in the importing country intends to assess the goods, businesses may use a voluntary mutual recognition declaration to demonstrate that the goods are lawfully marketed in another EU country. National authorities assessing imported goods under the mutual recognition principle must: immediately contact the business concerned explaining the planned assessment; allow the goods to be distributed and sold while they make the assessment (unless there is a prior authorisation procedure for the goods in their country or if they temporarily suspend market access); accept a mutual recognition declaration, together with supporting evidence necessary to verify the information contained in it , as sufficient to demonstrate that the goods are lawfully marketed in another EU country. If no declaration is supplied, the competent authority may request the business concerned to provide documentation and information about both the characteristics of the goods or type of goods in question and the lawful marketing of the goods in another EU country; take due account of the content of test reports or certificates issued by a conformity assessment body that have been provided by any business as part of the assessment; notify the business immediately \u2014 and the European Commission and EU countries within 20 days \u2014 if it decides to deny or restrict market access to the goods; when adopting a negative administrative decision, set out in a sufficiently detailed and reasoned manner why they restrict or deny market access, including the following the national technical rule on which the decision is basedthe legitimate public interest grounds justifying the use of the national technical rulethe scientific and technical evidence considereda summary of the relevant arguments the business concerned put forwardevidence demonstrating that the decision is proportionatethe various national remedies open to the business and their time limits, including the possibility to use the free service SOLVIT (which may lead to an Opinion of the Commission). National authorities assessing imported goods may temporarily suspend their sale or distribution, immediately informing the business, the Commission and EU countries, if: under normal or reasonably foreseeable conditions of use, the goods pose a serious risk to safety or health of persons or to the environment, including one where the effects are not immediate, which requires rapid intervention by the competent authority; or the making available of the goods, or of goods of that type, on the market in that EU country is generally prohibited in that EU country on grounds of public morality or public security. If SOLVIT centres are not able to find a good solution in an individual case using the SOLVIT procedure, the Commission may assist in solving the case at the request of any of the SOLVIT Centres involved by issuing an Opinion. For this, the Commission: must assess whether the national authority\u2019s decision is compatible with the mutual recognition principle and the requirements of the regulation; if additional information or documents are needed, must ask the relevant SOLVIT Centre to contact the business or the competent authority, to obtain such additional information or documents; must issue an Opinion within 45 days; the opinion must be communicated to the business and the national authority by the relevant SOLVIT Centre. The Commission must notify the Opinion to the EU countries; where appropriate, the Commission\u2019s Opinion must identify any concerns that should be addressed in the SOLVIT case or must make recommendations to assist in solving the case. Each EU country must establish and maintain on its territory product contact points, and ensure they have sufficient powers and adequate resources. The product contact points must: provide online information on the mutual recognition principle and the application of the regulation in their countrycontact details of the relevant national authorities, including those of the authorities responsible for supervising the implementation of the national technical rules applicable in their countryremedies and procedures available in their country in the event of a dispute, including the SOLVIT procedure set out in the regulation; respond, free of charge, within 15 days to requests from companies or national authorities for further information; when necessary, help to arrange contacts between national authorities in relation to the assessment procedure of the regulation. The EU may finance the following activities in support of the regulation: awareness-raising campaigns; education and training; cooperation among product contact points and competent authorities, and the technical and logistic support for this cooperation; the collection of data related to the functioning of the principle of mutual recognition and its impact on the EU\u2019s single market for goods; exchange of officials and of best practices. The Commission must carry out an evaluation of the regulation by 20 April 2025, and every 4 years thereafter, and submit a report to the European Parliament, the Council and the European Economic and Social Committee. Implementing act Commission Implementing Regulation (EU) 2020/1668 sets out the details necessary to adapt Information and Communication System for Market surveillance (ICSMS) for the purposes of mutual recognition. The implementing regulation introduces the use of the ICSMS for: notifications of administrative decisions (Article 5); notifications of temporary suspensions (Article 6); notification of the Commission\u2019s opinion to all EU countries (Article 8); exchange of information between the competent authorities of the EU countries in charge of verifying data and documents supplied by the businesses during an assessment (Article 10). FROM WHEN DOES THE REGULATION APPLY? It has applied since 19 April 2020. BACKGROUND For more information, see: Mutual recognition of goods (European Commission). KEY TERMS Mutual recognition principle: a principle of EU law under which EU countries may not prohibit the sale on their territory of goods which are lawfully marketed in another EU country. The only exception is where EU countries have legitimate public interest grounds for restricting or denying market access and the restriction is justified and proportionate. MAIN DOCUMENT Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, pp. 1-18) RELATED DOCUMENTS Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1-44) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, pp. 1-38) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1-142) Successive amendments to Regulation (EU) 2017/625 have been incorporated into the original text. This consolidated version is of documentary value only. Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, pp. 1-15) Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, pp. 549-607) See consolidated version. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30-47) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, pp. 1-24) See consolidated version. Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4-17) See consolidated version. last update 27.11.2020"}
{"article": "29.3.2019 EN Official Journal of the European Union L 91/25 REGULATION (EU) 2019/517 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 19 March 2019 on the implementation and functioning of the .eu top-level domain name and amending and repealing Regulation (EC) No 733/2002 and repealing Commission Regulation (EC) No 874/2004 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 172 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The .eu top-level domain (TLD) was established by Regulation (EC) No 733/2002 of the European Parliament and of the Council (3) and by Commission Regulation (EC) No 874/2004 (4). Since the adoption of those regulations, the political and legislative context in the Union, the online environment and the market have changed considerably. (2) The rapid evolution of the TLD market and the dynamic digital landscape requires a future-proof and flexible regulatory environment. The .eu TLD is one of the largest country code TLDs (ccTLDs). The .eu TLD is used by the Union institutions, agencies and bodies, including for European projects and initiatives. The purpose of the .eu TLD is, through good management, to help enhance the Union identity and promote Union values online, such as multilingualism, respect for users' privacy and security and respect for human rights, as well as specific online priorities. (3) TLDs are an essential component of the hierarchical structure of the domain name system (DNS) which ensure an interoperable system of unique identifiers, available throughout the world, on any application and any network. (4) The .eu TLD should promote the use of, and access to, internet networks in accordance with Articles 170 and 171 TFEU by providing registration complementary to existing ccTLDs and to the global registration of generic TLDs. (5) The .eu TLD, which is a clear and easily recognisable label, should provide a clearly identifiable link with the Union and the European market place. It should enable undertakings, organisations and natural persons within the Union to register a domain name under the .eu TLD. The existence of such a domain name is important to strengthen the Union's identity online. Regulation (EC) No 733/2002 should therefore be amended in order to allow Union citizens to register a .eu TLD name, regardless of their place of residence, from 19 October 2019. (6) Domain names in the .eu TLD should be allocated to eligible parties, subject to availability. (7) The Commission should promote cooperation between the Registry, the European Union Intellectual Property Office (EUIPO) and other Union agencies, with a view to combating the speculative and abusive registrations of domain names, including cybersquatting, and providing simple administrative procedures, in particular for small and medium-sized enterprises (SMEs). (8) To ensure the better protection of the right of the parties to contract with, respectively, the Registry and Registrars, disputes with regard to the registration of domain names in the .eu TLD should be solved by bodies located in the Union applying the relevant national law, without prejudice to rights and obligations recognised by the Member States or by the Union arising from international instruments. (9) The Commission should, on the basis of an open, transparent and non-discriminatory selection procedure, having regard to cost-efficiency and administrative simplicity, designate a Registry for the .eu TLD. In order to support the digital single market, to build an online European identity and to encourage cross-border online activities, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the eligibility and selection criteria and the procedure for the designation of the Registry. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (5). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (10) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt the lists of reserved and blocked domain names by Member States, to establish the principles that are to be included in the contract between the Commission and the Registry and to designate the Registry on duly justified imperative grounds of urgency, in particular to ensure the continuity of the service. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). Such lists should be compiled subject to the domain names' availability taking into account domain names at second level already reserved or registered by the Member States. (11) The Commission should enter into a contract with the designated Registry, which should include the detailed principles and procedures that apply to the Registry for the organisation, administration and management of the .eu TLD. The contract should be of a fixed duration and should be renewable once without the need for a new selection procedure. (12) The principles and procedures relating to the functioning of the .eu TLD should be annexed to the contract between the Commission and the designated Registry. (13) This Regulation is without prejudice to the application of the rules on competition provided for in Articles 101 and 102 TFEU. (14) The Registry should comply with the principles of non-discrimination and transparency, and should implement measures to safeguard fair competition that are to be authorised in advance by the Commission, in particular when the Registry provides services to undertakings with whom it competes on downstream markets. (15) The Internet Corporation for Assigned Names and Numbers (ICANN) is at present responsible for coordinating the delegation of codes representing ccTLD to Registries. The Registry should enter into an appropriate contract with ICANN that provides for the delegation of the .eu ccTLD code, taking account of the relevant principles adopted by the Governmental Advisory Committee (GAC). (16) The Registry should enter into an appropriate escrow agreement to ensure continuity of service, and in particular to ensure that it is possible to continue to provide services to the local internet community with minimum disruption in the event of re-delegation or other unforeseen circumstances. The Registry should submit an electronic copy of the current content of the .eu TLD database to the escrow agent on a daily basis. (17) The alternative dispute resolution (ADR) procedures to be adopted should comply with Directive 2013/11/EU of the European Parliament and of the Council (7) and take into account the international best practices in this area and in particular the relevant recommendations of the World Intellectual Property Organization, to ensure that speculative and abusive registrations are avoided as far as possible. Those ADR procedures should respect uniform procedural rules that are in line with those set out in ICANN's Uniform Domain Name Dispute-Resolution Policy. (18) The policy on the abusive registration of .eu domain names should provide for verification by the Registry of the data that it receives, specifically data concerning the identity of registrants, as well as revocation and blocking from future registration of domain names considered by a final decision of a Member State court to be defamatory, racist or otherwise contrary to the law of the Member State. The Registry should take the utmost care to ensure the correctness of the data that it receives and holds. The revocation procedure should allow the domain name holder a reasonable opportunity to rectify any breach of the eligibility criteria, registration requirements or outstanding debts before the revocation is to take effect. (19) A domain name that is identical or confusingly similar to a name in respect of which a right is established by Union or national law and which has been registered without rights or legitimate interest in the name, should, in principle, be revoked and, where necessary, transferred to the legitimate holder. Where such a domain name has been found to have been used in bad faith, it should always be revoked. (20) The Registry should adopt clear policies aiming to ensure the timely identification of abusive registrations of domain names and, where necessary, should cooperate with competent authorities and other public bodies relevant to cybersecurity and information security which are specifically involved in the fight against such registrations, such as national computer emergency response teams (CERTs). (21) The Registry should support law enforcement agencies in the fight against crime, by implementing technical and organisational measures aimed at enabling competent authorities to have access to the data in the Registry for purposes of the prevention, detection, investigation and prosecution of crimes, as provided for by Union or national law. (22) This Regulation should be implemented in compliance with the principles relating to privacy and the protection of personal data. The Registry should comply with the relevant Union data protection rules, principles and guidelines, in particular with the relevant security requirements, with the principles of necessity, proportionality, purpose limitation and proportionate data retention period. Also, personal data protection by design and data protection by default should be embedded in all data-processing systems and databases developed and maintained. (23) In order to ensure effective periodic supervision, the Registry should be audited at its own expense at least every two years by an independent body with the purpose of confirming, by means of a conformity assessment report, that the Registry complies with the requirements laid down in this Regulation. The Registry should submit that report to the Commission in accordance with its contract with the Commission. (24) The contract between the Commission and the Registry should provide for procedures to improve the organisation, administration and management of the .eu TLD by the Registry in accordance with the instructions of the Commission resulting from the Commission's supervisory activities as provided for in this Regulation. (25) In its conclusions of 27 November 2014, entitled \u2018Internet Governance\u2019, the Council reaffirmed the Union's commitment to promote multistakeholder governance structures that are based on a coherent set of global internet governance principles. Inclusive internet governance refers to the development and applications of shared principles, norms, rules, decision-making procedures and programmes that shape the evolution and use of the internet by governments, the private sector, civil society, international organisations and the technical community, all acting in their respective roles. (26) A .eu Multistakeholder Advisory Group should be set up with the role of advising the Commission in order to strengthen and widen input into the good governance of the Registry. The Group should reflect the internet governance multistakeholder model, and its members, apart from those drawn from Member State authorities and international organisations, should be appointed by the Commission on the basis of an open, non-discriminatory and transparent procedure. The representatives drawn from the Member State authorities should be appointed on the basis of a rotation system ensuring sufficient continuity of participation in the Group. (27) The Commission should carry out an evaluation of the effectiveness and functioning of the .eu TLD. That evaluation should have regard to the designated Registry working practices and the relevance of the Registry's tasks. The Commission should also submit regular reports on the functioning of the .eu TLD name to the European Parliament and to the Council. (28) This Regulation respects the fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019), as enshrined in the Treaties, in particular the protection of personal data, the freedom of expression and information, and the protection of consumers. Appropriate Union procedures should be observed when ensuring that provisions in national law that affect this Regulation comply with Union law and, in particular, the Charter. The Registry should seek guidance from the Commission in cases of doubt with regard to compliance with Union law. (29) Since the objective of this Regulation, namely the implementation of a pan-European TLD in addition to the national ccTLDs, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (30) In order to limit any risk of disruption to the services of the .eu TLD during the implementation of the new regulatory framework, transitional provisions are laid down in this Regulation. (31) Regulation (EC) No 733/2002 should therefore be amended and repealed, and Regulation (EC) No 874/2004 should be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and objectives 1. This Regulation implements the .eu country code top-level domain (\u2018ccTLD\u2019) and its available variants in other scripts, in order to support the digital single market, to build an online Union identity and to encourage cross-border online activities. It also lays down the conditions for its implementation, including the designation and characteristics of the Registry. This Regulation also establishes the legal and general policy framework within which the designated Registry is to function. 2. This Regulation applies without prejudice to arrangements in Member States regarding their national ccTLDs. Article 2 Definitions For the purposes of this Regulation: (1) \u2018Registry\u2019 means the entity entrusted with the organisation, administration and management of the .eu TLD, including the maintenance of the corresponding databases and the associated public query services, the registration of domain names, the operation of the Registry of domain names, the operation of the Registry's TLD name servers, and the distribution of TLD zone files across name servers; (2) \u2018Registrar\u2019 means a natural or legal person that, on the basis of a contract with the Registry, provides domain name registration services to registrants; (3) \u2018Internationalised Domain Name protocols\u2019 means standards and protocols that support the use of domain names in characters that are not American Standard Code for Information Interchange (ASCII) characters; (4) \u2018WHOIS database\u2019 means the collection of data containing information on the technical and administrative aspects of the .eu TLD registrations; (5) \u2018principles and procedures on the functioning of the .eu TLD\u2019 means detailed rules concerning the functioning and management of the .eu TLD; (6) \u2018registration\u2019 means the series of acts and procedural steps, from initiation to completion, taken by Registrars and the Registry upon the request of a natural or legal person for the purpose of implementing the registration of a domain name for a specified duration. CHAPTER II IMPLEMENTATION OF THE .eu TLD SECTION 1 General principles Article 3 Eligibility criteria Registration of one or more domain names under the .eu TLD can be requested by any of the following: (a) a Union citizen, independently of their place of residence; (b) a natural person who is not a Union citizen and who is a resident of a Member State; (c) an undertaking that is established in the Union; and (d) an organisation that is established in the Union without prejudice to the application of national law. Article 4 Registration and revocation of domain names 1. A domain name shall be allocated to the eligible party whose request was first received by the Registry in the technically correct manner as laid down by the procedures for registration requests on the basis of point (b) of Article 11. 2. A registered domain name shall be unavailable for further registration until the registration has expired without renewal, or until the domain name has been revoked. 3. The Registry may revoke a domain name at its own initiative, without submitting the dispute to an ADR or judicial procedure, on the following grounds: (a) there are outstanding unpaid debts owed to the Registry; (b) the non-fulfilment by the domain name holder of the eligibility criteria pursuant to Article 3; (c) the breach by the domain name holder of the requirements for registration requests laid down on the basis of points (b) and (c) of Article 11. 4. A domain name may also be revoked, and where necessary subsequently transferred to another party, following an appropriate ADR or judicial procedure, in accordance with the principles and procedures on the functioning of the .eu TLD laid down pursuant to Article 11, where that name is identical or confusingly similar to a name in respect of which a right is established by Union or national law, and where it: (a) has been registered by its holder without rights or legitimate interest in the name; or (b) has been registered or is being used in bad faith. 5. Where a domain name is found by a decision of a court of a Member State to be defamatory, racist or contrary to public policy or public security under Union law, or national law that complies with Union law, that domain name shall be blocked by the Registry upon notification of the court's decision and shall be revoked upon notification of the final court decision. The Registry shall block from future registration those domain names which have been subject to such a court order for as long as that order remains valid. 6. Domain names registered under the .eu TLD shall be transferable only to parties eligible for registration of .eu TLD names. Article 5 Languages, applicable law and jurisdiction 1. The registration of domain names shall be carried out in all the characters of the official languages of the Union institutions, in accordance with the available international standards as allowed by the relevant Internationalised Domain Name protocols. 2. Without prejudice to Regulation (EU) No 1215/2012 of the European Parliament and of the Council (8) or to the rights and obligations recognised by the Member States or by the Union that arise from international instruments, neither contracts between the Registry and Registrars nor contracts between Registrars and registrants of domain names shall designate a law other than that of one of the Member States as the applicable law, nor shall they designate a court, arbitration court or other body located outside the Union as the relevant dispute resolution body. Article 6 Reservation of domain names 1. The Registry may reserve or register a number of domain names considered necessary for its operational functions under the contract referred to in Article 8(4). 2. The Commission may instruct the Registry to reserve or to register a domain name directly under the .eu TLD for use by the Union institutions and bodies. 3. Member States may, without prejudice to domain names that have already been reserved or registered, notify to the Commission a list of domain names which: (a) are not to be registered pursuant to their national law; or (b) may be registered or reserved only at the second-level by the Member States. With respect to point (b) of the first subparagraph, such domain names shall be limited to broadly recognised geographical or geopolitical terms which affect the Member States' political or territorial organisation. 4. The Commission shall adopt the lists notified by the Member States by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(2). Article 7 Registrars 1. The Registry shall accredit Registrars in accordance with reasonable, transparent and non-discriminatory accreditation procedures which have been approved in advance by the Commission. The Registry shall make the accreditation procedures publicly available in readily accessible form. 2. The Registry shall apply equivalent conditions in equivalent circumstances in relation to accredited .eu Registrars that provide equivalent services. The Registry shall provide those Registrars with services and information under the same conditions, and of the same quality, as provided for its own equivalent services. SECTION 2 Registry Article 8 Designation of the Registry 1. The Commission shall adopt delegated acts in accordance with Article 18 to supplement this Regulation by establishing the eligibility and selection criteria and the procedure for the designation of the Registry. 2. The Commission shall set out the principles to be included in the contract between the Commission and the Registry, by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(2). 3. The Commission shall designate an entity as the Registry following the completion of the procedure referred to in paragraphs 1 and 2. 4. The Commission shall enter into a contract with the designated Registry. The contract shall specify the rules, policies and procedures for the provision of services by the Registry and the conditions according to which the Commission is to supervise the organisation, administration and management of the .eu TLD by the Registry. The contract shall be limited in time and shall be renewable once without the need to organise a new selection procedure. The contract shall reflect the obligations of the Registry and shall include the principles and procedures on the functioning of the .eu TLD laid down on the basis of Articles 10 and 11. 5. By way of derogation from paragraphs 1, 2 and 3, the Commission may, where imperative grounds of urgency exist, designate the Registry by means of immediately applicable implementing acts in accordance with the procedure referred to in Article 17(3). Article 9 Characteristics of the Registry 1. The Registry shall be a not-for-profit organisation. It shall have its registered office, central administration and principal place of business within the territory of the Union. 2. The Registry may impose fees. Those fees shall be directly related to the costs incurred. Article 10 Obligations of the Registry The Registry shall be required to: (a) promote the .eu TLD across the Union and in third countries; (b) comply with the rules, policies and procedures laid down in this Regulation, with the contract referred to in Article 8(4), and, in particular, with Union data protection law; (c) organise, administer and manage the .eu TLD in the general public interest and ensure in all aspects of the administration and management of the .eu TLD, high quality, transparency, security, stability, predictability, reliability, accessibility, efficiency, non-discrimination, fair conditions of competition and consumer protection; (d) enter into an appropriate contract providing for the delegation of the .eu TLD code, subject to the prior consent of the Commission; (e) perform the registration of domain names in the .eu TLD where requested by any eligible party referred to in Article 3; (f) ensure, without prejudice to any court proceedings, and subject to adequate procedural guarantees for the parties concerned, the possibility for Registrars and registrants to resolve any contractual dispute with the Registry by means of ADR; (g) ensure the availability and integrity of the databases of domain names; (h) at its own expense and with the consent of the Commission, enter into an agreement with a reputable trustee or other escrow agent established within the territory of the Union designating the Commission as the beneficiary of the escrow agreement, and submit an up-to-date electronic copy of the content of the .eu TLD database to the respective trustee or escrow agent on a daily basis; (i) implement the lists referred to in Article 6(3); (j) promote the objectives of the Union in the field of internet governance, inter alia by participating in international forums; (k) publish the principles and procedures on the functioning of the .eu TLD laid down on the basis of Article 11 in all of the official languages of the Union institutions; (l) at its own expense, undertake an audit by an independent body at least every two years to certify its compliance with this Regulation and send the outcome of such audits to the Commission; (m) participate, where requested by the Commission, in the work of the .eu Multistakeholder Advisory Group and cooperate with the Commission to improve the functioning and management of the .eu TLD. Article 11 Principles and procedures on the functioning of the .eu TLD The contract, concluded between the Commission and the designated Registry in accordance with Article 8(4) shall contain the principles and procedures concerning the functioning of the .eu TLD, in compliance with this Regulation, including the following: (a) an ADR policy; (b) requirements and procedures for registration requests, a policy on the verification of registration criteria, a policy on the verification of registrants' data, and a policy on the speculative registration of domain names; (c) a policy on abusive registration of domain names and a policy on the timely identification of domain names that have been registered and used in bad faith, referred to in Article 4; (d) a policy on the revocation of domain names; (e) the treatment of intellectual property rights; (f) measures to enable competent authorities to have access to data in the Registry for the purposes of prevention, detection, investigation and prosecution of crime, as provided by Union law or national law that complies with Union law, subject to appropriate checks and balances; (g) detailed procedures by means of which to amend the contract. Article 12 WHOIS database 1. The Registry shall set up and manage, with due diligence, a WHOIS database facility for the purpose of ensuring the security, stability and resilience of the .eu TLD by providing accurate and up-to-date registration information about the domain names under the .eu TLD. 2. The WHOIS database shall contain relevant information about the points of contact administering the domain names under the .eu TLD and the holders of the domain names. The information on the WHOIS database shall not be excessive in relation to the purpose of the database. The Registry shall comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (9). SECTION 3 Oversight of the registry Article 13 Supervision 1. The Commission shall monitor and supervise the organisation, administration and management of the .eu TLD by the Registry. 2. The Commission shall ascertain the soundness of financial management of the Registry and its compliance with this Regulation and with the principles and procedures on the functioning of the .eu TLD as referred to in Article 11. The Commission may request information from the Registry to that end. 3. In accordance with its supervisory activities, the Commission may convey specific instructions to the Registry for correcting or improving the organisation, administration and management of the .eu TLD. 4. The Commission may, as appropriate, consult the .eu Multistakeholder Advisory Group and other relevant stakeholders and may seek expert advice on the results of the supervisory activities provided for in this Article and on ways to improve the organisation, administration and management of the .eu TLD by the Registry. Article 14 .eu Multistakeholder Advisory Group 1. The Commission shall establish a .eu Multistakeholder Advisory Group. The .eu Multistakeholder Advisory Group shall have the following tasks: (a) to advise the Commission on the implementation of this Regulation; (b) to issue opinions to the Commission on strategic matters relating to the management, organisation and administration of the .eu TLD, including issues relating to cybersecurity and data protection; (c) to advise the Commission on matters relating to the monitoring and supervision of the Registry, in particular with regard to the audit referred to in point (l) of Article 10; (d) to advise the Commission on best practices as regards policies and measures against abusive registrations of domain names, in particular registrations without rights or legitimate interests and registrations used in bad faith. 2. The Commission shall take account of any advice provided by the .eu Multistakeholder Advisory Group in implementing this Regulation. 3. The .eu Multistakeholder Advisory Group shall be composed of representatives of stakeholders that are established in the Union. Those representatives shall be drawn from the private sector, the technical community, civil society and academia, as well as Member States' authorities and international organisations. Representatives other than those drawn from Member States' authorities and international organisations shall be appointed by the Commission on the basis of an open, non-discriminatory and transparent procedure, taking the utmost account the principle of gender equality. 4. Notwithstanding paragraph 3, the .eu Multistakeholder Advisory Group may include one representative of stakeholders established outside the Union. 5. The .eu Multistakeholder Advisory Group shall be chaired by a representative of the Commission or by a person appointed by the Commission. The Commission shall provide secretarial services to the .eu Multistakeholder Advisory Group. CHAPTER III FINAL PROVISIONS Article 15 Reservation of rights The Union shall retain all rights relating to the .eu TLD including, in particular, any intellectual property rights or other rights to the Registry databases that are required to ensure the implementation of this Regulation, as well as the right to re-designate the Registry. Article 16 Evaluation and review 1. By 13 October 2027 and every three years thereafter, the Commission shall assess the implementation, effectiveness and functioning of the .eu TLD, based in particular on the information submitted by the Registry pursuant to point (l) of Article 10. 2. By 30 June 2020, the Commission shall assess, taking into account current practice, whether and how the Registry is to cooperate with the EUIPO and other Union agencies with a view to combating speculative and abusive registrations of domain names, and whether and how simple administrative procedures are to be provided for, in particular with regard to SMEs. The Commission may propose further measures in that regard, if necessary. 3. By 13 October 2024, the Commission shall assess the possibility of extending the criteria set out in Article 9 and may, if appropriate, submit a legislative proposal. 4. The Commission shall submit a report to the European Parliament and the Council on the findings of the assessment referred to in paragraphs 1 and 2. Article 17 Committee procedure 1. The Commission shall be assisted by the Communications committee (COCOM) established by Directive (EU) 2018/1972 of the European Parliament and of the Council (10). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. Article 18 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 8(1) shall be conferred on the Commission for a period of five years from 18 April 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 8(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 8(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 19 Transitional provisions 1. Domain name holders that have domain names that were registered pursuant to point (b) of Article 4(2) of Regulation (EC) No 733/2002 shall retain their rights in relation to the existing registered domain names. 2. By 12 October 2021, the Commission shall take the necessary measures to designate an entity as the Registry and to enter into a contract with the Registry pursuant this Regulation. The contract shall be effective from 13 October 2022. 3. The contract concluded between the Commission and the Registry pursuant to point (c) of Article 3(1) of Regulation (EC) No 733/2002 shall continue to be effective until 12 October 2022. Article 20 Amendment of Regulation (EC) No 733/2002 In Article 4(2) of Regulation (EC) No 733/2002, point (b) is replaced by the following: \u2018(b) register domain names in the .eu TLD through any accredited .eu Registrar requested by: (i) a Union citizen, independently of their place of residence; (ii) a natural person who is not a Union citizen and who is a resident of a Member State; (iii) an undertaking that is established in the Union; or (iv) an organisation that is established in the Union, without prejudice to the application of national law.\u2019. Article 21 Repeal Regulations (EC) No 733/2002 and (EC) No 874/2004 are repealed with effect from 13 October 2022. Article 22 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 13 October 2022. However, Article 20 shall apply from 19 October 2019. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 19 March 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 367, 10.10.2018, p. 112. (2) Position of the European Parliament of 31 January 2019 (not yet published in the Official Journal) and decision of the Council of 18 February 2019. (3) Regulation (EC) No 733/2002 of the European Parliament and of the Council of 22 April 2002 on the implementation of the .eu Top Level Domain (OJ L 113, 30.4.2002, p. 1). (4) Commission Regulation (EC) No 874/2004 of 28 April 2004 laying down public policy rules concerning the implementation and functions of the .eu Top Level Domain and the principles governing registration (OJ L 162, 30.4.2004, p. 40). (5) OJ L 123, 12.5.2016, p. 1. (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Directive on consumer ADR) (OJ L 165, 18.6.2013, p. 63). (8) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (9) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (10) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36).", "summary": "The .eu top-level domain The .eu top-level domain SUMMARY OF: Regulation (EU) 2019/517 on the implementation and functioning of the .eu top-level domain name WHAT IS THE AIM OF THE REGULATION? The regulation updates the rules about the .eu top-level domain (TLD), as part of the EU\u2019s new digital single market strategy. It aims to reinforce the EU\u2019s online identity and encourage cross-border online activities. Due to the rapid evolution of the TLD market (for example new domain name extensions such as .com and .org have been introduced) and the volatility of the digital landscape a modernised, more flexible and sustainable regulatory environment for the .eu TLD was introduced by the regulation, replacing the old legal framework with a lighter, more efficient and future-proof principle-based legal instrument. The regulation creates a new governance structure, involving a separate multi-stakeholder body, with the goal of strengthening and widening input on the performance of the .eu TLD. It introduces new eligibility criteria to enable EU/EEA citizens to register a .eu domain, regardless of where they live. KEY POINTS Promoting and safeguarding EU values The purpose of the .eu domain, as a clear and easily recognisable label, is to contribute to strengthening the EU\u2019s profile and promote its values online, such as multilingualism, respect for user privacy and security, and respect for human rights. Eligibility for domain name registration A .eu domain may be requested by: EU and EEA citizens, wherever they live; non-EU citizens residing in an EU country; businesses established in the EU; and other organisations established in the EU, if permitted under applicable national law. Rules on revoking domain name registration The Registry* may revoke a domain name on its own initiative, on the following grounds: there are outstanding unpaid debts owed to the Registry; the domain name holder is ineligible; the domain name holder breaches the requirements for registration requests on the following grounds: a domain name deemed defamatory, racist or contrary to public policy or public security should be blocked subject to a court decisiona domain name that is identical or confusingly similar to a name for which a right is established by EU or national law, and which has been registered without rights or without a legitimate interest in the name should, in principle, be revoked, and where appropriate, transferred to the legitimate holderwhere such a domain name has been used in bad faith, it should always be revoked. Registry The designated Registry is a non-profit organisation able to impose fees for costs incurred, and will: promote the .eu TLD in the EU and worldwide; comply with the rules, policies and procedures in this regulation and its contract with the European Commission, and particularly EU data protection law; organise, administer and manage the .eu TLD in the general interest and assure high quality, transparency, security, stability, predictability, reliability, accessibility, efficiency, non-discrimination, a level playing field and consumer protection; ensure that abusive domain name registrations are quickly identified; cooperate with competent authorities and other public bodies responsible for cybersecurity and information security, such as national computer emergency response teams. Commission Implementing Regulation (EU) 2020/857 establishes the points to be included in the contract between the Commission and the Registry for the organisation, administration and management of the .eu TLD. These include: the principles of good governance and good management; security and consumer protection aspects; promotion of EU objectives in internet governance; having policies and procedures in place to actively combat speculative and abusive domain name registrations in the .eu TLD. WHOIS database* The Registry is responsible for setting up and managing a WHOIS database facility providing accurate and up-to-date registration information about the domain names including information about an administrative point of contact and domain name holders. .eu Multi-Stakeholder Advisory Group This group is responsible for advising the Commission on: implementation of this regulation;strategic issues related to the management, organisation and administration of the .eu TLD, including cyber-protection and data protection;good practices on combating abusive domain name registration. The Advisory Group is composed of representatives of EU-based stakeholders and a representative of stakeholders from outside the EU, chaired by a representative of the Commission or a person designated by the Commission. Evaluation and review By 13 October 2027, and then every 3 years, the Commission evaluates the effectiveness and functioning of the .eu TLD. By June 2020 at the latest, the Commission should evaluate the cooperation between the .eu Registry and the EU Intellectual Property Office (EUIPO) and other EU agencies with regard to combating speculative and abusive registration of domain names, and simplifying administrative procedures, in particular for small- and medium-sized enterprises. Repeal The regulation repeals Regulations (EC) No 733/2002 and (EC) No 874/2004 from 12 October 2022. FROM WHEN DOES THE REGULATION APPLY? It applies from 13 October 2022. The revised domain name eligibility criterion has applied since 19 October 2019. BACKGROUND For more information, see: The top-level domain .eu (European Commission). KEY TERMS Registry: the body which organises, administrates and manages the .eu TLD, including maintaining databases and the associated public query services, domain name registration, the operation of the Registry of domain names, and the operation of the Registry\u2019s TLD name servers. WHOIS database: the collection of data containing information on the technical and administrative aspects of .eu TLD registrations. MAIN DOCUMENT Regulation (EU) 2019/517 of the European Parliament and of the Council of 19 March 2019 on the implementation and functioning of the .eu top-level domain name and amending and repealing Regulation (EC) No 733/2002 and repealing Commission Regulation (EC) No 874/2004 (OJ L 91, 29.3.2019, pp. 25-35) RELATED DOCUMENTS Commission Implementing Regulation (EU) 2020/857 of 17 June 2020 laying down the principles to be included in the contract between the European Commission and the .eu top-level domain Registry in accordance with Regulation (EU) 2019/517 of the European Parliament and of the Council (OJ L 195, 19.6.2020, pp. 52-56) Commission Regulation (EC) No 874/2004 of 28 April 2004 laying down public policy rules concerning the implementation and functions of the .eu Top Level Domain and the principles governing registration (OJ L 162, 30.4.2004, pp. 40-50) Successive amendments to Regulation (EC) No 874/2004 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EC) No 733/2002 of the European Parliament and of the Council of 22 April 2002 on the implementation of the .eu Top Level Domain (OJ L 113, 30.4.2002, pp. 1-5) See consolidated version. last update 07.08.2020"}
{"article": "14.7.2021 EN Official Journal of the European Union L 249/38 REGULATION (EU) 2021/1153 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 172 and 194 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) In order to achieve smart, sustainable and inclusive growth, to stimulate job creation and to respect long-term decarbonisation commitments, the Union needs up-to-date, multimodal, high-performance infrastructure in its transport, energy and digital sectors to help connect and integrate the Union and all its islands and regions, including its remote, outermost, peripheral, mountainous and sparsely populated ones. Those connections should help to improve the free movement of persons, goods, capital and services. The trans-European networks should facilitate cross-border connections, foster greater economic, social and territorial cohesion, and contribute to a more competitive and sustainable social market economy and to combating climate change. (2) The aim of the Connecting Europe Facility (the \u201cCEF\u201d) is to accelerate investment in the field of trans-European networks and to leverage funding from both the public and the private sectors, while increasing legal certainty and respecting the principle of technological neutrality. The CEF should enable synergies between the transport, energy and digital sectors to be harnessed to the full, thus enhancing the effectiveness of Union action and enabling the costs of implementation to be minimised. (3) The CEF should also contribute to Union action against climate change and support environmentally and socially sustainable projects, including, where appropriate, climate change mitigation and adaptation actions. In particular, the contribution of the CEF to achieving the goals and objectives of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (4) (\u201cParis Agreement\u201d), as well as the 2030 climate and energy targets and long-term decarbonisation objective, should be reinforced. (4) The CEF should guarantee a high level of transparency and ensure public consultation in compliance with applicable Union and national law. (5) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Regulation is intended to contribute to mainstreaming climate actions and to the achievement of an overall target of at least 30 % of Union budget expenditure supporting climate objectives. In addition, this Regulation should contribute to the ambition of committing 7,5 % of annual spending under the Multiannual Financial Framework (the \u201cMFF\u201d) 2021-2027 to biodiversity objectives in the year 2024 and 10 % of annual spending under the MFF 2021-2027 to biodiversity objectives in 2026 and 2027 while taking into consideration the existing overlaps between climate and biodiversity objectives. Through its actions, the CEF should contribute 60 % of its overall financial envelope to climate objectives, based, inter alia, on the following coefficients: (i) 100 % for expenditure relating to railway infrastructure, charging infrastructure, alternative and sustainable fuels, clean urban transport, electricity transmission, electricity storage, smart grids, CO2 transport and renewable energy; (ii) 40 % for inland waterways and multimodal transport, as well as gas infrastructure, provided that it enables the use of renewable hydrogen or bio-methane to be increased. The detailed climate expenditure tracking coefficients applied should be consistent with those set out in Annex I to Regulation (EU) 2021/1060 of the European Parliament and of the Council (5), where applicable. Relevant actions will be identified during the preparation and implementation of the CEF, and reassessed in the context of the relevant evaluations and review processes. In order to prevent infrastructure from being vulnerable to potential long term climate change effects, and to ensure that the cost of greenhouse gas emissions arising from the project is included in the project\u2019s economic evaluation, projects supported by the CEF should be subject to climate proofing, where relevant, in accordance with guidance that should be developed by the Commission coherently with the guidance developed for other programmes of the Union. (6) According to Article 8 of the Treaty on the Functioning of the European Union (TFEU), in all its activities, the Union is to aim to eliminate inequalities, and to promote equality, between men and women. Gender equality, as well as equal rights and opportunities for all, and the mainstreaming of those objectives should be taken into account and promoted throughout the assessment, preparation, implementation and monitoring of the CEF. (7) In order to comply with the reporting obligations regarding the uptake of Union funds to support the measures taken with a view to complying with the objectives of Directive (EU) 2016/2284 of the European Parliament and of the Council (6), expenditure related to the reduction of emissions or air pollutants under that Directive should be tracked. (8) An important objective of the CEF is to deliver increased synergies and complementarity between the transport, energy and digital sectors. For that purpose, the CEF should provide for the adoption of work programmes that could address specific intervention areas, for instance as regards connected and automated mobility or sustainable alternative fuels. The enabling of digital communication could constitute an integral part of a project of common interest in the field of energy and transport. In addition, the CEF should allow, within each sector, the possibility to consider as eligible some synergetic elements pertaining to another sector, where such an approach improves the socioeconomic benefit of the investment. Synergies between sectors should be incentivised through the award criteria for the selection of actions, as well as through increased co-financing. (9) Regulation (EU) No 1315/2013 of the European Parliament and of the Council (7) lays down guidelines for the trans-European transport network (\u201cTEN-T\u201d) (\u201cTEN-T guidelines\u201d) that identify the infrastructure of the TEN-T, specify the requirements to be fulfilled by it and provide for measures for the implementation of the TEN-T. In particular, the TEN-T guidelines envisage the completion of the core network by 2030 through the creation of new infrastructure and the substantial upgrading and rehabilitation of existing infrastructure necessary in order to ensure network continuity. (10) In order to ensure connectivity throughout the Union, actions contributing to the development of projects of common interest in the transport sector which are financed by the CEF should build on the complementarity of all modes of transport to provide for efficient, interconnected and multimodal networks. This should include roads in those Member States where there is still a significant need for investment in order to complete their TEN-T core road network. (11) In accordance with Article 193(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (8) (\u201cthe Financial Regulation\u201d), it is possible to award a grant for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to the signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to Union\u2019s interests, it should be possible, for a limited period of time at the beginning of the MFF 2021-2027, for costs incurred in respect of actions supported under this Regulation which have already begun to be considered eligible as of 1 January 2021, even if they were incurred before the grant application was submitted. (12) In order to achieve the objectives laid down in the TEN-T guidelines, it is necessary to support, as a priority, the ongoing TEN-T projects, as well as the cross-border links and the missing links and to ensure, where applicable, that the supported actions are consistent with the corridor work plans established pursuant to Regulation (EU) No 1315/2013 and with the overall network development regarding performance and interoperability. (13) In particular, the full deployment of the European Rail Traffic Management System (\u201cERTMS\u201d) on the core network by 2030, as provided for by Regulation (EU) No 1315/2013, requires the support to be increased at Union level and the participation of private investors to be incentivised. (14) Moreover, the connection of airports to the TEN-T core network is an important precondition for successful completion of the TEN-T core network and for ensuring effective intermodality. Therefore, priority should be given to establishing such connections where they are missing. (15) For the implementation of cross-border actions, a high degree of integration with regard to planning and implementation is needed. Without prioritising any of the following examples, this integration could be demonstrated through the establishment of a single project company, a joint governance structure, a joint venture, a bilateral legal framework, a framework based on an implementing act pursuant to Article 47 of Regulation (EU) No 1315/2013, or any other form of cooperation. Establishment of integrated management structures, including joint ventures should be encouraged, including through a higher level of co-financing. (16) Streamlining measures to advance the realisation of the TEN-T, which are currently under development, should support the more efficient implementation of projects of common interest in the field of transport. (17) In order to reflect increasing transport flows and the evolution of the TEN-T, the alignment of the core network corridors and their pre-identified sections should be adapted. Such adaptations to the core network corridors should not affect the completion of the core network by 2030, should improve the corridors\u2019 coverage of the Member States\u2019 territory and should be proportionate in order to preserve the consistency and the efficiency of the corridor development and coordination. For that reason, the length of the core network corridors should not increase by more than 15 %. In due course, the alignment of the core network corridors should take into account the results of the review of the implementation of the core network provided for by Regulation (EU) No 1315/2013. The review should take into account regional cross-border rail connections on the TEN-T that have been abandoned or dismantled, as well as other changes in the comprehensive network and the impact of the United Kingdom\u2019s withdrawal from the Union. (18) It is necessary to promote public and private investments in all modes of transport in order to promote smart, interoperable, sustainable, multimodal, inclusive, accessible, safe and secure mobility throughout the Union. In its Communication of 31 May 2017 entitled \u201cEurope on the move: An agenda for a socially fair transition towards clean, competitive and connected mobility for all\u201d, the Commission presented a wide-ranging set of initiatives to make traffic safer, to encourage smart road charging, to reduce CO2 emissions, air pollution and congestion, to promote connected and autonomous mobility and to ensure proper conditions and rest times for workers. Those initiatives should be accompanied by Union financial support through the CEF, where relevant. (19) The TEN-T guidelines require, with regard to new technologies and innovation, that the TEN-T enables the decarbonisation of all modes of transport by stimulating energy efficiency and the use of alternative fuels while respecting the principle of technological neutrality. Directive 2014/94/EU of the European Parliament and of the Council (9) establishes a common framework of measures for the deployment of alternative fuels infrastructure for all modes of transport in the Union in order to reduce as far as possible the dependence on fossil fuels and to mitigate the environmental and climate impact of transport. That Directive also requires Member States to ensure that recharging or refuelling points accessible to the public are made available by 31 December 2025. As the Commission outlined in its Communication of 8 November 2017 entitled \u201cDelivering on low-emission mobility A European Union that protects the planet, empowers its consumers and defends its industry and workers\u201d, a comprehensive set of measures to promote low-emission mobility is necessary, including financial support where the market conditions do not provide a sufficient incentive. (20) In the context of its Communication of 17 May 2018 entitled \u201cSustainable Mobility for Europe: safe, connected, and clean\u201d, the Commission highlighted that automated vehicles and advanced connectivity systems will make vehicles safer, easier to share and more accessible for all citizens, including those who may be cut-off from mobility services today, such as the elderly and people with reduced mobility. In this context, the Commission also proposed an \u201cEU Strategic Action Plan on Road safety\u201d and the amendment of Directive 2008/96/EC of the European Parliament and of the Council (10). (21) In order to improve the completion of transport projects in less developed parts of the network, an allocation from the Cohesion Fund governed by Regulation (EU) 2021/1058 of the European Parliament and of the Council (11) should be transferred to the CEF to finance transport projects in the Member States eligible for financing from the Cohesion Fund. In an initial phase and within a limit of 70 % of the transferred envelope, the selection of projects eligible for financing should respect the national allocations under the Cohesion Fund. The remaining 30 % of the transferred envelope should be allocated on a competitive basis to the greatest possible number of projects located in the Member States eligible for financing from the Cohesion Fund with priority to cross-border links and missing links. Member States should be treated equally, and disadvantages resulting from permanent geographic vulnerabilities should be duly taken into account. The Commission should support Member States eligible for financing from the Cohesion Fund in their efforts to develop an appropriate series of eligible projects, in particular by strengthening the institutional capacity of the public administrations concerned. (22) In its conclusions of 21 July 2020, the European Council agreed that, in the broader context of the MFF 2021-2027, EUR 1 384 000 000 (in 2018 prices) from the CEF is to be used for the completion of missing major cross-border railway links between cohesion countries to support the functioning of the internal market and that the co-financing rules of the transfer from the Cohesion Fund to the CEF are to apply to that amount. (23) Following the Joint Communication of 10 November 2017 entitled \u201cImproving Military Mobility in the European Union\u201d, the Joint Communication of 28 March 2018 on Action Plan on Military Mobility highlighted that transport infrastructure policy offers a clear opportunity to increase synergies between defence needs and the TEN-T with the overall aim of improving military mobility across the Union, taking into account geographical balance and the potential benefits for civil protection. In 2018, in accordance with the Action Plan on Military Mobility, the Council considered and validated the military requirements in relation to transport infrastructure and, in 2019, the Commission services identified the parts of the TEN-T which are suitable for dual use, including necessary upgrades of existing infrastructure. Union funding for the dual-use projects should be implemented through the CEF on the basis of work programmes, taking into account the applicable requirements established in the context of the Action Plan on Military Mobility and any further indicative list of priority projects that are identified by Member States in accordance with that Plan. (24) The TEN-T guidelines recognise that the comprehensive network ensures the accessibility and connectivity of all islands and regions in the Union, including remote and outermost regions. Furthermore, in its Communication of 24 October 2017 entitled \u201cA stronger and renewed strategic partnership with the EU\u2019s outermost regions\u201d, the Commission highlighted the outermost regions\u2019 specific transport, energy and digital needs and the necessity to provide adequate Union funding to match those needs, including through the CEF by applying co-financing rates up to a maximum of 70 %. (25) Considering the significant investment needs to be met in order to make progress towards completing the TEN-T core network by 2030 (estimated at EUR 350 billion during 2021-2027), completing the TEN-T comprehensive network by 2050 and decarbonisation-digitalisation-urban investments (estimated at EUR 700 billion during 2021-2027), it is appropriate to make the most efficient use of the various Union financing programmes and instruments, thereby maximising the added value of investments supported by the Union. This would be achieved via a streamlined investment process, enhancing visibility on the transport pipeline and consistency across relevant Union programmes, notably the CEF, the European Regional Development Fund (ERDF), the Cohesion Fund and the InvestEU Programme. In particular, the enabling conditions as detailed under Annex IV of Regulation (EU) 2021/1060 should be taken into account, where relevant. (26) Regulation (EU) No 347/2013 of the European Parliament and of the Council (12) identifies the trans-European energy infrastructure priorities which need to be implemented in order to meet the Union\u2019s energy and climate policy objectives, identifies projects of common interest necessary to implement those priorities and lays down measures concerning the granting of permits, public involvement and regulation to speed up and/or facilitate the implementation of those projects, including criteria for the eligibility of such projects for Union financial support. The identification of projects of common interest in accordance with that Regulation will continue to follow the \u201cenergy efficiency first\u201d principle, with projects being assessed against energy demand scenarios that are fully consistent with Union energy and climate targets. (27) Directive (EU) 2018/2001 of the European Parliament and of the Council (13) stresses the need to set up an enabling framework comprising the enhanced use of Union funds, with explicit reference to enabling actions to support cross-border cooperation in the field of renewable energy. (28) While completion of network infrastructure remains the priority in order to achieve the development of renewable energy, integrating cross-border cooperation on renewable energy and developing a smart and efficient energy system that includes storage and demand response solutions that help balance the grid reflects the approach adopted under the Clean Energy for all Europeans package, with collective responsibility to reach an ambitious target for renewable energy in 2030, and the changed policy context, ensuring a fair and adequate transition, with ambitious long-term decarbonisation objectives. (29) Innovative infrastructure technologies that enable the transition to low emission energy and mobility systems and that improve security of supply, while seeking greater energy independence for the Union, are essential in view of the Union\u2019s decarbonisation agenda. In particular, in its Communication of 23 November 2017 entitled \u201cStrengthening Europe\u2019s energy networks\u201d, the Commission emphasised that, given that renewable energy is to constitute half of the electricity generation by 2030, the role of electricity will increasingly be to drive the decarbonisation of sectors which have so far been dominated by fossil fuels, such as transport, industry and heating and cooling, and that accordingly the focus under the trans-European energy infrastructure policy must be on electricity interconnections, electricity storages, smart grids projects and gas infrastructure investments. To support the Union\u2019s decarbonisation objectives, internal market integration and security of supply, due consideration and priority should be given to technologies and projects which contribute to the transition to a low emission economy. The Commission will aim to increase the number of cross-border smart grid and innovative storage, as well as CO2 transport projects to be supported under the CEF. (30) Cross-border projects in the field of renewable energy are to enable the cost-effective deployment of renewable energy in the Union and the achievement of the Union\u2019s binding target of at least 32 % renewable energy in 2030 as referred to in Article 3 of Directive (EU) 2018/2001, and are to contribute to the strategic uptake of innovative technologies concerning renewable energy. Illustrative examples of eligible technologies include the generation of renewable energy from on- and offshore wind, solar energy, sustainable biomass, ocean energy, geothermal energy or combinations thereof, their connection to the grid and additional elements such as storage or conversion facilities. Eligible action is not limited to the electricity sector and can cover other energy carriers and potential sector coupling with, for example, heating and cooling, power-to-gas, storage and transport. This list is non-exhaustive in order to keep flexibility with regard to technological advances and developments. Such projects do not necessarily entail a physical link between the cooperating Member States. Those projects can be located on the territory of only one of the Member States involved, provided that the general criteria of Part IV of the Annex to this Regulation apply. (31) In order to support cross-border cooperation in the area of renewable energy and the market uptake of projects, the Commission should facilitate the development of cross-border projects in the field of renewable energy. In the energy sector, in the absence of sufficient market uptake of cross-border projects in the field of renewable energy, unused budget envisaged for cross-border projects in the field of renewable energy should be used to meet the objectives of the trans-European energy networks for actions relating to projects of common interest as set out in Regulation (EU) No 347/2013, before considering a possible use for the Union renewable energy financing mechanism established in Regulation (EU) 2018/1999 of the European Parliament and of the Council (14). (32) It is necessary to support smart grid projects that integrate electricity generation, distribution or consumption using real time system management and influencing cross-border energy flows. Support from the CEF for such projects should also reflect the central role of smart grids in the energy transition and should help to overcome funding gaps that are currently hampering investment in the large-scale deployment of smart grid technology. (33) In the context of Union support, special consideration should be given to cross-border energy interconnections, including those necessary to reach the 10 % electricity interconnection target for 2020 and the 15 % target for 2030 established by Regulation (EU) 2018/1999. The deployment of electricity interconnectors is crucial for integrating markets and ending energy isolation by allowing more renewable energy into the system and thereby benefiting from their different demand and renewable supply portfolio, as well as from off-shore wind networks and smart grids, and integrating all countries into a liquid and competitive energy market. (34) The achievement of the Digital Single Market relies on the underlying digital connectivity infrastructure. The digitalisation of Union industry and the modernisation of sectors like transport, energy, healthcare and public administration depend on universal access to reliable, affordable, high and very high capacity networks. Digital connectivity has become one of the decisive factors in closing economic, social and territorial divides, supporting the modernisation of local economies and underpinning the diversification of economic activities. The scope of the intervention of the CEF in the area of digital connectivity infrastructure should be adjusted to reflect its increasing importance for the economy and for society at large. Therefore, it is necessary to set out the digital connectivity infrastructure projects of common interest needed to meet the Union\u2019s Digital Single Market objectives and to repeal Regulation (EU) No 283/2014 of the European Parliament and of the Council (15). (35) In its Communication of 14 September 2016 entitled \u201cConnectivity for a Competitive Digital Single Market \u2013 Towards a European Gigabit Society\u201d (the \u201cGigabit Society Strategy\u201d), the Commission sets out strategic objectives for 2025 with a view to optimising investment in digital connectivity infrastructure. Directive (EU) 2018/1972 of the European Parliament and of the Council (16) aims, inter alia, to create a regulatory environment which incentivises private investments in digital connectivity networks. It is nevertheless clear that network deployments will remain commercially non-viable in many areas throughout the Union due to various factors such as remoteness and territorial or geographical specificities and low population density and to various socioeconomic factors, and therefore urgently require closer attention. The CEF should therefore be adjusted to contribute to the achievement of those strategic objectives in the Gigabit Society Strategy which aim to contribute to a balance between rural and urban developments, and to complement the support provided for the deployment of very high capacity networks by other programmes, in particular the ERDF, Cohesion Fund and the InvestEU Programme. (36) While all digital connectivity networks that are connected to the internet are intrinsically trans-European, which is due mainly to the functioning of the applications and services which they enable, priority for support via the CEF should be given to actions with the highest expected impact on the Digital Single Market, inter alia, through their alignment with the objectives of the Gigabit Society Strategy, as well as on the digital transformation of the economy and society, having regard to market failures and implementation obstacles observed. (37) Schools, universities, libraries, local, regional or national administrations, main providers of public services, hospitals and medical centres, transport hubs and digitally intensive enterprises are entities and places that can influence important socioeconomic developments in the areas in which they are located, including rural and sparsely populated areas. Such socioeconomic drivers need to be at the cutting edge of Gigabit connectivity in order to provide access to the best services and applications for households, businesses and local communities in the Union. The CEF should support access to very high capacity networks, including 5G systems and other state-of-the-art connectivity capable of providing Gigabit connectivity for those socioeconomic drivers with a view to maximising their positive effects on the wider economy and society within their areas, including by generating wider user demand for connectivity and services. (38) Unconnected territories throughout the Union represent bottlenecks and unexploited potential for the Digital Single Market. In most rural and remote areas, high-quality internet connectivity can play an essential role in preventing digital divide, isolation and depopulation by reducing the costs of delivery of both goods and services and in partially compensating for remoteness. High-quality internet connectivity is necessary for new economic opportunities such as precision farming or the development of a bio-economy in rural areas. The CEF should contribute to providing all households in the Union, whether rural or urban, with very high-capacity fixed or wireless connectivity, focusing on those deployments in respect of which a degree of market failure is observed that can be addressed using low intensity grants. The synergies of actions supported by the CEF should be maximised, giving due regard to the level of concentration of socioeconomic drivers in a given area and to the level of funding needed to generate coverage. Moreover, the CEF should aim to achieve comprehensive coverage of households and territories, as it is uneconomic at a later stage to address gaps in an area that has already been covered. (39) In addition, building on the success of the WiFi4EU initiative, the CEF should continue to support the provision of free, secure, high-quality, local wireless connectivity in centres of local public life, including entities with a public mission such as public authorities and providers of public services, as well as outdoor spaces accessible to the general public, in order to promote the Union\u2019s digital vision in local communities. (40) Digital infrastructure is an important springboard for innovation. In order to maximise its impact, the CEF should focus on funding the digital infrastructure. Individual digital services and applications, such as those involving various distributed ledger technologies or applying artificial intelligence, should therefore be outside the scope of the CEF and instead be addressed through other instruments such as the Digital Europe Programme, established by Regulation (EU) 2021/694 of the European Parliament and of the Council (17), as appropriate. It is also important to maximise the synergies between different programmes. (41) The viability of the anticipated next generation of digital services, such as \u2018Internet of Things\u2019 services, and digital applications, which are expected to bring significant benefits across various sectors and for society as a whole, will require uninterrupted cross-border coverage with 5G systems, in particular to allow users and objects to remain connected while on the move. However, the cost sharing scenarios for 5G deployment across those sectors remain unclear and the perceived risks of commercial deployment in some key areas are very high. Road corridors and train connections are expected to be key areas for the first phase of new applications in the area of connected mobility and therefore constitute vital cross-border projects for funding under the CEF. (42) The deployment of backbone electronic communications networks, including submarine cables connecting European territories to third countries on other continents or connecting European islands, outermost regions or overseas countries and territories, including via Union territorial waters and the exclusive economic zones of the Member States, is needed in order to provide necessary redundancy for such vital infrastructure, to increase the capacity and resilience of the Union\u2019s digital networks and to contribute to territorial cohesion. However, such projects are often commercially non-viable without public support. In addition, support should be available to complement European high-performance computing resources with adequate terabit-capacity connections. (43) Actions contributing to projects of common interest in the area of digital connectivity infrastructure should deploy the best available and best suited technology for the specific project, which offers the best balance between state-of-the-art technologies in terms of data flow capacity, transmission security, network resilience and cost efficiency. Such deployments should be prioritised by way of work programmes, taking into account the criteria set out in this Regulation. Deployments of very high capacity networks can include passive infrastructure, with a view to maximise socioeconomic as well as environmental benefits. Finally, when prioritising actions, the potential positive spill-overs in terms of connectivity should be taken into account, for example when a project deployed can improve the business case for future deployments leading to further coverage of territories and population in areas which have remained uncovered so far. (44) The Union has developed its own satellite Positioning, Navigation and Timing (PNT) technology (the Galileo and EGNOS programmes) and its own Earth observation and monitoring programme (Copernicus). Galileo and EGNOS programmes and the Copernicus programme offer advanced services which provide important economic benefits to public and private users. Therefore, any transport, energy or digital infrastructure funded by the CEF, that makes use of PNT or Earth observations services, should be technically compatible with those programmes. (45) The positive results of the first blending call for proposals launched under the current programme in 2017 confirmed the relevance and added value of using Union grants for blending with financing from the European Investment Bank or National Promotional Banks or other development and public financial institutions, as well as from private-sector finance institutions and private-sector investors, including through public private partnerships. Blending should contribute to attracting private investment and to providing leverage of the overall public sector contribution, in line with the goals of the InvestEU Programme. The CEF should therefore continue to support actions that can be financed by a combination of Union grants and other sources of financing. (46) In the transport sector, the amounts used for blending operations should not exceed 10 % of the amount from Heading 1(2) of the MFF 2021-2027. It should be possible to use blending operations, for instance, for actions relating to smart, interoperable, sustainable, inclusive, accessible, safe and secure mobility. (47) The policy objectives of the CEF are also to be addressed through financial instruments and budgetary guarantee under the policy windows of the InvestEU Programme. The CEF actions should be used to boost investment by addressing market failures or sub-optimal investment situations, in a proportionate manner, without duplicating or crowding out private financing, in particular where actions are not commercially viable but where they have a clear Union added value. (48) In order to favour the integrated development of the innovation cycle, it is necessary to ensure complementarity between the innovative solutions developed in the context of the Union research and innovation framework programmes and the innovative solutions deployed with support from the CEF. For this purpose, synergies with the Horizon Europe Programme, established by Regulation (EU) 2021/695 of the European Parliament and of the Council (18), are to ensure that research and innovation needs in the transport, energy and digital sectors within the Union are identified and established during Horizon Europe\u2019s strategic planning process. Moreover, synergies with Horizon Europe are to ensure that the CEF supports large-scale roll-out and deployment of innovative technologies and solutions in the fields of transport, energy and digital infrastructure, in particular those resulting from Horizon Europe. Furthermore, synergies with Horizon Europe are to ensure that the exchange of information and data between Horizon Europe and the CEF will be facilitated, for example by highlighting technologies from Horizon Europe with a high market readiness that could be further deployed through the CEF. (49) The duration of the CEF should be aligned to the duration of the MFF. This Regulation should lay down a financial envelope for the entire period 2021-2027 which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (19) for the European Parliament and the Council during the annual budgetary procedure. (50) At Union level, the European Semester of economic policy coordination is the framework within which national reform priorities are identified and their implementation monitored. Member States develop their own national multiannual investment strategies in support of those reform priorities. Those strategies should be presented alongside the yearly National Reform Programmes as a way to outline and coordinate priority investment projects to be supported by national or Union funding, or both. They should also serve to use Union funding in a coherent manner and to maximise the added value of the financial support to be received notably from the ERDF and Cohesion Fund, the European Investment Stabilisation Function, InvestEU Programme and the CEF, where relevant. Financial support should also be used in a manner consistent with Union and national energy and climate plans, where relevant. (51) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, prizes, procurement and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (52) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden and the expected risk of non-compliance. When making such choices, consideration should be given to the use of lump sums, of flat rates and of unit costs, as well as of financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (53) Legal entities established in the Union should as far as possible be able to participate on a reciprocal basis in equivalent programmes of third countries that participate in the CEF. (54) Third countries which are members of the European Economic Area (EEA) may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (20) (the \u201cEEA Agreement\u201d), which provides for the implementation of the programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required to enable the authorising officer responsible, the European Anti-Fraud Office (OLAF) and the Court of Auditors to comprehensively exercise their respective competences. (55) The Financial Regulation establishes the rules concerning the award of grants. In order to take into account the specificity of the actions supported by the CEF and to ensure consistent implementation among the sectors covered by the CEF, it is necessary to provide additional indications as regards the eligibility and award criteria. The selection of operations and their financing should only be subject to the conditions provided for in this Regulation and the Financial Regulation. Without prejudice to the Financial Regulation, it should be possible for the work programmes to provide for simplified procedures. (56) In accordance with the Financial Regulation, selection and award criteria are established in the work programmes. In the transport sector, the quality and relevance of a project should also be assessed taking into account the project\u2019s expected impact on European connectivity, its compliance with accessibility requirements and its strategy as regards future maintenance needs. (57) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (21) and Council Regulations (EC, Euratom) No 2988/95 (22), (Euratom, EC) No 2185/96 (23) and (EU) 2017/1939 (24), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, OLAF has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (25). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (58) Pursuant to Council Decision 2013/755/EU (26) persons and entities established in overseas countries and Territories (OCTs) are eligible for funding subject to the rules and objectives of the CEF and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (59) The Union should seek coherence and synergies with the Union programmes for external policies, including pre-accession assistance following the engagements undertaken in the context of the Commission Communication of 6 February 2018 entitled \u201cA credible enlargement perspective for and enhanced EU engagement with the Western Balkans\u201d. (60) When third countries or entities established in third countries participate in actions contributing to projects of common interest or to cross-border projects in the field of renewable energy, financial support should only be available if it is indispensable to the achievement of the objectives of those projects. With regard to cross-border projects in the field of renewable energy, cooperation between one or more Member States and a third country (including within the Energy Community) should respect the conditions set out in Directive (EU) 2018/2001 on the need for a physical link to the Union. (61) In its Communication of 3 October 2017 entitled \u2018Making Public Procurement work in and for Europe\u2019, the Commission notes that the Union is the world\u2019s most open market for procurement, but that other countries do not always reciprocate by granting access to Union companies to their markets for procurement. Beneficiaries of the CEF should therefore make full use of the strategic procurement possibilities offered by Directive 2014/25/EU of the European Parliament and of the Council (27). (62) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (28), the CEF should be evaluated on the basis of information collected in accordance with specific monitoring requirements, such as on climate tracking, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the CEF on the ground. Evaluations should be carried out by the Commission and communicated to the European Parliament, the Council, the European Economic and Social Committee and the Committee of Regions in order to assess the effectiveness and efficiency of the funding and its impact on the overall goals of the CEF and make any adjustments necessary. (63) Transparent, accountable and adequate monitoring and reporting measures, including measurable indicators, should be implemented in order to assess and report on the progress of the CEF towards the achievement of the general and specific objectives set out in this Regulation. Those measures should also ensure that the achievements of the CEF are recognised. This performance reporting system should ensure that data for monitoring the implementation of the CEF and its results are suitable for an in-depth analysis of the progress achieved and of the difficulties encountered and that those data and results are collected efficiently, effectively and in a timely manner. It is necessary to impose proportionate reporting requirements on recipients of Union funds in order to collect relevant data for the CEF. (64) The CEF should be implemented through work programmes. By 15 October 2021, the Commission should adopt the first multiannual work programmes, which should include the timetable of the calls for proposals for the first three years of the CEF, their topics and indicative budget, as well as a prospective framework covering the entire programming period. (65) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the laying down of specific rules on co-funding between the parts on cross-border projects in the field of renewable energy; the specifying, where necessary, of the infrastructure requirements applicable to certain categories of dual-use infrastructure actions and the evaluation procedure regarding the actions connected with dual-use infrastructure actions; the adoption of work programmes; and the granting of Union financial support. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (29). (66) In order to adapt, where necessary, the indicators used for the monitoring of the CEF, the indicative percentages of budgetary resources allocated to each specific objective in the transport sector and the definition of the transport core network corridors, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to Parts I, II and III of the Annex to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (67) Since the objectives of this Regulation, namely to build, develop, modernise and complete the trans-European networks in the transport, energy and digital sectors and to facilitate cross-border cooperation in the field of renewable energy, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (68) Regulation (EU) No 1316/2013 of the European Parliament and of the Council (30) and Regulation (EU) No 283/2014 should therefore be repealed. However, the effects of Article 29 of Regulation (EU) No 1316/2013, which amends the Annex to Regulation (EU) No 913/2010 of the European Parliament and of the Council (31) as regards the list of freight corridors, should be maintained. (69) In order to ensure continuity in providing support in the relevant policy areas and to allow implementation to start from the beginning of the MFF 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the Connecting Europe Facility (the \u2018CEF\u2019) for the period of the Multiannual Financial Framework (the \u201cMFF\u201d) 2021-2027. This Regulation lays down the objectives of the CEF, its budget for the period 2021-2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (a) \u201caction\u201d means any activity which has been identified as financially and technically independent, has a set time-frame and is necessary for the implementation of a project; (b) \u201calternative fuels\u201d means alternative fuels for all modes of transport as defined in Article 2, point (1), of Directive 2014/94/EU; (c) \u201cbeneficiary\u201d means an entity with legal personality with which a grant agreement has been signed; (d) \u201cblending operation\u201d means actions supported by the Union budget, including within blending facilities pursuant to Article 2, point (6), of the Financial Regulation combining non-repayable forms of support and/or financial instruments and/or budgetary guarantees from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; (e) \u201ccomprehensive network\u201d means the transport infrastructure identified in accordance with Chapter II of Regulation (EU) No 1315/2013; (f) \u201ccore network\u201d means the transport infrastructure identified in accordance with Chapter III of Regulation (EU) No 1315/2013; (g) \u201ccore network corridors\u201d means instruments to facilitate the coordinated implementation of the core network as provided for in Chapter IV of Regulation (EU) No 1315/2013 and listed in Part III of the Annex to this Regulation; (h) \u201ccross border link\u201d means, in the transport sector, a project of common interest which ensures the continuity of the TEN-T between Member States or between a Member State and a third country; (i) \u201cmissing link\u201d means an all modes of transport missing section of the TEN-T or a transport section that is providing the connection of core or comprehensive networks with the TEN-T corridors which hampers the continuity of the TEN-T or containing one or more bottlenecks affecting the continuity of the TEN-T; (j) \u201cdual-use infrastructure\u201d means a transport network infrastructure that addresses both civilian and defence needs; (k) \u201ccross-border project in the field of renewable energy\u201d means a project selected or eligible to be selected under a cooperation agreement or any other kind of arrangement between two or more Member States or arrangements between one or more Member States and one or more third countries as set out in Articles 8, 9, 11 and 13 of Directive (EU) 2018/2001 in the planning or deployment of renewable energy, in accordance with the criteria set out in Part IV of the Annex to this Regulation; (l) \u201cenergy efficiency first\u201d means energy efficiency first as defined in Article 2, point (18), of Regulation (EU) 2018/1999; (m) \u201cdigital connectivity infrastructure\u201d means very high capacity networks, 5G systems, very high-quality local wireless connectivity and backbone networks, as well as operational digital platforms directly associated with transport and energy infrastructure; (n) \u201c5G systems\u201d means a set of digital infrastructure elements based on globally agreed standards for mobile and wireless communications technology used for connectivity and added-value services with advanced performance characteristics such as very high data rates and capacity, low latency communications, ultra-high reliability or support for a high number of connected devices; (o) \u201c5G corridor\u201d means a transport path, road, railway or inland waterway, fully covered with digital connectivity infrastructure and in particular 5G systems, enabling the uninterrupted provision of synergy digital services such as connected and automated mobility, similar smart mobility services for railways or digital connectivity on inland waterways; (p) \u201coperational digital platforms directly associated with transport and energy infrastructure\u201d means physical and virtual information communication technology resources, operating via the communication infrastructure, which support the flow, storage, processing and analysis of transport or energy infrastructure data, or both; (q) \u201cproject of common interest\u201d means a project identified in Regulation (EU) No 1315/2013 or Regulation (EU) No 347/2013 or in Article 8 of this Regulation; (r) \u201cstudies\u201d means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package; (s) \u201csocioeconomic drivers\u201d means entities which by their mission, nature or location can directly or indirectly generate important socioeconomic benefits for citizens, business and local communities located in their surrounding territory, or in their area of influence; (t) \u201cthird country\u201d means a country that is not a Member State of the Union; (u) \u201cvery high capacity networks\u201d means very high capacity networks as defined in Article 2, point (2), of Directive (EU) 2018/1972; (v) \u201cworks\u201d means the purchase, supply and deployment of components, systems and services including software, the carrying-out of development and construction and installation activities relating to a project, the acceptance of installations and the launching of a project. Article 3 Objectives 1. The general objectives of the CEF are to build, develop, modernise and complete the trans-European networks in the transport, energy and digital sectors and to facilitate cross-border cooperation in the field of renewable energy, taking into account the long-term decarbonisation commitments and the goals of increasing European competitiveness; smart, sustainable and inclusive growth; territorial, social and economic cohesion; and the access to and integration of the internal market, with an emphasis on facilitating the synergies among the transport, energy and digital sectors. 2. The specific objectives of the CEF are: (a) in the transport sector: (i) to contribute to the development of projects of common interest relating to efficient, interconnected and multimodal networks and infrastructure for smart, interoperable, sustainable, inclusive, accessible, safe and secure mobility in accordance with the objectives of Regulation (EU) No 1315/2013; and (ii) to adapt parts of the TEN-T for the dual use of the transport infrastructure with a view to improving both civilian and military mobility; (b) in the energy sector: (i) to contribute to the development of projects of common interest relating to further integration of an efficient and competitive internal energy market, interoperability of networks across borders and sectors, facilitating decarbonisation of the economy, promoting energy efficiency and ensuring security of supply; and (ii) to facilitate cross-border cooperation in the area of energy, including renewable energy; (c) in the digital sector: to contribute to the development of projects of common interest relating to the deployment of and access to safe and secure very high capacity networks, including 5G systems, and to the increased resilience and capacity of digital backbone networks on Union territories by linking them to neighbouring territories, as well as to the digitalisation of transport and energy networks. Article 4 Budget 1. The financial envelope for the implementation of the CEF for the period from 1 January 2021 to 31 December 2027 shall be EUR 33 710 000 000 (32) in current prices. In line with the Union objective of mainstreaming climate actions into Union sectoral policies and Union funds, the CEF shall contribute, through its actions, 60 % of its overall financial envelope to climate objectives. 2. The distribution of the amount referred to in paragraph 1 shall be as follows: (a) EUR 25 807 000 000 for the specific objectives referred to in Article 3(2), point (a), of which: (i) EUR 12 830 000 000 from the MFF 2021-2027, Heading 1(2), European Strategic Investment; (ii) EUR 11 286 000 000 transferred from the Cohesion Fund to be spent in line with this Regulation exclusively in Member States eligible for funding from the Cohesion Fund; (iii) EUR 1 691 000 000 from the MFF 2021-2027, Heading 5(13), for the specific objective referred to in Article 3(2), point (a)(ii); (b) EUR 5 838 000 000 for the specific objectives referred to in Article 3(2), point (b), of which 15 %, subject to market uptake, for cross-border projects in the field of renewable energy, and if the 15 % threshold is reached, the Commission shall increase that threshold up to 20 %, subject to market uptake; (c) EUR 2 065 000 000 for the specific objectives referred to in Article 3(2), point (c). 3. The Commission shall not depart from the amount referred to in paragraph 2, point (a)(ii). 4. Up to 1 % of the amount referred to in paragraph 1 may be used to finance technical and administrative assistance for the implementation of the CEF and the sector-specific guidelines, such as preparatory, monitoring, control, audit and evaluation activities including corporate information and technology systems. That amount may also be used to finance accompanying measures to support the preparation of projects, and in particular to provide advisory services to project promoters concerning funding opportunities in order to assist them in the structuring of their project finance. 5. Budgetary commitments for actions extending over more than one financial year may be broken down into annual instalments, over two or more years. 6. In accordance with Article 193(2), second subparagraph, point (a), of the Financial Regulation, taking into account the delayed entry into force of this Regulation and in order to ensure continuity, for a limited period, costs incurred in respect of actions supported under this Regulation may be considered eligible as of 1 January 2021, even if they were incurred before the grant application was submitted. 7. The amount transferred from the Cohesion Fund shall be implemented in accordance with this Regulation, subject to paragraph 8 of this Article and without prejudice to Article 15(2), point (c). 8. As regards the amounts transferred from the Cohesion Fund, 30 % of those amounts shall be made available, immediately on a competitive basis, to all Member States eligible for funding from the Cohesion Fund to finance transport infrastructure projects in accordance with this Regulation, with priority being given to supporting the greatest possible number of cross-border and missing links. Until 31 December 2023, the selection of projects eligible for financing shall respect the national allocations under the Cohesion Fund with regard to 70 % of the resources transferred. As of 1 January 2024, resources transferred to the CEF which have not been committed to a transport infrastructure project shall be made available to all Member States eligible for funding from the Cohesion Fund to finance transport infrastructure projects in accordance with this Regulation. 9. In respect of Member States whose gross national income (GNI) per capita, measured in purchasing power standards (PPS) for the period 2015-2017, is less than 60 % of the average GNI per capita of the EU-27, 70 % of 70 % of the amount that those Member States have transferred to the CEF shall be guaranteed until 31 December 2024. 10. Until 31 December 2025, the total amount allocated from the amount referred to in paragraph 2, point (a)(ii), to actions in a Member State eligible for funding from the Cohesion Fund shall not exceed 170 % of the share of that Member State in the total amount transferred from the Cohesion Fund. 11. In order to support Member States which are eligible for funding from the Cohesion Fund and which might experience difficulties in designing projects that are of a sufficient maturity, quality, or both, and that have sufficient Union added value, particular attention shall be given to technical assistance which aims to strengthen the institutional capacity and the efficiency of public administrations and public services in relation to the development and implementation of projects listed in this Regulation. The Commission shall do its utmost to enable Member States eligible for funding from the Cohesion Fund to attain, by the end of the period 2021-2027, the highest possible absorption of the amount transferred to the CEF, including through the organisation of additional calls. In addition, particular attention and support shall be given to those Member States whose GNI per capita, measured in PPS for the period 2015-2017, is less than 60 % of the average GNI per capita of the EU-27. 12. The amount transferred from the Cohesion Fund shall not be used to finance cross-sectoral work programmes and blending operations. 13. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the CEF, subject to the conditions set out in Article 21 of Regulation (EU) 2021/1060. The Commission shall implement those resources directly in accordance with Article 62(1), first subparagraph, point (a), of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. 14. Without prejudice to paragraph 13 of this Article, in the digital sector, resources allocated to Member States under shared management may, at the request of those Member States, be transferred to the CEF, including for the purpose of complementing the funding of eligible actions under Article 9(4) of this Regulation, up to 100 % of the total eligible cost, without prejudice to the co-financing principle laid down in Article 190 of the Financial Regulation and to the State Aid Rules. Those resources shall be used for the benefit of the Member State concerned only. Article 5 Third countries associated to the CEF 1. The CEF shall be open to the participation of the following third countries: (a) members of the European Free Trade Association which are members of the EEA, in accordance with the conditions laid down in the EEA Agreement; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country any decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests; (v) provides for reciprocity in accessing similar programmes in the third country participating in the Union programmes. The contributions referred to in the first subparagraph, point (d)(ii), of this Article shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. 2. Without prejudice to Article 8 of Regulation (EU) No 1315/2013, the third countries referred to in paragraph 1 of this Article, and entities established in those countries, may not receive financial assistance under this Regulation except where it is indispensable to the achievement of the objectives of a given project of common interest or a project in accordance with Article 7(1) of this Regulation and under the conditions set in the work programmes referred to in Article 20 of this Regulation. Article 6 Implementation and forms of Union funding 1. The CEF shall be implemented in direct management in accordance with the Financial Regulation or in indirect management by bodies referred to in Article 62(1), first subparagraph, point (c), of the Financial Regulation. 2. The CEF may provide funding in the forms of grants and procurement as laid down in the Financial Regulation. It may also contribute to blending operations in accordance with the Regulation (EU) 2021/523 of the European Parliament and of the Council (33) and Title X of the Financial Regulation. The Union contribution to blending operations in the transport sector shall not exceed 10 % of the budgetary amount indicated in Article 4(2), point (a)(i), of this Regulation. In the transport sector, blending operations may be used for actions relating to smart, interoperable, sustainable, inclusive, accessible, safe and secure mobility as referred to in Article 9(2), point (b), of this Regulation. 3. The Commission may delegate power to implement part of the CEF to executive agencies in accordance with Article 69 of the Financial Regulation, with a view to fulfilling the optimum management and efficiency requirements of the CEF in the transport, energy and digital sectors. 4. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and shall be considered to be a sufficient guarantee under the Financial Regulation. Article 33(7) of Regulation (EU) 2021/695 shall apply. Article 7 Cross-border projects in the field of renewable energy 1. Cross-border projects in the field of renewable energy shall contribute to decarbonisation, to completing the internal energy market and to enhancing the security of supply. Those projects shall be included in a cooperation agreement or in any other kind of arrangement between two or more Member States or arrangements between one or more Member States and one or more third countries as set out in Articles 8, 9, 11 and 13 of Directive (EU) 2018/2001. Those projects shall meet the objectives, the general criteria and the procedure laid down in Part IV of the Annex to this Regulation. 2. By 31 December 2021, the Commission shall adopt delegated acts in accordance with Article 26 laying down, without prejudice to the award criteria set out in Article 14, specific selection criteria and the details of the process for selecting the projects. The Commission shall publish the methodologies for assessing the contribution of the project to the general criteria and for producing the cost-benefit analysis specified in Part IV of the Annex. 3. Studies that aim to develop and identify cross-border projects in the field of renewable energy shall be eligible for funding under this Regulation. 4. Cross-border projects in the field of renewable energy are eligible for Union funding for works if they meet the following additional criteria: (a) the project specific cost-benefit analysis pursuant to Part IV, point 3, of the Annex is compulsory for all supported projects and takes into account any revenues resulting from support schemes, has been performed in a transparent, comprehensive and complete manner and provides evidence concerning the existence of significant cost savings or benefits, or both, in terms of system integration, environmental sustainability, security of supply or innovation; and (b) the applicant demonstrates that the project would not materialise in the absence of the grant or that the project cannot be commercially viable in the absence of the grant. 5. The amount of the grant for works shall: (a) be proportionate to the cost savings or benefits referred to in Part IV, point 2(b), of the Annex, or both; (b) not exceed the amount required to ensure that the project materialises or becomes commercially viable; and (c) comply with Article 15(3). 6. The CEF shall provide for the possibility of coordinated funding with the enabling framework for renewable energy deployment referred to in Article 3(5) of Directive (EU) 2018/2001 and co-funding with the Union renewable energy financing mechanism referred to in Article 33 of Regulation (EU) 2018/1999. 7. The Commission shall regularly assess the uptake of funds for cross-border projects in the field of renewable energy against the reference amount set out in Article 4(2), point (b), of this Regulation. Following that assessment, in the absence of sufficient market uptake of funds for cross-border projects in the field of renewable energy, the unused budget envisaged for those projects shall be used to meet the objectives of the trans-European energy networks set out in Article 3(2), point (b)(i), of this Regulation for eligible actions referred in Article 9(3) point (a), of this Regulation and, from 2024, may also be used to co-fund the Union renewable energy financing mechanism established under Regulation (EU) 2018/1999. 8. The Commission shall adopt an implementing act, laying down specific rules on co-funding between the parts on cross-border projects in the field of renewable energy under the CEF and the Union renewable energy financing mechanism established under Article 33 of Regulation (EU) 2018/1999. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24(2) of this Regulation. Article 8 Projects of common interest in the area of digital connectivity infrastructure 1. Projects of common interest in the area of digital connectivity infrastructure are those projects that make an important contribution to the Union\u2019s strategic connectivity objectives and/or provide the network infrastructure supporting the digital transformation of the economy and society, as well as the Union\u2019s Digital Single Market. 2. Projects of common interest in the area of digital connectivity infrastructure shall meet the following criteria: (a) the project contributes to the specific objective provided for in Article 3(2), point (c); and (b) the project deploys the best available and best suited technology for that specific project, which proposes the best balance in terms of data flow capacity, transmission security, network resilience, cyber security and cost efficiency. 3. Studies that aim to develop and identify projects of common interest in the area of digital connectivity infrastructure shall be eligible for funding under this Regulation. 4. Without prejudice to the award criteria laid down in Article 14, priority for funding shall be determined taking into account the following criteria: (a) actions contributing to deployment of and access to very high capacity networks, including 5G systems and other state-of-the-art connectivity, in accordance with Union strategic connectivity targets in areas where socioeconomic drivers are located shall be prioritised, taking into account the connectivity needs of those areas and the additional area coverage generated, including for households, in accordance with Part V, point 1, of the Annex; stand-alone deployments to socioeconomic drivers shall be eligible for funding, provided that those deployments are economically proportionate and physically practicable; (b) actions contributing to the provision of very high-quality local wireless connectivity in local communities shall be prioritised in accordance with Part V, point 2, of the Annex; (c) actions contributing to the deployment of 5G corridors along major transport paths, including on the TEN-T, such as those listed in Part V, point 3, of the Annex, shall be prioritised to ensure coverage along those major transport paths, enabling the uninterrupted provision of synergy digital services, taking into account its socioeconomic relevance relative to any currently installed technological solutions in a forward looking approach; (d) projects of common interest which aim to deploy or significantly upgrade cross-border backbone networks linking the Union to third countries and to reinforce links between electronic communications networks within the Union territory, including submarine cables, shall be prioritised according to the extent to which they significantly contribute to the increased performance, resilience and very high capacity of those electronic communications networks; (e) projects of common interest deploying operational digital platforms shall prioritise actions based on state-of-the-art technologies, taking into account aspects such as interoperability, cybersecurity, data privacy and re-use. CHAPTER II ELIGIBILITY Article 9 Eligible actions 1. Only actions which contribute to the achievement of the objectives referred to in Article 3, whilst taking into account long-term decarbonisation commitments, shall be eligible for funding. Such actions include studies, works and other accompanying measures necessary for the management and implementation of the CEF and the sector-specific guidelines. Studies shall be eligible only if they relate to projects eligible under the CEF. 2. In the transport sector, only the following actions shall be eligible to receive Union financial support under this Regulation: (a) actions relating to efficient, interconnected, interoperable and multimodal networks for the development of railway, road, inland waterway and maritime infrastructure: (i) actions implementing the core network in accordance with Chapter III of Regulation (EU) No 1315/2013, including actions relating to cross-border links and missing links, such as those listed in Part III of the Annex to this Regulation, as well as urban nodes, multimodal logistics platforms, maritime ports, inland ports, rail-road terminals and connections to airports of the core network as defined in Annex II to Regulation (EU) No 1315/2013; actions implementing the core network may include related elements located on the comprehensive network when necessary to optimise the investment and according to modalities specified in the work programmes referred to in Article 20 of this Regulation; (ii) actions relating to cross-border links of the comprehensive network in accordance with Chapter II of Regulation (EU) No 1315/2013, such as those listed in Part III, point 2, of the Annex to this Regulation, actions referred to in Part III, point 3, of the Annex to this Regulation, actions relating to studies for the development of the comprehensive network and actions relating to maritime and inland ports of the comprehensive network in accordance with Chapter II of Regulation (EU) No 1315/2013; (iii) actions to re-establish missing regional cross-border rail connections on the TEN-T that have been abandoned or dismantled; (iv) actions implementing sections of the comprehensive network located in outermost regions in accordance with Chapter II of Regulation (EU) No 1315/2013, including actions relating to the relevant urban nodes, maritime ports, inland ports, rail-road terminals, connections to airports and multimodal logistics platforms, of the comprehensive network as defined in Annex II to Regulation (EU) No 1315/2013; (v) actions supporting projects of common interest in order to connect the trans-European network with infrastructure networks of neighbouring countries as defined in Article 8(1) of Regulation (EU) No 1315/2013; (b) actions relating to smart, interoperable, sustainable, multimodal, inclusive, accessible, safe and secure mobility: (i) actions supporting motorways of the sea as provided for in Article 21 of Regulation (EU) No 1315/2013 with a focus on cross-border short-sea shipping; (ii) actions supporting telematic applications systems in accordance with Article 31 of Regulation (EU) No 1315/2013, for the respective modes of transport, including in particular: \u2014 for railways: ERTMS, \u2014 for inland waterways: River Information Services (RIS), \u2014 for road transport: Intelligent Transport Systems (ITS), \u2014 for maritime transport: Vessel Traffic Monitoring and Information Systems (VTMIS) and e-Maritime services, including single-window services such as the maritime single window, port community systems and relevant customs information systems, \u2014 for air transport: air traffic management systems, in particular those resulting from the Single European Sky ATM Research (SESAR) system; (iii) actions supporting sustainable freight transport services in accordance with Article 32 of Regulation (EU) No 1315/2013 and actions to reduce rail freight noise; (iv) actions supporting new technologies and innovation, including automation, enhanced transport services, modal integration and alternative fuels infrastructure for all modes of transport in accordance with Article 33 of Regulation (EU) No 1315/2013; (v) actions to remove barriers to interoperability as defined in Article 3, point (o), of Regulation (EU) No 1315/2013, notably barriers when delivering corridor/network effects, including actions promoting an increase in rail freight traffic and automatic gauge-change facilities; (vi) actions to remove barriers to interoperability, in particular in urban nodes within the meaning of Article 30 of Regulation (EU) No 1315/2013; (vii) actions implementing safe and secure infrastructure and mobility, including road safety, in accordance with Article 34 of Regulation (EU) No 1315/2013; (viii) actions improving transport infrastructure resilience, in particular its resilience to climate change and natural disasters and to cyber security threats; (ix) actions improving transport infrastructure accessibility in all modes of transport and for all users, especially users with reduced mobility, in accordance with Article 37 of Regulation (EU) No 1315/2013; (x) actions improving transport infrastructure accessibility and availability for security and civil protection purposes and actions adapting the transport infrastructure for Union external border checks purposes with the aim of facilitating traffic flows; (c) under the specific objective referred to in Article 3(2), point (a)(ii), and in accordance with Article 12, actions or specific activities within an action, supporting parts, new or existing, of the TEN-T suitable for military transport, in order to adapt the TEN-T to dual-use infrastructure requirements. 3. In the energy sector, only the following actions shall be eligible to receive Union financial support under this Regulation: (a) actions relating to projects of common interest as set out at Article 14 of Regulation (EU) No 347/2013; (b) actions supporting cross-border projects in the field of renewable energy, including innovative solutions, as well as storage of renewable energy, and their conception, as defined in Part IV of the Annex, subject to the fulfilment of the conditions laid down in Article 7. 4. In the digital sector, only the following actions shall be eligible to receive Union financial support under this Regulation: (a) actions supporting the deployment of and access to very high capacity networks, including 5G systems, capable of providing Gigabit connectivity in areas where socioeconomic drivers are located; (b) actions supporting the provision of very high-quality local wireless connectivity in local communities that is free of charge and without discriminatory conditions; (c) actions implementing the uninterrupted coverage with 5G systems of all major transport paths, including the TEN-T, such as the actions listed in Part V, point 3, of the Annex; (d) actions supporting the deployment of new or the significant upgrading of existing backbone networks, including submarine cables, within and between Member States and between the Union and third countries, such as the actions listed in Part V, point 3, of the Annex, as well as other actions supporting the deployment of backbone networks referred to in that point; (e) actions implementing digital connectivity infrastructure requirements related to cross-border projects in the areas of transport or energy or supporting operational digital platforms directly associated to transport or energy infrastructures, or both. Article 10 Synergies between the transport, energy and digital sectors 1. Actions contributing simultaneously to the achievement of one or more objectives of at least two sectors, as provided for in Article 3(2), points (a), (b) and (c), shall be eligible to receive Union financial support under this Regulation and to benefit from a higher co-funding rate, in accordance with Article 15. Such actions shall be implemented through work programmes addressing at least two sectors and including specific award criteria, and shall be financed with budget contributions from the sectors involved. 2. Within each of the transport, energy or digital sectors, actions eligible in accordance with Article 9 may include synergetic elements relating to any of the other sectors, which are not related to eligible actions provided for in Article 9(2), (3) or (4) respectively, provided that they comply with all of the following requirements: (a) the cost of the synergetic elements does not exceed 20 % of the total eligible costs of the action; (b) the synergetic elements relate to the transport, energy or digital sector; and (c) the synergetic elements enable the socioeconomic, climate or environmental benefits of the action to be significantly improved. Article 11 Eligible entities 1. As regards entities, the eligibility criteria set out in this Article shall apply in addition to the criteria set out in Article 197 of the Financial Regulation. 2. The following entities shall be eligible: (a) legal entities established in: (i) a Member State, including joint ventures; (ii) a third country associated to the CEF; or (iii) an overseas country or territory; (b) legal entities created under Union law and, if provided for in the work programmes, international organisations. 3. Natural persons shall not be eligible. 4. The work programmes may provide that legal entities established in third countries associated to the CEF in accordance with Article 5, and legal entities established in the Union but directly or indirectly controlled by third countries or nationals of third countries or by entities established in third countries, are not eligible to participate in all or some of the actions under the specific objectives set out in Article 3(2), point (c), for duly justified security reasons. In such cases, calls for proposals and calls for tenders shall be restricted to entities established, or deemed to be established, in Member States and directly or indirectly controlled by Member States or by nationals of Member States. 5. Legal entities established in a third country which is not associated to the CEF shall exceptionally be eligible to receive Union financial support under the CEF where this is indispensable for the achievement of the objectives of a given project of common interest in the transport, energy and digital sectors or of a cross-border project in the field of renewable energy. 6. To be eligible, proposals shall be submitted: (a) by one or more Member States; or (b) with the agreement of the Member States concerned, by international organisations, joint undertakings, or by public or private undertakings or bodies, including regional or local authorities. If the Member State concerned does not agree with a submission under point (b) of the first subparagraph, it shall communicate that information accordingly. A Member State may decide that, for a specific work programme or for specific categories of applications, proposals may be submitted without its agreement. In such case, this shall, at the request of the Member State concerned, be indicated in the relevant work programme and in the call for such proposals. Article 12 Specific eligibility rules concerning actions relating to the adaptation of the TEN-T to civilian-defence dual use 1. Actions contributing to the adaptation of the TEN-T core network or comprehensive network as defined by Regulation (EU) No 1315/2013, with the purpose of enabling civilian-defence dual use of the infrastructure, shall be subject to the following additional eligibility rules: (a) the proposals shall be submitted by one or more Member States or, with the agreement of the Member States concerned, by legal entities established in Member States; (b) the actions shall relate to the sections or nodes identified by Member States in the Annexes to the Military Requirements for Military Mobility within and beyond the EU as adopted by the Council on 20 November 2018, or any subsequent list adopted thereafter, and to any further indicative list of priority projects that are identified by Member States in accordance with the Military Mobility Action Plan; (c) the actions may relate both to the upgrading of existing infrastructure components or to the construction of new infrastructure components taking into account the infrastructure requirements referred to in paragraph 2 of this Article; (d) actions implementing a level of infrastructure requirement going beyond the level required for dual use shall be eligible; however, their cost shall only be eligible up to the level of costs corresponding to the level of requirements necessary for dual use; actions relating to infrastructure used only for military purposes shall not be eligible; (e) actions under this Article shall only be funded from the amount in accordance with Article 4(2), point (a)(iii), of this Regulation. 2. The Commission shall adopt an implementing act specifying, where necessary, the infrastructure requirements applicable to certain categories of dual-use infrastructure actions and the evaluation procedure regarding the actions connected with dual-use infrastructure actions. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24(2). 3. Following the interim evaluation of the CEF provided for in Article 23(2), the Commission may propose to the budgetary authority that it transfer the money that has not been committed from Article 4(2), point (a)(iii), to Article 4(2), point (a)(i). CHAPTER III GRANTS Article 13 Grants Grants under the CEF shall be awarded and managed in accordance with Title VIII of the Financial Regulation. Article 14 Award criteria 1. Transparent award criteria shall be laid down in the work programmes referred to in Article 20 and in the calls for proposals, taking into account, to the extent applicable, only the following elements: (a) economic, social and environmental impact, including climate impact (project life cycle benefits and costs), soundness, comprehensiveness and transparency of the analysis; (b) innovation and digitalisation, safety, interoperability and accessibility aspects, including for persons with reduced mobility; (c) cross-border dimension, network integration and territorial accessibility, including for European islands and outermost regions; (d) Union added value; (e) synergies between the transport, energy and digital sectors; (f) maturity of the action in the light of the development of the project; (g) soundness of the maintenance strategy proposed for the project upon completion; (h) soundness of the implementation plan proposed; (i) catalytic effect of Union financial support on investment; (j) need to overcome financial obstacles such as those caused by insufficient commercial viability, high upfront costs or the lack of market finance; (k) potential for dual use in the context of military mobility; (l) consistency with Union and national energy and climate plans, including the \u201cenergy efficiency first\u201d principle. 2. The assessment of proposals against the award criteria shall take into account, where relevant, the resilience to the adverse impacts of climate change through a climate vulnerability and risk assessment, including the relevant adaptation measures. 3. The assessment of proposals against the award criteria shall, where relevant, as specified in the work programmes, ensure that actions supported by the CEF that include PNT technology are technically compatible with the Galileo and EGNOS programmes and with the Copernicus programme. 4. As regards actions relating to the transport sector, the assessment of proposals against the award criteria shall, where applicable, ensure that proposed actions are consistent with the corridor work plans and implementing acts pursuant to Article 47 of Regulation (EU) No 1315/2013 and that they take into account the consultative opinion of the responsible European Coordinator pursuant to Article 45(8) thereof. The assessment shall also consider whether the implementation of actions financed by the CEF risks causing disruption to freight and passenger flows on the section of the line concerned by the project and whether those risks have been mitigated. 5. As regards actions relating to cross-border projects in the field of renewable energy, the award criteria shall take into account the conditions laid down in Article 7(4). 6. As regards actions relating to projects of common interest in the field of digital connectivity, the award criteria set out in the work programmes and the calls for proposals shall take into account the criteria laid down in Article 8(4). Article 15 Co-financing rates 1. For studies, the amount of Union financial support shall not exceed 50 % of the total eligible cost. For studies financed with the amounts transferred from the Cohesion Fund, the maximum co-financing rates shall be those applicable to the Cohesion Fund as specified in paragraph 2, point (c). 2. For works in the transport sector, the following maximum co-financing rates shall apply: (a) for works relating to the specific objectives referred to in Article 3(2), point (a)(i), the amount of Union financial support shall not exceed 30 % of the total eligible cost; however, the co-financing rates may be increased to a maximum of 50 % for the actions: (i) relating to cross-border links under the conditions specified in point (e) of this paragraph; (ii) supporting telematic applications systems; (iii) supporting inland waterways or railway interoperability; (iv) supporting new technologies and innovation; (v) supporting improvements in infrastructure for safety; and (vi) adapting the transport infrastructure for Union external border checks purposes, in accordance with relevant Union law; (b) for works relating to the specific objectives referred to in Article 3(2), point (a)(ii), the amount of Union financial support shall not exceed 50 % of the total eligible cost; however, the co-financing rates may be increased to a maximum of 85 % if the necessary resources are transferred to the CEF pursuant to Article 4(13); (c) as regards the amounts transferred from the Cohesion Fund, the maximum co-financing rates shall not exceed 85 % of the total eligible costs; (d) as regards the amounts from the European Strategic Investment heading of EUR 1 559 800 000, as referred to in Part II, first paragraph, first indent, of the Annex, for the completion of missing major cross-border railway links between Member States eligible for funding from the Cohesion Fund, the maximum co-financing rates shall not exceed 85 % of the total eligible costs; (e) as regards actions relating to cross-border links, the increased maximum co-financing rates provided for in points (a), (c) and (d) of this paragraph may only apply to actions that demonstrate a high degree of integration in the planning and implementation of the action for the purpose of the award criterion referred to in Article 14(1), point (c), for instance through the establishment of a single project company, a joint governance structure, a bilateral legal framework or by an implementing act pursuant to Article 47 of Regulation (EU) No 1315/2013; in addition, the co-financing rate applicable to projects carried out by integrated management structures, including joint ventures, in accordance with Article 11(2), point (a), may be increased by 5 %. 3. For works in the energy sector, the following maximum co-financing rates shall apply: (a) for works relating to the specific objectives referred to in Article 3(2), point (b), the amount of Union financial support shall not exceed 50 % of the total eligible cost; (b) the co-financing rates may be increased to a maximum of 75 % of the total eligible cost for actions contributing to the development of projects of common interest which, based on the evidence referred to in Article 14(2) of Regulation (EU) No 347/2013, provide a high degree of regional or Union-wide security of supply, strengthen the solidarity of the Union or offer highly innovative solutions. 4. For works in the digital sector, the following maximum co-financing rates shall apply: for works relating to the specific objectives referred to in Article 3(2), point (c), the amount of Union financial support shall not exceed 30 % of the total eligible cost. The co-financing rates may be increased: (a) up to 50 % for actions with a strong cross-border dimension, such as uninterrupted coverage with 5G systems along major transport paths or deployment of backbone networks between Member States and between the Union and third countries; and (b) up to 75 % for actions implementing the Gigabit connectivity of socioeconomic drivers. Actions providing local wireless connectivity in local communities, when implemented via low value grants, may be funded by Union financial support covering up to 100 % of the eligible costs, without prejudice to the principle of co-financing. 5. The maximum co-funding rate applicable to actions referred to in Article 10(1) shall be the highest maximum co-funding rate applicable to the sectors concerned. In addition, the co-financing rate applicable to those actions may be increased by 10 %. 6. In each of the transport, energy and digital sectors, as regards works undertaken in outermost regions, a specific maximum co-funding rate of 70 % shall apply. Article 16 Eligible costs The following cost-eligibility criteria shall apply, in addition to the criteria set out in Article 186 of the Financial Regulation: (a) only expenditure incurred in Member States is eligible, except where the project of common interest or cross-border projects in the field of renewable energy involves the territory of one or more third countries as referred to in Article 5 or Article 11(4) of this Regulation or international waters, and where the action is indispensable to the achievement of the objectives of the project concerned; (b) the cost of equipment, facilities and infrastructure which is treated as capital expenditure by the beneficiary is eligible up to its entirety; (c) expenditure related to the purchase of land is not an eligible cost, except for funds transferred from the Cohesion Fund in the transport sector in accordance with Article 64 of Regulation (EU) 2021/1060; (d) eligible costs shall not include value added tax. Article 17 Combination of grants with other sources of financing 1. Grants may be used in combination with financing from the European Investment Bank or National Promotional Banks or other development and public financial institutions, as well as from private-sector finance institutions and private-sector investors, including through public private partnerships. 2. The use of grants referred to in paragraph 1 may be implemented through dedicated calls for proposals. Article 18 Reduction or termination of the grants 1. In addition to the grounds specified in Article 131(4) of the Financial Regulation, the amount of the grant may, except in duly justified cases, be reduced on the following grounds: (a) for studies, the action has not started within one year following the starting date indicated in the grant agreement; (b) for works, the action has not started within two years following the starting date indicated in the grant agreement; (c) following a review of the progress of the action, it is established that the implementation of the action has suffered such major delays that the objectives of the action are unlikely to be achieved; 2. The grant agreement may be amended or terminated on the basis of the grounds specified in paragraph 1. 3. Before any decision regarding the reduction or termination of a grant is taken, the case shall be examined comprehensively and the beneficiaries concerned shall be given the possibility to submit their observations within a reasonable time-frame. 4. Available commitment appropriations resulting from the application of paragraph 1 or 2 of this Article shall be distributed to other work programmes proposed under the corresponding financial envelope set out in Article 4(2). Article 19 Cumulative and alternative funding 1. An action that has received a contribution under the CEF may also receive a contribution from another Union programme, including funds under shared management, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 2. The Seal of Excellence label shall be awarded to actions which comply with the following cumulative conditions: (a) they have been assessed in a call for proposals under the CEF; (b) they comply with the minimum quality requirements of that call for proposals; (c) they cannot be financed under that call for proposals due to budgetary constraints. It shall be possible for actions that have been awarded a Seal of Excellence label in accordance with the first subparagraph to receive support from the ERDF in accordance with Article 67(5) of Regulation (EU) 2021/1060 or from the Cohesion Fund, without any further assessment, and provided that such actions are consistent with the objectives and rules of the Fund concerned. CHAPTER IV PROGRAMMING, MONITORING, EVALUATION AND CONTROL Article 20 Work programmes 1. The CEF shall be implemented by work programmes referred to in Article 110 of the Financial Regulation. 2. In order to provide transparency and predictability and to enhance the quality of the projects, the Commission shall adopt by 15 October 2021 the first multiannual work programmes. Those first multiannual work programmes shall include the timetable of the calls for proposals for the first three years of the CEF, their topics and indicative budget, as well as a prospective framework covering the entire programming period. 3. The work programmes shall be adopted by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24(2). 4. When adopting work programmes in the energy sector, the Commission shall give particular consideration to projects of common interest and related actions that aim to further integrate the internal market for energy, ending energy isolation and eliminating electricity interconnection bottlenecks, with an emphasis on those projects contributing to the achievement of the interconnection target of at least 10 % by 2020 and 15 % by 2030, as well as to projects contributing to synchronisation of electricity systems with Union networks. 5. In accordance with Article 200(2) of the Financial Regulation, the authorising officer responsible may, where appropriate, organise the selection procedure in two stages as follows: (a) applicants shall submit a simplified dossier containing relatively brief information for the purposes of project preselection based on a limited set of criteria; (b) applicants short-listed at the first stage shall submit a complete dossier after closure of the first stage. Article 21 Granting of Union financial support 1. Following every call for proposals based on the work programmes referred to in Article 20, the Commission shall adopt an implementing act setting the amount of financial support to be granted to the projects selected or to parts thereof and specifying the conditions and methods for their implementation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24(2). 2. During the implementation of the grant agreements the beneficiaries and the Member States concerned shall be informed by the Commission regarding changes to the grant amounts and the final amounts paid. 3. The beneficiaries shall submit reports as defined in the respective grant agreements without prior approval of the Member States. The Commission shall provide Member States with access to the reports regarding actions located on their territories. Article 22 Monitoring and reporting 1. Indicators to report on the progress of the CEF towards the achievement of the general and specific objectives laid down in Article 3 are set out in Part I of the Annex. 2. To ensure effective assessment of the CEF\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 26, to amend Part I of the Annex with regard to the indicators where considered necessary as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 3. The performance reporting system shall ensure that data for monitoring the implementation and the results of the CEF are suitable for an in-depth analysis of the progress achieved, including for climate tracking, and that they are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where appropriate, on Member States. 4. The Commission shall improve the dedicated internet site, by publishing, in real time, a map with the projects that are being implemented, together with relevant information, including impact assessments and the value, beneficiary, implementing entity and state of play of the project. The Commission shall also present progress reports every two years. Those progress reports shall include the information on the implementation of the CEF, in accordance with the general and specific objectives laid down in Article 3, clarifying whether the different sectors are on track, whether the total budgetary commitment is in line with the total amount allocated, whether the on-going projects are sufficiently complete, and whether it is still feasible and appropriate to deliver them. Article 23 Evaluation 1. Evaluations shall be carried out in a timely manner so that their results can be fed into the decision-making process. 2. An interim evaluation of the CEF shall be carried out once there is sufficient information available about the implementation of the CEF, but no later than four years after the start of implementation of the CEF. 3. At the end of the implementation of the CEF, but no later than four years after the end of the period specified in Article 1, the Commission shall carry out a final evaluation of the CEF. 4. The Commission shall submit the conclusions of the evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 24 Committee procedure 1. The Commission shall be assisted by the CEF Coordination Committee, which may meet in different formations depending on the respective topic. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 25 Delegated acts 1. The Commission is empowered to adopt delegated acts in accordance with Article 26, supplementing this Regulation by: (a) establishing a monitoring and evaluation framework based on the indicators as set out in Part I of the Annex; (b) laying down rules regarding the selection of cross-border projects in the field of renewable energy additional to those in Part IV of the Annex, and establishing and updating a list of selected cross\u2013border projects in the field of renewable energy. 2. Subject to Article 172, second subparagraph, TFEU, the Commission is empowered to adopt delegated acts in accordance with Article 26 of this Regulation: (a) to amend Part III of the Annex regarding the definition of the transport core network corridors and pre-identified sections on the comprehensive network; (b) to amend Part V of the Annex regarding the identification of digital connectivity projects of common interest. Article 26 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 22(2) and Article 25 shall be conferred on the Commission until 31 December 2028. 3. The delegation of power referred to in Article 7(2), Article 22(2) and Article 25 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 7(2), Article 22(2) and Article 25 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 27 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the CEF, to actions taken pursuant to the CEF and to the results obtained. Financial resources allocated to the CEF shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. 3. Transparency and public consultation shall be ensured in compliance with the applicable Union and national law. Article 28 Protection of the financial interest of the Union Where a third country participates in the CEF by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. CHAPTER V TRANSITIONAL AND FINAL PROVISIONS Article 29 Repeal and transitional provisions 1. Regulations (EU) No 1316/2013 and (EU) No 283/2014 are repealed. 2. Without prejudice to paragraph 1, this Regulation shall not affect the continuation or modification of actions initiated pursuant to Regulation (EU) No 1316/2013, which shall continue to apply to those actions until their closure. 3. The financial envelope for the CEF may also cover the technical and administrative assistance expenses necessary to ensure the transition between the CEF and the measures adopted pursuant to Regulation (EU) No 1316/2013. 4. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 4(5), to enable the management of actions not completed by 31 December 2027, in accordance with this Regulation. Article 30 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 7 July 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. LOGAR (1) OJ C 440, 6.12.2018, p. 191. (2) OJ C 461, 21.12.2018, p. 173. (3) Position of the European Parliament of 17 April 2019 (OJ C 158, 30.4.2021, p. 884) and position of the Council at first reading of 14 June 2021 (OJ C 276, 9.7.2021, p. 1). Position of the European Parliament of 6 July 2021 (not yet published in the Official Journal). (4) OJ L 282, 19.10.2016, p. 4. (5) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). (6) Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1). (7) Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, p. 1). (8) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (9) Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1). (10) Directive 2008/96/EC of the European Parliament and of the Council of 19 November 2008 on road infrastructure safety management (OJ L 319, 29.11.2008, p. 59). (11) Regulation (EU) 2021/1058 of the European Parliament and of the Council of 24 June 2021 on the European Regional Development Fund and on the Cohesion Fund (OJ L 231, 30.6.2021, p. 60). (12) Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (OJ L 115, 25.4.2013, p. 39). (13) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). (14) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1). (15) Regulation (EU) No 283/2014 of the European Parliament and of the Council of 11 March 2014 on guidelines for trans-European networks in the area of telecommunications infrastructure and repealing Decision No 1336/97/EC (OJ L 86, 21.3.2014, p. 14). (16) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36). (17) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, p. 1). (18) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (19) OJ L 433 I, 22.12.2020, p. 28. (20) OJ L 1, 3.1.1994, p. 3. (21) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (22) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (23) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (24) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (25) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (26) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (\u2018Overseas Association Decision\u2019) (OJ L 344, 19.12.2013, p. 1). (27) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (28) OJ L 123, 12.5.2016, p. 1. (29) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (30) Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010 (OJ L 348, 20.12.2013, p. 129). (31) Regulation (EU) No 913/2010 of the European Parliament and of the Council of 22 September 2010 concerning a European rail network for competitive freight (OJ L 276, 20.10.2010, p. 22). (32) The financial envelope of the CEF for the period 2021-2027 in constant 2018 prices is EUR 29 896 000 000 and is distributed as follows: (a) transport: EUR 22 884 000 000, of which (i) EUR 11 384 000 000 from the MFF 2021-2027, Heading 1(2), European Strategic Investment; (ii) EUR 10 000 000 000 transferred from the Cohesion Fund; (iii) EUR 1 500 000 000 from the MFF 2021-2027, Heading 5(13), Defence; (b) energy: EUR 5 180 000 000; (c) digital: EUR 1 832 000 000. (33) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). ANNEX PART I INDICATORS The CEF will be monitored closely on the basis of a set of indicators intended to measure the extent to which the general and specific objectives of the CEF have been achieved and with a view to minimising administrative burdens and costs. To that end, data will be collected as regards the following set of key indicators: Sectors Specific Objectives Key Indicators Transport Efficient, interconnected and multimodal networks and infrastructure for smart, interoperable, sustainable, inclusive, accessible, safe and secure mobility Number of cross-border and missing links addressed with the support of the CEF (including actions relating to urban nodes, regional cross-border rail connections, multimodal logistics platforms, maritime ports, inland ports, connections to airports and rail-road terminals of the TEN-T core network and comprehensive network) Number of actions supported by the CEF contributing to the digitalisation of transport, in particular through the deployment of ERTMS, RIS, ITS, VTMIS/e-Maritime services and SESAR Number of alternative fuel supply points built or upgraded with the support of the CEF Number of actions supported by the CEF contributing to the safety of transport Number of actions supported by the CEF contributing to transport accessibility for persons with reduced mobility Number of actions supported by the CEF contributing to the reduction in rail freight noise Adaptation for the dual-use of transport infrastructure Number of transport infrastructure components adapted to dual-use requirements Energy Contribution to interconnectivity and integration of markets Number of actions supported by the CEF contributing to projects interconnecting MS networks and removing internal constraints Security of supply Number of actions supported by the CEF contributing to projects ensuring resilient gas network Number of actions supported by the CEF contributing to the smartening and digitalisation of grids and increasing energy storage capacity Sustainable development through enabling decarbonisation Number of actions supported by the CEF contributing to projects enabling increased penetration of renewable energy in energy systems Number of actions supported by the CEF contributing to cross-border cooperation in the field of renewable energy Digital Contribution to the deployment of digital connectivity infrastructure throughout the Union New connections to very high capacity networks for socioeconomic drivers and very high-quality connections for local communities Number of actions supported by the CEF enabling 5G coverage along major transport paths Number of actions supported by the CEF enabling new connections to very high capacity networks Number of actions supported by the CEF contributing to the digitalisation of energy and transport sectors PART II INDICATIVE PERCENTAGES FOR THE TRANSPORT SECTOR The budgetary resources referred to in Article 4(2), point (a)(i), shall be distributed as follows: \u2014 60 % for the actions listed in Article 9(2), point (a): \u201cActions relating to efficient, interconnected, interoperable and multimodal networks\u201d out of which EUR 1 559 800 000 (1) to be allocated, in priority and on a competitive basis, to the completion of missing major cross-border railway links between Member States eligible for funding from the Cohesion Fund; \u2014 40 % for the actions listed in Article 9(2), point (b): \u201cActions relating to smart, interoperable, sustainable, multimodal, inclusive, accessible, safe and secure mobility\u201d. The budgetary resources referred to in Article 4(2), point (a)(ii), shall be distributed as follows: \u2014 85 % for the actions listed in Article 9(2), point (a): \u201cActions relating to efficient, interconnected, interoperable and multimodal networks\u201d; \u2014 15 % for the actions listed in Article 9(2), point (b): \u201cActions relating to smart, interoperable, sustainable, multimodal, inclusive, accessible, safe and secure mobility\u201d. For the actions listed in Article 9(2), point (a), 85 % of the budgetary resources should be allocated to actions on the core network and 15 % to actions on the comprehensive network. PART III TRANSPORT CORE NETWORK CORRIDORS AND CROSS-BORDER LINKS ON THE COMPREHENSIVE NETWORK 1. Core network corridors and indicative list of pre-identified cross-border links and missing links Core network corridor \u201cAtlantic\u201d Alignment Gij\u00f3n \u2013 Le\u00f3n \u2013 Valladolid A Coru\u00f1a \u2013 Vigo \u2013 Orense \u2013 Le\u00f3n Zaragoza \u2013 Pamplona/Logro\u00f1o \u2013 Bilbao Tenerife/Gran Canaria \u2013 Huelva/Sanl\u00facar de Barrameda \u2013 Sevilla \u2013 C\u00f3rdoba Algeciras \u2013 Bobadilla \u2013 Madrid Sines/Lisboa \u2013 Madrid \u2013 Valladolid Lisboa \u2013 Aveiro \u2013 Leix\u00f5es/Porto \u2013 Douro river Sionainn Faing or Shannon Foynes/Baile \u00c1tha Cliath or Dublin/Corcaigh or Cork \u2013 Le Havre \u2013 Rouen \u2013 Paris Aveiro \u2013 Valladolid \u2013 Vitoria-Gasteiz \u2013 Bergara \u2013 Bilbao/Bordeaux \u2013 Toulouse/Tours \u2013 Paris \u2013 Metz \u2013 Mannheim/Strasbourg Sionainn Faing or Shannon Foynes/Baile \u00c1tha Cliath or Dublin/Corcaigh or Cork \u2013 Saint Nazaire \u2013 Nantes \u2013 Tours \u2013 Dijon Cross-border links \u00c9vora \u2013 M\u00e9rida Rail Vitoria-Gasteiz \u2013 San Sebasti\u00e1n \u2013 Bayonne \u2013 Bordeaux Aveiro \u2013 Salamanca Douro river (Via Naveg\u00e1vel do Douro) Inland waterways Missing links Non-UIC gauge interoperable lines on the Iberian Peninsula Rail Core network corridor \u201cBaltic \u2013 Adriatic\u201d Alignment Gdynia \u2013 Gda\u0144sk \u2013 Katowice/S\u0142awk\u00f3w Gda\u0144sk \u2013 Warszawa \u2013 Katowice/Krak\u00f3w Katowice \u2013 Ostrava \u2013 Brno \u2013 Wien Szczecin/\u015awinouj\u015bcie \u2013 Pozna\u0144 \u2013 Wroc\u0142aw \u2013 Ostrava Katowice \u2013 Bielsko-Bia\u0142a \u2013 \u017dilina \u2013 Bratislava \u2013 Wien Wien \u2013 Graz\u2013 Villach \u2013 Udine \u2013 Trieste Udine \u2013 Venezia \u2013 Padova \u2013 Bologna \u2013 Ravenna \u2013 Ancona Graz \u2013 Maribor \u2013Ljubljana \u2013 Koper/Trieste Cross-border links Katowice/Opole \u2013 Ostrava \u2013 Brno Katowice \u2013 \u017dilina Bratislava \u2013 Wien Graz \u2013 Maribor Venezia \u2013 Trieste \u2013 Diva\u010da \u2013 Ljubljana Rail Katowice \u2013 \u017dilina Brno \u2013 Wien Road Missing links Gloggnitz \u2013 M\u00fcrzzuschlag: Semmering base tunnel Graz \u2013 Klagenfurt: Koralm railway line and tunnel Koper \u2013 Diva\u010da Rail Core network corridor \u201cMediterranean\u201d Alignment Algeciras \u2013 Bobadilla \u2013Madrid \u2013 Zaragoza \u2013 Tarragona Madrid \u2013 Valencia \u2013 Sagunto \u2013 Teruel \u2013 Zaragoza Sevilla \u2013 Bobadilla \u2013 Murcia Cartagena \u2013 Murcia \u2013 Valencia \u2013 Tarragona/Palma de Mallorca \u2013 Barcelona Tarragona \u2013 Barcelona \u2013 Perpignan \u2013 Narbonne \u2013 Toulouse/Marseille \u2013 Genova/Lyon \u2013 La Spezia/Torino \u2013 Novara \u2013 Milano \u2013 Bologna/Verona \u2013 Padova \u2013 Venezia \u2013 Ravenna/Trieste/Koper \u2013 Ljubljana \u2013 Budapest Ljubljana/Rijeka \u2013 Zagreb \u2013 Budapest \u2013 UA border Cross-border links Barcelona \u2013 Perpignan Rail Lyon \u2013 Torino: base tunnel and access routes Nice \u2013 Ventimiglia Venezia \u2013 Trieste \u2013 Diva\u010da \u2013 Ljubljana Ljubljana \u2013 Zagreb Zagreb \u2013 Budapest Budapest \u2013 Miskolc \u2013 UA border Lendava \u2013 Letenye Road V\u00e1s\u00e1rosnam\u00e9ny \u2013 UA border Missing links Almer\u00eda \u2013 Murcia Rail Non-UIC gauge interoperable lines on the Iberian Peninsula Perpignan \u2013 Montpellier Koper \u2013 Diva\u010da Rijeka \u2013 Zagreb Milano \u2013 Cremona \u2013 Mantova \u2013 Porto Levante/Venezia \u2013 Ravenna/Trieste Inland waterways Core network corridor \u201cNorth Sea \u2013 Baltic\u201d Alignment Lule\u00e5 \u2013 Helsinki \u2013 Tallinn \u2013 R\u012bga Ventspils \u2013 R\u012bga R\u012bga \u2013 Kaunas Klaip\u0117da \u2013 Kaunas \u2013 Vilnius Kaunas \u2013 Warszawa BY border \u2013 Warszawa \u2013 \u0141\u00f3d\u017a/Pozna\u0144 \u2013 Frankfurt (Oder) \u2013 Berlin \u2013 Hamburg \u2013 Kiel \u0141\u00f3d\u017a \u2013 Katowice/Wroc\u0142aw UA border \u2013 Rzesz\u00f3w \u2013 Katowice \u2013 Wroc\u0142aw \u2013 Falkenberg \u2013 Magdeburg Szczecin/\u015awinouj\u015bcie \u2013 Berlin \u2013 Magdeburg \u2013 Braunschweig \u2013 Hannover Hannover \u2013 Bremen \u2013 Bremerhaven/Wilhelmshaven Hannover \u2013 Osnabr\u00fcck \u2013 Hengelo \u2013 Almelo \u2013 Deventer \u2013 Utrecht Utrecht \u2013 Amsterdam Utrecht \u2013 Rotterdam \u2013 Antwerpen Hannover/Osnabr\u00fcck \u2013 K\u00f6ln \u2013 Antwerpen Cross-border links Tallinn \u2013 R\u012bga \u2013 Kaunas \u2013 Warszawa: Rail Baltic new UIC gauge fully interoperable line Rail \u015awinouj\u015bcie/Szczecin \u2013 Berlin Rail and inland waterways Via Baltica Corridor EE-LV-LT-PL Road Missing links Kaunas \u2013 Vilnius: part of Rail Baltic new UIC gauge fully interoperable line Rail Warszawa/Idzikowice \u2013 Pozna\u0144/Wroc\u0142aw, incl. connections to the planned Central Transport Hub Nord-Ostsee-Kanal Inland waterways Berlin \u2013 Magdeburg \u2013 Hannover; Mittellandkanal; western German canals Rhine, Waal Noordzeekanaal, IJssel, Twentekanaal Core network corridor \u201cNorth Sea \u2013 Mediterranean\u201d Alignment UK border \u2013 Baile \u00c1tha Cliath or Dublin \u2013 Sionainn Faing or Shannon Foynes/Corcaigh or Cork Sionainn Faing or Shannon Foynes/Baile \u00c1tha Cliath or Dublin/Corcaigh or Cork \u2013 Le Havre/Calais/Dunkerque/Zeebrugge/Terneuzen/Gent/Antwerpen/Rotterdam/Amsterdam UK border \u2013 Lille \u2013 Brussel or Bruxelles Amsterdam \u2013 Rotterdam \u2013 Antwerpen \u2013 Brussel or Bruxelles \u2013 Luxembourg Luxembourg \u2013 Metz \u2013 Dijon \u2013 M\u00e2con \u2013 Lyon \u2013 Marseille Luxembourg \u2013 Metz \u2013 Strasbourg \u2013 Basel Antwerpen/Zeebrugge \u2013 Gent \u2013 Calais/Dunkerque/Lille \u2013 Paris\u2013 Rouen \u2013 Le Havre Cross-border links Brussel or Bruxelles \u2013 Luxembourg \u2013 Strasbourg Rail Terneuzen \u2013 Gent Inland waterways Seine \u2013 Scheldt Network and the related Seine, Scheldt and Meuse river basins Rhine-Scheldt corridor Missing links Albertkanaal/Canal Albert and Kanaal Bocholt-Herentals Inland waterways Core network corridor \u201cOrient/East-Med\u201d Alignment Hamburg \u2013 Berlin Rostock \u2013 Berlin \u2013 Dresden Bremerhaven/Wilhelmshaven \u2013 Magdeburg \u2013 Dresden Dresden \u2013 \u00dast\u00ed nad Labem \u2013 M\u011bln\u00edk/Praha \u2013 Lys\u00e1 nad Labem/Po\u0159\u00ed\u010dany \u2013 Kol\u00edn Kol\u00edn \u2013 Pardubice \u2013 Brno \u2013 Wien/Bratislava \u2013 Budapest \u2013 Arad \u2013 Timi\u015foara \u2013 Craiova \u2013 Calafat \u2013 Vidin \u2013 Sofia Sofia \u2013 RS border/MK border Sofia \u2013 Plovdiv \u2013 Burgas/TR border TR border \u2013 Alexandroupoli \u2013 Kavala \u2013 Thessaloniki \u2013 Ioannina \u2013 Kakavia/Igoumenitsa MK border \u2013 Thessaloniki Sofia \u2013 Thessaloniki \u2013 Athina \u2013 Piraeus/Ikonio \u2013Irakleio \u2013 Lemesos (Vasiliko) \u2013 Lefkosia/Larnaka Athina \u2013 Patra/Igoumenitsa Cross-border links Dresden \u2013 Praha/Kol\u00edn Rail Wien/Bratislava \u2013 Budapest B\u00e9k\u00e9scsaba \u2013 Arad \u2013 Timi\u015foara Craiova \u2013 Calafat \u2013 Vidin \u2013 Sofia \u2013 Thessaloniki Sofia \u2013 RS border/MK border TR border \u2013 Alexandroupoli MK border \u2013 Thessaloniki Ioannina \u2013 Kakavia (AL border) Road Drobeta Turnu Severin/Craiova \u2013 Vidin \u2013 Montana Sofia \u2013 RS border Hamburg \u2013 Dresden \u2013 Praha \u2013 Pardubice Inland waterways Missing links Igoumenitsa \u2013 Ioannina Praha \u2013 Brno Thessaloniki \u2013 Kavala \u2013 Alexandroupoli Timi\u015foara \u2013 Craiova Rail Core network corridor \u201cRhine \u2013 Alpine\u201d Alignment Genova \u2013 Milano \u2013 Lugano \u2013 Basel Genova \u2013 Novara \u2013 Brig \u2013 Bern \u2013 Basel \u2013 Karlsruhe \u2013 Mannheim \u2013 Mainz \u2013 Koblenz \u2013 K\u00f6ln K\u00f6ln \u2013 D\u00fcsseldorf \u2013 Duisburg \u2013 Nijmegen/Arnhem \u2013 Utrecht \u2013 Amsterdam Nijmegen \u2013 Rotterdam \u2013 Vlissingen K\u00f6ln \u2013 Li\u00e8ge \u2013 Brussel or Bruxelles \u2013 Gent Li\u00e8ge \u2013 Antwerpen \u2013 Gent \u2013 Zeebrugge Cross-border links Zevenaar \u2013 Emmerich \u2013 Oberhausen Rail Karlsruhe \u2013 Basel Milano/Novara \u2013 CH border Basel \u2013 Antwerpen/Rotterdam \u2013 Amsterdam Inland waterways Missing links Genova \u2013 Tortona/Novi Ligure Rail Zeebrugge \u2013 Gent Core network corridor \u201cRhine \u2013 Danube\u201d Alignment Strasbourg \u2013 Stuttgart \u2013 M\u00fcnchen \u2013 Wels/Linz Strasbourg \u2013 Mannheim \u2013 Frankfurt am Main \u2013 W\u00fcrzburg \u2013 N\u00fcrnberg \u2013 Regensburg \u2013 Passau \u2013 Wels/Linz M\u00fcnchen/N\u00fcrnberg \u2013 Praha \u2013 Ostrava/P\u0159erov \u2013 \u017dilina \u2013 Ko\u0161ice \u2013 UA border Wels/Linz \u2013 Wien \u2013 Bratislava \u2013 Budapest \u2013 Vukovar Wien/Bratislava \u2013 Budapest \u2013 Arad \u2013 Moravita/Bra\u0219ov/Craiova \u2013 Bucure\u0219ti \u2013 Giurgiu/Constanta \u2013 Sulina Cross-borderlinks M\u00fcnchen \u2013 Praha Rail N\u00fcrnberg \u2013 Plze\u0148 M\u00fcnchen \u2013 M\u00fchldorf \u2013 Freilassing \u2013 Salzburg Strasbourg \u2013 Kehl Appenweier Hranice \u2013 \u017dilina Ko\u0161ice \u2013 UA border Wien \u2013 Bratislava/Budapest Bratislava \u2013 Budapest B\u00e9k\u00e9scsaba \u2013 Arad \u2013 Timi\u015foara \u2013 RS border Bucure\u0219ti \u2013 Giurgiu \u2013 Rousse Danube (Kehlheim \u2013 Constan\u021ba/Midia/Sulina) and the related V\u00e1h, Sava and Tisza river basins Inland waterways Zl\u00edn \u2013 \u017dilina Road Timi\u015foara \u2013 RS border Missing links Stuttgart \u2013 Ulm Rail Salzburg \u2013 Linz Craiova \u2013 Bucure\u0219ti Arad \u2013 Sighi\u015foara \u2013 Bra\u0219ov- Predeal Core network corridor \u201cScandinavian \u2013 Mediterranean\u201d Alignment RU border \u2013 Hamina/Kotka \u2013 Helsinki \u2013 Turku/Naantali \u2013 Stockholm \u2013 \u00d6rebro(Hallsberg)/Link\u00f6ping \u2013 Malm\u00f6 Narvik/Oulu \u2013 Lule\u00e5 \u2013 Ume\u00e5 \u2013 Stockholm/\u00d6rebro (Hallsberg) Oslo \u2013 G\u00f6teborg \u2013 Malm\u00f6 \u2013 Trelleborg Malm\u00f6 \u2013 K\u00f8benhavn \u2013 Fredericia \u2013 Aarhus \u2013 Aalborg \u2013 Hirtshals/Frederikshavn K\u00f8benhavn \u2013 Kolding/L\u00fcbeck \u2013 Hamburg \u2013 Hannover Bremerhaven \u2013 Bremen \u2013 Hannover \u2013 N\u00fcrnberg Rostock \u2013 Berlin \u2013 Halle/Leipzig \u2013 Erfurt \u2013 M\u00fcnchen N\u00fcrnberg \u2013 M\u00fcnchen \u2013 Innsbruck \u2013 Verona \u2013 Bologna \u2013 Ancona/Firenze Livorno/La Spezia \u2013 Firenze \u2013 Roma \u2013 Napoli \u2013 Bari \u2013 Taranto \u2013 Valletta/Marsaxlokk Cagliari \u2013 Napoli \u2013 Gioia Tauro \u2013 Palermo/Augusta \u2013 Valletta/Marsaxlokk Cross-border links RU border \u2013 Helsinki Rail K\u00f8benhavn \u2013 Hamburg: Fehmarn belt fixed link access routes M\u00fcnchen \u2013 W\u00f6rgl \u2013 Innsbruck \u2013 Fortezza \u2013 Bolzano \u2013 Trento \u2013 Verona: Brenner base tunnel and its access routes G\u00f6teborg-Oslo K\u00f8benhavn \u2013 Hamburg: Fehmarn belt fixed link Rail/Road 2. Indicative list of pre-identified cross-border links on the comprehensive network The cross-border sections of the comprehensive network referred to in Article 9(2), point (a)(ii), include notably the following sections: Baile \u00c1tha Cliath or Dublin/Letterkenny \u2013 UK border Road Pau \u2013 Huesca Rail Lyon \u2013 CH border Rail Athus \u2013 Mont-Saint-Martin Rail Breda \u2013 Venlo \u2013 Viersen \u2013 Duisburg Rail Antwerpen \u2013 Duisburg Rail Mons \u2013 Valenciennes Rail Gent \u2013 Terneuzen Rail Heerlen \u2013 Aachen Rail Groningen \u2013 Bremen Rail Stuttgart \u2013 CH border Rail Gallarate/Sesto Calende \u2013 CH border Rail Berlin \u2013 Rzepin/Horka \u2013 Wroc\u0142aw Rail Praha \u2013 Linz Rail Villach \u2013 Ljubljana Rail Pivka \u2013 Rijeka Rail Plze\u0148 \u2013 \u010cesk\u00e9 Bud\u011bjovice \u2013 Wien Rail Wien \u2013 Gy\u0151r Rail Graz \u2013 Celld\u00f6m\u00f6lk \u2013 Gy\u0151r Rail Neumarkt-Kallham \u2013 M\u00fchldorf Rail Amber Corridor PL-SK-HU Rail Via Carpathia Corridor BY/UA border-PL-SK-HU-RO Road Foc\u0219ani \u2013 MD border Road Budapest \u2013 Osijek \u2013 Svilaj (BA border) Road Faro \u2013 Huelva Rail Porto \u2013 Vigo Rail Giurgiu \u2013 Varna Rail Svilengrad \u2013 Pithio Rail 3. Components of the comprehensive network located in Member States which do not have a land border with another Member State. PART IV SELECTION OF CROSS-BORDER PROJECTS IN THE FIELD OF RENEWABLE ENERGY 1. Objective of cross-border projects in the field of renewable energy Cross-border projects in the field of renewable energy shall promote cross-border cooperation between Member States in the field of planning, development and the cost-effective exploitation of renewable energy sources, as well as facilitate their integration through energy storage facilities and with the aim of contributing to the Union\u2019s long term decarbonisation strategy. 2. General criteria In order to qualify as a cross-border project in the field of renewable energy, a project shall meet all of the following general criteria: (a) the project shall be included in a cooperation agreement or any other kind of arrangement between two or more Member States or between one or more Member States and one or more third countries as set out in Articles 8, 9, 11 and 13 of Directive (EU) 2018/2001; (b) the project shall provide cost savings in the deployment of renewable energy or benefits for system integration, security of supply or innovation, or both, in comparison to a similar project or renewable energy project implemented by one of the participating Member States alone; (c) the potential overall benefits of cooperation outweigh its costs, including in the longer term, as assessed on the basis of the cost-benefit analysis as referred to in point 3 of this Part and applying the methodologies referred to in Article 7(2) of this Regulation. 3. Cost-benefit analysis (a) energy generation costs; (b) system integration costs; (c) support costs; (d) greenhouse gas emissions; (e) security of supply; (f) air and other local pollution, such as effects on local nature and the environment; (g) innovation. 4. Procedure (a) Promoters, including Member States, of a project that is potentially eligible for selection as a cross-border project in the field of renewable energy under a cooperation agreement or any other kind of arrangement between two or more Member States or between one or more Member States and one or more third countries as set out in Articles 8, 9, 11 and 13 of Directive (EU) 2018/2001 and that seeks to obtain the status of cross-border project in the field of renewable energy, shall submit an application for selection as a cross-border project in the field of renewable energy to the Commission. The application shall include the relevant information to allow the Commission to evaluate the project against the criteria laid down in points 2 and 3 of this Part, in line with the methodologies referred to in Article 7(2) of this Regulation. The Commission shall ensure that promoters are given the opportunity to apply for the status of cross-border project in the field of renewable energy at least once a year. (b) The Commission shall set up and chair a group for cross-border-projects in the field of renewable energy, composed of one representative of each Member State and one from the Commission. The group shall adopt its own rules of procedure. (c) At least once a year, the Commission shall organise the process for selection as cross-border projects. Following the evaluation of the projects, the Commission shall submit to the group referred to in point (b) of this point a list of eligible projects in the field of renewable energy that comply with the criteria set out in Article 7 and in point (d) of this point. (d) The group referred to in point (b) shall be given relevant information, unless commercially sensitive, on the eligible projects included in the list submitted by the Commission regarding the following criteria: (i) a confirmation of the compliance with the eligibility and selection criteria for all projects; (ii) information on the cooperation mechanism that a project pertains to and information regarding the extent to which a project has the support of one or several Member States; (iii) description of the objective of the project, including the estimated capacity (in kW) and, where available, renewable energy production (in kWh per annum), as well as the total project costs and eligible costs referred, in euro; (iv) information on the expected Union added value in accordance with point 2, (b), of this Part and on the expected costs and benefits and the expected Union added value in accordance with point 2, (c), of this Part. (e) The group may invite to its meetings, as appropriate, promoters of eligible projects, representatives of third countries involved in eligible projects and any other relevant stakeholders. (f) On the basis of the evaluation results, the group shall agree on a draft list of cross-border projects in the field of renewable energy, to be adopted in accordance with point (g). (g) The Commission shall adopt the final list of selected cross-border projects in the field of renewable energy by delegated act on the basis of a draft list referred to in point (f) and taking into account point (i). The Commission shall also publish on its website the list of selected cross-border projects in the field of renewable energy. That list shall be reviewed as necessary and at least every two years. (h) The group shall monitor the implementation of the projects on the final list and make recommendations on how to overcome possible delays in their implementation. For this purpose, project promoters of the selected projects shall provide information on the implementation of their projects. (i) The Commission shall, when selecting the cross-border projects in the field of renewable energy, aim to ensure an appropriate geographical balance in the selection of such projects. Regional groupings may be used for the selection of projects. (j) A project shall not be selected as a cross-border project in the field of renewable energy, or, if selected, shall have such status withdrawn, if information which was a determining factor in the evaluation, was incorrect, or if the project does not comply with Union law. PART V DIGITAL CONNECTIVITY INFRASTRUCTURE PROJECTS OF COMMON INTEREST 1. Gigabit connectivity, including 5G systems and other state-of-the-art connectivity, for socioeconomic drivers. Actions shall be prioritised taking into account the function of the socioeconomic drivers, the relevance of the digital services and applications enabled by providing the underlying connectivity, and the potential socioeconomic benefits to citizens, business and local communities, including the additional area coverage generated in terms of households. The available budget shall be allocated in a geographically balanced manner across Member States. Priority shall be given to actions contributing to Gigabit connectivity, including 5G systems and other state-of-the-art connectivity, for: (a) hospitals and medicals centres, in line with the efforts to digitalise the healthcare system, with a view to increasing the well-being of Union citizens and changing the way health and care services are delivered to patients; (b) education and research centres, in the context of the efforts to facilitate the use, inter alia, of high-speed computing, cloud applications and big data, close digital divides and to innovate in education systems, to improve learning outcomes, enhance equity and improve efficiency; (c) uninterrupted 5G wireless broadband coverage to all urban areas by 2025. 2. Wireless connectivity in local communities Actions that aim to provide local wireless connectivity in centres of local public life, including outdoor spaces accessible to the general public that play a major role in the public life of local communities, shall fulfil the following conditions in order to receive funding: (a) they are implemented by a public sector body as referred to in the second paragraph, which is capable of planning and supervising the installation, as well as ensuring for a minimum of three years the financing of operating costs, of indoor or outdoor local wireless access points in public spaces; (b) they build on very high capacity digital networks enabling the delivery of very high-quality internet experience to users that: (i) is free of charge and without discriminatory conditions, easy to access, secured and uses most recent and best available equipment, and is capable of delivering high-speed connectivity to its users; and (ii) supports widespread and non-discriminatory access to innovative digital services; (c) they use the common visual identity to be provided by the Commission and link to the associated multi-lingual online tools; (d) in view of achieving synergies and increasing capacity and improving user experience, they facilitate the deployment of 5G ready small-area wireless access points, as defined in Directive (EU) 2018/1972; and (e) they commit to procure the necessary equipment and/or related installation services in accordance with applicable law to ensure that projects do not unduly distort competition. Union financial support shall be available to public sector bodies as defined in Article 3, point (1), of Directive (EU) 2016/2102 of the European Parliament and of the Council (2) undertaking to provide, in accordance with national law, local wireless connectivity that is free of charge and without discriminatory conditions through the installation of local wireless access points. Funded actions shall not duplicate existing free private or public offers of similar characteristics, including quality, in the same public space. The available budget shall be allocated in a geographically balanced manner across Member States. Wherever relevant, coordination and coherence will be ensured with the actions supported by the CEF that promote access of socioeconomic drivers to very high capacity networks capable of providing Gigabit connectivity, including 5G systems and other state-of-the-art connectivity. 3. Indicative list of 5G corridors and cross-border backbone connections eligible for funding In line with the Gigabit society objectives set out by the Commission to ensure that major terrestrial transport paths have uninterrupted 5G coverage by 2025, actions implementing uninterrupted coverage with 5G systems pursuant to Article 9(4), point (c), include, as a first step, actions on the cross-border sections for connected automated mobility (CAM) experimentation, and, as a second step, actions on more extensive sections in view of a larger scale deployment of CAM along the corridors, as indicated in the table below (indicative list). The TEN-T corridors are used as a basis for this purpose, but the deployment of 5G is not necessarily confined to those corridors (3). Furthermore, actions supporting deployment of backbone networks, including with submarine cables across Member States and between the Union and third countries or connecting European islands, pursuant to Article 9(4), point (d), are also supported in order to provide necessary redundancy for such vital infrastructure, and to increase the capacity and resilience of the Union\u2019s digital networks. Core network corridor \u201cAtlantic\u201d Cross-border sections for CAM experimentation Porto \u2013 Vigo M\u00e9rida \u2013 \u00c9vora Paris \u2013 Amsterdam \u2013 Frankfurt am Main Aveiro \u2013 Salamanca San Sebasti\u00e1n \u2013 Biarritz More extensive section for larger scale deployment of CAM Metz \u2013 Paris \u2013 Bordeaux \u2013 Bilbao \u2013 Vigo \u2013 Porto \u2013 Lisboa Bilbao \u2013 Madrid \u2013 Lisboa Madrid \u2013 M\u00e9rida \u2013 Sevilla \u2013 Tarifa Deployment of backbone networks, including with submarine cables A\u00e7ores/Madeira Islands \u2013 Lisboa Core network corridor \u201cBaltic \u2013 Adriatic\u201d Cross-border sections for CAM experimentation More extensive section for larger scale deployment of CAM Gda\u0144sk \u2013 Warszawa \u2013 Brno \u2013 Wien \u2013 Graz \u2013 Ljubljana \u2013 Koper/Trieste Core network corridor \u201cMediterranean\u201d Cross-border sections for CAM experimentation More extensive section for larger scale deployment of CAM Budapest \u2013 Zagreb \u2013 Ljubljana \u2013 Rijeka \u2013 Split \u2013 Dubrovnik Ljubljana \u2013 Zagreb \u2013 Slavonski Brod \u2013 Bajakovo (RS border) Slavonski Brod \u2013 \u0110akovo \u2013 Osijek Montpellier \u2013 Narbonne \u2013 Perpignan \u2013 Barcelona \u2013 Valencia \u2013 M\u00e1laga \u2013 Tarifa with an extension to Narbonne \u2013 Toulouse Deployment of backbone networks, including with submarine cables Submarine cable networks Lisboa \u2013 Marseille \u2013 Milano Core network corridor \u201cNorth Sea \u2013 Baltic\u201d Cross-border sections for CAM experimentation Warszawa \u2013 Kaunas \u2013 Vilnius Kaunas \u2013 Klaip\u0117da More extensive section for larger scale deployment of CAM Tallinn \u2013R\u012bga \u2013 Kaunas \u2013 LT/PL border \u2013Warszawa BY/LT border \u2013 Vilnius \u2013 Kaunas \u2013 Klaip\u0117da Via Carpathia: Klaip\u0117da \u2013 Kaunas \u2013 E\u0142k \u2013 Bia\u0142ystok \u2013 Lublin \u2013 Rzesz\u00f3w \u2013 Barwinek \u2013 Ko\u0161ice Core network corridor \u201cNorth Sea \u2013 Mediterranean\u201d Cross-border sections for CAM experimentation Metz \u2013 Merzig \u2013 Luxembourg Rotterdam \u2013 Antwerp \u2013 Eindhoven More extensive section for larger scale deployment of CAM Amsterdam \u2013 Rotterdam \u2013 Breda \u2013 Lille \u2013 Paris Brussel or Bruxelles \u2013 Metz \u2013 Basel Mulhouse \u2013 Lyon \u2013 Marseille Core network corridor \u201cOrient/East-Med\u201d Cross-border sections for CAM experimentation Sofia \u2013 Thessaloniki \u2013 Beograd More extensive section for larger scale deployment of CAM Berlin \u2013 Praha \u2013 Brno \u2013 Bratislava \u2013 Timi\u015foara \u2013 Sofia \u2013 TR border Bratislava \u2013 Ko\u0161ice Sofia \u2013 Thessaloniki \u2013 Athina Core network corridor \u201cRhine \u2013 Alpine\u201d Cross-border sections for CAM experimentation Bologna \u2013 Innsbruck \u2013 M\u00fcnchen (Brenner corridor) More extensive section for larger scale deployment of CAM Rotterdam \u2013 Oberhausen \u2013 Frankfurt am Main Basel \u2013 Milano \u2013 Genova Core network corridor \u201cRhine \u2013 Danube\u201d Cross-border sections for CAM experimentation More extensive section for larger scale deployment of CAM Frankfurt am Main \u2013 Passau \u2013 Wien \u2013 Bratislava \u2013 Budapest \u2013 Osijek \u2013 Vukovar \u2013 Bucure\u0219ti \u2013 Constanta Bucure\u0219ti \u2013 Iasi Karlsruhe \u2013 M\u00fcnchen \u2013 Salzburg \u2013 Wels Frankfurt am Main \u2013 Strasbourg Core network corridor \u201cScandinavian \u2013 Mediterranean\u201d Cross-border sections for CAM experimentation Oulu \u2013 Troms\u00f8 Oslo \u2013 Stockholm \u2013 Helsinki More extensive section for larger scale deployment of CAM Turku \u2013 Helsinki \u2013 RU border Oslo \u2013 Malm\u00f6 \u2013 K\u00f8benhavn \u2013 Hamburg \u2013 W\u00fcrzburg \u2013 N\u00fcrnberg \u2013 M\u00fcnchen \u2013 Rosenheim \u2013 Verona \u2013 Bologna \u2013 Napoli \u2013 Catania \u2013 Palermo Stockholm \u2013 Malm\u00f6 Napoli \u2013 Bari \u2013 Taranto Aarhus \u2013 Esbjerg \u2013 Padborg (1) EUR 1 384 000 000 in 2018 prices. (2) Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1). (3) Sections in italics are located outside of the TEN-T core network corridors but included in the 5G corridors.", "summary": "Connecting Europe Facility (2021-2027) Connecting Europe Facility (2021-2027) SUMMARY OF: Regulation (EU) 2021/1153 establishing the Connecting Europe Facility WHAT IS THE AIM OF THE REGULATION? For the period of the multiannual financial framework (MFF) 2021-2027, the regulation: establishes the Connecting Europe Facility for 2021-2027 (CEF 2.0); sets out its objectives and budget; and outlines forms of European Union (EU) funding and eligibility rules. KEY POINTS Objectives CEF 2.0 has similar objectives to CEF 1.0 (which related to the period 2014-2020), but with a greater emphasis on: sustainability, decarbonisation and lower emissions; the complementarity of transport modes (as well as synergies between the transport, energy and digital sectors); improving military mobility across the EU. The general objective of CEF 2.0 is to build, develop, modernise and complete the trans-European networks in the transport, energy and digital sectors and facilitate international cooperation in the field of renewable energy, specifically contributing to the following 3 areas. Transport Efficient, interconnected and multimodal Trans-European Transport Networks (TEN-T), and infrastructure projects for smart, interoperable, sustainable, inclusive, accessible, safe and secure mobility. Adapting parts of the TEN-T infrastructure to improve both civilian and military mobility (subject to specific eligibility rules). Energy Facilitating cross-border energy cooperation, including renewable energy. Development of projects of common interests relating to further integration of an internal energy market, interoperability of networks across borders and sectors, facilitating decarbonisation of the economy, promoting energy efficiency and ensuring security of supply. Digital sector Deployment of and access to safe and secure very high-capacity networks, including 5G systems providing Gigabit connectivity in areas where socioeconomic drivers are located. Uninterrupted 5G coverage of major transport paths, including the TEN-T. Increased resilience and capacity of EU digital backbone networks by linking to neighbouring territories. Digitalisation of transport and energy networks. Budget (at 2021 prices) Transport: \u20ac25.81 billion (including \u20ac11.29 billion transferred from the Cohesion Fund). Energy: \u20ac5.84 billion. Digital: \u20ac2.07 billion. The CEF provides funding in the form of grants and procurement. Proposals are submitted by one or more EU Member States or, with the agreement of the Member States concerned, by international organisations, joint undertakings, or by public or private undertakings or bodies, including regional or local authorities. Non-EU country eligibility The following non-EU countries can participate in the CEF, under certain conditions: members of the European Free Trade Association which are also members of the European Economic Area; acceding countries, candidate countries and potential candidates; European neighbourhood policy countries; other non-EU countries, by specific agreement. Co-financing For most transport projects, EU financial support does not exceed 30% of the total eligible cost, increased up to 50% for studies, for the more prioritised actions and the civilian-defence dual-use actions, and up to 85% for projects where funds are transferred from the Cohesion Fund. For energy projects, the EU financial support does not exceed 50% of the total eligible cost, increased up to 75% for projects providing a high degree of regional or EU-wide security of supply, strengthening EU solidarity or offering highly innovative solutions. For digital projects, the EU financial support does not exceed 30% of the total eligible cost, increased up to 50% for actions with strong cross-border dimension and up to 75% for Gigabit connectivity for socioeconomic drivers. In each of the transport, energy and digital sectors, as regards works undertaken in the outermost regions, a specific maximum co-funding rate of 70% shall apply. To support synergies between the transport, energy and digital sectors, actions to achieve objectives in at least 2 of these sectors can receive a higher co-funding rate in compliance with a work programme addressing at least 2 of these sectors. The regulation repeals Regulations (EU) No 1316/2013 and (EU) No 283/2014. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND See also: European Climate, Infrastructure and Environment Executive Agency (European Commission) Mobility strategy (European Commission) European Health and Digital Executive Agency (Europa). MAIN DOCUMENT Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (OJ L 249, 14.7.2021, pp. 38-81) RELATED DOCUMENTS Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, pp. 159-706) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, pp. 1-34) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, pp. 82-209) Successive amendments to Directive (EU) 2018/2001 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, pp. 1-77) See consolidated version. Joint communication to the European Parliament and the Council \u2014 Improving military mobility in the European Union (JOIN(2017) 41 final, 10.11.2017) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 Europe on the move: An agenda for a socially fair transition towards clean, competitive and connected mobility for all (COM(2017) 283 final, 31.5.2017) Regulation (EU) No 1315/2013 of the European Parliament and of the Council on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, pp. 1-128) See consolidated version. Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (OJ L 115, 25.4.2013, pp. 39-75) See consolidated version. last update 17.09.2021"}
{"article": "17.5.2021 EN Official Journal of the European Union L 172/79 REGULATION (EU) 2021/784 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2021 on addressing the dissemination of terrorist content online (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) This Regulation aims to ensure the smooth functioning of the digital single market in an open and democratic society, by addressing the misuse of hosting services for terrorist purposes and contributing to public security across the Union. The functioning of the digital single market should be improved by reinforcing legal certainty for hosting service providers and users\u2019 trust in the online environment, as well as by strengthening safeguards to the freedom of expression, including the freedom to receive and impart information and ideas in an open and democratic society and the freedom and pluralism of the media. (2) Regulatory measures to address the dissemination of terrorist content online should be complemented by Member State strategies to address terrorism, including the strengthening of media literacy and critical thinking, the development of alternative and counter narratives, and other initiatives to reduce the impact of and vulnerability to terrorist content online, as well as investment in social work, deradicalisation initiatives and engagement with affected communities, in order to achieve the sustained prevention of radicalisation in society. (3) Addressing terrorist content online, which is part of a broader problem of illegal content online, requires a combination of legislative, non-legislative and voluntary measures based on collaboration between authorities and hosting service providers, in a manner that fully respects fundamental rights. (4) Hosting service providers active on the internet play an essential role in the digital economy by connecting business and citizens and by facilitating public debate and the distribution and receipt of information, opinions and ideas, contributing significantly to innovation, economic growth and job creation in the Union. However, the services of hosting service providers are in certain cases abused by third parties for the purpose of carrying out illegal activities online. Of particular concern is the misuse of those services by terrorist groups and their supporters to disseminate terrorist content online in order to spread their message, to radicalise and recruit followers, and to facilitate and direct terrorist activity. (5) While not the only factor, the presence of terrorist content online has proven to be a catalyst for the radicalisation of individuals which can lead to terrorist acts, and therefore has serious negative consequences for users, citizens and society at large as well as for the online service providers hosting such content, since it undermines the trust of their users and damages their business models. In light of their central role and the technological means and capabilities associated with the services they provide, hosting service providers have particular societal responsibilities to protect their services from misuse by terrorists and to help address terrorist content disseminated through their services online, while taking into account the fundamental importance of the freedom of expression, including the freedom to receive and impart information and ideas in an open and democratic society. (6) Efforts at Union level to counter terrorist content online commenced in 2015 through a framework of voluntary cooperation between Member States and hosting service providers. Those efforts need to be complemented by a clear legislative framework in order to further reduce the accessibility of terrorist content online and adequately address a rapidly evolving problem. The legislative framework seeks to build on voluntary efforts, which were reinforced by Commission Recommendation (EU) 2018/334 (3), and responds to calls made by the European Parliament to strengthen measures to address illegal and harmful content online in line with the horizontal framework established by Directive 2000/31/EC of the European Parliament and of the Council (4), as well as by the European Council to improve the detection and removal of content online that incites terrorist acts. (7) This Regulation should not affect the application of Directive 2000/31/EC. In particular, any measures taken by a hosting service provider in compliance with this Regulation, including any specific measures, should not in themselves lead to that hosting service provider losing the benefit of the liability exemption provided for in that Directive. Moreover, this Regulation does not affect the powers of national authorities and courts to establish the liability of hosting service providers where the conditions set out in that Directive for liability exemption are not met. (8) In the event of a conflict between this Regulation and Directive 2010/13/EU of the European Parliament and of the Council (5) in relation to provisions governing audiovisual media services as defined in point (a) of Article 1(1) of that Directive, Directive 2010/13/EU should prevail. This should leave the obligations under this Regulation, in particular with regard to video-sharing platform providers, unaffected. (9) This Regulation should set out rules to address the misuse of hosting services for the dissemination of terrorist content online in order to guarantee the smooth functioning of the internal market. Those rules should fully respect the fundamental rights protected in the Union and, in particular, those guaranteed by the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019). (10) This Regulation seeks to contribute to the protection of public security while establishing appropriate and robust safeguards to ensure the protection of fundamental rights, including the right to respect for private life, to the protection of personal data, to freedom of expression, including the freedom to receive and impart information, the freedom to conduct a business, and to an effective remedy. Moreover, any discrimination is prohibited. Competent authorities and hosting service providers should only adopt measures which are necessary, appropriate and proportionate within a democratic society, taking into account the particular importance accorded to the freedom of expression and information and the freedom and pluralism of the media, which constitute the essential foundations of a pluralist and democratic society and are values on which the Union is founded. Measures affecting the freedom of expression and information should be strictly targeted to address the dissemination of terrorist content online, while respecting the right to lawfully receive and impart information, taking into account the central role of hosting service providers in facilitating public debate and the distribution and receipt of facts, opinions and ideas, in accordance with the law. Effective online measures to address terrorist content online and the protection of freedom of expression and information are not conflicting but complementary and mutually reinforcing goals. (11) In order to provide clarity about the actions that both hosting service providers and competent authorities are to take to address the dissemination of terrorist content online, this Regulation should establish a definition of \u2018terrorist content\u2019 for preventative purposes, consistent with the definitions of relevant offences under Directive (EU) 2017/541 of the European Parliament and of the Council (6). Given the need to address the most harmful terrorist propaganda online, that definition should cover material that incites or solicits someone to commit, or to contribute to the commission of, terrorist offences, solicits someone to participate in activities of a terrorist group, or glorifies terrorist activities including by disseminating material depicting a terrorist attack. The definition should also include material that provides instruction on the making or use of explosives, firearms or other weapons or noxious or hazardous substances, as well as chemical, biological, radiological and nuclear (CBRN) substances, or on other specific methods or techniques, including the selection of targets, for the purpose of committing or contributing to the commission of terrorist offences. Such material includes text, images, sound recordings and videos, as well as live transmissions of terrorist offences, that cause a danger of further such offences being committed. When assessing whether material constitutes terrorist content within the meaning of this Regulation, competent authorities and hosting service providers should take into account factors such as the nature and wording of statements, the context in which the statements were made and their potential to lead to harmful consequences in respect of the security and safety of persons. The fact that the material was produced by, is attributable to or is disseminated on behalf of a person, group or entity included in the Union list of persons, groups and entities involved in terrorist acts and subject to restrictive measures should constitute an important factor in the assessment. (12) Material disseminated for educational, journalistic, artistic or research purposes or for awareness-raising purposes against terrorist activity should not be considered to be terrorist content. When determining whether the material provided by a content provider constitutes \u2018terrorist content\u2019 as defined in this Regulation, account should be taken, in particular, of the right to freedom of expression and information, including the freedom and pluralism of the media, and the freedom of the arts and sciences. Especially in cases where the content provider holds editorial responsibility, any decision as to the removal of the disseminated material should take into account the journalistic standards established by press or media regulation in accordance with Union law, including the Charter. Furthermore, the expression of radical, polemic or controversial views in the public debate on sensitive political questions should not be considered to be terrorist content. (13) In order to effectively address the dissemination of terrorist content online, while ensuring respect for the private life of individuals, this Regulation should apply to providers of information society services which store and disseminate to the public information and material provided by a user of the service on request, irrespective of whether the storing and dissemination to the public of such information and material is of a mere technical, automatic and passive nature. The concept of \u2018storage\u2019 should be understood as holding data in the memory of a physical or virtual server. Providers of \u2018mere conduit\u2019 or \u2018caching\u2019 services, as well as of other services provided in other layers of the internet infrastructure, which do not involve storage, such as registries and registrars, as well as providers of domain name systems (DNS), payment or distributed denial of service (DdoS) protection services, should therefore fall outside the scope of this Regulation. (14) The concept of \u2018dissemination to the public\u2019 should entail the making available of information to a potentially unlimited number of persons, namely making the information easily accessible to users in general, without requiring further action by the content provider, irrespective of whether those persons actually access the information in question. Accordingly, where access to information requires registration or admittance to a group of users, that information should be considered to be disseminated to the public only where users seeking to access the information are automatically registered or admitted without a human decision or selection of whom to grant access. Interpersonal communication services, as defined in point (5) of Article 2 of Directive (EU) 2018/1972 of the European Parliament and of the Council (7), such as emails or private messaging services, should fall outside the scope of this Regulation. Information should be considered to be stored and disseminated to the public within the meaning of this Regulation only where such activities are performed upon direct request of the content provider. Consequently, providers of services, such as cloud infrastructure, which are provided at the request of parties other than the content providers and only indirectly benefit the latter, should not be covered by this Regulation. This Regulation should cover, for example, providers of social media, video, image and audio-sharing services, as well as file-sharing services and other cloud services, insofar as those services are used to make the stored information available to the public at the direct request of the content provider. Where a hosting service provider offers several services, this Regulation should apply only to the services that fall within its scope. (15) Terrorist content is often disseminated to the public through services provided by hosting service providers established in third countries. In order to protect users in the Union and to ensure that all hosting service providers operating in the digital single market are subject to the same requirements, this Regulation should apply to all providers of relevant services offered in the Union, irrespective of the country of their main establishment. A hosting service provider should be considered offering services in the Union if it enables natural or legal persons in one or more Member States to use its services and has a substantial connection to that Member State or those Member States. (16) A substantial connection to the Union should exist where the hosting service provider has an establishment in the Union, its services are used by a significant number of users in one or more Member States, or its activities are targeted towards one or more Member States. The targeting of activities towards one or more Member States should be determined on the basis of all relevant circumstances, including factors such as the use of a language or a currency generally used in the Member State concerned, or the possibility of ordering goods or services from such Member State. Such targeting could also be derived from the availability of an application in the relevant national application store, from providing local advertising or advertising in a language generally used in the Member State concerned, or from the handling of customer relations such as by providing customer service in a language generally used in that Member State. A substantial connection should also be assumed where a hosting service provider directs its activities towards one or more Member States as set out in point (c) of Article 17(1) of Regulation (EU) No 1215/2012 of the European Parliament and of the Council (8). The mere accessibility of a hosting service provider\u2019s website, of an email address or of other contact details in one or more Member States, taken in isolation, should not be sufficient to constitute a substantial connection. Moreover, the provision of a service with a view to mere compliance with the prohibition of discrimination laid down in Regulation (EU) 2018/302 of the European Parliament and of the Council (9) should not, on that ground alone, be considered to constitute a substantial connection to the Union. (17) The procedure and obligations resulting from removal orders requiring hosting service providers to remove or disable access to terrorist content, following an assessment by the competent authorities, should be harmonised. Given the speed at which terrorist content is disseminated across online services, an obligation should be imposed on hosting service providers to ensure that the terrorist content identified in the removal order is removed or access to it is disabled in all Member States within one hour of receipt of the removal order. Except for in duly justified cases of emergency, the competent authority should provide the hosting service provider with information on procedures and applicable deadlines at least 12 hours in advance of issuing for the first time a removal order to that hosting service provider. Duly justified cases of emergency occur where the removal of or disabling of access to the terrorist content later than one hour after receipt of the removal order would result in serious harm, such as in situations of an imminent threat to the life or physical integrity of a person, or when such content depicts ongoing events resulting in harm to the life or physical integrity of a person. The competent authority should determine whether cases constitute emergency cases and duly justify its decision in the removal order. Where the hosting service provider cannot comply with the removal order within one hour of its receipt, on grounds of force majeure or de facto impossibility, including for objectively justifiable technical or operational reasons, it should inform the issuing competent authority as soon as possible and comply with the removal order as soon as the situation is resolved. (18) The removal order should contain a statement of reasons qualifying the material to be removed or access to which is to be disabled as terrorist content and provide sufficient information for the location of that content, by indicating the exact URL and, where necessary, any other additional information, such as a screenshot of the content in question. That statement of reasons should allow the hosting service provider and, ultimately, the content provider to effectively exercise their right to judicial redress. The reasons provided should not imply the disclosure of sensitive information which could jeopardise ongoing investigations. (19) The competent authority should submit the removal order directly to the contact point designated or established by the hosting service provider for the purposes of this Regulation by any electronic means capable of producing a written record under conditions that allow the hosting service provider to establish the authenticity of the order, including the accuracy of the date and the time of sending and receipt thereof, such as by secured email or platforms or other secured channels, including those made available by the hosting service provider, in accordance with Union law on the protection of personal data. It should be possible for that requirement to be met through the use of, inter alia, qualified electronic registered delivery services as provided for by Regulation (EU) No 910/2014 of the European Parliament and of the Council (10). Where the hosting service provider\u2019s main establishment is or its legal representative resides or is established in a Member State other than that of the issuing competent authority, a copy of the removal order should be submitted simultaneously to the competent authority of that Member State. (20) It should be possible for the competent authority of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established to scrutinise the removal order issued by competent authorities of another Member State to determine whether it seriously or manifestly infringes this Regulation or the fundamental rights enshrined in the Charter. Both the content provider and the hosting service provider should have the right to request such scrutiny by the competent authority in the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established. Where such a request is made, that competent authority should adopt a decision on whether the removal order comprises such an infringement. Where that decision finds such an infringement, the removal order should cease to have legal effects. The scrutiny should be carried out swiftly so as to ensure that erroneously removed or disabled content is reinstated as soon as possible. (21) Hosting service providers that are exposed to terrorist content should, where they have terms and conditions, include therein provisions to address the misuse of their services for the dissemination to the public of terrorist content. They should apply those provisions in a diligent, transparent, proportionate and non-discriminatory manner. (22) Given the scale of the problem and the speed necessary to effectively identify and remove terrorist content, effective and proportionate specific measures are an essential element in addressing terrorist content online. With a view to reducing the accessibility of terrorist content on their services, hosting service providers exposed to terrorist content should put in place specific measures taking into account the risks and level of exposure to terrorist content as well as the effects on the rights of third parties and the public interest to information. Hosting service providers should determine what appropriate, effective and proportionate specific measure should be put in place to identify and remove terrorist content. Specific measures could include appropriate technical or operational measures or capacities such as staffing or technical means to identify and expeditiously remove or disable access to terrorist content, mechanisms for users to report or flag alleged terrorist content, or any other measures the hosting service provider considers appropriate and effective to address the availability of terrorist content on its services. (23) When putting in place specific measures, hosting service providers should ensure that users\u2019 right to freedom of expression and information as well as the freedom and pluralism of the media as protected under the Charter are preserved. In addition to any requirement laid down in the law, including legislation on the protection of personal data, hosting service providers should act with due diligence and implement safeguards, where appropriate, including human oversight and verifications, to avoid any unintended or erroneous decision leading to the removal of or disabling of access to content that is not terrorist content. (24) The hosting service provider should report to the competent authority on the specific measures in place in order to allow that authority to determine whether the measures are effective and proportionate and whether, if automated means are used, the hosting service provider has the necessary capacity for human oversight and verification. In assessing the effectiveness and proportionality of the measures, competent authorities should take into account relevant parameters, including the number of removal orders issued to the hosting service provider, the size and economic capacity of the hosting service provider and the impact of its services in disseminating terrorist content, for example on the basis of the number of users in the Union, as well as the safeguards put in place to address the misuse of its services for the dissemination of terrorist content online. (25) Where the competent authority considers that the specific measures put in place are insufficient to address the risks, it should be able to require the adoption of additional appropriate, effective and proportionate specific measures. The requirement to implement such additional specific measures should not lead to a general obligation to monitor or to engage in active fact-finding within the meaning of Article 15(1) of Directive 2000/31/EC or to an obligation to use automated tools. However, it should be possible for hosting service providers to use automated tools if they consider this to be appropriate and necessary to effectively address the misuse of their services for the dissemination of terrorist content. (26) The obligation on hosting service providers to preserve removed content and related data should be laid down for specific purposes and limited to the period necessary. There is a need to extend the preservation requirement to related data to the extent that any such data would otherwise be lost as a consequence of the removal of the terrorist content in question. Related data can include data such as subscriber data, in particular data pertaining to the identity of the content provider, as well as access data, including data about the date and time of use by the content provider and the log-in to and log-off from the service, together with the IP address allocated by the internet access service provider to the content provider. (27) The obligation to preserve the content for administrative or judicial review proceedings is necessary and justified in view of the need to ensure that effective remedies are in place for content providers whose content has been removed or access to which has been disabled, as well as to ensure the reinstatement of that content, depending on the outcome of those proceedings. The obligation to preserve material for investigative or prosecutorial purposes is justified and necessary in view of the value the material could have for the purpose of disrupting or preventing terrorist activity. Therefore, the preservation of removed terrorist content for the purposes of prevention, detection, investigation and prosecution of terrorist offences should also be considered to be justified. The terrorist content and the related data should be stored only for the period necessary to allow the law enforcement authorities to check that terrorist content and decide whether it would be needed for those purposes. For the purposes of the prevention, detection, investigation and prosecution of terrorist offences, the required preservation of data should be limited to data that are likely to have a link with terrorist offences, and could therefore contribute to prosecuting terrorist offences or to preventing serious risks to public security. Where hosting service providers remove or disable access to material, in particular through their own specific measures, they should inform the competent authorities promptly of content that contains information involving an imminent threat to life or a suspected terrorist offence. (28) To ensure proportionality, the period of preservation should be limited to six months to allow content providers sufficient time to initiate administrative or judicial review proceedings and to enable access by law enforcement authorities to relevant data for the investigation and prosecution of terrorist offences. However, upon the request of the competent authority or court, it should be possible to extend that period for as long as necessary in cases where those proceedings are initiated but not finalised within that six-month period. The duration of the period of preservation should be sufficient to allow law enforcement authorities to preserve the necessary material in relation to investigations and prosecutions, while ensuring the balance with the fundamental rights. (29) This Regulation should not affect the procedural guarantees or procedural investigation measures related to access to content and related data preserved for the purposes of the investigation and prosecution of terrorist offences, as regulated under Union or national law. (30) The transparency of hosting service providers\u2019 policies in relation to terrorist content is essential to enhance their accountability towards their users and to reinforce trust of citizens in the digital single market. Hosting service providers that have taken action or were required to take action pursuant to this Regulation in a given calendar year should make publicly available annual transparency reports containing information about action taken in relation to the identification and removal of terrorist content. (31) The competent authorities should publish annual transparency reports containing information on the number of removal orders, the number of cases where an order was not executed, the number of decisions concerning specific measures, the number of cases subject to administrative or judicial review proceedings and the number of decisions imposing penalties. (32) The right to an effective remedy is enshrined in Article 19 of the Treaty on European Union (TEU) and in Article 47 of the Charter. Each natural or legal person has the right to an effective remedy before the competent national court against any of the measures taken pursuant to this Regulation which can adversely affect the rights of that person. That right should include, in particular, the possibility for hosting service providers and content providers to effectively challenge the removal orders or any decisions resulting from the scrutiny of removal orders under this Regulation before a court of the Member State whose competent authority issued the removal order or took the decision, as well as for hosting service providers to effectively challenge a decision relating to specific measures or penalties before a court of the Member State whose competent authority took that decision. (33) Complaint procedures constitute a necessary safeguard against the erroneous removal of or disabling of access to content online where such content is protected under the freedom of expression and information. Hosting service providers should therefore establish user-friendly complaint mechanisms and ensure that complaints are dealt with expeditiously and in full transparency towards the content provider. The requirement for the hosting service provider to reinstate content that has been removed or access to which has been disabled in error should not affect the possibility for the hosting service provider to enforce its own terms and conditions. (34) Effective legal protection in accordance with Article 19 TEU and Article 47 of the Charter requires that content providers are able to ascertain the reasons upon which the content they provide has been removed or access to which has been disabled. For that purpose, the hosting service provider should make available to the content provider information for challenging the removal or the disabling. Depending on the circumstances, hosting service providers could replace content which has been removed or access to which has been disabled with a message indicating that the content has been removed or access to it has been disabled in accordance with this Regulation. Further information about the reasons for the removal or disabling as well as the remedies for the removal or disabling should be provided upon request of the content provider. Where the competent authorities decide that for reasons of public security, including in the context of an investigation, it is inappropriate or counterproductive to directly notify the content provider of the removal or disabling, they should inform the hosting service provider accordingly. (35) For the purposes of this Regulation, Member States should designate competent authorities. This should not necessarily imply the establishment of a new authority and it should be possible to entrust an existing body with the functions provided for in this Regulation. This Regulation should require the designation of authorities competent for issuing removal orders, scrutinising removal orders, overseeing specific measures and imposing penalties, while it should be possible for each Member State to decide on the number of competent authorities to be designated and whether they are administrative, law enforcement or judicial. Member States should ensure that the competent authorities fulfil their tasks in an objective and non-discriminatory manner and do not seek or take instructions from any other body in relation to the exercise of the tasks under this Regulation. This should not prevent supervision in accordance with national constitutional law. Member States should communicate the competent authorities designated under this Regulation to the Commission, which should publish online a register listing the competent authorities. That online register should be easily accessible to facilitate the swift verification of the authenticity of removal orders by the hosting service providers. (36) In order to avoid duplication of effort and possible interferences with investigations and to minimise the burden to the hosting service providers affected, the competent authorities should exchange information, coordinate and cooperate with each other and, where appropriate, with Europol, before issuing removal orders. When deciding whether to issue a removal order, the competent authority should give due consideration to any notification of an interference with an investigative interest (deconfliction). Where a competent authority is informed by a competent authority of another Member State of an existing removal order, it should not issue a removal order concerning the same subject matter. In implementing the provisions of this Regulation, Europol could provide support in line with its current mandate and existing legal framework. (37) In order to ensure the effective and sufficiently coherent implementation of specific measures taken by hosting service providers, competent authorities should coordinate and cooperate with each other with regard to the exchanges with hosting service providers as to removal orders and the identification, implementation and assessment of specific measures. Coordination and cooperation are also needed in relation to other measures to implement this Regulation, including with respect to the adoption of rules on penalties and the imposition of penalties. The Commission should facilitate such coordination and cooperation. (38) It is essential that the competent authority of the Member State responsible for imposing penalties is fully informed of the issuing of removal orders and of the subsequent exchanges between the hosting service provider and the competent authorities in other Member States. For that purpose, Member States should ensure appropriate and secure communication channels and mechanisms allowing the sharing of relevant information in a timely manner. (39) To facilitate the swift exchanges between competent authorities as well as with hosting service providers, and to avoid duplication of effort, Member States should be encouraged to make use of the dedicated tools developed by Europol, such as the current internet Referral Management application or its successors. (40) Referrals by Member States and Europol have proven to be an effective and swift means of increasing hosting service providers\u2019 awareness of specific content available through their services and enabling them to take swift action. Such referrals, which are a mechanism for alerting hosting service providers of information that could be considered to be terrorist content for the provider\u2019s voluntary consideration of the compatibility of that content with its own terms and conditions, should remain available in addition to removal orders. The final decision on whether to remove the content because it is incompatible with its terms and conditions remains with the hosting service provider. This Regulation should not affect the mandate of Europol as laid down in Regulation (EU) 2016/794 of the European Parliament and of the Council (11). Therefore, nothing in this Regulation should be understood as precluding the Member States and Europol from using referrals as an instrument to address terrorist content online. (41) Given the particular serious consequences of certain terrorist content online, hosting service providers should promptly inform the relevant authorities in the Member State concerned or the competent authorities of the Member State where they are established or have a legal representative of terrorist content involving an imminent threat to life or a suspected terrorist offence. In order to ensure proportionality, that obligation should be limited to terrorist offences as defined in Article 3(1) of Directive (EU) 2017/541. That obligation to inform should not imply an obligation on hosting service providers to actively seek any evidence of such imminent threat to life or a suspected terrorist offence. The Member State concerned should be understood to be the Member State with jurisdiction over the investigation and prosecution of those terrorist offences based on the nationality of the offender or of the potential victim of the offence or the target location of the terrorist act. In the case of doubt, hosting service providers should submit the information to Europol, which should provide the relevant follow-up action in accordance with its mandate, including by forwarding that information to the relevant national authorities. The competent authorities of the Member States should be allowed to use such information to take investigatory measures available under Union or national law. (42) Hosting service providers should designate or establish contact points to facilitate the expeditious handling of removal orders. The contact point should serve only for operational purposes. The contact point should consist of any dedicated means, in-house or outsourced, allowing for the electronic submission of removal orders and of technical or personal means allowing for the expeditious processing thereof. It is not necessary that the contact point be located in the Union. The hosting service provider should be free to make use of an existing contact point for the purpose of this Regulation, provided that the contact point is able to fulfil the functions provided for in this Regulation. With a view to ensuring that terrorist content is removed or that access thereto is disabled within one hour of receipt of a removal order, the contact points of hosting service providers exposed to terrorist content should be accessible at any time. The information on the contact point should include information about the language in which it can be addressed. In order to facilitate the communication between the hosting service providers and the competent authorities, hosting service providers are encouraged to allow for communication in one of the official languages of the Union institutions in which their terms and conditions are available. (43) In the absence of a general requirement for hosting service providers to ensure a physical presence within the territory of the Union, there is a need to ensure clarity under which Member State\u2019s jurisdiction the hosting service provider offering services within the Union falls. As a general rule, the hosting service provider falls under the jurisdiction of the Member State in which it has its main establishment or in which its legal representative resides or is established. That should be without prejudice to the rules on competence established for the purpose of removal orders and decisions resulting from the scrutiny of removal orders under this Regulation. With regard to a hosting service provider which has no establishment in the Union and does not designate a legal representative, any Member State should, nevertheless, have jurisdiction and therefore be able to impose penalties, provided that the principle of ne bis in idem is respected. (44) Hosting service providers that are not established in the Union should designate in writing a legal representative in order to ensure compliance with and the enforcement of the obligations under this Regulation. It should be possible for hosting service providers to designate, for the purposes of this Regulation, a legal representative already designated for other purposes, provided that that legal representative is able to fulfil the functions provided for in this Regulation. The legal representative should be empowered to act on behalf of the hosting service provider. (45) Penalties are necessary to ensure the effective implementation of this Regulation by hosting service providers. Member States should adopt rules on penalties, which can be of an administrative or criminal nature, as well as, where appropriate, fining guidelines. Non-compliance in individual cases could be subject to penalties while respecting the principles of ne bis in idem and of proportionality and ensuring that such penalties take account of systematic failure. Penalties could take different forms, including formal warnings in the case of minor infringements or financial penalties in relation to more severe or systematic infringements. Particularly severe penalties should be imposed in the event that the hosting service provider systematically or persistently fails to remove or disable access to terrorist content within one hour of receipt of a removal order. In order to ensure legal certainty, this Regulation should set out which infringements are subject to penalties and which circumstances are relevant for assessing the type and level of such penalties. When determining whether to impose financial penalties, due account should be taken of the financial resources of the hosting service provider. Moreover, the competent authority should take into account whether the hosting service provider is a start-up or a micro, small or medium-sized enterprise as defined in Commission Recommendation 2003/361/EC (12). Additional circumstances, such as whether the conduct of the hosting service provider was objectively imprudent or reprehensible or whether the infringement has been committed negligently or intentionally, should be taken into account. Member States should ensure that penalties imposed for the infringement of this Regulation do not encourage the removal of material which is not terrorist content. (46) The use of standardised templates facilitates cooperation and the exchange of information between competent authorities and hosting service providers, allowing them to communicate more quickly and effectively. It is particularly important to ensure expeditious action following the receipt of a removal order. Templates reduce translation costs and contribute to a higher standard of the process. Feedback templates allow for a standardised exchange of information and are particularly important where hosting service providers are unable to comply with removal orders. Authenticated submission channels can guarantee the authenticity of the removal order, including the accuracy of the date and the time of sending and receipt of the order. (47) In order to allow for a swift amendment, where necessary, of the content of the templates to be used for the purposes of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the annexes to this Regulation. In order to be able to take into account the development of technology and of the related legal framework, the Commission should also be empowered to adopt delegated acts to supplement this Regulation with technical requirements for the electronic means to be used by competent authorities for the transmission of removal orders. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (48) Member States should collect information on the implementation of this Regulation. It should be possible for Member States to make use of the hosting service providers\u2019 transparency reports and complement them, where necessary, with more detailed information, such as their own transparency reports pursuant to this Regulation. A detailed programme for monitoring the outputs, results and impacts of this Regulation should be established in order to inform an evaluation of the implementation of this Regulation. (49) Based on the findings and conclusions in the implementation report and the outcome of the monitoring exercise, the Commission should carry out an evaluation of this Regulation within three years of the date of its entry into force. The evaluation should be based on the criteria of efficiency, necessity, effectiveness, proportionality, relevance, coherence and Union added value. It should assess the functioning of the different operational and technical measures provided for by this Regulation, including the effectiveness of measures to enhance the detection, identification and removal of terrorist content online, the effectiveness of safeguard mechanisms as well as the impacts on potentially affected fundamental rights, such as the freedom of expression and information, including the freedom and pluralism of the media, the freedom to conduct a business, the right to private life and the protection of personal data. The Commission should also assess the impact on potentially affected interests of third parties. (50) Since the objective of this Regulation, namely ensuring the smooth functioning of the digital single market by addressing the dissemination of terrorist content online, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: SECTION I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation lays down uniform rules to address the misuse of hosting services for the dissemination to the public of terrorist content online, in particular on: (a) reasonable and proportionate duties of care to be applied by hosting service providers in order to address the dissemination to the public of terrorist content through their services and ensure, where necessary, the expeditious removal of or disabling of access to such content; (b) the measures to be put in place by Member States, in accordance with Union law and subject to suitable safeguards to protect fundamental rights, in particular the freedom of expression and information in an open and democratic society, in order to: (i) identify and ensure the expeditious removal of terrorist content by hosting service providers; and (ii) facilitate cooperation among the competent authorities of Member States, hosting service providers and, where appropriate, Europol. 2. This Regulation applies to hosting service providers offering services in the Union, irrespective of their place of main establishment, insofar as they disseminate information to the public. 3. Material disseminated to the public for educational, journalistic, artistic or research purposes or for the purposes of preventing or countering terrorism, including material which represents an expression of polemic or controversial views in the course of public debate, shall not be considered to be terrorist content. An assessment shall determine the true purpose of that dissemination and whether material is disseminated to the public for those purposes. 4. This Regulation shall not have the effect of modifying the obligation to respect the rights, freedoms and principles referred to in Article 6 TEU and shall apply without prejudice to fundamental principles relating to freedom of expression and information, including freedom and pluralism of the media. 5. This Regulation shall be without prejudice to Directives 2000/31/EC and 2010/13/EU. For audiovisual media services as defined in point (a) of Article 1(1) of Directive 2010/13/EU, Directive 2010/13/EU shall prevail. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018hosting service provider\u2019 means a provider of services as defined in point (b) of Article 1 of Directive (EU) 2015/1535 of the European Parliament and of the Council (14), consisting of the storage of information provided by and at the request of a content provider; (2) \u2018content provider\u2019 means a user that has provided information that is, or that has been, stored and disseminated to the public by a hosting service provider; (3) \u2018dissemination to the public\u2019 means the making available of information, at the request of a content provider, to a potentially unlimited number of persons; (4) \u2018offering services in the Union\u2019 means enabling natural or legal persons in one or more Member States to use the services of a hosting service provider which has a substantial connection to that Member State or those Member States; (5) \u2018substantial connection\u2019 means the connection of a hosting service provider with one or more Member States resulting either from its establishment in the Union or from specific factual criteria, such as: (a) having a significant number of users of its services in one or more Member States; or (b) the targeting of its activities to one or more Member States; (6) \u2018terrorist offences\u2019 means offences as defined in Article 3 of Directive (EU) 2017/541; (7) \u2018terrorist content\u2019 means one or more of the following types of material, namely material that: (a) incites the commission of one of the offences referred to in points (a) to (i) of Article 3(1) of Directive (EU) 2017/541, where such material, directly or indirectly, such as by the glorification of terrorist acts, advocates the commission of terrorist offences, thereby causing a danger that one or more such offences may be committed; (b) solicits a person or a group of persons to commit or contribute to the commission of one of the offences referred to in points (a) to (i) of Article 3(1) of Directive (EU) 2017/541; (c) solicits a person or a group of persons to participate in the activities of a terrorist group, within the meaning of point (b) of Article 4 of Directive (EU) 2017/541; (d) provides instruction on the making or use of explosives, firearms or other weapons or noxious or hazardous substances, or on other specific methods or techniques for the purpose of committing or contributing to the commission of one of the terrorist offences referred to in points (a) to (i) of Article 3(1) of Directive (EU) 2017/541; (e) constitutes a threat to commit one of the offences referred to in points (a) to (i) of Article 3(1) of Directive (EU) 2017/541; (8) \u2018terms and conditions\u2019 means all terms, conditions and clauses, irrespective of their name or form, which govern the contractual relationship between a hosting service provider and its users; (9) \u2018main establishment\u2019 means the head office or registered office of the hosting service provider within which the principal financial functions and operational control are exercised. SECTION II MEASURES TO ADDRESS THE DISSEMINATION OF TERRORIST CONTENT ONLINE Article 3 Removal orders 1. The competent authority of each Member State shall have the power to issue a removal order requiring hosting service providers to remove terrorist content or to disable access to terrorist content in all Member States. 2. Where a competent authority has not previously issued a removal order to a hosting service provider, it shall provide that hosting service provider with information on the applicable procedures and deadlines, at least 12 hours before issuing the removal order. The first subparagraph shall not apply in duly justified cases of emergency. 3. Hosting service providers shall remove terrorist content or disable access to terrorist content in all Member States as soon as possible and in any event within one hour of receipt of the removal order. 4. Competent authorities shall issue removal orders using the template set out in Annex I. Removal orders shall contain the following elements: (a) identification details of the competent authority issuing the removal order and authentication of the removal order by that competent authority; (b) a sufficiently detailed statement of reasons explaining why the content is considered to be terrorist content, and a reference to the relevant type of material referred to in point (7) of Article 2; (c) an exact uniform resource locator (URL) and, where necessary, additional information for the identification of the terrorist content; (d) a reference to this Regulation as the legal basis for the removal order; (e) the date, time stamp and electronic signature of the competent authority issuing the removal order; (f) easily understandable information about the redress available to the hosting service provider and to the content provider, including information about redress to the competent authority, recourse to a court, as well as the deadlines for appeal; (g) where necessary and proportionate, the decision not to disclose information about the removal of or disabling of access to terrorist content in accordance with Article 11(3). 5. The competent authority shall address the removal order to the main establishment of the hosting service provider or to its legal representative designated in accordance with Article 17. That competent authority shall transmit the removal order to the contact point referred to in Article 15(1) by electronic means capable of producing a written record under conditions that allow to establish the authentication of the sender, including the accuracy of the date and the time of sending and receipt of the order. 6. The hosting service provider shall, without undue delay, inform the competent authority, using the template set out in Annex II, of the removal of the terrorist content or the disabling of access to the terrorist content in all Member States, indicating, in particular, the time of that removal or disabling. 7. If the hosting service provider cannot comply with the removal order on grounds of force majeure or de facto impossibility not attributable to the hosting service provider, including for objectively justifiable technical or operational reasons, it shall, without undue delay, inform the competent authority that issued the removal order of those grounds, using the template set out in Annex III. The deadline set out in paragraph 3 shall start to run as soon as the grounds referred to in the first subparagraph of this paragraph have ceased to exist. 8. If the hosting service provider cannot comply with the removal order because it contains manifest errors or does not contain sufficient information for its execution, it shall, without undue delay, inform the competent authority that issued the removal order and request the necessary clarification, using the template set out in Annex III. The deadline set out in paragraph 3 shall start to run as soon as the hosting service provider has received the necessary clarification. 9. A removal order shall become final upon the expiry of the deadline for appeal where no appeal has been lodged in accordance with national law or upon confirmation following an appeal. When the removal order becomes final, the competent authority that issued the removal order shall inform the competent authority referred to in point (c) of Article 12(1) of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established of that fact. Article 4 Procedure for cross-border removal orders 1. Subject to Article 3, where the hosting service provider does not have its main establishment or legal representative in the Member State of the competent authority that issued the removal order, that authority shall, simultaneously, submit a copy of the removal order to the competent authority of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established. 2. Where a hosting service provider receives a removal order as referred to in this Article, it shall take the measures provided for in Article 3 and take the necessary measures to be able to reinstate the content or access thereto, in accordance with paragraph 7 of this Article. 3. The competent authority of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established may, on its own initiative, within 72 hours of receiving the copy of the removal order in accordance with paragraph 1, scrutinise the removal order to determine whether it seriously or manifestly infringes this Regulation or the fundamental rights and freedoms guaranteed by the Charter. Where it finds an infringement, it shall, within the same period, adopt a reasoned decision to that effect. 4. Hosting service providers and content providers shall have the right to submit, within 48 hours of receiving either a removal order or information pursuant to Article 11(2), a reasoned request to the competent authority of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established to scrutinise the removal order as referred to in the first subparagraph of paragraph 3 of this Article. The competent authority shall, within 72 hours of receiving the request, adopt a reasoned decision following its scrutiny of the removal order, setting out its findings as to whether there is an infringement. 5. The competent authority shall, before adopting a decision pursuant to the second subparagraph of paragraph 3 or a decision finding an infringement pursuant to the second subparagraph of paragraph 4, inform the competent authority that issued the removal order of its intention to adopt the decision and of its reasons for doing so. 6. Where the competent authority of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established adopts a reasoned decision in accordance with paragraph 3 or 4 of this Article, it shall, without delay, communicate that decision to the competent authority that issued the removal order, the hosting service provider, the content provider who requested the scrutiny pursuant to paragraph 4 of this Article and, in accordance with Article 14, Europol. Where the decision finds an infringement pursuant to paragraph 3 or 4 of this Article, the removal order shall cease to have legal effects. 7. Upon receiving a decision finding an infringement communicated in accordance with paragraph 6, the hosting service provider concerned shall immediately reinstate the content or access thereto, without prejudice to the possibility to enforce its terms and conditions in accordance with Union and national law. Article 5 Specific measures 1. A hosting service provider exposed to terrorist content as referred to in paragraph 4 shall, where applicable, include in its terms and conditions and apply provisions to address the misuse of its services for the dissemination to the public of terrorist content. It shall do so in a diligent, proportionate and non-discriminatory manner, with due regard, in all circumstances, to the fundamental rights of the users and taking into account, in particular, the fundamental importance of the freedom of expression and information in an open and democratic society, with a view to avoiding the removal of material which is not terrorist content. 2. A hosting service provider exposed to terrorist content as referred to in paragraph 4 shall take specific measures to protect its services against the dissemination to the public of terrorist content. The decision as to the choice of specific measures shall remain with the hosting service provider. Such measures may include one or more of the following: (a) appropriate technical and operational measures or capacities, such as appropriate staffing or technical means to identify and expeditiously remove or disable access to terrorist content; (b) easily accessible and user-friendly mechanisms for users to report or flag to the hosting service provider alleged terrorist content; (c) any other mechanisms to increase the awareness of terrorist content on its services, such as mechanisms for user moderation; (d) any other measure that the hosting service provider considers to be appropriate to address the availability of terrorist content on its services. 3. Specific measures shall meet all of the following requirements: (a) they shall be effective in mitigating the level of exposure of the services of the hosting service provider to terrorist content; (b) they shall be targeted and proportionate, taking into account, in particular, the seriousness of the level of exposure of the services of the hosting service provider to terrorist content as well as the technical and operational capabilities, financial strength, the number of users of the services of the hosting service provider and the amount of content they provide; (c) they shall be applied in a manner that takes full account of the rights and legitimate interest of the users, in particular users\u2019 fundamental rights concerning freedom of expression and information, respect for private life and protection of personal data; (d) they shall be applied in a diligent and non-discriminatory manner. Where specific measures involve the use of technical measures, appropriate and effective safeguards, in particular through human oversight and verification, shall be provided to ensure accuracy and to avoid the removal of material that is not terrorist content. 4. A hosting service provider is exposed to terrorist content where the competent authority of the Member State of its main establishment or where its legal representative resides or is established has: (a) taken a decision, on the basis of objective factors, such as the hosting service provider having received two or more final removal orders in the previous 12 months, finding that the hosting service provider is exposed to terrorist content; and (b) notified the decision referred to in point (a) to the hosting service provider. 5. After having received a decision as referred to in paragraph 4 or, where relevant, paragraph 6, a hosting service provider shall report to the competent authority on the specific measures that it has taken and that it intends to take in order to comply with paragraphs 2 and 3. It shall do so within three months of receipt of the decision and on an annual basis thereafter. That obligation shall cease once the competent authority has decided, upon request pursuant to paragraph 7, that the hosting service provider is no longer exposed to terrorist content. 6. Where, based on the reports referred to in paragraph 5 and, where relevant, any other objective factors, the competent authority considers that the specific measures taken do not comply with paragraphs 2 and 3, that competent authority shall address a decision to the hosting service provider requiring it to take the necessary measures so as to ensure that paragraphs 2 and 3 are complied with. The hosting service provider may choose the type of specific measures to take. 7. A hosting service provider may, at any time, request the competent authority to review and, where appropriate, amend or revoke a decision as referred to in paragraph 4 or 6. The competent authority shall, within three months of receipt of the request, adopt a reasoned decision on the request based on objective factors and notify the hosting service provider of that decision. 8. Any requirement to take specific measures shall be without prejudice to Article 15(1) of Directive 2000/31/EC and shall entail neither a general obligation for hosting services providers to monitor the information which they transmit or store, nor a general obligation actively to seek facts or circumstances indicating illegal activity. Any requirement to take specific measures shall not include an obligation to use automated tools by the hosting service provider. Article 6 Preservation of content and related data 1. Hosting service providers shall preserve terrorist content which has been removed or access to which has been disabled as a result of a removal order, or of specific measures pursuant to Article 3 or 5, as well as any related data removed as a consequence of the removal of such terrorist content, which are necessary for: (a) administrative or judicial review proceedings or complaint-handling under Article 10 against a decision to remove or disable access to terrorist content and related data; or (b) the prevention, detection, investigation and prosecution of terrorist offences. 2. The terrorist content and related data, as referred to in paragraph 1, shall be preserved for six months from the removal or disabling. The terrorist content shall, upon request from the competent authority or court, be preserved for a further specified period only if and for as long as necessary for ongoing administrative or judicial review proceedings, as referred to in point (a) of paragraph 1. 3. Hosting service providers shall ensure that the terrorist content and related data preserved pursuant to paragraph 1 are subject to appropriate technical and organisational safeguards. Those technical and organisational safeguards shall ensure that the terrorist content and related data preserved are accessed and processed only for the purposes referred to in paragraph 1, and ensure a high level of security of the personal data concerned. Hosting service providers shall review and update those safeguards where necessary. SECTION III SAFEGUARDS AND ACCOUNTABILITY Article 7 Transparency obligations for hosting service providers 1. Hosting service providers shall set out clearly in their terms and conditions their policy for addressing the dissemination of terrorist content, including, where appropriate, a meaningful explanation of the functioning of specific measures, including, where applicable, the use of automated tools. 2. A hosting service provider that has taken action to address the dissemination of terrorist content or has been required to take action pursuant to this Regulation in a given calendar year, shall make publicly available a transparency report on those actions for that year. It shall publish that report before 1 March of the following year. 3. Transparency reports shall include at least the following information: (a) information about the hosting service provider\u2019s measures in relation to the identification and removal of or disabling of access to terrorist content; (b) information about the hosting service provider\u2019s measures to address the reappearance online of material which has previously been removed or to which access has been disabled because it was considered to be terrorist content, in particular where automated tools have been used; (c) the number of items of terrorist content removed or to which access has been disabled following removal orders or specific measures, and the number of removal orders where the content has not been removed or access to which has not been disabled pursuant to the first subparagraph of Article 3(7) and the first subparagraph of Article 3(8), together with the grounds therefor; (d) the number and the outcome of complaints handled by the hosting service provider in accordance with Article 10; (e) the number and the outcome of administrative or judicial review proceedings brought by the hosting service provider; (f) the number of cases in which the hosting service provider was required to reinstate content or access thereto as a result of administrative or judicial review proceedings; (g) the number of cases in which the hosting service provider reinstated content or access thereto following a complaint by the content provider. Article 8 Competent authorities\u2019 transparency reports 1. Competent authorities shall publish annual transparency reports on their activities under this Regulation. Those reports shall include at least the following information in relation to the given calendar year: (a) the number of removal orders issued under Article 3, specifying the number of removal orders subject to Article 4(1), the number of removal orders scrutinised under Article 4, and information on the implementation of those removal orders by the hosting service providers concerned, including the number of cases in which terrorist content was removed or access thereto was disabled and the number of cases in which terrorist content was not removed or access thereto was not disabled; (b) the number of decisions taken in accordance with Article 5(4), (6) or (7), and information on the implementation of those decisions by hosting service providers, including a description of the specific measures; (c) the number of cases in which removal orders and decisions taken in accordance with Article 5(4) and (6) were subject to administrative or judicial review proceedings and information on the outcome of the relevant proceedings; (d) the number of decisions imposing penalties pursuant to Article 18, and a description of the type of penalty imposed. 2. The annual transparency reports referred to in paragraph 1 shall not include information that may prejudice ongoing activities for the prevention, detection, investigation or prosecution of terrorist offences or interests of national security. Article 9 Remedies 1. Hosting service providers that have received a removal order issued pursuant to Article 3(1) or a decision pursuant to Article 4(4) or to Article 5(4), (6) or (7), shall have a right to an effective remedy. That right shall include the right to challenge such a removal order before the courts of the Member State of the competent authority that issued the removal order and the right to challenge the decision pursuant to Article 4(4) or to Article 5(4), (6) or (7), before the courts of the Member State of the competent authority that took the decision. 2. Content providers whose content has been removed or access to which has been disabled following a removal order shall have the right to an effective remedy. That right shall include the right to challenge a removal order issued pursuant to Article 3(1) before the courts of the Member State of the competent authority that issued the removal order and the right to challenge a decision pursuant to Article 4(4) before the courts of the Member State of the competent authority that took the decision. 3. Member States shall put in place effective procedures for exercising the rights referred to in this Article. Article 10 Complaint mechanisms 1. Each hosting service provider shall establish an effective and accessible mechanism allowing content providers where their content has been removed or access thereto has been disabled as a result of specific measures pursuant to Article 5 to submit a complaint concerning that removal or disabling, requesting the reinstatement of the content or of access thereto. 2. Each hosting service provider shall expeditiously examine all complaints that it receives through the mechanism referred to in paragraph 1 and reinstate the content or access thereto, without undue delay, where its removal or disabling of access thereto was unjustified. It shall inform the complainant of the outcome of the complaint within two weeks of the receipt thereof. Where the complaint is rejected, the hosting service provider shall provide the complainant with the reasons for its decision. A reinstatement of content or of access thereto shall not preclude administrative or judicial review proceedings challenging the decision of the hosting service provider or of the competent authority. Article 11 Information to content providers 1. Where a hosting service provider removes or disables access to terrorist content, it shall make available to the content provider information on such removal or disabling. 2. Upon request of the content provider, the hosting service provider shall either inform the content provider of the reasons for the removal or disabling and its rights to challenge the removal order or provide the content provider with a copy of the removal order. 3. The obligation pursuant to paragraphs 1 and 2 shall not apply where the competent authority issuing the removal order decides that it is necessary and proportionate that there be no disclosure for reasons of public security, such as the prevention, investigation, detection and prosecution of terrorist offences, for as long as necessary, but not exceeding six weeks from that decision. In such a case, the hosting service provider shall not disclose any information on the removal or disabling of access to terrorist content. That competent authority may extend that period by a further six weeks, where such non-disclosure continues to be justified. SECTION IV COMPETENT AUTHORITIES AND COOPERATION Article 12 Designation of competent authorities 1. Each Member State shall designate the authority or authorities competent to: (a) issue removal orders pursuant to Article 3; (b) scrutinise removal orders pursuant to Article 4; (c) oversee the implementation of specific measures pursuant to Article 5; (d) impose penalties pursuant to Article 18. 2. Each Member State shall ensure that a contact point is designated or established within the competent authority referred to in point (a) of paragraph 1 to handle requests for clarification and feedback in relation to removal orders issued by that competent authority. Member States shall ensure that the information on the contact point is made publicly available. 3. By 7 June 2022, Member States shall notify the Commission of the competent authority or authorities referred to in paragraph 1 and any modification thereof. The Commission shall publish the notification and any modification thereto in the Official Journal of the European Union. 4. By 7 June 2022, the Commission shall set up an online register listing the competent authorities referred to in paragraph 1 and the contact point designated or established pursuant to paragraph 2 for each competent authority. The Commission shall publish any modification thereto regularly. Article 13 Competent authorities 1. Member States shall ensure that their competent authorities have the necessary powers and sufficient resources to achieve the aims of and fulfil their obligations under this Regulation. 2. Member States shall ensure that their competent authorities carry out their tasks under this Regulation in an objective and non-discriminatory manner while fully respecting fundamental rights. Competent authorities shall not seek or take instructions from any other body in relation to the carrying out of their tasks under Article 12(1). The first subparagraph shall not prevent supervision in accordance with national constitutional law. Article 14 Cooperation between hosting service providers, competent authorities and Europol 1. Competent authorities shall exchange information, coordinate and cooperate with each other and, where appropriate, with Europol, with regard to removal orders, in particular to avoid duplication of effort, enhance coordination and avoid interference with investigations in different Member States. 2. Competent authorities of Member States shall exchange information, coordinate and cooperate with the competent authorities referred to in points (c) and (d) of Article 12(1) with regard to specific measures taken pursuant to Article 5 and penalties imposed pursuant to Article 18. Member States shall ensure that the competent authorities referred to in points (c) and (d) of Article 12(1) are in possession of all the relevant information. 3. For the purposes of paragraph 1, Member States shall provide for the appropriate and secure communication channels or mechanisms to ensure that the relevant information is exchanged in a timely manner. 4. For the effective implementation of this Regulation as well as to avoid duplication of effort, Member States and hosting service providers may make use of dedicated tools, including those established by Europol, to facilitate in particular: (a) the processing and feedback relating to removal orders pursuant to Article 3; and (b) cooperation with a view to identifying and implementing specific measures pursuant to Article 5. 5. Where hosting service providers become aware of terrorist content involving an imminent threat to life, they shall promptly inform authorities competent for the investigation and prosecution of criminal offences in the Member States concerned. Where it is impossible to identify the Member States concerned, the hosting service providers shall notify the contact point pursuant to Article 12(2) in the Member State where they have their main establishment or where their legal representative resides or is established, and transmit information concerning that terrorist content to Europol for appropriate follow-up. 6. The competent authorities are encouraged to send copies of the removal orders to Europol to allow it to provide an annual report that includes an analysis of the types of terrorist content subject to an order to remove it or to disable access thereto pursuant to this Regulation. Article 15 Hosting service providers\u2019 contact points 1. Each hosting service provider shall designate or establish a contact point for the receipt of removal orders by electronic means and their expeditious processing pursuant to Articles 3 and 4. The hosting service provider shall ensure that information about the contact point is made publicly available. 2. The information referred to in paragraph 1 of this Article shall specify the official languages of the Union institutions referred to in Regulation 1/58 (15) in which the contact point can be addressed and in which further exchanges in relation to removal orders pursuant to Article 3 are to take place. Those languages shall include at least one of the official languages of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established. SECTION V IMPLEMENTATION AND ENFORCEMENT Article 16 Jurisdiction 1. The Member State of the main establishment of the hosting service provider shall have jurisdiction for the purposes of Articles 5, 18 and 21. A hosting service provider which does not have its main establishment within the Union shall be deemed to be under the jurisdiction of the Member State where its legal representative resides or is established. 2. Where a hosting service provider which does not have its main establishment in the Union fails to designate a legal representative, all Member States shall have jurisdiction. 3. Where a competent authority of a Member State exercises jurisdiction pursuant to paragraph 2, it shall inform the competent authorities of all other Member States. Article 17 Legal representative 1. A hosting service provider which does not have its main establishment in the Union shall designate, in writing, a natural or legal person as its legal representative in the Union for the purpose of the receipt of, compliance with and the enforcement of removal orders and decisions issued by the competent authorities. 2. The hosting service provider shall provide its legal representative with the necessary powers and resources to comply with those removal orders and decisions and to cooperate with the competent authorities. The legal representative shall reside or be established in one of the Member States where the hosting service provider offers its services. 3. The legal representative may be held liable for infringements of this Regulation, without prejudice to any liability of or legal actions against the hosting service provider. 4. The hosting service provider shall notify the competent authority referred to in point (d) of Article 12(1) of the Member State where its legal representative resides or is established of the designation. The hosting service provider shall make the information about the legal representative publicly available. SECTION VI FINAL PROVISIONS Article 18 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation by hosting service providers and shall take all measures necessary to ensure that they are implemented. Such penalties shall be limited to addressing infringements of Article 3(3) and (6), Article 4(2) and (7), Article 5(1), (2), (3), (5) and (6), Articles 6, 7, 10 and 11, Article 14(5), Article 15(1) and Article 17. The penalties referred to in the first subparagraph shall be effective, proportionate and dissuasive. Member States shall, by 7 June 2022, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them. 2. Member States shall ensure that the competent authorities, when deciding whether to impose a penalty and when determining the type and level of penalty, take into account all relevant circumstances, including: (a) the nature, gravity and duration of the infringement; (b) whether the infringement was intentional or negligent; (c) previous infringements by the hosting service provider; (d) the financial strength of the hosting service provider; (e) the level of cooperation of the hosting service provider with the competent authorities; (f) the nature and size of the hosting service provider, in particular whether it is a micro, small or medium-sized enterprise; (g) the degree of fault of the hosting service provider, taking into account the technical and organisational measures taken by the hosting service provider to comply with this Regulation. 3. Member States shall ensure that a systematic or persistent failure to comply with obligations pursuant to Article 3(3) is subject to financial penalties of up to 4 % of the hosting service provider\u2019s global turnover of the preceding business year. Article 19 Technical requirements and amendments to the annexes 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 in order to supplement this Regulation with the necessary technical requirements for the electronic means to be used by competent authorities for the transmission of removal orders. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 to amend the annexes in order to effectively address a possible need for improvements regarding the content of templates for removal orders and to provide information on the impossibility to execute removal orders. Article 20 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 19 shall be conferred on the Commission for an indeterminate period of time from 7 June 2022. 3. The delegation of power referred to in Article 19 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day after the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 19 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 21 Monitoring 1. Member States shall collect from their competent authorities and the hosting service providers under their jurisdiction and send to the Commission by 31 March of every year information about the actions they have taken in accordance with this Regulation in the previous calendar year. That information shall include: (a) the number of removal orders issued and the number of items of terrorist content which have been removed or access to which has been disabled and the speed of the removal or disabling; (b) the specific measures taken pursuant to Article 5, including the number of items of terrorist content which have been removed or access to which has been disabled and the speed of the removal or disabling; (c) the number of access requests issued by competent authorities regarding content preserved by hosting service providers pursuant to Article 6; (d) the number of complaint procedures initiated and actions taken by the hosting service providers pursuant to Article 10; (e) the number of administrative or judicial review proceedings initiated and decisions taken by the competent authority in accordance with national law. 2. By 7 June 2023, the Commission shall establish a detailed programme for monitoring the outputs, results and impacts of this Regulation. The monitoring programme shall set out the indicators and the means by which and the intervals at which the data and other necessary evidence are to be collected. It shall specify the actions to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence to monitor the progress and evaluate this Regulation pursuant to Article 23. Article 22 Implementation report By 7 June 2023, the Commission shall submit a report on the application of this Regulation to the European Parliament and to the Council. That report shall include information on monitoring under Article 21 and information resulting from the transparency obligations under Article 8. Member States shall provide the Commission with the information necessary for the drafting of the report. Article 23 Evaluation By 7 June 2024, the Commission shall carry out an evaluation of this Regulation and submit a report to the European Parliament and to the Council on its application including: (a) the functioning and effectiveness of the safeguard mechanisms, in particular those provided for in Article 4(4), Article 6(3) and Articles 7 to 11; (b) the impact of the application of this Regulation on fundamental rights, in particular the freedom of expression and information, the respect for private life and the protection of personal data; and (c) the contribution of this Regulation to the protection of public security. Where appropriate, the report shall be accompanied by legislative proposals. Member States shall provide the Commission with the information necessary for the drafting of the report. The Commission shall also assess the necessity and feasibility of establishing a European platform on terrorist content online for facilitating communication and cooperation under this Regulation. Article 24 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 7 June 2022. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 April 2021. For the European Parliament The President D.M. SASSOLI For the Council The President A.P. ZACARIAS (1) OJ C 110, 22.3.2019, p. 67. (2) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and position of the Council at first reading of 16 March 2021 (OJ C 135, 16.4.2021, p. 1). Position of the European Parliament of 28 April 2021 (not yet published in the Official Journal). (3) Commission Recommendation (EU) 2018/334 of 1 March 2018 on measures to effectively tackle illegal content online (OJ L 63, 6.3.2018, p. 50). (4) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (\u2018Directive on electronic commerce\u2019) (OJ L 178, 17.7.2000, p. 1). (5) Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, p. 1). (6) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, p. 6). (7) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36). (8) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (9) Regulation (EU) 2018/302 of the European Parliament and of the Council of 28 February 2018 on addressing unjustified geo-blocking and other forms of discrimination based on customers\u2019 nationality, place of residence or place of establishment within the internal market and amending Regulations (EC) No 2006/2004 and (EU) 2017/2394 and Directive 2009/22/EC (OJ L 60 I, 2.3.2018, p. 1). (10) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73). (11) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53). (12) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (13) OJ L 123, 12.5.2016, p. 1. (14) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (15) Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). ANNEX I REMOVAL ORDER (Article 3 of Regulation (EU) 2021/784 of the European Parliament and of the Council) Pursuant to Article 3 of Regulation (EU) 2021/784 (the \u2018Regulation\u2019) the addressee of this removal order shall remove terrorist content or disable access to terrorist content in all Member States as soon as possible and in any event within one hour of receipt of the removal order. Pursuant to Article 6 of the Regulation the addressee shall preserve content and related data, which has been removed or access to which as been disabled, for six months or longer upon request from the competent authorities or courts. Pursuant to Article 15(2) of the Regulation, this removal order shall be sent in one of the languages designated by the addressee. SECTION A: Member State of the issuing competent authority: \u2026\u2026 NB: details of the issuing competent authority to be provided in Sections E and F Addressee and, where relevant, legal representative: \u2026\u2026 Contact point: \u2026\u2026 Member State where the hosting service provider has its main establishment or where its legal representative resides or is established: \u2026\u2026 Time and date of issuing of the removal order: \u2026\u2026 Reference number of the removal order: \u2026\u2026 SECTION B: Terrorist content to be removed or access to which is to be disabled in all Member States as soon as possible and in any event within one hour of receipt of the removal order URL and any additional information enabling the identification and exact location of the terrorist content: \u2026\u2026 Reasons for considering the material to be terrorist content, in accordance with point (7) of Article 2 of the Regulation. The material (please tick the relevant box(es)): incites others to commit terrorist offences, such as by glorifying terrorist acts, by advocating the commission of such offences (point (7)(a) of Article 2 of the Regulation) solicits others to commit or to contribute to the commission of terrorist offences (point (7)(b) of Article 2 of the Regulation) solicits others to participate in the activities of a terrorist group (point (7)(c) of Article 2 of the Regulation) provides instruction on the making or use of explosives, firearms or other weapons or noxious or hazardous substances, or on other specific methods or techniques for the purpose of committing or contributing to the commission of terrorist offences (point (7)(d) of Article 2 of the Regulation) constitutes a threat to commit one of the terrorist offences (point (7)(e) of Article 2 of the Regulation) Additional information for considering the material to be terrorist content: \u2026\u2026 \u2026\u2026 \u2026\u2026 SECTION C: Information to the content provider Please note that (please tick the box, if applicable): for reasons of public security, the addressee must refrain from informing the content provider of the removal of or disabling of access to the terrorist content If the box is not applicable, please see Section G for details of possibilities to challenge the removal order in the Member State of the issuing competent authority under national law (a copy of the removal order must be sent to the content provider, if requested) SECTION D: Information to the competent authority of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established Please tick the relevant box(es): The Member State where the hosting service provider has its main establishment or where its legal representative resides or is established is other than the Member State of the issuing competent authority A copy of the removal order is sent to the competent authority of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established SECTION E: Details of the issuing competent authority Type (please tick the relevant box): judge, court or investigating judge law enforcement authority other competent authority please complete also Section F Details of the issuing competent authority or its representative certifying the removal order as accurate and correct: Name of the issuing competent authority: \u2026\u2026 Name of its representative and post held (title and grade): \u2026\u2026 File No: \u2026\u2026 Address: \u2026\u2026 Tel. No (country code) (area/city code): \u2026\u2026 Fax No (country code) (area/city code): \u2026\u2026 Email address:\u2026 Date:\u2026 Official stamp (if available) and signature (1): \u2026\u2026 SECTION F: Contact details for follow-up Contact details of the issuing competent authority for feedback on the time of removal or the disabling of access, or to provide further clarification: \u2026\u2026 Contact details of the competent authority of the Member State where the hosting service provider has its main establishment or where its legal representative resides or is established: \u2026\u2026 SECTION G: Information about redress possibilities Information about competent body or court, deadlines and procedures for challenging the removal order: Competent body or court before which the removal order can be challenged: \u2026\u2026 Deadline for challenging the removal order (days/months starting from): \u2026\u2026 Link to provisions in national legislation: \u2026\u2026 (1) A signature is not necessary if the removal order is sent through authenticated submission channels that can guarantee the authenticity of the removal order. ANNEX II FEEDBACK FOLLOWING REMOVAL OF OR DISABLING OF ACCESS TO TERRORIST CONTENT (Article 3(6) of Regulation (EU) 2021/784 of the European Parliament and of the Council) SECTION A: Addressee of the removal order: \u2026\u2026 Competent authority that issued the removal order: \u2026\u2026 File reference of the competent authority that issued the removal order: \u2026\u2026 File reference of the addressee: \u2026\u2026 Time and date of receipt of removal order: \u2026\u2026 SECTION B: Measures taken in compliance with the removal order (Please tick the relevant box): the terrorist content has been removed access to the terrorist content has been disabled in all Member States Time and date of the measure taken: \u2026\u2026 SECTION C: Details of the addressee Name of the hosting service provider: \u2026\u2026 OR Name of the legal representative of the hosting service provider: \u2026\u2026 Member State of main establishment of the hosting service provider: \u2026\u2026 OR Member State of residence or establishment of the legal representative of the hosting service provider: \u2026\u2026 Name of the authorised person: \u2026\u2026 Email address of the contact point: \u2026\u2026 Date: \u2026\u2026 ANNEX III INFORMATION ABOUT THE IMPOSSIBILITY TO EXECUTE THE REMOVAL ORDER (Article 3(7) and (8) of Regulation (EU) 2021/784 of the European Parliament and of the Council) SECTION A: Addressee of the removal order: \u2026\u2026 Competent authority that issued the removal order: \u2026\u2026 File reference of the competent authority that issued the removal order: \u2026\u2026 File reference of the addressee: \u2026\u2026 Time and date of receipt of removal order: \u2026\u2026 SECTION B: Non-execution (1) The removal order cannot be executed within the deadline for the following reasons (please tick the relevant box(es)): force majeure or de facto impossibility not attributable to the hosting service provider, including for objectively justifiable technical or operational reasons the removal order contains manifest errors the removal order does not contain sufficient information (2) Please provide further information as to the reasons for non-execution: \u2026\u2026 (3) If the removal order contains manifest errors and/or does not contain sufficient information, please specify the errors and the further information or clarification necessary: \u2026\u2026 SECTION C: Details of the hosting service provider or its legal representative Name of the hosting service provider: \u2026\u2026 OR Name of the legal representative of the hosting service provider: \u2026\u2026 Name of the authorised person: \u2026\u2026 Contact details (email address): \u2026\u2026 Signature: \u2026\u2026 Time and date: \u2026\u2026", "summary": "Fight against terrorism \u2014 dissemination of content online Fight against terrorism \u2014 dissemination of content online SUMMARY OF: Regulation (EU) 2021/784 on addressing the dissemination of terrorist content online WHAT IS THE AIM OF THE REGULATION? It aims to enable the swift removal of terrorist content* online and sets out European Union (EU)-wide rules to this effect. KEY POINTS Scope The regulation sets out EU-wide rules to tackle the misuse of hosting services for the public dissemination of terrorist content online. These rules cover: the reasonable and proportionate duties of care to be applied by hosting service providers* (HSPs) to tackle the public dissemination of terrorist content through their services and ensure, where necessary, that such content is removed or access to it is disabled; the measures to be put in place by EU Member States, in accordance with EU law and subject to fundamental rights safeguards, in order to: identify and ensure the prompt removal of terrorist content by HSPs; andfacilitate cooperation among the competent Member States\u2019 authorities, HSPs and, where appropriate, Europol. The regulation applies to HSPs offering services in the EU, whether or not they are mainly based within the Member States. Material disseminated to the public for educational, journalistic, artistic or research purposes, or for the purposes of preventing or countering terrorism, will not be considered to be terrorist content. Terrorist offences are defined in Directive (EU) 2017/541 \u2014 see summary. Measures The regulation sets out a number of measures to address the public dissemination of terrorist content online including: removal orders \u2014 HSPs issued with an order would have to remove or block such content within 1 hour; procedures for cross-border removals \u2014 i.e. where the HSP is not based in the same Member State as the national authority issuing the removal order; specific measures to be taken by HSPs exposed to such content; preservation of such content by HSPs for administrative or judicial purposes. Safeguards and accountability The regulation includes a number of measures to ensure transparency and legal rights. These include rules covering: transparency obligations for HSPs; transparency reports by national authorities; legal remedies for HSPs and content providers*; complaints mechanisms; information to content providers. FROM WHEN DOES THE REGULATION APPLY? It applies from 7 June 2022. BACKGROUND Terrorist content online (European Commission). KEY TERMS Terrorist content: material that incites or solicits an individual or a group of people to commit a terrorist act, or that provides instruction on making weapons or on other methods or techniques for use in a terrorist attack. Hosting service provider: storers of information provided by and at the request of a content provider. Content provider: a user that has provided information that is, or that has been, stored and disseminated to the public by a hosting service provider. MAIN DOCUMENT Regulation (EU) 2021/784 of the European Parliament and of the Council of 29 April 2021 on addressing the dissemination of terrorist content online (OJ L 172, 17.5.2021, pp. 79-109) RELATED DOCUMENTS Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 A Counter-Terrorism Agenda for the EU: Anticipate, Prevent, Protect, Respond (COM(2020) 795 final, 9.12.2020) Communication from the Commission to the European Parliament, the European Council, the Council, the Eurpoean Economic and Social Committee and the Committee of the Regions on the EU Security Union Strategy (COM(2020) 605 final, 24.7.2020) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (Recast) (OJ L 321, 17.12.2018, pp. 36-214) Successive amendments to Directive (EU) 2018/1972 have been incorporated into the original text. This consolidated version is of documentary value only. Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, pp. 6-21) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, pp. 1-15) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, pp. 73-114) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (recast) (OJ L 351, 20.12.2012, pp. 1-32) See consolidated version. Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, pp. 1-24) See consolidated version. Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (\u2018Directive on electronic commerce\u2019) (OJ L 178, 17.7.2000, pp. 1-16) last update 30.08.2021"}
{"article": "12.5.2021 EN Official Journal of the European Union L 170/1 REGULATION (EU) 2021/695 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 173(3), Article 182(1), Article 183, and the second paragraph of Article 188 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinions of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) It is an objective of the Union to strengthen its scientific and technological bases by strengthening the European research area (ERA) in which researchers, scientific knowledge and technology circulate freely and encouraging it to become more competitive, including in its industry, while promoting all research and innovation (R&I) activities to deliver on the Union's strategic priorities and commitments, which ultimately aim to promote peace, the Union's values and the well-being of its peoples. (2) To deliver scientific, technological, economic, environmental and societal impact in pursuit of this general objective and to maximise the added value of the Union's R&I investments, the Union should invest in R&I through Horizon Europe - the Framework Programme for Research and Innovation 2021-2027 (the 'Programme'). The Programme should support the creation, better diffusion and transfer of high-quality and excellent knowledge and high-quality technologies in the Union, attract talent at all levels and contribute to full engagement of the Union's talent pool, facilitate collaborative links and strengthen the impact of R&I in developing, supporting and implementing Union policies, support and strengthen the uptake and deployment of innovative and sustainable solutions in the Union's economy, in particular in small and medium-sized enterprises (SMEs), and in society, address global challenges, including climate change and the United Nations Sustainable Development Goals (SDGs), create jobs, boost economic growth, promote industrial competitiveness and boost the attractiveness of the Union in the field of R&I. The Programme should foster all forms of innovation, including breakthrough innovation, foster market deployment of innovative solutions, and optimise the delivery of such investment for increased impact within a strengthened ERA. (3) The Programme should be established for the duration of the multiannual financial framework (MFF) 2021-2027 as laid down in Council Regulation (EU, Euratom) 2020/2093 (4), without prejudice to the time limits set out in Council Regulation (EU) 2020/2094 (5). (4) The Programme should contribute to increasing public and private investment in R&I in Member States, thereby helping to reach an overall investment target of at least 3 % of the Union's gross domestic product (GDP) in research and development. Achieving that target would require Member States and the private sector to complement the Programme with their own reinforced investment actions in research, development and innovation. (5) With a view to achieving the objectives of the Programme and while respecting the principle of excellence, the Programme should aim to strengthen, among other things, collaborative links in Europe thereby contributing to reducing the R&I divide. (6) To help achieve Union policy objectives, activities supported under this Programme should, where relevant, take advantage of and inspire innovation-friendly regulation, in line with the innovation principle, to support a faster and more intensive transformation of the Union's substantial knowledge assets into innovation. (7) The concepts of 'open science', 'open innovation' and 'open to the world' should ensure excellence and the impact of the Union's investment in R&I, while safeguarding the Union's interests. (8) Open science, including open access to scientific publications and research data, as well as optimal dissemination and exploitation of knowledge have the potential to increase the quality, impact and benefits of science. They also have the potential to accelerate the advancement of knowledge by making it more reliable, efficient and accurate, more easily understood by society and responsive to societal challenges. Provisions should be laid down to ensure that beneficiaries provide open access to peer-reviewed scientific publications. Likewise, it should be ensured that beneficiaries provide open access to research data following the principle 'as open as possible, as closed as necessary', while ensuring the possibility of exceptions taking into account the legitimate interests of the beneficiaries. More emphasis should in particular be given to the responsible management of research data, which should comply with the principles of 'findability', 'accessibility', 'interoperability' and 'reusability' (the 'FAIR principles'), in particular through the mainstreaming of data management plans. Where appropriate, beneficiaries should make use of the possibilities offered by the European Open Science Cloud (EOSC) and the European Data Infrastructure and adhere to further open science principles and practices. Reciprocity in open science should be encouraged in all association and cooperation agreements with third countries. (9) Beneficiaries of the Programme, especially SMEs, are to be encouraged to make use of the relevant existing Union's instruments, such as the European IP Helpdesk that supports SMEs and other participants in the Programme in both protecting and enforcing their intellectual property (IP) rights. (10) The conception and design of the Programme should respond to the need for establishing a critical mass of supported activities throughout the Union, encouraging excellence-based participation of all Member States, and through international cooperation, in line with the 2030 Agenda for Sustainable Development (the '2030 Agenda'), the SDGs and the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (6) (the 'Paris Agreement'). Programme implementation should reinforce the pursuit of the SDGs and the commitment of the Union and its Member States to implementing the 2030 Agenda to achieving its three dimensions \u2013 economic, social and environmental \u2013 in a coherent and integrated manner. (11) Activities supported under the Programme should contribute towards the achievement of the Union's objectives, priorities and international commitments. (12) The Programme should benefit from complementarity with existing relevant European R&I roadmaps and strategies, as well as with important projects of common European interest (IPCEIs), where relevant, provided that related R&I needs are identified in the Programme's strategic planning. (13) The Programme should ensure transparency and accountability of public funding in R&I projects, thereby preserving the public interest. (14) The Programme should support R&I activities in the field of social sciences and humanities (SSH). This entails advancing scientific knowledge in that domain and making use of insights and progress from SSH to increase the economic and societal impact of the Programme. Under the pillar 'Global Challenges and European Industrial Competitiveness', SSH should be fully integrated across all clusters. Beyond the promotion of SSH in projects, the integration of SSH should also be supported through the inclusion, whenever appropriate, of independent external experts from the field of SSH in expert committees and evaluation panels, and through timely monitoring and reporting of SSH in funded research actions. In particular, the level of mainstreaming of SSH should be monitored across the Programme. (15) The Programme should maintain a balanced approach between research on the one hand and innovation on the other, as well as between bottom-up funding (investigator or innovator driven) and top-down funding (determined by strategically defined priorities), by reference to the nature of the R&I communities that are engaged across the Union, the types and purpose of the activities carried out and the impacts that are sought. The mix of those factors should determine the choice of approach for the relevant parts of the Programme, all of which contribute to all general and specific objectives of the Programme. (16) The overall budget for the 'widening participation and spreading excellence' component of the 'Widening Participation and Strengthening the ERA' part of the Programme should be at least 3,3 % of the overall Programme budget and should mainly benefit legal entities established in the widening countries. (17) Excellence initiatives should aim to strengthen R&I excellence in the eligible countries, including supporting training to improve R&I managerial skills, prizes, strengthening innovation ecosystems as well as the creation of R&I networks, including on the basis of research infrastructures financed by the Union. Applicants should clearly show that projects are linked with national and/or regional R&I strategies to be eligible to apply for funding under the 'widening participation and spreading excellence' component of the 'Widening Participation and Strengthening the ERA' part of the Programme. (18) It should be possible to apply a fast track to R&I procedure, where time-to-grant should not exceed six months, to allow for faster, bottom-up access to funds for small collaborative consortia covering actions from fundamental research to market application. (19) The Programme should support all stages of R&I especially within collaborative projects and in missions and European Partnerships, as appropriate. Fundamental research is an essential asset of and an important condition for increasing the Union's ability to attract the best scientists in order to become a global hub of excellence. A balance between basic and applied research should be ensured in the Programme. Coupled with innovation, that balance will support the Union's economic competitiveness, growth and jobs. (20) Evidence shows that embracing diversity, in all senses, is key to doing good science, as science benefits from diversity. Diversity and inclusiveness contribute to excellence in collaborative R&I: collaboration across disciplines, sectors and throughout the ERA makes for better research and higher quality project proposals, can lead to higher rates of societal take-up and can foster the benefits of innovation, thus advancing Europe. (21) In order to maximise the impact of the Programme, particular consideration should be given to multidisciplinary, interdisciplinary and transdisciplinary approaches as key elements for major scientific progress. (22) Research activities carried out under the pillar 'Excellent Science' should be determined according to the needs and opportunities of science and should promote scientific excellence. The research agenda should be set in close liaison with the scientific community and include emphasis on attracting new R&I talents, early stage researchers, while strengthening the ERA, avoiding brain drain and promoting brain circulation. (23) The Programme should support the Union and its Member States in attracting the best talents and skills, taking into account the reality of very intense international competition. (24) The pillar 'Global Challenges and European Industrial Competitiveness' should be established through clusters of R&I activities, in order to maximise integration across the respective thematic areas while securing high and sustainable levels of impact for the Union in relation to the resources that are expended. It would encourage cross-disciplinary, cross-sectoral, cross-policy and cross-border collaboration in pursuit of the SDGs by following the principles of the 2030 Agenda, the Paris Agreement and the competitiveness of the Union's industries. The organisation of high-ambition, wide-scale initiatives in the form of R&I missions would enable the Programme to achieve a transformative and systemic impact for society in support of the SDGs, also through international cooperation and science diplomacy. The activities under that pillar should cover the full range of R&I activities to ensure that the Union remains at the cutting-edge in strategically defined priorities. (25) The cluster 'Culture, Creativity and Inclusive Society' should contribute substantially to the research on cultural and creative sectors, including on the Union's cultural heritage and in particular allowing the establishment of a European cultural heritage collaborative space. (26) Full and timely engagement of all types of industry in the Programme, from individual entrepreneurs and SMEs to large scale enterprises, would substantially contribute to the realisation of the objectives of the Programme and specifically towards the creation of sustainable jobs and growth in the Union. Such engagement by the industry should see its participation in the actions supported at levels at least commensurate with those under the framework programme Horizon 2020 established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council (7) (Horizon 2020). (27) Actions under the Programme would substantially contribute towards unlocking the potential of the Union's strategic sectors, including key enabling technologies that reflect the Union's industrial policy strategy objectives. (28) Multi-stakeholder consultations, including of civil society and industry, should contribute to the perspectives and priorities established through the strategic planning. This should result in periodic strategic R&I plans adopted by means of implementing acts for preparing the content of work programmes. (29) For a particular action to be funded, the work programme should take into account the outcome of specific previous projects as well as the state of science, technology and innovation at national, Union and international level and of the relevant policy, market and societal developments. (30) It is important to support the Union's industry in remaining or in becoming a world leader in innovation, digitisation and climate neutrality, in particular through investments in key enabling technologies that will underpin tomorrow's business. The Programme's actions should address market failures or sub-optimal investment situations, boost investments in a proportionate and transparent manner, without duplicating or crowding out private financing and have a clear European added value and public return on investments. This will ensure consistency between the actions of the Programme and Union State aid rules, in order to incentivise innovation and avoid undue distortions of competition in the internal market. (31) The Programme should support R&I in an integrated manner, respecting all relevant provisions in the framework of the World Trade Organization. The concept of research, including experimental development, should be used in accordance with the Frascati Manual developed by the Organisation for Economic Co-operation and Development (OECD), whereas the concept of innovation should be used in accordance with the Oslo Manual developed by the OECD and Eurostat, which follows a broad approach that covers social innovation and design. As in Horizon 2020, the OECD definitions regarding technological readiness levels (TRLs) should continue to be taken into account in the classification of technological research, product development and demonstration activities, and in the definition of types of action available in calls for proposals. Grants should not be awarded for actions where activities go above TRL 8. It should be possible for the work programme to allow grants for large-scale product validation and market replication for a given call under the pillar 'Global Challenges and European Industrial Competitiveness'. (32) The Programme should contribute to space objectives at a level of spending that is at least proportionally commensurate with that under Horizon 2020. (33) The Commission communication of 11 January 2018 entitled 'Horizon 2020 interim evaluation: maximising the impact of EU research and innovation', the resolution of the European Parliament of 13 June 2017 on the assessment of Horizon 2020 implementation in view of its interim evaluation and the Framework Programme 9 proposal (8) and the Council Conclusions of 1 December 2017 entitled 'From the Interim Evaluation of Horizon 2020 towards the ninth Framework Programme' have provided a set of recommendations for the Programme, including for its rules for participation and dissemination. Those recommendations build on the lessons learnt from Horizon 2020 as well as input from Union institutions and stakeholders. Those recommendations include the proposal of measures to promote brain circulation and facilitate openness of R&I networks to invest more ambitiously in order to reach critical mass and maximise impact; to support breakthrough innovation; to prioritise Union R&I investments in areas of high added value, in particular through mission-orientation, full, well-informed and timely citizen involvement and wide communication; to rationalise the Union funding landscape in order to fully use the R&I potential, including research infrastructures across the Union, such as by streamlining the range of European Partnership initiatives and co-funding schemes; to develop more and concrete synergies between different Union funding instruments, in particular by overcoming non-complementary intervention logics and complexity of the various funding and other regulations also with the aim of helping to mobilise under-exploited R&I potential across the Union; to strengthen international cooperation and reinforce openness to third countries' participation; and to continue simplification based on implementation experiences of Horizon 2020. (34) Given that special attention needs to be paid to coordination and complementarity between different Union policies, the Programme should seek synergies with other Union programmes, from their design and strategic planning, to project selection, management, communication, dissemination and exploitation of results, monitoring, auditing and governance. Regarding funding for R&I activities, synergies should allow for the harmonisation of rules, including cost eligibility rules, as much as possible. With a view to avoiding duplication or overlaps, to increasing the leverage of Union funding and to decreasing the administrative burden for applicants and beneficiaries, it should be possible to promote synergies, in particular by alternative, combined, cumulative funding and transfers of resources. (35) In accordance with Regulation (EU) 2020/2094 and within the limits of the resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented consequences of the COVID-19 crisis. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation (EU) 2020/2094. Such additional resources should be allocated exclusively to actions for R&I directed at addressing the consequences of the COVID-19 crisis and in particular its economic, social and societal consequences. (36) In order for Union funding to have the greatest possible impact and to make the most effective contribution to the Union's policy objectives and commitments, it should be possible for the Union to enter into European Partnerships with private and/or public sector partners. Such partners include industry, SMEs, universities, research organisations, R&I stakeholders, bodies with a public service mission at local, regional, national or international level or civil society organisations, including foundations and non-governmental organisations (NGOs) that support and/or carry out R&I, provided that the desired impacts can be achieved more effectively in partnership than by the Union alone. (37) It should be possible, depending on the Member State's decision, that the contributions from programmes co-financed by the European Regional Development Fund (ERDF), the European Social Fund Plus (ESF+), the European Maritime, Fisheries and Aquaculture Fund (EMFAF) and the European Agricultural Fund for Rural Development (EAFRD) be considered to be a contribution of the participating Member State to European Partnerships under the Programme. However, that possibility should be without prejudice to the need to comply with all provisions applicable to those contributions as set out in a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the 'Common Provisions Regulation for 2021-2027') and the fund-specific regulations. (38) The Programme should strengthen cooperation between European Partnerships and private and/or public sector partners at international level, including by joining up R&I programmes and cross-border investment in R&I bringing mutual benefits to people and businesses while ensuring that the Union can uphold its interests in strategic areas. (39) Future Emerging Technologies (FET) Flagships have proven to be an effective and efficient instrument, delivering benefits for society in a joint, coordinated effort by the Union and its Member States. Activities carried out within the FET Flagships on Graphene, the Human Brain Project and Quantum Technology, which are supported under Horizon 2020, will continue to be supported under the Programme through calls for proposals included in the work programme. Preparatory actions supported under the FET Flagships part of Horizon 2020 will feed the strategic planning under the Programme and inform the work on missions, co-funded and/or co-programmed European Partnerships and regular calls for proposals. (40) The Joint Research Centre (JRC) should continue to provide independent customer-driven scientific evidence and technical support for Union policies throughout the whole policy cycle. The direct actions of the JRC should be implemented in a flexible, efficient and transparent manner, taking into account the needs of Union policies and the relevant needs of the users of the JRC and ensuring the protection of the Union's financial interests. The JRC should continue to generate additional resources. (41) The pillar 'Innovative Europe' should establish a series of measures for the provision of integrated support to respond to the needs of entrepreneurs and entrepreneurship aiming to realise and accelerate breakthrough innovation for rapid market growth as well as to promote the Union's strategic autonomy while preserving an open economy. It should provide a one-stop shop to attract and support all types of innovators and innovative companies, such as SMEs, including start-ups, and, in exceptional cases, small mid-caps, with potential for scaling up at Union and international level. The pillar should offer fast, flexible grants and co-investments, including with private investors. Those objectives should be pursued through the creation of a European Innovation Council (EIC). The pillar should also support the European Institute of Innovation and Technology (EIT) and European innovation ecosystems at large, in particular through European Partnerships with national and regional innovation support actors. (42) For the purpose of this Regulation and in particular for the activities carried out under the EIC, a 'start-up' should be understood as an SME in the early stage of its life cycle, including those that are created as spin-offs from university research activities, which aims to find innovative solutions and scalable business models, and which is autonomous within the meaning of Article 3 of the Annex to Commission Recommendation 2003/361/EC (9); a 'mid-cap' should be understood as an enterprise that is not an SME and that has between 250 and 3 000 employees, where the staff headcount is calculated in accordance with Articles 3 to 6 of Title I of the Annex to that Recommendation; and a 'small mid-cap' should be understood as a mid-cap that has up to 499 employees. (43) The policy objectives of the Programme are to be addressed also through financial instruments and budgetary guarantee of the InvestEU Programme, thereby promoting synergies between the two programmes. (44) The EIC, together with other components of the Programme, should stimulate all forms of innovation, ranging from incremental to breakthrough and disruptive innovation, targeting especially market-creating innovation. Through its Pathfinder and Accelerator instruments, the EIC should aim to identify, develop and deploy high-risk innovations of all kinds, including incremental innovations, with a main focus on breakthrough, disruptive and deep-tech innovations that have the potential to become market-creating innovations. Through coherent and streamlined support, the EIC should fill the current vacuum in public support and private investment for breakthrough innovation. The instruments of the EIC require dedicated legal and management features in order to reflect its objectives, in particular market deployment action. (45) The Accelerator is intended to bridge the 'valley of death' between research, pre-mass commercialisation and the scaling-up of companies. The Accelerator will provide support to high-potential operations presenting such technological, scientific, financial, management or market risks that they are not yet considered to be bankable and therefore cannot raise significant investments from the market, hence complementing the InvestEU Programme. (46) In close synergy with the InvestEU Programme, the Accelerator, in its blended finance and equity financial support forms, should finance projects run by SMEs, including start-ups, and, in exceptional cases, small mid-caps, which are either not yet able to generate revenues, or not yet profitable, or not yet able to attract sufficient investment to implement fully their projects' business plan. Such eligible entities would be considered to be non-bankable, while a part of their investment needs could have been or could be provided by one or several investors, such as a private or public bank, a family office, a venture capital fund or a business angel. In that way the Accelerator is intended to overcome a market failure and finance promising, but not yet bankable entities engaged in breakthrough market-creating innovation projects. Once they become bankable, those projects could be financed under the InvestEU Programme. (47) While the Accelerator budget should be mainly distributed through blended finance, for the purpose of Article 48, its grant-only support to SMEs, including start-ups, should correspond to that under the SME instrument budget of Horizon 2020. (48) The EIT, primarily through its Knowledge and Innovation Communities (KICs) and by expanding its Regional Innovation Scheme, should aim to strengthen innovation ecosystems that tackle global challenges. This should be achieved by fostering the integration of innovation, research, higher education and entrepreneurship. In accordance with a Regulation of the European Parliament and of the Council on the European Institute of Innovation and Technology (the 'EIT Regulation') and its Strategic Innovation Agenda as referred to in a Decision of the European Parliament and of the Council on the Strategic Innovation Agenda of the European Institute of Innovation and Technology (EIT) 2021-2027 the EIT should foster innovation through its activities and should significantly step up its support to the integration of higher education within the innovation ecosystem, in particular by stimulating entrepreneurial education, fostering strong non-disciplinary collaboration between industry and academia, and identifying prospective skills for future innovators to address global challenges, which include advanced digital and innovation skills. Support schemes provided by the EIT should benefit EIC beneficiaries, while start-ups emerging from the EIT's KICs should have simplified and thereby faster access to EIC actions. While the EIT's focus on innovation ecosystems should make it naturally fit within the pillar 'Innovative Europe', it should also support the other pillars, as appropriate. Unnecessary duplication between KICs and other instruments in the same field, in particular other European Partnerships, should be avoided. (49) A level playing field for competing companies in a given market should be ensured and preserved, since it is a key requirement for all types of innovation, including breakthrough, disruptive and incremental innovation, to flourish thereby enabling in particular a large number of small and medium-size innovators to build-up their R&I capacity, to reap the benefits of their investment and to capture a share of the market. (50) The Programme should promote and integrate cooperation with third countries and international organisations and initiatives based on the Union's interests, mutual benefits, international commitments, science diplomacy and, as far as possible, reciprocity. International cooperation should aim to strengthen the Union's excellence in R&I, attractiveness, capacity to retain best talents and economic and industrial competitiveness, to tackle global challenges including the SDGs by following the principles of the 2030 Agenda and the Paris Agreement, and to support the Union's external policies. An approach of general openness to international participation and targeted international cooperation actions should be followed, including through appropriate eligibility for funding of entities established in low to middle-income countries. The Union should aim to conclude international cooperation agreements in the field of R&I with third countries. At the same time, association of third countries, in particular for collaborative parts to the Programme, should be promoted, in accordance with association agreements and focusing on added value for the Union. When allocating associated countries' financial contributions to the Programme, the Commission should take into account the level of participation of legal entities of those third countries in the different parts of the Programme. (51) With the aim of deepening the relationship between science and society and maximising the benefits of their interactions, the Programme should engage and involve all societal actors, such as citizens and civil society organisations, in co-designing and co-creating responsible research and innovation (RRI) agendas, content and throughout processes that address citizens' and civil society's concerns, needs and expectations, promoting science education, making scientific knowledge publicly accessible, and facilitating participation by citizens and civil society organisations in its activities. This should be done across the Programme and through dedicated activities in the part 'Widening Participation and Strengthening the ERA'. The engagement of citizens and civil society in R&I should be coupled with public outreach activities to generate and sustain public support for the Programme. The Programme should also seek to remove barriers and boost synergies between science, technology, culture and the arts to obtain a new quality of sustainable innovation. The measures taken to improve the involvement of citizens and civil society in the supported projects should be monitored. (52) Where appropriate, the Programme should take into account the specific characteristics of the outermost regions as identified in Article 349 of the Treaty on the Functioning of the European Union (TFEU) and in line with the Commission's communication of 24 October 2017 entitled 'A stronger and renewed strategic partnership with the EU's outermost regions', as welcomed by the Council. (53) The activities developed under the Programme should aim to eliminate gender bias and inequalities, enhancing work-life balance and promoting equality between women and men in R&I, including the principle of equal pay without discrimination based on sex, in accordance with Articles 2 and 3 of the Treaty on European Union (TEU) and Articles 8 and 157 TFEU. The gender dimension should be integrated in R&I content and followed through at all stages of the research cycle. In addition, the activities under the Programme should aim to eliminate inequalities and promote equality and diversity in all aspects of R&I with regard to age, disability, race and ethnicity, religion or belief, and sexual orientation. (54) In light of the specificities of the defence industry sector, the detailed provisions for Union funding to defence research projects should be fixed in Regulation (EU) 2021/697 of the European Parliament and of the Council (10) (the 'European Defence Fund') which defines the rules of participation for defence research. Activities to be carried out under the European Defence Fund should have an exclusive focus on defence research and development, while activities carried out under the specific programme established by Council Decision (EU) 2021/764 (11) (the 'specific programme') and the EIT should have an exclusive focus on civil applications. Unnecessary duplication should be avoided. (55) This Regulation lays down a financial envelope for the entire duration of the Programme which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (12), for the European Parliament and the Council during the annual budgetary procedure. That financial envelope comprises an amount of EUR 580 000 000 in current prices for the specific programme established by Decision (EU) 2021/764 and for the EIT, in line with the joint declaration by the European Parliament, Council and Commission of 16 December 2020 on the reinforcement of specific programmes and adaptation of basic acts (13). (56) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (14) (the 'Financial Regulation') applies to this Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (57) In accordance with Article 193(2) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to Union's interests, it should be possible to provide in the financing decision, during a limited period of time at the beginning of the MFF 2021-2027, and only in duly justified cases, for eligibility of activities and costs from the beginning of the 2021 financial year, even if they were implemented and incurred before the grant application was submitted. (58) Continually throughout the Programme, administrative simplification should be sought, in particular the reduction of the administrative burden for beneficiaries. The Commission should further simplify its tools and guidance in such a way that they impose a minimal burden on beneficiaries. In particular, the Commission should consider issuing an abridged version of the guidance. (59) The completion of the Digital Single Market and the growing opportunities from the convergence of digital and physical technologies require investments to be increased. The Programme should contribute to those efforts with a substantial increase in spending on main digital R&I activities compared to Horizon 2020 (15). This should ensure that Europe remains at the forefront of global R&I in the digital field. (60) Quantum research under the 'Digital, Industry and Space' cluster under Pillar II should be prioritised, given its crucial role in the digital transition, namely by expanding the European scientific leadership and excellence in quantum technologies, enabling the envisaged budget set in 2018 to be achieved. (61) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (16) and Council Regulations (EC, Euratom) No 2988/95 (17), (Euratom, EC) No 2185/96 (18) and (EU) 2017/1939 (19), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor's Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (20). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (62) Third countries which are members of the European Economic Area (EEA) may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (21), which provides for the implementation of the programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. (63) Pursuant to Article 94 of Council Decision 2013/755/EU (22), persons and entities established in overseas countries or territories are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (64) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 for Better Law-Making (23), this Programme should be evaluated on the basis of information collected in accordance with specific reporting and monitoring requirements, while avoiding overregulation and an administrative burden, in particular on the Member States and the beneficiaries of the Programme. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Programme on the ground. (65) In order to ensure the effective assessment of the Programme's progress towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex V with regard to the impact pathway indicators, where considered to be necessary, and to set baselines and targets as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (66) Coherence and synergies between the Programme and the Union Space Programme will foster a globally competitive and innovative European space sector, reinforce Europe's autonomy in accessing and using space in a secure and safe environment and strengthen Europe's role as a global actor. Excellence in research, breakthrough solutions and downstream users in the Programme will be supported by data and services made available by the Union Space Programme. (67) Coherence and synergies between the Programme and Erasmus+ will foster the uptake of research results through training activities, diffuse innovation spirit to the education system and ensure that education and training activities rely on the most updated R&I activities. In that regard, following the pilot actions launched under Erasmus+ 2014-2020 concerning European Universities, the Programme will, where appropriate, complement in a synergetic way the support provided by Erasmus+ to European Universities. (68) In order to increase the impact of the Programme in addressing Union priorities, synergies with programmes and instruments aiming to responding to emerging Union needs should be encouraged and sought, including with the Just Transition Mechanism, the Recovery and Resilience Facility and EU4Health Programme. (69) The rules for participation and dissemination should adequately reflect the needs of the Programme taking into account the concerns raised and the recommendations made by various stakeholders, as well as in the interim evaluation of Horizon 2020 carried out with the assistance of independent external experts. (70) Common rules across the Programme should ensure a coherent framework which facilitates participation in programmes financially supported by the budget of the Programme, including participation in programmes managed by funding bodies such as the EIT, joint undertakings or any other structures under Article 187 TFEU, and participation in programmes undertaken by Member States under Article 185 TFEU. Adopting specific rules should be possible, but such exceptions should be limited to when strictly necessary and duly justified. (71) Actions which fall within the scope of the Programme should respect fundamental rights and observe the principles acknowledged in particular by the Charter of Fundamental Rights of the European Union (the 'Charter'). Such actions should be in conformity with any legal obligation including international law and with any relevant Commission decisions such as the Commission notice of 28 June 2013 (24), as well as with ethical principles, which include avoiding any breach of research integrity. The opinions of the European Group on Ethics in Science and New Technologies, the European Union Agency for Fundamental Rights and the European Data Protection Supervisor should be taken into account, where appropriate. Article 13 TFEU should also be taken into account in research activities, and the use of animals in research and testing should be reduced, with a view ultimately to replacing their use. (72) In order to guarantee scientific excellence, and in line with Article 13 of the Charter, the Programme should promote the respect of academic freedom in all countries benefiting from its funds. (73) In accordance with the objectives of international cooperation as set out in Articles 180 and 186 TFEU, the participation of legal entities established in third countries and of international organisations should be promoted, based on mutual benefits and the Union's interests. The implementation of the Programme should be in conformity with the measures adopted in accordance with Articles 75 and 215 TFEU and should be in compliance with international law. For actions related to Union strategic assets, interests, autonomy or security, it should be possible for participation in specific actions of the Programme to be limited to legal entities established only in Member States or to legal entities established in specified associated or other third countries in addition to Member States. Any exclusion of legal entities established in the Union or in associated countries directly or indirectly controlled by non-associated third countries or by legal entities of non-associated third countries should take into account the risks the inclusion of such entities would represent, on the one hand, and the benefits that their participation would generate, on the other hand. (74) The Programme acknowledges climate change as one of the biggest global and societal challenges and reflects the importance of tackling climate change in accordance with the Union's commitment to implement the Paris Agreement and the SDGs. Accordingly, the Programme should contribute to mainstream climate actions and to the achievement of an overall target of 30 % of the Union budget expenditures supporting climate objectives. Climate mainstreaming should be adequately integrated in R&I content and applied at all stages of the research cycle. (75) In the context of the impact pathway related to climate, the Commission should report on the results, innovations and aggregated estimated effects of projects that are climate-relevant, including by Programme part and by implementation mode. In carrying out its analysis, the Commission should take account of the long-term economic, societal and environmental costs and benefits to Union citizens of activities under the Programme, including the uptake of innovative climate mitigation and adaptation solutions, the estimated impact on jobs and company creation, economic growth and competitiveness, clean energy, health and well-being, including air, soil and water quality. The results of that impact analysis should be made public, should be assessed in the context of the Union's climate and energy goals and should contribute to the subsequent strategic planning and future work programmes. (76) Reflecting the importance of tackling the dramatic loss of biodiversity, R&I activities under the Programme should contribute to the preservation and restoration of biodiversity and to the achievement of the overall ambition of providing 7,5 % of annual spending under the MFF to biodiversity objectives in 2024 and 10 % of annual spending under the MFF to biodiversity objectives in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals in accordance with the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources. (77) Horizontal financial rules adopted by the European Parliament and by the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (78) It is possible that the use of sensitive background information or access by unauthorised individuals to sensitive results have an adverse impact on the interests of the Union or of one or more of the Member States. Thus handling of confidential data and classified information should be governed by all relevant Union law, including the Institutions' internal rules, such as Commission Decision (EU, Euratom) 2015/444 (25). (79) It is necessary to establish the minimum conditions for participation, both as a general rule where a consortium should include at least one legal entity from a Member State, and with regard to the specificities of particular types of action under the Programme. (80) It is necessary to establish the terms and conditions for providing Union funding to participants in actions under the Programme. Grants should be the main form of support in the Programme. They should be implemented taking into account all forms of contribution set out in the Financial Regulation, including lump sums, flat rates or unit costs, with a view to further simplification. The grant agreement should establish the rights and obligations of the beneficiaries, including the role and tasks of the coordinator where applicable. Close cooperation with Member States experts should be ensured in the drawing up of the model grant agreements and in any substantial amendment to them, in view, among other things, of further simplification for beneficiaries. (81) The funding rates in this Regulation are referred to as maximums in order to comply with the co-financing principle. (82) In accordance with the Financial Regulation, the Programme should provide the basis for a wider acceptance of the usual cost-accounting practices of the beneficiaries as regards personnel costs and unit costs for internally invoiced goods and services, including for large research infrastructures within the meaning of Horizon 2020. The use of unit costs for internally invoiced goods and services calculated in accordance with the usual accounting practices of the beneficiaries combining actual direct costs and indirect costs should be an option which could be chosen by all beneficiaries. In that respect, beneficiaries should be able to include actual indirect costs calculated on the basis of allocation keys in such unit costs for internally invoiced goods and services. (83) The current system of reimbursement of actual personnel costs should be further simplified, building on the project-based remuneration approach developed under Horizon 2020, and further aligned to the Financial Regulation, with the aim of reducing the remuneration gap between Union researchers involved in the Programme. (84) The Participant Guarantee Fund set up pursuant to Horizon 2020 and managed by the Commission has proved to be an important safeguard mechanism which mitigates the risks associated with the amounts due and not reimbursed by defaulting participants. Therefore, the Participant Guarantee Fund, renamed the mutual insurance mechanism (the 'Mechanism'), should be continued and enlarged to other funding bodies in particular to initiatives pursuant to Article 185 TFEU. It should be possible to extend the Mechanism to beneficiaries of any other directly managed Union programme. On the basis of close monitoring of the possible negative returns on the investments made by the Mechanism, the Commission should take appropriate mitigating measures in order to allow the Mechanism to continue its interventions for the protection of the financial interests of the Union and to return contributions to beneficiaries at the payment of the balance. (85) Rules governing the exploitation and dissemination of results should be laid down to ensure that beneficiaries protect, exploit, disseminate and provide access to those results as appropriate. More emphasis should be placed on to exploiting those results, and the Commission should identify and help maximise opportunities for beneficiaries to exploit results, in particular in the Union. The exploitation of results should take into consideration the principles of the Programme, including promoting innovation in the Union and strengthening the ERA. (86) The key elements of the proposal evaluation and selection system of Horizon 2020 with its particular focus on excellence and, where applicable, on 'impact' and 'quality and efficiency of implementation', should be maintained. Proposals should continue to be selected based on the evaluation made by independent external experts. The evaluation process should be designed to avoid conflicts of interest and bias. The possibility of a two-stage submission procedure should be taken into account and, where appropriate, anonymised proposals could be evaluated during the first stage of evaluation. The Commission should continue to involve independent observers in the evaluation process, where applicable. For Pathfinder activities, missions and in other duly justified cases as set out in the work programme, the necessity to ensure the overall coherence of the portfolio of projects may be taken into account, provided that the proposals have passed the applicable thresholds. The objectives and procedures for doing so should be published in advance. In accordance with Article 200(7) of the Financial Regulation, applicants should receive feedback on the evaluation of their proposal, including, in particular, where applicable, the reasons for rejection. (87) Systematic cross-reliance on assessments and audits with other Union programmes should be implemented in accordance with Articles 126 and 127 of the Financial Regulation for all parts of the Programme, where possible, in order to reduce administrative burden for beneficiaries of Union funds. Cross-reliance should be explicitly provided for by considering also other elements of assurance such as system and process audits. (88) Specific challenges in the areas of R&I should be addressed by prizes, including common or joint prizes where appropriate, organised by the Commission or the relevant funding body with other Union bodies, associated countries, other third countries, international organisations or non-profit legal entities. Prizes should support the achievement of the objectives of the Programme. (89) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden and the expected risk of non-compliance. This should include consideration of the use of lump sums, flat rates and scales of unit costs. (90) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the MFF 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021. (91) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of avoiding duplication, reaching critical mass in key areas and maximising Union added value, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (92) Regulation (EU) No 1290/2013 of the European Parliament and of the Council (26) and Regulation (EU) No 1291/2013 should therefore be repealed, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter 1. This Regulation establishes Horizon Europe - the Framework Programme for Research and Innovation (the 'Programme') for the duration of the MFF 2021-2027, sets out the rules for participation and dissemination concerning indirect actions under the Programme and determines the framework governing Union support for R&I activities for the same duration. This Regulation lays down the objectives of the Programme, the budget for the period 2021 to 2027, the forms of Union funding and the rules for providing such funding. 2. The Programme shall be implemented through: (a) the specific programme established by Decision (EU) 2021/764; (b) a financial contribution to the European Institute of Innovation and Technology established by the EIT Regulation; (c) the specific programme on defence research established by Regulation (EU) 2021/697. 3. This Regulation does not apply to the specific programme on defence research referred to in point (c) of paragraph 2 of this Article, with the exception of Articles 1 and 5, Article 7(1) and Article 12(1). 4. The terms 'Horizon Europe', 'the Programme' and 'specific programme' used in this Regulation refer to matters relevant only to the specific programme referred to in point (a) of paragraph 2, unless otherwise specified. 5. The EIT shall implement the Programme in accordance with its strategic objectives for the period 2021 to 2027, as laid down in the Strategic Innovation Agenda of the EIT, taking into account the strategic planning referred to in Article 6 and in the specific programme referred to in point (a) of paragraph 2 of this Article. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) 'research infrastructures' means facilities that provide resources and services for the research communities to conduct research and foster innovation in their fields, including the associated human resources, major equipment or sets of instruments; knowledge-related facilities such as collections, archives or scientific data infrastructures; computing systems, communication networks and any other infrastructure of a unique nature and open to external users, essential to achieve excellence in R&I; they may, where relevant, be used beyond research, for example for education or public services and they may be 'single sited', 'virtual' or 'distributed'; (2) 'smart specialisation strategy' means the national or regional innovation strategies which set priorities in order to build competitive advantage by developing and matching R&I own strengths to business needs in order to address emerging opportunities and market developments in a coherent manner, while avoiding duplication and fragmentation of efforts, including those that take the form of, or are included in, a national or regional R&I strategic policy framework, and fulfilling the enabling condition set out in the relevant provisions of the Common Provisions Regulation for 2021-2027; (3) 'European Partnership' means an initiative, prepared with the early involvement of Member States and associated countries, where the Union together with private and/or public partners (such as industry, universities, research organisations, bodies with a public service mission at local, regional, national or international level or civil society organisations including foundations and NGOs) commit to jointly supporting the development and implementation of a programme of R&I activities, including those related to market, regulatory or policy uptake; (4) 'open access' means online access, provided free of charge to the end user, to research outputs resulting from actions under the Programme in accordance with Article 14 and Article 39(3); (5) 'open science' means an approach to the scientific process based on open cooperative work, tools and diffusing knowledge, and includes the elements listed in Article 14; (6) 'mission' means a portfolio of excellence-based and impact-driven R&I activities across disciplines and sectors, intended to: (i) achieve, within a set timeframe, a measurable goal that could not be achieved through individual actions; (ii) have an impact on society and policy-making through science and technology; and (iii) be relevant for a significant part of the European population and a wide range of European citizens; (7) 'pre-commercial procurement' means the procurement of research and development services involving risk-benefit sharing under market conditions, and competitive development in phases, where there is a clear separation of the research and development services procured from the deployment of commercial volumes of end-products; (8) 'public procurement of innovative solutions' means procurement where contracting authorities act as a launch customer for innovative goods or services which are not yet available on a large-scale commercial basis, and may include conformity testing; (9) 'access rights' means rights to use results or background under terms and conditions laid down in accordance with this Regulation; (10) 'background' means any data, know how or information whatever its form or nature, tangible or intangible, including any rights such as intellectual property rights, that is: (i) held by beneficiaries prior to their accession to a given action; and (ii) identified by the beneficiaries in a written agreement as needed for implementing the action or for exploiting its results; (11) 'dissemination' means the public disclosure of the results by appropriate means, other than resulting from protecting or exploiting the results, including by scientific publications in any medium; (12) 'exploitation' means the use of results in further R&I activities other than those covered by the action concerned, including among other things, commercial exploitation such as developing, creating, manufacturing and marketing a product or process, creating and providing a service, or in standardisation activities; (13) 'fair and reasonable conditions' means appropriate conditions, including possible financial terms or royalty-free conditions, taking into account the specific circumstances of the request for access, for example the actual or potential value of the results or background to which access is requested and/or the scope, duration or other characteristics of the exploitation envisaged; (14) 'funding body' means a body or organisation, as referred to in point (c) of Article 62(1) of the Financial Regulation, to which the Commission has entrusted budget implementation tasks under the Programme; (15) 'international European research organisation' means an international organisation, the majority of whose members are Member States or associated countries, whose principal objective is to promote scientific and technological cooperation in Europe; (16) 'legal entity' means a natural person, or a legal person created and recognised as such under Union, national or international law, which has legal personality and the capacity to act in its own name, exercise rights and be subject to obligations, or an entity which does not have legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (17) 'widening countries' or 'low R&I performing countries' means countries where legal entities need to be established in order to be eligible as coordinators under the 'widening participation and spreading excellence' component of the 'Widening Participation and Strengthening ERA' part of the Programme; from the Member States, those countries are Bulgaria, Croatia, Cyprus, Czechia, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia, for the whole duration of the Programme; for associated countries, it means the list of eligible countries as defined based on an indicator and published in the work programme. Legal entities from outermost regions as defined in Article 349 TFUE shall be also fully eligible as coordinators under this component; (18) 'non-profit legal entity' means a legal entity which by its legal form is non-profit-making or which has a legal or statutory obligation not to distribute profits to its shareholders or individual members; (19) 'small or medium-sized enterprise' or 'SME' means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Recommendation 2003/361/EC (27); (20) 'small mid-cap' means an entity that is not an SME and that has up to 499 employees where the staff headcount is calculated in accordance with Articles 3 to 6 of Annex to Recommendation 2003/361/EC; (21) 'results' means any tangible or intangible effect of a given action, such as data, knowhow or information, whatever its form or nature and whether or not it can be protected, as well as any rights attached to it, including intellectual property rights; (22) 'research output' means the results generated by a given action to which access can be given in the form of scientific publications, data or other engineered results and processes such as software, algorithms, protocols and electronic notebooks; (23) 'Seal of Excellence' means a quality label which shows that a proposal submitted to a call for proposals exceeded all of the evaluation thresholds set out in the work programme, but could not be funded due to lack of budget available for that call for proposals in the work programme and might receive support from other Union or national sources of funding; (24) 'strategic R&I plan' means an implementing act laying out a strategy for realising content in the work programme covering a maximum period of four years, follows a broad mandatory multi-stakeholder consultation process and specifies the priorities, suitable types of action and forms of implementation to be used; (25) 'work programme' means a document adopted by the Commission for the implementation of the specific programme in accordance with Article 14 of Decision (EU) 2021/764 or a document equivalent in content and structure adopted by a funding body; (26) 'contract' means an agreement concluded between the Commission or the relevant funding body with a legal entity implementing an innovation and market deployment action and supported by Horizon Europe blended finance or EIC blended finance; (27) 'reimbursable advance' means the part of the Horizon Europe blended finance or EIC blended finance that corresponds to a loan under Title X of the Financial Regulation, but that is directly awarded by the Union on a non-profit basis to cover the costs of activities corresponding to an innovation action, and which is to be reimbursed by the beneficiary to the Union under the conditions provided for in the contract; (28) 'classified information' means European Union classified information as defined in Article 3 of Decision (EU, Euratom) 2015/444 as well as classified information of Member States, classified information of third countries with which the Union has a security agreement and classified information of international organisation with which the Union has a security agreement; (29) 'blending operation' means an action supported by the Union budget, including within a blending facility or platform as defined in point (6) of Article 2 of the Financial Regulation, that combines non-repayable forms of support and/or financial instruments from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; (30) 'Horizon Europe blended finance' means financial support to a programme implementing innovation and market deployment action, consisting of a specific combination of a grant or reimbursable advance and an investment in equity or any other repayable form of support; (31) 'EIC blended finance' means direct financial support provided under the EIC to an innovation and market deployment action consisting of a specific combination of a grant or reimbursable advance and an investment in equity or any other repayable form of support; (32) 'research and innovation action' means an action primarily consisting of activities aiming to establish new knowledge or to explore the feasibility of a new or improved technology, product, process, service or solution. This may include basic and applied research, technology development and integration, testing, demonstration and validation on a small-scale prototype in a laboratory or simulated environment; (33) 'innovation action' means an action primarily consisting of activities directly aiming to produce plans and arrangements or designs for new, altered or improved products, processes or services, possibly including prototyping, testing, demonstrating, piloting, large-scale product validation and market replication; (34) 'ERC frontier research action' means a principal investigator-led research action, including ERC Proof of Concept, hosted by single or multiple beneficiaries receiving funding from the European Research Council (ERC); (35) 'training and mobility action' means an action geared towards the improvement of the skills, knowledge and career prospects of researchers, based on mobility between countries and, if relevant, between sectors or disciplines; (36) 'programme co-fund action' means an action to provide multi-annual co-funding to a programme of activities established or implemented by legal entities managing or funding R&I programmes, other than Union funding bodies; such a programme of activities may support networking and coordination, research, innovation, pilot actions, and innovation and market deployment actions, training and mobility actions, awareness raising and communication, dissemination and exploitation, and provide any relevant financial support, such as grants, prizes and procurement, as well as Horizon Europe blended finance or a combination thereof. The programme co-fund action may be implemented by those legal entities directly or by third parties on their behalf; (37) 'pre-commercial procurement action' means an action the primary aim of which is to realise the pre-commercial procurement implemented by beneficiaries that are contracting authorities or contracting entities; (38) 'public procurement of innovative solutions action' means an action the primary aim of which is to realise the joint or coordinated public procurement of innovative solutions implemented by beneficiaries that are contracting authorities or contracting entities; (39) 'coordination and support action' means an action contributing to the objectives of the Programme, excluding R&I activities, except when undertaken under the component 'widening participation and spreading excellence' of the part 'Widening participation and strengthening the ERA'; and bottom-up coordination without co-funding of research activities from the Union that allows for cooperation between legal entities from Member States and associated countries in order to strengthen the ERA; (40) 'inducement prize' means a prize to spur investment in a given direction by specifying a target prior to the performance of the work; (41) 'recognition prize' means a prize to reward past achievements and outstanding work after it has been performed; (42) 'innovation and market deployment action' means an action which embeds an innovation action and other activities necessary to deploy an innovation in the market, including the scaling-up of companies, Horizon Europe blended finance or EIC blended finance; (43) 'indirect actions' means R&I activities to which the Union provides financial support and which are undertaken by participants; (44) 'direct actions' means R&I activities undertaken by the Commission through its JRC; (45) 'procurement' means procurement as defined in point (49) of Article 2 of the Financial Regulation; (46) 'affiliated entity' means an entity as defined in Article 187(1) of the Financial Regulation; (47) 'innovation ecosystem' means an ecosystem that brings together at Union level actors or entities whose functional goal is to enable technology development and innovation; it encompasses relations between material resources (such as funds, equipment, and facilities), institutional entities (such as higher education institutions and support services, research and technology organisations, companies, venture capitalists and financial intermediaries) and national, regional and local policy-making and funding entities; (48) 'project-based remuneration' means remuneration that is linked to the participation of a person in projects, is part of the beneficiary's usual remuneration practices and is paid in a consistent manner. Article 3 Programme objectives 1. The general objective of the Programme is to deliver scientific, technological, economic and societal impact from the Union's investments in R&I so as to strengthen the scientific and technological bases of the Union and foster the competitiveness of the Union in all Member States including in its industry, to deliver on the Union strategic priorities and to contribute to the realisation of Union objectives and policies, to tackle global challenges, including the SDGs by following the principles of the 2030 Agenda and the Paris Agreement, and to strengthen the ERA. The Programme shall thus maximise Union added value by focusing on objectives and activities that cannot be effectively realised by Member States acting alone, but in cooperation. 2. The Programme has the following specific objectives: (a) to develop, promote and advance scientific excellence, to support the creation and diffusion of high-quality new fundamental and applied knowledge, of skills, technologies and solutions, to support training and mobility of researchers, to attract talent at all levels and contribute to the full engagement of the Union's talent pool in actions supported under the Programme; (b) to generate knowledge, strengthen the impact of R&I in developing, supporting and implementing Union policies and support the access to and uptake of innovative solutions in European industry, in particular SMEs, and in society to address global challenges, including climate change and the SDGs; (c) to foster all forms of innovation, facilitate technological development, demonstration and knowledge and technology transfer, strengthen deployment and exploitation of innovative solutions; (d) to optimise the Programme's delivery with a view to strengthening and increasing the impact and attractiveness of the ERA, to foster excellence-based participation from all Member States, including low R&I performing countries, in the Programme and to facilitate collaborative links in European R&I. Article 4 Programme structure 1. For the specific programme referred to in point (a) of Article 1(2) and the EIT, the Programme shall be structured in parts as follows, which contribute to the general and specific objectives set out in Article 3: (a) Pillar I 'Excellent Science', with the following components: (i) the ERC; (ii) Marie Sk\u0142odowska-Curie Actions (MSCA); (iii) research infrastructures; (b) Pillar II 'Global Challenges and European Industrial Competitiveness', with the following components, taking into account that SSH play an important role across all clusters: (i) cluster 'Health'; (ii) cluster 'Culture, Creativity and Inclusive Society'; (iii) cluster 'Civil Security for Society'; (iv) cluster 'Digital, Industry and Space'; (v) cluster 'Climate, Energy and Mobility'; (vi) cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment'; (vii) non-nuclear direct actions of the JRC; (c) Pillar III 'Innovative Europe', with the following components: (i) the EIC; (ii) European innovation ecosystems; (iii) the EIT; (d) Part 'Widening Participation and Strengthening the ERA', with the following components: (i) widening participation and spreading excellence; (ii) reforming and enhancing the European R&I System. 2. The broad lines of activities of the Programme are set out in Annex I of this Regulation. Article 5 Defence research and development Activities to be carried out under the specific programme referred to in point (c) of Article 1(2) and which are laid down in Regulation (EU) 2021/697, shall have an exclusive focus on defence research and development, with objectives and broad lines of activities aiming to foster the competitiveness, efficiency and innovation capacity of the European defence technological and industrial base. Article 6 Strategic planning and implementation and forms of Union funding 1. The Programme shall be implemented by means of direct management or by means of indirect management by the funding bodies. 2. Funding under the Programme may be provided by means of indirect actions in any of the forms laid down in the Financial Regulation, however grants shall be the main form of support under the Programme. Funding under the Programme may also be provided through prizes, procurements and financial instruments within blending operations and equity support under the Accelerator. 3. The rules for participation and dissemination laid down in this Regulation shall apply to indirect actions. 4. The main types of action to be used under the Programme are defined in Article 2. The forms of funding referred to in paragraph 2 of this Article shall be used in a flexible manner across all objectives of the Programme with their use being determined on the basis of the needs and the characteristics of the particular objectives. 5. The Programme shall also support direct actions. Where those direct actions contribute to initiatives established under Article 185 or 187 TFEU, that contribution shall not be considered to be part of the financial contribution allocated to those initiatives. 6. The implementation of the specific programme referred to in point (a) of Article 1(2) and the EIT's KICs shall be supported by a transparent and strategic planning of R&I activities as laid down in the specific programme referred to in point (a) of Article 1(2), in particular for the pillar 'Global Challenges and European Industrial Competitiveness' and cover also relevant activities in other pillars and the 'Widening participation and strengthening the ERA' part. The Commission shall ensure the early involvement of Member States and extensive exchanges with the European Parliament, to be complemented by consultations with stakeholders and the general public. Strategic planning shall ensure alignment with other relevant Union programmes and consistency with Union priorities and commitments and increase complementarity and synergies with national and regional funding programmes and priorities, thereby strengthening the ERA. Areas for possible missions and areas for possible Institutionalised European Partnerships shall be established in Annex VI. 7. Where appropriate, in order to allow faster access to funds for small collaborative consortia, a fast track to research and innovation procedure (FTRI procedure) may be proposed under some of the calls for proposals dedicated to select research and innovation actions or innovation actions under the pillar 'Global Challenges and European Industrial Competitiveness' and the European Innovation Council Pathfinder. A call for proposals under the FTRI procedure shall have the following cumulative characteristics: (a) bottom-up calls for proposals; (b) a shorter time-to-grant, not exceeding six months; (c) a support provided only to small collaborative consortia composed of maximum six different and independent eligible legal entities; (d) a maximum financial support per consortium not exceeding EUR 2,5 million. The work programme shall identify the calls for proposals which use the FTRI procedure. 8. Activities of the Programme shall be delivered primarily through open, competitive calls for proposals, including within missions and European Partnerships. Article 7 Principles of the Programme 1. Research and innovation activities carried out under the specific programme referred to in point (a) of Article 1(2) and under the EIT shall have an exclusive focus on civil applications. Budgetary transfers between the amount allocated to the specific programme referred to in point (a) of Article 1(2) and the EIT and the amount allocated to the specific programme referred to in point (c) of Article 1(2) shall not be allowed and unnecessary duplication between the two programmes shall be avoided. 2. The Programme shall ensure a multidisciplinary approach and shall, where appropriate, provide for the integration of SSH across all clusters and activities developed under the Programme, including specific calls for proposals on SSH related topics. 3. The collaborative parts of the Programme shall ensure a balance between lower and higher TRLs, thereby covering the whole value chain. 4. The Programme shall ensure the effective promotion and integration of cooperation with third countries and international organisations and initiatives based on mutual benefits, the Union interests, international commitments and, where appropriate, reciprocity. 5. The Programme shall assist widening countries to increase their participation in it and to promote a broad geographical coverage in collaborative projects, including through spreading scientific excellence, boosting new collaborative links, stimulating brain circulation as well as through the implementation of Article 24(2) and Article 50(5). Those efforts shall be mirrored by proportional measures by Member States, including through setting attractive salaries for researchers, with the support of Union, national and regional funds. Without undermining the excellence criteria, particular attention shall be paid to geographical balance, subject to the situation in the field of R&I concerned, in evaluation panels and bodies such as boards and expert groups. 6. The Programme shall ensure the effective promotion of equal opportunities for all and the implementation of gender mainstreaming, including the integration of the gender dimension in R&I content. It shall aim to address the causes of gender imbalance. Particular attention shall be paid to ensuring, to the extent possible, gender balance in evaluation panels and in other relevant advisory bodies such as boards and expert groups. 7. The Programme shall be implemented in synergy with other Union programmes while aiming for maximal administrative simplification. A non-exhaustive list of synergies with other Union programmes is included in Annex IV. 8. The Programme shall contribute to increasing public and private investment in R&I in Member States, thereby helping to reach an overall investment of at least 3 % of Union GDP in research and development. 9. When implementing the Programme, the Commission shall continue to aim for administrative simplification and a reduction of the burden for the applicants and beneficiaries. 10. As part of the general Union objective of mainstreaming climate actions into Union sectoral policies and Union funds, actions under this Programme shall contribute at least 35 % of the expenditure to climate objectives where appropriate. Climate mainstreaming shall be adequately integrated in R&I content. 11. The Programme shall promote co-creation and co-design through the engagement of citizens and civil society. 12. The Programme shall ensure transparency and accountability of public funding in R&I projects, thereby preserving the public interest. 13. The Commission or the relevant funding body shall ensure that sufficient guidance and information is made available to all potential participants at the time of publication of the call for proposals, in particular the applicable model grant agreement. Article 8 Missions 1. Missions shall be programmed within the pillar 'Global Challenges and European Industrial Competitiveness', but may also benefit from actions carried out within other parts of the Programme as well as complementary actions carried out under other Union programmes. Missions shall allow for competing solutions, resulting in pan-European added value and impact. 2. Missions shall be defined and implemented in accordance with this Regulation and the specific programme, ensuring the active and early involvement of the Member States and extensive exchanges with the European Parliament. The missions, their objectives, budget, targets, scope, indicators and milestones shall be identified in strategic R&I plans or the work programmes as appropriate. Evaluations of proposals under the missions shall be carried out in accordance with Article 29. 3. During the first three years of the Programme, a maximum of 10 % of the annual budget of Pillar II shall be programmed through specific calls for proposals for implementing the missions. For the remaining years of the Programme that percentage may be increased subject to a positive assessment of the mission selection and of the management process. The Commission shall communicate the total budgetary share of each work programme dedicated to missions. 4. Missions shall: (a) using SDGs as sources for their design and implementation, have a clear R&I content and Union added value, and contribute to reaching Union priorities and commitments and the Programme objectives referred to in Article 3; (b) cover areas of common European relevance, be inclusive, encourage broad engagement and active participation from various types of stakeholders from the public and private sector, including citizens and end-users, and deliver R&I results that could benefit all Member States; (c) be bold and inspirational, hence have wide, scientific, technological, societal, economic, environmental or policy relevance and impact; (d) indicate a clear direction and clear objectives, be targeted, measurable and time-bound and have a clear budgetary envelope; (e) be selected in a transparent manner and be centred on ambitious, excellence-based and impact-driven, but realistic goals and on research, development and innovation activities; (f) have the necessary scope, scale and mobilisation of the resources and leverage of additional public and private funds required to deliver their outcome; (g) stimulate activities across disciplines (including SSH) and encompass activities from a broad range of TRLs, including lower TRLs; (h) be open to multiple, bottom-up approaches and solutions which take into account human and societal needs and benefits and recognise the importance of diverse contributions to their achievement; (i) benefit from synergies with other Union programmes in a transparent manner as well as with national and, where relevant, regional innovation ecosystems. 5. The Commission shall monitor and evaluate each mission in accordance with Articles 50 and 52 and Annex V, including progress towards short, medium and long-term targets, covering the implementation, monitoring and phasing-out of the missions. An assessment of the first missions established under the Programme shall take place no later than 2023 and before any decision is taken on creating new missions, or on continuing, terminating or redirecting ongoing missions. The results of that assessment shall be made public and shall include, but not be limited to, an analysis of their selection process and of their governance, budget, focus and progress to date. Article 9 The European Innovation Council 1. The Commission shall establish the EIC as a centrally managed one-stop shop for implementing actions under Pillar III 'Innovative Europe' which relate to the EIC. The EIC shall focus mainly on breakthrough and disruptive innovation, targeting especially market-creating innovation, while also supporting all types of innovation, including incremental. The EIC shall operate in accordance with the following principles: (a) clear Union added value; (b) autonomy; (c) ability to take risk; (d) efficiency; (e) effectiveness; (f) transparency; (g) accountability. 2. The EIC shall be open to all types of innovators including individuals, universities, research organisations and companies (SMEs, including start-ups, and, in exceptional cases, small mid-caps) as well as single beneficiaries and multi-disciplinary consortia. At least 70 % of EIC budget shall be dedicated to SMEs, including start-ups. 3. The EIC Board and the management features of the EIC are described in Decision (EU) 2021/764. Article 10 European Partnerships 1. Parts of the Programme may be implemented through European Partnerships. The involvement of the Union in European Partnerships shall take any of the following forms: (a) participation in European Partnerships set up on the basis of memoranda of understanding or contractual arrangements between the Commission and the partners referred to in point (3) of Article 2, specifying the objectives of the European Partnership, related commitments of the Union and of the other partners regarding their financial and/or in-kind contributions, key performance and impact indicators, the results to be delivered and reporting arrangements. They include the identification of complementary R&I activities that are implemented by the partners and by the Programme (Co-programmed European Partnerships); (b) participation in and financial contribution to a programme of R&I activities, specifying the objectives, key performance and impact indicators, and the results to be delivered, based on the commitment of the partners regarding their financial and/or in-kind contributions and the integration of their relevant activities using a Programme co-fund action (Co-funded European Partnerships); (c) participation in and financial contribution to R&I programmes undertaken by several Member States in accordance with Article 185 TFEU or by bodies established pursuant to Article 187 TFEU, such as Joint Undertakings or by the EIT's KICs in accordance with the EIT Regulation (Institutionalised European Partnerships). Institutionalised European Partnerships shall be implemented only where other parts of the Programme, including other forms of European Partnerships, would not achieve the objectives or would not generate the necessary expected impacts, and where justified by a long-term perspective and a high degree of integration. European Partnerships in accordance with Article 185 or Article 187 TFEU shall implement a central management of all financial contributions, except in duly justified cases. In the case of central management of all financial contributions, project level contributions from one participating state shall be made on the basis of the funding requested in proposals from legal entities established in that participating state, unless otherwise agreed among all participating states. The rules for Institutionalised European Partnerships shall specify, among other things, the objectives, key performance and impact indicators, and the results to be delivered, as well as the related commitments for financial and/or in-kind contributions of the partners. 2. European Partnerships shall: (a) be established for the purpose of addressing European or global challenges only in cases where the objectives of the Programme would be achieved more effectively through a European Partnership than by the Union alone and when compared to other forms of support under the Programme; an appropriate share of the budget of the Programme shall be allocated to those actions of the Programme that are implemented through European Partnerships; the majority of the budget in Pillar II shall be allocated to actions outside European Partnerships; (b) adhere to the principles of Union added value, transparency and openness, and to having impact within and for Europe, strong leverage effect on sufficient scale, long-term commitments of all involved parties, flexibility in implementation, coherence, coordination and complementarity with Union, local, regional, national and, where relevant, international initiatives or other European Partnerships and missions; (c) have a clear life-cycle approach, be limited in time and include conditions for phasing-out the Programme funding. 3. European Partnerships under points (a) and (b) of paragraph 1 of this Article shall be identified in strategic R&I plans before being implemented in work programmes. 4. Provisions and criteria for the selection, implementation, monitoring, evaluation and phasing-out of European Partnerships are set out in Annex III. Article 11 Review of missions and partnership areas By 31 December 2023, the Commission shall carry out a review of Annex VI to this Regulation as part of the overall monitoring of the Programme, including missions and Institutionalised European Partnerships established pursuant to Article 185 or 187 TFEU and present a report on the main findings to the European Parliament and to the Council. Article 12 Budget 1. The financial envelope for the implementation of the Programme for the period from 1 January 2021 to 31 December 2027 shall be EUR 86 123 000 000 in current prices for the specific programme referred to in point (a) of Article 1(2) and for the EIT and EUR 7 953 000 000 in current prices for the specific programme referred to in point (c) of Article 1(2). 2. The indicative distribution of the amount referred to in paragraph 1 for the specific programme referred to in point (a) of Article 1(2) and for the EIT shall be: (a) EUR 23 546 000 000 for Pillar I 'Excellent Science' for the period 2021 to 2027, of which: (i) EUR 15 027 000 000 for the ERC; (ii) EUR 6 333 000 000 for MSCA; (iii) EUR 2 186 000 000 for research infrastructures; (b) EUR 47 428 000 000 for Pillar II 'Global Challenges and European Industrial Competitiveness' for the period 2021 to 2027, of which: (i) EUR 6 893 000 000 for cluster 'Health'; (ii) EUR 1 386 000 000 for cluster 'Culture, Creativity and Inclusive Society'; (iii) EUR 1 303 000 000 for cluster 'Civil Security for Society'; (iv) EUR 13 462 000 000 for cluster 'Digital, Industry and Space'; (v) EUR 13 462 000 000 for cluster 'Climate, Energy and Mobility'; (vi) EUR 8 952 000 000 for cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment'; (vii) EUR 1 970 000 000 for the non-nuclear direct actions of the JRC; (c) EUR 11 937 000 000 for Pillar III 'Innovative Europe' for the period 2021 to 2027, of which: (i) EUR 8 752 000 000 for the EIC; (ii) EUR 459 000 000 for European innovation ecosystems; (iii) EUR 2 726 000 000 for the EIT; (d) EUR 3 212 000 000 for Part 'Widening Participation and Strengthening the ERA' for the period 2021 to 2027, of which: (i) EUR 2 842 000 000 for 'widening participation and spreading excellence'; (ii) EUR 370 000 000 for 'reforming and enhancing the European R&I System'. 3. As a result of the Programme specific adjustment provided for in Article 5 of Regulation (EU, Euratom) 2020/2093 the amount referred to in the paragraph 1 for the specific programme referred to in point (a) of Article 1(2) of this Regulation and for the EIT shall be increased by an additional allocation of EUR 3 000 000 000 in constant 2018 prices as specified in Annex II to Regulation (EU, Euratom) 2020/2093. 4. The indicative distribution of the amount referred to in paragraph 3 shall be as follows: (a) EUR 1 286 000 000 in constant 2018 prices for Pillar I 'Excellent Science', of which: (i) EUR 857 000 000 in constant 2018 prices for the ERC; (ii) EUR 236 000 000 in constant 2018 prices for MSCA; (iii) EUR 193 000 000 in constant 2018 prices for research infrastructures; (b) EUR 1 286 000 000 in constant 2018 prices for Pillar II 'Global Challenges and European Industrial Competitiveness', of which: (i) EUR 686 000 000 in constant 2018 prices for cluster 'Culture, Creativity and Inclusive Society'; (ii) EUR 257 000 000 in constant 2018 prices for cluster 'Civil Security for Society'; (iii) EUR 171 000 000 in constant 2018 prices for cluster 'Digital, and Industry and Space'; (iv) EUR 171 000 000 in constant 2018 prices for cluster 'Climate, Energy and Mobility'; (c) EUR 270 000 000 in constant 2018 prices for Pillar III 'Innovative Europe', of which: (i) EUR 60 000 000 in constant 2018 prices for European innovation ecosystems; (ii) EUR 210 000 000 in constant 2018 prices for the EIT; (d) EUR 159 000 000 in constant 2018 prices for Part 'Widening Participation and Strengthening the ERA', of which: (i) EUR 99 000 000 in constant 2018 prices for 'widening participation and spreading sharing excellence'; (ii) EUR 60 000 000 in constant 2018 prices for 'reforming and enhancing the European R&I System'. 5. In order to respond to unforeseen situations or to new developments and needs, the Commission may, within the annual budgetary procedure, deviate from the amounts referred to in paragraph 2 up to a maximum of 10 %. There shall be no such deviation in respect of the amounts referred to in point (b)(vii) of paragraph 2 and the total amount set out for Part 'Widening Participation and Strengthening the ERA' of paragraph 2. 6. The amount referred to in paragraphs 1 and 3 of this Article for the specific programme referred to in point (a) of Article 1(2) and for the EIT, may also cover expenses for preparation, monitoring, control, audit, evaluation and other activities and expenditures necessary for managing and implementing the Programme, including all administrative expenditure, as well as evaluating the achievement of its objectives. The administrative expenses related to indirect actions shall not exceed 5 % of the total amount of indirect actions of the specific programme referred to in point (a) of Article 1(2) and of the EIT. Moreover, the amount referred to in paragraphs 1 and 3 of this Article for the specific programme referred to in point (a) of Article 1(2) and for the EIT may also cover: (a) in so far as they are related to the objectives of the Programme: expenses relating to studies, to meetings of experts, information and communication actions; (b) expenses linked to information technology networks focusing on information processing and exchange, including corporate information technology tools and other technical and administrative assistance needed in connection with the management of the Programme. 7. If necessary to enable the management of actions not completed by 31 December 2027, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in paragraph 6. 8. Budgetary commitments for actions extending over more than one financial year may be broken down into annual instalments over several years. 9. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, in duly justified cases specified in the financing decision and for a limited period, activities supported under this Regulation and the underlying costs may be considered eligible as of 1 January 2021, even if they were implemented and incurred before the grant application was submitted. Article 13 Resources from the European Union Recovery Instrument 1. Subject to Article 3(3), (4), (7) and (9) of Regulation (EU) 2020/2094 the measures referred to in Article 1(2) of that Regulation shall be implemented under the Programme through amounts referred to in point (a)(iv) of Article 2(2) of that Regulation. 2. The amounts referred to in point (a)(iv) of Article 2(2) of Regulation (EU) 2020/2094 shall constitute external assigned revenue as set out in Article 3(1) of that Regulation. Those additional amounts shall exclusively be allocated to actions for R&I directed at addressing the consequences of the COVID-19 crisis, in particular its economic, social and societal consequences. Priority shall be given to innovative SMEs and special attention shall be paid to their integration in collaborative projects under Pillar II. 3. The indicative distribution of the amounts referred to in point (a)(iv) of Article 2(2) of Regulation (EU) 2020/2094 shall be: (a) 25 % to cluster 'Health'; (b) 25 % to cluster 'Digital, Industry and Space'; (c) 25 % to cluster 'Climate, Energy and Mobility'; (d) 25 % to the EIC. Article 14 Open science 1. The Programme shall encourage open science as an approach to the scientific process based on cooperative work and diffusing knowledge, in particular in accordance with the following elements which shall be ensured in accordance with Article 39(3) of this Regulation: (a) open access to scientific publications resulting from research funded under the Programme; (b) open access to research data, including those underlying scientific publications, in accordance with the principle 'as open as possible, as closed as necessary'. 2. The principle of reciprocity in open science shall be promoted and encouraged in all association and cooperation agreements with third countries, including agreements signed by funding bodies entrusted with the indirect management of the Programme. 3. Responsible management of research data shall be ensured in line with the principles 'findability', 'accessibility', 'interoperability' and 'reusability' (the 'FAIR principles'). Attention shall also be paid to the long-term preservation of data. 4. Other open science practices shall be promoted and encouraged, including for the benefit of SMEs. Article 15 Alternative, combined and cumulative funding and transfers of resources 1. The Programme shall be implemented in synergy with other Union programmes, in accordance with the principle set out in Article 7(7). 2. The Seal of Excellence shall be awarded for calls for proposals specified in the work programme. In accordance with the relevant provision of the Common Provisions Regulation for 2021-2027 and the relevant provision of the 'CAP Strategic Plan Regulation', the ERDF, the ESF+ or the EAFRD may support: (a) co-funded actions selected under the Programme; and (b) actions which were awarded a Seal of Excellence provided that they comply with all of the following conditions: (i) they have been assessed in a call for proposals under the Programme; (ii) they comply with the minimum quality requirements of that call for proposals; and (iii) they have not been financed under that call for proposals only due to budgetary constraints. 3. Financial contributions under programmes co-financed by the ERDF, the ESF+, the EMFAF and the EAFRD may be considered to be a contribution of the participating Member State to European Partnerships under points (b) and (c) of Article 10(1) of this Regulation, provided that the relevant provisions of the Common Provisions Regulation for 2021-2027 and the fund-specific regulations are complied with. 4. An action that has received a contribution from another Union programme may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 5. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme subject to the conditions set out in the relevant provisions of the Common Provisions Regulation for 2021-2027. The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. 6. Where the Commission has not entered into a legal commitment under direct or indirect management for resources transferred in accordance with paragraph 5, the corresponding uncommitted resources may be transferred back to one or more respective source programmes, at the request of the Member State, in accordance with the conditions set out in the relevant provisions of the Common Provisions Regulation for 2021-2027. Article 16 Third countries associated to the Programme 1. The Programme shall be open to association of the following third countries (associated countries): (a) Members of the European Free Trade Association, which are members of the EEA, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) third countries and territories that fulfil all of the following criteria: (i) a good capacity in science, technology and innovation; (ii) commitment to a rules-based open market economy, including fair and equitable dealing with intellectual property rights, respect of human rights, backed by democratic institutions; (iii) active promotion of policies to improve the economic and social well-being of citizens. 2. Association to the Programme of each of the third countries under point (d) of paragraph 1 shall be in accordance with the conditions laid down in an agreement covering the participation of the third country to any Union programme, provided that the agreement: (a) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (b) lays down the conditions of participation in the Union programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (c) does not confer on the third country any decision-making power in respect of the Union programme; (d) guarantees the rights of the Union to ensure sound financial management and to protect the Union's financial interests. The contributions referred to in point (b) of the first subparagraph of this paragraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. 3. The scope of association of each third country to the Programme shall take into account an analysis of the benefits for the Union and the objective of driving economic growth in the Union through innovation. Accordingly, with the exception of EEA members, acceding countries, candidate countries and potential candidates, parts of the Programme may be excluded from an association agreement for a specific country. 4. The association agreement shall, as far as possible, provide for the reciprocal participation of legal entities established in the Union in equivalent programmes of associated countries in accordance with the conditions laid down in those programmes. 5. The conditions determining the level of financial contribution shall ensure a regular automatic correction of any significant imbalance compared to the amount that entities established in the associated country receive through participation in the Programme, taking into account the costs in the management, execution and operation of the Programme. The allocation of the financial contributions shall take into account the level of participation of the legal entities of the associated countries in each part of the Programme. TITLE II RULES FOR PARTICIPATION AND DISSEMINATION CHAPTER I General provisions Article 17 Funding bodies and direct actions of JRC 1. The rules set out in this Title do not apply to direct actions undertaken by the JRC. 2. In duly justified cases, funding bodies may depart from the rules set out in this Title, except for Articles 18, 19 and 20, if: (a) such a departure is provided for in the basic act setting up the funding body or entrusting budget implementation tasks to it; or (b) for funding bodies under points (ii), (iii) or (v) of point (c) of Article 62(1) of the Financial Regulation if it is provided for in the contribution agreement and if their specific operating needs or the nature of the action so require. Article 18 Eligible actions and ethical principles 1. Without prejudice to paragraph 2 of this Article, only actions implementing the objectives referred to in Article 3 shall be eligible for funding. The following fields of research shall not be financed: (a) activities aiming at human cloning for reproductive purposes; (b) activities intended to modify the genetic heritage of human beings which could make such modifications heritable (28); (c) activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer. 2. Research on human stem cells, both adult and embryonic, may be financed depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be provided within or outside the Union for research activities that are prohibited in all Member States. No funding shall be provided in a Member State for a research activity which is forbidden in that Member State. Article 19 Ethics 1. Actions carried out under the Programme shall comply with ethical principles and relevant Union, national and international law, including the Charter and the European Convention for the Protection of Human Rights and Fundamental Freedoms and its Supplementary Protocols. Particular attention shall be paid to the principle of proportionality, to the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination and to the need to ensure protection of the environment and high levels of human health protection. 2. Legal entities participating in an action shall provide: (a) an ethics self-assessment identifying and detailing all the foreseeable ethics issues related to the objective, implementation and likely impact of the activities to be funded, including a confirmation of compliance with paragraph 1 and a description of how it will be ensured; (b) a confirmation that the activities will comply with the European Code of Conduct for Research Integrity published by All European Academies and that no activities excluded from funding will be conducted; (c) for activities carried out outside the Union, a confirmation that the same activities would have been allowed in a Member State; and (d) for activities making use of human embryonic stem cells, as appropriate, details of licensing and control measures that shall be taken by the competent authorities of the Member States concerned as well as details of the ethics approvals that shall be obtained before the activities concerned start. 3. Proposals shall be systematically screened to identify actions which raise complex or serious ethics issues and submit them to an ethics assessment. The ethics assessment shall be carried out by the Commission unless it is delegated to the funding body. All actions involving the use of human embryonic stem cells or human embryos shall be subject to an ethics assessment. Ethics screenings and assessments shall be carried out with the support of ethics experts. The Commission and the funding bodies shall ensure the transparency of the ethics procedures without prejudice to the confidentiality of the content of those procedures. 4. Legal entities participating in an action shall obtain all approvals or other mandatory documents from the relevant national, local ethics committees or other bodies, such as data protection authorities, before the start of the relevant activities. Those documents shall be kept on file and provided to the Commission or the relevant funding body upon request. 5. If appropriate, ethics checks shall be carried out by the Commission or the relevant funding body. For serious or complex ethics issues, ethics checks shall be carried out by the Commission unless the Commission delegates this task to the funding body. Ethics checks shall be carried out with the support of ethics experts. 6. Actions which do not fulfil the ethics requirements referred to in paragraphs 1 to 4 and are therefore not ethically acceptable, shall be rejected or terminated once the ethical unacceptability has been established. Article 20 Security 1. Actions carried out under the Programme shall comply with the applicable security rules and in particular rules on the protection of classified information against unauthorised disclosure, including compliance with any relevant Union and national law. In the case of research carried out outside the Union using or generating classified information, it shall also be necessary that, in addition to the compliance with those requirements, a security agreement shall have been concluded between the Union and the third country in which the research is to be conducted. 2. Where appropriate, proposals shall include a security self-assessment identifying any security issues and detailing how those issues will be addressed in order to comply with the relevant Union and national law. 3. Where appropriate, the Commission or the relevant funding body shall carry out a security scrutiny procedure for proposals raising security issues. 4. Where appropriate, the actions carried out under the Programme shall comply with Decision (EU, Euratom) 2015/444 and its implementing rules. 5. Legal entities participating in an action shall ensure the protection against unauthorised disclosure of classified information used or generated by the action. They shall provide proof of personal security clearance or facility security clearance from the relevant national security authorities, prior to the start of the activities concerned. 6. If independent external experts have to deal with classified information, the appropriate security clearance shall be required before those experts are appointed. 7. Where appropriate, the Commission or the relevant funding body may carry out security checks. 8. Actions which do not comply with the security rules under this Article may be rejected or terminated at any time. CHAPTER II Grants Article 21 Grants Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation, unless otherwise specified in this Chapter. Article 22 Legal entities eligible for participation 1. Any legal entity, regardless of its place of establishment and including legal entities from non-associated third countries or international organisations, may participate in actions under the Programme, provided that the conditions laid down in this Regulation have been met together with any conditions laid down in the work programme or call for proposals. 2. Except in duly justified cases where the work programme otherwise provides, legal entities forming a consortium shall be eligible for participation in actions under the Programme provided that the consortium includes: (a) at least one independent legal entity established in a Member State; and (b) at least two other independent legal entities each established in different Member States or associated countries; 3. ERC frontier research actions, EIC actions, training and mobility actions or programme co-fund actions may be implemented by one or more legal entities, provided that one of those legal entities shall be established in a Member State or associated country on the basis of an agreement concluded in accordance with Article 16. 4. Coordination and support actions may be implemented by one or more legal entities, which may be established in a Member State, associated country or, in exceptional cases, in another third country. 5. For actions related to Union strategic assets, interests, autonomy or security, the work programme may provide that the participation can be limited to legal entities established only in Member States or to legal entities established in specified associated or other third countries in addition to Member States. Any limitation of the participation of legal entities established in associated countries which are EEA members shall be in accordance with the terms and conditions of the Agreement on the European Economic Area. For duly justified and exceptional reasons, in order to guarantee the protection of the strategic interests of the Union and its Member States, the work programme may also exclude the participation of legal entities established in the Union or in associated countries directly or indirectly controlled by non-associated third countries or by legal entities of non-associated third countries from individual calls for proposals, or make their participation subject to conditions set out in the work programme. 6. Where appropriate and duly justified, the work programme may provide for eligibility criteria in addition to those set out in paragraphs 2 to 5 to take into account specific policy requirements or the nature and objectives of the action, including the number of legal entities, the type of legal entity and the place of establishment. 7. For actions benefiting from amounts under Article 15(5), the participation shall be limited to a single legal entity established in the jurisdiction of the delegating managing authority, except if otherwise agreed with that managing authority. 8. Where indicated in the work programme, the JRC may participate in actions. 9. The JRC, international European research organisations and legal entities created under Union law shall be deemed to be established in a Member State other than the ones in which other legal entities participating in the action are established. 10. For ERC frontier research actions, training and mobility actions and when provided for in the work programme, international organisations with headquarters in a Member State or associated country shall be deemed to be established in that Member State or associated country. For other parts of the Programme, international organisations other than international European research organisations shall be deemed to be established in a non-associated third country. Article 23 Legal entities eligible for funding 1. Legal entities shall be eligible for funding if they are established in a Member State or an associated country. Only legal entities established in the jurisdiction of the delegating managing authority shall be eligible for funding for actions benefiting from amounts under Article 15(5), except if otherwise agreed by that managing authority. 2. Legal entities established in a non-associated third country shall bear the cost of their participation. However, a legal entity established in low to middle income non-associated third countries and, exceptionally, other non-associated third countries, shall be eligible for funding in an action if: (a) the third country is identified in the work programme adopted by the Commission; or (b) the Commission or the relevant funding body considers that the participation of the legal entity concerned is essential for implementing the action. 3. Affiliated entities are eligible for funding in an action if they are established in a Member State, an associated country or in a third country identified in the work programme adopted by the Commission. 4. The Commission shall make available on a regular basis to the European Parliament and to the Council information concerning the amount of the Union's financial contributions provided to legal entities established in associated and non-associated third countries. As regards associated countries, that information shall also include information on their financial balance. Article 24 Calls for proposals 1. The content of the calls for proposals for all actions shall be included in the work programme. 2. If necessary to achieve their objectives, calls for proposals may, in exceptional cases, be restricted in order to develop additional activities or to add additional partners to existing actions. In addition, the work programme may provide for the possibility for legal entities from low R&I performing countries to join already selected collaborative R&I actions, subject to the agreement of the respective consortium and provided that legal entities from such countries are not yet participating in it. 3. A call for proposals is not required for coordination and support actions or programme co-fund actions which: (a) are to be carried out by the JRC or legal entities identified in the work programme; (b) do not fall within the scope of a call for proposals, in accordance with point (e) of Article 195 of the Financial Regulation. 4. The work programme shall specify calls for proposals for which Seals of Excellence may be awarded. With prior authorisation from the applicant, information concerning the application and the evaluation may be shared with interested financing authorities, subject to the conclusion of confidentiality agreements. Article 25 Joint calls for proposals The Commission or the relevant funding body may issue a joint call for proposals with: (a) third countries, including their scientific and technological organisations or agencies; (b) international organisations; (c) non-profit legal entities. In the case of a joint call for proposals, the applicants shall fulfil the requirements under Article 22 and joint procedures shall be established for the selection and evaluation of proposals. Such procedures shall involve a balanced group of experts appointed by each party. Article 26 Pre-commercial procurement and public procurement of innovative solutions 1. Actions may involve or have as their primary aim the pre-commercial procurement or public procurement of innovative solutions that shall be carried out by beneficiaries which are contracting authorities or contracting entities as defined in Directives 2014/24/EU (29) and 2014/25/EU (30) of the European Parliament and of the Council. 2. The procurement procedures: (a) shall comply with competition rules and with the principles of transparency, non-discrimination, equal treatment, sound financial management, proportionality; (b) may authorise the award of multiple contracts within the same procedure (multiple sourcing); (c) shall provide for the award of the contracts to the tenders offering best value for money while ensuring absence of conflicts of interest. In the case of pre-commercial procurement, where appropriate and without prejudice to the principles enumerated in point (a), the procurement procedure may be simplified or accelerated and may provide for specific conditions such as limiting the place of performance of the procured activities to the territory of the Member States and of the associated countries. 3. The contractor generating results in pre-commercial procurement shall own at least the intellectual property rights attached to those results. The contracting authorities shall enjoy at least royalty-free access rights to the results for their own use and the right to grant, or require the participating contractors to grant, non-exclusive licences to third parties to exploit the results for the contracting authority under fair and reasonable conditions without any right to sub-license. If a contractor fails to commercially exploit the results within a given period after the pre-commercial procurement as identified in the contract, the contracting authorities, after having consulted the contractor on the reasons for the non-exploitation, may require it to transfer any ownership of the results to the contracting authorities. Article 27 Financial capacity of applicants 1. In addition to the exceptions mentioned in Article 198(5) of the Financial Regulation, the financial capacity shall be verified only for the coordinator and only if the requested funding from the Union for the action is equal to or greater than EUR 500 000. 2. Notwithstanding paragraph 1, if there are grounds to doubt the financial capacity of an applicant, or if there is a higher risk due to the participation in several ongoing actions funded by Union R&I programmes, the Commission or the relevant funding body shall also verify the financial capacity of other applicants, or of coordinators even where the requested funding is below the threshold referred to in paragraph 1. 3. If the financial capacity is structurally guaranteed by another legal entity, the financial capacity of that other legal entity shall be verified. 4. In the case where the financial capacity of an applicant is weak, the Commission or the relevant funding body may make participation of the applicant conditional on provision of a declaration on joint and several liability by an affiliated entity. 5. The contribution to the Mechanism set out in Article 37 of this Regulation shall be considered to be a sufficient guarantee under Article 152 of the Financial Regulation. No additional guarantee or security shall be accepted from beneficiaries or imposed upon them. Article 28 Award criteria and selection 1. A proposal shall be evaluated on the basis of the following award criteria: (a) excellence; (b) impact; (c) quality and efficiency of the implementation. 2. Only the criterion referred to in point (a) of paragraph 1 shall apply to proposals for ERC frontier research actions. 3. The work programme shall lay down further details concerning the application of the award criteria laid down in paragraph 1 including any weighting, thresholds and where relevant rules for dealing with ex aequo proposals, taking into consideration the objectives of the call for proposals. The conditions for dealing with ex aequo proposals may include, but shall not be limited to, the following criteria: SMEs, gender, and geographical diversity. 4. The Commission and other funding bodies shall take into account the possibility of a two-stage submission and evaluation procedure and where appropriate, anonymised proposals may be evaluated during the first stage of evaluation based on one or more of the award criteria referred to in paragraph 1. Article 29 Evaluation 1. Proposals shall be evaluated by the evaluation committee which shall be composed of independent external experts. For EIC activities, missions and in duly justified cases as set out in the work programme adopted by the Commission, the evaluation committee may be composed partially or, in the case of coordination and support actions, partially or fully of representatives of Union institutions or bodies as referred to in Article 150 of the Financial Regulation. The evaluation process may be followed by independent observers. 2. Where applicable, the evaluation committee shall rank the proposals that have passed the applicable thresholds, according to: (a) the evaluation scores; (b) their contribution to the achievement of specific policy objectives, including the constitution of a consistent portfolio of projects namely for Pathfinder activities, missions and in other duly justified cases as set out in the work programme adopted by the Commission in detail. For EIC activities, missions and in other duly justified cases as set out in the work programme adopted by the Commission in detail, the evaluation committee may also propose adjustments to the proposals insofar as those adjustments are needed for the consistency of the portfolio approach. Those adjustments shall be in conformity with the conditions for participation and comply with the principle of equal treatment. The Programme Committee shall be informed of such cases. 3. The evaluation process shall be designed to avoid conflicts of interest and bias. The transparency of the evaluation criteria and of the proposal scoring method shall be guaranteed. 4. In accordance with Article 200(7) of the Financial Regulation, applicants shall receive feedback at all stages of the evaluation and, where the proposal is rejected, the reasons for rejection. 5. Legal entities established in low R&I performing countries who have participated successfully in the component 'widening participation and spreading excellence' shall receive, upon request, a record of their participation, that may accompany proposals to the collaborative parts of the Programme that they coordinate. Article 30 Evaluation review procedure, enquiries and complaints 1. An applicant may request an evaluation review if it considers that the applicable evaluation procedure has not been correctly applied to its proposal (31). 2. Only the procedural aspects of an evaluation may be the subject of a request for an evaluation review. The evaluation of the merits of a proposal shall not be the subject of an evaluation review. 3. A request for an evaluation review shall relate to a specific proposal and shall be submitted within 30 days after the communication of evaluation results. An evaluation review committee shall provide an opinion on the procedural aspects of the evaluation, and shall be chaired by and include staff of the Commission or of the relevant funding body who were not involved in the evaluation of the proposals. The evaluation review committee may recommend one of the following: (a) a re-evaluation of the proposal to be carried out primarily by evaluators who were not involved in the previous evaluation; or (b) confirmation of the initial evaluation. 4. An evaluation review shall not delay the selection process for proposals that are not the subject of that review. 5. The Commission shall ensure the existence of a procedure for participants to make direct enquiries and complaints about their involvement in the Programme. Information on how to register enquiries or complaints shall be made available online. Article 31 Time-to-grant 1. By way of derogation from the first subparagraph of Article 194(2) of the Financial Regulation, the following periods shall apply: (a) for informing all applicants of the outcome of the evaluation of their application, a maximum period of five months from the final date for submission of complete proposals; (b) for signing grant agreements with applicants, a maximum period of eight months from the final date for submission of complete proposals. 2. The work programme may establish shorter periods than those provided for in paragraph 1. 3. In addition to the exceptions laid down in the second subparagraph of Article 194(2) of the Financial Regulation, the periods referred to in paragraph 1 of this Article may be exceeded for actions of the ERC, for missions and when actions are submitted to an ethics assessment or security scrutiny. Article 32 Implementation of the grant 1. If a beneficiary fails to comply with its obligations regarding the technical implementation of the action, the other beneficiaries shall comply with those obligations without any additional Union funding, unless they are expressly relieved of that obligation. The financial responsibility of each beneficiary shall be limited to its own debt subject to the provisions relating to the Mechanism. 2. The grant agreement may establish milestones and related pre-financing instalments. If milestones are not reached, the action may be suspended, amended, or, where duly justified, terminated. 3. An action may also be terminated where expected results have lost their relevance for the Union for scientific or technological reasons or, in the case of the Accelerator, also for economic reasons or, in the case of EIC and missions, also due to their relevance as part of a portfolio of actions. The Commission shall undergo a procedure with the action coordinator and, if appropriate, with independent external experts, before deciding to terminate an action, in accordance with Article 133 of the Financial Regulation. Article 33 Grant agreements 1. The Commission shall, in close cooperation with Member States, draw up model grant agreements between the Commission or the relevant funding body and the beneficiaries in accordance with this Regulation. If a significant modification of a model grant agreement is required, in view, among other things, of further simplification for beneficiaries, the Commission shall, in close cooperation with Member States, revise that model grant agreement as appropriate. 2. Grant agreements shall establish the rights and obligations of the beneficiaries and of either the Commission or the relevant funding body in compliance with this Regulation. They shall also establish the rights and obligations of legal entities which become beneficiaries during the implementation of the action, as well as the role and tasks of a coordinator. Article 34 Funding rates 1. A single funding rate per action shall apply for all activities it funds. The maximum rate per action shall be fixed in the work programme. 2. Up to 100 % of total eligible costs of an action under the Programme may be reimbursed, except for: (a) innovation actions where, up to 70 % of the total eligible costs may be reimbursed, except for non-profit legal entities where up to 100 % of the total eligible costs may be reimbursed; (b) programme co-fund actions where, at least 30 % and, in identified and duly justified cases, up to 70 % of the total eligible costs may be reimbursed. 3. The funding rates determined in this Article shall also apply for actions where flat-rate, unit or lump-sum financing is fixed for the whole action or part thereof. Article 35 Indirect costs 1. Indirect eligible costs shall be 25 % of the total direct eligible costs, excluding direct eligible costs for subcontracting, financial support to third parties and any unit costs or lump sums which include indirect costs. Where appropriate, indirect costs included in unit costs or lump sums shall be calculated using the flat rate referred to in the first subparagraph, except for unit costs for internally invoiced goods and services, which shall be calculated on the basis of actual costs, in accordance with the beneficiaries' usual cost accounting practice. 2. Notwithstanding paragraph 1, if provided for in the work programme, indirect costs may be declared in the form of a lump sum or unit costs. Article 36 Eligible costs 1. In addition to the criteria set out in Article 186 of the Financial Regulation, for beneficiaries with project-based remuneration, personnel costs are eligible up to the remuneration that the person would be paid for work in R&I projects funded by national schemes including social security charges and other costs linked to the remuneration of personnel assigned to the action, arising from national law or from the employment contract. 2. By way of derogation from Article 190(1) of the Financial Regulation, costs of resources made available by third parties by means of in-kind contributions shall be eligible up to the direct eligible costs of the third party. 3. By way of derogation from Article 192 of the Financial Regulation, income generated by the exploitation of the results shall not be considered to be receipts of the action. 4. Beneficiaries may use their usual accounting practices to identify and declare the costs incurred in relation to an action in compliance with all terms and conditions set out in the grant agreement, in accordance with this Regulation and Article 186 of the Financial Regulation. 5. By way of derogation from Article 203(4) of the Financial Regulation, a certificate on the financial statements shall be mandatory at payment of the balance, if the amount claimed as actual costs and unit costs calculated in accordance with usual cost accounting practices is equal to or greater than EUR 325 000. Certificates on financial statements may be produced by an approved external auditor or, in the case of public bodies, issued by a competent and independent public officer in accordance with Article 203(4) of the Financial Regulation. 6. Where appropriate, for MSCA training and mobility actions, the Union contribution shall take due account of any additional costs of the beneficiary related to maternity leave, parental leave, sick leave, special leave or to a change of recruiting host organisation or a change in the family status of researcher during the duration of the grant agreement. 7. Costs related to open access including data management plans shall be eligible for reimbursement as further stipulated in the grant agreement. Article 37 Mutual insurance mechanism 1. A mutual insurance mechanism (the 'Mechanism') is hereby established which shall replace and succeed the fund set up in accordance with Article 38 of Regulation (EU) No 1290/2013. The Mechanism shall cover the risk associated with non-recovery of sums due by the beneficiaries: (a) to the Commission under Decision No 1982/2006/EC of the European Parliament and of the Council (32); (b) to the Commission and Union bodies under 'Horizon 2020'; (c) to the Commission and funding bodies under the Programme. The coverage of the risk regarding the funding bodies referred to in point (c) of the first subparagraph may be implemented through an indirect coverage system set out in the applicable agreement and taking into account the nature of the funding body. 2. The Mechanism shall be managed by the Union, represented by the Commission acting as executive agent. The Commission shall set up specific rules for the operation of the Mechanism. 3. Beneficiaries shall make a contribution of 5 % of the Union funding for the action. On the basis of periodic transparent evaluations, the Commission may increase that contribution up to 8 % or reduce it to under 5 %. The contribution of the beneficiaries to the Mechanism shall be offset against the initial pre-financing and paid to the Mechanism on behalf of the beneficiaries. That contribution shall not exceed the amount of the initial pre-financing. 4. The contribution of the beneficiaries shall be returned at the payment of the balance. 5. Any financial return generated by the Mechanism shall be added to the Mechanism. If the return is insufficient the Mechanism shall not intervene, and the Commission or the relevant funding body shall recover any amount owed directly from the beneficiaries or third parties. 6. The amounts recovered shall constitute revenue assigned to the Mechanism within the meaning of Article 21(5) of the Financial Regulation. Once all grants for which the risk is covered directly or indirectly by the Mechanism are completed, any sums outstanding shall be recovered by the Commission and entered into the budget of the Union, subject to decisions of the legislative authority. 7. The Mechanism may be extended to beneficiaries of any other directly managed Union programme. The Commission shall adopt conditions for participation of beneficiaries of other programmes. Article 38 Ownership and protection 1. Beneficiaries shall own the results they generate. They shall ensure that any rights of their employees or any other parties in relation to the results can be exercised in a manner compatible with the beneficiaries' obligations in the grant agreement. Two or more beneficiaries shall own results jointly where: (a) they have jointly generated them; and (b) it is not possible to: (i) establish the respective contribution of each beneficiary; or (ii) separate them when applying for, obtaining or maintaining their protection. The joint owners shall agree in writing on the allocation and terms of exercise of their joint ownership. Unless otherwise agreed in the consortium agreement or in the joint ownership agreement, each joint owner may grant non-exclusive licences to third parties to exploit the jointly-owned results (without any right to sub-license), if the other joint owners are given advance notice and fair and reasonable compensation. The joint owners may agree in writing to apply another regime than joint ownership. 2. Beneficiaries which have received Union funding shall adequately protect their results if protection is possible and justified, taking into account all relevant considerations, including the prospects for commercial exploitation and any other legitimate interests. When deciding on protection, beneficiaries shall also consider the legitimate interests of the other beneficiaries in the action. Article 39 Exploitation and dissemination 1. Each beneficiary that has received Union funding shall use its best efforts to exploit the results it owns, or to have them exploited by another legal entity. Exploitation may be direct by the beneficiaries or indirect in particular through the transfer and licensing of results in accordance with Article 40. The work programme may provide for additional exploitation obligations. If, despite a beneficiary's best efforts to exploit its results directly or indirectly, the results are not exploited within a given period as established in the grant agreement, the beneficiary shall use an appropriate online platform as identified in the grant agreement to find interested parties to exploit those results. That obligation may be waived at the request of the beneficiary if justified. 2. Beneficiaries shall disseminate their results as soon as feasible, in a publicly available format, subject to any restrictions due to the protection of intellectual property, security rules or legitimate interests. The work programme may provide for additional dissemination obligations while safeguarding the Union's economic and scientific interests. 3. Beneficiaries shall ensure that open access to scientific publications applies under the terms and conditions laid down in the grant agreement. In particular, the beneficiaries shall ensure that they or the authors retain sufficient intellectual property rights to comply with their open access requirements. Open access to research data shall be the general rule under the terms and conditions laid down in the grant agreement, ensuring the possibility of exceptions following the principle 'as open as possible, as closed as necessary', taking into consideration the legitimate interests of the beneficiaries including commercial exploitation and any other constraints, such as data protection rules, privacy, confidentiality, trade secrets, Union competitive interests, security rules or intellectual property rights. The work programme may provide for additional incentives or obligations for the purpose of adhering to open science practices. 4. Beneficiaries shall manage all research data generated in an action under the Programme in line with the FAIR principles and in accordance with the grant agreement and shall establish a Data Management Plan. The work programme may provide, where justified, for additional obligations to use the EOSC for storing and giving access to research data. 5. Beneficiaries that intend to disseminate their results shall give advance notice to the other beneficiaries in the action. Any other beneficiary may object if it can show that dissemination of the results would significantly harm its legitimate interests in relation to its results or background. In such cases, the results shall not be disseminated unless appropriate steps are taken to safeguard those legitimate interests. 6. Unless the work programme provides otherwise, proposals shall include a plan for the exploitation and dissemination of the results. If the expected exploitation of the results entails developing, creating, manufacturing and marketing a product or process, or in creating and providing a service, the plan shall include a strategy for such exploitation. If the plan provides for the exploitation of the results primarily in non-associated third countries, the legal entities shall explain how that exploitation is still to be considered to be in the Union interest. The beneficiaries shall update the plan for the exploitation and dissemination of the results during and after the end of the action, in accordance with the grant agreement. 7. For the purposes of monitoring and dissemination by the Commission or the relevant funding body, the beneficiaries shall provide any information requested regarding the exploitation and dissemination of their results, in accordance with the grant agreement. Subject to the legitimate interests of the beneficiaries, such information shall be made publicly available. Article 40 Transfer and licensing 1. Beneficiaries may transfer ownership of their results. They shall ensure that their obligations also apply to the new owner and that the latter has the obligation to pass them on in any subsequent transfer. 2. Unless otherwise agreed in writing for specifically identified third parties including affiliated entities or unless impossible under applicable law, beneficiaries that intend to transfer ownership of results shall give advance notice to any other beneficiary that still has access rights to the results. The notification shall include sufficient information on the new owner to enable a beneficiary to assess the effects on its access rights. Unless otherwise agreed in writing for specifically identified third parties including affiliated entities, a beneficiary may object to the transfer of ownership of results by another beneficiary if it can show that the transfer would adversely affect its access rights. In this case, the transfer shall not take place until agreement has been reached between the beneficiaries concerned. The grant agreement shall lay down time limits in this respect. 3. Beneficiaries may grant licences to their results or otherwise give the right to exploit them, including on an exclusive basis, if this does not affect compliance with their obligations. Exclusive licences for results may be granted subject to consent by all the other beneficiaries concerned that they will waive their access rights thereto. 4. Where justified, the grant agreement shall provide for the right for the Commission or the relevant funding body to object to transfers of ownership of results, or to grants of an exclusive licence regarding results, if: (a) the beneficiaries which generated the results have received Union funding; (b) the transfer or licensing is to a legal entity established in a non-associated third country; and (c) the transfer or licensing is not in line with Union interests. If the right to object is provided for, the beneficiary shall give advance notice of its intention to transfer ownership of results or to grant an exclusive licence regarding results. The right to object may be waived in writing regarding transfers or grants to specifically identified legal entities if measures safeguarding Union interests are in place. Article 41 Access rights 1. Requests to exercise access rights and the waiver of access rights shall be in writing. 2. Unless otherwise agreed with the grantor, access rights shall not include the right to sub-license. 3. Before acceding to the grant agreement the beneficiaries shall inform each other of any restrictions to granting access to their background. 4. If a beneficiary is no longer involved in an action, this shall not affect its obligations to grant access. 5. If a beneficiary defaults on its obligations, the beneficiaries may agree that that beneficiary no longer has access rights. 6. Beneficiaries shall grant access to: (a) their results on a royalty-free basis to any other beneficiary in the action that needs them to implement its own tasks; (b) their background to any other beneficiary in the action that needs it to implement its own tasks, subject to any restrictions referred to in paragraph 3; that access shall be granted on a royalty-free basis, unless otherwise agreed by the beneficiaries before their accession to the grant agreement; (c) their results and, subject to any restrictions referred to in paragraph 3, to their background to any other beneficiary in the action that needs them to exploit its own results; that access shall be granted under fair and reasonable conditions to be agreed upon. 7. Unless otherwise agreed by the beneficiaries, they shall also grant access to their results and, subject to any restrictions referred to in paragraph 3, to their background to a legal entity that: (a) is established in a Member State or associated country; (b) is under the direct or indirect control of another beneficiary, or is under the same direct or indirect control as that beneficiary, or is directly or indirectly controlling that beneficiary; and (c) needs the access to exploit the results of that beneficiary, in accordance with the beneficiary's exploitation obligations. Access shall be granted under fair and reasonable conditions to be agreed upon. 8. A request for access for exploitation purposes may be made up to one year after the end of the action, unless the beneficiaries agree on a different time limit. 9. Beneficiaries that have received Union funding shall grant access to their results on a royalty-free basis to the Union institutions, bodies, offices or agencies for developing, implementing and monitoring Union policies or programmes. Access shall be limited to non-commercial and non-competitive use. Such access rights shall not extend to the beneficiaries' background. In actions under the cluster 'Civil Security for Society', beneficiaries that have received Union funding shall also grant access to their results on a royalty-free basis to Member States' national authorities, for developing, implementing and monitoring their policies or programmes in that area. Access shall be limited to non-commercial and non-competitive use and shall be subject to a bilateral agreement defining specific conditions aimed at ensuring that those access rights are used only for the intended purpose and that appropriate confidentiality obligations are in place. The requesting Member State, Union institution, body, office or agency shall notify all Member States of such requests. 10. The work programme may provide, where appropriate, for additional access rights. Article 42 Specific provisions 1. Specific provisions on ownership, exploitation and dissemination, transfer and licensing as well as access rights may apply for ERC actions, training and mobility actions, pre-commercial procurement actions, public procurement of innovative solutions actions, programme co-fund actions and coordination and support actions. 2. The specific provisions referred to in paragraph 1 shall be set out in the grant agreement and shall not change the principles and obligations on open access. Article 43 Prizes 1. Unless otherwise specified in this Chapter, inducement or recognition prizes under the Programme shall be awarded and managed in accordance with Title IX of the Financial Regulation. 2. Unless otherwise provided in the work programme or the contest rules, any legal entity, regardless of its place of establishment, may participate in a contest. 3. The Commission or the relevant funding body may, where appropriate, organise prize contests with: (a) other Union bodies; (b) third countries, including their scientific and technological organisations or agencies; (c) international organisations; or (d) non-profit legal entities. 4. Work programmes or contest rules shall include obligations regarding communication and, where appropriate, exploitation and dissemination, ownership and access rights including licensing provisions. CHAPTER III Procurement Article 44 Procurement 1. Unless otherwise specified in this Chapter, procurement under the Programme shall be carried out in accordance with Title VII of the Financial Regulation. 2. Procurement may also take the form of pre-commercial procurement or public procurement of innovative solutions carried out by the Commission or the relevant funding body on its own behalf or jointly with contracting authorities from Member States and associated countries. In such cases, the rules set out in Article 26 shall apply. CHAPTER IV Blending operations and blended finance Article 45 Blending operations Blending operations under the Programme shall be implemented in accordance with the InvestEU Programme and Title X of the Financial Regulation. Article 46 Horizon Europe blended finance and EIC blended finance 1. The grant and reimbursable advance components of Horizon Europe blended finance and EIC blended finance shall be subject to Articles 34 to 37. 2. EIC blended finance shall be implemented in accordance with Article 48 of this Regulation. Support under EIC blended finance may be granted until the action can be financed as a blending operation or as a financing and investment operation fully covered by the Union guarantee under the InvestEU Programme. By way of derogation from Article 209 of the Financial Regulation, the conditions laid down in paragraph 2 of that Article and, in particular points (a) and (d) thereof, do not apply at the time of the award of EIC blended finance. 3. Horizon Europe blended finance may be awarded to a programme co-fund action where a joint programme of Member States and associated countries provides for the deployment of financial instruments in support of selected actions. The evaluation and selection of such actions shall be made in accordance with Articles 15, 23, 24, 27, 28 and 29. The conditions for implementation of Horizon Europe blended finance shall comply with Article 32, by analogy with Article 48(10) and with any additional and justified conditions set out in the work programme. 4. Repayments including reimbursed advances and revenues of Horizon Europe blended finance and EIC blended finance shall be considered to be internal assigned revenues in accordance with point (f) of Article 21(3) and Article 21(4) of the Financial Regulation. 5. Horizon Europe blended finance and EIC blended finance shall be provided in a manner that promotes the Union's competitiveness while not distorting competition in the internal market. Article 47 The Pathfinder 1. The Pathfinder shall provide grants to high-risk cutting-edge projects, implemented by consortia or single beneficiaries, aiming to develop radical innovations and new market opportunities. The Pathfinder shall provide support for the earliest stages of scientific, technological or deep-tech research and development, including proof of concept and prototypes for technology validation. The Pathfinder shall be implemented mainly through an open call for proposals for bottom-up proposals with regular cut-off dates per year and shall also provide for competitive challenges to develop key strategic objectives calling for deep-tech and radical thinking. 2. The Pathfinder's transition activities shall help all types of researchers and innovators develop the pathway to commercial development in the Union, such as demonstration activities and feasibility studies to assess potential business cases, and shall support the creation of spin-offs and start-ups. The launch and the content of the calls for proposals for Pathfinder's transition activities shall be determined taking account of objectives and budget established by the work programme in relation with the portfolio of actions concerned. Additional grants for a fixed amount not exceeding EUR 50 000 may be awarded to each proposal already selected under the Pathfinder, and where relevant Pathfinder's transition activities, through a call for proposals to carry out complementary activities, including urgent coordination and support actions, for reinforcing the portfolio's community of beneficiaries, such as assessing possible spin-offs, potential market-creating innovations or developing a business plan. The Programme Committee established under the specific programme shall be informed of such cases. 3. The award criteria referred to in Article 28 shall apply to the Pathfinder. Article 48 The Accelerator 1. The Accelerator shall aim to support essentially market-creating innovation. It shall support only single beneficiaries and shall mainly provide blended finance. Under certain conditions, it may also provide grant-only and equity-only supports. The Accelerator shall provide the following types of support: (a) blended finance support to SMEs, including start-ups, and, in exceptional cases, small mid-caps, carrying out breakthrough and disruptive non-bankable innovation; (b) a grant-only support to SMEs, including start-ups, carrying out any type of innovation ranging from incremental to breakthrough and disruptive innovation and aiming to subsequently scale-up; (c) equity-only support to non-bankable SMEs, including start-ups, which have already received a grant-only support, may also be provided. Grant-only support under the Accelerator shall be provided only under the following cumulative conditions: (a) the project shall include information on the capacities and willingness of the applicant to scale-up; (b) the beneficiary shall be a start-up or an SME; (c) a grant-only support under the Accelerator shall be provided only once to a beneficiary during the period of implementation of the Programme for a maximum of EUR 2,5 million. 2. The beneficiary of the Accelerator shall be a legal entity qualifying as a start-up, an SME or in exceptional cases as a small mid-cap intending to scale up, established in a Member State or associated country. The proposal may be submitted either by the beneficiary or, subject to the prior agreement by the beneficiary, by one or more natural persons or legal entities intending to establish or support that beneficiary. In the latter case, the funding agreement shall be signed only with the beneficiary. 3. A single award decision shall cover and provide funding for all forms of Union contribution provided under EIC blended finance. 4. Proposals shall be evaluated on their individual merits by independent external experts and selected for funding through an open call for proposals with cut-off dates, based on Articles 27, 28 and 29, subject to paragraph 5 of this Article. 5. The proposals submitted shall be evaluated on the basis of the following award criteria: (a) excellence; (b) impact; (c) the level of risk of the action that would prevent investments, the quality and efficiency of the implementation, and the need for Union support. 6. With the agreement of the applicants concerned, the Commission or the funding bodies implementing the Programme (including the EIT's KICs) may directly submit for evaluation under the award criterion referred to in point (c) of paragraph 5 a proposal for an innovation and market deployment action which already fulfils the award criteria referred to in points (a) and (b) of paragraph 5, subject to the following cumulative conditions: (a) the proposal shall stem from any other action funded under Horizon 2020, from the Programme or, subject to an exploratory pilot phase to be launched under the first work programme, from national and/or regional programmes, starting with the mapping of the demand for such a scheme, detailed provisions of which shall be laid down in the specific programme referred to in point (a) of Article 1(2); (b) the proposal is based on a project review which was carried out within the previous two years assessing the excellence and the impact of the proposal and subject to conditions and processes further detailed in the work programme. 7. A Seal of Excellence may be awarded subject to the following cumulative conditions: (a) the beneficiary is a start-up, an SME or a small mid-cap; (b) the proposal was eligible and has passed the applicable thresholds for the award criteria referred to in points (a) and (b) of paragraph 5; (c) the activity would be eligible under an innovation action. 8. For a proposal having passed the evaluation, independent external experts shall propose a corresponding Accelerator support, based on the risk incurred and the resources and time necessary to bring and deploy the innovation to the market. The Commission may reject, for justified reasons, a proposal retained by independent external experts, including due to non-compliance with the objectives of Union policies. The Programme Committee shall be informed of the reasons for such a rejection. 9. The grant or the reimbursable advance component of the Accelerator support shall not exceed 70 % of the total eligible costs of the selected innovation action. 10. The conditions for implementation of the equity and the repayable support components of the Accelerator support are set out in Decision (EU) 2021/764 11. The contract for the selected action shall establish specific measurable milestones and the corresponding pre-financing and payments by instalments of the Accelerator support. In the case of EIC blended finance, activities corresponding to an innovation action may be launched and the first pre-financing of the grant or the reimbursable advance paid, prior to the implementation of other components of the awarded EIC blended finance. The implementation of those components shall be subject to reaching specific milestones established in the contract. 12. In accordance with the contract, the action shall be suspended, amended or, if duly justified, terminated if measurable milestones are not reached. It may also be terminated where the expected market deployment, especially in the Union, cannot be met. In exceptional cases and upon advice by the EIC board, the Commission may decide to increase the Accelerator support subject to a project review by independent external experts. The Programme Committee shall be informed of such cases. CHAPTER V Experts Article 49 Appointment of independent external experts 1. Independent external experts shall be identified and selected on the basis of calls for expression of interest from individuals and through calls addressed to relevant organisations such as research agencies, research institutions, universities, standardisation organisations, civil society organisations or enterprises with a view to establishing a database of candidates. By way of derogation from Article 237(3) of the Financial Regulation, the Commission or the relevant funding body may, exceptionally and in duly justified cases, select in a transparent manner any individual expert with the appropriate skills not included in the database provided that a call for expression of interest has not identified suitable independent external experts. Such experts shall declare their independence and capacity to support the objectives of the Programme. 2. In accordance with Article 237(2) and (3) of the Financial Regulation, the independent external experts shall be remunerated based on standard conditions. If justified, and in exceptional cases, an appropriate level of remuneration beyond the standard conditions based on relevant market standards, especially for specific high-level experts, may be granted. Such costs shall be covered by the Programme. 3. In addition to the information referred to in Article 38(2) and (3) of the Financial Regulation, the names of independent external experts evaluating grant applications who are appointed in a personal capacity shall be published, together with their area of expertise, at least once a year on the website of the Commission or of the funding body. Such information shall be collected, processed and published in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (33). 4. The Commission or the relevant funding body shall take the appropriate measures to prevent conflicts of interest as regards the involvement of independent external experts in accordance with Article 61 and Article 150(5) of the Financial Regulation. The Commission or the relevant funding body shall ensure that an expert faced with a conflict of interest in relation to a matter on which the expert is required to provide an opinion does not evaluate, advise or assist on the specific matter in question. 5. When appointing independent external experts, the Commission or the relevant funding body shall take appropriate measures to seek a balanced composition within the expert groups and evaluation panels in terms of skills, experience, knowledge, including in terms of specialisation, in particular on SSH, geographical diversity and gender, taking into account the situation in the field of the action. 6. Where appropriate, an adequate number of independent external experts shall be ensured for each proposal in order to guarantee the quality of the evaluation. 7. The information on the level of remuneration of all independent external experts shall be made available to the European Parliament and to the Council. TITLE III PROGRAMME MONITORING, COMMUNICATION, EVALUATION AND CONTROL Article 50 Monitoring and reporting 1. The Commission shall monitor continuously the management and implementation of the Programme, the specific programme referred to in point (a) of Article 1(2) and the activities of the EIT. In order to enhance transparency, data shall also be made publicly available in an accessible manner on the Commission's website according to the latest update. In particular, data for projects funded under ERC, European Partnerships, missions, the EIC and the EIT shall be included in the same database. The database shall include: (a) time-bound indicators to report on an annual basis on the progress of the Programme towards achievement of the objectives referred to in Article 3 and set out in Annex V along impact pathways; (b) information on the level of mainstreaming SSH, the ratio between lower and higher TRLs in collaborative research, the progress on the participation of widening countries, the geographical composition of consortia in collaborative projects, the evolution of researchers salaries, the use of a two-stage submission and evaluation procedure, the measures aimed at facilitating collaborative links in European R&I, the use of the evaluation review and the number and types of complaints, the level of climate mainstreaming and related expenditures, SME participation, private sector participation, gender participation in funded actions, evaluation panels, boards and advisory groups, the 'Seals of Excellence', the European Partnerships as well as the co-funding rate, the complementary and cumulative funding from other Union programmes, research infrastructures, time-to-grant, the level of international cooperation, engagement of citizens and civil society participation; (c) the levels of expenditure disaggregated at project level in order to allow for specific analysis, including per intervention area; (d) the level of oversubscription, in particular the number of proposals and per call for proposals, their average score, the share of proposals above and below quality thresholds. 2. To ensure the effective assessment of the Programme's progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts in accordance with Article 55 to amend Annex V with regard to the impact pathway indicators, where considered to be necessary, and to set baselines and targets as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 3. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively and in a timely manner, without increasing the administrative burden for beneficiaries. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds, including at the level of researchers involved in the actions in order to be able to track their career and mobility, and where appropriate, on Member States. 4. Qualitative analysis from the Commission and Union or national funding bodies shall complement as much as possible quantitative data. 5. The measures aimed at facilitating collaborative links in European R&I shall be monitored and reviewed in the context of the work programmes. Article 51 Information, communication, publicity and dissemination and exploitation 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results (including for prizes), by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the Programme, to actions under the Programme and to the results obtained. In addition, it shall provide timely and thorough information to Member States and beneficiaries. Evidence-based matchmaking services informed by analytics and network affinities shall be provided to interested entities in order to form consortia for collaborative projects, with particular attention to identifying networking opportunities for legal entities from low R&I performing countries. On the basis of such analysis, targeted matchmaking events may be organised in function of specific calls for proposals. 3. The Commission shall also establish a dissemination and exploitation strategy for increasing the availability and diffusion of the Programme's R&I results and knowledge to accelerate exploitation towards market uptake and boost the impact of the Programme. 4. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union as well as information, communication, publicity, dissemination and exploitation activities insofar as those priorities are related to the objectives referred to in Article 3. Article 52 Programme evaluation 1. Programme evaluations shall be carried out in a timely manner to feed into the decision-making process of the Programme, the next framework programme and other initiatives relevant to R&I. 2. The interim evaluation of the Programme shall be carried out with the assistance of independent experts selected on the basis of a transparent process once there is sufficient information available about the implementation of the Programme, but no later than four years after the start of that implementation. It shall include a portfolio analysis and an assessment of the long-term impact of previous framework programmes and shall form the basis to adjust or re-orientate the Programme, as appropriate. It shall assess the Programme's effectiveness, efficiency, relevance, coherence, and Union added value. 3. At the end of the implementation of the Programme, but no later than four years after the end of the period specified in Article 1, a final evaluation of the Programme shall be completed by the Commission. It shall include an assessment of the long-term impact of previous framework programmes. 4. The Commission shall publish and communicate the conclusions of the evaluations accompanied by its observations and shall present them to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 53 Audits 1. The control system for the Programme shall ensure an appropriate balance between trust and control, taking into account administrative and other costs of controls at all levels, especially for beneficiaries. Audit rules shall be clear, consistent and coherent throughout the Programme. 2. The audit strategy for the Programme shall be based on the financial audit of a representative sample of expenditure across the Programme as a whole. The representative sample shall be complemented by a selection based on an assessment of the risks related to expenditure. Actions that receive joint funding from different Union programmes shall be audited only once, covering all programmes involved and their respective applicable rules. 3. In addition, the Commission or the relevant funding body may rely on system and processes audits at beneficiary level. Those audits shall be optional for certain types of beneficiaries and shall examine the systems and processes of a beneficiary, complemented by an audit of transactions. They shall be carried out by a competent independent auditor qualified to carry out statutory audits of accounting documents in accordance with Directive 2006/43/EC of the European Parliament and of the Council (34). The system and processes audits may be used by the Commission or the relevant funding body to determine the overall assurance on the sound financial management of expenditure and for reconsideration of the level of ex post audits and certificates on financial statements. 4. In accordance with Article 127 of the Financial Regulation, the Commission or the relevant funding body may rely on audits on the use of Union contributions carried out by other independent and competent persons or entities, including by other than those mandated by the Union institutions or bodies. 5. Audits may be carried out up to two years after the payment of the balance. 6. The Commission shall publish audit guidelines, aiming to ensure the reliable and uniform application and interpretation of the audit procedures and rules throughout the duration of the Programme. Article 54 Protection of financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 55 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 50(2) shall be conferred on the Commission until 31 December 2028. 3. The delegation of power referred to in Article 50(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 50(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. TITLE IV TRANSITIONAL AND FINAL PROVISIONS Article 56 Repeal Regulations (EU) No 1290/2013 and (EU) No 1291/2013 are repealed with effect from 1 January 2021. Article 57 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulations (EU) No 1290/2013 and (EU) No 1291/2013, which shall continue to apply to those actions until their closure. Work plans and actions provided for in work plans adopted under Regulation (EU) No 1290/2013 and under the corresponding funding bodies' basic acts shall also continue to be governed by Regulation (EU) No 1290/2013 and those basic acts until their completion. 2. The financial envelope for the Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted pursuant to Regulation (EU) No 1291/2013. Article 58 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 28 April 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 62, 15.2.2019, p. 33 and OJ C 364, 28.10.2020, p. 124. (2) OJ C 461, 21.12.2018, p. 79. (3) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and position of the Council at first reading of 16 March 2021 (not yet published in the Official Journal). Position of the European Parliament of \u2026 (not yet published in the Official Journal). (4) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (5) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433 I, 22.12.2020, p. 23). (6) OJ L 282, 19.10.2016, p. 4. (7) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104). (8) OJ C 331, 18.9.2018, p. 30. (9) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (10) Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 (see page 149 of this Official Journal). (11) Council Decision (EU) 2021/764 of 10 May 2021 on establishing the specific programme implementing Horizon Europe \u2013 the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (OJ LI 167, 12.5.2021, p. 1). (12) OJ L 433 I, 22.12.2020, p. 28. (13) OJ C 444 I, 22.12.2020, p. 1. (14) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (15) Communication from the Commission of 14 February 2018 entitled 'A new, modern Multiannual Financial Framework for a European Union that deliver efficiently on its priorities post-2020' identifies EUR 13 billion spent in main digital activities under the Research and Innovation Framework Programme Horizon 2020. (16) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (17) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (18) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (19) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor's Office ('the EPPO') (OJ L 283, 31.10.2017, p. 1). (20) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (21) OJ L 1, 3.1.1994, p. 3. (22) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union ('Overseas Association Decision') (OJ L 344, 19.12.2013, p. 1). (23) OJ L 123, 12.5.2016, p. 1. (24) OJ C 205, 19.7.2013, p. 9. (25) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (26) Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in 'Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020)' and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81). (27) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (28) Research relating to cancer treatment of the gonads can be financed. (29) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (30) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (31) The procedure will be explained in a document published before the start of the evaluation process. (32) Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1). (33) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (34) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87). ANNEX I BROAD LINES OF ACTIVITIES The general and specific objectives referred to in Article 3 of this Regulation shall be pursued across the Programme, through the areas of intervention and the broad lines of activities described in this Annex and in Annex II to this Regulation, as well as in Annex I to Decision (EU) 2021/764. (1) Pillar I 'Excellent Science' Through the following activities, this pillar shall, in line with Article 4, promote scientific excellence, attract the best talent to Europe, provide appropriate support to early-stage researchers and support the creation and diffusion of scientific excellence, high-quality knowledge, methodologies and skills, technologies and solutions to global social, environmental and economic challenges. It shall also contribute to the other specific objectives of the Programme as referred to in Article 3. (a) ERC: providing attractive and flexible funding to enable talented and creative individual researchers, with an emphasis on early stage researchers, and their teams to pursue the most promising avenues at the frontier of science, regardless of their nationality and country of origin and on the basis of Union-wide competition based solely on the criterion of excellence. Area of intervention: Frontier science. (b) MSCA: equipping researchers with new knowledge and skills through mobility and exposure across borders, sectors and disciplines, enhancing training and career development systems as well as structuring and improving institutional and national recruitment, taking into account the European Charter for Researchers and the Code of Conduct for the recruitment of researchers; in so doing, the MSCA help to lay the foundations of Europe's excellent research landscape across the whole of Europe, contributing to boosting jobs, growth, and investment, and solving current and future societal challenges. Areas of intervention: nurturing excellence through the mobility of researchers across borders, sectors and disciplines; fostering new skills through the excellent training of researchers; strengthening human resources and skills development across the ERA; improving and facilitating synergies; promoting public outreach. (c) Research infrastructures: endowing Europe with world-class sustainable research infrastructures which are open and accessible to the best researchers from Europe and beyond. Encouraging the use of existing research infrastructures, including those financed from funds under Union Cohesion Policy. In so doing, enhancing the potential of the research infrastructure to support scientific advance and innovation, and to enable open and excellent science in accordance with the FAIR principles, alongside activities related to Union policies and international cooperation. Areas of intervention: consolidating and developing the landscape of European research infrastructures; opening, integrating and interconnecting research infrastructures; the innovation potential of European research infrastructures and activities for innovation and training; reinforcing European research infrastructure policy and international cooperation. (2) Pillar II 'Global Challenges and European Industrial Competitiveness' Through the following activities, this pillar shall, in line with Article 4, support the creation and better diffusion of high-quality new knowledge, technologies and sustainable solutions, reinforce the European industrial competitiveness, strengthen the impact of R&I in developing, supporting and implementing Union policies, and support the uptake of innovative solutions in industry, in particular in SMEs and start-ups, and society to address global challenges. It shall also contribute to the other specific objectives of the Programme as referred to in Article 3. SSH shall be fully integrated across all clusters, including specific and dedicated activities. To maximise impact, flexibility and synergies, R&I activities shall be organised in six clusters, interconnected through pan-European research infrastructures, which individually and together incentivise interdisciplinary, cross-sectoral, cross-policy, cross-border and international cooperation. Pillar II of the Programme shall cover activities from a broad range of TRLs, including lower TRLs. Each cluster contributes towards several SDGs and many SDGs are supported by more than one cluster. The R&I activities shall be implemented in and across the following clusters: (a) Cluster 'Health': improving and protecting the health and well-being of citizens of all ages by generating new knowledge, developing innovative solutions, ensuring to integrate, where relevant, a gender perspective to prevent, diagnose, monitor, treat and cure diseases, and developing health technologies; mitigating health risks; protecting populations and promoting good health and well-being, also in the work place; making public health systems more cost-effective, equitable and sustainable; preventing and tackling poverty-related diseases; and supporting and enabling patients' participation and self-management. Areas of intervention: health throughout the life course; environmental and social health determinants; non-communicable and rare diseases; infectious diseases, including poverty-related and neglected diseases; tools, technologies and digital solutions for health and care, including personalised medicine; health care systems. (b) Cluster 'Culture, Creativity and Inclusive Society': strengthening democratic values, including rule of law and fundamental rights; safeguarding our cultural heritage; exploring the potential of cultural and creative sectors, and promoting socio-economic transformations that contribute to inclusion and growth, including migration management and integration of migrants. Areas of intervention: democracy and governance; culture, cultural heritage and creativity; social and economic transformations. (c) Cluster 'Civil Security for Society': responding to the challenges arising from persistent security threats, including cybercrime, as well as natural and man-made disasters. Areas of intervention: disaster-resilient societies; protection and security; cybersecurity. (d) Cluster 'Digital, Industry and Space': reinforcing capacities and securing Europe's sovereignty in key enabling technologies for digitisation and production, and in space technology, all along the value chain; to build a competitive, digital, low-carbon and circular industry; ensure a sustainable supply of raw materials; develop advanced materials and provide the basis for advances and innovation in global societal challenges. Areas of intervention: manufacturing technologies; key digital technologies, including quantum technologies; emerging enabling technologies; advanced materials; artificial intelligence and robotics; next generation internet; advanced computing and Big Data; circular industries; low carbon and clean industries; space, including earth observation. (e) Cluster 'Climate, Energy and Mobility': fighting climate change by better understanding its causes, evolution, risks, impacts and opportunities, by making the energy and transport sectors more climate and environment-friendly, more efficient and competitive, smarter, safer and more resilient, promote the use of renewable energy sources and energy efficiency, improve the resilience of the Union to external shocks and adapt social behaviour in view of the SDGs. Areas of intervention: climate science and solutions; energy supply; energy systems and grids; buildings and industrial facilities in energy transition; communities and cities; industrial competitiveness in transport; clean, safe and accessible transport and mobility; smart mobility; energy storage. (f) Cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment': protecting the environment, restoring, sustainably managing and using natural and biological resources from land, inland waters and sea to stop biodiversity erosion, to address food and nutrition security for all and the transition to a low carbon, resource efficient and circular economy and sustainable bioeconomy. Areas of intervention: environmental observation; biodiversity and natural resources; agriculture, forestry and rural areas; seas, oceans and inland waters; food systems; bio-based innovation systems in the Union's bioeconomy; circular systems. (g) Non-nuclear direct actions of the JRC: generating high-quality scientific evidence for efficient and affordable good public policies. New initiatives and proposals for Union legal acts need transparent, comprehensive and balanced evidence to be sensibly designed, whereas implementation of policies needs evidence to be measured and monitored. The JRC provides Union policies with independent scientific evidence and technical support throughout the policy cycle. The JRC focuses its research on Union policy priorities. Areas of intervention: strengthening the knowledge base for policy making; global challenges (health; culture, creativity and inclusive society; civil security for society; digital, industry and space; climate, energy and mobility; food, bioeconomy, natural resources, agriculture and environment); innovation, economic development, and competitiveness; scientific excellence; territorial development and support for Member States and regions. (3) Pillar III 'Innovative Europe' Through the following activities, this pillar shall, in line with Article 4, foster all forms of innovation, including non-technological innovation, primarily within SMEs including start-ups, by facilitating technological development, demonstration and knowledge transfer, and strengthen deployment of innovative solutions. It shall also contribute to the other specific objectives of the Programme as referred to in Article 3. The EIC shall be implemented primarily through two instruments, the Pathfinder, implemented mainly through collaborative research, and the Accelerator. (a) EIC: focusing mainly on breakthrough and disruptive innovation, targeting especially market-creating innovation, while also supporting all types of innovation, including incremental innovation. Areas of intervention: Pathfinder for advanced research, supporting future and emerging breakthrough, market-creating and/or deep tech technologies; the Accelerator, bridging the financing gap between late stages of R&I activities and market take-up, to effectively deploy breakthrough, market-creating innovation and scale up companies where the market does not provide viable financing; additional EIC activities such as prizes and fellowships, and business added-value services. (b) European innovation ecosystems Areas of intervention: activities including in particular connecting, where relevant in cooperation with the EIT, with national and regional innovation actors and supporting the implementation of joint cross-border innovation programmes by Member States, Regions and associated countries, from the exchange of practice and knowledge on innovation regulation to the enhancement of soft skills for innovation to research and innovation activities, including open or user-led innovation, to boost the effectiveness of the European innovation system. This should be implemented in synergy with, among others, the ERDF support for innovation eco-systems and interregional partnerships around smart specialisation topics. (c) The European Institute of Innovation and Technology Areas of intervention (defined in Annex II): sustainable innovation ecosystems across Europe; innovation and entrepreneurial skills in a lifelong learning perspective, including increasing capacities of higher education institutions across Europe; new solutions to market to address global challenges; synergies and value added within the Programme. (4) Part 'Widening Participation and Strengthening the ERA' Through the following activities, this part shall pursue the specific objectives as set out in point (d) of Article 3(2). It shall also contribute to the other specific objectives of the Programme as referred to in Article 3. While underpinning the entire Programme, this part shall support activities that contribute to attracting talent, fostering brain circulation and preventing brain drain, a more knowledge-based and innovative and gender-equal Europe, at the front edge of global competition, fostering transnational cooperation and thereby optimising national strengths and potential across the whole Europe in a well-performing ERA, where knowledge and a highly skilled workforce circulate freely in a balanced manner, where the results of R&I are widely disseminated to as well as understood and trusted by informed citizens and benefit society as a whole, and where Union policy, in particular R&I policy, is based on high quality scientific evidence. This Part shall also support activities aimed at improving the quality of proposals from legal entities from low R&I performing countries, such as professional pre-proposal checks and advice, and boosting the activities of National Contact Points to support international networking, as well as activities aimed at supporting legal entities from low R&I performing countries joining already selected collaborative projects in which legal entities from such countries are not participating. Areas of intervention: widening participation and spreading excellence, including through teaming, twinning, ERA-Chairs, European Cooperation in Science and Technology (COST), excellence initiatives and activities to foster brain circulation; reforming and enhancing the European R&I system, including through for example supporting national R&I policy reform, providing attractive career environments, and supporting gender and citizen science. ANNEX II EUROPEAN INSTITUTE OF INNOVATION AND TECHNOLOGY (EIT) The following shall apply in the implementation of the programme activities of the EIT: (1) Rationale As the report of the High Level Group on maximising the impact of Union R&I (the Lamy High Level Group) clearly states, the way forward is 'to educate for the future and invest in people who will make the change'. In particular, European higher education institutions are called to stimulate entrepreneurship, tear down disciplinary borders and institutionalise strong inter-disciplinary academia-industry collaborations. According to recent surveys, access to talented people is by far the most important factor influencing the location choices of European founders of start-ups. Entrepreneurship education, training opportunities and the development of creative skills play a key role in cultivating future innovators and in developing the abilities of existing ones to grow their business to greater levels of success. Access to entrepreneurial talent, together with access to professional services, capital and markets on the Union level, and bringing key innovation actors together around a common goal are key ingredients for nurturing an innovation ecosystem. There is a need to coordinate efforts across the Union in order to create a critical mass of interconnected Union-wide entrepreneurial clusters and ecosystems. The EIT is today's Europe's largest integrated innovation ecosystem which brings together partners from business, research, education and beyond. The EIT continues to support its KICs, which are large-scale European Partnerships addressing specific global challenges, and strengthen the innovation ecosystems around them. It does so by fostering the integration of education, R&I of the highest standards, thereby creating environments conducive to innovation, and by promoting and supporting a new generation of entrepreneurs and stimulating the creation of innovative companies in close synergy and complementarity with the EIC. Throughout Europe, efforts are still needed to develop ecosystems where researchers, innovators, industries and governments can easily interact. Innovation ecosystems, in fact, still do not work optimally due to a number of reasons such as: (a) interaction among innovation players is still hampered by organisational, regulatory and cultural barriers between them; (b) efforts to strengthen innovation ecosystems shall benefit from coordination and a clear focus on specific objectives and impact. To address future societal challenges, embrace the opportunities of new technologies and contribute to environmentally friendly and sustainable economic growth, jobs, competitiveness and the well-being of Europe's citizens, there is the need to further strengthen Europe's capacity to innovate by: strengthening existing and fostering the creation of new environments conducive to collaboration and innovation; strengthening the innovation capabilities of academia and the research sector; supporting a new generation of entrepreneurial people; stimulating the creation and the development of innovative ventures, as well as strengthening the visibility and recognition of Union funded R&I activities, in particular the EIT funding to the wider public. The nature and scale of the innovation challenges require liaising and mobilising players and resources at European scale, by fostering cross-border collaboration. There is a need to break down silos between disciplines and along value chains and nurture the establishment of a favourable environment for an effective exchange of knowledge and expertise, and for the development and attraction of entrepreneurial talents. The Strategic Innovation Agenda of the EIT shall ensure coherence with the challenges of the Programme, as well as complementarity to the EIC. (2) Areas of Intervention 2.1. Sustainable innovation ecosystems across Europe In accordance with the EIT Regulation and the Strategic Innovation Agenda of the EIT, the EIT plays a reinforced role in strengthening sustainable challenges-based innovation ecosystems throughout Europe. In particular, the EIT continues to operate primarily through its KICs, the large-scale European Partnerships that address specific societal challenges. It continues to strengthen innovation ecosystems around them, by opening them up and by fostering the integration of research, innovation and education. Furthermore, the EIT strengthens innovation ecosystems throughout Europe by expanding its Regional Innovation Scheme (RIS). The EIT works with innovation ecosystems that exhibit high innovation potential based on strategy, thematic alignment and envisaged impact, in close synergy with smart specialisation strategies and Platforms. Broad lines (a) reinforcing the effectiveness and the openness to new partners of the existing KICs, enabling the transition to self-sustainability in the long-term and analysing the need of setting up new ones to tackle global challenges. The specific thematic areas are defined in the Strategic Innovation Agenda of the EIT, taking into account the strategic planning; (b) accelerating regions towards excellence in countries that are referred to in the Strategic Innovation Agenda of the EIT in close cooperation with structural funds and other relevant Union programmes where appropriate. 2.2. Innovation and entrepreneurial skills in a lifelong learning perspective, including increasing capacities of higher education institutions across Europe The EIT education activities are reinforced to foster innovation and entrepreneurship through purposeful education and training. A stronger focus on human capital development is based on the expansion of the EIT's KICs existing education programmes in the view of continuing to offer students and professionals high quality curricula based on innovation, creativity and entrepreneurship in line in particular with the Union's industrial and skills strategy. This may include researchers and innovators supported by other parts of the Programme, in particular MSCA. The EIT also supports the modernisation of higher education institutions across Europe and their integration in innovation ecosystems by stimulating and increasing their entrepreneurial potential and capabilities and encouraging them to better anticipate new skills requirements. Broad lines (a) development of innovative curricula, taking into account the future needs of society and industry, and cross-cutting programmes to be offered to students, entrepreneurs and professionals across Europe and beyond where specialist and sector specific knowledge is combined with innovation-oriented and entrepreneurial skills, such as high-tech skills related to digital and sustainable key enabling technologies; (b) strengthening and expanding the EIT label in order to improve the visibility and the recognition of EIT education programmes based on partnerships between different higher education institutions, research centres and companies while enhancing its overall quality by offering learning-by-doing curricula and purposeful entrepreneurship education as well as international, inter-organisational and cross-sectorial mobility; (c) development of innovation and entrepreneurship capabilities of the higher education sector, by leveraging and promoting the EIT community expertise in linking education, research and business; (d) reinforcing the role of the EIT Alumni community as role model for new students and strong instrument to communicate EIT impact. 2.3. New solutions to the market to address global challenges The EIT facilitates, empowers and awards entrepreneurs, innovators, researchers, educators, students and other innovation actors, while ensuring gender mainstreaming, to work together in cross-disciplinary teams to generate ideas and transform them into both incremental and disruptive innovations. Activities are characterised by an open innovation and cross-border approach, with a focus on including relevant Knowledge Triangle activities that are pertinent to making them a success (such as project's promoters can improve their access to specifically qualified graduates, lead users, start-ups with innovative ideas, non-domestic firms with relevant complementary assets etc.). Broad lines (a) support the development of new products, services and market opportunities where Knowledge Triangle actors collaborate to bring solutions to global challenges; (b) fully integrate the entire innovation value chain: from student to entrepreneur, from idea to product, from lab to customer. This includes support for start-ups and scaling-up businesses; (c) provision of high-level services and support to innovative businesses, including technical assistance to fine-tuning of products or services, substantive mentoring, support to secure target customers and raise capital, in order to swiftly reach the market and speed up their growth process. 2.4. Synergies and value added within the Programme The EIT steps up its efforts to capitalise on synergies and complementarities between existing KICs and with different actors and initiatives at Union and global levels and extend its network of collaborating organisations at both strategic and operational levels, while avoiding duplications. Broad lines (a) close cooperation with the EIC and the InvestEU Programme in streamlining the support (namely funding and services) offered to innovative ventures in both start-up and scale-up stages, in particular through KICs; (b) planning and implementation of EIT activities in order to maximise synergies and complementarities with other parts of the Programme; (c) engage with Member States, at both national and regional level, establishing a structured dialogue and coordinating efforts to enable synergies with national and regional initiatives, including smart specialisation strategies, also considering through the implementation of the 'European innovation ecosystems', in order to identify, share and disseminate best practices and learnings; (d) share and disseminate innovative practices and learnings throughout Europe and beyond, so as to contribute to innovation policy in Europe in coordination with other parts of the Programme; (e) provision of input to innovation policy discussions and contribution to the design and implementation of Union policy priorities by continuously working with all relevant Commission services, other Union programmes and their stakeholders, and further exploring opportunities within policy implementing initiatives; (f) exploitation of synergies with other Union programmes, including those supporting human capital development and innovation (such as COST, ESF+, ERDF, Erasmus+, Creative Europe and COSME Plus/Single Market, the InvestEU Programme); (g) building strategic alliances with key innovation actors at Union and international level, and support to KICs to develop collaboration and linkages with key Knowledge Triangle partners from third countries, with the aim of opening new markets for KICs'-backed solutions and attract financing and talents from abroad. Participation of third countries shall be promoted with regard to the principles of reciprocity and mutual benefits. ANNEX III EUROPEAN PARTNERSHIPS European Partnerships shall be selected and implemented, monitored, evaluated, phased-out or renewed on the basis of the following criteria: 1. Selection Demonstrating that the European Partnership is more effective in achieving the related objectives of the Programme through involvement and commitment of partners, in particular in delivering clear impacts for the Union and its citizens, in particular in view of delivering on global challenges and R&I objectives, securing Union competitiveness, sustainability and contributing to the strengthening of the ERA and, where relevant, international commitments. In the case of Institutionalised European Partnerships established in accordance with Article 185 TFEU, the participation of at least 40 % of the Member States is mandatory: (a) coherence and synergies of the European Partnership within the Union R&I landscape, following the Programme's rules to the largest extent possible; (b) transparency and openness of the European Partnership as regards the identification of priorities and objectives in terms of expected results and impacts and as regards the involvement of partners and stakeholders from across the entire value chain, from different sectors, backgrounds and disciplines, including international ones when relevant and not interfering with European competitiveness; clear arrangements for promoting participation of SMEs and for disseminating and exploiting results, in particular by SMEs, including through intermediary organisations; (c) ex ante demonstration of additionality and directionality of the European Partnership, including a common strategic vision of the purpose of the European Partnership. That vision includes in particular: (i) identification of measurable expected outcomes, results and impacts within specific timeframes, including key economic and/or societal value for the Union; (ii) demonstration of expected qualitative and significant quantitative leverage effects, including a method for the measurement of key performance indicators; (iii) approaches to ensure flexibility of implementation and to adjust to changing policy, societal and/or market needs, or scientific advances, to increase policy coherence between regional, national and Union level; (iv) exit-strategies and measures for phasing-out from the Programme; (d) ex ante demonstration of the partners' long-term commitment, including a minimum share of public and/or private investments. In the case of Institutionalised European Partnerships, established in accordance with Article 185 or 187 TFEU, the financial and/or in-kind contributions from partners other than the Union, is at least equal to 50 % and may reach up to 75 % of the aggregated European Partnership budgetary commitments. For each such Institutionalised European Partnership, a share of the contributions from partners other than the Union will be in the form of financial contributions. For partners other than the Union and participating states, financial contributions should be aimed primarily at covering administrative costs as well as coordination and support and other non-competitive activities. 2. Implementation: (a) systemic approach ensuring active and early involvement of Member States and achievement of the expected impacts of the European Partnership through the flexible implementation of joint actions of high Union added value also going beyond joint calls for proposals for R&I activities, including those related to market, regulatory or policy uptake; (b) appropriate measures ensuring continuous openness of the initiative and transparency during implementation, in particular for priority setting and for participation in calls for proposals, information on the functioning of the governance, visibility of the Union, communication and outreach measures, dissemination and exploitation of results, including clear open access/user strategy along the value chain; appropriate measures for informing SMEs and promoting their participation; (c) coordination or joint activities with other relevant R&I initiatives to secure optimum level of interconnections and ensure effective synergies, among other things, to overcome potential implementation barriers at national level and increase cost-effectiveness; (d) commitments, for financial and/or in-kind contributions, from each partner in accordance with national provisions throughout the duration of the initiative; (e) in the case of Institutionalised European Partnership access to the results and other action related information for the Commission for the purpose of developing, implementing and monitoring of Union policies or programmes. 3. Monitoring: (a) a monitoring system in accordance with Article 50 to track progress towards specific policy objectives, deliverables and key performance indicators allowing for an assessment over time of achievements, impacts and potential needs for corrective measures; (b) periodic dedicated reporting on quantitative and qualitative leverage effects, including on committed and actually provided financial and in-kind contributions, visibility and positioning in the international context, impact on R&I related risks of private sector investments; (c) detailed information on the evaluation process and results from all calls for proposals within European Partnerships, to be made available timely and accessible in a common e-database. 4. Evaluation, phasing-out and renewal: (a) evaluation of impacts achieved at Union and national level in relation to defined targets and key performance indicators, feeding into the Programme evaluation set out in Article 52, including an assessment of the most effective policy intervention mode for any future action; and the positioning of any possible renewal of a European Partnership in the overall European Partnerships landscape and its policy priorities; (b) in the absence of renewal, appropriate measures ensuring phasing-out of the Programme funding according to the conditions and timeline agreed with the legally committed partners ex ante, without prejudice to possible continued transnational funding by national or other Union programmes, and without prejudice to private investment and on-going projects. ANNEX IV SYNERGIES WITH OTHER UNION PROGRAMMES Synergies with other Union programmes are based on complementarity between programme design and objectives and on compatibility of financing rules and processes at implementation level. Funding from the Programme shall be used only to finance R&I activities. The strategic planning shall ensure the alignment of priorities for the different Union programmes and ensure coherent funding options at different stages of the R&I cycle. Missions and European Partnerships shall, among other things, benefit from synergies with other Union programmes and policies. The deployment of research results and innovative solutions developed in the Programme shall be facilitated with the support of other Union programmes, in particular through dissemination and exploitation strategies, transfer of knowledge, complementary and cumulative funding sources and accompanying policy measures. Funding for R&I activities shall profit from harmonised rules that are designed to ensure Union added value, to avoid overlaps with different Union programmes and to seek maximum efficiency and administrative simplification. More detail as to how the synergies shall apply between the Programme and the different Union programmes is set out in the following paragraphs: 1. Synergies with the European Agricultural Guarantee Fund (EAGF) and the European Agricultural Fund for Rural Development (EAFRD) under the Common Agricultural Policy (CAP) shall ensure that: (a) the R&I needs of the agricultural sector and of rural areas within the Union are identified, for example, within the European Innovation Partnership 'Agricultural Productivity and Sustainability' and taken into consideration in both the Programme's strategic planning and the work programmes; (b) the CAP makes the best use of R&I results and promotes the use, implementation and deployment of innovative solutions, including those stemming from projects funded by the framework programmes for R&I, from the European Innovation Partnership 'Agricultural Productivity and Sustainability' and relevant KICs of the EIT; (c) the EAFRD supports the uptake and dissemination of knowledge and solutions stemming from the Programme's results leading to a more dynamic farming sector and new openings for the development of rural areas. 2. Synergies with the European Maritime, Fisheries and Aquaculture Fund (EMFAF) shall ensure that: (a) the Programme and the EMFAF are closely interlinked, since Union R&I needs in the field of marine and integrated maritime policy are translated through the Programme's strategic planning; (b) the EMFAF supports the rolling out of novel technologies and innovative products, processes and services, in particular those resulting from the Programme in the fields of marine and integrated maritime policy; the EMFAF also promotes ground data collection, processing and monitoring, and disseminates relevant actions supported under the Programme, which in turn contributes to the implementation of the Common Fisheries Policy, the EU Integrated Maritime Policy, International Ocean Governance and international commitments. 3. Synergies with the European Regional Development Fund (ERDF) shall ensure that: (a) with the aim of strengthening the ERA and of contributing to the SDGs, arrangements for alternative and cumulative funding from ERDF and the Programme support activities that provide a bridge, in particular, between smart specialisation strategies and excellence in R&I, including joint trans-regional/trans-national programmes and pan European Research Infrastructures; (b) the ERDF focuses, among other things, on the development and strengthening of regional and local R&I ecosystems, networks and industrial transformation, including support to building R&I capacities, to the take-up of results and to the rolling out of novel technologies and innovative and climate-friendly solutions from the framework programmes for R&I through the ERDF. 4. Synergies with the European Social Fund Plus (ESF+) shall ensure that: (a) through national or regional programmes, the ESF+ can mainstream and scale up innovative curricula supported by the Programme, in order to equip people with the skills and competences needed for evolving demands of the labour market; (b) arrangements for alternative and combined funding from ESF+ can be used to support activities of the Programme that promote human capital development in R&I with the aim of strengthening the ERA; (c) the ESF+ mainstreams innovative technologies and new business models and solutions, in particular those resulting from the Programme, so as to contribute to innovative, efficient and sustainable health systems and facilitate access to better and safer healthcare for European citizens. 5. Synergies with the EU4Health Programme shall ensure that: (a) Union R&I needs in the field of health are identified and established through the Programme's strategic planning; (b) the EU4Health Programme contributes to ensuring best use of research results, in particular those resulting from the Programme. 6. Synergies with the Connecting Europe Facility (CEF) shall ensure that: (a) the R&I needs in the areas of transport, energy and in the digital sector within the Union are identified and established through the Programme's strategic planning; (b) the CEF supports the large-scale roll-out and deployment of innovative new technologies and solutions in the fields of transport, energy and digital physical infrastructures, in particular those resulting from the framework programmes for R&I; (c) the exchange of information and data between the Programme and CEF projects are facilitated, for example by highlighting technologies from the Programme with a high market readiness that could be further deployed through the CEF. 7. Synergies with the Digital Europe Programme (DEP) shall ensure that: (a) whereas several thematic areas addressed by the Programme and DEP converge, the type of actions to be supported, their expected results and their intervention logic are different and complementary; (b) the R&I needs related to digital aspects of the Programme are identified and established through its strategic planning; this includes, for example, R&I for high performance computing, artificial intelligence, cybersecurity, distributed ledger technologies, quantum technologies combining digital with other enabling technologies and non-technological innovations; support for the scale-up of companies introducing breakthrough innovations (many of which combine digital and physical technologies); and support to digital research infrastructures; (c) DEP focuses on large-scale digital capacity and infrastructure building in, for example, high performance computing, artificial intelligence, cybersecurity, distributed ledger technologies, quantum technologies and advanced digital skills aiming at wide uptake and deployment across the Union of critical existing or tested innovative digital solutions within a Union framework in areas of public interest (such as health, public administration, justice and education) or market failure (such as the digitisation of businesses, in particular SMEs); DEP is mainly implemented through coordinated and strategic investments with Member States, in particular through joint public procurement, in digital capacities to be shared across the Union and in Union-wide actions that support interoperability and standardisation as part of developing the Digital Single Market; (d) DEP capacities and infrastructures are made available to the R&I community, including for activities supported under the Programme including testing, experimentation and demonstration across all sectors and disciplines; (e) novel digital technologies developed through the Programme are to be progressively taken up and deployed by DEP; (f) the Programme's initiatives for the development of skills and competencies curricula, including those delivered at the relevant EIT KICs, are complemented by DEP supported capacity-building in advanced digital skills; (g) strong coordination mechanisms for strategic programming, operating procedures and governance structures exist for both programmes. 8. Synergies with the Single Market Programme shall ensure that: (a) the Single Market Programme addresses the market failures which affect SMEs and promotes entrepreneurship and the creation and growth of companies, and complementarity exists between the Single Market Programme and the actions of both the EIT and the EIC for innovative companies, as well as in the area of support services for SMEs, in particular where the market does not provide viable financing; (b) the Enterprise Europe Network may serve, in addition to other existing SME support structures (e.g. National Contact Points, Innovation Agencies, Digital Innovation Hubs, Competence Centres, incubators), to deliver support services under the Programme, including the EIC. 9. Synergies with the LIFE - Programme for Environment and Climate Action (LIFE) shall ensure that: (a) the R&I needs to tackle environmental, climate and energy challenges within the Union are identified and established through the Programme's strategic planning; (b) LIFE continues to act as a catalyst for implementing the Union's environment, climate and relevant energy policy and legislation, including by taking up and applying R&I results from the Programme and help deploying them at national, interregional and regional scale where it can help address environmental, climate or clean energy transition issues. In particular LIFE continues to incentivise synergies with the Programme through the award of a bonus during the evaluation for proposals which feature the uptake of results from the Programme; (c) LIFE standard action projects support the development, testing or demonstration of suitable technologies or methodologies for the implementation of the Union's environment and climate policy, which can subsequently be deployed on a large scale, funded by other sources, including by the Programme. The EIT as well as the EIC can provide support to scale up and commercialise new breakthrough ideas that may result from the implementation of LIFE projects. 10. Synergies with Erasmus+ shall ensure that: (a) combined resources from the Programme, including from the EIT, and Erasmus+ are used to support activities dedicated to strengthening, modernising and transforming European higher education institutions. Where appropriate, the Programme complements the Erasmus+'s support for the European Universities Initiative in its research dimension, as part of the development of new joint and integrated long-term and sustainable strategies on education, R&I based on trans-disciplinary and cross-sectoral approaches to make the knowledge triangle a reality. The EIT's activities could complement the strategies to be implemented by the European Universities Initiative; (b) the Programme and Erasmus+ foster the integration of education and research through assisting higher education institutions to formulate and set up common education, R&I strategies and networks, through informing education systems, teachers and trainers of the latest findings and practices in research and in offering active research experience to all students and higher education staff and in particular researchers, and to support other activities that integrate higher education and R&I. 11. Synergies with the Union Space Programme shall ensure that: (a) the R&I needs of the Union Space Programme and those of the space upstream and downstream sector within the Union are identified and established as part of the Programme's strategic planning; space research actions implemented through the Programme are implemented with regard to procurement and eligibility of legal entities in accordance with the Union Space Programme, where appropriate; (b) space data and services made available as a public good by the Union Space Programme are used to develop breakthrough solutions through R&I, including in the Programme, in particular for sustainable food and natural resources, climate monitoring, atmosphere, land, coastal and marine environment, smart cities, connected and automated mobility, security and disaster management; (c) the Copernicus Data and Information Access Services contribute to the EOSC and thus facilitate access to Copernicus data for researchers, scientists and innovators; research infrastructures, in particular in situ observing networks constitute essential elements of the in situ observation infrastructure enabling the Copernicus services, and in turn, they benefit from information produced by Copernicus services. 12. Synergies with the Neighbourhood, Development and International Cooperation Instrument (NDICI) and the Instrument for Pre-accession Assistance (IPA III) shall ensure that: (a) the R&I needs in the areas of NDICI and IPA III are identified through the Programme's strategic planning, in line with the SDGs; (b) the Programme's R&I activities, with the participation of third countries and targeted international cooperation actions, seek alignment and coherence with parallel market uptake and capacity-building actions strands under the NDICI and IPA III, based on joint definition of needs and of areas of intervention. 13. Synergies with the Internal Security Fund and the instrument for border management as part of the Integrated Border Management Fund shall ensure that: (a) the R&I needs in the areas of security and integrated border management are identified and established through the Programme's strategic planning; (b) the Internal Security Fund and the Integrated Border Management Fund support the deployment of innovative new technologies and solutions, in particular those resulting from the framework programmes for R&I in the field of security research. 14. Synergies with the InvestEU Programme shall ensure that: (a) the Programme provides Horizon Europe blended finance and EIC blended finance for innovators, characterised by a high level of risk and for which the market does not provide sufficient and viable financing; at the same time, the Programme supports the effective delivery and management of the private part of blended finance through funds and intermediaries supported by the InvestEU Programme and others; (b) financial instruments for R&I and SMEs are grouped together under the InvestEU Programme, in particular through a dedicated R&I thematic window, and through products deployed under the SME window, thereby helping to deliver the objectives of both programmes as well as establishing strong complementary links between both programmes; (c) the Programme provides appropriate support to help the reorientation of bankable projects, not suitable for EIC funding, towards the InvestEU Programme, where relevant. 15. Synergies with the Innovation Fund under the Emission Trading Scheme (the 'Innovation Fund') shall ensure that: (a) the Innovation Fund specifically targets innovation in low-carbon technologies and processes, including environmentally safe carbon capture and utilisation that contributes substantially to mitigate climate change, as well as products substituting carbon intensive ones, and to help stimulate the construction and operation of projects that aim towards the environmentally safe capture and geological storage of CO2 as well as innovative renewable energy and energy storage technologies, and to enable and to incentivise 'greener' products; (b) the Programme funds the development and demonstration of technologies, including breakthrough solutions, that can deliver on the Union's climate neutrality, energy and industrial transformation objectives, especially through its Pillar II and Pillar III activities; (c) the Innovation Fund may, subject to fulfilment of its selection and award criteria, support the demonstration phase of eligible projects that may have received the support from the Programme and strong complementary links shall be established between both programmes. 16. Synergies with the Just Transition Mechanism shall ensure that: (a) R&I needs are identified through the Programme's strategic planning to support a just and fair transition towards climate-neutrality; (b) the take-up and deployment of innovative and climate-friendly solutions, in particular those resulting from the Programme, are promoted. 17. Synergies with the Euratom Research and Training Programme shall ensure that: (a) the Programme and the Euratom Research and Training Programme develop comprehensive actions supporting education and training (including MSCA) with the aim of maintaining and developing relevant skills in Europe; (b) the Programme and the Euratom Research and Training Programme develop joint research actions focussing on cross-cutting aspects of the safe and secure use of non-power applications of ionising radiation in sectors such as medicine, industry, agriculture, space, climate change, security and emergency preparedness and contribution of nuclear science. 18. Potential synergies with the European Defence Fund shall benefit civil and defence research with a view to avoiding unnecessary duplication and in accordance with Article 5 and Article 7(1). 19. Synergies with the Creative Europe Programme shall be fostered by identifying R&I needs in the field of cultural and creative policies in the Programme's strategic planning. 20. Synergies with the Recovery and Resilience Facility shall ensure that: (a) R&I needs to support making Member States economies and society more resilient and better prepared for the future are identified through the Programme's strategic planning; (b) the take-up and deployment of innovative solutions, in particular those resulting from the Programme, are supported. ANNEX V KEY IMPACT PATHWAY INDICATORS Impact pathways, and related key impact pathway indicators, shall structure the monitoring of the Programme's progress towards its objectives as referred to in Article 3. The impact pathways shall be time-sensitive and reflect three complementary impact categories reflecting the non-linear nature of R&I investments: scientific, societal and technological or economic. For each of those impact categories, proxy indicators are used to track progress distinguishing between the short, medium and longer terms, including beyond the Programme's duration, with possibilities for breakdowns, including by Member States and associated countries. Those indicators shall be compiled using quantitative and qualitative methodologies. Individual Programme parts contribute to those indicators to a different degree and through different mechanisms. Additional indicators can be used to monitor individual Programme parts, where relevant. The micro-data behind the key impact pathway indicators are collected for all parts of the Programme and for all delivery mechanisms in a centrally managed and harmonised way and at the appropriate level of granularity with minimal reporting burden on the beneficiaries. In addition and beyond key impact pathways indicators, data on the optimised delivery of the Programme for strengthening the ERA, fostering the excellence-based participations from all Member States in the Programme as well as facilitating collaborative links in European R&I are collected and reported in close to real-time as part of implementation and management data, referred to in Article 50. This includes the monitoring of collaborative links, of network analytics, of data on proposals, applications, participations, projects, applicants and participants (including data on the type of organisation, such as civil society organisations, SMEs and private sector), country (such as a specific classification for country groups such as Member States, associated countries and third countries), gender, role in project, scientific discipline or sector, including SSH), and the monitoring of the level of climate mainstreaming and related expenditures. Scientific impact pathway indicators The Programme is expected to have scientific impact by creating high-quality new knowledge, strengthening human capital in R&I, and fostering diffusion of knowledge and open science. Progress towards this impact is monitored through proxy indicators set along the following three key impact pathways. Table 1 Towards scientific impact Short-term Medium-term Longer-term Creating high-quality new knowledge Publications - Number of peer-reviewed scientific publications resulting from the Programme Citations - Field-Weighted Citation Index of peer-reviewed Publications resulting from the Programme World-class science - Number and share of peer-reviewed publications resulting from the projects funded by the Programme that are core contribution to scientific fields Strengthening human capital in R&I Skills - Number of researchers involved in upskilling (training, mentoring/coaching, mobility and access to R&I infrastructures) activities in projects funded by the Programme Careers - Number and share of upskilled researchers involved in the Programme with increased individual impact in their R&I field Working conditions - Number and share of upskilled researchers involved in the Programme with improved working conditions, including researchers' salaries Fostering diffusion of knowledge and open science Shared knowledge - Share of research outputs (open data/publication/software etc.) resulting from the Programme shared through open knowledge infrastructures Knowledge diffusion - Share of open access research outputs resulting from the Programme actively used/cited New collaborations - Share of Programme beneficiaries which have developed new transdisciplinary/transsectoral collaborations with users of their open access research outputs resulting from the Programme Societal impact pathway indicators The Programme is expected to have societal impact by addressing the Union's policy priorities and global challenges, including SDGs, following the principles of the 2030 Agenda and the goals of the Paris Agreement, through R&I, delivering benefits and impact through R&I missions and European Partnerships and strengthening the uptake of innovation in society ultimately contributing to people's well-being. Progress towards this impact is monitored through proxy indicators set along the following three key impact pathways. Table 2 Towards societal impact Short-term Medium-term Longer-term Addressing Union policy priorities and global challenges through R&I Results - Number and share of results aimed at addressing identified Union policy priorities and global challenges (including SDGs) (multidimensional: for each identified priority) Including: Number and share of climate-relevant results aimed at delivering on the Union's commitment under the Paris Agreement Solutions - Number and share of innovations and research outcomes addressing identified Union policy priorities and global challenges (including SDGs) (multidimensional: for each identified priority) Including: Number and share of climate-relevant innovations and research outcomes delivering on Union's commitment under the Paris Agreement Benefits - Aggregated estimated effects from use/exploitation of results funded by the Programme on tackling identified Union policy priorities and global challenges (including SDGs), including contribution to the policy and law-making cycle (such as norms and standards) (multidimensional: for each identified priority) Including: Aggregated estimated effects from use/exploitation of climate-relevant results funded by the Programme on delivering on the Union's commitment under the Paris Agreement including contribution to the policy and law-making cycle (such as norms and standards) Delivering benefits and impact through R&I missions R&I mission results - Results in specific R&I missions (multidimensional: for each identified mission) R&I mission outcomes - Outcomes in specific R&I missions (multidimensional: for each identified mission) R&I mission targets met - Targets achieved in specific R&I missions (multidimensional: for each identified mission) Strengthening the uptake of R&I in society Co-creation - Number and share of projects funded by the Programme where Union citizens and end-users contribute to the co-creation of R&I content Engagement - Number and share of participating legal entities which have citizen and end-users engagement mechanisms in place after the end of projects funded by the Programme Societal R&I uptake - Uptake and outreach of co-created scientific results and innovative solutions generated under the Programme Technological and Economic impact pathway indicators The Programme is expected to have technological and economic impact especially within the Union by influencing the creation and growth of companies, especially SMEs including start-ups, creating direct and indirect jobs especially within the Union, and by leveraging investments for R&I. Progress towards this impact is monitored through proxy indicators set along the following three key impact pathways. Table 3 Towards technological / economic impact Short-term Medium-term Longer-term Generating innovation-based growth Innovative results - Number of innovative products, processes or methods resulting from the Programme (by type of innovation) & Intellectual Property Rights (IPR) applications Innovations - Number of innovations resulting from the projects funded by the Programme (by type of innovation) including from awarded IPRs Economic growth - Creation, growth & market shares of companies having developed innovations in the Programme Creating more and better jobs Supported employment - Number of full time equivalent (FTE) jobs created, and jobs maintained in participating legal entities for the project funded by the Programme (by type of job) Sustained employment - Increase of FTE jobs in participating legal entities following the project funded by the Programme (by type of job) Total employment - Number of direct & indirect jobs created or maintained due to diffusion of results from the Programme (by type of job) Leveraging investments in R&I Co-investment - Amount of public & private investment mobilised with the initial investment from the Programme Scaling-up - Amount of public & private investment mobilised to exploit or scale-up results from the Programme (including foreign direct investments) Contribution to '3 % target' - Union progress towards 3 % GDP target due to the Programme ANNEX VI AREAS FOR POSSIBLE MISSIONS AND AREAS FOR POSSIBLE INSTITUTIONALISED EUROPEAN PARTNERSHIPS TO BE ESTABLISHED UNDER ARTICLE 185 OR 187 TFEU In accordance with Articles 8 and 12 of this Regulation, the areas for possible missions and possible European Partnerships to be established under Article 185 or 187 TFEU are set out in this Annex. I. Areas for possible missions: \u2014 Missions Area 1: Adaptation to Climate Change, including Societal Transformation. \u2014 Mission Area 2: Cancer. \u2014 Mission Area 3: Healthy Oceans, Seas, Coastal and Inland Waters. \u2014 Mission Area 4: Climate-Neutral and Smart Cities. \u2014 Mission Area 5: Soil Health and Food. Each mission follows the principles set out in Article 8(4) of this Regulation. II. Areas for possible Institutionalised European Partnerships on the basis of Article 185 or 187 TFEU: \u2014 Partnership Area 1: Faster development and safer use of health innovations for European patients, and global health. \u2014 Partnership Area 2: Advancing key digital and enabling technologies and their use, including but not limited to novel technologies such as artificial intelligence, photonics and quantum technologies. \u2014 Partnership Area 3: European leadership in Metrology including an integrated Metrology system. \u2014 Partnership Area 4: Accelerate competitiveness, safety and environmental performance of Union air traffic, aviation and rail. \u2014 Partnership Area 5: Sustainable, inclusive and circular bio-based solutions. \u2014 Partnership Area 6: Hydrogen and sustainable energy storage technologies with lower environmental footprint and less energy-intensive production. \u2014 Partnership Area 7: Clean, connected, cooperative, autonomous and automated solutions for future mobility demands of people and goods. \u2014 Partnership Area 8: Innovative and R&D intensive SMEs. The process of assessing the need for an Institutionalised European Partnership in one of the abovementioned Partnership Areas may result in a legislative proposal in accordance with the Commission's right of initiative. Otherwise the respective Partnership Area can also be subject to a European Partnership following point (a) of Article 10(1) or point (b) of Article 10(1) of this Regulation or be implemented by other calls for proposals within this Programme. As the possible areas for Institutionalised European Partnerships cover broad thematic fields, they can, based on the assessed needs, be implemented by more than one European Partnership.", "summary": "Horizon Europe \u2014 the framework programme for research and innovation, laying down its rules for participation and dissemination Horizon Europe \u2014 the framework programme for research and innovation, laying down its rules for participation and dissemination SUMMARY OF: Regulation (EU) 2021/695 establishing Horizon Europe \u2014 the framework programme for research and innovation, laying down its rules for participation and dissemination WHAT IS THE AIM OF THE REGULATION? It establishes Horizon Europe \u2014 the framework programme for research and innovation (the \u2018programme\u2019) for the duration of the 2021-2027 multiannual financial framework , and lays down its rules for participation and dissemination.The regulation: determines the framework governing European Union (EU) support for research and innovation (R & I) in terms of the scientific and technological objectives to be achieved and the relevant priorities, indicates the broad lines of such activities and fixes the maximum overall amount and the detailed rules for EU financial participation in the framework programme and the respective shares in each of the activities provided for; sets out rules for the participation of undertakings, research centres and universities and lays down the rules governing the dissemination of research results. KEY POINTS Implementation The programme is implemented through: the specific programme established by Decision (EU) 2021/764 (see summary); a financial contribution to the European Institute of Innovation and Technology (EIT) established by Regulation (EU) 2021/819; the specific programme on defence research established by Regulation (EU) 2021/697 (see summary). Objectives The general objective of the programme is to deliver scientific, technological, economic and societal impact from the EU\u2019s investments in R & I so as to: strengthen the EU\u2019s scientific and technological bases and foster competitiveness in all EU Member States, including in its industry; deliver on the EU\u2019s strategic priorities and contribute to the fulfilment of its objectives and policies; tackle global challenges, including meeting the UN sustainable development goals (SDGs) by following the principles of the 2030 Agenda and the Paris Agreement; strengthen the European research area (ERA). The programme thus maximises EU added value by focusing on objectives and activities that cannot be effectively fulfilled by Member States acting alone, but rather in cooperation. The programme has the following specific objectives: to develop, promote and advance scientific excellence, support the creation and diffusion of high-quality new fundamental and applied knowledge of skills, technologies and solutions, support training and mobility of researchers, attract talent at all levels and contribute to the full engagement of the EU\u2019s talent pool in actions supported under the programme; to generate knowledge, strengthen the impact of R & I in developing, supporting and implementing EU policies and support access to and the uptake of innovative solutions in European industry, in particular in small and medium-sized enterprises, and address global societal challenges, including climate change and the sustainable development goals; to foster all forms of innovation, facilitate technological development, demonstration and knowledge and technology transfer, and strengthen the deployment and exploitation of innovative solutions; to optimise the programme\u2019s delivery with a view to strengthening and increasing the impact and attractiveness of the European research area, foster excellence-based participation from all Member States, including low-R & I-performing countries, in the programme and facilitate collaborative links in European R & I. Structure and budget The programme is structured as follows, with a total budget of \u20ac95.5 billion at current prices (including \u20ac5.4 billion from NextGenerationEU). Pillar I \u2014 Excellent science With these components: European Research Council Marie Sk\u0142odowska-Curie actions research infrastructures. Pillar II \u2014 Global challenges and European industrial competitiveness With these components: \u2018Health\u2019 cluster; \u2018Culture, creativity and inclusive society\u2019 cluster; \u2018Civil security for society\u2019 cluster; \u2018Digital, industry and space\u2019 cluster; \u2018Climate, energy and mobility\u2019 cluster; \u2018Food, bioeconomy, natural resources, agriculture and environment\u2019 cluster; non-nuclear direct actions undertaken by the European Commission\u2019s Joint Research Centre. Pillar III \u2014 Innovative Europe With these components: European Innovation Council (EIC) European innovation ecosystems (EIE) European Institute of Innovation and Technology (EIT). Part \u2014 Widening participation and strengthening the European research area With these components: widening participation and spreading excellence; reforming and enhancing the European R & I system. Missions Missions are portfolios of excellence-based and impact-driven R & I activities across disciplines and sectors, intended to: achieve, within a set time frame, a measurable goal that could not be achieved through individual actions; have an impact on society and policymaking through science and technology; be relevant for a significant part of the EU population and a wide range of EU citizens. Five areas for possible missions are identified in this legal act: adaptation to climate change, including societal transformation cancer healthy oceans, seas and coastal and inland waters climate-neutral and smart cities soil health and food. Each mission area has a dedicated mission board, which advises the Commission in specifying, designing and implementing specific missions. European partnerships A streamlined landscape of three forms of European partnerships (co-funded, co-programmed and institutionalised) has been created in which the EU, national authorities and the private sector commit to supporting research and innovation efforts. The European Innovation Council The EIC has been created as a centrally managed one-stop shop for implementing actions under Pillar III \u2018Innovative Europe\u2019 which relate to the EIC. The EIC\u2019s focus is mainly on breakthrough and disruptive innovation, especially targeting market-creating innovation, while also supporting all types of innovation, including incremental innovation. Involvement of non-EU countries Horizon Europe is open to the participation of legal entities from anywhere in the world, under the conditions set out in the rules, and where applicable together with any additional condition at work programme / call level. Participation in the programme in the form of association of non-EU countries is open to: European Economic Area (EEA) and European Free Trade Association (EFTA) countries; acceding countries, candidate countries and potential candidates; European neighbourhood policy countries; non-EU countries with a good capacity in science, technology and innovation and commitment to a rules-based open market economy. Rules for participation The regulation sets out different rules, such as for eligibility for participation and funding, ethical rules and principles, and security that are applicable to indirect actions funded under the programme. Examples of these include: any legal entity may participate and receive funding if it meets the eligibility conditions under the Horizon Europe rules, together with any other additional conditions in the work programme / call; the content of calls for proposals must be included in the work programme; the Commission or the funding body may issue a joint call for proposals with non-EU countries, including their scientific and technological organisations or agencies, international organisations and non-profit legal entities; procurement procedures must comply with competition rules and the principles of transparency, non-discrimination, equal treatment, sound financial management and proportionality; rules regarding financial capacity checks; the process to evaluate proposals, including the selection and award criteria \u2014 proposals are evaluated by an independent expert committee, based on excellence, impact, quality and efficiency of implementation; applicants may request an evaluation review if they consider that the evaluation procedure has not been correctly applied; obligations with respect to exploiting and disseminating the results, including regarding open science. Programme evaluation, impact assessment and monitoring The Commission evaluates and monitors Horizon Europe to assess progress in achieving the programme\u2019s objectives. The programme is complemented by the research and training programme of the European Atomic Energy Community for 2021-2025. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND The regulation repeals Regulation (EU) No 1291/2013 and Regulation (EU) No 1290/2013. See also: Horizon Europe (European Commission) Horizon Europe: The EU research & innovation programme 2021-2027 (European Commission) European research area (ERA) (European Commission) A new ERA for research and innovation (European Commission). MAIN DOCUMENT Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2014 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1-68) RELATED DOCUMENTS Regulation (EU) 2021/819 of the European Parliament and of the Council of 20 May 2021 on the European Institute of Innovation and Technology (recast) (OJ L 189, 28.5.2021, pp. 61-90) Council Decision (EU) 2021/764 of 10 May 2021 establishing the Specific Programme implementing Horizon Europe \u2014 the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (OJ L 167I, 12.5.2021, pp. 1-80) Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 (OJ L 170, 12.5.2021, pp. 149-177) Council Regulation (Euratom) 2021/765 of 10 May 2021 establishing the Research and Training Programme of the European Atomic Energy Community for the period 2021-2025 complementing Horizon Europe \u2014 the Framework Programme for Research and Innovation and repealing Regulation (Euratom) 2018/1563 (OJ L 167I, 12.5.2021, pp. 81-100) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I, 22.12.2020, pp. 23-27) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, pp. 11-22) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222) last update 02.07.2021"}
{"article": "12.5.2021 EN Official Journal of the European Union L 170/69 REGULATION (EU) 2021/696 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 189(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Space technology, data and services have become indispensable in the daily lives of Europeans and play an essential role in preserving many strategic interests. The Union\u2019s space industry is already one of the most competitive in the world. However, the emergence of new players and the development of new technologies are revolutionising traditional industrial models. Therefore, for the Union to remain a leading international player with extensive freedom of action in the space domain, it is crucial that it encourages scientific and technical progress and supports the competitiveness and innovation capacity of space sector industries within the Union, in particular small and medium-sized enterprises (SMEs), start-ups and innovative businesses. (2) The possibilities that space offers for the security of the Union and its Member States should be exploited, as referred to in particular in the Global Strategy for the European Union\u2019s Foreign and Security Policy of June 2016, while retaining the civil nature of the Union Space Programme (\u2018the Programme\u2019) and respecting the possible neutrality or non-alignment provisions stipulated in the constitutional law of Member States. Historically, the space sector\u2019s development has been linked to security. In many cases, the equipment, components and instruments used in the space sector, as well as space data and services, are dual-use. However, the Union\u2019s security and defence policy is determined within the framework of the Common Foreign and Security Policy, in accordance with Title V of the Treaty on European Union (TEU). (3) The Union has been developing its own space initiatives and programmes since the end of the 1990s, namely the European Geostationary Navigation Overlay Service (EGNOS) and then Galileo and Copernicus, which respond to the needs of Union citizens and the requirements of public policies. The continuity of those initiatives and programmes should be ensured and the services they provide should be improved, so that they meet the new needs of users, remain at the forefront in view of new technology development and the transformations in the digital and information and communications technology domains, and are able to meet political priorities such as climate change, including monitoring changes in the polar region, transport, security and defence. (4) It is necessary to exploit synergies between the transport, space and digital sectors in order to foster the broader use of new technologies, such as e-call, digital tachograph, traffic supervision and management, autonomous driving and unmanned vehicles and drones, and to respond to the need of secure and seamless connectivity, robust positioning, inter modality and interoperability. Such exploitation of synergies would enhance the competitiveness of transport services and industry. (5) To reap the maximum benefits of the Programme, in all Member States and by all their citizens, it is also essential to promote the use and the uptake of the data, information and services provided, as well as to support the development of downstream applications based on those data, information and services. To that end, the Member States, the Commission and the entities responsible could, in particular, periodically run information campaigns regarding the benefits of the Programme. (6) To achieve the objectives of freedom of action, independence and security, it is essential that the Union benefits from an autonomous access to space and is able to use it safely. It is therefore essential that the Union supports autonomous, reliable and cost-effective access to space, especially as regards critical infrastructure and technology, public security and the security of the Union and its Member States. The Commission should therefore have the possibility to aggregate launch services at European level, both for its own needs and, at their request, for those of other entities, including Member States, in accordance with Article 189(2) of the Treaty on the Functioning of the European Union (TFEU). To remain competitive in a rapidly evolving market, it is also crucial that the Union continues to have access to modern, efficient and flexible launch infrastructure facilities and benefits from appropriate launch systems. Therefore, without prejudice to measures taken by Member States or the European Space Agency (ESA), it should be possible for the Programme to support adaptations to the space ground infrastructure, including new developments, which are necessary for the implementation of the Programme and adaptations, including technology development, to space launch systems which are necessary for launching satellites, including alternative technologies and innovative systems, for the implementation of the Programme\u2019s components. Those activities should be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (2) (the \u2018Financial Regulation\u2019), and with a view to achieving better cost-efficiency for the Programme. Since there will be no dedicated budget, the actions in support of access to space should be without prejudice to the implementation of the Programme\u2019s components. (7) To strengthen the competitiveness of the Union space industry and increase capacity in designing, building and operating its own systems, the Union should support the creation, growth, and development of the entire space industry. The emergence of a business- and innovation-friendly model should be supported at European, regional and national levels by initiatives such as space hubs that bring together the space, digital and other sectors, as well as users. Those space hubs should aim to foster entrepreneurship and skills while pursuing synergies with the digital innovation hubs. The Union should foster the creation and expansion of Union-based space companies to help them succeed, including by supporting them in accessing risk finance in view of the lack of appropriate access within the Union to private equity for space start-ups and by fostering demand, known as the first contract approach. (8) The space value chain is generally segmented between upstream activities and downstream activities. Upstream activities comprise those leading to an operational space system, including development, manufacturing and launch activities and the operations of such a system. Downstream activities comprise those covering the provision of space-related services, and products to users. Digital platforms are also an important element supporting the development of the space sector. They allow access to data and products as well as toolboxes, storage and computing facilities. (9) In the area of space, the Union exercises its competences in accordance with Article 4(3) TFEU. The Commission should ensure the coherence of activities performed in the context of the Programme. (10) Whilst a number of Member States have a tradition of active space-related industries, the need to develop and mature space industries in Member States with emerging capabilities and the need to respond to the challenges faced by the traditional space industries posed by New Space should be recognised. Actions to develop space industry capacity across the Union and facilitate collaboration across space industry active in all Member States should be promoted. (11) Actions under the Programme should build on and benefit from national and European capacities, which exist at the time the action is being carried out. (12) Owing to the Programme\u2019s coverage and its potential to help resolve global challenges, space activities have a strong international dimension. In close coordination with the Member States, and with their agreement, the relevant bodies of the Programme might participate in matters pertaining to the Programme, in international cooperation and to collaborate in relevant sectoral bodies of the United Nations (UN). For matters relating to the Programme, the Commission might coordinate, on behalf of the Union and in its field of competence, the activities on the international scene, in particular to defend the interests of the Union and its Member States in international fora, including in the area of frequencies as regards the Programme, without prejudice to Member States\u2019 competence in that area. It is particularly important for the Union, represented by the Commission, to collaborate in the bodies of the International Cospas-Sarsat Programme. (13) International cooperation is paramount in promoting the role of the Union as a global actor in the space sector and the Union\u2019s technology and industry, fostering fair competition at international level, bearing in mind the need to ensure the reciprocity of the rights and obligations of the parties, and to encourage cooperation in the field of training. International cooperation is a key element of the Space Strategy for Europe, as set out by the Commission in its Communication of 26 October 2016. The Commission should use the Programme to contribute to and benefit from international efforts through initiatives, to promote European technology and industry internationally, for example bi-lateral dialogues, industry workshops and support for SME internationalisation, and to facilitate access to international markets and foster fair competition, also leveraging economic diplomacy initiatives. European space diplomacy initiatives should be in full coherence and complementarity with the existing Union policies, priorities and instruments, while the Union has a key role to play, together with Member States, in remaining at the forefront of the international scene. (14) Without prejudice to the competence of Member States, the Commission should promote, alongside the High Representative of the Union for Foreign Affairs and Security Policy (\u2018the High Representative\u2019) and in close coordination with Member States, responsible behaviour in space when implementing the Programme including reducing space debris proliferation. The Commission should also explore the possibility of the Union\u2019s acceptance of the rights and obligations provided for in the relevant UN Treaties and Conventions and make, if necessary, appropriate proposals. (15) The Programme shares similar objectives with other Union programmes, particularly Horizon Europe established by Regulation (EU) 2021/695 of the European Parliament and of the Council (3), the InvestEU Programme established by Regulation (EU) 2021/523 of the European Parliament and of the Council (4), the European Defence Fund established by Regulation (EU) 2021/697 of the European Parliament and of the Council (5) and Funds under a Regulation laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the \u2018Common Provisions Regulation\u2019). Therefore, cumulative funding from those programmes should be provided for, provided that they do not cover the same cost items, in particular through arrangements for complementary funding from Union programmes where management modalities permit - either in sequence, in an alternating way, or through the combination of funds including for the joint funding of actions, allowing, where possible, innovation partnerships and blending operations. During the implementation of the Programme, the Commission should therefore promote synergies with other related Union programmes and financial instruments, which would allow, where possible, use of access to risk finance, innovation partnerships, and cumulative or blended funding. The Commission should also ensure synergies and coherence between the solutions developed under those programmes, particularly Horizon Europe, and the solutions developed under the Programme. (16) In accordance with Article 191(3) of the Financial Regulation, in no circumstances are the same costs to be financed twice by the Union budget. (17) The policy objectives of the Programme would also be addressed as eligible areas for financing and investment operations through financial instruments and budgetary guarantee of the InvestEU Programme, in particular under its sustainable infrastructure and research, innovation and digitisation policy windows. Financial support should be used to address market failures or sub-optimal investment situations in a proportionate manner, and actions should not duplicate or crowd out private financing or distort competition in the internal market. Actions should have a clear European added value. (18) Coherence and synergies between Horizon Europe and the Programme should foster a competitive and innovative European space sector, reinforce Europe\u2019s autonomy in accessing and using space in a secure and safe environment and strengthen Europe\u2019s role as a global actor. Breakthrough solutions in Horizon Europe would be supported by data and services made available by the Programme to the research and innovation community. (19) To maximise the socio-economic return from the Programme, it is essential to maintain state-of-the-art systems, to upgrade them to meet evolving users\u2019 needs and that new developments occur in the space-enabled downstream applications sector. The Union should support activities relating to research and technology development, or the early phases of evolution relating to the infrastructures established under the Programme, as well as the research and development activities relating to applications and services based on the systems established under the programme, thereby stimulating upstream and downstream economic activities. The appropriate instrument at Union level to finance those research and innovation activities is Horizon Europe. However, a very specific part of development activities should be financed from the budget allocated to the Galileo and EGNOS components under this Regulation, in particular where such activities concern fundamental elements such as Galileo-enabled chipsets and receivers, which would facilitate the development of applications across different sectors of the economy. Such financing should nevertheless not jeopardise the deployment or exploitation of the infrastructures established under the Programme. (20) To ensure the competitiveness of the European space industry in the future, the Programme should support the development of advanced skills in space-related fields and support education and training activities, promoting equal opportunities, including gender equality, in order to realise the full potential of Union citizens in that area. (21) Infrastructure dedicated to the Programme could require additional research and innovation, which could be supported under Horizon Europe, aiming for coherence with activities in this domain by ESA. Synergies with Horizon Europe should ensure that the research and innovation needs of the space sector are identified and established as part of the strategic research and innovation planning process. Space data and services made freely available by the Programme would be used to develop breakthrough solutions through research and innovation, including in Horizon Europe, in support of the Union\u2019s policy priorities. The strategic planning process under Horizon Europe would identify research and innovation activities that should make use of Union-owned infrastructure such as Galileo, EGNOS and Copernicus. Research infrastructures, in particular in-situ observing networks would constitute essential elements of the in-situ observation infrastructure enabling the Copernicus Services. (22) It is important that the Union own all tangible and intangible assets created or developed through public procurement that it finances as part of the Programme. In order to ensure full compliance with any fundamental rights relating to ownership, the necessary arrangements should be made with any existing owners. Such ownership by the Union should be without prejudice to the possibility for the Union, in accordance with this Regulation and where it is deemed appropriate on the basis of a case-by-case assessment, to make those assets available to third parties or to dispose of them. (23) To encourage the widest possible use of the services offered by the Programme, it would be useful to stress that data, information and services are provided without warranty, without prejudice to obligations imposed by legally binding provisions. (24) The Commission, in performing certain of its tasks of a non-regulatory nature, should be able to have recourse, as required and insofar as necessary, to the technical assistance of certain external parties. Other entities involved in the public governance of the Programme should also be able to make use of the same technical assistance in performing tasks entrusted to them under this Regulation. (25) This Regulation lays down a financial envelope for the entire duration of the Programme, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (6), for the European Parliament and the Council during the annual budgetary procedure. (26) Reflecting the importance of tackling climate change in accordance with the Union\u2019s commitments to implement the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (7), and the commitment to the UN Sustainable Development Goals, the actions under this Regulation should contribute to mainstream climate actions and to the achievement of an overall target of at least 30 % of the Union budget expenditure supporting climate objectives. Relevant actions should be identified during the Programme\u2019s preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. The European Parliament, the Council and the Commission will cooperate on an effective, transparent and comprehensive methodology, to be set out by the Commission, in order to assess the spending under all multiannual financial framework programmes to biodiversity objectives, while considering the existing overlaps between climate and biodiversity objectives. (27) Revenue generated by the Programme\u2019s components should accrue to the Union in order to partially offset the investments that it has already made, and that revenue should be used to support the achievement of the objectives of the Programme. For the same reason, it should be possible to provide for a revenue-sharing mechanism in contracts concluded with private sector entities. (28) The Financial Regulation applies to the Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (29) As the Programme is, in principle, financed by the Union, procurement contracts concluded under the Programme for activities financed by the Programme should comply with Union rules. In that context, the Union should also be responsible for defining the objectives to be pursued as regards public procurement. The Financial Regulation provides that, on the basis of the results of an ex ante assessment, the Commission is to be able to rely on the systems and the procedures of the persons or entities implementing Union funds. Specific adjustments necessary to those systems and procedures, as well as the arrangements for the prolongation of the existing contracts, should be defined in the corresponding financial framework partnership agreement (FFPA) or contribution agreement. (30) The Programme relies on complex and constantly changing technologies. The reliance on such technologies results in uncertainty and risk for public contracts concluded under the Programme, insofar as those contracts involve long-term commitments to equipment or services. Specific measures concerning public contracts are therefore required in addition to the rules laid down in the Financial Regulation. It should thus be possible to award a contract in the form of a conditional stage-payment contract, introduce an amendment, under certain conditions, in the context of its performance, or impose a minimum level of subcontracting, particularly in order to enable SMEs and start-ups to participate. Finally, given the technological uncertainties that characterise the Programme\u2019s components, contract prices cannot always be forecast accurately and it should therefore be possible to conclude contracts without stipulating a firm fixed price and to include clauses to safeguard the financial interests of the Union. (31) To foster public demand and public sector innovation, the Programme should promote the use of its data, information and services to support the development of customised solutions by industry and SMEs at regional and local levels through space-related innovation partnerships, as referred to in point 7 of Annex I to the Financial Regulation, allowing all stages, from development up to deployment and procurement of customised interoperable space solutions for public services, to be covered. (32) In order to meet the objectives of the Programme, it is important to be able to call, where appropriate, on capacities offered by Union public and private entities active in the space domain and also to be able to work at international level with third countries or international organisations. For that reason, provision should be made for the possibility of using all the relevant tools and management methods provided for by the TFEU and the Financial Regulation and joint procurement procedures. (33) On grants more specifically, experience has shown that user and market uptake and general outreach work better in a decentralised manner than top-down by the Commission. Vouchers, which are a form of financial support from a grant beneficiary to third parties, have been among the actions with the highest success rate to new entrants and SMEs. However, they have been hindered by the ceiling on financial support imposed by the Financial Regulation. That ceiling should therefore be raised for the Programme in order to keep pace with the growing potential of market applications in the space sector. (34) The forms of funding and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. This should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (35) Pursuant to Council Decision 2013/755/EU (8), persons and entities established in overseas countries or territories are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (36) Horizontal financial rules adopted by the European Parliament and by the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (37) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (9) and Council Regulations (EC, Euratom) No 2988/95 (10), (Euratom, EC) No 2185/96 (11) and (EU) 2017/1939 (12), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013 the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (13).In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (38) Members of the European Free Trade Association (EFTA) which are members of the European Economic Area (EEA), acceding countries, candidate countries and potential candidates as well as the European Neighbourhood Policy countries may participate in the Programme, with the exception of Galileo, EGNOS, GOVSATCOM and the SST sub-component, in accordance with their respective agreements. Other third countries may also participate in the Programme, with the exception of Galileo, EGNOS, GOVSATCOM and the SST sub-component, on the basis of an agreement to be concluded in accordance with Article 218 TFEU. Galileo and EGNOS should be open to the participation of the members of EFTA which are members of the EEA, in accordance with the conditions laid down in the Agreement on the European Economic Area (14). Other third countries may participate in Galileo and EGNOS on the basis of an agreement to be concluded in accordance with Article 218 TFEU. GOVSATCOM should be open to any third country only on the basis of an agreement to be concluded in accordance with Article 218 TFEU. (39) A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. (40) International organisations which do not have their headquarters in the Union and which wish to access the SST services which are not publicly available should be required to conclude an agreement in accordance with Article 218 TFEU. International organisations which have their headquarters in the Union and are public spacecraft owners and operators should be considered SST core users. (41) Publicly available information for SST services should be understood to mean any information that a user has a reasonable basis for finding lawfully accessible. Collision avoidance, re-entry and fragmentation SST services are based on external publicly accessible SST information which is available after a request for access. Consequently, collision avoidance, re-entry and fragmentation SST services should be understood as being publicly available services and should not require conclusion of an agreement in accordance with Article 218 TFEU. Access to them should be available at the request of the potential user. (42) Sound public governance of the Programme requires the clear distribution of responsibilities and tasks among the different entities involved to avoid unnecessary overlap and reduce cost overruns and delays. All the actors of the governance should support, in their field of competence and in accordance with their responsibilities, the achievement of the objectives of the Programme. (43) Member States have long been active in the field of space. They have systems, infrastructure, national agencies and bodies linked to space. They can therefore make a major contribution to the Programme, especially its implementation. They might cooperate with the Union to promote the Programme\u2019s services and applications. The Commission might be able to mobilise the means at Member States\u2019 disposal, benefit from their assistance and, subject to mutually agreed conditions, entrust the Member States with non-regulatory tasks in the implementation of the Programme. Moreover, the Member States concerned should take all necessary measures to ensure the protection of the ground stations established on their territories. In addition, Member States and the Commission should work together and with appropriate international bodies and regulatory authorities to ensure that the frequencies necessary for the Programme are available and protected at the adequate level to allow for the full development and implementation of applications based on the services offered, in compliance with Decision No 243/2012/EU of the European Parliament and of the Council (15). (44) As promoter of the Union\u2019s general interest, it is the Commission\u2019s responsibility to implement the Programme, assume overall responsibility and promote its use. In order to optimise the resources and competences of the various stakeholders, the Commission should be able to entrust certain tasks to other entities under justifiable circumstances. Having the overall responsibility for the Programme, the Commission should determine the main technical and operational requirements necessary to implement systems and services evolution. It should do so after having consulted Member States\u2019 experts, users and other relevant stakeholders. Finally, noting that in the area of space, in accordance with Article 4(3) TFEU, the exercise of competence by the Union does not result in Member States being prevented from exercising theirs, the Commission should ensure the coherence of activities performed in the context of the Programme. (45) The mission of the European Union Agency for the Space Programme (\u2018the Agency\u2019), which replaces and succeeds the European GNSS Agency established by Regulation (EU) No 912/2010 of the European Parliament and of the Council (16), is to contribute to the Programme, particularly as regards security accreditation as well as market and downstream applications development. Certain tasks linked to those areas should therefore be assigned to the Agency. In relation to security in particular, and given its experience in this area, the Agency should be responsible for the security accreditation tasks for all the Union actions in the space sector. Building on its positive track-record in promoting the user and market uptake of Galileo and EGNOS, the Agency should also be entrusted with user-uptake activities relating to the Programme\u2019s components other than Galileo and EGNOS, as well as downstream application development activities for all the Programme\u2019s components. This would allow the Agency to benefit from economies of scale and provide an opportunity for the development of applications based on several Programme\u2019s components (integrated applications). However, those activities should not prejudice the service and the user-uptake activities entrusted by the Commission to Copernicus entrusted entities. The entrustment of downstream applications development to the Agency should not prevent other entrusted entities from developing downstream applications. Furthermore, the Agency should perform the tasks which the Commission confers on it by means of one or more contribution agreements under an FFPA covering other specific tasks associated with the Programme. When entrusting tasks to the Agency, adequate human, administrative and financial resources should be made available. (46) In certain duly justified circumstances, the Agency should be able to entrust specific tasks to Member States or groups of Member States. That entrustment should be limited to activities the Agency does not have the capacity to execute itself and should not prejudice the governance of the Programme and the allocation of tasks as defined in this Regulation. (47) Galileo and EGNOS are complex systems that require intensive coordination. Since they are the Programme\u2019s components, that coordination should be performed by a Union institution or body. Building on the expertise developed in the past years, the Agency is the most appropriate body to coordinate all the operational tasks relating to the exploitation of those systems, except for the international cooperation. The Agency should therefore be entrusted with the management of the exploitation of EGNOS and Galileo. Nevertheless, this does not mean that the Agency should perform alone all the tasks relating to the exploitation of those systems. It could rely on the expertise of other entities, in particular ESA. This should include the activities on systems evolution, design and development of parts of the ground segment and satellites which should be entrusted to ESA. The allocation of tasks to other entities builds on the competences of such entities and should avoid duplication of work. (48) ESA is an international organisation with extensive expertise in the space domain and which concluded a Framework Agreement with the European Community in 2004 (\u20182004 Framework Agreement\u2019) (17). It is therefore an important partner in the implementation of the Programme, with which appropriate relations should be established. In that regard, and in compliance with the Financial Regulation, the Commission should conclude a FFPA with ESA and the Agency that governs all financial relations between the Commission, the Agency and ESA, ensures their consistency and conforms to the 2004 Framework Agreement, in particular with Articles 2 and 5 thereof. However, as ESA is not a Union body and is not subject to Union law, it is essential that such an agreement provides that ESA takes appropriate measures to ensure the protection of the interests of the Union and its Member States and, as regards budget implementation, that tasks entrusted to it comply with the decisions taken by the Commission. The agreement should also contain all the clauses necessary to safeguard the Union\u2019s financial interests. (49) The functioning of the European Union Satellite Centre (SATCEN) as a European autonomous capability providing access to information and services resulting from exploitation of relevant space assets and collateral data was already acknowledged in the implementation of Decision No 541/2014/EU of the European Parliament and of the Council (18). (50) To structurally embed the user representation in the governance of GOVSATCOM and to aggregate user needs and requirements across national and civil-military boundaries, the relevant Union entities with close user-ties, such as the European Defence Agency, the European Border and Coast Guard Agency (Frontex), the European Maritime Safety Agency, the European Fisheries Control Agency, the European Union Agency for Law Enforcement Cooperation, the Military Planning and Conduct Capability/Civilian Planning and Conduct Capability and the Emergency Response Coordination Centre may have coordinating roles for specific user groups. At an aggregated level the Agency should coordinate user-related aspects for the civilian user communities and may monitor operational use, demand, conformity with requirements and evolving needs and requirements. (51) Owing to the importance of space-related activities for the Union economy and the lives of Union citizens, the dual-use nature of the systems and of the applications based on those systems, achieving and maintaining a high degree of security should be a key priority for the Programme, particularly in order to safeguard the interests of the Union and of its Member States, including in relation to classified and other sensitive non-classified information. (52) Without prejudice to Member States\u2019 prerogatives in the area of national security, the Commission and the High Representative, each within their respective area of competence, should ensure the security of the Programme in accordance with this Regulation and, where relevant, Council Decision (CFSP) 2021/698 (19). (53) Given the specific expertise of the European External Action Service (EEAS) and its regular contact with authorities of third countries and international organisations, the EEAS may assist the Commission in performing certain of its tasks relating to the security of the Programme in the field of external relations, in accordance with Council Decision 2010/427/EU (20). (54) Without prejudice to the sole responsibility of the Member States in the area of national security, as provided for in Article 4(2) TEU, and to the right of the Member States to protect their essential security interests in accordance with Article 346 TFEU, a specific governance of security should be established to ensure a smooth implementation of the Programme. That governance should be based on three key principles. Firstly, it is imperative that Member States\u2019 extensive, unique experience in security matters be taken into consideration to the greatest possible extent. Secondly, in order to prevent conflicts of interest and any shortcomings in applying security rules, operational functions should be segregated from security accreditation functions. Thirdly, the entity in charge of managing all or part of the Programme\u2019s components is also the best placed to manage the security of the tasks entrusted to it. The security of the Programme would build upon the experience gained in the implementation of Galileo, EGNOS and Copernicus over the past years. Sound security governance also requires that roles be appropriately distributed among the various players. As it is responsible for the Programme, the Commission, without prejudice to Member States prerogatives in the area of national security, should determine the general security requirements applicable to each of the Programme\u2019s components. (55) The cybersecurity of European space infrastructures, both ground and space, is key to ensuring the continuity of the operations of the systems and service continuity. The need to protect the systems and their services against cyber-attacks, including by making use of new technologies, should therefore be duly taken into account when establishing security requirements. (56) A security monitoring structure should be identified by the Commission when appropriate after the risk and threat analysis. That security monitoring structure should be the entity responding to instructions developed under the scope of Decision (CFSP) 2021/698. For Galileo, that body should be the Galileo Security Monitoring Centre. With regard to the implementation of Decision (CFSP) 2021/698, the role of the Security Accreditation Board should be limited to providing the Council or the High Representative with inputs linked to the security accreditation of the system. (57) In view of the uniqueness and complexity of the Programme and its link to security, recognised and well-established principles should be followed for security accreditation. It is thus indispensable that security accreditation activities be carried out on the basis of collective responsibility for the security of the Union and its Member States, by endeavouring to build consensus and involving all those concerned with the issue of security, and that a procedure for permanent risk monitoring be put in place. It is also imperative that technical security accreditation activities be entrusted to professionals who are duly qualified in the field of accrediting complex systems and who have an adequate level of security clearance. (58) EU classified information (EUCI) is to be handled in accordance with the security rules as set out in Council Decision 2013/488/EU (21) and Commission Decision (EU, Euratom) 2015/444 (22). In accordance with Decision 2013/488/EU, the Member States are to respect the principles and minimum standards laid down therein, in order to ensure that an equivalent level of protection is afforded to EUCI. (59) To ensure the secure exchange of information, appropriate agreements should be established to ensure the protection of EUCI provided to third countries and international organisations in the context of the Programme. (60) An important objective of the Programme is to ensure its security and to strengthen strategic autonomy across key technologies and value chains, while preserving an open economy including free and fair trade, and taking advantage of the possibilities that space offers for the security of the Union and its Member States. In specific cases, that objective requires the requisite conditions for eligibility and participation to be set, to ensure the protection of the integrity, security and resilience of the operational systems of the Union. That should not undermine the need for competitiveness and cost-effectiveness. In the evaluation of legal entities subject to control by a third country or third country entity, the Commission should take into account the principles and criteria provided for in Regulation (EU) 2019/452 of the European Parliament and of the Council (23). (61) In the context of the Programme, there is some information which, although not classified, is to be handled in accordance with Union legal acts already in force or with national laws, rules and regulations, including through distribution limitations. (62) A growing number of key economic sectors, in particular transport, telecommunications, agriculture and energy, increasingly use satellite navigation and Earth observation systems. The Programme should exploit the synergies between those sectors, taking into consideration the benefits that space technologies bring to those sectors, support the development of compatible equipment and promote the development of relevant standards and certifications. Synergies between space activities and activities linked to the security and defence of the Union and its Member States are also increasing. Having full control of satellite navigation should therefore guarantee the Union\u2019s technological independence, including in the longer term for the components of infrastructure equipment, and ensure its strategic autonomy. (63) The aim of Galileo is to establish and operate the first global satellite navigation and positioning infrastructure specifically designed for civilian purposes, which can be used by a variety of public and private actors in Europe and worldwide. Galileo functions independently of other existing or potential systems, thus contributing amongst other things to the strategic autonomy of the Union. The second generation of Galileo should be progressively rolled out before 2030, initially with reduced operational capacity. (64) The aim of EGNOS is to improve the quality of open signals from existing global navigation satellite systems, in particular those emitted by Galileo. The services provided by EGNOS should cover, as a priority, the Member States\u2019 territories geographically located in Europe, including for that purpose Cyprus, the Azores, the Canary Islands and Madeira, by the end of 2026. In the aviation domain, all those territories should benefit from EGNOS for air navigation services for all the performance levels supported by EGNOS. Subject to technical feasibility and, for the safety of life, on the basis of international agreements, the geographical coverage of the services provided by EGNOS could be extended to other regions of the world. Without prejudice to Regulation (EU) 2018/1139 of the European Parliament and of the Council (24) and the necessary monitoring of Galileo service quality for aviation purposes, it should be noted that while the signals emitted by Galileo may effectively be used to facilitate the positioning of aircraft, in all phases of flight, through the necessary augmentation system, including regional, local and on-board avionics, only regional or local augmentation systems such as EGNOS in Europe may constitute air-traffic management (ATM) services and air navigation services (ANS). The EGNOS safety-of-life service should be provided in compliance with applicable standards of the International Civil Aviation Organisation (\u2018ICAO standards\u2019). (65) It is imperative to ensure the sustainability of the Galileo and EGNOS and the continuity, availability, accuracy, reliability and security of their services. In a changing environment and rapidly developing market, their development should also continue and new generations of those systems, including associated space and ground segment evolution, should be prepared. (66) The term \u2018commercial service\u2019 used in Regulation (EU) No 1285/2013 of the European Parliament and of the Council (25) is no longer suitable in the light of the evolution of that service. Instead, two separate services have been identified in Commission Implementing Decision (EU) 2017/224 (26), namely the high-accuracy service and the authentication service. (67) In order to optimise the use of the services provided, the services provided by Galileo and EGNOS should be compatible and interoperable with one another, including at user level, and, insofar as possible, with other satellite navigation systems and with conventional means of radio navigation where such compatibility and interoperability is laid down in an international agreement, without prejudice to the objective of strategic autonomy of the Union. (68) Considering the importance for Galileo and EGNOS of their ground-based infrastructure and the impact thereof on their security, the determination of the location of the infrastructure should be made by the Commission. The deployment of the ground-based infrastructure of the systems should continue to follow an open and transparent process, which could involve the Agency where appropriate based on its field of competence. (69) To maximise the socio-economic benefits of Galileo and EGNOS, while contributing to Union\u2019s strategic autonomy, particularly in sensitive sectors and in the area of safety and security, the use of the services provided by EGNOS and Galileo in other Union policies should be promoted also by regulatory means where that is justified and beneficial. Measures to encourage the use of those services in all Member States are also an important part of the process. (70) The Programme\u2019s components should stimulate the application of digital technology in space systems, data and service distribution, downstream development. In that context the particular attention should be given to the initiatives and actions proposed by the Commission in its Communications of 14 September 2016 entitled \u2018Connectivity for a Competitive Digital Single Market \u2013 Towards a European Gigabit Society\u2019 and Communication of 14 September 2016 entitled \u20185G for Europe: An Action Plan\u2019. (71) Copernicus should ensure an autonomous access to environmental knowledge and key technologies for Earth observation and geo-information services, thereby supporting the Union to achieve independent decision-making and actions in the fields of, inter alia, the environment, climate change, marine, maritime, agriculture and rural development, preservation of cultural heritage, civil protection, land and infrastructure monitoring, security, as well as the digital economy. (72) Copernicus should build on, ensure continuity with and enhance the activities and achievements under Regulation (EU) No 377/2014 of the European Parliament and of the Council (27) establishing the Union Earth observation and monitoring programme (Copernicus) as well as Regulation (EU) No 911/2010 of the European Parliament and of the Council (28) establishing the predecessor Global Monitoring for Environment and Security (GMES) programme and the rules for implementation of its initial operations, taking into account recent trends in research, technological advances and innovations impacting the Earth observation domain, as well as developments in big data analytics and artificial intelligence and related strategies and initiatives at Union level as outlined by the Commission in its White Paper On Artificial Intelligence of 19 February 2020 entitled \u2018A European approach to excellence and trust\u2019 and its Communication of 19 February 2020 entitled \u2018A European strategy for data\u2019. For the development of new assets, the Commission should work closely with Member States, ESA, the European Organisation for the Exploitation of Meteorological Satellites (EUMETSAT) and, where appropriate, other entities owning relevant space and in-situ assets. To the greatest extent possible, Copernicus should make use of capacities for space-based Earth observations of the Member States, ESA, EUMETSAT, as well as other entities, including commercial initiatives in the Union, thereby also contributing to the development of a viable commercial space sector in Europe. Where feasible and appropriate, Copernicus should also make use of the available in-situ and ancillary data provided mainly by the Member States in accordance with Directive 2007/2/EC of the European Parliament and of the Council (29). The Commission should work together with the Member States and the European Environment Agency to ensure an efficient access and use of the in-situ data sets for Copernicus. (73) Copernicus should be implemented in accordance with the objectives of Directive 2003/98/EC of the European Parliament and of the Council (30), in particular transparency, the creation of conditions conducive to the development of services, and contributing to economic growth and job creation in the Union. Copernicus data and Copernicus information should be available freely and openly. (74) The full potential of Copernicus for the Union\u2019s society and economy should be fully unleashed beyond direct beneficiaries by means of an intensification of user uptake measures, which requires further action to render the data usable by non-specialists and thereby stimulate growth, job creation and knowledge transfers. (75) Copernicus is a user-driven programme. Its evolution should therefore be based on the evolving requirements of the Copernicus core users, while also recognising the emergence of new user communities, whether public or private. Copernicus should base itself on an analysis of options to meet evolving user needs, including those related to implementation, and monitoring of Union policies which require the continuous, effective involvement of users, particularly regarding the definition and validation of requirements. (76) Copernicus is already operational. It is therefore important to ensure the continuity of the infrastructure and services already in place, whilst adapting to the changing user needs, market environment, particularly the emergence of private actors in space and socio-political developments for which a rapid response is needed. That requires an evolution of the functional structure of Copernicus to better reflect the shift from the first stage of operational services to the provision of advanced and more targeted services to new user communities and the fostering of added-value downstream markets. To that end, its further implementation should adopt an approach following the data value chain, i.e. data acquisition, data and information processing, distribution and exploitation, user, market uptake and capacity building activities, while the strategic planning process under Horizon Europe would identify research and innovation activities that should make use of Copernicus. (77) With regard to data acquisition, the activities under Copernicus should aim at completing and maintaining the existing space infrastructure, preparing the long-term replacement of the satellites at the end of their lifetime, as well as initiating new missions addressing in particular new observation systems to support meeting the challenge of global climate change, such as anthropogenic CO2 and other greenhouse gas emissions monitoring. Activities under Copernicus should expand their global monitoring coverage over the polar regions and support environmental compliance assurance, statutory environmental monitoring and reporting and innovative environmental applications in agriculture, forest, water and marine resources management and cultural heritage, such as for crops monitoring, water management and enhanced fire monitoring. In doing so, Copernicus should leverage and take maximum advantage of the investments made under the previous funding period (2014-2020), including those made by Member States, ESA and EUMETSAT, while exploring new operational and business models to further complement the Copernicus capacities. Copernicus might also build on successful partnerships with Member States to further develop its security dimension under appropriate governance mechanisms, in order to respond to evolving user needs in the security domain. (78) As part of the data and information processing function, Copernicus should ensure the long-term sustainability and further development of Copernicus Services, providing information in order to satisfy public sector needs and those arising from the Union\u2019s international commitments, and to maximise opportunities for commercial exploitation. In particular, Copernicus should deliver, at the European, national, local and global scale, information on the composition of the atmosphere and air quality; information on the state and dynamics of the oceans; information in support of land and ice monitoring supporting the implementation of Union, national and local policies; information in support of climate change adaptation and mitigation; geospatial information in support of emergency management, including through prevention activities, environmental compliance assurance, as well as civil security including support for the Union\u2019s external action. The Commission should identify appropriate contractual arrangements fostering the sustainability of service provision. (79) In the implementation of the Copernicus Services, the Commission should rely on competent entities, relevant Union agencies, groupings or consortia of national bodies, or any relevant body potentially eligible for conclusion of a contribution agreement. In the selection of those entities, the Commission should ensure that there is no disruption in the operations and provision of services and that, as regards security-sensitive data, the entities concerned have early warning and crisis monitoring capabilities within the context of the Common Foreign and Security Policy and, in particular, of the Common Security and Defence Policy. In accordance with Article 154(2) of the Financial Regulation, persons and entities entrusted with the implementation of Union funds are obliged to comply with the principle of non-discrimination towards all Member States. Compliance with that principle should be ensured through the relevant contribution agreements relating to the provision of the Copernicus Services. (80) The implementation of the Copernicus Services should facilitate the public uptake of services as users would be able to anticipate the availability and evolution of services as well as cooperation with Member States and other parties. To that end, the Commission and its entrusted entities providing services should engage closely with Copernicus core users\u2019 communities across Europe in further developing the Copernicus Services and information portfolio to ensure that evolving public sector and policy needs are met and thus the uptake of Earth observation data can be maximised. The Commission and Member States should work together to develop the in-situ component of Copernicus and to facilitate the integration of Copernicus in-situ data with space datasets for upgraded Copernicus Services. (81) Copernicus\u2019 free, full and open data policy has been evaluated as one of the most successful elements of Copernicus\u2019 implementation and has been instrumental in driving strong demand for its data and information, establishing Copernicus as one of the largest Earth observation data providers in the world. There is a clear need to guarantee the long-term and secure continuity of the free, full and open data provision and access should be safeguarded in order to realise the ambitious goals as set out in the Space Strategy for Europe. Copernicus data is created primarily for the benefit of the Europeans, and by making that data freely available worldwide collaboration opportunities are maximised for Union businesses and academics and contribute to an effective European space ecosystem. Should any limitation be placed on the access to Copernicus data and Copernicus information, it should be in line with the Copernicus data policy as laid down in this Regulation and in Commission Delegated Regulation (EU) No 1159/2013 (31). (82) The data and information produced in the framework of Copernicus should be made available on a full, open and free-of-charge basis subject to appropriate conditions and limitations, in order to promote their use and sharing, and to strengthen the European Earth observation markets, in particular the downstream sector, thereby enabling growth and job creation in the Union. Such provision should continue to provide data and information with high levels of consistency, continuity, reliability, and quality. This calls for large-scale and user-friendly access to, processing and exploitation of Copernicus data and Copernicus information, at various timeliness levels, for which the Commission should continue to follow an integrated approach, both at Union and Member States level, enabling also integration with other sources of data and information. Therefore the Commission should take the necessary measures to ensure that Copernicus data and Copernicus information is easily and efficiently accessible and usable, particularly by promoting the Data and Information Access Services (DIAS) within Member States and when possible fostering interoperability between the existing European Earth observation data infrastructures to establish synergies with those assets in order to maximise and strengthen market uptake of Copernicus data and Copernicus information. (83) The Commission should work with data providers to agree licensing conditions for third-party data to facilitate their use within Copernicus, in compliance with this Regulation and applicable third-party rights. As some Copernicus data and Copernicus information, including high-resolution images, may have an impact on the security of the Union or Member States, in duly justified cases, measures in order to deal with risks and threats to the security of the Union or Member States may be adopted. (84) To promote and facilitate the use of Earth observation data and technologies by national, regional and local authorities, SMEs, scientists and researchers, dedicated networks for Copernicus data distribution, including national and regional bodies such as Copernicus Relays and Copernicus Academies, should be promoted through user uptake activities. To that end, the Commission and the Member States should strive to establish closer links between Copernicus and Union and national policies in order to drive the demand for commercial applications and services and enable enterprises, in particular SMEs and start-ups, to develop applications based on Copernicus data and Copernicus information aiming at developing a competitive Earth observation data eco-system in Europe. (85) In the international domain, Copernicus should provide accurate and reliable information for cooperation with third countries and international organisations, and in support of the Union\u2019s external and development cooperation policies. Copernicus should be considered as a European contribution to the Global Earth Observation System of Systems, the Committee on Earth Observation Satellites, the Conference of the Parties to the 1992 United Nations Framework Convention on Climate Change, the achievement of the UN Sustainable Development Goals and the Sendai Framework for Disaster Risk Reduction. The Commission should establish or maintain appropriate cooperation with relevant sectoral UN bodies and the World Meteorological Organisation. (86) In the implementation of Copernicus, the Commission should rely, where appropriate, on European international organisations with which it has already established partnerships, in particular ESA, for the development, coordination, implementation and evolution of the space components, access to third party data where appropriate and, when not undertaken by other entities, the operation of dedicated missions. In addition, the Commission should rely on EUMETSAT for the operation of dedicated missions or parts thereof and, where appropriate, access to contributing mission data in accordance with its expertise and mandate. (87) In the domain of services, the Commission should benefit appropriately from the specific capacities provided by Union agencies, such as the European Environment Agency, the European Maritime Safety Agency, Frontex, SATCEN, as well as the intergovernmental European Centre for Medium-Range Weather Forecasts and the European investments already made in marine environment monitoring services through Mercator Ocean. On security, a comprehensive approach at Union level would be sought with the High Representative. The Joint Research Centre (JRC) of the Commission has been actively involved from the start of the GMES initiative and has supported developments for Galileo and the SWE sub-component. Under Regulation (EU) No 377/2014, the JRC is managing the Copernicus emergency management service and the global component of the Copernicus land monitoring service, it is contributing to the review of the quality and fitness for purpose of data and information, and to the future evolution. The Commission should continue relying on JRC\u2019s scientific and technical advice for the implementation of the Programme. (88) Following the requests of the European Parliament and of the Council, the Union established a support framework for space surveillance and tracking (SST) by means of Decision No 541/2014/EU. Space debris has become a serious threat to the security, safety and sustainability of space activities. The SST sub-component is therefore essential to preserving the continuity of the Programme\u2019s components and their contributions to Union policies. By seeking to prevent the proliferation of space debris, the SST sub-component contributes to ensuring the sustainable and guaranteed access to and use of space, which is a global common objective. In that context, it could support the preparation of European Earth orbit \u2018clean-up\u2019 projects. (89) The performance and autonomy of capabilities under the SST sub-component should be further developed. To that end, the SST sub-component should lead to the establishment of an autonomous European catalogue of space objects, building on data from the network of SST sensors. Where appropriate, the Union could consider making some of its data available for commercial, non-commercial and research purposes. The SST sub-component should also continue to support the operation and provision of SST services. As SST services are user-driven, appropriate mechanisms should be put in place to collect user requirements, including those relating to security and the transmission of relevant information to and from public institutions to improve the effectiveness of the system, while respecting national safety and security policies. (90) The provision of SST services should be based on cooperation between the Union and the Member States and on the use of existing as well as future national expertise and assets, including those developed through ESA or by the Union. It should be possible to provide financial support for the development of new SST sensors. In view of the sensitive nature of the SST, the control over national sensors and their operations, maintenance and renewal and the processing of data leading to the provision of SST services should remain with the Member States participating in the SST sub-component. (91) Member States with ownership or access to adequate capabilities available for the SST sub-component should be able to participate in the provision of SST services. Participating Member States in the Consortium established under Decision No 541/2014/EU should be deemed to have ownership or access to adequate capabilities available for the SST sub-component. Member States wishing to participate in the provision of SST services should submit a single joint proposal and demonstrate compliance with further elements related to the operational set up. Appropriate rules should be established for the selection and organisation of those Member States. (92) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission relating to adoption of the detailed procedures and elements for establishing the participation of Member States in the provision of SST services. Where no joint proposal of the Member States wishing to participate in the provision of SST services has been submitted or where the Commission considers that such proposal does not comply with the criteria set, the Commission should be able to initiate a second step for establishing the participation of Member States in the provision of SST services. The procedures and elements for that second step should define the orbits to be covered, and take into account the need to maximise the participation of Member States in the provision of SST services. Where those procedures and elements provide for the possibility for the Commission to select several proposals to cover all the orbits, appropriate coordination mechanisms between the groups of Member States and an efficient solution to cover all the SST services should also be provided. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (32). (93) Once the SST sub-component is set up, it should respect the principles of complementarity of activities and continuity of high quality user-driven SST services, and be based on the best expertise. The SST sub-component should therefore avoid unnecessary duplication. Redundant capabilities should ensure SST services\u2019 continuity, quality and robustness. The activities of the Expert Teams should help to avoid such unnecessary duplication. (94) In addition, the SST sub-component should be conducive to existing mitigation measures, such as the COPUOS Space Debris Mitigation Guidelines and Guidelines for the Long-term Sustainability of Outer Space Activities, or other initiatives to ensure the safety, security and sustainability of outer space activities. With a view to reducing risks of collision, the SST sub-component would also seek synergies with initiatives of active removal and passivation measures of space debris. The SST sub-component should contribute to ensuring the peaceful use and exploration of outer space. The increase in space activities may have implication on the international initiatives in the area of the space traffic management. The Union should monitor those developments and may take them into consideration in the context of the mid-term review of the current multiannual financial framework. (95) The activities under the SST, SWE and NEO sub-components should have regard to cooperation with international partners, in particular the United States, international organisations and other third parties, particularly to avoid collisions in space, to prevent the proliferation of space debris and to increase preparedness for the effects of extreme space weather events and near-Earth objects. (96) The Security Committee of the Council recommended the creation of a risk management structure to ensure that data security issues are duly taken into account in the implementation of Decision No 541/2014/EU. For that purpose and taking account of the work already performed, the appropriate risk management structures and procedures should be established by the Member States participating in the SST sub-component. (97) Extreme and major space weather events may threaten the safety of citizens and disrupt the operations of space-based and ground-based infrastructure. A SWE sub-component should therefore be established as part the Programme with an aim of assessing the space weather risks and corresponding user needs, raising the awareness of space weather risks, ensuring the provision of user-driven SWE services, and improving Member States\u2019 capabilities to provide the SWE services. The Commission should prioritise the sectors to which the operational SWE services are to be provided taking into account the user needs, risks and technological readiness. In the long term, the needs of other sectors may be addressed. The provision of services at Union level according to the users\u2019 needs would require targeted, coordinated and continued research and development activities to support SWE services evolution. The provision of the SWE services should build on the existing national and Union capabilities and enable a broad participation of Member States, European and international organisations, and involvement of the private sector. (98) The Commission White Paper of 1 March 2017 on the future of Europe, the Rome Declaration of the Heads of State and Government of 27 EU Member States of 25 March 2017, and several European Parliament resolutions, recall that the Union has a major role to play in ensuring a safe, secure and resilient Europe that is capable of addressing challenges such as regional conflicts, terrorism, cyber threats, and growing migration pressures. Secure and guaranteed access to satellite communications is an indispensable tool for security actors, and pooling and sharing of that key security resource at Union level strengthens a Union that protects its citizens. (99) The conclusions of the European Council of 19-20 December 2013 welcomed the preparations for the next generation of Governmental Satellite Communication (GOVSATCOM) through close cooperation between the Member States, the Commission and ESA. GOVSATCOM has also been identified as one of the elements of the Global Strategy for the European Union\u2019s Foreign and Security Policy of June 2016. GOVSATCOM should contribute to the EU response to Hybrid Threats and provide support to the EU Maritime Security Strategy and to the EU Arctic policy. (100) GOVSATCOM is a user-centric programme with a strong security dimension. The GOVSATCOM use-cases should be able to be analysed by the relevant actors for three main families: crisis management, which may include civilian and military Common Security and Defence missions and operations, natural and man-made disasters, humanitarian crises, and maritime emergencies; surveillance, which may include border surveillance, pre-frontier surveillance, sea-border surveillance, maritime surveillance and surveillance of illegal trafficking; and key infrastructures, which may include diplomatic network, police communications, digital infrastructure, such as data centres and servers, critical infrastructures, such as energy, transport and water barriers, such as dams, and space infrastructures. (101) GOVSATCOM capacity and services should be used in security and safety critical missions and operations by Union and Member State actors. Therefore an appropriate level of non-dependence from third parties (third countries and entities from third countries) is needed, covering all GOVSATCOM elements, such as space and ground technologies at component, subsystem and system level, manufacturing industries, owners and operators of space systems, and physical location of ground system components. (102) Satellite communications is a finite resource limited by the satellite capacity, frequency and geographical coverage. Therefore, in order to be cost-effective and to capitalise on economies of scale, GOVSATCOM needs to optimise the match between the demand from GOVSATCOM users, and the supply provided under contracts for GOVSATCOM capacities and services. Since the demand and the potential supply both change with time, this requires constant monitoring and flexibility to adjust GOVSATCOM services. (103) Operational requirements should be based on the use-case analysis. From those operational requirements, in combination with security requirements, the service portfolio should be developed. The service portfolio should establish the applicable baseline for the GOVSATCOM services. In order to maintain the best possible match between the demand and supplied services, the service portfolio for GOVSATCOM services should be able to be regularly updated. (104) In the first phase of GOVSATCOM, approximately until 2025, existing capacity would be used. In that context, the Commission should procure GOVSATCOM capacities from Member States with national systems and space capacities and from commercial satellite communication or service providers, taking into account the essential security interests of the Union. In that first phase GOVSATCOM services would be introduced in a stepped approach. If in the course of the first phase a detailed analysis of future supply and demand reveals that this approach is insufficient to cover the evolving demand, it should be possible to take a decision to move to a second phase and develop additional bespoke space infrastructure or capacities through one or several public-private partnerships, e.g. with Union satellite operators. (105) In order to optimise the available satellite communication resources, to guarantee access in unpredictable situations, such as natural disasters, and to ensure operational efficiency and short turn-around times, the necessary ground segment, such as GOVSATCOM Hubs and potential other ground elements, is required. It should be designed on the basis of operational and security requirements. In order to mitigate risks a GOVSATCOM Hub may consist of several physical sites. Other ground segment elements, such as anchoring stations, may be needed. (106) For users of satellite communications the user equipment is the all-important operational interface. The GOVSATCOM approach should make it possible for most users to continue to use their existing user equipment for GOVSATCOM services. (107) In the interest of operational efficiency, users have indicated that it is important to aim for interoperability of user equipment, and user equipment that can make use of different satellite systems. Research and development in this domain may be required. (108) At implementation level the tasks and responsibilities should be distributed amongst specialised entities, such as EDA, EEAS, ESA, the Agency, and other Union agencies in such a manner as to ensure that they align with their principal role, especially for user-related aspects. (109) The competent GOVSATCOM authority has an important role in terms of monitoring whether users, and other national entities that play a role in GOVSATCOM, comply with the sharing and prioritisation rules and security procedures as laid down in the security requirements. A Member State which has not designated a competent GOVSATCOM authority should in any event designate a point of contact for the management of any detected jamming affecting GOVSATCOM. (110) Member States, the Council, the Commission and the EEAS should be able to become GOVSATCOM participants, insofar as they choose to authorise GOVSATCOM users or provide capacities, sites or facilities. Taking into consideration that it is for the Member States to decide whether to authorise GOVSATCOM users or provide capacities, sites or facilities, Member States could not be obliged to become GOVSATCOM participants or to host GOVSATCOM infrastructure. The GOVSATCOM component would therefore be without prejudice to the right of Member States not to participate in GOVSATCOM, including in accordance with its national law or constitutional requirements in relation to policies concerning non-alignment and non-participation in military alliances. (111) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission relating to adoption of the operational requirements for GOVSATCOM services and of the service portfolio for GOVSATCOM services. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. (112) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission relating to adoption of detailed rules on sharing and prioritisation for the use of pooled GOVSATCOM satellite communication capacities. When defining detailed rules on sharing and prioritisation, the Commission should take into account the operational and security requirements and an analysis of risks and expected demand by GOVSATCOM participants. Although GOVSATCOM services should in principle be provided free of charge to GOVSATCOM users, if that analysis concludes there is a shortage of capacities and in order to avoid a distortion of the market, a pricing policy might be developed as part of those detailed rules on sharing and prioritisation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. (113) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers relating to the location of the ground segment infrastructure for GOVSATCOM should be conferred on the Commission. For the selection of such locations, the Commission should be able to take into account the operational and security requirements, as well as the existing infrastructure. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. (114) Regulation (EU) No 912/2010 established a Union agency, called the European GNSS Agency, to manage certain aspects of the Galileo and EGNOS satellite navigation programmes. This Regulation entrusts the European GNSS Agency with new tasks, especially security accreditation, not only in respect of Galileo and EGNOS but also in respect of other Programme\u2019s components. The name, tasks and organisational aspects of the European GNSS Agency should therefore be adapted accordingly. (115) In accordance with Decision 2010/803/EU (33), the seat of the Agency is located in Prague. For the implementation of the Agency\u2019s tasks, staff of the Agency might be located in one of the Galileo or EGNOS ground-based centres referred to in Commission Implementing Decision (EU) 2016/413 (34) to execute Programme activities provided for in the relevant agreement. In addition, for the Agency to operate in the most efficient and effective manner, a limited number of staff could be assigned to local offices in one or more Member States. Such assignment of staff outside the seat of the Agency or Galileo and EGNOS ground-based centres should not lead to transfer of the Agency\u2019s core activities to such local offices. (116) In view of its extended scope, which should no longer be limited to Galileo and EGNOS, the name of the European GNSS Agency should henceforth be changed. However, the continuity of the activities of the European GNSS Agency, including continuity as regards rights and obligations, staff and the validity of any decisions taken, should be ensured under the Agency. (117) Given the Agency\u2019s mandate and the role of the Commission in implementing the Programme, it is appropriate to provide that some of the decisions taken by the Administrative Board should not be adopted without the favourable vote of the representatives of the Commission. (118) Without prejudice to the powers of the Commission, the Administrative Board, the Security Accreditation Board and the Executive Director should be independent in the performance of their duties and should act in the public interest. (119) It is possible, and indeed probable, that some of the Programme\u2019s components would be based on the use of sensitive or security-related national infrastructure. In such cases, for reasons of national security, it would be necessary to stipulate that meetings of the Administrative Board and Security Accreditation Board be attended by the representatives of the Member States and the representatives of the Commission, on a need-to-know basis. In the Administrative Board, only those representatives of Member States which possess such infrastructure and a representative of the Commission are to take part in voting. The rules of procedure of the Administrative Board and of the Security Accreditation Board should set out the situations in which that procedure is to apply. (120) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (35), this Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Programme on the ground. (121) The use of Copernicus and Galileo-based services is predicted to have a major impact in the European economy in general. However, ad hoc measurements and case studies seem to dominate the picture today. The Commission (Eurostat) should define relevant statistical measurements and indicators that would form the basis for monitoring the impact of the Union\u2019s space activities in a systematic and authoritative way. (122) The European Parliament and the Council should be promptly informed of the work programmes. (123) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission relating to the reallocation of funds between the categories of expenditure of the Programme\u2019s budget, the adoption of contribution decisions regarding the contribution agreements, determining the technical and operational requirements needed for the implementation of and evolution of the Programme\u2019s components and of the services they provide, deciding on the FFPA, the adoption of measures necessary for the smooth functioning of Galileo and EGNOS and their adoption by the market, the adoption of the detailed provisions concerning the access to SST services and relevant procedures, the adoption of the multiannual plan and the key performance indicators for development of Union SST services, the adoption of detailed rules on the functioning of the organisational framework of the participation of Member States in the SST sub-component, the selection of SWE services, and the adoption of the work programmes. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. The Commission should be assisted by the Programme committee, which should meet in specific configuration. (124) Since the Programme\u2019s components are user-driven, they require the continuous, effective involvement of users for their implementation and development, particularly regarding the definition and validation of service requirements. In order to increase the value for the users, their input should be actively sought through regular consultation with end-users from the public and private sectors of Member States and, where appropriate, with international organisations. For that purpose, a working group (\u2018User Forum\u2019) should be set up to assist the Programme committee with the identification of user requirements, and the verification of service compliance, as well as the identification of gaps in services provided. The rules of procedure of the Programme committee should establish the organisation of the User Forum to take into account the specificities of each of the Programme\u2019s components and each service within the components. Whenever possible, Member States should contribute to the User Forum based on a systematic and coordinated consultation of users at national level. (125) As sound public governance requires uniform management of the Programme, faster decision-making and equal access to information, representatives of the entities entrusted with tasks related to the Programme might be able to take part as observers in the work of the Programme committee established in application of Regulation (EU) No 182/2011. For the same reasons, representatives of third countries and international organisations who have concluded an international agreement with the Union, relating to the Programme or its components or sub-components, might be able to take part in the work of the Programme committee subject to security constraints and as provided for in the terms of such agreement. The representatives of entities entrusted with tasks related to the Programme, third countries and international organisations should not be entitled to take part in the Programme committee voting procedures. The conditions for the participation of observers and ad hoc participants should be laid down in the rules of procedure of the Programme committee. (126) In order to ensure effective assessment of progress of the Programme towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing the provisions on the Copernicus data and Copernicus information to be provided to Copernicus users as regards the specifications and conditions and procedures for the access to and use of such data and such information, of amending the Annex to this Regulation with regard to the indicators where considered necessary and of supplementing this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (127) Since the objective of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects of the action that go beyond the financial and technical capacities of any single Member State, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (128) In order to ensure uniform conditions for the implementation of the Programme\u2019s security requirements, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. Member States should be able to exert a maximum of control over the Programme\u2019s security requirements. When adopting implementing acts in the area of security of the Programme, the Commission should be assisted by the Programme committee meeting in a dedicated security configuration. In view of the sensitivity of security matters, the chair of the Programme committee should endeavour to find solutions which command the widest possible support within the committee. The Commission should not adopt implementing acts determining the general security requirements of the Programme in cases where no opinion is delivered by the Programme committee. (129) The Programme should be established for a period of seven years to align its duration with that of the multiannual financial framework for the years 2021 to 2027 laid down in Council Regulation (EU, Euratom) 2020/2093 (36) (the \u2018MFF 2021-2027\u2019). The Agency, which carries out its own tasks, should not be subject to that time limitation. (130) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the MFF 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021. (131) Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU should therefore be repealed, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the Union Space Programme (\u2018the Programme\u2019) for the duration of the MFF 2021-2027. It lays down the objectives of the Programme, the budget for the period 2021-2027, the forms of Union funding and the rules for providing such funding, as well as the rules for the implementation of the Programme. This Regulation establishes the European Union Agency for the Space Programme (\u2018the Agency\u2019) which replaces and succeeds the European GNSS Agency established by Regulation (EU) No 912/2010 and lays down the rules of operation of the Agency. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018spacecraft\u2019 means an orbiting object designed to perform a specific function or mission, such as communications, navigation or Earth observation, including satellites, launcher upper stages, and a re-entry vehicle; a spacecraft that can no longer fulfil its intended mission is considered non-functional; spacecraft in reserve or standby modes awaiting possible reactivation are considered functional; (2) \u2018space object\u2019 means any man-made object in outer space; (3) \u2018near-Earth objects\u2019 or \u2018NEO\u2019 means natural objects in the solar system which are approaching the Earth; (4) \u2018space debris\u2019 means any space object including spacecraft or fragments and elements thereof in Earth\u2019s orbit or re-entering Earth\u2019s atmosphere, that are non-functional or no longer serve any specific purpose, including parts of rockets or artificial satellites, or inactive artificial satellites; (5) \u2018space weather events\u2019 or \u2018SWE\u2019 means naturally occurring variations in the space environment at the Sun and around the Earth, including solar flares, solar energetic particles, variations in the solar wind, coronal mass ejections, geomagnetic storms and dynamics, radiation storms and ionospheric disturbances, potentially impacting Earth and space-based infrastructures; (6) \u2018space situational awareness\u2019 or \u2018SSA\u2019 means a holistic approach, including comprehensive knowledge and understanding, of the main space hazards, encompassing collision between space objects, fragmentation and re-entry of space objects into the atmosphere, space weather events, and near-Earth objects; (7) \u2018space surveillance and tracking system\u2019 or \u2018SST system\u2019 means a network of ground-based and space-based sensors capable of surveying and tracking space objects, together with processing capabilities aiming to provide data, information and services on space objects that orbit around the Earth; (8) \u2018SST sensor\u2019 means a device or a combination of devices, such as ground-based or space-based radars, lasers and telescopes, which is able to perform space surveillance or tracking and that can measure physical parameters related to space objects, such as size, location and velocity; (9) \u2018SST data\u2019 means physical parameters of space objects, including space debris, acquired by SST sensors, or orbital parameters of space objects derived from SST sensors\u2019 observations in the framework of the SST sub-component; (10) \u2018SST information\u2019 means processed SST data which are readily meaningful to the recipient; (11) \u2018return link\u2019 means a functional capacity of the Galileo search and rescue support (SAR) service; the Galileo SAR service will contribute to the global monitoring service of aircraft, as defined by the International Civil Aviation Organisation (ICAO); (12) \u2018Copernicus Sentinels\u2019 means the Copernicus dedicated satellites, spacecraft or spacecraft payloads for space-based Earth observation; (13) \u2018Copernicus data\u2019 means data provided by the Copernicus Sentinels, including their metadata; (14) \u2018Copernicus third-party data and information\u2019 means spatial data and information licensed or made available for use under Copernicus which originate from sources other than the Copernicus Sentinels; (15) \u2018Copernicus in-situ data\u2019 means observation data from ground-based, seaborne or airborne sensors, as well as reference and ancillary data licensed or provided for use in Copernicus; (16) \u2018Copernicus information\u2019 means information generated by the Copernicus Services following processing or modelling, including their metadata; (17) \u2018Copernicus Participating States\u2019 means third countries which contribute financially and participate in Copernicus under the terms of an international agreement concluded with the Union; (18) \u2018Copernicus core users\u2019 means the Union institutions and bodies and European, national, or regional public bodies in the Union or Copernicus Participating States entrusted with a public service mission for the definition, implementation, enforcement or monitoring of civilian public policies, such as environmental, civil protection, safety, including safety of infrastructure, or security policies, which benefit from Copernicus data and Copernicus information and have the additional role of driving the evolution of Copernicus; (19) \u2018other Copernicus users\u2019 means research and education organisations, commercial and private bodies, charities, non-governmental organisations and international organisations, which benefit from Copernicus data and Copernicus information; (20) \u2018Copernicus users\u2019 means Copernicus core users and other Copernicus users; (21) \u2018Copernicus Services\u2019 means value-added services of general and common interest to the Union and the Member States, which are financed by the Programme and which transform Earth observation data, Copernicus in-situ data and other ancillary data into processed, aggregated and interpreted information tailored to the needs of Copernicus users; (22) \u2018GOVSATCOM user\u2019 means a public authority, a body entrusted with the exercise of public authority, an international organisation or a natural or legal person, duly authorised and entrusted with tasks relating to the supervision and management of' security-critical missions, operations and infrastructures; (23) \u2018GOVSATCOM Hub\u2019 means an operational centre the main function of which is to link, in a secure manner, the GOVSATCOM users to the providers of GOVSATCOM capacity and services and thereby optimise the supply and demand at any given moment; (24) \u2018GOVSATCOM use-case\u2019 means an operational scenario in a particular environment in which GOVSATCOM services are required; (25) \u2018EU classified information\u2019 or \u2018EUCI\u2019 means any information or material designated by an EU security classification, the unauthorised disclosure of which could cause varying degrees of prejudice to the interests of the Union or of one or more of the Member States; (26) \u2018sensitive non-classified information\u2019 means non-classified information within the meaning of Article 9 of Commission Decision (EU, Euratom) 2015/443 (37), under which an obligation to protect sensitive non-classified information applies solely to the Commission and to Union agencies and bodies obliged by law to apply the security rules of the Commission; (27) \u2018blending operation\u2019 means actions supported by the Union budget, including within blending facilities pursuant to Article 2(6) of the Financial Regulation, combining non-repayable forms of support or financial instruments or budgetary guarantees from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; (28) \u2018legal entity\u2019 means a natural person, or a legal person created and recognised as such under Union, national, or international law, which has legal personality and capacity to act in its own name, exercise rights and be subject to obligations, or an entity which does not have legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (29) \u2018fiduciary entity\u2019 means a legal entity that is independent from the Commission or a third party and that receives data from the Commission or that third party for the purpose of safe storage and treatment of those data. Article 3 Components of the Programme 1. The Programme shall consist of the following components: (a) \u2018Galileo\u2019, an autonomous civil global navigation satellite system (GNSS) under civil control, which consists of a constellation of satellites, centres and a global network of stations on the ground, offering positioning, navigation and timing services and integrating the needs and requirements of security; (b) \u2018European Geostationary Navigation Overlay Service\u2019 (EGNOS), a civil regional satellite navigation system under civil control which consists of centres and stations on the ground and several transponders installed on geosynchronous satellites and which augments and corrects the open signals emitted by Galileo and other GNSSs, inter alia for air-traffic management, for air navigation services and for other transport systems; (c) \u2018Copernicus\u2019, an operational, autonomous, user-driven, civil Earth observation system under civil control, building on the existing national and European capacities, offering geo-information data and services, comprising satellites, ground infrastructure, data and information processing facilities, and distribution infrastructure, based on a free, full and open data policy and, where appropriate, integrating the needs and requirements of security; (d) \u2018Space Situational Awareness\u2019 or \u2018SSA\u2019, which includes the following sub-components: (i) \u2018SST sub-component\u2019, a space surveillance and tracking system aiming to improve, operate and provide data, information and services related to the surveillance and tracking of space objects that orbit the Earth; (ii) \u2018SWE sub-component\u2019, observational parameters related to space weather events; and (iii) \u2018NEO sub-component\u2019, the risk monitoring of near-Earth objects approaching the Earth; (e) \u2018GOVSATCOM\u2019, a satellite communications service under civil and governmental control enabling the provision of satellite communications capacities and services to Union and Member State authorities managing security critical missions and infrastructures. 2. The Programme shall include additional measures to ensure efficient and autonomous access to space for the Programme and to foster an innovative and competitive European space sector, upstream and downstream, to strengthen the Union\u2019s space ecosystem and to reinforce the Union as a global player. Article 4 Objectives 1. The general objectives of the Programme are to: (a) provide or contribute to the provision of high-quality and up-to-date and, where appropriate, secure space-related data, information and services without interruption and wherever possible at global level, meeting existing and future needs and able to support the Union\u2019s political priorities and related evidence-based and independent decision making, inter alia for climate change, transport and security; (b) maximise the socio-economic benefits, in particular by fostering the development of innovative and competitive European upstream and downstream sectors, including SMEs and start-ups, thereby enabling growth and job creation in the Union and promoting the widest possible uptake and use of the data, information and services provided by the Programme\u2019s components both within and outside the Union; while ensuring synergies and complementarity with the Union\u2019s research and technological development activities carried out under Regulation (EU) 2021/695; (c) enhance the safety and security of the Union and its Member States and reinforce the autonomy of the Union, in particular in terms of technology; (d) promote the role of the Union as a global actor in the space sector, encourage international cooperation, reinforce European space diplomacy including by fostering the principles of reciprocity and fair competition, and to strengthen its role in tackling global challenges, supporting global initiatives including with regard to sustainable development and raising awareness of space as a common heritage of humankind; (e) enhance the safety, security and sustainability of all outer space activities pertaining to space objects and debris proliferation, as well as space environment, by implementing appropriate measures, including development and deployment of technologies for spacecraft disposal at the end of operational lifetime and for space debris disposal. 2. The specific objectives of the Programme are: (a) for Galileo and EGNOS: to provide long-term, state-of-the-art and secure positioning, navigation and timing services whilst ensuring service continuity and robustness; (b) for Copernicus: to deliver accurate and reliable Earth observation data, information and services integrating other data sources, supplied on a long-term sustainable basis, to support the formulation, implementation and monitoring of the Union and its Member States\u2019 policies and actions based on user requirements; (c) for SSA: to enhance capabilities to monitor, track and identify space objects and space debris with the aim of further increasing the performance and autonomy of capabilities under the SST sub-component at Union level, to provide SWE services and to map and network Member States\u2019 capacities under the NEO sub-component; (d) for GOVSATCOM: to ensure the long-term availability of reliable, secure and cost-effective satellite communications services for GOVSATCOM users; (e) to support an autonomous, secure and cost-efficient capability to access space, taking into account the essential security interests of the Union; (f) to foster the development of a strong Union space economy, including by supporting the space ecosystem and by reinforcing competitiveness, innovation, entrepreneurship, skills and capacity building in all Member States and Union regions, with particular regard to SMEs and start-ups or natural and legal persons from the Union who are active or wishing to become active in that sector. Article 5 Access to space 1. The Programme shall support the procurement and aggregation of launching services for the needs of the Programme and, at their request, the aggregation for Member States and international organisations. 2. In synergies with other Union programmes and funding schemes, and without prejudice to ESA\u2019s activities in the area of access to space, the Programme may support: (a) adaptations, including technology development, to space launch systems which are necessary for launching satellites, including alternative technologies and innovative systems on access to space, for the implementation of the Programme\u2019s components; (b) adaptations to the space ground infrastructure, including new developments, which are necessary for the implementation of the Programme. Article 6 Actions in support of an innovative and competitive Union space sector 1. The Programme shall promote capacity building across the Union, by supporting: (a) innovation activities for making best use of space technologies, infrastructure or services and measures to facilitate the uptake of innovative solutions resulting from research and innovation activities and to support the development of the downstream sector, in particular through synergies with other Union programmes and financial instruments, including the InvestEU Programme; (b) activities aiming to foster public demand and public sector innovation, to realise the full potential of public services for citizens and businesses; (c) entrepreneurship, including from early stage to scaling-up, in accordance with Article 21, by relying on other provisions on access to finance as referred to in Article 18 and Chapter I of Title III, and by using a first contract approach; (d) the emergence of a business-friendly space ecosystem through cooperation amongst undertakings in the form of a network of space hubs which: (i) bring together, at national and regional levels, actors from the space, digital and other sectors, as well as users; and (ii) aim to provide support, facilities and services to citizens and companies to foster entrepreneurship and skills, to enhance synergies in the downstream sector and to foster cooperation with the digital innovation hubs established under the Digital Europe Programme established by Regulation (EU) 2021/694 of the European Parliament and of the Council (38); (e) the provision of education and training activities, in particular for professionals, entrepreneurs, graduates and students, notably through synergies with initiatives at national and regional levels, for the development of advanced skills; (f) access to processing and testing facilities for private and public sector professionals, students and entrepreneurs; (g) certification and standardisation activities; (h) the reinforcement of European supply chains across the Union through wide participation of enterprises, in particular SMEs and start-ups, in all the Programme\u2019s components, particularly through Article 14, and of measures to underpin their competitiveness at global level. 2. When implementing activities referred to in paragraph 1, the need to develop capacity in Member States with an emerging space industry shall be supported, in order to provide an equal opportunity to all Member States to participate in the Programme. Article 7 Participation of third countries and international organisations in the Programme 1. Galileo, EGNOS and Copernicus, as well as the SWE and NEO sub-components, but excluding the SST sub-component, shall be open to the participation of the members of the European Free Trade Association (EFTA) which are members of the European Economic Area (EEA), in accordance with the conditions laid down in the Agreement on the European Economic Area. Copernicus and the SWE and NEO sub-components, but excluding the SST sub-component, shall be open to the participation of the following third countries: (a) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries; (b) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries. 2. In accordance with the conditions laid down in a specific agreement concluded in accordance with Article 218 TFEU covering the participation of a third country or of an international organisation to any Union programme: (a) Galileo and EGNOS shall be open to the participation of third countries referred to in points (a) and (b) of the second subparagraph of paragraph 1; (b) GOVSATCOM shall be open to the participation of members of EFTA which are members of the EEA, as well as of third countries referred to in points (a) and (b) of the second subparagraph of paragraph 1; and (c) Galileo, EGNOS, Copernicus, GOVSATCOM, as well as the SWE and NEO sub-components, but excluding the SST sub-component, shall be open to the participation of third countries, other than those third countries covered by paragraph 1, and international organisations. The specific agreement referred to in the first subparagraph of this paragraph shall: (a) ensure a fair balance as regards the contributions and benefits of the third country or international organisation participating in the Union programmes; (b) lay down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (c) not confer on the third country or international organisation any decision-making power in respect of the Union programme; (d) guarantee the rights of the Union to ensure sound financial management and to protect its financial interests. The contributions referred to in point (b) of the second subparagraph of this paragraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. 3. The Programme\u2019s components or sub-components, excluding the SST sub-component, shall only be open to the participation of third countries and international organisations under this Article provided that the essential security interests of the Union and its Member States are preserved, including as regards the protection of classified information under Article 43. Article 8 Access to SST services, GOVSATCOM services and the Galileo Public Regulated Service by third countries and international organisations 1. Third countries and international organisations may have access to GOVSATCOM services provided that: (a) they conclude an agreement, in accordance with Article 218 TFEU, laying down the terms and conditions for access to GOVSATCOM services; and (b) they comply with Article 43 of this Regulation. 2. Third countries and international organisations not having their headquarters in the Union may have access to SST services referred to in point (d) of Article 55(1) provided that: (a) they conclude an agreement, in accordance with Article 218 TFEU, laying down the terms and conditions for access to such SST services; and (b) they comply with Article 43 of this Regulation. 3. No agreement concluded in accordance with Article 218 TFEU shall be required to access SST services which are publicly available, as referred to in points (a), (b) and (c) of Article 55(1). Access to those services shall be subject to a request from the potential users in accordance with Article 56. 4. The access of third countries and international organisations to the Public Regulated Service (PRS) provided by Galileo shall be governed by Article 3(5) of Decision No 1104/2011/EU of the European Parliament and of the Council (39). Article 9 Ownership and use of assets 1. Except as provided under paragraph 2, the Union shall be the owner of all tangible and intangible assets created or developed under the Programme\u2019s components. To that effect, the Commission shall ensure that relevant contracts, agreements and other arrangements relating to the activities which may result in the creation or development of such assets contain provisions ensuring the Union\u2019s ownership of those assets. 2. Paragraph 1 does not apply to the tangible and intangible assets created or developed under the Programme\u2019s components, where the activities which may result in the creation or development of such assets: (a) are carried out pursuant to grants or prizes fully financed by the Union; (b) are not fully financed by the Union; or (c) relate to the development, manufacture or use of PRS receivers incorporating EUCI, or components of such receivers. 3. The Commission shall ensure that the contracts, agreements and other arrangements relating to the activities referred to in paragraph 2 of this Article contain provisions setting out the appropriate ownership regime for those assets and, as regards point (c) of paragraph 2 of this Article, that they ensure that the Union can use the PRS receivers in accordance with Decision No 1104/2011/EU. 4. The Commission shall seek to conclude contracts, agreements or other arrangements with third parties with regard to: (a) pre-existing ownership rights in respect of tangible and intangible assets created or developed under the Programme\u2019s components; (b) the acquisition of the ownership or license rights in respect of other tangible and intangible assets necessary for the implementation of the Programme. 5. The Commission shall ensure, by means of an appropriate framework, the optimal use of the tangible and intangible assets referred to in paragraphs 1 and 2 owned by the Union. 6. Where the assets referred to in paragraphs 1 and 2 consist of intellectual property rights, the Commission shall manage those rights as effectively as possible, taking account of: (a) the need to protect and give value to the assets; (b) the legitimate interests of all stakeholders concerned; (c) the need for harmonious development of markets and new technologies; and (d) the need for the continuity of the services provided by the Programme's components. The Commission shall ensure in particular that the relevant contracts, agreements and other arrangements include the possibility of transferring those intellectual property rights to third parties or of granting third-party licences for those rights, including to the creator of the intellectual property, and that the Agency can freely enjoy those rights where necessary for carrying out its tasks under this Regulation. The FFPA provided for in Article 28(4) or the contribution agreements referred to in Article 32(1) shall contain relevant provisions to allow the use of the intellectual property rights referred to in the first subparagraph of this paragraph by ESA and the other entrusted entities where necessary to perform their tasks under this Regulation, and the conditions for that use. Article 10 Warranty 1. Without prejudice to the obligations imposed by legally binding provisions, the services, data and information provided by the Programme\u2019s components shall be provided without any express or implied warranty as regards their quality, accuracy, availability, reliability, speed and suitability for any purpose. 2. The Commission shall ensure that the users of those services, data and information are duly informed of paragraph 1. TITLE II BUDGETARY CONTRIBUTION AND MECHANISMS Article 11 Budget 1. The financial envelope for the implementation of the Programme for the period from 1 January 2021 to 31 December 2027 and for covering the associated risks shall be EUR 14,880 billion in current prices. The distribution of the amount referred to in the first subparagraph shall be broken down in the following categories of expenditure: (a) for Galileo and EGNOS: EUR 9,017 billion; (b) for Copernicus: EUR 5,421 billion; (c) for SSA and GOVSATCOM: EUR 0,442 billion. 2. The Commission may reallocate funds between the categories of expenditure referred to in paragraph 1 of this Article, up to a ceiling of 7,5 % of the category of expenditure that receives the funds or the category that provides the funds. The Commission may, by means of implementing acts, reallocate funds between the categories of expenditure referred to in paragraph 1 of this Article when that reallocation exceeds a cumulative amount greater than 7,5 % of the amount allocated to the category of expenditure that receives the funds or the category that provides the funds. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 3. Additional measures as provided for in Article 3(2), namely activities referred to in Articles 5 and 6, shall be financed under the Programme\u2019s components. 4. The Union budget appropriations assigned to the Programme shall cover all the activities required to fulfil the objectives referred to in Article 4. Such expenditure may cover: (a) studies and meetings of experts, in particular compliance with its cost and time constraints; (b) information and communication activities, including corporate communication on the policy priorities of the Union where they are directly linked to the objectives of this Regulation, with a particular view to creating synergies with other Union policies; (c) the information technology networks whose function it is to process or exchange information, and the administrative management measures, including in the field of security, implemented by the Commission; (d) technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems. 5. Actions that receive cumulative funding from different Union programmes shall be audited only once, covering all involved programmes and their respective applicable rules. 6. The budgetary commitments relating to the Programme and which cover activities extending over more than one financial year may be broken down over several years into annual instalments. 7. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme, subject to the conditions set out in Article 26 of the Common Provisions Regulation. The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. Article 12 Assigned revenue 1. The revenue generated by the Programme\u2019s components shall be paid into the Union budget and used to finance the component which generated the revenue. 2. The Member States may endow a component of the Programme with an additional financial contribution to cover additional elements, on condition that such additional elements do not create any financial or technical burden or any delay for the component concerned. The Commission shall, by means of implementing acts, decide whether those conditions have been met. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 3. The additional financial contribution referred to in this Article shall be treated as external assigned revenue in accordance with Article 21(2) of the Financial Regulation. Article 13 Implementation and forms of Union funding 1. The Programme shall be implemented under direct management in accordance with the Financial Regulation or under indirect management with bodies referred to in point (c) of the first subparagraph of Article 62(1) of the Financial Regulation. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular grants, prizes and procurement. It may also provide financing in the form of financial instruments within blending operations. 3. Where the Copernicus budget is implemented under indirect management, the procurement rules of the entities entrusted with budget implementation tasks may apply to the extent allowed under Articles 62 and 154 of the Financial Regulation. Specific adjustments necessary to those procurement rules shall be defined in the relevant contribution agreements. TITLE III FINANCIAL PROVISIONS CHAPTER I Procurement Article 14 Principles of procurement 1. In procurement procedures for the purpose of the Programme, the contracting authority shall act in accordance with the following principles: (a) to promote in all Member States throughout the Union and throughout the supply chain, the widest and most open participation possible by economic operators, in particular start-ups, new entrants and SMEs, including in the case of sub-contracting by the tenderers; (b) to ensure effective competition and, where possible, to avoid reliance on a single provider, in particular for critical equipment and services, while taking into account the objectives of technological independence and continuity of services; (c) by way of derogation from Article 167 of the Financial Regulation, to use, wherever appropriate, multiple supply sources in order to ensure better overall control of all the Programme\u2019s components, their cost and schedule; (d) to follow the principles of open access and fair competition throughout the industrial supply chain, by tendering on the basis of the provision of transparent and timely information, clear communication of the applicable procurement rules and procedures, selection and award criteria and any other relevant information allowing a level-playing field for all potential tenderers, including SMEs and start-ups; (e) to reinforce the autonomy of the Union, in particular in technological terms; (f) to comply with the security requirements of the Programme\u2019s components and to contribute to the protection of the essential security interests of the Union and its Member States; (g) to promote service continuity and reliability; (h) to satisfy appropriate social and environmental criteria. 2. The procurement board, within the Commission, shall scrutinise the procurement process related to all of the Programme\u2019s components and monitor the contractual implementation of the Union budget delegated to entrusted entities. A representative of each of the entrusted entities shall be invited where appropriate. Article 15 Conditional stage-payment contracts 1. With regard to operational and infrastructure-specific activities, the contracting authority may award a contract in the form of a conditional stage-payment contract in accordance with this Article. 2. The procurement documents for a conditional stage-payment contract shall refer to the specific features of conditional stage-payment contracts. In particular, they shall specify the subject-matter of the contract, the price or the arrangements for determining the price and the arrangements for the provision of works, supplies and services at each stage. 3. A conditional stage-payment contract shall include: (a) a fixed stage which results in a firm commitment to provide the works, supplies or services contracted for that stage; and (b) one or more stages, which are conditional in terms of both budget and execution. 4. The obligations under the fixed stage and the obligations under each conditional stage shall be part of a consistent whole, taking into account the obligations under the previous or subsequent stages. 5. Performance of each conditional stage shall be subject to a decision by the contracting authority, notified to the contractor in accordance with the contract. Article 16 Cost-reimbursement contracts 1. The contracting authority may opt for a full or partial cost-reimbursement contract under the conditions laid down in paragraph 3. 2. The price to be paid under a cost-reimbursement contract shall consist of the reimbursement of: (a) all direct costs actually incurred by the contractor in performing the contract, such as expenditure on labour, materials, consumables and use of the equipment and infrastructures necessary to perform the contract; (b) indirect costs; (c) a fixed profit; and (d) an appropriate incentive fee based on achieving objectives in respect of performance and delivery schedules. 3. The contracting authority may opt for a full or partial cost-reimbursement contract in cases where it is difficult or unsuitable to provide an accurate fixed price due to the uncertainties inherent in the performance of the contract because: (a) the contract has very complex features or features which require the use of a new technology and, therefore, includes a significant number of technical risks; or (b) the activities subject to the contract must, for operational reasons, start immediately even though it is not yet possible to determine an accurate fixed price in full due to significant risks or because the performance of the contract depends in part on the performance of other contracts. 4. Cost-reimbursement contracts shall stipulate a maximum ceiling price. The maximum ceiling price for a full or partial cost-reimbursement contract shall be the maximum price payable. The price may be modified in accordance with Article 172 of the Financial Regulation. Article 17 Subcontracting 1. To encourage new entrants, SMEs and start-ups and their cross-border participation, and to offer the widest possible geographical coverage while protecting the Union\u2019s autonomy, the contracting authority shall request that the tenderer subcontracts part of the contract by competitive tendering at the appropriate levels of subcontracting to companies other than those which belong to the tenderer\u2019s group. 2. The tenderer shall justify any derogation from a request made under paragraph 1. 3. For contracts above EUR 10 million, the contracting authority shall aim to ensure that at least 30 % of the value of the contract is subcontracted by competitive tendering at various levels of subcontracting to companies outside the group of the prime tenderer, particularly in order to enable the cross-border participation of SMEs. The Commission shall inform the Programme committee referred to in Article 107(1) on the fulfilment of that objective for contracts signed after the entry into force of this Regulation. CHAPTER II Grants, prizes and blending operations Article 18 Grants and prizes 1. The Union may cover up to 100 % of the eligible costs, without prejudice to the co-financing principle. 2. By way of derogation from Article 181(6) of the Financial Regulation when applying flat rates, the authorising officer responsible may authorise or impose funding of the beneficiary\u2019s indirect costs up to a maximum of 25 % of total eligible direct costs for the action. 3. Notwithstanding paragraph 2 of this Article, indirect costs may be declared in the form of a lump sum or unit costs when provided for in the work programme referred to in Article 100. 4. By way of derogation from Article 204 of the Financial Regulation, the maximum amount of financial support that can be paid to a third party shall not exceed EUR 200 000. Article 19 Joint calls for grants 1. The Commission or an entrusted entity in the context of the Programme may issue a joint call for proposals with entities, bodies or persons referred to in point (c) of the first subparagraph of Article 62(1) of the Financial Regulation. 2. In the case of a joint call referred to in paragraph 1 of this Article: (a) the rules referred to in Title VIII of the Financial Regulation shall apply; (b) the evaluation procedures shall involve a balanced group of experts appointed by each party; and (c) the evaluation committees shall comply with Article 150 of the Financial Regulation. 3. The grant agreement shall specify the arrangement applicable to intellectual property rights. Article 20 Grants for pre-commercial procurement and procurement of innovative solutions 1. Actions may involve or have as their primary aim pre-commercial procurement or public procurement of innovative solutions that shall be carried out by beneficiaries which are contracting authorities or contracting entities as defined in Directives 2014/24/EU (40), 2014/25/EU (41) and 2009/81/EC (42) of the European Parliament and of the Council. 2. The procurement procedures for innovative solutions: (a) shall comply with the principles of transparency, non-discrimination, equal treatment, sound financial management, proportionality and competition rules; (b) in the case of pre-commercial procurement, may provide for specific conditions such as the place of performance of the procured activities being limited to the territory of the Member States and of the third countries participating in the Programme; (c) may authorise the award of multiple contracts within the same procedure (multiple sourcing); and (d) shall provide for the award of the contracts to the tender(s) offering best value for money while ensuring the absence of conflicts of interest. 3. The contractor generating results in pre-commercial procurement shall own at least the intellectual property rights attached to the results. The contracting authorities shall enjoy at least royalty-free access rights to the results for their own use and the right to grant, or require the contractor to grant, non-exclusive licences to third parties to exploit the results for the contracting authority under fair and reasonable conditions without any right to sub-licence. If a contractor fails to commercially exploit the results within a given period after the pre-commercial procurement as identified in the contract, the contracting authorities may require it to transfer any ownership of the results to the contracting authorities. Article 21 Blending operations Blending operations decided under the Programme shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. CHAPTER III Other financial provisions Article 22 Cumulative and alternative funding 1. An action that has received a contribution under the Programme may also receive a contribution from another Union programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 2. Actions awarded a Seal of Excellence label under the Programme may receive support from the European Regional Development Fund or the European Social Fund Plus, in accordance with Article 73(4) of the Common Provisions Regulation, if they comply with the following cumulative conditions: (a) they have been assessed in a call for proposals under the Programme; (b) they comply with the minimum quality requirements of that call for proposals; (c) they cannot be financed under that call for proposals due to budgetary constraints. Article 23 Joint procurement 1. In addition to the provisions of Article 165 of the Financial Regulation, the Commission or the Agency may carry out joint procurement procedures with ESA or other international organisations involved in implementing the Programme\u2019s components. 2. The procurement rules applicable under Article 165 of the Financial Regulation shall apply by analogy provided that in any case the procedural provisions applicable to the Union institutions are applied. Article 24 Eligibility and participation conditions for the preservation of the security, integrity and resilience of operational systems of the Union 1. The Commission shall apply the eligibility and participation conditions set out in paragraph 2 to the procurement, grants or prizes under this Title if it deems that this is necessary and appropriate to preserve the security, integrity and resilience of the operational Union systems, taking into account the objective to promote the Union's strategic autonomy, in particular in terms of technology across key technologies and value chains, while preserving an open economy. Before applying the eligibility and participation conditions in accordance with the first subparagraph of this paragraph the Commission shall inform the Programme committee referred to in point (e) of Article 107(1) and shall take utmost account of the Member States\u2019 views on the scope of application of and the justification for those eligibility and participation conditions. 2. The eligibility and participation conditions shall be as follows: (a) the eligible legal entity is established in a Member State and its executive management structures are established in that Member State; (b) the eligible legal entity commits to carry out all relevant activities in one or more Member States; and (c) the eligible legal entity is not to be subject to control by a third country or by a third country entity. For the purpose of this Article, \u2018control\u2019 means the ability to exercise a decisive influence over a legal entity directly, or indirectly through one or more intermediate legal entities. For the purpose of this Article, \u2018executive management structure\u2019 means the body of a legal entity appointed in accordance with national law, and which, where applicable, reports to the chief executive officer or any other person having comparable decisional power, and which is empowered to establish the legal entity\u2019s strategy, objectives and overall direction, and oversees and monitors management decision-making. 3. The Commission may waive the conditions under points (a) or (b) of the first subparagraph of paragraph 2 for a particular legal entity upon evaluation based on the following cumulative criteria: (a) for specific technologies, goods or services needed for the activities referred to in paragraph 1 no substitutes are readily available in the Member States; (b) the legal entity is established in a country which is a member of the EEA or EFTA and which has concluded an international agreement with the Union as referred to in Article 7, its executive management structures are established in that country and the activities linked to the procurement, grant or prize are carried out in that country or in one or more such countries; and (c) sufficient measures are implemented to ensure the protection of EUCI under Article 43 and the integrity, security and resilience of the Programme\u2019s components, their operation and their services. By way of derogation from point (b) of the first subparagraph of this paragraph, the Commission may waive the conditions under points (a) or (b) of the first subparagraph of paragraph 2 for a legal entity established in a third country which is not a member of the EEA or EFTA if no substitutes are readily available in countries which are members of the EEA or EFTA and the criteria set out in points (a) and (c) of the first subparagraph are met. 4. The Commission may waive the condition under point (c) of the first subparagraph of paragraph 2 if the legal entity established in a Member State provides the following guarantees: (a) control over the legal entity is not exercised in a manner that restrains or restricts its ability to: (i) carry out the procurement, grant or prize; and (ii) deliver results, in particular through reporting obligations; (b) the controlling third country or third country entity commits to refrain from exercising any controlling rights over or imposing reporting obligations on the legal entity in relation to the procurement, grant or prize; and (c) the legal entity complies with Article 34(7). 5. The competent authorities of the Member State in which the legal entity is established shall assess whether the legal entity complies with the criteria set out in point (c) of paragraph 3 and guarantees referred to in paragraph 4. The Commission shall comply with that assessment. 6. The Commission shall provide the following to the Programme committee referred to in point (e) of Article 107(1): (a) the scope of application of eligibility and participation conditions referred to in paragraph 1 of this Article; (b) details and justifications on the waivers granted in accordance with this Article; and (c) the evaluation that formed the basis for a waiver, subject to paragraphs 3 and 4 of this Article, without divulging commercially sensitive information. 7. The conditions set out in paragraph 2, the criteria set out in paragraph 3 and the guarantees set out in paragraph 4 shall be included in the documents relating to the procurement, grant or prize, as applicable, and, in the case of procurement, they shall apply to the full life cycle of the resulting contract. 8. This Article is without prejudice to Decision No 1104/2011/EU and Commission Delegated Decision of 15.9.2015 (43), Regulation (EU) 2019/452, Decision 2013/488/EU and Decision (EU, Euratom) 2015/444 and to the security vetting carried out by Member States with regard to legal entities involved in activities requiring access to EUCI subject to the applicable national laws and regulations. If contracts resulting from the application of this Article are classified, eligibility and participation conditions applied by the Commission in accordance with paragraph 1 shall be without prejudice to the competence of national security authorities. This Article shall not interfere with, amend or contradict any existing Facility Security Clearance and Personnel Security Clearance procedure within a Member State. Article 25 Protection of the financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. TITLE IV GOVERNANCE OF THE PROGRAMME Article 26 Principles of governance The governance of the Programme shall be based on the following principles: (a) clear distribution of tasks and responsibilities between the entities involved in the implementation of each of the Programme\u2019s components and measures, in particular between the Member States, the Commission, the Agency, ESA and EUMETSAT, building on their respective competences and avoiding any overlap in tasks and responsibilities; (b) relevance of the governance structure to the specific needs of each of the Programme\u2019s components and measures, as appropriate; (c) strong control of the Programme, including strict adherence to cost, schedule and performance by all the entities, within their respective roles and tasks in accordance with this Regulation; (d) transparent and cost-efficient management; (e) service continuity and necessary infrastructure continuity, including protection from relevant threats; (f) systematic and structured consideration of the needs of users of the data, information and services provided by the Programme\u2019s components, as well as of related scientific and technological evolutions; (g) constant efforts to control and reduce risks. Article 27 Role of the Member States 1. The Member States may participate in the Programme. Member States which participate in the Programme shall contribute with their technical competence, know-how and assistance, in particular in the field of safety and security, or, where appropriate and possible, by making available to the Union the data, information, services and infrastructure in their possession or located on their territory, including by ensuring an efficient and obstacle free access and use of Copernicus in-situ data and cooperating with the Commission to improve the availability of Copernicus in-situ data required by the Programme, taking into account applicable licences and obligations. 2. The Commission may entrust, by means of contribution agreements, specific tasks to Member State organisations, where such organisations have been designated by the Member State concerned. The Commission shall adopt the contribution decisions regarding the contribution agreements by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2). 3. In certain duly justified circumstances, for the tasks referred to in Article 29 the Agency may entrust, by means of contribution agreements, specific tasks to Member State organisations, where such organisations have been designated by the Member State concerned. 4. The Member States shall take all the necessary measures to ensure the smooth functioning of the Programme, including by helping to protect, at the appropriate level, the frequencies required for the Programme. 5. The Member States and the Commission may cooperate to widen the uptake of data, information and services provided by the Programme\u2019s components. 6. Whenever possible, the contribution of Member States to the User Forum referred to in Article 107(6) shall be based on a systematic and coordinated consultation of end user communities at national level, in particular regarding Galileo, EGNOS and Copernicus. 7. The Member States and the Commission shall cooperate in order to develop the in-situ component of Copernicus and ground calibration services necessary for the uptake of space systems and to facilitate the use of Copernicus in-situ data and reference data sets to their full potential, building on existing capacities. 8. In the field of security, the Member States shall perform the tasks referred to in Article 34(6). Article 28 Role of the Commission 1. The Commission shall have overall responsibility for the implementation of the Programme, including in the field of security, without prejudice to Member States\u2019 prerogatives in the area of national security. The Commission shall, in accordance with this Regulation, determine the priorities and long-term evolution of the Programme, in line with the user requirements, and shall supervise its implementation, without prejudice to other policies of the Union. 2. The Commission shall manage any of the Programme\u2019s components or sub-components not entrusted to another entity, in particular GOVSATCOM, NEO sub-component, SWE sub-component and the activities referred to in point (d) of Article 55(1). 3. The Commission shall ensure a clear division of tasks and responsibilities between the various entities involved in the Programme and shall coordinate the activities of those entities. The Commission shall also ensure that all the entrusted entities involved in the implementation of the Programme protect the interest of the Union, guarantee the sound management of the Union\u2019s funds and comply with the Financial Regulation and this Regulation. 4. The Commission shall conclude with the Agency and, taking into account the 2004 Framework Agreement, ESA, an FFPA as provided for in Article 130 of the Financial Regulation. 5. Where necessary for the smooth functioning of the Programme and the smooth provision of the services provided by the Programme\u2019s components, the Commission shall, by means of implementing acts, determine the technical and operational requirements needed for the implementation of and evolution of those components and of the services they provide after having consulted users, including through the User Forum referred to in Article 107(6), and other stakeholders. When determining those technical and operational requirements, the Commission shall avoid reducing the general security level and shall imperatively meet backwards compatibility requirements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 6. Without prejudice to the tasks of the Agency or of other entrusted entities, the Commission shall ensure that the uptake and use of the data and services provided by the Programme\u2019s components is promoted and maximised in the public and private sectors, including by supporting appropriate development of those services and user-friendly interfaces, and by fostering a stable long-term environment. It shall develop appropriate synergies between the applications of the Programme\u2019s various components. It shall ensure complementarity, consistency, synergies and links between the Programme and other Union actions and programmes. 7. Where appropriate, the Commission shall ensure the coherence of activities performed in the context of the Programme with activities carried out in the space domain at Union, national or international level. It shall encourage cooperation between the Member States and, when relevant to the Programme, facilitate convergence of their technological capacities and developments in the space domain. To that end, the Commission shall, where appropriate and in their respective field of competence, cooperate with the Agency and ESA. 8. The Commission shall inform the Programme committee referred to in Article 107 of the interim and final results of the evaluation of any procurement procedures and of any contracts, including subcontracts, with public and private entities. Article 29 Role of the Agency 1. The Agency shall have the following own tasks: (a) to ensure, through its Security Accreditation Board, the security accreditation of all the Programme\u2019s components in accordance with Chapter II of Title V; (b) to perform tasks referred to in Article 34(3) and (5); (c) to undertake communication, market development and promotion activities as regards the services offered by Galileo and EGNOS, in particular activities relating to the market uptake and coordination of user needs; (d) to undertake communication, market development and promotion activities as regards data, information and services offered by Copernicus, without prejudice to the activities performed by other entrusted entities and the Commission; (e) to provide expertise to the Commission, including for the preparation of the downstream space-related research priorities. 2. The Commission shall entrust the following tasks to the Agency: (a) managing the exploitation of EGNOS and Galileo, as provided for in Article 44; (b) overarching coordination of user-related aspects of GOVSATCOM in close collaboration with Member States, relevant Union agencies, EEAS and other entities for the purpose of crisis management missions and operations; (c) implementing activities relating to the development of downstream applications based on the Programme\u2019s components and fundamental elements and integrated applications based on the data and services provided by Galileo, EGNOS and Copernicus, including where funding has been made available for such activities in the context of the Horizon Europe or where necessary to fulfil the objectives referred to in point (b) of Article 4(1); (d) undertaking activities related to user uptake of data, information and services, offered by the Programme\u2019s components other than Galileo and EGNOS; without affecting Copernicus activities and Copernicus Services entrusted to other entities; (e) specific actions referred to in Article 6. 3. The Commission may, on the basis of the assessments referred to in Article 102(5), entrust other tasks to the Agency, provided that they do not duplicate activities performed by other entrusted entities in the context of the Programme and provided that they aim to improve the efficiency of the implementation of the Programme\u2019s activities. 4. Whenever activities are entrusted to the Agency, appropriate financial, human and administrative resources shall be ensured for their implementation. 5. By way of derogation from Article 62(1) of the Financial Regulation and subject to the Commission\u2019s assessment of the protection of the Union\u2019s interests, the Agency may entrust, by means of contribution agreements, specific activities to other entities, in areas of their respective competence, under the conditions of indirect management applying to the Commission. Article 30 Role of ESA 1. Provided that the interest of the Union is protected, ESA shall be entrusted with the following tasks: (a) as regards Copernicus: (i) coordination of the space component and of the implementation of the space component and its evolution; (ii) design, development and construction of the Copernicus space infrastructure, including the operations of that infrastructure and related procurement, except when those operations are done by other entities; and (iii) where appropriate, provision of access to third party data; (b) as regards Galileo and EGNOS: systems evolution and design and development of parts of the ground segment, and of satellites, including testing and validation; (c) as regards all of the Programme\u2019s components: upstream research and development activities in ESA\u2019s fields of expertise. 2. On the basis of an assessment by the Commission, ESA may be entrusted with other tasks based of the needs of the Programme, provided that those tasks do not duplicate activities performed by another entrusted entity in the context of the Programme and that they aim to improve the efficiency of the implementation of the Programme\u2019s activities. 3. Without prejudice to the FFPA provided for in Article 31, the Commission or the Agency may request ESA to provide technical expertise and the information necessary to perform the tasks which are assigned to them by this Regulation under conditions to be mutually agreed. Article 31 The financial framework partnership agreement 1. The FFPA referred to in Article 28(4) shall: (a) clearly define the roles, responsibilities and obligations of the Commission, the Agency and ESA with regard to each of the Programme\u2019s components and necessary coordination and control mechanisms; (b) require that ESA applies the Union security rules defined in the security agreements concluded between the Union, and its institutions and agencies, with ESA, in particular with regard to the processing of classified information; (c) stipulate the conditions of the management of funds entrusted to ESA, particularly with regard to public procurement, including the application of Union procurement rules when procuring in the name and on behalf of the Union or the application of the rules of the entrusted entity in accordance with Article 154 of the Financial Regulation, management procedures, the expected results measured by performance indicators, applicable measures in the event of deficient or fraudulent implementation of the contracts in terms of costs, schedule and results, as well as the communication strategy and the rules regarding ownership of all tangible and intangible assets; those conditions shall be in conformity with Titles III and V of this Regulation and with the Financial Regulation; (d) require that, whenever a Tender Evaluation Board is established by the Agency or ESA for a procurement performed under the FFPA, experts from the Commission and, where relevant, from the other entrusted entity shall participate as members in the Tender Evaluation Board meetings. Such participation shall not affect the technical independence of the Tender Evaluation Board; (e) establish the monitoring and control measures, which shall include, in particular: (i) a cost forecast system; (ii) the systematic provision of information to the Commission or, where appropriate, to the Agency, on costs and schedule; and (iii) in the event of a discrepancy between the planned budgets, performance and schedule, corrective action ensuring performance of the tasks within the allocated budgets; (f) establish the principles for the remuneration of ESA for each of the Programme\u2019s components, which shall be commensurate with the conditions under which the actions are implemented, taking due account of situations of crisis and fragility and which, where appropriate, shall be performance based; the remuneration shall only cover general overheads which are associated with the activities entrusted to ESA by the Union; (g) provide that ESA takes appropriate measures to ensure the protection of the interests of the Union and to comply with the decisions taken by the Commission for each of the Programme\u2019s components in application of this Regulation. 2. The Commission shall, by means of implementing acts, decide on the FFPA. Those implementing acts shall be adopted in accordance with the examination procedure referred in Article 107(3). The European Parliament and the Council shall be fully informed about the FFPA well in advance of its conclusion and about its implementation. 3. Under the FFPA referred to in paragraph 1 of this Article, the tasks referred to in Article 29(2) and (3) shall be entrusted to the Agency and the tasks referred to in Article 30(1) shall be entrusted to ESA, by means of contribution agreements. The Commission shall, by means of implementing acts, adopt the contribution decision regarding the contribution agreements. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2). The European Parliament and the Council shall be fully informed about the contribution agreements well in advance of their conclusion and about their implementation. Article 32 Role of EUMETSAT and other entities 1. The Commission may entrust, in full or in part, by means of contribution agreements, the implementation of the following tasks to entities other than those referred to in Articles 29 and 30: (a) the upgrading, operations preparation and operation of the Copernicus space infrastructure or parts thereof and, where appropriate, management of access to contributing mission data, which may be entrusted to EUMETSAT; (b) the implementation of the Copernicus Services or parts thereof to relevant agencies, bodies or organisations, such as the European Environment Agency, Frontex, the European Maritime Safety Agency, the SATCEN and the European Centre for Medium-Range Weather Forecasts; the tasks entrusted to those agencies, bodies or organisations shall be performed in sites located in the Union; an agency, body or organisation, already in the process of relocating its entrusted tasks to the Union, may continue to perform those tasks in a location outside the Union for a limited period, ending at the latest by 31 December 2023. 2. The criteria for the selection of such entrusted entities shall, in particular, reflect their ability to ensure the continuity and, where appropriate, the security of the operations with no disruption of the Programme\u2019s activities. 3. Whenever possible, the conditions of the contribution agreements referred to in paragraph 1 of this Article shall be coherent with the conditions of the FFPA referred to in Article 31(1). 4. The Programme committee shall be consulted on the contribution decision regarding the contribution agreement referred to in paragraph 1 of this Article in accordance with the advisory procedure referred to in Article 107(2). The Programme committee shall be informed in advance of the contribution agreements to be concluded by the Union, represented by the Commission and the entities referred to in paragraph 1 of this Article. TITLE V SECURITY OF THE PROGRAMME CHAPTER I Security of the Programme Article 33 Principles of security The security of the Programme shall be based on the following principles: (a) to take account of the experience of the Member States in the field of security and draw inspiration from their best practices; (b) to use the security rules of the Council and of the Commission, which provide, inter alia, for a separation between operational functions and those associated with accreditation. Article 34 Governance of security 1. The Commission shall, in its field of competence and with the support of the Agency, ensure a high degree of security with regard, in particular, to: (a) the protection of infrastructure, both ground and space, and of the provision of services, particularly against physical or cyber-attacks, including interference with data streams; (b) the control and management of technology transfers; (c) the development and preservation within the Union of the competences and know-how acquired; (d) the protection of sensitive non-classified information and classified information. 2. For the purpose of paragraph 1 of this Article, the Commission shall ensure that a risk and threat analysis is performed for each of the Programme\u2019s components. Based on that analysis, it shall determine by the end of 2023, by means of implementing acts, for each of the Programme\u2019s components, the general security requirements. In doing so, the Commission shall take account of the impact of those requirements on the smooth functioning of that component, in particular in terms of cost, risk management and schedule, and shall ensure that the general level of security is not reduced and that the functioning of the existing equipment based on that component is not undermined and shall take into account cybersecurity risks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). After the entry into force of this Regulation, the Commission shall communicate an indicative list of implementing acts to be submitted to and discussed by the Programme committee in security configuration. That list shall be accompanied by an indicative timetable for submission of those implementing acts. 3. The entity responsible for the management of a component of the Programme shall be responsible for the operational security of that component and shall, to that end, carry out risk and threat analysis and all the necessary activities to ensure and monitor the security of that component, in particular setting of technical specifications and operational procedures, and monitor their compliance with the general security requirements referred to in paragraph 2 of this Article. Pursuant to Article 29, for Galileo and EGNOS that entity shall be the Agency. 4. Based on the risk and threat analysis, the Commission shall, where appropriate, identify a structure to monitor security and to follow the instructions developed under the scope of Decision (CFSP) 2021/698. The structure shall operate in accordance with the security requirements referred to in paragraph 2. For Galileo, that structure shall be the Galileo Security Monitoring Centre. 5. The Agency shall: (a) ensure the security accreditation of all the Programme\u2019s components in accordance with Chapter II of this Title and without prejudice to the competences of the Member States; (b) ensure the operation of the Galileo Security Monitoring Centre in accordance with the requirements referred to in paragraph 2 of this Article and the instructions developed under the scope of Decision (CFSP) 2021/698; (c) perform the tasks assigned to it under Decision No 1104/2011/EU; (d) provide the Commission with its technical expertise and supply any information necessary for the performance of its tasks under this Regulation. 6. To ensure the protection of the ground infrastructures which form an integral part of the Programme and which are located on their territory the Member States shall: (a) take measures which are at least equivalent to those necessary for: (i) the protection of European critical infrastructures within the meaning of Council Directive 2008/114/EC (44); and (ii) the protection of their own national critical infrastructures; (b) perform the security accreditation tasks referred to in Article 42 of this Regulation. 7. The entities involved in the Programme shall take all the necessary measures, including in light of the issues identified in the risk analysis, to ensure the security of the Programme. Article 35 Security of systems and services deployed Whenever the security of the Union or its Member States may be affected by the operation of the systems, the procedures set out in Decision (CFSP) 2021/698 shall apply. CHAPTER II Security accreditation Article 36 Security Accreditation Authority The Security Accreditation Board established within the Agency shall be the security accreditation authority for all of the Programme\u2019s components. Article 37 General principles of security accreditation Security accreditation activities for all of the Programme\u2019s components shall be conducted in accordance with the following principles: (a) security accreditation activities and decisions shall be undertaken in a context of collective responsibility for the security of the Union and of the Member States; (b) efforts shall be made for decisions within the Security Accreditation Board to be reached by consensus; (c) security accreditation activities shall be carried out using a risk assessment and management approach, considering risks to the security of the component concerned as well as the impact on cost or schedule of any measure to mitigate the risks, taking into account the objective not to lower the general level of security of that component; (d) decisions of the Security Accreditation Board on security accreditation shall be prepared and taken by professionals who are duly qualified in the field of accrediting complex systems, have an appropriate level of security clearance and who act objectively; (e) efforts shall be made to consult all relevant parties with an interest in security issues for the component concerned; (f) security accreditation activities shall be carried out by all relevant stakeholders of the component concerned in accordance with a security accreditation strategy, without prejudice to the role of the Commission; (g) decisions of the Security Accreditation Board on security accreditation shall, following the process defined in the relevant security accreditation strategy defined by that Board, be based on local decisions on security accreditation taken by the respective national security accreditation authorities of the Member States; (h) a permanent, transparent and fully understandable monitoring process shall ensure that the security risks for the component concerned are known, that security measures are defined to reduce such risks to an acceptable level, in view of the security needs of the Union and of its Member States, and for the smooth running of the component and that those measures are applied in accordance with the concept of defence in depth. The effectiveness of such measures shall be continuously evaluated. The process relating to security risk assessment and management shall be conducted as an iterative process jointly by the stakeholders of the component concerned; (i) the Security Accreditation Board shall take decisions on security accreditation in a strictly independent manner, including with regard to the Commission and the other bodies responsible for the implementation of the component concerned and for the provision of related services, and with regard to the Executive Director and the Administrative Board of the Agency; (j) security accreditation activities shall be carried out with due regard for the need for adequate coordination between the Commission and the authorities responsible for implementing security rules; (k) the security accreditation of EGNOS performed by the Security Accreditation Board shall be without prejudice to the accreditation activities performed, for aviation, by the European Aviation Safety Agency. Article 38 Tasks of the Security Accreditation Board 1. The Security Accreditation Board shall perform its tasks without prejudice to the responsibilities of the Commission or to those entrusted to the Agency\u2019s other bodies, in particular for matters relating to security, and without prejudice to the competences of the Member States as regards security accreditation. 2. The Security Accreditation Board shall have the following tasks: (a) defining and approving a security accreditation strategy which sets out: (i) the scope of the activities necessary to perform and maintain the accreditation of the Programme\u2019s components or parts of those components and any interconnections between them and other systems or components; (ii) a security accreditation process for the Programme\u2019s components or parts of those components, with a degree of detail commensurate with the required level of assurance and clearly stating the accreditation conditions; (iii) the role of relevant stakeholders involved in the accreditation process; (iv) an accreditation schedule that complies with the phases of the Programme\u2019s components, in particular as regards the deployment of infrastructure, service provision and evolution; (v) the principles of security accreditation for networks connected to systems set up under the Programme\u2019s components or for parts of those components, and for equipment connected to systems established by those components, which shall be performed by the national entities of the Member States competent in security matters; (b) taking decisions on security accreditation, in particular on the approval of satellite launches, the authorisation to operate the systems set up under the Programme\u2019s components or the elements of those components in their different configurations and for the various services they provide, up to and including the signal in space, and the authorisation to operate the ground stations; (c) taking decisions concerning the networks and the equipment connected to the PRS service referred to in Article 45, or connected to any other secure service stemming from the Programme\u2019s components, only on the authorisation of bodies to develop or manufacture sensitive PRS technologies, PRS receivers or PRS security modules, or any other technology or equipment which has to be checked under the general security requirements referred to in Article 34(2), taking into account the advice provided by national entities competent in security matters and the overall security risks; (d) examining and, except as regards documents which the Commission is to adopt under Article 34(2) of this Regulation and Article 8 of Decision No 1104/2011/EU, approving all documentation relating to security accreditation; (e) advising, within its field of competence, the Commission on the production of draft texts for acts referred to in Article 34(2) of this Regulation and Article 8 of Decision No 1104/2011/EU, including for the establishment of security operating procedures, and providing a statement with its concluding position; (f) examining and approving the security risk assessment drawn up in accordance with the monitoring process referred to in point (h) of Article 37 of this Regulation, taking into account compliance with the documents referred to in point (c) of this paragraph and those drawn up in accordance with Article 34(2) of this Regulation, and with Article 8 of Decision No 1104/2011/EU; and cooperating with the Commission to define risk mitigation measures; (g) checking the implementation of security measures in relation to the security accreditation of the Programme\u2019s components by undertaking or sponsoring security assessments, inspections, audits or reviews, in accordance with Article 42(2) of this Regulation; (h) endorsing the selection of approved products and measures which protect against electronic eavesdropping (TEMPEST) and of approved cryptographic products used to provide security for the Programme\u2019s components; (i) approving or, where relevant, participating in the joint approval, together with the relevant entities competent in security matters, of the interconnection between the systems established under the Programme\u2019s components or under parts of those components and other systems; (j) agreeing with the relevant Member State on the template for access control referred to in Article 42(4); (k) preparing risk reports and informing the Commission, the Administrative Board and the Executive Director of its risk assessment and advising them on residual risk treatment options for a given decision on security accreditation; (l) assisting, in close liaison with the Commission, the Council and the High Representative, with the implementation of Decision (CFSP) 2021/698 upon a specific request from the Council or the High Representative; (m) carrying out consultations which are necessary to perform its tasks; (n) adopting and publishing its rules of procedure. 3. Without prejudice to the powers and responsibilities of the Member States, a special subordinate body representing the Member States shall be set up under the supervision of the Security Accreditation Board to perform in particular the following tasks: (a) the management of the Programme flight keys; (b) the verification, monitoring and assessment of the establishment and enforcement of procedures for accounting, secure handling, storage, distribution and disposal of the PRS keys of Galileo. Article 39 Composition of the Security Accreditation Board 1. The Security Accreditation Board shall be composed of a representative of each Member State, a representative of the Commission and a representative of the High Representative. The term of office of the members of the Security Accreditation Board shall be four years and shall be renewable. 2. Participation in Security Accreditation Board meetings shall be on a need-to-know-basis. Where appropriate, representatives of ESA and representatives of the Agency not involved in security accreditation may be invited to attend the meetings of the Security Accreditation Board as observers. On an exceptional basis, representatives of Union Agencies, third countries or international organisations may also be invited to attend meetings of the Security Accreditation Board as observers for matters directly relating to those third countries or international organisations, especially matters concerning the infrastructure belonging to them or established on their territory. Arrangements for such participation of representatives of third countries or international organisations and the condition for such participation shall be laid down in the relevant agreements and shall comply with the rules of procedure of the Security Accreditation Board. Article 40 Voting rules of the Security Accreditation Board If consensus according to the general principle referred to in point (b) of Article 37 of this Regulation cannot be reached, the Security Accreditation Board shall take decisions on the basis of qualified majority voting, in accordance with Article 16 TEU. The representative of the Commission and the representative of the High Representative shall not vote. The Chairperson of the Security Accreditation Board shall sign, on behalf of the Security Accreditation Board, the decisions adopted by the Security Accreditation Board. Article 41 Communication and impact of decisions of the Security Accreditation Board 1. The decisions of the Security Accreditation Board shall be addressed to the Commission. 2. The Commission shall keep the Security Accreditation Board continuously informed of the impact of any decisions envisaged by the Security Accreditation Board on the proper conduct of the Programme\u2019s components and of the implementation of residual risk treatment plans. The Security Accreditation Board shall take note of any such information received from the Commission. 3. The Commission shall keep the European Parliament and the Council informed, without delay, of the impact of the adoption of the decisions on security accreditation on the proper conduct of the Programme\u2019s components. If the Commission considers that a decision taken by the Security Accreditation Board could have a significant effect on the proper conduct of those components, for example in terms of costs, schedule or performance, it shall immediately inform the European Parliament and the Council. 4. The Administrative Board shall be kept periodically informed of the evolution of the work of the Security Accreditation Board. 5. The timetable for the work of the Security Accreditation Board shall not hamper the timetable of activities provided in the work programme referred to in Article 100. Article 42 Role of the Member States in security accreditation 1. Member States shall transmit to the Security Accreditation Board all information they consider relevant for the purposes of security accreditation. 2. In agreement with and under the supervision of national entities competent in security matters, Member States shall permit duly authorised persons appointed by the Security Accreditation Board to have access to any information and to any areas and sites related to the security of systems falling within their jurisdiction, in accordance with their national laws and regulations, including for the purposes of security inspections, audits and tests as decided by the Security Accreditation Board and of the security risk monitoring process referred to in point (h) of Article 37. That access shall be without any discrimination on the grounds of nationality against nationals of Member States. 3. Audits and tests referred to in paragraph 2 shall be performed in accordance with the following principles: (a) the importance of security and effective risk management within the entities inspected shall be emphasised; (b) countermeasures to mitigate the specific impact of loss of confidentiality, integrity or availability of classified information shall be recommended. 4. Each Member State shall be responsible for devising a template for access control, which outlines or lists the areas or sites to be accredited. The template for access control shall be agreed in advance between the Member States and the Security Accreditation Board, thereby ensuring that the same level of access control is being provided by all Member States. 5. Member States shall be responsible, at local level, for the accreditation of the security of sites that are located within their territory and form part of the security accreditation area for the Programme\u2019s components, and report, to this end, to the Security Accreditation Board. CHAPTER III Protection of classified information Article 43 Protection of classified information 1. The exchange of classified information related to the Programme shall be subject to the existence of an international agreement between the Union and a third country or international organisation on the exchange of classified information or, where applicable, an arrangement entered into by the competent Union institution or body and the relevant authorities of a third country or international organisation on the exchange of classified information, and to the conditions laid down therein. 2. Natural persons resident in and legal persons established in third countries may deal with EUCI regarding the Programme only where they are subject, in those third countries, to security regulations ensuring a degree of protection at least equivalent to that provided by the Commission\u2019s rules on security set out in Decision (EU, Euratom) 2015/444 and by the security rules of the Council set out in the Annexes to Decision 2013/488/EU. The equivalence of the security regulations applied in a third country or international organisation shall be defined in a security of information agreement, including, if relevant, industrial security matters, concluded between the Union and that third country or international organisation in accordance with the procedure provided for in Article 218 TFEU and taking into account Article 13 of Decision 2013/488/EU. 3. Without prejudice to Article 13 of Decision 2013/488/EU and to the rules governing the field of industrial security as set out in Decision (EU, Euratom) 2015/444, a natural person or legal person, third country or international organisation may be given access to EUCI where deemed necessary on a case-by-case basis, according to the nature and content of such information, the recipient\u2019s need-to-know and the degree of advantage to the Union. TITLE VI GALILEO AND EGNOS Article 44 Eligible actions The exploitation of Galileo and EGNOS shall cover the following eligible actions: (a) the management, operation, maintenance, continuous improvement, evolution and protection of space-based infrastructure, including upgrades and obsolescence management; (b) the management, operation, maintenance, continuous improvement, evolution and protection of the ground-based infrastructure, in particular ground-based centres and stations referred to in Implementing Decision (EU) 2016/413 or Commission Implementing Decision (EU) 2017/1406 (45), networks, including upgrades and obsolescence management; (c) the development of future generations of the systems and the evolution of the services provided by Galileo and EGNOS, including by taking into account the needs of relevant stakeholders; this shall not affect future decisions on the Union financial perspectives; (d) support the development of Galileo and EGNOS downstream applications and the development and evolution of fundamental technological elements, such as Galileo-enabled chipsets and receivers; (e) the support of certification and standardisation activities related to Galileo and EGNOS, in particular in the transport sector; (f) the continuous provision of the services provided by Galileo and EGNOS and, in complementarity with Member States and private sector initiatives, the market development of those services, in particular in order to maximise the socio-economic benefits referred to in point (b) of Article 4(1); (g) cooperation with other regional or global satellite navigation systems, including to facilitate compatibility and interoperability; (h) elements to monitor the reliability of the systems and their exploitation, and the performance of the services; (i) activities related to the provision of services and to the coordination of the extension of their coverage. Article 45 Services provided by Galileo 1. The services provided by Galileo shall comprise: (a) a Galileo open service (GOS), which shall be free of charge for users and shall provide positioning and synchronisation information intended mainly for high-volume satellite navigation applications for use by consumers; (b) a high-accuracy service (HAS), which shall be free of charge for users and shall provide, through additional data disseminated in a supplementary frequency band, high-accuracy positioning and synchronisation information intended mainly for satellite navigation applications for professional or commercial use; (c) a signal authentication service (SAS), based on the encrypted codes contained in the signals, intended mainly for satellite navigation applications for professional or commercial use; (d) a public regulated service (PRS), which shall be restricted to government-authorised users for sensitive applications which require a high level of service continuity, including in the area of security and defence, using strong, encrypted signals; it shall be free of charge for the Member States, the Council, the Commission, EEAS and, where appropriate, duly authorised Union agencies; the question of whether to charge the other PRS participants referred to in Article 2 of Decision No 1104/2011/EU shall be assessed on a case-by-case basis and appropriate provisions shall be specified in the agreements concluded pursuant to Article 3(5) of that Decision; access to PRS shall be regulated in accordance with Decision No 1104/2011/EU; (e) an emergency service (ES), which shall be free of charge for users and shall broadcast, through emitting signals, warnings regarding natural disasters or other emergencies in particular areas; where appropriate, it shall be provided in cooperation with Member States national civil protection authorities; (f) a timing service (TS), which shall be free of charge for users and shall provide an accurate and robust reference time, as well as realisation of the coordinated universal time, facilitating the development of timing applications based on Galileo and the use in critical applications. 2. Galileo shall also contribute to: (a) the search and rescue support service (SAR) of the COSPAS-SARSAT system by detecting distress signals transmitted by beacons and relaying messages to them via a return link; (b) integrity-monitoring services standardised at the Union or international level for use by safety-of-life services, on the basis the signals of Galileo open service and in combination with EGNOS and other satellite navigation systems; (c) space weather information via the GNSS Service Centre as referred to in Implementing Decision (EU) 2016/413 and early warning services via the Galileo ground-based infrastructure, intended mainly to reduce the potential risks to users of the services provided by Galileo and other GNSSs related to space. Article 46 Services provided by EGNOS 1. The services provided by EGNOS shall comprise: (a) an EGNOS open service (EOS), which shall be free of direct user charges and shall provide positioning and synchronisation information intended mainly for high-volume satellite navigation applications for use by consumers; (b) EGNOS data access service (EDAS), which shall be free of direct user charges and shall provide positioning and synchronisation information intended mainly for satellite navigation applications for professional or commercial use, offering improved performance and data with greater added value than those obtained through the EOS; (c) a safety-of-life (SoL) service, which shall be free of direct user charges and shall provide positioning and time synchronisation information with a high level of continuity, availability and accuracy, including an integrity message alerting users to any failure in, or out-of-tolerance signals emitted by, Galileo and other GNSSs which EGNOS augments in the coverage area, intended mainly for users for whom safety is essential, in particular in the sector of civil aviation for the purpose of air navigation services, in accordance with ICAO standards, or other transport sectors. 2. The services referred to in paragraph 1 shall be provided as a priority on the territory of all Member States geographically located in Europe, including for that purpose Cyprus, the Azores, the Canary Islands and Madeira, by the end of 2026. 3. The geographical coverage of EGNOS may be extended to other regions of the world, in particular to the territories of candidate countries, of third countries associated with the Single European Sky and of third countries in the European Neighbourhood Policy, subject to technical feasibility and in conformity with security requirements referred to in Article 34(2), and, for the SoL service, on the basis of international agreements. 4. The cost of the extension of the geographical coverage of EGNOS under paragraph 3 of this Article, including the related operating costs specific to these regions, shall not be covered by the budget referred to in Article 11. The Commission shall consider other programmes or instrument to finance such activities. Such extension shall not delay the offering of the services referred to in paragraph 1 of this Article throughout the territory of Member States geographically located in Europe. Article 47 Implementing measures for Galileo and EGNOS Where necessary for the smooth functioning of Galileo and EGNOS and their adoption by the market, the Commission shall, by means of implementing acts, lay down, where necessary, measures required to: (a) manage and reduce the risks inherent in the operation of Galileo and EGNOS, in particular to ensure service continuity; (b) specify the key decision stages to monitor and evaluate the implementation of Galileo and EGNOS; (c) determine the location of the centres belonging to the ground-based infrastructure of Galileo and EGNOS in accordance with security requirements, following an open and transparent process, and ensure their operation; (d) determine the technical and operational specifications relating to the services referred to in points (c), (e) and (f) of Article 45(1) and point (c) of Article 45(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 48 Compatibility, interoperability and standardisation 1. Galileo and EGNOS, and the services which they provide, shall be compatible and interoperable from a technical point of view, including at user level. 2. Galileo and EGNOS, and the services which they provide, shall be compatible and interoperable with other satellite navigation systems and with conventional means of radio navigation, where the necessary compatibility and interoperability requirements and conditions thereof are laid down in international agreements. TITLE VII COPERNICUS CHAPTER I General provisions Article 49 Scope of Copernicus 1. Copernicus shall be implemented building on prior investments, including by stakeholders such as ESA and EUMETSAT and, where appropriate and cost-effective, drawing on the national or regional capacities of Member States and taking into account the capacities of commercial suppliers of comparable data and information and the need to foster competition and market development, while maximising opportunities for European users. 2. Copernicus shall deliver data and information building on the needs of the Copernicus users and based on a free, full and open data policy. 3. Copernicus shall support the formulation, implementation and monitoring of the Union\u2019s and its Member States\u2019 policies in particular in the fields of the environment, climate change, marine, maritime, atmosphere, agriculture and rural development, preservation of cultural heritage, civil protection, infrastructure monitoring, safety and security, as well as the digital economy with the aim to further reduce the administrative burden. 4. Copernicus shall comprise the following elements: (a) data acquisition, which shall include: (i) development and operations of the Copernicus Sentinels; (ii) access to third party space-based Earth observation data; (iii) access to in-situ and other ancillary data; (b) data and information processing through Copernicus Services, which shall include activities for the generation of value-added information to support environmental monitoring, reporting and compliance assurance, civil protection and security services; (c) data access and distribution, which shall include infrastructure and services to ensure the discovery, viewing, access to, distribution and exploitation and long-term preservation of Copernicus data and Copernicus information, in a user-friendly manner; (d) user uptake, market development and capacity building in accordance with Article 28(6), which shall include relevant activities, resources and services to promote Copernicus, Copernicus data and Copernicus Services, as well as related downstream applications and their development at all levels to maximise socio-economic benefits, as referred to in Article 4(1), as well as the collection and analysis of Copernicus users\u2019 needs. 5. Copernicus shall promote the international coordination of observation systems and related exchanges of data in order to strengthen its global dimension and complementarity taking account of international agreements and coordination processes. CHAPTER II Eligible actions Article 50 Eligible actions for data acquisition Eligible actions under Copernicus shall cover: (a) actions to provide enhanced continuity of existing Copernicus Sentinel missions and to develop, launch, maintain and operate further Copernicus Sentinels expanding the observation scope, giving priority in particular to observation capacities for monitoring anthropogenic CO2 and other greenhouse gas emissions, allowing for monitoring polar regions and enabling innovative environmental applications in agriculture, forest, water and marine resources management, and cultural heritage; (b) actions to provide access to Copernicus third-party data and information necessary to generate Copernicus Services or for use by the Union\u2019s institutions, agencies, decentralised services and, where appropriate and cost-effective, national or regional public bodies; (c) actions to provide and coordinate access to Copernicus in-situ and other ancillary data necessary for the generation, calibration and validation of Copernicus data and Copernicus information, including where appropriate and cost-effective the use of existing national capacities and avoiding duplications. Article 51 Eligible actions for Copernicus services 1. Eligible actions under the Copernicus Services shall include: (a) environmental monitoring, reporting and compliance assurance services covering: (i) atmosphere monitoring on a global level to provide information on air quality, with a particular focus at European level, and on the composition of the atmosphere; (ii) marine environment monitoring to provide information on the state and dynamics of ocean, sea and coastal ecosystems, their resources and use; (iii) land monitoring and agriculture to provide information on land cover, land use and land use change, cultural heritage sites, ground motion, urban areas, inland water quantity and quality, forests, agriculture and other natural resources, biodiversity and cryosphere; (iv) climate change monitoring to provide information on anthropogenic CO2 and other greenhouse gas emissions and absorptions, essential climate variables, climate reanalyses, seasonal forecasts, climate projections and attribution, information on the changes in the polar regions and the Arctic, as well as indicators at relevant temporal and spatial scales; (b) emergency management service to provide information in support of and in coordination with public authorities concerned with civil protection, supporting civil protection and emergency response operations (improving early warning activities and crisis response capacities), and prevention and preparedness actions (risk and recovery analyses) in relation to different types of disasters; (c) security service to support surveillance within the Union and at its external borders, maritime surveillance, Union external action responding to security challenges facing the Union and Common Foreign and Security Policy objectives and actions. 2. The Commission, supported where relevant by external independent expertise, shall ensure the relevance of the Copernicus Services by: (a) validating the technical feasibility and fitness for purpose of the requirements expressed by the user communities; (b) assessing the means and solutions, proposed or executed, to meet the requirements of the user communities and the objectives of the Programme. Article 52 Eligible actions for data and information access and distribution 1. Copernicus shall include actions to provide enhanced access to all Copernicus data and Copernicus information and, where appropriate, provide additional infrastructure and services to foster the distribution, access and use of those data and information. 2. Where Copernicus data or Copernicus information are considered to be security sensitive within the meaning of Articles 12 to 16 of Delegated Regulation (EU) No 1159/2013, the Commission may entrust the procurement, the supervision of the acquisition, the access to and the distribution of those data and information to one or more fiduciary entities. Such entities shall set up and maintain a registry of accredited users and grant access to the restricted data through a segregated workflow. CHAPTER III Copernicus data policy Article 53 Copernicus data and Copernicus information policy 1. Copernicus data and Copernicus information shall be provided to Copernicus users under the following free, full and open data policy: (a) Copernicus users may, on a free and worldwide basis, reproduce, distribute, communicate to the public, adapt, and modify all Copernicus data and Copernicus information and combine them with other data and information; (b) the free, full and open data policy shall include the following limitations: (i) the formats, timeliness and dissemination characteristics of Copernicus data and Copernicus information shall be pre-defined; (ii) the licensing conditions of Copernicus third-party data and information used in the production of Copernicus information shall be abided by where applicable; (iii) the security limitations resulting from the general security requirements referred to in Article 34(2); (iv) the protection against the risk of disruption of the system producing or making available Copernicus data and Copernicus information and of the data itself shall be ensured; (v) the protection of reliable access to Copernicus data and Copernicus information for European users shall be ensured. 2. The Commission shall adopt delegated acts in accordance with Article 105 to supplement the specific provisions set out in paragraph 1 of this Article as regards the specifications and conditions and procedures for the access to and use of Copernicus data and Copernicus information. 3. Where imperative grounds of urgency so require, the procedure provided for in Article 106 shall apply to delegated acts adopted pursuant to this Article. 4. The Commission shall issue licences and notices for access and use of Copernicus data and Copernicus information, including attribution clauses, in compliance with the Copernicus data policy as set out in this Regulation and applicable delegated acts adopted pursuant to paragraph 2. TITLE VIII OTHER COMPONENTS OF THE PROGRAMME CHAPTER I SSA Section 1 SST sub-component Article 54 Scope of SST sub-component 1. The SST sub-component shall support the following activities: (a) the establishment, development and operation of a network of ground-based and space-based SST sensors of the Member States, including sensors developed through ESA or the Union private sector, and nationally operated Union sensors, to survey and track space objects and to produce a European catalogue of space objects; (b) the processing and analysis of SST data at national level in order to produce SST information and SST services referred to in Article 55(1); (c) the provision of the SST services referred to in Article 55(1) to the SST users referred to in Article 56; (d) monitoring and seeking synergies with initiatives promoting development and deployment of technologies for spacecraft disposal at the end of operational lifetime and of technological systems for the prevention and elimination of space debris, as well as with the international initiatives in the area of the space traffic management. 2. The SST sub-component shall also provide technical and administrative support to ensure the transition between the Programme and the SST support framework established by Decision No 541/2014/EU. Article 55 SST services 1. SST services shall comprise: (a) the risk assessment of collision between spacecraft or between spacecraft and space debris and the potential generation of collision avoidance alerts during the phases of launch, early orbit, orbit raising, in-orbit operations and disposal phases of spacecraft missions; (b) the detection and characterisation of in-orbit fragmentations, break-ups or collisions; (c) the risk assessment of the uncontrolled re-entry of space objects and space debris into the Earth\u2019s atmosphere and the generation of related information, including the estimation of the timeframe and likely location of possible impact; (d) the development of activities in preparation of: (i) space debris mitigation in order to reduce their generation; and (ii) space debris remediation by managing the existing space debris. 2. SST services shall be free of charge, available at any time without interruption and adapted to the needs of the SST users referred to in Article 56. 3. Member States participating in the SST sub-component, the Commission and, where relevant, the SST Front desk referred to in Article 59(1), shall not be held liable for: (a) damage resulting from the lack of or interruption in the provision of SST services; (b) delay in the provision of SST services; (c) inaccuracy of the information provided through the SST services; (d) action undertaken in response to the provision of SST services. Article 56 SST users 1. Union SST users shall comprise: (a) SST core users: Member States, the EEAS, the Commission, the Council, the Agency as well as public and private spacecraft owners and operators established in the Union; (b) SST non-core users: other public and private entities established in the Union. SST core users shall have access to all SST services referred to in Article 55(1). SST non-core users may have access to SST services referred to in points (b), (c) and (d) of Article 55(1). 2. International SST users shall comprise third countries, international organisations which do not have their headquarters in the Union and private entities which are not established in the Union. They shall have access to SST services referred to in point (d) of Article 55(1) under the following conditions: (a) third countries and international organisations which do not have their headquarters in the Union may have access to SST services pursuant to Article 8(2); (b) private entities which are not established in the Union may have access to SST services subject to an international agreement concluded by the Union, in accordance with Article 8(2), with the third country in which they are established granting them that access. No international agreement shall be required to access publicly available SST services referred to in points (a), (b) and (c) of Article 55(1). 3. The Commission may adopt, by means of implementing acts, detailed provisions concerning the access to SST services and relevant procedures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 57 Participation of Member States in the SST sub-component 1. Member States wishing to participate in the provision of SST services referred to in Article 55(1) covering all orbits shall submit a single joint proposal to the Commission demonstrating compliance with the following criteria: (a) ownership of, or access to, either adequate SST sensors available for the SST sub-component and human resources to operate them, or adequate operational analysis and data processing capabilities specifically designed for SST and available for the SST sub-component; (b) initial security risk assessment of each SST asset performed and validated by the relevant Member State; (c) an action plan taking into account the coordination plan adopted under Article 6 of Decision No 541/2014/EU, for the implementation of the activities set out in Article 54 of this Regulation; (d) the distribution of the different activities among the Expert Teams as designated pursuant to Article 58 of this Regulation; (e) the rules on the sharing of data necessary for achieving the objectives referred to in Article 4 of this Regulation. As concerns criteria set out in points (a) and (b) of the first subparagraph, each Member State wishing to participate in the provision of SST services shall demonstrate compliance with those criteria separately. As concerns criteria set out in points (c), (d) and (e) of the first subparagraph, all Member States wishing to participate in the provision of SST services shall demonstrate compliance with those criteria collectively. 2. The criteria referred to in points (a) and (b) of the first subparagraph of paragraph 1 of this Article shall be deemed to be fulfilled by the Member States participating in the SST sub-component whose designated national entities are members of the Consortium established under Article 7(3) of Decision No 541/2014/EU as of 12 May 2021. 3. Where no joint proposal has been submitted in accordance with paragraph 1 or where the Commission considers that a joint proposal thus submitted does not comply with the criteria referred to in paragraph 1, at least five Member States may submit a new joint proposal to the Commission, demonstrating compliance with the criteria referred to in paragraph 1. 4. The Commission may adopt, by means of implementing acts, the detailed provisions concerning the procedures and elements referred to in paragraphs 1 to 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 58 Organisational framework of Member States\u2019 participation in the SST sub-component 1. Each Member State which has submitted a joint proposal that has been found compliant by the Commission in accordance with Article 57(1) or that has been selected by the Commission pursuant to the procedure referred to in Article 57(3) shall designate a Constituting National Entity established on its territory to represent it. The designated Constituting National Entity shall be a Member State public authority or a body entrusted with the exercise of such public authority. 2. The Constituting National Entities designated pursuant to paragraph 1 of this Article shall conclude an agreement creating an SST partnership (\u2018SST partnership agreement\u2019) and laying down the rules and mechanisms for their cooperation in implementing the activities referred to in Article 54. In particular, the SST partnership agreement shall include the elements mentioned in points (c), (d) and (e) of Article 57(1) and the establishment of a risk management structure to ensure the implementation of the provisions on the use and secure exchange of SST data and SST information. 3. The Constituting National Entities shall develop Union SST services of high quality in accordance with a multiannual plan, relevant key performance indicators and users\u2019 requirements, on the basis of the activities of the Expert Teams referred to in paragraph 6 of this Article. The Commission may adopt, by means of implementing acts, the multiannual plan and the key performance indicators. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 4. The Constituting National Entities shall network existing and possible future sensors to operate them in a coordinated and optimised way with a view to establishing and maintaining an up-to-date common European catalogue, without affecting Member States\u2019 prerogatives in the area of national security. 5. Member States participating in the SST sub-component shall perform security accreditation on the basis of the general security requirements referred to in Article 34(2). 6. Expert Teams shall be designated by the Member States participating in the SST sub-component to be in charge of specific issues related to the different SST activities. The Expert Teams shall be permanent, managed and staffed by the Constituting National Entities of the Member States which designated them and may include experts from every Constituting National Entity. 7. The Constituting National Entities and Expert Teams shall ensure the protection of SST data, SST information and SST services. 8. The Commission shall adopt, by means of implementing acts, detailed rules on the functioning of the organisational framework of the participation of Member States in the SST sub-component. Those rules shall also cover for the inclusion at a later stage of a Member State in the SST partnership by becoming a party to the SST partnership agreement referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 59 SST Front desk 1. The Commission, taking into account the recommendation of the Constituting National Entities, shall select the SST Front Desk on the basis of the best expertise in security issues and in service provision. The SST Front desk shall: (a) provide the necessary secure interfaces to centralise, store and make available SST information to SST users referred to in Article 56, ensuring their adequate handling and traceability; (b) provide reporting on the performance of the SST services to the SST partnership referred to in Article 58(2) and the Commission; (c) gather the necessary feedback for the SST partnership referred to in Article 58(2) to ensure the required alignment of services with SST users\u2019 expectations; (d) support, promote and encourage the use of the SST services. 2. The Constituting National Entities shall conclude the necessary implementing arrangements with the SST Front Desk. Section 2 SWE and NEO sub-components Article 60 SWE activities 1. The SWE sub-component may support the following activities: (a) the assessment and identification of the needs of the users in the sectors identified in point (b) of paragraph 2, with the aim of setting out SWE services to be provided; (b) the provision of SWE services to the SWE services\u2019 users, according to the identified users needs and technical requirements. 2. SWE services shall be available at any time without interruption. The Commission shall select those services, by means of implementing acts, in accordance with the following rules: (a) the Commission shall prioritise the SWE services to be provided at Union level according to the needs of SWE users, the technological readiness of the services and the result of a risk assessment; (b) SWE services may contribute to civil protection activities and to the protection of a wide range of sectors such as space, transport, GNSSs, electric power grids and communications. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2). 3. The selection of public or private entities to provide SWE services shall be performed through a call for tenders. Article 61 NEO activities 1. The NEO sub-component may support the following activities: (a) the mapping of Member States\u2019 capacities for detecting and monitoring near-Earth objects; (b) the promotion of the networking of Member States\u2019 facilities and research centres; (c) the development of the service referred to in paragraph 2; (d) the development of a routine rapid response service able to characterise newly discovered near-Earth objects; (e) the creation of a European catalogue of near-Earth objects. 2. The Commission, in its field of competence, may put in place procedures to coordinate, with the involvement of the appropriate UN bodies, the actions of the Union and national public authorities concerned with civil protection in the event a near-Earth object is found to be approaching Earth. CHAPTER II GOVSATCOM Article 62 Scope of GOVSATCOM Under the GOVSATCOM component, satellite communication capacities and services shall be combined into a common Union pool of satellite communication capacities and services, with appropriate security requirements. This component comprises: (a) the development, construction and the operations of the ground segment infrastructure; referred to in Article 67 and possible space infrastructure referred to in Article 102(2); (b) the procurement of governmental and commercial satellite communication capacities, services, and user equipment necessary for the provision of GOVSATCOM services; (c) measures necessary to further interoperability and standardisation of GOVSATCOM user equipment. Article 63 GOVSATCOM capacities and services 1. The provision of GOVSATCOM capacities and services shall be ensured as laid down in the service portfolio referred to in paragraph 3 of this Article and in accordance with the operational requirements referred to in paragraph 2 of this Article, GOVSATCOM specific security requirements referred to in Article 34(2) and within the limits of the sharing and prioritisation rules referred to in Article 66. Access to GOVSATCOM capacities and services shall be free of charge for institutional and governmental GOVSATCOM users unless the Commission defines a pricing policy in accordance with Article 66(2). 2. The Commission shall adopt, by means of implementing acts, the operational requirements for GOVSATCOM services, in the form of technical specifications for GOVSATCOM use-cases related in particular to crisis management, surveillance and key infrastructure management, including diplomatic communication networks. Those operational requirements shall be based on the detailed analysis of the requirements of GOVSATCOM users and shall take into account requirements stemming from existing user equipment and networks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 3. The Commission shall adopt, by means of implementing acts, the service portfolio for GOVSATCOM services, in the form of a list of categories of satellite communication capacities and services and their attributes, including geographical coverage, frequency, bandwidth, user equipment, and security features. The service portfolio shall take into consideration existing commercially available services in order not to distort competition in the internal market. Those implementing acts shall be regularly updated and shall be based on the operational and security requirements referred to in paragraph 1 of this Article and shall prioritise services provided to users according to their relevance and criticality. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 4. GOVSATCOM users shall have access to the GOVSATCOM capacities and services listed in the service portfolio referred to in paragraph 3 of this Article. That access shall be provided through the GOVSATCOM Hubs referred to in Article 67(1). Article 64 Providers of satellite communication capacities and services Satellite communication capacities and services under GOVSATCOM may be provided by the following entities: (a) GOVSATCOM participants as referred to in Article 68; and (b) legal persons duly accredited to provide satellite communication capacities or services in accordance with the security accreditation procedure referred to in Article 37, which shall be done in compliance with the general security requirements for the GOVSATCOM component, as referred to in Article 34(2). Article 65 GOVSATCOM users 1. The following entities may be GOVSATCOM users provided that they are entrusted with tasks relating to the supervision and management of emergency and security-critical missions, operations and infrastructures: (a) a Union or Member State public authority or a body entrusted with the exercise of such public authority; (b) a natural or legal person acting on behalf of and under the control of an entity referred to under point (a) of this paragraph. 2. GOVSATCOM users referred to in paragraph 1 of this Article shall be duly authorised by a GOVSATCOM participant referred to in Article 68 to use GOVSATCOM capacities and services and shall comply with the general security requirements referred to in Article 34(2), defined for GOVSATCOM. Article 66 Sharing and prioritisation 1. Pooled satellite communication capacities, services and user equipment shall be shared and prioritised between GOVSATCOM participants referred to in Article 68 on the basis of an analysis of safety and security risks of the users. Such analysis shall take into account existing communication infrastructure and availability of existing capabilities as well as their geographical coverage, at Union and national level. That sharing and prioritisation shall prioritise GOVSATCOM users according to their relevance and criticality. 2. The Commission shall adopt, by means of implementing acts, the detailed rules on the sharing and prioritisation of satellite communication capacities, services, and user equipment, taking into account expected demand for the different GOVSATCOM use-cases, the analysis of security risks for those use-cases and, where appropriate, cost-efficiency. By defining a pricing policy in those rules, the Commission shall ensure that the provision of GOVSATCOM capacities and services does not distort the market and that there is no shortage of GOVSATCOM capacities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 3. The sharing and prioritisation of satellite communication capacities and services between GOVSATCOM users which are authorised by the same GOVSATCOM participant shall be determined and implemented by that GOVSATCOM participant. Article 67 Ground segment infrastructure and operation 1. The ground segment shall include infrastructure necessary to enable the provision of services to GOVSATCOM users in accordance with Article 66, particularly the GOVSATCOM Hubs which shall be procured under this component to connect GOVSATCOM users with providers of satellite communication capacities and services. The ground segment and its operation shall comply with the general security requirements referred to in Article 34(2), defined for GOVSATCOM. 2. The Commission shall determine, by means of implementing acts, the location of the ground segment infrastructure. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3), and shall be without prejudice to the right of a Member State to decide not to host any such infrastructure. Article 68 GOVSATCOM participants and competent authorities 1. Member States, the Council, the Commission and the EEAS shall be GOVSATCOM participants insofar as they authorise GOVSATCOM users, or provide satellite communication capacities, ground segment sites or part of the ground segment facilities. Where the Council, the Commission or the EEAS authorise GOVSATCOM users, or provide satellite communication capacities, ground segment sites or part of the ground segment facilities, on the territory of a Member State, such authorisation or provision shall not contravene neutrality or non-alignment provisions stipulated in the constitutional law of that Member State. 2. Union agencies may become GOVSATCOM participants only insofar as necessary to fulfil their tasks and in accordance with detailed rules laid down in an administrative arrangement concluded between the agency concerned and the Union institution that supervises it. 3. Third countries and international organisations may become GOVSATCOM participants in accordance with Article 7. 4. Each GOVSATCOM participant shall designate one competent GOVSATCOM authority. 5. A competent GOVSATCOM authority shall ensure that: (a) the use of services is in compliance with the applicable security requirements; (b) the access rights for GOVSATCOM users are determined and managed; (c) user equipment and associated electronic communication connections and information are used and managed in accordance with applicable security requirements; (d) a central point of contact is established to assist as necessary in the reporting of security risks and threats, in particular the detection of potentially harmful electromagnetic interference affecting the services under this component. Article 69 Monitoring of supply and demand for GOVSATCOM In order to optimise the balance between supply and demand for GOVSATCOM services, the Commission shall continuously monitor the evolution of supply, including existing GOVSATCOM capacities in orbit for pooling and sharing, and demand for GOVSATCOM capacities and services, taking into account new risks and threats, as well as new developments in technology. TITLE IX THE EUROPEAN UNION AGENCY FOR THE SPACE PROGRAMME CHAPTER I General provisions relating to the Agency Article 70 Legal status of the Agency 1. The Agency shall be a body of the Union. It shall have legal personality. 2. In each of the Member States, the Agency shall enjoy the most extensive legal capacity accorded to legal persons under their national laws. It may, in particular, acquire or dispose of movable and immovable property and be a party to legal proceedings. 3. The Agency shall be represented by its Executive Director. Article 71 Seat and local offices of the Agency 1. The seat of the Agency is located in Prague, Czechia. 2. Staff of the Agency may be located in one of the Galileo or EGNOS ground-based centres referred to in Implementing Decision (EU) 2016/413 or (EU) 2017/1406, to execute Programme activities provided for in the relevant agreement. 3. Depending on the needs of the Programme, local offices may be established in the Member States in accordance with the procedure laid down in Article 79(2). CHAPTER II Organisation of the Agency Article 72 Administrative and management structure 1. The Agency\u2019s administrative and management structure shall comprise: (a) the Administrative Board; (b) the Executive Director; (c) the Security Accreditation Board. 2. The Administrative Board, the Executive Director and the Security Accreditation Board shall cooperate to ensure the operation of the Agency and coordination in accordance with the procedures determined by the Agency\u2019s internal rules, such as the rules of procedure of the Administrative Board, the rules of procedure of the Security Accreditation Board, the financial rules applicable to the Agency, the implementing rules of the Staff Regulations of Officials of the European Union (\u2018Staff Regulations\u2019) and the rules governing access to documents. Article 73 Administrative Board 1. The Administrative Board shall be composed of one representative from each Member State, and three representatives of the Commission, all with voting rights. The Administrative Board shall also include one member designated by the European Parliament, with no voting rights. 2. The Chairperson or the Deputy Chairperson of the Security Accreditation Board, a representative of the Council, a representative of the High Representative and a representative of ESA shall be invited to attend the meetings of the Administrative Board as observers for matters related directly to them, under the conditions laid down in the rules of procedure of the Administrative Board. 3. Each member of the Administrative Board shall have an alternate member. The alternate member shall represent the member in his or her absence. 4. Each Member State shall nominate a member and an alternate member of the Administrative Board taking account of their knowledge in the field of the Agency\u2019s tasks and relevant managerial, administrative and budgetary skills. In order to ensure continuity of the Administrative Board\u2019s activities, the European Parliament, the Commission and the Member States shall endeavour to limit changes of their representatives on the Administrative Board. All parties shall aim to achieve a balanced representation between men and women on the Administrative Board. 5. The term of office of the members of the Administrative Board and their alternates shall be four years and shall be renewable. 6. Where appropriate, the participation of representatives of third countries or international organisations and the conditions for such participation shall be established in the agreements referred to in Article 98 and shall comply with the rules of procedure of the Administrative Board. Those representatives shall have no voting rights. Article 74 Chairperson of the Administrative Board 1. The Administrative Board shall elect a Chairperson and a Deputy Chairperson from among its members having voting rights. The Deputy Chairperson shall automatically replace the Chairperson if he or she is prevented from attending to his or her duties. 2. The term of office of the Chairperson and of the Deputy Chairperson shall be two years, and shall be renewable once. Each term of office shall end when that person ceases to be a member of the Administrative Board. 3. The Administrative Board shall have the power to dismiss the Chairperson, the Deputy Chairperson or both of them. Article 75 Meetings of the Administrative Board 1. Meetings of the Administrative Board shall be convened by its Chairperson. 2. The Executive Director shall take part in the deliberations of the Administrative Board, unless the Chairperson decides otherwise. The Executive Director shall not have the right to vote. 3. The Administrative Board shall hold ordinary meetings on a regular basis, at least twice a year. In addition, it shall meet on the initiative of its Chairperson or at the request of at least one third of its members. 4. The Administrative Board may invite any person whose opinion may be of interest to attend its meetings as an observer. The members of the Administrative Board may, subject to its rules of procedure, be assisted by advisers or experts. 5. Where discussion concerns the use of sensitive national infrastructure, the representatives of Member States and the representatives of the Commission may attend the meetings and deliberations of the Administrative Board, on a need-to-know basis. However, only those representatives of Member States which possess such infrastructure and the representatives of the Commission are to take part in voting. Where the Chairperson of the Administrative Board does not represent one of the Member States which possess such infrastructure, he or she shall be replaced by the representatives of Member States which possess such infrastructure. The rules of procedure of the Administrative Board shall set out the situations in which this procedure may apply. 6. The Agency shall provide the secretariat of the Administrative Board. Article 76 Voting rules of the Administrative Board 1. Unless this Regulation provides otherwise, the Administrative Board shall take its decisions by a majority of its voting members. A majority of two thirds of all voting members shall be required for the election and dismissal of the Chairperson and Deputy Chairperson of the Administrative Board and for the adoption of the budget, work programmes, approval of arrangements referred to in Article 98(2), security rules of the Agency, adoption of the rules of procedure, for the establishment of local offices and for the approval of the hosting agreements referred to in Article 92. 2. Each representative of the Member States and of the Commission shall have one vote. In the absence of a member with the right to vote, his or her alternate shall be entitled to exercise his or her right to vote. Decisions based on point (a) of Article 77(2), except for matters under Chapter II of Title V, or on Article 77(5), shall only be adopted with a favourable vote of the representatives of the Commission. 3. The rules of procedure of the Administrative Board shall establish more detailed voting arrangements, in particular the conditions for a member to act on behalf of another member as well as any quorum requirements as appropriate. Article 77 Tasks of the Administrative Board 1. The Administrative Board shall ensure that the Agency carries out the work entrusted to it, under the conditions set out in this Regulation, and shall take any necessary decision to that end. This shall not affect the competences entrusted to the Security Accreditation Board for the activities under Chapter II of Title V. 2. The Administrative Board shall also: (a) adopt, by 15 November each year, the Agency\u2019s work programme for the following year after incorporating, without any change, the section drafted by the Security Accreditation Board, in accordance with point (b) of Article 80, and after having received the Commission\u2019s opinion; (b) adopt, by 30 June of the first year of the multiannual financial framework provided for under Article 312 TFEU, the multiannual work programme of the Agency for the period covered by that multiannual financial framework after incorporating, without any change, the section drafted by the Security Accreditation Board in accordance with point (a) of Article 80 of this Regulation and after having received the Commission\u2019s opinion. The European Parliament shall be consulted on the multiannual work programme, provided that the purpose of the consultation is an exchange of views and the outcome is not binding on the Agency; (c) perform the budgetary functions laid down in Article 84(5), (6), (10) and (11); (d) oversee the operation of the Galileo Security Monitoring Centre as referred to in point (b) of Article 34(5); (e) adopt arrangements to implement Regulation (EC) No 1049/2001 of the European Parliament and of the Council (46), in accordance with Article 94 of this Regulation; (f) approve the arrangements referred to in Article 98, after consulting the Security Accreditation Board on the provisions of the arrangements concerning security accreditation; (g) adopt the technical procedures necessary to perform its tasks; (h) adopt the annual report on the activities and prospects of the Agency, having incorporated, without any change, the section drafted by the Security Accreditation Board in accordance with point (c) of Article 80 and forward it to the European Parliament, the Council, the Commission and the Court of Auditors by 1 July each year; (i) ensure adequate follow-up to the findings and recommendations arising from the evaluations and audits referred to in Article 102, as well as those arising from investigations conducted by OLAF and all internal or external audit reports, and forward all information relevant to the outcome of the evaluation procedures to the budgetary authority; (j) be consulted by the Executive Director on the FFPA referred to in Article 31 and contribution agreements referred to in Article 27(3) and Article 29(5) before they are signed; (k) adopt the security rules of the Agency as referred to in Article 96; (l) approve an anti-fraud strategy, on the basis of a proposal from the Executive Director; (m) where necessary and on the basis of proposals from the Executive Director, approve the organisational structures referred to in point (l) of Article 79(1); (n) appoint an Accounting Officer, who may be the Commission\u2019s Accounting Officer, who shall be: (i) subject to the Staff Regulations and the Conditions of Employment of Other Servants of the Union (\u2018Conditions of Employment\u2019), laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (47); and (ii) totally independent in the performance of his or her duties; (o) adopt and publish its rules of procedure. 3. With regard to the Agency\u2019s staff, the Administrative Board shall exercise the powers conferred by the Staff Regulations on the appointing authority and by the Conditions of Employment on the authority empowered to conclude employment contracts (the \u2018powers of the appointing authority\u2019). The Administrative Board shall adopt, in accordance with the procedure provided for in Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment delegating the relevant powers of the appointing authority to the Executive Director and defining the conditions under which this delegation of powers can be suspended. The Executive Director shall report back to the Administrative Board on the exercise of those delegated powers. The Executive Director shall be authorised to sub-delegate those powers. In application of the second subparagraph of this paragraph, where exceptional circumstances so require, the Administrative Board may, by decision, temporarily suspend the delegation of the powers of the appointing authority to the Executive Director and those subdelegated by the Executive Director and exercise them itself or delegate them to one of its members or to a staff member other than the Executive Director. By way of derogation from the second subparagraph of this paragraph, the Administrative Board shall be required to delegate to the Chairperson of the Security Accreditation Board the powers referred to in the first subparagraph with regard to the recruitment, assessment and reclassification of staff involved in the activities under Chapter II of Title V and the disciplinary measures to be taken with regard to such staff. The Administrative Board shall adopt the implementing measures of the Staff Regulations and the Conditions of Employment in accordance with the procedure laid down in Article 110 of the Staff Regulations. It shall first consult the Security Accreditation Board and duly take into account its observations with regard to the recruitment, assessment and reclassification of the staff involved in the activities under Chapter II of Title V of this Regulation and the relevant disciplinary measures to be taken. The Administrative Board shall also adopt a decision laying down rules on the secondment of national experts to the Agency. Before adopting that decision, the Administrative Board shall consult the Security Accreditation Board with regard to the secondment of national experts involved in the security accreditation activities under Chapter II of Title V and shall duly take account of its observations. 4. The Administrative Board shall appoint the Executive Director and may extend or end his or her term of office pursuant to Article 89. 5. Except in respect of activities undertaken in accordance with Chapter II of Title V, the Administrative Board shall exercise disciplinary authority over the Executive Director in relation to his or her performance, in particular as regards security matters falling within the Agency\u2019s competence. Article 78 Executive Director 1. The Agency shall be managed by its Executive Director. The Executive Director shall be accountable to the Administrative Board. This paragraph shall not affect the autonomy or independence of the Security Accreditation Board and of the Agency staff under its supervision in accordance with Article 82 and the powers granted to the Security Accreditation Board and the Chairperson of the Security Accreditation Board in accordance with Articles 38 and 81 respectively. 2. Without prejudice to the powers of the Commission and the Administrative Board, the Executive Director shall be independent in the performance of his or her duties and shall neither seek nor take instructions from any government or from any other body. Article 79 Tasks of the Executive Director 1. The Executive Director shall perform the following tasks: (a) represent the Agency and sign the agreements referred to in Article 27(3), Article 29(5) and Article 31; (b) prepare the work of the Administrative Board and participate, without having the right to vote, in the work of the Administrative Board, subject to the second subparagraph of Article 75(2); (c) implement the decisions of the Administrative Board; (d) prepare the multiannual and annual work programmes of the Agency and submit them to the Administrative Board for approval, with the exception of the parts prepared and adopted by the Security Accreditation Board in accordance with points (a) and (b) of Article 80; (e) implement the multiannual and annual work programmes, with the exception of the parts implemented by the Chairperson of the Security Accreditation Board; (f) prepare a progress report on the implementation of the annual work programme and, where relevant, of the multiannual work programme for each meeting of the Administrative Board, incorporating, without any change, the section prepared by the Chairperson of the Security Accreditation Board; (g) prepare the annual report on the activities and prospects of the Agency with the exception of the section prepared and approved by the Security Accreditation Board in accordance with point (c) of Article 80 concerning the activities under Title V, and submit it to the Administrative Board for approval; (h) handle the day-to-day administration of the Agency and take all necessary measures to ensure the functioning of the Agency in accordance with this Regulation, including the adoption of internal administrative instructions and the publication of notices; (i) draw up a draft statement of estimates of revenue and expenditure for the Agency in accordance with Article 84 and implement the budget in accordance with Article 85; (j) ensure that the Agency, as the operator of the Galileo Security Monitoring Centre, is able to respond to instructions provided under Decision (CFSP) 2021/698 and to fulfil its role as referred to in Article 6 of Decision No 1104/2011/EU; (k) ensure the circulation of all relevant information, in particular as regards security, within the Agency structure referred to in Article 72(1); (l) determine, in close cooperation with the Chairperson of the Security Accreditation Board for matters relating to security accreditation activities under Chapter II of Title V, the organisational structures of the Agency and submit them to the Administrative Board for approval; those structures shall reflect the specific characteristics of the Programme\u2019s various components; (m) with regard to the Agency\u2019s staff, exercise the powers of the appointing authority referred to in the first subparagraph of Article 77(3) to the extent that those powers have been delegated to him or her in accordance with the second subparagraph of Article 77(3); (n) ensure that secretarial services and all the resources necessary for their proper functioning are provided to the Security Accreditation Board, the bodies referred to in Article 38(3) and Article 82(3) and the Chairperson of the Security Accreditation Board; (o) with the exception of the section of the action plan concerning the activities under Chapter II of Title V, prepare an action plan for ensuring the follow-up of the findings and recommendations of the evaluations referred to in Article 102 and, after having incorporated, without any change, the section drafted by the Security Accreditation Board, submit a twice-yearly progress report to the Commission, which shall also be submitted to the Administrative Board for information; (p) take the following measures to protect the financial interests of the Union: (i) preventive measures against fraud, corruption or any other illegal activity and making use of effective supervisory measures; (ii) recover sums unduly paid where irregularities are detected and, where appropriate, apply effective, proportionate and dissuasive administrative and financial penalties; (q) draw up an anti-fraud strategy for the Agency that is proportionate to the risk of fraud, having regard to a cost-benefit analysis of the measures to be implemented and taking into account findings and recommendations arising from OLAF investigations and submit it to the Administrative Board for approval; (r) provide reports to the European Parliament on the performance of his or her duties when invited to do so; the Council may invite the Executive Director to report on the performance of his or her duties. 2. The Executive Director shall decide whether it is necessary to locate one or more members of staff in one or more Member States for the purpose of carrying out the Agency\u2019s tasks in an efficient and effective manner. Before deciding to establish a local office the Executive Directive shall obtain the prior approval of the Commission, the Administrative Board and the Member State(s) concerned. The decision shall specify the scope of the activities to be carried out at the local office in a manner that avoids unnecessary costs and duplication of administrative functions of the Agency. Where possible, the impact in terms of staff allocation and budget shall be incorporated in the draft single programming document referred to in Article 84(6). Article 80 Management tasks of the Security Accreditation Board Apart from the tasks referred to in Article 38, the Security Accreditation Board shall, as part of the management of the Agency: (a) prepare and approve that part of the multiannual work programme concerning the operational activities under Chapter II of Title V and the financial and human resources needed to accomplish those activities, and submit it to the Administrative Board in good time for it to be incorporated into the multiannual work programme; (b) prepare and approve that part of the annual work programme concerning the operational activities under Chapter II of Title V and the financial and human resources needed to accomplish those activities, and submit it to the Administrative Board in good time for it to be incorporated into the annual work programme; (c) prepare and approve that part of the annual report concerning the Agency\u2019s activities and prospects under Chapter II of Title V and the financial and human resources needed to accomplish those activities and prospects, and submit it to the Administrative Board in good time for it to be incorporated into the annual report. Article 81 The Chairperson of the Security Accreditation Board 1. The Security Accreditation Board shall elect a Chairperson and a Deputy Chairperson from among its members by a two-thirds majority of all members with the right to vote. Where a two-thirds majority has not been achieved following two meetings of the Security Accreditation Board, a simple majority shall be required. 2. The Deputy Chairperson shall automatically replace the Chairperson if the Chairperson is unable to attend to his or her duties. 3. The Security Accreditation Board shall have the power to dismiss the Chairperson, the Deputy Chairperson or both of them. It shall adopt the decision to dismiss by a two-thirds majority. 4. The term of office of the Chairperson and of the Deputy Chairperson of the Security Accreditation Board shall be two years, renewable once. Each term of office shall end when that person ceases to be a member of the Security Accreditation Board. Article 82 Organisational aspects of the Security Accreditation Board 1. The Security Accreditation Board shall have access to all the human and material resources required to perform its tasks independently. It shall have access to any information useful for the performance of its tasks in the possession of the other bodies of the Agency, without prejudice to the principles of autonomy and independence referred to in point (i) of Article 37. 2. The Security Accreditation Board and the Agency staff under its supervision shall perform their work in a manner ensuring autonomy and independence in relation to the other activities of the Agency, in particular operational activities associated with the exploitation of the systems, in accordance with the objectives of the Programme\u2019s various components. A member of the Agency\u2019s staff under the supervision of the Security Accreditation Board shall not at the same time be assigned to other tasks within the Agency. To that end, an effective organisational segregation shall be established within the Agency between the staff involved in activities under Chapter II of Title V and the other staff of the Agency. The Security Accreditation Board shall immediately inform the Executive Director, the Administrative Board and the Commission of any circumstances that could hamper its autonomy or independence. In the event that no remedy is found within the Agency, the Commission shall examine the situation, in consultation with the relevant parties. On the basis of the outcome of that examination, the Commission shall take appropriate mitigation measures to be implemented by the Agency and shall inform the European Parliament and the Council thereof. 3. The Security Accreditation Board shall set up special subordinate bodies, acting on its instructions, to deal with specific issues. In particular, while ensuring necessary continuity of work, it shall set up a panel to conduct security analysis reviews and tests and produce the relevant risk reports in order to assist it in preparing its decisions. The Security Accreditation Board may set up and disband expert groups to contribute to the work of the panel. Article 83 Tasks of the Chairperson of the Security Accreditation Board 1. The Chairperson of the Security Accreditation Board shall ensure that the Board carries out its security accreditation activities independently and shall perform the following tasks: (a) manage security accreditation activities under the supervision of the Security Accreditation Board; (b) implement the part of the Agency\u2019s multiannual and annual work programmes under Chapter II of Title V under the supervision of the Security Accreditation Board; (c) cooperate with the Executive Director to help to draw up the draft establishment plan referred to in Article 84(4) and the organisational structures of the Agency; (d) prepare the section of the progress report concerning the operational activities under Chapter II of Title V, and submit it to the Security Accreditation Board and the Executive Director in good time for it to be incorporated into the progress report; (e) prepare the section of the annual report and of the action plan, concerning the operational activities under Chapter II of Title V, and submit it to the Executive Director in good time; (f) represent the Agency for the activities and decisions under Chapter II of Title V; (g) with regard to the Agency\u2019s staff involved in the activities under Chapter II of Title V, exercise the powers referred to in the first subparagraph of Article 77(3), delegated to him or her in accordance with the fourth subparagraph of Article 77(3). 2. For activities under Chapter II of Title V, the European Parliament and the Council may call upon the Chairperson of the Security Accreditation Board for an exchange of views before those institutions on the work and prospects of the Agency, including with regard to the multiannual and annual work programmes. CHAPTER III Financial provisions relating to the Agency Article 84 The Agency\u2019s budget 1. Without prejudice to other resources and dues, the revenue of the Agency shall include a Union contribution entered in Union budget in order to ensure a balance between revenue and expenditure. The Agency may receive ad hoc grants from the Union budget. 2. The expenditure of the Agency shall cover staff, administrative and infrastructure expenditure, operating costs and expenditure associated with the functioning of the Security Accreditation Board, including the bodies referred to in Article 38(3) and Article 82(3), and the contracts and agreements concluded by the Agency in order to accomplish the tasks entrusted to it. 3. Revenue and expenditure shall be in balance. 4. The Executive Director shall, in close collaboration with the Chairperson of the Security Accreditation Board for activities under Chapter II of Title V, draw up a draft statement of estimates of revenue and expenditure for the Agency for the next financial year, making clear the distinction between those elements of the draft statement of estimates which relate to security accreditation activities and those relating to the Agency\u2019s other activities. The Chairperson of the Security Accreditation Board may write a statement on that draft and the Executive Director shall forward both the draft statement of estimates and the statement to the Administrative Board and the Security Accreditation Board, together with a draft establishment plan. 5. Each year, based on the draft statement of estimates of revenue and expenditure and in close cooperation with the Security Accreditation Board for activities under Chapter II of Title V, the Administrative Board shall draw up the statement of estimates of revenue and expenditure for the Agency for the next financial year. 6. By 31 January each year, the Administrative Board shall forward a draft single programming document including inter alia a statement of estimates, a draft establishment plan and a provisional annual work programme to the Commission and to the third countries or international organisations with which the Agency has entered into arrangements in accordance with Article 98. 7. The Commission shall forward the statement of estimates of revenue and expenditure to the European Parliament and to the Council (the \u2018budgetary authority\u2019) together with the draft general budget of the European Union. 8. On the basis of the statement of estimates, the Commission shall enter in the draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget. The Commission is to submit the draft general budget to the budgetary authority in accordance with Article 314 TFEU. 9. The budgetary authority shall authorise the appropriations for the contribution to the Agency and shall adopt the establishment plan for the Agency. 10. The budget shall be adopted by the Administrative Board. It shall become final following final adoption of the general budget of the European Union. Where necessary, the budget shall be adjusted accordingly. 11. The Administrative Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which would have significant financial implications for the funding of the budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. 12. Where an arm of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Administrative Board within a period of six weeks from the date of notification of the project. Article 85 Implementation of the Agency\u2019s budget 1. The Executive Director shall implement the Agency\u2019s budget. 2. Each year, the Executive Director shall communicate to the budgetary authority all the information needed for the exercise of their evaluation duties. Article 86 Presentation of the Agency\u2019s accounts and discharge The presentation of the Agency\u2019s provisional and final accounts and the discharge shall follow the rules and timetable of the Financial Regulation and of the framework financial regulation for the bodies referred to in Article 70 of the Financial Regulation. Article 87 Financial provisions relating to the Agency The financial rules applicable to the Agency shall be adopted by the Administrative Board after consulting the Commission. Those rules shall not depart from the framework financial regulation for the bodies referred to in Article 70 of the Financial Regulation unless such a departure is specifically required for the Agency\u2019s operation and the Commission has given its prior consent. CHAPTER IV The Agency\u2019s human resources Article 88 The Agency\u2019s staff 1. The Staff Regulations, the Conditions of Employment and the rules adopted jointly by the institutions of the Union for the purposes of the application of those Staff Regulations and Conditions of Employment shall apply to the staff employed by the Agency. 2. The staff of the Agency shall consist of servants recruited by the Agency as necessary to perform its tasks. They shall have security clearance appropriate to the classification of the information they handle. 3. The Agency\u2019s internal rules, such as the rules of procedure of the Administrative Board, the rules of procedure of the Security Accreditation Board, the financial rules applicable to the Agency, the rules implementing the Staff Regulations and the rules for access to documents, shall ensure the autonomy and independence of staff performing the security accreditation activities vis-\u00e0-vis staff performing the other activities of the Agency, pursuant to point (i) of Article 37. Article 89 Appointment and term of office of the Executive Director 1. The Executive Director shall be recruited as a temporary member of staff of the Agency in accordance with point (a) of Article 2 of the Conditions of Employment. The Executive Director shall be appointed by the Administrative Board on grounds of merit and documented administrative and managerial skills, as well as relevant competence and experience, from a list of at least three candidates proposed by the Commission, after an open and transparent competition, following the publication of a call for expressions of interest in the Official Journal of the European Union or elsewhere. The candidate selected by the Administrative Board for the post of Executive Director may be invited at the earliest opportunity to make a statement before the European Parliament and to answer questions from its members. The Chairperson of the Administrative Board shall represent the Agency for the purpose of concluding the contract of the Executive Director. The Administrative Board shall take its decision to appoint the Executive Director by a two-thirds majority of its members. 2. The term of office of the Executive Director shall be five years. At the end of that term of office, the Commission shall carry out an assessment of the performance of the Executive Director, taking into account the future tasks and challenges facing the Agency. On the basis of a proposal from the Commission, taking into account the assessment referred to in the first subparagraph, the Administrative Board may extend the term of office of the Executive Director once for a period of up to five years. Any decision to extend the term of office of the Executive Director shall be adopted by a two-thirds majority of the members of the Administrative Board. An Executive Director whose term of office has been extended shall not thereafter take part in a selection procedure for the same post. The Administrative Board shall inform the European Parliament of its intention to extend the term of office of the Executive Director. Before the extension, the Executive Director may be invited to make a statement before the relevant committees of the European Parliament and answer their members\u2019 questions. 3. The Administrative Board may dismiss the Executive Director, on the basis of a proposal by the Commission or of one third of its members, by means of a decision adopted by a two-thirds majority of its members. 4. The European Parliament and the Council may call upon the Executive Director for an exchange of views before those institutions on the work and prospects of the Agency, including with regard to the multiannual and annual work programmes. That exchange of views shall not touch upon matters relating to the security accreditation activities under Chapter II of Title V. Article 90 Secondment of national experts to the Agency The Agency may employ national experts from Member States, as well as, pursuant to Article 98(2), national experts from third countries and international organisations participating in the work of the Agency. Those experts shall have security clearance appropriate to the classification of the information they handle, pursuant to Article 43(2). The Staff Regulations and the Conditions of Employment shall not apply to such staff. CHAPTER V Other provisions Article 91 Privileges and immunities Protocol No 7 on the Privileges and Immunities of the European Union annexed to the TEU and to the TFEU shall apply to the Agency and its staff. Article 92 Headquarters agreement and local offices hosting agreements 1. Necessary arrangements concerning the accommodation to be provided for the Agency in the host Member State where the seat of the Agency is located and the facilities to be made available by that Member State together with the specific rules applicable in the host Member State to the Executive Director, members of the Administrative Board, Agency staff and members of their families shall be laid down in a headquarters agreement. The headquarters agreement shall be concluded between the Agency and the Member State concerned where the seat of the Agency is located, after obtaining the approval of the Administrative Board. 2. Where necessary for the operation of a local office of the Agency, established in accordance with Article 79(2), a hosting agreement between the Agency and the Member State concerned where the local office is located shall be concluded after obtaining the approval of the Administrative Board. 3. The Agency\u2019s host Member States shall provide the best possible conditions to ensure the smooth and efficient functioning of the Agency, including multilingual, European-oriented schooling and appropriate transport connections. Article 93 Linguistic arrangements for the Agency 1. Council Regulation No 1 (48) shall apply to the Agency. 2. The translation services required for the functioning of the Agency shall be provided by the Translation Centre for the Bodies of the European Union. Article 94 Policy on access to documents held by the Agency 1. Regulation (EC) No 1049/2001 shall apply to documents held by the Agency. 2. The Administrative Board shall adopt arrangements for implementing Regulation (EC) No 1049/2001. 3. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the Ombudsman or an action before the Court of Justice of the European Union, under Articles 228 and 263 TFEU respectively. Article 95 Fraud prevention by the Agency 1. In order to facilitate combating fraud, corruption and other unlawful activities under Regulation (EU, Euratom) No 883/2013, the Agency shall, within six months from the day it becomes operational, accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by the European Anti-fraud Office (OLAF) (49) and adopt appropriate provisions applicable to all employees of the Agency using the model decision set out in the Annex to that Agreement. 2. The European Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over all grant beneficiaries, contractors and subcontractors that have received Union funds from the Agency. 3. OLAF may carry out investigations, including on-the-spot checks and inspections with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant or a contract funded by the Agency, in accordance with the provisions and procedures laid down in Regulation (Euratom, EC) No 2185/96 and in Regulation (EU, Euratom) No 883/2013. 4. Cooperation agreements with third countries and international organisations, contracts, grant agreements and grant decisions of the Agency shall contain provisions expressly empowering the European Court of Auditors and OLAF to conduct such audits and investigations, according to their respective competences. This shall not affect paragraphs 1, 2 and 3. Article 96 Protection of EUCI or sensitive non-classified information by the Agency The Agency shall, subject to prior consultation of the Commission, adopt its own security rules equivalent to the Commission\u2019s security rules for protecting EUCI and sensitive non-classified information, including rules concerning the exchange, processing and storage of such information, in accordance with Decisions (EU, Euratom) 2015/443 and (EU, Euratom) 2015/444. Article 97 Liability of the Agency 1. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. 2. The Court of Justice of the European Union shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by the Agency. 3. In the event of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its departments or by its servants in the performance of their duties. 4. The Court of Justice of the European Union shall have jurisdiction in disputes over compensation for the damage referred to in paragraph 3. 5. The personal liability of its servants towards the Agency shall be governed by the provisions laid down in the Staff Regulations or Conditions of Employment applicable to them. Article 98 Cooperation with third countries and international organisations 1. The Agency shall be open to the participation of third countries and international organisations that have entered into international agreements with the Union to this effect. 2. Under the relevant provisions of the agreements referred to in paragraph 1 of this Article and in Article 43, arrangements shall be developed specifying, in particular, the nature, extent and manner in which the third countries and international organisations concerned are to participate in the work of the Agency, including provisions relating to participation in the initiatives undertaken by the Agency, financial contributions and staff. As regards staff matters, those arrangements shall, in any event, comply with the Staff Regulations. When relevant, they shall also include provisions on the exchange and protection of classified information with third countries and international organisations. Those provisions shall be subject to the Commission\u2019s prior approval. 3. The Administrative Board shall adopt a strategy on relations with third countries and international organisations, in the framework of the international agreements referred to in paragraph 1, concerning matters for which the Agency is competent. 4. The Commission shall ensure that, in its relations with third countries and international organisations, the Agency acts within its mandate and the existing institutional framework by concluding an appropriate working arrangement with the Executive Director. Article 99 Conflicts of interest 1. Members of the Administrative Board and of the Security Accreditation Board, the Executive Director, seconded national experts and observers shall make a declaration of commitments and a declaration of interests indicating the absence or existence of any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be: (a) accurate and complete; (b) made in writing upon the entry into service of the persons concerned; (c) renewed annually; and (d) updated whenever necessary, in particular in the event of relevant changes in the personal circumstances of the persons concerned. 2. Before any meeting which they are to attend, members of the Administrative Board and of the Security Accreditation Board, the Executive Director, seconded national experts, observers and external experts participating in ad hoc working groups shall accurately and completely declare the absence or existence of any interest which might be considered prejudicial to their independence in relation to any items on the agenda, and, if such an interest exists, shall abstain from participating in the discussion of and from voting upon such points. 3. The Administrative Board and the Security Accreditation Board shall lay down, in their rules of procedure, the practical arrangements for the rules on declaration of interest referred to in paragraphs 1 and 2 and for the prevention and management of conflicts of interest. TITLE X PROGRAMMING, MONITORING, EVALUATION AND CONTROL Article 100 Work programme The Programme shall be implemented by the work programmes referred to in Article 110 of the Financial Regulation, which shall be specific and fully separate work programmes for each of the Programme\u2019s components. Work programmes shall set out the actions and associated budget required to meet the objectives of the Programme and, where applicable, the overall amount reserved for blending operations. The Commission shall adopt work programmes by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 101 Monitoring and reporting 1. Indicators to report on progress of the Programme towards the achievement of the general and specific objectives laid down in Article 4 are set out in the Annex. 2. To ensure the effective assessment of the Programme\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 105, to amend the Annex with regard to the indicators where considered necessary as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 3. Where imperative grounds of urgency so require, the procedure provided for in Article 106 shall apply to delegated acts adopted pursuant to this Article. 4. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively, and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where appropriate, on Member States. 5. For the purposes of paragraph 1, the recipients of Union funds shall provide appropriate information. The data necessary for the verification of the performance shall be collected in an efficient, effective and timely manner. Article 102 Evaluation 1. The Commission shall carry out evaluations of the Programme in a timely manner to feed into the decision-making process. 2. By 30 June 2024, and every four years thereafter, the Commission shall evaluate the implementation of the Programme. The evaluation shall cover all of the Programme\u2019s components and actions. It shall assess: (a) the performance of the services provided under the Programme; (b) the evolution of needs of the users of the Programme; and (c) when evaluating the implementation of SSA and GOVSATCOM, the evolution of available capacities for sharing and pooling, or, when evaluating the implementation of Galileo, Copernicus and EGNOS, the evolution of data and services offered by competitors. For each of the Programme\u2019s components, the evaluation shall, on the basis of a cost-benefit analysis, also assess the impact of the evolutions referred to in point (c) of the first subparagraph, including the need for changing the pricing policy or the need for additional space or ground infrastructure. If necessary, the evaluation shall be accompanied by an appropriate proposal. 3. The Commission shall communicate the conclusions of the evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. 4. The entities involved in the implementation of this Regulation shall provide the Commission with the data and information necessary for the evaluation referred to in paragraph 1. 5. By 30 June 2024, and every four years thereafter, the Commission shall assess the Agency\u2019s performance, in relation to its objectives, mandate, and tasks, in accordance with Commission guidelines. The evaluation shall be based on a cost-benefit analysis. The evaluation shall, in particular, address the possible need to modify the mandate of the Agency and the financial implications of any such modification. It shall also address the Agency\u2019s policy on conflicts of interest and the independence and autonomy of the Security Accreditation Board. The Commission may also evaluate the Agency\u2019s performance to assess the possibility to entrust it with additional tasks, in accordance with Article 29(3). If necessary, the evaluation shall be accompanied by an appropriate proposal. Where the Commission considers that there are no longer grounds for the Agency to continue pursuing its activities, given its objectives, mandate and tasks, it may propose to amend this Regulation accordingly. The Commission shall submit a report on the evaluation of the Agency and its conclusions to the European Parliament, the Council, the Administrative Board and the Security Accreditation Board of the Agency. The findings of the evaluation shall be made public. Article 103 Audits Audits on the use of the Union contribution carried out by persons or entities, including by others than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. Article 104 Personal data and privacy protection 1. All personal data handled in the context of the tasks and activities provided for in this Regulation, including by the Agency, shall be processed in accordance with the applicable law on personal data protection, in particular Regulations (EU) 2016/679 (50) and (EU) 2018/1725 (51) of the European Parliament and of the Council. 2. The Administrative Board shall establish measures for the application of Regulation (EU) 2018/1725 by the Agency, including those concerning the appointment of a Data Protection Officer of the Agency. Those measures shall be established after consultation of the European Data Protection Supervisor. TITLE XI DELEGATION AND IMPLEMENTING MEASURES Article 105 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 53 and 101 shall be conferred on the Commission until 31 December 2028. 3. The delegation of power referred to in Articles 53 and 101 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 53 and 101 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 106 Urgency procedure 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 105(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council. Article 107 Committee procedure 1. The Commission shall be assisted by the Programme committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. The Programme committee shall meet in specific different configurations as follows: (a) Galileo and EGNOS; (b) Copernicus; (c) SSA; (d) GOVSATCOM; (e) Security configuration: all security aspects of the Programme, without prejudice to the role of the Security Accreditation Board; representatives of ESA and the Agency may be invited to participate as observers; the EEAS shall also be invited to assist; (f) Horizontal configuration: strategic overview of the implementation of the Programme, coherence across the Programme\u2019s different components, cross-cutting measures and budget reallocation as referred to in Article 11. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where the Programme committee delivers no opinion on the draft implementing act referred to in Article 34(2) of this Regulation, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 5. In accordance with international agreements concluded by the Union, representatives of third countries or international organisations may be invited as observers in the meetings of the Programme committee under the conditions laid down in its rules of procedure, taking into account the security of the Union. 6. The Programme committee shall, in accordance with its rules of procedure, set up the \u2018User Forum\u2019, as a working group to advise the Programme committee on user requirements aspects, evolution of the services and user uptake. The User Forum shall aim to guarantee a continuous and effective involvement of users and meet in specific configurations for each of the Programme\u2019s components. TITLE XII TRANSITIONAL AND FINAL PROVISIONS Article 108 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the Programme, to actions taken pursuant to the Programme and to the results obtained. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 4. 3. The Agency may engage in communication activities on its own initiative within its field of competence. The allocation of resources to communication activities shall not be detrimental to the effective exercise of the tasks referred to in Article 29. Such communication activities shall be carried out in accordance with relevant communication and dissemination plans adopted by the Administrative Board. Article 109 Repeals 1. Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU are repealed with effect from 1 January 2021. 2. References to the repealed acts shall be construed as references to this Regulation. Article 110 Transitional provisions and continuity of services after 2027 1. This Regulation shall not affect the continuation or modification of the actions initiated pursuant to Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014, and Decision No 541/2014/EU, which shall continue to apply to those actions until their closure. In particular, the Consortium established under Article 7(3) of Decision No 541/2014/EU shall provide SST services until three months after the signature by the Constituting National Entities of the SST partnership agreement provided for in Article 58 of this Regulation. 2. The financial envelope for the Programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted pursuant to Regulations (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU. 3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses necessary to fulfil the objectives provided for in Article 4, to enable the management of actions not completed by the end of the Programme, as well as expenses covering critical operational activities and services provision, including through the FFPA and contribution agreements. Article 111 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 28 April 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and position of the Council at first reading of 19 April 2021 (not yet published in the Official Journal). Position of the European Parliament of 28 April 2021 (not yet published in the Official Journal). (2) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (3) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (see page 1 of this Official Journal). (4) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (5) Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 (see page 149 of this Official Journal). (6) OJ L 433 I, 22.12.2020, p. 28. (7) OJ L 282, 19.10.2016, p. 4. (8) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (\u2018Overseas Association Decision\u2019) (OJ L 344, 19.12.2013, p. 1). (9) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999, (OJ L 248, 18.9.2013, p. 1). (10) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.95, p. 1). (11) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (12) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (13) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (14) OJ L 1, 3.1.1994, p. 3. (15) Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, p. 7). (16) Regulation (EU) No 912/2010 of the European Parliament and of the Council of 22 September 2010 setting up the European GNSS Agency, repealing Council Regulation (EC) No 1321/2004 on the establishment of structures for the management of the European satellite radio navigation programmes and amending Regulation (EC) No 683/2008 of the European Parliament and of the Council (OJ L 276, 20.10.2010, p. 11). (17) OJ L 261, 6.8.2004, p. 64. (18) Decision No 541/2014/EU of the European Parliament and of the Council of 16 April 2014 establishing a Framework for Space Surveillance and Tracking Support (OJ L 158, 27.5.2014, p. 227). (19) Council Decision (CFSP) 2021/698 of 30 April 2021 on the security of systems and services deployed, operated and used under the Union Space Programme which may affect the security of the Union, and repealing Decision 2014/496/CFSP (see page 178 of this Official Journal). (20) Council Decision of 26 July 2010 establishing the organisation and functioning of the European External Action Service (2010/427/EU) (OJ L 201, 3.8.2010, p. 30). (21) Council Decision of 23 September 2013 on the security rules for protecting EU classified information (2013/488/EU) (OJ L 274, 15.10.2013, p. 1). (22) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (23) Regulation (EU) 2019/452 of the European Parliament and of the Council of 19 March 2019 establishing a framework for the screening of foreign direct investments into the Union (OJ L 79 I, 21.3.2019, p. 1). (24) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1). (25) Regulation (EU) No 1285/2013 of the European Parliament and of the Council of 11 December 2013 on the implementation and exploitation of European satellite navigation systems and repealing Council Regulation (EC) No 876/2002 and Regulation (EC) No 683/2008 of the European Parliament and of the Council (OJ L 347, 20.12.2013, p. 1). (26) Commission Implementing Decision (EU) 2017/224 of 8 February 2017 setting out the technical and operational specifications allowing the commercial service offered by the system established under the Galileo programme to fulfil the function referred to in Article 2(4)(c) of Regulation (EU) No 1285/2013 of the European Parliament and of the Council (OJ L 34, 9.2.2017, p. 36). (27) Regulation (EU) No 377/2014 of the European Parliament and of the Council of 3 April 2014 establishing the Copernicus Programme and repealing Regulation (EU) No 911/2010 (OJ L 122, 24.4.2014, p. 44). (28) Regulation (EU) No 911/2010 of the European Parliament and of the Council of 22 September 2010 on the European Earth monitoring programme (GMES) and its initial operations (2011 to 2013) (OJ L 276, 20.10.2010, p. 1). (29) Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1). (30) Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (OJ L 345, 31.12.2003, p. 90). (31) Commission Delegated Regulation (EU) No 1159/2013 of 12 July 2013 supplementing Regulation (EU) No 911/2010 of the European Parliament and of the Council on the European Earth monitoring programme (GMES) by establishing registration and licensing conditions for GMES users and defining criteria for restricting access to GMES dedicated data and GMES service information (OJ L 309, 19.11.2013, p. 1). (32) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (33) Decision taken by common accord between the Representatives of the Governments of the Member States of 10 December 2010 on the location of the seat of the European GNSS Agency (2010/803/EU) (OJ L 342, 28.12.2010, p. 15). (34) Commission Implementing Decision (EU) 2016/413 of 18 March 2016 determining the location of the ground-based infrastructure of the system established under the Galileo programme and setting out the necessary measures to ensure that it functions smoothly, and repealing Implementing Decision 2012/117/EU (OJ L 74, 19.3.2016, p. 45). (35) OJ L 123, 12.5.2016, p. 1. (36) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (37) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security on the Commission (OJ L 72, 17.3.2015, p. 41). (38) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, p.1). (39) Decision No 1104/2011/EU of the European Parliament and of the Council of 25 October 2011 on the rules for access to the public regulated service provided by the global navigation satellite system established under the Galileo programme (OJ L 287, 4.11.2011, p. 1). (40) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (41) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (42) Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (OJ L 216, 20.8.2009, p. 76). (43) Commission Delegated Decision of 15.9.2015 supplementing Decision No 1104/2011/EU of the European Parliament and of the Council as regards the common minimum standards to be complied with by the competent PRS authorities C(2015) 6123. (44) Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection (OJ L 345, 23.12.2008, p. 75). (45) Commission Implementing Decision (EU) 2017/1406 of 31 July 2017 determining the location of the ground-based infrastructure of the EGNOS system (OJ L 200, 1.8.2017, p. 4). (46) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (47) OJ L 56, 4.3.1968, p. 1. (48) Council Regulation No 1 of 15 April 1958 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). (49) OJ L 136, 31.5.1999, p. 15. (50) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (51) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). ANNEX KEY INDICATORS Key indicators shall structure the monitoring of the Programme performance towards its objectives referred to in Article 4, with a view to minimising administrative burdens and costs. 1. To that end, for annual reporting, data shall be collected as regards the following set of key indicators for which implementation details, such as metrics, figures and associated nominal values and thresholds, including quantitative data and qualitative case studies, according to applicable mission requirements and expected performance, shall be defined in the agreements concluded with the entrusted entities: 1.1. Specific objective referred to in point (a) of Article 4(2) Indicator 1: Accuracy of navigation and timing services provided by Galileo and EGNOS separately Indicator 2: Availability and continuity of services provided by Galileo and EGNOS separately Indicator 3: EGNOS services geographical coverage and number of EGNOS procedures published (both APV-I and LPV-200) Indicator 4: Union user satisfaction with respect to Galileo and EGNOS services Indicator 5: Share of Galileo and EGNOS enabled receivers in the worldwide and the EU Global Navigation Satellite Systems/ Satellite Based Augmentation System (GNSS/SBAS) receivers market. 1.2. Specific objective referred to in point (b) of Article 4(2) Indicator 1: Number of Union users of Copernicus Services, Copernicus data, and Data and Information Access Services (DIAS) providing, where possible, information such as the type of user, geographical distribution and sector of activity Indicator 2: Where applicable, number of activations of Copernicus Services requested or served Indicator 3: Union user satisfaction with respect to Copernicus Services and DIAS Indicator 4: Reliability, availability and continuity of the Copernicus Services and Copernicus data stream Indicator 5: Number of new information products delivered in the portfolio of each Copernicus Service Indicator 6: Amount of data generated by the Copernicus Sentinels 1.3. Specific objective referred to in point (c) of Article 4(2) Indicator 1: Number of users of SSA component providing, where possible, information such as the type of user, geographical distribution and sector of activity Indicator 2: Availability of Services 1.4. Specific objective referred to in point (d) of Article 4(2) Indicator 1: Number of GOVSATCOM users providing, where possible, information such as the type of user, geographical distribution and sector of activity Indicator 2: Availability of Services 1.5. Specific objective referred to in point (e) of Article 4(2) Indicator 1: Number of launches for the Programme (including numbers by type of launchers) 1.6. Specific objective referred to in point (f) of Article 4(2) Indicator 1: Number and location of space hubs in the Union Indicator 2: Share of SMEs established in the Union as a proportion of the total value of the contracts relating to the Programme 2. The evaluation referred to in Article 102 shall take into account additional elements such as: 2.1. Performance of competitors in the areas of navigation and Earth observation 2.2. User uptake of Galileo and EGNOS services 2.3. Integrity of EGNOS services 2.4. Uptake of Copernicus Services by Copernicus core users 2.5. Number of Union or Member State policies exploiting or benefiting from Copernicus 2.6. Analysis of the autonomy of the SST sub-component and of the level of independence of the Union in this area 2.7. State-of-play of networking for the activities of NEO sub-component 2.8. Assessment of GOVSATCOM capacities as regards user needs as referred to in Articles 69 and 102 2.9. User satisfaction of the SSA and GOVSATCOM services 2.10. Share of Ariane and Vega launches in the total market based on publicly available data 2.11. Development of the downstream sector measured, when available, by the number of new companies using Union space data, information and services, jobs created and turnover, by Member State, using surveys of the Commission (Eurostat) when available 2.12. Development of the Union space upstream sector measured, when available, by number of jobs created and turnover by Member State and the global market share of European space industry, using surveys of the Commission (Eurostat) when available", "summary": "EU space programme (2021\u20132027) \u2013 European Union Agency for the Space Programme EU space programme (2021\u20132027) \u2013 European Union Agency for the Space Programme SUMMARY OF: Regulation (EU) 2021/696 establishing the EU space programme and the European Union Agency for the Space Programme Decision (CFSP) 2021/698 on the security of systems and services deployed, operated and used under the Union Space Programme which may affect the security of the EU WHAT IS THE AIM OF THE REGULATION AND THE DECISION? Regulation (EU) 2021/696 sets up the European space programme for the 2021\u20132027 period and the EU Agency for the Space Programme (EUSPA). The programme aims to preserve European Union (EU) leadership in space, to ensure that the EU remains competitive in the new space economy and to tackle some of the most pressing challenges today, such as fighting climate change and stimulating technological innovation. Decision (CFSP) 2021/698 sets out the responsibilities of the Council of the European Union and the High Representative of the Union for Foreign Affairs and Security Policy concerning threats to EU security stemming from the systems and services established under the EU space programme. KEY POINTS Objectives The main objectives of the EU space programme are to: provide or contribute to the provision of uninterrupted, high-quality, up-to-date and, where appropriate, secure space-related data, information and services that can meet existing and future needs and support the EU\u2019s political priorities; maximise socio-economic benefits to enable growth and job creation, and promote the widest possible uptake and use of the data, information and services provided by the programme\u2019s components both within and outside the EU, while ensuring synergies and complementarity with the Horizon Europe programme (Regulation (EU) 2021/695 \u2013 see summary); enhance the safety and security of the EU and the EU Member States and reinforce EU autonomy, in particular in terms of technology; promote the EU\u2019s role as a global actor in the space sector, encourage international cooperation, reinforce EU space diplomacy and strengthen its role in tackling global challenges, supporting global initiatives and raising awareness of space as a common heritage of humankind; enhance the safety, security and sustainability of all outer space activities pertaining to space objects and debris proliferation, as well as the space environment. The regulation also sets out a number of specific objectives, including: to provide long-term, state-of-the-art and secure positioning, navigation and timing services, while ensuring service continuity and robustness, via Galileo and the European geostationary navigation overlay service (EGNOS); to deliver accurate and reliable Earth observation data, information and services integrating other data sources on a long-term sustainable basis via Copernicus, in order to support the formulation, implementation and monitoring of the EU and its Member States\u2019 policies and actions based on user requirements; to enhance capabilities to monitor, track and identify space objects and space debris through space surveillance and awareness, including three sub-components \u2013 space objects surveillance and tracking, space weather phenomena and near-Earth objects; to ensure the long-term availability of reliable, secure and cost-effective satellite communications services for users of the EU governmental satellite communications programme (GOVSATCOM); to support an autonomous, secure and cost-efficient capability to access space, taking into account the essential security interests of the EU; to foster the development of a strong EU space economy, including by reinforcing competitiveness, innovation, entrepreneurship, skills and capacity building in all Member States and EU regions, with particular regard to small and medium-sized enterprises and start-ups. Governance The regulation establishes the EU Agency for the Space Programme (EUSPA), which replaces and expands the European Agency for Global Navigation Satellite Systems. It also streamlines governance by assigning clear tasks to the various actors: the European Commission, the institution mainly in charge of the programme;, EUSPA (the operational manager of Galileo, EGNOS, and the security and development of downstream applications for all components of the space programme); and the European Space Agency (research and development). Funding The programme runs for the period of the 2021\u20132027 multiannual financial framework. It has a budget of \u20ac14,8 billion. The regulation lays down the forms of EU funding, the rules for granting such funding and the rules for implementing the programme. FROM WHEN DO THE REGULATION AND DECISION APPLY? The regulation and decision have applied since 1 January 2021. BACKGROUND For further information, see: The space policy of the European Union (European Commission) The EU space programme (European Commission) Copernicus (website) Copernicus (European Commission) Galileo (summary) Galileo (European Commission) European geostationary navigation overlay service (EGNOS) (European Commission) EU governmental satellite communications programme (GOVSATCOM) (European Commission) MAIN DOCUMENTS Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU (OJ L 170, 12.5.2021, pp. 69\u2013148). Council Decision (CFSP) 2021/698 of 30 April 2021 on the security of systems and services deployed, operated and used under the Union Space Programme which may affect the security of the Union, and repealing Decision 2014/496/CFSP (OJ L 170, 12.5.2021, pp. 178\u2013182). RELATED DOCUMENTS Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1\u201368). Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, pp. 11\u201322). last update 20.10.2021"}
{"article": "11.5.2021 EN Official Journal of the European Union L 166/1 REGULATION (EU) 2021/694 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 172 and Article 173(3) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) This Regulation lays down a financial envelope for the Digital Europe Programme (the \u2018Programme\u2019) for the period 2021-2027, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (4), for the European Parliament and for the Council during the annual budgetary procedure. (2) The Programme should be established for a period of seven years to align its duration with that of the multiannual financial framework laid down in Council Regulation (EU, Euratom) 2020/2093 (5) (MFF 2021-2027). (3) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (6) (the \u2018Financial Regulation\u2019) applies to the Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (4) In accordance with Article 193(2) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to the interests of the Union, it should be possible to provide in the financing decision, during a limited period of time at the beginning of the MFF 2021-2027, and only in duly justified cases, for the eligibility of activities and underlying costs from the beginning of the 2021 financial year, even if they were implemented and incurred before the grant application was submitted. (5) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (7) and Council Regulations (EC, Euratom) No 2988/95 (8), (Euratom, EC) No 2185/96 (9) and (EU) 2017/1939 (10), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union, as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (11). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of the Union funds grant equivalent rights. (6) Pursuant to Council Decision 2013/755/EU (12), persons and entities established in overseas countries and territories should be eligible for funding subject to the rules and objectives of the Programme and to possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. The effectiveness of their participation in the Programme should be monitored and regularly evaluated by the Commission. (7) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13), the Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements that correspond to existing needs and comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (14), while avoiding an administrative burden, in particular on Member States, and overregulation, and taking into account existing measuring and benchmarking frameworks in the digital field. Those requirements, where appropriate, should include measurable quantitative and qualitative indicators as a basis for evaluating the effects of the Programme on the ground. (8) The Programme should ensure utmost transparency and accountability of innovative financial instruments and mechanisms that involve the Union budget, with respect to their contribution towards achieving Union objectives, both as regards initial expectations and the end results. (9) The Tallinn Digital Summit of September 2017 and the Conclusions of the European Council of 19 October 2017 indicated the need for the Union to invest in digitising its economies and addressing the skills gap to maintain and enrich European competitiveness and innovation, quality of life and social fabric. The European Council concluded that digital transformation offers immense opportunities for innovation, growth and jobs, will contribute to our global competitiveness, and will enhance creative and cultural diversity. Seizing those opportunities requires collectively tackling some of the challenges posed by the digital transformation and reviewing policies affected by the digital transformation. (10) The European Council concluded in particular that the Union should urgently address emerging trends, including issues such as artificial intelligence (AI) and distributed ledger technologies (e.g. blockchain), while at the same time ensuring a high level of data protection in full compliance with Regulation (EU) 2016/679, digital rights, fundamental rights and ethical standards. The European Council invited the Commission to put forward a European approach to AI by early 2018 and called on the Commission to put forward the necessary initiatives to strengthen the framework conditions with a view to enabling the Union to explore new markets through risk-based radical innovations and to reaffirming the leading role of its industry. (11) Building a strong European digital economy and society would be enhanced by the proper implementation of the Connecting Europe Facility established by a Regulation of the European Parliament and of the Council and the European Electronic Communications Code established by Directive (EU) 2018/1972 of the European Parliament and of the Council (15). (12) In its communication of 14 February 2018, entitled \u2018A new, modern Multiannual Financial Framework for a European Union that delivers efficiently on its priorities post-2020\u2019, the Commission, taking into consideration the options for the new multiannual financial framework, outlines a programme for Europe\u2019s digital transformations to deliver strong progress towards smart growth in areas such as high-quality data infrastructure, connectivity and cybersecurity. The Programme would seek to secure European leadership in supercomputing, next generation internet, AI, robotics and big data. It would reinforce the competitive position of industry and business in Europe across the digitised economy and would have a significant impact on bridging and filling the skills gap across the Union so that citizens have the necessary skills and knowledge to face the digital transformation. (13) The Commission communication of 25 April 2018, entitled \u2018Towards a common European data space\u2019, addresses the new measures to be taken as a key step towards a common data space in the Union, a seamless digital area with a scale that will enable the development and innovation of new products and services based on data. (14) The general objectives of the Programme should be to support the digital transformation of industry and to foster better exploitation of the industrial potential of policies on innovation, research and technological development, for the benefit of citizens and businesses across the Union, including its outermost regions and its economically disadvantaged regions. The Programme should be structured into five specific objectives that reflect key policy areas, namely: High Performance Computing; Artificial Intelligence; Cybersecurity and Trust; Advanced Digital Skills; and Deployment and Best Use of Digital Capacities and Interoperability. For all those key policy areas, the Programme should also aim to better align Union, Member State and regional policies, and to pool private and industrial resources in order to increase investment and develop stronger synergies. In addition, the Programme should strengthen the Union\u2019s competiveness and the resilience of its economy. (15) The five specific objectives are distinct but interdependent. For example, AI needs cybersecurity to be trustworthy, high performance computing (HPC) capabilities are key for supporting learning in the context of AI, and all three capacities require advanced digital skills. Although individual actions under the Programme relate to a single specific objective, the objectives should not be viewed in isolation, but rather as forming the core of a coherent package. (16) There is a need to support small and medium-sized enterprises (SMEs) that intend to harness the digital transformation in their production processes. Such support would allow SMEs to contribute to the growth of the European economy through an efficient use of resources. (17) A central role in the implementation of the Programme should be attributed to European Digital Innovation Hubs, which should stimulate the broad adoption of advanced digital technologies by industry, in particular by SMEs and by other entities that employ up to 3 000 people (mid-caps), by public organisations and by the academic community. In order to clarify the distinction between digital innovation hubs that comply with the eligibility criteria under the Programme and digital innovation hubs established following the Commission communication of 19 April 2016 entitled \u2018Digitising European Industry \u2013 Reaping the full benefits of a Digital Single Market\u2019 and financed by other sources, the hubs financed under the Programme should be called European Digital Innovation Hubs. European Digital Innovation Hubs should serve as access points for the latest digital capacities, including HPC, AI, cybersecurity, as well as for other existing innovative technologies such as key enabling technologies, available also in fablabs or citylabs. European Digital Innovation Hubs should act as single-entry points in accessing tested and validated technologies and should promote open innovation. They should also provide support in the area of advanced digital skills, for example by coordinating with education providers for the provision of short-term training for workers and internships for students. The network of European Digital Innovation Hubs should ensure broad geographical coverage across Europe and should contribute to the participation of the outermost regions in the Digital Single Market. (18) During the first year of the Programme, an initial network of European Digital Innovation Hubs should be established through an open and competitive process from among entities designated by Member States. To that end, Member States should be free to propose candidates in accordance with their national procedures and national administrative and institutional structures. The Commission should take the utmost account of the opinion of each Member State before selecting a European Digital Innovation Hub in the territory of that Member State. Entities which already carry out functions as digital innovation hubs in the context of the Digitising European Industry Initiative could be designated by Member States as candidates as a result of an open and competitive process. The Commission should be able to involve independent external experts in the selection process. The Commission and the Member States should avoid the unnecessary duplication of competences and functions at Union and national level. There should therefore be adequate flexibility when designating the hubs and determining their activities and composition. In order to ensure a broad geographical coverage across Europe, as well as a balance of coverage of technologies and sectors, the network might be further enlarged through a subsequent open and competitive process. (19) European Digital Innovation Hubs should develop appropriate synergies with relevant actions funded by Horizon Europe \u2013 the Framework Programme for Research and Innovation established by Regulation (EU) 2021/695 of the European Parliament and of the Council (16) (Horizon Europe) or by other research and innovation programmes, with the European Institute of Innovation and Technology (EIT) established by a Regulation of the European Parliament and of the Council, in particular its Knowledge and Innovation Communities (KICs), as well as with established networks such as the Entreprise Europe Network, or the InvestEU Advisory Hub established in accordance with Regulation (EU) 2021/523 of the European Parliament and of the Council (17). (20) European Digital Innovation Hubs should act as facilitators to bring together industries, businesses and public administrations which are in need of new technological solutions, with businesses, in particular start-ups and SMEs, that have market-ready solutions. (21) A consortium of legal entities may be selected as European Digital Innovation Hubs in accordance with point (c) of Article 197(2) of the Financial Regulation that allows entities which do not have legal personality under the applicable national law to participate in calls for proposals, provided that their representatives have the capacity to undertake legal obligations on behalf of those entities and that those entities offer guarantees for the protection of the financial interests of the Union that are equivalent to those offered by legal persons. (22) European Digital Innovation Hubs should be allowed to receive contributions from Member States and participating third countries, including from public authorities within Member States and those third countries, contributions from international bodies or institutions, and contributions from the private sector, in particular from members, shareholders or partners of the European Digital Innovation Hubs. European Digital Innovation Hubs should also be allowed to receive revenues generated by the European Digital Innovation Hubs\u2019 own assets and activities, bequests, donations and contributions from individuals and funding from the Programme and other Union programmes, including in the form of grants. (23) The Programme should be implemented through projects that reinforce and widen the use of essential digital capacities. Such implementation should involve co-financing with Member States and, where necessary, the private sector. The co-financing rate should be established in the work programme. By way of derogation from the general rule, the Union funding should be able to cover up to 100 % of eligible costs. In particular, such financing should require reaching a critical mass in procurement to obtain better value for money and to guarantee that suppliers in Europe stay at the forefront of technology advancements. (24) The policy objectives of the Programme should also be addressed through financial instruments and budgetary guarantees under the InvestEU Programme established by Regulation (EU) 2021/523. (25) The Programme\u2019s actions should be used to improve further the Union\u2019s digital capacities and to address market failures or sub-optimal investment situations, in a proportionate manner, without duplicating or crowding out private financing, and should provide clear European added value. (26) In order to achieve maximum flexibility throughout the lifetime of the Programme and to develop synergies between the components of the Programme, it should be possible for each of the specific objectives to be implemented through any of the instruments available under the Financial Regulation. The delivery mechanisms to be used are direct management and indirect management, where Union financing should be combined with other sources of financing or where execution requires the setup of commonly governed structures. Moreover, in order to respond in particular to new developments and needs such as new technologies, the Commission is allowed to propose to deviate from the indicative amounts set out in this Regulation in the context of the annual budgetary procedure and in accordance with the Financial Regulation. (27) In order to ensure the efficient allocation of funds from the Union budget, it is necessary to ensure the European added value of all actions and activities carried out under the Programme and their complementarity with Member States\u2019 activities, while consistency, complementarity and synergies should be sought with funding programmes that support policy areas that are closely linked to each other. Although the relevant work programmes provide a tool for ensuring consistency for directly and indirectly managed actions, collaboration between the Commission and the relevant Member States authorities should be established to ensure consistency and complementarities between directly or indirectly managed funds and funds that are subject to shared management, while complying with the applicable provisions of a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the \u2018Common Provisions Regulation for 2021-2027\u2019). (28) The HPC capacities and the related data processing in the Union should ensure the wider use of HPC by industry and, more generally, in areas of public interest, in order to seize unique opportunities that supercomputers bring to society as regards health, environment and security, as well as to the competitiveness of industry, in particular SMEs. Acquiring world-class supercomputers would secure the Union\u2019s supply system and would help deploy services for simulation, visualisation and prototyping, while ensuring that HPC systems comply with Union values and principles. (29) The support for the Union\u2019s intervention in the HPC area was expressed by the European Parliament and by the Council. Moreover, between 2017 and 2018, 22 Member States signed the European Declaration on HPC, a multi-government agreement in which they committed to collaborating with the Commission to build and deploy state-of-the-art HPC infrastructures and data infrastructures in Europe that would be available to scientific communities and to public and private partners across the Union. (30) As highlighted in the impact assessment accompanying the Commission proposal for a Council Regulation establishing the European High Performance Computing Joint Undertaking, in order to achieve Specific Objective \u2018High Performance Computing\u2019, a joint undertaking is deemed to be the most suitable means of implementation, in particular to coordinate Union and national strategies and investments in HPC infrastructure, as well as research and development, pool resources from public and private funds, and safeguard the economic and strategic interests of the Union. Moreover, the national High Performance Computing competence centres within the meaning of the Council Regulation (EU) 2018/1488 (18) provide HPC services to industry, including SMEs and start-ups, the academic community and public administrations. (31) Developing capacity related to AI is a crucial driver for the digital transformation of industry, services and the public sector. Ever more autonomous robots are used in factories, deep sea applications, homes, cities and hospitals. Commercial AI platforms have moved from testing to having real applications in the health and environmental sectors. All major car manufacturers are developing self-driving cars, and machine-learning techniques are at the heart of all main web platforms and big data applications. It is essential for Europe to join forces at all levels to be competitive internationally. Member States have acknowledged this through concrete commitments for collaboration in a coordinated action plan. (32) Libraries of algorithms may cover a large set of algorithms, including simple solutions such as classification algorithms, neural network algorithms and planning or reasoning algorithms. They may also cover more complex solutions, such as speech recognition algorithms, navigation algorithms embedded in autonomous devices, such as drones or autonomous cars and AI algorithms built into robots to enable them to interact with and adapt to their environment. Libraries of algorithms should be made easily accessible to everyone on the basis of fair, reasonable and non-discriminatory terms. (33) In its resolution of 1 June 2017 on digitising European industry, the European Parliament pointed out the impact of language barriers on industry and on the digitisation of industry. In that context, the development of large-scale AI-based language technologies, such as automatic translation, speech recognition, big data text analytics, dialogue and question-answering systems, is essential to preserving linguistic diversity, ensuring inclusiveness and enabling human-to-human and human-to-machine communication. (34) Products and services based on AI should be user-friendly, should comply with the law by default and should provide consumers with more choice and more information, in particular regarding the quality of products and services. (35) The availability of large-scale data sets and of testing and experimentation facilities are of major importance to the development of AI, including language technologies. (36) In its resolution on digitising European industry, the European Parliament highlighted the importance of a common European cybersecurity approach and recognised the need to raise awareness. It considered cyber-resilience as a crucial responsibility for business leaders and national and European industrial and security policymakers, as well as the implementation of security and privacy by design and by default. (37) Cybersecurity is a challenge for the entire Union that cannot be addressed only by national initiatives. Europe\u2019s cybersecurity capacity should be reinforced to endow Europe with the necessary capacities to protect its citizens, public administrations and businesses from cyber threats. In addition, consumers should be protected when using connected products that can be hacked and can compromise their safety. Such protection should be achieved together with Member States and the private sector by developing projects to reinforce Europe\u2019s capacities in cybersecurity, by ensuring coordination between those projects and by ensuring the wide deployment of the latest cybersecurity solutions across the economy, including dual-use projects, services, competences and applications, as well as by aggregating competences in this field to ensure critical mass and excellence. (38) In September 2017, the Commission put forward a package of initiatives setting out a comprehensive Union approach to cybersecurity, with the aim of reinforcing Europe\u2019s capacity to deal with cyberattacks and cyber threats and to strengthen technology and industrial capacity in this field. That package includes Regulation (EU) 2019/881 of the European Parliament and of the Council (19). (39) Trust is a prerequisite for the Digital Single Market to function. Cybersecurity technologies such as digital identities, cryptography and intrusion detection, and their application in areas such as finance, industry 4.0, energy, transport, healthcare, and e-government are essential to safeguarding the security of, and trust in, online activities and transactions by citizens, public administrations, and businesses. (40) The European Council, in its conclusions of 19 October 2017, stressed that to successfully build a Digital Europe, the Union needs labour markets, training and education systems that are fit for the digital age and that there is a need to invest in digital skills to empower and enable all Europeans. (41) In its conclusions of 14 December 2017, the European Council called on Member States, the Council and the Commission to take forward the agenda of the Gothenburg Social Summit of November 2017, including the European Pillar of Social Rights, as well as education and training and the delivery of the new European Skills Agenda. The European Council also asked the Commission, the Council and the Member States to examine possible measures to address the skills challenges linked to digitisation, cybersecurity, media literacy and AI and to address the need for an inclusive, lifelong-learning-based and innovation-driven approach to education and training. In response, the Commission presented on 17 January 2018 a first package of measures, addressing key competences, digital skills, common values and inclusive education. In May 2018, a second package of measures was launched, advancing work to build a European Education Area by 2025, which also emphasises the centrality of digital skills. Media literacy includes essential competencies (knowledge, skills and attitudes) that allow citizens to engage effectively with media and other information providers and to develop critical thinking and lifelong learning skills for socialising and becoming active citizens. (42) Considering the need for a holistic approach, the Programme should also take into account inclusion, qualification, training and specialisation, which, in addition to advanced digital skills, are decisive for the creation of added value in the knowledge society. (43) In its resolution on digitising European industry, the European Parliament stated that education, training and lifelong learning are the cornerstone of social cohesion in a digital society. It further demanded that the gender balance perspective be incorporated in all digital initiatives, emphasising the need to address the gender gap within the information and communications technology (ICT) sector, since this is essential to Europe\u2019s long-term growth and prosperity. (44) The advanced digital technologies supported by the Programme, such as HPC, cybersecurity and AI, are now sufficiently mature to move beyond the research phase and be deployed, implemented and scaled-up at Union level. In the same way as the deployment of those technologies require a Union response, so does the advanced digital skills dimension. Training opportunities in advanced digital skills, including data protection competencies, need to be scaled up, increased and made accessible throughout the Union. Failing to do that could impede the smooth deployment of advanced digital technologies and could hamper the overall competitiveness of Union\u2019s economy. The actions supported by the Programme are complementary to those supported by the European Social Fund Plus (ESF+), the European Regional Development Fund (ERDF) and Erasmus+, each established by a Regulation of the European Parliament and of the Council, and Horizon Europe. Those actions will target the Union workforce in the private sector as well as the public sector, in particular ICT professionals and other related professionals, as well as students, trainees and trainers. The term \u2018workforce\u2019 refers to the economically active population, and includes both workers and self-employed people who are in occupation and unemployed people. (45) Modernising public administrations and services by digital means is crucial to reducing the administrative burden on businesses, including SMEs, and on citizens in general by making their interactions with public authorities faster, more convenient and less costly, as well as by increasing the efficiency, transparency and the quality of the services provided to citizens and businesses, while at the same time increasing the efficiency of public spending. Since a number of services of public interest already have a Union dimension, the support provided to their implementation and deployment at Union level should ensure that citizens and businesses will beable to benefit from access to high-quality digital services across the Union that are, where possible, multilingual. Moreover, Union support in this area is expected to encourage the re-use of public sector information. (46) Digitalisation can facilitate and improve barrier-free accessibility to all, including older people, people with reduced mobility or with disabilities, and people in remote or rural areas. (47) The digital transformation of areas of public interest such as healthcare, mobility, justice, earth or environmental monitoring, security, the reduction of carbon emissions, energy infrastructure, education and training, and culture requires the continuation and expansion of digital service infrastructures, which make possible the secure cross-border exchange of data and which foster national development. Coordination between those digital service infrastructures under this Regulation would best achieve the potential for exploiting synergies. (48) The deployment of the necessary digital technologies, in particular those under Specific Objectives \u2018High Performance Computing\u2019, \u2018Artificial Intelligence\u2019 and \u2018Cybersecurity and Trust\u2019, is key to reaping the benefits of digital transformation and might be complemented by other leading-edge and future technologies, such as distributed ledger technologies (e.g. blockchain). (49) The digital transformation should allow citizens to have access to, use and manage their personal data securely across borders, irrespective of their location or the location of the data. (50) In the Tallinn Declaration on eGovernment of 6 October 2017, the ministers in charge of eGovernment policy and coordination from the Member States and the countries which are members of the European Free Trade Association concluded that digital progress is transforming their societies and economies to the core, challenging the effectiveness of previously developed policies in a broad range of areas as well as the role and function of the public administration overall, and that it is their duty to anticipate and manage those challenges to meet the needs and expectations of citizens and businesses. (51) The modernisation of European public administrations is one of the key priorities for successful implementation of the Digital Single Market. The mid-term evaluation of the Digital Single Market strategy highlighted the need to strengthen the transformation of public administrations and to ensure citizens have easy, trusted, and seamless access to public services. (52) The Annual Growth Survey published by the Commission in 2017 shows that the quality of European public administrations has a direct impact on the economic environment and is therefore crucial to stimulating productivity, competitiveness, economic cooperation, sustainable growth, employment and high-quality jobs. In particular, efficient and transparent public administrations and effective justice systems are necessary to support economic growth and to deliver high-quality services to citizens and businesses. (53) The interoperability of European public services concerns all levels of administration: Union, national, regional and local. Besides removing barriers to a functioning internal market, interoperability facilitates cross-border cooperation, the promotion of European standards and the successful implementation of policies, and offers great potential for avoiding cross-border electronic barriers, further securing the emergence of new, and the consolidation of developing, common public services at Union level. In order to eliminate the fragmentation of European public services and to support fundamental freedoms and operational mutual recognition in the Union, a holistic cross-sector and cross-border approach to interoperability should be promoted in the manner that is most effective and is most responsive to end-users. Such an approach implies that interoperability is to be understood in a broad sense, spanning technical and legal layers and encompassing policy elements in the field. Accordingly, the span of activities would go beyond the usual lifecycle of solutions to include all the intervention elements that would support the necessary framework conditions for sustained interoperability at large. The Programme should also facilitate cross-fertilisation between different national initiatives, leading to the development of a digital society. (54) The Programme should encourage open-source solutions in order to allow reuse, increase trust and secure transparency. Such an approach will have a positive impact on the sustainability of funded projects. (55) The budget allocated to specific actions dedicated to the implementation of the interoperability framework and the interoperability of developed solutions is expected to be EUR 194 million. (56) The European Parliament\u2019s resolution on digitising European industry stressed the importance of unlocking sufficient public and private finance for the digitisation of Europe\u2019s industry. (57) On 19 April 2016, the Commission adopted the Digitising European Industry initiative to ensure that any industry in Europe, big or small, wherever situated and in any sector can fully benefit from digital innovations. This is of particular relevance to SMEs in the cultural and creative sectors. (58) The European Economic and Social Committee welcomed the Commission communication on Digitising European Industry and considered it, together with accompanying documents, as \u2018the first step in a vast European work programme to be carried out in close mutual cooperation between all interested public and private parties\u2019. (59) Reaching the target objectives may require leveraging the potential of complementary technologies in the networking and computing domains, as stated in the Commission communication on Digitising European Industry, which recognises the \u2018availability of world class networking and cloud infrastructure\u2019 as an essential component of the digitisation of industry. (60) By providing for a single set of rules directly applicable in the Member States legal orders, Regulation (EU) 2016/679 guarantees the free flow of personal data between Member States and reinforces trust and the security of individuals, two indispensable elements for a real Digital Single Market. All actions taken under the Programmewhich involve the processing of personal data should therefore contribute to the smooth implementation of that Regulation, for example in the field of AI and distributed ledger technologies (e.g. blockchain). Those actions should support the development of digital technologies that comply with the obligations on data protection by design and by default. (61) The Programme should be implemented in a manner that fully respects the Union and international framework of intellectual property protection and enforcement. The effective protection of intellectual property plays a key role in innovation and is, therefore, necessary for the effective implementation of the Programme. (62) Third countries which are members of the European Economic Area may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (20), which provides for the implementation of the programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. Those instruments should be able to provide for partial association, namely association to a limited number of specific objectives pursued under the Programme. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. (63) The bodies entrusted with the implementation of the Programme should comply with the provisions applicable to the Union institutions and with the national law regarding the handling of information, in particular sensitive non-classified information and EU classified information. For Specific Objective \u2018Cybersecurity and Trust\u2019, security reasons may require legal entities that are controlled from third countries to be excluded from calls for proposals and tenders under the Programme. In exceptional cases, such exclusions may also be required for Specific Objectives \u2018High Performance Computing\u2019 and \u2018Artificial Intelligence\u2019. The security reasons for such exclusions should be proportionate and should be duly justified by reference to the risks that the inclusion of such entities would represent. (64) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement, adopted under the United Nations Framework Convention on Climate Change (21), and to the United Nations Sustainable Development Goals, the Programme is intended to contribute to the mainstreaming of climate actions and to the achievement of an overall target of 30 % of the Union budget expenditure supporting climate objectives and the ambition of 7,5 % of the budget reflecting biodiversity expenditures in 2024 and 10 % in 2026 and 2027 while considering the existing overlaps between climate and biodiversity goals. Relevant actions should be identified during the Programme\u2019s preparation and implementation, and should be reassessed in the context of the relevant evaluations and review processes. (65) As the Programme is new, it is useful to provide, in an annex, a technical description of the Programme\u2019s scope of actions. That technical description included in such an annex should be taken into account by the Commission when preparing work programmes, whereas the work programmes should be consistent with the specific objectives set out in this Regulation. (66) The work programmes should be adopted in principle as multiannual work programmes, typically every two years, or, if justified by needs related to the implementation of the programme, as annual work programmes. The forms of Union funding and the methods of implementation of the Programme should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. That choice should include the consideration of the use of lump sums, flat-rate financing and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (67) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in order to amend Annex I to this Regulation to reflect technological change and market developments, with regard to the actions set out therein in a manner consistent with the objectives of this Regulation and to amend Annex II thereto with regard to the measurable indicators where considered to be necessary as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (68) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the selection of the entities forming the initial and additional European Digital Innovation Hubs and the adoption of the work programmes for Specific Objectives 2, 4 and 5 and for possible other actions under direct management for Specific Objectives 1 and 3 so that the objectives of the Programme are achieved in accordance with the Union and Member States\u2019 priorities while ensuring consistency, transparency and continuity of joint action by the Union and the Member States. Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (22). For actions subject to indirect management, the work programmes are adopted in accordance with rules of the governing boards of the bodies entrusted with the implementation of the Programme. (69) This Regulation respects fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019), in particular those regarding the protection of personal data, the freedom of expression and information, the freedom to conduct business, the prohibition of discrimination, healthcare, consumer protection and the right to effective remedy and fair trial. Member States should apply this Regulation in a manner consistent with those rights and principles. (70) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the Union budget through grants, prizes, procurement and indirect management, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (71) Since the objectives of this Regulation, namely to support and accelerate the digital transformation of the European economy, industry and society, to bring its benefits to citizens, public administrations and businesses across the Union, and to improve the competitiveness of Europe in the global digital economy while contributing to bridging the digital divide across the Union and reinforcing the Union\u2019s strategic autonomy, cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (72) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the MFF 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021. (73) Decision (EU) 2015/2240 of the European Parliament and of the Council (23) should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the Digital Europe Programme (the \u2018Programme\u2019) for the duration of the MFF 2021-2027. This Regulation lays down the objectives of the Programme, its budget for the period 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018blending operation\u2019 means an action supported by the Union budget, including within a blending facility or platform as defined in point (6) of Article 2 of the Financial Regulation, that combines non-repayable forms of support or financial instruments from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; (2) \u2018legal entity\u2019 means a natural person, or a legal person created and recognised as such under Union, national, or international law, which has legal personality and the capacity to act in its own name, exercise rights and be subject to obligations, or an entity which does not have legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (3) \u2018associated country\u2019 means a third country which is party to an agreement with the Union allowing for its participation in the Programme pursuant to Article 10; (4) \u2018international organisation of European interest\u2019 means an international organisation, the majority of whose members are Member States or whose headquarters are in a Member State; (5) \u2018European Digital Innovation Hub\u2019 means a legal entity selected in accordance with Article 16 in order to fulfil the tasks under the Programme, in particular by directly providing, or ensuring access to, technological expertise and experimentation facilities, such as equipment and software tools to enable the digital transformation of industry, as well as by facilitating access to finance and it is open to businesses of all forms and sizes, in particular to SMEs, mid-caps and scale-up companies, and to public administrations across the Union; (6) \u2018advanced digital skills\u2019 means the skills and professional competencies requiring the knowledge and experience necessary to understand, design, develop, manage, test, deploy, use and maintain the technologies, products and services supported by the Programme as referred to in Article 7; (7) \u2018European Partnership\u2019 means a European Partnership as defined in point (3) of Article 2 of Regulation (EU) 2021/695; (8) \u2018small or medium-sized enterprise\u2019 or \u2018SME\u2019 means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC (24); (9) \u2018cybersecurity\u2019 means the activities necessary to protect network and information systems, the users of such systems, and other persons affected by cyber threats; (10) \u2018digital service infrastructures\u2019 means infrastructures which enable networked services to be delivered electronically, typically over the internet; (11) \u2018Seal of Excellence\u2019 means a quality label which shows that a proposal submitted to a call for proposals under the Programme has passed all of the evaluation thresholds set out in the work programme, but could not be funded due to a lack of budget available for that call for proposals in the work programme, and might receive support from other Union or national sources of funding; (12) \u2018exascale\u2019 means, in the context of computing systems, being capable of executing 1018 (ten to the power of 18) floating operations per second. Article 3 Programme objectives 1. The general objectives of the Programme shall be to support and accelerate the digital transformation of the European economy, industry and society, to bring its benefits to citizens, public administrations and businesses across the Union, and to improve the competitiveness of Europe in the global digital economy while contributing to bridging the digital divide across the Union and reinforcing the Union\u2019s strategic autonomy, through holistic, cross-sectoral and cross-border support and a stronger Union contribution. The Programme shall be implemented in close coordination with other Union programmes as applicable, and shall aim: (a) to strengthen and promote Europe\u2019s capacities in key digital technology areas through large-scale deployment; (b) in the private sector and in areas of public interest, to widen the diffusion and uptake of Europe\u2019s key digital technologies, promoting the digital transformation and access to digital technologies. 2. The Programme shall have five interrelated specific objectives: (a) Specific Objective 1 \u2013 High Performance Computing (b) Specific Objective 2 \u2013 Artificial Intelligence (c) Specific Objective 3 \u2013 Cybersecurity and Trust (d) Specific Objective 4 \u2013 Advanced Digital Skills (e) Specific Objective 5 Deployment and Best Use of Digital Capacity and Interoperability. Article 4 Specific Objective 1- High Performance Computing 1. The financial contribution from the Union under Specific Objective 1 \u2013 High Performance Computing shall pursue the following operational objectives: (a) deploy, coordinate at Union level and operate an integrated demand-oriented and application-driven world-class exascale supercomputing and data infrastructure that shall be easily accessible to public and private users, in particular SMEs, irrespective of the Member State in which they are located, and easily accessible for research purposes, in accordance with Regulation (EU) 2018/1488; (b) deploy ready to use operational technology resulting from research and innovation in order to build an integrated Union HPC ecosystem, covering various aspects in the scientific and industrial value chain segments, including hardware, software, applications, services, interconnections and digital skills, with a high level of security and data protection; (c) deploy and operate post-exascale infrastructure, including integration with quantum computing technologies and research infrastructures for computing science and encourage the development within the Union of the hardware and software necessary for such deployment. 2. The actions under Specific Objective 1 shall be primarily implemented through the European High Performance Computing Joint Undertaking established by Regulation (EU) 2018/1488. Article 5 Specific Objective 2 \u2013 Artificial Intelligence 1. The financial contribution from the Union under Specific Objective 2 \u2013 Artificial Intelligence shall pursue the following operational objectives: (a) build up and strengthen core AI capacities and knowledge in the Union, including building up and strengthening quality data resources and corresponding exchange mechanisms, and libraries of algorithms, while guaranteeing a human-centric and inclusive approach that respects Union values; (b) make the capacities referred to in point (a) accessible to businesses, especially SMEs and start-ups, as well as civil society, not-for-profit organisations, research institutions, universities and public administrations, in order to maximise their benefit to the European society and economy; (c) reinforce and network AI testing and experimentation facilities in Member States; (d) develop and reinforce commercial application and production systems in order to facilitate the integration of technologies in value chains and the development of innovative business models and to shorten the time required to pass from innovation to commercial exploitation and foster the uptake of AI-based solutions in areas of public interest and in society. AI-based solutions and data made available shall respect the principle of privacy and security by design and shall fully comply with data protection legislation. 2. The Commission, in accordance with Union and international law, including the Charter, and taking into account, inter alia, the recommendations of the High-Level Expert Group on Artificial Intelligence, shall set out ethical requirements in the work programmes under Specific Objective 2. Calls for proposals, calls for tenders and grant agreements shall include the relevant requirements set out in those work programmes. Where appropriate, the Commission shall carry out checks to ensure compliance with those ethical requirements. Funding for actions which do not comply with the ethical requirements may be suspended, terminated or reduced at any time in accordance with the Financial Regulation. 3. The actions under Specific Objective 2 shall be implemented primarily through direct management. The ethical and legal requirements referred to in this Article shall apply to all actions of Specific Objective 2, regardless of the method of implementation. Article 6 Specific Objective 3 \u2013 Cybersecurity and Trust 1. The financial contribution from the Union under Specific Objective 3 \u2013 Cybersecurity and Trust shall pursue the following operational objectives: (a) support the building-up and procurement of advanced cybersecurity equipment, tools and data infrastructures, together with Member States, in order to achieve a high common level of cybersecurity at European level, in full compliance with data protection legislation and fundamental rights, while ensuring the strategic autonomy of the Union; (b) support the building-up and best use of European knowledge, capacity and skills related to cybersecurity and the sharing and mainstreaming of best practices; (c) ensure a wide deployment of effective state-of-the-art cybersecurity solutions across the European economy, paying special attention to public authorities and SMEs; (d) reinforce capabilities within Member States and private sector to help them comply with Directive (EU) 2016/1148 of the European Parliament and of the Council (25) including through measures supporting the uptake of cybersecurity best practices; (e) improve resilience against cyberattacks, contribute towards increasing risk-awareness and knowledge of cybersecurity processes, support public and private organisations in achieving basics levels of cybersecurity, for example by deploying end-to-end encryption of data and software updates; (f) enhance cooperation between the civil and defence spheres with regard to dual-use projects, services, competences and applications in cybersecurity, in accordance with a Regulation establishing the European Cybersecurity Industrial, Technology and Research Competence Centre and the Network of National Coordination Centres (the \u2018Cybersecurity Competence Centre Regulation\u2019). 2. The actions under Specific Objective 3 shall be implemented primarily through the European Cybersecurity Industrial, Technology and Research Competence Centre and the Network of National Coordination Centres in accordance with the Cybersecurity Competence Centre Regulation. Article 7 Specific Objective 4 \u2013 Advanced Digital Skills 1. The financial contribution from the Union under Specific Objective 4 \u2013 Advanced Digital Skills shall support the development of advanced digital skills in areas covered by the Programme in order to contribute to increasing Europe\u2019s talent pool, bridge the digital divide and foster greater professionalism, especially with regard to high performance and cloud computing, big data analytics, cybersecurity, distributed ledger technologies (e.g. blockchain), quantum technologies, robotics, AI, while taking gender balance into account. In order to tackle skills mismatches and to encourage specialisation in digital technologies and applications, the financial contribution shall pursue the following operational objectives: (a) support the design and delivery of high-quality, long-term training and courses, including blended learning, for students and for the workforce; (b) support the design and delivery of high-quality, short-term training and courses for the workforce, in particular in SMEs and in the public sector; (c) support high-quality on-the-job training and work placements for students, including traineeships, and the workforce, in particular in SMEs and in the public sector. 2. The actions under Specific Objective 4 shall be implemented primarily through direct management. Article 8 Specific Objective 5 \u2013 Deployment and Best Use of Digital Capacities and Interoperability 1. The financial contribution from the Union under Specific Objective 5 \u2013 Deployment and Best Use of Digital Capacities and Interoperability shall pursue the following operational objectives while bridging the digital divide: (a) support the public sector and areas of public interest, such as health and care, education, judiciary, customs, transport, mobility, energy, environment, cultural and creative sectors, including relevant businesses established within the Union, to effectively deploy and access state-of-the-art digital technologies, such as HPC, AI and cybersecurity; (b) deploy, operate and maintain trans-European interoperable state-of-the-art digital service infrastructures across the Union, including related services, in complementarity with national and regional actions; (c) support the integration and use of trans-European digital service infrastructures and of agreed European digital standards in the public sector and in areas of public interest to facilitate cost-efficient implementation and interoperability; (d) facilitate the development, update and use of solutions and frameworks by public administrations, businesses and citizens, including of open-source solutions and the re-use of interoperability solutions and frameworks; (e) offer the public sector and the Union industry, in particular SMEs, easy access to testing and piloting of digital technologies and increase the use thereof, including their cross-border use; (f) support the uptake by the public sector and the Union industry, in particular SMEs and start-ups, of advanced digital and related technologies, including in particular HPC, AI, cybersecurity, other leading edge and future technologies, such as distributed ledger technologies (e.g. blockchain); (g) support the design, testing, implementation, and deployment and maintenance of interoperable digital solutions, including digital government solutions, for public services at Union level which are delivered through a data-driven reusable solutions platform aiming to foster innovation and establish common frameworks in order to unleash the full potential of the public administrations\u2019 services for citizens and businesses; (h) ensure the continuous capacity at Union level to lead digital development, in addition to observing, analysing and adapting to fast-evolving digital trends, and share and mainstream best practices; (i) support cooperation towards achieving a European ecosystem for trusted data sharing and digital infrastructures using, inter alia, services and applications based on distributed ledger technologies (e.g. blockchain), including support for interoperability and standardisation and by fostering the deployment of Union cross-border applications based on security and privacy by design, while complying with consumer and data protection legislation; (j) build up and strengthen the European Digital Innovation Hubs and their network. 2. The actions under Specific Objective 5 shall be implemented primarily through direct management. Article 9 Budget 1. The financial envelope for the implementation of the Programme for the period from 1 January 2021 to 31 December 2027 shall be EUR 7 588 000 000 in current prices. 2. The indicative distribution of the amount referred to in paragraph 1 shall be: (a) EUR 2 226 914 000 for Specific Objective 1 \u2013 High Performance Computing; (b) EUR 2 061 956 000 for Specific Objective 2 \u2013 Artificial Intelligence; (c) EUR 1 649 566 000 for Specific Objective 3 \u2013 Cybersecurity and Trust; (d) EUR 577 347 000 for Specific Objective 4 \u2013 Advanced Digital Skills; (e) EUR 1 072 217 000 for Specific Objective 5 \u2013 Deployment and Best Use of Digital Capacities and Interoperability. 3. The amount referred to in paragraph 1 may also be used for technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities, including by using corporate information technology systems. 4. Budgetary commitments for actions extending over more than one financial year may be broken down over several years into annual instalments. 5. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme, subject to the conditions set out in the relevant provision of the Common Provisions Regulation for 2021-2027, including for the purpose of complementing grants awarded to an action, up to 100 % of the total eligible cost where possible, without prejudice to the co-financing principle laid down in Article 190 of the Financial Regulation and to the State aid rules. The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. 6. Where the Commission has not entered into a legal commitment under direct or indirect management for resources transferred in accordance with paragraph 5 of this Article, the corresponding uncommitted resources may be transferred back to one or more respective source programmes, at the request of the Member State concerned, in accordance with the conditions set out in the relevant provision of the Common Provisions Regulation for 2021-2027. 7. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, in duly justified cases specified in the financing decision and for a limited period, actions supported under this Regulation and the underlying costs may be considered to be eligible as of 1 January 2021, even if they were implemented and incurred before the grant application was submitted. Article 10 Third countries associated to the Programme 1. The Programme shall be open to the participation of the following third countries through association or partial association, in accordance with the objectives laid down in Article 3: (a) members of the European Free Trade Association, which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes and their administrative costs; (iii) does not confer on the third country any decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests; The contributions referred to in point (d)(ii) of the first subparagraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. 2. Association or partial association of third countries to the Programme shall be without prejudice to Article 12(5). Article 11 International cooperation 1. The Union may cooperate with third countries as referred to in Article 10, with other third countries and with international organisations or bodies established in those countries, in particular within the framework of the Euro-Mediterranean and Eastern Partnerships and with neighbouring countries, especially those of the Western Balkans and Black Sea regions. Without prejudice to Article 18, related costs incurred shall not be covered by the Programme. 2. Cooperation with third countries and organisations as referred to in paragraph 1 of this Article with respect to Specific Objectives 1, 2 and 3 shall be subject to Article 12. Article 12 Security 1. Actions carried out under the Programme shall comply with applicable security rules, including with Union and national law and in particular in relation to the protection of the classified information against unauthorised disclosure. In the case of actions carried out outside the Union using or generating classified information, in addition to compliance with above requirements such actions shall be subject to a security agreement concluded between the Union and the third country in which the activity is conducted. 2. Where appropriate, proposals and tenders to be submitted by applicants shall include a security self-assessment that identifies any security issues and details how those issues are to be addressed in order to comply with Union and national law. 3. Where appropriate, the Commission or the body entrusted with the implementation of the Programme shall carry out a security review of proposals for funding submitted by applicants that raise security issues. 4. Where appropriate, the actions carried out under the Programme shall comply with Commission Decision (EU, Euratom) 2015/444 (26) and the rules implementing that Decision. 5. The work programme may also provide that legal entities established in associated countries and legal entities that are established in the Union but are controlled from third countries are not eligible to participate in all or some actions under Specific Objective 3 for duly justified security reasons. In such cases, calls for proposals and calls for tenders shall be restricted to legal entities established or deemed to be established in Member States and controlled by Member States or by nationals of Member States. 6. If duly justified for security reasons, the work programme may also provide that legal entities established in associated countries and legal entities that are established in the Union but are controlled from third countries may be eligible to participate in all or some actions under Specific Objectives 1 and 2 only if they comply with the requirements to be fulfilled by those legal entities to guarantee the protection of the essential security interests of the Union and the Member States and to ensure the protection of classified documents information. Those requirements shall be set out in the work programme. 7. Where appropriate, the Commission or the body entrusted with the implementation of the Programme shall carry out security checks. Funding for actions which do not comply with the security requirements referred to in this Article may be suspended, terminated or reduced at any time, in accordance with the Financial Regulation. Article 13 Synergies with other Union programmes 1. The Programme shall enable synergies with other Union programmes, as described in Annex III, in particular through arrangements for complementary funding from Union programmes where the management arrangements allow it. Funding from other programmes may be deployed in sequence, in an alternating way, or through the combination of funds, including the joint funding of actions. The Commission shall ensure that the achievement of the specific objectives is not hampered when leveraging the complementary character of the Programme with other Union programmes. 2. The Commission shall ensure the overall consistency and complementarity of the Programme with the relevant policies and Union programmes in cooperation with the Member States. To that end, the Commission shall facilitate the setting up of appropriate mechanisms for coordination between relevant authorities and between such authorities and the Commission, and shall establish appropriate monitoring tools to systematically ensure synergies between the Programme and any relevant Union funding instruments. The arrangements referred to in paragraph 1 shall contribute to avoiding duplications and to maximising the positive impact of expenditure. Article 14 Implementation and forms of Union funding 1. The Programme shall be implemented under direct management, in accordance with the Financial Regulation, or under indirect management by entrusting certain implementation tasks to the bodies referred to in point (c) of the first subparagraph of Article 62(1) of the Financial Regulation, in accordance with Articles 4 to 8 of this Regulation. Bodies entrusted with the implementation of the Programme may depart from the rules on participation and dissemination laid down in this Regulation only where such departure is provided for in the legal act that establishes those bodies or entrusts budget implementation tasks to them or, for the bodies referred to in point (c)(ii), (iii) or (v) of the first subparagraph of Article 62(1) of the Financial Regulation, where such departure is provided for in the contribution agreement and the specific operating needs of such bodies or the nature of the action so require. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, including in particular through procurement as a primary form, or grants and prizes. Where the achievement of the objective of an action requires the procurement of innovative goods and services, grants may be awarded only to beneficiaries that are contracting authorities or contracting entities as defined in Directives 2014/24/EU (27) and 2014/25/EU (28) of the European Parliament and of the Council. Where the supply of innovative goods or services that are not yet available on a large-scale commercial basis is necessary to achieve the objectives of an action, the contracting authority or the contracting entity may authorise the award of multiple contracts within the same procurement procedure. For duly justified reasons of public security, the contracting authority or the contracting entity may require that the place of performance of the contract be situated within the territory of the Union. The Programme may also provide financing in the form of financial instruments within blending operations. 3. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and shall be considered to be a sufficient guarantee under the Financial Regulation. Article 37 of Regulation (EU) 2021/695 shall apply. Article 15 European Partnerships The Programme may be implemented through European Partnerships and within the strategic planning between the Commission and the Member States, as referred to in Article 6 of Regulation (EU) 2021/695. Such implementation may include contributions to existing or new public-private partnerships in the form of joint undertakings established under Article 187 TFEU. For those contributions, the provisions of that Regulation relating to European Partnerships shall apply. Article 16 European Digital Innovation Hubs 1. An initial network of European Digital Innovation Hubs shall be established during the first year of the implementation of the Programme. That initial network shall consist of at least one hub for each Member State, unless there is no candidate in a given Member State that can be designated and selected in accordance with paragraphs 2 and 3. 2. For the purpose of establishing the network referred to in paragraph 1 of this Article, each Member State shall designate candidate entities in accordance with its national procedures, administrative and institutional structures through an open and competitive process, on the basis of the following criteria: (a) the appropriate competences related to the activities of the European Digital Innovation Hubs referred to in paragraph 6 of this Article and competences in one or several areas identified in Article 3(2); (b) the appropriate management capacity, staff and infrastructure necessary to carry out the activities referred to in paragraph 6 of this Article; (c) the operational and legal means to apply the administrative, contractual and financial management rules laid down at Union level; and (d) the appropriate financial viability corresponding to the level of Union funds it will be called upon to manage and demonstrated, where appropriate, through guarantees issued preferably by a public authority. 3. The Commission shall, by means of implementing acts, adopt decisions on the selection of entities forming the initial network. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). The Commission shall take the utmost account of the opinion of each Member State before selecting a European Digital Innovation Hub in its territory. The entities shall be selected by the Commission from candidate entities designated by Member States on the basis of the criteria referred to in paragraph 2 of this Article and the following additional criteria: (a) the budget available for the financing of the initial network; and (b) the need for the initial network to ensure coverage of the needs of industry and areas of public interest and to ensure comprehensive and balanced geographical coverage to improve convergence between Member States benefiting from the Cohesion Fund for 2021 to 2027 established by a Regulation of the European Parliament and of the Council and the other Member States, for example to bridge the digital divide in geographical terms. 4. If necessary, following an open and competitive process, the Commission shall, by means of implementing acts, adopt decisions on the selection of entities forming additional European Digital Innovation Hubs. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). The Commission shall take the utmost account of the opinion of the Member State before selecting an additional European Digital Innovation Hub in its territory. The Commission shall select additional European Innovation Hubs in such a way to ensure a broad geographical coverage across Europe. The number of entities of the network shall be sufficient to meet the demand for the hubs\u2019 services in given Member States. To address the specific constraints faced by the Union\u2019s outermost regions, specific entities may be nominated to cover the needs of such regions. 5. European Digital Innovation Hubs shall have substantial overall autonomy to lay down their organisation, composition, and working methods. 6. With respect to the implementation of the Programme, European Digital Innovation Hubs shall perform the following activities to the benefit of the Union industry, in particular SMEs and mid-caps, as well as the public sector: (a) raising awareness and providing or ensuring access to digital transformation expertise, knowhow and services, including testing and experimentation facilities; (b) assisting businesses, especially SMEs and start-ups, organisations and public administrations to become more competitive and to improve their business models through use of new technologies covered by the Programme; (c) facilitating the transfer of expertise and knowhow between regions, in particular by matching SMEs, start-ups and mid-caps established in one region with European Digital Innovation Hubs established in other regions that are best suited to providing relevant services; encouraging exchanges of skills and knowledge, joint initiatives and good practices; (d) providing or ensuring access to thematic services, in particular services related to AI, HPC and cybersecurity and trust to the public administrations, public sector organisations, SMEs or mid-caps; (e) providing financial support to third parties under Specific Objective 4. For the purposes of point (d) of the first subparagraph, European Digital Innovation Hubs may specialise in specific thematic services and shall not be required to provide all thematic services or to provide those services to all categories of entities referred to in this paragraph. 7. Where a European Digital Innovation Hub receives funding under the Programme, that funding shall be in the form of grants. CHAPTER II ELIGIBILITY Article 17 Eligible actions 1. Only actions contributing to the achievement of the objectives laid down in Articles 3 to 8 shall be eligible for funding. 2. The eligibility criteria for actions to be carried out under the Programme shall be set out in the work programmes. Article 18 Eligible legal entities 1. The following legal entities shall be eligible to participate in the Programme: (a) legal entities established in: (i) a Member State or an overseas country or territory linked to a Member State; (ii) a third country associated to the Programme in accordance with Articles 10 and 12; (b) any other legal entity created under Union law and any international organisation of European interest. 2. By way of derogation from paragraph 1, legal entities established in a third country which is not associated to the Programme shall be eligible to participate in specific actions where their participation is necessary to achieve the objectives of the Programme. Such entities shall bear the cost of their participation unless specified otherwise in the work programmes. 3. Natural persons shall not be eligible to participate in the Programme, except for grants awarded under Specific Objective 4. 4. The work programme referred to in Article 24 may provide that participation is limited to beneficiaries established only in Member States, or to beneficiaries established in Member States and specific associated countries or other third countries, where there are security reasons for such limitation or where the actions directly relate to the Union\u2019s strategic autonomy. Any limitation of the participation of legal entities established in associated countries shall comply with the terms and conditions of the relevant agreement. CHAPTER III GRANTS Article 19 Grants Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation and may cover up to 100 % of the eligible costs, without prejudice to the co-financing principle as laid down in Article 190 of the Financial Regulation. Such grants shall be awarded and managed as specified for each specific objective. Article 20 Award criteria 1. The award criteria shall be set out in the work programmes and in the calls for proposals, taking into account at least the following elements: (a) the maturity of the action in the project development; (b) the soundness of the implementation plan proposed; (c) the need to overcome financial obstacles such as a lack of market finance. 2. Where applicable, the award criteria, shall take into account the following elements: (a) the stimulating effect of Union support on public and private investment; (b) the expected economic, social, climate and environmental impact; (c) accessibility and ease of access to respective services; (d) a trans-European dimension; (e) a balanced geographical distribution across the Union, including bridging the geographical digital divide, including the outermost regions; (f) the presence of a long-term sustainability plan; (g) the freedom to re-use and adapt the projects\u2019 results; (h) synergies and complementarities with other Union programmes. Article 21 Evaluation In accordance with Article 150 of the Financial Regulation, applications for grants shall be evaluated by an evaluation committee, which may be fully or partially composed of external independent experts. CHAPTER IV BLENDING OPERATIONS AND OTHER COMBINED FUNDING Article 22 Blending operations Blending operations under the Programme shall be carried out in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. Article 23 Cumulative and alternative funding 1. An action that has received a contribution from another Union programme, including funds under shared management, may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action.The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 2. In order to be awarded a Seal of Excellence under the Programme, actions shall comply with all of the following conditions: (a) they have been assessed in a call for proposals under the Programme; (b) they comply with the minimum quality requirements of that call for proposals; (c) they are not financed under that call for proposals due to budgetary constraints. In accordance with the relevant provisions of the Common Provisions Regulation for 2021-2027, the ERDF or ESF+ may support proposals submitted to a call for proposals under the Programme, which were awarded a Seal of Excellence in accordance with the Programme. CHAPTER V PROGRAMMING, MONITORING, EVALUATION AND CONTROL Article 24 Work programmes 1. The Programme shall be implemented by means of work programmes as referred to in Article 110 of the Financial Regulation. 2. Work programmes shall in principle be adopted as multiannual programmes, typically every two years, and cover the general objectives of the Programme as well as one or more specific objectives. If justified by specific implementation needs, they may also be adopted as annual programmes. 3. Work programmes shall be consistent with the specific objectives of the Programme, as set out in Articles 4 to 8, while also taking into account the areas and types of activities set out in Annex I. They shall ensure that the actions thereby supported do not crowd out private financing. 4. In order to reflect technological change and market developments, the Commission is empowered to adopt delegated acts in accordance with Article 30 to amend Annex I with regard to the activities set out therein in a manner consistent with the specific objectives of the Programme, as set out in Articles 4 to 8. 5. Work programmes shall set out, where applicable, the overall amount reserved for blending operations. 6. The Commission shall, by means of implementing acts, adopt the work programmes for Specific Objectives 2, 4 and 5 and for possible other actions under direct management for Specific Objectives 1 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). Article 25 Monitoring and reporting 1. Measurable indicators to monitor the implementation and to report on the progress of the Programme towards the achievement of the specific objectives laid down in Article 3(2) are set out in Annex II. 2. The Commission shall establish a methodology to provide for indicators for accurately assessing progress made towards the achievement of the general objectives laid down in Article 3(1). 3. In order to ensure the effective assessment of the Programme\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts in accordance with Article 30 to amend Annex II with regard to the measurable indicators, where considered to be necessary, as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 4. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively, and in a timely manner so that the results are suitable for an in-depth analysis of the progress achieved and the difficulties encountered. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where necessary, on Member States. 5. Official EU statistics, such as regular ICT statistical surveys, shall be used to their maximum as context indicators. The Commission shall consult national statistical institutes and shall involve them, together with Eurostat, in the initial design and subsequent development of statistical indicators used for monitoring the implementation of the Programme and progress made with regard to digital transformation. Article 26 Evaluation of the Programme 1. Evaluations of the Programme shall be carried out so that they feed into the decision-making process in a timely manner. They shall contain a qualitative assessment of the progress made towards the achievement of the general objectives of the Programme laid down in Article 3. 2. In addition to regularly monitoring the Programme, the Commission shall conduct an interim evaluation of the Programme which shall be carried out once there is sufficient information available about its implementation, but no later than four years after the start of the implementation of the Programme. The interim evaluation shall form the basis for adjusting the implementation of the Programme, as appropriate, also taking into account new relevant technological developments. 3. At the end of the implementation of the Programme, but no later than four years after the end of the period specified in Article 1, the Commission shall carry out a final evaluation of the Programme. The final evaluation shall assess long-term impacts of the Programme and its sustainability. 4. The evaluation reporting system shall ensure that recipients of Union funds collect data for programme evaluation in an efficient, effective and timely manner and at the appropriate level of granularity. 5. The Commission shall submit the interim evaluation referred to in paragraph 2 and the final evaluation referred to in paragraph 3 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 27 Audits 1. Audits on the use of the Union contribution carried out by persons or entities, including by others than those mandated by the Union institutions, bodies, offices or agencies shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. 2. The control system shall ensure an appropriate balance between trust and control, taking into account administrative costs and other costs related to control at all levels. 3. Audits of expenditure shall be carried out in a consistent manner in accordance with the principles of economy, efficiency and effectiveness. 4. As part of the control system, the audit strategy may be based on the financial audit of a representative sample of expenditure. That representative sample shall be complemented by a selection based on an assessment of the risks related to expenditure. 5. Actions that receive cumulative funding from different Union programmes shall be audited only once, covering all programmes concerned and their respective applicable rules. Article 28 Protection of the financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 29 Information, communication, publicity, policy support and dissemination 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the Programme, to actions taken pursuant to the Programme and to the results obtained. The Commission shall also ensure that integrated information is provided and that it reaches potential applicants to Union funding in the digital sector. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. 3. The Programme shall provide support to policy development, outreach, awareness-raising and the dissemination of actions related to the Programme and shall promote cooperation and the exchange of experience in the areas referred to in Articles 4 to 8. CHAPTER VI DELEGATED ACTS, IMPLEMENTING ACTS, TRANSITIONAL AND FINAL PROVISIONS Article 30 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 24(4) and Article 25(3) shall be conferred on the Commission until 31 December 2028. 3. The delegation of power referred to in Article 24(4) and Article 25(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 24(4) and Article 25(3) shall only enter into force if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 31 Committee procedure 1. The Commission shall be assisted by the Digital Europe Programme Coordination Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 32 Repeal Decision (EU) 2015/2240 is repealed with effect from 1 January 2021. Article 33 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions inititated pursuant to Regulation (EU) No 283/2014 of the European Parliament and of the Council (29) and Decision (EU) 2015/2240, which shall continue to apply to those actions until their closure. 2. The financial envelope for the Programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted pursuant to Regulation (EU) No 283/2014 and Decision (EU) 2015/2240. 3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 9(4), to enable the management of actions not completed by 31 December 2027. Article 34 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 April 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 62, 15.2.2019, p. 292. (2) OJ C 86, 7.3.2019, p. 272. (3) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and position of the Council at first reading of 16 March 2021 (OJ C 124, 9.4.2021, p. 1). Position of the European Parliament of 29 April 2021 (not yet published in the Official Journal). (4) OJ L 433I, 22.12.2020, p. 28. (5) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, p. 11). (6) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (7) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (8) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (9) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (10) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (11) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (12) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (\u2018Overseas Association Decision\u2019) (OJ L 344, 19.12.2013, p. 1). (13) OJ L 123, 12.5.2016, p. 1. (14) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (15) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36). (16) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (17) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (18) Council Regulation (EU) 2018/1488 of 28 September 2018 establishing the European High Performance Computing Joint Undertaking (OJ L 252, 8.10.2018, p. 1). (19) Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15). (20) OJ L 1, 3.1.1994, p. 3. (21) OJ L 282, 19.10.2016, p. 4. (22) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (23) Decision (EU) 2015/2240 of the European Parliament and of the Council of 25 November 2015 establishing a programme on interoperability solutions and common frameworks for European public administrations, businesses and citizens (ISA2 programme) as a means for modernising the public sector (OJ L 318, 4.12.2015, p. 1). (24) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (25) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). (26) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (27) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (28) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (29) Regulation (EU) No 283/2014 of the European Parliament and of the Council of 11 March 2014 on guidelines for trans-European networks in the area of telecommunications infrastructure and repealing Decision No 1336/97/EC (OJ L 86, 21.3.2014, p. 14). ANNEX I ACTIONS Technical description of the Programme: scope of actions The initial and, where appropriate, subsequent actions of the Programme shall be implemented in accordance with the following technical description: Specific Objective 1 \u2013 High Performance Computing The Programme shall implement the European strategy on HPC by supporting a full Union ecosystem that provides the necessary HPC and data capabilities for Europe to compete globally. The strategy aims to deploy a world-class HPC and data infrastructure with exascale capabilities between 2022 and 2023, and with post-exascale facilities between 2026 and 2027 to endow the Union with its own independent and competitive HPC technology supply, achieve excellence in HPC applications and widen the availability and use of HPC. Initial and, where appropriate, subsequent actions under this objective shall include: 1. A joint procurement framework enabling a co-designed approach for the acquisition of an integrated network of world-class HPC, including the acquisition of exascale supercomputing and data infrastructure. That network will be easily accessible to public and private users, in particular SMEs, irrespective of the Member State in which they are located, and will be easily accessible for research purposes, in accordance with Regulation (EU) 2018/1488. 2. A joint procurement framework for the acquisition of post-exascale supercomputing infrastructure, including the integration with quantum computing technologies. 3. Coordination and adequate financial resources at Union level to support the development, procurement and operation of such infrastructure. 4. Networking of Member States HPC and data capacities and support for Member States wishing to upgrade or acquire new HPC capacities. 5. Networking of national High Performance Computing competence centres, at least one per Member State and associated with their national supercomputing centres to provide HPC services to industry, in particular SMEs, the academic community and public administrations. 6. The deployment of ready to use operational technology, in particular supercomputing as a service resulting from research and innovation to build an integrated European HPC ecosystem, covering all segments of the scientific and industrial value chain (hardware, software, applications, services, interconnections and advanced digital skills). Specific Objective 2 \u2013 Artificial Intelligence The Programme shall build up and strengthen core AI capacities in Europe, including data resources and repositories of algorithms, and make them accessible to all public administrations and businesses, and shall reinforce and network existing and newly established AI testing and experimentation facilities in Member States. Initial and, where appropriate, subsequent actions under this objective shall include: 1. The creation of common European data spaces that make accessible data across Europe, including information gathered from the re-use of public sector information, and become a data input source for AI solutions. The spaces should be open to the public and private sectors. For increased usage, data within a space are to be made interoperable, in particular through data formats that are open, machine readable, standardised and documented, both in the interactions between the public and private sectors, within sectors and across sectors (semantic interoperability). 2. The development of common European libraries or interfaces to libraries of algorithms that make them easily accessible to all potential European users on the basis of fair, reasonable and non-discriminatory terms. Businesses and the public sector are to be able to identify and acquire whichever solution would work best for their needs. 3. Co-investment with Member States in world class reference facilities for testing and experimentation in real setting focusing on the applications of AI in essential sectors such as health, earth or environment monitoring, transport and mobility, security, manufacturing and finance, as well as in other areas of public interest. Those facilities are to be open to all actors across Europe and connected to the network of European Digital Innovation Hubs. Those facilities are to be equipped with or connected to large computing and data handling facilities, as well as latest AI technologies, including emerging areas such as neuromorphic computing, deep learning and robotics. Specific Objective 3 \u2013 Cybersecurity and Trust The Programme shall stimulate the reinforcement, building and acquisition of essential capacities to secure the Union\u2019s digital economy, society and democracy by reinforcing the Union cybersecurity industrial potential and competitiveness, as well as by improving capabilities of both the private and public sectors to protect citizens and businesses from cyber threats, including by supporting the implementation of Directive (EU) 2016/1148. Initial and, where appropriate, subsequent actions under this objective shall include: 1. Co-investment with Member States in advanced cybersecurity equipment, infrastructures and knowhow that are essential to protect critical infrastructures and the Digital Single Market at large. Such co-investment could include investments in quantum facilities and data resources for cybersecurity, situational awareness in cyberspace as well as other tools to be made available to public and private sector across Europe. 2. Scaling up existing technological capacities and networking the competence centres in Member States and making sure that those capacities respond to public sector and industry needs, including through products and services that reinforce cybersecurity and trust within the Digital Single Market. 3. Ensuring wide deployment of effective state-of-the-art cybersecurity and trust solutions across the Member States. Such deployment includes strengthening the security and safety of products, from their design to their commercialisation. 4. Support closing the cybersecurity skills gap by, for example, aligning cybersecurity skills programmes, adapting them to specific sectorial needs and facilitating access to targeted specialised training. Specific Objective 4 \u2013 Advanced digital skills The Programme shall support access to advanced digital skills and training opportunities on those skills, in particular in HPC, big data analytics, AI, distributed ledger technologies (e.g. blockchain) and cybersecurity for the current and future workforce by offering, inter alia, students, recent graduates, current workers and citizens of all ages in need of upskilling, wherever they are situated, with the means to acquire and develop those skills. Initial and, where appropriate, subsequent actions under this objective shall include: 1. Access to on-the-job training by taking part in traineeships in competence centres and businesses that deploy advanced digital technologies. 2. Access to courses in advanced digital technologies which are to be offered by higher education institutions, research institutions and industry professional certification bodies in cooperation with the bodies involved in the Programme (topics are expected to include AI, cybersecurity, distributed ledger technologies (e.g. blockchain), HPC and quantum technologies). 3. Participation in short-term, specialised professional training that have been pre-certified, for example in the area of cybersecurity. Interventions shall focus on advanced digital skills related to specific technologies. The European Digital Innovation Hubs provided for in Article 16 shall act as facilitators for training opportunities, liaising with education and training providers. Specific Objective 5 \u2013 Deployment and Best Use of Digital Capacities and Interoperability Projects serving the deployment and the best use of digital capacities or interoperability shall constitute projects of common interest. I. Initial and, where appropriate, subsequent actions under this objective related to the digital transformation of areas of public interest shall include: 1. Modernisation of public administrations: 1.1. Support Member States in the implementation of the principles of the Tallinn Declaration on eGovernment in all policy domains, creating, where necessary, the necessary registries and interconnecting them in full compliance with Regulation (EU) 2016/679. 1.2. Support the design, piloting, deployment, maintenance, evolution and promotion of a coherent eco-system of cross-border digital services infrastructure and facilitate seamless end-to-end, secure, interoperable, multi-lingual cross-border or cross-sector solutions and common frameworks within public administrations. Methodologies for assessing the impact and benefits shall also be included. 1.3. Support the assessment, updating and promotion of existing common specifications and standards as well as the development, establishment and promotion of new common specifications, open specifications and standards through the Union\u2019s standardisation platforms and in cooperation with European or international standardisation organisations as appropriate. 1.4. Cooperate towards a European ecosystem for trusted infrastructures, possibly using services and applications based on distributed ledger technologies (e.g. blockchain), including support for interoperability and standardisation and fostering the deployment of Union cross-border applications. 2. Health 2.1. Ensure that citizens have control over their personal data and can access, share, use, and manage their personal health data across borders securely and in a way that guarantees their privacy, irrespective of their location or the location of the data, in accordance with applicable data protection legislation. Complete the eHealth digital service infrastructure and extend it by new digital services in relation to disease prevention, health and care and support the deployment of such services, building on a broad support by Union activities and Member States, in particular in the eHealth network according to Article 14 of Directive 2011/24/EU of the European Parliament and of the Council (1). 2.2. Make available better data for research, disease prevention and personalised health and care. Ensure that European health researchers and clinical practitioners have access to the necessary scale of resources (shared data spaces, including data storage and computing, expertise and analytical capacities) to achieve breakthroughs in major as well as in rare diseases. The target is to ensure a population-based cohort of at least 10 million citizens. 2.3. Make digital tools available for citizen empowerment and for person-centred care by supporting the exchange of innovative and best practices in digital health, capacity building and technical assistance, in particular for cybersecurity, AI and HPC. 3. Judiciary Enable seamless and secure cross-border electronic communication within the judiciary and between the judiciary and other competent bodies in the area of civil and criminal justice. Improve access to justice and to legal information and procedures for citizens, businesses, legal practitioners and members of the judiciary by providing semantically interoperable interconnections to databases and registers as well as by facilitating online out-of-court dispute resolution. Promote the development and implementation of innovative technologies for courts and the legal profession based, inter alia, on AI solutions which are likely to streamline and speed-up procedures (for example, \u2018legal tech\u2019 applications). 4. Transport, mobility, energy and environment Deploy decentralised solutions and infrastructures required for large-scale digital applications such as connected automated driving, unmanned aerial vehicles, smart mobility concepts, smart cities, smart rural areas or outermost regions, in support of transport, energy and environmental policies and in coordination with the actions for digitalising the transport and energy sectors under Connecting Europe Facility. 5. Education, culture and media Provide creators, creative industry and cultural sectors in Europe with access to the latest digital technologies from AI to advanced computing. Exploit the European cultural heritage, including Europeana, to support education and research and to promote cultural diversity, social cohesion and European society. Support the uptake of digital technologies in education, as well as private and publicly funded cultural institutions. 6. Other actions supporting the Digital Single Market Support actions such as fostering digital and media literacy and raising awareness among minors, parents and teachers regarding risks minors may encounter online and ways to protect them, tackling cyberbullying and the dissemination of child sexual abuse material online by supporting a pan-European network of Safer internet Centres. Promote measures aimed at detecting and combatting intentional disinformation spread, thereby increasing the Union\u2019s overall resilience; support a Union observatory for the digital platform economy as well as studies and outreach activities. The actions referred to in points 1 to 6 may be partly supported by European Digital Innovation Hubs through the same capacities developed to assist industry with their digital transformation (see point (II). II Initial and, where appropriate, subsequent actions under this objective related to the digital transformation of industry shall include: Contribution to the upscaling of the network of European Digital Innovation Hubs to ensure access to digital capacities for any business, in particular SMEs, in any region across the Union. Such contribution includes: 1. Access to common European data spaces and AI platforms and European HPC facilities for data analytics and compute intensive applications 2. Access to AI large scale testing facilities and to advanced cybersecurity tools 3. Access to advanced digital skills The actions referred to in the first subparagraph will be coordinated with, and will complement, the innovation actions in digital technologies supported, in particular, under Horizon Europe, as well as investments in European Digital Innovation Hubs supported under the ERDF. Grants for market replication may also be provided from the Programme, in compliance with state aid rules. Support for access to financing for further steps in their digital transformation will be achieved with financial instruments making use of the InvestEU Programme. (1) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients\u2019 rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). ANNEX II MEASURABLE INDICATORS TO MONITOR THE IMPLEMENTATION AND TO REPORT ON THE PROGRESS OF THE PROGRAMME TOWARDS THE ACHIEVEMENT OF ITS SPECIFIC OBJECTIVES Specific Objective 1 \u2013 High Performance Computing 1.1. The number of jointly procured HPC infrastructures 1.2. The usage of the exascale and post-exascale computers in total and by various stakeholder groups (universities, SMEs etc.) Specific Objective 2 \u2013 Artificial Intelligence 2.1. The total amount co-invested in testing and experimentation facilities 2.2. The usage of common European libraries or interfaces to libraries of algorithms, usage of common European data spaces and usage of testing and experimentation facilities related to actions under this Regulation 2.3. The number of cases for which organisations decide to integrate AI in their products, processes or services, as a result of the Programme Specific Objective 3 \u2013 Cybersecurity and Trust 3.1. The number of cybersecurity infrastructure, or tools, or both jointly procured (1) 3.2. The number of users and user communities getting access to European cybersecurity facilities Specific Objective 4 \u2013 Advanced Digital Skills 4.1. The number of persons who have received training to acquire advanced digital skills supported by the Programme 4.2. The number of enterprises, in particular SMEs, having difficulty recruiting ICT specialists 4.3. The number of people reporting an improved employment situation after the end of the training supported by the Programme Specific Objective 5 \u2013 Deployment and Best Use of Digital Capacity and Interoperability 5.1. The take-up of digital public services 5.2. Enterprises with high digital intensity score 5.3. The extent of the alignment of the National Interoperability Framework with the European Interoperability Framework 5.4. The number of businesses and public sector entities which have used the services of European Digital Innovation Hubs (1) \u2018Infrastructures\u2019 would typically mean a research or experimentation infrastructure such as testbeds, cyber ranges or computing/communication facilities. This could be either data and/or software only, or involve physical facilities. \u2019Tools\u2019 would typically mean a physical device and/or software/algorithm used to increase the security of ICT systems. Examples would be intrusion detection software or data resources allowing situational awareness of critical infrastructures. The Cybersecurity Competence Centre Regulation allows all sorts of procurement, not only joint procurement: by the European Cybersecurity Industrial, Technology and Research Competence Centre as a Union body; by others with the help of a Union grant; or by several parties. ANNEX III SYNERGIES WITH OTHER UNION PROGRAMMES 1. Synergies with Horizon Europe shall ensure that: (a) although several thematic areas addressed by the Programme and Horizon Europe converge, the type of actions to be supported, their expected outputs and their intervention logic are different and complementary; (b) Horizon Europe will provide extensive support for research, technological development, demonstration, piloting, proof-of-concept, testing and innovation including pre-commercial deployment of innovative digital technologies, in particular through: (i) a dedicated budget in the pillar \u2018Global Challenges and European Industrial Competitiveness\u2019 for the cluster \u2018Digital, Industry and Space\u2019 to develop enabling technologies (AI and robotics, Next Generation internet, HPC and Big Data, key digital technologies, combining digital with other technologies); (ii) support to research infrastructures under the pillar \u2018Excellent Science\u2019; (iii) the integration of digital across all the Global Challenges (health, security, energy and mobility, climate, etc.); and (iv) support for scale-up breakthrough innovations under the pillar \u2018Innovative Europe\u2019 (many of which will combine digital and physical technologies); (c) the Programme will invest in: (i) digital capacity building in HPC, AI, distributed ledger technologies (e.g. blockchain), cybersecurity and advanced digital skills; and (ii) national, regional and local deployment within an Union framework of digital capacities and the latest digital technologies in areas of public interest (such as health, public administration, justice and education) or market failure (such as the digitisation of businesses, in particular SMEs); (d) the capacities and infrastructures of the Programme are made available to the research and innovation community, including for actions supported through Horizon Europe, such as testing, experimentation and demonstrations across all sectors and disciplines; (e) as the development of novel digital technologies matures through Horizon Europe, those technologies will progressively be taken up and deployed by the Programme; (f) Horizon Europe initiatives for the development of skills and competencies curricula, including those delivered at the co-location centres of the EIT\u2019s KICs, are complemented by capacity-building in advanced digital skills supported by the Programme; (g) strong coordination mechanisms for programming and implementation are put in place, aligning all procedures for both programmes to the extent possible. Their governance structures will involve all Commission concerned services. 2. Synergies with Union programmes under shared management, including the ERDF, ESF+, the European Agricultural Fund for Rural Development and the European Maritime, Fisheries and Acquaculture Fund, shall ensure that: (a) arrangements for complementary funding from Union programmes under shared management and the Programme are used to support actions providing a bridge between smart specialisations and support to the digital transformation of the European economy and society; (b) the ERDF contributes to the development and strengthening of regional and local innovation ecosystems, industrial transformation, as well as the digital transformation of society and of public administrations, thereby also stimulating the implementation of the Tallinn Declaration on eGovernment. This includes support for the digital transformation of industry and the take-up of results, as well as the rolling out of novel technologies and innovative solutions. The Programme will complement and support the trans-national networking and mapping of digital capacities to make them accessible to SMEs and to make interoperable IT solutions accessible in all Union regions. 3. Synergies with the Connecting Europe Facility shall ensure that: (a) the Programme focuses on large-scale digital capacity and infrastructure building in the areas of HPC, AI, cybersecurity and advanced digital skills, aiming at the wide uptake and deployment across Europe of critical existing or tested innovative digital solutions within a Union framework in areas of public interest or market failure. The Programme is mainly to be implemented through coordinated and strategic investments with Member States, in particular through joint public procurement, in digital capacities to be shared across Europe and in Union-wide actions that support interoperability and standardisation as part of developing the Digital Single Market; (b) the capacities and infrastructures of the Programme are to be made available to the deployment of innovative new technologies and solutions in the field of mobility and transport. The Connecting Europe Facility is to support the roll-out and deployment of innovative new technologies and solutions in the field of mobility and transport; (c) coordination mechanisms are to be established, in particular through appropriate governance structures. 4. Synergies with InvestEU Programme shall ensure that: (a) support through market-based financing, including pursuing policy objectives under the Programme is provided under Regulation (EU) 2021/523; such market-based financing might be combined with the grant support; (b) access to financial instruments by businesses is facilitated by the support provided by European Digital Innovation Hubs. 5. Synergies with Erasmus+ shall ensure that: (a) the Programme supports the development and acquisition of the advanced digital skills needed for the deployment of cutting-edge technologies such as AI or HPC, in cooperation with relevant industries; (b) the advanced skills part of Erasmus+ complements the interventions of the Programme, addressing the acquisition of skills in all domains and at all levels through mobility experiences. 6. Synergies with Creative Europe established by a Regulation of the European Parliament and of the Council shall ensure that: (a) the MEDIA strand of Creative Europe supports initiatives that can generate real impact for cultural and creative sectors across Europe, helping them adapt to the digital transformation; (b) the Programme, inter alia, provides creators, creative industry and cultural sector in Europe with access to latest digital technologies from AI to advanced computing. 7. Synergies with other Union programmes and initiatives on competencies and skills shall be ensured.", "summary": "Digital Europe programme (2021\u20132027) Digital Europe programme (2021\u20132027) SUMMARY OF: Regulation (EU) 2021/694 establishing the Digital Europe Programme WHAT IS THE AIM OF THE REGULATION? The digital Europe programme is a European Union (EU) funding programme designed to bring digital technology to businesses, citizens and public administrations. It aims to: improve the EU\u2019s competitiveness in the global digital economy; contribute to bridging the digital divide across the EU and reinforcing its strategic autonomy; strengthen and promote Europe\u2019s capacities in key digital technology areas through large-scale deployment. KEY POINTS The programme runs from 1 January 2021 to 31 December 2027, i.e. the period of the multiannual financial framework. It is backed by an indicative allocation of more than \u20ac7.5 billion at 2021 prices and is implemented mainly under direct management by the European Commission. The regulation sets out 5 specific objectives aiming to widen Europe\u2019s capacities in key digital technology areas in the private sector and in areas of public interest. High-performance computing (\u20ac2,226,914,000) The operational objectives are primarily implemented through the European high-performance computing joint undertaking, set up under Regulation (EU) 2018/1488: easily accessible world-class exascale* supercomputing and data infrastructure for public and private users \u2014 particularly small and medium-sized enterprises (SMEs), easily accessible for research, in accordance with Regulation (EU) 2018/1488; an EU-wide high-performance computing ecosystem, covering science and industry, including hardware, software, applications, services, interconnections and digital skills; post-exascale infrastructure, including integration with quantum computing technologies and research infrastructures for computing science and encouraging the necessary hardware and software development. Artificial intelligence (AI) (\u20ac2,061,956,000) Supports the following operational objectives: core AI capacities and knowledge, including better quality data resources and exchange mechanisms, and libraries of algorithms, accessible to businesses \u2014 especially SMEs and start-ups \u2014 as well as citizens, not-for-profit organisations, research institutions, universities and public administrations; EU testing and experimentation facilities for commercial application and production systems to better integrate technologies within value chains. Cybersecurity and trust (\u20ac1,649,566,000) Supports the following operational objectives: advanced cybersecurity equipment, tools and data infrastructures, together with the EU Member States; knowledge, capacity and skills related to cybersecurity, including best practices; capabilities of the Member States and the private sector in support of the Cybersecurity of NIS directive (Directive (EU) 2016/1148); resilience, risk-awareness and at least basic levels of cybersecurity; better coordination between the civilian and defence cybersecurity spheres. Advanced digital skills (\u20ac577,347,000) The programme supports the development of advanced digital skills to: increase Europe\u2019s talent pool; bridge the digital divide and foster greater professionalism, especially in high-performance and cloud computing, big data analytics, cybersecurity, distributed ledger technologies (e.g. blockchain), quantum technologies, robotics and AI. Operational objectives include high-quality short-term and long-term training and courses, on-the-job training, and work placements (as appropriate) for students and the workforce, in particular in SMEs and in the public sector. Deployment and best use of digital capacity and interoperability (\u20ac1,072,217,000) Supports the following objectives: effective deployment of state-of-the-art digital technologies, such as HPC, AI and cybersecurity by actors in the public sector and in areas of public interest, such as health and care, education, judiciary, customs, transport, mobility, energy, environment, cultural and creative sectors; deployment and use of integrated and interoperable trans-European infrastructures and agreed digital standards in the public sector; use of solutions and frameworks including of open-source solutions by public administrations, businesses and citizens; easy access to digital technology testing and piloting of digital technologies for the public sector and EU industry, particularly SMEs; support uptake of advanced digital technologies, including HPC, AI, cybersecurity and blockchain, by the public sector and industry, particularly SMEs and start-ups; ensure continuous capacity at EU level to lead digital development, observing, analysing and adapting to fast-evolving digital trends, and sharing best practices; build a future European ecosystem for trusted data sharing and digital infrastructures. A network of European digital innovation hubs will provide access to technological expertise for businesses \u2014 in particular SMEs \u2014 and public administrations. These hubs will bring together industry, businesses and administrations in need of new technological solutions, and companies with market-ready solutions. The programme involves co-financing from Member States and, when needed, from the private sector. Grants under the programme may cover up to 100% of the eligible costs. The programme is also open to the participation of the following non-EU countries through association or partial association: European Free Trade Association (EFTA) members who are members of the European Economic Area (EEA); candidate countries and potential candidates; European Neighbourhood Policy countries; other non-EU countries by agreement. Digital Europe is complementary to other programmes supporting digital transition, such as Horizon Europe, which focuses on research and technological development, and the digital aspects of the Connecting Europe Facility. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND See also: The Digital Europe Programme (European Commission) High Performance Computing (European Commission) A European approach to artificial intelligence (European Commission) Cybersecurity in the Digital Europe programme (European Commission) Digital skills initiatives (European Commission). KEY TERMS Exascale: next-generation computing systems capable of executing 1018 (10 to the power of 18) floating operations per second. MAIN DOCUMENT Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, pp. 1\u201334). RELATED DOCUMENTS Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2014 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1\u201368). Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, pp. 11\u201322). Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, pp. 15\u201369). Council Regulation (EU) 2021/1173 of 13 July 2021 on establishing the European High Performance Computing Joint Undertaking and repealing Regulation (EU) 2018/1488 (OJ L 256, 19.7.2021, pp. 3\u201351). Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, pp. 1\u201330). last update 24.09.2021"}
{"article": "3.5.2021 EN Official Journal of the European Union L 153/1 REGULATION (EU) 2021/690 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 April 2021 establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114, Article 168(4)(b) and Articles 173 and 338 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The internal market is a cornerstone of the Union. Since its inception, it has proved a major contributor to growth, competitiveness and employment and it should continue benefitting all citizens and businesses equally. It has generated new opportunities and economies of scale for Union businesses, notably micro, small and medium-sized enterprises (SMEs), and has strengthened their industrial competitiveness. The internal market has contributed to the creation of jobs and has offered greater choice of high-quality products and services at lower prices for consumers. It continues to be an engine for building a more integrated market and a stronger, more balanced and fairer economy. It is one of the Union\u2019s major achievements and its best asset in an increasingly global world, as well as being a core element in achieving the green and digital transformation towards a sustainable economy, in response to the increasing pressures of climate change. (2) It is necessary for the internal market to adapt continuously to a rapidly changing environment of digital revolution and globalisation. The new era of digital innovation continues to provide opportunities for businesses and individuals, creates new products, services, processes and business models, and opportunities for the efficient production of high-quality statistics. It equally constitutes a challenge to regulation, enforcement, consumer protection and safety. (3) A substantial body of Union law underpins the functioning of the internal market. It concerns, in particular, competitiveness, standardisation, mutual recognition, conformity assessment, consumer protection and market surveillance. It also consists of rules on business, trade and financial transactions, on the plant, animal, food and feed area, on the production of European statistics and on the promotion of fair competition. That substantial body of Union law provides for the level playing field that is essential for the functioning of the internal market for the benefit of consumers and businesses. (4) Nevertheless, discriminatory, unjustified or disproportionate barriers to the proper functioning of the internal market remain and new obstacles emerge. Adopting rules is only a first step and making them work is as important. Current challenges connected with the enforcement of existing rules, barriers to free movement of goods and services, and low levels of cross-border public procurement limit the opportunities for businesses and consumers. Addressing such obstacles is ultimately a matter of citizens\u2019 trust in the Union, as well as in its capacity to deliver and its ability to create jobs and growth while protecting the public interest. (5) Previously, there have been separate programmes for Union action in the fields of competitiveness of enterprises, especially SMEs, consumer protection, customers and end-users in financial services, policymaking in financial services and in the plant, animal, food and feed area. Some additional activities have been financed directly under the internal market budget lines. It is now necessary to streamline and exploit synergies between various actions and provide for a more flexible, transparent, simplified and agile framework to finance activities aiming to achieve a well-functioning sustainable internal market. Therefore, a new programme should be established bringing together activities financed previously under those other programmes and other relevant budget lines. That programme should also include new initiatives which aim to improve the functioning of the internal market, while avoiding duplication with related Union programmes and actions. (6) The development, production and dissemination of European statistics pursuant to Regulation (EC) No 223/2009 of the European Parliament and of the Council (4) have been subject to a separate European Statistical Programme established by Regulation (EU) No 99/2013 of the European Parliament and of the Council (5). In order to provide continuity of production and dissemination of European statistics, the new programme should also include activities covered by the previous European Statistical Programme by providing a framework for the development, production and dissemination of European statistics pursuant to Regulation (EC) No 223/2009. The new programme should establish the financial framework for European statistics to provide high-quality, comparable and reliable European statistics, in order to underpin the design, implementation, monitoring and evaluation of all Union policies. Professional independence is a necessary prerequisite for the development, production and dissemination of European statistics. (7) It is therefore appropriate to establish a programme for improving the functioning of the internal market, the competitiveness and sustainability of enterprises, especially SMEs, standardisation, market surveillance and consumer protection, for the area of plants, animals, food and feed, and for European statistics (Single Market Programme) (the \u2018Programme\u2019). The Programme should be established for a period of seven years to align its duration with that of the multiannual financial framework for the years 2021 to 2027 laid down in Council Regulation (EU, Euratom) 2020/2093 (6). (8) The Programme should support the design, implementation and enforcement of Union legislation underpinning the proper functioning of the internal market. The Programme should support the creation of the right conditions to empower all actors of the internal market, including businesses, citizens, including consumers, and employees, representatives of civil society and public authorities. To that end, the Programme should aim to foster the competitiveness, capacity building and sustainability of enterprises, especially SMEs, including those operating in the tourism sector. The sustainability of enterprises is important to maintain their long-term competitiveness and contributes to the transition to a more economically, environmentally and socially sustainable Union, which should go hand in hand with digitalisation and engagement in sustainable business practices. The Programme should also support the enforcement of consumer protection and safety rules. It should also raise the awareness of businesses and individuals of their rights by providing them with the right tools, appropriate information and assistance, to make informed decisions and strengthen their participation in Union policy-making. Furthermore, the Programme should aim to enhance regulatory and administrative cooperation, notably through training programmes, the exchange of best practices and the building of knowledge and competence bases, including the use of strategic public procurement. The Programme should also aim to support the development of high-quality Union and international standards and rule-making, including through broad stakeholder involvement, which underpin the implementation of Union legislation. This should cover the field of financial reporting and audit, thereby contributing to the transparency and good-functioning of the Union\u2019s capital markets and to the enhancement of investor protection. The objective of the Programme should also be to support the implementation and enforcement of Union legislation providing for a high level of health for humans, animals and plants, protection of the well-being of people and the welfare of animals, food and feed safety whilst respecting the principles of sustainable development and ensuring a high level of consumer protection. Furthermore, the Programme should support the production of high-quality European statistics in accordance with the statistical principles set out in Regulation (EC) No 223/2009 and further elaborated in the European Statistics Code of Practice. (9) A modern internal market that is based on principles of fairness, transparency and mutual trust promotes competition and benefits consumers, businesses and employees. Making better use of the ever evolving internal market in services should help Union businesses create jobs and grow across borders, offer a wider choice of services at better prices, and maintain high standards for consumers and workers. To achieve this, the Programme should contribute to the better monitoring of internal market developments, as well as to the identification and the removal of remaining discriminatory, unjustified or disproportionate barriers, and ensure that the regulatory framework can accommodate all forms of innovation, including new technological developments and processes, service innovation business models, collaborative and social economy models, social innovation and non-technological innovation. (10) Regulatory obstacles in the internal market have been removed for many industrial products through prevention mechanisms, the adoption of common rules and, where no such Union rules exist, through the principle of mutual recognition. In areas where no Union legislation exists, the principle of mutual recognition applies, with the result that goods that are lawfully marketed in one Member State enjoy the right to free movement and can be sold in another Member State. Where the Member State concerned has grounds to oppose the marketing of the goods, it may impose a restriction, provided that such a restriction is non-discriminatory, justified by legitimate public interest objectives, as set out in Article 36 of the Treaty on the Functioning of the European Union (TFEU), or recognised by the case-law of the Court of Justice of the European Union as an overriding reason of public interest, and proportionate to the aim pursued. The inadequate application of the principle of mutual recognition, consisting, for example, in imposing unjustified or disproportionate restrictions, makes it harder for companies to access markets in other Member States. Despite the high degree of market integration in the area of goods, that situation leads to lost opportunities for the economy at large. The adoption of Regulation (EU) 2019/515 of the European Parliament and of the Council (7), is expected to boost the economic benefits in this area. The Programme should therefore aim to improve the application of the principle of mutual recognition in the area of goods, realising its full potential. It should also aim to reduce the number of illegal and non-compliant goods entering the market through targeted awareness raising and training, support for Product Contact Points referred to in Regulation (EU) 2019/515 and better cooperation among competent authorities for mutual recognition. (11) There are new regulatory and enforcement challenges relating to the rapidly changing environment of the digital revolution and concerning issues such as cybersecurity, data protection and privacy, internet of things or artificial intelligence and related ethical standards. Stringent rules on product safety and clarity with regard to liability are essential to ensure that Union citizens, including consumers, and businesses are able to benefit from appropriate protection in the event of damage. The Programme should therefore contribute to the rapid adaptation and better enforcement of a Union product liability regime which fosters innovation whilst ensuring the safety and security of users. (12) The placing on the market of products that are not compliant with Union law, including products imported from third countries, puts Union citizens, including consumers, as well as other end-users, at risk. Economic operators selling compliant products by traditional or electronic means face distorted competition from those who do not comply with the rules due to lack of knowledge, intentionally in order to gain a competitive advantage or as a result of the fragmentation of market surveillance across the Union. Market surveillance authorities are often underfunded and constrained by national boundaries, while entrepreneurs trade at Union or even global level. In particular, in the case of e-commerce, market surveillance authorities have great difficulties in tracing non-compliant products imported from third countries in order to identify the responsible economic operators within their jurisdiction. They also have great difficulties in conducting risk assessments and tests due to the lack of physical access to products. The Programme should therefore seek to strengthen compliance of products by raising awareness of applicable Union product safety rules, by intensifying compliance checks in line with Regulation (EU) 2019/1020 of the European Parliament and of the Council (8) and by promoting closer cross-border cooperation among enforcement authorities. The Programme should also contribute to the consolidation of the existing framework for market surveillance activities, encourage joint actions of market surveillance authorities from different Member States, improve the exchange of information and promote convergence and closer integration of market surveillance activities. The Programme should do this in particular by ensuring that the new requirements introduced by Regulation (EU) 2019/1020 are strictly enforced so as to prevent the sale of non-compliant products to consumers, as well as other end-users. The Programme should therefore strengthen the capacity of market surveillance authorities across the Union, contribute to greater homogeneity in the enforcement of rules between Member States and enable Member States to benefit equally from the internal market in terms of economic growth and sustainability. (13) While the Programme does not include objectives and actions supporting the protection of intellectual property rights, it should nevertheless be borne in mind that often counterfeit products do not comply with the requirements set out in the Union legislation on product safety and consumer protection, and present risks to the health and safety of consumers, particularly when such products are purchased online. The Programme should therefore increase synergies with other Union programmes in the field of the protection of intellectual property rights programmes, in particular the Customs Control Equipment Instrument, established under a Regulation of the European Parliament and of the Council establishing, as part of the Integrated Border Management Fund, the instrument for financial support for customs control equipment. (14) To facilitate the compliance of categories of harmonised products with higher inherent risk, the Union has put in place a system of accreditation for conformity assessment bodies, verifying their competence, impartiality and independence. It is essential that the conformity assessment bodies are reliable and competent, since they verify whether products meet the safety requirements before they are placed on the market. The main challenge now is to ensure that the accreditation system continues to represent the state of the art and that it is applied with the same stringency across the Union. The Programme should therefore support measures to ensure that conformity assessment bodies continue to fulfill their regulatory requirements, such as impartiality and independence, especially through the use of accreditation. Likewise, the Programme should also support measures to enhance the European accreditation system, in particular in new policy areas, by supporting the European cooperation for accreditation referred to in Regulation (EC) No 765/2008 of the European Parliament and of the Council (9). (15) Since, with the development of online trade and travel services, consumer markets recognise no borders, it is important to ensure that consumers residing in the Union can benefit from the same high level of protection when goods and services are imported from economic operators based in third countries, including when they are sold online. It should therefore be possible for the Programme, where necessary, to support cooperation with relevant bodies located in third countries, for example, with regard to the exchange of information on non-compliant products. (16) Public procurement is used by public authorities to ensure good value for the public money spent and to contribute to a more innovative, sustainable, inclusive and competitive internal market. This includes the application of evaluation criteria that not only identify the most economic advantageous offer, but also the most advantageous offer in terms of the greatest public value delivered when awarding tenders according to the \u2018best price-quality ratio\u2019. Where this is in accordance with applicable Union law, environmental, fair trade and social aspects should be taken into account and a division of tenders into lots should be promoted for large infrastructure projects. Directives 2014/23/EU (10), 2014/24/EU (11) and 2014/25/EU (12) of the European Parliament and of the Council provide the legal framework for the integration and effective functioning of the public procurement markets representing 14 % of the Union\u2019s gross domestic product, for the benefit of public authorities, businesses and citizens, including consumers. Properly implemented public procurement rules are a crucial tool for strengthening the internal market and for boosting the growth of Union companies and Union jobs. The Programme should therefore support measures to ensure a wider uptake of strategic public procurement, the professionalisation of public buyers, the facilitation and improvement of access to procurement markets for SMEs, in particular through advisory services and training, an increase in transparency, integrity and better data, the boosting of the digital transformation of procurement and the promotion of joint procurement, through strengthening a partnership approach with the Member States, the improvement of data gathering and data analysis, including through the development of dedicated IT tools, as well as to ensure support for the exchange of experiences and good practices, the referencing of European and international standards, the provision of guidance, the pursuit of beneficial trade agreements, the strengthening of cooperation among national authorities and the launching of pilot projects. (17) In order to meet the objectives of the Programme and to facilitate the lives of citizens and businesses, increasingly-digitalised and fully-accessible, high-quality, user-centric public services need to be put in place. E-administration and e-government efforts also need to be boosted, while ensuring appropriate data protection and privacy. That implies that public administrations will need to engage in the co-creation of those public services with citizens and businesses. Moreover, the continuous and steady increase of cross-border activities in the internal market requires up-to-date, accurate and easy to understand information on the rights of businesses and citizens to be available. This means that simplified information explaining the administrative formalities should be displayed. In addition, providing legal advice and helping to solve problems which occur at a cross-national level is essential. Furthermore, public authorities should be supported in their efforts to achieve those objectives, for example by connecting national administrations in a simple and efficient manner, as well as by providing information and facilitating an exchange of information explaining how the internal market works on the ground. The existing internal market governance tools already play an important role in that respect and their quality, visibility, transparency and reliability should be further enhanced. The Programme should therefore support the following, existing, internal market governance tools: the Your Europe Portal which should become a backbone of the upcoming Single Digital Gateway, the Your Europe Advice, SOLVIT, the Internal Market Information System and the Single Market Scoreboard. (18) The Programme should support the development of the Union regulatory framework in the areas of company law and corporate governance, and contract law, with a view to making businesses, especially SMEs, more efficient and competitive, while providing protection for stakeholders affected by company operations, and with a view to reacting to emerging policy challenges. It should also ensure the appropriate evaluation, implementation and enforcement of the relevant acquis, inform and assist stakeholders and promote information exchange in the area. The Programme should further support the Commission\u2019s initiatives in support of a clear and well-adapted legal framework for the data economy and innovation. Those initiatives are necessary to enhance legal certainty with regard to contractual and extra contractual obligations, in particular with regard to liability, security, ethics and privacy in the context of emerging technologies, such as the internet of things, artificial intelligence, robotics and 3D printing. The Programme should aim to stimulate the development of data-driven business, as such business will be decisive for the performance of the Union economy in global competition. (19) The Programme should also promote the correct and full implementation and application by the Member States of the Union legal framework for anti-money laundering and countering terrorism financing and the development of future policies to address new challenges in those fields. It should also support relevant activities of international organisations of European interest, such as the Committee of Experts on the Evaluation of Anti-Money Laundering Measures and the Financing of Terrorism of the Council of Europe. (20) The objective of implementing and developing the internal market in the area of financial services, financial stability and the Capital Markets Union, including sustainable finance, is highly dependant on the evidence based policy measures taken by the Union. The Commission should play an active role in achieving that objective, by constantly monitoring financial markets and financial stability, assessing the implementation of Union legislation by Member States, evaluating whether the existing legislation is fit for purpose and, when new risks emerge, identifying potential areas of action, all with the continuous involvement of stakeholders, throughout the policy cycle. Such activities rely on the production of analyses, studies, training materials, surveys, conformity assessments, evaluations and high-quality statistics and are supported by IT systems and communication tools. (21) The TFEU includes a system of rules ensuring that competition is not distorted in the internal market. The Programme should contribute to the Union\u2019s competition policy, including by improving and reinforcing the cooperation with networks, and with national authorities and courts, and by strengthening international cooperation, as well as by ensuring an outreach to a wider group of stakeholders in communicating and explaining the rights, benefits and obligations of the Union\u2019s competition policy. The Programme should also help to enhance the analysis and assessment of market developments, including through the use of sector inquiries and other market investigation tools, as well as by systematic sharing of information and best practices within the European Competition Network. This should contribute to fair competition and a level playing field, including at global level, and empower businesses, especially SMEs, and consumers to reap the benefits of the internal market. (22) The Programme needs, in particular, to tackle the radical implications for competition and the functioning of the internal market resulting from the ongoing green and digital transition of the economy and business environment, in particular through the exponential growth in the amount and use of data, taking account of the increasing recourse to artificial intelligence, big data algorithms and other IT tools and expertise by companies. It is also essential that the Programme supports networks and fosters a wider and deeper cooperation with Member States and their authorities and courts, since undistorted competition and the functioning of the internal market depend critically on action by those entities. In view of the particular role of competition policy in preventing harm to the internal market resulting from anti-competitive conduct beyond the Union\u2019s border, the Programme should also support cooperation with third country authorities, as appropriate. Finally, widening outreach activities is necessary in order to allow more citizens and businesses to reap the full benefits of fair competition in the internal market. This should support efforts to better demonstrate the benefits of the Union\u2019s competition policy to Union citizens, including through engagement with representatives of civil society groups and relevant stakeholders. Flexibility is expected to be needed in the implementation of the competition part of the Programme to respond to evolving needs that are affected by dynamic and rapid developments in the conditions of competition in the internal market the pace and magnitude of which are difficult to estimate. Those developments relate in particular to digitalisation, artificial intelligence, algorithms, big data, cybersecurity and forensic technology. (23) Strengthening the competitiveness and sustainability of Union enterprises while ensuring an effective level playing field and an open and competitive internal market is of the utmost importance. SMEs are the engine of the Union economy. They make up 99,8 % of all businesses in the Union, provide two thirds of jobs, and contribute substantially to the creation of new quality jobs in all sectors with a regional and local dimension, and hence to the creation of social cohesion. SMEs are instrumental in the modernisation of industry and in the green and digital transformation of the economy, including the achievement of climate neutrality. The Programme should therefore support their efforts to increase resource-efficiency and to develop environmentally friendly high-quality products and services. In doing so, the Programme should also contribute to improve SMEs competitiveness on the global market. (24) SMEs share common challenges that do not affect larger firms to the same extent. Those common challenges include obtaining finance, recruiting a skilled work force, alleviating their administrative burden, taking up creativity and innovation, inter alia, through public procurement, and accessing global markets and value chains in order to develop their internationalisation activities. The Programme should address such market failures proportionally, while not unduly distorting competition in the internal market. The Programme should also take account of the particular needs of specific types of SMEs, such as micro enterprises, SMEs engaged in services and SMEs engaged in craft activities, as well as SMEs consisting of the self-employed, members of the liberal professions and social economy enterprises. Social economy enterprises in the Union include different types of enterprises and entities falling within the social economy, such as cooperatives, mutual societies, non-profit associations, foundations, social enterprises and other forms of enterprises. Since their primary focus is on creating shared value and social impact for people rather than on realising profits, they are able to act as an engine of social innovation, transparent governance and solidarity, by reinvesting the majority of their profits or surpluses in their objectives. Attention should also be paid to the particular needs of potential new entrepreneurs, such as young and female entrepreneurs, older people and persons with disabilities. (25) The Programme should take into account SMEs, as defined in Commission Recommendation 2003/361/EC (13). When applying this Regulation in respect of SMEs, the Commission should consult all relevant stakeholders, including the public and private organisations representing SMEs and the Trade Promotion Organisations of the Member States. (26) The Programme should support and promote a culture of innovation, developing industrial ecosystems capable of encouraging business start-ups and SME growth, focusing on all SMEs able to meet the challenges of the green and digital transition and of an increasingly competitive and fast-moving environment. The Programme should seek to support the innovation uptake process by promoting new collaborative business models, networking and the sharing of knowledge and resources, including across European partnerships of clusters and business network organisations. (27) When establishing work programmes for providing support to SMEs, the strategic provisions of the SME strategy and the Small Business Act as well as the context in which SMEs operate, as described in the SME performance review, should be taken into account. Attention should also be paid to the SME Envoy Network. (28) Many of the Union\u2019s competitiveness problems involve SMEs\u2019 difficulties in obtaining access to finance. Those difficulties arise because SMEs struggle to demonstrate their credit-worthiness and have insufficient assets as security for lenders (i.e. collateral/guarantees), or because they lack awareness of the mechanisms to support their activities that already exist at Union, national or local level. Additional financing challenges arise from SMEs\u2019 need to stay competitive by engaging, inter alia, in innovation uptake activities, digitalisation and internationalisation, as well as in the up- and re-skilling of their workforce. Limited access to finance has a negative effect on businesses creation, growth and survival rates, as well as on the readiness of new entrepreneurs to take over viable companies in the context of a business succession. (29) The lack of skills is a major obstacle to the growth of enterprise in the Union. To foster entrepreneurship in the Union and support the growth of SMEs and their digital and green transition, the Programme should promote and facilitate access to skills and mentoring schemes for SMEs, and in particular the development of technological, entrepreneurial and managerial skills. In doing so, the Commission should coordinate with initiatives undertaken in other Union, national and regional programmes to increase synergies and avoid duplication. (30) To overcome the market failures and to ensure that SMEs, including start-ups and scale-ups, continue to play their role as the foundation of the competitiveness of the Union\u2019s economy, SMEs need extra support in the form of debt and equity instruments established under the SME policy window of the InvestEU Fund established by Regulation (EU) 2021/523 of the European Parliament and of the Council (14). The Loan Guarantee Facility, put in place under Regulation (EU) No 1287/2013 of the European Parliament and of the Council (15), is of proven added value and is expected to make a positive contribution to at least 500 000 SMEs. More attention could be paid to increasing awareness, on the part of potential beneficiaries, of the availability of the InvestEU Programme for SMEs. (31) Actions under the Programme should seek to achieve its policy objectives not only through grants, but also through facilitating access to financial instruments and budgetary guarantees established under the SME policy window of the InvestEU Fund and should enhance synergies with other Union programmes. All actions should have clear Union added value. (32) The Programme should provide effective support for SMEs throughout their life-cycle, providing assistance ranging from helping SMEs to find partners for joint projects to commercialisation and access to the market, capacity-building and encouraging the cooperation along clusters and business network organisations. It should also support the green and digital transition of SMEs and build on the unique knowledge and expertise developed with regard to SMEs, as well as on long experience working with Union, national and regional stakeholders. That support should build on the experience of the Enterprise Europe Network (EEN) as a \u2018one-stop shop\u2019 to improve the competitiveness of SMEs and to develop their business in the internal market and beyond. The EEN continues to deliver services on behalf of other Union programmes, notably Horizon Europe established by Regulation (EU) 2021/695 of the European Parliament and of the Council (16), using the financial resources of those programmes. The EEN should also facilitate enhanced participation of SMEs in the development of internal market policy initiatives, such as public procurement and standardisation processes. The EEN should improve cooperation with European Digital Innovation Hubs under the Digital Europe Programme established by Regulation (EU) 2021/694 of the European Parliament and of the Council (17) and the InvestEU Advisory Hub. In addition, the successful mentoring scheme \u2013 Erasmus for Young Entrepreneurs \u2013 should remain the tool to enable new or aspiring entrepreneurs to gain business and managerial experience by being matched with and by learning from an experienced entrepreneur from another country, thereby strengthening their entrepreneurial talents. The Programme should extend its geographical coverage and offer a wider range of matching possibilities to entrepreneurs in complementarity with other Union initiatives where relevant. (33) Additional efforts should be made to reduce the administrative burden and to make the initiatives of the Programme more accessible by reducing the costs to SMEs of complicated application processes and participation requirements. In that context, the EEN should be the main information point for SMEs interested in accessing Union funds, functioning as a \u2018one-stop shop\u2019, and providing them with tailored guidance. It is important to build on the experiences of the existing measures supporting SMEs, whilst remaining open to adapting them in the light of the changing conditions for SMEs in the internal market, especially those regarding digitalisation and the regulatory burden. (34) Since clusters offer favourable and resilient business environments, they are a strategic tool for supporting the competitiveness and scaling-up of SMEs. They can facilitate the green and digital transition of industry, including services, and strengthen the economic development of regions through the creation of growth and jobs. It is important that Joint Cluster Initiatives achieve critical mass since this will accelerate the growth of SMEs. By connecting specialised industrial eco-systems, clusters create new business opportunities for SMEs and integrate them better in Union and global strategic value chains. Support should be provided for the development of transnational and interregional partnership strategies and the implementation of joint activities, supported by the European Cluster Collaboration Platform and its European Resource-Efficiency Knowledge Centre. Support should also include helping SMEs to team up with SMEs from third countries. Sustainable partnering should be encouraged by providing continuation funding if performance and participation milestones are reached. Direct support to SMEs should be channelled through cluster organisations for the following: promoting the uptake of advanced technologies, new business models, low-carbon and resource-efficient solutions, creativity and design, the upgrading of skills, the attraction of talent, the acceleration of entrepreneurship, and internationalisation. Other specialised SME support actors should be associated with that direct support to SMEs in order to facilitate industrial transformation and the implementation of smart specialisation strategies. The Programme should therefore contribute to and build links with the Union\u2019s innovation hubs, in particular its digital innovation hubs, and investments made under Cohesion Policy and Horizon Europe. Synergies with the Erasmus+ programme established by Regulation (EU) XXXX/XXX of the European Parliament and of the Council (18) could also be explored. (35) The Programme should help to strengthen the relationship between businesses, especially SMEs, and universities, research centres and other institutions involved in knowledge creation and dissemination. This relationship could help to improve the ability of businesses to tackle the strategic challenges posed by the new international context. (36) SMEs, owing to their smaller size, face specific obstacles to growth. It is particularly difficult for them to grow and scale up some of their business activities. Based on the success of, and the lessons learned, and experiences from the SME Instrument and the Union cluster projects for new industrial value chains under Horizon 2020, established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council (19), the Programme should provide support for scaling-up activities by SMEs at all crucial stages in their development, including support for internationalisation, the uptake of innovation and commercialisation activities. That support would complement support from the European Innovation Council under Horizon Europe, which will mainly focus on breakthrough and disruptive innovation, and therefore on innovative SMEs, targeting especially market-creating innovation, while also supporting all types of innovation, including incremental innovation. (37) Creativity and all forms of innovation, including innovation in pursuit of enhanced resource and energy efficiency, are crucial for the competitiveness of the Union\u2019s industrial value chains. They represent catalysts for the modernisation of the business and industry sectors and contribute to smart, inclusive sustainable growth. However, uptake by SMEs is still lagging behind. The Programme should therefore support targeted actions, networks and partnerships for creativity-driven innovation to enable SMEs to master the green and digital transition throughout the industrial value chains and ecosystems. (38) European standards play an important role in the internal market. They are of vital interest for the competitiveness of undertakings and especially SMEs. European standards are also a crucial tool for supporting Union legislation and policies in a number of key areas that aim to foster the green and digital transition, such as energy, climate change and environmental protection, information and communication technology, sustainable use and recycling of resources, innovation, product safety, consumer protection, worker\u2019s safety and working conditions and ageing population, thereby positively contributing to the society as a whole. In order to maximise their contribution, experience has shown that the speed and timeliness of the elaboration of standards need to be improved and more effort needs to be made to better involve all relevant stakeholders, including those representing consumers. (39) European standardisation activities are governed by Regulation (EU) No 1025/2012 of the European Parliament and of the Council (20) and implemented through a long-standing public-private-partnership that is fundamental to achieving the objectives set in that Regulation, as well as those contained in general and sectorial Union standardisation policies. (40) A well-functioning common financial and non-financial reporting framework is essential for the internal market, for the effective functioning of the financial markets and for the realisation of the integrated market for financial services in the context of the Banking Union and the Capital Markets Union. (41) In accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council (21), International Financial Reporting Standards (IFRS) adopted by the International Accounting Standards Board and related interpretations from the IFRS Interpretations Committee are to be incorporated into Union law in order to be applied by companies with securities listed on a regulated market in the Union only if IFRS meet the requirements set out in that Regulation, including the requirement that accounts give a \u2018true and fair view\u2019 as provided for in Directive 2013/34/EU of the European Parliament and of the Council (22) and that they are conducive to the European public good. Such international accounting standards need to be developed in a transparent and democratically accountable way. IFRS therefore play a major role in the functioning of the internal market and the Union therefore has a direct interest in ensuring that the process by which IFRS are developed and approved results in standards that are consistent with the requirements of the legal framework of the internal market. It is therefore important to establish in the Programme appropriate funding arrangements for the IFRS Foundation. (42) Taking into account the European Financial Reporting Advisory Group\u2019s (EFRAG) role in assessing whether IFRS comply with the requirement of Union law and policy, as laid down in Regulation (EC) No 1606/2002, it is also necessary for the Union to ensure that the funding of EFRAG is stable and therefore to contribute to that funding via the Programme. The technical work of EFRAG should focus on providing the Commission with technical advice on the endorsement of IFRS as well as on the appropriate level of Union participation in the process of developing those IFRS, and should ensure that the interests of the Union are adequately taken into account in the international standard-setting process. Those interests should include the notion of \u2018prudence\u2019, the maintenance of the requirement of a \u2018true and fair view\u2019, as laid down in Directive 2013/34/EU, and of the European public good, as laid down in Regulation (EC) No 1606/2002, taking into account the impact of IFRS on financial stability and the economy. The European Corporate Reporting Lab has been established as part of EFRAG, to promote innovation and the development of best practices in corporate reporting. It provides a forum in which companies and investors can share best practices, notably in the field of non-financial and sustainability reporting. Building on this work, EFRAG should also contribute to the development of non-financial reporting standards. (43) In the field of statutory audit, the Public Interest Oversight Board (PIOB) was created in 2005 by the Monitoring Group, an international organisation responsible for monitoring the governance reform of the International Federation of Accountants (IFAC). The role of the PIOB is to oversee the process leading to the adoption of International Standards on Auditing (ISAs) and other public interest activities of the IFAC. It is possible for ISAs to be adopted for application in the Union provided, in particular, that they have been developed in accordance with due process, public oversight and transparency, as required under Article 26 of Directive 2006/43/EC of the European Parliament and of the Council (23). Considering the introduction of ISAs in the Union and the key role of the PIOB in ensuring that they fulfil the requirements laid down in Directive 2006/43/EC, it is therefore important to establish in the Programme appropriate funding arrangements for the PIOB. (44) The Union contributes to ensuring a high level of consumer protection, empowering consumers and putting them at the heart of the internal market by supporting and complementing Member States\u2019 policies in seeking to ensure that citizens when acting as consumers can fully reap the benefits of the internal market and that, in so doing, their safety and legal and economic interests are properly protected by means of concrete actions. It is also necessary for the Union to ensure that consumer and product safety laws are properly and equally enforced on the ground and that businesses enjoy a level playing field and therefore that competition in the internal market is fair. Moreover, it is necessary to empower, encourage and assist consumers to make sustainable and informed choices, thus contributing to a sustainable, energy and resource efficient and circular economy. (45) The Programme should aim to raise awareness, on the part of consumers, businesses, representatives of civil society and authorities, of Union consumer and safety laws. It should also empower consumers and their representative organisations at national level and at Union level. It should do this in particular by supporting the European consumer organisation BEUC (Bureau Europ\u00e9en des Unions de Consommateurs), which is a long-established and well-recognised non-governmental organisation representing the interests of consumers in relation to all relevant Union policies, which has enabled that organisation to build enhanced synergies to strengthen consumer advocacy. It also should do that in particular by supporting the European Association for the Coordination of Consumer Representation in Standardisation (ANEC), which represents consumers interest in relation to standardisation issues. In doing so, particular attention should be paid to new market needs regarding the promotion of sustainable consumption by targeting in particular actions combatting those planned obsolescence practices that are misleading and other misleading practices such as false environmental claims, by informing consumers better about product durability and reparability. Particular attention should also be paid to preventing the vulnerabilities and to meeting the challenges created by the digitalisation of the economy, in relation to, for example, connected products, the internet of things, artificial intelligence and the use of algorithms, and the development of new consumption patterns and business models. The Programme should support actions for the development of relevant information on markets, including the publication of the Union consumer scoreboards. (46) The Programme should support national competent authorities, including those responsible for monitoring product safety, which cooperate notably via the Union\u2019s rapid alert system for dangerous products. It should also support the enforcement of Directive 2001/95/EC of the European Parliament and of the Council (24) and Regulation (EC) No 765/2008 regarding consumer protection and product safety, and the Consumer Protection Cooperation Network and international cooperation between the relevant authorities in third countries and in the Union. The Programme should also aim to ensure access for all consumers and traders to quality out-of-court dispute resolution, online dispute resolution and information on the process for participating in actions seeking redress. (47) The Programme should also support the European Consumer Centres Network, which assists consumers to obtain the benefit of their Union consumer rights when they purchase goods and services cross border in the internal market and European Economic Area, either on-line or when travelling. The network, which is 29 centres strong and which has been jointly funded by the Union consumer programmes for more than 15 years, has proven its added value in relation to strengthening consumers\u2019 and traders\u2019 trust in the internal market. It deals with more than 120 000 consumers\u2019 requests per year and reaches millions of citizens via its press and online information activities. It is one of the most valued citizens\u2019 assistance networks in the Union and most of its centres host contact points offering advice on aspects of internal market law, such as the Directive 2006/123/EC of the European Parliament and of the Council (25). Evaluations have stressed the importance of the centres continuing their operations. The European Consumer Centres Network can also be an important source of information about challenges and problems that consumers encounter at local level, which are relevant for Union policy-making and for the protection of consumers interests. There are also plans for the network to develop reciprocity arrangements with similar bodies in third countries. (48) Directives 98/6/EC (26), 2005/29/EC (27), 2011/83/EU (28), (EU) 2019/2161 (29)and (EU) 2020/1828 (30) of the European Parliament and of the Council have been adopted to ensure, inter alia, the equal treatment of consumers across the internal market in relation to cross-border issues, such as sales of non-compliant products in the motor vehicles sector, dual quality standards for products, or the problems experienced by passengers in the event of flight cancellations or long flight delays. They also aim to strengthen the enforcement capacities of Member States, enhance product safety and increase international cooperation and new possibilities for redress notably through representative actions by qualified entities. In May 2017, the Commission carried out a fitness check of Union consumer and marketing law, which exposed the need to better enforce rules and facilitate redress when consumers have been harmed by breaches to consumer laws. In view of that fitness check, supporting the full implementation of those Directives and actions and promoting their cross border enforcement should therefore be a priority. (49) Citizens are particularly affected by the functioning of financial markets and should, therefore, be further informed about relevant rights, risks and benefits. Financial markets are a key component of the internal market and require a solid framework for regulation and supervision that ensures not only financial stability and a sustainable economy, but also provides a high level of protection to consumers and other financial services end-users, including retail investors, savers, insurance policyholders, pension fund members and beneficiaries, individual shareholders, borrowers and SMEs. The Programme should contribute to enhancing the capacity of consumers and other financial services end-users to participate in policymaking, including through the production and dissemination of clear, complete and user-friendly information about products provided in the financial markets. (50) The Programme should therefore continue to support the specific activities covered by the 2017-2020 Capacity-Building Programme enhancing the involvement of consumers and other financial services end-users in Union policy-making, as set out in Regulation (EU) 2017/826 of the European Parliament and of the Council (31), which continued the pilot project and preparatory action of the years 2012-2017. This is necessary in order to ensure that policy-makers are aware of the views of stakeholders other than financial sector professionals and to ensure a better representation of the interests of consumers and other financial services end-users. The Programme should continuously develop its methodology and best practices on how to increase the engagement of consumers and financial services end-users in order to identify issues relevant for Union policy-making and ensure that the interests of consumers in the area of financial services are protected. This should improve financial services policies, especially those that aim to foster better public understanding of the issues at stake in financial regulation and enhanced financial literacy. (51) In the context of the pilot project and preparatory action of the years 2012-2017, the Commission awarded grants to two organisations following an annual open call for proposals. The two organisations are Finance Watch, set up with Union grants in 2011 as an international non-profit association under Belgian law, and Better Finance, which is the outcome of successive re-organisations and rebrandings of pre-existing European federations of investors and shareholders since 2009. The Capacity-Building Programme established under Regulation (EU) 2017/826, identifies those same two organisations as sole beneficiaries. It is therefore necessary to continue to co-finance those organisations in the context of the Programme. However, this financing should be subject to a thorough evaluation of the effectiveness and impact achieved towards fulfilling the objectives pursued. In this respect, if other potential beneficiaries emerge that have among their primary objectives and activities representing the interests of consumers and end-users at Union level, and that have, through their membership, a broad geographical coverage and range of interests, a call for applicants proposals should be open to them. (52) A high level of health protection in the area of plants, animals, food and feed is necessary to protect consumers as well as to allow the internal market to operate efficiently. A safe and sustainable food supply chain is a prerequisite for society and the internal market to function. Preventing cross-border health crises and food scares is of the utmost importance, since they disrupt the functioning of the internal market by limiting the movements of persons and goods and disrupting production and consumption. Therefore, the Programme should support concrete actions, such as establishing emergency measures in the event of crisis situations affecting animal and plant health. (53) The general objective of Union law in the area of plants, animals, food and feed is to safeguard a high level of health for humans, animals and plants along the food chain, to support the improvement of the welfare of animals, to contribute to a high level of protection and information for consumers and a high level of protection of the environment, including for the preservation of biodiversity and taking into account situations caused by potential climate change impacts in the Member States, while improving the sustainability of food and feed production and contributing to food security and affordable prices, cutting food waste, increasing the quality standards of products across the Union, and enhancing the competitiveness of the Union food and feed industry and the creation of jobs, including by stimulating research and innovation. (54) In view of the specific nature of the actions concerning a high level of health for humans, animals and plants, special eligibility criteria concerning provision of grants and use of public procurement need to be laid down in this Regulation. In particular, by way of exception to the principle of non-retroactivity in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (32) (the \u2018Financial Regulation\u2019), the costs for the emergency measures, due to their urgent and unforeseeable nature, should be eligible, including costs incurred as a result of a suspected occurrence of a disease or pest, provided that the occurrence is subsequently confirmed and notified to the Commission. The corresponding budgetary commitments and the payment of eligible expenditure should be made by the Commission, after signature of the legal commitments and after assessment of the payment applications submitted by the Member States. Costs should also be eligible for surveillance, prevention and protection measures taken in the case of a direct threat to the health status of the Union as a result of the occurrence or development, in the territory of a third country, a Member State or its overseas countries and territories, of certain animal diseases and zoonoses as well as for protection measures taken or other relevant activities carried out in support of the health status of plants in the Union. (55) In view of the increasing globalisation of the plant, animal, food and feed area, official controls carried out by the Member States are an essential tool for verifying and monitoring that relevant Union requirements are being implemented, complied with and enforced, including in respect of imports. The effectiveness and efficiency of official control systems is vital for maintaining a high level of safety along the food chain, as well as consumer confidence, whilst ensuring a high level of protection of the environment and of animal welfare. Union financial support should be made available for such control measures. In particular, a financial contribution should be available to European Union reference laboratories in order to help them bear the costs arising from the implementation of work programmes approved by the Commission, and may be available to national plant and animal health reference laboratories, which according to Regulation (EU) 2017/625 of the European Parliament and of the Council (33) are to benefit from adequate financial resources provided by Member States, on condition that it can be clearly shown that the actions carried out represent Union added value and that sufficient funding is available under the Programme to support those actions. Moreover, since the effectiveness of official controls also depends on the availability to the control authorities of well trained staff with an appropriate knowledge of Union law, the Union should be able to contribute to their training and relevant exchange programmes organised by competent authorities. (56) Anti-microbial resistance is a growing health problem in the Union and worldwide. Therefore, it should be possible to co-finance measures to support the fight against anti-microbial resistance under the Programme. (57) High-quality European statistics developed, produced and disseminated under the Programme pursuant to Regulation (EC) No 223/2009 are essential for evidence-based decision making. European statistics should be available in a timely manner and should contribute to the implementation of Union policies referred to in TFEU, notably strengthened and integrated economic governance, social, economic and territorial cohesion, sustainable development, agricultural policy, the social dimension of Europe and globalisation. (58) European statistics are indispensable for Union decision-making and for measuring the performance and impact of Union initiatives. Therefore, it is important to ensure the continued provision and development of European statistics, taking a Union-wide approach and going beyond an internal market perspective in order to cover all Union activities and policy areas, including empowering businesses and citizens to take informed decisions. (59) In view of its horizontal character, the framework for the development, production and dissemination of European statistics within the meaning of Regulation (EC) No 223/2009 is subject to specific requirements, and in particular those laid down in that Regulation, with regard to respect for statistical principles, as well as the functioning of the European Statistical System and its governance, including the role and tasks assigned to the European Statistical System Committee and to the Commission (Eurostat), the establishment and implementation of the programming of the statistical activities. (60) The draft part of the Programme regarding the framework for the development, production and dissemination of European statistics has been submitted for prior examination to the European Statistical System Committee in accordance with Regulation (EC) No 223/2009. (61) The Union and Member States are committed to being frontrunners in implementing the United Nations 2030 Agenda for Sustainable Development. By contributing to the achievement of the 2030 Agenda, the Union and Member States will foster a stronger, more sustainable, inclusive, secure and prosperous Europe. The Programme should contribute to the implementation of the 2030 Agenda, including by balancing the economic, social and environmental dimensions of sustainable development, and, to that end, giving a clear and visible commitment to the mainstreaming of the United Nations Sustainable Development Goals. (62) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement adopted under the United Nations Framework Convention on Climate Change and the United Nations Sustainable Development Goals, this Programme is intended to contribute to mainstreaming climate actions and to the achievement of the overall target of 30 % of Union budget expenditure supporting climate objectives. Relevant actions will be identified during the Programme\u2019s preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. In this context the Programme should support activities that respect the climate and environmental standards and priorities of the Union, and would do no significant harm to environmental objectives within the meaning of Regulation (EU) 2020/852 of the European Parliament and of the Council (34). (63) This Regulation lays down a financial envelope for the Programme which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (35), for the European Parliament and the Council during the annual budgetary procedure. (64) The Agreement on the European Economic Area (36) provides for cooperation in the fields subject to the Programme between the Union and its Member States, on the one hand, and the countries of the European Free Trade Association participating in the European Economic Area (EEA), on the other. It should also be possible to open the Programme to participation by acceding countries, candidate countries and potential candidates, European Neighbourhood Policy countries and other third countries. In addition, in the field of European statistics, the Programme should be open to Switzerland in accordance with the Agreement between the European Community and the Swiss Confederation on cooperation in the field of statistics (37). (65) Third countries which are members of the EEA may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area, which provides for the implementation of the programmes on the basis of a decision under that Agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, the European Anti-Fraud Office (OLAF) and the Court of Auditors to comprehensively exercise their respective competences. (66) The Financial Regulation applies to this Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (67) The actions implemented under the predecessor programmes and budget lines have proven to be adequate and should be retained. The new actions introduced under the Programme aim in particular to reinforce the well-functioning internal market. In order to provide more simplicity and flexibility in the execution of the Programme and thereby to better deliver on its objectives, the actions should be defined only in terms of overall, generic categories. Lists of indicative activities concerning specific objectives in the areas of competitiveness and consumer protection, or specific activities stemming from regulatory requirements, such as specific activities in the areas of standardisation, market surveillance, the plant, animal, food and feed area and European statistics should also be included in the Programme. (68) It is necessary to specify certain categories of entities eligible for funding as well as those entities which should be eligible for funding without a call for proposals. (69) Considering the increasing interconnectivity and digitalisation of the global economy, the Programme should continue to offer the possibility of involving external experts, such as officials of third countries, representatives of international organisations or economic operators in certain activities. (70) It is necessary to indicate specific criteria concerning co-financing rules and eligible costs. Since, for some of the specific objectives, it might be necessary to finance eligible costs in full, it should be possible to derogate from Article 190 of the Financial Regulation. (71) Pursuant to Article 193(2), second subparagraph, point (a) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. While in such cases the costs incurred prior to the date of submission of the grant application would in principle not be eligible, this should exceptionally be possible taking into account the delayed entry into force of this Programme and in order to avoid any disruption in Union support, which could be prejudicial to the Union\u2019s interests. Therefore, where this is necessary to ensure continuity and during a limited period of time at the beginning of the multi-annual financial framework 2021-2027, costs in respect of an action which has already begun should be eligible from 1 January 2021, even if those costs were incurred prior to the date of submission of the grant application. For the same reasons and under the same conditions and as a derogation from Article 193(4) of the Financial Regulation the costs incurred prior to the date of submission of the grant application should be eligible in the case of operating grants. (72) In line with the Commission\u2019s commitment, set out in its Communication of 19 October 2010 entitled \u2018The EU Budget Review\u2019, and in order to provide for coherence and simplification of funding programmes, resources should be shared with other Union funding instruments if the envisaged actions under the Programme pursue objectives which are common to various funding instruments, excluding however double financing. (73) The Programme should contribute to the overall support addressing specific needs of outermost regions and their integration in the internal market, as recently reconfirmed in the Commission\u2019s Communication \u2018A stronger and renewed strategic partnership with the EU\u2019s outermost regions\u2019. (74) The Programme should promote synergies, while avoiding duplication with related Union programmes and actions. The actions under the Programme should be complementary to those of the Customs and Fiscalis Programmes established by Regulation (EU) 2021/444 of the European Parliament and of the Council (38) and a Regulation of the European Parliament and of the Council establishing the \u2018Fiscalis\u2019 programme for cooperation in the field of taxation respectively, which also aim towards supporting and improving the functioning of the internal market. (75) The Programme should promote synergies, complementarities and additionality with respect to the SMEs and entrepreneurship support under the European Regional Development Fund established by a Regulation of the European Parliament and of the Council on the European Regional Development Fund and on the Cohesion Fund. Moreover, the SME policy window of the InvestEU Fund will guarantee debt and equity support to enhance access and availability of finance for SMEs. The Programme should also seek synergies with the Space Programme established by Regulation (EU) 2021/696 of the European Parliament and of the Council (39) in respect of encouraging SMEs to benefit from breakthrough innovation and other solutions developed under that programme. (76) The Programme should promote synergies with Horizon Europe, which aims to promote research and innovation. This should concern in particular complementarity with the actions of the future European Innovation Council for innovative companies, as well as the support of services for SMEs, in particular via the EEN. (77) The Programme should promote synergies and complementarities with respect to the Digital Europe Programme which aims to promote the digitalisation of the Union economy and the public sector while increasing cybersecurity. (78) In addition, the Programme should also seek synergies with the Justice Programme established by Regulation (EU) 2021/693 of the European Parliament and of the Council (40) which aims to support the further development of a European area of justice for the effectiveness of national justice systems, since this is key to enabling the creation of a fair and cost effective Union economy. (79) The Programme should promote synergies with Erasmus+ programme, the European Solidarity Corps Programme established by Regulation (EU) XXXX/XXX of the European Parliament and of the Council (41) and the European Social Fund Plus established by a Regulation of the European Parliament and of the Council on the European Social Fund Plus (ESF+) in the area of labour and youth mobility, which is essential for the well-functioning internal market. (80) Finally, actions such as veterinary and phytosanitary measures in case of animal and plant health crises could be complemented by market-based interventions from the Union\u2019s Common Agriculture Policy programming. (81) The actions implemented under the Programme should represent clear Union added value and be used to address market failures, or sub-optimal investment situations in a proportionate manner, without duplicating or crowding out private financing. (82) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (42). The advisory procedure should be used for the adoption of work programmes implementing the actions contributing to the empowerment of consumers. The examination procedure should be used respectively for the adoption of implementing acts related to the actions contributing to the competitiveness of SMEs and for the adoption of implementing acts related to the work programmes implementing the actions contributing to a high level of health for humans, animals, and plants and for establishing lower co-financing rates where that is necessary for actions concerning veterinary and phytosanitary emergency measures and the annual and multiannual national veterinary and phytosanitary programmes as well as for the adoption of implementing acts related to the work programmes implementing the actions contributing to food and feed safety. (83) Where synergies between specific objectives of the Programme can be achieved, the necessary provisions could be implemented in a joint work programme. (84) The forms of Union funding and the methods of implementation of the Programme should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the Union added value, the costs of controls, the administrative burden and the expected risk of non-compliance. This should include considering the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (85) To ensure regular monitoring and reporting on the progress achieved and on the effectiveness and efficiency of the Programme, a proper framework for monitoring the actions and results of the Programme should be put in place from the very beginning. Such monitoring and reporting should be based on indicators that measure the effects of the actions under the Programme against pre-defined baselines. (86) Pursuant to paragraph 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (43), this Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Programme on the ground. The Commission should draw up an interim evaluation report on the achievement of the objectives of the actions supported under the Programme, on the results and impacts, on the efficiency of the use of resources and on its Union added value, as well as a final evaluation report on the longer impact, the results and the sustainability of the actions, and the synergies with other Programmes. (87) To monitor the support to SMEs, the Programme should use measurable performance indicators. Subject to the availability of information and where relevant, those indicators should measure results and impact achieved by the Programme in respect of its specific objectives and specific target groups (for example women, youth and seniors). In particular, when monitoring, it is important to measure the support given to the green and digital transition, internationalisation and innovation. In addition, monitoring should take into account contextual indicators, which do not measure the performance of the Programme, but which afford an overview of the environment in which SMEs operate. (88) A non-exhaustive list of animal diseases and zoonoses which qualify for funding under emergency measures and for funding under the eradication, control and surveillance programmes should be established on the basis of animal diseases referred to in Regulation (EC) No 999/2001 of the European Parliament and of the Council (44), Regulation (EC) No 2160/2003 of the European Parliament and of the Council (45), Directive 2003/99/EC of the European Parliament and of the Council (46) and Regulation (EU) 2016/429 of the European Parliament and of the Council (47). (89) In order to take account of situations that are brought about by animal diseases that have a significant impact on livestock production or trade, the development of zoonoses which pose a threat to humans, or new scientific or epidemiological developments, as well as animal diseases, which are likely to constitute a new threat for the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the list of animal diseases and zoonoses. In order to take account of future developments concerning the entities which may be awarded a grant under the Programme in relation to the representation of consumer interest at the Union level, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the list of those entities. In order to ensure effective assessment of progress of the Programme towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending, where necessary, the list of indicators used to measure the achievement of the specific objectives as well as supplementing this Regulation by establishing a monitoring and evaluation framework. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. Stakeholders and consumer associations should also be consulted. To ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (90) Pursuant to Council Decision 2013/755/EU (48), individuals and entities established in overseas countries or territories are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (91) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (49) and Council Regulations (EC, Euratom) No 2988/95 (50), (Euratom, EC) No 2185/96 (51) and (EU) 2017/1939 (52), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, OLAF has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939 to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (53). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (92) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, prizes, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (93) Regulation (EU) 2016/679 of the European Parliament and of the Council (54) governs the processing of personal data carried out in the Member States in the context of this Regulation and under the supervision of the Member States competent authorities. Regulation (EU) 2018/1725 of the European Parliament and of the Council (55) governs the processing of personal data carried out by the Commission within the framework of this Regulation and under the supervision of the European Data Protection Supervisor. Any exchange or transmission of information by competent authorities is to comply with the rules on the transfer of personal data as laid down in Regulation (EU) 2016/679, any exchange or transmission of information by the Commission is to comply with the rules on the transfer of personal data as laid down in Regulation (EU) 2018/1725. (94) Regulation (EC) No 223/2009 establishes the rules of producing statistics in accordance with the principle of statistical confidentiality and stipulates that the National Statistical Institutes, other national authorities and the Commission (Eurostat) are to take all necessary measures to ensure the alignment of principles and guidelines with regard to the physical and logical protection of confidential data. (95) Since the objective of this Regulation, namely establishing a programme for improving the functioning of the internal market, the competitiveness and sustainability of enterprises, especially SMEs, and consumer protection, for the area of plants, animals, food and feed, and for the programming and financing framework for the development, production and dissemination of European statistics for the period 2021-2027, cannot be sufficiently achieved by the Member States due to the cross-border nature of the issues involved, but can rather, by reason of the greater potential of Union action, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (96) The Programme should also ensure greater visibility and coherence of the Union\u2019s internal market, competitiveness and sustainability of enterprises, especially SMEs, and European statistics actions towards Union citizens, businesses and administrations. (97) Since amending provisions of legal acts exhaust their effects at the moment of their entry into force and the amendments they introduce in other legal acts thus become part of those legal acts at that same moment, the repeal of Regulation (EU) No 652/2014 of the European Parliament and of the Council (56) has no effect on the amendments already introduced by its amending provisions in other legal acts, and in particular in Regulation (EC) No 178/2002 of the European Parliament and of the Council (57) and Council Directive 2008/90/EC (58) with regard to the setting up of the Standing Committee on Plants, Animals, Food and Feed, which remains in force notwithstanding the repeal of Regulation (EU) No 652/2014. (98) In order to ensure continuity in the provision of support between the 2014-2020 programmes in the fields of competitiveness and sustainability of enterprises, especially SMEs, consumer protection, customers and end-users in financial services, policymaking in financial services, plants, animals, food and feed, and European statistics, established by Regulation (EU) No 1287/2013, Regulation (EU) No 254/2014 of the European Parliament and of the Council (59), Regulation (EU) 2017/826, Regulation (EU) No 258/2014 of the European Parliament and of the Council (60), Regulation (EU) No 652/2014, Regulation (EU) No 99/2013 and this Programme, in particular with regard to the continuation of multiannual measures and to the evaluation of the previous programmes\u2019 successes, and to allow implementation to start from the beginning of the multi-annual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021. As of 1 January 2028, the technical and administrative assistance appropriations should cover, if necessary, the expenditure related to the management of actions not completed by the end of the Programme. (99) Due to the delayed entry into force of this Regulation, it is not possible to respect the deadlines for the adoption of the work programmes in the plant, animal, food and feed area and for the submission by the Member States of their 2021 and 2022 veterinary and phytosanitary programmes, nor is it possible for the Commission to respect the deadlines for approving those programmes. In order to ensure the proper implementation of the actions in the plant, animal, food and feed area in 2021 and 2022, those deadlines should not apply for the years 2021 and 2022. (100) Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014 should therefore be repealed with effect from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes a programme for improving the functioning of the internal market, the competitiveness and sustainability of enterprises, especially micro, small and medium-sized enterprises, and consumer protection, for the management of expenditure in the area of plants, animals, food and feed, and for the programming and financing framework used for the development, production and dissemination of European statistics within the meaning of Article 13 of Regulation (EC) No 223/2009 (Single Market Programme) (the \u2018Programme\u2019) for the period from 1 January 2021 to 31 December 2027. The duration of the Programme is aligned to the duration of the multiannual financial framework. This Regulation also lays down the objectives of the Programme and the eligible actions for implementing those objectives, the budget for the period 2021 to 2027, the forms of Union funding and the rules for providing such funding, and the system of governance of the Programme. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018blending operation\u2019 means an action supported by the Union budget, including within a blending facility or platform as defined in Article 2(6) of the Financial Regulation, that combines non-repayable forms of support or financial instruments from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; (2) \u2018European statistics\u2019 means statistics developed, produced and disseminated in accordance with Regulation (EC) No 223/2009; (3) \u2018legal entity\u2019 means a natural person, or a legal person created and recognised as such under Union, national or international law, which has legal personality and the capacity to act in its own name, exercise rights and be subject to obligations, or an entity which does not have legal personality as referred to in Article 197(2)(c) of the Financial Regulation; (4) \u2018micro, small and medium-sized enterprises\u2019 or \u2018SMEs\u2019 means micro, small and medium-sized enterprises as defined in Recommendation 2003/361/EC; (5) \u2018clusters and business network organisations\u2019 means structures or organised groups of independent parties in the form of organisations that support the enhancement of collaboration, networking and learning of groups of enterprises that are designed to provide or channel specialised and customised business support services, especially for SMEs, in order to stimulate, inter alia, innovation and internationalisation activities, including by promoting the sharing of facilities and the exchange of knowledge and expertise. Article 3 Programme objectives 1. The general objectives of the Programme are the following: (a) to improve the functioning of the internal market, and especially to protect and empower citizens, consumers and businesses, in particular SMEs, by enforcing Union law, facilitating market access, setting standards and promoting human, animal and plant health and animal welfare, whilst respecting the principles of sustainable development and ensuring a high level of consumer protection, as well as by enhancing cooperation between the competent authorities of Member States and between the competent authorities of Member States and the Commission and the decentralised Union agencies; (b) to develop, produce and disseminate high-quality, comparable, timely and reliable European statistics which underpin the design, monitoring and evaluation of all Union policies and help citizens, policymakers, authorities, businesses, academia and the media to make informed decisions and to actively participate in the democratic process. 2. The specific objectives of the Programme are the following: (a) making the internal market more effective, inter alia, in the light of the digital transformation, by: (i) facilitating the prevention and removal of discriminatory, unjustified or disproportionate obstacles and supporting the development, implementation and enforcement of Union law in the areas of the internal market for goods and services, including by improving the application of the principle of mutual recognition, of public procurement rules, of company law, of contract and extra-contractual law, of anti-money laundering rules, of the free movement of capital and of financial services and competition rules, including by developing user-centric governance tools; (ii) supporting effective market surveillance throughout the Union, with a view to ensuring that only safe and compliant products offering a high level of protection of consumers and other end-users are made available on the Union market, including products sold online, as well as with a view to achieving greater homogeneity among, and increasing the capacity of, the market surveillance authorities across the Union; (b) strengthening the competitiveness and sustainability of SMEs and achieving additionality at Union level through measures that: (i) provide various forms of support to SMEs as well as clusters and business network organisations, including in the tourism sector, thereby fostering the growth, scale-up and creation of SMEs; (ii) facilitate access to markets including through the internationalisation of SMEs; (iii) promote entrepreneurship and the acquisition of entrepreneurial skills; (iv) promote a favourable business environment for SMEs, support the digital transformation of SMEs and promote new business opportunities for SMEs, including those that are social economy enterprises and those with innovative business models; (v) support the competitiveness of industrial ecosystems and sectors, as well as the development of industrial value chains; (vi) promote the modernisation of industry, contributing to a green, digital and resilient economy; (c) ensuring the effective functioning of the internal market through standardisation processes that: (i) enable the financing of European standardisation and the participation of all relevant stakeholders in setting up European standards; (ii) support the development of high-quality international financial and non-financial reporting and auditing standards, facilitate their integration into the Union law, and promote the innovation and development of best practices in corporate reporting; (d) promoting the interests of consumers and ensuring a high level of consumer protection and product safety by: (i) in respect of consumers: \u2014 empowering, assisting and educating consumers, businesses and representatives of civil society in particular concerning consumer\u2019s rights under Union law; \u2014 ensuring a high level of consumer protection, sustainable consumption and product safety in particular for the most vulnerable consumers in order to enhance fairness, transparency and trust in the internal market; \u2014 ensuring that the interests of consumers in the digital world are duly taken into consideration; \u2014 supporting competent enforcement authorities and consumer representative organisations and actions which enhance the cooperation between competent authorities, with particular emphasis on issues raised by existing and emerging technologies; \u2014 contributing to improving the quality and availability of standards across the Union; efficiently addressing unfair commercial practices; \u2014 ensuring that all consumers have access to efficient redress mechanisms and are provided with adequate information on markets and consumers rights, and promoting sustainable consumption, in particular through raising awareness about specific characteristics and the environmental impact of goods and services; (ii) in respect of consumers and other financial services end-users: \u2014 enhancing the participation of consumers, other financial services end-users and representatives of civil society in financial services policy-making; \u2014 promoting a better understanding of the financial sector and of the different categories of commercialised financial products; \u2014 ensuring that the interests of consumers in the area of retail financial services are protected; (e) contributing to a high level of health and safety for humans, animals and plants in plant, animal, food and feed areas, inter alia, by preventing, detecting and eradicating animal diseases and plant pests, including by means of emergency measures that are taken in the event of large-scale crisis situations and unforeseeable events affecting animal or plant health, and by supporting the improvement of the welfare of animals, the fight against antimicrobial resistance and the development of sustainable food production and consumption, as well as by stimulating the exchange of best practices between stakeholders in those fields; (f) developing, producing, disseminating and communicating high-quality European statistics in line with the quality criteria laid down in Article 12(1) of Regulation (EC) No 223/2009, in a timely, impartial and cost-efficient manner, through a strengthened European Statistical System, referred to in Article 4 of Regulation (EC) No 223/2009, and enhanced partnerships within that system and with all relevant external parties, using multiple data sources, advanced data analytics methods, smart systems and digital technologies, and providing a national and, where possible, regional breakdown. Article 4 Budget 1. The financial envelope for the implementation of the Programme for the period from 1 January 2021 to 31 December 2027 shall be EUR 4 208 041 000 in current prices. 2. Within the amount referred to in paragraph 1 the following indicative amounts shall be allocated to the following objectives: (a) EUR 451 569 500 to the objective referred to in Article 3(2)(a)(i); (b) EUR 105 461 000 to the objective referred to in Article 3(2)(a)(ii); (c) EUR 1 000 000 000 to the objective referred to in Article 3(2)(b); (d) EUR 220 510 500 to the objective referred to in Article 3(2)(c); (e) EUR 198 500 000 to the objective referred to in Article 3(2)(d); (f) EUR 1 680 000 000 to the objective referred to in Article 3(2)(e); (g) EUR 552 000 000 to the objective referred to in Article 3(2)(f). 3. The amount referred to in paragraph 1 may be used for technical and administrative assistance for the implementation of the Programme, concerning in particular preparatory, monitoring, control, audit and evaluation activities, the use of information technology networks focusing on information processing and exchange, and the use and development of corporate information technology tools. In order to ensure maximum availability of the Programme to finance actions covered by the objectives of the Programme, the total costs of administrative and technical support shall not exceed 5 % of the value of the financial envelope referred to in paragraph 1. 4. Budgetary commitments extending over more than one financial year may be broken down over several years into annual instalments. 5. By way of derogation from Article 111(2) of the Financial Regulation, the Commission shall make the budgetary commitment for the grant awarded for veterinary and phytosanitary emergency measures under the specific objective referred to in Article 3(2)(e) of this Regulation after the payment applications submitted by Member States have been assessed. 6. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme subject to the conditions set out in Article 26 of a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the \u2018Common Provisions Regulation for 2021-2027\u2019). The Commission shall implement those resources directly in accordance with Article 62(1), first subparagraph, point (a) of the Financial Regulation or indirectly in accordance with Article 62(1), first subparagraph, point (c) of that Regulation. Those resources shall be used for the benefit of the Member State concerned. 7. Where the Commission has not entered into a legal commitment under direct or indirect management for resources transferred in accordance with paragraph 6 of this Article, the corresponding uncommitted resources may be transferred back to the Fund from which they have been initially transferred, at the request of the Member State, in accordance with the conditions set out in Article 26 of the Common Provisions Regulation for 2021-2027. Article 5 Third countries associated to the Programme The Programme shall be open to the participation of the following third countries: (a) members of the European Free Trade Association which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or in similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country any decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. The contributions referred to in point (d)(ii) of the first paragraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. Article 6 Implementation and forms of Union funding 1. The Programme shall be implemented under direct management in accordance with the Financial Regulation or under indirect management with bodies referred to in Article 62(1), first subparagraph, point (c) of that Regulation. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, and in particular by way of grants, prizes and procurement. It may also provide financing in the form of financial instruments within blending operations. 3. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and shall be considered as sufficient guarantee under the Financial Regulation. The provisions laid down in Article 37(7) of Regulation (EU) 2021/695 shall apply. CHAPTER II GRANTS Article 7 Grants Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation. Article 8 Eligible actions 1. Only actions implementing the objectives referred in Article 3 shall be eligible for funding. 2. In particular, the following actions implementing the objectives referred in Article 3 shall be eligible for funding: (a) the creation of the right conditions to empower all actors of the internal market, including businesses, citizens, consumers, representatives of civil society and public authorities, through the transparent exchange of information and campaigns to raise awareness, particularly as regards applicable Union rules and the rights of businesses, citizens and consumers, as well as through the exchange and dissemination of good practices, expertise, knowledge and innovative solutions, including through actions implemented through the SOLVIT network and the European Consumer Centres Network; (b) provision of mechanisms for citizens, consumers, end-users and representatives of civil society, including representatives of the social partners and business representatives from the Union, in particular those representing SMEs, to contribute to political discussions, policies and decision making process, notably by supporting the functioning of representative organisations at national and Union level; (c) capacity building, facilitation and coordination of joint actions between Member States, between the competent authorities of Member States and between the competent authorities of Member States and the Commission, the decentralised Union agencies and third country authorities, including joint actions aimed at strengthening product safety; (d) support for the effective enforcement and modernisation of the Union legal framework and for its rapid adaptation to enable the Union to effectively face global competition, as well as support for efforts to resolve issues raised by digitalisation, including through the following: (i) data gathering and analyses; (ii) research on the functioning of the internal market, studies, evaluations and policy recommendations; (iii) the organisation of demonstration activities and pilot projects; (iv) communication activities; (v) the development of dedicated IT tools to ensure the transparent and efficient functioning of the internal market and to combat and prevent fraudulent practices on the internet. 3. Actions constituting activities referred to in Article 36 of Regulation (EU) 2019/1020 and implementing the specific objectives referred to in Article 3(2)(a)(ii) of this Regulation shall be eligible for funding, in particular in respect of the following: (a) coordination and cooperation between market surveillance authorities and other relevant Member States authorities, in particular through the Union Product Compliance Network; (b) support for the development of joint actions and testing in the field of compliance including in relation to connected products and products sold online; (c) support for market surveillance strategies, knowledge and intelligence gathering, testing capabilities and facilities, peer reviews, training programmes, technical assistance and capacity building for market surveillance authorities. 4. Actions implementing the specific objective referred to in Article 3(2)(b) shall be eligible for funding, in particular in respect of the following: (a) providing various forms of support to SMEs, including information, mentoring, training, education, mobility, cross-border cooperation or advisory services; (b) facilitating, in coordination with Member States, the access of SMEs and clusters and business network organisations to markets within and outside the Union, supporting them, during their life-cycle, in addressing global environmental, economic and societal challenges and business internationalisation, and strengthening Union entrepreneurial and industrial leadership in global value chains; (c) supporting the work of the Enterprise Europe Network (EEN) in providing integrated business support services to Union SMEs, including helping those SMEs find business partners and funding, in particular from the InvestEU, Horizon Europe and Digital Europe Programme, facilitating their innovation uptake, their internationalisation and their green and digital transition and helping them access digital, environmental, climate, energy and resource efficiency expertise, in order to make it easier for them to explore opportunities in the internal market and in third countries, whilst avoiding duplication of activities by closely coordinating with the Member States in accordance with the principle of subsidiarity and bearing in mind the need to ensure that when the EEN is being used to deliver services on behalf of other Union programmes, including advisory or capacity-building services, those services are to be funded by those other Union programmes; (d) addressing market barriers and the administrative burden and creating a favourable business environment to empower SMEs to benefit from the internal market; (e) facilitating the development and growth of businesses, including through promoting technical, digital and entrepreneurial skills, sustainable business management and product and process development in order to foster green and digital transformation across industrial ecosystems and throughout the value chains of the manufacturing and service sectors; (f) supporting the competitiveness and sustainability of enterprises and whole sectors of the economy, and supporting the uptake of creativity and all forms of innovation by SMEs, the enhancing of corporate social responsibility, the adoption of new business models and value chain collaboration, through strategically connecting ecosystems and clusters, including the Joint Cluster Initiatives; (g) fostering an entrepreneurial business environment and entrepreneurial culture, including through mentoring and mobility schemes to improve know-how, skills, technological capacity and enterprise management, as well as by supporting start-ups, business sustainability and scale-ups in particular projects, based on market-driven opportunities, paying special attention to the particular needs of potential new entrepreneurs, as well as those of the members of underrepresented groups. 5. Actions constituting activities referred to in Articles 15 and 16 of Regulation (EU) No 1025/2012 and implementing the specific objective referred to in Article 3(2)(c)(i) of this Regulation shall be eligible for funding. 6. The actions providing support for activities that aim to develop, apply, assess and monitor international standards in the fields of financial and non-financial reporting and auditing and to oversee their standard-setting processes and implementing the specific objective referred to in Article 3(2)(c)(ii) shall be eligible for funding. 7. In particular, the following actions implementing the specific objective referred in Article 3(2)(d)(i) shall be eligible for funding: (a) improving awareness, digital literacy and life-long education of consumers about their rights, including regarding issues raised by technological development and digitalisation, including addressing the particular needs of vulnerable consumers; (b) facilitating access for consumers and traders to quality out of court dispute resolution and online dispute resolution and to information on the possibilities of obtaining redress; (c) supporting stronger enforcement of consumer law by competent authorities, including in situations where traders are established in third countries, in particular through efficient cooperation and joint actions; (d) fostering sustainable consumption, in particular by raising consumer awareness of the environmental performance of products, such as their durability and eco-design features, as well as fostering the application of consumer rights and redress possibilities in relation to misleading practices. 8. The actions set out in Annex I implementing the specific objective referred to in Article 3(2)(e) shall be eligible for funding. 9. The actions set out in Annex II implementing the specific objective referred to in Article 3(2)(f) shall be eligible for funding. Article 9 Eligible entities 1. The eligibility criteria set out in paragraphs 2 to 7 of this Article shall apply in addition to the criteria set out in Article 197 of the Financial Regulation. 2. Subject to the eligibility conditions laid down in paragraphs 3 to 7, the following entities shall be eligible under the Programme: (a) legal entities established in any of the following: (i) a Member State or an overseas country or territory linked to it; or (ii) a third country associated to the Programme in accordance with Article 5; (b) legal entities created under Union law or international organisations; (c) exceptionally, legal entities established in a third country which is not associated to the Programme, provided that the participation of those legal entities in the action falls within the objectives of the Programme and the activities outside the Union contribute to the effectiveness of interventions carried out in Member State territories to which the Treaties apply. 3. Legal entities established in a third country which is not associated to the Programme may participate in the following actions: (a) actions implementing the specific objective referred to in Article 3(2)(b); (b) actions supporting consumer protection implementing the specific objective referred to in Article 3(2)(d)(i). The entities participating in the actions referred to in the first subparagraph shall not be entitled to receive Union financial contributions, except where their participation is essential for the Programme, in particular in terms of improving competitiveness and access to markets for Union enterprises or in terms of protecting consumers residing in the Union. That exception shall not apply to profit-making entities. 4. For actions implementing the specific objective referred to in Article 3(2)(c)(i) of this Regulation, the entities referred to in Articles 15 and 16 of Regulation (EU) No 1025/2012 shall be eligible. 5. Each Member State and each third country which is a member of the EEA shall designate, as the result of a transparent procedure, an entity as eligible for actions that support consumer protection by implementing the specific objective referred to in Article 3(2)(d)(i) and that are related to the European Consumer Centres Network. That entity may be: (a) a non-profit-making body; (b) a public body. 6. Third countries shall be eligible for the following actions implementing the specific objective referred to in Article 3(2)(e): (a) protection measures taken in the case of a direct threat to the status of health in the Union as a result of the occurrence or development, in the territory of a third country or a Member State, of one of the animal diseases and zoonoses listed in Annex III or plant pests listed in the work programme referred to in Article 16; (b) protection measures or other relevant activities, taken in support of the health status of plants in the Union. The Commission is empowered to adopt delegated acts in accordance with Article 20 to amend Annex III where that is necessary in order to take account of the occurrence of new animal diseases and zoonoses which are not covered by Union legal acts referred to in that Annex. Except in the case of animal diseases and plant pests that have a substantial impact on the Union, in principle, third countries that are not associated to the Programme should finance their own participation in the actions referred to in the first subparagraph. 7. For actions implementing the specific objective referred to in Article 3(2)(f), the following legal entities shall be eligible: (a) national statistical institutes and other national authorities as referred to in Article 5(2) of Regulation (EC) No 223/2009; (b) for actions supporting collaborative networks, as referred to in Article 15 of Regulation (EC) No 223/2009, bodies operating in the field of statistics other than the authorities referred to in point (a) of this paragraph; (c) non-profit making entities, which are independent of industry, commercial and business or other conflicting interests, and have as their primary objectives and activities the promotion and support of the implementation of the European statistics Code of Practice referred to in Article 11 of Regulation (EC) No 223/2009 or the implementation of new methods of production of European statistics aiming at efficiency gains and quality improvements at Union level. Article 10 Designated beneficiaries 1. The following entities may be awarded a grant under the Programme without a call for proposals: (a) for actions in the area of accreditation implementing the specific objective referred to in Article 3(2)(a)(i) of this Regulation, the body recognised under Article 14 of Regulation (EC) No 765/2008 to carry out the activities referred to in Article 32 of Regulation (EC) No 765/2008; (b) for actions in the area of market surveillance implementing the specific objective referred to in Article 3(2)(a)(ii) of this Regulation, the market surveillance authorities of the Member States referred to in Article 17 of Regulation (EC) No 765/2008 and Article 10 of Regulation (EU) 2019/1020; (c) for actions implementing the specific objective referred to in Article 3(2)(c)(i) of this Regulation, the entities referred to in Articles 15 and 16 of Regulation (EU) No 1025/2012; (d) for actions implementing the specific objective referred to in Article 3(2)(c)(ii), the European Financial Reporting Advisory Group (EFRAG), the International Financial Reporting Standards Foundation and the Public Interest Oversight Board (PIOB); (e) for actions implementing the specific objective referred to in Article 3(2)(d)(i) that relate to the representation of consumers interests at Union level, the Bureau Europ\u00e9en des Unions de Consommateurs (BEUC) and the European Association for the Coordination of Consumer Representation in Standardisation (ANEC) provided that they have no conflicts of interests and that each of them represents, through its members, the interests of Union consumers in at least two thirds of the Member States; (f) for actions implementing the specific objective referred to in Article 3(2)(d)(ii), Finance Watch and Better Finance subject to the following conditions, which are to be assessed annually: (i) the entities remain non-governmental, non-profit and independent of industry, commerce or business; (ii) they have no conflicting interests and represent through their members the interests of Union consumers and other end-users in the financial services area; (g) for actions implementing the specific objective referred to in Article 3(2)(e) of this Regulation: (i) the competent authorities of the Member States and their affiliated entities, the European Union reference laboratories referred to in Article 92 of Regulation (EU) 2017/625, the European Union reference centres referred to in Articles 95 and 97 of Regulation (EU) 2017/625 and in Article 29 of Regulation (EU) 2016/1012 of the European Parliament and of the Council (61), and the relevant international organisations, as well as the national plant health reference laboratories and the national animal health reference laboratories, without prejudice to the obligation for Member States to provide adequate financial resources for those national reference laboratories in accordance with Regulation (EU) 2017/625 and on condition that the actions supporting the performance by those national reference laboratories of the official controls and other official activities within the meaning of Article 2 of Regulation (EU) 2017/625 can be clearly shown to represent Union added value, and that sufficient funding is available under the Programme to support those actions; (ii) in the case of actions described under Article 9(6)(a) and (b) of this Regulation, the competent authorities of third countries; (h) for actions implementing the specific objective referred to in Article 3(2)(f) of this Regulation, the national statistical institutes and other national authorities referred to in Article 5(2) of Regulation (EC) No 223/2009. 2. The Commission is empowered to adopt delegated acts in accordance with Article 20 to amend paragraph 1(e) of this Article with regard to the entities which may be awarded a grant under the Programme. Article 11 Evaluation of the proposal and award criteria 1. The work of the evaluation committees shall be based on the general principles applicable to grants laid down in Article 188 of the Financial Regulation and in particular, on the principles of equal treatment and transparency, as well as on the principle of non-discrimination. 2. The evaluation committees shall evaluate proposals on the basis of award criteria, such as the relevance of the proposed actions in view of the objectives pursued, quality of the proposed actions, impact, including economic, social and environmental impact, budget and cost-effectiveness. Article 12 Co-financing rules 1. For actions implementing the specific objective referred to in Article 3(2)(a)(ii) of this Regulation with reference to market surveillance authorities of the Member States and of the third countries associated to the Programme and with reference to Union testing facilities as referred to in Article 21 of Regulation (EU) 2019/1020, the Programme may, by way of derogation from Article 190 of the Financial Regulation, finance up to 100 % of eligible costs of an action. 2. For grants for financial support actions in the context of the specific objective referred to in Article 3(2)(b) of this Regulation, the Programme may, by way of derogation from Article 190 of the Financial Regulation, finance up to 100 % of the eligible costs for financial support to third parties and up to 90 % of the eligible costs for the other cost categories. For EEN actions in the context of the specific objective referred to in Article 3(2)(b) of this Regulation, the Programme may, by way of derogation from Article 190 of the Financial Regulation, finance up to 100 % of the eligible costs for additional coordination and networking costs and up to 60 % of the eligible costs for the other cost categories. Moreover, eligible indirect costs shall be determined by applying a flat rate of 25 % of the total direct eligible costs, excluding direct eligible costs for subcontracting, financial support to third parties and any unit costs or lump sums which include indirect costs. 3. For grants awarded to the PIOB implementing the specific objective referred to in Article 3(2)(c)(ii), if funding by the International Federation of Accountants (IFAC) in a given year reaches more than two-thirds of the total annual funding, the annual contribution for that year shall be limited to a maximum amount specified in the work programme referred to in Article 16(1). 4. For grants awarded to ANEC under Article 10(1)(e), the Programme may finance up to 95 % of the eligible costs. 5. For actions implementing the specific objective referred to in Article 3(2)(e) of this Regulation, the Programme may, by way of derogation from Article 190 of the Financial Regulation, finance up to 100 % of the eligible costs. For the actions referred to in Annex I, points 1 and 2, the co-financing rate applied shall be 50 % of the eligible costs, with the following exceptions: (a) The rate shall be 75 % of the eligible costs, in respect of: (i) cross-border activities implemented together by two or more Member States in order to control, prevent or eradicate plant pests or animal diseases; (ii) Member States of which the gross national income per inhabitant based on the latest Eurostat data is less than 90 % of the Union average. (b) By way of derogation from Article 190 of the Financial Regulation, the rate shall be 100 % of the eligible costs, where the activities benefitting from the Union contribution concern the prevention and control of serious human, plant and animal health risks for the Union, and: (i) are designed to avoid human casualties or major economic disruptions for the Union as a whole; (ii) constitute specific tasks which are indispensable for the Union as a whole as laid down by the Commission in the work programme referred to in Article 16(4); or (iii) are implemented in third countries. (c) Where necessary on the grounds of lack of funds, insufficient implementation of the Programme or the emergency measure, or the phasing-out of the co-financing of actions against animal diseases or plant pests the co-financing rates shall be lower. For the purposes of point (c) of the second subparagraph of this paragraph, the amount of the reduction in the co-financing rates shall reflect the significance of the grounds for a lower rate. The Commission shall adopt implementing acts establishing lower co-financing rates. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(6). 6. For actions implementing the specific objective referred to in Article 3(2)(f) of this Regulation, the Programme may finance up to 95 % of the eligible costs of actions supporting collaborative networks as referred to in Article 15 of Regulation (EC) No 223/2009. Article 13 Eligible costs related to programmes and emergency measures 1. In addition to the eligible costs criteria set out in Article 186 of the Financial Regulation, the costs incurred by the Member States for implementing the emergency measures referred to in Annex I, points 1.4.1 and 1.4.2 implementing the specific objective referred to in Article 3(2)(e) of this Regulation: (a) shall be eligible prior to the date of submission of the grant application in accordance with Article 193(2), second subparagraph, point (b) of the Financial Regulation; (b) shall be eligible from the date of the suspected occurrence of an animal disease or the presence of a plant pest, provided that that occurrence or presence is subsequently confirmed. The submission of the grant application shall be preceded by the notification to the Commission of the occurrence of the animal disease in accordance with Article 19 or 20 and rules adopted on the basis of Article 23 of Regulation (EU) 2016/429, or the presence of the Union quarantine pest in accordance with Article 9, 10 or 11 of Regulation (EU) 2016/2031 of the European Parliament and of the Council (62). 2. For actions implementing the specific objective referred to in Article 3(2)(e) of this Regulation, eligible costs referred to in Annex I, points 2.2.1 and 2.2.2 as regards the execution of the programmes may qualify for grants, if they fulfil the criteria set out in Article 186 of the Financial Regulation. Article 14 Cumulative and alternative financing 1. An action that has received a contribution from another Union programme may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 2. Actions that have been attributed a Seal of Excellence label under this Programme may receive support from the European Regional Development Fund or the European Social Fund Plus, in accordance with Article 73(4) of the Common Provisions Regulation for 2021-2027 if they comply with the following cumulative conditions: (a) they have been assessed in a call for proposals under the Programme; (b) they comply with the minimum quality requirements of that call for proposals; (c) it is not possible for them to be financed under that call for proposals due to budgetary constraints. 3. An operation may receive support from one or more Union programmes. When this occurs, expenditure declared in a payment application shall not be declared in a payment application for another programme. 4. The amount of expenditure to be entered into a payment application may be calculated for each programme concerned on a pro rata basis, in accordance with the document setting out the conditions for support. CHAPTER III BLENDING OPERATIONS Article 15 Blending operations Blending operations decided under the Programme shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. CHAPTER IV IMPLEMENTATION, MONITORING AND CONTROL Article 16 Implementation of the Programme 1. The Programme shall be implemented by work programmes referred to in Article 110(2) of the Financial Regulation. The work programmes shall implement the specific objectives set out in Article 3 and the eligible actions set out in Article 8. Those work programmes shall set out in detail: (a) the indicative amount allocated to each action and, where relevant, the indicative total amount for all actions, as well as an indicative implementation timetable; (b) the essential evaluation criteria for grants, in accordance with Article 11, and the maximum co-financing rate, in accordance with Article 12. Work programmes shall set out, where applicable, the overall amount reserved for blending operations. 2. Work programmes implementing the specific objective referred to in Article 3(2)(b) shall be adopted by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(5). 3. Work programmes implementing the specific objective referred to in Article 3(2)(d)(i) shall be adopted by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 21(4). 4. Work programmes implementing the specific objective referred to in Article 3(2)(e) through actions as set out in Article 8(8) and Annex I shall be adopted by the Commission by means of implementing acts by 30 April of the year preceding their execution, provided that the draft budget is adopted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(6). 5. Actions set out in Annex II to this Regulation implementing the specific objective referred to in Article 3(2)(f) of this Regulation shall be implemented in accordance with Articles 13, 14 and 17 of Regulation (EC) No 223/2009, including initiatives regarding the review of priorities, and through close and coordinated cooperation within the European Statistical System. Article 17 Monitoring and reporting 1. Indicators to report on the progress of the Programme towards the achievement of the specific objectives laid down in Article 3(2) are set out in Annex IV. 2. When reporting on the progress of the implementation of the specific objective referred to in Article 3(2)(b), the Commission shall present relevant contextual indicators, extracted from the SME performance review, from the Small Business Act factsheets and from any other relevant source, together with the indicators referred to in paragraph 1. 3. To ensure the effective assessment of the Programme\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 20, to amend Annex IV with regard to the indicators, where considered necessary, as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 4. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where appropriate, on Member States. Article 18 Evaluation 1. Evaluations shall be carried out in a timely manner so that they can be used in the decision-making process. 2. The interim evaluation of the Programme shall be performed by four years after the start of the implementation of the Programme. The Commission shall draw up an interim evaluation report to assess the performance of the Programme, including aspects such as effectiveness, efficiency, coherence, relevance, synergies within the Programme and Union added value. 3. In relation to actions implementing the specific objective referred to in Article 3(2)(c)(ii), the Commission shall prepare an annual report on the activity of the International Financial Reporting Standards Foundation as regards the development of International Financial Reporting Standards, as well as, in general, of the PIOB and of the EFRAG. The Commission shall transmit the report to the European Parliament and to the Council. 4. At the end of the implementation of the Programme and in any event four years after the end of the period specified in Article 1 the Commission shall draw up a final evaluation report to assess the performance of the Programme, including aspects such as effectiveness, efficiency, coherence, relevance, synergies within the Programme and Union added value. 5. The Commission shall submit the interim and final evaluation reports, along with its conclusions and recommendations to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions and make them publicly available. Where appropriate, the reports shall be accompanied by proposals for follow-up actions. 6. In accordance with Article 13(5) of Regulation (EC) No 223/2009, the Commission shall consult the European Statistical System Committee for those parts of the interim and final evaluation reports that pertain to actions implementing the specific objective referred to in Article 3(2)(f) of this Regulation, prior to their adoption and submission to the European Parliament and the Council. The Commission shall consult the European Statistical Advisory Committee for the part of the final evaluation report that pertains to actions implementing the specific objective referred to in Article 3(2)(f) of this Regulation, prior to its adoption and submission to the European Parliament and the Council. Article 19 Protection of the financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, the European Anti-Fraud Office (OLAF) and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 20 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 9(6), second subparagraph, Article 10(2) and Article 17(3) shall be conferred on the Commission for a period of 7 years from 1 January 2021. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the 7-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 9(6), second subparagraph, Article 10(2) and Article 17(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 9(6), second subparagraph, Article 10(2) and Article 17(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 21 Committee procedure 1. With regard to implementing acts referred to in Article 16(2) of this Regulation, which concern the specific objective referred to in Article 3(2)(b) of this Regulation, the Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. With regard to implementing acts referred to in Article 16(3) of this Regulation, which concern the specific objective referred to in Article 3(2)(d)(i) of this Regulation, the Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 3. With regard to implementing acts referred to in Article 12(5), second subparagraph and in Article 16(4) of this Regulation, which concern the specific objective referred to in Article 3(2)(e) of this Regulation, the Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 4. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 5. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 6. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so requests. CHAPTER V TRANSITIONAL AND FINAL PROVISIONS Article 22 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions in a user-friendly manner, in order to raise awareness among consumers, citizens, businesses, especially SMEs and public administrations about the financial resources provided through the Programme, and about the actions and results thereunder. 3. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. 4. The Commission (Eurostat) shall implement information and communication actions relating to the implementation of the specific objective referred to in Article 3(2)(f) of this Regulation, including actions and results that pertain to the development, production and dissemination of European statistics, in compliance with the statistical principles laid down in Regulation (EC) No 223/2009. Article 23 Repeal Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014, and (EU) No 652/2014 are repealed with effect from 1 January 2021. Article 24 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014, (EU) No 258/2014, (EU) No 652/2014 and (EU) 2017/826, which shall continue to apply to those actions until their closure. 2. The financial envelope for the Programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted under predecessor programmes pursuant to acts listed in paragraph 1. 3. If necessary, appropriations may be entered in the budget beyond 2027 to cover the expenses provided for in Article 4(3), to enable the management of actions not completed by 31 December 2027. 4. In accordance with Article 193(2), second subparagraph, point (a) of the Financial Regulation, costs incurred before the date of submission of the grant application in respect of actions which have already begun may be considered eligible where it is necessary to ensure continuity during a limited period. By derogation from Article 193(4) of the Financial Regulation, the costs incurred prior to the date of submission of the grant application shall be eligible in the case of operating grants, where it is necessary to ensure continuity during the period from 1 January 2021 to the entry into force of this Programme. 5. The deadlines set in Article 16(4) and in point 2.1 of Annex I shall not apply in relation to programmes covering the years 2021 and 2022. Article 25 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 28 April 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 62, 15.2.2019, p. 40. (2) OJ C 86, 7.3.2019, p. 259. (3) Position of the European Parliament of 12 February 2019 (not yet published in the Official Journal) and position of the Council at first reading of 13 April 2021 (not yet published in the Official Journal). Position of the European Parliament of 27 April 2021 (not yet published in the Official Journal). (4) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (5) Regulation (EU) No 99/2013 of the European Parliament and of the Council of 15 January 2013 on the European statistical programme 2013-17 (OJ L 39, 9.2.2013, p. 12). (6) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (7) Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1). (8) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). (9) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (10) Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (OJ L 94, 28.3.2014, p. 1). (11) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (12) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (13) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (14) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (15) Regulation (EU) No 1287/2013 of the European Parliament and of the Council of 11 December 2013 establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (COSME) (2014 \u2013 2020) and repealing Decision No 1639/2006/EC (OJ L 347, 20.12.2013, p. 33). (16) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L \u2026, 12.5.2021). (17) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L \u2026, 11.5.2021). (18) Regulation (EU) XXXX/XXX of the European Parliament and of the Council of XXX establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 (not yet published in the Official Journal). (19) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 \u2013 the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104). (20) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (21) Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (OJ L 243, 11.9.2002, p. 1). (22) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19). (23) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87). (24) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). (25) Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36). (26) Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ L 80, 18.3.1998, p. 27). (27) Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (\u2018Unfair Commercial Practices Directive\u2019) (OJ L 149, 11.6.2005, p. 22). (28) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (29) Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 November 2019 amending Council Directive 93/13/EEC and Directives 98/6/EC, 2005/29/EC and 2011/83/EU of the European Parliament and of the Council as regards the better enforcement and modernisation of Union consumer protection rules (OJ L 328, 18.12.2019, p. 7). (30) Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1). (31) Regulation (EU) 2017/826 of the European Parliament and of the Council of 17 May 2017 on establishing a Union programme to support specific activities enhancing the involvement of consumers and other financial services end-users in Union policy-making in the area of financial services for the period of 2017-2020 (OJ L 129, 19.5.2017, p. 17). (32) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (33) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1). (34) Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13). (35) OJ L 433 I, 22.12.2020, p. 28. (36) OJ L 1, 3.1.1994, p. 3. (37) OJ L 90, 28.3.2006, p. 2. (38) Regulation (EU) 2021/444 of the European Parliament and of the Council of 11 March 2021 establishing the Customs programme for cooperation in the field of customs and repealing Regulation (EU) No 1294/2013 (OJ L 87, 15.3.2021, p. 1). (39) Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013, (EU) No 377/2014 and Decision No 541/2014/EU (OJ L \u2026, 12.5.2021). (40) Regulation (EU) 2021/693 of the European Parliament and of the Council of 28 April 2021 establishing the Justice Programme and repealing Regulation (EU) No 1382/2013 (OJ L \u2026, 5.5.2021). (41) Regulation (EU) XXXX/XXX of the European Parliament and of the Council of XXX establishing the European Solidarity Corps Programme and repealing Regulations (EU) 2018/1475 and (EU) No 375/2014 (not yet published in the Official Journal). (42) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (43) OJ L 123, 12.5.2016, p. 1. (44) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1). (45) Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of Salmonella and other specified food-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1). (46) Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31). (47) Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (\u2018Animal Health Law\u2019) (OJ L 84, 31.3.2016, p. 1). (48) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (Overseas Association Decision) (OJ L 344, 19.12.2013, p. 1). (49) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (50) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (51) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (52) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (53) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (54) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (55) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (56) Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC (OJ L 189, 27.6.2014, p. 1). (57) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (58) Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (Recast version) (OJ L 267, 8.10.2008, p. 8). (59) Regulation (EU) No 254/2014 of the European Parliament and of the Council of 26 February 2014 on a multiannual consumer programme for the years 2014-20 and repealing Decision No 1926/2006/EC (OJ L 84, 20.3.2014, p. 42). (60) Regulation (EU) No 258/2014 of the European Parliament and of the Council of 3 April 2014 establishing a Union programme to support specific activities in the field of financial reporting and auditing for the period of 2014-20 and repealing Decision No 716/2009/EC (OJ L 105, 8.4.2014, p. 1). (61) Regulation (EU) 2016/1012 of the European Parliament and of the Council of 8 June 2016 on zootechnical and genealogical conditions for the breeding, trade in and entry into the Union of purebred breeding animals, hybrid breeding pigs and the germinal products thereof and amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC and 90/425/EEC and repealing certain acts in the area of animal breeding (\u2018Animal Breeding Regulation\u2019) (OJ L 171, 29.6.2016, p. 66). (62) Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4). ANNEX I ELIGIBLE ACTIONS IMPLEMENTING THE SPECIFIC OBJECTIVE REFERRED TO IN ARTICLE 3(2)(E) RELATED TO THE PLANT, ANIMAL, FOOD AND FEED AREAS The following actions implementing the specific objective referred to in Article 3(2)(e) shall be eligible for funding: 1. Implementation of veterinary and phytosanitary emergency measures. 1.1. Veterinary and phytosanitary emergency measures to be taken as a result of the official confirmation of the occurrence of one of the animal diseases or zoonoses listed in Annex III or of the official confirmation of the presence of plant pests or if there is a direct threat to the human, animal or plant health status of the Union. The measures referred to in the first paragraph shall be implemented immediately and their application shall comply with the provisions laid down in relevant Union law. 1.2. As regards phytosanitary emergencies, the following measures taken by Member States against an outbreak of pests in a particular area: (a) eradication and prevention measures against a Union quarantine pest, taken by the competent authority of a Member State pursuant to Article 17 of Regulation (EU) 2016/2031 or pursuant to the Union measures adopted in accordance with Article 28(1) or (3) of that Regulation; (b) eradication and prevention measures taken by the competent authority of a Member State pursuant to Article 29(1) or 30(4) of Regulation (EU) 2016/2031 against a pest not listed as a Union quarantine pest but which may qualify as a Union quarantine pest in accordance with the criteria referred to in that Regulation; (c) additional protective measures taken against the spread of a pest, against which Union measures have been adopted in accordance with Article 28(1) and Article 30(1) of Regulation (EU) 2016/2031, other than the eradication and prevention measures referred to in points (a) and (b) of this point, where those measures are essential to protect the Union against further spread of that pest. 1.3. Union funding may also be provided for the following measures: 1.3.1. Protection or prevention measures taken in the case of a direct threat to the health status of the Union as a result of the occurrence or development, in the territory of a third country, a Member State or an overseas country or territory, of one of the animal diseases or zoonoses listed in Annex III as well as protection measures or other relevant activities, taken in support of the plant health status of the Union; 1.3.2. Measures referred to in this Annex carried out by two or more Member States which collaborate closely to control an animal disease or plant pest outbreak; 1.3.3. The establishment of stocks of biological products intended for the control of the animal diseases and zoonoses listed in Annex III, where the Commission, at the request of a Member State, considers establishment of such stocks necessary in that Member State; 1.3.4. The establishment of stocks of biological products or the acquisition of vaccine doses if the occurrence or the development in a third country or Member State of one of the animal diseases or zoonoses listed in Annex III might constitute a threat to the Union. 1.3.5. In the event of a suspected outbreak of an animal disease or the appearance of plant pests, intensified checks and monitoring within the Union and at its external borders, where needed. 1.3.6. Measures to monitor the appearance of known as well as emerging, previously unknown animal diseases and plant pests. 1.4. Eligible costs 1.4.1. Veterinary emergency measures The following costs incurred by the Member States in carrying out the veterinary emergency measures may qualify for funding: (a) costs of compensation to owners for the value of their animals slaughtered or culled, limited to the market value that such animals would have had if they had not been affected by the disease; (b) costs of slaughtering or culling the animals and related transport costs; (c) costs of compensation to owners for the value of their destroyed products of animal origin, limited to the market value of those products immediately before any suspicion of the disease arose or was confirmed; (d) costs of cleaning, desinsectisation and disinfection of holdings and equipment, based on the epidemiology and characteristics of the pathogen; (e) costs for the transport and the destruction of the contaminated feeding stuffs and, where it can not be disinfected, contaminated equipment; (f) costs of purchase, storage, administration or distribution of vaccines and baits as well as the costs of inoculation itself, if the Commission decides or authorises such actions; (g) costs of transport and disposal of carcasses; (h) in exceptional and duly justified cases, costs of serological and virological tests for surveillance and pre-moving tests in restricted zones and any other costs essential for the eradication of the disease. 1.4.2. Phytosanitary emergency measures The following costs incurred by Member States in carrying out the emergency measures in the plant health field may qualify for grants: (a) costs of personnel, regardless of their status, directly involved in the measures, as well as costs of renting equipment, of consumables and of any other necessary materials, of treatment products, of sampling and of laboratory tests; (b) costs of service contracts with third parties to execute part of the measures; (c) costs of compensating the operators or owners concerned for the treatment, the destruction and subsequent removal of plants, of plant products and of other objects, and for the cleaning and disinfection of premises, land, water, soil, growing media, facilities, machinery and equipment; (d) costs of compensating the owners concerned for the value of the destroyed plants, plant products or other objects subject to the measures referred to in Articles 17, 28(1), 29(1) and 30(1) of Regulation (EU) 2016/2031, limited to the market value that such plants, plant products and other objects would have had if they had not been affected by those measures; the salvage value, if any, shall be deducted from the compensation; and (e) in exceptional and duly justified cases, the costs incurred in carrying out necessary measures other than those referred to in points (a) to (d). The compensation to operators or owners referred to in point (c) shall only be eligible if the measures have been carried out under the supervision of the competent authority. 2. Implementation of annual and multiannual national veterinary and phytosanitary programmes 2.1. Annual and multiannual national veterinary and phytosanitary programmes for the eradication, control and surveillance of animal diseases and zoonoses listed in Annex III and of plant pests have to be implemented in compliance with the provisions laid down in the relevant Union law. The conditions for the actions to qualify for funding shall be set out in the work programme referred to in Article 16. National programmes shall be submitted to the Commission by 31 May of the year preceding the planned implementation period. The Commission shall communicate to Member States by 30 November each year: (a) the list of national programmes technically approved and proposed for co-financing; (b) the provisional amount allocated to each programme; (c) the provisional maximum level of the Union financial contribution for each programme; and (d) any provisional conditions to which the Union financial contribution may be subject. The Commission shall approve the national programmes and the associated funding by 31 January each year by means of a grant agreement in relation to the measures implemented and the costs incurred. Following the submission of intermediate financial reports by the beneficiaries by 31 August of the implementing year, the Commission may, if necessary, amend the grant agreements in relation to the whole eligibility period. 2.2. Eligible costs 2.2.1. The following costs incurred by the Member States in implementing the national veterinary programmes may qualify for Union co-financing: (a) costs of sampling animals; (b) costs of tests, provided that they are limited to: (i) costs of test kits, reagents and consumables which are identifiable and specifically used for carrying out those tests; (ii) costs of personnel, regardless of their status, directly involved in carrying out the tests; (c) costs of compensation to owners for the value of their animals slaughtered or culled, limited to the market value that such animals would have had if they had not been affected by the disease; (d) costs of slaughtering or culling of the animals; (e) costs of compensation to owners for the value of their destroyed products of animal origin, limited to the market value of those products immediately before any suspicion of the disease arose or was confirmed; (f) costs of purchase, storage, inoculation, administration or distribution of vaccine doses or vaccine and baits used for the programmes; (g) costs of cleaning, disinfection, desinsectisation of the holding and equipment based on the epidemiology and characteristics of the pathogen; and (h) in exceptional and duly justified cases, the costs incurred in carrying out necessary measures other than those referred to in points (a) to (g). For the purposes of point (c), the salvage value of the animals, if any, shall be deducted from the compensation. For the purposes of point (d), the salvage value of heat-treated non-incubated eggs shall be deducted from the compensation. 2.2.2. The following costs incurred by the Member States in implementing the national phytosanitary programmes may qualify for Union co-financing: (a) costs for sampling; (b) costs for visual examinations; (c) costs of tests, provided that they are limited to: (i) the costs of test kits, reagents and consumables which are identifiable and specifically used for carrying out the tests; (ii) the costs of personnel, regardless of their status, directly involved in carrying out the tests; (d) costs of personnel, regardless of their status, directly involved in the measures, as well as costs of renting equipment, of consumables and of any other necessary materials, of treatment products, of sampling and of laboratory tests; (e) costs of service contracts with third parties to execute part of the measures; (f) costs of compensating the operators or owners concerned for the treatment, the destruction and subsequent removal of plants, of plant products and of other objects, and for the cleaning and disinfection of premises, land, water, soil, growing media, facilities, machinery and equipment; (g) costs of compensating the owners concerned for the value of the destroyed plants, plant products or other objects subject to the measures referred to in Articles 17, 28(1), 29(1) and 30(1) of Regulation (EU) 2016/2031, limited to the market value that such plants, plant products and other objects would have had if they had not been affected by those measures; the salvage value, if any, shall be deducted from the compensation; and (h) in exceptional and duly justified cases, the costs incurred in carrying out necessary measures other than those referred to in points (a) to (g). The compensation to operators and owners referred to in point (f) shall only be eligible if the measures have been carried out under the supervision of the competent authority. 2.3. If the occurrence or the development of one of the animal diseases or zoonoses listed in Annex III is likely to constitute a threat to the health status of the Union and in order to protect the Union from the introduction of one of those diseases or zoonoses or if protection measures are necessary in support of the plant health status of the Union, Member States may include in their national programmes measures that are to be implemented in territories of third countries in cooperation with the authorities of those countries. Alternatively, Union funding may under the same circumstances and for the same objective be directly awarded to third countries\u2019 competent authorities. 2.4. As regards phytosanitary programmes, Union funding may be awarded to Member States for the following measures: (a) surveys, over specific periods of time, checking at least for the presence of: \u2014 any Union quarantine pest, and signs or symptoms of any pest subject to the measures referred to in Article 29 of Regulation (EU) 2016/2031 or to measures adopted pursuant to Article 30(1) of that Regulation, pursuant to Article 22(1) of that Regulation or, where applicable, pursuant to Articles 47 to 77 of Regulation (EU) 2017/625; \u2014 priority pests pursuant to Article 24(1) of Regulation (EU) 2016/2031; (b) surveys, over specific periods of time, checking at least for the presence of any pests, other than the pests referred to in point (a), which might represent an emerging risk for the Union, and of which the entry or spread might have a significant impact on Union territory; (c) eradication and prevention measures against a Union quarantine pest, taken by the competent authority of a Member State pursuant to Article 17 of Regulation (EU) 2016/2031 or pursuant to the Union measures adopted in accordance with Article 28(1) or (3) of that Regulation; (d) eradication and prevention measures taken by the competent authority of a Member State pursuant to Article 29(1) of Regulation (EU) 2016/2031 against a pest, not listed as a Union quarantine pest, which may qualify as a Union quarantine pest in accordance with the criteria referred to in that Regulation; (e) additional protective measures taken against the spread of a pest, against which Union measures have been adopted pursuant to Articles 28(1) and 30(1) of Regulation (EU) 2016/2031, other than the eradication and prevention measures referred to in points (c) and (d) of this point and the containment measures referred to in point (f) of this point, where those measures are essential to protect the Union against further spread of that pest; (f) measures to contain a pest, against which Union containment measures have been adopted pursuant to Article 28(2) of Regulation (EU) 2016/2031 or Article 30(3) of that Regulation, in an infested area from which that pest cannot be eradicated, where those measures are essential to protect the Union against further spread of that pest. The work programmes referred to in Article 16(4) shall determine the list of plant pests to be covered under these measures. 3. Implementation of phytosanitary programmes for the control of pests in the outermost regions of the Union referred to in Article 355(1) TFEU which are excluded from the territorial scope of Regulation (EU) 2016/2031, in line with the objectives set out in Article 24 of Regulation (EU) No 228/2013 of the European Parliament and of the Council (1). Those programmes shall concern activities necessary to ensure the correct implementation in those regions of the rules in force there on the control of pests, whether they are Union rules or national rules. 4. Activities to support the improvement of the welfare of animals, including measures to ensure compliance with animal welfare standards and traceability including during animal transport. 5. Support for European Union reference laboratories, referred to in Article 92 of Regulation (EU) 2017/625, and the European Union reference centres referred to in Articles 95 and 97 of Regulation (EU) 2017/625 and in Article 29 of Regulation (EU) 2016/1012. 6. During a period of up to three years after the designation of the European Union reference laboratory of the specific area, where appropriate and in line with Article 10(1), obtaining accreditation regarding test and diagnostic methods at national plant health reference laboratories and national animal health reference laboratories. 7. Implementation of coordinated control programmes and organisation of information and data collection, referred to in Article 112 of Regulation (EU) 2017/625. 8. Activities for preventing food waste and combating food fraud. 9. Activities supporting sustainable food production and consumption, including short supply chains. 10. Development of data-bases and computerised information management systems necessary for the effective and efficient implementation of the legislation related to the specific objective referred to in Article 3(2)(e) and having a proven added value for the Union as a whole; as well as implementation of new technologies to improve traceability of products. 11. Training of the staff of the competent authorities responsible for official controls and other parties involved in the management or prevention of animal diseases or plant pests, as referred to in Article 130 of Regulation (EU) 2017/625. 12. Payment of travel, accommodation and daily subsistence expenses incurred by Member States\u2019 experts as a result of the Commission appointing them to assist its experts as provided for in Articles 116(4) and 120(4) of Regulation (EU) 2017/625. 13. Performance of technical and scientific work necessary to ensure the correct implementation of the legislation in the area related to the specific objective referred to in Article 3(2)(e) and the adaptation of that legislation to scientific, technological and societal developments, including studies and coordination activities necessary for the prevention of the appearance of emerging plant pests and animal diseases. 14. Activities carried out by the Member States or international organisations with the aim of achieving the specific objective referred to in Article 3(2)(e) in support of the development and implementation of the rules related to that objective. 15. Performance of projects organised by one or more Member States with the aim of improving, through the use of innovative techniques and protocols, the efficient implementation of the specific objective referred to in Article 3(2)(e). 16. Implementation of information and awareness raising initiatives by the Union and Member States with the aim of ensuring improved, compliant and sustainable food production and consumption, including food waste prevention contributing to the circular economy and food fraud prevention activities, as well as other initiatives contributing to a high level of health for plants and animals, and food and feed safety, as part of the implementation of the rules in the area of the specific objective referred to in Article 3(2)(e). 17. Implementation of measures to protect human, animal and plant health and animal welfare, in respect of animals, animal products, plants, plant products and other relevant objects arriving from third countries at a Union border. (1) Regulation (EU) No 228/2013 of the European Parliament and of the Council of 13 March 2013 laying down specific measures for agriculture in the outermost regions of the Union and repealing Council Regulation (EC) No 247/2006 (OJ L 78, 20.3.2013, p. 23). ANNEX II ELIGIBLE ACTIONS IMPLEMENTING THE SPECIFIC OBJECTIVE REFERRED TO IN ARTICLE 3(2)(f) ON EUROPEAN STATISTICS The implementation of Union policies requires high-quality, comparable and reliable statistical information about the economic, social, territorial and environmental situation in the Union. Additionally, European statistics enable European citizens to understand and to participate in the democratic process and debate about the present state and future of the Union. Together with Regulation (EC) No 223/2009, and especially with reference to the professional independence of statistical institutes and the other statistical principles laid down in Article 2 of that Regulation, the Programme is intended to provide the overall framework for the development, production and dissemination of European statistics for 2021-2027. European statistics are to be developed, produced and disseminated under that framework and in accordance with the principles of the European statistics Code of Practice. That framework should respect the quality criteria referred to in Article 12(1) of Regulation (EC) No 223/2009 through close and coordinated cooperation within the European Statistical System (ESS). European statistics developed, produced and disseminated under this framework, will contribute to the implementation of the Union\u2019s policies as set out in the TFEU and further reflected in the Commission\u2019s strategic priorities. Through the Programme, the ESS will aim to maintain and improve its level of excellence in the statistical field. Likewise, the annual work programmes will aim to achieve the best possible output, taking into account the available resources at the regional, national and the Union level. Continuous research and innovation are considered as key drivers in modernising European statistics and in improving the quality of European statistics. Therefore investment through the multiannual work programme should concentrate on the development of new methods and methodologies as well as exploring new data sources for producing statistics. In implementing the specific objective referred to in Article 3(2)(f), the following actions shall be carried out: Economic and Monetary Union, globalisation and trade (1) providing high-quality statistics underpinning the Excessive Deficit Procedure, and, where feasible, the Recovery and Resilience Facility and the Technical support instrument, and underpinning the Union\u2019s annual cycle of economic monitoring and guidance; (2) providing and where necessary, enhancing the Principal European Economic Indicators; (3) providing statistics and methodological guidance on the statistical treatment of the investment and budgetary instruments in supporting economic convergence, financial stability and job creation; (4) providing statistics for own resource purposes and remunerations and pensions of Union staff; (5) better measuring of trade in goods and services, foreign direct investment, global value chains and the impact of globalisation on the Union economies. Internal market, innovation and digital transformation (1) providing high quality and reliable statistics for the internal market and key areas of innovation and research; (2) providing more and timelier statistics on collaborative economy and the impact of digitalisation on Union businesses and citizens; (3) providing statistics to support the European defence policy, subject to feasibility studies and duly taking into account the sensitivity of statistical data. Social dimension of Europe (1) providing high quality, timely and reliable statistics to support the European Pillar of Social Rights and the Union Skills Policy, including statistics on the labour market, employment, education and training, income, living conditions, poverty, inequality, social protection, gender based violence, undeclared work, and satellite accounts on skills; Where the development of new statistics is necessary, the data availability and the feasibility of producing statistics on satellite accounts on skills and on undeclared work need to be further examined within the ESS; (2) providing statistics related to the United Nations Convention on the Rights of Persons with Disabilities; (3) enriching statistics on migration in particular on the situation and integration of migrants and the education needs and qualification levels of asylum seekers; (4) developing modernised post-2021 Population and Housing Census programmes and population statistics; (5) providing and regularly updating projections and breakdown on the Union population. Sustainable development, natural resources and environment (1) monitoring the progress towards the Sustainable Development Goals (SDGs); (2) providing high-quality statistics underpinning the European Green Deal including further developing statistics in support of the Energy Strategy, the circular economy, climate-related statistics and the plastics strategy; Where the development of new statistics and indicators for the topics mentioned in the indent above is necessary, the data availability and the feasibility for producing statistics and indicators shall be further examined within the ESS; (3) providing key environmental statistics and indicators, including on waste, water, biodiversity, forests, land use and land cover, as well as environmental economic accounts; (4) providing freight and passengers\u2019 transport statistics to support the policies of the Union; (5) developing further indicators to monitor intermodality and modal shift towards more environmentally friendly transport modes; (6) providing timely and relevant data for the needs of the Common Agricultural Policy, Common Fisheries policy and policies related to the environment, food security and animal welfare. Economic, social and territorial cohesion (1) providing timely and comprehensive statistical indicators on regions, including the Union outermost regions, cities and rural areas, to monitor and evaluate the effectiveness of territorial development policies and to evaluate the territorial impacts of sectoral policies; (2) increasingly using geospatial data and systematically integrating and mainstreaming geospatial information management into statistical production; (3) examining within the ESS the feasibility of providing and then supporting the development of: (a) indicators on anti-money laundering; (b) indicators on the fight against financing of terrorism; (c) police and security statistics. Better communication of European statistics and its values by promoting it as a trustworthy source in tackling disinformation (1) systematically promoting European statistics as a trustworthy source of evidence and facilitating fact checkers, researchers and public authorities in their use of European statistics in tackling disinformation; (2) enhancing the existent dialogue with producers and with users of European statistics in order to improve and promote the use of European statistics by setting and implementing actions to increase statistical literacy for the benefit of the Union citizens, including entrepreneurs; (3) making it easier for users to access and understand statistics, including by providing attractive and interactive visualisations, more tailored services like on-demand data, and self-service analytics; (4) further developing and monitoring the quality assurance framework for European statistics, including through peer reviews of the Members States\u2019 compliance with the European statistics Code of Practice; (5) providing access to micro-data for research purposes in accordance with Article 23 of Regulation (EC) No 223/2009 while safeguarding the highest standards in the protection of data and statistical confidentiality. Reaping the benefits of data revolution and moving to trusted smart statistics (1) stepping-up the exploitation of new digital data sources in a multisource environment to produce new smart statistics in near real-time with trusted algorithms that are fit for purpose; (2) developing novel approaches to use privately held data through the adoption of privacy-preserving computation and secure multiparty computation methods; (3) promoting cutting-edge research and innovation in official statistics, including by making use of collaborative networks and providing European Statistical Training Programmes. Expanded partnerships and statistical cooperation (1) strengthening the ESS partnership and cooperation with the European System of Central Banks; (2) fostering partnerships with public and private data holders and the technology sector to facilitate access to data for statistical purposes, the integration of data from multiple sources and the use of latest technologies; (3) enhancing cooperation with research and academia, in particular as regards the use of new data sources, data analytics and the promotion of statistical literacy; (4) continuing the cooperation with international organisations and third countries for the benefit of global official statistics. ANNEX III LIST OF ANIMAL DISEASES AND ZOONOSES (1) Animal diseases referred to in Article 5(1), Article 9(1)(a), (b) and (c) and Article 28 of Regulation (EU) 2016/429; (2) Zoonoses and zoonotic agents referred to in Regulation (EC) No 2160/2003 and in Directive 2003/99/EC; (3) Transmissible spongiform encephalopathies as referred to in Regulation (EC) No 999/2001. ANNEX IV INDICATORS Objective Indicator Objectives laid down in Article 3(2)(a) 1. Number of new complaints in the area of free movement of goods and services, as well as Union legislation on public procurement. 2. Services Trade Restrictiveness Index. 3. Number of visits to the Your Europe portal. Objective laid down in Article 3(2)(a)(ii) 1. Number of cases of non-compliance in the area of goods, including online sales. 2. Number of joint market surveillance campaigns. Objective laid down in Article 3(2)(b) 1. Number of SMEs and clusters and business network organisations, as well as business support organisations, receiving support from the programme, in particular for internationalisation, digitalisation and sustainability. 2. Number of companies supported having concluded business partnerships. 3. Number of entrepreneurs benefitting from mentoring and mobility schemes, including young, new and female entrepreneurs, as well as other specific target groups. Objective laid down in Article 3(2)(c)(i) 1. Share of implementation of European standards as national standards by Member States in total amount of active European standards. Objective laid down in Article 3(2)(c)(ii) 1. Percentage of international financial reporting and auditing standards endorsed by the Union Objective laid down in Article 3(2)(d)(i) 1. Consumer condition index. Objective laid down in Article 3(2)(d)(ii) 1. Number of position papers and responses to public consultations in the field of financial services from beneficiaries. Objective laid down in Article 3(2)(e) 1. Number of successfully implemented national veterinary and phytosanitary programmes, including the number of successfully implemented emergency measures on plant pests and animal diseases. Objective laid down in Article 3(2)(f) 1. Impact of statistics published on the internet: number of web mentions and positive/negative opinions.", "summary": "Single Market Programme Single Market Programme SUMMARY OF: Regulation (EU) 2021/690 establishing a programme for the internal market, competitiveness, including small and medium-sized enterprises (SMEs), the area of plants, animals, food and feed, and European statistics (Single Market Programme) WHAT IS THE AIM OF THE REGULATION? It sets out the aims, budget, governance and funding rules of the first integrated single internal market programme. This brings together activities previously financed under 6 separate programmes. It runs from 2021 to 2027. KEY POINTS The programme\u2019s general aims are to: improve the functioning of the internal market, notably to protect and empower the public, consumers and businesses, especially SMEs, by enforcing EU law, facilitating market access and setting standardspromoting human, animal and plant health and animal welfarerespecting sustainable development and ensuring a high level of consumer protectionenhancing cooperation between national authorities, the European Commission and decentralised EU agencies; develop, produce and disseminate high-quality, comparable, timely and reliable European statistics to underpin the design, monitoring and evaluation of EU policiesassist the public, policymakers, authorities, businesses, academia and the media to make informed decisionshelp the above groups to participate actively in the democratic process. These overall aims are achieved through the following specific objectives: making the internal market more effective, especially with digital transformation, preventing and removing illegal obstacles (\u20ac452 million over the 7-year period) and ensuring only safe and compliant products may be offered for sale; strengthening the competitiveness and sustainability of SMEs, including various forms of support, promoting new business opportunities and developing industrial value chains (\u20ac1 billion); ensuring the effective functioning of the internal market through high-quality European and international standards (\u20ac221 million); promoting consumer interests and a high level of consumer protection and product safety, including in financial services (\u20ac200 million); contributing to a high level of health and safety for humans, animals and plants throughout the food chain, including eradicating animal diseases and plant pests, fighting antimicrobial resistance and developing sustainable food production and consumption (\u20ac1.7 billion); developing, producing, disseminating and communicating high-quality European statistics (\u20ac552 million). The 7-year budget to implement the programme is \u20ac4,208,041,000 (current prices). Up to 5% of the budget may be used for various technical and administrative purposes, such as preparation, monitoring, control, audit, evaluation and use of information technology networks. Non-EU countries may take part in the programme subject to certain conditions. These include the right of the European Anti-Fraud Office (OLAF) to carry out investigations, including on-the-spot checks and inspections, to protect the EU\u2019s finances. Article 8 and Annexes I (plant, animal, food and feed) and II (European statistics) set out the many activities eligible for funding under the programme\u2019s general and specific objectives. Legal entities* are eligible for funding if they are: based in an EU Member State or a linked overseas country or territory, or in a non-EU country associated with the programme; created under EU law or are an international organisation; based in a non-EU country not associated with the programme, but their activities are in line with its objectives. Article 10 sets out the entities which may receive a grant without a call for proposals. They range from national market surveillance authorities to the European Financial Reporting Advisory Group and the Bureau Europ\u00e9en des Unions de Consommateurs. Co-financing rules state that: in certain circumstances the programme may cover up to 100% of eligible costs. Elsewhere, the range is between 50% and 95%; activities may receive finance from the single market programme and other EU funds provided the contributions do not cover the same costs. The Commission: sets out work programmes by 30 April for the following year; monitors and reports on the programme\u2019s progress towards meeting its specific objectives, using indicators in Annex IV; prepares an annual report for the European Parliament and the Council on the activity of the International Financial Reporting Standards Foundation; provides an interim evaluation of the programme no later than 4 years after its start and a final evaluation at the time of its completion; presents the 2 evaluations to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions and makes them publicly available; consults the European Statistical System Committee and the European Statistical Advisory Committee when preparing the evaluations; implements user-friendly information and communication activities to raise awareness among the public, businesses and public administrations about finance available under the programme; may adopt various implementing and delegated acts. The legislation repeals Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014 from 31 December 2020. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND The single market is the backbone of the EU economy. It contributes to growth, competitiveness and jobs, while bringing consumers greater choice and lower prices. The programme aims to enable the public, consumers, businesses and public authorities throughout the EU to take full advantage of the opportunities on offer. For more information, see: Single Market Programme (European Commission); The first-ever financial programme to boost the Single Market is ready to kick-off \u2014 press release (European Commission); The single market over 2021-2027 \u2014 factsheet (European Commission). KEY TERMS Legal entity: an individual, company or organisation that has legal rights and obligations. MAIN DOCUMENT Regulation (EU) 2021/690 of the European Parliament and of the Council of 28 April 2021 establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014 (OJ L 153, 3.5.2021, pp. 1-47) last update 22.07.2021"}
{"article": "6.4.2021 EN Official Journal of the European Union L 115/1 DIRECTIVE (EU) 2021/555 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 March 2021 on control of the acquisition and possession of weapons (codification) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Council Directive 91/477/EEC (3) has been substantially amended several times (4). In the interests of clarity and rationality, that Directive should be codified. (2) Directive 91/477/EEC established an accompanying measure for the internal market. It created a balance between, on the one hand, the commitment to ensure a certain freedom of movement for some firearms and their essential components within the Union, and, on the other hand, the need to control that freedom using security guarantees suited to those products. (3) Police intelligence evidence shows an increase in the use of converted weapons within the Union. It is therefore essential to ensure that such convertible weapons are included within the definition of \u2018firearm\u2019 for the purposes of this Directive. (4) The activities of a dealer include not only the manufacturing but also the modification or conversion of firearms, essential components and ammunition, such as the shortening of a complete firearm, leading to a change in their category or subcategory. Purely private, non-commercial activities, such as hand-loading and reloading of ammunition from ammunition components for own use, or modifications of firearms or essential components owned by the person concerned, such as changes to the stock or sight, or maintenance to address wear and tear of essential components, should not be considered to be activities that only a dealer would be permitted to undertake. (5) For the purposes of this Directive, the definition of \u2018broker\u2019 should cover any natural or legal person, including partnerships, and the term \u2018supply\u2019 should be deemed to include lending and leasing. Since brokers provide services similar to those supplied by dealers, they should also be covered by this Directive in respect of the obligations of dealers that are relevant to brokers\u2019 activities, to the extent that they are in a position to fulfil those obligations and in so far as those obligations are not fulfilled by a dealer as regards the same underlying transaction. (6) It is useful to determine categories of firearms the acquisition and possession of which by private persons should be prohibited or should be subject to authorisation or declaration. (7) Authorisations for the acquisition and possession of firearms should, as far as possible, involve a single administrative procedure. (8) Once firearms are lawfully acquired and possessed in accordance with this Directive, national provisions concerning the carrying of weapons, hunting or target shooting should apply. (9) This Directive does not affect the right of Member States to take measures to prevent illegal trade in weapons. (10) It is necessary that Member States keep a computerised data-filing system, either centralised or decentralised, which guarantees to authorised authorities access to the data-filing systems in which the necessary information regarding each firearm is recorded. Access by police, judicial and other authorised authorities to the information contained in the computerised data-filing system must be subject to compliance with Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms. (11) In order to increase the traceability of all firearms and essential components and to facilitate their free movement, all firearms or their essential components should be marked with a clear, permanent and unique marking and registered in the data-filing systems of the Member States. (12) The records held in the data-filing systems should contain all information allowing a firearm to be linked to its owner and should record the name of the manufacturer or brand, the country or place of manufacture, the type, make, model, calibre and serial number of the firearm and any unique marking applied to the frame or receiver of the firearm. Essential components other than the frame or receiver should be recorded in the data-filing systems under the record relating to the firearm to which they are to be fitted. (13) In order to facilitate the tracing of weapons, it is necessary to use alphanumeric codes and to include in the marking the year of manufacture of the weapon, if the year is not part of the serial number. (14) To prevent markings from being easily erased and to clarify to which essential components the marking should be affixed, common Union rules on marking are necessary. Those rules should apply only to firearms or essential components manufactured or imported into the Union on or after 14 September 2018, when they are placed on the market, while firearms and parts manufactured or imported into the Union before that date should remain covered by the marking and registration requirements under Directive 91/477/EEC that were applicable until that date. (15) Due to the special nature of the activity of dealers and of brokers, it is necessary that Member States exercise strict control over such activity, in particular by verifying the professional integrity and abilities of dealers and of brokers. (16) In view of the dangerous nature and durability of firearms and essential components, in order to ensure that competent authorities are able to trace firearms and essential components for the purpose of administrative and criminal proceedings and taking into account national procedural law, it is necessary that records in the data-filing systems be retained for a period of 30 years after the destruction of the firearms or essential components concerned. Access to those records and all related personal data should be restricted to competent authorities and should be permitted for only up to 10 years after the destruction of the firearm or essential components concerned, for the purpose of granting or withdrawing authorisations or for customs proceedings, including the possible imposition of administrative penalties, and for up to 30 years after the destruction of the firearm or essential components concerned, where that access is necessary for the enforcement of criminal law. (17) The efficient sharing of information between dealers and brokers, on the one hand, and national competent authorities, on the other, is important for the effective operation of the data-filing systems. Dealers and brokers should therefore provide information without undue delay to the national competent authorities. To facilitate that, national competent authorities should establish a means of electronic connection accessible to dealers and brokers, which can include submission of the information by email or directly through a database or other registry. (18) As a general rule, the acquisition of firearms by persons convicted by a final court judgment of certain serious criminal offences should be prohibited. (19) Member States should have a monitoring system in place in order to ensure that the conditions for a firearms authorisation are met throughout its duration. Member States should decide whether or not the assessment is to involve a prior medical or psychological test. (20) Without prejudice to national laws addressing professional liability, the assessment of relevant medical or psychological information should not be presumed to assign any liability to the medical professional or other persons providing such information where firearms possessed in accordance with this Directive are misused. (21) Firearms and ammunition should be stored in a secure manner when not immediately supervised. If stored otherwise than in a safe, firearms and ammunition should be stored separately from each other. When the firearm and ammunition are to be handed over to a carrier for transport, that carrier should be responsible for proper supervision and storage. Criteria for proper storage and for safe transportation should be defined by national law, taking into account the number and category of the firearms and ammunition concerned. (22) This Directive should not affect Member States\u2019 rules which allow lawful transactions involving firearms, essential components and ammunition to be arranged by means of mail order, the internet or distance contracts as defined in Directive 2011/83/EU of the European Parliament and of the Council (5), for example by way of online auction catalogues or classified advertisements, telephone or email. However, it is essential that the identities of parties to such transactions and their lawful ability to enter into such transactions be capable of being checked and actually checked. As regards purchasers, it is therefore appropriate to ensure that their identity and, where relevant, the fact that they are authorised to acquire a firearm, essential components or ammunition be checked by a licensed or authorised dealer or broker, or by a public authority or a representative of such authority, prior to, or at the latest upon, delivery. (23) For the most dangerous firearms, strict rules should be laid down in this Directive in order to ensure that those firearms are, with some limited and duly reasoned exceptions, not allowed to be acquired, possessed or traded. Where those rules are not respected, Member States should take all appropriate measures, which might include the impounding of those firearms. (24) Member States should, however, have the possibility of authorising the acquisition and possession of firearms, essential components and ammunition classified in category A, when necessary for educational, cultural, including film and theatre, research or historical purposes. Authorised persons could include, inter alia, armourers, proof houses, manufacturers, certified experts, forensic scientists and, in certain cases, those involved in film or television recordings. Member States should also be allowed to authorise individuals to acquire and possess firearms, essential components and ammunition classified in category A for national defence, such as in the context of voluntary military training provided under national law. (25) Member States should be able to choose to grant authorisations to recognised museums and collectors for the acquisition and possession of firearms, essential components and ammunition classified in category A when necessary for historical, cultural, scientific, technical, educational or heritage purposes, provided that such museums and collectors demonstrate, prior to being granted such an authorisation, that they have taken the necessary measures to address any risks to public security or public order, including by way of proper storage. Any such authorisation should take into account and reflect the specific situation, including the nature of the collection and its purposes, and Member States should ensure that a system is in place for monitoring collectors and collections. (26) Dealers and brokers should not be prevented from handling firearms, essential components and ammunition classified in category A in cases where the acquisition and possession of such firearms, essential components and ammunition is exceptionally allowed, where their handling is necessary for the purposes of deactivation or conversion, or where otherwise permitted under this Directive. Dealers and brokers should also not be prevented from handling such firearms, essential components and ammunition in cases not covered by this Directive, such as firearms, essential components and ammunition to be exported outside the Union or weapons to be acquired by the armed forces, the police or the public authorities. (27) Dealers and brokers should be able to refuse to complete any suspicious transaction for the acquisition of complete rounds of ammunition or live primer components of ammunition. A transaction could be considered suspicious if, for example, it involved quantities uncommon for the private use envisaged, if the purchaser appears unfamiliar with the use of the ammunition or if the purchaser insists on paying in cash while being unwilling to provide proof of his or her identity. Dealers and brokers should also be able to report such suspicious transactions to the competent authorities. (28) The risk of acoustic weapons and other types of blank-firing weapons being converted into real firearms is high. It is therefore essential to address the problem of such converted firearms being used in the commission of criminal offences. Furthermore, to avoid the risk of alarm and signal weapons being manufactured in such a way that they are capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant, the Commission should adopt technical specifications in order to ensure that they cannot be so converted. (29) Taking into consideration the high risk of reactivating improperly deactivated firearms and in order to enhance security across the Union, such firearms should be covered by this Directive. The definition of \u2018deactivated firearms\u2019 should reflect the general principles of deactivation of firearms as provided for by the Protocol against the Illicit Manufacturing of and Trafficking of Firearms, their Parts and Components and Ammunition, attached to Council Decision 2014/164/EU (6), which transposes that Protocol into the Union legal framework. (30) The European firearms pass should be regarded as the main document needed by target shooters and other persons authorised in accordance with this Directive for the possession of a firearm during a journey to another Member State. Member States should not make the acceptance of the European firearms pass conditional upon the payment of any fee or charge. (31) The provisions of this Directive relating to the European firearms pass should also refer to firearms classified in category A, without prejudice to Member States\u2019 right to choose to apply more stringent rules. (32) In order to facilitate the tracing of firearms and to combat efficiently the illicit trafficking and manufacturing of firearms, their parts and ammunition, the exchange of information between Member States is necessary. (33) Firearms which are designed for military use, such as the AK47 and the M16, and which are equipped to operate on the basis of selective fire, where they may be manually adjusted between automatic and semi-automatic firing modes, should be classified as category A firearms and should therefore be prohibited for civilian use. If converted into semi-automatic firearms, they should be classified under point 6 of category A. (34) Some semi-automatic firearms can easily be converted to automatic firearms, thus posing a threat to security. Even in the absence of such conversion, certain semi-automatic firearms might be very dangerous when their capacity, in terms of the number of rounds, is high. Therefore, semi-automatic firearms with a fixed loading device allowing a high number of rounds to be fired, as well as semi-automatic firearms in combination with a detachable loading device having a high capacity, should be prohibited for civilian use. The mere possibility of fitting a loading device with a capacity exceeding 10 rounds for long firearms and 20 rounds for short firearms should not determine the classification of the firearm in a specific category. (35) Without prejudice to the renewal of authorisations in accordance with this Directive, semi automatic firearms which use rimfire percussion, including those with a calibre of .22 or smaller, should not be classified in category A unless they have been converted from automatic firearms. (36) Objects which have the physical appearance of a firearm (replicas), but which are manufactured in such a way that they cannot be converted to expel a shot, bullet or projectile by the action of a combustible propellant, should not be covered by this Directive. (37) Where Member States have national laws regulating antique weapons, such weapons should not be subject to this Directive. However, reproductions of antique weapons do not have the same historical importance or interest attached to them and can be constructed using modern techniques which can improve their durability and accuracy. Therefore, such reproductions should be included within the scope of this Directive. This Directive should not be applicable to other items, such as airsoft devices, which are not covered by the definition of \u2018firearm\u2019 and are therefore not regulated by this Directive. (38) In order to improve the functioning of the exchange of information between Member States, it would be helpful if the Commission assessed the necessary elements of a system to support such exchange of information contained in the computerised data-filing systems in place in Member States, including the feasibility of enabling each Member State to access such a system. That system could use a module of the internal market information system (IMI), established by Regulation (EU) No 1024/2012 of the European Parliament and of the Council (7), specifically customised for firearms. Such exchange of information between Member States should take place in compliance with the rules on data protection laid down in Regulation (EU) 2016/679 of the European Parliament and of the Council (8). Where a competent authority needs to have access to the criminal records of a person applying for an authorisation to acquire or possess a firearm, that authority should be able to obtain that information under Council Framework Decision 2009/315/JHA (9). The Commission\u2019s assessment could be accompanied, if appropriate, by a legislative proposal taking into account existing instruments regarding the exchange of information. (39) In order to ensure appropriate exchange of information by electronic means between Member States concerning authorisations granted for the transfer of firearms to another Member State and concerning refusals to grant authorisations to acquire or possess a firearm, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of establishing provisions enabling the Member States to create such a system of exchange of information. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (10). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (40) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11). (41) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. (42) Regulation (EU) 2016/679 should apply to the processing of personal data within the framework of this Directive. Where personal data collected under this Directive are processed for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, the authorities processing those data should comply with rules adopted pursuant to Directive (EU) 2016/680 of the European Parliament and of the Council (12). (43) Since the objectives of this Directive cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (44) As regards Iceland and Norway, this Directive constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters\u2019 association with the implementation, application and development of the Schengen acquis (13) which fall within the area referred to in Article 1 of Council Decision 1999/437/EC (14). (45) As regards Switzerland, this Directive constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (15) which fall within the area referred to in Article 1 of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (16). (46) As regards Liechtenstein, this Directive constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (17) which fall within the area referred to in Article 1 of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (18). (47) This Directive should be without prejudice to the obligations of the Member States relating to the time limits for the transposition into national law of the Directives set out in Annex III, Part B, HAVE ADOPTED THIS DIRECTIVE: CHAPTER 1 SCOPE Article 1 1. For the purposes of this Directive, the following definitions apply: (1) \u2018firearm\u2019 means any portable barrelled weapon that expels, is designed to expel or may be converted to expel a shot, bullet or projectile by the action of a combustible propellant, unless it is excluded from this definition for one of the reasons listed in Part III of Annex I. Firearms are classified in Part II of Annex I. An object shall be considered to be capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if: (a) it has the appearance of a firearm; and (b) as a result of its construction or the material from which it is made, it can be so converted; (2) \u2018essential component\u2019 means the barrel, the frame, the receiver, whether an upper or lower receiver, where applicable, the slide, the cylinder, the bolt or the breech block, which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted; (3) \u2018ammunition\u2019 means the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the Member State concerned; (4) \u2018alarm and signal weapons\u2019 means devices with a cartridge holder which are designed to fire only blanks, irritants, other active substances or pyrotechnic signalling rounds and which are not capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant; (5) \u2018salute and acoustic weapons\u2019 means firearms specifically converted for the sole use of firing blanks, for use such as in theatre performances, photographic sessions, film and television recordings, historical re-enactments, parades, sporting events and training; (6) \u2018deactivated firearms\u2019 means firearms that have been rendered permanently unfit for use by deactivation, ensuring that all essential components of the firearm in question have been rendered permanently inoperable and incapable of removal, replacement or modification in a manner that would permit the firearm to be reactivated in any way; (7) \u2018museum\u2019 means a permanent institution in the service of society and its development, open to the public, which acquires, conserves, researches and exhibits firearms, essential components or ammunition for historical, cultural, scientific, technical, educational, heritage or recreational purposes, and which is recognised as such by the Member State concerned; (8) \u2018collector\u2019 means any natural or legal person dedicated to the gathering and conservation of firearms, essential components or ammunition for historical, cultural, scientific, technical, educational or heritage purposes, and recognised as such by the Member State concerned; (9) \u2018dealer\u2019 means any natural or legal person whose trade or business consists wholly or partly of either of the following: (a) the manufacture, trade, exchange, hiring out, repair, modification or conversion of firearms or essential components; (b) the manufacture, trade, exchange, modification or conversion of ammunition; (10) \u2018broker\u2019 means any natural or legal person, other than a dealer, whose trade or business consists wholly or partly of either of the following: (a) the negotiation or arrangement of transactions for the purchase, sale or supply of firearms, essential components or ammunition; (b) arranging the transfer of firearms, essential components or ammunition within a Member State, from one Member State to another Member State, from a Member State to a third country or from a third country to a Member State; (11) \u2018illicit manufacturing\u2019 means the manufacturing or assembly of firearms, their essential components and ammunition: (a) from any essential component of such firearms illicitly trafficked; (b) without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or (c) without marking firearms at the time of manufacture in accordance with Article 4; (12) \u2018illicit trafficking\u2019 means the acquisition, sale, delivery, movement or transfer of firearms, their essential components or ammunition from or through the territory of one Member State to that of another Member State, if any of the Member States concerned does not authorise it in accordance with this Directive, or if the firearms, essential components or ammunition are not marked in accordance with Article 4; (13) \u2018tracing\u2019 means the systematic tracking of firearms and, where possible, their essential components and ammunition from manufacturer to purchaser, for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and illicit trafficking. 2. For the purposes of this Directive, a person shall be considered to be a resident of the country indicated by the address appearing on an official document showing his or her place of residence, such as a passport or a national identity card, which, in a check on acquisition or on possession, is submitted to the competent authorities of a Member State or to a dealer or broker. If a person\u2019s address does not appear on his or her passport or national identity card, his or her country of residence shall be determined on the basis of any other official proof of residence recognised by the Member State concerned. 3. A \u2018European firearms pass\u2019 shall be issued on request by the competent authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years, which may be extended, and shall contain the information set out in Annex II. It shall be non-transferable and shall record the firearm or firearms possessed and used by the holder of the pass. It shall always be in the possession of the person using the firearm and any change concerning possession of or the characteristics of the firearm, as well as any loss or theft thereof, shall be indicated on the pass. Article 2 1. This Directive is without prejudice to the application of national provisions concerning the carrying of weapons, hunting or target shooting, using weapons lawfully acquired and possessed in accordance with this Directive. 2. This Directive shall not apply to the acquisition or possession of weapons and ammunition, in accordance with national law, by the armed forces, the police or the public authorities. Nor shall it apply to transfers regulated by Directive 2009/43/EC of the European Parliament and of the Council (19). Article 3 Member States may adopt in their legislation provisions which are more stringent than those laid down in this Directive, subject to the rights conferred on residents of the Member States pursuant to Article 17(2). CHAPTER 2 HARMONISATION OF LEGISLATION CONCERNING FIREARMS Article 4 1. With regard to firearms manufactured or imported into the Union on or after 14 September 2018, Member States shall ensure that any such firearm, or any essential component, placed on the market has been: (a) provided with a clear, permanent and unique marking without delay after manufacture and at the latest before its placement on the market, or without delay after importation into the Union; and (b) registered in compliance with this Directive without delay after manufacture and at the latest before its placement on the market, or without delay after importation into the Union. 2. The unique marking referred to in point (a) of paragraph 1 shall include the name of the manufacturer or brand, the country or place of manufacture, the serial number and the year of manufacture, if not already part of the serial number, and the model where feasible. This shall be without prejudice to the affixing of the manufacturer\u2019s trademark. Where an essential component is too small to be marked in compliance with this Article, it shall be marked at least with a serial number or an alphanumeric or digital code. The marking requirements for firearms or essential components that are of particular historical importance shall be determined in accordance with national law. Member States shall ensure that each elementary package of complete ammunition is marked in such a way as to indicate the name of the manufacturer, the batch or lot identification number, the calibre and the type of ammunition. For the purposes of paragraph 1 and this paragraph, Member States may choose to apply the provisions of the Convention for the Reciprocal Recognition of Proof Marks on Small Arms of 1 July 1969 (the \u20181969 Convention\u2019). Furthermore, Member States shall ensure, at the time of transfer of a firearm or its essential components from government stocks to permanent civilian use, the unique marking, as provided for under paragraph 1, permitting identification of the transferring entity. 3. The Commission shall adopt implementing acts establishing technical specifications for the marking. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2). 4. Each Member State shall establish a system for the regulation of the activities of dealers and brokers. Such systems shall include at least the following measures: (a) the registration of dealers and brokers operating within the territory of that Member State; (b) the licensing or authorisation of the activities of dealers and brokers within the territory of that Member State; and (c) a check of the private and professional integrity and of the relevant abilities of the dealer or broker concerned. In the case of a legal person, the check shall be both on the legal person and on the natural person or persons directing the undertaking. 5. Member States shall ensure the establishment and maintenance of a computerised data-filing system, either centralised or decentralised, which guarantees to authorised authorities access to the data-filing systems in which each firearm subject to this Directive is recorded. That data-filing system shall record all information relating to firearms which is needed in order to trace and identify those firearms, including: (a) the type, make, model, calibre and serial number of each firearm and the mark applied to its frame or receiver as a unique marking in accordance with paragraph 1, which shall serve as the unique identifier of each firearm; (b) the serial number or unique marking applied to the essential components, where that differs from the marking on the frame or receiver of each firearm; (c) the names and addresses of the suppliers and of the persons acquiring or possessing the firearm, together with the relevant date or dates; and (d) any conversions or modifications to a firearm leading to a change in its category or subcategory, including its certified deactivation or destruction and the relevant date or dates. Member States shall ensure that the record of firearms and the essential components, including the related personal data, is retained in the data-filing systems by the competent authorities for a period of 30 years after the destruction of the firearms or essential components in question. The records of firearms and essential components referred to in the first subparagraph of this paragraph and the related personal data shall be capable of being accessed: (a) by the authorities competent to grant or withdraw authorisations referred to in Article 9 or 10 or by the authorities competent for customs proceedings, for a period of 10 years after the destruction of the firearm or the essential components in question; and (b) by the authorities competent for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, for a period of 30 years after the destruction of the firearm or the essential components in question. Member States shall ensure that personal data are deleted from the data-filing systems upon expiry of the periods specified in the second and third subparagraphs. This shall be without prejudice to cases in which specific personal data have been transferred to an authority competent for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties and are used in that specific context, or to other authorities competent for a compatible purpose provided for by national law. In such cases, the processing of such data by the competent authorities shall be regulated by the national law of the Member State concerned, in full compliance with Union law, in particular on data protection. Throughout their period of activity, dealers and brokers shall be required to maintain a register in which each firearm and each essential component subject to this Directive that is received or disposed of by them is recorded, together with particulars enabling the firearm or essential component concerned to be identified and traced, in particular the type, make, model, calibre and serial number thereof and the names and addresses of the suppliers and of the persons acquiring it. Upon the cessation of their activities, dealers and brokers shall deliver that register to the national authorities responsible for the data-filing systems provided for in the first subparagraph. Member States shall ensure that dealers and brokers established in their territory report transactions involving firearms or essential components without undue delay to the national competent authorities, that dealers and brokers have an electronic connection to those authorities for such reporting purposes and that the data-filing systems are updated immediately upon receipt of information concerning such transactions. 6. Member States shall ensure that all firearms may be linked to their owner at any moment. Article 5 Without prejudice to Article 3, Member States shall allow the acquisition and possession of firearms only by persons who have been granted a licence or, with respect to firearms classified in category C, persons who are specifically permitted to acquire and possess such firearms in accordance with national law. Article 6 1. Without prejudice to Article 3, Member States shall permit the acquisition and possession of firearms only by persons who have good cause and who: (a) are at least 18 years of age, except in relation to the acquisition, other than through purchase, and possession of firearms for hunting and target shooting, provided that in that case persons under 18 years of age have parental permission, or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence, or are within a licensed or otherwise approved training centre, and the parent, or an adult with a valid firearms or hunting licence, assumes responsibility for proper storage pursuant to Article 7; and (b) are not likely to be a danger to themselves or others, to public order or to public safety; the fact of having been convicted of a violent intentional crime shall be considered to be indicative of such danger. 2. Member States shall have in place a monitoring system, which they may operate on a continuous or non-continuous basis, to ensure that the conditions of authorisation set by national law are met throughout the duration of the authorisation and, inter alia, relevant medical and psychological information is assessed. The specific arrangements shall be determined in accordance with national law. Where any of the conditions of authorisation is no longer met, Member States shall withdraw the respective authorisation. Member States may not prohibit persons resident within their territory from possessing a firearm acquired in another Member State unless they prohibit the acquisition of the same type of firearm within their own territory. 3. Member States shall ensure that an authorisation to acquire and an authorisation to possess a firearm classified in category B shall be withdrawn if the person who was granted that authorisation is found to be in possession of a loading device apt to be fitted to centre-fire semi-automatic firearms or repeating firearms which: (a) can hold more than 20 rounds; or (b) in the case of long firearms, can hold more than 10 rounds, unless that person has been granted an authorisation under Article 9 or an authorisation which has been confirmed, renewed or prolonged under Article 10(5). Article 7 In order to minimise the risk of firearms and ammunition being accessed by unauthorised persons, Member States shall establish rules on the proper supervision of firearms and ammunition and rules on their proper storage in a secure manner. Firearms and their ammunition shall not be readily accessible together. Proper supervision shall mean that the person lawfully possessing the firearm or the ammunition concerned has control over it during its transportation and use. The level of scrutiny of such proper storage arrangements shall reflect the number and category of the firearms and ammunition concerned. Article 8 Member States shall ensure that, in cases involving the acquisition and selling of firearms, essential components or ammunition classified in category A, B or C by means of distance contracts as defined in point (7) of Article 2 of Directive 2011/83/EU, the identity, and where required, the authorisation of the purchaser of the firearm, essential components or ammunition are checked prior to, or at the latest upon, delivery thereof to that person, by: (a) a licensed or authorised dealer or broker; or (b) a public authority or a representative of that authority. Article 9 1. Without prejudice to Article 2(2), Member States shall take all appropriate measures to prohibit the acquisition and possession of the firearms, the essential components and the ammunition classified in category A. They shall ensure that those firearms, essential components and ammunition unlawfully held in contravention of that prohibition are impounded. 2. For the protection of the security of critical infrastructure, commercial shipping, high-value convoys and sensitive premises, as well as for national defence, educational, cultural, research and historical purposes, and without prejudice to paragraph 1, the national competent authorities may grant, in individual cases, exceptionally and in a duly reasoned manner, authorisations for firearms, essential components and ammunition classified in category A where this is not contrary to public security or public order. 3. Member States may choose to grant to collectors, in individual special cases, exceptionally and in a duly reasoned manner, authorisations to acquire and possess firearms, essential components and ammunition classified in category A, subject to strict conditions on security, including the demonstration to the national competent authorities that measures are in place to address any risks to public security or public order and that the firearms, essential components or ammunition concerned are stored with a level of security proportionate to the risks associated with unauthorised access to such items. Member States shall ensure that collectors authorised under the first subparagraph of this paragraph are identifiable within the data-filing systems referred to in Article 4. Such authorised collectors shall be obliged to maintain a register of all firearms in their possession classified in category A, which shall be accessible to the national competent authorities. Member States shall establish an appropriate monitoring system with respect to such authorised collectors, taking all relevant factors into account. 4. Member States may authorise dealers or brokers, in their respective professional capacities, to acquire, manufacture, deactivate, repair, supply, transfer and possess firearms, essential components and ammunition classified in category A, subject to strict conditions regarding security. 5. Member States may authorise museums to acquire and possess firearms, essential components and ammunition classified in category A, subject to strict conditions regarding security. 6. Member States may authorise target shooters to acquire and possess semi-automatic firearms classified in point 6 or 7 of category A, subject to the following conditions: (a) a satisfactory assessment of relevant information arising from the application of Article 6(2); (b) provision of proof that the target shooter concerned is actively practising for or participating in shooting competitions recognised by an officially recognised shooting sports organisation of the Member State concerned or by an internationally established and officially recognised shooting sport federation; and (c) provision of a certificate from an officially recognised shooting sports organisation confirming that: (i) the target shooter is a member of a shooting club and has been regularly practising target shooting in it for at least 12 months; and (ii) the firearm in question fulfils the specifications required for a shooting discipline recognised by an internationally established and officially recognised shooting sport federation. As regards firearms classified in point 6 of category A, Member States applying a military system based on general conscription and having in place over the last 50 years a system of transfer of military firearms to persons leaving the army after fulfilling their military duties may grant to those persons, in their capacity as a target shooter, an authorisation to keep one firearm used during the mandatory military period. The relevant public authority shall transform those firearms into semi-automatic firearms and shall periodically check that the persons using such firearms do not represent a risk to public security. The provisions set out in points (a), (b) and (c) of the first subparagraph shall apply. 7. Authorisations granted under this Article shall be reviewed periodically at intervals not exceeding five years. Article 10 1. No one may acquire a firearm classified in category B within the territory of a Member State unless that Member State has authorised him or her to do so. No such authorisation may be given to a resident of another Member State without that Member State\u2019s prior agreement. 2. No one may be in possession of a firearm classified in category B within the territory of a Member State unless that Member State has so authorised him or her. If the person is a resident of another Member State, that other Member State shall be informed accordingly. 3. An authorisation to acquire, and an authorisation to possess, a firearm classified in category B may take the form of a single administrative decision. 4. Member States may consider granting persons who satisfy the conditions for the granting of an authorisation for a firearm a multiannual licence for the acquisition and possession of all firearms subject to authorisation, without prejudice to: (a) the obligation to notify the competent authorities of transfers; (b) the periodic verification that those persons continue to satisfy the conditions; and (c) the maximum limits for possession laid down in national law. Authorisations for possession of firearms shall be reviewed periodically, at intervals not exceeding five years. An authorisation may be renewed or prolonged if the conditions on the basis of which it was granted are still fulfilled. 5. Member States may decide to confirm, renew or prolong authorisations for semi-automatic firearms classified in point 6, 7 or 8 of category A in respect of a firearm which was classified in category B, and lawfully acquired and registered, before 13 June 2017, subject to the other conditions laid down in this Directive. Furthermore, Member States may allow such firearms to be acquired by other persons authorised by Member States in accordance with this Directive. 6. Member States shall lay down rules to ensure that persons holding authorisations for firearms of category B in force under national law on 28 July 2008 do not need to apply for a licence or permit regarding firearms they held in categories C or D before that date. However, any transfer of firearms of categories C or D shall be subject to the transferee obtaining or having a licence or being specifically permitted to possess those firearms in accordance with national law. Article 11 1. No one may be in possession of a firearm classified in category C unless he or she has declared it to the authorities of the Member State in which that firearm is held. Member States may, as regards firearms acquired before 14 September 2018, suspend the requirement to declare firearms classified in point 5, 6 or 7 of category C until 14 March 2021. 2. Every seller, dealer or private person shall inform the authorities of the Member State in which it takes place of every transfer or handing over of a firearm classified in category C, giving the particulars by which the firearm and the person acquiring it may be identified. If the person acquiring such a firearm is a resident of another Member State, that other Member State shall be informed of the acquisition by the Member State in which the acquisition took place and by the person acquiring the firearm. 3. If a Member State prohibits or makes subject to authorisation the acquisition and possession within its territory of a firearm classified in category B or C, it shall inform the other Member States, which shall expressly include a statement to that effect on any European firearms pass they issue for such a firearm, pursuant to Article 17(2). Article 12 1. The handing over of a firearm classified in category A, B or C to a person who is not resident in the Member State in question shall be permitted, subject to compliance with the obligations laid down in Articles 9, 10 and 11, where: (a) the person acquiring it has been authorised in accordance with Article 16, to effect himself or herself a transfer to his or her country of residence; (b) the person acquiring it submits a written declaration testifying to and justifying his or her intention to be in possession of the firearm in the Member State of acquisition, provided that he or she fulfils the legal conditions for possession in that Member State. 2. Member States may authorise the temporary handing over of firearms in accordance with procedures which they shall lay down. Article 13 1. The arrangements for the acquisition and possession of ammunition shall be the same as those for the possession of the firearms for which the ammunition is intended. The acquisition of loading devices for centre-fire semi-automatic firearms which can hold more than 20 rounds or more than 10 rounds in the case of long firearms shall be permitted only for persons who are granted an authorisation under Article 9 or an authorisation which has been confirmed, renewed or prolonged under Article 10(5). 2. Dealers and brokers may refuse to complete any transaction for the acquisition of complete rounds of ammunition, or components of ammunition, which they reasonably consider to be suspicious owing to its nature or scale, and shall report any such attempted transaction to the competent authorities. Article 14 1. Member States shall take measures to ensure that devices with a cartridge holder which are designed to fire only blanks, irritants, other active substances or pyrotechnic signalling rounds are not capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant. 2. Member States shall classify as firearms devices with a cartridge holder which are designed to fire only blanks, irritants, other active substances or pyrotechnic signalling rounds, and which are capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant. 3. The Commission shall adopt implementing acts laying down technical specifications for alarm and signal weapons manufactured or imported into the Union on or after 14 September 2018 to ensure that they are not capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2). Article 15 1. Member States shall make arrangements for the deactivation of firearms to be verified by a competent authority in order to ensure that the modifications made to a firearm render all its essential components permanently inoperable and incapable of removal, replacement or modification in a manner that would permit the firearm to be reactivated in any way. Member States shall, in the context of that verification, provide for the issuance of a certificate and record attesting to the deactivation of the firearm and the apposition of a clearly visible mark to that effect on the firearm. 2. The Commission shall adopt implementing acts laying down deactivation standards and techniques to ensure that all essential components of a firearm are rendered permanently inoperable and incapable of removal, replacement or modification in a manner that would permit the firearm to be reactivated in any way. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2). 3. The implementing acts referred to in paragraph 2 shall not apply to firearms deactivated prior to the date of application of those implementing acts, unless those firearms are transferred to another Member State or placed on the market subsequent to that date. 4. Member States may notify to the Commission within two months of 13 June 2017 the national deactivation standards and techniques they applied before 8 April 2016, justifying the reasons for which the level of security ensured by those national deactivation standards and techniques is equivalent to that ensured by the technical specifications for deactivation of firearms set out in Annex I to Commission Implementing Regulation (EU) 2015/2403 (20) as applicable on 8 April 2016. 5. When Member States notify the Commission in accordance with paragraph 4, the Commission shall, at the latest 12 months after notification, adopt implementing acts deciding whether the national deactivation standards and techniques thus notified ensured that firearms were deactivated with a level of security equivalent to that ensured by the technical specifications for deactivation of firearms set out in Annex I to Implementing Regulation (EU) 2015/2403 as applicable on 8 April 2016. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2). 6. Until the date of application of the implementing acts referred to in paragraph 5, any firearm deactivated in accordance with the national deactivation standards and techniques applied before 8 April 2016 shall, when transferred to another Member State or placed on the market, comply with the technical specifications for deactivation of firearms set out in Annex I to Implementing Regulation (EU) 2015/2403. 7. Firearms deactivated before 8 April 2016 in accordance with the national deactivation standards and techniques that have been found to ensure a level of security equivalent to that ensured by the technical specifications for deactivation of firearms set out in Annex I to Implementing Regulation (EU) 2015/2403, as applicable on 8 April 2016, shall be considered to be deactivated firearms, including when they are transferred to another Member State or placed on the market after the date of application of the implementing acts referred to in paragraph 5. CHAPTER 3 FORMALITIES FOR THE MOVEMENT OF WEAPONS WITHIN THE UNION Article 16 1. Firearms may, without prejudice to Article 17, be transferred from one Member State to another only in accordance with the procedure laid down in this Article. That procedure shall also apply in respect of transfers of firearms following a sale by means of a distance contract as defined in point (7) of Article 2 of Directive 2011/83/EU. 2. Where a firearm is to be transferred to another Member State, the person concerned shall, before it is taken there, supply the following particulars to the Member State in which such firearm is situated: (a) the names and addresses of the person selling or disposing of the firearm and of the person purchasing or acquiring it or, where appropriate, of the owner; (b) the address to which the firearm is to be consigned or transported; (c) the number of firearms to be consigned or transported; (d) the particulars enabling the firearm to be identified and also an indication that the firearm has undergone a check in accordance with the 1969 Convention; (e) the means of transfer; (f) the date of departure and the estimated date of arrival. The information referred to in points (e) and (f) need not be supplied where the transfer takes place between dealers. The Member State shall examine the conditions under which the transfer of the firearm is to be carried out, in particular with regard to security. Where the Member State authorises such transfer, it shall issue a licence incorporating all the particulars referred to in the first subparagraph. Such licence shall accompany the firearm until it reaches its destination; it shall be produced whenever so required by the authorities of the Member States. 3. In the case of the transfer of firearms, other than weapons of war, excluded from the scope of this Directive pursuant to Article 2(2), each Member State may grant dealers the right to effect transfers of firearms from its territory to a dealer established in another Member State without the prior authorisation referred to in paragraph 2 of this Article. To that end, it shall issue an authorisation valid for no more than three years, which may at any time be suspended or cancelled by reasoned decision. A document referring to that authorisation shall accompany the firearm until it reaches its destination. That document shall be produced whenever so required by the authorities of the Member States. Prior to the date of transfer, the dealer shall communicate to the authorities of the Member State from which the transfer is to be effected all the particulars listed in the first subparagraph of paragraph 2. Those authorities shall carry out inspections, where appropriate on the spot, to verify the correspondence between the information communicated by the dealer and the actual characteristics of the transfer. The information shall be communicated by the dealer within a period allowing sufficient time. 4. Each Member State shall supply the other Member States with a list of firearms the transfer of which to its territory may be authorised without its prior consent. Such lists of firearms shall be communicated to dealers who have obtained approval for transferring firearms without prior authorisation under the procedure laid down in paragraph 3. Article 17 1. If the procedure provided for in Article 16 is not used, the possession of a firearm during a journey through two or more Member States shall not be permitted unless the person concerned has obtained the authorisation of each of those Member States. Member States may grant such authorisation for one or more journeys for a maximum period of one year, subject to renewal. Such authorisations shall be entered on the European firearms pass, which the traveller shall produce whenever so required by the authorities of the Member States. 2. Notwithstanding paragraph 1, hunters and historical re-enactors, in respect of firearms classified in category C, and target shooters, in respect of firearms classified in category B or C and of firearms classified in category A for which an authorisation has been granted under Article 9(6) or for which the authorisation has been confirmed, renewed or prolonged under Article 10(5), may, without the prior authorisation referred to in Article 16(2), be in possession of one or more firearms during a journey through two or more Member States with a view to engaging in their activities, provided that: (a) they are in possession of a European firearms pass listing such firearm or firearms; and (b) they are able to substantiate the reasons for their journey, in particular by producing an invitation for, or other proof of, their hunting, target shooting or historical re-enactment activities in the Member State of destination. Member States may not make acceptance of a European firearms pass conditional upon the payment of any fee or charge. However, the derogation referred to in the first subparagraph of this paragraph shall not apply to journeys to a Member State that, pursuant to Article 11(3), either prohibits the acquisition and possession of the firearm in question or makes it subject to authorisation. In that case, an express statement to that effect shall be entered on the European firearms pass. Member States may also refuse the application of this derogation in the case of firearms classified in category A for which an authorisation has been granted under Article 9(6) or for which the authorisation has been confirmed, renewed or prolonged under Article 10(5). In the context of the report referred to in Article 24, the Commission, in consultation with the Member States, shall also consider the effects of applying the third subparagraph, particularly as regards its impact on public order and public security. 3. Under agreements for the mutual recognition of national documents, two or more Member States may provide for arrangements that are more flexible than those prescribed in this Article for movement with firearms within their territories. Article 18 1. Each Member State shall communicate all useful information at its disposal concerning definitive transfers of firearms to the Member State to the territory of which such a transfer has been effected. 2. All information that Member States receive by way of the procedures laid down in Article 16 for transfers of firearms, and in Article 10(2) and Article 11(2) for the acquisition and possession of firearms by non-residents, shall be communicated, not later than at the time of the relevant transfers, to the Member States of destination and, where appropriate, not later than at the time of transfer to the Member States of transit. 3. For the purposes of the efficient application of this Directive, Member States shall exchange information on a regular basis within the contact group established by Article 13(3) of Directive 91/477/EEC. Member States shall inform each other and the Commission of the national authorities responsible for transmitting and receiving information and for complying with the obligations set out in Article 16(4) of this Directive. 4. The competent authorities of the Member States shall exchange, by electronic means, information on the authorisations granted for the transfer of firearms to another Member State and information with regard to refusals to grant authorisations, as provided for in Articles 9 and 10, on grounds of security or relating to the reliability of the person concerned. 5. The Commission shall provide for a system for the exchange of information referred to in this Article. The Commission shall adopt delegated acts in accordance with Article 19 in order to supplement this Directive by laying down the detailed arrangements for the systematic exchange of information by electronic means. Article 19 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 18(5) shall be conferred on the Commission for an indeterminate period of time from 13 June 2017. 3. The delegation of power referred to in Article 18(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 18(5) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 20 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 21 Member States shall adopt all relevant provisions prohibiting entry into their territory: (a) of a firearm, except in the cases referred to in Articles 16 and 17 and provided that the conditions laid down in those Articles are met; (b) of a weapon other than a firearm, provided that the national provisions of the Member State in question so permit. CHAPTER 4 FINAL PROVISIONS Article 22 1. Member States shall intensify controls on the possession of weapons at the external borders of the Union. They shall in particular ensure that travellers from third countries who intend to proceed to another Member State comply with Article 17. 2. This Directive shall not preclude the carrying out of controls by Member States or by the carrier at the time of boarding of a means of transport. 3. Member States shall inform the Commission of the manner in which the controls referred to in paragraphs 1 and 2 are carried out. The Commission shall collate that information and make it available to all Member States. 4. Member States shall notify the Commission of their national provisions, including changes relating to the acquisition and possession of weapons, where the national law is more stringent than the minimum standard they are required to adopt. The Commission shall pass on such information to the other Member States. Article 23 Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Article 24 By 14 September 2020, and every five years thereafter, the Commission shall submit to the European Parliament and to the Council a report on the application of this Directive, including a fitness check of its provisions, accompanied, if appropriate, by legislative proposals concerning, in particular, the categories of firearms in Annex I and issues related to the implementation of the system for the European firearms pass, to marking and to the impacts of new technologies such as 3D printing, the use of QR code and the use of radio-frequency identification (RFID). Article 25 Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive. Article 26 Directive 91/477/EEC, as amended by the Directives listed in Part A of Annex III to this Directive, is repealed, without prejudice to the obligations of the Member States relating to the time limits for the transposition into national law of the Directives set out in Part B of Annex III to this Directive. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV to this Directive. Article 27 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 28 This Directive is addressed to the Member States. Done at Brussels, 24 March 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 311, 18.9.2020, p. 52. (2) Position of the European Parliament of 9 February 2021 (not yet published in the Official Journal) and decision of the Council of 9 March 2021. (3) Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons (OJ L 256, 13.9.1991, p. 51). (4) See Annex III, Part A. (5) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (6) Council Decision 2014/164/EU of 11 February 2014 on the conclusion, on behalf of the European Union, of the Protocol against the Illicit Manufacturing of and Trafficking in Firearms, Their Parts and Components and Ammunition, supplementing the United Nations Convention against Transnational Organized Crime (OJ L 89, 25.3.2014, p. 7). (7) Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC (\u2018the IMI Regulation\u2019) (OJ L 316, 14.11.2012, p. 1). (8) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (9) Council Framework Decision 2009/315/JHA of 26 February 2009 on the organisation and content of the exchange of information extracted from the criminal record between Member States (OJ L 93, 7.4.2009, p. 23). (10) OJ L 123, 12.5.2016, p. 1. (11) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (12) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (13) OJ L 176, 10.7.1999, p. 36. (14) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (15) OJ L 53, 27.2.2008, p. 52. (16) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (17) OJ L 160, 18.6.2011, p. 21. (18) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (19) Directive 2009/43/EC of the European Parliament and of the Council of 6 May 2009 simplifying terms and conditions of transfers of defence-related products within the Community (OJ L 146, 10.6.2009, p. 1). (20) Commission Implementing Regulation (EU) 2015/2403 of 15 December 2015 establishing common guidelines on deactivation standards and techniques for ensuring that deactivated firearms are rendered irreversibly inoperable (OJ L 333, 19.12.2015, p. 62). ANNEX I I. For the purposes of this Directive, \u2018weapon\u2019 means: \u2014 any firearm as defined in Article 1, \u2014 weapons other than firearms as defined in national legislation. II. For the purposes of this Directive, firearms are classified in the following categories: Category A \u2013 Prohibited firearms 1. Explosive military missiles and launchers. 2. Automatic firearms. 3. Firearms disguised as other objects. 4. Ammunition with penetrating, explosive or incendiary projectiles, and the projectiles for such ammunition. 5. Pistol and revolver ammunition with expanding projectiles and the projectiles for such ammunition, except in the case of weapons for hunting or for target shooting, for persons entitled to use them. 6. Automatic firearms which have been converted into semi-automatic firearms, without prejudice to Article 10(5). 7. Any of the following centre-fire semi-automatic firearms: (a) short firearms which allow the firing of more than 21 rounds without reloading, if: (i) a loading device with a capacity exceeding 20 rounds is part of that firearm; or (ii) a detachable loading device with a capacity exceeding 20 rounds is inserted into it; (b) long firearms which allow the firing of more than 11 rounds without reloading, if: (i) a loading device with a capacity exceeding 10 rounds is part of that firearm; or (ii) a detachable loading device with a capacity exceeding 10 rounds is inserted into it. 8. Semi-automatic long firearms, that is to say firearms that are originally intended to be fired from the shoulder, that can be reduced to a length of less than 60 cm without losing functionality by means of a folding or telescoping stock or by a stock that can be removed without using tools. 9. Any firearm in this category that has been converted to firing blanks, irritants, other active substances or pyrotechnic rounds, or into a salute or acoustic weapon. Category B \u2013 Firearms subject to authorisation 1. Repeating short firearms. 2. Single-shot short firearms with centre-fire percussion. 3. Single-shot short firearms with rimfire percussion the overall length of which is less than 28 cm. 4. Semi-automatic long firearms the loading device and chamber of which can together hold more than three rounds in the case of rimfire firearms, and more than three but fewer than twelve rounds in the case of centre-fire firearms. 5. Semi-automatic short firearms other than those listed under point 7(a) of category A. 6. Semi-automatic long firearms listed under point 7(b) of category A the loading device and chamber of which cannot together hold more than three rounds, where the loading device is detachable or where it is not certain that the weapon cannot be converted, with ordinary tools, into a weapon the loading device and chamber of which can together hold more than three rounds. 7. Repeating and semi-automatic long firearms with smooth-bore barrels not exceeding 60 cm in length. 8. Any firearm in this category that has been converted to firing blanks, irritants, other active substances or pyrotechnic rounds, or into a salute or acoustic weapon. 9. Semi-automatic firearms for civilian use which resemble weapons with automatic mechanisms other than those listed under point 6, 7 or 8 of category A. Category C \u2013 Firearms and weapons subject to declaration 1. Repeating long firearms other than those listed in point 7 of category B. 2. Long firearms with single-shot rifled barrels. 3. Semi-automatic long firearms other than those listed in category A or B. 4. Single-shot short firearms with rimfire percussion the overall length of which is not less than 28 cm. 5. Any firearm in this category that has been converted to firing blanks, irritants, other active substances or pyrotechnic rounds, or into a salute or acoustic weapon. 6. Firearms classified in category A or B or this category that have been deactivated in accordance with Implementing Regulation (EU) 2015/2403. 7. Single-shot long firearms with smooth-bore barrels placed on the market on or after 14 September 2018. III. For the purposes of this Annex, objects which correspond to the definition of \u2018firearm\u2019 shall not be included in that definition if they: (a) are designed for alarm, signalling, life-saving, animal slaughter or harpoon fishing or for industrial or technical purposes provided that they can be used for the stated purpose only; (b) are regarded as antique weapons where such weapons have not been included in the categories set out in Part II and are subject to national laws. Pending coordination throughout the Union, Member States may apply their national laws to the firearms listed in this Part. IV. For the purposes of this Annex: (a) \u2018short firearm\u2019 means a firearm with a barrel not exceeding 30 centimetres or whose overall length does not exceed 60 centimetres; (b) \u2018long firearm\u2019 means any firearm other than a short firearm; (c) \u2018automatic firearm\u2019 means a firearm which reloads automatically each time a round is fired and can fire more than one round with one pull on the trigger; (d) \u2018semi-automatic firearm\u2019 means a firearm which reloads automatically each time a round is fired and can fire only one round with one pull on the trigger; (e) \u2018repeating firearm\u2019 means a firearm which, after a round has been fired, is designed to be reloaded from a magazine or cylinder by means of a manually-operated action; (f) \u2018single-shot firearm\u2019 means a firearm with no magazine which is loaded before each shot by the manual insertion of a round into the chamber or a loading recess at the breech of the barrel; (g) \u2018ammunition with penetrating projectiles\u2019 means ammunition for military use where the projectile is jacketed and has a penetrating hard core; (h) \u2018ammunition with explosive projectiles\u2019 means ammunition for military use where the projectile contains a charge which explodes on impact; (i) \u2018ammunition with incendiary projectiles\u2019 means ammunition for military use where the projectile contains a chemical mixture which bursts into flame on contact with the air or on impact. ANNEX II EUROPEAN FIREARMS PASS The pass shall include the following sections: (a) identity of the holder; (b) identification of the weapon or firearm, including a reference to the category within the meaning of this Directive; (c) period of validity of the pass; (d) section for use by the Member State issuing the pass (type and references of authorisations, etc.); (e) section for entries by other Member States (authorisations to enter their territory, etc.); (f) the statements: \u2018The right to travel to another Member State with one or more of the firearms classified in category A, B or C mentioned in this pass shall be subject to one or more prior corresponding authorisations from the Member State visited. Such authorisations may be recorded on the pass. The prior authorisation referred to above is not in principle necessary in order to travel with a firearm classified in category C with a view to engaging in hunting or historical re-enactment activities or with a firearm classified in category A, B or C for the purpose of taking part in target shooting, on condition that the traveller is in possession of the firearms pass and can establish the reason for the journey.\u2019 Where a Member State has informed the other Member States, in accordance with Article 11(3), that the possession of certain firearms classified in category B or C is prohibited or subject to authorisation, one of the following statements shall be added: \u2018A journey to \u2026 (State(s) concerned) with the firearm \u2026 (identification) shall be prohibited.\u2019 \u2018A journey to \u2026 (State(s) concerned) with the firearm \u2026 (identification) shall be subject to authorisation.\u2019 ANNEX III PART A Repealed Directive with list of the successive amendments thereto (referred to in Article 26) Council Directive 91/477/EEC (OJ L 256, 13.9.1991, p. 51) Directive 2008/51/EC of the European Parliament and of the Council (OJ L 179, 8.7.2008, p. 5) Directive (EU) 2017/853 of the European Parliament and of the Council (OJ L 137, 24.5.2017, p. 22) PART B Time limits for transposition into national law (referred to in Article 26) Directive Time limit for transposition 91/477/EEC 31 December 1992 2008/51/EC 28 July 2010 (EU) 2017/853 14 September 2018 (1) (1) However, under Article 2(2) of Directive (EU) 2017/853, \u2018By way of derogation from paragraph 1 of this Article, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 4(3) and Article 4(4) of Directive 91/477/EEC, as amended by this Directive, by 14 December 2019\u2019. ANNEX IV CORRELATION TABLE Directive 91/477/EEC This Directive Article 1 Article 1 Article 2 Article 2 Article 3 Article 3 Article 4(1) and (2) Article 4(1) and (2) Article 4(2a) Article 4(3) Article 4(3) Article 4(4) Article 4(4) Article 4(5) Article 4(5) Article 4(6) Article 4a Article 5 Article 5 Article 6 Article 5a Article 7 Article 5b Article 8 Article 6 Article 9 Article 7(1) to (4) Article 10(1) to (4) Article 7(4a) Article 10(5) Article 7(5) Article 10(6) Article 8(1), first subparagraph Article 11(1), first subparagraph Article 8(1), second subparagraph \u2013 \u2013 Article 11(1), second subparagraph Article 8(2) and (3) Article 11(2) and (3) Article 9(1), introductory wording Article 12(1), introductory wording Article 9(1), first indent Article 12(1) point (a) Article 9(1), second indent Article 12(1) point (b) Article 9(2) Article 12(2) Article 10 Article 13 Article 10a Article 14 Article 10b Article 15 Article 11(1) Article 16(1) Article 11(2), first subparagraph, introductory wording Article 16(2), first subparagraph, introductory wording Article 11(2), first subparagraph, first indent Article 16(2), first subparagraph, point (a) Article 11(2), first subparagraph, second indent Article 16(2), first subparagraph, point (b) Article 11(2), first subparagraph, third indent Article 16(2), first subparagraph, point (c) Article 11(2), first subparagraph, fourth indent Article 16(2), first subparagraph, point (d) Article 11(2), first subparagraph, fifth indent Article 16(2), first subparagraph, point (e) Article 11(2), first subparagraph, sixth indent Article 16(2), first subparagraph, point (f) Article 11(2), second, third and fourth subparagraph Article 16(2), second, third and fourth subparagraph Article 11(3) and (4) Article 16(3) and (4) Article 12 Article 17 Article 13 Article 18 Article 13a Article 19 Article 13b Article 20 Article 14, introductory wording Article 21, introductory wording Article 14, first indent Article 21, point (a) Article 14, second indent Article 21, point (b) Article 15 Article 22 Article 16 Article 23 Article 17 Article 24 Article 18 \u2013 \u2013 Articles 25, 26 and 27 Article 19 Article 28 Annex I Annex I Annex II Annex II \u2013 Annex III \u2013 Annex IV", "summary": "Controls on weapons purchases and possession Controls on weapons purchases and possession SUMMARY OF: Directive (EU) 2021/555 on control of the acquisition and possession of weapons WHAT IS THE AIM OF THE DIRECTIVE? It sets common minimum standards on the acquisition, possession, and commercial exchange of civilian firearms (e.g. firearms used for sport shooting and hunting) within the European Union (EU). This helps to balance internal market objectives (i.e. the cross-border movement of firearms) and security policy objectives (i.e. the high level of security and protection against criminal acts and illicit trafficking) within the EU. The directive codifies and repeals Directive 91/477/EEC (and its subsequent amendments). KEY POINTS The directive sets outs the categories of weapons whose acquisition and possession by private individuals will have to be either: prohibited (category A); or subject to authorisation (category B); or subject to declaration (category C). Where firearms have been legally acquired and possessed in accordance with the directive, national rules on carrying, hunting or shooting should apply. Marking and registration EU Member States must: ensure that all firearms manufactured in or imported into the EU on or after 14 September 2018 bear a clear, permanent and unique marking and are registered in Member States\u2019 data-filing systems; carry out strict checks on the activities of dealers and brokers; set up a computerised, centralised or decentralised data filing system, guaranteeing authorised access to the data-filing systems; ensure that data relating to firearms, including related personal data (governed by Regulation (EU) 2016/679 \u2014 see summary), are kept by the competent authorities in the data-filing system for a period of 30 years after the destruction of the firearms or essential components in question. Implementing Directive (EU) 2019/68, establishes technical specifications for the marking of firearms and their essential components under Council Directive 91/477/EEC on control of the acquisition and possession of weapons. Tracing Arms dealers and brokers must keep a register including: a record of all entries and exits in relation to each firearm; data enabling the identification and tracing of the firearm. Arms dealers and brokers based in a Member State must report transactions involving firearms to the competent national authorities without undue delay. Acquisition and possession of weapons Member States may only permit the acquisition and possession of firearms by persons who have been issued with a licence or, for category C firearms, by persons who are specifically allowed to acquire or possess such firearms in accordance with national law. Acquisition and possession of firearms is only permitted for persons who: have a valid reason and who have reached the age of 18 (except for hunting and sport shooting where parental authorisation is required); orare not likely to present a danger to themselves or others, public order or public safety. Member States may grant category A authorisations to marksmen and sportsmen for some prohibited semi-automatic firearms, as well as to recognised museums and, in exceptional and duly substantiated cases, to collectors, in accordance with strict security measures. Authorisations must be reviewed at least every 5 years. Deactivation The directive includes deactivated firearms because of the high risk of reactivating those improperly deactivated firearms. Deactivated firearms are classified in category C. The deactivation of firearms must be checked by a competent authority. Implementing Regulation (EU) 2015/2403 establishes common guidelines on deactivation standards and techniques for ensuring that deactivated firearms are rendered irreversibly inoperable. Converted weapons Because of the high risk of conversion into lethal firearms, the directive also applies to: salute and acoustic weapons (firearms specifically converted for the sole use of firing blanks, irritants, other active substances or pyrotechnic rounds); alarm and signal weapons (weapons which are designed to fire only blanks, irritants, other active substances or pyrotechnic signalling rounds, but which may be converted into real firearms). Implementing Directive (EU) 2019/69 lays down technical specifications for alarm and signal weapons. Semi-automatic weapons Firearms designed for military use, such as the AK47 and the M16, which may be manually adjusted between automatic and semi-automatic firing modes, are classified as category-A firearms and therefore banned for civilian use. Certain semi-automatic firearms are now also classified in category A: semi-automatic short firearms than can hold more than 20 rounds; semi-automatic long firearms that can hold more than 10 rounds; semi-automatic long firearms that can be reduced to a length of less than 60 cm without losing functionality by means of a folding or telescoping stock. Exchange of information The firearms directive also requires the Commission to adopt delegated acts on setting up an electronic system to exchange information between Member States. Delegated Regulation (EU) 2019/686 lays down the detailed arrangements for the systematic exchange, by electronic means, of information relating to the transfer of firearms within the EU. Delegated Regulation (EU) 2021/1423 lays down the detailed arrangements for the systematic exchange, by electronic means, of information relating to refusals to grant authorisations to acquire or possess certain firearms. Cross-border transfer A person wishing to transfer a firearm from one Member State to another may be granted a licence by the country in which the weapon is located. Target shooters and other persons authorised to possess a firearm may request a European firearms pass when travelling with their weapon to another Member State. The European firearms pass should be valid for a maximum of 5 years, which could be extended. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 26 April 2021. BACKGROUND The Protocol against the Illicit Manufacturing of and Trafficking of Firearms, their Parts and Components and Ammunition is attached to Council Decision 2014/164/EU. For more information, see: Firearms directive (European Commission). MAIN DOCUMENT Directive (EU) 2021/555 of the European Parliament and of the Council of 24 March 2021 on control of the acquisition and possession of weapons (codification) (OJ L 115, 6.4.2021, pp. 1-25) RELATED DOCUMENTS Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) Successive amendments to Regulation (EU) 2016/679 have been incorporated into the original text. This consolidated version is of documentary value only. Council Decision 2014/164/EU of 11 February 2014 on the conclusion, on behalf of the European Union, of the Protocol against the Illicit Manufacturing of and Trafficking in Firearms, Their Parts and Components and Ammunition, supplementing the United Nations Convention against Transnational Organized Crime (OJ L 89, 25.3.2014, pp. 7-9) last update 23.09.2021"}
{"article": "25.7.2019 EN Official Journal of the European Union L 198/64 REGULATION (EU) 2019/1239 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 establishing a European Maritime Single Window environment and repealing Directive 2010/65/EU THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Directive 2010/65/EU of the European Parliament and of the Council (3) requires Member States to accept the fulfilment of the reporting obligations of ships arriving in and departing from Union ports in electronic format and to ensure their transmission via a single window in order to facilitate and expedite maritime transport. (2) Maritime transport is the backbone of trade and communications within and beyond the single market. For the facilitation of maritime transport, and in order to further reduce the administrative burden for shipping companies, the information procedures for fulfilment of reporting obligations imposed on shipping companies by Union legal acts, by international legal acts and by national law of Member States should be further simplified and harmonised and should be technology-neutral, promoting future-proof reporting solutions. (3) Both the European Parliament and the Council have frequently called for more interoperability and for more comprehensive, user-friendly communication and information flows, in order to improve the functioning of the internal market and to meet the needs of citizens and businesses. (4) The main aim of this Regulation is to lay down harmonised rules for the provision of the information that is required for port calls, in particular by ensuring that the same data sets can be reported to each maritime National Single Window in the same way. This Regulation also aims to facilitate the transmission of information between declarants, relevant authorities and the providers of port services in the port of call, and other Member States. The application of this Regulation should not alter the time frames for, or the substance of, reporting obligations, and should not affect the subsequent storage and processing of information at Union level or at national level. (5) The existing maritime National Single Window in each Member State should be maintained as the basis for a technologically neutral and interoperable European Maritime Single Window environment (\u2018EMSWe\u2019). The maritime National Single Window should constitute a comprehensive reporting entry point for maritime transport operators, performing the functionalities of data collection from the declarants and data distribution to all relevant competent authorities and providers of port services. (6) In order to enhance the efficiency of the maritime National Single Windows and to prepare for future developments, it should be possible to maintain present or establish new arrangements in Member States to use the maritime National Single Window for the reporting of similar information for other transport modes. (7) The front-end interfaces of those maritime National Single Windows on the side of the declarants should be harmonised at Union level, in order to facilitate reporting and further reduce administrative burden. This harmonisation should be achieved by the use in every maritime National Single Window of common interface software for system-to-system exchanges of information, developed at Union level. The Member States should bear the responsibility for integrating and managing the interface module and for updating the software regularly and in a timely manner when new versions are provided by the Commission. The Commission should develop this module and provide updates when needed, since the development of digital technologies is moving fast and any technological solution could rapidly become outdated in the light of new developments. (8) Other reporting channels provided by Member States and service providers, such as Port Community Systems, could be maintained as optional entry points for reporting and should be able to act as data service providers. (9) In order not to impose a disproportionate administrative burden on landlocked Member States which do not have maritime ports, such Member States should be exempted from the obligation to develop, establish, operate and make available a maritime National Single Window. This means that, for as long as they make use of this exemption, such Member States should not be required to fulfil obligations that are linked to the development, establishment, operation and making available of a maritime National Single Window. (10) An easy-to-use graphical user interface with common functionalities should be part of the maritime National Single Windows for manual reporting by declarants. Member States should offer the graphical user interface for manual entry of data by declarants also by way of uploading harmonised digital spreadsheets. In addition to ensuring common functionalities, the Commission and Member States should coordinate efforts with the aim of ensuring that the user experience of those graphical user interfaces is as similar as possible. (11) Emerging new digital technologies present ever-growing opportunities to increase the efficiency of the maritime transport sector and to reduce administrative burdens. In order for the benefits of such new technologies to accrue as early as possible, the Commission should be empowered to amend the technical specifications, standards and procedures of the harmonised reporting environment by means of implementing acts. This should leave flexibility for market players to develop new digital technologies and new technologies should also be taken into account when this Regulation is reviewed. (12) Adequate support and information on the processes and technical requirements related to the use of maritime National Single Window should be provided to declarants via easily accessible and user-friendly national websites with common \u2018look and feel\u2019 standards. (13) The Convention on Facilitation of International Maritime Traffic (\u2018the FAL Convention\u2019) (4) provides that public authorities must in all cases require only essential reporting information and keep the number of items to a minimum. However, local conditions may require specific information to ensure safety of navigation. (14) In order to enable the functioning of the EMSWe, it is necessary to establish a comprehensive EMSWe data set which should cover all information elements that might be requested by national authorities or port operators for administrative or operational purposes when a ship makes a port call. When establishing the EMSWe data set, the Commission should take into account relevant work carried out at international level. Since the scope of reporting obligations varies from one Member State to another, a maritime National Single Window in a given Member State should be designed to accept the EMSWe data set without any modification, and disregard any information not relevant for that Member State. (15) In exceptional circumstances, a Member State should be able to request additional data elements from declarants. Such exceptional circumstances may arise, for example, when there is an urgent need to protect internal order and security or to address a serious threat against human or animal health or against the environment. The notion of exceptional circumstances should be interpreted strictly. (16) The relevant reporting obligations contained in the Union and international legal acts should be listed in the Annex to this Regulation. Those reporting obligations should provide the basis for the establishment of the comprehensive EMSWe data set. The Annex should also refer to the relevant categories of reporting obligations at national level, and the Member States should be able to request the Commission to amend the EMSWe data set on the basis of reporting obligations contained in their national legislation and requirements. Union legal acts which amend the EMSWe data set on the basis of a reporting obligation contained in the national legislation and requirements should include explicit reference to that national legislation and requirements. (17) Whenever the information from the maritime National Single Window is distributed to the competent authorities, the transmission should comply with the common data requirements, formats and codes for the reporting obligations and formalities provided for in the Union legal acts listed in the Annex and should be made through the IT systems established therein, such as the electronic data-processing techniques referred to in Article 6(1) of Regulation (EU) No 952/2013 of the European Parliament and of the Council (5). (18) The implementation of this Regulation should take into account the SafeSeaNet systems established at national and Union level, which should continue to facilitate the exchange and distribution of information received through the maritime National Single Window between the Member States in accordance with Directive 2002/59/EC of the European Parliament and of the Council (6). (19) Ports are not the final destination of goods. The efficiency of the ship port calls have an impact on the entire logistics chain related to the transport of goods and passengers to and from the ports. In order to ensure the interoperability, multimodality, and smooth integration of maritime transport with the overall logistics chain, and in order to facilitate other transport modes, the maritime National Single Windows should allow for the possibility of exchanging relevant information, such as arrival and departure times, with similar frameworks developed for other transport modes. (20) In order to improve the efficiency of maritime transport and to limit the duplication of the information which must be provided for operational purposes when a ship makes a port call, the information provided by declarants to a maritime National Single Window should be also shared with certain other entities, such as port or terminal operators, when authorised by the declarant, and taking into account the need to respect confidentiality, commercial sensitivities and legal constraints. This Regulation aims to improve the handling of data following the once-only principle when fulfilling the reporting obligations. (21) Regulation (EU) No 952/2013 provides that goods which are brought into the customs territory of the Union must be covered by an entry summary declaration that must be submitted to the customs authorities electronically. Given the importance of the entry summary declaration information for the management of security and financial risks, a specific electronic system is currently being developed for the submission and management of entry summary declarations in the Union customs territory. It will not, therefore, be possible to submit entry summary declarations through the harmonised reporting interface module. However, considering that some of the data elements submitted in the entry summary declaration are also required for the fulfilment of other customs and maritime reporting obligations when a ship calls in a port of the Union, the EMSWe should be able to process the data elements of the entry summary declaration. The possibility that the maritime National Single Window could retrieve relevant information that has already been submitted through the entry summary declaration should also be envisaged. (22) In order to fully harmonise reporting requirements, customs, maritime and other relevant authorities should cooperate at both national and Union level. National coordinators with specific responsibilities should enhance the effectiveness of this cooperation and the smooth functioning of the maritime National Single Windows. (23) In order to enable the reuse of the information provided through the maritime National Single Windows and facilitate the submission of information by declarants, it is necessary to provide for common databases. An EMSWe ship database should be established which includes a reference list of ship particulars and their reporting exemptions, as reported to the respective maritime National Single Window. To facilitate the submission of information by declarants, a Common Location Database should be established which holds a reference list of location codes, including the United Nations Code for Trade and Transport Locations (UN/LOCODE), the SafeSeaNet-specific codes, and the port facility codes as registered in the Global Integrated Shipping Information System (GISIS) of the International Maritime Organization (IMO). Furthermore, a Common Hazmat Database should be established which incorporates a list of dangerous and polluting goods that are to be notified to the maritime National Single Window in accordance with Directive 2002/59/EC and IMO FAL 7, taking into consideration the relevant data elements from the IMO Conventions and Codes. (24) The processing of personal data within the framework of this Regulation by competent authorities should comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (7). The processing of personal data by the Commission within the framework of this Regulation should comply with Regulation (EU) 2018/1725 of the European Parliament and of the Council (8). (25) The EMSWe and the maritime National Single Windows should not provide any other grounds for any processing of personal data than what is required for their functioning and should not be used to grant any new access rights to personal data. (26) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of supplementing this Regulation by establishing and amending the EMSWe data set and by determining definitions, categories and data specifications for the data elements, and in respect of amending the Annex to incorporate reporting obligations existing at national level as well as to take into account any new reporting obligations adopted by the Union legal acts. The Commission should ensure that the common data requirements, formats and codes established in the Union and international legal acts listed in the Annex are respected. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (9). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (27) When preparing delegated acts, the Commission should ensure that Member States\u2019 experts and the business community are consulted in a transparent manner, and well in advance. (28) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (10). (29) In particular, implementing powers should be conferred on the Commission to lay down the functional and technical specifications, quality control mechanisms and procedures for deploying, maintaining and employing the harmonised interface module and the related harmonised elements of the maritime National Single Windows. Implementing powers should also be conferred on the Commission to lay down the technical specifications, standards and procedures for common services of the EMSWe. (30) This Regulation should build on Regulation (EU) No 910/2014 of the European Parliament and of the Council (11) which lays down conditions under which Member States recognise certain means of electronic identification for natural and legal persons falling under a notified electronic identification scheme of another Member State. Regulation (EU) No 910/2014 establishes the conditions for users to be able to use their electronic identification and authentication means in order to access online public services in cross-border situations. (31) The Commission should carry out an evaluation of this Regulation. Information should be collected in order to inform that evaluation and allow the assessment of the performance of this Regulation against the objectives it pursues. The Commission should also evaluate, among other options, the added value of establishing a centralised and harmonised European reporting system, such as a central reporting interface. (32) Directive 2010/65/EU should therefore be repealed, with effect from the date of the application of this Regulation. (33) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (12), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope This Regulation establishes a framework for a technologically neutral and interoperable European Maritime Single Window environment (\u2018EMSWe\u2019) with harmonised interfaces, in order to facilitate the electronic transmission of information in relation to reporting obligations for ships arriving at, staying in and departing from a Union port. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018European Maritime Single Window environment\u2019 (\u2018EMSWe\u2019) means the legal and technical framework for the electronic transmission of information in relation to reporting obligations for port calls in the Union, which consists of a network of maritime National Single Windows with harmonised reporting interfaces and includes data exchanges via SafeSeaNet and other relevant systems as well as common services for user registry and access management, addressing, ship identification, location codes and information on dangerous and polluting goods and on health; (2) \u2018ship\u2019 means any seagoing vessel or craft operating in the marine environment that is subject to a particular reporting obligation listed in the Annex; (3) \u2018maritime National Single Window\u2019 means a nationally established and operated technical platform for receiving, exchanging and forwarding electronically information to fulfil reporting obligations, which includes commonly defined management of access rights, a harmonised reporting interface module and a graphical user interface for communication with declarants, as well as links with the relevant authorities\u2019 systems and databases at national and at Union level, which enables messages or acknowledgements covering the widest range of decisions taken by all of the participating relevant authorities to be communicated to declarants, and which could also allow, where applicable, for the connection with other reporting means; (4) \u2018harmonised reporting interface module\u2019 means a middleware component of the maritime National Single Window through which information can be exchanged between the information system used by the declarant and the relevant maritime National Single Window; (5) \u2018reporting obligation\u2019 means the information required by the Union and international legal acts listed in the Annex, as well as by the national legislation and requirements referred to in the Annex which has to be provided in connection with a port call; (6) \u2018port call\u2019 means the arrival of a ship at, the stay of a ship in, and the departure of a ship from a maritime port in a Member State; (7) \u2018data element\u2019 means the smallest unit of information which has a unique definition and precise technical characteristics such as format, length and character type; (8) \u2018EMSWe data set\u2019 means the complete list of data elements stemming from reporting obligations; (9) \u2018graphical user interface\u2019 means a web interface for two-way web-based user-to-system data submission to a maritime National Single Window, allowing declarants to enter data manually, inter alia, by means of harmonised digital spreadsheets and functions that enable reporting data elements to be extracted from those spreadsheets, as well as including common functionalities and features that ensure a common navigation flow and data upload experience for the declarants; (10) \u2018common addressing service\u2019 means an additional voluntary service for declarants for initiating direct system-to-system data connections between the system of a declarant and the harmonised reporting interface module of the respective maritime National Single Window; (11) \u2018declarant\u2019 means any natural or legal person who is subject to reporting obligations or any duly authorised natural or legal person acting on that person\u2019s behalf within the limits of the relevant reporting obligation; (12) \u2018customs authorities\u2019 means the authorities defined in point (1) of Article 5 of Regulation (EU) No 952/2013; (13) \u2018data service provider\u2019 means a natural or legal person who provides information and communication technology services to a declarant in relation to reporting obligations; (14) \u2018electronic transmission of information\u2019 means the process of transmitting information that has been encoded digitally, using a revisable structured format which can be used directly for data storage and processing by computers; (15) \u2018provider of port services\u2019 means any natural or legal person who provides one or more categories of the port services listed in Article 1(2) of Regulation (EU) 2017/352 of the European Parliament and of the Council (13). CHAPTER II EMSWe DATA SET Article 3 Establishment of the EMSWe data set 1. The Commission shall establish and amend the EMSWe data set pursuant to paragraph 3 of this Article. 2. By 15 February 2020, the Member States shall notify the Commission of any reporting obligations stemming from national legislation and requirements, as well as of the data elements to be included in the EMSWe data set. They shall precisely identify those data elements. 3. The Commission is empowered to adopt delegated acts in accordance with Article 23 in order to amend the Annex to this Regulation for the purpose of introducing, deleting or adapting references to national legislation or requirements, Union or international legal acts, and in order to establish and amend the EMSWe data set. The first such delegated act shall be adopted by 15 August 2021. As set out in Article 4, a Member State may request the Commission to introduce or amend data elements in the EMSWe data set, in accordance with the reporting obligations contained in the national legislation and requirements. When assessing whether data elements are to be included in the EMSWe data set, the Commission shall take into account safety concerns, as well as the principles of the FAL Convention, namely the principle of only requiring the reporting of essential information and keeping the number of items to a minimum. The Commission shall decide, within three months after the request, whether to introduce the data elements in the EMSWe data set. The Commission shall justify its decision. A delegated act which introduces or amends a data element in the EMSWe data set shall include an explicit reference to the national legislation and requirements referred to in the third subparagraph. In the event that the Commission decides not to introduce the requested data element, the Commission shall give substantiated grounds for its refusal, with reference to the safety of navigation and the principles of the FAL Convention. Article 4 Amendments to the EMSWe data set 1. Where a Member State intends to amend a reporting obligation under in its national legislation and requirements which would involve the provision of information other than the information that is included in the EMSWe data set, that Member State shall immediately notify the Commission. In that notification, the Member State shall precisely identify the information that is not covered by the EMSWe data set and shall indicate the intended period during which the reporting obligation in question is to apply. 2. A Member State shall not introduce new reporting obligations unless such introduction has been approved by the Commission through the procedure set out in Article 3 and the corresponding information has been incorporated in the EMSWe data set and applied in the harmonised reporting interfaces. 3. The Commission shall assess the necessity of amending the EMSWe data set in accordance with Article 3(3). Amendments to the EMSWe data set shall only be introduced once a year, except in duly justified cases. 4. In exceptional circumstances, a Member State may ask declarants to provide additional data elements without the approval of the Commission during a period of less than three months. The Member State shall notify those data elements to the Commission without delay. The Commission may allow the Member State to continue to request the additional data elements for two further periods of three months if the exceptional circumstances persist. No later than one month before the end of the last three-month period referred to in the first subparagraph, the Member State may request the Commission that the additional data elements become part of the EMSWe data set, in accordance with Article 3(3). The Member State may continue to ask declarants to provide the additional data elements until a decision by the Commission has been taken, and in the event of a positive decision, until the amended EMSWe data set has been implemented. CHAPTER III PROVISION OF INFORMATION Article 5 Maritime National Single Window 1. Each Member State shall establish a maritime National Single Window through which, in accordance with this Regulation and without prejudice to Articles 7 and 11, all information necessary for the fulfilment of reporting obligations shall be provided once, by means of and in compliance with the EMSWe data set, using the harmonised reporting interface module and the graphical user interface as set out in Article 6 and, where applicable, other reporting means as set out in Article 7, for the purpose of making this information available to the relevant authorities of the Member States to the extent necessary to allow those authorities to perform their respective functions. Member States shall be responsible for the operation of their maritime National Single Window. Member States may jointly establish a maritime single window with one or more other Member States. Those Member States shall designate that maritime single window as their maritime National Single Window, and shall remain responsible for its operation in accordance with this Regulation. 2. Member States which do not have maritime ports shall be exempted from the obligation to develop, establish, operate and make available a maritime National Single Window which is set out in paragraph 1. 3. The Member States shall ensure: (a) the compatibility of the maritime National Single Window with the harmonised reporting interface module and adherence of the graphical user interface of their maritime National Single Window to the common functionalities in accordance with Article 6(2); (b) the timely integration of the harmonised reporting interfaces in accordance with the implementation dates set in the implementing act referred to in Article 6 and any subsequent updates in accordance with the dates agreed in the Multi-annual Implementation Plan (MIP); (c) a connection with the relevant systems of competent authorities, to enable the transfer of data to be reported to those authorities, through the maritime National Single Window, and to those systems, in accordance with Union legal acts and national legislation and requirements, and in compliance with the technical specifications of those systems; (d) the provision of a helpdesk during the first 12 months from 15 August 2025 and an online support website for their maritime National Single Window with clear instructions in the official language(s) of that Member State and, where relevant, in a language that is internationally used; (e) the provision of adequate and necessary training for staff who are directly involved in the operation of the maritime National Single Window. 4. Member States shall ensure that the required information reaches the authorities in charge of the application of the legislation in question, and is limited to the needs of each of those authorities. In doing so, Member States shall ensure compliance with the legal requirements related to the transmission of information, provided for in the Union legal acts listed in the Annex and, where applicable, use the electronic data-processing techniques referred to in Article 6(1) of Regulation (EU) No 952/2013. Member States shall also ensure interoperability with the information systems used by those authorities. 5. The maritime National Single Window shall provide the technical possibility for declarants to make available, separately, to providers of port services at the port of destination a subset of data elements pre-defined at national level. 6. Where a Member State does not require all of the elements of the EMSWe data set for the fulfilment of reporting obligations, the maritime National Single Window shall accept submissions that are limited to the data elements that are required by that Member State. The maritime National Single Window shall also accept submissions by declarants that include additional elements of the EMSWe data set; however, it does not need to process and store those additional elements. 7. Member States shall store the information submitted to their respective maritime National Single Windows only for the period of time necessary to ensure the fulfilment of the requirements set out in this Regulation and to ensure compliance with the Union, international and national legal acts listed in the Annex. Member States shall immediately delete such information thereafter. 8. Member States shall make publicly available estimated and actual arrival and departure times of ships in an electronic format harmonised at Union level, on the basis of the data submitted by declarants to the maritime National Single Window. This obligation shall not apply to ships carrying sensitive cargo, where the publication of such information by the maritime National Single Window could pose a threat to security. 9. The maritime National Single Windows shall have a uniform internet address. 10. The Commission shall adopt implementing acts laying down a harmonised structure for the support website referred to in point (d) of paragraph 3, technical specifications for making available arrival and departure times referred to in paragraph 8, and a uniform format for internet addresses referred to in paragraph 9. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 6 Harmonised Reporting Interfaces 1. The Commission shall, in close cooperation with the Member States, adopt implementing acts laying down the functional and technical specifications for the harmonised reporting interface module for the maritime National Single Windows. The functional and technical specifications shall aim to facilitate the interoperability with different technologies and reporting systems of the users. The first such implementing act shall be adopted by 15 August 2021. 2. The Commission shall, in close cooperation with the Member States, develop by 15 August 2022 and thereafter update the harmonised reporting interface module for the maritime National Single Windows in conformity with the specifications referred to in paragraphs 1 and 5 of this Article. 3. The Commission shall provide the Member States with the harmonised reporting interface module and all relevant information for the integration into their maritime National Single Window. 4. The Commission shall adopt implementing acts laying down the common functionalities of the graphical user interface and the templates of the harmonised digital spreadsheets referred to in Article 2(9). The first such implementing act shall be adopted by 15 August 2021. 5. The Commission shall adopt implementing acts amending the technical specifications, standards and procedures, in order to ensure that the harmonised reporting interfaces are open to future technologies. 6. The implementing acts referred to in this Article shall be adopted in accordance with the advisory procedure referred to in Article 24(2). Article 7 Other means of reporting 1. Member States shall allow declarants to provide, on a voluntary basis, information to the maritime National Single Window through data service providers that comply with the requirements of the harmonised reporting interface module. 2. Member States may allow declarants to provide the information through other reporting channels provided that those channels are voluntary for the declarants. In such cases, Member States shall ensure that those other channels make the relevant information available to the maritime National Single Window. 3. Member States may use alternative means for the provision of information in the event of a temporary failure of any of the electronic systems referred to in Articles 5 and 6 and Articles 12 to 17. Article 8 Once-only principle 1. Without prejudice to Article 11(1), unless otherwise required by Union law, Member States shall ensure that the declarant is requested to provide the information pursuant to this Regulation only once per port call, and that the relevant data elements of the EMSWe data set are made available and reused in accordance with paragraph 3 of this Article. 2. The Commission shall ensure that the ship identification information, particulars and exemptions that are provided through the maritime National Single Window are recorded in the EMSWe ship database referred to in Article 14 and are made available for any subsequent port calls within the Union. 3. Member States shall ensure that the data elements of the EMSWe data set provided at departure from a port in the Union are made available to the declarant for the purpose of fulfilling the reporting obligations at arrival to the next port in the Union, provided that the ship has not called at a port outside of the Union during that voyage. This paragraph shall not apply to information received pursuant to Regulation (EU) No 952/2013, unless the possibility of making such information available for such purpose is provided for in that Regulation. 4. Any relevant data elements of the EMSWe data set received in accordance with this Regulation shall be made available to other maritime National Single Windows via the SafeSeaNet. 5. The Commission shall adopt implementing acts laying down the list of relevant data elements referred to in paragraphs 3 and 4 of this Article. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). Article 9 Responsibility for the information communicated The declarant shall be responsible for ensuring the submission of data elements in compliance with the applicable legal and technical requirements. The declarant shall remain responsible for the data and for updating any information that has changed after the submission to the maritime National Single Window. Article 10 Data protection and confidentiality 1. The processing of personal data by competent authorities within the framework of this Regulation shall comply with Regulation (EU) 2016/679. 2. The processing of personal data by the Commission within the framework of this Regulation shall comply with Regulation (EU) 2018/1725. 3. Member States and the Commission shall take the necessary measures in accordance with the applicable Union or national law to ensure the confidentiality of commercial and other sensitive information exchanged pursuant to this Regulation. Article 11 Additional provisions for customs 1. This Regulation shall not prevent the exchange of information between customs authorities of the Member States, or between customs authorities and economic operators, using the electronic data-processing techniques referred to in Article 6(1) of Regulation (EU) No 952/2013. 2. The relevant information in the Entry Summary Declaration referred to in Article 127 of Regulation (EU) No 952/2013, where compatible with Union customs law, shall be made available to the maritime National Single Window for reference and, where appropriate, reused for other reporting obligations listed in the Annex. 3. The Commission shall adopt implementing acts laying down the list of relevant information referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. CHAPTER IV COMMON SERVICES Article 12 EMSWe user registry and access management system 1. The Commission shall establish and ensure the availability of a common user registry and access management system for declarants and data service providers that use the maritime National Single Window, as well as for national authorities that access the maritime National Single Window in cases where authentication is required. That common user registry and access management system shall provide for a single user registration by means of an existing Union registry with Union level recognition, federated user management and Union level user monitoring. 2. Each Member State shall designate a national authority to be responsible for the identification and registration of new users and the modification and termination of existing accounts through the system referred to in paragraph 1. 3. For the purpose of access to the maritime National Single Window in different Member States, a declarant or data service provider that is registered in the EMSWe user registry and access management system shall be considered to be registered with the maritime National Single Window in all Member States, and shall operate within the limits of the access rights granted by each Member State in accordance with its national rules. 4. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for setting up the common user registry and access management system referred to in paragraph 1, including the functionalities referred to in paragraph 2. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 13 Common addressing service 1. The Commission shall develop, in close cooperation with the Member States, an additional voluntary common addressing service, provided that the harmonised reporting interface module has been implemented fully in accordance with Article 6. 2. The Commission, in close cooperation with the Member States, shall adopt implementing acts laying down the functional and technical specifications, quality control mechanisms and procedures for deploying, maintaining and employing the common addressing service. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2024. Article 14 EMSWe Ship Database 1. In accordance with Article 8(2), the Commission shall establish a EMSWe ship database containing a list of ship identification information and particulars, as well as records on ship reporting exemptions. 2. Member States shall ensure the provision of the data referred to in paragraph 1 to the EMSWe ship database on the basis of the data submitted by declarants to the maritime National Single Window. 3. The Commission shall ensure the availability of the ship database data to the maritime National Single Windows for facilitation of ship reporting. 4. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for the setting up of the database referred to in paragraph 1 with respect to the collecting, storing, updating and provision of the ship identification information and particulars, as well as records on ship reporting exemptions. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 15 Common Location Database 1. The Commission shall establish a common location database that contains a reference list of location codes (14) and port facility codes, as registered in the IMO database GISIS. 2. The Commission shall ensure the availability of the location database to the maritime National Single Windows in order to facilitate ship reporting. 3. Member States shall make information from the location database available at national level through the maritime National Single Window. 4. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for the setting up of the common location database referred to in paragraph 1 with respect to collecting, storing, updating and provision of the location and port facility codes. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 16 Common Hazmat Database 1. The Commission shall establish a common hazmat database containing a list of dangerous and polluting goods which are to be notified in accordance with Directive 2002/59/EC and IMO FAL 7, taking into consideration the relevant data elements from the IMO Conventions and Codes. 2. The Commission shall ensure the availability of the common hazmat database to the maritime National Single Windows to facilitate ship reporting. 3. The database shall be linked to the relevant entries in the MAR-CIS database developed by European Maritime Safety Agency (EMSA) regarding information on associated hazards and risks of dangerous and polluting goods. 4. The database shall be used both as a reference and a verification tool, at national and Union level, during the reporting process through the maritime National Single Window. 5. Member States shall make information from the common hazmat database available at national level through the maritime National Single Window. 6. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for the setting up of the common hazmat database referred to in paragraph 1 with respect to the collecting, storing and provision of the hazmat reference information. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 17 Common Ship Sanitation Database 1. The Commission shall make available a common ship sanitation database that is able to receive and store data related to the Maritime Declarations of Health under Article 37 of the International Health Regulations 2005 (IHR). Personal data relating to ill persons on board ships shall not be stored on that database. The competent health authorities of the Member States shall have access to the database for the purpose of receiving and exchanging data. 2. Member States that use the ship sanitation database shall make known to the Commission their national authority responsible for user management in relation to that database, including the registration of new users as well as the modification and closure of accounts. 3. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for the setting up of the database referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). CHAPTER V COORDINATION OF THE EMSWe ACTIVITIES Article 18 National coordinators Each Member State shall designate a competent national authority with a clear legal mandate to act as a national coordinator for the EMSWe. The national coordinator shall: (a) act as the national contact point for users and the Commission for all matters relating to the implementation of this Regulation; (b) coordinate the application of this Regulation by the competent national authorities within a Member State and their cooperation; (c) coordinate the activities aiming at ensuring the distribution of data and the connection with the relevant systems of competent authorities as referred in point (c) of Article 5(3). Article 19 Multi-annual Implementation Plan In order to facilitate the timely implementation of this Regulation and to provide quality control mechanisms and procedures for deploying, maintaining and updating the harmonised interface module and the related harmonised elements of the EMSWe, the Commission shall adopt, and revise on a yearly basis, following appropriate consultations of Member States\u2019 experts, a Multi-annual Implementation Plan which shall provide: (a) a plan for the development and updating of the harmonised reporting interfaces and the related harmonised elements of the EMSWe over the following 18 months; (b) a plan for the development of the common addressing service by 15 August 2024; (c) indicative dates for consultation with relevant stakeholders; (d) indicative deadlines for the Member States for the subsequent integration of the harmonised reporting interfaces with the maritime National Single Windows; (e) indicative deadlines for the Commission\u2019s development of a common addressing service following the implementation of the harmonised reporting interface module; (f) testing periods for Member States and declarants to test their connections with any new versions of the harmonised reporting interfaces; (g) testing periods for the common addressing service; (h) indicative phasing-out deadlines for the older versions of the harmonised reporting interfaces for the Member States and declarants. CHAPTER VI FINAL PROVISIONS Article 20 Costs The general budget of the European Union shall cover the costs for: (a) the development and maintenance of the ICT tools by the Commission and EMSA supporting the implementation of this Regulation at Union level; (b) the promotion of the EMSWe at Union level, including among relevant stakeholders, and at the level of relevant international organisations. Article 21 Cooperation with other trade and transport facilitation systems or services Where trade and transport facilitation systems or services have been created by other Union legal acts, the Commission shall coordinate the activities related to those systems or services with a view to achieving synergies and avoiding duplication. Article 22 Review and report Member States shall monitor the application of the EMSWe, and report their findings to the Commission. The report shall include the following indicators: (a) use of the harmonised reporting interface module; (b) use of the graphical user interface; (c) use of other means of reporting as referred to in Article 7. Member States shall submit that report to the Commission on an annual basis, using a template to be provided by the Commission. By 15 August 2027, the Commission shall review the application of this Regulation and shall submit to the European Parliament and the Council an assessment report on the functioning of the EMSWe on the basis of the data and statistics collected. The assessment report shall include, where necessary, an evaluation of emerging technologies which could lead to changes to or the replacement of the harmonised reporting interface module. Article 23 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3 shall be conferred on the Commission for a period of four years from 14 August 2019. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the four-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period. 3. The delegation of power referred to in Article 3 may be revoked at any time by the European Parliament or the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. When adopting a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 3 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 24 Committee procedure 1. The Commission shall be assisted by a Digital Transport and Trade Facilitation Committee. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 25 Repeal of Directive 2010/65/EU Directive 2010/65/EU is repealed from 15 August 2025. References to Directive 2010/65/EU shall be construed as references to this Regulation. Article 26 Entry into force 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 15 August 2025. 3. The functionalities referred to in Article 11(2) and those related to the customs reporting obligations specified in point 7 of Part A of the Annex shall become effective when the electronic systems referred to in Article 6(1) of Regulation (EU) No 952/2013 which are necessary for the application of those reporting obligations are operational, in accordance with the work programme established by the Commission pursuant to Articles 280 and 281 of Regulation (EU) No 952/2013. The Commission shall publish the date on which the conditions of this paragraph have been fulfilled in the \u2018C\u2019 series of the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 62, 15.2.2019, p. 265. (2) Position of the European Parliament of 18 April 2019 (not yet published in the Official Journal) and decision of the Council of 13 June 2019. (3) Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting formalities for ships arriving in and/or departing from ports of the Member States and repealing Directive 2002/6/EC (OJ L 283, 29.10.2010, p. 1). (4) International Maritime Organization (IMO) Convention on Facilitation of International Maritime Traffic (the \u2018FAL Convention\u2019), adopted on 9 April 1965 and amended on 8 April 2016, Standard 1.1. (5) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (6) Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system and repealing Council Directive 93/75/EEC (OJ L 208, 5.8.2002, p. 10). (7) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (8) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (9) OJ L 123, 12.5.2016, p. 1. (10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (11) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73). (12) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (13) Regulation (EU) 2017/352 of the European Parliament and of the Council of 15 February 2017 establishing a framework for the provision of port services and common rules on the financial transparency of ports (OJ L 57, 3.3.2017, p. 1). (14) \u2018United Nations Code for Trade and Transport Locations\u2019. ANNEX REPORTING OBLIGATIONS A. Reporting obligations stemming from legal acts of the Union This category of reporting obligations includes the information which is to be provided in accordance with the following provisions: 1. Notification for ships arriving in and departing from ports of the Member States Article 4 of Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system (OJ L 208, 5.8.2002, p. 10). 2. Border checks on persons Article 8 of Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). 3. Notification of dangerous or polluting goods carried on board Article 13 of Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system (OJ L 208, 5.8.2002, p. 10). 4. Notification of waste and residues Article 6 of Directive 2000/59/EC of the European Parliament and of the Council of 27 November 2000 on port reception facilities for ship-generated waste and cargo residues (OJ L 332, 28.12.2000, p. 81). 5. Notification of security information Article 6 of Regulation (EC) No 725/2004 of the European Parliament and of the Council of 31 March 2004 on enhancing ship and port facility security (OJ L 129, 29.4.2004, p. 6). The form set out in the Appendix to this Annex shall be used for identifying the data elements required under Article 6 of Regulation (EC) No 725/2004. 6. Information on persons on board Articles 4(2) and 5(2) of Council Directive 98/41/EC of 18 June 1998 on the registration of persons sailing on board passenger ships operating to or from ports of the Member States of the Community (OJ L 188, 2.7.1998, p. 35). 7. Customs formalities (a) Arrival formalities: \u2014 Notification of arrival (Article 133 of Regulation (EU) No 952/2013); \u2014 Presentation of goods to customs (Article 139 of Regulation (EU) No 952/2013); \u2014 Temporary storage declaration of goods (Article 145 of Regulation (EU) No 952/2013); \u2014 Customs status of goods (Articles 153 to 155 of Regulation (EU) No 952/2013; \u2014 Electronic transport documents used for transit (Article 233(4)(e) of Regulation (EU) No 952/2013). (b) Departure formalities: \u2014 Customs status of goods (Articles 153 to 155 of Regulation (EU) No 952/2013); \u2014 Electronic transport documents used for transit (Article 233(4)(e) of Regulation (EU) No 952/2013); \u2014 Exit notification (Article 267 of Regulation (EU) No 952/2013); \u2014 Exit summary declaration (Articles 271 and 272 of Regulation (EU) No 952/2013); \u2014 Re-export notification (Articles 274 and 275 of Regulation (EU) No 952/2013). 8. Safe loading and unloading of bulk carriers Article 7 of Directive 2001/96/EC of the European Parliament and of the Council of 4 December 2001 establishing harmonised requirements and procedures for the safe loading and unloading of bulk carriers (OJ L 13, 16.1.2002, p. 9). 9. Port State control Article 9 and Article 24(2) of Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (OJ L 131, 28.5.2009, p. 57). 10. Maritime transport statistics Article 3 of the Directive 2009/42/EC of the European Parliament and of the Council of 6 May 2009 on statistical returns in respect of carriage of goods and passengers by sea (OJ L 141, 6.6.2009, p. 29). B. FAL documents and reporting obligations stemming from international legal instruments This category of reporting obligations includes the information which is to be provided in accordance with the FAL Convention and other relevant international legal instruments. 1. FAL 1: General Declaration 2. FAL 2: Cargo Declaration 3. FAL 3: Ship\u2019s Stores Declaration 4. FAL 4: Crew\u2019s Effects Declaration 5. FAL 5: Crew List 6. FAL 6: Passenger List 7. FAL 7: Dangerous Goods 8. Maritime Declaration of Health C. Reporting obligations stemming from national legislation and requirements APPENDIX SHIP PRE-ARRIVAL SECURITY INFORMATION FORM FOR ALL SHIPS PRIOR TO ENTRY INTO THE PORT OF AN EU MEMBER STATE (1974 International Convention for the Safety of Life at Sea (SOLAS) regulation 9 of Chapter XI-2 and Article 6(3) of Regulation (EC) No 725/2004) Text of image Particulars of the ship and contact details IMO number Name of ship Port of registry Flag State Type of ship Call Sign Gross Tonnage Inmarsat call numbers (if available) Name of Company and company identification number CSO name & 24 hour contact details Port of arrival Port facility of arrival (if known) Port and port facility information Expected date and time of arrival of the ship in port (ETA) Primary purpose of call Information required by SOLAS Regulation 9.2.1 of Chapter XI-2 Does the ship have a valid International Ship Security Certificate (ISSC)? YES ISSC NO - why not? Issued by (name of Administration or RSO) Expiry date (dd/mm/yyyy) Does the ship have an approved SSP on board? YES NO Security Level at which the ship is currently operating? Security Level 1 Security Level 2 Security Level 3 Location of ship at the time this report is made List the last ten calls at port facilities in chronological order (most recent call first): No. Date from (dd/mm/yyyy) Date to (dd/mm/yyyy) Port Country UN/LOCODE (if available) Port facility Security Level 1 SL = 2 SL = 3 SL = 4 SL = 5 SL = Text of image No. Date from (dd/mm/yyyy) Date to (dd/mm/yyyy) Port Country UN/LOCODE (if available) Port facility Security Level 6 SL = 7 SL = 8 SL = 9 SL = 10 SL = Did the ship take any special or additional security measures, beyond those in the approved SSP? If the answer is YES, indicate below the special or additional security measures taken by the ship. YES NO No. (as above) Special or additional security measures taken by the ship 1 2 3 4 5 6 7 8 9 10 List the ship-to-ship activities, in chronological order (most recent first), which were carried out during the last ten calls at port facilities listed above. Expand table below or continue on separate page if necessary \u2013 insert total number of ship-to-ship activities: Text of image Were the ship security procedures specified in the approved SSP maintained during each of these ship-to-ship activities? If NO, provide details of the security measures applied in lieu in the final column below. YES NO No. Date from (dd/mm/yyyy) Date to (dd/mm/yyyy) Location or Longitude and Latitude Ship-to-ship activity Security measures applied in lieu 1 2 3 4 5 6 7 8 9 10 General description of the cargo aboard the ship Is the ship carrying any dangerous substances as cargo covered by any of Classes 1, 2.1, 2.3, 3, 4.1, 5.1, 6.1, 6.2, 7 or 8 of the IMDG Code? YES NO If YES, confirm Dangerous Goods Manifest (or relevant extract) is attached Confirm a copy of ship\u2019s crew list is attached YES Confirm a copy of the ship\u2019s passenger list is attached YES Other security related information Is there any security-related matter you wish to report? YES Provide details: NO Agent of ship at intended port of arrival Name: Contact details (Tel. no.): Identification of person providing the information Title or Position (delete as appropriate): Master / SSO / CSO / Ship\u2019s agent (as above) Name: Signature: Date/Time/Place of completion of report", "summary": "European Maritime Single Window environment (EMSWe) European Maritime Single Window environment (EMSWe) SUMMARY OF: Regulation (EU) 2019/1239 establishing a European Maritime Single Window environment WHAT IS THE AIM OF THE REGULATION? It introduces an interoperable European Maritime Single Window environment (EMSWe) with harmonised interfaces*, to simplify reporting obligations* for ships arriving at, staying in and departing from EU ports. It aims to improve the European maritime transport sector\u2019s competitiveness and efficiency by reducing administrative burden, introducing a simplified digital information system to harmonise the existing national systems and reduce the need for paperwork. KEY POINTS The EMSWe is the legal and technical framework for the electronic transmission of information about reporting obligations for ships calling at EU ports. It is a network of maritime national single windows* with harmonised reporting interfaces and includes data exchanges using SafeSeaNet and other systems, as well as services for: user registry and access management; common addressing service; EMSWe ship database; common location database; common hazardous material (\u2018hazmat\u2019) database; and ship sanitation database. Establishing the common EMSWe data set The regulation maintains the existing maritime national single window in each EU country as the basis for a technologically neutral and interoperable EMSWe. The European Commission is empowered to adopt delegated acts to establish a new common EMSWe data set, incorporating and adapting the most relevant requirements in existing national or EU legislation. EU countries must notify the Commission of any reporting obligations and requirements stemming from national legislation and any data elements they wish to be included in the EMSWe data set. Harmonised reporting Interfaces The Commission will adopt implementing acts laying down the functional and technical specifications for the harmonised reporting interface module for the maritime national single windows, aiming for them to be interoperable with different user technologies and reporting systems. Once-only principle The Convention on Facilitation of International Maritime Traffic (FAL Convention) provides that public authorities must in all cases require only essential reporting information and keep the number of items to a minimum. Under the regulation, EU countries must ensure that ship operators are asked to provide any required information only once per port call, and that relevant supplied data are retained for reuse. Common services As components of the EMSW environment, the Commission establishes: a common access-management and user registry system for declarants and for dataservice providers and national authorities that use the maritime national single window in cases where authentication is required; an additional and optional common addressing service, provided that the harmonised reporting interface module has been fully implemented; a ship database containing a list of vessel identification information and characteristics as well as records on ship reporting exemptions; a common location database containing a reference list of location codes and port facility codes listed in the International Maritime Organization\u2019s Global Integrated Shipping Information System (GISIS) database; a common hazmat database containing a list of dangerous and polluting goods that must be notified; a common ship sanitation database that is able to receive and store data on maritime declarations of health. This does not include personal data relating to sick passengers or crew; a multiannual implementation plan, revised annually. Each EU country designates a competent national authority with a legal mandate to act as a national coordinator for the EMSWe. The regulation does not affect the exchange of information between customs authorities, or between customs authorities and businesses, using the electronic data-processing techniques referred to in Regulation (EU) No 952/2013 (see summary). Repeal Regulation (EU) 2019/1239 repeals Directive 2010/65/EU (see summary) as of 15 August 2025. FROM WHEN DOES THE REGULATION APPLY? It applies from 15 August 2025. BACKGROUND For more information, see: European Maritime Single Window environment (European Commission) European Maritime Single Window (EMSW) (European Maritime Safety Agency). KEY TERMS Harmonised reporting interface module: a middleware (software) component of the maritime national single window through which information can be exchanged between the information system used by the declarant and the relevant maritime national single window. Reporting obligation: the information required by the EU, international and national legislation and requirements (referred to in the Annex) which has to be provided in connection with a port call. Maritime national single window: a nationally established and operated technical platform for receiving, exchanging and forwarding electronically information to fulfil reporting obligations, including management of access rights, a harmonised reporting interface module and a graphical user interface (GUI), as well as links with the relevant authorities\u2019 systems and databases at national and at EU level. MAIN DOCUMENT Regulation (EU) 2019/1239 of the European Parliament and of the Council of 20 June 2019 establishing a European Maritime Single Window environment and repealing Directive 2010/65/EU (OJ L 198, 25.7.2019, pp. 64-87) RELATED DOCUMENTS Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, pp. 73-114) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (recast) (OJ L 269, 10.10.2013, pp. 1-101) Successive amendments to Regulation (EU) No 952/2013 have been incorporated into the original text. This consolidated version is of documentary value only. Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting formalities for ships arriving in and/or departing from ports of the Member States and repealing Directive 2002/6/EC (OJ L 283, 29.10.2010, pp. 1-10) See consolidated version. last update 12.01.2020"}
{"article": "29.3.2019 EN Official Journal of the European Union L 91/45 DIRECTIVE (EU) 2019/520 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 19 March 2019 on the interoperability of electronic road toll systems and facilitating cross-border exchange of information on the failure to pay road fees in the Union (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Directive 2004/52/EC of the European Parliament and of the Council (4) has been substantially amended. Since further amendments are to be made, that Directive should be recast in the interests of clarity. (2) It is desirable to achieve widespread deployment of electronic road toll systems in the Member States and in the neighbouring countries, and to have, as far as possible, reliable, user friendly, and cost-efficient systems suited to the future development of road-charging policy at Union level and to future technical developments. Therefore, it is necessary to make electronic road toll systems interoperable to reduce the cost of, and the burdens linked to, the payment of tolls across the Union. (3) Interoperable electronic road toll systems contribute to achieving the objectives laid down by Union law on road tolls. (4) The lack of interoperability is a significant problem in electronic road toll systems where the road fee due is linked to the distance covered by the vehicle (distance-based tolls) or to the vehicle passing a specific point (for example, cordon pricing). The provisions regarding the interoperability of electronic road toll systems should therefore apply only to those systems and should not apply to systems where the road fee due is linked to the time spent by the vehicle on the tolled infrastructure (for example, time-based systems such as vignettes). (5) Cross-border enforcement of the obligation to pay road fees in the Union is a significant problem in all kind of systems, whether distance-based, cordon-based or time-based, electronic or manual. To deal with the problem of cross-border enforcement following a failure to pay a road fee, the provisions regarding the cross-border exchange of information should therefore apply to all those systems. (6) In national law, the offence of failing to pay a road fee can be classified as an administrative offence or as a criminal offence. This Directive should apply regardless of the classification of the offence. (7) Due to the lack of consistent classification across the Union, and their indirect link to the use of the infrastructure, parking fees should be left outside the scope of this Directive. (8) The interoperability of electronic road toll systems requires harmonisation of the technology used and of the interfaces between interoperability constituents. (9) The harmonisation of technologies and interfaces should be supported by the development and maintenance of appropriate open and public standards, available on a non-discriminatory basis to all system suppliers. (10) For the purpose of covering, with their on-board equipment (OBE), the required communication technologies, European Electronic Toll Service (EETS) providers should be allowed to make use of, and link to, other hardware and software systems already present in the vehicle, such as satellite navigation systems or handheld devices. (11) The specific characteristics of electronic road toll systems which are currently applied to light-duty vehicles should be taken into account. Since no such electronic road toll systems currently use satellite positioning or mobile communications, EETS providers should be allowed, for a limited period of time, to provide users of light-duty vehicles with OBE suitable for use with 5,8 GHz microwave technology only. This derogation should be without prejudice to the right of Member States to implement satellite-based tolling for light-duty vehicles. (12) Toll systems based on automatic number plate recognition (ANPR) technology require more manual checks of toll transactions in the back office than systems using OBE. Systems using OBE are more efficient for large electronic toll domains, and systems using ANPR technology are more suitable for small domains, such as city tolls, where the use of OBE would generate disproportionate costs or administrative burdens. ANPR technology can be useful in particular when combined with other technologies. (13) In view of technical developments connected with solutions based on ANPR technology, the standardisation bodies should be encouraged to define the necessary technical standards. (14) The specific rights and obligations of EETS providers should apply to entities which prove that they have fulfilled certain requirements and have obtained registration as EETS providers in their Member State of establishment. (15) The rights and obligations of the main EETS actors, that is to say, the EETS providers, toll chargers and EETS users, should be clearly defined to ensure that the market functions in a fair and efficient manner. (16) It is particularly important to safeguard certain rights of the EETS providers, such as the right to the protection of commercially sensitive data, and to do so without negatively impacting the quality of the services provided to the toll chargers and EETS users. In particular, the toll charger should be required not to disclose commercially sensitive data to any of the EETS provider's competitors. The amount and type of data which EETS providers communicate to toll chargers, for the purpose of calculating and applying tolls or of verifying the calculation of applied toll on the vehicles of EETS users by the EETS providers, should be kept to a strict minimum. (17) EETS providers should be required to fully cooperate with toll chargers in their enforcement efforts, so as to increase the overall efficiency of electronic road toll systems. Therefore, toll chargers should be allowed to request from the EETS provider, where a failure to pay a road fee is suspected, data relating to the vehicle and to the owner or holder of the vehicle who is the EETS provider's client, provided that those data are not used for any purpose other than enforcement. (18) In order to enable EETS providers to compete, in a non-discriminatory manner, for all clients in a given EETS domain, it is important that the possibility is given to them to become accredited to that domain sufficiently early so that they are able to offer services to the users as of the first day of operation of the toll system. (19) Toll chargers should give access to their EETS domain to EETS providers on a non-discriminatory basis. (20) To ensure transparency and non-discriminatory access to EETS domains for all EETS providers, toll chargers should publish all the necessary information relating to access rights in an EETS domain statement. (21) All OBE user rebates or discounts on tolls offered by a Member State or by a toll charger should be transparent, publicly announced and available under the same conditions to clients of EETS providers. (22) EETS providers should be entitled to fair remuneration, calculated based on a transparent, non-discriminatory and identical methodology. (23) Toll chargers should be allowed to deduct from the remuneration of EETS providers the appropriate costs incurred to provide, operate and maintain the EETS-specific elements of the electronic road toll system. (24) EETS providers should pay to the toll charger all tolls due by their clients. EETS providers should, however, not be liable for tolls that their clients have not paid, when the latter are equipped with an OBE that has been declared to the toll charger as invalidated. (25) Where a legal entity that is a toll service provider also plays other roles in an electronic road toll system, or has other activities not directly related to electronic toll collection, it should be required to keep accounting records which make a clear distinction possible between the costs and revenues related to the provision of toll services and the costs and revenues related to other activities, and to provide, upon request, information on those costs and revenues related to the provision of toll services to the relevant Conciliation Body or judicial body. Cross subsidies between the activities performed in the role of toll service provider and other activities should not be allowed. (26) Users should have the possibility to subscribe to EETS through any EETS provider, regardless of their nationality, Member State of residence or Member State of registration of the vehicle. (27) To avoid double payment and to give users legal certainty, the payment of a toll to an EETS provider should be considered as fulfilling the user's obligations towards the relevant toll charger. (28) The contractual relationships between toll chargers and EETS providers should ensure, inter alia, that tolls are paid correctly. (29) A mediation procedure should be established with a view to settling disputes between toll chargers and EETS providers during contractual negotiations and in their contractual relationships. National Conciliation Bodies should be consulted by toll chargers and EETS providers who are seeking a settlement of a dispute relating to the right to non-discriminatory access to EETS domains. (30) Conciliation Bodies should have the power to verify that the contractual conditions imposed on any EETS provider are non-discriminatory. In particular, they should have the power to verify that the remuneration offered by the toll charger to the EETS providers respects the principles set out in this Directive. (31) The traffic data of EETS users constitutes input that is essential for enhancing transport policies of the Member States. Member States should therefore have the possibility to request such data from toll service providers, including EETS providers for the purpose of designing traffic policies and enhancing traffic management or for other non-commercial use by the State, in compliance with applicable data protection rules. (32) A framework is needed that lays down the procedures for accrediting EETS providers to an EETS domain and that ensures fair access to the market while safeguarding the adequate level of service. The EETS domain statement should set out in detail the procedure for accrediting an EETS provider to the EETS domain, and in particular the procedure for checking conformity to specifications and suitability for use of interoperability constituents. The procedure should be the same for all EETS providers. (33) To ensure easy access to information by EETS market actors, Member States should be required to compile and publish all important data regarding EETS in publicly available national registers. (34) To allow for technological progress, it is important that toll chargers have the possibility to test new tolling technologies or concepts. Such tests should however be limited, and EETS providers should not be required to take part in them. The Commission should have the possibility of not authorising such tests if they could prejudice the correct functioning of the regular electronic road toll system or of the EETS. (35) Large differences in technical specifications of electronic road toll systems might hamper the achievement of EU-wide interoperability of electronic tolls, and thus contribute to the persistence of the current situation where users need several pieces of OBE to pay tolls in the Union. This situation is detrimental to the efficiency of transport operations, to the cost-efficiency of toll systems, and to the achievement of transport policy objectives. The issues underlying this situation should therefore be addressed. (36) While cross-border interoperability is improving throughout the Union, the mid- to long-term objective is to make it possible to travel across the Union with only one piece of OBE. Therefore, in order to avoid administrative burdens and costs for road users, it is important that the Commission set up a roadmap to achieve this objective, and to facilitate the free movement of people and goods in the Union, without negatively affecting competition on the market. (37) The EETS is a market-based service and therefore EETS providers should not be obliged to provide their services across the Union. However, in the interest of users, EETS providers should cover all EETS domains in any Member State in which they decide to provide their services. Furthermore, the Commission should assess whether the flexibility given to EETS providers leads to the exclusion from EETS of small or peripheral EETS domains, and, if it finds that it does, take action where necessary. (38) The EETS domain statement should describe in detail the framework commercial conditions for EETS providers' operations in the EETS domain in question. In particular, it should describe the methodology used for calculating the remuneration of EETS providers. (39) Where a new electronic road toll system is being launched or an existing system is being substantially modified, the toll charger should publish the new or updated EETS domain statements with sufficient notice to allow EETS providers to be accredited or re-accredited to the system at the latest one month before the day of its operational launch. The toll charger should design and follow the procedure for the accreditation or, respectively, re-accreditation of EETS providers in such a way that the procedure can be concluded at the latest one month before the operational launch of the new or substantially modified system. Toll chargers should respect their part of the planned procedure as defined in the EETS domain statement. (40) Toll chargers should not request or require from EETS providers any specific technical solutions which could jeopardise interoperability with other EETS domains and with the existing interoperability constituents of the EETS provider. (41) The EETS has the potential to considerably reduce the administrative costs and burdens of international road transport operators and drivers. (42) EETS providers should be allowed to issue invoices to EETS users. However, toll chargers should be allowed to request that invoices are sent on their behalf and in their name, since invoicing directly in the name of the EETS provider can, in certain EETS domains, have adverse administrative and tax implications. (43) Each Member State with at least two EETS domains should designate a contact office for EETS providers wishing to provide the EETS in its territory in order to facilitate their contacts with the toll chargers. (44) Electronic tolling and other services, such as cooperative ITS (C-ITS) applications use similar technologies and neighbouring frequency bands for short range vehicle-to-vehicle and vehicle-to-infrastructure communication. In the future, the potential for applying other emerging technologies to electronic tolling merits exploration, after a thorough assessment of the costs, benefits, technical barriers and possible solutions thereto. It is important that measures are implemented to protect existing investments in the 5,8 GHz microwave technology from the interference of other technologies. (45) Without prejudice to State aid and competition law, Member States should be allowed to develop measures to promote electronic toll collection and billing. (46) When standards relevant for the EETS are reviewed by the standardisation bodies, there should be appropriate transition arrangements to ensure the continuity of the EETS and the compatibility, with the toll systems, of interoperability constituents already in use at the moment of the revision of the standards. (47) The EETS should allow intermodality to develop, whilst pursuing compliance with the \u2018user pays\u2019 and \u2018polluter pays\u2019 principles. (48) Problems with identifying non-resident offenders to electronic road toll systems hamper further deployment of such systems and the wider application of the \u2018user pays\u2019 and \u2018polluter pays\u2019 principles on Union roads and therefore there is a need to find a way to identify such persons and to process their personal data. (49) For reasons of consistency and efficient use of resources, the system for exchanging information on those who fail to pay a road fee, and on their vehicles, should use the same tools as the system that is used for exchanging information on road-safety-related traffic offences provided for in Directive (EU) 2015/413 of the European Parliament and of the Council (5). (50) In certain Member States a failure to pay a road fee is established only once the obligation to pay the road fee has been notified to the user. Since this Directive does not harmonise national laws in this regard, Member States should have the possibility to apply this Directive to identify users and vehicles for the purpose of notification. However, such extended application should be allowed only if certain conditions are fulfilled. (51) Follow-up proceedings initiated after a failure to pay a road fee are not harmonised across the Union. Often, the identified road user is given the possibility of paying the road fee due, or a fixed substitute amount, directly to the entity responsible for levying the road fee, before any further administrative or criminal proceedings are initiated by Member State authorities. It is important that such efficient procedure to put an end to the failure to pay a road fee is available on similar terms to all road users. For this purpose, Member States should be allowed to provide the entity responsible for levying the road fee with the data necessary to identify the vehicle in respect of which there was a failure to pay a road fee and to identify its owner or holder, provided that proper protection of personal data is ensured. In this context, Member States should ensure that compliance with the payment order issued by the entity concerned puts an end to the failure to pay a road fee. (52) In certain Member States, the absence, or dysfunctioning, of OBE is regarded as a failure to pay a road fee where such fees can only be paid by using OBE. (53) Member States should provide the Commission with the information and data necessary to evaluate the effectiveness and efficiency of the system for exchanging information on those who fail to pay a road fee. The Commission should assess the data and information obtained, and propose, if necessary, amendments to this Directive. (54) While analysing possible measures to further facilitate the cross-border enforcement of the obligation to pay road fees in the Union, the Commission should also assess in its report the need for mutual assistance between Member States. (55) The enforcement of the obligation to pay road fees, the identification of the vehicle and of the owner or holder of the vehicle for which a failure to pay a road fee was established and the collection of information on the user for the purpose of ensuring the compliance of the toll charger with its obligations to tax authorities all entail the processing of personal data. Such processing needs to be carried out in accordance with Union rules, as set out, inter alia, in Regulation (EU) 2016/679 of the European Parliament and of the Council (6), Directive (EU) 2016/680 of the European Parliament and of the Council (7) and Directive 2002/58/EC of the European Parliament and of the Council (8). The right to protection of personal data is explicitly recognised by Article 8 of the Charter of Fundamental Rights of the European Union. (56) This Directive does not affect the Member States' freedom to lay down rules governing road infrastructure charging and taxation matters. (57) In order to facilitate the cross-border exchange of information on the vehicles and owners or holders of vehicles for which there was a failure to pay road fees, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of the amendment of Annex I to reflect changes in the Union law. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission also in respect of laying down the details for the classification of vehicles for the purposes of establishing the applicable tariff schemes, further defining the obligations of the EETS users regarding the provision of data to the EETS provider and the use and handling of the OBE, laying down the requirements for interoperability constituents regarding safety and health, reliability and availability, environment protection, technical compatibility, security and privacy and operation and management, laying down the general infrastructure requirements for interoperability constituents and laying down the minimum criteria of eligibility for notified bodies. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (9). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (58) The implementation of this Directive requires uniform conditions for the application of technical and administrative specifications for the deployment, in the Member States, of procedures that involve EETS actors and the interfaces between them, so as to facilitate interoperability and ensure that national toll collection markets are governed by equivalent rules. In order to ensure uniform conditions for the implementation of this Directive and to define those technical and administrative specifications, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (10). (59) This Directive should be without prejudice to the obligations of the Member States relating to the time-limit for the transposition into national law of the Directive set out in Annex III, Part B. (60) This Directive respects the fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union, notably the protection of personal data. (61) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (11), HAVE ADOPTED THIS DIRECTIVE: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Directive lays down the conditions necessary for the following purposes: (a) to ensure the interoperability of electronic road toll systems on the entire Union road network, urban and interurban motorways, major and minor roads, and various structures, such as tunnels or bridges, and ferries; and (b) to facilitate the cross-border exchange of vehicle registration data regarding the vehicles and the owners or holders of vehicles for which there was a failure to pay road fees of any kind in the Union. In order to respect the principle of subsidiarity, this Directive shall apply without prejudice to the decisions taken by Member States to levy road fees on particular types of vehicles, and to determine the level of those fees and the purpose for which such fees are levied. 2. Articles 3 to 22 do not apply to: (a) road toll systems which are not electronic within the meaning of point 10 of Article 2; and (b) small, strictly local road toll systems for which the costs of compliance with the requirements of Articles 3 to 22 would be disproportionate to the benefits. 3. This Directive does not apply to parking fees. 4. The objective of the interoperability of electronic road toll systems in the Union shall be achieved by means of the European Electronic Toll Service (EETS) which shall be complementary to the national electronic toll services of the Member States. 5. Where the national law requires a notification to the user of the obligation to pay before a failure to pay a road fee can be established, Member States may also apply this Directive to identify the owner or the holder of the vehicle and the vehicle itself for notification purposes, only if all the following conditions are fulfilled: (a) there are no other means to identify the owner or holder of the vehicle; and (b) the notification to the owner or holder of the vehicle of the obligation to pay is a compulsory stage of the road fee payment procedure under national law. 6. Where a Member State applies paragraph 5, it shall take the measures necessary to ensure that any follow-up proceedings in relation to the obligation to pay the road fee are pursued by public authorities. References to failure to pay a road fee in this Directive shall include cases covered by paragraph 5 if the Member State where the failure to pay takes place, applies that paragraph. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: (1) \u2018toll service\u2019 means the service that enables users to use a vehicle in one or more EETS domains under a single contract and, where necessary, with one piece of on-board equipment (OBE), and which includes: (a) where necessary, providing a customised OBE to users and maintaining its functionality; (b) guaranteeing that the toll charger is paid the toll due by the user; (c) providing to the user the means by which the payment is to be made or accepting an existing one; (d) collecting the toll from the user; (e) managing customer relations with the user; and (f) implementing and adhering to the security and privacy policies for the road toll systems; (2) \u2018toll service provider\u2019 means a legal entity providing toll services on one or more EETS domains for one or more classes of vehicles; (3) \u2018toll charger\u2019 means a public or private entity which levies tolls for the circulation of vehicles in an EETS domain; (4) \u2018designated toll charger\u2019 means a public or private entity which has been appointed as the toll charger in a future EETS domain; (5) \u2018European Electronic Toll Service (EETS)\u2019 means the toll service provided under a contract on one or more EETS domains by an EETS provider to an EETS user; (6) \u2018EETS provider\u2019 means an entity which, under a separate contract, grants access to EETS to an EETS user, transfers the tolls to the relevant toll charger, and which is registered by its Member State of establishment; (7) \u2018EETS user\u2019 means a natural or legal person who has a contract with an EETS provider in order to have access to the EETS; (8) \u2018EETS domain\u2019 means a road, a road network, a structure, such as a bridge or a tunnel, or a ferry, where tolls are collected using an electronic road toll system; (9) \u2018EETS compliant system\u2019 means the set of elements of an electronic road toll system which are specifically needed for the integration of EETS providers in the system and for the operation of EETS; (10) \u2018electronic road toll system\u2019 means a toll collection system in which the obligation, for the user, to pay the toll is exclusively triggered by and linked to the automatic detection of the presence of the vehicle in a certain location through remote communication with OBE in the vehicle or automatic number plate recognition; (11) \u2018on-board equipment (OBE)\u2019, means the complete set of hardware and software components to be used as part of the toll service which is installed or carried on board a vehicle in order to collect, store, process and remotely receive/transmit data, either as a separate device or embedded in the vehicle; (12) \u2018main service provider\u2019 means a toll service provider with specific obligations, such as the obligation to sign contracts with all interested users, or specific rights, such as specific remuneration or a guaranteed long term contract, different from the rights and obligations of other service providers; (13) \u2018interoperability constituent\u2019 means any elementary component, group of components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into EETS upon which the interoperability of the service depends directly or indirectly, including both tangible objects and intangible objects such as software; (14) \u2018suitability for use\u2019 means the ability of an interoperability constituent to achieve and maintain a specified performance when in service, integrated representatively into EETS in relation with a toll charger's system; (15) \u2018toll context data\u2019 means the information defined by the responsible toll charger as necessary to establish the toll due for circulating a vehicle on a particular toll domain and conclude the toll transaction; (16) \u2018toll declaration\u2019 means a statement to a toll charger that confirms the presence of a vehicle in an EETS domain in a format agreed between the toll service provider and the toll charger; (17) \u2018vehicle classification parameters\u2019 means the vehicle related information in accordance with which tolls are calculated based on the toll context data; (18) \u2018back office\u2019 means the central electronic system used by the toll charger, a group of toll chargers who have created an interoperability hub, or by the EETS provider to collect, process and send information in the framework of an electronic road toll system; (19) \u2018substantially modified system\u2019 means an existing electronic road toll system that has undergone or undergoes a change which requires EETS providers to make modifications to the interoperability constituents that are in operation, such as reprogramming or adapting the interfaces of their back office, to such an extent that re-accreditation is required; (20) \u2018accreditation\u2019 means the process defined and managed by the toll charger, which an EETS provider must undergo before it is authorised to provide the EETS in an EETS domain; (21) \u2018toll\u2019 or \u2018road fee\u2019 means the fee which must be paid by the road user for circulating on a given road, a road network, a structure, such as a bridge or a tunnel, or a ferry; (22) \u2018failure to pay a road fee\u2019 means the offence consisting of the failure by a road user to pay a road fee in a Member State, defined by the relevant national provisions of that Member State; (23) \u2018Member State of registration\u2019 means the Member State where the vehicle which is subject to the payment of the road fee is registered; (24) \u2018national contact point\u2019 means a designated competent authority of a Member State for the cross-border exchange of vehicle registration data; (25) \u2018automated search\u2019 means an online access procedure for consulting the databases of one, more than one, or all of the Member States; (26) \u2018vehicle\u2019 means a motor vehicle, or articulated vehicle combination intended or used for the carriage by road of passengers or goods; (27) \u2018holder of the vehicle\u2019 means the person in whose name the vehicle is registered, as defined in the law of the Member State of registration; (28) \u2018heavy-duty vehicle\u2019 means a vehicle having a maximum permissible mass exceeding 3,5 tonnes; (29) \u2018light-duty vehicle\u2019 means a vehicle having a maximum permissible mass not exceeding 3,5 tonnes. Article 3 Technological solutions 1. All new electronic road toll systems which require the installation or use of OBE shall, for carrying out electronic toll transactions, use one or more of the following technologies: (a) satellite positioning; (b) mobile communications; (c) 5,8 GHz microwave technology. Existing electronic road toll systems which require the installation or use of OBE and use other technologies shall comply with the requirements set out in the first subparagraph of this paragraph if substantial technological improvements are carried out. 2. The Commission shall request the relevant standardisation bodies, in accordance with the procedure laid down by Directive (EU) 2015/1535 of the European Parliament and of the Council (12) to swiftly adopt standards applicable to electronic road toll systems with regard to the technologies listed in the first subparagraph of paragraph 1 and the ANPR technology, and to update them where necessary. The Commission shall request that the standardisation bodies ensure the continual compatibility of interoperability constituents. 3. OBE which uses satellite positioning technology and is placed on the market after 19 October 2021 shall be compatible with the positioning services provided by the Galileo and the European Geostationary Navigation Overlay Service (\u2018EGNOS\u2019) systems. 4. Without prejudice to paragraph 6, EETS providers shall make available to EETS users OBE which is suitable for use, interoperable and capable of communicating with the relevant electronic road toll systems in service in the Member States using the technologies listed in the first subparagraph of paragraph 1. 5. The OBE may use its own hardware and software, use elements of other hardware and software present in the vehicle, or both. For the purpose of communicating with other hardware systems present in the vehicle, the OBE may use technologies other than those listed in the first subparagraph of paragraph 1, provided that security, quality of service and privacy are ensured. EETS OBE is allowed to facilitate services other than tolling, provided that the operation of such services does not interfere with the toll services in any EETS domain. 6. Without prejudice to the right of Member States to introduce electronic road toll systems for light-duty vehicles based on satellite positioning or mobile communications, EETS providers may until 31 December 2027 provide users of light-duty vehicles with OBE suitable for use with 5,8 GHz microwave technology only, to be used in EETS domains which do not require satellite positioning or mobile communications technologies. CHAPTER II GENERAL PRINCIPLES OF EETS Article 4 Registration of EETS providers Each Member State shall establish a procedure for registering EETS providers. It shall grant the registration to entities which are established on its territory, which request registration and which can demonstrate that they fulfil the following requirements: (a) hold EN ISO 9001 certification or equivalent; (b) have the technical equipment and the EC declaration or certificate attesting the conformity of the interoperability constituents to specifications; (c) have competence in the provision of electronic toll services or in other relevant domains; (d) have appropriate financial standing; (e) maintain a global risk management plan, which is audited at least every two years; and (f) are of good repute. Article 5 Rights and obligations of EETS providers 1. Member States shall take the measures necessary to ensure that EETS providers whom they have registered conclude EETS contracts covering all EETS domains on the territories of at least four Member States within the 36 months following their registration in accordance with Article 4. They shall take the measures necessary to ensure that that those EETS providers conclude contracts covering all EETS domains in a given Member State within the 24 months following the conclusion of the first contract in that Member State, except for those EETS domains in which the responsible toll chargers do not comply with Article 6(3). 2. Member States shall take the measures necessary to ensure that EETS providers whom they have registered maintain at all times the coverage of all EETS domains once they have concluded contracts therefor. They shall take the measures necessary to ensure that, where an EETS provider is not able to maintain coverage of an EETS domain because the toll charger does not comply with this Directive, it re-establishes the coverage of the concerned domain as soon as possible. 3. Member States shall take the measures necessary to ensure that EETS providers whom they have registered publish information on their EETS domains coverage and any changes thereto, as well as, within one month of registration, detailed plans regarding any extension of their service to further EETS domains, with annual updates. 4. Member States shall take the measures necessary to ensure that, where necessary, EETS providers whom they have registered, or who provide the EETS on their territory, provide EETS users with OBE which fulfils the requirements set out in this Directive, as well as in Directives 2014/53/EU (13) and 2014/30/EU (14) of the European Parliament and of the Council. They may request from concerned EETS providers evidence that those requirements are fulfilled. 5. Member States shall take the measures necessary to ensure that EETS providers who provide the EETS on their territory keep lists of invalidated OBE related to their EETS contracts with the EETS users. They shall take the measures necessary to ensure that such lists are maintained in strict compliance with the Union rules on the protection of personal data as set out, inter alia, in Regulation (EU) 2016/679 and Directive 2002/58/EC. 6. Member States shall take the measures necessary to ensure that EETS providers whom they registered make public their contracting policy towards EETS users. 7. Member States shall take the measures necessary to ensure that EETS providers who provide the EETS on their territory provide toll chargers with the information they need to calculate and apply the toll on the vehicles of EETS users or provide toll chargers with all information necessary to allow them to verify the calculation of applied toll on the vehicles of EETS users by the EETS providers. 8. Member States shall take the measures necessary to ensure that EETS providers who provide the EETS on their territory cooperate with toll chargers in their efforts to identify suspected offenders. Member States shall take the measures necessary to ensure that, where a failure to pay a road fee is suspected, the toll charger is able to obtain, from the EETS provider, the data relating to the vehicle involved in the suspected failure to pay a road fee and to the owner or holder of that vehicle who is a client of the EETS provider. Such data shall be made available instantly by the EETS provider. Member States shall take the measures necessary to ensure that the toll charger does not disclose such data to any other toll service provider. They shall take the measures necessary to ensure that, where the toll charger is integrated with a toll service provider in one entity, the data are used for the sole purpose of identifying suspected offenders, or in accordance with Article 27(3). 9. Member States shall take the measures necessary to ensure that a toll charger responsible for an EETS domain on their territory is able to obtain, from an EETS provider, data relating to all vehicles owned or held by clients of the EETS provider, which have, in a given period of time, driven on the EETS domain for which the toll charger is responsible, as well as data relating to the owners or holders of these vehicles, provided that the toll charger needs this data to comply with its obligations to tax authorities. Member States shall take the measures necessary to ensure that the EETS provider provides the requested data no later than two days after receiving the request. They shall take the measures necessary to ensure that the toll charger does not disclose such data to any other toll service provider. They shall take the measures necessary to ensure that, where the toll charger is integrated with a toll service provider in one entity, the data are used for the sole purpose of compliance by the toll charger with its obligations to tax authorities. 10. The data provided by EETS providers to toll chargers shall be processed in compliance with Union rules on the protection of personal data as set out in Regulation (EU) 2016/679, as well as with the national laws, regulations or administrative provisions transposing Directives 2002/58/EC and (EU) 2016/680. 11. The Commission shall adopt implementing acts, at the latest by 19 October 2019, to further define the obligations of the EETS providers regarding: (a) monitoring the performance of their service level, and cooperation with toll chargers in verification audits; (b) cooperation with toll chargers in the performance of toll chargers' systems' tests; (c) service and technical support to EETS users and personalisation of OBE; (d) the invoicing of EETS users; (e) the information which EETS providers must provide to toll chargers and which is referred to in paragraph 7; and (f) informing the EETS user of a detected toll non-declaration situation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). Article 6 Rights and obligations of toll chargers 1. Where an EETS domain does not comply with the technical and procedural EETS interoperability conditions provided for in this Directive, the Member State on whose territory the EETS domain lies shall take the measures necessary to ensure that the responsible toll charger assesses the problem with the stakeholders concerned and, if within its sphere of responsibilities, takes remedial actions with a view to ensuring EETS interoperability of the toll system. Where necessary, the Member State shall update the register referred to in Article 21(1) in respect of the information referred to in point (a) thereof. 2. Each Member State shall take the measures necessary to ensure that any toll charger responsible for an EETS domain on the territory of that Member State develops and maintains an EETS domain statement setting out the general conditions for EETS providers for accessing their EETS domains, in accordance with the implementing acts referred to in paragraph 9. Where a new electronic road toll system is created on the territory of a Member State, that Member State shall take the measures necessary to ensure that the designated toll charger responsible for the system publishes the EETS domain statement with sufficient notice to allow for an accreditation of interested EETS providers at the latest one month before the operational launch of the new system, with due regard to the length of the process of assessment of conformity to specifications and of the suitability for use of interoperability constituents referred to in Article 15(1). Where an electronic road toll system on the territory of a Member State is substantially modified, that Member State shall take the measures necessary to ensure that the toll charger responsible for the system publishes the updated EETS domain statement with sufficient notice to allow already accredited EETS providers to adapt their interoperability constituents to the new requirements and to obtain re-accreditation at the latest one month before the operational launch of the modified system, giving due regard to the length of the process of assessment of the conformity to specifications and of the suitability for use of interoperability constituents referred to in Article 15(1). 3. Member States shall take the measures necessary to ensure that toll chargers responsible for EETS domains on their territory accept on a non-discriminatory basis any EETS provider requesting to provide EETS on the said EETS domains. Acceptance of an EETS provider in a EETS domain shall be subject to the provider's compliance with the obligations and general conditions set out in the EETS domain statement. Member States shall take the measures necessary to ensure that toll chargers do not require EETS providers to use specific technical solutions, or processes, that hinder the interoperability of an EETS provider's interoperability constituents with electronic road toll systems in other EETS domains. If a toll charger and an EETS provider cannot reach an agreement, the matter may be referred to the Conciliation Body responsible for the relevant toll domain. 4. Each Member State shall take the measures necessary to ensure that the contracts between the toll charger and the EETS provider, regarding the provision of EETS on the territory of that Member State, permit the invoice for the toll to be issued to the EETS user directly by the EETS provider. The toll charger may require that the EETS provider invoices the user in the name and on behalf of the toll charger, and the EETS provider shall comply with that request. 5. The toll charged by toll chargers to EETS users shall not exceed the corresponding national or local toll. This is without prejudice to the right of Member States to introduce rebates or discounts to promote the use of electronic toll payments. All OBE user rebates or discounts on tolls offered by a Member State or by a toll charger shall be transparent, publicly announced and available under the same conditions to clients of EETS providers. 6. Member States shall take the measures necessary to ensure that toll chargers accept on their EETS domains any operational OBE from EETS providers with whom they have contractual relationships which have been certified in accordance with the procedure defined in the implementing acts referred to in Article 15(7) and which do not appear on a list of invalidated OBE referred to in Article 5(5). 7. In the event of an EETS dysfunction attributable to the toll charger, the toll charger shall provide for a degraded mode of service enabling vehicles with the equipment referred to in paragraph 6 to circulate safely with a minimum of delay and without being suspected of a failure to pay a road fee. 8. Member States shall take the measures necessary to ensure that toll chargers collaborate in a non-discriminatory way with EETS providers or manufacturers or notified bodies with a view to assessing the suitability for use of interoperability constituents on their EETS domains. 9. The Commission shall adopt implementing acts, at the latest by 19 October 2019, to lay down the minimum content of the EETS domain statement, including: (a) the requirements for EETS providers; (b) the procedural conditions, including commercial conditions; (c) the procedure of accreditation of EETS providers; and (d) the toll context data. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). Article 7 Remuneration 1. Member States shall take the measures necessary to ensure that EETS providers are entitled to be remunerated by the toll charger. 2. Member States shall take the measures necessary to ensure that the methodology for defining the remuneration of the EETS providers is transparent, non-discriminatory and identical for all EETS providers accredited to a given EETS domain. They shall take the measures necessary to ensure that the methodology is published as part of the commercial conditions in the EETS domain statement. 3. Member States shall take the measures necessary to ensure that in EETS domains with a main service provider, the methodology for calculating the remuneration of EETS providers follows the same structure as the remuneration of comparable services provided by the main service provider. The amount of remuneration of EETS providers may differ from the remuneration of the main service provider provided that it is justified by: (a) the cost of specific requirements and obligations of the main service provider and not of the EETS providers; and (b) the need to deduct, from the remuneration of EETS providers, the fixed charges imposed by the toll charger based on the costs, for the toll charger, of providing, operating and maintaining an EETS compliant system in its toll domain, including the costs of accreditation, where such costs are not included in the toll. Article 8 Tolls 1. Member States shall take the measures necessary to ensure that where, for the purpose of establishing the toll tariff applicable to a given vehicle, there is discrepancy between the vehicle classification used by the EETS provider and the toll charger, the toll charger's classification prevails, unless an error can be demonstrated. 2. Member States shall take the measures necessary to ensure that the toll charger is entitled to require, from an EETS provider, payment for any substantiated toll declaration and any substantiated toll non-declaration relating to any EETS user account managed by that EETS provider. 3. Member States shall take the measures necessary to ensure that, where an EETS provider has sent to a toll charger a list of invalidated OBE referred to in Article 5(5), the EETS provider shall not be held liable for any further toll incurred through the use of such invalidated OBE. The number of entries in the list of invalidated OBE, the list's format and its updating frequency shall be agreed between toll chargers and EETS providers. 4. Member States shall take the measures necessary to ensure that, in microwave-based toll systems, toll chargers communicate to EETS providers substantiated toll declarations for tolls incurred by their respective EETS users. 5. The Commission shall adopt delegated acts in accordance with Article 30, at the latest by 19 October 2019, to lay down the details for the classification of vehicles for the purposes of establishing the applicable tariff schemes, including any procedures necessary for establishing such schemes. The set of vehicle classification parameters to be supported by EETS shall not restrict the choice of tariff schemes by toll chargers. The Commission shall ensure sufficient flexibility to allow the set of classification parameters to be supported by EETS to evolve according to foreseeable future needs. Those acts shall be without prejudice to the definition, in Directive 1999/62/EC of the European Parliament and of the Council (15), of the parameters according to which tolls shall vary. Article 9 Accounting Member States shall take the measures necessary to ensure that legal entities which provide toll services keep accounting records which make a clear distinction possible between the costs and revenues related to the provision of toll services and the costs and revenues related to other activities. The information on the costs and revenues related to the toll service provision shall be provided, upon request, to the relevant Conciliation Body or judicial body. Member States shall also take the measures necessary to ensure that cross subsidies between the activities performed in the role of toll service provider and other activities are not allowed. Article 10 Rights and obligations of EETS users 1. Member States shall take the measures necessary to allow EETS users to subscribe to EETS through any EETS provider, regardless of their nationality, Member State of residence or the Member State in which the vehicle is registered. When entering into a contract, EETS users shall be duly informed about valid means of payment and, in accordance with Regulation (EU) 2016/679, about the processing of their personal data and the rights stemming from applicable legislation on the protection of personal data. 2. The payment of a toll by an EETS user to its EETS provider shall be deemed to fulfil the EETS user's payment obligations to the relevant toll charger. If two or more OBE are installed or carried on-board a vehicle, it is the responsibility of the EETS user to use or activate the relevant OBE for the specific EETS domain. 3. The Commission shall adopt delegated acts in accordance with Article 30, at the latest by 19 October 2019, to further define the obligations of the EETS users regarding: (a) the provision of data to the EETS provider; and (b) the use and handling of the OBE. CHAPTER III CONCILIATION BODY Article 11 Establishment and functions 1. Each Member State with at least one EETS domain shall designate or establish a Conciliation Body in order to facilitate mediation between toll chargers with an EETS domain located within its territory and EETS providers that have contracts or are in contractual negotiations with those toll chargers. 2. The Conciliation Body shall be empowered, in particular, to verify that the contractual conditions imposed by a toll charger on EETS providers are non-discriminatory. It shall be empowered to verify that the EETS providers are remunerated in accordance with the principles provided for in Article 7. 3. The Member States referred to in paragraph 1 shall take the measures necessary to ensure that their Conciliation Body is independent, in its organisation and legal structure, from the commercial interests of toll chargers and toll service providers. Article 12 Mediation procedure 1. Each Member State with at least one EETS domain shall lay down a mediation procedure in order to enable a toll charger or an EETS provider to request the relevant Conciliation Body to intervene in any dispute relating to their contractual relations or negotiations. 2. The mediation procedure referred to in paragraph 1 shall require that the Conciliation Body states, within a period of one month following the receipt of a request for it to intervene, whether all documents necessary for the mediation are in its possession. 3. The mediation procedure referred to in paragraph 1 shall require that the Conciliation Body issues its opinion on a dispute no later than six months after receipt of the request for it to intervene. 4. In order to facilitate its tasks, Member States shall give the Conciliation Body the power to request relevant information from toll chargers, EETS providers and any third parties active in the provision of EETS within the Member State concerned. 5. The Member States with at least one EETS domain and the Commission shall take the measures necessary to ensure the exchange of information between the Conciliation Bodies concerning their work, guiding principles and practices. CHAPTER IV TECHNICAL PROVISIONS Article 13 Single continuous service Member States shall take the measures necessary to ensure that EETS is provided to EETS users as a single continuous service. This means that: (a) once the vehicle classification parameters, including the variable ones, have been stored or declared, or both, no further in-vehicle human intervention is required during a journey unless there is a modification to the vehicle's characteristics; and (b) human interaction with a particular piece of OBE stays the same whatever the EETS domain. Article 14 Additional elements regarding EETS 1. Member States shall take the measures necessary to ensure that the interaction of EETS users with toll chargers as part of EETS is limited, where applicable, to the invoicing process in accordance with Article 6(4) and to enforcement processes. Interactions between EETS users and EETS providers, or their OBE, may be specific to each EETS provider, without compromising EETS interoperability. 2. Member States may require that toll service providers, including EETS providers, at the request of the Member States authorities, provide traffic data in respect of their clients, subject to compliance with the applicable data protection rules. Such data shall only be used by the Member States for the purpose of traffic policies and enhancing traffic management and the data shall not be used to identify the clients. 3. The Commission shall adopt, at the latest by 19 October 2019, implementing acts laying down the specifications of electronic interfaces between the interoperability constituents of toll chargers, EETS providers and EETS users, including, where applicable, the content of the messages exchanged between the actors through those interfaces. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). Article 15 Interoperability constituents 1. Where a new electronic road toll system is created on the territory of a Member State, that Member State shall take the measures necessary to ensure that the designated toll charger responsible for the system establishes and publishes in the EETS domain statement the detailed planning of the process of assessment of conformity to specifications and of the suitability for use of interoperability constituents, which allows for the accreditation of interested EETS providers at the latest one month before the operational launch of the new system. Where an electronic road toll system on the territory of a Member State is substantially modified, that Member State shall take the measures necessary to ensure that the toll charger responsible for the system establishes and publishes in the EETS domain statement, in addition to the elements referred to in the first subparagraph, the detailed planning of the re-assessment of conformity to specifications and of the suitability for use of the interoperability constituents of EETS providers already accredited to the system before its substantial modification. The planning shall allow for the re-accreditation of concerned EETS providers at the latest one month before the operational launch of the modified system. The toll charger shall respect that planning. 2. Member States shall take the measures necessary to ensure that each toll charger responsible for an EETS domain on the territory of that Member States sets up a test environment in which the EETS provider or its authorised representatives can check that its OBE is suitable for use in the toll charger's EETS domain and obtain certification of the successful completion of the respective tests. Member States shall take the measures necessary to allow toll chargers to set up a single test environment for more than one EETS domain, and to allow one authorised representative to check the suitability for use of one type of OBE on behalf of more than one EETS provider. Member States shall take the measures necessary to allow toll chargers to require EETS providers or their authorised representatives to cover the cost of the respective tests. 3. Member States shall not prohibit, restrict or hinder the placing on the market of interoperability constituents for use in EETS where they bear the CE marking or either a declaration of conformity to specifications or a declaration of suitability for use, or both. In particular, Member States shall not require checks which have already been carried out as part of the procedure for checking conformity to specifications or suitability for use, or both. 4. The Commission shall adopt delegated acts in accordance with Article 30, at the latest by 19 October 2019, to lay down the requirements for interoperability constituents regarding safety and health, reliability and availability, environment protection, technical compatibility, security and privacy and operation and management. 5. The Commission shall also adopt delegated acts in accordance with Article 30, at the latest by 19 October 2019, to lay down the general infrastructure requirements regarding: (a) the accuracy of toll declaration data with a view to guaranteeing equality of treatment between EETS users in respect of tolls and charges; (b) the identification, through the OBE, of the responsible EETS provider; (c) the use of open standards for the interoperability constituents of the EETS equipment; (d) the integration of the OBE in the vehicle; and (e) the signalisation, to the driver, of the requirement to pay a road fee. 6. The Commission shall adopt implementing acts, at the latest by 19 October 2019, to lay down the following specific infrastructure requirements: (a) requirements on common communication protocols between toll chargers and EETS providers equipment; (b) requirements on mechanisms for toll chargers to detect whether a vehicle circulating on their EETS domain is equipped with a valid and functioning OBE; (c) requirements on the human-machine interface in the OBE; (d) requirements applying specifically to interoperability constituents in microwave technologies-based toll systems; and (e) requirements applying specifically in Global Navigation Satellite System (GNSS)-based toll systems. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). 7. The Commission shall adopt implementing acts, at the latest by 19 October 2019, to lay down the procedure to be applied by the Member States for assessing the conformity to specifications and suitability for use of interoperability constituents, including the content and format of the EC declarations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). CHAPTER V SAFEGUARD CLAUSES Article 16 Safeguard procedure 1. Where a Member State has reason to believe that interoperability constituents bearing a CE marking and placed on the market are unlikely, when used as intended, to meet the relevant requirements, it shall take all necessary steps to restrict their field of application, prohibit their use or withdraw them from the market. The Member State shall immediately inform the Commission of the measures taken and give the reasons for its decision, stating in particular whether failure to conform is due to: (a) incorrect application of technical specifications; or (b) inadequacy of technical specifications. 2. The Commission shall consult the concerned Member State, manufacturer, EETS provider or their authorised representatives established within the Union as quickly as possible. Where, following that consultation, the Commission establishes that the measure is justified, it shall immediately inform the Member State concerned as well as the other Member States. However, where, following that consultation, the Commission establishes that the measure is unjustified, it shall immediately inform the Member State concerned, as well as the manufacturer or its authorised representative established within the Union and the other Member States. 3. Where interoperability constituents bearing the CE marking fail to comply with interoperability requirements, the competent Member State shall require the manufacturer or its authorised representative established in the Union to restore the interoperability constituent to a state of conformity to specifications or suitability for use, or both, under the conditions laid down by that Member State and shall inform the Commission and the other Member States thereof. Article 17 Transparency of assessments Any decision taken by a Member State or a toll charger concerning the assessment of conformity to specifications or suitability for use of interoperability constituents and any decision taken pursuant to Article 16 shall set out in detail the reasons on which it is based. It shall be notified as soon as possible to the concerned manufacturer, EETS provider or their authorised representatives, together with an indication of the remedies available under the laws in force in the Member State concerned and of the time limits allowed for the exercise of such remedies. CHAPTER VI ADMINISTRATIVE ARRANGEMENTS Article 18 Single contact office Each Member State with at least two EETS domains on its territory shall designate a single contact office for EETS providers. The Member State shall make public the contact details of that office, and provide them, upon request, to interested EETS providers. The Member State shall take the measures necessary to ensure that, upon request of the EETS provider, the contact office facilitates and coordinates early administrative contacts between the EETS provider and the toll chargers responsible for the EETS domains on the territory of the Member State. The contact office may be a natural person or a public or a private body. Article 19 Notified bodies 1. Member States shall notify to the Commission and the other Member States any bodies entitled to carry out or supervise the procedure for the assessment of conformity to specifications or suitability for use referred to in the implementing acts referred to in Article 15(7), indicating each body's area of competence, and the identification numbers obtained in advance from the Commission. The Commission shall publish in the Official Journal of the European Union the list of bodies, their identification numbers and areas of competence, and shall keep the list updated. 2. Member States shall apply the criteria provided for in the delegated acts referred to in paragraph 5 of this Article for the assessment of the bodies to be notified. Bodies meeting the assessment criteria provided for in the relevant European standards shall be deemed to meet the said criteria. 3. A Member State shall withdraw approval from a body which no longer meets the criteria provided for in the delegated acts referred to in paragraph 5 of this Article. It shall immediately inform the Commission and the other Member States thereof. 4. Where a Member State or the Commission considers that a body notified by another Member State does not meet the criteria provided for in the delegated acts referred to in paragraph 5 of this Article, the matter shall be referred to the Electronic Toll Committee referred to in Article 31(1), which shall deliver its opinion within three months. In the light of the opinion of that Committee, the Commission shall inform the Member State which notified the body in question of any changes that are necessary for the notified body to retain the status conferred upon it. 5. The Commission shall adopt delegated acts in accordance with Article 30, at the latest by 19 October 2019, to lay down the minimum criteria of eligibility for notified bodies. Article 20 Coordination Group A Coordination Group of the bodies notified under Article 19(1) (the \u2018Coordination Group\u2019) shall be set up as a working group of the Electronic Toll Committee referred to in Article 31(1), in accordance with that Committee's Rules of Procedure. Article 21 Registers 1. For the purposes of the implementation of this Directive, each Member State shall keep a national electronic register of the following: (a) the EETS domains within their territory, including information relating to: (i) the corresponding toll chargers; (ii) the tolling technologies employed; (iii) the toll context data; (iv) the EETS domain statement; and (v) the EETS providers having EETS contracts with the toll chargers active in the territory of that Member State; (b) the EETS providers to whom it has granted registration in accordance with Article 4; and (c) the details of the single contact office referred to in Article 18 for EETS including a contact email address and telephone number. Unless otherwise specified, Member States shall verify at least once a year that the requirements set out in points (a), (d), (e) and (f) of Article 4 are still met, and shall update the register accordingly. The register shall also contain the conclusions of the audit provided for in point (e) of Article 4. A Member State shall not be held liable for the actions of the EETS providers mentioned in its register. 2. Member States shall take the measures necessary to ensure that all the data contained in the national electronic register are kept up-to-date and are accurate. 3. The registers shall be electronically accessible to the public. 4. These registers shall be available as of 19 October 2021. 5. At the end of each calendar year, the Member States authorities in charge of the registers shall communicate, to the Commission, by electronic means, the registers of EETS domains and EETS providers. The Commission shall make the information available to the other Member States. Any inconsistencies with the situation in a Member State shall be brought to the attention of the Member State of registration and of the Commission. CHAPTER VII PILOT SYSTEMS Article 22 Pilot toll systems 1. To allow for EETS technical development, Member States may temporarily authorise, on limited parts of their toll domain and in parallel with the EETS compliant system, pilot toll systems incorporating new technologies or concepts which do not comply with one or more provisions of this Directive. 2. EETS providers shall not be required to participate in pilot toll systems. 3. Before starting a pilot toll system, the Member State concerned shall request the authorisation of the Commission. The Commission shall issue the authorisation or refuse it, in the form of a Decision, within six months from the moment it received the request. The Commission may refuse the authorisation if the pilot toll system could prejudice the correct functioning of the regular electronic road toll system or of the EETS. The initial period of such authorisation shall not exceed three years. CHAPTER VIII EXCHANGE OF INFORMATION ON THE FAILURE TO PAY ROAD FEES Article 23 Procedure for the exchange of information between Member States 1. In order to allow the identification of the vehicle, and the owner or holder of that vehicle, for which a failure to pay a road fee has been established, each Member State shall grant access only to other Member States' national contact points to the following national vehicle registration data, with the power to conduct automated searches thereon: (a) data relating to vehicles; and (b) data relating to the owners or holders of the vehicle. The data elements referred to in points (a) and (b) which are necessary in order to conduct an automated search shall comply with Annex I. 2. For the purposes of the exchange of data referred to in paragraph 1, each Member State shall designate a national contact point. Member States shall take the measures necessary to ensure that the exchange of information between Member States takes place only between the national contact points. The powers of the national contact points shall be governed by the applicable law of the Member State concerned. In that data exchange process, particular attention shall be paid to the proper protection of personal data. 3. When conducting an automated search in the form of an outgoing request, the national contact point of the Member State in whose territory there was a failure to pay a road fee shall use a full registration number. Those automated searches shall be conducted in compliance with the procedures referred to in points 2 and 3 of Chapter 3 of the Annex to Council Decision 2008/616/JHA (16) and with the requirements of Annex I to this Directive. The Member State in whose territory there was a failure to pay a road fee shall use the data obtained in order to establish who is liable for the failure to pay that fee. 4. Member States shall take the measures necessary to ensure that the exchange of information is carried out using the European Vehicle and Driving Licence Information System (Eucaris) software application and amended versions of this software, in compliance with Annex I to this Directive and with points 2 and 3 of Chapter 3 of the Annex to Decision 2008/616/JHA. 5. Each Member State shall bear its own costs arising from the administration, use and maintenance of the software applications referred to in paragraph 4. Article 24 Information letter on the failure to pay a road fee 1. The Member State in whose territory there was a failure to pay a road fee shall decide whether or not to initiate follow-up proceedings in relation to the failure to pay a road fee. Where the Member State in whose territory there was a failure to pay a road fee decides to initiate such proceedings, that Member State shall, in accordance with its national law, inform the owner, the holder of the vehicle or the otherwise identified person suspected of failing to pay the road fee. This information shall, as applicable under national law, include the legal consequences thereof within the territory of the Member State in which there was a failure to pay a road fee under the law of that Member State. 2. When sending the information letter to the owner, the holder of the vehicle or to the otherwise identified person suspected of failing to pay the road fee, the Member State in whose territory there was a failure to pay a road fee shall, in accordance with its national law, include any relevant information, notably the nature of the failure to pay the road fee, the place, date and time of the failure to pay the road fee, the title of the texts of the national law infringed, the right to appeal and to have access to information, and the sanction and, where appropriate, data concerning the device used for detecting the failure to pay a road fee. For that purpose, the Member State in whose territory there was a failure to pay a road fee shall base the information letter on the template set out in Annex II. 3. Where the Member State in whose territory there was a failure to pay a road fee decides to initiate follow-up proceedings in relation to the failure to pay a road fee, it shall, for the purpose of ensuring the respect of fundamental rights, send the information letter in the language of the registration document of the vehicle, if available, or in one of the official languages of the Member State of registration. Article 25 Follow-up proceedings by the levying entities 1. The Member State on whose territory there was a failure to pay a road fee may provide to the entity responsible for levying the road fee the data obtained through the procedure referred to in Article 23(1) only if the following conditions are met: (a) the data transferred is limited to what is needed by that entity to obtain the road fee due; (b) the procedure for obtaining the road fee due complies with the procedure provided for in Article 24; (c) the entity concerned is responsible for carrying out this procedure; and (d) compliance with the payment order issued by the entity receiving the data puts an end to the failure to pay a road fee. 2. Member States shall ensure that the data provided to the responsible entity are used solely for the purpose of obtaining the road fee due and is immediately deleted once the road fee is paid or, if the failure to pay persists, within a reasonable period after the transfer of the data, to be set by the Member State. Article 26 Reporting by Member States to the Commission Each Member State shall send a comprehensive report to the Commission by 19 April 2023 and every three years thereafter. The comprehensive report shall indicate the number of automated searches conducted by the Member State in whose territory there was a failure to pay a road fee addressed to the national contact point of the Member State of registration, following failures to pay road fees that occurred on its territory, together with the number of failed requests. The comprehensive report shall also include a description of the situation at national level in relation to the follow-up concerning the failures to pay road fees, based on the proportion of such failures to pay road fees which have been followed up by information letters. Article 27 Data protection 1. Regulation (EU) 2016/679 and the national laws, regulations or administrative provisions transposing Directives 2002/58/EC and (EU) 2016/680 shall apply to personal data processed under this Directive. 2. Member States shall, in accordance with applicable data protection legislation, take the measures necessary, to ensure that: (a) the processing of personal data for the purposes of Articles 23, 24 and 25 is limited to the types of data listed in Annex I to this Directive; (b) personal data are accurate, kept up-to date and requests for rectification or erasure are handled without undue delay; and (c) a time limit is established for the storage of personal data. Member States shall take the measures necessary to ensure that personal data processed under this Directive are used only for the purposes of: (a) identification of suspected offenders in view of the obligation to pay road fees within the scope of Article 5(8); (b) ensuring the compliance of the toll charger as regards its obligations to tax authorities within the scope of Article 5(9); and (c) identification of the vehicle and the owner or holder of the vehicle for which a failure to pay a road fee has been established within the scope of Articles 23 and 24. Member States shall also take the measures necessary to ensure that the data subjects have the same rights of information, access, rectification, erasure and restriction of processing, and to lodge a complaint with a data protection supervisory authority, compensation and an effective judicial remedy as provided for in Regulation (EU) 2016/679 or, where applicable, Directive (EU) 2016/680. 3. This Article shall not affect the possibility of Member States to restrict the scope of the obligations and rights provided for in certain provisions of Regulation (EU) 2016/679 in accordance with Article 23 of that Regulation for the purposes listed in the first paragraph of that Article. 4. Any person concerned shall have the right to obtain, without undue delay, information on which personal data recorded in the Member State of registration were transmitted to the Member State in which there was a failure to pay a road fee, including the date of the request and the competent authority of the Member State in whose territory there was a failure to pay a road fee. CHAPTER IX FINAL PROVISIONS Article 28 Report 1. By 19 April 2023, the Commission shall present a report to the European Parliament and to the Council on the implementation and effects of this Directive, in particular as regards the advancement and deployment of the EETS and the effectiveness and efficiency of the mechanism for the exchange of data in the framework of the investigation of events of failure to pay road fees. The report shall analyse in particular the following: (a) the effect of Article 5(1) and (2) on the deployment of EETS, with a particular focus on the availability of the service in small or peripheral EETS domains; (b) the effectiveness of Articles 23, 24 and 25 on the reduction in the number of failures to pay road fees in the Union; and (c) the progress made on interoperability aspects between electronic road toll systems using satellite positioning and 5,8 GHz microwave technology. 2. The report shall be accompanied, if appropriate, by a proposal to the European Parliament and the Council for further revision of this Directive, regarding notably the following elements: (a) additional measures to ensure that the EETS is available in all EETS domains, including small and peripheral ones; (b) measures to further facilitate the cross-border enforcement of the obligation to pay road fees in the Union, including mutual assistance arrangements; and (c) the extension of the provisions facilitating cross-border enforcement to low emission zones, restricted access zones or other urban vehicle access regulation schemes. Article 29 Delegated acts The Commission is empowered to adopt delegated acts, in accordance with Article 30, updating Annex I to take into account any relevant amendments to be made to Council Decisions 2008/615/JHA (17) and 2008/616/JHA or where this is required by any other relevant legal acts of the Union. Article 30 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 8(5), Article 10(3), Article 15(4) and (5), Article 19(5) and Article 29 shall be conferred on the Commission for a period of five years from 18 April 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 8(5), Article 10(3), Article 15(4) and (5), Article 19(5) and Article 29 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 8(5), Article 10(3), Article 15(4) and (5), Article 19(5) and Article 29 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 31 Committee procedure 1. The Commission shall be assisted by the Electronic Toll Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. When reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 32 Transposition 1. Member States shall adopt and publish, by 19 October 2021, the laws, regulations and administrative provisions necessary to comply with Articles 1 to 27 and Annexes I and II. They shall immediately communicate the text of those measures to the Commission. They shall apply those measures from 19 October 2021. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 33 Repeal Directive 2004/52/EC is repealed with effect from 20 October 2021, without prejudice to the obligations of the Member States relating to the time-limit for the transposition into national law of the Directive set out in Annex III, Part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex IV. Article 34 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 35 Addressees This Directive is addressed to the Member States. Done at Brussels, 19 March 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 81, 2.3.2018, p. 181. (2) OJ C 176, 23.5.2018, p. 66. (3) Position of the European Parliament of 14 February 2019 (not yet published in the Official Journal) and decision of the Council of 4 March 2019. (4) Directive 2004/52/EC of the European Parliament and of the Council of 29 April 2004 on the interoperability of electronic road toll systems in the Community (OJ L 166, 30.4.2004, p. 124). (5) Directive (EU) 2015/413 of the European Parliament and of the Council of 11 March 2015 facilitating cross-border exchange of information on road-safety-related traffic offences (OJ L 68, 13.3.2015, p. 9). (6) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (7) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (8) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (9) OJ L 123, 12.5.2016, p. 1. (10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (11) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (12) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (13) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). (14) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). (15) Directive 1999/62/EC of the European Parliament and of the Council of 17 June 1999 on the charging of heavy goods vehicles for the use of certain infrastructures (OJ L 187, 20.7.1999, p. 42). (16) Council Decision 2008/616/JHA of 23 June 2008 on the implementation of Decision 2008/615/JHA on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime (OJ L 210, 6.8.2008, p. 12). (17) Council Decision 2008/615/JHA of 23 June 2008 on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime (OJ L 210, 6.8.2008, p. 1). ANNEX I Data elements necessary to conduct the automated search referred to in Article 23(1) Item M/O (1) Remarks Data relating to the vehicle M Member State of registration M Registration number M (A (2)) Data relating to the failure to pay a road fee M Member State in whose territory there was a failure to pay a road fee M Reference date of the occurrence M Reference time of the occurrence M Data elements provided as a result of the automated search conducted pursuant to Article 23(1) Part I. Data relating to vehicles Item M/O (3) Remarks Registration number M Chassis number/VIN M Member State of registration M Make M (D.1 (4)) e.g. Ford, Opel, Renault Commercial type of the vehicle M (D.3) e.g. Focus, Astra, Megane EU Category Code M (J) e.g. mopeds, motorbikes, cars Euro emissions class M e.g. Euro 4, Euro 6 Part II. Data relating to owners or holders of the vehicles Item M/O (5) Remarks Data relating to holders of the vehicle (C.1 (6)) The data refer to the holder of the specific registration certificate. Registration holders' (company) name M (C.1.1) Separate fields shall be used for surname, infixes, titles, etc., and the name in printable format shall be communicated. First name M (C.1.2) Separate fields for first name(s) and initials shall be used, and the name in printable format shall be communicated. Address M (C.1.3) Separate fields shall be used for street, house number and annex, post code, place of residence, country of residence, etc., and the address in printable format shall be communicated. Gender O Male, female Date of birth M Legal entity M Individual, association, company, firm, etc. Place of birth O ID Number O An identifier that uniquely identifies the person or the company. Data relating to owners of the vehicle (C.2) The data refer to the owner of the vehicle. Owners' (company) name M (C.2.1) First name M (C.2.2) Address M (C.2.3) Gender O Male, female Date of birth M Legal entity M Individual, association, company, firm, etc. Place of birth O ID Number O An identifier that uniquely identifies the person or the company. In case of scrap vehicles, stolen vehicles or number plates, or outdated vehicle registration no owner/holder information shall be provided. Instead, the message \u2018Information not disclosed\u2019 shall be returned. (1) M = mandatory when available in national register, O = optional. (2) Harmonised Union code, see Council Directive 1999/37/EC of 29 April 1999 on the registration documents for vehicles (OJ L 138, 1.6.1999, p. 57). (3) M = mandatory when available in national register, O = optional. (4) Harmonised Union code, see Directive 1999/37/EC. (5) M = mandatory when available in national register, O = optional. (6) Harmonised Union code, see Directive 1999/37/EC. ANNEX II TEMPLATE FOR THE INFORMATION LETTER referred to in Article 24 [Cover page] \u2026 \u2026 [Name, address and telephone number of sender] \u2026 \u2026 [Name and address of addressee] INFORMATION LETTER regarding the failure to pay a road fee occurred in \u2026 [name of the Member State in whose territory there was a failure to pay a road fee] Page 2 On \u2026 a failure to pay a road fee with the vehicle with registration [date] number \u2026 make \u2026 model \u2026 was detected by \u2026 [name of the responsible body] [Option 1] (1) You are registered as the holder of the registration certificate of the abovementioned vehicle. [Option 2] (1) The holder of the registration certificate of the abovementioned vehicle indicated that you were driving that vehicle when the failure to pay a road fee was committed. The relevant details of the failure to pay a road fee are described on page 3 below. The amount of the financial penalty due for the failure to pay a road fee is \u2026 EUR/national currency. (1) The amount of the road fee due to pay is \u2026 EUR/national currency. (1) Deadline for the payment is \u2026 You are advised to complete the attached reply form (page 4) and send it to the address shown, if you do not pay this financial penalty (1)/road fee (1). This letter shall be processed in accordance with the national law of \u2026 [name of the Member State in whose territory there was a failure to pay a road fee]. Page 3 Relevant details concerning the failure to pay a road fee (a) Data concerning the vehicle which was used in the failure to pay a road fee: Registration number: \u2026 Member State of registration: \u2026 Make and model \u2026 (b) Data concerning the failure to pay a road fee: Place, date and time where the failure to pay a road fee occurred: \u2026 \u2026 \u2026 \u2026 Nature and legal classification of the failure to pay a road fee: \u2026 \u2026 \u2026 \u2026 Detailed description of the failure to pay a road fee: \u2026 \u2026 Reference to the relevant legal provision(s): \u2026 \u2026 Description of or reference to the evidence regarding the failure to pay a road fee: \u2026 \u2026 (c) Data concerning the device that was used for detecting the failure to pay a road fee (2): Specification of the device: \u2026 \u2026 Identification number of the device: \u2026 \u2026 Expiry date for the last gauging: \u2026 \u2026 (1) Delete if not applicable. (2) Not applicable if no device has been used. Page 4 Reply form (please complete using block capitals) A. Identity of the driver: \u2014 Full name: \u2026 \u2026 \u2014 Place and date of birth: \u2026 \u2014 Number of driving licence: \u2026 delivered (date): \u2026 and at (place): \u2026 \u2014 Address: \u2026 \u2026 \u2026 \u2026 B. List of questions: 1. Is the vehicle, make \u2026, registration number \u2026, registered in your name? \u2026 yes/no (1) If not, the holder of the registration certificate is: \u2026 (name, first name, address) 2. Do you acknowledge that you failed to pay a road fee? yes/no (1) 3. If you do not acknowledge this, please explain why: \u2026 \u2026 Please send the completed form within 60 days from the date of this information letter to the following authority or entity: \u2026 at the following address \u2026 INFORMATION (Where the information letter is sent by the entity responsible for levying the road fee pursuant to Article 25): If the road fee due is not paid within the deadline set out in this information letter, this case will be forwarded to and examined by the competent authority of \u2026 [name of the Member State in whose territory there was a failure to pay a road fee]. If this case is not pursued, you will be informed within 60 days after receipt of the reply form or the proof of payment. (1) / (Where the information letter is sent by the competent authority of the Member State): This case will be examined by the competent authority of \u2026 [name of the Member State in whose territory there was a failure to pay a road fee]. If this case is not pursued, you will be informed within 60 days after receipt of the reply form or the proof of payment. (1) (1) Delete if not applicable. If this case is pursued, the following procedure applies: \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 \u2026 [to be filled in by the Member State in whose territory there was a failure to pay a road fee \u2013 what the further procedure will be, Including details of the possibility and procedure of appeal against the decision to pursue the case. These details shall In any event include: name and address of the authority or entity in charge of pursuing the case; deadline for payment; name and address of the body of appeal concerned; deadline for appeal]. This letter as such does not lead to legal consequences. Data protection disclaimer [Where Regulation (EU) 2016/679 is applicable: In accordance with Regulation (EU) 2016/679, you have the right to request access to, and rectification or erasure of, personal data or restriction of processing of your personal data or to object to the processing, as well as the right to data portability. You also have the right to lodge a complaint with [name and address of the relevant supervisory authority]. [Where Directive (EU) 2016/680 is applicable: In accordance with [name of the national law applying Directive (EU) 2016/680], you have the right to request from the controller access to and rectification or erasure of personal data and restriction of processing of your personal data. You also have the right to lodge a complaint with [name and address of the relevant supervisory authority].] ANNEX III PART A Repealed Directive with the amendment thereto (referred to in Article 33) Directive 2004/52/EC of the European Parliament and of the Council OJ L 166, 30.4.2004, p. 124. Regulation (EC) No 219/2009 of the European Parliament and of the Council OJ L 87, 31.3.2009, p. 109. PART B Time-limit for transposition into national law (referred to in Article 33) Directive Time-limit for transposition Directive 2004/52/EC 20 November 2005 ANNEX IV Correlation Table Directive 2004/52/EC This Directive Article 1(1) Article 1(1), first subparagraph (a) \u2014 Article 1(1), first subparagraph (b) Article 3(2), first sentence Article 1(1), second subparagraph Article 1(2), introductory wording Article 1(2), introductory wording Article 1(2)(a) Article 1(2)(a) Article 1(2)(b) \u2014 Article 1(2)(c) Article 1(2)(b) \u2014 Article 1(3) Article 1(3) Article 1(4) \u2014 Article 1(5) \u2014 Article 1(6) \u2014 Article 2 Article 2(1) Article 3(1), first subparagraph \u2014 Article 3(1), second subparagraph Article 2(2), first sentence \u2014 Article 4(7) Article 3(2) \u2014 Article 3(3) Article 2(2), second and third sentence Article 3(4) Article 2(2), fourth sentence \u2014 \u2014 Article 3(5) \u2014 Article 3(6) Article 2(3) \u2014 Article 2(4) \u2014 Article 2(5) \u2014 Article 2(6) \u2014 Article 2(7) Article 27 Article 3(1) \u2014 Article 3(2), first sentence Article 1(1), second subparagraph Article 3(2), second sentence \u2014 Article 3(2), third sentence Article 3(3) Article 3(4) \u2014 Article 4(1) Article 4(2) \u2014 Article 4(3) Article 4(4) \u2014 Article 4(5) \u2014 Article 4(7) Article 3(2) Article 4(8) Article 5(4) \u2014 Article 23 \u2014 Article 24 \u2014 Article 26 Article 2(7) Article 27 \u2014 Article 28 \u2014 Article 29 \u2014 Article 30 Article 5 Article 31 Article 6 Article 32(1) \u2014 Article 32(2) \u2014 Article 33 Article 7 Article 34 Article 8 Article 35 Annex \u2014 \u2014 Annex I \u2014 Annex II \u2014 Annex III \u2014 Annex IV", "summary": "Electronic road tolls \u2014 interoperability of national systems Electronic road tolls \u2014 interoperability of national systems SUMMARY OF: Directive (EU) 2019/520 \u2014 on the interoperability of electronic road toll systems and facilitating cross-border exchange of information on the failure to pay road fees in the EU WHAT IS THE AIM OF THE DIRECTIVE? It aims to make the EU electronic road toll rules more effective by: improving the interoperability of the system under which they operate; establishing a legal basis for the cross-border exchange of information on vehicles, and their owners or holders, which have failed to pay road fees in the EU. The directive recasts and repeals Directive 2004/52/EC from 20 October 2021. KEY POINTS Scope The directive does not apply to: non-electronic road toll systems; small, strictly local, road toll systems for which the costs would outweigh the benefits. European Electronic Toll Service (EETS) The EETS is the way to achieve an interoperable road toll system. It enables road users to subscribe to a single contract and to use on-board equipment* to pay electronic tolls across the EU. It is complementary to national road toll schemes. The directive sets out the rules for the EETS including: the general principles, including the procedure for registering EETS providers, and the rights and obligations for EETS providers and toll chargers; the role of the Conciliation Body, established to mediate between toll chargers and EETS providers; the provision for ensuring a single continuous service, i.e. once a vehicle\u2019s details have been entered in the system, no further input is required regardless of which EETS providers\u2019 domain the vehicle travels through; the establishment of a single contact office if an EU country has more than one EETS domain. Cross-border exchange of information The directive sets out rules for the exchange of information concerning the failure to pay road tolls including: the procedure for the exchange of information between EU countries; the information letter on the failure to pay a road toll; the provision of information by an EU country to the toll charging body. FROM WHEN DOES THE DIRECTIVE APPLY? It applies from 19 October 2019 and has to become law in the EU countries by 19 October 2021. However, the directive also sets out a number of specific deadlines: 19 October 2019 \u2014 relating to the Conciliation Body, implementing acts of the European Commission on specifications for electronic interfaces, interoperability constituents, and delegated acts of the Commission on notified bodies; 19 October 2021 \u2014 on the availability of national electronic registers; 19 April 2023 \u2014 on reporting by the EU countries to the Commission, and by the Commission to the European Parliament and Council; 17 April 2024 \u2014 on the Commission's power to adopt delegated acts. BACKGROUND The EU has also established rules for the sharing of information between EU countries in the case of road traffic offences. KEY TERMS On-board equipment: the complete set of hardware and software components to be used as part of the toll service which is installed or carried on board a vehicle in order to collect, store, process and remotely receive/transmit data, either as a separate device or installed in the vehicle. MAIN DOCUMENT Directive (EU) 2019/520 of the European Parliament and of the Council of 19 March 2019 on the interoperability of electronic road toll systems and facilitating cross-border exchange of information on the failure to pay road fees in the Union (OJ L 91, 29.3.2019, pp. 45-76) RELATED DOCUMENTS Directive (EU) 2015/413 of the European Parliament and of the Council of 11 March 2015 facilitating cross-border exchange of information on road-safety-related traffic offences (OJ L 68, 13.3.2015, pp. 9-25) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, pp. 62-106) Successive amendments to Directive 2014/53/EU have been incorporated into the original text. This consolidated version is of documentary value only. Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) (OJ L 96, 29.3.2014, pp. 79-106) See consolidated version. last update 21.06.2019"}
{"article": "25.7.2019 EN Official Journal of the European Union L 198/88 REGULATION (EU) 2019/1240 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on the creation of a European network of immigration liaison officers (recast) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 74 and Article 79(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Council Regulation (EC) No 377/2004 (2) has been substantially amended. Since further amendments are to be made, that Regulation should be recast in the interests of clarity. (2) The sharp increase of mixed migratory flows in 2015 and 2016 has put migration, asylum and border management systems under pressure. This has posed a challenge for the Union and Member States, showing the need to strengthen Union policy in the field of migration with a view to achieving a coordinated and effective European response. (3) The objective of Union policy in the field of migration is to replace irregular and uncontrolled migratory flows with safe and well-managed pathways, through a comprehensive approach aimed at ensuring, at all stages, the efficient management of migration flows in accordance with Chapter 2 of Title V of the Treaty on the Functioning of the European Union (TFEU). (4) Respect for human rights is a fundamental principle of the Union. The Union is committed to protecting the human rights and fundamental freedoms of all migrants, regardless of their migratory status, in full compliance with international law. As such, measures taken by immigration liaison officers when implementing this Regulation, in particular in cases involving vulnerable people, should respect fundamental rights in accordance with relevant international and Union law, including Articles 2 and 6 of the Treaty on European Union (TEU) and the Charter of Fundamental Rights of the European Union. (5) To ensure the effective implementation of all aspects of Union policies on immigration, consistent dialogue and cooperation should be pursued with key third countries of origin and transit of migrants and of applicants for international protection. Such cooperation, in line with the comprehensive approach set out in the European Agenda on Migration, should provide for better management of immigration, including departures and returns, support capacity to gather and share information, including on applicants\u2019 access to international protection and, where possible and relevant, on reintegration, and prevent and counter illegal immigration, smuggling of migrants and trafficking in human beings. (6) Protection tools include measures contained in the Global Approach to Migration and Mobility (GAMM). Legal immigration strategies and channels between the Union and third countries should also include labour migration, visas for students and family reunification, without prejudice to the national competences of Member States. (7) In light of the increasing demand for analysis and information to support evidence-based policy making and operational responses, there is a need for immigration liaison officers to ensure that their insight and knowledge contribute fully to the establishment of a comprehensive situational picture on third countries. (8) Information on the composition of migratory flows should, where possible and relevant, include information on declared migrants\u2019 age, gender profile and family and on unaccompanied minors. (9) The deployment of the current European Migration Liaison Officers to the key third countries of origin and transit, as called for in the conclusions of the special meeting of the heads of state and government on 23 April 2015, was a first step towards enhancing the engagement with third countries on migration-related issues and stepping up cooperation with immigration liaison officers deployed by Member States. Building on this experience, longer-term deployments of immigration liaison officers by the Commission to third countries should be foreseen to support development, implementation and maximise the impact of Union action on migration. (10) The objective of this Regulation is to ensure better coordination and optimise utilisation of the network of liaison officers deployed to third countries by the competent authorities of Member States, including, where appropriate, by law enforcement authorities, as well as by the Commission and Union agencies, in order to respond more effectively to the Union priorities of preventing and combating illegal immigration and related cross-border criminality such as smuggling of migrants and trafficking in human beings, facilitating dignified and effective return, readmission and reintegration activities, contributing to integrated management of the Union\u2019s external borders, as well as supporting management of legal immigration, including in the area of international protection, resettlement and pre-departure integration measures undertaken by Member States and the Union. Such coordination should fully respect the existing chain of command and reporting lines between immigration liaison officers and their respective deploying authorities as well as among immigration liaison officers themselves. (11) Building on Regulation (EC) No 377/2004, this Regulation aims to ensure that immigration liaison officers better contribute to the functioning of a European network of immigration liaison officers primarily by establishing a mechanism through which Member States, the Commission and Union agencies can more systematically coordinate the tasks and roles of their liaison officers deployed in third countries. (12) Given that liaison officers dealing with migration-related issues are deployed by different competent authorities and that their mandates and tasks may overlap, efforts should be made to enhance cooperation among officers operating within the same third country or region. Where immigration liaison officers are deployed to the Union\u2019s diplomatic missions in a third country by the Commission or Union agencies, they should facilitate and support the immigration liaison officers\u2019 network in that third country. Where appropriate, such networks may be extended to liaison officers deployed by countries other than Member States. (13) The establishment of a robust mechanism that ensures better coordination and cooperation among all liaison officers dealing with immigration issues as part of their duties is essential in order to minimise information gaps and duplication of work and maximise operational capabilities and effectiveness. A Steering Board should provide guidance in line with Union policy priorities, taking into account the Union\u2019s external relations, and should be given the necessary powers, in particular to adopt biennial work programmes for the activities of networks of immigration liaison officers, agree on tailored ad hoc actions for immigration liaison officers addressing priorities and emerging needs not already covered by the biennial work programme, allocate resources for agreed activities and be accountable for their execution. Neither the tasks of the Steering Board nor those of the facilitators of immigration liaison officer networks should affect the competence of deploying authorities with regard to tasking their respective immigration liaison officers. When carrying out its tasks, the Steering Board should take into account the diversity of networks of immigration liaison officers as well as the views of the Member States most concerned as regards relations with particular third countries. (14) A list of immigration liaison officers deployed to third countries should be established and updated regularly by the Steering Board. The list should include information related to the location, composition and activities of different networks, including the contact details and a summary of the duties of the deployed immigration liaison officers. (15) Joint deployment of liaison officers should be promoted with the aim of enhancing operational cooperation and information sharing between Member States, as well as to respond to needs at Union level, as defined by the Steering Board. Joint deployment by at least two Member States should be supported by Union funds encouraging engagement and providing added value to all Member States. (16) Special provision should be made for a wider Union capacity-building action for immigration liaison officers. Such capacity-building should comprise the development of common core curricula and pre-deployment training courses, including on fundamental rights, in cooperation with relevant Union agencies, and the reinforcement of the operational capacity of networks of immigration liaison officers. Such curricula should be non-compulsory and supplementary to national curricula established by deploying authorities. (17) Networks of immigration liaison officers should avoid duplicating the work of Union agencies and other Union instruments or structures, including the work of local Schengen cooperation groups, and should bring added value to what they already achieve in terms of collecting and exchanging information in the area of immigration, in particular by focusing on operational aspects. Those networks should act as facilitators and providers of information from third countries to support Union agencies in their functions and tasks, in particular where Union agencies have not yet established cooperative relations with third countries. Closer cooperation between networks of immigration liaison officers and relevant Union agencies should be established to that effect. Immigration liaison officers should at all times be aware that their actions might have operational or reputational consequences for local and regional networks of immigration liaison officers. They should act accordingly when carrying out their tasks. (18) Member State authorities should ensure that, where appropriate and in accordance with Union and national law, information obtained by liaison officers deployed to other Member States and strategic and operational analytical products of Union agencies in relation to illegal immigration, dignified and effective return and reintegration, cross-border criminality or international protection and resettlement effectively reach immigration liaison officers in third countries and that the information provided by immigration liaison officers is shared with the relevant Union agencies; in particular the European Border and Coast Guard Agency, European Union Agency for Law Enforcement Cooperation (Europol) and the European Asylum Support Office (EASO) within the scope of their respective legal frameworks. (19) In order to ensure the most effective use of information collected by the networks of immigration liaison officers, such information should be available through a secure web-based information exchange platform in accordance with applicable data protection legislation. (20) Information collected by immigration liaison officers should support the implementation of the technical and operational European integrated border management referred to in Regulation (EU) 2016/1624 of the European Parliament and of the Council (3) and contribute to the development and maintenance of national border surveillance systems in accordance with Regulation (EU) No 1052/2013 of the European Parliament and of the Council (4). (21) It should be possible to use the available resources of the Regulation (EU) No 515/2014 of the European Parliament and of the Council (5) to support the activities of a European network of immigration liaison officers as well as to pursue the joint deployment of immigration liaison officers by Member States. (22) Any processing, including the transfer, of personal data by Member States within the framework of this Regulation should be conducted in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (6). The Commission and Union agencies should apply Regulation (EU) 2018/1725 of the European Parliament and of the Council (7) when processing personal data. (23) The processing of personal data within the framework of this Regulation should be for the purposes of assisting the return of third-country nationals, facilitating the resettlement of persons in need of international protection and implementing Union and national measures in respect of admission for the purpose of legal migration and for the prevention and combating of illegal immigration, smuggling of migrants and trafficking in human beings. A legal framework that recognises the role of immigration liaison officers in this context is therefore necessary. (24) Immigration liaison officers need to process personal data to facilitate the proper implementation of return procedures, the successful enforcement of return decisions, and reintegration where relevant and possible. The third countries of return are not often subject to adequacy decisions adopted by the Commission under Article 45 of Regulation (EU) 2016/679, and have often not concluded or do not intend to conclude a readmission agreement with the Union or otherwise provide for appropriate safeguards within the meaning of Article 46 of Regulation (EU) 2016/679. Despite the extensive efforts of the Union in cooperating with the main countries of origin of illegally staying third-country nationals subject to an obligation to return, it is not always possible to ensure that such third countries systematically fulfil the obligation established by international law to readmit their own nationals. Therefore, readmission agreements, concluded or being negotiated by the Union or the Member States and providing for appropriate safeguards for the transfer of data to third countries pursuant to Article 46 of Regulation (EU) 2016/679, cover a limited number of such third countries. In the situation where such agreements do not exist, personal data should be transferred by immigration liaison officers for the purposes of implementing the return operations of the Union in accordance with the conditions laid down in Article 49 of Regulation (EU) 2016/679. (25) As an exception from the requirement for an adequacy decision or appropriate safeguards, the transfer of personal data to third-country authorities under this Regulation should be allowed for implementing the return policy of the Union. It should therefore be possible for immigration liaison officers to use the derogation provided for in Article 49(1)(d) of Regulation (EU) 2016/679 subject to the conditions set out in that Article for the purposes of this Regulation, namely for the dignified and effective return of third-country nationals who do not fulfil or no longer fulfil the conditions for entry, stay or residence in the Member States in accordance with Directive 2008/115/EC of the European Parliament and of the Council (8). (26) In the interests of the persons concerned, immigration liaison officers should be able to process the personal data of persons in need of international protection subject to resettlement and of persons wishing to migrate legally to the Union, in order to confirm their identity and nationality. Immigration liaison officers operate in a context in which it is likely that they gain important insights into the activities of criminal organisations involved in smuggling of migrants and trafficking in human beings. Therefore, they should also be able to share personal data processed in the course of their duties with law enforcement authorities and within networks of immigration liaison officers, provided that the personal data in question is necessary either for the prevention and tackling of irregular migration or for the prevention, investigation, detection and prosecution of smuggling of migrants or trafficking in human beings. (27) The objective of this Regulation is to optimise utilisation of the network of immigration liaison officers deployed by Member States, Commission and Union agencies to third countries in order to implement Union priorities more effectively while respecting the national competences of Member States. Such Union priorities include ensuring a better management of migration, with a view to replacing irregular flows with safe and well-managed pathways through a comprehensive approach addressing all aspects of immigration, including preventing and combating smuggling of migrants and trafficking in human beings and illegal immigration. Further Union priorities are to facilitate dignified and effective return, readmission and reintegration, contributing to integrated management of the Union\u2019s external borders and to support management of legal immigration or international protection schemes. Since the objective of this Regulation cannot be sufficiently achieved by the Member States alone but can rather, by reason of their large scale and their effects throughout the Union, be better achieved through coordination at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (28) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters\u2019 association with the implementation, application and development of the Schengen acquis (9) which fall within the area referred to in Article 1, points A and E, of Council Decision 1999/437/EC (10). (29) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (11) which fall within the area referred to in Article 1, points A and E, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/149/JHA (12). (30) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (13) which fall within the area referred to in Article 1, points A and E, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (14). (31) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (32) On 1 October 2018, in accordance with Article 5(2) of Protocol No 19 on the Schengen acquis integrated into the framework of the European Union, annexed to the TEU and to the TFEU, the United Kingdom notified the Council of its wish not to take part in the adoption of this Regulation. In accordance with Article 5(3) of the said Protocol, the Commission presented on 31 January 2019 a proposal for a Council Decision concerning the notification by the United Kingdom of its wish no longer to take part in some of the provisions of the Schengen acquis which are contained in Regulation (EC) No 377/2004. On this basis, the Council decided on 18 February 2019 (15) that as from the day of entry into force of this Regulation, Council Decision 2000/365/EC (16) and point 6 of Annex I to Council Decision 2004/926/EC (17) shall cease to apply to the United Kingdom as regards Regulation (EC) No 377/2004 and any further amendments thereto. (33) Ireland is taking part in this Regulation, in accordance with Article 5(1) of Protocol No 19, and Article 6(2) of Council Decision 2002/192/EC (18). (34) The participation of Ireland in this Regulation in accordance with Article 6(2) of Decision 2002/192/EC relates to the responsibilities of the Union for taking measures developing the provisions of the Schengen acquis against the organisation of illegal immigration in which Ireland participates. (35) This Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within, respectively, the meaning of Article 3(1) of the 2003 Act of Accession, Article 4(1) of the 2005 Act of Accession and Article 4(1) of the 2011 Act of Accession, HAVE ADOPTED THIS REGULATION: Article 1 Scope 1. This Regulation lays down rules to enhance cooperation and coordination among immigration liaison officers deployed to third countries by Member States, the Commission and Union agencies, through the creation of a European network of immigration liaison officers. 2. This Regulation is without prejudice to the responsibility of Member State authorities, the Commission and Union agencies for defining the scope and assignment of tasks and reporting lines of their respective immigration liaison officers, and to the tasks of immigration liaison officers within the framework of their responsibilities under Union and national law, policies or procedures, or under special agreements concluded with the host country or international organisations. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018immigration liaison officer\u2019 means a liaison officer designated and deployed abroad, by the competent authorities of a Member State, or by the Commission or by a Union agency, in accordance with the respective legal basis, to deal with immigration-related issues, also when that is only a part of their duties; (2) \u2018deployed abroad\u2019 means deployed to a third country, for a reasonable time period to be determined by the responsible authority, to one of the following: (a) a diplomatic mission of a Member State; (b) the competent authorities of a third country; (c) an international organisation; (d) a diplomatic mission of the Union; (3) \u2018personal data\u2019 means personal data as defined in point (1) of Article 4 of the Regulation (EU) 2016/679; (4) \u2018return\u2019 means return as defined in point (3) of Article 3 of Directive 2008/115/EC. Article 3 Tasks of immigration liaison officers 1. Immigration liaison officers shall carry out their tasks within the framework of their responsibilities determined by the deploying authorities and in accordance with the provisions, including those on the protection of personal data, laid down in Union and national laws and in any agreements or arrangements concluded with third countries or international organisations. 2. Immigration liaison officers shall carry out their tasks in accordance with fundamental rights as general principles of Union law as well as international law, including human rights obligations. They shall have particular consideration for vulnerable persons and take into account the gender dimension of migration flows. 3. Each deploying authority shall ensure that immigration liaison officers establish and maintain direct contacts with the competent authorities of third countries, including, when appropriate, with local authorities, and any relevant organisations operating within the third country, including international organisations, notably with a view to implementing this Regulation. 4. Immigration liaison officers shall collect information, for use either at operational level, strategic level, or both. Information collected under this paragraph shall be collected in accordance with Article 1(2) and shall not contain personal data, without prejudice to Article 10(2). Such information shall cover the following issues in particular: (a) European integrated border management at the external borders, with a view to managing migration effectively; (b) migratory flows originating from or transiting through the third country, including where possible and relevant, the composition of migratory flows and migrants\u2019 intended destination; (c) routes used by migratory flows originating from or transiting through the third country in order to reach the territories of the Member States; (d) the existence, activities and modi operandi of criminal organisations involved in smuggling of migrants and trafficking in human beings along the migratory routes; (e) incidents and events that have the potential to be or to cause new developments with respect to migratory flows; (f) methods used for counterfeiting or falsifying identity documents and travel documents; (g) ways and means to assist the authorities in third countries in preventing illegal immigration flows originating from or transiting through their territories; (h) pre-departure measures available to immigrants in the country of origin or in host third countries that support successful integration upon legal arrival in Member States; (i) ways and means to facilitate return, readmission and reintegration; (j) effective access to protection that the third country has put in place, including in favour of vulnerable persons; (k) existing and possible future legal immigration strategies and channels between the Union and third countries, taking into account skills and labour market needs in Member States, as well as resettlement and other protection tools; (l) capacity, capability, political strategies, legislation and legal practices of third countries and stakeholders, including, where possible and relevant, regarding reception and detention centres and the conditions therein, as relevant to the issues referred to in points (a) to (k). 5. Immigration liaison officers shall coordinate among themselves and with relevant stakeholders regarding the provision of their capacity-building activities to authorities and other stakeholders in third countries. 6. Immigration liaison officers may render assistance, taking into account their expertise and training, in: (a) establishing the identity and nationality of third-country nationals and facilitating their return in accordance with Directive 2008/115/EC, as well as assisting their reintegration, where relevant and possible; (b) confirming the identity of persons in need of international protection for the purposes of facilitating their resettlement in the Union, including by providing them, where possible, with adequate pre-departure information and support; (c) confirming identity and facilitating implementation of Union and national measures in respect of the admission of legal immigrants; (d) sharing information obtained in the course of their duties within networks of immigration liaison officers and with competent authorities of the Member States, including law enforcement authorities, in order to prevent and detect illegal immigration as well as combat smuggling of migrants and trafficking in human beings. Article 4 Notification of the deployment of immigration liaison officers 1. Member States, the Commission and the Union agencies shall inform the Steering Board established in Article 7 of their plans for and actual deployment of immigration liaison officers, including a description of their duties and the duration of their deployment. The activity reports referred to in point (c) of Article 8(2) shall include an overview of the deployments of immigration liaison officers. 2. The information referred to in paragraph 1 shall be made available on the secure web-based information exchange platform provided for in Article 9. Article 5 Creation of local or regional networks of immigration liaison officers 1. Immigration liaison officers deployed to the same countries or regions shall constitute local or regional cooperation networks and cooperate, where and when appropriate, with liaison officers deployed by countries other than Member States. Within the framework of such networks, immigration liaison officers shall in accordance with Article 1(2), in particular: (a) meet regularly and whenever necessary; (b) exchange information and practical experience, in particular at meetings and via the secure web-based information exchange platform provided for in Article 9; (c) exchange information, where appropriate, on experience regarding access to international protection; (d) coordinate positions to be adopted in contacts with commercial carriers, where appropriate; (e) attend joint specialised training courses, when appropriate, including on fundamental rights, trafficking in human beings, smuggling of migrants, document fraud or access to international protection in third countries; (f) organise information sessions and training courses for members of the diplomatic and consular staff of the missions of the Member States in the third country, when appropriate; (g) adopt common approaches on methods for the collection and reporting of strategically relevant information, including risk analyses; (h) set up regular contacts with similar networks in the third country and in neighbouring third countries, as appropriate. 2. Immigration liaison officers deployed by the Commission shall facilitate and support the networks provided for in paragraph 1. In locations where the Commission does not deploy immigration liaison officers, immigration liaison officers deployed by Union agencies shall facilitate and support the networks provided for in paragraph 1. In locations where neither the Commission nor Union agencies deploy immigration liaison officers, the network shall be facilitated by an immigration liaison officer, as agreed by members of the network. 3. The Steering Board shall be notified without undue delay of the appointment of the designated network facilitator or where no facilitator is designated. Article 6 Joint deployment of immigration liaison officers 1. Member States may bilaterally or multilaterally agree that immigration liaison officers who are deployed to a third country or international organisation by a Member State shall also look after the interests of one or more other Member States. 2. Member States may also agree that their immigration liaison officers shall share certain tasks among each other, on the basis of their competence and training. 3. Where two or more Member States jointly deploy an immigration liaison officer, those Member States may receive Union financial support pursuant to Regulation (EU) No 515/2014. Article 7 Steering Board 1. A Steering Board for a European network of immigration liaison officers is established. 2. The Steering Board shall be composed of one representative of each Member State, two representatives of the Commission, one representative of the European Border and Coast Guard Agency, one representative of Europol and one representative of EASO. To that end, each Member State shall appoint a member of the Steering Board as well as an alternate who will represent the member in his or her absence. The Steering Board members shall be appointed in particular on the basis of their relevant experience and expertise in managing liaison officer networks. 3. Countries associated with the implementation, application and development of the Schengen acquis shall participate in the Steering Board and shall appoint one representative each as members without voting rights. They shall be allowed to express views on all issues discussed and decisions taken by the Steering Board. When taking decisions on matters that are relevant for immigration liaison officers deployed by countries associated with the implementation, application and development of the Schengen acquis, the Steering Board shall take due account of the views expressed by the representatives of those countries. 4. Experts, representatives of national authorities, international organisations and relevant Union institutions, bodies, offices and agencies who are not members of the Steering Board may be invited by the Steering Board to attend its meetings as observers. 5. The Steering Board may organise joint meetings with other networks or organisations. 6. A Commission representative shall act as the Chair of the Steering Board. The Chair shall: (a) ensure continuity and organise the work of the Steering Board, including supporting the preparation of the biennial work programme and biennial report on the activities; (b) advise the Steering Board in ensuring that the collective activities agreed are consistent and coordinated with relevant Union instruments and structures and reflect the priorities of the Union in the area of migration; (c) convene meetings of the Steering Board. To achieve the objectives of the Steering Board, the Chair shall be assisted by a Secretariat. 7. The Steering Board shall meet at least twice a year. 8. The Steering Board shall adopt decisions by an absolute majority of its members with voting rights. 9. Decisions adopted by the Steering Board shall be communicated to the relevant immigration liaison officers by the respective deploying authorities. Article 8 Tasks of the Steering Board 1. The Steering Board shall establish its own rules of procedure on the basis of a proposal by the Chair within three months of its first meeting. The rules of procedure shall set out the details of the voting arrangements. The rules of procedure shall include, in particular, the conditions for a member to act on behalf of another member as well as any quorum requirements. 2. Considering the priorities of the Union in the area of immigration and within the scope of the tasks of immigration liaison officers as defined in this Regulation and in accordance with Article 1(2), the Steering Board shall carry out the following activities based on a comprehensive situational picture and on analyses provided by the relevant Union agencies: (a) establish priorities and plan activities by adopting a biennial work programme indicating the resources needed to support that work; (b) regularly review the implementation of its activities with a view to proposing amendments to the biennial work programme as appropriate, and as regards the appointment of network facilitators and progress made by networks of immigration liaison officers in their cooperation with competent authorities in third countries; (c) adopt the biennial activity report, including the overview referred to in the second subparagraph of Article 4(1), to be prepared by the Chair of the Steering Board, (d) update the list of deployments of immigration liaison officers ahead of each Steering Board meeting; (e) identify deployment gaps and outline possibilities for the deployment of immigration liaison officers. The Steering Board shall transmit the documents referred to in points (a) and (c) of the first subparagraph of this paragraph to the European Parliament. 3. Considering the operational needs of the Union in the area of immigration and within the scope of the tasks of immigration liaison officers as defined in this Regulation and in accordance with Article 1(2), the Steering Board shall carry out the following activities: (a) agree on ad hoc actions by networks of immigration liaison officers; (b) monitor the availability of information between immigration liaison officers and Union agencies, and make recommendations for necessary actions where required; (c) support the development of the capabilities of immigration liaison officers, including through developing supplementary and non-compulsory common core curricula, pre-deployment training, guidelines on observing fundamental rights in their activities with a particular focus on vulnerable persons, and the organisation of joint seminars on subjects as referred to in Article 3(4), taking into account training tools developed by the relevant Union agencies or other international organisations; (d) ensure that information is exchanged through the secure web-based information exchange platform as provided for in Article 9. 4. For the execution of the activities referred to in paragraphs 2 and 3, Member States may receive Union financial support in accordance with Regulation (EU) No 515/2014. Article 9 Information exchange platform 1. For the purposes of their respective tasks, immigration liaison officers, members of the Steering Board and facilitators of the network referred to in Article 5(2) shall ensure that all relevant information and statistics are uploaded to and exchanged via a secure web-based information exchange platform. That platform shall be set up by the Commission in agreement with the Steering Board and maintained by the Commission. No operational law enforcement information of a strictly confidential nature shall be exchanged via the secure web-based information exchange platform. 2. The information to be exchanged via the secure web-based information exchange platform shall include at least the following elements: (a) relevant documents, reports and analytical products as agreed by the Steering Board in accordance with Article 8(2) and (3); (b) biennial work programmes, biennial activity reports and the outcome of activities and ad hoc tasks of networks of immigration liaison officers as referred to in Article 8(2) and (3); (c) an up-to-date list of Steering Board members; (d) an up-to-date list of contact details of immigration liaison officers deployed to third countries, including their names, locations of deployment and region of responsibility, telephone numbers and email addresses; (e) other relevant documents related to the activities and decisions of the Steering Board. 3. With the exception of data as referred to in points (c) and (d) of paragraph 2, the information exchanged through the secure web-based information exchange platform shall not contain personal data or any links through which such personal data is directly or indirectly available. Access to data referred to in points (c) and (d) of paragraph 2 shall be restricted to immigration liaison officers, members of the Steering Board and duly authorised staff for the purpose of implementation of this Regulation. 4. The European Parliament shall be given access to certain parts of the secure web-based information exchange platform, as determined by the Steering Board in its rules of procedure and in accordance with the applicable Union and national rules and legislation. Article 10 Processing personal data 1. Immigration liaison officers shall carry out their tasks in accordance with Union and national personal data protection rules, as well as such rules contained in international agreements concluded with third countries or international organisations. 2. Immigration liaison officers may process personal data for the purpose of the tasks referred to in Article 3(6). Those personal data shall be erased when they are no longer necessary in relation to the purposes for which they were collected or otherwise processed in accordance with Regulation (EU) 2016/679. 3. Personal data processed pursuant to paragraph 2 may include: (a) biometric or biographic data, where necessary, to confirm the identity and nationality of third-country nationals for the purposes of return, including all types of documents which can be considered as proof or prima facie evidence of nationality; (b) passenger lists for return flights and other means of transport to third countries; (c) biometric or biographic data to confirm the identity and nationality of third-country nationals for the purpose of legal migration admission; (d) biometric or biographic data to confirm the identity and nationality of third-country nationals in need of international protection for the purpose of resettlement; (e) biometric, biographic data as well as other personal data necessary for establishing the identity of an individual and necessary for preventing and combating smuggling of migrants and trafficking in human beings, as well as personal data related to criminal networks\u2019 modi operandi, means of transports used, involvement of intermediaries and financial flows. Data under point (e) of the first subparagraph of this paragraph shall be processed for the sole purpose of executing the tasks referred to under point (d) of Article 3(6). 4. Any exchange of personal data shall be strictly limited to what is necessary for the purposes of this Regulation. 5. Transfers of personal data by immigration liaison officers to third countries and international organisations pursuant to this Article shall be carried out in accordance with Chapter V of Regulation (EU) 2016/679. Article 11 Consular cooperation This Regulation is without prejudice to the provisions on consular cooperation at a local level contained in Regulation (EC) No 810/2009 of the European Parliament and of the Council (19). Article 12 Report 1. Five years after the date of adoption of this Regulation, the Commission shall report to the European Parliament and the Council on the application of this Regulation. 2. Member States and the relevant Union agencies shall provide the Commission with the necessary information for the preparation of the report on the application of this Regulation. Article 13 Repeal Regulation (EC) No 377/2004 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 14 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) Position of the European Parliament of 16 April 2019 (not yet published in the Official Journal) and decision of the Council of 14 June 2019. (2) Council Regulation (EC) No 377/2004 of 19 February 2004 on the creation of an immigration liaison officers network (OJ L 64, 2.3.2004, p. 1). (3) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1). (4) Regulation (EU) No 1052/2013 of the European Parliament and of the Council of 22 October 2013 establishing the European Border Surveillance System (Eurosur) (OJ L 295, 6.11.2013, p. 11). (5) Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (OJ L 150, 20.5.2014, p. 143). (6) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (7) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (8) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (9) OJ L 176, 10.7.1999, p. 36. (10) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (11) OJ L 53, 27.2.2008, p. 52. (12) Council Decision 2008/149/JHA of 28 January 2008 on the conclusion, on behalf of the European Union, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 50). (13) OJ L 160, 18.6.2011, p. 21. (14) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (15) Council Decision (EU) 2019/304 of 18 February 2019 concerning the notification by the United Kingdom of Great Britain and Northern Ireland of its wish no longer to take part in some of the provisions of the Schengen acquis which are contained in Council Regulation (EC) No 377/2004 on the creation of an immigration liaison officers network (OJ L 51, 22.2.2019, p. 7). (16) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (17) Council Decision 2004/926/EC of 22 December 2004 on the putting into effect of parts of the Schengen acquis by the United Kingdom of Great Britain and Northern Ireland (OJ L 395, 31.12.2004, p. 70). (18) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland\u2019s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (19) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1). ANNEX I Repealed Regulation with the amendment thereto Council Regulation (EC) No 377/2004 (OJ L 64, 2.3.2004, p. 1) Regulation (EU) No 493/2011 of the European Parliament and of the Council (OJ L 141, 27.5.2011, p. 13) ANNEX II Correlation table Regulation (EC) No 377/2004 This Regulation \u2014 Article 1(1) \u2014 Article 2, introductory wording Article 1(1) Article 2, point (1) Article 1(2) Article 2, point (1) final wording Article 1(3) Article 2 point (2) Article 1(4) Article 1(2) Article 2(1) Article 3(3) Article 2(2), introductory wording Article 3(4), introductory wording Article 2(2), first indent Article 3(4)(b) Article 2(2), second indent Article 3(4)(c) Article 3(1) Article 4(1) first subparagraph Article 4(1) Article 5(1) Article 5(1) and (2) Article 6(1) and (2) Article 7 Article 11 \u2014 Annex I \u2014 Annex II", "summary": "Immigration liaison officers\u2019 network Immigration liaison officers\u2019 network SUMMARY OF: Regulation (EU) 2019/1240 \u2014 creation of a European network of immigration liaison officers WHAT IS THE AIM OF THE REGULATION? EU migration policy aims to replace irregular and uncontrolled migration with migration that is safe and well-managed, through a comprehensive approach aimed at ensuring efficient migration management. The regulation lays down rules aiming to ensure good cooperation, coordination and exchange of information among immigration liaison officers* deployed to non-EU countries by EU countries, the European Commission and EU agencies, through a European network of immigration liaison officers. KEY POINTS The regulation creates a European network of immigration liaison officers to assist in better migration management in order to meet the following EU priorities: preventing and combating illegal immigration and related cross-border crime, such as migrant smuggling and human trafficking; carrying out dignified and effective return*, readmission* and reintegration*; managing legal immigration, including international protection, resettlement, admission procedures and pre-departure integration measures taken by EU countries and the EU. Local or regional networks of immigration liaison officers Immigration liaison officers, deployed to the same countries or regions, constitute local or regional cooperation networks. Where necessary and appropriate, they will: share information and practical experience, including through regular meetings and a secure web-based information exchange platform; share information regarding access to international protection; coordinate positions on contacts with commercial carriers; attend joint specialised training courses, including on fundamental rights, human trafficking, migrant smuggling, document fraud and access to international protection in non-EU countries; organise information sessions and training courses for diplomatic and consular staff on missions in non-EU countries; adopt common approaches on methods for collecting and reporting strategically relevant information, including risk analyses; set up regular contacts with similar networks in the non-EU country and in neighbouring countries. Tasks of immigration liaison officers Liaison officers collect information, at operational or strategic level, or both, on: migration routes; the existence of criminal organisations involved in migrant smuggling and human trafficking along migration routes; the methods used to forge or falsify identity documents; ways to facilitate return, readmission and reintegration; measures to guarantee effective access to protection put in place by non-EU countries, including for the benefit of vulnerable persons; existing and possible future legal immigration strategies and channels between the EU and non-EU countries. Liaison officers can also provide assistance to authorities and other people involved in non-EU countries in the following areas: establishing the identity and nationality of non-EU nationals and facilitating their return, and helping in reintegration; identifying persons in need of international protection to facilitate resettlement in the EU, in particular by providing pre-departure information and support where possible; confirming the identity of legal immigrants and facilitating national and EU measures for their admission; sharing information within networks of liaison officers and with competent EU national authorities, including law enforcement, to prevent and detect illegal immigration and combat migrant smuggling and human trafficking. Measures taken by immigration liaison officers, in particular in cases involving vulnerable people, should respect fundamental rights in accordance with relevant international and EU law, including Article 2 and Article 6 of the Treaty on European Union and the Charter of Fundamental Rights of the European Union. Steering Board A Steering Board at EU level is set up to strengthen the management of the network and the coordination of immigration liaison officers, while respecting the existing chain of command and reporting lines between immigration liaison officers and their respective deploying authorities, and among immigration liaison officers themselves. The Steering Board comprises one representative from each EU country, two from the Commission, and one each from the European Border and Coast Guard Agency (also known as Frontex), Europol, and the European Asylum Support Office. Schengen-associated countries will appoint one representative each as members without voting rights. FROM WHEN DOES THE REGULATION APPLY? It has applied since 14 August 2019. Regulation (EU) 2019/1240 revised and replaced Regulation (EC) No 377/2004 and its subsequent amendments. BACKGROUND European Agenda on Migration \u2014 Factsheets (European Commission). KEY TERMS Immigration liaison officer: an officer designated and deployed in a non-EU country, by the competent authorities of an EU country, or by the Commission or by an EU agency, in accordance with their respective laws, to deal with immigration-related issues, including when that is only a part of their duties. Return: the movement of a person going from a host country back to a country of origin, country of nationality or habitual residence usually after spending a significant period of time in the host country whether voluntary or forced, assisted or spontaneous. Readmission: act by a country accepting the re-entry of an individual (own national, a non-national of that country or a stateless person). Reintegration: re-inclusion or re-incorporation of a person into a group or a process, e.g. of a migrant into the society of their country of return. MAIN DOCUMENT Regulation (EU) 2019/1240 of the European Parliament and of the Council of 20 June 2019 on the creation of a European network of immigration liaison officers (recast) (OJ L 198, 25.7.2019, pp. 88-104) RELATED DOCUMENTS Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, pp. 1-131) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, pp. 1-76) Successive amendments to Regulation (EU) 2016/1624 have been incorporated into the original text. This consolidated version is of documentary value only. Consolidated version of the Treaty on European Union \u2014 Title I \u2014 Common provisions \u2014 Article 2 (OJ C 202, 7.6.2016, p. 17) Consolidated version of the Treaty on European Union \u2014 Title I \u2014 Common provisions \u2014 Article 6 (ex Article 6 TEU) (OJ C 202, 7.6.2016, p. 19) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 A European Agenda on Migration (COM(2015) 240 final, 13.5.2015) Regulation (EU) No 1052/2013 of the European Parliament and of the Council of 22 October 2013 establishing the European Border Surveillance System (Eurosur) (OJ L 295, 6.11.2013, pp. 11-26) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, pp. 60-95) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 The Global Approach to Migration and Mobility (COM(2011) 743 final, 18.11.2011) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, pp. 98-107) Council Regulation (EC) No 377/2004 of 19 February 2004 on the creation of an immigration liaison officers network (OJ L 64, 2.3.2004, pp. 1-4) See consolidated version. last update 17.01.2020"}
{"article": "12.7.2019 EN Official Journal of the European Union L 188/67 REGULATION (EU) 2019/1157 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on strengthening the security of identity cards of Union citizens and of residence documents issued to Union citizens and their family members exercising their right of free movement (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 21(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Treaty on the European Union (TEU) resolved to facilitate the free movement of persons while ensuring the safety and security of the peoples of Europe, by establishing an area of freedom, security and justice, in accordance with the provisions of the TEU and of the Treaty on the Functioning of the European Union (TFEU). (2) Citizenship of the Union confers on every citizen of the Union the right of free movement, subject to certain limitations and conditions. Directive 2004/38/EC of the European Parliament and of the Council (3) gives effect to that right. Article 45 of the Charter of Fundamental Rights of the European Union (the Charter) also provides for freedom of movement and residence. Freedom of movement entails the right to exit and enter Member States with a valid identity card or passport. (3) Pursuant to Directive 2004/38/EC, Member States are to issue and renew identity cards or passports to their nationals in accordance with national laws. Furthermore, that Directive provides that Member States may require Union citizens and their family members to register with the relevant authorities. Member States are required to issue registration certificates to Union citizens under the conditions set out therein. Pursuant to that Directive, Member States are also required to issue residence cards to family members who are not nationals of a Member State and, on application, to issue documents certifying permanent residence and to issue permanent residence cards. (4) Directive 2004/38/EC provides that Member States may adopt the necessary measures to refuse, terminate or withdraw any right conferred by that Directive in the case of abuse of rights or fraud. Document forgery or false presentation of a material fact concerning the conditions attached to the right of residence have been identified as typical cases of fraud under that Directive. (5) Considerable differences exist between the security levels of national identity cards issued by Member States and residence permits for Union nationals residing in another Member State and their family members. Those differences increase the risk of falsification and document fraud and also give rise to practical difficulties for citizens when they wish to exercise their right of free movement. Statistics from the European Document Fraud Risk Analysis Network show that incidents of fraudulent identity cards have increased over time. (6) In its Communication of 14 September 2016 entitled \u2018Enhancing security in a world of mobility: improved information exchange in the fight against terrorism and stronger external borders\u2019, the Commission stressed that secure travel and identity documents are crucial whenever it is necessary to establish without doubt a person's identity, and announced that it would be presenting an action plan to tackle travel document fraud. According to that Communication, an improved approach relies on robust systems to prevent abuses and threats to internal security arising from failings in document security, in particular related to terrorism and cross-border crime. (7) According to the Commission's Action Plan of 8 December 2016 to strengthen the European response to travel document fraud (the 2016 Action Plan), at least three quarters of fraudulent documents detected at the external borders, but also in the area without controls at internal borders, purport to have been issued by Member States and the Schengen associated countries. Less secure national identity cards issued by Member States are the most frequently detected false documents used for intra-Schengen travel. (8) In order to deter identity fraud, Member States should ensure that the falsification and counterfeiting of identification documents and the use of such falsified or counterfeit documents are adequately penalised by their national law. (9) The 2016 Action Plan addressed the risk from fraudulent identity cards and residence documents. The Commission, in the 2016 Action Plan, and in its 2017 EU Citizenship Report, committed itself to analysing policy options to improve the security of identity cards and residence documents. (10) According to the 2016 Action Plan, issuing authentic and secure identity cards requires a reliable identity registration process and secure \u2018breeder\u2019 documents to support the application process. The Commission, the Member States and the relevant Union agencies should continue to work together to make breeder documents less vulnerable to fraud, given the increased use of false breeder documents. (11) This Regulation does not require Member States to introduce identity cards or residence documents where they are not provided for under national law, nor does it affect the competence of the Member States to issue, under national law, other residence documents which fall outside the scope of Union law, for example residence cards issued to all residents on the territory regardless of their nationality. (12) This Regulation does not prevent Member States from accepting, in a non-discriminatory manner, documents other than travel documents, for identification purposes, such as driving licences. (13) Identification documents issued to citizens whose rights of free movement have been restricted in accordance with Union or national law, and which expressly indicate that they cannot be used as travel documents, should not be considered as falling within the scope of this Regulation. (14) Travel documents compliant with part 5 of International Civil Aviation Organization (ICAO) Document 9303 on Machine Readable Travel Documents, (seventh edition, 2015) (\u2018ICAO Document 9303\u2019), which do not serve identification purposes in the issuing Member States, such as the passport card issued by Ireland, should not be considered as falling within the scope of this Regulation. (15) This Regulation does not affect the use of identity cards and residence documents with eID function by Member States for other purposes, nor does it affect the rules laid down in Regulation (EU) No 910/2014 of the European Parliament and of the Council (4), which provides for Union-wide mutual recognition of electronic identifications in access to public services and which helps citizens who are moving to another Member State, by requiring mutual recognition of electronic identification means subject to certain conditions. Improved identity cards should ensure easier identification and contribute to better access to services. (16) Proper verification of identity cards and residence documents requires that Member States use the correct title for each type of document covered by this Regulation. In order to facilitate the checking of documents covered by this Regulation in other Member States, the document title should also appear in at least one additional official language of the institutions of the Union. Where Member States already use, for identity cards, well-established designations other than the title \u2018identity card\u2019, they should be able to continue to do so in their official language or languages. However, no new designations should be introduced in the future. (17) Security features are necessary to verify if a document is authentic and to establish the identity of a person. The establishment of minimum security standards and the integration of biometric data in identity cards and in residence cards of family members who are not nationals of a Member State are important steps in rendering their use in the Union more secure. The inclusion of such biometric identifiers should allow Union citizens to fully benefit from their rights of free movement. (18) The storage of a facial image and two fingerprints (\u2018biometric data\u2019) on identity and residence cards, as already provided for in respect of biometric passports and residence permits for third-country nationals, represents an appropriate combination of reliable identification and authentication with a reduced risk of fraud, for the purpose of strengthening the security of identity and residence cards. (19) As a general practice, Member States should, for the verification of the authenticity of the document and the identity of the holder, primarily verify the facial image and, where necessary to confirm without doubt the authenticity of the document and the identity of the holder, Member States should also verify the fingerprints. (20) Members States should ensure that, in cases where a verification of biometric data does not confirm the authenticity of the document or the identity of its holder, a compulsory manual check is carried out by qualified staff. (21) This Regulation does not provide a legal basis for setting up or maintaining databases at national level for the storage of biometric data in Member States, which is a matter of national law that needs to comply with Union law regarding data protection. Moreover, this Regulation does not provide a legal basis for setting up or maintaining a centralised database at Union level. (22) Biometric identifiers should be collected and stored in the storage medium of identity cards and residence documents for the purposes of verifying the authenticity of the document and the identity of the holder. Such a verification should only be carried out by duly authorised staff and only when the document is required to be produced by law. Moreover, biometric data stored for the purpose of the personalisation of identity cards or residence documents should be kept in a highly secure manner and only until the date of collection of the document and, in any case, no longer than 90 days from the date of issue of the document. After that period, those biometric data should be immediately erased or destroyed. This should be without prejudice to any other processing of these data in accordance with Union and national law regarding data protection. (23) The specifications of ICAO Document 9303 which ensure global interoperability including in relation to machine readability and use of visual inspection should be taken into account for the purpose of this Regulation. (24) Member States should be able to decide whether to include a person's gender on a document covered by this Regulation. Where a Member State includes a person's gender on such a document, the specifications of ICAO Document 9303 \u2018F\u2019, \u2018M\u2019 or \u2018X\u2019 or the corresponding single initial used in the language or languages of that Member State should be used, as appropriate. (25) Implementing powers should be conferred on the Commission in order to ensure that future security standards and technical specifications adopted pursuant to Council Regulation (EC) No 1030/2002 (5) are duly taken into account, where appropriate, for identity cards and residence cards. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). To that end, the Commission should be assisted by the Committee established by Article 6 of Council Regulation (EC) No 1683/95 (7). Where necessary, it should be possible for the implementing acts adopted to remain secret in order to prevent the risk of counterfeiting and falsifications. (26) Member States should ensure that appropriate and effective procedures for the collection of biometric identifiers are in place and that such procedures comply with the rights and principles set out in the Charter, the Convention for the Protection of Human Rights and Fundamental Freedoms of the Council of Europe and the United Nations Convention on the Rights of the Child. Member States should ensure that the best interest of the child is a primary consideration throughout the collection procedure. To that end, qualified staff should receive appropriate training on child-friendly practices for the collecting of biometric identifiers. (27) Where difficulties are encountered in the collection of biometric identifiers, Member States should ensure that appropriate procedures are in place to respect the dignity of the person concerned. Therefore, specific considerations relating to gender, and to the specific needs of children and of vulnerable persons should be taken into account. (28) The introduction of minimum security and format standards for identity cards should allow Member States to rely on the authenticity of those documents when Union citizens exercise their right of free movement. The introduction of reinforced security standards should provide sufficient guarantees to public authorities and private entities to enable them to rely on the authenticity of identity cards when used by Union citizens for identification purposes. (29) A distinguishing sign in the form of the two-letter country code of the Member State issuing the document, printed in negative in a blue rectangle and encircled by 12 yellow stars, facilitates the visual inspection of the document, in particular when the holder is exercising the right of free movement. (30) While the option to provide for additional national features is maintained, Member States should ensure that those features do not diminish the efficiency of the common security features or negatively affect the cross-border compatibility of the identity cards, such as the capability that the identity cards can be read by machines used by Member States other than those which issue the identity cards. (31) The introduction of security standards in identity cards and in residence cards of family members who are not nationals of a Member State should not result in a disproportionate increase in fees for Union citizens or third-country nationals. Member States should take this principle into consideration when issuing calls for tender. (32) Member States should take all necessary steps to ensure that biometric data correctly identify the person to whom an identity card is issued. To this end, Member States could consider collecting biometric identifiers, particularly the facial image, by means of live enrolment by the national authorities issuing identity cards. (33) Member States should exchange with each other such information as is necessary to access, authenticate and verify the information contained on the secure storage medium. The formats used for the secure storage medium should be interoperable, including in respect of automated border crossing points. (34) Directive 2004/38/EC addresses the situation where Union citizens, or family members of Union citizens who are not nationals of a Member State, who do not have the necessary travel documents are to be given every reasonable opportunity to prove by other means that they are covered by the right of free movement. Such means can include identification documents used on a provisional basis and residence cards issued to such family members. (35) This Regulation respects the obligations set out in the Charter and in the United Nations Convention on the Rights of Persons with Disabilities. Therefore, Member States are encouraged to work with the Commission to integrate additional features that render identity cards more accessible and user-friendly to people with disabilities, such as visually impaired persons. Member States are to explore the use of solutions, such as mobile registration devices, for the issuance of identity cards to persons incapable of visiting the authorities responsible for issuing identity cards. (36) Residence documents issued to citizens of the Union should include specific information to ensure that they are identified as such in all Member States. This should facilitate the recognition of the Union citizen's use of the right of free movement and of the rights inherent to this use, but harmonisation should not go beyond what is appropriate to address the weaknesses of current documents. Member States are free to select the format in which these documents are issued and could issue them in a format complying with the specifications of ICAO Document 9303. (37) As regards residence documents issued to family members who are not nationals of a Member State, it is appropriate to make use of the same format and security features as those provided for in Regulation (EC) No 1030/2002 as amended by Regulation (EU) 2017/1954 of the European Parliament and of the Council (8). In addition to proving the right of residence, those documents also exempt their holders who are otherwise subject to a visa obligation from the requirement to obtain a visa when accompanying or joining the Union citizen within the Union territory. (38) Directive 2004/38/EC provides that documents issued to family members who are not nationals of a Member State are to be called \u2018Residence card of a family member of a Union citizen\u2019. In order to facilitate their identification, residence cards of a family member of a Union citizen should bear a standardised title and code. (39) Taking into account both the security risk and the costs incurred by Member States, identity cards as well as residence cards of a family member of a Union citizen with insufficient security standards should be phased out. In general, a phasing-out period of ten years for identity cards and five years for residence cards should be sufficient to strike a balance between the frequency with which documents are usually replaced and the need to fill the existing security gap within the Union. However, for cards which do not have important security features, or are not machine readable, a shorter phasing-out period is necessary on security grounds. (40) Regulation (EU) 2016/679 of the European Parliament and of the Council (9) applies with regard to the personal data to be processed in the context of the application of this Regulation. It is necessary to further specify safeguards applicable to the processed personal data and in particular to sensitive data such as biometric identifiers. Data subjects should be made aware of the existence in their documents of the storage medium containing their biometric data including its accessibility in contactless form as well as of all instances where the data contained in their identity cards and residence documents are used. In any case, data subjects should have access to personal data processed in their identity cards and residence documents and should have the right to have them rectified by way of issuance of a new document where such data is erroneous or incomplete. The storage medium should be highly secure and effectively protect personal data stored on it from unauthorised access. (41) Member States should be responsible for the proper processing of biometric data, from collection to integration of the data on the highly secure storage medium, in accordance with Regulation (EU) 2016/679. (42) Member States should exercise particular caution when cooperating with an external service provider. Such cooperation should not exclude any liability of the Member States arising under Union or national law for breaches of obligations with regard to personal data. (43) It is necessary to specify in this Regulation the basis for the collection and storage of data on the storage medium of identity cards and residence documents. In accordance with Union or national law and respecting the principles of necessity and proportionality, Member States should be able to store other data on a storage medium for electronic services or for other purposes relating to the identity card or residence document. The processing of such other data including their collection and the purposes for which they can be used should be authorised by Union or national law. All national data should be physically or logically separated from biometric data referred to in this Regulation and should be processed in accordance with Regulation (EU) 2016/679. (44) Member States should apply this Regulation at the latest 24 months after the date of its entry into force. As from the date of application of this Regulation, Member States should only issue documents which respect the requirements set out in this Regulation. (45) The Commission should report on the implementation of this Regulation two years, and 11 years, respectively, after its date of application, including on the appropriateness of the level of security, taking into account its impact on fundamental rights and data protection principles. In accordance with the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (10), the Commission should, six years after the date of application of this Regulation, and every six years thereafter, carry out an evaluation of this Regulation on the basis of information gathered through specific monitoring arrangements, in order to assess the actual effects of this Regulation and the need for any further action. For the purpose of monitoring, Member States should collect statistics on the number of identity cards and residence documents which they issued. (46) Since the objectives of this Regulation, namely to enhance security and to facilitate the exercise of the rights of free movement by Union citizens and their family members cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (47) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter including human dignity, the right to the integrity of the person, the prohibition of inhuman or degrading treatment, the right to equality before the law and non-discrimination, the rights of children, the rights of the elderly, respect for private and family life, the right to the protection of personal data, the right of free movement and the right to an effective remedy. Member States should comply with the Charter when implementing this Regulation. (48) The European Data Protection Supervisor and the Fundamental Rights Agency issued opinions on 10 August 2018 (11) and on 5 September 2018 (12) respectively, HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter This Regulation strengthens the security standards applicable to identity cards issued by Member States to their nationals and to residence documents issued by Member States to Union citizens and their family members when exercising their right to free movement. Article 2 Scope This Regulation applies to: (a) identity cards issued by Member States to their own nationals as referred to in Article 4(3) of Directive 2004/38/EC; This Regulation shall not apply to identification documents issued on a provisional basis with a period of validity of less than six months. (b) registration certificates issued in accordance with Article 8 of Directive 2004/38/EC to Union citizens residing for more than three months in a host Member State and documents certifying permanent residence issued in accordance with Article 19 of Directive 2004/38/EC to Union citizens upon application; (c) residence cards issued in accordance with Article 10 of Directive 2004/38/EC to family members of Union citizens who are not nationals of a Member State and permanent residence cards issued in accordance with Article 20 of Directive 2004/38/EC to family members of Union citizens who are not nationals of a Member State. CHAPTER II NATIONAL IDENTITY CARDS Article 3 Security standards/format/specifications 1. Identity cards issued by Member States shall be produced in ID-1 format and shall contain a machine-readable zone (MRZ). Such identity cards shall be based on the specifications and minimum security standards set out in ICAO Document 9303 and shall comply with the requirements set out in points (c), (d), (f) and (g) of the Annex to Regulation (EC) No 1030/2002 as amended by Regulation (EU) 2017/1954. 2. The data elements included on identity cards shall comply with the specifications set out in part 5 of ICAO document 9303. By way of derogation from the first subparagraph, the document number may be inserted in zone I and the designation of a person's gender shall be optional. 3. The document shall bear the title \u2018Identity card\u2019 or another well-established national designation in the official language or languages of the issuing Member State, and the words \u2018Identity card\u2019 in at least one other official language of the institutions of the Union. 4. The identity card shall contain, on the front side, the two-letter country code of the Member State issuing the card, printed in negative in a blue rectangle and encircled by 12 yellow stars. 5. Identity cards shall include a highly secure storage medium which shall contain a facial image of the holder of the card and two fingerprints in interoperable digital formats. For the capture of biometric identifiers, Member States shall apply the technical specifications as established by Commission Implementing Decision C(2018) 7767 (13). 6. The storage medium shall have sufficient capacity and capability to guarantee the integrity, the authenticity and the confidentiality of the data. The data stored shall be accessible in contactless form and secured as provided for in Implementing Decision C(2018) 7767. Member States shall exchange the information necessary to authenticate the storage medium and to access and verify the biometric data referred to in paragraph 5. 7. Children under the age of 12 years may be exempt from the requirement to give fingerprints. Children under the age of 6 years shall be exempt from the requirement to give fingerprints. Persons in respect of whom fingerprinting is physically impossible shall be exempt from the requirement to give fingerprints. 8. When necessary and proportionate to the aim to be achieved, Member States may enter such details and observations for national use as may be required in accordance with national law. The efficiency of minimum security standards and the cross-border compatibility of identity cards shall not be diminished as a result. 9. Where Member States incorporate a dual interface or a separate storage medium in the identity card, the additional storage medium shall comply with the relevant ISO standards and shall not interfere with the storage medium referred to in paragraph 5. 10. Where Member States store data for electronic services such as e-government and e-business in the identity cards, such national data shall be physically or logically separated from the biometric data referred to in paragraph 5. 11. Where Member States add additional security features to identity cards, the cross-border compatibility of such identity cards and the efficiency of the minimum security standards shall not be diminished as a result. Article 4 Period of validity 1. Identity cards shall have a minimum period of validity of five years and a maximum period of validity of ten years. 2. By way of derogation from paragraph 1, Member States may provide for a period of validity of: (a) less than five years, for identity cards issued to minors; (b) in exceptional cases, less than five years, for identity cards issued to persons in special and limited circumstances and where their period of validity is limited in compliance with Union and national law; (c) more than 10 years, for identity cards issued to persons aged 70 and above. 3. Member States shall issue an identity card having a validity of 12 months or less where it is temporarily physically impossible to take fingerprints of any of the fingers of the applicant. Article 5 Phasing out 1. Identity cards which do not meet the requirements set out in Article 3 shall cease to be valid at their expiry or by 3 August 2031, whichever is earlier. 2. By way of derogation from paragraph 1: (a) identity cards which do not meet the minimum security standards set out in part 2 of ICAO document 9303 or which do not include a functional MRZ, as defined in paragraph 3, shall cease to be valid at their expiry or by 3 August 2026, whichever is earlier; (b) identity cards of persons aged 70 and above at 2 August 2021, which meet the minimum security standards set out in part 2 of ICAO document 9303 and which have a functional MRZ, as defined in paragraph 3, shall cease to be valid at their expiry. 3. For the purpose of paragraph 2, a functional MRZ shall mean: (a) a machine-readable zone compliant with part 3 of ICAO document 9303; or (b) any other machine-readable zone for which the issuing Member State notifies the rules required for reading and displaying the information contained therein, unless a Member State notifies the Commission, by 2 August 2021, of its lack of capacity to read and display this information. Upon receipt of a notification as referred to in point (b) of the first subparagraph, the Commission shall inform the Member State concerned and the Council accordingly. CHAPTER III RESIDENCE DOCUMENTS FOR UNION CITIZENS Article 6 Minimum information to be indicated Residence documents when issued by Member States to Union citizens, shall indicate at a minimum the following: (a) the title of the document in the official language or languages of the Member State concerned and in at least one other official language of the institutions of the Union; (b) a clear reference that the document is issued to a Union citizen in accordance with Directive 2004/38/EC; (c) the document number; (d) the name (surname and forename(s)) of the holder; (e) the date of birth of the holder; (f) the information to be included on registration certificates and documents certifying permanent residence, issued in accordance with Articles 8 and 19 of Directive 2004/38/EC, respectively; (g) the issuing authority; (h) on the front-side, the two-letter country code of the Member State issuing the document, printed in negative in a blue rectangle and encircled by twelve yellow stars. If a Member State decides to take fingerprints, Article 3(7) shall apply accordingly. Persons in respect of whom fingerprinting is physically impossible shall be exempt from the requirement to give fingerprints. CHAPTER IV RESIDENCE CARDS FOR FAMILY MEMBERS WHO ARE NOT NATIONALS OF A MEMBER STATE Article 7 Uniform format 1. When issuing residence cards to family members of Union citizens who are not nationals of a Member State, Member States shall use the same format as established by Regulation (EC) No 1030/2002 as amended by Regulation (EU) 2017/1954, and as implemented by Implementing Decision C(2018) 7767. 2. By way of derogation from paragraph 1, a card shall bear the title \u2018Residence card\u2019 or \u2018Permanent residence card\u2019. Member States shall indicate that these documents are issued to a family member of a Union citizen in accordance with Directive 2004/38/EC. For this purpose, Member States shall use the standardised code \u2018Family Member EU Art 10 DIR 2004/38/EC\u2019 or \u2018Family Member EU Art 20 DIR 2004/38/EC\u2019, in data field [10], as referred to in the Annex to Regulation (EC) No 1030/2002 as amended by Regulation (EU) 2017/1954. 3. Member States may enter data for national use in accordance with national law. When entering and storing such data, Member States shall respect the requirements set out in the second paragraph of Article 4 of Regulation (EC) No 1030/2002 as amended by Regulation (EU) 2017/1954. Article 8 Phasing out of existing residence cards 1. Residence cards of family members of Union citizens who are not nationals of a Member State, which do not meet the requirements of Article 7 shall cease to be valid at their expiry or by 3 August 2026, whichever is earlier. 2. By way of derogation from paragraph 1, residence cards of family members of Union citizens who are not nationals of a Member State, which do not meet the minimum security standards set out in part 2 of ICAO document 9303 or which do not include a functional MRZ compliant with part 3 of ICAO document 9303, shall cease to be valid at their expiry or by 3 August 2023, whichever is earlier. CHAPTER V COMMON PROVISIONS Article 9 Contact point 1. Each Member State shall designate at least one central authority as a contact point for the implementation of this Regulation. Where a Member State has designated more than one central authority, it shall designate which of those authorities will be the contact point for the implementation of this Regulation. It shall communicate the name of that authority to the Commission and the other Member States. If a Member State changes its designated authority, it shall inform the Commission and the other Member States accordingly. 2. Member States shall ensure that the contact points are aware of relevant information and assistance services at Union level included in the Single Digital Gateway set out in Regulation (EU) 2018/1724 of the European Parliament and of the Council (14) and that they are able to cooperate with such services. Article 10 Collection of biometric identifiers 1. The biometric identifiers shall be collected solely by qualified and duly authorised staff designated by the authorities responsible for issuing identity cards or residence cards, for the purpose of being integrated into the highly secure storage medium provided for in Article 3(5) for identity cards and in Article 7(1) for residence cards. By way of derogation from the first sentence, fingerprints shall be collected solely by qualified and duly authorised staff of such authorities, except in the case of applications submitted to the diplomatic and consular authorities of the Member State. With a view to ensuring the consistency of biometric identifiers with the identity of the applicant, the applicant shall appear in person at least once during the issuance process for each application. 2. Member States shall ensure that appropriate and effective procedures for the collection of biometric identifiers are in place and that those procedures comply with the rights and principles set out in the Charter, the Convention for the Protection of Human Rights and Fundamental Freedoms and the United Nations Convention on the Rights of the Child. Where difficulties are encountered in the collection of biometric identifiers, Member States shall ensure that appropriate procedures are in place to respect the dignity of the person concerned. 3. Other than where required for the purpose of processing in accordance with Union and national law, biometric identifiers stored for the purpose of personalisation of identity cards or residence documents shall be kept in a highly secure manner and only until the date of collection of the document and, in any case, no longer than 90 days from the date of issue. After this period, these biometric identifiers shall be immediately erased or destroyed. Article 11 Protection of personal data and liability 1. Without prejudice to Regulation (EU) 2016/679, Member States shall ensure the security, integrity, authenticity and confidentiality of the data collected and stored for the purpose of this Regulation. 2. For the purpose of this Regulation, the authorities responsible for issuing identity cards and residence documents shall be considered as the controller referred to in Article 4(7) of Regulation (EU) 2016/679 and shall have responsibility for the processing of personal data. 3. Member States shall ensure that supervisory authorities can fully exercise their tasks as referred to in Regulation (EU) 2016/679, including access to all personal data and all necessary information as well as access to any premises or data processing equipment of the competent authorities. 4. Cooperation with external service providers shall not exclude any liability on the part of a Member State which may arise under Union or national law in respect of breaches of obligations with regard to personal data. 5. Information in machine-readable form shall only be included in an identity card or residence document in accordance with this Regulation and the national law of the issuing Member State. 6. Biometric data stored in the storage medium of identity cards and residence documents shall only be used in accordance with Union and national law, by the duly authorised staff of competent national authorities and Union agencies, for the purpose of verifying: (a) the authenticity of the identity card or residence document; (b) the identity of the holder by means of directly available comparable features where the identity card or residence document is required to be produced by law. 7. Member States shall maintain, and communicate annually to the Commission, a list of the competent authorities with access to the biometric data stored on the storage medium referred to in Article 3(5) of this Regulation. The Commission shall publish online a compilation of such national lists. Article 12 Monitoring By 2 August 2020, the Commission shall establish a detailed programme for monitoring the outputs, results and impact of this Regulation, including its impact on fundamental rights. The monitoring programme shall set out the means by which and the intervals at which the data and other necessary evidence are to be collected. It shall specify the action to be taken by the Commission and by Member States in collecting and analysing the data and other evidence. Member States shall provide the Commission with the data and other evidence necessary for such monitoring. Article 13 Reporting and Evaluation 1. Two years, and 11 years, respectively, after the date of application of this Regulation, the Commission shall report to the European Parliament, to the Council and to the European Economic and Social Committee on its implementation, in particular on the protection of fundamental rights and personal data. 2. Six years after the date of application of this Regulation, and every subsequent six years, the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament, to the Council and to the European Economic and Social Committee. The report shall in particular focus on: (a) the impact of this Regulation on fundamental rights; (b) the mobility of Union citizens; (c) the effectiveness of biometric verification in ensuring the security of travel documents; (d) a possible use of residence cards as travel documents; (e) a possible further visual harmonisation of identity cards; (f) the necessity of introducing common security features of identification documents used on a provisional basis in view of their better recognition. 3. Member States and relevant Union agencies shall provide the Commission with the information necessary for the preparation of these reports. Article 14 Additional technical specifications 1. In order to ensure, where appropriate, that identity cards and residence documents referred to in points (a) and (c) of Article 2 comply with future minimum security standards, the Commission shall establish, by means of implementing acts, additional technical specifications, relating to the following: (a) additional security features and requirements, including enhanced anti-forgery, counterfeiting and falsification standards; (b) technical specifications for the storage medium of the biometric features referred to in Article 3(5) and their security, including prevention of unauthorised access and facilitation of validation; (c) requirements for quality and common technical standards for the facial image and the fingerprints. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2). 2. In accordance with the procedure referred to in Article 15(2), it may be decided that the specifications referred to in this Article are to be secret and are not to be published. In such a case, they shall be made available only to the bodies designated by the Member States as responsible for printing and to persons duly authorised by a Member State or by the Commission. 3. Each Member State shall designate one body having responsibility for printing identity cards, and one body having responsibility for printing residence cards of family members of Union citizens, and shall communicate the names of such bodies to the Commission and to the other Member States. Member States shall be entitled to change such designated bodies and shall inform the Commission and the other Member States accordingly. Member States may also decide to designate a single body having responsibility for printing both identity cards and residence cards of family members of Union citizens and shall communicate the name of this body to the Commission and to the other Member States. Two or more Member States may also decide to designate a single body for those purposes and shall inform the Commission and the other Member States accordingly. Article 15 Committee procedure 1. The Commission shall be assisted by the Committee established by Article 6 of Regulation (EC) No 1683/95. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee does not deliver an opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 16 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 2 August 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 367, 10.10.2018, p. 78. (2) Position of the European Parliament of 4 April 2019 (not yet published in the Official Journal) and decision of the Council of 6 June 2019. (3) Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77). (4) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73). (5) Council Regulation (EC) No 1030/2002 of 13 June 2002 laying down a uniform format for residence permits for third-country nationals (OJ L 157, 15.6.2002, p. 1). (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) Council Regulation (EC) No 1683/95 of 29 May 1995 laying down a uniform format for visas (OJ L 164, 14.7.1995, p. 1). (8) Regulation (EU) 2017/1954 of the European Parliament and of the Council of 25 October 2017 amending Council Regulation (EC) No 1030/2002 laying down a uniform format for residence permits for third-country nationals (OJ L 286, 1.11.2017, p. 9). (9) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (10) OJ L 123, 12.5.2016, p. 1. (11) OJ C 338, 21.9.2018, p. 22. (12) Not yet published. (13) Commission Implementing Decision C(2018) 7767 of 30 November 2018 laying down the technical specifications for the uniform format for residence permits for third country nationals and repealing Decision C(2002) 3069. (14) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).", "summary": "Security of identity cards and residence documents Security of identity cards and residence documents SUMMARY OF: Regulation (EU) 2019/1157 \u2014 strengthening the security of identity cards and of residence documents issued to EU citizens and their family members exercising their right of free movement WHAT IS THE AIM OF THE REGULATION? It strengthens the security of identity cards EU countries issue to their own nationals and of residence documents they provide other EU citizens and their family members. It introduces minimum standards for the information contained on the cards and the security features all EU countries issuing such documents must apply. KEY POINTS Scope The regulation applies to: identity cards, except for provisional documents valid for less than 6 months, EU countries issue to their own nationals; registration certificates for EU citizens living in another EU country for more than 3 months and residence documents for those there permanently; residence cards and permanent residence cards for EU citizens\u2019 family members who are not EU nationals. Identity cards Identity cards must be produced in ID-1 format, contain a machine-readable zone (MRZ) and meet certain specifications and security standards, including: the size, layout and content (name, sex, nationality, date of birth, optional personal features, document number and expiry date) requirements of International Civil Aviation Organization Document (ICAO) 9303;the title \u2018identity card\u2019 or another well-established national designation in the official language of the issuing EU country, and the words \u2018identity card\u2019 in at least one other official EU language;the two-letter code of the issuing EU country inside the EU flag on the front;a highly secure storage medium containing the holder\u2019s facial image and 2 fingerprints children under 6 are exempt from fingerprints andchildren between 6 and 12 may be exempted;other details and observations required by national law. They are valid for a minimum of 5 and a maximum of 10 years. EU countries: may limit this to less than 5 years in exceptional cases and for minors;may extend this to over 10 years for people aged 70 and above;must restrict validity to 12 months or less when it is temporarily physically impossible to take an applicant\u2019s fingerprints. Those currently in circulation will no longer be valid on their expiry date: or at the latest by 3 August 2031 if they do not meet the new requirements;or at the latest by 3 August 2026 if they do not meet the minimum security standards of Part 2 of ICAO Document 9303 or include a functional MRZ;if issued to people aged 70 and over and meet the ICAO security and MRZ requirements. Residence documents issued to EU citizens must, as a minimum, contain: the document\u2019s title in the EU country\u2019s official language(s); a clear reference that they are issued according to Directive 2004/38/EC (see summary on EU freedom of movement and residence); document number; holder\u2019s surname and forename(s); holder\u2019s date of birth; the information to be included on registration certificates and documents certifying permanent residence; issuing authority; the 2-letter code of the issuing EU country inside the EU flag on the front. Residence cards for family members who are non-EU nationals: must use the uniform format established by Regulation (EC) No 1030/2002 as amended by Regulation (EU) 2017/1954 and Implementing Decision C(2018) 7767; and have the title \u2018Residence Card\u2019 or \u2018Permanent residence card\u2019 according to Directive 2004/38/EC and the standardised code \u2018Family Member EU Art 10 DIR 2004/38/EC\u2019 or \u2018Family Member EU Art 20 DIR 2004/38/EC\u2019; currently in circulation will no longer be valid on their expiry date or by 3 August 2026, whichever is earlier. Cards that do not meet minimum security standards or include a functional MRZ will no longer be valid on their expiry date or by 3 August 2023, whichever is earlier. EU countries: establish at least one central authority as a contact point to implement the legislation; apply appropriate and effective procedures to collect biometric identifiers by qualified and duly authorised staff. These must comply with the EU Charter of Fundamental Rights, the Convention for the Protection of Human Rights and Fundamental Freedoms and the United Nations Convention on the Rights of the Child; provide appropriate procedures that respect the dignity of the person concerned if difficulties arise when biometric identifiers are collected; ensure the security, integrity, authenticity and confidentiality of the data collected and stored; are responsible for the erasure or destruction of biometric identifiers once the document is collected or, at the latest, 90 days after it is issued. The European Commission: establishes, by 2 August 2020, a detailed programme to monitor the outputs, results and impact of the legislation, including on fundamental rights; reports to the European Parliament, the Council and the European Economic and Social Committee (EESC) on the legislation\u2019s impact, especially on protection of fundamental rights and personal data, 2 and 11 years after it takes effect; evaluates application of the legislation for the European Parliament, the Council and the EESC 6 years after it takes effect, and after that at 6-yearly intervals, focusing on: impact on fundamental rightsmobility of EU citizenseffectiveness of biometric verification for security of travel documentspossible use of residence cards as travel documentspossible further visual harmonisation of identity cardsneed to introduce common security features for provisional identification documents; adopts implementing acts on additional technical specifications required by the regulation. FROM WHEN DOES THE REGULATION APPLY? It applies from 2 August 2021. From this date, all new identity and residence documents must meet the new criteria. BACKGROUND The combination of increased travel and fragmented regulations makes the security of identity documents a key element in the fight against terrorism, organised crime and identity theft. The regulation is part of the Commission\u2019s 2016 action plan to tackle travel document fraud. This called for measures to improve the security of documents such as identity and residence cards, particularly in the light of recent terrorist attacks. The regulation does not require EU countries to introduce identity cards or to make the holding of an identity card compulsory. Nor does it prevent them from using other documents, such as driving licences, for domestic identification purposes. MAIN DOCUMENT Regulation (EU) 2019/1157 of the European Parliament and of the Council of 20 June 2019 on strengthening the security of identity cards of Union citizens and of residence documents issued to Union citizens and their family members exercising their right of free movement (OJ L 188, 12.7.2019, pp. 67-78) RELATED DOCUMENTS Commission Implementing Decision of 30.11.2018 laying down the technical specifications for the uniform format for residence permits for third country nationals and repealing Decision C(2002)3069 Communication from the Commission to the European Parliament and the Council \u2014 Action plan to strengthen the European response to travel document fraud (COM(2016) 790 final, 8.12.2016) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) Successive amendments to Regulation (EU) 2016/679 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, pp. 73-114) Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, pp. 77-123). Text republished in corrigendum (OJ L 229, 29.6.2004, p. 35-48) See consolidated version. Council Regulation (EC) No 1030/2002 of 13 June 2002 laying down a uniform format for residence permits for third-country nationals (OJ L 157, 15.6.2002, pp. 1-7) See consolidated version. Council Regulation (EC) No 1683/95 of 29 May 1995 laying down a uniform format for visas (OJ L 164, 14.7.1995, pp. 1-4) See consolidated version. last update 21.10.2019"}
{"article": "22.5.2019 EN Official Journal of the European Union L 135/1 REGULATION (EU) 2019/816 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty of the Functioning of the European Union, and in particular Article 82(1), second subparagraph, point (d) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) The Union has set itself the objective of offering its citizens an area of freedom, security and justice without internal frontiers, in which the free movement of persons is ensured. That objective should be achieved by means of, among others, appropriate measures to prevent and combat crime, including organised crime and terrorism. (2) That objective requires that information on convictions handed down in the Member States be taken into account outside the convicting Member State in the course of new criminal proceedings, as laid down in Council Framework Decision 2008/675/JHA (2), as well as in order to prevent new offences. (3) That objective presupposes the exchange of information extracted from criminal records between the competent authorities of the Member States. Such an exchange of information is organised and facilitated by the rules set out in Council Framework Decision 2009/315/JHA (3) and by the European Criminal Records Information System (ECRIS), established by Council Decision 2009/316/JHA (4). (4) The existing ECRIS legal framework, however, does not sufficiently address the particularities of requests concerning third-country nationals. Although it is already possible to exchange information on third-country nationals through ECRIS, there is no common Union procedure or mechanism in place to do so efficiently, rapidly and accurately. (5) Within the Union, information on third-country nationals is not gathered as it is for nationals of Member States \u2014 in the Member States of nationality \u2014 but only stored in the Member States where the convictions have been handed down. A complete overview of the criminal history of a third-country national can therefore be ascertained only if such information is requested from all Member States. (6) Such \u2018blanket requests\u2019 impose a disproportionate administrative burden on all Member States, including those not holding information on the particular third-country national. In practice, that burden deters Member States from requesting information on third-country nationals from other Member States, which seriously hinders the exchange of information between them, limiting their access to criminal records information to information stored in their national register. As a consequence, the risk of information exchange between Member States being inefficient and incomplete is increased, which in turn affects the level of security and safety provided to citizens and persons residing within the Union. (7) To improve the situation, a system should be established by which the central authority of a Member State can find out promptly and efficiently which other Member States hold criminal records information on a third-country national (\u2018ECRIS-TCN\u2019). The existing ECRIS framework could then be used to request the criminal records information from those Member States in accordance with Framework Decision 2009/315/JHA. (8) This Regulation should therefore lay down rules establishing a centralised system at the Union level containing personal data, and rules on the division of responsibilities between the Member State and the organisation responsible for the development and maintenance of the centralised system, as well as any specific data protection provisions needed to supplement the existing data protection arrangements and to provide for an adequate overall level of data protection, data security and protection of the fundamental rights of the persons concerned. (9) The objective of offering to citizens of the Union an area of freedom, security and justice without internal frontiers, in which the free movement of persons is ensured, also requires complete information to be held on convictions of citizens of the Union who also hold the nationality of a third country. Given the possibility that those persons could present themselves as holding one or several nationalities, and that different convictions could be stored in the convicting Member State or in the Member State of nationality, it is necessary to include citizens of the Union who also hold the nationality of a third country within the scope of this Regulation. The exclusion of such persons would result in the information stored in ECRIS-TCN being incomplete. That would jeopardise the reliability of the system. However, since such persons hold Union citizenship, the conditions under which fingerprint data can be included in ECRIS-TCN in respect of those persons should be comparable to the conditions under which the fingerprint data of Union citizens are exchanged between Member States through ECRIS, which was established by Framework Decision 2009/315/JHA and Decision 2009/316/JHA. Therefore, in respect of citizens of the Union who also hold the nationality of a third country, fingerprint data should only be included in ECRIS-TCN where they have been collected in accordance with national law during criminal proceedings, it being understood that for such inclusion Member States should be able to use fingerprint data collected for purposes other than criminal proceedings, where such use is permitted under national law. (10) ECRIS-TCN should allow for processing of fingerprint data for the purpose of identifying the Member States in possession of criminal records information on a third-country national. It should also allow for processing of facial images in order to confirm his or her identity. It is essential that the entry and use of fingerprint data and facial images not exceed what is strictly necessary to achieve the aim, respect fundamental rights, as well as the best interests of children, and be in conformity with applicable Union data protection rules. (11) The European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) established by Regulation (EU) 2018/1726 of the European Parliament and of the Council (5) should be entrusted with the task of developing and operating ECRIS-TCN, given its experience with managing other large scale systems in the area of justice and home affairs. Its mandate should be amended to reflect those new tasks. (12) eu-LISA should be equipped with the appropriate funding and staffing to meet its responsibilities under this Regulation. (13) Given the need to create close technical links between ECRIS-TCN and ECRIS, eu-LISA should also be entrusted with the task of further developing and maintaining the ECRIS reference implementation, and its mandate should be amended to reflect this. (14) Four Member States have developed their own national ECRIS implementation software in accordance with Decision 2009/316/JHA, and have been using it instead of the ECRIS reference implementation to exchange criminal records information. Given the particular features that those Member States have introduced in their systems for national use and the investments that they have made, they should be allowed to use their national ECRIS implementation software for the purposes of ECRIS-TCN as well, provided that the conditions set out in this Regulation are met. (15) ECRIS-TCN should contain only the identity information of third-country nationals convicted by a criminal court within the Union. Such identity information should include alphanumeric and fingerprint data. It should also be possible for facial images to be included in as far as the law of the Member State where a conviction is handed down allows for the collection and storage of facial images of a convicted person. (16) The alphanumeric data to be entered by the Member States into the central system should include the surname (family name) and the first names (given names) of the convicted person, as well as, where such information is available to the central authority, any pseudonyms or aliases of that person. If differing personal data, such as a different spelling of a name in another alphabet, are known to the Member State concerned, it should be possible to enter such data into the central system as additional information. (17) The alphanumeric data should also include, as additional information, the identity number, or the type and number of the person's identification documents, as well as the name of the authority issuing those documents, where such information is available to the central authority. The Member State should seek to verify the authenticity of identification documents before entering the relevant information in the central system. In any case, given that such information could be unreliable, it should be used cautiously. (18) The central authorities should use ECRIS-TCN to identify the Member States holding criminal records information on a third-country national when criminal records information on that person is requested in the Member State concerned for the purposes of criminal proceedings against that person, or for the purposes referred to in this Regulation. While ECRIS-TCN should in principle be used in all such cases, the authority responsible for conducting the criminal proceedings should be able to decide that ECRIS-TCN should not be used when it would not be appropriate in the circumstances of the case, e.g. in certain types of urgent criminal proceedings, in cases of transit, when criminal records information has recently been obtained via ECRIS, or in respect of minor offences, in particular minor traffic offences, minor offences in relation to general municipal regulations and minor public order offences. (19) Member States should also be able to use ECRIS-TCN for purposes other than those set out in this Regulation, if provided for under and in accordance with national law. However, in order to enhance the transparency of the use of ECRIS-TCN, Member States should notify such other purposes to the Commission, which should ensure publication of all the notifications in the Official Journal of the European Union. (20) It should also be possible for other authorities requesting criminal records information to decide that ECRIS-TCN should not be used when this would not be appropriate in the circumstances of the case, e.g. when certain standard administrative checks need to be carried out regarding the professional qualifications of a person, especially if it is known that criminal records information will not be requested from other Member States, irrespective of the result of the search in ECRIS-TCN. However, ECRIS-TCN should always be used when the request for criminal records information has been initiated by a person who asks for information on his or her own criminal record in accordance with Framework Decision 2009/315/JHA, or when it is made in order to obtain criminal records information in accordance with Directive 2011/93/EU of the European Parliament and of the Council (6). (21) Third-country nationals should have the right to obtain information in writing concerning their own criminal record in accordance with the law of the Member State where they request such information to be provided and in accordance with Framework Decision 2009/315/JHA. Before providing such information to a third-country national, the Member State concerned should query ECRIS-TCN. (22) Citizens of the Union who also hold the nationality of a third country will only be included in ECRIS-TCN if the competent authorities are aware that such persons hold the nationality of a third country. Where the competent authorities are not aware that citizens of the Union also hold the nationality of a third country, it is nevertheless possible that such persons have prior convictions as third-country nationals. In order to ensure that the competent authorities have a complete overview of criminal records, it should be possible to query ECRIS-TCN to verify whether, in respect of a citizen of the Union, any Member State holds criminal record information concerning this person as a third-country national. (23) In the event that there is a match between data recorded in the central system and those used for search by a Member State (hit), the identity information against which a hit was recorded should be provided together with the hit. The result of a search should be used by the central authorities only for the purpose of making a request through ECRIS or by the European Union Agency for Criminal Justice Cooperation (Eurojust) established by Regulation (EU) 2018/1727 of the European Parliament and of the Council (7), the European Union Agency for Law Enforcement Cooperation (Europol) established by Regulation (EU) 2016/794 of the European Parliament and of the Council (8), and the European Public Prosecutor's Office (the \u2018EPPO\u2019) established by Council Regulation (EU) 2017/1939 (9), only for the purpose of making a request for conviction information as referred to in this Regulation. (24) In the first instance, facial images included in ECRIS-TCN should only be used for the purpose of confirming the identity of a third-country national in order to identify the Member States holding information on previous convictions of that third-country national. In the future, it should be possible for facial images to be used for automated biometric matching, provided that the technical and policy requirements to do so have been met. The Commission, taking into account necessity and proportionality, as well as the technical developments in the field of facial recognition software, should assess the availability and readiness of the required technology before adopting a delegated act concerning the use of facial images for the purpose of identifying third-country nationals in order to identify the Member States holding information on previous convictions concerning those persons. (25) The use of biometrics is necessary as it is the most reliable method of identifying third-country nationals within the territory of the Member States, who are often not in possession of documents or any other means of identification, as well as for more reliable matching of third-country nationals' data. (26) Member States should enter in the central system fingerprint data of convicted third-country nationals that have been collected in accordance with national law during criminal proceedings. In order to have as complete identity information as possible available in the central system, Member States should also be able to enter into the central system fingerprint data that have been collected for other purposes than criminal proceedings, where those fingerprint data are available for use in criminal proceedings in compliance with national law. (27) This Regulation should establish minimum criteria as regards the fingerprint data that Member States should include in the central system. Member States should be given the choice either to enter the fingerprint data of third-country nationals who have received a custodial sentence of at least 6 months, or to enter the fingerprint data of third-country nationals who have been convicted of a criminal offence which is punishable under the law of the Member State concerned by a custodial sentence of a maximum period of at least 12 months. (28) Member States should create records in ECRIS-TCN regarding convicted third-country nationals. This should, where possible, be done automatically and without undue delay after their conviction was entered into the national criminal records. Member States should, in accordance with this Regulation, enter into the central system alphanumeric and fingerprint data relating to convictions handed down after the date of the start of entry of data into the ECRIS-TCN. As from the same date, and any time thereafter, Member States should be able to enter facial images in the central system. (29) Member States should also, in accordance with this Regulation, create records in ECRIS-TCN regarding third-country nationals convicted prior to the date of start of entry of data, in order to ensure the maximum effectiveness of the system. However, for that purpose Member States should not be obliged to collect information which is not already in their criminal records prior to the date of start of entry of data. The fingerprint data of third-country nationals collected in connection with such prior convictions should be included only where they have been collected during criminal proceedings, and where the Member State concerned considers that they can be clearly matched with other identity information in criminal records. (30) Improving the exchange of information on convictions should assist Member States in their implementation of Framework Decision 2008/675/JHA, which obliges the Member States to take account of previous convictions in other Member States in the course of new criminal proceedings to the extent that previous national convictions are taken into account under national law. (31) A hit indicated by ECRIS-TCN should not of itself be taken to mean that the third-country national concerned has been convicted in the Member States that are indicated. The existence of previous convictions should only be confirmed based on information received from the criminal records of the Member States concerned. (32) Notwithstanding the possibility of using the Union's financial programmes in accordance with the applicable rules, each Member State should bear its own costs arising from the implementation, administration, use and maintenance of its criminal records database and national fingerprints databases, and from the implementation, administration, use and maintenance of the technical alterations necessary to be able to use ECRIS-TCN, including their connections to the national central access point. (33) Eurojust, Europol and the EPPO should have access to ECRIS-TCN for the purpose of identifying the Member States holding criminal records information on a third-country national in order to support their statutory tasks. Eurojust should also have direct access to ECRIS-TCN for the purpose of carrying out its task under this Regulation of acting as a contact point for third countries and international organisations, without prejudice to the application of principles of judicial cooperation in criminal matters, including rules on mutual legal assistance. While the position of Member States who are not part of the enhanced cooperation on the establishment of the EPPO should be taken into account, the EPPO should not be refused access to conviction information on the sole ground that the Member State concerned is not part of that enhanced cooperation. (34) This Regulation establishes strict rules on access to ECRIS-TCN and the necessary safeguards, including the responsibility of the Member States in collecting and using the data. It also sets out how individuals may exercise their rights to compensation, access, rectification, erasure and redress, in particular the right to an effective remedy and the supervision of processing operations by public independent authorities. It therefore respects fundamental rights and freedoms enshrined, in particular, in the Charter of Fundamental Rights of the European Union, including the right to protection of personal data, the principle of equality before the law and the general prohibition of discrimination. In this regard, it also takes into account the European Convention for the Protection of Human Rights and Fundamental Freedoms, the International Covenant on Civil and Political Rights, and other human rights obligations under international law. (35) Directive (EU) 2016/680 of the European Parliament and of the Council (10) should apply to the processing of personal data by competent national authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security. Regulation (EU) 2016/679 of the European Parliament and of the Council (11) should apply to the processing of personal data by national authorities when such processing does not fall within the scope of Directive (EU) 2016/680. Coordinated supervision should be ensured in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (12), which should also apply to the processing of personal data by eu-LISA. (36) In respect of prior convictions, the central authorities should enter alphanumeric data by the end of the period for entry of data under this Regulation, and fingerprint data within two years after the date of the start of operations of ECRIS-TCN. Member States should be able to enter all data at the same time, provided those time limits are met. (37) Rules should be laid down on the liability of the Member States, Eurojust, Europol, the EPPO and eu-LISA in respect of damage arising from any breach of this Regulation. (38) In order to improve identification of the Member States holding information on previous convictions of third-country nationals, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of supplementing this Regulation by providing for the use of facial images for the purpose of identifying third-country nationals in order to identify the Member States holding information on previous convictions. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (39) In order to ensure uniform conditions for the establishment and operational management of ECRIS-TCN, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and the Council (14). (40) Member States should take the necessary measures to comply with this Regulation as soon as possible so as to ensure the proper functioning of ECRIS-TCN, taking into account the time that eu-LISA needs to develop and implement ECRIS-TCN. However, Member States should have at least 36 months after the entry into force of this Regulation to take measures to comply with this Regulation. (41) Since the objective of this Regulation, namely to enable the rapid and efficient exchange of accurate criminal records information on third-country nationals, cannot be sufficiently achieved by the Member States, but can rather, by putting in place common rules, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (42) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (43) In accordance with Articles 1 and 2 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, Ireland is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (44) In accordance with Article 3 and Article 4a(1) of Protocol No 21, the United Kingdom has notified its wish to take part in the adoption and application of this Regulation. (45) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (15) and delivered an opinion on 12 December 2017 (16), HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject matter This Regulation establishes: (a) a system to identify the Member States holding information on previous convictions of third-country nationals (\u2018ECRIS-TCN\u2019); (b) the conditions under which ECRIS-TCN shall be used by the central authorities in order to obtain information on such previous convictions through the European Criminal Records Information System (ECRIS) established by Decision 2009/316/JHA, as well as the conditions under which Eurojust, Europol and the EPPO shall use ECRIS-TCN. Article 2 Scope This Regulation applies to the processing of identity information of third-country nationals who have been subject to convictions in the Member States for the purpose of identifying the Member States where such convictions were handed down. With the exception of point (b)(ii) of Article 5(1), the provisions of this Regulation that apply to third-country nationals also apply to citizens of the Union who also hold the nationality of a third country and who have been subject to convictions in the Member States. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018conviction\u2019 means any final decision of a criminal court against a natural person in respect of a criminal offence, to the extent that the decision is entered in the criminal records of the convicting Member State; (2) \u2018criminal proceedings\u2019 means the pre-trial stage, the trial stage and the execution of the conviction; (3) \u2018criminal record\u2019 means the national register or registers recording convictions in accordance with national law; (4) \u2018convicting Member State\u2019 means the Member State in which a conviction is handed down; (5) \u2018central authority\u2019 means an authority designated in accordance with Article 3(1) of Framework Decision 2009/315/JHA; (6) \u2018competent authorities\u2019 means the central authorities and Eurojust, Europol and the EPPO, which are competent to access or query ECRIS-TCN in accordance with this Regulation; (7) \u2018third-country national\u2019 means a person who is not a citizen of the Union within the meaning of Article 20(1) TFEU, or who is a stateless person or a person whose nationality is unknown; (8) \u2018central system\u2019 means the database or databases developed and maintained by eu-LISA which hold identity information on third-country nationals who have been subject to convictions in the Member States; (9) \u2018interface software\u2019 means the software hosted by the competent authorities allowing them to access the central system through the communication infrastructure referred to in point (d) of Article 4(1); (10) \u2018identity information\u2019 means alphanumeric data, fingerprint data and facial images that are used to establish a connection between these data and a natural person; (11) \u2018alphanumeric data\u2019 means data represented by letters, digits, special characters, spaces and punctuation marks; (12) \u2018fingerprint data\u2019 means the data relating to plain and rolled impressions of the fingerprints of each of a person's fingers; (13) \u2018facial image\u2019 means a digital image of a person's face; (14) \u2018hit\u2019 means a match or matches established by comparison between identity information recorded in the central system and the identity information used for a search; (15) \u2018national central access point\u2019 means the national connection point to the communication infrastructure referred to in point (d) of Article 4(1); (16) \u2018ECRIS reference implementation\u2019 means the software developed by the Commission and made available to the Member States for the exchange of criminal records information through ECRIS; (17) \u2018national supervisory authority\u2019 means an independent public authority which is established by a Member State pursuant to applicable Union data protection rules; (18) \u2018supervisory authorities\u2019 means the European Data Protection Supervisor and the national supervisory authorities. Article 4 Technical architecture of ECRIS-TCN 1. ECRIS-TCN shall be composed of: (a) a central system in which identity information on convicted third-country nationals is stored; (b) a national central access point in each Member State; (c) interface software enabling the connection of the competent authorities to the central system via the national central access points and the communication infrastructure referred to in point (d); (d) a communication infrastructure between the central system and the national central access points. 2. The central system shall be hosted by eu-LISA at its technical sites. 3. The interface software shall be integrated with the ECRIS reference implementation. The Member States shall use the ECRIS reference implementation or, in the situation and under the conditions set out in paragraphs 4 to 8, the national ECRIS implementation software to query ECRIS-TCN and to send subsequent requests for criminal records information. 4. The Member States which use their national ECRIS implementation software shall be responsible for ensuring that their national ECRIS implementation software allows their national criminal records authorities to use ECRIS-TCN, with the exception of the Interface Software, in accordance with this Regulation. For that purpose, they shall, before the date of start of operations of ECRIS-TCN in accordance with Article 35(4), ensure that their national ECRIS implementation software functions in accordance with the protocols and technical specifications established in the implementing acts referred to in Article 10, and with any further technical requirements established by eu-LISA pursuant to this Regulation based on those implementing acts. 5. For as long as they do not use the ECRIS reference implementation, Member States which use their national ECRIS implementation software shall also ensure the implementation of any subsequent technical adaptations to their national ECRIS implementation software required by any changes to the technical specifications established in the implementing acts referred to in Article 10, or changes to any further technical requirements established by eu-LISA pursuant to this Regulation based on those implementing acts, without undue delay. 6. The Member States which use their national ECRIS implementation software shall bear all the costs associated with the implementation, maintenance and further development of their national ECRIS implementation software and its interconnection with ECRIS-TCN, with the exception of the interface software. 7. If a Member State which uses its national ECRIS implementation software is unable to comply with its obligations under this Article, it shall be obliged to use the ECRIS reference implementation, including the integrated interface software, to make use of ECRIS-TCN. 8. In view of the assessment to be carried out by the Commission pursuant to point (b) of Article 36(10), the Member States concerned shall provide the Commission with all necessary information. CHAPTER II Entry and use of data by central authorities Article 5 Data entry in ECRIS-TCN 1. For each convicted third-country national, the central authority of the convicting Member State shall create a data record in the central system. The data record shall include: (a) as concerns alphanumeric data: (i) information to be included unless, in individual cases, such information is not known to the central authority (obligatory information): \u2014 surname (family name), \u2014 first names (given names), \u2014 date of birth, \u2014 place of birth (town and country), \u2014 nationality or nationalities, \u2014 gender, \u2014 previous names, if applicable, \u2014 the code of the convicting Member State, (ii) information to be included if it has been entered in the criminal record (optional information): \u2014 parents' names, (iii) information to be included if it is available to the central authority (additional information): \u2014 identity number, or the type and number of the person's identification documents, as well as the name of the issuing authority, \u2014 pseudonyms or aliases; (b) as concerns fingerprint data: (i) fingerprint data that have been collected in accordance with national law during criminal proceedings; (ii) as a minimum, fingerprint data collected on the basis of either of the following criteria: \u2014 where the third-country national has received a custodial sentence of at least 6 months; or \u2014 where the third-country national has been convicted of a criminal offence which is punishable under the law of the Member State by a custodial sentence of a maximum period of at least 12 months. 2. The fingerprint data referred to in point (b) of paragraph 1 of this Article shall have the technical specifications for the quality, resolution and processing of fingerprint data provided for in the implementing act referred to in point (b) of Article 10(1). The reference number of the fingerprint data of the convicted person shall include the code of the convicting Member State. 3. The data record may also contain facial images of the convicted third-country national, if the law of the convicting Member State allows for the collection and storage of facial images of convicted persons. 4. The convicting Member State shall create the data record automatically, where possible, and without undue delay after the conviction has been entered into the criminal records. 5. The convicting Member States shall also create data records for convictions handed down prior to the date of start of entry of data in accordance with Article 35(1) to the extent that data related to convicted persons are stored in their national databases. In those cases, fingerprint data shall be included only where they have been collected during criminal proceedings in accordance with national law, and where they can be clearly matched with other identity information in criminal records. 6. In order to comply with the obligations set out in points (b)(i) and (ii) of paragraph 1, and in paragraph 5, Member States may use fingerprint data collected for purposes other than criminal proceedings, where such use is permitted under national law. Article 6 Facial images 1. Until the entry into force of the delegated act provided for in paragraph 2, facial images may be used only to confirm the identity of a third-country national who has been identified as a result of an alphanumeric search or a search using fingerprint data. 2. The Commission is empowered to adopt delegated acts in accordance with Article 37 supplementing this Regulation concerning the use of facial images for the purpose of identifying third-country nationals in order to identify the Member States holding information on previous convictions concerning such persons, when it becomes technically possible. Before exercising this empowerment, the Commission, taking into account necessity and proportionality, as well as technical developments in the field of facial recognition software, shall assess the availability and readiness of the required technology. Article 7 Use of ECRIS-TCN for identifying the Member States holding criminal records information 1. The central authorities shall use ECRIS-TCN to identify the Member States holding criminal records information on a third-country national in order to obtain information on previous convictions through ECRIS, when criminal records information on that person is requested in the Member State concerned for the purposes of criminal proceedings against that person, or for any of the following purposes, if provided for under and in accordance with national law: \u2014 checking a person's own criminal record at his or her request, \u2014 security clearance, \u2014 obtaining a licence or permit, \u2014 employment vetting, \u2014 vetting for voluntary activities involving direct and regular contacts with children or vulnerable persons, \u2014 visa, acquisition of citizenship and migration procedures, including asylum procedures, and \u2014 checks in relation with public contracts and public examinations. However, in specific cases other than those in which a third-country national asks the central authority for information on his or her own criminal record, or where the request is made in order to obtain criminal records information pursuant to Article 10(2) of Directive 2011/93/EU, the authority requesting criminal records information may decide that such use of ECRIS-TCN is not appropriate. 2. Any Member State which decides, if provided for under and in accordance with national law, to use ECRIS-TCN for purposes other than those set out in paragraph 1 in order to obtain information on previous convictions through ECRIS, shall, by the date of start of operations as referred to in Article 35(4), or any time thereafter, notify the Commission of such other purposes and any changes to such purposes. The Commission shall publish such notifications in the Official Journal of the European Union within 30 days of receipt of the notifications. 3. Eurojust, Europol and the EPPO are entitled to query ECRIS-TCN to identify the Member States holding criminal records information on a third-country national in accordance with Articles 14 to 18. However, they shall not enter, rectify or erase any data in ECRIS-TCN. 4. For the purposes referred to in paragraphs 1, 2 and 3, the competent authorities may also query ECRIS-TCN to verify whether, in respect of a citizen of the Union, any Member State holds criminal records information concerning this person as a third-country national. 5. When querying ECRIS-TCN, the competent authorities may use all or only some of the data referred to in Article 5(1). The minimum set of data that is required to query the system shall be specified in an implementing act adopted in accordance with point (g) of Article 10(1). 6. The competent authorities may also query ECRIS-TCN using facial images, provided that such functionality has been implemented in accordance with Article 6(2). 7. In the event of a hit, the central system shall automatically provide the competent authority with information on the Member States holding criminal records information on the third-country national, along with the associated reference numbers and any corresponding identity information. Such identity information shall only be used for the purpose of verifying the identity of the third-country national concerned. The result of a search in the central system may only be used for the purpose of making a request according to Article 6 of Framework Decision 2009/315/JHA or a request referred to in Article 17(3) of this Regulation. 8. In the event that there is no hit, the central system shall automatically inform the competent authority. CHAPTER III Retention and modification of the data Article 8 Retention period for data storage 1. Each data record shall be stored in the central system for as long as the data related to the convictions of the person concerned are stored in the criminal records. 2. Upon expiry of the retention period referred to in paragraph 1, the central authority of the convicting Member State shall erase the data record, including any fingerprint data or facial images, from the central system. The erasure shall be done automatically, where possible, and in any event no later than one month after the expiry of the retention period. Article 9 Modification and erasure of data 1. The Member States may modify or erase the data which they have entered into ECRIS-TCN. 2. Any modification of the information in the criminal records which led to the creation of a data record in accordance with Article 5 shall include identical modification of the information stored in that data record in the central system by the convicting Member State without undue delay. 3. If a convicting Member State has reason to believe that the data it has recorded in the central system are inaccurate or that data were processed in the central system in contravention of this Regulation, it shall: (a) immediately launch a procedure for checking the accuracy of the data concerned or the lawfulness of its processing, as appropriate; (b) if necessary, rectify the data or erase them from the central system without undue delay. 4. If a Member State other than the convicting Member State which entered the data has reason to believe that data recorded in the central system are inaccurate or that data were processed in the central system in contravention of this Regulation, it shall contact the central authority of the convicting Member State without undue delay. The convicting Member State shall: (a) immediately launch a procedure for checking the accuracy of the data concerned or the lawfulness of its processing, as appropriate; (b) if necessary, rectify the data or erase them from the central system without undue delay; (c) inform the other Member State that the data have been rectified or erased, or of the reasons why the data have not been rectified or erased, without undue delay. CHAPTER IV Development, operation and responsibilities Article 10 Adoption of implementing acts by the Commission 1. The Commission shall adopt the implementing acts necessary for the technical development and implementation of ECRIS-TCN as soon as possible, and in particular acts concerning: (a) the technical specifications for the processing of the alphanumeric data; (b) the technical specifications for the quality, resolution and processing of fingerprint data; (c) the technical specifications of the interface software; (d) the technical specifications for the quality, resolution and processing of facial images for the purposes of and under the conditions set out in Article 6; (e) data quality, including a mechanism for and procedures to carry out data quality checks; (f) entering the data in accordance with Article 5; (g) accessing and querying ECRIS-TCN in accordance with Article 7; (h) modifying and erasing the data in accordance with Articles 8 and 9; (i) keeping and accessing logs in accordance with Article 31; (j) operation of the central repository and the data security and data protection rules applicable to the repository, in accordance with Article 32; (k) providing statistics in accordance with Article 32; (l) performance and availability requirements of ECRIS-TCN, including minimal specifications and requirements on the biometric performance of ECRIS-TCN in particular in terms of the required false positive identification rate and false negative identification rate. 2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 38(2). Article 11 Development and operational management of ECRIS \u2014 TCN 1. eu-LISA shall be responsible for the development of ECRIS-TCN in accordance with the principle of data protection by design and by default. In addition, eu-LISA shall be responsible for the operational management of ECRIS-TCN. The development shall consist of the elaboration and implementation of the technical specifications, testing and overall project coordination. 2. eu-LISA shall also be responsible for the further development and maintenance of the ECRIS reference implementation. 3. eu-LISA shall define the design of the physical architecture of ECRIS-TCN including its technical specifications and evolution as regards the central system, the national central access point and the interface software. That design shall be adopted by its Management Board, subject to a favourable opinion of the Commission. 4. eu-LISA shall develop and implement ECRIS-TCN as soon as possible after the entry into force of this Regulation and following the adoption by the Commission of the implementing acts provided for in Article 10. 5. Prior to the design and development phase of ECRIS-TCN, the Management Board of eu-LISA shall establish a Programme Management Board composed of ten members. The Programme Management Board shall be composed of eight members appointed by the Management Board, the Chair of the Advisory Group referred to in Article 39 and one member appointed by the Commission. The members appointed by the Management Board shall be elected only from those Member States which are fully bound under Union law by the legislative instruments governing ECRIS and which will participate in ECRIS-TCN. The Management Board shall ensure that the members it appoints to the Programme Management Board have the necessary experience and expertise in the development and management of IT systems supporting judicial and criminal records authorities. eu-LISA shall participate in the work of the Programme Management Board. To that end, representatives of eu-LISA shall attend the meetings of the Programme Management Board in order to report on work regarding the design and development of ECRIS-TCN and on any other related work and activities. The Programme Management Board shall meet at least once every three months, and more often when necessary. It shall ensure the adequate management of the design and development phase of ECRIS-TCN and shall ensure consistency between central and national ECRIS-TCN projects, and national ECRIS implementation software. The Programme Management Board shall submit written reports regularly and if possible every month to the Management Board of eu-LISA on the progress of the project. The Programme Management Board shall have no decision-making power nor any mandate to represent the members of the Management Board. 6. The Programme Management Board shall establish its rules of procedure which shall include in particular rules on: (a) chairmanship; (b) meeting venues; (c) preparation of meetings; (d) admission of experts to the meetings; (e) communication plans ensuring that non-participating Members of the Management Board are kept fully informed. 7. The chairmanship of the Programme Management Board shall be held by a Member State which is fully bound under Union law by the legislative instruments governing ECRIS and the legislative instruments governing the development, establishment, operation and use of all the large-scale IT systems managed by eu-LISA. 8. All travel and subsistence expenses incurred by the members of the Programme Management Board shall be paid by eu-LISA. Article 10 of the eu-LISA Rules of Procedure shall apply mutatis mutandis. The Programme Management Board's secretariat shall be ensured by eu-LISA. 9. During the design and development phase, the Advisory Group referred to in Article 39 shall be composed of the national ECRIS-TCN project managers and chaired by eu-LISA. During the design and development phase it shall meet regularly, if possible at least once a month, until the start of operations of ECRIS-TCN. It shall report after each meeting to the Programme Management Board. It shall provide the technical expertise to support the tasks of the Programme Management Board and shall follow up on the state of preparation of the Member States. 10. In order to ensure the confidentiality and integrity of data stored in ECRIS-TCN at all times, eu-LISA shall, in cooperation with the Member States, provide for appropriate technical and organisational measures, taking into account the state of the art, the cost of implementation and the risks posed by the processing. 11. eu-LISA shall be responsible for the following tasks related to the communication infrastructure referred to in point (d) of Article 4(1): (a) supervision; (b) security; (c) the coordination of relations between the Member States and the provider of the communication infrastructure. 12. The Commission shall be responsible for all other tasks relating to the communication infrastructure referred to in point (d) of Article 4(1), in particular: (a) tasks relating to the implementation of the budget; (b) acquisition and renewal; (c) contractual matters. 13. eu-LISA shall develop and maintain a mechanism and procedures for carrying out quality checks on the data stored in ECRIS-TCN and shall provide regular reports to the Member States. eu-LISA shall provide regular reports to the Commission covering the issues encountered and the Member States concerned. 14. The operational management of ECRIS-TCN shall consist of all the tasks necessary to keep ECRIS-TCN operational in accordance with this Regulation, and in particular the maintenance work and technical developments necessary to ensure that ECRIS-TCN functions at a satisfactory level in accordance with the technical specifications. 15. eu-LISA shall perform tasks related to providing training on the technical use of ECRIS-TCN and the ECRIS reference implementation. 16. Without prejudice to Article 17 of the Staff Regulations of Officials of the European Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (17), eu-LISA shall apply appropriate rules of professional secrecy or other equivalent duties of confidentiality to its entire staff required to work with data registered in the central system. That obligation shall also apply after such staff leave office or employment or after the termination of their activities. Article 12 Responsibilities of the Member States 1. Each Member State shall be responsible for: (a) ensuring a secure connection between its national criminal records and fingerprints databases and the national central access point; (b) the development, operation and maintenance of the connection referred to in point (a); (c) ensuring a connection between its national systems and the ECRIS reference implementation; (d) the management of and arrangements for access of duly authorised staff of the central authorities to ECRIS-TCN in accordance with this Regulation and for establishing and regularly updating a list of such staff and the profiles referred to in point (g) of Article 19(3). 2. Each Member State shall give the staff of its central authority who have a right to access ECRIS-TCN appropriate training covering, in particular, data security and data protection rules and applicable fundamental rights, before authorising them to process data stored in the central system. Article 13 Responsibility for the use of data 1. In accordance with applicable Union data protection rules, each Member State shall ensure that the data recorded in ECRIS-TCN are processed lawfully, and in particular that: (a) only duly authorised staff have access to the data for the performance of their tasks; (b) the data are collected lawfully in a manner that fully respects the human dignity and fundamental rights of the third-country national; (c) the data are entered into ECRIS-TCN lawfully; (d) the data are accurate and up-to-date when they are entered into ECRIS-TCN. 2. eu-LISA shall ensure that ECRIS-TCN is operated in accordance with this Regulation, with the delegated act referred to in Article 6(2) and with the implementing acts referred to in Article 10, as well as in accordance with Regulation (EU) 2018/1725. In particular, eu-LISA shall take the necessary measures to ensure the security of the central system and the communication infrastructure referred to in point (d) of Article 4(1), without prejudice to the responsibilities of each Member State. 3. eu-LISA shall inform the European Parliament, the Council and the Commission as well as the European Data Protection Supervisor as soon as possible of the measures it takes pursuant to paragraph 2 in view of the start of operations of ECRIS-TCN. 4. The Commission shall make the information referred to in paragraph 3 available to the Member States and to the public through a regularly updated public website. Article 14 Access for Eurojust, Europol, and the EPPO 1. Eurojust shall have direct access to ECRIS-TCN for the purpose of the implementation of Article 17, as well as for fulfilling its tasks under Article 2 of Regulation (EU) 2018/1727, in order to identify the Member States holding information on previous convictions of third-country nationals. 2. Europol shall have direct access to ECRIS-TCN for the purpose of fulfilling its tasks under points (a) to (e) and (h) of Article 4(1) of Regulation (EU) 2016/794, in order to identify the Member States holding information on previous convictions of third-country nationals. 3. The EPPO shall have direct access to ECRIS-TCN for the purpose of fulfilling its tasks under Article 4 of Regulation (EU) 2017/1939, in order to identify the Member States holding information on previous convictions of third-country nationals. 4. Following a hit indicating the Member States holding criminal records information on a third-country national, Eurojust, Europol, and the EPPO may use their respective contacts with the national authorities of those Member States to request the criminal records information in the manner provided for in their respective founding acts. Article 15 Access by authorised staff of Eurojust, Europol and the EPPO Eurojust, Europol and the EPPO shall be responsible for the management of and arrangements for access of duly authorised staff to ECRIS-TCN in accordance with this Regulation and for establishing and regularly updating a list of such staff and their profiles. Article 16 Responsibilities of Eurojust, Europol and the EPPO Eurojust, Europol and the EPPO shall: (a) establish the technical means to connect to ECRIS-TCN and be responsible for maintaining that connection; (b) provide appropriate training covering, in particular, data security and data protection rules and applicable fundamental rights to those members of their staff who have a right to access ECRIS-TCN before authorising them to process data stored in the central system; (c) ensure that the personal data processed by them under this Regulation is protected in accordance with the applicable data protection rules. Article 17 Contact point for third countries and international organisations 1. Third countries and international organisations may, for the purposes of criminal proceedings, address requests for information on which Member States, if any, hold criminal records information on a third-country national to Eurojust. To that end, they shall use the standard form set out in the Annex to this Regulation. 2. When Eurojust receives a request under paragraph 1, it shall use ECRIS-TCN to identify which Member States, if any, hold criminal records information on the third-country national concerned. 3. If there is a hit, Eurojust shall ask the Member State that holds criminal records information on the third-country national concerned whether it consents to Eurojust informing the third country or the international organisation of the name of the Member State concerned. Where that Member State gives its consent, Eurojust shall inform the third country or the international organisation of the name of that Member State, and of how it can introduce a request for extracts from the criminal records with that Member State in accordance with the applicable procedures. 4. In cases where there is no hit or where Eurojust cannot provide an answer in accordance with paragraph 3 to requests made under this Article, it shall inform the third country or international organisation concerned that it has completed the procedure, without providing any indication of whether criminal records information on the person concerned is held by one of the Member States. Article 18 Providing information to a third country, international organisation or private party Neither Eurojust, Europol, the EPPO nor any central authority shall transfer or make available to a third country, an international organisation or a private party information obtained from ECRIS-TCN concerning a third-country national. This Article shall be without prejudice to Article 17(3). Article 19 Data Security 1. eu-LISA shall take the necessary measures to ensure the security of ECRIS-TCN, without prejudice to the responsibilities of each Member State, taking the security measures specified in paragraph 3 into consideration. 2. As regards the operation of ECRIS-TCN, eu-LISA shall take the necessary measures in order to achieve the objectives set out in paragraph 3, including the adoption of a security plan and a business continuity and disaster recovery plan, and to ensure that installed systems may, in case of interruption, be restored. 3. The Member States shall ensure the security of the data before and during the transmission to and receipt from the national central access point. In particular, each Member State shall: (a) physically protect data, including by making contingency plans for the protection of infrastructure; (b) deny unauthorised persons access to national installations in which the Member State carries out operations related to ECRIS-TCN; (c) prevent the unauthorised reading, copying, modification or removal of data media; (d) prevent the unauthorised input of data and the unauthorised inspection, modification or erasure of stored personal data; (e) prevent the unauthorised processing of data in ECRIS-TCN and any unauthorised modification or erasure of data processed in ECRIS-TCN; (f) ensure that persons authorised to access ECRIS-TCN have access only to the data covered by their access authorisation, by means of individual user identities and confidential access modes only; (g) ensure that all authorities with a right of access to ECRIS-TCN create profiles describing the functions and responsibilities of persons who are authorised to enter, rectify, erase, consult and search the data and make their profiles available to the national supervisory authorities without undue delay at their request; (h) ensure that it is possible to verify and establish to which Union bodies, offices and agencies personal data may be transmitted using data communication equipment; (i) ensure that it is possible to verify and establish what data have been processed in ECRIS-TCN, when, by whom and for what purpose; (j) prevent the unauthorised reading, copying, modification or erasure of personal data during the transmission of personal data to or from ECRIS-TCN or during the transport of data media, in particular by means of appropriate encryption techniques; (k) monitor the effectiveness of the security measures referred to in this paragraph and take the necessary organisational measures related to self-monitoring and supervision to ensure compliance with this Regulation. 4. eu-LISA and the Member States shall cooperate in order to ensure a coherent data security approach based on a security risk management process encompassing the entire ECRIS-TCN. Article 20 Liability 1. Any person who, or any Member State which, has suffered material or non-material damage as a result of an unlawful processing operation or any other act incompatible with this Regulation shall be entitled to receive compensation from: (a) the Member State which is responsible for the damage suffered; or (b) eu-LISA, where eu-LISA has not complied with its obligations set out in this Regulation or in Regulation (EU) 2018/1725. The Member State which is responsible for the damage suffered or eu-LISA, respectively, shall be exempted from liability, in whole or in part, if it proves that it is not responsible for the event which gave rise to the damage. 2. If any failure of a Member State, Eurojust, Europol, or the EPPO to comply with its obligations under this Regulation causes damage to ECRIS-TCN, that Member State, Eurojust, Europol, or the EPPO, respectively, shall be held liable for such damage, unless and insofar as eu-LISA or another Member State participating in ECRIS-TCN failed to take reasonable measures to prevent the damage from occurring or to minimise its impact. 3. Claims for compensation against a Member State for the damage referred to in paragraphs 1 and 2 shall be governed by the law of the defendant Member State. Claims for compensation against eu-LISA, Eurojust, Europol and the EPPO for the damage referred to in paragraphs 1 and 2 shall be governed by their respective founding acts. Article 21 Self-monitoring Member States shall ensure that each central authority takes the measures necessary to comply with this Regulation and cooperates, where necessary, with the supervisory authorities. Article 22 Penalties Any misuse of data entered in ECRIS-TCN shall be subject to penalties or disciplinary measures, in accordance with national or Union law, that are effective, proportionate and dissuasive. CHAPTER V Data protection rights and supervision Article 23 Data controller and data processor 1. Each central authority is to be considered as data controller in accordance with applicable Union data protection rules for the processing of the personal data by that central authority's Member State under this Regulation. 2. eu-LISA shall be considered as data processor in accordance with Regulation (EU) 2018/1725 as regards the personal data entered into the central system by the Member States. Article 24 Purpose of the processing of personal data 1. The data entered into the central system shall only be processed for the purpose of the identification of the Member States holding the criminal records information on third-country nationals. 2. With the exception of duly authorised staff of Eurojust, Europol and the EPPO who have access to ECRIS-TCN for the purposes of this Regulation, access to ECRIS-TCN shall be reserved exclusively to duly authorised staff of the central authorities. Access shall be limited to the extent needed for the performance of the tasks in accordance with the purpose referred to in paragraph 1, and to what is necessary and proportionate to the objectives pursued. Article 25 Right of access, rectification, erasure and restriction of processing 1. The requests of third-country nationals concerning the rights of access to personal data, to rectification and erasure and to restriction of processing of personal data which are set out in the applicable Union data protection rules may be addressed to the central authority of any Member State. 2. Where a request is made to a Member State other than the convicting Member State, the Member State to which the request has been made shall forward it to the convicting Member State without undue delay and in any event within 10 working days of receiving the request. Upon receipt of the request, the convicting Member State shall: (a) immediately launch a procedure for checking the accuracy of the data concerned and the lawfulness of its processing in ECRIS-TCN; and (b) respond to the Member State that forwarded the request without undue delay. 3. In the event that data recorded in ECRIS-TCN are inaccurate or have been processed unlawfully, the convicting Member State shall rectify or erase the data in accordance with Article 9. The convicting Member State or, where applicable, the Member State to which the request has been made shall confirm in writing to the person concerned without undue delay that action has been taken to rectify or erase data relating to that person. The convicting Member State shall also without undue delay inform any other Member State which has been a recipient of conviction information obtained as a result of a query of ECRIS-TCN of what action has been taken. 4. If the convicting Member State does not agree that data recorded in ECRIS-TCN are inaccurate or have been processed unlawfully, that Member State shall adopt an administrative or judicial decision explaining in writing to the person concerned why it is not prepared to rectify or erase data relating to him or her. Such cases may, where appropriate, be communicated to the national supervisory authority. 5. The Member State which has adopted the decision pursuant to paragraph 4 shall also provide the person concerned with information explaining the steps which that person can take if the explanation given pursuant to paragraph 4 is not acceptable to him or her. This shall include information on how to bring an action or a complaint before the competent authorities or courts of that Member State and any assistance, including from the national supervisory authorities, that is available in accordance with the national law of that Member State. 6. Any request made pursuant to paragraph 1 shall contain the information necessary to identify the person concerned. That information shall be used exclusively to enable the exercise of the rights referred to in paragraph 1 and shall be erased immediately afterwards. 7. Where paragraph 2 applies, the central authority to whom the request was addressed shall keep a written record that such a request was made and of how it was addressed and to which authority it was forwarded. Upon request from the national supervisory authority, the central authority shall make that record available to that national supervisory authority without delay. The central authority and the national supervisory authority shall erase such records three years after their creation. Article 26 Cooperation to ensure respect for data protection rights 1. The central authorities shall cooperate with each other in order to ensure respect for the rights laid down in Article 25. 2. In each Member State, the national supervisory authority shall, upon request, provide information to the person concerned on how to exercise his or her right to rectify or erase data relating to him or to her, in accordance with the applicable Union data protection rules. 3. For the purposes of this Article, the national supervisory authority of the Member State which transmitted the data and the national supervisory authority of the Member State to which the request has been made shall cooperate with each other. Article 27 Remedies Any person shall have the right to lodge a complaint and the right to a legal remedy in the convicting Member State which refused the right of access to or the right of rectification or erasure of data relating to him or to her, referred to in Article 25 in accordance with national or Union law. Article 28 Supervision by the national supervisory authorities 1. Each Member State shall ensure that the national supervisory authorities designated pursuant to applicable Union data protection rules shall monitor the lawfulness of the processing of personal data referred to in Articles 5 and 6 by the Member State concerned, including their transmission to and from ECRIS-TCN. 2. The national supervisory authority shall ensure that an audit of the data processing operations in the national criminal records and fingerprints databases related to the data exchange between those systems and ECRIS-TCN is carried out in accordance with relevant international auditing standards at least every three years from the date of the start of operations of ECRIS-TCN. 3. Member States shall ensure that their national supervisory authorities have sufficient resources to fulfil the tasks entrusted to them under this Regulation. 4. Each Member State shall supply any information requested by its national supervisory authorities and shall, in particular, provide them with information on the activities carried out in accordance with Articles 12, 13 and 19. Each Member State shall grant its national supervisory authorities access to its records pursuant to Article 25(7) and to its logs pursuant to Article 31(6) and allow them access at all times to all its ECRIS-TCN related premises. Article 29 Supervision by the European Data Protection Supervisor 1. The European Data Protection Supervisor shall monitor that the personal data processing activities of eu-LISA concerning ECRIS-TCN are carried out in accordance with this Regulation. 2. The European Data Protection Supervisor shall ensure that an audit of eu-LISA's personal data processing activities is carried out in accordance with relevant international auditing standards at least every three years. A report of that audit shall be sent to the European Parliament, the Council, the Commission, eu-LISA and the supervisory authorities. eu-LISA shall be given an opportunity to make comments before the report is adopted. 3. eu-LISA shall supply information requested by the European Data Protection Supervisor, give him or her access to all documents and to its logs referred to in Article 31 and allow him or her access to all of its premises at any time. Article 30 Cooperation among national supervisory authorities and the European Data Protection Supervisor Coordinated supervision of ECRIS-TCN shall be ensured in accordance with Article 62 of Regulation (EU) 2018/1725. Article 31 Keeping of logs 1. eu-LISA and the competent authorities shall ensure, in accordance with their respective responsibilities, that all data processing operations in ECRIS-TCN are logged in accordance with paragraph 2 for the purposes of checking the admissibility of requests, monitoring data integrity and security and the lawfulness of the data processing as well as for the purposes of self-monitoring. 2. The log shall show: (a) the purpose of the request for access to ECRIS-TCN data; (b) the data transmitted as referred to in Article 5; (c) the national file reference; (d) the date and exact time of the operation; (e) the data used for a query; (f) the identifying mark of the official who carried out the search. 3. The log of consultations and disclosures shall make it possible to establish the justification of such operations. 4. Logs shall be used only for monitoring the lawfulness of data processing and for ensuring data integrity and security. Only logs containing non-personal data may be used for the monitoring and evaluation referred to in Article 36. Those logs shall be protected by appropriate measures against unauthorised access and erased after three years, if they are no longer required for monitoring procedures which have already begun. 5. On request, eu-LISA shall make the logs of its processing operations available to the central authorities without undue delay. 6. The competent national supervisory authorities responsible for checking the admissibility of the requests and monitoring the lawfulness of the data processing and data integrity and security shall have access to logs at their request for the purpose of fulfilling their duties. On request, the central authorities shall make the logs of their processing operations available to the competent national supervisory authorities without undue delay. CHAPTER VI Final provisions Article 32 Use of data for reporting and statistics 1. The duly authorised staff of eu-LISA, of the competent authorities and of the Commission shall have access to the data processed within ECRIS-TCN solely for the purposes of reporting and providing statistics, without allowing for individual identification. 2. For the purpose of paragraph 1, eu-LISA shall establish, implement and host a central repository at its technical sites containing the data referred to in paragraph 1 which, without allowing for individual identification, enables customisable reports and statistics to be obtained. Access to the central repository shall be granted by means of secured access with control of access and specific user profiles, solely for the purpose of reporting and statistics. 3. The procedures put in place by eu-LISA to monitor the functioning of ECRIS-TCN referred to in Article 36 as well as the ECRIS reference implementation shall include the possibility to produce regular statistics for monitoring purposes. Every month eu-LISA shall submit to the Commission statistics relating to the recording, storage and exchange of information extracted from criminal records through ECRIS-TCN and the ECRIS reference implementation. eu-LISA shall ensure that it is not possible to identify individuals on the basis of those statistics. At the request of the Commission, eu-LISA shall provide it with statistics on specific aspects related to the implementation of this Regulation. 4. The Member States shall provide eu-LISA with the statistics necessary to fulfil its obligations referred to in this Article. They shall provide the Commission with statistics on the number of convicted third-country nationals, as well as the number of convictions of third-country nationals on their territory. Article 33 Costs 1. The costs incurred in connection with the establishment and operation of the central system, the communication infrastructure referred to in point (d) of Article 4(1), the interface software and the ECRIS reference implementation shall be borne by the general budget of the Union. 2. The costs of connection of Eurojust, Europol and the EPPO to ECRIS-TCN shall be borne by their respective budgets. 3. Other costs shall be borne by the Member States, specifically the costs incurred by the connection of the existing national criminal records registers, fingerprints databases and the central authorities to ECRIS-TCN, as well as the costs of hosting the ECRIS reference implementation. Article 34 Notifications 1. Each Member State shall notify eu-LISA of its central authority, or authorities, that has access to enter, rectify, erase, consult or search data, as well as of any change in this respect. 2. eu-LISA shall ensure publication of the list of central authorities notified by the Member States, both in the Official Journal of the European Union and on its website. When eu-LISA receives notification of a change to a Member State's central authority, it shall update the list without undue delay. Article 35 Entry of data and start of operations 1. Once the Commission is satisfied that the following conditions are met, it shall determine the date from which the Member States shall start entering the data referred to in Article 5 into ECRIS-TCN: (a) the relevant implementing acts referred to in Article 10 have been adopted; (b) the Member States have validated the technical and legal arrangements to collect and transmit the data referred to in Article 5 to ECRIS-TCN and have notified them to the Commission; (c) eu-LISA has carried out a comprehensive test of ECRIS-TCN, in cooperation with the Member States, using anonymous test data. 2. When the Commission has determined the date of start of entry of data in accordance with paragraph 1, it shall communicate that date to the Member States. Within a period of two months following that date, the Member States shall enter the data referred to in Article 5 into ECRIS-TCN, taking account of Article 41(2). 3. After the end of the period referred to in paragraph 2, eu-LISA shall carry out a final test of ECRIS-TCN, in cooperation with the Member States. 4. When the test referred to in paragraph 3 has been successfully completed and eu-LISA considers that ECRIS-TCN is ready to start operations, it shall notify the Commission. The Commission shall inform the European Parliament and the Council of the results of the test and shall decide on the date on which ECRIS-TCN is to start operations. 5. The decision of the Commission on the date of the start of operations of ECRIS-TCN, as referred to in paragraph 4, shall be published in the Official Journal of the European Union. 6. The Member States shall start using ECRIS-TCN from the date determined by the Commission in accordance with paragraph 4. 7. When taking the decisions referred to in this Article, the Commission may specify different dates for the entry into ECRIS-TCN of alphanumeric data and fingerprint data as referred to in Article 5, as well as for the start of operations with respect to those different categories of data. Article 36 Monitoring and evaluation 1. eu-LISA shall ensure that procedures are in place to monitor the development of ECRIS-TCN in light of objectives relating to planning and costs and to monitor the functioning of ECRIS-TCN and the ECRIS reference implementation in light of objectives relating to the technical output, cost-effectiveness, security and quality of service. 2. For the purposes of monitoring the functioning of ECRIS-TCN and its technical maintenance, eu-LISA shall have access to the necessary information relating to the data processing operations performed in ECRIS-TCN and in the ECRIS reference implementation. 3. By 12 December 2019 and every six months thereafter during the design and development phase, eu-LISA shall submit a report to the European Parliament and the Council on the state of play of the development of ECRIS-TCN and of the ECRIS reference implementation. 4. The report referred to in paragraph 3 shall include an overview of the current costs and the progress of the project, a financial impact assessment, and information on any technical problems and risks that may impact the overall costs of ECRIS-TCN to be borne by the general budget of the Union in accordance with Article 33. 5. In the event of substantial delays in the development process, eu-LISA shall inform the European Parliament and the Council as soon as possible of the reasons for these delays and of their impact in terms of time and finances. 6. Once the development of ECRIS-TCN and of the ECRIS reference implementation is finalised, eu-LISA shall submit a report to the European Parliament and to the Council explaining how the objectives, in particular relating to planning and costs, were achieved and justifying any divergences. 7. In the event of a technical upgrade of ECRIS-TCN which could result in substantial costs, eu-LISA shall inform the European Parliament and the Council. 8. Two years after the start of operations of ECRIS-TCN and every year thereafter, eu-LISA shall submit to the Commission a report on the technical functioning of ECRIS-TCN and of the ECRIS reference implementation, including their security, based in particular on the statistics on the functioning and use of ECRIS-TCN and on the exchange, through the ECRIS reference implementation, of information extracted from the criminal records. 9. Four years after the start of operations of ECRIS-TCN and every four years thereafter, the Commission shall conduct an overall evaluation of ECRIS-TCN and of the ECRIS reference implementation. The overall evaluation report established on this basis shall include an assessment of the application of this Regulation and an examination of results that have been achieved relative to the objectives that were set and of the impact on fundamental rights. The report shall also include an assessment of whether the underlying rationale for operating ECRIS-TCN continues to hold, of the appropriateness of the use of biometric data for the purposes of ECRIS-TCN, of the security of ECRIS-TCN and of any security implications for future operations. The evaluation shall include any necessary recommendations. The Commission shall transmit the report to the European Parliament, the Council, the European Data Protection Supervisor and the European Union Agency for Fundamental Rights. 10. In addition, the first overall evaluation as referred to in paragraph 9 shall include an assessment of: (a) the extent to which, on the basis of relevant statistical data and further information from the Member States, the inclusion in ECRIS-TCN of identity information of citizens of the Union who also hold the nationality of a third country has contributed to the achievement of the objectives of this Regulation; (b) the possibility, for some Member States, to continue the use of national ECRIS implementation software, as referred to in Article 4; (c) the entry of fingerprint data into ECRIS-TCN, in particular the application of the minimum criteria as referred to in point (b)(ii) of Article 5(1); (d) the impact of ECRIS and of ECRIS-TCN on the protection of personal data. The assessment may be accompanied, if necessary, by legislative proposals. Subsequent overall evaluations may include an assessment of any or all of those aspects. 11. The Member States, Eurojust, Europol and the EPPO shall provide eu-LISA and the Commission with the information necessary to draft the reports referred to in paragraphs 3, 8 and 9 according to the quantitative indicators predefined by the Commission or eu-LISA or both. That information shall not jeopardise working methods or include information that reveals sources, staff members or investigations. 12. Where relevant, the supervisory authorities shall provide eu-LISA and the Commission with the information necessary to draft the reports referred to in paragraph 9 according to the quantitative indicators predefined by the Commission or eu-LISA or both. That information shall not jeopardise working methods or include information that reveals sources, staff members or investigations. 13. eu-LISA shall provide the Commission with the information necessary to produce the overall evaluations referred to in paragraph 9. Article 37 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 6(2) shall be conferred on the Commission for an indeterminate period of time from 11 June 2019. 3. The delegation of power referred to in Article 6(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 6(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 38 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 39 Advisory Group eu-LISA shall establish an Advisory Group in order to obtain expertise related to ECRIS-TCN and the ECRIS reference implementation, in particular in the context of preparation of its annual work programme and its annual activity report. During the design and development phase, Article 11(9) shall apply. Article 40 Amendments to Regulation (EU) 2018/1726 Regulation (EU) 2018/1726 is amended as follows: (1) In Article 1, paragraph 4 is replaced by the following: \u20184. The Agency shall be responsible for the preparation, development or operational management of the Entry/Exit System (EES), DubliNet, the European Travel Information and Authorisation System (ETIAS), ECRIS-TCN and the ECRIS reference implementation.\u2019; (2) The following Article is inserted: \u2018Article 8a Tasks related to ECRIS-TCN and the ECRIS reference implementation In relation to ECRIS-TCN and the ECRIS reference implementation, the Agency shall perform: (a) the tasks conferred on it by Regulation (EU) 2019/816 of the European Parliament and of the Council (*1); (b) tasks relating to training on the technical use of ECRIS-TCN and the ECRIS reference implementation. (*1) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System) and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).\u2019;\" (3) In Article 14, paragraph 1 is replaced by the following: \u20181. The Agency shall monitor developments in research relevant for the operational management of SIS II, VIS, Eurodac, the EES, ETIAS, DubliNet, ECRIS-TCN and other large-scale IT systems as referred to in Article 1(5).\u2019; (4) In Article 19, paragraph 1 is amended as follows: (a) point (ee) is replaced by the following: \u2018(ee) adopt the reports on the development of the EES pursuant to Article 72(2) of Regulation (EU) 2017/2226, the reports on the development of ETIAS pursuant to Article 92(2) of Regulation (EU) 2018/1240 and the reports on the development of ECRIS-TCN and of the ECRIS reference implementation pursuant to Article 36(3) of Regulation (EU) 2019/816;\u2019; (b) point (ff) is replaced by the following: \u2018(ff) adopt the reports on the technical functioning of SIS II pursuant to Article 50(4) of Regulation (EC) No 1987/2006 and Article 66(4) of Decision 2007/533/JHA respectively, of VIS pursuant to Article 50(3) of Regulation (EC) No 767/2008 and Article 17(3) of Decision 2008/633/JHA, of the EES pursuant to Article 72(4) of Regulation (EU) 2017/2226, of ETIAS pursuant to Article 92(4) of Regulation (EU) 2018/1240, and of ECRIS-TCN and of the ECRIS reference implementation pursuant to Article 36(8) of Regulation (EU) 2019/816;\u2019; (c) point (hh) is replaced by the following: \u2018(hh) adopt formal comments on the European Data Protection Supervisor's reports on the audits carried out pursuant to Article 45(2) of Regulation (EC) No 1987/2006, Article 42(2) of Regulation (EC) No 767/2008 and Article 31(2) of Regulation (EU) No 603/2013, Article 56(2) of Regulation (EU) 2017/2226, Article 67 of Regulation (EU) 2018/1240 and to Article 29(2) of Regulation (EU) 2019/816 and ensure appropriate follow-up of those audits;\u2019; (d) the following point is inserted: \u2018(lla) submit to the Commission statistics related to ECRIS-TCN and to the ECRIS reference implementation pursuant to the second subparagraph of Article 32(3) of Regulation (EU) 2019/816;\u2019; (e) point (mm) is replaced by the following: \u2018(mm) ensure annual publication of the list of competent authorities authorised to search directly the data contained in SIS II pursuant to Article 31(8) of Regulation (EC) No 1987/2006 and Article 46(8) of Decision 2007/533/JHA, together with the list of Offices of the national systems of SIS II (N.SIS II Offices) and SIRENE Bureaux pursuant to Article 7(3) of Regulation (EC) No 1987/2006 and Article 7(3) of Decision 2007/533/JHA respectively as well as the list of competent authorities pursuant to Article 65(2) of Regulation (EU) 2017/2226, the list of competent authorities pursuant to Article 87(2) of Regulation (EU) 2018/1240 and the list of central authorities pursuant to Article 34(2) of Regulation (EU) 2019/816;\u2019; (5) In Article 22(4), the following subparagraph is inserted after the third subparagraph: \u2018Eurojust, Europol and the EPPO may attend the meetings of the Management Board as observers when a question concerning ECRIS-TCN in relation to the application of Regulation (EU) 2019/816 is on the agenda.\u2019; (6) In Article 24(3), point (p) is replaced by the following: \u2018(p) establishing, without prejudice to Article 17 of the Staff Regulations of Officials, confidentiality requirements in order to comply with Article 17 of Regulation (EC) No 1987/2006, Article 17 of Decision 2007/533/JHA, Article 26(9) of Regulation (EC) No 767/2008, Article 4(4) of Regulation (EU) No 603/2013, Article 37(4) of Regulation (EU) 2017/2226, Article 74(2) of Regulation (EU) No 2018/1240 and Article 11(16) of Regulation (EU) 2019/816;\u2019; (7) In Article 27(1), the following point is inserted: \u2018(da) ECRIS-TCN Advisory Group;\u2019. Article 41 Implementation and transitional provisions 1. Member States shall take the necessary measures to comply with this Regulation as soon as possible so as to ensure the proper functioning of ECRIS-TCN. 2. For convictions handed down prior to the date of start of entry of data in accordance with Article 35(1), the central authorities shall create the individual data records in the central system as follows: (a) alphanumeric data to be entered into the central system by the end of the period referred to in Article 35(2); (b) fingerprint data to be entered into the central system within two years after the start of operations in accordance with Article 35(4). Article 42 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 17 April 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) Position of the European Parliament of 12 March 2019 (not yet published in the Official Journal) and decision of the Council of 9 April 2019. (2) Council Framework Decision 2008/675/JHA of 24 July 2008 on taking account of convictions in the Member States of the European Union in the course of new criminal proceedings (OJ L 220, 15.8.2008, p. 32). (3) Council Framework Decision 2009/315/JHA of 26 February 2009 on the organisation and content of the exchange of information extracted from the criminal record between Member States (OJ L 93, 7.4.2009, p. 23). (4) Council Decision 2009/316/JHA of 6 April 2009 on the establishment of the European Criminal Records Information System (ECRIS) in application of Article 11 of Framework Decision 2009/315/JHA (OJ L 93, 7.4.2009, p. 33). (5) Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, p. 99). (6) Directive 2011/93/EU of the European Parliament and of the Council of 13 December 2011 on combating the sexual abuse and sexual exploitation of children and child pornography, and replacing Council Framework Decision 2004/68/JHA (OJ L 335, 17.12.2011, p. 1). (7) Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, p. 138). (8) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53). (9) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor's Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (10) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (11) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (12) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (13) OJ L 123, 12.5.2016, p. 1. (14) Regulation (EU) No 182/2011 of the European Parliament and the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (15) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (16) OJ C 55, 14.2.2018, p. 4. (17) OJ L 56, 4.3.1968, p. 1. ANNEX STANDARD INFORMATION REQUEST FORM AS REFERRED TO IN ARTICLE 17(1) OF REGULATION (EU) 2019/816 IN ORDER TO OBTAIN INFORMATION ON WHICH MEMBER STATE, IF ANY, HOLDS CRIMINAL RECORDS INFORMATION OF A THIRD-COUNTRY NATIONAL Text of image This form, which is available at www.eurojust.europa.eu in all 24 official languages of the institutions of the Union, should be addressed in one of those languages to ECRIS-TCN@eurojust.europa.eu Requesting state or international organisation: Name of state or international organisation: Authority submitting the request: Represented by (name of person): Title: Address: Telephone number: Email address: Criminal proceedings for which the information is sought: Domestic reference number: Competent authority: Type of crimes under investigation (please mention relevant article(s) of criminal code): Other relevant information (e.g. urgency of the request): Identity information of the person having the nationality of a third country in respect of whom information regarding the convicting Member State is sought: NB: please provide as much available information as possible. Surname (family name): First name(s) (given names): Date of birth: Place of birth (town and country): Nationality or nationalities: Gender: Previous name(s), if applicable: Parents\u2019 names: Identity number: Type and number of the person\u2019s identification document(s): Issuing authority of document(s): Pseudonyms or aliases: If fingerprint data are available, please provide these. In case of multiple persons, please indicate them separately A drop down panel would allow the insertion of additional subjects Place Date (Electronic) signature and stamp:", "summary": "European Criminal Records Information System \u2013 conviction information on third-country nationals (ECRIS-TCN) European Criminal Records Information System \u2013 conviction information on third-country nationals (ECRIS-TCN) SUMMARY OF: Regulation (EU) 2019/816 setting up a centralised system for the identification of Member States holding conviction information on non-EU nationals and stateless persons (ECRIS-TCN) WHAT IS THE AIM OF THIS REGULATION? It establishes: a system called the European Criminal Records Information System \u2014 Third Country Nationals (ECRIS-TCN) to identify the EU Member States which hold information on previous convictions of \u2018third-country\u2019 (i.e. non-EU) nationals;the conditions under which national authorities may access ECRIS-TCN in order to obtain information on previous convictions through the European Criminal Records Information System (ECRIS) (Framework Decision 2009/315/JHA \u2014 see summary), as well as the conditions under which the European Public Prosecutor\u2019s Office (EPPO), the European Union Agency for Criminal Justice Cooperation (Eurojust) and the European Union Agency for Law Enforcement Cooperation (Europol) may use the system;the terms under which ECRIS-TCN helps to facilitate and assist in the correct identification of people registered in ECRIS-TCN. The regulation has been amended 3 times: by Regulation (EU) 2019/818, which sets up a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration (see summary);by Regulation (EU) 2021/1133, which sets the conditions under which the visa information system, set up under Regulation (EC) No 767/2008 (see summary), consults data stored in ECRIS-TCN;by Regulation (EU) 2021/1151, which sets the conditions under which the European Travel Information and Authorisation System (ETIAS), set up under Regulation (EU) 2018/1240 (see summary), consults data stored in ECRIS-TCN. KEY POINTS The legislation applies to the processing of identity information of non-EU nationals with prior convictions* in one of the Member States, in order to determine which Member State handed down the sentence. It applies equally to EU citizens who also hold non-EU nationality. Information on the conviction itself can only be obtained from the convicting Member State. The technical architecture of ECRIS-TCN consists of: a central system which is hosted by the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA); a national central access point in each Member State; interface software enabling authorities to connect to the central system; a communication infrastructure between the central system and national central access points. National central authorities* create a data record in ECRIS-TCN as quickly as possible for each non-EU national they convict. This contains: family and first names, date and place of birth, nationality(ies), gender, previous names if applicable and the code of the convicting Member State; if available, parents\u2019 names, details of the individual\u2019s identity documents and pseudonyms or aliases; fingerprint data collected according to national law and satisfying certain technical specifications; facial images, if allowed under the national law of the convicting Member State. National central authorities shall use ECRIS-TCN to identify the Member State holding criminal record information on a non-EU national, in order to subsequently obtain information on an individual\u2019s previous convictions via ECRIS, when this is required for the purposes of criminal proceedings against that individual or for: checking a person\u2019s own criminal record at their request; obtaining a security clearance; obtaining a licence or permit; employment vetting; voluntary activities involving direct and regular contact with children or vulnerable people; visa, citizenship, migration and asylum procedures; checks linked to public contracts and public examinations. The EPPO, Eurojust and Europol: may access ECRIS-TCN directly to identify the Member States holding criminal records information on a non-EU national; may not enter, correct or erase any data in ECRIS-TCN; may request criminal records information from the Member State concerned when a hit* occurs via their own channels; are responsible for their technical connections to ECRIS-TCN; shall provide staff with appropriate training, especially on data security, data protection and fundamental rights. Non-EU countries and international organisations may ask Eurojust for information on which Member States may hold criminal records of a non-EU national concerned, only for the purposes of criminal proceedings. If there is a hit, and the Member State concerned consents, Eurojust shall inform the non-EU country or international organisation on which Member State is concerned, so that they may ask that Member State for the relevant extracts from the criminal records. Data: are stored in the central system for as long as they are kept in the national criminal records; are erased by national authorities when the national retention period expires; may be modified or erased by the Member States which entered them in the central system; may only be processed to identify the Member States holding criminal record information of non-EU nationals. eu-LISA is responsible for: developing ECRIS-TCN, its operational management and maintaining the ECRIS reference implementation*; supervising the communication infrastructure, including its security; maintaining procedures for carrying out quality checks on data stored in ECRIS-TCN and monitoring its functioning and technical maintenance; submitting regular reports to the European Parliament, the Council of the European Union and the European Commission; providing the necessary technical training; applying appropriate rules on professional secrecy and confidentiality; taking the necessary measures to ensure ECRIS-TCN\u2019s security; logging all data processing operations in ECRIS-TCN; giving the Commission monthly statistics on the recording, storage and exchange of information extracted from criminal records through ECRIS-TCN and the ECRIS reference implementation. Member States are responsible for: a secure connection between their national criminal records, fingerprint databases and national central access point; management of duly authorised staff of the central authorities and their training; lawful processing of data recorded in ECRIS-TCN and, in particular, that only authorised staff have access to the datathe data are collected and entered into ECRIS-TCN lawfully, respecting non-EU nationals\u2019 human dignity and fundamental rightsthe information is accurate and up-to-date when entered into ECRIS-TCN; each central authority taking the necessary measures to comply with the legislation; national supervisory authorities monitoring the legality of the processing of personal data. An individual or a Member State suffering damage from behaviour incompatible with the regulation may receive compensation from: the Member State responsible for the damage; eu-LISA if the agency has not complied with its obligations. Non-EU nationals may contact a Member State\u2019s central authority to request access to their personal data, its correction, erasure or restriction on its use. Penalties or disciplinary measures apply with respect to any misuse of data entered in ECRIS-TCN. The European Data Protection Supervisor monitors eu-LISA\u2019s personal data processing activities and produces an audit at least every 3 years for the European Parliament, the Council and the Commission. Amending legislation setting conditions of access to ECRIS-TCN data: Amending Regulation (EU) 2021/1133 sets the conditions under which data contained in the ECRIS-TCN may be consulted and used for the purposes of the visa information system. Amending Regulation (EU) 2021/1151 sets out the conditions under which data contained in the ECRIS-TCN may be used by the central unit of ETIAS in order to allow for a thorough assessment of the security risks posed by applicants before their arrival at external border crossing points. FROM WHEN DOES THE REGULATION APPLY? It has applied since 11 June 2019. Member States have to take the necessary measures to comply as soon as possible so as to ensure the proper functioning of ECRIS-TCN. The Commission must be satisfied that certain conditions are met before determining the date from which Member States may start entering data into the ECRIS-TCN. After the final technical tests conducted by eu-LISA, the Commission will decide when the system is to start operation. BACKGROUND For more information, see: European Criminal Records Information System (ECRIS) (European Commission). KEY TERMS Conviction: any final decision by a criminal court against an individual and entered in the criminal records. Central authority: a national criminal records authority designated in accordance with Article 3(1) of Framework Decision 2009/315/JHA. Hit: a match between the identity information recorded in the central system and that used for a search. ECRIS reference implementation: software developed by the Commission and made available to Member States for the exchange of criminal records data through ECRIS. MAIN DOCUMENT Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, pp. 1-26) Successive amendments to Regulation (EU) 2019/816 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2021/1133 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EU) No 603/2013, (EU) 2016/794, (EU) 2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards the establishment of the conditions for accessing other EU information systems for the purposes of the Visa Information System (OJ L 248, 13.7.2021, pp. 1-10) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ L 135, 22.5.2019, pp. 85-135) See consolidated version. Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, pp. 138-183) Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, pp. 99-137) See consolidated version. Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, pp. 39-98) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, pp. 1-71) See consolidated version. Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, pp. 1-71) See consolidated version. Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, pp. 53-114) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) See consolidated version. Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, pp. 89-131) See consolidated version. Council Framework Decision 2009/315/JHA of 26 February 2009 on the organisation and content of the exchange of information extracted from the criminal record between Member States (OJ L 93, 7.4.2009, pp. 23-32) See consolidated version. Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning the Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (VIS Regulation) (OJ L 218, 13.8.2008, pp. 60-81) See consolidated version. last update 08.09.2021"}
{"article": "22.5.2019 EN Official Journal of the European Union L 135/27 REGULATION (EU) 2019/817 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16(2), Article 74 and Article 77(2)(a), (b), (d) and (e) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) In its Communication of 6 April 2016 entitled Stronger and Smarter Information Systems for Borders and Security, the Commission underlined the need to improve the Union's data management architecture for border management and security. The Communication initiated a process towards achieving interoperability between EU information systems for security, border and migration management, with the aim to address the structural shortcomings related to those systems that impede the work of national authorities and to ensure that border guards, customs authorities, police officers and judicial authorities have the necessary information at their disposal. (2) In its Roadmap to enhance information exchange and information management including interoperability solutions in the Justice and Home Affairs area of 6 June 2016, the Council identified various legal, technical and operational challenges in the interoperability of EU information systems and called for the pursuit of solutions. (3) In its Resolution of 6 July 2016 on the strategic priorities for the Commission Work Programme 2017 (3), the European Parliament called for proposals to improve and develop existing EU information systems, address information gaps and move towards their interoperability, as well as proposals for compulsory information sharing at EU level, accompanied by the necessary data protection safeguards. (4) In its conclusions of 15 December 2016 the European Council called for work to continue on delivering interoperability of EU information systems and databases. (5) In its final report of 11 May 2017, the high-level expert group on information systems and interoperability concluded that it was necessary and technically feasible to work towards practical solutions for interoperability and that interoperability could, in principle, both deliver operational gains and be established in compliance with data protection requirements. (6) In its Communication of 16 May 2017 entitled Seventh progress report towards an effective and genuine Security Union, the Commission set out, in line with its Communication of 6 April 2016 and the findings and recommendations of the high-level expert group on information systems and interoperability, a new approach to the management of data for borders, security and migration whereby all EU information systems for security, border and migration management were to be interoperable, in a manner fully respecting fundamental rights. (7) In its Conclusions of 9 June 2017 on the way forward to improve information exchange and ensure the interoperability of EU information systems, the Council invited the Commission to pursue the solutions for interoperability proposed by the high-level expert group. (8) In its conclusions of 23 June 2017 the European Council underlined the need to improve interoperability between databases and invited the Commission to prepare draft legislation on the basis of the proposals made by the high-level expert group on information systems and interoperability as soon as possible. (9) With a view to improving the effectiveness and efficiency of checks at the external borders, to contributing to prevention and combating illegal immigration and to contributing to a high level of security within the area of freedom, security and justice of the Union, including the maintenance of public security and public policy and safeguarding security in the territories of the Member States, to improving the implementation of the common visa policy, to assisting in the examination of applications for international protection, to contributing to the prevention, detection and investigation of terrorist offences and other serious criminal offences, to facilitating the identificaton of unknown persons who are unable to identify themselves or unidentified human remains in the case of a natural disaster, accident or terrorist attack, in order to maintain public trust in the Union migration and asylum system, Union security measures and Union capabilities to manage the external border, interoperability between EU information systems, namely the Entry/Exit System (EES), the Visa Information System (VIS), the European Travel Information and Authorisation System (ETIAS), Eurodac, the Schengen Information System (SIS), and the European Criminal Records Information System for Third-Country Nationals (ECRIS-TCN) should be established in order for these EU information systems and their data to supplement each other while respecting the fundamental rights of individuals, in particular the right to protection of personal data. To achieve this, a European search portal (ESP), a shared biometric matching service (shared BMS), a common identity repository (CIR) and a multiple-identity detector (MID) should be established as interoperability components. (10) Interoperability between the EU information systems should allow those systems to supplement each other in order to facilitate the correct identification of persons, including unknown persons who are unable to identify themselves or unidentified human remains, contribute to combating identity fraud, improve and harmonise the data quality requirements of the respective EU information systems, facilitate the technical and operational implementation by Member States of EU information systems, strengthen the data security and data protection safeguards that govern the respective EU information systems, streamline access for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences to the EES, VIS, ETIAS and Eurodac, and support the purposes of the EES, VIS, ETIAS, Eurodac, SIS and ECRIS-TCN. (11) The interoperability components should cover the EES, VIS, ETIAS, Eurodac, SIS, and ECRIS-TCN. They should also cover Europol data, but only to the extent of enabling Europol data to be queried simultaneously with those EU information systems. (12) The interoperability components should process the personal data of persons whose personal data are processed in the underlying EU information systems and by Europol. (13) The ESP should be established to facilitate technically the fast, seamless, efficient, systematic and controlled access by Member State authorities and Union agencies to the EU information systems, to Europol data and to the International Criminal Police Organization (Interpol) databases, insofar as this is needed to perform their tasks in accordance with their access rights. The ESP should also be established to support the objectives of the EES, VIS, ETIAS, Eurodac, SIS, ECRIS-TCN and Europol data. By enabling all relevant EU information systems, Europol data and the Interpol databases to be queried in parallel, the ESP should act as a single window or \u2018message broker\u2019 to search the various central systems and retrieve the necessary information seamlessly and in full respect of the access control and data protection requirements of the underlying systems. (14) The design of the ESP should ensure that, when querying the Interpol databases, the data used by an ESP user to launch a query is not shared with the owners of Interpol data. The design of the ESP should also ensure that the Interpol databases are only queried in accordance with applicable Union and national law. (15) The Interpol database of Stolen and Lost Travel Documents (SLTD database) enables authorised entities responsible for preventing, detecting or investigating terrorist offences or other serious criminal offences in Member States, including immigration and border control authorities, to establish the validity of a travel document. ETIAS queries the SLTD database and the Interpol Travel Documents Associated with Notices database (TDAWN database) in the context of assessing whether a person applying for a travel authorisation is likely for instance to migrate irregularly or could pose a threat to security. The ESP should enable queries against the SLTD and TDAWN databases using an individual's identity data or travel document data. Where personal data are transferred from the Union to Interpol through the ESP, the provisions on international transfers in Chapter V of Regulation (EU) 2016/679 of the European Parliament and of the Council (4), or the national provisions transposing Chapter V of Directive (EU) 2016/680 of the European Parliament and of the Council (5) should apply. This should be without prejudice to the specific rules laid down in Council Common Position 2005/69/JHA (6) and Council Decision 2007/533/JHA (7). (16) The ESP should be developed and configured in such a way that it only allows such queries to be performed using data related to persons or travel documents held in an EU information system, in Europol data or in the Interpol databases. (17) To ensure the systematic use of the relevant EU information systems, the ESP should be used to query the CIR, the EES, VIS, ETIAS, Eurodac and ECRIS-TCN. However, a national connection to the different EU information systems should remain in order to provide a technical fall back. The ESP should also be used by Union agencies to query Central SIS in accordance with their access rights and in order to perform their tasks. The ESP should be an additional means to query Central SIS, Europol data and the Interpol databases, complementing the existing dedicated interfaces. (18) Biometric data, such as fingerprints and facial images, are unique and therefore much more reliable than alphanumeric data for the purposes of identifying a person. The shared BMS should be a technical tool to reinforce and facilitate the work of the relevant EU information systems and the other interoperability components. The main purpose of the shared BMS should be to facilitate the identification of an individual who is registered in several databases, by using a single technological component to match that individual's biometric data across different systems, instead of several components. The shared BMS should contribute to security, as well as financial, maintenance and operational benefits. All automated fingerprint identification systems, including those currently used for Eurodac, VIS and SIS, use biometric templates comprised of data derived from a feature extraction of actual biometric samples. The shared BMS should regroup and store all these biometric templates \u2013 logically separated according to the information system from which the data originated \u2013 in one single location, thereby facilitating cross-system comparisons using biometric templates and enabling economies of scale in developing and maintaining the EU central systems. (19) The biometric templates stored in the shared BMS should be comprised of data derived from a feature extraction of actual biometric samples and obtained in such a way that reversing the extraction process is not possible. Biometric templates should be obtained from biometric data but it should not be possible to obtain that same biometric data from the biometric templates. As palm print data and DNA profiles are only stored in SIS and cannot be used to perform cross-checks with data present in other information systems, following the principles of necessity and proportionality, the shared BMS should not store DNA profiles or biometric templates obtained from palm print data. (20) Biometric data constitute sensitive personal data. This Regulation should lay down the basis and the safeguards for processing such data for the purpose of uniquely identifying the persons concerned. (21) The EES, VIS, ETIAS, Eurodac and ECRIS-TCN require accurate identification of the persons whose personal data are stored in them. The CIR should therefore facilitate the correct identification of persons registered in those systems. (22) Personal data stored in those EU information systems may relate to the same persons but under different or incomplete identities. Member States dispose of efficient ways to identify their citizens or registered permanent residents in their territory. The interoperability between EU information systems should contribute to the correct identification of persons present in those systems. The CIR should store the personal data that are necessary to enable the more accurate identification of the individuals whose data are stored in those systems, including their identity data, travel document data and biometric data, regardless of the system in which the data were originally collected. Only the personal data strictly necessary to perform an accurate identity check should be stored in the CIR. The personal data recorded in the CIR should be kept for no longer than is strictly necessary for the purposes of the underlying systems and should be automatically deleted when the data are deleted from the underlying systems in accordance with their logical separation. (23) A new processing operation consisting of the storage of such data in the CIR instead of the storage in each of the separate systems is necessary to increase the accuracy of identification through the automated comparison and matching of the data. The fact that identity data, travel document data and biometric data are stored in the CIR should not hinder in any way the processing of data for the purposes of the EES, VIS, ETIAS, Eurodac or ECRIS-TCN, as the CIR should be a new shared component of those underlying systems. (24) It is therefore necessary to create an individual file in the CIR for each person registered in the EES, VIS, ETIAS, Eurodac or ECRIS-TCN, to achieve the purpose of correct identification of persons within the Schengen area and to support the MID for the dual purpose of facilitating identity checks for bona fide travellers and combating identity fraud. The individual file should store all the identity information linked to a person in a single place and make it accessible to duly authorised end-users. (25) The CIR should thus facilitate and streamline access by authorities responsible for preventing, detecting or investigating terrorist offences or other serious criminal offences to the EU information systems that are not established exclusively for purposes of prevention, detection or investigation of serious crime. (26) The CIR should provide for a shared container for identity data, travel document data and biometric data of persons registered in the EES, VIS, ETIAS, Eurodac and the ECRIS-TCN. It should be part of the technical architecture of these systems and serve as the shared component between them for storing and querying the identity data, travel document data and biometric data they process. (27) All records in the CIR should be logically separated by automatically tagging each record with the name of the underlying system owning that record. The access controls of the CIR should use these tags to determine whether to allow access to the record. (28) Where a Member State police authority is unable to identify a person due to the lack of a travel document or another credible document proving that person's identity, or where there are doubts about the identity data provided by that person or as to the authenticity of the travel document or the identity of its holder, or where the person is unable or refuses to cooperate, that police authority should be able to query the CIR in order to identify the person. For those purposes, police authorities should capture fingerprints using live-scan fingerprinting techniques, provided that the procedure was initiated in the presence of that person. Such queries of the CIR should not be permitted for the purposes of identifying minors under the age of 12 years old, unless in the best interests of the child. (29) Where the biometric data of a person cannot be used or if a query with that data fails, the query should be carried out with identity data of the person in combination with travel document data. Where the query indicates that data on that person are stored in the CIR, Member State authorities should have access to the CIR to consult the identity data and travel document data of that person, without the CIR providing any indication as to which EU information system the data belong. (30) Member States should adopt national legislative measures designating the authorities competent to perform identity checks using the CIR and laying down the procedures, conditions and criteria for such checks, which should follow the principle of proportionality. In particular, the power to collect biometric data during an identity check of a person present before a staff member of those authorities should be provided for by national law. (31) This Regulation should also introduce a new possibility for streamlined access to data beyond the identity data or travel document data present in the EES, VIS, ETIAS or Eurodac by Member State designated authorities responsible for preventing, detecting or investigating terrorist offences or other serious criminal offences and Europol. Such data may be necessary for the prevention, detection or investigation of terrorist offences or other serious criminal offences in a specific case where there are reasonable grounds to believe that consulting them will contribute to the prevention, detection or investigation of the terrorist offences or other serious criminal offences, in particular where there is a suspicion that the suspect, perpetrator or victim of a terrorist offence or other serious criminal offence is a person whose data are stored in the EES, VIS, ETIAS or Eurodac. (32) Full access to data contained in the EES, VIS, ETIAS or Eurodac that is necessary for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences, beyond access to identity data or travel document data held in the CIR, should continue to be governed by the applicable legal instruments. The designated authorities responsible for preventing, detecting or investigating terrorist offences or other serious criminal offences and Europol do not know in advance which of the EU information systems contains data of the persons they need to inquire upon. This results in delays and inefficiencies. The end-user authorised by the designated authority should therefore be allowed to see in which of those EU information systems the data corresponding to the result of a query are recorded. The system concerned would thus be flagged following the automated verification of the presence of a match in the system (a so-called match-flag functionality). (33) In this context, a reply from the CIR should not be interpreted or used as a ground or reason to draw conclusions on or undertake measures in respect of a person, but should be used only for the purpose of submitting an access request to the underlying EU information systems, subject to the conditions and procedures laid down in the respective legal instruments governing such access. Any such access request should be subject to Chapter VII of this Regulation and as applicable, Regulation (EU) 2016/679, Directive (EU) 2016/680 or Regulation (EU) 2018/1725 of the European Parliament and of the Council (8). (34) As a general rule, where a match-flag indicates that the data are recorded in the EES, VIS, ETIAS or Eurodac, the designated authorities or Europol should request full access to at least one of the EU information systems concerned. Where exceptionally such full access is not requested, for example because designated authorities or Europol have already obtained the data by other means, or obtaining the data is no longer permitted under national law, the justification for not requesting access should be recorded. (35) The logs of the queries of the CIR should indicate the purpose of the queries. Where such a query was performed using the two-step data consultation approach, the logs should include a reference to the national file of the investigation or case, thereby indicating that the query was launched for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences. (36) The query of the CIR by the designated authorities and Europol in order to obtain a match-flag type of response indicating that the data are recorded in the EES, VIS, ETIAS or Eurodac requires automated processing of personal data. A match-flag should not reveal personal data of the concerned individual other than an indication that some of his or her data are stored in one of the systems. No adverse decision for the individual concerned should be made by the authorised end-user solely on the basis of the simple occurrence of a match-flag. Access by the end-user to a match-flag will therefore constitute a very limited interference with the right to protection of personal data of the individual concerned, while allowing the designated authorities and Europol to request access to personal data more effectively. (37) The MID should be established to support the functioning of the CIR and to support the objectives of the EES, VIS, ETIAS, Eurodac, SIS and ECRIS-TCN. In order to be effective in fulfilling their respective objectives, all of these EU information systems require the accurate identification of the persons whose personal data are stored in them. (38) To better attain the objectives of EU information systems, the authorities using those systems should be able to conduct sufficiently reliable verifications of the identities of the persons whose data are stored in different systems. The set of identity data or travel document data stored in a given individual system may be incorrect, incomplete or fraudulent, and there is currently no way of detecting incorrect, incomplete or fraudulent identity data or travel document data by way of comparison with data stored in another system. To remedy this situation, it is necessary to have a technical instrument at Union level allowing accurate identification of persons for these purposes. (39) The MID should create and store links between data in the different EU information systems in order to detect multiple identities, with the dual purpose of facilitating identity checks for bona fide travellers and combating identity fraud. The MID should only contain links between data on individuals present in more than one EU information system. The linked data should be strictly limited to the data necessary to verify that a person is recorded in a justified or unjustified manner under different identities in different systems, or to clarify that two persons having similar identity data may not be the same person. Data processing through the ESP and the shared BMS in order to link individual files across different systems should be kept to an absolute minimum and therefore limited to multiple-identity detection, to be conducted at the time new data are added in one of the systems which has data stored in the CIR or added in SIS. The MID should include safeguards against potential discrimination and unfavourable decisions for persons with multiple lawful identities. (40) This Regulation provides for new data processing operations aimed at identifying the persons concerned correctly. This constitutes an interference with their fundamental rights as protected by Articles 7 and 8 of the Charter of Fundamental Rights of the European Union. Since the effective implementation of the EU information systems is dependent upon correct identification of the individuals concerned, such interference is justified by the same objectives for which each of those systems have been established, the effective management of the Union's borders, the internal security of the Union and the effective implementation of the Union's asylum and visa policies. (41) The ESP and the shared BMS should compare data on persons in the CIR and SIS when new records are created or uploaded by a national authority or a Union agency. Such comparison should be automated. The CIR and SIS should use the shared BMS to detect possible links on the basis of biometric data. The CIR and SIS should use the ESP to detect possible links on the basis of alphanumeric data. The CIR and SIS should be able to identify the same or similar data on a person stored across several systems. Where such is the case, a link indicating that it is the same person should be established. The CIR and SIS should be configured in such a way that small transliteration or spelling mistakes are detected in such a way as not to create any unjustified hindrance to the person concerned. (42) The national authority or Union agency that recorded the data in the respective EU information system should confirm or change the links. This national authority or Union agency should have access to the data stored in the CIR or SIS and in the MID for the purpose of a manual verification of different identities. (43) A manual verification of different identities should be ensured by the authority creating or updating the data that triggered a match resulting in a link with data stored in another EU information system. The authority responsible for the manual verification of different identities should assess whether there are multiple identities referring to the same person in a justified or unjustified manner. Such an assessment should be performed where possible in the presence of the person concerned and where necessary by requesting additional clarifications or information. The assessment should be performed without delay, in line with legal requirements for the accuracy of information under Union and national law. At the borders especially, the movement of the persons involved will be restricted for the duration of the verification, which should therefore not last indefinitely. The existence of a yellow link in the MID should not constitute in itself a ground for refusal of entry and any decision on authorising or refusing entry should be taken exclusively on the basis of the applicable provisions of Regulation (EU) 2016/399 of the European Parliament and of the Council (9). (44) For links obtained through SIS related to alerts in respect of persons wanted for arrest for surrender or extradition purposes, on missing or vulnerable persons, on persons sought to assist with a judicial procedure or on persons for discreet checks, inquiry checks or specific checks, the authority responsible for the manual verification of different identities should be the SIRENE Bureau of the Member State that created the alert. These categories of SIS alerts are sensitive and should not necessarily be shared with the authorities creating or updating data that are linked to them in one of the other EU information systems. The creation of a link with SIS data should be without prejudice to the actions to be taken in accordance with Regulations (EU) 2018/1860 (10), (EU) 2018/1861 (11) and (EU) 2018/1862 (12) of the European Parliament and of the Council. (45) The creation of such links requires transparency towards the individuals affected. In order to facilitate the implementation of the necessary safeguards in accordance with applicable Union data protection rules, individuals who are subject to a red link or a white link following manual verification of different identities should be informed in writing without prejudice to limitations to protect security and public order, prevent crime and guarantee that national investigations are not jeopardised. Those individuals should receive a single identification number allowing them to identify the authority to which they should address themselves to exercise their rights. (46) Where a yellow link is created, the authority responsible for the manual verification of different identities should have access to the MID. Where a red link exists, Member State authorities and Union agencies having access to at least one EU information system included in the CIR or to SIS should have access to the MID. A red link should indicate that a person is using different identities in an unjustified manner or that a person is using somebody else's identity. (47) Where a white or green link exists between data from two EU information systems, Member State authorities and Union agencies should have access to the MID where the authority or agency concerned has access to both information systems. Such access should be granted for the sole purpose of allowing that authority or agency to detect potential cases where data have been linked incorrectly or processed in the MID, CIR and SIS in breach of this Regulation and of taking action to correct the situation and update or delete the link. (48) The European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) should establish automated data quality control mechanisms and common data quality indicators. eu-LISA should be responsible for developing a central monitoring capacity for data quality and for producing regular data analysis reports to improve the control of the implementation by Member States of EU information systems. The common data quality indicators should include minimum quality standards for storing data in the EU information systems or interoperability components. The goal of such data quality standards should be for the EU information systems and interoperability components to identify automatically apparently incorrect or inconsistent data submissions, so that the originating Member State is able to verify the data and carry out any necessary remedial action. (49) The Commission should evaluate eu-LISA's quality reports and should issue recommendations to Member States where appropriate. Member States should be responsible for preparing an action plan describing actions to remedy any deficiencies in data quality and should report on its progress regularly. (50) The universal message format (UMF) should serve as a standard for structured, cross-border information exchange between information systems, authorities or organisations in the field of Justice and Home Affairs. The UMF should define a common vocabulary and logical structures for commonly exchanged information with the objective to facilitate interoperability by enabling the creation and reading of the contents of exchanges in a consistent and semantically equivalent manner. (51) The implementation of the UMF standard may be considered in VIS, SIS and in any other existing or new cross-border information exchange models and information systems in the area of Justice and Home Affairs developed by Member States. (52) A central repository for reporting and statistics (CRRS) should be established to generate cross-system statistical data and analytical reporting for policy, operational and data quality purposes in accordance with the applicable legal instruments. eu-LISA should establish, implement and host the CRRS in its technical sites. It should contain anonymised statistical data from the EU information systems, the CIR, the MID and the shared BMS. The data contained in the CRRS should not enable the identification of individuals. eu-LISA should render the data anonymous in an automated manner and should record such anonymised data in the CRRS. The process for rendering the data anonymous should be automated and no direct access by eu-LISA staff should be granted to any personal data stored in the EU information systems or in the interoperability components. (53) Regulation (EU) 2016/679 applies to the processing of personal data for the purpose of interoperability under this Regulation by national authorities unless such processing is carried out by the designated authorities or central access points of the Member States for the purposes of the prevention, detection or investigation of terrorist offences or of other serious criminal offences. (54) Where the processing of personal data by the Member States for the purpose of interoperability under this Regulation is carried out by the competent authorities for the purposes of the prevention, detection or investigation of terrorist offences or of other serious criminal offences, Directive (EU) 2016/680 applies. (55) Regulation (EU) 2016/679, Regulation (EU) 2018/1725 or, where relevant, Directive (EU) 2016/680 apply to any transfer of personal data to third countries or international organisations carried out under this Regulation. Without prejudice to the grounds for transfer pursuant to Chapter V of Regulation (EU) 2016/679 or, where relevant, Directive (EU) 2016/680, any judgment of a court or tribunal and any decision of an administrative authority of a third country requiring a controller or processor to transfer or disclose personal data should only be recognised or enforceable in any manner if based on an international agreement in force between the requesting third country and the Union or a Member State. (56) The specific provisions on data protection of Regulations (EU) 2017/2226 (13), (EC) No 767/2008 (14), (EU) 2018/1240 (15) of the European Parliament and of the Council and Regulation (EU) 2018/1861 apply to the processing of personal data in the systems governed by those Regulations. (57) Regulation (EU) 2018/1725 applies to the processing of personal data by eu-LISA and other institutions and bodies of the Union when carrying out their responsibilities under this Regulation, without prejudice to Regulation (EU) 2016/794 of the European Parliament and of the Council (16), which applies to the processing of personal data by Europol. (58) The supervisory authorities referred to in Regulation (EU) 2016/679 or Directive (EU) 2016/680 should monitor the lawfulness of the processing of personal data by the Member States. The European Data Protection Supervisor should monitor the activities of the Union institutions and bodies in relation to the processing of personal data. The European Data Protection Supervisor and the supervisory authorities should cooperate with each other in the monitoring of the processing of personal data by interoperability components. For the European Data Protection Supervisor to fulfil the tasks entrusted to it under this Regulation, sufficient resources, including both human and financial resources, are required. (59) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (17) and delivered an opinion on 16 April 2018 (18). (60) The Article 29 Data Protection Working Party provided an opinion on 11 April 2018. (61) Both the Member States and eu-LISA should maintain security plans in order to facilitate the implementation of security obligations and should cooperate with each other in order to address security issues. eu-LISA should also make sure there is a continuous use of the latest technological developments to ensure data integrity in the context of the development, design and management of the interoperability components. eu-LISA's obligations in this respect should include adopting the measures necessary to prevent access by unauthorised persons, such as staff of external service providers, to personal data processed through the interoperability components. When awarding contracts for the provision of services, the Member States and eu-LISA should consider all measures necessary to secure compliance with laws or regulations relating to the protection of personal data and to the privacy of individuals or to safeguard essential security interests, pursuant to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (19) and applicable international conventions. eu-LISA should apply the principles of privacy by design and by default during the development of the interoperability components. (62) The implementation of the interoperability components provided for in this Regulation will have an impact on the way checks are carried out at border crossing points. The impact will result from the combined application of the existing rules of Regulation (EU) 2016/399 and the rules on interoperability provided for in this Regulation. (63) As a consequence of this combined application of the rules, the ESP should constitute the main access point for the compulsory systematic consultation of databases in respect of persons at border crossing points provided for by Regulation (EU) 2016/399. In addition, the identity data or travel document data that have led to the classification of a link in the MID as a red link should be taken into account by border guards for the purposes of assessing whether or not the person fulfils the conditions of entry defined in Regulation (EU) 2016/399. However, the presence of a red link should not in itself constitute a ground for refusal of entry and the existing grounds for refusal of entry listed in Regulation (EU) 2016/399 should therefore not be amended. (64) It would be appropriate to update the Practical Handbook for Border Guards to make these clarifications explicit. (65) Should a query of the MID through the ESP result in a yellow link or detect a red link, the border guard should consult the CIR or SIS or both in order to assess the information on the person being checked, to manually verify his or her identity data and to adapt the colour of the link if required. (66) To support the purposes of statistics and reporting, it is necessary to grant access to authorised staff of the competent authorities, Union institutions and agencies referred to in this Regulation to consult certain data related to certain interoperability components without enabling the identification of individuals. (67) In order to allow Member State authorities and Union agencies to adapt to the new requirements on the use of the ESP, it is necessary to provide for a transitional period. Similarly, in order to allow for a coherent and optimal functioning of the MID, transitional measures should be established for the start of its operations. (68) Since the objective of this Regulation, namely, the establishment of a framework for interoperability between EU information systems, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (69) The remaining amount in the budget earmarked for smart borders in Regulation (EU) No 515/2014 of the European Parliament and of the Council (20) should be reallocated to this Regulation pursuant to Article 5(5)(b) of Regulation (EU) No 515/2014, to cover the costs of the development of the interoperability components. (70) In order to supplement certain detailed technical aspects of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of: \u2014 extending the transitional period for the use of the ESP; \u2014 extending the transitional period for multiple-identity detection carried out by the ETIAS Central Unit; \u2014 the procedures for determining the cases where identity data can be considered as the same or similar; \u2014 the rules on the operation of the CRRS, including specific safeguards for processing of personal data and the security rules applicable to the repository; and \u2014 detailed rules on the operation of the web portal. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (21). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member State' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (71) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to determine the dates from which the ESP, the shared BMS, the CIR, the MID and the CRRS are to start operations. (72) Implementing powers should also be conferred on the Commission relating to the adoption of detailed rules on: the technical details of the ESP user profiles; the specifications of the technical solution allowing the EU information systems, Europol data and Interpol databases to be queried through the ESP and the format of the ESP's replies; the technical rules for creating links in the MID between data from different EU information systems; the content and presentation of the form to be used to inform the data subject when a red link is created; the performance requirements and performance monitoring of the shared BMS; automated data quality control mechanisms, procedures and indicators; the development of the UMF standard; the cooperation procedure to be used in the case of a security incident; and the specifications of the technical solution for Member States to manage users access requests. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (22). (73) As the interoperability components will involve the processing of significant amounts of sensitive personal data, it is important that persons whose data are processed through those components can effectively exercise their rights as data subjects as required under Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725. The data subjects should be provided with a web portal that facilitates their exercise of their rights of access to, rectification, erasure and restriction of processing of their personal data. eu-LISA should establish and manage such a web portal. (74) One of the core principles of data protection is data minimisation: under Article 5(1)(c) of Regulation (EU) 2016/679, the processing of personal data must be adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed. For this reason, the interoperability components should not provide for the storage of any new personal data, with the exception of the links which will be stored in the MID and which are the minimum necessary for the purposes of this Regulation. (75) This Regulation should contain clear provisions on liability and the right to compensation for unlawful processing of personal data and for any other act incompatible with it. Such provisions should be without prejudice to the right to compensation from, and liability of the controller or processor under Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725. eu-LISA should be responsible for any damage it causes in its capacity as a data processor where it has not complied with the obligations specifically imposed on it by this Regulation, or where it has acted outside or contrary to lawful instructions of the Member State which is the data controller. (76) This Regulation is without prejudice to the application of Directive 2004/38/EC of the European Parliament and of the Council (23). (77) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (78) This Regulation constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (24); the United Kingdom is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (79) This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (25); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (80) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters' association with the implementation, application and development of the Schengen acquis (26) which fall within the area referred to in Article 1, points A, B, C and G of Council Decision 1999/437/EC (27). (81) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (28) which fall within the area referred to in Article 1, points A, B, C and G of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (29). (82) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (30) which fall within the area referred to in Article 1, points A, B, C and G of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (31). (83) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and should be applied in accordance with those rights and principles. (84) In order to have this Regulation fit into the existing legal framework, Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861, and Council Decisions 2004/512/EC (32) and 2008/633/JHA (33) should be amended accordingly, HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject matter 1. This Regulation, together with Regulation (EU) 2019/818 of the European Parliament and of the Council (34), establishes a framework to ensure interoperability between the Entry/Exit System (EES), the Visa Information System (VIS), the European Travel Information and Authorisation System (ETIAS), Eurodac, the Schengen Information System (SIS), and the European Criminal Records Information System for third-country nationals (ECRIS-TCN). 2. The framework shall include the following interoperability components: (a) a European search portal (ESP); (b) a shared biometric matching service (shared BMS); (c) a common identity repository (CIR); (d) a multiple-identity detector (MID). 3. This Regulation also lays down provisions on data quality requirements, on a universal message format (UMF), on a central repository for reporting and statistics (CRRS) and on the responsibilities of the Member States and of the European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice (eu-LISA), with respect to the design, development and operation of the interoperability components. 4. This Regulation also adapts the procedures and conditions for the designated authorities and for the European Union Agency for Law Enforcement Cooperation (Europol) to access the EES, VIS, ETIAS and Eurodac for the purposes of the prevention, detection or investigation of terrorist offences or of other serious criminal offences. 5. This Regulation also lays down a framework for verifying the identity of persons and for identifying persons. Article 2 Objectives 1. By ensuring interoperability, this Regulation has the following objectives: (a) to improve the effectiveness and efficiency of border checks at external borders; (b) to contribute to the prevention and the combating of illegal immigration; (c) to contribute to a high level of security within the area of freedom, security and justice of the Union including the maintenance of public security and public policy and safeguarding security in the territories of the Member States; (d) to improve the implementation of the common visa policy; (e) to assist in the examination of applications for international protection; (f) to contribute to the prevention, detection and investigation of terrorist offences and of other serious criminal offences; (g) to facilitate the identification of unknown persons who are unable to identify themselves or unidentified human remains in case of a natural disaster, accident or terrorist attack. 2. The objectives referred to in paragraph 1 shall be achieved by: (a) ensuring the correct identification of persons; (b) contributing to combating identity fraud; (c) improving data quality and harmonising the quality requirements for the data stored in the EU information systems while respecting the data processing requirements of the legal instruments governing the individual systems, data protection standards and principles; (d) facilitating and supporting technical and operational implementation by Member States of EU information systems; (e) strengthening, simplifying and making more uniform the data security and data protection conditions that govern the respective EU information systems, without affecting the special protection and safeguards afforded to certain categories of data; (f) streamlining the conditions for designated authorities' access to the EES, VIS, ETIAS and Eurodac, while ensuring necessary and proportionate conditions for that access; (g) supporting the purposes of the EES, VIS, ETIAS, Eurodac, SIS and ECRIS-TCN. Article 3 Scope 1. This Regulation applies to the EES, VIS, ETIAS and SIS. 2. This Regulation applies to persons in respect of whom personal data may be processed in the EU information systems referred to in paragraph 1 of this Article and whose data are collected for the purposes defined in Articles 1 and 2 of Regulation (EC) No 767/2008, Article 1 of Regulation (EU) 2017/2226, Articles 1 and 4 of Regulation (EU) 2018/1240, Article 1 of Regulation (EU) 2018/1860 and Article 1 of Regulation (EU) 2018/1861. Article 4 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018external borders\u2019 means external borders as defined in point (2) of Article 2 of Regulation (EU) 2016/399; (2) \u2018border checks\u2019 means border checks as defined in point (11) of Article 2 of Regulation (EU) 2016/399; (3) \u2018border authority\u2019 means the border guard assigned in accordance with national law to carry out border checks; (4) \u2018supervisory authorities\u2019 means the supervisory authority referred to in Article 51(1) of Regulation (EU) 2016/679 and the supervisory authority referred to in Article 41(1) of Directive (EU) 2016/680; (5) \u2018verification\u2019 means the process of comparing sets of data to establish the validity of a claimed identity (one-to-one check); (6) \u2018identification\u2019 means the process of determining a person's identity through a database search against multiple sets of data (one-to-many check); (7) \u2018alphanumeric data\u2019 means data represented by letters, digits, special characters, spaces and punctuation marks; (8) \u2018identity data\u2019 means the data referred to in Article 27(3)(a) to (e); (9) \u2018fingerprint data\u2019 means fingerprint images and images of fingerprint latents, which due to their unique character and the reference points contained therein enable accurate and conclusive comparisons on a person's identity; (10) \u2018facial image\u2019 means digital images of the face; (11) \u2018biometric data\u2019 means fingerprint data or facial images or both; (12) \u2018biometric template\u2019 means a mathematical representation obtained by feature extraction from biometric data limited to the characteristics necessary to perform identifications and verifications; (13) \u2018travel document\u2019 means a passport or other equivalent document entitling the holder to cross the external borders and to which a visa can be affixed; (14) \u2018travel document data\u2019 means the type, number and country of issuance of the travel document, the date of expiry of the validity of the travel document and the three-letter code of the country issuing the travel document; (15) \u2018EU information systems\u2019 means the EES, VIS, ETIAS, Eurodac, SIS and ECRIS-TCN; (16) \u2018Europol data\u2019 means personal data processed by Europol for the purpose referred to in Article 18(2)(a), (b) and (c) of Regulation (EU) 2016/794; (17) \u2018Interpol databases\u2019 means the Interpol Stolen and Lost Travel Document database (SLTD database) and the Interpol Travel Documents Associated with Notices database (TDAWN database); (18) \u2018match\u2019 means the existence of a correspondence as a result of an automated comparison between personal data recorded or being recorded in an information system or database; (19) \u2018police authority\u2019 means the competent authority as defined in point (7) of Article 3 of Directive (EU) 2016/680; (20) \u2018designated authorities\u2019 means the Member State designated authorities as defined in point (26) of Article 3(1) of Regulation (EU) 2017/2226, point (e) of Article 2(1) of Decision 2008/633/JHA and point (21) Article 3(1) of Regulation (EU) 2018/1240; (21) \u2018terrorist offence\u2019 means an offence under national law which corresponds or is equivalent to one of the offences referred to in Directive (EU) 2017/541 of the European Parliament and of the Council (35); (22) \u2018serious criminal offence\u2019 means an offence which corresponds or is equivalent to one of the offences referred to in Article 2(2) of Council Framework Decision 2002/584/JHA (36), if it is punishable under national law by a custodial sentence or a detention order for a maximum period of at least three years; (23) \u2018Entry/Exit System\u2019 or \u2018EES\u2019 means the Entry/Exit System established by Regulation (EU) 2017/2226; (24) \u2018Visa Information System\u2019 or \u2018VIS\u2019 means the Visa Information System established by Regulation (EC) No 767/2008; (25) \u2018European Travel Information and Authorisation System\u2019 or \u2018ETIAS\u2019 means the European Travel Information and Authorisation System established by Regulation (EU) 2018/1240; (26) \u2018Eurodac\u2019 means Eurodac established by Regulation (EU) No 603/2013 of the European Parliament and of the Council (37); (27) \u2018Schengen Information System\u2019 or \u2018SIS\u2019 means the Schengen Information System established by Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862; (28) \u2018ECRIS-TCN\u2019 means the centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons established by Regulation (EU) 2019/816 of the European Parliament and of the Council (38). Article 5 Non-discrimination and fundamental rights Processing of personal data for the purposes of this Regulation shall not result in discrimination against persons on any grounds such as gender, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation. It shall fully respect human dignity and integrity and fundamental rights, including the right to respect for one's private life and to the protection of personal data. Particular attention shall be paid to children, the elderly, persons with a disability and persons in need of international protection. The best interests of the child shall be a primary consideration. CHAPTER II European search portal Article 6 European search portal 1. A European search portal (ESP) is established for the purposes of facilitating the fast, seamless, efficient, systematic and controlled access of Member State authorities and Union agencies to the EU information systems, to Europol data and to the Interpol databases for the performance of their tasks and in accordance with their access rights and the objectives and purposes of the EES, VIS, ETIAS, Eurodac, SIS and ECRIS-TCN. 2. The ESP shall be composed of: (a) a central infrastructure, including a search portal enabling the simultaneous querying of the EES, VIS, ETIAS, Eurodac, SIS, ECRIS-TCN as well as of Europol data and the Interpol databases; (b) a secure communication channel between the ESP, Member States and Union agencies that are entitled to use the ESP; (c) a secure communication infrastructure between the ESP and the EES, VIS, ETIAS, Eurodac, Central SIS, ECRIS-TCN, Europol data and the Interpol databases as well as between the ESP and the central infrastructures of the CIR and the MID. 3. eu-LISA shall develop the ESP and ensure its technical management. Article 7 Use of the European search portal 1. The use of the ESP shall be reserved to the Member State authorities and Union agencies having access to at least one of the EU information systems in accordance with the legal instruments governing those EU information systems, to the CIR and the MID in accordance with this Regulation, to Europol data in accordance with Regulation (EU) 2016/794 or to the Interpol databases in accordance with Union or national law governing such access. Those Member State authorities and Union agencies may make use of the ESP and the data provided by it only for the objectives and purposes laid down in the legal instruments governing those EU information systems, in Regulation (EU) 2016/794 and in this Regulation. 2. The Member State authorities and Union agencies referred to in paragraph 1 shall use the ESP to search data related to persons or their travel documents in the central systems of the EES, VIS and ETIAS in accordance with their access rights as referred to in the legal instruments governing those EU information systems and in national law. They shall also use the ESP to query the CIR in accordance with their access rights under this Regulation for the purposes referred to in Articles 20, 21 and 22. 3. The Member State authorities referred to in paragraph 1 may use the ESP to search data related to persons or their travel documents in the Central SIS referred to in Regulations (EU) 2018/1860 and (EU) 2018/1861. 4. Where provided for under Union law, the Union agencies referred to in paragraph 1 shall use the ESP to search data related to persons or their travel documents in the Central SIS. 5. The Member State authorities and Union agencies referred to in paragraph 1 may use the ESP to search data related to travel documents in the Interpol databases, where provided for and in accordance with their access rights under Union and national law. Article 8 Profiles for the users of the European search portal 1. For the purposes of enabling the use of the ESP, eu-LISA shall, in cooperation with Member States, create a profile based on each category of ESP user and on the purposes of the queries, in accordance with the technical details and access rights referred to in paragraph 2. Each profile shall, in accordance with Union and national law, comprise the following information: (a) the fields of data to be used for querying; (b) the EU information systems, Europol data and the Interpol databases that are to be queried, those that can be queried and those that are to provide a reply to the user; (c) the specific data in the EU information systems, Europol data and the Interpol databases that may be queried; (d) the categories of data that may be provided in each reply. 2. The Commission shall adopt implementing acts to specify the technical details of the profiles referred to in paragraph 1 in accordance with the ESP users' access rights under the legal instruments governing the EU information systems and under national law. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2). 3. The profiles referred to in paragraph 1 shall be reviewed regularly by eu-LISA in cooperation with Member States, at least once per year, and if necessary updated. Article 9 Queries 1. The ESP users shall launch a query by submitting alphanumeric or biometric data to the ESP. Where a query has been launched, the ESP shall query the EES, ETIAS, VIS, SIS, Eurodac, ECRIS-TCN, the CIR, Europol data and the Interpol databases simultaneously with the data submitted by the user and in accordance with the user profile. 2. The categories of data used to launch a query via the ESP shall correspond to the categories of data related to persons or travel documents that may be used to query the various EU information systems, Europol data and the Interpol databases in accordance with the legal instruments governing them. 3. eu-LISA, in cooperation with Member States, shall implement an interface control document based on the UMF referred to in Article 38 for the ESP. 4. When a query is launched by an ESP user, the EES, ETIAS, VIS, SIS, Eurodac, ECRIS-TCN, the CIR, the MID, the Europol data and the Interpol databases shall in reply to the query provide the data that they hold. Without prejudice to Article 20, the reply provided by the ESP shall indicate to which EU information system or database the data belong. The ESP shall provide no information regarding data in EU information systems, Europol data and the Interpol databases to which the user has no access under the applicable Union and national law. 5. Any queries of the Interpol databases launched via the ESP shall be performed in such a way that no information shall be revealed to the owner of the Interpol alert. 6. The ESP shall provide replies to the user as soon as data are available from one of the EU information systems, Europol data or Interpol databases. Those replies shall contain only the data to which the user has access under Union and national law. 7. The Commission shall adopt an implementing act to specify the technical procedure for the ESP to query the EU information systems, Europol data and Interpol databases and the format of the ESP replies. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 74(2). Article 10 Keeping of logs 1. Without prejudice to Article 46 of Regulation (EU) 2017/2226, Article 34 of Regulation (EC) No 767/2008, Article 69 of Regulation (EU) 2018/1240 and Articles 12 and 18 of Regulation (EU) 2018/1861, eu-LISA shall keep logs of all data processing operations in the ESP. Those logs shall include the following: (a) the Member State or Union agency launching the query and the ESP profile used; (b) the date and time of the query; (c) the EU information systems and the Interpol databases queried. 2. Each Member State shall keep logs of queries that its authorities and the staff of those authorities duly authorised to use the ESP make. Each Union agency shall keep logs of queries that its duly authorised staff make. 3. The logs referred to in paragraphs 1 and 2 may be used only for data protection monitoring, including checking the admissibility of a query and the lawfulness of data processing, and for ensuring data security and integrity. Those logs shall be protected by appropriate measures against unauthorised access and erased one year after their creation. If, however, they are required for monitoring procedures that have already begun, they shall be erased once the monitoring procedures no longer require the logs. Article 11 Fall-back procedures in case of technical impossibility to use the European search portal 1. Where it is technically impossible to use the ESP to query one or several EU information systems or the CIR, because of a failure of the ESP, the ESP users shall be notified in an automated manner by eu-LISA. 2. Where it is technically impossible to use the ESP to query one or several EU information systems or the CIR, because of a failure of the national infrastructure in a Member State, that Member State shall notify eu-LISA and the Commission in an automated manner. 3. In the cases referred to in paragraphs 1 or 2 of this Article, and until the technical failure is addressed, the obligation referred to in Article 7(2) and (4) shall not apply and Member States shall access the EU information systems or the CIR directly where they are required to do so under Union or national law. 4. Where it is technically impossible to use the ESP to query one or several EU information systems or the CIR, because of a failure of the infrastructure of a Union agency, that agency shall notify eu-LISA and the Commission in an automated manner. CHAPTER III Shared biometric matching service Article 12 Shared biometric matching service 1. A shared biometric matching service (shared BMS) storing biometric templates obtained from the biometric data referred to in Article 13 that are stored in the CIR and SIS and enabling querying with biometric data across several EU information systems is established for the purposes of supporting the CIR and the MID and the objectives of the EES, VIS, Eurodac, SIS and ECRIS-TCN. 2. The shared BMS shall be composed of: (a) a central infrastructure, which shall replace the central systems of the EES, VIS, SIS, Eurodac and ECRIS-TCN respectively, to the extent that it shall store biometric templates and allow searches with biometric data; (b) a secure communication infrastructure between the shared BMS, Central SIS and the CIR. 3. eu-LISA shall develop the shared BMS and ensure its technical management. Article 13 Storing biometric templates in the shared biometric matching service 1. The shared BMS shall store the biometric templates, which it shall obtain from the following biometric data: (a) the data referred to in Article 16(1)(d), Article 17(1)(b) and (c) and Article 18(2)(a), (b) and (c) of Regulation (EU) 2017/2226; (b) the data referred to in point (6) of Article 9 of Regulation (EC) No 767/2008; (c) the data referred to in Article 20(2)(w) and (x), excluding data on palm prints, of Regulation (EU) 2018/1861; (d) the data referred to in Article 4(1)(u) and (v), excluding data on palm prints, of Regulation (EU) 2018/1860. The biometric templates shall be stored in the shared BMS in logically separated form according to the EU information system from which the data originate. 2. For each set of data referred to in paragraph 1, the shared BMS shall include in each biometric template a reference to the EU information systems in which the corresponding biometric data are stored and a reference to the actual records in those EU information systems. 3. Biometric templates shall only be entered in the shared BMS following an automated quality check of the biometric data added to one of the EU information systems performed by the shared BMS to ascertain the fulfilment of a minimum data quality standard. 4. The storage of the data referred to in paragraph 1 shall meet the quality standards referred to in Article 37(2). 5. The Commission shall lay down, by means of an implementing act, the performance requirements and practical arrangements for monitoring the performance of the shared BMS in order to ensure that the effectiveness of biometric searches respect time-critical procedures such as border checks and identifications. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 74(2). Article 14 Searching biometric data with the shared biometric matching service In order to search the biometric data stored within the CIR and SIS, the CIR and SIS shall use the biometric templates stored in the shared BMS. Queries with biometric data shall take place in accordance with the purposes provided for in this Regulation and in Regulations (EC) No 767/2008, (EU) 2017/2226, (EU) 2018/1860, (EU) 2018/1861, (EU) 2018/1862 and (EU) 2019/816. Article 15 Data retention in the shared biometric matching service The data referred to in Article 13(1) and (2) shall be stored in the shared BMS only for as long as the corresponding biometric data are stored in the CIR or SIS. The data shall be erased from the shared BMS in an automated manner. Article 16 Keeping of logs 1. Without prejudice to Article 46 of Regulation (EU) 2017/2226, Article 34 of Regulation (EC) No 767/2008 and Articles 12 and 18 of Regulation (EU) 2018/1861, eu-LISA shall keep logs of all data processing operations in the shared BMS. Those logs shall include the following: (a) the Member State or Union agency launching the query; (b) the history of the creation and storage of biometric templates; (c) the EU information systems queried with the biometric templates stored in the shared BMS; (d) the date and time of the query; (e) the type of biometric data used to launch the query; (f) the results of the query and date and time of the result. 2. Each Member State shall keep logs of queries that its authorities and the staff of those authorities duly authorised to use the shared BMS make. Each Union agency shall keep logs of queries that its duly authorised staff make. 3. The logs referred to in paragraphs 1 and 2 may be used only for data protection monitoring, including checking the admissibility of a query and the lawfulness of data processing, and for ensuring data security and integrity. Those logs shall be protected by appropriate measures against unauthorised access and erased one year after their creation. If, however, they are required for monitoring procedures that have already begun, they shall be erased once the monitoring procedures no longer require the logs. CHAPTER IV Common identity repository Article 17 Common identity repository 1. A common identity repository (CIR), creating an individual file for each person that is registered in the EES, VIS, ETIAS, Eurodac or ECRIS-TCN containing the data referred to in Article 18, is established for the purpose of facilitating and assisting in the correct identification of persons registered in the EES, VIS, ETIAS, Eurodac and ECRIS-TCN in accordance with Article 20, of supporting the functioning of the MID in accordance with Article 21 and of facilitating and streamlining access by designated authorities and Europol to the EES, VIS, ETIAS and Eurodac, where necessary for the prevention, detection or investigation of terrorist offences or other serious criminal offences in accordance with Article 22. 2. The CIR shall be composed of: (a) a central infrastructure that shall replace the central systems of respectively the EES, VIS, ETIAS, Eurodac and ECRIS-TCN to the extent that it shall store the data referred to in Article 18; (b) a secure communication channel between the CIR, Member States and Union agencies that are entitled to use the CIR in accordance with Union law and national law; (c) a secure communication infrastructure between the CIR and the EES, VIS, ETIAS, Eurodac and ECRIS-TCN as well as with the central infrastructures of the ESP, the shared BMS and the MID. 3. eu-LISA shall develop the CIR and ensure its technical management. 4. Where it is technically impossible because of a failure of the CIR to query the CIR for the purpose of identifying a person pursuant to Article 20, for the detection of multiple identities pursuant to Article 21 or for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences pursuant to Article 22, the CIR users shall be notified by eu-LISA in an automated manner. 5. eu-LISA, in cooperation with Member States, shall implement an interface control document based on the UMF referred to in Article 38 for the CIR. Article 18 The common identity repository data 1. The CIR shall store the following data, logically separated according to the information system from which the data have originated: (a) the data referred to in Article 16(1)(a) to (d), Article 17(1)(a), (b) and (c) and Article 18(1) and (2) of Regulation (EU) 2017/2226; (b) the data referred to in points (4)(a) to (c), (5) and (6) of Article 9 of Regulation (EC) No 767/2008; (c) the data referred to in Article 17(2)(a) to (e) of Regulation (EU) 2018/1240; 2. For each set of data referred to in paragraph 1, the CIR shall include a reference to the EU information systems to which the data belong. 3. The authorities accessing the CIR shall do so in accordance with their access rights under the legal instruments governing the EU information systems, and under national law and in accordance with their access rights under this Regulation for the purposes referred to in Articles 20, 21 and 22. 4. For each set of data referred to in paragraph 1, the CIR shall include a reference to the actual record in the EU information systems to which the data belong. 5. The storage of the data referred to in paragraph 1 shall meet the quality standards referred to in Article 37(2). Article 19 Adding, amending and deleting data in the common identity repository 1. Where data are added, amended or deleted in the EES, VIS and ETIAS, the data referred to in Article 18 stored in the individual file of the CIR shall be added, amended or deleted accordingly in an automated manner. 2. Where a white or red link is created in the MID in accordance with Article 32 or 33 between the data of two or more of the EU information systems constituting the CIR, instead of creating a new individual file, the CIR shall add the new data to the individual file of the linked data. Article 20 Access to the common identity repository for identification 1. Queries of the CIR shall be carried out by a police authority in accordance with paragraphs 2 and 5 only in the following circumstances: (a) where a police authority is unable to identify a person due to the lack of a travel document or another credible document proving that person's identity; (b) where there are doubts about the identity data provided by a person; (c) where there are doubts as to the authenticity of the travel document or another credible document provided by a person; (d) where there are doubts as to the identity of the holder of a travel document or of another credible document; or (e) where a person is unable or refuses to cooperate. Such queries shall not be allowed against minors under the age of 12 years old, unless in the best interests of the child. 2. Where one of the circumstances listed in paragraph 1 arises and a police authority has been so empowered by national legislative measures as referred to in paragraph 5, it may, solely for the purpose of identifying a person, query the CIR with the biometric data of that person taken live during an identity check, provided that the procedure was initiated in the presence of that person. 3. Where the query indicates that data on that person are stored in the CIR, the police authority shall have access to consult the data referred to in Article 18(1). Where the biometric data of the person cannot be used or where the query with that data fails, the query shall be carried out with identity data of the person in combination with travel document data, or with the identity data provided by that person. 4. Where a police authority has been so empowered by national legislative measures as referred to in paragraph 6, it may, in the event of a natural disaster, an accident or a terrorist attack and solely for the purpose of identifying unknown persons who are unable to identify themselves or unidentified human remains, query the CIR with the biometric data of those persons. 5. Member States wishing to avail themselves of the possibility provided for in paragraph 2 shall adopt national legislative measures. When doing so, Member States shall take into account the need to avoid any discrimination against third-country nationals. Such legislative measures shall specify the precise purposes of the identification within the purposes referred to in Article 2(1)(b) and (c). They shall designate the competent police authorities and lay down the procedures, conditions and criteria of such checks. 6. Member States wishing to avail themselves of the possibility provided for in paragraph 4 shall adopt national legislative measures laying down the procedures, conditions and criteria. Article 21 Access to the common identity repository for the detection of multiple identities 1. Where a query of the CIR results in a yellow link in accordance with Article 28(4), the authority responsible for the manual verification of different identities in accordance with Article 29 shall have access, solely for the purpose of that verification, to the data referred to in Article 18(1) and (2) stored in the CIR connected by a yellow link. 2. Where a query of the CIR results in a red link in accordance with Article 32, the authorities referred to in Article 26(2) shall have access, solely for the purposes of combating identity fraud, to the data referred to in Article 18(1) and (2) stored in the CIR connected by a red link. Article 22 Querying the common identity repository for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences 1. In a specific case, where there are reasonable grounds to believe that consultation of EU information systems will contribute to the prevention, detection or investigation of terrorist offences or other serious criminal offences, in particular where there is a suspicion that the suspect, perpetrator or victim of a terrorist offence or other serious criminal offences is a person whose data are stored in the EES, VIS or ETIAS, the designated authorities and Europol may consult the CIR in order to obtain information on whether data on a specific person are present in the EES, VIS or ETIAS. 2. Where in reply to a query the CIR indicates that data on that person are present in the EES, VIS or ETIAS, the CIR shall provide to designated authorities and Europol a reply in the form of a reference as referred to in Article 18(2) indicating which of those EU information systems contains matching data. The CIR shall reply in such a way that the security of the data is not compromised. The reply indicating that data on that person are present in any of the EU information systems referred to in paragraph 1 shall be used only for the purposes of submitting a request for full access subject to the conditions and procedures laid down in the respective legal instruments governing such access. In the event of a match or multiple matches, the designated authority or Europol shall make a request for full access to at least one of the information systems from which a match was generated. Where exceptionally, such full access is not requested, the designated authorities shall record the justification for not making the request, which shall be traceable to the national file. Europol shall record the justification in the relevant file. 3. Full access to the data contained in the EES, VIS or ETIAS for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences remains subject to the conditions and procedures laid down in the respective legal instruments governing such access. Article 23 Data retention in the common identity repository 1. The data referred to in Article 18(1), (2) and (4) shall be deleted from the CIR in an automated manner in accordance with the data retention provisions of Regulations (EU) 2017/2226, (EC) No 767/2008 and (EU) 2018/1240 respectively. 2. The individual file shall be stored in the CIR only for as long as the corresponding data are stored in at least one of the EU information systems whose data are contained in the CIR. The creation of a link shall not affect the retention period of each item of the linked data. Article 24 Keeping of logs 1. Without prejudice to Article 46 of Regulation (EU) 2017/2226, Article 34 of Regulation (EC) No 767/2008 and Article 69 of Regulation (EU) 2018/1240, eu-LISA shall keep logs of all data processing operations in the CIR in accordance with paragraphs 2, 3 and 4 of this Article. 2. eu-LISA shall keep logs of all data processing operations pursuant to Article 20 in the CIR. Those logs shall include the following: (a) the Member State or Union agency launching the query; (b) the purpose of access of the user querying via the CIR; (c) the date and time of the query; (d) the type of data used to launch the query; (e) the results of the query. 3. eu-LISA shall keep logs of all data processing operations pursuant to Article 21 in the CIR. Those logs shall include the following: (a) the Member State or Union agency launching the query; (b) the purpose of access of the user querying via the CIR; (c) the date and time of the query; (d) where a link is created, the data used to launch the query and the results of the query indicating the EU information system from which the data were received. 4. eu-LISA shall keep logs of all data processing operations pursuant to Article 22 in the CIR. Those logs shall include the following: (a) the date and time of the query; (b) the data used to launch the query; (c) the results of the query; (d) the Member State or Union agency querying the CIR. The logs of such access shall be regularly verified by the competent supervisory authority in accordance with Article 41 of Directive (EU) 2016/680 or by the European Data Protection Supervisor in accordance with Article 43 of Regulation (EU) 2016/794, at intervals not exceeding six months, to verify whether the procedures and conditions set out in Article 22(1) and (2) of this Regulation are fulfilled. 5. Each Member State shall keep logs of queries that its authorities and the staff of those authorities duly authorised to use the CIR make pursuant to Articles 20, 21 and 22. Each Union agency shall keep logs of queries that its duly authorised staff make pursuant to Articles 21 and 22. In addition, for any access to the CIR pursuant to Article 22, each Member State shall keep the following logs: (a) the national file reference; (b) the purpose of access; (c) in accordance with national rules, the unique user identity of the official who carried out the query and of the official who ordered the query. 6. In accordance with Regulation (EU) 2016/794, for any access to the CIR pursuant to Article 22 of this Regulation, Europol shall keep logs of the unique user identity of the official who carried out the query and of the official who ordered the query. 7. The logs referred to in paragraphs 2 to 6 may be used only for data protection monitoring, including checking the admissibility of a query and the lawfulness of data processing, and for ensuring data security and integrity. Those logs shall be protected by appropriate measures against unauthorised access and erased one year after their creation. If, however, they are required for monitoring procedures that have already begun, they shall be erased once the monitoring procedures no longer require the logs. 8. eu-LISA shall store the logs related to the history of the data, in individual files. eu-LISA shall erase such logs in an automated manner, once the data are erased. CHAPTER V Multiple-identity detector Article 25 Multiple-identity detector 1. A multiple-identity detector (MID) creating and storing identity confirmation files as referred to in Article 34, containing links between data in the EU information systems included in the CIR and SIS and allowing detection of multiple identities, with the dual purpose of facilitating identity checks and combating identity fraud, is established for the purpose of supporting the functioning of the CIR and the objectives of the EES, VIS, ETIAS, Eurodac, SIS and ECRIS-TCN. 2. The MID shall be composed of: (a) a central infrastructure, storing links and references to EU information systems; (b) a secure communication infrastructure to connect the MID with SIS and the central infrastructures of the ESP and the CIR. 3. eu-LISA shall develop the MID and ensure its technical management. Article 26 Access to the multiple-identity detector 1. For the purposes of the manual verification of different identities referred to in Article 29, access to the data referred to in Article 34 stored in the MID shall be granted to: (a) competent authorities designated in accordance with Article 9(2) of Regulation (EU) 2017/2226 when creating or updating an individual file in the EES in accordance with Article 14 of that Regulation; (b) the visa authorities referred to in Article 6(1) of Regulation (EC) No 767/2008 when creating or updating an application file in VIS in accordance with that Regulation; (c) the ETIAS Central Unit and the ETIAS National Units when carrying out the processing referred to in Articles 22 and 26 of Regulation (EU) 2018/1240; (d) the SIRENE Bureau of the Member State creating or updating a SIS alert in accordance with Regulations (EU) 2018/1860 and (EU) 2018/1861. 2. Member State authorities and Union agencies having access to at least one EU information system included in the CIR or to SIS shall have access to the data referred to in Article 34(a) and (b) regarding any red links referred to in Article 32. 3. Member State authorities and Union agencies shall have access to the white links referred to in Article 33 where they have access to the two EU information systems containing data between which the white link was created. 4. Member State authorities and Union agencies shall have access to the green links referred to in Article 31 where they have access to the two EU information systems containing data between which the green link was created and a query of those information systems has revealed a match with the two sets of linked data. Article 27 Multiple-identity detection 1. Multiple-identity detection in the CIR and SIS shall be launched where: (a) an individual file is created or updated in the EES in accordance with Article 14 of Regulation (EU) 2017/2226; (b) an application file is created or updated in VIS in accordance with Regulation (EC) No 767/2008; (c) an application file is created or updated in ETIAS in accordance with Article 19 of Regulation (EU) 2018/1240; (d) an alert on a person is created or updated in SIS in accordance with Article 3 of Regulation (EU) 2018/1860 and Chapter V of Regulation (EU) 2018/1861. 2. Where the data contained within an EU information system referred to in paragraph 1 contains biometric data, the CIR and Central SIS shall use the shared BMS in order to perform multiple-identity detection. The shared BMS shall compare the biometric templates obtained from any new biometric data to the biometric templates already contained in the shared BMS in order to verify whether data belonging to the same person are already stored in the CIR or in Central SIS. 3. In addition to the process referred to in paragraph 2, the CIR and Central SIS shall use the ESP to search the data stored in Central SIS and the CIR respectively using the following data: (a) surname (family name); first name or names (given names); date of birth; nationality or nationalities; and sex; as referred to in Articles 16(1)(a), 17(1) and 18(1) of Regulation (EU) 2017/2226; (b) surname (family name); first name or names (given names); date of birth; sex; place and country of birth; and nationalities; as referred to in point (4)(a) and (aa) of Article 9 of Regulation (EC) No 767/2008; (c) surname (family name), first name(s) (given name(s)), surname at birth; alias(es); date of birth, place of birth, sex and current nationality; as referred to in Article 17(2) of Regulation (EU) 2018/1240; (d) surnames, forenames, names at birth, previously used names and aliases, place of birth, date of birth, gender and any nationalities held, as referred to in Article 20(2) of Regulation (EU) 2018/1861; (e) surnames, forenames, names at birth, previously used names and aliases, place of birth, date of birth, gender and any nationalities held, as referred to in Article 4 of Regulation (EU) 2018/1860. 4. In addition to the process referred to in paragraphs 2 and 3, the CIR and Central SIS shall use the ESP to search the data stored in Central SIS and the CIR respectively using travel document data. 5. The multiple-identity detection shall only be launched in order to compare data available in one EU information system with data available in other EU information systems. Article 28 Results of the multiple-identity detection 1. Where the queries referred to in Article 27(2), (3) and (4) do not report any match, the procedures referred to in Article 27(1) shall continue in accordance with the legal instruments governing them. 2. Where the query laid down in Article 27(2), (3) and (4) reports one or several matches, the CIR and, where relevant, SIS shall create a link between the data used to launch the query and the data triggering the match. Where several matches are reported, a link shall be created between all data triggering the match. Where the data were already linked, the existing link shall be extended to the data used to launch the query. 3. Where the query referred to in Article 27(2), (3) and (4) reports one or several matches and the identity data of the linked files are the same or similar, a white link shall be created in accordance with Article 33. 4. Where the query referred to in Article 27(2), (3) and (4) reports one or several matches and the identity data of the linked files cannot be considered to be similar, a yellow link shall be created in accordance with Article 30 and the procedure referred to in Article 29 shall apply. 5. The Commission shall adopt delegated acts in accordance with Article 73 laying down the procedures to determine the cases in which identity data can be considered to be the same or similar. 6. The links shall be stored in the identity confirmation file referred to in Article 34. 7. The Commission shall, in cooperation with eu-LISA, lay down the technical rules for creating links between data from different EU information systems, by implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2). Article 29 Manual verification of different identities and the authorities responsible 1. Without prejudice to paragraph 2, the authority responsible for manual verification of different identities shall be: (a) the competent authority designated in accordance with Article 9(2) of Regulation (EU) 2017/2226 for matches that occurred when creating or updating an individual file in the EES in accordance with that Regulation; (b) the visa authorities referred to in Article 6(1) of Regulation (EC) No 767/2008 for matches that occurred when creating or updating an application file in VIS in accordance with that Regulation; (c) the ETIAS Central Unit and the ETIAS National Units for matches that occurred when creating or updating an application file in accordance with Regulation (EU) 2018/1240; (d) the SIRENE Bureau of the Member State for matches that occurred when creating or updating a SIS alert in accordance with Regulations (EU) 2018/1860 and (EU) 2018/1861. The MID shall indicate the authority responsible for the manual verification of different identities in the identity confirmation file. 2. The authority responsible for the manual verification of different identities in the identity confirmation file shall be the SIRENE Bureau of the Member State that created the alert where a link is created to data contained in an alert: (a) in respect of persons wanted for arrest for surrender or extradition purposes referred to in Article 26 of Regulation (EU) 2018/1862; (b) on missing or vulnerable persons referred to in Article 32 of Regulation (EU) 2018/1862; (c) on persons sought to assist with a judicial procedure referred to in Article 34 of Regulation (EU) 2018/1862; (d) on persons for discreet checks, inquiry checks or specific checks referred to in Article 36 of Regulation (EU) 2018/1862. 3. Without prejudice to paragraph 4 of this Article, the authority responsible for the manual verification of different identities shall have access to the linked data contained in the relevant identity confirmation file and to the identity data linked in the CIR and, where relevant, in SIS. It shall assess the different identities without delay. Once such assessment is completed, it shall update the link in accordance with Articles 31, 32 and 33 and add it to the identity confirmation file without delay. 4. Where the authority responsible for the manual verification of different identities in the identity confirmation file is the competent authority designated in accordance with Article 9(2) of Regulation (EU) 2017/2226 creating or updating an individual file in the EES in accordance with Article 14 of that Regulation, and where a yellow link is created, that authority shall carry out additional verifications. That authority shall, for that purpose only, have access to the related data contained in the relevant identity confirmation file. It shall assess the different identities, update the link in accordance with Articles 31, 32 and 33 of this Regulation and add it to the identity confirmation file without delay. Such manual verification of different identities shall be initiated in the presence of the person concerned, who shall be offered the opportunity to explain the circumstances to the authority responsible, which shall take those explanations into account. In cases in which the manual verification of different identities takes place at the border, it shall take place within 12 hours from the creation of a yellow link under Article 28(4), where possible. 5. Where more than one link is created, the authority responsible for the manual verification of different identities shall assess each link separately. 6. Where data reporting a match were already linked, the authority responsible for the manual verification of different identities shall take into account the existing links when assessing the creation of new links. Article 30 Yellow link 1. Where manual verification of different identities has not yet taken place, a link between data from two or more EU information systems shall be classified as yellow in any of the following cases: (a) the linked data share the same biometric data but have similar or different identity data; (b) the linked data have different identity data but share the same travel document data, and at least one of the EU information systems does not contain biometric data on the person concerned; (c) the linked data share the same identity data but have different biometric data; (d) the linked data have similar or different identity data, and share the same travel document data, but have different biometric data. 2. Where a link is classified as yellow in accordance with paragraph 1, the procedure laid down in Article 29 applies. Article 31 Green link 1. A link between data from two or more EU information systems shall be classified as green where: (a) the linked data have different biometric data but share the same identity data and the authority responsible for the manual verification of different identities has concluded that the linked data refer to two different persons; (b) the linked data have different biometric data, have similar or different identity data, share the same travel document data and the authority responsible for the manual verification of different identities has concluded that the linked data refer to two different persons; (c) the linked data have different identity data but share the same travel document data, at least one of the EU information systems does not contain biometric data on the person concerned and the authority responsible for the manual verification of different identities has concluded that the linked data refer to two different persons. 2. Where the CIR or SIS are queried and where a green link exists between data in two or more of the EU information systems, the MID shall indicate that the identity data of the linked data do not correspond to the same person. 3. If a Member State authority has evidence to suggest that a green link has been incorrectly recorded in the MID, that a green link is out of date or that data were processed in the MID or the EU information systems in breach of this Regulation, it shall check the relevant data stored in the CIR and SIS and shall, if necessary, rectify or erase the link from the MID without delay. That Member State authority shall inform the Member State responsible for the manual verification of different identities without delay. Article 32 Red link 1. A link between data from two or more EU information systems shall be classified as red in any of the following cases: (a) the linked data share the same biometric data but have similar or different identity data and the authority responsible for the manual verification of different identities has concluded that the linked data refer to the same person in an unjustified manner; (b) the linked data have the same, similar or different identity data and the same travel document data, but different biometric data and the authority responsible for the manual verification of different identities has concluded that the linked data refer to two different persons, at least one of whom is using the same travel document in an unjustified manner; (c) the linked data share the same identity data, but have different biometric data and different or no travel document data and the authority responsible for the manual verification of different identities has concluded that the linked data refer to two different persons in an unjustified manner; (d) the linked data have different identity data, but share the same travel document data, at least one of the EU information systems does not contain biometric data on the person concerned and the authority responsible for the manual verification of different identities has concluded that the linked data refer to the same person in an unjustified manner. 2. Where the CIR or SIS are queried and where a red link exists between data in two or more of the EU information systems, the MID shall indicate the data referred to in Article 34. Follow-up to a red link shall take place in accordance with Union and national law, with any legal consequence for the person concerned being based only on the relevant data on that person. No legal consequence for the person concerned shall derive solely from the existence of a red link. 3. Where a red link is created between data in the EES, VIS, ETIAS, Eurodac or ECRIS-TCN, the individual file stored in the CIR shall be updated in accordance with Article 19(2). 4. Without prejudice to the provisions related to the handling of alerts in SIS contained in Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862, and without prejudice to limitations necessary to protect security and public order, prevent crime and guarantee that no national investigation will be jeopardised, where a red link is created, the authority responsible for the manual verification of different identities shall inform the person concerned of the presence of multiple unlawful identity data and shall provide the person with the single identification number referred to in Article 34(c) of this Regulation, a reference to the authority responsible for the manual verification of different identities referred to in Article 34(d) of this Regulation and the website address of the web portal established in accordance with Article 49 of this Regulation. 5. The information referred to in paragraph 4 shall be provided in writing by means of a standard form by the authority responsible for the manual verification of different identities. The Commission shall determine the content and presentation of that form by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2). 6. Where a red link is created, the MID shall notify the authorities responsible for the linked data in an automated manner. 7. If a Member State authority or Union agency having access to the CIR or SIS has evidence to suggest that a red link has been incorrectly recorded in the MID or that data were processed in the MID, the CIR or SIS in breach of this Regulation, that authority or agency shall check the relevant data stored in the CIR and SIS and shall: (a) where the link relates to one of the SIS alerts referred to in Article 29(2), immediately inform the relevant SIRENE Bureau of the Member State that created the SIS alert; (b) in all other cases, either rectify or erase the link from the MID immediately. If a SIRENE Bureau is contacted pursuant to point (a) of the first subparagraph, it shall verify the evidence provided by the Member State authority or the Union agency and where relevant rectify or erase the link from the MID immediately. The Member State authority obtaining the evidence shall inform the Member State authority responsible for the manual verification of different identities without delay of any relevant rectification or erasure of a red link. Article 33 White link 1. A link between data from two or more EU information systems shall be classified as white in any of the following cases: (a) the linked data share the same biometric data and the same or similar identity data; (b) the linked data share the same or similar identity data, the same travel document data, and at least one of the EU information systems does not have biometric data on the person concerned; (c) the linked data share the same biometric data, the same travel document data and similar identity data; (d) the linked data share the same biometric data but have similar or different identity data and the authority responsible for the manual verification of different identities has concluded that linked data refer to the same person in a justified manner. 2. Where the CIR or SIS are queried and where a white link exists between data in two or more of the EU information systems, the MID shall indicate that the identity data of the linked data correspond to the same person. The queried EU information systems shall reply indicating, where relevant, all the linked data on the person, thereby triggering a match against the data that are linked by the white link, if the authority launching the query has access to the linked data under Union or national law. 3. Where a white link is created between data in the EES, VIS, ETIAS, Eurodac or ECRIS-TCN, the individual file stored in the CIR shall be updated in accordance with Article 19(2). 4. Without prejudice to the provisions related to the handling of alerts in SIS contained in Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862, and without prejudice to limitations necessary to protect security and public order, prevent crime and guarantee that no national investigation will be jeopardised, where a white link is created following a manual verification of different identities, the authority responsible for the manual verification of different identities shall inform the person concerned of the presence of similar or different identity data and shall provide the person with the single identification number referred to in Article 34(c) of this Regulation, a reference to the authority responsible for the manual verification of different identities referred to in Article 34(d) of this Regulation and the website address of the web portal established in accordance with Article 49 of this Regulation. 5. If a Member State authority has evidence to suggest that a white link has been incorrectly recorded in the MID, that a white link is out of date or that data were processed in the MID or the EU information systems in breach of this Regulation, it shall check the relevant data stored in the CIR and SIS and shall, if necessary, rectify or erase the link from the MID without delay. That Member State authority shall inform the Member State responsible for the manual verification of different identities without delay. 6. The information referred to in paragraph 4 shall be in writing by means of a standard form by the authority responsible for the manual verification of different identities. The Commission shall determine the content and presentation of that form by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2). Article 34 Identity confirmation file The identity confirmation file shall contain the following data: (a) the links referred to in Articles 30 to 33; (b) a reference to the EU information systems in which the linked data are held; (c) a single identification number allowing retrieval of the linked data from the corresponding EU information systems; (d) the authority responsible for the manual verification of different identities; (e) the date of creation of the link or of any update to it. Article 35 Data retention in the multiple-identity detector The identity confirmation files and the data in them, including the links, shall be stored in the MID only for as long as the linked data are stored in two or more EU information systems. They shall be erased from the MID in an automated manner. Article 36 Keeping of logs 1. eu-LISA shall keep logs of all data processing operations in the MID. Those logs shall include the following: (a) the Member State launching the query; (b) the purpose of user's access; (c) the date and time of the query; (d) the type of data used to launch the query; (e) the reference to the linked data; (f) the history of the identity confirmation file. 2. Each Member State shall keep logs of queries that its authorities and the staff of those authorities duly authorised to use the MID make. Each Union agency shall keep logs of queries that its duly authorised staff make. 3. The logs referred to in paragraphs 1 and 2 may be used only for data protection monitoring, including checking the admissibility of a query and the lawfulness of data processing, and for ensuring data security and integrity. Those logs shall be protected by appropriate measures against unauthorised access and erased one year after their creation. If, however, they are required for monitoring procedures that have already begun, they shall be erased once the monitoring procedures no longer require the logs. CHAPTER VI Measures supporting interoperability Article 37 Data quality 1. Without prejudice to Member States' responsibilities with regard to the quality of data entered into the systems, eu-LISA shall establish automated data quality control mechanisms and procedures on the data stored in the EES, VIS, ETIAS, SIS, the shared BMS and the CIR. 2. eu-LISA shall implement mechanisms for evaluating the accuracy of the shared BMS, common data quality indicators and the minimum quality standards for storage of data in the EES, VIS, ETIAS, SIS, the shared BMS and the CIR. Only data fulfilling the minimum quality standards may be entered in the EES, VIS, ETIAS, SIS, the shared BMS, the CIR and the MID. 3. eu-LISA shall provide regular reports on the automated data quality control mechanisms and procedures and the common data quality indicators to the Member States. eu-LISA shall also provide a regular report to the Commission covering the issues encountered and the Member States concerned. eu-LISA shall also provide that report to the European Parliament and to the Council upon request. No reports provided under this paragraph shall contain any personal data. 4. The details of the automated data quality control mechanisms and procedures, the common data quality indicators and the minimum quality standards for storage of data in the EES, VIS, ETIAS, SIS, the shared BMS and the CIR, in particular regarding biometric data, shall be laid down in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2). 5. One year after the establishment of the automated data quality control mechanisms and procedures, common data quality indicators and the minimum data quality standards, and every year thereafter, the Commission shall evaluate Member States' implementation of data quality and make any necessary recommendations. The Member States shall provide the Commission with an action plan to remedy any deficiencies identified in the evaluation report and, in particular, data quality issues deriving from erroneous data in EU information systems. The Member States shall regularly report to the Commission on any progress against this action plan until it is fully implemented. The Commission shall transmit the evaluation report to the European Parliament, to the Council, to the European Data Protection Supervisor, to the European Data Protection Board and to the European Union Agency for Fundamental Rights established by Council Regulation (EC) No 168/2007 (39). Article 38 Universal message format 1. The universal message format (UMF) standard is hereby established. The UMF defines standards for certain content elements of cross-border information exchange between information systems, authorities or organisations in the field of Justice and Home Affairs. 2. The UMF standard shall be used in the development of the EES, ETIAS, the ESP, the CIR, the MID and, if appropriate, in the development by eu-LISA or by any other Union agency of new information exchange models and information systems in the area of Justice and Home Affairs. 3. The Commission shall adopt an implementing act to lay down and develop the UMF standard referred to in paragraph 1 of this Article. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 74(2). Article 39 Central repository for reporting and statistics 1. A central repository for reporting and statistics (CRRS) is established for the purposes of supporting the objectives of the EES, VIS, ETIAS and SIS, in accordance with the respective legal instruments governing those systems, and to provide cross-system statistical data and analytical reporting for policy, operational and data quality purposes. 2. eu-LISA shall establish, implement and host in its technical sites the CRRS containing the data and statistics referred to in Article 63 of Regulation (EU) 2017/2226, Article 17 of Regulation (EC) No 767/2008, Article 84 of Regulation (EU) 2018/1240, Article 60 of Regulation (EU) 2018/1861 and Article 16 of Regulation (EU) 2018/1860, logically separated by EU information system. Access to the CRRS shall be granted by means of controlled, secured access and specific user profiles, solely for the purpose of reporting and statistics, to the authorities referred to in Article 63 of Regulation (EU) 2017/2226, Article 17 of Regulation (EC) No 767/2008, Article 84 of Regulation (EU) 2018/1240 and Article 60 of Regulation (EU) 2018/1861. 3. eu-LISA shall render the data anonymous and shall record such anonymised data in the CRRS. The process for rendering the data anonymous shall be automated. The data contained in CRRS shall not allow for the identification of individuals. 4. The CRRS shall be composed of: (a) the tools necessary for anonymising data; (b) a central infrastructure, consisting of a data repository of anonymous data; (c) a secure communication infrastructure to connect the CRRS to the EES, VIS, ETIAS and SIS, as well as the central infrastructures of the shared BMS, the CIR and the MID. 5. The Commission shall adopt a delegated act in accordance with Article 73 laying down detailed rules on the operation of the CRRS, including specific safeguards for the processing of personal data under paragraphs 2 and 3 of this Article and security rules applicable to the repository. CHAPTER VII Data protection Article 40 Data controller 1. In relation to the processing of data in the shared BMS, the Member State authorities that are controllers for the EES, VIS and SIS respectively shall be controllers in accordance with point (7) of Article 4 of Regulation (EU) 2016/679 or point (8) of Article 3 of Directive (EU) 2016/680 in relation to the biometric templates obtained from the data referred to in Article 13 of this Regulation that they enter into the underlying systems and shall have responsibility for the processing of the biometric templates in the shared BMS. 2. In relation to the processing of data in the CIR, the Member State authorities that are controllers for the EES, VIS and ETIAS respectively, shall be controllers in accordance with point (7) of Article 4 of Regulation (EU) 2016/679 in relation to data referred to in Article 18 of this Regulation that they enter into the underlying systems and shall have responsibility for the processing of those personal data in the CIR. 3. In relation to the processing of data in the MID: (a) the European Border and Coast Guard Agency shall be a data controller within the meaning of point (8) of Article 3 of Regulation (EU) 2018/1725 in relation to the processing of personal data by the ETIAS Central Unit; (b) the Member State authorities adding or modifying the data in the identity confirmation file shall be controllers in accordance with point (7) of Article 4 of Regulation (EU) 2016/679 or point (8) of Article 3 of Directive (EU) 2016/680 and shall have responsibility for the processing of the personal data in the MID. 4. For the purposes of data protection monitoring, including checking the admissibility of a query and the lawfulness of data processing, the data controllers shall have access to the logs referred to in Articles 10, 16, 24 and 36 for self-monitoring as referred to in Article 44. Article 41 Data processor In relation to the processing of personal data in the shared BMS, the CIR and the MID, eu-LISA shall be the data processor within the meaning of point (12)(a) of Article 3 of Regulation (EU) 2018/1725. Article 42 Security of processing 1. eu-LISA, the ETIAS Central Unit, Europol and the Member State authorities shall ensure the security of the processing of personal data that takes place pursuant to this Regulation. eu-LISA, the ETIAS Central Unit, Europol and the Member State authorities shall cooperate on security-related tasks. 2. Without prejudice to Article 33 of Regulation (EU) 2018/1725, eu-LISA shall take the necessary measures to ensure the security of the interoperability components and their related communication infrastructure. 3. In particular, eu-LISA shall adopt the necessary measures, including a security plan, a business continuity plan and a disaster recovery plan, in order to: (a) physically protect data, including by making contingency plans for the protection of critical infrastructure; (b) deny unauthorised persons access to data-processing equipment and installations; (c) prevent the unauthorised reading, copying, modification or removal of data media; (d) prevent the unauthorised input of data and the unauthorised inspection, modification or deletion of recorded personal data; (e) prevent the unauthorised processing of data and any unauthorised copying, modification or deletion of data; (f) prevent the use of automated data-processing systems by unauthorised persons using data communication equipment; (g) ensure that persons authorised to access the interoperability components have access only to the data covered by their access authorisation, by means of individual user identities and confidential access modes only; (h) ensure that it is possible to verify and establish to which bodies personal data may be transmitted using data communication equipment; (i) ensure that it is possible to verify and establish what data have been processed in the interoperability components, when, by whom and for what purpose; (j) prevent the unauthorised reading, copying, modification or deletion of personal data during the transmission of personal data to or from the interoperability components or during the transport of data media, in particular by means of appropriate encryption techniques; (k) ensure that, in the event of interruption, installed systems can be restored to normal operation; (l) ensure reliability by making sure that any faults in the functioning of the interoperability components are properly reported; (m) monitor the effectiveness of the security measures referred to in this paragraph and take the necessary organisational measures related to internal monitoring to ensure compliance with this Regulation and to assess those security measures in the light of new technological developments. 4. Member States, Europol and the ETIAS Central Unit shall take measures equivalent to those referred to in paragraph 3 as regards security in respect of the processing of personal data by the authorities having a right to access any of the interoperability components. Article 43 Security incidents 1. Any event that has or may have an impact on the security of the interoperability components and may cause damage to or loss of data stored in them shall be considered to be a security incident, in particular where unauthorised access to data may have occurred or where the availability, integrity and confidentiality of data has or may have been compromised. 2. Security incidents shall be managed so as to ensure a quick, effective and proper response. 3. Without prejudice to the notification and communication of a personal data breach pursuant to Article 33 of Regulation (EU) 2016/679, Article 30 of Directive (EU) 2016/680, or both, Member States shall notify the Commission, eu-LISA, the competent supervisory authorities and the European Data Protection Supervisor of any security incidents without delay. Without prejudice to Articles 34 and 35 of Regulation (EU) 2018/1725 and Article 34 of Regulation (EU) 2016/794, the ETIAS Central Unit and Europol shall notify the Commission, eu-LISA and the European Data Protection Supervisor of any security incidents without delay. In the event of a security incident in relation to the central infrastructure of the interoperability components, eu-LISA shall notify the Commission and the European Data Protection Supervisor without delay. 4. Information regarding a security incident that has or may have an impact on the operation of the interoperability components or on the availability, integrity and confidentiality of the data shall be provided to the Member States, the ETIAS Central Unit and Europol without delay and reported in compliance with the incident management plan to be provided by eu-LISA. 5. The Member States concerned, the ETIAS Central Unit, Europol and eu-LISA shall cooperate in the event of a security incident. The Commission shall lay down the specifications of this cooperation procedure by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2). Article 44 Self-monitoring Member States and the relevant Union agencies shall ensure that each authority entitled to access the interoperability components takes the measures necessary to monitor its compliance with this Regulation and cooperates, where necessary, with the supervisory authority. The data controllers referred to in Article 40 shall take the necessary measures to monitor the compliance of data processing pursuant to this Regulation, including through frequent verification of the logs referred to in Articles 10, 16, 24 and 36, and cooperate, where necessary, with the supervisory authorities and with the European Data Protection Supervisor. Article 45 Penalties Member States shall ensure that any misuse of data, processing of data or exchange of data contrary to this Regulation is punishable in accordance with national law. The penalties provided shall be effective, proportionate and dissuasive. Article 46 Liability 1. Without prejudice to the right to compensation from, and liability of the controller or processor under Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725: (a) any person or Member State that has suffered material or non-material damage as a result of an unlawful personal da processing operation or any other act incompatible with this Regulation by a Member State shall be entitled to receive compensation from that Member State; (b) any person or Member State that has suffered material or non-material damage as a result of any act by Europol, the European Border and Coast Guard Agency or eu-LISA incompatible with this Regulation shall be entitled to receive compensation from the agency in question. The Member State concerned, Europol, the European Border and Coast Guard Agency or eu-LISA shall be exempted from their liability under the first subparagraph, in whole or in part, if they prove that they are not responsible for the event which gave rise to the damage. 2. If any failure of a Member State to comply with its obligations under this Regulation causes damage to the interoperability components, that Member ate shall be liable for such damage, unless and insofar as eu-LISA or another Member State bound by this Regulation failed to take reasonable measures to prevent the damage from occurring or to minimise its impact. 3. Claims for compensation against a Member State for the damage referred to in paragraphs 1 and 2 shall be governed by the national law of the defendant Member State. Claims for compensation against the controller or eu-LISA for the damage referred to in paragraphs 1 and 2 shall be subject to the conditions provided for in the Treaties. Article 47 Right to information 1. The authority collecting the personal data to be stored in the shared BMS, the CIR or the MID shall provide the persons whose data are collected with the information required under Articles 13 and 14 of Regulation (EU) 2016/679, Articles 12 and 13 of Directive (EU) 2016/680 and Articles 15 and 16 of Regulation (EU) 2018/1725. The authority shall provide the information at the time that such data are collected. 2. All information shall be made available, using clear and plain language, in a linguistic version the person concerned understands or is reasonably expected to understand. This shall include providing information in a manner which is appropriate to the age of the data subjects who are minors. 3. Persons whose data are recorded in the EES, VIS or ETIAS shall be informed about the processing of personal data for the purposes of this Regulation in accordance with paragraph 1 when: (a) an individual file is created or updated in the EES in accordance with Article 14 of Regulation (EU) 2017/2226; (b) an application file is created or updated in VIS in accordance with Article 8 of Regulation (EC) No 767/2008; (c) an application file is created or updated in ETIAS in accordance with Article 19 of Regulation (EU) 2018/1240. Article 48 Right of access to, rectification and erasure of personal data stored in the MID and restriction of processing thereof 1. In order to exercise their rights under Articles 15 to 18 of Regulation (EU) 2016/679, Articles 17 to 20 of Regulation (EU) 2018/1725 and Articles 14, 15 and 16 of Directive (EU) 2016/680, any person shall have the right to address himself or herself to the competent authority of any Member State, which shall examine and reply to the request. 2. The Member State which examines such a request shall reply without undue delay and in any event within 45 days of receipt of the request. That period may be extended by 15 further days where necessary, taking into account the complexity and number of the requests. The Member State which examines the request shall inform the data subject of any such extension within 45 days of receipt of the request, together with the reasons for the delay. Member States may decide that replies are to be given by central offices. 3. If a request for rectification or erasure of personal data is made to a Member State other than the Member State responsible for the manual verification of different identities, the Member State to which the request has been made shall contact the authorities of the Member State responsible for the manual verification of different identities within seven days. The Member State responsible for the manual verification of different identities shall check the accuracy of the data and the lawfulness of the data processing without undue delay and in any event within 30 days of such contact. That period may be extended by 15 further days where necessary, taking into account the complexity and number of the requests. The Member State responsible for the manual verification of different identities shall inform the Member State which contacted it of any such extension together with the reasons for the delay. The person concerned shall be informed by the Member State which contacted the authority of the Member State responsible for the manual verification of different identities about the further procedure. 4. If a request for rectification or erasure of personal data is made to a Member State where the ETIAS Central Unit was responsible for the manual verification of different identities, the Member State to which the request has been made shall contact the ETIAS Central Unit within seven days to ask for its opinion. The ETIAS Central Unit shall give its opinion without undue delay and in any event within 30 days of being contacted. That period may be extended by 15 further days where necessary, taking into account the complexity and number of the requests. The person concerned shall be informed by the Member State which contacted the ETIAS Central Unit about the further procedure. 5. Where, following an examination, it is found that the data stored in the MID are inaccurate or have been recorded unlawfully, the Member State responsible for the manual verification of different identities or, where there was no Member State responsible for the manual verification of different identities or where the ETIAS Central Unit was responsible for the manual verification of different identities, the Member State to which the request has been made shall rectify or erase those data without any undue delay. The person concerned shall be informed in writing that his or her data have been rectified or erased. 6. Where data stored in the MID are amended by a Member State during their retention period, that Member State shall carry out the processing laid down in Article 27 and, where relevant, Article 29 to determine whether the amended data are to be linked. Where the processing does not report any match, that Member State shall erase the data from the identity confirmation file. Where the automated processing reports one or several matches, that Member State shall create or update the relevant link in accordance with the relevant provisions of this Regulation. 7. Where the Member State responsible for the manual verification of different identities or, where applicable, the Member State to which the request has been made does not agree that data stored in the MID are inaccurate or have been recorded unlawfully, that Member State shall adopt an administrative decision explaining in writing to the person concerned without delay why it is not prepared to rectify or erase data relating to him or her. 8. The decision referred to in paragraph 7 shall also provide the person concerned with information explaining the possibility to challenge the decision taken in respect of the request for access to, rectification, erasure or restriction of processing of personal data and, where relevant, information on how to bring an action or a complaint before the competent authorities or courts, and any assistance, including from the supervisory authorities. 9. Any request for access to, rectification, erasure or restriction of processing of personal data shall contain the necessary information to identify the person concerned. That information shall be used exclusively to enable the exercise of the rights referred to in this Article and shall be erased immediately afterwards. 10. The Member State responsible for the manual verification of different identities or, where applicable, the Member State to which the request has been made shall keep a written record that a request for access to, rectification, erasure or restriction of processing of personal data was made and how it was addressed, and shall make that record available to supervisory authorities without delay. 11. This Article is without prejudice to any limitations and restrictions to the rights set out in this Article pursuant to Regulation (EU) 2016/679 and Directive (EU) 2016/680. Article 49 Web portal 1. A web portal is established for the purpose of facilitating the exercise of the rights of access to, rectification, erasure or restriction of processing of personal data. 2. The web portal shall contain information on the rights and procedures referred to in Articles 47 and 48 and a user interface enabling persons whose data are processed in the MID and who have been informed of the presence of a red link in accordance with Article 32(4) to receive the contact information of the competent authority of the Member State responsible for the manual verification of different identities. 3. In order to obtain the contact information of the competent authority of the Member State responsible for the manual verification of different identities, the person whose data are processed in the MID should enter the reference to the authority responsible for the manual verification of different identities referred to in Article 34(d). The web portal shall use this reference in order to retrieve the contact information of the competent authority of the Member State responsible for the manual verification of different identities. The web portal shall also include a template e-mail to facilitate communication between the portal user and the competent authority of the Member State responsible for the manual verification of different identities. Such e-mail shall include a field for the single identification number referred to in Article 34(c) in order to allow the competent authority of the Member State responsible for the manual verification of different identities to identify the data concerned. 4. Member States shall provide eu-LISA with the contact details of all authorities that are competent to examine and reply to any request referred to in Articles 47 and 48 and shall regularly review whether those contact details are up to date. 5. eu-LISA shall develop the web portal and ensure its technical management. 6. The Commission shall adopt a delegated act in accordance with Article 73 laying down detailed rules on the operation of the web portal, including the user interface, the languages in which the web portal shall be available and the template e-mail. Article 50 Communication of personal data to third countries, international organisations and private parties Without prejudice to Article 65 of Regulation (EU) 2018/1240, Articles 25 and 26 of Regulation (EU) 2016/794, Article 41 of Regulation (EU) 2017/2226, Article 31 of Regulation (EC) No 767/2008, and the querying of Interpol databases through the ESP in accordance with Article 9(5) of this Regulation which comply with the provisions of Chapter V of Regulation (EU) 2018/1725 and Chapter V of Regulation (EU) 2016/679, personal data stored in, processed or accessed by the interoperability components shall not be transferred or made available to any third country, to any international organisation or to any private party. Article 51 Supervision by the supervisory authorities 1. Each Member State shall ensure that the supervisory authorities independently monitor the lawfulness of the processing of personal data under this Regulation by the Member State concerned, including their transmission to and from the interoperability components. 2. Each Member State shall ensure that the national laws, regulations and administrative provisions adopted pursuant to Directive (EU) 2016/680 are also applicable, where relevant, to access to the interoperability components by police authorities and designated authorities, including in relation to the rights of the persons whose data are so accessed. 3. The supervisory authorities shall ensure that an audit of the personal data processing operations by the responsible national authorities for the purposes of this Regulation is carried out in accordance with relevant international auditing standards at least every four years. The supervisory authorities shall publish annually the number of requests for rectification, erasure or restriction of processing of personal data, the action subsequently taken and the number of rectifications, erasures and restrictions of processing made in response to requests by the persons concerned. 4. Member States shall ensure that their supervisory authorities have sufficient resources and expertise to fulfil the tasks entrusted to them under this Regulation. 5. Member States shall supply any information requested by a supervisory authority referred to in Article 51(1) of Regulation (EU) 2016/679 and shall, in particular, provide it with information on the activities carried out in accordance with their responsibilities under this Regulation. Member States shall grant the supervisory authorities referred to in Article 51(1) of Regulation (EU) 2016/679 access to their logs referred to in Articles 10, 16, 24 and 36 of this Regulation, to the justifications referred to in Article 22(2) of this Regulation and allow them to access all their premises used for interoperability purposes at all times. Article 52 Audits by the European Data Protection Supervisor The European Data Protection Supervisor shall ensure that an audit of personal data processing operations by eu-LISA, the ETIAS Central Unit and Europol for the purposes of this Regulation is carried out in accordance with relevant international auditing standards at least every four years. A report of that audit shall be sent to the European Parliament, to the Council, to eu-LISA, to the Commission, to the Member States and to the Union agency concerned. eu-LISA, the ETIAS Central Unit and Europol shall be given an opportunity to make comments before the reports are adopted. eu-LISA, the ETIAS Central Unit and Europol shall supply information requested by the European Data Protection Supervisor to it, grant the European Data Protection Supervisor access to all the documents it requests and to their logs referred to in Articles 10, 16, 24 and 36 and allow the European Data Protection Supervisor access to all their premises at any time. Article 53 Cooperation between supervisory authorities and the European Data Protection Supervisor 1. The supervisory authorities and the European Data Protection Supervisor shall, each acting within the scope of their respective competences, cooperate actively within the framework of their respective responsibilities and ensure coordinated supervision of the use of the interoperability components and the application of other provisions of this Regulation, in particular if the European Data Protection Supervisor or a supervisory authority finds major discrepancies between practices of Member States or finds potentially unlawful transfers using the communication channels of the interoperability components. 2. In the cases referred to in paragraph 1 of this Article, coordinated supervision shall be ensured in accordance with Article 62 of Regulation (EU) 2018/1725. 3. The European Data Protection Board shall send a joint report of its activities under this Article to the European Parliament, to the Council, to the Commission, to Europol, to the European Border and Coast Guard Agency and to eu-LISA by 12 June 2021 and every two years thereafter. That report shall include a chapter on each Member State prepared by the supervisory authority of the Member State concerned. CHAPTER VIII Responsibilities Article 54 Responsibilities of eu-LISA during the design and development phase 1. eu-LISA shall ensure that the central infrastructures of the interoperability components are operated in accordance with this Regulation. 2. The interoperability components shall be hosted by eu-LISA in its technical sites and shall provide the functionalities laid down in this Regulation in accordance with the conditions of security, availability, quality and performance referred to in Article 55(1). 3. eu-LISA shall be responsible for the development of the interoperability components and for any adaptations required for establishing interoperability between the central systems of the EES, VIS, ETIAS, SIS, Eurodac, ECRIS-TCN, and the ESP, the shared BMS, the CIR, the MID and the CRRS. Without prejudice to Article 66, eu-LISA shall not have access to any of the personal data processed through the ESP, the shared BMS, the CIR or the MID. eu-LISA shall define the design of the physical architecture of the interoperability components including their communication infrastructures and the technical specifications and their evolution as regards the central infrastructure and the secure communication infrastructure, which shall be adopted by the Management Board, subject to a favourable opinion of the Commission. eu-LISA shall also implement any necessary adaptations to the EES, VIS, ETIAS or SIS deriving from the establishment of interoperability and provided for by this Regulation. eu-LISA shall develop and implement the interoperability components as soon as possible after the entry into force of this Regulation and the adoption by the Commission of the measures provided for in Articles 8(2), 9(7), 28(5) and (7), 37(4), 38(3), 39(5), 43(5) and 78(10). The development shall consist of the elaboration and implementation of the technical specifications, testing and overall project management and coordination. 4. During the design and development phase, a Programme Management Board composed of a maximum of 10 members shall be established. It shall be composed of seven members appointed by eu-LISA's Management Board from among its members or its alternates, the chair of the Interoperability Advisory Group referred to in Article 75, a member representing eu-LISA appointed by its Executive Director, and one member appointed by the Commission. The members appointed by eu-LISA's Management Board shall be elected only from those Member States that are fully bound under Union law by the legal instruments governing the development, establishment, operation and use of all the EU information systems and which will participate in the interoperability components. 5. The Programme Management Board shall meet regularly and at least three times per quarter. It shall ensure the adequate management of the design and development phase of the interoperability components. Every month, the Programme Management Board shall submit written reports on progress of the project to eu-LISA's Management Board. The Programme Management Board shall have no decision-making power, nor any mandate to represent the members of eu-LISA's Management Board. 6. eu-LISA's Management Board shall establish the rules of procedure of the Programme Management Board, which shall include in particular rules on: (a) chairmanship; (b) meeting venues; (c) preparation of meetings; (d) admission of experts to the meetings; (e) communication plans ensuring that non-participating Members of the Management Board are kept fully informed. The chairmanship shall be held by a Member State that is fully bound under Union law by the legal instruments governing the development, establishment, operation and use of all the EU information systems and which will participate in the interoperability components. All travel and subsistence expenses incurred by the members of the Programme Management Board shall be paid by eu-LISA, and Article 10 of the eu-LISA Rules of Procedure shall apply mutatis mutandis. eu-LISA shall provide the Programme Management Board with a secretariat. The Interoperability Advisory Group referred to in Article 75 shall meet regularly until the start of operations of the interoperability components. It shall report after each meeting to the Programme Management Board. It shall provide the technical expertise to support the tasks of the Programme Management Board and shall follow up on the state of preparation of the Member States. Article 55 Responsibilities of eu-LISA following the entry into operations 1. Following the entry into operations of each interoperability component, eu-LISA shall be responsible for the technical management of the central infrastructure of the interoperability components, including their maintenance and technological developments. In cooperation with the Member States, it shall ensure that the best available technology is used, subject to a cost-benefit analysis. eu-LISA shall also be responsible for the technical management of the communication infrastructure referred to in Articles 6, 12, 17, 25 and 39. Technical management of the interoperability components shall consist of all the tasks and technical solutions necessary to keep the interoperability components functioning and providing uninterrupted services to the Member States and to the Union agencies 24 hours a day, 7 days a week in accordance with this Regulation. It shall include the maintenance work and technical developments necessary to ensure that the components function at a satisfactory level of technical quality, in particular as regards the response time for interrogation of the central infrastructures in accordance with the technical specifications. All interoperability components shall be developed and managed in such a way as to ensure fast, seamless, efficient and controlled access, full, uninterrupted availability of the components and of the data stored in the MID, the shared BMS and the CIR, and a response time in line with the operational needs of the Member States' authorities and Union agencies. 2. Without prejudice to Article 17 of the Staff Regulations of Officials of the European Union, eu-LISA shall apply appropriate rules of professional secrecy or other equivalent duties of confidentiality to its staff required to work with data stored in the interoperability components. This obligation shall also apply after such staff leave office or employment or after the termination of their activities. Without prejudice to Article 66, eu-LISA shall not have access to any of the personal data processed through the ESP, the shared BMS, the CIR and the MID. 3. eu-LISA shall develop and maintain a mechanism and procedures for carrying out quality checks on the data stored in the shared BMS and the CIR in accordance with Article 37. 4. eu-LISA shall also perform tasks related to providing training on the technical use of the interoperability components. Article 56 Responsibilities of Member States 1. Each Member State shall be responsible for: (a) the connection to the communication infrastructure of the ESP and the CIR; (b) the integration of the existing national systems and infrastructures with the ESP, the CIR and the MID; (c) the organisation, management, operation and maintenance of its existing national infrastructure and of its connection to the interoperability components; (d) the management of, and arrangements for, access by the duly authorised staff of the competent national authorities to the ESP, the CIR and the MID in accordance with this Regulation and the creation and regular update of a list of those staff and their profiles; (e) the adoption of the legislative measures referred to in Article 20(5) and (6) in order to access the CIR for identification purposes; (f) the manual verification of different identities referred to in Article 29; (g) compliance with the data quality requirements established under Union law; (h) compliance with the rules of each EU information system regarding the security and integrity of personal data; (i) remedying any deficiencies identified in the Commission's evaluation report concerning data quality referred to in Article 37(5). 2. Each Member State shall connect their designated authorities to the CIR. Article 57 Responsibilities of the ETIAS Central Unit The ETIAS Central Unit shall be responsible for: (a) the manual verification of different identities in accordance with Article 29; (b) carrying out multiple-identity detection between the data stored in the EES, VIS, Eurodac and SIS, as referred to in Article 69. CHAPTER IX Amendments to other Union instruments Article 58 Amendments to Regulation (EC) No 767/2008 Regulation (EC) No 767/2008 is amended as follows: (1) in Article 1, the following paragraph is added: \u2018By storing identity data, travel document data and biometric data in the common identity repository (CIR) established by Article 17(1) of Regulation (EU) 2019/817 of the European Parliament and of the Council (*1), the VIS contributes to facilitating and assisting in the correct identification of persons registered in the VIS under the conditions and for the purposes of Article 20 of that Regulation. (*1) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).\u2019;\" (2) in Article 4, the following points are added: \u2018(12) \u2018VIS data\u2019 means all data stored in the VIS Central System and in the CIR in accordance with Articles 9 to 14; (13) \u2018identity data\u2019 means the data referred to in Article 9(4)(a) and (aa); (14) \u2018fingerprint data\u2019 means the data relating to the five fingerprints of the index, middle finger, ring finger, little finger and the thumb from the right hand and, where present, from the left hand;\u2019; (3) in Article 5, the following paragraph is inserted: \u20181a. The CIR shall contain the data referred to in Article 9(4)(a) to (c), (5) and (6). The remaining VIS data shall be stored in the VIS Central System.\u2019; (4) in Article 6 paragraph 2 is replaced by the following: \u20182. Access to the VIS for the purposes of consulting the data shall be reserved exclusively for the duly authorised staff of the national authorities of each Member State which are competent for the purposes laid down in Articles 15 to 22, and for the duly authorised staff of the national authorities of each Member State and of the Union agencies which are competent for the purposes laid down in Articles 20 and 21 of Regulation (EU) 2019/817. Such access shall be limited according to the extent that the data are required for the performance of their tasks for those purposes, and proportionate to the objectives pursued.\u2019; (5) in point (4) of Article 9, points (a) to (c) are replaced by the following: \u2018(a) surname (family name); first name or names (given names); date of birth; sex; (aa) surname at birth (former surname(s)); place and country of birth; current nationality and nationality at birth; (b) the type and number of the travel document or documents and the three-letter code of the issuing country of the travel document or documents; (c) the date of expiry of the validity of the travel document or documents; (ca) the authority which issued the travel document and its date of issue;\u2019. Article 59 Amendments to Regulation (EU) 2016/399 In Article 8 the following paragraph is inserted: \u20184a. Where on entry or exit, consultation of the relevant databases including the multiple-identity detector through the European search portal established by Article 25(1) and Article 6(1) of Regulation (EU) 2019/817 of the European Parliament and of the Council (*2) respectively results in a yellow link or detects a red link, the border guard shall consult the common identity repository established by Article 17(1) of that Regulation or SIS or both to assess the differences in the linked identity data or travel document data. The border guard shall carry out any additional verification necessary to take a decision on the status and colour of the link. In accordance with Article 69(1) of Regulation (EU) 2019/817, this paragraph shall apply as from the start of operations of the multiple-identity detector under Article 72(4) of that Regulation. Article 60 Amendments to Regulation (EU) 2017/2226 Regulation (EU) 2017/2226 is amended as follows: (1) in Article 1, the following paragraph is added: \u20183. By storing identity data, travel document data and biometric data in the common identity repository (CIR) established by Article 17(1) of Regulation (EU) 2019/817 of the European Parliament and of the Council (*3), the EES contributes to facilitating and assisting in the correct identification of persons registered in the EES under the conditions and for the purposes of Article 20 of that Regulation. (*3) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).\u2019;\" (2) in Article 3, paragraph 1 is amended as follows: (a) point (22) is replaced by the following: \u2018(22) \u2018EES data\u2019 means all data stored in the EES Central System and in the CIR in accordance with Articles 15 to 20;\u2019; (b) the following point is inserted: \u2018(22a) \u2018identity data\u2019 means the data referred to in point (a) of Article 16(1) as well as the relevant data referred to in Articles 17(1) and 18(1);\u2019; (c) the following points are added: \u2018(32) \u2018ESP\u2019 means the European search portal established by Article 6(1) of Regulation (EU) 2019/817; (33) \u2018CIR\u2019 means the common identity repository established by Article 17(1) of Regulation (EU) 2019/817.\u2019; (3) in Article 6(1), the following point is added: \u2018(j) ensure the correct identification of persons.\u2019; (4) Article 7 is amended as follows: (a) paragraph 1 is amended as follows: (i) the following point is inserted: \u2018(aa) the CIR central infrastructure as referred to in point (a) of Article 17(2) of Regulation (EU) 2019/817;\u2019; (ii) point (f) is replaced by the following: \u2018(f) a secure communication infrastructure between the EES Central System and the central infrastructures of the ESP and the CIR.\u2019; (b) the following paragraph is inserted: \u20181a. The CIR shall contain the data referred to in points (a) to (d) of Article 16(1), points (a), (b) and (c) of Article 17(1) and Article 18(1) and (2). The remaining EES data shall be stored in the EES Central System.\u2019; (5) in Article 9, the following paragraph is added: \u20184. Access to the EES data stored in the CIR shall be reserved exclusively for the duly authorised staff of the national authorities of each Member State and for the duly authorised staff of the Union agencies that are competent for the purposes laid down in Article 20 and Article 21 of Regulation (EU) 2019/817. Such access shall be limited according to the extent that the data are required for the performance of their tasks for those purposes, and proportionate to the objectives pursued.\u2019; (6) Article 21 is amended as follows: (a) paragraph 1 is replaced by the following: \u20181. Where it is technically impossible to enter data in the EES Central System or the CIR or in the event of a failure of the EES Central System or the CIR, the data referred to in Articles 16 to 20 shall be temporarily stored in the NUI. Where that is not possible, the data shall be temporarily stored locally in an electronic format. In both cases, the data shall be entered in the EES Central System or the CIR as soon as the technical impossibility or failure has been remedied. The Member States shall take the appropriate measures and deploy the required infrastructure, equipment and resources to ensure that such temporary local storage may be carried out at any time and for any of their border crossing points.\u2019; (b) in paragraph 2, the first subparagraph is replaced by the following: \u20182. Without prejudice to the obligation to carry out border checks under Regulation (EU) 2016/399, the border authority, in the exceptional situation where it is technically impossible to enter data in either the EES Central System and the CIR or in the NUI and it is technically impossible to temporarily store the data locally in an electronic format, shall manually store the data referred to in Articles 16 to 20 of this Regulation, with the exception of biometric data, and shall affix an entry or exit stamp in the travel document of the third-country national. That data shall be entered in the EES Central System and the CIR as soon as technically possible.\u2019; (7) Article 23 is amended as follows: (a) the following paragraph is inserted: \u20182a. For the purpose of the verifications in accordance with paragraph 1 of this Article, the border authority shall launch a query by using the ESP to compare the data on the third-country national with the relevant data in the EES and the VIS.\u2019; (b) in paragraph 4, the first subparagraph is replaced by the following: \u20184. Where the search with the alphanumeric data set out in paragraph 2 of this Article indicates that data on the third-country national are not recorded in the EES, where a verification of the third-country national pursuant to paragraph 2 of this Article fails or where there are doubts as to the identity of the third-country national, the border authorities shall have access to data for identification in accordance with Article 27 in order to create or update an individual file in accordance with Article 14.\u2019; (8) in Article 32 the following paragraph is inserted: \u20181a. In cases where the designated authorities have launched a query of the CIR in accordance with Article 22 of Regulation (EU) 2019/817, they may access the EES for consultation where the conditions laid down in this Article are met and where the reply received as referred to in Article 22(2) of Regulation (EU) 2019/817 reveals that data are stored in the EES.\u2019; (9) in Article 33 the following paragraph is inserted: \u20181a. In cases where Europol has launched a query of the CIR in accordance with Article 22 of Regulation (EU) 2019/817, it may access the EES for consultation where the conditions laid down in this Article are met and where the reply received as referred to in Article 22(2) of Regulation (EU) 2019/817 reveals that data are stored in the EES.\u2019; (10) Article 34 is amended as follows: (a) in paragraphs 1 and 2, the words \u2018in the EES Central System\u2019 are replaced by the words \u2018in the CIR and in the EES Central System\u2019; (b) in paragraph 5, the words \u2018from the EES Central System\u2019 are replaced by the words \u2018from the EES Central System and from the CIR\u2019; (11) in Article 35, paragraph 7 is replaced by the following: \u20187. The EES Central System and the CIR shall immediately inform all Member States of the erasure of EES or CIR data and where applicable remove them from the list of identified persons referred to in Article 12(3).\u2019; (12) in Article 36, the words \u2018of the EES Central System\u2019 shall be replaced by the words \u2018of the EES Central System and the CIR\u2019; (13) Article 37 is amended as follows: (a) the first subparagraph of paragraph 1 is replaced by the following: \u20181. eu-LISA shall be responsible for the development of the EES Central System and the CIR, the NUIs, the Communication Infrastructure and the Secure Communication Channel between the EES Central System and the VIS Central System. eu-LISA shall also be responsible for the development of the web service referred to in Article 13 in accordance with the detailed rules referred to in Article 13(7) and the specifications and conditions adopted pursuant to point (h) of the first paragraph of Article 36 and for the development of the data repository referred to in Article 63(2).\u2019; (b) the first subparagraph of paragraph 3 is replaced by the following: \u20183. eu-LISA shall be responsible for the operational management of the EES Central System and the CIR, the NUIs and the Secure Communication Channel between the EES Central System and the VIS Central System. It shall ensure, in cooperation with the Member States, that at all times the best available technology, subject to a cost-benefit analysis, is used for the EES Central System and the CIR, the NUIs, the Communication Infrastructure, the Secure Communication Channel between the EES Central System and the VIS Central System, the web service referred to in Article 13 and the data repository referred to in Article 63(2). eu-LISA shall also be responsible for the operational management of the Communication Infrastructure between the EES Central System and the NUIs, for the web service referred to in Article 13 and the data repository referred to in Article 63(2).\u2019; (14) in Article 46(1) the following point is added: \u2018(f) a reference to the use of the ESP to query the EES as referred to in Article 7(2) of Regulation (EU) 2019/817.\u2019; (15) Article 63 is amended as follows: (a) paragraph 2 is replaced by the following: \u20182. For the purpose of paragraph 1 of this Article, eu-LISA shall store the data referred to in that paragraph in the central repository for reporting and statistics referred to in Article 39 of the Regulation (EU) 2019/817.\u2019; (b) in paragraph 4 the following subparagraph is added: \u2018The daily statistics shall be stored in the central repository for reporting and statistics.\u2019. Article 61 Amendments to Regulation (EU) 2018/1240 Regulation (EU) 2018/1240 is amended as follows: (1) in Article 1, the following paragraph is added: \u20183. By storing identity data and travel document data in the common identity repository (CIR) established by Article 17(1) of Regulation (EU) 2019/817 of the European Parliament and of the Council (*4), ETIAS contributes to facilitating and assisting in the correct identification of persons registered in ETIAS under the conditions and for the purposes of Article 20 of that Regulation. (*4) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).\u2019;\" (2) in Article 3(1), the following points are added: \u2018(23) \u2018CIR\u2019 means the common identity repository established by Article 17(1) of Regulation (EU) 2019/817; (24) \u2018ESP\u2019 means the European search portal established by Article 6(1) of Regulation (EU) 2019/817; (25) \u2018ETIAS Central System\u2019 means the Central System referred to in point (a) of Article 6(2) together with the CIR to the extent that the CIR contains the data referred to in Article 6(2a); (26) \u2018identity data\u2019 means the data referred to in points (a), (b) and (c) of Article 17(2); (27) \u2018travel document data\u2019 means the data referred to in points (d) and (e) of Article 17(2) and the three letter code of the country issuing the travel document as referred to in point (c) of Article 19(3).\u2019; (3) in Article 4, the following point is added: \u2018(g) contribute to the correct identification of persons.\u2019; (4) Article 6 is amended as follows: (a) paragraph 2 is amended as follows: (i) point (a) is replaced by the following: \u2018(a) a Central System, including the ETIAS watchlist referred to in Article 34;\u2019; (ii) the following point is inserted: \u2018(aa) the CIR;\u2019; (iii) point (d) is replaced by the following: \u2018(d) a secure communication infrastructure between the Central System and the central infrastructures of the ESP and the CIR;\u2019; (b) the following paragraph is inserted: \u20182a. The CIR shall contain the identity data and travel document data. The remaining data shall be stored in the Central System.\u2019; (5) Article 13 is amended as follows: (a) the following paragraph is inserted: \u20184a. Access to the ETIAS identity data and travel document data stored in the CIR shall also be reserved exclusively for the duly authorised staff of the national authorities of each Member State and for the duly authorised staff of the Union agencies that are competent for the purposes laid down in Article 20 and Article 21 of Regulation (EU) 2019/817. Such access shall be limited according to the extent that the data are required for the performance of their tasks for those purposes, and proportionate to the objectives pursued.\u2019; (b) paragraph 5 is replaced by the following: \u20185. Each Member State shall designate the competent national authorities referred to in paragraphs 1, 2, 4 and 4a of this Article and shall communicate a list of these authorities to eu-LISA without delay, in accordance with Article 87(2). That list shall specify for which purpose the duly authorised staff of each authority shall have access to the data in ETIAS Information System in accordance with paragraphs 1, 2, 4 and 4a of this Article.\u2019; (6) in Article 17, paragraph 2 is amended as follows: (a) point (a) is replaced by the following: \u2018(a) surname (family name), first name(s) (given name(s)), surname at birth; date of birth, place of birth, sex, current nationality;\u2019; (b) the following point is inserted: \u2018(aa) country of birth, first name(s) of the parents of the applicant;\u2019; (7) in Article 19(4) the words \u2018point (a) of Article 17(2)\u2019 are replaced by the words \u2018points (a) and (aa) of Article 17(2)\u2019; (8) Article 20 is amended as follows: (a) in paragraph 2, the first subparagraph is replaced by the following: \u20182. The ETIAS Central System shall launch a query by using the ESP to compare the relevant data referred to in points (a), (aa), (b), (c), (d), (f), (g), (j), (k) and (m) of Article 17(2) and in Article 17(8) to the data present in a record, file or alert registered in an application file stored in the ETIAS Central System, SIS, the EES, VIS, Eurodac, Europol data and in the Interpol SLTD and TDAWN databases.\u2019; (b) in paragraph 4, the words \u2018points (a), (b), (c), (d), (f), (g), (j), (k) and (m) of Article 17(2)\u2019 are replaced by the words \u2018points (a), (aa), (b), (c), (d), (f), (g), (j), (k) and (m) of Article 17(2)\u2019; (c) in paragraph 5, the words \u2018points (a), (c), (f), (h) and (i) of Article 17(2)\u2019 are replaced by the words \u2018points (a), (aa), (c), (f), (h) and (i) of Article 17(2)\u2019; (9) in Article 23, paragraph 1 is replaced by the following: \u20181. The ETIAS Central System shall launch a query by using the ESP to compare the relevant data referred to in points (a), (aa), (b) and (d) of Article 17(2) to the data present in SIS in order to determine whether the applicant is the subject of one of the following alerts: (a) an alert on missing persons; (b) an alert on persons sought to assist with a judicial procedure; (c) an alert on persons for discreet checks or specific checks.\u2019; (10) in Article 52, the following paragraph is inserted: \u20181a. In cases where the designated authorities have launched a query of the CIR in accordance with Article 22 of Regulation (EU) 2019/817, they may access the application files stored in the ETIAS Central System in accordance with this Article for consultation where the reply received as referred to in Article 22(2) of Regulation (EU) 2019/817 reveals that data are stored in the application files stored in the ETIAS Central System.\u2019; (11) in Article 53, the following paragraph is inserted: \u20181a. In cases where Europol has launched a query of the CIR in accordance with Article 22 of Regulation (EU) 2019/817, it may access the application files stored in the ETIAS Central System in accordance with this Article for consultation where the reply received as referred to in Article 22(2) of Regulation (EU) 2019/817 reveals that data are stored in the application files stored in the ETIAS Central System.\u2019; (12) in the fifth subparagraph of Article 65(3), the words \u2018points (a), (b), (d), (e) and (f) of Article 17(2)\u2019 are replaced by the words \u2018points (a), (aa), (b), (d), (e) and (f) of Article 17(2)\u2019; (13) in Article 69(1), the following point is inserted: \u2018(ca) where relevant, a reference to the use of the ESP to query the ETIAS Central System as referred to in Article 7(2) of Regulation (EU) 2019/817\u2019; (14) in Article 73(2), the words \u2018the central repository of data\u2019 are replaced by the words \u2018the central repository for reporting and statistics referred to in Article 39 of Regulation (EU) 2019/817, insofar as it contains data obtained from the ETIAS Central System under Article 84 of this Regulation\u2019; (15) in Article 74(1), the first subparagraph is replaced by the following: \u20181. Following the entry into operations of ETIAS, eu-LISA shall be responsible for the technical management of the ETIAS Central System and the NUIs. It shall also be responsible for any technical testing required for the establishment and update of the ETIAS screening rules. It shall ensure, in cooperation with the Member States that, at all times, the best available technology is used, subject to a cost-benefit analysis. eu-LISA shall also be responsible for the technical management of the communication infrastructure between the ETIAS Central System and the NUIs as well as for the public website, the app for mobile devices, the email service, the secure account service, the verification tool for applicants, the consent tool for applicants, the assessment tool for the ETIAS watchlist, the carrier gateway, the web service and the software to process the applications.\u2019; (16) in Article 84(2), the first subparagraph is replaced by the following: \u20182. For the purpose of paragraph 1 of this Article, eu-LISA shall store the data referred to in that paragraph in the central repository for reporting and statistics referred to in Article 39 of Regulation (EU) 2019/817. In accordance with Article 39(1) of that Regulation, cross-system statistical data and analytical reporting shall allow the authorities listed in paragraph 1 of this Article to obtain customisable reports and statistics, to support the implementation of the ETIAS screening rules referred to in Article 33, to improve the assessment of the security, illegal immigration and high epidemic risks, to enhance the efficiency of border checks and to help the ETIAS Central Unit and the ETIAS National Units process travel authorisation applications.\u2019; (17) in Article 84(4), the following subparagraph is added: \u2018The daily statistics shall be stored in the central repository for reporting and statistics referred to in Article 39 of Regulation (EU) 2019/817.\u2019. Article 62 Amendments to Regulation (EU) 2018/1726 Regulation (EU) 2018/1726 is amended as follows: (1) Article 12 is replaced by the following: \u2018Article 12 Data quality 1. Without prejudice to Member States' responsibilities with regard to the data entered into the systems under the Agency's operational responsibility, the Agency, closely involving its Advisory Groups, shall establish for all systems under the Agency's operational responsibility automated data quality control mechanisms and procedures, common data quality indicators and the minimum quality standards to store data, in accordance with the relevant provisions of the legal instruments governing those information systems and of Article 37 of Regulations (EU) 2019/817 (*5) and (EU) 2019/818 (*6) of the European Parliament and of the Council. 2. The Agency shall establish a central repository containing only anonymised data for reporting and statistics in accordance with Article 39 of Regulations (EU) 2019/817 and (EU) 2019/818, subject to specific provisions in the legal instruments governing the development, establishment, operation and use of large-scale IT systems managed by the Agency. (*5) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).\" (*6) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ L 135, 22.5.2019, p. 85).\u2019;\" (2) in Article 19, paragraph 1 is amended as follows: (a) the following point is inserted: \u2018(eea) adopt reports on the state of play of the development of the interoperability components pursuant to Article 78(2) of Regulation (EU) 2019/817 and Article 74(2) of Regulation (EU) 2019/818;\u2019; (b) point (ff) is replaced by the following: \u2018(ff) adopt reports on the technical functioning of SIS pursuant to Article 60(7) of Regulation (EU) 2018/1861 of the European Parliament and of the Council (*7) and Article 74(8) of Regulation (EU) 2018/1862 of the European Parliament and of the Council (*8), of the VIS pursuant to Article 50(3) of Regulation (EC) No 767/2008 and Article 17(3) of Decision 2008/633/JHA, of EES pursuant to Article 72(4) of Regulation (EU) 2017/2226, of ETIAS pursuant to Article 92(4) of Regulation (EU) 2018/1240, of ECRIS-TCN and of the ECRIS reference implementation pursuant to Article 36(8) of Regulation (EU) 2019/816 of the European Parliament and of the Council (*9) and of the interoperability components pursuant to Article 78(3) of Regulation (EU) 2019/817 and Article 74(3) of Regulation (EU) 2019/818; (*7) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, p. 14).\" (*8) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).\" (*9) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).\u2019;\" (c) point (hh) is replaced by the following: \u2018(hh) adopt formal comments on the European Data Protection Supervisor's reports on its audits pursuant to Article 56(2) of Regulation (EU) 2018/1861, Article 42(2) of Regulation (EC) No 767/2008, Article 31(2) of Regulation (EU) No 603/2013, Article 56(2) of Regulation (EU) 2017/2226, Article 67 of Regulation (EU) 2018/1240, Article 29(2) of Regulation (EU) 2019/816 and Article 52 of Regulations (EU) 2019/817 and (EU) 2019/818 and ensure appropriate follow up of those audits;\u2019; (d) point (mm) is replaced by the following: \u2018(mm) ensure annual publication of the list of competent authorities authorised to search directly the data contained in SIS pursuant to Article 41(8) of Regulation (EU) 2018/1861 and Article 56(7) of Regulation (EU) 2018/1862, together with the list of Offices of the national systems of SIS (N.SIS) and SIRENE Bureaux pursuant to Article 7(3) of Regulation (EU) 2018/1861 and Article 7(3) of Regulation (EU) 2018/1862 respectively as well as the list of competent authorities pursuant to Article 65(2) of Regulation (EU) 2017/2226, the list of competent authorities pursuant to Article 87(2) of Regulation (EU) 2018/1240, the list of central authorities pursuant to Article 34(2) of Regulation (EU) 2019/816 and the list of authorities pursuant to Article 71(1) of Regulation (EU) 2019/817 and Article 67(1) of Regulation (EU) 2019/818;\u2019; (3) in Article 22, paragraph 4 is replaced by the following: \u20184. Europol and Eurojust may attend the meetings of the Management Board as observers when a question concerning SIS II, in relation to the application of Decision 2007/533/JHA is on the agenda. The European Border and Coast Guard Agency may attend the meetings of the Management Board as an observer when a question concerning SIS in relation to the application of Regulation (EU) 2016/1624 is on the agenda. Europol may attend the meetings of the Management Board as an observer when a question concerning VIS, in relation to the application of Decision 2008/633/JHA or a question concerning Eurodac, in relation to the application of Regulation (EU) No 603/2013 is on the agenda. Europol may attend the meetings of the Management Board as an observer when a question concerning EES in relation to the application of Regulation (EU) 2017/2226 is on the agenda or when a question concerning ETIAS in relation to Regulation (EU) 2018/1240 is on the agenda. The European Border and Coast Guard Agency may attend the meetings of the Management Board as an observer when a question concerning ETIAS in relation with the application of Regulation (EU) 2018/1240 is on the agenda. Eurojust, Europol and the European Public Prosecutor's Office may attend the meetings of the Management Board as observers when a question concerning Regulation (EU) 2019/816 is on the agenda. Europol, Eurojust and the European Border and Coast Guard Agency may attend the meetings of the Management Board as observers when a question concerning Regulations (EU) 2019/817 and (EU) 2019/818 is on the agenda. The Management Board may invite any other person whose opinion may be of interest to attend its meetings as an observer.\u2019; (4) in Article 24(3), point (p) is replaced by the following: \u2018(p) without prejudice to Article 17 of the Staff Regulations of Officials, establishing confidentiality requirements in order to comply with Article 17 of Regulation (EC) No 1987/2006, Article 17 of Decision 2007/533/JHA, Article 26(9) of Regulation (EC) No 767/2008, Article 4(4) of Regulation (EU) No 603/2013, Article 37(4) of Regulation (EU) 2017/2226, Article 74(2) of Regulation (EU) 2018/1240, Article 11(16) of Regulation (EU) 2019/816 and Article 55(2) of Regulations (EU) 2019/817 and (EU) 2019/818;\u2019; (5) Article 27 is amended as follows: (a) in paragraph 1, the following point is inserted: \u2018(da) Interoperability Advisory Group;\u2019; (b) paragraph 3 is replaced by the following: \u20183. Europol, Eurojust and the European Border and Coast Guard Agency may each appoint a representative to the SIS II Advisory Group. Europol may also appoint a representative to the VIS and Eurodac and EES-ETIAS Advisory Groups. The European Border and Coast Guard Agency may also appoint a representative to the EES-ETIAS Advisory Group. Eurojust, Europol, and the European Public Prosecutors Office may each appoint a representative to the ECRIS-TCN Advisory Group. Europol, Eurojust and the European Border and Coast Guard Agency may each appoint a representative to the Interoperability Advisory Group.\u2019. Article 63 Amendments to Regulation (EU) 2018/1861 Regulation (EU) 2018/1861 is amended as follows: (1) in Article 3, the following points are added: \u2018(22) \u2018ESP\u2019 means the European search portal established by Article 6(1) of Regulation (EU) 2019/817 of the European Parliament and of the Council (*10); (23) \u2018shared BMS\u2019 means the shared biometric matching service established by Article 12(1) of Regulation (EU) 2019/817; (24) \u2018CIR\u2019 means the common identity repository established by Article 17(1) of Regulation (EU) 2019/817; (25) \u2018MID\u2019 means the multiple-identity detector established by Article 25(1) of Regulation (EU) 2019/817. (*10) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).\u2019;\" (2) Article 4 is amended as follows: (a) in paragraph 1, points (b) and (c) are replaced by the following: \u2018(b) a national system (N.SIS) in each of the Member States, consisting of the national data systems which communicate with Central SIS, including at least one national or shared backup N.SIS; (c) a communication infrastructure between CS-SIS, backup CS-SIS and NI-SIS (\u2018the Communication Infrastructure\u2019) that provides an encrypted virtual network dedicated to SIS data and the exchange of data between SIRENE Bureaux, as referred to in Article 7(2); and (d) a secure communication infrastructure between CS-SIS and the central infrastructures of the ESP, the shared BMS and the MID.\u2019; (b) the following paragraphs are added: \u20188. Without prejudice to paragraphs 1 to 5, SIS data may also be searched via the ESP. 9. Without prejudice to paragraphs 1 to 5, SIS data may also be transmitted via the secure communication infrastructure referred to in point (d) of paragraph 1. These transmissions shall be limited to the extent that the data are required for the purposes of Regulation (EU) 2019/817.\u2019; (3) in Article 7, the following paragraph is inserted: \u20182a. The SIRENE Bureaux shall also ensure the manual verification of different identities in accordance with Article 29 Regulation (EU) 2019/817. To the extent necessary to carry out this task, the SIRENE Bureaux shall have access to the data stored in the CIR and the MID for the purposes laid down in Articles 21 and 26 of Regulation (EU) 2019/817.\u2019; (4) in Article 12, paragraph 1 is replaced by the following: \u20181. Member States shall ensure that every access to and all exchanges of personal data within CS-SIS are logged in their N.SIS for the purposes of checking whether the search was lawful, monitoring the lawfulness of data processing, self-monitoring, ensuring the proper functioning of N.SIS, as well as for data integrity and security. This requirement does not apply to the automatic processes referred to in points (a), (b) and (c) of Article 4(6). Member States shall ensure that every access to personal data via the ESP is also logged for the purposes of checking whether the search was lawful, monitoring the lawfulness of data processing, self-monitoring, and data integrity and security.\u2019; (5) in Article 34(1), the following point is added: \u2018(g) verifying different identities and combating identity fraud in accordance with Chapter V of Regulation (EU) 2019/817.\u2019; (6) in Article 60, paragraph 6 is replaced by the following: \u20186. For the purpose of Article 15(4) and of paragraphs 3, 4 and 5 of this Article, eu-LISA shall store data referred to in Article 15(4) and in paragraph 3 of this Article which shall not allow for the identification of individuals in the central repository for reporting and statistics referred to in Article 39 of Regulation (EU) 2019/817. eu-LISA shall allow the Commission and the bodies referred to in paragraph 5 of this Article to obtain bespoke reports and statistics. Upon request, eu-LISA shall grant access to the central repository for reporting and statistics in accordance with Article 39 of Regulation (EU) 2019/817 to Member States, the Commission, Europol, and the European Border and Coast Guard Agency.\u2019. Article 64 Amendments to Decision 2004/512/EC In Article 1 of Decision 2004/512/EC, paragraph 2 is replaced by the following: \u20182. The Visa Information System shall be based on a centralised architecture and consist of: (a) the common identity repository central infrastructure as referred to in Article 17(2)(a) of Regulation (EU) 2019/817 of the European Parliament and of the Council (*11); (b) a central information system, hereinafter referred to as \u2018the Central Visa Information System\u2019 (CS-VIS); (c) an interface in each Member State, hereinafter referred to as the \u2018National Interface\u2019 (NI-VIS), to provide the connection to the relevant central national authority of the respective Member State; (d) a communication infrastructure between the Central Visa Information System and the National Interfaces; (e) a Secure Communication Channel between the EES Central System and the CS-VIS; (f) a secure communication infrastructure between the VIS Central System and the central infrastructure of the European search portal established by Article 6(1) of Regulation (EU) 2019/817 and of the common identity repository established by Article 17(1) of Regulation (EU) 2019/817. Article 65 Amendments to Decision 2008/633/JHA Decision 2008/633/JHA is amended as follows: (1) in Article 5, the following paragraph is inserted: \u20181a. In cases where the designated authorities have launched a query of the common identity repository (CIR) in accordance with Article 22 of Regulation (EU) 2019/817 of the European Parliament and of the Council (*12), and where the conditions for access laid down in this Article are met, they may access the VIS for consultation where the reply received as referred to in Article 22(2) of that Regulation reveals that data are stored in the VIS. (*12) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).\u2019;\" (2) in Article 7, the following paragraph is inserted: \u20181a. In cases where Europol has launched a query of the CIR in accordance with Article 22 of Regulation (EU) 2019/817, and where the conditions for access laid down in this Article are met, Europol may access the VIS for consultation where the reply received as referred to in Article 22(2) of that Regulation reveals that data are stored in the VIS.\u2019. CHAPTER X Final provisions Article 66 Reporting and statistics 1. The duly authorised staff of the competent authorities of Member States, the Commission and eu-LISA shall have access to consult the following data related to the ESP, solely for the purposes of reporting and statistics: (a) number of queries per ESP user profile; (b) number of queries to each of the Interpol databases. It shall not be possible to identify individuals from the data. 2. The duly authorised staff of the competent authorities of Member States, the Commission and eu-LISA shall have access to consult the following data related to the CIR, solely for the purposes of reporting and statistics: (a) number of queries for the purposes of Articles 20, 21 and 22; (b) nationality, gender and year of birth of the person; (c) the type of the travel document and the three-letter code of the issuing country; (d) the number of searches conducted with and without biometric data. It shall not be possible to identify individuals from the data. 3. The duly authorised staff of the competent authorities of Member States, the Commission and eu-LISA shall have access to consult the following data related to the MID, solely for the purposes of reporting and statistics: (a) the number of searches conducted with and without biometric data; (b) the number of each type of link and the EU information systems containing the linked data; (c) the period of time for which a yellow and red link remained in the system. It shall not be possible to identify individuals from the data. 4. The duly authorised staff of the European Border and Coast Guard Agency shall have access to consult the data referred to in paragraphs 1, 2 and 3 of this Article for the purpose of carrying out risk analyses and vulnerability assessments as referred to in Articles 11 and 13 of Regulation (EU) 2016/1624 of the European Parliament and of the Council (40). 5. The duly authorised staff of Europol shall have access to consult the data referred to in paragraphs 2 and 3 of this Article for the purpose of carrying out strategic, thematic and operational analyses as referred to in Article 18(2)(b) and (c) of Regulation (EU) 2016/794. 6. For the purpose of paragraphs 1, 2 and 3, eu-LISA shall store the data referred to in those paragraphs in the CRRS. It shall not be possible to identify individuals from the data included in the CRRS, but the data shall allow the authorities listed in paragraphs 1, 2 and 3 to obtain customisable reports and statistics to enhance the efficiency of border checks, to help authorities processing visa applications and to support evidence-based policy-making on migration and security in the Union. 7. Upon request, relevant information shall be made available by the Commission to the European Union Agency for Fundamental Rights in order to evaluate the impact of this Regulation on fundamental rights. Article 67 Transitional period for the use of the European search portal 1. For a period of two years from the date the ESP commences operations, the obligations referred to in Article 7(2) and (4) shall not apply and the utilisation of the ESP shall be optional. 2. The Commission is empowered to adopt a delegated act in accordance with Article 73 in order to amend this Regulation by extending the period referred to in paragraph 1 of this Article once, by no longer than one year, when an assessment of the implementation of the ESP has shown that such an extension is necessary, especially in view of the impact that bringing the ESP into operation would have on the organisation and length of border checks. Article 68 Transitional period applicable to the provisions on access to the common identity repository for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences Article 22, points 8 and 9 of Article 60, points 10 and 11 of Article 61 and Article 65 shall apply from the date of the start of operations of the CIR referred to in Article 72(3). Article 69 Transitional period for multiple-identity detection 1. For a period of one year following notification by eu-LISA of the completion of the test of the MID referred to in Article 72(4)(b) and before the start of operations of the MID, the ETIAS Central Unit shall be responsible for carrying out multiple-identity detection using the data stored in the EES, VIS, Eurodac and SIS. The multiple-identity detections shall be carried out using only biometric data. 2. Where the query reports one or several matches and the identity data in the linked files are the same or similar, a white link shall be created in accordance with Article 33. Where the query reports one or several matches and the identity data in the linked files cannot be considered to be similar, a yellow link shall be created in accordance with Article 30 and the procedure referred to in Article 29 shall apply. Where several matches are reported, a link shall be created between each piece of data triggering the match. 3. Where a yellow link is created, the MID shall grant access to the identity data present in the different EU information systems to the ETIAS Central Unit. 4. Where a link is created to an alert in SIS other than an alert created under Article 3 of Regulation (EU) 2018/1860, Articles 24 and 25 of Regulation (EU) 2018/1861, or Article 38 of Regulation (EU) 2018/1862, the MID shall grant access to the identity data present in the different information systems to the SIRENE Bureau of the Member State that created the alert. 5. The ETIAS Central Unit or, in the cases referred to in paragraph 4 of this Article the SIRENE Bureau of the Member State that created the alert, shall have access to the data contained in the identity confirmation file and shall assess the different identities and shall update the link in accordance with Articles 31, 32 and 33 and add it to the identity confirmation file. 6. The ETIAS Central Unit shall notify the Commission in accordance with Article 71(3) only once all yellow links have been manually verified and their status updated as either green, white or red links. 7. Member States shall assist the ETIAS Central Unit where necessary in carrying out multiple-identity detection under this Article. 8. The Commission is empowered to adopt a delegated act in accordance with Article 73 in order to amend this Regulation by extending the period referred to in paragraph 1 of this Article by six months, renewable twice by six months each time. Such an extension shall only be granted following an assessment of the estimated completion time for multiple-identity detection under this Article, which demonstrates that the multiple-identity detection cannot be completed before expiry of the period remaining either under paragraph 1 of this Article or any ongoing extension, for reasons independent of the ETIAS Central Unit, and that no corrective measures can be applied. The assessment shall be carried out no later than three months before the expiry of such period or ongoing extension. Article 70 Costs 1. The costs incurred in connection with the establishment and operation of the ESP, the shared BMS, the CIR and the MID shall be borne by the general budget of the Union. 2. Costs incurred in connection with the integration of the existing national infrastructures and their connection to the national uniform interfaces as well as in connection with hosting the national uniform interfaces shall be borne by the general budget of the Union. The following costs shall be excluded: (a) Member States' project management office (meetings, missions, offices); (b) hosting of national IT systems (space, implementation, electricity, cooling); (c) operation of national IT systems (operators and support contracts); (d) design, development, implementation, operation and maintenance of national communication networks. 3. Without prejudice to further funding for this purpose from other sources of the general budget of the European Union, an amount of EUR 32 077 000 shall be mobilised from the envelope of EUR 791 000 000 foreseen under Article 5(5)(b) of Regulation (EU) No 515/2014 to cover the costs of implementation of this Regulation, as foreseen under paragraphs 1 and 2 of this Article. 4. From the envelope referred to in paragraph 3, EUR 22 861 000 shall be allocated to eu-LISA, EUR 9 072 000 shall be allocated to Europol and EUR 144 000 shall be allocated to the European Union Agency for Law Enforcement Training (CEPOL) to support these agencies in performing their respective tasks under this Regulation. Such funding shall be implemented under indirect management. 5. The costs incurred by the designated authorities shall be borne by the designating Member States respectively. The costs of connecting each designated authority to the CIR shall be borne by each Member State. The costs incurred by Europol, including of connection to the CIR, shall be borne by Europol. Article 71 Notifications 1. The Member States shall notify eu-LISA of the authorities referred to in Articles 7, 20, 21 and 26 that may use or have access to the ESP, the CIR and the MID respectively. A consolidated list of those authorities shall be published in the Official Journal of the European Union within a period of three months from the date on which each interoperability component commenced operations in accordance with Article 72. Where there are amendments to the list, eu-LISA shall publish an updated consolidated list once a year. 2. eu-LISA shall notify the Commission of the successful completion of the tests referred to in Article 72(1)(b), (2)(b), (3)(b), (4)(b), (5)(b) and (6)(b). 3. The ETIAS Central Unit shall notify the Commission of the successful completion of the transitional period laid down in Article 69. 4. The Commission shall make the information notified pursuant to paragraph 1 available to the Member States and to the public, via a constantly updated public website. Article 72 Start of operations 1. The Commission shall determine the date from which the ESP is to start operations by means of an implementing act once the following conditions have been met: (a) the measures referred to in Articles 8(2), 9(7) and 43(5) have been adopted; (b) eu-LISA has declared the successful completion of a comprehensive test of the ESP, which it has conducted in cooperation with the Member States authorities and the Union agencies that may use the ESP; (c) eu-LISA has validated the technical and legal arrangements to collect and transmit the data referred to in Article 8(1) and has notified them to the Commission. The ESP shall only query the Interpol databases once the technical arrangements allow compliance with Article 9(5). Any impossibility of complying with Article 9(5) shall have the result that the ESP does not query the Interpol databases but shall not delay the start of operations of the ESP. The Commission shall set the date referred to in the first subparagraph to be within 30 days from adoption of the implementing act. 2. The Commission shall determine the date from which the shared BMS is to start operations by means of an implementing act once the following conditions have been met: (a) the measures referred to in Articles 13(5) and 43(5) have been adopted; (b) eu-LISA has declared the successful completion of a comprehensive test of the shared BMS, which it has conducted in cooperation with the Member States authorities; (c) eu-LISA has validated the technical and legal arrangements to collect and transmit the data referred to in Article 13 and has notified them to the Commission; (d) eu-LISA has declared the successful completion of the test referred to in paragraph 5(b). The Commission shall set the date referred to in the first subparagraph to be within 30 days from adoption of the implementing act. 3. The Commission shall determine the date from which the CIR is to start operations by means of an implementing act once the following conditions have been met: (a) the measures referred to in Articles 43(5) and 78(10) have been adopted; (b) eu-LISA has declared the successful completion of a comprehensive test of the CIR, which it has conducted in cooperation with the Member States authorities; (c) eu-LISA has validated the technical and legal arrangements to collect and transmit the data referred to in Article 18 and has notified them to the Commission; (d) eu-LISA has declared the successful completion of the test referred to in paragraph 5(b). The Commission shall set the date referred to in the first subparagraph to be within 30 days from adoption of the implementing act. 4. The Commission shall determine the date from which the MID is to start operations by means of an implementing act once the following conditions have been met: (a) the measures referred to in Articles 28(5) and (7), 32(5), 33(6), 43(5) and 49(6) have been adopted; (b) eu-LISA has declared the successful completion of a comprehensive test of the MID, which it has conducted in cooperation with the Member States authorities and the ETIAS Central Unit; (c) eu-LISA has validated the technical and legal arrangements to collect and transmit the data referred to in Article 34 and has notified them to the Commission; (d) the ETIAS Central Unit has notified the Commission in accordance with Article 71(3); (e) eu-LISA has declared the successful completion of the tests referred to in paragraphs 1(b), 2(b), 3(b) and 5(b). The Commission shall set the date referred to in the first subparagraph to be within 30 days from adoption of the implementing act. 5. The Commission shall determine by means of implementing acts the date from which the automated data quality control mechanisms and procedures, the common data quality indicators and the minimum data quality standards are to be used, once the following conditions have been met: (a) the measures referred to in Articles 37(4) have been adopted; (b) eu-LISA has declared the successful completion of a comprehensive test of the automated data quality control mechanisms and procedures, the common data quality indicators and the minimum data quality standards, which it has conducted in cooperation with the Member States authorities. The Commission shall set the date referred to in the first subparagraph to be within 30 days from adoption of the implementing act. 6. The Commission shall determine the date from which the CRRS is to start operations by means of an implementing act once the following conditions have been met: (a) the measures referred to in Articles 39(5) and 43(5) have been adopted; (b) eu-LISA has declared the successful completion of a comprehensive test of the CRRS, which it has conducted in cooperation with the Member States authorities; (c) eu-LISA has validated the technical and legal arrangements to collect and transmit the data referred to in Article 39 and has notified them to the Commission. The Commission shall set the date referred to in the first subparagraph to be within 30 days from adoption of the implementing act. 7. The Commission shall inform the European Parliament and the Council of the results of the tests carried out pursuant to paragraphs 1(b), 2(b), 3(b), 4(b), 5(b) and 6(b). 8. Member States, the ETIAS Central Unit and Europol shall start using each of the interoperability components from the date determined by the Commission in accordance with paragraphs 1, 2, 3 and 4 respectively. Article 73 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 28(5), 39(5), 49(6), 67(2) and 69(8) shall be conferred on the Commission for a period of five years from 11 June 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 28(5), 39(5), 49(6), 67(2) and 69(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 28(5), 39(5), 49(6), 67(2) and 69(8) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 74 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 75 Advisory Group An Interoperability Advisory Group shall be established by eu-LISA. During the design and development phase of the interoperability components, Article 54(4), (5) and (6) shall apply. Article 76 Training eu-LISA shall perform tasks related to the provision of training on the technical use of the interoperability components in accordance with Regulation (EU) 2018/1726. Member States authorities and Union agencies shall provide their staff authorised to process data using the interoperability components, with appropriate training programmes concerning data security, data quality, data protection rules, the procedures applicable to data processing and the obligations to inform under Articles 32(4), 33(4) and 47. Where appropriate, joint training courses on these topics shall be organised at Union level to enhance cooperation and the exchange of best practices between the staff of Member States authorities and Union agencies who are authorised to process data using the interoperability components. Particular attention shall be paid to the process of multiple-identity detection, including the manual verification of different identities and the accompanying need to maintain appropriate safeguards of fundamental rights. Article 77 Practical handbook The Commission shall, in close cooperation with the Member States, eu-LISA and other relevant Union agencies, make available a practical handbook for the implementation and management of the interoperability components. The practical handbook shall provide technical and operational guidelines, recommendations and best practices. The Commission shall adopt the practical handbook in the form of a recommendation. Article 78 Monitoring and evaluation 1. eu-LISA shall ensure that procedures are in place to monitor the development of the interoperability components and their connection to the national uniform interface in light of objectives relating to planning and costs and to monitor the functioning of the interoperability components in light of objectives relating to the technical output, cost-effectiveness, security and quality of service. 2. By 12 December 2019 and every six months thereafter during the development phase of the interoperability components, eu-LISA shall submit a report to the European Parliament and to the Council on the state of play of the development of the interoperability components, as well as their connection to the national uniform interface. Once the development is finalised, a report shall be submitted to the European Parliament and to the Council explaining in detail how the objectives, in particular relating to planning and costs, were achieved, as well as justifying any divergences. 3. Four years after the start of operations of each interoperability component in accordance with Article 72 and every four years thereafter, eu-LISA shall submit to the European Parliament, to the Council and to the Commission a report on the technical functioning of the interoperability components, including their security. 4. In addition, one year after each report from eu-LISA, the Commission shall produce an overall evaluation of the interoperability components, including: (a) an assessment of the application of this Regulation; (b) an examination of the results achieved against the objectives of this Regulation and its impact on fundamental rights, including in particular an assessment of the impact of the interoperability components on the right to non-discrimination; (c) an assessment of the functioning of the web portal, including figures regarding the use of the web portal and the number of requests that were resolved; (d) an assessment of the continuing validity of the underlying rationale of the interoperability components; (e) an assessment of the security of the interoperability components; (f) an assessment of the use of the CIR for identification; (g) an assessment of the use of the CIR for preventing, detecting or investigating terrorist offences or other serious criminal offences; (h) an assessment of any implications, including any disproportionate impact on the flow of traffic at border crossing points and those with a budgetary impact on the general budget of the Union; (i) an assessment of the search of the Interpol databases via the ESP, including information on the number of matches against Interpol databases and information on any problems encountered. The overall evaluation under the first subparagraph of this paragraph shall include any necessary recommendations. The Commission shall transmit the evaluation report to the European Parliament, to the Council, to the European Data Protection Supervisor and to the European Union Agency for Fundamental Rights. 5. By 12 June 2020 and every year thereafter until the implementing acts of the Commission referred to in Article 72 have been adopted, the Commission shall submit a report to the European Parliament and to the Council on the state of play of preparations for the full implementation of this Regulation. That report shall contain also detailed information about the costs incurred and information as to any risks which may impact the overall costs. 6. Two years after the start of operations of the MID in accordance with Article 72(4), the Commission shall produce an examination of the impact of the MID on the right to non-discrimination. Following this first report, the examination of the impact of the MID on the right to non-discrimination shall be part of the examination referred to in paragraph 4(b) of this Article. 7. The Member States and Europol shall provide eu-LISA and the Commission with the information necessary to draft the reports referred to in paragraphs 3 to 6. This information shall not jeopardise working methods or include information that reveals sources, staff members or investigations of the designated authorities. 8. eu-LISA shall provide the Commission with the information necessary to produce the overall evaluation referred to in paragraph 4. 9. While respecting the provisions of national law on the publication of sensitive information, and without prejudice to limitations necessary to protect security and public order, prevent crime and guarantee that no national investigation will be jeopardised, each Member State and Europol shall prepare annual reports on the effectiveness of access to data stored in the CIR for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences, containing information and statistics on: (a) the exact purposes of the consultations including the types of terrorist offences or other serious criminal offences; (b) the reasonable grounds given for a substantiated suspicion that a suspect, perpetrator or victim is covered by Regulation (EU) 2017/2226, Regulation (EC) No 767/2008 or Regulation (EU) 2018/1240; (c) the number of requests for access to the CIR for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences; (d) the number and types of cases that have ended in successful identifications; (e) the need and use made of the exceptions for cases of urgency including those cases where that urgency was not accepted by the ex post verification carried out by the central access point. The annual reports prepared by the Member State and Europol shall be transmitted to the Commission by 30 June of the subsequent year. 10. A technical solution shall be made available to Member States in order to manage user access requests referred to in Article 22 and to facilitate the collection of the information under paragraphs 7 and 9 of this Article for the purpose of generating reports and statistics referred to in those paragraphs. The Commission shall adopt implementing acts to lay down the specifications of the technical solution. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2). Article 79 Entry into force and applicability This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. The provisions of this Regulation related to the ESP shall apply from the date determined by the Commission in accordance with Article 72(1). The provisions of this Regulation related to the shared BMS shall apply from the date determined by the Commission in accordance with Article 72(2). The provisions of this Regulation related to the CIR shall apply from the date determined by the Commission in accordance with Article 72(3). The provisions of this Regulation related to the MID shall apply from the date determined by the Commission in accordance with Article 72(4). The provisions of this Regulation related to the automated data quality control mechanisms and procedures, the common data quality indicators and the minimum data quality standards shall apply respectively from the dates determined by the Commission in accordance with Article 72(5). The provisions of this Regulation related to the CRRS shall apply from the date determined by the Commission in accordance with Article 72(6). Articles 6, 12, 17, 25, 38, 42, 54, 56, 57, 70, 71, 73, 74, 75, 77 and 78(1) shall apply from 11 June 2019. This Regulation shall apply in relation to Eurodac from the date the recast of Regulation (EU) No 603/2013 becomes applicable. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 20 May 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 283, 10.8.2018, p. 48. (2) Position of the European Parliament of 16 April 2019 (not yet published in the Official Journal) and decision of the Council of 14 May 2019. (3) OJ C 101, 16.3.2018, p. 116. (4) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (5) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (6) Council Common Position 2005/69/JHA of 24 January 2005 on exchanging certain data with Interpol (OJ L 27, 29.1.2005, p. 61). (7) Council Decision 2007/533/JHA of 12 June 2007 on the establishment, operation and use of the second generation Schengen Information System (SIS II) (OJ L 205, 7.8.2007, p. 63). (8) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (9) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). (10) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1). (11) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, p. 14). (12) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56). (13) Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing the external borders of the Member States and determining the conditions for access to the EES for law enforcement purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (EES Regulation) (OJ L 327, 9.12.2017, p. 20). (14) Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning the Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (VIS Regulation) (OJ L 218, 13.8.2008, p. 60). (15) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1). (16) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53). (17) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (18) OJ C 233, 4.7.2018, p. 12. (19) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (20) Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing as part of the Internal Security Fund, the Instrument for financial support for externalborders and visa and repealing Decision No 574/2007/EC (OJ L 150, 20.5.2014, p. 143). (21) OJ L 123, 12.5.2016, p. 1. (22) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (23) Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77). (24) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (25) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (26) OJ L 176, 10.7.1999, p. 36. (27) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (28) OJ L 53, 27.2.2008, p. 52. (29) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (30) OJ L 160, 18.6.2011, p. 21. (31) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (32) Council Decision 2004/512/EC of 8 June 2004 establishing the Visa Information System (VIS) (OJ L 213, 15.6.2004, p. 5). (33) Council Decision 2008/633/JHA of 23 June 2008 concerning access for consultation of the Visa Information System (VIS) by designated authorities of Member States and by Europol for the purposes of the prevention, detection and investigation of terrorist offences and of other serious criminal offences (OJ L 218, 13.8.2008, p. 129). (34) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (See page 85 of this Official Journal). (35) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, p. 6). (36) Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (OJ L 190, 18.7.2002, p. 1). (37) Regulation (EU) No 603/2013 of the European Parliament and of the Council of 26 June 2013 on the establishment of \u2018Eurodac\u2019 for the comparison of fingerprints for the effective application of Regulation (EU) No 604/2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes, and amending Regulation (EU) No 1077/2011 establishing a European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice (OJ L 180, 29.6.2013, p. 1). (38) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 (See page 1 of this Official Journal). (39) Council Regulation (EC) No 168/2007 of 15 February 2007 establishing a European Union Agency for Fundamental Rights (OJ L 53, 22.2.2007, p. 1). (40) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1).", "summary": "Interoperability between EU information systems in the field of freedom, security and justice Interoperability between EU information systems in the field of freedom, security and justice SUMMARY OF: Regulation (EU) 2019/817 establishing a framework for interoperability between EU information systems in the field of borders and visa Regulation (EU) 2019/818 establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration WHAT IS THE AIM OF THE REGULATIONS? They aim to improve checks at the EU\u2019s external borders, allow for better detection of security threats and identity fraud and help in preventing and combating illegal immigration. KEY POINTS Scope The 2 interoperability regulations cover: 3 existing centralised EU information systems for borders and security \u2014 the Schengen information system (SIS), the visa information system (VIS) and the European system for the comparison of fingerprints of asylum applicants (Eurodac); 3 centralised EU information systems under development \u2014 the Entry/Exit System (EES), the European Travel Information and Authorisation System (ETIAS) and the European Criminal Records Information System \u2014 Third Country Nationals; data from the European Union Agency for Law Enforcement Cooperation (Europol). The EU information systems in freedom, security and justice are managed by the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice. Components The regulations set up the following interoperability components: a European search portal allowing competent authorities to search multiple information systems simultaneously, using both biographical and biometric data; a shared biometric matching service enabling the searching and comparing of biometric data (fingerprints and facial images) from several EU information systems; a common identity repository containing biographical and biometric data of non-EU nationals available in several EU information systems; a multiple identity detector enabling the detection of multiple identities across different EU information systems. Access The regulations do not change the rights of access to the individual EU information systems, but will ease and improve information-sharing. They provide for a new 2-step approach to grant law enforcement authorities access to the EES, VIS, ETIAS and Eurodac: initial searches would be carried out on a \u2018hit/no hit\u2019 basis;if a \u2018hit\u2019 were obtained, law enforcement authorities could then access any further information needed, in line with the respective rules and safeguards. FROM WHEN DO THE REGULATIONS APPLY? They have applied since 11 June 2019. BACKGROUND Regulation (EU) 2019/817 amends Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 and Council Decisions 2004/512/EC and 2008/633/JHA. Regulation (EU) 2019/818 amends Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816. For more information, see: IT systems in the area of freedom, security and justice (Council of the European Union). MAIN DOCUMENTS Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, pp. 27-84) Successive amendments to Regulation (EU) 2019/817 have been incorporated into the original document. This consolidated version is of documentary value only. Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ L 135, 22.5.2019, pp. 85-135) See consolidated version. RELATED DOCUMENTS Regulation (EU) 2021/1133 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EU) No 603/2013, (EU) 2016/794, (EU) 2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards the establishment of the conditions for accessing other EU information systems for the purposes of the Visa Information System (OJ L 248, 13.7.2021, pp. 1-10) Regulation (EU) 2021/1134 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EC) No 767/2008, (EC) No 810/2009, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1860, (EU) 2018/1861, (EU) 2019/817 and (EU) 2019/1896 of the European Parliament and of the Council and repealing Council Decisions 2004/512/EC and 2008/633/JHA, for the purpose of reforming the Visa Information System (OJ L 248, 13.7.2021, pp. 11-87) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, pp. 1-26) See consolidated version. Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, pp. 14-55) See consolidated version. Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, pp. 56-106) See consolidated version. Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, pp. 99-137) See consolidated version. Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, pp. 1-71) See consolidated version. Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing the external borders of the Member States and determining the conditions for access to the EES for law enforcement purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, pp. 20-82) See consolidated version. Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, pp. 1-52) See consolidated version. Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning the Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (VIS Regulation) (OJ L 218, 13.8.2008, pp. 60-81) See consolidated version. Council Decision 2008/633/JHA of 23 June 2008 concerning access for consultation of the Visa Information System (VIS) by designated authorities of Member States and by Europol for the purposes of the prevention, detection and investigation of terrorist offences and of other serious criminal offences (OJ L 218, 13.8.2008, pp. 129-136) See consolidated version. Council Decision 2004/512/EC of 8 June 2004 establishing the Visa Information System (VIS) (OJ L 213, 15.6.2004, pp. 5-7) See consolidated version. last update 26.08.2021"}
{"article": "21.12.2018 EN Official Journal of the European Union L 328/82 DIRECTIVE (EU) 2018/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on the promotion of the use of energy from renewable sources (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Directive 2009/28/EC of the European Parliament and of the Council (4) has been substantially amended several times (5). Since further amendments are to be made, that Directive should be recast in the interests of clarity. (2) In accordance with Article 194(1) of the Treaty on the Functioning of the European Union (TFEU), promoting renewable forms of energy is one of the goals of the Union energy policy. That goal is pursued by this Directive. The increased use of energy from renewable sources or \u2018renewable energy\u2019 constitutes an important part of the package of measures needed to reduce greenhouse gas emissions and comply with the Union's commitment under the 2015 Paris Agreement on Climate Change following the 21st Conference of the Parties to the United Nations Framework Convention on Climate Change (the \u2018Paris Agreement\u2019), and with the Union 2030 energy and climate framework, including the Union's binding target to cut emissions by at least 40 % below 1990 levels by 2030. The Union's binding renewable energy target for 2030 and Member States' contributions to that target, including their baseline shares in relation to their national overall targets for 2020, are among the elements which have an overarching importance for the Union's energy and environmental policy. Other such elements are contained in the framework set out in this Directive, for instance, for the development of renewable heating and cooling and the development of renewable transport fuels. (3) The increased use of energy from renewable sources also has a fundamental part to play in promoting the security of energy supply, sustainable energy at affordable prices, technological development and innovation as well as technological and industrial leadership while providing environmental, social and health benefits as well as major opportunities for employment and regional development, especially in rural and isolated areas, in regions or territories with low population density or undergoing partial deindustrialisation. (4) In particular, reducing energy consumption, increasing technological improvements, incentives for the use and expansion of public transport, the use of energy efficiency technologies and the promotion of the use of renewable energy in the electricity sector, the heating and cooling sector and the transport sector are effective tools, together with energy efficiency measures, for reducing greenhouse gas emissions in the Union and the Union's energy dependence. (5) Directive 2009/28/EC established a regulatory framework for the promotion of the use of energy from renewable sources which set binding national targets on the share of renewable energy in energy consumption and in the transport sector to be met by 2020. The Commission Communication of 22 January 2014 entitled \u2018A policy framework for climate and energy in the period from 2020 to 2030\u2019, established a framework for future Union energy and climate policies and promoted a common understanding of how to develop those policies after 2020. The Commission proposed that the Union 2030 target for the share of renewable energy consumed in the Union should be at least 27 %. That proposal was endorsed by the European Council in its conclusions of 23 and 24 October 2014, which indicated that Member States should be able to set their own, more ambitious, national targets in order to deliver their planned contributions to the Union 2030 target and exceed them. (6) In its resolutions of 5 February 2014 entitled \u2018A 2030 framework for climate and energy policies\u2019 and of 23 June 2016 entitled \u2018The renewable energy progress report\u2019, the European Parliament went further than the Commission proposal or the European Council conclusions, stressing that, in light of the Paris Agreement and the recent renewable technology cost reductions, it was desirable to be significantly more ambitious. (7) The ambition set out in the Paris Agreement as well as technological developments, including cost reductions for investments in renewable energy, should therefore be taken into account. (8) It is thus appropriate to establish a binding Union target of a share of at least 32 % of renewable energy. Moreover, the Commission should assess whether that target should be reviewed upwards in light of substantial cost reductions in the production of renewable energy, the Union's international commitments for decarbonisation, or in the case of a significant decrease in energy consumption in the Union. Member States should establish their contribution to the achievement of that target as part of their integrated national energy and climate plans pursuant to the governance process laid down in Regulation (EU) 2018/1999 of the European Parliament and of the Council (6). (9) The establishment of a binding Union renewable energy target for 2030 would continue to encourage the development of technologies which produce renewable energy and provide certainty for investors. A target defined at Union level would leave greater flexibility for Member States to meet their greenhouse gas reduction targets in the most cost-effective manner in accordance with their specific circumstances, energy mix and capacity to produce renewable energy. (10) In order to ensure consolidation of the results achieved under Directive 2009/28/EC, the national targets set for 2020 should constitute Member States' minimum contributions to the new 2030 framework. Under no circumstances should the national shares of renewable energy fall below those contributions. If they do, the relevant Member States should take appropriate measures as provided for in Regulation (EU) 2018/1999 to ensure that that baseline share is regained. If a Member State does not maintain its baseline share over a 12-month period, it should, within 12 months of the end of that period, take additional measures to regain that baseline share. Where a Member State has effectively taken such additional measures and has fulfilled its obligation to regain the baseline share, it should be deemed to have complied with the mandatory baseline share requirements under this Directive and under Regulation (EU) 2018/1999 for the entire period in question. The Member State in question cannot therefore be considered to have failed to fulfil its obligation to maintain its baseline share for the period in time where the gap occurred. Both the 2020 and 2030 frameworks serve the environmental and energy policy objectives of the Union. (11) Member States should take additional measures in the event that the share of renewable energy at Union level does not meet the Union trajectory towards the renewable energy target of at least 32 %. Under Regulation (EU) 2018/1999 the Commission may take measures at Union level in order to ensure achievement of the target if an ambition gap is identified by the Commission during the assessment of the integrated national energy and climate plans. If the Commission identifies a delivery gap during its assessment of the integrated national energy and climate progress reports, Member States should apply the measures provided for in Regulation (EU) 2018/1999 to close that gap. (12) In order to support Member States' ambitious contributions to the Union target, a financial framework aiming to facilitate investments in renewable energy projects in those Member States should be established, including through the use of financial instruments. (13) The Commission should focus the allocation of funds on the reduction of the cost of capital of renewable energy projects since such cost has a material impact on the cost of renewable energy projects and on their competitiveness, as well as on the development of essential infrastructure for an enhanced technically feasible and economically affordable uptake of renewable energy such as transmission and distribution grid infrastructure, intelligent networks and interconnections. (14) The Commission should facilitate the exchange of best practices between the competent national or regional authorities or bodies, for instance through regular meetings, to find a common approach to promote a higher uptake of cost-efficient renewable energy projects. The Commission should also encourage investments in new, flexible and clean technologies, and establish an adequate strategy to manage the retirement of technologies which do not contribute to the reduction of emissions or deliver sufficient flexibility, based on transparent criteria and reliable market price signals. (15) Regulation (EC) No 1099/2008 of the European Parliament and of the Council (7), Directives 2001/77/EC (8) and 2003/30/EC (9) of the European Parliament and of the Council, and Directive 2009/28/EC established definitions for different types of energy from renewable sources. Union law on the internal market for energy establishes definitions for the electricity sector in general. In the interests of clarity and legal certainty it is appropriate to apply those definitions in this Directive. (16) Support schemes for electricity from renewable sources or \u2018renewable electricity\u2019 have been demonstrated to be an effective way of fostering deployment of renewable electricity. If and when Member States decide to implement support schemes, such support should be provided in a form that is as non-distortive as possible for the functioning of electricity markets. To that end, an increasing number of Member States allocate support in a form by means of which support is granted in addition to market revenues and introduce market-based systems to determine the necessary level of support. Together with steps by which to make the market fit for increasing shares of renewable energy, such support is a key element of increasing the market integration of renewable electricity, while taking into account the different capabilities of small and large producers to respond to market signals. (17) Small-scale installations can be of great benefit to increase public acceptance and to ensure the rollout of renewable energy projects, in particular at local level. In order to ensure participation of such small-scale installations, specific conditions, including feed-in tariffs, might therefore still be necessary to ensure a positive cost-benefit ratio, in accordance with Union law relating to the electricity market. The definition of small-scale installations for the purposes of obtaining such support is important to provide legal certainty for investors. State aid rules contain definitions of small-scale installations. (18) Pursuant to Article 108 TFEU, the Commission has exclusive competence to assess the compatibility of State aid measures with the internal market which the Member States may put in place for deployment of energy from renewable sources. That assessment is carried out on the basis of Article 107(3) TFEU and in accordance with the relevant provisions and guidelines which the Commission may adopt to that effect. This Directive is without prejudice to the Commission's exclusive competence granted by the TFEU. (19) Electricity from renewable sources should be deployed at the lowest possible cost to consumers and taxpayers. When designing support schemes and when allocating support, Member States should seek to minimise the overall system cost of deployment along the decarbonisation pathway towards the objective of a low-carbon economy by the year 2050. Market-based mechanisms, such as tendering procedures, have been demonstrated to reduce support cost effectively in competitive markets in many circumstances. However, in specific circumstances, tendering procedures may not necessarily lead to efficient price discovery. Balanced exemptions may therefore need to be considered to ensure cost-effectiveness and minimise overall support cost. In particular, Member States should be allowed to grant exemptions from tendering procedures and direct marketing to small-scale installations and demonstration projects in order to take into account their more limited capabilities. Since the Commission assesses the compatibility of support for renewable energy with the internal market on a case-by-case basis, such exemptions should comply with the relevant thresholds set out in the latest Commission Guidelines on State aid for environmental protection and energy. In the Guidelines for 2014 to 2020, those thresholds are set at 1 MW (and 6 MW or 6 generation units for wind energy) and 500 kW (and 3 MW or 3 generation units for wind energy) in terms of exemptions from, respectively, tendering procedures and direct marketing. To increase the effectiveness of tendering procedures to minimise overall support costs, tendering procedures should, in principle, be open to all producers of electricity from renewable sources on a non-discriminatory basis. While Member States develop their support schemes, they may limit tendering procedures to specific technologies where this is needed to avoid sub-optimal results with regard to network constraints and grid stability, system integration costs, the need to achieve diversification of the energy mix, and the long-term potential of technologies. (20) In its conclusions of 23 and 24 October 2014 on the \u20182030 Climate and Energy Policy Framework\u2019, the European Council stressed the importance of a more interconnected internal energy market and the need for sufficient support to integrate ever increasing levels of variable renewable energy and thus allow the Union to fulfil its leadership ambitions for the energy transition. It is therefore important and urgent to increase the level of interconnection and to make progress towards the European Council's objectives, in order to maximise the Energy Union's full potential. (21) When developing support schemes for renewable sources of energy, Member States should consider the available sustainable supply of biomass and take due account of the principles of the circular economy and of the waste hierarchy established in Directive 2008/98/EC of the European Parliament and of the Council (10) in order to avoid unnecessary distortions of raw materials markets. Waste prevention and recycling of waste should be the priority option. Member States should avoid creating support schemes which would be counter to targets on treatment of waste and which would lead to the inefficient use of recyclable waste. (22) Member States have different renewable energy potentials and operate different support schemes at national level. The majority of Member States apply support schemes that grant benefits solely to energy from renewable sources that is produced on their territory. For the proper functioning of national support schemes, it is vital that Member States continue to be able to control the effect and costs of their national support schemes in accordance with their different potentials. One important means by which to achieve the aim of this Directive remains to guarantee the proper functioning of national support schemes under Directives 2001/77/EC and 2009/28/EC, in order to maintain investor confidence and allow Member States to design effective national measures for their respective contributions to the Union's 2030 target for renewable energy and for the national targets that they have set for themselves. This Directive should facilitate cross-border support for renewable energy without affecting national support schemes in a disproportionate manner. (23) The opening of support schemes to cross-border participation limits negative impacts on the internal energy market and can, under certain conditions, help Member States achieve the Union target more cost-efficiently. Cross-border participation is also the natural corollary to the development of the Union renewable energy policy, fostering convergence and cooperation to contribute to the Union's binding target. It is therefore appropriate to encourage Member States to open support to projects located in other Member States, and define several ways in which such progressive opening may be implemented, ensuring compliance with the TFEU, in particular Articles 30, 34 and 110 thereof. As electricity flows cannot be traced, it is appropriate to link the opening of support schemes to cross-border participation to shares representing an aspiration towards actual levels of physical interconnection and to allow Member States to restrict their open support schemes to Member States with which they have a direct network connection as a practical proxy for demonstrating the existence of physical flows between the Member States. This should not, however, in any way affect the cross-zonal or cross-border functioning of the electricity markets. (24) In order to ensure that the opening of support schemes is reciprocal and brings mutual benefits, cooperation agreements should be signed between participating Member States. Member States should retain control over the pace of deployment of renewable electricity capacity on their territory in order, in particular, to take account of associated integration costs and required grid investments. Member States should thus be allowed to limit the participation of installations located on their territory to tenders opened to them by other Member States. Those cooperation agreements should address all relevant aspects, such as accounting for costs relating to a project built by one Member State on the territory of another, including the expenditure relating to strengthening networks, energy transfer, storage and back-up capacity, as well as possible congestions in the network. In those agreements Member States should also take into account measures that may allow for the cost-effective integration of such additional renewable electricity capacity, whether they are of a regulatory nature (for instance related to market design) or provide for additional investments in various sources of flexibility (for instance interconnections, storage, demand response or flexible generation). (25) Member States should avoid distortive situations resulting in the extensive importation of resources from third countries. A life-cycle approach should be considered and promoted in that respect. (26) Member States should ensure that renewable energy communities can participate in available support schemes on an equal footing with large participants. To that end, Member States should be allowed to take measures, such as providing information, providing technical and financial support, reducing administrative requirements, including community-focused bidding criteria, creating tailored bidding windows for renewable energy communities, or allowing renewable energy communities to be remunerated through direct support where they comply with requirements of small installations. (27) The planning of the infrastructure needed for the production of electricity from renewable sources should take into account policies relating to the participation of those affected by the projects, in particular local populations. (28) Consumers should be provided with comprehensive information, including information on the energy performance of heating and cooling systems and on the lower running costs of electric vehicles, to allow them to make individual consumer choices with regard to renewable energy and avoid technology lock-in. (29) Without prejudice to Articles 107 and 108 TFEU, policies supporting renewable energy should be predictable and stable and should avoid frequent or retroactive changes. Policy unpredictability and instability have a direct impact on capital financing costs, on the costs of project development and therefore on the overall cost of deploying renewable energy in the Union. Member States should prevent the revision of any support granted to renewable energy projects from having a negative impact on their economic viability. In that context, Member States should promote cost-effective support policies and ensure their financial sustainability. Moreover, a long-term indicative schedule covering the main aspects of the expected support should be published, without affecting the ability of Member States to decide on budget allocation in the years covered by the schedule. (30) Member States' obligations to draft renewable energy action plans and progress reports and the Commission's obligation to report on Member States' progress are essential in order to increase transparency, provide clarity to investors and consumers and allow for effective monitoring. Regulation (EU) 2018/1999 integrates those obligations in the Energy Union governance system, where planning, reporting and monitoring obligations in the energy and climate fields are streamlined. The transparency platform on renewable energy is also integrated in the broader e-platform established in that Regulation. (31) It is necessary to provide for transparent and unambiguous rules for calculating the share of energy from renewable sources and for defining those sources. (32) In calculating the contribution of hydropower and wind power for the purposes of this Directive, the effects of climatic variation should be smoothed through the use of a normalisation rule. Further, electricity produced in pumped storage units from water that has previously been pumped uphill should not be considered to be renewable electricity. (33) In order to function, heat pumps enabling the use of ambient and geothermal energy at a useful temperature level or systems providing cooling need electricity or other auxiliary energy. The energy used to drive those systems should therefore be deducted from the total usable energy or energy removed from the area. Only heating and cooling systems where the output or energy removed from an area significantly exceeds the primary energy needed to drive them should be taken into account. Cooling systems contribute to energy use in Member States and it is therefore appropriate that the calculation methods take into account the share of renewable energy used in such systems in all end-use sectors. (34) Passive energy systems use building design to harness energy. This is considered to be saved energy. To avoid double counting, energy harnessed in this way should not be taken into account for the purposes of this Directive. (35) Some Member States have a large share of aviation in their gross final consumption of energy. In view of the current technological and regulatory constraints that prevent the commercial use of biofuels in aviation, it is therefore appropriate to provide those Member States with a partial exemption within the calculation of the gross final consumption of energy in the national air transport sector in order to allow them to exclude from that calculation the amount by which they exceed one-and-a-half times the Union average gross final consumption of energy in aviation in 2005, as assessed by Eurostat, namely, 6,18 %. Due to their insular and peripheral character, Cyprus and Malta rely in particular on aviation as a mode of transport, which is essential for their citizens and their economy. As a result, their gross final consumption of energy in the national air transport sector is disproportionally high, namely, more than three times the Union average in 2005. They are thus disproportionately affected by the current technological and regulatory constraints. It is therefore appropriate to provide that they benefit from an exemption covering the amount by which they exceed the Union average gross final consumption of energy in aviation in 2005 as assessed by Eurostat, namely, 4,12 %. (36) The communication of the Commission of 20 July 2016 entitled \u2018A European Strategy for Low-Emission Mobility\u2019, highlighted the particular importance, in the medium term, of advanced biofuels and renewable liquid and gaseous fuels of non-biological origin for aviation. (37) In order to ensure that the list of feedstock to produce advanced biofuels, other biofuels and biogas, as set out in an annex to this Directive, takes into account the principles of the waste hierarchy established in Directive 2008/98/EC, the Union sustainability criteria, and the need to ensure that that annex does not create additional demand for land while promoting the use of wastes and residues, the Commission, when regularly evaluating that annex, should consider the inclusion of additional feedstock that does not cause significant distortive effects on markets for (by-)products, wastes or residues. (38) To create opportunities for reducing the cost of meeting the Union target laid down in this Directive and to give flexibility to Member States to comply with their obligation not to fall below their 2020 national targets after 2020, it is appropriate both to facilitate the consumption in Member States of energy produced from renewable sources in other Member States, and to enable Member States to count energy from renewable sources consumed in other Member States towards their own renewable energy share. For that reason, the Commission should put in place a Union renewable development platform (\u2018URDP\u2019), enabling trading renewable energy shares between Member States, in addition to bilateral cooperation agreements. The URDP is intended to complement the voluntary opening of support schemes to projects located in other Member States. The agreements between Member States include statistical transfers, joint projects between Member States or joint support schemes. (39) Member States should be encouraged to pursue all appropriate forms of cooperation in relation to the objectives set out in this Directive and to inform citizens about the benefits stemming from the use of cooperation mechanisms. Such cooperation can take place at all levels, bilaterally or multilaterally. Apart from the mechanisms which have an effect on target renewable energy share calculation and target compliance, and which are exclusively provided for in this Directive, namely statistical transfers between Member States \u2013whether put in place bilaterally or through the URDP \u2013 joint projects and joint support schemes, cooperation can also take the form of, for example, exchanges of information and best practices, as provided for, in particular, in the e-platform established by Regulation (EU) 2018/1999, and other voluntary coordination between all types of support schemes. (40) It should be possible for imported electricity produced from renewable sources outside the Union to count towards Member States' renewable energy shares. In order to guarantee an adequate effect of renewable energy replacing non-renewable energy in the Union as well as in third countries, it is appropriate to ensure that such imports can be tracked and accounted for in a reliable way. Agreements with third countries concerning the organisation of such trade in renewable electricity will be considered. If, by virtue of a decision taken under the Energy Community Treaty (11) to that effect, the contracting parties thereto are bound by the relevant provisions of this Directive, the measures of cooperation between Member States provided for in this Directive should be applicable to them. (41) When Member States undertake joint projects with one or more third countries regarding the production of renewable electricity, it is appropriate that those joint projects relate only to newly constructed installations or to installations with newly increased capacity. This will help ensure that the proportion of energy from renewable sources in the third country's total energy consumption is not reduced due to the importation of energy from renewable sources into the Union. (42) In addition to establishing a Union framework for the promotion of energy from renewable sources, this Directive also contributes to the potential positive impact which the Union and the Member States can have in boosting the development of the renewable energy sector in third countries. The Union and the Member States should promote research, development and investment in the production of renewable energy in developing and other partner countries while fully respecting international law, thereby strengthening their environmental and economic sustainability and their export capacity of renewable energy. (43) The procedure used for the authorisation, certification and licensing of renewable energy plants should be objective, transparent, non-discriminatory and proportionate when applying the rules to specific projects. In particular, it is appropriate to avoid any unnecessary burden that could arise by classifying renewable energy projects under installations which represent a high risk to health. (44) For the benefit of the rapid deployment of energy from renewable sources and in view of their overall high sustainable and environmental beneficial quality, Member States should, when applying administrative rules or planning structures and legislation which are designed for licensing installations with respect to pollution reduction and control of industrial plants, for combating air pollution, or for the prevention or minimisation of the discharge of dangerous substances in the environment, take into account the contribution of energy from renewable sources towards meeting environmental and climate change objectives, in particular when compared to non-renewable energy installations. (45) The coherence between the objectives of this Directive and the Union's other environmental law should be ensured. In particular, during assessment, planning or licensing procedures for renewable energy installations, Member States should take account of all Union environmental law and the contribution made by energy from renewable sources towards meeting environmental and climate change objectives, in particular when compared to non-renewable energy installations. (46) Geothermal energy is an important local renewable energy source which usually has considerably lower emissions than fossil fuels, and certain types of geothermal plants produce near-zero emission. However, depending on the geological characteristics of an area, the production of geothermal energy may release greenhouse gases and other substances from underground fluids, and other subsoil geological formations, which are harmful for health and the environment. The Commission should therefore facilitate only the deployment of geothermal energy with a low environmental impact and resulting in greenhouse gas emissions savings compared to non-renewable sources. (47) At national, regional and where applicable local level, rules and obligations for minimum requirements for the use of energy from renewable sources in new and renovated buildings have led to considerable increases in the use of energy from renewable sources. Those measures should be encouraged in a wider Union context, while promoting the use of more energy-efficient applications of energy from renewable sources in combination with energy-savings and energy-efficiency measures through building regulations and codes. (48) In order to facilitate and accelerate the setting of minimum levels for the use of energy from renewable sources in buildings, the calculation of those minimum levels in new and existing buildings subject to major renovation should provide a sufficient basis for assessing whether the inclusion of minimum levels of renewable energy is technically, functionally and economically feasible. Member States should allow, inter alia, the use of efficient district heating and cooling or, where district heating and cooling systems are not available, other energy infrastructure to fulfil those requirements. (49) To ensure that national measures for developing renewable heating and cooling are based on comprehensive mapping and analysis of the national renewable and waste energy potential and that such measures provide for increased integration of renewable energy, by supporting, inter alia, innovative technologies such as heat pumps, geothermal and solar thermal technologies, and waste heat and cold, it is appropriate to require that Member States carry out an assessment of their potential of energy from renewable sources and the use of waste heat and cold in the heating and cooling sector, in particular to promote energy from renewable sources in heating and cooling installations and promote competitive and efficient district heating and cooling. To ensure consistency with energy efficiency requirements for heating and cooling and reduce administrative burden, that assessment should be included in the comprehensive assessments carried out and notified in accordance with Article 14 of Directive 2012/27/EU of the European Parliament and of the Council (12). (50) The lack of transparent rules and coordination between the different authorisation bodies has been shown to hinder the deployment of energy from renewable sources. Providing guidance to applicants throughout their administrative permit application and granting processes by means of an administrative contact point is intended to reduce complexity for project developers and increase efficiency and transparency, including for renewables self-consumers and renewable energy communities. Such guidance is to be provided at an appropriate level of governance, taking into account the specificities of Member States. The single contact points should guide the applicant and facilitate through the entire administrative process so that the applicant is not obliged to contact other administrative bodies in order to complete the permit-granting process, unless the applicant prefers to do so. (51) Lengthy administrative procedures constitute a major administrative barrier and are costly. The simplification of administrative permit granting processes, and clear time-limits for decisions to be taken by the authorities competent for issuing the authorisation for the electricity generation installation on the basis of a completed application, should stimulate a more efficient handling of procedures, thereby reducing administrative costs. A manual of procedures should be made available to facilitate the understanding of procedures for project developers and citizens wishing to invest in renewable energy. In order to foster the uptake of renewable energy by microenterprises and small and medium-sized enterprises (SMEs) and individual citizens, in accordance with the objectives set out in this Directive, a simple-notification procedure for grid connections to the competent body should be established for small renewable energy projects, including those that are decentralised, such as rooftop solar installations. In order to respond to the increasing need for the repowering of existing renewable energy plants, streamlined permit-granting procedures should be provided for. This Directive, in particular the provisions on the organisation and duration of the administrative permit granting process, should apply without prejudice to international and Union law, including provisions to protect the environment and human health. Where duly justified on the grounds of extraordinary circumstances, it should be possible to extend the initial timeframes by up to one year. (52) Information and training gaps, especially in the heating and cooling sector, should be removed in order to encourage the deployment of energy from renewable sources. (53) In so far as the access or pursuit of the profession of installer is a regulated profession, the preconditions for the recognition of professional qualifications are laid down in Directive 2005/36/EC of the European Parliament and of the Council (13). This Directive therefore applies without prejudice to Directive 2005/36/EC. (54) While Directive 2005/36/EC lays down requirements for the mutual recognition of professional qualifications, including for architects, there is also a need to ensure that planners and architects properly consider an optimal combination of renewable energy and high-efficiency technologies in their plans and designs. Member States should therefore provide clear guidance in that regard. This should be done without prejudice to that Directive and in particular Articles 46 and 49 thereof. (55) Guarantees of origin issued for the purposes of this Directive have the sole function of showing to a final customer that a given share or quantity of energy was produced from renewable sources. A guarantee of origin can be transferred, independently of the energy to which it relates, from one holder to another. However, with a view to ensuring that a unit of renewable energy is disclosed to a customer only once, double counting and double disclosure of guarantees of origin should be avoided. Energy from renewable sources in relation to which the accompanying guarantee of origin has been sold separately by the producer should not be disclosed or sold to the final customer as energy from renewable sources. It is important to distinguish between green certificates used for support schemes and guarantees of origin. (56) It is appropriate to allow the consumer market for renewable electricity to contribute to the development of energy from renewable sources. Member States should therefore require electricity suppliers who disclose their energy mix to final customers pursuant to Union law on the internal market for electricity, or who market energy to consumers with a reference to the consumption of energy from renewable sources, to use guarantees of origin from installations producing energy from renewable sources. (57) It is important to provide information on how supported electricity is allocated to final customers. In order to improve the quality of that information to consumers, Member States should ensure that guarantees of origin are issued for all units of renewable energy produced, except where they decide not to issue guarantees of origin to producers that also receive financial support. If Member States decide to issue guarantees of origin to producers that also receive financial support or not to issue guarantees of origin directly to producers, they should be able to choose by which means and mechanisms to take into account the market value of those guarantees of origin. Where renewable energy producers also receive financial support, the market value of the guarantees of origin for the same production should be appropriately taken into account in the relevant support scheme. (58) Directive 2012/27/EU provides for guarantees of origin for proving the origin of electricity produced from high-efficiency cogeneration plants. However, no use is specified for such guarantees of origin, so their use may also be enabled when disclosing the use of energy from high-efficiency cogeneration. (59) Guarantees of origin which are currently in place for renewable electricity should be extended to cover renewable gas. Extending the guarantees of origin system to energy from non-renewable sources should be an option for Member States. This would provide a consistent means of proving to final customers the origin of renewable gas such as biomethane and would facilitate greater cross-border trade in such gas. It would also enable the creation of guarantees of origin for other renewable gas such as hydrogen. (60) There is a need to support the integration of energy from renewable sources into the transmission and distribution grid and the use of energy storage systems for integrated variable production of energy from renewable sources, in particular as regards the rules regulating dispatch and access to the grid. The framework for the integration of renewable electricity is provided for in other Union law relating to the internal electricity market. However, that framework does not include provisions on the integration of gas from renewable sources into the gas grid. It is therefore necessary to include such provisions in this Directive. (61) The opportunities for establishing economic growth through innovation and a sustainable competitive energy policy have been recognised. Production of energy from renewable sources often depends on local or regional SMEs. The opportunities for local business development, sustainable growth and high-quality employment that investments in regional and local production of energy from renewable sources bring about in the Member States and their regions are important. The Commission and the Member States should therefore foster and support national and regional development measures in those areas, encourage the exchange of best practices in production of energy from renewable sources between local and regional development initiatives and enhance the provision of technical assistance and training programmes, in order to strengthen regulatory, technical and financial expertise and foster knowledge on available funding possibilities, including a more targeted use of Union funds, such as the use of cohesion policy funding in that area. (62) Regional and local authorities often set more ambitious renewable targets that exceed national targets. Regional and local commitments to stimulating development of renewable energy and energy efficiency are currently supported through networks, such as the Covenant of Mayors, Smart Cities or Smart Communities initiatives, and the development of sustainable energy action plans. Such networks are essential and should be expanded, as they raise awareness and facilitate exchanges of best practices and available financial support. In that context, the Commission should support interested innovative regions and local authorities to work across borders by assisting in setting up cooperation mechanisms, such as the European Grouping of Territorial Cooperation, which enables public authorities of various Member States to collaborate and deliver joint services and projects, without requiring a prior international agreement to be signed and ratified by national parliaments. Other innovative measures to attract more investment into new technologies, such as energy-performance contracts and standardisation processes in public financing, should also be considered. (63) When favouring the development of the market for energy from renewable sources, it is necessary to take into account the positive impact on regional and local development opportunities, export prospects, social cohesion and employment opportunities, in particular as concerns SMEs and independent energy producers, including renewables self-consumers and renewable energy communities. (64) The specific situation of the outermost regions is recognised in Article 349 TFEU. The energy sector in the outermost regions is often characterised by isolation, limited supply and dependence on fossil fuels while those regions benefit from significant local renewable sources of energy. The outermost regions could thus serve as examples of the application of innovative energy technologies for the Union. It is therefore necessary to promote the uptake of renewable energy in order to achieve a higher degree of energy autonomy for those regions and recognise their specific situation in terms of renewable energy potential and public support needs. Provision should be made for a derogation of limited local impact that allows Member States to adopt specific criteria in order to ensure eligibility for financial support for the consumption of certain biomass fuels. Member States should be able to adopt such specific criteria for installations using biomass fuels and located in an outermost region as referred to in Article 349 TFEU, as well as for biomass that is used as fuel in such installations and that does not comply with the harmonised sustainability, energy efficiency and greenhouse gas emissions saving criteria set out in this Directive. Such specific criteria for biomass fuels should apply irrespective of whether the place of origin of that biomass is a Member State or a third country. Moreover, any specific criteria should be objectively justified on the grounds of energy independence of the outermost region concerned and of ensuring a smooth transition to the sustainability criteria, the energy efficiency criteria and the greenhouse gas emissions saving criteria for biomass fuels of this Directive in such an outermost region. Considering that the energy mix for electricity generation for the outermost regions is made up to a large extent of fuel oil, it is necessary to allow an appropriate consideration of greenhouse gas emissions saving criteria in those regions. It would therefore be appropriate to provide for a specific fossil fuel comparator for the electricity produced in the outermost regions. Member States should ensure effective compliance with their specific criteria. Finally, Member States should, without prejudice to support granted in accordance with support schemes in accordance with this Directive, not refuse to take into account, on other sustainability grounds, biofuels and bioliquids obtained in accordance with this Directive. This prohibition is intended to ensure that biofuels and bioliquids that comply with the harmonised criteria provided for in this Directive continue to benefit from the trade facilitation objectives of this Directive, including as regards the outermost regions concerned. (65) It is appropriate to allow for the development of decentralised renewable energy technologies and storage under non-discriminatory conditions and without hampering the financing of infrastructure investments. The move towards decentralised energy production has many benefits, including the utilisation of local energy sources, increased local security of energy supply, shorter transport distances and reduced energy transmission losses. Such decentralisation also fosters community development and cohesion by providing income sources and creating jobs locally. (66) With the growing importance of self-consumption of renewable electricity, there is a need for a definition of \u2018renewables self-consumers\u2019 and of \u2018jointly acting renewables self-consumers\u2019. It is also necessary to establish a regulatory framework which would empower renewables self-consumers to generate, consume, store, and sell electricity without facing disproportionate burdens. Citizens living in apartments for example should be able to benefit from consumer empowerment to the same extent as households in single family homes. However, Member States should be allowed to differentiate between individual renewables self-consumers and jointly acting renewables self-consumers due to their different characteristics to the extent that any such differentiation is proportionate and duly justified. (67) Empowering jointly acting renewables self-consumers also provides opportunities for renewable energy communities to advance energy efficiency at household level and helps fight energy poverty through reduced consumption and lower supply tariffs. Member States should take appropriate advantage of that opportunity by, inter alia, assessing the possibility to enable participation by households that might otherwise not be able to participate, including vulnerable consumers and tenants. (68) Renewables self-consumers should not face discriminatory or disproportionate burdens or costs and should not be subject to unjustified charges. Their contribution to the achievement of the climate and energy target and the costs and benefits that they bring about in the wider energy system should be taken into account. Member States should therefore generally not apply charges to electricity produced and consumed within the same premises by renewables self-consumers. However, Member States should be allowed to apply non-discriminatory and proportionate charges to such electricity if necessary to ensure the financial sustainability of the electricity system, to limit the support to what is objectively needed and to make efficient use of their support schemes. At the same time, Member States should ensure that renewables self-consumers contribute in a balanced and adequate way to the overall cost-sharing system of producing, distributing and consuming electricity, when electricity is fed into the grid. (69) To that end, Member States should as a general principle not apply charges to electricity individually produced and consumed by renewables self-consumers within the same premises. However, in order to prevent that incentive from affecting the financial stability of support schemes for renewable energy, that incentive could be limited to small installations with an electrical capacity of 30 kW or less. In certain cases, Member States should be allowed to apply charges to renewables self-consumers for self-consumed electricity, where they make efficient use of their support schemes and apply non-discriminatory and effective access to their support schemes. Member States should also be able to apply partial exemptions from charges, levies, or a combination thereof and support, up to the level needed to ensure the economic viability of such projects. (70) The participation of local citizens and local authorities in renewable energy projects through renewable energy communities has resulted in substantial added value in terms of local acceptance of renewable energy and access to additional private capital which results in local investment, more choice for consumers and greater participation by citizens in the energy transition. Such local involvement is all the more crucial in a context of increasing renewable energy capacity. Measures to allow renewable energy communities to compete on an equal footing with other producers also aim to increase the participation of local citizens in renewable energy projects and therefore increase acceptance of renewable energy. (71) The specific characteristics of local renewable energy communities in terms of size, ownership structure and the number of projects can hamper their competition on an equal footing with large-scale players, namely competitors with larger projects or portfolios. Therefore, it should be possible for Member States to choose any form of entity for renewable energy communities, provided that such an entity may, acting in its own name, exercise rights and be subject to obligations. To avoid abuse and to ensure broad participation, renewable energy communities should be capable of remaining autonomous from individual members and other traditional market actors that participate in the community as members or shareholders, or who cooperate through other means such as investment. Participation in renewable energy projects should be open to all potential local members based on objective, transparent and non-discriminatory criteria. Measures to offset the disadvantages relating to the specific characteristics of local renewable energy communities in terms of size, ownership structure and the number of projects include enabling renewable energy communities to operate in the energy system and easing their market integration. Renewable energy communities should be able to share between themselves energy that is produced by their community-owned installations. However, community members should not be exempt from relevant costs, charges, levies and taxes that would be borne by final consumers who are not community members, producers in a similar situation, or where public grid infrastructure is used for those transfers. (72) Household consumers and communities engaging in renewables self-consumption should maintain their rights as consumers, including the rights to have a contract with a supplier of their choice and to switch supplier. (73) Representing around half of the final energy consumption of the Union, the heating and cooling sector is considered to be a key sector in accelerating the decarbonisation of the energy system. Moreover, it is also a strategic sector in terms of energy security, as around 40 % of the renewable energy consumption by 2030 is projected to come from renewable heating and cooling. However, the absence of a harmonised strategy at Union level, the lack of internalisation of external costs and the fragmentation of heating and cooling markets have, to date, led to relatively slow progress in the sector. (74) Several Member States have implemented measures in the heating and cooling sector to reach their 2020 renewable energy target. However, in the absence of binding national targets post-2020, the remaining national incentives may not be sufficient to reach the long-term decarbonisation goals for 2030 and 2050. In order to meet such goals, reinforce investor certainty and foster the development of a Union-wide renewable heating and cooling market, while respecting the energy efficiency first principle, it is appropriate to encourage the efforts of Member States in the supply of renewable heating and cooling to contribute to the progressive increase of the share of renewable energy. Given the fragmented nature of some heating and cooling markets, it is of utmost importance to ensure flexibility in designing such an effort. It is also important to ensure that a potential uptake of renewable heating and cooling does not have detrimental environmental side-effects or lead to disproportionate overall costs. In order to minimise that risk, the increase of the share of renewable energy in the heating and cooling sector should take into account the situation of those Member States where the share is already very high, or where waste heat and cold is not used, such as in Cyprus and Malta. (75) District heating and cooling currently represents around 10 % of the heat demand across the Union, with large discrepancies between Member States. The Commission's heating and cooling strategy has recognised the potential for decarbonisation of district heating through increased energy efficiency and renewable energy deployment. (76) The Energy Union strategy also recognised the role of the citizen in the energy transition, where citizens take ownership of the energy transition, benefit from new technologies to reduce their bills, and participate actively in the market. (77) The potential synergies between an effort to increase the uptake of renewable heating and cooling and the existing schemes under Directive 2010/31/EU of the European Parliament and of the Council (14) and Directive 2012/27/EU should be emphasised. Member States should, to the extent possible, have the possibility to use existing administrative structures to implement such effort, in order to mitigate the administrative burden. (78) In the area of district heating, it is therefore crucial to enable the fuel-switching to energy from renewable sources and prevent regulatory and technology lock-in and technology lock-out through reinforced rights for renewable energy producers and final consumers, and bring the tools to final consumers to facilitate their choice between the highest energy-performance solutions that take into account future heating and cooling needs in accordance with expected building performance criteria. Final consumers should be given transparent and reliable information on the efficiency of district heating and cooling systems and the share of energy from renewable sources in their specific heating or cooling supply. (79) In order to protect consumers of district heating and cooling systems that are not efficient district heating and cooling systems and to allow them to produce their heating or cooling from renewable sources and with significantly better energy performance, consumers should be entitled to disconnect and thus discontinue the heating or cooling service from non-efficient district heating and cooling systems at a whole building level by terminating their contract or, where the contract covers several buildings, by modifying the contract with the district heating or cooling operator. (80) To prepare for the transition towards advanced biofuels and minimise the overall direct and indirect land-use change impacts, it is appropriate to limit the amount of biofuels and bioliquids produced from cereal and other starch-rich crops, sugars and oil crops that can be counted towards the targets laid down in this Directive, without restricting the overall possibility of using such biofuels and bioliquids. The establishment of a limit at Union level should not prevent Member States from providing for lower limits to the amount of biofuels and bioliquids produced from cereal and other starch-rich crops, sugars and oil crops that can be counted at national level towards the targets laid down in this Directive, without restricting the overall possibility of using such biofuels and bioliquids. (81) Directive 2009/28/EC introduced a set of sustainability criteria, including criteria protecting land with high biodiversity value and land with high-carbon stock, but did not cover the issue of indirect land-use change. Indirect land-use change occurs when the cultivation of crops for biofuels, bioliquids and biomass fuels displaces traditional production of crops for food and feed purposes. Such additional demand increases the pressure on land and can lead to the extension of agricultural land into areas with high-carbon stock, such as forests, wetlands and peatland, causing additional greenhouse gas emissions. Directive (EU) 2015/1513 of the European Parliament and of the Council (15) recognises that the magnitude of greenhouse gas emissions-linked indirect land-use change is capable of negating some or all greenhouse gas emissions savings of individual biofuels, bioliquids or biomass fuels. While there are risks arising from indirect land-use change, research has shown that the scale of the effect depends on a variety of factors, including the type of feedstock used for fuel production, the level of additional demand for feedstock triggered by the use of biofuels, bioliquids and biomass fuels, and the extent to which land with high-carbon stock is protected worldwide. While the level of greenhouse gas emissions caused by indirect land-use change cannot be unequivocally determined with the level of precision required to be included in the greenhouse gas emission calculation methodology, the highest risks of indirect land-use change have been identified for biofuels, bioliquids and biomass fuels produced from feedstock for which a significant expansion of the production area into land with high-carbon stock is observed. It is therefore appropriate, in general, to limit food and feed crops-based biofuels, bioliquids and biomass fuels promoted under this Directive and, in addition, to require Member States to set a specific and gradually decreasing limit for biofuels, bioliquids and biomass fuels produced from food and feed crops for which a significant expansion of the production area into land with high-carbon stock is observed. Low indirect land-use change-risk biofuels, bioliquids and biomass fuels should be exempt from the specific and gradually decreasing limit. (82) Yield increases in agricultural sectors by means of improved agricultural practices, investments in better machinery and knowledge transfer, beyond levels which would have prevailed in the absence of productivity-promoting schemes for food and feed crop-based biofuels, bioliquids and biomass fuels, as well as the cultivation of crops on land not previously used for the cultivation of crops, can mitigate indirect land-use change. Where there is evidence that such measures have led to an increase of production going beyond the expected increase in productivity, biofuels, bioliquids and biomass fuels produced from such additional feedstock should be considered to be low indirect land-use change-risk biofuels, bioliquids and biomass fuels. Annual yield fluctuations should be taken into account in that context. (83) Directive (EU) 2015/1513 called on the Commission to submit, without delay, a comprehensive proposal for a cost-effective and technology-neutral post-2020 policy in order to create a long-term perspective for investment in sustainable biofuels with a low risk of causing indirect land-use change with a headline target of decarbonising the transport sector. An obligation on Member States to require fuel suppliers to deliver an overall share of fuels from renewable sources can provide certainty for investors and encourage the continuous development of alternative renewable transport fuels including advanced biofuels, renewable liquid and gaseous transport fuels of non-biological origin, and renewable electricity in the transport sector. Since renewable alternatives might not be available or cost-efficient to all fuel suppliers, it is appropriate to allow Member States to distinguish between fuel suppliers and to exempt, if necessary, particular types of fuel supplier from the obligation. As transport fuels are traded easily, fuel suppliers in Member States with low supplies of the relevant resources are likely easily to obtain renewable fuels from other sources. (84) A Union database should be put in place to ensure transparency and traceability of renewable fuels. While Member States should be allowed to continue to use or establish national databases, those national databases should be linked to the Union database, in order to ensure instant data transfers and harmonisation of data flows. (85) Advanced biofuels and other biofuels and biogas produced from feedstock listed in an annex to this Directive, renewable liquid and gaseous transport fuels of non-biological origin, and renewable electricity in the transport sector can contribute to low carbon emissions, stimulating the decarbonisation of the Union transport sector in a cost-effective manner, and improving, inter alia, energy diversification in the transport sector while promoting innovation, growth and jobs in the Union economy and reducing reliance on energy imports. An obligation on Member States to require fuel suppliers to ensure a minimum share of advanced biofuels and certain biogases, is intended to encourage continuous development of advanced fuels, including biofuels. It is important to ensure that that obligation also promotes improvements in the greenhouse gas performance of the fuels supplied to meet it. The Commission should assess the greenhouse gas performance, technical innovation and sustainability of those fuels. (86) With regard to Intelligent Transport, it is important to increase the development and deployment of electric mobility for road, as well as to accelerate the integration of advanced technologies into innovative rail. (87) Electromobility is expected to constitute a substantial part of the renewable energy in the transport sector by the year 2030. Further incentives should be provided considering the swift development of electromobility and the potential of that sector in terms of growth and jobs in the Union. Multipliers for renewable electricity supplied for the transport sector should be used for the promotion of renewable electricity in the transport sector and in order to reduce the comparative disadvantage in energy statistics. Since it is not possible to account for all electricity supplied for road vehicles in statistics through dedicated metering, such as charging at home, multipliers should be used in order to ensure that the positive impacts of electrified renewable energy-based transport are properly accounted for. Options should be explored to ensure that the new demand for electricity in the transport sector is met with additional generation capacity of energy from renewable sources. (88) In light of climatic constraints that limit the possibility of consuming certain types of biofuels due to environmental, technical or health concerns, and due to the size and structure of their fuel markets, it is appropriate that Cyprus and Malta, for the purposes of demonstrating compliance with national renewable energy obligations placed on fuel suppliers, be allowed to take into account those inherent limitations. (89) The promotion of recycled carbon fuels can contribute towards the policy objectives of energy diversification and decarbonisation of the transport sector where they fulfil the appropriate minimum greenhouse gas emissions savings threshold. It is therefore appropriate to include those fuels in the obligation on fuel supplier, whilst giving Member States the option not to consider those fuels in the obligation if they do not wish to do so. Since those fuels are not renewable, they should not be counted towards the overall Union target for energy from renewable sources. (90) Renewable liquid and gaseous transport fuels of non-biological origin are important to increase the share of renewable energy in sectors that are expected to rely on liquid fuels in the long term. To ensure that renewable fuels of non-biological origin contribute to greenhouse gas reduction, the electricity used for the fuel production should be of renewable origin. The Commission should develop, by means of delegated acts, a reliable Union methodology to be applied where such electricity is taken from the grid. That methodology should ensure that there is a temporal and geographical correlation between the electricity production unit with which the producer has a bilateral renewables power purchase agreement and the fuel production. For example, renewable fuels of non-biological origin cannot be counted as fully renewable if they are produced when the contracted renewable generation unit is not generating electricity. Another example is the case of electricity grid congestion, where fuels can be counted as fully renewable only when both the electricity generation and the fuel production plants are located on the same side in respect of the congestion. Furthermore, there should be an element of additionality, meaning that the fuel producer is adding to the renewable deployment or to the financing of renewable energy. (91) Feedstock which has low indirect land-use change impacts when used for biofuels, should be promoted for its contribution to the decarbonisation of the economy. Feedstock for advanced biofuels and biogas for transport, for which technology is more innovative and less mature and therefore needs a higher level of support, should, in particular, be included in an annex to this Directive. In order to ensure that it is updated in accordance with the latest technological developments while avoiding unintended negative effects, the Commission should review that annex in order to assess whether new feedstock should be added. (92) The costs of connecting new producers of gas from renewable sources to the gas grids should be based on objective, transparent and non-discriminatory criteria and due account should be taken of the benefit that embedded local producers of gas from renewable sources bring to the gas grids. (93) In order to exploit the full potential of biomass, which does not include peat or material embedded in geological formations and/or transformed to fossil, to contribute to the decarbonisation of the economy through its uses for materials and energy, the Union and the Member States should promote greater sustainable mobilisation of existing timber and agricultural resources and the development of new forestry and agriculture production systems, provided that sustainability and greenhouse gas emissions saving criteria are met. (94) Biofuels, bioliquids and biomass fuels should always be produced in a sustainable manner. Biofuels, bioliquids and biomass fuels used for compliance with the Union target laid down in this Directive, and those which benefit from support schemes, should therefore be required to fulfil sustainability and greenhouse gas emissions saving criteria. The harmonisation of those criteria for biofuels and bioliquids is essential for the achievement of the energy policy objectives of the Union as set out in Article 194(1) TFEU. Such harmonisation ensures the functioning of the internal energy market and thus facilitates, especially with regard to the obligation of Member States not to refuse to take into account, on other sustainability grounds, biofuels and bioliquids obtained in accordance with this Directive, trade between Member States in compliant biofuels and bioliquids. The positive effects of the harmonisation of those criteria on the smooth functioning of the internal energy market and on the avoidance of distortion of competition in the Union cannot be frustrated. For biomass fuels, Member States should be allowed to establish additional sustainability and greenhouse gas emissions saving criteria. (95) The Union should take appropriate steps in the context of this Directive, including the promotion of sustainability and greenhouse gas emissions saving criteria for biofuels, and for bioliquids and biomass fuels. (96) The production of agricultural raw material for biofuels, bioliquids and biomass fuels, and the incentives provided for in this Directive to promote their use, should not have the effect of encouraging the destruction of biodiverse lands. Such finite resources, recognised in various international instruments to be of universal value, should be preserved. It is therefore necessary to provide sustainability and greenhouse gas emissions saving criteria ensuring that biofuels, bioliquids and biomass fuels qualify for the incentives only where it is guaranteed that agricultural raw material does not originate from biodiverse areas or, in the case of areas designated for nature protection purposes or for the protection of rare, threatened or endangered ecosystems or species, the relevant competent authority demonstrates that the production of the agricultural raw material does not interfere with such purposes. (97) Forests should be considered to be biodiverse in accordance with the sustainability criteria where they are primary forests in accordance with the definition used by the Food and Agriculture Organisation of the United Nations (FAO) in its Global Forest Resource Assessment, or where they are protected by national nature protection law. Areas where the collection of non-wood forest products occurs should be considered to be biodiverse forests, provided that the human impact is small. Other types of forest as defined by the FAO, such as modified natural forests, semi-natural forests and plantations, should not be considered to be primary forests. Having regard, furthermore, to the highly biodiverse nature of certain grasslands, both temperate and tropical, including highly biodiverse savannahs, steppes, scrublands and prairies, biofuels, bioliquids and biomass fuels made from agricultural raw materials originating in such lands should not qualify for the incentives provided for by this Directive. In order to establish appropriate criteria to define such highly biodiverse grassland in accordance with the best available scientific data and relevant international standards, implementing powers should be conferred on the Commission. (98) Land should not be converted to accommodate the production of agricultural raw material for biofuels, bioliquids and biomass fuels if its carbon stock loss upon conversion could not, within a reasonable period, taking into account the urgency of tackling climate change, be compensated for by the greenhouse gas emission savings resulting from the production and use of biofuels, bioliquids and biomass fuels. This would prevent unnecessary, burdensome research by economic operators and the conversion of high-carbon-stock land that are demonstrated to be ineligible for producing agricultural raw materials for biofuels bioliquids and biomass fuels. Inventories of worldwide carbon stocks indicate that wetlands and continuously forested areas with a canopy cover of more than 30 % should be included in that category. (99) In the framework of the Common Agricultural Policy, Union farmers should comply with a comprehensive set of environmental requirements in order to receive direct support. Compliance with those requirements can be most effectively verified in the context of agricultural policy. Including those requirements in the sustainability scheme is not appropriate as the sustainability criteria for bioenergy should set out rules that are objective and apply globally. Verification of compliance under this Directive would also risk causing an unnecessary administrative burden. (100) Agricultural feedstock for the production of biofuels, bioliquids and biomass fuels should be produced using practices that are consistent with the protection of soil quality and soil organic carbon. Soil quality and soil carbon should therefore be included in monitoring systems of operators or national authorities. (101) It is appropriate to introduce Union-wide sustainability and greenhouse gas emissions saving criteria for biomass fuels used in the electricity sector and in the heating and cooling sector, in order to continue to ensure high greenhouse gas emissions savings compared to fossil fuel alternatives, to avoid unintended sustainability impacts, and to promote the internal market. The outermost regions should be able to use the potential of their resources in order to increase the production of renewable energy and their energy independence. (102) To ensure that, despite the growing demand for forest biomass, harvesting is carried out in a sustainable manner in forests where regeneration is ensured, that special attention is given to areas explicitly designated for the protection of biodiversity, landscapes and specific natural elements, that biodiversity resources are preserved and that carbon stocks are tracked, woody raw material should emanate only from forests that are harvested in accordance with the principles of sustainable forest management that are developed under international forest processes such as Forest Europe and that are implemented through national law or the best management practices at sourcing area level. Operators should take the appropriate steps in order to minimise the risk of using unsustainable forest biomass for the production of bioenergy. To that end, operators should put in place a risk-based approach. In this context, it is appropriate for the Commission to develop operational guidance on the verification of compliance with the risk-based approach by means of implementing acts, after consulting the Committee on the Sustainability of Biofuels, Bioliquids and Biomass fuels. (103) Harvesting for energy purposes has increased and is expected to continue to grow, resulting in higher imports of raw materials from third countries as well as an increase of the production of those materials within the Union. It should be ensured that harvesting is sustainable. (104) In order to minimise the administrative burden, the Union sustainability and greenhouse gas emissions saving criteria should apply only to electricity and heating from biomass fuels produced in installations with a total rated thermal input equal to or exceeding 20 MW. (105) Biomass fuels should be converted into electricity and heat in an efficient way in order to maximise energy security and greenhouse gas emissions savings, as well as to limit emissions of air pollutants and minimise the pressure on limited biomass resources. (106) The minimum greenhouse gas emissions savings threshold for biofuels, bioliquids and biogas for transport produced in new installations should be increased in order to improve their overall greenhouse gas balance and to discourage further investments in installations with a low greenhouse gas emission savings performance. That increase provides investment safeguards for biofuels, bioliquids and biogas for transport production capacity. (107) Based on experience in the practical implementation of the Union sustainability criteria, it is appropriate to strengthen the role of voluntary international and national certification schemes for verification of compliance with the sustainability criteria in a harmonised manner. (108) It is in the interests of the Union to encourage the development of voluntary international or national schemes that set standards for the production of sustainable biofuels, bioliquids and biomass fuels and that certify that the production of biofuels, bioliquids and biomass fuels meets those standards. For that reason, provision should be made for schemes to be recognised as providing reliable evidence and data where they meet adequate standards of reliability, transparency and independent auditing. In order to ensure that compliance with the sustainability and greenhouse gas emissions saving criteria is verified in a robust and harmonised manner and in particular to prevent fraud, the Commission should be empowered to adopt detailed implementing rules, including adequate standards of reliability, transparency and independent auditing to be applied by the voluntary schemes. (109) Voluntary schemes play an increasingly important role in providing evidence of compliance with the sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids and biomass fuels. It is therefore appropriate for the Commission to require voluntary schemes, including those already recognised by the Commission, to report regularly on their activity. Such reports should be made public in order to increase transparency and to improve supervision by the Commission. Furthermore, such reporting would provide the necessary information for the Commission to report on the operation of the voluntary schemes with a view to identifying best practices and submitting, if appropriate, a proposal to further promote such best practices. (110) To facilitate the functioning of the internal market, evidence regarding the sustainability and greenhouse gas emissions criteria for biofuels, bioliquids and biomass fuels that have been obtained in accordance with a scheme that has been recognised by the Commission should be accepted in all Member States. Member States should contribute towards ensuring the correct implementation of the certification principles of voluntary schemes by supervising the operation of certification bodies that are accredited by the national accreditation body and by informing the voluntary schemes about relevant observations. (111) In order to avoid a disproportionate administrative burden, a list of default values should be laid down for common biofuel, bioliquid and biomass fuel production pathways and that list should be updated and expanded when further reliable data are available. Economic operators should always be entitled to claim the level of greenhouse gas emissions savings for biofuels, bioliquids and biomass fuels established by that list. Where the default value for greenhouse gas emissions savings from a production pathway lies below the required minimum level of greenhouse gas emissions savings, producers wishing to demonstrate their compliance with that minimum level should be required to show that the actual greenhouse gas emissions from their production process are lower than those that were assumed when calculating the default values. (112) It is necessary to lay down clear rules based on objective and non-discriminatory criteria, for the calculation of greenhouse gas emissions savings from biofuels, bioliquids and biomass fuels and their fossil fuel comparators. (113) In accordance with current technical and scientific knowledge, the greenhouse gas emissions accounting methodology should take into account the transformation of solid and gaseous biomass fuels into final energy in order to be consistent with the calculation of renewable energy for the purposes of counting towards the Union target laid down in this Directive. The allocation of greenhouse gas emissions to co-products, as distinct from wastes and residues, should also be reviewed in cases where electricity or heating and cooling are produced in co-generation or multi-generation plants. (114) If land with high stocks of carbon in its soil or in its vegetation is converted for the cultivation of raw materials for biofuels, bioliquids and biomass fuels, some of the stored carbon will generally be released into the atmosphere, leading to the formation of carbon dioxide (CO2). The resulting negative greenhouse gas impact can offset the positive greenhouse gas impact of the biofuels, bioliquids or biomass fuels, in some cases by a wide margin. The full carbon effects of such conversion should therefore be taken into account in calculating the greenhouse gas emissions savings of particular biofuels, bioliquids and biomass fuels. This is necessary to ensure that the greenhouse gas emissions saving calculation takes into account the totality of the carbon effects of the use of biofuels, bioliquids and biomass fuels. (115) In calculating the greenhouse gas impact of land conversion, economic operators should be able to use actual values for the carbon stocks associated with the reference land use and the land use after conversion. They should also be able to use standard values. The methodology of the Intergovernmental Panel on Climate Change (IPCC) is the appropriate basis for such standard values. That work is not currently expressed in a form that is immediately applicable by economic operators. The Commission should therefore revise its guidelines of 10 June 2010 for the calculation of land carbon stocks for the purposes of the rules for calculating the greenhouse gas impact of biofuels, bioliquids and their fossil fuel comparators, which are set out in an annex to this Directive, while ensuring consistency with Regulation (EU) No 525/2013 of the European Parliament and of the Council (16). (116) Co-products from the production and use of fuels should be taken into account in the calculation of greenhouse gas emissions. The substitution method is appropriate for the purposes of policy analysis, but not for the regulation of individual economic operators and individual consignments of transport fuels. In those cases, the energy allocation method is the most appropriate method, as it is easy to apply, is predictable over time, minimises counter-productive incentives and produces results that are generally comparable with those produced by the substitution method. For the purposes of policy analysis, the Commission should also, in its reporting, present results using the substitution method. (117) Co-products are different from residues and agricultural residues, as they are the primary aim of the production process. It is therefore appropriate to clarify that agricultural crop residues are residues and not co-products. This has no implications on the existing methodology but clarifies the existing provisions. (118) The established method of using energy allocation as a rule for dividing greenhouse gas emissions between co-products has worked well and should be continued. It is appropriate to align the methodology for calculating greenhouse gas emissions coming from the use of combined heat and power (CHP) when the CHP is used in processing biofuels, bioliquids and biomass fuels to the methodology applied to a CHP being the end-use. (119) The methodology takes into account the reduced greenhouse gas emissions arising from the use of CHP, compared to the use of electricity plants and heat-only plants, by taking into account the utility of heat compared to electricity, and the utility of heat at different temperatures. It follows that higher temperature should bear a larger part of the total greenhouse gas emissions than heat at low temperature, when the heat is co-produced with electricity. The methodology takes into account the whole pathway to final energy, including conversion to heat or electricity. (120) It is appropriate for the data used in the calculation of the default values to be obtained from independent, scientifically expert sources and to be updated as appropriate as those sources progress their work. The Commission should encourage those sources to address, when they update their work, emissions from cultivation, the effects of regional and climatological conditions, the effects of cultivation using sustainable agricultural and organic farming methods, and the scientific contributions of producers in the Union and in third countries, and civil society. (121) Global demand for agricultural commodities is growing. Part of that increase in demand is likely to be met through an increase in the amount of land devoted to agriculture. The restoration of land that has been severely degraded and therefore cannot otherwise be used for agricultural purposes is a way of increasing the amount of land available for cultivation. The sustainability scheme should promote the use of such restored land because the promotion of biofuels, bioliquids and biomass fuels will contribute to the growth in demand for agricultural commodities. (122) In order to ensure the harmonised implementation of the greenhouse gas emissions calculation methodology and to align to the latest scientific evidence, implementing powers should be conferred on the Commission to adapt the methodological principles and values necessary for assessing whether greenhouse gas emissions saving criteria have been fulfilled and to assess whether reports submitted by Member States and third countries contain accurate data on cultivation emissions of feedstock. (123) European gas grids are becoming more integrated. The promotion of the production and use of biomethane, its injection into a natural gas grid and cross-border trade create a need to ensure proper accounting of renewable energy as well as avoiding double incentives resulting from support schemes in different Member States. The mass balance system related to verification of bioenergy sustainability and the new Union database are intended to help address those issues. (124) The achievement of the objectives of this Directive requires that the Union and Member States dedicate a significant amount of financial resources to research and development in relation to renewable energy technologies. In particular, the European Institute of Innovation and Technology should give high priority to the research and development of renewable energy technologies. (125) The implementation of this Directive should, where relevant, reflect the Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, in particular as implemented through Directive 2003/4/EC of the European Parliament and of the Council (17). (126) In order to amend or supplement non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of establishing the methodology for calculating the quantity of renewable energy used for cooling and district cooling and amending the methodology for calculating energy from heat pumps; establishing the URDP and setting the conditions for finalising transactions of statistical transfer between Member States via the URDP; establishing appropriate minimum thresholds for greenhouse gas emissions savings of recycled carbon fuels; adopting, and if appropriate amending, the criteria for certification of low indirect land-use change-risk biofuels, bioliquids and biomass fuels and for determining the high indirect land-use change-risk feedstock for which significant expansion of the production into land with high-carbon stock is observed and the gradual decrease in their contribution to the targets laid down in this Directive; adapting the energy content of transport fuels to scientific and technical progress; establishing the Union methodology for setting the rules by which economic operators are to comply with the requirements for counting electricity as fully renewable when used for the production of renewable liquid and gaseous transport fuels of non-biological origin or when taken from the grid; specifying the methodology by which to determine the share of biofuel, and biogas for transport, resulting from biomass being processed with fossil fuels in a common process and the methodology by which to assess the greenhouse gas emissions savings from renewable liquid and gaseous transport fuels of non-biological origin and from recycled carbon fuels in order to ensure that credits from greenhouse gas emissions savings are given only once; amending by adding to, but not removing from, the lists of feedstock for the production of advanced biofuels and other biofuels and biogas; and supplementing or amending the rules for calculating the greenhouse gas impact of biofuels, bioliquids and their fossil fuel comparators. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (18). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (127) The measures necessary for the implementation of this Directive should be adopted in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (19). (128) Since the objective of this Directive, namely to achieve a share of at least 32 % of energy from renewable sources in the Union's gross final consumption of energy by 2030, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (129) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (20), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (130) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to Directive 2009/28/EC. The obligation to transpose provisions which are unchanged arises under that Directive. (131) This Directive should be without prejudice to the obligations of the Member States relating to the time-limit for the transposition into national law of Council Directive 2013/18/EU (21) and Directive (EU) 2015/1513, HAVE ADOPTED THIS DIRECTIVE: Article 1 Subject matter This Directive establishes a common framework for the promotion of energy from renewable sources. It sets a binding Union target for the overall share of energy from renewable sources in the Union's gross final consumption of energy in 2030. It also lays down rules on financial support for electricity from renewable sources, on self-consumption of such electricity, on the use of energy from renewable sources in the heating and cooling sector and in the transport sector, on regional cooperation between Member States, and between Member States and third countries, on guarantees of origin, on administrative procedures and on information and training. It also establishes sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids and biomass fuels. Article 2 Definitions For the purposes of this Directive, the relevant definitions in Directive 2009/72/EC of the European Parliament and of the Council (22) apply. The following definitions also apply: (1) \u2018energy from renewable sources\u2019 or \u2018renewable energy\u2019 means energy from renewable non-fossil sources, namely wind, solar (solar thermal and solar photovoltaic) and geothermal energy, ambient energy, tide, wave and other ocean energy, hydropower, biomass, landfill gas, sewage treatment plant gas, and biogas; (2) \u2018ambient energy\u2019 means naturally occurring thermal energy and energy accumulated in the environment with constrained boundaries, which can be stored in the ambient air, excluding in exhaust air, or in surface or sewage water; (3) \u2018geothermal energy\u2019 means energy stored in the form of heat beneath the surface of solid earth; (4) \u2018gross final consumption of energy\u2019 means the energy commodities delivered for energy purposes to industry, transport, households, services including public services, agriculture, forestry and fisheries, the consumption of electricity and heat by the energy branch for electricity, heat and transport fuel production, and losses of electricity and heat in distribution and transmission; (5) \u2018support scheme\u2019 means any instrument, scheme or mechanism applied by a Member State, or a group of Member States, that promotes the use of energy from renewable sources by reducing the cost of that energy, increasing the price at which it can be sold, or increasing, by means of a renewable energy obligation or otherwise, the volume of such energy purchased, including but not restricted to, investment aid, tax exemptions or reductions, tax refunds, renewable energy obligation support schemes including those using green certificates, and direct price support schemes including feed-in tariffs and sliding or fixed premium payments; (6) \u2018renewable energy obligation\u2019 means a support scheme requiring energy producers to include a given share of energy from renewable sources in their production, requiring energy suppliers to include a given share of energy from renewable sources in their supply, or requiring energy consumers to include a given share of energy from renewable sources in their consumption, including schemes under which such requirements may be fulfilled by using green certificates; (7) \u2018financial instrument\u2019 means a financial instrument as defined in point (29) of Article 2 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (23); (8) \u2018SME\u2019 means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC (24); (9) \u2018waste heat and cold\u2019 means unavoidable heat or cold generated as by-product in industrial or power generation installations, or in the tertiary sector, which would be dissipated unused in air or water without access to a district heating or cooling system, where a cogeneration process has been used or will be used or where cogeneration is not feasible; (10) \u2018repowering\u2019 means renewing power plants that produce renewable energy, including the full or partial replacement of installations or operation systems and equipment for the purposes of replacing capacity or increasing the efficiency or capacity of the installation; (11) \u2018distribution system operator\u2019 means an operator as defined in point (6) of Article 2 of Directive 2009/72/EC and in point (6) of Article 2 of Directive 2009/73/EC of the European Parliament and of the Council (25); (12) \u2018guarantee of origin\u2019 means an electronic document which has the sole function of providing evidence to a final customer that a given share or quantity of energy was produced from renewable sources; (13) \u2018residual energy mix\u2019 means the total annual energy mix for a Member State, excluding the share covered by cancelled guarantees of origin; (14) \u2018renewables self-consumer\u2019 means a final customer operating within its premises located within confined boundaries or, where permitted by a Member State, within other premises, who generates renewable electricity for its own consumption, and who may store or sell self-generated renewable electricity, provided that, for a non-household renewables self-consumer, those activities do not constitute its primary commercial or professional activity; (15) \u2018jointly acting renewables self-consumers\u2019 means a group of at least two jointly acting renewables self-consumers in accordance with point (14) who are located in the same building or multi-apartment block; (16) \u2018renewable energy community\u2019 means a legal entity: (a) which, in accordance with the applicable national law, is based on open and voluntary participation, is autonomous, and is effectively controlled by shareholders or members that are located in the proximity of the renewable energy projects that are owned and developed by that legal entity; (b) the shareholders or members of which are natural persons, SMEs or local authorities, including municipalities; (c) the primary purpose of which is to provide environmental, economic or social community benefits for its shareholders or members or for the local areas where it operates, rather than financial profits; (17) \u2018renewables power purchase agreement\u2019 means a contract under which a natural or legal person agrees to purchase renewable electricity directly from an electricity producer; (18) \u2018peer-to-peer trading\u2019 of renewable energy means the sale of renewable energy between market participants by means of a contract with pre-determined conditions governing the automated execution and settlement of the transaction, either directly between market participants or indirectly through a certified third-party market participant, such as an aggregator. The right to conduct peer-to-peer trading shall be without prejudice to the rights and obligations of the parties involved as final customers, producers, suppliers or aggregators; (19) \u2018district heating\u2019 or \u2018district cooling\u2019 means the distribution of thermal energy in the form of steam, hot water or chilled liquids, from central or decentralised sources of production through a network to multiple buildings or sites, for the use of space or process heating or cooling; (20) \u2018efficient district heating and cooling\u2019 means efficient district heating and cooling as defined in point (41) of Article 2 of Directive 2012/27/EU; (21) \u2018high-efficiency cogeneration\u2019 means high-efficiency cogeneration as defined in point (34) of Article 2 of Directive 2012/27/EU; (22) \u2018energy performance certificate\u2019 means energy performance certificate as defined in point (12) of Article 2 of Directive 2010/31/EU; (23) \u2018waste\u2019 means waste as defined in point (1) of Article 3 of Directive 2008/98/EC, excluding substances that have been intentionally modified or contaminated in order to meet this definition; (24) \u2018biomass\u2019 means the biodegradable fraction of products, waste and residues from biological origin from agriculture, including vegetal and animal substances, from forestry and related industries, including fisheries and aquaculture, as well as the biodegradable fraction of waste, including industrial and municipal waste of biological origin; (25) \u2018agricultural biomass\u2019 means biomass produced from agriculture; (26) \u2018forest biomass\u2019 means biomass produced from forestry; (27) \u2018biomass fuels\u2019 means gaseous and solid fuels produced from biomass; (28) \u2018biogas\u2019 means gaseous fuels produced from biomass; (29) \u2018biowaste\u2019 means biowaste as defined in point (4) of Article 3 of Directive 2008/98/EC; (30) \u2018sourcing area\u2019 means the geographically defined area from which the forest biomass feedstock is sourced, from which reliable and independent information is available and where conditions are sufficiently homogeneous to evaluate the risk of the sustainability and legality characteristics of the forest biomass; (31) \u2018forest regeneration\u2019 means the re-establishment of a forest stand by natural or artificial means following the removal of the previous stand by felling or as a result of natural causes, including fire or storm; (32) \u2018bioliquids\u2019 means liquid fuel for energy purposes other than for transport, including electricity and heating and cooling, produced from biomass; (33) \u2018biofuels\u2019 means liquid fuel for transport produced from biomass; (34) \u2018advanced biofuels\u2019 means biofuels that are produced from the feedstock listed in Part A of Annex IX; (35) \u2018recycled carbon fuels\u2019 means liquid and gaseous fuels that are produced from liquid or solid waste streams of non-renewable origin which are not suitable for material recovery in accordance with Article 4 of Directive 2008/98/EC, or from waste processing gas and exhaust gas of non-renewable origin which are produced as an unavoidable and unintentional consequence of the production process in industrial installations; (36) \u2018renewable liquid and gaseous transport fuels of non-biological origin\u2019 means liquid or gaseous fuels which are used in the transport sector other than biofuels or biogas, the energy content of which is derived from renewable sources other than biomass; (37) \u2018low indirect land-use change-risk biofuels, bioliquids and biomass fuels\u2019 means biofuels, bioliquids and biomass fuels, the feedstock of which was produced within schemes which avoid displacement effects of food and feed-crop based biofuels, bioliquids and biomass fuels through improved agricultural practices as well as through the cultivation of crops on areas which were previously not used for cultivation of crops, and which were produced in accordance with the sustainability criteria for biofuels, bioliquids and biomass fuels laid down in Article 29; (38) \u2018fuel supplier\u2019 means an entity supplying fuel to the market that is responsible for passing fuel through an excise duty point or, in the case of electricity or where no excise is due or where duly justified, any other relevant entity designated by a Member State; (39) \u2018starch-rich crops\u2019 means crops comprising mainly cereals, regardless of whether the grains alone or the whole plant, such as in the case of green maize, are used; tubers and root crops, such as potatoes, Jerusalem artichokes, sweet potatoes, cassava and yams; and corm crops, such as taro and cocoyam; (40) \u2018food and feed crops\u2019 means starch-rich crops, sugar crops or oil crops produced on agricultural land as a main crop excluding residues, waste or ligno-cellulosic material and intermediate crops, such as catch crops and cover crops, provided that the use of such intermediate crops does not trigger demand for additional land; (41) \u2018ligno-cellulosic material\u2019 means material composed of lignin, cellulose and hemicellulose, such as biomass sourced from forests, woody energy crops and forest-based industries' residues and wastes; (42) \u2018non-food cellulosic material\u2019 means feedstock mainly composed of cellulose and hemicellulose, and having a lower lignin content than ligno-cellulosic material, including food and feed crop residues, such as straw, stover, husks and shells; grassy energy crops with a low starch content, such as ryegrass, switchgrass, miscanthus, giant cane; cover crops before and after main crops; ley crops; industrial residues, including from food and feed crops after vegetal oils, sugars, starches and protein have been extracted; and material from biowaste, where ley and cover crops are understood to be temporary, short-term sown pastures comprising grass-legume mixture with a low starch content to obtain fodder for livestock and improve soil fertility for obtaining higher yields of arable main crops; (43) \u2018residue\u2019 means a substance that is not the end product(s) that a production process directly seeks to produce; it is not a primary aim of the production process and the process has not been deliberately modified to produce it; (44) \u2018agricultural, aquaculture, fisheries and forestry residues\u2019 means residues that are directly generated by agriculture, aquaculture, fisheries and forestry and that do not include residues from related industries or processing; (45) \u2018actual value\u2019 means the greenhouse gas emissions savings for some or all of the steps of a specific biofuel, bioliquid or biomass fuel production process, calculated in accordance with the methodology laid down in Part C of Annex V or Part B of Annex VI; (46) \u2018typical value\u2019 means an estimate of the greenhouse gas emissions and greenhouse gas emissions savings for a particular biofuel, bioliquid or biomass fuel production pathway, which is representative of the Union consumption; (47) \u2018default value\u2019 means a value derived from a typical value by the application of pre-determined factors and that may, in circumstances specified in this Directive, be used in place of an actual value. Article 3 Binding overall Union target for 2030 1. Member States shall collectively ensure that the share of energy from renewable sources in the Union's gross final consumption of energy in 2030 is at least 32 %. The Commission shall assess that target with a view to submitting a legislative proposal by 2023 to increase it where there are further substantial costs reductions in the production of renewable energy, where needed to meet the Union's international commitments for decarbonisation, or where a significant decrease in energy consumption in the Union justifies such an increase. 2. Member States shall set national contributions to meet, collectively, the binding overall Union target set in paragraph 1 of this Article as part of their integrated national energy and climate plans in accordance with Articles 3 to 5 and 9 to 14 of Regulation (EU) 2018/1999. In preparing their draft integrated national energy and climate plans, Member States may consider the formula referred to in Annex II to that Regulation. If, on the basis of the assessment of the draft integrated national energy and climate plans submitted pursuant to Article 9 of Regulation (EU) 2018/1999, the Commission concludes that the national contributions of the Member States are insufficient for the collective achievement of the binding overall Union target, it shall follow the procedure laid down in Articles 9 and 31 of that Regulation. 3. Member States shall ensure that their national policies, including the obligations deriving from Articles 25 to 28 of this Directive, and their support schemes, are designed with due regard to the waste hierarchy as set out in Article 4 of Directive 2008/98/EC to aim to avoid undue distortive effects on the raw material markets. Member States shall grant no support for renewable energy produced from the incineration of waste if the separate collection obligations laid down in that Directive have not been complied with. 4. From 1 January 2021, the share of energy from renewable sources in each Member State's gross final consumption of energy shall not be lower than the baseline share shown in the third column of the table in Part A of Annex I to this Directive. Member States shall take the necessary measures to ensure compliance with that baseline share. If a Member State does not maintain its baseline share as measured over any one-year period, the first and second subparagraphs of Article 32(4) of Regulation (EU) 2018/1999 shall apply. 5. The Commission shall support the high ambition of Member States through an enabling framework comprising the enhanced use of Union funds, including additional funds to facilitate a just transition of carbon intensive regions towards increased shares of renewable energy, in particular financial instruments, especially for the following purposes: (a) reducing the cost of capital for renewable energy projects; (b) developing projects and programmes for integrating renewable sources into the energy system, for increasing flexibility of the energy system, for maintaining grid stability and for managing grid congestions; (c) developing transmission and distribution grid infrastructure, intelligent networks, storage facilities and interconnections, with the objective of arriving at a 15 % electricity interconnection target by 2030, in order to increase the technically feasible and economically affordable level of renewable energy in the electricity system; (d) enhancing regional cooperation between Member States and between Member States and third countries, through joint projects, joint support schemes and the opening of support schemes for renewable electricity to producers located in other Member States. 6. The Commission shall establish a facilitative platform in order to support Member States that use cooperation mechanisms to contribute to the binding overall Union target set in paragraph 1. Article 4 Support schemes for energy from renewable sources 1. In order to reach or exceed the Union target set in Article 3(1), and each Member State's contribution to that target set at a national level for the deployment of renewable energy, Member States may apply support schemes. 2. Support schemes for electricity from renewable sources shall provide incentives for the integration of electricity from renewable sources in the electricity market in a market-based and market-responsive way, while avoiding unnecessary distortions of electricity markets as well as taking into account possible system integration costs and grid stability. 3. Support schemes for electricity from renewable sources shall be designed so as to maximise the integration of electricity from renewable sources in the electricity market and to ensure that renewable energy producers are responding to market price signals and maximise their market revenues. To that end, with regard to direct price support schemes, support shall be granted in the form of a market premium, which could be, inter alia, sliding or fixed. Member States may exempt small-scale installations and demonstration projects from this paragraph, without prejudice to the applicable Union law on the internal market for electricity. 4. Member States shall ensure that support for electricity from renewable sources is granted in an open, transparent, competitive, non-discriminatory and cost-effective manner. Member States may exempt small-scale installations and demonstration projects from tendering procedures. Member States may also consider establishing mechanisms to ensure the regional diversification in the deployment of renewable electricity, in particular to ensure cost-efficient system integration. 5. Member States may limit tendering procedures to specific technologies where opening support schemes to all producers of electricity from renewable sources would lead to a suboptimal result, in view of: (a) the long-term potential of a particular technology; (b) the need to achieve diversification; (c) grid integration costs; (d) network constraints and grid stability; (e) for biomass, the need to avoid distortions of raw materials markets. 6. Where support for electricity from renewable sources is granted by means of a tendering procedure, Member States shall, in order to ensure a high project realisation rate: (a) establish and publish non-discriminatory and transparent criteria to qualify for the tendering procedure and set clear dates and rules for delivery of the project; (b) publish information about previous tendering procedures, including project realisation rates. 7. In order to increase the generation of energy from renewable sources in the outermost regions and small islands, Member States may adapt financial support schemes for projects located in those regions in order to take into account the production costs associated with their specific conditions of isolation and external dependence. 8. By 31 December 2021 and every three years thereafter, the Commission shall report to the European Parliament and to the Council on the performance of support for electricity from renewable sources granted by means of tendering procedures in the Union, analysing in particular the ability of tendering procedures to: (a) achieve cost-reduction; (b) achieve technological improvement; (c) achieve high realisation rates; (d) provide non-discriminatory participation of small actors and, where applicable, local authorities; (e) limit environmental impact; (f) ensure local acceptability; (g) ensure security of supply and grid integration. 9. This Article shall apply without prejudice to Articles 107 and 108 TFEU. Article 5 Opening of support schemes for electricity from renewable sources 1. Member States shall have the right, in accordance with Articles 7 to 13 of this Directive, to decide to which extent they support electricity from renewable sources which is produced in another Member State. However, Member States may open participation in support schemes for electricity from renewable sources to producers located in other Member States, subject to the conditions laid down in this Article. When opening participation in support schemes for electricity from renewable sources, Member States may provide that support for an indicative share of the newly-supported capacity, or of the budget allocated thereto, in each year is open to producers located in other Member States. Such indicative shares may, in each year, amount to at least 5 % from 2023 to 2026 and at least 10 % from 2027 to 2030, or, where lower, to the level of interconnectivity of the Member State concerned in any given year. In order to acquire further implementation experience, Member States may organise one or more pilot schemes where support is open to producers located in other Member States. 2. Member States may require proof of physical import of electricity from renewable sources. To that end, Member States may limit participation in their support schemes to producers located in Member States with which there is a direct connection via interconnectors. However, Member States shall not change or otherwise affect cross-zonal schedules and capacity allocation due to producers participating in cross-border support schemes. Cross-border electricity transfers shall be determined only by the outcome of capacity allocation pursuant to Union law on the internal market in electricity. 3. If a Member State decides to open participation in support schemes to producers located in other Member States, the relevant Member States shall agree on the principles of such participation. Such agreements shall cover at least the principles of allocation of renewable electricity that is the subject of cross-border support. 4. The Commission shall, upon the request of the relevant Member States, assist them throughout the negotiation process with the setting up of cooperation arrangements by providing information and analysis, including quantitative and qualitative data on the direct and indirect costs and benefits of cooperation, as well as with guidance and technical expertise. The Commission may encourage or facilitate the exchange of best practices and may develop templates for cooperation agreements in order to facilitate the negotiation process. The Commission shall assess, by 2025, the costs and benefits of the deployment of electricity from renewable sources in the Union pursuant to this Article. 5. By 2023, the Commission shall carry out an evaluation of the implementation of this Article. That evaluation shall assess the need to introduce an obligation on Member States partially to open participation in their support schemes for electricity from renewable sources to producers located in other Member States with a view to a 5 % opening by 2025 and a 10 % opening by 2030. Article 6 Stability of financial support 1. Without prejudice to adaptations necessary to comply with Articles 107 and 108 TFEU, Member States shall ensure that the level of, and the conditions attached to, the support granted to renewable energy projects are not revised in a way that negatively affects the rights conferred thereunder and undermines the economic viability of projects that already benefit from support. 2. Member States may adjust the level of support in accordance with objective criteria, provided that such criteria are established in the original design of the support scheme. 3. Member States shall publish a long-term schedule anticipating the expected allocation of support, covering, as a reference, at least the following five years, or, in the case of budgetary planning constraints, the following three years, including the indicative timing, the frequency of tendering procedures where appropriate, the expected capacity and budget or maximum unitary support expected to be allocated, and the expected eligible technologies, if applicable. That schedule shall be updated on an annual basis or, where necessary, to reflect recent market developments or expected allocation of support. 4. Member States shall, at least every five years, assess the effectiveness of their support schemes for electricity from renewable sources and their major distributive effects on different consumer groups, and on investments. That assessment shall take into account the effect of possible changes to the support schemes. The indicative long-term planning governing the decisions of the support and design of new support shall take into account the results of that assessment. Member States shall include the assessment in the relevant updates of their integrated national energy and climate plans and progress reports in accordance with Regulation (EU) 2018/1999. Article 7 Calculation of the share of energy from renewable sources 1. The gross final consumption of energy from renewable sources in each Member State shall be calculated as the sum of: (a) gross final consumption of electricity from renewable sources; (b) gross final consumption of energy from renewable sources in the heating and cooling sector; and (c) final consumption of energy from renewable sources in the transport sector. With regard to point (a), (b), or (c) of the first subparagraph, gas, electricity and hydrogen from renewable sources shall be considered only once for the purposes of calculating the share of gross final consumption of energy from renewable sources. Subject to the second subparagraph of Article 29(1), biofuels, bioliquids and biomass fuels that do not fulfil the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) shall not be taken into account. 2. For the purposes of point (a) of the first subparagraph of paragraph 1, gross final consumption of electricity from renewable sources shall be calculated as the quantity of electricity produced in a Member State from renewable sources, including the production of electricity from renewables self-consumers and renewable energy communities and excluding the production of electricity in pumped storage units from water that has previously been pumped uphill. In multi-fuel plants using renewable and non-renewable sources, only the part of electricity produced from renewable sources shall be taken into account. For the purposes of that calculation, the contribution of each energy source shall be calculated on the basis of its energy content. The electricity generated by hydropower and wind power shall be accounted for in accordance with the normalisation rules set out in Annex II. 3. For the purposes of point (b) of the first subparagraph of paragraph 1, gross final consumption of energy from renewable sources in the heating and cooling sector shall be calculated as the quantity of district heating and cooling produced in a Member State from renewable sources, plus the consumption of other energy from renewable sources in industry, households, services, agriculture, forestry and fisheries, for heating, cooling and processing purposes. In multi-fuel plants using renewable and non-renewable sources, only the part of heating and cooling produced from renewable sources shall be taken into account. For the purposes of that calculation, the contribution of each energy source shall be calculated on the basis of its energy content. Ambient and geothermal energy used for heating and cooling by means of heat pumps and district cooling systems shall be taken into account for the purposes of point (b) of the first subparagraph of paragraph 1, provided that the final energy output significantly exceeds the primary energy input required to drive the heat pumps. The quantity of heat or cold to be considered to be energy from renewable sources for the purposes of this Directive shall be calculated in accordance with the methodology set out in Annex VII and shall take into account energy use in all end-use sectors. Thermal energy generated by passive energy systems, under which lower energy consumption is achieved passively through building design or from heat generated by energy from non-renewable sources, shall not be taken into account for the purposes of point (b) of the first subparagraph of paragraph 1. By 31 December 2021, the Commission shall adopt delegated acts in accordance with Article 35 to supplement this Directive by establishing a methodology for calculating the quantity of renewable energy used for cooling and district cooling and to amend Annex VII. That methodology shall include minimum seasonal performance factors for heat pumps operating in reverse mode. 4. For the purposes of point (c) of the first subparagraph of paragraph 1, the following requirements shall apply: (a) Final consumption of energy from renewable sources in the transport sector shall be calculated as the sum of all biofuels, biomass fuels and renewable liquid and gaseous transport fuels of non-biological origin consumed in the transport sector. However, renewable liquid and gaseous transport fuels of non-biological origin that are produced from renewable electricity shall be considered to be part of the calculation pursuant to point (a) of the first subparagraph of paragraph 1 only when calculating the quantity of electricity produced in a Member State from renewable sources. (b) For the calculation of final consumption of energy in the transport sector, the values regarding the energy content of transport fuels, as set out in Annex III, shall be used. For the determination of the energy content of transport fuels not included in Annex III, Member States shall use the relevant European Standards Organisation (ESO) standards in order to determine the calorific values of fuels. Where no ESO standard has been adopted for that purpose, Member States shall use the relevant International Organization for Standardisation (ISO) standards. 5. The share of energy from renewable sources shall be calculated as the gross final consumption of energy from renewable sources divided by the gross final consumption of energy from all energy sources, expressed as a percentage. For the purposes of the first subparagraph of this paragraph, the sum referred to in the first subparagraph of paragraph 1 of this Article shall be adjusted in accordance with Articles 8, 10, 12 and 13. In calculating a Member State's gross final consumption of energy for the purposes of measuring its compliance with the targets and indicative trajectory laid down in this Directive, the amount of energy consumed in aviation shall, as a proportion of that Member State's gross final consumption of energy, be considered to be no more than 6,18 %. For Cyprus and Malta the amount of energy consumed in aviation shall, as a proportion of those Member States' gross final consumption of energy, be considered to be no more than 4,12 %. 6. The methodology and definitions used in the calculation of the share of energy from renewable sources shall be those provided for in Regulation (EC) No 1099/2008. Member States shall ensure coherence of the statistical information used in calculating those sectoral and overall shares and of the statistical information reported to the Commission pursuant to that Regulation. Article 8 Union renewable development platform and statistical transfers between Member States 1. Member States may agree on the statistical transfer of a specified amount of energy from renewable sources from one Member State to another Member State. The transferred quantity shall be: (a) deducted from the amount of energy from renewable sources that is taken into account in calculating the renewable energy share of the Member State making the transfer for the purposes of this Directive; and (b) added to the amount of energy from renewable sources that is taken into account in calculating the renewable energy share of the Member State accepting the transfer for the purposes of this Directive. 2. In order to facilitate the achievement of the Union target set in Article 3(1) of this Directive and of each Member State's contribution to that target in accordance with Article 3(2) of this Directive, and to facilitate statistical transfers in accordance with paragraph 1 of this Article, the Commission shall establish a Union renewable development platform (\u2018URDP\u2019). Member States may, on a voluntary basis, submit to the URDP annual data on their national contributions to the Union target or any benchmark set for monitoring progress in Regulation (EU) 2018/1999, including the amount by which they expect to fall short of or exceed their contribution, and an indication of the price at which they would accept to transfer any excess production of energy from renewable sources from or to another Member State. The price of those transfers shall be set on a case-by-case basis based on the URDP demand-and-supply matching mechanism. 3. The Commission shall ensure that the URDP is able to match the demand for and supply of the amounts of energy from renewable sources that are taken into account in the calculation of the renewable energy share of a Member State based on prices or other criteria specified by the Member State accepting the transfer. The Commission is empowered to adopt delegated acts in accordance with Article 35 to supplement this Directive by establishing the URDP and setting the conditions for the finalisation of transfers as referred to in paragraph 5 of this Article. 4. The arrangements referred to in paragraphs 1 and 2 may have a duration of one or more calendar years. Such arrangements shall be notified to the Commission or finalised on the URDP not later than 12 months after the end of each year in which they have effect. The information sent to the Commission shall include the quantity and price of the energy involved. For transfers finalised on the URDP, the parties involved and the information on the particular transfer shall be disclosed to the public. 5. Transfers shall become effective after all Member States involved in the transfer have notified the transfer to the Commission or after all clearing conditions are met on the URDP, as applicable. Article 9 Joint projects between Member States 1. Two or more Member States may cooperate on all types of joint projects with regard to the production of electricity, heating or cooling from renewable sources. Such cooperation may involve private operators. 2. Member States shall notify the Commission of the proportion or amount of electricity, heating or cooling from renewable sources produced by any joint project in their territory that became operational after 25 June 2009, or by the increased capacity of an installation that was refurbished after that date, which is to be regarded as counting towards the renewable energy share of another Member State for the purposes of this Directive. 3. The notification referred to in paragraph 2 shall: (a) describe the proposed installation or identify the refurbished installation; (b) specify the proportion or amount of electricity or heating or cooling produced from the installation which is to be regarded as counting towards the renewable energy share of the other Member State; (c) identify the Member State in whose favour the notification is being made; and (d) specify the period, in whole calendar years, during which the electricity or heating or cooling produced by the installation from renewable sources is to be regarded as counting towards the renewable energy share of the other Member State. 4. The duration of a joint project as referred to in this Article may extend beyond 2030. 5. A notification made under this Article shall not be varied or withdrawn without the joint agreement of the Member State making the notification and the Member State identified in accordance with point (c) of paragraph 3. 6. The Commission shall, upon the request of the Member States concerned, facilitate the establishment of joint projects between Member States, in particular via dedicated technical assistance and project development assistance. Article 10 Effects of joint projects between Member States 1. Within three months of the end of each year falling within the period referred to in point (d) of Article 9(3), the Member State that made the notification under Article 9 shall issue a letter of notification stating: (a) the total amount of electricity or heating or cooling produced from renewable sources during that year by the installation which was the subject of the notification under Article 9; and (b) the amount of electricity or heating or cooling produced from renewable sources during that year by that installation which is to count towards the renewable energy share of another Member State in accordance with the terms of the notification. 2. The notifying Member State shall submit the letter of notification to the Member State in whose favour the notification was made and to the Commission. 3. For the purposes of this Directive, the amount of electricity or heating or cooling from renewable sources notified in accordance with point (b) of paragraph 1 shall be: (a) deducted from the amount of electricity or heating or cooling from renewable sources that is taken into account in calculating the renewable energy share of the Member State issuing the letter of notification pursuant to paragraph 1; and (b) added to the amount of electricity or heating or cooling from renewable sources that is taken into account in calculating the renewable energy share of the Member State receiving the letter of notification pursuant to paragraph 2. Article 11 Joint projects between Member States and third countries 1. One or more Member States may cooperate with one or more third countries on all types of joint projects with regard to the production of electricity from renewable sources. Such cooperation may involve private operators and shall take place in full respect of international law. 2. Electricity from renewable sources produced in a third country shall be taken into account for the purposes of calculating the renewable energy shares of the Member States only where the following conditions are met: (a) the electricity is consumed in the Union, which is deemed to be met where: (i) an equivalent amount of electricity to the electricity accounted for has been firmly nominated to the allocated interconnection capacity by all responsible transmission system operators in the country of origin, the country of destination and, if relevant, each third country of transit; (ii) an equivalent amount of electricity to the electricity accounted for has been firmly registered in the schedule of balance by the responsible transmission system operator on the Union side of an interconnector; and (iii) the nominated capacity and the production of electricity from renewable sources by the installation referred to in point (b) refer to the same period of time; (b) the electricity is produced by an installation that became operational after 25 June 2009 or by the increased capacity of an installation that was refurbished after that date, under a joint project as referred to in paragraph 1; (c) the amount of electricity produced and exported has not received support from a support scheme of a third country other than investment aid granted to the installation; and (d) the electricity has been produced in accordance with international law, in a third country that is a signatory to the Council of Europe Convention for the Protection of Human Rights and Fundamental Freedoms, or other international conventions or treaties on human rights. 3. For the purposes of paragraph 4, Member States may apply to the Commission for account to be taken of electricity from renewable sources produced and consumed in a third country, in the context of the construction of an interconnector with a very long lead-time between a Member State and a third country where the following conditions are met: (a) construction of the interconnector started by 31 December 2026; (b) it is not possible for the interconnector to become operational by 31 December 2030; (c) it is possible for the interconnector to become operational by 31 December 2032; (d) after it becomes operational, the interconnector will be used for the export to the Union, in accordance with paragraph 2, of electricity from renewable sources; (e) the application relates to a joint project that fulfils the criteria set out in points (b) and (c) of paragraph 2 and that will use the interconnector after it becomes operational, and to a quantity of electricity that is no greater than the quantity that will be exported to the Union after the interconnector becomes operational. 4. The proportion or amount of electricity produced by any installation in the territory of a third country, which is to be regarded as counting towards the renewable energy share of one or more Member States for the purposes of this Directive, shall be notified to the Commission. When more than one Member State is concerned, the distribution between Member States of that proportion or amount shall be notified to the Commission. The proportion or amount shall not exceed the proportion or amount actually exported to, and consumed in, the Union, shall correspond to the amount referred to in point (a)(i) and (ii) of paragraph 2 and shall meet the conditions set out in point (a) of that paragraph. The notification shall be made by each Member State towards whose overall national target the proportion or amount of electricity is to count. 5. The notification referred to in paragraph 4 shall: (a) describe the proposed installation or identify the refurbished installation; (b) specify the proportion or amount of electricity produced from the installation which is to be regarded as counting towards the renewable energy share of a Member State as well as, subject to confidentiality requirements, the corresponding financial arrangements; (c) specify the period, in whole calendar years, during which the electricity is to be regarded as counting towards the renewable energy share of the Member State; and (d) include a written acknowledgement of points (b) and (c) by the third country in whose territory the installation is to become operational and an indication of the proportion or amount of electricity produced by the installation which will be used domestically by that third country. 6. The duration of a joint project as referred to in this Article may extend beyond 2030. 7. A notification made under this Article shall be varied or withdrawn only where there is a joint agreement between the Member State making the notification and the third country that has acknowledged the joint project in accordance with point (d) of paragraph 5. 8. Member States and the Union shall encourage the relevant bodies of the Energy Community to take, in conformity with the Energy Community Treaty, the measures necessary to allow the Contracting Parties to apply the provisions on cooperation between Member States laid down in this Directive. Article 12 Effects of joint projects between Member States and third countries 1. Within 12 months of the end of each year falling within the period specified under point (c) of Article 11(5), the notifying Member State shall issue a letter of notification stating: (a) the total amount of electricity produced from renewable sources during that year by the installation which was the subject of the notification under Article 11; (b) the amount of electricity produced from renewable sources during that year by that installation which is to count towards its renewable energy share in accordance with the terms of the notification under Article 11; and (c) evidence of compliance with the conditions laid down in Article 11(2). 2. The Member State referred to in paragraph 1 shall submit the letter of notification to the Commission and to the third country that has acknowledged the project in accordance with point (d) of Article 11(5). 3. For the purposes of calculating the renewable energy shares under this Directive, the amount of electricity from renewable sources notified in accordance with point (b) of paragraph 1 shall be added to the amount of energy from renewable sources that is taken into account in calculating the renewable energy shares of the Member State issuing the letter of notification. Article 13 Joint support schemes 1. Without prejudice to the obligations of Member States under Article 5, two or more Member States may decide, on a voluntary basis, to join or partly coordinate their national support schemes. In such cases, a certain amount of energy from renewable sources produced in the territory of one participating Member State may count towards the renewable energy share of another participating Member State, provided that the Member States concerned: (a) make a statistical transfer of specified amounts of energy from renewable sources from one Member State to another Member State in accordance with Article 8; or (b) set up a distribution rule agreed by participating Member States that allocates amounts of energy from renewable sources between the participating Member States. A distribution rule as referred to in point (b) of the first subparagraph shall be notified to the Commission not later than three months after the end of the first year in which it takes effect. 2. Within three months of the end of each year, each Member State that has made a notification under the second subparagraph of paragraph 1 shall issue a letter of notification stating the total amount of electricity or heating or cooling from renewable sources produced during the year which is to be the subject of the distribution rule. 3. For the purposes of calculating the renewable energy shares under this Directive, the amount of electricity or heating or cooling from renewable sources notified in accordance with paragraph 2 shall be reallocated between the Member States concerned in accordance with the notified distribution rule. 4. The Commission shall disseminate guidelines and best practices, and, upon the request of the Member States concerned, facilitate the establishment of joint support schemes between Member States. Article 14 Capacity increases For the purposes of Article 9(2) and point (b) of Article 11(2), units of energy from renewable sources imputable to an increase in the capacity of an installation shall be treated as if they were produced by a separate installation becoming operational at the moment at which the increase of capacity occurred. Article 15 Administrative procedures, regulations and codes 1. Member States shall ensure that any national rules concerning the authorisation, certification and licensing procedures that are applied to plants and associated transmission and distribution networks for the production of electricity, heating or cooling from renewable sources, to the process of transformation of biomass into biofuels, bioliquids, biomass fuels or other energy products, and to renewable liquid and gaseous transport fuels of non-biological origin are proportionate and necessary and contribute to the implementation of the energy efficiency first principle. Member States shall, in particular, take the appropriate steps to ensure that: (a) administrative procedures are streamlined and expedited at the appropriate administrative level and predictable timeframes are established for the procedures referred to in the first subparagraph; (b) rules concerning authorisation, certification and licensing are objective, transparent and proportionate, do not discriminate between applicants and take fully into account the particularities of individual renewable energy technologies; (c) administrative charges paid by consumers, planners, architects, builders and equipment and system installers and suppliers are transparent and cost-related; and (d) simplified and less burdensome authorisation procedures, including a simple-notification procedure, are established for decentralised devices, and for producing and storing energy from renewable sources. 2. Member States shall clearly define any technical specifications which are to be met by renewable energy equipment and systems in order to benefit from support schemes. Where European standards exist, including eco-labels, energy labels and other technical reference systems established by the European standardisation bodies, such technical specifications shall be expressed in terms of those standards. Such technical specifications shall not prescribe where the equipment and systems are to be certified and shall not impede the proper functioning of the internal market. 3. Member States shall ensure that their competent authorities at national, regional and local level include provisions for the integration and deployment of renewable energy, including for renewables self-consumption and renewable energy communities, and the use of unavoidable waste heat and cold when planning, including early spatial planning, designing, building and renovating urban infrastructure, industrial, commercial or residential areas and energy infrastructure, including electricity, district heating and cooling, natural gas and alternative fuel networks. Member States shall, in particular, encourage local and regional administrative bodies to include heating and cooling from renewable sources in the planning of city infrastructure where appropriate, and to consult the network operators to reflect the impact of energy efficiency and demand response programs as well as specific provisions on renewables self-consumption and renewable energy communities, on the infrastructure development plans of the operators. 4. Member States shall introduce appropriate measures in their building regulations and codes in order to increase the share of all kinds of energy from renewable sources in the building sector. In establishing such measures or in their support schemes, Member States may take into account, where applicable, national measures relating to substantial increases in renewables self-consumption, in local energy storage and in energy efficiency, relating to cogeneration and relating to passive, low-energy or zero-energy buildings. Member States shall, in their building regulations and codes or by other means with equivalent effect, require the use of minimum levels of energy from renewable sources in new buildings and in existing buildings that are subject to major renovation in so far as technically, functionally and economically feasible, and reflecting the results of the cost-optimal calculation carried out pursuant to Article 5(2) of Directive 2010/31/EU, and in so far as this does not negatively affect indoor air quality. Member States shall permit those minimum levels to be fulfilled, inter alia, through efficient district heating and cooling using a significant share of renewable energy and waste heat and cold. The requirements laid down in the first subparagraph shall apply to the armed forces only to the extent that its application does not cause any conflict with the nature and primary aim of the activities of the armed forces and with the exception of material used exclusively for military purposes. 5. Member States shall ensure that new public buildings, and existing public buildings that are subject to major renovation, at national, regional and local level, fulfil an exemplary role in the context of this Directive from 1 January 2012. Member States may, inter alia, allow that obligation to be fulfilled by complying with nearly zero-energy building provisions as required in Directive 2010/31/EU, or by providing for the roofs of public or mixed private-public buildings to be used by third parties for installations that produce energy from renewable sources. 6. With respect to their building regulations and codes, Member States shall promote the use of renewable heating and cooling systems and equipment that achieve a significant reduction of energy consumption. To that end, Member States shall use energy or eco-labels or other appropriate certificates or standards developed at national or Union level, where these exist, and ensure the provision of adequate information and advice on renewable, highly energy efficient alternatives as well as eventual financial instruments and incentives available in the case of replacement, with a view to promoting an increased replacement rate of old heating systems and an increased switch to solutions based on renewable energy in accordance with Directive 2010/31/EU. 7. Member States shall carry out an assessment of their potential of energy from renewable sources and of the use of waste heat and cold in the heating and cooling sector. That assessment shall, where appropriate, include spatial analysis of areas suitable for low-ecological-risk deployment and the potential for small-scale household projects and shall be included in the second comprehensive assessment required pursuant to Article 14(1) of Directive 2012/27/EU for the first time by 31 December 2020 and in the subsequent updates of the comprehensive assessments. 8. Member States shall assess the regulatory and administrative barriers to long-term renewables power purchase agreements, and shall remove unjustified barriers to, and facilitate the uptake of, such agreements. Member States shall ensure that those agreements are not subject to disproportionate or discriminatory procedures or charges. Member States shall describe policies and measures facilitating the uptake of renewables power purchase agreements in their integrated national energy and climate plans and progress reports pursuant to Regulation (EU) 2018/1999. Article 16 Organisation and duration of the permit-granting process 1. Member States shall set up or designate one or more contact points. Those contact points shall, upon request by the applicant, guide through and facilitate the entire administrative permit application and granting process. The applicant shall not be required to contact more than one contact point for the entire process. The permit-granting process shall cover the relevant administrative permits to build, repower and operate plants for the production of energy from renewable sources and assets necessary for their connection to the grid. The permit-granting process shall comprise all procedures from the acknowledgment of the receipt of the application to the transmission of the outcome of the procedure referred to in paragraph 2. 2. The contact point shall guide the applicant through the administrative permit application process in a transparent manner up to the delivery of one or several decisions by the responsible authorities at the end of the process, provide the applicant with all necessary information and involve, where appropriate, other administrative authorities. Applicants shall be allowed to submit relevant documents also in digital form. 3. The contact point shall make available a manual of procedures for developers of renewable energy production projects and shall provide that information also online, addressing distinctly also small-scale projects and renewables self-consumers projects. The online information shall indicate the contact point relevant to the applicant's application. If a Member State has more than one contact point, the online information shall indicate the contact point relevant to the applicant's application. 4. Without prejudice to paragraph 7, the permit-granting process referred to in paragraph 1 shall not exceed two years for power plants, including all relevant procedures of competent authorities. Where duly justified on the grounds of extraordinary circumstances, that two-year period may be extended by up to one year. 5. Without prejudice to paragraph 7, the permit-granting process shall not exceed one year for installations with an electrical capacity of less than 150 kW. Where duly justified on the grounds of extraordinary circumstances, that one-year period may be extended by up to one year. Member States shall ensure that applicants have easy access to simple procedures for the settlement of disputes concerning the permit-granting process and the issuance of permits to build and operate renewable energy plants, including, where applicable, alternative dispute resolution mechanisms. 6. Member States shall facilitate the repowering of existing renewable energy plants by ensuring a simplified and swift permit-granting process. The length of that process shall not exceed one year. Where duly justified on the grounds of extraordinary circumstances, such as on grounds of overriding safety reasons where the repowering project impacts substantially on the grid or the original capacity, size or performance of the installation, that one-year period may be extended by up to one year. 7. The deadlines established in this Article shall apply without prejudice to obligations under applicable Union environmental law, to judicial appeals, remedies and other proceedings before a court or tribunal, and to alternative dispute resolution mechanisms, including complaints procedures, non-judicial appeals and remedies, and may be extended for the duration of such procedures. 8. Member States may establish a simple-notification procedure for grid connections for repowering projects as referred to in Article 17(1). Where Member States do so, repowering shall be permitted following notification to the relevant authority where no significant negative environmental or social impact is expected. That authority shall decide within six months of receipt of a notification whether this is sufficient. Where the relevant authority decides that a notification is sufficient, it shall automatically grant the permit. Where that authority decides that the notification is not sufficient, it shall be necessary to apply for a new permit and the time-limits referred to in paragraph 6 shall apply. Article 17 Simple-notification procedure for grid connections 1. Member States shall establish a simple-notification procedure for grid connections whereby installations or aggregated production units of renewables self-consumers and demonstration projects, with an electrical capacity of 10,8 kW or less, or equivalent for connections other than three-phase connections, are to be connected to the grid following a notification to the distribution system operator. The distribution system operator may, within a limited period following the notification, reject the requested grid connection or propose an alternative grid connection point on justified grounds of safety concerns or technical incompatibility of the system components. In the case of a positive decision by the distribution system operator, or in the absence of a decision by the distribution system operator within one month following the notification, the installation or aggregated production unit may be connected. 2. Member States may allow a simple-notification procedure for installations or aggregated production units with an electrical capacity of above 10,8 kW and up to 50 kW, provided that grid stability, grid reliability and grid safety are maintained. Article 18 Information and training 1. Member States shall ensure that information on support measures is made available to all relevant actors, such as consumers including low-income, vulnerable consumers, renewables self-consumers, renewable energy communities, builders, installers, architects, suppliers of heating, cooling and electricity equipment and systems, and suppliers of vehicles compatible with the use of renewable energy and of intelligent transport systems. 2. Member States shall ensure that information on the net benefits, cost and energy efficiency of equipment and systems for the use of heating, cooling and electricity from renewable sources is made available either by the supplier of the equipment or system or by the competent authorities. 3. Member States shall ensure that certification schemes or equivalent qualification schemes are available for installers of small-scale biomass boilers and stoves, solar photovoltaic and solar thermal systems, shallow geothermal systems and heat pumps. Those schemes may take into account existing schemes and structures as appropriate, and shall be based on the criteria laid down in Annex IV. Each Member State shall recognise the certification awarded by other Member States in accordance with those criteria. 4. Member States shall make information on certification schemes or equivalent qualification schemes as referred to in paragraph 3 available to the public. Member States may also make the list of installers who are qualified or certified in accordance with paragraph 3 available to the public. 5. Member States shall ensure that guidance is made available to all relevant actors, in particular to planners and architects so that they are able properly to consider the optimal combination of energy from renewable sources, of high-efficiency technologies, and of district heating and cooling when planning, designing, building and renovating industrial, commercial or residential areas. 6. Member States, where appropriate with the participation of local and regional authorities, shall develop suitable information, awareness-raising, guidance or training programmes in order to inform citizens of how to exercise their rights as active customers, and of the benefits and practicalities, including technical and financial aspects, of developing and using energy from renewable sources, including by renewables self-consumption or in the framework of renewable energy communities. Article 19 Guarantees of origin for energy from renewable sources 1. For the purposes of demonstrating to final customers the share or quantity of energy from renewable sources in an energy supplier's energy mix and in the energy supplied to consumers under contracts marketed with reference to the consumption of energy from renewable sources, Member States shall ensure that the origin of energy from renewable sources can be guaranteed as such within the meaning of this Directive, in accordance with objective, transparent and non-discriminatory criteria. 2. To that end, Member States shall ensure that a guarantee of origin is issued in response to a request from a producer of energy from renewable sources, unless Member States decide, for the purposes of accounting for the market value of the guarantee of origin, not to issue such a guarantee of origin to a producer that receives financial support from a support scheme. Member States may arrange for guarantees of origin to be issued for energy from non-renewable sources. Issuance of guarantees of origin may be made subject to a minimum capacity limit. A guarantee of origin shall be of the standard size of 1 MWh. No more than one guarantee of origin shall be issued in respect of each unit of energy produced. Member States shall ensure that the same unit of energy from renewable sources is taken into account only once. Member States shall ensure that when a producer receives financial support from a support scheme, the market value of the guarantee of origin for the same production is taken into account appropriately in the relevant support scheme. It shall be presumed that the market value of the guarantee of origin has been taken into account appropriately in any of the following cases: (a) where the financial support is granted by way of a tendering procedure or a tradable green certificate system; (b) where the market value of the guarantees of origin is administratively taken into account in the level of financial support; or (c) where the guarantees of origin are not issued directly to the producer but to a supplier or consumer who buys the energy from renewable sources either in a competitive setting or in a long-term renewables power purchase agreement. In order to take into account the market value of the guarantee of origin, Member States may, inter alia, decide to issue a guarantee of origin to the producer and immediately cancel it. The guarantee of origin shall have no function in terms of a Member State's compliance with Article 3. Transfers of guarantees of origin, separately or together with the physical transfer of energy, shall have no effect on the decision of Member States to use statistical transfers, joint projects or joint support schemes for compliance with Article 3 or on the calculation of the gross final consumption of energy from renewable sources in accordance with Article 7. 3. For the purposes of paragraph 1, guarantees of origin shall be valid for 12 months after the production of the relevant energy unit. Member States shall ensure that all guarantees of origin that have not been cancelled expire at the latest 18 months after the production of the energy unit. Member States shall include expired guarantees of origin in the calculation of their residual energy mix. 4. For the purposes of disclosure referred to in paragraphs 8 and 13, Member States shall ensure that energy companies cancel guarantees of origin at the latest six months after the end of the validity of the guarantee of origin. 5. Member States or designated competent bodies shall supervise the issuance, transfer and cancellation of guarantees of origin. The designated competent bodies shall not have overlapping geographical responsibilities, and shall be independent of production, trade and supply activities. 6. Member States or the designated competent bodies shall put in place appropriate mechanisms to ensure that guarantees of origin are issued, transferred and cancelled electronically and are accurate, reliable and fraud-resistant. Member States and designated competent bodies shall ensure that the requirements they impose comply with the standard CEN - EN 16325. 7. A guarantee of origin shall specify at least: (a) the energy source from which the energy was produced and the start and end dates of production; (b) whether it relates to: (i) electricity; (ii) gas, including hydrogen; or (iii) heating or cooling; (c) the identity, location, type and capacity of the installation where the energy was produced; (d) whether the installation has benefited from investment support and whether the unit of energy has benefited in any other way from a national support scheme, and the type of support scheme; (e) the date on which the installation became operational; and (f) the date and country of issue and a unique identification number. Simplified information may be specified on guarantees of origin from installations of less than 50 kW. 8. Where an electricity supplier is required to demonstrate the share or quantity of energy from renewable sources in its energy mix for the purposes of point (a) of Article 3(9) of Directive 2009/72/EC, it shall do so by using guarantees of origin except: (a) as regards the share of its energy mix corresponding to non-tracked commercial offers, if any, for which the supplier may use the residual mix; or (b) where a Member State decides not to issue guarantees of origin to a producer that receives financial support from a support scheme. Where Member States have arranged to have guarantees of origin for other types of energy, suppliers shall use for disclosure the same type of guarantees of origin as the energy supplied. Likewise, guarantees of origin created pursuant to Article 14(10) of Directive 2012/27/EU may be used to substantiate any requirement to demonstrate the quantity of electricity produced from high-efficiency cogeneration. For the purposes of paragraph 2 of this Article, where electricity is generated from high-efficiency cogeneration using renewable sources, only one guarantee of origin specifying both characteristics may be issued. 9. Member States shall recognise guarantees of origin issued by other Member States in accordance with this Directive exclusively as evidence of the elements referred to in paragraph 1 and points (a) to (f) of the first subparagraph of paragraph 7. A Member State may refuse to recognise a guarantee of origin only where it has well-founded doubts about its accuracy, reliability or veracity. The Member State shall notify the Commission of such a refusal and its justification. 10. If the Commission finds that a refusal to recognise a guarantee of origin is unfounded, the Commission may adopt a decision requiring the Member State in question to recognise it. 11. Member States shall not recognise guarantees of origins issued by a third country except where the Union has concluded an agreement with that third country on mutual recognition of guarantees of origin issued in the Union and compatible guarantees of origin systems established in that third country, and only where there is direct import or export of energy. 12. A Member State may, in accordance with Union law, introduce objective, transparent and non-discriminatory criteria for the use of guarantees of origin in accordance with the obligations laid down in Article 3(9) of Directive 2009/72/EC. 13. The Commission shall adopt a report assessing options to establish a Union-wide green label with a view to promoting the use of renewable energy coming from new installations. Suppliers shall use the information contained in guarantees of origin to demonstrate compliance with the requirements of such a label. Article 20 Access to and operation of the grids 1. Where relevant, Member States shall assess the need to extend existing gas network infrastructure to facilitate the integration of gas from renewable sources. 2. Where relevant, Member States shall require transmission system operators and distribution system operators in their territory to publish technical rules in accordance with Article 8 of Directive 2009/73/EC, in particular regarding network connection rules that include gas quality, gas odoration and gas pressure requirements. Member States shall also require transmission and distribution system operators to publish the connection tariffs to connect gas from renewable sources based on objective, transparent and non-discriminatory criteria. 3. Subject to their assessment included in the integrated national energy and climate plans in accordance with Annex I to Regulation (EU) 2018/1999 on the necessity to build new infrastructure for district heating and cooling from renewable sources in order to achieve the Union target set in Article 3(1) of this Directive, Member States shall, where relevant, take the necessary steps with a view to developing a district heating and cooling infrastructure to accommodate the development of heating and cooling from large biomass, solar energy, ambient energy and geothermal energy facilities and from waste heat and cold. Article 21 Renewables self-consumers 1. Member States shall ensure that consumers are entitled to become renewables self-consumers, subject to this Article. 2. Member States shall ensure that renewables self-consumers, individually or through aggregators, are entitled: (a) to generate renewable energy, including for their own consumption, store and sell their excess production of renewable electricity, including through renewables power purchase agreements, electricity suppliers and peer-to-peer trading arrangements, without being subject: (i) in relation to the electricity that they consume from or feed into the grid, to discriminatory or disproportionate procedures and charges, and to network charges that are not cost-reflective; (ii) in relation to their self-generated electricity from renewable sources remaining within their premises, to discriminatory or disproportionate procedures, and to any charges or fees; (b) to install and operate electricity storage systems combined with installations generating renewable electricity for self-consumption without liability for any double charge, including network charges, for stored electricity remaining within their premises; (c) to maintain their rights and obligations as final consumers; (d) to receive remuneration, including, where applicable, through support schemes, for the self-generated renewable electricity that they feed into the grid, which reflects the market value of that electricity and which may take into account its long-term value to the grid, the environment and society. 3. Member States may apply non-discriminatory and proportionate charges and fees to renewables self-consumers, in relation to their self-generated renewable electricity remaining within their premises in one or more of the following cases: (a) if the self-generated renewable electricity is effectively supported via support schemes, only to the extent that the economic viability of the project and the incentive effect of such support are not undermined; (b) from 1 December 2026, if the overall share of self-consumption installations exceeds 8 % of the total installed electricity capacity of a Member State, and if it is demonstrated, by means of a cost-benefit analysis performed by the national regulatory authority of that Member State, which is conducted by way of an open, transparent and participatory process, that the provision laid down in point (a)(ii) of paragraph 2 either results in a significant disproportionate burden on the long-term financial sustainability of the electric system, or creates an incentive exceeding what is objectively needed to achieve cost-effective deployment of renewable energy, and that such burden or incentive cannot be minimised by taking other reasonable actions; or (c) if the self-generated renewable electricity is produced in installations with a total installed electrical capacity of more than 30 kW. 4. Member States shall ensure that renewables self-consumers located in the same building, including multi-apartment blocks, are entitled to engage jointly in activities referred to in paragraph 2 and that they are permitted to arrange sharing of renewable energy that is produced on their site or sites between themselves, without prejudice to the network charges and other relevant charges, fees, levies and taxes applicable to each renewables self-consumer. Member States may differentiate between individual renewables self-consumers and jointly acting renewables self-consumers. Any such differentiation shall be proportionate and duly justified. 5. The renewables self-consumer's installation may be owned by a third party or managed by a third party for installation, operation, including metering and maintenance, provided that the third party remains subject to the renewables self-consumer's instructions. The third party itself shall not be considered to be a renewables self-consumer. 6. Member States shall put in place an enabling framework to promote and facilitate the development of renewables self-consumption based on an assessment of the existing unjustified barriers to, and of the potential of, renewables self-consumption in their territories and energy networks. That enabling framework shall, inter alia: (a) address accessibility of renewables self-consumption to all final customers, including those in low-income or vulnerable households; (b) address unjustified barriers to the financing of projects in the market and measures to facilitate access to finance; (c) address other unjustified regulatory barriers to renewables self-consumption, including for tenants; (d) address incentives to building owners to create opportunities for renewables self-consumption, including for tenants; (e) grant renewables self-consumers, for self-generated renewable electricity that they feed into the grid, non-discriminatory access to relevant existing support schemes as well as to all electricity market segments; (f) ensure that renewables self-consumers contribute in an adequate and balanced way to the overall cost sharing of the system when electricity is fed into the grid. Member States shall include a summary of the policies and measures under the enabling framework and an assessment of their implementation respectively in their integrated national energy and climate plans and progress reports pursuant to Regulation (EU) 2018/1999. 7. This Article shall apply without prejudice to Articles 107 and 108 TFEU. Article 22 Renewable energy communities 1. Member States shall ensure that final customers, in particular household customers, are entitled to participate in a renewable energy community while maintaining their rights or obligations as final customers, and without being subject to unjustified or discriminatory conditions or procedures that would prevent their participation in a renewable energy community, provided that for private undertakings, their participation does not constitute their primary commercial or professional activity. 2. Member States shall ensure that renewable energy communities are entitled to: (a) produce, consume, store and sell renewable energy, including through renewables power purchase agreements; (b) share, within the renewable energy community, renewable energy that is produced by the production units owned by that renewable energy community, subject to the other requirements laid down in this Article and to maintaining the rights and obligations of the renewable energy community members as customers; (c) access all suitable energy markets both directly or through aggregation in a non-discriminatory manner. 3. Member States shall carry out an assessment of the existing barriers and potential of development of renewable energy communities in their territories. 4. Member States shall provide an enabling framework to promote and facilitate the development of renewable energy communities. That framework shall ensure, inter alia, that: (a) unjustified regulatory and administrative barriers to renewable energy communities are removed; (b) renewable energy communities that supply energy or provide aggregation or other commercial energy services are subject to the provisions relevant for such activities; (c) the relevant distribution system operator cooperates with renewable energy communities to facilitate energy transfers within renewable energy communities; (d) renewable energy communities are subject to fair, proportionate and transparent procedures, including registration and licensing procedures, and cost-reflective network charges, as well as relevant charges, levies and taxes, ensuring that they contribute, in an adequate, fair and balanced way, to the overall cost sharing of the system in line with a transparent cost-benefit analysis of distributed energy sources developed by the national competent authorities; (e) renewable energy communities are not subject to discriminatory treatment with regard to their activities, rights and obligations as final customers, producers, suppliers, distribution system operators, or as other market participants; (f) the participation in the renewable energy communities is accessible to all consumers, including those in low-income or vulnerable households; (g) tools to facilitate access to finance and information are available; (h) regulatory and capacity-building support is provided to public authorities in enabling and setting up renewable energy communities, and in helping authorities to participate directly; (i) rules to secure the equal and non-discriminatory treatment of consumers that participate in the renewable energy community are in place. 5. The main elements of the enabling framework referred to in paragraph 4, and of its implementation, shall be part of the updates of the Member States' integrated national energy and climate plans and progress reports pursuant to Regulation (EU) 2018/1999. 6. Member States may provide for renewable energy communities to be open to cross-border participation. 7. Without prejudice to Articles 107 and 108 TFEU, Member States shall take into account specificities of renewable energy communities when designing support schemes in order to allow them to compete for support on an equal footing with other market participants. Article 23 Mainstreaming renewable energy in heating and cooling 1. In order to promote the use of renewable energy in the heating and cooling sector, each Member State shall endeavour to increase the share of renewable energy in that sector by an indicative 1,3 percentage points as an annual average calculated for the periods 2021 to 2025 and 2026 to 2030, starting from the share of renewable energy in the heating and cooling sector in 2020, expressed in terms of national share of final energy consumption and calculated in accordance with the methodology set out in Article 7, without prejudice to paragraph 2 of this Article. That increase shall be limited to an indicative 1,1 percentage points for Member States where waste heat and cold is not used. Member States shall, where appropriate, prioritise the best available technologies. 2. For the purposes of paragraph 1, when calculating its share of renewable energy in the heating and cooling sector and its average annual increase in accordance with that paragraph, each Member State: (a) may count waste heat and cold, subject to a limit of 40 % of the average annual increase; (b) where its share of renewable energy in the heating and cooling sector is above 60 %, may count any such share as fulfilling the average annual increase; and (c) where its share of renewable energy in the heating and cooling sector is above 50 % and up to 60 %, may count any such share as fulfilling half of the average annual increase. When deciding which measures to adopt for the purposes of deploying energy from renewable sources in the heating and cooling sector, Member States may take into account cost-effectiveness reflecting structural barriers arising from the high share of natural gas or cooling, or from a dispersed settlement structure with low population density. Where those measures would result in a lower average annual increase than that referred to in paragraph 1 of this Article, Member States shall make it public, for instance by the means of their integrated national energy and climate progress reports pursuant to Article 20 of Regulation (EU) 2018/1999, and provide the Commission with reasons, including of choice of measures as referred to the second subparagraph of this paragraph. 3. On the basis of objective and non-discriminatory criteria, Member States may establish and make public a list of measures and may designate and make public the implementing entities, such as fuel suppliers, public or professional bodies, which are to contribute to the average annual increase referred to in paragraph 1. 4. Member States may implement the average annual increase referred to in paragraph 1 by means, inter alia, of one or more of the following options: (a) physical incorporation of renewable energy or waste heat and cold in the energy and energy fuel supplied for heating and cooling; (b) direct mitigation measures such as the installation of highly efficient renewable heating and cooling systems in buildings, or the use of renewable energy or waste heat and cold in industrial heating and cooling processes; (c) indirect mitigation measures covered by tradable certificates proving compliance with the obligation laid down in paragraph 1 through support to indirect mitigation measures, carried out by another economic operator such as an independent renewable technology installer or energy service company providing renewable installation services; (d) other policy measures, with an equivalent effect, to reach the average annual increase referred to in paragraph 1, including fiscal measures or other financial incentives. When adopting and implementing the measures referred to in the first subparagraph, Member States shall aim to ensure the accessibility of measures to all consumers, in particular those in low-income or vulnerable households, who would not otherwise possess sufficient up-front capital to benefit. 5. Member States may use the structures established under the national energy savings obligations set out in Article 7 of Directive 2012/27/EU to implement and monitor the measures referred to in paragraph 3 of this Article. 6. Where entities are designated under paragraph 3, Member States shall ensure that the contribution by those designated entities is measurable and verifiable and that the designated entities report annually on: (a) the total amount of energy supplied for heating and cooling; (b) the total amount of renewable energy supplied for heating and cooling; (c) the amount of waste heat and cold supplied for heating and cooling; (d) the share of renewable energy and waste heat and cold in the total amount of energy supplied for heating and cooling; and (e) the type of renewable energy source. Article 24 District heating and cooling 1. Member States shall ensure that information on the energy performance and the share of renewable energy in their district heating and cooling systems is provided to final consumers in an easily accessible manner, such as on the suppliers' websites, on annual bills or upon request. 2. Member States shall lay down the necessary measures and conditions to allow customers of district heating or cooling systems which are not efficient district heating and cooling systems, or which are not such a system by 31 December 2025 on the basis of a plan approved by the competent authority, to disconnect by terminating or modifying their contract in order to produce heating or cooling from renewable sources themselves. Where the termination of a contract is linked to physical disconnection, such a termination may be made conditional on compensation for the costs directly incurred as a result of the physical disconnection and for the undepreciated portion of assets needed to provide heat and cold to that customer. 3. Member States may restrict the right to disconnect by terminating or modifying a contract in accordance with paragraph 2 to customers who can demonstrate that the planned alternative supply solution for heating or cooling results in a significantly better energy performance. The energy-performance assessment of the alternative supply solution may be based on the energy performance certificate. 4. Member States shall lay down the necessary measures to ensure that district heating and cooling systems contribute to the increase referred to in Article 23(1) of this Directive by implementing at least one of the two following options: (a) Endeavour to increase the share of energy from renewable sources and from waste heat and cold in district heating and cooling by at least one percentage point as an annual average calculated for the period 2021 to 2025 and for the period 2026 to 2030, starting from the share of energy from renewable sources and from waste heat and cold in district heating and cooling in 2020, expressed in terms of share of final energy consumption in district heating and cooling, by implementing measures that can be expected to trigger that average annual increase in years with normal climatic conditions. Member States with a share of energy from renewable sources and from waste heat and cold in district heating and cooling above 60 % may count any such share as fulfilling the average annual increase referred to in the first subparagraph of this point. Member States shall lay down the necessary measures to implement the average annual increase referred to in the first subparagraph of this point in their integrated national energy and climate plans pursuant to Annex I to Regulation (EU) 2018/1999. (b) Ensure that operators of district heating or cooling systems are obliged to connect suppliers of energy from renewable sources and from waste heat and cold or are obliged to offer to connect and purchase heat or cold from renewable sources and from waste heat and cold from third-party suppliers based on non-discriminatory criteria set by the competent authority of the Member State concerned, where they need to do one or more of the following: (i) meet demand from new customers; (ii) replace existing heat or cold generation capacity; (iii) expand existing heat or cold generation capacity. 5. Where a Member State exercises the option referred to in point (b) of paragraph 4, an operator of a district heating or cooling system may refuse to connect and to purchase heat or cold from a third-party supplier where: (a) the system lacks the necessary capacity due to other supplies of waste heat and cold, of heat or cold from renewable sources or of heat or cold produced by high-efficiency cogeneration; (b) the heat or cold from the third-party supplier does not meet the technical parameters necessary to connect and ensure the reliable and safe operation of the district heating and cooling system; or (c) the operator can demonstrate that providing access would lead to an excessive heat or cold cost increase for final customers compared to the cost of using the main local heat or cold supply with which the renewable source or waste heat and cold would compete. Member States shall ensure that, when an operator of a district heating or cooling system refuses to connect a supplier of heating or cooling pursuant to the first subparagraph, information on the reasons for the refusal, as well as the conditions to be met and measures to be taken in the system in order to enable the connection, is provided by that operator to the competent authority in accordance with paragraph 9. 6. Where a Member State exercises the option referred to in point (b) of paragraph 4, it may exempt operators of the following district heating and cooling systems from the application of that point: (a) efficient district heating and cooling; (b) efficient district heating and cooling that exploits high-efficiency cogeneration; (c) district heating and cooling that, on the basis of a plan approved by the competent authority, is efficient district heating and cooling by 31 December 2025; (d) district heating and cooling with a total rated thermal input below 20 MW. 7. The right to disconnect by terminating or modifying a contract in accordance with paragraph 2 may be exercised by individual customers, by joint undertakings formed by customers or by parties acting on behalf of customers. For multi-apartment blocks, such disconnection may be exercised only at a whole building level in accordance with the applicable housing law. 8. Member States shall require electricity distribution system operators to assess at least every four years, in cooperation with the operators of district heating or cooling systems in their respective area, the potential for district heating or cooling systems to provide balancing and other system services, including demand response and storing of excess electricity from renewable sources, and whether the use of the identified potential would be more resource- and cost-efficient than alternative solutions. 9. Member States shall ensure that the rights of consumers and the rules for operating district heating and cooling systems in accordance with this Article are clearly defined and enforced by the competent authority. 10. A Member State shall not be required to apply paragraphs 2 to 9 of this Article where: (a) its share of district heating and cooling is less than or equal to 2 % of the overall consumption of energy in heating and cooling on 24 December 2018; (b) its share of district heating and cooling is increased above 2 % by developing new efficient district heating and cooling based on its integrated national energy and climate plan pursuant to Annex I to Regulation (EU) 2018/1999 or the assessment referred to in Article 15(7) of this Directive; or (c) its share of systems referred to in paragraph 6 of this Article constitutes over 90 % of total sales of its district heating and cooling. Article 25 Mainstreaming renewable energy in the transport sector 1. In order to mainstream the use of renewable energy in the transport sector, each Member State shall set an obligation on fuel suppliers to ensure that the share of renewable energy within the final consumption of energy in the transport sector is at least 14 % by 2030 (minimum share) in accordance with an indicative trajectory set by the Member State and calculated in accordance with the methodology set out in this Article and in Articles 26 and 27. The Commission shall assess that obligation, with a view to submitting, by 2023, a legislative proposal to increase it in the event of further substantial costs reductions in the production of renewable energy, where necessary to meet the Union's international commitments for decarbonisation, or where justified on the grounds of a significant decrease in energy consumption in the Union. Member States may exempt, or distinguish between, different fuel suppliers and different energy carriers when setting the obligation on the fuel suppliers, ensuring that the varying degrees of maturity and the cost of different technologies are taken into account. For the calculation of the minimum share referred to in the first subparagraph, Member States: (a) shall take into account renewable liquid and gaseous transport fuels of non-biological origin also when they are used as intermediate products for the production of conventional fuels; and (b) may take into account recycled carbon fuels. Within the minimum share referred to in the first subparagraph, the contribution of advanced biofuels and biogas produced from the feedstock listed in Part A of Annex IX as a share of final consumption of energy in the transport sector shall be at least 0,2 % in 2022, at least 1 % in 2025 and at least 3,5 % in 2030. Member States may exempt fuel suppliers supplying fuel in the form of electricity or renewable liquid and gaseous transport fuels of non-biological origin from the requirement to comply with the minimum share of advanced biofuels and biogas produced from the feedstock listed in Part A of Annex IX with respect to those fuels. When setting the obligation referred to in the first and fourth subparagraphs to ensure the achievement of the share set out therein, Member States may do so, inter alia, by means of measures targeting volumes, energy content or greenhouse gas emissions, provided that it is demonstrated that the minimum shares referred to in the first and fourth subparagraphs are achieved. 2. The greenhouse gas emissions savings from the use of renewable liquid and gaseous transport fuels of non-biological origin shall be at least 70 % from 1 January 2021. By 1 January 2021, the Commission shall adopt a delegated act in accordance with Article 35 to supplement this Directive by establishing appropriate minimum thresholds for greenhouse gas emissions savings of recycled carbon fuels through a life-cycle assessment that takes into account the specificities of each fuel. Article 26 Specific rules for biofuels, bioliquids and biomass fuels produced from food and feed crops 1. For the calculation of a Member State's gross final consumption of energy from renewable sources referred to in Article 7 and the minimum share referred to in the first subparagraph of Article 25(1), the share of biofuels and bioliquids, as well as of biomass fuels consumed in transport, where produced from food and feed crops, shall be no more than one percentage point higher than the share of such fuels in the final consumption of energy in the road and rail transport sectors in 2020 in that Member State, with a maximum of 7 % of final consumption of energy in the road and rail transport sectors in that Member State. Where that share is below 1 % in a Member State, it may be increased to a maximum of 2 % of the final consumption of energy in the road and rail transport sectors. Member States may set a lower limit and may distinguish, for the purposes of Article 29(1), between different biofuels, bioliquids and biomass fuels produced from food and feed crops, taking into account best available evidence on indirect land-use change impact. Member States may, for example, set a lower limit for the share of biofuels, bioliquids and biomass fuels produced from oil crops. Where the share of biofuels and bioliquids, as well as of biomass fuels consumed in transport, produced from food and feed crops in a Member State is limited to a share lower than 7 % or a Member State decides to limit the share further, that Member State may reduce the minimum share referred to in the first subparagraph of Article 25(1) accordingly, by a maximum of 7 percentage points. 2. For the calculation of a Member State's gross final consumption of energy from renewable sources referred to in Article 7 and the minimum share referred to in the first subparagraph of Article 25(1), the share of high indirect land-use change-risk biofuels, bioliquids or biomass fuels produced from food and feed crops for which a significant expansion of the production area into land with high-carbon stock is observed shall not exceed the level of consumption of such fuels in that Member State in 2019, unless they are certified to be low indirect land-use change-risk biofuels, bioliquids or biomass fuels pursuant to this paragraph. From 31 December 2023 until 31 December 2030 at the latest, that limit shall gradually decrease to 0 %. By 1 February 2019, the Commission shall submit to the European Parliament and to the Council a report on the status of worldwide production expansion of the relevant food and feed crops. By 1 February 2019, the Commission shall adopt a delegated act in accordance with Article 35 to supplement this Directive by setting out the criteria for certification of low indirect land-use change-risk biofuels, bioliquids and biomass fuels and for determining the high indirect land-use change-risk feedstock for which a significant expansion of the production area into land with high-carbon stock is observed. The report and the accompanying delegated act shall be based on the best available scientific data. By 1 September 2023, the Commission shall review the criteria laid down in the delegated act referred to in the fourth subparagraph based on the best available scientific data and shall adopt delegated acts in accordance with Article 35 to amend such criteria, where appropriate, and to include a trajectory to gradually decrease the contribution to the Union target set in Article 3(1) and to the minimum share referred to in the first subparagraph of Article 25(1), of high indirect land-use change-risk biofuels, bioliquids and biomass fuels produced from feedstock for which a significant expansion of the production into land with high-carbon stock is observed. Article 27 Calculation rules with regard to the minimum shares of renewable energy in the transport sector 1. For the calculation of the minimum shares referred to in the first and fourth subparagraphs of Article 25(1), the following provisions shall apply: (a) for the calculation of the denominator, that is the energy content of road- and rail- transport fuels supplied for consumption or use on the market, petrol, diesel, natural gas, biofuels, biogas, renewable liquid and gaseous transport fuels of non-biological origin, recycled carbon fuels and electricity supplied to the road and rail transport sectors, shall be taken into account; (b) for the calculation of the numerator, that is the amount of energy from renewable sources consumed in the transport sector for the purposes of the first subparagraph of Article 25(1), the energy content of all types of energy from renewable sources supplied to all transport sectors, including renewable electricity supplied to the road and rail transport sectors, shall be taken into account. Member States may also take into account recycled carbon fuels. For the calculation of the numerator, the share of biofuels and biogas produced from the feedstock listed in Part B of Annex IX shall, except for in Cyprus and Malta, be limited to 1,7 % of the energy content of transport fuels supplied for consumption or use on the market. Member States may, where justified, modify that limit, taking into account the availability of feedstock. Any such modification shall be subject to approval by the Commission; (c) for the calculation of both numerator and denominator, the values regarding the energy content of transport fuels set out in Annex III shall be used. For the determination of the energy content of transport fuels not included in Annex III, the Member States shall use the relevant ESO standards for the determination of the calorific values of fuels. Where no ESO standard has been adopted for that purpose, the relevant ISO standards shall be used. The Commission is empowered to adopt delegated acts in accordance with Article 35 to amend this Directive by adapting the energy content of transport fuels, as set out in Annex III, in accordance with scientific and technical progress. 2. For the purposes of demonstrating compliance with the minimum shares referred to in Article 25(1): (a) the share of biofuels and biogas for transport produced from the feedstock listed in Annex IX may be considered to be twice its energy content; (b) the share of renewable electricity shall be considered to be four times its energy content when supplied to road vehicles and may be considered to be 1,5 times its energy content when supplied to rail transport; (c) with the exception of fuels produced from food and feed crops, the share of fuels supplied in the aviation and maritime sectors shall be considered to be 1,2 times their energy content. 3. For the calculation of the share of renewable electricity in the electricity supplied to road and rail vehicles for the purposes of paragraph 1 of this Article, Member States shall refer to the two-year period before the year in which the electricity is supplied in their territory. By way of derogation from the first subparagraph of this paragraph, to determine the share of electricity for the purposes of paragraph 1 of this Article, in the case of electricity obtained from a direct connection to an installation generating renewable electricity and supplied to road vehicles, that electricity shall be fully counted as renewable. In order to ensure that the expected increase in demand for electricity in the transport sector beyond the current baseline is met with additional renewable energy generation capacity, the Commission shall develop a framework on additionality in the transport sector and shall develop different options with a view to determining the baseline of Member States and measuring additionality. For the purposes of this paragraph, where electricity is used for the production of renewable liquid and gaseous transport fuels of non-biological origin, either directly or for the production of intermediate products, the average share of electricity from renewable sources in the country of production, as measured two years before the year in question, shall be used to determine the share of renewable energy. However, electricity obtained from direct connection to an installation generating renewable electricity may be fully counted as renewable electricity where it is used for the production of renewable liquid and gaseous transport fuels of non-biological origin, provided that the installation: (a) comes into operation after, or at the same time as, the installation producing the renewable liquid and gaseous transport fuels of non-biological origin; and (b) is not connected to the grid or is connected to the grid but evidence can be provided that the electricity concerned has been supplied without taking electricity from the grid. Electricity that has been taken from the grid may be counted as fully renewable provided that it is produced exclusively from renewable sources and the renewable properties and other appropriate criteria have been demonstrated, ensuring that the renewable properties of that electricity are claimed only once and only in one end-use sector. By 31 December 2021, the Commission shall adopt a delegated act in accordance with Article 35 to supplement this Directive by establishing a Union methodology setting out detailed rules by which economic operators are to comply with the requirements laid down in the fifth and sixth subparagraphs of this paragraph. Article 28 Other provisions on renewable energy in the transport sector 1. With a view to minimising the risk of single consignments being claimed more than once in the Union, Member States and the Commission shall strengthen cooperation among national systems and between national systems and voluntary schemes and verifiers established pursuant to Article 30, including, where appropriate, the exchange of data. Where the competent authority of one Member State suspects or detects a fraud, it shall, where appropriate, inform the other Member States. 2. The Commission shall ensure that a Union database is put in place to enable the tracing of liquid and gaseous transport fuels that are eligible for being counted towards the numerator referred to in point (b) of Article 27(1) or that are taken into account for the purposes referred to in points (a), (b), and (c) of the first subparagraph of Article 29(1). Member States shall require the relevant economic operators to enter into that database information on the transactions made and the sustainability characteristics of those fuels, including their life-cycle greenhouse gas emissions, starting from their point of production to the fuel supplier that places the fuel on the market. A Member State may set up a national database that is linked to the Union database ensuring that information entered is instantly transferred between the databases. Fuel suppliers shall enter the information necessary to verify compliance with the requirements laid down in the first and fourth subparagraphs of Article 25(1) into the relevant database. 3. By 31 December 2021, Member States shall take measures to ensure the availability of fuels from renewable sources for transport including with regard to publicly accessible high-power recharging points and other refuelling infrastructure as provided for in their national policy frameworks in accordance with Directive 2014/94/EU. 4. Member States shall have access to the Union database referred to in paragraph 2 of this Article. They shall take measures to ensure that economic operators enter accurate information into the relevant database. The Commission shall require the schemes that are the subject of a decision pursuant to Article 30(4) of this Directive to verify compliance with that requirement when checking compliance with the sustainability criteria for biofuels, bioliquids and biomass fuels. It shall publish, every two years, aggregated information from the Union database pursuant to Annex VIII to Regulation (EU) 2018/1999. 5. By 31 December 2021, the Commission shall adopt delegated acts in accordance with Article 35 to supplement this Directive by specifying the methodology to determine the share of biofuel, and biogas for transport, resulting from biomass being processed with fossil fuels in a common process, and by specifying the methodology for assessing greenhouse gas emissions savings from renewable liquid and gaseous transport fuels of non-biological origin and from recycled carbon fuels, which shall ensure that credit for avoided emissions is not given for CO2 the capture of which has already received an emission credit under other provisions of law. 6. By 25 June 2019 and every two years thereafter, the Commission shall review the list of feedstock set out in Parts A and B of Annex IX with a view to adding feedstock in accordance with the principles set out in the third subparagraph. The Commission is empowered to adopt delegated acts in accordance with Article 35 to amend the list of feedstock set out in Parts A and B of Annex IX by adding, but not removing, feedstock. Feedstock that can be processed only with advanced technologies shall be added to Part A of Annex IX. Feedstock that can be processed into biofuels, or biogas for transport, with mature technologies shall be added to Part B of Annex IX. Such delegated acts shall be based on an analysis of the potential of the raw material as feedstock for the production of biofuels and biogas for transport, taking into account all of the following: (a) the principles of the circular economy and of the waste hierarchy established in Directive 2008/98/EC; (b) the Union sustainability criteria laid down in Article 29(2) to (7); (c) the need to avoid significant distortive effects on markets for (by-)products, wastes or residues; (d) the potential for delivering substantial greenhouse gas emissions savings compared to fossil fuels based on a life-cycle assessment of emissions; (e) the need to avoid negative impacts on the environment and biodiversity; (f) the need to avoid creating an additional demand for land. 7. By 31 December 2025, in the context of the biennial assessment of progress made pursuant to Regulation (EU) 2018/1999, the Commission shall assess whether the obligation relating to advanced biofuels and biogas produced from feedstock listed in Part A of Annex IX laid down in the fourth subparagraph of Article 25(1) effectively stimulates innovation and ensures greenhouse gas emissions savings in the transport sector. The Commission shall analyse in that assessment whether the application of this Article effectively avoids double accounting of renewable energy. The Commission shall, if appropriate, submit a proposal to amend the obligation relating to advanced biofuels and biogas produced from feedstock listed in Part A of Annex IX laid down in the fourth subparagraph of Article 25(1). Article 29 Sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids and biomass fuels 1. Energy from biofuels, bioliquids and biomass fuels shall be taken into account for the purposes referred to in points (a), (b) and (c) of this subparagraph only if they fulfil the sustainability and the greenhouse gas emissions saving criteria laid down in paragraphs 2 to 7 and 10: (a) contributing towards the Union target set in Article 3(1) and the renewable energy shares of Member States; (b) measuring compliance with renewable energy obligations, including the obligation laid down in Article 25; (c) eligibility for financial support for the consumption of biofuels, bioliquids and biomass fuels. However, biofuels, bioliquids and biomass fuels produced from waste and residues, other than agricultural, aquaculture, fisheries and forestry residues, are required to fulfil only the greenhouse gas emissions saving criteria laid down in paragraph 10 in order to be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph. This subparagraph shall also apply to waste and residues that are first processed into a product before being further processed into biofuels, bioliquids and biomass fuels. Electricity, heating and cooling produced from municipal solid waste shall not be subject to the greenhouse gas emissions saving criteria laid down in paragraph 10. Biomass fuels shall fulfil the sustainability and greenhouse gas emissions saving criteria laid down in paragraphs 2 to 7 and 10 if used in installations producing electricity, heating and cooling or fuels with a total rated thermal input equal to or exceeding 20 MW in the case of solid biomass fuels, and with a total rated thermal input equal to or exceeding 2 MW in the case of gaseous biomass fuels. Member States may apply the sustainability and greenhouse gas emissions saving criteria to installations with lower total rated thermal input. The sustainability and the greenhouse gas emissions saving criteria laid down in paragraphs 2 to 7 and 10 shall apply irrespective of the geographical origin of the biomass. 2. Biofuels, bioliquids and biomass fuels produced from waste and residues derived not from forestry but from agricultural land shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 only where operators or national authorities have monitoring or management plans in place in order to address the impacts on soil quality and soil carbon. Information about how those impacts are monitored and managed shall be reported pursuant to Article 30(3). 3. Biofuels, bioliquids and biomass fuels produced from agricultural biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be made from raw material obtained from land with a high biodiversity value, namely land that had one of the following statuses in or after January 2008, whether or not the land continues to have that status: (a) primary forest and other wooded land, namely forest and other wooded land of native species, where there is no clearly visible indication of human activity and the ecological processes are not significantly disturbed; (b) highly biodiverse forest and other wooded land which is species-rich and not degraded, or has been identified as being highly biodiverse by the relevant competent authority, unless evidence is provided that the production of that raw material did not interfere with those nature protection purposes; (c) areas designated: (i) by law or by the relevant competent authority for nature protection purposes; or (ii) for the protection of rare, threatened or endangered ecosystems or species recognised by international agreements or included in lists drawn up by intergovernmental organisations or the International Union for the Conservation of Nature, subject to their recognition in accordance with the first subparagraph of Article 30(4), unless evidence is provided that the production of that raw material did not interfere with those nature protection purposes; (d) highly biodiverse grassland spanning more than one hectare that is: (i) natural, namely grassland that would remain grassland in the absence of human intervention and that maintains the natural species composition and ecological characteristics and processes; or (ii) non-natural, namely grassland that would cease to be grassland in the absence of human intervention and that is species-rich and not degraded and has been identified as being highly biodiverse by the relevant competent authority, unless evidence is provided that the harvesting of the raw material is necessary to preserve its status as highly biodiverse grassland. The Commission may adopt implementing acts further specifying the criteria by which to determine which grassland are to be covered by point (d) of the first subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). 4. Biofuels, bioliquids and biomass fuels produced from agricultural biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be made from raw material obtained from land with high-carbon stock, namely land that had one of the following statuses in January 2008 and no longer has that status: (a) wetlands, namely land that is covered with or saturated by water permanently or for a significant part of the year; (b) continuously forested areas, namely land spanning more than one hectare with trees higher than five metres and a canopy cover of more than 30 %, or trees able to reach those thresholds in situ; (c) land spanning more than one hectare with trees higher than five metres and a canopy cover of between 10 % and 30 %, or trees able to reach those thresholds in situ, unless evidence is provided that the carbon stock of the area before and after conversion is such that, when the methodology laid down in Part C of Annex V is applied, the conditions laid down in paragraph 10 of this Article would be fulfilled. This paragraph shall not apply if, at the time the raw material was obtained, the land had the same status as it had in January 2008. 5. Biofuels, bioliquids and biomass fuels produced from agricultural biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be made from raw material obtained from land that was peatland in January 2008, unless evidence is provided that the cultivation and harvesting of that raw material does not involve drainage of previously undrained soil. 6. Biofuels, bioliquids and biomass fuels produced from forest biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall meet the following criteria to minimise the risk of using forest biomass derived from unsustainable production: (a) the country in which forest biomass was harvested has national or sub-national laws applicable in the area of harvest as well as monitoring and enforcement systems in place ensuring: (i) the legality of harvesting operations; (ii) forest regeneration of harvested areas; (iii) that areas designated by international or national law or by the relevant competent authority for nature protection purposes, including in wetlands and peatlands, are protected; (iv) that harvesting is carried out considering maintenance of soil quality and biodiversity with the aim of minimising negative impacts; and (v) that harvesting maintains or improves the long-term production capacity of the forest; (b) when evidence referred to in point (a) of this paragraph is not available, the biofuels, bioliquids and biomass fuels produced from forest biomass shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 if management systems are in place at forest sourcing area level ensuring: (i) the legality of harvesting operations; (ii) forest regeneration of harvested areas; (iii) that areas designated by international or national law or by the relevant competent authority for nature protection purposes, including in wetlands and peatlands, are protected unless evidence is provided that the harvesting of that raw material does not interfere with those nature protection purposes; (iv) that harvesting is carried out considering the maintenance of soil quality and biodiversity with the aim of minimising negative impacts; and (v) that harvesting maintains or improves the long-term production capacity of the forest. 7. Biofuels, bioliquids and biomass fuels produced from forest biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall meet the following land-use, land-use change and forestry (LULUCF) criteria: (a) the country or regional economic integration organisation of origin of the forest biomass: (i) is a Party to the Paris Agreement; (ii) has submitted a nationally determined contribution (NDC) to the United Nations Framework Convention on Climate Change (UNFCCC), covering emissions and removals from agriculture, forestry and land use which ensures that changes in carbon stock associated with biomass harvest are accounted towards the country's commitment to reduce or limit greenhouse gas emissions as specified in the NDC; or (iii) has national or sub-national laws in place, in accordance with Article 5 of the Paris Agreement, applicable in the area of harvest, to conserve and enhance carbon stocks and sinks, and providing evidence that reported LULUCF-sector emissions do not exceed removals; (b) where evidence referred to in point (a) of this paragraph is not available, the biofuels, bioliquids and biomass fuels produced from forest biomass shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 if management systems are in place at forest sourcing area level to ensure that carbon stocks and sinks levels in the forest are maintained, or strengthened over the long term. 8. By 31 January 2021, the Commission shall adopt implementing acts establishing the operational guidance on the evidence for demonstrating compliance with the criteria laid down in paragraphs 6 and 7 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). 9. By 31 December 2026, the Commission shall assess whether the criteria laid down in paragraphs 6 and 7 effectively minimise the risk of using forest biomass derived from unsustainable production and address LULUCF criteria, on the basis of the available data. The Commission shall, if appropriate, submit a legislative proposal to amend the criteria laid down in paragraphs 6 and 7 for the period after 2030. 10. The greenhouse gas emission savings from the use of biofuels, bioliquids and biomass fuels taken into account for the purposes referred to in paragraph 1 shall be: (a) at least 50 % for biofuels, biogas consumed in the transport sector, and bioliquids produced in installations in operation on or before 5 October 2015; (b) at least 60 % for biofuels, biogas consumed in the transport sector, and bioliquids produced in installations starting operation from 6 October 2015 until 31 December 2020; (c) at least 65 % for biofuels, biogas consumed in the transport sector, and bioliquids produced in installations starting operation from 1 January 2021; (d) at least 70 % for electricity, heating and cooling production from biomass fuels used in installations starting operation from 1 January 2021 until 31 December 2025, and 80 % for installations starting operation from 1 January 2026. An installation shall be considered to be in operation once the physical production of biofuels, biogas consumed in the transport sector and bioliquids, and the physical production of heating and cooling and electricity from biomass fuels has started. The greenhouse gas emission savings from the use of biofuels, biogas consumed in the transport sector, bioliquids and biomass fuels used in installations producing heating, cooling and electricity shall be calculated in accordance with Article 31(1). 11. Electricity from biomass fuels shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 only if it meets one or more of the following requirements: (a) it is produced in installations with a total rated thermal input below 50 MW; (b) for installations with a total rated thermal input from 50 to 100 MW, it is produced applying high-efficiency cogeneration technology, or, for electricity-only installations, meeting an energy efficiency level associated with the best available techniques (BAT-AEELs) as defined in Commission Implementing Decision (EU) 2017/1442 (26); (c) for installations with a total rated thermal input above 100 MW, it is produced applying high-efficiency cogeneration technology, or, for electricity-only installations, achieving an net-electrical efficiency of at least 36 %; (d) it is produced applying Biomass CO2 Capture and Storage. For the purposes of points (a), (b) and (c) of the first subparagraph of paragraph 1 of this Article, electricity-only-installations shall be taken into account only if they do not use fossil fuels as a main fuel and only if there is no cost-effective potential for the application of high-efficiency cogeneration technology according to the assessment in accordance with Article 14 of Directive 2012/27/EU. For the purposes of points (a) and (b) of the first subparagraph of paragraph 1 of this Article, this paragraph shall apply only to installations starting operation or converted to the use of biomass fuels after 25 December 2021. For the purposes of point (c) of the first subparagraph of paragraph 1 of this Article, this paragraph shall be without prejudice to support granted under support schemes in accordance with Article 4 approved by 25 December 2021. Member States may apply higher energy efficiency requirements than those referred in the first subparagraph to installations with lower rated thermal input. The first subparagraph shall not apply to electricity from installations which are the object of a specific notification by a Member State to the Commission based on the duly substantiated existence of risks for the security of supply of electricity. Upon assessment of the notification, the Commission shall adopt a decision taking into account the elements included therein. 12. For the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 of this Article, and without prejudice to Articles 25 and 26, Member States shall not refuse to take into account, on other sustainability grounds, biofuels and bioliquids obtained in compliance with this Article. This paragraph shall be without prejudice to public support granted under support schemes approved before 24 December 2018. 13. For the purposes referred to in point (c) of the first subparagraph of paragraph 1 of this Article, Member States may derogate, for a limited period of time, from the criteria laid down in paragraphs 2 to 7 and 10 and 11 of this Article by adopting different criteria for: (a) installations located in an outermost region as referred to in Article 349 TFEU to the extent that such facilities produce electricity or heating or cooling from biomass fuels; and (b) biomass fuels used in the installations referred to in point (a) of this subparagraph, irrespective of the place of origin of that biomass, provided that such criteria are objectively justified on the grounds that their aim is to ensure, for that outermost region, a smooth phase-in of the criteria laid down in paragraphs 2 to 7 and 10 and 11 of this Article and thereby incentivise the transition from fossil fuels to sustainable biomass fuels. The different criteria referred to in this paragraph shall be subject to a specific notification by the relevant Member State to the Commission. 14. For the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1, Member States may establish additional sustainability criteria for biomass fuels. By 31 December 2026, the Commission shall assess the impact of such additional criteria on the internal market, accompanied, if necessary, by a proposal to ensure harmonisation thereof. Article 30 Verification of compliance with the sustainability and greenhouse gas emissions saving criteria 1. Where biofuels, bioliquids and biomass fuels, or other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1), are to be taken into account for the purposes referred to in Articles 23 and 25 and in points (a), (b) and (c) of the first subparagraph of Article 29(1), Member States shall require economic operators to show that the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) have been fulfilled. For those purposes, they shall require economic operators to use a mass balance system which: (a) allows consignments of raw material or fuels with differing sustainability and greenhouse gas emissions saving characteristics to be mixed for instance in a container, processing or logistical facility, transmission and distribution infrastructure or site; (b) allows consignments of raw material with differing energy content to be mixed for the purposes of further processing, provided that the size of consignments is adjusted according to their energy content; (c) requires information about the sustainability and greenhouse gas emissions saving characteristics and sizes of the consignments referred to in point (a) to remain assigned to the mixture; and (d) provides for the sum of all consignments withdrawn from the mixture to be described as having the same sustainability characteristics, in the same quantities, as the sum of all consignments added to the mixture and requires that this balance be achieved over an appropriate period of time. The mass balance system shall ensure that each consignment is counted only once in point (a), (b) or (c) of the first subparagraph of Article 7(1) for the purposes of calculating the gross final consumption of energy from renewable sources and shall include information on whether support has been provided for the production of that consignment, and if so, on the type of support scheme. 2. Where a consignment is processed, information on the sustainability and greenhouse gas emissions saving characteristics of the consignment shall be adjusted and assigned to the output in accordance with the following rules: (a) when the processing of a consignment of raw material yields only one output that is intended for the production of biofuels, bioliquids or biomass fuels, renewable liquid and gaseous transport fuels of non-biological origin, or recycled carbon fuels, the size of the consignment and the related quantities of sustainability and greenhouse gas emissions saving characteristics shall be adjusted applying a conversion factor representing the ratio between the mass of the output that is intended for such production and the mass of the raw material entering the process; (b) when the processing of a consignment of raw material yields more than one output that is intended for the production of biofuels, bioliquids or biomass fuels, renewable liquid and gaseous transport fuels of non-biological origin, or recycled carbon fuels, for each output a separate conversion factor shall be applied and a separate mass balance shall be used. 3. Member States shall take measures to ensure that economic operators submit reliable information regarding the compliance with the greenhouse gas emissions savings thresholds set in, and adopted pursuant to, Article 25(2), and with the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10), and that economic operators make available to the relevant Member State, upon request, the data that were used to develop the information. Member States shall require economic operators to arrange for an adequate standard of independent auditing of the information submitted, and to provide evidence that this has been done. In order to comply with point (a) of Article 29(6) and point (a) of Article 29(7), the first or second party auditing may be used up to the first gathering point of the forest biomass. The auditing shall verify that the systems used by economic operators are accurate, reliable and protected against fraud, including verification ensuring that materials are not intentionally modified or discarded so that the consignment or part thereof could become a waste or residue. It shall evaluate the frequency and methodology of sampling and the robustness of the data. The obligations laid down in this paragraph shall apply regardless of whether the biofuels, bioliquids, biomass fuels, renewable liquid and gaseous transport fuels of non-biological origin, or recycled carbon fuels are produced within the Union or are imported. Information about the geographic origin and feedstock type of biofuels, bioliquids and biomass fuels per fuel supplier shall be made available to consumers on the websites of operators, suppliers or the relevant competent authorities and shall be updated on an annual basis. Member States shall submit to the Commission, in aggregated form, the information referred to in the first subparagraph of this paragraph. The Commission shall publish that information on the e-reporting platform referred to in Article 28 of Regulation (EU) 2018/1999 in summary form preserving the confidentiality of commercially sensitive information. 4. The Commission may decide that voluntary national or international schemes setting standards for the production of biofuels, bioliquids or biomass fuels, or other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1), provide accurate data on greenhouse gas emission savings for the purposes of Article 25(2) and Article 29(10), demonstrate compliance with Article 27(3) and Article 28(2) and (4), or demonstrate that consignments of biofuels, bioliquids or biomass fuels comply with the sustainability criteria laid down in Article 29(2) to (7). When demonstrating that the criteria laid down in Article 29(6) and (7) are met, the operators may provide the required evidence directly at sourcing area level. The Commission may recognise areas for the protection of rare, threatened or endangered ecosystems or species recognised by international agreements or included in lists drawn up by intergovernmental organisations or the International Union for the Conservation of Nature for the purposes of point (c)(ii) of the first subparagraph of Article 29(3). The Commission may decide that those schemes contain accurate information on measures taken for soil, water and air protection, for the restoration of degraded land, for the avoidance of excessive water consumption in areas where water is scarce, and for certification of biofuels, bioliquids and biomass fuels with low indirect land-use change-risk. 5. The Commission shall adopt decisions under paragraph 4 of this Article by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). Such decisions shall be valid for a period of no more than five years. The Commission shall require that each voluntary scheme on which a decision has been adopted under paragraph 4 submit annually by 30 April a report to the Commission covering each of the points set out in Annex IX to Regulation (EU) 2018/1999. The report shall cover the preceding calendar year. The requirement to submit a report shall apply only to voluntary schemes that have operated for at least 12 months. The Commission shall make the reports drawn up by the voluntary schemes available, in an aggregated form or in full if appropriate, on the e-reporting platform referred to in Article 28 of Regulation (EU) 2018/1999. 6. Member States may set up national schemes where compliance with the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) and with the greenhouse gas emissions savings thresholds for renewable liquid and gaseous transport fuels of non-biological origin and recycled carbon fuels set in, and adopted pursuant to, Article 25(2) and in accordance with Article 28(5) is verified throughout the entire chain of custody involving competent national authorities. A Member State may notify such a national scheme to the Commission. The Commission shall give priority to the assessment of such a scheme in order to facilitate mutual bilateral and multilateral recognition of schemes for verification of compliance with the sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids and biomass fuels and with the greenhouse gas emissions savings thresholds for other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1). The Commission may decide, by means of implementing acts, whether such a notified national scheme complies with the conditions laid down in this Directive. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). Where the decision is positive, schemes established in accordance with this Article shall not refuse mutual recognition with that Member State's scheme, as regards verification of compliance with the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) and the greenhouse gas emissions savings thresholds set in, and adopted pursuant to, Article 25(2). 7. The Commission shall adopt decisions under paragraph 4 of this Article only if the scheme in question meets adequate standards of reliability, transparency and independent auditing and provides adequate assurances that no materials have been intentionally modified or discarded so that the consignment or part thereof would fall under Annex IX. In the case of schemes to measure greenhouse gas emissions savings, such schemes shall also comply with the methodological requirements set out in Annex V or VI. Lists of areas of high biodiversity value as referred to in point (c)(ii) of the first subparagraph of Article 29(3) shall meet adequate standards of objectivity and coherence with internationally recognised standards and provide for appropriate appeal procedures. The voluntary schemes referred to in paragraph 4 shall, at least annually, publish a list of their certification bodies used for independent auditing, indicating for each certification body by which entity or national public authority it was recognised and which entity or national public authority is monitoring it. 8. In order to ensure that compliance with the sustainability and greenhouse gas emissions saving criteria as well as with the provisions on low or high direct and indirect land-use change-risk biofuels, bioliquids and biomass fuels is verified in an efficient and harmonised manner and in particular to prevent fraud, the Commission shall adopt implementing acts specifying detailed implementing rules, including adequate standards of reliability, transparency and independent auditing and require all voluntary schemes to apply those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). In those implementing acts, the Commission shall pay particular attention to the need to minimise administrative burden. The implementing acts shall set a time frame by which voluntary schemes are required to implement the standards. The Commission may repeal decisions recognising voluntary schemes pursuant to paragraph 4 in the event that those schemes fail to implement such standards in the time frame provided for. Where a Member State raises concerns that a voluntary scheme does not operate in accordance with the standards of reliability, transparency and independent auditing that constitute the basis for decisions under paragraph 4, the Commission shall investigate the matter and take appropriate action. 9. Where an economic operator provides evidence or data obtained in accordance with a scheme that has been the subject of a decision pursuant to paragraph 4 or 6 of this Article, to the extent covered by that decision, a Member State shall not require the supplier to provide further evidence of compliance with the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10). Competent authorities of the Member States shall supervise the operation of certification bodies that are conducting independent auditing under a voluntary scheme. Certification bodies shall submit, upon the request of competent authorities, all relevant information necessary to supervise the operation, including the exact date, time and location of audits. Where Member States find issues of non-conformity, they shall inform the voluntary scheme without delay. 10. At the request of a Member State, which may be based on the request of an economic operator, the Commission shall, on the basis of all available evidence, examine whether the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) in relation to a source of biofuels, bioliquids and biomass fuels, and the greenhouse gas emissions savings thresholds set in, and adopted pursuant to, Article 25(2), have been met. Within six months of receipt of such a request and in accordance with the examination procedure referred to in Article 34(3), the Commission shall, by means of implementing acts, decide whether the Member State concerned may either: (a) take into account biofuels, bioliquids, biomass fuels and other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1) from that source for the purposes referred to in points (a), (b) and (c) of the first subparagraph of Article 29(1); or (b) by way of derogation from paragraph 9 of this Article, require suppliers of the source of biofuels, bioliquids, biomass fuels and other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1) to provide further evidence of compliance with those sustainability and greenhouse gas emissions saving criteria and those greenhouse gas emissions savings thresholds. Article 31 Calculation of the greenhouse gas impact of biofuels, bioliquids and biomass fuels 1. For the purposes of Article 29(10), the greenhouse gas emissions saving from the use of biofuel, bioliquids and biomass fuels shall be calculated in one of the following ways: (a) where a default value for greenhouse gas emissions saving for the production pathway is laid down in Part A or B of Annex V for biofuels and bioliquids and in Part A of Annex VI for biomass fuels where the el value for those biofuels or bioliquids calculated in accordance with point 7 of Part C of Annex V and for those biomass fuels calculated in accordance with point 7 of Part B of Annex VI is equal to or less than zero, by using that default value; (b) by using an actual value calculated in accordance with the methodology laid down in Part C of Annex V for biofuels and bioliquids and in Part B of Annex VI for biomass fuels; (c) by using a value calculated as the sum of the factors of the formulas referred to in point 1 of Part C of Annex V, where disaggregated default values in Part D or E of Annex V may be used for some factors, and actual values, calculated in accordance with the methodology laid down in Part C of Annex V, are used for all other factors; (d) by using a value calculated as the sum of the factors of the formulas referred to in point 1 of Part B of Annex VI, where disaggregated default values in Part C of Annex VI may be used for some factors, and actual values, calculated in accordance with the methodology laid down in Part B of Annex VI, are used for all other factors. 2. Member States may submit to the Commission reports including information on the typical greenhouse gas emissions from the cultivation of agricultural raw materials of the areas on their territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS) or as a more disaggregated NUTS level in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council (27). Those reports shall be accompanied by a description of the method and data sources used to calculate the level of emissions. That method shall take into account soil characteristics, climate and expected raw material yields. 3. In the case of territories outside the Union, reports equivalent to those referred to in paragraph 2 and drawn up by competent bodies may be submitted to the Commission. 4. The Commission may, by means of implementing acts, decide that the reports referred to in paragraphs 2 and 3 of this Article contain accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of agriculture biomass feedstock produced in the areas included in such reports for the purposes of Article 29(10). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). Those data may, pursuant to such decisions, be used instead of the disaggregated default values for cultivation laid down in Part D or E of Annex V for biofuels and bioliquids and in Part C of Annex VI for biomass fuels. 5. The Commission shall review Annexes V and VI with a view, where justified, to adding or revising values for biofuel, bioliquid and biomass fuel production pathways. Those reviews shall also consider modifying the methodology laid down in Part C of Annex V and in Part B of Annex VI. The Commission is empowered to adopt delegated acts pursuant to Article 35 to amend, where appropriate, Annexes V and VI by adding or revising the default values or modifying the methodology. In the case of an adaptation of, or addition to, the list of default values in Annexes V and VI: (a) where the contribution of a factor to overall emissions is small, where there is limited variation, or where the cost or difficulty of establishing actual values is high, the default values shall be typical of normal production processes; (b) in all other cases, the default values shall be conservative compared to normal production processes. 6. Where necessary in order to ensure the uniform application of Part C of Annex V and Part B of Annex VI, the Commission may adopt implementing acts setting out detailed technical specifications including definitions, conversion factors, the calculation of annual cultivation emissions or emission savings caused by changes above and below-ground carbon stocks on already cultivated land, the calculation of emission savings from CO2 capture, CO2 replacement and CO2 geological storage. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). Article 32 Implementing acts The implementing acts referred to in the second subparagraph of Article 29(3), Article 29(8), the first subparagraph of Article 30(5), the second subparagraph of Article 30(6), the first subparagraph of Article 30(8), the first subparagraph of Article 31(4) and Article 31(6) of this Directive, shall take full account of the provisions relating to greenhouse gas emissions reductions in accordance with Article 7a of Directive 98/70/EC of the European Parliament and of the Council (28). Article 33 Monitoring by the Commission 1. The Commission shall monitor the origin of biofuels, bioliquids and biomass fuels consumed in the Union and the impact of their production, including the impact as a result of displacement, on land use in the Union and in the main third countries of supply. Such monitoring shall be based on Member States' integrated national energy and climate plans and corresponding progress reports pursuant to Articles 3, 17 and 20 of Regulation (EU) 2018/1999, and those of relevant third countries, intergovernmental organisations, scientific studies and any other relevant pieces of information. The Commission shall also monitor the commodity price changes associated with the use of biomass for energy and any associated positive and negative effects on food security. 2. The Commission shall maintain a dialogue and exchange information with third countries and biofuel, bioliquid and biomass fuel producers, consumer organisations and civil society concerning the general implementation of the measures in this Directive relating to biofuels, bioliquids and biomass fuels. It shall, within that framework, pay particular attention to the impact that biofuel, bioliquid and biomass fuel production may have on food prices. 3. In 2026, the Commission shall submit, if appropriate, a legislative proposal on the regulatory framework for the promotion of energy from renewable sources for the period after 2030. That proposal shall take into account the experience of the implementation of this Directive, including its sustainability and greenhouse gas emissions saving criteria, and technological developments in energy from renewable sources. 4. In 2032, the Commission shall publish a report reviewing the application of this Directive. Article 34 Committee procedure 1. The Commission shall be assisted by the Energy Union Committee established by Article 44 of Regulation (EU) 2018/1999. 2. Notwithstanding paragraph 1, for matters relating to the sustainability of biofuels, bioliquids and biomass fuels, the Commission shall be assisted by the Committee on the Sustainability of Biofuels, Bioliquids and Biomass fuels. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 35 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in the second subparagraph of Article 8(3), the second subparagraph of Article 25(2), the fourth subparagraph of Article 26(2), the fifth subparagraph of Article 26(2), point (c) of Article 27(1), the seventh subparagraph of Article 27(3), Article 28(5), the second subparagraph of Article 28(6), and the second subparagraph of Article 31(5) shall be conferred on the Commission for a period of five years from 24 December 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The power to adopt delegated acts referred to in the fifth subparagraph of Article 7(3) shall be conferred on the Commission for a period of two years from 24 December 2018. 4. The delegation of power referred to in the fifth subparagraph of Article 7(3), the second subparagraph of Article 8(3), the second subparagraph of Article 25(2), the fourth subparagraph of Article 26(2), the fifth subparagraph of Article 26(2), point (c) of Article 27(1), the seventh subparagraph of Article 27(3), Article 28(5), the second subparagraph of Article 28(6), and the second subparagraph of Article 31(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 6. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 7. A delegated act adopted pursuant to the fifth subparagraph of Article 7(3), the second subparagraph of Article 8(3), the second subparagraph of Article 25(2), the fourth subparagraph of Article 26(2), the fifth subparagraph of Article 26(2), point (c) of Article 27(1), the seventh subparagraph of Article 27(3), Article 28(5), the second subparagraph of Article 28(6), and the second subparagraph of Article 31(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 36 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Articles 2 to 13, 15 to 31 and 37 and Annexes II, III and V to IX, by 30 June 2021. They shall immediately communicate the text of those measures to the Commission. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. 3. This Directive shall not affect the application of the derogations pursuant to Union law on the internal market for electricity. Article 37 Repeal Directive 2009/28/EC, as amended by the Directives listed in Part A of Annex X, is repealed with effect from 1 July 2021, without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law of the Directives set out in Part B of Annex X and without prejudice to the obligations of Member States in 2020 as laid down in Article 3(1) and set out in Part A of Annex I to Directive 2009/28/EC. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex XI. Article 38 Entry into force This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 39 Addressees This Directive is addressed to the Member States. Done at Strasbourg, 11 December 2018. For the European Parliament The President A. TAJANI For the Council The President J. BOGNER-STRAUSS (1) OJ C 246, 28.7.2017, p. 55. (2) OJ C 342, 12.10.2017, p. 79. (3) Position of the European Parliament of 13 November 2018 (not yet published in the Official Journal) and decision of the Council of 4 December 2018. (4) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, p. 16). (5) See Annex X, Part A. (6) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (see page 1 of this Official Journal). (7) Regulation (EC) No 1099/2008 of the European Parliament and of the Council of 22 October 2008 on energy statistics (OJ L 304, 14.11.2008, p. 1). (8) Directive 2001/77/EC of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market (OJ L 283, 27.10.2001, p. 33). (9) Directive 2003/30/EC of the European Parliament and of the Council of 8 May 2003 on the promotion of the use of biofuels or other renewable fuels for transport (OJ L 123, 17.5.2003, p. 42). (10) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). (11) OJ L 198, 20.7.2006, p. 18. (12) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1). (13) Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22). (14) Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13). (15) Directive (EU) 2015/1513 of the European Parliament and of the Council of 9 September 2015 amending Directive 98/70/EC relating to the quality of petrol and diesel fuels and amending Directive 2009/28/EC on the promotion of the use of energy from renewable sources (OJ L 239, 15.9.2015, p. 1). (16) Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13). (17) Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). (18) OJ L 123, 12.5.2016, p. 1. (19) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (20) OJ C 369, 17.12.2011, p. 14. (21) Council Directive 2013/18/EU of 13 May 2013 adapting Directive 2009/28/EC of the European Parliament and of the Council on the promotion of the use of energy from renewable sources, by reason of the accession of the Republic of Croatia (OJ L 158, 10.6.2013, p. 230). (22) Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJ L 211, 14.8.2009, p. 55). (23) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (24) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (25) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94). (26) Commission Implementing Decision (EU) 2017/1442 of 31 July 2017 establishing best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council, for large combustion plants (OJ L 212, 17.8.2017, p. 1). (27) Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1). (28) Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58). ANNEX I NATIONAL OVERALL TARGETS FOR THE SHARE OF ENERGY FROM RENEWABLE SOURCES IN GROSS FINAL CONSUMPTION OF ENERGY IN 2020 (1) A. National overall targets Share of energy from renewable sources in gross final consumption of energy, 2005 (S2005) Target for share of energy from renewable sources in gross final consumption of energy, 2020 (S2020) Belgium 2,2 % 13 % Bulgaria 9,4 % 16 % Czech Republic 6,1 % 13 % Denmark 17,0 % 30 % Germany 5,8 % 18 % Estonia 18,0 % 25 % Ireland 3,1 % 16 % Greece 6,9 % 18 % Spain 8,7 % 20 % France 10,3 % 23 % Croatia 12,6 % 20 % Italy 5,2 % 17 % Cyprus 2,9 % 13 % Latvia 32,6 % 40 % Lithuania 15,0 % 23 % Luxembourg 0,9 % 11 % Hungary 4,3 % 13 % Malta 0,0 % 10 % Netherlands 2,4 % 14 % Austria 23,3 % 34 % Poland 7,2 % 15 % Portugal 20,5 % 31 % Romania 17,8 % 24 % Slovenia 16,0 % 25 % Slovak Republic 6,7 % 14 % Finland 28,5 % 38 % Sweden 39,8 % 49 % United Kingdom 1,3 % 15 % (1) In order to be able to achieve the national objectives set out in this Annex, it is underlined that the State aid guidelines for environmental protection recognise the continued need for national mechanisms of support for the promotion of energy from renewable sources. ANNEX II NORMALISATION RULE FOR ACCOUNTING FOR ELECTRICITY GENERATED FROM HYDROPOWER AND WIND POWER The following rule shall be applied for the purposes of accounting for electricity generated from hydropower in a given Member State: (QN(norm))(CN[(/(i)(N 14))(QiCi)] 15) where: N = reference year; QN(norm) = normalised electricity generated by all hydropower plants of the Member State in year N, for accounting purposes; Qi = the quantity of electricity actually generated in year i by all hydropower plants of the Member State measured in GWh, excluding production from pumped storage units using water that has previously been pumped uphill; Ci = the total installed capacity, net of pumped storage, of all hydropower plants of the Member State at the end of year i, measured in MW. The following rule shall be applied for the purposes of accounting for electricity generated from onshore wind power in a given Member State: (QN(norm))((CN CN 12)((/(i)(Nn))Qi(/(j)(Nn))(Cj Cj 12))) where: N = reference year; QN(norm) = normalised electricity generated by all onshore wind power plants of the Member State in year N, for accounting purposes; Qi = the quantity of electricity actually generated in year i by all onshore wind power plants of the Member State measured in GWh; Cj = the total installed capacity of all the onshore wind power plants of the Member State at the end of year j, measured in MW; n = 4 or the number of years preceding year N for which capacity and production data are available for the Member State in question, whichever is lower. The following rule shall be applied for the purposes of accounting for electricity generated from offshore wind power in a given Member State: (QN(norm))((CN CN 12)((/(i)(Nn))Qi(/(j)(Nn))(Cj Cj 12))) where: N = reference year; QN(norm) = normalised electricity generated by all offshore wind power plants of the Member State in year N, for accounting purposes; Qi = the quantity of electricity actually generated in year i by all offshore wind power plants of the Member State measured in GWh; Cj = the total installed capacity of all the offshore wind power plants of the Member State at the end of year j, measured in MW; n = 4 or the number of years preceding year N for which capacity and production data are available for the Member State in question, whichever is lower. ANNEX III ENERGY CONTENT OF FUELS Fuel Energy content by weight (lower calorific value, MJ/kg) Energy content by volume (lower calorific value, MJ/l) FUELS FROM BIOMASS AND/OR BIOMASS PROCESSING OPERATIONS Bio-Propane 46 24 Pure vegetable oil (oil produced from oil plants through pressing, extraction or comparable procedures, crude or refined but chemically unmodified) 37 34 Biodiesel - fatty acid methyl ester (methyl-ester produced from oil of biomass origin) 37 33 Biodiesel - fatty acid ethyl ester (ethyl-ester produced from oil of biomass origin) 38 34 Biogas that can be purified to natural gas quality 50 \u2014 Hydrotreated (thermochemically treated with hydrogen) oil of biomass origin, to be used for replacement of diesel 44 34 Hydrotreated (thermochemically treated with hydrogen) oil of biomass origin, to be used for replacement of petrol 45 30 Hydrotreated (thermochemically treated with hydrogen) oil of biomass origin, to be used for replacement of jet fuel 44 34 Hydrotreated oil (thermochemically treated with hydrogen) of biomass origin, to be used for replacement of liquefied petroleum gas 46 24 Co-processed oil (processed in a refinery simultaneously with fossil fuel) of biomass or pyrolysed biomass origin to be used for replacement of diesel 43 36 Co-processed oil (processed in a refinery simultaneously with fossil fuel) of biomass or pyrolysed biomass origin, to be used to replace petrol 44 32 Co-processed oil (processed in a refinery simultaneously with fossil fuel) of biomass or pyrolysed biomass origin, to be used to replace jet fuel 43 33 Co-processed oil (processed in a refinery simultaneously with fossil fuel) of biomass or pyrolysed biomass origin, to be used to replace liquefied petroleum gas 46 23 RENEWABLE FUELS THAT CAN BE PRODUCED FROM VARIOUS RENEWABLE SOURCES, INCLUDING BIOMASS Methanol from renewable sources 20 16 Ethanol from renewable sources 27 21 Propanol from renewable sources 31 25 Butanol from renewable sources 33 27 Fischer-Tropsch diesel (a synthetic hydrocarbon or mixture of synthetic hydrocarbons to be used for replacement of diesel) 44 34 Fischer-Tropsch petrol (a synthetic hydrocarbon or mixture of synthetic hydrocarbons produced from biomass, to be used for replacement of petrol) 44 33 Fischer-Tropsch jet fuel (a synthetic hydrocarbon or mixture of synthetic hydrocarbons produced from biomass, to be used for replacement of jet fuel) 44 33 Fischer-Tropsch liquefied petroleum gas (a synthetic hydrocarbon or mixture of synthetic hydrocarbons, to be used for replacement of liquefied petroleum gas 46 24 DME (dimethylether) 28 19 Hydrogen from renewable sources 120 \u2014 ETBE (ethyl-tertio-butyl-ether produced on the basis of ethanol) 36 (of which 37 % from renewable sources) 27 (of which 37 % from renewable sources) MTBE (methyl-tertio-butyl-ether produced on the basis of methanol) 35 (of which 22 % from renewable sources) 26 (of which 22 % from renewable sources) TAEE (tertiary-amyl-ethyl-ether produced on the basis of ethanol) 38 (of which 29 % from renewable sources) 29 (of which 29 % from renewable sources) TAME (tertiary-amyl-methyl-ether produced on the basis of methanol) 36 (of which 18 % from renewable sources) 28 (of which 18 % from renewable sources) THxEE (tertiary-hexyl-ethyl-ether produced on the basis of ethanol) 38 (of which 25 % from renewable sources) 30 (of which 25 % from renewable sources) THxME (tertiary-hexyl-methyl-ether produced on the basis of methanol) 38 of which 14 % from renewable sources) 30 (of which 14 % from renewable sources) FOSSIL FUELS Petrol 43 32 Diesel 43 36 ANNEX IV CERTIFICATION OF INSTALLERS The certification schemes or equivalent qualification schemes referred to in Article 18(3) shall be based on the following criteria: 1. The certification or qualification process shall be transparent and clearly defined by the Member States or by the administrative body that they appoint. 2. Installers of biomass, heat pump, shallow geothermal and solar photovoltaic and solar thermal energy shall be certified by an accredited training programme or training provider. 3. The accreditation of the training programme or provider shall be effected by Member States or by the administrative body that they appoint. The accrediting body shall ensure that the training programme offered by the training provider has continuity and regional or national coverage. The training provider shall have adequate technical facilities to provide practical training, including some laboratory equipment or corresponding facilities to provide practical training. The training provider shall also offer in addition to the basic training, shorter refresher courses on topical issues, including on new technologies, to enable life-long learning in installations. The training provider may be the manufacturer of the equipment or system, institutes or associations. 4. The training leading to certification or qualification of an installer shall include theoretical and practical parts. At the end of the training, the installer must have the skills required to install the relevant equipment and systems to meet the performance and reliability needs of the customer, incorporate quality craftsmanship, and comply with all applicable codes and standards, including energy and eco-labelling. 5. The training course shall end with an examination leading to a certificate or qualification. The examination shall include a practical assessment of successfully installing biomass boilers or stoves, heat pumps, shallow geothermal installations, solar photovoltaic or solar thermal installations. 6. The certification schemes or equivalent qualification schemes referred to in Article 18(3) shall take due account of the following guidelines: (a) Accredited training programmes should be offered to installers with work experience, who have undergone, or are undergoing, the following types of training: (i) in the case of biomass boiler and stove installers: training as a plumber, pipe fitter, heating engineer or technician of sanitary and heating or cooling equipment as a prerequisite; (ii) in the case of heat pump installers: training as a plumber or refrigeration engineer and have basic electrical and plumbing skills (cutting pipe, soldering pipe joints, gluing pipe joints, lagging, sealing fittings, testing for leaks and installation of heating or cooling systems) as a prerequisite; (iii) in the case of a solar photovoltaic or solar thermal installer: training as a plumber or electrician and have plumbing, electrical and roofing skills, including knowledge of soldering pipe joints, gluing pipe joints, sealing fittings, testing for plumbing leaks, ability to connect wiring, familiar with basic roof materials, flashing and sealing methods as a prerequisite; or (iv) a vocational training scheme to provide an installer with adequate skills corresponding to a three years education in the skills referred to in point (a), (b) or (c), including both classroom and workplace learning. (b) The theoretical part of the biomass stove and boiler installer training should give an overview of the market situation of biomass and cover ecological aspects, biomass fuels, logistics, fire protection, related subsidies, combustion techniques, firing systems, optimal hydraulic solutions, cost and profitability comparison as well as the design, installation and maintenance of biomass boilers and stoves. The training should also provide good knowledge of any European standards for technology and biomass fuels, such as pellets, and biomass related national and Union law. (c) The theoretical part of the heat pump installer training should give an overview of the market situation for heat pumps and cover geothermal resources and ground source temperatures of different regions, soil and rock identification for thermal conductivity, regulations on using geothermal resources, feasibility of using heat pumps in buildings and determining the most suitable heat pump system, and knowledge about their technical requirements, safety, air filtering, connection with the heat source and system layout. The training should also provide good knowledge of any European standards for heat pumps, and of relevant national and Union law. The installer should demonstrate the following key competences: (i) a basic understanding of the physical and operation principles of a heat pump, including characteristics of the heat pump circle: context between low temperatures of the heat sink, high temperatures of the heat source, and the efficiency of the system, determination of the coefficient of performance and seasonal performance factor (SPF); (ii) an understanding of the components and their function within a heat pump circle, including the compressor, expansion valve, evaporator, condenser, fixtures and fittings, lubricating oil, refrigerant, superheating and sub-cooling and cooling possibilities with heat pumps; and (iii) the ability to choose and size the components in typical installation situations, including determining the typical values of the heat load of different buildings and for hot water production based on energy consumption, determining the capacity of the heat pump on the heat load for hot water production, on the storage mass of the building and on interruptible current supply; determine the buffer tank component and its volume and integration of a second heating system. (d) The theoretical part of the solar photovoltaic and solar thermal installer training should give an overview of the market situation of solar products and cost and profitability comparisons, and cover ecological aspects, components, characteristics and dimensioning of solar systems, selection of accurate systems and dimensioning of components, determination of the heat demand, fire protection, related subsidies, as well as the design, installation and maintenance of solar photovoltaic and solar thermal installations. The training should also provide good knowledge of any European standards for technology, and certification such as Solar Keymark, and related national and Union law. The installer should demonstrate the following key competences: (i) the ability to work safely using the required tools and equipment and implementing safety codes and standards and to identify plumbing, electrical and other hazards associated with solar installations; (ii) the ability to identify systems and their components specific to active and passive systems, including the mechanical design, and to determine the components' location and system layout and configuration; (iii) the ability to determine the required installation area, orientation and tilt for the solar photovoltaic and solar water heater, taking account of shading, solar access, structural integrity, the appropriateness of the installation for the building or the climate and to identify different installation methods suitable for roof types and the balance of system equipment required for the installation; and (iv) for solar photovoltaic systems in particular, the ability to adapt the electrical design, including determining design currents, selecting appropriate conductor types and ratings for each electrical circuit, determining appropriate size, ratings and locations for all associated equipment and subsystems and selecting an appropriate interconnection point. (e) The installer certification should be time restricted, so that a refresher seminar or event would be necessary for continued certification. ANNEX V RULES FOR CALCULATING THE GREENHOUSE GAS IMPACT OF BIOFUELS, BIOLIQUIDS AND THEIR FOSSIL FUEL COMPARATORS A. TYPICAL AND DEFAULT VALUES FOR BIOFUELS IF PRODUCED WITH NO NET CARBON EMISSIONS FROM LAND-USE CHANGE Biofuel production pathway Greenhouse gas emissions saving \u2013 typical value Greenhouse gas emissions saving \u2013 default value sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 67 % 59 % sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 77 % 73 % sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*)) 73 % 68 % sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*)) 79 % 76 % sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*)) 58 % 47 % sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*)) 71 % 64 % corn (maize) ethanol (natural gas as process fuel in conventional boiler) 48 % 40 % corn (maize) ethanol, (natural gas as process fuel in CHP plant (*)) 55 % 48 % corn (maize) ethanol (lignite as process fuel in CHP plant (*)) 40 % 28 % corn (maize) ethanol (forest residues as process fuel in CHP plant (*)) 69 % 68 % other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 47 % 38 % other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*)) 53 % 46 % other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*)) 37 % 24 % other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*)) 67 % 67 % sugar cane ethanol 70 % 70 % the part from renewable sources of ethyl-tertio-butyl-ether (ETBE) Equal to that of the ethanol production pathway used the part from renewable sources of tertiary-amyl-ethyl-ether (TAEE) Equal to that of the ethanol production pathway used rape seed biodiesel 52 % 47 % sunflower biodiesel 57 % 52 % soybean biodiesel 55 % 50 % palm oil biodiesel (open effluent pond) 32 % 19 % palm oil biodiesel (process with methane capture at oil mill) 51 % 45 % waste cooking oil biodiesel 88 % 84 % animal fats from rendering biodiesel (**) 84 % 78 % hydrotreated vegetable oil from rape seed 51 % 47 % hydrotreated vegetable oil from sunflower 58 % 54 % hydrotreated vegetable oil from soybean 55 % 51 % hydrotreated vegetable oil from palm oil (open effluent pond) 34 % 22 % hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 53 % 49 % hydrotreated oil from waste cooking oil 87 % 83 % hydrotreated oil from animal fats from rendering (**) 83 % 77 % pure vegetable oil from rape seed 59 % 57 % pure vegetable oil from sunflower 65 % 64 % pure vegetable oil from soybean 63 % 61 % pure vegetable oil from palm oil (open effluent pond) 40 % 30 % pure vegetable oil from palm oil (process with methane capture at oil mill) 59 % 57 % pure oil from waste cooking oil 98 % 98 % (*) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (**) Applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1), for which emissions related to hygenisation as part of the rendering are not considered. B. ESTIMATED TYPICAL AND DEFAULT VALUES FOR FUTURE BIOFUELS THAT WERE NOT ON THE MARKET OR WERE ON THE MARKET ONLY IN NEGLIGIBLE QUANTITIES IN 2016, IF PRODUCED WITH NO NET CARBON EMISSIONS FROM LAND-USE CHANGE Biofuel production pathway Greenhouse gas emissions saving - typical value Greenhouse gas emissions saving - default value wheat straw ethanol 85 % 83 % waste wood Fischer-Tropsch diesel in free-standing plant 85 % 85 % farmed wood Fischer-Tropsch diesel in free-standing plant 82 % 82 % waste wood Fischer-Tropsch petrol in free-standing plant 85 % 85 % farmed wood Fischer-Tropsch petrol in free-standing plant 82 % 82 % waste wood dimethylether (DME) in free-standing plant 86 % 86 % farmed wood dimethylether (DME) in free-standing plant 83 % 83 % waste wood methanol in free-standing plant 86 % 86 % farmed wood methanol in free-standing plant 83 % 83 % Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 89 % 89 % Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 89 % 89 % dimethylether (DME) from black-liquor gasification integrated with pulp mill 89 % 89 % Methanol from black-liquor gasification integrated with pulp mill 89 % 89 % the part from renewable sources of methyl-tertio-butyl-ether (MTBE) Equal to that of the methanol production pathway used C. METHODOLOGY 1. Greenhouse gas emissions from the production and use of transport fuels, biofuels and bioliquids shall be calculated as follows: (a) greenhouse gas emissions from the production and use of biofuels shall be calculated as: E = eec + el + ep + etd + eu \u2013 esca \u2013 eccs \u2013 eccr, where E = total emissions from the use of the fuel; eec = emissions from the extraction or cultivation of raw materials; el = annualised emissions from carbon stock changes caused by land-use change; ep = emissions from processing; etd = emissions from transport and distribution; eu = emissions from the fuel in use; esca = emission savings from soil carbon accumulation via improved agricultural management; eccs = emission savings from CO2 capture and geological storage; and eccr = emission savings from CO2 capture and replacement. Emissions from the manufacture of machinery and equipment shall not be taken into account. (b) Greenhouse gas emissions from the production and use of bioliquids shall be calculated as for biofuels (E), but with the extension necessary for including the energy conversion to electricity and/or heat and cooling produced, as follows: (i) For energy installations delivering only heat: (ii) For energy installations delivering only electricity: where ECh,el = Total greenhouse gas emissions from the final energy commodity. E = Total greenhouse gas emissions of the bioliquid before end-conversion. \u03b7el = The electrical efficiency, defined as the annual electricity produced divided by the annual bioliquid input based on its energy content. \u03b7h = The heat efficiency, defined as the annual useful heat output divided by the annual bioliquid input based on its energy content. (iii) For the electricity or mechanical energy coming from energy installations delivering useful heat together with electricity and/or mechanical energy: (iv) For the useful heat coming from energy installations delivering heat together with electricity and/or mechanical energy: where: ECh,el = Total greenhouse gas emissions from the final energy commodity. E = Total greenhouse gas emissions of the bioliquid before end-conversion. \u03b7el = The electrical efficiency, defined as the annual electricity produced divided by the annual fuel input based on its energy content. \u03b7h = The heat efficiency, defined as the annual useful heat output divided by the annual fuel input based on its energy content. Cel = Fraction of exergy in the electricity, and/or mechanical energy, set to 100 % (Cel = 1). Ch = Carnot efficiency (fraction of exergy in the useful heat). The Carnot efficiency, Ch, for useful heat at different temperatures is defined as: where Th = Temperature, measured in absolute temperature (kelvin) of the useful heat at point of delivery. T0 = Temperature of surroundings, set at 273,15 kelvin (equal to 0 \u00b0C) If the excess heat is exported for heating of buildings, at a temperature below 150 \u00b0C (423,15 kelvin), Ch can alternatively be defined as follows: Ch = Carnot efficiency in heat at 150 \u00b0C (423,15 kelvin), which is: 0,3546 For the purposes of that calculation, the following definitions apply: (a) \u2018cogeneration\u2019 means the simultaneous generation in one process of thermal energy and electricity and/or mechanical energy; (b) \u2018useful heat\u2019 means heat generated to satisfy an economical justifiable demand for heat, for heating and cooling purposes; (c) \u2018economically justifiable demand\u2019 means the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions. 2. Greenhouse gas emissions from biofuels and bioliquids shall be expressed as follows: (a) greenhouse gas emissions from biofuels, E, shall be expressed in terms of grams of CO2 equivalent per MJ of fuel, g CO2eq/MJ. (b) greenhouse gas emissions from bioliquids, EC, in terms of grams of CO2 equivalent per MJ of final energy commodity (heat or electricity), g CO2eq/MJ. When heating and cooling are co-generated with electricity, emissions shall be allocated between heat and electricity (as under 1(b)), irrespective if the heat is used for actual heating purposes or for cooling (2). Where the greenhouse gas emissions from the extraction or cultivation of raw materials eec are expressed in unit g CO2eq/dry-ton of feedstock, the conversion to grams of CO2 equivalent per MJ of fuel, g CO2eq/MJ, shall be calculated as follows (3): where Emissions per dry-ton feedstock shall be calculated as follows: 3. Greenhouse gas emissions savings from biofuels and bioliquids shall be calculated as follows: (a) greenhouse gas emissions savings from biofuels: SAVING = (EF(t) \u2013 EB)/EF(t), where EB = total emissions from the biofuel; and EF(t) = total emissions from the fossil fuel comparator for transport (b) greenhouse gas emissions savings from heat and cooling, and electricity being generated from bioliquids: SAVING = (ECF(h&c,el) \u2013 ECB(h&c,el))/ECF(h&c,el), where ECB(h&c,el) = total emissions from the heat or electricity; and ECF(h&c,el) = total emissions from the fossil fuel comparator for useful heat or electricity. 4. The greenhouse gases taken into account for the purposes of point 1 shall be CO2, N2O and CH4. For the purposes of calculating CO2 equivalence, those gases shall be valued as follows: CO2 : 1 N2O : 298 CH4 : 25 5. Emissions from the extraction or cultivation of raw materials, eec, shall include emissions from the extraction or cultivation process itself; from the collection, drying and storage of raw materials; from waste and leakages; and from the production of chemicals or products used in extraction or cultivation. Capture of CO2 in the cultivation of raw materials shall be excluded. Estimates of emissions from agriculture biomass cultivation may be derived from the use of regional averages for cultivation emissions included in the reports referred to in Article 31(4) or the information on the disaggregated default values for cultivation emissions included in this Annex, as an alternative to using actual values. In the absence of relevant information in those reports it is allowed to calculate averages based on local farming practises based for instance on data of a group of farms, as an alternative to using actual values. 6. For the purposes of the calculation referred to in point 1(a), greenhouse gas emissions savings from improved agriculture management, esca, such as shifting to reduced or zero-tillage, improved crop/rotation, the use of cover crops, including crop residue management, and the use of organic soil improver (e.g. compost, manure fermentation digestate), shall be taken into account only if solid and verifiable evidence is provided that the soil carbon has increased or that it is reasonable to expect to have increased over the period in which the raw materials concerned were cultivated while taking into account the emissions where such practices lead to increased fertiliser and herbicide use (4). 7. Annualised emissions from carbon stock changes caused by land-use change, el, shall be calculated by dividing total emissions equally over 20 years. For the calculation of those emissions, the following rule shall be applied: el = (CSR \u2013 CSA) \u00d7 3,664 \u00d7 1/20 \u00d7 1/P \u2013 eB, (5) where el = annualised greenhouse gas emissions from carbon stock change due to land-use change (measured as mass (grams) of CO2-equivalent per unit of biofuel or bioliquid energy (megajoules)). \u2018Cropland\u2019 (6) and \u2018perennial cropland\u2019 (7) shall be regarded as one land use; CSR = the carbon stock per unit area associated with the reference land-use (measured as mass (tonnes) of carbon per unit area, including both soil and vegetation). The reference land-use shall be the land-use in January 2008 or 20 years before the raw material was obtained, whichever was the later; CSA = the carbon stock per unit area associated with the actual land-use (measured as mass (tonnes) of carbon per unit area, including both soil and vegetation). In cases where the carbon stock accumulates over more than one year, the value attributed to CSA shall be the estimated stock per unit area after 20 years or when the crop reaches maturity, whichever the earlier; P = the productivity of the crop (measured as biofuel or bioliquid energy per unit area per year) and eB = bonus of 29 g CO2eq/MJ biofuel or bioliquid if biomass is obtained from restored degraded land under the conditions laid down in point 8. 8. The bonus of 29 g CO2eq/MJ shall be attributed if evidence is provided that the land: (a) was not in use for agriculture or any other activity in January 2008; and (b) is severely degraded land, including such land that was formerly in agricultural use. The bonus of 29 g CO2eq/MJ shall apply for a period of up to 20 years from the date of conversion of the land to agricultural use, provided that a steady increase in carbon stocks as well as a sizable reduction in erosion phenomena for land falling under (b) are ensured. 9. \u2018Severely degraded land\u2019 means land that, for a significant period of time, has either been significantly salinated or presented significantly low organic matter content and has been severely eroded. 10. The Commission shall review, by 31 December 2020, guidelines for the calculation of land carbon stocks (8) drawing on the 2006 IPCC Guidelines for National Greenhouse Gas Inventories \u2013 volume 4 and in accordance with Regulation (EU) No 525/2013 and Regulation (EU) 2018/841 of the European Parliament and of the Council (9). The Commission guidelines shall serve as the basis for the calculation of land carbon stocks for the purposes of this Directive. 11. Emissions from processing, ep, shall include emissions from the processing itself; from waste and leakages; and from the production of chemicals or products used in processing including the CO2 emissions corresponding to the carbon contents of fossil inputs, whether or not actually combusted in the process. In accounting for the consumption of electricity not produced within the fuel production plant, the greenhouse gas emissions intensity of the production and distribution of that electricity shall be assumed to be equal to the average emission intensity of the production and distribution of electricity in a defined region. By way of derogation from this rule, producers may use an average value for an individual electricity production plant for electricity produced by that plant, if that plant is not connected to the electricity grid. Emissions from processing shall include emissions from drying of interim products and materials where relevant. 12. Emissions from transport and distribution, etd, shall include emissions from the transport of raw and semi-finished materials and from the storage and distribution of finished materials. Emissions from transport and distribution to be taken into account under point 5 shall not be covered by this point. 13. Emissions of the fuel in use, eu, shall be taken to be zero for biofuels and bioliquids. Emissions of non-CO2 greenhouse gases (N2O and CH4) of the fuel in use shall be included in the eu factor for bioliquids. 14. Emission savings from CO2 capture and geological storage, eccs, that have not already been accounted for in ep, shall be limited to emissions avoided through the capture and storage of emitted CO2 directly related to the extraction, transport, processing and distribution of fuel if stored in compliance with Directive 2009/31/EC of the European Parliament and of the Council (10). 15. Emission savings from CO2 capture and replacement, eccr, shall be related directly to the production of biofuel or bioliquid they are attributed to, and shall be limited to emissions avoided through the capture of CO2 of which the carbon originates from biomass and which is used to replace fossil-derived CO2 in production of commercial products and services. 16. Where a cogeneration unit \u2013 providing heat and/or electricity to a fuel production process for which emissions are being calculated \u2013 produces excess electricity and/or excess useful heat, the greenhouse gas emissions shall be divided between the electricity and the useful heat according to the temperature of the heat (which reflects the usefulness (utility) of the heat). The useful part of the heat is found by multiplying its energy content with the Carnot efficiency, Ch, calculated as follows: where Th = Temperature, measured in absolute temperature (kelvin) of the useful heat at point of delivery. T0 = Temperature of surroundings, set at 273,15 kelvin (equal to 0 \u00b0C) If the excess heat is exported for heating of buildings, at a temperature below 150 \u00b0C (423,15 kelvin), Ch can alternatively be defined as follows: Ch = Carnot efficiency in heat at 150 \u00b0C (423,15 kelvin), which is: 0,3546 For the purposes of that calculation, the actual efficiencies shall be used, defined as the annual mechanical energy, electricity and heat produced respectively divided by the annual energy input. For the purposes of that calculation, the following definitions apply: (a) \u2018cogeneration\u2019 shall mean the simultaneous generation in one process of thermal energy and electrical and/or mechanical energy; (b) \u2018useful heat\u2019 shall mean heat generated to satisfy an economical justifiable demand for heat, for heating or cooling purposes; (c) \u2018economically justifiable demand\u2019 shall mean the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions. 17. Where a fuel production process produces, in combination, the fuel for which emissions are being calculated and one or more other products (co-products), greenhouse gas emissions shall be divided between the fuel or its intermediate product and the co-products in proportion to their energy content (determined by lower heating value in the case of co-products other than electricity and heat). The greenhouse gas intensity of excess useful heat or excess electricity is the same as the greenhouse gas intensity of heat or electricity delivered to the fuel production process and is determined from calculating the greenhouse intensity of all inputs and emissions, including the feedstock and CH4 and N2O emissions, to and from the cogeneration unit, boiler or other apparatus delivering heat or electricity to the fuel production process. In the case of cogeneration of electricity and heat, the calculation is performed following point 16. 18. For the purposes of the calculation referred to in point 17, the emissions to be divided shall be eec + el + esca + those fractions of ep, etd, eccs, and eccr that take place up to and including the process step at which a co-product is produced. If any allocation to co-products has taken place at an earlier process step in the life-cycle, the fraction of those emissions assigned in the last such process step to the intermediate fuel product shall be used for those purposes instead of the total of those emissions. In the case of biofuels and bioliquids, all co-products shall be taken into account for the purposes of that calculation. No emissions shall be allocated to wastes and residues. Co-products that have a negative energy content shall be considered to have an energy content of zero for the purposes of the calculation. Wastes and residues, including tree tops and branches, straw, husks, cobs and nut shells, and residues from processing, including crude glycerine (glycerine that is not refined) and bagasse, shall be considered to have zero life-cycle greenhouse gas emissions up to the process of collection of those materials irrespectively of whether they are processed to interim products before being transformed into the final product. In the case of fuels produced in refineries, other than the combination of processing plants with boilers or cogeneration units providing heat and/or electricity to the processing plant, the unit of analysis for the purposes of the calculation referred to in point 17 shall be the refinery. 19. For biofuels, for the purposes of the calculation referred to in point 3, the fossil fuel comparator EF(t) shall be 94 g CO2eq/MJ. For bioliquids used for the production of electricity, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(e) shall be 183 g CO2eq/MJ. For bioliquids used for the production of useful heat, as well as for the production of heating and/or cooling, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(h&c) shall be 80 g CO2eq/MJ. D. DISAGGREGATED DEFAULT VALUES FOR BIOFUELS AND BIOLIQUIDS Disaggregated default values for cultivation: \u2018eec\u2019 as defined in Part C of this Annex, including soil N2O emissions Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) sugar beet ethanol 9,6 9,6 corn (maize) ethanol 25,5 25,5 other cereals excluding corn (maize) ethanol 27,0 27,0 sugar cane ethanol 17,1 17,1 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 32,0 32,0 sunflower biodiesel 26,1 26,1 soybean biodiesel 21,2 21,2 palm oil biodiesel 26,2 26,2 waste cooking oil biodiesel 0 0 animal fats from rendering biodiesel (**) 0 0 hydrotreated vegetable oil from rape seed 33,4 33,4 hydrotreated vegetable oil from sunflower 26,9 26,9 hydrotreated vegetable oil from soybean 22,1 22,1 hydrotreated vegetable oil from palm oil 27,4 27,4 hydrotreated oil from waste cooking oil 0 0 hydrotreated oil from animal fats from rendering (**) 0 0 pure vegetable oil from rape seed 33,4 33,4 pure vegetable oil from sunflower 27,2 27,2 pure vegetable oil from soybean 22,2 22,2 pure vegetable oil from palm oil 27,1 27,1 pure oil from waste cooking oil 0 0 Disaggregated default values for cultivation: \u2018eec\u2019 \u2013 for soil N2O emissions only (these are already included in the disaggregated values for cultivation emissions in the \u2018eec\u2019 table) Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) sugar beet ethanol 4,9 4,9 corn (maize) ethanol 13,7 13,7 other cereals excluding corn (maize) ethanol 14,1 14,1 sugar cane ethanol 2,1 2,1 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 17,6 17,6 sunflower biodiesel 12,2 12,2 soybean biodiesel 13,4 13,4 palm oil biodiesel 16,5 16,5 waste cooking oil biodiesel 0 0 animal fats from rendering biodiesel (**) 0 0 hydrotreated vegetable oil from rape seed 18,0 18,0 hydrotreated vegetable oil from sunflower 12,5 12,5 hydrotreated vegetable oil from soybean 13,7 13,7 hydrotreated vegetable oil from palm oil 16,9 16,9 hydrotreated oil from waste cooking oil 0 0 hydrotreated oil from animal fats from rendering (**) 0 0 pure vegetable oil from rape seed 17,6 17,6 pure vegetable oil from sunflower 12,2 12,2 pure vegetable oil from soybean 13,4 13,4 pure vegetable oil from palm oil 16,5 16,5 pure oil from waste cooking oil 0 0 Disaggregated default values for processing: \u2018ep\u2019 as defined in Part C of this Annex Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 18,8 26,3 sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 9,7 13,6 sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*1)) 13,2 18,5 sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*1)) 7,6 10,6 sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*1)) 27,4 38,3 sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*1)) 15,7 22,0 corn (maize) ethanol (natural gas as process fuel in conventional boiler) 20,8 29,1 corn (maize) ethanol, (natural gas as process fuel in CHP plant (*1)) 14,8 20,8 corn (maize) ethanol (lignite as process fuel in CHP plant (*1)) 28,6 40,1 corn (maize) ethanol (forest residues as process fuel in CHP plant (*1)) 1,8 2,6 other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 21,0 29,3 other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*1)) 15,1 21,1 other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*1)) 30,3 42,5 other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*1)) 1,5 2,2 sugar cane ethanol 1,3 1,8 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 11,7 16,3 sunflower biodiesel 11,8 16,5 soybean biodiesel 12,1 16,9 palm oil biodiesel (open effluent pond) 30,4 42,6 palm oil biodiesel (process with methane capture at oil mill) 13,2 18,5 waste cooking oil biodiesel 9,3 13,0 animal fats from rendering biodiesel (*2) 13,6 19,1 hydrotreated vegetable oil from rape seed 10,7 15,0 hydrotreated vegetable oil from sunflower 10,5 14,7 hydrotreated vegetable oil from soybean 10,9 15,2 hydrotreated vegetable oil from palm oil (open effluent pond) 27,8 38,9 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 9,7 13,6 hydrotreated oil from waste cooking oil 10,2 14,3 hydrotreated oil from animal fats from rendering (*2) 14,5 20,3 pure vegetable oil from rape seed 3,7 5.2 pure vegetable oil from sunflower 3,8 5,4 pure vegetable oil from soybean 4,2 5,9 pure vegetable oil from palm oil (open effluent pond) 22,6 31,7 pure vegetable oil from palm oil (process with methane capture at oil mill) 4,7 6,5 pure oil from waste cooking oil 0,6 0,8 Disaggregated default values for oil extraction only (these are already included in the disaggregated values for processing emissions in the \u2018ep\u2019 table) Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) rape seed biodiesel 3,0 4,2 sunflower biodiesel 2,9 4,0 soybean biodiesel 3,2 4,4 palm oil biodiesel (open effluent pond) 20,9 29,2 palm oil biodiesel (process with methane capture at oil mill) 3,7 5,1 waste cooking oil biodiesel 0 0 animal fats from rendering biodiesel (**) 4,3 6,1 hydrotreated vegetable oil from rape seed 3,1 4,4 hydrotreated vegetable oil from sunflower 3,0 4,1 hydrotreated vegetable oil from soybean 3,3 4,6 hydrotreated vegetable oil from palm oil (open effluent pond) 21,9 30,7 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 3,8 5,4 hydrotreated oil from waste cooking oil 0 0 hydrotreated oil from animal fats from rendering (**) 4,3 6,0 pure vegetable oil from rape seed 3,1 4,4 pure vegetable oil from sunflower 3,0 4,2 pure vegetable oil from soybean 3,4 4,7 pure vegetable oil from palm oil (open effluent pond) 21,8 30,5 pure vegetable oil from palm oil (process with methane capture at oil mill) 3,8 5,3 pure oil from waste cooking oil 0 0 Disaggregated default values for transport and distribution: \u2018etd\u2019 as defined in Part C of this Annex Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 2,3 2,3 sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 2,3 2,3 sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*3)) 2,3 2,3 sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*3)) 2,3 2,3 sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*3)) 2,3 2,3 sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*3)) 2,3 2,3 corn (maize) ethanol (natural gas as process fuel in CHP plant (*3)) 2,2 2,2 corn (maize) ethanol (natural gas as process fuel in conventional boiler) 2,2 2,2 corn (maize) ethanol (lignite as process fuel in CHP plant (*3)) 2,2 2,2 corn (maize) ethanol (forest residues as process fuel in CHP plant (*3)) 2,2 2,2 other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 2,2 2,2 other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*3)) 2,2 2,2 other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*3)) 2,2 2,2 other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*3)) 2,2 2,2 sugar cane ethanol 9,7 9,7 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 1,8 1,8 sunflower biodiesel 2,1 2,1 soybean biodiesel 8,9 8,9 palm oil biodiesel (open effluent pond) 6,9 6,9 palm oil biodiesel (process with methane capture at oil mill) 6,9 6,9 waste cooking oil biodiesel 1,9 1,9 animal fats from rendering biodiesel (*4) 1,7 1,7 hydrotreated vegetable oil from rape seed 1,7 1,7 hydrotreated vegetable oil from sunflower 2,0 2,0 hydrotreated vegetable oil from soybean 9,2 9,2 hydrotreated vegetable oil from palm oil (open effluent pond) 7,0 7,0 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 7,0 7,0 hydrotreated oil from waste cooking oil 1,7 1,7 hydrotreated oil from animal fats from rendering (*4) 1,5 1,5 pure vegetable oil from rape seed 1,4 1,4 pure vegetable oil from sunflower 1,7 1,7 pure vegetable oil from soybean 8,8 8,8 pure vegetable oil from palm oil (open effluent pond) 6,7 6,7 pure vegetable oil from palm oil (process with methane capture at oil mill) 6,7 6,7 pure oil from waste cooking oil 1,4 1,4 Disaggregated default values for transport and distribution of final fuel only. These are already included in the table of \u2018transport and distribution emissions etd\u2019 as defined in Part C of this Annex, but the following values are useful if an economic operator wishes to declare actual transport emissions for crops or oil transport only). Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 1,6 1,6 sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 1,6 1,6 sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*5)) 1,6 1,6 sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*5)) 1,6 1,6 sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*5)) 1,6 1,6 sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*5)) 1,6 1,6 corn (maize) ethanol (natural gas as process fuel in conventional boiler) 1,6 1,6 corn (maize) ethanol (natural gas as process fuel in CHP plant (*5)) 1,6 1,6 corn (maize) ethanol (lignite as process fuel in CHP plant (*5)) 1,6 1,6 corn (maize) ethanol (forest residues as process fuel in CHP plant (*5)) 1,6 1,6 other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 1,6 1,6 other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*5)) 1,6 1,6 other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*5)) 1,6 1,6 other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*5)) 1,6 1,6 sugar cane ethanol 6,0 6,0 the part of ethyl-tertio-butyl-ether (ETBE) from renewable ethanol Will be considered to be equal to that of the ethanol production pathway used the part of tertiary-amyl-ethyl-ether (TAEE) from renewable ethanol Will be considered to be equal to that of the ethanol production pathway used rape seed biodiesel 1,3 1,3 sunflower biodiesel 1,3 1,3 soybean biodiesel 1,3 1,3 palm oil biodiesel (open effluent pond) 1,3 1,3 palm oil biodiesel (process with methane capture at oil mill) 1,3 1,3 waste cooking oil biodiesel 1,3 1,3 animal fats from rendering biodiesel (*6) 1,3 1,3 hydrotreated vegetable oil from rape seed 1,2 1,2 hydrotreated vegetable oil from sunflower 1,2 1,2 hydrotreated vegetable oil from soybean 1,2 1,2 hydrotreated vegetable oil from palm oil (open effluent pond) 1,2 1,2 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 1,2 1,2 hydrotreated oil from waste cooking oil 1,2 1,2 hydrotreated oil from animal fats from rendering (*6) 1,2 1,2 pure vegetable oil from rape seed 0,8 0,8 pure vegetable oil from sunflower 0,8 0,8 pure vegetable oil from soybean 0,8 0,8 pure vegetable oil from palm oil (open effluent pond) 0,8 0,8 pure vegetable oil from palm oil (process with methane capture at oil mill) 0,8 0,8 pure oil from waste cooking oil 0,8 0,8 Total for cultivation, processing, transport and distribution Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 30,7 38,2 sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 21,6 25,5 sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*7)) 25,1 30,4 sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*7)) 19,5 22,5 sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*7)) 39,3 50,2 sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*7)) 27,6 33,9 corn (maize) ethanol (natural gas as process fuel in conventional boiler) 48,5 56,8 corn (maize) ethanol, (natural gas as process fuel in CHP plant (*7)) 42,5 48,5 corn (maize) ethanol (lignite as process fuel in CHP plant (*7)) 56,3 67,8 corn (maize) ethanol (forest residues as process fuel in CHP plant (*7)) 29,5 30,3 other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 50,2 58,5 other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*7)) 44,3 50,3 other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*7)) 59,5 71,7 other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*7)) 30,7 31.4 sugar cane ethanol 28,1 28.6 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 45,5 50,1 sunflower biodiesel 40,0 44,7 soybean biodiesel 42,2 47,0 palm oil biodiesel (open effluent pond) 63,5 75,7 palm oil biodiesel (process with methane capture at oil mill) 46,3 51,6 waste cooking oil biodiesel 11,2 14,9 animals fats from rendering biodiesel (*8) 15,3 20,8 hydrotreated vegetable oil from rape seed 45,8 50,1 hydrotreated vegetable oil from sunflower 39,4 43,6 hydrotreated vegetable oil from soybean 42,2 46,5 hydrotreated vegetable oil from palm oil (open effluent pond) 62,2 73,3 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 44,1 48,0 hydrotreated oil from waste cooking oil 11,9 16,0 hydrotreated oil from animal fats from rendering (*8) 16,0 21,8 pure vegetable oil from rape seed 38,5 40,0 pure vegetable oil from sunflower 32,7 34,3 pure vegetable oil from soybean 35,2 36,9 pure vegetable oil from palm oil (open effluent pond) 56,3 65,4 pure vegetable oil from palm oil (process with methane capture at oil mill) 38,4 57,2 pure oil from waste cooking oil 2,0 2,2 E. ESTIMATED DISAGGREGATED DEFAULT VALUES FOR FUTURE BIOFUELS AND BIOLIQUIDS THAT WERE NOT ON THE MARKET OR WERE ONLY ON THE MARKET IN NEGLIGIBLE QUANTITIES IN 2016 Disaggregated default values for cultivation: \u2018eec\u2019 as defined in Part C of this Annex, including N2O emissions (including chipping of waste or farmed wood) Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) wheat straw ethanol 1,8 1,8 waste wood Fischer-Tropsch diesel in free-standing plant 3,3 3,3 farmed wood Fischer-Tropsch diesel in free-standing plant 8,2 8,2 waste wood Fischer-Tropsch petrol in free-standing plant 8,2 8,2 farmed wood Fischer-Tropsch petrol in free-standing plant 12,4 12,4 waste wood dimethylether (DME) in free-standing plant 3,1 3,1 farmed wood dimethylether (DME) in free-standing plant 7,6 7,6 waste wood methanol in free-standing plant 3,1 3,1 farmed wood methanol in free-standing plant 7,6 7,6 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 2,5 2,5 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 2,5 2,5 dimethylether (DME) from black-liquor gasification integrated with pulp mill 2,5 2,5 Methanol from black-liquor gasification integrated with pulp mill 2,5 2,5 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Disaggregated default values for soil N2O emissions (included in disaggregated default values for cultivation emissions in the \u2018eec\u2019 table) Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) wheat straw ethanol 0 0 waste wood Fischer-Tropsch diesel in free-standing plant 0 0 farmed wood Fischer-Tropsch diesel in free-standing plant 4,4 4,4 waste wood Fischer-Tropsch petrol in free-standing plant 0 0 farmed wood Fischer-Tropsch petrol in free-standing plant 4,4 4,4 waste wood dimethylether (DME) in free-standing plant 0 0 farmed wood dimethylether (DME) in free-standing plant 4,1 4,1 waste wood methanol in free-standing plant 0 0 farmed wood methanol in free-standing plant 4,1 4,1 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 0 0 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 0 0 dimethylether (DME) from black-liquor gasification integrated with pulp mill 0 0 Methanol from black-liquor gasification integrated with pulp mill 0 0 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Disaggregated default values for processing: \u2018ep\u2019 as defined in Part C of this Annex Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) wheat straw ethanol 4,8 6,8 waste wood Fischer-Tropsch diesel in free-standing plant 0,1 0,1 farmed wood Fischer-Tropsch diesel in free-standing plant 0,1 0,1 waste wood Fischer-Tropsch petrol in free-standing plant 0,1 0,1 farmed wood Fischer-Tropsch petrol in free-standing plant 0,1 0,1 waste wood dimethylether (DME) in free-standing plant 0 0 farmed wood dimethylether (DME) in free-standing plant 0 0 waste wood methanol in free-standing plant 0 0 farmed wood methanol in free-standing plant 0 0 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 0 0 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 0 0 dimethylether (DME) from black-liquor gasification integrated with pulp mill 0 0 methanol from black-liquor gasification integrated with pulp mill 0 0 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Disaggregated default values for transport and distribution: \u2018etd\u2019 as defined in Part C of this Annex Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) wheat straw ethanol 7,1 7,1 waste wood Fischer-Tropsch diesel in free-standing plant 10,3 10,3 farmed wood Fischer-Tropsch diesel in free-standing plant 8,4 8,4 waste wood Fischer-Tropsch petrol in free-standing plant 10,3 10,3 farmed wood Fischer-Tropsch petrol in free-standing plant 8,4 8,4 waste wood dimethylether (DME) in free-standing plant 10,4 10,4 farmed wood dimethylether (DME) in free-standing plant 8,6 8,6 waste wood methanol in free-standing plant 10,4 10,4 farmed wood methanol in free-standing plant 8,6 8,6 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 7,7 7,7 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 7,9 7,9 dimethylether (DME) from black-liquor gasification integrated with pulp mill 7,7 7,7 methanol from black-liquor gasification integrated with pulp mill 7,9 7,9 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Disaggregated default values for transport and distribution of final fuel only. These are already included in the table of \u2018transport and distribution emissions etd\u2019 as defined in Part C of this Annex, but the following values are useful if an economic operator wishes to declare actual transport emissions for feedstock transport only). Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) wheat straw ethanol 1,6 1,6 waste wood Fischer-Tropsch diesel in free-standing plant 1,2 1,2 farmed wood Fischer-Tropsch diesel in free-standing plant 1,2 1,2 waste wood Fischer-Tropsch petrol in free-standing plant 1,2 1,2 farmed wood Fischer-Tropsch petrol in free-standing plant 1,2 1,2 waste wood dimethylether (DME) in free-standing plant 2,0 2,0 farmed wood dimethylether (DME) in free-standing plant 2,0 2,0 waste wood methanol in free-standing plant 2,0 2,0 farmed wood methanol in free-standing plant 2,0 2,0 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 2,0 2,0 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 2,0 2,0 dimethylether (DME) from black-liquor gasification integrated with pulp mill 2,0 2,0 methanol from black-liquor gasification integrated with pulp mill 2,0 2,0 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Total for cultivation, processing, transport and distribution Biofuel and bioliquid production pathway Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) wheat straw ethanol 13,7 15,7 waste wood Fischer-Tropsch diesel in free-standing plant 13,7 13,7 farmed wood Fischer-Tropsch diesel in free-standing plant 16,7 16,7 waste wood Fischer-Tropsch petrol in free-standing plant 13,7 13,7 farmed wood Fischer-Tropsch petrol in free-standing plant 16,7 16,7 waste wood dimethylether (DME) in free-standing plant 13,5 13,5 farmed wood dimethylether (DME) in free-standing plant 16,2 16,2 waste wood methanol in free-standing plant 13,5 13,5 farmed wood methanol in free-standing plant 16,2 16,2 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 10,2 10,2 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 10,4 10,4 dimethylether (DME) from black-liquor gasification integrated with pulp mill 10,2 10,2 methanol from black-liquor gasification integrated with pulp mill 10,4 10,4 the part from renewable sources of MTBE Equal to that of the methanol production pathway used (1) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1). (2) Heat or waste heat is used to generate cooling (chilled air or water) through absorption chillers . Therefore, it is appropriate to calculate only the emissions associated to the heat produced per MJ of heat, irrespectively if the end-use of the heat is actual heating or cooling via absorption chillers. (3) The formula for calculating greenhouse gas emissions from the extraction or cultivation of raw materials eec describes cases where feedstock is converted into biofuels in one step. For more complex supply chains, adjustments are needed for calculating greenhouse gas emissions from the extraction or cultivation of raw materials eec for intermediate products. (4) Measurements of soil carbon can constitute such evidence, e.g. by a first measurement in advance of the cultivation and subsequent ones at regular intervals several years apart. In such a case, before the second measurement is available, increase in soil carbon would be estimated on the basis of representative experiments or soil models. From the second measurement onwards, the measurements would constitute the basis for determining the existence of an increase in soil carbon and its magnitude. (5) The quotient obtained by dividing the molecular weight of CO2 (44,010 g/mol) by the molecular weight of carbon (12,011 g/mol) is equal to 3,664. (6) Cropland as defined by IPCC. (7) Perennial crops are defined as multi-annual crops, the stem of which is usually not annually harvested such as short rotation coppice and oil palm. (8) Commission Decision 2010/335/EU of 10 June 2010 on guidelines for the calculation of land carbon stocks for the purpose of Annex V to Directive 2009/28/EC (OJ L 151, 17.6.2010, p. 19). (9) Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1). (10) Directive 2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive 85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC, 2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (OJ L 140, 5.6.2009, p. 114). (**) Applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (**) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (*1) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (*2) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (**) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (*3) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (*4) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (*5) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (*6) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (*7) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (*8) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. ANNEX VI RULES FOR CALCULATING THE GREENHOUSE GAS IMPACT OF BIOMASS FUELS AND THEIR FOSSIL FUEL COMPARATORS A. Typical and default values of greenhouse gas emissions savings for biomass fuels if produced with no net-carbon emissions from land-use change WOODCHIPS Biomass fuel production system Transport distance Greenhouse gas emissions savings \u2013typical value Greenhouse gas emissions savings \u2013 default value Heat Electricity Heat Electricity Woodchips from forest residues 1 to 500 km 93 % 89 % 91 % 87 % 500 to 2 500 km 89 % 84 % 87 % 81 % 2 500 to 10 000 km 82 % 73 % 78 % 67 % Above 10 000 km 67 % 51 % 60 % 41 % Woodchips from short rotation coppice (Eucalyptus) 2 500 to 10 000 km 77 % 65 % 73 % 60 % Woodchips from short rotation coppice (Poplar \u2013 Fertilised) 1 to 500 km 89 % 83 % 87 % 81 % 500 to 2 500 km 85 % 78 % 84 % 76 % 2 500 to 10 000 km 78 % 67 % 74 % 62 % Above 10 000 km 63 % 45 % 57 % 35 % Woodchips from short rotation coppice (Poplar \u2013 No fertilisation) 1 to 500 km 91 % 87 % 90 % 85 % 500 to 2 500 km 88 % 82 % 86 % 79 % 2 500 to 10 000 km 80 % 70 % 77 % 65 % Above 10 000 km 65 % 48 % 59 % 39 % Woodchips from stemwood 1 to 500 km 93 % 89 % 92 % 88 % 500 to 2 500 km 90 % 85 % 88 % 82 % 2 500 to 10 000 km 82 % 73 % 79 % 68 % Above 10 000 km 67 % 51 % 61 % 42 % Woodchips from industry residues 1 to 500 km 94 % 92 % 93 % 90 % 500 to 2 500 km 91 % 87 % 90 % 85 % 2 500 to 10 000 km 83 % 75 % 80 % 71 % Above 10 000 km 69 % 54 % 63 % 44 % WOOD PELLETS (*1) Biomass fuel production system Transport distance Greenhouse gas emissions savings \u2013 typical value Greenhouse gas emissions savings \u2013 default value Heat Electricity Heat Electricity Wood briquettes or pellets from forest residues Case 1 1 to 500 km 58 % 37 % 49 % 24 % 500 to 2 500 km 58 % 37 % 49 % 25 % 2 500 to 10 000 km 55 % 34 % 47 % 21 % Above 10 000 km 50 % 26 % 40 % 11 % Case 2a 1 to 500 km 77 % 66 % 72 % 59 % 500 to 2 500 km 77 % 66 % 72 % 59 % 2 500 to 10 000 km 75 % 62 % 70 % 55 % Above 10 000 km 69 % 54 % 63 % 45 % Case 3a 1 to 500 km 92 % 88 % 90 % 85 % 500 to 2 500 km 92 % 88 % 90 % 86 % 2 500 to 10 000 km 90 % 85 % 88 % 81 % Above 10 000 km 84 % 76 % 81 % 72 % Wood briquettes or pellets from short rotation coppice (Eucalyptus) Case 1 2 500 to 10 000 km 52 % 28 % 43 % 15 % Case 2a 2 500 to 10 000 km 70 % 56 % 66 % 49 % Case 3a 2 500 to 10 000 km 85 % 78 % 83 % 75 % Wood briquettes or pellets from short rotation coppice (Poplar \u2013 Fertilised) Case 1 1 to 500 km 54 % 32 % 46 % 20 % 500 to 10 000 km 52 % 29 % 44 % 16 % Above 10 000 km 47 % 21 % 37 % 7 % Case 2a 1 to 500 km 73 % 60 % 69 % 54 % 500 to 10 000 km 71 % 57 % 67 % 50 % Above 10 000 km 66 % 49 % 60 % 41 % Case 3a 1 to 500 km 88 % 82 % 87 % 81 % 500 to 10 000 km 86 % 79 % 84 % 77 % Above 10 000 km 80 % 71 % 78 % 67 % Wood briquettes or pellets from short rotation coppice (Poplar \u2013 No fertilisation) Case 1 1 to 500 km 56 % 35 % 48 % 23 % 500 to 10 000 km 54 % 32 % 46 % 20 % Above 10 000 km 49 % 24 % 40 % 10 % Case 2a 1 to 500 km 76 % 64 % 72 % 58 % 500 to 10 000 km 74 % 61 % 69 % 54 % Above 10 000 km 68 % 53 % 63 % 45 % Case 3a 1 to 500 km 91 % 86 % 90 % 85 % 500 to 10 000 km 89 % 83 % 87 % 81 % Above 10 000 km 83 % 75 % 81 % 71 % Stemwood Case 1 1 to 500 km 57 % 37 % 49 % 24 % 500 to 2 500 km 58 % 37 % 49 % 25 % 2 500 to 10 000 km 55 % 34 % 47 % 21 % Above 10 000 km 50 % 26 % 40 % 11 % Case 2a 1 to 500 km 77 % 66 % 73 % 60 % 500 to 2 500 km 77 % 66 % 73 % 60 % 2 500 to 10 000 km 75 % 63 % 70 % 56 % Above 10 000 km 70 % 55 % 64 % 46 % Case 3a 1 to 500 km 92 % 88 % 91 % 86 % 500 to 2 500 km 92 % 88 % 91 % 87 % 2 500 to 10 000 km 90 % 85 % 88 % 83 % Above 10 000 km 84 % 77 % 82 % 73 % Wood briquettes or pellets from wood industry residues Case 1 1 to 500 km 75 % 62 % 69 % 55 % 500 to 2 500 km 75 % 62 % 70 % 55 % 2 500 to 10 000 km 72 % 59 % 67 % 51 % Above 10 000 km 67 % 51 % 61 % 42 % Case 2a 1 to 500 km 87 % 80 % 84 % 76 % 500 to 2 500 km 87 % 80 % 84 % 77 % 2 500 to 10 000 km 85 % 77 % 82 % 73 % Above 10 000 km 79 % 69 % 75 % 63 % Case 3a 1 to 500 km 95 % 93 % 94 % 91 % 500 to 2 500 km 95 % 93 % 94 % 92 % 2 500 to 10 000 km 93 % 90 % 92 % 88 % Above 10 000 km 88 % 82 % 85 % 78 % AGRICULTURE PATHWAYS Biomass fuel production system Transport distance Greenhouse gas emissions savings \u2013 typical value Greenhouse gas emissions savings \u2013 default value Heat Electricity Heat Electricity Agricultural Residues with density < 0,2 t/m3 (*2) 1 to 500 km 95 % 92 % 93 % 90 % 500 to 2 500 km 89 % 83 % 86 % 80 % 2 500 to 10 000 km 77 % 66 % 73 % 60 % Above 10 000 km 57 % 36 % 48 % 23 % Agricultural Residues with density > 0,2 t/m3 (*3) 1 to 500 km 95 % 92 % 93 % 90 % 500 to 2 500 km 93 % 89 % 92 % 87 % 2 500 to 10 000 km 88 % 82 % 85 % 78 % Above 10 000 km 78 % 68 % 74 % 61 % Straw pellets 1 to 500 km 88 % 82 % 85 % 78 % 500 to 10 000 km 86 % 79 % 83 % 74 % Above 10 000 km 80 % 70 % 76 % 64 % Bagasse briquettes 500 to 10 000 km 93 % 89 % 91 % 87 % Above 10 000 km 87 % 81 % 85 % 77 % Palm Kernel Meal Above 10 000 km 20 % -18 % 11 % -33 % Palm Kernel Meal (no CH4 emissions from oil mill) Above 10 000 km 46 % 20 % 42 % 14 % BIOGAS FOR ELECTRICITY (*4) Biogas production system Technological option Greenhouse gas emissions savings \u2013 typical value Greenhouse gas emissions savings \u2013 default value Wet manure (1) Case 1 Open digestate (2) 146 % 94 % Close digestate (3) 246 % 240 % Case 2 Open digestate 136 % 85 % Close digestate 227 % 219 % Case 3 Open digestate 142 % 86 % Close digestate 243 % 235 % Maize whole plant (4) Case 1 Open digestate 36 % 21 % Close digestate 59 % 53 % Case 2 Open digestate 34 % 18 % Close digestate 55 % 47 % Case 3 Open digestate 28 % 10 % Close digestate 52 % 43 % Biowaste Case 1 Open digestate 47 % 26 % Close digestate 84 % 78 % Case 2 Open digestate 43 % 21 % Close digestate 77 % 68 % Case 3 Open digestate 38 % 14 % Close digestate 76 % 66 % BIOGAS FOR ELECTRICITY \u2013 MIXTURES OF MANURE AND MAIZE Biogas production system Technological option Greenhouse gas emissions savings \u2013 typical value Greenhouse gas emissions savings \u2013 default value Manure \u2013 Maize 80 % - 20 % Case 1 Open digestate 72 % 45 % Close digestate 120 % 114 % Case 2 Open digestate 67 % 40 % Close digestate 111 % 103 % Case 3 Open digestate 65 % 35 % Close digestate 114 % 106 % Manure \u2013 Maize 70 % - 30 % Case 1 Open digestate 60 % 37 % Close digestate 100 % 94 % Case 2 Open digestate 57 % 32 % Close digestate 93 % 85 % Case 3 Open digestate 53 % 27 % Close digestate 94 % 85 % Manure \u2013 Maize 60 % - 40 % Case 1 Open digestate 53 % 32 % Close digestate 88 % 82 % Case 2 Open digestate 50 % 28 % Close digestate 82 % 73 % Case 3 Open digestate 46 % 22 % Close digestate 81 % 72 % BIOMETHANE FOR TRANSPORT (*5) Biomethane production system Technological options Greenhouse gas emissions savings \u2013 typical value Greenhouse gas emissions savings \u2013 default value Wet manure Open digestate, no off-gas combustion 117 % 72 % Open digestate, off-gas combustion 133 % 94 % Close digestate, no off-gas combustion 190 % 179 % Close digestate, off-gas combustion 206 % 202 % Maize whole plant Open digestate, no off-gas combustion 35 % 17 % Open digestate, off-gas combustion 51 % 39 % Close digestate, no off-gas combustion 52 % 41 % Close digestate, off-gas combustion 68 % 63 % Biowaste Open digestate, no off-gas combustion 43 % 20 % Open digestate, off-gas combustion 59 % 42 % Close digestate, no off-gas combustion 70 % 58 % Close digestate, off-gas combustion 86 % 80 % BIOMETHANE \u2013 MIXTURES OF MANURE AND MAIZE (*6) Biomethane production system Technological options Greenhouse gas emissions savings \u2013 typical value Greenhouse gas emissions savings \u2013 default value Manure \u2013 Maize 80 % - 20 % Open digestate, no off-gas combustion (5) 62 % 35 % Open digestate, off-gas combustion (6) 78 % 57 % Close digestate, no off-gas combustion 97 % 86 % Close digestate, off-gas combustion 113 % 108 % Manure \u2013 Maize 70 % - 30 % Open digestate, no off-gas combustion 53 % 29 % Open digestate, off-gas combustion 69 % 51 % Close digestate, no off-gas combustion 83 % 71 % Close digestate, off-gas combustion 99 % 94 % Manure \u2013 Maize 60 % - 40 % Open digestate, no off-gas combustion 48 % 25 % Open digestate, off-gas combustion 64 % 48 % Close digestate, no off-gas combustion 74 % 62 % Close digestate, off-gas combustion 90 % 84 % B. METHODOLOGY 1. Greenhouse gas emissions from the production and use of biomass fuels, shall be calculated as follows: (a) Greenhouse gas emissions from the production and use of biomass fuels before conversion into electricity, heating and cooling, shall be calculated as: E = eec + el + ep + etd + eu \u2013 esca \u2013 eccs \u2013 eccr, Where E = total emissions from the production of the fuel before energy conversion; eec = emissions from the extraction or cultivation of raw materials; el = annualised emissions from carbon stock changes caused by land-use change; ep = emissions from processing; etd = emissions from transport and distribution; eu = emissions from the fuel in use; esca = emission savings from soil carbon accumulation via improved agricultural management; eccs = emission savings from CO2 capture and geological storage; and eccr = emission savings from CO2 capture and replacement. Emissions from the manufacture of machinery and equipment shall not be taken into account. (b) In the case of co-digestion of different substrates in a biogas plant for the production of biogas or biomethane, the typical and default values of greenhouse gas emissions shall be calculated as: where E = greenhouse gas emissions per MJ biogas or biomethane produced from co-digestion of the defined mixture of substrates Sn = Share of feedstock n in energy content En = Emission in g CO2/MJ for pathway n as provided in Part D of this Annex (*) where Pn = energy yield [MJ] per kilogram of wet input of feedstock n (**) Wn = weighting factor of substrate n defined as: where: In = Annual input to digester of substrate n [tonne of fresh matter] AMn = Average annual moisture of substrate n [kg water/kg fresh matter] SMn = Standard moisture for substrate n (***). (*) For animal manure used as substrate, a bonus of 45 g CO2eq/MJ manure (\u2013 54 kg CO2eq/t fresh matter) is added for improved agricultural and manure management. (**) The following values of Pn shall be used for calculating typical and default values: P(Maize): 4,16 [MJbiogas/kg wet maize @ 65 % moisture] P(Manure): 0,50 [MJbiogas/kg wet manure @ 90 % moisture] P(Biowaste) 3,41 [MJbiogas/kg wet biowaste @ 76 % moisture] (***) The following values of the standard moisture for substrate SMn shall be used: SM(Maize): 0,65 [kg water/kg fresh matter] SM(Manure): 0,90 [kg water/kg fresh matter] SM(Biowaste): 0,76 [kg water/kg fresh matter] (c) In the case of co-digestion of n substrates in a biogas plant for the production of electricity or biomethane, actual greenhouse gas emissions of biogas and biomethane are calculated as follows: where E = total emissions from the production of the biogas or biomethane before energy conversion; Sn = Share of feedstock n, in fraction of input to the digester; eec,n = emissions from the extraction or cultivation of feedstock n; etd,feedstock,n = emissions from transport of feedstock n to the digester; el,n = annualised emissions from carbon stock changes caused by land-use change, for feedstock n; esca = emission savings from improved agricultural management of feedstock n (*); ep = emissions from processing; etd,product = emissions from transport and distribution of biogas and/or biomethane; eu = emissions from the fuel in use, that is greenhouse gases emitted during combustion; eccs = emission savings from CO2 capture and geological storage; and eccr = emission savings from CO2 capture and replacement. (*) For esca a bonus of 45 g CO2eq/MJ manure shall be attributed for improved agricultural and manure management in the case animal manure is used as a substrate for the production of biogas and biomethane. (d) Greenhouse gas emissions from the use of biomass fuels in producing electricity, heating and cooling, including the energy conversion to electricity and/or heat or cooling produced, shall be calculated as follows: (i) For energy installations delivering only heat: (ii) For energy installations delivering only electricity: where ECh,el = Total greenhouse gas emissions from the final energy commodity. E = Total greenhouse gas emissions of the fuel before end-conversion. \u03b7el = The electrical efficiency, defined as the annual electricity produced divided by the annual fuel input, based on its energy content. \u03b7h = The heat efficiency, defined as the annual useful heat output divided by the annual fuel input, based on its energy content. (iii) For the electricity or mechanical energy coming from energy installations delivering useful heat together with electricity and/or mechanical energy: (iv) For the useful heat coming from energy installations delivering heat together with electricity and/or mechanical energy: where: ECh,el = Total greenhouse gas emissions from the final energy commodity. E = Total greenhouse gas emissions of the fuel before end-conversion. \u03b7el = The electrical efficiency, defined as the annual electricity produced divided by the annual energy input, based on its energy content. \u03b7h = The heat efficiency, defined as the annual useful heat output divided by the annual energy input, based on its energy content. Cel = Fraction of exergy in the electricity, and/or mechanical energy, set to 100 % (Cel = 1). Ch = Carnot efficiency (fraction of exergy in the useful heat). The Carnot efficiency, Ch, for useful heat at different temperatures is defined as: where: Th = Temperature, measured in absolute temperature (kelvin) of the useful heat at point of delivery. T0 = Temperature of surroundings, set at 273,15 kelvin (equal to 0 \u00b0C). If the excess heat is exported for heating of buildings, at a temperature below 150 \u00b0C (423,15 kelvin), Ch can alternatively be defined as follows: Ch = Carnot efficiency in heat at 150 \u00b0C (423,15 kelvin), which is: 0,3546 For the purposes of that calculation, the following definitions apply: (i) \u2018cogeneration\u2019 shall mean the simultaneous generation in one process of thermal energy and electricity and/or mechanical energy; (ii) \u2018useful heat\u2019 shall mean heat generated to satisfy an economical justifiable demand for heat, for heating or cooling purposes; (iii) \u2018economically justifiable demand\u2019 shall mean the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions. 2. Greenhouse gas emissions from biomass fuels shall be expressed as follows: (a) greenhouse gas emissions from biomass fuels, E, shall be expressed in terms of grams of CO2 equivalent per MJ of biomass fuel, g CO2eq/MJ; (b) greenhouse gas emissions from heating or electricity, produced from biomass fuels, EC, shall be expressed in terms of grams of CO2 equivalent per MJ of final energy commodity (heat or electricity), g CO2eq/MJ. When heating and cooling are co-generated with electricity, emissions shall be allocated between heat and electricity (as under point 1(d)), irrespective if the heat is used for actual heating purposes or for cooling. (7) Where the greenhouse gas emissions from the extraction or cultivation of raw materials eec are expressed in unit g CO2eq/dry-ton of feedstock, the conversion to grams of CO2 equivalent per MJ of fuel, g CO2eq /MJ, shall be calculated as follows (8): Where Emissions per dry-ton feedstock shall be calculated as follows: 3. Greenhouse gas emissions savings from biomass fuels shall be calculated as follows: (a) greenhouse gas emissions savings from biomass fuels used as transport fuels: SAVING = (EF(t) \u2013 EB)/EF(t) where EB = total emissions from biomass fuels used as transport fuels; and EF(t) = total emissions from the fossil fuel comparator for transport (b) greenhouse gas emissions savings from heat and cooling, and electricity being generated from biomass fuels: SAVING = (ECF(h&c,el) \u2013 ECB(h&c,el))/ECF (h&c,el), where ECB(h&c,el) = total emissions from the heat or electricity, ECF(h&c,el) = total emissions from the fossil fuel comparator for useful heat or electricity. 4. The greenhouse gases taken into account for the purposes of point 1 shall be CO2, N2O and CH4. For the purposes of calculating CO2 equivalence, those gases shall be valued as follows: CO2: 1 N2O: 298 CH4: 25 5. Emissions from the extraction, harvesting or cultivation of raw materials, eec, shall include emissions from the extraction, harvesting or cultivation process itself; from the collection, drying and storage of raw materials; from waste and leakages; and from the production of chemicals or products used in extraction or cultivation. Capture of CO2 in the cultivation of raw materials shall be excluded. Estimates of emissions from agriculture biomass cultivation may be derived from the regional averages for cultivation emissions included in the reports referred to in Article 31(4) of this Directive or the information on the disaggregated default values for cultivation emissions included in this Annex, as an alternative to using actual values. In the absence of relevant information in those reports it is allowed to calculate averages based on local farming practises based for instance on data of a group of farms, as an alternative to using actual values. Estimates of emissions from cultivation and harvesting of forestry biomass may be derived from the use of averages for cultivation and harvesting emissions calculated for geographical areas at national level, as an alternative to using actual values. 6. For the purposes of the calculation referred to in point 1(a), emission savings from improved agriculture management, esca, such as shifting to reduced or zero-tillage, improved crop/rotation, the use of cover crops, including crop residue management, and the use of organic soil improver (e.g. compost, manure fermentation digestate), shall be taken into account only if solid and verifiable evidence is provided that the soil carbon has increased or that it is reasonable to expect to have increased over the period in which the raw materials concerned were cultivated while taking into account the emissions where such practices lead to increased fertiliser and herbicide use (9). 7. Annualised emissions from carbon stock changes caused by land-use change, el, shall be calculated by dividing total emissions equally over 20 years. For the calculation of those emissions the following rule shall be applied: el = (CSR \u2013 CSA) \u00d7 3,664 \u00d7 1/20 \u00d7 1/P \u2013 eB, (10) where el = annualised greenhouse gas emissions from carbon stock change due to land-use change (measured as mass of CO2-equivalent per unit biomass fuel energy). \u2018Cropland\u2019 (11) and \u2018perennial cropland\u2019 (12) shall be regarded as one land use; CSR = the carbon stock per unit area associated with the reference land use (measured as mass (tonnes) of carbon per unit area, including both soil and vegetation). The reference land use shall be the land use in January 2008 or 20 years before the raw material was obtained, whichever was the later; CSA = the carbon stock per unit area associated with the actual land use (measured as mass (tonnes) of carbon per unit area, including both soil and vegetation). In cases where the carbon stock accumulates over more than one year, the value attributed to CSA shall be the estimated stock per unit area after 20 years or when the crop reaches maturity, whichever the earlier; P = the productivity of the crop (measured as biomass fuel energy per unit area per year); and eB = bonus of 29 g CO2eq/MJ biomass fuel if biomass is obtained from restored degraded land under the conditions laid down in point 8. 8. The bonus of 29 g CO2eq/MJ shall be attributed if evidence is provided that the land: (a) was not in use for agriculture in January 2008 or any other activity; and (b) is severely degraded land, including such land that was formerly in agricultural use. The bonus of 29 g CO2eq/MJ shall apply for a period of up to 20 years from the date of conversion of the land to agricultural use, provided that a steady increase in carbon stocks as well as a sizable reduction in erosion phenomena for land falling under (b) are ensured. 9. \u2018Severely degraded land\u2019 means land that, for a significant period of time, has either been significantly salinated or presented significantly low organic matter content and has been severely eroded. 10. In accordance with point 10 of Part C of Annex V to this Directive, Commission Decision 2010/335/EU (13), which provides for guidelines for the calculation of land carbon stocks in relation to this Directive, drawing on the 2006 IPCC Guidelines for National Greenhouse Gas Inventories \u2013 volume 4, and in accordance with Regulations (EU) No 525/2013 and (EU) 2018/841, shall serve as the basis for the calculation of land carbon stocks. 11. Emissions from processing, ep, shall include emissions from the processing itself; from waste and leakages; and from the production of chemicals or products used in processing, including the CO2 emissions corresponding to the carbon contents of fossil inputs, whether or not actually combusted in the process. In accounting for the consumption of electricity not produced within the solid or gaseous biomass fuel production plant, the greenhouse gas emissions intensity of the production and distribution of that electricity shall be assumed to be equal to the average emission intensity of the production and distribution of electricity in a defined region. By way of derogation from this rule, producers may use an average value for an individual electricity production plant for electricity produced by that plant, if that plant is not connected to the electricity grid. Emissions from processing shall include emissions from drying of interim products and materials where relevant. 12. Emissions from transport and distribution, etd, shall include emissions from the transport of raw and semi-finished materials and from the storage and distribution of finished materials. Emissions from transport and distribution to be taken into account under point 5 shall not be covered by this point. 13. Emissions of CO2 from fuel in use, eu, shall be taken to be zero for biomass fuels. Emissions of non-CO2 greenhouse gases (CH4 and N2O) from the fuel in use shall be included in the eu factor. 14. Emission savings from CO2 capture and geological storage, eccs, that have not already been accounted for in ep, shall be limited to emissions avoided through the capture and storage of emitted CO2 directly related to the extraction, transport, processing and distribution of biomass fuel if stored in compliance with Directive 2009/31/EC. 15. Emission savings from CO2 capture and replacement, eccr, shall be related directly to the production of biomass fuel they are attributed to, and shall be limited to emissions avoided through the capture of CO2 of which the carbon originates from biomass and which is used to replace fossil-derived CO2 in production of commercial products and services. 16. Where a cogeneration unit \u2013 providing heat and/or electricity to a biomass fuel production process for which emissions are being calculated \u2013 produces excess electricity and/or excess useful heat, the greenhouse gas emissions shall be divided between the electricity and the useful heat according to the temperature of the heat (which reflects the usefulness (utility) of the heat). The useful part of the heat is found by multiplying its energy content with the Carnot efficiency, Ch, calculated as follows: where Th = Temperature, measured in absolute temperature (kelvin) of the useful heat at point of delivery. T0 = Temperature of surroundings, set at 273,15 kelvin (equal to 0 \u00b0C). If the excess heat is exported for heating of buildings, at a temperature below 150 \u00b0C (423,15 kelvin), Ch can alternatively be defined as follows: Ch = Carnot efficiency in heat at 150 \u00b0C (423,15 kelvin), which is: 0,3546 For the purposes of that calculation, the actual efficiencies shall be used, defined as the annual mechanical energy, electricity and heat produced respectively divided by the annual energy input. For the purposes of that calculation, the following definitions apply: (a) \u2018cogeneration\u2019 shall mean the simultaneous generation in one process of thermal energy and electrical and/or mechanical energy; (b) \u2018useful heat\u2019 shall mean heat generated to satisfy an economical justifiable demand for heat, for heating or cooling purposes; (c) \u2018economically justifiable demand\u2019 shall mean the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions. 17. Where a biomass fuel production process produces, in combination, the fuel for which emissions are being calculated and one or more other products (\u2018co-products\u2019), greenhouse gas emissions shall be divided between the fuel or its intermediate product and the co-products in proportion to their energy content (determined by lower heating value in the case of co-products other than electricity and heat). The greenhouse gas intensity of excess useful heat or excess electricity is the same as the greenhouse gas intensity of heat or electricity delivered to the biomass fuel production process and is determined from calculating the greenhouse gas intensity of all inputs and emissions, including the feedstock and CH4 and N2O emissions, to and from the cogeneration unit, boiler or other apparatus delivering heat or electricity to the biomass fuel production process. In the case of cogeneration of electricity and heat, the calculation is performed following point 16. 18. For the purposes of the calculations referred to in point 17, the emissions to be divided shall be eec + el + esca + those fractions of ep, etd, eccs and eccr that take place up to and including the process step at which a co-product is produced. If any allocation to co-products has taken place at an earlier process step in the life-cycle, the fraction of those emissions assigned in the last such process step to the intermediate fuel product shall be used for those purposes instead of the total of those emissions. In the case of biogas and biomethane, all co-products that do not fall under the scope of point 7 shall be taken into account for the purposes of that calculation. No emissions shall be allocated to wastes and residues. Co-products that have a negative energy content shall be considered to have an energy content of zero for the purposes of the calculation. Wastes and residues, including tree tops and branches, straw, husks, cobs and nut shells, and residues from processing, including crude glycerine (glycerine that is not refined) and bagasse, shall be considered to have zero life-cycle greenhouse gas emissions up to the process of collection of those materials irrespectively of whether they are processed to interim products before being transformed into the final product. In the case of biomass fuels produced in refineries, other than the combination of processing plants with boilers or cogeneration units providing heat and/or electricity to the processing plant, the unit of analysis for the purposes of the calculation referred to in point 17 shall be the refinery. 19. For biomass fuels used for the production of electricity, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(el) shall be 183 g CO2eq/MJ electricity or 212 g CO2eq/MJ electricity for the outermost regions. For biomass fuels used for the production of useful heat, as well as for the production of heating and/or cooling, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(h) shall be 80 g CO2eq/MJ heat. For biomass fuels used for the production of useful heat, in which a direct physical substitution of coal can be demonstrated, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(h) shall be 124 g CO2eq/MJ heat. For biomass fuels used as transport fuels, for the purposes of the calculation referred to in point 3, the fossil fuel comparator EF(t) shall be 94 g CO2eq/MJ. C. DISAGGREGATED DEFAULT VALUES FOR BIOMASS FUELS Wood briquettes or pellets Biomass fuel production system Transport distance Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) Cultivation Processing Transport Non-CO2 emissions from the fuel in use Cultivation Processing Transport Non-CO2 emissions from the fuel in use Wood chips from forest residues 1 to 500 km 0,0 1,6 3,0 0,4 0,0 1,9 3,6 0,5 500 to 2 500 km 0,0 1,6 5,2 0,4 0,0 1,9 6,2 0,5 2 500 to 10 000 km 0,0 1,6 10,5 0,4 0,0 1,9 12,6 0,5 Above 10 000 km 0,0 1,6 20,5 0,4 0,0 1,9 24,6 0,5 Wood chips from SRC (Eucalyptus) 2 500 to 10 000 km 4,4 0,0 11,0 0,4 4,4 0,0 13,2 0,5 Wood chips from SRC (Poplar \u2013 fertilised) 1 to 500 km 3,9 0,0 3,5 0,4 3,9 0,0 4,2 0,5 500 to 2 500 km 3,9 0,0 5,6 0,4 3,9 0,0 6,8 0,5 2 500 to 10 000 km 3,9 0,0 11,0 0,4 3,9 0,0 13,2 0,5 Above 10 000 km 3,9 0,0 21,0 0,4 3,9 0,0 25,2 0,5 Wood chips from SRC (Poplar \u2013 Not fertilised) 1 to 500 km 2,2 0,0 3,5 0,4 2,2 0,0 4,2 0,5 500 to 2 500 km 2,2 0,0 5,6 0,4 2,2 0,0 6,8 0,5 2 500 to 10 000 km 2,2 0,0 11,0 0,4 2,2 0,0 13,2 0,5 Above 10 000 km 2,2 0,0 21,0 0,4 2,2 0,0 25,2 0,5 Wood chips from stemwood 1 to 500 km 1,1 0,3 3,0 0,4 1,1 0,4 3,6 0,5 500 to 2 500 km 1,1 0,3 5,2 0,4 1,1 0,4 6,2 0,5 2 500 to 10 000 km 1,1 0,3 10,5 0,4 1,1 0,4 12,6 0,5 Above 10 000 km 1,1 0,3 20,5 0,4 1,1 0,4 24,6 0,5 Wood chips from wood industry residues 1 to 500 km 0,0 0,3 3,0 0,4 0,0 0,4 3,6 0,5 500 to 2 500 km 0,0 0,3 5,2 0,4 0,0 0,4 6,2 0,5 2 500 to 10 000 km 0,0 0,3 10,5 0,4 0,0 0,4 12,6 0,5 Above 10 000 km 0,0 0,3 20,5 0,4 0,0 0,4 24,6 0,5 Wood briquettes or pellets Biomass fuel production system Transport distance Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) Cultivation Processing Transport & distribution Non-CO2 emissions from the fuel in use Cultivation Processing Transport & distribution Non-CO2 emissions from the fuel in use Wood briquettes or pellets from forest residues (case 1) 1 to 500 km 0,0 25,8 2,9 0,3 0,0 30,9 3,5 0,3 500 to 2 500 km 0,0 25,8 2,8 0,3 0,0 30,9 3,3 0,3 2 500 to 10 000 km 0,0 25,8 4,3 0,3 0,0 30,9 5,2 0,3 Above 10 000 km 0,0 25,8 7,9 0,3 0,0 30,9 9,5 0,3 Wood briquettes or pellets from forest residues (case 2a) 1 to 500 km 0,0 12,5 3,0 0,3 0,0 15,0 3,6 0,3 500 to 2 500 km 0,0 12,5 2,9 0,3 0,0 15,0 3,5 0,3 2 500 to 10 000 km 0,0 12,5 4,4 0,3 0,0 15,0 5,3 0,3 Above 10 000 km 0,0 12,5 8,1 0,3 0,0 15,0 9,8 0,3 Wood briquettes or pellets from forest residues (case 3a) 1 to 500 km 0,0 2,4 3,0 0,3 0,0 2,8 3,6 0,3 500 to 2 500 km 0,0 2,4 2,9 0,3 0,0 2,8 3,5 0,3 2 500 to 10 000 km 0,0 2,4 4,4 0,3 0,0 2,8 5,3 0,3 Above 10 000 km 0,0 2,4 8,2 0,3 0,0 2,8 9,8 0,3 Wood briquettes from short rotation coppice (Eucalyptus \u2013 case 1) 2 500 to 10 000 km 3,9 24,5 4,3 0,3 3,9 29,4 5,2 0,3 Wood briquettes from short rotation coppice (Eucalyptus \u2013 case 2a) 2 500 to 10 000 km 5,0 10,6 4,4 0,3 5,0 12,7 5,3 0,3 Wood briquettes from short rotation coppice (Eucalyptus \u2013 case 3a) 2 500 to 10 000 km 5,3 0,3 4,4 0,3 5,3 0,4 5,3 0,3 Wood briquettes from short rotation coppice (Poplar \u2013 Fertilised \u2013 case 1) 1 to 500 km 3,4 24,5 2,9 0,3 3,4 29,4 3,5 0,3 500 to 10 000 km 3,4 24,5 4,3 0,3 3,4 29,4 5,2 0,3 Above 10 000 km 3,4 24,5 7,9 0,3 3,4 29,4 9,5 0,3 Wood briquettes from short rotation coppice (Poplar \u2013 Fertilised \u2013 case 2a) 1 to 500 km 4,4 10,6 3,0 0,3 4,4 12,7 3,6 0,3 500 to 10 000 km 4,4 10,6 4,4 0,3 4,4 12,7 5,3 0,3 Above 10 000 km 4,4 10,6 8,1 0,3 4,4 12,7 9,8 0,3 Wood briquettes from short rotation coppice (Poplar \u2013 Fertilised \u2013 case 3a) 1 to 500 km 4,6 0,3 3,0 0,3 4,6 0,4 3,6 0,3 500 to 10 000 km 4,6 0,3 4,4 0,3 4,6 0,4 5,3 0,3 Above 10 000 km 4,6 0,3 8,2 0,3 4,6 0,4 9,8 0,3 Wood briquettes from short rotation coppice (Poplar \u2013 no fertilisation \u2013 case 1) 1 to 500 km 2,0 24,5 2,9 0,3 2,0 29,4 3,5 0,3 500 to 2 500 km 2,0 24,5 4,3 0,3 2,0 29,4 5,2 0,3 2 500 to 10 000 km 2,0 24,5 7,9 0,3 2,0 29,4 9,5 0,3 Wood briquettes from short rotation coppice (Poplar \u2013 no fertilisation \u2013 case 2a) 1 to 500 km 2,5 10,6 3,0 0,3 2,5 12,7 3,6 0,3 500 to 10 000 km 2,5 10,6 4,4 0,3 2,5 12,7 5,3 0,3 Above 10 000 km 2,5 10,6 8,1 0,3 2,5 12,7 9,8 0,3 Wood briquettes from short rotation coppice (Poplar \u2013 no fertilisation\u2013 case 3a) 1 to 500 km 2,6 0,3 3,0 0,3 2,6 0,4 3,6 0,3 500 to 10 000 km 2,6 0,3 4,4 0,3 2,6 0,4 5,3 0,3 Above 10 000 km 2,6 0,3 8,2 0,3 2,6 0,4 9,8 0,3 Wood briquettes or pellets from stemwood (case 1) 1 to 500 km 1,1 24,8 2,9 0,3 1,1 29,8 3,5 0,3 500 to 2 500 km 1,1 24,8 2,8 0,3 1,1 29,8 3,3 0,3 2 500 to 10 000 km 1,1 24,8 4,3 0,3 1,1 29,8 5,2 0,3 Above 10 000 km 1,1 24,8 7,9 0,3 1,1 29,8 9,5 0,3 Wood briquettes or pellets from stemwood (case 2a) 1 to 500 km 1,4 11,0 3,0 0,3 1,4 13,2 3,6 0,3 500 to 2 500 km 1,4 11,0 2,9 0,3 1,4 13,2 3,5 0,3 2 500 to 10 000 km 1,4 11,0 4,4 0,3 1,4 13,2 5,3 0,3 Above 10 000 km 1,4 11,0 8,1 0,3 1,4 13,2 9,8 0,3 Wood briquettes or pellets from stemwood (case 3a) 1 to 500 km 1,4 0,8 3,0 0,3 1,4 0,9 3,6 0,3 500 to 2 500 km 1,4 0,8 2,9 0,3 1,4 0,9 3,5 0,3 2 500 to 10 000 km 1,4 0,8 4,4 0,3 1,4 0,9 5,3 0,3 Above 10 000 km 1,4 0,8 8,2 0,3 1,4 0,9 9,8 0,3 Wood briquettes or pellets from wood industry residues (case 1) 1 to 500 km 0,0 14,3 2,8 0,3 0,0 17,2 3,3 0,3 500 to 2 500 km 0,0 14,3 2,7 0,3 0,0 17,2 3,2 0,3 2 500 to 10 000 km 0,0 14,3 4,2 0,3 0,0 17,2 5,0 0,3 Above 10 000 km 0,0 14,3 7,7 0,3 0,0 17,2 9,2 0,3 Wood briquettes or pellets from wood industry residues (case 2a) 1 to 500 km 0,0 6,0 2,8 0,3 0,0 7,2 3,4 0,3 500 to 2 500 km 0,0 6,0 2,7 0,3 0,0 7,2 3,3 0,3 2 500 to 10 000 km 0,0 6,0 4,2 0,3 0,0 7,2 5,1 0,3 Above 10 000 km 0,0 6,0 7,8 0,3 0,0 7,2 9,3 0,3 Wood briquettes or pellets from wood industry residues (case 3a) 1 to 500 km 0,0 0,2 2,8 0,3 0,0 0,3 3,4 0,3 500 to 2 500 km 0,0 0,2 2,7 0,3 0,0 0,3 3,3 0,3 2 500 to 10 000 km 0,0 0,2 4,2 0,3 0,0 0,3 5,1 0,3 Above 10 000 km 0,0 0,2 7,8 0,3 0,0 0,3 9,3 0,3 Agriculture pathways Biomass fuel production system Transport distance Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) Cultivation Processing Transport & distribution Non-CO2 emissions from the fuel in use Cultivation Processing Transport & distribution Non-CO2 emissions from the fuel in use Agricultural Residues with density < 0,2 t/m3 1 to 500 km 0,0 0,9 2,6 0,2 0,0 1,1 3,1 0,3 500 to 2 500 km 0,0 0,9 6,5 0,2 0,0 1,1 7,8 0,3 2 500 to 10 000 km 0,0 0,9 14,2 0,2 0,0 1,1 17,0 0,3 Above 10 000 km 0,0 0,9 28,3 0,2 0,0 1,1 34,0 0,3 Agricultural Residues with density > 0,2 t/m3 1 to 500 km 0,0 0,9 2,6 0,2 0,0 1,1 3,1 0,3 500 to 2 500 km 0,0 0,9 3,6 0,2 0,0 1,1 4,4 0,3 2 500 to 10 000 km 0,0 0,9 7,1 0,2 0,0 1,1 8,5 0,3 Above 10 000 km 0,0 0,9 13,6 0,2 0,0 1,1 16,3 0,3 Straw pellets 1 to 500 km 0,0 5,0 3,0 0,2 0,0 6,0 3,6 0,3 500 to 10 000 km 0,0 5,0 4,6 0,2 0,0 6,0 5,5 0,3 Above 10 000 km 0,0 5,0 8,3 0,2 0,0 6,0 10,0 0,3 Bagasse briquettes 500 to 10 000 km 0,0 0,3 4,3 0,4 0,0 0,4 5,2 0,5 Above 10 000 km 0,0 0,3 8,0 0,4 0,0 0,4 9,5 0,5 Palm Kernel Meal Above 10 000 km 21,6 21,1 11,2 0,2 21,6 25,4 13,5 0,3 Palm Kernel Meal (no CH4 emissions from oil mill) Above 10 000 km 21,6 3,5 11,2 0,2 21,6 4,2 13,5 0,3 Disaggregated default values for biogas for the production of electricity Biomass fuel production system Technology TYPICAL VALUE [g CO2eq/MJ] DEFAULT VALUE [g CO2eq/MJ] Cultivation Processing Non-CO2 emissions from the fuel in use Transport Manure credits Cultivation Processing Non-CO2 emissions from the fuel in use Transport Manure credits Wet manure (14) case 1 Open digestate 0,0 69,6 8,9 0,8 \u2013 107,3 0,0 97,4 12,5 0,8 \u2013 107,3 Close digestate 0,0 0,0 8,9 0,8 \u2013 97,6 0,0 0,0 12,5 0,8 \u2013 97,6 case 2 Open digestate 0,0 74,1 8,9 0,8 \u2013 107,3 0,0 103,7 12,5 0,8 \u2013 107,3 Close digestate 0,0 4,2 8,9 0,8 \u2013 97,6 0,0 5,9 12,5 0,8 \u2013 97,6 case 3 Open digestate 0,0 83,2 8,9 0,9 \u2013 120,7 0,0 116,4 12,5 0,9 \u2013 120,7 Close digestate 0,0 4,6 8,9 0,8 \u2013 108,5 0,0 6,4 12,5 0,8 \u2013 108,5 Maize whole plant (15) case 1 Open digestate 15,6 13,5 8,9 0,0 (16) \u2014 15,6 18,9 12,5 0,0 \u2014 Close digestate 15,2 0,0 8,9 0,0 \u2014 15,2 0,0 12,5 0,0 \u2014 case 2 Open digestate 15,6 18,8 8,9 0,0 \u2014 15,6 26,3 12,5 0,0 \u2014 Close digestate 15,2 5,2 8,9 0,0 \u2014 15,2 7,2 12,5 0,0 \u2014 case 3 Open digestate 17,5 21,0 8,9 0,0 \u2014 17,5 29,3 12,5 0,0 \u2014 Close digestate 17,1 5,7 8,9 0,0 \u2014 17,1 7,9 12,5 0,0 \u2014 Biowaste case 1 Open digestate 0,0 21,8 8,9 0,5 \u2014 0,0 30,6 12,5 0,5 \u2014 Close digestate 0,0 0,0 8,9 0,5 \u2014 0,0 0,0 12,5 0,5 \u2014 case 2 Open digestate 0,0 27,9 8,9 0,5 \u2014 0,0 39,0 12,5 0,5 \u2014 Close digestate 0,0 5,9 8,9 0,5 \u2014 0,0 8,3 12,5 0,5 \u2014 case 3 Open digestate 0,0 31,2 8,9 0,5 \u2014 0,0 43,7 12,5 0,5 \u2014 Close digestate 0,0 6,5 8,9 0,5 \u2014 0,0 9,1 12,5 0,5 \u2014 Disaggregated default values for biomethane Biomethane production system Technological option TYPICAL VALUE [g CO2eq/MJ] DEFAULT VALUE [g CO2eq/MJ] Cultivation Processing Upgrading Transport Compression at filling station Manure credits Cultivation Processing Upgrading Transport Compression at filling station Manure credits Wet manure Open digestate no off-gas combustion 0,0 84,2 19,5 1,0 3,3 \u2013 124,4 0,0 117,9 27,3 1,0 4,6 \u2013 124,4 off-gas combustion 0,0 84,2 4,5 1,0 3,3 \u2013 124,4 0,0 117,9 6,3 1,0 4,6 \u2013 124,4 Close digestate no off-gas combustion 0,0 3,2 19,5 0,9 3,3 \u2013 111,9 0,0 4,4 27,3 0,9 4,6 \u2013 111,9 off-gas combustion 0,0 3,2 4,5 0,9 3,3 \u2013 111,9 0,0 4,4 6,3 0,9 4,6 \u2013 111,9 Maize whole plant Open digestate no off-gas combustion 18,1 20,1 19,5 0,0 3,3 \u2014 18,1 28,1 27,3 0,0 4,6 \u2014 off-gas combustion 18,1 20,1 4,5 0,0 3,3 \u2014 18,1 28,1 6,3 0,0 4,6 \u2014 Close digestate no off-gas combustion 17,6 4,3 19,5 0,0 3,3 \u2014 17,6 6,0 27,3 0,0 4,6 \u2014 off-gas combustion 17,6 4,3 4,5 0,0 3,3 \u2014 17,6 6,0 6,3 0,0 4,6 \u2014 Biowaste Open digestate no off-gas combustion 0,0 30,6 19,5 0,6 3,3 \u2014 0,0 42,8 27,3 0,6 4,6 \u2014 off-gas combustion 0,0 30,6 4,5 0,6 3,3 \u2014 0,0 42,8 6,3 0,6 4,6 \u2014 Close digestate no off-gas combustion 0,0 5,1 19,5 0,5 3,3 \u2014 0,0 7,2 27,3 0,5 4,6 \u2014 off-gas combustion 0,0 5,1 4,5 0,5 3,3 \u2014 0,0 7,2 6,3 0,5 4,6 \u2014 D. TOTAL TYPICAL AND DEFAULT VALUES FOR BIOMASS FUEL PATHWAYS Biomass fuel production system Transport distance Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) Woodchips from forest residues 1 to 500 km 5 6 500 to 2 500 km 7 9 2 500 to 10 000 km 12 15 Above 10 000 km 22 27 Woodchips from short rotation coppice (Eucalyptus) 2 500 to 10 000 km 16 18 Woodchips from short rotation coppice (Poplar \u2013 Fertilised) 1 to 500 km 8 9 500 to 2 500 km 10 11 2 500 to 10 000 km 15 18 Above 10 000 km 25 30 Woodchips from short rotation coppice (Poplar \u2013 No fertilisation) 1 to 500 km 6 7 500 to 2 500 km 8 10 2 500 to 10 000 km 14 16 Above 10 000 km 24 28 Woodchips from stemwood 1 to 500 km 5 6 500 to 2 500 km 7 8 2 500 to 10 000 km 12 15 Above 10 000 km 22 27 Woodchips from industry residues 1 to 500 km 4 5 500 to 2 500 km 6 7 2 500 to 10 000 km 11 13 Above 10 000 km 21 25 Wood briquettes or pellets from forest residues (case 1) 1 to 500 km 29 35 500 to 2 500 km 29 35 2 500 to 10 000 km 30 36 Above 10 000 km 34 41 Wood briquettes or pellets from forest residues (case 2a) 1 to 500 km 16 19 500 to 2 500 km 16 19 2 500 to 10 000 km 17 21 Above 10 000 km 21 25 Wood briquettes or pellets from forest residues (case 3a) 1 to 500 km 6 7 500 to 2 500 km 6 7 2 500 to 10 000 km 7 8 Above 10 000 km 11 13 Wood briquettes or pellets from short rotation coppice (Eucalyptus \u2013 case 1) 2 500 to 10 000 km 33 39 Wood briquettes or pellets from short rotation coppice (Eucalyptus \u2013 case 2a) 2 500 to 10 000 km 20 23 Wood briquettes or pellets from short rotation coppice (Eucalyptus \u2013 case 3a) 2 500 to 10 000 km 10 11 Wood briquettes or pellets from short rotation coppice (Poplar \u2013 Fertilised \u2013 case 1) 1 to 500 km 31 37 500 to 10 000 km 32 38 Above 10 000 km 36 43 Wood briquettes or pellets from short rotation coppice (Poplar \u2013 Fertilised \u2013 case 2a) 1 to 500 km 18 21 500 to 10 000 km 20 23 Above 10 000 km 23 27 Wood briquettes or pellets from short rotation coppice (Poplar \u2013 Fertilised \u2013 case 3a) 1 to 500 km 8 9 500 to 10 000 km 10 11 Above 10 000 km 13 15 Wood briquettes or pellets from short rotation coppice (Poplar \u2013 no fertilisation \u2013 case 1) 1 to 500 km 30 35 500 to 10 000 km 31 37 Above 10 000 km 35 41 Wood briquettes or pellets from short rotation coppice (Poplar \u2013 no fertilisation \u2013 case 2a) 1 to 500 km 16 19 500 to 10 000 km 18 21 Above 10 000 km 21 25 Wood briquettes or pellets from short rotation coppice (Poplar \u2013 no fertilisation \u2013 case 3a) 1 to 500 km 6 7 500 to 10 000 km 8 9 Above 10 000 km 11 13 Wood briquettes or pellets from stemwood (case 1) 1 to 500 km 29 35 500 to 2 500 km 29 34 2 500 to 10 000 km 30 36 Above 10 000 km 34 41 Wood briquettes or pellets from stemwood (case 2a) 1 to 500 km 16 18 500 to 2 500 km 15 18 2 500 to 10 000 km 17 20 Above 10 000 km 21 25 Wood briquettes or pellets from stemwood (case 3a) 1 to 500 km 5 6 500 to 2 500 km 5 6 2 500 to 10 000 km 7 8 Above 10 000 km 11 12 Wood briquettes or pellets from wood industry residues (case 1) 1 to 500 km 17 21 500 to 2 500 km 17 21 2 500 to 10 000 km 19 23 Above 10 000 km 22 27 Wood briquettes or pellets from wood industry residues (case 2a) 1 to 500 km 9 11 500 to 2 500 km 9 11 2 500 to 10 000 km 10 13 Above 10 000 km 14 17 Wood briquettes or pellets from wood industry residues (case 3a) 1 to 500 km 3 4 500 to 2 500 km 3 4 2 500 to 10 000 5 6 Above 10 000 km 8 10 Case 1 refers to processes in which a Natural Gas boiler is used to provide the process heat to the pellet mill. Process electricity is purchased from the grid. Case 2a refers to processes in which a boiler fuelled with wood chips is used to provide the process heat to the pellet mill. Process electricity is purchased from the grid. Case 3a refers to processes in which a CHP, fuelled with wood chips, is used to provide heat and electricity to the pellet mill. Biomass fuel production system Transport distance Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) Agricultural Residues with density < 0,2 t/m3 (17) 1 to 500 km 4 4 500 to 2 500 km 8 9 2 500 to 10 000 km 15 18 Above 10 000 km 29 35 Agricultural Residues with density > 0,2 t/m3 (18) 1 to 500 km 4 4 500 to 2 500 km 5 6 2 500 to 10 000 km 8 10 Above 10 000 km 15 18 Straw pellets 1 to 500 km 8 10 500 to 10 000 km 10 12 Above 10 000 km 14 16 Bagasse briquettes 500 to 10 000 km 5 6 Above 10 000 km 9 10 Palm Kernel Meal Above 10 000 km 54 61 Palm Kernel Meal (no CH4 emissions from oil mill) Above 10 000 km 37 40 Typical and default values \u2013 biogas for electricity Biogas production system Technological option Typical value Default value Greenhouse gas emissions (g CO2eq/MJ) Greenhouse gas emissions (g CO2eq/MJ) Biogas for electricity from wet manure Case 1 Open digestate (19) \u2013 28 3 Close digestate (20) \u2013 88 \u2013 84 Case 2 Open digestate \u2013 23 10 Close digestate \u2013 84 \u2013 78 Case 3 Open digestate \u2013 28 9 Close digestate \u2013 94 \u2013 89 Biogas for electricity from maize whole plant Case 1 Open digestate 38 47 Close digestate 24 28 Case 2 Open digestate 43 54 Close digestate 29 35 Case 3 Open digestate 47 59 Close digestate 32 38 Biogas for electricity from biowaste Case 1 Open digestate 31 44 Close digestate 9 13 Case 2 Open digestate 37 52 Close digestate 15 21 Case 3 Open digestate 41 57 Close digestate 16 22 Typical and default values for biomethane Biomethane production system Technological option Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) Biomethane from wet manure Open digestate, no off-gas combustion (21) \u2013 20 22 Open digestate, off-gas combustion (22) \u2013 35 1 Close digestate, no off-gas combustion \u2013 88 \u2013 79 Close digestate, off-gas combustion \u2013 103 \u2013 100 Biomethane from maize whole plant Open digestate, no off-gas combustion 58 73 Open digestate, off-gas combustion 43 52 Close digestate, no off-gas combustion 41 51 Close digestate, off-gas combustion 26 30 Biomethane from biowaste Open digestate, no off-gas combustion 51 71 Open digestate, off-gas combustion 36 50 Close digestate, no off-gas combustion 25 35 Close digestate, off-gas combustion 10 14 Typical and default values \u2013 biogas for electricity \u2013 mixtures of manure and maize: greenhouse gas emissions with shares given on a fresh mass basis Biogas production system Technological options Greenhouse gas emissions \u2013 typical value (g CO2eq/MJ) Greenhouse gas emissions \u2013 default value (g CO2eq/MJ) Manure \u2013 Maize 80 % - 20 % Case 1 Open digestate 17 33 Close digestate \u2013 12 \u2013 9 Case 2 Open digestate 22 40 Close digestate \u2013 7 \u2013 2 Case 3 Open digestate 23 43 Close digestate \u2013 9 \u2013 4 Manure \u2013 Maize 70 % - 30 % Case 1 Open digestate 24 37 Close digestate 0 3 Case 2 Open digestate 29 45 Close digestate 4 10 Case 3 Open digestate 31 48 Close digestate 4 10 Manure \u2013 Maize 60 % - 40 % Case 1 Open digestate 28 40 Close digestate 7 11 Case 2 Open digestate 33 47 Close digestate 12 18 Case 3 Open digestate 36 52 Close digestate 12 18 Comments Case 1 refers to pathways in which electricity and heat required in the process are supplied by the CHP engine itself. Case 2 refers to pathways in which the electricity required in the process is taken from the grid and the process heat is supplied by the CHP engine itself. In some Member States, operators are not allowed to claim the gross production for subsidies and case 1 is the more likely configuration. Case 3 refers to pathways in which the electricity required in the process is taken from the grid and the process heat is supplied by a biogas boiler. This case applies to some installations in which the CHP engine is not on-site and biogas is sold (but not upgraded to biomethane). Typical and default values \u2013 biomethane - mixtures of manure and maize: greenhouse gas emissions with shares given on a fresh mass basis Biomethane production system Technological options Typical value Default value (g CO2eq/MJ) (g CO2eq/MJ) Manure \u2013 Maize 80 % - 20 % Open digestate, no off-gas combustion 32 57 Open digestate, off-gas combustion 17 36 Close digestate, no off-gas combustion \u2013 1 9 Close digestate, off-gas combustion \u2013 16 \u2013 12 Manure \u2013 Maize 70 % - 30 % Open digestate, no off-gas combustion 41 62 Open digestate, off-gas combustion 26 41 Close digestate, no off-gas combustion 13 22 Close digestate, off-gas combustion \u2013 2 1 Manure \u2013 Maize 60 % - 40 % Open digestate, no off-gas combustion 46 66 Open digestate, off-gas combustion 31 45 Close digestate, no off-gas combustion 22 31 Close digestate, off-gas combustion 7 10 Where biomethane is used as Compressed Biomethane as a transport fuel, a value of 3,3 g CO2eq/MJ biomethane needs to be added to the typical values and a value of 4,6 g CO2eq/MJ biomethane to the default values. (*1) Case 1 refers to processes in which a natural gas boiler is used to provide the process heat to the pellet mill. Electricity for the pellet mill is supplied from the grid; Case 2a refers to processes in which a woodchips boiler, fed with pre-dried chips, is used to provide process heat. Electricity for the pellet mill is supplied from the grid; Case 3a refers to processes in which a CHP, fed with pre-dried woodchips, is used to provide electricity and heat to the pellet mill. (*2) This group of materials includes agricultural residues with a low bulk density and it comprises materials such as straw bales, oat hulls, rice husks and sugar cane bagasse bales (not exhaustive list). (*3) The group of agricultural residues with higher bulk density includes materials such as corn cobs, nut shells, soybean hulls, palm kernel shells (not exhaustive list). (*4) Case 1 refers to pathways in which electricity and heat required in the process are supplied by the CHP engine itself. Case 2 refers to pathways in which the electricity required in the process is taken from the grid and the process heat is supplied by the CHP engine itself. In some Member States, operators are not allowed to claim the gross production for subsidies and case 1 is the more likely configuration. Case 3 refers to pathways in which the electricity required in the process is taken from the grid and the process heat is supplied by a biogas boiler. This case applies to some installations in which the CHP engine is not on-site and biogas is sold (but not upgraded to biomethane). (1) The values for biogas production from manure include negative emissions for emissions saved from raw manure management. The value of esca considered is equal to \u2013 45 g CO2eq/MJ manure used in anaerobic digestion. (2) Open storage of digestate accounts for additional emissions of CH4 and N2O. The magnitude of those emissions changes with ambient conditions, substrate types and the digestion efficiency. (3) Close storage means that the digestate resulting from the digestion process is stored in a gas-tight tank and that the additional biogas released during storage is considered to be recovered for production of additional electricity or biomethane. No greenhouse gas emissions are included in that process. (4) Maize whole plant means maize harvested as fodder and ensiled for preservation. (*5) The greenhouse gas emissions savings for biomethane only refer to compressed biomethane relative to the fossil fuel comparator for transport of 94 g CO2eq/MJ. (*6) The greenhouse gas emissions savings for biomethane only refer to compressed biomethane relative to the fossil fuel comparator for transport of 94 g CO2eq/MJ. (5) This category includes the following categories of technologies for biogas upgrade to biomethane: Pressure Swing Adsorption (PSA), Pressure Water Scrubbing (PWS), Membranes, Cryogenic, and Organic Physical Scrubbing (OPS). It includes an emission of 0,03 MJ CH4/MJ biomethane for the emission of methane in the off-gases. (6) This category includes the following categories of technologies for biogas upgrade to biomethane: Pressure Water Scrubbing (PWS) when water is recycled, Pressure Swing Adsorption (PSA), Chemical Scrubbing, Organic Physical Scrubbing (OPS), Membranes and Cryogenic upgrading. No methane emissions are considered for this category (the methane in the off-gas is combusted, if any). (7) Heat or waste heat is used to generate cooling (chilled air or water) through absorption chillers. Therefore, it is appropriate to calculate only the emissions associated to the heat produced, per MJ of heat, irrespectively if the end-use of the heat is actual heating or cooling via absorption chillers. (8) The formula for calculating greenhouse gas emissions from the extraction or cultivation of raw materials eec describes cases where feedstock is converted into biofuels in one step. For more complex supply chains, adjustments are needed for calculating greenhouse gas emissions from the extraction or cultivation of raw materials eec for intermediate products. (9) Measurements of soil carbon can constitute such evidence, e.g. by a first measurement in advance of the cultivation and subsequent ones at regular intervals several years apart. In such a case, before the second measurement is available, increase in soil carbon would be estimated on the basis of representative experiments or soil models. From the second measurement onwards, the measurements would constitute the basis for determining the existence of an increase in soil carbon and its magnitude. (10) The quotient obtained by dividing the molecular weight of CO2 (44,010 g/mol) by the molecular weight of carbon (12,011 g/mol) is equal to 3,664. (11) Cropland as defined by IPCC. (12) Perennial crops are defined as multi-annual crops, the stem of which is usually not annually harvested such as short rotation coppice and oil palm. (13) Commission Decision 2010/335/EU of 10 June 2010 on guidelines for the calculation of land carbon stocks for the purpose of Annex V to Directive 2009/28/EC (OJ L 151, 17.6.2010, p. 19). (14) The values for biogas production from manure include negative emissions for emissions saved from raw manure management. The value of esca considered is equal to \u2013 45 g CO2eq/MJ manure used in anaerobic digestion. (15) Maize whole plant means maize harvested as fodder and ensiled for preservation. (16) Transport of agricultural raw materials to the transformation plant is, according to the methodology provided in the Commission's report of 25 February 2010 on sustainability requirements for the use of solid and gaseous biomass sources in electricity, heating and cooling, included in the \u2018cultivation\u2019 value. The value for transport of maize silage accounts for 0,4 g CO2eq/MJ biogas. (17) This group of materials includes agricultural residues with a low bulk density and it comprises materials such as straw bales, oat hulls, rice husks and sugar cane bagasse bales (not exhaustive list). (18) The group of agricultural residues with higher bulk density includes materials such as corn cobs, nut shells, soybean hulls, palm kernel shells (not exhaustive list). (19) Open storage of digestate accounts for additional emissions of methane which change with the weather, the substrate and the digestion efficiency. In these calculations the amounts are taken to be equal to 0,05 MJ CH4/MJ biogas for manure, 0,035 MJ CH4/MJ biogas for maize and 0,01 MJ CH4/MJ biogas for biowaste. (20) Close storage means that the digestate resulting from the digestion process is stored in a gas tight tank and the additional biogas released during storage is considered to be recovered for production of additional electricity or biomethane. (21) This category includes the following categories of technologies for biogas upgrade to biomethane: Pressure Swing Adsorption (PSA), Pressure Water Scrubbing (PWS), Membranes, Cryogenic, and Organic Physical Scrubbing (OPS). It includes an emission of 0,03 MJ CH4/MJ biomethane for the emission of methane in the off-gases. (22) This category includes the following categories of technologies for biogas upgrade to biomethane: Pressure Water Scrubbing (PWS) when water is recycled, Pressure Swing Adsorption (PSA), Chemical Scrubbing, Organic Physical Scrubbing (OPS), Membranes and Cryogenic upgrading. No methane emissions are considered for this category (the methane in the off-gas is combusted, if any). ANNEX VII ACCOUNTING OF ENERGY FROM HEAT PUMPS The amount of aerothermal, geothermal or hydrothermal energy captured by heat pumps to be considered to be energy from renewable sources for the purposes of this Directive, ERES, shall be calculated in accordance with the following formula: ERES = Qusable * (1 \u2013 1/SPF) where \u2014 = Qusable = the estimated total usable heat delivered by heat pumps fulfilling the criteria referred to in Article 7(4), implemented as follows: Only heat pumps for which SPF > 1,15 * 1/\u03b7 shall be taken into account, \u2014 = SPF = the estimated average seasonal performance factor for those heat pumps, \u2014 = \u03b7 = the ratio between total gross production of electricity and the primary energy consumption for the production of electricity and shall be calculated as an EU average based on Eurostat data. ANNEX VIII PART A. PROVISIONAL ESTIMATED INDIRECT LAND-USE CHANGE EMISSIONS FROM BIOFUEL, BIOLIQUID AND BIOMASS FUEL FEEDSTOCK (g CO2eq/MJ) (1) Feedstock group Mean (2) Interpercentile range derived from the sensitivity analysis (3) Cereals and other starch-rich crops 12 8 to 16 Sugars 13 4 to 17 Oil crops 55 33 to 66 PART B. BIOFUELS, BIOLIQUIDS AND BIOMASS FUELS FOR WHICH THE ESTIMATED INDIRECT LAND-USE CHANGE EMISSIONS ARE CONSIDERED TO BE ZERO Biofuels, bioliquids and biomass fuels produced from the following feedstock categories will be considered to have estimated indirect land-use change emissions of zero: (1) feedstocks which are not listed under part A of this Annex. (2) feedstocks, the production of which has led to direct land-use change, namely, a change from one of the following IPCC land cover categories: forest land, grassland, wetlands, settlements, or other land, to cropland or perennial cropland (4). In such a case a direct land-use change emission value (el) should have been calculated in accordance with point 7 of part C of Annex V. (1) The mean values reported here represent a weighted average of the individually modelled feedstock values. The magnitude of the values in the Annex is sensitive to the range of assumptions (such as treatment of co-products, yield developments, carbon stocks and displacement of other commodities) used in the economic models developed for their estimation. Although it is therefore not possible to fully characterise the uncertainty range associated with such estimates, a sensitivity analysis conducted on the results based on a random variation of key parameters, a so-called Monte Carlo analysis, was conducted. (2) The mean values included here represent a weighted average of the individually modelled feedstock values. (3) The range included here reflects 90 % of the results using the fifth and ninety-fifth percentile values resulting from the analysis. The fifth percentile suggests a value below which 5 % of the observations were found (namely, 5 % of total data used showed results below 8, 4, and 33 g CO2eq/MJ). The ninety-fifth percentile suggests a value below which 95 % of the observations were found (namely, 5 % of total data used showed results above 16, 17, and 66 g CO2eq/MJ). (4) Perennial crops are defined as multi-annual crops, the stem of which is usually not annually harvested such as short rotation coppice and oil palm. ANNEX IX Part A. Feedstocks for the production of biogas for transport and advanced biofuels, the contribution of which towards the minimum shares referred to in the first and fourth subparagraphs of Article 25(1) may be considered to be twice their energy content: (a) Algae if cultivated on land in ponds or photobioreactors; (b) Biomass fraction of mixed municipal waste, but not separated household waste subject to recycling targets under point (a) of Article 11(2) of Directive 2008/98/EC; (c) Biowaste as defined in point (4) of Article 3 of Directive 2008/98/EC from private households subject to separate collection as defined in point (11) of Article 3 of that Directive; (d) Biomass fraction of industrial waste not fit for use in the food or feed chain, including material from retail and wholesale and the agro-food and fish and aquaculture industry, and excluding feedstocks listed in part B of this Annex; (e) Straw; (f) Animal manure and sewage sludge; (g) Palm oil mill effluent and empty palm fruit bunches; (h) Tall oil pitch; (i) Crude glycerine; (j) Bagasse; (k) Grape marcs and wine lees; (l) Nut shells; (m) Husks; (n) Cobs cleaned of kernels of corn; (o) Biomass fraction of wastes and residues from forestry and forest-based industries, namely, bark, branches, pre-commercial thinnings, leaves, needles, tree tops, saw dust, cutter shavings, black liquor, brown liquor, fibre sludge, lignin and tall oil; (p) Other non-food cellulosic material; (q) Other ligno-cellulosic material except saw logs and veneer logs. Part B. Feedstocks for the production of biofuels and biogas for transport, the contribution of which towards the minimum share established in the first subparagraph of Article 25(1) shall be limited and may be considered to be twice their energy content: (a) Used cooking oil; (b) Animal fats classified as categories 1 and 2 in accordance with Regulation (EC) No 1069/2009. ANNEX X PART A Repealed Directive with a list of the successive amendments thereto (referred to in Article 37) Directive 2009/28/EC of the European Parliament and of the Council (OJ L 140, 5.6.2009, p. 16) Council Directive 2013/18/EU (OJ L 158, 10.6.2013, p. 230) Directive (EU) 2015/1513 of the European Parliament and of the Council (OJ L 239, 15.9.2015, p. 1) Only Article 2 PART B Time-limits for transposition into national law (referred to in Article 36) Directive Time-limit for transposition 2009/28/EC 25 June 2009 2013/18/EU 1 July 2013 (EU) 2015/1513 10 September 2017 ANNEX XI Correlation table Directive 2009/28/EC This Directive Article 1 Article 1 Article 2, first subparagraph Article 2, first subparagraph Article 2, second subparagraph, introductory wording Article 2, second subparagraph, introductory wording Article 2, second subparagraph, point (a) Article 2, second subparagraph, point (1) Article 2, second subparagraph, point (b) \u2014 \u2014 Article 2, second subparagraph, point (2) Article 2, second subparagraph, point (c) Article 2, second subparagraph, point (3) Article 2, second subparagraph, point (d) \u2014 Article 2, second subparagraph, points (e), (f), (g), (h), (i), (j), (k), (l), (m), (n), (o), (p), (q), (r), (s), (t), (u), (v) and (w) Article 2, second subparagraph, points (24), (4), (19), (32), (33), (12), (5), (6), (45), (46), (47), (23), (39), (41), (42), (43), (36), (44) and (37) \u2014 Article 2, second subparagraph, points (7), (8), (9), (10), (11), (13), (14), (15), (16), (17), (18), (20), (21), (22), (25), (26), (27), (28), (29), (30), (31), (34), (35), (38) and (40) Article 3 \u2014 \u2014 Article 3 Article 4 \u2014 \u2014 Article 4 \u2014 Article 5 \u2014 Article 6 Article 5(1) Article 7(1) Article 5(2) \u2014 Article 5(3) Article 7(2) Article 5(4), first, second, third and fourth subparagraphs Article 7(3), first, second, third and fourth subparagraphs \u2014 Article 7(3), fifth and sixth subparagraphs \u2014 Article 7(4) Article 5(5), Article 27(1), first subparagraph, point (c) Article 5(6) and (7) Article 7(5) and (6) Article 6(1) Article 8(1) \u2014 Article 8(2) and (3) Article 6(2) and (3) Article 8(4) and (5) Article 7(1), (2), (3), (4) and (5) Article 9(1), (2), (3), (4) and (5) \u2014 Article 9(6) Article 8 Article 10 Article 9(1) Article 11(1) Article 9(2), first subparagraph, points (a), (b) and (c) Article 11(2), first subparagraph, points (a), (b) and (c) \u2014 Article 11(2), first subparagraph, point (d) Article 10 Article 12 Article 11(1), (2) and (3) Article 13(1), (2) and (3) \u2014 Article 13(4) Article 12 Article 14 Article 13(1), first subparagraph Article 15(1), first subparagraph Article 13(1), second subparagraph Article 15(1), second subparagraph Article 13(1), second subparagraph, points (a) and (b) \u2014 Article 13(1), second subparagraph, points (c), (d), (e) and (f) Article 15(1), second subparagraph, points (a), (b), (c) and (d) Article 13(2), (3), (4) and (5) Article 15(2), (3), (4) and (5) Article 13(6), first subparagraph Article 15(6), first subparagraph Article 13(6), second, third, fourth and fifth subparagraphs \u2014 \u2014 Article 15, (7) and (8) \u2014 Article 16 \u2014 Article 17 Article 14 Article 18 Article 15(1) Article 19(1) Article 15(2), first, second and third subparagraphs Article 19(2) first, second and third subparagraphs \u2014 Article 19(2), fourth and fifth subparagraphs Article 15(2), fourth subparagraph Article 19(2), sixth subparagraph Article 15(3) \u2014 \u2014 Article 19(3) and (4) Article 15(4) and (5) Article 19(5) and (6) Article 15(6), first subparagraph, point (a) Article 19(7), first subparagraph, point (a) Article 15(6), first subparagraph, point (b)(i) Article 19(7), first subparagraph, point (b)(i) \u2014 Article 19(7), first subparagraph, point (b)(ii) Article 15(6), first subparagraph, point (b)(ii) Article 19(7), first subparagraph, point (b)(iii) Article 15(6), first subparagraph, points (c), (d), (e) and (f) Article 19(7), first subparagraph, points (c), (d), (e) and (f) \u2014 Article 19(7), second subparagraph Article 15(7) Article 19(8) Article 15(8) \u2014 Article 15(9) and (10) Article 19(9) and (10) \u2014 Article 19(11) Article 15(11) Article 19(12) Article 15(12) \u2014 \u2014 Article 19(13) Article 16(1), (2), (3), (4), (5), (6), (7) and (8) \u2014 Article 16(9), (10) and (11) Article 20(1), (2) and (3) \u2014 Article 21 \u2014 Article 22 \u2014 Article 23 \u2014 Article 24 \u2014 Article 25 \u2014 Article 26 \u2014 Article 27 \u2014 Article 28 Article 17(1), first and second subparagraphs Article 29(1), first and second subparagraphs \u2014 Article 29(1), third, fourth and fifth subparagraphs \u2014 Article 29(2) Article 17(2), first and second subparagraphs \u2014 Article 17(2), third subparagraph Article 29(10), third subparagraph Article 17(3), first subparagraph, point (a) Article 29(3), first subparagraph, point (a) \u2014 Article 29(3), first subparagraph, point (b) Article 17(3), first subparagraph, points (b) and (c) Article 29(3), first subparagraph, points (c) and (d) \u2014 Article 29(3), second subparagraph Article 17(4) Article 29(4) Article 17(5) Article 29(5) Article 17(6) and (7) \u2014 \u2014 Article 29(6), (7), (8), (9), (10) and (11) Article 17(8) Article 29(12) Article 17(9) \u2014 \u2014 Article 29(13) and (14) Article 18(1), first subparagraph Article 30(1), first subparagraph Article 18(1), first subparagraph, points (a), (b) and (c) Article 30(1), first subparagraph, points (a), (c) and (d) \u2014 Article 30(1), first subparagraph, point (b) \u2014 Article 30(1), second subparagraph Article 18(2) \u2014 \u2014 Article 30(2) Article 18(3), first subparagraph Article 30(3), first subparagraph Article 18(3), second and third subparagraphs \u2014 Article 18(3), fourth and fifth subparagraphs Article 30(3), second and third subparagraphs Article 18(4), first subparagraph \u2014 Article 18(4), second and third subparagraphs Article 30(4), first and second subparagraphs Article 18(4), fourth subparagraph \u2014 Article 18(5), first and second subparagraphs Article 30(7), first and second subparagraphs Article 18(5), third subparagraph Article 30(8), first and second subparagraphs Article 18(5), fourth subparagraph Article 30(5), third subparagraph \u2014 Article 30(6), first subparagraph Article 18(5), fifth subparagraph Article 30(6), second subparagraph Article 18(6), first and second subparagraphs Article 30(5), first and second subparagraphs Article 18(6), third subparagraph \u2014 Article 18(6), fourth subparagraph Article 30(6), third subparagraph \u2014 Article 30(6), fourth subparagraph Article 18(6), fifth subparagraph Article 30(6), fifth subparagraph Article 18(7) Article 30(9), first subparagraph \u2014 Article 30(9), second subparagraph Article 18(8) and (9) \u2014 \u2014 Article 30(10) Article 19(1), first subparagraph Article 31(1), first subparagraph Article 19(1), first subparagraph, points (a), (b) and (c) Article 31(1), first subparagraph, points (a), (b) and (c) \u2014 Article 31(1), first subparagraph, point (d) Article 19(2), (3) and (4) Article 31(2), (3) and (4) Article 19(5) \u2014 Article 19(7), first subparagraph Article 31(5), first subparagraph Article 19(7), first subparagraph, first, second third and fourth indents \u2014 Article 19(7), second and third subparagraphs Article 31(5), second and third subparagraphs Article 19(8) Article 31(6) Article 20 Article 32 Article 22 \u2014 Article 23(1) and (2) Article 33(1) and (2) Article 23(3), (4), (5), (6), (7) and (8) \u2014 Article 23(9) Article 33(3) Article 23(10) Article 33(4) Article 24 \u2014 Article 25(1) Article 34(1) Article 25(2) Article 34(2) Article 25(3) Article 34(3) Article 25a(1) Article 35(1) Article 25a(2) Article 35(2) and (3) Article 25a(3) Article 35(4) \u2014 Article 35(5) Article 25a(4) and (5) Article 35(6) and (7) Article 26 \u2014 Article 27 Article 36 \u2014 Article 37 Article 28 Article 38 Article 29 Article 39 Annex I Annex I Annex II Annex II Annex III Annex III Annex IV Annex IV Annex V Annex V Annex VI \u2014 \u2014 Annex VI Annex VII Annex VII Annex VIII Annex VIII Annex IX Annex IX \u2014 Annex X \u2014 Annex XI", "summary": "Renewable energy Renewable energy SUMMARY OF: Directive (EU) 2018/2001 on the promotion of the use of energy from renewable sources WHAT IS THE AIM OF THE DIRECTIVE? It recasts and repeals previous legislation (Directive 2009/28/EC, Directive (EU) 2015/1513 and Council Directive 2013/18/EU). It establishes a common system to promote energy from renewable sources* across the different sectors. In particular, it aims to: set a binding EU target for its share in the energy mix in 2030;regulate self-consumption for the first time; andestablish a common set of rules for the use of renewables in electricity, heating and cooling, and transport in the EU. The increased use of energy from renewable sources will be crucial to combat climate change, protect our environment and reduce our energy dependency, as well as to contribute to the EU\u2019s technological and industrial leadership and the creation of jobs and growth, including in rural and isolated areas. KEY POINTS Promoting renewable forms of energy is one of the goals of EU energy policy. The increased use of energy from renewable sources is an important part of the package of measures needed to reduce greenhouse gas emissions and to comply with the 2015 Paris Agreement on Climate Change and the EU policy framework for climate and energy (2020 to 2030). This recast directive, along with the revised Energy Efficiency Directive and a new Governance Regulation, is part of the Clean Energy for All Europeans package, which aims to provide new, comprehensive rules on energy regulation for the next decade. The directive: ensures that the EU\u2019s binding target is achieved cost-effectively; establishes a stable, market-oriented European approach to renewable electricity; provides long-term certainty for investors and speeds up procedures for permits to build projects; enables consumers to take part in the energy transition with the right to produce their own renewable energy; increasing the use of renewables in the heating and cooling and the transport sectors; strengthens EU sustainability criteria for bioenergy. The directive includes: a binding EU overall target for 2030 of at least 32% of energy from renewable sources; rules for cost-effective and market-based financial support for electricity from renewable sources; protection of support schemes from modifications which put existing projects at risk; cooperation mechanisms between EU countries, and between EU countries and non-EU countries; simplification of administrative procedures for renewables projects (including one-stop-shops, time-limits, and digitalisation); an improved guarantee of origin system, extended to all renewables; rules allowing consumers to produce their own electricity, individually or as part of renewable energy communities, without undue restrictions; in the heating and cooling sector: an annual increase of 1.3 percentage points in the share of renewable energy in the sectorthe right for consumers to disconnect from inefficient district heating and cooling systems andthird-party access for suppliers of renewables and waste heat and cooling to district heating and cooling networks; in the transport sector: a binding target of 14% witha specific sub-target for advanced biofuels of 3.5% andcaps on conventional biofuels and on high indirect land use change risk* biofuels; strengthened EU sustainability criteria for bioenergy, by extending their scope to cover all fuels produced from biomass regardless of their final energy use. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 24 December 2018 and has to become law in EU countries by 30 June 2021. BACKGROUND For more information, see: Renewable energy (European Commission). KEY TERMS Energy from renewable sources: energy from renewable non-fossil sources, such as wind, solar (thermal and photovoltaic), aerothermal, geothermal, hydrothermal, ambient heat, tide, wave and other ocean energy, hydropower, biomass, landfill gas, sewage treatment plant gas and biogases. Indirect land use change risk: changes in land use are brought about by growing more crops for ethanol or biodiesel production in response to the increased global demand for biofuels. There can be unintended consequences, including releasing more carbon emissions. MAIN DOCUMENT Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (recast) (OJ L 328, 21.12.2018, pp. 82-209) RELATED DOCUMENTS Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, pp. 1-77) Directive (EU) 2018/2002 of the European Parliament and of the Council of 11 December 2018 amending Directive 2012/27/EU on energy efficiency (OJ L 328, 21.12.2018, pp. 210-230) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, pp. 1-56) See consolidated version. Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, pp. 16-62) last update 31.01.2019"}
{"article": "17.12.2018 EN Official Journal of the European Union L 321/36 DIRECTIVE (EU) 2018/1972 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 establishing the European Electronic Communications Code (Recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Directives 2002/19/EC (4), 2002/20/EC (5), 2002/21/EC (6) and 2002/22/EC (7) of the European Parliament and of the Council have been substantially amended. Since further amendments are to be made, those Directives should be recast in the interests of clarity. (2) The functioning of the five Directives which are part of the existing regulatory framework for electronic communications networks and services, namely Directives 2002/19/EC, 2002/20/EC, 2002/21/EC and 2002/22/EC, and Directive 2002/58/EC of the European Parliament and of the Council (8), is subject to periodic review by the Commission, with a view, in particular, to determining the need for modification in light of technological and market developments. (3) In its communication or 6 May 2015 setting out a Digital Single Market Strategy for Europe, the Commission stated that its review of the telecommunications framework would focus on measures that aim to provide incentives for investment in high-speed broadband networks, bring a more consistent internal market approach to radio spectrum policy and management, deliver conditions for a true internal market by tackling regulatory fragmentation, ensure effective protection of consumers, a level playing field for all market players and consistent application of the rules, as well as provide a more effective regulatory institutional framework. (4) This Directive is part of a \u2018Regulatory Fitness\u2019 (REFIT) exercise, the scope of which includes four Directives, namely 2002/19/EC, 2002/20/EC, 2002/21/EC and 2002/22/EC, and Regulation (EC) No 1211/2009 of the European Parliament and of the Council (9). Each of those Directives contains measures applicable to providers of electronic communications networks and of electronic communications services, consistently with the regulatory history of the sector under which undertakings were vertically integrated, namely, active in both the provision of networks and of services. The review offers an occasion to recast the four Directives in order to simplify the current structure with a view to reinforcing its consistency and accessibility in relation to the REFIT objective. It also offers the possibility to adapt the structure to the new market reality, where the provision of communications services is no longer necessarily bundled to the provision of a network. As provided in the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts (10), recasting consists in the adoption of a new legal act which incorporates in a single text both the substantive amendments which it makes to an earlier act and the unchanged provisions of that act. The proposal for recasting deals with the substantive amendments which it makes to an earlier act, and on a secondary level, includes the codification of the unchanged provisions of the earlier act with those substantive amendments. (5) This Directive creates a legal framework to ensure freedom to provide electronic communications networks and services, subject only to the conditions laid down in this Directive and to any restrictions in accordance with Article 52(1) of the Treaty on the Functioning of the European Union (TFEU), in particular measures regarding public policy, public security and public health, and consistent with Article 52(1) of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019). (6) This Directive is without prejudice to the possibility for each Member State to take the necessary measures to ensure the protection of its essential security interests, to safeguard public policy and public security, and to permit the investigation, detection and prosecution of criminal offences, taking into account that any limitation to the exercise of the rights and freedoms recognised by the Charter, in particular in Articles 7, 8 and 11 thereof, such as limitations regarding the processing of data, are to be provided for by law, respect the essence of those rights and freedoms and be subject to the principle of proportionality, in accordance with Article 52(1) of the Charter. (7) The convergence of the telecommunications, media and information technology sectors means that all electronic communications networks and services should be covered to the extent possible by a single European electronic communications code established by means of a single Directive, with the exception of matters better dealt with through directly applicable rules established by means of regulations. It is necessary to separate the regulation of electronic communications networks and services from the regulation of content. Therefore, this Directive does not cover the content of services delivered over electronic communications networks using electronic communications services, such as broadcasting content, financial services and certain information society services, and is without prejudice to measures taken at Union or national level in respect of such services, in accordance with Union law, in order to promote cultural and linguistic diversity and to ensure the defence of media pluralism. The content of television programmes is covered by Directive 2010/13/EU of the European Parliament and of the Council (11). The regulation of audiovisual policy and content aims at achieving general interest objectives, such as freedom of expression, media pluralism, impartiality, cultural and linguistic diversity, social inclusion, consumer protection and the protection of minors. The separation between the regulation of electronic communications and the regulation of content does not affect the taking into account of the links existing between them, in particular in order to guarantee media pluralism, cultural diversity and consumer protection. Within the limits of their competences, competent authorities should contribute to ensuring the implementation of policies aiming to promote those objectives. (8) This Directive does not affect the application to radio equipment of Directive 2014/53/EU of the European Parliament and of the Council (12), but does cover car radio and consumer radio receivers, and consumer digital television equipment. (9) In order to allow national regulatory and other competent authorities to meet the objectives set out in this Directive, in particular concerning end-to-end interoperability, the scope of the Directive should cover certain aspects of radio equipment as defined in Directive 2014/53/EU and consumer equipment used for digital television, in order to facilitate access for end-users with disabilities. It is important for national regulatory and other competent authorities to encourage network operators and equipment manufacturers to cooperate in order to facilitate access by end-users with disabilities to electronic communications services. The non-exclusive use of radio spectrum for the self-use of radio terminal equipment, although not related to an economic activity, should also be the subject of this Directive in order to ensure a coordinated approach with regard to their authorisation regime. (10) Certain electronic communications services under this Directive could also fall within the scope of the definition of \u2018information society service\u2019 set out in Article 1 of Directive (EU) 2015/1535 of the European Parliament and of the Council (13). The provisions of that Directive that govern information society services apply to those electronic communications services to the extent that this Directive or other Union legal acts do not contain more specific provisions applicable to electronic communications services. However, electronic communications services such as voice telephony, messaging services and electronic mail services are covered by this Directive. The same undertaking, for example an internet service provider, can offer both an electronic communications service, such as access to the internet, and services not covered by this Directive, such as the provision of web-based and not communications-related content. (11) The same undertaking, for example a cable operator, can offer both an electronic communications service, such as the conveyance of television signals, and services not covered under this Directive, such as the commercialisation of an offer of sound or television broadcasting content services, and therefore additional obligations can be imposed on such an undertaking in relation to its activity as a content provider or distributor, in accordance with provisions other than those of this Directive, without prejudice to the conditions laid in an annex to this Directive. (12) The regulatory framework should cover the use of radio spectrum by all electronic communications networks, including the emerging self-use of radio spectrum by new types of networks consisting exclusively of autonomous systems of mobile radio equipment that is connected via wireless links without a central management or centralised network operator, and not necessarily within the exercise of any specific economic activity. In the developing 5G wireless communications environment, such networks are likely to develop in particular outside buildings and on the roads, for transport, energy, research and development, eHealth, public protection and disaster relief, the Internet of Things, machine-to-machine and connected cars. As a result, the application by Member States, based on Article 7 of Directive 2014/53/EU, of additional national requirements regarding the putting into service or use of such radio equipment, or both, in relation to the effective and efficient use of radio spectrum and avoidance of harmful interference should reflect the principles of the internal market. (13) The requirements concerning the capabilities of electronic communications networks are constantly increasing. While in the past the focus was mainly on growing bandwidth available overall and to each individual user, other parameters such as latency, availability and reliability are becoming increasingly important. The current response towards that demand is to bring optical fibre closer and closer to the user, and future \u2018very high capacity networks\u2019 require performance parameters which are equivalent to those that a network based on optical fibre elements at least up to the distribution point at the serving location can deliver. In the case of fixed-line connection, this corresponds to network performance equivalent to that achievable by an optical fibre installation up to a multi-dwelling building, considered to be the serving location. In the case of wireless connection, this corresponds to network performance similar to that achievable based on an optical fibre installation up to the base station, considered to be the serving location. Variations in end-users\u2019 experience which are due to the different characteristics of the medium by which the network ultimately connects with the network termination point should not be taken into account for the purposes of establishing whether a wireless network could be considered as providing similar network performance. In accordance with the principle of technology neutrality, other technologies and transmission media should not be excluded, where they compare with that baseline scenario in terms of their capabilities. The roll-out of such \u2018very high capacity networks\u2019 is likely to further increase the capabilities of networks and pave the way for the roll-out of future wireless network generations based on enhanced air interfaces and a more densified network architecture. (14) Definitions need to be adjusted to ensure that they are in line with the principle of technology neutrality and to keep pace with technological development, including new forms of network management such as through software emulation or software-defined networks. Technological and market evolution has brought networks to move to internet protocol (IP) technology, and enabled end-users to choose between a range of competing voice service providers. Therefore, the term \u2018publicly available telephone service\u2019, which is exclusively used in Directive 2002/22/EC and widely perceived as referring to traditional analogue telephone services, should be replaced by the more current and technological neutral term \u2018voice communications service\u2019. Conditions for the provision of a service should be separated from the actual definitional elements of a voice communications service, namely, a publicly available electronic communications service for originating and receiving, directly or indirectly, national or national and international calls through a number or numbers in a national or international numbering plan, whether such a service is based on circuit switching or packet switching technology. It is the nature of such a service that it is bidirectional, enabling both parties to communicate. A service which does not fulfil all those conditions, such as for example a \u2018click-through\u2019 application on a customer service website, is not such a service. Voice communications services also include means of communication specifically intended for end-users with disabilities using text relay or total conversation services. (15) The services used for communications purposes, and the technical means of their delivery, have evolved considerably. End-users increasingly substitute traditional voice telephony, text messages (SMS) and electronic mail conveyance services by functionally equivalent online services such as Voice over IP, messaging services and web-based e-mail services. In order to ensure that end-users and their rights are effectively and equally protected when using functionally equivalent services, a future-oriented definition of electronic communications services should not be purely based on technical parameters but rather build on a functional approach. The scope of necessary regulation should be appropriate to achieve its public interest objectives. While \u2018conveyance of signals\u2019 remains an important parameter for determining the services falling into the scope of this Directive, the definition should cover also other services that enable communication. From an end-user\u2019s perspective it is not relevant whether a provider conveys signals itself or whether the communication is delivered via an internet access service. The definition of electronic communications services should therefore contain three types of services which may partly overlap, that is to say internet access services as defined in point (2) of Article 2 of Regulation (EU) 2015/2120 of the European Parliament and of the Council (14), interpersonal communications services as defined in this Directive, and services consisting wholly or mainly in the conveyance of signals. The definition of electronic communications service should eliminate ambiguities observed in the implementation of the definition as it existed prior to the adoption of this Directive and allow a calibrated provision-by-provision application of the specific rights and obligations contained in the framework to the different types of services. The processing of personal data by electronic communications services, whether as remuneration or otherwise, should comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (15). (16) In order to fall within the scope of the definition of electronic communications service, a service needs to be provided normally in exchange for remuneration. In the digital economy, market participants increasingly consider information about users as having a monetary value. Electronic communications services are often supplied to the end-user not only for money, but increasingly and in particular for the provision of personal data or other data. The concept of remuneration should therefore encompass situations where the provider of a service requests and the end-user knowingly provides personal data within the meaning of Regulation (EU) 2016/679 or other data directly or indirectly to the provider. It should also encompass situations where the end-user allows access to information without actively supplying it, such as personal data, including the IP address, or other automatically generated information, such as information collected and transmitted by a cookie. In line with the case-law of the Court of Justice of the European Union (Court of Justice) on Article 57 TFEU (16), remuneration also exists within the meaning of the TFEU if the service provider is paid by a third party and not by the service recipient. The concept of remuneration should therefore also encompass situations in which the end-user is exposed to advertisements as a condition for gaining access to the service, or situations in which the service provider monetises personal data it has collected in accordance with Regulation (EU) 2016/679. (17) Interpersonal communications services are services that enable interpersonal and interactive exchange of information, covering services like traditional voice calls between two individuals but also all types of emails, messaging services, or group chats. Interpersonal communications services only cover communications between a finite, that is to say not potentially unlimited, number of natural persons, which is determined by the sender of the communication. Communications involving legal persons should fall within the scope of the definition where natural persons act on behalf of those legal persons or are involved at least on one side of the communication. Interactive communication entails that the service allows the recipient of the information to respond. Services which do not meet those requirements, such as linear broadcasting, video on demand, websites, social networks, blogs, or exchange of information between machines, should not be considered to be interpersonal communications services. In exceptional circumstances a service should not be considered to be an interpersonal communications service if the interpersonal and interactive communication facility is a minor and purely ancillary feature to another service and for objective technical reasons cannot be used without that principal service, and its integration is not a means to circumvent the applicability of the rules governing electronic communications services. As elements of an exemption from the definition the terms \u2018minor\u2019 and \u2018purely ancillary\u2019 should be interpreted narrowly and from an objective end-user\u2019s perspective. An interpersonal communications feature could be considered to be minor where its objective utility for an end-user is very limited and where it is in reality barely used by end-users. An example of a feature that could be considered to fall outside the scope of the definition of interpersonal communications services might be, in principle, a communication channel in online games, depending on the features of the communication facility of the service. (18) Interpersonal communications services using numbers from national and international numbering plans connect with publicly assigned numbering resources. Those number-based interpersonal communications services comprise both services to which end-users numbers are assigned for the purpose of ensuring end-to-end connectivity and services enabling end-users to reach persons to whom such numbers have been assigned. The mere use of a number as an identifier should not be considered to be equivalent to the use of a number to connect with publicly assigned numbers and should therefore, in itself, not be considered to be sufficient to qualify a service as a number-based interpersonal communications service. Number-independent interpersonal communications services should be subject to obligations only where public interests require that specific regulatory obligations apply to all types of interpersonal communications services, regardless of whether they use numbers for the provision of their service. It is justified to treat number-based interpersonal communications services differently, as they participate in, and hence also benefit from, a publicly assured interoperable ecosystem. (19) The network termination point represents a boundary for regulatory purposes between the regulatory framework for electronic communications networks and services and the regulation of telecommunications terminal equipment. Defining the location of the network termination point is the responsibility of the national regulatory authority. In light of the practice of national regulatory authorities, and given the variety of fixed and wireless topologies, the Body of European Regulators for Electronic Communications (\u2018BEREC\u2019) should, in close cooperation with the Commission, adopt guidelines on common approaches to the identification of the network termination point, in accordance with this Directive, in various concrete circumstances. (20) Technical developments make it possible for end-users to access emergency services not only by voice calls but also by other interpersonal communications services. The concept of emergency communication should therefore cover all interpersonal communications services that allow such emergency services access. It builds on the emergency system elements already enshrined in Union law, namely a public safety answering point (\u2018PSAP\u2019) and a most appropriate PSAP as defined in Regulation (EU) 2015/758 of the European Parliament and of the Council (17), and on emergency services as defined in Commission Delegated Regulation (EU) No 305/2013 (18). (21) National regulatory and other competent authorities should have a harmonised set of objectives and principles to underpin their work, and should, where necessary, coordinate their actions with the authorities of other Member States and with BEREC in carrying out their tasks under this regulatory framework. (22) The tasks assigned to competent authorities by this Directive contribute to the fulfilment of broader policies in the areas of culture, employment, the environment, social cohesion and town and country planning. (23) The regulatory framework should, in addition to the existing three primary objectives of promoting competition, the internal market and end-user interests, pursue an additional connectivity objective, articulated in terms of outcomes: widespread access to and take-up of very high capacity networks for all citizens of the Union and Union businesses on the basis of reasonable price and choice, effective and fair competition, open innovation, efficient use of radio spectrum, common rules and predictable regulatory approaches in the internal market and the necessary sector-specific rules to safeguard the interests of citizens of the Union. For the Member States, the national regulatory and other competent authorities and the stakeholders, that connectivity objective translates, on the one hand, into aiming for the highest capacity networks and services economically sustainable in a given area, and, on the other, into pursuing territorial cohesion, in the sense of convergence in capacity available in different areas. (24) Progress towards the achievement of the general objectives of this Directive should be supported by a robust system of continuous assessment and benchmarking by the Commission of Member States with respect to the availability of very high capacity networks in all major socio-economic drivers such as schools, transport hubs and major providers of public services, and highly digitised businesses, the availability of uninterrupted 5G coverage for urban areas and major terrestrial transport paths, and the availability to all households in each Member State of electronic communications networks which are capable of providing at least 100 Mbps, and which are promptly upgradeable to gigabit speeds. To that end, the Commission should continue monitoring the performance of Member States, including, by way of an example, indexes that summarise relevant indicators on the Union\u2019s digital performance and track the evolution of Member States in digital competitiveness, such as the Digital Economy and Society Index, and, where necessary, establish new methods and new objective, concrete and quantifiable criteria for benchmarking the effectiveness of Member States. (25) The principle that Member States should apply Union law in a technologically neutral fashion, that is to say that a national regulatory or other competent authority should neither impose nor discriminate in favour of the use of a particular type of technology, does not preclude the taking of proportionate steps to promote certain specific services where justified in order to attain the objectives of the regulatory framework, for example digital television as a means for increasing radio spectrum efficiency. Furthermore, that principle does not preclude taking into account that certain transmission media have physical characteristics and architectural features that can be superior in terms of quality of service, capacity, maintenance cost, energy efficiency, management flexibility, reliability, robustness and scalability, and, ultimately, performance, which can be reflected in actions taken with a view to pursuing the various regulatory objectives. (26) Both efficient investment and competition should be encouraged in tandem, in order to increase economic growth, innovation and consumer choice. (27) Competition can best be fostered through an economically efficient level of investment in new and existing infrastructure, complemented by regulation, where necessary, to achieve effective competition in retail services. An efficient level of infrastructure-based competition is the extent of infrastructure duplication at which investors can reasonably be expected to make a fair return based on reasonable expectations about the evolution of market shares. (28) It is necessary to give appropriate incentives for investment in new very high capacity networks that support innovation in content-rich internet services and strengthen the international competitiveness of the Union. Such networks have enormous potential to deliver benefits to consumers and businesses across the Union. It is therefore vital to promote sustainable investment in the development of those new networks, while safeguarding competition, as bottlenecks and barriers to entry remain at the infrastructure level, and boosting consumer choice through regulatory predictability and consistency. (29) This Directive aims to progressively reduce ex ante sector-specific rules as competition in the markets develops and, ultimately, to ensure that electronic communications are governed only by competition law. Considering that the markets for electronic communications have shown strong competitive dynamics in recent years, it is essential that ex ante regulatory obligations are imposed only where there is no effective and sustainable competition on the markets concerned. The objective of ex ante regulatory intervention is to produce benefits for end-users by making retail markets effectively competitive on a sustainable basis. Obligations at wholesale level should be imposed where otherwise one or more retail markets are not likely to become effectively competitive in the absence of those obligations. It is likely that national regulatory authorities are gradually, through the process of market analysis, able to find retail markets to be competitive even in the absence of wholesale regulation, especially taking into account expected improvements in innovation and competition. In such a case, the national regulatory authority should conclude that regulation is no longer needed at wholesale level, and assess the corresponding relevant wholesale market with a view to withdrawing ex ante regulation. In doing so, the national regulatory authority should take into account any leverage effects between wholesale and related retail markets which might require the removal of barriers to entry at the infrastructure level in order to ensure long-term competition at the retail level. (30) Electronic communications are becoming essential for an increasing number of sectors. The Internet of Things is an illustration of how the radio signal conveyance underpinning electronic communications continues to evolve and shape societal and business reality. To derive the greatest benefit from those developments, the introduction and accommodation of new wireless communications technologies and applications in radio spectrum management is essential. As other technologies and applications relying on radio spectrum are equally subject to growing demand, and can be enhanced by integrating or combining them with electronic communications, radio spectrum management should adopt, where appropriate, a cross-sectorial approach to improve the efficient use of radio spectrum. (31) Strategic planning, coordination and, where appropriate, harmonisation at Union level can help ensure that radio spectrum users derive the full benefits of the internal market and that Union interests can be effectively defended globally. For those purposes it should be possible to adopt multiannual radio spectrum policy programmes, where appropriate. The first such programme was established by Decision No 243/2012/EU of the European Parliament and of the Council (19), setting out policy orientations and objectives for the strategic planning and harmonisation of the use of radio spectrum in the Union. It should be possible for those policy orientations and objectives to refer to the availability and efficient use of radio spectrum necessary for the establishment and functioning of the internal market, in accordance with this Directive. (32) National borders are increasingly irrelevant in determining optimal radio spectrum use. Undue fragmentation amongst national policies result in increased costs and lost market opportunities for radio spectrum users and slows down innovation to the detriment of the proper functioning of the internal market and prejudice to consumers and the economy as a whole. (33) The radio spectrum management provisions of this Directive should be consistent with the work of international and regional organisations dealing with radio spectrum management, such as the International Telecommunications Union (ITU) and the European Conference of Postal and Telecommunications Administrations (CEPT), in order to ensure the effective management of and harmonisation of the use of radio spectrum across the Union and between the Member States and other members of the ITU. (34) In accordance with the principle of the separation of regulatory and operational functions, Member States should guarantee the independence of the national regulatory and other competent authorities with a view to ensuring the impartiality of their decisions. This requirement of independence is without prejudice to the institutional autonomy and constitutional obligations of the Member States or to the principle of neutrality with regard to the rules in Member States governing the system of property ownership laid down in Article 345 TFEU. National regulatory and other competent authorities should be in possession of all the necessary resources, in terms of staffing, expertise, and financial means, for the performance of their tasks. (35) Certain tasks pursuant to the Directive, such as ex ante market regulation, including the imposition of obligations for access and interconnection, and the resolution of disputes between undertakings are tasks which should be undertaken only by national regulatory authorities, namely, bodies which are independent both from the sector and from any external intervention or political pressure. Unless otherwise provided, Member States should be able to assign other regulatory tasks provided for in this Directive either to the national regulatory authorities or to other competent authorities. In the course of transposition, Member States should promote the stability of competences of the national regulatory authorities with regard to the assignment of tasks which resulted from the transposition of the Union electronic communications regulatory framework as amended in 2009, in particular those related to market competition or market entry. Where tasks are assigned to other competent authorities, those other competent authorities should seek to consult the national regulatory authorities before taking a decision. Pursuant to the principle of good cooperation, national regulatory and other competent authorities should exchange information for the exercise of their tasks. (36) This Directive does not include substantive provisions on open internet access or roaming and is without prejudice to the allocation of competences to national regulatory authorities in Regulation (EU) No 531/2012 of the European Parliament and of the Council (20) and in Regulation (EU) 2015/2120. However, this Directive provides, in addition, for national regulatory authorities to be competent for assessing and monitoring closely market access and competition issues which potentially affect the rights of end-users to an open internet access. (37) The independence of the national regulatory authorities was strengthened in the review of the electronic communications regulatory framework completed in 2009 in order to ensure a more effective application of the regulatory framework and to increase their authority and the predictability of their decisions. To that end, express provision had to be made in national law to ensure that, in the exercise of its tasks, a national regulatory authority is protected against external intervention or political pressure liable to jeopardise its independent assessment of matters coming before it. Such outside influence makes a national legislative body unsuited to act as a national regulatory authority under the regulatory framework. For that purpose, rules had to be laid down at the outset regarding the grounds for the dismissal of the head of the national regulatory authority in order to remove any reasonable doubt as to the neutrality of that body and its imperviousness to external factors. In order to avoid arbitrary dismissals, dismissed members should have the right to request that the competent courts verify the existence of a valid reason to dismiss, among those provided for in this Directive. Such dismissals should relate only to the personal or professional qualifications of the head or member. It is important that national regulatory authorities have their own budget allowing them, in particular, to recruit a sufficient number of qualified staff. In order to ensure transparency, that budget should be published annually. Within the limits of their budget, they should have autonomy in managing their resources, human and financial. In order to ensure impartiality, Member States that retain ownership of, or control, undertakings contributing to the budget of the national regulatory or other competent authorities through administrative charges should ensure that there is effective structural separation of activities associated with the exercise of ownership or control from the exercise of control over the budget. (38) There is a need to further reinforce the independence of the national regulatory authorities to ensure the imperviousness of its head and members to external pressure, by providing minimum appointment qualifications, and a minimum duration for their mandate. Furthermore, to address the risk of regulatory capture, ensure continuity and enhance independence, Member States should consider limiting the possibility of renewing the mandates of the head or members of the board and set up an appropriate rotation scheme for the board and the top management. This could be arranged, for instance, by appointing the first members of the collegiate body for different periods in order for their mandates, as well as that of their successors, not to lapse at the same moment. (39) National regulatory authorities should be accountable for, and should be required to report on, the way in which they are exercising their tasks. That obligation should normally take the form of an annual reporting obligation rather than ad hoc reporting requests, which, if disproportionate, could limit their independence or hinder them in the exercise of their tasks. Indeed, according to the case-law of the Court of Justice (21), extensive or unconditional reporting obligations may indirectly affect the independence of an authority. (40) Member States should notify the Commission of the identity of the national regulatory and other competent authorities. For authorities competent for granting rights of way, it should be possible to fulfil the notification requirement by a reference to the single information point established pursuant to Directive 2014/61/EU of the European Parliament and of the Council (22). (41) The least onerous authorisation system possible should be used to allow the provision of electronic communications networks and services in order to stimulate the development of new communications services and pan-European communications networks and services and to allow service providers and consumers to benefit from the economies of scale of the internal market. (42) The benefits of the internal market to service providers and end-users can be best achieved by general authorisation of electronic communications networks and of electronic communications services other than number-independent interpersonal communications services, without requiring any explicit decision or administrative act by the national regulatory authority and by limiting any procedural requirements to a declaratory notification only. Where Member States require notification by providers of electronic communications networks or services when they start their activities, such notification should not entail administrative cost for the providers and could be made available via an entry point at the website of the competent authorities. In order to support effective cross-border coordination, in particular for pan-European operators, BEREC should establish and maintain a database of such notifications. Competent authorities should transmit only complete notifications to BEREC. Member States should not impede the provision of networks or services in any way, including on grounds of incompleteness of a notification. (43) Notifications should entail a mere declaration of the provider\u2019s intention to commence the provision of electronic communications networks and services. A provider should be required to complement that declaration only with the information set out in this Directive. Member States should not impose additional or separate notification requirements. (44) Contrary to the other categories of electronic communications networks and services as defined in this Directive, number-independent interpersonal communications services do not benefit from the use of public numbering resources and do not participate in a publicly assured interoperable ecosystem. It is therefore not appropriate to subject those types of services to the general authorisation regime. (45) When granting rights of use for radio spectrum, for numbering resources or rights to install facilities, the competent authorities should inform the undertakings to which they grant such rights of the relevant conditions. Member States should be able to lay down such conditions for the use of radio spectrum in individual rights of use or in the general authorisation. (46) General authorisations should contain only conditions which are specific to the electronic communications sector. They should not be made subject to conditions which are already applicable by virtue of other existing national law, in particular regarding consumer protection, which is not specific to the communications sector. For instance, competent authorities should be able to inform undertakings about the applicable environmental and town-and-country-planning requirements. Conditions imposed under the general authorisation do not affect the determination of applicable law pursuant to Regulation (EC) No 593/2008 of the European Parliament and of the Council (23). (47) The conditions that could be attached to general authorisations should cover specific conditions governing accessibility for end-users with disabilities and the need of public authorities and emergency services to communicate between themselves and with the general public before, during and after major disasters. (48) It is necessary to include the rights and obligations of undertakings under general authorisations explicitly in such authorisations in order to ensure a level playing field throughout the Union and to facilitate cross-border negotiation of interconnection between public electronic communications networks. (49) General authorisations entitle undertakings providing electronic communications networks and services to the public to negotiate interconnection under the conditions of this Directive. Undertakings providing electronic communications networks and services other than to the public can negotiate interconnection on commercial terms. (50) Competent authorities should duly take into account, when attaching conditions to general authorisations and applying administrative charges, situations in which electronic communications networks or services are provided by natural persons on a not-for-profit basis. In the case of electronic communications networks and services not provided to the public it is appropriate to impose fewer and lighter conditions, if any, than are justified for electronic communications networks and services provided to the public. (51) Specific obligations imposed on undertakings providing electronic communications networks and electronic communications services in accordance with Union law by virtue of their designation as having significant market power as defined in this Directive should be imposed separately from the general rights and obligations under the general authorisation. (52) It is possible that undertakings providing electronic communications networks and services need confirmation of their rights under the general authorisation with respect to interconnection and rights of way, in particular to facilitate negotiations with other, regional or local, levels of government or with service providers in other Member States. To that end competent authorities should provide declarations to undertakings either upon request or alternatively as an automatic response to a notification under the general authorisation. Such declarations should not by themselves constitute entitlements to rights, nor should any rights under the general authorisation, rights of use or the exercise of such rights depend upon a declaration. (53) It should be possible to impose administrative charges on undertakings providing electronic communications services in order to finance the activities of the national regulatory or other competent authority in managing the general authorisation system and the granting of rights of use. Such charges should be limited to cover the actual administrative costs for those activities. To that end, transparency should be ensured in the income and expenditure of national regulatory and other competent authorities by means of annual reporting about the total sum of charges collected and the administrative costs incurred, in order to allow undertakings to verify that they are in balance. (54) Systems for administrative charges should not distort competition or create barriers to market entry. A general authorisation system renders it impossible to attribute administrative costs and hence charges to individual undertakings, except for the granting of rights of use for numbering resources, radio spectrum and for rights to install facilities. Any applicable administrative charges should be in line with the principles of a general authorisation system. An example of a fair, simple and transparent alternative for those charge attribution criteria could be a turnover related distribution key. Where administrative charges are very low, flat rate charges, or charges combining a flat rate basis with a turnover related element could also be appropriate. To the extent that the general authorisation system extends to undertakings with very small market shares, such as community-based network providers, or to service providers the business model of which generates very limited revenues even in the case of significant market penetration in terms of volumes, Member States should assess the possibility to establish an appropriate de minimis threshold for the imposition of administrative charges. (55) Member States might need to amend rights, conditions, procedures, charges and fees relating to general authorisations and rights of use where this is objectively justified. Such proposed amendments should be duly notified to all interested parties in good time, giving them adequate opportunity to express their views. Unnecessary procedures should be avoided in the case of minor amendments to existing rights to install facilities or rights of use for radio spectrum or for numbering resources when such amendments do not have an impact on third parties\u2019 interests. Minor amendments to rights and obligations are amendments which are mainly administrative, do not change the substantial nature of the general authorisations and the individual rights of use and thus cannot generate any competitive advantage over other undertakings. (56) Considering the importance of ensuring legal certainty and in order to promote regulatory predictability to provide a safe environment for investments, in particular for new wireless broadband communications, any restriction or withdrawal of any existing rights of use for radio spectrum or for numbering resources or right to install facilities should be subject to predictable and transparent justifications and procedures. Hence, stricter requirements or a notification mechanism could be imposed in particular where rights of use have been assigned pursuant to competitive or comparative procedures and in the case of harmonised radio spectrum bands to be used for wireless broadband electronic communications services (\u2018wireless broadband services\u2019). Justifications referring to effective and efficient use of radio spectrum and technological evolution could rely on technical implementing measures adopted under Decision No 676/2002/EC of the European Parliament and of the Council (24). Furthermore, except where proposed amendments are minor, where general authorisations and individual rights of use for radio spectrum need to be restricted, withdrawn or amended without the consent of the holder of the right, this can take place after consulting interested parties. As restrictions or withdrawals of general authorisations or rights may have significant consequences for their holders, the competent authorities should take particular care and assess in advance the potential harm that such measures may cause before adopting such measures. (57) National regulatory authorities, other competent authorities and BEREC need to gather information from market players in order to carry out their tasks effectively, including assessing the compliance of general terms and conditions with this Directive without suspending the applicability of those terms and conditions during the assessment. It may, by way of exception, also be necessary to gather information from other undertakings active in sectors that are closely related to the electronic communications services sector, such as content providers, that hold information which could be necessary for them to exercise their tasks under Union law. It might also be necessary to gather such information on behalf of the Commission, to allow it to fulfil its respective obligations under Union law. Requests for information should be proportionate and not impose an undue burden on undertakings. Information gathered by national regulatory and other competent authorities should be publicly available, except in so far as it is confidential in accordance with national rules on public access to information and subject to Union and national rules on commercial confidentiality. (58) In order to ensure that national regulatory authorities carry out their regulatory tasks in an effective manner, the data which they gather should include accounting data on the retail markets that are associated with wholesale markets where an undertaking is designated as having significant market power and as such are regulated by the national regulatory authority. The data should also include data which enable the national regulatory authority to assess compliance with conditions attached to rights of use, the possible impact of planned upgrades or changes to network topology on the development of competition or on wholesale products made available to other parties. Information regarding compliance with coverage obligations attached to rights of use for radio spectrum is key to ensure completeness of the geographical surveys of network deployments. In that respect, the competent authority should be able to require that information is provided at disaggregated local level with a granularity adequate to conduct a geographical survey of networks. (59) To alleviate the burden of reporting and information obligations for network and service providers and the competent authority concerned, such obligations should be proportionate, objectively justified and limited to what is strictly necessary. In particular, duplication of requests for information by the competent authority and by BEREC, and the systematic and regular proof of compliance with all conditions under a general authorisation or a right of use, should be avoided. Undertakings should be aware of the intended use of the information sought. Provision of information should not be a condition for market access. For statistical purposes, a notification may be required from providers of electronic communications networks or services when they cease activities. (60) Member States\u2019 obligations to provide information for the defence of Union interests under international agreements as well as reporting obligations under law that is not specific to the electronic communications sector such as competition law should not be affected. (61) It should be possible to exchange information that is considered to be confidential by a competent authority, in accordance with Union and national rules on commercial confidentiality and on the protection of personal data, with the Commission, BEREC and any other authorities where such exchange is necessary for the application of national law transposing this Directive. The information exchanged should be limited to that which is relevant and proportionate to the purpose of such an exchange. (62) Electronic communications broadband networks are becoming increasingly diverse in terms of technology, topology, medium used and ownership. Therefore, regulatory intervention must rely on detailed information regarding network roll-out in order to be effective and to target the areas where it is needed. That information is essential for the purpose of promoting investment, increasing connectivity across the Union and providing information to all relevant authorities and citizens. It should include surveys regarding both deployment of very high capacity networks, as well as significant upgrades or extensions of existing copper or other networks which might not match the performance characteristics of very high capacity networks in all respects, such as roll-out of fibre to the cabinet coupled with active technologies like vectoring. The relevant forecasts should concern periods of up to three years. The level of detail and territorial granularity of the information that competent authorities should gather should be guided by the specific regulatory objective, and should be adequate for the regulatory purposes that it serves. Therefore, the size of the territorial unit will also vary between Member States, depending on the regulatory needs in the specific national circumstances, and on the availability of local data. Level 3 in the Nomenclature of Territorial Units for Statistics (NUTS) is unlikely to be a sufficiently small territorial unit in most circumstances. National regulatory and other competent authorities should be guided by BEREC guidelines on best practice to approach such a task, and such guidelines will be able to rely on the existing experience of national regulatory and/or other competent authorities in conducting geographical surveys of networks roll-out. Without prejudice to commercial confidentiality requirements, competent authorities should, where the information is not already available on the market, make data directly accessible in an open format in accordance with Directive 2003/98/EC of the European Parliament and of the Council (25) and without restrictions on reuse the information gathered in such surveys and should make available tools to end-users as regards quality of service to contribute towards the improvement of their awareness of the available connectivity services. In gathering any of that information, all authorities concerned should respect the principle of confidentiality, and should avoid causing a competitive disadvantage to any undertaking. (63) Bridging the digital divide in the Union is essential to enable all citizens of the Union to have access to the internet and digital services. To that end, in the case of specific and well-defined areas, the relevant authorities should have the possibility to invite undertakings and public authorities to declare their intention to deploy very high capacity networks in these areas, allowing them sufficient time to provide a thoroughly considered response. The information included in the forecasts should reflect the economic prospects of the electronic communications networks sector and investment intentions of undertakings at the time when the data are gathered, in order to allow the identification of available connectivity in different areas. Where an undertaking or public authority declares an intention to deploy in an area, the national regulatory or other competent authority should be able to require other undertakings and public authorities to declare whether or not they intend to deploy very high capacity networks, or significantly upgrade or extend their network to a performance of at least 100 Mbps download speeds in this area. That procedure will create transparency for undertakings and public authorities that have expressed their interest in deploying in this area, so that, when designing their business plans, they can assess the likely competition that they will face from other networks. The positive effect of such transparency relies on market participants responding truthfully and in good faith. (64) While market participants can change their deployment plans for unforeseen, objective and justifiable reasons, competent authorities should intervene, including if public funding is affected, and, where appropriate, impose penalties if they have been provided, knowingly or due to gross negligence, by an undertaking or public authority with misleading erroneous or incomplete information. For the purpose of the relevant provisions on penalties, gross negligence should refer to a situation where an undertaking or a public authority provides misleading, erroneous or incomplete information due to its behaviour or internal organisation which falls significantly below due diligence regarding the information provided. Gross negligence should not require that the undertaking or public authority knows that the information provided is misleading, erroneous or incomplete, but, rather, that it would have known, had it acted or been organised with due diligence. It is important that the penalties are sufficiently dissuasive in light of the negative impact on competition and on publicly funded projects. The provisions on penalties should be without prejudice to any rights to claim compensation for damages in accordance with national law. (65) In the interests of predictable investment conditions, competent authorities should be able to share information with undertakings and public authorities expressing interest in deploying very high capacity networks on whether other types of network upgrades, including those below 100 Mbps download speed, are present or foreseen in the area in question. (66) It is important that national regulatory and other competent authorities consult all interested parties on proposed decisions, give them sufficient time to the complexity of the matter to provide their comments, and take account of their comments before adopting a final decision. In order to ensure that decisions at national level do not have an adverse effect on the functioning of the internal market or other TFEU objectives, national regulatory authorities should also notify certain draft decisions to the Commission and other national regulatory authorities to give them the opportunity to comment. It is appropriate for competent authorities to consult interested parties in the cases defined in this Directive on all draft measures which have an effect on trade between Member States. (67) In the context of a competitive environment, the views of interested parties, including users and consumers, should be taken into account. In order to appropriately address the interests of citizens, Member States should put in place an appropriate consultation mechanism. Such a mechanism could take the form of a body which would, independently of the national regulatory authority and service providers, carry out research into consumer-related issues, such as consumer behaviour and mechanisms for changing suppliers, and which would operate in a transparent manner and contribute to the existing mechanisms for stakeholder consultation. Furthermore, a mechanism could be established for the purpose of enabling appropriate cooperation on issues relating to the promotion of lawful content. Any cooperation procedures agreed pursuant to such a mechanism should, however, not allow for the systematic surveillance of internet use. (68) Out-of-court dispute resolution procedures may constitute a fast and cost-efficient way for end-users to enforce their rights, in particular for consumers and microenterprises and small enterprises as defined in the Annex to Commission Recommendation 2003/361/EC (26). Member States should enable the national regulatory authority or another competent authority responsible for, or at least one independent body with proven expertise in dealing with, end-user rights to act as an alternative dispute resolution entity. With respect to such dispute resolutions, those authorities should not be subject to any instructions. As many Member States have established dispute resolution procedures also for end-users other than consumers, to whom Directive 2013/11/EU of the European Parliament and of the Council (27) does not apply, it is reasonable to maintain the sector-specific dispute resolution procedure for both consumers and, where Member States extend it, also for other end-users, in particular microenterprises and small enterprises. In relation to out-of-court dispute resolution, Member States should be able to maintain or introduce rules that go beyond those laid down by Directive 2013/11/EU in order to ensure a higher level of consumer protection. (69) In the event of a dispute between undertakings in the same Member State in an area covered by this Directive, for example relating to obligations for access and interconnection or to the means of transferring end-user lists, an aggrieved party that has negotiated in good faith but failed to reach agreement should be able to call on the national regulatory authority to resolve the dispute. National regulatory authorities should be able to impose a solution on the parties. The intervention of a national regulatory authority in the resolution of a dispute between providers of electronic communications networks or services or associated facilities in a Member State should seek to ensure compliance with the obligations arising under this Directive. (70) In addition to the rights of recourse granted under Union or national law, there is a need for a simple procedure to be initiated at the request of either party in a dispute, to resolve cross-border disputes between undertakings providing, or authorised to provide, electronic communications networks or services in different Member States. (71) One important task assigned to BEREC is to adopt, where appropriate, opinions in relation to cross-border disputes. National regulatory authorities should therefore fully reflect any opinion submitted by BEREC in their measures imposing any obligation on an undertaking or otherwise resolving the dispute in such cases. (72) Lack of coordination between Member States when organising the use of radio spectrum in their territory can, if not solved through bilateral Member States negotiations, create large-scale interference issues severely impacting on the development of the Digital Single Market. Member States should take all necessary measures to avoid cross-border and harmful interference between them. The Radio Spectrum Policy Group (RSPG) established by Commission Decision 2002/622/EC (28) should be tasked with supporting the necessary cross-border coordination and be the designated forum for resolving disputes between Member States on cross border issues. Building on the RSPG\u2019s proposed solution, an implementing measure is required in some circumstances to resolve cross-border interference definitively or to enforce under Union law a coordinated solution agreed by two or several Member States in bilateral negotiations. Lack of coordination between Member States and countries neighbouring the Union can also create large-scale interference issues. Member States should take appropriate measures to avoid cross-border and harmful interference with countries neighbouring the Union, and cooperate with each other to that end. Upon the request of Member States affected by cross-border interference from third countries, the Union should provide its full support for those Member States. (73) The RSPG is a Commission high-level advisory group which was created by Decision 2002/622/EC to contribute to the development of the internal market and to support the development of a Union-level radio spectrum policy, taking into account economic, political, cultural, strategic, health and social considerations, as well as technical parameters. It should be composed of the heads of the bodies that have overall political responsibility for strategic radio spectrum policy. It should assist and advise the Commission with respect to radio spectrum policy. This should further increase the visibility of radio spectrum policy in the various Union policy areas and help to ensure cross-sectorial consistency at Union and national and level. It should also provide advice to the European Parliament and to the Council upon their request. Moreover, the RSPG should also be the forum for the coordination of implementation by Member States of their obligations related to radio spectrum under this Directive and should play a central role in fields essential for the internal market such as cross-border coordination or standardisation. Technical or expert working groups could also be created to assist plenary meetings, at which strategic policy is framed through senior-level representatives of the Member States and the Commission. The Commission has indicated its intention to amend Decision 2002/622/EC within six months of the entry into force of this Directive, in order to reflect the new tasks conferred on the RSPG by this Directive. (74) Competent authorities should monitor and secure compliance with the terms and conditions of the general authorisation and rights of use, and in particular to ensure effective and efficient use of radio spectrum and compliance with coverage and quality of service obligations, through administrative penalties including financial penalties and injunctions and withdrawals of rights of use in the event of breaches of those terms and conditions. Undertakings should provide the most accurate and complete information possible to competent authorities to allow them to fulfil their surveillance tasks. (75) The conditions attached to general authorisations and individual rights of use should be limited to those strictly necessary to ensure compliance with requirements and obligations under national law and Union law. (76) Any party subject to a decision of a competent authority should have the right to appeal to a body that is independent of the parties involved and of any external intervention or political pressure which could jeopardise its independent assessment of matters coming before it. That body can be a court. Furthermore, any undertaking which considers that its applications for the granting of rights to install facilities have not been dealt with in accordance with the principles set out in this Directive should be entitled to appeal against such decisions. That appeal procedure should be without prejudice to the division of competences within national judicial systems and to the rights of legal entities or natural persons under national law. In any case, Member States should grant effective judicial review against such decisions. (77) In order to ensure legal certainty for market players, appeal bodies should carry out their functions effectively. In particular, appeal proceedings should not be unduly lengthy. Interim measures suspending the effect of the decision of a competent authority should be granted only in urgent cases in order to prevent serious and irreparable damage to the party applying for those measures and if the balance of interests so requires. (78) There has been a wide divergence in the manner in which appeal bodies have applied interim measures to suspend the decisions of the national regulatory or other competent authorities. In order to achieve greater consistency of approach common standards should be applied in line with the case law of the Court of Justice. Appeal bodies should also be entitled to request available information published by BEREC. Given the importance of appeals for the overall operation of the regulatory framework, a mechanism should be set up, in all the Member States, for collecting information on appeals and decisions to suspend decisions taken by the competent authorities and for the reporting of that information to the Commission and to BEREC. That mechanism should ensure that the Commission or BEREC can retrieve from Member States the text of the decisions and judgments with a view to developing a database. (79) Transparency in the application of the Union mechanism for consolidating the internal market for electronic communications should be increased in the interest of citizens and stakeholders and to enable parties concerned to make their views known, including by way of requiring national regulatory authorities to publish any draft measure at the same time as it is communicated to the Commission, to BEREC, and to the national regulatory authorities in other Member States. Any such draft measure should be reasoned and should contain a detailed analysis. (80) The Commission should be able, after taking utmost account of the opinion of BEREC, to require a national regulatory authority to withdraw a draft measure where it concerns the definition of relevant markets or the designation of undertakings as having significant market power, and where such decisions would create a barrier to the internal market or would be incompatible with Union law and in particular the policy objectives that national regulatory authorities should follow. This procedure is without prejudice to the notification procedure provided for in Directive (EU) 2015/1535 and the Commission\u2019s prerogatives under TFEU in respect of infringements of Union law. (81) The national consultation of interested parties should be conducted prior to the consultation at Union level for the purposes of consolidating the internal market for electronic communications and within the procedure for the consistent application of remedies, in order to allow the views of interested parties to be reflected in the consultation at Union level. This would also avoid the need for a second consultation at Union level in the event of changes to a planned measure as a result of the national consultation. (82) It is important that the regulatory framework is implemented in a timely manner. When the Commission has taken a decision requiring a national regulatory authority to withdraw a planned measure, national regulatory authorities should withdraw its draft measure or submit a revised measure to the Commission. A deadline should be laid down for the notification of the revised measure to the Commission in order to inform market players of the duration of the market review and in order to increase legal certainty. (83) The Union mechanism allowing the Commission to require national regulatory authorities to withdraw planned measures concerning market definition and the designation of undertakings as having significant market power has contributed significantly to a consistent approach in identifying the circumstances in which ex ante regulation may be applied and those in which the undertakings are subject to such regulation. The experience of the procedures under Articles 7 and 7a of Directive 2002/21/EC has shown that inconsistencies in the national regulatory authorities\u2019 application of remedies under similar market conditions undermine the internal market in electronic communications. Therefore, the Commission and BEREC should participate in ensuring, within their respective responsibilities, a higher level of consistency in the application of remedies concerning draft measures proposed by national regulatory authorities. In addition, for draft measures relating to the extension of obligations beyond the first concentration or distribution point, where needed to address high and non-transitory economic or physical barriers to replication, on undertakings irrespective of a designation as having significant market power, or to the regulatory treatment of new very high-capacity network elements where BEREC shares the Commission\u2019s concerns, the Commission should be able to require a national regulatory authority to withdraw a draft measure. In order to benefit from the expertise of national regulatory authorities on the market analysis, the Commission should consult BEREC prior to adoption of its decisions or recommendations. (84) Having regard to the short time-limits in the consultation mechanism at Union level, powers should be conferred on the Commission to adopt recommendations or guidelines to simplify the procedures for exchanging information between the Commission and national regulatory authorities, for example in cases concerning stable markets, or involving only minor changes to previously notified measures. Powers should also be conferred on the Commission in order to allow for the introduction of a notification exemption in order to streamline procedures in certain cases. (85) National regulatory authorities should be required to cooperate with each other, with BEREC and with the Commission, in a transparent manner, to ensure the consistent application, in all Member States, of this Directive. (86) The discretion of national regulatory authorities needs to be reconciled with the development of consistent regulatory practices and the consistent application of the regulatory framework in order to contribute effectively to the development and completion of the internal market. National regulatory authorities should therefore support the internal market activities of the Commission and of BEREC. (87) Measures that could affect trade between Member States are measures that could have an influence, direct or indirect, actual or potential, on the pattern of trade between Member States in a manner which might create a barrier to the internal market. They comprise measures that have a significant impact on undertakings or users in other Member States, which include: measures which affect prices for users in other Member States; measures which affect the ability of an undertaking established in another Member State to provide an electronic communications service, and in particular measures which affect the ability to offer services on a transnational basis; and measures which affect market structure or access, leading to repercussions for undertakings in other Member States. (88) A more convergent use and definition of elements of selection procedures and the conditions attached to the rights of use for radio spectrum which have a significant impact on market conditions and the competitive situation, including conditions for entry and expansion, would be enhanced by a coordination mechanism whereby the RSPG, at the request of the national regulatory or other competent authority or, exceptionally, on its own initiative, convenes a Peer Review Forum to examine draft measures in advance of the granting of rights of use by a given Member State with a view to exchanging best practices. The Peer Review Forum is an instrument of peer learning. It should contribute to a better exchange of best practices between Member States and increase the transparency of the competitive or comparative selection procedures. The Peer Review Process should not be a formal condition of national authorisation procedures. The exchange of views should be based on information provided by the national regulatory or other competent authority that requests the Peer Review Forum and should be a subset of a wider national measure, which may more broadly consist of the granting, trade and lease, duration, renewal or the amendment of rights of use. Therefore, the national regulatory or other competent authority should also be able to provide information on other draft national measures or aspects thereof related to the relevant selection procedure for limiting rights of use for radio spectrum which are not covered by the peer review mechanism. To reduce administrative burden, the national regulatory or other competent authority should be able to submit such information by way of a common reporting format, where available, for transmission to the RSPG members. (89) Where the harmonised assignment of radio spectrum to particular undertakings has been agreed at Union level, Member States should strictly implement such agreements in the granting of rights of use for radio spectrum from the National Frequency Allocation Plan. (90) Member States should be able to consider joint authorisation processes as an option when issuing rights of use where the expected usage covers cross-border situations. (91) Any Commission decision to ensure the harmonised application of this Directive should be limited to regulatory principles, approaches and methodologies. For the avoidance of doubt, it should not prescribe any detail normally required to reflect national circumstances, and it should not prohibit alternative approaches which can reasonably be expected to have equivalent effect. Such a decision should be proportionate and should not have an effect on decisions taken by national regulatory or other competent authorities that do not create a barrier to the internal market. (92) The Union and the Member States have entered into commitments in relation to standards and the regulatory framework of telecommunications networks and services in the World Trade Organization. (93) Standardisation should remain primarily a market-driven process. However there may still be situations where it is appropriate to require compliance with specified standards at Union level in order to improve interoperability, freedom of choice for users and encourage interconnectivity in the internal market. At national level, Member States are subject to Directive (EU) 2015/1535. Standardisation procedures under this Directive are without prejudice to Directives 2014/30/EU (29) and 2014/35/EU (30) of the European Parliament and of the Council, and Directive 2014/53/EU. (94) Providers of public electronic communications networks or publicly available electronic communications services, or of both, should be required to take measures to safeguard the security of their networks and services, respectively, and to prevent or minimise the impact of security incidents. Having regard to the state of the art, those measures should ensure a level of security of networks and services appropriate to the risks posed. Security measures should take into account, as a minimum, all the relevant aspects of the following elements: as regards security of networks and facilities: physical and environmental security, security of supply, access control to networks and integrity of networks; as regards handling of security incidents: handling procedures, security incident detection capability, security incident reporting and communication; as regards business continuity management: service continuity strategy and contingency plans, disaster recovery capabilities; as regards monitoring, auditing and testing: monitoring and logging policies, exercise contingency plans, network and service testing, security assessments and compliance monitoring; and compliance with international standards. (95) Given the growing importance of number-independent interpersonal communications services, it is necessary to ensure that they are also subject to appropriate security requirements in accordance with their specific nature and economic importance. Providers of such services should thus also ensure a level of security appropriate to the risk posed. Given that providers of number-independent interpersonal communications services normally do not exercise actual control over the transmission of signals over networks, the degree of risk for such services can be considered in some respects to be lower than for traditional electronic communications services. Therefore, where justified on the basis of the actual assessment of the security risks involved, the measures taken by providers of number-independent interpersonal communications services should be lighter. The same approach should apply mutatis mutandis to interpersonal communications services which make use of numbers and which do not exercise actual control over signal transmission. (96) Providers of public electronic communications networks or of publicly available electronic communications services should inform users of particular and significant security threats and of measures they can take to protect the security of their communications, for instance by using specific types of software or encryption technologies. The requirement to inform users of such threats should not discharge a service provider from the obligation to take, at its own expense, appropriate and immediate measures to remedy any security threats and restore the normal security level of the service. The provision of such information about security threats to the user should be free of charge. (97) In order to safeguard security of networks and services, and without prejudice to the Member States\u2019 powers to ensure the protection of their essential security interests and public security, and to permit the investigation, detection and prosecution of criminal offences, the use of encryption for example, end-to-end where appropriate, should be promoted and, where necessary, encryption should be mandatory in accordance with the principles of security and privacy by default and by design. (98) Competent authorities should ensure that the integrity and availability of public electronic communications networks are maintained. The European Union Agency for Network and Information Security (\u2018ENISA\u2019) should contribute to an enhanced level of security of electronic communications by, inter alia, providing expertise and advice, and promoting the exchange of best practices. The competent authorities should have the necessary means to perform their duties, including powers to request the information necessary to assess the level of security of networks or services. They should also have the power to request comprehensive and reliable data about actual security incidents that have had a significant impact on the operation of networks or services. They should, where necessary, be assisted by Computer Security Incident Response Teams (\u2018CSIRTs\u2019) established by Directive (EU) 2016/1148 of the European Parliament and of the Council (31). In particular, CSIRTs may be required to provide competent authorities with information about risks and security incidents affecting public electronic communications networks and publicly available electronic communications services, and recommend ways to address them. (99) Where the provision of electronic communications relies on public resources the use of which is subject to specific authorisation, Member States should be able to grant the authority competent for issuance thereof the right to impose fees to ensure optimal use of those resources, in accordance with the procedures envisaged in this Directive. In line with the case-law of the Court of Justice, Member States cannot levy any charges or fees in relation to the provision of networks and electronic communications services other than those provided for by this Directive. In that regard, Member States should have a consistent approach in establishing those charges or fees in order not to provide an undue financial burden linked to the general authorisation procedure or rights of use for providers of electronic communications networks and services. (100) To ensure optimal use of resources, fees should reflect the economic and technical situation of the market concerned as well as any other significant factor determining their value. At the same time, fees should be set in a manner that ensures efficient assignment and use of radio spectrum. This Directive is without prejudice to the purpose for which fees for rights of use and rights to install facilities are employed. It should be possible, for example, to use such fees to finance activities of national regulatory and other competent authorities that cannot be covered by administrative charges. Where, in the case of competitive or comparative selection procedures, fees for rights of use for radio spectrum consist entirely or partly of a one-off amount, payment arrangements should ensure that such fees do not in practice lead to selection on the basis of criteria unrelated to the objective of ensuring optimal use of radio spectrum. The Commission should be able to publish, on a regular basis, benchmark studies and, as appropriate, other guidance with regard to best practices for the assignment of radio spectrum, the assignment of numbering resources or the granting of rights of way. (101) Fees imposed on undertakings for rights of use for radio spectrum can influence decisions about whether to seek such rights and put into use radio spectrum resources. With a view to ensuring optimal use of radio spectrum, Member States should therefore set reserve prices in a way that leads to the efficient assignment of those rights, irrespective of the type of selection procedure used. Member States could also take into account possible costs associated with the fulfilment of authorisation conditions imposed to further policy objectives. In doing so, regard should also be had to the competitive situation of the market concerned including the possible alternative uses of the resources. (102) Optimal use of radio spectrum resources depends on the availability of appropriate networks and associated facilities. In that regard, Member States should aim to ensure that, where national regulatory or other competent authorities apply fees for rights of use for radio spectrum and for rights to install facilities, they take into consideration the need to facilitate continuous infrastructure development with a view to achieving the most efficient use of the resources. Member States should seek to ensure the application, to the best extent possible, of arrangements for the payment of the fees for rights of use for radio spectrum linked with the actual availability of the resource in a manner that supports the investments necessary to promote such infrastructure development and the provision of related services. The payment arrangements should be specified in an objective, transparent, proportionate and non-discriminatory manner before opening procedures for the granting of rights of use for radio spectrum. (103) It should be ensured that procedures exist for the granting of rights to install facilities that are timely, non-discriminatory and transparent, in order to guarantee the conditions for fair and effective competition. This Directive is without prejudice to national provisions governing the expropriation or use of property, the normal exercise of property rights, the normal use of the public domain, or to the principle of neutrality with regard to the rules in Member States governing the system of property ownership. (104) Permits issued to providers of electronic communications networks and services allowing them to gain access to public or private property are essential factors for the establishment of electronic communications networks or new network elements. Unnecessary complexity and delay in the procedures for granting rights of way may therefore represent important obstacles to the development of competition. Consequently, the acquisition of rights of way by authorised undertakings should be simplified. Competent authorities should coordinate the acquisition of rights of way, making relevant information accessible on their websites. (105) It is necessary to strengthen the powers of the Member States as regards holders of rights of way to ensure the entry or roll-out of a new network in a fair, efficient and environmentally responsible way and independently of any obligation on an undertaking designated as having significant market power to grant access to its electronic communications network. Improving facility sharing can lower the environmental cost of deploying electronic communications infrastructure and serve public health, public security and meet town and country planning objectives. Competent authorities should be empowered to require that the undertakings which have benefitted from rights to install facilities on, over or under public or private property share such facilities or property, including physical co-location, after an appropriate period of public consultation, during which all interested parties should be given the opportunity to state their views, in the specific areas where such general interest reasons impose such sharing. That can be the case for instance where the subsoil is highly congested or where a natural barrier needs to be crossed. Competent authorities should in particular be able to impose the sharing of network elements and associated facilities, such as ducts, conduits, masts, manholes, cabinets, antennae, towers and other supporting constructions, buildings or entries into buildings, and a better coordination of civil works on environmental or other public policy grounds. On the contrary, it should be for national regulatory authorities to define rules for apportioning the costs of the facility or property sharing, to ensure that there is an appropriate reward of risk for the undertakings concerned. In light of the obligations imposed by Directive 2014/61/EU, the competent authorities, in particular, local authorities, should also establish appropriate coordination procedures, in cooperation with national regulatory authorities, with respect to public works and other appropriate public facilities or property which should be able to include procedures that ensure that interested parties have information concerning appropriate public facilities or property and ongoing and planned public works, that they are notified in a timely manner of such works, and that sharing is facilitated to the maximum extent possible. (106) Where mobile operators are required to share towers or masts for environmental reasons, such mandated sharing could lead to a reduction in the maximum transmitted power levels allowed for each operator for reasons of public health, and this in turn could require operators to install more transmission sites to ensure national coverage. Competent authorities should seek to reconcile the environmental and public health considerations in question, taking due account of the precautionary approach set out in Council Recommendation 1999/519/EC (32). (107) Radio spectrum is a scarce public resource with an important public and market value. It is an essential input for radio-based electronic communications networks and services and, insofar as it relates to such networks and services, should therefore be efficiently allocated and assigned by national regulatory or other competent authorities in accordance with harmonised objectives and principles governing their action as well as to objective, transparent and non-discriminatory criteria, taking into account the democratic, social, linguistic and cultural interests related to the use of radio spectrum. Decision No 676/2002/EC establishes a framework for harmonisation of radio spectrum. (108) Radio spectrum policy activities in the Union should be without prejudice to measures taken, at Union or national level, in accordance with Union law, to pursue general interest objectives, in particular with regard to public governmental and defence networks, content regulation and audiovisual and media policies, and the right of Member States to organise and use their radio spectrum for public order, public security and defence. (109) Ensuring widespread connectivity in each Member State is essential for economic and social development, participation in public life and social and territorial cohesion. As connectivity and the use of electronic communications become an integral element to European society and welfare, Member States should strive to ensure Union-wide wireless broadband coverage. Such coverage should be achieved by relying on the imposition by Member States of appropriate coverage requirements, which should be adapted to each area served and limited to proportionate burdens in order not to hinder deployment by service providers. Given the major role systems such as radio local area networks (RLANs) play in providing high-speed wireless broadband indoors, measures should aim to ensure the release of sufficient radio spectrum in bands which are particularly valuable assets for the cost-efficient deployment of wireless networks with universal coverage, in particular indoors. Moreover, consistent and coordinated measures for high-quality terrestrial wireless coverage across the Union, building on best national practices for operators\u2019 licence obligations, should aim to meet the radio spectrum policy programme objective that all citizens of the Union should have access both indoors and outdoors, to the fastest broadband speeds of not less than 30 Mbps by 2020, and should aim to achieve an ambitious vision for a gigabit society in the Union. Such measures will promote innovative digital services and ensure long-term socioeconomic benefits. Seamless coverage of the territory as well as connectivity across Member States should be maximised and reliable, with a view to promoting in-border and cross-border services and applications such as connected cars and e-health. (110) The need to ensure that citizens are not exposed to electromagnetic fields at a level harmful to public health is imperative. Member States should pursue consistency across the Union to address this issue, having particular regard to the precautionary approach taken in Recommendation 1999/519/EC, in order to work towards ensuring more consistent deployment conditions. Member States should apply the procedure set out in Directive (EU) 2015/1535, where relevant, with a view also to providing transparency to stakeholders and to allow other Member States and the Commission to react. (111) Radio spectrum harmonisation and coordination, and equipment regulation supported by standardisation, are complementary and need to be coordinated closely to meet their joint objectives effectively, with the support of the RSPG. Coordination between the content and timing of mandates to CEPT under Decision No 676/2002/EC and standardisation requests to standardisation bodies, such as the European Telecommunications Standards Institute, including with regard to radio receivers parameters, should facilitate the introduction of future systems, support radio spectrum sharing opportunities and ensure efficient radio spectrum management. (112) The demand for harmonised radio spectrum is not uniform in all parts of the Union. Where there is lack of demand for all or part of a harmonised band at regional or national level, Member States could, by way of exception, allow an alternative use of the band, for example to cover lack of market supply for certain uses, for as long as such lack of demand persists and provided that the alternative use does not prejudice the harmonised use of the band by other Member States and that it ceases when demand for the harmonised use materialises. (113) Flexibility in radio spectrum management and access to radio spectrum has been established through technology and service-neutral authorisations to allow radio spectrum users to choose the best technologies and services to apply in radio spectrum bands declared available for electronic communications services in the relevant National Frequency Allocation Plans in accordance with Union law (\u2018the principle of technology neutrality and the principle of service neutrality\u2019). The administrative determination of technologies and services should apply only when general interest objectives are at stake and should be clearly justified and subject to regular review. (114) Restrictions to the principle of technology neutrality should be appropriate and justified by the need to avoid harmful interference, for example by imposing emission masks and power levels, to ensure the protection of public health by limiting public exposure to electromagnetic fields, to ensure the proper functioning of services through an adequate level of technical quality of service, while not necessarily precluding the possibility of using more than one service in the same radio spectrum band, to ensure proper sharing of radio spectrum, in particular where its use is subject only to general authorisations, to safeguard efficient use of radio spectrum, or to fulfil a general interest objective in accordance with Union law. (115) Radio spectrum users should also be able to choose freely the services they wish to offer over the radio spectrum. On the other hand, measures should be allowed which require the provision of a specific service to meet clearly defined general interest objectives such as safety of life, the need to promote social, regional and territorial cohesion, or the avoidance of the inefficient use of radio spectrum to be permitted where necessary and proportionate. Those objectives should include the promotion of cultural and linguistic diversity and media pluralism, as defined by Member States in accordance with Union law. Except where necessary to protect safety of life or, by way of exception, to fulfil other general interest objectives as defined by Member States in accordance with Union law, exceptions should not result in certain services having exclusive use, but should rather grant them priority so that, insofar as possible, other services or technologies could coexist in the same radio spectrum band. It lies within the competence of the Member States to define the scope and nature of any exception regarding the promotion of cultural and linguistic diversity and media pluralism. (116) As the allocation of radio spectrum to specific technologies or services is an exception to the principles of technology and service neutrality and reduces the freedom to choose the service provided or technology used, any proposal for such allocation should be transparent and subject to public consultation. (117) Where Member States decide, by way of exception, to limit the freedom to provide electronic communications networks and services based on grounds of public policy, public security or public health, Member States should explain the reasons for such a limitation. (118) Radio spectrum should be managed in a manner that ensures the avoidance of harmful interference. The basic concept of harmful interference should therefore be properly defined to ensure that regulatory intervention is limited to the extent necessary to prevent such interference, having regard also to the need to take into consideration advanced methods for protection against harmful interference, with the aim of applying those technologies and radio spectrum management methods in order to avoid, to the extent possible, the application of the non-interference and non-protection principle. Transport has a strong cross-border element and its digitalisation brings challenges. Vehicles (such as metro, bus, cars, trucks, trains,) are becoming increasingly autonomous and connected. In the internal market, vehicles travel beyond national borders more easily. Reliable communications, and avoiding harmful interference, are critical for the safe and good operation of vehicles and their on-board communications systems. (119) With growing radio spectrum demand and new varying applications and technologies which necessitate more flexible access and use of radio spectrum, Member States should promote the shared use of radio spectrum by determining the most appropriate authorisation regimes for each scenario and by establishing appropriate and transparent rules and conditions therefor. Shared use of radio spectrum increasingly ensures its effective and efficient use by allowing several independent users or devices to access the same radio spectrum band under various types of legal regimes in order to make additional radio spectrum resources available, raise usage efficiency and facilitate radio spectrum access for new users. Shared use can be based on general authorisations or licence-exempt use allowing, under specific sharing conditions, several users to access and use the same radio spectrum in different geographic areas or at different moments in time. It can also be based on individual rights of use under arrangements such as licensed shared access where all users (with an existing user and new users) agree on the terms and conditions for shared access, under the supervision of the competent authorities, in such a way as to ensure a minimum guaranteed radio transmission quality. When allowing shared use under different authorisation regimes, Member States should not set widely diverging durations for such use under different authorisation regimes. (120) General authorisations for the use of radio spectrum may facilitate the most effective use of radio spectrum and foster innovation in some cases and are pro-competitive, whereas individual rights of use for radio spectrum in other cases may be the most appropriate authorisation regime in the presence of certain specific circumstances. Individual rights of use should be considered, for example, when favourable propagation characteristics of the radio spectrum or the envisaged power level of the transmission imply that general authorisations cannot address the interference concerns in light of the required quality of service. Technical measures such as solutions to improve receiver resilience might enable the use of general authorisations or radio spectrum sharing, and possibly avoid systematic recourse to the non-interference and non-protection principle. (121) In order to ensure predictability and preserve legal certainty and investment stability, Member States should establish, in advance, appropriate criteria to determine compliance with the objective of efficient use of radio spectrum by the holders of the rights when implementing the conditions attached to individual rights of use and general authorisations. Interested parties should be involved in the definition of such conditions and informed, in a transparent manner, about how the fulfilment of their obligations will be assessed. (122) In order to avoid the creation of barriers to market entry, namely through anti-competitive hoarding, enforcement of conditions attached to radio spectrum rights by Member States should be effective and all competent authorities should participate where necessary. Enforcement conditions should include the application of a \u2018use it or lose it\u2019 clause. In order to ensure legal certainty in respect of the possible exposure to any penalty for failure to use radio spectrum, thresholds of use, including in terms of time, quantity or identity of radio spectrum, should be established in advance. Trading and leasing of radio spectrum should ensure the effective use by the original holder of the right. (123) Where harmonised conditions for a radio spectrum band are established under Decision No 676/2002/EC, competent authorities are to decide on the most appropriate authorisation regime to be applied in that band or parts thereof. Where all Member States are likely to face similar problems for which diverging solutions could fragment the internal market in equipment, and thereby delay the rollout of 5G systems, it may be necessary for the Commission, taking utmost account of the opinion of the RSPG, to recommend common solutions, acknowledging technical harmonisation measures in force. This could provide a common toolbox for Member States which they could take into account when identifying appropriate consistent authorisation regimes to be applied to a band, or part of a band, depending on factors such as population density, propagation characteristics of the bands, divergence between urban and rural uses, the possible need to protect existing services and the resulting implications for economies of scale in manufacturing. (124) Network infrastructure sharing, and in some instances radio spectrum sharing, can allow for a more effective and efficient use of radio spectrum and ensure the rapid deployment of networks, especially in less densely populated areas. When establishing the conditions to be attached to rights of use for radio spectrum, competent authorities should also consider authorising forms of sharing or coordination between undertakings with a view to ensuring effective and efficient use of radio spectrum or compliance with coverage obligations, in accordance with competition law principles. (125) The requirement to respect the principles of technology and service neutrality in granting rights of use, together with the possibility to transfer rights between undertakings, underpin the freedom and means to deliver electronic communications services to the public, thereby also facilitating the achievement of general interest objectives. This Directive is without prejudice whether radio spectrum is assigned directly to providers of electronic communications networks or services or to entities that use those networks or services. Such entities may be radio or television broadcast content providers. The responsibility for compliance with the conditions attached to the right of use for radio spectrum and the relevant conditions attached to the general authorisation should in any case lie with the undertaking to which the right of use for radio spectrum has been granted. Certain obligations imposed on broadcasters for the delivery of audiovisual media services may require the use of specific criteria and procedures for the granting of radio spectrum usage rights to meet a specific general interest objective set out by Member States in accordance with Union law. However, the procedure for the granting of such right should in any event be objective, transparent, non-discriminatory and proportionate. (126) The case-law of the Court of Justice requires that any national restrictions to the rights guaranteed by Article 56 TFEU should be objectively justified and proportionate and should not exceed those necessary to achieve their objectives. Moreover, radio spectrum granted without following an open procedure should not be used for purposes other than the general interest objective for which they were granted. In such a case, the interested parties should be given the opportunity to comment within a reasonable period. As part of the application procedure for granting rights, Member States should verify whether the applicant is able to comply with the conditions to be attached to such rights. Those conditions should be reflected in eligibility criteria set out in objective, transparent, proportionate and non-discriminatory terms prior to the launch of any competitive selection procedure. For the purpose of applying such criteria, the applicant may be requested to submit the necessary information to prove his ability to comply with those conditions. Where such information is not provided, the application for the right of use for radio spectrum may be rejected. (127) Member States should, prior to the granting of the right, impose only the verification of elements that can reasonably be demonstrated by an applicant exercising ordinary care, taking due account of the important public and market value of radio spectrum as a scarce public resource. This is without prejudice to the possibility for subsequent verification of the fulfilment of eligibility criteria, for example through milestones, where criteria could not reasonably be met initially. To preserve effective and efficient use of radio spectrum, Member States should not grant rights where their review indicates applicants' inability to comply with the conditions, without prejudice to the possibility of facilitating time-limited experimental use. Sufficiently long duration of authorisations for the use of radio spectrum should increase investment predictability to contribute to faster network roll-out and better services, as well as stability to support radio spectrum trading and leasing. Unless use of radio spectrum is authorised for an unlimited period, such a duration should both take account of the objectives pursued and be sufficient to facilitate recoupment of the investments made. While a longer duration can ensure investment predictability, measures to ensure effective and efficient use of radio spectrum, such as the power of the competent authority to amend or withdraw the right in the case of non-compliance with the conditions attached to the rights of use, or the facilitation of radio spectrum tradability and leasing, will serve to prevent inappropriate accumulation of radio spectrum and support greater flexibility in distributing radio spectrum resources. Greater recourse to annualised fees is also a means to ensure a continuous assessment of the use of the radio spectrum by the holder of the right. (128) Considering the importance of technical innovation, Member States should be able to provide for rights to use radio spectrum for experimental purposes, subject to specific restrictions and conditions strictly justified by the experimental nature of such rights. (129) In deciding whether to renew already granted rights of use for harmonised radio spectrum, competent authorities should take into account the extent to which renewal would further the objectives of the regulatory framework and other objectives under Union and national law. Any such decision should be subject to an open, non-discriminatory and transparent procedure and based on a review of how the conditions attached to the rights concerned have been fulfilled. When assessing the need to renew rights of use, Member States should weigh the competitive impact of renewing assigned rights against the promotion of more efficient exploitation or of innovative new uses that might result if the band were opened to new users. Competent authorities should be able to make their determination in this regard by allowing for only a limited duration for renewal in order to prevent severe disruption of established use. While decisions on whether to renew rights assigned prior to the applicability of this Directive should respect any rules already applicable, Member States should also ensure that they do not prejudice the objectives of this Directive. (130) When renewing existing rights of use for harmonised radio spectrum, Member States should, together with the assessment of the need to renew the right, review the fees attached thereto with a view to ensuring that those fees continue to promote optimal use, taking account, inter alia, of market developments and technological evolution. For reasons of legal certainty, it is appropriate for any adjustments to the existing fees to be based on the same principles as those applicable to the award of new rights of use. (131) Effective management of radio spectrum can be ensured by facilitating the continued efficient use of radio spectrum that has already been assigned. In order to ensure legal certainty to holders of the rights, the possibility of renewal of rights of use should be considered within an appropriate time-span prior to the expiry of the rights concerned, for example, where rights have been assigned for 15 years or more, at least two years before expiry of those rights, unless the possibility of renewal was explicitly excluded at the time of assignment of the rights. In the interest of continuous resource management, competent authorities should be able to undertake such consideration at their own initiative as well as in response to a request from the assignee. The renewal of the right to use should not be granted contrary to the will of the assignee. (132) Transfer of rights of use for radio spectrum can be an effective means of increasing the efficient use of spectrum. For the sake of flexibility and efficiency, and to allow valuation of radio spectrum by the market, Member States should by default allow radio spectrum users to transfer or lease their rights of use for radio spectrum to third parties following a simple procedure and subject to the conditions attached to such rights and to competition rules, under the supervision of the national regulatory authorities responsible. In order to facilitate such transfers or leases, provided that technical implementing measures adopted under Decision No 676/2002/EC are respected, Member States should also consider requests to have radio spectrum rights partitioned or disaggregated and conditions for use reviewed. (133) Measures taken specifically to promote competition when granting or renewing rights of use for radio spectrum should be decided by national regulatory and other competent authorities, which have the necessary economic, technical and market knowledge. Radio spectrum assignment conditions can influence the competitive situation in electronic communications markets and conditions for entry. Limited access to radio spectrum, in particular when radio spectrum is scarce, can create a barrier to entry or hamper investment, network roll-out, the provision of new services or applications, innovation and competition. New rights of use, including those acquired through transfer or leasing, and the introduction of new flexible criteria for radio spectrum use can also influence existing competition. Where unduly applied, certain conditions used to promote competition, can have other effects; for example, radio spectrum caps and reservations can create artificial scarcity, wholesale access obligations can unduly constrain business models in the absence of market power, and limits on transfers can impede the development of secondary markets. Therefore, a consistent and objective competition test for the imposition of such conditions is necessary and should be applied consistently. The use of such measures should therefore be based on a thorough and objective assessment, by national regulatory and other competent authorities, of the market and the competitive conditions thereof. National competent authorities should, however, always ensure the effective and efficient use of radio spectrum and avoid distortion of competition through anti-competitive hoarding. (134) Building on opinions from the RSPG, the adoption of a common deadline for allowing the use of a radio spectrum band which has been harmonised under Decision No 676/2002/EC can be necessary to avoid cross-border interference and beneficial to ensure release of the full benefits of the related technical harmonisation measures for equipment markets and for the deployment of very high capacity networks and services. Allowing the use of a radio spectrum band entails assigning radio spectrum under a general authorisation regime or individual rights of use in order to permit the use of radio spectrum as soon as the assignment process is completed. In order to assign radio spectrum bands, it might be necessary to release a band occupied by other users and to compensate them. Implementation of a common deadline for allowing the use of harmonised bands for electronic communications services, including for 5G, might however be affected in a particular Member State by problems relating to unresolved cross-border coordination issues between Member States or with third countries, to the complexity of ensuring the technical migration of existing users of a band; a restriction to the use of the band based on a general interest objective, to the safeguarding of national security and defence or to force majeure. In any case, Member States should take all measures to reduce any delay to the minimum in terms of geographical coverage, timing and radio spectrum range. Moreover, Member States should be able, where appropriate in light of their assessment of the relevant circumstances, to request the Union to provide legal, political and technical support to resolve radio spectrum coordination issues with countries neighbouring the Union, including candidate and acceding countries, in such a way that the Member States concerned can observe their obligations under Union law. (135) In order to ensure increased coordinated availabilities of radio spectrum by 2020 to achieve very high speed fixed and wireless networks in the context of 5G, the 3,4-3,8 GHz and the 24,25-27,5 GHz bands have been identified by the RSPG as priority bands suitable to fulfil the objectives of the 5G Action Plan by 2020. The 40,5-43,5 GHz and 66-71 GHz bands have also been identified for further study. It is therefore necessary to ensure that, by 31 December 2020, the 3,4-3,8 GHz and the 24,25-27,5 GHz bands or parts thereof are available for terrestrial systems capable of providing wireless broadband services under harmonised conditions established by technical implementing measures adopted in accordance with Article 4 of Decision No 676/2002/EC, complementing Decision (EU) 2017/899 of the European Parliament and of the Council (33), as those bands have specific qualities, in terms of coverage and data capacity, which allow them to be combined appropriately to meet 5G requirements. Member States could, however, be affected by interference likely to arise from third countries which, in accordance with the ITU Radio Regulations, have identified those bands for services other than international mobile telecommunications. This might have an effect on the obligation to meet a common implementation date. Future use of the 26 GHz band for 5G terrestrial wireless services is likely, inter alia, to target urban areas and sub-urban hotspot areas, while some deployment can be foreseen along major roads and railway tracks in rural areas. This provides the opportunity to use the 26 GHz band for services other than 5G wireless outside those geographic areas, for example, for business specific communications or indoor use, and therefore allows Member States to designate and make that band available on a non-exclusive basis. (136) Where demand for a radio spectrum band exceeds the availability and, as a result, a Member State concludes that the rights of use for radio spectrum is to be limited, appropriate and transparent procedures should apply for the granting of such rights to avoid any discrimination and optimise the use of the scarce resource. Such limitation should be justified, proportionate and based on a thorough assessment of market conditions, giving due weight to the overall benefits for users and to national and internal market objectives. The objectives governing any limitation procedure should be clearly established in advance. When considering the most appropriate selection procedure, and in accordance with coordination measures taken at Union level, Member States should, in a timely and transparent manner, consult all interested parties on the justification, objectives and conditions of the procedure. Member States should be able to use, inter alia, competitive or comparative selection procedures for the assignment of radio spectrum or of numbering resources with exceptional economic value. In administering such schemes, competent authorities should take into account the objectives of this Directive. If a Member State finds that further rights can be made available in a band, it should start the process therefor. (137) Massive growth in radio spectrum demand, and in end-user demand for wireless broadband capacity, calls for solutions allowing alternative, complementary, spectrally efficient access solutions, including low-power wireless access systems with a small-area operating range, such as RLANs and networks of low-power small-size cellular access points. Such complementary wireless access systems, in particular publicly accessible RLAN access points, increase access to the internet for end-users and mobile traffic off-loading for mobile operators. RLANs use harmonised radio spectrum without requiring an individual authorisation or a right of use for radio spectrum. To date, most RLAN access points are used by private users as local wireless extension of their fixed broadband connection. End-users, within the limits of their own internet subscription, should not be prevented from sharing access to their RLAN with others, in order to increase the number of available access points, in particular, in densely populated areas, maximise wireless data capacity through radio spectrum re-use and create a cost-effective complementary wireless broadband infrastructure accessible to other end-users. Therefore, unnecessary restrictions to the deployment and interlinkage of RLAN access points should also be removed. (138) Public authorities or public service providers that use RLANs in their premises for their personnel, visitors or clients, for example to facilitate access to e-Government services or for information on public transport or road traffic management, could also provide access to such access points for general use by citizens as an ancillary service to services they offer to the public on such premises, to the extent allowed by competition and public procurement rules. Moreover, the provider of such local access to electronic communications networks within or around a private property or a limited public area on a non-commercial basis or as an ancillary service to another activity that is not dependent on such access, such as RLAN hotspots made available to customers of other commercial activities or to the general public in that area, can be subject to compliance with general authorisations for rights of use for radio spectrum but should not be subject to any conditions or requirements attached to general authorisations applicable to providers of public electronic communications networks or services or to obligations regarding end-users or interconnection. However, such a provider should remain subject to the liability rules set out in Directive 2000/31/EC of the European Parliament and of the Council (34). Further technologies, such as LiFi, are emerging and will complement current radio spectrum capabilities of RLANs and wireless access point to include optical visible light-based access points and lead to hybrid local area networks allowing optical wireless communication. (139) Since low power small-area wireless access points, such as femtocells, picocells, metrocells or microcells, can be very small and make use of unobtrusive equipment similar to that of domestic RLAN routers, which do not require any permits beyond those necessary for the use of radio spectrum, and considering the positive impact of such access points on the use of radio spectrum and on the development of wireless communications, any restriction to their deployment should be limited to the greatest extent possible. As a result, in order to facilitate the deployment of small-area wireless access points, and without prejudice to any applicable requirement related to radio spectrum management, Member States should not subject to any individual permits the deployment of such devices on buildings which are not officially protected as part of a designated environment or because of their special architectural or historical merit, except for reasons of public safety. To that end, their characteristics, such as maximum size, weight and emission characteristics, should be specified at Union level in a proportionate way for local deployment and to ensure a high level of protection of public health, as laid down in Recommendation 1999/519/EC. For the operation of small-area wireless access points, Article 7 of Directive 2014/53/EU should apply. This is without prejudice to private property rights set out in Union or national law. The procedure for considering permit applications should be streamlined and without prejudice to any commercial agreements and any administrative charge involved should be limited to the administrative costs relating to the processing of the application. The process of assessing a request for a permit should take as little time as possible, and in principle no longer than four months. (140) Public buildings and other public infrastructure are visited and used daily by a significant number of end-users who need connectivity to consume eGovernment, eTransport and other services. Other public infrastructure, such as street lamps, traffic lights, offer very valuable sites for deploying small cells, for instance, due to their density. Without prejudice to the possibility for competent authorities to subject the deployment of small-area wireless access points to individual prior permits, operators should have the right to access to those public sites for the purpose of adequately serving demand. Member States should therefore ensure that such public buildings and other public infrastructure are made available on reasonable conditions for the deployment of small-cells with a view to complementing Directive 2014/61/EU and without prejudice to the principles set out in this Directive. Directive 2014/61/EU follows a functional approach and imposes obligations of access to physical infrastructure only when it is part of a network and only if it is owned or used by a network operator, thereby leaving many buildings owned or used by public authorities outside its scope. On the contrary, a specific obligation is not necessary for physical infrastructure, such as ducts or poles, used for intelligent transport systems, which are owned by network operators (providers of transport services or providers of public electronic communications networks), and host parts of a network, thus falling within the scope of Directive 2014/61/EU. (141) The provisions of this Directive as regards access and interconnection apply to public electronic communications networks. Providers of electronic communications networks other than to the public do not have access or interconnection obligations under this Directive except where, in benefiting from access to public networks, they may be subject to conditions laid down by Member States. (142) The term \u2018access\u2019 has a wide range of meanings, and it is therefore necessary to define precisely how that term is used in this Directive, without prejudice to how it is used in other Union measures. An operator may own the underlying network or facilities or may rent some or all of them. (143) In an open and competitive market, there should be no restrictions that prevent undertakings from negotiating access and interconnection arrangements between themselves, in particular on cross-border agreements, subject to the competition rules laid down in the TFEU. In the context of achieving a more efficient, truly pan-European market, with effective competition, more choice and competitive services to end-users, undertakings which receive requests for access or interconnection from other undertakings that are subject to general authorisation in order to provide electronic communications networks or services to the public should in principle conclude such agreements on a commercial basis, and negotiate in good faith. (144) In markets where there continue to be large differences in negotiating power between undertakings, and where some undertakings rely on infrastructure provided by others for delivery of their services, it is appropriate to establish a regulatory framework to ensure that the market functions effectively. National regulatory authorities should have the power to secure, where commercial negotiation fails, adequate access and interconnection and interoperability of services in the interest of end-users. In particular, they can ensure end-to-end connectivity by imposing proportionate obligations on undertakings that are subject to the general authorisation and that control access to end-users. Control of means of access may entail ownership or control of the physical link to the end-user (either fixed or mobile), or the ability to change or withdraw the national number or numbers needed to access an end-user\u2019s network termination point. This would be the case for example if network operators were to restrict unreasonably end-user choice for access to internet portals and services. (145) In light of the principle of non-discrimination, national regulatory authorities should ensure that all undertakings, irrespective of their size and business model, whether vertically integrated or separated, can interconnect on reasonable terms and conditions, with a view to providing end-to-end connectivity and access to the internet. (146) National legal or administrative measures that link the terms and conditions for access or interconnection to the activities of the party seeking interconnection, and specifically to the degree of its investment in network infrastructure, and not to the interconnection or access services provided, may cause market distortion and may therefore not be compatible with competition rules. (147) Network operators who control access to their own customers do so on the basis of unique numbers or addresses from a published numbering or addressing range. Other network operators need to be able to deliver traffic to those customers, and so need to be able to interconnect directly or indirectly to each other. It is therefore appropriate to lay down rights and obligations to negotiate interconnection. (148) Interoperability is of benefit to end-users and is an important aim of that regulatory framework. Encouraging interoperability is one of the objectives for national regulatory and other competent authorities as set out in that framework. That framework also provides for the Commission to publish a list of standards or specifications covering the provision of services, technical interfaces or network functions, as the basis for encouraging harmonisation in electronic communications. Member States should encourage the use of published standards or specifications to the extent strictly necessary to ensure interoperability of services and to improve freedom of choice for users. (149) Currently both end-to-end connectivity and access to emergency services depend on end-users using number-based interpersonal communications services. Future technological developments or an increased use of number-independent interpersonal communications services could entail a lack of sufficient interoperability between communications services. As a consequence, significant barriers to market entry and obstacles to further onward innovation could emerge and appreciably threaten effective end-to-end connectivity between end-users. (150) Where such interoperability issues arise, the Commission should be able to request a BEREC report which should provide a factual assessment of the market situation at Union and Member State level. Taking utmost account of the BEREC report and other available evidence and taking into account the effects on the internal market, the Commission should decide whether there is a need for regulatory intervention by national regulatory or other competent authorities. If the Commission considers that such regulatory intervention should be considered by national regulatory or other competent authorities, it should be able to adopt implementing measures specifying the nature and scope of possible regulatory interventions by national regulatory or other competent authorities, including in particular obligations to publish and allow the use, modification and redistribution of relevant information by the authorities and other providers and measures to impose the mandatory use of standards or specifications on all or specific providers. (151) National regulatory or other competent authorities should assess, in light of the specific national circumstances, whether any intervention is necessary and justified to ensure end-to-end-connectivity, and if so, impose proportionate obligations, in accordance with the Commission\u2019s implementing measures, on those providers of number-independent interpersonal communications services with a significant level of coverage and user-uptake. The term significant should be interpreted in the sense that the geographic coverage and the number of end-users of the provider concerned represent a critical mass with a view to achieving the goal of ensuring end-to-end connectivity between end-users. Providers with a limited number of end-users or limited geographic coverage which would contribute only marginally to achieving that goal, should normally not be subject to such interoperability obligations. (152) In situations where undertakings are deprived of access to viable alternatives to non-replicable wiring, cables and associated facilities inside buildings or up to the first concentration or distribution point and in order to promote competitive outcomes in the interest of end-users, national regulatory authorities should be empowered to impose access obligations on all undertakings, irrespective of a designation as having significant market power. In that regard, national regulatory authorities should take into consideration all technical and economic barriers to future replication of networks. However, as such obligations can in certain cases be intrusive, can undermine incentives for investments, and can have the effect of strengthening the position of dominant players, they should be imposed only where justified and proportionate to achieving sustainable competition in the relevant markets. The mere fact that more than one such infrastructure already exists should not necessarily be interpreted as showing that its assets are replicable. If necessary in combination with such access obligations, undertakings should also be able to rely on the obligations to provide access to physical infrastructure on the basis of Directive 2014/61/EU. Any obligations imposed by the national regulatory authority under this Directive and decisions taken by other competent authorities under Directive 2014/61/EU to ensure access to in-building physical infrastructure or to physical infrastructure up to the access point should be consistent. (153) National regulatory authorities should be able, to the extent necessary, to impose obligations on undertakings to provide access to the facilities referred to in an annex to this Directive, namely application programming interfaces (APIs) and electronic programme guides (EPGs), to ensure not only accessibility for end-users to digital radio and television broadcast services but also to related complementary services. Such complementary services should be able to include programme related services which are specifically designed to improve accessibility for end-users with disabilities, and programme related connected television services. (154) It is important that when national regulatory authorities assess the concentration or distribution point up to which they intend to impose access, they choose a point in accordance with BEREC guidelines. Selecting a point nearer to end-users will be more beneficial to infrastructure competition and the roll-out of very high capacity networks. In this way the national regulatory authority should first consider choosing a point in a building or just outside a building. It could be justified to extend access obligations to wiring and cables beyond the first concentration or distribution point while confining such obligations to points as close as possible to end-users capable of hosting a sufficient number of end-users, where it is demonstrated that replication faces high and non-transitory physical or economic barriers, leading to important competition problems or market failures at the retail level to the detriment of end-users. The assessment of the replicability of network elements requires a market review which is different from an analysis assessing significant market power, and so the national regulatory authority does not need to establish significant market power in order to impose these obligations. On the other hand, such review requires a sufficient economic assessment of market conditions, to establish whether the criteria necessary to impose obligations beyond the first concentration or distribution point are met. Such extended access obligations are more likely to be necessary in geographical areas where the business case for alternative infrastructure rollout is more risky, for example because of low population density or because of the limited number of multi-dwelling buildings. Conversely, a high concentration of households might indicate that the imposition of such obligations is unnecessary. National regulatory authorities should also consider whether such obligations have the potential to strengthen the position of undertakings designated as having significant market power. National regulatory authorities should be able to impose access to active or virtual network elements used for service provision on such infrastructure if access to passive elements would be economically inefficient or physically impracticable, and if the national regulatory authority considers that, absent such an intervention, the purpose of the access obligation would be circumvented. In order to enhance consistent regulatory practice across the Union, the Commission should be able to require the national regulatory authority to withdraw its draft measures extending access obligations beyond the first concentration or distribution point, where BEREC shares the Commission\u2019s serious doubts as to the compatibility of the draft measure with Union law and in particular the regulatory objectives of this Directive. (155) In such cases, in order to comply with the principle of proportionality, it can be appropriate for national regulatory authorities to exempt certain categories of owners or undertakings, or both, from obligations going beyond the first concentration or distribution point, which should be determined by national regulatory authorities, on the grounds that an access obligation not based on an undertaking\u2019s designation as having significant market power would risk compromising their business case for recently deployed network elements, in particular by small local projects. Wholesale-only undertakings should not be subject to such access obligations if they offer an effective alternative access on a commercial basis to a very high capacity network, on fair, non-discriminatory and reasonable terms and conditions, including as regards price. It should be possible to extend that exemption to other providers on the same terms. The exemption may not be appropriate for providers that are in receipt of public funding. (156) Sharing of passive infrastructure used in the provision of wireless electronic communications services in compliance with competition law principles can be particularly useful to maximise very high capacity connectivity throughout the Union, especially in less dense areas where replication is impracticable and end-users risk being deprived of such connectivity. National regulatory or other competent authorities should, by way of exception, be able to impose such sharing or localised roaming access, in accordance with Union law, if that possibility has been clearly established in the original conditions for the granting of the right of use and they demonstrate the benefits of such sharing in terms of overcoming insurmountable economic or physical obstacles and access to networks or services is therefore severely deficient or absent, and taking into account several factors, including in particular the need for coverage along major transport paths, choice and a higher quality of service for end-users as well as the need to maintain infrastructure roll-out incentives. In circumstances where there is no access by end-users, and sharing of passive infrastructure alone does not suffice to address the situation, the national regulatory authorities should be able to impose obligations on the sharing of active infrastructure. In so doing, national regulatory or other competent authorities retain the flexibility to choose the most appropriate sharing or access obligation which should be proportionate and justified based on the nature of the problem identified. (157) While it is appropriate in some circumstances for a national regulatory or other competent authority to impose obligations on undertakings irrespective of a designation of significant market power in order to achieve goals such as end-to-end connectivity or interoperability of services, it is necessary to ensure that such obligations are imposed in accordance with the regulatory framework and, in particular, its notification procedures. Such obligations should be imposed only where justified in order to secure the objectives of this Directive, and where they are objectively justified, transparent, proportionate and non-discriminatory for the purpose of promoting efficiency, sustainable competition, efficient investment and innovation, and giving the maximum benefit to end-users, and imposed in accordance with the relevant notification procedures. (158) In order to overcome insurmountable economic or physical obstacles for providing end-users with services or networks which rely on the use of radio spectrum and where mobile coverage gaps persist, their closing may require the access and sharing of passive infrastructure, or, where this is not sufficient, the sharing of active infrastructure, or localised roaming access agreements. Without prejudice to sharing obligations attached to the rights of use on the basis of other provisions of this Directive, and in particular measures to promote competition, where national regulatory or other competent authorities intend to take measures to impose the sharing of passive infrastructure, or when passive access and sharing are not sufficient, active infrastructure sharing or localised roaming access agreements, they may, however, also be called to consider the possible risk for market participants in underserved areas. (159) Competition rules alone may not always be sufficient to ensure cultural diversity and media pluralism in the area of digital television. Technological and market developments make it necessary to review obligations to provide conditional access on fair, reasonable and non-discriminatory terms on a regular basis, by a Member State for its national market, in particular to determine whether it is justified to extend obligations to EPGs and APIs, to the extent necessary to ensure accessibility for end-users to specified digital broadcasting services. Member States should be able to specify the digital broadcasting services to which access by end-users is to be ensured by any legislative, regulatory or administrative means that they consider to be necessary. (160) Member States should also be able to permit their national regulatory authority to review obligations in relation to conditional access to digital broadcasting services in order to assess through a market analysis whether to withdraw or amend conditions for undertakings that do not have significant market power on the relevant market. Such a withdrawal or amendment should not adversely affect access for end-users to such services or the prospects for effective competition. (161) There is a need for ex ante obligations in certain circumstances in order to ensure the development of a competitive market, the conditions of which favour the deployment and take-up of very high capacity networks and services, and the maximisation of end-user benefits. The definition of significant market power used in this Directive is equivalent to the concept of dominance as defined in the case-law of the Court of Justice. (162) Two or more undertakings can be found to enjoy a joint dominant position not only where there exist structural or other links between them but also where the structure of the relevant market is conducive to coordinated effects, that is, it encourages parallel or aligned anti-competitive behaviour on the market. (163) It is essential that ex ante regulatory obligations should be imposed on a wholesale market only where there are one or more undertakings with significant market power, with a view to ensuring sustainable competition and where Union and national competition law remedies are not sufficient to address the problem. The Commission has drawn up guidelines at Union level in accordance with the principles of competition law for national regulatory authorities to follow in assessing whether competition is effective in a given market and in assessing significant market power. National regulatory authorities should analyse whether a given product or service market is effectively competitive in a given geographical area, which could be the whole or a part of the territory of the Member State concerned or neighbouring parts of territories of Member States considered together. An analysis of effective competition should include an analysis as to whether the market is prospectively competitive, and thus whether any lack of effective competition is durable. Those guidelines should also address the issue of newly emerging markets, where de facto the market leader is likely to have a substantial market share but should not be subjected to inappropriate obligations. The Commission should review the guidelines regularly, in particular on the occasion of a review of the existing law, taking into account the case-law of the Court of Justice, economic thinking and actual market experience and with a view to ensuring that they remain appropriate in a rapidly developing market. National regulatory authorities will need to cooperate with each other where the relevant market is found to be transnational. (164) In determining whether an undertaking has significant market power in a specific market, national regulatory authorities should act in accordance with Union law and take utmost account of the Commission guidelines on market analysis and the assessment of significant market power. (165) National regulatory authorities should define relevant geographic markets within their territory taking into utmost account the Commission Recommendation on relevant product and service markets (the \u2018Recommendation\u2019) adopted pursuant to this Directive and taking into account national and local circumstances. Therefore, national regulatory authorities should at least analyse the markets that are contained in the Recommendation, including those markets that are listed but no longer regulated in the specific national or local context. National regulatory authorities should also analyse markets that are not contained in that Recommendation, but that are regulated within the territory of their jurisdiction on the basis of previous market analyses, or other markets, if they have sufficient grounds to consider that the three criteria provided in this Directive are met. (166) Transnational markets can be defined when it is justified by the geographic market definition, taking into account all supply-side and demand-side factors in accordance with competition law principles. BEREC is the most appropriate body to undertake such analysis, benefiting from the extensive collective experience of national regulatory authorities when defining markets on a national level. National circumstances should be taken into account when an analysis of potential transnational markets is undertaken. If transnational markets are defined and warrant regulatory intervention, concerned national regulatory authorities should cooperate to identify the appropriate regulatory response, including in the process of notification to the Commission. They can also cooperate in the same manner where transnational markets are not identified but on their territories market conditions are sufficiently homogeneous to benefit from a coordinated regulatory approach, such as for example in terms of similar costs, market structures or operators, or in the case of transnational or comparable end-user demand. (167) In some circumstances geographic markets are defined as national or sub-national, for example due to the national or local nature of network roll-out which determines the boundaries of undertakings\u2019 potential market power in respect of wholesale supply, but there is still a significant transnational demand from one or more categories of end-users. That can in particular be the case for demand from business end-users with multisite facility operations in different Member States. If that transnational demand is not sufficiently met by suppliers, for example if they are fragmented along national borders or locally, a potential internal market barrier arises. Therefore, BEREC should be empowered to provide guidelines to national regulatory authorities on common regulatory approaches to ensure that transnational demand can be met in a satisfactory way, providing a basis for the interoperability of wholesale access products across the Union and permitting efficiencies and economies of scale despite the fragmented supply side. BEREC\u2019s guidelines should shape the choices of national regulatory authorities in pursuing the internal market objective when imposing regulatory obligations on undertakings designated as having significant market power at national level while providing guidance for the harmonisation of technical specifications of wholesale access products capable of meeting such identified transnational demand, in the interest of the internal market. (168) The objective of any ex ante regulatory intervention is ultimately to produce benefits for end-users in terms of price, quality and choice by making retail markets effectively competitive on a sustainable basis. It is likely that national regulatory authorities will gradually be able to find many retail markets to be competitive even in the absence of wholesale regulation, especially taking into account expected improvements in innovation and competition. (169) For national regulatory authorities, the starting point for the identification of wholesale markets susceptible to ex ante regulation is the analysis of corresponding retail markets. The analysis of effective competition at the retail and at the wholesale level is conducted from a forward-looking perspective over a given time horizon, and is guided by competition law, including, as appropriate, the relevant case law of the Court of Justice. If it is concluded that a retail market would be effectively competitive in the absence of ex ante wholesale regulation on the corresponding relevant markets, this should lead the national regulatory authority to conclude that regulation is no longer needed at the relevant wholesale level. (170) During the gradual transition to deregulated markets, commercial agreements, including for co-investment and access between operators will gradually become more common, and if they are sustainable and improve competitive dynamics, they can contribute to the conclusion that a particular wholesale market does not warrant ex ante regulation. A similar logic would apply in reverse, to the unforeseeable termination of commercial agreements on a deregulated market. The analysis of such agreements should take into account that the prospect of regulation can be a motive for network owners to enter into commercial negotiations. With a view to ensuring adequate consideration of the impact of regulation imposed on related markets when determining whether a given market warrants ex ante regulation, national regulatory authorities should ensure markets are analysed in a consistent manner and where possible, at the same time or as close as possible to each other in time. (171) When assessing wholesale regulation to solve problems at the retail level, national regulatory authorities should take into account the fact that several wholesale markets can provide wholesale upstream inputs for a particular retail market, and, conversely, that a single wholesale market can provide wholesale upstream inputs for a variety of retail markets. Furthermore, competitive dynamics in a particular market can be influenced by markets that are contiguous but not in a vertical relationship, such as can be the case between certain fixed and mobile markets. National regulatory authorities should conduct that assessment for each individual wholesale market considered for regulation, starting with remedies for access to civil infrastructure, as such remedies are usually conducive to more sustainable competition including infrastructure competition, and thereafter analysing any wholesale markets considered susceptible to ex ante regulation in order of their likely suitability to address identified competition problems at retail level. When deciding on the specific remedy to be imposed, national regulatory authorities should assess its technical feasibility and carry out a cost-benefit analysis, having regard to its degree of suitability to address the identified competition problems at retail level, and enabling competition based on differentiation and technology neutrality. National regulatory authorities should consider the consequences of imposing any specific remedy which, if feasible only on certain network topologies, could constitute a disincentive for the deployment of very high capacity networks in the interest of end-users. (172) Without prejudice to the principle of technology neutrality, the national regulatory authorities should provide incentives through the remedies imposed, and, where possible, before the roll-out of infrastructure, for the development of flexible and open network architecture, which would reduce eventually the burden and complexity of remedies imposed at a later stage. At each stage of the assessment, before the national regulatory authority determines whether any additional, more burdensome, remedy should be imposed on the undertaking designated as having significant market power, it should seek to determine whether the retail market concerned would be effectively competitive, also taking into account any relevant commercial arrangements or other wholesale market circumstances, including other types of regulation already in force, such as for example general access obligations to non-replicable assets or obligations imposed pursuant to Directive 2014/61/EU, and of any regulation already considered to be appropriate by the national regulatory authority for an undertaking designated as having significant market power. Such an assessment, aiming to ensure that only the most appropriate remedies necessary to effectively address any problems identified in the market analysis are imposed, does not preclude a national regulatory authority from finding that a mix of such remedies together, even if of differing intensity, in line with the proportionality principle, offers the least intrusive way of addressing the problem. Even if such differences do not result in the definition of distinct geographic markets, they should be able to justify differentiation in the appropriate remedies imposed in light of the differing intensity of competitive constraints. (173) Ex ante regulation imposed at the wholesale level, which is in principle less intrusive than retail regulation, is considered to be sufficient to tackle potential competition problems on the related downstream retail market or markets. The advances in the functioning of competition since the regulatory framework for electronic communications has been in place are demonstrated by the progressive deregulation of retail markets across the Union. Furthermore, the rules relating to the imposition of ex ante remedies on undertakings designated as having significant market power should, where possible, be simplified and be made more predictable. Therefore, the imposition of ex ante regulatory controls based on an undertaking\u2019s designation as having significant market power in wholesale markets should prevail. (174) When a national regulatory authority withdraws wholesale regulation, it should define an appropriate notice period to ensure a sustainable transition to a de-regulated market. In defining such a notice period, the national regulatory authority should take into account the existing agreements between access providers and access seekers that have been entered into on the basis of the imposed regulatory obligations. In particular, such agreements can provide a contractual legal protection to access seekers for a determined period. The national regulatory authority should also take into account the effective possibility for market participants to take up any commercial wholesale access or co-investment offers which can be present in the market and the need to avoid an extended period of possible regulatory arbitrage. Transition arrangements established by the national regulatory authority should consider the extent and timing of regulatory oversight of pre-existing agreements, once the notice period starts. (175) In order to provide market players with certainty as to regulatory conditions, a time limit for market reviews is necessary. It is important to conduct a market analysis on a regular basis and within a reasonable and appropriate time-frame. There is a risk that failure by a national regulatory authority to analyse a market within the time-limit jeopardises the internal market, and normal infringement proceedings do not produce their desired effect on time. Alternatively, the national regulatory authority concerned should be able to request the assistance of BEREC to complete the market analysis. Such assistance could, for example, take the form of a specific task force composed of representatives of other national regulatory authorities. (176) Due to the high level of technological innovation and highly dynamic markets in the electronic communications sector, there is a need to adapt regulation rapidly in a coordinated and harmonised way at Union level, as experience has shown that divergence among the national regulatory authorities in the implementation of the regulatory framework may create a barrier to the internal market. (177) However, in the interest of greater stability and predictability of regulatory measures, the maximum period allowed between market analyses should be extended from three to five years, provided market changes in the intervening period do not require a new analysis. In determining whether a national regulatory authority has complied with its obligation to analyse markets and notified the corresponding draft measure at a minimum every five years, only a notification including a new assessment of the market definition and of significant market power will be considered to be starting a new five-year market cycle. A mere notification of new or amended regulatory remedies, imposed on the basis of a previous and unrevised market analysis will not be considered to have satisfied that obligation. Non-compliance by a national regulatory authority with the obligation to conduct market analysis at regular intervals laid down in this Directive should not be considered, in itself, to be a ground for the invalidity or inapplicability of existing obligations imposed by that national regulatory authority in the market in question. (178) The imposition of a specific obligation on an undertaking designated as having significant market power does not require an additional market analysis but rather a justification that the obligation in question is appropriate and proportionate in relation to the nature of the problem identified on the market in question, and on the related retail market. (179) When assessing the proportionality of the obligations and conditions to be imposed, national regulatory authorities should take into account the different competitive conditions existing in the different areas within their Member States having regard in particular to the results of the geographical survey conducted in accordance with this Directive. (180) When considering whether to impose remedies to control prices, and if so in what form, national regulatory authorities should seek to allow a fair return for the investor on a particular new investment project. In particular, there are risks associated with investment projects specific to new access networks which support products for which demand is uncertain at the time the investment is made. (181) Reviews of obligations imposed on undertakings designated as having significant market power during the timeframe of a market analysis should allow national regulatory authorities to take into account the impact on competitive conditions of new developments, for instance of newly concluded voluntary agreements between undertakings, such as access and co-investment agreements, thus providing the flexibility which is particularly necessary in the context of longer regulatory cycles. A similar logic should apply in the case of an unforeseeable breach or termination of a commercial agreement, or if such an agreement has effects diverging from the market analysis. If the termination of an existing agreement occurs in a deregulated market, it is possible that a new market analysis is required. In the absence of a single important change in the market but in the case of dynamic markets, it may be necessary to conduct a market analysis more often than every five years, for example not earlier than every three years as was the case until the date of application of this Directive. Markets should be considered to be dynamic if the technological evolution and end-user demand patterns are likely to evolve in such a way that the conclusions of the analysis would be superseded within the medium term for a significant group of geographic areas or of end-users within the geographic and product market defined by the national regulatory authority. (182) Transparency of terms and conditions for access and interconnection, including prices, serve to speed up negotiation, avoid disputes and give confidence to market players that a service is not being provided on discriminatory terms. Openness and transparency of technical interfaces can be particularly important in ensuring interoperability. Where a national regulatory authority imposes obligations to make information public, it should also be able to specify the manner in which the information is to be made available, and whether it is free of charge, taking into account the nature and purpose of the information concerned. (183) In light of the variety of network topologies, access products and market circumstance that have arisen since 2002, the objectives of Annex II to Directive 2002/19/EC, concerning local loop unbundling, and access products for providers of digital television and radio services, can be better achieved and in a more flexible manner, by providing guidelines on the minimum criteria for a reference offer to be developed by and periodically updated by BEREC. That Annex should therefore be deleted. (184) The principle of non-discrimination ensures that undertakings with significant market power do not distort competition, in particular where they are vertically integrated undertakings that supply services to undertakings with whom they compete on downstream markets. (185) In order to address and prevent non-price related discriminatory behaviour, equivalence of inputs (EoI) is in principle the surest way of achieving effective protection from discrimination. On the other hand, providing regulated wholesale inputs on an EoI basis is likely to trigger higher compliance costs than other forms of non-discrimination obligations. Those higher compliance costs should be measured against the benefits of more vigorous competition downstream, and of the relevance of non-discrimination guarantees in circumstances where the undertaking designated as having significant market power is not subject to direct price controls. In particular, national regulatory authorities might consider that the provision of wholesale inputs over new systems on an EoI basis is more likely to create sufficient net benefits, and thus be proportionate, given the comparatively lower incremental compliance costs to ensure that newly built systems are EoI-compliant. On the other hand, national regulatory authorities should also consider whether obligations are proportionate for affected undertakings, for example, by taking into account implementation costs and weigh up possible disincentives to the deployment of new systems, relative to more incremental upgrades, in the event that the former would be subject to more restrictive regulatory obligations. In Member States with a high number of small-scale undertakings designated as having significant market power, the imposition of EoI on each of those undertakings can be disproportionate. (186) Accounting separation allows internal price transfers to be rendered visible, and allows national regulatory authorities to check compliance with obligations for non-discrimination where applicable. In this regard the Commission published Recommendation 2005/698/EC (35). (187) Civil engineering assets that can host an electronic communications network are crucial for the successful roll-out of new networks because of the high cost of duplicating them, and the significant savings that can be made when they can be reused. Therefore, in addition to the rules on physical infrastructure laid down in Directive 2014/61/EU, a specific remedy is necessary in those circumstances where civil engineering assets are owned by an undertaking designated as having significant market power. Where civil engineering assets exist and are reusable, the positive effect of achieving effective access to them on the roll-out of competing infrastructure is very high, and it is therefore necessary to ensure that access to such assets can be used as a self-standing remedy for the improvement of competitive and deployment dynamics in any downstream market, to be considered before assessing the need to impose any other potential remedies, and not just as an ancillary remedy to other wholesale products or services or as a remedy limited to undertakings availing themselves of such other wholesale products or services. National regulatory authorities should value reusable legacy civil engineering assets on the basis of the regulatory accounting value net of the accumulated depreciation at the time of calculation, indexed by an appropriate price index, such as the retail price index, and excluding those assets which are fully depreciated, over a period of not less than 40 years, but still in use. (188) National regulatory authorities should, when imposing obligations for access to new and enhanced infrastructures, ensure that access conditions reflect the circumstances underlying the investment decision, taking into account, inter alia, the roll-out costs, the expected rate of take up of the new products and services and the expected retail price levels. Moreover, in order to provide planning certainty to investors, national regulatory authorities should be able to set, if applicable, terms and conditions for access which are consistent over appropriate review periods. In the event that price controls are considered to be appropriate, such terms and conditions can include pricing arrangements which depend on volumes or length of contract in accordance with Union law and provided they have no discriminatory effect. Any access conditions imposed should respect the need to preserve effective competition in services to consumers and businesses. (189) Mandating access to network infrastructure can be justified as a means of increasing competition, but national regulatory authorities need to balance the rights of an infrastructure owner to exploit its infrastructure for its own benefit, and the rights of other service providers to access facilities that are essential for the provision of competing services. (190) In markets where an increased number of access networks can be expected on a forward-looking basis, end-users are more likely to benefit from improvements in network quality, by virtue of infrastructure-based competition, compared to markets where only one network persists. The adequacy of competition on other parameters, such as price and choice, is likely to depend on the national and local competitive circumstances. In assessing the adequacy of competition on such parameters and the need for regulatory intervention, national regulatory authorities should also take into account whether wholesale access is available to any interested undertaking on reasonable commercial terms permitting sustainable competitive outcomes for end-users on the retail market. The application of general competition rules in markets characterised by sustainable and effective infrastructure-based competition should be sufficient. (191) Where obligations are imposed on undertakings that require them to meet reasonable requests for access to and use of networks elements and associated facilities, such requests should be refused only on the basis of objective criteria such as technical feasibility or the need to maintain network integrity. Where access is refused, the aggrieved party should be able to submit the case to the dispute resolutions procedures under this Directive. An undertaking with mandated access obligations cannot be required to provide types of access which it is not within its power to provide. The imposition by national regulatory authorities of mandated access that increases competition in the short term should not reduce incentives for competitors to invest in alternative facilities that will secure more sustainable competition or higher performance and end-user benefits in the long term. When choosing the least intrusive regulatory intervention, and in line with the principle of proportionality, national regulatory authorities could, for example, decide to review the obligations imposed on undertakings designated as having significant market power and amend any previous decision, including by withdrawing obligations, imposing or not imposing new access obligations if this is in the interests of users and sustainable service competition. National regulatory authorities should be able to impose technical and operational conditions on the provider or beneficiaries of mandated access in accordance with Union law. In particular the imposition of technical standards should comply with Directive (EU) 2015/1535. (192) Price control may be necessary when market analysis in a particular market reveals inefficient competition. In particular, undertakings designated as having significant market power should avoid a price squeeze whereby the difference between their retail prices and the interconnection or access prices charged to competitors who provide similar retail services is not adequate to ensure sustainable competition. When a national regulatory authority calculates costs incurred in establishing a service mandated under this Directive, it is appropriate to allow a reasonable return on the capital employed including appropriate labour and building costs, with the value of capital adjusted where necessary to reflect the current valuation of assets and efficiency of operations. The method of cost recovery should be appropriate to the circumstances taking account of the need to promote efficiency, sustainable competition and deployment of very high capacity networks and thereby maximise end-user benefits, and should take in account the need to have predictable and stable wholesale prices for the benefit of all operators seeking to deploy new and enhanced networks, in accordance with Commission Recommendation 2013/466/EU (36). (193) Due to uncertainty regarding the rate of materialisation of demand for the provision of next-generation broadband services, it is important in order to promote efficient investment and innovation to allow those operators investing in new or upgraded networks a certain degree of pricing flexibility. National regulatory authorities should be able to decide to maintain or not to impose regulated wholesale access prices on next-generation networks if sufficient competition safeguards are present. More specifically, to prevent excessive prices in markets where there are undertakings designated as having significant market power, pricing flexibility should be accompanied by additional safeguards to protect competition and end-user interests, such as strict non-discrimination obligations, measures to ensure technical and economic replicability of downstream products, and a demonstrable retail price constraint resulting from infrastructure competition or a price anchor stemming from other regulated access products, or both. Those competitive safeguards do not prejudice the identification by national regulatory authorities of other circumstances under which it would be appropriate not to impose regulated access prices for certain wholesale inputs, such as where high price elasticity of end-user demand makes it unprofitable for the undertaking designated as having significant market power to charge prices appreciably above the competitive level or where lower population density reduces the incentives for the development of very high capacity networks and the national regulatory authority establishes that effective and non-discriminatory access is ensured through obligations imposed in accordance with this Directive. (194) Where a national regulatory authority imposes obligations to implement a cost-accounting system in order to support price controls, it should be able to undertake an annual audit to ensure compliance with that cost-accounting system, provided that it has the necessary qualified staff, or to require such an audit to be carried out by another qualified body, independent of the undertaking concerned. (195) The charging system in the Union for wholesale voice call termination is based on Calling Party Network Pays. An analysis of demand and supply substitutability shows that currently or in the foreseeable future, there are no substitutes at wholesale level which might constrain the setting of charges for termination in a given network. Taking into account the two-way access nature of termination markets, further potential competition problems include cross-subsidisation between operators. Those potential competition problems are common to both fixed and mobile voice call termination markets. Therefore, in light of the ability and incentives of terminating operators to raise prices substantially above cost, cost orientation is considered to be the most appropriate intervention to address this concern over the medium term. Future market developments may alter the dynamics of those markets to the extent that regulation would no longer be necessary. (196) In order to reduce the regulatory burden in addressing the competition problems relating to wholesale voice call termination consistently across the Union, the Commission should establish, by means of a delegated act, a single maximum voice termination rate for mobile services and a single maximum voice termination rate for fixed services that apply Union-wide. (197) This Directive should lay down the detailed criteria and parameters on the basis of which the values of voice call termination rates are set. Termination rates across the Union have decreased consistently and are expected to continue to do so. When the Commission determines the maximum termination rates in the first delegated act that it adopts pursuant to this Directive, it should disregard any unjustified exceptional national deviation from that trend. (198) Due to current uncertainty regarding the rate of materialisation of demand for very high capacity broadband services as well as general economies of scale and density, co-investment agreements offer significant benefits in terms of pooling of costs and risks, enabling smaller-scale undertakings to invest on economically rational terms and thus promoting sustainable, long-term competition, including in areas where infrastructure-based competition might not be efficient. Such co-investments can take different forms, including co-ownership of network assets or long-term risk sharing through co-financing or through purchase agreements. In that context, purchase agreements which constitute co-investments entail the acquisition of specific rights to capacity of a structural character, involving a degree of co-determination and enabling co-investors to compete effectively and sustainably in the long term in downstream markets in which the undertaking designated as having significant market power is active. By contrast, commercial access agreements that are limited to the rental of capacity do not give rise to such rights and therefore should not be considered to be co-investments. (199) Where an undertaking designated as having significant market power makes an offer for co-investment on fair, reasonable and non-discriminatory terms in very high capacity networks that consist of optical fibre elements up to the end-user premises or the base station, providing an opportunity to undertakings of different sizes and financial capacity to become infrastructure co-investors, the national regulatory authority should be able to refrain from imposing obligations pursuant to this Directive on the new very high capacity network if at least one potential co-investor has entered into a co-investment agreement with that undertaking. Where a national regulatory authority decides to make binding a co-investment offer that has not resulted in an agreement, and decides, not to impose additional regulatory obligations, it can do so, subject to the condition that such an agreement is to be concluded before the deregulatory measure takes effect. Where it is technically impracticable to deploy optical fibre elements up to the end-user\u2019s premises, very high capacity networks consisting of optical fibre elements up to the immediate proximity of, meaning just outside, such premises should also be able to benefit from the same regulatory treatment. (200) When making a determination to refrain from imposing obligations, the national regulatory authority should take such steps after ensuring that the co-investment offers comply with the necessary criteria and are made in good faith. The differential regulatory treatment of new very high capacity networks should be subject to review in subsequent market analyses which, in particular after some time has elapsed, may require adjustments to the regulatory treatment. In duly justified circumstances, national regulatory authorities should be able to impose obligations on such new network elements when they establish that certain markets would, in the absence of regulatory intervention, face significant competition problems. In particular, when there are multiple downstream markets that have not reached the same degree of competition, national regulatory authorities could require specific asymmetric remedies to promote effective competition, for instance, but not limited to, niche retail markets, such as electronic communications products for business end-users. To maintain the competitiveness of the markets, national regulatory authorities should also safeguard the rights of access seekers who do not participate in a given co-investment. This should be achieved through the maintenance of existing access products or, where legacy network elements are dismantled in due course, through the imposition of access products with at least comparable functionality and quality to those previously available on the legacy infrastructure, in both cases subject to an appropriate adaptable mechanism validated by the national regulatory authority that does not undermine the incentives for co-investors. (201) In order to enhance the consistent regulatory practice across the Union, where national regulatory authorities conclude that the conditions of the co-investment offer are met, the Commission should be able to require the national regulatory authority to withdraw its draft measures either refraining from imposing obligations or intervening with regulatory obligations in order to address significant competition problems, where BEREC shares the Commission\u2019s serious doubts as to the compatibility of the draft measure with Union law and in particular the regulatory objectives of this Directive. In the interest of efficiency, a national regulatory authority should be able to submit a single notification to the Commission of a draft measure that relates to a co-investment scheme that meets the relevant conditions. Where the Commission does not exercise its powers to require the withdrawal of the draft measure, it would be disproportionate for subsequent simplified notifications of individual draft decisions of the national regulatory authority on the basis of the same scheme, including in addition evidence of actual conclusion of an agreement with at least one co-investor, to be subject to a decision requiring withdrawal in the absence of a change in circumstances. Furthermore, obligations imposed on undertakings, irrespective of whether they are designated as having significant market power, pursuant to this Directive or to Directive 2014/61/EU continue to apply. Obligations in relation to co-investment agreements are without prejudice to the application of Union law. (202) The purpose of functional separation, whereby the vertically integrated undertaking is required to establish operationally separate business entities, is to ensure the provision of fully equivalent access products to all downstream operators, including the operator\u2019s own vertically integrated downstream divisions. Functional separation has the capacity to improve competition in several relevant markets by significantly reducing the incentive for discrimination and by making it easier to verify and enforce compliance with non-discrimination obligations. In exceptional cases, it should be possible for functional separation to be justified as a remedy where there has been persistent failure to achieve effective non-discrimination in several of the markets concerned, and where there is little or no prospect of infrastructure competition within a reasonable time-frame after recourse to one or more remedies previously considered to be appropriate. However, it is very important to ensure that its imposition preserves the incentives of the undertaking concerned to invest in its network and that it does not entail any potential negative effects on consumer welfare. Its imposition requires a coordinated analysis of different relevant markets related to the access network, in accordance with the market analysis procedure. When undertaking the market analysis and designing the details of that remedy, national regulatory authorities should pay particular attention to the products to be managed by the separate business entities, taking into account the extent of network roll-out and the degree of technological progress, which may affect the substitutability of fixed and wireless services. In order to avoid distortions of competition in the internal market, proposals for functional separation should be approved in advance by the Commission. (203) The implementation of functional separation should not prevent appropriate coordination mechanisms between the different separate business entities in order to ensure that the economic and management supervision rights of the parent company are protected. (204) Where a vertically integrated undertaking chooses to transfer a substantial part or all of its local access network assets to a separate legal entity under different ownership or by establishing a separate business entity for dealing with access products, the national regulatory authority should assess the effect of the intended transaction, including any access commitments offered by this undertaking, on all existing regulatory obligations imposed on the vertically integrated undertaking in order to ensure the compatibility of any new arrangements with this Directive. The national regulatory authority concerned should undertake a new analysis of the markets in which the segregated entity operates, and impose, maintain, amend or withdraw obligations accordingly. To that end, the national regulatory authority should be able to request information from the undertaking. (205) It is already possible today in some markets that as part of the market analysis the undertakings designated as having significant market power are able to offer commitments which aim to address competition problems identified by the national regulatory authority and which the national regulatory authority then takes into account in deciding on the appropriate regulatory obligations. Any new market developments should be taken into account in deciding on the most appropriate remedies. However, and without prejudice to the provisions on regulatory treatment of co-investments, the nature of the commitments offered as such does not limit the discretion accorded to the national regulatory authority to impose remedies on undertakings designated as having significant market power. In order to enhance transparency and to provide legal certainty across the Union, the procedure for undertakings to offer commitments and for the national regulatory authorities to assess them, taking into account the views of market participants by means of a market test, and if appropriate to make them binding on the committing undertaking and enforceable by the national regulatory authority, should be laid down in this Directive. Unless the national regulatory authority has made commitments on co-investments binding and decided not to impose obligations, that procedure is without prejudice to the application of the market analysis procedure and the obligation to impose appropriate and proportionate remedies to address the identified market failure. (206) National regulatory authorities should be able to make the commitments binding, wholly or in part, for a specific period which should not exceed the period for which they are offered, after having conducted a market test by means of a public consultation of interested parties. Where the commitments have been made binding, the national regulatory authority should consider the consequences of this decision in its market analysis and take them into account when choosing the most appropriate regulatory measures. National regulatory authorities should consider the commitments made from a forward-looking perspective of sustainability, in particular when choosing the period for which they are made binding, and should have regard to the value placed by stakeholders in the public consultation on stable and predictable market conditions. Binding commitments related to voluntary separation by a vertically integrated undertaking which has been designated as having significant market power in one or more relevant markets can add predictability and transparency to the process, by setting out the process of implementation of the planned separation, for example by providing a roadmap for implementation with clear milestones and predictable consequences if certain milestones are not met. (207) The commitments can include the appointment of a monitoring trustee, whose identity and mandate should be approved by the national regulatory authority, and the obligation on the undertaking offering them to provide periodic implementation reports. (208) Network owners whose business model is limited to the provision of wholesale services to others, can be beneficial to the creation of a thriving wholesale market, with positive effects on retail competition downstream. Furthermore, their business model can be attractive to potential financial investors in less volatile infrastructure assets and with longer term perspectives on deployment of very high capacity networks. Nevertheless, the presence of a wholesale-only undertaking does not necessarily lead to effectively competitive retail markets, and wholesale-only undertakings can be designated as having significant market power in particular product and geographic markets. Certain competition risks arising from the behaviour of undertakings following wholesale-only business models might be lower than for vertically integrated undertakings, provided the wholesale-only model is genuine and no incentives to discriminate between downstream providers exist. The regulatory response should therefore be commensurately less intrusive, but should preserve in particular the possibility to introduce obligations in relation to fair and reasonable pricing. On the other hand, national regulatory authorities should be able to intervene if competition problems have arisen to the detriment of end-users. An undertaking active on a wholesale market that supplies retail services solely to business users larger than small and medium-sized enterprises should be regarded as a wholesale-only undertaking. (209) To facilitate the migration from legacy copper networks to next-generation networks, which is in the interests of end-users, national regulatory authorities should be able to monitor network operators\u2019 own initiatives in this respect and to establish, where necessary, the conditions for an appropriate migration process, for example by means of prior notice, transparency and availability of alternative access products of at least comparable quality, once the network owner has demonstrated the intent and readiness to switch to upgraded networks. In order to avoid unjustified delays to the migration, national regulatory authorities should be empowered to withdraw access obligations relating to the copper network once an adequate migration process has been established and compliance with conditions and process for migration from legacy infrastructure is ensured. However, network owners should be able to decommission legacy networks. Access seekers migrating from an access product based on legacy infrastructure to an access product based on a more advanced technology or medium should be able to upgrade their access to any regulated product with higher capacity, but should not be required to do so. In the case of an upgrade, access seekers should adhere to the regulatory conditions for access to the higher capacity access product, as determined by the national regulatory authority in its market analysis. (210) The liberalisation of the telecommunications sector and increasing competition and choice for communications services go hand in hand with parallel action to create a harmonised regulatory framework which secures the delivery of universal service. The concept of universal service should evolve to reflect advances in technology, market developments and changes in user demand. (211) Under Article 169 TFEU, the Union is to contribute to the protection of consumers. (212) Universal service is a safety net to ensure that a set of at least the minimum services is available to all end-users and at an affordable price to consumers, where a risk of social exclusion arising from the lack of such access prevents citizens from full social and economic participation in society. (213) Basic broadband internet access is virtually universally available across the Union and very widely used for a broad range of activities. However, the overall take-up rate is lower than availability as there are still those who are disconnected due to reasons related to awareness, cost, skills and due to choice. Affordable adequate broadband internet access has become of crucial importance to society and the wider economy. It provides the basis for participation in the digital economy and society through essential online internet services. (214) A fundamental requirement of universal service is to ensure that all consumers have access at an affordable price to an available adequate broadband internet access and voice communications services, at a fixed location. Member States should also have the possibility to ensure affordability of adequate broadband internet access and voice communications services other than at a fixed location to citizens on the move, where they consider that this is necessary to ensure consumers' full social and economic participation in society. Particular attention should be paid in that context to ensuring that end-users with disabilities have equivalent access. There should be no limitations on the technical means by which the connection is provided, allowing for wired or wireless technologies, nor any limitations on the category of providers which provide part or all of universal service obligations. (215) The speed of internet access experienced by a given user depends on a number of factors, including the providers of internet connectivity as well as the given application for which a connection is being used. It is for the Member States, taking into account BEREC\u2019s report on best practices, to define adequate broadband internet access in light of national conditions and the minimum bandwidth enjoyed by the majority of consumers within a Member State\u2019s territory in order to allow an adequate level of social inclusion and participation in the digital economy and society in their territory. The affordable adequate broadband internet access service should have sufficient bandwidth to support access to and use of at least a minimum set of basic services that reflect the services used by the majority of end-users. To that end, the Commission should monitor the development in the use of the internet to identify those online services used by a majority of end-users across the Union and necessary for social and economic participation in society and update the list accordingly. The requirements of Union law on open internet access, in particular of Regulation (EU) 2015/2120, should apply to any adequate broadband internet access service. (216) Consumers should not be obliged to access services they do not want and it should therefore be possible for eligible consumers to restrict, on request, the affordable universal service to voice communications services. (217) Member States should be able to extend measures related to affordability and control of expenditure measures to microenterprises and small and medium-sized enterprises and not-for-profit organisations, provided they fulfil the relevant conditions. (218) National regulatory authorities in coordination with other competent authorities should be able to monitor the evolution and level of retail tariffs for services that fall within the scope of universal service obligations. Such monitoring should be carried out in such a way that it would not represent an excessive administrative burden for either national regulatory and other competent authorities or providers of such services. (219) An affordable price means a price defined by Member States at national level in light of specific national conditions. Where Member States establish that retail prices for adequate broadband internet access and voice communications services are not affordable to consumers with low-income or special social needs, including older people, end-users with disabilities and consumers living in rural or geographically isolated areas, they should take appropriate measures. To that end, Member States could provide those consumers with direct support for communication purposes, which could be part of social allowances or vouchers for, or direct payments to, those consumers. This can be an appropriate alternative having regard to the need to minimise market distortions. Alternatively, or in addition, Member States could require providers of such services to offer basic tariff options or packages to those consumers. (220) Ensuring affordability may involve special tariff options or packages to deal with the needs of low-income users or users with special social needs. Such offers should be provided with basic features, in order to avoid distortion of the functioning of the market. Affordability for individual consumers should be founded upon their right to contract with a provider, availability of a number, continued connection of service and their ability to monitor and control their expenditure. (221) Where a Member State requires providers to offer to consumers with a low-income or special social needs tariff options or packages different from those provided under normal commercial conditions, those tariff options or packages should be provided by all providers of internet access and voice communication services. In accordance with the principle of proportionality, requiring all providers of internet access and voice communication services to offer tariff options or packages should not result in excessive administrative or financial burden for those providers or Member States. Where a Member State demonstrates such an excessive administrative or financial burden, on the basis of an objective assessment, it might exceptionally decide to impose the obligation to offer specific tariff options or packages only on designated providers. The objective assessment should also consider the benefits arising for consumers with a low-income or special social needs from a choice of providers and the benefits for all providers being able to benefit from being a universal service provider. Where a Member State exceptionally decides to impose the obligation to offer specific tariff options or packages only on designated providers, they should ensure that consumers with low income or special needs have a choice of providers offering social tariffs. However, in certain situations Member States might not be able to guarantee a choice of providers, for example where only one undertaking provides services in the area of residence of the beneficiary, or if providing a choice would put an excessive additional organisational and financial burden on the Member State. (222) Affordability should no longer be a barrier to consumers\u2019 access to the minimum set of connectivity services. A right to contract with a provider should mean that consumers who might face refusal, in particular those with a low-income or special social needs, should have the possibility to enter into a contract for the provision of affordable adequate broadband internet access and voice communications services at least at a fixed location with any provider of such services in that location or a designated provider, where a Member State has exceptionally decided to designate one or more providers to offer those tariff options or packages. In order to minimise the financial risks such as non-payment of bills, providers should be free to provide the contract under pre-payment terms, on the basis of affordable individual pre-paid units. (223) In order to ensure that citizens are reachable by voice communications services, Member States should ensure the availability of a number for a reasonable period also during periods of non-use of voice communications services. Providers should be able to put in place mechanisms to check the continued interest of the consumer in keeping the availability of the number. (224) Compensating providers of such services in such circumstances need not result in the distortion of competition, provided that such providers are compensated for the specific net cost involved and provided that the net cost burden is recovered in a competitively neutral way. (225) In order to assess the need for affordability measures, national regulatory authorities in coordination with other competent authorities should be able to monitor the evolution and details of offers of tariff options or packages for consumers with a low-income or special social needs. (226) Member States should introduce measures to promote the creation of a market for affordable products and services incorporating facilities for consumers with disabilities, including equipment with assistive technologies. This can be achieved, inter alia, by referring to European standards, or by supporting the implementation of requirements under Union law harmonising accessibility requirements for products and services. Member States should introduce appropriate measures in accordance with national circumstances, which gives flexibility for Member States to take specific measures for instance if the market is not delivering affordable products and services incorporating facilities for consumers with disabilities under normal economic conditions. Those measures could include direct financial support to end-users. The cost to consumers with disabilities of relay services should be equivalent to the average cost of voice communications services. (227) Relay services refer to services which enable two-way communication between remote end-users of different modes of communication (for example text, sign, speech) by providing conversion between those modes of communication, normally by a human operator. Real time text is defined in accordance with Union law harmonising accessibility requirements for products and services and refers to form of text conversation in point to point situations or in multipoint conferencing where the text being entered is sent in such a way that the communication is perceived by the user as being continuous on a character-by-character basis. (228) For data communications at data rates that are sufficient to permit an adequate broadband internet access, fixed-line connections are nearly universally available and used by a majority of citizens of the Union. The standard fixed broadband coverage and availability in the Union stood at 97 % of homes in 2015, with an average take-up rate of 72 %, and services based on wireless technologies have even greater reach. However, there are differences between Member States as regards availability and affordability of fixed broadband across urban and rural areas. (229) The market has a leading role to play in ensuring availability of broadband internet access with constantly growing capacity. In areas where the market would not deliver, other public policy tools to support availability of adequate broadband internet access connections appear, in principle, more cost-effective and less market-distortive than universal service obligations, for example recourse to financial instruments such as those available under the European Fund for Strategic Investments and Connecting Europe Facility, the use of public funding from the European structural and investment funds, attaching coverage obligations to rights of use for radio spectrum to support the deployment of broadband networks in less densely populated areas and public investment in accordance with Union State aid rules. (230) If, after carrying out a due assessment, taking into account the results of the geographical survey of networks deployment conducted by the competent authority, or the latest information available to the Member States before the results of the first geographical survey are available, it is shown that neither the market nor public intervention mechanisms are likely to provide end-users in certain areas with a connection capable of delivering adequate broadband internet access service as defined by Member States and voice communications services at a fixed location, the Member State should be able to exceptionally designate different providers or sets of providers of those services in the different relevant parts of the national territory. In addition to the geographical survey, Member States should be able to use, where necessary, any additional evidence to establish to what extent adequate broadband internet access and voice communications services are available at a fixed location. That additional evidence could include data available to the national regulatory authorities through the market analysis procedure and data collected from users. Member States should be able to restrict universal service obligations in support of availability of adequate broadband internet access services to the end-user\u2019s primary location or residence. There should be no constraints on the technical means by which the adequate broadband internet access and voice communications services at a fixed location are provided, allowing for wired or wireless technologies, nor any constraints on which undertakings provide part or all of universal service obligations. (231) In accordance with the principle of subsidiarity, it is for the Member States to decide on the basis of objective criteria which undertakings are designated as universal service providers, where appropriate taking into account the ability and the willingness of undertakings to accept all or part of the universal service obligations. This does not preclude Member States from including, in the designation process, specific conditions justified on grounds of efficiency, including grouping geographical areas or components or setting minimum periods for the designation. (232) The costs of ensuring the availability of a connection capable of delivering an adequate broadband internet access service as identified in accordance with this Directive and voice communications services at a fixed location at an affordable price within the universal service obligations should be estimated, in particular by assessing the expected financial burden for providers and users in the electronic communications sector. (233) A priori, requirements to ensure nation-wide territorial coverage imposed in the designation procedure are likely to exclude or dissuade certain undertakings from applying for being designated as universal service providers. Designating providers with universal service obligations for an excessive or indefinite period might also lead to an a priori exclusion of certain providers. Where a Member State decides to designate one or more providers for affordability purposes, it should be possible for those providers to be different from those designated for the availability element of universal service. (234) When a provider that is, on an exceptional basis, designated to provide tariff options or packages different from those provided under normal commercial conditions, as identified in accordance with this Directive or to ensure the availability at a fixed location of an adequate broadband internet access service or voice communications services, as identified in accordance with this Directive, chooses to dispose of a substantial part, viewed in light of its universal service obligations, or all, of its local access network assets in the national territory to a separate legal entity under different ultimate ownership, the competent authority should assess the effects of the transaction in order to ensure the continuity of universal service obligations in all or parts of the national territory. To that end, the competent authority which imposed the universal service obligations should be informed by the provider in advance of the disposal. The assessment of the competent authority should not prejudice the completion of the transaction. (235) In order to provide stability and support a gradual transition, Member States should be able to continue to ensure the provision of universal service in their territory, other than adequate broadband internet access and voice communications services at a fixed location, that are included in the scope of their universal service obligations on the basis of Directive 2002/22/EC on the date of entry into force of this Directive, provided the services or comparable services are not available under normal commercial circumstances. Allowing the continuation of the provision of public payphones to the general public by use of coins, credit or debit cards, or pre-payment cards, including cards for use with dialling codes, directories and directory enquiry services under the universal service regime, for as long as the need is demonstrated, would give Member States the flexibility necessary to duly take into account the varying national circumstances. This can include providing public pay telephones in the main entry points of the country, such as airports or train and bus stations, as well as places used by people in the case of an emergency, such as hospitals, police stations and highway emergency areas, to meet the reasonable needs of end-users, including in particular end-users with disabilities. (236) Member States should monitor the situation of consumers with respect to their use of adequate broadband internet access and voice communications services and in particular with respect to affordability. The affordability of adequate broadband internet access and voice communications services is related to the information which users receive regarding usage expenses as well as the relative cost of usage compared to other services, and is also related to their ability to control expenditure. Affordability therefore means giving power to consumers through obligations imposed on providers. Those obligations include a specified level of itemised billing, the possibility for consumers selectively to block certain calls, such as high-priced calls to premium services, to control expenditure via pre-payment means, and to offset up-front connection fees. Such measures may need to be reviewed and changed in light of market developments. Itemised bills on the usage of internet access should indicate only the time, duration and amount of consumption during a usage session but not indicate the websites or internet end-points connected to during such a usage session. (237) Except in cases of persistent late payment or non-payment of bills, consumers entitled to affordable tariffs should, pending resolution of the dispute, be protected from immediate disconnection from the network on the grounds of an unpaid bill and, in particular, in the case of disputes over high bills for premium-rate services, continue to have access to essential voice communications services and a minimum service level of internet access as defined by Member States. It should be possible for Member States to decide that such access is to continue to be provided only if the subscriber continues to pay line rental or basic internet access charges. (238) Where the provision of adequate broadband internet access and voice communications services or the provision of other services in accordance with this Directive result in an unfair burden on a provider, taking due account of the costs and revenues as well as the intangible benefits resulting from the provision of the services concerned, that unfair burden can be included in any net cost calculation of universal service obligations. (239) Member States should, where necessary, establish mechanisms for financing the net cost of universal service obligations where it is demonstrated that the obligations can only be provided at a loss or at a net cost which falls outside normal commercial standards. It is important to ensure that the net cost of universal service obligations is properly calculated and that any financing is undertaken with minimum distortion to the market and to undertakings, and is compatible with Articles 107 and 108 TFEU. (240) Any calculation of the net cost of universal service obligations should take due account of costs and revenues, as well as the intangible benefits resulting from providing universal service, but should not hinder the general aim of ensuring that pricing structures reflect costs. Any net costs of universal service obligations should be calculated on the basis of transparent procedures. (241) Taking into account intangible benefits means that an estimate in monetary terms, of the indirect benefits that an undertaking derives by virtue of its position as universal service provider, should be deducted from the direct net cost of universal service obligations in order to determine the overall cost burden. (242) When a universal service obligation represents an unfair burden on a provider, it is appropriate to allow Member States to establish mechanisms for efficiently recovering net costs. Recovery via public funds constitutes one method of recovering the net costs of universal service obligations. Sharing the net costs of universal service obligations between providers of electronic communications networks and services is another method. Member States should be able to finance the net costs of different elements of universal service through different mechanisms, or to finance the net costs of some or all elements from either of the mechanisms or a combination of both. Adequate broadband internet access brings benefits not only to the electronic communications sector but also to the wider online economy and to society as a whole. Providing a connection which supports broadband speeds to an increased number of end-users enables them to use online services and so actively to participate in the digital society. Ensuring such connections on the basis of universal service obligations serves both the public interest and the interests of electronic communications providers. Those facts should be taken into account by Member States when choosing and designing mechanisms for recovering net costs. (243) In the case of cost recovery by means of sharing the net cost of universal service obligations between providers of electronic communications networks and services, Member States should ensure that the method of allocation amongst providers is based on objective and non-discriminatory criteria and is in accordance with the principle of proportionality. This principle does not prevent Member States from exempting new entrants which have not achieved any significant market presence. Any funding mechanism should ensure that market participants only contribute to the financing of universal service obligations and not to other activities which are not directly linked to the provision of the universal service obligations. Recovery mechanisms should respect the principles of Union law, and in particular in the case of sharing mechanisms those of non-discrimination and proportionality. Any funding mechanism should ensure that users in one Member State do not contribute to the costs of providing universal service in another Member State. It should be possible to share the net cost of universal service obligations between all or certain specified classes of providers. Member States should ensure that the sharing mechanism respects the principles of transparency, least market distortion, non-discrimination and proportionality. Least market distortion means that contributions should be recovered in a way that as far as possible minimises the impact of the financial burden falling on end-users, for example by spreading contributions as widely as possible. (244) Providers benefiting from universal service funding should provide national regulatory authorities with a sufficient level of detail of the specific elements requiring such funding in order to justify their request. Member States\u2019 schemes for the costing and financing of universal service obligations should be communicated to the Commission for verification of compatibility with the TFEU. Member States should ensure effective transparency and control of amounts charged to finance universal service obligations. Calculation of the net costs of providing universal service should be based on an objective and transparent methodology to ensure the most cost-effective provision of universal service and promote a level playing field for market participants. Making the methodology intended to be used to calculate the net costs of individual universal service elements known in advance before implementing the calculation could help to achieve increased transparency. (245) Member States are not permitted to impose on market participants financial contributions which relate to measures which are not part of the universal service obligations. Individual Member States remain free to impose special measures (outside the scope of universal service obligations) and finance them in accordance with Union law but not by means of contributions from market participants. (246) In order to effectively support the free movement of goods, services and persons within the Union, it should be possible to use certain national numbering resources, in particular certain non-geographic numbers, in an extraterritorial manner, that is to say outside the territory of the assigning Member State. In light of the considerable risk of fraud with respect to interpersonal communications, such extraterritorial use should be allowed only for the provision of electronic communications services other than interpersonal communications services. Enforcement of relevant national laws, in particular consumer protection rules and other rules related to the use of numbering resources should be ensured by Member States independently of where the rights of use have been granted and where the numbering resources are used within the Union. Member States remain competent to apply their national law to numbering resources used in their territory, including where rights have been granted in another Member State. (247) The national regulatory or other competent authorities of the Member States where numbering resources from another Member State are used, do not have control over those numbering resources. It is therefore essential that the national regulatory or other competent authority of the Member State which grants the rights of extraterritorial use should also ensure the effective protection of the end-users in the Member States where those numbers are used. In order to achieve effective protection, national regulatory or other competent authority granting rights of extraterritorial use should attach conditions in accordance with this Directive regarding the respect by the provider of consumer protection rules and other rules related to the use of numbering resources in those Member States where those resources will be used. (248) The national regulatory or other competent authorities of those Member States where numbering resources are used should be able to request the support of the national regulatory or other competent authorities that granted the rights of use for the numbering resources to assist in enforcing its rules. Enforcement measures by the national regulatory or other competent authorities that granted the rights of use should include dissuasive penalties, in particular in the case of a serious breach the withdrawal of the right of extraterritorial use for the numbering resources assigned to the undertaking concerned. The requirements on extraterritorial use should be without prejudice to Member States\u2019 powers to block, on a case-by-case basis, access to numbers or services where that is justified by reasons of fraud or misuse. The extraterritorial use of numbering resources should be without prejudice to Union rules related to the provision of roaming services, including those relative to preventing anomalous or abusive use of roaming services which are subject to retail price regulation and which benefit from regulated wholesale roaming rates. Member States should continue to be able to enter into specific agreements on extraterritorial use of numbering resources with third countries. (249) Member States should promote over-the-air provisioning of numbering resources to facilitate switching of electronic communications providers. Over-the-air provisioning of numbering resources enables the reprogramming of communications equipment identifiers without physical access to the devices concerned. This feature is particularly relevant for machine-to-machine services, that is to say services involving an automated transfer of data and information between devices or software-based applications with limited or no human interaction. Providers of such machine-to-machine services might not have recourse to physical access to their devices due to their use in remote conditions, or to the large number of devices deployed or to their usage patterns. In light of the emerging machine-to-machine market and new technologies, Member States should strive to ensure technology neutrality in promoting over-the-air provisioning. (250) Access to numbering resources on the basis of transparent, objective and non-discriminatory criteria is essential for undertakings to compete in the electronic communications sector. Member States should be able to grant rights of use for numbering resources to undertakings other than providers of electronic communications networks or services in light of the increasing relevance of numbers for various Internet of Things services. All elements of national numbering plans should be managed by national regulatory or other competent authorities, including point codes used in network addressing. Where there is a need for harmonisation of numbering resources in the Union to support the development of pan-European services or cross-border services, in particular new machine-to-machine-based services such as connected cars, and where the demand could not be met on the basis of the existing numbering resources in place, the Commission can take implementing measures with the assistance of BEREC. (251) It should be possible to fulfil the requirement to publish decisions on the granting of rights of use for numbering resources by making those decisions publicly accessible via a website. (252) Considering the particular aspects related to the reporting of missing children, Member States should maintain their commitment to ensure that a well-functioning service for reporting missing children is actually available in their territories under the number \u2018116000\u2019. Member States should take appropriate measures to ensure that a sufficient level of service quality in operating the \u2018116000\u2019 number is achieved. (253) In parallel with the missing children hotline number \u2018116000\u2019, many Member States also ensure that children have access to a child-friendly service operating a helpline that helps children in need of care and protection through the use of the \u2018116111\u2019 number. Such Member States and the Commission should ensure that awareness is raised among citizens, and in particular among children and among national child protection systems, about the existence of the \u2018116111\u2019 helpline. (254) An internal market implies that end-users are able to access all numbers included in the national numbering plans of other Member States and to access services using non-geographic numbers, including freephone and premium-rate numbers, within the Union, except where the called end-user has chosen, for commercial reasons, to limit access from certain geographical areas. End-users should also be able to access numbers from the Universal International Freephone Numbers (UIFN). Cross-border access to numbering resources and associated services should not be prevented, except in objectively justified cases, for example to combat fraud or abuse (for example, in connection with certain premium-rate services), when the number is defined as having a national scope only (for example, a national short code) or when it is economically unfeasible. Tariffs charged to parties calling from outside the Member State concerned need not be the same as for those parties calling from inside that Member State. Users should be fully informed in advance and in a clear manner of any charges applicable to freephone numbers, such as international call charges for numbers accessible through standard international dialling codes. Where interconnection or other service revenues are withheld by providers of electronic communications services for reasons of fraud or misuse, Member States should ensure that retained service revenues are refunded to the end-users affected by the relevant fraud or misuse where possible. (255) In accordance with the principle of proportionality, a number of provisions on end-user rights in this Directive should not apply to microenterprises which provide only number-independent interpersonal communications services. According to the case law of the Court of Justice, the definition of small and medium-sized enterprises, which includes microenterprises, is to be interpreted strictly. In order to include only enterprises that are genuinely independent microenterprises, it is necessary to examine the structure of microenterprises which form an economic group, the power of which exceeds the power of a microenterprise, and to ensure that the definition of microenterprise is not circumvented by purely formal means. (256) The completion of the single market for electronic communications requires the removal of barriers for end-users to have cross-border access to electronic communications services across the Union. Providers of electronic communications to the public should not deny or restrict access or discriminate against end-users on the basis of their nationality, or Member State of residence or of establishment. Differentiation should, however, be possible on the basis of objectively justifiable differences in costs and risks, not limited to the measures provided for in Regulation (EU) No 531/2012 in respect of abusive or anomalous use of regulated retail roaming services. (257) Divergent implementation of the rules on end-user protection has created significant internal market barriers affecting both providers of electronic communications services and end-users. Those barriers should be reduced by the applicability of the same rules ensuring a high common level of protection across the Union. A calibrated full harmonisation of the end-user rights covered by this Directive should considerably increase legal certainty for both end-users and providers of electronic communications services, and should significantly lower entry barriers and unnecessary compliance burden stemming from the fragmentation of the rules. Full harmonisation helps to overcome barriers to the functioning of the internal market resulting from such national provisions concerning end-user rights which at the same time protect national providers against competition from other Member States. In order to achieve a high common level of protection, several provisions concerning end-user rights should be reasonably enhanced in this Directive in light of best practices in Member States. Full harmonisation of their rights increases the trust of end-users in the internal market as they benefit from an equally high level of protection when using electronic communications services, not only in their Member State but also while living, working or travelling in other Member States. Full harmonisation should extend only to the subject matters covered by the provisions on end-user rights in this Directive. Therefore, it should not affect national law with respect to those aspects of end-user protection, including some aspects of transparency measures which are not covered by those provisions. For example, measures relating to transparency obligations which are not covered by this Directive should be considered to be compatible with the principle of full harmonisation whereas additional requirements regarding transparency issues covered by this Directive, such as publication of information, should be considered to be incompatible. Moreover, Member States should be able to maintain or introduce national provisions on issues not specifically addressed in this Directive, in particular in order to address newly emerging issues. (258) Contracts are an important tool for end- users to ensure transparency of information and legal certainty. Most service providers in a competitive environment will conclude contracts with their customers for reasons of commercial desirability. In addition to this Directive, the requirements of existing Union consumer protection law relating to contracts, in particular Council Directive 93/13/EEC (37) and Directive 2011/83/EU of the European Parliament and of the Council (38), apply to consumer transactions relating to electronic communications networks and services. The inclusion of information requirements in this Directive, which might also be required pursuant to Directive 2011/83/EU, should not lead to duplication of the information within pre-contractual and contractual documents. Relevant information provided in respect of this Directive, including any more prescriptive and more detailed informational requirements, should be considered to fulfil the corresponding requirements pursuant to Directive 2011/83/EU. (259) Some of those end-user protection provisions which a priori apply only to consumers, namely those on contract information, maximum contract duration and bundles, should benefit not only consumers, but also microenterprises and small enterprises, and not-for-profit organisations as defined in national law. The bargaining position of those categories of enterprises and organisations is comparable to that of consumers and they should therefore benefit from the same level of protection unless they explicitly waive those rights. Obligations on contract information in this Directive, including those of Directive 2011/83/EU that are referred to in this Directive, should apply irrespective of whether any payment is made and of the amount of the payment to be made by the customer. The obligations on contract information, including those contained in Directive 2011/83/EU, should apply automatically to microenterprises, small enterprises and not-for-profit organisations unless they prefer negotiating individualised contract terms with providers of electronic communications services. As opposed to microenterprises, small enterprises and not-for-profit organisations, larger enterprises usually have stronger bargaining power and do, therefore, not depend on the same contractual information requirements as consumers. Other provisions, such as number portability, which are important also for larger enterprises should continue to apply to all end-users. Not-for-profit organisations are legal entities that do not earn a profit for their owners or members. Typically, not-for-profit organisations are charities or other types of public interest organisations. Hence, in light of the comparable situation, it is legitimate to treat such organisations in the same way as microenterprises or small enterprises under this Directive, insofar as end-user rights are concerned. (260) The specificities of the electronic communications sector require, beyond horizontal contract rules, a limited number of additional end-user protection provisions. End-users should be informed, inter alia, of any quality of service levels offered, conditions for promotions and termination of contracts, applicable tariff plans and tariffs for services subject to particular pricing conditions. That information is relevant for providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services. Without prejudice to the applicable rules on the protection of personal data, a provider of publicly available electronic communications services should not be subject to the obligations on information requirements for contracts where that provider, and affiliated companies or persons, do not receive any remuneration directly or indirectly linked to the provision of electronic communications services, such as where a university gives visitors free access to its Wi-Fi network on campus without receiving any remuneration, whether through payment from the users or through advertising revenues. (261) In order to enable the end-user to make a well-informed choice, it is essential that the required relevant information is provided prior to the conclusion of the contract and in clear and understandable language and on a durable medium or, where not feasible and without prejudice to the definition of durable medium set out in Directive 2011/83/EU, in a document, made available by the provider and notified to the user, that is easy to download, open and consult on devices commonly used by consumers. In order to facilitate choice, providers should also present a summary of the essential contract terms. In order to facilitate comparability and reduce compliance cost, the Commission should, after consulting BEREC, adopt a template for such contract summaries. The pre-contractually provided information as well as the summary template should constitute an integral part of the final contract. The contract summary should be concise and easily readable, ideally no longer than the equivalent of one single-sided A4 page or, where a number of different services are bundled into a single contract, the equivalent of up to three single-sided A4 pages. (262) Following the adoption of Regulation (EU) 2015/2120, the provisions in this Directive regarding information on conditions limiting access to, or the use of, services and applications as well as information on traffic shaping became obsolete and should be repealed. (263) With respect to terminal equipment, the customer contract should specify any conditions imposed by the provider on the use of the equipment, such as by way of \u2018SIM-locking\u2019 mobile devices, if such conditions are not prohibited under national law, and any charges due on termination of the contract, whether before or on the agreed expiry date, including any cost imposed in order to retain the equipment. Where the end-user chooses to retain terminal equipment bundled at the moment of the contract conclusion, any compensation due should not exceed its pro rata temporis value calculated on the basis of the value at the moment of the contract conclusion, or on the remaining part of the service fee until the end of the contract, whichever amount is smaller. Member States should be able to choose other methods of calculating the compensation rate, where such a rate is equal to or less than that compensation calculated. Any restriction to the usage of terminal equipment on other networks should be lifted, free of charge, by the provider at the latest upon payment of such compensation. (264) Without prejudice to the substantive obligation on the provider related to security by virtue of this Directive, the contract should specify the type of action the provider might take in the case of security incidents, threats or vulnerabilities. In addition, the contract should also specify any compensation and refund arrangements available if a provider responds inadequately to a security incident, including if a security incident, notified to the provider, takes place due to known software or hardware vulnerabilities, for which patches have been issued by the manufacturer or developer and the service provider has not applied those patches or taken any other appropriate counter-measure. (265) The availability of transparent, up-to-date and comparable information on offers and services is a key element for consumers in competitive markets where several providers offer services. End-users should be able to compare the prices of various services offered on the market easily on the basis of information published in an easily accessible form. In order to allow them to make price and service comparisons easily, competent authorities in coordination, where relevant, with national regulatory authorities should be able to require from providers of internet access services or publicly available interpersonal communication services greater transparency as regards information, including tariffs, quality of service, conditions on terminal equipment supplied, and other relevant statistics. Any such requirements should take due account of the characteristics of those networks or services. They should also ensure that third parties have the right to use, without charge, publicly available information published by such undertakings, with a view to providing comparison tools. (266) End-users are often not aware of the cost of their consumption behaviour or have difficulties in estimating their time or data consumption when using electronic communications services. In order to increase transparency and to allow for better control of their communications budget, it is important to provide end-users with facilities that enable them to track their consumption in a timely manner. In addition, Member States should be able to maintain or introduce provisions on consumption limits protecting end-users against \u2018bill-shocks\u2019, including in relation to premium rate services and other services subject to particular pricing conditions. This allows competent authorities to require information about such prices to be provided prior to providing the service and does not prejudice the possibility of Member States to maintain or introduce general obligations for premium rate services to ensure the effective protection of end-users. (267) Independent comparison tools, such as websites, are an effective means for end-users to assess the merits of different providers of internet access services and interpersonal communications services, where provided against recurring or consumption-based direct monetary payments, and to obtain impartial information, in particular by comparing prices, tariffs, and quality parameters in one place. Such tools should be operationally independent from service providers and no service provider should be given favourable treatment in search results. Such tools should aim to provide information that is both clear and concise, and complete and comprehensive. They should also aim to include the broadest possible range of offers, in order to give a representative overview and cover a significant part of the market. The information given on such tools should be trustworthy, impartial and transparent. End-users should be informed of the availability of such tools. Member States should ensure that end-users have free access to at least one such tool in their respective territories. Where there is only one tool in a Member State and that tool ceases to operate or ceases to comply with the quality criteria, the Member State should ensure that end-users have access within a reasonable time to another comparison tool at national level. (268) Independent comparison tools can be operated by private undertakings, or by or on behalf of competent authorities, however they should be operated in accordance with specified quality criteria including the requirement to provide details of their owners, provide accurate and up-to-date information, state the time of the last update, set out clear, objective criteria on which the comparison will be based, and include a broad range of offers covering a significant part of the market. Member States should be able to determine how often comparison tools are required to review and update the information they provide to end-users, taking into account the frequency with which providers of internet access services and of publicly available interpersonal communications services, generally update their tariff and quality information. (269) In order to address public interest issues with respect to the use of internet access services and publicly available number-based interpersonal communications services and to encourage protection of the rights and freedoms of others, Member States should be able to produce and disseminate or have disseminated, with the aid of providers of such services, public-interest information related to the use of such services. It should be possible for such information to include public-interest information regarding the most common infringements and their legal consequences, for instance regarding copyright infringement, other unlawful uses and the dissemination of harmful content, and advice and means of protection against risks to personal security, for example those arising from disclosure of personal information in certain circumstances, as well as risks to privacy and personal data, and the availability of easy-to-use and configurable software or software options allowing protection for children or vulnerable persons. The information could be coordinated by way of the cooperation procedure established in this Directive. Such public-interest information should be updated where necessary and should be presented in easily comprehensible formats, as determined by each Member State, and on national public authority websites. Member States should be able to oblige providers of internet access services and publicly available number-based interpersonal communications services to disseminate this standardised information to all of their customers in a manner considered to be appropriate by the national public authorities. Dissemination of such information should, however, not impose an excessive burden on providers. If it does so, Member States should require such dissemination by the means used by providers in communications with end-users made in the ordinary course of business. (270) In the absence of relevant rules of Union law, content, applications and services are considered to be lawful or harmful in accordance with national substantive and procedural law. It is a task for the Member States, not for providers of electronic communications networks or services, to decide, in accordance with due process, whether content, applications or services are lawful or harmful. This Directive and Directive 2002/58/EC are without prejudice to Directive 2000/31/EC, which, inter alia, contains a \u2018mere conduit\u2019 rule for intermediary service providers, as defined therein. (271) National regulatory authorities in coordination with other competent authorities, or where relevant, other competent authorities in co-ordination with national regulatory authorities should be empowered to monitor the quality of services and to collect systematically information on the quality of services offered by providers of internet access services and of publicly available interpersonal communications services, to the extent that the latter are able to offer minimum levels of service quality either through control of at least some elements of the network or by virtue of a service level agreement to that end, including the quality related to the provision of services to end-users with disabilities. That information should be collected on the basis of criteria which allow comparability between service providers and between Member States. Providers of such electronic communications services, operating in a competitive environment, are likely to make adequate and up-to-date information on their services publicly available for reasons of commercial advantage. National regulatory authorities in coordination with other competent authorities, or where relevant, other competent authorities in co-ordination with national regulatory authorities should nonetheless be able to require publication of such information where it is demonstrated that such information is not effectively available to the public. Where the quality of services of publicly available interpersonal communication services depends on any external factors, such as control of signal transmission or network connectivity, national regulatory authorities in coordination with other competent authorities should be able to require providers of such services to inform their consumers accordingly. (272) National regulatory authorities in coordination with other competent authorities should also set out the measurement methods to be applied by the service providers in order to improve the comparability of the data provided. In order to facilitate comparability across the Union and to reduce compliance cost, BEREC should adopt guidelines on relevant quality of service parameters which national regulatory authorities in coordination with other competent authorities should take into utmost account. (273) In order to take full advantage of the competitive environment, consumers should be able to make informed choices and to change providers when it is in their best interest to do so. It is essential to ensure that they are able to do so without being hindered by legal, technical or practical obstacles, including contractual conditions, procedures and charges. That does not preclude providers from setting reasonable minimum contractual periods of up to 24 months in consumer contracts. However, Member States should have the possibility to maintain or introduce provisions for a shorter maximum duration and to permit consumers to change tariff plans or terminate the contract within the contract period without incurring additional costs in light of national conditions, such as levels of competition and stability of network investments. Independently from the electronic communications service contract, consumers might prefer and benefit from a longer reimbursement period for physical connections. Such consumer commitments can be an important factor in facilitating deployment of very high capacity networks up to or very close to end-user premises, including through demand aggregation schemes which enable network investors to reduce initial take-up risks. However, the rights of consumers to switch between providers of electronic communications services, as established in this Directive, should not be restricted by such reimbursement periods in contracts on physical connections and such contracts should not cover terminal or internet access equipment, such as handsets, routers or modems. Member States should ensure the equal treatment of entities, including operators, financing the deployment of a very high capacity physical connection to the premises of an end-user, including where such financing is by way of an instalment contract. (274) Automatic prolongation of contracts for electronic communications services is also possible. In those cases, end-users should be able to terminate their contract without incurring any costs after the expiry of the contract term. (275) Any changes to the contractual conditions proposed by providers of publicly available electronic communications services other than number-independent interpersonal communications services, which are not to the benefit of the end-user, for example in relation to charges, tariffs, data volume limitations, data speeds, coverage, or the processing of personal data, should give rise to the right of the end-user to terminate the contract without incurring any costs, even if they are combined with some beneficial changes. Any change to the contractual conditions by the provider should therefore entitle the end-user to terminate the contract unless each change is in itself beneficial to the end-user, or the changes are of a purely administrative nature, such as a change in the provider\u2019s address, and have no negative effect on the end-user, or the changes are strictly imposed by legislative or regulatory changes, such as new contract information requirements imposed by Union or national law. Whether a change is exclusively to the benefit of the end-user should be assessed on the basis of objective criteria. The end-user\u2019s right to terminate the contract should be excluded only if the provider is able to demonstrate that all contract changes are exclusively to the benefit of the end-user or are of a purely administrative nature without any negative effect on the end-user. (276) End-users should be notified of any changes to the contractual conditions by means of a durable medium. End-users other than consumers, microenterprises or small enterprises, or not-for-profit organisations should not benefit from the termination rights in the case of contract modification, insofar as transmission services used for machine-to-machine services are concerned. Member States should be able to provide for specific end-user protections regarding contract termination where the end-users change their place of residence. The provisions on contract termination should be without prejudice to other provisions of Union or national law concerning the grounds on which contracts can be terminated or on which contractual terms and conditions can be changed by the service provider or by the end-user. (277) The possibility of switching between providers is key for effective competition in a competitive environment. The availability of transparent, accurate and timely information on switching should increase the end-users\u2019 confidence in switching and make them more willing to engage actively in the competitive process. Service providers should ensure continuity of service so that end-users are able to switch providers without being hindered by the risk of a loss of service and, where technically possible, allow for switching on the date requested by end-users. (278) Number portability is a key facilitator of consumer choice and effective competition in competitive electronic communications markets. End-users who so request should be able to retain their numbers independently of the provider of service and for a limited time between the switching of providers of service. The provision of this facility between connections to the public telephone network at fixed and non-fixed locations is not covered by this Directive. However, Member States should be able to apply provisions for porting numbers between networks providing services at a fixed location and mobile networks. (279) The impact of number portability is considerably strengthened when there is transparent tariff information, both for end-users who port their numbers and for end-users who call those who have ported their numbers. National regulatory authorities should, where feasible, facilitate appropriate tariff transparency as part of the implementation of number portability. (280) When ensuring that pricing for interconnection related to the provision of number portability is cost-oriented, national regulatory authorities should also be able to take account of prices available in comparable markets. (281) Number portability is a key facilitator of consumer choice and effective competition in competitive markets for electronic communications and should be implemented with the minimum delay, so that the number is functionally activated within one working day and the end-user does not experience a loss of service lasting longer than one working day from the agreed date. The right to port the number should be attributed to the end-user who has the relevant (pre- or post-paid) contract with the provider. In order to facilitate a one-stop-shop enabling a seamless switching experience for end- users, the switching process should be led by the receiving provider of electronic communications to the public. National regulatory or, where relevant, other competent authorities should be able to prescribe the global process of the switching and of the porting of numbers, taking into account national provisions on contracts and technological developments. This should include, where available, a requirement for the porting to be completed though over-the-air provisioning, unless an end-user requests otherwise. Experience in certain Member States has shown that there is a risk of end-users being switched to another provider without having given their consent. While that is a matter that should primarily be addressed by law enforcement authorities, Member States should be able to impose such minimum proportionate measures regarding the switching process, including appropriate penalties, as are necessary to minimise such risks, and to ensure that end-users are protected throughout the switching process without making the process less attractive for them. The right to port numbers should not be restricted by contractual conditions. (282) In order to ensure that switching and porting take place within the time-limits provided for in this Directive, Member States should provide for the compensation of end-users by providers in an easy and timely manner where an agreement between a provider and an end-user is not respected. Such measures should be proportionate to the length of the delay in complying with the agreement. End-users should at least be compensated for delays exceeding one working day in activation of service, porting of a number, or loss of service, and where providers miss agreed service or installation appointments. Additional compensation could also be in the form of an automatic reduction of the remuneration where the transferring provider is to continue providing its services until the services of the receiving provider are activated. (283) Bundles comprising at least either an internet access service or a publicly available number-based interpersonal communications service, as well as other services, such as publicly available number-independent interpersonal communications services, linear broadcasting and machine-to-machine services, or terminal equipment, have become increasingly widespread and are an important element of competition. For the purposes of this Directive, a bundle should be considered to exist in situations where the elements of the bundle are provided or sold by the same provider under the same or a closely related or linked contract. While bundles often bring about benefits for consumers, they can make switching more difficult or costly and raise risks of contractual \u2018lock-in\u2019. Where different services and terminal equipment within a bundle are subject to divergent rules on contract termination and switching or on contractual commitments regarding the acquisition of terminal equipment, consumers are effectively hampered in their rights under this Directive to switch to competitive offers for the entire bundle or parts of it. Certain essential provisions of this Directive regarding contract summary information, transparency, contract duration and termination and switching should, therefore, apply to all elements of a bundle, including terminal equipment, other services such as digital content or digital services, and electronic communications services which are not directly covered by the scope of those provisions. All end-user obligations applicable under this Directive to a given electronic communications service when provided or sold as a stand-alone service should also be applicable when it is part of a bundle with at least an internet access service or a publicly available number-based interpersonal communications service. Other contractual issues, such as the remedies applicable in the event of non-conformity with the contract, should be governed by the rules applicable to the respective element of the bundle, for instance by the rules of contracts for the sales of goods or for the supply of digital content. However, a right to terminate any element of a bundle comprising at least an internet access service or a publicly available number-based interpersonal communications service before the end of the agreed contract term because of a lack of conformity or a failure to supply should give a consumer the right to terminate all elements of the bundle. Also, in order to maintain their capacity to switch easily providers, consumers should not be locked in with a provider by means of a contractual de facto extension of the initial contract period. (284) Providers of number-based interpersonal communications services have an obligation to provide access to emergency services through emergency communications. In exceptional circumstances, namely due to a lack of technical feasibility, they might not be able to provide access to emergency services or caller location, or to both. In such cases, they should inform their customers adequately in the contract. Such providers should provide their customers with clear and transparent information in the initial contract and update it in the event of any change in the provision of access to emergency services, for example in invoices. That information should include any limitations on territorial coverage, on the basis of the planned technical operating parameters of the communications service and the available infrastructure. Where the service is not provided over a connection which is managed to give a specified quality of service, the information should also include the level of reliability of the access and of caller location information compared to a service that is provided over such a connection, taking into account current technology and quality standards, as well as any quality of service parameters specified under this Directive. (285) End-users should be able to access emergency services through emergency communications free of charge and without having to use any means of payment, from any device which enables number-based interpersonal communications services, including when using roaming services in a Member State. Emergency communications are a means of communication that includes not only voice communications services, but also SMS, messaging, video or other types of communications, for example real time text, total conversation and relay services. Member States, taking into account the capabilities and technical equipment of the PSAPs, should be able to determine which number-based interpersonal communications services are appropriate for emergency services, including the possibility to limit those options to voice communications services and their equivalent for end-users with disabilities, or to add additional options as agreed with national PSAPs. Emergency communication can be triggered on behalf of a person by an in-vehicle emergency call or an eCall as defined in Regulation (EU) 2015/758. (286) Member States should ensure that providers of number-based interpersonal communications services provide reliable and accurate access to emergency services, taking into account national specifications and criteria and the capabilities of national PSAPs. Member States should consider the PSAP\u2019s ability to handle emergency communications in more than one language. Where the number-based interpersonal communications service is not provided over a connection which is managed to give a specified quality of service, the service provider might not be able to ensure that emergency calls made through their service are routed to the most appropriate PSAP with the same reliability. For such network-independent providers, namely providers which are not integrated with a provider of public electronic communications networks, providing caller location information may not always be technically feasible. Member States should ensure that standards ensuring accurate and reliable routing and connection to the emergency services are implemented as soon as possible in order to allow network-independent providers of number-based interpersonal communications services to fulfil the obligations related to access to emergency services and caller location information provision at a level comparable to that required of other providers of such communications services. Where such standards and the related PSAP systems have not been implemented, network-independent number-based interpersonal communications services should not be required to provide access to emergency services except in a manner that is technically feasible or economically viable. This may, for example, include the designation by a Member State of a single, central PSAP for receiving emergency communications. Nonetheless, such providers should inform end-users when access to the single European emergency number \u2018112\u2019 or to caller location information is not supported. (287) In order to improve the reporting and performance measurement by Member States with respect to the answering and handling of emergency calls, the Commission should, every two years, report to the European Parliament and to the Council on the effectiveness of the implementation of the single European emergency number \u2018112\u2019. (288) Member States should take specific measures to ensure that emergency services, including the single European emergency number \u2018112\u2019, are equally accessible to end-users with disabilities, in particular deaf, hearing-impaired, speech-impaired and deaf-blind end-users and in accordance with Union law harmonising accessibility requirements for products and services. This could involve the provision of special terminal devices for end-users with disabilities when other ways of communication are not suitable for them. (289) It is important to increase awareness of the single European emergency number \u2018112\u2019 in order to improve the level of protection and security of citizens travelling in the Union. To that end, citizens should be made fully aware, when travelling in any Member State, in particular through information provided in international bus terminals, train stations, ports or airports and in telephone directories, end-user and billing material, that the single European emergency number \u2018112\u2019 can be used as a single emergency number throughout the Union. This is primarily the responsibility of the Member States, but the Commission should continue both to support and to supplement initiatives of the Member States to heighten awareness of the single European emergency number \u2018112\u2019 and periodically to evaluate the public\u2019s awareness of it. (290) Caller location information, which applies to all emergency communications, improves the level of protection and the security of end-users and assists the emergency services in the discharge of their duties, provided that the transfer of emergency communication and associated data to the emergency services concerned is guaranteed by the national system of PSAPs. The reception and use of caller location information, which includes both network-based location information and where available, enhanced handset caller location information, should comply with relevant Union law on the processing of personal data and security measures. Undertakings that provide network-based location should make caller location information available to emergency services as soon as the call reaches that service, independently of the technology used. However, handset-based location technologies have proven to be significantly more accurate and cost effective due to the availability of data provided by the European Geostationary Navigation Overlay Service and Galileo Satellite system and other Global Navigation Satellite Systems and Wi-Fi data. Therefore, handset-derived caller location information should complement network-based location information even if the handset-derived location becomes available only after the emergency communication is set up. Member States should ensure that, where available, the handset-derived caller location information is made available to the most appropriate PSAP. This might not be always possible, for example when the location is not available on the handset or through the interpersonal communications service used, or when it is not technically feasible to obtain that information. Furthermore, Member States should ensure that the PSAPs are able to retrieve and manage the caller location information available, where feasible. The establishment and transmission of caller location information should be free of charge for both the end-user and the authority handling the emergency communication irrespective of the means of establishment, for example through the handset or the network, or the means of transmission, for example through voice channel, SMS or IP-based. (291) In order to respond to technological developments concerning accurate caller location information, equivalent access for end-users with disabilities and call routing to the most appropriate PSAP, the Commission should be empowered to adopt by means of a delegated act measures necessary to ensure the compatibility, interoperability, quality, reliability and continuity of emergency communications in the Union, such as functional provisions determining the role of various parties within the communications chain, for example number-based interpersonal communications service providers, network operators and PSAPs, as well as technical provisions determining the technical means to fulfil the functional provisions. Such measures should be without prejudice to the organisation of emergency services of Member States. (292) A citizen in one Member State who needs to contact the emergency services in another Member State cannot do so because the emergency services may not have any contact information for emergency services in other Member States. A Union-wide, secure database of numbers for a lead emergency service in each country should therefore be introduced. To that end, BEREC should maintain a secure database of E.164 numbers of Member State emergency service numbers, if such a database is not maintained by another organisation, in order to ensure that the emergency services in one Member State can be contacted by the emergency services in another. (293) Diverging national law has developed in relation to the transmission by electronic communications services of public warnings regarding imminent or developing major emergencies and disasters. In order to approximate law in that area, this Directive should therefore provide that, when public warning systems are in place, public warnings should be transmitted by providers of mobile number-based interpersonal communication services to all end-users concerned. The end-users concerned should be considered to be those who are located in the geographic areas potentially being affected by imminent or developing major emergencies and disasters during the warning period, as determined by the competent authorities. (294) Where the effective reach of all end-users concerned, independently of their place or Member State of residence, is ensured and fulfils the highest level of data security, Member States should be able to provide for the transmission of public warnings by publicly available electronic communications services other than mobile number-based interpersonal communications services and other than transmission services used for broadcasting or by mobile application transmitted via internet access services. In order to inform end-users entering a Member State of the existence of such a public warning system, that Member State should ensure that those end-users receive, automatically by means of SMS, without undue delay and free of charge, easily understandable information on how to receive public warnings, including by means of mobile terminal equipment not enabled for internet access services. Public warnings other than those relying on mobile number-based interpersonal communications services should be transmitted to end-users in an easily receivable manner. Where a public warning system relies on an application, it should not require end-users to log in or register with the authorities or the application provider. End-users\u2019 location data should be used in accordance with Directive 2002/58/EC. The transmission of public warnings should be free of charge for end-users. In its review of the implementation of this Directive, the Commission could also assess whether it is possible in accordance with Union law, and feasible to set up a single Union-wide public warning system in order to alert the public in the event of an imminent or developing disaster or major state of emergency across different Member States. (295) Member States should be able to determine if proposals for alternative systems, other than through mobile number-based interpersonal communication services, are truly equivalent to such services, taking utmost account of the corresponding BEREC guidelines. Such guidelines should be developed after consulting national authorities in charge of PSAPs in order to ensure that emergency experts have a role in their development and that there is a common understanding between different Member State authorities as to what is needed to ensure full implementation of such public warning systems within the Member States while ensuring that the citizens of the Union are effectively protected while travelling in another Member State. (296) In line with the objectives of the Charter and the obligations enshrined in the United Nations Convention on the Rights of Persons with Disabilities, the regulatory framework should ensure that all end-users, including end-users with disabilities, older people, and users with special social needs, have easy and equivalent access to affordable high quality services regardless of their place of residence within the Union. Declaration 22 annexed to the final Act of Amsterdam provides that the institutions of the Union are to take account of the needs of persons with disabilities in drawing up measures under Article 114 TFEU. (297) In order to ensure that end-users with disabilities benefit from competition and the choice of service providers enjoyed by the majority of end-users, competent authorities should specify, where appropriate and in light of national conditions, and after consulting end-users with disabilities, consumer protection requirements for end-users with disabilities to be met by providers of publicly available electronic communications services. Such requirements can include, in particular, that providers ensure that end-users with disabilities take advantage of their services on equivalent terms and conditions, including prices, tariffs and quality, as those offered to their other end-users, irrespective of any additional costs incurred by those providers. Other requirements can relate to wholesale arrangements between providers. In order to avoid creating an excessive burden on service providers competent authorities should verify, whether the objectives of equivalent access and choice can be achieved without such measures. (298) In addition to Union law harmonising accessibility requirements for products and services, this Directive sets out new enhanced affordability and availability requirements on related terminal equipment and specific equipment and specific services for end-users with disabilities. Therefore, the corresponding obligation in Directive 2002/22/EC that required Member States to encourage the availability of terminal equipment for end-users with disabilities has become obsolete and should be repealed. (299) Effective competition has developed in the provision of directory enquiry services and directories pursuant, inter alia, to Article 5 of Commission Directive 2002/77/EC (39). In order to maintain that effective competition, all providers of number-based interpersonal communications services which attribute numbers from a numbering plan to their end-users should continue to be obliged to make relevant information available in a fair, cost-oriented and non-discriminatory manner. (300) End-users should be informed about their right to determine whether they want to be included in a directory. Providers of number-based interpersonal communications services should respect the end-users\u2019 decision when making data available to directory service providers. Article 12 of Directive 2002/58/EC ensures the end-users\u2019 right to privacy with regard to the inclusion of their personal information in a public directory. (301) Measures at wholesale level ensuring the inclusion of end-user data in databases should comply with the safeguards for the protection of personal data under Regulation (EU) 2016/679 and Article 12 of Directive 2002/58/EC. The cost-oriented supply of that data to service providers, with the possibility for Member States to establish a centralised mechanism for providing comprehensive aggregated information to directory providers, and the provision of network access under reasonable and transparent conditions, should be put in place in order to ensure that end-users benefit fully from competition, which has largely allowed the enabling of the removal of retail regulation from these services and the provision of offers of directory services under reasonable and transparent conditions. (302) Following the abolition of the universal service obligation for directory services and given the existence of a functioning market for such services, the right to access directory enquiry services is no longer necessary. However, the national regulatory authorities should still be able to impose obligations and conditions on undertakings that control access to end-users in order to maintain access and competition in that market. (303) End-users should be able to enjoy a guarantee of interoperability in respect of all equipment sold in the Union for the reception of radio in new vehicles of category M and of digital television. Member States should be able to require minimum harmonised standards in respect of such equipment. Such standards could be adapted from time to time in light of technological and market developments. (304) Where Member States decide to adopt measures in accordance with Directive (EU) 2015/1535 for the interoperability of consumer radio receivers, they should be capable of receiving and reproducing radio services provided via digital terrestrial radio broadcasting or via IP networks, in order to ensure that interoperability is maintained. This may also improve public safety, by enabling users to rely on a wider set of technologies for accessing and receiving emergency information in the Member States. (305) It is desirable to enable consumers to achieve the fullest connectivity possible to digital television sets. Interoperability is an evolving concept in dynamic markets. Standardisation bodies should do their utmost to ensure that appropriate standards evolve along with the technologies concerned. It is likewise important to ensure that connectors are available on digital television sets that are capable of passing all the necessary elements of a digital signal, including the audio and video streams, conditional access information, service information, API information and copy protection information. This Directive should therefore ensure that the functionality associated to or implemented in connectors is not limited by network operators, service providers or equipment manufacturers and continues to evolve in line with technological developments. For display and presentation of connected television services, the realisation of a common standard through a market-driven mechanism is recognised as a consumer benefit. Member States and the Commission should be able to take policy initiatives, consistent with the Treaties, to encourage this development. (306) The provisions on interoperability of consumer radio and television equipment do not prevent car radio receivers in new vehicles of category M from being capable of receiving and reproducing radio services provided via analogue terrestrial radio broadcasting and those provisions do not prevent Member States from imposing obligations to ensure that digital radio receivers are capable of receiving and reproducing analogue terrestrial radio broadcasts. (307) Without prejudice to Union law, this Directive does not prevent Member States from adopting technical regulations related to digital terrestrial television equipment, to prepare the migration of consumers to new terrestrial broadcasting standards, and avoid the supply of equipment that would not be compliant with the standards to be rolled out. (308) Member States should be able to lay down proportionate \u2018must carry\u2019 obligations on undertakings under their jurisdiction, in the interest of legitimate public policy considerations, but such obligations should only be imposed where they are necessary to meet general interest objectives clearly defined by Member States in accordance with Union law and should be proportionate and transparent. It should be possible to apply \u2018must carry\u2019 obligations to specified radio and television broadcast channels and complementary services supplied by a specified media service provider. Obligations imposed by Member States should be reasonable, that is they should be proportionate and transparent in light of clearly defined general interest objectives. Member States should provide an objective justification for the \u2018must carry\u2019 obligations that they impose in their national law in order to ensure that such obligations are transparent, proportionate and clearly defined. The obligations should be designed in a way which provides sufficient incentives for efficient investment in infrastructure. (309) \u2018Must carry\u2019 obligations should be subject to periodic review at least every five years in order to keep them up-to-date with technological and market evolution and in order to ensure that they continue to be proportionate to the objectives to be achieved. Such obligations could, where appropriate, entail a provision for proportionate remuneration which should be set out in national law. Where that is the case, national law should also determine the applicable methodology for calculating appropriate remuneration. That methodology should avoid inconsistency with access remedies that may be imposed by national regulatory authorities on providers of transmission services used for broadcasting which have been designated as having significant market power. However, where a fixed-term contract signed before 20 December 2018 provides for a different methodology, it should be possible to continue to apply that methodology for the duration of the contract. In the absence of a national provision on remuneration, providers of radio or television broadcast channels and providers of electronic communications networks used for the transmission of those radio or television broadcast channels should be able to agree contractually on a proportionate remuneration. (310) Electronic communications networks and services used for the distribution of radio or television broadcasts to the public include cable, IPTV, satellite and terrestrial broadcasting networks. They might also include other networks to the extent that a significant number of end-users use such networks as their principal means to receive radio and television broadcasts. \u2018Must carry\u2019 obligations related to analogue television broadcast transmissions should be considered only where the lack of such an obligation would cause significant disruption for a significant number of end-users or where there are no other means of transmission for specified television broadcast channels. \u2018Must carry\u2019 obligations can include the transmission of services specifically designed to enable equivalent access by end-users with disabilities. Accordingly complementary services include services designed to improve accessibility for end-users with disabilities, such as videotext, subtitling for end-users who are deaf or hard of hearing, audio description, spoken subtitles and sign language interpretation, and could include access to the related raw-data where necessary. In light of the growing provision and reception of connected television services and the continued importance of EPGs for end-user choice the transmission of programme-related data necessary to support connected television and EPG functionalities can be included in \u2018must carry\u2019 obligations. It should be possible for such programme-related data to include information about the programme content and how to access it, but not the programme content itself. (311) Calling line identification facilities are normally available on modern telephone exchanges and can therefore increasingly be provided at little or no expense. Member States are not required to impose obligations to provide these facilities when they are already available. Directive 2002/58/EC safeguards the privacy of users with regard to itemised billing, by giving them the means to protect their right to privacy when calling line identification is implemented. The development of those services on a pan-European basis would benefit consumers and is encouraged by this Directive. A common practice by providers of internet access services is to provide customers with an e-mail address using their commercial name or trade mark. In order to ensure end-users do not suffer lock-in effects related to the risk of losing access to e-mails when changing internet access services, Member States should be able to impose obligations on providers of such services, on request, either to provide access to their e-mails, or to transfer e-mails sent to the relevant e-mail account(s). The facility should be provided free of charge and for a duration that is considered to be appropriate by the national regulatory authority. (312) The publication of information by Member States will ensure that market players and potential market entrants understand their rights and obligations, and know where to find the relevant detailed information. Publication in the national gazette helps interested parties in other Member States to find the relevant information. (313) In order to ensure that the pan-European electronic communications market is effective and efficient, the Commission should monitor and publish information on charges which contribute to determining prices to end-users. (314) In order to determine the correct application of Union law, the Commission needs to know which undertakings have been designated as having significant market power and which obligations have been placed upon market players by national regulatory authorities. In addition to publication of that information at national level, it is therefore necessary for Member States to submit that information to the Commission. Where Member States are required to send information to the Commission, they should be able to do so by electronic means, subject to agreement on appropriate authentication procedures. (315) In order to take account of market, social and technological developments, including evolution of technical standards, to manage the risks posed to security of networks and services and to ensure effective access to emergency services through emergency communications, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting a single maximum Union-wide voice termination rate in fixed and mobile markets; adopting measures related to emergency communications in the Union; and adapting the annexes to this Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (40). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (316) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission to adopt decisions to resolve cross-border harmful interference between Member States; to identify a harmonised or coordinated approach for the purpose of addressing inconsistent implementation of general regulatory approaches by national regulatory authorities on the regulation of electronic communications markets, as well as numbering, including number ranges, portability of numbers and identifiers, number and address translation systems, and access to emergency services through the single European emergency number \u2018112\u2019; to make the implementation of standards or specifications compulsory, or remove standards or specifications from the compulsory part of the list of standards; to adopt the technical and organisational measures to appropriately manage the risks posed to security of networks and services, as well as the circumstances, format and procedures applicable to notification of security incidents; to specify relevant details relating to tradable individual rights publicly available in a standardised electronic format when the rights of use for radio spectrum are created to specify the physical and technical characteristics of small-area wireless access points; to authorise or prevent a national regulatory authority from imposing on undertakings designated as having significant market power certain obligations for access or interconnection; to harmonise specific numbers or numbering ranges to address unmet cross-border or pan-European demand for numbering resources; and to specify the contract summary template to be provided to consumers. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (41). (317) Finally, the Commission should be able to adopt, as necessary, having taken utmost account of the opinion of BEREC, recommendations in relation to the identification of the relevant product and service markets, the notifications under the procedure for consolidating the internal market and the harmonised application of the provisions of the regulatory framework. (318) The Commission should review the functioning of this Directive periodically, in particular with a view to determining the need for amendments in light of changing technological or market conditions. (319) In carrying out its review of the functioning of this Directive, the Commission should assess whether, in light of developments in the market and with regard to both competition and consumer protection, there is a continued need for the provisions on sector-specific ex ante regulation or whether those provisions should be amended or repealed. As this Directive introduces novel approaches to the regulation of electronic communications sectors, such as the possibility to extend the application of symmetric obligations beyond the first concentration or distribution point and the regulatory treatment of co-investments, a particular regard should be given in assessing their functioning. (320) Future technological and market developments, in particular changes in the use of different electronic communications services and their ability to ensure effective access to emergency services, might jeopardise the achievement of the objectives of this Directive on end-users\u2019 rights. BEREC should therefore monitor those developments in Member States and regularly publish an opinion including an assessment of the impact of such developments on the application in practice of the provisions of this Directive relating to end-users. The Commission, taking outmost account of BEREC\u2019s opinion, should publish a report and submit a legislative proposal where it considers it to be necessary to ensure that the objectives of this Directive are achieved. (321) Directives 2002/19/EC, 2002/20/EC, 2002/21/EC, 2002/22/EC and Article 5 of Decision No 243/2012/EU should be repealed. (322) The Commission should monitor the transition from the existing framework to the new framework. (323) Since the objective of this Directive, namely achieving a harmonised and simplified framework for the regulation of electronic communications networks, electronic communications services, associated facilities and associated services, of the conditions for the authorisation of networks and services, of radio spectrum use and of numbering resources, of access to and interconnection of electronic communications networks and associated facilities and of end-user protection cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (324) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (42), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (325) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to the repealed Directives. The obligation to transpose the provisions which are unchanged arises under the repealed Directives. (326) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law and the dates of application of the Directives set out in Annex XII, Part B, HAVE ADOPTED THIS DIRECTIVE: PART I FRAMEWORK (GENERAL RULES FOR THE ORGANISATION OF THE SECTOR) TITLE I SCOPE, AIM AND OBJECTIVES, DEFINITIONS CHAPTER I Subject matter, aim and definitions Article 1 Subject matter, scope and aims 1. This Directive establishes a harmonised framework for the regulation of electronic communications networks, electronic communications services, associated facilities and associated services, and certain aspects of terminal equipment. It lays down tasks of national regulatory authorities and, where applicable, of other competent authorities, and establishes a set of procedures to ensure the harmonised application of the regulatory framework throughout the Union. 2. The aims of this Directive are to: (a) implement an internal market in electronic communications networks and services that results in the deployment and take-up of very high capacity networks, sustainable competition, interoperability of electronic communications services, accessibility, security of networks and services and end-user benefits; and (b) ensure the provision throughout the Union of good quality, affordable, publicly available services through effective competition and choice, to deal with circumstances in which the needs of end-users, including those with disabilities in order to access the services on an equal basis with others, are not satisfactorily met by the market and to lay down the necessary end-user rights. 3. This Directive is without prejudice to: (a) obligations imposed by national law in accordance with Union law or by Union law in respect of services provided using electronic communications networks and services; (b) measures taken at Union or national level, in accordance with Union law, to pursue general interest objectives, in particular relating to the protection of personal data and privacy, content regulation and audiovisual policy; (c) actions taken by Member States for public order and public security purposes and for defence; (d) Regulations (EU) No 531/2012 and (EU) 2015/2120 and Directive 2014/53/EU. 4. The Commission, the Body of European Regulators for Electronic Communications (\u2018BEREC\u2019) and the authorities concerned shall ensure compliance of their processing of personal data with Union data protection rules. Article 2 Definitions For the purposes of this Directive, the following definitions apply: (1) \u2018electronic communications network\u2019 means transmission systems, whether or not based on a permanent infrastructure or centralised administration capacity, and, where applicable, switching or routing equipment and other resources, including network elements which are not active, which permit the conveyance of signals by wire, radio, optical or other electromagnetic means, including satellite networks, fixed (circuit- and packet-switched, including internet) and mobile networks, electricity cable systems, to the extent that they are used for the purpose of transmitting signals, networks used for radio and television broadcasting, and cable television networks, irrespective of the type of information conveyed; (2) \u2018very high capacity network\u2019 means either an electronic communications network which consists wholly of optical fibre elements at least up to the distribution point at the serving location, or an electronic communications network which is capable of delivering, under usual peak-time conditions, similar network performance in terms of available downlink and uplink bandwidth, resilience, error-related parameters, and latency and its variation; network performance can be considered similar regardless of whether the end-user experience varies due to the inherently different characteristics of the medium by which the network ultimately connects with the network termination point; (3) \u2018transnational markets\u2019 means markets identified in accordance with Article 65, which cover the Union or a substantial part thereof located in more than one Member State; (4) \u2018electronic communications service\u2019 means a service normally provided for remuneration via electronic communications networks, which encompasses, with the exception of services providing, or exercising editorial control over, content transmitted using electronic communications networks and services, the following types of services: (a) \u2018internet access service\u2019 as defined in point (2) of the second paragraph of Article 2 of Regulation (EU) 2015/2120; (b) interpersonal communications service; and (c) services consisting wholly or mainly in the conveyance of signals such as transmission services used for the provision of machine-to-machine services and for broadcasting; (5) \u2018interpersonal communications service\u2019 means a service normally provided for remuneration that enables direct interpersonal and interactive exchange of information via electronic communications networks between a finite number of persons, whereby the persons initiating or participating in the communication determine its recipient(s) and does not include services which enable interpersonal and interactive communication merely as a minor ancillary feature that is intrinsically linked to another service; (6) \u2018number-based interpersonal communications service\u2019 means an interpersonal communications service which connects with publicly assigned numbering resources, namely, a number or numbers in national or international numbering plans, or which enables communication with a number or numbers in national or international numbering plans; (7) \u2018number-independent interpersonal communications service\u2019 means an interpersonal communications service which does not connect with publicly assigned numbering resources, namely, a number or numbers in national or international numbering plans, or which does not enable communication with a number or numbers in national or international numbering plans; (8) \u2018public electronic communications network\u2019 means an electronic communications network used wholly or mainly for the provision of publicly available electronic communications services which support the transfer of information between network termination points; (9) \u2018network termination point\u2019 means the physical point at which an end-user is provided with access to a public electronic communications network, and which, in the case of networks involving switching or routing, is identified by means of a specific network address, which may be linked to an end-user\u2019s number or name; (10) \u2018associated facilities\u2019 means associated services, physical infrastructures and other facilities or elements associated with an electronic communications network or an electronic communications service which enable or support the provision of services via that network or service, or have the potential to do so, and include buildings or entries to buildings, building wiring, antennae, towers and other supporting constructions, ducts, conduits, masts, manholes, and cabinets; (11) \u2018associated service\u2019 means a service associated with an electronic communications network or an electronic communications service which enables or supports the provision, self-provision or automated-provision of services via that network or service, or has the potential to do so, and includes number translation or systems offering equivalent functionality, conditional access systems and electronic programme guides (EPGs), as well as other services such as identity, location and presence service; (12) \u2018conditional access system\u2019 means any technical measure, authentication system and/or arrangement whereby access to a protected radio or television broadcasting service in intelligible form is made conditional upon subscription or another form of prior individual authorisation; (13) \u2018user\u2019 means a natural or legal person using or requesting a publicly available electronic communications service; (14) \u2018end-user\u2019 means a user not providing public electronic communications networks or publicly available electronic communications services; (15) \u2018consumer\u2019 means any natural person who uses or requests a publicly available electronic communications service for purposes which are outside his or her trade, business, craft or profession; (16) \u2018provision of an electronic communications network\u2019 means the establishment, operation, control or making available of such a network; (17) \u2018enhanced digital television equipment\u2019 means set-top boxes intended for connection to television sets or integrated digital television sets, able to receive digital interactive television services; (18) \u2018application programming interface\u2019 or \u2018API\u2019 means the software interface between applications, made available by broadcasters or service providers, and the resources in the enhanced digital television equipment for digital television and radio services; (19) \u2018radio spectrum allocation\u2019 means the designation of a given radio spectrum band for use by one or more types of radio communications services, where appropriate, under specified conditions; (20) \u2018harmful interference\u2019 means interference which endangers the functioning of a radio navigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radio communications service operating in accordance with the applicable international, Union or national regulations; (21) \u2018security of networks and services\u2019 means the ability of electronic communications networks and services to resist, at a given level of confidence, any action that compromises the availability, authenticity, integrity or confidentiality of those networks and services, of stored or transmitted or processed data, or of the related services offered by, or accessible via, those electronic communications networks or services; (22) \u2018general authorisation\u2019 means a legal framework established by a Member State ensuring rights for the provision of electronic communications networks or services and laying down sector-specific obligations that may apply to all or to specific types of electronic communications networks and services, in accordance with this Directive; (23) \u2018small-area wireless access point\u2019 means low-power wireless network access equipment of a small size operating within a small range, using licenced radio spectrum or licence-exempt radio spectrum or a combination thereof, which may be used as part of a public electronic communications network, which may be equipped with one or more low visual impact antennae, and which allows wireless access by users to electronic communications networks regardless of the underlying network topology, be it mobile or fixed; (24) \u2018radio local area network\u2019 or \u2018RLAN\u2019 means low-power wireless access system, operating within a small range, with a low risk of interference with other such systems deployed in close proximity by other users, using, on a non-exclusive basis, harmonised radio spectrum; (25) \u2018harmonised radio spectrum\u2019 means radio spectrum for which harmonised conditions relating to its availability and efficient use have been established by way of technical implementing measures in accordance with Article 4 of Decision No 676/2002/EC; (26) \u2018shared use of radio spectrum\u2019 means access by two or more users to use the same radio spectrum bands under a defined sharing arrangement, authorised on the basis of a general authorisation, individual rights of use for radio spectrum or a combination thereof, including regulatory approaches such as licensed shared access aiming to facilitate the shared use of a radio spectrum band, subject to a binding agreement of all parties involved, in accordance with sharing rules as included in their rights of use for radio spectrum in order to guarantee to all users predictable and reliable sharing arrangements, and without prejudice to the application of competition law; (27) \u2018access\u2019 means the making available of facilities or services to another undertaking, under defined conditions, either on an exclusive or a non-exclusive basis, for the purpose of providing electronic communications services, including when they are used for the delivery of information society services or broadcast content services; it covers, inter alia: access to network elements and associated facilities, which may involve the connection of equipment, by fixed or non-fixed means (in particular this includes access to the local loop and to facilities and services necessary to provide services over the local loop); access to physical infrastructure including buildings, ducts and masts; access to relevant software systems including operational support systems; access to information systems or databases for pre-ordering, provisioning, ordering, maintaining and repair requests, and billing; access to number translation or systems offering equivalent functionality; access to fixed and mobile networks, in particular for roaming; access to conditional access systems for digital television services and access to virtual network services; (28) \u2018interconnection\u2019 means a specific type of access implemented between public network operators by means of the physical and logical linking of public electronic communications networks used by the same or a different undertaking in order to allow the users of one undertaking to communicate with users of the same or another undertaking, or to access services provided by another undertaking where such services are provided by the parties involved or other parties who have access to the network; (29) \u2018operator\u2019 means an undertaking providing or authorised to provide a public electronic communications network or an associated facility; (30) \u2018local loop\u2019 means the physical path used by electronic communications signals connecting the network termination point to a distribution frame or equivalent facility in the fixed public electronic communications network; (31) \u2018call\u2019 means a connection established by means of a publicly available interpersonal communications service allowing two-way voice communication; (32) \u2018voice communications service\u2019 means a publicly available electronic communications service for originating and receiving, directly or indirectly, national or national and international calls through a number or numbers in a national or international numbering plan; (33) \u2018geographic number\u2019 means a number from the national numbering plan where part of its digit structure contains geographic significance used for routing calls to the physical location of the network termination point; (34) \u2018non-geographic number\u2019 means a number from the national numbering plan that is not a geographic number, such as mobile, freephone and premium-rate numbers; (35) \u2018total conversation service\u2019 means a multimedia real time conversation service that provides bidirectional symmetric real time transfer of motion video, real time text and voice between users in two or more locations; (36) \u2018public safety answering point\u2019 or \u2018PSAP\u2019 means a physical location where an emergency communication is first received under the responsibility of a public authority or a private organisation recognised by the Member State; (37) \u2018most appropriate PSAP\u2019 means a PSAP established by responsible authorities to cover emergency communications from a certain area or for emergency communications of a certain type; (38) \u2018emergency communication\u2019 means communication by means of interpersonal communications services between an end-user and the PSAP with the goal to request and receive emergency relief from emergency services; (39) \u2018emergency service\u2019 means a service, recognised as such by the Member State, that provides immediate and rapid assistance in situations where there is, in particular, a direct risk to life or limb, to individual or public health or safety, to private or public property, or to the environment, in accordance with national law; (40) \u2018caller location information\u2019 means, in a public mobile network, the data processed, derived from network infrastructure or handsets, indicating the geographic position of an end-user\u2019s mobile terminal equipment, and, in a public fixed network, the data about the physical address of the network termination point; (41) \u2018terminal equipment\u2019 means terminal equipment as defined in point (1) of Article 1 of Commission Directive 2008/63/EC (43); (42) \u2018security incident\u2019 means an event having an actual adverse effect on the security of electronic communications networks or services. CHAPTER II Objectives Article 3 General objectives 1. Member States shall ensure that in carrying out the regulatory tasks specified in this Directive, the national regulatory and other competent authorities take all reasonable measures which are necessary and proportionate for achieving the objectives set out in paragraph 2. Member States, the Commission, the Radio Spectrum Policy Group (\u2018RSPG\u2019), and BEREC shall also contribute to the achievement of those objectives. National regulatory and other competent authorities shall contribute within their competence to ensuring the implementation of policies aimed at the promotion of freedom of expression and information, cultural and linguistic diversity, as well as media pluralism. 2. In the context of this Directive, the national regulatory and other competent authorities as well as BEREC, the Commission and the Member States shall pursue each of the following general objectives, which are not listed in order of priority: (a) promote connectivity and access to, and take-up of, very high capacity networks, including fixed, mobile and wireless networks, by all citizens and businesses of the Union; (b) promote competition in the provision of electronic communications networks and associated facilities, including efficient infrastructure-based competition, and in the provision of electronic communications services and associated services; (c) contribute to the development of the internal market by removing remaining obstacles to, and facilitating convergent conditions for, investment in, and the provision of, electronic communications networks, electronic communications services, associated facilities and associated services, throughout the Union, by developing common rules and predictable regulatory approaches, by favouring the effective, efficient and coordinated use of radio spectrum, open innovation, the establishment and development of trans-European networks, the provision, availability and interoperability of pan-European services, and end-to-end connectivity; (d) promote the interests of the citizens of the Union, by ensuring connectivity and the widespread availability and take-up of very high capacity networks, including fixed, mobile and wireless networks, and of electronic communications services, by enabling maximum benefits in terms of choice, price and quality on the basis of effective competition, by maintaining the security of networks and services, by ensuring a high and common level of protection for end-users through the necessary sector-specific rules and by addressing the needs, such as affordable prices, of specific social groups, in particular end-users with disabilities, elderly end-users and end-users with special social needs, and choice and equivalent access for end-users with disabilities. 3. Where the Commission establishes benchmarks and reports on the effectiveness of Member States\u2019 measures towards achieving the objectives referred to in paragraph 2, the Commission shall, where necessary, be assisted by Member States, national regulatory authorities, BEREC and the RSPG. 4. The national regulatory and other competent authorities shall, in pursuit of the policy objectives referred to in paragraph 2 and specified in this paragraph, inter alia: (a) promote regulatory predictability by ensuring a consistent regulatory approach over appropriate review periods and through cooperation with each other, with BEREC, with the RSPG and with the Commission; (b) ensure that, in similar circumstances, there is no discrimination in the treatment of providers of electronic communications networks and services; (c) apply Union law in a technologically neutral fashion, to the extent that this is consistent with the achievement of the objectives set out in paragraph 2; (d) promote efficient investment and innovation in new and enhanced infrastructures, including by ensuring that any access obligation takes appropriate account of the risk incurred by the investing undertakings and by permitting various cooperative arrangements between investors and parties seeking access to diversify the risk of investment, while ensuring that competition in the market and the principle of non-discrimination are preserved; (e) take due account of the variety of conditions relating to infrastructure, competition, the circumstances of end-users and, in particular, consumers in the various geographic areas within a Member State, including local infrastructure managed by natural persons on a not-for-profit basis; (f) impose ex ante regulatory obligations only to the extent necessary to secure effective and sustainable competition in the interest of end-users and relax or lift such obligations as soon as that condition is fulfilled. Member States shall ensure that the national regulatory and other competent authorities act impartially, objectively, transparently and in a non-discriminatory and proportionate manner. Article 4 Strategic planning and coordination of radio spectrum policy 1. Member States shall cooperate with each other and with the Commission in the strategic planning, coordination and harmonisation of the use of radio spectrum in the Union in accordance with Union policies for the establishment and functioning of the internal market in electronic communications. To that end, they shall take into consideration, inter alia, the economic, safety, health, public interest, freedom of expression, cultural, scientific, social and technical aspects of Union policies, as well as the various interests of radio spectrum user communities, with the aim of optimising the use of radio spectrum and avoiding harmful interference. 2. By cooperating with each other and with the Commission, Member States shall promote the coordination of radio spectrum policy approaches in the Union and, where appropriate, harmonised conditions with regard to the availability and efficient use of radio spectrum necessary for the establishment and functioning of the internal market in electronic communications. 3. Member States shall, through the RSPG, cooperate with each other and with the Commission in accordance with paragraph 1, and upon their request with the European Parliament and with the Council, in support of the strategic planning and coordination of radio spectrum policy approaches in the Union, by: (a) developing best practices on radio spectrum related matters, with a view to implementing this Directive; (b) facilitating the coordination between Member States with a view to implementing this Directive and other Union law and to contributing to the development of the internal market; (c) coordinating their approaches to the assignment and authorisation of use of radio spectrum and publishing reports or opinions on radio spectrum related matters. BEREC shall participate on issues concerning its competence relating to market regulation and competition related to radio spectrum. 4. The Commission, taking utmost account of the opinion of the RSPG, may submit legislative proposals to the European Parliament and to the Council for the purpose of establishing multiannual radio spectrum policy programmes, setting out the policy orientations and objectives for the strategic planning and harmonisation of the use of radio spectrum in accordance with this Directive, as well as for the purpose of releasing harmonised radio spectrum for shared use or for use not subject to individual rights. TITLE II INSTITUTIONAL SET-UP AND GOVERNANCE CHAPTER I National regulatory and other competent authorities Article 5 National regulatory and other competent authorities 1. Member States shall ensure that each of the tasks laid down in this Directive is undertaken by a competent authority. Within the scope of this Directive, the national regulatory authorities shall be responsible at least for the following tasks: (a) implementing ex ante market regulation, including the imposition of access and interconnection obligations; (b) ensuring the resolution of disputes between undertakings; (c) carrying out radio spectrum management and decisions or, where those tasks are assigned to other competent authorities, providing advice regarding the market-shaping and competition elements of national processes related to the rights of use for radio spectrum for electronic communications networks and services; (d) contributing to the protection of end-user rights in the electronic communications sector, in coordination, where relevant, with other competent authorities; (e) assessing and monitoring closely market-shaping and competition issues regarding open internet access; (f) assessing the unfair burden and calculating the net cost of the provision of universal service; (g) ensuring number portability between providers; (h) performing any other task that this Directive reserves to national regulatory authorities. Member States may assign other tasks provided for in this Directive and other Union law to national regulatory authorities, in particular, those related to market competition or market entry, such as general authorisation, and those related to any role conferred on BEREC. Where those tasks related to market competition or market entry are assigned to other competent authorities, they shall seek to consult the national regulatory authority before taking a decision. For the purposes of contributing to BEREC's tasks, national regulatory authorities shall be entitled to collect necessary data and other information from market participants. Member States may also assign to national regulatory authorities other tasks on the basis of national law, including national law implementing Union law. Member States shall, in particular, promote stability of competences of the national regulatory authorities when transposing this Directive with regard to the attribution of tasks resulting from the Union electronic communications regulatory framework as amended in 2009. 2. National regulatory and other competent authorities of the same Member State or of different Member States shall, where necessary, enter into cooperative arrangements with each other to foster regulatory cooperation. 3. Member States shall publish the tasks to be undertaken by national regulatory and other competent authorities in an easily accessible form, in particular where those tasks are assigned to more than one body. Member States shall ensure, where appropriate, consultation and cooperation between those authorities, and between those authorities and national authorities entrusted with the implementation of competition law or consumer law, on matters of common interest. Where more than one authority has competence to address such matters, Member States shall ensure that the respective tasks of each authority are published in an easily accessible form. 4. Member States shall notify to the Commission all national regulatory and other competent authorities that are assigned tasks under this Directive, and their respective responsibilities, as well as any change thereof. Article 6 Independence of national regulatory and other competent authorities 1. Member States shall guarantee the independence of national regulatory authorities and of other competent authorities by ensuring that they are legally distinct from, and functionally independent of, any natural or legal person providing electronic communications networks, equipment or services. Member States that retain ownership or control of undertakings providing electronic communications networks or services shall ensure effective structural separation of the regulatory function from activities associated with ownership or control. 2. Member States shall ensure that national regulatory and other competent authorities exercise their powers impartially, transparently and in a timely manner. Member States shall ensure that they have adequate technical, financial and human resources to carry out the tasks assigned to them. Article 7 Appointment and dismissal of members of national regulatory authorities 1. The head of a national regulatory authority, or, where applicable, the members of the collegiate body fulfilling that function within a national regulatory authority or their alternates, shall be appointed for a term of office of at least three years from among persons of recognised standing and professional experience, on the basis of merit, skills, knowledge and experience and following an open and transparent selection procedure. Member States shall ensure continuity of decision-making. 2. Member States shall ensure that the head of a national regulatory authority, or where applicable, members of the collegiate body fulfilling that function within a national regulatory authority or their alternates may be dismissed during their term only if they no longer fulfil the conditions required for the performance of their duties which are laid down in national law before their appointment. 3. The decision to dismiss the head of the national regulatory authority concerned, or where applicable members of the collegiate body fulfilling that function, shall be made public at the time of dismissal. The dismissed head of the national regulatory authority or, where applicable, members of the collegiate body fulfilling that function shall receive a statement of reasons. In the event that the statement of reasons is not published, it shall be published upon that person\u2019s request. Member States shall ensure that this decision is subject to review by a court, on points of fact as well as on points of law. Article 8 Political independence and accountability of the national regulatory authorities 1. Without prejudice to Article 10, national regulatory authorities shall act independently and objectively, including in the development of internal procedures and the organisation of staff, shall operate in a transparent and accountable manner in accordance with Union law, and shall not seek or take instructions from any other body in relation to the exercise of the tasks assigned to them under national law implementing Union law. This shall not prevent supervision in accordance with national constitutional law. Only appeal bodies set up in accordance with Article 31 shall have the power to suspend or overturn decisions of the national regulatory authorities. 2. National regulatory authorities shall report annually, inter alia, on the state of the electronic communications market, on the decisions they issue, on their human and financial resources and how those resources are attributed, as well as on future plans. Their reports shall be made public. Article 9 Regulatory capacity of national regulatory authorities 1. Member States shall ensure that national regulatory authorities have separate annual budgets and have autonomy in the implementation of the allocated budget. Those budgets shall be made public. 2. Without prejudice to the obligation to ensure that national regulatory authorities have adequate financial and human resources to carry out the task assigned to them, financial autonomy shall not prevent supervision or control in accordance with national constitutional law. Any control on the budget of the national regulatory authorities shall be exercised in a transparent manner and made public. 3. Member States shall also ensure that national regulatory authorities have adequate financial and human resources to enable them to actively participate in and contribute to BEREC. Article 10 Participation of national regulatory authorities in BEREC 1. Member States shall ensure that the goals of BEREC of promoting greater regulatory coordination and consistency are actively supported by their respective national regulatory authorities. 2. Member States shall ensure that national regulatory authorities take utmost account of guidelines, opinions, recommendations, common positions, best practices and methodologies adopted by BEREC when adopting their own decisions for their national markets. Article 11 Cooperation with national authorities National regulatory authorities, other competent authorities under this Directive, and national competition authorities shall provide each other with the information necessary for the application of this Directive. In respect of the information exchanged, Union data protection rules shall apply, and the receiving authority shall ensure the same level of confidentiality as that of the originating authority. CHAPTER II General authorisation Section 1 General part Article 12 General authorisation of electronic communications networks and services 1. Member States shall ensure the freedom to provide electronic communications networks and services, subject to the conditions set out in this Directive. To this end, Member States shall not prevent an undertaking from providing electronic communications networks or services, except where this is necessary for the reasons set out in Article 52(1) TFEU. Any such limitation to the freedom to provide electronic communications networks and services shall be duly reasoned and shall be notified to the Commission. 2. The provision of electronic communications networks or services, other than number-independent interpersonal communications services, may, without prejudice to the specific obligations referred to in Article 13(2) or rights of use referred to in Articles 46 and 94, be subject only to a general authorisation. 3. Where a Member State considers that a notification requirement is justified for undertakings subject to a general authorisation, that Member State may require such undertakings only to submit a notification to the national regulatory or other competent authority. The Member State shall not require such undertakings to obtain an explicit decision or any other administrative act by such authority or by any other authority before exercising the rights derived from the general authorisation. Upon notification, when required, an undertaking may start the activity, where necessary subject to the provisions on the rights of use under this Directive. 4. The notification referred to in paragraph 3 shall not entail more than a declaration by a natural or legal person to the national regulatory or other competent authority of the intention to start the provision of electronic communications networks or services and the submission of the minimal information which is required to allow BEREC and that authority to keep a register or list of providers of electronic communications networks and services. That information shall be limited to: (a) the name of the provider; (b) the provider\u2019s legal status, form and registration number, where the provider is registered in a trade or other similar public register in the Union; (c) the geographical address of the provider\u2019s main establishment in the Union, if any, and, where applicable, any secondary branch in a Member State; (d) the provider\u2019s website address, where applicable, associated with the provision of electronic communications networks or services; (e) a contact person and contact details; (f) a short description of the networks or services intended to be provided; (g) the Member States concerned; and (h) an estimated date for starting the activity. Member States shall not impose any additional or separate notification requirements. In order to approximate notification requirements, BEREC shall publish guidelines for the notification template and maintain a Union database of the notifications transmitted to the competent authorities. To that end, the competent authorities shall, by electronic means, forward each notification received to BEREC without undue delay. Notifications made to the competent authorities before 21 December 2020 shall be forwarded to BEREC by 21 December 2021. Article 13 Conditions attached to the general authorisation and to the rights of use for radio spectrum and for numbering resources, and specific obligations 1. The general authorisation for the provision of electronic communications networks or services and the rights of use for radio spectrum and rights of use for numbering resources may be subject only to the conditions listed in Annex I. Such conditions shall be non-discriminatory, proportionate and transparent. In the case of rights of use for radio spectrum, such conditions shall ensure the effective and efficient use thereof and be in accordance with Articles 45 and 51, and, in the case of rights of use for numbering resources, shall be in accordance with Article 94. 2. Specific obligations which may be imposed on undertakings providing electronic communications networks and services under Article 61(1) and (5) and Articles 62, 68 and 83 or on those designated to provide universal service under this Directive shall be legally separate from the rights and obligations under the general authorisation. In order to achieve transparency, the criteria and procedures for imposing such specific obligations on individual undertakings shall be referred to in the general authorisation. 3. The general authorisation shall contain only conditions which are specific for that sector and are set out in Parts A, B and C of Annex I and shall not duplicate conditions which are applicable to undertakings by virtue of other national law. 4. Member States shall not duplicate the conditions of the general authorisation where they grant the right of use for radio spectrum or for numbering resources. Article 14 Declarations to facilitate the exercise of rights to install facilities and rights of interconnection Competent authorities shall, within one week of the request of an undertaking, issue standardised declarations confirming, where applicable, that the undertaking has submitted a notification under Article 12(3). Those declarations shall detail the circumstances under which any undertaking providing electronic communications networks or services under the general authorisation has the right to apply for rights to install facilities, negotiate interconnection, and obtain access or interconnection, in order to facilitate the exercise of those rights, for instance at other levels of government or in relation to other undertakings. Where appropriate, such declarations may also be issued as an automatic reply following the notification referred to in Article 12(3). Section 2 General authorisation rights and obligations Article 15 Minimum list of rights derived from the general authorisation 1. Undertakings subject to the general authorisation pursuant to Article 12, shall have the right to: (a) provide electronic communications networks and services; (b) have their application for the necessary rights to install facilities considered in accordance with Article 43; (c) use, subject to Articles 13, 46 and 55, radio spectrum in relation to electronic communications networks and services; (d) have their application for the necessary rights of use for numbering resources considered in accordance with Article 94. 2. Where such undertakings provide electronic communications networks or services to the public, the general authorisation shall give them the right to: (a) negotiate interconnection with and, where applicable, obtain access to, or interconnection from, other providers of public electronic communications networks or publicly available electronic communications services covered by a general authorisation in the Union in accordance with this Directive; (b) be given an opportunity to be designated to provide different elements of the universal service or to cover different parts of the national territory in accordance with Article 86 or 87. Article 16 Administrative charges 1. Any administrative charges imposed on undertakings providing electronic communications networks or services under the general authorisation or to which a right of use has been granted shall: (a) cover, in total, only the administrative costs incurred in the management, control and enforcement of the general authorisation system and of the rights of use and of specific obligations as referred to in Article 13(2), which may include costs for international cooperation, harmonisation and standardisation, market analysis, monitoring compliance and other market control, as well as regulatory work involving preparation and enforcement of secondary legislation and administrative decisions, such as decisions on access and interconnection; and (b) be imposed upon the individual undertakings in an objective, transparent and proportionate manner which minimises additional administrative costs and associated charges. Member States may choose not to apply administrative charges to undertakings the turnover of which is below a certain threshold or the activities of which do not reach a minimum market share or have a very limited territorial scope. 2. Where national regulatory or other competent authorities impose administrative charges, they shall publish an annual overview of their administrative costs and of the total sum of the charges collected. Where there is a difference between the total sum of the charges and the administrative costs, appropriate adjustments shall be made. Article 17 Accounting separation and financial reports 1. Member States shall require undertakings providing public electronic communications networks or publicly available electronic communications services which have special or exclusive rights for the provision of services in other sectors in the same or another Member State to: (a) keep separate accounts for the activities associated with the provision of electronic communications networks or services, to the extent that would be required if those activities were carried out by legally independent entities, in order to identify all elements of cost and revenue, with the basis of their calculation and the detailed attribution methods used, related to such activities, including an itemised breakdown of fixed assets and structural costs; or (b) have structural separation for the activities associated with the provision of electronic communications networks or services. Member States may choose not to apply the requirements referred to in the first subparagraph to undertakings which have an annual turnover of less than EUR 50 million in activities associated with electronic communications networks or services in the Union. 2. Where undertakings providing public electronic communications networks or publicly available electronic communications services are not subject to the requirements of company law and do not satisfy the small and medium-sized enterprise criteria of Union law accounting rules, their financial reports shall be drawn up and submitted to independent audit and published. The audit shall be carried out in accordance with the relevant Union and national rules. The first subparagraph of this paragraph shall also apply to the separate accounts required under point (a) of the first subparagraph of paragraph 1. Section 3 Amendment and withdrawal Article 18 Amendment of rights and obligations 1. Member States shall ensure that the rights, conditions and procedures concerning general authorisations and rights of use for radio spectrum or for numbering resources or rights to install facilities may be amended only in objectively justified cases and in a proportionate manner, taking into consideration, where appropriate, the specific conditions applicable to transferable rights of use for radio spectrum or for numbering resources. 2. Except where proposed amendments are minor and have been agreed with the holder of the rights or of the general authorisation, notice shall be given in an appropriate manner of the intention to make such amendments. Interested parties, including users and consumers, shall be allowed a sufficient period of time to express their views on the proposed amendments. That period shall be no less than four weeks except in exceptional circumstances. Amendments shall be published, together with the reasons therefor. Article 19 Restriction or withdrawal of rights 1. Without prejudice to Article 30(5) and (6), Member States shall not restrict or withdraw rights to install facilities or rights of use for radio spectrum or for numbering resources before the expiry of the period for which they were granted, except where justified pursuant to paragraph 2 of this Article, and, where applicable, in accordance with Annex I, and to relevant national provisions regarding compensation for the withdrawal of rights. 2. In line with the need to ensure the effective and efficient use of radio spectrum, or the implementation of the technical implementing measures adopted under Article 4 of Decision No 676/2002/EC, Member States may allow the restriction or withdrawal of rights of use for radio spectrum, including the rights referred to in Article 49 of this Directive, based on pre-established and clearly defined procedures, in accordance with the principles of proportionality and non-discrimination. In such cases, the holders of the rights may, where appropriate and in accordance with Union law and relevant national provisions, be compensated appropriately. 3. A modification in the use of radio spectrum as a result of the application of Article 45(4) or (5) shall not alone constitute grounds to justify the withdrawal of a right of use for radio spectrum. 4. Any intention to restrict or withdraw rights under the general authorisation or individual rights of use for radio spectrum or for numbering resources without the consent of the holder of the rights shall be subject to consultation of the interested parties in accordance with Article 23. CHAPTER III Provision of information, surveys and consultation mechanism Article 20 Information request to undertakings 1. Member States shall ensure that undertakings providing electronic communications networks and services, associated facilities, or associated services, provide all the information, including financial information, necessary for national regulatory authorities, other competent authorities and BEREC to ensure conformity with the provisions of, or decisions or opinions adopted in accordance with, this Directive and Regulation (EU) 2018/1971 of the European Parliament and of the Council (44). In particular, national regulatory authorities and, where necessary for performing their tasks, other competent authorities shall have the power to require those undertakings to submit information concerning future network or service developments that could have an impact on the wholesale services that they make available to competitors, as well as information on electronic communications networks and associated facilities, which is disaggregated at local level and sufficiently detailed to enable the geographical survey and designation of areas in accordance with Article 22. Where the information collected in accordance with the first subparagraph is insufficient for national regulatory authorities, other competent authorities and BEREC to carry out their regulatory tasks under Union law, such information may be inquired from other relevant undertakings active in the electronic communications or closely related sectors. Undertakings designated as having significant market power on wholesale markets may also be required to submit accounting data on the retail markets that are associated with those wholesale markets. National regulatory and other competent authorities may request information from the single information points established pursuant to Directive 2014/61/EU. Any request for information shall be proportionate to the performance of the task and shall be reasoned. Undertakings shall provide the information requested promptly and in accordance with the timescales and level of detail required. 2. Member States shall ensure that national regulatory and other competent authorities provide the Commission, after a reasoned request, with the information necessary for it to carry out its tasks under the TFEU. The information requested by the Commission shall be proportionate to the performance of those tasks. Where the information provided refers to information previously provided by undertakings at the request of the authority, such undertakings shall be informed thereof. To the extent necessary, and unless the authority that provides the information has made an explicit and reasoned request to the contrary, the Commission shall make the information provided available to another such authority in another Member State. Subject to the requirements of paragraph 3, Member States shall ensure that the information submitted to one authority can be made available to another such authority in the same or different Member State and to BEREC, after a substantiated request, where necessary to allow either authority, or BEREC, to fulfil its responsibilities under Union law. 3. Where information gathered pursuant to paragraph 1, including information gathered in the context of a geographical survey, is considered to be confidential by a national regulatory or other competent authority in accordance with Union and national rules on commercial confidentiality, the Commission, BEREC and any other competent authorities concerned shall ensure such confidentiality. Such confidentiality shall not prevent the sharing of information between the competent authority, the Commission, BEREC and any other competent authorities concerned in a timely manner for the purposes of reviewing, monitoring and supervising the application of this Directive. 4. Member States shall ensure that, acting in accordance with national rules on public access to information and subject to Union and national rules on commercial confidentiality and protection of personal data, national regulatory and other competent authorities publish information that contributes to an open and competitive market. 5. National regulatory and other competent authorities shall publish the terms of public access to information as referred to in paragraph 4, including the procedures for obtaining such access. Article 21 Information required with regard to the general authorisation, rights of use and specific obligations 1. Without prejudice to any information requested pursuant to Article 20 and information and reporting obligations under national law other than the general authorisation, national regulatory and other competent authorities may require undertakings to provide information with regard to the general authorisation, the rights of use or the specific obligations referred to in Article 13(2), which is proportionate and objectively justified in particular for the purposes of: (a) verifying, on a systematic or case-by-case basis, compliance with condition 1 of Part A, conditions 2 and 6 of Part D, and conditions 2 and 7 of Part E, of Annex I and of compliance with obligations as referred to in Article 13(2); (b) verifying, on a case-by-case basis, compliance with conditions as set out in Annex I where a complaint has been received or where the competent authority has other reasons to believe that a condition is not complied with or in the case of an investigation by the competent authority on its own initiative; (c) carrying out procedures for and the assessment of requests for granting rights of use; (d) publishing comparative overviews of quality and price of services for the benefit of consumers; (e) collating clearly defined statistics, reports or studies; (f) carrying out market analyses for the purposes of this Directive, including data on the downstream or retail markets associated with or related to the markets which are the subject of the market analysis; (g) safeguarding the efficient use and ensuring the effective management of radio spectrum and of numbering resources; (h) evaluating future network or service developments that could have an impact on wholesale services made available to competitors, on territorial coverage, on connectivity available to end-users or on the designation of areas pursuant to Article 22; (i) conducting geographical surveys; (j) responding to reasoned requests for information by BEREC. The information referred to in points (a) and (b), and (d) to (j) of the first subparagraph shall not be required prior to, or as a condition for, market access. BEREC may develop templates for information requests, where necessary, to facilitate consolidated presentation and analysis of the information obtained. 2. As regards the rights of use for radio spectrum, the information referred to in paragraph 1 shall refer in particular to the effective and efficient use of radio spectrum as well as to compliance with any coverage and quality of service obligations attached to the rights of use for radio spectrum and their verification. 3. Where national regulatory or other competent authorities require undertakings to provide information as referred to in paragraph 1, they shall inform them of the specific purpose for which this information is to be used. 4. National regulatory or other competent authorities shall not duplicate requests of information already made by BEREC pursuant to Article 40 of Regulation (EU) 2018/1971 where BEREC has made the information received available to those authorities. Article 22 Geographical surveys of network deployments 1. National regulatory and/or other competent authorities shall conduct a geographical survey of the reach of electronic communications networks capable of delivering broadband (\u2018broadband networks\u2019) by 21 December 2023 and shall update it at least every three years thereafter. The geographical survey shall include a survey of the current geographic reach of broadband networks within their territory, as required for the tasks of national regulatory and/or other competent authorities under this Directive and for the surveys required for the application of State aid rules. The geographical survey may also include a forecast for a period determined by the relevant authority of the reach of broadband networks, including very high capacity networks, within their territory. Such forecast shall include all relevant information, including information on planned deployments by any undertaking or public authority, of very high capacity networks and significant upgrades or extensions of networks to at least 100 Mbps download speeds. For this purpose, national regulatory and/or other competent authorities shall request undertakings and public authorities to provide such information to the extent that it is available and can be provided with reasonable effort. The national regulatory authority shall decide, with respect to tasks specifically attributed to it under this Directive, the extent to which it is appropriate to rely on all or part of the information gathered in the context of such forecast. Where a geographical survey is not conducted by the national regulatory authority, it shall be done in cooperation with that authority to the extent it may be relevant for its tasks. The information collected in the geographical survey shall be at an appropriate level of local detail and shall include sufficient information on the quality of service and parameters thereof and shall be treated in accordance with Article 20(3). 2. National regulatory and/or other competent authorities may designate an area with clear territorial boundaries where, on the basis of the information gathered and any forecast prepared pursuant to paragraph 1, it is determined that, for the duration of the relevant forecast period, no undertaking or public authority has deployed or is planning to deploy a very high capacity network or significantly upgrade or extend its network to a performance of at least 100 Mbps download speeds. National regulatory and/or other competent authorities shall publish the designated areas. 3. Within a designated area, the relevant authorities may invite undertakings and public authorities to declare their intention to deploy very high capacity networks over the duration of the relevant forecast period. Where this invitation results in a declaration by an undertaking or public authority of its intention to do so, the relevant authority may require other undertakings and public authorities to declare any intention to deploy very high capacity networks, or significantly upgrade or extend its network to a performance of at least 100 Mbps download speeds in this area. The relevant authority shall specify the information to be included in such submissions, in order to ensure at least a similar level of detail as that taken into consideration in any forecast pursuant to paragraph 1. It shall also inform any undertaking or public authority expressing its interest whether the designated area is covered or likely to be covered by a next-generation access network offering download speeds below 100 Mbps on the basis of the information gathered pursuant to paragraph 1. 4. Measures pursuant to paragraph 3 shall be taken in accordance with an efficient, objective, transparent and non-discriminatory procedure, whereby no undertaking is excluded a priori. 5. Member States shall ensure that national regulatory and other competent authorities, and local, regional and national authorities with responsibility for the allocation of public funds for the deployment of electronic communications networks, for the design of national broadband plans, for defining coverage obligations attached to rights of use for radio spectrum and for verifying availability of services falling within the universal service obligations in their territory take into account the results of the geographical survey and of any designated areas pursuant to paragraphs 1, 2 and 3. Member States shall ensure that the authorities conducting the geographical survey shall supply those results subject to the receiving authority ensuring the same level of confidentiality and protection of business secrets as the originating authority and inform the parties which provided the information. Those results shall also be made available to BEREC and the Commission upon their request and under the same conditions. 6. If the relevant information is not available on the market, competent authorities shall make data from the geographical surveys which are not subject to commercial confidentiality directly accessible in accordance with Directive 2003/98/EC to allow for its reuse. They shall also, where such tools are not available on the market, make available information tools enabling end-users to determine the availability of connectivity in different areas, with a level of detail which is useful to support their choice of operator or service provider. 7. By 21 June 2020, in order to contribute to the consistent application of geographical surveys and forecasts, BEREC shall, after consulting stakeholders and in close cooperation with the Commission and relevant national authorities, issue guidelines to assist national regulatory and/or other competent authorities on the consistent implementation of their obligations under this Article. Article 23 Consultation and transparency mechanism 1. Except in cases falling within Article 26 or 27 or Article 32(10), Member States shall ensure that, where national regulatory or other competent authorities intend to take measures in accordance with this Directive, or where they intend to provide for restrictions in accordance with Article 45(4) and (5), which have a significant impact on the relevant market, they give interested parties the opportunity to comment on the draft measure within a reasonable period, having regard to the complexity of the matter and, except in exceptional circumstances, in any event not shorter than 30 days. 2. For the purposes of Article 35, the competent authorities shall inform the RSPG at the moment of publication about any draft measure which falls within the scope of the comparative or competitive selection procedure pursuant to Article 55(2) and relates to the use of radio spectrum for which harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable its use for wireless broadband electronic communications networks and services (\u2018wireless broadband networks and services\u2019). 3. National regulatory and other competent authorities shall publish their national consultation procedures. Member States shall ensure the establishment of a single information point through which all current consultations can be accessed. 4. The results of the consultation procedure shall be made publicly available, except in the case of confidential information in accordance with Union and national rules on commercial confidentiality. Article 24 Consultation of interested parties 1. Member States shall ensure, as appropriate, that competent authorities in coordination, where relevant, with national regulatory authorities take account of the views of end-users, in particular consumers, and end-users with disabilities, manufacturers and undertakings that provide electronic communications networks or services on issues related to all end-user and consumer rights, including equivalent access and choice for end-users with disabilities, concerning publicly available electronic communications services, in particular where they have a significant impact on the market. Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities establish a consultation mechanism, accessible for end-users with disabilities, ensuring that in their decisions on issues related to end-user and consumer rights concerning publicly available electronic communications services, due consideration is given to consumer interests in electronic communications. 2. Interested parties may develop, with the guidance of competent authorities in coordination, where relevant, with national regulatory authorities, mechanisms, involving consumers, user groups and service providers, to improve the general quality of service provision by, inter alia, developing and monitoring codes of conduct and operating standards. 3. Without prejudice to national rules in accordance with Union law promoting cultural and media policy objectives, such as cultural and linguistic diversity and media pluralism, competent authorities in coordination, where relevant, with national regulatory authorities may promote cooperation between undertakings providing electronic communications networks or services and sectors interested in the promotion of lawful content in electronic communications networks and services. That cooperation may also include coordination of the public-interest information to be provided pursuant to Article 103(4). Article 25 Out-of-court dispute resolution 1. Member States shall ensure that the national regulatory authority or another competent authority responsible for, or at least one independent body with proven expertise in, the application of Articles 102 to 107 and Article 115 of this Directive is listed as an alternative dispute resolution entity in accordance with Article 20(2) of Directive 2013/11/EU with a view to resolving disputes between providers and consumers arising under this Directive and relating to the performance of contracts. Member States may extend access to alternative dispute resolution procedures provided by that authority or body to end-users other than consumers, in particular microenterprises and small enterprises. 2. Without prejudice to Directive 2013/11/EU, where such disputes involve parties in different Member States, Member States shall coordinate their efforts with a view to bringing about a resolution of the dispute. Article 26 Dispute resolution between undertakings 1. In the event of a dispute arising in connection with existing obligations under this Directive between providers of electronic communications networks or services in a Member State, or between such undertakings and other undertakings in the Member State benefiting from obligations of access or interconnection or between providers of electronic communications networks or services in a Member State and providers of associated facilities, the national regulatory authority concerned shall, at the request of either party, and without prejudice to paragraph 2, issue a binding decision to resolve the dispute in the shortest possible time-frame on the basis of clear and efficient procedures, and in any case within four months except in exceptional circumstances. The Member State concerned shall require that all parties cooperate fully with the national regulatory authority. 2. Member States may make provision for national regulatory authorities to decline to resolve a dispute where other mechanisms, including mediation, exist that would better contribute to resolution of the dispute in a timely manner in accordance with the objectives set out in Article 3. The national regulatory authority shall inform the parties thereof without delay. If, after four months, the dispute is not resolved, and if the dispute has not been brought before the courts by the party seeking redress, the national regulatory authority shall issue, at the request of either party, a binding decision to resolve the dispute in the shortest possible time-frame and in any case within four months. 3. In resolving a dispute, the national regulatory authority shall take decisions aimed at achieving the objectives set out in Article 3. Any obligations imposed on an undertaking by the national regulatory authority in resolving a dispute shall comply with this Directive. 4. The decision of the national regulatory authority shall be made available to the public, having regard to the requirements of commercial confidentiality. The national regulatory authority shall provide the parties concerned with a full statement of the reasons on which the decision is based. 5. The procedure referred to in paragraphs 1, 3 and 4 shall not preclude either party from bringing an action before the courts. Article 27 Resolution of cross-border disputes 1. In the event of a dispute arising under this Directive between undertakings in different Member States, paragraphs 2, 3 and 4 of this Article shall apply. Those provisions shall not apply to disputes relating to radio spectrum coordination covered by Article 28. 2. Any party may refer the dispute to the national regulatory authority or authorities concerned. Where the dispute affects trade between Member States, the competent national regulatory authority or authorities shall notify the dispute to BEREC in order to bring about a consistent resolution of the dispute, in accordance with the objectives set out in Article 3. 3. Where such a notification has been made, BEREC shall issue an opinion inviting the national regulatory authority or authorities concerned to take specific action in order to resolve the dispute or to refrain from action, in the shortest possible time-frame, and in any case within four months except in exceptional circumstances. 4. The national regulatory authority or authorities concerned shall await BEREC's opinion before taking any action to resolve the dispute. In exceptional circumstances, where there is an urgent need to act, in order to safeguard competition or protect the interests of end-users, any of the competent national regulatory authorities may, either at the request of the parties or on its own initiative, adopt interim measures. 5. Any obligations imposed on an undertaking by the national regulatory authority as part of the resolution of the dispute shall comply with this Directive, take the utmost account of the opinion adopted by BEREC, and be adopted within one month of such opinion. 6. The procedure referred to in paragraph 2 shall not preclude either party from bringing an action before the courts. Article 28 Radio Spectrum Coordination among Member States 1. Member States and their competent authorities shall ensure that the use of radio spectrum is organised on their territory in a way that no other Member State is prevented from allowing on its territory the use of harmonised radio spectrum in accordance with Union law, especially due to cross-border harmful interference between Member States. Member States shall take all necessary measures to this effect without prejudice to their obligations under international law and relevant international agreements such as the ITU Radio Regulations and the ITU Radio Regional Agreements. 2. Member States shall cooperate with each other, and, where appropriate, through the RSPG, in the cross-border coordination of the use of radio spectrum in order to: (a) ensure compliance with paragraph 1; (b) resolve any problem or dispute in relation to cross-border coordination or cross-border harmful interference between Member States, as well as with third countries, which prevent Member States from using the harmonised radio spectrum in their territory. 3. In order to ensure compliance with paragraph 1, any affected Member State may request the RSPG to use its good offices to address any problem or dispute in relation to cross-border coordination or cross-border harmful interference. Where appropriate, the RSPG may issue an opinion proposing a coordinated solution regarding such a problem or dispute. 4. Where the actions referred to in paragraph 2 or 3 have not resolved the problem or dispute, and at the request of any affected Member State, the Commission may, taking utmost account of any opinion of the RSPG recommending a coordinated solution pursuant to paragraph 3, adopt decisions addressed to the Member States concerned by the unresolved harmful interference issue by means of implementing acts to resolve cross-border harmful interference between two or more Member States which prevent them from using the harmonised radio spectrum in their territory. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). 5. The Union shall, upon the request of any affected Member State, provide legal, political and technical support to resolve radio spectrum coordination issues with countries neighbouring the Union, including candidate and acceding countries, in such a way that the Member States concerned can observe their obligations under Union law. In the provision of such assistance, the Union shall promote the implementation of Union policies. TITLE III IMPLEMENTATION Article 29 Penalties 1. Member States shall lay down rules on penalties, including, where necessary, fines and non-criminal predetermined or periodic penalties, applicable to infringements of national provisions adopted pursuant to this Directive or of any binding decision adopted by the Commission, the national regulatory or other competent authority pursuant to this Directive, and shall take all measures necessary to ensure that they are implemented. Within the limits of national law, national regulatory and other competent authorities shall have the power to impose such penalties. The penalties provided for shall be appropriate, effective, proportionate and dissuasive. 2. Member States shall provide for penalties in the context of the procedure referred to in Article 22(3) only where an undertaking or public authority knowingly or grossly negligently provides misleading, erroneous or incomplete information. When determining the amount of fines or periodic penalties imposed on an undertaking or public authority for knowingly or grossly negligently providing misleading, erroneous or incomplete information in the context of the procedure referred to in Article 22(3), regard shall be had, inter alia, to whether the behaviour of the undertaking or public authority has had a negative impact on competition and, in particular, whether, contrary to the information originally provided or any update thereof, the undertaking or public authority either has deployed, extended or upgraded a network, or has not deployed a network and has failed to provide an objective justification for that change of plan. Article 30 Compliance with the conditions of the general authorisation or of rights of use for radio spectrum and for numbering resources and compliance with specific obligations 1. Member States shall ensure that their relevant competent authorities monitor and supervise compliance with the conditions of the general authorisation or of rights of use for radio spectrum and for numbering resources, with the specific obligations referred to in Article 13(2) and with the obligation to use radio spectrum effectively and efficiently in accordance with Article 4, Article 45(1) and Article 47. Competent authorities shall have the power to require undertakings subject to the general authorisation or benefitting from rights of use for radio spectrum or for numbering resources to provide all information necessary to verify compliance with the conditions of the general authorisation or of rights of use for radio spectrum and for numbering resources or with the specific obligations referred to in Article 13(2) or Article 47, in accordance with Article 21. 2. Where a competent authority finds that an undertaking does not comply with one or more of the conditions of the general authorisation or of rights of use for radio spectrum and for numbering resources, or with the specific obligations referred to in Article 13(2), it shall notify the undertaking of those findings and give the undertaking the opportunity to state its views, within a reasonable time limit. 3. The competent authority shall have the power to require the cessation of the breach referred to in paragraph 2 either immediately or within a reasonable time limit and shall take appropriate and proportionate measures aimed at ensuring compliance. In this regard, Member States shall empower the competent authorities to impose: (a) where appropriate, dissuasive financial penalties which may include periodic penalties with retroactive effect; and (b) orders to cease or delay provision of a service or bundle of services which, if continued, would result in significant harm to competition, pending compliance with access obligations imposed following a market analysis carried out in accordance with Article 67. The competent authorities shall communicate the measures and the reasons on which they are based to the undertaking concerned without delay and shall stipulate a reasonable period for the undertaking to comply with the measures. 4. Notwithstanding paragraphs 2 and 3 of this Article, Member States shall empower the competent authority to impose, where appropriate, financial penalties on undertakings for failure to provide information, in accordance with the obligations imposed under point (a) or (b) of the first subparagraph of Article 21(1) and Article 69, within a reasonable period set by the competent authority. 5. In the case of a serious breach or repeated breaches of the conditions of the general authorisation or of the rights of use for radio spectrum and for numbering resources, or of the specific obligations referred to in Article 13(2) or Article 47(1) or (2), where measures aimed at ensuring compliance as referred to in paragraph 3 of this Article have failed, Member States shall empower competent authorities to prevent an undertaking from continuing to provide electronic communications networks or services or suspend or withdraw those rights of use. Member States shall empower the competent authority to impose penalties which are effective, proportionate and dissuasive. Such penalties may be applied to cover the period of any breach, even if the breach has subsequently been rectified. 6. Notwithstanding paragraphs 2, 3 and 5 of this Article, the competent authority may take urgent interim measures to remedy the situation in advance of reaching a final decision, where it has evidence of a breach of the conditions of the general authorisation, of the rights of use for radio spectrum and for numbering resources, or of the specific obligations referred to in Article 13(2) or Article 47(1) or (2) which represents an immediate and serious threat to public safety, public security or public health or risks creating serious economic or operational problems for other providers or users of electronic communications networks or services or other users of the radio spectrum. The competent authority shall give the undertaking concerned a reasonable opportunity to state its views and propose any remedies. Where appropriate, the competent authority may confirm the interim measures, which shall be valid for a maximum of three months, but which may, in circumstances where enforcement procedures have not been completed, be extended for a further period of up to three months. 7. Undertakings shall have the right to appeal against measures taken under this Article in accordance with the procedure referred to in Article 31. Article 31 Right of appeal 1. Member States shall ensure that effective mechanisms exist at national level under which any user or undertaking providing electronic communications networks or services or associated facilities who is affected by a decision of a competent authority has the right of appeal against that decision to an appeal body that is independent of the parties involved and of any external intervention or political pressure liable to jeopardise its independent assessment of matters coming before it. This body, which may be a court, shall have the appropriate expertise to enable it to carry out its functions effectively. Member States shall ensure that the merits of the case are duly taken into account. Pending the outcome of the appeal, the decision of the competent authority shall stand, unless interim measures are granted in accordance with national law. 2. Where the appeal body referred to in paragraph 1 of this Article is not judicial in character, it shall always give written reasons for its decision. Furthermore, in such a case, its decision shall be subject to review by a court or a tribunal within the meaning of Article 267 TFEU. Member States shall ensure that the appeal mechanism is effective. 3. Member States shall collect information on the general subject matter of appeals, the number of requests for appeal, the duration of the appeal proceedings and the number of decisions to grant interim measures. Member States shall provide such information, as well as the decisions or judgments, to the Commission and to BEREC upon their reasoned request. TITLE IV INTERNAL MARKET PROCEDURES CHAPTER I Article 32 Consolidating the internal market for electronic communications 1. In carrying out their tasks under this Directive, national regulatory authorities shall take the utmost account of the objectives set out in Article 3. 2. National regulatory authorities shall contribute to the development of the internal market by working with each other and with the Commission and BEREC, in a transparent manner, in order to ensure the consistent application, in all Member States, of this Directive. To this end, they shall, in particular, work with the Commission and BEREC to identify the types of instruments and remedies best suited to address particular types of situations in the market. 3. Except where otherwise provided in recommendations or guidelines adopted pursuant to Article 34 upon completion of the public consultation, if required under Article 23, where a national regulatory authority intends to take a measure which: (a) falls within the scope of Article 61, 64, 67, 68 or 83; and (b) would affect trade between Member States, it shall publish the draft measure and communicate it to the Commission, to BEREC, and to the national regulatory authorities in other Member States, at the same time, stating the reasons for the measure, in accordance with Article 20(3). National regulatory authorities, BEREC and the Commission may comment on that draft measure within one month. The one-month period shall not be extended. 4. The draft measure referred to in paragraph 3 of this Article shall not be adopted for a further two months, where that measure aims to: (a) define a relevant market which is different from those defined in the recommendation referred to in Article 64(1); or (b) designate an undertaking as having, either individually or jointly with others, significant market power, under Article 67(3) or (4); and it would affect trade between Member States, and the Commission has indicated to the national regulatory authority that it considers that the draft measure would create a barrier to the internal market or if it has serious doubts as to its compatibility with Union law and in particular the objectives referred to in Article 3. That two-month period shall not be extended. The Commission shall inform BEREC and national regulatory authorities of its reservations in such a case and simultaneously make them public. 5. BEREC shall publish an opinion on the Commission\u2019s reservations referred to in paragraph 4, indicating whether it considers that the draft measure should be maintained, amended or withdrawn and shall, where appropriate, provide specific proposals to that end. 6. Within the two-month period referred to in paragraph 4, the Commission may either: (a) take a decision requiring the national regulatory authority concerned to withdraw the draft measure; or (b) take a decision to lift its reservations referred to in paragraph 4. The Commission shall take utmost account of the opinion of BEREC before taking a decision. Decisions referred to in point (a) of the first subparagraph shall be accompanied by a detailed and objective analysis of why the Commission considers that the draft measure is not to be adopted, together with specific proposals for amending it. 7. Where the Commission has adopted a decision in accordance with point (a) of the first subparagraph of paragraph 6 of this Article requiring the national regulatory authority to withdraw a draft measure, the national regulatory authority shall amend or withdraw the draft measure within six months of the date of the Commission\u2019s decision. Where the draft measure is amended, the national regulatory authority shall undertake a public consultation in accordance with Article 23, and shall notify the amended draft measure to the Commission in accordance with paragraph 3 of this Article. 8. The national regulatory authority concerned shall take the utmost account of comments of other national regulatory authorities, of BEREC and of the Commission and may, except in the cases covered by paragraph 4 and point (a) of paragraph 6, adopt the resulting draft measure and shall, where it does so, communicate it to the Commission. 9. The national regulatory authority shall communicate to the Commission and to BEREC all adopted final measures which fall under points (a) and (b) of paragraph 3. 10. In exceptional circumstances, where a national regulatory authority considers that there is an urgent need to act, in order to safeguard competition and protect the interests of users, by way of derogation from the procedure set out in paragraphs 3 and 4, it may immediately adopt proportionate and provisional measures. It shall, without delay, communicate those measures, with full reasons, to the Commission, to the other national regulatory authorities, and to BEREC. A decision of the national regulatory authority to render such measures permanent or extend the period for which they are applicable shall be subject to paragraphs 3 and 4. 11. A national regulatory authority may withdraw a draft measure at any time. Article 33 Procedure for the consistent application of remedies 1. Where an intended measure covered by Article 32(3) aims to impose, amend or withdraw an obligation on an undertaking in application of Article 61 or 67 in conjunction with Articles 69 to 76 and Article 83, the Commission may, within the one-month period referred to in Article 32(3), notify the national regulatory authority concerned and BEREC of its reasons for considering that the draft measure would create a barrier to the internal market or of its serious doubts as to its compatibility with Union law. In such a case, the draft measure shall not be adopted for a further three months following the Commission's notification. In the absence of such notification, the national regulatory authority concerned may adopt the draft measure, taking utmost account of any comments made by the Commission, BEREC or any other national regulatory authority. 2. Within the three-month period referred to in paragraph 1 of this Article, the Commission, BEREC and the national regulatory authority concerned shall cooperate closely to identify the most appropriate and effective measure in light of the objectives laid down in Article 3, whilst taking due account of the views of market participants and the need to ensure the development of consistent regulatory practice. 3. Within six weeks from the beginning of the three-month period referred to in paragraph 1, BEREC shall issue an opinion on the Commission\u2019s notification referred to in paragraph 1, indicating whether it considers that the draft measure should be amended or withdrawn and, where appropriate, provide specific proposals to that end. That opinion shall provide reasons and be made public. 4. If in its opinion, BEREC shares the serious doubts of the Commission, it shall cooperate closely with the national regulatory authority concerned to identify the most appropriate and effective measure. Before the end of the three-month period referred to in paragraph 1, the national regulatory authority may either: (a) amend or withdraw its draft measure taking utmost account of the Commission\u2019s notification referred to in paragraph 1 and of BEREC\u2019s opinion; or (b) maintain its draft measure. 5. The Commission may, within one month following the end of the three-month period referred to in paragraph 1 and taking utmost account of the opinion of BEREC, if any: (a) issue a recommendation requiring the national regulatory authority concerned to amend or withdraw the draft measure, including specific proposals to that end and providing reasons for its recommendation, in particular where BEREC does not share the Commission\u2019s serious doubts; (b) take a decision to lift its reservations indicated in accordance with paragraph 1; or (c) for draft measures falling under the second subparagraph of Article 61(3) or under Article 76(2), take a decision requiring the national regulatory authority concerned to withdraw the draft measure, where BEREC shares the serious doubts of the Commission, accompanied by a detailed and objective analysis of why the Commission considers that the draft measure should not be adopted, together with specific proposals for amending the draft measure, subject to the procedure referred to in Article 32(7), which shall apply mutatis mutandis. 6. Within one month of the Commission issuing the recommendation in accordance with point (a) of paragraph 5 or lifting its reservations in accordance with point (b) of paragraph 5, the national regulatory authority concerned shall communicate to the Commission and to BEREC the adopted final measure. That period may be extended to allow the national regulatory authority to undertake a public consultation in accordance with Article 23. 7. Where the national regulatory authority decides not to amend or withdraw the draft measure on the basis of the recommendation issued under point (a) of paragraph 5, it shall provide reasons. 8. The national regulatory authority may withdraw the proposed draft measure at any stage of the procedure. Article 34 Implementing provisions After public consultation and after consulting the national regulatory authorities and taking utmost account of the opinion of BEREC, the Commission may adopt recommendations or guidelines in relation to Article 32 that lay down the form, content and level of detail to be given in the notifications required in accordance with Article 32(3), the circumstances in which notifications would not be required, and the calculation of the time-limits. CHAPTER II Consistent radio spectrum assignment Article 35 Peer review process 1. Where the national regulatory or other competent authority intends to undertake a selection procedure in accordance with Article 55(2) in relation to radio spectrum for which harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable its use for wireless broadband networks and services, it shall, pursuant to Article 23, inform the RSPG about any draft measure which falls within the scope of the comparative or competitive selection procedure pursuant to Article 55(2) and indicate whether and when it is to request the RSPG to convene a Peer Review Forum. When requested to do so, the RSPG shall organise a Peer Review Forum in order to discuss and exchange views on the draft measures transmitted and shall facilitate the exchange of experiences and best practices on those draft measures. The Peer Review Forum shall be composed of the members of the RSPG and organised and chaired by a representative of the RSPG. 2. At the latest during the public consultation conducted pursuant to Article 23, the RSPG may exceptionally take the initiative to convene a Peer Review Forum in accordance with the rules of procedure for organising it in order to exchange experiences and best practices on a draft measure relating to a selection procedure where it considers that the draft measure would significantly prejudice the ability of the national regulatory or other competent authority to achieve the objectives set in Articles 3, 45, 46 and 47. 3. The RSPG shall define in advance and make public the objective criteria for the exceptional convening of the Peer Review Forum. 4. During the Peer Review Forum, the national regulatory authority or other competent authority shall provide an explanation on how the draft measure: (a) promotes the development of the internal market, the cross-border provision of services, as well as competition, and maximises the benefits for the consumer, and overall achieves the objectives set in Articles 3, 45, 46 and 47 of this Directive, as well as in Decisions No 676/2002/EC and No 243/2012/EU; (b) ensures effective and efficient use of radio spectrum; and (c) ensures stable and predictable investment conditions for existing and prospective radio spectrum users when deploying networks for the provision of electronic communications services which rely on radio spectrum. 5. The Peer Review Forum shall be open to voluntary participation by experts from other competent authorities and from BEREC. 6. The Peer Review Forum shall be convened only once during the overall national preparation and consultation process of a single selection procedure concerning one or several radio spectrum bands, unless the national regulatory or other competent authority requests that it is reconvened. 7. At the request of the national regulatory or other competent authority that requested the meeting, the RSPG may adopt a report on how the draft measure achieves the objectives provided in paragraph 4, reflecting the views exchanged in the Peer Review Forum. 8. The RSPG shall publish in February each year a report concerning the draft measures discussed pursuant to paragraphs 1 and 2. The report shall indicate experiences and best practices noted. 9. Following the Peer Review Forum, at the request of the national regulatory or other competent authority that requested the meeting, the RSPG may adopt an opinion on the draft measure. Article 36 Harmonised assignment of radio spectrum Where the use of radio spectrum has been harmonised, access conditions and procedures have been agreed, and undertakings to which the radio spectrum shall be assigned have been selected in accordance with international agreements and Union rules, Member States shall grant the right of use for such radio spectrum in accordance therewith. Provided that all national conditions attached to the right to use the radio spectrum concerned have been satisfied in the case of a common selection procedure, Member States shall not impose any further conditions, additional criteria or procedures which would restrict, alter or delay the correct implementation of the common assignment of such radio spectrum. Article 37 Joint authorisation process to grant individual rights of use for radio spectrum Two or several Member States may cooperate with each other and with the RSPG, taking into account any interest expressed by market participants, by jointly establishing the common aspects of an authorisation process and, where appropriate, also jointly conducting the selection process to grant individual rights of use for radio spectrum. When designing the joint authorisation process, Members States may take into consideration the following criteria: (a) the individual national authorisation processes shall be initiated and implemented by the competent authorities in accordance with a jointly agreed schedule; (b) it shall provide, where appropriate, for common conditions and procedures for the selection and granting of individual rights of use for radio spectrum among the Member States concerned; (c) it shall provide, where appropriate, for common or comparable conditions to be attached to the individual rights of use for radio spectrum among the Member States concerned, inter alia allowing users to be assigned similar radio spectrum blocks; (d) it shall be open at any time to other Member States until the joint authorisation process has been conducted. Where, in spite of the interest expressed by market participants, Member States do not act jointly, they shall inform those market participants of the reasons explaining their decision. CHAPTER III Harmonisation procedures Article 38 Harmonisation procedures 1. Where the Commission finds that divergences in the implementation by the national regulatory or other competent authorities of the regulatory tasks specified in this Directive could create a barrier to the internal market, the Commission may, taking the utmost account of the opinion of BEREC or, where relevant, the RSPG, adopt recommendations or, subject to paragraph 3 of this Article, decisions by means of implementing acts to ensure the harmonised application of this Directive and in order to further the achievement of the objectives set out in Article 3. 2. Member States shall ensure that national regulatory and other competent authorities take the utmost account of the recommendations referred to in paragraph 1 in carrying out their tasks. Where a national regulatory or other competent authority chooses not to follow a recommendation, it shall inform the Commission, giving the reasons for its position. 3. The decisions adopted pursuant to paragraph 1 shall include only the identification of a harmonised or coordinated approach for the purpose of addressing the following matters: (a) the inconsistent implementation of general regulatory approaches by national regulatory authorities on the regulation of electronic communications markets in the application of Articles 64 and 67, where it creates a barrier to the internal market; such decisions shall not refer to specific notifications issued by the national regulatory authorities pursuant to Article 32; in such a case, the Commission shall propose a draft decision only: (i) after at least two years following the adoption of a Commission recommendation dealing with the same matter; and (ii) taking utmost account of an opinion from BEREC on the case for adoption of such a decision, which shall be provided by BEREC within three months of the Commission\u2019s request; (b) numbering, including number ranges, portability of numbers and identifiers, number and address translation systems, and access to emergency services through the single European emergency number \u2018112\u2019. 4. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 118(4). 5. BEREC may, on its own initiative, advise the Commission on whether a measure should be adopted pursuant to paragraph 1. 6. If the Commission has not adopted a recommendation or a decision within one year from the date of adoption of an opinion by BEREC indicating the existence of divergences in the implementation by the national regulatory or other competent authorities of the regulatory tasks specified in this Directive that could create a barrier to the internal market, it shall inform the European Parliament and the Council of its reasons for not doing so, and make those reasons public. Where the Commission has adopted a recommendation in accordance with paragraph 1, but the inconsistent implementation creating barriers to the internal market persists for two years thereafter, the Commission shall, subject to paragraph 3, adopt a decision by means of implementing acts in accordance with paragraph 4. Where the Commission has not adopted a decision within a further year from any recommendation adopted pursuant to the second subparagraph, it shall inform the European Parliament and the Council of its reasons for not doing so, and make those reasons public. Article 39 Standardisation 1. The Commission shall draw up and publish in the Official Journal of the European Union a list of non-compulsory standards or specifications to serve as a basis for encouraging the harmonised provision of electronic communications networks, electronic communications services and associated facilities and associated services. Where necessary, the Commission may, following consultation of the Committee established by Directive (EU) 2015/1535, request that standards be drawn up by the European standardisation organisations (European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardisation (Cenelec), and European Telecommunications Standards Institute (ETSI)). 2. Member States shall encourage the use of the standards or specifications referred to in paragraph 1 for the provision of services, technical interfaces or network functions, to the extent strictly necessary to ensure interoperability of services, end-to-end connectivity, facilitation of provider switching and portability of numbers and identifiers, and to improve freedom of choice for users. In the absence of publication of standards or specifications in accordance with paragraph 1, Member States shall encourage the implementation of standards or specifications adopted by the European standardisation organisations. In the absence of such standards or specifications, Member States shall encourage the implementation of international standards or recommendations adopted by the International Telecommunication Union (ITU), the European Conference of Postal and Telecommunications Administrations (CEPT), the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC). Where international standards exist, Member States shall encourage the European standardisation organisations to use them, or the relevant parts of them, as a basis for the standards they develop, except where such international standards or relevant parts would be ineffective. Any standards or specifications referred to in paragraph 1 or in this paragraph shall not prevent access as may be required under this Directive, where feasible. 3. If the standards or specifications referred to in paragraph 1 have not been adequately implemented so that interoperability of services in one or more Member States cannot be ensured, the implementation of such standards or specifications may be made compulsory under the procedure laid down in paragraph 4, to the extent strictly necessary to ensure such interoperability and to improve freedom of choice for users. 4. Where the Commission intends to make the implementation of certain standards or specifications compulsory, it shall publish a notice in the Official Journal of the European Union and invite public comment by all parties concerned. The Commission shall, by means of implementing acts, make implementation of the relevant standards compulsory by making reference to them as compulsory standards in the list of standards or specifications published in the Official Journal of the European Union. 5. Where the Commission considers that the standards or specifications referred to in paragraph 1 no longer contribute to the provision of harmonised electronic communications services, no longer meet consumers\u2019 needs or hamper technological development, it shall remove them from the list of standards or specifications referred to in paragraph 1. 6. Where the Commission considers that the standards or specifications referred to in paragraph 4 no longer contribute to the provision of harmonised electronic communications services, no longer meet consumers\u2019 needs, or hamper technological development, it shall, by means of implementing acts, remove those standards or specifications from the list of standards or specifications referred to in paragraph 1. 7. The implementing acts referred to in paragraphs 4 and 6 of this Article shall be adopted in accordance with the examination procedure referred to in Article 118(4). 8. This Article does not apply in respect of any of the essential requirements, interface specifications or harmonised standards to which Directive 2014/53/EU applies. TITLE V SECURITY Article 40 Security of networks and services 1. Member States shall ensure that providers of public electronic communications networks or of publicly available electronic communications services take appropriate and proportionate technical and organisational measures to appropriately manage the risks posed to the security of networks and services. Having regard to the state of the art, those measures shall ensure a level of security appropriate to the risk presented. In particular, measures, including encryption where appropriate, shall be taken to prevent and minimise the impact of security incidents on users and on other networks and services. The European Union Agency for Network and Information Security (\u2018ENISA\u2019) shall facilitate, in accordance with Regulation (EU) No 526/2013 of the European Parliament and of the Council (45), the coordination of Member States to avoid diverging national requirements that may create security risks and barriers to the internal market. 2. Member States shall ensure that providers of public electronic communications networks or of publicly available electronic communications services notify without undue delay the competent authority of a security incident that has had a significant impact on the operation of networks or services. In order to determine the significance of the impact of a security incident, where available the following parameters shall, in particular, be taken into account: (a) the number of users affected by the security incident; (b) the duration of the security incident; (c) the geographical spread of the area affected by the security incident; (d) the extent to which the functioning of the network or service is affected; (e) the extent of impact on economic and societal activities. Where appropriate, the competent authority concerned shall inform the competent authorities in other Member States and ENISA. The competent authority concerned may inform the public or require the providers to do so, where it determines that disclosure of the security incident is in the public interest. Once a year, the competent authority concerned shall submit a summary report to the Commission and to ENISA on the notifications received and the action taken in accordance with this paragraph. 3. Member States shall ensure that in the case of a particular and significant threat of a security incident in public electronic communications networks or publicly available electronic communications services, providers of such networks or services shall inform their users potentially affected by such a threat of any possible protective measures or remedies which can be taken by the users. Where appropriate, providers shall also inform their users of the threat itself. 4. This Article is without prejudice to Regulation (EU) 2016/679 and Directive 2002/58/EC. 5. The Commission, taking utmost account of ENISA\u2019s opinion, may adopt implementing acts detailing the technical and organisational measures referred to in paragraph 1, as well as the circumstances, format and procedures applicable to notification requirements pursuant to paragraph 2. They shall be based on European and international standards to the greatest extent possible, and shall not prevent Member States from adopting additional requirements in order to pursue the objectives set out in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). Article 41 Implementation and enforcement 1. Member States shall ensure that, in order to implement Article 40, the competent authorities have the power to issue binding instructions, including those regarding the measures required to remedy a security incident or prevent one from occurring when a significant threat has been identified and time-limits for implementation, to providers of public electronic communications networks or publicly available electronic communications services. 2. Member States shall ensure that competent authorities have the power to require providers of public electronic communications networks or publicly available electronic communications services to: (a) provide information needed to assess the security of their networks and services, including documented security policies; and (b) submit to a security audit carried out by a qualified independent body or a competent authority and make the results thereof available to the competent authority; the cost of the audit shall be paid by the provider. 3. Member States shall ensure that the competent authorities have all the powers necessary to investigate cases of non-compliance and the effects thereof on the security of the networks and services. 4. Member States shall ensure that, in order to implement Article 40, the competent authorities have the power to obtain the assistance of a Computer Security Incident Response Team (\u2018CSIRT\u2019) designated pursuant to Article 9 of Directive (EU) 2016/1148 in relation to issues falling within the tasks of the CSIRTs pursuant to point 2 of Annex I to that Directive. 5. The competent authorities shall, where appropriate and in accordance with national law, consult and cooperate with the relevant national law enforcement authorities, the competent authorities within the meaning of Article 8(1) of Directive (EU) 2016/1148 and the national data protection authorities. PART II NETWORKS TITLE I MARKET ENTRY AND DEPLOYMENT CHAPTER I Fees Article 42 Fees for rights of use for radio spectrum and rights to install facilities 1. Member States may allow the competent authority to impose fees for the rights of use for radio spectrum or rights to install facilities on, over or under public or private property that are used for the provision of electronic communications networks or services and associated facilities which ensure the optimal use of those resources. Member States shall ensure that such fees are objectively justified, transparent, non-discriminatory and proportionate in relation to their intended purpose and shall take into account the general objectives of this Directive. 2. With respect to rights of use for radio spectrum, Member States shall seek to ensure that applicable fees are set at a level which ensures efficient assignment and use of radio spectrum, including by: (a) setting reserve prices as minimum fees for rights of use for radio spectrum by having regard to the value of those rights in their possible alternative uses; (b) taking into account costs entailed by conditions attached to those rights; and (c) applying, to the extent possible, payment arrangements linked to the actual availability for use of the radio spectrum. CHAPTER II Access to land Article 43 Rights of way 1. Member States shall ensure that, when a competent authority considers an application for the granting of rights: \u2014 to install facilities on, over or under public or private property to an undertaking authorised to provide public electronic communications networks, or \u2014 to install facilities on, over or under public property to an undertaking authorised to provide electronic communications networks other than to the public, that competent authority: (a) acts on the basis of simple, efficient, transparent and publicly available procedures, applied without discrimination and without delay, and in any event makes its decision within six months of the application, except in the case of expropriation; and (b) follows the principles of transparency and non-discrimination in attaching conditions to any such rights. The procedures referred to in points (a) and (b) may differ depending on whether the applicant is providing public electronic communications networks or not. 2. Member States shall ensure that, where public or local authorities retain ownership or control of undertakings providing public electronic communications networks or publicly available electronic communications services, there is an effective structural separation of the function responsible for granting the rights referred to in paragraph 1 from the activities associated with ownership or control. Article 44 Co-location and sharing of network elements and associated facilities for providers of electronic communications networks 1. Where an operator has exercised the right under national law to install facilities on, over or under public or private property, or has taken advantage of a procedure for the expropriation or use of property, competent authorities may impose co-location and sharing of the network elements and associated facilities installed on that basis, in order to protect the environment, public health, public security or to meet town- and country-planning objectives. Co-location or sharing of network elements and facilities installed and sharing of property may be imposed only after an appropriate period of public consultation, during which all interested parties shall be given an opportunity to express their views and only in the specific areas where such sharing is considered to be necessary with a view to pursuing the objectives provided in the first subparagraph. Competent authorities may impose the sharing of such facilities or property, including land, buildings, entries to buildings, building wiring, masts, antennae, towers and other supporting constructions, ducts, conduits, manholes, cabinets or measures facilitating the coordination of public works. Where necessary, a Member State may designate a national regulatory or other competent authority for one or more of the following tasks: (a) coordinating the process provided for in this Article; (b) acting as a single information point; (c) setting down rules for apportioning the costs of facility or property sharing and of civil works coordination. 2. Measures taken by a competent authority in accordance with this Article shall be objective, transparent, non-discriminatory, and proportionate. Where relevant, these measures shall be carried out in coordination with the national regulatory authorities. CHAPTER III Access to radio spectrum Section 1 Authorisations Article 45 Management of radio spectrum 1. Taking due account of the fact that radio spectrum is a public good that has an important social, cultural and economic value, Member States shall ensure the effective management of radio spectrum for electronic communications networks and services in their territory in accordance with Articles 3 and 4. They shall ensure that the allocation of, the issuing of general authorisations in respect of, and the granting of individual rights of use for radio spectrum for electronic communications networks and services by competent authorities are based on objective, transparent, pro-competitive, non-discriminatory and proportionate criteria. In applying this Article, Member States shall respect relevant international agreements, including the ITU Radio Regulations and other agreements adopted in the framework of the ITU applicable to radio spectrum, such as the agreement reached at the Regional Radiocommunications Conference of 2006, and may take public policy considerations into account. 2. Member States shall promote the harmonisation of use of radio spectrum by electronic communications networks and services across the Union, consistent with the need to ensure effective and efficient use thereof and in pursuit of benefits for the consumer such as competition, economies of scale and interoperability of networks and services. In so doing, they shall act in accordance with Article 4 of this Directive and with Decision No 676/2002/EC, inter alia, by: (a) pursuing wireless broadband coverage of their national territory and population at high quality and speed, as well as coverage of major national and European transport paths, including trans-European transport network as referred to in Regulation (EU) No 1315/2013 of the European Parliament and of the Council (46); (b) facilitating the rapid development in the Union of new wireless communications technologies and applications, including, where appropriate, in a cross-sectoral approach; (c) ensuring predictability and consistency in the granting, renewal, amendment, restriction and withdrawal of rights of use for radio spectrum in order to promote long-term investments; (d) ensuring the prevention of cross-border or national harmful interference in accordance with Articles 28 and 46 respectively, and taking appropriate pre-emptive and remedial measures to that end; (e) promoting the shared use of radio spectrum between similar or different uses of radio spectrum in accordance with competition law; (f) applying the most appropriate and least onerous authorisation system possible in accordance with Article 46 in such a way as to maximise flexibility, sharing and efficiency in the use of radio spectrum; (g) applying rules for the granting, transfer, renewal, modification and withdrawal of rights of use for radio spectrum that are clearly and transparently laid down in order to guarantee regulatory certainty, consistency and predictability; (h) pursuing consistency and predictability throughout the Union regarding the way the use of radio spectrum is authorised in protecting public health taking into account Recommendation 1999/519/EC. For the purpose of the first subparagraph, and in the context of the development of technical implementing measures for a radio spectrum band under Decision No 676/2002/EC, the Commission may request the RSPG to issue an opinion recommending the most appropriate authorisation regimes for the use of radio spectrum in that band or parts thereof. Where appropriate and taking utmost account of such opinion, the Commission may adopt a recommendation with a view to promoting a consistent approach in the Union with regard to the authorisation regimes for the use of that band. Where the Commission is considering the adoption of measures in accordance with Article 39(1), (4), (5) and (6), it may request the opinion of the RSPG with regard to the implications of any such standard or specification for the coordination, harmonisation and availability of radio spectrum. The Commission shall take utmost account of the RSPG\u2019s opinion in taking any subsequent steps. 3. In the case of a national or regional lack of market demand for the use of a band in the harmonised radio spectrum, Member States may allow an alternative use of all or part of that band, including the existing use, in accordance with paragraphs 4 and 5 of this Article, provided that: (a) the finding of a lack of market demand for the use of such a band is based on a public consultation in accordance with Article 23, including a forward-looking assessment of market demand; (b) such alternative use does not prevent or hinder the availability or the use of such a band in other Member States; and (c) the Member State concerned takes due account of the long-term availability or use of such a band in the Union and the economies of scale for equipment resulting from using the harmonised radio spectrum in the Union. Any decision to allow alternative use on an exceptional basis shall be subject to a regular review and shall in any event be reviewed promptly upon a duly justified request by a prospective user to the competent authority for use of the band in accordance with the technical implementing measure. The Member State shall inform the Commission and the other Member States of the decision taken, together with the reasons therefor, as well as of the outcome of any review. 4. Without prejudice to the second subparagraph, Member States shall ensure that all types of technology used for the provision of electronic communications networks or services may be used in the radio spectrum declared available for electronic communications services in their National Frequency Allocation Plan in accordance with Union law. Member States may, however, provide for proportionate and non-discriminatory restrictions to the types of radio network or wireless access technology used for electronic communications services where this is necessary to: (a) avoid harmful interference; (b) protect public health against electromagnetic fields, taking utmost account of Recommendation 1999/519/EC; (c) ensure technical quality of service; (d) ensure maximisation of radio spectrum sharing; (e) safeguard efficient use of radio spectrum; or (f) ensure the fulfilment of a general interest objective in accordance with paragraph 5. 5. Without prejudice to the second subparagraph, Member States shall ensure that all types of electronic communications services may be provided in the radio spectrum declared available for electronic communications services in their National Frequency Allocation Plan in accordance with Union law. Member States may, however, provide for proportionate and non-discriminatory restrictions to the types of electronic communications services to be provided, including, where necessary, to fulfil a requirement under the ITU Radio Regulations. Measures that require an electronic communications service to be provided in a specific band available for electronic communications services shall be justified in order to ensure the fulfilment of a general interest objective as laid down by the Member States in accordance with Union law, including, but not limited to: (a) safety of life; (b) the promotion of social, regional or territorial cohesion; (c) the avoidance of inefficient use of radio spectrum; or (d) the promotion of cultural and linguistic diversity and media pluralism, for example the provision of radio and television broadcasting services. A measure which prohibits the provision of any other electronic communications service in a specific band may be provided for only where justified by the need to protect the safety of life services. Member States may, on an exceptional basis, also extend such a measure in order to fulfil other general interest objectives as laid down by the Member States in accordance with Union law. 6. Member States shall regularly review the necessity of the restrictions referred to in paragraphs 4 and 5, and shall make the results of those reviews public. 7. Restrictions established prior to 25 May 2011 shall comply with paragraphs 4 and 5 by 20 December 2018. Article 46 Authorisation of the use of radio spectrum 1. Member States shall facilitate the use of radio spectrum, including shared use, under general authorisations and limit the granting of individual rights of use for radio spectrum to situations where such rights are necessary to maximise efficient use in light of demand and taking into account the criteria set out in the second subparagraph. In all other cases, they shall set out the conditions for the use of radio spectrum in a general authorisation. To that end, Member States shall decide on the most appropriate regime for authorising the use of radio spectrum, taking account of: (a) the specific characteristics of the radio spectrum concerned; (b) the need to protect against harmful interference; (c) the development of reliable conditions for radio spectrum sharing, where appropriate; (d) the need to ensure technical quality of communications or service; (e) objectives of general interest as laid down by Member States in accordance with Union law; (f) the need to safeguard efficient use of radio spectrum. When considering whether to issue general authorisations or to grant individual rights of use for the harmonised radio spectrum, taking into account technical implementing measures adopted in accordance with Article 4 of Decision No 676/2002/EC, Member States shall seek to minimise problems of harmful interference, including in cases of shared use of radio spectrum on the basis of a combination of general authorisation and individual rights of use. Where appropriate, Member States shall consider the possibility to authorise the use of radio spectrum based on a combination of general authorisation and individual rights of use, taking into account the likely effects of different combinations of general authorisations and individual rights of use and of gradual transfers from one category to the other on competition, innovation and market entry. Member States shall seek to minimise restrictions on the use of radio spectrum by taking appropriate account of technological solutions for managing harmful interference in order to impose the least onerous authorisation regime possible. 2. When taking a decision pursuant to paragraph 1 with a view to facilitating the shared use of radio spectrum, the competent authorities shall ensure that the conditions for the shared use of radio spectrum are clearly set out. Such conditions shall facilitate efficient use of radio spectrum, competition and innovation. Article 47 Conditions attached to individual rights of use for radio spectrum 1. Competent authorities shall attach conditions to individual rights of use for radio spectrum in accordance with Article 13(1) in such a way as to ensure optimal and the most effective and efficient use of radio spectrum. They shall, before the assignment or renewal of such rights, clearly establish any such conditions, including the level of use required and the possibility to fulfil that requirement through trading or leasing, in order to ensure the implementation of those conditions in accordance with Article 30. Conditions attached to renewals of right of use for radio spectrum shall not provide undue advantages to existing holders of those rights. Such conditions shall specify the applicable parameters, including any deadline for exercising the rights of use, the non-fulfilment of which would entitle the competent authority to withdraw the right of use or impose other measures. Competent authorities shall, in a timely and transparent manner, consult and inform interested parties regarding conditions attached to individual rights of use before their imposition. They shall determine in advance and inform interested parties, in a transparent manner, of the criteria for the assessment of the fulfilment of those conditions. 2. When attaching conditions to individual rights of use for radio spectrum, competent authorities may, in particular with a view to ensuring effective and efficient use of radio spectrum or promoting coverage, provide for the following possibilities: (a) sharing passive or active infrastructure which relies on radio spectrum or radio spectrum; (b) commercial roaming access agreements; (c) joint roll-out of infrastructures for the provision of networks or services which rely on the use of radio spectrum. Competent authorities shall not prevent the sharing of radio spectrum in the conditions attached to the rights of use for radio spectrum. Implementation by undertakings of conditions attached pursuant to this paragraph shall remain subject to competition law. Section 2 Rights of use Article 48 Granting of individual rights of use for radio spectrum 1. Where it is necessary to grant individual rights of use for radio spectrum, Member States shall grant such rights, upon request, to any undertaking for the provision of electronic communications networks or services under the general authorisation referred to in Article 12, subject to Article 13, to point (c) of Article 21(1) and to Article 55 and to any other rules ensuring the efficient use of those resources in accordance with this Directive. 2. Without prejudice to specific criteria and procedures adopted by Member States to grant individual rights of use for radio spectrum to providers of radio or television broadcast content services with a view to pursuing general interest objectives in accordance with Union law, the individual rights of use for radio spectrum shall be granted through open, objective, transparent, non-discriminatory and proportionate procedures, and in accordance with Article 45. 3. An exception to the requirement of open procedures may apply where the granting of individual rights of use for radio spectrum to the providers of radio or television broadcast content services is necessary to achieve a general interest objective as laid down by Member States in accordance with Union law. 4. Competent authorities shall consider applications for individual rights of use for radio spectrum in the context of selection procedures pursuant to objective, transparent, proportionate and non-discriminatory eligibility criteria that are set out in advance and reflect the conditions to be attached to such rights. Competent authorities shall be able to request all necessary information from applicants in order to assess, on the basis of those criteria, their ability to comply with those conditions. Where the competent authority concludes that an applicant does not possess the required ability, it shall provide a duly reasoned decision to that effect. 5. When granting individual rights of use for radio spectrum, Member States shall specify whether those rights can be transferred or leased by the holder of the rights, and under which conditions. Articles 45 and 51 shall apply. 6. The competent authority shall take, communicate and make public the decisions on the granting of individual rights of use for radio spectrum as soon as possible after the receipt of the complete application and within six weeks in the case of radio spectrum declared available for electronic communications services in their National Frequency Allocation Plan. That time limit shall be without prejudice to Article 55(7) and to any applicable international agreements relating to the use of radio spectrum or of orbital positions. Article 49 Duration of rights 1. Where Member States authorise the use of radio spectrum through individual rights of use for a limited period, they shall ensure that the right of use is granted for a period that is appropriate in light of the objectives pursued in accordance with Article 55(2), taking due account of the need to ensure competition, as well as, in particular, effective and efficient use of radio spectrum, and to promote innovation and efficient investments, including by allowing for an appropriate period for investment amortisation. 2. Where Member States grant individual rights of use for radio spectrum for which harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable its use for wireless broadband electronic communications services (\u2018wireless broadband services\u2019) for a limited period, they shall ensure regulatory predictability for the holders of the rights over a period of at least 20 years regarding conditions for investment in infrastructure which relies on the use of such radio spectrum, taking account of the requirements referred to in paragraph 1 of this Article. This Article is subject, where relevant, to any modification of the conditions attached to those rights of use in accordance with Article 18. To that end, Member States shall ensure that such rights are valid for a duration of at least 15 years and include, where necessary to comply with the first subparagraph, an adequate extension thereof, under the conditions laid down in this paragraph. Member States shall make available the general criteria for an extension of the duration of rights of use, in a transparent manner, to all interested parties in advance of granting rights of use, as part of the conditions laid down under Article 55(3) and (6). Such general criteria shall relate to: (a) the need to ensure the effective and efficient use of the radio spectrum concerned, the objectives pursued in points (a) and (b) of Article 45(2), or the need to fulfil general interest objectives related to ensuring safety of life, public order, public security or defence; and (b) the need to ensure undistorted competition. At the latest two years before the expiry of the initial duration of an individual right of use, the competent authority shall conduct an objective and forward-looking assessment of the general criteria laid down for extension of the duration of that right of use in light of point (c) of Article 45(2). Provided that the competent authority has not initiated enforcement action for non-compliance with the conditions of the rights of use pursuant to Article 30, it shall grant the extension of the duration of the right of use unless it concludes that such an extension would not comply with the general criteria laid down in point (a) or (b) of the third subparagraph of this paragraph. On the basis of that assessment, the competent authority shall notify the holder of the right as to whether the extension of the duration of the right of use is to be granted. If such extension is not to be granted, the competent authority shall apply Article 48 for granting rights of use for that specific radio spectrum band. Any measure under this paragraph shall be proportionate, non-discriminatory, transparent and reasoned. By way of derogation from Article 23, interested parties shall have the opportunity to comment on any draft measure pursuant to the third and the fourth subparagraphs of this paragraph for a period of at least three months. This paragraph is without prejudice to the application of Articles 19 and 30. When establishing fees for rights of use, Member States shall take account of the mechanism provided for under this paragraph. 3. Where duly justified, Member States may derogate from paragraph 2 of this Article in the following cases: (a) in limited geographical areas, where access to high-speed networks is severely deficient or absent and this is necessary to ensure achievement of the objectives of Article 45(2); (b) for specific short-term projects; (c) for experimental use; (d) for uses of radio spectrum which, in accordance with Article 45(4) and (5), can coexist with wireless broadband services; or (e) for alternative use of radio spectrum in accordance with Article 45(3). 4. Member States may adjust the duration of rights of use laid down in this Article to ensure the simultaneous expiry of the duration of rights in one or several bands. Article 50 Renewal of individual rights of use for harmonised radio spectrum 1. National regulatory or other competent authorities shall take a decision on the renewal of individual rights of use for harmonised radio spectrum in a timely manner before the duration of those rights expired, except where, at the time of assignment, the possibility of renewal has been explicitly excluded. For that purpose, those authorities shall assess the need for such renewal at their own initiative or upon request by the holder of the right, in the latter case not earlier than five years prior to expiry of the duration of the rights concerned. This shall be without prejudice to renewal clauses applicable to existing rights. 2. In taking a decision pursuant to paragraph 1 of this Article, competent authorities shall consider, inter alia: (a) the fulfilment of the objectives set out in Article 3, Article 45(2) and Article 48(2), as well as public policy objectives under Union or national law; (b) the implementation of a technical implementing measure adopted in accordance with Article 4 of Decision No 676/2002/EC; (c) the review of the appropriate implementation of the conditions attached to the right concerned; (d) the need to promote, or avoid any distortion of, competition in line with Article 52; (e) the need to render the use of radio spectrum more efficient in light of technological or market evolution; (f) the need to avoid severe service disruption. 3. When considering possible renewal of individual rights of use for harmonised radio spectrum for which the number of rights of use is limited pursuant to paragraph 2 of this Article, competent authorities shall conduct an open, transparent and non-discriminatory procedure, and shall, inter alia: (a) give all interested parties the opportunity to express their views through a public consultation in accordance with Article 23; and (b) clearly state the reasons for such possible renewal. The national regulatory or other competent authority shall take into account any evidence arising from the consultation pursuant to the first subparagraph of this paragraph of market demand from undertakings other than those holding rights of use for radio spectrum in the band concerned when deciding whether to renew the rights of use or to organise a new selection procedure in order to grant the rights of use pursuant to Article 55. 4. A decision to renew the individual rights of use for harmonised radio spectrum may be accompanied by a review of the fees as well as of the other terms and conditions attached thereto. Where appropriate, national regulatory or other competent authorities may adjust the fees for the rights of use in accordance with Article 42. Article 51 Transfer or lease of individual rights of use for radio spectrum 1. Member States shall ensure that undertakings may transfer or lease to other undertakings individual rights of use for radio spectrum. Member States may determine that this paragraph does not apply where the undertaking\u2019s individual right of use for radio spectrum was initially granted free of charge or assigned for broadcasting. 2. Member States shall ensure that an undertaking\u2019s intention to transfer or lease rights of use for radio spectrum, as well as the effective transfer thereof is notified in accordance with national procedures to the competent authority and is made public. In the case of harmonised radio spectrum, any such transfer shall comply with such harmonised use. 3. Member States shall allow the transfer or lease of rights of use for radio spectrum where the original conditions attached to the rights of use are maintained. Without prejudice to the need to ensure the absence of a distortion of competition, in particular in accordance with Article 52, Member States shall: (a) submit transfers and leases to the least onerous procedure possible; (b) not refuse the lease of rights of use for radio spectrum where the lessor undertakes to remain liable for meeting the original conditions attached to the rights of use; (c) not refuse the transfer of rights of use for radio spectrum unless there is a clear risk that the new holder is unable to meet the original conditions for the right of use. Any administrative charge imposed on undertakings in connection with processing an application for the transfer or lease of rights of use for radio spectrum shall comply with Article 16. Points (a), (b) and (c) of the first subparagraph are without prejudice to the Member States\u2019 competence to enforce compliance with the conditions attached to the rights of use at any time, both with regard to the lessor and the lessee, in accordance with their national law. Competent authorities shall facilitate the transfer or lease of rights of use for radio spectrum by giving consideration to any request to adapt the conditions attached to the rights in a timely manner and by ensuring that those rights or the relevant radio spectrum may to the best extent be partitioned or disaggregated. In light of any transfer or lease of rights of use for radio spectrum, competent authorities shall make relevant details relating to tradable individual rights publicly available in a standardised electronic format when the rights are created and keep those details for as long as the rights exist. The Commission may adopt implementing acts specifying those relevant details. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). Article 52 Competition 1. National regulatory and other competent authorities shall promote effective competition and avoid distortions of competition in the internal market when deciding to grant, amend or renew rights of use for radio spectrum for electronic communications networks and services in accordance with this Directive. 2. When Member States grant, amend or renew rights of use for radio spectrum, their national regulatory or other competent authorities upon the advice provided by national regulatory authority may take appropriate measures such as: (a) limiting the amount of radio spectrum bands for which rights of use are granted to any undertaking, or, in justified circumstances, attaching conditions to such rights of use, such as the provision of wholesale access, national or regional roaming, in certain bands or in certain groups of bands with similar characteristics; (b) reserving, if appropriate and justified with regard to a specific situation in the national market, a certain part of a radio spectrum band or group of bands for assignment to new entrants; (c) refusing to grant new rights of use for radio spectrum or to allow new radio spectrum uses in certain bands, or attaching conditions to the grant of new rights of use for radio spectrum or to the authorisation of new uses of radio spectrum, in order to avoid the distortion of competition by any assignment, transfer or accumulation of rights of use; (d) including conditions prohibiting, or imposing conditions on, transfers of rights of use for radio spectrum, not subject to Union or national merger control, where such transfers are likely to result in significant harm to competition; (e) amending the existing rights in accordance with this Directive where this is necessary to remedy ex post a distortion of competition by any transfer or accumulation of rights of use for radio spectrum. National regulatory and other competent authorities shall, taking into account market conditions and available benchmarks, base their decisions on an objective and forward-looking assessment of the market competitive conditions, of whether such measures are necessary to maintain or achieve effective competition, and of the likely effects of such measures on existing and future investments by market participants in particular for network roll-out. In doing so, they shall take into account the approach to market analysis as set out in Article 67(2). 3. When applying paragraph 2 of this Article, national regulatory and other competent authorities shall act in accordance with the procedures provided in Articles 18, 19, 23 and 35. Section 3 Procedures Article 53 Coordinated timing of assignments 1. Member States shall cooperate in order to coordinate the use of harmonised radio spectrum for electronic communications networks and services in the Union taking due account of the different national market situations. This may include identifying one, or, where appropriate, several common dates by which the use of specific harmonised radio spectrum is to be authorised. 2. Where harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable the radio spectrum use for wireless broadband networks and services, Member States shall allow the use of that radio spectrum, as soon as possible and at the latest 30 months after the adoption of that measure, or as soon as possible after the lifting of any decision to allow alternative use on an exceptional basis pursuant to Article 45(3) of this Directive. This is without prejudice to Decision (EU) 2017/899 and to the Commission\u2019s right of initiative to propose legislative acts. 3. A Member State may delay the deadline provided for in paragraph 2 of this Article for a specific band under the following circumstances: (a) to the extent justified by a restriction to the use of that band based on the general interest objective provided in point (a) or (d) of Article 45(5); (b) in the case of unresolved cross-border coordination issues resulting in harmful interference with third countries, provided the affected Member State has, where appropriate, requested Union assistance pursuant to Article 28(5); (c) safeguarding national security and defence; or (d) force majeure. The Member State concerned shall review such a delay at least every two years. 4. A Member State may delay the deadline provided for in paragraph 2 for a specific band to the extent necessary and up to 30 months in the case of: (a) unresolved cross-border coordination issues resulting in harmful interference between Member States, provided that the affected Member State takes all necessary measures in a timely manner pursuant to Article 28(3) and (4); (b) the need to ensure, and the complexity of ensuring, the technical migration of existing users of that band. 5. In the event of a delay under paragraph 3 or 4, the Member State concerned shall inform the other Member States and the Commission in a timely manner, stating the reasons. Article 54 Coordinated timing of assignments for specific 5G bands 1. By 31 December 2020, for terrestrial systems capable of providing wireless broadband services, Member States shall, where necessary in order to facilitate the roll-out of 5G, take all appropriate measures to: (a) reorganise and allow the use of sufficiently large blocks of the 3,4-3,8 GHz band; (b) allow the use of at least 1 GHz of the 24,25-27,5 GHz band, provided that there is clear evidence of market demand and of the absence of significant constraints for migration of existing users or band clearance. 2. Member States may, however, extend the deadline laid down in paragraph 1 of this Article, where justified, in accordance with Article 45(3) or Article 53(2), (3) or (4). 3. Measures taken pursuant paragraph 1 of this Article shall comply with the harmonised conditions set by technical implementing measures in accordance with Article 4 of Decision No 676/2002/EC. Article 55 Procedure for limiting the number of rights of use to be granted for radio spectrum 1. Without prejudice to Article 53, where a Member State concludes that a right to use radio spectrum cannot be subject to a general authorisation and where it considers whether to limit the number of rights of use to be granted for radio spectrum, it shall, inter alia: (a) clearly state the reasons for limiting the rights of use, in particular by giving due weight to the need to maximise benefits for users and to facilitate the development of competition, and review, as appropriate, the limitation at regular intervals or at the reasonable request of affected undertakings; (b) give all interested parties, including users and consumers, the opportunity to express their views on any limitation through a public consultation in accordance with Article 23. 2. When a Member State concludes that the number of rights of use is to be limited, it shall clearly establish, and give reasons for, the objectives pursued by means of a competitive or comparative selection procedure under this Article, and where possible quantify them, giving due weight to the need to fulfil national and internal market objectives. The objectives that the Member State may set out with a view to designing the specific selection procedure shall, in addition to promoting competition, be limited to one or more of the following: (a) promoting coverage; (b) ensuring the required quality of service; (c) promoting efficient use of radio spectrum, including by taking into account the conditions attached to the rights of use and the level of fees; (d) promoting innovation and business development. The national regulatory or other competent authority shall clearly define and justify the choice of the selection procedure, including any preliminary phase to access the selection procedure. It shall also clearly state the outcome of any related assessment of the competitive, technical and economic situation of the market and provide reasons for the possible use and choice of measures pursuant to Article 35. 3. Member States shall publish any decision on the selection procedure chosen and the related rules, clearly stating the reasons therefor. It shall also publish the conditions that are to be attached to the rights of use. 4. After having determined the selection procedure, the Member State shall invite applications for rights of use. 5. Where a Member State concludes that additional rights of use for radio spectrum or a combination of general authorisation and individual rights of use can be granted, it shall publish that conclusion and initiate the process of granting such rights. 6. Where the granting of rights of use for radio spectrum needs to be limited, Member States shall grant such rights on the basis of selection criteria and a selection procedure which are objective, transparent, non-discriminatory and proportionate. Any such selection criteria shall give due weight to the achievement of the objectives and requirements of Articles 3, 4, 28 and 45. 7. Where competitive or comparative selection procedures are to be used, Member States may extend the maximum period of six weeks referred to in Article 48(6) for as long as necessary to ensure that such procedures are fair, reasonable, open and transparent to all interested parties, but by no longer than eight months, subject to any specific timetable established pursuant to Article 53. Those time limits shall be without prejudice to any applicable international agreements relating to the use of radio spectrum and satellite coordination. 8. This Article is without prejudice to the transfer of rights of use for radio spectrum in accordance with Article 51. CHAPTER IV Deployment and use of wireless network equipment Article 56 Access to radio local area networks 1. Competent authorities shall allow the provision of access through RLANs to a public electronic communications network, as well as the use of the harmonised radio spectrum for that provision, subject only to applicable general authorisation conditions relating to radio spectrum use as referred to in Article 46(1). Where that provision is not part of an economic activity or is ancillary to an economic activity or a public service which is not dependent on the conveyance of signals on those networks, any undertaking, public authority or end-user providing such access shall not be subject to any general authorisation for the provision of electronic communications networks or services pursuant to Article 12, to obligations regarding end-users rights pursuant to Title II of Part III, or to obligations to interconnect their networks pursuant to Article 61(1). 2. Article 12 of Directive 2000/31/EC shall apply. 3. Competent authorities shall not prevent providers of public electronic communications networks or publicly available electronic communications services from allowing access to their networks to the public, through RLANs, which may be located at an end-user\u2019s premises, subject to compliance with the applicable general authorisation conditions and the prior informed agreement of the end-user. 4. In accordance in particular with Article 3(1) of Regulation (EU) 2015/2120, competent authorities shall ensure that providers of public electronic communications networks or publicly available electronic communications services do not unilaterally restrict or prevent end-users from: (a) accessing RLANs of their choice provided by third parties; or (b) allowing reciprocally or, more generally, accessing the networks of such providers by other end-users through RLANs, including on the basis of third-party initiatives which aggregate and make publicly accessible the RLANs of different end-users. 5. Competent authorities shall not limit or prevent end-users from allowing access, reciprocally or otherwise, to their RLANs by other end-users, including on the basis of third-party initiatives which aggregate and make the RLANs of different end-users publicly accessible. 6. Competent authorities shall not unduly restrict the provision of access to RLANs to the public: (a) by public sector bodies or in public spaces close to premises occupied by such public sector bodies, when that provision is ancillary to the public services provided on those premises; (b) by initiatives of non-governmental organisations or public sector bodies to aggregate and make reciprocally or more generally accessible the RLANs of different end-users, including, where applicable, the RLANs to which public access is provided in accordance with point (a). Article 57 Deployment and operation of small-area wireless access points 1. Competent authorities shall not unduly restrict the deployment of small-area wireless access points. Member States shall seek to ensure that any rules governing the deployment of small-area wireless access points are nationally consistent. Such rules shall be published in advance of their application. In particular, competent authorities shall not subject the deployment of small-area wireless access points complying with the characteristics laid down pursuant to paragraph 2 to any individual town planning permit or other individual prior permits. By way of derogation from the second subparagraph of this paragraph, competent authorities may require permits for the deployment of small-area wireless access points on buildings or sites of architectural, historical or natural value protected in accordance with national law or where necessary for public safety reasons. Article 7 of Directive 2014/61/EU shall apply to the granting of those permits. 2. The Commission shall, by means of implementing acts, specify the physical and technical characteristics, such as maximum size, weight, and where appropriate emission power of small-area wireless access points. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). The first such implementing act shall be adopted by 30 June 2020. 3. This Article is without prejudice to the essential requirements laid down in Directive 2014/53/EU and to the authorisation regime applicable for the use of the relevant radio spectrum. 4. Member States shall, by applying, where relevant, the procedures adopted in accordance with Directive 2014/61/EU, ensure that operators have the right to access any physical infrastructure controlled by national, regional or local public authorities, which is technically suitable to host small-area wireless access points or which is necessary to connect such access points to a backbone network, including street furniture, such as light poles, street signs, traffic lights, billboards, bus and tramway stops and metro stations. Public authorities shall meet all reasonable requests for access on fair, reasonable, transparent and non-discriminatory terms and conditions, which shall be made public at a single information point. 5. Without prejudice to any commercial agreements, the deployment of small-area wireless access points shall not be subject to any fees or charges going beyond the administrative charges in accordance with Article 16. Article 58 Technical regulations on electromagnetic fields The procedures laid down in Directive (EU) 2015/1535 shall apply with respect to any draft measure by a Member State that would impose on the deployment of small-area wireless access points different requirements with respect to electromagnetic fields than those provided for in Recommendation 1999/519/EC. TITLE II ACCESS CHAPTER I General provisions, access principles Article 59 General framework for access and interconnection 1. Member States shall ensure that there are no restrictions which prevent undertakings in the same Member State or in different Member States from negotiating between themselves agreements on technical and commercial arrangements for access or interconnection, in accordance with Union law. The undertaking requesting access or interconnection does not need to be authorised to operate in the Member State where access or interconnection is requested, if it is not providing services and does not operate a network in that Member State. 2. Without prejudice to Article 114, Member States shall not maintain legal or administrative measures which require undertakings, when granting access or interconnection, to offer different terms and conditions to different undertakings for equivalent services or measures imposing obligations that are not related to the actual access and interconnection services provided without prejudice to the conditions set out in Annex I. Article 60 Rights and obligations of undertakings 1. Operators of public electronic communications networks shall have a right and, when requested by other undertakings so authorised in accordance with Article 15, an obligation to negotiate with each other interconnection for the purpose of providing publicly available electronic communications services, in order to ensure provision and interoperability of services throughout the Union. Operators shall offer access and interconnection to other undertakings on terms and conditions consistent with obligations imposed by the national regulatory authority pursuant to Articles 61, 62 and 68. 2. Without prejudice to Article 21, Member States shall require that undertakings which acquire information from another undertaking before, during or after the process of negotiating access or interconnection arrangements use that information solely for the purpose for which it was supplied and respect at all times the confidentiality of information transmitted or stored. Such undertakings shall not pass on the received information to any other party, in particular other departments, subsidiaries or partners, for whom such information could provide a competitive advantage. 3. Member States may provide for negotiations to be conducted through neutral intermediaries when conditions of competition so require. CHAPTER II Access and interconnection Article 61 Powers and responsibilities of the national regulatory and other competent authorities with regard to access and interconnection 1. National regulatory authorities or other competent authorities in the case of points (b) and (c) of the first subparagraph of paragraph 2 of this Article shall, acting in pursuit of the objectives set out in Article 3, encourage and, where appropriate, ensure, in accordance with this Directive, adequate access and interconnection, and the interoperability of services, exercising their responsibility in a way that promotes efficiency, sustainable competition, the deployment of very high capacity networks, efficient investment and innovation, and gives the maximum benefit to end-users. They shall provide guidance and make publicly available the procedures applicable to gain access and interconnection to ensure that small and medium-sized enterprises and operators with a limited geographical reach can benefit from the obligations imposed. 2. In particular, without prejudice to measures that may be taken regarding undertakings designated as having significant market power in accordance with Article 68, national regulatory authorities, or other competent authorities in the case of points (b) and (c) of this subparagraph, shall be able to impose: (a) to the extent necessary to ensure end-to-end connectivity, obligations on undertakings subject to general authorisation that control access to end-users, including, in justified cases, the obligation to interconnect their networks where this is not already the case; (b) in justified cases and to the extent necessary, obligations on undertakings subject to general authorisation that control access to end-users to make their services interoperable; (c) in justified cases, where end-to-end connectivity between end-users is endangered due to a lack of interoperability between interpersonal communications services, and to the extent necessary to ensure end-to-end connectivity between end-users, obligations on relevant providers of number-independent interpersonal communications services which reach a significant level of coverage and user uptake, to make their services interoperable; (d) to the extent necessary to ensure accessibility for end-users to digital radio and television broadcasting services and related complementary services specified by the Member State, obligations on operators to provide access to the other facilities referred to in Part II of Annex II on fair, reasonable and non-discriminatory terms. The obligations referred to in point (c) of the first subparagraph shall be imposed only: (i) to the extent necessary to ensure interoperability of interpersonal communications services and may include proportionate obligations on providers of those services to publish and allow the use, modification and redistribution of relevant information by the authorities and other providers, or to use and implement standards or specifications listed in Article 39(1) or of any other relevant European or international standards; (ii) where the Commission, after consulting BEREC and taking utmost account of its opinion, has found an appreciable threat to end-to-end connectivity between end-users throughout the Union or in at least three Member States and has adopted implementing measures specifying the nature and scope of any obligations that may be imposed. The implementing measures referred to in point (ii) of the second subparagraph shall be adopted in accordance with the examination procedure referred to in Article 118(4). 3. In particular, and without prejudice to paragraphs 1 and 2, national regulatory authorities may impose obligations, upon reasonable request, to grant access to wiring and cables and associated facilities inside buildings or up to the first concentration or distribution point as determined by the national regulatory authority, where that point is located outside the building. Where it is justified on the grounds that replication of such network elements would be economically inefficient or physically impracticable, such obligations may be imposed on providers of electronic communications networks or on the owners of such wiring and cables and associated facilities, where those owners are not providers of electronic communications networks. The access conditions imposed may include specific rules on access to such network elements and to associated facilities and associated services, on transparency and non-discrimination and on apportioning the costs of access, which, where appropriate, are adjusted to take into account risk factors. Where a national regulatory authority concludes, having regard, where applicable, to the obligations resulting from any relevant market analysis, that the obligations imposed in accordance with the first subparagraph do not sufficiently address high and non-transitory economic or physical barriers to replication which underlie an existing or emerging market situation significantly limiting competitive outcomes for end-users, it may extend the imposition of such access obligations, on fair and reasonable terms and conditions, beyond the first concentration or distribution point, to a point that it determines to be the closest to end-users, capable of hosting a sufficient number of end-user connections to be commercially viable for efficient access seekers. In determining the extent of the extension beyond the first concentration or distribution point, the national regulatory authority shall take utmost account of relevant BEREC guidelines. If justified on technical or economic grounds, national regulatory authorities may impose active or virtual access obligations. National regulatory authorities shall not impose obligations in accordance with the second subparagraph on providers of electronic communications networks where they determine that: (a) the provider has the characteristics listed in Article 80(1) and makes available a viable and similar alternative means of reaching end-users by providing access to a very high capacity network to any undertaking, on fair, non-discriminatory and reasonable terms and conditions; national regulatory authorities may extend that exemption to other providers offering, on fair, non-discriminatory and reasonable terms and conditions, access to a very high capacity network; or (b) the imposition of obligations would compromise the economic or financial viability of a new network deployment, in particular by small local projects. By way of derogation from point (a) of the third subparagraph, national regulatory authorities may impose obligations on providers of electronic communications networks fulfilling the criteria laid down in that point where the network concerned is publicly funded. By 21 December 2020, BEREC shall publish guidelines to foster a consistent application of this paragraph, by setting out the relevant criteria for determining: (a) the first concentration or distribution point; (b) the point, beyond the first concentration or distribution point, capable of hosting a sufficient number of end-user connections to enable an efficient undertaking to overcome the significant replicability barriers identified; (c) which network deployments can be considered to be new; (d) which projects can be considered to be small; and (e) which economic or physical barriers to replication are high and non-transitory. 4. Without prejudice to paragraphs 1 and 2, Member States shall ensure that competent authorities have the power to impose on undertakings providing or authorised to provide electronic communications networks obligations in relation to the sharing of passive infrastructure or obligations to conclude localised roaming access agreements, in both cases if directly necessary for the local provision of services which rely on the use of radio spectrum, in accordance with Union law and provided that no viable and similar alternative means of access to end-users is made available to any undertaking on fair and reasonable terms and conditions. Competent authorities may impose such obligations only where this possibility is clearly provided for when granting the rights of use for radio spectrum and where justified on the grounds that, in the area subject to such obligations, the market-driven deployment of infrastructure for the provision of networks or services which rely on the use of radio spectrum is subject to insurmountable economic or physical obstacles and therefore access to networks or services by end-users is severely deficient or absent. In those circumstances where access and sharing of passive infrastructure alone does not suffice to address the situation, national regulatory authorities may impose obligations on sharing of active infrastructure. Competent authorities shall have regard to: (a) the need to maximise connectivity throughout the Union, along major transport paths and in particular territorial areas, and to the possibility to significantly increase choice and higher quality of service for end-users; (b) the efficient use of radio spectrum; (c) the technical feasibility of sharing and associated conditions; (d) the state of infrastructure-based as well as service-based competition; (e) technological innovation; (f) the overriding need to support the incentive of the host to roll out the infrastructure in the first place. In the event of dispute resolution, competent authorities may, inter alia, impose on the beneficiary of the sharing or access obligation, the obligation to share radio spectrum with the infrastructure host in the relevant area. 5. Obligations and conditions imposed in accordance with paragraphs 1 to 4 of this Article shall be objective, transparent, proportionate and non-discriminatory, they shall be implemented in accordance with the procedures referred to in Articles 23, 32 and 33. The national regulatory and other competent authorities which have imposed such obligations and conditions shall assess the results thereof by five years after the adoption of the previous measure adopted in relation to the same undertakings and assess whether it would be appropriate to withdraw or amend them in light of evolving conditions. Those authorities shall notify the outcome of their assessment in accordance with the procedures referred to in Articles 23, 32 and 33. 6. For the purpose of paragraphs 1 and 2 of this Article, Member States shall ensure that the national regulatory authority is empowered to intervene on its own initiative where justified in order to secure the policy objectives of Article 3, in accordance with this Directive and, in particular, with the procedures referred to in Articles 23 and 32. 7. By 21 June 2020 in order to contribute to a consistent definition of the location of network termination points by national regulatory authorities, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, adopt guidelines on common approaches to the identification of the network termination point in different network topologies. National regulatory authorities shall take utmost account of those guidelines when defining the location of network termination points. Article 62 Conditional access systems and other facilities 1. Member States shall ensure that the conditions laid down in Part I of Annex II apply in relation to conditional access to digital television and radio services broadcast to viewers and listeners in the Union, irrespective of the means of transmission. 2. Where, as a result of a market analysis carried out in accordance with Article 67(1), a national regulatory authority finds that one or more undertakings do not have significant market power on the relevant market, it may amend or withdraw the conditions with respect to those undertakings, in accordance with the procedures referred to in Articles 23 and 32, only to the extent that: (a) accessibility for end-users to radio and television broadcasts and broadcasting channels and services specified in accordance with Article 114 would not be adversely affected by such amendment or withdrawal; and (b) the prospects for effective competition in the following markets would not be adversely affected by such amendment or withdrawal: (i) retail digital television and radio broadcasting services; and (ii) conditional access systems and other associated facilities. An appropriate notice period shall be given to parties affected by such amendment or withdrawal of conditions. 3. Conditions applied in accordance with this Article are without prejudice to the ability of Member States to impose obligations in relation to the presentational aspect of EPGs and similar listing and navigation facilities. 4. Notwithstanding paragraph 1 of this Article, Member States may allow their national regulatory authority, as soon as possible after 20 December 2018 and periodically thereafter, to review the conditions applied in accordance with this Article, by undertaking a market analysis in accordance with Article 67(1) to determine whether to maintain, amend or withdraw the conditions applied. CHAPTER III Market analysis and significant market power Article 63 Undertakings with significant market power 1. Where this Directive requires national regulatory authorities to determine whether undertakings have significant market power in accordance with the procedure referred to in Article 67, paragraph 2 of this Article shall apply. 2. An undertaking shall be deemed to have significant market power if, either individually or jointly with others, it enjoys a position equivalent to dominance, namely a position of economic strength affording it the power to behave to an appreciable extent independently of competitors, customers and ultimately consumers. In particular, national regulatory authorities shall, when assessing whether two or more undertakings are in a joint dominant position in a market, act in accordance with Union law and take into the utmost account the guidelines on market analysis and the assessment of significant market power published by the Commission pursuant to Article 64. 3. Where an undertaking has significant market power on a specific market, it may also be designated as having significant market power on a closely related market, where the links between the two markets allow the market power held on the specific market to be leveraged into the closely related market, thereby strengthening the market power of the undertaking. Consequently, remedies aiming to prevent such leverage may be applied in the closely related market pursuant to Articles 69, 70, 71 and 74. Article 64 Procedure for the identification and definition of markets 1. After public consultation including with national regulatory authorities and taking the utmost account of the opinion of BEREC, the Commission shall adopt a Recommendation on Relevant Product and Service Markets (\u2018the Recommendation\u2019). The Recommendation shall identify those product and service markets within the electronic communications sector the characteristics of which may be such as to justify the imposition of regulatory obligations set out in this Directive, without prejudice to markets that may be defined in specific cases under competition law. The Commission shall define markets in accordance with the principles of competition law. The Commission shall include product and service markets in the Recommendation where, after observing overall trends in the Union, it finds that each of the three criteria listed in Article 67(1) is met. The Commission shall review the Recommendation by 21 December 2020 and regularly thereafter. 2. After consulting BEREC, the Commission shall publish guidelines for market analysis and the assessment of significant market power (\u2018the SMP guidelines\u2019) which shall be in accordance with the relevant principles of competition law. The SMP guidelines shall include guidance to national regulatory authorities on the application of the concept of significant market power to the specific context of ex ante regulation of electronic communications markets, taking account of the three criteria listed in Article 67(1). 3. National regulatory authorities shall, taking the utmost account of the Recommendation and the SMP guidelines, define relevant markets appropriate to national circumstances, in particular relevant geographic markets within their territory by taking into account, inter alia, the degree of infrastructure competition in those areas, in accordance with the principles of competition law. National regulatory authorities shall, where relevant, also take into account the results of the geographical survey conducted in accordance with Article 22(1). They shall follow the procedures referred to in Articles 23 and 32 before defining the markets that differ from those identified in the Recommendation. Article 65 Procedure for the identification of transnational markets 1. If the Commission or at least two national regulatory authorities concerned submit a reasoned request, including supporting evidence, BEREC shall conduct an analysis of a potential transnational market. After consulting stakeholders and taking utmost account of the analysis carried out by BEREC, the Commission may adopt decisions identifying transnational markets in accordance with the principles of competition law and taking utmost account of the Recommendation and SMP guidelines adopted in accordance with Article 64. 2. In the case of transnational markets identified in accordance with paragraph 1 of this Article, the national regulatory authorities concerned shall jointly conduct the market analysis taking the utmost account of the SMP guidelines and, in a concerted fashion, shall decide on any imposition, maintenance, amendment or withdrawal of regulatory obligations referred to in Article 67(4). The national regulatory authorities concerned shall jointly notify to the Commission their draft measures regarding the market analysis and any regulatory obligations pursuant to Articles 32 and 33. Two or more national regulatory authorities may also jointly notify their draft measures regarding the market analysis and any regulatory obligations in the absence of transnational markets, where they consider that market conditions in their respective jurisdictions are sufficiently homogeneous. Article 66 Procedure for the identification of transnational demand 1. BEREC shall conduct an analysis of transnational end-user demand for products and services that are provided within the Union in one or more of the markets listed in the Recommendation, if it receives a reasoned request providing supporting evidence from the Commission or from at least two of the national regulatory authorities concerned indicating that there is a serious demand problem to be addressed. BEREC may also conduct such analysis if it receives a reasoned request from market participants providing sufficient supporting evidence and considers that there is a serious demand problem to be addressed. BEREC\u2019s analysis is without prejudice to any findings of transnational markets in accordance with Article 65(1) and to any findings of national or sub-national geographical markets by national regulatory authorities in accordance with Article 64(3). That analysis of transnational end-user demand may include products and services that are supplied within product or service markets that have been defined in different ways by one or more national regulatory authorities when taking into account national circumstances, provided that those products and services are substitutable to those supplied in one of the markets listed in the Recommendation. 2. If BEREC concludes that a transnational end-user demand exists, is significant and is not sufficiently met by supply provided on a commercial or regulated basis, it shall, after consulting stakeholders and in close cooperation with the Commission, issue guidelines on common approaches for national regulatory authorities to meet the identified transnational demand, including, where appropriate, when they impose remedies in accordance with Article 68. National regulatory authorities shall take into utmost account those guidelines when performing their regulatory tasks within their jurisdiction. Those guidelines may provide the basis for interoperability of wholesale access products across the Union and may include guidance for the harmonisation of technical specifications of wholesale access products capable of meeting such identified transnational demand. Article 67 Market analysis procedure 1. National regulatory authorities shall determine whether a relevant market defined in accordance with Article 64(3) is such as to justify the imposition of the regulatory obligations set out in this Directive. Member States shall ensure that an analysis is carried out, where appropriate, in collaboration with the national competition authorities. National regulatory authorities shall take utmost account of the SMP guidelines and shall follow the procedures referred to in Articles 23 and 32 when conducting such analysis. A market may be considered to justify the imposition of regulatory obligations set out in this Directive if all of the following criteria are met: (a) high and non-transitory structural, legal or regulatory barriers to entry are present; (b) there is a market structure which does not tend towards effective competition within the relevant time horizon, having regard to the state of infrastructure-based competition and other sources of competition behind the barriers to entry; (c) competition law alone is insufficient to adequately address the identified market failure(s). Where a national regulatory authority conducts an analysis of a market that is included in the Recommendation, it shall consider that points (a), (b) and (c) of the second subparagraph have been met, unless the national regulatory authority determines that one or more of such criteria is not met in the specific national circumstances. 2. Where a national regulatory authority conducts the analysis required by paragraph 1, it shall consider developments from a forward-looking perspective in the absence of regulation imposed on the basis of this Article in that relevant market, and taking into account all of the following: (a) market developments affecting the likelihood of the relevant market tending towards effective competition; (b) all relevant competitive constraints, at the wholesale and retail levels, irrespective of whether the sources of such constraints are considered to be electronic communications networks, electronic communications services, or other types of services or applications which are comparable from the perspective of the end-user, and irrespective of whether such constraints are part of the relevant market; (c) other types of regulation or measures imposed and affecting the relevant market or related retail market or markets throughout the relevant period, including, without limitation, obligations imposed in accordance with Articles 44, 60 and 61; (d) regulation imposed on other relevant markets on the basis of this Article. 3. Where a national regulatory authority concludes that a relevant market does not justify the imposition of regulatory obligations in accordance with the procedure in paragraphs 1 and 2 of this Article, or where the conditions set out in paragraph 4 of this Article are not met, it shall not impose or maintain any specific regulatory obligations in accordance with Article 68. Where there already are sector specific regulatory obligations imposed in accordance with Article 68, it shall withdraw such obligations placed on undertakings in that relevant market. National regulatory authorities shall ensure that parties affected by such a withdrawal of obligations receive an appropriate notice period, defined by balancing the need to ensure a sustainable transition for the beneficiaries of those obligations and end-users, end-user choice, and that regulation does not continue for longer than necessary. When setting such a notice period, national regulatory authorities may determine specific conditions and notice periods in relation to existing access agreements. 4. Where a national regulatory authority determines that, in a relevant market the imposition of regulatory obligations in accordance with paragraphs 1 and 2 of this Article is justified, it shall identify any undertakings which individually or jointly have a significant market power on that relevant market in accordance with Article 63. The national regulatory authority shall impose on such undertakings appropriate specific regulatory obligations in accordance with Article 68 or maintain or amend such obligations where they already exist if it considers that the outcome for end-users would not be effectively competitive in the absence of those obligations. 5. Measures taken in accordance with paragraphs 3 and 4 of this Article shall be subject to the procedures referred to in Articles 23 and 32. National regulatory authorities shall carry out an analysis of the relevant market and notify the corresponding draft measure in accordance with Article 32: (a) within five years from the adoption of a previous measure where the national regulatory authority has defined the relevant market and determined which undertakings have significant market power; that five-year period may, on an exceptional basis, be extended for up to one year, where the national regulatory authority has notified a reasoned proposal for an extension to the Commission no later than four months before the expiry of the five-year period, and the Commission has not objected within one month of the notified extension; (b) within three years from the adoption of a revised Recommendation on relevant markets, for markets not previously notified to the Commission; or (c) within three years from their accession, for Member States which have newly joined the Union. 6. Where a national regulatory authority considers that it may not complete or has not completed its analysis of a relevant market identified in the Recommendation within the time limit laid down in paragraph 5 of this Article, BEREC shall, upon request, provide assistance to the national regulatory authority concerned in completing the analysis of the specific market and the specific obligations to be imposed. With this assistance, the national regulatory authority concerned shall, within six months of the limit laid down in paragraph 5 of this Article, notify the draft measure to the Commission in accordance with Article 32. CHAPTER IV Access remedies imposed on undertakings with significant market power Article 68 Imposition, amendment or withdrawal of obligations 1. Member States shall ensure that national regulatory authorities are empowered to impose the obligations set out in Articles 69 to 74 and Articles 76 to 81. 2. Where an undertaking is designated as having significant market power on a specific market as a result of a market analysis carried out in accordance with Article 67, national regulatory authorities shall, as appropriate, impose any of the obligations set out in Articles 69 to 74 and Articles 76 and 80. In accordance with the principle of proportionality, a national regulatory authority shall choose the least intrusive way of addressing the problems identified in the market analysis. 3. National regulatory authorities shall impose the obligations set out in Articles 69 to 74 and Articles 76 and 80 only on undertakings that have been designated as having significant market power in accordance with paragraph 2 of this Article, without prejudice to: (a) Articles 61 and 62; (b) Articles 44 and 17 of this Directive, Condition 7 in Part D of Annex I as applied by virtue of Article 13(1) of this Directive, Articles 97 and 106 of this Directive and the relevant provisions of Directive 2002/58/EC containing obligations on undertakings other than those designated as having significant market power; or (c) the need to comply with international commitments. In exceptional circumstances, where a national regulatory authority intends to impose on undertakings designated as having significant market power obligations for access or interconnection other than those set out in Articles 69 to 74 and Articles 76 and 80, it shall submit a request to the Commission. The Commission shall, taking utmost account of the opinion of BEREC, adopt decisions by means of implementing acts, authorising or preventing the national regulatory authority from taking such measures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 118(3). 4. Obligations imposed in accordance with this Article shall be: (a) based on the nature of the problem identified by a national regulatory authority in its market analysis, where appropriate taking into account the identification of transnational demand pursuant to Article 66; (b) proportionate, having regard, where possible, to the costs and benefits; (c) justified in light of the objectives laid down in Article 3; and (d) imposed following consultation in accordance with Articles 23 and 32. 5. In relation to the need to comply with international commitments referred to in paragraph 3 of this Article, national regulatory authorities shall notify decisions to impose, amend or withdraw obligations on undertakings to the Commission, in accordance with the procedure referred to in Article 32. 6. National regulatory authorities shall consider the impact of new market developments, such as in relation to commercial agreements, including co-investment agreements, influencing competitive dynamics. If those developments are not sufficiently important to require a new market analysis in accordance with Article 67, the national regulatory authority shall assess without delay whether it is necessary to review the obligations imposed on undertakings designated as having significant market power and amend any previous decision, including by withdrawing obligations or imposing new obligations, in order to ensure that such obligations continue to meet the conditions set out in paragraph 4 of this Article. Such amendments shall be imposed only after consultations in accordance with Articles 23 and 32. Article 69 Obligation of transparency 1. National regulatory authorities may, in accordance with Article 68, impose obligations of transparency in relation to interconnection or access, requiring undertakings to make public specific information, such as accounting information, prices, technical specifications, network characteristics and expected developments thereof, as well as terms and conditions for supply and use, including any conditions altering access to or use of services and applications, in particular with regard to migration from legacy infrastructure, where such conditions are allowed by Member States in accordance with Union law. 2. In particular, where an undertaking has obligations of non-discrimination, national regulatory authorities may require that undertaking to publish a reference offer, which shall be sufficiently unbundled to ensure that undertakings are not required to pay for facilities which are not necessary for the service requested. That offer shall contain a description of the relevant offerings broken down into components according to market needs, and the associated terms and conditions, including prices. The national regulatory authority may, inter alia, impose changes to reference offers to give effect to obligations imposed under this Directive. 3. National regulatory authorities may specify the precise information to be made available, the level of detail required and the manner of publication. 4. By 21 December 2019, in order to contribute to the consistent application of transparency obligations, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, issue guidelines on the minimum criteria for a reference offer and shall review them where necessary in order to adapt them to technological and market developments. In providing such minimum criteria, BEREC shall pursue the objectives in Article 3, and shall have regard to the needs of the beneficiaries of access obligations and of end-users that are active in more than one Member State, as well as to any BEREC guidelines identifying transnational demand in accordance with Article 66 and to any related decision of the Commission. Notwithstanding paragraph 3 of this Article, where an undertaking has obligations under Article 72 or 73 concerning wholesale access to network infrastructure, national regulatory authorities shall ensure the publication of a reference offer taking utmost account of the BEREC guidelines on the minimum criteria for a reference offer, shall ensure that key performance indicators are specified, where relevant, as well as corresponding service levels, and closely monitor and ensure compliance with them. In addition, national regulatory authorities may, where necessary, predetermine the associated financial penalties in accordance with Union and national law. Article 70 Obligations of non-discrimination 1. A national regulatory authority may, in accordance with Article 68, impose obligations of non-discrimination, in relation to interconnection or access. 2. Obligations of non-discrimination shall ensure, in particular, that the undertaking applies equivalent conditions in equivalent circumstances to other providers of equivalent services, and provides services and information to others under the same conditions and of the same quality as it provides for its own services, or those of its subsidiaries or partners. National regulatory authorities may impose on that undertaking obligations to supply access products and services to all undertakings, including to itself, on the same timescales, terms and conditions, including those relating to price and service levels, and by means of the same systems and processes, in order to ensure equivalence of access. Article 71 Obligation of accounting separation 1. A national regulatory authority may, in accordance with Article 68, impose obligations for accounting separation in relation to specified activities related to interconnection or access. In particular, a national regulatory authority may require a vertically integrated undertaking to make transparent its wholesale prices and its internal transfer prices, inter alia to ensure compliance where there is an obligation of non-discrimination under Article 70 or, where necessary, to prevent unfair cross-subsidy. National regulatory authorities may specify the format and accounting methodology to be used. 2. Without prejudice to Article 20, to facilitate the verification of compliance with obligations of transparency and non-discrimination, national regulatory authorities shall have the power to require that accounting records, including data on revenues received from third parties, are provided on request. National regulatory authorities may publish information that would contribute to an open and competitive market, while complying with Union and national rules on commercial confidentiality. Article 72 Access to civil engineering 1. A national regulatory authority may, in accordance with Article 68, impose obligations on undertakings to meet reasonable requests for access to, and use of, civil engineering including, but not limited to, buildings or entries to buildings, building cables, including wiring, antennae, towers and other supporting constructions, poles, masts, ducts, conduits, inspection chambers, manholes, and cabinets, in situations where, having considered the market analysis, the national regulatory authority concludes that denial of access or access given under unreasonable terms and conditions having a similar effect would hinder the emergence of a sustainable competitive market and would not be in the end-user\u2019s interest. 2. National regulatory authorities may impose obligations on an undertaking to provide access in accordance with this Article, irrespective of whether the assets that are affected by the obligation are part of the relevant market in accordance with the market analysis, provided that the obligation is necessary and proportionate to meet the objectives of Article 3. Article 73 Obligations of access to, and use of, specific network elements and associated facilities 1. National regulatory authorities may, in accordance with Article 68, impose obligations on undertakings to meet reasonable requests for access to, and use of, specific network elements and associated facilities, in situations where the national regulatory authorities consider that denial of access or unreasonable terms and conditions having a similar effect would hinder the emergence of a sustainable competitive market at the retail level, and would not be in the end-user\u2019s interest. National regulatory authorities may require undertakings inter alia: (a) to give third parties access to, and use of, specific physical network elements and associated facilities, as appropriate, including unbundled access to the local loop and sub-loop; (b) to give third parties access to specific active or virtual network elements and services; (c) to negotiate in good faith with undertakings requesting access; (d) not to withdraw access to facilities already granted; (e) to provide specific services on a wholesale basis for resale by third parties; (f) to grant open access to technical interfaces, protocols or other key technologies that are indispensable for the interoperability of services or virtual network services; (g) to provide co-location or other forms of associated facilities sharing; (h) to provide specific services needed to ensure interoperability of end-to-end services to users, or roaming on mobile networks; (i) to provide access to operational support systems or similar software systems necessary to ensure fair competition in the provision of services; (j) to interconnect networks or network facilities; (k) to provide access to associated services such as identity, location and presence service. National regulatory authorities may subject those obligations to conditions covering fairness, reasonableness and timeliness. 2. Where national regulatory authorities consider the appropriateness of imposing any of the possible specific obligations referred to in paragraph 1 of this Article, and in particular where they assess, in accordance with the principle of proportionality, whether and how such obligations are to be imposed, they shall analyse whether other forms of access to wholesale inputs, either on the same or on a related wholesale market, would be sufficient to address the identified problem in the end-user\u2019s interest. That assessment shall include commercial access offers, regulated access pursuant to Article 61, or existing or planned regulated access to other wholesale inputs pursuant to this Article. National regulatory authorities shall take account in particular of the following factors: (a) the technical and economic viability of using or installing competing facilities, in light of the rate of market development, taking into account the nature and type of interconnection or access involved, including the viability of other upstream access products, such as access to ducts; (b) the expected technological evolution affecting network design and management; (c) the need to ensure technology neutrality enabling the parties to design and manage their own networks; (d) the feasibility of providing the access offered, in relation to the capacity available; (e) the initial investment by the facility owner, taking account of any public investment made and the risks involved in making the investment, with particular regard to investments in, and risk levels associated with, very high capacity networks; (f) the need to safeguard competition in the long term, with particular attention to economically efficient infrastructure-based competition and innovative business models that support sustainable competition, such as those based on co-investment in networks; (g) where appropriate, any relevant intellectual property rights; (h) the provision of pan-European services. Where a national regulatory authority considers, in accordance with Article 68, imposing obligations on the basis of Articles 72 or of this Article, it shall examine whether the imposition of obligations in accordance with Article 72 alone would be a proportionate means by which to promote competition and the end-user's interest. 3. When imposing obligations on an undertaking to provide access in accordance with this Article, national regulatory authorities may lay down technical or operational conditions to be met by the provider or the beneficiaries of such access, where necessary to ensure normal operation of the network. Obligations to follow specific technical standards or specifications shall comply with the standards and specifications laid down in accordance with Article 39. Article 74 Price control and cost accounting obligations 1. A national regulatory authority may, in accordance with Article 68, impose obligations relating to cost recovery and price control, including obligations for cost orientation of prices and obligations concerning cost-accounting systems, for the provision of specific types of interconnection or access, in situations where a market analysis indicates that a lack of effective competition means that the undertaking concerned may sustain prices at an excessively high level, or may apply a price squeeze, to the detriment of end-users. In determining whether price control obligations would be appropriate, national regulatory authorities shall take into account the need to promote competition and long-term end-user interests related to the deployment and take-up of next-generation networks, and in particular of very high capacity networks. In particular, to encourage investments by the undertaking, including in next-generation networks, national regulatory authorities shall take into account the investment made by the undertaking. Where the national regulatory authorities consider price control obligations to be appropriate, they shall allow the undertaking a reasonable rate of return on adequate capital employed, taking into account any risks specific to a particular new investment network project. National regulatory authorities shall consider not imposing or maintaining obligations pursuant to this Article, where they establish that a demonstrable retail price constraint is present and that any obligations imposed in accordance with Articles 69 to 73, including, in particular, any economic replicability test imposed in accordance with Article 70, ensures effective and non-discriminatory access. When national regulatory authorities consider it appropriate to impose price control obligations on access to existing network elements, they shall also take account of the benefits of predictable and stable wholesale prices in ensuring efficient market entry and sufficient incentives for all undertakings to deploy new and enhanced networks. 2. National regulatory authorities shall ensure that any cost recovery mechanism or pricing methodology that is mandated serves to promote the deployment of new and enhanced networks, efficiency and sustainable competition and maximises sustainable end-user benefits. In this regard, national regulatory authorities may also take account of prices available in comparable competitive markets. 3. Where an undertaking has an obligation regarding the cost orientation of its prices, the burden of proof that charges are derived from costs, including a reasonable rate of return on investment, shall lie with the undertaking concerned. For the purpose of calculating the cost of efficient provision of services, national regulatory authorities may use cost accounting methods independent of those used by the undertaking. National regulatory authorities may require an undertaking to provide full justification for its prices, and may, where appropriate, require prices to be adjusted. 4. National regulatory authorities shall ensure that, where implementation of a cost-accounting system is mandated in order to support price control, a description of the cost-accounting system is made publicly available, showing at least the main categories under which costs are grouped and the rules used for the allocation of costs. A qualified independent body shall verify compliance with the cost-accounting system and shall publish annually a statement concerning compliance. Article 75 Termination rates 1. By 31 December 2020, the Commission shall, taking utmost account of the opinion of BEREC, adopt a delegated act in accordance with Article 117 supplementing this Directive by setting a single maximum Union-wide mobile voice termination rate and a single maximum Union-wide fixed voice termination rate (together referred to as \u2018the Union-wide voice termination rates\u2019), which are imposed on any provider of mobile voice termination or fixed voice termination services, respectively, in any Member State. To that end, the Commission shall: (a) comply with the principles, criteria and parameters provided in Annex III; (b) when setting the Union-wide voice termination rates for the first time, take into account the weighted average of efficient costs in fixed and mobile networks established in accordance with the principles provided in Annex III, applied across the Union; the Union-wide voice termination rates in the first delegated act shall not be higher than the highest rate among the rates that were in force six months before the adoption of that delegated act in all Member States, after any necessary adjustment for exceptional national circumstances; (c) take into account the total number of end-users in each Member State, in order to ensure a proper weighting of the maximum termination rates, as well as national circumstances which result in significant differences between Member States when determining the maximum termination rates in the Union; (d) take into account market information provided by BEREC, national regulatory authorities or, directly, by undertakings providing electronic communications networks and services; and (e) consider the need to allow for a transitional period of no longer than 12 months in order to allow adjustments in Member States where this is necessary on the basis of rates previously imposed. 2. Taking utmost account of the opinion of BEREC, the Commission shall review the delegated act adopted pursuant to this Article every five years and shall consider on each such occasion, by applying the criteria listed in Article 67(1), whether setting Union-wide voice termination rates continue to be necessary. Where the Commission decides, following its review in accordance with this paragraph, not to impose a maximum mobile voice termination rate or a maximum fixed voice termination rate, or neither, national regulatory authorities may conduct market analyses of voice termination markets in accordance with Article 67, to assess whether the imposition of regulatory obligations is necessary. If a national regulatory authority imposes, as a result of such analysis, cost-oriented termination rates in a relevant market, it shall follow the principles, criteria and parameters set out in Annex III and its draft measure shall be subject to the procedures referred to in Articles 23, 32 and 33. 3. National regulatory authorities shall closely monitor, and ensure compliance with, the application of the Union-wide voice termination rates by providers of voice termination services. National regulatory authorities may, at any time, require a provider of voice termination services to amend the rate it charges to other undertakings if it does not comply with the delegated act referred to in paragraph 1. National regulatory authorities shall annually report to the Commission and to BEREC with regard to the application of this Article. Article 76 Regulatory treatment of new very high capacity network elements 1. Undertakings which have been designated as having significant market power in one or several relevant markets in accordance with Article 67 may offer commitments, in accordance with the procedure set out in Article 79 and subject to the second subparagraph of this paragraph, to open the deployment of a new very high capacity network that consists of optical fibre elements up to the end-user premises or base station to co-investment, for example by offering co-ownership or long-term risk sharing through co-financing or through purchase agreements giving rise to specific rights of a structural character by other providers of electronic communications networks or services. When the national regulatory authority assesses those commitments, it shall determine, in particular, whether the offer to co-invest complies with all of the following conditions: (a) it is open at any moment during the lifetime of the network to any provider of electronic communications networks or services; (b) it would allow other co-investors which are providers of electronic communications networks or services to compete effectively and sustainably in the long term in downstream markets in which the undertaking designated as having significant market power is active, on terms which include: (i) fair, reasonable and non-discriminatory terms allowing access to the full capacity of the network to the extent that it is subject to co-investment; (ii) flexibility in terms of the value and timing of the participation of each co-investor; (iii) the possibility to increase such participation in the future; and (iv) reciprocal rights awarded by the co-investors after the deployment of the co-invested infrastructure; (c) it is made public by the undertaking in a timely manner and, if the undertaking does not have the characteristics listed in Article 80(1), at least six months before the start of the deployment of the new network; that period may be prolonged based on national circumstances; (d) access seekers not participating in the co-investment can benefit from the outset from the same quality, speed, conditions and end-user reach as were available before the deployment, accompanied by a mechanism of adaptation over time confirmed by the national regulatory authority in light of developments on the related retail markets, that maintains the incentives to participate in the co-investment; such mechanism shall ensure that access seekers have access to the very high capacity elements of the network at a time, and on the basis of transparent and non-discriminatory terms, which reflect appropriately the degrees of risk incurred by the respective co-investors at different stages of the deployment and take into account the competitive situation in retail markets; (e) it complies at a minimum with the criteria set out in Annex IV and is made in good faith. 2. If the national regulatory authority concludes, taking into account the results of the market test conducted in accordance with Article 79(2), that the co-investment commitment offered complies with the conditions set out in paragraph 1 of this Article, it shall make that commitment binding pursuant to Article 79(3), and shall not impose any additional obligations pursuant to Article 68 as regards the elements of the new very high capacity network that are subject to the commitments, if at least one potential co-investor has entered into a co-investment agreement with the undertaking designated as having significant market power. The first subparagraph shall be without prejudice to the regulatory treatment of circumstances that do not comply with the conditions set out in paragraph 1 of this Article, taking into account the results of any market test conducted in accordance with Article 79(2), but that have an impact on competition and are taken into account for the purposes of Articles 67 and 68. By way of derogation from the first subparagraph of this paragraph, a national regulatory authority may, in duly justified circumstances, impose, maintain or adapt remedies in accordance with Articles 68 to 74 as regards new very high capacity networks in order to address significant competition problems on specific markets, where the national regulatory authority establishes that, given the specific characteristics of these markets, those competition problems would not otherwise be addressed. 3. National regulatory authorities shall, on an ongoing basis, monitor compliance with the conditions set out in paragraph 1 and may require the undertaking designated as having significant market power to provide it with annual compliance statements. This Article shall be without prejudice to the power of a national regulatory authority to take decisions pursuant to Article 26(1) in the event of a dispute arising between undertakings in connection with a co-investment agreement considered by it to comply with the conditions set out in paragraph 1 of this Article. 4. BEREC, after consulting stakeholders and in close cooperation with the Commission, shall publish guidelines to foster the consistent application by national regulatory authorities of the conditions set out in paragraph 1, and the criteria set out in Annex IV. Article 77 Functional separation 1. Where the national regulatory authority concludes that the appropriate obligations imposed under Articles 69 to 74 have failed to achieve effective competition and that there are important and persisting competition problems or market failures identified in relation to the wholesale provision of certain access product markets, it may, on an exceptional basis, in accordance with the second subparagraph of Article 68(3), impose an obligation on vertically integrated undertakings to place activities related to the wholesale provision of relevant access products in a business entity operating independently. That business entity shall supply access products and services to all undertakings, including to other business entities within the parent company, on the same timescales, terms and conditions, including those relating to price and service levels, and by means of the same systems and processes. 2. When a national regulatory authority intends to impose an obligation of functional separation, it shall submit a request to the Commission that includes: (a) evidence justifying the conclusions of the national regulatory authority as referred to in paragraph 1; (b) a reasoned assessment concluding that there is no or little prospect of effective and sustainable infrastructure-based competition within a reasonable time-frame; (c) an analysis of the expected impact on the national regulatory authority, on the undertaking, in particular on the workforce of the separated undertaking, and on the electronic communications sector as a whole, and on incentives to invest therein, in particular with regard to the need to ensure social and territorial cohesion, and on other stakeholders including, in particular, the expected impact on competition and any potential resulting effects on consumers; (d) an analysis of the reasons justifying that this obligation would be the most efficient means to enforce remedies aimed at addressing the competition problems or the markets failures identified. 3. The draft measure shall include the following elements: (a) the precise nature and level of separation, specifying in particular the legal status of the separate business entity; (b) an identification of the assets of the separate business entity, and the products or services to be supplied by that entity; (c) the governance arrangements to ensure the independence of the staff employed by the separate business entity, and the corresponding incentive structure; (d) rules for ensuring compliance with the obligations; (e) rules for ensuring transparency of operational procedures, in particular towards other stakeholders; (f) a monitoring programme to ensure compliance, including the publication of an annual report. Following the Commission\u2019s decision taken in accordance with Article 68(3) on that draft measure, the national regulatory authority shall conduct a coordinated analysis of the different markets related to the access network in accordance with the procedure set out in Article 67. On the basis of that analysis, the national regulatory authority shall impose, maintain, amend or withdraw obligations, in accordance with the procedures set out in Articles 23 and 32. 4. An undertaking on which functional separation has been imposed may be subject to any of the obligations referred to in Articles 69 to 74 in any specific market where it has been designated as having significant market power in accordance with Article 67, or any other obligations authorised by the Commission pursuant to Article 68(3). Article 78 Voluntary separation by a vertically integrated undertaking 1. Undertakings which have been designated as having significant market power in one or several relevant markets in accordance with Article 67 shall inform the national regulatory authority at least three months before any intended transfer of their local access network assets or a substantial part thereof to a separate legal entity under different ownership, or establishment of a separate business entity in order to provide all retail providers, including its own retail divisions, with fully equivalent access products. Those undertakings shall also inform the national regulatory authority of any change of that intent, as well as the final outcome of the process of separation. Such undertakings may also offer commitments regarding access conditions that are to apply to their network during an implementation period after the proposed form of separation is implemented, with a view to ensuring effective and non-discriminatory access by third parties. The offer of commitments shall include sufficient details, including in terms of timing of implementation and duration, in order to allow the national regulatory authority to conduct its tasks in accordance with paragraph 2 of this Article. Such commitments may extend beyond the maximum period for market reviews set out in Article 67(5). 2. The national regulatory authority shall assess the effect of the intended transaction, together with the commitments offered, where applicable, on existing regulatory obligations under this Directive. For that purpose, the national regulatory authority shall conduct an analysis of the different markets related to the access network in accordance with the procedure set out in Article 67. The national regulatory authority shall take into account any commitments offered by the undertaking, having regard in particular to the objectives set out in Article 3. In so doing, the national regulatory authority shall consult third parties in accordance with Article 23, and shall address, in particular, those third parties which are directly affected by the intended transaction. On the basis of its analysis, the national regulatory authority shall impose, maintain, amend or withdraw obligations, in accordance with the procedures set out in Articles 23 and 32, applying, if appropriate, Article 80. In its decision, the national regulatory authority may make the commitments binding, wholly or in part. By way of derogation from Article 67(5), the national regulatory authority may make the commitments binding, wholly or in part, for the entire period for which they are offered. 3. Without prejudice to Article 80, the legally or operationally separate business entity that has been designated as having significant market power in any specific market in accordance with Article 67 may be subject, as appropriate, to any of the obligations referred to in Articles 69 to 74 or any other obligations authorised by the Commission pursuant to Article 68(3), where any commitments offered are insufficient to meet the objectives set out in Article 3. 4. The national regulatory authority shall monitor the implementation of the commitments offered by the undertakings that it has made binding in accordance with paragraph 2 and shall consider their extension when the period for which they are initially offered has expired. Article 79 Commitments procedure 1. Undertakings designated as having significant market power may offer to the national regulatory authority commitments regarding conditions for access, co-investment, or both, applicable to their networks in relation, inter alia, to: (a) cooperative arrangements relevant to the assessment of appropriate and proportionate obligations pursuant to Article 68; (b) co-investment in very high capacity networks pursuant to Article 76; or (c) effective and non-discriminatory access by third parties pursuant to Article 78, both during an implementation period of voluntary separation by a vertically integrated undertaking and after the proposed form of separation is implemented. The offer for commitments shall be sufficiently detailed including as to the timing and scope of their implementation and their duration, to allow the national regulatory authority to undertake its assessment pursuant to paragraph 2 of this Article. Such commitments may extend beyond the periods for carrying out market analysis provided in Article 67(5). 2. In order to assess any commitments offered by an undertaking pursuant to paragraph 1 of this Article, the national regulatory authority shall, except where such commitments clearly do not fulfil one or more relevant conditions or criteria, perform a market test, in particular on the offered terms, by conducting a public consultation of interested parties, in particular third parties which are directly affected. Potential co-investors or access seekers may provide views on the compliance of the commitments offered with the conditions provided, as applicable, in Article 68, 76 or 78 and may propose changes. As regards the commitments offered under this Article, the national regulatory authority shall, when assessing obligations pursuant to Article 68(4), have particular regard to: (a) evidence regarding the fair and reasonable character of the commitments offered; (b) the openness of the commitments to all market participants; (c) the timely availability of access under fair, reasonable and non-discriminatory conditions, including to very high capacity networks, before the launch of related retail services; and (d) the overall adequacy of the commitments offered to enable sustainable competition on downstream markets and to facilitate cooperative deployment and take-up of very high capacity networks in the interest of end-users. Taking into account all the views expressed in the consultation, and the extent to which such views are representative of different stakeholders, the national regulatory authority shall communicate to the undertaking designated as having significant market power its preliminary conclusions whether the commitments offered comply with the objectives, criteria and procedures set out in this Article and, as applicable, in Article 68, 76 or 78, and under which conditions it may consider making the commitments binding. The undertaking may revise its initial offer to take account of the preliminary conclusions of the national regulatory authority and with a view to satisfying the criteria set out in this Article and, as applicable, in Article 68, 76 or 78. 3. Without prejudice to first subparagraph of Article 76(2), the national regulatory authority may issue a decision to make the commitments binding, wholly or in part. By way of derogation from Article 67(5), the national regulatory authority may make some or all commitments binding for a specific period, which may be the entire period for which they are offered, and in the case of co-investment commitments made binding pursuant to first subparagraph of Article 76(2), it shall make them binding for a period of minimum seven years. Subject to Article 76, this Article is without prejudice to the application of the market analysis procedure pursuant to Article 67 and the imposition of obligations pursuant to Article 68. Where the national regulatory authority makes commitments binding pursuant to this Article, it shall assess under Article 68 the consequences of that decision for market development and the appropriateness of any obligation that it has imposed or would, absent those commitments, have considered imposing pursuant to that Article or Articles 69 to 74. When notifying the relevant draft measure under Article 68 in accordance with Article 32, the national regulatory authority shall accompany the notified draft measure with the commitments decision. 4. The national regulatory authority shall monitor, supervise and ensure compliance with the commitments that it has made binding in accordance with paragraph 3 of this Article in the same way in which it monitors, supervises and ensures compliance with obligations imposed under Article 68 and shall consider the extension of the period for which they have been made binding when the initial period expires. If the national regulatory authority concludes that an undertaking has not complied with the commitments that have been made binding in accordance with paragraph 3 of this Article, it may impose penalties on such undertaking in accordance with Article 29. Without prejudice to the procedure for ensuring compliance of specific obligations under Article 30, the national regulatory authority may reassess the obligations imposed in accordance with Article 68(6). Article 80 Wholesale-only undertakings 1. A national regulatory authority that designates an undertaking which is absent from any retail markets for electronic communications services as having significant market power in one or several wholesale markets in accordance with Article 67 shall consider whether that undertaking has the following characteristics: (a) all companies and business units within the undertaking, all companies that are controlled but not necessarily wholly owned by the same ultimate owner, and any shareholder capable of exercising control over the undertaking, only have activities, current and planned for the future, in wholesale markets for electronic communications services and therefore do not have activities in any retail market for electronic communications services provided to end-users in the Union; (b) the undertaking is not bound to deal with a single and separate undertaking operating downstream that is active in any retail market for electronic communications services provided to end-users, because of an exclusive agreement, or an agreement which de facto amounts to an exclusive agreement. 2. If the national regulatory authority concludes that the conditions laid down in paragraph 1 of this Article are fulfilled, it may impose on that undertaking only obligations pursuant to Articles 70 and 73 or relative to fair and reasonable pricing if justified on the basis of a market analysis including a prospective assessment of the likely behaviour of the undertaking designated as having significant market power. 3. The national regulatory authority shall review obligations imposed on the undertaking in accordance with this Article at any time if it concludes that the conditions laid down in paragraph 1 of this Article are no longer met and it shall, as appropriate, apply Articles 67 to 74. The undertakings shall, without undue delay, inform the national regulatory authority of any change of circumstance relevant to points (a) and (b) of paragraph 1 of this Article. 4. The national regulatory authority shall also review obligations imposed on the undertaking in accordance with this Article if on the basis of evidence of terms and conditions offered by the undertaking to its downstream customers, the authority concludes that competition problems have arisen or are likely to arise to the detriment of end-users which require the imposition of one or more obligations provided in Article 69, 71, 72 or 74, or the amendment of the obligations imposed in accordance with paragraph 2 of this Article. 5. The imposition of obligations and their review in accordance with this Article shall be implemented in accordance with the procedures referred to in Articles 23, 32 and 33. Article 81 Migration from legacy infrastructure 1. Undertakings which have been designated as having significant market power in one or several relevant markets in accordance with Article 67 shall notify the national regulatory authority in advance and in a timely manner when they plan to decommission or replace with a new infrastructure parts of the network, including legacy infrastructure necessary to operate a copper network, which are subject to obligations pursuant to Articles 68 to 80. 2. The national regulatory authority shall ensure that the decommissioning or replacement process includes a transparent timetable and conditions, including an appropriate notice period for transition, and establishes the availability of alternative products of at least comparable quality providing access to the upgraded network infrastructure substituting the replaced elements if necessary to safeguard competition and the rights of end-users. With regard to assets which are proposed for decommissioning or replacement, the national regulatory authority may withdraw the obligations after having ascertained that the access provider: (a) has established the appropriate conditions for migration, including making available an alternative access product of at least comparable quality as was available using the legacy infrastructure enabling the access seekers to reach the same end-users; and (b) has complied with the conditions and process notified to the national regulatory authority in accordance with this Article. Such withdrawal shall be implemented in accordance with the procedures referred to in Articles 23, 32 and 33. 3. This Article shall be without prejudice to the availability of regulated products imposed by the national regulatory authority on the upgraded network infrastructure in accordance with the procedures set out in Articles 67 and 68. Article 82 BEREC guidelines on very high capacity networks By 21 December 2020, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, issue guidelines on the criteria that a network is to fulfil in order to be considered a very high capacity network, in particular in terms of down- and uplink bandwidth, resilience, error-related parameters, and latency and its variation. The national regulatory authorities shall take those guidelines into utmost account. BEREC shall update the guidelines by 31 December 2025, and regularly thereafter. CHAPTER V Regulatory control of retail services Article 83 Regulatory control of retail services 1. Member States may ensure that national regulatory authorities impose appropriate regulatory obligations on undertakings identified as having significant market power on a given retail market in accordance with Article 63, where: (a) as a result of a market analysis carried out in accordance with Article 67, a national regulatory authority determines that a given retail market identified in accordance with Article 64 is not effectively competitive; and (b) the national regulatory authority concludes that obligations imposed under Articles 69 to 74 would not result in the achievement of the objectives set out in Article 3. 2. Obligations imposed under paragraph 1 of this Article shall be based on the nature of the problem identified and be proportionate and justified in light of the objectives laid down in Article 3. The obligations imposed may include requirements that the identified undertakings do not charge excessive prices, inhibit market entry or restrict competition by setting predatory prices, show undue preference to specific end-users or unreasonably bundle services. National regulatory authorities may apply to such undertakings appropriate retail price cap measures, measures to control individual tariffs, or measures to orient tariffs towards costs or prices on comparable markets, in order to protect end-user interests whilst promoting effective competition. 3. National regulatory authorities shall ensure that, where an undertaking is subject to retail tariff regulation or other relevant retail controls, the necessary and appropriate cost-accounting systems are implemented. National regulatory authorities may specify the format and accounting methodology to be used. Compliance with the cost-accounting system shall be verified by a qualified independent body. National regulatory authorities shall ensure that a statement concerning compliance is published annually. 4. Without prejudice to Articles 85 and 88, national regulatory authorities shall not apply retail control mechanisms under paragraph 1 of this Article to geographical or retail markets where they are satisfied that there is effective competition. PART III SERVICES TITLE I UNIVERSAL SERVICE OBLIGATIONS Article 84 Affordable universal service 1. Member States shall ensure that all consumers in their territories have access at an affordable price, in light of specific national conditions, to an available adequate broadband internet access service and to voice communications services at the quality specified in their territories, including the underlying connection, at a fixed location. 2. In addition, Member States may also ensure the affordability of the services referred to in paragraph 1 that are not provided at a fixed location where they consider this to be necessary to ensure consumers\u2019 full social and economic participation in society. 3. Each Member State shall, in light of national conditions and the minimum bandwidth enjoyed by the majority of consumers within the territory of that Member State, and taking into account the BEREC report on best practices, define the adequate broadband internet access service for the purposes of paragraph 1 with a view to ensuring the bandwidth necessary for social and economic participation in society. The adequate broadband internet access service shall be capable of delivering the bandwidth necessary for supporting at least the minimum set of services set out in Annex V. By 21 June 2020, BEREC shall, in order to contribute towards a consistent application of this Article, after consulting stakeholders and in close cooperation with the Commission, taking into account available Commission (Eurostat) data, draw up a report on Member States\u2019 best practices to support the defining of adequate broadband internet access service pursuant to the first subparagraph. That report shall be updated regularly to reflect technological advances and changes in consumer usage patterns. 4. When a consumer so requests, the connection referred to in paragraph 1 and, where applicable, in paragraph 2 may be limited to support voice communications services. 5. Member States may extend the scope of application of this Article to end-users that are microenterprises and small and medium-sized enterprises and not-for-profit organisations. Article 85 Provision of affordable universal service 1. National regulatory authorities in coordination with other competent authorities shall monitor the evolution and level of retail prices of the services referred to in Article 84(1) available on the market, in particular in relation to national prices and national consumer income. 2. Where Member States establish that, in light of national conditions, retail prices for the services referred to in Article 84(1) are not affordable, because consumers with a low income or special social needs are prevented from accessing such services, they shall take measures to ensure affordability for such consumers of adequate broadband internet access service and voice communications services at least at a fixed location. To that end, Member States may ensure that support is provided to such consumers for communication purposes or require providers of such services to offer to those consumers tariff options or packages different from those provided under normal commercial conditions, or both. For that purpose, Member States may require such providers to apply common tariffs, including geographic averaging, throughout the territory. In exceptional circumstances, in particular where the imposition of obligations under the second subparagraph of this paragraph on all providers would result in a demonstrated excessive administrative or financial burden for providers or the Member State, a Member State may, on an exceptional basis, decide to impose the obligation to offer those specific tariff options or packages only on designated undertakings. Article 86 shall apply to such designations mutatis mutandis. Where a Member State designates undertakings, it shall ensure that all consumers with a low-income or special social needs benefit from a choice of undertakings offering tariff options addressing their needs, unless ensuring such choice is impossible or would create an excessive additional organisational or financial burden. Member States shall ensure that consumers entitled to such tariff options or packages have a right to conclude a contract either with a provider of the services referred to in Article 84(1), or with an undertaking designated in accordance with this paragraph, and that their number remains available to them for an adequate period and unwarranted disconnection of the service is avoided. 3. Member States shall ensure that undertakings which provide tariff options or packages to consumers with a low income or special social needs pursuant to paragraph 2 keep the national regulatory and other competent authorities informed of the details of such offers. National regulatory authorities in coordination with other competent authorities shall ensure that the conditions under which undertakings provide tariff options or packages pursuant to paragraph 2 are fully transparent and are published and applied in accordance with the principle of non-discrimination. National regulatory authorities in coordination with other competent authorities may require such tariff options or packages to be modified or withdrawn. 4. Member States shall ensure, in light of national conditions, that support is provided, as appropriate, to consumers with disabilities, and that other specific measures are taken, where appropriate, with a view to ensuring that related terminal equipment, and specific equipment and specific services that enhance equivalent access, including where necessary total conversation services and relay services, are available and affordable. 5. When applying this Article, Member States shall seek to minimise market distortions. 6. Member States may extend the scope of application of this Article to end-users that are microenterprises and small and medium-sized enterprises and not-for-profit organisations. Article 86 Availability of universal service 1. Where a Member State has established, taking into account the results, where available, of the geographical survey conducted in accordance with Article 22(1), and any additional evidence where necessary, that the availability at a fixed location of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services cannot be ensured under normal commercial circumstances or through other potential public policy tools in its national territory or different parts thereof, it may impose appropriate universal service obligations to meet all reasonable requests by end-users for accessing those services in the relevant parts of its territory. 2. Member States shall determine the most efficient and appropriate approach for ensuring the availability at a fixed location of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services, whilst respecting the principles of objectivity, transparency, non-discrimination and proportionality. Member States shall seek to minimise market distortions, in particular the provision of services at prices or subject to other terms and conditions which depart from normal commercial conditions, whilst safeguarding the public interest. 3. In particular, where Member States decide to impose obligations to ensure for end-users the availability at a fixed location of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services, they may designate one or more undertakings to guarantee such availability throughout the national territory. Member States may designate different undertakings or sets of undertakings to provide an adequate broadband internet access service and voice communications services at a fixed location or to cover different parts of the national territory. 4. When Member States designate undertakings in part or all of the national territory to ensure availability of services in accordance with paragraph 3 of this Article, they shall use an efficient, objective, transparent and non-discriminatory designation mechanism, whereby no undertaking is a priori excluded from being designated. Such designation methods shall ensure that an adequate broadband internet access service and voice communications services at a fixed location are provided in a cost-effective manner and may be used as a means of determining the net cost of the universal service obligations in accordance with Article 89. 5. When an undertaking designated in accordance with paragraph 3 of this Article intends to dispose of a substantial part or all of its local access network assets to a separate legal entity under different ownership, it shall inform the national regulatory or other competent authority in advance and in a timely manner, in order to allow that authority to assess the effect of the intended transaction on the provision at a fixed location of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services. The national regulatory or other competent authority may impose, amend or withdraw specific obligations in accordance with Article 13(2). Article 87 Status of the existing universal service Member States may continue to ensure the availability or affordability of other services than adequate broadband internet access service as defined in accordance with Article 84(3) and voice communications services at a fixed location that were in force on 20 December 2018, if the need for such services is established in light of national circumstances. When Member States designate undertakings in part or all of the national territory for the provision of those services, Article 86 shall apply. Financing of those obligations shall comply with Article 90. Member States shall review the obligations imposed pursuant to this Article by 21 December 2021, and every three years thereafter. Article 88 Control of expenditure 1. Member States shall ensure that, in providing facilities and services additional to those referred to in Article 84, providers of an adequate broadband internet access service and of voice communications services in accordance with Articles 84 to 87 establish terms and conditions in such a way that the end-user is not obliged to pay for facilities or services which are not necessary or not required for the service requested. 2. Member States shall ensure that the providers of an adequate broadband internet access service and of voice communications services referred to in Article 84 that provide services pursuant to Article 85 offer the specific facilities and services set out in Part A of Annex VI as applicable, in order that consumers can monitor and control expenditure. Member States shall ensure that such providers put in place a system to avoid unwarranted disconnection of voice communications services or of an adequate broadband internet access service with regard to consumers as referred to in Article 85, including an appropriate mechanism to check continued interest in using the service. Member States may extend the scope of application of this paragraph to end-users that are microenterprises and small and medium-sized enterprises and not-for-profit organisations. 3. Each Member State shall ensure that the competent authority is able to waive the requirements of paragraph 2 in all or part of its national territory if the competent authority is satisfied that the facility is widely available. Article 89 Cost of universal service obligations 1. Where national regulatory authorities consider that the provision of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services as set out in Articles 84, 85 and 86 or the continuation of the existing universal service as set out in Article 87 may represent an unfair burden on providers of such services that request compensation, national regulatory authorities shall calculate the net costs of such provision. For that purpose, national regulatory authorities shall: (a) calculate the net cost of the universal service obligations, taking into account any market benefit which accrues to a provider of an adequate broadband internet access service as defined in accordance with Article 84(3) and voice communications services as set out in Articles 84, 85 and 86 or the continuation of the existing universal service as set out in Article 87, in accordance with Annex VII; or (b) make use of the net costs of providing universal service identified by a designation mechanism in accordance with Article 86(4). 2. The accounts and other information serving as the basis for the calculation of the net cost of universal service obligations under point (a) of the second subparagraph of paragraph 1 shall be audited or verified by the national regulatory authority or a body independent of the relevant parties and approved by the national regulatory authority. The results of the cost calculation and the conclusions of the audit shall be publicly available. Article 90 Financing of universal service obligations 1. Where, on the basis of the net cost calculation referred to in Article 89, national regulatory authorities find that a provider is subject to an unfair burden, Member States shall, upon request from the provider concerned, decide to do one or both of the following: (a) introduce a mechanism to compensate that provider for the determined net costs under transparent conditions from public funds; (b) share the net cost of universal service obligations between providers of electronic communications networks and services. 2. Where the net cost is shared in accordance with point (b) of paragraph 1 of this Article, Member States shall establish a sharing mechanism administered by the national regulatory authority or a body independent from the beneficiaries under the supervision of the national regulatory authority. Only the net cost, as determined in accordance with Article 89, of the obligations laid down in Articles 84 to 87 may be financed. The sharing mechanism shall respect the principles of transparency, least market distortion, non-discrimination and proportionality, in accordance with the principles set out in Part B of Annex VII. Member States may choose not to require contributions from undertakings the national turnover of which is less than a set limit. Any charges related to the sharing of the cost of universal service obligations shall be unbundled and identified separately for each undertaking. Such charges shall not be imposed on, or collected from, undertakings that are not providing services in the territory of the Member State that has established the sharing mechanism. Article 91 Transparency 1. Where the net cost of universal service obligations is to be calculated in accordance with Article 89, national regulatory authorities shall ensure that the principles for net cost calculation, including the details of methodology to be used are publicly available. Where a mechanism for sharing the net cost of universal service obligations as referred to in Article 90(2) is established, national regulatory authorities shall ensure that the principles for cost sharing and compensation of the net cost are publicly available. 2. Subject to Union and national rules on commercial confidentiality, national regulatory authorities shall publish an annual report providing the details of calculated cost of universal service obligations, identifying the contributions made by all undertakings involved, including any market benefits that may have accrued to the undertakings pursuant to universal service obligations laid down in Articles 84 to 87. Article 92 Additional mandatory services Member States may decide to make services additional to those included in the universal service obligations referred to in Articles 84 to 87, publicly available on their territories. In such cases, no compensation mechanism involving specific undertakings shall be imposed. TITLE II NUMBERING RESOURCES Article 93 Numbering resources 1. Member States shall ensure that national regulatory or other competent authorities control the granting of rights of use for all national numbering resources and the management of the national numbering plans and that they provide adequate numbering resources for the provision of publicly available electronic communications services. Member States shall ensure that objective, transparent and non-discriminatory procedures for granting rights of use for national numbering resources are established. 2. National regulatory or other competent authorities may also grant rights of use for numbering resources from the national numbering plans for the provision of specific services to undertakings other than providers of electronic communications networks or services, provided that adequate numbering resources are made available to satisfy current and foreseeable future demand. Those undertakings shall demonstrate their ability to manage the numbering resources and to comply with any relevant requirements set out pursuant to Article 94. National regulatory or other competent authorities may suspend the further granting of rights of use for numbering resources to such undertakings if it is demonstrated that there is a risk of exhaustion of numbering resources. By 21 June 2020, in order to contribute to the consistent application of this paragraph, BEREC shall adopt, after consulting stakeholders and in close cooperation with the Commission, guidelines on common criteria for the assessment of the ability to manage numbering resources and of the risk of exhaustion of numbering resources. 3. National regulatory or other competent authorities shall ensure that national numbering plans and procedures are applied in a manner that gives equal treatment to all providers of publicly available electronic communications services and the undertakings eligible in accordance with paragraph 2. In particular, Member States shall ensure that an undertaking to which the right of use for numbering resources has been granted does not discriminate against other providers of electronic communications services as regards the numbering resources used to give access to their services. 4. Each Member State shall ensure that national regulatory or other competent authorities make available a range of non-geographic numbers which may be used for the provision of electronic communications services other than interpersonal communications services, throughout the territory of the Union, without prejudice to Regulation (EU) No 531/2012 and Article 97(2) of this Directive. Where rights of use for numbering resources have been granted in accordance with paragraph 2 of this Article to undertakings other than providers of electronic communications networks or services, this paragraph shall apply to the specific services for the provision of which the rights of use have been granted. National regulatory or other competent authorities shall ensure that the conditions listed in Part E of Annex I that may be attached to the rights of use for numbering resources used for the provision of services outside the Member State of the country code, and their enforcement, are as stringent as the conditions and enforcement applicable to services provided within the Member State of the country code, in accordance with this Directive. National regulatory or other competent authorities shall also ensure in accordance with Article 94(6) that providers using numbering resources of their country code in other Member States comply with consumer protection and other national rules related to the use of numbering resources applicable in those Member States where the numbering resources are used. This obligation is without prejudice to the enforcement powers of the competent authorities of those Member States. BEREC shall assist national regulatory or other competent authorities, at their request, in coordinating their activities to ensure the efficient management of numbering resources with a right of extraterritorial use within the Union. In order to facilitate the monitoring by the national regulatory or other competent authorities of compliance with the requirements of this paragraph, BEREC shall establish a database on the numbering resources with a right of extraterritorial use within the Union. For this purpose, national regulatory or other competent authorities shall transmit the relevant information to BEREC. Where numbering resources with a right of extraterritorial use within the Union are not granted by the national regulatory authority, the competent authority responsible for their granting or management shall consult the national regulatory authority. 5. Member States shall ensure that the \u201800\u2019 code is the standard international access code. Special arrangements for the use of number-based interpersonal communications services between locations adjacent to one another across borders between Member States may be established or continued. Member States may agree to share a common numbering plan for all or specific categories of numbers. End-users affected by such arrangements or agreements shall be fully informed. 6. Without prejudice to Article 106, Member States shall promote over-the-air provisioning, where technically feasible, to facilitate switching of providers of electronic communications networks or services by end-users, in particular providers and end-users of machine-to-machine services. 7. Member States shall ensure that the national numbering plans, and all subsequent additions or amendments thereto, are published, subject only to limitations imposed on the grounds of national security. 8. Member States shall support the harmonisation of specific numbers or numbering ranges within the Union where it promotes both the functioning of the internal market and the development of pan-European services. Where necessary to address unmet cross-border or pan-European demand for numbering resources, the Commission shall, taking utmost account of the opinion of BEREC, adopt implementing acts harmonising specific numbers or numbering ranges. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). Article 94 Procedure for granting of rights of use for numbering resources 1. Where it is necessary to grant individual rights of use for numbering resources, national regulatory or other competent authorities shall grant such rights, upon request, to any undertaking for the provision of electronic communications networks or services covered by a general authorisation referred to in Article 12, subject to Article 13 and to point (c) of Article 21(1) and to any other rules ensuring the efficient use of those numbering resources in accordance with this Directive. 2. The rights of use for numbering resources shall be granted through open, objective, transparent, non-discriminatory and proportionate procedures. When granting rights of use for numbering resources, national regulatory or other competent authorities shall specify whether those rights can be transferred by the holder of the rights, and under which conditions. Where national regulatory or other competent authorities grant rights of use for numbering resources for a limited period, the duration of that period shall be appropriate for the service concerned with a view to the objective pursued, taking due account of the need to allow for an appropriate period for investment amortisation. 3. National regulatory or other competent authorities shall take decisions on the granting of rights of use for numbering resources as soon as possible after receipt of the complete application and within three weeks in the case of numbering resources that have been allocated for specific purposes within the national numbering plan. Such decisions shall be made public. 4. Where national regulatory or other competent authorities have determined, after consulting interested parties in accordance with Article 23, that rights of use for numbering resources of exceptional economic value are to be granted through competitive or comparative selection procedures, national regulatory or other competent authorities may extend the three-week period referred to in paragraph 3 of this Article by up to a further three weeks. 5. National regulatory or other competent authorities shall not limit the number of individual rights of use to be granted, except where this is necessary to ensure the efficient use of numbering resources. 6. Where the rights of use for numbering resources include their extraterritorial use within the Union in accordance with Article 93(4), national regulatory or other competent authorities shall attach to those rights of use specific conditions in order to ensure compliance with all the relevant national consumer protection rules and national law related to the use of numbering resources applicable in the Member States where the numbering resources are used. Upon request from a national regulatory or other competent authority of a Member State where the numbering resources are used, demonstrating a breach of relevant consumer protection rules or national laws related to the use of numbering resources of that Member State, the national regulatory or other competent authorities of the Member State where the rights of use for the numbering resources have been granted shall enforce the conditions attached under the first subparagraph of this paragraph in accordance with Article 30, including, in serious cases, by withdrawing the rights of extraterritorial use for the numbering resources granted to the undertaking concerned. BEREC shall facilitate and coordinate the exchange of information between the competent authorities of the different Member States involved and ensure the appropriate coordination of work among them. 7. This Article shall also apply where national regulatory or other competent authorities grant rights of use for numbering resources to undertakings other than providers of electronic communications networks or services in accordance with Article 93(2). Article 95 Fees for rights of use for numbering resources Member States may allow national regulatory or other competent authorities to impose fees for the rights of use for numbering resources which reflect the need to ensure the optimal use of those resources. Member States shall ensure that such fees are objectively justified, transparent, non-discriminatory and proportionate in relation to their intended purpose and shall take into account the objectives set out in Article 3. Article 96 Missing children and child helpline hotlines 1. Member States shall ensure that end-users have access free of charge to a service operating a hotline to report cases of missing children. The hotline shall be available on the number \u2018116000\u2019. 2. Member States shall ensure that end-users with disabilities are able to access services provided under the number \u2018116000\u2019 to the greatest extent possible. Measures taken to facilitate access by end-users with disabilities to such services whilst travelling in other Member States shall be based on compliance with relevant standards or specifications laid down in accordance with Article 39. 3. Member States shall take appropriate measures to ensure that the authority or undertaking to which the number \u2018116000\u2019 has been assigned allocates the necessary resources to operate the hotline. 4. Member States and the Commission shall ensure that end-users are adequately informed of the existence and use of services provided under the numbers \u2018116000\u2019 and, where appropriate, \u2018116111\u2019. Article 97 Access to numbers and services 1. Member States shall ensure that, where economically feasible, except where a called end-user has chosen for commercial reasons to limit access by calling parties located in specific geographical areas, national regulatory or other competent authorities take all necessary steps to ensure that end-users are able to: (a) access and use services using non-geographic numbers within the Union; and (b) access all numbers provided in the Union, regardless of the technology and devices used by the operator, including those in the national numbering plans of Member States and Universal International Freephone Numbers (UIFN). 2. Member States shall ensure that national regulatory or other competent authorities are able to require providers of public electronic communications networks or publicly available electronic communications services to block, on a case-by-case basis, access to numbers or services where this is justified by reasons of fraud or misuse and to require that in such cases providers of electronic communications services withhold relevant interconnection or other service revenues. TITLE III END-USER RIGHTS Article 98 Exemption of certain microenterprises With the exception of Articles 99 and 100, this Title shall not apply to microenterprises providing number-independent interpersonal communications services unless they also provide other electronic communications services. Member States shall ensure that end-users are informed of an exemption under the first paragraph before concluding a contract with a microenterprise benefitting from such an exemption. Article 99 Non-discrimination Providers of electronic communications networks or services shall not apply any different requirements or general conditions of access to, or use of, networks or services to end-users, for reasons related to the end-user\u2019s nationality, place of residence or place of establishment, unless such different treatment is objectively justified. Article 100 Fundamental rights safeguard 1. National measures regarding end-users\u2019 access to, or use of, services and applications through electronic communications networks shall respect the Charter of Fundamental Rights of the Union (the \u2018Charter\u2019) and general principles of Union law. 2. Any measure regarding end-users\u2019 access to, or use of, services and applications through electronic communications networks liable to limit the exercise of the rights or freedoms recognised by the Charter shall be imposed only if it is provided for by law and respects those rights or freedoms, is proportionate, necessary, and genuinely meets general interest objectives recognised by Union law or the need to protect the rights and freedoms of others in line with Article 52(1) of the Charter and with general principles of Union law, including the right to an effective remedy and to a fair trial. Accordingly, such measures shall be taken only with due respect for the principle of the presumption of innocence and the right to privacy. A prior, fair and impartial procedure shall be guaranteed, including the right to be heard of the person or persons concerned, subject to the need for appropriate conditions and procedural arrangements in duly substantiated cases of urgency in accordance with the Charter. Article 101 Level of harmonisation 1. Member States shall not maintain or introduce in their national law end-user protection provisions diverging from Articles 102 to 115, including more, or less, stringent provisions to ensure a different level of protection, unless otherwise provided for in this Title. 2. Until 21 December 2021, Member States may continue to apply more stringent national consumer protection provisions diverging from those laid down in Articles 102 to 115, provided that those provisions were in force on 20 December 2018 and any restrictions to the functioning of the internal market resulting therefrom are proportionate to the objective of consumer protection. Member States shall notify the Commission by 21 December 2019 of any national provisions to be applied on the basis of this paragraph. Article 102 Information requirements for contracts 1. Before a consumer is bound by a contract or any corresponding offer, providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services shall provide the information referred to in Articles 5 and 6 of Directive 2011/83/EU, and, in addition, the information listed in Annex VIII of this Directive to the extent that that information relates to a service they provide. The information shall be provided in a clear and comprehensible manner on a durable medium as defined in point (10) of Article 2 of Directive 2011/83/EU or, where provision on a durable medium is not feasible, in an easily downloadable document made available by the provider. The provider shall expressly draw the consumer\u2019s attention to the availability of that document and the importance of downloading it for the purposes of documentation, future reference and unchanged reproduction. The information shall, upon request, be provided in an accessible format for end-users with disabilities in accordance with Union law harmonising accessibility requirements for products and services. 2. The information referred to in paragraphs 1, 3 and 5 shall also be provided to end-users that are microenterprises or small enterprises or not-for-profit organisations, unless they have explicitly agreed to waive all or parts of those provisions. 3. Providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services shall provide consumers with a concise and easily readable contract summary. That summary shall identify the main elements of the information requirements in accordance with paragraph 1. Those main elements shall include at least: (a) the name, address and contact information of the provider and, if different, the contact information for any complaint; (b) the main characteristics of each service provided; (c) the respective prices for activating the electronic communications service and for any recurring or consumption-related charges, where the service is provided for direct monetary payment; (d) the duration of the contract and the conditions for its renewal and termination; (e) the extent to which the products and services are designed for end-users with disabilities; (f) with respect to internet access services, a summary of the information required pursuant to points (d) and (e) of Article 4(1) of Regulation (EU) 2015/2120. By 21 December 2019, the Commission shall, after consulting BEREC, adopt implementing acts specifying a contract summary template to be used by the providers to fulfil their obligations under this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). Providers subject to the obligations under paragraph 1 shall duly complete that contract summary template with the required information and provide the contract summary free of charge to consumers, prior to the conclusion of the contract, including distance contracts. Where, for objective technical reasons, it is impossible to provide the contract summary at that moment, it shall be provided without undue delay thereafter, and the contract shall become effective when the consumer has confirmed his or her agreement after reception of the contract summary. 4. The information referred to in paragraphs 1 and 3 shall become an integral part of the contract and shall not be altered unless the contracting parties expressly agree otherwise. 5. Where internet access services or publicly available interpersonal communications services are billed on the basis of either time or volume consumption, their providers shall offer consumers the facility to monitor and control the usage of each of those services. This facility shall include access to timely information on the level of consumption of services included in a tariff plan. In particular, providers shall notify consumers before any consumption limit, as established by competent authorities in coordination, where relevant, with national regulatory authorities, included in their tariff plan, is reached and when a service included in their tariff plan is fully consumed. 6. Member States may maintain or introduce in their national law provisions requiring providers to provide additional information on the consumption level and temporarily prevent further use of the relevant service in excess of a financial or volume limit determined by the competent authority. 7. Member States shall remain free to maintain or introduce in their national law provisions relating to aspects not regulated by this Article, in particular in order to address newly emerging issues. Article 103 Transparency, comparison of offers and publication of information 1. Competent authorities in coordination, where relevant, with national regulatory authorities shall ensure that, where providers of internet access services or publicly available interpersonal communication services make the provision of those services subject to terms and conditions, the information referred to in Annex IX is published in a clear, comprehensive, machine-readable manner and in an accessible format for end-users with disabilities in accordance with Union law harmonising accessibility requirements for products and services, by all such providers, or by the competent authority itself in coordination, where relevant, with the national regulatory authority. Such information shall be updated regularly. Competent authorities in coordination, where relevant, with national regulatory authorities may specify additional requirements regarding the form in which such information is to be published. That information shall, on request, be supplied to the competent authority and, where relevant, to the national regulatory authority before its publication. 2. Competent authorities shall, in coordination, where relevant, with national regulatory authorities, ensure that end-users have access free of charge to at least one independent comparison tool which enables them to compare and evaluate different internet access services and publicly available number-based interpersonal communications services, and, where applicable, publicly available number-independent interpersonal communications services, with regard to: (a) prices and tariffs of services provided against recurring or consumption-based direct monetary payments; and (b) the quality of service performance, where minimum quality of service is offered or the undertaking is required to publish such information pursuant to Article 104. 3. The comparison tool referred to in paragraph 2 shall: (a) be operationally independent from the providers of such services, thereby ensuring that those providers are given equal treatment in search results; (b) clearly disclose the owners and operators of the comparison tool; (c) set out clear and objective criteria on which the comparison is to be based; (d) use plain and unambiguous language; (e) provide accurate and up-to-date information and state the time of the last update; (f) be open to any provider of internet access services or publicly available interpersonal communications services making available the relevant information, and include a broad range of offers covering a significant part of the market and, where the information presented is not a complete overview of the market, a clear statement to that effect, before displaying results; (g) provide an effective procedure to report incorrect information; (h) include the possibility to compare prices, tariffs and quality of service performance between offers available to consumers and, if required by Member States, between those offers and the standard offers publicly available to other end-users. Comparison tools fulfilling the requirements in points (a) to (h) shall, upon request by the provider of the tool, be certified by competent authorities in coordination, where relevant, with national regulatory authorities. Third parties shall have a right to use, free of charge and in open data formats, the information published by providers of internet access services or publicly available interpersonal communications services, for the purposes of making available such independent comparison tools. 4. Member States may require that providers of internet access services or publicly available number-based interpersonal communications services, or both, distribute public interest information free of charge to existing and new end-users, where appropriate, by the means that they ordinarily use in their communications with end-users. In such a case, that public interest information shall be provided by the relevant public authorities in a standardised format and shall, inter alia, cover the following topics: (a) the most common uses of internet access services and publicly available number-based interpersonal communications services to engage in unlawful activities or to disseminate harmful content, in particular where it may prejudice respect for the rights and freedoms of others, including infringements of data protection rights, copyright and related rights, and their legal consequences; and (b) the means of protection against risks to personal security, privacy and personal data when using internet access services and publicly available number-based interpersonal communications services. Article 104 Quality of service related to internet access services and publicly available interpersonal communications services 1. National regulatory authorities in coordination with other competent authorities may require providers of internet access services and of publicly available interpersonal communications services to publish comprehensive, comparable, reliable, user-friendly and up-to-date information for end-users on the quality of their services, to the extent that they control at least some elements of the network either directly or by virtue of a service level agreement to that effect, and on measures taken to ensure equivalence in access for end-users with disabilities. National regulatory authorities in coordination with other competent authorities may also require providers of publicly available interpersonal communication services to inform consumers if the quality of the services they provide depends on any external factors, such as control of signal transmission or network connectivity. That information shall, on request, be supplied to the national regulatory and, where relevant, to other competent authorities before its publication. The measures to ensure quality of service shall comply with Regulation (EU) 2015/2120. 2. National regulatory authorities in coordination with other competent authorities shall specify, taking utmost account of BEREC guidelines, the quality of service parameters to be measured, the applicable measurement methods, and the content, form and manner of the information to be published, including possible quality certification mechanisms. Where appropriate, the parameters, definitions and measurement methods set out in Annex X shall be used. By 21 June 2020, in order to contribute to a consistent application of this paragraph and of Annex X, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, adopt guidelines detailing the relevant quality of service parameters, including parameters relevant for end-users with disabilities, the applicable measurement methods, the content and format of publication of the information, and quality certification mechanisms. Article 105 Contract duration and termination 1. Member States shall ensure that conditions and procedures for contract termination do not act as a disincentive to changing service provider and that contracts concluded between consumers and providers of publicly available electronic communications services other than number-independent interpersonal communications services and other than transmission services used for the provision of machine-to-machine services, do not mandate a commitment period longer than 24 months. Member States may adopt or maintain provisions which mandate shorter maximum contractual commitment periods. This paragraph shall not apply to the duration of an instalment contract where the consumer has agreed in a separate contract to instalment payments exclusively for deployment of a physical connection, in particular to very high capacity networks. An instalment contract for the deployment of a physical connection shall not include terminal equipment, such as a router or modem, and shall not preclude consumers from exercising their rights under this Article. 2. Paragraph 1 shall also apply to end-users that are microenterprises, small enterprises or not-for-profit organisations, unless they have explicitly agreed to waive those provisions. 3. Where a contract or national law provides for automatic prolongation of a fixed duration contract for electronic communications services other than number-independent interpersonal communications services and other than transmission services used for the provision of machine-to-machine services, Member States shall ensure that, after such prolongation, end-users are entitled to terminate the contract at any time with a maximum one-month notice period, as determined by Member States, and without incurring any costs except the charges for receiving the service during the notice period. Before the contract is automatically prolonged, providers shall inform end-users, in a prominent and timely manner and on a durable medium, of the end of the contractual commitment and of the means by which to terminate the contract. In addition, and at the same time, providers shall give end-users best tariff advice relating to their services. Providers shall provide end-users with best tariff information at least annually. 4. End-users shall have the right to terminate their contract without incurring any further costs upon notice of changes in the contractual conditions proposed by the provider of publicly available electronic communications services other than number-independent interpersonal communications services, unless the proposed changes are exclusively to the benefit of the end-user, are of a purely administrative nature and have no negative effect on the end-user, or are directly imposed by Union or national law. Providers shall notify end-users at least one month in advance of any change in the contractual conditions, and shall simultaneously inform them of their right to terminate the contract without incurring any further costs if they do not accept the new conditions. The right to terminate the contract shall be exercisable within one month after notification. Member States may extend that period by up to three months. Member States shall ensure that notification is made in a clear and comprehensible manner on a durable medium. 5. Any significant continued or frequently recurring discrepancy between the actual performance of an electronic communications service, other than an internet access service or a number-independent interpersonal communications service, and the performance indicated in the contract shall be considered to be a basis for triggering the remedies available to the consumer in accordance with national law, including the right to terminate the contract free of cost. 6. Where an end-user has the right to terminate a contract for a publicly available electronic communications service, other than a number-independent interpersonal communications service, before the end of the agreed contract period pursuant to this Directive or to other provisions of Union or national law, no compensation shall be due by the end-user other than for retained subsidised terminal equipment. Where the end-user chooses to retain terminal equipment bundled at the moment of the contract conclusion, any compensation due shall not exceed its pro rata temporis value as agreed at the moment of the conclusion of the contract or the remaining part of the service fee until the end of the contract, whichever is the smaller. Member States may determine other methods to calculate the compensation rate, provided that such methods do not result in a level of compensation exceeding that calculated in accordance with the second subparagraph. The provider shall lift any condition on the use of that terminal equipment on other networks free of charge at a time specified by Member States and at the latest upon payment of the compensation. 7. As far as transmission services used for machine-to-machine services are concerned, the rights mentioned in paragraphs 4 and 6 shall benefit only end-users that are consumers, microenterprises, small enterprises or not-for-profit organisations. Article 106 Provider switching and number portability 1. In the case of switching between providers of internet access services, the providers concerned shall provide the end-user with adequate information before and during the switching process and ensure continuity of the internet access service, unless technically not feasible. The receiving provider shall ensure that the activation of the internet access service occurs within the shortest possible time on the date and within the timeframe expressly agreed with the end-user. The transferring provider shall continue to provide its internet access service on the same terms until the receiving provider activates its internet access service. Loss of service during the switching process shall not exceed one working day. National regulatory authorities shall ensure the efficiency and simplicity of the switching process for the end-user. 2. Member States shall ensure that all end-users with numbers from the national numbering plan have the right to retain their numbers, upon request, independently of the undertaking providing the service, in accordance with Part C of Annex VI. 3. Where an end-user terminates a contract, Member States shall ensure that the end-user can retain the right to port a number from the national numbering plan to another provider for a minimum of one month after the date of termination, unless that right is renounced by the end-user. 4. National regulatory authorities shall ensure that pricing among providers related to the provision of number portability is cost-oriented, and that no direct charges are applied to end-users. 5. The porting of numbers and their subsequent activation shall be carried out within the shortest possible time on the date explicitly agreed with the end-user. In any case, end-users who have concluded an agreement to port a number to a new provider shall have that number activated within one working day from the date agreed with the end-user. In the case of failure of the porting process, the transferring provider shall reactivate the number and related services of the end-user until the porting is successful. The transferring provider shall continue to provide its services on the same terms and conditions until the services of the receiving provider are activated. In any event, the loss of service during the process of provider switching and the porting of numbers shall not exceed one working day. Operators whose access networks or facilities are used by either the transferring or the receiving provider, or both, shall ensure that there is no loss of service that would delay the switching and porting process. 6. The receiving provider shall lead the switching and porting processes set out in paragraphs 1 and 5 and both the receiving and transferring providers shall cooperate in good faith. They shall not delay or abuse the switching and porting processes, nor shall they port numbers or switch end-users without the end-users\u2019 explicit consent. The end-users\u2019 contracts with the transferring provider shall be terminated automatically upon conclusion of the switching process. National regulatory authorities may establish the details of the switching and porting processes, taking into account national provisions on contracts, technical feasibility and the need to maintain continuity of service to the end-users. This shall include, where technically feasible, a requirement for the porting to be completed through over-the-air provisioning, unless an end-user requests otherwise. National regulatory authorities shall also take appropriate measures ensuring that end-users are adequately informed and protected throughout the switching and porting processes and are not switched to another provider without their consent. Transferring providers shall refund, upon request, any remaining credit to the consumers using pre-paid services. Refund may be subject to a fee only if provided for in the contract. Any such fee shall be proportionate and commensurate with the actual costs incurred by the transferring provider in offering the refund. 7. Member States shall lay down rules on penalties in the case of the failure of a provider to comply with the obligations laid down in this Article, including delays in, or abuses of, porting by, or on behalf of, a provider. 8. Member States shall lay down rules on the compensation of end-users by their providers in an easy and timely manner in the case of the failure of a provider to comply with the obligations laid down in this Article, as well as in the case of delays in, or abuses of, porting and switching processes, and missed service and installation appointments. 9. In addition to the information required under Annex VIII, Member States shall ensure that end-users are adequately informed about the existence of the rights to compensation referred to in paragraphs 7 and 8. Article 107 Bundled offers 1. If a bundle of services or a bundle of services and terminal equipment offered to a consumer comprises at least an internet access service or a publicly available number-based interpersonal communications service, Article 102(3), Article 103(1), Article 105 and Article 106(1) shall apply to all elements of the bundle including, mutatis mutandis, those not otherwise covered by those provisions. 2. Where the consumer has, under Union law, or national law in accordance with Union law, a right to terminate any element of the bundle as referred to in paragraph 1 before the end of the agreed contract term because of a lack of conformity with the contract or a failure to supply, Member States shall provide that the consumer has the right to terminate the contract with respect to all elements of the bundle. 3. Any subscription to additional services or terminal equipment provided or distributed by the same provider of internet access services or of publicly available number-based interpersonal communications services shall not extend the original duration of the contract to which such services or terminal equipment are added, unless the consumer expressly agrees otherwise when subscribing to the additional services or terminal equipment. 4. Paragraphs 1 and 3 shall also apply to end-users that are microenterprises, small enterprises, or not-for-profit organisations, unless they have explicitly agreed to waive all or parts of those provisions. 5. Member States may also apply paragraph 1 as regards other provisions laid down in this Title. Article 108 Availability of services Member States shall take all necessary measures to ensure the fullest possible availability of voice communications services and internet access services provided over public electronic communications networks in the event of catastrophic network breakdown or in cases of force majeure. Member States shall ensure that providers of voice communications services take all necessary measures to ensure uninterrupted access to emergency services and uninterrupted transmission of public warnings. Article 109 Emergency communications and the single European emergency number 1. Member States shall ensure that all end-users of the services referred to in paragraph 2, including users of public pay telephones, are able to access the emergency services through emergency communications free of charge and without having to use any means of payment, by using the single European emergency number \u2018112\u2019 and any national emergency number specified by Member States. Member States shall promote the access to emergency services through the single European emergency number \u2018112\u2019 from electronic communications networks which are not publicly available but which enable calls to public networks, in particular when the undertaking responsible for that network does not provide an alternative and easy access to an emergency service. 2. Member States shall, after consulting national regulatory authorities and emergency services and providers of electronic communications services, ensure that providers of publicly available number-based interpersonal communications services, where those services allow end-users to originate calls to a number in a national or international numbering plan, provide access to emergency services through emergency communications to the most appropriate PSAP. 3. Member States shall ensure that all emergency communications to the single European emergency number \u2018112\u2019 are appropriately answered and handled in the manner best suited to the national organisation of emergency systems. Such emergency communications shall be answered and handled at least as expeditiously and effectively as emergency communications to the national emergency number or numbers, where those continue to be in use. 4. By 21 December 2020 and every two years thereafter, the Commission shall submit a report to the European Parliament and to the Council on the effectiveness of the implementation of the single European emergency number \u2018112\u2019. 5. Member States shall ensure that access for end-users with disabilities to emergency services is available through emergency communications and is equivalent to that enjoyed by other end-users, in accordance with Union law harmonising accessibility requirements for products and services. The Commission and the national regulatory or other competent authorities shall take appropriate measures to ensure that, whilst travelling in another Member State, end-users with disabilities can access emergency services on an equivalent basis with other end-users, where feasible without any pre-registration. Those measures shall seek to ensure interoperability across Member States and shall be based, to the greatest extent possible, on European standards or specifications laid down in accordance with Article 39. Such measures shall not prevent Member States from adopting additional requirements in order to pursue the objectives set out in this Article. 6. Member States shall ensure that caller location information is made available to the most appropriate PSAP without delay after the emergency communication is set up. This shall include network-based location information and, where available, handset-derived caller location information. Member States shall ensure that the establishment and the transmission of the caller location information are free of charge for the end-user and the PSAP with regard to all emergency communications to the single European emergency number \u2018112\u2019. Member States may extend that obligation to cover emergency communications to national emergency numbers. Competent regulatory authorities, if necessary after consulting BEREC, shall lay down criteria for the accuracy and reliability of the caller location information provided. 7. Member States shall ensure that end-users are adequately informed about the existence and the use of the single European emergency number \u2018112\u2019, as well as its accessibility features, including through initiatives specifically targeting persons travelling between Member States and end-users with disabilities. That information shall be provided in accessible formats, addressing different types of disabilities. The Commission shall support and complement Member States\u2019 action. 8. In order to ensure effective access to emergency services through emergency communications to the single European emergency number \u2018112\u2019 in the Member States, the Commission shall, after consulting BEREC, adopt delegated acts in accordance with Article 117 supplementing paragraphs 2, 5 and 6 of this Article on the measures necessary to ensure the compatibility, interoperability, quality, reliability and continuity of emergency communications in the Union with regard to caller location information solutions, access for end-users with disabilities and routing to the most appropriate PSAP. The first such delegated act shall be adopted by 21 December 2022. Those delegated acts shall be adopted without prejudice to, and shall have no impact on, the organisation of emergency services, which remains in the exclusive competence of Member States. BEREC shall maintain a database of E.164 numbers of Member State emergency services to ensure that they are able to contact each other from one Member State to another, if such a database is not maintained by another organisation. Article 110 Public warning system 1. By 21 June 2022, Member States shall ensure that, when public warning systems regarding imminent or developing major emergencies and disasters are in place, public warnings are transmitted by providers of mobile number-based interpersonal communications services to the end-users concerned. 2. Notwithstanding paragraph 1, Member States may determine that public warnings be transmitted through publicly available electronic communications services other than those referred to in paragraph 1, and other than broadcasting services, or through a mobile application relying on an internet access service, provided that the effectiveness of the public warning system is equivalent in terms of coverage and capacity to reach end-users, including those only temporarily present in the area concerned, taking utmost account of BEREC guidelines. Public warnings shall be easy for end-users to receive. By 21 June 2020, and after consulting the authorities in charge of PSAPs, BEREC shall publish guidelines on how to assess whether the effectiveness of public warning systems under this paragraph is equivalent to the effectiveness of those under paragraph 1. Article 111 Equivalent access and choice for end-users with disabilities 1. Member States shall ensure that the competent authorities specify requirements to be met by providers of publicly available electronic communications services to ensure that end-users with disabilities: (a) have access to electronic communications services, including the related contractual information provided pursuant to Article 102, equivalent to that enjoyed by the majority of end-users; and (b) benefit from the choice of undertakings and services available to the majority of end-users. 2. In taking the measures referred to in paragraph 1 of this Article, Member States shall encourage compliance with the relevant standards or specifications laid down in accordance with Article 39. Article 112 Directory enquiry services 1. Member States shall ensure that all providers of number-based interpersonal communications services which attribute numbers from a numbering plan meet all reasonable requests to make available, for the purposes of the provision of publicly available directory enquiry services and directories, the relevant information in an agreed format, on terms which are fair, objective, cost oriented and non-discriminatory. 2. National regulatory authorities shall be empowered to impose obligations and conditions on undertakings that control access to end-users, for the provision of directory enquiry services, in accordance with Article 61. Such obligations and conditions shall be objective, equitable, non-discriminatory and transparent. 3. Member States shall not maintain any regulatory restrictions which prevent end-users in one Member State from accessing directly the directory enquiry service in another Member State by voice call or SMS, and shall take measures to ensure such access in accordance with Article 97. 4. This Article shall apply subject to the requirements of Union law on the protection of personal data and privacy and, in particular, Article 12 of Directive 2002/58/EC. Article 113 Interoperability of car radio and consumer radio receivers and consumer digital television equipment 1. Member States shall ensure the interoperability of car radio receivers and consumer digital television equipment in accordance with Annex XI. 2. Member States may adopt measures to ensure the interoperability of other consumer radio receivers, while limiting the impact on the market for low-value radio broadcast receivers and ensuring that such measures are not applied to products where a radio receiver is purely ancillary, such as smartphones, and to equipment used by radio amateurs. 3. Member States shall encourage providers of digital television services to ensure, where appropriate, that the digital television equipment that they provide to their end-users is interoperable so that, where technically feasible, the digital television equipment is reusable with other providers of digital television services. Without prejudice to Article 5(2) of Directive 2012/19/EU of the European Parliament and of the Council (47), Member States shall ensure that, upon termination of their contract, end-users have the possibility to return the digital television equipment through a free and easy process, unless the provider demonstrates that it is fully interoperable with the digital television services of other providers, including those to which the end-user has switched. Digital television equipment which complies with harmonised standards the references of which have been published in the Official Journal of the European Union, or with parts thereof, shall be considered to comply with the requirement of interoperability set out in the second subparagraph covered by those standards or parts thereof. Article 114 \u2018Must carry\u2019 obligations 1. Member States may impose reasonable \u2018must carry\u2019 obligations for the transmission of specified radio and television broadcast channels and related complementary services, in particular accessibility services to enable appropriate access for end-users with disabilities and data supporting connected television services and EPGs, on undertakings under their jurisdiction providing electronic communications networks and services used for the distribution of radio or television broadcast channels to the public, where a significant number of end-users of such networks and services use them as their principal means to receive radio and television broadcast channels. Such obligations shall be imposed only where they are necessary to meet general interest objectives as clearly defined by each Member State and shall be proportionate and transparent. 2. By 21 December 2019 and every five years thereafter, Member States shall review the obligations referred to in the paragraph 1, except where Member States have carried out such a review within the previous four years. 3. Neither paragraph 1 of this Article nor Article 59(2) shall prejudice the ability of Member States to determine appropriate remuneration, if any, in respect of measures taken in accordance with this Article while ensuring that, in similar circumstances, there is no discrimination in the treatment of providers of electronic communications networks and services. Where remuneration is provided for, Member States shall ensure that the obligation to remunerate is clearly set out in national law, including, where relevant, the criteria for calculating such remuneration. Member States shall also ensure that it is applied in a proportionate and transparent manner. Article 115 Provision of additional facilities 1. Without prejudice to Article 88(2), Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities are able to require all providers of internet access services or publicly available number-based interpersonal communications services to make available free of charge all or part of the additional facilities listed in Part B of Annex VI, subject to technical feasibility, as well as all or part of the additional facilities listed in Part A of Annex VI. 2. When applying paragraph 1, Member States may go beyond the list of additional facilities in Parts A and B of Annex VI in order to ensure a higher level of consumer protection. 3. A Member State may decide to waive the application of paragraph 1 in all or part of its territory if it considers, after taking into account the views of interested parties, that there is sufficient access to those facilities. Article 116 Adaptation of annexes The Commission is empowered to adopt delegated acts in accordance with Article 117 amending Annexes V, VI, IX, X, and XI in order to take account of technological and social developments or changes in market demand. PART IV FINAL PROVISIONS Article 117 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 75, 109 and 116 shall be conferred on the Commission for a period of five years from 20 December 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 75, 109 and 116 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 75, 109 and 116 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 118 Committee 1. The Commission shall be assisted by a committee (\u2018the Communications Committee\u2019). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. For the implementing acts referred to in the second subparagraph of Article 28(4), the Commission shall be assisted by the Radio Spectrum Committee established pursuant to Article 3(1) of Decision No 676/2002/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 3. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a committee member so requests. In such a case, the chair shall convene a committee meeting within a reasonable time. 4. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply, having regard to Article 8 thereof. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a committee member so requests. In such a case, the chair shall convene a committee meeting within a reasonable time. Article 119 Exchange of information 1. The Commission shall provide all relevant information to the Communications Committee on the outcome of regular consultations with the representatives of network operators, service providers, users, consumers, manufacturers and trade unions, as well as third countries and international organisations. 2. The Communications Committee shall, taking account of the Union\u2019s electronic communications policy, foster the exchange of information between the Member States and between the Member States and the Commission on the situation and the development of regulatory activities regarding electronic communications networks and services. Article 120 Publication of information 1. Member States shall ensure that up-to-date information regarding the implementation of this Directive is made publicly available in a manner that guarantees all interested parties easy access to that information. They shall publish a notice in their national official gazette describing how and where the information is published. The first such notice shall be published before 21 December 2020 and thereafter a notice shall be published where there is any change in the information contained therein. 2. Member States shall submit to the Commission a copy of all such notices at the time of publication. The Commission shall distribute the information to the Communications Committee as appropriate. 3. Member States shall ensure that all relevant information on rights, conditions, procedures, charges, fees and decisions concerning general authorisations, rights of use and rights to install facilities is published and kept up to date in an appropriate manner in order to provide easy access to that information for all interested parties. 4. Where information referred to in paragraph 3 is held at different levels of government, in particular information regarding procedures and conditions on rights to install facilities, the competent authority shall make all reasonable efforts, having regard to the costs involved, to create a user-friendly overview of all such information, including information on the relevant levels of government and the responsible authorities, in order to facilitate applications for rights to install facilities. 5. Member States shall ensure that the specific obligations imposed on undertakings under this Directive are published and that the specific product and service, and geographical markets are identified. Subject to the need to protect commercial confidentiality, they shall ensure that up-to-date information is made publicly available in a manner that guarantees all interested parties easy access to that information. 6. Member States shall provide the Commission with information that they make publicly available pursuant to paragraph 5. The Commission shall make that information available in a readily accessible form, and shall distribute the information to the Communications Committee as appropriate. Article 121 Notification and monitoring 1. National regulatory authorities shall notify to the Commission by 21 December 2020, and immediately following any change thereafter, the names of undertakings designated as having universal service obligations under Article 85(2), Article 86 or 87. 2. National regulatory authorities shall notify to the Commission the names of undertakings designated as having significant market power for the purposes of this Directive, and the obligations imposed upon them under this Directive. Any changes affecting the obligations imposed upon undertakings or of the undertakings affected under this Directive shall be notified to the Commission without delay. Article 122 Review procedures 1. By 21 December 2025 and every five years thereafter, the Commission shall review the functioning of this Directive and report to the European Parliament and to the Council. Those reviews shall evaluate in particular the market implications of Article 61(3) and Articles 76, 78 and 79 and whether the ex ante and other intervention powers pursuant to this Directive are sufficient to enable national regulatory authorities to address uncompetitive oligopolistic market structures, and to ensure that competition in electronic communications markets continues to thrive to the benefit of end-users. To that end, the Commission may request information from the Member States, which shall be supplied without undue delay. 2. By 21 December 2025, and every five years thereafter, the Commission shall review the scope of universal service, in particular with a view to proposing to the European Parliament and to the Council that the scope be changed or redefined. That review shall be undertaken in light of social, economic and technological developments, taking into account, inter alia, mobility and data rates in light of the prevailing technologies used by the majority of end-users. The Commission shall submit a report to the European Parliament and to the Council regarding the outcome of the review. 3. BEREC shall, by 21 December 2021 and every three years thereafter, publish an opinion on the national implementation and functioning of the general authorisation, and on their impact on the functioning of the internal market. The Commission may, taking utmost account of the BEREC opinion, publish a report on the application of Chapter II of Title II of Part I and of Annex I, and may submit a legislative proposal to amend those provisions where it considers this to be necessary for the purpose of addressing obstacles to the proper functioning of the internal market. Article 123 Specific review procedure on end-user rights 1. BEREC shall monitor the market and technological developments regarding the different types of electronic communications services and shall, by 21 December 2021 and every three years thereafter, or upon a reasoned request from at least two of its Member State members, publish an opinion on such developments and on their impact on the application of Title III of Part III. In that opinion, BEREC shall assess to what extent Title III of Part III meets the objectives set out in Article 3. The opinion shall in particular take into account the scope of Title III of Part III as regards the types of electronic communications services covered. As a basis for the opinion, BEREC shall in particular analyse: (a) to what extent end-users of all electronic communications services are able to make free and informed choices, including on the basis of complete contractual information, and are able to switch easily their provider of electronic communications services; (b) to what extent any lack of abilities referred to in point (a) has resulted in market distortions or end-user harm; (c) to what extent effective access to emergency services is appreciably threatened, in particular due to an increased use of number-independent interpersonal communications services, by a lack of interoperability or technological developments; (d) the likely cost of any potential readjustments of obligations in Title III of Part III or impact on innovation for providers of electronic communications services. 2. The Commission, taking utmost account of the BEREC opinion, shall publish a report on the application of Title III of Part III and shall submit a legislative proposal to amend that Title where it considers this to be necessary to ensure that the objectives set out in Article 3 continue to be met. Article 124 Transposition 1. Member States shall adopt and publish, by 21 December 2020, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those measures to the Commission. Member States shall apply those measures from 21 December 2020. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directives repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. By way of derogation from paragraph 1 of this Article, Article 53(2), (3) and (4) of this Directive shall apply from 20 December 2018 where harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable the radio spectrum use for wireless broadband networks and services. In relation to radio spectrum bands for which harmonised conditions have not been set by 20 December 2018, Article 53(2), (3) and (4) of this Directive shall apply from the date of the adoption of the technical implementing measures in accordance with Article 4 of Decision No 676/2002/EC. By way of derogation from paragraph 1 of this Article, Member States shall apply the measures necessary to comply with Article 54 from 31 December 2020. 3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 125 Repeal Directives 2002/19/EC, 2002/20/EC, 2002/21/EC, 2002/22/EC, as listed in Annex XII, Part A, are repealed with effect from 21 December 2020, without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law and the dates of application of the Directives set out in Annex XII, Part B. Article 5 of Decision No 243/2012/EU is deleted with effect from 21 December 2020. References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex XIII. Article 126 Entry into force This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 127 Addressees This Directive is addressed to the Member States. Done at Strasbourg, 11 December 2018. For the European Parliament The President A. TAJANI For the Council The President J. BOGNER-STRAUSS (1) OJ C 125, 21.4.2017, p. 56. (2) OJ C 207, 30.6.2017, p. 87. (3) Position of the European Parliament of 14 November 2018 (not yet published in the Official Journal) and decision of the Council of 4 December 2018. (4) Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive) (OJ L 108, 24.4.2002, p. 7). (5) Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive) (OJ L 108, 24.4.2002, p. 21). (6) Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, p. 33) (7) Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users\u2019 rights relating to electronic communications networks and services (Universal Service Directive) (OJ L 108, 24.4.2002, p. 51). (8) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (9) Regulation (EC) No 1211/2009 of the European Parliament and of the Council of 25 November 2009 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Office (OJ L 337, 18.12.2009, p. 1). (10) OJ C 77, 28.3.2002, p. 1. (11) Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, p. 1). (12) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). (13) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (14) Regulation (EU) 2015/2120 of the European Parliament and of the Council of 25 November 2015 laying down measures concerning open internet access and amending Directive 2002/22/EC on universal service and users\u2019 rights relating to electronic communications networks and services and Regulation (EU) No 531/2012 on roaming on public mobile communications networks within the Union (OJ L 310, 26.11.2015, p. 1). (15) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (16) Judgment of the Court of Justice of 26 April 1988, Bond van Adverteerders and Others v The Netherlands State, C-352/85, ECLI: EU:C:1988:196. (17) Regulation (EU) 2015/758 of the European Parliament and of the Council of 29 April 2015 concerning type-approval requirements for the deployment of the eCall in-vehicle system based on the 112 service and amending Directive 2007/46/EC (OJ L 123, 19.5.2015, p 77). (18) Commission Regulation (EU) No 305/2013 of 26 November 2012 supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to the harmonised provision for an interoperable EU-wide eCall (OJ L 91, 3.4.2013, p. 1). (19) Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, p. 7). (20) Regulation (EU) No 531/2012 of the European Parliament and of the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (OJ L 172, 30.6.2012, p. 10). (21) in particular the judgment of the Court of Justice of 16 October 2012, European Commission v Republic of Austria, Case C-614/10, ECLI:EU:C:2012:631. (22) Directive 2014/61/EU of the European Parliament and of the Council of 15 May 2014 on measures to reduce the cost of deploying high-speed electronic communications networks (OJ L 155, 23.5.2014, p. 1). (23) Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (OJ L 177, 4.7.2008, p. 6). (24) Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a regulatory framework for radio spectrum policy in the European Community (Radio Spectrum Decision) (OJ L 108, 24.4.2002, p. 1). (25) Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (OJ L 345, 31.12.2003, p. 90). (26) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (27) Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Directive on consumer ADR) (OJ L 165, 18.6.2013, p. 63). (28) Commission Decision 2002/622/EC of 26 July 2002 establishing a Radio Spectrum Policy Group (OJ L 198, 27.7.2002, p. 49). (29) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). (30) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357). (31) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). (32) Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) (OJ L 199, 30.7.1999, p. 59). (33) Decision (EU) 2017/899 of the European Parliament and of the Council of 17 May 2017 on the use of the 470-790 MHz frequency band in the Union (OJ L 138, 25.5.2017, p. 131). (34) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). (35) Commission Recommendation 2005/698/EC of 19 September 2005 on accounting separation and cost accounting systems under the regulatory framework for electronic communications (OJ L 266, 11.10.2005, p. 64). (36) Commission Recommendation 2013/466/EU of 11 September 2013 on consistent non-discrimination obligations and costing methodologies to promote competition and enhance the broadband investment environment (OJ L 251, 21.9.2013, p. 13). (37) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29). (38) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (39) Commission Directive 2002/77/EC of 16 September 2002 on competition in the markets for electronic communications networks and services (OJ L 249, 17.9.2002, p. 21). (40) OJ L 123, 12.5.2016, p. 1. (41) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (42) OJ C 369, 17.12.2011, p. 14. (43) Commission Directive 2008/63/EC of 20 June 2008 on competition in the markets in telecommunications terminal equipment (OJ L 162, 21.6.2008, p. 20). (44) Regulation (EU) 2018/1971 of the European Parliament and of the Council of 11 December 2018 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Agency for Support for BEREC (BEREC Office), amending Regulation (EU) 2015/2120 and repealing Regulation (EC) No 1211/2009 (see page 1 of this Official Journal). (45) Regulation (EU) No 526/2013 of the European Parliament and of the Council of 21 May 2013 concerning the European Union Agency for Network and Information Security (ENISA) and repealing Regulation (EC) No 460/2004 (OJ L 165, 18.6.2013, p. 41). (46) Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348 20.12.2013, p. 1). (47) Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38). ANNEX I LIST OF CONDITIONS WHICH MAY BE ATTACHED TO GENERAL AUTHORISATIONS, RIGHTS OF USE FOR RADIO SPECTRUM AND RIGHTS OF USE FOR NUMBERING RESOURCES This Annex provides for the maximum list of conditions which may be attached to general authorisations for electronic communications networks and services, except number-independent interpersonal communications services (Part A), electronic communications networks (Part B), electronic communications services, except number-independent interpersonal communications services (Part C), rights of use for radio spectrum (Part D), and rights of use for numbering resources (Part E) A. General conditions which may be attached to a general authorisation 1. Administrative charges in accordance with Article 16. 2. Personal data and privacy protection specific to the electronic communications sector in accordance with Directive 2002/58/EC 3. Information to be provided under a notification procedure in accordance with Article 12 and for other purposes as included in Article 21. 4. Enabling of legal interception by competent national authorities in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC. 5. Terms of use for communications from public authorities to the general public for warning the public of imminent threats and for mitigating the consequences of major catastrophes. 6. Terms of use during major disasters or national emergencies to ensure communications between emergency services and authorities. 7. Access obligations other than those provided for in Article 13 applying to undertakings providing electronic communications networks or services. 8. Measures designed to ensure compliance with the standards or specifications referred to in Article 39. 9. Transparency obligations on providers of public electronic communications network providing publicly available electronic communications services to ensure end-to-end connectivity, in accordance with the objectives and principles set out in Article 3 and, where necessary and proportionate, access by competent authorities to such information needed to verify the accuracy of such disclosure. B. Specific conditions which may be attached to a general authorisation for the provision of electronic communications networks 1. Interconnection of networks in accordance with this Directive. 2. \u2018Must carry\u2019 obligations in accordance with this Directive. 3. Measures for the protection of public health against electromagnetic fields caused by electronic communications networks in accordance with Union law, taking utmost account of Recommendation 1999/519/EC. 4. Maintenance of the integrity of public electronic communications networks in accordance with this Directive including by conditions to prevent electromagnetic interference between electronic communications networks or services in accordance with Directive 2014/30/EU. 5. Security of public networks against unauthorised access in accordance with Directive 2002/58/EC. 6. Conditions for the use of radio spectrum, in accordance with Article 7(2) of Directive 2014/53/EU, where such use is not made subject to the granting of individual rights of use in accordance with Article 46(1) and Article 48 of this Directive. C. Specific conditions which may be attached to a general authorisation for the provision of electronic communications services, except number-independent interpersonal communications services 1. Interoperability of services in accordance with this Directive. 2. Accessibility by end-users of numbers from the national numbering plan, numbers from the UIFN and, where technically and economically feasible, from numbering plans of other Member States, and conditions in accordance with this Directive. 3. Consumer protection rules specific to the electronic communications sector. 4. Restrictions in relation to the transmission of illegal content in accordance with Directive 2000/31/EC and restrictions in relation to the transmission of harmful content in accordance with Directive 2010/13/EU. D. Conditions which may be attached to rights of use for radio spectrum 1. Obligation to provide a service or to use a type of technology within the limits of Article 45 including, where appropriate, coverage and quality of service requirements. 2. Effective and efficient use of radio spectrum in accordance with this Directive. 3. Technical and operational conditions necessary for the avoidance of harmful interference and for the protection of public health against electromagnetic fields, taking utmost account of Recommendation 1999/519/EC where such conditions are different from those included in the general authorisation. 4. Maximum duration in accordance with Article 49, subject to any changes in the National Frequency Allocation Plan. 5. Transfer or leasing of rights at the initiative of the holder of the rights and conditions for such transfer in accordance with this Directive. 6. Fees for rights of use in accordance with Article 42. 7. Any commitments which the undertaking obtaining the rights of use has made in the framework of an authorisation or authorisation renewal process prior to the authorisation being granted or, where applicable, to the invitation for application for rights of use. 8. Obligations to pool or share radio spectrum or allow access to radio spectrum for other users in specific regions or at national level. 9. Obligations under relevant international agreements relating to the use of radio spectrum bands. 10. Obligations specific to an experimental use of radio spectrum bands. E. Conditions which may be attached to rights of use for numbering resources 1. Designation of service for which the number shall be used, including any requirements linked to the provision of that service and, for the avoidance of doubt, tariff principles and maximum prices that can apply in the specific number range for the purposes of ensuring consumer protection in accordance with point (d) of Article 3(2). 2. Effective and efficient use of numbering resources in accordance with this Directive. 3. Number portability requirements in accordance with this Directive. 4. Obligation to provide public directory end-user information for the purposes of Article 112. 5. Maximum duration in accordance with Article 94, subject to any changes in the national numbering plan. 6. Transfer of rights at the initiative of the holder of the rights and conditions for such transfer in accordance with this Directive, including any condition that the right of use for a number be binding on all the undertakings to which the rights are transferred. 7. Fees for rights of use in accordance with Article 95. 8. Any commitments which the undertaking obtaining the rights of use has made in the course of a competitive or comparative selection procedure. 9. Obligations under relevant international agreements relating to the use of numbers. 10. Obligations concerning the extraterritorial use of numbers within the Union to ensure compliance with consumer protection and other number-related rules in Member States other than that of the country code. ANNEX II CONDITIONS FOR ACCESS TO DIGITAL TELEVISION AND RADIO SERVICES BROADCAST TO VIEWERS AND LISTENERS IN THE UNION Part I Conditions for conditional access systems to be applied in accordance with Article 62(1) In relation to conditional access to digital television and radio services broadcast to viewers and listeners in the Union, irrespective of the means of transmission, Member States shall ensure in accordance with Article 62 that the following conditions apply: (a) all undertakings providing conditional access services, irrespective of the means of transmission, which provide access services to digital television and radio services and the access services of which broadcasters depend on to reach any group of potential viewers or listeners are to: \u2014 offer to all broadcasters, on a fair, reasonable and non-discriminatory basis compatible with Union competition law, technical services enabling the broadcasters\u2019 digitally-transmitted services to be received by viewers or listeners authorised by means of decoders administered by the service operators, and comply with Union competition law, \u2014 keep separate financial accounts regarding their activity as conditional access providers. (b) when granting licences to manufacturers of consumer equipment, holders of industrial property rights to conditional access products and systems are to ensure that this is done on fair, reasonable and non-discriminatory terms. Taking into account technical and commercial factors, holders of rights are not to subject the granting of licences to conditions prohibiting, deterring or discouraging the inclusion in the same product of: \u2014 a common interface allowing connection with several other access systems, or \u2014 means specific to another access system, provided that the licensee complies with the relevant and reasonable conditions ensuring, as far as he is concerned, the security of transactions of conditional access system operators. Part II Other facilities to which conditions may be applied under point (D) of Article 61(2) (a) Access to APIs; (b) Access to EPGs. ANNEX III CRITERIA FOR THE DETERMINATION OF WHOLESALE VOICE TERMINATION RATES Principles, criteria and parameters for the determination of rates for wholesale voice termination on fixed and mobile markets referred to in Article 75(1): (a) rates shall be based on the recovery of costs incurred by an efficient operator; the evaluation of efficient costs shall be based on current cost values; the cost methodology to calculate efficient costs shall be based on a bottom-up modelling approach using long-run incremental traffic-related costs of providing the wholesale voice termination service to third parties; (b) the relevant incremental costs of the wholesale voice termination service shall be determined by the difference between the total long-run costs of an operator providing its full range of services and the total long-run costs of that operator not providing a wholesale voice termination service to third parties; (c) only those traffic-related costs which would be avoided in the absence of a wholesale voice termination service being provided shall be allocated to the relevant termination increment; (d) costs related to additional network capacity shall be included only to the extent that they are driven by the need to increase capacity for the purpose of carrying additional wholesale voice termination traffic; (e) radio spectrum fees shall be excluded from the mobile voice termination increment; (f) only those wholesale commercial costs shall be included which are directly related to the provision of the wholesale voice termination service to third parties; (g) all fixed network operators shall be considered to provide voice termination services at the same unit costs as the efficient operator, regardless of their size; (h) for mobile network operators, the minimum efficient scale shall be set at a market share not below 20 %; (i) the relevant approach for asset depreciation shall be economic depreciation; and (j) the technology choice of the modelled networks shall be forward looking, based on an IP core network, taking into account the various technologies likely to be used over the period of validity of the maximum rate; in the case of fixed networks, calls shall be considered to be exclusively packet switched. ANNEX IV CRITERIA FOR ASSESSING CO-INVESTMENT OFFERS When assessing a co-investment offer pursuant to Article 76(1), the national regulatory authority shall verify whether the following criteria have at a minimum been met. National regulatory authorities may consider additional criteria to the extent they are necessary to ensure accessibility of potential investors to the co-investment, in light of specific local conditions and market structure: (a) The co-investment offer shall be open to any undertaking over the lifetime of the network built under a co-investment offer on a non-discriminatory basis. The undertaking designated as having significant market power may include in the offer reasonable conditions regarding the financial capacity of any undertaking, so that for instance potential co-investors need to demonstrate their ability to deliver phased payments on the basis of which the deployment is planned, the acceptance of a strategic plan on the basis of which medium-term deployment plans are prepared, and so on. (b) The co-investment offer shall be transparent: \u2014 the offer shall be available and easily identified on the website of the undertaking designated as having significant market power; \u2014 full detailed terms shall be made available without undue delay to any potential bidder that has expressed an interest, including the legal form of the co-investment agreement and, when relevant, the heads of term of the governance rules of the co-investment vehicle; and \u2014 the process, like the road map for the establishment and development of the co-investment project shall be set in advance, shall be clearly explained in writing to any potential co-investor, and all significant milestones shall be clearly communicated to all undertakings without any discrimination. (c) The co-investment offer shall include terms to potential co-investors which favour sustainable competition in the long term, in particular: \u2014 All undertakings shall be offered fair, reasonable and non-discriminatory terms and conditions for participation in the co-investment agreement relative to the time they join, including in terms of financial consideration required for the acquisition of specific rights, in terms of the protection awarded to the co-investors by those rights both during the building phase and during the exploitation phase, for example by granting indefeasible rights of use (IRUs) for the expected lifetime of the co-invested network and in terms of the conditions for joining and potentially terminating the co-investment agreement. Non-discriminatory terms in this context do not entail that all potential co-investors shall be offered exactly the same terms, including financial terms, but that all variations of the terms offered shall be justified on the basis of the same objective, transparent, non-discriminatory and predictable criteria such as the number of end-user lines committed for. \u2014 The offer shall allow flexibility in terms of the value and timing of the commitment provided by each co-investor, for example by means of an agreed and potentially increasing percentage of the total end-user lines in a given area, to which co-investors have the possibility to commit gradually and which is set at a unit level enabling smaller co-investors with limited resources to enter the co-investment at a reasonably minimum scale and to gradually increase their participation while ensuring adequate levels of initial commitment. The determination of the financial consideration to be provided by each co-investor needs to reflect the fact that early investors accept greater risks and engage capital sooner. \u2014 A premium increasing over time shall be considered to be justified for commitments made at later stages and for new co-investors entering the co-investment after the commencement of the project, to reflect diminishing risks and to counteract any incentive to withhold capital in the earlier stages. \u2014 The co-investment agreement shall allow the assignment of acquired rights by co-investors to other co-investors, or to third parties willing to enter into the co-investment agreement subject to the transferee undertaking being obliged to fulfil all original obligations of the transferor under the co-investment agreement. \u2014 Co-investors shall grant each other reciprocal rights on fair and reasonable terms and conditions to access the co-invested infrastructure for the purposes of providing services downstream, including to end-users, in accordance with transparent conditions which are to be made transparent in the co-investment offer and subsequent agreement, in particular where co-investors are individually and separately responsible for the deployment of specific parts of the network. If a co-investment vehicle is created, it shall provide access to the network to all co-investors, whether directly or indirectly, on an equivalence of inputs basis and in accordance with fair and reasonable terms and conditions, including financial conditions that reflect the different levels of risk accepted by the individual co-investors. (d) The co-investment offer shall ensure a sustainable investment likely to meet future needs, by deploying new network elements that contribute significantly to the deployment of very high capacity networks. ANNEX V MINIMUM SET OF SERVICES WHICH THE ADEQUATE BROADBAND INTERNET ACCESS SERVICE IN ACCORDANCE WITH ARTICLE 84(3) SHALL BE CAPABLE OF SUPPORTING (1) E-mail (2) search engines enabling search and finding of all type of information (3) basic training and education online tools (4) online newspapers or news (5) buying or ordering goods or services online (6) job searching and job searching tools (7) professional networking (8) internet banking (9) eGovernment service use (10) social media and instant messaging (11) calls and video calls (standard quality) ANNEX VI DESCRIPTION OF FACILITIES AND SERVICES REFERRED TO IN ARTICLE 88 (CONTROL OF EXPENDITURE), ARTICLE 115 (ADDITIONAL FACILITIES) AND ARTICLE 106 (PROVIDER SWITCHING AND NUMBER PORTABILITY) Part A Facilities and services referred to in Articles 88 and 115 When applied on the basis of Article 88, Part A is applicable to consumers and other categories of end-users where Member States have extended the beneficiaries of Article 88(2). When applied on the basis of Article 115, Part A is applicable to the categories of end-users determined by Member States, except for points (c), (d) and (g) of this Part which are applicable only to consumers. (a) Itemised billing Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities, subject to the requirements of relevant law on the protection of personal data and privacy, may lay down the basic level of itemised bills which are to be offered by providers to end-users free of charge in order that they can: (i) allow verification and control of the charges incurred in using internet access services or voice communications services, or number-based interpersonal communications services in the case of Article 115; and (ii) adequately monitor their usage and expenditure and thereby exercise a reasonable degree of control over their bills. Where appropriate, additional levels of detail may be offered to end-users at reasonable tariffs or at no charge. Such itemised bills shall include an explicit mention of the identity of the supplier and of the duration of the services charged by any premium numbers unless the end-user has requested that information not to be mentioned. Calls which are free of charge to the calling end-users, including calls to helplines, shall not be required to be identified in the calling end-user\u2019s itemised bill. National regulatory authorities may require operators to provide calling-line identification free of charge. (b) Selective barring for outgoing calls or premium SMS or MMS, or, where technically feasible, other kinds of similar applications, free of charge namely, the facility whereby the end-users can, on request to the providers of voice communications services, or number-based interpersonal communications services in the case of Article 115, bar outgoing calls or premium SMS or MMS or other kinds of similar applications of defined types or to defined types of numbers free of charge. (c) Pre-payment systems Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities may require providers to offer means for consumers to pay for access to the public electronic communications network and use of voice communications services, or internet access services, or number-based interpersonal communications services in the case of Article 115, on pre-paid terms. (d) Phased payment of connection fees Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities may require providers to allow consumers to pay for connection to the public electronic communications network on the basis of payments phased over time. (e) Non-payment of bills Member States shall authorise specified measures, which are to be proportionate, non-discriminatory and published, to cover non-payment of bills issued by providers. Those measures are to ensure that due warning of any consequent service interruption or disconnection is given to the end-users beforehand. Except in cases of fraud, persistent late payment or non-payment, those measures shall ensure, as far as is technically feasible, that any service interruption is confined to the service concerned. Disconnection for non-payment of bills shall take place only after due warning is given to the end-users. Member States may allow a period of limited service prior to complete disconnection, during which only calls that do not incur a charge to the end-users (for example, calls to the \u2018112\u2019 number) and minimum service level of internet access services, defined by Member States in light of national conditions, are permitted. (f) Tariff advice namely, the facility whereby end-users may request the provider to offer information regarding alternative lower-cost tariffs, if available. (g) Cost control namely, the facility whereby providers offer other means, if determined to be appropriate by competent authorities in coordination, where relevant, with national regulatory authorities, to control the costs of voice communications services or internet access services, or number-based interpersonal communications services in the case of Article 115, including free-of-charge alerts to consumers in the case of abnormal or excessive consumption patterns. (h) facility to deactivate third party billing namely, the facility for end-users to deactivate the ability for third party service providers to use the bill of a provider of an internet access service or a provider of a publicly available interpersonal communications service to charge for their products or services. Part B Facilities referred to in Article 115 (a) Calling-line identification namely, the calling party\u2019s number is presented to the called party prior to the call being established. This facility shall be provided in accordance with relevant law on protection of personal data and privacy, in particular Directive 2002/58/EC. To the extent technically feasible, operators shall provide data and signals to facilitate the offering of calling-line identity and tone dialling across Member State boundaries. (b) E-mail forwarding or access to e-mails after termination of the contract with a provider of an internet access service. This facility shall, on request and free-of-charge, enable end-users who terminate their contract with a provider of an internet access service to either access their e-mails received on the e-mail address(es) based on the commercial name or trade mark of the former provider, during a period that the national regulatory authority considers necessary and proportionate, or to transfer e-mails sent to that (or those) address(es) during that period to a new email address specified by the end-user. Part C Implementation of the number portability provisions referred to in Article 106 The requirement that all end-users with numbers from the national numbering plan, who so request can retain their numbers independently of the undertaking providing the service shall apply: (a) in the case of geographic numbers, at a specific location; and (b) in the case of non-geographic numbers, at any location. This Part does not apply to the porting of numbers between networks providing services at a fixed location and mobile networks. ANNEX VII CALCULATING THE NET COST, IF ANY, OF UNIVERSAL SERVICE OBLIGATIONS AND ESTABLISHING ANY COMPENSATION OR SHARING MECHANISM IN ACCORDANCE WITH ARTICLES 89 AND 90 Part A Calculation of net cost Universal service obligations refer to those obligations placed upon an undertaking by a Member State which concern the provision of universal service as set out in Articles 84 to 87. National regulatory authorities are to consider all means to ensure appropriate incentives for undertakings (designated or not) to provide universal service obligations cost efficiently. In undertaking a calculation exercise, the net cost of universal service obligations is to be calculated as the difference between the net cost for any undertaking operating with the universal service obligations and operating without the universal service obligations. Due attention is to be given to correctly assessing the costs that any undertaking would have chosen to avoid had there been no universal service obligations. The net cost calculation shall assess the benefits, including intangible benefits, to the universal service provider. The calculation is to be based upon the costs attributable to: (i) elements of the identified services which can only be provided at a loss or provided under cost conditions falling outside normal commercial standards. This category may include service elements such as access to emergency telephone services, provision of certain public pay telephones, provision of certain services or equipment for end-users with disabilities, and so on; (ii) specific end-users or groups of end-users who, taking into account the cost of providing the specified network and service, the revenue generated and any geographical averaging of prices imposed by the Member State, can only be served at a loss or under cost conditions falling outside normal commercial standards. This category includes those end-users or groups of end-users which would not be served by a commercial provider which did not have an obligation to provide universal service. The calculation of the net cost of specific aspects of universal service obligations is to be made separately and in order to avoid the double counting of any direct or indirect benefits and costs. The overall net cost of universal service obligations to any undertaking is to be calculated as the sum of the net costs arising from the specific components of universal service obligations, taking account of any intangible benefits. The responsibility for verifying the net cost lies with the national regulatory authority. Part B Compensation of net costs of universal service obligations The recovery or financing of any net costs of universal service obligations may require undertakings with universal service obligations to be compensated for the services they provide under non-commercial conditions. Because such a compensation involves financial transfers, Member States are to ensure that those are undertaken in an objective, transparent, non-discriminatory and proportionate manner. This means that the transfers result in the least distortion to competition and to user demand. In accordance with Article 90(3), a sharing mechanism based on a fund shall use a transparent and neutral means for collecting contributions that avoids the danger of a double imposition of contributions falling on both outputs and inputs of undertakings. The independent body administering the fund is to be responsible for collecting contributions from undertakings which are assessed as liable to contribute to the net cost of universal service obligations in the Member State and is to oversee the transfer of sums due or administrative payments to the undertakings entitled to receive payments from the fund. ANNEX VIII INFORMATION REQUIREMENTS TO BE PROVIDED IN ACCORDANCE WITH ARTICLE 102 (INFORMATION REQUIREMENTS FOR CONTRACTS) A. Information requirements for providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services Providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services shall provide the following information: (1) as part of the main characteristics of each service provided, any minimum levels of quality of service to the extent that those are offered and, for services other than internet access services, the specific quality parameters assured. Where no minimum levels of quality of service are offered, a statement to this effect shall be made; (2) as part of the information on price, where and to the extent applicable, the respective prices for activating the electronic communications service and for any recurring or consumption-related charges; (3) as part of the information on the duration of the contract and the conditions for renewal and termination of the contract, including possible termination fees, to the extent that such conditions apply: (i) any minimum use or duration required to benefit from promotional terms; (ii) any charges related to switching and compensation and refund arrangements for delay or abuse of switching, as well as information about the respective procedures; (iii) information on the right of consumers using pre-paid services to a refund, upon request, of any remaining credit in the event of switching, as set out in Article 106(6); (iv) any fees due on early termination of the contract, including information on unlocking the terminal equipment and any cost recovery with respect to terminal equipment; (4) any compensation and refund arrangements, including, where applicable, explicit reference to rights of consumers, which apply if contracted levels of quality of service are not met or if the provider responds inadequately to a security incident, threat or vulnerability; (5) the type of action that might be taken by the provider in reaction to security incidents or threats or vulnerabilities. B. Information requirements for providers of internet access services and publicly available interpersonal communications services I. In addition to the requirements set out in Part A, providers of internet access services and publicly available interpersonal communications services shall provide the following information: (1) as part of the main characteristics of each service provided: (i) any minimum levels of quality of service to the extent that these are offered, and taking utmost account of the BEREC guidelines adopted in accordance with Article 104(2) regarding: \u2014 for internet access services: at least latency, jitter, packet loss, \u2014 for publicly available interpersonal communications services, where they exert control over at least some elements of the network or have a service level agreement to that effect with undertakings providing access to the network: at least the time for the initial connection, failure probability, call signalling delays in accordance with Annex X; and (ii) without prejudice to the right of end-users to use terminal equipment of their choice in accordance with Article 3(1) of Regulation (EU) 2015/2120, any conditions, including fees, imposed by the provider on the use of terminal equipment supplied; (2) as part of the information on price, where and to the extent applicable, the respective prices for activating the electronic communications service and for any recurring or consumption-related charges: (i) details of specific tariff plan or plans under the contract and, for each such tariff plan the types of services offered, including where applicable, the volumes of communications (such as MB, minutes, messages) included per billing period, and the price for additional communication units; (ii) in the case of tariff plan or plans with a pre-set volume of communications, the possibility for consumers to defer any unused volume from the preceding billing period to the following billing period, where this option is included in the contract; (iii) facilities to safeguard bill transparency and monitor the level of consumption; (iv) tariff information regarding any numbers or services subject to particular pricing conditions; with respect to individual categories of services, competent authorities in coordination, where relevant, with national regulatory authorities may require in addition such information to be provided immediately prior to connecting the call or to connecting to the provider of the service; (v) for bundled services and bundles including both services and terminal equipment the price of the individual elements of the bundle to the extent they are also marketed separately; (vi) details and conditions, including fees, of any after-sales service, maintenance, and customer assistance; and (vii) the means by which up-to-date information on all applicable tariffs and maintenance charges may be obtained; (3) as part of the information on the duration of the contract for bundled services and the conditions for renewal and termination of the contract, where applicable, the conditions of termination of the bundle or of elements thereof; (4) without prejudice to Article 13 of the Regulation (EU) 2016/679, information on what personal data shall be provided before the performance of the service or collected in the context of the provision of the service; (5) details on products and services designed for end-users with disabilities and how updates on this information can be obtained; (6) the means of initiating procedures for the resolution of disputes including national and cross-border disputes in accordance with Article 25. II. In addition to the requirements set out in Part A and under Point I, providers of publicly available number-based interpersonal communications services shall also provide the following information: (1) any constraints on access to emergency services or caller location information due to a lack of technical feasibility insofar as the service allows end-users to originate calls to a number in a national or international numbering plan; (2) the end-user\u2019s right to determine whether to include his or her personal data in a directory, and the types of data concerned, in accordance with Article 12 of Directive 2002/58/EC; III. In addition to the requirements set out in Part A and under Point I, providers of internet access services shall also provide the information required pursuant to Article 4(1) of Regulation (EU) 2015/2120. ANNEX IX INFORMATION TO BE PUBLISHED IN ACCORDANCE WITH ARTICLE 103 (TRANSPARENCY AND PUBLICATION OF INFORMATION) The competent authority in coordination, where relevant, with the national regulatory authority is responsible for ensuring that the information in this Annex is published, in accordance with Article 103. The competent authority in coordination, where relevant, with the national regulatory authority shall decide which information is relevant to be published by the providers of internet access services or publicly available interpersonal communications services, and which information is to be published by the competent authority itself in coordination, where relevant, with the national regulatory authority, in order to ensure that all end-users are able to make informed choices. If considered to be appropriate, competent authorities in coordination, where relevant, with national regulatory authorities may promote self- or co-regulatory measures prior to imposing any obligation. 1. Contact details of the undertaking 2. Description of the services offered 2.1. Scope of the services offered and the main characteristics of each service provided, including any minimum levels of quality of service where offered and any restrictions imposed by the provider on the use of terminal equipment supplied. 2.2. Tariffs of the services offered, including information on communications volumes (such as restrictions of data usage, numbers of voice minutes, numbers of messages) of specific tariff plans and the applicable tariffs for additional communication units, numbers or services subject to particular pricing conditions, charges for access and maintenance, all types of usage charges, special and targeted tariff schemes and any additional charges, as well as costs with respect to terminal equipment. 2.3. After-sales, maintenance and customer assistance services offered and their contact details. 2.4. Standard contract conditions, including contract duration, charges due on early termination of the contract, rights related to the termination of bundled offers or of elements thereof, and procedures and direct charges related to the portability of numbers and other identifiers, if relevant. 2.5. If the undertaking is a provider of number-based interpersonal communications services, information on access to emergency services and caller location, or any limitation on the latter. If the undertaking is a provider of number-independent interpersonal communications services, information on the degree to which access to emergency services may be supported or not. 2.6. Details of products and services, including any functions, practices, policies and procedures and alterations in the operation of the service, specifically designed for end-users with disabilities, in accordance with Union law harmonising accessibility requirements for products and services. 3. Dispute resolution mechanisms, including those developed by the undertaking. ANNEX X QUALITY OF SERVICE PARAMETERS Quality-of-Service Parameters, Definitions and Measurement Methods referred to in Article 104 For providers of access to a public electronic communications network PARAMETER (Note 1) DEFINITION MEASUREMENT METHOD Supply time for initial connection ETSI EG 202 057 ETSI EG 202 057 Fault rate per access line ETSI EG 202 057 ETSI EG 202 057 Fault repair time ETSI EG 202 057 ETSI EG 202 057 For providers of interpersonal communications services who exert control over at least some elements of the network or have a service level agreement to that effect with undertakings providing access to the network PARAMETER (Note 2) DEFINITION MEASUREMENT METHOD Call set up time ETSI EG 202 057 ETSI EG 202 057 Bill correctness complaints ETSI EG 202 057 ETSI EG 202 057 Voice connection quality ETSI EG 202 057 ETSI EG 202 057 Dropped call ratio ETSI EG 202 057 ETSI EG 202 057 Unsuccessful call ratio (Note 2) ETSI EG 202 057 ETSI EG 202 057 Failure probability Call signalling delays Version number of ETSI EG 202 057-1 is 1.3.1 (July 2008) For providers of internet access services PARAMETER DEFINITION MEASUREMENT METHOD Latency (delay) ITU-T Y.2617 ITU-T Y.2617 Jitter ITU-T Y.2617 ITU-T Y.2617 Packet loss ITU-T Y.2617 ITU-T Y.2617 Note 1 Parameters shall allow for performance to be analysed at a regional level (namely, no less than level 2 in the Nomenclature of Territorial Units for Statistics (NUTS) established by Eurostat). Note 2 Member States may decide not to require up-to-date information concerning the performance for those two parameters to be kept if evidence is available to show that performance in those two areas is satisfactory. ANNEX XI INTEROPERABILITY OF CAR RADIO RECEIVERS AND CONSUMER DIGITAL TELEVISION EQUIPMENT REFERRED TO IN ARTICLE 113 1. Common scrambling algorithm and free-to-air reception All consumer equipment intended for the reception of digital television signals (namely, broadcasting via terrestrial, cable or satellite transmission), for sale or rent or otherwise made available in the Union, capable of descrambling digital television signals, is to possess the capability to: (a) allow the descrambling of such signals in accordance with a common European scrambling algorithm as administered by a recognised European standardisation organisation (currently ETSI); (b) display signals that have been transmitted in the clear, provided that, in the event that such equipment is rented, the renter complies with the relevant rental agreement. 2. Interoperability for digital television sets Any digital television set with an integral screen of visible diagonal larger than 30 cm which is put on the market for sale or rent in the Union is to be fitted with at least one open interface socket (either standardised by, or conforming to a standard adopted by, a recognised European standardisation organisation, or conforming to an industry-wide specification) permitting simple connection of peripherals, and able to pass all relevant elements of a digital television signal, including information relating to interactive and conditionally accessed services. 3. Interoperability for car radio receivers Any car radio receiver integrated in a new vehicle of category M which is made available on the market for sale or rent in the Union from 21 December 2020 shall comprise a receiver capable of receiving and reproducing at least radio services provided via digital terrestrial radio broadcasting. Receivers which are in accordance with harmonised standards the references of which have been published in the Official Journal of the European Union or with parts thereof shall be considered to comply with that requirement covered by those standards or parts thereof. ANNEX XII Part A Repealed Directives with list of the successive amendments thereto (referred to in Article 125) Directive 2002/21/EC of the European Parliament and of the Council (OJ L 108, 24.4.2002, p. 33) Directive 2009/140/EC of the European Parliament and of the Council (OJ L 337, 18.12.2009, p. 37) Article 1 Regulation (EC) No 544/2009 of the European Parliament and of the Council (OJ L 167, 29.6.2009, p. 12) Article 2 Regulation (EC) No 717/2007 of the European Parliament and of the Council (OJ L 171, 29.6.2007, p. 32) Article 10 Directive 2002/20/EC of the European Parliament and of the Council (OJ L 108, 24.4.2002, p. 21) Directive 2009/140/EC of the European Parliament and of the Council (OJ L 337, 18.12.2009, p. 37) Article 3 and Annex Directive 2002/19/EC of the European Parliament and of the Council (OJ L 108, 24.4.2002, p. 7) Directive 2009/140/EC of the European Parliament and of the Council (OJ L 337, 18.12.2009, p. 37) Article 2 Directive 2002/22/EC of the European Parliament and of the Council (OJ L 108, 24.4.2002, p. 51) Directive 2009/136/EC of the European Parliament and of the Council (OJ L 337, 18.12.2009, p. 11) Article 1 and Annex I Regulation (EU) 2015/2120 of the European Parliament and of the Council (OJ L 310, 26.11.2015, p. 1) Article 8 Part B Time-limits for transposition into national law and dates of application (referred to in Article 125) Directive Time-limit for transposition Date of application 2002/19/EC 24 July 2003 25 July 2003 2002/20/EC 24 July 2003 25 July 2003 2002/21/EC 24 July 2003 25 July 2003 2002/22/EC 24 July 2003 25 July 2003 ANNEX XIII CORRELATION TABLE Directive 2002/21/EC Directive 2002/20/EC Directive 2002/19/EC Directive 2002/22/EC This Directive Article 1(1), (2) and (3) Article 1(1), (2) and (3) Article 1(3a) Article 1(4) Article 1(4) and (5) Article 1(5) and (6) Point (a) of Article 2 Point (1) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (2) of Article 2 Point (b) of Article 2 Point (3) of Article 2 Point (c) of Article 2 Point (4) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (5) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (6) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (7) of Article 2 Point (d) of Article 2 Point (8) of Article 2 Point (da) of Article 2 Point (9) of Article 2 Point (e) of Article 2 Point (10) of Article 2 Point (ea) of Article 2 Point (11) of Article 2 Point (f) of Article 2 Point (12) of Article 2 Point (g) of Article 2 \u2014 Point (h) of Article 2 Point (13) of Article 2 Point (i) of Article 2 Point (14) of Article 2 Point (j) of Article 2 \u2014 Point (k) of Article 2 \u2014 Point (l) of Article 2 \u2014 Point (m) of Article 2 Point (15) of Article 2 Point (n) of Article 2 Point (16) of Article 2 Point (o) of Article 2 Point (17) of Article 2 Point (p) of Article 2 Point (18) of Article 2 Point (q) Article 2 Point (19) of Article 2 Point (r) Article 2 Point (20) of Article 2 Point (s) Article 2 Point (31) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (22) of Article 2 Article 3(1) Article 5(1) \u2014 \u2014 \u2014 \u2014 Article 5(2) Article 3(2) Article 6(1) Article 3(3) Article 6(2) Article 3(3a) first subparagraph Article 8(1) \u2014 \u2014 \u2014 \u2014 Article 8(2) \u2014 \u2014 \u2014 \u2014 Article 7(1) Article 3(3a) second subparagraph Article 7(2) and (3) Article 3(3a) third subparagraph Article 9(1) and (3) \u2014 \u2014 \u2014 \u2014 Article 9(2) Article 3(3b) Article 10(1) Article 3(3c) Article 10(2) Article 3(4) Article 5(3) Article 3(5) Article 11 Article 3(6) Article 5(4) Article 4 Article 31 Article 5 Article 20 \u2014 \u2014 \u2014 \u2014 Article 22 Article 6 Article 23 Article 7 Article 32 Article 7a Article 33 \u2014 \u2014 \u2014 \u2014 Point (c) of Article 33(5) Article 8(1) and (2) Article 3(1) and (2) Article 8(5) Article 3(3) Article 8a(1) and (2) Article 4(1) and (2) \u2014 \u2014 \u2014 \u2014 Article 4(3) Article 8a(3) Article 4(4) \u2014 \u2014 \u2014 \u2014 Article 29 Article 9(1) and (2) Article 45(1) and (2) \u2014 \u2014 \u2014 \u2014 Article 45(3) Article 9(3) Article 45(4) Article 9(4) and (5) Article 45(5) and (6) Article 9(6) and (7) \u2014 Article 9a \u2014 Article 9b(1) and (2) Article 51(1) and (2) Article 9b(3) Article 51(4) \u2014 \u2014 \u2014 \u2014 Article 51(3) Article 10(1) Article 95(1) Article 10(2) Article 95(3) \u2014 \u2014 \u2014 \u2014 Article 95(2) \u2014 \u2014 \u2014 \u2014 Article 95(4) \u2014 \u2014 \u2014 \u2014 Article 95(5) \u2014 \u2014 \u2014 \u2014 Article 95(6) Article 10(3) Article 95(7) Article 10(4) Article 95(8) Article 10(5) \u2014 Article 11 Article 43 Article 12(1) Article 44(1) Article 12(2) \u2014 Article 12(3) Article 61(2) Article 12(4) \u2014 Article 12(5) Article 44(2) Article 13 Article 17 Article 13a(1), (2) and (3) Article 40(1), (2) and (3) Article 13a(4) \u2014 \u2014 Article 40(5) \u2014 \u2014 \u2014 \u2014 Article 40(4) Article 13b(1), (2) and (3) Article 41(1), (2) and (3) \u2014 \u2014 \u2014 \u2014 Article 41(4) Article 13b(4) Article 41(7) \u2014 \u2014 \u2014 \u2014 Article 41(5) \u2014 \u2014 \u2014 \u2014 Article 41(6) Article 14 Article 63 Article 15(1),(2),(3) Article 64(1), (2), (3) Article 15 (4) \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 Article 66 Article 16 Article 67 Article 17 Article 39 Article 18 \u2014 Article 19 Article 38 Article 20 Article 26 Article 21(1) Article 27(1) Article 21(2) first and second subparagraphs Article 27(2) Article 21(2) third subparagraph Article 27(3) Article 21(2) fourth and fifth subparagraphs Article 27(4) \u2014 Article 27(5) Article 21(3) \u2014 Article 21(4) Article 27(6) Article 21a Article 29 Article 22(1) Article 118(1) Article 22(2) Article 118(3) Article 22(3) Article 118(4) \u2014 \u2014 \u2014 \u2014 Article 11(2) \u2014 \u2014 \u2014 \u2014 Article 118(5) \u2014 \u2014 \u2014 \u2014 Article 117 Article 23 Article 119 Article 24 Article 120(1) and (2) Article 25 Article 122(1) Article 26 Article 125 Article 28 Article 124 Article 29 Article 127 Article 30 Article 128 Annex II \u2014 Article 1 Article 1(1) Article 2(1) \u2014 Article 2(2) Point (22) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (23) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (24) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (25) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (26) of Article 2 Article 3(1) Article 12(1) Article 3(2) first sentence Article 12(2) Article 3(2) 2nd, 3rd and 4th sentences Article 12(3) Article 3(3) Article 12(4) \u2014 \u2014 \u2014 \u2014 Article 4 Article 15 Article 5(1) Article 46(1) \u2014 \u2014 \u2014 \u2014 Article 46(2) and (3) Article 5(2) first subparagraph Article 48(1) Article 5(2) second subparagraph first sentence Article 48(2) Article 5(2) third subparagraph Article 48(5) Article 5(2) second subparagraph second sentence Article 48(3) \u2014 \u2014 \u2014 \u2014 Article 48(4) Article 5(3) Article 48(6) Article 5(4) and (5) Article 93(4) and (5) Article 5(6) Article 52 \u2014 \u2014 \u2014 \u2014 Article 93 Article 6(1),(2),(3) and (4) Article 13 \u2014 \u2014 \u2014 \u2014 Article 47 Article 7 \u2014 \u2014 Article 55 Article 8 Article 36 Article 9 Article 14 Article 10 Article 30 \u2014 \u2014 \u2014 \u2014 Article 11 Article 21 Article 12 Article 16 Article 13 Article 42 \u2014 \u2014 \u2014 \u2014 Article 94 Article 14(1) Article 18 Article 14(2) Article 19 Article 15 Article 120(3) and (4) Article 16 \u2014 Article 17 \u2014 Article 18 \u2014 Article 19 \u2014 Article 20 \u2014 Annex Annex I Article 1 (1 and 2) Article 1(2) and (3) Point (a) of Article 2 Point (27) of Article 2 Point (b) of Article 2 Point (28) of Article 2 Point (c) of Article 2 Point (29) of Article 2 Point (d) of Article 2 \u2014 Point (e) of Article 2 Point (30) of Article 2 Article 3 Article 59 Article 4 Article 60 Article 5 Article 61 Article 6 Article 62 \u2014 Article 8 Article 68 Article 9 Article 69 Article 10 Article 70 Article 11 Article 71 \u2014 \u2014 \u2014 \u2014 Article 72 Article 12 Article 73 Article 13 Article 74 \u2014 \u2014 \u2014 \u2014 Article 75 \u2014 \u2014 \u2014 \u2014 Article 76 Article 13a Article 77 Article 13b Article 78 \u2014 \u2014 \u2014 \u2014 Article 80 \u2014 \u2014 \u2014 \u2014 Article 81 Article 14 \u2014 Article 15 Article 120(5) Article 16(1) \u2014 Article 16(2) Article 121(4) Article 17 \u2014 Article 18 \u2014 Article 19 \u2014 Article 20 \u2014 Annex I Annex II Annex II \u2014 \u2014 \u2014 \u2014 \u2014 Annex III Article 1 Article 1(4) and (5) Point (a) of Article 2 \u2014 Point (c) of Article 2 Point (32) of Article 2 Point (d) of Article 2 Point (33) of Article 2 Point (f) of Article 2 Point (34) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (35) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (37) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (38) of Article 2 \u2014 \u2014 \u2014 \u2014 Point (39) of Article 2 \u2014 \u2014 \u2014 \u2014 Article 84 \u2014 \u2014 \u2014 \u2014 Article 85 Article 3 Article 86(1) and (2) Article 4 \u2014 Article 5 \u2014 Article 6 \u2014 Article 7 \u2014 Article 8(1) Article 86(3) Article 8(2) Article 86(4) Article 8(3) Article 86(5) Article 9 \u2014 \u2014 \u2014 \u2014 \u2014 Article 87 Article 10 Article 88 Article 11 \u2014 Article 12 Article 89 Article 13 Article 90 Article 14 Article 91 Article 15 Article 122(2) and (3) Article 17 \u2014 \u2014 \u2014 \u2014 \u2014 Article 99 \u2014 \u2014 \u2014 \u2014 Article 101 Article 20(1) Article 102 Article 20(2) Article 105(3) Article 21 Article 103 Article 22 Article 104 Article 23 Article 108 Article 23a Article 111 Article 24 Article 113 Article 25 Article 112 Article 26 Article 109 Article 27 \u2014 Article 27a Article 96 Article 28 Article 97 Article 29 Article 115 Article 30(1) Article 106(2) Article 30(2) Article 106(4) Article 30(3) Article 106(4) Article 30(4) Article 106(5) Article 30(5) Article 105(1) Article 31 Article 114 Article 32 Article 92 Article 33 Article 24 Article 34 Article 25 Article 35 Article 116 Article 36 Article 121 Article 37 \u2014 Article 38 \u2014 Article 39 \u2014 Article 40 \u2014 Annex I Annex V Annex II Annex VII Annex III Annex IX Annex IV Annex VI Annex V \u2014 Annex VI Annex X Annex IV", "summary": "European Electronic Communications Code European Electronic Communications Code SUMMARY OF: Directive (EU) 2018/1972 establishing the European Electronic Communications Code WHAT IS THE AIM OF THE DIRECTIVE? The directive: establishes a set of updated rules to regulate electronic communications (telecoms) networks, telecoms services, and associated facilities and services; sets out tasks for national regulatory authorities and other competent authorities, and establishes a set of procedures to ensure that the regulatory framework is harmonised throughout the EU; aims to stimulate competition and increased investment in 5G* and very high capacity networks, so that every citizen and business in the EU can enjoy high quality connectivity, a high level of consumer protection and an increased choice of innovative digital services. KEY POINTS The directive establishes a European Electronic Communications Code, a comprehensive set of new or revised rules for the telecoms sector as part of a package of telecom laws, including Regulation (EU) 2018/1971 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Agency for Support for BEREC (BEREC Office). It replaces and repeals Directives 2002/19/EC, 2002/20/EC and 2002/21/EC, as well as Article 5 of Decision No 243/2012/EU. The review of Directive 2002/58/EC (Directive on privacy and electronic communications) is carried out separately. General objectives promote connectivity and take-up of very high capacity networks, including fixed, mobile and wireless networks, for all EU citizens and businesses; promote the interests of EU citizens by enabling maximum benefits in terms of choice, price and quality through effective competitionmaintaining network and services securityensuring protection for consumers through specific rules andaddressing the needs of specific social groups, in particular people with disabilities, older people and people with special social needs; facilitate market entry and promote competition in the delivery of telecoms networks and associated facilities; contribute to the development of the internal market in telecoms networks and services in the EU, by developing common rules and predictable regulation featuring: the effective, efficient and coordinated use of radio spectrum;open innovation;the development of trans-European networks;the availability and interoperability of Europe-wide services; andend-to-end connectivity. Responsibility of EU countries cooperate with each other and with the European Commission in the strategic planning and coordination of radio spectrum policy, avoiding harmful interference, through the Radio Spectrum Policy Group; ensure that tasks set out in the directive are undertaken by a competent authority; guarantee that national regulatory authorities and other competent authorities are independent of telecoms equipment manufacturers and service providers; ensure that the national regulatory authorities are protected against external intervention or political pressure which mightjeopardise their independent assessment andhave budget autonomy and adequate financial and human resources to carry out the tasks assigned to them. New objectives and tasks In addition to replacing and repealing existing legislation, the directive introduces a series of new objectives and tasks: Strengthened consumer rules aim to make it easier to switch between service providers and offer better protection, for example, for people who subscribe to bundled services. Consumers will benefit from a similar, higher level of protection across the EU. Telecoms services now include services provided over the internet which do not use calling numbers, such as messaging apps and email. A review mechanism aims to ensure that consumerrights remain robust and up-to-date as business models and consumer behaviour change. Affordable and adequate broadband internet access must be available to all consumers, irrespective of their location or income. People with disabilities should have equivalent access to telecoms services. EU countries will set up a public warning system to send alerts to citizens on their mobile phones in the event of a natural disaster or other major emergency in their area. EU countries must provide operators with predictable regulationfor radio spectrum licensing for wireless broadband for at least 20 years to promote investment, in particular in 5G connectivity; increased convergence of national selection procedures through a Peer Review Forum. New frequency bands for 5G connectivity for faster internet connections and better connectivity, as well as coordinated timing of spectrum licensing and a lighter regulatory regime for small mobile network equipment deployment. Rules on operator access to networks to encourage competition make it easier for companies to invest in new, very high capacity infrastructure (download speeds of 100 Mbps or more), including in remote areas, while ensuring effective market regulation. New tools will address issues that may arise in certain market circumstances. Symmetric regulation* will apply to electronic communications network providers in some very specific situations to ensure competition. FROM WHEN DOES THIS DIRECTIVE APPLY? It entered into force on 20 December 2018. Directive (EU) 2018/1972 recasts and replaces Directives 2002/19/EC, 2002/20/EC and 2002/21/EC (and their subsequent amendments) which had to become law in the EU countries by 2003. The new rules contained in Directive (EU) 2018/1972 apply and have to become law in the EU countries by 21 December 2020 BACKGROUND See also: Press release on EU\u2019s telecoms rules (European Commission) Political agreement on the rules shaping the telecommunication markets in the 5G era (European Commission) Factsheet: Spectrum in the EU (European Commission) Factsheet: More and better internet connectivity requires investments in high speed and quality networks (European Commission) Digital Economy and Society Index (DESI) (European Commission) Connectivity for a European Gigabit Society (European Commission) Electronic communications laws (European Commission). KEY TERMS 5G: the latest generation of cellular mobile communication, characterised by a high data rate, reduced latency, energy saving, cost reduction, higher system capacity and greater device connectivity. Symmetric regulation: the same regulation of all network providers (as opposed to asymmetric regulation which differentiates between providers, generally to provide a level playing field between providers of lesser and greater importance). MAIN DOCUMENT Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (Recast) (OJ L 321, 17.12.2018, pp. 36-214) RELATED DOCUMENTS Regulation (EU) 2018/1971 of the European Parliament and of the Council of 11 December 2018 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Agency for Support for BEREC (BEREC Office), amending Regulation (EU) 2015/2120 and repealing Regulation (EC) No 1211/2009 (OJ L 321, 17.12.2018, pp. 1-35) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, pp. 1-30) Regulation (EU) 2015/2120 of the European Parliament and of the Council of 25 November 2015 laying down measures concerning open internet access and amending Directive 2002/22/EC on universal service and users\u2019 rights relating to electronic communications networks and services and Regulation (EU) No 531/2012 on roaming on public mobile communications networks within the Union (OJ L 310, 26.11.2015, pp. 1-18) Successive amendments to Regulation (EU) 2015/2120 have been incorporated into the original document. This consolidated version is of documentary value only. Regulation (EU) 2015/758 of the European Parliament and of the Council of 29 April 2015 concerning type-approval requirements for the deployment of the eCall in-vehicle system based on the 112 service and amending Directive 2007/46/EC (OJ L 123, 19.5.2015, pp. 77-89) See consolidated version. Directive 2014/61/EU of the European Parliament and of the Council of 15 May 2014 on measures to reduce the cost of deploying high-speed electronic communications networks (OJ L 155, 23.5.2014, pp. 1-14) Regulation (EU) No 531/2012 of the European Parliament and of the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (OJ L 172, 30.6.2012, pp. 10-35) See consolidated version. Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, pp. 7-17) Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a regulatory framework for radio spectrum policy in the European Community (Radio Spectrum Decision) (OJ L 108, 24.4.2002, pp. 1-6) Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive) (OJ L 108, 24.4.2002, pp. 7-20) See consolidated version. Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive) (OJ L 108, 24.4.2002, pp. 21-32) See consolidated version. Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, pp. 33-50) See consolidated version. Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, pp. 37-47) See consolidated version. last update 05.06.2019"}
{"article": "9.7.2018 EN Official Journal of the European Union L 173/1 REGULATION (EU) 2018/956 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 June 2018 on the monitoring and reporting of CO2 emissions from and fuel consumption of new heavy-duty vehicles (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) A binding target of at least a 40 % domestic reduction in economy-wide greenhouse gas emissions by 2030 compared to 1990 was endorsed in the conclusions of the European Council of 23-24 October 2014 on the 2030 climate and energy policy framework, and this target was reconfirmed at the European Council meeting of 17-18 March 2016. (2) The European Council conclusions of 23-24 October 2014 provided that the target has to be delivered collectively by the Union in the most cost-effective manner possible, with the reductions in the system for greenhouse gas emission allowance trading within the Union (\u2018EU ETS\u2019) and non-ETS sectors amounting to 43 % and 30 % respectively by 2030 compared to 2005. The Paris Agreement (3), inter alia, sets out a long-term goal in line with the objective to keep the global average temperature increase well below 2 \u00b0C above pre-industrial levels and to pursue efforts to keep it to 1,5 \u00b0C above pre-industrial levels. It is necessary that all Member States participate in these efforts and that all sectors of the economy, including transport, contribute to achieving the emission reductions agreed by the European Council and to fulfilling the long-term objectives of the Paris Agreement. (3) The Commission\u2019s 2016 European Strategy for low-emission mobility sets the ambition that, by mid-century, greenhouse gas emissions from transport will need to be at least 60 % lower than in 1990, and be firmly on the path towards zero. (4) In order to meet that objective, it is appropriate to consider a range of different measures. In addition to setting CO2 emission standards for heavy-duty vehicles, namely lorries, buses and coaches, those measures could include other actions that contribute to improving the efficiency and lower the CO2 emissions of heavy-duty vehicles, such as load optimisation, platooning, training of drivers, the use of alternative fuels, fleet renewal schemes, low-rolling resistance tyres, congestion reduction and investments in infrastructure maintenance. (5) Greenhouse gas emissions from heavy-duty vehicles currently represent around a quarter of road transport emissions in the Union and, if no additional measures are taken, are expected to increase by 10 % between 2010 and 2030 and by 17 % between 2010 and 2050. Effective measures to curb emissions from heavy-duty vehicles need to be introduced in order to contribute to the necessary emission reductions in the transport sector. (6) In its 2014 Communication on a Strategy for reducing Heavy-Duty Vehicles\u2019 fuel consumption and CO2 emissions, the Commission recognised that a prerequisite to introducing such measures is a regulated procedure for the determination of CO2 emissions and fuel consumption. (7) Regulation (EC) No 595/2009 of the European Parliament and the Council (4) provides the framework for the setting up of such a regulated procedure. The measurements carried out in accordance with that procedure will provide robust and comparable CO2 emissions and fuel consumption data for each heavy-duty vehicle in respect of a significant part of the heavy-duty vehicle fleet in the Union. The purchaser of a specific heavy-duty vehicle and the respective Member State of registration will have access to that information, partially closing the knowledge gap. (8) Transport companies are, to a large extent, small and medium-sized enterprises. Moreover, they do not yet have access to standardised information to evaluate fuel efficiency technologies or to compare heavy-duty vehicles in order to make the best-informed purchasing decisions, thereby reducing their fuel bills, which account for more than a quarter of their operating costs. (9) Information on a heavy-duty vehicle\u2019s performance in terms of CO2 emissions and fuel consumption should be made publicly available to enable all vehicle operators to take well-informed purchasing decisions and to ensure a high level of transparency. All heavy-duty vehicle manufacturers will be able to compare their vehicles\u2019 performance with those of other makes. That will increase the incentives for innovation and encourage the development of more energy efficient heavy-duty vehicles, thereby increasing competitiveness. That information will also provide policy makers at Union and Member State level with a sound basis for developing policies to promote the uptake of more energy-efficient heavy-duty vehicles. (10) In order to acquire complete knowledge on the configuration of the heavy-duty vehicle fleet in the Union, its development over time and potential impact on CO2 emissions, it is appropriate that the competent authorities of the Member States monitor and report to the Commission data on the registration of all new heavy-duty vehicles and all new trailers, including data on powertrains as well as the relevant bodywork. (11) It is therefore appropriate that heavy-duty vehicle manufacturers monitor and report to the Commission the CO2 emissions and fuel consumption values determined for each new heavy-duty vehicle pursuant to Commission Regulation (EU) 2017/2400 (5). (12) The availability of data on CO2 emissions and fuel consumption for the different heavy-duty vehicle categories depends on when the categories will be covered by Regulation (EU) 2017/2400. In order to provide clarity and legal certainty concerning monitoring and reporting obligations for manufacturers, this Regulation should set out the starting years for monitoring and reporting for each heavy-duty vehicle category falling within its scope. Pursuant to Regulation (EU) 2017/2400, data will be available for certain new heavy-duty vehicles that are registered in 2019. Starting from that year, manufacturers should be required to monitor and report the technical data relating to those vehicles. For other heavy-duty vehicle categories and heavy-duty vehicle groups the data will only become available from a later date. A reasonable timeframe should be set for determining the starting years for the monitoring and reporting of data for those vehicle categories and vehicle groups. Given the technical complexity of developing the procedures for determining the CO2 emissions and fuel consumption of the remaining heavy-duty vehicle categories and heavy-duty vehicle groups, the timeframe should be set at seven years from the date of entry into force of this Regulation. (13) It is in the public interest that technical data essential for determining the CO2 emissions and fuel consumption performance of a heavy-duty vehicle be actively disseminated to the public to increase the transparency of the heavy-duty vehicle specifications and the related performance, and to foster competition among manufacturers. Data that are sensitive on the grounds of personal data protection and fair competition should not be published. Certain data related to the aerodynamic performance of heavy-duty vehicles should be made available to the public in a range format in order to take account of considerations of fair competition. The data reported should be made available to the public in an easily accessible manner and free of charge. This Regulation is without prejudice to the further rights of public access to environmental information, inter alia, in accordance with Regulation (EC) No 1367/2006 of the European Parliament and of the Council (6). (14) It is important that the monitoring and reporting system be user friendly for all transport operators regardless of their size and resources. Likewise, it is important that the Commission actively promote such a system in order to ensure that it has a meaningful impact on the sector and to raise awareness on the availability of the reported data. (15) The Commission\u2019s analysis of the data transmitted by Member States and manufacturers for the preceding calendar year should be presented to the public in a way to show clearly the performance of the heavy-duty vehicle fleet of the Union and of each Member State as well as that of each manufacturer. It should allow comparability within and between fleets in terms of the average fuel consumption and CO2 emissions for each heavy-duty vehicle group by mission profile. (16) It is essential that the CO2 emission and fuel consumption values determined pursuant to Regulation (EU) 2017/2400 correctly reflect the performance of heavy-duty vehicles. That Regulation therefore sets out provisions for verifying and ensuring the conformity of the simulation tool operation as well as of the CO2 emissions and fuel consumption related properties of the relevant components, separate technical units and systems. That verification procedure should include on-road testing. The new type approval framework as set out in Regulation (EU) 2018/858 of the European Parliament and of the Council (7) provides the means for ensuring that, in the case of deviations, remedial measures are taken by the manufacturer, and that in the case of non-compliance, the Commission is able to impose administrative fines. That new framework also acknowledges the importance of third parties being allowed to perform independent testing of vehicles and having access to necessary data. The Commission should monitor the results of such verification tests and should include an analysis of those results in its annual report. (17) It is important to ensure that the data monitored and reported be robust and reliable. The Commission should therefore have the means to verify and, where necessary, correct the final data. The monitoring requirements should therefore also provide for parameters that allow the data to be adequately traced and verified. (18) The Commission should have the possibility to impose an administrative fine where it finds that the data reported by the manufacturer deviates from the data recorded in the framework of Regulation (EC) No 595/2009 and, in particular, in accordance with Commission Regulation (EU) No 582/2011 (8) and Regulation (EU) 2017/2400 or where the manufacturer fails to deliver the required data within the applicable deadline. Those fines should be effective, proportionate and dissuasive. (19) Based on the experience gained from the monitoring and reporting of data on CO2 emissions pursuant to Regulation (EC) No 443/2009 of the European Parliament and of the Council (9) for new passenger cars and to Regulation (EU) No 510/2011 of the European Parliament and of the Council (10) for new light commercial vehicles, it is appropriate to confer on the European Environment Agency the responsibility for the exchange of such data with the competent authorities of the Member States and manufacturers, as well as for the management of the final database on behalf of the Commission. It is also appropriate to align as far as possible the monitoring and reporting procedures for heavy-duty vehicles with those already existing for light-duty vehicles. (20) In order to ensure uniform conditions for the implementation of the provisions of this Regulation on the verification and correction of the monitored data, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11). (21) In order to ensure that the data requirements and the monitoring and reporting procedure remain relevant over time for assessing the heavy-duty vehicle fleet\u2019s contribution to CO2 emissions, to ensure the availability of data on new and advanced CO2 reducing technologies and on the results of on-road verification tests and to ensure that the air drag value ranges remain relevant for information and comparability purposes, as well as to supplement the provisions on administrative fines, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of completing the starting years for the monitoring and reporting of the heavy-duty vehicle categories covered, of amending the data requirements and the monitoring and reporting procedure laid down in the Annexes to this Regulation, of specifying the data to be reported by the Member States for the monitoring of the results of on-road verification tests, of amending the air drag value ranges, and of defining the criteria, the calculation and the method of collection of administrative fines imposed on manufacturers. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (12). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (22) Since the objective of this Regulation, namely the monitoring and reporting of CO2 emissions and fuel consumption from new heavy-duty vehicles in the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation lays down the requirements for the monitoring and reporting of CO2 emissions from and fuel consumption of new heavy-duty vehicles registered in the Union. Article 2 Scope This Regulation applies to the monitoring and reporting by Member States and manufacturers of heavy-duty vehicles of data on new heavy-duty vehicles. It applies with regard to the following vehicle categories: (a) vehicles of categories M1, M2, N1 and N2 with a reference mass that exceeds 2 610 kg and which do not fall within the scope of Regulation (EC) No 715/2007 of the European Parliament and of the Council (13), and all vehicles of categories M3 and N3; (b) vehicles of categories O3 and O4. For the purposes of this Regulation, those vehicles are referred to as heavy-duty vehicles. Article 3 Definitions For the purposes of this Regulation, the definitions set out in Directive 2007/46/EC of the European Parliament and of the Council (14) and Regulation (EC) No 595/2009 apply. Article 4 Monitoring and reporting by Member States 1. Starting from 1 January 2019, and for each subsequent calendar year, Member States shall monitor the data specified in Part A of Annex I relating to new heavy-duty vehicles registered for the first time in the Union. By 28 February each year, starting in 2020, the competent authorities of the Member States shall report those data to the Commission in accordance with the reporting procedure set out in Annex II. Data relating to new heavy-duty vehicles that were registered previously outside the Union shall not be monitored and reported, unless that registration was made less than three months before registration in the Union. 2. The competent authorities responsible for the monitoring and reporting of data in accordance with this Regulation shall be those designated by the Member States in accordance with Article 8(7) of Regulation (EC) No 443/2009. Article 5 Monitoring and reporting by manufacturers 1. From the starting years set out in point 1 of Part B of Annex I, manufacturers of heavy-duty vehicles shall monitor, on a calendar year basis, the data specified in point 2 of Part B of Annex I, for each new heavy-duty vehicle. By 28 February each year, from the starting years set out in point 1 of Part B of Annex I, manufacturers of heavy-duty vehicles shall report those data for each new heavy-duty vehicle with a date of simulation falling within the preceding calendar year to the Commission in accordance with the reporting procedure set out in Annex II. The date of simulation shall be the date reported in accordance with data entry 71 in point 2 of Part B of Annex I. 2. Each manufacturer shall appoint a contact point for the purpose of reporting data in accordance with this Regulation. Article 6 Central Register for data on heavy-duty vehicles 1. The Commission shall keep a Central Register for the data on heavy-duty vehicles (\u2018the Register\u2019) reported in accordance with Articles 4 and 5. The Register shall be publicly available with the exception of data entry (a) specified in Part A of Annex I and data entries 1, 24, 25, 32, 33, 39 and 40 specified in point 2 of Part B of Annex I. With regard to data entry 23 specified in point 2 of Part B of Annex I, the value shall be made publicly available in a range format as set out in Part C of Annex I. 2. The Register shall be managed by the European Environment Agency on behalf of the Commission. Article 7 Monitoring of the results of on-road verification tests 1. The Commission shall monitor, where available, the results of on-road tests performed within the framework of Regulation (EC) No 595/2009 to verify the CO2 emissions and fuel consumption of new heavy-duty vehicles. 2. The Commission is empowered to adopt delegated acts in accordance with Article 13 in order to supplement this Regulation by specifying the data to be reported by the competent authorities of the Member States for the purposes of paragraph 1 of this Article. Article 8 Data quality 1. The competent authorities and manufacturers shall be responsible for the correctness and quality of the data they report pursuant to Articles 4 and 5. They shall inform the Commission without delay of any errors detected in the data reported. 2. The Commission shall carry out its own verification of the quality of the data reported pursuant to Articles 4 and 5. 3. Where the Commission is informed of errors in the data or finds, pursuant to its own verification, discrepancies in the dataset, it shall, where appropriate, take the necessary measures to correct the data published in the Register referred to in Article 6. 4. The Commission may, by means of implementing acts, determine the verification and correction measures referred to in paragraphs 2 and 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 12. Article 9 Administrative fines 1. The Commission may impose an administrative fine in each of the following cases: (a) where it finds that the data reported by the manufacturer pursuant to Article 5 of this Regulation deviate from the data resulting from the manufacturer\u2019s records file or the engine type-approval certificate issued within the framework of Regulation (EC) No 595/2009, and the deviation is intentional or due to serious negligence; (b) where the data are not submitted within the deadline applicable pursuant to Article 5(1) and the delay cannot be duly justified. The Commission shall, for the purposes of verifying the data referred to in point (a), consult with the relevant approval authorities. The administrative fines shall be effective, proportional and dissuasive and shall not exceed EUR 30 000 per heavy-duty vehicle concerned by deviating or delayed data as referred to in points (a) and (b). 2. The Commission shall, on the basis of the principles set out in paragraph 3 of this Article, adopt delegated acts in accordance with Article 13 to supplement this Regulation by laying down the procedure, methods for the calculation and collection of the administrative fines referred to in paragraph 1 of this Article. 3. The delegated acts referred to in paragraph 2 shall respect the following principles: (a) the procedure established by the Commission shall respect the right to good administration, and in particular the right to be heard and the right to have access to the file, while respecting the legitimate interests of confidentiality and of commercial secrets; (b) in calculating the appropriate administrative fine, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness, taking into consideration, where relevant, the seriousness and effects of the deviation or delay, the number of heavy-duty vehicles concerned by the deviating or delayed data, the good faith of the manufacturer, the degree of diligence and cooperation of the manufacturer, the repetition, frequency or duration of the deviation or the delay as well as prior sanctions imposed on the same manufacturer; (c) administrative fines shall be collected without undue delay by fixing deadlines for the payment and, as appropriate, including the possibility of splitting payments into several instalments and phases. 4. The amounts of the administrative fines shall be considered as revenue for the general budget of the Union. Article 10 Report 1. By 31 October every year, the Commission shall publish an annual report with its analysis of the data transmitted by Member States and manufacturers for the preceding calendar year. 2. The analysis shall indicate, as a minimum, the performance of the heavy-duty vehicle fleet of the Union as well as that of each Member State and each manufacturer in terms of the average fuel consumption and CO2 emissions for each heavy-duty vehicle group by mission profile, load and fuel combination. It shall also, where available, take into account data on the uptake of new and advanced CO2 reducing technologies, as well as of alternative powertrains. Moreover, it shall include an analysis of, where available, the results of on-road verification tests as monitored in accordance with Article 7. 3. The Commission shall prepare the analysis with the support of the European Environment Agency. Article 11 Amendment of the Annexes 1. The Commission is empowered to adopt delegated acts in accordance with Article 13 with a view to amending the Annexes for the purpose of: (a) updating or adjusting the data requirements specified in Part A and Part B of Annex I, where this is deemed necessary in order to provide for a thorough analysis in accordance with Article 10; (b) completing the starting years in point 1 of Part B of Annex I; (c) updating or adjusting the ranges set out in Part C of Annex I to take into account changes in heavy-duty vehicle design and ensure that the ranges remain relevant for information and comparability purposes; (d) adjusting the monitoring and reporting procedure set out in Annex II in order to take into account the experience gained from the application of this Regulation. 2. The delegated acts referred to in point (b) of paragraph 1 shall be adopted by 30 July 2025. Article 12 Committee procedure 1. The Commission shall be assisted by the Climate Change Committee established by Regulation (EU) No 525/2013 of the European Parliament and of the Council (15). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 13 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 7(2), 9(2) and 11(1) shall be conferred on the Commission for a period of seven years from 29 July 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 7(2), 9(2) and 11(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 7(2), 9(2) and 11(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 14 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 28 June 2018. For the European Parliament The President A. TAJANI For the Council The President L. PAVLOVA (1) OJ C 81, 2.3.2018, p. 95. (2) Position of the European Parliament of 12 June 2018 (not yet published in the Official Journal) and decision of the Council of 21 June 2018. (3) Paris Agreement (OJ L 282, 19.10.2016, p. 4). (4) Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, p. 1). (5) Commission Regulation (EU) 2017/2400 of 12 December 2017 implementing Regulation (EC) No 595/2009 of the European Parliament and of the Council as regards the determination of the CO2 emissions and fuel consumption of heavy-duty vehicles and amending Directive 2007/46/EC of the European Parliament and of the Council and Commission Regulation (EU) No 582/2011 (OJ L 349, 29.12.2017, p. 1). (6) Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13). (7) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1). (8) Commission Regulation (EU) No 582/2011 of 25 May 2011 implementing and amending Regulation (EC) No 595/2009 of the European Parliament and of the Council with respect to emissions from heavy duty vehicles (Euro VI) and amending Annexes I and III to Directive 2007/46/EC of the European Parliament and of the Council (OJ L 167, 25.6.2011, p. 1). (9) Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emission performance standards for new passenger cars as part of the Community\u2019s integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 140, 5.6.2009, p. 1). (10) Regulation (EU) No 510/2011 of the European Parliament and of the Council of 11 May 2011 setting emission performance standards for new light commercial vehicles as part of the Union\u2019s integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 145, 31.5.2011, p. 1). (11) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (12) OJ L 123, 12.5.2016, p. 1. (13) Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1). (14) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p. 1). (15) Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13). ANNEX I Rules on data to be monitored and reported PART A: DATA TO BE MONITORED AND REPORTED BY MEMBER STATES (a) vehicle identification numbers of all new heavy-duty vehicles as referred to in points (a) and (b) of the second paragraph of Article 2 that are registered in the Member State territory; (b) manufacturer name; (c) make (trade name of manufacturer); (d) the code for the bodywork as specified in entry 38 of the certificate of conformity, where available; (e) in the case of the heavy-duty vehicles referred to in point (a) of the second paragraph of Article 2, the information on the powerplant specified in entries 23, 23.1 and 26 of the certificate of conformity. PART B: DATA TO BE MONITORED AND REPORTED BY MANUFACTURERS OF HEAVY-DUTY VEHICLES 1. Starting years for the monitoring and reporting of data for the heavy-duty vehicle categories set out in points (a) and (b) of the second paragraph of Article 2: Category of heavy-duty vehicles Vehicle group in vehicle category (as referred to in Annex I to Regulation (EU) 2017/2400) Starting year Monitoring Starting year Reporting N1 \u2014 \u2014 \u2014 N2 1 and 2 2020 2021 N3 3 2020 2021 4, 5, 9 and 10 2019 2020 11, 12 and 16 2020 2021 M1 \u2014 \u2014 \u2014 M2 \u2014 \u2014 \u2014 M3 \u2014 \u2014 \u2014 O3 \u2014 \u2014 \u2014 O4 \u2014 \u2014 \u2014 2. Data to be monitored and reported: No Monitoring parameters Source Part I of Annex IV to Regulation (EU) 2017/2400, unless otherwise specified Description 1 Vehicle identification number (VIN) 1.1.3 Vehicle and component identification 2 Engine certification number 1.2.2 3 CdxA (1) certification number (if applicable) 1.8.3 4 Transmission certification number 1.3.2 5 Axle certification number 1.6.2 6 Tyre certification number, axle 1 1.9.2 7 Tyre certification number, axle 2 1.9.6 8 Tyre certification number, axle 3 1.9.10 9 Tyre certification number, axle 4 1.9.14 10 Vehicle category (N1, N2, N3, M1, M2, M3) 1.1.4 Vehicle classification 11 Axle configuration 1.1.5 12 Maximum gross vehicle weight (t) 1.1.6 13 Vehicle group 1.1.7 14 Name and address of manufacturer 1.1.1 Vehicle and chassis specification 15 Make (trade name of manufacturer) 1.1.7 Part II of Annex IV to Regulation (EU) 2017/2400 16 Corrected actual curb mass (kg) 1.1.8 17 Engine rated power (kW) 1.2.3 Main engine specifications 18 Engine idling speed (1/min) 1.2.4 19 Engine rated speed (1/min) 1.2.5 20 Engine capacity (ltr) 1.2.6 21 Engine reference fuel type (diesel/LPG/CNG\u2026) 1.2.7 22 Certification option used for generation of CdxA (standard values/measurement) 1.8.2 Aerodynamics 23 CdxA value (air drag value) 1.8.4 24 Name and address of transmission manufacturer \u2014 Main transmission specifications 25 Make (trade name of transmission manufacturer) \u2014 26 Certification option used for the generation of simulation tool loss maps (Option 1/Option 2/Option 3/Standard values) 1.3.3 27 Transmission type (SMT (2), AMT (3), APT (4) -S (5), APT-P (6)) 1.3.4 28 Number of gears 1.3.5 29 Transmission ratio final gear 1.3.6 30 Retarder type 1.3.7 31 Power take off (yes/no) 1.3.8 32 Name and address of axle manufacturer \u2014 Main axle specifications 33 Make (trade name of axle manufacturer) \u2014 34 Certification option used for the generation of a simulation tool loss map (standard values/measurement) 1.7.3 35 Axle type (e.g. standard single driven axle) 1.7.4 36 Axle ratio 1.7.5 37 Certification option used for the generation of a simulation tool loss map (standard values/measurement) 1.6.3 Angle drive specifications 38 Angle drive ratio 1.6.4 39 Name and address of tyre manufacturer \u2014 Main tyre specifications 40 Make (trade name of tyre manufacturer) \u2014 41 Tyre dimension axle 1 1.9.1 42 Specific rolling resistance coefficient (RRC) of all tyres on axle 1 1.9.3 43 Tyre dimension axle 2 1.9.4 44 Twin axle (yes/no) axle 2 1.9.5 45 Specific RRC of all tyres on axle 2 1.9.7 46 Tyre dimension axle 3 1.9.8 47 Twin axle (yes/no) axle 3 1.9.9 48 Specific RRC of all tyres on axle 3 1.9.11 49 Tyre dimension axle 4 1.9.12 50 Twin axle (yes/no) axle 4 1.9.13 51 Specific RRC of all tyres on axle 4 1.9.15 52 Engine cooling fan technology 1.10.1 Main auxiliary specifications 53 Steering pump technology 1.10.2 54 Electric system technology 1.10.3 55 Pneumatic system technology 1.10.4 56 Mission profile (long haul, long haul (EMS (7)), regional, regional (EMS), urban, municipal, construction) 2.1.1 Simulation parameters (for each mission profile/load/fuel combination) 57 Load (as defined in the simulation tool) (kg) 2.1.2 58 Fuel type (diesel/petrol/LPG/CNG/\u2026) 2.1.3 59 Total vehicle mass in simulation (kg) 2.1.4 60 Average speed (km/h) 2.2.1 Vehicle driving performance (for each mission profile/load/fuel combination) 61 Minimum instantaneous speed (km/h) 2.2.2 62 Maximum instantaneous speed (km/h) 2.2.3 63 Maximum deceleration (m/s2) 2.2.4 64 Maximum acceleration (m/s2) 2.2.5 65 Full load percentage on driving time 2.2.6 66 Total number of gear shifts 2.2.7 67 Total driven distance (km) 2.2.8 68 CO2 emissions (expressed in g/km, g/t-km, g/p-km, g/m3-km) 2.3.13-2.3.16 CO2 emissions and fuel consumption (for each mission profile/load/fuel combination) 69 Fuel consumption (expressed in g/km, g/t-km, g/p-km, g/m3-km, l/100km, l/t-km, l/p-km, l/m3-km, MJ/km, MJ/t-km, MJ/p-km, MJ/m3-km) 2.3.1-2.3.12 70 Simulation tool version (X.X.X.) 3.1.1 Software and user information 71 Date and time of the simulation 3.1.2 72 Number of licence to operate the simulation tool \u2014 73 Cryptographic hash of simulation tool result 3.1.4 74 Advanced CO2 reducing technologies \u2014 Vehicle CO2 reducing technologies 75 CO2 mass emission of the engine over WHTC (8) (g/kWh) Point 1.4.2 of the addendum to Appendix 5, or point 1.4.2 of the addendum to Appendix 7, to Annex I to Regulation (EU) No 582/2011, whichever is applicable Engine CO2 emission and specific fuel consumption 76 Fuel consumption of the engine over WHTC (g/kWh) Point 1.4.2 of the addendum to Appendix 5, or point 1.4.2 of the addendum to Appendix 7, to Annex I to Regulation (EU) No 582/2011, whichever is applicable 77 CO2 mass emission of the engine over WHSC (9) (g/kWh) Point 1.4.1 of the addendum to Appendix 5, or point 1.4.1 of the addendum to Appendix 7, to Annex I to Regulation (EU) No 582/2011, whichever is applicable 78 Fuel consumption of the engine over WHSC (g/kWh) Point 1.4.1 of the addendum to Appendix 5, or point 1.4.1 of the addendum to Appendix 7, to Annex I to Regulation (EU) No 582/2011, whichever is applicable PART C: AIR DRAG VALUE (CDXA) RANGES FOR THE PURPOSE OF PUBLICATION IN ACCORDANCE WITH ARTICLE 6 For the purpose of making publicly available the CdxA value specified in data entry 23 in accordance with Article 6, the Commission shall use the ranges defined in the following table containing the corresponding range for each CdxA value: Range CdxA value [m2] Min CdxA (CdxA \u2265 min CdxA) Max CdxA (CdxA < MaxCdxA) A1 0,00 3,00 A2 3,00 3,15 A3 3,15 3,31 A4 3,31 3,48 A5 3,48 3,65 A6 3,65 3,83 A7 3,83 4,02 A8 4,02 4,22 A9 4,22 4,43 A10 4,43 4,65 A11 4,65 4,88 A12 4,88 5,12 A13 5,12 5,38 A14 5,38 5,65 A15 5,65 5,93 A16 5,93 6,23 A17 6,23 6,54 A18 6,54 6,87 A19 6,87 7,21 A20 7,21 7,57 A21 7,57 7,95 A22 7,95 8,35 A23 8,35 8,77 A24 8,77 9,21 (1) Air drag. (2) Synchronised Manual Transmission. (3) Automated Manual Transmission or Automatic Mechanically-engaged Transmission. (4) Automatic Powershifting Transmission. (5) \u2018Case S\u2019 means the serial arrangement of a torque converter and the connected mechanical parts of the transmission. (6) \u2018Case P\u2019 means the parallel arrangement of a torque converter and the connected mechanical parts of the transmission (e.g. in power split installations). (7) European Modular System (EMS) in accordance with Council Directive 96/53/EC of 25 July 1996 laying down for certain road vehicles circulating within the Community the maximum authorized dimensions in national and international traffic and the maximum authorized weights in international traffic (OJ L 235, 17.9.1996, p. 59). (8) World Harmonized Transient Driving Cycle. (9) Worldwide Harmonised Steady state Cycle. ANNEX II Data reporting and management 1. REPORTING BY MEMBER STATES 1.1. The data specified in Part A of Annex I shall be transmitted in accordance with Article 4 by the contact point of the competent authority via electronic data transfer to the Central Data Repository managed by the European Environment Agency (\u2018the Agency\u2019). The contact point shall notify the Commission and the Agency when the data are transmitted by email to the following addresses: EC-CO2-HDV-IMPLEMENTATION@ec.europa.eu and HDV-monitoring@eea.europa.eu 2. REPORTING BY MANUFACTURERS 2.1. Manufacturers shall notify the Commission without delay and not later than by 31 December 2018 of the following information: (a) the manufacturer name indicated in the certificate of conformity or individual approval certificate; (b) the World Manufacturer Identifier code (WMI code) as defined in Commission Regulation (EU) No 19/2011 (1) to be used in the vehicle identification numbers of new heavy-duty vehicles to be placed on the market; (c) the contact point responsible for uploading the data to the Business Data Repository of the Agency. They shall notify the Commission without delay of any changes to that information. The notifications shall be sent to the addresses referred to in point 1.1. 2.2. New manufacturers entering the market shall inform the Commission without delay of the information referred to in point 2.1. 2.3. The data specified in point 2 of Part B of Annex I shall be transmitted in accordance with Article 5(1) by the contact point of the manufacturer via electronic data transfer to the Business Data Repository managed by the Agency. The contact point shall notify the Commission and the Agency when the data are transmitted by email to the addresses referred to in point 1.1. 3. DATA PROCESSING 3.1. The Agency shall process the data transmitted in accordance with points 1.1 and 2.3 and shall record the processed data in the Register. 3.2. The data relating to heavy-duty vehicles registered in the preceding calendar year and recorded in the Register shall be made public by 31 October each year, starting from 2020, with the exception of the data entries specified in Article 6(1). 3.3. Where a competent authority or manufacturers identify errors in the data submitted, they shall without delay notify those to the Commission and the Agency by submitting an error notification report to the Central Data Repository or the Business Data Repository and by email sent to the addresses referred to in point 1.1. 3.4. The Commission shall with the support of the Agency verify the notified errors and, where appropriate, correct the data in the Register. 3.5. The Commission, with the support of the Agency, shall make available electronic formats for the data transmissions referred to in points 1.1 and 2.3 in due time before the transmission deadlines. (1) Commission Regulation (EU) No 19/2011 of 11 January 2011 concerning type-approval requirements for the manufacturer\u2019s statutory plate and for the vehicle identification number of motor vehicles and their trailers and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 8, 12.1.2011, p. 1).", "summary": "Monitoring and reporting the CO2 emissions of heavy-duty vehicles Monitoring and reporting the CO2 emissions of heavy-duty vehicles SUMMARY OF: Regulation (EU) 2018/956 \u2014 monitoring and reporting CO2 emissions from, and fuel consumption of, new heavy-duty vehicles WHAT IS THE AIM OF THE REGULATION? It aims to: allow transport companies to make well-informed purchasing decisions by giving them access to standardised information on fuel consumption in order to compare different models of lorries, trucks and buses; encourage manufacturers to develop more energy-efficient heavy-duty vehicles (HDVs); enable public authorities to design and implement policies to promote more fuel-efficient heavy-duty vehicles, for instance through taxation and road-user charging. KEY POINTS Scope The regulation applies to heavy-duty vehicles, which include lorries, buses and coaches. Monitoring and reporting From 1 January 2019, and for each subsequent calendar year, EU countries must monitor certain registration data for new HDVs registered for the first time in the EU. From 2020, EU countries must submit such data to the European Commission each year in accordance with a standard reporting procedure. Manufacturers must also monitor and report each year to the Commission the CO2 and fuel consumption values, as well as additional relevant data, \u200b\u200bfor each new heavy-duty vehicle, as determined in accordance with Commission Regulation (EU) 2017/2400 (known as the Certification Regulation). The regulation sets out the starting years of monitoring and reporting by manufacturers for each category of HDV. Central register The data provided by EU countries and manufacturers will be set out in a publicly accessible central EU register. Exceptions to public accessibility must be justified by the need to protect private data and to ensure fair competition. On-road verification tests The Commission will monitor, where available, the results of on-road tests, performed under Regulation (EC) No 595/2009 \u2014 Emissions from heavy-duty vehicles (Euro VI), which are meant to verify that the CO2 emission and fuel consumption values determined according to Commission Regulation (EU) 2017/2400 correctly reflect the performance of HDVs. Fines The Commission can impose a fine where it finds that the data reported by the manufacturer does not match the data determined in accordance with Regulation (EC) No 595/2009, or where the data are not submitted within the applicable deadline. The fine must be effective, proportional and dissuasive and must not exceed \u20ac30.000 per heavy-duty vehicle concerned. FROM WHEN DOES THE REGULATION APPLY? It has applied since 29 July 2018. BACKGROUND Reducing CO2 emissions from heavy-duty vehicles (European Commission). MAIN DOCUMENT Regulation (EU) 2018/956 of the European Parliament and of the Council of 28 June 2018 on the monitoring and reporting of CO2 emissions from and fuel consumption of new heavy-duty vehicles (OJ L 173, 9.7.2018, pp. 1-15) RELATED DOCUMENTS Commission Regulation (EU) 2017/2400 of 12 December 2017 implementing Regulation (EC) No 595/2009 of the European Parliament and of the Council as regards the determination of the CO2 emissions and fuel consumption of heavy-duty vehicles and amending Directive 2007/46/EC of the European Parliament and of the Council and Commission Regulation (EU) No 582/2011 (OJ L 349, 29.12.2017, pp. 1-247) Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, pp. 1-13) Successive amendments to Regulation (EC) No 595/2009 have been incorporated into the original document. This consolidated version is of documentary value only. last update 21.12.2018"}
{"article": "28.10.2017 EN Official Journal of the European Union L 280/1 REGULATION (EU) 2017/1938 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2017 concerning measures to safeguard the security of gas supply and repealing Regulation (EU) No 994/2010 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Natural gas (gas) remains an essential component of the energy supply of the Union. A large proportion of such gas is imported into the Union from third countries. (2) A major disruption of gas supply can affect all Member States, the Union and Contracting Parties to the Treaty establishing the Energy Community, signed in Athens on 25 October 2005. It can also severely damage the Union economy and can have a major social impact, in particular on vulnerable groups of customers. (3) This Regulation aims to ensure that all the necessary measures are taken to safeguard an uninterrupted supply of gas throughout the Union, in particular to protected customers in the event of difficult climatic conditions or disruptions of the gas supply. Those objectives should be achieved through the most cost-effective measures and in such a way that gas markets are not distorted. (4) Union law, in particular Directive 2009/72/EC of the European Parliament and of the Council (3), Directive 2009/73/EC of the European Parliament and of the Council (4), Regulation (EC) No 713/2009 of the European Parliament and of the Council (5), Regulation (EC) No 714/2009 of the European Parliament and of the Council (6), Regulation (EC) No 715/2009 of the European Parliament and of the Council (7) and Regulation (EU)No 994/2010 of the European Parliament and of the Council (8), has already had a significant positive impact on the security of gas supply in the Union, both in terms of preparation and mitigation. Member States are better prepared to face a supply crisis now that they are required to establish preventive action plans and emergency plans, and they are better protected now that they have to meet a number of obligations regarding infrastructure capacity and gas supply. However, the Commission's report on the implementation of Regulation (EU) No 994/2010 of October 2014 highlighted areas in which improvements to that Regulation could further bolster the security of gas supply in the Union. (5) The Commission's communication of 16 October 2014 on the short-term resilience of the European gas system analysed the effects of a partial or complete disruption of gas supplies from Russia and concluded that purely national approaches are not very effective in the event of severe disruption, given their scope, which is by definition limited. The stress test showed how a more cooperative approach among Member States could significantly reduce the impact of very severe disruption scenarios in the most vulnerable Member States. (6) Energy security constitutes one of the objectives of the Energy Union Strategy, as set out in the Commission's communication of 25 February 2015 on a Framework Strategy for a Resilient Energy Union with a Forward-Looking Climate Change Policy, which also emphasised the \u2018energy efficiency first\u2019 principle and the need to fully implement existing Union energy legal acts. The communication highlighted the fact that the Energy Union rests on solidarity, enshrined in Article 194 of the Treaty on the Functioning of the European Union (TFEU), and trust, which are necessary features of energy security. This Regulation is intended to boost solidarity and trust between the Member States and put in place the measures needed to achieve those aims. When assessing the preventive action plans and the emergency plans established by the Member States, the Commission should also be able to draw the attention of the Member States to the objectives of the Energy Union. (7) An internal gas market that operates smoothly is the best guarantee of the security of gas supply across the Union and to reduce the exposure of individual Member States to the harmful effects of disruptions of gas supply. Where a Member State's security of gas supply is threatened, there is a risk that measures developed unilaterally by that Member State may jeopardise the proper functioning of the internal gas market and damage the gas supply to customers in other Member States. To allow the internal gas market to function even in the face of a shortage of supply, provision must be made for solidarity and coordination in the response to supply crises, as regards both preventive action and the reaction to actual disruptions of gas supply. (8) A truly interconnected internal energy market with multiple entry points and reverse flows can be created only by fully interconnecting its gas grids, by building up liquefied natural gas (LNG) hubs in the Union's Southern and Eastern regions, by completing the North-South and Southern Gas corridors and by further developing domestic production. Therefore, an accelerated development of interconnections and projects aiming to diversify supply sources, as already shortlisted in the Energy Security Strategy, is necessary. (9) So far, the potential for more efficient and less costly measures through regional cooperation has not been fully exploited. This has to do not only with better coordination of national mitigation actions in emergency situations, but also with national preventive measures, such as national storage or policies related to LNG, which can be strategically important in certain regions of the Union. (10) In a spirit of solidarity, regional cooperation, involving both public authorities and natural gas undertakings, should be the guiding principle of this Regulation, to mitigate the identified risks and optimise the benefits of coordinated measures and to implement the most cost-effective measures for Union consumers. Regional cooperation should gradually be complemented with a stronger Union perspective, allowing recourse to all available supplies and tools in the entire internal gas market. Union-level assessment of the emergency supply corridors should be incorporated into the regional cooperation. (11) A risk-based approach to assessing the security of supply and establishing preventive and mitigating measures enables efforts to be coordinated and brings significant benefits in terms of the effectiveness of measures and optimisation of resources. This applies particularly to measures designed to guarantee a continued supply, under very demanding conditions, to protected customers, and to measures to mitigate the impact of an emergency. Assessing correlated risks jointly in risk groups which is both more comprehensive and more precise, will ensure that Member States are better prepared for any crises. Moreover, in an emergency, a coordinated and pre-agreed approach to the security of supply ensures a consistent response and reduces the risk of negative spill-over effects that purely national measures could have in neighbouring Member States. (12) For the purpose of the risk-based approach, risk groups should be defined based on the major transnational risks to the security of gas supply in the Union. Such risks were identified in the Commission's communication of 16 October 2014 on the short-term resilience of the European gas system and the assessment included in the latest Ten-Year Network Development Plan (TYNDP) developed by the European Network of Transmission System Operators for Gas (ENTSOG). To allow for a more precise and better focused assessment for the purposes of this Regulation, the risk groups should be composed on the basis of the main gas supply sources and routes. (13) To provide input to the common and national risk assessments, ENTSOG, in consultation with the Gas Coordination Group (GCG) and with the European Network of Transmission System Operators for Electricity (ENTSO-E), should carry out a Union-wide simulation of gas supply and infrastructure disruption scenarios. Such a simulation should be repeated at least every two years. As a means of strengthening regional cooperation by providing information about gas flows as well as providing technical and operational expertise, the Regional Coordination System for Gas (ReCo System for Gas), established by ENTSOG and composed of standing expert groups, should be involved in carrying out simulations. ENTSOG should ensure an appropriate level of transparency and access to the modelling assumptions used in its scenarios. (14) The Commission should be empowered to update the composition of the risk groups by means of a delegated act based on the evolution of the major transnational risks to the security of gas supply in the Union and its impact on Member States, taking into account the result of the Union-wide simulation and the discussion within the GCG. (15) In order to make the regional cooperation feasible, Member States should agree on a cooperation mechanism within each risk group. Such a mechanism should be developed sufficiently in time to allow for conducting the common risk assessment and discussing and agreeing on appropriate and effective cross-border measures, which will require the agreement of each Member State concerned, to be included in the regional chapters of the preventive action plans and the emergency plans, after consulting the Commission. Member States are free to agree on a cooperation mechanism best suited to a given risk group. The Commission should be able to have a facilitating role in the overall process and share best practices for arranging regional cooperation such as a rotating coordination role within the risk groups for the preparation of the different documents or establishing dedicated bodies. In the absence of an agreement on the cooperation mechanism, the Commission should propose a suitable cooperation mechanism for a given risk group. (16) When conducting the common risk assessment, competent authorities should assess all relevant risk factors which could lead to the materialisation of the major transnational risk for which the risk group was created, including disruption of gas supply from the single largest supplier. Those risk factors should be addressed by appropriate cross-border measures agreed by the competent authorities of the Member States concerned. The cross-border measures should be included in the regional chapters of the preventive action plans and the emergency plans. In addition, the competent authorities should conduct a comprehensive national risk assessment and assess natural, technological, commercial, financial, social, political and market-related risks, andany other relevant ones. All risks should be addressed by effective, proportionate and non-discriminatory measures to be developed in the preventive action plans and the emergency plans. The results of the common and national risk assessments should also contribute to the all hazard risk assessments provided for in Article 6 of Decision No 1313/2013/EU of the European Parliament and of the Council (9) and should be fully taken into account in the national risk assessments. (17) To ensure maximum preparedness, so as to avoid a disruption of gas supply and mitigate its effects should it nevertheless occur, the competent authorities of a given risk group should, after consulting stakeholders, establish preventive action plans and emergency plans that will contain regional chapters. They should be designed so as to address national risks in a way that takes full advantage of the opportunities provided by regional cooperation.The plans should be technical and operational in nature, their function being to help prevent the occurrence or escalation of an emergency or to mitigate its effects. The plans should take the security of electricity systems into account and should be consistent with the Energy Union's strategic planning and reporting tools. (18) When establishing and implementing the preventive action plans and the emergency plans, the competent authorities should, at all times, take account of the safe operation of the gas system at regional and national levels. They should address and set out in those plans the technical constraints affecting the operation of the network, including any technical and safety reasons for reducing flows in the event of an emergency. (19) The Commission should assess the preventive action plans and the emergency plans duly taking into account the views expressed in the GCG and recommend their review, in particular if the plans do not effectively address the risks identified in the risk assessment, if they distort competition or hamper the functioning of the internal energy market, if they endanger the security of gas supply of other Member States or if they do not comply with the provisions of this Regulation or other Union law. The competent authority of the Member State should take account of the Commission's recommendations. Where, following the final position of the competent authority, the Commission concludes that the measure in question would endanger the security of gas supply of another Member State or the Union, the Commission should continue the dialogue with the Member State concerned for it to agree to amend or withdraw the measure. (20) The preventive action plans and the emergency plans should be updated regularly and published. To ensure that the emergency plans are always up-to-date and effective, Member States should carry out at least one test between the updates of the plans by simulating high and medium-impact scenarios and responses in real time. The competent authorities should present the test results at the GCG. (21) Mandatory comprehensive templates including all the risks to be covered by the risk assessment and all the components of the preventive action plans and the emergency plans are needed to facilitate the risk assessment and preparation of the plans and their assessment by the Commission. (22) To facilitate communication between Member States and the Commission, the risk assessments, the preventive action plans, the emergency plans and all other documents and information exchanges provided for in this Regulation should be notified using a secure and standardised electronic notification system. (23) Certain customers, including households and customers providing essential social services are particularly vulnerable and may need protection against the negative effects of disruption of gas supply. A definition of such protected customers should not conflict with the Union solidarity mechanisms. (24) It is appropriate to narrow down the definition of customers protected under the solidarity mechanism. This is required by the obligation of Member States to provide solidarity in the case of extreme circumstances and for essential needs. The definition of solidarity protected customers should therefore be limited to households while still being able to include, under specific conditions, certain essential social services and district heating installations. It is therefore possible for Member States to treat, in accordance with that framework, healthcare, essential social care, emergency and security services as solidarity protected customers, including where those services are performed by a public administration. (25) Responsibility for the security of gas supply should be shared by natural gas undertakings, Member States, acting through their competent authorities, and the Commission, within their respective remits. Such shared responsibility requires very close cooperation between those parties. However, customers using gas for electricity generation or industrial purposes may also have an important role to play in the security of gas supply, as they can respond to a crisis by taking demand-side measures, such as interruptible contracts and fuel switching, which have an immediate impact on the balance of demand and supply. Moreover, the security of gas supply to certain customers using gas for electricity generation may also be considered to be essential in some cases. In an emergency, it should be possible for a Member State to prioritise gas supply to such customers under certain conditions even over the gas supply to protected customers. In exceptional circumstances gas supply to some of such customers prioritised in an emergency over protected customers may also continue in a Member State providing solidarity to avoid severe damage to the functioning of the electricity or gas system in that Member State. Such a specific measure should be without prejudice to Directive 2005/89/EC of the European Parliament and of the Council (10). (26) The competent authorities should cooperate closely with other relevant national authorities, in particular national regulatory authorities, when carrying out the tasks specified in this Regulation. (27) The infrastructure standard should oblige Member States to maintain a minimum level of infrastructure such as to ensure a degree of redundancy in the system in the event of a disruption of the single largest gas infrastructure. As an analysis conducted on the basis of the N \u2013 1 formula constitutes a purely capacity-based-approach, the results of N \u2013 1 formula should be complemented with a detailed analysis that also captures gas flows. (28) Regulation (EU) No 994/2010 requires transmission system operators to enable permanent physical bi-directional capacity on all cross-border interconnections unless an exemption has been granted from that obligation. It aims to ensure that the possible benefits of permanent bi-directional capacity are always taken into account when a new interconnection is planned. However, bi-directional capacity can be used to supply gas both to the neighbouring Member State and to others along the gas supply corridor. The benefits to the security of gas supply of enabling permanent physical bi-directional capacity need to be seen from a broader perspective, in a spirit of solidarity and enhanced cooperation. A comprehensive cost-benefit analysis that takes account of the whole transportation corridor should be conducted when considering whether to implement bi-directional capacity. The competent authorities concerned should be required to re-examine the exemptions granted under Regulation (EU) No 994/2010 on the basis of the results of the common risk assessments. The overall objective should be to have a growing bi-directional capacity and keep one-directional capacity in future cross-border projects to a minimum. (29) Capacity at an interconnection point to a Member State may compete with capacity at exit points from the gas grid into a gas storage facility. As a consequence, a situation could arise where firm booking of exit capacity into storage reduces the technically available capacity to be allocated at the interconnection point. In order to ensure a higher level of energy security in an emergency, this Regulation should provide for a clear priority rule. Any booked capacity at interconnection points should be given priority over competing capacity at an exit point into a storage facility, thereby enabling the transmission system operator to allocate the maximum technical capacity at the interconnection point in order to enable higher gas flows into the neighbouring Member State which has declared an emergency. This may have the consequence that gas injections into storage cannot take place or can take place only with reduced volumes despite being firmly booked in advance. To compensate for the resulting financial loss, this Regulation should provide for a fair compensation to be applied directly and promptly between the affected system users. The transmission system operators concerned should cooperate in accordance with the relevant legal acts in order to apply that priority rule. (30) Council Directive 2008/114/EC (11) lays down a process with a view to enhancing the security of designated European critical infrastructures, including certain gas infrastructure, in the Union. Directive 2008/114/EC together with this Regulation contributes to creating a comprehensive approach to the energy security of the Union. (31) This Regulation lays down security of supply standards that are sufficiently harmonised and cover at least the situation that occurred in January 2009 when gas supply from Russia was disrupted. Those standards take account of the difference between Member States, public service obligations and customer protection measures, as referred to in Article 3 of Directive 2009/73/EC. Security of supply standards should be stable, so as to provide the necessary legal certainty, should be clearly defined, and should not impose unreasonable and disproportionate burdens on natural gas undertakings. They should also guarantee equal access for the Union natural gas undertakings to national customers. Member States should establish measures that will, in an effective and proportionate manner, ensure that natural gas undertakings comply with such a standard, including the possibility to establish fines on suppliers, where they consider it to be appropriate. (32) The roles and responsibilities of all natural gas undertakings and competent authorities should be defined precisely in order to keep the internal gas market functioning properly, particularly in the event of supply disruptions and crises. Such roles and responsibilities should be established in such a way so as to ensure that a three-level approach is respected which would involve, first, the relevant natural gas undertakings and industry, second, Member States at national or regional level, and third, the Union. This Regulation should enable natural gas undertakings and customers to rely on market-based mechanisms for as long as possible when coping with disruptions. However, it should also provide for mechanisms that can be deployed when markets alone are no longer able to deal adequately with a disruption of gas supply. (33) In the event of a disruption of gas supply, market players should be given sufficient opportunity to respond to the situation with market-based measures. Where market-based measures have been exhausted and they are still insufficient, Member States and their competent authorities should take measures to remove or mitigate the effects of a disruption of gas supply. (34) Where Member States plan to introduce non-market-based measures, the introduction of such measures should be accompanied by a description of their economic impact. This ensures customers have the information they need about the costs of such measures and ensures that the measures are transparent, especially as regards their impact on the gas price. (35) The Commission should have the power to ensure that new preventive non-market-based measures do not endanger the security of gas supply of other Member States or in the Union. Given that such measures can be particularly damaging to the security of gas supply, it is appropriate that they enter into force only when they are approved by the Commission or have been amended in accordance with a Commission decision. (36) Demand-side measures, such as fuel switching or reducing the gas supply to large industrial customers in an economically efficient order, may have a valuable role to play in ensuring the security of gas supply, if they can be applied quickly and significantly reduce demand in response to a disruption of gas supply. More should be done to promote efficient energy use, particularly where demand-side measures are needed. The environmental impact of any demand and supply-side measures proposed should be taken into account, with preference being given, as far as possible, to measures that have least impact on the environment. At the same time, aspects of the security of gas supply and competitiveness should be taken into account. (37) It is necessary to ensure the predictability of the action to take in the event of an emergency, allowing all market participants sufficient opportunity to react to and prepare for such circumstances. As a rule, the competent authorities should therefore act in accordance with their emergency plan. In duly justified exceptional circumstances, they should be allowed to take action which deviates from those plans. It is also important to make the way in which emergencies are declared more transparent and predictable. Information on the system balancing position (the overall status of the transmission network), the framework for which is set out in Commission Regulation (EU) No 312/2014 (12), may play an important role in that regard. That information should be available to the competent authorities and, where they are not the competent authorities, the national regulatory authorities, on a real time basis. (38) As demonstrated in the context of the October 2014 stress test exercise, solidarity is needed to ensure the security of gas supply in the Union. It spreads effects out more evenly and reduces overall effects of a severe disruption. The solidarity mechanism is designed to address extreme situations in which supply to solidarityprotected customers as an essential need and a necessary priority is at stake in a Member State. Solidarity ensures cooperation with more vulnerable Member States. At the same time, solidarity is a measure of last resort that applies only in an emergency and only under restrictive conditions. If an emergency is declared in a Member State, a gradual and proportionate approach should therefore be applied to ensure the security of gas supply. The Member State that declared the emergency should, in particular, first implement all emergency measures provided for in its emergency plan in order to ensure gas supply to its solidarity protected customers. At the same time, all Member States which have introduced an increased supply standard should temporarily reduce it to the normal supply standard to make the gas market more liquid, in the event that the Member State declaring the emergency indicates that cross-border action is required. If those two sets of measures fail to provide the necessary supply, solidarity measures by directly connected Member States should be taken to ensure gas supply to solidarity protected customers in the Member State experiencing the emergency, at that Member State's request. Such solidarity measures should consist in ensuring that the gas supply to customers other than solidarity protected customers in the territory of the Member State providing solidarity is reduced or does not continue, in order to free up gas volumes, to the extent necessary and for as long as the gas supply to solidarity protected customers in the Member State requesting solidarity is not satisfied. Nothing in this Regulation should be understood as requiring or enabling a Member State to exercise public authority in another Member State. (39) Solidarity measures should also be taken as a last resort where a Member State is connected to another Member State via a third country unless flows are restricted through the third country, and where there is agreement of the relevant Member States, who should involve, as appropriate, the third country through which they are connected. (40) Where solidarity measures are taken as a last resort, the reduction or discontinuation of gas supply in the Member State providing solidarity should, where necessary for the Member State to comply with its solidarity obligations, and in order to avoid discriminatory treatment, be applicable to all customers which are not solidarity protected customers, irrespective of whether they receive gas directly or through solidarity protected district heating installations in the form of heating. The same should be ensured vice versa as regards customers, which are not solidarity protected customers in the Member State receiving gas under the solidarity mechanism. (41) Where solidarity measures are taken as a last resort, it is preferable that the gas consumption in the Member State providing solidarity is, as a first step, reduced on a voluntary basis, by means of market-based measures, such as voluntary demand-side measures or reversed auctions, in which certain customers such as industrial customers would indicate to the transmission system operator or another authority responsible the price at which they would reduce or stop their gas consumption. If market-based measures are found to be insufficient to address the deficit in required gas supply, and given the importance of solidarity measures as a last resort, the Member State providing solidarity should as a second step, be able to make use of non-market-based measures, including curtailment of certain groups of customers, in order to comply with its solidarity obligations. (42) Solidarity measures of a last resort should be provided on the basis of compensation. The Member State providing solidarity should be paid fair compensation promptly by the Member State receiving solidarity, including for the gas delivered into its territory and all other relevant and reasonable costs incurred when providing solidarity. Solidarity measures of a last resort should be subject to the condition that the Member State requesting solidarity undertakes to pay such fair and prompt compensation. This Regulation does not harmonise all aspects of fair compensation. Member States concerned should adopt the necessary measures, in particular technical, legal and financial arrangements, to implement the provisions on prompt and fair compensation between them. (43) When taking solidarity measures pursuant to the provisions of this Regulation, Member States are implementing Union law and are therefore bound to respect fundamental rights guaranteed by Union law. Such measures may therefore give rise to an obligation for a Member State to pay compensation to those affected by its measures. Member States should therefore ensure that national compensation rules are in place which are in conformity with Union law, in particular with fundamental rights. Moreover, it should be ensured that the Member State receiving solidarity ultimately bears all reasonable costs incurred from the said obligation on the Member State providing solidarity to pay compensation and further reasonable costs incurred from the payment of compensation pursuant to the said national compensation rules. (44) Since there may be more than one Member State providing solidarity to a requesting Member State, there should be a burden-sharing mechanism. Under that mechanism, the Member State requesting solidarity should, after consulting all Member States concerned, seek the most advantageous offer on the basis of cost, speed of delivery, reliability and diversification of supplies of gas from different Member States. The Member States should provide such offers on the basis of voluntary demand-side measures as much as and for as long as possible, before resorting to non-market-based measures. (45) This Regulation introduces, for the first time, such a solidarity mechanism between Member States as an instrument to mitigate the effects of a severe emergency within the Union including a burden-sharing mechanism. The Commission should therefore review the burden-sharing mechanism and the solidarity mechanism in general in the light of future experience with their functioning, and propose, where appropriate, modifications thereto. (46) Member States should adopt the necessary measures for the implementation of the provisions concerning the solidarity mechanism, including by the Member States concerned agreeing on technical, legal and financial arrangements. Member States should describe the details of those arrangements in their emergency plans. The Commission should prepare legally non-binding guidance concerning the key elements that should be included in such arrangements. (47) For as long as a Member State can cover the gas consumption of its solidarity protected customers from its own production and therefore does not need to request solidarity, it should be exempt from the obligation to conclude technical, legal and financial arrangements with other Member States for the purpose of it receiving solidarity. This should not affect the obligation of the relevant Member State to provide solidarity to other Member States. (48) There should be a safeguard for the event that the Union might incur costs by virtue of a liability, other than for unlawful acts or conduct pursuant to the second paragraph of Article 340 TFEU, in respect of measures that Member States are required to take pursuant to the provisions of this Regulation on the solidarity mechanism. Regarding such instances, it is appropriate that the Member State receiving solidarity reimburse the costs of the Union. (49) Solidarity should also, where needed, take the form of civil protection assistance provided by the Union and its Member States. Such assistance should be facilitated and coordinated by the Union Civil Protection Mechanism established by Decision No 1313/2013/EU aiming to strengthen the cooperation between the Union and the Member States and to facilitate coordination in the field of civil protection in order to improve the effectiveness of systems for preventing, preparing for, and responding to natural and man-made disasters. (50) To assess the security of gas supply of a Member State or in part or the whole of the Union, access to the relevant information is essential. In particular, Member States and the Commission need regular access to information from natural gas undertakings regarding the main parameters of the gas supply, including accurate measurements of the available stored reserves, as a fundamental input in the design of security of gas supply policies. On reasonable grounds, irrespective of a declaration of an emergency, access should also be possible to additional information needed to assess the overall gas supply situation. That additional information would typically be non-price-related gas delivery information, such as minimum and maximum gas volumes, delivery points or conditions for the suspension of gas deliveries. (51) An efficient and targeted mechanism for access by Member States and the Commission to key gas supply contracts should ensure a comprehensive assessment of relevant risks that can lead to a disruption of gas supply or interfere with the necessary mitigating measures should a crisis nevertheless occur. Under that mechanism, certain key gas supply contracts should be automatically notified, irrespective of the origin of the gas, within or outside the Union, to the competent authority of the most affected Member States. New contracts or modifications should be notified immediately after their conclusion. In order to ensure transparency and reliability, existing contracts should also be notified. The notification obligation should also cover all commercial agreements that are relevant for the execution of the gas supply contract, including relevant agreements that may be related to infrastructure, storage and any other aspect important for the security of gas supply. (52) Any obligation to notify a contract automatically to the competent authority needs to be proportionate. Applying that obligation to contracts between a supplier and a buyer covering the equivalent of 28 % or more of yearly gas consumption in the national market strikes the right balance in terms of administrative efficiency and transparency and lays down clear obligations for market participants. The competent authority should assess the contract for security of gas supply purposes and submit the results of the assessment to the Commission. If thecompetent authority has doubts as to whether a contract puts the security of gas supply of the Member State or a region at risk it should notify the contract to the Commission for assessment. This does not mean that other gas supply contracts are not relevant to the security of gas supply. Accordingly, where the competent authority of the most affected Member State or the Commission considers that a gas supply contract which is not subject to automatic notification under this Regulation might, due to its specificity, the customer group served, or its relevance for the security of gas supply, put at risk the security of gas supply of a Member State, of a region or of the Union, the competent authority or the Commission should be able to request that contract in order to assess its impact on the security of gas supply. It could, for example, be requested in the event of changes in the pattern of the gas supply to a given buyer or buyers in a Member State which would not be expected if the markets were functioning normally and which could affect the gas supply of the Union or parts of it. Such mechanism will ensure that the access to other key gas supply contracts relevant for the security of supply is guaranteed. Such a request should be reasoned, taking into account the need to limit the administrative burden of that measure as much as possible. (53) The Commission may propose that the Member States amend the risk assessments and the preventive action plans and the emergency plans so as to take account of the information obtained from the contracts. The provisions of this Regulation should be without prejudice to the right of the Commission to launch infringement proceedings in accordance with Article 258 TFEU and to enforce competition, including State aid, rules. (54) All contracts or contractual information received in that framework, including the assessments by the competent authority or the Commission, should remain confidential, in particular in order to protect commercially sensitive information and the integrity and proper functioning of the system of information exchange. Such confidentiality can also be relevant for public security given the importance an essential commodity such as gas may have for Member States. Moreover, meaningful and comprehensive assessments by the competent authorities or the Commission will contain, in particular, information relating to public security, commercial information or reference thereto. It is therefore necessary to ensure the confidentiality of the assessments. It is equally important that those who receive confidential information in accordance with this Regulation are bound by the obligation of professional secrecy. The Commission, competent authorities and national regulatory authorities, bodies or persons which receive confidential information pursuant to this Regulation should ensure the confidentiality of the information which they receive. (55) There should be a proportionate system of crisis management and information exchange based on three crisis levels: early warning, alert and emergency. Where the competent authority of a Member State declares one of the crisis levels, it should immediately inform the Commission as well as the competent authorities of the Member States to which the Member State of that competent authority is directly connected. In the case of a declaration of an emergency, the Member States in the risk group should also be informed. The Commission should declare a regional or Union emergency at the request of at least two competent authorities that have declared an emergency. To ensure an appropriate level of information exchange and cooperation in the case of regional or Union emergency the Commission should coordinate the action of the competent authorities, taking full account of relevant information from, and the results of, the consultation of the GCG. The Commission should declare an end to the regional or Union emergency if, after an assessment of the situation, it concludes that a declaration of an emergency is no longer justified. (56) The GCG should act as an adviser to the Commission to help coordinate security of gas supply measures in the event of a Union emergency. It should also monitor the adequacy and appropriateness of measures to be taken under this Regulation, including the consistency of preventive action plans and emergency plans drawn up by different risk groups. (57) A gas crisis could extend beyond Union borders, also comprising Energy Community Contracting Parties. As a Party to the Energy Community Treaty, the Union should promote amendments to that Treaty with the aim of creating an integrated market and a single regulatory space by providing an appropriate and stable regulatory framework. In order to ensure that an efficient crisis management on borders between the Member States and the Contracting Parties exists in the meantime, they are invited to closely cooperate when preventing, preparing for and handling a gas crisis. (58) Since gas supplies from third countries are central to the security of gas supply in the Union, the Commission should coordinate action with regard to third countries, work with supplying and transit countries on arrangements to handle crisis situations and ensure a stable gas flow to the Union. The Commission should beentitled to deploy a task force to monitor gas flows into the Union in crisis situations after consulting Member States and the third countries involved and, where a crisis arises from difficulties in a third country, to act as mediator and facilitator. The Commission should report regularly to the GCG. (59) Where there is reliable information on a situation outside the Union that threatens the security of gas supply of one or several Member States and that may trigger an early warning mechanism involving the Union and a third country, the Commission should inform the GCG without delay and the Union should take appropriate action to try to defuse the situation. (60) Since the objective of this Regulation, namely to safeguard the security of gas supply in the Union, cannot be sufficiently achieved by Member States acting on their own, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (61) In order to allow for a swift Union response to changing circumstances with regard to the security of gas supply, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the composition of the risk groups as well as templates for the risk assessments and for the preventive action plans and the emergency plans. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (62) Member States' right to determine the conditions for exploiting their energy resources in accordance with Article 194(2) TFEU is not affected by this Regulation. (63) Regulation (EU) No 994/2010 should be repealed. However, in order to avoid legal uncertainty, the preventive action plans and the emergency plans drawn up pursuant to that Regulation should remain in force until the new preventive action plans and emergency plans drawn up pursuant to this Regulation are adopted for the first time, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes provisions aiming to safeguard the security of gas supply in the Union by ensuring the proper and continuous functioning of the internal market in natural gas (\u2018gas\u2019), by allowing for exceptional measures to be implemented when the market can no longer deliver the gas supplies required, including solidarity measure of a last resort, and by providing for the clear definition and attribution of responsibilities among natural gas undertakings, the Member States and the Union regarding both preventive action and the reaction to concrete disruptions of gas supply. This Regulation also establishes transparent mechanisms concerning, in a spirit of solidarity, the coordination of planning for, and response to, emergencies at national, regional and Union level. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018security\u2019 means security as defined in point 32 of Article 2 of Directive 2009/73/EC; (2) \u2018customer\u2019 means customer as defined in point 24 of Article 2 of Directive 2009/73/EC; (3) \u2018household customer\u2019 means household customer as defined in point 25 of Article 2 of Directive 2009/73/EC; (4) \u2018essential social service\u2019 means a service related to healthcare, essential social care, emergency, security, education or public administration; (5) \u2018protected customer\u2019 means a household customer who is connected to a gas distribution network and, in addition, where the Member State concerned so decides, may also mean one or more of the following, provided that enterprises or services as referred to in points (a) and (b) do not, jointly, represent more than 20 % of the total annual final gas consumption in that Member State: (a) a small or medium-sized enterprise, provided that it is connected to a gas distribution network; (b) an essential social service, provided that it is connected to a gas distribution or transmission network; (c) a district heating installation to the extent that it delivers heating to household customers, small or medium-sized enterprises, or essential social services, provided that such installation is not able to switch to other fuels than gas; (6) \u2018solidarity protected customer\u2019 means a household customer who is connected to a gas distribution network, and, in addition, may include one or both of the following: (a) a district heating installation if it is a protected customer in the relevant Member State and only in so far as it delivers heating to households or essential social services other than educational and public administration services; (b) an essential social service if it is a protected customer in the relevant Member State, other than educational and public administration services; (7) \u2018competent authority\u2019 means a national governmental authority or a national regulatory authority designated by a Member State to ensure the implementation of the measures provided for in this Regulation; (8) \u2018national regulatory authority\u2019 means a national regulatory authority designated in accordance with Article 39(1) of Directive 2009/73/EC; (9) \u2018natural gas undertaking\u2019 means natural gas undertaking as defined in point 1 of Article 2 of Directive 2009/73/EC; (10) \u2018gas supply contract\u2019 means gas supply contract as defined in point 34 of Article 2 of Directive 2009/73/EC; (11) \u2018transmission\u2019 means transmission as defined in point 3 of Article 2 of Directive 2009/73/EC; (12) \u2018transmission system operator\u2019 means transmission system operator as defined in point 4 of Article 2 of Directive 2009/73/EC; (13) \u2018distribution\u2019 means distribution as defined in point 5 of Article 2 of Directive 2009/73/EC; (14) \u2018distribution system operator\u2019 means distribution system operator as defined in point 6 of Article 2 of Directive 2009/73/EC; (15) \u2018interconnector\u2019 means interconnector as defined in point 17 of Article 2 of Directive 2009/73/EC; (16) \u2018emergency supply corridors\u2019 means Union gas supply routes that help Member States to better mitigate the effects of potential disruption of supply or infrastructure; (17) \u2018storage capacity\u2019 means storage capacity as defined in point 28 of Article 2 of Regulation (EC) No 715/2009; (18) \u2018technical capacity\u2019 means technical capacity as defined in point 18 of Article 2 of Regulation (EC) No 715/2009; (19) \u2018firm capacity\u2019 means firm capacity as defined in point 16 of Article 2 of Regulation (EC) No 715/2009; (20) \u2018interruptible capacity\u2019 means interruptible capacity as defined in point 13 of Article 2 of Regulation (EC) No 715/2009; (21) \u2018LNG facility capacity\u2019 means LNG facility capacity as defined in point 24 of Article 2 of Regulation (EC) No 715/2009; (22) \u2018LNG facility\u2019 means LNG facility as defined in point 11 of Article 2 of Directive 2009/73/EC; (23) \u2018storage facility\u2019 means storage facility as defined in point 9 of Article 2 of Directive 2009/73/EC; (24) \u2018system\u2019 means system as defined in point 13 of Article 2 of Directive 2009/73/EC; (25) \u2018system user\u2019 means system user as defined in point 23 of Article 2 of Directive 2009/73/EC; (26) \u2018ancillary services\u2019 means ancillary services as defined in point 14 of Article 2 of Directive 2009/73/EC. Article 3 Responsibility for the security of gas supply 1. The security of gas supply shall be the shared responsibility of natural gas undertakings, Member States, in particular through their competent authorities, and the Commission, within their respective areas of activity and competence. 2. Each Member State shall designate a competent authority. The competent authorities shall cooperate with each other in the implementation of this Regulation. Member States may allow the competent authority to delegate specific tasks set out in this Regulation to other bodies. Where competent authorities delegate the task of declaring any of the crisis levels referred to in Article 11(1), they shall do so only to a public authority, a transmission system operator or a distribution system operator. Delegated tasks shall be performed under the supervision of the competent authority and shall be specified in the preventive action plan and in the emergency plan. 3. Each Member State shall, without delay, notify the Commission, and make public, the name of its competent authority and any changes thereto. 4. When implementing the measures provided for in this Regulation, the competent authority shall establish the roles and responsibilities of the different actors concerned in such a way as to ensure a three-level approach which involves, first, the relevant natural gas undertakings, electricity undertakings where appropriate, and industry, second, Member States at national or regional level, and third, the Union. 5. The Commission shall coordinate the action of the competent authorities at regional and Union levels, pursuant to this Regulation, inter alia, through the GCG or, in particular, in the event of a regional or Union emergency pursuant to Article 12(1), through the crisis management group referred to in Article 12(4). 6. In the event of a regional or Union emergency, the transmission system operators shall cooperate and exchange information using the ReCo System for Gas established by ENTSOG. ENTSOG shall inform the Commission and the competent authorities of the Member States concerned accordingly. 7. In accordance with Article 7(2), major transnational risks to the security of gas supply in the Union are to be identified and risk groups are to be established on that basis. Those risk groups shall serve as the basis for enhanced regional cooperation to increase the security of gas supply and shall enable agreement on appropriate and effective cross-border measures of all Member States concerned within the risk groups or outside the risk groups along the emergency supply corridors. The list of such risk groups and their composition are set out in Annex I. The composition of the risk groups shall not prevent any other form of regional cooperation benefiting security of supply. 8. The Commission is empowered to adopt delegated acts in accordance with Article 19 in order to update the composition of the risk groups set out in Annex I by amending that Annex in order to reflect the evolution of the major transnational risks to the security of gas supply in the Union and its impact on Member States, taking into account the result of Union-wide simulation of gas supply and infrastructure disruption scenarios carried out by ENTSOG in accordance with Article 7(1). Before proceeding to the update, the Commission shall consult the GCG in the setting provided for in Article 4(4) on the draft update. Article 4 Gas Coordination Group 1. A Gas Coordination Group (GCG) shall be established to facilitate the coordination of measures concerning the security of gas supply. The GCG shall be composed of representatives of the Member States, in particular representatives of their competent authorities, as well as the Agency for the Cooperation of Energy Regulators (the \u2018Agency\u2019), ENTSOG and representative bodies of the industry concerned and those of relevant customers. The Commission shall, in consultation with the Member States, decide on the composition of the GCG, ensuring it is fully representative. The Commission shall chair the GCG. The GCG shall adopt its rules of procedure. 2. The GCG shall be consulted and shall assist the Commission in particular on the following issues: (a) the security of gas supply, at any time and more specifically in the event of an emergency; (b) all information relevant to the security of gas supply at national, regional and Union level; (c) best practices and possible guidelines to all the parties concerned; (d) the level of the security of gas supply, benchmarks and assessment methodologies; (e) national, regional and Union scenarios and testing the levels of preparedness; (f) the assessment of the preventive action plans and the emergency plans, the coherence across the various plans, and the implementation of the measures provided for therein; (g) the coordination of measures to deal with an Union emergency, with the Energy Community Contracting Parties and with other third countries; (h) assistance needed by the most affected Member States. 3. The Commission shall convene the GCG on a regular basis and shall share the information received from the competent authorities whilst preserving the confidentiality of commercially sensitive information. 4. The Commission may convene the GCG in a setting which is restricted to the representatives of the Member States and in particular of their competent authorities. The Commission shall convene the GCG in this restricted setting if so requested by one or more of the representatives of the Member States and in particular of their competent authorities. In this case, Article 16(2) shall not apply. Article 5 Infrastructure standard 1. Each Member State or, where a Member State so provides, its competent authority shall ensure that the necessary measures are taken so that in the event of a disruption of the single largest gas infrastructure, the technical capacity of the remaining infrastructure, determined in accordance with the N \u2013 1 formula as set out in point 2 of Annex II, is able, without prejudice to paragraph 2 of this Article, to satisfy total gas demand of the calculated area during a day of exceptionally high gas demand occurring with a statistical probability of once in 20 years. This shall be done taking into account gas consumption trends, the long-term impact of energy efficiency measures and the utilisation rates of existing infrastructure. The obligation set out in the first subparagraph of this paragraph shall be without prejudice to the responsibility of the transmission system operators to make the corresponding investments and to the obligations of transmission system operators as laid down in Regulation (EC) No 715/2009 and Directive 2009/73/EC. 2. The obligation to ensure that the remaining infrastructure has the technical capacity to satisfy total gas demand, as referred to in paragraph 1 of this Article, shall also be considered to be fulfilled where the competent authority demonstrates in the preventive action plan that a disruption of gas supply may be sufficiently compensated for, in a timely manner, by appropriate market-based demand-side measures. For that purpose, the N \u2013 1 formula shall be calculated as set out in point 4 of Annex II. 3. Where appropriate, in accordance with the risk assessments referred to in Article 7, the competent authorities of neighbouring Member States may agree to fulfil, jointly, the obligation set out in paragraph 1 of this Article. In such case the competent authorities shall provide in the risk assessment the calculation of the N \u2013 1 formula together with an explanation in the regional chapters of the preventive action plans how the agreed arrangements fulfil that obligation. Point 5 of Annex II shall apply. 4. The transmission system operators shall enable permanent physical capacity to transport gas in both directions (\u2018bi-directional capacity\u2019) on all interconnections between Member States, except: (a) in the case of connections to production facilities, to LNG facilities and to distribution networks; or (b) where an exemption from that obligation has been granted, after detailed assessment and after consulting other Member States and with the Commission in accordance with Annex III. For the procedure to enable or enhance bi-directional capacity on an interconnection or to obtain or prolong an exemption from that obligation Annex III shall apply. The Commission shall make public the list of exemptions and keep it updated. 5. A proposal for enabling or enhancing bi-directional capacity or a request for granting or prolongation of an exemption shall include a cost-benefit analysis prepared on the basis of the methodology pursuant to Article 11 of Regulation (EU) No 347/2013 of the European Parliament and of the Council (14) and shall be based on the following elements: (a) an assessment of market demand; (b) projections for demand and supply; (c) the possible economic impact on existing infrastructure; (d) a feasibility study; (e) the costs of bi-directional capacity including the necessary reinforcement of the transmission system; and (f) the benefits to the security of gas supply taking into account the possible contribution of bi-directional capacity to meeting the infrastructure standard set out in this Article. 6. National regulatory authorities shall take into account the efficiently incurred costs of fulfilling the obligation set out in paragraph 1 of this Article and the costs of enabling bi-directional capacity so as to grant appropriate incentives when fixing or approving, in a transparent and detailed manner, the tariffs or methodologies in accordance with Article 13 of Regulation (EC) No 715/2009 and Article 41(8) of Directive 2009/73/EC. 7. In so far as an investment for enabling or enhancing bi-directional capacity is not required by the market but is considered to be necessary for the security of gas supply purposes and where that investment incurs costs in more than one Member State or in one Member State for the benefit of another Member State, the national regulatory authorities of all Member States concerned shall take a coordinated decision on cost allocation before any investment decision is taken. The cost allocation shall take into account the principles described and the elements contained in Article 12(4) of Regulation (EU) No 347/2013, in particular the proportion of the benefits of the infrastructure investments for the increase of the security of gas supply of the Member States concerned as well as investments already made in the infrastructure in question. The cost allocation shall not unduly distort competition and the effective functioning of the internal market and shall seek to avoid any undue distortive effect on the market. 8. The competent authority shall ensure that any new transmission infrastructure contributes to the security of gas supply through the development of a well-connected network, including, where appropriate, by means of a sufficient number of cross-border entry and exit points relative to market demand and the risks identified. The competent authority shall assess in the risk assessment whether, with an integrated perspective on gas and electricity systems, internal bottlenecks exist and national entry capacity and infrastructure, in particular transmission networks, are capable of adapting the national and cross-border gas flows to the scenario of disruption of the single largest gas infrastructure at national level and the single largest gas infrastructure of common interest to the risk group identified in the risk assessment. 9. By way of exception from paragraph 1 of this Article, and subject to the conditions laid down in this paragraph, Luxembourg, Slovenia and Sweden shall not be bound by, but shall endeavour to meet, the obligation set out in that paragraph, while ensuring the gas supplies to protected customers in accordance with Article 6. The exception shall apply to Luxembourg provided it has: (a) at least two interconnectors with other Member States; (b) at least two different sources of gas supply; and (c) no gas storage facilities on its territory. The exception shall apply to Slovenia provided it has: (a) at least two interconnectors with other Member States; (b) at least two different sources of gas supply; and (c) no gas storage facilities or an LNG facility on its territory. The exception shall apply to Sweden provided it has: (a) no gas transit to other Member States on its territory; (b) an annual gross inland gas consumption of less than 2 Mtoe; and (c) less than 5 % of total primary energy consumption from gas. Luxembourg, Slovenia and Sweden shall inform the Commission of any change affecting the conditions laid down in this paragraph. The exception laid down in this paragraph shall cease to apply where at least one of those conditions is no longer fulfilled. As part of the national risk assessment carried out in accordance with Article 7(3) Luxembourg, Slovenia and Sweden shall describe the situation with respect to the respective conditions laid down in this paragraph and the prospects for compliance with the obligation in paragraph 1 of this Article, taking into account the economic impact of meeting the infrastructure standard, the gas market development and gas infrastructure projects in the risk group. On the basis of the information provided in the national risk assessment and if the respective conditions laid down in this paragraph are still met, the Commission may decide that the exception can continue to apply for four more years. In the event of a positive decision, the procedure set out in this subparagraph shall be repeated after four years. Article 6 Gas supply standard 1. The competent authority shall require the natural gas undertakings that it identifies, to take measures to ensure the gas supply to the protected customers of the Member State in each of the following cases: (a) extreme temperatures during a 7-day peak period occurring with a statistical probability of once in 20 years; (b) any period of 30 days of exceptionally high gas demand, occurring with a statistical probability of once in 20 years; (c) for a period of 30 days in the case of disruption of the single largest gas infrastructure under average winter conditions. By 2 February 2018, each Member State shall notify to the Commission its definition of protected customers, the annual gas consumption volumes of the protected customers and the percentage that those consumption volumes represent of the total annual final gas consumption in that Member State. Where a Member State includes in its definition of protected customers the categories referred to in point (5)(a) or (b) of Article 2, it shall specify the gas consumption volumes corresponding to customers belonging to those categories and the percentage that each of those groups of customers represents in total annual final gas consumption. The competent authority shall identify the natural gas undertakings referred to in the first subparagraph of this paragraph and shall specify them in the preventive action plan. Any new non-market-based measures envisaged to ensure the gas supply standard shall comply with the procedure established in Article 9(4) to (9). Member States may comply with the obligation laid down in the first subparagraph through the implementation of energy efficiency measures or by replacing the gas with a different source of energy, inter alia, renewable energy sources, to the extent that the same level of protection is achieved. 2. Any increased gas supply standard beyond the 30-day period referred to in points (b) and (c) of paragraph 1 or any additional obligation imposed for reasons of security of gas supply shall be based on the risk assessment, shall be reflected in the preventive action plan and shall: (a) comply with Article 8(1); (b) not impact negatively on the ability of any other Member State to supply gas to its protected customers in accordance with this Article in the event of a national, regional or Union emergency; and (c) comply with Article 12(5) in the event of a regional or Union emergency. The Commission may require a justification showing compliance of any measure referred to in the first subparagraph with the conditions laid down therein. Such a justification shall be made public by the competent authority of the Member State that introduces the measure. Any new non-market-based measure pursuant to the first subparagraph of this paragraph, adopted on or after 1 November 2017, shall comply with the procedure established in Article 9(4) to (9). 3. After the expiry of the periods laid down by the competent authority in accordance with paragraphs 1 and 2, or under more severe conditions than those laid down in paragraph 1, the competent authority and natural gas undertakings shall endeavour to maintain, as far as possible, the gas supply, in particular to protected customers. 4. The obligations imposed on natural gas undertakings for the fulfilment of the gas supply standards laid down in this Article shall be non-discriminatory and shall not impose an undue burden on those undertakings. 5. Natural gas undertakings shall be allowed to meet their obligations based on this Article at a regional or Union level, where appropriate. The competent authorities shall not require the gas supply standards laid down in this Article to be met based on infrastructure located only within their territory. 6. The competent authorities shall ensure that conditions for supplies to protected customers are established without prejudice to the proper functioning of the internal energy market and at a price respecting the market value of the supplies. Article 7 Risk assessment 1. By 1 November 2017, ENTSOG shall carry out a Union-wide simulation of gas supply and infrastructure disruption scenarios. The simulation shall include the identification and assessment of emergency gas supply corridors and shall also identify which Member States can address identified risks, including in relation to LNG. The gas supply and infrastructure disruption scenarios and the methodology for the simulation shall be defined by ENTSOG in cooperation with the GCG. ENTSOG shall ensure an appropriate level of transparency and access to the modelling assumptions used in its scenarios. The Union-wide simulation of gas supply and infrastructure disruption scenarios shall be repeated every four years unless circumstances warrant more frequent updates. 2. The competent authorities within each risk group listed in Annex I shall make a common assessment at risk group level (\u2018common risk assessment\u2019) of all relevant risk factors such as natural disasters, technological, commercial, social, political and other risks, which could lead to the materialisation of the major transnational risk to the security of gas supply for which the risk group was created. The competent authorities shall take into account the results of the simulation referred to in paragraph 1 of this Article for the preparation of the risk assessments, preventive action plans and emergency plans. The competent authorities within each risk group shall agree on a cooperation mechanism to conduct the common risk assessment and report it to the GCG eleven months before the deadline for the notification of the common risk assessment and its updates. At the request of a competent authority the Commission may have a facilitating role in the preparation of the common risk assessment, in particular for the establishment of the cooperation mechanism. If competent authorities within a risk group do not agree on a cooperation mechanism, the Commission shall propose a cooperation mechanism for that risk group, after consulting the competent authorities concerned. The competent authorities concerned shall agree on a cooperation mechanism for that risk group taking utmost account of the Commission's proposal. 10 months before the deadline for the notification of the common risk assessment or its updates, each competent authority shall share and update, within the agreed cooperation mechanism, all national data necessary for the preparation of the common risk assessment, in particular for running the various scenarios referred to in point (c) of paragraph 4. 3. The competent authority of each Member State shall make a national risk assessment (\u2018national risk assessment\u2019) of all relevant risks affecting the security of gas supply. Such assessment shall be fully consistent with the assumptions and results of the common risk assessment(s). 4. The risk assessments referred to in paragraphs 2 and 3 of this Article shall be carried out, as relevant, by: (a) using the standards specified in Articles 5 and 6. The risk assessment shall describe the calculation of the N \u2013 1 formula at national level and where appropriate include a calculation of the N \u2013 1 formula at regional level. The risk assessment shall also include the assumptions used, including where applicable those for the calculation of the N \u2013 1 formula at regional level, and the data necessary for such calculation. The calculation of the N \u2013 1 formula at national level shall be accompanied by a simulation of disruption of the single largest gas infrastructure using hydraulic modelling for the national territory as well as by a calculation of the N \u2013 1 formula considering the level of gas in storages at 30 % and 100 % of the maximum working volume; (b) taking into account all relevant national and transnational circumstances, in particular market size, network configuration, actual flows, including outflows from the Member States concerned, the possibility of physical gas flows in both directions including the potential need for consequent reinforcement of the transmission system, the presence of production and storage and the role of gas in the energy mixes, in particular with respect to district heating and electricity generation and for the operation of industries, and safety and gas quality considerations; (c) running various scenarios of exceptionally high demand for gas and disruption of gas supply, taking into account the history, probability, season, frequency and duration of their occurrence and assessing their likely consequences, such as: (i) disruption of the infrastructure relevant to the security of gas supply, in particular transmission infrastructure, storages or LNG terminals, including the largest gas infrastructure identified for the calculation of N \u2013 1 formula; and (ii) disruption of supplies from third-country suppliers, as well as, where appropriate, geopolitical risks; (d) identifying the interaction and correlation of risks among the Member States in the risk group and with other Member States or other risk groups, as appropriate, including, as regards interconnections, cross-border supplies, cross-border access to storage facilities and bi-directional capacity; (e) taking into account risks relating to the control of infrastructure relevant to the security of gas supply to the extent that they may involve, inter alia, risks of underinvestment, undermining diversification, misuse of existing infrastructure or an infringement of Union law; (f) taking into account the maximal interconnection capacity of each border entry and exit point and various filling levels for storage. 5. The common and national risk assessments shall be prepared in accordance with the relevant template set out in Annex IV or V. If necessary, Member States may include additional information. The Commission is empowered to adopt delegated acts in accordance with Article 19 in order to amend the templates set out in Annexes IV and V, after consulting the GCG, in order to reflect the experience gained in the application of this Regulation, and to reduce the administrative burden on Member States. 6. Natural gas undertakings, industrial gas customers, the relevant organisations representing the interests of household and industrial gas customers as well as Member States and, where they are not the competent authorities, the national regulatory authorities, shall cooperate with the competent authorities and provide them upon request with all necessary information for the common and national risk assessments. 7. By 1 October 2018 Member States shall notify to the Commission the first common risk assessment once agreed by all Member States in the risk group and the national risk assessments. The risk assessments shall be updated every four years thereafter unless circumstances warrant more frequent updates. The risk assessments shall take account of progress made in investments needed to cope with the infrastructure standard defined in Article 5 and of country-specific difficulties encountered in the implementation of new alternative solutions. They shall also build on the experience acquired through the simulation of the emergency plans contained in Article 10(3). Article 8 Establishment of preventive action plans and emergency plans 1. The measures to ensure the security of gas supply contained in a preventive action plan and an emergency plan shall be clearly defined, transparent, proportionate, non-discriminatory and verifiable, shall not unduly distort competition or the effective functioning of the internal market in gas and shall not endanger the security of gas supply of other Member States or of the Union. 2. The competent authority of each Member State shall, after consulting the natural gas undertakings, the relevant organisations representing the interests of household and industrial gas customers, including electricity producers, electricity transmission system operators, and, where it is not the competent authority, the national regulatory authority, establish: (a) a preventive action plan containing the measures needed to remove or mitigate the risks identified, including the effects of energy efficiency and demand-side measures in the common and nationals risk assessments and in accordance with Article 9; (b) an emergency plan containing the measures to be taken to remove or mitigate the impact of a disruption of gas supply in accordance with Article 10. 3. The preventive action plan and the emergency plan shall contain a regional chapter, or several regional chapters, where a Member State is a member of different risk groups as defined in Annex I. The regional chapters shall be developed jointly by all Member States in the risk group before incorporation in the respective national plans. The Commission shall act as a facilitator so as to enable that the regional chapters collectively enhance the security of gas supply in the Union, and, do not give rise to any contradiction, and to overcome any obstacles to cooperation. The regional chapters shall contain appropriate and effective cross-border measures, including in relation to LNG, subject to agreement between the Member States implementing the measures from the same or different risk groups affected by the measure on the basis of the simulation referred to in Article 7(1) and the common risk assessment. 4. The competent authorities shall report regularly to the GCG on the progress achieved on the preparation and adoption of the preventive action plans and the emergency plans, in particular the regional chapters. In particular, competent authorities shall agree on a cooperation mechanism for the preparation of the preventive action plan and the emergency plan, including the exchange of draft plans. They shall report to the GCG on such agreed cooperation mechanism 16 months before the deadline for agreement of those plans and the updates of those plans. The Commission may have a facilitating role in the preparation of the preventive action plan and the emergency plan, in particular for the establishment of the cooperation mechanism. If competent authorities within a risk group do not agree on a cooperation mechanism, the Commission shall propose a cooperation mechanism for that risk group. The competent authorities concerned shall agree on the cooperation mechanism for that risk group taking account of the Commission's proposal. The competent authorities shall ensure the regular monitoring of the implementation of the preventive action plan and the emergency plan. 5. The preventive action plan and the emergency plan shall be developed in accordance with the templates contained in Annexes VI and VII. The Commission is empowered to adopt delegated acts in accordance with Article 19 in order to amend the templates set out in Annexes VI and VII, after consulting the GCG, in order to reflect the experience gained in the application of this Regulation, and to reduce the administrative burden on Member States. 6. The competent authorities of neighbouring Member States shall in due time consult each other with a view to ensuring consistency between their preventive action plans and their emergency plans. The competent authorities shall, within each risk group, exchange draft preventive action plans and emergency plans with proposals for cooperation, at the latest five months before the deadline for submission of the plans. The final versions of the regional chapters referred to in paragraph 3 shall be agreed by all Member States in the risk group. The preventive action plans and emergency plans shall also contain the national measures necessary to implement and enforce the cross-border measures in the regional chapters. 7. The preventive action plans and the emergency plans shall be made public and notified to the Commission by 1 March 2019. The Commission shall inform the GCG about the notification of the plans and publish them on the Commission's website. Within four months of the notification by the competent authorities, the Commission shall assess the plans taking into account the views expressed in the GCG. 8. The Commission shall issue an opinion to the competent authority with the recommendation to review a preventive action plan or an emergency plan if one or more of the following applies: (a) it is not effective to mitigate the risks as identified in the risk assessment; (b) it is inconsistent with the risk scenarios assessed or with the plans of another Member State or a risk group; (c) it does not comply with the requirement laid down in paragraph 1 not unduly to distort competition or the effective functioning of the internal market; (d) it does not comply with the provisions of this Regulation or other provisions of Union law. 9. Within three months of notification of the Commission's opinion referred to in paragraph 8, the competent authority concerned shall notify the amended preventive action plan or the emergency plan to the Commission, or shall inform the Commission of the reasons for which it disagree with the recommendations. In the event of disagreement related to elements referred to in paragraph 8, the Commission may, within four months of the reply of the competent authority, withdraw its request or convene the competent authority and, where the Commission considers it to be necessary, the GCG, in order to consider the issue. The Commission shall set out its detailed reasons for requesting any amendments to the preventive action plan or the emergency plan. The competent authority concerned shall take full account of the detailed reasons of the Commission. Where applicable, the competent authority concerned shall without delay amend and make the amended preventive action plan or emergency plan public. Where the final position of the competent authority concerned diverges from the Commission's detailed reasons, that competent authority shall provide and make public, together with its position and the Commission's detailed reasons, the justification underlying its position within two months of receipt of the detailed reasons of the Commission. 10. For non-market-based measures adopted on or after 1 November 2017, the procedure set out in Article 9(4), (6), (8) and (9) shall apply. 11. The confidentiality of commercially sensitive information shall be preserved. 12. Preventive action plans and emergency plans developed under Regulation (EU) No 994/2010, updated in accordance with that Regulation, shall remain in force until the preventive action plans and the emergency plans referred to in paragraph 1 of this Article are established for the first time. Article 9 Content of preventive action plans 1. The preventive action plan shall contain: (a) the results of the risk assessment and a summary of the scenarios considered, as referred to in point (c) of Article 7(4); (b) the definition of protected customers and the information described in the second subparagraph of Article 6(1); (c) the measures, volumes and capacities needed to fulfil the infrastructure and gas supply standards laid down in Articles 5 and 6, including, where applicable, the extent to which demand-side measures can sufficiently compensate, in a timely manner, for a disruption of gas supply as referred to in Article 5(2), the identification of the single largest gas infrastructure of common interest in the case of the application of Article 5(3), the necessary gas volumes per category of protected customers and per scenario as referred to in Article 6(1), and any increased gas supply standard including any justification showing compliance with the conditions laid down in Article 6(2) and a description of a mechanism to reduce temporarily any increased gas supply standard or additional obligation in accordance with Article 11(3); (d) obligations imposed on natural gas undertakings, electricity undertakings where appropriate, and other relevant bodies likely to have an impact on the security of gas supply, such as obligations for the safe operation of the gas system; (e) other preventive measures designed to address the risks identified in the risk assessment, such as those relating to the need to enhance interconnections between neighbouring Member States, to further improve energy efficiency, to reduce gas demand and the possibility to diversify gas routes and sources of gas supply and the regional utilisation of existing storage and LNG capacities, if appropriate, in order to maintain gas supply to all customers as far as possible; (f) information on the economic impact, effectiveness and efficiency of the measures contained in the plan, including the obligations referred to in point (k); (g) a description of the effects of the measures contained in the plan on the functioning of the internal energy market as well as national markets, including the obligations referred to in point (k); (h) a description of the impact of the measures on the environment and on customers; (i) the mechanisms to be used for cooperation with other Member States, including the mechanisms for preparing and implementing preventive action plans and emergency plans; (j) information on existing and future interconnections and infrastructure, including those providing access to the internal market, cross-border flows, cross-border access to storage and LNG facilities and the bi-directional capacity, in particular in the event of an emergency; (k) information on all public service obligations that relate to the security of gas supply. Critical information relating to points (a), (c) and (d) of the first subparagraph which, if revealed, could endanger the security of gas supply, may be excluded. 2. The preventive action plan, in particular the actions to meet the infrastructure standard as laid down in Article 5, shall take into account the Union-wide TYNDP elaborated by ENTSOG pursuant to Article 8(10) of Regulation (EC) No 715/2009. 3. The preventive action plan shall be based primarily on market-based measures and shall not put an undue burden on natural gas undertakings, or negatively impact on the functioning of the internal market in gas. 4. Member States, and in particular their competent authorities, shall ensure that all preventive non-market-based measures, such as those referred to in Annex VIII, adopted on or after 1 November 2017, irrespective of whether they are part of the preventive action plan or adopted subsequently, comply with the criteria laid down in the first subparagraph of Article 6(2). 5. The competent authority shall make public any measure referred to in paragraph 4 which has not yet been included in the preventive action plan, and shall notify to the Commission the description of any such measure and of its impact on the national gas market and, to the extent possible, on the gas markets of other Member States. 6. If the Commission doubts whether a measure referred to in paragraph 4 of this Article complies with the criteria laid down in the first subparagraph of Article 6(2) it shall request from the Member State concerned the notification of an impact assessment. 7. An impact assessment pursuant to paragraph 6 shall cover at least the following: (a) the potential impact on the development of the national gas market and competition at national level; (b) the potential impact on the internal gas market; (c) the potential impact on the security of gas supply of neighbouring Member States, in particular for those measures that could reduce the liquidity in regional markets or restrict flows to neighbouring Member States; (d) the costs and benefits, assessed against alternative market-based-measures; (e) an assessment of necessity and proportionality in comparison with possible market-based measures; (f) an appreciation whether the measure ensures equal possibilities for all market participants; (g) a phase-out strategy, the expected duration of the envisaged measure and an appropriate review calendar. The analysis referred to in points (a) and (b) shall be carried out by the national regulatory authority. The impact assessment shall be made public by the competent authority and shall be notified to the Commission. 8. Where the Commission considers, based on the impact assessment, that the measure is likely to endanger the security of gas supply of other Member States or of the Union it shall take a decision within four months of notification of the impact assessment requiring, to the extent necessary, the amendment or withdrawal of the measure. The adopted measure shall enter into force only when it is approved by the Commission or has been amended in accordance with the Commission decision. The four-month period shall begin on the day following receipt of a complete notification. The four-month period may be extended with the consent of both the Commission and the competent authority. 9. Where the Commission considers, based on the impact assessment, that the measure does not comply with the criteria laid down in the first paragraph of Article 6(2) it may issue an opinion within four months of notification of the impact assessment. The procedure set out in Article 8(8) and (9) shall apply. The four-month period shall begin on the day following receipt of a complete notification. The four-month period may be extended with the consent of both the Commission and the competent authority. 10. Article 8(9) shall apply to any measure subject to paragraphs 6 to 9 of this Article. 11. The preventive action plan shall be updated every four years after 1 March 2019 or more frequently if the circumstances so warrant or at the Commission's request. The updated plan shall reflect the updated risk assessment and the results of the tests carried out in accordance with Article 10(3). Article 8 shall apply to the updated plan. Article 10 Content of emergency plans 1. The emergency plan shall: (a) build upon the crisis levels referred to in Article 11(1); (b) define the role and responsibilities of natural gas undertakings, transmission system operators for electricity if relevant and of industrial gas customers including relevant electricity producers, taking account of the different extent to which they are affected in the event of a disruption of gas supply, and their interaction with the competent authorities and where appropriate with the national regulatory authorities at each of the crisis levels referred to in Article 11(1); (c) define the role and responsibilities of the competent authorities and of the other bodies to which tasks have been delegated as referred to in Article 3(2) at each of the crisis levels referred to in Article 11(1); (d) ensure that natural gas undertakings and industrial gas customers including relevant electricity producers are given sufficient opportunity to respond to the crisis levels referred to in Article 11(1); (e) identify, if appropriate, the measures and actions to be taken to mitigate the potential impact of a disruption of gas supply on district heating and the supply of electricity generated from gas, including through an integrated view of energy systems operations across electricity and gas if relevant; (f) establish detailed procedures and measures to be followed for the crisis levels referred to in Article 11(1), including the corresponding schemes on information flows; (g) designate a crisis manager and define its role; (h) identify the contribution of market-based measures for coping with the situation at alert level and mitigating the situation at emergency level; (i) identify the contribution of non-market-based measures planned or to be implemented for the emergency level, and assess the degree to which the use of such non-market-based measures is necessary to cope with a crisis. The effects of the non-market-based measures shall be assessed and procedures for their implementation defined. Non-market-based measures are to be used only when market-based mechanisms alone can no longer ensure supplies, in particular to protected customers, or for the application of Article 13; (j) describe the mechanisms used to cooperate with other Member States for the crisis levels referred to in Article 11(1) and information exchange arrangements between the competent authorities; (k) detail the reporting obligations imposed on natural gas undertakings and, where appropriate, electricity undertakings at alert and emergency levels; (l) describe the technical or legal arrangements in place to prevent undue gas consumption of customers who are connected to a gas distribution or transmission network but not protected customers; (m) describe the technical, legal and financial arrangements in place to apply the solidarity obligations laid down in Article 13; (n) estimate the gas volumes that could be consumed by solidarity protected customers covering at least the cases described in Article 6(1); (o) establish a list of predefined actions to make gas available in the event of an emergency, including commercial agreements between the parties involved in such actions and the compensation mechanisms for natural gas undertakings where appropriate, taking due account of the confidentiality of sensitive data. Such actions may involve cross-border agreements between Member States and/or natural gas undertakings. In order to prevent undue gas consumption during an emergency, as referred to in point (l) of the first subparagraph, or during the application of the measures referred to in Article 11(3) and Article 13, the competent authority of the Member State concerned shall inform customers who are not protected customers that they are required to cease or reduce their gas consumption without creating technically unsafe situations. 2. The emergency plan shall be updated every four years after 1 March 2019 or more frequently if circumstances so warrant or at the Commission's request. The updated plan shall reflect the updated risk assessment and the results of the tests carried out in accordance with paragraph 3 of this Article. Article 8(4) to (11) shall apply to the updated plan. 3. The measures, actions and procedures contained in the emergency plan shall be tested at least once between its four-year updates referred to in paragraph 2. In order to test the emergency plan, the competent authority shall simulate high and medium impact scenarios and responses in real time in accordance with that emergency plan. The results of the tests shall be presented at the GCG by the competent authority. 4. The emergency plan shall ensure that cross-border access to infrastructure in accordance with Regulation (EC) No 715/2009 is maintained as far as technically and safely possible in the event of an emergency and shall not introduce any measure unduly restricting the flow of gas across borders. Article 11 Declaration of a crisis 1. There shall be the following three crisis levels: (a) early warning level (\u2018early warning\u2019): where there is concrete, serious and reliable information that an event which is likely to result in significant deterioration of the gas supply situation may occur and is likely to lead to the alert or the emergency level being triggered; the early warning level may be activated by an early warning mechanism; (b) alert level (\u2018alert\u2019): where a disruption of gas supply or exceptionally high gas demand which results in significant deterioration of the gas supply situation occurs but the market is still able to manage that disruption or demand without the need to resort to non-market-based measures; (c) emergency level (\u2018emergency\u2019): where there is exceptionally high gas demand, significant disruption of gas supply or other significant deterioration of the gas supply situation and all relevant market-based measures have been implemented but the gas supply is insufficient to meet the remaining gas demand so that non-market-based measures have to be additionally introduced with a view, in particular, to safeguarding gas supplies to protected customers in accordance with Article 6. 2. When the competent authority declares one of the crisis levels referred to in paragraph 1, it shall immediately inform the Commission as well as the competent authorities of the Member States with which the Member State of that competent authority is directly connected and provide them with all the necessary information, in particular with information on the action it intends to take. In the event of an emergency which may result in a call for assistance from the Union and its Member States, the competent authority of the Member State concerned shall without delay notify the Commission's Emergency Response Coordination Centre (ERCC). 3. Where a Member State has declared an emergency and has indicated that cross-border action is required, any increased gas supply standard or additional obligation under Article 6(2) imposed on natural gas undertakings in other Member States in the same risk group shall be temporarily reduced to the level established in Article 6(1). The obligations laid down in the first subparagraph of this paragraph shall cease to apply immediately after the competent authority declares an end to an emergency, or the Commission concludes, in accordance with the first subparagraph of paragraph 8, that the declaration of an emergency is not or is no longer justified. 4. When the competent authority declares an emergency it shall follow the pre-defined action as set out in its emergency plan and shall immediately inform the Commission and the competent authorities in the risk group as well as the competent authorities of the Member States with which the Member State of that competent authority is directly connected in particular of the action it intends to take. In duly justified exceptional circumstances, the competent authority may take action deviating from the emergency plan. The competent authority shall immediately inform the Commission and the competent authorities in its risk group as set out in Annex I, as well as the competent authorities of the Member States with which the Member State of that competent authority is directly connected, of any such action and shall provide a justification for the deviation. 5. The transmission system operator shall ensure that when an emergency is declared in a neighbouring Member State, capacity at interconnection points to that Member State, irrespective of whether firm or interruptible, and whether it has been booked before or during the emergency, has priority over competing capacity at exit points into storage facilities. The system user of the prioritised capacity shall promptly pay fair compensation to the system user of the firm capacity for the financial loss incurred as a result of prioritisation including a proportionate reimbursement for the cost of the firm capacity being interrupted. The process of determining and paying the compensation shall not affect the implementation of the priority rule. 6. The Member States and, in particular, the competent authorities shall ensure that: (a) no measures are introduced which unduly restrict the flow of gas within the internal market at any time; (b) no measures are introduced that are likely seriously to endanger the gas supply situation in another Member State; and (c) cross-border access to infrastructure in accordance with Regulation (EC) No 715/2009 is maintained as far as technically and safely possible, in accordance with the emergency plan. 7. During an emergency and on reasonable grounds, upon a request of the relevant electricity or gas transmission system operator a Member State may decide to prioritise the gas supply to certain critical gas-fired power plants over the gas supply to certain categories of protected customers, if the lack of gas supply to such critical gas-fired power plants either: (a) could result in severe damage in the functioning of the electricity system; or (b) would hamper the production and/or transportation of gas. Member States shall base any such measure on the risk assessment. Critical gas-fired power plants as referred to in the first subparagraph shall be clearly identified together with the possible gas volumes that would be subject to such a measure and included in the regional chapters of the preventive action plans and emergency plans. Their identification shall be carried out in close cooperation with transmission system operators of the electricity system and the gas system of the Member State concerned. 8. The Commission shall verify, as soon as possible, but in any case within five days of receiving the information referred to in paragraph 2 from the competent authority, whether the declaration of an emergency is justified in accordance with point (c) of paragraph 1 and whether the measures taken follow as closely as possible the actions listed in the emergency plan and are not imposing an undue burden on natural gas undertakings and are in accordance with paragraph 6. The Commission may, at the request of another competent authority, natural gas undertakings or on its own initiative, request the competent authority to modify the measures where they are contrary to the conditions referred to in the first sentence of this paragraph. The Commission may also request the competent authority to declare an end to the emergency where it concludes that the declaration of an emergency is not or is no longer justified in accordance with point (c) of paragraph 1. Within three days of notification of the Commission request, the competent authority shall modify the measures and shall notify the Commission thereof, or shall inform the Commission of the reasons for which it disagrees with the request. In the latter case, the Commission may, within three days of being informed, amend or withdraw its request or, in order to consider the issue, convene the competent authority or, where appropriate, the competent authorities concerned, and, where the Commission considers it to be necessary, the GCG. The Commission shall set out its detailed reasons for requesting any modification to the action. The competent authority shall take full account of the position of the Commission. Where the final decision of the competent authority diverges from the Commission position, the competent authority shall provide the reasons underlying such decision. 9. When the competent authority declares an end to one of the crisis levels referred to in paragraph 1, it shall inform the Commission as well as the competent authorities of the Member States with which the Member State of that competent authority is directly connected. Article 12 Regional and Union emergency responses 1. The Commission may declare a regional or Union emergency at the request of a competent authority that has declared an emergency and following the verification in accordance with Article 11(8). The Commission shall declare, as appropriate, a regional or Union emergency at the request of at least two competent authorities that have declared an emergency and following the verification in accordance with Article 11(8), and where the reasons for such emergencies are linked. In all cases, when it declares a regional or Union emergency, the Commission, using the means of communication most appropriate to the situation, shall gather the views of, and take due account of all the relevant information provided by other competent authorities. When the Commission decides, following an assessment, that the underlying basis for the regional or Union emergency no longer justifies the declaration of an emergency, it shall declare an end to the regional or Union emergency and shall give its reasons and inform the Council of its decision. 2. The Commission shall convene the GCG as soon as it declares a regional or Union emergency. 3. In a regional or Union emergency, the Commission shall coordinate the action of the competent authorities, taking full account of relevant information from, and the results of, the consultation of the GCG. In particular, the Commission shall: (a) ensure the exchange of information; (b) ensure the consistency and effectiveness of action at Member State and regional levels in relation to the Union level; (c) coordinate the actions with regard to third countries. 4. The Commission may convene a crisis management group composed of the crisis managers referred to in point (g) of Article 10(1), of the Member States concerned by the emergency. The Commission, in agreement with the crisis managers, may invite other relevant stakeholders to participate. The Commission shall ensure that the GCG is informed regularly about the work undertaken by the crisis management group. 5. The Member States and in particular the competent authorities shall ensure that: (a) no measures are introduced which unduly restrict the flow of gas within the internal market at any time, in particular the flow of gas to the affected markets; (b) no measures are introduced that are likely seriously to endanger the gas supply situation in another Member State; and (c) cross-border access to infrastructure in accordance with Regulation (EC) No 715/2009 is maintained as far as technically and safely possible, in accordance with the emergency plan. 6. Where, at the request of a competent authority or a natural gas undertaking or on its own initiative, the Commission considers that, in a regional or Union emergency, action taken by a Member State or a competent authority or the behaviour of a natural gas undertaking is contrary to paragraph 5, the Commission shall request that Member State or competent authority to modify its action or to take action in order to ensure compliance with paragraph 5, informing it of the reasons therefor. Due account shall be taken of the need to operate the gas system safely at all times. Within three days of notification of the Commission request, the Member State or the competent authority shall modify its action and notify the Commission thereof, or shall inform the Commission of the reasons for which it disagrees with the request. In the latter case, the Commission may, within three days of being informed, amend or withdraw its request or convene the Member State or the competent authority and, where the Commission considers it to be necessary, the GCG in order to consider the issue. The Commission shall set out its detailed reasons for requesting any modification to the action. The Member State or the competent authority shall take full account of the position of the Commission. Where the final decision of the competent authority or the Member State diverges from the Commission position, the competent authority or the Member State shall provide the reasons underlying such decision. 7. The Commission, after consulting the GCG, shall establish a permanent reserve list for a monitoring task force consisting of industry experts and representatives of the Commission. The monitoring task force may be deployed outside the Union when necessary and shall monitor and report on the gas flows into the Union, in cooperation with the supplying and transiting third countries. 8. The competent authority shall provide to the Commission's ERCC the information on any need for assistance. ERCC shall assess the overall situation and advise on the assistance that should be provided to the most affected Member States, and where appropriate to third countries. Article 13 Solidarity 1. If a Member State has requested the application of the solidarity measure pursuant to this Article, a Member State which is directly connected to the requesting Member State or, where the Member State so provides, its competent authority or transmission system operator or distribution system operator shall as far as possible without creating unsafe situations, take the necessary measures to ensure that the gas supply to customers other than solidarity protected customers in its territory is reduced or does not continue to the extent necessary and for as long as the gas supply to solidarity protected customers in the requesting Member State is not satisfied. The requesting Member State shall ensure that the relevant volume of gas is effectively delivered to solidarity protected customers in its territory. In exceptional circumstances and upon a duly reasoned request by the relevant electricity or gas transmission system operator to its competent authority, the gas supply may also continue to certain critical gas-fired power plants as defined pursuant to Article 11(7) in the Member State providing solidarity if the lack of gas supply to such plants would result in severe damage in the functioning of the electricity system or would hamper the production and/or transportation of gas. 2. A Member State shall also provide the solidarity measure to another Member State to which it is connected via a third country unless flows are restricted through the third country. Such an extension of the measure shall be subject to the agreement of the relevant Member States, who shall involve, as appropriate, the third country through which they are connected. 3. A solidarity measure shall be taken as a last resort and shall apply only if the requesting Member State has: (a) not been able to cover the deficit in gas supply to its solidarity protected customers despite the application of the measure referred to in Article 11(3); (b) exhausted all market-based measures and all measures provided in its emergency plan; (c) notified an explicit request to the Commission and to the competent authorities of all Member States with which it is connected either directly or pursuant to paragraph 2 via a third country, accompanied by a description of the implemented measures referred to in point (b) of this paragraph; (d) undertaken to pay fair and prompt compensation to the Member State providing solidarity in accordance with paragraph 8. 4. If there is more than one Member State that could provide solidarity to a requesting Member State, the requesting Member State shall, after consulting all Member States required to provide solidarity, seek the most advantageous offer on the basis of cost, speed of delivery, reliability and diversification of supplies of gas. The Member States concerned shall make such offers on the basis of voluntary demand-side measures as much as and for as long as possible, before resorting to non-market-based measures. 5. Where market-based measures prove insufficient for the Member State providing solidarity to address the deficit in gas supply to solidarity protected customers in the requesting Member State, the Member State providing solidarity may introduce non-market-based measures in order to comply with the obligations laid down in paragraphs 1 and 2. 6. The competent authority of the requesting Member State shall immediately inform the Commission and the competent authorities of the Member States providing solidarity when gas supply to solidarity protected customers in its territory is satisfied or where the obligations under paragraphs 1 and 2 are, based on its needs, reduced, or where they are suspended at the request of the Member State receiving solidarity. 7. The obligations laid down in paragraphs 1 and 2 shall apply subject to the technically safe and reliable operation of the gas system of a Member State providing solidarity and the limit of the maximum interconnection export capability of the relevant Member State infrastructure towards the requesting Member State. Technical, legal and financial arrangements may reflect such circumstances in particular those under which the market will deliver up to maximum interconnection capacity. 8. Solidarity under this Regulation shall be provided on the basis of compensation. The Member State requesting solidarity shall promptly pay, or ensure prompt payment of, fair compensation to the Member State providing solidarity. Such fair compensation shall cover at least: (a) the gas delivered into the territory of the requesting Member State; (b) all other relevant and reasonable costs incurred when providing solidarity, including, where appropriate, costs of such measures that may have been established in advance; (c) reimbursement for any compensation resulting from judicial proceedings, arbitration proceedings or similar proceedings and settlements and related costs of such proceedings involving the Member State providing solidarity vis-a-vis entities involved in the provision of such solidarity. Fair compensation pursuant to the first subparagraph shall include, inter alia, all reasonable costs that the Member State providing solidarity incurs from an obligation to pay compensation by virtue of fundamental rights guaranteed by Union law and by virtue of the applicable international obligations when implementing this Article and further reasonable costs incurred from payment of compensation pursuant to national compensation rules. By 1 December 2018, the Member States shall adopt the necessary measures, in particular the technical, legal and financial arrangements pursuant to paragraph 10, to implement the first and second subparagraphs of this paragraph. Such measures may provide for the practical modalities of prompt payment. 9. Member States shall ensure that the provisions of this Article are implemented in conformity with the Treaties, the Charter of Fundamental Rights of the European Union, as well as the applicable international obligations. They shall take the necessary measures to that effect. 10. By 1 December 2018, the Member States shall adopt the necessary measures, including those agreed in technical, legal and financial arrangements, to ensure that gas is supplied to solidarity protected customers in the requesting Member State in accordance with paragraphs 1 and 2. The technical, legal and financial arrangements shall be agreed among the Member States which are directly connected or, in accordance with paragraph 2, via a third country, and shall be described in their respective emergency plans. Such arrangements may cover, among others, the following elements: (a) the operational safety of networks; (b) gas prices to be applied and/or the methodology for their setting, taking into account the impact on the functioning of the market; (c) the use of interconnections, including bi-directional capacity and underground gas storage; (d) gas volumes or the methodology for their setting; (e) categories of costs that will have to be covered by a fair and prompt compensation, that may include damages for curtailed industry; (f) an indication of the method how the fair compensation could be calculated. The financial arrangement agreed between Member States before solidarity is requested shall contain provisions that allow for the calculation of the fair compensation of at least all relevant and reasonable costs incurred when providing solidarity and an undertaking that such compensation will be paid. Any compensation mechanism shall provide incentives to participate in market-based solutions such as auctions and demand response mechanisms. It shall not create perverse incentives, including in financial terms, for market players to postpone their action until non-market-based measures are applied. All compensation mechanisms or at least their summary shall be included in the emergency plans. 11. For as long as a Member State can cover the gas consumption for its solidarity protected customers from its own production, it shall be exempt from the obligation to conclude technical, legal and financial arrangements with Member States with which it is directly connected or, in accordance with paragraph 2, via a third country, for the purpose of receiving solidarity. Such an exemption shall not affect the obligation of the relevant Member State to provide solidarity to other Member States pursuant to this Article. 12. By 1 December 2017 and after consulting the GCG, the Commission shall provide for legally non-binding guidance for the key elements of the technical, legal and financial arrangements especially on how to apply the elements described in paragraphs 8 and 10 in practice. 13. Where Member States do not agree on the necessary technical, legal and financial arrangements by 1 October 2018, the Commission may after consulting the competent authorities concerned, propose a framework for such measures setting out the necessary principles to make them operational which shall build on the Commission's guidance set out in paragraph 12. Member States shall finalise their arrangements by 1 December 2018 taking utmost account of the Commission's proposal. 14. The applicability of this Article shall not be affected if Member States fail to agree or finalise their technical, legal and financial arrangements. In such a situation the Member States concerned shall agree on the necessary ad hoc measures and the Member State requesting solidarity shall provide an undertaking in accordance with point (d) of paragraph 3. 15. The obligations laid down in paragraphs 1 and 2 of this Article shall cease to apply immediately after the declaration of the end of an emergency or the Commission concludes, in accordance with the first subparagraph of Article 11(8), that the declaration of an emergency is not or is no longer justified. 16. Where the Union incurs costs by virtue of any liability, other than for unlawful acts or conduct pursuant to the second paragraph of Article 340 TFEU, in respect of measures that Member States are required to take pursuant to this Article, those costs shall be reimbursed to it by the Member State receiving solidarity. Article 14 Information exchange 1. Where a Member State has declared one of the crisis levels referred to in Article 11(1), the natural gas undertakings concerned shall make available, on a daily basis, in particular the following information to the competent authority of the Member State concerned: (a) the daily gas demand and gas supply forecasts for the following three days, in million cubic metres per day (mcm/d); (b) the daily flow of gas at all cross-border entry and exit points as well as at all points connecting a production facility, a storage facility or an LNG terminal to the network, in million cubic metres per day (mcm/d); (c) the period, expressed in days, for which it is expected that supply of gas to protected customers can be ensured. 2. In the event of a regional or Union emergency, the Commission may request that the competent authority referred to in paragraph 1 provide it without delay with at least: (a) the information set out in paragraph 1; (b) information on the measures planned to be undertaken and those already implemented by the competent authority to mitigate the emergency, and information on their effectiveness; (c) the requests made for additional measures to be taken by other competent authorities; (d) the measures implemented at the request of other competent authorities. 3. After an emergency, the competent authority referred to in paragraph 1 shall, as soon as possible and at the latest six weeks after the lifting of the emergency, provide the Commission with a detailed assessment of the emergency and the effectiveness of the measures implemented, including an assessment of the economic impact of the emergency, the impact on the electricity sector and the assistance provided to or received from, the Union and its Member States. Such assessment shall be made available to the GCG and shall be reflected in the updates of the preventive action plans and the emergency plans. The Commission shall analyse the assessments of the competent authorities and shall inform the Member States, the European Parliament and the GCG of the results of its analysis in an aggregated form. 4. In duly justified circumstances irrespective of a declaration of an emergency, the competent authority of the most affected Member State may require natural gas undertakings to provide the information referred to in paragraph 1 or additional information necessary to assess the overall situation of the gas supply in the Member State or other Member States, including contractual information, other than price information. The Commission may request from the competent authorities the information provided by natural gas undertakings under this paragraph, provided that the same information has not been transmitted already to the Commission. 5. Where the Commission considers the gas supply in the Union or part of the Union to be at risk or is likely to be at risk that may lead to the declaration of one of the crisis levels referred to in Article 11(1), it may require the competent authorities concerned to collect and submit to the Commission information necessary to assess of the gas supply situation. The Commission shall share its assessment with the GCG. 6. In order for the competent authorities and the Commission to assess the security of gas supply situation at national, regional and Union level, each natural gas undertaking shall notify: (a) to the competent authority concerned the following details of gas supply contracts with a cross-border dimension and a duration of more than one year which it has concluded to procure gas: (i) contract duration; (ii) yearly contracted volumes; (iii) contracted maximum daily volumes in the event of an alert or emergency; (iv) contracted delivery points; (v) minimum daily and monthly gas volumes; (vi) conditions for the suspension of gas deliveries. (vii) an indication whether the contract individually or cumulatively with its contracts with the same supplier or its affiliates is equivalent to or exceeds the threshold of 28 % as referred to in point (b) of paragraph 6 in the most affected Member State. (b) to the competent authority of the most affected Member State immediately after their conclusion or modification its gas supply contracts with a duration of more than one year, concluded or modified on or after 1 November 2017 that individually or cumulatively with its contracts with the same supplier or its affiliates is equivalent to 28 % or more of yearly gas consumption in that Member State to be calculated on the basis of the most recent available data. In addition, by 2 November 2018 natural gas undertakings shall notify the competent authority of all existing contracts fulfilling the same conditions. The notification obligation shall not cover price information and shall not apply to the modifications related only to the gas price. The notification obligation shall also apply to all commercial agreements that are relevant for the execution of the gas supply contract excluding price information. The competent authority shall notify the data listed in point (a) of the first subparagraph to the Commission in an anonymised form. In the event of new contracts being concluded or changes being made to existing contracts, the whole set of data shall be notified by the end of September of the relevant year. Where the competent authority has doubts whether a given contract obtained under point (b) of the first subparagraph puts the security of gas supply of a Member State or a region at risk, it shall notify the contract to the Commission. 7. In circumstances duly justified by the need to guarantee transparency of key gas supply contracts relevant to the security of gas supply, and where the competent authority of the most affected Member State or the Commission considers that a gas supply contract may jeopardise the security of gas supply of a Member State, of a region or of the Union, the competent authority of the Member State or the Commission may request the natural gas undertaking to provide the contract, excluding price information, for the assessment of its impact on the security of gas supply. The request shall be reasoned and may cover also details of any other commercial agreements that are relevant for the execution of the gas supply contract excluding price information. The justification shall include the proportionality of the administrative burden involved. 8. The competent authorities that receive information on the basis of point (b) of paragraph 6 or paragraph 7 of this Article shall assess the received information for security of gas supply purposes within three months and submit the results of their assessment to the Commission. 9. The competent authority shall take into account the information received under this Article in the preparation of the risk assessment, preventive action plan and emergency plan or their respective updates. The Commission may adopt an opinion proposing to the competent authority to amend the risk assessments or plans on the basis of the information received under this Article. The competent authority concerned shall review the risk assessment and the plans concerned by the request in accordance with the procedure set out in Article 8(9). 10. By 2 May 2019, the Member States shall lay down the rules on penalties applicable to infringements by natural gas undertakings of paragraph 6 or 7 of this Article and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. 11. For the purpose of this Article, \u2018the most affected Member State\u2019 shall mean a Member State where a contract party of a given contract has the most of its sales of gas or customers located. 12. All contracts or contractual information received on the basis of paragraphs 6 and 7 as well as the respective assessments by the competent authorities or the Commission shall remain confidential. The competent authorities and the Commission shall ensure full confidentiality. Article 15 Professional secrecy 1. Any commercially sensitive information received, exchanged or transmitted pursuant to Article 14(4) to (8), and Article 18 excluding the results of the assessments referred to in Article 14(3) and (5) shall be confidential and subject to the conditions of professional secrecy laid down in this Article. 2. The obligation of professional secrecy shall apply to the following persons who receive confidential information in accordance with this Regulation: (a) persons who work or who have worked for the Commission; (b) auditors and experts instructed by the Commission; (c) persons who work or who have worked for the competent authorities and the national regulatory authorities or for other relevant authorities; (d) auditors and experts instructed by competent authorities and national regulatory authorities or by other relevant authorities. 3. Without prejudice to cases covered by criminal law, the other provisions of this Regulation or other relevant Union law, confidential information received by the persons referred to in paragraph 2 in the course of their duties may not be divulged to any other person or authority, except in summary or aggregate form such that an individual market participant or market place cannot be identified. 4. Without prejudice to cases covered by criminal law, the Commission, the competent authorities and the national regulatory authorities, bodies or persons which receive confidential information pursuant to this Regulation may use confidential information only in the performance of their duties and for the exercise of their functions. Other authorities, bodies or persons may use that information for the purpose for which it was provided to them or in the context of administrative or judicial proceedings specifically related to the exercise of their functions. Article 16 Cooperation with the Energy Community Contracting Parties 1. Where the Member States and the Energy Community Contracting Parties cooperate in the process of the establishment of risk assessments and preventive action plans and emergency plans, such cooperation may include, in particular, identifying the interaction and correlation of risks and consultations with a view to ensuring consistency of preventive action plans and emergency plans across the border. 2. With respect to paragraph 1, Energy Community Contracting Parties may participate in the GCG upon invitation by the Commission on all matters of mutual concern. Article 17 Monitoring by the Commission The Commission shall carry out continuous monitoring of security of gas supply measures and report regularly to the GCG. The Commission, on the basis of the assessments referred to in Article 8(7) shall, by 1 September 2023, draw conclusions as to possible means to enhance the security of gas supply at Union level and submit a report to the European Parliament and to the Council on the application of this Regulation, including, where necessary, legislative proposals to amend this Regulation. Article 18 Notifications The risk assessment, the preventive action plans, the emergency plans and all other documents shall be notified to the Commission electronically through the CIRCABC platform. All correspondence in connection with a notification shall be transmitted electronically. Article 19 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3(8), Article 7(5) and Article 8(5) shall be conferred on the Commission for a period of five years from 1 November 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 3(8), Article 7(5) and Article 8(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 3(8), Article 7(5) and Article 8(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 20 Derogation 1. This Regulation shall not apply to Malta and Cyprus for as long as no gas is supplied on their respective territories. For Malta and Cyprus the obligations laid down in, and the choices those Member States are entitled to make pursuant to, the following provisions shall be fulfilled and made within the specified time calculated from the date when gas is first supplied on their respective territories: (a) for point 5 of Article 2, Article 3(2), Article 7(5) and point (a) of Article 14(6): 12 months; (b) for Article 6(1): 18 months; (c) for Article 8(7): 24 months; (d) for Article 5(4): 36 months; (e) for Article 5(1): 48 months. In order to fulfil the obligation contained in Article 5(1), Malta and Cyprus may apply the provisions contained in Article 5(2), including by using non-market-based demand-side measures. 2. Obligations related to the work of the risk groups set out in Articles 7 and 8 with regard to the Southern Gas Corridor and Eastern Mediterranean risk groups shall start to apply from the date when the major infrastructure/pipeline enters the test operation. 3. For as long as Sweden has access to gas via interconnections exclusively from Denmark as its only source of gas and its only possible provider of solidarity, Denmark and Sweden shall be exempted from the obligation in Article 13(10) to conclude technical, legal and financial arrangements for the purpose of Sweden providing solidarity to Denmark. This shall not affect the obligation of Denmark to provide solidarity and to conclude the necessary technical, legal and financial arrangements to that effect pursuant to Article 13. Article 21 Repeal Regulation (EU) No 994/2010 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IX. Article 22 Entry into force This Regulation shall enter into force on the fourth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 November 2017. However, Article 13(1) to (6), the first and second subparagraphs of Article 13(8), and Article 13(14) and (15) shall apply from 1 December 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 October 2017. For the European Parliament The President A. TAJANI For the Council The President M. MAASIKAS (1) OJ C 487, 28.12.2016, p. 70. (2) Position of the European Parliament of 12 September 2017 (not yet published in the Official Journal) and decision of the Council of 9 October 2017. (3) Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJ L 211, 14.8.2009, p. 55). (4) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94). (5) Regulation (EC) No 713/2009 of the European Parliament and of the Council of 13 July 2009 establishing an Agency for the Cooperation of Energy Regulators (OJ L 211, 14.8.2009, p. 1). (6) Regulation (EC) No 714/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the network for cross-border exchanges in electricity and repealing Regulation (EC) No 1228/2003 (OJ L 211, 14.8.2009, p. 15). (7) Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (OJ L 211, 14.8.2009, p. 36). (8) Regulation (EU) No 994/2010 of the European Parliament and of the Council of 20 October 2010 concerning measures to safeguard security of gas supply and repealing Council Directive 2004/67/EC (OJ L 295, 12.11.2010, p. 1). (9) Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924). (10) Directive 2005/89/EC of the European Parliament and of the Council of 18 January 2006 concerning measures to safeguard security of electricity supply and infrastructure investment (OJ L 33, 4.2.2006, p. 22). (11) Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection (OJ L 345, 23.12.2008, p. 75). (12) Commission Regulation (EU) No 312/2014 of 26 March 2014 establishing a Network Code on Gas Balancing of Transmission Networks (OJ L 91, 27.3.2014, p. 15). (13) OJ L 123, 12.5.2016, p. 1. (14) Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulation (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (OJ L 115, 25.4.2013, p. 39). ANNEX I Regional cooperation The risk groups of Member States that serve as the basis for risk associated cooperation as referred to in Article 3(7) are the following: 1. Eastern gas supply risk groups: (a) Ukraine: Bulgaria, Czech Republic, Germany, Greece, Croatia, Italy, Luxembourg, Hungary, Austria, Poland, Romania, Slovenia, Slovakia; (b) Belarus: Belgium, Czech Republic, Germany, Estonia, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Slovakia; (c) Baltic Sea: Belgium, Czech Republic, Denmark, Germany, France, Luxembourg, Netherlands, Austria, Slovakia, Sweden; (d) North-Eastern: Estonia, Latvia, Lithuania, Finland; (e) Trans-Balkan: Bulgaria, Greece, Romania. 2. North Sea gas supply risk groups: (a) Norway: Belgium, Denmark, Germany, Ireland, Spain, France, Italy, Luxembourg, Netherlands, Portugal, Sweden, United Kingdom; (b) Low-calorific gas: Belgium, Germany, France, Netherlands; (c) Denmark: Denmark, Germany, Luxembourg, Netherlands, Sweden; (d) United Kingdom: Belgium, Germany, Ireland, Luxembourg, Netherlands, United Kingdom. 3. North African gas supply risk groups: (a) Algeria: Greece, Spain, France, Croatia, Italy, Malta, Austria, Portugal, Slovenia; (b) Libya: Croatia, Italy, Malta, Austria, Slovenia. 4. South-East gas supply risk groups: (a) Southern Gas Corridor \u2014 Caspian: Bulgaria, Greece, Croatia, Italy, Hungary, Malta, Austria, Romania, Slovenia, Slovakia; (b) Eastern Mediterranean: Greece, Italy, Cyprus, Malta. ANNEX II Calculation of the N \u2013 1 formula 1. Definition of the N \u2013 1 formula The N \u2013 1 formula describes the ability of the technical capacity of the gas infrastructure to satisfy total gas demand in the calculated area in the event of disruption of the single largest gas infrastructure during a day of exceptionally high gas demand occurring with a statistical probability of once in 20 years. Gas infrastructure shall cover the gas transmission network including interconnections, as well as production, LNG and storage facilities connected to the calculated area. The technical capacity of all remaining available gas infrastructure in the event of disruption of the single largest gas infrastructure shall be at least equal to the sum of the total daily gas demand of the calculated area during a day of exceptionally high gas demand occurring with a statistical probability of once in 20 years. The results of the N \u2013 1 formula, as calculated below, shall be at least equal to 100 %. 2. Calculation method of the N \u2013 1 formula , N \u2013 1 \u2265 100 % The parameters used for the calculation shall be clearly described and justified. For the calculation of the EPm, a detailed list of the entry points and their individual capacity shall be provided. 3. Definitions of the parameters of the N \u2013 1 formula \u2018Calculated area\u2019 means a geographical area for which the N \u2013 1 formula is calculated, as determined by the competent authority. Demand-side definition \u2018Dmax\u2019 means the total daily gas demand (in mcm/d) of the calculated area during a day of exceptionally high gas demand occurring with a statistical probability of once in 20 years. Supply-side definitions \u2018EPm\u2019: technical capacity of entry points (in mcm/d), other than production, LNG and storage facilities covered by Pm, LNGm and Sm, means the sum of the technical capacity of all border entry points capable of supplying gas to the calculated area. \u2018Pm\u2019: maximal technical production capability (in mcm/d) means the sum of the maximal technical daily production capability of all gas production facilities which can be delivered to the entry points in the calculated area. \u2018Sm\u2019: maximal technical storage deliverability (in mcm/d) means the sum of the maximal technical daily withdrawal capacity of all storage facilities which can be delivered to the entry points of the calculated area, taking into account their respective physical characteristics. \u2018LNGm\u2019: maximal technical LNG facility capacity (in mcm/d) means the sum of the maximal technical daily send-out capacities at all LNG facilities in the calculated area, taking into account critical elements like offloading, ancillary services, temporary storage and re-gasification of LNG as well as technical send-out capacity to the system. \u2018Im\u2019 means the technical capacity of the single largest gas infrastructure (in mcm/d) with the highest capacity to supply the calculated area. When several gas infrastructures are connected to a common upstream or downstream gas infrastructure and cannot be separately operated, they shall be considered as one single gas infrastructure. 4. Calculation of the N \u2013 1 formula using demand-side measures , N \u2013 1 \u2265 100 % Demand-side definition \u2018Deff\u2019 means the part (in mcm/d) of Dmax that in the case of a disruption of gas supply can be sufficiently and timely covered with market-based demand-side measures in accordance with point (c) of Article 9(1) and Article 5(2). 5. Calculation of the N \u2013 1 formula at regional level The calculated area referred to in point 3 shall be extended to the appropriate regional level, where applicable, as determined by the competent authorities of the Member States concerned. The calculation may also extend to the regional level of the risk group, if so agreed with the competent authorities of the risk group. For the calculation of the N \u2013 1 formula at regional level, the single largest gas infrastructure of common interest shall be used. The single largest gas infrastructure of common interest to a region shall be the largest gas infrastructure in the region that directly or indirectly contributes to gas supply to the Member States of that region and shall be defined in the risk assessment. The calculation of the N \u2013 1 formula at regional level may replace the calculation of the N \u2013 1 formula at national level only where the single largest gas infrastructure of common interest is of major importance for the gas supply of all Member States concerned in accordance with the common risk assessment. On the level of the risk group, for the calculations referred to in Article 7(4), the single largest gas infrastructure of common interest to the risk groups as listed in Annex I shall be used. ANNEX III Permanent bi-directional capacity 1. For the execution of the provisions set out in this Annex the national regulatory authority may act as the competent authority if so decided by the Member State. 2. To enable or enhance bi-directional capacity on an interconnection or to obtain or prolong an exemption from that obligation, transmission system operators on both sides of the interconnection shall submit to their competent authorities (\u2018competent authorities concerned\u2019) and to their regulatory authorities (\u2018regulatory authorities concerned\u2019) after consulting with all transmission system operators potentially concerned: (a) a proposal to enable permanent physical capacity to transport gas in both directions for permanent bi-directional capacity concerning the reverse direction (\u2018physical reverse flow capacity\u2019); or (b) a request for an exemption from the obligation to enable bi-directional capacity. The transmission system operators shall endeavour to submit a joint proposal or request for exemption. In the case of a proposal to enable bi-directional capacity, the transmission system operators may make a substantiated proposal for a cross-border cost allocation. Such submission shall take place no later than 1 December 2018 for all interconnections that existed on 1 November 2017, and after completing the feasibility study phase but before the start of detailed technical design phase for new interconnections. 3. Upon receipt of the proposal or the exemption request the competent authorities concerned shall without delay consult the competent authorities and, where they are not the competent authorities, the national regulatory authorities, of the Member State that could, in accordance with the risk assessment, benefit from the reverse flow capacity, the Agency and the Commission on the proposal or the exemption request. The authorities consulted may issue an opinion within four months of receipt of the consultation request. 4. The regulatory authorities concerned shall within six months upon receipt of the joint proposal, pursuant to Article 5(6) and (7), after consulting the project promoters concerned, take coordinated decisions on the cross-border allocation of investment costs to be borne by each transmission system operator of the project. Where the regulatory authorities concerned have not reached an agreement within that deadline, they shall inform the competent authorities concerned without delay. 5. The competent authorities concerned shall on the basis of the risk assessment, the information listed in Article 5(5) of this Regulation, the opinions received following the consultation in accordance with point 3 of this Annex and taking into account the security of gas supply and the contribution to the internal gas market take a coordinated decision. That coordinated decision shall be taken within two months. The period of two months shall start to run after the four-month period allowed for the opinions referred to under point 3 of this Annex, unless all opinions have been received before, or after the six-month period referred to in point 4 of this Annex for regulatory authorities concerned to adopt a coordinated decision. The coordinated decision shall: (a) accept the proposal for bi-directional capacity. Such decision shall contain a cost benefit analysis, a timeline for implementation and the arrangements for its subsequent use and be accompanied by the coordinated decision on the cross-border cost allocation referred to in point 4 and prepared by the regulatory authorities concerned; (b) grant or prolong a temporary exemption for a maximum period of four years, if the cost-benefit analysis included in the decision shows that the reverse flow capacity would not enhance the security of gas supply of any relevant Member State or if the investment costs would significantly outweigh the prospective benefits for the security of gas supply; or (c) require the transmission system operators to amend and resubmit their proposal or exemption request within a maximum period of four months. 6. The competent authorities concerned shall submit the coordinated decision without delay to the competent authorities and national regulatory authorities who have submitted an opinion in accordance with point 3, the regulatory authorities concerned, the Agency and the Commission including the opinions received following the consultation in accordance with point 3. 7. Within two months of receipt of the coordinated decision, the competent authorities referred to in point 6 may present their objections to the coordinated decision and submit them to the competent authorities concerned that adopted it, the Agency and the Commission. The objections shall be limited to facts and assessment, in particular cross-border cost allocation that was not subject of consultation in accordance with point 3. 8. Within three months of receipt of the coordinated decision in accordance with point 6, the Agency shall issue an opinion on the elements of the coordinated decision taking into account any possible objection and submit the opinion to all competent authorities concerned and the competent authorities referred to in point 6 and to the Commission. 9. Within four months of receipt of the opinion issued by the Agency pursuant to point 8 the Commission may adopt a decision requesting modifications of the coordinated decision. Any such decision of the Commission shall be taken on the basis of: the criteria set out in point 5, the reasons for the decision of the authorities concerned and the opinion of the Agency. The competent authorities concerned shall comply with the request of the Commission by amending their decision within a period of four weeks. In the event that the Commission does not act within the aforementioned four months period, it shall be considered not to have raised objections to the decision of the competent authorities concerned. 10. If the competent authorities concerned were not able to adopt a coordinated decision within the deadline set out in point 5 or if the regulatory authorities concerned could not reach an agreement on the cost allocation within the deadline set out in point 4, the competent authorities concerned shall inform the Agency and the Commission at the latest on the day of the expiry of the deadline. Within four months of receipt of that information, the Commission, after possible consultation with the Agency, shall adopt a decision covering all elements of a coordinated decision listed in point 5 with the exception of a cross-border cost allocation and submit that decision to the competent authorities concerned and the Agency. 11. If the Commission decision pursuant to point 10 of this Annex, requires bi-directional capacity, the Agency shall adopt a decision covering the cross-border cost allocation in line with Article 5(7) of this Regulation within three months of receipt of the Commission decision. Before taking such a decision, the Agency shall consult the regulatory authorities concerned and the transmission system operators. The three-month period may be extended by an additional period of two months where the Agency has to request additional information. The additional period shall begin on the day following receipt of the complete information. 12. The Commission, the Agency, the competent authorities, the national regulatory authorities and the transmission system operators shall preserve the confidentiality of commercially sensitive information. 13. Exemptions from the obligation to enable bi-directional capacity granted under Regulation (EU) No 994/2010 shall remain valid unless the Commission or the other concerned Member State requests a revision or their duration expires. ANNEX IV Template for the common risk assessment The following template shall be completed in a language agreed within the risk group. General information \u2014 Member States in the risk group \u2014 Name of the competent authorities responsible for the preparation of the risk assessment (1) 1. Description of the system Provide a brief description of the gas system of the risk group, covering: (a) the main gas consumption figures (2): annual final gas consumption (bcm) and breakdown per type of customers (3), peak demand (total and breakdown per category of consumer in mcm/d); (b) a description of the functioning of the gas system in the risk group: main flows (entry/exit/transit), entry/exit point's infrastructure capacity to and out of the region and per Member State, including utilisation rate, LNG facilities (maximal daily capacity, utilisation rate and access regime), etc.; (c) a breakdown, to the extent possible, of gas import sources per country of origin (4); (d) a description of the role of storage facilities relevant for the risk group, including cross-border access: (i) the storage capacity (total and working gas) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (e) a description of the role of domestic production in the risk group: (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity; (f) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity). 2. Infrastructure standard (Article 5) Describe the calculations of the N \u2013 1 formula(s) at regional level for the risk group, if so agreed with the competent authorities of the risk group, and the existing bidirectional capacities, as follows: (a) N \u2013 1 formula (i) the identification of the single largest gas infrastructure of common interest for the risk group; (ii) the calculation of the N \u2013 1 formula at regional level; (iii) a description of the values used for all elements in the N \u2013 1 formula, including intermediate figures used for the calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (iv) an indication of the methodologies and assumptions used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations); (b) bi-directional capacity (i) indicate the interconnection points equipped with bidirectional capacity and the maximal capacity of bi-directional flows; (ii) indicate the arrangements governing the use of the reverse flow capacity (e.g. interruptible capacity); (iii) indicate interconnection points where an exemption has been granted in accordance with Article 5(4), the duration of the exemption and the grounds on which it was granted. 3. Identification of risks Describe the major transnational risk for which the group was created as well as the risk factors at several instances which could make that risk materialise, their likelihood and consequences. Non-exhaustive list of risk factors that have to be included in the assessment only if applicable according to the relevant competent authority: (a) political \u2014 gas disruption from third countries because of different reasons, \u2014 political unrest (either in country of origin or in transit country), \u2014 war/civil war (either in country of origin or in transit country), \u2014 terrorism; (b) technological \u2014 explosion/fires, \u2014 fires (internal to a given facility), \u2014 leakages, \u2014 lack of adequate maintenance, \u2014 equipment malfunction (failure to start, failure during working time, etc.), \u2014 lack of electricity (or other energy source), \u2014 ICT failure (hardware or software failure, internet, SCADA problems, etc.), \u2014 cyber-attack, \u2014 impact due to excavation works (digging, piling), ground works, etc.; (c) commercial/market/financial \u2014 agreements with third-country suppliers, \u2014 commercial dispute, \u2014 control of infrastructure relevant for the security of gas supply by third-country entities, which may imply, among others, risks of underinvestment, undermining diversification or non-respect of Union law, \u2014 price volatility, \u2014 underinvestment, \u2014 sudden, unexpected peak demand, \u2014 other risks which could lead to structural underperformance; (d) social \u2014 strikes (in different related sectors, such as the gas sector, ports, transport, etc.), \u2014 sabotage, \u2014 vandalism, \u2014 theft; (e) natural \u2014 earthquakes, \u2014 landslides, \u2014 floods (heavy rain, river), \u2014 storms (sea), \u2014 avalanches, \u2014 extreme weather conditions, \u2014 fires (external to the facility, like nearby forests, grassland, etc.). Analysis (a) describe the major transnational risk and any other relevant risk factors for the risk group, including their likelihood and impact as well as the interaction and correlation of risks among Member States, as appropriate; (b) describe the criteria used to determine whether a system is exposed to high/unacceptable risks; (c) set a list of relevant risk scenarios in accordance with the sources of risks and describe how the selection was made; (d) indicate the extent to which scenarios prepared by ENTSOG have been considered. 4. Risk analysis and assessment Analyse the set of relevant risk scenarios identified under point 3. In the simulation of risk scenarios include the existing security of gas supply measures, such as, the infrastructure standard calculated using the N \u2013 1 formula as set out in point 2 of Annex II, if appropriate, and the gas supply standard. Per risk scenario: (a) describe in detail the risk scenario, including all assumptions and, if applicable, the underlying methodologies for their calculation; (b) describe in detail the results of the simulation carried out, including a quantification of the impact (e.g. volumes of unserved gas, the socioeconomic impact, the impact on district heating, the impact on electricity generation). 5. Conclusions Describe the main results of the common risk assessment, including the identification of risk scenarios that require further action. (1) Where this task has been delegated by any competent authority, indicate the name of the body/(ies) responsible for the preparation of the present risk assessment on its behalf. (2) For the first assessment, include data from the last two years. For updates, include data from the last four years. (3) Including industrial customers, electricity generation, district heating, residential and services and other (please specify the type of customers included here). Indicate as well the volume of consumption of protected customers. (4) Describe the methodology applied. ANNEX V Template for the national risk assessment General information Name of the competent authority responsible for the preparation of the present risk assessment (1). 1. Description of the system 1.1. Provide a brief consolidated description of the regional gas system for each risk group (2) the Member State participates in, covering: (a) the main gas consumption figures (3): annual final gas consumption (bcm and MWh) and breakdown per type of customers (4), peak demand (total and breakdown per category of consumer in mcm/d); (b) a description of the functioning of the gas system(s) in the relevant risk groups: main flows (entry/exit/transit), entry/exit point's infrastructure capacity to and out of the risk groups' region(s) and per Member State, including utilisation rate, LNG facilities (maximal daily capacity, utilisation rate and access regime), etc.; (c) a breakdown, to the extent possible, of percentage gas import sources per country of origin (5); (d) a description of the role of storage facilities relevant for the risk group, including cross-border access: (i) the storage capacity (total and working gas) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (e) a description of the role of domestic production in the risk group(s): (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity and description of how it can cover maximum daily consumption; (f) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity). 1.2. Provide a brief description of the gas system of the Member State, covering: (a) the main gas consumption figures: annual final gas consumption (bcm) and breakdown by type of customers, peak demand (mcm/d); (b) a description of the functioning of the gas system at national level, including infrastructure (to the extent not covered by point 1.1(b)). If applicable, include L-gas system; (c) the identification of the key infrastructure relevant for the security of gas supply; (d) a breakdown, to the extent possible, at national level of gas import sources per country of origin; (e) a description of the role of storage and include: (i) the storage capacity (total and working) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (f) a description of the role of domestic production and include: (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity; (g) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity). 2. Infrastructure standard (Article 5) Describe how the infrastructure standard is complied with, including the main values used for the N \u2013 1 formula and alternative options for its compliance (with directly connected Member States, demand-side measures) and the existing bidirectional capacities, as follows: (a) N \u2013 1 formula (i) the identification of the single largest gas infrastructure; (ii) the calculation of the N \u2013 1 formula at national level; (iii) a description of the values used for all elements in the N \u2013 1 formula, including intermediate values used for their calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (iv) an indication of the methodologies used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations); (v) an explanation of the results of the calculation of the N \u2013 1 formula considering the level of storages at 30 % and 100 % of the maximum working volume; (vi) an explanation of the main results of the simulation of the N \u2013 1 formula using a hydraulic model; (vii) if so decided by the Member State, a calculation of the N \u2013 1 formula using demand-side measures: \u2014 calculation of the N \u2013 1 formula in accordance with point 2 of Annex II, \u2014 description of the values used for all elements in the N \u2013 1 formula, including intermediate figures used for the calculation (if different to the figures described under point 2(a)(iii)), \u2014 indicate the methodologies used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations), \u2014 explain the market-based demand-side measures adopted/to be adopted to compensate a disruption of gas supply and its expected impact (Deff); (viii) if so agreed with the competent authorities of the relevant risk group(s) or with directly connected Member States, joint calculation(s) of the N \u2013 1 formula: \u2014 calculation of the N \u2013 1 formula in accordance with point 5 of Annex II, \u2014 description of the values used for all elements in the N \u2013 1 formula, including intermediate values used for their calculation (if different to the figures described under point 2(a)(iii)), \u2014 indicate the methodologies and assumptions used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations), \u2014 explain the agreed arrangements to ensure compliance with the N \u2013 1 formula; (b) bi-directional capacity (i) indicate the interconnection points equipped with bidirectional capacity and the maximal capacity of bi-directional flows; (ii) indicate the arrangements governing the use of the reverse flow capacity (e.g. interruptible capacity); (iii) indicate interconnection points where an exemption has been granted in accordance with Article 5(4), the duration of the exemption and the grounds on which it was granted. 3. Identification of risks Describe the risk factors which could have negative impact on the security of gas supply in the Member State, their likelihood and consequences. Non-exhaustive list of types of risk factors that have to be included in the assessment only if applicable according to the competent authority: (a) political \u2014 gas disruption from third countries because of different reasons, \u2014 political unrest (either in country of origin or in transit country), \u2014 war/civil war (either in country of origin or in transit country), \u2014 terrorism; (b) technological \u2014 explosion/fires, \u2014 fires (internal to a given facility), \u2014 leakages, \u2014 lack of adequate maintenance, \u2014 equipment malfunction (failure to start, failure during working time, etc.), \u2014 lack of electricity (or other energy source), \u2014 ICT failure (hardware or software failure, internet, SCADA problems, etc.), \u2014 cyber-attack, \u2014 impact due to excavation works (digging, piling), ground works, etc.; (c) commercial/market/financial \u2014 agreements with third-country suppliers, \u2014 commercial dispute, \u2014 control of infrastructure relevant for the security of gas supply by third-country entities, which may imply, among others, risks of underinvestment, undermining diversification or non-respect of Union law, \u2014 price volatility, \u2014 underinvestment, \u2014 sudden, unexpected peak demand, \u2014 other risks which could lead to structural underperformance; (d) social \u2014 strikes (in different related sectors, such as the gas sector, ports, transport, etc.), \u2014 sabotage, \u2014 vandalism, \u2014 theft; (e) natural \u2014 earthquakes, \u2014 landslides, \u2014 floods (heavy rain, river), \u2014 storms (sea), \u2014 avalanches, \u2014 extreme weather conditions, \u2014 fires (external to the facility, like nearby forests, grassland, etc.). Analysis (a) identify the relevant risk factors for the Member State, including their likelihood and impact; (b) describe the criteria used to determine whether a system is exposed to high/unacceptable risks; (c) set a list of relevant risk scenarios in accordance with the risk factors and their likelihood and describe how the selection was made. 4. Risk analysis and assessment Analyse the set of relevant risk scenarios identified under point 3. In the simulation of risk scenarios include the existing security of gas supply measures, such as the infrastructure standard calculated using the N \u2013 1 formula as set out in point 2 of Annex II, and the gas supply standard. Per risk scenario: (a) describe in detail the risk scenario, including all assumptions and, if applicable, the underlying methodologies for their calculation; (b) describe in detail the results of the simulation carried out, including a quantification of the impact (e.g. volumes of unserved gas, the socioeconomic impact, the impact on district heating, the impact on electricity generation). 5. Conclusions Describe the main results of the common risk assessment the Member States has been involved in, including the identification of risk scenarios that require further action. (1) Where this task has been delegated by the competent authority, indicate the name of the body/(ies) responsible for the preparation of the present risk assessment on its behalf. (2) For the sake of simplicity, present the information at the highest level of the risk groups if possible and merge details as necessary. (3) For the first assessment, include data from the last two years. For updates, include data from the last four years. (4) Including industrial customers, electricity generation, district heating, residential and services and other (specify the type of customers included here). Indicate as well the volume of consumption of protected customers. (5) Describe the methodology applied. ANNEX VI Template for preventive action plan General information \u2014 Member States in the risk group \u2014 Name of the competent authority responsible for the preparation of the plan (1) 1. Description of the system 1.1. Provide a brief consolidated description of the regional gas system for each risk group (2) the Member States participates in, covering: (a) the main gas consumption figures (3): annual final gas consumption (bcm) and breakdown per type of customers (4), peak demand (total and breakdown per category of consumer in mcm/d); (b) a description of the functioning of the gas system in the risk groups: main flows (entry/exit/transit), entry/exit point's infrastructure capacity to and out of the risk group's region(s) and per Member State, including utilisation rate, LNG facilities (maximal daily capacity, utilisation rate and access regime), etc.; (c) a breakdown, to the extent possible, of gas import sources per country of origin (5); (d) a description of the role of storage facilities relevant for the region, including cross-border access: (i) the storage capacity (total and working gas) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (e) a description of the role of domestic production in the region: (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity; (f) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity); (g) a description of the role of energy efficiency measures and their effect on annual final gas consumption. 1.2. Provide a brief description of the gas system per Member State, covering: (a) the main gas consumption figures: annual final gas consumption (bcm) and breakdown by type of customers, peak demand (mcm/d); (b) a description of the functioning of the gas system at national level, including infrastructure (to the extent not covered by point 1.1(b)); (c) the identification of the key infrastructure relevant for the security of supply; (d) a breakdown, to the extent possible, at national level of gas import sources per country of origin; (e) a description of the role of storage in the Member State and include: (i) the storage capacity (total and working) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (f) a description of the role of domestic production and include: (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity; (g) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity); (h) a description of the role of energy efficiency measures and their effect on annual final gas consumption. 2. Summary of the risk assessment Describe briefly the results of the relevant common and national risk assessment carried out in accordance with Article 7, including: (a) a list of the scenarios assessed and a brief description of the assumptions applied for each one as well as the risks/shortcomings identified; (b) the main conclusions of the risk assessment. 3. Infrastructure standard (Article 5) Describe how the infrastructure standard is complied with, including the main values used for the N \u2013 1 formula and alternative options for its compliance (with neighbouring Member States, demand-side measures) and the existing bidirectional capacities, as follows: 3.1. N \u2013 1 formula (i) the identification of the single largest gas infrastructure of common interest for the region; (ii) the calculation of the N \u2013 1 formula at regional level; (iii) a description of the values used for all elements in the N \u2013 1 formula, including intermediate figures used for the calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (iv) an indication of the methodologies and assumptions used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations). 3.2. National level (a) N \u2013 1 formula (i) the identification of the single largest gas infrastructure; (ii) the calculation of the N \u2013 1 formula at national level; (iii) a description of the values used for all elements in the N \u2013 1 formula, including intermediate values used for the calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (iv) an indication of the methodologies used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations); (v) if so decided by the Member State, calculation of the N \u2013 1 formula using demand-side measures: \u2014 the calculation of the N \u2013 1 formula in accordance with point 2 of Annex II, \u2014 a description of the values used for all elements in the N \u2013 1 formula, including intermediate figures used for the calculation (if different to the figures described under point 3(a)(iii) of this Annex), \u2014 an indication of the methodologies used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations), \u2014 an explanation of the market-based demand-side measures adopted/to be adopted to compensate a disruption of gas supply and its expected impact (Deff); (vi) if so agreed with the competent authorities of the relevant risk group(s) or with the directly connected Member States, joint calculation(s) of the N \u2013 1 formula: \u2014 the calculation of the N \u2013 1 formula in accordance with point 5 of Annex II, \u2014 a description of the values used for all elements in the N \u2013 1 formula, including intermediate values used for the calculation (if different to the figures described under point 3(a)(iii) of this Annex), \u2014 an indication of the methodologies and assumptions used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations), \u2014 an explanation of the agreed arrangements to ensure compliance with the N \u2013 1 formula; (b) bi-directional capacity (i) indicate the interconnection points equipped with bidirectional capacity and the maximal capacity of bi-directional flows; (ii) indicate the arrangements governing the use of the reverse flow capacity (e.g. interruptible capacity); (iii) indicate interconnection points where an exemption has been granted in accordance with Article 5(4), the duration of the exemption and the grounds on which it was granted. 4. Compliance with the supply standard (Article 6) Describe the measures adopted in order to comply with the supply standard as well as with any increased supply standard or additional obligation imposed for reasons of security of gas supply: (a) definition of protected customers applied, including categories of customers covered and their annual gas consumption (per category, net value and percentage of the national annual final gas consumption); (b) gas volumes needed to comply with the supply standard in accordance with the scenarios described in the first subparagraph of Article 6(1); (c) capacity needed to comply with the supply standard in accordance with the scenarios described in the first subparagraph of Article 6(1); (d) measure(s) in place to comply with the supply standard: (i) a description of the measure(s); (ii) addressees; (iii) where it exists, describe any ex ante monitoring system for the compliance with the supply standard; (iv) sanctions regime, if applicable; (v) describe, per measure: \u2014 the economic impact, effectiveness and efficiency of the measure, \u2014 the impact of the measure on the environment, \u2014 impact of the measures on consumer, (vi) where non-market-based measures are applied (per measure): \u2014 justify why the measure is necessary (i.e. why security of supply cannot be achieved via market-based measures alone), \u2014 justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect), \u2014 provide an analysis of the impact of such measure: (1) on other Member State's security of supply; (2) on the national market; (3) on the internal market; (vii) where measures introduced on or after 1 November 2017, please provide a short summary of the impact assessment or a link to the public impact assessment of the measure(s) carried out in accordance with Article 9(4); (e) if applicable, describe any increased supply standard or additional obligation imposed for reasons of security of gas supply: (i) a description of the measure(s); (ii) the mechanism to reduce it to usual values in a spirit of solidarity and in accordance with Article 13; (iii) if applicable, describe any new increased supply standard or additional obligation imposed for reasons of security of gas supply adopted on or after 1 November 2017; (iv) addressees; (v) affected gas volumes and capacities; (vi) indicate how that measure complies with the conditions laid down in Article 6(2). 5. Preventive measures Describe the preventive measures in place or to be adopted: (a) describe each of the preventive measures adopted per identified risk in accordance with the risk assessment, including a description of: (i) their national or regional dimension; (ii) their economic impact, effectiveness and efficiency; (iii) their impact on customers. Where appropriate, include: \u2014 measures to enhance interconnections between neighbouring Member States, \u2014 measures to diversify gas routes and sources of supply, \u2014 measures to protect key infrastructure relevant for the security of supply in relation to control by third-country entities (including, where relevant, general or sector-specific investment screening laws, special rights for certain shareholders, etc.); (b) describe other measures adopted for reasons other than the risk assessment but with a positive impact for the security of supply of the relevant risk group(s) Member State. (c) where non-market-based measures are applied (per measure): (i) justify why the measure is necessary (i.e. why the security of supply cannot be achieved via market-based measures alone); (ii) justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect); (iii) provide an analysis of the impact of such measure: \u2014 justify why the measure is necessary (i.e. why the security of supply cannot be achieved via market-based measures alone), \u2014 justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect), \u2014 provide an analysis of the impact of such measure: (1) on other Member State's security of supply; (2) on the national market; (3) on the internal market; (4) explain the extent to which efficiency measures, including on the demand side, have been considered to increase the security of supply; (5) explain the extent to which renewable energy sources have been considered to increase the security of supply. 6. Other measures and obligations (e.g. safety operation of the system) Describe other measures and obligations that have been imposed on natural gas undertakings and other relevant bodies likely to have an impact on the security of gas supply, such as obligations for the safe operation of the system, including who would be affected by that obligation as well as the gas volumes covered. Explain precisely when and how those measures would apply. 7. Infrastructure projects (a) describe future infrastructure projects, including Projects of Common Interests in the relevant risk groups, including an estimated timing for their deployment, capacities and estimated impact on the security of gas supply in the risk group; (b) indicate how the infrastructure projects take into account the Union-wide TYNDP elaborated by ENTSOG pursuant to Article 8(10) of Regulation (EC) No 715/2009. 8. Public service obligations related to the security of supply Indicate the existing public service obligations related to the security of supply and briefly describe them (use annexes for more detailed information). Explain clearly who has to comply with such obligations and how. If applicable, describe how and when those public service obligations would be triggered. 9. Stakeholder consultations In accordance with Article 8(2) of this Regulation, describe the mechanism used for and the results of the consultations carried out, for the development of the plan as well as the emergency plan, with: (a) gas undertakings; (b) relevant organisations representing the interests of households; (c) relevant organisations representing the interests of industrial gas customers, including electricity producers; (d) national regulatory authority. 10. Regional dimension Indicate any national circumstances and measures relevant for the security of supply and not covered in the previous sections of the plan. Indicate how the possible comments received following the consultation described in Article 8(2) have been considered. 11.1. Calculation of the N \u2013 1 at the level of the risk group if so agreed by the competent authorities of the risk group N \u2013 1 formula (a) the identification of the single largest gas infrastructure of common interest for the risk group; (b) the calculation of the N \u2013 1 formula at the level of the risk group; (c) a description of the values used for all elements in the N \u2013 1 formula, including intermediate figures used for the calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (d) an indication of the methodologies and assumptions used, if any, for the calculation of parameters in the N \u2013 1 formula (e.g. Dmax) (use annexes for detailed explanations). 11.2. Mechanisms developed for cooperation Describe the mechanisms used for the cooperation among the Member States in the relevant risk groups, including for developing cross-border measures in the preventive action plan and the emergency plan. Describe the mechanisms used for the cooperation with other Member States in the design and adoption of the provisions necessary for the application of Article 13. 11.3. Preventive measures Describe the preventive measures in place or to be adopted in the risk group or as a result of regional agreements: (a) describe each of the preventive measures adopted per identified risk in accordance with the risk assessment, including a description of: (i) their impact in the Member States of the risk group; (ii) their economic impact, effectiveness and efficiency; (iii) their impact on the environment; (iv) their impact on customers. Where appropriate, include: \u2014 measures to enhance interconnections between neighbouring Member States, \u2014 measures to diversify gas routes and sources of supply, \u2014 measures to protect key infrastructure relevant for the security of supply in relation to control by third-country entities (including, where relevant, general or sector-specific investment screening laws, special rights for certain shareholders, etc.); (b) describe other measures adopted for reasons other than the risk assessment but with a positive impact for the security of supply of the risk group. (c) where non-market-based measures are applied (per measure): (i) justify why the measure is necessary (i.e. why the security of supply cannot be achieved via market-based measures alone); (ii) justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect); (iii) provide an analysis of the impact of such a measure: \u2014 justify why the measure is necessary (i.e. why the security of supply cannot be achieved via market-based measures alone), \u2014 justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect), \u2014 provide an analysis of the impact of such a measure: (1) on other Member State's security of supply; (2) on the national market; (3) on the internal market; (d) explain the extent to which efficiency measures, including on the demand side, have been considered to increase the security of supply; (e) explain the extent to which renewable energy sources have been considered to increase the security of supply. (1) Where this task has been delegated by any competent authority, indicate the name of the body/(ies) responsible for the preparation of this plan on its behalf. (2) For the sake of simplicity, present the information at the highest level of the risk groups if possible and merge details as necessary (3) For the first plan, include data from the last two years. For updates, include data from the last four years. (4) Including industrial customers, electricity generation, district heating, residential and services and other (please specify the type of customers included here). (5) Describe the methodology applied. ANNEX VII Template for emergency plan General information Name of the competent authority responsible for the preparation of the present plan (1) 1. Definition of crisis levels (a) indicate the body responsible for the declaration of each crisis level and the procedures to follow in each case for such declarations; (b) where they exist, include here indicators or parameters used to consider whether an event may result in a significant deterioration of the supply situation and to decide upon the declaration of a certain crisis level. 2. Measures to be adopted per crisis level (2) 2.1. Early Warning Describe the measures to be applied at this stage, indicating, per measure: (i) a brief description of the measure and main actors involved; (ii) describe the procedure to follow, if applicable; (iii) indicate the expected contribution of the measure to cope with the impact of any event or prepare ahead of its appearance; (iv) describe the flows of information among the actors involved. 2.2. Alert Level (a) describe the measures to be applied at this stage, indicating, per measure: (i) a brief description of the measure and main actors involved; (ii) describe the procedure to follow, if applicable; (iii) indicate the expected contribution of the measure to cope with the situation at alert level; (iv) describe the flows of information among the actors involved; (b) describe the reporting obligations imposed on natural gas undertakings at alert level. 2.3. Emergency Level (a) establish a list of predefined actions on the supply and demand side to make gas available in the event of an emergency, including commercial agreements between the parties involved in such actions and the compensation mechanisms for natural gas undertakings where appropriate; (b) describe the market-based measures to be applied at this stage, indicating, per measure: (i) a brief description of the measure and main actors involved; (ii) describe the procedure to follow; (iii) indicate the expected contribution of the measure to mitigate the situation at emergency level; (iv) describe the flows of information among the actors involved; (c) describe the non-market-based measures planned or to be implemented for the emergency level, indicating, per measure: (i) a brief description of the measure and main actors involved; (ii) provide an assessment of the necessity of such measure in order to cope with a crisis, including the degree of its use; (iii) describe in detail the procedure to implement the measure (e.g. what would trigger the introduction of this measure, who would take the decision); (iv) indicate the expected contribution of the measure to mitigate the situation at emergency level as a complement to market-based measures; (v) assess other effects of the measure; (vi) justify the compliance of the measure with the conditions laid down in Article 11(6); (vii) describe the flows of information among the actors involved; (d) describe reporting obligations imposed on natural gas undertakings. 3. Specific measures for the electricity and district heating (a) district heating (i) briefly indicate the likely impact of a disruption of gas supply in the district heating sector; (ii) indicate measures and actions to be taken to mitigate the potential impact of a disruption of gas supply on district heating. Alternatively, indicate why the adoption of specific measures is not appropriate; (b) supply of electricity generated from gas (i) briefly indicate the likely impact of a disruption of gas supply in the electricity sector; (ii) indicate measures and actions to be taken to mitigate the potential impact of a disruption of gas supply on the electricity sector. Alternatively, indicate why the adoption of specific measures is not appropriate; (iii) indicate the mechanisms/existing provisions to ensure appropriate coordination, including exchange of information, between main actors in the gas and electricity sectors, in particular transmission system operators at different crisis levels. 4. Crisis manager or team Indicate who the crisis manager is and define its role. 5. Roles and responsibilities of different actors (a) per crisis level, define the roles and responsibilities, including interactions with the competent authorities and, where appropriate, with the national regulatory authority, of: (i) natural gas undertakings; (ii) industrial customers; (iii) relevant electricity producers; (b) per crisis level, define the role and responsibilities of the competent authorities and the bodies to which tasks have been delegated. 6. Measures regarding undue consumption by customers who are not protected customers Describe measures in place to prevent to the extent possible and without endangering the safe and reliable operation of the gas system or creating unsafe situations, the consumption by customers who are not protected customers of gas supply intended for protected customers during an emergency. Indicate the nature of the measure (administrative, technical, etc.), main actors and the procedures to follow. 7. Emergency tests (a) indicate the calendar for the real time response simulations of emergency situations; (b) indicate actors involved, procedures and concrete high and medium impact scenarios simulated. For the updates of the emergency plan: describe briefly the tests carried out since the last emergency plan was presented and the main results. Indicate which measures have been adopted as a result of those tests. 8. Regional Dimension 8.1. Measures to be adopted per crisis level: 8.1.1. Early Warning Describe the measures to be applied at this stage, indicating, per measure: (i) brief description of the measure and main actors involved; (ii) describe the procedure to follow, if applicable; (iii) indicate the expected contribution of the measure to cope with the impact of any event or prepare ahead of its appearance; (iv) describe the flows of information among the actors involved. 8.1.2. Alert Level (a) describe the measures to be applied at this stage, indicating, per measure: (i) brief description of the measure and main actors involved; (ii) describe the procedure to follow, if applicable; (iii) indicate the expected contribution of the measure to cope with the impact of any event or prepare ahead of its appearance; (iv) describe the flows of information among the actors involved; (b) describe the reporting obligations imposed on natural gas undertakings at alert. level. 8.1.3. Emergency Level (a) establish a list of predefined actions on the supply and demand side to make gas available in the event of an emergency, including commercial agreements between the parties involved in such actions and the compensation mechanisms for natural gas undertakings where appropriate; (b) describe the market-based measures to be applied at this stage, indicating, per measure: (i) brief description of the measure and main actors involved; (ii) describe the procedure to follow; (iii) indicate the expected contribution of the measure to mitigate the situation at emergency level; (iv) describe the flows of information among the actors involved; (c) describe the non-market-based measures planned or to be implemented for the emergency level, indicating, per measure: (i) brief description of the measure and main actors involved; (ii) provide an assessment of the necessity of such measure in order to cope with a crisis, including the degree of its use; (iii) describe in detail the procedure to implement the measure (e.g. what would trigger the introduction of the measure, who would take the decision); (iv) indicate the expected contribution of the measure to mitigate the situation at emergency level as a complement to market-based measures; (v) assess other effects of the measure; (vi) justify the compliance of the measure with the conditions established in Article 11(6); (vii) describe the flows of information among the actors involved; (d) describe reporting obligations imposed on natural gas undertakings. 8.2. Cooperation mechanisms (a) describe the mechanisms in place to cooperate within each of the relevant risk groups and to ensure appropriate coordination for each crisis level. Describe, to the extent they exist and have not been covered in point 2, the decision-making procedures for appropriate reaction at regional level at each crisis level; (b) describe the mechanisms in place to cooperate with other Member States out of the risk groups and to coordinate actions for each crisis level. 8.3. Solidarity among Member States (a) describe the agreed arrangements among directly connected Member States to ensure the application of the solidarity principle referred to in Article 13; (b) if applicable, describe the agreed arrangements between Members States that are connected to each other via a third country to ensure the application of the solidarity principle referred to in Article 13. (1) Where this task has been delegated by any competent authority, please indicate the name of the body/(ies) responsible for the preparation of this plan on its behalf. (2) Include regional and national measures. ANNEX VIII List of non-market-based security of gas supply measures In developing the preventive action plan and the emergency plan the competent authority shall consider the contribution of the following indicative and non-exhaustive list of measures only in the event of an emergency: (a) supply-side measures: \u2014 use of strategic gas storage, \u2014 enforced use of stocks of alternative fuels (e.g. in accordance with Council Directive 2009/119/EC (1)), \u2014 enforced use of electricity generated from sources other than gas, \u2014 enforced increase of gas production levels, \u2014 enforced storage withdrawal; (b) demand-side measures: \u2014 various steps of compulsory demand reduction including: \u2014 enforced fuel switching, \u2014 enforced utilisation of interruptible contracts, where not fully utilised as part of market-based measures, \u2014 enforced firm load shedding. (1) Council Directive 2009/119/EC of 14 September 2009 imposing an obligation on Member States to maintain minimum stocks of crude oil and/or petroleum products (OJ L 265, 9.10.2009, p. 9). ANNEX IX Correlation table Regulation (EU) No 994/2010 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 Article 3 Article 6 Article 5 Article 8 Article 6 Article 9 Article 7 Article 4 Article 8 Article 5 Article 9 Article 10 Article 10 Article 10 Article 11 Article 11 Article 12 \u2014 Article 13 Article 13 Article 14 Article 12 Article 4 \u2014 Article 15 \u2014 Article 16 Article 14 Article 17 \u2014 Article 18 \u2014 Article 19 Article 16 Article 20 Article 15 Article 21 Article 17 Article 22 Annex I Annex II Article 7 Annex III Annex IV Annex I \u2014 Annex IV \u2014 Annex V \u2014 Annex VI \u2014 Annex VII Annex II \u2014 Annex III Annex VIII \u2014 Annex IX", "summary": "Gas supply security in the EU Gas supply security in the EU SUMMARY OF: Regulation 2017/1938 aiming to safeguard an uninterrupted supply of gas throughout the EU WHAT IS THE AIM OF THIS REGULATION? It aims to strengthen EU energy security by helping prevent potential supply disruptions \u2014 and to respond to them when they occur \u2014 to ensure that households and other vulnerable consumers are always supplied. The regulation forms part of the Energy Union package, which aims to make energy secure, affordable and sustainable through closer cooperation between EU countries. KEY POINTS Gas security of supply is the shared responsibility of natural gas companies, EU countries and the European Commission. The main elements of the regulation are: better cooperation and coordination between groups of EU countries in regional groups to assess common supply risks together and to develop and agree on joint preventive and emergency measures; introduction of the solidarity mechanism through which EU countries must help each other to always guarantee gas supply to the most vulnerable consumers \u2014 even in severe gas supply situations \u2014 under fair compensation conditions by the country receiving solidarity; improvement of transparency thanks to the obligation placed on gas companies to notify to their national authority their major long-term gas supply contracts that may be relevant for security of supply; the European Network of Transmission System Operators (ENTSOG) will carry out a 4-yearly EU-wide simulation of gas supply and infrastructure disruption scenarios; EU countries have specific obligations to the Energy Community, with the Commission coordinating the legal rules. Repeal The regulation repeals Regulation (EU) No 994/2010. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 1 November 2017. BACKGROUND For more information, see: Secure gas supplies (European Commission). MAIN DOCUMENT Regulation (EU) 2017/1938 of the European Parliament and of the Council of 25 October 2017 concerning measures to safeguard the security of gas supply and repealing Regulation (EU) No 994/2010 (OJ L 280, 28.10.2017, pp. 1-56) RELATED DOCUMENTS Communication from the Commission the European Parliament, the Council, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank \u2013 Framework Strategy for a Resilient Energy Union with a Forward-Looking Climate Change Policy (COM(2015) 80 final, 25.2.2015) Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (OJ L 115, 25.4.2013, pp. 39-75) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, pp. 94-136) last update 30.08.2018"}
{"article": "28.7.2017 EN Official Journal of the European Union L 198/1 REGULATION (EU) 2017/1369 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Union is committed to building an Energy Union with a forward looking climate policy. Energy efficiency is a crucial element of the Union's 2030 Climate and Energy Policy Framework and is key to moderating energy demand. (2) Energy labelling enables customers to make informed choices based on the energy consumption of energy-related products. Information on efficient and sustainable energy-related products makes a significant contribution to energy savings and to reducing energy bills, while at the same time promoting innovation and investments into the production of more energy efficient products. Improving the efficiency of energy-related products through informed customer choice and harmonising related requirements at Union level benefits also manufacturers, industry and the Union economy overall. (3) The Commission reviewed the effectiveness of Directive 2010/30/EU of the European Parliament and of the Council (3) and identified the need to update the energy labelling framework to improve its effectiveness. (4) It is appropriate to replace Directive 2010/30/EU by a Regulation which maintains essentially the same scope, but modifies and enhances some of its provisions in order to clarify and update their content, taking into account the technological progress for energy efficiency in products achieved over recent years. As the energy consumption of means of transport for persons or goods is directly and indirectly regulated by other Union law and policies, it is appropriate to continue to exempt them from the scope of this Regulation, including means of transport with a motor that stays in the same location during operation, such as elevators, escalators and conveyor belts. (5) It is appropriate to clarify that all products placed on the Union market for the first time, including second-hand imported products, should fall under the scope of this Regulation. However, products that are made available on the Union market for a second or additional time should not be included. (6) A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which preclude divergent transposition by Member States and thus ensures a higher degree of harmonisation across the Union. A harmonised regulatory framework at Union rather than at Member State level reduces costs for manufacturers, ensures a level playing field and ensures the free movement of goods across the internal market. (7) Moderating energy demand is recognised as a key action in the European Energy Security Strategy set out in the Commission Communication of 28 May 2014. The Energy Union Framework Strategy set out in the Commission Communication of 25 February 2015 further emphasised the energy efficiency first principle and the need to fully implement existing Union energy law. The Roadmap for the Energy Union Framework Strategy set out in that Communication provided for a review of the energy efficiency framework for products in 2015. This Regulation improves the legislative and enforcement framework for energy labelling. (8) Improving the efficiency of energy-related products through informed customer choice benefits the Union economy, reduces energy demand and saves customers money on energy bills, contributes to innovation and investment in energy efficiency, and enables industries which develop and produce the most energy efficient products to gain a competitive advantage. It also contributes to the achievement of the Union's 2020 and 2030 energy-efficiency targets, as well as to the Union's goals for the environment and climate change. Furthermore, it aims to have a positive impact on the environmental performance of the energy-related products and their parts, including use of resources other than energy. (9) This Regulation contributes to the development, recognition by customers and market uptake of energy smart products, which can be activated to interact with other appliances and systems, including the energy grid itself, in order to improve energy efficiency or the uptake of renewable energies, reduce energy consumption and foster innovation in Union industry. (10) The provision of accurate, relevant and comparable information on the specific energy consumption of energy-related products facilitates the customer's choice in favour of products which consume less energy and other essential resources during use. A standardised mandatory label for energy-related products is an effective means by which to provide potential customers with comparable information on the energy efficiency of energy-related products. The label should be supplemented by a product information sheet. The label should be easily recognisable, simple and concise. To that end, the existing dark green to red colour scale of the label should be retained as the basis for informing customers about the energy efficiency of products. In order for the label to be of real use for customers looking for energy and cost savings, the steps of the label scale should correspond to significant energy and cost savings for customers. For the majority of product groups, the label should, where appropriate, also indicate the absolute energy consumption in addition to the label scale, in order to allow customers to predict the direct impact of their choices on their energy bills. However, it is impossible to provide the same information with regard to energy-related products that do not themselves consume energy. (11) The classification using letters from A to G has been shown to be cost effective for customers. It is intended that its uniform application across product groups raises transparency and understanding among customers. In situations where because of ecodesign measures pursuant to Directive 2009/125/EC of the European Parliament and of the Council (4) products can no longer fall into class \u2018E\u2019, \u2018F\u2019 or \u2018G\u2019, those classes should nonetheless be shown on the label in grey. In exceptional and duly justified cases, such as reaching insufficient savings across the full spectrum of the seven classes, the label should be able to contain fewer classes than a regular A to G scale. In those cases the dark green to red colour scale of the label should be retained for the remaining classes and should apply only to new products that are placed on the market or put into service. (12) Where a supplier places a product on the market, each unit of the product should be accompanied by a label in paper form complying with the requirements of the relevant delegated act. The relevant delegated act should set out the most effective way of displaying the labels, taking into account the implications for customers, suppliers and dealers, and could provide that the label is printed on the packaging of the product. The dealer should display the label supplied together with the unit of the product in the position required by the relevant delegated act. The label displayed should be clearly visible and identifiable as the label belonging to the product in question, without the customer having to read the brand name and model number on the label, and should attract the attention of the customer browsing through the product displayed. (13) Without affecting the obligation of the supplier to provide a printed label together with each unit of a product, advances in digital technology could allow for the use of electronic labels in addition to the printed energy label. The dealer should also be able to download the product information sheet from the product database. (14) Where it is not feasible to display the energy label, such as in certain forms of distance selling, visual advertisements and technical promotional material, potential customers should be provided at least with the energy class of the product and the range of the efficiency classes available on the label. (15) Manufacturers respond to the energy label by developing and placing on the market ever more efficient products. In parallel, they tend to discontinue the production of less efficient products, stimulated to do so by Union law relating to ecodesign. This technological development leads to the majority of product models populating the highest classes of the energy label. Further product differentiation may be necessary to enable customers to compare products properly, leading to the need to rescale labels. This Regulation should therefore lay down detailed arrangements for rescaling in order to maximise legal certainty for suppliers and dealers. (16) For several labels established by delegated acts adopted pursuant to Directive 2010/30/EU, products are available only or mostly in the top classes. This reduces the effectiveness of the labels. The classes on existing labels, depending on the product group have varying scales, where the top class can be anything between classes A to A+++. As a result, when customers compare labels across different product groups, they could be led to believe that better energy classes exist for a particular label than those that are displayed. To avoid such potential confusion, it is appropriate to carry out, as a first step, an initial rescaling of existing labels, in order to ensure a homogeneous A to G scale for three categories of products pursuant to this Regulation. (17) Energy labelling of space and water heating products was introduced only recently and the rate of technological progress in those product groups is relatively slow. The current labelling scheme makes a clear distinction between conventional fossil fuel technologies that are at best class A, and technologies that use renewable energy, which are often significantly more expensive, for which classes A+, A++ and A+++ are reserved. Substantial energy savings can already be achieved by the most efficient fossil fuel technologies, which would make it appropriate to continue promoting them as class A. As the market for space and water heating products is likely to move slowly towards more renewable technologies, it is appropriate to rescale the energy labels for those products later. (18) Following initial rescaling, the frequency of further rescaling should be determined by reference to the percentage of products sold that are in the top classes. Further rescaling should take into account the speed of technological progress and the need to avoid over burdening suppliers and dealers, and, in particular, small businesses. Therefore, a timescale of approximately 10 years would be desirable for the frequency of rescaling. A newly rescaled label should leave the top class empty to encourage technological progress, provide for regulatory stability, limit the frequency of rescaling and enable ever more efficient products to be developed and recognised. In exceptional cases, where technology is expected to develop more rapidly, no products should fall within the top two classes at the moment of introduction of the newly rescaled label. (19) Before rescaling, the Commission should carry out an appropriate preparatory study. (20) When a label for a product group is rescaled, confusion on the part of customers should be avoided by replacing the labels on the affected products displayed in shops within a short timeframe, and by organising adequate consumer information campaigns clearly indicating that a new version of the label has been introduced. (21) In the case of a rescaled label, suppliers should provide both the existing and the rescaled labels to dealers for a certain period. The replacement of the existing labels on products on display, including on the internet, with the rescaled labels should take place as quickly as possible after the date of replacement specified in the delegated act on the rescaled label. Dealers should not display the rescaled labels before the date of replacement. (22) It is necessary to provide for a clear and proportionate distribution of obligations corresponding to the role of each operator in the supply and distribution process. Economic operators should be responsible for compliance in relation to their respective roles in the supply chain and should ensure that they make available on the market only products which comply with this Regulation and the delegated acts adopted pursuant thereto. (23) In order for customers to retain confidence in the energy label, other labels that mimic the energy label should not be allowed to be used for energy-related products and non-energy-related products. Where energy-related products are not covered by delegated acts, Member States should be able to maintain or introduce new national schemes for the labelling of such products. Additional labels, marks, symbols or inscriptions that are likely to mislead or confuse customers with respect to the consumption of energy for the product concerned should not be allowed for the same reason. Labels provided for pursuant to Union law, such as the labelling of tyres with respect to fuel efficiency and other environmental parameters, and additional labels such as the EU Energy Star and EU Ecolabel should not be considered to be misleading or confusing. (24) Increasingly, customers are offered software or firmware updates of their products after the products have been placed on the market and put into use. While such updates are typically intended to improve product performance, they may also impact the energy efficiency and other product parameters indicated on the energy label. If those changes are to the detriment of what is indicated on the label, customers should be informed about those changes and should be given the option of accepting or refusing the update. (25) In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 of the European Parliament and of the Council (5) apply to energy-related products. Given the principle of free movement of goods, it is imperative that Member States' market surveillance authorities cooperate with each other effectively. Such cooperation on energy labelling should be reinforced through support by the Commission of the Administrative Cooperation Groups (AdCos) on Ecodesign and Energy Labelling. (26) The Commission proposal for a new regulation on market surveillance of products integrates the provisions of Regulation (EC) No 765/2008, Directive 2001/95/EC of the European Parliament and of the Council (6) and several sector-specific Union harmonisation legislative acts. That proposal includes provisions on safeguard clauses contained in Decision No 768/2008/EC of the European Parliament and of the Council (7), which would apply to all Union harmonisation legislative acts. For so long as the new regulation is still under consideration by the co-legislators, it is appropriate to refer to Regulation (EC) No 765/2008 and to include safeguard clauses in this Regulation. (27) Market surveillance activities covered by Regulation (EC) No 765/2008 are not directed exclusively towards the protection of health and safety, but are also applicable to the enforcement of Union law which seek to safeguard other public interests, including energy efficiency. In line with the Commission Communication entitled \u201820 actions for safer and compliant products for Europe: a multi-annual action plan for the surveillance of products in the EU\u2019 of 13 February 2013, the Union general risk assessment methodology has been updated so that it covers all risks, including those relating to energy labelling. (28) Coherent and cost-effective market surveillance activity throughout the Union also requires well-structured, comprehensive archiving and sharing of all pertinent information among Member States on national activities in this context, including a reference to notifications required by this Regulation. The Information and Communication System on Market Surveillance (ICSMS) database established by the Commission is well-suited for the purpose of forming a complete database of market surveillance information, and its use should therefore be strongly encouraged. (29) In order to set up a useful tool for consumers, to allow for alternative ways for dealers to receive product information sheets, to facilitate the monitoring of compliance and to provide up-to-date market data for the regulatory process on revisions of product-specific labels and information sheets, the Commission should set up and maintain a product database consisting of a public and a compliance part, which should be accessible via an online portal. (30) Without prejudice to the Member States' market surveillance obligations and to suppliers' obligations to check product conformity, suppliers should make the required product compliance information available electronically in the product database. The information relevant for consumers and dealers should be made publicly available in the public part of the product database. That information should be made available as open data so as to give mobile application developers and other comparison tools the opportunity to use it. Easy direct access to the public part of the product database should be facilitated by user-oriented tools, such as a dynamic quick response code (QR code), included on the printed label. (31) The compliance part of the product database should be subject to strict data protection rules. The required specific parts of the technical documentation in the compliance part should be made available both to market surveillance authorities and to the Commission. Where some technical information is so sensitive that it would be inappropriate to include it in the category of technical documentation as detailed in delegated acts adopted pursuant to this Regulation, market surveillance authorities should retain the power to access that information when necessary in accordance with the duty of cooperation on suppliers or by way of additional parts of the technical documentation uploaded to the product database by suppliers on a voluntary basis. (32) In order for the product database to be of use as soon as possible, registration should be mandatory for all models the units of which are placed on the market as from the date of entry into force of this Regulation. For models, the units of which are placed on the market before the date of entry into force of this Regulation and which are no longer marketed, registration should be optional. An appropriate transitional period should be provided for the development of the database and to allow suppliers to comply with their registration obligation. When any changes with relevance for the label and the product information sheet are made to a product already on the market, the product should be considered to be a new model and the supplier should register it in the product database. The Commission, in cooperation with market surveillance authorities and suppliers, should pay special attention to the transitional process until the full implementation of the public and compliance parts of the product database. (33) The penalties applicable to infringements of the provisions of this Regulation and delegated acts adopted pursuant thereto should be effective, proportionate and dissuasive. (34) In order to promote energy efficiency, climate mitigation and environmental protection, Member States should be able to create incentives for the use of energy-efficient products. Member States are free to decide on the nature of such incentives. Such incentives should comply with Union State aid rules and should not constitute unjustifiable market barriers. This Regulation does not prejudice the outcome of any future State aid procedure that may be undertaken in accordance with Articles 107 and 108 of the Treaty on the Functioning of the European Union (TFEU) in respect of such incentives. (35) Energy consumption, performance and other information concerning the products covered by product-specific requirements under this Regulation should be measured by using reliable, accurate and reproducible methods that take into account the generally recognised state-of-the-art measurements and calculation methods. In the interests of the proper functioning of the internal market, standards should be harmonised at Union level. Such methods and standards should, to the extent possible, take into account the real-life usage of a given product, reflect average consumer behaviour and be robust in order to deter intentional and unintentional circumvention. Energy labels should reflect the comparative performance of the actual use of products, within the constraints due to the need of reliable and reproducible laboratory testing. Suppliers should therefore not be allowed to include software or hardware that automatically alters the performance of the product in test conditions. In the absence of published standards at the time of application of product-specific requirements, the Commission should publish, in the Official Journal of the European Union, transitional measurement and calculation methods in relation to those product-specific requirements. Once a reference to such a standard has been published, compliance with it should provide a presumption of conformity with measurement methods for those product-specific requirements adopted on the basis of this Regulation. (36) The Commission should provide a long-term working plan for the revision of labels for particular energy-related products including an indicative list of further energy-related products for which an energy label could be established. The working plan should be implemented starting with a technical, environmental and economic analysis of the product groups concerned. That analysis should also look at supplementary information including the possibility and cost of providing consumers with information on the performance of an energy-related product, such as its energy consumption, durability or environmental performance, in coherence with the objective to promote a circular economy. Such supplementary information should improve the intelligibility and effectiveness of the label towards consumers and should not lead to any negative impact on consumers. (37) Suppliers of products marketed in accordance with Directive 2010/30/EU before the date of entry into force of this Regulation should continue to be subject to the obligation to make available an electronic version of the technical documentation of the products concerned upon request of the market surveillance authorities. Appropriate transitional provisions should ensure legal certainty and continuity in this respect. (38) In addition, in order to ensure a seamless transition to this Regulation, the existing requirements laid down in delegated acts adopted pursuant to Article 10 of Directive 2010/30/EU and Commission Directive 96/60/EC (8) should continue to apply to the relevant product groups until they are repealed or replaced by delegated acts adopted pursuant to this Regulation. The application of those existing requirements is without prejudice to the application of the obligations under this Regulation. (39) In order to establish specific product groups of energy-related products in accordance with a set of specific criteria and in order to establish product-specific labels and information sheets, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making (9). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (40) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers for determining under the Union safeguard procedure whether a national measure is justified or not and for establishing detailed requirements concerning the operational details relating to the product database should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (10). (41) Since the objectives of this Regulation, namely to allow customers to choose more efficient products by supplying relevant information, cannot be sufficiently achieved by the Member States but can rather, by further developing the harmonised regulatory framework and ensuring a level playing field for manufacturers, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (42) This Regulation should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and the date of application of Directive 2010/30/EU. (43) Directive 2010/30/EU should therefore be repealed, HAVE ADOPTED THIS REGULATION: Article 1 Subject-matter and scope 1. This Regulation lays down a framework that applies to energy-related products (\u2018products\u2019) placed on the market or put into service. It provides for the labelling of those products and the provision of standard product information regarding energy efficiency, the consumption of energy and of other resources by products during use and supplementary information concerning products, thereby enabling customers to choose more efficient products in order to reduce their energy consumption. 2. This Regulation does not apply to: (a) second-hand products, unless they are imported from a third country; (b) means of transport for persons or goods. Article 2 Definitions For the purposes of this Regulation the following definitions apply: (1) \u2018energy-related product\u2019 or \u2018product\u2019 means a good or system with an impact on energy consumption during use which is placed on the market or put into service, including parts with an impact on energy consumption during use which are placed on the market or put into service for customers and that are intended to be incorporated into products; (2) \u2018product group\u2019 means a group of products which have the same main functionality; (3) \u2018system\u2019 means a combination of several goods which when put together perform a specific function in an expected environment and of which the energy efficiency can then be determined as a single entity; (4) \u2018model\u2019 means a version of a product of which all units share the same technical characteristics relevant for the label and the product information sheet and the same model identifier; (5) \u2018model identifier\u2019 means the code, usually alphanumeric, which distinguishes a specific product model from other models with the same trade mark or the same supplier's name; (6) \u2018equivalent model\u2019 means a model which has the same technical characteristics relevant for the label and the same product information sheet, but which is placed on the market or put into service by the same supplier as another model with a different model identifier; (7) \u2018making available on the market\u2019 means the supply of a product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (8) \u2018placing on the market\u2019 means the first making available of a product on the Union market; (9) \u2018putting into service\u2019 means the first use of a product for its intended purpose on the Union market; (10) \u2018manufacturer\u2019 means a natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark; (11) \u2018authorised representative\u2019 means a natural or legal person established in the Union who has received a written mandate from the manufacturer to act on its behalf in relation to specified tasks; (12) \u2018importer\u2019 means a natural or legal person established in the Union who places a product from a third country on the Union market; (13) \u2018dealer\u2019 means a retailer or other natural or legal person who offers for sale, hire, or hire purchase, or displays products to customers or installers in the course of a commercial activity, whether or not in return for payment; (14) \u2018supplier\u2019 means a manufacturer established in the Union, the authorised representative of a manufacturer who is not established in the Union, or an importer, who places a product on the Union market; (15) \u2018distance selling\u2019 means the offer for sale, hire or hire purchase by mail order, catalogue, internet, telemarketing or by any other method by which the potential customer cannot be expected to see the product displayed; (16) \u2018customer\u2019 means a natural or legal person who buys, hires or receives a product for own use whether or not acting for purposes which are outside its trade, business, craft or profession; (17) \u2018energy efficiency\u2019 means the ratio of output of performance, service, goods or energy to input of energy; (18) \u2018harmonised standard\u2019 means standard as defined in point (c) of Article 2(1) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council (11); (19) \u2018label\u2019 means a graphic diagram, either in printed or electronic form, including a closed scale using only letters from A to G, each letter representing a class and each class corresponding to energy savings, in seven different colours from dark green to red, in order to inform customers about energy efficiency and energy consumption; it includes rescaled labels and labels with fewer classes and colours in accordance with Article 11(10) and (11); (20) \u2018rescaling\u2019 means an exercise making the requirements for achieving the energy class on a label for a particular product group more stringent; (21) \u2018rescaled label\u2019 means a label for a particular product group that has undergone rescaling and is distinguishable from labels before rescaling while preserving a visual and perceptible coherence of all labels; (22) \u2018product information sheet\u2019 means a standard document containing information relating to a product, in printed or electronic form; (23) \u2018technical documentation\u2019 means documentation sufficient to enable market surveillance authorities to assess the accuracy of the label and the product information sheet of a product, including test reports or similar technical evidence; (24) \u2018supplementary information\u2019 means information, as specified in a delegated act, on the functional and environmental performance of a product; (25) \u2018product database\u2019 means a collection of data concerning products, which is arranged in a systematic manner and consists of a consumer-oriented public part, where information concerning individual product parameters is accessible by electronic means, an online portal for accessibility and a compliance part, with clearly specified accessibility and security requirements; (26) \u2018verification tolerance\u2019 means the maximum admissible deviation of the measurement and calculation results of the verification tests performed by, or on behalf of, market surveillance authorities, compared to the values of the declared or published parameters, reflecting deviation arising from interlaboratory variation. Article 3 General obligations of suppliers 1. The supplier shall ensure that products that are placed on the market are accompanied, for each individual unit, free of charge, with accurate printed labels and with product information sheets in accordance with this Regulation and the relevant delegated acts. As an alternative to supplying the product information sheet with the product, delegated acts referred to in point (h) of Article 16(3) may provide that it is sufficient for the supplier to enter the parameters of such product information sheet into the product database. In such a case, the supplier shall provide the product information sheet in printed form to the dealer on request. Delegated acts may provide that the label is printed on the packaging of the product. 2. The supplier shall deliver printed labels, including rescaled labels in accordance with Article 11(13), and product information sheets, to the dealer free of charge, promptly and in any event within five working days upon the dealer's request. 3. The supplier shall ensure the accuracy of the labels and product information sheets that it provides and shall produce technical documentation sufficient to enable the accuracy to be assessed. 4. Once a unit of a model is in service, the supplier shall request explicit consent from the customer regarding any changes intended to be introduced to the unit by means of updates that would be detrimental to the parameters of the energy efficiency label for that unit, as set out in the relevant delegated act. The supplier shall inform the customer of the objective of the update and of the changes in the parameters, including any change in the label class. For a period proportionate to the average lifespan of the product, the supplier shall give the customer the option of refusing the update without avoidable loss of functionality. 5. The supplier shall not place on the market products that have been designed so that a model's performance is automatically altered in test conditions with the objective of reaching a more favourable level for any of the parameters specified in the relevant delegated act or included in any of the documentation provided with the product. Article 4 Obligations of suppliers in relation to the product database 1. As from 1 January 2019, the supplier shall, before placing on the market a unit of a new model covered by a delegated act, enter in the public and compliance parts of the product database the information for that model, as set out in Annex I. 2. Where units of models covered by a delegated act are placed on the market between 1 August 2017 and 1 January 2019, the supplier shall, by 30 June 2019, enter in the product database the information set out in Annex I in relation to those models. Until data entry in the product database, the supplier shall make an electronic version of the technical documentation available for inspection within 10 days of a request received from market surveillance authorities or the Commission. 3. The supplier may enter in the product database the information for models, as set out in Annex I, the units of which were exclusively placed on the market before 1 August 2017. 4. A product for which changes are made that are relevant for the label or the product information sheet shall be considered to be a new model. The supplier shall indicate in the database when it no longer places on the market units of a model. 5. The obligations referred to in paragraphs 1 and 2 of this Article shall not apply to packages of heaters referred to in Commission Delegated Regulations (EU) No 811/2013 (12), (EU) No 812/2013 (13) and (EU) 2015/1187 (14), where the provision of labels for those packages is the sole responsibility of the dealer. 6. After the final unit of a model has been placed on the market, the supplier shall keep the information concerning that model in the compliance part of the product database for a period of 15 years. Where appropriate in relation to the average life span of a product, a shorter retention period may be provided for pursuant to point (q) of Article 16(3). The information in the public part of the database shall not be deleted. Article 5 Obligations of dealers 1. The dealer shall: (a) display, in a visible manner, including for online distance selling, the label provided by the supplier or made available in accordance with paragraph 2 for units of a model covered by the relevant delegated act; and (b) make available to customers the product information sheet, including, upon request, in physical form at the point of sale. 2. Where, notwithstanding Article 3(1), the dealer does not have a label, it shall request one from the supplier in accordance with Article 3(2). 3. Where, notwithstanding Article 3(1), the dealer does not have a product information sheet, it shall request one from the supplier in accordance with Article 3(2); or, if it chooses to do so, print or download one for electronic display from the product database, if those functions are available for the relevant product. Article 6 Other obligations of suppliers and dealers The supplier and the dealer shall: (a) make reference to the energy efficiency class of the product and the range of the efficiency classes available on the label in visual advertisements or technical promotional material for a specific model in accordance with the relevant delegated act; (b) cooperate with market surveillance authorities and take immediate action to remedy any case of non-compliance with the requirements set out in this Regulation and the relevant delegated acts, which falls under their responsibility, at their own initiative or when required to do so by market surveillance authorities; (c) for products covered by delegated acts, not provide or display other labels, marks, symbols or inscriptions which do not comply with the requirements of this Regulation and the relevant delegated acts, if doing so would be likely to mislead or confuse customers with respect to the consumption of energy or other resources during use; (d) for products not covered by delegated acts, not supply or display labels which mimic the labels provided for under this Regulation and the relevant delegated acts; (e) for non-energy related products, not supply or display labels which mimic the labels provided for in this Regulation or in delegated acts. Point (d) in the first subparagraph shall not affect labels provided for in national law, unless those labels are provided for in delegated acts. Article 7 Obligations of Member States 1. Member States shall not impede the placing on the market or putting into service, within their territories, of products which comply with this Regulation and the relevant delegated acts. 2. Where Member States provide incentives for a product specified in a delegated act, those incentives shall aim at the highest two significantly populated classes of energy efficiency, or at higher classes as laid down in that delegated act. 3. Member States shall ensure that the introduction of labels and rescaling of labels is accompanied by educational and promotional information campaigns on energy labelling, if appropriate in cooperation with suppliers and dealers. The Commission shall support cooperation and the exchange of best practices in relation to those campaigns, including through the recommendation of common key messages. 4. Member States shall lay down the rules on penalties and enforcement mechanisms applicable to infringements of this Regulation and the delegated acts, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Rules which fulfil the requirements of Article 15 of Directive 2010/30/EU shall be considered to fulfil the requirements of this paragraph as regards penalties. Member States shall, by 1 August 2017, notify the Commission of the rules referred to in the first subparagraph that have not previously been notified to the Commission, and shall notify the Commission, without delay, of any subsequent amendment affecting them. Article 8 Union market surveillance and control of products entering the Union market 1. Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to products covered by this Regulation and by the relevant delegated acts. 2. The Commission shall encourage and support cooperation and the exchange of information on market surveillance relating to the labelling of products between national authorities of the Member States that are responsible for market surveillance or in charge of the control of products entering the Union market and between them and the Commission, inter alia, by involving more closely the AdCos on Ecodesign and Energy Labelling. Such exchanges of information shall also be conducted when test results indicate that the product complies with this Regulation and the relevant delegated act. 3. Member States' general market surveillance programmes or sector specific programmes established pursuant to Article 18 of Regulation (EC) No 765/2008 shall include actions to ensure the effective enforcement of this Regulation. 4. The Commission shall, in cooperation with the AdCos on Ecodesign and Energy Labelling, elaborate guidelines for the enforcement of this Regulation, in particular as regards best practices for product testing and the sharing of information between national market surveillance authorities and the Commission. 5. Market surveillance authorities shall have the right to recover from the supplier the costs of document inspection and physical product testing in case of non-compliance with this Regulation or the relevant delegated acts. Article 9 Procedure at national level for dealing with products presenting a risk 1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a product covered by this Regulation presents a risk to aspects of public interest protection covered by this Regulation, such as environmental and consumer protection aspects, they shall carry out an evaluation in relation to the product concerned covering all energy labelling requirements relevant to the risk and laid down in this Regulation or in the relevant delegated act. Suppliers and dealers shall cooperate as necessary with the market surveillance authorities for the purpose of that evaluation. 2. Where, in the course of the evaluation referred to in paragraph 1, the market surveillance authorities find that the product does not comply with the requirements laid down in this Regulation or in the relevant delegated act, they shall without delay require the supplier, or where appropriate, the dealer, to take all appropriate corrective action to bring the product into compliance with those requirements, where appropriate to withdraw the product from the market, or where appropriate, to recall it within a reasonable period, commensurate with the nature of the risk as they may prescribe. Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in this paragraph. 3. Where the market surveillance authorities consider that a case of non-compliance as referred to in paragraph 2 is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the action which they have required the supplier or dealer to take. 4. The supplier or, where appropriate, the dealer shall ensure that all appropriate corrective or restrictive action in accordance with paragraph 2 is taken in respect of all the products concerned that it has made available on the market throughout the Union. 5. Where the supplier or, where appropriate, the dealer does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the availability of the product on their national market, to withdraw the product from that market, or to recall it. 6. The market surveillance authorities shall inform the Commission and the other Member States without delay of the measures taken pursuant to paragraph 5. That information shall include all available details, in particular: (a) the data necessary for the identification of the non-compliant product; (b) the origin of the product; (c) the nature of the non-compliance alleged and the risk involved; (d) the nature and duration of the national measures taken and the arguments put forward by the supplier or, where appropriate, the dealer. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either failure of the product to meet requirements relating to aspects of public interest protection laid down in this Regulation or shortcomings in the harmonised standards referred to in Article 13 conferring a presumption of conformity. 7. Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the notified national measure, of their objections. 8. Where, within 60 days of receipt of the information referred to in paragraph 6, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed to be justified. 9. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the product from their market, are taken in respect of the product concerned, without delay. Article 10 Union safeguard procedure 1. Where, on completion of the procedure set out in Article 9(4) and (5), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union law, the Commission shall, without delay, consult the Member State and the supplier or, where appropriate, the dealer and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide by means of an implementing act whether the national measure is justified or not and may suggest an appropriate alternative measure. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 18(2). 2. The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the supplier or dealer concerned. 3. If the national measure is considered to be justified, all Member States shall take the measures necessary to ensure that the non-compliant product is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered to be unjustified, the Member State concerned shall withdraw the measure. 4. Where the national measure is considered to be justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in Article 9(6) of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012. 5. Corrective or restrictive measures pursuant to Article 9(2), (4), (5) or (9), or Article 10(3) shall be extended to all units of a non-compliant model and of its equivalent models, except those units for which the supplier demonstrates that they are compliant. Article 11 Procedure for the introduction and rescaling of labels 1. As regards the product groups referred to in paragraphs 4 and 5, the Commission shall rescale labels which were in force on 1 August 2017 subject to paragraphs 4 and 5 and paragraphs 8 to 12. By way of derogation from the requirement of achieving significant energy and cost savings set out in point (b) of Article 16(3), where the rescaling cannot achieve such savings, it shall ensure at least a homogenous A to G scale. 2. Where a label does not exist for a product group on 1 August 2017, the Commission may, subject to paragraphs 8 to 12, introduce labels. 3. The Commission may further rescale labels which have been rescaled in accordance with paragraph 1 or introduced in accordance with paragraph 2 where the conditions under point (a) or (b) of paragraph 6 are met, and subject to paragraphs 8 to 12. 4. In order to ensure a homogenous A to G scale, the Commission shall adopt, by 2 August 2023, delegated acts pursuant to Article 16 of this Regulation in order to supplement this Regulation by introducing A to G rescaled labels for product groups covered by delegated acts adopted pursuant to Directive 2010/30/EU, with the aim of displaying the rescaled label both in shops and online, 18 months after the date of entry into force of the delegated acts adopted pursuant to this Regulation. When determining the order of product groups to be rescaled, the Commission shall take into account the proportion of products in the highest classes. 5. By way of derogation from paragraph 4, the Commission shall: (a) present reviews for the product groups covered by Delegated Regulations (EU) No 811/2013, (EU) No 812/2013 and (EU) 2015/1187 by 2 August 2025 with a view to rescaling them, and, where appropriate, shall, by 2 August 2026, adopt delegated acts pursuant to Article 16 of this Regulation in order to supplement this Regulation by introducing A to G rescaled labels. In any event, the delegated acts introducing A to G rescaled labels shall be adopted no later than 2 August 2030. (b) adopt, by 2 November 2018, delegated acts pursuant to Article 16 of this Regulation in order to supplement this Regulation by introducing A to G rescaled labels for product groups covered by Commission Delegated Regulations (EU) No 1059/2010 (15), (EU) No 1060/2010 (16), (EU) No 1061/2010 (17), (EU) No 1062/2010 (18) and (EU) No 874/2012 (19) and Directive 96/60/EC, with the aim of displaying the rescaled label both in shops and online, 12 months after their date of entry into force. 6. As regards the products for which the Commission may further rescale the labels in accordance with paragraph 3, the Commission shall review the label with a view to rescaling if it estimates that: (a) 30 % of the units of models belonging to a product group sold within the Union market fall into the top energy efficiency class A and further technological development can be expected; or (b) 50 % of the units of models belonging to a product group sold within the Union market fall into the top two energy efficiency classes A and B and further technological development can be expected. 7. The Commission shall carry out a review study if it has estimated that the conditions of point (a) or (b) of paragraph 6 are met. If, for a specific product group, those conditions are not met within eight years after the date of entry into force of the relevant delegated act, the Commission shall identify which barriers, if any, have prevented the label from fulfilling its role. In the case of new labels it shall carry out a preparatory study based on the indicative list of product groups set out in the working plan. The Commission shall finalise its review study, present the results and, where appropriate, a draft delegated act to the Consultation Forum within 36 months of the Commission estimating that the conditions referred to in point (a) or (b) of paragraph 6 are met. The Consultation Forum shall discuss the estimate and the review study. 8. Where a label is introduced or rescaled, the Commission shall ensure that no products are expected to fall into energy class A at the moment of the introduction of the label and the estimated time within which a majority of models falls into that class is at least 10 years later. 9. By way of derogation from paragraph 8, where technology is expected to develop more rapidly, requirements shall be laid down so that no products are expected to fall into energy classes A and B at the moment of the introduction of the label. 10. Where, for a given product group, models belonging to energy class E, F or G are no longer allowed to be placed on the market or put into service because of an Ecodesign implementing measure adopted pursuant to Directive 2009/125/EC, the class or classes in question shall be shown on the label in grey as specified in the relevant delegated act. The label with the grey classes shall apply only to new product units placed on the market or put into service. 11. Where, for technical reasons, it is impossible to define seven energy classes that correspond to significant energy and cost savings from a customer's perspective, the label may, by way of derogation from point (14) of Article 2, contain fewer classes. In such cases, the dark green to red spectrum of the label shall be retained. 12. The Commission shall exercise the powers and obligations conferred on it by this Article in accordance with Article 16. 13. Where, pursuant to paragraph 1 or 3, a label is rescaled: (a) the supplier shall, when placing a product on the market, provide both the existing and the rescaled labels and the product information sheets to the dealer for a period beginning four months before the date specified in the relevant delegated act for starting the display of the rescaled label. By way of derogation from the first subparagraph of this point, if the existing and the rescaled label require different testing of the model, the supplier may choose not to supply the existing label with units of models placed on the market or put into service during the four-month period before the date specified in the relevant delegated act for starting the display of the rescaled label if no units belonging to the same model or equivalent models were placed on the market or put into service before the start of the four-month period. In that case, the dealer shall not offer those units for sale before that date. The supplier shall notify the dealer concerned of that consequence as soon as possible, including when it includes such units in its offers to dealers. (b) the supplier shall, for products placed on the market or put into service before the four-month period, deliver the rescaled label on request from the dealer in accordance with Article 3(2) as from the start of that period. For such products, the dealer shall obtain a rescaled label in accordance with Article 5(2). By way of derogation from the first subparagraph of this point: (i) a dealer who is unable to obtain a rescaled label in accordance with the first subparagraph of this point for units already in its stock because the supplier has ceased its activities shall be permitted to sell those units exclusively with the non-rescaled label until nine months after the date specified in the relevant delegated act for starting the display of the rescaled label; or (ii) if the non-rescaled and the rescaled label require different testing of the model, the supplier is exempt from the obligation to supply a rescaled label for units placed on the market or put into service before the four month period, if no units belonging to same model or equivalent models are placed on the market or put into service after the start of the four-month period. In that case, the dealer shall be permitted to sell those units exclusively with the non-rescaled label until nine months after the date specified in the relevant delegated act for starting the display of the rescaled label. (c) the dealer shall replace the existing labels on products on display, both in shops and online, with the rescaled labels within 14 working days after the date specified in the relevant delegated act for starting the display of the rescaled label. The dealer shall not display the rescaled labels before that date. By way of derogation from points (a), (b) and (c) of this paragraph, delegated acts referred to in point (e) of Article 16(3) may provide for specific rules for energy labels printed on the packaging. Article 12 Product database 1. The Commission shall establish and maintain a product database consisting of a public part, a compliance part and an online portal giving access to those two parts. The product database shall not replace or modify the responsibilities of the market surveillance authorities. 2. The product database shall serve the following purposes: (a) to support market surveillance authorities in carrying out their tasks under this Regulation and the relevant delegated acts, including enforcement thereof; (b) to provide the public with information about products placed on the market and their energy labels, and product information sheets; (c) to provide the Commission with up-to-date energy efficiency information for products for reviewing energy labels; 3. The public part of the database and the online portal shall contain the information set out in points 1 and 2 of Annex I respectively which shall be made publicly available. The public part of the database shall meet the criteria in paragraph 7 of this Article, and the functional criteria set out in point 4 of Annex I. 4. The compliance part of the product database shall be accessible only to market surveillance authorities and to the Commission and shall contain the information set out in point 3 of Annex I, including the specific parts of the technical documentation as referred to in paragraph 5 of this Article. The compliance part shall meet the criteria in paragraphs 7 and 8 of this Article, and the functional criteria set out in point 4 of Annex I. 5. The mandatory specific parts of the technical documentation that the supplier shall enter into the database shall cover only: (a) a general description of the model, sufficient for it to be unequivocally and easily identified; (b) references to the harmonised standards applied or other measurement standards used; (c) specific precautions that shall be taken when the model is assembled, installed, maintained or tested; (d) the measured technical parameters of the model; (e) the calculations performed with the measured parameters; (f) testing conditions if not described sufficiently in point (b). In addition, the supplier may upload additional parts of the technical documentation on a voluntary basis into the database. 6. When data other than those specified in paragraph 5 or not available in the public part of the database would become necessary for market surveillance authorities and/or the Commission for carrying out their tasks under this Regulation, they shall be able to obtain them from the supplier on request. 7. The product database shall be established in accordance with the following criteria: (a) minimising the administrative burden for the supplier and other database users; (b) user-friendliness and cost-effectiveness; and (c) automatic avoidance of redundant registration. 8. The compliance part of the database shall be established in accordance with the following criteria: (a) protection from unintended use and the safeguarding of confidential information by way of strict security arrangements; (b) access rights based on the need-to-know principle; (c) processing of personal data in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, as applicable; (d) limitation of data access in scope to prevent copying larger data sets; (e) traceability of data access for the supplier with regard to its technical documentation. 9. The data in the compliance part of the database shall be treated in accordance with Commission Decision (EU, Euratom) 2015/443 (20). In particular, the specific cyber-security arrangements of Commission Decision (EU, Euratom) 2017/46 (21) and its implementing rules shall apply. The confidentiality level shall reflect the consequential harm resulting from disclosure of the data to unauthorised persons. 10. The supplier shall have access and editing rights to the information it enters in the product database pursuant to Article 4(1) and (2). A record of changes shall be kept for market surveillance purposes, keeping track of the dates of any editing. 11. Customers using the public part of the product database shall be able to easily identify the best energy class populated for each product group, allowing them to compare model characteristics and to choose the most energy efficient products. 12. The Commission shall be empowered to specify, by means of implementing acts, the operational details of the product database. After consulting the Consultation Forum provided for in Article 14, those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2). Article 13 Harmonised standards 1. After the adoption of a delegated act pursuant to Article 16 of this Regulation setting specific labelling requirements the Commission shall, in accordance with Regulation (EU) No 1025/2012, publish references to the harmonised standards that satisfy the relevant measurement and calculation requirements of the delegated act in the Official Journal of the European Union. 2. Where such harmonised standards are applied during the conformity assessment of a product, the model shall be presumed to be in conformity with the relevant measurement and calculation requirements of the delegated act. 3. Harmonised standards shall aim to simulate real-life usage as far as possible while maintaining a standard test method. Test methods shall furthermore take into account the associated costs for industry and small and medium sized enterprises (SMEs). 4. Measurement and calculation methods included in the harmonised standards shall be reliable, accurate and reproducible, and aligned with the requirements of Article 3(4) and (5). Article 14 Consultation Forum 1. In the conduct of its activities under this Regulation the Commission shall ensure, in respect of each delegated act adopted pursuant to Article 16 and each implementing act adopted pursuant to Article 12(12) of this Regulation, a balanced participation of Member States' representatives and interested parties concerned with the product group in question, such as industry, including SMEs and craft industry, trade unions, traders, retailers, importers, environmental protection groups and consumer organisations. For this purpose, the Commission shall establish a Consultation Forum in which these parties shall meet. The Consultation Forum shall be combined with the Consultation Forum referred to in Article 18 of Directive 2009/125/EC. 2. Where appropriate, when preparing delegated acts, the Commission shall test the design and content of the labels for specific product groups with representative groups of Union customers to ensure their clear understanding of the labels. Article 15 Working plan The Commission shall, after consulting the Consultation Forum referred to in Article 14, establish a long-term working plan which shall be made publicly available. The working plan shall set out an indicative list of product groups which are considered to be priorities for the adoption of delegated acts. The working plan shall also set out plans for the revision and rescaling of labels for product groups in accordance with Article 11(4) and (5), with the exception of the rescaling of labels which were in force at 1 August 2017 for which the rescaling is provided for in Article 11 of this Regulation. The Commission shall update the working plan periodically after consulting the Consultation Forum. The working plan may be combined with the working plan required by Article 16 of Directive 2009/125/EC and shall be reviewed every three years. The Commission shall inform the European Parliament and the Council annually of the progress made in the implementation of the working plan. Article 16 Delegated Acts 1. The Commission is empowered to adopt delegated acts in accordance with Article 17 in order to supplement this Regulation by establishing detailed requirements relating to labels for specific product groups. 2. The delegated acts referred to in paragraph 1 shall specify product groups which satisfy the following criteria: (a) according to the most recently available figures and considering the quantities placed on the Union market, the product group shall have significant potential for saving energy and where relevant, other resources; (b) within the product group, models with equivalent functionality shall differ significantly in the relevant performance levels; (c) there shall be no significant negative impact as regards the affordability and the life cycle cost of the product group; (d) the introduction of energy labelling requirements for a product group shall not have a significant negative impact on the functionality of the product during use; 3. Delegated acts relating to specific product groups shall specify, in particular: (a) the definition of the specific product group falling under the definition of \u2018energy-related product\u2019 set out in point 1 of Article 2 which is to be covered by the detailed labelling requirements; (b) the design and content of the label, including a scale showing consumption of energy consisting of A to G, which as far as possible shall have uniform design characteristics across product groups and shall in all cases be clear and legible. The A to G steps of the classification shall correspond to significant energy and cost savings and appropriate product differentiation from the customer's perspective. It shall also specify how the A to G steps of the classification, and where applicable energy consumption is displayed in a prominent position on the label; (c) where appropriate, the use of other resources and supplementary information concerning the product, in which case the label shall emphasise the energy efficiency of the product. Supplementary information shall be unambiguous and with no negative impact on the clear intelligibility and effectiveness of the label as a whole towards customers. It shall be based on data relating to physical product characteristics that are measurable and verifiable by market surveillance authorities; (d) where appropriate, the inclusion of a reference in the label allowing customers to identify products that are energy smart, that is to say, capable of automatically changing and optimising their consumption patterns in response to external stimuli (such as signals from or via a central home energy managing system, price signals, direct control signals, local measurement) or capable of delivering other services which increase energy efficiency and the up-take of renewable energy, with the aim to improve the environmental impact of energy use over the whole energy system; (e) the locations where the label shall be displayed, such as attached to the product unit where no damage is caused to it, printed on the packaging, provided in electronic format or displayed online, taking into account the requirements of Article 3(1), and the implications for customers, suppliers and dealers; (f) where appropriate, electronic means for labelling products; (g) the manner in which the label and product information sheet are to be provided in the case of distance selling; (h) the required contents and, where appropriate, the format and other details concerning the product information sheet and the technical documentation, including the possibility to enter the parameters of the product information sheet into the database in accordance with Article 3(1); (i) the verification tolerances to be used by Member States when verifying compliance with the requirements; (j) how the energy class and the range of the efficiency classes available on the label shall be included in visual advertisements and technical promotional material, including legibility and visibility; (k) the measurement and calculation methods referred to in Article 13, to be used to determine label and product information sheet information, including the definition of the energy efficiency index (EEI), or equivalent parameter; (l) whether for larger appliances a higher level of energy efficiency is required to reach a given energy class; (m) the format of any additional references on the label allowing customers to access through electronic means more detailed information on the product performance included in the product information sheet. The format of those references may take the form of a website address, a dynamic quickresponse code (QR code), a link on online labels or any other appropriate consumer-oriented means; (n) how, where appropriate energy classes describing the product's energy consumption during use should be shown on the product's interactive display; (o) the date for the evaluation and possible consequent revision of the delegated act; (p) where appropriate, differences in energy performances in different climatic regions; (q) as regards the requirement of keeping information in the compliance part of the database in Article 4(6), a retention period of less than 15 years, where appropriate in relation to the average lifespan of the product. 4. The Commission shall adopt a separate delegated act for each specific product group. When the Commission decides on the timing for the adoption of the delegated act for a specific product group, it shall not delay the adoption on grounds related to the adoption of a delegated act concerning another specific product group, unless exceptional circumstances warrant otherwise. 5. The Commission shall keep an updated inventory of all relevant delegated acts, as well as of the measures developing Directive 2009/125/EC, including complete references to all relevant harmonised standards. Article 17 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 11(4) and (5) and Article 16 shall be conferred on the Commission for a period of six years from 1 August 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the six-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 11(4) and (5) and Article 16 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. The consultation of Member States' experts shall take place after the consultation pursuant to Article 14. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 11(4) and (5) and Article 16 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or of the Council. Article 18 Committee procedure 1. The Commission shall be assisted by the committee established by Article 19 of Directive 2009/125/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 19 Evaluation and report By 2 August 2025, the Commission shall assess the implementation of this Regulation and submit a report to the European Parliament and to the Council. That report shall assess how effectively this Regulation and the delegated and implementing acts adopted pursuant thereto have allowed customers to choose more efficient products, taking into account its impacts on business, energy consumption, greenhouse gas emissions, market surveillance activities, and the cost to establish and maintain the database. Article 20 Repeal and transitional measures 1. Directive 2010/30/EU is repealed with effect from 1 August 2017. 2. References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex II. 3. For models, the units of which were placed on the market or put into service in accordance with Directive 2010/30/EU before 1 August 2017, the supplier shall, for a period ending five years after the final unit was manufactured, make an electronic version of the technical documentation available for inspection within 10 days of a request received from market surveillance authorities or the Commission. 4. Delegated acts adopted pursuant to Article 10 of Directive 2010/30/EU and Directive 96/60/EC shall remain in force until they are repealed by a delegated act adopted pursuant to Article 16 of this Regulation covering the relevant product group. Obligations under this Regulation shall apply in relation to product groups covered by delegated acts adopted pursuant to Article 10 of Directive 2010/30/EU and by Directive 96/60/EC. 5. With regard to product groups already covered by delegated acts adopted pursuant to Article 10 of Directive 2010/30/EU, or by Directive 96/60/EC, where the Commission adopts delegated acts pursuant to Article 16 of this Regulation, the energy efficiency classification established by Directive 2010/30/EU may, by way of derogation from point (b) of Article 16(3) of this Regulation, continue to apply until the date on which the delegated acts introducing rescaled labels pursuant to Article 11 of this Regulation become applicable. Article 21 Entry into force and application This Regulation shall enter into force on the fourth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 August 2017. By way of derogation from the second paragraph, Article 4 concerning the obligations of suppliers in relation to the product database shall apply from 1 January 2019. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 4 July 2017. For the European Parliament The President A. TAJANI For the Council The President M. MAASIKAS (1) OJ C 82, 3.3.2016, p. 6. (2) Position of the European Parliament of 13 June 2017 (not yet published in the Official Journal) and decision of the Council of 26 June 2017. (3) Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010 on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products (OJ L 153, 18.6.2010, p. 1). (4) Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10). (5) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (6) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). (7) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). (8) Commission Directive 96/60/EC of 19 September 1996 implementing Council Directive 92/75/EEC with regard to energy labelling of household combined washer-driers (OJ L 266, 18.10.1996, p. 1). (9) OJ L 123, 12.5.2016, p. 1. (10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (11) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (12) Commission Delegated Regulation (EU) No 811/2013 of 18 February 2013 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to the energy labelling of space heaters, combination heaters, packages of space heater, temperature control and solar device and packages of combination heater, temperature control and solar device (OJ L 239, 6.9.2013, p. 1). (13) Commission Delegated Regulation (EU) No 812/2013 of 18 February 2013 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to the energy labelling of water heaters, hot water storage tanks and packages of water heater and solar device (OJ L 239, 6.9.2013, p. 83). (14) Commission Delegated Regulation (EU) 2015/1187 of 27 April 2015 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of solid fuel boilers and packages of a solid fuel boiler, supplementary heaters, temperature controls and solar devices (OJ L 193, 21.7.2015, p. 43). (15) Commission Delegated Regulation (EU) No 1059/2010 of 28 September 2010 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of household dishwashers (OJ L 314, 30.11.2010, p. 1). (16) Commission Delegated Regulation (EU) No 1060/2010 of 28 September 2010 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of household refrigerating appliances (OJ L 314, 30.11.2010, p. 17). (17) Commission Delegated Regulation (EU) No 1061/2010 of 28 September 2010 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of household washing machines (OJ L 314, 30.11.2010, p. 47). (18) Commission Delegated Regulation (EU) No 1062/2010 of 28 September 2010 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of televisions (OJ L 314, 30.11.2010, p. 64). (19) Commission Delegated Regulation (EU) No 874/2012 of 12 July 2012 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of electrical lamps and luminaires (OJ L 258, 26.9.2012, p. 1). (20) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). (21) Commission Decision (EU, Euratom) 2017/46 of 10 January 2017 on the security of communication and information systems in the European Commission (OJ L 6, 11.1.2017, p. 40). ANNEX I INFORMATION TO BE ENTERED IN THE PRODUCT DATABASE AND FUNCTIONAL CRITERIA FOR THE PUBLIC PART OF THE DATABASE 1. Information to be entered in the public part of the database by the supplier: (a) the name or trademark, address, contact details and other legal identification of the supplier; (b) the model identifier; (c) the label in electronic format; (d) the energy efficiency class(es) and other parameters of the label; (e) the parameters of the product information sheet in electronic format. 2. Information to be entered in the online portal by the Commission: (a) contact details of Member State market surveillance authorities; (b) working-plan pursuant to Article 15; (c) minutes of the Consultation Forum; (d) an inventory of delegated and implementing acts, transitional measurement and calculation methods and applicable harmonised standards. 3. Information to be entered in the compliance part of the database by the supplier: (a) the model identifier of all equivalent models already placed on the market; (b) the technical documentation as specified in Article 12(5). The Commission shall provide a link to the Information and Communication System on Market Surveillance (ICSMS), which includes the outcome of compliance checks performed by Member States and provisional measures adopted. 4. Functional criteria for the public part of the product database: (a) each product model shall be retrievable as an individual record; (b) it shall generate a single viewable, downloadable and printable file of the energy label of each model, as well as the linguistic versions of the complete product information sheet, in all official languages of the Union; (c) the information shall be machine readable, sortable and searchable, respecting open standards for third party use, free of charge; (d) an online helpdesk or contact point for the supplier shall be established and maintained, clearly referenced on the portal. ANNEX II CORRELATION TABLE Directive 2010/30/EU This Regulation Article 1(1) Article 1(1) Article 1(2) \u2014 Article 1(3)(a) and (b) Article 1(2)(a) and (b) Article 1(3)(c) \u2014 Article 2 Article 2 Article 2(a) Article 2, point 1 Article 2(b) Article 2, point 22 Article 2(c) \u2014 Article 2(d) \u2014 Article 2(e) \u2014 Article 2(f) \u2014 Article 2(g) Article 2, point 13 Article 2(h) Article 2, point 14 Article 2(i) Article 2, point 8 Article 2(j) Article 2, point 9 Article 2(k) \u2014 Article 3 Article 7 Article 3(1)(a) Article 7(3) Article 3(1)(b) Article 6(c) Article 3(1)(c) Article 7(3) Article 3(1)(d) Article 8(2) Article 3(2) Article 6(b) and Article 9 Article 3(3) Article 8(1) Article 3(4) \u2014 Article 4(a) Article 5 Article 4(b) \u2014 Article 4(c) Article 6(a) Article 4(d) Article 6(a) Article 5 Article 3(1) and Article 6 Article 5(a) Article 3(1)(a) Article 5(b), points (i), (ii), (iii) and (iv) Article 4(6) and Annex I Article 5(c) Article 4(6) Article 5(d) Article 3(1) Article 5(d), second subparagraph Article 3(1) Article 5(e) Article 3(1) Article 5(f) \u2014 Article 5(g) Article 3(1) Article 5(h) \u2014 Article 6 Article 5(1) and Article 6 Article 6(a) Article 5(1)(a) Article 6(b) Article 5(1)(a) Article 7 Article 16(3)(e) and (g) Article 8(1) Article 7(1) Article 8(2) \u2014 Article 9(3) Article 7(2) Article 9(4) \u2014 Article 10(1) Article 16 Article 10(1), second paragraph Article 16(2) Article 10(1), third paragraph \u2014 Article 10(1), fourth paragraph Article 16(3)(c) Article 10(2)(a) Article 16(2)(a) Article 10(2)(b) Article 16(2)(b) Article 10(2)(c) \u2014 Article 10(3)(a) \u2014 Article 10(3)(b) \u2014 Article 10(3)(c) Article 14 Article 10(3)(d) \u2014 Article 10(4)(a) Article 16(3)(a) Article 10(4)(b) Article 16(3)(k) Article 10(4)(c) Article 16(3)(h) Article 10(4)(d) Article 16(3)(b) Article 10(4)(d), second paragraph \u2014 Article 10(4)(d), third paragraph Article 16(3)(b) Article 10(4)(d), fourth paragraph Article 11(3) Article 10(4)(d), fifth paragraph Article 11 Article 10(4)(e) Article 16(3)(e) Article 10(4)(f) Article 16(3)(h) Article 10(4)(g) Article 16(3)(j) Article 10(4)(h) Article 11(3) Article 10(4)(i) Article 16(3)(i) Article 10(4)(j) Article 16(3)(o) Article 11(1) Article 17(2) Article 11(2) Article 17(5) Article 11(3) Article 17(1) Article 12(1) Article 17(3) Article 12(2) \u2014 Article 12(3) Article 17(3) Article 13 Article 17(6) Article 14 Article 19 Article 15 Article 7(4) Article 16 \u2014 Article 17 Article 20 Article 18 Article 21 Article 19 Article 21 Annex I \u2014 \u2014 Annex I Annex II Annex II", "summary": "Energy consumption: Framework for labelling rules Energy consumption: Framework for labelling rules SUMMARY OF: Regulation (EU) 2017/1369 on energy labelling WHAT IS THE AIM OF THIS REGULATION? It sets out the basis for labelling energy-related products, providing standard information about energy efficiency \u2014 as well as the consumption of energy and other resources \u2014 to help consumers in purchase decisions. It does not cover second-hand products, unless they are imported from outside the EU, or means of transport. It repeals Directive 2010/30/EU. KEY POINTS All energy-related products will display labels on a new, updated and clearer scale from A (most efficient) to G (least efficient). This system will replace the previous system of A+++ to G labels, which is less effective because of the development of more energy-efficient products. There is also a requirement for a product information sheet. Labels already in use before 1 August 2017 will be rescaled by the European Commission, i.e. recalibrated to conform with the new regulation. The Commission adopts a separate delegated act for each specific product group to supplement the regulation. This establishes detailed requirements for labelling of specific product groups where: the product group has significant potential for energy saving; within the product group, equivalent models have significantly different levels of performance; there is no significant negative impact in terms of affordability or the overall costs of the product group. Delegated acts relating to specific product groups specify, among other things: the specific product group which is to be covered by the detailed labelling requirements; the design and content of the label, including a scale showing consumption of energy consisting of A to G, which should have a uniform design across product groups; other information emphasising the energy efficiency of the product; where appropriate, a reference in the label identifying products that are energy smart, i.e. capable of adapting and optimising consumption patterns; the measurement and calculation methods to be used to determine label and product information, including the definition of the energy efficiency index (EEI); the evaluation date and possible revision date of the delegated act; differences in energy performances in different climatic regions. The supplier and dealer responsibilities are to: display the energy efficiency class of the product and the range of classes available on the label; cooperate with market surveillance authorities and take immediate action to remedy any non-compliance; for products covered by delegated acts, not display other information likely to mislead customers about energy consumption; for products not covered by delegated acts, or non-energy related products, not display labels which mimic those under this regulation. Dealers, including online dealers, must display the label provided by the supplier and make available to customers the product information sheet at the point of sale. The Commission will establish a product registration database: to support market surveillance authorities in carrying out their tasks, including enforcement; to provide the public with information about products, their energy labels and product information sheets; to provide the Commission with up-to-date energy efficiency information to review energy labelling. The database will allow the public to consult product labels and information sheets, making it easier to compare the energy efficiency of household appliances. The regulation also requires manufacturers to inform consumers if software or firmware (software that is embedded in a piece of hardware and serves as the interface between that hardware and the operating system, e.g. on a smartphone or computer) updates could reduce a product\u2019s energy efficiency. It bans the use of \u2018defeat devices\u2019, which alter a product\u2019s performance under test conditions. By 2 August 2025, the Commission will assess the implementation of this regulation and submit a report to the European Parliament and to the Council. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 August 2017, except for the obligations of suppliers in relation to the product database which apply from 1 January 2019. BACKGROUND List of energy labelling measures \u2014 August 2017 (European Commission) Energy efficiency (European Commission) Energy efficient products (European Commission) Commission publishes new energy efficient labelling regulations to empower consumers (European Commission). MAIN DOCUMENT Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, pp. 1-23) RELATED DOCUMENTS Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, pp. 10-35) Successive amendments to Directive 2009/125/EC have been incorporated into the original document. This consolidated version is of documentary value only. Communication from the Commission to the European Parliament and the Council: European energy security strategy (COM(2014) 330 final, 28.5.2014). Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank \u2014 A framework strategy for a resilient energy union with a forward-looking climate change policy (COM(2015) 80 final, 25 February 2015) last update 27.06.2018"}
{"article": "4.5.2016 EN Official Journal of the European Union L 119/1 REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The protection of natural persons in relation to the processing of personal data is a fundamental right. Article 8(1) of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019) and Article 16(1) of the Treaty on the Functioning of the European Union (TFEU) provide that everyone has the right to the protection of personal data concerning him or her. (2) The principles of, and rules on the protection of natural persons with regard to the processing of their personal data should, whatever their nationality or residence, respect their fundamental rights and freedoms, in particular their right to the protection of personal data. This Regulation is intended to contribute to the accomplishment of an area of freedom, security and justice and of an economic union, to economic and social progress, to the strengthening and the convergence of the economies within the internal market, and to the well-being of natural persons. (3) Directive 95/46/EC of the European Parliament and of the Council (4) seeks to harmonise the protection of fundamental rights and freedoms of natural persons in respect of processing activities and to ensure the free flow of personal data between Member States. (4) The processing of personal data should be designed to serve mankind. The right to the protection of personal data is not an absolute right; it must be considered in relation to its function in society and be balanced against other fundamental rights, in accordance with the principle of proportionality. This Regulation respects all fundamental rights and observes the freedoms and principles recognised in the Charter as enshrined in the Treaties, in particular the respect for private and family life, home and communications, the protection of personal data, freedom of thought, conscience and religion, freedom of expression and information, freedom to conduct a business, the right to an effective remedy and to a fair trial, and cultural, religious and linguistic diversity. (5) The economic and social integration resulting from the functioning of the internal market has led to a substantial increase in cross-border flows of personal data. The exchange of personal data between public and private actors, including natural persons, associations and undertakings across the Union has increased. National authorities in the Member States are being called upon by Union law to cooperate and exchange personal data so as to be able to perform their duties or carry out tasks on behalf of an authority in another Member State. (6) Rapid technological developments and globalisation have brought new challenges for the protection of personal data. The scale of the collection and sharing of personal data has increased significantly. Technology allows both private companies and public authorities to make use of personal data on an unprecedented scale in order to pursue their activities. Natural persons increasingly make personal information available publicly and globally. Technology has transformed both the economy and social life, and should further facilitate the free flow of personal data within the Union and the transfer to third countries and international organisations, while ensuring a high level of the protection of personal data. (7) Those developments require a strong and more coherent data protection framework in the Union, backed by strong enforcement, given the importance of creating the trust that will allow the digital economy to develop across the internal market. Natural persons should have control of their own personal data. Legal and practical certainty for natural persons, economic operators and public authorities should be enhanced. (8) Where this Regulation provides for specifications or restrictions of its rules by Member State law, Member States may, as far as necessary for coherence and for making the national provisions comprehensible to the persons to whom they apply, incorporate elements of this Regulation into their national law. (9) The objectives and principles of Directive 95/46/EC remain sound, but it has not prevented fragmentation in the implementation of data protection across the Union, legal uncertainty or a widespread public perception that there are significant risks to the protection of natural persons, in particular with regard to online activity. Differences in the level of protection of the rights and freedoms of natural persons, in particular the right to the protection of personal data, with regard to the processing of personal data in the Member States may prevent the free flow of personal data throughout the Union. Those differences may therefore constitute an obstacle to the pursuit of economic activities at the level of the Union, distort competition and impede authorities in the discharge of their responsibilities under Union law. Such a difference in levels of protection is due to the existence of differences in the implementation and application of Directive 95/46/EC. (10) In order to ensure a consistent and high level of protection of natural persons and to remove the obstacles to flows of personal data within the Union, the level of protection of the rights and freedoms of natural persons with regard to the processing of such data should be equivalent in all Member States. Consistent and homogenous application of the rules for the protection of the fundamental rights and freedoms of natural persons with regard to the processing of personal data should be ensured throughout the Union. Regarding the processing of personal data for compliance with a legal obligation, for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, Member States should be allowed to maintain or introduce national provisions to further specify the application of the rules of this Regulation. In conjunction with the general and horizontal law on data protection implementing Directive 95/46/EC, Member States have several sector-specific laws in areas that need more specific provisions. This Regulation also provides a margin of manoeuvre for Member States to specify its rules, including for the processing of special categories of personal data (\u2018sensitive data\u2019). To that extent, this Regulation does not exclude Member State law that sets out the circumstances for specific processing situations, including determining more precisely the conditions under which the processing of personal data is lawful. (11) Effective protection of personal data throughout the Union requires the strengthening and setting out in detail of the rights of data subjects and the obligations of those who process and determine the processing of personal data, as well as equivalent powers for monitoring and ensuring compliance with the rules for the protection of personal data and equivalent sanctions for infringements in the Member States. (12) Article 16(2) TFEU mandates the European Parliament and the Council to lay down the rules relating to the protection of natural persons with regard to the processing of personal data and the rules relating to the free movement of personal data. (13) In order to ensure a consistent level of protection for natural persons throughout the Union and to prevent divergences hampering the free movement of personal data within the internal market, a Regulation is necessary to provide legal certainty and transparency for economic operators, including micro, small and medium-sized enterprises, and to provide natural persons in all Member States with the same level of legally enforceable rights and obligations and responsibilities for controllers and processors, to ensure consistent monitoring of the processing of personal data, and equivalent sanctions in all Member States as well as effective cooperation between the supervisory authorities of different Member States. The proper functioning of the internal market requires that the free movement of personal data within the Union is not restricted or prohibited for reasons connected with the protection of natural persons with regard to the processing of personal data. To take account of the specific situation of micro, small and medium-sized enterprises, this Regulation includes a derogation for organisations with fewer than 250 employees with regard to record-keeping. In addition, the Union institutions and bodies, and Member States and their supervisory authorities, are encouraged to take account of the specific needs of micro, small and medium-sized enterprises in the application of this Regulation. The notion of micro, small and medium-sized enterprises should draw from Article 2 of the Annex to Commission Recommendation 2003/361/EC (5). (14) The protection afforded by this Regulation should apply to natural persons, whatever their nationality or place of residence, in relation to the processing of their personal data. This Regulation does not cover the processing of personal data which concerns legal persons and in particular undertakings established as legal persons, including the name and the form of the legal person and the contact details of the legal person. (15) In order to prevent creating a serious risk of circumvention, the protection of natural persons should be technologically neutral and should not depend on the techniques used. The protection of natural persons should apply to the processing of personal data by automated means, as well as to manual processing, if the personal data are contained or are intended to be contained in a filing system. Files or sets of files, as well as their cover pages, which are not structured according to specific criteria should not fall within the scope of this Regulation. (16) This Regulation does not apply to issues of protection of fundamental rights and freedoms or the free flow of personal data related to activities which fall outside the scope of Union law, such as activities concerning national security. This Regulation does not apply to the processing of personal data by the Member States when carrying out activities in relation to the common foreign and security policy of the Union. (17) Regulation (EC) No 45/2001 of the European Parliament and of the Council (6) applies to the processing of personal data by the Union institutions, bodies, offices and agencies. Regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal data should be adapted to the principles and rules established in this Regulation and applied in the light of this Regulation. In order to provide a strong and coherent data protection framework in the Union, the necessary adaptations of Regulation (EC) No 45/2001 should follow after the adoption of this Regulation, in order to allow application at the same time as this Regulation. (18) This Regulation does not apply to the processing of personal data by a natural person in the course of a purely personal or household activity and thus with no connection to a professional or commercial activity. Personal or household activities could include correspondence and the holding of addresses, or social networking and online activity undertaken within the context of such activities. However, this Regulation applies to controllers or processors which provide the means for processing personal data for such personal or household activities. (19) The protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security and the free movement of such data, is the subject of a specific Union legal act. This Regulation should not, therefore, apply to processing activities for those purposes. However, personal data processed by public authorities under this Regulation should, when used for those purposes, be governed by a more specific Union legal act, namely Directive (EU) 2016/680 of the European Parliament and of the Council (7). Member States may entrust competent authorities within the meaning of Directive (EU) 2016/680 with tasks which are not necessarily carried out for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and prevention of threats to public security, so that the processing of personal data for those other purposes, in so far as it is within the scope of Union law, falls within the scope of this Regulation. With regard to the processing of personal data by those competent authorities for purposes falling within scope of this Regulation, Member States should be able to maintain or introduce more specific provisions to adapt the application of the rules of this Regulation. Such provisions may determine more precisely specific requirements for the processing of personal data by those competent authorities for those other purposes, taking into account the constitutional, organisational and administrative structure of the respective Member State. When the processing of personal data by private bodies falls within the scope of this Regulation, this Regulation should provide for the possibility for Member States under specific conditions to restrict by law certain obligations and rights when such a restriction constitutes a necessary and proportionate measure in a democratic society to safeguard specific important interests including public security and the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security. This is relevant for instance in the framework of anti-money laundering or the activities of forensic laboratories. (20) While this Regulation applies, inter alia, to the activities of courts and other judicial authorities, Union or Member State law could specify the processing operations and processing procedures in relation to the processing of personal data by courts and other judicial authorities. The competence of the supervisory authorities should not cover the processing of personal data when courts are acting in their judicial capacity, in order to safeguard the independence of the judiciary in the performance of its judicial tasks, including decision-making. It should be possible to entrust supervision of such data processing operations to specific bodies within the judicial system of the Member State, which should, in particular ensure compliance with the rules of this Regulation, enhance awareness among members of the judiciary of their obligations under this Regulation and handle complaints in relation to such data processing operations. (21) This Regulation is without prejudice to the application of Directive 2000/31/EC of the European Parliament and of the Council (8), in particular of the liability rules of intermediary service providers in Articles 12 to 15 of that Directive. That Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information society services between Member States. (22) Any processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union should be carried out in accordance with this Regulation, regardless of whether the processing itself takes place within the Union. Establishment implies the effective and real exercise of activity through stable arrangements. The legal form of such arrangements, whether through a branch or a subsidiary with a legal personality, is not the determining factor in that respect. (23) In order to ensure that natural persons are not deprived of the protection to which they are entitled under this Regulation, the processing of personal data of data subjects who are in the Union by a controller or a processor not established in the Union should be subject to this Regulation where the processing activities are related to offering goods or services to such data subjects irrespective of whether connected to a payment. In order to determine whether such a controller or processor is offering goods or services to data subjects who are in the Union, it should be ascertained whether it is apparent that the controller or processor envisages offering services to data subjects in one or more Member States in the Union. Whereas the mere accessibility of the controller's, processor's or an intermediary's website in the Union, of an email address or of other contact details, or the use of a language generally used in the third country where the controller is established, is insufficient to ascertain such intention, factors such as the use of a language or a currency generally used in one or more Member States with the possibility of ordering goods and services in that other language, or the mentioning of customers or users who are in the Union, may make it apparent that the controller envisages offering goods or services to data subjects in the Union. (24) The processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union should also be subject to this Regulation when it is related to the monitoring of the behaviour of such data subjects in so far as their behaviour takes place within the Union. In order to determine whether a processing activity can be considered to monitor the behaviour of data subjects, it should be ascertained whether natural persons are tracked on the internet including potential subsequent use of personal data processing techniques which consist of profiling a natural person, particularly in order to take decisions concerning her or him or for analysing or predicting her or his personal preferences, behaviours and attitudes. (25) Where Member State law applies by virtue of public international law, this Regulation should also apply to a controller not established in the Union, such as in a Member State's diplomatic mission or consular post. (26) The principles of data protection should apply to any information concerning an identified or identifiable natural person. Personal data which have undergone pseudonymisation, which could be attributed to a natural person by the use of additional information should be considered to be information on an identifiable natural person. To determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used, such as singling out, either by the controller or by another person to identify the natural person directly or indirectly. To ascertain whether means are reasonably likely to be used to identify the natural person, account should be taken of all objective factors, such as the costs of and the amount of time required for identification, taking into consideration the available technology at the time of the processing and technological developments. The principles of data protection should therefore not apply to anonymous information, namely information which does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable. This Regulation does not therefore concern the processing of such anonymous information, including for statistical or research purposes. (27) This Regulation does not apply to the personal data of deceased persons. Member States may provide for rules regarding the processing of personal data of deceased persons. (28) The application of pseudonymisation to personal data can reduce the risks to the data subjects concerned and help controllers and processors to meet their data-protection obligations. The explicit introduction of \u2018pseudonymisation\u2019 in this Regulation is not intended to preclude any other measures of data protection. (29) In order to create incentives to apply pseudonymisation when processing personal data, measures of pseudonymisation should, whilst allowing general analysis, be possible within the same controller when that controller has taken technical and organisational measures necessary to ensure, for the processing concerned, that this Regulation is implemented, and that additional information for attributing the personal data to a specific data subject is kept separately. The controller processing the personal data should indicate the authorised persons within the same controller. (30) Natural persons may be associated with online identifiers provided by their devices, applications, tools and protocols, such as internet protocol addresses, cookie identifiers or other identifiers such as radio frequency identification tags. This may leave traces which, in particular when combined with unique identifiers and other information received by the servers, may be used to create profiles of the natural persons and identify them. (31) Public authorities to which personal data are disclosed in accordance with a legal obligation for the exercise of their official mission, such as tax and customs authorities, financial investigation units, independent administrative authorities, or financial market authorities responsible for the regulation and supervision of securities markets should not be regarded as recipients if they receive personal data which are necessary to carry out a particular inquiry in the general interest, in accordance with Union or Member State law. The requests for disclosure sent by the public authorities should always be in writing, reasoned and occasional and should not concern the entirety of a filing system or lead to the interconnection of filing systems. The processing of personal data by those public authorities should comply with the applicable data-protection rules according to the purposes of the processing. (32) Consent should be given by a clear affirmative act establishing a freely given, specific, informed and unambiguous indication of the data subject's agreement to the processing of personal data relating to him or her, such as by a written statement, including by electronic means, or an oral statement. This could include ticking a box when visiting an internet website, choosing technical settings for information society services or another statement or conduct which clearly indicates in this context the data subject's acceptance of the proposed processing of his or her personal data. Silence, pre-ticked boxes or inactivity should not therefore constitute consent. Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them. If the data subject's consent is to be given following a request by electronic means, the request must be clear, concise and not unnecessarily disruptive to the use of the service for which it is provided. (33) It is often not possible to fully identify the purpose of personal data processing for scientific research purposes at the time of data collection. Therefore, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognised ethical standards for scientific research. Data subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose. (34) Genetic data should be defined as personal data relating to the inherited or acquired genetic characteristics of a natural person which result from the analysis of a biological sample from the natural person in question, in particular chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis, or from the analysis of another element enabling equivalent information to be obtained. (35) Personal data concerning health should include all data pertaining to the health status of a data subject which reveal information relating to the past, current or future physical or mental health status of the data subject. This includes information about the natural person collected in the course of the registration for, or the provision of, health care services as referred to in Directive 2011/24/EU of the European Parliament and of the Council (9) to that natural person; a number, symbol or particular assigned to a natural person to uniquely identify the natural person for health purposes; information derived from the testing or examination of a body part or bodily substance, including from genetic data and biological samples; and any information on, for example, a disease, disability, disease risk, medical history, clinical treatment or the physiological or biomedical state of the data subject independent of its source, for example from a physician or other health professional, a hospital, a medical device or an in vitro diagnostic test. (36) The main establishment of a controller in the Union should be the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal data are taken in another establishment of the controller in the Union, in which case that other establishment should be considered to be the main establishment. The main establishment of a controller in the Union should be determined according to objective criteria and should imply the effective and real exercise of management activities determining the main decisions as to the purposes and means of processing through stable arrangements. That criterion should not depend on whether the processing of personal data is carried out at that location. The presence and use of technical means and technologies for processing personal data or processing activities do not, in themselves, constitute a main establishment and are therefore not determining criteria for a main establishment. The main establishment of the processor should be the place of its central administration in the Union or, if it has no central administration in the Union, the place where the main processing activities take place in the Union. In cases involving both the controller and the processor, the competent lead supervisory authority should remain the supervisory authority of the Member State where the controller has its main establishment, but the supervisory authority of the processor should be considered to be a supervisory authority concerned and that supervisory authority should participate in the cooperation procedure provided for by this Regulation. In any case, the supervisory authorities of the Member State or Member States where the processor has one or more establishments should not be considered to be supervisory authorities concerned where the draft decision concerns only the controller. Where the processing is carried out by a group of undertakings, the main establishment of the controlling undertaking should be considered to be the main establishment of the group of undertakings, except where the purposes and means of processing are determined by another undertaking. (37) A group of undertakings should cover a controlling undertaking and its controlled undertakings, whereby the controlling undertaking should be the undertaking which can exert a dominant influence over the other undertakings by virtue, for example, of ownership, financial participation or the rules which govern it or the power to have personal data protection rules implemented. An undertaking which controls the processing of personal data in undertakings affiliated to it should be regarded, together with those undertakings, as a group of undertakings. (38) Children merit specific protection with regard to their personal data, as they may be less aware of the risks, consequences and safeguards concerned and their rights in relation to the processing of personal data. Such specific protection should, in particular, apply to the use of personal data of children for the purposes of marketing or creating personality or user profiles and the collection of personal data with regard to children when using services offered directly to a child. The consent of the holder of parental responsibility should not be necessary in the context of preventive or counselling services offered directly to a child. (39) Any processing of personal data should be lawful and fair. It should be transparent to natural persons that personal data concerning them are collected, used, consulted or otherwise processed and to what extent the personal data are or will be processed. The principle of transparency requires that any information and communication relating to the processing of those personal data be easily accessible and easy to understand, and that clear and plain language be used. That principle concerns, in particular, information to the data subjects on the identity of the controller and the purposes of the processing and further information to ensure fair and transparent processing in respect of the natural persons concerned and their right to obtain confirmation and communication of personal data concerning them which are being processed. Natural persons should be made aware of risks, rules, safeguards and rights in relation to the processing of personal data and how to exercise their rights in relation to such processing. In particular, the specific purposes for which personal data are processed should be explicit and legitimate and determined at the time of the collection of the personal data. The personal data should be adequate, relevant and limited to what is necessary for the purposes for which they are processed. This requires, in particular, ensuring that the period for which the personal data are stored is limited to a strict minimum. Personal data should be processed only if the purpose of the processing could not reasonably be fulfilled by other means. In order to ensure that the personal data are not kept longer than necessary, time limits should be established by the controller for erasure or for a periodic review. Every reasonable step should be taken to ensure that personal data which are inaccurate are rectified or deleted. Personal data should be processed in a manner that ensures appropriate security and confidentiality of the personal data, including for preventing unauthorised access to or use of personal data and the equipment used for the processing. (40) In order for processing to be lawful, personal data should be processed on the basis of the consent of the data subject concerned or some other legitimate basis, laid down by law, either in this Regulation or in other Union or Member State law as referred to in this Regulation, including the necessity for compliance with the legal obligation to which the controller is subject or the necessity for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract. (41) Where this Regulation refers to a legal basis or a legislative measure, this does not necessarily require a legislative act adopted by a parliament, without prejudice to requirements pursuant to the constitutional order of the Member State concerned. However, such a legal basis or legislative measure should be clear and precise and its application should be foreseeable to persons subject to it, in accordance with the case-law of the Court of Justice of the European Union (the \u2018Court of Justice\u2019) and the European Court of Human Rights. (42) Where processing is based on the data subject's consent, the controller should be able to demonstrate that the data subject has given consent to the processing operation. In particular in the context of a written declaration on another matter, safeguards should ensure that the data subject is aware of the fact that and the extent to which consent is given. In accordance with Council Directive 93/13/EEC (10) a declaration of consent pre-formulated by the controller should be provided in an intelligible and easily accessible form, using clear and plain language and it should not contain unfair terms. For consent to be informed, the data subject should be aware at least of the identity of the controller and the purposes of the processing for which the personal data are intended. Consent should not be regarded as freely given if the data subject has no genuine or free choice or is unable to refuse or withdraw consent without detriment. (43) In order to ensure that consent is freely given, consent should not provide a valid legal ground for the processing of personal data in a specific case where there is a clear imbalance between the data subject and the controller, in particular where the controller is a public authority and it is therefore unlikely that consent was freely given in all the circumstances of that specific situation. Consent is presumed not to be freely given if it does not allow separate consent to be given to different personal data processing operations despite it being appropriate in the individual case, or if the performance of a contract, including the provision of a service, is dependent on the consent despite such consent not being necessary for such performance. (44) Processing should be lawful where it is necessary in the context of a contract or the intention to enter into a contract. (45) Where processing is carried out in accordance with a legal obligation to which the controller is subject or where processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority, the processing should have a basis in Union or Member State law. This Regulation does not require a specific law for each individual processing. A law as a basis for several processing operations based on a legal obligation to which the controller is subject or where processing is necessary for the performance of a task carried out in the public interest or in the exercise of an official authority may be sufficient. It should also be for Union or Member State law to determine the purpose of processing. Furthermore, that law could specify the general conditions of this Regulation governing the lawfulness of personal data processing, establish specifications for determining the controller, the type of personal data which are subject to the processing, the data subjects concerned, the entities to which the personal data may be disclosed, the purpose limitations, the storage period and other measures to ensure lawful and fair processing. It should also be for Union or Member State law to determine whether the controller performing a task carried out in the public interest or in the exercise of official authority should be a public authority or another natural or legal person governed by public law, or, where it is in the public interest to do so, including for health purposes such as public health and social protection and the management of health care services, by private law, such as a professional association. (46) The processing of personal data should also be regarded to be lawful where it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. Some types of processing may serve both important grounds of public interest and the vital interests of the data subject as for instance when processing is necessary for humanitarian purposes, including for monitoring epidemics and their spread or in situations of humanitarian emergencies, in particular in situations of natural and man-made disasters. (47) The legitimate interests of a controller, including those of a controller to which the personal data may be disclosed, or of a third party, may provide a legal basis for processing, provided that the interests or the fundamental rights and freedoms of the data subject are not overriding, taking into consideration the reasonable expectations of data subjects based on their relationship with the controller. Such legitimate interest could exist for example where there is a relevant and appropriate relationship between the data subject and the controller in situations such as where the data subject is a client or in the service of the controller. At any rate the existence of a legitimate interest would need careful assessment including whether a data subject can reasonably expect at the time and in the context of the collection of the personal data that processing for that purpose may take place. The interests and fundamental rights of the data subject could in particular override the interest of the data controller where personal data are processed in circumstances where data subjects do not reasonably expect further processing. Given that it is for the legislator to provide by law for the legal basis for public authorities to process personal data, that legal basis should not apply to the processing by public authorities in the performance of their tasks. The processing of personal data strictly necessary for the purposes of preventing fraud also constitutes a legitimate interest of the data controller concerned. The processing of personal data for direct marketing purposes may be regarded as carried out for a legitimate interest. (48) Controllers that are part of a group of undertakings or institutions affiliated to a central body may have a legitimate interest in transmitting personal data within the group of undertakings for internal administrative purposes, including the processing of clients' or employees' personal data. The general principles for the transfer of personal data, within a group of undertakings, to an undertaking located in a third country remain unaffected. (49) The processing of personal data to the extent strictly necessary and proportionate for the purposes of ensuring network and information security, i.e. the ability of a network or an information system to resist, at a given level of confidence, accidental events or unlawful or malicious actions that compromise the availability, authenticity, integrity and confidentiality of stored or transmitted personal data, and the security of the related services offered by, or accessible via, those networks and systems, by public authorities, by computer emergency response teams (CERTs), computer security incident response teams (CSIRTs), by providers of electronic communications networks and services and by providers of security technologies and services, constitutes a legitimate interest of the data controller concerned. This could, for example, include preventing unauthorised access to electronic communications networks and malicious code distribution and stopping \u2018denial of service\u2019 attacks and damage to computer and electronic communication systems. (50) The processing of personal data for purposes other than those for which the personal data were initially collected should be allowed only where the processing is compatible with the purposes for which the personal data were initially collected. In such a case, no legal basis separate from that which allowed the collection of the personal data is required. If the processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, Union or Member State law may determine and specify the tasks and purposes for which the further processing should be regarded as compatible and lawful. Further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes should be considered to be compatible lawful processing operations. The legal basis provided by Union or Member State law for the processing of personal data may also provide a legal basis for further processing. In order to ascertain whether a purpose of further processing is compatible with the purpose for which the personal data are initially collected, the controller, after having met all the requirements for the lawfulness of the original processing, should take into account, inter alia: any link between those purposes and the purposes of the intended further processing; the context in which the personal data have been collected, in particular the reasonable expectations of data subjects based on their relationship with the controller as to their further use; the nature of the personal data; the consequences of the intended further processing for data subjects; and the existence of appropriate safeguards in both the original and intended further processing operations. Where the data subject has given consent or the processing is based on Union or Member State law which constitutes a necessary and proportionate measure in a democratic society to safeguard, in particular, important objectives of general public interest, the controller should be allowed to further process the personal data irrespective of the compatibility of the purposes. In any case, the application of the principles set out in this Regulation and in particular the information of the data subject on those other purposes and on his or her rights including the right to object, should be ensured. Indicating possible criminal acts or threats to public security by the controller and transmitting the relevant personal data in individual cases or in several cases relating to the same criminal act or threats to public security to a competent authority should be regarded as being in the legitimate interest pursued by the controller. However, such transmission in the legitimate interest of the controller or further processing of personal data should be prohibited if the processing is not compatible with a legal, professional or other binding obligation of secrecy. (51) Personal data which are, by their nature, particularly sensitive in relation to fundamental rights and freedoms merit specific protection as the context of their processing could create significant risks to the fundamental rights and freedoms. Those personal data should include personal data revealing racial or ethnic origin, whereby the use of the term \u2018racial origin\u2019 in this Regulation does not imply an acceptance by the Union of theories which attempt to determine the existence of separate human races. The processing of photographs should not systematically be considered to be processing of special categories of personal data as they are covered by the definition of biometric data only when processed through a specific technical means allowing the unique identification or authentication of a natural person. Such personal data should not be processed, unless processing is allowed in specific cases set out in this Regulation, taking into account that Member States law may lay down specific provisions on data protection in order to adapt the application of the rules of this Regulation for compliance with a legal obligation or for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. In addition to the specific requirements for such processing, the general principles and other rules of this Regulation should apply, in particular as regards the conditions for lawful processing. Derogations from the general prohibition for processing such special categories of personal data should be explicitly provided, inter alia, where the data subject gives his or her explicit consent or in respect of specific needs in particular where the processing is carried out in the course of legitimate activities by certain associations or foundations the purpose of which is to permit the exercise of fundamental freedoms. (52) Derogating from the prohibition on processing special categories of personal data should also be allowed when provided for in Union or Member State law and subject to suitable safeguards, so as to protect personal data and other fundamental rights, where it is in the public interest to do so, in particular processing personal data in the field of employment law, social protection law including pensions and for health security, monitoring and alert purposes, the prevention or control of communicable diseases and other serious threats to health. Such a derogation may be made for health purposes, including public health and the management of health-care services, especially in order to ensure the quality and cost-effectiveness of the procedures used for settling claims for benefits and services in the health insurance system, or for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. A derogation should also allow the processing of such personal data where necessary for the establishment, exercise or defence of legal claims, whether in court proceedings or in an administrative or out-of-court procedure. (53) Special categories of personal data which merit higher protection should be processed for health-related purposes only where necessary to achieve those purposes for the benefit of natural persons and society as a whole, in particular in the context of the management of health or social care services and systems, including processing by the management and central national health authorities of such data for the purpose of quality control, management information and the general national and local supervision of the health or social care system, and ensuring continuity of health or social care and cross-border healthcare or health security, monitoring and alert purposes, or for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, based on Union or Member State law which has to meet an objective of public interest, as well as for studies conducted in the public interest in the area of public health. Therefore, this Regulation should provide for harmonised conditions for the processing of special categories of personal data concerning health, in respect of specific needs, in particular where the processing of such data is carried out for certain health-related purposes by persons subject to a legal obligation of professional secrecy. Union or Member State law should provide for specific and suitable measures so as to protect the fundamental rights and the personal data of natural persons. Member States should be allowed to maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health. However, this should not hamper the free flow of personal data within the Union when those conditions apply to cross-border processing of such data. (54) The processing of special categories of personal data may be necessary for reasons of public interest in the areas of public health without consent of the data subject. Such processing should be subject to suitable and specific measures so as to protect the rights and freedoms of natural persons. In that context, \u2018public health\u2019 should be interpreted as defined in Regulation (EC) No 1338/2008 of the European Parliament and of the Council (11), namely all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and universal access to, health care as well as health care expenditure and financing, and the causes of mortality. Such processing of data concerning health for reasons of public interest should not result in personal data being processed for other purposes by third parties such as employers or insurance and banking companies. (55) Moreover, the processing of personal data by official authorities for the purpose of achieving the aims, laid down by constitutional law or by international public law, of officially recognised religious associations, is carried out on grounds of public interest. (56) Where in the course of electoral activities, the operation of the democratic system in a Member State requires that political parties compile personal data on people's political opinions, the processing of such data may be permitted for reasons of public interest, provided that appropriate safeguards are established. (57) If the personal data processed by a controller do not permit the controller to identify a natural person, the data controller should not be obliged to acquire additional information in order to identify the data subject for the sole purpose of complying with any provision of this Regulation. However, the controller should not refuse to take additional information provided by the data subject in order to support the exercise of his or her rights. Identification should include the digital identification of a data subject, for example through authentication mechanism such as the same credentials, used by the data subject to log-in to the on-line service offered by the data controller. (58) The principle of transparency requires that any information addressed to the public or to the data subject be concise, easily accessible and easy to understand, and that clear and plain language and, additionally, where appropriate, visualisation be used. Such information could be provided in electronic form, for example, when addressed to the public, through a website. This is of particular relevance in situations where the proliferation of actors and the technological complexity of practice make it difficult for the data subject to know and understand whether, by whom and for what purpose personal data relating to him or her are being collected, such as in the case of online advertising. Given that children merit specific protection, any information and communication, where processing is addressed to a child, should be in such a clear and plain language that the child can easily understand. (59) Modalities should be provided for facilitating the exercise of the data subject's rights under this Regulation, including mechanisms to request and, if applicable, obtain, free of charge, in particular, access to and rectification or erasure of personal data and the exercise of the right to object. The controller should also provide means for requests to be made electronically, especially where personal data are processed by electronic means. The controller should be obliged to respond to requests from the data subject without undue delay and at the latest within one month and to give reasons where the controller does not intend to comply with any such requests. (60) The principles of fair and transparent processing require that the data subject be informed of the existence of the processing operation and its purposes. The controller should provide the data subject with any further information necessary to ensure fair and transparent processing taking into account the specific circumstances and context in which the personal data are processed. Furthermore, the data subject should be informed of the existence of profiling and the consequences of such profiling. Where the personal data are collected from the data subject, the data subject should also be informed whether he or she is obliged to provide the personal data and of the consequences, where he or she does not provide such data. That information may be provided in combination with standardised icons in order to give in an easily visible, intelligible and clearly legible manner, a meaningful overview of the intended processing. Where the icons are presented electronically, they should be machine-readable. (61) The information in relation to the processing of personal data relating to the data subject should be given to him or her at the time of collection from the data subject, or, where the personal data are obtained from another source, within a reasonable period, depending on the circumstances of the case. Where personal data can be legitimately disclosed to another recipient, the data subject should be informed when the personal data are first disclosed to the recipient. Where the controller intends to process the personal data for a purpose other than that for which they were collected, the controller should provide the data subject prior to that further processing with information on that other purpose and other necessary information. Where the origin of the personal data cannot be provided to the data subject because various sources have been used, general information should be provided. (62) However, it is not necessary to impose the obligation to provide information where the data subject already possesses the information, where the recording or disclosure of the personal data is expressly laid down by law or where the provision of information to the data subject proves to be impossible or would involve a disproportionate effort. The latter could in particular be the case where processing is carried out for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. In that regard, the number of data subjects, the age of the data and any appropriate safeguards adopted should be taken into consideration. (63) A data subject should have the right of access to personal data which have been collected concerning him or her, and to exercise that right easily and at reasonable intervals, in order to be aware of, and verify, the lawfulness of the processing. This includes the right for data subjects to have access to data concerning their health, for example the data in their medical records containing information such as diagnoses, examination results, assessments by treating physicians and any treatment or interventions provided. Every data subject should therefore have the right to know and obtain communication in particular with regard to the purposes for which the personal data are processed, where possible the period for which the personal data are processed, the recipients of the personal data, the logic involved in any automatic personal data processing and, at least when based on profiling, the consequences of such processing. Where possible, the controller should be able to provide remote access to a secure system which would provide the data subject with direct access to his or her personal data. That right should not adversely affect the rights or freedoms of others, including trade secrets or intellectual property and in particular the copyright protecting the software. However, the result of those considerations should not be a refusal to provide all information to the data subject. Where the controller processes a large quantity of information concerning the data subject, the controller should be able to request that, before the information is delivered, the data subject specify the information or processing activities to which the request relates. (64) The controller should use all reasonable measures to verify the identity of a data subject who requests access, in particular in the context of online services and online identifiers. A controller should not retain personal data for the sole purpose of being able to react to potential requests. (65) A data subject should have the right to have personal data concerning him or her rectified and a \u2018right to be forgotten\u2019 where the retention of such data infringes this Regulation or Union or Member State law to which the controller is subject. In particular, a data subject should have the right to have his or her personal data erased and no longer processed where the personal data are no longer necessary in relation to the purposes for which they are collected or otherwise processed, where a data subject has withdrawn his or her consent or objects to the processing of personal data concerning him or her, or where the processing of his or her personal data does not otherwise comply with this Regulation. That right is relevant in particular where the data subject has given his or her consent as a child and is not fully aware of the risks involved by the processing, and later wants to remove such personal data, especially on the internet. The data subject should be able to exercise that right notwithstanding the fact that he or she is no longer a child. However, the further retention of the personal data should be lawful where it is necessary, for exercising the right of freedom of expression and information, for compliance with a legal obligation, for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, on the grounds of public interest in the area of public health, for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, or for the establishment, exercise or defence of legal claims. (66) To strengthen the right to be forgotten in the online environment, the right to erasure should also be extended in such a way that a controller who has made the personal data public should be obliged to inform the controllers which are processing such personal data to erase any links to, or copies or replications of those personal data. In doing so, that controller should take reasonable steps, taking into account available technology and the means available to the controller, including technical measures, to inform the controllers which are processing the personal data of the data subject's request. (67) Methods by which to restrict the processing of personal data could include, inter alia, temporarily moving the selected data to another processing system, making the selected personal data unavailable to users, or temporarily removing published data from a website. In automated filing systems, the restriction of processing should in principle be ensured by technical means in such a manner that the personal data are not subject to further processing operations and cannot be changed. The fact that the processing of personal data is restricted should be clearly indicated in the system. (68) To further strengthen the control over his or her own data, where the processing of personal data is carried out by automated means, the data subject should also be allowed to receive personal data concerning him or her which he or she has provided to a controller in a structured, commonly used, machine-readable and interoperable format, and to transmit it to another controller. Data controllers should be encouraged to develop interoperable formats that enable data portability. That right should apply where the data subject provided the personal data on the basis of his or her consent or the processing is necessary for the performance of a contract. It should not apply where processing is based on a legal ground other than consent or contract. By its very nature, that right should not be exercised against controllers processing personal data in the exercise of their public duties. It should therefore not apply where the processing of the personal data is necessary for compliance with a legal obligation to which the controller is subject or for the performance of a task carried out in the public interest or in the exercise of an official authority vested in the controller. The data subject's right to transmit or receive personal data concerning him or her should not create an obligation for the controllers to adopt or maintain processing systems which are technically compatible. Where, in a certain set of personal data, more than one data subject is concerned, the right to receive the personal data should be without prejudice to the rights and freedoms of other data subjects in accordance with this Regulation. Furthermore, that right should not prejudice the right of the data subject to obtain the erasure of personal data and the limitations of that right as set out in this Regulation and should, in particular, not imply the erasure of personal data concerning the data subject which have been provided by him or her for the performance of a contract to the extent that and for as long as the personal data are necessary for the performance of that contract. Where technically feasible, the data subject should have the right to have the personal data transmitted directly from one controller to another. (69) Where personal data might lawfully be processed because processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, or on grounds of the legitimate interests of a controller or a third party, a data subject should, nevertheless, be entitled to object to the processing of any personal data relating to his or her particular situation. It should be for the controller to demonstrate that its compelling legitimate interest overrides the interests or the fundamental rights and freedoms of the data subject. (70) Where personal data are processed for the purposes of direct marketing, the data subject should have the right to object to such processing, including profiling to the extent that it is related to such direct marketing, whether with regard to initial or further processing, at any time and free of charge. That right should be explicitly brought to the attention of the data subject and presented clearly and separately from any other information. (71) The data subject should have the right not to be subject to a decision, which may include a measure, evaluating personal aspects relating to him or her which is based solely on automated processing and which produces legal effects concerning him or her or similarly significantly affects him or her, such as automatic refusal of an online credit application or e-recruiting practices without any human intervention. Such processing includes \u2018profiling\u2019 that consists of any form of automated processing of personal data evaluating the personal aspects relating to a natural person, in particular to analyse or predict aspects concerning the data subject's performance at work, economic situation, health, personal preferences or interests, reliability or behaviour, location or movements, where it produces legal effects concerning him or her or similarly significantly affects him or her. However, decision-making based on such processing, including profiling, should be allowed where expressly authorised by Union or Member State law to which the controller is subject, including for fraud and tax-evasion monitoring and prevention purposes conducted in accordance with the regulations, standards and recommendations of Union institutions or national oversight bodies and to ensure the security and reliability of a service provided by the controller, or necessary for the entering or performance of a contract between the data subject and a controller, or when the data subject has given his or her explicit consent. In any case, such processing should be subject to suitable safeguards, which should include specific information to the data subject and the right to obtain human intervention, to express his or her point of view, to obtain an explanation of the decision reached after such assessment and to challenge the decision. Such measure should not concern a child. In order to ensure fair and transparent processing in respect of the data subject, taking into account the specific circumstances and context in which the personal data are processed, the controller should use appropriate mathematical or statistical procedures for the profiling, implement technical and organisational measures appropriate to ensure, in particular, that factors which result in inaccuracies in personal data are corrected and the risk of errors is minimised, secure personal data in a manner that takes account of the potential risks involved for the interests and rights of the data subject and that prevents, inter alia, discriminatory effects on natural persons on the basis of racial or ethnic origin, political opinion, religion or beliefs, trade union membership, genetic or health status or sexual orientation, or that result in measures having such an effect. Automated decision-making and profiling based on special categories of personal data should be allowed only under specific conditions. (72) Profiling is subject to the rules of this Regulation governing the processing of personal data, such as the legal grounds for processing or data protection principles. The European Data Protection Board established by this Regulation (the \u2018Board\u2019) should be able to issue guidance in that context. (73) Restrictions concerning specific principles and the rights of information, access to and rectification or erasure of personal data, the right to data portability, the right to object, decisions based on profiling, as well as the communication of a personal data breach to a data subject and certain related obligations of the controllers may be imposed by Union or Member State law, as far as necessary and proportionate in a democratic society to safeguard public security, including the protection of human life especially in response to natural or manmade disasters, the prevention, investigation and prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security, or of breaches of ethics for regulated professions, other important objectives of general public interest of the Union or of a Member State, in particular an important economic or financial interest of the Union or of a Member State, the keeping of public registers kept for reasons of general public interest, further processing of archived personal data to provide specific information related to the political behaviour under former totalitarian state regimes or the protection of the data subject or the rights and freedoms of others, including social protection, public health and humanitarian purposes. Those restrictions should be in accordance with the requirements set out in the Charter and in the European Convention for the Protection of Human Rights and Fundamental Freedoms. (74) The responsibility and liability of the controller for any processing of personal data carried out by the controller or on the controller's behalf should be established. In particular, the controller should be obliged to implement appropriate and effective measures and be able to demonstrate the compliance of processing activities with this Regulation, including the effectiveness of the measures. Those measures should take into account the nature, scope, context and purposes of the processing and the risk to the rights and freedoms of natural persons. (75) The risk to the rights and freedoms of natural persons, of varying likelihood and severity, may result from personal data processing which could lead to physical, material or non-material damage, in particular: where the processing may give rise to discrimination, identity theft or fraud, financial loss, damage to the reputation, loss of confidentiality of personal data protected by professional secrecy, unauthorised reversal of pseudonymisation, or any other significant economic or social disadvantage; where data subjects might be deprived of their rights and freedoms or prevented from exercising control over their personal data; where personal data are processed which reveal racial or ethnic origin, political opinions, religion or philosophical beliefs, trade union membership, and the processing of genetic data, data concerning health or data concerning sex life or criminal convictions and offences or related security measures; where personal aspects are evaluated, in particular analysing or predicting aspects concerning performance at work, economic situation, health, personal preferences or interests, reliability or behaviour, location or movements, in order to create or use personal profiles; where personal data of vulnerable natural persons, in particular of children, are processed; or where processing involves a large amount of personal data and affects a large number of data subjects. (76) The likelihood and severity of the risk to the rights and freedoms of the data subject should be determined by reference to the nature, scope, context and purposes of the processing. Risk should be evaluated on the basis of an objective assessment, by which it is established whether data processing operations involve a risk or a high risk. (77) Guidance on the implementation of appropriate measures and on the demonstration of compliance by the controller or the processor, especially as regards the identification of the risk related to the processing, their assessment in terms of origin, nature, likelihood and severity, and the identification of best practices to mitigate the risk, could be provided in particular by means of approved codes of conduct, approved certifications, guidelines provided by the Board or indications provided by a data protection officer. The Board may also issue guidelines on processing operations that are considered to be unlikely to result in a high risk to the rights and freedoms of natural persons and indicate what measures may be sufficient in such cases to address such risk. (78) The protection of the rights and freedoms of natural persons with regard to the processing of personal data require that appropriate technical and organisational measures be taken to ensure that the requirements of this Regulation are met. In order to be able to demonstrate compliance with this Regulation, the controller should adopt internal policies and implement measures which meet in particular the principles of data protection by design and data protection by default. Such measures could consist, inter alia, of minimising the processing of personal data, pseudonymising personal data as soon as possible, transparency with regard to the functions and processing of personal data, enabling the data subject to monitor the data processing, enabling the controller to create and improve security features. When developing, designing, selecting and using applications, services and products that are based on the processing of personal data or process personal data to fulfil their task, producers of the products, services and applications should be encouraged to take into account the right to data protection when developing and designing such products, services and applications and, with due regard to the state of the art, to make sure that controllers and processors are able to fulfil their data protection obligations. The principles of data protection by design and by default should also be taken into consideration in the context of public tenders. (79) The protection of the rights and freedoms of data subjects as well as the responsibility and liability of controllers and processors, also in relation to the monitoring by and measures of supervisory authorities, requires a clear allocation of the responsibilities under this Regulation, including where a controller determines the purposes and means of the processing jointly with other controllers or where a processing operation is carried out on behalf of a controller. (80) Where a controller or a processor not established in the Union is processing personal data of data subjects who are in the Union whose processing activities are related to the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union, or to the monitoring of their behaviour as far as their behaviour takes place within the Union, the controller or the processor should designate a representative, unless the processing is occasional, does not include processing, on a large scale, of special categories of personal data or the processing of personal data relating to criminal convictions and offences, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature, context, scope and purposes of the processing or if the controller is a public authority or body. The representative should act on behalf of the controller or the processor and may be addressed by any supervisory authority. The representative should be explicitly designated by a written mandate of the controller or of the processor to act on its behalf with regard to its obligations under this Regulation. The designation of such a representative does not affect the responsibility or liability of the controller or of the processor under this Regulation. Such a representative should perform its tasks according to the mandate received from the controller or processor, including cooperating with the competent supervisory authorities with regard to any action taken to ensure compliance with this Regulation. The designated representative should be subject to enforcement proceedings in the event of non-compliance by the controller or processor. (81) To ensure compliance with the requirements of this Regulation in respect of the processing to be carried out by the processor on behalf of the controller, when entrusting a processor with processing activities, the controller should use only processors providing sufficient guarantees, in particular in terms of expert knowledge, reliability and resources, to implement technical and organisational measures which will meet the requirements of this Regulation, including for the security of processing. The adherence of the processor to an approved code of conduct or an approved certification mechanism may be used as an element to demonstrate compliance with the obligations of the controller. The carrying-out of processing by a processor should be governed by a contract or other legal act under Union or Member State law, binding the processor to the controller, setting out the subject-matter and duration of the processing, the nature and purposes of the processing, the type of personal data and categories of data subjects, taking into account the specific tasks and responsibilities of the processor in the context of the processing to be carried out and the risk to the rights and freedoms of the data subject. The controller and processor may choose to use an individual contract or standard contractual clauses which are adopted either directly by the Commission or by a supervisory authority in accordance with the consistency mechanism and then adopted by the Commission. After the completion of the processing on behalf of the controller, the processor should, at the choice of the controller, return or delete the personal data, unless there is a requirement to store the personal data under Union or Member State law to which the processor is subject. (82) In order to demonstrate compliance with this Regulation, the controller or processor should maintain records of processing activities under its responsibility. Each controller and processor should be obliged to cooperate with the supervisory authority and make those records, on request, available to it, so that it might serve for monitoring those processing operations. (83) In order to maintain security and to prevent processing in infringement of this Regulation, the controller or processor should evaluate the risks inherent in the processing and implement measures to mitigate those risks, such as encryption. Those measures should ensure an appropriate level of security, including confidentiality, taking into account the state of the art and the costs of implementation in relation to the risks and the nature of the personal data to be protected. In assessing data security risk, consideration should be given to the risks that are presented by personal data processing, such as accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed which may in particular lead to physical, material or non-material damage. (84) In order to enhance compliance with this Regulation where processing operations are likely to result in a high risk to the rights and freedoms of natural persons, the controller should be responsible for the carrying-out of a data protection impact assessment to evaluate, in particular, the origin, nature, particularity and severity of that risk. The outcome of the assessment should be taken into account when determining the appropriate measures to be taken in order to demonstrate that the processing of personal data complies with this Regulation. Where a data-protection impact assessment indicates that processing operations involve a high risk which the controller cannot mitigate by appropriate measures in terms of available technology and costs of implementation, a consultation of the supervisory authority should take place prior to the processing. (85) A personal data breach may, if not addressed in an appropriate and timely manner, result in physical, material or non-material damage to natural persons such as loss of control over their personal data or limitation of their rights, discrimination, identity theft or fraud, financial loss, unauthorised reversal of pseudonymisation, damage to reputation, loss of confidentiality of personal data protected by professional secrecy or any other significant economic or social disadvantage to the natural person concerned. Therefore, as soon as the controller becomes aware that a personal data breach has occurred, the controller should notify the personal data breach to the supervisory authority without undue delay and, where feasible, not later than 72 hours after having become aware of it, unless the controller is able to demonstrate, in accordance with the accountability principle, that the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons. Where such notification cannot be achieved within 72 hours, the reasons for the delay should accompany the notification and information may be provided in phases without undue further delay. (86) The controller should communicate to the data subject a personal data breach, without undue delay, where that personal data breach is likely to result in a high risk to the rights and freedoms of the natural person in order to allow him or her to take the necessary precautions. The communication should describe the nature of the personal data breach as well as recommendations for the natural person concerned to mitigate potential adverse effects. Such communications to data subjects should be made as soon as reasonably feasible and in close cooperation with the supervisory authority, respecting guidance provided by it or by other relevant authorities such as law-enforcement authorities. For example, the need to mitigate an immediate risk of damage would call for prompt communication with data subjects whereas the need to implement appropriate measures against continuing or similar personal data breaches may justify more time for communication. (87) It should be ascertained whether all appropriate technological protection and organisational measures have been implemented to establish immediately whether a personal data breach has taken place and to inform promptly the supervisory authority and the data subject. The fact that the notification was made without undue delay should be established taking into account in particular the nature and gravity of the personal data breach and its consequences and adverse effects for the data subject. Such notification may result in an intervention of the supervisory authority in accordance with its tasks and powers laid down in this Regulation. (88) In setting detailed rules concerning the format and procedures applicable to the notification of personal data breaches, due consideration should be given to the circumstances of that breach, including whether or not personal data had been protected by appropriate technical protection measures, effectively limiting the likelihood of identity fraud or other forms of misuse. Moreover, such rules and procedures should take into account the legitimate interests of law-enforcement authorities where early disclosure could unnecessarily hamper the investigation of the circumstances of a personal data breach. (89) Directive 95/46/EC provided for a general obligation to notify the processing of personal data to the supervisory authorities. While that obligation produces administrative and financial burdens, it did not in all cases contribute to improving the protection of personal data. Such indiscriminate general notification obligations should therefore be abolished, and replaced by effective procedures and mechanisms which focus instead on those types of processing operations which are likely to result in a high risk to the rights and freedoms of natural persons by virtue of their nature, scope, context and purposes. Such types of processing operations may be those which in, particular, involve using new technologies, or are of a new kind and where no data protection impact assessment has been carried out before by the controller, or where they become necessary in the light of the time that has elapsed since the initial processing. (90) In such cases, a data protection impact assessment should be carried out by the controller prior to the processing in order to assess the particular likelihood and severity of the high risk, taking into account the nature, scope, context and purposes of the processing and the sources of the risk. That impact assessment should include, in particular, the measures, safeguards and mechanisms envisaged for mitigating that risk, ensuring the protection of personal data and demonstrating compliance with this Regulation. (91) This should in particular apply to large-scale processing operations which aim to process a considerable amount of personal data at regional, national or supranational level and which could affect a large number of data subjects and which are likely to result in a high risk, for example, on account of their sensitivity, where in accordance with the achieved state of technological knowledge a new technology is used on a large scale as well as to other processing operations which result in a high risk to the rights and freedoms of data subjects, in particular where those operations render it more difficult for data subjects to exercise their rights. A data protection impact assessment should also be made where personal data are processed for taking decisions regarding specific natural persons following any systematic and extensive evaluation of personal aspects relating to natural persons based on profiling those data or following the processing of special categories of personal data, biometric data, or data on criminal convictions and offences or related security measures. A data protection impact assessment is equally required for monitoring publicly accessible areas on a large scale, especially when using optic-electronic devices or for any other operations where the competent supervisory authority considers that the processing is likely to result in a high risk to the rights and freedoms of data subjects, in particular because they prevent data subjects from exercising a right or using a service or a contract, or because they are carried out systematically on a large scale. The processing of personal data should not be considered to be on a large scale if the processing concerns personal data from patients or clients by an individual physician, other health care professional or lawyer. In such cases, a data protection impact assessment should not be mandatory. (92) There are circumstances under which it may be reasonable and economical for the subject of a data protection impact assessment to be broader than a single project, for example where public authorities or bodies intend to establish a common application or processing platform or where several controllers plan to introduce a common application or processing environment across an industry sector or segment or for a widely used horizontal activity. (93) In the context of the adoption of the Member State law on which the performance of the tasks of the public authority or public body is based and which regulates the specific processing operation or set of operations in question, Member States may deem it necessary to carry out such assessment prior to the processing activities. (94) Where a data protection impact assessment indicates that the processing would, in the absence of safeguards, security measures and mechanisms to mitigate the risk, result in a high risk to the rights and freedoms of natural persons and the controller is of the opinion that the risk cannot be mitigated by reasonable means in terms of available technologies and costs of implementation, the supervisory authority should be consulted prior to the start of processing activities. Such high risk is likely to result from certain types of processing and the extent and frequency of processing, which may result also in a realisation of damage or interference with the rights and freedoms of the natural person. The supervisory authority should respond to the request for consultation within a specified period. However, the absence of a reaction of the supervisory authority within that period should be without prejudice to any intervention of the supervisory authority in accordance with its tasks and powers laid down in this Regulation, including the power to prohibit processing operations. As part of that consultation process, the outcome of a data protection impact assessment carried out with regard to the processing at issue may be submitted to the supervisory authority, in particular the measures envisaged to mitigate the risk to the rights and freedoms of natural persons. (95) The processor should assist the controller, where necessary and upon request, in ensuring compliance with the obligations deriving from the carrying out of data protection impact assessments and from prior consultation of the supervisory authority. (96) A consultation of the supervisory authority should also take place in the course of the preparation of a legislative or regulatory measure which provides for the processing of personal data, in order to ensure compliance of the intended processing with this Regulation and in particular to mitigate the risk involved for the data subject. (97) Where the processing is carried out by a public authority, except for courts or independent judicial authorities when acting in their judicial capacity, where, in the private sector, processing is carried out by a controller whose core activities consist of processing operations that require regular and systematic monitoring of the data subjects on a large scale, or where the core activities of the controller or the processor consist of processing on a large scale of special categories of personal data and data relating to criminal convictions and offences, a person with expert knowledge of data protection law and practices should assist the controller or processor to monitor internal compliance with this Regulation. In the private sector, the core activities of a controller relate to its primary activities and do not relate to the processing of personal data as ancillary activities. The necessary level of expert knowledge should be determined in particular according to the data processing operations carried out and the protection required for the personal data processed by the controller or the processor. Such data protection officers, whether or not they are an employee of the controller, should be in a position to perform their duties and tasks in an independent manner. (98) Associations or other bodies representing categories of controllers or processors should be encouraged to draw up codes of conduct, within the limits of this Regulation, so as to facilitate the effective application of this Regulation, taking account of the specific characteristics of the processing carried out in certain sectors and the specific needs of micro, small and medium enterprises. In particular, such codes of conduct could calibrate the obligations of controllers and processors, taking into account the risk likely to result from the processing for the rights and freedoms of natural persons. (99) When drawing up a code of conduct, or when amending or extending such a code, associations and other bodies representing categories of controllers or processors should consult relevant stakeholders, including data subjects where feasible, and have regard to submissions received and views expressed in response to such consultations. (100) In order to enhance transparency and compliance with this Regulation, the establishment of certification mechanisms and data protection seals and marks should be encouraged, allowing data subjects to quickly assess the level of data protection of relevant products and services. (101) Flows of personal data to and from countries outside the Union and international organisations are necessary for the expansion of international trade and international cooperation. The increase in such flows has raised new challenges and concerns with regard to the protection of personal data. However, when personal data are transferred from the Union to controllers, processors or other recipients in third countries or to international organisations, the level of protection of natural persons ensured in the Union by this Regulation should not be undermined, including in cases of onward transfers of personal data from the third country or international organisation to controllers, processors in the same or another third country or international organisation. In any event, transfers to third countries and international organisations may only be carried out in full compliance with this Regulation. A transfer could take place only if, subject to the other provisions of this Regulation, the conditions laid down in the provisions of this Regulation relating to the transfer of personal data to third countries or international organisations are complied with by the controller or processor. (102) This Regulation is without prejudice to international agreements concluded between the Union and third countries regulating the transfer of personal data including appropriate safeguards for the data subjects. Member States may conclude international agreements which involve the transfer of personal data to third countries or international organisations, as far as such agreements do not affect this Regulation or any other provisions of Union law and include an appropriate level of protection for the fundamental rights of the data subjects. (103) The Commission may decide with effect for the entire Union that a third country, a territory or specified sector within a third country, or an international organisation, offers an adequate level of data protection, thus providing legal certainty and uniformity throughout the Union as regards the third country or international organisation which is considered to provide such level of protection. In such cases, transfers of personal data to that third country or international organisation may take place without the need to obtain any further authorisation. The Commission may also decide, having given notice and a full statement setting out the reasons to the third country or international organisation, to revoke such a decision. (104) In line with the fundamental values on which the Union is founded, in particular the protection of human rights, the Commission should, in its assessment of the third country, or of a territory or specified sector within a third country, take into account how a particular third country respects the rule of law, access to justice as well as international human rights norms and standards and its general and sectoral law, including legislation concerning public security, defence and national security as well as public order and criminal law. The adoption of an adequacy decision with regard to a territory or a specified sector in a third country should take into account clear and objective criteria, such as specific processing activities and the scope of applicable legal standards and legislation in force in the third country. The third country should offer guarantees ensuring an adequate level of protection essentially equivalent to that ensured within the Union, in particular where personal data are processed in one or several specific sectors. In particular, the third country should ensure effective independent data protection supervision and should provide for cooperation mechanisms with the Member States' data protection authorities, and the data subjects should be provided with effective and enforceable rights and effective administrative and judicial redress. (105) Apart from the international commitments the third country or international organisation has entered into, the Commission should take account of obligations arising from the third country's or international organisation's participation in multilateral or regional systems in particular in relation to the protection of personal data, as well as the implementation of such obligations. In particular, the third country's accession to the Council of Europe Convention of 28 January 1981 for the Protection of Individuals with regard to the Automatic Processing of Personal Data and its Additional Protocol should be taken into account. The Commission should consult the Board when assessing the level of protection in third countries or international organisations. (106) The Commission should monitor the functioning of decisions on the level of protection in a third country, a territory or specified sector within a third country, or an international organisation, and monitor the functioning of decisions adopted on the basis of Article 25(6) or Article 26(4) of Directive 95/46/EC. In its adequacy decisions, the Commission should provide for a periodic review mechanism of their functioning. That periodic review should be conducted in consultation with the third country or international organisation in question and take into account all relevant developments in the third country or international organisation. For the purposes of monitoring and of carrying out the periodic reviews, the Commission should take into consideration the views and findings of the European Parliament and of the Council as well as of other relevant bodies and sources. The Commission should evaluate, within a reasonable time, the functioning of the latter decisions and report any relevant findings to the Committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council (12) as established under this Regulation, to the European Parliament and to the Council. (107) The Commission may recognise that a third country, a territory or a specified sector within a third country, or an international organisation no longer ensures an adequate level of data protection. Consequently the transfer of personal data to that third country or international organisation should be prohibited, unless the requirements in this Regulation relating to transfers subject to appropriate safeguards, including binding corporate rules, and derogations for specific situations are fulfilled. In that case, provision should be made for consultations between the Commission and such third countries or international organisations. The Commission should, in a timely manner, inform the third country or international organisation of the reasons and enter into consultations with it in order to remedy the situation. (108) In the absence of an adequacy decision, the controller or processor should take measures to compensate for the lack of data protection in a third country by way of appropriate safeguards for the data subject. Such appropriate safeguards may consist of making use of binding corporate rules, standard data protection clauses adopted by the Commission, standard data protection clauses adopted by a supervisory authority or contractual clauses authorised by a supervisory authority. Those safeguards should ensure compliance with data protection requirements and the rights of the data subjects appropriate to processing within the Union, including the availability of enforceable data subject rights and of effective legal remedies, including to obtain effective administrative or judicial redress and to claim compensation, in the Union or in a third country. They should relate in particular to compliance with the general principles relating to personal data processing, the principles of data protection by design and by default. Transfers may also be carried out by public authorities or bodies with public authorities or bodies in third countries or with international organisations with corresponding duties or functions, including on the basis of provisions to be inserted into administrative arrangements, such as a memorandum of understanding, providing for enforceable and effective rights for data subjects. Authorisation by the competent supervisory authority should be obtained when the safeguards are provided for in administrative arrangements that are not legally binding. (109) The possibility for the controller or processor to use standard data-protection clauses adopted by the Commission or by a supervisory authority should prevent controllers or processors neither from including the standard data-protection clauses in a wider contract, such as a contract between the processor and another processor, nor from adding other clauses or additional safeguards provided that they do not contradict, directly or indirectly, the standard contractual clauses adopted by the Commission or by a supervisory authority or prejudice the fundamental rights or freedoms of the data subjects. Controllers and processors should be encouraged to provide additional safeguards via contractual commitments that supplement standard protection clauses. (110) A group of undertakings, or a group of enterprises engaged in a joint economic activity, should be able to make use of approved binding corporate rules for its international transfers from the Union to organisations within the same group of undertakings, or group of enterprises engaged in a joint economic activity, provided that such corporate rules include all essential principles and enforceable rights to ensure appropriate safeguards for transfers or categories of transfers of personal data. (111) Provisions should be made for the possibility for transfers in certain circumstances where the data subject has given his or her explicit consent, where the transfer is occasional and necessary in relation to a contract or a legal claim, regardless of whether in a judicial procedure or whether in an administrative or any out-of-court procedure, including procedures before regulatory bodies. Provision should also be made for the possibility for transfers where important grounds of public interest laid down by Union or Member State law so require or where the transfer is made from a register established by law and intended for consultation by the public or persons having a legitimate interest. In the latter case, such a transfer should not involve the entirety of the personal data or entire categories of the data contained in the register and, when the register is intended for consultation by persons having a legitimate interest, the transfer should be made only at the request of those persons or, if they are to be the recipients, taking into full account the interests and fundamental rights of the data subject. (112) Those derogations should in particular apply to data transfers required and necessary for important reasons of public interest, for example in cases of international data exchange between competition authorities, tax or customs administrations, between financial supervisory authorities, between services competent for social security matters, or for public health, for example in the case of contact tracing for contagious diseases or in order to reduce and/or eliminate doping in sport. A transfer of personal data should also be regarded as lawful where it is necessary to protect an interest which is essential for the data subject's or another person's vital interests, including physical integrity or life, if the data subject is incapable of giving consent. In the absence of an adequacy decision, Union or Member State law may, for important reasons of public interest, expressly set limits to the transfer of specific categories of data to a third country or an international organisation. Member States should notify such provisions to the Commission. Any transfer to an international humanitarian organisation of personal data of a data subject who is physically or legally incapable of giving consent, with a view to accomplishing a task incumbent under the Geneva Conventions or to complying with international humanitarian law applicable in armed conflicts, could be considered to be necessary for an important reason of public interest or because it is in the vital interest of the data subject. (113) Transfers which can be qualified as not repetitive and that only concern a limited number of data subjects, could also be possible for the purposes of the compelling legitimate interests pursued by the controller, when those interests are not overridden by the interests or rights and freedoms of the data subject and when the controller has assessed all the circumstances surrounding the data transfer. The controller should give particular consideration to the nature of the personal data, the purpose and duration of the proposed processing operation or operations, as well as the situation in the country of origin, the third country and the country of final destination, and should provide suitable safeguards to protect fundamental rights and freedoms of natural persons with regard to the processing of their personal data. Such transfers should be possible only in residual cases where none of the other grounds for transfer are applicable. For scientific or historical research purposes or statistical purposes, the legitimate expectations of society for an increase of knowledge should be taken into consideration. The controller should inform the supervisory authority and the data subject about the transfer. (114) In any case, where the Commission has taken no decision on the adequate level of data protection in a third country, the controller or processor should make use of solutions that provide data subjects with enforceable and effective rights as regards the processing of their data in the Union once those data have been transferred so that that they will continue to benefit from fundamental rights and safeguards. (115) Some third countries adopt laws, regulations and other legal acts which purport to directly regulate the processing activities of natural and legal persons under the jurisdiction of the Member States. This may include judgments of courts or tribunals or decisions of administrative authorities in third countries requiring a controller or processor to transfer or disclose personal data, and which are not based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State. The extraterritorial application of those laws, regulations and other legal acts may be in breach of international law and may impede the attainment of the protection of natural persons ensured in the Union by this Regulation. Transfers should only be allowed where the conditions of this Regulation for a transfer to third countries are met. This may be the case, inter alia, where disclosure is necessary for an important ground of public interest recognised in Union or Member State law to which the controller is subject. (116) When personal data moves across borders outside the Union it may put at increased risk the ability of natural persons to exercise data protection rights in particular to protect themselves from the unlawful use or disclosure of that information. At the same time, supervisory authorities may find that they are unable to pursue complaints or conduct investigations relating to the activities outside their borders. Their efforts to work together in the cross-border context may also be hampered by insufficient preventative or remedial powers, inconsistent legal regimes, and practical obstacles like resource constraints. Therefore, there is a need to promote closer cooperation among data protection supervisory authorities to help them exchange information and carry out investigations with their international counterparts. For the purposes of developing international cooperation mechanisms to facilitate and provide international mutual assistance for the enforcement of legislation for the protection of personal data, the Commission and the supervisory authorities should exchange information and cooperate in activities related to the exercise of their powers with competent authorities in third countries, based on reciprocity and in accordance with this Regulation. (117) The establishment of supervisory authorities in Member States, empowered to perform their tasks and exercise their powers with complete independence, is an essential component of the protection of natural persons with regard to the processing of their personal data. Member States should be able to establish more than one supervisory authority, to reflect their constitutional, organisational and administrative structure. (118) The independence of supervisory authorities should not mean that the supervisory authorities cannot be subject to control or monitoring mechanisms regarding their financial expenditure or to judicial review. (119) Where a Member State establishes several supervisory authorities, it should establish by law mechanisms for ensuring the effective participation of those supervisory authorities in the consistency mechanism. That Member State should in particular designate the supervisory authority which functions as a single contact point for the effective participation of those authorities in the mechanism, to ensure swift and smooth cooperation with other supervisory authorities, the Board and the Commission. (120) Each supervisory authority should be provided with the financial and human resources, premises and infrastructure necessary for the effective performance of their tasks, including those related to mutual assistance and cooperation with other supervisory authorities throughout the Union. Each supervisory authority should have a separate, public annual budget, which may be part of the overall state or national budget. (121) The general conditions for the member or members of the supervisory authority should be laid down by law in each Member State and should in particular provide that those members are to be appointed, by means of a transparent procedure, either by the parliament, government or the head of State of the Member State on the basis of a proposal from the government, a member of the government, the parliament or a chamber of the parliament, or by an independent body entrusted under Member State law. In order to ensure the independence of the supervisory authority, the member or members should act with integrity, refrain from any action that is incompatible with their duties and should not, during their term of office, engage in any incompatible occupation, whether gainful or not. The supervisory authority should have its own staff, chosen by the supervisory authority or an independent body established by Member State law, which should be subject to the exclusive direction of the member or members of the supervisory authority. (122) Each supervisory authority should be competent on the territory of its own Member State to exercise the powers and to perform the tasks conferred on it in accordance with this Regulation. This should cover in particular the processing in the context of the activities of an establishment of the controller or processor on the territory of its own Member State, the processing of personal data carried out by public authorities or private bodies acting in the public interest, processing affecting data subjects on its territory or processing carried out by a controller or processor not established in the Union when targeting data subjects residing on its territory. This should include handling complaints lodged by a data subject, conducting investigations on the application of this Regulation and promoting public awareness of the risks, rules, safeguards and rights in relation to the processing of personal data. (123) The supervisory authorities should monitor the application of the provisions pursuant to this Regulation and contribute to its consistent application throughout the Union, in order to protect natural persons in relation to the processing of their personal data and to facilitate the free flow of personal data within the internal market. For that purpose, the supervisory authorities should cooperate with each other and with the Commission, without the need for any agreement between Member States on the provision of mutual assistance or on such cooperation. (124) Where the processing of personal data takes place in the context of the activities of an establishment of a controller or a processor in the Union and the controller or processor is established in more than one Member State, or where processing taking place in the context of the activities of a single establishment of a controller or processor in the Union substantially affects or is likely to substantially affect data subjects in more than one Member State, the supervisory authority for the main establishment of the controller or processor or for the single establishment of the controller or processor should act as lead authority. It should cooperate with the other authorities concerned, because the controller or processor has an establishment on the territory of their Member State, because data subjects residing on their territory are substantially affected, or because a complaint has been lodged with them. Also where a data subject not residing in that Member State has lodged a complaint, the supervisory authority with which such complaint has been lodged should also be a supervisory authority concerned. Within its tasks to issue guidelines on any question covering the application of this Regulation, the Board should be able to issue guidelines in particular on the criteria to be taken into account in order to ascertain whether the processing in question substantially affects data subjects in more than one Member State and on what constitutes a relevant and reasoned objection. (125) The lead authority should be competent to adopt binding decisions regarding measures applying the powers conferred on it in accordance with this Regulation. In its capacity as lead authority, the supervisory authority should closely involve and coordinate the supervisory authorities concerned in the decision-making process. Where the decision is to reject the complaint by the data subject in whole or in part, that decision should be adopted by the supervisory authority with which the complaint has been lodged. (126) The decision should be agreed jointly by the lead supervisory authority and the supervisory authorities concerned and should be directed towards the main or single establishment of the controller or processor and be binding on the controller and processor. The controller or processor should take the necessary measures to ensure compliance with this Regulation and the implementation of the decision notified by the lead supervisory authority to the main establishment of the controller or processor as regards the processing activities in the Union. (127) Each supervisory authority not acting as the lead supervisory authority should be competent to handle local cases where the controller or processor is established in more than one Member State, but the subject matter of the specific processing concerns only processing carried out in a single Member State and involves only data subjects in that single Member State, for example, where the subject matter concerns the processing of employees' personal data in the specific employment context of a Member State. In such cases, the supervisory authority should inform the lead supervisory authority without delay about the matter. After being informed, the lead supervisory authority should decide, whether it will handle the case pursuant to the provision on cooperation between the lead supervisory authority and other supervisory authorities concerned (\u2018one-stop-shop mechanism\u2019), or whether the supervisory authority which informed it should handle the case at local level. When deciding whether it will handle the case, the lead supervisory authority should take into account whether there is an establishment of the controller or processor in the Member State of the supervisory authority which informed it in order to ensure effective enforcement of a decision vis-\u00e0-vis the controller or processor. Where the lead supervisory authority decides to handle the case, the supervisory authority which informed it should have the possibility to submit a draft for a decision, of which the lead supervisory authority should take utmost account when preparing its draft decision in that one-stop-shop mechanism. (128) The rules on the lead supervisory authority and the one-stop-shop mechanism should not apply where the processing is carried out by public authorities or private bodies in the public interest. In such cases the only supervisory authority competent to exercise the powers conferred to it in accordance with this Regulation should be the supervisory authority of the Member State where the public authority or private body is established. (129) In order to ensure consistent monitoring and enforcement of this Regulation throughout the Union, the supervisory authorities should have in each Member State the same tasks and effective powers, including powers of investigation, corrective powers and sanctions, and authorisation and advisory powers, in particular in cases of complaints from natural persons, and without prejudice to the powers of prosecutorial authorities under Member State law, to bring infringements of this Regulation to the attention of the judicial authorities and engage in legal proceedings. Such powers should also include the power to impose a temporary or definitive limitation, including a ban, on processing. Member States may specify other tasks related to the protection of personal data under this Regulation. The powers of supervisory authorities should be exercised in accordance with appropriate procedural safeguards set out in Union and Member State law, impartially, fairly and within a reasonable time. In particular each measure should be appropriate, necessary and proportionate in view of ensuring compliance with this Regulation, taking into account the circumstances of each individual case, respect the right of every person to be heard before any individual measure which would affect him or her adversely is taken and avoid superfluous costs and excessive inconveniences for the persons concerned. Investigatory powers as regards access to premises should be exercised in accordance with specific requirements in Member State procedural law, such as the requirement to obtain a prior judicial authorisation. Each legally binding measure of the supervisory authority should be in writing, be clear and unambiguous, indicate the supervisory authority which has issued the measure, the date of issue of the measure, bear the signature of the head, or a member of the supervisory authority authorised by him or her, give the reasons for the measure, and refer to the right of an effective remedy. This should not preclude additional requirements pursuant to Member State procedural law. The adoption of a legally binding decision implies that it may give rise to judicial review in the Member State of the supervisory authority that adopted the decision. (130) Where the supervisory authority with which the complaint has been lodged is not the lead supervisory authority, the lead supervisory authority should closely cooperate with the supervisory authority with which the complaint has been lodged in accordance with the provisions on cooperation and consistency laid down in this Regulation. In such cases, the lead supervisory authority should, when taking measures intended to produce legal effects, including the imposition of administrative fines, take utmost account of the view of the supervisory authority with which the complaint has been lodged and which should remain competent to carry out any investigation on the territory of its own Member State in liaison with the competent supervisory authority. (131) Where another supervisory authority should act as a lead supervisory authority for the processing activities of the controller or processor but the concrete subject matter of a complaint or the possible infringement concerns only processing activities of the controller or processor in the Member State where the complaint has been lodged or the possible infringement detected and the matter does not substantially affect or is not likely to substantially affect data subjects in other Member States, the supervisory authority receiving a complaint or detecting or being informed otherwise of situations that entail possible infringements of this Regulation should seek an amicable settlement with the controller and, if this proves unsuccessful, exercise its full range of powers. This should include: specific processing carried out in the territory of the Member State of the supervisory authority or with regard to data subjects on the territory of that Member State; processing that is carried out in the context of an offer of goods or services specifically aimed at data subjects in the territory of the Member State of the supervisory authority; or processing that has to be assessed taking into account relevant legal obligations under Member State law. (132) Awareness-raising activities by supervisory authorities addressed to the public should include specific measures directed at controllers and processors, including micro, small and medium-sized enterprises, as well as natural persons in particular in the educational context. (133) The supervisory authorities should assist each other in performing their tasks and provide mutual assistance, so as to ensure the consistent application and enforcement of this Regulation in the internal market. A supervisory authority requesting mutual assistance may adopt a provisional measure if it receives no response to a request for mutual assistance within one month of the receipt of that request by the other supervisory authority. (134) Each supervisory authority should, where appropriate, participate in joint operations with other supervisory authorities. The requested supervisory authority should be obliged to respond to the request within a specified time period. (135) In order to ensure the consistent application of this Regulation throughout the Union, a consistency mechanism for cooperation between the supervisory authorities should be established. That mechanism should in particular apply where a supervisory authority intends to adopt a measure intended to produce legal effects as regards processing operations which substantially affect a significant number of data subjects in several Member States. It should also apply where any supervisory authority concerned or the Commission requests that such matter should be handled in the consistency mechanism. That mechanism should be without prejudice to any measures that the Commission may take in the exercise of its powers under the Treaties. (136) In applying the consistency mechanism, the Board should, within a determined period of time, issue an opinion, if a majority of its members so decides or if so requested by any supervisory authority concerned or the Commission. The Board should also be empowered to adopt legally binding decisions where there are disputes between supervisory authorities. For that purpose, it should issue, in principle by a two-thirds majority of its members, legally binding decisions in clearly specified cases where there are conflicting views among supervisory authorities, in particular in the cooperation mechanism between the lead supervisory authority and supervisory authorities concerned on the merits of the case, in particular whether there is an infringement of this Regulation. (137) There may be an urgent need to act in order to protect the rights and freedoms of data subjects, in particular when the danger exists that the enforcement of a right of a data subject could be considerably impeded. A supervisory authority should therefore be able to adopt duly justified provisional measures on its territory with a specified period of validity which should not exceed three months. (138) The application of such mechanism should be a condition for the lawfulness of a measure intended to produce legal effects by a supervisory authority in those cases where its application is mandatory. In other cases of cross-border relevance, the cooperation mechanism between the lead supervisory authority and supervisory authorities concerned should be applied and mutual assistance and joint operations might be carried out between the supervisory authorities concerned on a bilateral or multilateral basis without triggering the consistency mechanism. (139) In order to promote the consistent application of this Regulation, the Board should be set up as an independent body of the Union. To fulfil its objectives, the Board should have legal personality. The Board should be represented by its Chair. It should replace the Working Party on the Protection of Individuals with Regard to the Processing of Personal Data established by Directive 95/46/EC. It should consist of the head of a supervisory authority of each Member State and the European Data Protection Supervisor or their respective representatives. The Commission should participate in the Board's activities without voting rights and the European Data Protection Supervisor should have specific voting rights. The Board should contribute to the consistent application of this Regulation throughout the Union, including by advising the Commission, in particular on the level of protection in third countries or international organisations, and promoting cooperation of the supervisory authorities throughout the Union. The Board should act independently when performing its tasks. (140) The Board should be assisted by a secretariat provided by the European Data Protection Supervisor. The staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this Regulation should perform its tasks exclusively under the instructions of, and report to, the Chair of the Board. (141) Every data subject should have the right to lodge a complaint with a single supervisory authority, in particular in the Member State of his or her habitual residence, and the right to an effective judicial remedy in accordance with Article 47 of the Charter if the data subject considers that his or her rights under this Regulation are infringed or where the supervisory authority does not act on a complaint, partially or wholly rejects or dismisses a complaint or does not act where such action is necessary to protect the rights of the data subject. The investigation following a complaint should be carried out, subject to judicial review, to the extent that is appropriate in the specific case. The supervisory authority should inform the data subject of the progress and the outcome of the complaint within a reasonable period. If the case requires further investigation or coordination with another supervisory authority, intermediate information should be given to the data subject. In order to facilitate the submission of complaints, each supervisory authority should take measures such as providing a complaint submission form which can also be completed electronically, without excluding other means of communication. (142) Where a data subject considers that his or her rights under this Regulation are infringed, he or she should have the right to mandate a not-for-profit body, organisation or association which is constituted in accordance with the law of a Member State, has statutory objectives which are in the public interest and is active in the field of the protection of personal data to lodge a complaint on his or her behalf with a supervisory authority, exercise the right to a judicial remedy on behalf of data subjects or, if provided for in Member State law, exercise the right to receive compensation on behalf of data subjects. A Member State may provide for such a body, organisation or association to have the right to lodge a complaint in that Member State, independently of a data subject's mandate, and the right to an effective judicial remedy where it has reasons to consider that the rights of a data subject have been infringed as a result of the processing of personal data which infringes this Regulation. That body, organisation or association may not be allowed to claim compensation on a data subject's behalf independently of the data subject's mandate. (143) Any natural or legal person has the right to bring an action for annulment of decisions of the Board before the Court of Justice under the conditions provided for in Article 263 TFEU. As addressees of such decisions, the supervisory authorities concerned which wish to challenge them have to bring action within two months of being notified of them, in accordance with Article 263 TFEU. Where decisions of the Board are of direct and individual concern to a controller, processor or complainant, the latter may bring an action for annulment against those decisions within two months of their publication on the website of the Board, in accordance with Article 263 TFEU. Without prejudice to this right under Article 263 TFEU, each natural or legal person should have an effective judicial remedy before the competent national court against a decision of a supervisory authority which produces legal effects concerning that person. Such a decision concerns in particular the exercise of investigative, corrective and authorisation powers by the supervisory authority or the dismissal or rejection of complaints. However, the right to an effective judicial remedy does not encompass measures taken by supervisory authorities which are not legally binding, such as opinions issued by or advice provided by the supervisory authority. Proceedings against a supervisory authority should be brought before the courts of the Member State where the supervisory authority is established and should be conducted in accordance with that Member State's procedural law. Those courts should exercise full jurisdiction, which should include jurisdiction to examine all questions of fact and law relevant to the dispute before them. Where a complaint has been rejected or dismissed by a supervisory authority, the complainant may bring proceedings before the courts in the same Member State. In the context of judicial remedies relating to the application of this Regulation, national courts which consider a decision on the question necessary to enable them to give judgment, may, or in the case provided for in Article 267 TFEU, must, request the Court of Justice to give a preliminary ruling on the interpretation of Union law, including this Regulation. Furthermore, where a decision of a supervisory authority implementing a decision of the Board is challenged before a national court and the validity of the decision of the Board is at issue, that national court does not have the power to declare the Board's decision invalid but must refer the question of validity to the Court of Justice in accordance with Article 267 TFEU as interpreted by the Court of Justice, where it considers the decision invalid. However, a national court may not refer a question on the validity of the decision of the Board at the request of a natural or legal person which had the opportunity to bring an action for annulment of that decision, in particular if it was directly and individually concerned by that decision, but had not done so within the period laid down in Article 263 TFEU. (144) Where a court seized of proceedings against a decision by a supervisory authority has reason to believe that proceedings concerning the same processing, such as the same subject matter as regards processing by the same controller or processor, or the same cause of action, are brought before a competent court in another Member State, it should contact that court in order to confirm the existence of such related proceedings. If related proceedings are pending before a court in another Member State, any court other than the court first seized may stay its proceedings or may, on request of one of the parties, decline jurisdiction in favour of the court first seized if that court has jurisdiction over the proceedings in question and its law permits the consolidation of such related proceedings. Proceedings are deemed to be related where they are so closely connected that it is expedient to hear and determine them together in order to avoid the risk of irreconcilable judgments resulting from separate proceedings. (145) For proceedings against a controller or processor, the plaintiff should have the choice to bring the action before the courts of the Member States where the controller or processor has an establishment or where the data subject resides, unless the controller is a public authority of a Member State acting in the exercise of its public powers. (146) The controller or processor should compensate any damage which a person may suffer as a result of processing that infringes this Regulation. The controller or processor should be exempt from liability if it proves that it is not in any way responsible for the damage. The concept of damage should be broadly interpreted in the light of the case-law of the Court of Justice in a manner which fully reflects the objectives of this Regulation. This is without prejudice to any claims for damage deriving from the violation of other rules in Union or Member State law. Processing that infringes this Regulation also includes processing that infringes delegated and implementing acts adopted in accordance with this Regulation and Member State law specifying rules of this Regulation. Data subjects should receive full and effective compensation for the damage they have suffered. Where controllers or processors are involved in the same processing, each controller or processor should be held liable for the entire damage. However, where they are joined to the same judicial proceedings, in accordance with Member State law, compensation may be apportioned according to the responsibility of each controller or processor for the damage caused by the processing, provided that full and effective compensation of the data subject who suffered the damage is ensured. Any controller or processor which has paid full compensation may subsequently institute recourse proceedings against other controllers or processors involved in the same processing. (147) Where specific rules on jurisdiction are contained in this Regulation, in particular as regards proceedings seeking a judicial remedy including compensation, against a controller or processor, general jurisdiction rules such as those of Regulation (EU) No 1215/2012 of the European Parliament and of the Council (13) should not prejudice the application of such specific rules. (148) In order to strengthen the enforcement of the rules of this Regulation, penalties including administrative fines should be imposed for any infringement of this Regulation, in addition to, or instead of appropriate measures imposed by the supervisory authority pursuant to this Regulation. In a case of a minor infringement or if the fine likely to be imposed would constitute a disproportionate burden to a natural person, a reprimand may be issued instead of a fine. Due regard should however be given to the nature, gravity and duration of the infringement, the intentional character of the infringement, actions taken to mitigate the damage suffered, degree of responsibility or any relevant previous infringements, the manner in which the infringement became known to the supervisory authority, compliance with measures ordered against the controller or processor, adherence to a code of conduct and any other aggravating or mitigating factor. The imposition of penalties including administrative fines should be subject to appropriate procedural safeguards in accordance with the general principles of Union law and the Charter, including effective judicial protection and due process. (149) Member States should be able to lay down the rules on criminal penalties for infringements of this Regulation, including for infringements of national rules adopted pursuant to and within the limits of this Regulation. Those criminal penalties may also allow for the deprivation of the profits obtained through infringements of this Regulation. However, the imposition of criminal penalties for infringements of such national rules and of administrative penalties should not lead to a breach of the principle of ne bis in idem, as interpreted by the Court of Justice. (150) In order to strengthen and harmonise administrative penalties for infringements of this Regulation, each supervisory authority should have the power to impose administrative fines. This Regulation should indicate infringements and the upper limit and criteria for setting the related administrative fines, which should be determined by the competent supervisory authority in each individual case, taking into account all relevant circumstances of the specific situation, with due regard in particular to the nature, gravity and duration of the infringement and of its consequences and the measures taken to ensure compliance with the obligations under this Regulation and to prevent or mitigate the consequences of the infringement. Where administrative fines are imposed on an undertaking, an undertaking should be understood to be an undertaking in accordance with Articles 101 and 102 TFEU for those purposes. Where administrative fines are imposed on persons that are not an undertaking, the supervisory authority should take account of the general level of income in the Member State as well as the economic situation of the person in considering the appropriate amount of the fine. The consistency mechanism may also be used to promote a consistent application of administrative fines. It should be for the Member States to determine whether and to which extent public authorities should be subject to administrative fines. Imposing an administrative fine or giving a warning does not affect the application of other powers of the supervisory authorities or of other penalties under this Regulation. (151) The legal systems of Denmark and Estonia do not allow for administrative fines as set out in this Regulation. The rules on administrative fines may be applied in such a manner that in Denmark the fine is imposed by competent national courts as a criminal penalty and in Estonia the fine is imposed by the supervisory authority in the framework of a misdemeanour procedure, provided that such an application of the rules in those Member States has an equivalent effect to administrative fines imposed by supervisory authorities. Therefore the competent national courts should take into account the recommendation by the supervisory authority initiating the fine. In any event, the fines imposed should be effective, proportionate and dissuasive. (152) Where this Regulation does not harmonise administrative penalties or where necessary in other cases, for example in cases of serious infringements of this Regulation, Member States should implement a system which provides for effective, proportionate and dissuasive penalties. The nature of such penalties, criminal or administrative, should be determined by Member State law. (153) Member States law should reconcile the rules governing freedom of expression and information, including journalistic, academic, artistic and or literary expression with the right to the protection of personal data pursuant to this Regulation. The processing of personal data solely for journalistic purposes, or for the purposes of academic, artistic or literary expression should be subject to derogations or exemptions from certain provisions of this Regulation if necessary to reconcile the right to the protection of personal data with the right to freedom of expression and information, as enshrined in Article 11 of the Charter. This should apply in particular to the processing of personal data in the audiovisual field and in news archives and press libraries. Therefore, Member States should adopt legislative measures which lay down the exemptions and derogations necessary for the purpose of balancing those fundamental rights. Member States should adopt such exemptions and derogations on general principles, the rights of the data subject, the controller and the processor, the transfer of personal data to third countries or international organisations, the independent supervisory authorities, cooperation and consistency, and specific data-processing situations. Where such exemptions or derogations differ from one Member State to another, the law of the Member State to which the controller is subject should apply. In order to take account of the importance of the right to freedom of expression in every democratic society, it is necessary to interpret notions relating to that freedom, such as journalism, broadly. (154) This Regulation allows the principle of public access to official documents to be taken into account when applying this Regulation. Public access to official documents may be considered to be in the public interest. Personal data in documents held by a public authority or a public body should be able to be publicly disclosed by that authority or body if the disclosure is provided for by Union or Member State law to which the public authority or public body is subject. Such laws should reconcile public access to official documents and the reuse of public sector information with the right to the protection of personal data and may therefore provide for the necessary reconciliation with the right to the protection of personal data pursuant to this Regulation. The reference to public authorities and bodies should in that context include all authorities or other bodies covered by Member State law on public access to documents. Directive 2003/98/EC of the European Parliament and of the Council (14) leaves intact and in no way affects the level of protection of natural persons with regard to the processing of personal data under the provisions of Union and Member State law, and in particular does not alter the obligations and rights set out in this Regulation. In particular, that Directive should not apply to documents to which access is excluded or restricted by virtue of the access regimes on the grounds of protection of personal data, and parts of documents accessible by virtue of those regimes which contain personal data the re-use of which has been provided for by law as being incompatible with the law concerning the protection of natural persons with regard to the processing of personal data. (155) Member State law or collective agreements, including \u2018works agreements\u2019, may provide for specific rules on the processing of employees' personal data in the employment context, in particular for the conditions under which personal data in the employment context may be processed on the basis of the consent of the employee, the purposes of the recruitment, the performance of the contract of employment, including discharge of obligations laid down by law or by collective agreements, management, planning and organisation of work, equality and diversity in the workplace, health and safety at work, and for the purposes of the exercise and enjoyment, on an individual or collective basis, of rights and benefits related to employment, and for the purpose of the termination of the employment relationship. (156) The processing of personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes should be subject to appropriate safeguards for the rights and freedoms of the data subject pursuant to this Regulation. Those safeguards should ensure that technical and organisational measures are in place in order to ensure, in particular, the principle of data minimisation. The further processing of personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes is to be carried out when the controller has assessed the feasibility to fulfil those purposes by processing data which do not permit or no longer permit the identification of data subjects, provided that appropriate safeguards exist (such as, for instance, pseudonymisation of the data). Member States should provide for appropriate safeguards for the processing of personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. Member States should be authorised to provide, under specific conditions and subject to appropriate safeguards for data subjects, specifications and derogations with regard to the information requirements and rights to rectification, to erasure, to be forgotten, to restriction of processing, to data portability, and to object when processing personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. The conditions and safeguards in question may entail specific procedures for data subjects to exercise those rights if this is appropriate in the light of the purposes sought by the specific processing along with technical and organisational measures aimed at minimising the processing of personal data in pursuance of the proportionality and necessity principles. The processing of personal data for scientific purposes should also comply with other relevant legislation such as on clinical trials. (157) By coupling information from registries, researchers can obtain new knowledge of great value with regard to widespread medical conditions such as cardiovascular disease, cancer and depression. On the basis of registries, research results can be enhanced, as they draw on a larger population. Within social science, research on the basis of registries enables researchers to obtain essential knowledge about the long-term correlation of a number of social conditions such as unemployment and education with other life conditions. Research results obtained through registries provide solid, high-quality knowledge which can provide the basis for the formulation and implementation of knowledge-based policy, improve the quality of life for a number of people and improve the efficiency of social services. In order to facilitate scientific research, personal data can be processed for scientific research purposes, subject to appropriate conditions and safeguards set out in Union or Member State law. (158) Where personal data are processed for archiving purposes, this Regulation should also apply to that processing, bearing in mind that this Regulation should not apply to deceased persons. Public authorities or public or private bodies that hold records of public interest should be services which, pursuant to Union or Member State law, have a legal obligation to acquire, preserve, appraise, arrange, describe, communicate, promote, disseminate and provide access to records of enduring value for general public interest. Member States should also be authorised to provide for the further processing of personal data for archiving purposes, for example with a view to providing specific information related to the political behaviour under former totalitarian state regimes, genocide, crimes against humanity, in particular the Holocaust, or war crimes. (159) Where personal data are processed for scientific research purposes, this Regulation should also apply to that processing. For the purposes of this Regulation, the processing of personal data for scientific research purposes should be interpreted in a broad manner including for example technological development and demonstration, fundamental research, applied research and privately funded research. In addition, it should take into account the Union's objective under Article 179(1) TFEU of achieving a European Research Area. Scientific research purposes should also include studies conducted in the public interest in the area of public health. To meet the specificities of processing personal data for scientific research purposes, specific conditions should apply in particular as regards the publication or otherwise disclosure of personal data in the context of scientific research purposes. If the result of scientific research in particular in the health context gives reason for further measures in the interest of the data subject, the general rules of this Regulation should apply in view of those measures. (160) Where personal data are processed for historical research purposes, this Regulation should also apply to that processing. This should also include historical research and research for genealogical purposes, bearing in mind that this Regulation should not apply to deceased persons. (161) For the purpose of consenting to the participation in scientific research activities in clinical trials, the relevant provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council (15) should apply. (162) Where personal data are processed for statistical purposes, this Regulation should apply to that processing. Union or Member State law should, within the limits of this Regulation, determine statistical content, control of access, specifications for the processing of personal data for statistical purposes and appropriate measures to safeguard the rights and freedoms of the data subject and for ensuring statistical confidentiality. Statistical purposes mean any operation of collection and the processing of personal data necessary for statistical surveys or for the production of statistical results. Those statistical results may further be used for different purposes, including a scientific research purpose. The statistical purpose implies that the result of processing for statistical purposes is not personal data, but aggregate data, and that this result or the personal data are not used in support of measures or decisions regarding any particular natural person. (163) The confidential information which the Union and national statistical authorities collect for the production of official European and official national statistics should be protected. European statistics should be developed, produced and disseminated in accordance with the statistical principles as set out in Article 338(2) TFEU, while national statistics should also comply with Member State law. Regulation (EC) No 223/2009 of the European Parliament and of the Council (16) provides further specifications on statistical confidentiality for European statistics. (164) As regards the powers of the supervisory authorities to obtain from the controller or processor access to personal data and access to their premises, Member States may adopt by law, within the limits of this Regulation, specific rules in order to safeguard the professional or other equivalent secrecy obligations, in so far as necessary to reconcile the right to the protection of personal data with an obligation of professional secrecy. This is without prejudice to existing Member State obligations to adopt rules on professional secrecy where required by Union law. (165) This Regulation respects and does not prejudice the status under existing constitutional law of churches and religious associations or communities in the Member States, as recognised in Article 17 TFEU. (166) In order to fulfil the objectives of this Regulation, namely to protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data and to ensure the free movement of personal data within the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. In particular, delegated acts should be adopted in respect of criteria and requirements for certification mechanisms, information to be presented by standardised icons and procedures for providing such icons. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (167) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission when provided for by this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. In that context, the Commission should consider specific measures for micro, small and medium-sized enterprises. (168) The examination procedure should be used for the adoption of implementing acts on standard contractual clauses between controllers and processors and between processors; codes of conduct; technical standards and mechanisms for certification; the adequate level of protection afforded by a third country, a territory or a specified sector within that third country, or an international organisation; standard protection clauses; formats and procedures for the exchange of information by electronic means between controllers, processors and supervisory authorities for binding corporate rules; mutual assistance; and arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board. (169) The Commission should adopt immediately applicable implementing acts where available evidence reveals that a third country, a territory or a specified sector within that third country, or an international organisation does not ensure an adequate level of protection, and imperative grounds of urgency so require. (170) Since the objective of this Regulation, namely to ensure an equivalent level of protection of natural persons and the free flow of personal data throughout the Union, cannot be sufficiently achieved by the Member States and can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (171) Directive 95/46/EC should be repealed by this Regulation. Processing already under way on the date of application of this Regulation should be brought into conformity with this Regulation within the period of two years after which this Regulation enters into force. Where processing is based on consent pursuant to Directive 95/46/EC, it is not necessary for the data subject to give his or her consent again if the manner in which the consent has been given is in line with the conditions of this Regulation, so as to allow the controller to continue such processing after the date of application of this Regulation. Commission decisions adopted and authorisations by supervisory authorities based on Directive 95/46/EC remain in force until amended, replaced or repealed. (172) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 7 March 2012 (17). (173) This Regulation should apply to all matters concerning the protection of fundamental rights and freedoms vis-\u00e0-vis the processing of personal data which are not subject to specific obligations with the same objective set out in Directive 2002/58/EC of the European Parliament and of the Council (18), including the obligations on the controller and the rights of natural persons. In order to clarify the relationship between this Regulation and Directive 2002/58/EC, that Directive should be amended accordingly. Once this Regulation is adopted, Directive 2002/58/EC should be reviewed in particular in order to ensure consistency with this Regulation, HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject-matter and objectives 1. This Regulation lays down rules relating to the protection of natural persons with regard to the processing of personal data and rules relating to the free movement of personal data. 2. This Regulation protects fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data. 3. The free movement of personal data within the Union shall be neither restricted nor prohibited for reasons connected with the protection of natural persons with regard to the processing of personal data. Article 2 Material scope 1. This Regulation applies to the processing of personal data wholly or partly by automated means and to the processing other than by automated means of personal data which form part of a filing system or are intended to form part of a filing system. 2. This Regulation does not apply to the processing of personal data: (a) in the course of an activity which falls outside the scope of Union law; (b) by the Member States when carrying out activities which fall within the scope of Chapter 2 of Title V of the TEU; (c) by a natural person in the course of a purely personal or household activity; (d) by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security. 3. For the processing of personal data by the Union institutions, bodies, offices and agencies, Regulation (EC) No 45/2001 applies. Regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal data shall be adapted to the principles and rules of this Regulation in accordance with Article 98. 4. This Regulation shall be without prejudice to the application of Directive 2000/31/EC, in particular of the liability rules of intermediary service providers in Articles 12 to 15 of that Directive. Article 3 Territorial scope 1. This Regulation applies to the processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union, regardless of whether the processing takes place in the Union or not. 2. This Regulation applies to the processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union, where the processing activities are related to: (a) the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union; or (b) the monitoring of their behaviour as far as their behaviour takes place within the Union. 3. This Regulation applies to the processing of personal data by a controller not established in the Union, but in a place where Member State law applies by virtue of public international law. Article 4 Definitions For the purposes of this Regulation: (1) \u2018personal data\u2019 means any information relating to an identified or identifiable natural person (\u2018data subject\u2019); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person; (2) \u2018processing\u2019 means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction; (3) \u2018restriction of processing\u2019 means the marking of stored personal data with the aim of limiting their processing in the future; (4) \u2018profiling\u2019 means any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person's performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements; (5) \u2018pseudonymisation\u2019 means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person; (6) \u2018filing system\u2019 means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis; (7) \u2018controller\u2019 means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law; (8) \u2018processor\u2019 means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller; (9) \u2018recipient\u2019 means a natural or legal person, public authority, agency or another body, to which the personal data are disclosed, whether a third party or not. However, public authorities which may receive personal data in the framework of a particular inquiry in accordance with Union or Member State law shall not be regarded as recipients; the processing of those data by those public authorities shall be in compliance with the applicable data protection rules according to the purposes of the processing; (10) \u2018third party\u2019 means a natural or legal person, public authority, agency or body other than the data subject, controller, processor and persons who, under the direct authority of the controller or processor, are authorised to process personal data; (11) \u2018consent\u2019 of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her; (12) \u2018personal data breach\u2019 means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed; (13) \u2018genetic data\u2019 means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question; (14) \u2018biometric data\u2019 means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data; (15) \u2018data concerning health\u2019 means personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status; (16) \u2018main establishment\u2019 means: (a) as regards a controller with establishments in more than one Member State, the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal data are taken in another establishment of the controller in the Union and the latter establishment has the power to have such decisions implemented, in which case the establishment having taken such decisions is to be considered to be the main establishment; (b) as regards a processor with establishments in more than one Member State, the place of its central administration in the Union, or, if the processor has no central administration in the Union, the establishment of the processor in the Union where the main processing activities in the context of the activities of an establishment of the processor take place to the extent that the processor is subject to specific obligations under this Regulation; (17) \u2018representative\u2019 means a natural or legal person established in the Union who, designated by the controller or processor in writing pursuant to Article 27, represents the controller or processor with regard to their respective obligations under this Regulation; (18) \u2018enterprise\u2019 means a natural or legal person engaged in an economic activity, irrespective of its legal form, including partnerships or associations regularly engaged in an economic activity; (19) \u2018group of undertakings\u2019 means a controlling undertaking and its controlled undertakings; (20) \u2018binding corporate rules\u2019 means personal data protection policies which are adhered to by a controller or processor established on the territory of a Member State for transfers or a set of transfers of personal data to a controller or processor in one or more third countries within a group of undertakings, or group of enterprises engaged in a joint economic activity; (21) \u2018supervisory authority\u2019 means an independent public authority which is established by a Member State pursuant to Article 51; (22) \u2018supervisory authority concerned\u2019 means a supervisory authority which is concerned by the processing of personal data because: (a) the controller or processor is established on the territory of the Member State of that supervisory authority; (b) data subjects residing in the Member State of that supervisory authority are substantially affected or likely to be substantially affected by the processing; or (c) a complaint has been lodged with that supervisory authority; (23) \u2018cross-border processing\u2019 means either: (a) processing of personal data which takes place in the context of the activities of establishments in more than one Member State of a controller or processor in the Union where the controller or processor is established in more than one Member State; or (b) processing of personal data which takes place in the context of the activities of a single establishment of a controller or processor in the Union but which substantially affects or is likely to substantially affect data subjects in more than one Member State. (24) \u2018relevant and reasoned objection\u2019 means an objection to a draft decision as to whether there is an infringement of this Regulation, or whether envisaged action in relation to the controller or processor complies with this Regulation, which clearly demonstrates the significance of the risks posed by the draft decision as regards the fundamental rights and freedoms of data subjects and, where applicable, the free flow of personal data within the Union; (25) \u2018information society service\u2019 means a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (19); (26) \u2018international organisation\u2019 means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries. CHAPTER II Principles Article 5 Principles relating to processing of personal data 1. Personal data shall be: (a) processed lawfully, fairly and in a transparent manner in relation to the data subject (\u2018lawfulness, fairness and transparency\u2019); (b) collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes; further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes shall, in accordance with Article 89(1), not be considered to be incompatible with the initial purposes (\u2018purpose limitation\u2019); (c) adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed (\u2018data minimisation\u2019); (d) accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that personal data that are inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay (\u2018accuracy\u2019); (e) kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed; personal data may be stored for longer periods insofar as the personal data will be processed solely for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) subject to implementation of the appropriate technical and organisational measures required by this Regulation in order to safeguard the rights and freedoms of the data subject (\u2018storage limitation\u2019); (f) processed in a manner that ensures appropriate security of the personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures (\u2018integrity and confidentiality\u2019). 2. The controller shall be responsible for, and be able to demonstrate compliance with, paragraph 1 (\u2018accountability\u2019). Article 6 Lawfulness of processing 1. Processing shall be lawful only if and to the extent that at least one of the following applies: (a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes; (b) processing is necessary for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract; (c) processing is necessary for compliance with a legal obligation to which the controller is subject; (d) processing is necessary in order to protect the vital interests of the data subject or of another natural person; (e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; (f) processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. Point (f) of the first subparagraph shall not apply to processing carried out by public authorities in the performance of their tasks. 2. Member States may maintain or introduce more specific provisions to adapt the application of the rules of this Regulation with regard to processing for compliance with points (c) and (e) of paragraph 1 by determining more precisely specific requirements for the processing and other measures to ensure lawful and fair processing including for other specific processing situations as provided for in Chapter IX. 3. The basis for the processing referred to in point (c) and (e) of paragraph 1 shall be laid down by: (a) Union law; or (b) Member State law to which the controller is subject. The purpose of the processing shall be determined in that legal basis or, as regards the processing referred to in point (e) of paragraph 1, shall be necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. That legal basis may contain specific provisions to adapt the application of rules of this Regulation, inter alia: the general conditions governing the lawfulness of processing by the controller; the types of data which are subject to the processing; the data subjects concerned; the entities to, and the purposes for which, the personal data may be disclosed; the purpose limitation; storage periods; and processing operations and processing procedures, including measures to ensure lawful and fair processing such as those for other specific processing situations as provided for in Chapter IX. The Union or the Member State law shall meet an objective of public interest and be proportionate to the legitimate aim pursued. 4. Where the processing for a purpose other than that for which the personal data have been collected is not based on the data subject's consent or on a Union or Member State law which constitutes a necessary and proportionate measure in a democratic society to safeguard the objectives referred to in Article 23(1), the controller shall, in order to ascertain whether processing for another purpose is compatible with the purpose for which the personal data are initially collected, take into account, inter alia: (a) any link between the purposes for which the personal data have been collected and the purposes of the intended further processing; (b) the context in which the personal data have been collected, in particular regarding the relationship between data subjects and the controller; (c) the nature of the personal data, in particular whether special categories of personal data are processed, pursuant to Article 9, or whether personal data related to criminal convictions and offences are processed, pursuant to Article 10; (d) the possible consequences of the intended further processing for data subjects; (e) the existence of appropriate safeguards, which may include encryption or pseudonymisation. Article 7 Conditions for consent 1. Where processing is based on consent, the controller shall be able to demonstrate that the data subject has consented to processing of his or her personal data. 2. If the data subject's consent is given in the context of a written declaration which also concerns other matters, the request for consent shall be presented in a manner which is clearly distinguishable from the other matters, in an intelligible and easily accessible form, using clear and plain language. Any part of such a declaration which constitutes an infringement of this Regulation shall not be binding. 3. The data subject shall have the right to withdraw his or her consent at any time. The withdrawal of consent shall not affect the lawfulness of processing based on consent before its withdrawal. Prior to giving consent, the data subject shall be informed thereof. It shall be as easy to withdraw as to give consent. 4. When assessing whether consent is freely given, utmost account shall be taken of whether, inter alia, the performance of a contract, including the provision of a service, is conditional on consent to the processing of personal data that is not necessary for the performance of that contract. Article 8 Conditions applicable to child's consent in relation to information society services 1. Where point (a) of Article 6(1) applies, in relation to the offer of information society services directly to a child, the processing of the personal data of a child shall be lawful where the child is at least 16 years old. Where the child is below the age of 16 years, such processing shall be lawful only if and to the extent that consent is given or authorised by the holder of parental responsibility over the child. Member States may provide by law for a lower age for those purposes provided that such lower age is not below 13 years. 2. The controller shall make reasonable efforts to verify in such cases that consent is given or authorised by the holder of parental responsibility over the child, taking into consideration available technology. 3. Paragraph 1 shall not affect the general contract law of Member States such as the rules on the validity, formation or effect of a contract in relation to a child. Article 9 Processing of special categories of personal data 1. Processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation shall be prohibited. 2. Paragraph 1 shall not apply if one of the following applies: (a) the data subject has given explicit consent to the processing of those personal data for one or more specified purposes, except where Union or Member State law provide that the prohibition referred to in paragraph 1 may not be lifted by the data subject; (b) processing is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law in so far as it is authorised by Union or Member State law or a collective agreement pursuant to Member State law providing for appropriate safeguards for the fundamental rights and the interests of the data subject; (c) processing is necessary to protect the vital interests of the data subject or of another natural person where the data subject is physically or legally incapable of giving consent; (d) processing is carried out in the course of its legitimate activities with appropriate safeguards by a foundation, association or any other not-for-profit body with a political, philosophical, religious or trade union aim and on condition that the processing relates solely to the members or to former members of the body or to persons who have regular contact with it in connection with its purposes and that the personal data are not disclosed outside that body without the consent of the data subjects; (e) processing relates to personal data which are manifestly made public by the data subject; (f) processing is necessary for the establishment, exercise or defence of legal claims or whenever courts are acting in their judicial capacity; (g) processing is necessary for reasons of substantial public interest, on the basis of Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject; (h) processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3; (i) processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy; (j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. 3. Personal data referred to in paragraph 1 may be processed for the purposes referred to in point (h) of paragraph 2 when those data are processed by or under the responsibility of a professional subject to the obligation of professional secrecy under Union or Member State law or rules established by national competent bodies or by another person also subject to an obligation of secrecy under Union or Member State law or rules established by national competent bodies. 4. Member States may maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health. Article 10 Processing of personal data relating to criminal convictions and offences Processing of personal data relating to criminal convictions and offences or related security measures based on Article 6(1) shall be carried out only under the control of official authority or when the processing is authorised by Union or Member State law providing for appropriate safeguards for the rights and freedoms of data subjects. Any comprehensive register of criminal convictions shall be kept only under the control of official authority. Article 11 Processing which does not require identification 1. If the purposes for which a controller processes personal data do not or do no longer require the identification of a data subject by the controller, the controller shall not be obliged to maintain, acquire or process additional information in order to identify the data subject for the sole purpose of complying with this Regulation. 2. Where, in cases referred to in paragraph 1 of this Article, the controller is able to demonstrate that it is not in a position to identify the data subject, the controller shall inform the data subject accordingly, if possible. In such cases, Articles 15 to 20 shall not apply except where the data subject, for the purpose of exercising his or her rights under those articles, provides additional information enabling his or her identification. CHAPTER III Rights of the data subject Section 1 Transparency and modalities Article 12 Transparent information, communication and modalities for the exercise of the rights of the data subject 1. The controller shall take appropriate measures to provide any information referred to in Articles 13 and 14 and any communication under Articles 15 to 22 and 34 relating to processing to the data subject in a concise, transparent, intelligible and easily accessible form, using clear and plain language, in particular for any information addressed specifically to a child. The information shall be provided in writing, or by other means, including, where appropriate, by electronic means. When requested by the data subject, the information may be provided orally, provided that the identity of the data subject is proven by other means. 2. The controller shall facilitate the exercise of data subject rights under Articles 15 to 22. In the cases referred to in Article 11(2), the controller shall not refuse to act on the request of the data subject for exercising his or her rights under Articles 15 to 22, unless the controller demonstrates that it is not in a position to identify the data subject. 3. The controller shall provide information on action taken on a request under Articles 15 to 22 to the data subject without undue delay and in any event within one month of receipt of the request. That period may be extended by two further months where necessary, taking into account the complexity and number of the requests. The controller shall inform the data subject of any such extension within one month of receipt of the request, together with the reasons for the delay. Where the data subject makes the request by electronic form means, the information shall be provided by electronic means where possible, unless otherwise requested by the data subject. 4. If the controller does not take action on the request of the data subject, the controller shall inform the data subject without delay and at the latest within one month of receipt of the request of the reasons for not taking action and on the possibility of lodging a complaint with a supervisory authority and seeking a judicial remedy. 5. Information provided under Articles 13 and 14 and any communication and any actions taken under Articles 15 to 22 and 34 shall be provided free of charge. Where requests from a data subject are manifestly unfounded or excessive, in particular because of their repetitive character, the controller may either: (a) charge a reasonable fee taking into account the administrative costs of providing the information or communication or taking the action requested; or (b) refuse to act on the request. The controller shall bear the burden of demonstrating the manifestly unfounded or excessive character of the request. 6. Without prejudice to Article 11, where the controller has reasonable doubts concerning the identity of the natural person making the request referred to in Articles 15 to 21, the controller may request the provision of additional information necessary to confirm the identity of the data subject. 7. The information to be provided to data subjects pursuant to Articles 13 and 14 may be provided in combination with standardised icons in order to give in an easily visible, intelligible and clearly legible manner a meaningful overview of the intended processing. Where the icons are presented electronically they shall be machine-readable. 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 92 for the purpose of determining the information to be presented by the icons and the procedures for providing standardised icons. Section 2 Information and access to personal data Article 13 Information to be provided where personal data are collected from the data subject 1. Where personal data relating to a data subject are collected from the data subject, the controller shall, at the time when personal data are obtained, provide the data subject with all of the following information: (a) the identity and the contact details of the controller and, where applicable, of the controller's representative; (b) the contact details of the data protection officer, where applicable; (c) the purposes of the processing for which the personal data are intended as well as the legal basis for the processing; (d) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a third party; (e) the recipients or categories of recipients of the personal data, if any; (f) where applicable, the fact that the controller intends to transfer personal data to a third country or international organisation and the existence or absence of an adequacy decision by the Commission, or in the case of transfers referred to in Article 46 or 47, or the second subparagraph of Article 49(1), reference to the appropriate or suitable safeguards and the means by which to obtain a copy of them or where they have been made available. 2. In addition to the information referred to in paragraph 1, the controller shall, at the time when personal data are obtained, provide the data subject with the following further information necessary to ensure fair and transparent processing: (a) the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period; (b) the existence of the right to request from the controller access to and rectification or erasure of personal data or restriction of processing concerning the data subject or to object to processing as well as the right to data portability; (c) where the processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal; (d) the right to lodge a complaint with a supervisory authority; (e) whether the provision of personal data is a statutory or contractual requirement, or a requirement necessary to enter into a contract, as well as whether the data subject is obliged to provide the personal data and of the possible consequences of failure to provide such data; (f) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject. 3. Where the controller intends to further process the personal data for a purpose other than that for which the personal data were collected, the controller shall provide the data subject prior to that further processing with information on that other purpose and with any relevant further information as referred to in paragraph 2. 4. Paragraphs 1, 2 and 3 shall not apply where and insofar as the data subject already has the information. Article 14 Information to be provided where personal data have not been obtained from the data subject 1. Where personal data have not been obtained from the data subject, the controller shall provide the data subject with the following information: (a) the identity and the contact details of the controller and, where applicable, of the controller's representative; (b) the contact details of the data protection officer, where applicable; (c) the purposes of the processing for which the personal data are intended as well as the legal basis for the processing; (d) the categories of personal data concerned; (e) the recipients or categories of recipients of the personal data, if any; (f) where applicable, that the controller intends to transfer personal data to a recipient in a third country or international organisation and the existence or absence of an adequacy decision by the Commission, or in the case of transfers referred to in Article 46 or 47, or the second subparagraph of Article 49(1), reference to the appropriate or suitable safeguards and the means to obtain a copy of them or where they have been made available. 2. In addition to the information referred to in paragraph 1, the controller shall provide the data subject with the following information necessary to ensure fair and transparent processing in respect of the data subject: (a) the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period; (b) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a third party; (c) the existence of the right to request from the controller access to and rectification or erasure of personal data or restriction of processing concerning the data subject and to object to processing as well as the right to data portability; (d) where processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal; (e) the right to lodge a complaint with a supervisory authority; (f) from which source the personal data originate, and if applicable, whether it came from publicly accessible sources; (g) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject. 3. The controller shall provide the information referred to in paragraphs 1 and 2: (a) within a reasonable period after obtaining the personal data, but at the latest within one month, having regard to the specific circumstances in which the personal data are processed; (b) if the personal data are to be used for communication with the data subject, at the latest at the time of the first communication to that data subject; or (c) if a disclosure to another recipient is envisaged, at the latest when the personal data are first disclosed. 4. Where the controller intends to further process the personal data for a purpose other than that for which the personal data were obtained, the controller shall provide the data subject prior to that further processing with information on that other purpose and with any relevant further information as referred to in paragraph 2. 5. Paragraphs 1 to 4 shall not apply where and insofar as: (a) the data subject already has the information; (b) the provision of such information proves impossible or would involve a disproportionate effort, in particular for processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, subject to the conditions and safeguards referred to in Article 89(1) or in so far as the obligation referred to in paragraph 1 of this Article is likely to render impossible or seriously impair the achievement of the objectives of that processing. In such cases the controller shall take appropriate measures to protect the data subject's rights and freedoms and legitimate interests, including making the information publicly available; (c) obtaining or disclosure is expressly laid down by Union or Member State law to which the controller is subject and which provides appropriate measures to protect the data subject's legitimate interests; or (d) where the personal data must remain confidential subject to an obligation of professional secrecy regulated by Union or Member State law, including a statutory obligation of secrecy. Article 15 Right of access by the data subject 1. The data subject shall have the right to obtain from the controller confirmation as to whether or not personal data concerning him or her are being processed, and, where that is the case, access to the personal data and the following information: (a) the purposes of the processing; (b) the categories of personal data concerned; (c) the recipients or categories of recipient to whom the personal data have been or will be disclosed, in particular recipients in third countries or international organisations; (d) where possible, the envisaged period for which the personal data will be stored, or, if not possible, the criteria used to determine that period; (e) the existence of the right to request from the controller rectification or erasure of personal data or restriction of processing of personal data concerning the data subject or to object to such processing; (f) the right to lodge a complaint with a supervisory authority; (g) where the personal data are not collected from the data subject, any available information as to their source; (h) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject. 2. Where personal data are transferred to a third country or to an international organisation, the data subject shall have the right to be informed of the appropriate safeguards pursuant to Article 46 relating to the transfer. 3. The controller shall provide a copy of the personal data undergoing processing. For any further copies requested by the data subject, the controller may charge a reasonable fee based on administrative costs. Where the data subject makes the request by electronic means, and unless otherwise requested by the data subject, the information shall be provided in a commonly used electronic form. 4. The right to obtain a copy referred to in paragraph 3 shall not adversely affect the rights and freedoms of others. Section 3 Rectification and erasure Article 16 Right to rectification The data subject shall have the right to obtain from the controller without undue delay the rectification of inaccurate personal data concerning him or her. Taking into account the purposes of the processing, the data subject shall have the right to have incomplete personal data completed, including by means of providing a supplementary statement. Article 17 Right to erasure (\u2018right to be forgotten\u2019) 1. The data subject shall have the right to obtain from the controller the erasure of personal data concerning him or her without undue delay and the controller shall have the obligation to erase personal data without undue delay where one of the following grounds applies: (a) the personal data are no longer necessary in relation to the purposes for which they were collected or otherwise processed; (b) the data subject withdraws consent on which the processing is based according to point (a) of Article 6(1), or point (a) of Article 9(2), and where there is no other legal ground for the processing; (c) the data subject objects to the processing pursuant to Article 21(1) and there are no overriding legitimate grounds for the processing, or the data subject objects to the processing pursuant to Article 21(2); (d) the personal data have been unlawfully processed; (e) the personal data have to be erased for compliance with a legal obligation in Union or Member State law to which the controller is subject; (f) the personal data have been collected in relation to the offer of information society services referred to in Article 8(1). 2. Where the controller has made the personal data public and is obliged pursuant to paragraph 1 to erase the personal data, the controller, taking account of available technology and the cost of implementation, shall take reasonable steps, including technical measures, to inform controllers which are processing the personal data that the data subject has requested the erasure by such controllers of any links to, or copy or replication of, those personal data. 3. Paragraphs 1 and 2 shall not apply to the extent that processing is necessary: (a) for exercising the right of freedom of expression and information; (b) for compliance with a legal obligation which requires processing by Union or Member State law to which the controller is subject or for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; (c) for reasons of public interest in the area of public health in accordance with points (h) and (i) of Article 9(2) as well as Article 9(3); (d) for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) in so far as the right referred to in paragraph 1 is likely to render impossible or seriously impair the achievement of the objectives of that processing; or (e) for the establishment, exercise or defence of legal claims. Article 18 Right to restriction of processing 1. The data subject shall have the right to obtain from the controller restriction of processing where one of the following applies: (a) the accuracy of the personal data is contested by the data subject, for a period enabling the controller to verify the accuracy of the personal data; (b) the processing is unlawful and the data subject opposes the erasure of the personal data and requests the restriction of their use instead; (c) the controller no longer needs the personal data for the purposes of the processing, but they are required by the data subject for the establishment, exercise or defence of legal claims; (d) the data subject has objected to processing pursuant to Article 21(1) pending the verification whether the legitimate grounds of the controller override those of the data subject. 2. Where processing has been restricted under paragraph 1, such personal data shall, with the exception of storage, only be processed with the data subject's consent or for the establishment, exercise or defence of legal claims or for the protection of the rights of another natural or legal person or for reasons of important public interest of the Union or of a Member State. 3. A data subject who has obtained restriction of processing pursuant to paragraph 1 shall be informed by the controller before the restriction of processing is lifted. Article 19 Notification obligation regarding rectification or erasure of personal data or restriction of processing The controller shall communicate any rectification or erasure of personal data or restriction of processing carried out in accordance with Article 16, Article 17(1) and Article 18 to each recipient to whom the personal data have been disclosed, unless this proves impossible or involves disproportionate effort. The controller shall inform the data subject about those recipients if the data subject requests it. Article 20 Right to data portability 1. The data subject shall have the right to receive the personal data concerning him or her, which he or she has provided to a controller, in a structured, commonly used and machine-readable format and have the right to transmit those data to another controller without hindrance from the controller to which the personal data have been provided, where: (a) the processing is based on consent pursuant to point (a) of Article 6(1) or point (a) of Article 9(2) or on a contract pursuant to point (b) of Article 6(1); and (b) the processing is carried out by automated means. 2. In exercising his or her right to data portability pursuant to paragraph 1, the data subject shall have the right to have the personal data transmitted directly from one controller to another, where technically feasible. 3. The exercise of the right referred to in paragraph 1 of this Article shall be without prejudice to Article 17. That right shall not apply to processing necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. 4. The right referred to in paragraph 1 shall not adversely affect the rights and freedoms of others. Section 4 Right to object and automated individual decision-making Article 21 Right to object 1. The data subject shall have the right to object, on grounds relating to his or her particular situation, at any time to processing of personal data concerning him or her which is based on point (e) or (f) of Article 6(1), including profiling based on those provisions. The controller shall no longer process the personal data unless the controller demonstrates compelling legitimate grounds for the processing which override the interests, rights and freedoms of the data subject or for the establishment, exercise or defence of legal claims. 2. Where personal data are processed for direct marketing purposes, the data subject shall have the right to object at any time to processing of personal data concerning him or her for such marketing, which includes profiling to the extent that it is related to such direct marketing. 3. Where the data subject objects to processing for direct marketing purposes, the personal data shall no longer be processed for such purposes. 4. At the latest at the time of the first communication with the data subject, the right referred to in paragraphs 1 and 2 shall be explicitly brought to the attention of the data subject and shall be presented clearly and separately from any other information. 5. In the context of the use of information society services, and notwithstanding Directive 2002/58/EC, the data subject may exercise his or her right to object by automated means using technical specifications. 6. Where personal data are processed for scientific or historical research purposes or statistical purposes pursuant to Article 89(1), the data subject, on grounds relating to his or her particular situation, shall have the right to object to processing of personal data concerning him or her, unless the processing is necessary for the performance of a task carried out for reasons of public interest. Article 22 Automated individual decision-making, including profiling 1. The data subject shall have the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her. 2. Paragraph 1 shall not apply if the decision: (a) is necessary for entering into, or performance of, a contract between the data subject and a data controller; (b) is authorised by Union or Member State law to which the controller is subject and which also lays down suitable measures to safeguard the data subject's rights and freedoms and legitimate interests; or (c) is based on the data subject's explicit consent. 3. In the cases referred to in points (a) and (c) of paragraph 2, the data controller shall implement suitable measures to safeguard the data subject's rights and freedoms and legitimate interests, at least the right to obtain human intervention on the part of the controller, to express his or her point of view and to contest the decision. 4. Decisions referred to in paragraph 2 shall not be based on special categories of personal data referred to in Article 9(1), unless point (a) or (g) of Article 9(2) applies and suitable measures to safeguard the data subject's rights and freedoms and legitimate interests are in place. Section 5 Restrictions Article 23 Restrictions 1. Union or Member State law to which the data controller or processor is subject may restrict by way of a legislative measure the scope of the obligations and rights provided for in Articles 12 to 22 and Article 34, as well as Article 5 in so far as its provisions correspond to the rights and obligations provided for in Articles 12 to 22, when such a restriction respects the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in a democratic society to safeguard: (a) national security; (b) defence; (c) public security; (d) the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; (e) other important objectives of general public interest of the Union or of a Member State, in particular an important economic or financial interest of the Union or of a Member State, including monetary, budgetary and taxation a matters, public health and social security; (f) the protection of judicial independence and judicial proceedings; (g) the prevention, investigation, detection and prosecution of breaches of ethics for regulated professions; (h) a monitoring, inspection or regulatory function connected, even occasionally, to the exercise of official authority in the cases referred to in points (a) to (e) and (g); (i) the protection of the data subject or the rights and freedoms of others; (j) the enforcement of civil law claims. 2. In particular, any legislative measure referred to in paragraph 1 shall contain specific provisions at least, where relevant, as to: (a) the purposes of the processing or categories of processing; (b) the categories of personal data; (c) the scope of the restrictions introduced; (d) the safeguards to prevent abuse or unlawful access or transfer; (e) the specification of the controller or categories of controllers; (f) the storage periods and the applicable safeguards taking into account the nature, scope and purposes of the processing or categories of processing; (g) the risks to the rights and freedoms of data subjects; and (h) the right of data subjects to be informed about the restriction, unless that may be prejudicial to the purpose of the restriction. CHAPTER IV Controller and processor Section 1 General obligations Article 24 Responsibility of the controller 1. Taking into account the nature, scope, context and purposes of processing as well as the risks of varying likelihood and severity for the rights and freedoms of natural persons, the controller shall implement appropriate technical and organisational measures to ensure and to be able to demonstrate that processing is performed in accordance with this Regulation. Those measures shall be reviewed and updated where necessary. 2. Where proportionate in relation to processing activities, the measures referred to in paragraph 1 shall include the implementation of appropriate data protection policies by the controller. 3. Adherence to approved codes of conduct as referred to in Article 40 or approved certification mechanisms as referred to in Article 42 may be used as an element by which to demonstrate compliance with the obligations of the controller. Article 25 Data protection by design and by default 1. Taking into account the state of the art, the cost of implementation and the nature, scope, context and purposes of processing as well as the risks of varying likelihood and severity for rights and freedoms of natural persons posed by the processing, the controller shall, both at the time of the determination of the means for processing and at the time of the processing itself, implement appropriate technical and organisational measures, such as pseudonymisation, which are designed to implement data-protection principles, such as data minimisation, in an effective manner and to integrate the necessary safeguards into the processing in order to meet the requirements of this Regulation and protect the rights of data subjects. 2. The controller shall implement appropriate technical and organisational measures for ensuring that, by default, only personal data which are necessary for each specific purpose of the processing are processed. That obligation applies to the amount of personal data collected, the extent of their processing, the period of their storage and their accessibility. In particular, such measures shall ensure that by default personal data are not made accessible without the individual's intervention to an indefinite number of natural persons. 3. An approved certification mechanism pursuant to Article 42 may be used as an element to demonstrate compliance with the requirements set out in paragraphs 1 and 2 of this Article. Article 26 Joint controllers 1. Where two or more controllers jointly determine the purposes and means of processing, they shall be joint controllers. They shall in a transparent manner determine their respective responsibilities for compliance with the obligations under this Regulation, in particular as regards the exercising of the rights of the data subject and their respective duties to provide the information referred to in Articles 13 and 14, by means of an arrangement between them unless, and in so far as, the respective responsibilities of the controllers are determined by Union or Member State law to which the controllers are subject. The arrangement may designate a contact point for data subjects. 2. The arrangement referred to in paragraph 1 shall duly reflect the respective roles and relationships of the joint controllers vis-\u00e0-vis the data subjects. The essence of the arrangement shall be made available to the data subject. 3. Irrespective of the terms of the arrangement referred to in paragraph 1, the data subject may exercise his or her rights under this Regulation in respect of and against each of the controllers. Article 27 Representatives of controllers or processors not established in the Union 1. Where Article 3(2) applies, the controller or the processor shall designate in writing a representative in the Union. 2. The obligation laid down in paragraph 1 of this Article shall not apply to: (a) processing which is occasional, does not include, on a large scale, processing of special categories of data as referred to in Article 9(1) or processing of personal data relating to criminal convictions and offences referred to in Article 10, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature, context, scope and purposes of the processing; or (b) a public authority or body. 3. The representative shall be established in one of the Member States where the data subjects, whose personal data are processed in relation to the offering of goods or services to them, or whose behaviour is monitored, are. 4. The representative shall be mandated by the controller or processor to be addressed in addition to or instead of the controller or the processor by, in particular, supervisory authorities and data subjects, on all issues related to processing, for the purposes of ensuring compliance with this Regulation. 5. The designation of a representative by the controller or processor shall be without prejudice to legal actions which could be initiated against the controller or the processor themselves. Article 28 Processor 1. Where processing is to be carried out on behalf of a controller, the controller shall use only processors providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that processing will meet the requirements of this Regulation and ensure the protection of the rights of the data subject. 2. The processor shall not engage another processor without prior specific or general written authorisation of the controller. In the case of general written authorisation, the processor shall inform the controller of any intended changes concerning the addition or replacement of other processors, thereby giving the controller the opportunity to object to such changes. 3. Processing by a processor shall be governed by a contract or other legal act under Union or Member State law, that is binding on the processor with regard to the controller and that sets out the subject-matter and duration of the processing, the nature and purpose of the processing, the type of personal data and categories of data subjects and the obligations and rights of the controller. That contract or other legal act shall stipulate, in particular, that the processor: (a) processes the personal data only on documented instructions from the controller, including with regard to transfers of personal data to a third country or an international organisation, unless required to do so by Union or Member State law to which the processor is subject; in such a case, the processor shall inform the controller of that legal requirement before processing, unless that law prohibits such information on important grounds of public interest; (b) ensures that persons authorised to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality; (c) takes all measures required pursuant to Article 32; (d) respects the conditions referred to in paragraphs 2 and 4 for engaging another processor; (e) taking into account the nature of the processing, assists the controller by appropriate technical and organisational measures, insofar as this is possible, for the fulfilment of the controller's obligation to respond to requests for exercising the data subject's rights laid down in Chapter III; (f) assists the controller in ensuring compliance with the obligations pursuant to Articles 32 to 36 taking into account the nature of processing and the information available to the processor; (g) at the choice of the controller, deletes or returns all the personal data to the controller after the end of the provision of services relating to processing, and deletes existing copies unless Union or Member State law requires storage of the personal data; (h) makes available to the controller all information necessary to demonstrate compliance with the obligations laid down in this Article and allow for and contribute to audits, including inspections, conducted by the controller or another auditor mandated by the controller. With regard to point (h) of the first subparagraph, the processor shall immediately inform the controller if, in its opinion, an instruction infringes this Regulation or other Union or Member State data protection provisions. 4. Where a processor engages another processor for carrying out specific processing activities on behalf of the controller, the same data protection obligations as set out in the contract or other legal act between the controller and the processor as referred to in paragraph 3 shall be imposed on that other processor by way of a contract or other legal act under Union or Member State law, in particular providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that the processing will meet the requirements of this Regulation. Where that other processor fails to fulfil its data protection obligations, the initial processor shall remain fully liable to the controller for the performance of that other processor's obligations. 5. Adherence of a processor to an approved code of conduct as referred to in Article 40 or an approved certification mechanism as referred to in Article 42 may be used as an element by which to demonstrate sufficient guarantees as referred to in paragraphs 1 and 4 of this Article. 6. Without prejudice to an individual contract between the controller and the processor, the contract or the other legal act referred to in paragraphs 3 and 4 of this Article may be based, in whole or in part, on standard contractual clauses referred to in paragraphs 7 and 8 of this Article, including when they are part of a certification granted to the controller or processor pursuant to Articles 42 and 43. 7. The Commission may lay down standard contractual clauses for the matters referred to in paragraph 3 and 4 of this Article and in accordance with the examination procedure referred to in Article 93(2). 8. A supervisory authority may adopt standard contractual clauses for the matters referred to in paragraph 3 and 4 of this Article and in accordance with the consistency mechanism referred to in Article 63. 9. The contract or the other legal act referred to in paragraphs 3 and 4 shall be in writing, including in electronic form. 10. Without prejudice to Articles 82, 83 and 84, if a processor infringes this Regulation by determining the purposes and means of processing, the processor shall be considered to be a controller in respect of that processing. Article 29 Processing under the authority of the controller or processor The processor and any person acting under the authority of the controller or of the processor, who has access to personal data, shall not process those data except on instructions from the controller, unless required to do so by Union or Member State law. Article 30 Records of processing activities 1. Each controller and, where applicable, the controller's representative, shall maintain a record of processing activities under its responsibility. That record shall contain all of the following information: (a) the name and contact details of the controller and, where applicable, the joint controller, the controller's representative and the data protection officer; (b) the purposes of the processing; (c) a description of the categories of data subjects and of the categories of personal data; (d) the categories of recipients to whom the personal data have been or will be disclosed including recipients in third countries or international organisations; (e) where applicable, transfers of personal data to a third country or an international organisation, including the identification of that third country or international organisation and, in the case of transfers referred to in the second subparagraph of Article 49(1), the documentation of suitable safeguards; (f) where possible, the envisaged time limits for erasure of the different categories of data; (g) where possible, a general description of the technical and organisational security measures referred to in Article 32(1). 2. Each processor and, where applicable, the processor's representative shall maintain a record of all categories of processing activities carried out on behalf of a controller, containing: (a) the name and contact details of the processor or processors and of each controller on behalf of which the processor is acting, and, where applicable, of the controller's or the processor's representative, and the data protection officer; (b) the categories of processing carried out on behalf of each controller; (c) where applicable, transfers of personal data to a third country or an international organisation, including the identification of that third country or international organisation and, in the case of transfers referred to in the second subparagraph of Article 49(1), the documentation of suitable safeguards; (d) where possible, a general description of the technical and organisational security measures referred to in Article 32(1). 3. The records referred to in paragraphs 1 and 2 shall be in writing, including in electronic form. 4. The controller or the processor and, where applicable, the controller's or the processor's representative, shall make the record available to the supervisory authority on request. 5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 250 persons unless the processing it carries out is likely to result in a risk to the rights and freedoms of data subjects, the processing is not occasional, or the processing includes special categories of data as referred to in Article 9(1) or personal data relating to criminal convictions and offences referred to in Article 10. Article 31 Cooperation with the supervisory authority The controller and the processor and, where applicable, their representatives, shall cooperate, on request, with the supervisory authority in the performance of its tasks. Section 2 Security of personal data Article 32 Security of processing 1. Taking into account the state of the art, the costs of implementation and the nature, scope, context and purposes of processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons, the controller and the processor shall implement appropriate technical and organisational measures to ensure a level of security appropriate to the risk, including inter alia as appropriate: (a) the pseudonymisation and encryption of personal data; (b) the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services; (c) the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident; (d) a process for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures for ensuring the security of the processing. 2. In assessing the appropriate level of security account shall be taken in particular of the risks that are presented by processing, in particular from accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to personal data transmitted, stored or otherwise processed. 3. Adherence to an approved code of conduct as referred to in Article 40 or an approved certification mechanism as referred to in Article 42 may be used as an element by which to demonstrate compliance with the requirements set out in paragraph 1 of this Article. 4. The controller and processor shall take steps to ensure that any natural person acting under the authority of the controller or the processor who has access to personal data does not process them except on instructions from the controller, unless he or she is required to do so by Union or Member State law. Article 33 Notification of a personal data breach to the supervisory authority 1. In the case of a personal data breach, the controller shall without undue delay and, where feasible, not later than 72 hours after having become aware of it, notify the personal data breach to the supervisory authority competent in accordance with Article 55, unless the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons. Where the notification to the supervisory authority is not made within 72 hours, it shall be accompanied by reasons for the delay. 2. The processor shall notify the controller without undue delay after becoming aware of a personal data breach. 3. The notification referred to in paragraph 1 shall at least: (a) describe the nature of the personal data breach including where possible, the categories and approximate number of data subjects concerned and the categories and approximate number of personal data records concerned; (b) communicate the name and contact details of the data protection officer or other contact point where more information can be obtained; (c) describe the likely consequences of the personal data breach; (d) describe the measures taken or proposed to be taken by the controller to address the personal data breach, including, where appropriate, measures to mitigate its possible adverse effects. 4. Where, and in so far as, it is not possible to provide the information at the same time, the information may be provided in phases without undue further delay. 5. The controller shall document any personal data breaches, comprising the facts relating to the personal data breach, its effects and the remedial action taken. That documentation shall enable the supervisory authority to verify compliance with this Article. Article 34 Communication of a personal data breach to the data subject 1. When the personal data breach is likely to result in a high risk to the rights and freedoms of natural persons, the controller shall communicate the personal data breach to the data subject without undue delay. 2. The communication to the data subject referred to in paragraph 1 of this Article shall describe in clear and plain language the nature of the personal data breach and contain at least the information and measures referred to in points (b), (c) and (d) of Article 33(3). 3. The communication to the data subject referred to in paragraph 1 shall not be required if any of the following conditions are met: (a) the controller has implemented appropriate technical and organisational protection measures, and those measures were applied to the personal data affected by the personal data breach, in particular those that render the personal data unintelligible to any person who is not authorised to access it, such as encryption; (b) the controller has taken subsequent measures which ensure that the high risk to the rights and freedoms of data subjects referred to in paragraph 1 is no longer likely to materialise; (c) it would involve disproportionate effort. In such a case, there shall instead be a public communication or similar measure whereby the data subjects are informed in an equally effective manner. 4. If the controller has not already communicated the personal data breach to the data subject, the supervisory authority, having considered the likelihood of the personal data breach resulting in a high risk, may require it to do so or may decide that any of the conditions referred to in paragraph 3 are met. Section 3 Data protection impact assessment and prior consultation Article 35 Data protection impact assessment 1. Where a type of processing in particular using new technologies, and taking into account the nature, scope, context and purposes of the processing, is likely to result in a high risk to the rights and freedoms of natural persons, the controller shall, prior to the processing, carry out an assessment of the impact of the envisaged processing operations on the protection of personal data. A single assessment may address a set of similar processing operations that present similar high risks. 2. The controller shall seek the advice of the data protection officer, where designated, when carrying out a data protection impact assessment. 3. A data protection impact assessment referred to in paragraph 1 shall in particular be required in the case of: (a) a systematic and extensive evaluation of personal aspects relating to natural persons which is based on automated processing, including profiling, and on which decisions are based that produce legal effects concerning the natural person or similarly significantly affect the natural person; (b) processing on a large scale of special categories of data referred to in Article 9(1), or of personal data relating to criminal convictions and offences referred to in Article 10; or (c) a systematic monitoring of a publicly accessible area on a large scale. 4. The supervisory authority shall establish and make public a list of the kind of processing operations which are subject to the requirement for a data protection impact assessment pursuant to paragraph 1. The supervisory authority shall communicate those lists to the Board referred to in Article 68. 5. The supervisory authority may also establish and make public a list of the kind of processing operations for which no data protection impact assessment is required. The supervisory authority shall communicate those lists to the Board. 6. Prior to the adoption of the lists referred to in paragraphs 4 and 5, the competent supervisory authority shall apply the consistency mechanism referred to in Article 63 where such lists involve processing activities which are related to the offering of goods or services to data subjects or to the monitoring of their behaviour in several Member States, or may substantially affect the free movement of personal data within the Union. 7. The assessment shall contain at least: (a) a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the controller; (b) an assessment of the necessity and proportionality of the processing operations in relation to the purposes; (c) an assessment of the risks to the rights and freedoms of data subjects referred to in paragraph 1; and (d) the measures envisaged to address the risks, including safeguards, security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with this Regulation taking into account the rights and legitimate interests of data subjects and other persons concerned. 8. Compliance with approved codes of conduct referred to in Article 40 by the relevant controllers or processors shall be taken into due account in assessing the impact of the processing operations performed by such controllers or processors, in particular for the purposes of a data protection impact assessment. 9. Where appropriate, the controller shall seek the views of data subjects or their representatives on the intended processing, without prejudice to the protection of commercial or public interests or the security of processing operations. 10. Where processing pursuant to point (c) or (e) of Article 6(1) has a legal basis in Union law or in the law of the Member State to which the controller is subject, that law regulates the specific processing operation or set of operations in question, and a data protection impact assessment has already been carried out as part of a general impact assessment in the context of the adoption of that legal basis, paragraphs 1 to 7 shall not apply unless Member States deem it to be necessary to carry out such an assessment prior to processing activities. 11. Where necessary, the controller shall carry out a review to assess if processing is performed in accordance with the data protection impact assessment at least when there is a change of the risk represented by processing operations. Article 36 Prior consultation 1. The controller shall consult the supervisory authority prior to processing where a data protection impact assessment under Article 35 indicates that the processing would result in a high risk in the absence of measures taken by the controller to mitigate the risk. 2. Where the supervisory authority is of the opinion that the intended processing referred to in paragraph 1 would infringe this Regulation, in particular where the controller has insufficiently identified or mitigated the risk, the supervisory authority shall, within period of up to eight weeks of receipt of the request for consultation, provide written advice to the controller and, where applicable to the processor, and may use any of its powers referred to in Article 58. That period may be extended by six weeks, taking into account the complexity of the intended processing. The supervisory authority shall inform the controller and, where applicable, the processor, of any such extension within one month of receipt of the request for consultation together with the reasons for the delay. Those periods may be suspended until the supervisory authority has obtained information it has requested for the purposes of the consultation. 3. When consulting the supervisory authority pursuant to paragraph 1, the controller shall provide the supervisory authority with: (a) where applicable, the respective responsibilities of the controller, joint controllers and processors involved in the processing, in particular for processing within a group of undertakings; (b) the purposes and means of the intended processing; (c) the measures and safeguards provided to protect the rights and freedoms of data subjects pursuant to this Regulation; (d) where applicable, the contact details of the data protection officer; (e) the data protection impact assessment provided for in Article 35; and (f) any other information requested by the supervisory authority. 4. Member States shall consult the supervisory authority during the preparation of a proposal for a legislative measure to be adopted by a national parliament, or of a regulatory measure based on such a legislative measure, which relates to processing. 5. Notwithstanding paragraph 1, Member State law may require controllers to consult with, and obtain prior authorisation from, the supervisory authority in relation to processing by a controller for the performance of a task carried out by the controller in the public interest, including processing in relation to social protection and public health. Section 4 Data protection officer Article 37 Designation of the data protection officer 1. The controller and the processor shall designate a data protection officer in any case where: (a) the processing is carried out by a public authority or body, except for courts acting in their judicial capacity; (b) the core activities of the controller or the processor consist of processing operations which, by virtue of their nature, their scope and/or their purposes, require regular and systematic monitoring of data subjects on a large scale; or (c) the core activities of the controller or the processor consist of processing on a large scale of special categories of data pursuant to Article 9 and personal data relating to criminal convictions and offences referred to in Article 10. 2. A group of undertakings may appoint a single data protection officer provided that a data protection officer is easily accessible from each establishment. 3. Where the controller or the processor is a public authority or body, a single data protection officer may be designated for several such authorities or bodies, taking account of their organisational structure and size. 4. In cases other than those referred to in paragraph 1, the controller or processor or associations and other bodies representing categories of controllers or processors may or, where required by Union or Member State law shall, designate a data protection officer. The data protection officer may act for such associations and other bodies representing controllers or processors. 5. The data protection officer shall be designated on the basis of professional qualities and, in particular, expert knowledge of data protection law and practices and the ability to fulfil the tasks referred to in Article 39. 6. The data protection officer may be a staff member of the controller or processor, or fulfil the tasks on the basis of a service contract. 7. The controller or the processor shall publish the contact details of the data protection officer and communicate them to the supervisory authority. Article 38 Position of the data protection officer 1. The controller and the processor shall ensure that the data protection officer is involved, properly and in a timely manner, in all issues which relate to the protection of personal data. 2. The controller and processor shall support the data protection officer in performing the tasks referred to in Article 39 by providing resources necessary to carry out those tasks and access to personal data and processing operations, and to maintain his or her expert knowledge. 3. The controller and processor shall ensure that the data protection officer does not receive any instructions regarding the exercise of those tasks. He or she shall not be dismissed or penalised by the controller or the processor for performing his tasks. The data protection officer shall directly report to the highest management level of the controller or the processor. 4. Data subjects may contact the data protection officer with regard to all issues related to processing of their personal data and to the exercise of their rights under this Regulation. 5. The data protection officer shall be bound by secrecy or confidentiality concerning the performance of his or her tasks, in accordance with Union or Member State law. 6. The data protection officer may fulfil other tasks and duties. The controller or processor shall ensure that any such tasks and duties do not result in a conflict of interests. Article 39 Tasks of the data protection officer 1. The data protection officer shall have at least the following tasks: (a) to inform and advise the controller or the processor and the employees who carry out processing of their obligations pursuant to this Regulation and to other Union or Member State data protection provisions; (b) to monitor compliance with this Regulation, with other Union or Member State data protection provisions and with the policies of the controller or processor in relation to the protection of personal data, including the assignment of responsibilities, awareness-raising and training of staff involved in processing operations, and the related audits; (c) to provide advice where requested as regards the data protection impact assessment and monitor its performance pursuant to Article 35; (d) to cooperate with the supervisory authority; (e) to act as the contact point for the supervisory authority on issues relating to processing, including the prior consultation referred to in Article 36, and to consult, where appropriate, with regard to any other matter. 2. The data protection officer shall in the performance of his or her tasks have due regard to the risk associated with processing operations, taking into account the nature, scope, context and purposes of processing. Section 5 Codes of conduct and certification Article 40 Codes of conduct 1. The Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper application of this Regulation, taking account of the specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises. 2. Associations and other bodies representing categories of controllers or processors may prepare codes of conduct, or amend or extend such codes, for the purpose of specifying the application of this Regulation, such as with regard to: (a) fair and transparent processing; (b) the legitimate interests pursued by controllers in specific contexts; (c) the collection of personal data; (d) the pseudonymisation of personal data; (e) the information provided to the public and to data subjects; (f) the exercise of the rights of data subjects; (g) the information provided to, and the protection of, children, and the manner in which the consent of the holders of parental responsibility over children is to be obtained; (h) the measures and procedures referred to in Articles 24 and 25 and the measures to ensure security of processing referred to in Article 32; (i) the notification of personal data breaches to supervisory authorities and the communication of such personal data breaches to data subjects; (j) the transfer of personal data to third countries or international organisations; or (k) out-of-court proceedings and other dispute resolution procedures for resolving disputes between controllers and data subjects with regard to processing, without prejudice to the rights of data subjects pursuant to Articles 77 and 79. 3. In addition to adherence by controllers or processors subject to this Regulation, codes of conduct approved pursuant to paragraph 5 of this Article and having general validity pursuant to paragraph 9 of this Article may also be adhered to by controllers or processors that are not subject to this Regulation pursuant to Article 3 in order to provide appropriate safeguards within the framework of personal data transfers to third countries or international organisations under the terms referred to in point (e) of Article 46(2). Such controllers or processors shall make binding and enforceable commitments, via contractual or other legally binding instruments, to apply those appropriate safeguards including with regard to the rights of data subjects. 4. A code of conduct referred to in paragraph 2 of this Article shall contain mechanisms which enable the body referred to in Article 41(1) to carry out the mandatory monitoring of compliance with its provisions by the controllers or processors which undertake to apply it, without prejudice to the tasks and powers of supervisory authorities competent pursuant to Article 55 or 56. 5. Associations and other bodies referred to in paragraph 2 of this Article which intend to prepare a code of conduct or to amend or extend an existing code shall submit the draft code, amendment or extension to the supervisory authority which is competent pursuant to Article 55. The supervisory authority shall provide an opinion on whether the draft code, amendment or extension complies with this Regulation and shall approve that draft code, amendment or extension if it finds that it provides sufficient appropriate safeguards. 6. Where the draft code, or amendment or extension is approved in accordance with paragraph 5, and where the code of conduct concerned does not relate to processing activities in several Member States, the supervisory authority shall register and publish the code. 7. Where a draft code of conduct relates to processing activities in several Member States, the supervisory authority which is competent pursuant to Article 55 shall, before approving the draft code, amendment or extension, submit it in the procedure referred to in Article 63 to the Board which shall provide an opinion on whether the draft code, amendment or extension complies with this Regulation or, in the situation referred to in paragraph 3 of this Article, provides appropriate safeguards. 8. Where the opinion referred to in paragraph 7 confirms that the draft code, amendment or extension complies with this Regulation, or, in the situation referred to in paragraph 3, provides appropriate safeguards, the Board shall submit its opinion to the Commission. 9. The Commission may, by way of implementing acts, decide that the approved code of conduct, amendment or extension submitted to it pursuant to paragraph 8 of this Article have general validity within the Union. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 93(2). 10. The Commission shall ensure appropriate publicity for the approved codes which have been decided as having general validity in accordance with paragraph 9. 11. The Board shall collate all approved codes of conduct, amendments and extensions in a register and shall make them publicly available by way of appropriate means. Article 41 Monitoring of approved codes of conduct 1. Without prejudice to the tasks and powers of the competent supervisory authority under Articles 57 and 58, the monitoring of compliance with a code of conduct pursuant to Article 40 may be carried out by a body which has an appropriate level of expertise in relation to the subject-matter of the code and is accredited for that purpose by the competent supervisory authority. 2. A body as referred to in paragraph 1 may be accredited to monitor compliance with a code of conduct where that body has: (a) demonstrated its independence and expertise in relation to the subject-matter of the code to the satisfaction of the competent supervisory authority; (b) established procedures which allow it to assess the eligibility of controllers and processors concerned to apply the code, to monitor their compliance with its provisions and to periodically review its operation; (c) established procedures and structures to handle complaints about infringements of the code or the manner in which the code has been, or is being, implemented by a controller or processor, and to make those procedures and structures transparent to data subjects and the public; and (d) demonstrated to the satisfaction of the competent supervisory authority that its tasks and duties do not result in a conflict of interests. 3. The competent supervisory authority shall submit the draft criteria for accreditation of a body as referred to in paragraph 1 of this Article to the Board pursuant to the consistency mechanism referred to in Article 63. 4. Without prejudice to the tasks and powers of the competent supervisory authority and the provisions of Chapter VIII, a body as referred to in paragraph 1 of this Article shall, subject to appropriate safeguards, take appropriate action in cases of infringement of the code by a controller or processor, including suspension or exclusion of the controller or processor concerned from the code. It shall inform the competent supervisory authority of such actions and the reasons for taking them. 5. The competent supervisory authority shall revoke the accreditation of a body as referred to in paragraph 1 if the conditions for accreditation are not, or are no longer, met or where actions taken by the body infringe this Regulation. 6. This Article shall not apply to processing carried out by public authorities and bodies. Article 42 Certification 1. The Member States, the supervisory authorities, the Board and the Commission shall encourage, in particular at Union level, the establishment of data protection certification mechanisms and of data protection seals and marks, for the purpose of demonstrating compliance with this Regulation of processing operations by controllers and processors. The specific needs of micro, small and medium-sized enterprises shall be taken into account. 2. In addition to adherence by controllers or processors subject to this Regulation, data protection certification mechanisms, seals or marks approved pursuant to paragraph 5 of this Article may be established for the purpose of demonstrating the existence of appropriate safeguards provided by controllers or processors that are not subject to this Regulation pursuant to Article 3 within the framework of personal data transfers to third countries or international organisations under the terms referred to in point (f) of Article 46(2). Such controllers or processors shall make binding and enforceable commitments, via contractual or other legally binding instruments, to apply those appropriate safeguards, including with regard to the rights of data subjects. 3. The certification shall be voluntary and available via a process that is transparent. 4. A certification pursuant to this Article does not reduce the responsibility of the controller or the processor for compliance with this Regulation and is without prejudice to the tasks and powers of the supervisory authorities which are competent pursuant to Article 55 or 56. 5. A certification pursuant to this Article shall be issued by the certification bodies referred to in Article 43 or by the competent supervisory authority, on the basis of criteria approved by that competent supervisory authority pursuant to Article 58(3) or by the Board pursuant to Article 63. Where the criteria are approved by the Board, this may result in a common certification, the European Data Protection Seal. 6. The controller or processor which submits its processing to the certification mechanism shall provide the certification body referred to in Article 43, or where applicable, the competent supervisory authority, with all information and access to its processing activities which are necessary to conduct the certification procedure. 7. Certification shall be issued to a controller or processor for a maximum period of three years and may be renewed, under the same conditions, provided that the relevant requirements continue to be met. Certification shall be withdrawn, as applicable, by the certification bodies referred to in Article 43 or by the competent supervisory authority where the requirements for the certification are not or are no longer met. 8. The Board shall collate all certification mechanisms and data protection seals and marks in a register and shall make them publicly available by any appropriate means. Article 43 Certification bodies 1. Without prejudice to the tasks and powers of the competent supervisory authority under Articles 57 and 58, certification bodies which have an appropriate level of expertise in relation to data protection shall, after informing the supervisory authority in order to allow it to exercise its powers pursuant to point (h) of Article 58(2) where necessary, issue and renew certification. Member States shall ensure that those certification bodies are accredited by one or both of the following: (a) the supervisory authority which is competent pursuant to Article 55 or 56; (b) the national accreditation body named in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council (20) in accordance with EN-ISO/IEC 17065/2012 and with the additional requirements established by the supervisory authority which is competent pursuant to Article 55 or 56. 2. Certification bodies referred to in paragraph 1 shall be accredited in accordance with that paragraph only where they have: (a) demonstrated their independence and expertise in relation to the subject-matter of the certification to the satisfaction of the competent supervisory authority; (b) undertaken to respect the criteria referred to in Article 42(5) and approved by the supervisory authority which is competent pursuant to Article 55 or 56 or by the Board pursuant to Article 63; (c) established procedures for the issuing, periodic review and withdrawal of data protection certification, seals and marks; (d) established procedures and structures to handle complaints about infringements of the certification or the manner in which the certification has been, or is being, implemented by the controller or processor, and to make those procedures and structures transparent to data subjects and the public; and (e) demonstrated, to the satisfaction of the competent supervisory authority, that their tasks and duties do not result in a conflict of interests. 3. The accreditation of certification bodies as referred to in paragraphs 1 and 2 of this Article shall take place on the basis of criteria approved by the supervisory authority which is competent pursuant to Article 55 or 56 or by the Board pursuant to Article 63. In the case of accreditation pursuant to point (b) of paragraph 1 of this Article, those requirements shall complement those envisaged in Regulation (EC) No 765/2008 and the technical rules that describe the methods and procedures of the certification bodies. 4. The certification bodies referred to in paragraph 1 shall be responsible for the proper assessment leading to the certification or the withdrawal of such certification without prejudice to the responsibility of the controller or processor for compliance with this Regulation. The accreditation shall be issued for a maximum period of five years and may be renewed on the same conditions provided that the certification body meets the requirements set out in this Article. 5. The certification bodies referred to in paragraph 1 shall provide the competent supervisory authorities with the reasons for granting or withdrawing the requested certification. 6. The requirements referred to in paragraph 3 of this Article and the criteria referred to in Article 42(5) shall be made public by the supervisory authority in an easily accessible form. The supervisory authorities shall also transmit those requirements and criteria to the Board. The Board shall collate all certification mechanisms and data protection seals in a register and shall make them publicly available by any appropriate means. 7. Without prejudice to Chapter VIII, the competent supervisory authority or the national accreditation body shall revoke an accreditation of a certification body pursuant to paragraph 1 of this Article where the conditions for the accreditation are not, or are no longer, met or where actions taken by a certification body infringe this Regulation. 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 92 for the purpose of specifying the requirements to be taken into account for the data protection certification mechanisms referred to in Article 42(1). 9. The Commission may adopt implementing acts laying down technical standards for certification mechanisms and data protection seals and marks, and mechanisms to promote and recognise those certification mechanisms, seals and marks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2). CHAPTER V Transfers of personal data to third countries or international organisations Article 44 General principle for transfers Any transfer of personal data which are undergoing processing or are intended for processing after transfer to a third country or to an international organisation shall take place only if, subject to the other provisions of this Regulation, the conditions laid down in this Chapter are complied with by the controller and processor, including for onward transfers of personal data from the third country or an international organisation to another third country or to another international organisation. All provisions in this Chapter shall be applied in order to ensure that the level of protection of natural persons guaranteed by this Regulation is not undermined. Article 45 Transfers on the basis of an adequacy decision 1. A transfer of personal data to a third country or an international organisation may take place where the Commission has decided that the third country, a territory or one or more specified sectors within that third country, or the international organisation in question ensures an adequate level of protection. Such a transfer shall not require any specific authorisation. 2. When assessing the adequacy of the level of protection, the Commission shall, in particular, take account of the following elements: (a) the rule of law, respect for human rights and fundamental freedoms, relevant legislation, both general and sectoral, including concerning public security, defence, national security and criminal law and the access of public authorities to personal data, as well as the implementation of such legislation, data protection rules, professional rules and security measures, including rules for the onward transfer of personal data to another third country or international organisation which are complied with in that country or international organisation, case-law, as well as effective and enforceable data subject rights and effective administrative and judicial redress for the data subjects whose personal data are being transferred; (b) the existence and effective functioning of one or more independent supervisory authorities in the third country or to which an international organisation is subject, with responsibility for ensuring and enforcing compliance with the data protection rules, including adequate enforcement powers, for assisting and advising the data subjects in exercising their rights and for cooperation with the supervisory authorities of the Member States; and (c) the international commitments the third country or international organisation concerned has entered into, or other obligations arising from legally binding conventions or instruments as well as from its participation in multilateral or regional systems, in particular in relation to the protection of personal data. 3. The Commission, after assessing the adequacy of the level of protection, may decide, by means of implementing act, that a third country, a territory or one or more specified sectors within a third country, or an international organisation ensures an adequate level of protection within the meaning of paragraph 2 of this Article. The implementing act shall provide for a mechanism for a periodic review, at least every four years, which shall take into account all relevant developments in the third country or international organisation. The implementing act shall specify its territorial and sectoral application and, where applicable, identify the supervisory authority or authorities referred to in point (b) of paragraph 2 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 93(2). 4. The Commission shall, on an ongoing basis, monitor developments in third countries and international organisations that could affect the functioning of decisions adopted pursuant to paragraph 3 of this Article and decisions adopted on the basis of Article 25(6) of Directive 95/46/EC. 5. The Commission shall, where available information reveals, in particular following the review referred to in paragraph 3 of this Article, that a third country, a territory or one or more specified sectors within a third country, or an international organisation no longer ensures an adequate level of protection within the meaning of paragraph 2 of this Article, to the extent necessary, repeal, amend or suspend the decision referred to in paragraph 3 of this Article by means of implementing acts without retro-active effect. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2). On duly justified imperative grounds of urgency, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 93(3). 6. The Commission shall enter into consultations with the third country or international organisation with a view to remedying the situation giving rise to the decision made pursuant to paragraph 5. 7. A decision pursuant to paragraph 5 of this Article is without prejudice to transfers of personal data to the third country, a territory or one or more specified sectors within that third country, or the international organisation in question pursuant to Articles 46 to 49. 8. The Commission shall publish in the Official Journal of the European Union and on its website a list of the third countries, territories and specified sectors within a third country and international organisations for which it has decided that an adequate level of protection is or is no longer ensured. 9. Decisions adopted by the Commission on the basis of Article 25(6) of Directive 95/46/EC shall remain in force until amended, replaced or repealed by a Commission Decision adopted in accordance with paragraph 3 or 5 of this Article. Article 46 Transfers subject to appropriate safeguards 1. In the absence of a decision pursuant to Article 45(3), a controller or processor may transfer personal data to a third country or an international organisation only if the controller or processor has provided appropriate safeguards, and on condition that enforceable data subject rights and effective legal remedies for data subjects are available. 2. The appropriate safeguards referred to in paragraph 1 may be provided for, without requiring any specific authorisation from a supervisory authority, by: (a) a legally binding and enforceable instrument between public authorities or bodies; (b) binding corporate rules in accordance with Article 47; (c) standard data protection clauses adopted by the Commission in accordance with the examination procedure referred to in Article 93(2); (d) standard data protection clauses adopted by a supervisory authority and approved by the Commission pursuant to the examination procedure referred to in Article 93(2); (e) an approved code of conduct pursuant to Article 40 together with binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards, including as regards data subjects' rights; or (f) an approved certification mechanism pursuant to Article 42 together with binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards, including as regards data subjects' rights. 3. Subject to the authorisation from the competent supervisory authority, the appropriate safeguards referred to in paragraph 1 may also be provided for, in particular, by: (a) contractual clauses between the controller or processor and the controller, processor or the recipient of the personal data in the third country or international organisation; or (b) provisions to be inserted into administrative arrangements between public authorities or bodies which include enforceable and effective data subject rights. 4. The supervisory authority shall apply the consistency mechanism referred to in Article 63 in the cases referred to in paragraph 3 of this Article. 5. Authorisations by a Member State or supervisory authority on the basis of Article 26(2) of Directive 95/46/EC shall remain valid until amended, replaced or repealed, if necessary, by that supervisory authority. Decisions adopted by the Commission on the basis of Article 26(4) of Directive 95/46/EC shall remain in force until amended, replaced or repealed, if necessary, by a Commission Decision adopted in accordance with paragraph 2 of this Article. Article 47 Binding corporate rules 1. The competent supervisory authority shall approve binding corporate rules in accordance with the consistency mechanism set out in Article 63, provided that they: (a) are legally binding and apply to and are enforced by every member concerned of the group of undertakings, or group of enterprises engaged in a joint economic activity, including their employees; (b) expressly confer enforceable rights on data subjects with regard to the processing of their personal data; and (c) fulfil the requirements laid down in paragraph 2. 2. The binding corporate rules referred to in paragraph 1 shall specify at least: (a) the structure and contact details of the group of undertakings, or group of enterprises engaged in a joint economic activity and of each of its members; (b) the data transfers or set of transfers, including the categories of personal data, the type of processing and its purposes, the type of data subjects affected and the identification of the third country or countries in question; (c) their legally binding nature, both internally and externally; (d) the application of the general data protection principles, in particular purpose limitation, data minimisation, limited storage periods, data quality, data protection by design and by default, legal basis for processing, processing of special categories of personal data, measures to ensure data security, and the requirements in respect of onward transfers to bodies not bound by the binding corporate rules; (e) the rights of data subjects in regard to processing and the means to exercise those rights, including the right not to be subject to decisions based solely on automated processing, including profiling in accordance with Article 22, the right to lodge a complaint with the competent supervisory authority and before the competent courts of the Member States in accordance with Article 79, and to obtain redress and, where appropriate, compensation for a breach of the binding corporate rules; (f) the acceptance by the controller or processor established on the territory of a Member State of liability for any breaches of the binding corporate rules by any member concerned not established in the Union; the controller or the processor shall be exempt from that liability, in whole or in part, only if it proves that that member is not responsible for the event giving rise to the damage; (g) how the information on the binding corporate rules, in particular on the provisions referred to in points (d), (e) and (f) of this paragraph is provided to the data subjects in addition to Articles 13 and 14; (h) the tasks of any data protection officer designated in accordance with Article 37 or any other person or entity in charge of the monitoring compliance with the binding corporate rules within the group of undertakings, or group of enterprises engaged in a joint economic activity, as well as monitoring training and complaint-handling; (i) the complaint procedures; (j) the mechanisms within the group of undertakings, or group of enterprises engaged in a joint economic activity for ensuring the verification of compliance with the binding corporate rules. Such mechanisms shall include data protection audits and methods for ensuring corrective actions to protect the rights of the data subject. Results of such verification should be communicated to the person or entity referred to in point (h) and to the board of the controlling undertaking of a group of undertakings, or of the group of enterprises engaged in a joint economic activity, and should be available upon request to the competent supervisory authority; (k) the mechanisms for reporting and recording changes to the rules and reporting those changes to the supervisory authority; (l) the cooperation mechanism with the supervisory authority to ensure compliance by any member of the group of undertakings, or group of enterprises engaged in a joint economic activity, in particular by making available to the supervisory authority the results of verifications of the measures referred to in point (j); (m) the mechanisms for reporting to the competent supervisory authority any legal requirements to which a member of the group of undertakings, or group of enterprises engaged in a joint economic activity is subject in a third country which are likely to have a substantial adverse effect on the guarantees provided by the binding corporate rules; and (n) the appropriate data protection training to personnel having permanent or regular access to personal data. 3. The Commission may specify the format and procedures for the exchange of information between controllers, processors and supervisory authorities for binding corporate rules within the meaning of this Article. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 93(2). Article 48 Transfers or disclosures not authorised by Union law Any judgment of a court or tribunal and any decision of an administrative authority of a third country requiring a controller or processor to transfer or disclose personal data may only be recognised or enforceable in any manner if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State, without prejudice to other grounds for transfer pursuant to this Chapter. Article 49 Derogations for specific situations 1. In the absence of an adequacy decision pursuant to Article 45(3), or of appropriate safeguards pursuant to Article 46, including binding corporate rules, a transfer or a set of transfers of personal data to a third country or an international organisation shall take place only on one of the following conditions: (a) the data subject has explicitly consented to the proposed transfer, after having been informed of the possible risks of such transfers for the data subject due to the absence of an adequacy decision and appropriate safeguards; (b) the transfer is necessary for the performance of a contract between the data subject and the controller or the implementation of pre-contractual measures taken at the data subject's request; (c) the transfer is necessary for the conclusion or performance of a contract concluded in the interest of the data subject between the controller and another natural or legal person; (d) the transfer is necessary for important reasons of public interest; (e) the transfer is necessary for the establishment, exercise or defence of legal claims; (f) the transfer is necessary in order to protect the vital interests of the data subject or of other persons, where the data subject is physically or legally incapable of giving consent; (g) the transfer is made from a register which according to Union or Member State law is intended to provide information to the public and which is open to consultation either by the public in general or by any person who can demonstrate a legitimate interest, but only to the extent that the conditions laid down by Union or Member State law for consultation are fulfilled in the particular case. Where a transfer could not be based on a provision in Article 45 or 46, including the provisions on binding corporate rules, and none of the derogations for a specific situation referred to in the first subparagraph of this paragraph is applicable, a transfer to a third country or an international organisation may take place only if the transfer is not repetitive, concerns only a limited number of data subjects, is necessary for the purposes of compelling legitimate interests pursued by the controller which are not overridden by the interests or rights and freedoms of the data subject, and the controller has assessed all the circumstances surrounding the data transfer and has on the basis of that assessment provided suitable safeguards with regard to the protection of personal data. The controller shall inform the supervisory authority of the transfer. The controller shall, in addition to providing the information referred to in Articles 13 and 14, inform the data subject of the transfer and on the compelling legitimate interests pursued. 2. A transfer pursuant to point (g) of the first subparagraph of paragraph 1 shall not involve the entirety of the personal data or entire categories of the personal data contained in the register. Where the register is intended for consultation by persons having a legitimate interest, the transfer shall be made only at the request of those persons or if they are to be the recipients. 3. Points (a), (b) and (c) of the first subparagraph of paragraph 1 and the second subparagraph thereof shall not apply to activities carried out by public authorities in the exercise of their public powers. 4. The public interest referred to in point (d) of the first subparagraph of paragraph 1 shall be recognised in Union law or in the law of the Member State to which the controller is subject. 5. In the absence of an adequacy decision, Union or Member State law may, for important reasons of public interest, expressly set limits to the transfer of specific categories of personal data to a third country or an international organisation. Member States shall notify such provisions to the Commission. 6. The controller or processor shall document the assessment as well as the suitable safeguards referred to in the second subparagraph of paragraph 1 of this Article in the records referred to in Article 30. Article 50 International cooperation for the protection of personal data In relation to third countries and international organisations, the Commission and supervisory authorities shall take appropriate steps to: (a) develop international cooperation mechanisms to facilitate the effective enforcement of legislation for the protection of personal data; (b) provide international mutual assistance in the enforcement of legislation for the protection of personal data, including through notification, complaint referral, investigative assistance and information exchange, subject to appropriate safeguards for the protection of personal data and other fundamental rights and freedoms; (c) engage relevant stakeholders in discussion and activities aimed at furthering international cooperation in the enforcement of legislation for the protection of personal data; (d) promote the exchange and documentation of personal data protection legislation and practice, including on jurisdictional conflicts with third countries. CHAPTER VI Independent supervisory authorities Section 1 Independent status Article 51 Supervisory authority 1. Each Member State shall provide for one or more independent public authorities to be responsible for monitoring the application of this Regulation, in order to protect the fundamental rights and freedoms of natural persons in relation to processing and to facilitate the free flow of personal data within the Union (\u2018supervisory authority\u2019). 2. Each supervisory authority shall contribute to the consistent application of this Regulation throughout the Union. For that purpose, the supervisory authorities shall cooperate with each other and the Commission in accordance with Chapter VII. 3. Where more than one supervisory authority is established in a Member State, that Member State shall designate the supervisory authority which is to represent those authorities in the Board and shall set out the mechanism to ensure compliance by the other authorities with the rules relating to the consistency mechanism referred to in Article 63. 4. Each Member State shall notify to the Commission the provisions of its law which it adopts pursuant to this Chapter, by 25 May 2018 and, without delay, any subsequent amendment affecting them. Article 52 Independence 1. Each supervisory authority shall act with complete independence in performing its tasks and exercising its powers in accordance with this Regulation. 2. The member or members of each supervisory authority shall, in the performance of their tasks and exercise of their powers in accordance with this Regulation, remain free from external influence, whether direct or indirect, and shall neither seek nor take instructions from anybody. 3. Member or members of each supervisory authority shall refrain from any action incompatible with their duties and shall not, during their term of office, engage in any incompatible occupation, whether gainful or not. 4. Each Member State shall ensure that each supervisory authority is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers, including those to be carried out in the context of mutual assistance, cooperation and participation in the Board. 5. Each Member State shall ensure that each supervisory authority chooses and has its own staff which shall be subject to the exclusive direction of the member or members of the supervisory authority concerned. 6. Each Member State shall ensure that each supervisory authority is subject to financial control which does not affect its independence and that it has separate, public annual budgets, which may be part of the overall state or national budget. Article 53 General conditions for the members of the supervisory authority 1. Member States shall provide for each member of their supervisory authorities to be appointed by means of a transparent procedure by: \u2014 their parliament; \u2014 their government; \u2014 their head of State; or \u2014 an independent body entrusted with the appointment under Member State law. 2. Each member shall have the qualifications, experience and skills, in particular in the area of the protection of personal data, required to perform its duties and exercise its powers. 3. The duties of a member shall end in the event of the expiry of the term of office, resignation or compulsory retirement, in accordance with the law of the Member State concerned. 4. A member shall be dismissed only in cases of serious misconduct or if the member no longer fulfils the conditions required for the performance of the duties. Article 54 Rules on the establishment of the supervisory authority 1. Each Member State shall provide by law for all of the following: (a) the establishment of each supervisory authority; (b) the qualifications and eligibility conditions required to be appointed as member of each supervisory authority; (c) the rules and procedures for the appointment of the member or members of each supervisory authority; (d) the duration of the term of the member or members of each supervisory authority of no less than four years, except for the first appointment after 24 May 2016, part of which may take place for a shorter period where that is necessary to protect the independence of the supervisory authority by means of a staggered appointment procedure; (e) whether and, if so, for how many terms the member or members of each supervisory authority is eligible for reappointment; (f) the conditions governing the obligations of the member or members and staff of each supervisory authority, prohibitions on actions, occupations and benefits incompatible therewith during and after the term of office and rules governing the cessation of employment. 2. The member or members and the staff of each supervisory authority shall, in accordance with Union or Member State law, be subject to a duty of professional secrecy both during and after their term of office, with regard to any confidential information which has come to their knowledge in the course of the performance of their tasks or exercise of their powers. During their term of office, that duty of professional secrecy shall in particular apply to reporting by natural persons of infringements of this Regulation. Section 2 Competence, tasks and powers Article 55 Competence 1. Each supervisory authority shall be competent for the performance of the tasks assigned to and the exercise of the powers conferred on it in accordance with this Regulation on the territory of its own Member State. 2. Where processing is carried out by public authorities or private bodies acting on the basis of point (c) or (e) of Article 6(1), the supervisory authority of the Member State concerned shall be competent. In such cases Article 56 does not apply. 3. Supervisory authorities shall not be competent to supervise processing operations of courts acting in their judicial capacity. Article 56 Competence of the lead supervisory authority 1. Without prejudice to Article 55, the supervisory authority of the main establishment or of the single establishment of the controller or processor shall be competent to act as lead supervisory authority for the cross-border processing carried out by that controller or processor in accordance with the procedure provided in Article 60. 2. By derogation from paragraph 1, each supervisory authority shall be competent to handle a complaint lodged with it or a possible infringement of this Regulation, if the subject matter relates only to an establishment in its Member State or substantially affects data subjects only in its Member State. 3. In the cases referred to in paragraph 2 of this Article, the supervisory authority shall inform the lead supervisory authority without delay on that matter. Within a period of three weeks after being informed the lead supervisory authority shall decide whether or not it will handle the case in accordance with the procedure provided in Article 60, taking into account whether or not there is an establishment of the controller or processor in the Member State of which the supervisory authority informed it. 4. Where the lead supervisory authority decides to handle the case, the procedure provided in Article 60 shall apply. The supervisory authority which informed the lead supervisory authority may submit to the lead supervisory authority a draft for a decision. The lead supervisory authority shall take utmost account of that draft when preparing the draft decision referred to in Article 60(3). 5. Where the lead supervisory authority decides not to handle the case, the supervisory authority which informed the lead supervisory authority shall handle it according to Articles 61 and 62. 6. The lead supervisory authority shall be the sole interlocutor of the controller or processor for the cross-border processing carried out by that controller or processor. Article 57 Tasks 1. Without prejudice to other tasks set out under this Regulation, each supervisory authority shall on its territory: (a) monitor and enforce the application of this Regulation; (b) promote public awareness and understanding of the risks, rules, safeguards and rights in relation to processing. Activities addressed specifically to children shall receive specific attention; (c) advise, in accordance with Member State law, the national parliament, the government, and other institutions and bodies on legislative and administrative measures relating to the protection of natural persons' rights and freedoms with regard to processing; (d) promote the awareness of controllers and processors of their obligations under this Regulation; (e) upon request, provide information to any data subject concerning the exercise of their rights under this Regulation and, if appropriate, cooperate with the supervisory authorities in other Member States to that end; (f) handle complaints lodged by a data subject, or by a body, organisation or association in accordance with Article 80, and investigate, to the extent appropriate, the subject matter of the complaint and inform the complainant of the progress and the outcome of the investigation within a reasonable period, in particular if further investigation or coordination with another supervisory authority is necessary; (g) cooperate with, including sharing information and provide mutual assistance to, other supervisory authorities with a view to ensuring the consistency of application and enforcement of this Regulation; (h) conduct investigations on the application of this Regulation, including on the basis of information received from another supervisory authority or other public authority; (i) monitor relevant developments, insofar as they have an impact on the protection of personal data, in particular the development of information and communication technologies and commercial practices; (j) adopt standard contractual clauses referred to in Article 28(8) and in point (d) of Article 46(2); (k) establish and maintain a list in relation to the requirement for data protection impact assessment pursuant to Article 35(4); (l) give advice on the processing operations referred to in Article 36(2); (m) encourage the drawing up of codes of conduct pursuant to Article 40(1) and provide an opinion and approve such codes of conduct which provide sufficient safeguards, pursuant to Article 40(5); (n) encourage the establishment of data protection certification mechanisms and of data protection seals and marks pursuant to Article 42(1), and approve the criteria of certification pursuant to Article 42(5); (o) where applicable, carry out a periodic review of certifications issued in accordance with Article 42(7); (p) draft and publish the criteria for accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification body pursuant to Article 43; (q) conduct the accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification body pursuant to Article 43; (r) authorise contractual clauses and provisions referred to in Article 46(3); (s) approve binding corporate rules pursuant to Article 47; (t) contribute to the activities of the Board; (u) keep internal records of infringements of this Regulation and of measures taken in accordance with Article 58(2); and (v) fulfil any other tasks related to the protection of personal data. 2. Each supervisory authority shall facilitate the submission of complaints referred to in point (f) of paragraph 1 by measures such as a complaint submission form which can also be completed electronically, without excluding other means of communication. 3. The performance of the tasks of each supervisory authority shall be free of charge for the data subject and, where applicable, for the data protection officer. 4. Where requests are manifestly unfounded or excessive, in particular because of their repetitive character, the supervisory authority may charge a reasonable fee based on administrative costs, or refuse to act on the request. The supervisory authority shall bear the burden of demonstrating the manifestly unfounded or excessive character of the request. Article 58 Powers 1. Each supervisory authority shall have all of the following investigative powers: (a) to order the controller and the processor, and, where applicable, the controller's or the processor's representative to provide any information it requires for the performance of its tasks; (b) to carry out investigations in the form of data protection audits; (c) to carry out a review on certifications issued pursuant to Article 42(7); (d) to notify the controller or the processor of an alleged infringement of this Regulation; (e) to obtain, from the controller and the processor, access to all personal data and to all information necessary for the performance of its tasks; (f) to obtain access to any premises of the controller and the processor, including to any data processing equipment and means, in accordance with Union or Member State procedural law. 2. Each supervisory authority shall have all of the following corrective powers: (a) to issue warnings to a controller or processor that intended processing operations are likely to infringe provisions of this Regulation; (b) to issue reprimands to a controller or a processor where processing operations have infringed provisions of this Regulation; (c) to order the controller or the processor to comply with the data subject's requests to exercise his or her rights pursuant to this Regulation; (d) to order the controller or processor to bring processing operations into compliance with the provisions of this Regulation, where appropriate, in a specified manner and within a specified period; (e) to order the controller to communicate a personal data breach to the data subject; (f) to impose a temporary or definitive limitation including a ban on processing; (g) to order the rectification or erasure of personal data or restriction of processing pursuant to Articles 16, 17 and 18 and the notification of such actions to recipients to whom the personal data have been disclosed pursuant to Article 17(2) and Article 19; (h) to withdraw a certification or to order the certification body to withdraw a certification issued pursuant to Articles 42 and 43, or to order the certification body not to issue certification if the requirements for the certification are not or are no longer met; (i) to impose an administrative fine pursuant to Article 83, in addition to, or instead of measures referred to in this paragraph, depending on the circumstances of each individual case; (j) to order the suspension of data flows to a recipient in a third country or to an international organisation. 3. Each supervisory authority shall have all of the following authorisation and advisory powers: (a) to advise the controller in accordance with the prior consultation procedure referred to in Article 36; (b) to issue, on its own initiative or on request, opinions to the national parliament, the Member State government or, in accordance with Member State law, to other institutions and bodies as well as to the public on any issue related to the protection of personal data; (c) to authorise processing referred to in Article 36(5), if the law of the Member State requires such prior authorisation; (d) to issue an opinion and approve draft codes of conduct pursuant to Article 40(5); (e) to accredit certification bodies pursuant to Article 43; (f) to issue certifications and approve criteria of certification in accordance with Article 42(5); (g) to adopt standard data protection clauses referred to in Article 28(8) and in point (d) of Article 46(2); (h) to authorise contractual clauses referred to in point (a) of Article 46(3); (i) to authorise administrative arrangements referred to in point (b) of Article 46(3); (j) to approve binding corporate rules pursuant to Article 47. 4. The exercise of the powers conferred on the supervisory authority pursuant to this Article shall be subject to appropriate safeguards, including effective judicial remedy and due process, set out in Union and Member State law in accordance with the Charter. 5. Each Member State shall provide by law that its supervisory authority shall have the power to bring infringements of this Regulation to the attention of the judicial authorities and where appropriate, to commence or engage otherwise in legal proceedings, in order to enforce the provisions of this Regulation. 6. Each Member State may provide by law that its supervisory authority shall have additional powers to those referred to in paragraphs 1, 2 and 3. The exercise of those powers shall not impair the effective operation of Chapter VII. Article 59 Activity reports Each supervisory authority shall draw up an annual report on its activities, which may include a list of types of infringement notified and types of measures taken in accordance with Article 58(2). Those reports shall be transmitted to the national parliament, the government and other authorities as designated by Member State law. They shall be made available to the public, to the Commission and to the Board. CHAPTER VII Cooperation and consistency Section 1 Cooperation Article 60 Cooperation between the lead supervisory authority and the other supervisory authorities concerned 1. The lead supervisory authority shall cooperate with the other supervisory authorities concerned in accordance with this Article in an endeavour to reach consensus. The lead supervisory authority and the supervisory authorities concerned shall exchange all relevant information with each other. 2. The lead supervisory authority may request at any time other supervisory authorities concerned to provide mutual assistance pursuant to Article 61 and may conduct joint operations pursuant to Article 62, in particular for carrying out investigations or for monitoring the implementation of a measure concerning a controller or processor established in another Member State. 3. The lead supervisory authority shall, without delay, communicate the relevant information on the matter to the other supervisory authorities concerned. It shall without delay submit a draft decision to the other supervisory authorities concerned for their opinion and take due account of their views. 4. Where any of the other supervisory authorities concerned within a period of four weeks after having been consulted in accordance with paragraph 3 of this Article, expresses a relevant and reasoned objection to the draft decision, the lead supervisory authority shall, if it does not follow the relevant and reasoned objection or is of the opinion that the objection is not relevant or reasoned, submit the matter to the consistency mechanism referred to in Article 63. 5. Where the lead supervisory authority intends to follow the relevant and reasoned objection made, it shall submit to the other supervisory authorities concerned a revised draft decision for their opinion. That revised draft decision shall be subject to the procedure referred to in paragraph 4 within a period of two weeks. 6. Where none of the other supervisory authorities concerned has objected to the draft decision submitted by the lead supervisory authority within the period referred to in paragraphs 4 and 5, the lead supervisory authority and the supervisory authorities concerned shall be deemed to be in agreement with that draft decision and shall be bound by it. 7. The lead supervisory authority shall adopt and notify the decision to the main establishment or single establishment of the controller or processor, as the case may be and inform the other supervisory authorities concerned and the Board of the decision in question, including a summary of the relevant facts and grounds. The supervisory authority with which a complaint has been lodged shall inform the complainant on the decision. 8. By derogation from paragraph 7, where a complaint is dismissed or rejected, the supervisory authority with which the complaint was lodged shall adopt the decision and notify it to the complainant and shall inform the controller thereof. 9. Where the lead supervisory authority and the supervisory authorities concerned agree to dismiss or reject parts of a complaint and to act on other parts of that complaint, a separate decision shall be adopted for each of those parts of the matter. The lead supervisory authority shall adopt the decision for the part concerning actions in relation to the controller, shall notify it to the main establishment or single establishment of the controller or processor on the territory of its Member State and shall inform the complainant thereof, while the supervisory authority of the complainant shall adopt the decision for the part concerning dismissal or rejection of that complaint, and shall notify it to that complainant and shall inform the controller or processor thereof. 10. After being notified of the decision of the lead supervisory authority pursuant to paragraphs 7 and 9, the controller or processor shall take the necessary measures to ensure compliance with the decision as regards processing activities in the context of all its establishments in the Union. The controller or processor shall notify the measures taken for complying with the decision to the lead supervisory authority, which shall inform the other supervisory authorities concerned. 11. Where, in exceptional circumstances, a supervisory authority concerned has reasons to consider that there is an urgent need to act in order to protect the interests of data subjects, the urgency procedure referred to in Article 66 shall apply. 12. The lead supervisory authority and the other supervisory authorities concerned shall supply the information required under this Article to each other by electronic means, using a standardised format. Article 61 Mutual assistance 1. Supervisory authorities shall provide each other with relevant information and mutual assistance in order to implement and apply this Regulation in a consistent manner, and shall put in place measures for effective cooperation with one another. Mutual assistance shall cover, in particular, information requests and supervisory measures, such as requests to carry out prior authorisations and consultations, inspections and investigations. 2. Each supervisory authority shall take all appropriate measures required to reply to a request of another supervisory authority without undue delay and no later than one month after receiving the request. Such measures may include, in particular, the transmission of relevant information on the conduct of an investigation. 3. Requests for assistance shall contain all the necessary information, including the purpose of and reasons for the request. Information exchanged shall be used only for the purpose for which it was requested. 4. The requested supervisory authority shall not refuse to comply with the request unless: (a) it is not competent for the subject-matter of the request or for the measures it is requested to execute; or (b) compliance with the request would infringe this Regulation or Union or Member State law to which the supervisory authority receiving the request is subject. 5. The requested supervisory authority shall inform the requesting supervisory authority of the results or, as the case may be, of the progress of the measures taken in order to respond to the request. The requested supervisory authority shall provide reasons for any refusal to comply with a request pursuant to paragraph 4. 6. Requested supervisory authorities shall, as a rule, supply the information requested by other supervisory authorities by electronic means, using a standardised format. 7. Requested supervisory authorities shall not charge a fee for any action taken by them pursuant to a request for mutual assistance. Supervisory authorities may agree on rules to indemnify each other for specific expenditure arising from the provision of mutual assistance in exceptional circumstances. 8. Where a supervisory authority does not provide the information referred to in paragraph 5 of this Article within one month of receiving the request of another supervisory authority, the requesting supervisory authority may adopt a provisional measure on the territory of its Member State in accordance with Article 55(1). In that case, the urgent need to act under Article 66(1) shall be presumed to be met and require an urgent binding decision from the Board pursuant to Article 66(2). 9. The Commission may, by means of implementing acts, specify the format and procedures for mutual assistance referred to in this Article and the arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board, in particular the standardised format referred to in paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2). Article 62 Joint operations of supervisory authorities 1. The supervisory authorities shall, where appropriate, conduct joint operations including joint investigations and joint enforcement measures in which members or staff of the supervisory authorities of other Member States are involved. 2. Where the controller or processor has establishments in several Member States or where a significant number of data subjects in more than one Member State are likely to be substantially affected by processing operations, a supervisory authority of each of those Member States shall have the right to participate in joint operations. The supervisory authority which is competent pursuant to Article 56(1) or (4) shall invite the supervisory authority of each of those Member States to take part in the joint operations and shall respond without delay to the request of a supervisory authority to participate. 3. A supervisory authority may, in accordance with Member State law, and with the seconding supervisory authority's authorisation, confer powers, including investigative powers on the seconding supervisory authority's members or staff involved in joint operations or, in so far as the law of the Member State of the host supervisory authority permits, allow the seconding supervisory authority's members or staff to exercise their investigative powers in accordance with the law of the Member State of the seconding supervisory authority. Such investigative powers may be exercised only under the guidance and in the presence of members or staff of the host supervisory authority. The seconding supervisory authority's members or staff shall be subject to the Member State law of the host supervisory authority. 4. Where, in accordance with paragraph 1, staff of a seconding supervisory authority operate in another Member State, the Member State of the host supervisory authority shall assume responsibility for their actions, including liability, for any damage caused by them during their operations, in accordance with the law of the Member State in whose territory they are operating. 5. The Member State in whose territory the damage was caused shall make good such damage under the conditions applicable to damage caused by its own staff. The Member State of the seconding supervisory authority whose staff has caused damage to any person in the territory of another Member State shall reimburse that other Member State in full any sums it has paid to the persons entitled on their behalf. 6. Without prejudice to the exercise of its rights vis-\u00e0-vis third parties and with the exception of paragraph 5, each Member State shall refrain, in the case provided for in paragraph 1, from requesting reimbursement from another Member State in relation to damage referred to in paragraph 4. 7. Where a joint operation is intended and a supervisory authority does not, within one month, comply with the obligation laid down in the second sentence of paragraph 2 of this Article, the other supervisory authorities may adopt a provisional measure on the territory of its Member State in accordance with Article 55. In that case, the urgent need to act under Article 66(1) shall be presumed to be met and require an opinion or an urgent binding decision from the Board pursuant to Article 66(2). Section 2 Consistency Article 63 Consistency mechanism In order to contribute to the consistent application of this Regulation throughout the Union, the supervisory authorities shall cooperate with each other and, where relevant, with the Commission, through the consistency mechanism as set out in this Section. Article 64 Opinion of the Board 1. The Board shall issue an opinion where a competent supervisory authority intends to adopt any of the measures below. To that end, the competent supervisory authority shall communicate the draft decision to the Board, when it: (a) aims to adopt a list of the processing operations subject to the requirement for a data protection impact assessment pursuant to Article 35(4); (b) concerns a matter pursuant to Article 40(7) whether a draft code of conduct or an amendment or extension to a code of conduct complies with this Regulation; (c) aims to approve the criteria for accreditation of a body pursuant to Article 41(3) or a certification body pursuant to Article 43(3); (d) aims to determine standard data protection clauses referred to in point (d) of Article 46(2) and in Article 28(8); (e) aims to authorise contractual clauses referred to in point (a) of Article 46(3); or (f) aims to approve binding corporate rules within the meaning of Article 47. 2. Any supervisory authority, the Chair of the Board or the Commission may request that any matter of general application or producing effects in more than one Member State be examined by the Board with a view to obtaining an opinion, in particular where a competent supervisory authority does not comply with the obligations for mutual assistance in accordance with Article 61 or for joint operations in accordance with Article 62. 3. In the cases referred to in paragraphs 1 and 2, the Board shall issue an opinion on the matter submitted to it provided that it has not already issued an opinion on the same matter. That opinion shall be adopted within eight weeks by simple majority of the members of the Board. That period may be extended by a further six weeks, taking into account the complexity of the subject matter. Regarding the draft decision referred to in paragraph 1 circulated to the members of the Board in accordance with paragraph 5, a member which has not objected within a reasonable period indicated by the Chair, shall be deemed to be in agreement with the draft decision. 4. Supervisory authorities and the Commission shall, without undue delay, communicate by electronic means to the Board, using a standardised format any relevant information, including as the case may be a summary of the facts, the draft decision, the grounds which make the enactment of such measure necessary, and the views of other supervisory authorities concerned. 5. The Chair of the Board shall, without undue, delay inform by electronic means: (a) the members of the Board and the Commission of any relevant information which has been communicated to it using a standardised format. The secretariat of the Board shall, where necessary, provide translations of relevant information; and (b) the supervisory authority referred to, as the case may be, in paragraphs 1 and 2, and the Commission of the opinion and make it public. 6. The competent supervisory authority shall not adopt its draft decision referred to in paragraph 1 within the period referred to in paragraph 3. 7. The supervisory authority referred to in paragraph 1 shall take utmost account of the opinion of the Board and shall, within two weeks after receiving the opinion, communicate to the Chair of the Board by electronic means whether it will maintain or amend its draft decision and, if any, the amended draft decision, using a standardised format. 8. Where the supervisory authority concerned informs the Chair of the Board within the period referred to in paragraph 7 of this Article that it does not intend to follow the opinion of the Board, in whole or in part, providing the relevant grounds, Article 65(1) shall apply. Article 65 Dispute resolution by the Board 1. In order to ensure the correct and consistent application of this Regulation in individual cases, the Board shall adopt a binding decision in the following cases: (a) where, in a case referred to in Article 60(4), a supervisory authority concerned has raised a relevant and reasoned objection to a draft decision of the lead authority or the lead authority has rejected such an objection as being not relevant or reasoned. The binding decision shall concern all the matters which are the subject of the relevant and reasoned objection, in particular whether there is an infringement of this Regulation; (b) where there are conflicting views on which of the supervisory authorities concerned is competent for the main establishment; (c) where a competent supervisory authority does not request the opinion of the Board in the cases referred to in Article 64(1), or does not follow the opinion of the Board issued under Article 64. In that case, any supervisory authority concerned or the Commission may communicate the matter to the Board. 2. The decision referred to in paragraph 1 shall be adopted within one month from the referral of the subject-matter by a two-thirds majority of the members of the Board. That period may be extended by a further month on account of the complexity of the subject-matter. The decision referred to in paragraph 1 shall be reasoned and addressed to the lead supervisory authority and all the supervisory authorities concerned and binding on them. 3. Where the Board has been unable to adopt a decision within the periods referred to in paragraph 2, it shall adopt its decision within two weeks following the expiration of the second month referred to in paragraph 2 by a simple majority of the members of the Board. Where the members of the Board are split, the decision shall by adopted by the vote of its Chair. 4. The supervisory authorities concerned shall not adopt a decision on the subject matter submitted to the Board under paragraph 1 during the periods referred to in paragraphs 2 and 3. 5. The Chair of the Board shall notify, without undue delay, the decision referred to in paragraph 1 to the supervisory authorities concerned. It shall inform the Commission thereof. The decision shall be published on the website of the Board without delay after the supervisory authority has notified the final decision referred to in paragraph 6. 6. The lead supervisory authority or, as the case may be, the supervisory authority with which the complaint has been lodged shall adopt its final decision on the basis of the decision referred to in paragraph 1 of this Article, without undue delay and at the latest by one month after the Board has notified its decision. The lead supervisory authority or, as the case may be, the supervisory authority with which the complaint has been lodged, shall inform the Board of the date when its final decision is notified respectively to the controller or the processor and to the data subject. The final decision of the supervisory authorities concerned shall be adopted under the terms of Article 60(7), (8) and (9). The final decision shall refer to the decision referred to in paragraph 1 of this Article and shall specify that the decision referred to in that paragraph will be published on the website of the Board in accordance with paragraph 5 of this Article. The final decision shall attach the decision referred to in paragraph 1 of this Article. Article 66 Urgency procedure 1. In exceptional circumstances, where a supervisory authority concerned considers that there is an urgent need to act in order to protect the rights and freedoms of data subjects, it may, by way of derogation from the consistency mechanism referred to in Articles 63, 64 and 65 or the procedure referred to in Article 60, immediately adopt provisional measures intended to produce legal effects on its own territory with a specified period of validity which shall not exceed three months. The supervisory authority shall, without delay, communicate those measures and the reasons for adopting them to the other supervisory authorities concerned, to the Board and to the Commission. 2. Where a supervisory authority has taken a measure pursuant to paragraph 1 and considers that final measures need urgently be adopted, it may request an urgent opinion or an urgent binding decision from the Board, giving reasons for requesting such opinion or decision. 3. Any supervisory authority may request an urgent opinion or an urgent binding decision, as the case may be, from the Board where a competent supervisory authority has not taken an appropriate measure in a situation where there is an urgent need to act, in order to protect the rights and freedoms of data subjects, giving reasons for requesting such opinion or decision, including for the urgent need to act. 4. By derogation from Article 64(3) and Article 65(2), an urgent opinion or an urgent binding decision referred to in paragraphs 2 and 3 of this Article shall be adopted within two weeks by simple majority of the members of the Board. Article 67 Exchange of information The Commission may adopt implementing acts of general scope in order to specify the arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board, in particular the standardised format referred to in Article 64. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2). Section 3 European data protection board Article 68 European Data Protection Board 1. The European Data Protection Board (the \u2018Board\u2019) is hereby established as a body of the Union and shall have legal personality. 2. The Board shall be represented by its Chair. 3. The Board shall be composed of the head of one supervisory authority of each Member State and of the European Data Protection Supervisor, or their respective representatives. 4. Where in a Member State more than one supervisory authority is responsible for monitoring the application of the provisions pursuant to this Regulation, a joint representative shall be appointed in accordance with that Member State's law. 5. The Commission shall have the right to participate in the activities and meetings of the Board without voting right. The Commission shall designate a representative. The Chair of the Board shall communicate to the Commission the activities of the Board. 6. In the cases referred to in Article 65, the European Data Protection Supervisor shall have voting rights only on decisions which concern principles and rules applicable to the Union institutions, bodies, offices and agencies which correspond in substance to those of this Regulation. Article 69 Independence 1. The Board shall act independently when performing its tasks or exercising its powers pursuant to Articles 70 and 71. 2. Without prejudice to requests by the Commission referred to in point (b) of Article 70(1) and in Article 70(2), the Board shall, in the performance of its tasks or the exercise of its powers, neither seek nor take instructions from anybody. Article 70 Tasks of the Board 1. The Board shall ensure the consistent application of this Regulation. To that end, the Board shall, on its own initiative or, where relevant, at the request of the Commission, in particular: (a) monitor and ensure the correct application of this Regulation in the cases provided for in Articles 64 and 65 without prejudice to the tasks of national supervisory authorities; (b) advise the Commission on any issue related to the protection of personal data in the Union, including on any proposed amendment of this Regulation; (c) advise the Commission on the format and procedures for the exchange of information between controllers, processors and supervisory authorities for binding corporate rules; (d) issue guidelines, recommendations, and best practices on procedures for erasing links, copies or replications of personal data from publicly available communication services as referred to in Article 17(2); (e) examine, on its own initiative, on request of one of its members or on request of the Commission, any question covering the application of this Regulation and issue guidelines, recommendations and best practices in order to encourage consistent application of this Regulation; (f) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for further specifying the criteria and conditions for decisions based on profiling pursuant to Article 22(2); (g) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for establishing the personal data breaches and determining the undue delay referred to in Article 33(1) and (2) and for the particular circumstances in which a controller or a processor is required to notify the personal data breach; (h) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph as to the circumstances in which a personal data breach is likely to result in a high risk to the rights and freedoms of the natural persons referred to in Article 34(1). (i) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for the purpose of further specifying the criteria and requirements for personal data transfers based on binding corporate rules adhered to by controllers and binding corporate rules adhered to by processors and on further necessary requirements to ensure the protection of personal data of the data subjects concerned referred to in Article 47; (j) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for the purpose of further specifying the criteria and requirements for the personal data transfers on the basis of Article 49(1); (k) draw up guidelines for supervisory authorities concerning the application of measures referred to in Article 58(1), (2) and (3) and the setting of administrative fines pursuant to Article 83; (l) review the practical application of the guidelines, recommendations and best practices referred to in points (e) and (f); (m) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for establishing common procedures for reporting by natural persons of infringements of this Regulation pursuant to Article 54(2); (n) encourage the drawing-up of codes of conduct and the establishment of data protection certification mechanisms and data protection seals and marks pursuant to Articles 40 and 42; (o) carry out the accreditation of certification bodies and its periodic review pursuant to Article 43 and maintain a public register of accredited bodies pursuant to Article 43(6) and of the accredited controllers or processors established in third countries pursuant to Article 42(7); (p) specify the requirements referred to in Article 43(3) with a view to the accreditation of certification bodies under Article 42; (q) provide the Commission with an opinion on the certification requirements referred to in Article 43(8); (r) provide the Commission with an opinion on the icons referred to in Article 12(7); (s) provide the Commission with an opinion for the assessment of the adequacy of the level of protection in a third country or international organisation, including for the assessment whether a third country, a territory or one or more specified sectors within that third country, or an international organisation no longer ensures an adequate level of protection. To that end, the Commission shall provide the Board with all necessary documentation, including correspondence with the government of the third country, with regard to that third country, territory or specified sector, or with the international organisation. (t) issue opinions on draft decisions of supervisory authorities pursuant to the consistency mechanism referred to in Article 64(1), on matters submitted pursuant to Article 64(2) and to issue binding decisions pursuant to Article 65, including in cases referred to in Article 66; (u) promote the cooperation and the effective bilateral and multilateral exchange of information and best practices between the supervisory authorities; (v) promote common training programmes and facilitate personnel exchanges between the supervisory authorities and, where appropriate, with the supervisory authorities of third countries or with international organisations; (w) promote the exchange of knowledge and documentation on data protection legislation and practice with data protection supervisory authorities worldwide. (x) issue opinions on codes of conduct drawn up at Union level pursuant to Article 40(9); and (y) maintain a publicly accessible electronic register of decisions taken by supervisory authorities and courts on issues handled in the consistency mechanism. 2. Where the Commission requests advice from the Board, it may indicate a time limit, taking into account the urgency of the matter. 3. The Board shall forward its opinions, guidelines, recommendations, and best practices to the Commission and to the committee referred to in Article 93 and make them public. 4. The Board shall, where appropriate, consult interested parties and give them the opportunity to comment within a reasonable period. The Board shall, without prejudice to Article 76, make the results of the consultation procedure publicly available. Article 71 Reports 1. The Board shall draw up an annual report regarding the protection of natural persons with regard to processing in the Union and, where relevant, in third countries and international organisations. The report shall be made public and be transmitted to the European Parliament, to the Council and to the Commission. 2. The annual report shall include a review of the practical application of the guidelines, recommendations and best practices referred to in point (l) of Article 70(1) as well as of the binding decisions referred to in Article 65. Article 72 Procedure 1. The Board shall take decisions by a simple majority of its members, unless otherwise provided for in this Regulation. 2. The Board shall adopt its own rules of procedure by a two-thirds majority of its members and organise its own operational arrangements. Article 73 Chair 1. The Board shall elect a chair and two deputy chairs from amongst its members by simple majority. 2. The term of office of the Chair and of the deputy chairs shall be five years and be renewable once. Article 74 Tasks of the Chair 1. The Chair shall have the following tasks: (a) to convene the meetings of the Board and prepare its agenda; (b) to notify decisions adopted by the Board pursuant to Article 65 to the lead supervisory authority and the supervisory authorities concerned; (c) to ensure the timely performance of the tasks of the Board, in particular in relation to the consistency mechanism referred to in Article 63. 2. The Board shall lay down the allocation of tasks between the Chair and the deputy chairs in its rules of procedure. Article 75 Secretariat 1. The Board shall have a secretariat, which shall be provided by the European Data Protection Supervisor. 2. The secretariat shall perform its tasks exclusively under the instructions of the Chair of the Board. 3. The staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this Regulation shall be subject to separate reporting lines from the staff involved in carrying out tasks conferred on the European Data Protection Supervisor. 4. Where appropriate, the Board and the European Data Protection Supervisor shall establish and publish a Memorandum of Understanding implementing this Article, determining the terms of their cooperation, and applicable to the staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this Regulation. 5. The secretariat shall provide analytical, administrative and logistical support to the Board. 6. The secretariat shall be responsible in particular for: (a) the day-to-day business of the Board; (b) communication between the members of the Board, its Chair and the Commission; (c) communication with other institutions and the public; (d) the use of electronic means for the internal and external communication; (e) the translation of relevant information; (f) the preparation and follow-up of the meetings of the Board; (g) the preparation, drafting and publication of opinions, decisions on the settlement of disputes between supervisory authorities and other texts adopted by the Board. Article 76 Confidentiality 1. The discussions of the Board shall be confidential where the Board deems it necessary, as provided for in its rules of procedure. 2. Access to documents submitted to members of the Board, experts and representatives of third parties shall be governed by Regulation (EC) No 1049/2001 of the European Parliament and of the Council (21). CHAPTER VIII Remedies, liability and penalties Article 77 Right to lodge a complaint with a supervisory authority 1. Without prejudice to any other administrative or judicial remedy, every data subject shall have the right to lodge a complaint with a supervisory authority, in particular in the Member State of his or her habitual residence, place of work or place of the alleged infringement if the data subject considers that the processing of personal data relating to him or her infringes this Regulation. 2. The supervisory authority with which the complaint has been lodged shall inform the complainant on the progress and the outcome of the complaint including the possibility of a judicial remedy pursuant to Article 78. Article 78 Right to an effective judicial remedy against a supervisory authority 1. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy against a legally binding decision of a supervisory authority concerning them. 2. Without prejudice to any other administrative or non-judicial remedy, each data subject shall have the right to a an effective judicial remedy where the supervisory authority which is competent pursuant to Articles 55 and 56 does not handle a complaint or does not inform the data subject within three months on the progress or outcome of the complaint lodged pursuant to Article 77. 3. Proceedings against a supervisory authority shall be brought before the courts of the Member State where the supervisory authority is established. 4. Where proceedings are brought against a decision of a supervisory authority which was preceded by an opinion or a decision of the Board in the consistency mechanism, the supervisory authority shall forward that opinion or decision to the court. Article 79 Right to an effective judicial remedy against a controller or processor 1. Without prejudice to any available administrative or non-judicial remedy, including the right to lodge a complaint with a supervisory authority pursuant to Article 77, each data subject shall have the right to an effective judicial remedy where he or she considers that his or her rights under this Regulation have been infringed as a result of the processing of his or her personal data in non-compliance with this Regulation. 2. Proceedings against a controller or a processor shall be brought before the courts of the Member State where the controller or processor has an establishment. Alternatively, such proceedings may be brought before the courts of the Member State where the data subject has his or her habitual residence, unless the controller or processor is a public authority of a Member State acting in the exercise of its public powers. Article 80 Representation of data subjects 1. The data subject shall have the right to mandate a not-for-profit body, organisation or association which has been properly constituted in accordance with the law of a Member State, has statutory objectives which are in the public interest, and is active in the field of the protection of data subjects' rights and freedoms with regard to the protection of their personal data to lodge the complaint on his or her behalf, to exercise the rights referred to in Articles 77, 78 and 79 on his or her behalf, and to exercise the right to receive compensation referred to in Article 82 on his or her behalf where provided for by Member State law. 2. Member States may provide that any body, organisation or association referred to in paragraph 1 of this Article, independently of a data subject's mandate, has the right to lodge, in that Member State, a complaint with the supervisory authority which is competent pursuant to Article 77 and to exercise the rights referred to in Articles 78 and 79 if it considers that the rights of a data subject under this Regulation have been infringed as a result of the processing. Article 81 Suspension of proceedings 1. Where a competent court of a Member State has information on proceedings, concerning the same subject matter as regards processing by the same controller or processor, that are pending in a court in another Member State, it shall contact that court in the other Member State to confirm the existence of such proceedings. 2. Where proceedings concerning the same subject matter as regards processing of the same controller or processor are pending in a court in another Member State, any competent court other than the court first seized may suspend its proceedings. 3. Where those proceedings are pending at first instance, any court other than the court first seized may also, on the application of one of the parties, decline jurisdiction if the court first seized has jurisdiction over the actions in question and its law permits the consolidation thereof. Article 82 Right to compensation and liability 1. Any person who has suffered material or non-material damage as a result of an infringement of this Regulation shall have the right to receive compensation from the controller or processor for the damage suffered. 2. Any controller involved in processing shall be liable for the damage caused by processing which infringes this Regulation. A processor shall be liable for the damage caused by processing only where it has not complied with obligations of this Regulation specifically directed to processors or where it has acted outside or contrary to lawful instructions of the controller. 3. A controller or processor shall be exempt from liability under paragraph 2 if it proves that it is not in any way responsible for the event giving rise to the damage. 4. Where more than one controller or processor, or both a controller and a processor, are involved in the same processing and where they are, under paragraphs 2 and 3, responsible for any damage caused by processing, each controller or processor shall be held liable for the entire damage in order to ensure effective compensation of the data subject. 5. Where a controller or processor has, in accordance with paragraph 4, paid full compensation for the damage suffered, that controller or processor shall be entitled to claim back from the other controllers or processors involved in the same processing that part of the compensation corresponding to their part of responsibility for the damage, in accordance with the conditions set out in paragraph 2. 6. Court proceedings for exercising the right to receive compensation shall be brought before the courts competent under the law of the Member State referred to in Article 79(2). Article 83 General conditions for imposing administrative fines 1. Each supervisory authority shall ensure that the imposition of administrative fines pursuant to this Article in respect of infringements of this Regulation referred to in paragraphs 4, 5 and 6 shall in each individual case be effective, proportionate and dissuasive. 2. Administrative fines shall, depending on the circumstances of each individual case, be imposed in addition to, or instead of, measures referred to in points (a) to (h) and (j) of Article 58(2). When deciding whether to impose an administrative fine and deciding on the amount of the administrative fine in each individual case due regard shall be given to the following: (a) the nature, gravity and duration of the infringement taking into account the nature scope or purpose of the processing concerned as well as the number of data subjects affected and the level of damage suffered by them; (b) the intentional or negligent character of the infringement; (c) any action taken by the controller or processor to mitigate the damage suffered by data subjects; (d) the degree of responsibility of the controller or processor taking into account technical and organisational measures implemented by them pursuant to Articles 25 and 32; (e) any relevant previous infringements by the controller or processor; (f) the degree of cooperation with the supervisory authority, in order to remedy the infringement and mitigate the possible adverse effects of the infringement; (g) the categories of personal data affected by the infringement; (h) the manner in which the infringement became known to the supervisory authority, in particular whether, and if so to what extent, the controller or processor notified the infringement; (i) where measures referred to in Article 58(2) have previously been ordered against the controller or processor concerned with regard to the same subject-matter, compliance with those measures; (j) adherence to approved codes of conduct pursuant to Article 40 or approved certification mechanisms pursuant to Article 42; and (k) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement. 3. If a controller or processor intentionally or negligently, for the same or linked processing operations, infringes several provisions of this Regulation, the total amount of the administrative fine shall not exceed the amount specified for the gravest infringement. 4. Infringements of the following provisions shall, in accordance with paragraph 2, be subject to administrative fines up to 10 000 000 EUR, or in the case of an undertaking, up to 2 % of the total worldwide annual turnover of the preceding financial year, whichever is higher: (a) the obligations of the controller and the processor pursuant to Articles 8, 11, 25 to 39 and 42 and 43; (b) the obligations of the certification body pursuant to Articles 42 and 43; (c) the obligations of the monitoring body pursuant to Article 41(4). 5. Infringements of the following provisions shall, in accordance with paragraph 2, be subject to administrative fines up to 20 000 000 EUR, or in the case of an undertaking, up to 4 % of the total worldwide annual turnover of the preceding financial year, whichever is higher: (a) the basic principles for processing, including conditions for consent, pursuant to Articles 5, 6, 7 and 9; (b) the data subjects' rights pursuant to Articles 12 to 22; (c) the transfers of personal data to a recipient in a third country or an international organisation pursuant to Articles 44 to 49; (d) any obligations pursuant to Member State law adopted under Chapter IX; (e) non-compliance with an order or a temporary or definitive limitation on processing or the suspension of data flows by the supervisory authority pursuant to Article 58(2) or failure to provide access in violation of Article 58(1). 6. Non-compliance with an order by the supervisory authority as referred to in Article 58(2) shall, in accordance with paragraph 2 of this Article, be subject to administrative fines up to 20 000 000 EUR, or in the case of an undertaking, up to 4 % of the total worldwide annual turnover of the preceding financial year, whichever is higher. 7. Without prejudice to the corrective powers of supervisory authorities pursuant to Article 58(2), each Member State may lay down the rules on whether and to what extent administrative fines may be imposed on public authorities and bodies established in that Member State. 8. The exercise by the supervisory authority of its powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and Member State law, including effective judicial remedy and due process. 9. Where the legal system of the Member State does not provide for administrative fines, this Article may be applied in such a manner that the fine is initiated by the competent supervisory authority and imposed by competent national courts, while ensuring that those legal remedies are effective and have an equivalent effect to the administrative fines imposed by supervisory authorities. In any event, the fines imposed shall be effective, proportionate and dissuasive. Those Member States shall notify to the Commission the provisions of their laws which they adopt pursuant to this paragraph by 25 May 2018 and, without delay, any subsequent amendment law or amendment affecting them. Article 84 Penalties 1. Member States shall lay down the rules on other penalties applicable to infringements of this Regulation in particular for infringements which are not subject to administrative fines pursuant to Article 83, and shall take all measures necessary to ensure that they are implemented. Such penalties shall be effective, proportionate and dissuasive. 2. Each Member State shall notify to the Commission the provisions of its law which it adopts pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them. CHAPTER IX Provisions relating to specific processing situations Article 85 Processing and freedom of expression and information 1. Member States shall by law reconcile the right to the protection of personal data pursuant to this Regulation with the right to freedom of expression and information, including processing for journalistic purposes and the purposes of academic, artistic or literary expression. 2. For processing carried out for journalistic purposes or the purpose of academic artistic or literary expression, Member States shall provide for exemptions or derogations from Chapter II (principles), Chapter III (rights of the data subject), Chapter IV (controller and processor), Chapter V (transfer of personal data to third countries or international organisations), Chapter VI (independent supervisory authorities), Chapter VII (cooperation and consistency) and Chapter IX (specific data processing situations) if they are necessary to reconcile the right to the protection of personal data with the freedom of expression and information. 3. Each Member State shall notify to the Commission the provisions of its law which it has adopted pursuant to paragraph 2 and, without delay, any subsequent amendment law or amendment affecting them. Article 86 Processing and public access to official documents Personal data in official documents held by a public authority or a public body or a private body for the performance of a task carried out in the public interest may be disclosed by the authority or body in accordance with Union or Member State law to which the public authority or body is subject in order to reconcile public access to official documents with the right to the protection of personal data pursuant to this Regulation. Article 87 Processing of the national identification number Member States may further determine the specific conditions for the processing of a national identification number or any other identifier of general application. In that case the national identification number or any other identifier of general application shall be used only under appropriate safeguards for the rights and freedoms of the data subject pursuant to this Regulation. Article 88 Processing in the context of employment 1. Member States may, by law or by collective agreements, provide for more specific rules to ensure the protection of the rights and freedoms in respect of the processing of employees' personal data in the employment context, in particular for the purposes of the recruitment, the performance of the contract of employment, including discharge of obligations laid down by law or by collective agreements, management, planning and organisation of work, equality and diversity in the workplace, health and safety at work, protection of employer's or customer's property and for the purposes of the exercise and enjoyment, on an individual or collective basis, of rights and benefits related to employment, and for the purpose of the termination of the employment relationship. 2. Those rules shall include suitable and specific measures to safeguard the data subject's human dignity, legitimate interests and fundamental rights, with particular regard to the transparency of processing, the transfer of personal data within a group of undertakings, or a group of enterprises engaged in a joint economic activity and monitoring systems at the work place. 3. Each Member State shall notify to the Commission those provisions of its law which it adopts pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them. Article 89 Safeguards and derogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes 1. Processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, shall be subject to appropriate safeguards, in accordance with this Regulation, for the rights and freedoms of the data subject. Those safeguards shall ensure that technical and organisational measures are in place in particular in order to ensure respect for the principle of data minimisation. Those measures may include pseudonymisation provided that those purposes can be fulfilled in that manner. Where those purposes can be fulfilled by further processing which does not permit or no longer permits the identification of data subjects, those purposes shall be fulfilled in that manner. 2. Where personal data are processed for scientific or historical research purposes or statistical purposes, Union or Member State law may provide for derogations from the rights referred to in Articles 15, 16, 18 and 21 subject to the conditions and safeguards referred to in paragraph 1 of this Article in so far as such rights are likely to render impossible or seriously impair the achievement of the specific purposes, and such derogations are necessary for the fulfilment of those purposes. 3. Where personal data are processed for archiving purposes in the public interest, Union or Member State law may provide for derogations from the rights referred to in Articles 15, 16, 18, 19, 20 and 21 subject to the conditions and safeguards referred to in paragraph 1 of this Article in so far as such rights are likely to render impossible or seriously impair the achievement of the specific purposes, and such derogations are necessary for the fulfilment of those purposes. 4. Where processing referred to in paragraphs 2 and 3 serves at the same time another purpose, the derogations shall apply only to processing for the purposes referred to in those paragraphs. Article 90 Obligations of secrecy 1. Member States may adopt specific rules to set out the powers of the supervisory authorities laid down in points (e) and (f) of Article 58(1) in relation to controllers or processors that are subject, under Union or Member State law or rules established by national competent bodies, to an obligation of professional secrecy or other equivalent obligations of secrecy where this is necessary and proportionate to reconcile the right of the protection of personal data with the obligation of secrecy. Those rules shall apply only with regard to personal data which the controller or processor has received as a result of or has obtained in an activity covered by that obligation of secrecy. 2. Each Member State shall notify to the Commission the rules adopted pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them. Article 91 Existing data protection rules of churches and religious associations 1. Where in a Member State, churches and religious associations or communities apply, at the time of entry into force of this Regulation, comprehensive rules relating to the protection of natural persons with regard to processing, such rules may continue to apply, provided that they are brought into line with this Regulation. 2. Churches and religious associations which apply comprehensive rules in accordance with paragraph 1 of this Article shall be subject to the supervision of an independent supervisory authority, which may be specific, provided that it fulfils the conditions laid down in Chapter VI of this Regulation. CHAPTER X Delegated acts and implementing acts Article 92 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 12(8) and Article 43(8) shall be conferred on the Commission for an indeterminate period of time from 24 May 2016. 3. The delegation of power referred to in Article 12(8) and Article 43(8) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 12(8) and Article 43(8) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 93 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. CHAPTER XI Final provisions Article 94 Repeal of Directive 95/46/EC 1. Directive 95/46/EC is repealed with effect from 25 May 2018. 2. References to the repealed Directive shall be construed as references to this Regulation. References to the Working Party on the Protection of Individuals with regard to the Processing of Personal Data established by Article 29 of Directive 95/46/EC shall be construed as references to the European Data Protection Board established by this Regulation. Article 95 Relationship with Directive 2002/58/EC This Regulation shall not impose additional obligations on natural or legal persons in relation to processing in connection with the provision of publicly available electronic communications services in public communication networks in the Union in relation to matters for which they are subject to specific obligations with the same objective set out in Directive 2002/58/EC. Article 96 Relationship with previously concluded Agreements International agreements involving the transfer of personal data to third countries or international organisations which were concluded by Member States prior to 24 May 2016, and which comply with Union law as applicable prior to that date, shall remain in force until amended, replaced or revoked. Article 97 Commission reports 1. By 25 May 2020 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The reports shall be made public. 2. In the context of the evaluations and reviews referred to in paragraph 1, the Commission shall examine, in particular, the application and functioning of: (a) Chapter V on the transfer of personal data to third countries or international organisations with particular regard to decisions adopted pursuant to Article 45(3) of this Regulation and decisions adopted on the basis of Article 25(6) of Directive 95/46/EC; (b) Chapter VII on cooperation and consistency. 3. For the purpose of paragraph 1, the Commission may request information from Member States and supervisory authorities. 4. In carrying out the evaluations and reviews referred to in paragraphs 1 and 2, the Commission shall take into account the positions and findings of the European Parliament, of the Council, and of other relevant bodies or sources. 5. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account of developments in information technology and in the light of the state of progress in the information society. Article 98 Review of other Union legal acts on data protection The Commission shall, if appropriate, submit legislative proposals with a view to amending other Union legal acts on the protection of personal data, in order to ensure uniform and consistent protection of natural persons with regard to processing. This shall in particular concern the rules relating to the protection of natural persons with regard to processing by Union institutions, bodies, offices and agencies and on the free movement of such data. Article 99 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 25 May 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 April 2016. For the European Parliament The President M. SCHULZ For the Council The President J.A. HENNIS-PLASSCHAERT (1) OJ C 229, 31.7.2012, p. 90. (2) OJ C 391, 18.12.2012, p. 127. (3) Position of the European Parliament of 12 March 2014 (not yet published in the Official Journal) and position of the Council at first reading of 8 April 2016 (not yet published in the Official Journal). Position of the European Parliament of 14 April 2016. (4) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (5) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (C(2003) 1422) (OJ L 124, 20.5.2003, p. 36). (6) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (7) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and the free movement of such data and repealing Council Framework Decision 2008/977/JHA (see page 89 of this Official Journal). (8) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (\u2018Directive on electronic commerce\u2019) (OJ L 178, 17.7.2000, p. 1). (9) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). (10) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29). (11) Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (OJ L 354, 31.12.2008, p. 70). (12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (13) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (14) Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (OJ L 345, 31.12.2003, p. 90). (15) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). (16) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (17) OJ C 192, 30.6.2012, p. 7. (18) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (19) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (20) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (21) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).", "summary": "General data protection regulation (GDPR) General data protection regulation (GDPR) SUMMARY OF: Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and the free movement of such data WHAT IS THE AIM OF THE REGULATION? The general data protection regulation (GDPR) protects individuals when their data is being processed by the private sector and most of the public sector. The processing of data by the relevant authorities for law-enforcement purposes is subject to the data protection law enforcement directive (LED) instead (see summary). It allows individuals to better control their personal data. It also modernises and unifies rules, allowing businesses to reduce red tape and to benefit from greater consumer trust. It establishes a system of completely independent supervisory authorities in charge of monitoring and enforcing compliance. It is part of the European Union (EU) data protection reform, along with the data protection law enforcement directive and Regulation (EU) 2018/1725 on the protection of natural persons with regard to the processing of personal data by the EU institutions, bodies, offices and agencies (see summary). KEY POINTS Individuals\u2019 rights The GDPR strengthens existing rights, provides for new rights and gives individuals more control over their personal data. It includes the following. Easier access to an individual's own data. This includes providing more information on how that data is processed and ensuring that that information is available in a clear and understandable way. A new right to data portability. This makes it easier to transmit personal data between service providers. A clearer right to erasure (right to be forgotten). When an individual no longer wants their data to be processed and there is no legitimate reason to keep it, the data will be deleted. The right to know when their personal data has been breached. Companies and organisations have to notify the relevant data protection supervisory authority and, in cases of serious data breaches, also the individuals affected. Rules for businesses The GDPR creates a level playing field for all companies operating in the EU internal market, adopts a technology-neutral approach and stimulates innovation through a number of steps, which include the following. A single set of EU-wide rules. A single EU-wide law for data protection increases legal certainty and reduces administrative burden. A data protection officer. A person responsible for data protection has to be designated by public authorities and by businesses that process data on a large scale, or whose core activity is the processing of special categories of data, such as health-related data. One-stop shop. Businesses only have to deal with one single supervisory authority (in the EU Member State in which they have their main establishment); the relevant supervisory authorities cooperate in the framework of the European Data Protection Board for cross-border cases. EU rules for non-EU companies. Companies based outside the EU must apply the same rules when offering services or goods to, or when monitoring the behaviours of, individuals within the EU. Innovation-friendly rules. A guarantee that data protection safeguards are built into products and services from the earliest stage of development (data protection by design and by default). Privacy-friendly techniques. Pseudonymisation (when identifying fields within a data record are replaced by one or more artificial identifiers) and encryption (when data is coded in such a way that only authorised parties can read it), for example, are encouraged, in order to limit the intrusiveness of processing. Removal of notifications. The GDPR scrapped most notification obligations and the costs associated with these. One of its aims is to remove obstacles that affect the free flow of personal data within the EU. This will make it easier for businesses to expand in the single digital market. Data protection impact assessments. Organisations will have to carry out impact assessments when data processing may result in a high risk for the rights and freedoms of individuals. Record keeping. Small and medium-sized enterprises are not required to keep records of processing activities \u2013 unless the processing is regular or likely to result in a risk to the rights and freedoms of the person whose data is being processed, or includes sensitive categories of data. A modern toolbox for international data transfers. The GDPR offers various instruments to transfer data outside the EU, including adequacy decisions adopted by the European Commission where the non-EU country offers an adequate level of protection, pre-approved (standard) contractual clauses, binding corporate rules, codes of conduct and certification. Review The Commission submitted a report on the evaluation and review of the regulation in June 2020. The next evaluation is due in 2024. FROM WHEN DOES THE REGULATION APPLY? The GDPR has applied since 25 May 2018. BACKGROUND For further information, see: Reform of EU data protection rules (European Commission) EU data protection rules (European Commission) Commission report: EU data protection rules empower citizens and are fit for the digital age \u2013 press release (European Commission) Data protection reform \u2013 press release (European Commission) Protection of personal data (European Commission). Following the COVID-19 outbreak and the introduction of measures to cope with the impact of the crisis, the Commission adopted: Commission Recommendation (EU) 2020/518 of 8 April 2020 on a common Union toolbox for the use of technology and data to combat and exit from the COVID-19 crisis, in particular concerning mobile applications and the use of anonymised mobility data. MAIN DOCUMENT Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1\u201388). Successive amendments to Regulation (EU) 2016/679 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, pp. 89\u2013131). See consolidated version. Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, pp. 39\u201398). Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, pp. 37\u201347). See consolidated version. last update 07.01.2022"}
{"article": "24.5.2016 EN Official Journal of the European Union L 135/11 REGULATION (EU) 2016/792 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 May 2016 on harmonised indices of consumer prices and the house price index, and repealing Council Regulation (EC) No 2494/95 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 338(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The harmonised index of consumer prices (HICP) is designed to measure inflation in a harmonised manner across Member States. The Commission and the European Central Bank (ECB) use the HICP in their assessment of price stability in the Member States under Article 140 of the Treaty on the Functioning of the European Union (TFEU). (2) Harmonised indices are used in the context of the Commission's macroeconomic imbalance procedure, as established by Regulation (EU) No 1176/2011 of the European Parliament and of the Council (3). (3) Price statistics of high quality and comparability are essential for those responsible for public policy in the Union, researchers and all European citizens. (4) The European System of Central Banks (ESCB) uses the HICP as an index in order to measure the achievement of the ESCB's price stability objective under Article 127(1) TFEU, which is of particular relevance for the definition and implementation of the monetary policy of the Union under Article 127(2) TFEU. Pursuant to Articles 127(4) and 282(5) TFEU, the ECB is to be consulted on any proposed Union act in its fields of competence. (5) The objective of this Regulation is to establish a common framework for the development, production and dissemination of harmonised indices of consumer prices and of the house price index (HPI) at Union and national level. This does not preclude, however, the possibility of extending the application of the framework, in the future, if necessary, to the subnational level. (6) Council Regulation (EC) No 2494/95 (4) established a common framework for setting up harmonised indices of consumer prices. That legal framework needs to be adapted to current requirements and technical progress, thereby further improving the relevance and comparability of harmonised indices of consumer prices and the HPI. On the basis of the new framework established by this Regulation, work on a set of supplementary indicators on price evolution should be initiated. (7) This Regulation takes into account the Commission's better regulation agenda and, in particular, the Commission communication of 8 October 2010 entitled Smart regulation in the European Union. In the statistical field, the Commission has set as a priority the simplification and improvement of the regulatory environment in statistics, as referred to in the Commission communication of 10 August 2009 on the production method of EU statistics: a vision for the next decade. (8) The HICP and the harmonised index of consumer prices at constant tax rates (HICP-CT) should be broken down into categories of the European classification of individual consumption according to purpose (ECOICOP). Such classification should ensure that all European statistics relating to private consumption are consistent and comparable. The ECOICOP should also be consistent with the UN COICOP, which is the international standard classifying individual consumption according to purpose, therefore the ECOICOP should be adapted to align it with changes to the UN COICOP. (9) The HICP is based on observed prices, which include taxes on products. Hence, inflation is affected by changes to tax rates on products. For inflation analysis and for convergence assessment in Member States, information also needs to be collected on the impact of tax changes on inflation. To this end, the HICP should additionally be calculated on the basis of constant tax rate prices. (10) Establishing price indices for dwellings, and in particular for owner-occupied housing (OOH), is an important step towards further improving the relevance and comparability of the HICP. The HPI is a necessary basis for compiling the OOH price index. In addition, the HPI is an important indicator in its own right. By 31 December 2018, the Commission should prepare a report addressing the suitability of the OOH price index for integration into the HICP coverage. Depending on the results of that report, the Commission should, where appropriate, submit, within a reasonable time frame, a proposal for amending this Regulation with regard to integrating the OOH price index into the HICP coverage. (11) Early provisional information on the monthly HICP in the form of a flash estimate is crucial for monetary policy in the euro area. Therefore, such flash estimates should be provided by the Member States whose currency is the euro. (12) The HICP is designed to assess price stability. It is not intended to be a cost of living index. In addition to the HICP, research on a harmonised cost of living index should be initiated. (13) The reference period of the harmonised indices should be updated periodically. Rules for common index reference periods of the harmonised indices and their sub-indices integrated at different points in time should be established in order to ensure that the resulting indices are comparable and relevant. (14) In order to enhance the gradual harmonisation of harmonised indices of consumer prices and the HPI, pilot studies should be launched to assess the feasibility of using improved basic information or applying new methodological approaches. The Commission should take the necessary actions and find the right incentives, including financial support, to encourage such pilot studies. (15) The Commission (Eurostat) should verify the sources and methods used by Member States to calculate harmonised indices and should monitor the implementation of the legal framework by Member States. For that purpose, the Commission (Eurostat) should maintain a regular dialogue with the Member States' statistical authorities. (16) Background information is essential for assessing whether the detailed harmonised indices provided by the Member States are sufficiently comparable. In addition, transparent compilation methods and practices used in Member States help all stakeholders to understand the harmonised indices and further improve their quality. A set of rules for reporting harmonised metadata should therefore be established. (17) In order to ensure the quality of statistical data provided by Member States, the Commission should use the appropriate prerogatives and powers provided for in Article 12 of Regulation (EC) No 223/2009 of the European Parliament and of the Council (5). (18) In order to ensure adaptation to changes to the UN COICOP, to amend the list of items regulated by implementing acts by adding items in order to take account of technical developments in the statistical methods and based on the evaluation of pilot studies, and to modify the list of sub-indices of ECOICOP that Member States are not required to produce in order to include games of chance in the HICP and the HICP-CT, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (19) In order to ensure full comparability of the harmonised indices, uniform conditions are needed for the application of the ECOICOP for the purpose of the HICP and the HICP-CT; for the breakdown of the flash estimate of the HICP provided by Member States whose currency is the euro; for the breakdowns of the OOH price index and of the HPI; for the quality of weights of the harmonised indices; for improved methods based on voluntary pilot studies; for the appropriate methodology; for detailed rules on the rescaling of the harmonised indices; for the data and metadata exchange standards; for the revision of the harmonised indices and their sub-indices; and for technical quality assurance requirements regarding the content of annual standard quality reports, the deadline for providing the reports to the Commission (Eurostat) and the structure of the inventories and the deadline for providing the inventories to the Commission (Eurostat). In order to ensure such uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). (20) In adopting implementing measures and delegated acts in accordance with this Regulation, the Commission should consider, where appropriate, cost-effectiveness and ensure that those measures and acts do not impose a significant additional burden on Member States or respondents. (21) Since the objective of this Regulation, namely the creation of common statistical standards for harmonised indices of consumer prices and the HPI, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (22) In the context of Article 7 of Regulation (EC) No 223/2009, the European Statistical System Committee has been asked to provide its professional guidance. (23) Regulation (EC) No 2494/95 should therefore be repealed, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation lays down a common framework for the development, production and dissemination of harmonised indices of consumer prices (HICP, HICP-CT, OOH price index) and of the house price index (HPI) at Union and national level. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018products\u2019 means goods and services as defined in paragraph 3.01 of Annex A to Regulation (EU) No 549/2013 of the European Parliament and of the Council (7) (\u2018ESA 2010\u2019); (2) \u2018consumer prices\u2019 means the purchase prices paid by households to purchase individual products by means of monetary transactions; (3) \u2018house prices\u2019 means the transaction prices of dwellings purchased by households; (4) \u2018purchase prices\u2019 means the prices actually paid by purchasers for products, including any taxes less subsidies on the products, after the deduction of discounts from standard prices or charges, excluding interest or services charges added under credit arrangements and any extra charges incurred as a result of failing to pay within the period specified at the time of purchase; (5) \u2018administered prices\u2019 means prices that are either directly set or influenced to a significant extent by the government; (6) \u2018harmonised index of consumer prices\u2019 or \u2018HICP\u2019 means the comparable index of consumer prices produced by each Member State; (7) \u2018harmonised index of consumer prices at constant tax rates\u2019 or \u2018HICP-CT\u2019 means the index that measures changes in consumer prices without the impact of changes in tax rates on products over the same period of time; (8) \u2018tax rate\u2019 means a tax parameter and may be a certain percentage of the price or an absolute tax amount levied on a physical unit; (9) \u2018owner-occupied housing price index\u2019 or \u2018OOH price index\u2019 means the index that measures changes in the transaction prices of dwellings new to the household sector and of other products that the households acquire in their role as owner-occupiers; (10) \u2018house price index\u2019 or \u2018HPI\u2019 means the index that measures changes in the transaction prices of dwellings purchased by households; (11) \u2018sub-index of the HICP or the HICP-CT\u2019 means the price index for any category of the European classification of individual consumption according to purpose (ECOICOP) as set out in Annex I; (12) \u2018harmonised indices\u2019 means the HICP, the HICP-CT, the OOH price index and the HPI; (13) \u2018flash estimate of the HICP\u2019 means an early estimate of the HICP provided by Member States whose currency is the euro that may be based on provisional information and, if necessary, appropriate modelling; (14) \u2018Laspeyres-type index\u2019 means the price index that measures the average change in prices from the price reference period to a comparison period using expenditure shares from a period prior to the price reference period, and where the expenditure shares are adjusted to reflect the prices of the price reference period. A \u2018Laspeyres-type index\u2019 is defined as: The price of a product is denoted by p, the price reference period is denoted by 0, and the comparison period is denoted by t. Weights (w) are expenditure shares of a period (b) prior to the price reference period, and are adjusted to reflect the prices of the price reference period 0; (15) \u2018index reference period\u2019 means the period for which the index is set to 100 index points; (16) \u2018price reference period\u2019 means the period to which the price of the comparison period is compared; for monthly indices, the price reference period is December of the previous year, and for quarterly indices, the price reference period is the fourth quarter of the previous year; (17) \u2018basic information\u2019 means data covering: (a) with reference to the HICP and the HICP-CT: (i) purchase prices of products which need to be taken into account in order to compute sub-indices in accordance with this Regulation; (ii) characteristics that determine the product price; (iii) information on taxes and excise duties levied; (iv) information as to whether a price is fully or partially administered; and (v) weights reflecting the level and structure of the consumption of the products concerned; (b) with reference to the OOH price index: (i) transaction prices of dwellings new to the household sector and of other products that the households acquire in their role as owner-occupiers which need to be taken into account to compute the OOH price index in accordance with this Regulation; (ii) characteristics which determine the dwelling price and the prices of other products that the households acquire in their role as owner-occupiers; and (iii) weights reflecting the level and structure of the relevant housing expenditure categories; (c) with reference to the HPI: (i) transaction prices of dwellings purchased by households which need to be taken into account to compute the HPI in accordance with this Regulation; (ii) characteristics which determine the dwelling price; and (iii) weights reflecting the level and structure of the relevant housing expenditure categories; (18) \u2018household\u2019 means a household as referred to in points (a) and (b) of paragraph 2.119 of Annex A to ESA 2010, irrespective of nationality or residence status; (19) \u2018economic territory of the Member State\u2019 means the economic territory as referred to in paragraph 2.05 of Annex A to ESA 2010, with the exception that the extraterritorial enclaves situated within the boundaries of the Member State are included and the territorial enclaves situated in the rest of the world are excluded; (20) \u2018household final monetary consumption expenditure\u2019 means that part of final consumption expenditure incurred: \u2014 by households, \u2014 in monetary transactions, \u2014 on the economic territory of the Member State, \u2014 on products that are used for the direct satisfaction of individual needs or wants, as defined in paragraph 3.101 of Annex A to ESA 2010, \u2014 in one or both of the time periods being compared; (21) \u2018significant change in the production method\u2019 means a change that is estimated to affect the annual rate of change of a given harmonised index or part thereof in any period by more than: (a) 0,1 percentage points for the all-items HICP, HICP-CT, OOH price index or HPI; (b) 0,3, 0,4, 0,5 or 0,6 percentage points for any ECOICOP division, group, class or subclass (5-digit), respectively, for the HICP or the HICP-CT. Article 3 Compilation of the harmonised indices 1. Member States shall provide the Commission (Eurostat) with the harmonised indices as defined in point (12) of Article 2. 2. The harmonised indices shall be annually chain-linked Laspeyres-type indices. 3. The HICP and the HICP-CT shall be based on the price changes and weights of products included in the household final monetary consumption expenditure. 4. Neither the HICP nor the HICP-CT shall cover transactions between households, except in the case of rentals paid by tenants to private landlords, where the latter act as market producers of services purchased by households (tenants). 5. The OOH price index shall be compiled, where possible and provided that the data are available, for the 10 years preceding the entry into force of this Regulation. 6. Sub-indices of the HICP and of the HICP-CT shall be compiled for the categories of ECOICOP. The Commission shall adopt implementing acts specifying uniform conditions for the application of the ECOICOP for the purpose of the HICP and the HICP-CT. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). 7. By 31 December 2018, the Commission shall prepare a report which shall address the suitability of the OOH price index for integration into the HICP coverage. Depending on the results of the report, the Commission shall, where appropriate, submit, within a reasonable timeframe, a proposal for amending this Regulation with regard to integrating the OOH price index into the HICP coverage. If the report establishes that further methodological developments are required for the integration of the OOH price index into the HICP coverage, the Commission shall pursue the methodological work and report to the European Parliament and to the Council on that work, as appropriate. 8. The Commission shall adopt implementing acts specifying the breakdown of the flash estimate of the HICP provided by Member States whose currency is the euro. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). 9. The Commission shall adopt implementing acts specifying the breakdowns of the OOH price index and of the HPI. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). 10. Each year, Member States shall update sub-index weights for the harmonised indices. The Commission shall adopt implementing acts specifying uniform conditions for the quality of weights of the harmonised indices. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 4 Comparability of the harmonised indices 1. For the harmonised indices to be considered comparable, any differences across Member States at all levels of detail shall only reflect differences in price changes or expenditure patterns. 2. Any sub-indices of the harmonised indices that deviate from the concepts or methods of this Regulation shall be deemed comparable if they result in an index that is estimated to differ systematically by: (a) less than or equal to 0,1 percentage points on average over one year against the previous year from an index compiled following the methodological approach of this Regulation, in the case of the HICP and the HICP-CT; (b) less than or equal to one percentage point on average over one year against the previous year from an index compiled following the methodological approach of this Regulation, in the case of the OOH price index and the HPI. Where the calculations referred to in the first subparagraph are not possible, Member States shall set out in detail the consequences of using a methodology which deviates from the concepts or methods of this Regulation. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 10 for the amendment of Annex I, in order to ensure comparability of the harmonised indices at international level in accordance with changes to the UN COICOP. 4. In order to ensure uniform conditions in producing comparable harmonised indices, and for the purposes of achieving the objectives of this Regulation, the Commission shall adopt implementing acts further specifying improved methods based on voluntary pilot studies as referred to in Article 8, and the methodology. Those implementing acts shall concern: (i) sampling and representativity; (ii) collection and treatment of prices; (iii) replacements and quality adjustment; (iv) index compilation; (v) revisions; (vi) special indices; (vii) treatment of products in specific areas. The Commission shall ensure that those implementing acts do not impose a significant additional burden on the Member States or on the respondents. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). 5. With a view to the production of the harmonised indices, in order to take account of technical developments in the statistical methods and based on the evaluation of the pilot studies referred to in Article 8(4), the Commission shall be empowered to amend, by means of delegated acts adopted in accordance with Article 10, the first subparagraph of paragraph 4 of this Article by adding items to the list set out therein, provided that such added items do not overlap with existing ones and do not change the scope or nature of harmonised indices as set out in this Regulation. Article 5 Data requirements 1. Basic information collected by Member States for the harmonised indices and their sub-indices shall be representative at Member State level. 2. The information shall be obtained from statistical units as defined in Council Regulation (EEC) No 696/93 (8) or from other sources, provided that the comparability requirements for the harmonised indices referred to in Article 4 of this Regulation are met. 3. The statistical units that provide information on products included in the household final monetary consumption expenditure shall cooperate in the collection or provision of basic information, as required. The statistical units shall give accurate and complete basic information to the national bodies responsible for compiling the harmonised indices. 4. Upon the request of the national bodies responsible for compiling the harmonised indices, the statistical units shall provide, where available, electronic records of transactions, such as scanner data, and at the level of detail necessary in order to produce harmonised indices and to evaluate compliance with the comparability requirements and the quality of the harmonised indices. 5. The common index reference period for the harmonised indices shall be 2015. That index reference period shall be used for the full time series of all harmonised indices and their sub-indices. 6. The harmonised indices and their sub-indices shall be rescaled to a new common index reference period in the case of a major methodological change of the harmonised indices which is adopted in accordance with this Regulation, or every 10 years after the last rescaling starting from 2015. The rescaling to the new index reference period shall take effect: (a) for monthly indices, with the index for January of the following year after the index reference period; (b) for quarterly indices, with the index for the first quarter of the following year after the index reference period. The Commission shall adopt implementing acts establishing detailed rules on the rescaling of the harmonised indices. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). 7. Member States shall not be required to produce and transmit: (a) sub-indices of the HICP and of the HICP-CT accounting for less than one part in a thousand of the total expenditure; (b) sub-indices of the OOH price index and of the HPI accounting for less than one part in a hundred of the total owner-occupier housing expenditure and total purchases of dwellings, respectively. 8. Member States shall not be required to produce the following sub-indices of ECOICOP, either because they are not included in the household final monetary consumption expenditure or because the degree of methodological harmonisation is not yet sufficient: 02.3 Narcotics; 09.4.3 Games of chance; 12.2 Prostitution; 12.5.1 Life insurance; 12.6.1 FISIM. The Commission shall be empowered to adopt delegated acts in accordance with Article 10 to modify the list set out in this paragraph in order to include games of chance in the HICP and the HICP-CT. Article 6 Frequency 1. Member States shall provide the Commission (Eurostat) with the HICP, the HICP-CT and their respective sub-indices at monthly intervals, including those sub-indices produced at longer intervals. 2. Member States shall provide the Commission (Eurostat) with the OOH price index and the HPI at quarterly intervals. They may be provided at monthly intervals on a voluntary basis. 3. Member States shall not be required to produce sub-indices at monthly or quarterly intervals where less frequent data collection fulfils the comparability requirements of Article 4. Member States shall inform the Commission (Eurostat) of the ECOICOP, the OOH price index and the HPI categories for which they intend to collect data at intervals less frequent than monthly, in the case of ECOICOP categories, and quarterly, in the case of the OOH price index and the HPI categories. 4. Each year, Member States shall provide the Commission (Eurostat) with updated sub-index weights for the harmonised indices. Article 7 Deadlines, exchange standards and revisions 1. Member States shall provide the Commission (Eurostat) with the harmonised indices and all sub-indices by no later than: (a) 15 calendar days, for the February to December indices, and 20 calendar days, for the January indices, after the end of the month for which the indices are calculated; and (b) 85 calendar days after the end of the quarter for which the indices are calculated. 2. Member States shall provide the Commission (Eurostat) with the updated weights by no later than: (a) 13 February each year for the monthly indices; (b) 15 June each year for the quarterly indices. 3. Member States whose currency is the euro shall provide the Commission (Eurostat) with the flash estimate of the HICP no later than the penultimate calendar day of the month to which the flash estimate refers. 4. Member States shall provide the Commission (Eurostat) with the data and metadata required by this Regulation in accordance with data and metadata exchange standards. 5. Harmonised indices and their sub-indices that have already been published may be revised. 6. The Commission shall adopt implementing acts specifying in detail the data and metadata exchange standards referred to in paragraph 4, and the uniform conditions for the revision of harmonised indices and their sub-indices as referred to in paragraph 5. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 8 Pilot studies 1. Whenever improved basic information is required for the compilation of the harmonised indices, or when the need for improved comparability of the harmonised indices is identified in the methods referred to in Article 4(4), the Commission (Eurostat) may launch pilot studies, to be carried out on a voluntary basis by Member States. 2. The general budget of the Union shall, where appropriate, contribute to the financing of such pilot studies. 3. The pilot studies shall assess the feasibility of obtaining improved basic information or adopting new methodological approaches. 4. The results of the pilot studies shall be evaluated by the Commission (Eurostat) in close cooperation with Member States and the main users of the harmonised indices, taking into account the benefits of having improved basic information or new methodological approaches relative to the additional costs of production of harmonised indices. 5. By 31 December 2020 and every five years thereafter, the Commission shall submit a report to the European Parliament and the Council evaluating, if applicable, the main findings of the pilot studies. Article 9 Quality assurance 1. Member States shall ensure the quality of the harmonised indices provided. For the purposes of this Regulation, the standard quality criteria set out in Article 12(1) of Regulation (EC) No 223/2009 shall apply. 2. Member States shall provide the Commission (Eurostat) with: (a) annual standard quality reports covering the quality criteria referred to in Article 12(1) of Regulation (EC) No 223/2009; (b) annually updated inventories containing details of data sources, definitions and methods used; (c) further related information at the level of detail necessary to evaluate compliance with the comparability requirements and the quality of the harmonised indices, if requested by the Commission (Eurostat). 3. If a Member State intends to introduce a significant change in the production methods of the harmonised indices or a part thereof, the Member State shall inform the Commission (Eurostat) thereof at the latest three months before any such change would enter into force. The Member State shall provide the Commission (Eurostat) with a quantification of the impact of the change. 4. The Commission shall adopt implementing acts establishing technical quality assurance requirements regarding the content of the annual standard quality reports, the deadline for providing the reports to the Commission (Eurostat) and the structure of the inventories and the deadline for providing the inventories to the Commission (Eurostat). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 10 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. When exercising the power delegated in Articles 4(3), 4(5) and 5(8), the Commission shall ensure that the delegated acts do not impose a significant additional burden on Member States or on the respondents. In addition, the Commission shall duly justify the actions provided for in those delegated acts, considering, where appropriate, cost-effectiveness, including the burden on respondents and the production costs in accordance with Article 14(3) of Regulation (EC) No 223/2009. The Commission shall follow its usual practice and carry out consultations with experts, including Member States' experts, before adopting those delegated acts. 3. The power to adopt delegated acts referred to in Articles 4(3), 4(5) and 5(8) shall be conferred on the Commission for a period of five years as from 13 June 2016. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period. 4. The delegation of power referred to in Articles 4(3), 4(5) and 5(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 4(3), 4(5) and 5(8) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 11 Committee procedure 1. The Commission shall be assisted by the European Statistical System Committee established by Regulation (EC) No 223/2009. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 12 Repeal 1. Without prejudice to paragraph 2, Member States shall continue to provide the harmonised indices in accordance with Regulation (EC) No 2494/95 up to the transmission of data relating to 2016. 2. Regulation (EC) No 2494/95 is repealed with effect from 1 January 2017. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex II. 3. When first adopting the implementing acts referred to in Articles 3(6), 3(9), 3(10), 4(4), 5(6) and 7(6), the Commission shall, to the extent compatible with this Regulation, incorporate the relevant provisions of Commission Regulation (EC) No 1749/96 (9), Commission Regulation (EC) No 2214/96 (10), Council Regulation (EC) No 1687/98 (11), Commission Regulation (EC) No 2646/98 (12), Commission Regulation (EC) No 1617/1999 (13), Council Regulation (EC) No 2166/1999 (14), Commission Regulation (EC) No 2601/2000 (15), Commission Regulation (EC) No 2602/2000 (16), Commission Regulation (EC) No 1920/2001 (17), Commission Regulation (EC) No 1921/2001 (18), Commission Regulation (EC) No 1708/2005 (19), Council Regulation (EC) No 701/2006 (20), Commission Regulation (EC) No 330/2009 (21), Commission Regulation (EU) No 1114/2010 (22) and Commission Regulation (EU) No 93/2013 (23) adopted on the basis of Regulation (EC) No 2494/95, whilst reducing, to the extent appropriate, the overall number of implementing acts. The Regulations adopted on the basis of Regulation (EC) No 2494/95 shall remain applicable for a transitional period. That transitional period shall end on the date of application of the implementing acts first adopted on the basis of Articles 3(6), 3(9), 3(10), 4(4), 5(6) and 7(6) of this Regulation, which shall be the same date for all of those implementing acts. Article 13 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply for the first time to data relating to January 2017. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 May 2016. For the European Parliament The President M. SCHULZ For the Council The President J.A. HENNIS-PLASSCHAERT (1) OJ C 175, 29.5.2015, p. 2. (2) Position of the European Parliament of 8 March 2016 (not yet published in the Official Journal) and decision of the Council of 21 April 2016. (3) Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances (OJ L 306, 23.11.2011, p. 25). (4) Council Regulation (EC) No 2494/95 of 23 October 1995 concerning harmonised indices of consumer prices (OJ L 257, 27.10.1995, p. 1). (5) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European Statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union (OJ L 174, 26.6.2013, p. 1). (8) Council Regulation (EEC) No 696/93 of 15 March 1993 on the statistical units for the observation and analysis of the production system in the Community (OJ L 76, 30.3.1993, p. 1). (9) Commission Regulation (EC) No 1749/96 of 9 September 1996 on initial implementing measures for Council Regulation (EC) No 2494/95 concerning harmonized indices of consumer prices (OJ L 229, 10.9.1996, p. 3). (10) Commission Regulation (EC) No 2214/96 of 20 November 1996 concerning harmonized indices of consumer prices: transmission and dissemination of sub-indices of the HICP (OJ L 296, 21.11.1996, p. 8). (11) Council Regulation (EC) No 1687/98 of 20 July 1998 amending Commission Regulation (EC) No 1749/96 concerning the coverage of goods and services of the harmonised index of consumer prices (OJ L 214, 31.7.1998, p. 12). (12) Commission Regulation (EC) No 2646/98 of 9 December 1998 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards minimum standards for the treatment of tariffs in the Harmonized Index of Consumer Prices (OJ L 335, 10.12.1998, p. 30). (13) Commission Regulation (EC) No 1617/1999 of 23 July 1999 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 \u2014 as regards minimum standards for the treatment of insurance in the Harmonized Index of Consumer Prices and modifying Commission Regulation (EC) No 2214/96 (OJ L 192, 24.7.1999, p. 9). (14) Council Regulation (EC) No 2166/1999 of 8 October 1999 laying down detailed rules for the implementation of Regulation (EC) No 2494/95 as regards minimum standards for the treatment of products in the health, education and social protection sectors in the Harmonised Index of Consumer Prices (OJ L 266, 14.10.1999, p. 1). (15) Commission Regulation (EC) No 2601/2000 of 17 November 2000 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards the timing of entering purchaser prices into the Harmonised Index of Consumer Prices (OJ L 300, 29.11.2000, p. 14). (16) Commission Regulation (EC) No 2602/2000 of 17 November 2000 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards minimum standards for the treatment of price reductions in the Harmonised Index of Consumer Prices (OJ L 300, 29.11.2000, p. 16). (17) Commission Regulation (EC) No 1920/2001 of 28 September 2001 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards minimum standards for the treatment of service charges proportional to transaction values in the harmonised index of consumer prices and amending Regulation (EC) No 2214/96 (OJ L 261, 29.9.2001, p. 46). (18) Commission Regulation (EC) No 1921/2001 of 28 September 2001 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards minimum standards for revisions of the harmonised index of consumer prices and amending Regulation (EC) No 2602/2000 (OJ L 261, 29.9.2001, p. 49). (19) Commission Regulation (EC) No 1708/2005 of 19 October 2005 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards the common index reference period for the harmonised index of consumer prices, and amending Regulation (EC) No 2214/96 (OJ L 274, 20.10.2005, p. 9). (20) Council Regulation (EC) No 701/2006 of 25 April 2006 laying down detailed rules for the implementation of Regulation (EC) No 2494/95 as regards the temporal coverage of price collection in the harmonised index of consumer prices (OJ L 122, 9.5.2006, p. 3). (21) Commission Regulation (EC) No 330/2009 of 22 April 2009 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards minimum standards for the treatment of seasonal products in the Harmonised Indices of Consumer Prices (HICP) (OJ L 103, 23.4.2009, p. 6). (22) Commission Regulation (EU) No 1114/2010 of 1 December 2010 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards minimum standards for the quality of HICP weightings and repealing Commission Regulation (EC) No 2454/97 (OJ L 316, 2.12.2010, p. 4). (23) Commission Regulation (EU) No 93/2013 of 1 February 2013 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 concerning harmonised indices of consumer prices, as regards establishing owner-occupied housing price indices (OJ L 33, 2.2.2013, p. 14). ANNEX I EUROPEAN CLASSIFICATION OF INDIVIDUAL CONSUMPTION ACCORDING TO PURPOSE (ECOICOP) 01 FOOD AND NON-ALCOHOLIC BEVERAGES 01.1 Food 01.1.1 Bread and cereals 01.1.1.1 Rice 01.1.1.2 Flours and other cereals 01.1.1.3 Bread 01.1.1.4 Other bakery products 01.1.1.5 Pizza and quiche 01.1.1.6 Pasta products and couscous 01.1.1.7 Breakfast cereals 01.1.1.8 Other cereal products 01.1.2 Meat 01.1.2.1 Beef and veal 01.1.2.2 Pork 01.1.2.3 Lamb and goat 01.1.2.4 Poultry 01.1.2.5 Other meats 01.1.2.6 Edible offal 01.1.2.7 Dried, salted or smoked meat 01.1.2.8 Other meat preparations 01.1.3 Fish and seafood 01.1.3.1 Fresh or chilled fish 01.1.3.2 Frozen fish 01.1.3.3 Fresh or chilled seafood 01.1.3.4 Frozen seafood 01.1.3.5 Dried, smoked or salted fish and seafood 01.1.3.6 Other preserved or processed fish and seafood-based preparations 01.1.4 Milk, cheese and eggs 01.1.4.1 Fresh whole milk 01.1.4.2 Fresh low fat milk 01.1.4.3 Preserved milk 01.1.4.4 Yoghurt 01.1.4.5 Cheese and curd 01.1.4.6 Other milk products 01.1.4.7 Eggs 01.1.5 Oils and fats 01.1.5.1 Butter 01.1.5.2 Margarine and other vegetable fats 01.1.5.3 Olive oil 01.1.5.4 Other edible oils 01.1.5.5 Other edible animal fats 01.1.6 Fruit 01.1.6.1 Fresh or chilled fruit 01.1.6.2 Frozen fruit 01.1.6.3 Dried fruit and nuts 01.1.6.4 Preserved fruit and fruit-based products 01.1.7 Vegetables 01.1.7.1 Fresh or chilled vegetables other than potatoes and other tubers 01.1.7.2 Frozen vegetables other than potatoes and other tubers 01.1.7.3 Dried vegetables, other preserved or processed vegetables 01.1.7.4 Potatoes 01.1.7.5 Crisps 01.1.7.6 Other tubers and products of tuber vegetables 01.1.8 Sugar, jam, honey, chocolate and confectionery 01.1.8.1 Sugar 01.1.8.2 Jams, marmalades and honey 01.1.8.3 Chocolate 01.1.8.4 Confectionery products 01.1.8.5 Edible ices and ice cream 01.1.8.6 Artificial sugar substitutes 01.1.9 Food products n.e.c. 01.1.9.1 Sauces, condiments 01.1.9.2 Salt, spices and culinary herbs 01.1.9.3 Baby food 01.1.9.4 Ready-made meals 01.1.9.9 Other food products n.e.c. 01.2 Non-alcoholic beverages 01.2.1 Coffee, tea and cocoa 01.2.1.1 Coffee 01.2.1.2 Tea 01.2.1.3 Cocoa and powdered chocolate 01.2.2 Mineral waters, soft drinks, fruit and vegetable juices 01.2.2.1 Mineral or spring waters 01.2.2.2 Soft drinks 01.2.2.3 Fruit and vegetable juices 02 ALCOHOLIC BEVERAGES, TOBACCO AND NARCOTICS 02.1 Alcoholic beverages 02.1.1 Spirits 02.1.1.1 Spirits and liqueurs 02.1.1.2 Alcoholic soft drinks 02.1.2 Wine 02.1.2.1 Wine from grapes 02.1.2.2 Wine from other fruits 02.1.2.3 Fortified wines 02.1.2.4 Wine-based drinks 02.1.3 Beer 02.1.3.1 Lager beer 02.1.3.2 Other alcoholic beer 02.1.3.3 Low and non-alcoholic beer 02.1.3.4 Beer-based drinks 02.2 Tobacco 02.2.0 Tobacco 02.2.0.1 Cigarettes 02.2.0.2 Cigars 02.2.0.3 Other tobacco products 02.3 Narcotics 02.3.0 Narcotics 02.3.0.0 Narcotics 03 CLOTHING AND FOOTWEAR 03.1 Clothing 03.1.1 Clothing materials 03.1.1.0 Clothing materials 03.1.2 Garments 03.1.2.1 Garments for men 03.1.2.2 Garments for women 03.1.2.3 Garments for infants (0 to 2 years) and children (3 to 13 years) 03.1.3 Other articles of clothing and clothing accessories 03.1.3.1 Other articles of clothing 03.1.3.2 Clothing accessories 03.1.4 Cleaning, repair and hire of clothing 03.1.4.1 Cleaning of clothing 03.1.4.2 Repair and hire of clothing 03.2 Footwear 03.2.1 Shoes and other footwear 03.2.1.1 Footwear for men 03.2.1.2 Footwear for women 03.2.1.3 Footwear for infants and children 03.2.2 Repair and hire of footwear 03.2.2.0 Repair and hire of footwear 04 HOUSING, WATER, ELECTRICITY, GAS AND OTHER FUELS 04.1 Actual rentals for housing 04.1.1 Actual rentals paid by tenants 04.1.1.0 Actual rentals paid by tenants 04.1.2 Other actual rentals 04.1.2.1 Actual rentals paid by tenants for secondary residences 04.1.2.2 Garage rentals and other rentals paid by tenants 04.2 Imputed rentals for housing 04.2.1 Imputed rentals of owner-occupiers 04.2.1.0 Imputed rentals of owner-occupiers 04.2.2 Other imputed rentals 04.2.2.0 Other imputed rentals 04.3 Maintenance and repair of the dwelling 04.3.1 Materials for the maintenance and repair of the dwelling 04.3.1.0 Materials for the maintenance and repair of the dwelling 04.3.2 Services for the maintenance and repair of the dwelling 04.3.2.1 Services of plumbers 04.3.2.2 Services of electricians 04.3.2.3 Maintenance services for heating systems 04.3.2.4 Services of painters 04.3.2.5 Services of carpenters 04.3.2.9 Other services for maintenance and repair of the dwelling 04.4 Water supply and miscellaneous services relating to the dwelling 04.4.1 Water supply 04.4.1.0 Water supply 04.4.2 Refuse collection 04.4.2.0 Refuse collection 04.4.3 Sewage collection 04.4.3.0 Sewage collection 04.4.4 Other services relating to the dwelling n.e.c. 04.4.4.1 Maintenance charges in multi-occupied buildings 04.4.4.2 Security services 04.4.4.9 Other services related to dwelling 04.5 Electricity, gas and other fuels 04.5.1 Electricity 04.5.1.0 Electricity 04.5.2 Gas 04.5.2.1 Natural gas and town gas 04.5.2.2 Liquefied hydrocarbons (butane, propane, etc.) 04.5.3 Liquid fuels 04.5.3.0 Liquid fuels 04.5.4 Solid fuels 04.5.4.1 Coal 04.5.4.9 Other solid fuels 04.5.5 Heat energy 04.5.5.0 Heat energy 05 FURNISHINGS, HOUSEHOLD EQUIPMENT AND ROUTINE HOUSEHOLD MAINTENANCE 05.1 Furniture and furnishings, carpets and other floor coverings 05.1.1 Furniture and furnishings 05.1.1.1 Household furniture 05.1.1.2 Garden furniture 05.1.1.3 Lighting equipment 05.1.1.9 Other furniture and furnishings 05.1.2 Carpets and other floor coverings 05.1.2.1 Carpets and rugs 05.1.2.2 Other floor coverings 05.1.2.3 Services of laying of fitted carpets and floor coverings 05.1.3 Repair of furniture, furnishings and floor coverings 05.1.3.0 Repair of furniture, furnishings and floor coverings 05.2 Household textiles 05.2.0 Household textiles 05.2.0.1 Furnishing fabrics and curtains 05.2.0.2 Bed linen 05.2.0.3 Table linen and bathroom linen 05.2.0.4 Repair of household textiles 05.2.0.9 Other household textiles 05.3 Household appliances 05.3.1 Major household appliances whether electric or not 05.3.1.1 Refrigerators, freezers and fridge-freezers 05.3.1.2 Clothes washing machines, clothes drying machines and dish washing machines 05.3.1.3 Cookers 05.3.1.4 Heaters, air conditioners 05.3.1.5 Cleaning equipment 05.3.1.9 Other major household appliances 05.3.2 Small electric household appliances 05.3.2.1 Food processing appliances 05.3.2.2 Coffee machines, tea makers and similar appliances 05.3.2.3 Irons 05.3.2.4 Toasters and grills 05.3.2.9 Other small electric household appliances 05.3.3 Repair of household appliances 05.3.3.0 Repair of household appliances 05.4 Glassware, tableware and household utensils 05.4.0 Glassware, tableware and household utensils 05.4.0.1 Glassware, crystal-ware, ceramic ware and chinaware 05.4.0.2 Cutlery, flatware and silverware 05.4.0.3 Non-electric kitchen utensils and articles 05.4.0.4 Repair of glassware, tableware and household utensils 05.5 Tools and equipment for house and garden 05.5.1 Major tools and equipment 05.5.1.1 Motorised major tools and equipment 05.5.1.2 Repair, leasing and rental of major tools and equipment 05.5.2 Small tools and miscellaneous accessories 05.5.2.1 Non-motorised small tools 05.5.2.2 Miscellaneous small tool accessories 05.5.2.3 Repair of non-motorised small tools and miscellaneous accessories 05.6 Goods and services for routine household maintenance 05.6.1 Non-durable household goods 05.6.1.1 Cleaning and maintenance products 05.6.1.2 Other non-durable small household articles 05.6.2 Domestic services and household services 05.6.2.1 Domestic services by paid staff 05.6.2.2 Cleaning services 05.6.2.3 Hire of furniture and furnishings 05.6.2.9 Other domestic services and household services 06 HEALTH 06.1 Medical products, appliances and equipment 06.1.1 Pharmaceutical products 06.1.1.0 Pharmaceutical products 06.1.2 Other medical products 06.1.2.1 Pregnancy tests and mechanical contraceptive devices 06.1.2.9 Other medical products n.e.c. 06.1.3 Therapeutic appliances and equipment 06.1.3.1 Corrective eye-glasses and contact lenses 06.1.3.2 Hearing aids 06.1.3.3 Repair of therapeutic appliances and equipment 06.1.3.9 Other therapeutic appliances and equipment 06.2 Out-patient services 06.2.1 Medical services 06.2.1.1 General practice 06.2.1.2 Specialist practice 06.2.2 Dental services 06.2.2.0 Dental services 06.2.3 Paramedical services 06.2.3.1 Services of medical analysis laboratories and X-ray centres 06.2.3.2 Thermal-baths, corrective-gymnastic therapy, ambulance services and hire of therapeutic equipment 06.2.3.9 Other paramedical services 06.3 Hospital services 06.3.0 Hospital services 06.3.0.0 Hospital services 07 TRANSPORT 07.1 Purchase of vehicles 07.1.1 Motor cars 07.1.1.1 New motor cars 07.1.1.2 Second-hand motor cars 07.1.2 Motor cycles 07.1.2.0 Motor cycles 07.1.3 Bicycles 07.1.3.0 Bicycles 07.1.4 Animal drawn vehicles 07.1.4.0 Animal drawn vehicles 07.2 Operation of personal transport equipment 07.2.1 Spare parts and accessories for personal transport equipment 07.2.1.1 Tyres 07.2.1.2 Spare parts for personal transport equipment 07.2.1.3 Accessories for personal transport equipment 07.2.2 Fuels and lubricants for personal transport equipment 07.2.2.1 Diesel 07.2.2.2 Petrol 07.2.2.3 Other fuels for personal transport equipment 07.2.2.4 Lubricants 07.2.3 Maintenance and repair of personal transport equipment 07.2.3.0 Maintenance and repair of personal transport equipment 07.2.4 Other services in respect of personal transport equipment 07.2.4.1 Hire of garages, parking spaces and personal transport equipment 07.2.4.2 Toll facilities and parking meters 07.2.4.3 Driving lessons, tests, licences and road worthiness tests 07.3 Transport services 07.3.1 Passenger transport by railway 07.3.1.1 Passenger transport by train 07.3.1.2 Passenger transport by underground and tram 07.3.2 Passenger transport by road 07.3.2.1 Passenger transport by bus and coach 07.3.2.2 Passenger transport by taxi and hired car with driver 07.3.3 Passenger transport by air 07.3.3.1 Domestic flights 07.3.3.2 International flights 07.3.4 Passenger transport by sea and inland waterway 07.3.4.1 Passenger transport by sea 07.3.4.2 Passenger transport by inland waterway 07.3.5 Combined passenger transport 07.3.5.0 Combined passenger transport 07.3.6 Other purchased transport services 07.3.6.1 Funicular, cable-car and chair-lift transport 07.3.6.2 Removal and storage services 07.3.6.9 Other purchased transport services n.e.c. 08 COMMUNICATION 08.1 Postal services 08.1.0 Postal services 08.1.0.1 Letter handling services 08.1.0.9 Other postal services 08.2 Telephone and telefax equipment 08.2.0 Telephone and telefax equipment 08.2.0.1 Fixed telephone equipment 08.2.0.2 Mobile telephone equipment 08.2.0.3 Other equipment of telephone and telefax equipment 08.2.0.4 Repair of telephone or telefax equipment 08.3 Telephone and telefax services 08.3.0 Telephone and telefax services 08.3.0.1 Wired telephone services 08.3.0.2 Wireless telephone services 08.3.0.3 Internet access provision services 08.3.0.4 Bundled telecommunication services 08.3.0.5 Other information transmission services 09 RECREATION AND CULTURE 09.1 Audiovisual, photographic and information processing equipment 09.1.1 Equipment for the reception, recording and reproduction of sound and picture 09.1.1.1 Equipment for the reception, recording and reproduction of sound 09.1.1.2 Equipment for the reception, recording and reproduction of sound and vision 09.1.1.3 Portable sound and vision devices 09.1.1.9 Other equipment for the reception, recording and reproduction of sound and picture 09.1.2 Photographic and cinematographic equipment and optical instruments 09.1.2.1 Cameras 09.1.2.2 Accessories for photographic and cinematographic equipment 09.1.2.3 Optical instruments 09.1.3 Information processing equipment 09.1.3.1 Personal computers 09.1.3.2 Accessories for information processing equipment 09.1.3.3 Software 09.1.3.4 Calculators and other information processing equipment 09.1.4 Recording media 09.1.4.1 Pre-recorded recording media 09.1.4.2 Unrecorded recording media 09.1.4.9 Other recording media 09.1.5 Repair of audiovisual, photographic and information processing equipment 09.1.5.0 Repair of audiovisual, photographic and information processing equipment 09.2 Other major durables for recreation and culture 09.2.1 Major durables for outdoor recreation 09.2.1.1 Camper vans, caravans and trailers 09.2.1.2 Aeroplanes, microlight aircraft, gliders, hang-gliders and hot-air balloons 09.2.1.3 Boats, outboard motors and fitting out of boats 09.2.1.4 Horses, ponies and accessories 09.2.1.5 Major items for games and sport 09.2.2 Musical instruments and major durables for indoor recreation 09.2.2.1 Musical instruments 09.2.2.2 Major durables for indoor recreation 09.2.3 Maintenance and repair of other major durables for recreation and culture 09.2.3.0 Maintenance and repair of other major durables for recreation and culture 09.3 Other recreational items and equipment, gardens and pets 09.3.1 Games, toys and hobbies 09.3.1.1 Games and hobbies 09.3.1.2 Toys and celebration articles 09.3.2 Equipment for sport, camping and open-air recreation 09.3.2.1 Equipment for sport 09.3.2.2 Equipment for camping and open-air recreation 09.3.2.3 Repair of equipment for sport, camping and open-air recreation 09.3.3 Gardens, plants and flowers 09.3.3.1 Garden products 09.3.3.2 Plants and flowers 09.3.4 Pets and related products 09.3.4.1 Purchase of pets 09.3.4.2 Products for pets 09.3.5 Veterinary and other services for pets 09.3.5.0 Veterinary and other services for pets 09.4 Recreational and cultural services 09.4.1 Recreational and sporting services 09.4.1.1 Recreational and sporting services \u2014 Attendance 09.4.1.2 Recreational and sporting services \u2014 Participation 09.4.2 Cultural services 09.4.2.1 Cinemas, theatres, concerts 09.4.2.2 Museums, libraries, zoological gardens 09.4.2.3 Television and radio licence fees, subscriptions 09.4.2.4 Hire of equipment and accessories for culture 09.4.2.5 Photographic services 09.4.2.9 Other cultural services 09.4.3 Games of chance 09.4.3.0 Games of chance 09.5 Newspapers, books and stationery 09.5.1 Books 09.5.1.1 Fiction books 09.5.1.2 Educational text books 09.5.1.3 Other non-fiction books 09.5.1.4 Binding services and E-book downloads 09.5.2 Newspapers and periodicals 09.5.2.1 Newspapers 09.5.2.2 Magazines and periodicals 09.5.3 Miscellaneous printed matter 09.5.3.0 Miscellaneous printed matter 09.5.4 Stationery and drawing materials 09.5.4.1 Paper products 09.5.4.9 Other stationery and drawing materials 09.6 Package holidays 09.6.0 Package holidays 09.6.0.1 Package domestic holidays 09.6.0.2 Package international holidays 10 EDUCATION 10.1 Pre-primary and primary education 10.1.0 Pre-primary and primary education 10.1.0.1 Pre-primary education (ISCED-97 level 0) 10.1.0.2 Primary education (ISCED-97 level 1) 10.2 Secondary education 10.2.0 Secondary education 10.2.0.0 Secondary education 10.3 Post-secondary non-tertiary education 10.3.0 Post-secondary non-tertiary education 10.3.0.0 Post-secondary non-tertiary education (ISCED-97 level 4) 10.4 Tertiary education 10.4.0 Tertiary education 10.4.0.0 Tertiary education 10.5 Education not definable by level 10.5.0 Education not definable by level 10.5.0.0 Education not definable by level 11 RESTAURANTS AND HOTELS 11.1 Catering services 11.1.1 Restaurants, caf\u00e9s and the like 11.1.1.1 Restaurants, caf\u00e9s and dancing establishments 11.1.1.2 Fast food and take away food services 11.1.2 Canteens 11.1.2.0 Canteens 11.2 Accommodation services 11.2.0 Accommodation services 11.2.0.1 Hotels, motels, inns and similar accommodation services 11.2.0.2 Holiday centres, camping sites, youth hostels and similar accommodation services 11.2.0.3 Accommodation services of other establishments 12 MISCELLANEOUS GOODS AND SERVICES 12.1 Personal care 12.1.1 Hairdressing salons and personal grooming establishments 12.1.1.1 Hairdressing for men and children 12.1.1.2 Hairdressing for women 12.1.1.3 Personal grooming treatments 12.1.2 Electric appliances for personal care 12.1.2.1 Electric appliances for personal care 12.1.2.2 Repair of electric appliances for personal care 12.1.3 Other appliances, articles and products for personal care 12.1.3.1 Non-electrical appliances 12.1.3.2 Articles for personal hygiene and wellness, esoteric products and beauty products 12.2 Prostitution 12.2.0 Prostitution 12.2.0.0 Prostitution 12.3 Personal effects n.e.c. 12.3.1 Jewellery, clocks and watches 12.3.1.1 Jewellery 12.3.1.2 Clocks and watches 12.3.1.3 Repair of jewellery, clocks and watches 12.3.2 Other personal effects 12.3.2.1 Travel goods 12.3.2.2 Articles for babies 12.3.2.3 Repair of other personal effects 12.3.2.9 Other personal effects n.e.c. 12.4 Social protection 12.4.0 Social protection 12.4.0.1 Child care services 12.4.0.2 Retirement homes for elderly persons and residences for disabled persons 12.4.0.3 Services to maintain people in their private homes 12.4.0.4 Counselling 12.5 Insurance 12.5.1 Life insurance 12.5.1.0 Life insurance 12.5.2 Insurance connected with the dwelling 12.5.2.0 Insurance connected with the dwelling 12.5.3 Insurance connected with health 12.5.3.1 Public insurance connected with health 12.5.3.2 Private insurance connected with health 12.5.4 Insurance connected with transport 12.5.4.1 Motor vehicle insurance 12.5.4.2 Travel insurance 12.5.5 Other insurance 12.5.5.0 Other insurance 12.6 Financial services n.e.c. 12.6.1 FISIM 12.6.1.0 FISIM 12.6.2 Other financial services n.e.c. 12.6.2.1 Charges by banks and post offices 12.6.2.2 Fees and service charges of brokers, investment counsellors 12.7 Other services n.e.c. 12.7.0 Other services n.e.c. 12.7.0.1 Administrative fees 12.7.0.2 Legal services and accountancy 12.7.0.3 Funeral services 12.7.0.4 Other fees and services ANNEX II Correlation table Regulation (EC) No 2494/95 This Regulation Article 1 Article 1 Article 2, point (a) Article 2, point (6) Article 2, point (b) \u2014 Article 2, point (c) \u2014 Article 3 Article 3(3) and (10) Article 4 Article 4(1), (2) and (4) Article 5(1)(b) Article 5(5) and (6) Article 5(3) Article 4(4) Article 6 Article 5(1) and (2) Article 7 Article 5(3) Article 8 Article 6(1), (3) and (4) Article 9 Article 3(1), (2) and (6) Article 10 Article 7(1) Article 11 \u2014 Article 12 Article 9(2) Article 13 \u2014 Article 14 Article 11 Article 15 \u2014 Article 16 Article 13", "summary": "Harmonised measurement of inflation across the EU Harmonised measurement of inflation across the EU SUMMARY OF: Regulation (EU) 2016/792 \u2014 harmonised indices of consumer prices and the house price index WHAT IS THE AIM OF THE REGULATION? It lays down a common set of rules for developing, producing and disseminating harmonised national and EU indices of consumer and house prices. KEY POINTS The legislation applies to the following: the harmonised index of consumer prices* (HICP);the harmonised index of consumer prices at constant tax rates (HICP-CT);the harmonised price index for owner-occupied housing (OOH);the harmonised house price index (HPI). EU countries\u2019 national authorities: provide the European Commission\u2019s statistical office, Eurostat, with the harmonised indices;update the product category weightings for the indices every year. Any changes in the prices of dwellings purchased by households or of other products that households buy in their capacity as owner occupiers of dwellings are included in the OOH but excluded from the HICP and HICP-CT. Furthermore, data for the following are not included in the HICP and HICP-CT: narcotics;gambling;prostitution;life insurance;financial intermediation services indirectly measured (FISIM) \u2014 the value of financial intermediation services is provided, but not directly charged for, by financial institutions. The Commission may adopt further measures, provided these do not impose a significant additional burden on national authorities, to ensure the comparable harmonised indices are produced under uniform conditions. These cover: sampling and representativity;collection and treatment of prices;replacements and quality adjustment;index compilation;revisions;special indices;treatment of products* in specific areas. National authorities provide Eurostat with HICP and HICP-CT data every month and with the HPI and OOH data every quarter. The harmonised indices and subindices are adjusted to a new common index reference when a major methodological change takes place, or every 10 years from 2015. The Commission had to prepare a report on the integration of the OOH price index into the HICP coverage by 31 December 2018. The Commission had to prepare a report on the use of delegated powers by 13 September 2020. Implementing act In 2020, the Commission adopted Implementing Regulation (EU) 2020/1148, which lays down the methodological and technical specifications in accordance with Regulation (EU) 2016/792 as regards harmonised indices of consumer prices and the house price index. The regulation: establishes uniform conditions for producing: the HICP and the HICP-CT andthe OOH price index and the HPI; integrates the relevant rules from \u2014 and repeals \u2014 Regulations (EC) No 1749/96, (EC) No 2214/96, (EC) No 1687/98, (EC) No 2646/98, (EC) No 1617/1999, (EC) No 2166/1999, (EC) No 2601/2000, (EC) No 2602/2000, (EC) No 1920/2001, (EC) No 1921/2001, (EC) No 1708/2005, (EC) No 701/2006, (EC) No 330/2009, (EU) No 1114/2010 and (EU) No 93/2013, adopted on the basis of Regulation (EC) No 2494/95 (which Regulation (EU) 2016/792 also replaces and repeals). FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) 2016/792 has applied since 13 June 2016. It was used for the first time for January 2017 data. BACKGROUND The HICP measures inflation rates at national and EU level. The Commission and the European Central Bank use the index to assess price stability in EU countries and in the euro area. High-quality comparable price statistics are essential for those responsible for public policy in the EU, researchers and all EU citizens. For more information, see: Harmonised Indices of Consumer Prices (HICP) Legislation (European Commission) Harmonised index of consumer prices (HICP) (prc_hicp) (European Commission). KEY TERMS Consumer price: the purchase price that households pay, through monetary transactions, to buy individual products. Products: goods and services. MAIN DOCUMENT Regulation (EU) 2016/792 of the European Parliament and of the Council of 11 May 2016 on harmonised indices of consumer prices and the house price index, and repealing Council Regulation (EC) No 2494/95 (OJ L 135, 24.5.2016, pp. 11-38) RELATED DOCUMENTS Commission Implementing Regulation (EU) 2020/1148 of 31 July 2020 laying down the methodological and technical specifications in accordance with Regulation (EU) 2016/792 of the European Parliament and of the Council as regards harmonised indices of consumer prices and the house price index (OJ L 252, 4.8.2020, pp. 12-23) Report from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission under Regulation (EU) 2016/792 on harmonised indices of consumer prices and the house price index (COM(2020) 354 final, 4.8.2020) Report from the Commission to the European Parliament and the Council on the suitability of the owner-occupied housing (OOH) price index for integration into the harmonised index of consumer prices (HICP) coverage (COM(2018) 768 final, 29.11.2018) last update 21.10.2020"}
{"article": "30.6.2016 EN Official Journal of the European Union L 176/21 REGULATION (EU) 2016/1036 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2016 on protection against dumped imports from countries not members of the European Union (codification) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Council Regulation (EC) No 1225/2009 (2) has been substantially amended several times (3). In the interests of clarity and rationality, that Regulation should be codified. (2) The Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 1994 (\u2018the 1994 Anti-Dumping Agreement\u2019) contains detailed rules, relating in particular to the calculation of dumping, procedures for initiating and pursuing an investigation, including the establishment and treatment of the facts, the imposition of provisional measures, the imposition and collection of anti-dumping duties, the duration and review of anti-dumping measures and the public disclosure of information relating to anti-dumping investigations. (3) In order to ensure a proper and transparent application of the rules of the 1994 Anti-Dumping Agreement, the language of that agreement should be reflected in Union legislation to the best extent possible. (4) In applying the rules of the 1994 Anti-Dumping Agreement, it is essential, in order to maintain the balance of rights and obligations which the General Agreement on Tariffs and Trade (\u2018GATT\u2019) established, that the Union take account of the interpretation of those rules by the Union's major trading partners. (5) It is desirable to set out clear and detailed rules on the calculation of the normal value. In particular, such value should in all cases be based on representative sales in the ordinary course of trade in the exporting country. It is expedient to give guidance as to when parties may be considered as being associated for the purpose of determining dumping. It is expedient to define the circumstances in which domestic sales may be considered to be made at a loss and may be disregarded, and in which recourse may be had to remaining sales, or to constructed normal value, or to sales to a third country. It is also appropriate to provide for a proper allocation of costs, even in start-up situations, and for guidance as to the definition of start-up and the extent and method of allocation. It is also necessary, when constructing the normal value, to indicate the methodology to be applied in determining the amounts for selling, general and administrative costs and the profit margin that should be included in such value. (6) When determining the normal value for non-market-economy countries, it appears prudent to set out rules for choosing the appropriate market-economy third country to be used for such purpose and, where it is not possible to find a suitable third country, to provide that the normal value may be established on any other reasonable basis. (7) It is expedient to define the export price and to enumerate the adjustments which should be made in those cases where a reconstruction of that price from the first open-market price is deemed necessary. (8) For the purpose of ensuring a fair comparison between the export price and the normal value, it is advisable to list the factors which may affect prices and price comparability and to set out specific rules as to when and how the adjustments should be made, including the fact that any duplication of adjustments should be avoided. It is also necessary to provide that comparison may be made using average prices although individual export prices may be compared to an average normal value where the former vary by customer, region or time period. (9) It is desirable to set out clear and detailed guidance as to the factors which may be relevant for the determination of whether the dumped imports have caused material injury or are threatening to cause injury. In demonstrating that the volume and price levels of the imports concerned are responsible for injury sustained by the Union industry, attention should be given to the effect of other factors and in particular prevailing market conditions in the Union. (10) It is advisable to define the term \u2018Union industry\u2019 and to provide that parties related to exporters may be excluded from such an industry, and to define the term \u2018related\u2019. It is also necessary to provide for anti-dumping action to be taken on behalf of producers in a region of the Union and to set out guidelines on the definition of such a region. (11) It is necessary to specify who may lodge an anti-dumping complaint, including the extent to which it should be supported by the Union industry, and the information on dumping, injury and causation which such a complaint should contain. It is also expedient to specify the procedures for the rejection of complaints or the initiation of proceedings. (12) It is necessary to specify the manner in which interested parties should be given notice of the information which the authorities require. Interested parties should have ample opportunity to present all relevant evidence and to defend their interests. It is also desirable to set out clearly the rules and procedures to be followed during the investigation, in particular the rules whereby interested parties are to make themselves known, present their views and submit information within specified time limits, if such views and information are to be taken into account. It is also appropriate to set out the conditions under which an interested party may have access to, and comment on, information presented by other interested parties. There should also be cooperation between the Member States and the Commission in the collection of information. (13) It is necessary to set out the conditions under which provisional duties may be imposed, including conditions whereby provisional duties may be imposed no earlier than 60 days from initiation and no later than nine months thereafter. For administrative reasons, it is also necessary to provide that such duties may in all cases be imposed by the Commission, either directly for a nine-month period or in two stages of six and three months. (14) It is necessary to set out procedures for accepting undertakings which eliminate dumping and injury instead of imposing provisional or definitive duties. It is also appropriate to specify the consequences of a breach or withdrawal of undertakings and that provisional duties may be imposed in cases of suspected violation or where further investigation is necessary to supplement the findings. In accepting undertakings, care should be taken that the proposed undertakings, and their enforcement, do not lead to anti-competitive behaviour. (15) It is necessary to provide that the termination of cases should, irrespective of whether definitive measures are adopted or not, normally take place within 12 months, and in no case more than 15 months, of the initiation of the investigation. (16) Investigations or proceedings should be terminated where the dumping is de minimis or the injury is negligible, and it is appropriate to define those situations. Where measures are to be imposed, it is necessary to provide for the termination of investigations and to specify that measures should be less than the margin of dumping if such lesser amount would remove the injury, and also to specify the method of calculating the level of measures in cases of sampling. (17) It is necessary to provide for retroactive collection of provisional duties if that is deemed appropriate and to define the circumstances which may trigger the retroactive application of duties to avoid the undermining of the definitive measures to be applied. It is also necessary to provide that duties may be applied retroactively in cases of breach or withdrawal of undertakings. (18) It is necessary to provide that measures are to lapse after five years unless a review indicates that they should be maintained. It is also necessary to provide, in cases where sufficient evidence is submitted of changed circumstances, for interim reviews or for investigations to determine whether refunds of anti-dumping duties are warranted. It is also appropriate to provide that, in any recalculation of dumping which necessitates a reconstruction of export prices, duties are not to be treated as a cost incurred between importation and resale where those duties are being reflected in the prices of the products subject to measures in the Union. (19) It is necessary to provide specifically for the reassessment of export prices and dumping margins where the duty is being absorbed by the exporter through a form of compensatory arrangement and the measures are not being reflected in the prices of the products subject to measures in the Union. (20) The 1994 Anti-Dumping Agreement does not contain provisions regarding the circumvention of anti-dumping measures, though a separate GATT Ministerial Decision recognised circumvention as a problem and referred it to the GATT Anti-dumping Committee for resolution. Given the failure of the multilateral negotiations so far and pending the outcome of the referral to the World Trade Organisation (\u2018WTO\u2019) Anti-Dumping Committee, Union legislation should contain provisions to deal with practices, including mere assembly of goods in the Union or a third country, which have as their main aim the circumvention of anti-dumping measures. (21) It is also desirable to clarify which practices constitute circumvention of the measures in place. Circumvention practices may take place either inside or outside the Union. It is consequently necessary to provide that exemptions from the extended duties which may be granted to importers may also be granted to exporters when duties are being applied to address circumvention taking place outside the Union. (22) It is expedient to permit the suspension of anti-dumping measures where there is a temporary change in market conditions which makes the continued imposition of such measures temporarily inappropriate. (23) It is necessary to provide that imports under investigation may be made subject to registration upon importation in order to enable measures to be subsequently applied against such imports. (24) In order to ensure the proper enforcement of measures, it is necessary that Member States monitor, and report to the Commission on, the import trade of products subject to investigation or subject to measures, as well as the amount of duties collected under this Regulation. (25) It is expedient to provide for verification visits to check information submitted on dumping and injury, such visits being, however, conditional on proper replies to questionnaires being received. (26) It is essential to provide for sampling in cases where the number of parties or transactions is large in order to permit completion of investigations within the appointed time limits. (27) It is necessary to provide that, where parties do not cooperate satisfactorily, other information may be used to establish findings and that such information may be less favourable to the parties than if they had cooperated. (28) Provision should be made for the treatment of confidential information so that business secrets are not divulged. (29) It is essential that provision be made for proper disclosure of the essential facts and considerations to parties which qualify for such treatment and that such disclosure be made, with due regard to the decision-making process in the Union, within a time limit which permits parties to defend their interests. (30) It is prudent to provide for an administrative system under which arguments can be presented as to whether measures are in the Union's interest, including consumers' interest, and to specify the time limits within which such information has to be presented as well as the disclosure rights of the parties concerned. (31) The implementation of this Regulation requires uniform conditions for the adoption of provisional and definitive duties, and for the termination of an investigation without measures. Those measures should be adopted by the Commission in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (4). (32) The advisory procedure should be used for the adoption of provisional measures given the effects of such measures and their sequential logic in relation to the adoption of definitive measures. It should also be used for the acceptance of undertakings, initiation and non-initiation of expiry reviews, suspension of measures, extension of the suspension of measures and the reinstatement of measures given the effect of such measures as compared to definitive measures. Where a delay in the imposition of measures would cause injury which would be difficult to repair, it is necessary to allow the Commission to adopt immediately applicable provisional measures, HAVE ADOPTED THIS REGULATION: Article 1 Principles 1. An anti-dumping duty may be imposed on any dumped product whose release for free circulation in the Union causes injury. 2. A product is to be considered as being dumped if its export price to the Union is less than a comparable price for a like product, in the ordinary course of trade, as established for the exporting country. 3. The exporting country shall normally be the country of origin. However, it may be an intermediate country, except where, for example, the products are merely transhipped through that country, or the products concerned are not produced in that country, or there is no comparable price for them in that country. 4. For the purposes of this Regulation, \u2018like product\u2019 means a product which is identical, that is to say, alike in all respects, to the product under consideration, or, in the absence of such a product, another product which, although not alike in all respects, has characteristics closely resembling those of the product under consideration. Article 2 Determination of dumping 1. The normal value shall normally be based on the prices paid or payable, in the ordinary course of trade, by independent customers in the exporting country. However, where the exporter in the exporting country does not produce or does not sell the like product, the normal value may be established on the basis of prices of other sellers or producers. Prices between parties which appear to be associated or to have a compensatory arrangement with each other may not be considered to be in the ordinary course of trade and may not be used to establish the normal value unless it is determined that they are unaffected by the relationship. In order to determine whether two parties are associated, account may be taken of the definition of related parties set out in Article 127 of Commission Implementing Regulation (EU) 2015/2447 (5). 2. Sales of the like product intended for domestic consumption shall normally be used to determine the normal value if such sales volume constitutes 5 % or more of the sales volume of the product under consideration to the Union. However, a lower volume of sales may be used when, for example, the prices charged are considered representative for the market concerned. 3. When there are no or insufficient sales of the like product in the ordinary course of trade, or where, because of the particular market situation, such sales do not permit a proper comparison, the normal value of the like product shall be calculated on the basis of the cost of production in the country of origin plus a reasonable amount for selling, general and administrative costs and for profits, or on the basis of the export prices, in the ordinary course of trade, to an appropriate third country, provided that those prices are representative. A particular market situation for the product concerned within the meaning of the first subparagraph may be deemed to exist, inter alia, when prices are artificially low, when there is significant barter trade, or when there are non-commercial processing arrangements. 4. Sales of the like product in the domestic market of the exporting country, or export sales to a third country, at prices below unit production costs (fixed and variable) plus selling, general and administrative costs may be treated as not being in the ordinary course of trade by reason of price, and may be disregarded in determining the normal value, only if it is determined that such sales are made within an extended period in substantial quantities, and are at prices which do not provide for the recovery of all costs within a reasonable period of time. If prices which are below costs at the time of sale are above weighted average costs for the period of investigation, such prices shall be considered to provide for recovery of costs within a reasonable period of time. The extended period of time shall normally be one year but shall in no case be less than six months, and sales below unit cost shall be considered to be made in substantial quantities within such a period when it is established that the weighted average selling price is below the weighted average unit cost, or that the volume of sales below unit cost is not less than 20 % of sales being used to determine normal value. 5. Costs shall normally be calculated on the basis of records kept by the party under investigation, provided that such records are in accordance with the generally accepted accounting principles of the country concerned and that it is shown that the records reasonably reflect the costs associated with the production and sale of the product under consideration. If costs associated with the production and sale of the product under investigation are not reasonably reflected in the records of the party concerned, they shall be adjusted or established on the basis of the costs of other producers or exporters in the same country or, where such information is not available or cannot be used, on any other reasonable basis, including information from other representative markets. Consideration shall be given to evidence submitted on the proper allocation of costs, provided that it is shown that such allocations have been historically utilised. In the absence of a more appropriate method, preference shall be given to the allocation of costs on the basis of turnover. Unless already reflected in the cost allocations under this subparagraph, costs shall be adjusted appropriately for those non-recurring items of cost which benefit future and/or current production. Where the costs for part of the period for cost recovery are affected by the use of new production facilities requiring substantial additional investment and by low-capacity utilisation rates, which are the result of start-up operations which take place within or during part of the investigation period, the average costs for the start-up phase shall be those applicable, under the abovementioned allocation rules, at the end of such a phase, and shall be included at that level, for the period concerned, in the weighted average costs referred to in the second subparagraph of paragraph 4. The length of a start-up phase shall be determined in relation to the circumstances of the producer or exporter concerned, but shall not exceed an appropriate initial portion of the period for cost recovery. For this adjustment to costs applicable during the investigation period, information relating to a start-up phase which extends beyond that period shall be taken into account where it is submitted prior to verification visits and within three months of the initiation of the investigation. 6. The amounts for selling, for general and administrative costs and for profits shall be based on actual data pertaining to production and sales, in the ordinary course of trade, of the like product by the exporter or producer under investigation. When such amounts cannot be determined on that basis, the amounts may be determined on the basis of: (a) the weighted average of the actual amounts determined for other exporters or producers subject to investigation in respect of production and sales of the like product in the domestic market of the country of origin; (b) the actual amounts applicable to production and sales, in the ordinary course of trade, of the same general category of products for the exporter or producer in question in the domestic market of the country of origin; (c) any other reasonable method, provided that the amount for profit so established shall not exceed the profit normally realised by other exporters or producers on sales of products of the same general category in the domestic market of the country of origin. 7. (a) In the case of imports from non-market-economy countries (6), the normal value shall be determined on the basis of the price or constructed value in a market economy third country, or the price from such a third country to other countries, including the Union, or, where those are not possible, on any other reasonable basis, including the price actually paid or payable in the Union for the like product, duly adjusted if necessary to include a reasonable profit margin. An appropriate market-economy third country shall be selected in a not unreasonable manner, due account being taken of any reliable information made available at the time of selection. Account shall also be taken of time limits. Where appropriate, a market-economy third country which is subject to the same investigation shall be used. The parties to the investigation shall be informed shortly after its initiation of the market-economy third country envisaged and shall be given 10 days to comment. (b) In anti-dumping investigations concerning imports from the People's Republic of China, Vietnam and Kazakhstan and any non-market-economy country which is a member of the WTO at the date of the initiation of the investigation, the normal value shall be determined in accordance with paragraphs 1 to 6, if it is shown, on the basis of properly substantiated claims by one or more producers subject to the investigation and in accordance with the criteria and procedures set out in point (c), that market-economy conditions prevail for this producer or producers in respect of the manufacture and sale of the like product concerned. When that is not the case, the rules set out under point (a) shall apply. (c) A claim under point (b) must be made in writing and contain sufficient evidence that the producer operates under market-economy conditions, that is if: \u2014 decisions of firms regarding prices, costs and inputs, including for instance raw materials, cost of technology and labour, output, sales and investment, are made in response to market signals reflecting supply and demand, and without significant State interference in that regard, and costs of major inputs substantially reflect market values, \u2014 firms have one clear set of basic accounting records which are independently audited in line with international accounting standards and are applied for all purposes, \u2014 the production costs and financial situation of firms are not subject to significant distortions carried over from the former non-market-economy system, in particular in relation to depreciation of assets, other write-offs, barter trade and payment via compensation of debts, \u2014 the firms concerned are subject to bankruptcy and property laws which guarantee legal certainty and stability for the operation of firms, and \u2014 exchange rate conversions are carried out at the market rate. A determination whether the producer meets the criteria referred to under this point shall normally be made within seven months of, but in any event not later than eight months after, the initiation of the investigation, after the Union industry has been given an opportunity to comment. That determination shall remain in force throughout the investigation. The Commission shall provide information to the Member States concerning its analysis of claims made pursuant to point (b) normally within 28 weeks of the initiation of the investigation. (d) When the Commission has limited its investigation in accordance with Article 17, a determination pursuant to points (b) and (c) of this paragraph shall be limited to the parties included in the investigation and any producer that receives individual treatment pursuant to Article 17(3). 8. The export price shall be the price actually paid or payable for the product when sold for export from the exporting country to the Union. 9. In cases where there is no export price or where it appears that the export price is unreliable because of an association or a compensatory arrangement between the exporter and the importer or a third party, the export price may be constructed on the basis of the price at which the imported products are first resold to an independent buyer, or, if the products are not resold to an independent buyer or are not resold in the condition in which they were imported, on any reasonable basis. In those cases, adjustment for all costs, including duties and taxes, incurred between the importation and resale, and for profits accruing, shall be made so as to establish a reliable export price, at the Union frontier level. The items for which adjustment shall be made shall include those normally borne by an importer but paid by any party, either inside or outside the Union, which appears to be associated or to have a compensatory arrangement with the importer or exporter, including usual transport, insurance, handling, loading and ancillary costs, customs duties, any anti-dumping duties, and other taxes payable in the importing country by reason of the importation or sale of the goods, and a reasonable margin for selling, general and administrative costs and profit. 10. A fair comparison shall be made between the export price and the normal value. This comparison shall be made at the same level of trade and in respect of sales made at, as closely as possible, the same time and with due account taken of other differences which affect price comparability. Where the normal value and the export price as established are not on such a comparable basis, due allowance, in the form of adjustments, shall be made in each case, on its merits, for differences in factors which are claimed, and demonstrated, to affect prices and price comparability. Any duplication when making adjustments shall be avoided, in particular in relation to discounts, rebates, quantities and level of trade. When the specified conditions are met, the factors for which adjustment can be made are listed as follows: (a) Physical characteristics An adjustment shall be made for differences in the physical characteristics of the product concerned. The amount of the adjustment shall correspond to a reasonable estimate of the market value of the difference. (b) Import charges and indirect taxes An adjustment shall be made to the normal value for an amount corresponding to any import charges or indirect taxes borne by the like product and by materials physically incorporated therein, when intended for consumption in the exporting country and not collected or refunded in respect of the product exported to the Union. (c) Discounts, rebates and quantities An adjustment shall be made for differences in discounts and rebates, including those given for differences in quantities, if those are properly quantified and are directly linked to the sales under consideration. An adjustment may also be made for deferred discounts and rebates if the claim is based on consistent practice in prior periods, including compliance with the conditions required to qualify for the discount or rebates. (d) Level of trade (i) An adjustment for differences in levels of trade, including any differences which may arise in OEM (original equipment manufacturer) sales, shall be made where, in relation to the distribution chain in both markets, it is shown that the export price, including a constructed export price, is at a different level of trade from the normal value and the difference has affected price comparability, which is demonstrated by consistent and distinct differences in functions and prices of the seller for the different levels of trade in the domestic market of the exporting country. The amount of the adjustment shall be based on the market value of the difference. (ii) However, in circumstances not envisaged under point (i), when an existing difference in level of trade cannot be quantified because of the absence of the relevant levels on the domestic market of the exporting countries, or where certain functions are shown clearly to relate to levels of trade other than the one which is to be used in the comparison, a special adjustment may be granted. (e) Transport, insurance, handling, loading and ancillary costs An adjustment shall be made for differences in the directly related costs incurred for conveying the product concerned from the premises of the exporter to an independent buyer, where such costs are included in the prices charged. Those costs shall include transport, insurance, handling, loading and ancillary costs. (f) Packing An adjustment shall be made for differences in the directly related packing costs for the product concerned. (g) Credit An adjustment shall be made for differences in the cost of any credit granted for the sales under consideration, provided that it is a factor taken into account in the determination of the prices charged. (h) After-sales costs An adjustment shall be made for differences in the direct costs of providing warranties, guarantees, technical assistance and services, as provided for by law and/or in the sales contract. (i) Commissions An adjustment shall be made for differences in commissions paid in respect of the sales under consideration. The term \u2018commissions\u2019 shall be understood to include the mark-up received by a trader of the product or the like product if the functions of such a trader are similar to those of an agent working on a commission basis. (j) Currency conversions When the price comparison requires a conversion of currencies, such conversion shall be made using the rate of exchange on the date of sale, except that, when a sale of foreign currency on forward markets is directly linked to the export sale involved, the rate of exchange in the forward sale shall be used. Normally, the date of sale shall be the date of invoice but the date of contract, purchase order or order confirmation may be used if those more appropriately establish the material terms of sale. Fluctuations in exchange rates shall be ignored and exporters shall be granted 60 days to reflect a sustained movement in exchange rates during the investigation period. (k) Other factors An adjustment may also be made for differences in other factors not provided for under points (a) to (j), if it is demonstrated that they affect price comparability as required under this paragraph, in particular if customers consistently pay different prices on the domestic market because of the difference in such factors. 11. Subject to the relevant provisions governing fair comparison, the existence of margins of dumping during the investigation period shall normally be established on the basis of a comparison of a weighted average normal value with a weighted average of prices of all export transactions to the Union, or by a comparison of individual normal values and individual export prices to the Union on a transaction-to-transaction basis. However, a normal value established on a weighted average basis may be compared to prices of all individual export transactions to the Union, if there is a significant difference in the pattern of export prices among different purchasers, regions or time periods, and if the methods specified in the first sentence of this paragraph would not reflect the full degree of dumping being practised. This paragraph shall not preclude the use of sampling in accordance with Article 17. 12. The dumping margin shall be the amount by which the normal value exceeds the export price. Where dumping margins vary, a weighted average dumping margin may be established. Article 3 Determination of injury 1. Pursuant to this Regulation, the term \u2018injury\u2019 shall, unless otherwise specified, be taken to mean material injury to the Union industry, threat of material injury to the Union industry or material retardation of the establishment of such an industry and shall be interpreted in accordance with the provisions of this Article. 2. A determination of injury shall be based on positive evidence and shall involve an objective examination of: (a) the volume of the dumped imports and the effect of the dumped imports on prices in the Union market for like products; and (b) the consequent impact of those imports on the Union industry. 3. With regard to the volume of the dumped imports, consideration shall be given to whether there has been a significant increase in dumped imports, either in absolute terms or relative to production or consumption in the Union. With regard to the effect of the dumped imports on prices, consideration shall be given to whether there has been significant price undercutting by the dumped imports as compared with the price of a like product of the Union industry, or whether the effect of such imports is otherwise to depress prices to a significant degree or prevent price increases, which would otherwise have occurred, to a significant degree. No one or more of those factors can necessarily give decisive guidance. 4. Where imports of a product from more than one country are simultaneously subject to anti-dumping investigations, the effects of such imports shall be cumulatively assessed only if it is determined that: (a) the margin of dumping established in relation to the imports from each country is more than de minimis as defined in Article 9(3) and the volume of imports from each country is not negligible; and (b) a cumulative assessment of the effects of the imports is appropriate in the light of the conditions of competition between imported products and the conditions of competition between the imported products and the like Union product. 5. The examination of the impact of the dumped imports on the Union industry concerned shall include an evaluation of all relevant economic factors and indices having a bearing on the state of the industry, including the fact that an industry is still in the process of recovering from the effects of past dumping or subsidisation; the magnitude of the actual margin of dumping; actual and potential decline in sales, profits, output, market share, productivity, return on investments and utilisation of capacity; factors affecting Union prices; actual and potential negative effects on cash flow, inventories, employment, wages, growth, ability to raise capital or investments. This list is not exhaustive, nor can any one or more of these factors necessarily give decisive guidance. 6. It must be demonstrated, from all the relevant evidence presented in relation to paragraph 2, that the dumped imports are causing injury within the meaning of this Regulation. Specifically, that shall entail demonstrating that the volume and/or price levels identified pursuant to paragraph 3 are responsible for an impact on the Union industry as provided for in paragraph 5, and that that impact exists to a degree which enables it to be classified as material. 7. Known factors, other than the dumped imports, which at the same time are injuring the Union industry shall also be examined to ensure that the injury caused by those other factors is not attributed to the dumped imports under paragraph 6. Factors which may be considered in that respect shall include: the volume and prices of imports not sold at dumping prices; contraction in demand or changes in the patterns of consumption; restrictive trade practices of, and competition between, third country and Union producers; developments in technology and the export performance; and productivity of the Union industry. 8. The effect of the dumped imports shall be assessed in relation to the production of the Union industry of the like product when available data permit the separate identification of that production on the basis of criteria such as the production process, producers' sales and profits. If such separate identification of that production is not possible, the effects of the dumped imports shall be assessed by examination of the production of the narrowest group or range of products, which includes the like product, for which the necessary information can be provided. 9. A determination of a threat of material injury shall be based on facts and not merely on an allegation, conjecture or remote possibility. The change in circumstances which would create a situation in which the dumping would cause injury must have been clearly foreseen and must be imminent. In making a determination regarding the existence of a threat of material injury, consideration should be given to factors such as: (a) a significant rate of increase of dumped imports into the Union market indicating the likelihood of substantially increased imports; (b) whether there is sufficient freely disposable capacity on the part of the exporter or an imminent and substantial increase in such capacity indicating the likelihood of substantially increased dumped exports to the Union, account being taken of the availability of other export markets to absorb any additional exports; (c) whether imports are entering at prices that would, to a significant degree, depress prices or prevent price increases which otherwise would have occurred, and would probably increase demand for further imports; (d) inventories of the product being investigated. No one of the factors listed above by itself can necessarily give decisive guidance, but the totality of the factors considered shall be such as to lead to the conclusion that further dumped exports are imminent and that, unless protective action is taken, material injury will occur. Article 4 Definition of Union industry 1. For the purposes of this Regulation, the term \u2018Union industry\u2019 shall be interpreted as referring to the Union producers as a whole of the like products or to those of them whose collective output of the products constitutes a major proportion, as defined in Article 5(4), of the total Union production of those products, except that: (a) when producers are related to the exporters or importers, or are themselves importers of the allegedly dumped product, the term \u2018Union industry\u2019 may be interpreted as referring to the rest of the producers; (b) in exceptional circumstances, the territory of the Union may, for the production in question, be divided into two or more competitive markets and the producers within each market may be regarded as a separate industry if: (i) the producers within such a market sell all or almost all of their production of the product in question in that market; and (ii) the demand in that market is not to any substantial degree met by producers of the product in question located elsewhere in the Union. In such circumstances, injury may be found to exist even where a major portion of the total Union industry is not injured, provided that there is a concentration of dumped imports into such an isolated market and provided further that the dumped imports are causing injury to the producers of all or almost all of the production within such a market. 2. For the purpose of paragraph 1, producers shall be considered to be related to exporters or importers only if: (a) one of them directly or indirectly controls the other; (b) both of them are directly or indirectly controlled by a third person; or (c) together they directly or indirectly control a third person, provided that there are grounds for believing or suspecting that the effect of the relationship is such as to cause the producer concerned to behave differently from non-related producers. For the purpose of this paragraph, one shall be deemed to control another when the former is legally or operationally in a position to exercise restraint or direction over the latter. 3. Where the Union industry has been interpreted as referring to the producers in a certain region, the exporters shall be given an opportunity to offer undertakings pursuant to Article 8 in respect of the region concerned. In such cases, when evaluating the Union interest of the measures, special account shall be taken of the interest of the region. If an adequate undertaking is not offered promptly or the situations set out in Article 8(9) and (10) apply, a provisional or definitive duty may be imposed in respect of the Union as a whole. In such cases the duties may, if practicable, be limited to specific producers or exporters. 4. The provisions of Article 3(8) shall be applicable to this Article. Article 5 Initiation of proceedings 1. Except as provided for in paragraph 6, an investigation to determine the existence, degree and effect of any alleged dumping shall be initiated upon a written complaint by any natural or legal person, or any association not having legal personality, acting on behalf of the Union industry. The complaint may be submitted to the Commission or to a Member State, which shall forward it to the Commission. The Commission shall send Member States a copy of any complaint it receives. The complaint shall be deemed to have been lodged on the first working day following its delivery to the Commission by registered mail or the issuing of an acknowledgement of receipt by the Commission. Where, in the absence of any complaint, a Member State is in possession of sufficient evidence of dumping and of resultant injury to the Union industry, it shall immediately communicate such evidence to the Commission. 2. A complaint under paragraph 1 shall include evidence of dumping, injury and a causal link between the allegedly dumped imports and the alleged injury. The complaint shall contain such information as is reasonably available to the complainant on the following: (a) the identity of the complainant and a description of the volume and value of the Union production of the like product by the complainant. Where a written complaint is made on behalf of the Union industry, the complaint shall identify the industry on behalf of which the complaint is made by a list of all known Union producers of the like product (or associations of Union producers of the like product) and, to the extent possible, a description of the volume and value of Union production of the like product accounted for by such producers; (b) a complete description of the allegedly dumped product, the names of the country or countries of origin or export in question, the identity of each known exporter or foreign producer and a list of known persons importing the product in question; (c) the prices at which the product in question is sold when destined for consumption in the domestic markets of the country or countries of origin or export (or, where appropriate, the prices at which the product is sold from the country or countries of origin or export to a third country or countries or on the constructed value of the product) and the export prices or, where appropriate, the prices at which the product is first resold to an independent buyer in the Union; (d) the changes in the volume of the allegedly dumped imports, the effect of those imports on prices of the like product on the Union market and the consequent impact of the imports on the Union industry, as demonstrated by relevant factors and indices having a bearing on the state of the Union industry, such as those listed in Article 3(3) and (5). 3. The Commission shall, as far as possible, examine the accuracy and adequacy of the evidence provided in the complaint, to determine whether there is sufficient evidence to justify the initiation of an investigation. 4. An investigation shall not be initiated pursuant to paragraph 1 unless it has been determined, on the basis of an examination as to the degree of support for, or opposition to, the complaint expressed by Union producers of the like product, that the complaint has been made by, or on behalf of, the Union industry. The complaint shall be considered to have been made by, or on behalf of, the Union industry if it is supported by those Union producers whose collective output constitutes more than 50 % of the total production of the like product produced by that portion of the Union industry expressing either support for or opposition to the complaint. However, no investigation shall be initiated where Union producers expressly supporting the complaint account for less than 25 % of total production of the like product produced by the Union industry. 5. The authorities shall avoid, unless a decision has been taken to initiate an investigation, any publicising of the complaint seeking the initiation of an investigation. However, after receipt of a properly documented complaint and before proceeding to initiate an investigation, the government of the exporting country concerned shall be notified. 6. If, in special circumstances, the Commission decides to initiate an investigation without having received a written complaint by, or on behalf of, the Union industry for the initiation of such an investigation, this shall be done on the basis of sufficient evidence of dumping, injury and a causal link, as described in paragraph 2, to justify such initiation. The Commission shall provide information to the Member States once it has determined the need to initiate such investigation. 7. The evidence of both dumping and injury shall be considered simultaneously in the decision on whether or not to initiate an investigation. A complaint shall be rejected where there is insufficient evidence of either dumping or of injury to justify proceeding with the case. Proceedings shall not be initiated against countries whose imports represent a market share of below 1 %, unless such countries collectively account for 3 % or more of Union consumption. 8. The complaint may be withdrawn prior to initiation, in which case it shall be considered not to have been lodged. 9. Where it is apparent that there is sufficient evidence to justify initiating proceedings, the Commission shall do so within 45 days of the date on which the complaint was lodged and shall publish a notice in the Official Journal of the European Union. Where insufficient evidence has been presented, the complainant shall be so informed within 45 days of the date on which the complaint is lodged with the Commission. The Commission shall provide information to the Member States concerning its analysis of the complaint normally within 21 days of the date on which the complaint is lodged with the Commission. 10. The notice of initiation of proceedings shall announce the initiation of an investigation, indicate the product and countries concerned, give a summary of the information received, and provide that all relevant information is to be communicated to the Commission. It shall state the periods within which interested parties may make themselves known, present their views in writing and submit information if such views and information are to be taken into account during the investigation. It shall also state the period within which interested parties may apply to be heard by the Commission in accordance with Article 6(5). 11. The Commission shall advise the exporters, importers and representative associations of importers or exporters known to it to be concerned, as well as representatives of the exporting country and the complainants, of the initiation of the proceedings and, with due regard to the protection of confidential information, provide the full text of the written complaint received pursuant to paragraph 1 to the known exporters and to the authorities of the exporting country, and make it available upon request to other interested parties involved. Where the number of exporters involved is particularly high, the full text of the written complaint may instead be provided only to the authorities of the exporting country or to the relevant trade association. 12. An anti-dumping investigation shall not hinder the procedures of customs clearance. Article 6 The investigation 1. Following the initiation of proceedings, the Commission, acting in cooperation with the Member States, shall commence an investigation at Union level. Such an investigation shall cover both dumping and injury, and they shall be investigated simultaneously. For the purpose of a representative finding, an investigation period shall be selected which in the case of dumping shall, normally, cover a period of no less than six months immediately prior to the initiation of proceedings. Information relating to a period subsequent to the investigation period shall, normally, not be taken into account. 2. Parties receiving questionnaires used in an anti-dumping investigation shall be given at least 30 days to reply. The time limit for exporters shall be counted from the date of receipt of the questionnaire, which for this purpose shall be deemed to have been received one week from the day on which it was sent to the exporter or transmitted to the appropriate diplomatic representative of the exporting country. An extension to the 30-day period may be granted, due account being taken of the time limits of the investigation, provided that the party shows due cause for such an extension in terms of its particular circumstances. 3. The Commission may request Member States to supply information, and Member States shall take whatever steps are necessary in order to give effect to such requests. They shall send to the Commission the information requested together with the results of all inspections, checks or investigations carried out. Where that information is of general interest or where its transmission has been requested by a Member State, the Commission shall forward it to the Member States, provided that it is not confidential, in which case a non-confidential summary shall be forwarded. 4. The Commission may request Member States to carry out all necessary checks and inspections, particularly amongst importers, traders and Union producers, and to carry out investigations in third countries, provided that the firms concerned give their consent and that the government of the country in question has been officially notified and raises no objection. Member States shall take whatever steps are necessary in order to give effect to such requests from the Commission. Officials of the Commission shall be authorised, if the Commission or a Member State so requests, to assist the officials of Member States in carrying out their duties. 5. The interested parties which have made themselves known in accordance with Article 5(10) shall be heard if they have, within the period prescribed in the notice published in the Official Journal of the European Union, made a written request for a hearing showing that they are an interested party likely to be affected by the result of the proceedings and that there are particular reasons why they should be heard. 6. Opportunities shall, on request, be provided for the importers, exporters, representatives of the government of the exporting country and the complainants, which have made themselves known in accordance with Article 5(10), to meet those parties with adverse interests, so that opposing views may be presented and rebuttal arguments offered. Provision of such opportunities shall take account of the need to preserve confidentiality and of the convenience to the parties. There shall be no obligation on any party to attend a meeting, and failure to do so shall not be prejudicial to that party's case. Oral information provided under this paragraph shall be taken into account in so far as it is subsequently confirmed in writing. 7. The complainants, importers and exporters and their representative associations, users and consumer organisations, which have made themselves known in accordance with Article 5(10), as well as the representatives of the exporting country, may, upon written request, inspect all information made available by any party to an investigation, as distinct from internal documents prepared by the authorities of the Union or its Member States, which is relevant to the presentation of their cases and not confidential within the meaning of Article 19, and is used in the investigation. Such parties may respond to such information and their comments shall be taken into consideration, wherever they are sufficiently substantiated in the response. 8. Except in the circumstances provided for in Article 18, the information which is supplied by interested parties and upon which findings are based shall be examined for accuracy as far as possible. 9. For proceedings initiated pursuant to Article 5(9), an investigation shall, whenever possible, be concluded within one year. In any event, such investigations shall in all cases be concluded within 15 months of initiation, in accordance with the findings made pursuant to Article 8 for undertakings or the findings made pursuant to Article 9 for definitive action. Article 7 Provisional measures 1. Provisional duties may be imposed if: (a) proceedings have been initiated in accordance with Article 5; (b) a notice has been given to that effect and interested parties have been given an adequate opportunity to submit information and make comments in accordance with Article 5(10); (c) a provisional affirmative determination has been made of dumping and consequent injury to the Union industry; and (d) the Union interest calls for intervention to prevent such injury. The provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings. 2. The amount of the provisional anti-dumping duty shall not exceed the margin of dumping as provisionally established, but it should be less than the margin if such lesser duty would be adequate to remove the injury to the Union industry. 3. Provisional duties shall be secured by a guarantee, and the release of the products concerned for free circulation in the Union shall be conditional upon the provision of such a guarantee. 4. The Commission shall adopt provisional measures in accordance with the procedure referred to in Article 15(4). 5. Where a Member State requests immediate intervention by the Commission and where the conditions in paragraph 1 are met, the Commission shall, within a maximum of five working days of receipt of the request, decide whether a provisional anti-dumping duty shall be imposed. 6. Provisional duties may be imposed for six months and extended for a further three months or they may be imposed for nine months. However, they may only be extended, or imposed for a nine-month period, where exporters representing a significant percentage of the trade involved so request or do not object upon notification by the Commission. Article 8 Undertakings 1. On the condition that a provisional affirmative determination of dumping and injury has been made, the Commission may, in accordance with the advisory procedure referred to in Article 15(2), accept satisfactory voluntary undertaking offers submitted by any exporter to revise its prices or to cease exports at dumped prices, if it is satisfied that the injurious effect of the dumping is thereby eliminated. In such a case and as long as such undertakings are in force, provisional duties imposed by the Commission in accordance with Article 7(1), or definitive duties imposed in accordance with Article 9(4), as the case may be, shall not apply to the relevant imports of the product concerned manufactured by the companies referred to in the Commission decision accepting undertakings, as subsequently amended. Price increases under such undertakings shall not be higher than necessary to eliminate the margin of dumping and they should be less than the margin of dumping if such increases would be adequate to remove the injury to the Union industry. 2. Undertakings may be suggested by the Commission, but no exporter shall be obliged to enter into such an undertaking. The fact that exporters do not offer such undertakings, or do not accept an invitation to do so, shall in no way prejudice consideration of the case. However, it may be determined that a threat of injury is more likely to be realised if the dumped imports continue. Undertakings shall not be sought or accepted from exporters unless a provisional affirmative determination of dumping and injury caused by such dumping has been made. Save in exceptional circumstances, undertakings may not be offered later than the end of the period during which representations may be made pursuant to Article 20(5). 3. Undertakings offered need not be accepted if their acceptance is considered impractical, such as where the number of actual or potential exporters is too great, or for other reasons, including reasons of general policy. The exporter concerned may be provided with the reasons for which it is proposed to reject the offer of an undertaking and may be given an opportunity to make comments thereon. The reasons for rejection shall be set out in the definitive decision. 4. Parties which offer an undertaking shall be required to provide a non-confidential version of that undertaking, so that it may be made available to interested parties to the investigation. 5. Where undertakings are accepted, the investigation shall be terminated. The Commission shall terminate the investigation in accordance with the examination procedure referred to in Article 15(3). 6. If the undertakings are accepted, the investigation of dumping and injury shall normally be completed. In such a case, if a negative determination of dumping or injury is made, the undertaking shall automatically lapse, except in cases where such a determination is due in large part to the existence of an undertaking. In such cases it may be required that an undertaking be maintained for a reasonable period. In the event that an affirmative determination of dumping and injury is made, the undertaking shall continue in accordance with its terms and the provisions of this Regulation. 7. The Commission shall require any exporter from which an undertaking has been accepted to provide, periodically, information relevant to the fulfilment of that undertaking, and to permit verification of pertinent data. Non-compliance with such requirements shall be construed as a breach of the undertaking. 8. Where undertakings are accepted from certain exporters during the course of an investigation, they shall, for the purpose of Article 11, be deemed to take effect from the date on which the investigation is concluded for the exporting country. 9. In the case of breach or withdrawal of undertakings by any party to the undertaking, or in the case of withdrawal of acceptance of the undertaking by the Commission, the acceptance of the undertaking shall be withdrawn by Commission Decision or Commission Regulation, as appropriate, and the provisional duty which has been imposed by the Commission in accordance with Article 7 or the definitive duty which has been imposed in accordance with Article 9(4) shall automatically apply, provided that the exporter concerned has, except where that exporter has withdrawn the undertaking, been given an opportunity to comment. The Commission shall provide information to the Member States when it decides to withdraw an undertaking. Any interested party or Member State may submit information showing prima facie evidence of a breach of an undertaking. The subsequent assessment of whether or not a breach of an undertaking has occurred shall normally be concluded within six months, but in no case later than nine months following a duly substantiated request. The Commission may request the assistance of the competent authorities of the Member States in the monitoring of undertakings. 10. A provisional duty may be imposed in accordance with Article 7 on the basis of the best information available where there is reason to believe that an undertaking is being breached, or in the case of breach or withdrawal of an undertaking, where the investigation which led to the undertaking has not been concluded. Article 9 Termination without measures; imposition of definitive duties 1. Where the complaint is withdrawn, proceedings may be terminated unless such termination would not be in the Union's interest. 2. Where protective measures are unnecessary, the investigation or proceedings shall be terminated. The Commission shall terminate the investigation in accordance with the examination procedure referred to in Article 15(3). 3. For proceedings initiated pursuant to Article 5(9), injury shall normally be regarded as negligible where the imports concerned represent less than the volumes set out in Article 5(7). For the same proceedings, there shall be immediate termination where it is determined that the margin of dumping is less than 2 %, expressed as a percentage of the export price, provided that it is only the investigation that shall be terminated where the margin is below 2 % for individual exporters and they shall remain subject to the proceedings and may be reinvestigated in any subsequent review carried out for the country concerned pursuant to Article 11. 4. Where the facts as finally established show that there is dumping and injury caused thereby, and the Union interest calls for intervention in accordance with Article 21, a definitive anti-dumping duty shall be imposed by the Commission acting in accordance with the examination procedure referred to in Article 15(3). Where provisional duties are in force, the Commission shall initiate that procedure no later than one month before the expiry of such duties. The amount of the anti-dumping duty shall not exceed the margin of dumping established but it should be less than the margin if such lesser duty would be adequate to remove the injury to the Union industry. 5. An anti-dumping duty shall be imposed in the appropriate amounts in each case, on a non-discriminatory basis, on imports of a product from all sources found to be dumped and causing injury, except for imports from those sources from which undertakings under the terms of this Regulation have been accepted. The regulation imposing anti-dumping measures shall specify the duty for each supplier or, if that is impracticable, the supplying country concerned. Suppliers which are legally distinct from other suppliers or which are legally distinct from the State may nevertheless be considered as a single entity for the purpose of specifying the duty. For the application of this subparagraph, account may be taken of factors such as the existence of structural or corporate links between the suppliers and the State or between suppliers, control or material influence by the State in respect of pricing and output, or the economic structure of the supplying country. 6. When the Commission has limited its investigation in accordance with Article 17, any anti-dumping duty applied to imports from exporters or producers which have made themselves known in accordance with Article 17 but were not included in the investigation shall not exceed the weighted average margin of dumping established with respect to the parties in the sample, irrespective of whether the normal value for such parties is determined on the basis of Article 2(1) to (6) or point (a) of Article 2(7). For the purpose of this paragraph, the Commission shall disregard any zero and de minimis margins, and margins established in the circumstances referred to in Article 18. Individual duties shall be applied to imports from any exporter or producer which is granted individual treatment, as provided for in Article 17. Article 10 Retroactivity 1. Provisional measures and definitive anti-dumping duties shall only be applied to products which enter free circulation after the time when the measure taken pursuant to Article 7(1) or 9(4), as the case may be, enters into force, subject to the exceptions set out in this Regulation. 2. Where a provisional duty has been applied and the facts as finally established show that there is dumping and injury, the Commission shall decide, irrespective of whether a definitive anti-dumping duty is to be imposed, what proportion of the provisional duty is to be definitively collected. For that purpose, \u2018injury\u2019 shall not include material delay of the establishment of a Union industry, nor threat of material injury, except where it is found that this would, in the absence of provisional measures, have developed into material injury. In all other cases involving such threat or delay, any provisional amounts shall be released and definitive duties can only be imposed from the date on which a final determination of threat or material delay is made. 3. If the definitive anti-dumping duty is higher than the provisional duty, the difference shall not be collected. If the definitive duty is lower than the provisional duty, the duty shall be recalculated. Where a final determination is negative, the provisional duty shall not be confirmed. 4. A definitive anti-dumping duty may be levied on products which were entered for consumption no more than 90 days prior to the date of application of provisional measures but not prior to the initiation of the investigation, provided that: (a) the imports have been registered in accordance with Article 14(5); (b) the importers concerned have been given an opportunity to comment by the Commission; (c) there is, for the product in question, a history of dumping over an extended period, or the importer was aware of, or should have been aware of, the dumping as regards the extent of the dumping and the injury alleged or found; and (d) in addition to the level of imports which caused injury during the investigation period, there is a further substantial rise in imports which, in the light of its timing and volume and other circumstances, is likely to seriously undermine the remedial effect of the definitive anti-dumping duty to be applied. 5. In cases of breach or withdrawal of undertakings, definitive duties may be levied on goods entered for free circulation no more than 90 days before the application of provisional measures, provided that the imports have been registered in accordance with Article 14(5), and that any such retroactive assessment shall not apply to imports entered before the breach or withdrawal of the undertaking. Article 11 Duration, reviews and refunds 1. An anti-dumping measure shall remain in force only as long as, and to the extent that, it is necessary to counteract the dumping which is causing injury. 2. A definitive anti-dumping measure shall expire five years from its imposition or five years from the date of the conclusion of the most recent review which has covered both dumping and injury, unless it is determined in a review that the expiry would be likely to lead to a continuation or recurrence of dumping and injury. Such an expiry review shall be initiated on the initiative of the Commission, or upon a request made by or on behalf of Union producers, and the measure shall remain in force pending the outcome of that review. An expiry review shall be initiated where the request contains sufficient evidence that the expiry of the measures would be likely to result in a continuation or recurrence of dumping and injury. Such likelihood may, for example, be indicated by evidence of continued dumping and injury or evidence that the removal of injury is partly or solely due to the existence of measures or evidence that the circumstances of the exporters, or market conditions, are such that they would indicate the likelihood of further injurious dumping. In carrying out investigations under this paragraph, the exporters, importers, the representatives of the exporting country and the Union producers shall be provided with the opportunity to amplify, rebut or comment on the matters set out in the review request, and conclusions shall be reached with due account taken of all relevant and duly documented evidence presented in relation to the question as to whether the expiry of measures would be likely, or unlikely, to lead to the continuation or recurrence of dumping and injury. A notice of impending expiry shall be published in the Official Journal of the European Union at an appropriate time in the final year of the period of application of the measures as defined in this paragraph. Thereafter, the Union producers shall, no later than three months before the end of the five-year period, be entitled to lodge a review request in accordance with the second subparagraph. A notice announcing the actual expiry of measures pursuant to this paragraph shall also be published. 3. The need for the continued imposition of measures may also be reviewed, where warranted, on the initiative of the Commission or at the request of a Member State or, provided that a reasonable period of time of at least one year has elapsed since the imposition of the definitive measure, upon a request by any exporter or importer or by the Union producers which contains sufficient evidence substantiating the need for such an interim review. An interim review shall be initiated where the request contains sufficient evidence that the continued imposition of the measure is no longer necessary to offset dumping and/or that the injury would be unlikely to continue or recur if the measure were removed or varied, or that the existing measure is not, or is no longer, sufficient to counteract the dumping which is causing injury. In carrying out investigations pursuant to this paragraph, the Commission may, inter alia, consider whether the circumstances with regard to dumping and injury have changed significantly, or whether existing measures are achieving the intended results in removing the injury previously established under Article 3. In those respects, account shall be taken in the final determination of all relevant and duly documented evidence. 4. A review shall also be carried out for the purpose of determining individual margins of dumping for new exporters in the exporting country in question which have not exported the product during the period of investigation on which the measures were based. The review shall be initiated where a new exporter or producer can show that it is not related to any of the exporters or producers in the exporting country which are subject to the anti-dumping measures on the product, and that it has actually exported to the Union following the investigation period, or where it can demonstrate that it has entered into an irrevocable contractual obligation to export a significant quantity to the Union. A review for a new exporter shall be initiated and carried out on an accelerated basis after Union producers have been given an opportunity to comment. The Commission Regulation initiating a review shall repeal the duty in force with regard to the new exporter concerned by amending the regulation which has imposed such duty, and by making imports subject to registration in accordance with Article 14(5) in order to ensure that, should the review result in a determination of dumping in respect of such an exporter, anti-dumping duties can be levied retroactively to the date of the initiation of the review. The provisions of this paragraph shall not apply where duties have been imposed under Article 9(6). 5. The relevant provisions of this Regulation with regard to procedures and the conduct of investigations, excluding those relating to time limits, shall apply to any review carried out pursuant to paragraphs 2, 3 and 4. Reviews carried out pursuant to paragraphs 2 and 3 shall be carried out expeditiously and shall normally be concluded within 12 months of the date of initiation of the review. In any event, reviews pursuant to paragraphs 2 and 3 shall in all cases be concluded within 15 months of initiation. Reviews pursuant to paragraph 4 shall in all cases be concluded within nine months of the date of initiation. If a review carried out pursuant to paragraph 2 is initiated while a review under paragraph 3 is ongoing in the same proceedings, the review pursuant to paragraph 3 shall be concluded at the same time as the review pursuant to paragraph 2. If the investigation is not completed within the deadlines specified in the second, third and fourth subparagraphs, the measures shall: \u2014 expire in investigations pursuant to paragraph 2, \u2014 expire in the case of investigations carried out pursuant to paragraphs 2 and 3 in parallel, where either the investigation pursuant to paragraph 2 was initiated while a review under paragraph 3 was ongoing in the same proceedings or where such reviews were initiated at the same time, or \u2014 remain unchanged in investigations pursuant to paragraphs 3 and 4. A notice announcing the actual expiry or maintenance of the measures pursuant to this paragraph shall then be published in the Official Journal of the European Union. 6. Reviews pursuant to this Article shall be initiated by the Commission. The Commission shall decide whether or not to initiate reviews pursuant to paragraph 2 of this Article in accordance with the advisory procedure referred to in Article 15(2). The Commission shall also provide information to the Member States once an operator or a Member State has submitted a request justifying the initiation of a review pursuant to paragraphs 3 and 4 of this Article and the Commission has completed its analysis thereof, or once the Commission has itself determined that the need for the continued imposition of measures should be reviewed. Where warranted by reviews, measures shall, in accordance with the examination procedure referred to in Article 15(3), be repealed or maintained pursuant to paragraph 2 of this Article, or repealed, maintained or amended pursuant to paragraphs 3 and 4 of this Article. Where measures are repealed for individual exporters, but not for the country as a whole, such exporters shall remain subject to the proceedings and may, automatically, be reinvestigated in any subsequent review carried out for that country pursuant to this Article. 7. Where a review of measures pursuant to paragraph 3 is in progress at the end of the period of application of measures as defined in paragraph 2, such a review shall also cover the circumstances set out in paragraph 2. 8. Notwithstanding paragraph 2, an importer may request reimbursement of duties collected where it is shown that the dumping margin, on the basis of which duties were paid, has been eliminated, or reduced to a level which is below the level of the duty in force. In requesting a refund of anti-dumping duties, the importer shall submit an application to the Commission. The application shall be submitted via the Member State of the territory in which the products were released for free circulation, within six months of the date on which the amount of the definitive duties to be levied was duly determined by the competent authorities or of the date on which a decision was made definitively to collect the amounts secured by way of provisional duty. Member States shall forward the request to the Commission forthwith. An application for refund shall only be considered to be duly supported by evidence where it contains precise information on the amount of refund of anti-dumping duties claimed and all customs documentation relating to the calculation and payment of such amount. It shall also include evidence, for a representative period, of normal values and export prices to the Union for the exporter or producer to which the duty applies. In cases where the importer is not associated with the exporter or producer concerned and such information is not immediately available, or where the exporter or producer is unwilling to release it to the importer, the application shall contain a statement from the exporter or producer that the dumping margin has been reduced or eliminated, as specified in this Article, and that the relevant supporting evidence will be provided to the Commission. Where such evidence is not forthcoming from the exporter or producer within a reasonable period of time the application shall be rejected. The Commission shall decide whether and to what extent the application should be granted, or it may decide at any time to initiate an interim review, whereupon the information and findings from such a review carried out in accordance with the provisions applicable for such reviews shall be used to determine whether and to what extent a refund is justified. The Commission shall provide information to the Member States once it has completed its analysis of the application. Refunds of duties shall normally take place within 12 months, and in no circumstances more than 18 months after the date on which a request for a refund, duly supported by evidence, has been made by an importer of the product subject to the anti-dumping duty. The payment of any refund authorised should normally be made by Member States within 90 days of the Commission's decision. 9. In all review or refund investigations carried out pursuant to this Article, the Commission shall, provided that circumstances have not changed, apply the same methodology as in the investigation which led to the duty, with due account being taken of Article 2, and in particular paragraphs 11 and 12 thereof, and of Article 17. 10. In any investigation carried our pursuant to this Article, the Commission shall examine the reliability of export prices in accordance with Article 2. However, where it is decided to construct the export price in accordance with Article 2(9), it shall calculate it with no deduction for the amount of anti-dumping duties paid when conclusive evidence is provided that the duty is duly reflected in resale prices and the subsequent selling prices in the Union. Article 12 Absorption 1. Where the Union industry or any other interested party submit, normally within two years from the entry into force of the measures, sufficient information showing that, after the original investigation period and prior to or following the imposition of measures, export prices have decreased or that there has been no movement, or insufficient movement, in the resale prices or subsequent selling prices of the imported product in the Union, the Commission may reopen the investigation to examine whether the measure has had effects on the abovementioned prices. The Commission shall provide information to the Member States once an interested party has submitted sufficient information justifying the reopening of the investigation and the Commission has completed its analysis thereof. The investigation may also be reopened, under the conditions set out in the first subparagraph, on the initiative of the Commission or at the request of a Member State. 2. During a reinvestigation pursuant to this Article, exporters, importers and Union producers shall be provided with an opportunity to clarify the situation with regard to resale prices and subsequent selling prices. If it is concluded that the measure should have led to movements in such prices, then, in order to remove the injury previously established in accordance with Article 3, export prices shall be reassessed in accordance with Article 2 and dumping margins shall be recalculated to take account of the reassessed export prices. Where it is considered that the conditions of Article 12(1) are met due to a fall in export prices which has occurred after the original investigation period and prior to or following the imposition of measures, dumping margins may be recalculated to take account of such lower export prices. 3. Where a reinvestigation pursuant to this Article shows increased dumping, the measures in force may be amended by the Commission acting in accordance with the examination procedure referred to in Article 15(3), in accordance with the new findings on export prices. The amount of the anti-dumping duty imposed pursuant to this Article shall not exceed twice the amount of the duty imposed initially. 4. The relevant provisions of Articles 5 and 6 shall apply to any reinvestigation carried out pursuant to this Article, except that such reinvestigation shall be carried out expeditiously and shall normally be concluded within six months of the date of initiation of the reinvestigation. In any event, such reinvestigations shall in all cases be concluded within nine months of initiation of the reinvestigation. If the reinvestigation is not completed within the deadlines specified in the first subparagraph, measures shall remain unchanged. A notice announcing the maintenance of the measures pursuant to this paragraph shall be published in the Official Journal of the European Union. 5. Alleged changes in normal value shall only be taken into account under this Article where complete information on revised normal values, duly substantiated by evidence, is made available to the Commission within the time limits set out in the notice of initiation of an investigation. Where an investigation involves a re-examination of normal values, imports may be made subject to registration in accordance with Article 14(5) pending the outcome of the reinvestigation. Article 13 Circumvention 1. Anti-dumping duties imposed pursuant to this Regulation may be extended to imports from third countries of the like product, whether slightly modified or not, or to imports of the slightly modified like product from the country subject to measures, or parts thereof, when circumvention of the measures in force is taking place. Anti-dumping duties not exceeding the residual anti-dumping duty imposed in accordance with Article 9(5) may be extended to imports from companies benefiting from individual duties in the countries subject to measures when circumvention of the measures in force is taking place. Circumvention shall be defined as a change in the pattern of trade between third countries and the Union or between individual companies in the country subject to measures and the Union, which stems from a practice, process or work for which there is insufficient due cause or economic justification other than the imposition of the duty, and where there is evidence of injury or that the remedial effects of the duty are being undermined in terms of the prices and/or quantities of the like product, and where there is evidence of dumping in relation to the normal values previously established for the like product, if necessary in accordance with the provisions of Article 2. The practice, process or work referred to in the third subparagraph includes, inter alia: (a) the slight modification of the product concerned to make it fall under customs codes which are normally not subject to the measures, provided that the modification does not alter its essential characteristics; (b) the consignment of the product subject to measures via third countries; (c) the reorganisation by exporters or producers of their patterns and channels of sales in the country subject to measures in order to eventually have their products exported to the Union through producers benefiting from an individual duty rate lower than that applicable to the products of the manufacturers; (d) in the circumstances indicated in paragraph 2, the assembly of parts by an assembly operation in the Union or a third country. 2. An assembly operation in the Union or a third country shall be considered to circumvent the measures in force where: (a) the operation started or substantially increased since, or just prior to, the initiation of the anti-dumping investigation and the parts concerned are from the country subject to measures; and (b) the parts constitute 60 % or more of the total value of the parts of the assembled product, except that in no case shall circumvention be considered to be taking place where the value added to the parts brought in, during the assembly or completion operation, is greater than 25 % of the manufacturing cost; and (c) the remedial effects of the duty are being undermined in terms of the prices and/or quantities of the assembled like product and there is evidence of dumping in relation to the normal values previously established for the like or similar products. 3. Investigations shall be initiated pursuant to this Article on the initiative of the Commission or at the request of a Member State or any interested party on the basis of sufficient evidence regarding the factors set out in paragraph 1. Initiations shall be made by Commission Regulation which may also instruct customs authorities to subject imports to registration in accordance with Article 14(5) or to request guarantees. The Commission shall provide information to the Member States once an interested party or a Member State has submitted a request justifying the initiation of an investigation and the Commission has completed its analysis thereof, or where the Commission has itself determined that there is a need to initiate an investigation. Investigations shall be carried out by the Commission. The Commission may be assisted by customs authorities and the investigation shall be concluded within nine months. Where the facts as finally ascertained justify the extension of measures, this shall be done by the Commission acting in accordance with the examination procedure referred to in Article 15(3). The extension shall take effect from the date on which registration was imposed pursuant to Article 14(5), or on which guarantees were requested. The relevant procedural provisions of this Regulation concerning the initiation and the conduct of investigations shall apply pursuant to this Article. 4. Imports shall not be subject to registration pursuant to Article 14(5) or measures where they are traded by companies which benefit from exemptions. Requests for exemptions duly supported by evidence shall be submitted within the time limits established in the Commission regulation initiating the investigation. Where the circumventing practice, process or work takes place outside the Union, exemptions may be granted to producers of the product concerned that can show that they are not related to any producer subject to the measures and that are found not to be engaged in circumvention practices as defined in paragraphs 1 and 2 of this Article. Where the circumventing practice, process or work takes place inside the Union, exemptions may be granted to importers that can show that they are not related to producers subject to the measures. Those exemptions shall be granted by decision of the Commission and shall remain valid for the period and under the conditions set down therein. The Commission shall provide information to the Member States once it has concluded its analysis. Provided that the conditions set in Article 11(4) are met, exemptions may also be granted after the conclusion of the investigation leading to the extension of the measures. Provided that at least one year has lapsed from the extension of the measures, and in case the number of parties requesting or potentially requesting an exemption is significant, the Commission may decide to initiate a review of the extension of the measures. Any such review shall be conducted in accordance with the provisions of Article 11(5) as applicable to reviews pursuant to Article 11(3). 5. Nothing in this Article shall preclude the normal application of the provisions in force concerning customs duties. Article 14 General provisions 1. Provisional or definitive anti-dumping duties shall be imposed by regulation, and collected by Member States in the form, at the rate specified and according to the other criteria laid down in the regulation imposing such duties. Such duties shall also be collected independently of the customs duties, taxes and other charges normally imposed on imports. No product shall be subject to both anti-dumping and countervailing duties for the purpose of dealing with one and the same situation arising from dumping or from export subsidisation. 2. Regulations imposing provisional or definitive anti-dumping duties, and regulations or decisions accepting undertakings or terminating investigations or proceedings, shall be published in the Official Journal of the European Union. Such regulations or decisions shall contain in particular, and with due regard to the protection of confidential information, the names of the exporters, if possible, or of the countries involved, a description of the product and a summary of the material facts and considerations relevant to the dumping and injury determinations. In each case, a copy of the regulation or decision shall be sent to known interested parties. The provisions of this paragraph shall apply mutatis mutandis to reviews. 3. Special provisions, in particular with regard to the common definition of the concept of origin, as contained in Regulation (EU) No 952/2013 of the European Parliament and of the Council (7), may be adopted pursuant to this Regulation. 4. In the Union interest, measures imposed pursuant to this Regulation may be suspended by a decision of the Commission in accordance with the advisory procedure referred to in Article 15(2) for a period of nine months. The suspension may be extended for a further period, not exceeding one year, by the Commission acting in accordance with the advisory procedure referred to in Article 15(2). Measures may only be suspended where market conditions have temporarily changed to an extent that injury would be unlikely to resume as a result of the suspension, and provided that the Union industry has been given an opportunity to comment and those comments have been taken into account. Measures may at any time be reinstated in accordance with the advisory procedure referred to in Article 15(2) if the reason for suspension is no longer applicable. 5. The Commission may, after having informed the Member States in due time, direct the customs authorities to take the appropriate steps to register imports, so that measures may subsequently be applied against those imports from the date of such registration. Imports may be made subject to registration following a request from the Union industry which contains sufficient evidence to justify such action. Registration shall be introduced by regulation which shall specify the purpose of the action and, if appropriate, the estimated amount of possible future liability. Imports shall not be made subject to registration for a period longer than nine months. 6. Member States shall report to the Commission every month on the import trade in products subject to investigation and to measures, and on the amount of duties collected pursuant to this Regulation. 7. Without prejudice to paragraph 6, the Commission may request Member States, on a case-by-case basis, to supply information necessary to monitor efficiently the application of measures. In this respect, the provisions of Article 6(3) and (4) shall apply. Any data submitted by Member States pursuant to this Article shall be covered by the provisions of Article 19(6). Article 15 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 thereof, shall apply. 5. Pursuant to Article 3(5) of Regulation (EU) No 182/2011, where the written procedure is used to adopt definitive measures pursuant to paragraph 3 of this Article, or to decide on the initiation or non-initiation of expiry reviews pursuant to Article 11(6) of this Regulation, that procedure shall be terminated without result where, within the time limit set down by the chair, the chair so decides or a majority of committee members as defined in Article 5(1) of Regulation (EU) No 182/2011 so request. Where the written procedure is used in other instances where there has been a discussion of the draft measure in the committee, such procedure shall be terminated without result where, within the time limit set down by the chair, the chair so decides or a simple majority of committee members so request. Where the written procedure is used in other instances where there has not been a discussion of the draft measure in the committee, such procedure shall be terminated without result where, within the time limit set down by the chair, the chair so decides or at least a quarter of committee members so request. 6. The committee may consider any matter relating to the application of this Regulation, raised by the Commission or at the request of a Member State. Member States may request information and may exchange views in the committee or directly with the Commission. Article 16 Verification visits 1. The Commission shall, where it considers it appropriate, carry out visits to examine the records of importers, exporters, traders, agents, producers, trade associations and organisations and to verify information provided on dumping and injury. In the absence of a proper and timely reply, the Commission may choose not to carry out a verification visit. 2. The Commission may carry out investigations in third countries as required, provided that it obtains the agreement of the firms concerned, that it notifies the representatives of the government of the country in question and that the latter does not object to the investigation. As soon as the agreement of the firms concerned has been obtained, the Commission shall notify the authorities of the exporting country of the names and addresses of the firms to be visited and the dates agreed. 3. The firms concerned shall be advised of the nature of the information to be verified during verification visits and of any further information which needs to be provided during such visits, though this does not preclude requests, made during the verification, for further details to be provided in the light of information obtained. 4. In investigations carried out pursuant to paragraphs 1, 2 and 3, the Commission shall be assisted by officials of those Member States which so request. Article 17 Sampling 1. In cases where the number of complainants, exporters or importers, types of product or transactions is large, the investigation may be limited to a reasonable number of parties, products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection, or to the largest representative volume of production, sales or exports which can reasonably be investigated within the time available. 2. The final selection of parties, types of products or transactions made under these sampling provisions shall rest with the Commission, though preference shall be given to choosing a sample in consultation with, and with the consent of, the parties concerned, provided that such parties make themselves known and make sufficient information available, within three weeks of initiation of the investigation, to enable a representative sample to be chosen. 3. In cases where the investigation has been limited in accordance with this Article, an individual margin of dumping shall, nevertheless, be calculated for any exporter or producer not initially selected who submits the necessary information within the time limits provided for in this Regulation, except where the number of exporters or producers is so large that individual examinations would be unduly burdensome and would prevent completion of the investigation in good time. 4. Where it is decided to sample and there is a degree of non-cooperation by some or all of the parties selected which is likely to materially affect the outcome of the investigation, a new sample may be selected. However, if a material degree of non-cooperation persists or there is insufficient time to select a new sample, the relevant provisions of Article 18 shall apply. Article 18 Non-cooperation 1. In cases in which any interested party refuses access to, or otherwise does not provide, necessary information within the time limits provided for in this Regulation, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made on the basis of the facts available. Where it is found that any interested party has supplied false or misleading information, that information shall be disregarded and use may be made of facts available. Interested parties shall be made aware of the consequences of non-cooperation. 2. Failure to give a computerised response shall not be deemed to constitute non-cooperation, provided that the interested party shows that presenting the response as requested would result in an unreasonable extra burden or unreasonable additional cost. 3. Where the information submitted by an interested party is not ideal in all respects, it shall nevertheless not be disregarded, provided that any deficiencies are not such as to cause undue difficulty in arriving at a reasonably accurate finding and that the information is appropriately submitted in good time and is verifiable, and that the party has acted to the best of its ability. 4. If evidence or information is not accepted, the supplying party shall be informed forthwith of the reasons therefor and shall be granted an opportunity to provide further explanations within the time limit specified. If the explanations are considered unsatisfactory, the reasons for rejection of such evidence or information shall be disclosed and given in published findings. 5. If determinations, including those regarding normal value, are based on the provisions of paragraph 1, including the information supplied in the complaint, it shall, where practicable and with due regard to the time limits of the investigation, be checked by reference to information from other independent sources which may be available, such as published price lists, official import statistics and customs returns, or information obtained from other interested parties during the investigation. Such information may include relevant data pertaining to the world market or other representative markets, where appropriate. 6. If an interested party does not cooperate, or cooperates only partially, so that relevant information is thereby withheld, the result of the investigation may be less favourable to the party than if it had cooperated. Article 19 Confidentiality 1. Any information which is by nature confidential (for example, because its disclosure would be of significant competitive advantage to a competitor or would have a significantly adverse effect upon a person supplying the information or upon a person from whom the person supplying the information has acquired the information) or which is provided on a confidential basis by parties to an investigation shall, if good cause is shown, be treated as such by the authorities. 2. Interested parties providing confidential information shall be required to provide non-confidential summaries thereof. Those summaries shall be in sufficient detail to permit a reasonable understanding of the substance of the information submitted in confidence. In exceptional circumstances, such parties may indicate that such information is not capable of being summarised. In such exceptional circumstances, a statement of the reasons why such summarisation is not possible shall be provided. 3. If it is considered that a request for confidentiality is not warranted and if the supplier of the information is either unwilling to make the information available or to authorise its disclosure in generalised or summary form, such information may be disregarded unless it can be satisfactorily demonstrated from appropriate sources that the information is correct. Requests for confidentiality shall not be arbitrarily rejected. 4. This Article shall not preclude the disclosure of general information by the Union authorities, and, in particular, of the reasons on which decisions taken pursuant to this Regulation are based, or disclosure of the evidence relied on by the Union authorities in so far as is necessary to explain those reasons in court proceedings. Such disclosure shall take into account the legitimate interests of the parties concerned that their business secrets not be divulged. 5. The Commission and Member States, including the officials of either, shall not reveal any information received pursuant to this Regulation for which confidential treatment has been requested by its supplier, without specific permission from that supplier. Exchanges of information between the Commission and Member States, or any internal documents prepared by the authorities of the Union or the Member States, shall not be divulged except as specifically provided for in this Regulation. 6. Information received pursuant to this Regulation shall be used only for the purpose for which it was requested. This provision shall not preclude the use of information received in the context of one investigation for the purpose of initiating other investigations within the same proceedings in relation to the product concerned. Article 20 Disclosure 1. The complainants, importers and exporters and their representative associations, and representatives of the exporting country, may request disclosure of the details underlying the essential facts and considerations on the basis of which provisional measures have been imposed. Requests for such disclosure shall be made in writing immediately following the imposition of provisional measures, and the disclosure shall be made in writing as soon as possible thereafter. 2. The parties mentioned in paragraph 1 may request final disclosure of the essential facts and considerations on the basis of which it is intended to recommend the imposition of definitive measures, or the termination of an investigation or proceedings without the imposition of measures, particular attention being paid to the disclosure of any facts or considerations which are different from those used for any provisional measures. 3. Requests for final disclosure, as defined in paragraph 2, shall be addressed to the Commission in writing and be received, in cases where a provisional duty has been imposed, no later than one month after publication of the imposition of that duty. Where a provisional duty has not been imposed, parties shall be provided with an opportunity to request final disclosure within time limits set by the Commission. 4. Final disclosure shall be given in writing. It shall be made, due regard being had to the protection of confidential information, as soon as possible and, normally, no later than one month prior to the initiation of the procedures set out in Article 9. Where the Commission is not in a position to disclose certain facts or considerations at that time, they shall be disclosed as soon as possible thereafter. Disclosure shall not prejudice any subsequent decision which may be taken by the Commission, but where such a decision is based on any different facts and considerations they shall be disclosed as soon as possible. 5. Representations made after final disclosure is given shall be taken into consideration only if received within a period to be set by the Commission in each case, which shall be at least 10 days, due consideration being given to the urgency of the matter. A shorter period may be set whenever an additional final disclosure has to be made. Article 21 Union interest 1. A determination as to whether the Union's interest calls for intervention shall be based on an appreciation of all the various interests taken as a whole, including the interests of the domestic industry and users and consumers. A determination pursuant to this Article shall only be made where all parties have been given the opportunity to make their views known pursuant to paragraph 2. In such an examination, the need to eliminate the trade distorting effects of injurious dumping and to restore effective competition shall be given special consideration. Measures, as determined on the basis of the dumping and injury found, may not be applied where the authorities, on the basis of all the information submitted, can clearly conclude that it is not in the Union's interest to apply such measures. 2. In order to provide a sound basis on which the authorities can take account of all views and information in the decision as to whether or not the imposition of measures is in the Union's interest, the complainants, importers and their representative associations, representative users and representative consumer organisations may, within the time limits specified in the notice of initiation of the anti-dumping investigation, make themselves known and provide information to the Commission. Such information, or appropriate summaries thereof, shall be made available to the other parties specified in this Article, and they shall be entitled to respond to such information. 3. The parties which have acted in accordance with paragraph 2 may request a hearing. Such requests shall be granted when they are submitted within the time limits set in paragraph 2, and when they set out the reasons, in terms of the Union's interest, why the parties should be heard. 4. The parties which have acted in accordance with paragraph 2 may provide comments on the application of any provisional duties. Such comments shall be received within 25 days of the date of application of such measures if they are to be taken into account and they, or appropriate summaries thereof, shall be made available to other parties who shall be entitled to respond to such comments. 5. The Commission shall examine the information which is properly submitted and the extent to which it is representative, and the results of such analysis, together with an opinion on its merits, shall be transmitted to the committee referred to in Article 15 as part of the draft measure submitted pursuant to Article 9. The views expressed in the committee should be taken into account by the Commission under the conditions provided for in Regulation (EU) No 182/2011. 6. The parties which have acted in conformity with paragraph 2 may request that the facts and considerations on which final decisions are likely to be taken be made available to them. Such information shall be made available to the extent possible and without prejudice to any subsequent decision taken by the Commission. 7. Information shall only be taken into account where it is supported by actual evidence which substantiates its validity. Article 22 Final provisions This Regulation shall not preclude the application of: (a) any special rules laid down in agreements concluded between the Union and third countries; (b) the Union Regulations in the agricultural sector and Council Regulations (EC) No 1667/2006 (8), (EC) No 614/2009 (9) and (EC) No 1216/2009 (10). This Regulation shall operate by way of complement to those Regulations and in derogation from any provisions thereof which preclude the application of anti-dumping duties; (c) special measures, provided that such action does not run counter to obligations under the General Agreement on Tariffs and Trade 1994. Article 23 Report 1. The Commission shall, with due regard to the protection of confidential information within the meaning of Article 19, present an annual report on the application and implementation of this Regulation to the European Parliament and to the Council. The report shall include information about the application of provisional and definitive measures, the termination of investigations without measures, reinvestigations, reviews and verification visits, and the activities of the various bodies responsible for monitoring the implementation of this Regulation and fulfilment of the obligations arising therefrom. 2. The European Parliament may, within one month of the Commission presenting the report, invite the Commission to an ad hoc meeting of its responsible committee to present and explain any issues related to the implementation of this Regulation. 3. No later than six months after presenting the report to the European Parliament and to the Council, the Commission shall make the report public. Article 24 Repeal Regulation (EC) No 1225/2009 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 25 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 8 June 2016. For the European Parliament The President M. SCHULZ For the Council The President A.G. KOENDERS (1) Position of the European Parliament of 10 May 2016 (not yet published in the Official Journal) and Council decision of 30 May 2016. (2) Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (OJ L 343, 22.12.2009, p. 51). (3) See Annex I. (4) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (5) Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558). (6) Including Albania, Armenia, Azerbaijan, Belarus, Georgia, Kyrgyzstan, Moldova, Mongolia, North Korea, Tajikistan, Turkmenistan and Uzbekistan. (7) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (8) Council Regulation (EC) No 1667/2006 of 7 November 2006 on glucose and lactose (OJ L 312, 11.11.2006, p. 1). (9) Council Regulation (EC) No 614/2009 of 7 July 2009 on the common system of trade for ovalbumin and lactalbumin (OJ L 181, 14.7.2009, p. 8). (10) Council Regulation (EC) No 1216/2009 of 30 November 2009 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products (OJ L 328, 15.12.2009, p. 10). ANNEX I REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Council Regulation (EC) No 1225/2009 (OJ L 343, 22.12.2009, p. 51) Regulation (EU) No 765/2012 of the European Parliament and of the Council (OJ L 237, 3.9.2012, p. 1) Regulation (EU) No 1168/2012 of the European Parliament and of the Council (OJ L 344, 14.12.2012, p. 1) Regulation (EU) No 37/2014 of the European Parliament and of the Council (OJ L 18, 21.1.2014, p. 1) Only point 22 of the Annex ANNEX II CORRELATION TABLE Regulation (EC) No 1225/2009 This Regulation Articles 1 to 4 Articles 1 to 4 Article 5(1) to (9) Article 5(1) to (9) Article 5(10), first sentence Article 5(10), first subparagraph Article 5(10), second and third sentence Article 5(10), second subparagraph Article 5(11) and (12) Article 5(11) and (12) Article 6(1), first and second sentence Article 6(1), first subparagraph Article 6(1), third sentence Article 6(1), second subparagraph Article 6(1), fourth sentence Article 6(1), third subparagraph Article 6(2) Article 6(2) Article 6(3), first sentence Article 6(3), first subparagraph Article 6(3), second sentence Article 6(3), second subparagraph Article 6(3), third sentence Article 6(3), third subparagraph Article 6(4), first sentence Article 6(4), first subparagraph Article 6(4), second sentence Article 6(4), second subparagraph Article 6(4), third sentence Article 6(4), third subparagraph Article 6(5) Article 6(5) Article 6(6), first sentence Article 6(6), first subparagraph Article 6(6), second sentence Article 6(6), second subparagraph Article 6(6), third sentence Article 6(6), third subparagraph Article 6(6), fourth sentence Article 6(6), fourth subparagraph Article 6(7), first sentence Article 6(7), first subparagraph Article 6(7), second sentence Article 6(7), second subparagraph Article 6(8) and (9) Article 6(8) and (9) Article 7(1), first sentence Article 7(1), first subparagraph Article 7(1), second sentence Article 7(1), second subparagraph Article 7(2) to (5) Article 7(2) to (5) Article 7(7) Article 7(6) Article 8(1), first sentence Article 8(1), first subparagraph Article 8(1), second sentence Article 8(1), second subparagraph Article 8(1), third sentence Article 8(1), third subparagraph Article 8(2), first and second sentence Article 8(2), first subparagraph Article 8(2), third and fourth sentence Article 8(2), second subparagraph Article 8(2), fifth sentence Article 8(2), third subparagraph Article 8(3), (4) and (5) Article 8(3), (4) and (5) Article 8(6), first and second sentence Article 8(6), first subparagraph Article 8(6), third sentence Article 8(6), second subparagraph Article 8(7) and (8) Article 8(7) and (8) Article 8(9), first subparagraph Article 8(9), first subparagraph Article 8(9), second subparagraph, first and second sentence Article 8(9), second subparagraph Article 8(9), second subparagraph, third sentence Article 8(9), third subparagraph Article 8(10) Article 8(10) Article 9(1), (2) and (3) Article 9(1), (2) and (3) Article 9(4), first sentence Article 9(4), first subparagraph Article 9(4), second sentence Article 9(4), second subparagraph Article 9(5) Article 9(5) Article 9(6), first sentence Article 9(6), first subparagraph Article 9(6), second sentence Article 9(6), second subparagraph Article 9(6), third sentence Article 9(6), third subparagraph Article 10(1) Article 10(1) Article 10(2), first sentence Article 10(2), first subparagraph Article 10(2), second and third sentence Article 10(2), second subparagraph Article 10(3) Article 10(3) Article 10(4), introductory wording Article 10(4), introductory wording and points (a) and (b) Article 10(4)(a) Article 10(4)(c) Article 10(4)(b) Article 10(4)(d) Article 10(5) Article 10(5) Article 11(1) to (4) Article 11(1) to (4) Article 11(5), first subparagraph, first sentence Article 11(5), first subparagraph Article 11(5), first subparagraph, second and third sentence Article 11(5), second subparagraph Article 11(5), first subparagraph, fourth sentence Article 11(5), third subparagraph Article 11(5), first subparagraph, fifth sentence Article 11(5), fourth subparagraph Article 11(5), second subparagraph Article 11(5), fifth subparagraph Article 11(5), third subparagraph Article 11(5), sixth subparagraph Article 11(6), first, second and third sentence Article 11(6), first subparagraph Article 11(6), fourth sentence Article 11(6), second subparagraph Article 11(6), fifth sentence Article 11(6), third subparagraph Article 11(7) Article 11(7) Article 11(8), first, second and third subparagraph Article 11(8), first, second and third subparagraph Article 11(8), fourth subparagraph, first and second sentence Article 11(8), fourth subparagraph Article 11(8), fourth subparagraph, third sentence Article 11(8), fifth subparagraph Article 11(8), fourth subparagraph, fourth sentence Article 11(8), sixth subparagraph Article 11(9) and (10) Article 11(9) and (10) Article 12 Article 12 Article 13(1), first subparagraph, first sentence Article 13(1), first subparagraph Article 13(1), first subparagraph, second sentence Article 13(1), second subparagraph Article 13(1), first subparagraph, third sentence Article 13(1), third subparagraph Article 13(1), second subparagraph Article 13(1), fourth subparagraph Article 13(2) and (3) Article 13(2) and (3) Article 13(4), first subparagraph, first sentence Article 13(4), first subparagraph Article 13(4), first subparagraph, second sentence Article 13(4), second subparagraph Article 13(4), first subparagraph, third sentence Article 13(4), third subparagraph Article 13(4), first subparagraph, fourth sentence Article 13(4), fourth subparagraph Article 13(4), second subparagraph Article 13(4), fifth subparagraph Article 13(4), third subparagraph Article 13(4), sixth subparagraph Article 13(4), fourth subparagraph Article 13(4), seventh subparagraph Article 13(5) Article 13(5) Article 14(1), first and second sentence Article 14(1), first subparagraph Article 14(1), third sentence Article 14(1), second subparagraph Article 14(2), first sentence Article 14(2), first subparagraph Article 14(2), second, third and fourth sentence Article 14(2), second subparagraph Article 14(3) Article 14(3) Article 14(4), first and second sentence Article 14(4), first subparagraph Article 14(4), third and fourth sentence Article 14(4), second subparagraph Article 14(5), (6) and (7) Article 14(5), (6) and (7) Articles 15 and 16 Articles 15 and 16 Article 17(1), (2) and (3) Article 17(1), (2) and (3) Article 17(4), first sentence Article 17(4), first subparagraph Article 17(4), second sentence Article 17(4), second subparagraph Article 18(1), first sentence Article 18(1), first subparagraph Article 18(1), second sentence Article 18(1), second subparagraph Article 18(1), third sentence Article 18(1), third subparagraph Article 18(2) to (6) Article 18(2) to (6) Article 19(1) to (5) Article 19(1) to (5) Article 19(6), first sentence Article 19(6), first subparagraph Article 19(6), second sentence Article 19(6), second subparagraph Article 20(1), (2) and (3) Article 20(1), (2) and (3) Article 20(4), first, second and third sentence Article 20(4), first subparagraph Article 20(4), fourth sentence Article 20(4), second subparagraph Article 20(5) Article 20(5) Articles 21 and 22 Articles 21 and 22 Article 22a Article 23 Article 23 Article 24 Article 24 Article 25 Annex I \u2014 Annex II \u2014 \u2014 Annex I \u2014 Annex II", "summary": "Anti-dumping measures Anti-dumping measures SUMMARY OF: Regulation (EU) 2016/1036 on protection against dumped imports from non-EU countries WHAT IS THE AIM OF THE REGULATION? Regulation (EU) 2016/1036 sets out the EU\u2019s trade defence rules to protect against imports from non-EU countries dumped on the EU market. It has been amended three times: by Regulation (EU) 2017/2321, by Regulation (EU) 2018/825 and by Delegated Regulation (EU) 2020/1173. KEY POINTS Regulation (EU) 2016/1036 lays down the following rules. Conditions Four conditions must be met before anti-dumping measures can be imposed on imports of a product: the imports must be dumped \u2014 if a product\u2019s export price to the EU is less than its normal value*; there must be material injury* to the EU industry producing the like product*; there must be a causal link between the dumped imports and the material injury; and the anti-dumping measure* must not be against the EU interest \u2014 the measures should not cause more harm to its overall economy than the relief brought to the industry suffering from the imports. Initiating a complaint An anti-dumping complaint is filed with the European Commission by or on behalf of the EU producers of the product concerned either directly or via the authorities of an EU country. Trade unions may also submit complaints jointly with the EU industry and become interested parties in the proceedings. In special circumstances, the Commission may also open an investigation into dumping on its own initiative. Any complaint must include evidence of dumping, injury and a causal link between the allegedly dumped imports and the alleged injury. To protect confidential business data, two versions of a complaint need to be lodged: a confidential version and a non-confidential version. The first will be available only to Commission staff directly working on the case. The non-confidential version will be accessible by all interested parties once the investigation is opened. The Commission must examine the accuracy and adequacy of the evidence provided in the complaint to determine whether there is a sufficient basis to justify initiating an investigation. This must be done within 45 days of the complaint being lodged. Anti-dumping investigation Once the Commission decides to launch an investigation, it must publish a notice in the Official Journal of the European Union. It contacts all known manufacturers and all other interested parties requesting them to complete questionnaires by a strict deadline. Where there are many potentially interested parties, the Commission may decide to carry out its investigation on the basis of a sample of operators (exporting producers, EU manufacturers, importers, users). Under the original Regulation (EU) 2016/1036, investigations could take 9 months before the Commission could impose provisional measures based on its provisional findings. A finding of dumping The following can take place where, based on its investigation, the Commission considers that dumping has occurred. Anti-dumping measures may be imposed on imports of the product concerned into the EU, which generally take the form of: an ad valoremduty \u2014 a percentage of the import value of the product concerned;specific duties \u2014 a fixed value for a certain amount of goods, e.g. \u20ac100 per tonne of a product; ora price undertaking \u2014 a commitment by an exporter to respect minimum import prices. Provisional measures, where the Commission imposes them, are for a maximum of 6 months. This may be followed by definitive measures which remain in force for 5 years. The duties are paid by the importer in the EU and collected by the national customs authorities of the EU countries concerned. Measures in force may be reviewed (interim review) under certain conditions. The scope of this review is usually limited to one or various elements of the initial measures, e.g. the level of dumping and/or injury, the product scope, or the form of the measures. After 5 years, the measures lapse unless an expiry review concludes that, if the measures were to expire, dumping and material injury would likely continue or recur. Importers may request a full or partial refund of duties paid if they can show that the dumping margin*, on the basis of which the duties were paid, has been eliminated or reduced. Amending Regulation (EU) 2017/2321 introduces a dumping calculation methodology to be used in cases concerning imports from World Trade Organization member countries where significant market distortions exist as a result of state intervention. Amending Regulation (EU) 2018/825 Among other things, the regulation does the following. It shortened the period of time for the imposition of provisional anti-dumping measures, if any, from 9 months after initiation to 7 months, with the possibility of extending the period to 8 months. It makes it easier for smaller businesses to participate in trade defence investigations (including a small and medium-sized enterprise (SME) trade defence helpdesk, creating a dedicated SME webpage and publishing a guide for SMEs). It amends how the rule known as the \u2018lesser duty rule\u2019 is applied in anti-dumping cases. The EU could previously only impose measures at a level lower than the full extent of the dumping, where a lower level (the \u2018injury margin\u2019) was sufficient to remove the injury suffered by the EU industry. Under the new rules, anti-dumping measures can be imposed at the full level of dumping where there is evidence of significant distortions in the exporting market for relevant raw materials used in the manufacture of the product concerned and provided this is in the interest of the EU as a whole to do so. It introduces new rules on calculating the \u2018non-injurious price\u2019 (the price that the industry is expected to have charged under normal circumstances). The calculation may now take into account the cost of necessary investments, for example, in infrastructure or research and development, but also future expenses related to social and environmental standards, for example under the EU\u2019s emission trading system. The non-injurious price now assumes a minimum profit of 6% that will be included in the calculation, with a higher profit margin possible on a case-by-case basis. It introduces a pre-disclosure period, during which interested parties received information on the imposition, or not, of provisional measures 3 weeks in advance with an obligation for the Commission to review, by 9 June 2020, whether a substantial rise in imports had occurred during the 3-week period of pre-disclosure and whether, if such a rise had occurred, it had caused additional injury to the EU industries concerned. It introduces the repayment of duties collected while an expiry review is ongoing if the review results in the termination of the measures. Delegated Regulation (EU) 2020/1173 In the review carried out in line with amending Regulation (EU) 2018/825, the Commission concluded that, overall, no additional injury to the EU industry had been caused by the imports during the pre-disclosure period. It therefore adopted a delegated act amending the duration of the period of pre-disclosure to 4 weeks. FROM WHEN DOES THE REGULATION APPLY? It has applied since 20 July 2016. Regulation (EU) 2016/1036 codified and replaced Regulation (EC) No 1225/2009 and its subsequent amendments. Amending Regulation (EU) 2017/2321 has applied since 20 December 2017. Amending Regulation (EU) 2018/825 has applied since 8 June 2018. Delegated Regulation (EU) 2020/1173 has applied since 11 August 2020. BACKGROUND For more information, see: Anti-dumping (European Commission) On the consequences of the COVID-19 outbreak on anti-dumping and anti-subsidy investigations. KEY TERMS Normal value: generally considered to be the market price for the product in the exporting country. However, if there are no sales, only a low volume of sales, or if sales are being made at a loss on the home market, the normal value of the product is usually calculated based on the cost of production in the exporting country plus a reasonable amount for selling, general and administrative costs, and profit. Specific rules exist for economies subject to significant distortions. Material injury: substantial injury to EU industry, e.g. loss of market share, reduced price levels and/or reduced profitability. Like product: a product which is identical to or closely resembles the imported product under consideration. Anti-dumping measures: measures imposed on imports of a product that are being sold at a price lower than the normal value of the product and which cause material injury to EU producers. Dumping margin: the difference between the normal value and the price that the same exporter charges for that product on the EU market (export price). MAIN DOCUMENT Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (codification) (OJ L 176, 30.6.2016, pp. 21-54) Successive amendments to Regulation (EU) 2016/1036 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (codification) (OJ L 176, 30.6.2016, pp. 55-91) See consolidated version. last update 16.10.2020"}
{"article": "30.6.2016 EN Official Journal of the European Union L 176/55 REGULATION (EU) 2016/1037 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (codification) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Council Regulation (EC) No 597/2009 (3) has been substantially amended (4). In the interests of clarity and rationality, that Regulation should be codified. (2) Annex 1A to the Agreement establishing the World Trade Organisation (\u2018the WTO Agreement\u2019) contains, inter alia, the General Agreement on Tariffs and Trade 1994 (\u2018the GATT 1994\u2019), an Agreement on Agriculture (\u2018the Agreement on Agriculture\u2019), an Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 1994 and an Agreement on Subsidies and Countervailing Measures (\u2018the Subsidies Agreement\u2019). (3) In order to ensure a proper and transparent application of the rules provided for in the Subsidies Agreement, the language of that agreement should be reflected in Union legislation to the best extent possible. (4) Furthermore, it is appropriate to explain, in adequate detail, when a subsidy is to be deemed to exist, according to which principles it is to be countervailable (in particular whether the subsidy has been granted specifically), and according to which criteria the amount of the countervailable subsidy is to be calculated. (5) In determining the existence of a subsidy, it is necessary to demonstrate that there has been a financial contribution by a government or a public body within the territory of a country, or that there has been some form of income or price support within the meaning of Article XVI of the GATT 1994, and that a benefit has thereby been conferred on the recipient enterprise. (6) For the calculation of the benefit to the recipient in cases where a market benchmark does not exist in the country concerned, the benchmark should be determined by adjusting the terms and conditions prevailing in the country concerned on the basis of actual factors available in that country. If this is not practicable because, inter alia, such prices or costs do not exist or are unreliable, then the appropriate benchmark should be determined by resorting to terms and conditions in other markets. (7) It is desirable to set out clear and detailed guidance as to the factors which may be relevant for the determination of whether the subsidised imports have caused material injury or are threatening to cause injury. In demonstrating that the volume and price levels of the imports concerned are responsible for injury sustained by a Union industry, attention should be given to the effect of other factors and in particular prevailing market conditions in the Union. (8) It is advisable to define the term \u2018Union industry\u2019 and to provide that parties related to exporters may be excluded from such an industry, and to define the term \u2018related\u2019. It is also necessary to provide for countervailing duty action to be taken on behalf of producers in a region of the Union and to set out guidelines on the definition of such a region. (9) It is necessary to specify who may lodge a countervailing duty complaint, including the extent to which it should be supported by the Union industry, and the information on countervailable subsidies, injury and causation which such a complaint should contain. It is also expedient to specify the procedures for the rejection of complaints or the initiation of proceedings. (10) It is necessary to specify the manner in which interested parties should be given notice of the information which the authorities require. Interested parties should have ample opportunity to present all relevant evidence and to defend their interests. It is also desirable to set out clearly the rules and procedures to be followed during the investigation, in particular the rules whereby interested parties are to make themselves known, present their views and submit information within specified time limits, if such views and information are to be taken into account. It is also appropriate to set out the conditions under which an interested party may have access to, and comment on, information presented by other interested parties. There should also be cooperation between the Member States and the Commission in the collection of information. (11) It is necessary to set out the conditions under which provisional duties may be imposed, including conditions whereby provisional duties may be imposed no earlier than 60 days from initiation and no later than nine months thereafter. Such duties may in all cases be imposed by the Commission only for a four-month period. (12) It is necessary to set out procedures for accepting undertakings which eliminate or offset the countervailable subsidies and injury instead of imposing provisional or definitive duties. It is also appropriate to specify the consequences of a breach or withdrawal of undertakings and that provisional duties may be imposed in cases of suspected violation or where further investigation is necessary to supplement the findings. In accepting undertakings, care should be taken that the proposed undertakings, and their enforcement, do not lead to anti-competitive behaviour. (13) It is appropriate to allow withdrawal of an undertaking and application of the duty by one single legal act. It is also necessary to ensure that the withdrawal procedure is terminated within a time limit of normally six months and in no case more than nine months in order to ensure the proper enforcement of the measure in force. (14) It is necessary to provide that the termination of cases should, irrespective of whether definitive measures are adopted or not, normally take place within 12 months, and in no case more than 13 months, of the initiation of the investigation. (15) Investigations or proceedings should be terminated where the amount of the subsidy is de minimis or, particularly in the case of imports originating in developing countries, the volume of subsidised imports or the injury is negligible, and it is appropriate to define those situations. Where measures are to be imposed, it is necessary to provide for the termination of investigations and to specify that measures should be less than the amount of countervailable subsidies if such lesser amount would remove the injury, and also to specify the method of calculating the level of measures in cases of sampling. (16) It is necessary to provide for retroactive collection of provisional duties if that is deemed appropriate and to define the circumstances which may trigger the retroactive application of duties to avoid the undermining of the definitive measures to be applied. It is also necessary to provide that duties may be applied retroactively in cases of breach or withdrawal of undertakings. (17) It is necessary to provide that measures are to lapse after five years unless a review indicates that they should be maintained. It is also necessary to provide, in cases where sufficient evidence is submitted of changed circumstances, for interim reviews or for investigations to determine whether refunds of countervailing duties are warranted. (18) Even though the Subsidies Agreement does not contain provisions concerning circumvention of countervailing measures, the possibility of such circumvention exists, in terms similar, albeit not identical, to the circumvention of anti-dumping measures. It is appropriate, therefore, to provide for an anti-circumvention provision in this Regulation. (19) It is desirable to clarify which parties have the right to request the initiation of anti-circumvention investigations. (20) It is also desirable to clarify which practices constitute circumvention of the measures in place. Circumvention practices may take place either inside or outside the Union. It is consequently necessary to provide that exemptions from the extended duties which may be granted to importers may also be granted to exporters when duties are being applied to address circumvention taking place outside the Union. (21) It is expedient to permit the suspension of countervailing measures where there is a temporary change in market conditions which makes the continued imposition of such measures temporarily inappropriate. (22) It is necessary to provide that imports under investigation may be made subject to registration upon importation in order to enable measures to be subsequently applied against such imports. (23) In order to ensure the proper enforcement of measures, it is necessary that Member States monitor, and report to the Commission on, the import trade of products subject to investigation or subject to measures, as well as the amount of duties collected under this Regulation. It is also necessary to provide for the possibility for the Commission to request Member States to supply, subject to confidentiality rules, information to be used for monitoring price undertakings and verifying the level of effectiveness of the measures in force. (24) It is expedient to provide for verification visits to check information submitted on countervailable subsidies and injury, such visits being, however, conditional on proper replies to questionnaires being received. (25) It is essential to provide for sampling in cases where the number of parties or transactions is large in order to permit completion of investigations within the appointed time limits. (26) It is necessary to provide that, where parties do not cooperate satisfactorily, other information may be used to establish findings and that such information may be less favourable to the parties than if they had cooperated. (27) Provision should be made for the treatment of confidential information so that business or governmental secrets are not divulged. (28) It is essential that provision be made for proper disclosure of the essential facts and considerations to parties which qualify for such treatment and that such disclosure be made, with due regard to the decision-making process in the Union, within a time \u2013limit which permits parties to defend their interests. (29) It is prudent to provide for an administrative system under which arguments can be presented as to whether measures are in the Union's interest, including consumers' interests, and to specify the time \u2013limits within which such information has to be presented, together with the disclosure rights of the parties concerned. (30) In applying the rules of the Subsidies Agreement it is essential, in order to maintain the balance of rights and obligations which that agreement seeks to establish, that the Union take account of the interpretation of those rights and obligations by the Union's major trading partners, as reflected in legislation or established practice. (31) The implementation of this Regulation requires uniform conditions for adopting provisional and definitive duties, and for the termination of an investigation without measures. Those measures should be adopted by the Commission in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (5). (32) The advisory procedure should be used for the adoption of provisional measures given the effects of such measures and their sequential logic in relation to the adoption of definitive measures. It should also be used for the acceptance of undertakings, initiation and non-initiation of expiry reviews, suspension of measures, extension of the suspension of measures and the reinstatement of measures given the effect of such measures as compared to definitive measures. Where a delay in the imposition of measures would cause injury which would be difficult to repair, it is necessary to allow the Commission to adopt immediately applicable provisional measures, HAVE ADOPTED THIS REGULATION: Article 1 Principles 1. A countervailing duty may be imposed to offset any subsidy granted, directly or indirectly, for the manufacture, production, export or transport of any product whose release for free circulation in the Union causes injury. 2. Notwithstanding paragraph 1, where products are not directly imported from the country of origin but are exported to the Union from an intermediate country, the provisions of this Regulation shall be fully applicable and the transaction or transactions shall, where appropriate, be regarded as having taken place between the country of origin and the Union. Article 2 Definitions For the purposes of this Regulation: (a) a product is considered to be subsidised if it benefits from a countervailable subsidy as defined in Articles 3 and 4. Such subsidy may be granted by the government of the country of origin of the imported product, or by the government of an intermediate country from which the product is exported to the Union, known for the purposes of this Regulation as \u2018the country of export\u2019; (b) \u2018government\u2019 means a government or any public body within the territory of the country of origin or export; (c) \u2018like product\u2019 means a product which is identical, that is to say, alike in all respects, to the product under consideration, or, in the absence of such a product, another product which, although not alike in all respects, has characteristics closely resembling those of the product under consideration; (d) \u2018injury\u2019, unless otherwise specified, means material injury to the Union industry, threat of material injury to the Union industry or material retardation of the establishment of such an industry, and shall be interpreted in accordance with the provisions of Article 8. Article 3 Definition of a subsidy A subsidy shall be deemed to exist if: 1. (a) there is a financial contribution by a government in the country of origin or export, that is to say, where: (i) a government practice involves a direct transfer of funds (for example, grants, loans, equity infusion), potential direct transfers of funds or liabilities (for example, loan guarantees); (ii) government revenue that is otherwise due is forgone or not collected (for example, fiscal incentives such as tax credits). In this regard, the exemption of an exported product from duties or taxes borne by the like product when destined for domestic consumption, or the remission of such duties or taxes in amounts not in excess of those which have been accrued, shall not be deemed to be a subsidy, provided that such an exemption is granted in accordance with the provisions of Annexes I, II and III; (iii) a government provides goods or services other than general infrastructure, or purchases goods; (iv) a government: \u2014 makes payments to a funding mechanism, or \u2014 entrusts or directs a private body to carry out one or more of the type of functions illustrated in points (i), (ii) and (iii) which would normally be vested in the government, and the practice, in no real sense, differs from practices normally followed by governments; or (b) there is any form of income or price support within the meaning of Article XVI of the GATT 1994; and 2. a benefit is thereby conferred. Article 4 Countervailable subsidies 1. Subsidies shall be subject to countervailing measures only if they are specific, as defined in paragraphs 2, 3 and 4. 2. In order to determine whether a subsidy is specific to an enterprise or industry or group of enterprises or industries (\u2018certain enterprises\u2019) within the jurisdiction of the granting authority, the following principles shall apply: (a) where the granting authority, or the legislation pursuant to which the granting authority operates, explicitly limits access to a subsidy to certain enterprises, such a subsidy shall be specific; (b) where the granting authority, or the legislation pursuant to which the granting authority operates, establishes objective criteria or conditions governing the eligibility for, and the amount of, a subsidy, specificity shall not exist, provided that the eligibility is automatic and that such criteria and conditions are strictly adhered to; (c) if, notwithstanding any appearance of non-specificity resulting from the application of the principles laid down in points (a) and (b), there are reasons to believe that the subsidy may in fact be specific, other factors may be considered. Such factors are: use of a subsidy programme by a limited number of certain enterprises; predominant use by certain enterprises; the granting of disproportionately large amounts of subsidy to certain enterprises; the manner in which discretion has been exercised by the granting authority in the decision to grant a subsidy. In this regard, information on the frequency with which applications for a subsidy are refused or approved and the reasons for such decisions shall, in particular, be considered. For the purpose of point (b), \u2018objective criteria or conditions\u2019 means criteria or conditions which are neutral, which do not favour certain enterprises over others, and which are economic in nature and horizontal in application, such as number of employees or size of enterprise. The criteria or conditions must be clearly set out by law, regulation, or other official document, so as to be capable of verification. In applying point (c) of the first subparagraph, account shall be taken of the extent of diversification of economic activities within the jurisdiction of the granting authority, as well as of the length of time during which the subsidy programme has been in operation. 3. A subsidy which is limited to certain enterprises located within a designated geographical region within the jurisdiction of the granting authority shall be specific. The setting or changing of generally applicable tax rates by all levels of government entitled to do so shall not be deemed to be a specific subsidy for the purposes of this Regulation. 4. Notwithstanding paragraphs 2 and 3, the following subsidies shall be deemed to be specific: (a) subsidies contingent, in law or in fact, whether solely or as one of several other conditions, upon export performance, including those illustrated in Annex I; (b) subsidies contingent, whether solely or as one of several other conditions, upon the use of domestic over imported goods. For the purposes of point (a), subsidies shall be considered to be contingent in fact upon export performance when the facts demonstrate that the granting of a subsidy, without having been made legally contingent upon export performance, is in fact tied to actual or anticipated exportation or export earnings. The mere fact that a subsidy is accorded to enterprises which export shall not, for that reason alone, be considered to be an export subsidy within the meaning of this provision. 5. Any determination of specificity under the provisions of this Article shall be clearly substantiated on the basis of positive evidence. Article 5 Calculation of the amount of the countervailable subsidy The amount of countervailable subsidies shall be calculated in terms of the benefit conferred on the recipient which is found to exist during the investigation period for subsidisation. Normally this period shall be the most recent accounting year of the beneficiary, but may be any other period of at least six months prior to the initiation of the investigation for which reliable financial and other relevant data are available. Article 6 Calculation of benefit to the recipient As regards the calculation of benefit to the recipient, the following rules shall apply: (a) government provision of equity capital shall not be considered to confer a benefit, unless the investment can be regarded as inconsistent with the usual investment practice, including for the provision of risk capital, of private investors in the territory of the country of origin and/or export; (b) a loan by a government shall not be considered to confer a benefit, unless there is a difference between the amount that the firm receiving the loan pays on the government loan and the amount that the firm would pay for a comparable commercial loan which the firm could actually obtain on the market. In that event the benefit shall be the difference between those two amounts; (c) a loan guarantee by a government shall not be considered to confer a benefit, unless there is a difference between the amount that the firm receiving the guarantee pays on a loan guaranteed by the government and the amount that the firm would pay for a comparable commercial loan in the absence of the government guarantee. In that case the benefit shall be the difference between those two amounts, adjusted for any differences in fees; (d) the provision of goods or services or purchase of goods by a government shall not be considered to confer a benefit, unless the provision is made for less than adequate remuneration or the purchase is made for more than adequate remuneration. The adequacy of remuneration shall be determined in relation to prevailing market conditions for the product or service in question in the country of provision or purchase, including price, quality, availability, marketability, transportation and other conditions of purchase or sale. If there are no such prevailing market terms and conditions for the product or service in question in the country of provision or purchase which can be used as appropriate benchmarks, the following rules shall apply: (i) the terms and conditions prevailing in the country concerned shall be adjusted, on the basis of actual costs, prices and other factors available in that country, by an appropriate amount which reflects normal market terms and conditions; or (ii) when appropriate, the terms and conditions prevailing in the market of another country or on the world market which are available to the recipient shall be used. Article 7 General provisions on calculation 1. The amount of the countervailable subsidies shall be determined per unit of the subsidised product exported to the Union. In establishing that amount, the following elements may be deducted from the total subsidy: (a) any application fee or other costs necessarily incurred in order to qualify for, or to obtain, the subsidy; (b) export taxes, duties or other charges levied on the export of the product to the Union specifically intended to offset the subsidy. Where an interested party claims a deduction, it must prove that the claim is justified. 2. Where the subsidy is not granted by reference to the quantities manufactured, produced, exported or transported, the amount of countervailable subsidy shall be determined by allocating the value of the total subsidy, as appropriate, over the level of production, sales or exports of the products concerned during the investigation period for subsidisation. 3. Where the subsidy can be linked to the acquisition or future acquisition of fixed assets, the amount of the countervailable subsidy shall be calculated by spreading the subsidy across a period which reflects the normal depreciation of such assets in the industry concerned. The amount so calculated which is attributable to the investigation period, including that which derives from fixed assets acquired before that period, shall be allocated as described in paragraph 2. Where the assets are non-depreciating, the subsidy shall be valued as an interest-free loan, and be treated in accordance with Article 6(b). 4. Where a subsidy cannot be linked to the acquisition of fixed assets, the amount of the benefit received during the investigation period shall in principle be attributed to that period, and allocated as described in paragraph 2, unless special circumstances arise justifying attribution over a different period. Article 8 Determination of injury 1. A determination of injury shall be based on positive evidence and shall involve an objective examination of: (a) the volume of the subsidised imports and the effect of the subsidised imports on prices in the Union market for like products; and (b) the consequent impact of those imports on the Union industry. 2. With regard to the volume of the subsidised imports, consideration shall be given to whether there has been a significant increase in subsidised imports, either in absolute terms or relative to production or consumption in the Union. With regard to the effect of the subsidised imports on prices, consideration shall be given to whether there has been significant price undercutting by the subsidised imports as compared with the price of a like product of the Union industry, or whether the effect of such imports is otherwise to depress prices to a significant degree or prevent price increases, which would otherwise have occurred, to a significant degree. No one or more of those factors can necessarily give decisive guidance. 3. Where imports of a product from more than one country are simultaneously subject to countervailing duty investigations, the effects of such imports shall be cumulatively assessed only if it is determined that: (a) the amount of countervailable subsidies established in relation to the imports from each country is more than de minimis as defined in Article 14(5) and the volume of imports from each country is not negligible; and (b) a cumulative assessment of the effects of the imports is appropriate in the light of the conditions of competition between imported products and the conditions of competition between the imported products and the like Union product. 4. The examination of the impact of the subsidised imports on the Union industry concerned shall include an evaluation of all relevant economic factors and indices having a bearing on the state of the industry, including the fact that an industry is still in the process of recovering from the effects of past subsidisation or dumping; the magnitude of the amount of countervailable subsidies; actual and potential decline in sales, profits, output, market share, productivity, return on investments and utilisation of capacity; factors affecting Union prices; actual and potential negative effects on cash flow, inventories, employment, wages, growth, ability to raise capital or investments and, in the case of agriculture, whether there has been an increased burden on government support programmes. This list is not exhaustive, nor can any one or more of these factors necessarily give decisive guidance. 5. It must be demonstrated, from all the relevant evidence presented in relation to paragraph 1, that the subsidised imports are causing injury. Specifically, that shall entail demonstrating that the volume and/or price levels identified pursuant to paragraph 2 are responsible for an impact on the Union industry as provided for in paragraph 4, and that that impact exists to a degree which enables it to be classified as material. 6. Known factors, other than the subsidised imports, which are injuring the Union industry at the same time shall also be examined to ensure that the injury caused by those other factors is not attributed to the subsidised imports pursuant to paragraph 5. Factors which may be considered in that respect shall include: the volume and prices of non-subsidised imports; contraction in demand or changes in the patterns of consumption; restrictive trade practices of, and competition between, third-country and Union producers; developments in technology; and the export performance and productivity of the Union industry. 7. The effect of the subsidised imports shall be assessed in relation to the production of the Union industry of the like product when available data permit the separate identification of that production on the basis of criteria such as the production process, producers' sales and profits. If such separate identification of that production is not possible, the effects of the subsidised imports shall be assessed by examination of the production of the narrowest group or range of products, including the like product, for which the necessary information can be provided. 8. A determination of a threat of material injury shall be based on facts and not merely on allegations, conjecture or remote possibility. The change in circumstances which would create a situation in which the subsidy would cause injury must have been clearly foreseen and must be imminent. In making a determination regarding the existence of a threat of material injury, consideration should be given to factors such as: (a) the nature of the subsidy or subsidies in question and the trade effects likely to arise therefrom; (b) a significant rate of increase of subsidised imports into the Union market indicating the likelihood of substantially increased imports; (c) whether there is sufficient freely disposable capacity on the part of the exporter or an imminent and substantial increase in such capacity indicating the likelihood of substantially increased subsidised exports to the Union, account being taken of the availability of other export markets to absorb any additional exports; (d) whether imports are entering at prices that would, to a significant degree, depress prices or prevent price increases which otherwise would have occurred, and would probably increase demand for further imports; (e) inventories of the product being investigated. No one of the factors listed above by itself can necessarily give decisive guidance, but the totality of the factors considered shall be such as to lead to the conclusion that further subsidised exports are imminent and that, unless protective action is taken, material injury will occur. Article 9 Definition of Union industry 1. For the purposes of this Regulation, the term \u2018Union industry\u2019 shall be interpreted as referring to the Union producers as a whole of the like products or to those of them whose collective output of the products constitutes a major proportion, as defined in Article 10(6), of the total Union production of those products, except that: (a) when producers are related to the exporters or importers, or are themselves importers of the allegedly subsidised product, the term \u2018Union industry\u2019 may be interpreted as referring to the rest of the producers; (b) in exceptional circumstances, the territory of the Union may, for the production in question, be divided into two or more competitive markets and the producers within each market may be regarded as a separate industry if: (i) the producers within such a market sell all or almost all of their production of the product in question in that market; and (ii) the demand in that market is not to any substantial degree met by producers of the product in question located elsewhere in the Union. In such circumstances, injury may be found to exist even where a major portion of the total Union industry is not injured, provided that there is a concentration of subsidised imports into such an isolated market and provided further that the subsidised imports are causing injury to the producers of all or almost all of the production within such a market. 2. For the purpose of paragraph 1, producers shall be considered to be related to exporters or importers only if: (a) one of them directly or indirectly controls the other; (b) both of them are directly or indirectly controlled by a third person; or (c) together they directly or indirectly control a third person, provided that there are grounds for believing or suspecting that the effect of the relationship is such as to cause the producer concerned to behave differently from non-related producers. For the purpose of this paragraph, one shall be deemed to control another when the former is legally or operationally in a position to exercise restraint or direction over the latter. 3. Where the Union industry has been interpreted as referring to the producers in a certain region, the exporters or the government granting countervailable subsidies shall be given an opportunity to offer undertakings pursuant to Article 13 in respect of the region concerned. In such cases, when evaluating the Union interest of the measures, special account shall be taken of the interest of the region. If an adequate undertaking is not offered promptly or if the situations set out in Article 13(9) and (10) apply, a provisional or definitive countervailing duty may be imposed in respect of the Union as a whole. In such cases the duties may, if practicable, be limited to specific producers or exporters. 4. The provisions of Article 8(7) shall be applicable to this Article. Article 10 Initiation of proceedings 1. Except as provided for in paragraph 8, an investigation to determine the existence, degree and effect of any alleged subsidy shall be initiated upon a written complaint by any natural or legal person, or any association not having legal personality, acting on behalf of the Union industry. The complaint may be submitted to the Commission or to a Member State, which shall forward it to the Commission. The Commission shall send Member States a copy of any complaint it receives. The complaint shall be deemed to have been lodged on the first working day following its delivery to the Commission by registered mail or the issuing of an acknowledgement of receipt by the Commission. Where, in the absence of any complaint, a Member State is in possession of sufficient evidence of subsidisation and of resultant injury to the Union industry, it shall immediately communicate such evidence to the Commission. 2. A complaint under paragraph 1 shall include sufficient evidence of the existence of countervailable subsidies (including, if possible, of their amount), injury and a causal link between the allegedly subsidised imports and the alleged injury. The complaint shall contain such information as is reasonably available to the complainant on the following: (a) the identity of the complainant and a description of the volume and value of the Union production of the like product by the complainant. Where a written complaint is made on behalf of the Union industry, the complaint shall identify the industry on behalf of which the complaint is made by a list of all known Union producers of the like product (or associations of Union producers of the like product) and, to the extent possible, a description of the volume and value of Union production of the like product accounted for by such producers; (b) a complete description of the allegedly subsidised product, the names of the country or countries of origin or export in question, the identity of each known exporter or foreign producer and a list of known persons importing the product in question; (c) evidence with regard to the existence, amount, nature and countervailability of the subsidies in question; (d) the changes in the volume of the allegedly subsidised imports, the effect of those imports on prices of the like product in the Union market and the consequent impact of the imports on the Union industry, as demonstrated by relevant factors and indices having a bearing on the state of the Union industry, such as those listed in Article 8(2) and (4). 3. The Commission shall, as far as possible, examine the accuracy and adequacy of the evidence provided in the complaint, to determine whether there is sufficient evidence to justify the initiation of an investigation. 4. An investigation may be initiated in order to determine whether or not the alleged subsidies are \u2018specific\u2019 within the meaning of Article 4(2) and (3). 5. An investigation may also be initiated in respect of measures of the type listed in Annex IV, to the extent that they contain an element of subsidy as defined by Article 3, in order to determine whether the measures in question fully conform to the provisions of that Annex. 6. An investigation shall not be initiated pursuant to paragraph 1 unless it has been determined, on the basis of an examination as to the degree of support for, or opposition to, the complaint expressed by Union producers of the like product, that the complaint has been made by, or on behalf of, the Union industry. The complaint shall be considered to have been made by, or on behalf of, the Union industry if it is supported by those Union producers whose collective output constitutes more than 50 % of the total production of the like product produced by that portion of the Union industry expressing either support for or opposition to the complaint. However, no investigation shall be initiated where Union producers expressly supporting the complaint account for less than 25 % of total production of the like product produced by the Union industry. 7. The authorities shall avoid, unless a decision has been taken to initiate an investigation, any publicising of the complaint seeking the initiation of an investigation. However, as soon as possible after receipt of a properly documented complaint pursuant to this Article, and in any event before the initiation of an investigation, the Commission shall notify the country of origin and/or export concerned, which shall be invited for consultations with the aim of clarifying the situation as to matters referred to in paragraph 2 and arriving at a mutually agreed solution. 8. If, in special circumstances, the Commission decides to initiate an investigation without having received a written complaint by, or on behalf of, the Union industry for the initiation of such an investigation, this shall be done on the basis of sufficient evidence of the existence of countervailable subsidies, injury and causal link, as described in paragraph 2, to justify such initiation. The Commission shall provide information to the Member States once it has determined the need to initiate such an investigation. 9. The evidence of both subsidies and injury shall be considered simultaneously in the decision on whether or not to initiate an investigation. A complaint shall be rejected where there is insufficient evidence of either countervailable subsidies or of injury to justify proceeding with the case. Proceedings shall not be initiated against countries whose imports represent a market share of below 1 %, unless such countries collectively account for 3 % or more of Union consumption. 10. The complaint may be withdrawn prior to initiation, in which case it shall be considered not to have been lodged. 11. Where it is apparent that there is sufficient evidence to justify initiating proceedings, the Commission shall do so within 45 days of the date on which the complaint was lodged and shall publish a notice in the Official Journal of the European Union. Where insufficient evidence has been presented, the complainant shall be so informed within 45 days of the date on which the complaint is lodged with the Commission. The Commission shall provide information to the Member States concerning its analysis of the complaint normally within 21 days of the date on which the complaint is lodged with the Commission. 12. The notice of initiation of the proceedings shall announce the initiation of an investigation, indicate the product and countries concerned, give a summary of the information received, and provide that all relevant information is to be communicated to the Commission. It shall state the periods within which interested parties may make themselves known, present their views in writing and submit information, if such views and information are to be taken into account during the investigation. It shall also state the period within which interested parties may apply to be heard by the Commission in accordance with Article 11(5). 13. The Commission shall advise the exporters, importers and representative associations of importers or exporters known to it to be concerned, as well as the country of origin and/or export and the complainants, of the initiation of the proceedings and, with due regard to the protection of confidential information, provide the full text of the written complaint referred to in paragraph 1 to the known exporters and to the authorities of the country of origin and/or export, and make it available upon request to other interested parties involved. Where the number of exporters involved is particularly high, the full text of the written complaint may instead be provided only to the authorities of the country of origin and/or export or to the relevant trade association. 14. A countervailing duty investigation shall not hinder the procedures of customs clearance. Article 11 The investigation 1. Following the initiation of proceedings, the Commission, acting in cooperation with the Member States, shall commence an investigation at Union level. Such an investigation shall cover both subsidisation and injury, and they shall be investigated simultaneously. For the purpose of a representative finding, an investigation period shall be selected which in the case of subsidisation shall, normally, cover the investigation period provided for in Article 5. Information relating to a period subsequent to the investigation period shall not, normally, be taken into account. 2. Parties receiving questionnaires used in a countervailing duty investigation shall be given at least 30 days to reply. The time limit for exporters shall be counted from the date of receipt of the questionnaire, which for this purpose shall be deemed to have been received one week from the day on which it was sent to the respondent or transmitted to the appropriate diplomatic representative of the country of origin and/or export. An extension to the 30-day period may be granted, due account being taken of the time limits of the investigation, provided that the party shows due cause for such an extension in terms of its particular circumstances. 3. The Commission may request Member States to supply information, and Member States shall take whatever steps are necessary in order to give effect to such requests. They shall send to the Commission the information requested together with the results of all inspections, checks or investigations carried out. Where that information is of general interest or where its transmission has been requested by a Member State, the Commission shall forward it to the Member States, provided that it is not confidential, in which case a non-confidential summary shall be forwarded. 4. The Commission may request Member States to carry out all necessary checks and inspections, particularly amongst importers, traders and Union producers, and to carry out investigations in third countries, provided that the firms concerned give their consent and that the government of the country in question has been officially notified and raises no objection. Member States shall take whatever steps are necessary in order to give effect to such requests from the Commission. Officials of the Commission shall be authorised, if the Commission or a Member State so requests, to assist the officials of Member States in carrying out their duties. 5. The interested parties which have made themselves known in accordance with the second subparagraph of Article 10(12), shall be heard if they have, within the period prescribed in the notice published in the Official Journal of the European Union, made a written request for a hearing showing that they are an interested party likely to be affected by the result of the proceedings and that there are particular reasons why they should be heard. 6. Opportunities shall, on request, be provided for the importers, exporters and the complainants, which have made themselves known in accordance with the second subparagraph of Article 10(12), and the government of the country of origin and/or export, to meet those parties having adverse interests, so that opposing views may be presented and rebuttal arguments offered. Provision of such opportunities shall take account of the need to preserve confidentiality and of the convenience to the parties. There shall be no obligation on any party to attend a meeting, and failure to do so shall not be prejudicial to that party's case. Oral information provided under this paragraph shall be taken into account by the Commission in so far as it is subsequently confirmed in writing. 7. The complainants, the government of the country of origin and/or export, importers and exporters and their representative associations, users and consumer organisations, which have made themselves known in accordance with the second subparagraph of Article 10(12), may, upon written request, inspect all information made available to the Commission by any party to an investigation, as distinct from internal documents prepared by the authorities of the Union or its Member States, which is relevant to the presentation of their cases and is not confidential within the meaning of Article 29, and is used in the investigation. Such parties may respond to such information and their comments shall be taken into consideration wherever they are sufficiently substantiated in the response. 8. Except in circumstances provided for in Article 28, the information which is supplied by interested parties and upon which findings are based shall be examined for accuracy as far as possible. 9. For proceedings initiated pursuant to Article 10(11), an investigation shall, whenever possible, be concluded within one year. In any event, such investigations shall in all cases be concluded within 13 months of their initiation, in accordance with the findings made pursuant to Article 13 for undertakings or the findings made pursuant to Article 15 for definitive action. 10. Throughout the investigation, the Commission shall afford the country of origin and/or export a reasonable opportunity to continue consultations with a view to clarifying the factual situation and arriving at a mutually agreed solution. Article 12 Provisional measures 1. Provisional duties may be imposed if: (a) proceedings have been initiated in accordance with Article 10; (b) a notice has been given to that effect and interested parties have been given an adequate opportunity to submit information and make comments in accordance with the second subparagraph of Article 10(12); (c) a provisional affirmative determination has been made that the imported product benefits from countervailable subsidies and of consequent injury to the Union industry; and (d) the Union interest calls for intervention to prevent such injury. The provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings. The amount of the provisional countervailing duty shall not exceed the total amount of countervailable subsidies as provisionally established, but it should be less than this amount if such lesser duty would be adequate to remove the injury to the Union industry. 2. Provisional duties shall be secured by a guarantee and the release of the products concerned for free circulation in the Union shall be conditional upon the provision of such a guarantee. 3. The Commission shall adopt provisional measures in accordance with the procedure referred to in Article 25(4). 4. Where a Member State requests immediate intervention by the Commission and where the conditions of the first and second subparagraphs of paragraph 1 are met, the Commission shall, within a maximum of five working days from receipt of the request, decide whether a provisional countervailing duty shall be imposed. 5. Provisional countervailing duties shall be imposed for a maximum period of four months. Article 13 Undertakings 1. On the condition that a provisional affirmative determination of subsidisation and injury has been made, the Commission may in accordance with the advisory procedure referred to in Article 25(2) accept satisfactory voluntary undertakings offers under which: (a) the country of origin and/or export agrees to eliminate or limit the subsidy or take other measures concerning its effects; or (b) any exporter undertakes to revise its prices or to cease exports to the area in question as long as such exports benefit from countervailable subsidies, so that the Commission is satisfied that the injurious effect of the subsidies is thereby eliminated. In such a case and as long as such undertakings are in force, the provisional duties imposed by the Commission in accordance with Article 12(3) and the definitive duties imposed in accordance with Article 15(1) shall not apply to the relevant imports of the product concerned manufactured by the companies referred to in the Commission decision accepting undertakings, as subsequently amended. Price increases under such undertakings shall not be higher than necessary to offset the amount of countervailable subsidies, and should be less than the amount of countervailable subsidies if such increases would be adequate to remove the injury to the Union industry. 2. Undertakings may be suggested by the Commission, but no country or exporter shall be obliged to enter into such an undertaking. The fact that countries or exporters do not offer such undertakings, or do not accept an invitation to do so, shall in no way prejudice consideration of the case. However, it may be determined that a threat of injury is more likely to be realised if the subsidised imports continue. Undertakings shall not be sought or accepted from countries or exporters unless a provisional affirmative determination of subsidisation and injury caused by such subsidisation has been made. Save in exceptional circumstances, undertakings may not be offered later than the end of the period during which representations may be made pursuant to Article 30(5). 3. Undertakings offered need not be accepted if their acceptance is considered impractical, such as where the number of actual or potential exporters is too great, or for other reasons, including reasons of general policy. The exporter and/or the country of origin and/or export concerned may be provided with the reasons for which it is proposed to reject the offer of an undertaking and may be given an opportunity to make comments thereon. The reasons for rejection shall be set out in the definitive decision. 4. Parties which offer an undertaking shall be required to provide a non-confidential version of that undertaking, so that it may be made available to interested parties to the investigation. 5. Where undertakings are accepted the investigation shall be terminated. The Commission shall terminate the investigation in accordance with the examination procedure referred to in Article 25(3). 6. If the undertakings are accepted, the investigation of subsidisation and injury shall normally be completed. In such a case, if a negative determination of subsidisation or injury is made, the undertaking shall automatically lapse, except in cases where such a determination is due in large part to the existence of an undertaking. In such cases, it may be required that an undertaking be maintained for a reasonable period. In the event that an affirmative determination of subsidisation and injury is made, the undertaking shall continue in accordance with its terms and the provisions of this Regulation. 7. The Commission shall require any country or exporter from whom undertakings have been accepted to provide, periodically, information relevant to the fulfilment of that undertaking, and to permit verification of pertinent data. Non-compliance with such requirements shall be construed as a breach of the undertaking. 8. Where undertakings are accepted from certain exporters during the course of an investigation, they shall, for the purpose of Articles 18, 19, 20 and 22, be deemed to take effect from the date on which the investigation is concluded for the country of origin and/or export. 9. In the case of breach or withdrawal of undertakings by any party to the undertaking, or in the case of withdrawal of acceptance of the undertaking by the Commission, the acceptance of the undertaking shall be withdrawn by the Commission, as appropriate, and the provisional duty which has been imposed by the Commission in accordance with Article 12 or the definitive duty which has been imposed in accordance with Article 15(1) shall apply, provided that the exporter concerned or the country of origin and/or export has, except in the case of withdrawal of the undertaking by that exporter or country, been given an opportunity to comment. The Commission shall provide information to the Member States when it decides to withdraw an undertaking. Any interested party or Member State may submit information, showing prima facie evidence of a breach of an undertaking. The subsequent assessment of whether or not a breach of an undertaking has occurred shall normally be concluded within six months, but in no case later than nine months following a duly substantiated request. The Commission may request the assistance of the competent authorities of the Member States in the monitoring of undertakings. 10. A provisional duty may be imposed in accordance with Article 12 on the basis of the best information available, where there is reason to believe that an undertaking is being breached, or in the case of breach or withdrawal of an undertaking, where the investigation which led to the undertaking has not been concluded. Article 14 Termination without measures 1. Where the complaint is withdrawn, proceedings may be terminated unless such termination would not be in the Union interest. 2. Where protective measures are unnecessary, the investigation or proceedings shall be terminated. The Commission shall terminate the investigation in accordance with the examination procedure referred to in Article 25(3). 3. There shall be immediate termination of the proceedings where it is determined that the amount of countervailable subsidies is de minimis, in accordance with paragraph 5, or where the volume of subsidised imports, actual or potential, or the injury, is negligible. 4. For proceedings initiated pursuant to Article 10(11), injury shall normally be regarded as negligible where the market share of the imports is less than the amounts set out in Article 10(9). With regard to investigations concerning imports from developing countries, the volume of subsidised imports shall also be considered negligible if it represents less than 4 % of the total imports of the like product in the Union, unless imports from developing countries whose individual shares of total imports represent less than 4 % collectively account for more than 9 % of the total imports of the like product in the Union. 5. The amount of the countervailable subsidies shall be considered to be de minimis if such amount is less than 1 % ad valorem, except where, as regards investigations concerning imports from developing countries, the de minimis threshold shall be 2 % ad valorem, provided that it is only the investigation that shall be terminated where the amount of the countervailable subsidies is below the relevant de minimis level for individual exporters, which shall remain subject to the proceedings and may be reinvestigated in any subsequent review carried out for the country concerned pursuant to Articles 18 and 19. Article 15 Imposition of definitive duties 1. Where the facts as finally established show the existence of countervailable subsidies and injury caused thereby, and the Union interest calls for intervention in accordance with Article 31, a definitive countervailing duty shall be imposed by the Commission acting in accordance with the examination procedure referred to in Article 25(3). Where provisional duties are in force, the Commission shall initiate that procedure no later than one month before the expiry of such duties. No measures shall be imposed if the subsidy or subsidies are withdrawn or it has been demonstrated that the subsidies no longer confer any benefit on the exporters involved. The amount of the countervailing duty shall not exceed the amount of countervailable subsidies established, but it should be less than the total amount of countervailable subsidies if such lesser duty would be adequate to remove the injury to the Union industry. 2. A countervailing duty shall be imposed in the appropriate amounts in each case, on a non-discriminatory basis, on imports of a product from all sources found to benefit from countervailable subsidies and causing injury, except for imports from those sources from which undertakings under the terms of this Regulation have been accepted. The Regulation imposing the duty shall specify the duty for each supplier, or, if that is impracticable, the supplying country concerned. 3. When the Commission has limited its investigation in accordance with Article 27, any countervailing duty applied to imports from exporters or producers which have made themselves known in accordance with Article 27 but were not included in the investigation shall not exceed the weighted average amount of countervailable subsidies established for the parties in the sample. For the purpose of this paragraph, the Commission shall disregard any zero and de minimis amounts of countervailable subsidies and amounts of countervailable subsidies established in the circumstances referred to in Article 28. Individual duties shall be applied to imports from any exporter or producer for which an individual amount of subsidisation has been calculated as provided for in Article 27. Article 16 Retroactivity 1. Provisional measures and definitive countervailing duties shall only be applied to products which enter free circulation after the time when the measure taken pursuant to Article 12(1) or Article 15(1), as the case may be, enters into force, subject to the exceptions set out in this Regulation. 2. Where a provisional duty has been applied and the facts as finally established show the existence of countervailable subsidies and injury, the Commission shall decide, irrespective of whether a definitive countervailing duty is to be imposed, what proportion of the provisional duty is to be definitively collected. For that purpose, \u2018injury\u2019 shall not include material delay of the establishment of a Union industry, nor threat of material injury, except where it is found that this would, in the absence of provisional measures, have developed into material injury. In all other cases involving such threat or delay, any provisional amounts shall be released and definitive duties can only be imposed from the date on which a final determination of threat or material delay is made. 3. If the definitive countervailing duty is higher than the provisional duty, the difference shall not be collected. If the definitive duty is lower than the provisional duty, the duty shall be recalculated. Where a final determination is negative, the provisional duty shall not be confirmed. 4. A definitive countervailing duty may be levied on products which were entered for consumption no more than 90 days prior to the date of application of provisional measures but not prior to the initiation of the investigation, provided that: (a) the imports have been registered in accordance with Article 24(5); (b) the importers concerned have been given an opportunity to comment by the Commission; (c) there are critical circumstances where for the subsidised product in question injury which is difficult to repair is caused by massive imports in a relatively short period of a product benefiting from countervailable subsidies under the terms of this Regulation; and (d) it is deemed necessary, in order to preclude the recurrence of such injury, to assess countervailing duties retroactively on those imports. 5. In cases of breach or withdrawal of undertakings, definitive duties may be levied on goods entered for free circulation no more than 90 days before the application of provisional measures, provided that the imports have been registered in accordance with Article 24(5) and that any such retroactive assessment shall not apply to imports entered before the breach or withdrawal of the undertaking. Article 17 Duration A countervailing measure shall remain in force only as long as, and to the extent that, it is necessary to counteract the countervailable subsidies which are causing injury. Article 18 Expiry reviews 1. A definitive countervailing measure shall expire five years from its imposition or five years from the date of the most recent review which has covered both subsidisation and injury, unless it is determined in a review that the expiry would be likely to lead to a continuation or recurrence of subsidisation and injury. Such an expiry review shall be initiated on the initiative of the Commission, or upon a request made by or on behalf of Union producers, and the measure shall remain in force pending the outcome of that review. 2. An expiry review shall be initiated where the request contains sufficient evidence that the expiry of the measures would be likely to result in a continuation or recurrence of subsidisation and injury. Such a likelihood may, for example, be indicated by evidence of continued subsidisation and injury or evidence that the removal of injury is partly or solely due to the existence of measures or evidence that the circumstances of the exporters, or market conditions, are such that they would indicate the likelihood of further injurious subsidisation. 3. In carrying out investigations under this Article, the exporters, importers, the country of origin and/or export and the Union producers shall be provided with the opportunity to amplify, rebut or comment on the matters set out in the review request, and conclusions shall be reached with due account taken of all relevant and duly documented evidence presented in relation to the question as to whether the expiry of measures would be likely, or unlikely, to lead to the continuation or recurrence of subsidisation and injury. 4. A notice of impending expiry shall be published in the Official Journal of the European Union at an appropriate time in the final year of the period of application of the measures as defined in this Article. Thereafter, the Union producers shall, no later than three months before the end of the five-year period, be entitled to lodge a review request in accordance with paragraph 2. A notice announcing the actual expiry of measures under this Article shall also be published. Article 19 Interim reviews 1. The need for the continued imposition of measures may also be reviewed, where warranted, on the initiative of the Commission or at the request of a Member State or, provided that a reasonable period of time of at least one year has elapsed since the imposition of the definitive measure, upon a request by any exporter, importer or by the Union producers or the country of origin and/or export which contains sufficient evidence substantiating the need for such an interim review. 2. An interim review shall be initiated where the request contains sufficient evidence that the continued imposition of the measure is no longer necessary to offset the countervailable subsidy and/or that the injury would be unlikely to continue or recur if the measure were removed or varied, or that the existing measure is not, or is no longer, sufficient to counteract the countervailable subsidy which is causing injury. 3. Where the countervailing duties imposed are less than the amount of countervailable subsidies found, an interim review may be initiated if the Union producers or any other interested party submit, normally within two years from the entry into force of the measures, sufficient evidence that, after the original investigation period and prior to or following the imposition of measures, export prices have decreased or that there has been no movement, or insufficient movement of resale prices of the imported product in the Union. If the investigation proves the allegations to be correct, countervailing duties may be increased to achieve the price increase required to remove injury. However, the increased duty level shall not exceed the amount of the countervailable subsidies. The interim review may also be initiated, under the conditions set out above, at the initiative of the Commission or at the request of a Member State. 4. In carrying out investigations pursuant to this Article, the Commission may, inter alia, consider whether the circumstances with regard to subsidisation and injury have changed significantly, or whether existing measures are achieving the intended results in removing the injury previously determined under Article 8. In those respects, account shall be taken in the final determination of all relevant and duly documented evidence. Article 20 Accelerated reviews Any exporter whose exports are subject to a definitive countervailing duty but which was not individually investigated during the original investigation for reasons other than a refusal to cooperate with the Commission, shall be entitled, upon request, to an accelerated review in order that the Commission may promptly establish an individual countervailing duty rate for that exporter. Such a review shall be initiated after Union producers have been given an opportunity to comment. Article 21 Refunds 1. Notwithstanding Article 18, an importer may request reimbursement of duties collected where it is shown that the amount of countervailable subsidies, on the basis of which duties were paid, has been either eliminated or reduced to a level which is below the level of the duty in force. 2. In requesting a refund of countervailing duties, the importer shall submit an application to the Commission. The application shall be submitted via the Member State in the territory of which the products were released for free circulation, within six months of the date on which the amount of the definitive duties to be levied was duly determined by the competent authorities or of the date on which a decision was made definitively to collect the amounts secured by way of provisional duty. Member States shall forward the request to the Commission forthwith. 3. An application for refund shall be considered to be duly supported by evidence only where it contains precise information on the amount of refund of countervailing duties claimed and all customs documentation relating to the calculation and payment of such amount. It shall also include evidence, for a representative period, of the amount of countervailable subsidies for the exporter or producer to which the duty applies. In cases where the importer is not associated with the exporter or producer concerned and such information is not immediately available, or where the exporter or producer is unwilling to release it to the importer, the application shall contain a statement from the exporter or producer that the amount of countervailable subsidies has been reduced or eliminated, as specified in this Article, and that the relevant supporting evidence will be provided to the Commission. Where such evidence is not forthcoming from the exporter or producer within a reasonable period of time the application shall be rejected. 4. The Commission shall decide whether and to what extent the application should be granted, or it may decide at any time to initiate an interim review, whereupon the information and findings from such a review, carried out in accordance with the provisions applicable for such reviews, shall be used to determine whether and to what extent a refund is justified. Refunds of duties shall normally take place within 12 months and in no circumstances more than 18 months after the date on which a request for a refund, duly supported by evidence, has been made by an importer of the product subject to the countervailing duty. The payment of any refund authorised should normally be made by Member States within 90 days of the decision referred to in the first subparagraph. Article 22 General provisions on reviews and refunds 1. The relevant provisions of this Regulation with regard to procedures and the conduct of investigations, excluding those relating to time limits, shall apply to any review carried out pursuant to Articles 18, 19 and 20. Reviews carried out pursuant to Articles 18 and 19 shall be carried out expeditiously and shall normally be concluded within 12 months of the date of initiation of the review. In any event, reviews pursuant to Articles 18 and 19 shall in all cases be concluded within 15 months of initiation. Reviews pursuant to Article 20 shall in all cases be concluded within nine months of the date of initiation. If a review carried out pursuant to Article 18 is initiated while a review under Article 19 is ongoing in the same proceedings, the review pursuant to Article 19 shall be concluded at the same time as provided for above for the review pursuant to Article 18. If the investigation is not completed within the deadlines specified in the second, third and fourth subparagraphs, the measures shall: (a) expire in investigations pursuant to Article 18; (b) expire in the case of investigations carried out pursuant to Articles 18 and 19 in parallel, where either the investigation pursuant to Article 18 was initiated while a review under Article 19 was ongoing in the same proceedings or where such reviews were initiated at the same time; or (c) remain unchanged in investigations pursuant to Articles 19 and 20. A notice announcing the actual expiry or maintenance of the measures pursuant to this paragraph shall be published in the Official Journal of the European Union. 2. Reviews pursuant to Articles 18, 19 and 20 shall be initiated by the Commission. The Commission shall decide whether or not to initiate reviews pursuant to Article 18 in accordance with the advisory procedure referred to in Article 25(2). The Commission shall also provide information to the Member States once an operator or a Member State has submitted a request justifying the initiation of a review pursuant to Articles 19 and 20 and the Commission has completed its analysis thereof, or once the Commission has itself determined that the need for the continued imposition of measures should be reviewed. 3. Where warranted by reviews, measures shall, in accordance with the examination procedure referred to in Article 25(3), be repealed or maintained pursuant to Article 18, or repealed, maintained or amended pursuant to Articles 19 and 20. 4. Where measures are repealed for individual exporters, but not for the country as a whole, such exporters shall remain subject to the proceedings and may be reinvestigated in any subsequent review carried out for that country pursuant to this Article. 5. Where a review of measures pursuant to Article 19 is in progress at the end of the period of application of measures as defined in Article 18, the measures shall also be investigated under the provisions of Article 18. 6. In all review or refund investigations carried out pursuant to Articles 18 to 21, the Commission shall, provided that circumstances have not changed, apply the same methodology as in the investigation which led to the duty, with due account being taken of Articles 5, 6, 7 and 27. Article 23 Circumvention 1. Countervailing duties imposed pursuant to this Regulation may be extended to imports from third countries of the like product, whether slightly modified or not, or to imports of the slightly modified like product from the country subject to measures, or parts thereof, when circumvention of the measures in force is taking place. 2. Countervailing duties not exceeding the residual countervailing duty imposed in accordance with Article 15(2) may be extended to imports from companies benefiting from individual duties in the countries subject to measures when circumvention of the measures in force is taking place. 3. Circumvention shall be defined as a change in the pattern of trade between third countries and the Union or between individual companies in the country subject to measures and the Union, which stems from a practice, process or work for which there is insufficient due cause or economic justification other than the imposition of the duty, and where there is evidence of injury or that the remedial effects of the duty are being undermined in terms of the prices and/or quantities of the like product and that the imported like product and/or parts thereof still benefit from the subsidy. The practice, process or work referred to in the first subparagraph includes, inter alia: (a) the slight modification of the product concerned to make it fall under customs codes which are normally not subject to the measures, provided that the modification does not alter its essential characteristics; (b) the consignment of the product subject to measures via third countries; (c) the reorganisation by exporters or producers of their patterns and channels of sales in the country subject to measures in order to eventually have their products exported to the Union through producers benefiting from an individual duty rate lower than that applicable to the products of the manufacturers. 4. Investigations shall be initiated pursuant to this Article on the initiative of the Commission or at the request of a Member State or of any interested party on the basis of sufficient evidence regarding the factors set out in paragraphs 1, 2 and 3. Initiations shall be made by Commission Regulation which may also instruct customs authorities to subject imports to registration in accordance with Article 24(5) or to request guarantees. The Commission shall provide information to the Member States once an interested party or a Member State has submitted a request justifying the initiation of an investigation and the Commission has completed its analysis thereof, or where the Commission has itself determined that there is a need to initiate an investigation. Investigations shall be carried out by the Commission. The Commission may be assisted by customs authorities and the investigations shall be concluded within nine months. Where the facts as finally ascertained justify the extension of measures, this shall be done by the Commission acting in accordance with the examination procedure referred to in Article 25(3). The extension shall take effect from the date on which registration was imposed pursuant to Article 24(5) or on which guarantees were requested. The relevant procedural provisions of this Regulation with regard to the initiation and the conduct of investigations shall apply pursuant to this Article. 5. Imports shall not be subject to registration pursuant to Article 24(5) or measures where they are traded by companies which benefit from exemptions. 6. Requests for exemptions duly supported by evidence shall be submitted within the time limits established in the Commission Regulation initiating the investigation. Where the circumventing practice, process or work takes place outside the Union, exemptions may be granted to producers of the product concerned that can show that they are not related to any producer subject to the measures and that are found not to be engaged in circumvention practices as defined in paragraph 3. Where the circumventing practice, process or work takes place inside the Union, exemptions may be granted to importers that can show that they are not related to producers subject to the measures. Those exemptions shall be granted by decision of the Commission and shall remain valid for the period and under the conditions set down therein. The Commission shall provide information to the Member States once it has concluded its analysis. Provided that the conditions set in Article 20 are met, exemptions may also be granted after the conclusion of the investigation leading to the extension of the measures. 7. Provided that at least one year has lapsed from the extension of the measures, and in case the number of parties requesting or potentially requesting an exemption is significant, the Commission may decide to initiate a review of the extension of the measures. Any such review shall be conducted in accordance with the provisions of Article 22(1) as applicable to reviews under Article 19. 8. Nothing in this Article shall preclude the normal application of the provisions in force concerning customs duties. Article 24 General provisions 1. Provisional or definitive countervailing duties shall be imposed by Regulation, and collected by Member States in the form, at the rate specified and according to the other criteria laid down in the Regulation imposing such duties. Such duties shall also be collected independently of the customs duties, taxes and other charges normally imposed on imports. No product shall be subject to both anti-dumping and countervailing duties for the purpose of dealing with one and the same situation arising from dumping or from export subsidisation. 2. Regulations imposing provisional or definitive countervailing duties, and Regulations or Decisions accepting undertakings or terminating investigations or proceedings, shall be published in the Official Journal of the European Union. Such Regulations or Decisions shall contain in particular, and with due regard to the protection of confidential information, the names of the exporters, if possible, or of the countries involved, a description of the product and a summary of the facts and considerations relevant to the subsidy and injury determinations. In each case, a copy of the Regulation or Decision shall be sent to known interested parties. The provisions of this paragraph shall apply mutatis mutandis to reviews. 3. Special provisions, in particular with regard to the common definition of the concept of origin, as contained in Regulation (EU) No 952/2013 of the European Parliament and of the Council (6), may be adopted pursuant to this Regulation. 4. In the Union interest, measures imposed pursuant to this Regulation may be suspended by a decision of the Commission in accordance with the advisory procedure referred to in Article 25(2) for a period of nine months. The suspension may be extended for a further period, not exceeding one year, by the Commission acting in accordance with the advisory procedure referred to in Article 25(2). Measures may only be suspended where market conditions have temporarily changed to an extent that injury would be unlikely to resume as a result of the suspension, and provided that the Union industry has been given an opportunity to comment and those comments have been taken into account. Measures may at any time be reinstated in accordance with the advisory procedure referred to in Article 25(2) if the reason for suspension is no longer applicable. 5. The Commission may, after having informed the Member States in due time, direct the customs authorities to take the appropriate steps to register imports, so that measures may subsequently be applied against those imports from the date of such registration. Imports may be made subject to registration following a request from the Union industry which contains sufficient evidence to justify such action. Registration shall be introduced by Regulation which shall specify the purpose of the action and, if appropriate, the estimated amount of possible future liability. Imports shall not be made subject to registration for a period longer than nine months. 6. Member States shall report to the Commission every month on the import trade of products subject to investigation and to measures, and on the amount of duties collected pursuant to this Regulation. 7. Without prejudice to paragraph 6, the Commission may request Member States, on a case-by-case basis, to supply information necessary to monitor efficiently the application of measures. In this respect, the provisions of Articles 11(3) and (4) shall apply. Any data submitted by Member States pursuant to this Article shall be covered by the provisions of Article 29(6). Article 25 Committee procedure 1. The Commission shall be assisted by the Committee established by Regulation (EU) 2016/1036 of the European Parliament and of the Council (7). That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 thereof, shall apply. 5. Pursuant to Article 3(5) of Regulation (EU) No 182/2011, where the written procedure is used to adopt definitive measures pursuant to paragraph 3 of this Article, or to decide on the initiation or non-initiation of expiry reviews pursuant to Article 18 of this Regulation, that procedure shall be terminated without result where, within the time limit set down by the chair, the chair so decides or a majority of committee members as defined in Article 5(1) of Regulation (EU) No 182/2011 so request. Where the written procedure is used in other instances where there has been a discussion of the draft measure in the committee, that procedure shall be terminated without result where, within the time limit set down by the chair, the chair so decides or a simple majority of committee members so request. Where the written procedure is used in other instances where there has not been a discussion of the draft measure in the committee, that procedure shall be terminated without result where, within the time limit set down by the chair, the chair so decides or at least a quarter of committee members so request. 6. The committee may consider any matter relating to the application of this Regulation, raised by the Commission or at the request of a Member State. Member States may request information and may exchange views in the committee or directly with the Commission. Article 26 Verification visits 1. The Commission shall, where it considers it appropriate, carry out visits to examine the records of importers, exporters, traders, agents, producers, trade associations and organisations, and to verify information provided on subsidisation and injury. In the absence of a proper and timely reply the Commission may choose not to carry out a verification visit. 2. The Commission may carry out investigations in third countries as required, provided that it obtains the agreement of the firms concerned, that it notifies the country in question and that the latter does not object to the investigation. As soon as the agreement of the firms concerned has been obtained, the Commission shall notify the country of origin and/or export of the names and addresses of the firms to be visited and the dates agreed. 3. The firms concerned shall be advised of the nature of the information to be verified during verification visits and of any further information which needs to be provided during such visits, though this does not preclude requests, made during the verification, for further details to be provided in the light of information obtained. 4. In investigations carried out pursuant to paragraphs 1, 2 and 3, the Commission shall be assisted by officials of those Member States which so request. Article 27 Sampling 1. In cases where the number of complainants, exporters or importers, types of product or transactions is large, the investigation may be limited to: (a) a reasonable number of parties, products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection; or (b) the largest representative volume of the production, sales or exports which can reasonably be investigated within the time available. 2. The final selection of parties, types of products or transactions made under this Article shall rest with the Commission, though preference shall be given to choosing a sample in consultation with, and with the consent of, the parties concerned, provided that such parties make themselves known and make sufficient information available, within three weeks of initiation of the investigation, to enable a representative sample to be chosen. 3. In cases where the investigation has been limited in accordance with this Article, an individual amount of countervailable subsidisation shall be calculated for any exporter or producer not initially selected who submits the necessary information within the time limits provided for in this Regulation, except where the number of exporters or producers is so large that individual examinations would be unduly burdensome and would prevent completion of the investigation in good time. 4. Where it is decided to sample and there is a degree of non-cooperation by some or all of the parties selected which is likely to materially affect the outcome of the investigation, a new sample may be selected. However, if a material degree of non-cooperation persists or there is insufficient time to select a new sample, the relevant provisions of Article 28 shall apply. Article 28 Non-cooperation 1. In cases in which any interested party refuses access to, or otherwise does not provide necessary information within the time limits provided for in this Regulation, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made on the basis of the facts available. Where it is found that any interested party has supplied false or misleading information, that information shall be disregarded and use may be made of the facts available. Interested parties shall be made aware of the consequences of non-cooperation. 2. Failure to give a computerised response shall not be deemed to constitute non-cooperation, provided that the interested party shows that presenting the response as requested would result in an unreasonable extra burden or unreasonable additional cost. 3. Where the information submitted by an interested party is not ideal in all respects, it shall nevertheless not be disregarded, provided that any deficiencies are not such as to cause undue difficulty in arriving at a reasonably accurate finding and that the information is appropriately submitted in good time and is verifiable, and that the party has acted to the best of its ability. 4. If evidence or information is not accepted, the supplying party shall be informed forthwith of the reasons therefor and shall be granted an opportunity to provide further explanations within the time limit specified. If the explanations are considered unsatisfactory, the reasons for rejection of such evidence or information shall be disclosed and given in published findings. 5. If determinations, including those regarding the amount of countervailable subsidies, are based on the provisions of paragraph 1, including the information supplied in the complaint, it shall, where practicable and with due regard to the time limits of the investigation, be checked by reference to information from other independent sources which may be available, such as published price lists, official import statistics and customs returns, or information obtained from other interested parties during the investigation. Such information may include relevant data pertaining to the world market or other representative markets, where appropriate. 6. If an interested party does not cooperate, or cooperates only partially, so that relevant information is thereby withheld, the result of the investigation may be less favourable to the party than if it had cooperated. Article 29 Confidentiality 1. Any information which is by nature confidential (for example, because its disclosure would be of significant competitive advantage to a competitor or would have a significantly adverse effect upon a person supplying the information or upon a person from whom the person supplying the information has acquired the information), or which is provided on a confidential basis by parties to an investigation shall, if good cause is shown, be treated as such by the authorities. 2. Interested parties providing confidential information shall be required to provide non-confidential summaries thereof. Those summaries shall be in sufficient detail to permit a reasonable understanding of the substance of the information submitted in confidence. In exceptional circumstances, such parties may indicate that such information is not capable of being summarised. In such exceptional circumstances, a statement of the reasons why summarisation is not possible shall be provided. 3. If it is considered that a request for confidentiality is not warranted and if the supplier of the information is either unwilling to make the information available or to authorise its disclosure in generalised or summary form, such information may be disregarded unless it can be satisfactorily demonstrated from appropriate sources that the information is correct. Requests for confidentiality shall not be arbitrarily rejected. 4. This Article shall not preclude the disclosure of general information by the Union authorities, and, in particular, of the reasons on which decisions taken pursuant to this Regulation are based, or disclosure of the evidence relied on by the Union authorities in so far as is necessary to explain those reasons in court proceedings. Such disclosure shall take into account the legitimate interests of the parties concerned that their business or governmental secrets not be divulged. 5. The Commission and the Member States, including the officials of either, shall not reveal any information received pursuant to this Regulation for which confidential treatment has been requested by its supplier, without specific permission from that supplier. Exchanges of information between the Commission and Member States, or any internal documents prepared by the authorities of the Union or the Member States, shall not be divulged except as specifically provided for in this Regulation. 6. Information received pursuant to this Regulation shall be used only for the purpose for which it was requested. This provision shall not preclude the use of information received in the context of one investigation for the purpose of initiating other investigations within the same proceedings concerning the same like product. Article 30 Disclosure 1. The complainants, importers and exporters and their representative associations, and the country of origin and/or export, may request disclosure of the details underlying the essential facts and considerations on the basis of which provisional measures have been imposed. Requests for such disclosure shall be made in writing immediately following the imposition of provisional measures, and the disclosure shall be made in writing as soon as possible thereafter. 2. The parties mentioned in paragraph 1 may request final disclosure of the essential facts and considerations on the basis of which it is intended to recommend the imposition of definitive measures, or the termination of an investigation or proceedings without the imposition of measures, particular attention being paid to the disclosure of any facts or considerations which are different from those used for any provisional measures. 3. Requests for final disclosure shall be addressed to the Commission in writing and be received, in cases where a provisional duty has been imposed, no later than one month after publication of the imposition of that duty. Where a provisional duty has not been imposed, parties shall be provided with an opportunity to request final disclosure within time limits set by the Commission. 4. Final disclosure shall be given in writing. It shall be made, due regard being had to the protection of confidential information, as soon as possible and, normally, no later than one month prior to the initiation of the procedures set out in Article 14 or Article 15. Where the Commission is not in a position to disclose certain facts or considerations at that time, they shall be disclosed as soon as possible thereafter. Disclosure shall not prejudice any subsequent decision which may be taken by the Commission, but where such a decision is based on any different facts and considerations they shall be disclosed as soon as possible. 5. Representations made after final disclosure is given shall be taken into consideration only if received within a period to be set by the Commission in each case, which shall be at least 10 days, due consideration being given to the urgency of the matter. A shorter period may be set whenever an additional final disclosure has to be made. Article 31 Union interest 1. A determination as to whether the Union's interest calls for intervention shall be based on an appraisal of all the various interests taken as a whole, including the interests of the domestic industry and users and consumers. A determination pursuant to this Article shall be made only where all parties have been given the opportunity to make their views known pursuant to paragraph 2. In such an examination, the need to eliminate the trade-distorting effects of injurious subsidisation and to restore effective competition shall be given special consideration. Measures, as determined on the basis of subsidisation and injury found, may not be applied where the authorities, on the basis of all the information submitted, can clearly conclude that it is not in the Union's interest to apply such measures. 2. In order to provide a sound basis on which the authorities can take account of all views and information in the decision as to whether or not the imposition of measures is in the Union's interest, the complainants, importers and their representative associations, representative users and representative consumer organisations may, within the time limits specified in the notice of initiation of the countervailing duty investigation, make themselves known and provide information to the Commission. Such information, or appropriate summaries thereof, shall be made available to the other parties specified in this paragraph, and they shall be entitled to respond to such information. 3. The parties which have acted in accordance with paragraph 2 may request a hearing. Such requests shall be granted when they are submitted within the time limits set in paragraph 2, and when they set out the reasons, in terms of the Union interest, why the parties should be heard. 4. The parties which have acted in accordance with paragraph 2 may provide comments on the application of any provisional duties. Such comments shall be received within 25 days of the date of application of such measures if they are to be taken into account and they, or appropriate summaries thereof, shall be made available to other parties who shall be entitled to respond to such comments. 5. The Commission shall examine the information which is properly submitted and the extent to which it is representative, and the results of such analysis, together with an opinion on its merits, shall be transmitted to the committee referred to in Article 25 as part of the draft measure submitted pursuant to Articles 14 and 15. The views expressed in the committee should be taken into account by the Commission under the conditions provided for in Regulation (EU) No 182/2011. 6. The parties which have acted in conformity with paragraph 2 may request that the facts and considerations on which final decisions are likely to be taken be made available to them. Such information shall be made available to the extent possible and without prejudice to any subsequent decision taken by the Commission. 7. Information shall be taken into account only where it is supported by actual evidence which substantiates its validity. Article 32 Relationships between countervailing duty measures and multilateral remedies If an imported product is made subject to any countermeasures imposed following recourse to the dispute settlement procedures of the Subsidies Agreement, and such measures are appropriate to remove the injury caused by the countervailable subsidies, any countervailing duty imposed with regard to that product shall immediately be suspended, or repealed, as appropriate. Article 33 Final provisions This Regulation shall not preclude the application of: (a) any special rules laid down in agreements concluded between the Union and third countries; (b) the Union Regulations in the agricultural sector and Council Regulations (EC) No 1667/2006 (8), (EC) No 614/2009 (9) and (EC) No 1216/2009 (10). This Regulation shall operate by way of complement to those Regulations and in derogation from any provisions thereof which preclude the application of countervailing duties; (c) special measures, provided that such action does not run counter to obligations under the GATT 1994. Article 34 Report The Commission shall include information on the implementation of this Regulation in its annual report on the application and implementation of trade defence measures presented to the European Parliament and to the Council pursuant to Article 23 of Regulation (EU) 2016/1036. Article 35 Repeal Regulation (EC) No 597/2009 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI. Article 36 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 8 June 2016. For the European Parliament The President M. SCHULZ For the Council The President A.G. KOENDERS (1) Opinion of 10 December 2014 (OJ C 230, 14.7.2015, p. 129). (2) Position of the European Parliament of 10 May 2016 (not yet published in the Official Journal) and decision of the Council of 30 May 2016. (3) Council Regulation (EC) No 597/2009 of 11 June 2009 on protection against subsidised imports from countries not members of the European Community (OJ L 188, 18.7.2009, p. 93). (4) See Annex V. (5) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (6) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (7) Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (see page 21 of this Official Journal). (8) Council Regulation (EC) No 1667/2006 of 7 November 2006 on glucose and lactose (OJ L 312, 11.11.2006, p. 1). (9) Council Regulation (EC) No 614/2009 of 7 July 2009 on the common system of trade for ovalbumin and lactalbumin (OJ L 181, 14.7.2009, p. 8). (10) Council Regulation (EC) No 1216/2009 of 30 November 2009 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products (OJ L 328, 15.12.2009, p. 10). ANNEX I ILLUSTRATIVE LIST OF EXPORT SUBSIDIES (a) The provision by governments of direct subsidies to a firm or an industry contingent upon export performance. (b) Currency retention schemes or any similar practices which involve a bonus on exports. (c) Internal transport and freight charges on export shipments, provided or mandated by governments, on terms more favourable than for domestic shipments. (d) The provision by governments or their agencies either directly or indirectly through government-mandated schemes, of imported or domestic products or services for use in the production of exported goods, on terms or conditions more favourable than for provision of like or directly competitive products or services for use in the production of goods for domestic consumption, if (in the case of products) such terms or conditions are more favourable than those commercially available (1) on world markets to their exporters. (e) The full or partial exemption, remission, or deferral (2) specifically related to exports, of direct taxes (3) or social welfare charges paid or payable by industrial or commercial enterprises. (f) The allowance of special deductions directly related to exports or export performance, over and above those granted in respect of production for domestic consumption, in the calculation of the base on which direct taxes are charged. (g) The exemption or remission, in respect of the production and distribution of exported products, of indirect taxes (4) in excess of those levied in respect of the production and distribution of like products when sold for domestic consumption. (h) The exemption, remission or deferral of prior-stage cumulative indirect taxes (4) on goods or services used in the production of exported products in excess of the exemption, remission or deferral of like prior-stage cumulative indirect taxes on goods or services used in the production of like products when sold for domestic consumption; provided, however, that prior-stage cumulative indirect taxes may be exempted, remitted or deferred on exported products even when not exempted, remitted or deferred on like products when sold for domestic consumption, if the prior-stage cumulative indirect taxes are levied on inputs that are consumed in the production of the exported product (making normal allowance for waste) (5). This item shall be interpreted in accordance with the guidelines on consumption of inputs in the production process contained in Annex II. (i) The remission or drawback of import charges (4) in excess of those levied on imported inputs that are consumed in the production of the exported product (making normal allowance for waste); provided, however, that in particular cases a firm may use a quantity of home market inputs equal to, and having the same quality and characteristics as, the imported inputs as a substitute for them in order to benefit from this provision if the import and the corresponding export operations both occur within a reasonable time period, not to exceed two years. This item shall be interpreted in accordance with the guidelines on consumption of inputs in the production process contained in Annex II and the guidelines in the determination of substitution drawback systems as export subsidies contained in Annex III. (j) The provision by governments (or special institutions controlled by governments) of export credit guarantee or insurance programmes, of insurance or guarantee programmes against increases in the cost of exported products or of exchange risk programmes, at premium rates which are inadequate to cover the long-term operating costs and losses of the programmes. (k) The grant by governments (or special institutions controlled by and/or acting under the authority of governments) of export credits at rates below those which they actually have to pay for the funds so employed (or would have to pay if they borrowed on international capital markets in order to obtain funds of the same maturity and other credit terms and denominated in the same currency as the export credit), or the payment by them of all or part of the costs incurred by exporters or financial institutions in obtaining credits, in so far as they are used to secure a material advantage in the field of export credit terms. Provided, however, that if a Member of the WTO is a party to an international undertaking on official export credits to which at least 12 original such Members are parties as of 1 January 1979 (or a successor undertaking which has been adopted by those original Members), or if in practice a Member of the WTO applies the interest rates provisions of the relevant undertaking, an export credit practice which is in conformity with those provisions shall not be considered an export subsidy. (l) Any other charge on the public account constituting an export subsidy in the sense of Article XVI of the GATT 1994. (1) \u2018Commercially available\u2019 means that the choice between domestic and imported products is unrestricted and depends only on commercial considerations. (2) Deferral may not amount to an export subsidy where, for example, appropriate interest charges are collected. (3) For the purposes of this Regulation: \u2014 \u2018direct taxes\u2019 means taxes on wages, profits, interests, rents, royalties, and all other forms of income, and taxes on the ownership of real property, \u2014 \u2018import charges\u2019 means tariffs, duties, and other fiscal charges not elsewhere enumerated in this footnote that are levied on imports, \u2014 \u2018indirect taxes\u2019 means sales, excise, turnover, value added, franchise, stamp, transfer, inventory and equipment taxes, border taxes and all taxes other than direct taxes and import charges, \u2014 \u2018prior-stage\u2019 indirect taxes are those levied on goods or services used directly or indirectly in making the product, \u2014 \u2018cumulative\u2019 indirect taxes are multi-staged taxes levied where there is no mechanism for subsequent crediting of the tax if the goods or services subject to tax at one stage of production are used in a succeeding state of production, \u2014 \u2018remission\u2019 of taxes includes the refund or rebate of taxes, \u2014 \u2018remission or drawback\u2019 includes the full or partial exemption or deferral of import charges. (4) See footnote 2 to point (e). (5) Point (h) does not apply to value added tax systems and border-tax adjustment in lieu thereof; the problem of the excessive remission of value added taxes is exclusively covered by point (g). ANNEX II GUIDELINES ON CONSUMPTION OF INPUTS IN THE PRODUCTION PROCESS (1) 1. Indirect tax rebate schemes can allow for exemption, remission or deferral of prior-stage cumulative indirect taxes levied on inputs that are consumed in the production of the exported product (making normal allowance for waste). Similarly, drawback schemes can allow for the remission or drawback of import charges levied on inputs that are consumed in the production of the exported product (making normal allowance for waste). 2. The illustrative list of export subsidies in Annex I makes reference to the term \u2018inputs that are consumed in the production of the exported product\u2019 in points (h) and (i). Pursuant to point (h), indirect tax rebate schemes can constitute an export subsidy to the extent that they result in exemption, remission or deferral of prior-stage cumulative indirect taxes in excess of the amount of such taxes actually levied on inputs that are consumed in the production of the exported product. Pursuant to point (i), drawback schemes can constitute an export subsidy to the extent that they result in a remission or drawback of import charges in excess of those actually levied on inputs that are consumed in the production of the exported product. Both points stipulate that normal allowance for waste must be made in findings regarding consumption of inputs in the production of the exported product. Point (i) also provides for substitution, where appropriate. 3. In examining whether inputs are consumed in the production of the exported product, as part of a countervailing duty investigation pursuant to this Regulation, the Commission must normally proceed on the following basis. 4. Where it is alleged that an indirect tax rebate scheme, or a drawback scheme, conveys a subsidy by reason of over-rebate or excess drawback of indirect taxes or import charges on inputs consumed in the production of the exported product, the Commission must normally first determine whether the government of the exporting country has in place and applies a system or procedure to confirm which inputs are consumed in the production of the exported product and in what amounts. Where such a system or procedure is determined to be applied, the Commission must normally then examine the system or procedure to see whether it is reasonable, effective for the purpose intended, and based on generally accepted commercial practices in the country of export. The Commission may deem it necessary to carry out, in accordance with Article 26(2), certain practical tests in order to verify information or to satisfy itself that the system or procedure is being effectively applied. 5. Where there is no such system or procedure, where it is not reasonable, or where it is instituted and considered reasonable but is found not to be applied or not to be applied effectively, a further examination by the exporting country based on the actual inputs involved will normally need to be carried out in the context of determining whether an excess payment occurred. If the Commission deems it necessary, a further examination may be carried out in accordance with point 4. 6. The Commission must normally treat inputs as physically incorporated if such inputs are used in the production process and are physically present in the product exported. An input need not be present in the final product in the same form in which it entered the production process. 7. In determining the amount of a particular input that is consumed in the production of the exported product, a \u2018normal allowance for waste\u2019 must normally be taken into account, and such waste must normally be treated as consumed in the production of the exported product. The term \u2018waste\u2019 refers to that portion of a given input which does not serve an independent function in the production process, is not consumed in the production of the exported product (for reasons such as inefficiencies) and is not recovered, used or sold by the same manufacturer. 8. The Commission's determination of whether the claimed allowance for waste is \u2018normal\u2019 must normally take into account the production process, the average experience of the industry in the country of export, and other technical factors, as appropriate. The Commission must bear in mind that an important question is whether the authorities in the exporting country have reasonably calculated the amount of waste, when such an amount is intended to be included in the tax or duty rebate or remission. (1) Inputs consumed in the production process are inputs physically incorporated, energy, fuels and oil used in the production process and catalysts which are consumed in the course of their use to obtain the exported product. ANNEX III GUIDELINES IN THE DETERMINATION OF SUBSTITUTION DRAWBACK SYSTEMS AS EXPORT SUBSIDIES I Drawback systems can allow for the refund or drawback of import charges on inputs which are consumed in the production process of another product and where the export of this latter product contains domestic inputs having the same quality and characteristics as those submitted for the imported inputs. Pursuant to point (i) of Annex I, substitution drawback systems can constitute an export subsidy to the extent that they result in an excess drawback of the import charges levied initially on the imported inputs for which drawback is being claimed. II In examining any substitution drawback system as part of a countervailing duty investigation pursuant to this Regulation, the Commission must normally proceed on the following basis: 1. point (i) of Annex I stipulates that home market inputs may be substituted for imported inputs in the production of a product for export provided such inputs are equal in quantity to, and have the same quality and characteristics as, the imported inputs being substituted. The existence of a verification system or procedure is important because it enables the government of the exporting country to ensure and demonstrate that the quantity of inputs for which drawback is claimed does not exceed the quantity of similar products exported, in whatever form, and that there is no drawback of import charges in excess of those originally levied on the imported inputs in question; 2. where it is alleged that a substitution drawback system conveys a subsidy, the Commission must normally first proceed to determine whether the government of the exporting country has in place and applies a verification system or procedure. Where such a system or procedure is determined to be applied, the Commission shall normally then examine the verification procedures to see whether they are reasonable, effective for the purpose intended, and based on generally accepted commercial practices in the country of export. To the extent that the procedures are determined to meet this test and are effectively applied, no subsidy will be presumed to exist. It may be deemed necessary by the Commission to carry out, in accordance with Article 26(2), certain practical tests in order to verify information or to satisfy itself that the verification procedures are being effectively applied; 3. where there are no verification procedures, where they are not reasonable, or where such procedures are instituted and considered reasonable but are found not to be actually applied or not to be applied effectively, there may be a subsidy. In such cases, further examination by the exporting country based on the actual transactions involved would need to be carried out to determine whether an excess payment occurred. If the Commission deems it necessary, a further examination may be carried out in accordance with point 2; 4. the existence of a substitution drawback provision under which exporters are allowed to select particular import shipments on which drawback is claimed should not of itself be considered to convey a subsidy; 5. an excess drawback of import charges within the meaning of point (i) of Annex I would be deemed to exist where governments paid interest on any monies refunded under their drawback schemes, to the extent of the interest actually paid or payable. ANNEX IV (This Annex reproduces Annex 2 to the Agreement on Agriculture. Any terms or expressions which are not explained herein or which are not self-explanatory are to be interpreted in the context of that Agreement.) DOMESTIC SUPPORT: THE BASIS OF EXEMPTION FROM THE REDUCTION COMMITMENTS 1. Domestic support measures for which exemption from the reduction commitments is claimed shall meet the fundamental requirement that they have no, or at most minimal, trade-distorting effects or effects on production. Accordingly, all measures for which exemption is claimed shall conform to the following basic criteria: (a) the support in question shall be provided through a publicly-funded government programme (including government revenue foregone) not involving transfers from consumers; and (b) the support in question shall not have the effect of providing price support to producers; plus policy-specific criteria and conditions as set out below. Government service programmes 2. General services Policies in this category involve expenditures (or revenue foregone) in relation to programmes which provide services or benefits to agriculture or the rural community. They shall not involve direct payments to producers or processors. Such programmes, which include but are not restricted to the following list, shall meet the general criteria in point 1 and policy-specific conditions where set out below: (a) research, including general research, research in connection with environmental programmes, and research programmes relating to particular products; (b) pest and disease control, including general and product-specific pest and disease control measures, such as early-warning systems, quarantine and eradication; (c) training services, including both general and specific training facilities; (d) extension and advisory services, including the provision of means to facilitate the transfer of information and the results of research to producers and consumers; (e) inspection services, including general inspection services and the inspection of particular products for health, safety, grading or standardisation purposes; (f) marketing and promotion services, including market information, advice and promotion relating to particular products but excluding expenditure for unspecified purposes that could be used by sellers to reduce their selling price or confer a direct economic benefit to purchasers; and (g) infrastructural services, including: electricity reticulation, roads and other means of transport, market and port facilities, water supply facilities, dams and drainage schemes, and infrastructural works associated with environmental programmes. In all cases the expenditure shall be directed to the provision or construction of capital works only, and shall exclude the subsidised provision of on-farm facilities other than for the reticulation of generally available public utilities. It shall not include subsidies to inputs or operating costs, or preferential user charges. 3. Public stockholding for food security purposes (1) Expenditures (or revenue foregone) in relation to the accumulation and holding of stocks of products which form an integral part of a food security programme identified in national legislation. This may include government aid to private storage of products as part of such a programme. The volume and accumulation of such stocks shall correspond to predetermined targets related solely to food security. The process of stock accumulation and disposal shall be financially transparent. Food purchases by the government shall be made at current market prices and sales from food security stocks shall be made at no less than the current domestic market price for the product and quality in question. 4. Domestic food aid (2) Expenditure (or revenue foregone) in relation to the provision of domestic food aid to sections of the population in need. Eligibility to receive the food aid shall be subject to clearly-defined criteria related to nutritional objectives. Such aid shall be in the form of direct provision of food to those concerned or the provision of means to allow eligible recipients to buy food either at market or at subsidised prices. Food purchases by the government shall be made at current market prices and the financing and administration of the aid shall be transparent. 5. Direct payments to producers Support provided through direct payments (or revenue foregone, including payments in kind) to producers for which exemption from reduction commitments as claimed shall meet the basic criteria set out in point 1, plus specific criteria applying to individual types of direct payment as set out in points 6 to 13. Where exemption from reduction is claimed for any existing or new type of direct payment other than those specified in points 6 to 13, it shall conform to criteria set out in points 6(b) to (e), in addition to the general criteria set out in point 1. 6. Decoupled income support (a) Eligibility for such payments shall be determined by clearly-defined criteria such as income, status as a producer or landowner, factor use or production level in a defined and fixed base period. (b) The amount of such payments in any given year shall not be related to, or based on, the type or volume of production (including livestock units) undertaken by the producer in any year after the base period. (c) The amount of such payments in any given year shall not be related to, or based on, the prices, domestic or international, applying to any production undertaken in any year after the base period. (d) The amount of such payments in any given year shall not be related to, or based on, the factors of production employed in any year after the base period. (e) No production shall be required in order to receive such payments. 7. Government financial participation in income insurance and income safety-net programmes (a) Eligibility for such payments shall be determined by an income loss, taking into account only income derived from agriculture, which exceeds 30 % of average gross income or the equivalent in net income terms (excluding any payments from the same or similar schemes) in the preceding three-year period or a three-year average based on the preceding five-year period, excluding the highest and the lowest entry. Any producer meeting this condition shall be eligible to receive the payments. (b) The amount of such payments shall compensate for less than 70 % of the producer's income loss in the year the producer becomes eligible to receive this assistance. (c) The amount of any such payments shall relate solely to income; it shall not relate to the type or volume of production (including livestock units) undertaken by the producer; or to the prices, domestic or international, applying to such production; or to the factors of production employed. (d) Where a producer receives in the same year payments pursuant to this point and pursuant to point 8 (relief from natural disasters), the total of such payments shall be less than 100 % of the producer's total loss. 8. Payments (made either directly or by way of a government financial participation in crop insurance schemes) for relief from natural disasters (a) Eligibility for such payments shall arise only following a formal recognition by government authorities that a natural or like disaster (including disease outbreaks, pest infestations, nuclear accidents, and war on the territory of the Member concerned) has occurred or is occurring; and shall be determined by a production loss which exceeds 30 % of the average of production in the preceding three-year period or a three-year average based on the preceding five-year period, excluding the highest and the lowest entry. (b) Payments made following a disaster shall be applied only in respect of losses of income, livestock (including payments in connection with the veterinary treatment of animals), land or other production factors due to the natural disaster in question. (c) Payments shall compensate for not more than the total cost of replacing such losses and shall not require or specify the type or quantity of future production. (d) Payments made during a disaster shall not exceed the level required to prevent or alleviate further loss as defined in criterion set out in point (b). (e) Where a producer receives in the same year payments pursuant to this point and pursuant to point 7 (income insurance and income safety-net programmes), the total of such payments shall be less than 100 % of the producer's total loss. 9. Structural adjustment assistance provided through producer retirement programmes (a) Eligibility for such payments shall be determined by reference to clearly defined criteria in programmes designed to facilitate the retirement of persons engaged in marketable agricultural production, or their movement to non-agricultural activities. (b) Payments shall be conditional upon the total and permanent retirement of the recipients from marketable agricultural production. 10. Structural adjustment assistance provided through resource retirement programmes (a) Eligibility for such payments shall be determined by reference to clearly defined criteria in programmes designed to remove land or other resources, including livestock, from marketable agricultural production. (b) Payments shall be conditional upon the retirement of land from marketable agricultural production for a minimum of three years, and in the case of livestock on its slaughter or definitive permanent disposal. (c) Payments shall not require or specify any alternative use for such land or other resources which involves the production of marketable agricultural products. (d) Payments shall not be related to either type or quantity of production or to the prices, domestic or international, applying to production undertaken using the land or other resources remaining in production. 11. Structural adjustment assistance provided through investment aids (a) Eligibility for such payments shall be determined by reference to clearly-defined criteria in government programmes designed to assist the financial or physical restructuring of a producer's operations in response to objectively demonstrated structural disadvantages. Eligibility for such programmes may also be based on a clearly defined government programme for the reprivatisation of agricultural land. (b) The amount of such payments in any given year shall not be related to, or based on, the type or volume of production (including livestock units) undertaken by the producer in any year after the base period other than as provided for under criterion (e). (c) The amount of such payments in any given year shall not be related to, or based on, the prices, domestic or international, applying to any production undertaken in any year after the base period. (d) The payments shall be given only for the period of time necessary for the realisation of the investment in respect of which they are provided. (e) The payments shall not mandate or in any way designate the agricultural products to be produced by the recipients except to require them not to produce a particular product. (f) The payments shall be limited to the amount required to compensate for the structural disadvantage. 12. Payments under environmental programmes (a) Eligibility for such payments shall be determined as part of a clearly-defined government environmental or conservation programme and be dependent on the fulfilment of specific conditions under the government programme, including conditions related to production methods or inputs. (b) The amount of payment shall be limited to the extra costs or loss of income involved in complying with the government programme. 13. Payments under regional assistance programmes (a) Eligibility for such payments shall be limited to producers in disadvantaged regions. Each such region must be a clearly designated contiguous geographical area with a definable economic and administrative identity, considered as disadvantaged on the basis of neutral and objective criteria clearly spelt out in a law or regulation and indicating that the region's difficulties arise out of more than temporary circumstances. (b) The amount of such payments in any given year shall not be related to, or based on, the type or volume of production (including livestock units) undertaken by the producer in any year after the base period other than to reduce that production. (c) The amount of such payments in any given year shall not be related to, or based on, the prices, domestic or international, applying to any production undertaken in any year after the base period. (d) Payments shall be available only to producers in eligible regions, but generally available to all producers within such regions. (e) Where related to production factors, payments shall be made at a degressive rate above a threshold level of the factor concerned. (f) The payments shall be limited to the extra costs or loss of income involved in undertaking agricultural production in the prescribed area. (1) For the purpose of point 3 of this Annex, governmental stockholding programmes for food security purposes in developing countries whose operation is transparent and conducted in accordance with officially published objective criteria or guidelines shall be considered to be in conformity with the provisions of this point, including programmes under which stocks of foodstuffs for food security purposes are acquired and released at administered prices, provided that the difference between the acquisition price and the external reference price is accounted for in the AMS. (2) For the purposes of points 3 and 4 of this Annex, the provision of foodstuffs at subsidised prices with the objective of meeting food requirements of urban and rural poor in developing countries on a regular basis at reasonable prices shall be considered to be in conformity with the provisions of this point. ANNEX V REPEALED REGULATION WITH THE AMENDMENT THERETO Council Regulation (EC) No 597/2009 (OJ L 188, 18.7.2009, p. 93) Regulation (EU) No 37/2014 of the European Parliament and of the Council (OJ L 18, 21.1.2014, p. 1) Only point 18 of the Annex ANNEX VI CORRELATION TABLE Regulation (EC) No 597/2009 This Regulation Articles 1 to 11 Articles 1 to 11 Article 12(1) to (4) Article 12(1) to (4) Article 12(6) Article 12(5) Articles 13 and 14 Articles 13 and 14 Article 15(1) Article 15(1) Article 15(2), first sentence Article 15(2), first subparagraph Article 15(2), second sentence Article 15(2), second subparagraph Article 15(3) Article 15(3) Articles 16 to 27 Articles 16 to 27 Article 28(1) to (4) Article 28(1) to (4) Article 28(5), first sentence Article 28(5), first subparagraph Article 28(5), second sentence Article 28(5), second subparagraph Article 28(6) Article 28(6) Articles 29 to 33 Articles 29 to 33 Article 33a Article 34 Article 34 Article 35 Article 35 Article 36 Annexes I to IV Annexes I to IV Annex V \u2014 Annex VI \u2014 \u2014 Annex V \u2014 Annex VI", "summary": "Anti-subsidy measures Anti-subsidy measures SUMMARY OF: Regulation (EU) 2016/1037 on protection against subsidised imports from non-EU countries WHAT IS THE AIM OF THE REGULATION? Regulation (EU) 2016/1037 sets out EU rules on the protection against subsidised imports from non-EU countries and the conditions for the application of countervailing measures. It has been amended three times: by Regulation (EU) 2017/2321, by Regulation (EU) 2018/825 and by Delegated Regulation (EU) 2020/1173. KEY POINTS Regulation (EU) 2016/1037 A countervailing duty is applied to counteract the injurious effects of the subsidised imports of a product on the EU producers of the same product market and to restore fair competition. The duty is paid by the importer and collected by the customs authorities of the EU country concerned. Four conditions must be met before anti-subsidy measures can be imposed on imports of a product: the imports benefit from a specific subsidy; there must be material injury* to the EU industry producing the like product*; there must be a causal link between the subsidised imports and the material injury; and the anti-subsidy measure must not be against EU interest \u2014 the measures should not cause more harm to its overall economy than the relief brought to the industry suffering from the imports. Initiating a complaint An anti-subsidy complaint is filed with the European Commission by or on behalf of the EU producers of the product concerned either directly or via the authorities of an EU country. Other parties, such as trade unions, may also submit complaints jointly with the EU industry and become interested parties in the proceedings. In special circumstances, the Commission may also open an investigation into subsidies on its own initiative. Any complaint must include evidence of subsidy, injury and a causal link between the allegedly subsidised imports and the alleged injury. To protect confidential business data, two versions of a complaint need to be lodged: a confidential version and a non-confidential version. The first will be available only to Commission staff directly working on the case. The non-confidential version will be accessible by all interested parties once the investigation is opened, upon request. The Commission must examine the accuracy and adequacy of the evidence provided in the complaint to determine whether there is a sufficient basis to justify initiating an investigation. This must be done within 45 days of the complaint being lodged. Prior to initiating an anti-subsidy investigation, the Commission is required to offer consultations to the government of the exporting country. Anti-subsidy investigation Once the Commission decides to launch an investigation, it must publish a notice in the Official Journal of the European Union. It contacts all known manufacturers and all other interested parties requesting them to complete questionnaires by a strict deadline. Where there are many potentially interested parties, the Commission may decide to carry out its investigation on the basis of a sample of operators (exporting producers, EU manufacturers, importers, users). Where, based on its investigation, the Commission considers that subsidisation causing injury has occurred, anti-subsidy measures may be imposed on imports into the EU of the product concerned. These measures generally take the form of: an ad valorem duty \u2014 a percentage of the import value of the product concerned;specific duties \u2014 a fixed value for a certain amount of goods, e.g. \u20ac100 per tonne of a product; ora price undertaking \u2014 a commitment by an exporter to respect minimum import prices. The authorities of the exporting country can also undertake to eliminate the subsidy or take measures concerning the effects of the subsidy. Provisional measures, if any, must be imposed no later than 9 months after the investigation has begun and must remain in place for a maximum of 4 months. This may be followed by the imposition of definitive measures, which remain in force for 5 years. Duties are paid by the importer in the EU and are collected by the national customs authorities of the EU countries concerned. Measures in force may be reviewed (interim review) under certain conditions. The scope of this review is usually limited to one or various elements of the initial measures, e.g. the level of subsidisation and/or injury, the product scope, or the form of the measures. After 5 years, the measures lapse unless an expiry review concludes that, if the measures were to expire, subsidisation and material injury would likely continue or recur. Importers may request a full or partial refund of duties paid if they can show that the subsidy margin, on the basis of which the duties were paid, has been eliminated or reduced. The EU\u2019s anti-subsidy rules are based on the global standards set by the World Trade Organization (WTO). Amending Regulation (EU) 2017/2321 As experience showed that some subsidies are only discovered during the relevant investigation, amending Regulation (EU) 2017/2321 added a subparagraph requiring the Commission, in those situations, to offer additional consultations regarding these subsidies to the country of origin and/or of export concerned with regard to such subsidies identified in the course of the investigation. Amending Regulation (EU) 2018/825 Among other things, the regulation does the following. It streamlines the investigation process and makes it easier for smaller businesses to participate in trade defence investigations (including the creation of a small and medium-sized enterprise (SME) trade defence helpdesk). It amends how the rule known as the \u2018lesser duty rule\u2019 is applied in anti-subsidy cases. The EU had previously imposed measures at a level lower than the full extent of the subsidisation, where a lower level (the \u2018injury margin\u2019) was sufficient to remove the injury suffered by the EU industry. Under the new rules, anti-subsidy measures can fully offset the subsidies that an exporter has received, provided this is in the interest of the EU as a whole to do so. It introduces new rules on calculating the \u2018non-injurious price\u2019 (the price that the industry is expected to have charged under normal circumstances). The calculation may now take into account the cost of necessary investments, for example in infrastructure or research and development, but also future expenses related to social and environmental standards, for example under the EU\u2019s emission trading system. The non-injurious price now assumes a minimum profit of 6% that will be included in the calculation, with a higher profit margin possible on a case-by-case basis. It introduced a pre-disclosure period, during which interested parties received information on the imposition, or not, of provisional measures 3 weeks in advance. In the review carried out in line with amending Regulation (EU) 2018/825, the Commission concluded that, overall, no additional injury to the EU industry had been caused by the imports during the pre-disclosure period. It therefore adopted a delegated act amending the duration of the period of pre-disclosure to 4 weeks (Delegated Regulation (EU) 2020/1173). FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) 2016/1037 has applied since 20 July 2016. It codified and replaced Regulation (EC) No 597/2009 and its subsequent amendments. Amending Regulation (EU) 2017/2321 has applied since 20 December 2017. Amending Regulation (EU) 2018/825 has applied since 8 June 2018. Delegated Regulation (EU) 2020/1173 has applied since 11 August 2020. BACKGROUND A subsidy is a financial contribution, such as a grant or a loan, usually paid by the government of a non-EU country. It confers benefit to a business or industry exporting its products into the EU, thus distorting competition in the EU market. To counteract this distortion and restore fair competition, the EU may impose countervailing duties on such imports. The EU\u2019s anti-subsidy rules are based on the global standards set by the WTO. For more information, see: Anti-subsidy (European Commission)Notice: On the consequences of the COVID-19 outbreak on anti-dumping and anti-subsidy investigations. KEY TERMS Material injury: substantial injury to EU industry, e.g. loss of market share, reduced price levels and/or reduced profitability. Like product: a product which is identical to or closely resembles the imported product under consideration. MAIN DOCUMENT Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (codification) (OJ L 176, 30.6.2016, pp. 55-91) Successive amendments to Regulation (EU) 2016/1037 have been incorporated into the original text. This consolidated version is of documentary value only. last update 16.10.2020"}
{"article": "26.3.2021 EN Official Journal of the European Union L 107/30 REGULATION (EU) 2021/523 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 173 and the third paragraph of Article 175 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The COVID-19 pandemic is a major shock to the global and Union economy and is having a major social and economic impact across Member States and regions. Due to the necessary containment measures, economic activity in the Union dropped significantly. The contraction in Union GDP in 2020 is expected to be around 7,4 %, far deeper than during the financial crisis in 2009. Investment activity has dropped significantly. Vulnerabilities such as the over-reliance on non-diversified external supply sources and a lack of critical infrastructure need to be addressed, in particular for small and medium-sized enterprises (SMEs), including micro-enterprises, for instance by diversifying and strengthening strategic value chains, to improve the Union\u2019s emergency response as well as the resilience of the entire economy, while maintaining its openness to competition and trade in line with its rules. Even before the pandemic, while a recovery in investment-to-GDP ratios in the Union could be observed, it remained below what might be expected in a strong recovery and was insufficient to compensate for years of underinvestment following the 2009 crisis. More importantly, the current investment levels and forecasts do not cover the Union\u2019s needs for structural investment to restart and sustain long-term growth in the face of technological change and global competitiveness, including for innovation, skills, infrastructure, SMEs and the need to address key societal challenges such as sustainability and population ageing. Consequently, in order to achieve the Union\u2019s policy objectives and to support a swift, sustainable, inclusive, lasting and healthy economic recovery, support is necessary to address market failures and suboptimal investment situations and to reduce the investment gap in targeted sectors. (2) Evaluations have underlined that the variety of financial instruments delivered under the 2014-2020 Multiannual Financial Framework period has led to some overlaps in their scope. That variety has also produced complexity for intermediaries and final recipients who were confronted with different eligibility and reporting rules. The absence of compatible rules also hampered the combination of several Union funds, although such combinations would have been beneficial in order to support projects in need of different types of funding. Therefore, a single fund, the InvestEU Fund, which builds on the experience of the European Fund for Strategic Investments (EFSI) set up under the Investment Plan for Europe, should be set up in order to provide more efficiently functioning support to final recipients by integrating and simplifying the financing offered under a single budgetary guarantee scheme, thereby improving the impact of Union support while reducing the cost to the Union payable from the budget. (3) In recent years, the Union has adopted ambitious strategies to complete the internal market and to stimulate sustainable and inclusive growth and jobs. Such strategies include \u2018Europe 2020 \u2013 A strategy for smart, sustainable and inclusive growth\u2019 of 3 March 2010, \u2018Action Plan on Building a Capital Markets Union\u2019 of 30 September 2015, \u2018Closing the loop \u2013 An EU action plan for the Circular Economy\u2019 of 2 December 2015, \u2018A European Strategy for Low-Emission Mobility\u2019 of 20 July 2016, \u2018Space Strategy for Europe\u2019 of 26 October 2016, \u2018Clean Energy for all Europeans\u2019 of 30 November 2016, \u2018European Defence Action Plan\u2019 of 30 November 2016, \u2018Launching the European Defence Fund\u2019 of 7 June 2017, the Interinstitutional Proclamation on the European Pillar of Social Rights of 13 December 2017, \u2018A new European Agenda for Culture\u2019 of 22 May 2018, the \u2018European Green Deal\u2019 of 11 December 2019, the \u2018European Green Deal Investment Plan\u2019 of 14 January 2020, the \u2018Strong Social Europe for Just Transitions\u2019 of 14 January 2020, the strategy for \u2018Shaping Europe\u2019s digital future\u2019, \u2018A European Strategy for Data\u2019 and the White Paper \u2018On Artificial Intelligence - A European approach to excellence and trust\u2019 of 19 February 2020, \u2018A New Industrial Strategy for Europe\u2019 of 10 March 2020 and \u2018SME Strategy for a sustainable and digital Europe\u2019 of 10 March 2020. The InvestEU Fund should exploit and reinforce synergies between those mutually reinforcing strategies by providing support for investment and access to financing. In addition, the Union has adopted Regulation (EU) 2020/852 of the European Parliament and of the Council (3). (4) At Union level, the European Semester of economic policy coordination is the framework for identifying national reform priorities and monitoring their implementation. Member States, where appropriate in cooperation with local and regional authorities, develop their own national multiannual investment strategies in support of those reform priorities. Those strategies should be presented alongside the yearly national reform programmes as a way of outlining and coordinating priority investment projects that are to be supported by national funding, Union funding, or both. Those strategies should also use Union funding in a coherent manner and maximise the added value of the financial support to be received in particular from the European structural and investment funds, the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (4) and the InvestEU Programme. (5) The InvestEU Fund should contribute to improving the competitiveness and socio-economic convergence and cohesion of the Union, including in the fields of innovation and digitisation, to the efficient use of resources in accordance with the circular economy, to the sustainability and inclusiveness of the Union\u2019s economic growth and to the social resilience and integration of Union capital markets, including through solutions that address the fragmentation of Union capital markets and that diversify sources of financing for Union enterprises. To that end, the InvestEU Fund should support projects that are technically and economically viable by providing a framework for the use of debt, risk sharing and equity and quasi-equity instruments backed up by a guarantee from the Union budget and by financial contributions from implementing partners as relevant. The InvestEU Fund should be demand-driven, while at the same time focused on providing strategic, long-term benefits in relation to key areas of Union policy which would otherwise not be funded or would be insufficiently funded, thereby contributing to meeting the Union\u2019s policy objectives. Support from the InvestEU Fund should cover a wide range of sectors and regions, but should avoid excessive sectoral or geographical concentration and should facilitate access to financing of projects composed of partner entities in multiple regions across the Union, including projects that foster the development of networks, clusters and digital innovation hubs. (6) The cultural and creative sectors are key as well as fast growing sectors in the Union that can play an important part in ensuring a sustainable recovery, generating both economic and cultural value from intellectual property and individual creativity. However, restrictions on social contacts put in place during the COVID-19 crisis have had a significant negative economic impact on those sectors. Moreover, the intangible nature of assets in those sectors limits the access of SMEs and organisations from those sectors to private financing which is essential to be able to invest, scale up and compete at an international level. The InvestEU Programme should continue to facilitate access to finance for SMEs and organisations from those sectors. The cultural and creative, audiovisual and media sectors are essential for freedom of speech and cultural diversity and for building democratic and cohesive societies in the digital age, and are an intrinsic part of our sovereignty and autonomy. Investment in those sectors would determine their competitiveness and their long-term capacity to produce and distribute high-quality content to wide audiences across national borders. (7) With a view to fostering sustainable and inclusive growth, investment and employment, and thereby contributing to improved well-being, to fairer income distribution and to greater economic, social and territorial cohesion in the Union, the InvestEU Fund should support investments in tangible and intangible assets, including in cultural heritage. Projects funded by the InvestEU Fund should meet Union environmental and social standards, including standards on labour rights. Interventions through the InvestEU Fund should complement Union support delivered through grants. (8) The Union endorsed the objectives set out in the United Nations 2030 Agenda for Sustainable Development (the \u20182030 Agenda\u2019), its Sustainable Development Goals (SDGs) and the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (5) (Paris Agreement) as well as the Sendai Framework for Disaster Risk Reduction 2015-2030. To achieve those objectives, as well as the objectives set out in the environmental policies of the Union, action pursuing sustainable development needs to be significantly stepped up. Therefore, the principles of sustainable development should feature prominently in the design of the InvestEU Fund. (9) The InvestEU Programme should contribute to building a sustainable finance system in the Union which supports the reorientation of private capital towards sustainable investments in accordance with the objectives set out in the communication of the Commission of 8 March 2018 entitled \u2018Action Plan: Financing Sustainable Growth\u2019 and the communication of the Commission of 14 January 2020 on the European Green Deal Investment Plan. (10) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement, and the commitment to the United Nations Sustainable Development Goals, as well as the objective of EU climate neutrality by 2050 and the Union\u2019s new 2030 climate targets, actions under this Regulation should contribute to the achievement of a target of 30 % of all MFF expenditure being spent on mainstreaming climate objectives and the ambition of 7,5 % of the budget reflecting biodiversity expenditures in 2024 and 10 % in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. Actions under the InvestEU Programme are expected to contribute at least 30 % of the overall financial envelope of the InvestEU Programme to climate objectives. (11) The contribution of the InvestEU Fund to the achievement of the climate target will be tracked through a Union climate tracking system to be developed by the Commission in cooperation with potential implementing partners, appropriately using the criteria established by Regulation (EU) 2020/852 for determining whether an economic activity is environmentally sustainable. The InvestEU Programme should also contribute to the implementation of other dimensions of the SDGs. (12) According to the 2018 Global Risks Report issued by the World Economic Forum, five of the ten most critical risks threatening the global economy relate to the environment. Such risks include the pollution of air, soil, inland waters and oceans, extreme weather events, biodiversity losses and failures of climate-change mitigation and adaptation. Environmental principles are strongly embedded in the Treaties and many of the Union\u2019s policies. Therefore, the mainstreaming of environmental objectives should be promoted in operations related to the InvestEU Fund. Environmental protection and the prevention and management of related risks should be integrated in the preparation and implementation of investments. The Union should also track its biodiversity-related and air pollution control-related expenditures in order to fulfil the reporting obligations under the Convention on Biological Diversity (6) and under Directive (EU) 2016/2284 of the European Parliament and of the Council (7). Investment allocated to environmental sustainability objectives should therefore be tracked using common methodologies that are consistent with methodologies developed under other Union programmes that apply to climate, biodiversity and air pollution management in order to allow the assessment of the individual and combined impact of investments on the principal components of natural capital, namely air, water, land and biodiversity. (13) Investment projects that receive substantial Union support, in particular in the area of infrastructure, should be screened by the implementing partner to determine whether they have an environmental, climate or social impact. Investment projects that have such an impact should be subject to sustainability proofing in accordance with guidance that should be developed by the Commission in close cooperation with potential implementing partners under the InvestEU Programme. This guidance should appropriately use the criteria established by Regulation (EU) 2020/852 for determining whether an economic activity is environmentally sustainable, including the principle of \u2018do no significant harm\u2019, and consistent with the guidance developed for other programmes of the Union. Consistent with the principle of proportionality, such guidance should include adequate provisions for avoiding undue administrative burdens, and projects below a certain size as to be defined in the guidance should be excluded from the sustainability proofing. Where an implementing partner concludes that no sustainability proofing is to be carried out, it should provide a justification to the investment committee established for the InvestEU Fund (the \u2018Investment Committee\u2019). Operations that are inconsistent with the achievement of the climate objectives should not be eligible for support under this Regulation. (14) Low infrastructure investment rates in the Union during the financial crisis and again during the COVID-19 crisis have undermined the Union\u2019s ability to boost sustainable growth, its efforts towards climate neutrality, its competitiveness and convergence and the creation of jobs. This also creates the risk of consolidating imbalances and divergences and inequalities within and between Member States, impacting on long-term development at Union, national or regional level. Sizeable investments in Union infrastructure, in particular with regard to interconnection and energy efficiency and to creating a Single European Transport Area, are essential to meeting the Union\u2019s sustainability targets, including the Union\u2019s commitments towards the SDGs, and the 2030 energy and climate targets. Accordingly, support from the InvestEU Fund should target investments in transport, energy, including energy efficiency and renewable energy sources and other safe and sustainable low-emission energy sources, environmental infrastructure, infrastructure related to climate action, maritime infrastructure and digital infrastructure, including fast and ultra-fast broadband connectivity throughout the Union, to accelerate the digital transformation of the Union economy. The InvestEU Programme should prioritise areas that are under-invested, and in which additional investment is required. To maximise the impact and added value of Union financing support, it is appropriate to promote a streamlined investment process that enables visibility of the project pipeline and maximises synergies across relevant Union programmes in areas such as transport, energy and digitisation. Bearing in mind threats to safety and security, investment projects receiving Union support should include measures for infrastructure resilience, including infrastructure maintenance and safety, and should take into account principles for the protection of citizens in public spaces. This should be complementary to the efforts made by other Union funds that provide support for security components of investments in public spaces, transport, energy and other critical infrastructure, such as the European Regional Development Fund. (15) Where appropriate, the InvestEU Programme should contribute to the objectives of Directive (EU) 2018/2001 of the European Parliament and of the Council (8) and Regulation (EU) 2018/1999 of the European Parliament and of the Council (9), as well as promote energy efficiency in investment decisions. (16) Genuine multimodality is an opportunity to create an efficient and environmentally friendly transport network that uses the maximum potential of all means of transport and generates synergy between them. The InvestEU Programme should support investments in multimodal transport hubs, which \u2013 in spite of their significant economic potential and business cases \u2013 carry a significant risk for private investors. The InvestEU Programme should also contribute to the development and deployment of Intelligent Transport Systems (ITS). The InvestEU Programme should help to boost efforts to design and apply technologies that help to improve the safety of vehicles and road infrastructure. (17) The InvestEU Programme should contribute to Union policies concerning seas and oceans through the development of projects and enterprises in the area of the blue economy, and the Sustainable Blue Economy Finance Principles. This may include interventions in the area of maritime entrepreneurship and industry, an innovative and competitive maritime industry, as well as renewable marine energy and circular economy. (18) Although the level of overall investment in the Union was increasing before the COVID-19 crisis, investment in higher-risk activities such as research and innovation was still inadequate and is now expected to have suffered a significant hit as a result of the crisis. Research and innovation have a crucial role to play in overcoming the crisis, consolidating the resilience of the Union to tackle future challenges and creating the necessary technologies to achieve Union policies and goals. The InvestEU Fund should contribute to reaching the overall target of investing at least 3 % of Union GDP in research and innovation. The achievement of that target would require Member States and the private sector to proceed with their own reinforced investment actions in research, development and innovation, to avoid underinvestment in research and innovation, which is damaging to the industrial and economic competitiveness of the Union and the quality of life of its citizens. The InvestEU Fund should provide appropriate financial products to cover different stages of the innovation cycle and a wide range of stakeholders, in particular to allow the upscaling of and deployment of solutions at a commercial scale in the Union in order to make such solutions competitive on world markets and to promote Union excellence in sustainable technologies at a global level, in synergy with Horizon Europe to be established by a Regulation of the European Parliament and of the Council establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (the \u2018Horizon Europe Regulation\u2019), including the European Innovation Council. In that regard, the experience gained from the financial instruments, such as InnovFin \u2013 EU Finance for Innovators, deployed under Horizon 2020 to facilitate and accelerate access to finance for innovative businesses should serve as a strong basis to deliver this targeted support. (19) Tourism, including the hospitality industry, is an area of great importance for the Union economy and is currently experiencing a particularly severe contraction as a result of the COVID-19 pandemic. That contraction is particularly damaging for SMEs and family businesses and has caused large-scale unemployment. The InvestEU Programme should contribute to strengthening the recovery, long-term competitiveness and sustainability of the sector, and its value chains, by supporting operations promoting sustainable, innovative and digital tourism including innovative measures to reduce the climate and environmental footprint of the sector. (20) A significant effort is urgently needed to invest in and boost the digital transformation and to distribute the benefits of it to all Union citizens and businesses. The strong policy framework of the Digital Single Market Strategy should now be matched by investment of a similar ambition, including in artificial intelligence in line with the Digital Europe Programme to be established by a Regulation of the European Parliament and of the Council establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240. (21) SMEs represent over 99 % of businesses in the Union and their economic value is significant and crucial. However, they face difficulties when accessing finance because of their perceived high risk and lack of sufficient collateral. Additional challenges arise from the need for SMEs and social economy enterprises to stay competitive by engaging in digitisation, internationalisation, transformation in a logic of circular economy, innovation activities and skilling up their workforce. SMEs have been particularly badly hit by the COVID-19 crisis. Moreover, SMEs and social economy enterprises have access to a more limited set of financing sources than larger enterprises, because they typically do not issue bonds, and have only limited access to stock exchanges and large institutional investors. Innovative solutions such as the acquisition of a business or ownership stake in a business by employees are also increasingly common for SMEs and social economy enterprises. The difficulty in accessing finance is even greater for those SMEs whose activities focus on intangible assets. SMEs in the Union rely heavily on banks and on debt financing in the form of bank overdrafts, bank loans or leasing. Supporting SMEs that face the above challenges by making it easier for them to gain access to finance and by providing more diversified sources of funding is necessary to increase the ability of SMEs to finance their creation, growth, innovation and sustainable development, ensure their competitiveness and withstand economic shocks to make the economy and the financial system more resilient during economic downturns and to maintain SMEs\u2019 ability to create jobs and social well-being. This Regulation is also complementary to the initiatives already undertaken in the context of the Capital Markets Union. The InvestEU Fund should therefore build on successful Union programmes, such as the Programme for the Competitiveness of Enterprises and SMEs (COSME); provide support to digital start-ups and innovative SMEs to enable them to better compete and scale up; provide working capital and investment throughout the life cycle of a company; provide financing for leasing transactions; and provide an opportunity to focus on specific, more targeted financial products. It should also maximise the firepower of public/private fund vehicles, such as the SME IPO (Initial Public Offering) Fund, seeking to support SMEs through channelling more private and public equity. (22) As set out in the Commission\u2019s Reflection paper on the social dimension of Europe of 26 April 2017, the Communication on European Pillar of Social Rights, the Union framework for the UN Convention on the Rights of Persons with Disabilities and the Communication on \u2018Strong Social Europe for Just Transitions\u2019 of 14 January 2020, building a more inclusive and fair Union is a key priority for the Union to tackle inequality and foster social inclusion policies in Europe. Inequality of opportunities affects in particular access to education, training, culture, employment, health and social services. Investment in the social, skills and human capital-related economy, as well as in the integration of vulnerable populations in the society, can enhance economic opportunities, especially if coordinated at Union level. The COVID-19 crisis has revealed a significant need for investment in social infrastructure. The InvestEU Fund should be used to support investment in education and training, including the re-skilling and upskilling of workers, inter alia in regions depending on a carbon intensive economy and affected by the structural transition to a low-carbon economy. It should be used to support projects that generate positive social impacts and enhance social inclusion by helping to increase employment across all regions, in particular among the unskilled and long-term unemployed, and to improve the situation with regard to gender equality, equal opportunities, non-discrimination, accessibility, intergenerational solidarity, the health and social services sector, social housing, homelessness, digital inclusiveness, community development, the role and place of young people in society as well as vulnerable people, including third country nationals. The InvestEU Programme should also support European culture and creativity that has a social goal. (23) The COVID-19 crisis has had a particularly serious impact on women, from both a social and an economic perspective. Bearing that in mind, the InvestEU Programme should contribute to the achievement of the Union\u2019s policies on equality between women and men, inter alia, by addressing the digital gap between them and by helping to encourage female creativity and entrepreneurial potential. (24) To counter the negative effects of profound transformations of societies in the Union and of the labour market in the coming decade, it is necessary to invest in human capital, social infrastructure, microfinance, ethical and social enterprise finance and new social economy business models, including social impact investment and social outcomes contracting. The InvestEU Programme should strengthen nascent social market ecosystem to increase the supply of and access to finance to micro- and social enterprises and social solidarity institutions, in order to meet the demand of those who need it the most. The report of the High-Level Task Force on Investing in Social Infrastructure in Europe of January 2018 entitled \u2018Boosting Investment in Social Infrastructure in Europe\u2019 has identified a total investment gap of at least EUR 1,5 trillion in social infrastructure and services for the period between 2018 and 2030, including education, training, health and housing. This calls for support, including at the Union level. Therefore, the collective power of public, commercial and philanthropic capital, as well as support from foundations and from alternative types of finance providers such as ethical, social and sustainable actors, should be harnessed to support the development of the social market value chain and a more resilient Union. (25) In the economic crisis caused by the COVID-19 pandemic, market allocation of resources is not fully efficient and perceived risk impairs private investment flow significantly. Under such circumstances, the key feature of the InvestEU Fund of de-risking economically viable projects to crowd in private finance is particularly valuable, inter alia in order to counteract the risk of an asymmetric recovery. The InvestEU Programme should be able to provide crucial support to companies in the recovery phase, including capital support for SMEs that were negatively affected by the COVID-19 crisis and were not already in difficulty in State aid terms at the end of 2019, and at the same time ensure a strong focus of investors on the Union\u2019s medium- and long-term policy priorities such as the European Green Deal, the European Green Deal Investment Plan, the Strategy on shaping Europe\u2019s digital future, the New Industrial Strategy for Europe, and the Strong Social Europe for Just Transitions, taking account of the principle of \u2018do no significant harm\u2019. It should significantly increase the risk-taking capacity of the European Investment Bank (EIB) Group and national promotional banks and institutions and other implementing partners in support of economic recovery. (26) The deep contraction in Union GDP resulting from the COVID-19 crisis renders adverse social effects inevitable. The COVID-19 pandemic has shown the need for strategic vulnerabilities to be urgently and efficiently addressed in order to improve the Union\u2019s emergency response as well as the resilience and sustainability of the entire economy. Only a resilient, sustainable, inclusive and integrated Union economy can preserve the integrity of the internal market and the level playing field also to the benefit of the hardest-hit Member States and regions. (27) The InvestEU Fund should operate through four policy windows that mirror the key Union policy priorities, namely, sustainable infrastructure; research, innovation and digitisation; SMEs; and social investment and skills. (28) Although the SME policy window should primarily focus on benefitting SMEs, small mid-cap companies should also be eligible under it. Mid-cap companies should be eligible for support under the other three policy windows. (29) As set out in the European Green Deal and the European Green Deal Investment Plan, a Just Transition Mechanism is to be established in order to address the social, economic and environmental consequences of reaching the Union\u2019s 2030 climate target and its target of achieving climate neutrality by 2050. That mechanism would be composed of three pillars, namely a Just Transition Fund to be established by a Regulation of the European Parliament and of the Council establishing the Just Transition Fund (the \u2018Just Transition Fund Regulation\u2019) (pillar 1), a dedicated just transition scheme under the InvestEU Programme (pillar 2) and a public sector loan facility to be established by a Regulation of the European Parliament and of the Council on the public sector loan facility under the Just Transition Mechanism (the \u2018Public Sector Loan Facility Regulation for 2021-2027\u2019) (pillar 3). That mechanism should focus on the regions that are most affected by the transition given their dependence on fossil fuels, including coal, peat and oil shale or greenhouse gas-intensive industrial processes, and that have less capacity to finance the necessary investments. The just transition scheme should also provide support for financing to generate investment to the benefit of just transition territories. The InvestEU Advisory Hub should provide for the possibility for the respective territories to benefit from technical assistance. (30) To implement pillar 2 under the Just Transition Mechanism, a dedicated just transition scheme under the InvestEU Programme should be established horizontally across all policy windows, supporting additional investment to benefit the territories identified in territorial just transition plans, established in accordance with the Just Transition Fund Regulation. That scheme should enable investments in a wide range of projects, in line with the eligibility criteria of the InvestEU Programme. Projects in territories identified in territorial just transition plans, or projects that benefit the transition of those territories, even if they are not located in the territories themselves, may benefit from the Scheme, but only when funding outside the just transition territories is key to the transition in those territories. (31) It should be possible to support strategic investments, including important projects of common European interest, under any policy window, particularly in view of the green and digital transitions and the need to enhance competitiveness and resilience, promote entrepreneurship and job creation and strengthen strategic value chains. (32) Each policy window should be composed of two compartments, that is to say an EU compartment and a Member State compartment. The EU compartment should address Union-wide or Member State specific market failures or suboptimal investment situations in a proportionate manner. Operations supported should have a clear Union added value. The Member State compartment should give Member States as well as regional authorities via their Member State the possibility of contributing a share of their resources from the funds under shared management to the provisioning for the EU guarantee and of using the EU guarantee for financing or investment operations in order to address specific market failures or suboptimal investment situations in their own territories, including in vulnerable and remote areas such as the outermost regions of the Union, as to be set out in the contribution agreement, in order to achieve objectives of the funds under shared management. The Member State compartment should also give Member States the possibility of contributing other additional amounts, including those made available pursuant to Regulation (EU) 2021/241, to the provisioning for the EU guarantee and of using the EU guarantee for financing or investment operations for the purposes laid down in the contribution agreement, which should include, where relevant, the purposes of measures under a recovery and resilience plan. This could, inter alia, allow for capital support for SMEs that were negatively affected by the COVID-19 crisis and were not already in difficulty in State aid terms at the end of 2019. Operations supported by the InvestEU Fund through either EU or Member State compartments should not duplicate or crowd out private financing or distort competition in the internal market. (33) The Member State compartment should be specifically designed to allow the use of funds under shared management or other additional amounts contributed by Member States, including those made available pursuant to Regulation (EU) 2021/241 to provision a guarantee issued by the Union. That possibility would increase the added value of the EU guarantee by providing support under it to a wider range of final recipients and projects and diversifying the means of achieving the objectives of the funds under shared management or recovery and resilience plans, while ensuring a consistent risk management of the contingent liabilities by implementing the EU guarantee under indirect management. The Union should guarantee the financing and investment operations provided for in the guarantee agreements concluded between the Commission and implementing partners under the Member State compartment. The funds under shared management or other additional amounts contributed by Member States, including those made available pursuant to Regulation (EU) 2021/241, should provide the provisioning for the guarantee, following a provisioning rate determined by the Commission and set out in the contribution agreement concluded with the Member State, based on the nature of the operations and the resulting expected losses. The Member State would assume losses above the expected losses by issuing a back-to-back guarantee in favour of the Union that should remain in place as long as any financing and investment operations under that Member State compartment are outstanding. Such arrangements should be concluded in a single contribution agreement with each Member State that voluntarily chooses such option. The contribution agreement should encompass the one or more specific guarantee agreements to be implemented within the Member State concerned on the basis of the rules of the InvestEU Fund, and any regional ring-fencing. The setting out of the provisioning rate on a case-by-case basis requires a derogation from Article 211(1) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (10) (the \u2018Financial Regulation\u2019). This set-up provides also a single set of rules for budgetary guarantees supported by funds that are managed centrally or by funds under shared management, which would facilitate their combination. The provisioning for an EU guarantee relating to a Member State compartment underpinned by other additional amounts contributed by Member States, including those made available pursuant to Regulation (EU) 2021/241, should constitute external assigned revenue. (34) A partnership between the Commission and the EIB Group should be established, drawing on the relative strengths of each partner to ensure maximum policy impact, deployment efficiency, and appropriate budgetary and risk management oversight, which should support effective and inclusive direct access to the EU guarantee. (35) The Union represented by the Commission should be in a position to participate in a capital increase of the European Investment Fund (EIF) in order to allow the EIF to continue supporting the European economy and its recovery. The main aim of the increase would be to allow the EIF to contribute to the implementation of the InvestEU Programme. The Union should be able to maintain its overall share in the EIF capital. A sufficient financial envelope to this effect should be foreseen in the Multiannual Financial Framework for 2021-2027. On 3 December 2020, the Board of Directors of the EIF decided to propose to the shareholders an increase in the authorised capital of the EIF that would result in a cash injection of EUR 1 250 000 000. The price of the new shares is based on the net asset value formula agreed among the shareholders of the EIF and consists of the paid-in part and the share premium. In accordance with Article 7 of the EIF Statutes, for each subscribed share, 20 % of the nominal value must be paid in. (36) The Commission should seek the views of other potential implementing partners along with the EIB Group on investment guidelines, the climate tracking system, the sustainability proofing guidance documents and common methodologies, as appropriate, with a view to ensuring inclusiveness and operationality until the governance bodies have been set up, after which the involvement of implementing partners should take place within the framework of the Advisory Board and the Steering Board of the InvestEU Programme. (37) The InvestEU Fund should be open to contributions from third countries that are members of the European Free Trade Association, acceding countries, candidates and potential candidates, countries covered by the European Neighbourhood Policy and other countries, in accordance with the conditions agreed between the Union and those countries, in particular in view of the positive impact of such opening on the Member States\u2019 economies. This should allow continuing cooperation with the relevant countries, where appropriate, in particular in the fields of research and innovation as well as SMEs. (38) This Regulation lays down a financial envelope for other measures of the InvestEU Programme than the provisioning of the EU guarantee, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (11), for the European Parliament and the Council during the annual budgetary procedure. (39) EUR 2 672 292 573 in current prices of the EU guarantee should be provisioned by resources from the additional allocation provided in accordance with Article 5 of and Annex II to Council Regulation (EU, Euratom) 2020/2093 (12) corresponding to an amount of EUR 1 000 000 000 in 2018 prices. An amount of EUR 63 800 000 in current prices of the total allocation to the InvestEU Advisory Hub of EUR 430 000 000 in current prices should be provided from that amount. (40) The EU guarantee of EUR 26 152 310 073 in current prices for the EU compartment is expected to mobilise more than EUR 372 000 000 000 of additional investment across the Union and should be indicatively allocated between the policy windows. (41) On 18 April 2019, the Commission declared that \u2018without prejudice to the prerogatives of the Council in the implementation of the Stability and Growth Pact (SGP), one-off contributions by Member States, either by a Member State or by national promotional banks classified in the general government sector or acting on behalf of a Member State, into thematic or multi-country investment platforms should in principle qualify as one-off measures within the meaning of Articles 5(1) and 9(1) of Council Regulation (EC) No 1466/97 (13) and Article 3(4) of Council Regulation (EC) No 1467/97 (14). In addition, without prejudice to the prerogatives of the Council in the implementation of the SGP, the Commission will consider to what extent the same treatment as for the EFSI in the context of the Commission communication on flexibility can be applied to the InvestEU Programme as the successor instrument to the EFSI with regard to one-off contributions provided by Member States in cash to finance an additional amount of the EU guarantee for the purposes of the Member State compartment.\u2019. (42) The EU guarantee underpinning the InvestEU Fund should be implemented indirectly by the Commission relying on implementing partners with outreach to financial intermediaries, where applicable, and final recipients. The selection of the implementing partners should be transparent and free from any conflict of interest. The Commission should conclude a guarantee agreement allocating guarantee capacity from the InvestEU Fund with each implementing partner to support its financing and investment operations that meet the InvestEU Fund eligibility criteria and contribute to meeting its objectives. The management of the risk related to the EU guarantee should not hamper direct access to the EU guarantee by the implementing partners. Once the EU guarantee is granted under the EU compartment to implementing partners, they should be fully responsible for the whole investment process and the due diligence related to the financing and investment operations. The InvestEU Fund should support projects that typically have a higher risk profile than the projects supported by the normal operations of the implementing partners and that could not have been carried out during the period in which the EU guarantee could be used, or could not have been carried out to the same extent, by other public or private sources without support from the InvestEU Fund. (43) The InvestEU Fund should be provided with a governance structure, the function of which should be commensurate with its sole purpose of ensuring the appropriate use of the EU guarantee, in line with ensuring the political independence of investment decisions. That governance structure should be composed of an Advisory Board, a Steering Board and a fully independent Investment Committee. The overall composition of the governance structure should strive to achieve gender balance. The governance structure should not encroach upon or interfere with the decision-making of the EIB Group or other implementing partners, and should not be a substitute for their respective governing bodies. (44) An Advisory Board consisting of representatives of the implementing partners, representatives of Member States, one expert appointed by the European Economic and Social Committee and one expert appointed by the Committee of the Regions should be established in order to exchange information and exchange views on the take-up of the financial products deployed under the InvestEU Fund and to discuss evolving needs and new products, including specific territorial market gaps. (45) In order to be able to constitute the Advisory Board from the start, the Commission should appoint the representatives of the potential implementing partners for a temporary period of one year. Thereafter, the implementing partners having signed guarantee agreements would take over that responsibility. (46) A Steering Board composed of representatives of the Commission, representatives of implementing partners and one non-voting expert appointed by the European Parliament should determine the strategic and operational guidance for the InvestEU Fund. (47) The Commission should assess the compatibility of financing and investment operations submitted by the implementing partners with all Union law and policies. The decisions on financing and investment operations should ultimately be taken by an implementing partner. (48) The Investment Committee composed of independent experts should reach a conclusion on the granting of support from the EU guarantee to financing and investment operations fulfilling the eligibility criteria of the InvestEU Fund, thereby providing external expertise in investment assessments in relation to projects. The Investment Committee should have different configurations to cover different policy areas and sectors in the best way possible. (49) An independent secretariat hosted by the Commission and answerable to the chairperson of the Investment Committee should assist the Investment Committee. (50) In selecting implementing partners for the deployment of the InvestEU Fund, the Commission should consider their ability to fulfil the objectives of the InvestEU Fund and to contribute their own resources, in order to ensure adequate geographical coverage and diversification, to crowd in private investors and to provide sufficient risk diversification and solutions to address market failures and suboptimal investment situations. Given its role under the Treaties, its capacity to operate in all Member States and the existing experience under the current financial instruments and the EFSI, the EIB Group should remain a privileged implementing partner under the InvestEU Fund\u2019s EU compartment. In addition to the EIB Group, national promotional banks and institutions should be able to offer a complementary financial product range, given that their experience and capabilities at national and regional level could be beneficial for the maximisation of the impact of public funds on the whole territory of the Union, and for ensuring a fair geographical balance of projects. The InvestEU Programme should be implemented in such a way as to promote a level playing field for smaller and younger promotional banks and institutions. Moreover, it should be possible for other international financial institutions to become implementing partners, in particular when they present a comparative advantage in terms of specific expertise and experience in certain Member States and when they present a Union majority of shareholding. It should also be possible for other entities fulfilling the criteria laid down in the Financial Regulation to become implementing partners. (51) With a view to promoting improved geographic diversification, investment platforms may be established to combine the efforts and expertise of implementing partners with other national promotional banks and institutions that have limited experience in the use of financial instruments. Such structures should be encouraged, including with available support from the InvestEU Advisory Hub. It is appropriate to bring together co-investors, public authorities, experts, education, training and research institutions, relevant social partners and representatives of the civil society and other relevant actors at Union, at national and regional levels to promote the use of investment platforms in relevant sectors. (52) The EU guarantee under the Member State compartment should be allocated to any implementing partner eligible in accordance with point (c) of Article 62(1) of the Financial Regulation, including national or regional promotional banks or institutions, the EIB, the EIF and other international financial institutions. When selecting implementing partners under the Member State compartment, the Commission should take into account the proposals made by each Member State, as reflected in the contribution agreement. In accordance with Article 154 of the Financial Regulation, the Commission is to carry out an assessment of the rules and procedures of the implementing partner to ascertain that they provide a level of protection of the financial interest of the Union equivalent to the one provided by the Commission. (53) Financing and investment operations should ultimately be decided by the implementing partner in its own name, implemented in accordance with its internal rules, policies and procedures, and accounted for in its own financial statements or, where applicable, disclosed in the notes to the financial statements. Therefore, the Commission should exclusively account for any financial liability arising from the EU guarantee and should disclose the maximum guarantee amount, including all relevant information concerning the guarantee provided. (54) Where appropriate, the InvestEU Fund should allow for the smooth, seamless and efficient blending of grants, financial instruments or both, funded by the Union budget or by other funds, such as the EU Emissions Trading System (ETS) Innovation Fund with the EU guarantee in situations where this is necessary to best underpin investments to address particular market failures or suboptimal investment situations. (55) Projects submitted by implementing partners for support under the InvestEU Programme, which include blending support from the InvestEU Fund with support from other Union programmes, should as a whole be consistent with the objectives and eligibility criteria of the relevant other Union programmes. The use of the EU guarantee should be decided under the InvestEU Programme. (56) The InvestEU Advisory Hub should support the development of a robust pipeline of investment projects in each policy window through advisory initiatives that are implemented by the EIB Group or other advisory partners, or are implemented directly by the Commission. The InvestEU Advisory Hub should promote geographic diversification with a view to contributing to the Union objectives of economic, social, and territorial cohesion and reducing regional disparities. The InvestEU Advisory Hub should pay particular attention to the aggregation of small-sized projects into larger portfolios. The Commission, the EIB Group and the other advisory partners should cooperate closely with a view to ensuring efficiency, synergies and effective geographic coverage of support across the Union, taking into account the expertise and local capacity of local implementing partners, as well as the European Investment Advisory Hub established under Regulation (EU) 2015/1017 of the European Parliament and of the Council (15). The findings of the European Court of Auditors\u2019 Special Report No 12/2020 \u2018The European Investment Advisory Hub: Launched to boost investment in the EU, the Hub\u2019s impact remains limited\u2019 (16) should be carefully considered in order to maximise the InvestEU Advisory Hub\u2019s effectiveness and impact. The InvestEU Advisory Hub should provide a central entry point for project development assistance delivered under the InvestEU Advisory Hub to public authorities and for project promoters. (57) The InvestEU Advisory Hub should be established by the Commission with the EIB Group as the main partner, building on the experience acquired through the European Investment Advisory Hub. The Commission should be responsible for the policy steer of the InvestEU Advisory Hub and for the management of the central entry point. The EIB Group should deliver advisory initiatives under the policy windows. In addition, the EIB Group should provide operational services to the Commission, including by providing input to the strategic and policy guidelines regarding advisory initiatives, mapping existing and emerging advisory initiatives, assessing advisory needs and advising the Commission on optimal ways to address these needs through existing or new advisory initiatives. (58) In order to ensure a wide geographic outreach of the advisory services across the Union and to successfully leverage local knowledge about the InvestEU Fund, a local presence of the InvestEU Advisory Hub should be ensured, where needed, taking into account existing support schemes and the presence of local partners, with a view to providing tangible, proactive, tailor-made assistance on the ground. In order to facilitate the provision of advisory support at local level and to ensure efficiency, synergies and effective geographic coverage of support across the Union, the InvestEU Advisory Hub should cooperate with national promotional banks and institutions, and should benefit from and make use of their expertise. (59) The InvestEU Advisory Hub should provide advisory support to small-sized projects and projects for start-ups, especially when start-ups seek to protect their research and innovation investments by obtaining intellectual property titles, such as patents, taking into account the existence of other services able to cover such actions and seeking synergies with those services. (60) In the context of the InvestEU Fund, there is a need to provide support for project development and capacity building to develop the organisational capacities and market development activities needed to originate quality projects. Such support should also target financial intermediaries that are key to help SMEs access financing and realise their full potential. Moreover, the aim of the advisory support is to create the conditions for the expansion of the potential number of eligible recipients in nascent market segments, in particular where the small size of individual projects considerably raises the transaction cost at the project level, such as for the social finance ecosystem, including philanthropic organisations, or for the cultural and creative sectors. The capacity-building support should be complementary and in addition to actions taken under other Union programmes that cover specific policy areas. An effort should also be made to support the capacity building of potential project promoters, in particular local organisations and authorities. (61) The InvestEU Portal should be established to provide for an easily accessible and user-friendly project database to promote visibility of investment projects searching for financing with enhanced focus on the provision of a possible pipeline of investment projects, compatible with Union law and policies, to the implementing partners. (62) In accordance with Council Regulation (EU) 2020/2094 (17) and within the limits of resources allocated therein, recovery and resilience measures under the InvestEU Programme should be carried out to address the unprecedented impact of the COVID-19 crisis. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation (EU) 2020/2094. (63) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (18), the InvestEU Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators, as a basis for evaluating the effects of the InvestEU Programme on the ground. (64) A solid monitoring framework that is based on output, outcome and impact indicators should be implemented to track progress towards the Union\u2019s objectives. In order to ensure accountability to the Union\u2019s citizens, the Commission should report annually to the European Parliament and the Council on the progress, impact and operations of the InvestEU Programme. (65) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union (TFEU) apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (66) The Financial Regulation applies to the InvestEU Programme. It lays down rules on the implementation of the Union budget, including the rules on budgetary guarantees. (67) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (19) and Council Regulations (EC, Euratom) No 2988/95 (20), (Euratom, EC) No 2185/96 (21) and (EU) 2017/1939 (22), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (23). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (68) Third countries which are members of the European Economic Area (EEA) may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (24), which provides for the implementation of the programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. (69) Pursuant to Council Decision 2013/755/EU (25), individuals and entities established in overseas countries or territories are eligible for funding subject to the rules and objectives of the InvestEU Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (70) In order to supplement the non-essential elements of this Regulation with investment guidelines and with a scoreboard of indicators, to facilitate the prompt and flexible adaptation of the performance indicators and to adjust the provisioning rate, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of drawing-up investment guidelines for the financing and investment operations under different policy windows, of the scoreboard, of the amendment of Annex III to this Regulation to review or complement the indicators and of the adjustment of the provisioning rate. In line with the principle of proportionality, such investment guidelines should include adequate provisions to avoid undue administrative burden. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (71) Financing and investment operations signed or entered into by an implementing partner during the period from 1 January 2021 until the signature of their respective guarantee agreements should be eligible for the EU guarantee provided that such operations are indicated in the guarantee agreement, pass the policy check or receive a favourable opinion within the framework of the procedure provided for in Article 19 of Protocol No 5 on the Statute of the European Investment Bank annexed to the Treaty on European Union (TEU) and the TFEU (the EIB Statute), and are in both cases approved by the Investment Committee. (72) In order to optimise the use of budgetary resources, a combination of relevant portfolios of financial instruments established under the 2014-2020 Multiannual Financial Framework and the EU guarantee under Regulation (EU) 2015/1017 with the EU guarantee under this Regulation should be possible. The increased risk bearing capacity established by such combination should enhance the efficiency of the EU guarantee under this Regulation and allow for more support to final recipients. The modalities of the combination should be defined in the guarantee agreement between the Commission and the EIB or the EIF. The conditions of the combination should be consistent with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (26). (73) Since the objectives of this Regulation, namely to address Union-wide and Member State specific market failures and suboptimal investment situations and provide for Union-wide market testing of innovative financial products designed to address new or complex market failures or suboptimal investment situations and of systems to spread such products, cannot be sufficiently achieved by the Member States, but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (74) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the multi-annual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject matter This Regulation establishes the InvestEU Fund, which shall provide for an EU guarantee to support financing and investment operations carried out by the implementing partners that contribute to objectives of the Union\u2019s internal policies. This Regulation also establishes an advisory support mechanism to provide support for the development of investable projects and access to financing and to provide related capacity building assistance (the \u2018InvestEU Advisory Hub\u2019). It further establishes a database granting visibility to projects for which project promoters seek financing and which provides investors with information about investment opportunities (the \u2018InvestEU Portal\u2019). This Regulation establishes the objectives of the InvestEU Programme, its budget and the amount of the EU guarantee for the period 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018InvestEU Programme\u2019 means the InvestEU Fund, the InvestEU Advisory Hub, the InvestEU Portal and blending operations, collectively; (2) \u2018EU guarantee\u2019 means an overall irrevocable, unconditional and on demand budgetary guarantee provided by the Union budget under which the budgetary guarantees in accordance with Article 219(1) of the Financial Regulation take effect through the entry into force of individual guarantee agreements with implementing partners; (3) \u2018policy window\u2019 means a targeted area for support by the EU guarantee as laid down in Article 8(1); (4) \u2018compartment\u2019 means a part of the EU guarantee defined in terms of the origin of the resources backing it; (5) \u2018blending operation\u2019 means an operation supported by the Union budget that combines non-repayable forms of support, repayable forms of support, or both, from the Union budget with repayable forms of support from development or other public finance institutions, or from commercial finance institutions and investors; for the purposes of this definition, Union programmes financed from sources other than the Union budget, such as the EU ETS Innovation Fund, may be assimilated to Union programmes financed by the Union budget; (6) \u2018EIB Group\u2019 means the EIB, its subsidiaries and other entities established in accordance with Article 28(1) of Protocol No 5 on the Statute of the European Investment Bank annexed to the TEU and the TFEU (the EIB Statute); (7) \u2018financial contribution\u2019 means a contribution from an implementing partner in the form of own risk-taking capacity that is provided on a pari passu basis with the EU guarantee or in another form that allows an efficient implementation of the InvestEU Programme while ensuring appropriate alignment of interest; (8) \u2018contribution agreement\u2019 means a legal instrument whereby the Commission and one or more Member States specify the conditions of the EU guarantee under the Member State compartment, as laid down in Article 10; (9) \u2018financial product\u2019 means a financial mechanism or arrangement under the terms of which the implementing partner provides direct or intermediated financing to final recipients using any of the types of financing referred to in Article 16; (10) \u2018financing and investment operations\u2019 or \u2018financing or investment operations\u2019 means operations to provide finance directly or indirectly to final recipients through financial products, carried out by an implementing partner in its own name, provided by the implementing partner in accordance with its internal rules, policies and procedures and accounted for in the implementing partner\u2019s financial statements or, where applicable, disclosed in the notes to those financial statements; (11) \u2018funds under shared management\u2019 means funds that provide for the possibility of allocating a portion of those funds to the provisioning for a budgetary guarantee under the Member State compartment of the InvestEU Fund, namely the European Regional Development Fund (ERDF) and the Cohesion Fund to be established by a Regulation of the European Parliament and of the Council on the European Regional Development Fund and on the Cohesion Fund for the years 2021-2027, the European Social Fund Plus (ESF+) to be established by a Regulation of the European Parliament and of the Council on the European Social Fund Plus (ESF+) (the \u2018ESF+ Regulation for 2021-2027\u2019), the European Maritime, Fisheries and Aquaculture Fund (EMFAF) to be established by a Regulation of the European Parliament and of the Council on the European Maritime, Fisheries and Aquaculture Fund and repealing Regulation (EU) No 508/2014 and the European Agriculture Fund for Rural Development (EAFRD) to be established by a Regulation of the European Parliament and of the Council establishing rules on support for strategic plans to be drawn up by Member States under the Common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulation (EU) No 1305/2013 of the European Parliament and of the Council and Regulation (EU) No 1307/2013 of the European Parliament and of the Council (the \u2018CAP Strategic Plans Regulation\u2019); (12) \u2018guarantee agreement\u2019 means a legal instrument whereby the Commission and an implementing partner specify the conditions for proposing financing and investment operations in order for them to be granted the benefit of the EU guarantee, for providing the EU guarantee for those operations and for implementing them in accordance with this Regulation; (13) \u2018implementing partner\u2019 means an eligible counterpart such as a financial institution or other financial intermediary with whom the Commission has concluded a guarantee agreement; (14) \u2018important project of common European interest\u2019 means a project that fulfils all the criteria laid down in the Commission Communication on Criteria for the analysis of the compatibility with the internal market of State aid to promote the execution of important projects of common European interest or any subsequent revision of that Communication; (15) \u2018advisory agreement\u2019 means a legal instrument whereby the Commission and the advisory partner specify the conditions for the implementation of the InvestEU Advisory Hub; (16) \u2018advisory initiative\u2019 means technical assistance and advisory services that support investment, including capacity building activities, provided by advisory partners, by external service providers contracted by the Commission, or by executive agencies; (17) \u2018advisory partner\u2019 means an eligible counterpart such as a financial institution or other entity with whom the Commission has concluded an advisory agreement for the purpose of implementing one or more advisory initiatives, other than advisory initiatives implemented through external service providers contracted by the Commission or through executive agencies; (18) \u2018investment platform\u2019 means a special purpose vehicle, managed account, contract-based co-financing or risk-sharing arrangement or an arrangement established by any other means by which entities channel a financial contribution in order to finance a number of investment projects, and which may include: (a) a national or sub-national platform that groups together several investment projects on the territory of a given Member State; (b) a cross-border, multi-country, regional or macro-regional platform that groups together partners from several Member States, regions or third countries interested in investment projects in a given geographic area; (c) a thematic platform that groups together investment projects in a given sector; (19) \u2018microfinance\u2019 means microfinance as defined in the relevant provisions of the ESF+ Regulation for 2021-2027; (20) \u2018national promotional bank or institution\u2019 means a legal entity that carries out financial activities on a professional basis which has been given mandate by a Member State or a Member State\u2019s entity at central, regional or local level to carry out development or promotional activities; (21) \u2018small and medium-sized enterprise\u2019 or \u2018SME\u2019 means a micro, small or medium-sized enterprise within the meaning of the Annex to Commission Recommendation 2003/361/EC (27); (22) \u2018small mid-cap company\u2019 means an entity that is not an SME and that employs up to 499 employees; (23) \u2018social enterprise\u2019 means a social enterprise as defined in the relevant provisions of the ESF+ Regulation for 2021-2027. Article 3 Objectives of the InvestEU Programme 1. The general objective of the InvestEU Programme is to support the policy objectives of the Union by means of financing and investment operations that contribute to: (a) the competitiveness of the Union, including research, innovation and digitisation; (b) growth and employment in the Union economy, the sustainability of the Union economy and its environmental and climate dimension contributing to the achievement of the SDGs and the objectives of the Paris Agreement and to the creation of high-quality jobs; (c) the social resilience, inclusiveness and innovativeness of the Union; (d) the promotion of scientific and technological advances, of culture, education and training; (e) the integration of Union capital markets and the strengthening of the internal market, including solutions to address the fragmentation of Union capital markets, diversify sources of financing for Union enterprises and promote sustainable finance; (f) the promotion of economic, social and territorial cohesion; or (g) the sustainable and inclusive recovery of the Union economy after the COVID-19 crisis, including by providing capital support for SMEs that were negatively affected by the COVID-19 crisis and were not already in difficulty in State aid terms at the end of 2019, upholding and strengthening existing strategic value chains of tangible or intangible assets, developing new ones, and maintaining and reinforcing activities of strategic importance to the Union, including important projects of common European interest, in relation to critical infrastructure, whether physical or virtual, transformative technologies, game-changing innovations and inputs to businesses and consumers and supporting a sustainable transition. 2. The InvestEU Programme has the following specific objectives: (a) supporting financing and investment operations related to sustainable infrastructure in the areas referred to in point (a) of Article 8(1); (b) supporting financing and investment operations related to research, innovation and digitisation, including support for the scaling up of innovative companies and the rolling out of technologies to market, in the areas referred to in point (b) of Article 8(1); (c) increasing the access to and the availability of finance for SMEs and for small mid-cap companies and to enhance the global competitiveness of such SMEs; (d) increasing access to and the availability of microfinance and finance for social enterprises, to support financing and investment operations related to social investment, competences and skills, and to develop and consolidate social investment markets, in the areas referred to in point (d) of Article 8(1). Article 4 Budget and amount of the EU guarantee 1. The EU guarantee for the purposes of the EU compartment referred to in point (a) of Article 9(1) shall be EUR 26 152 310 073 in current prices. It shall be provisioned at the rate of 40 %. The amount referred to in point (a) of the first subparagraph of Article 35(3) shall be also taken into account for contributing to the provisioning resulting from that provisioning rate. An additional amount of the EU guarantee may be provided for the purposes of the Member State compartment referred to in point (b) of Article 9(1) of this Regulation, subject to the allocation by Member States, pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the instrument for financial support for border management and visa (the \u2018Common Provisions Regulation for 2021-2027\u2019) and the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation, of the corresponding amounts. An additional amount of the EU guarantee may also be provided in the form of cash or guarantee by Member States for the purposes of the Member State compartment. The amount provided in cash shall constitute an external assigned revenue in accordance with the second sentence of Article 21(5) of the Financial Regulation. The contributions from third countries referred to in Article 5 of this Regulation shall also increase the EU guarantee referred to in the first subparagraph, providing a provisioning in cash in full in accordance with Article 218(2) of the Financial Regulation. 2. An amount of EUR 14 825 000 000 in current prices of the amount referred to in the first subparagraph of paragraph 1 of this Article shall be allocated for operations implementing measures referred to in Article 1 of Regulation (EU) 2020/2094 for the objectives referred to in Article 3(2) of this Regulation. An amount of EUR 11 327 310 073 in current prices of the amount referred to in the first subparagraph of paragraph 1 of this Article shall be allocated for the objectives referred to in Article 3(2). The amounts referred to in the first subparagraph of this paragraph shall only be available as of the date referred to in Article 3(3) of Regulation (EU) 2020/2094. The indicative distribution of the EU guarantee for the purposes of the EU compartment is set out in Annex I to this Regulation. Where appropriate, the Commission may depart from the amounts referred to in Annex I by up to 15 % for each objective referred to in points (a) to (d) of Article 3(2). The Commission shall inform the European Parliament and the Council of any such departure. 3. The financial envelope for the implementation of the measures provided in Chapters VI and VII shall be EUR 430 000 000 in current prices. 4. The amount referred to in paragraph 3 may also be used for technical and administrative assistance for the implementation of the InvestEU Programme, such as preparatory, monitoring, control, audit and evaluation activities, including for corporate information technology systems. Article 5 Third countries associated to the InvestEU Fund The EU compartment of the InvestEU Fund referred to in point (a) of Article 9(1) of this Regulation and each of the policy windows referred to in Article 8(1) of this Regulation may receive contributions from the following third countries for the purpose of participation in certain financial products pursuant to Article 218(2) of the Financial Regulation: (a) members of the European Free Trade Association (EFTA) which are members of the EEA, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country any decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. The contributions referred to in point (d)(ii) of the first paragraph of this Article shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. Article 6 Implementation and forms of Union funding 1. The EU guarantee shall be implemented in indirect management with bodies referred to in points (c)(ii), (c)(iii), (c)(v) and (c)(vi) of Article 62(1) of the Financial Regulation. Other forms of Union funding under this Regulation shall be implemented in direct or indirect management in accordance with the Financial Regulation, including grants implemented in accordance with Title VIII of the Financial Regulation and blending operations implemented in accordance with this Article as smoothly as possible, in a manner that ensures efficient and coherent support for Union policies. 2. Financing and investment operations covered by the EU guarantee which form part of the blending operation combining support under this Regulation with support provided under one or more other Union programmes or covered by the EU ETS Innovation Fund shall: (a) be consistent with the policy objectives and comply with the eligibility criteria set out in the rules of the Union programme under which the support is decided; (b) comply with this Regulation. 3. Blending operations that include a financial instrument that is fully financed by other Union programmes or by the EU ETS Innovation Fund without the use of the EU guarantee under this Regulation shall be consistent with the policy objectives and comply with the eligibility criteria set out in the rules of the Union programme under which the support is provided. 4. In accordance with paragraph 2 of this Article, the non-repayable forms of support and financial instruments from the Union budget forming part of the blending operation referred to in paragraphs 2 and 3 of this Article shall be decided under the rules of the relevant Union programme and shall be implemented within the blending operation in accordance with this Regulation and with Title X of the Financial Regulation. The reporting relating to such blending operations shall also cover their consistency with the policy objectives and eligibility criteria set out in the rules of the Union programme under which the support is decided as well as their compliance with this Regulation. Article 7 Combination of portfolios 1. Support from the EU guarantee under this Regulation, Union support provided through the financial instruments established by the programmes in the programming period 2014-2020 and Union support from the EU guarantee established by Regulation (EU) 2015/1017 may be combined in financial products to be implemented by the EIB or the EIF under this Regulation. 2. By way of derogation from Article 19(2) and the second subparagraph of Article 16(1), the EU guarantee under this Regulation may also cover losses referred to in Article 19(2) in relation to the entire portfolio of financing and investment operations supported by the financial products referred to in paragraph 1 of this Article. Notwithstanding the objectives of the financial instruments referred to in paragraph 1, the provisions made to cover the financial liabilities arising from financial instruments referred to in paragraph 1 may be used to cover losses in relation to the entire portfolio of financing and investment operations supported by the financial products referred to in paragraph 1. 3. Losses, revenues and repayments from financial products as referred to in paragraph 1, as well as potential recoveries, shall be attributed pro rata between the financial instruments and EU guarantees referred to in that paragraph providing the combined Union support to that financial product. 4. The terms and conditions of the financial products referred to in paragraph 1 of this Article, including the respective pro rata shares of losses, revenues, repayments and recoveries, shall be set out in the guarantee agreement referred to in Article 17. CHAPTER II InvestEU Fund Article 8 Policy windows 1. The InvestEU Fund shall operate through the following four policy windows that shall address market failures or suboptimal investment situations within their specific scope: (a) a sustainable infrastructure policy window which comprises sustainable investment in the areas of transport, including multimodal transport, road safety, including in accordance with the Union objective of eliminating fatal road accidents and serious injuries by 2050, the renewal and maintenance of rail and road infrastructure, energy, in particular renewable energy, energy efficiency in accordance with the 2030 energy framework, buildings renovation projects focused on energy savings and the integration of buildings into a connected energy, storage, digital and transport systems, improving interconnection levels, digital connectivity and access, including in rural areas, supply and processing of raw materials, space, oceans, water, including inland waterways, waste management in accordance with the waste hierarchy and the circular economy, nature and other environment infrastructure, cultural heritage, tourism, equipment, mobile assets and the deployment of innovative technologies that contribute to the environmental or climate resilience or social sustainability objectives of the Union and that meet the environmental or social sustainability standards of the Union; (b) a research, innovation and digitisation policy window which comprises research, product development and innovation activities, the transfer of technologies and research results to the market to support market enablers and cooperation between enterprises, the demonstration and deployment of innovative solutions and support for the scaling up of innovative companies, as well as digitisation of Union industry; (c) an SME policy window which comprises access to and the availability of finance primarily for SMEs, including for innovative SMEs and SMEs operating in the cultural and creative sectors, as well as for small mid-cap companies; (d) a social investment and skills policy window, which comprises microfinance, social enterprise finance, social economy and measures to promote gender equality, skills, education, training and related services, social infrastructure, including health and educational infrastructure and social and student housing, social innovation, health and long-term care, inclusion and accessibility, cultural and creative activities with a social goal, and the integration of vulnerable people, including third country nationals. 2. A just transition scheme shall be established horizontally across all policy windows. That scheme shall comprise investments that address social, economic and environmental challenges deriving from the transition process towards the achievement of the Union\u2019s 2030 climate target and its target of achieving climate neutrality by 2050, as well as benefit territories identified in a just transition plan prepared by a Member State in accordance with the relevant provisions of the Just Transition Fund Regulation. 3. All policy windows may include strategic investments including important projects of common European interest to support final recipients whose activities are of strategic importance to the Union, in particular in view of the green and digital transitions, of enhanced resilience and of strengthening strategic value chains. In the case of strategic investments in defence and space sectors and in cybersecurity, as well as in specific types of projects with actual and direct security implications in critical sectors, the investment guidelines adopted in accordance with paragraph 9 of this Article (the \u2018investment guidelines\u2019) shall set out limitations with respect to final recipients controlled by a third country or third country entities and final recipients having their executive management outside the Union with a view to protecting the security of the Union and its Member States. Those limitations shall be set out in line with the principles concerning eligible entities set out in the relevant provisions of a Regulation of the European Parliament and of the Council establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 and in the relevant provisions of a Regulation of the European Parliament and of the Council establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013, (EU) No 377/2014 and Decision No 541/2014/EU. The investment guidelines shall set out any necessary requirements relating to the control and executive management of final recipients for other areas, and to the control of intermediaries, in the light of any applicable public order or security considerations. Taking account of those requirements, the Steering Board shall set out any necessary additional requirements. 4. Where a financing or investment operation proposed to the Investment Committee falls under more than one policy window, it shall be attributed to the policy window under which its main objective or the main objective of most of its sub-projects falls, unless the investment guidelines provide otherwise. 5. Financing and investment operations shall be screened to determine whether they have an environmental, climate or social impact. If those operations have such an impact they shall be subject to climate, environmental and social sustainability proofing with a view to minimising detrimental impacts and to maximising benefits to the climate, environment and social dimensions. For that purpose, project promoters that request financing shall provide adequate information based on the guidance referred to in paragraph 6. Projects below a certain size specified in the guidance shall be excluded from the proofing. Projects that are inconsistent with the climate objectives shall not be eligible for support under this Regulation. In the event that the implementing partner concludes that no sustainability proofing is to be carried out, it shall provide a justification to the Investment Committee. 6. The Commission shall develop sustainability guidance that, in accordance with Union environmental and social objectives and standards and, taking appropriate account of the principle of \u2018do no significant harm\u2019 allows for: (a) as regards adaptation, ensuring resilience to the potential adverse impacts of climate change through a climate vulnerability and risk assessment, including through relevant adaptation measures, and, as regards mitigation, integrating the cost of greenhouse gas emissions and the positive effects of climate mitigation measures in the cost-benefit analysis; (b) accounting for the consolidated impact of projects in terms of the principal components of natural capital, namely air, water, land and biodiversity; (c) estimating the social impact of projects, including on gender equality, on the social inclusion of certain areas or populations and on the economic development of areas and sectors affected by structural challenges such as the need to decarbonise the economy; (d) identifying projects that are inconsistent with the achievement of climate objectives; (e) providing implementing partners with guidance for the purpose of the screening provided for under paragraph 5. 7. Implementing partners shall provide the information necessary to allow the tracking of investment that contributes to meeting the Union objectives on climate and environment, on the basis of guidance to be provided by the Commission. 8. Implementing partners shall apply a target of at least 60 % of the investment under the sustainable infrastructure policy window contributing to meeting the Union objectives on climate and environment. The Commission, together with implementing partners, shall seek to ensure that the part of the EU guarantee used for the sustainable infrastructure policy window is distributed with the aim of achieving a balance between the different areas referred to in point (a) of paragraph 1. 9. The Commission is empowered to adopt delegated acts in accordance with Article 34 in order to supplement this Regulation by defining the investment guidelines for each of the policy windows. The investment guidelines shall also set out the arrangements for the implementation of the just transition scheme, as referred to in paragraph 2 of this Article. The investment guidelines shall be prepared in close dialogue with the EIB Group and other potential implementing partners. 10. For strategic financing and investment operations in defence and space sectors and in cybersecurity, the investment guidelines may set out limitations with respect to transfer and licensing of intellectual property rights to critical technologies and technologies instrumental to safeguarding the security of the Union and its Member States while respecting Member State competence within export control. 11. The Commission shall make the information on the application and interpretation of the investment guidelines available to the implementing partners, the Investment Committee and the advisory partners. Article 9 Compartments 1. The policy windows referred to in Article 8(1) shall consist of an EU compartment and a Member State compartment. Those compartments shall address market failures or suboptimal investment situations as follows: (a) the EU compartment shall address any of the following situations: (i) market failures or suboptimal investment situations related to Union policy priorities; (ii) Union-wide or Member State specific market failures or suboptimal investment situations; or (iii) market failures or suboptimal investment situations, which require the development of innovative financial solutions and market structures, in particular new or complex market failures or suboptimal investment situations; (b) the Member State compartment shall address specific market failures or suboptimal investment situations in one or several regions or Member States to deliver the policy objectives of the contributing funds under shared management or of the additional amount provided by a Member State under the third subparagraph of Article 4(1), in particular to strengthen economic, social and territorial cohesion in the Union by addressing imbalances between its regions. 2. Where appropriate, the compartments referred to in paragraph 1 shall be used in a complementary manner to support a given financing or investment operation, including by combining support from both compartments. Article 10 Specific provisions applicable to the Member State compartment 1. Amounts allocated by a Member State on a voluntary basis pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation or amounts provided in cash in accordance with the third subparagraph of Article 4(1) of this Regulation shall be used for the provisioning for the part of the EU guarantee under the Member State compartment covering financing and investment operations in the Member State concerned or for the possible contribution to the InvestEU Advisory Hub. Those amounts shall be used to contribute to the achievement of the policy objectives specified in the Partnership Agreement referred to in the provisions on the preparation and submission of the Partnership Agreement laid down in the Common Provisions Regulation for 2021-2027, in the programmes or in the CAP Strategic Plan which contribute to the InvestEU Programme, in order to implement relevant measures set out in the recovery and resilience plan established under Regulation (EU) 2021/241 or, in other cases, for the purposes laid down in the contribution agreement, depending on the origin of the amount contributed. 2. The establishment of the part of the EU guarantee under the Member State compartment shall be subject to the conclusion of a contribution agreement between a Member State and the Commission. The fourth subparagraph of this paragraph and paragraph 5 of this Article shall not apply to the additional amount provided by a Member State under the third subparagraph of Article 4(1). The provisions in this Article relating to amounts allocated pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation are not applicable to a contribution agreement concerning an additional amount by a Member State, referred to in the third subparagraph of Article 4(1) of this Regulation. The Member State and the Commission shall conclude a contribution agreement or an amendment to it within four months following the Commission Decision approving the Partnership Agreement pursuant to the provisions on the approval of the Partnership Agreement laid down in the Common Provisions Regulation for 2021-2027 or the CAP Strategic Plan under the CAP Strategic Plans Regulation or simultaneously to the Commission Decision amending a programme in accordance with the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or a CAP Strategic Plan in accordance with the provisions on the amendment to the CAP Strategic Plan laid down in the CAP Strategic Plans Regulation. Two or more Member States may conclude a joint contribution agreement with the Commission. By way of derogation from Article 211(1) of the Financial Regulation, the provisioning rate of the EU guarantee under the Member State compartment shall be set at 40 % and may be adjusted downwards or upwards in each contribution agreement to take account of the risks attached to the financial products intended to be used. 3. The contribution agreement shall at least contain the following elements: (a) the overall amount of the part of the EU guarantee under the Member State compartment pertaining to the Member State concerned, its provisioning rate, the amount of the contribution from funds under shared management or provided in accordance with the third subparagraph of Article 4(1), the constitution phase of the provisioning and the amount of the resulting contingent liability to be covered by a back-to-back guarantee provided by the Member State concerned; (b) the Member State strategy, consisting of the financial products and their minimum leverage, the geographical coverage, including regional coverage if necessary, types of projects, the investment period and, where applicable, the categories of final recipients and of eligible intermediaries; (c) the potential implementing partner or partners proposed in accordance with fourth subparagraph of Article 15(1) and the obligation of the Commission to inform the Member State concerned of the implementing partner or partners selected; (d) any contribution from funds under shared management or from amounts provided in accordance with the third subparagraph of Article 4(1) to the InvestEU Advisory Hub; (e) the obligations to provide annual reports to the Member State, including reporting on the relevant indicators related to the policy objectives covered in the Partnership Agreement, programme, CAP Strategic Plan or in the recovery and resilience plans and referred to in the contribution agreement; (f) provisions on the remuneration for the part of the EU guarantee under the Member State compartment; (g) any combination with resources under the EU compartment in accordance with Article 9(2), including in a layered structure to achieve better risk coverage. 4. The contribution agreements shall be implemented by the Commission through guarantee agreements concluded with implementing partners in accordance with Article 17 and advisory agreements concluded with advisory partners in accordance with the second subparagraph of Article 25(1). Where no guarantee agreement has been concluded within nine months from the conclusion of the contribution agreement, the contribution agreement shall be terminated or prolonged by mutual agreement. Where the amount of a contribution agreement has not been fully committed under one or more guarantee agreements within nine months from the conclusion of the contribution agreement, that amount shall be amended accordingly. The unused amount of provisioning attributable to amounts allocated by Member States pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation shall be re-used in accordance with those Regulations. The unused amount of provisioning attributable to amounts allocated by a Member State under the third subparagraph of Article 4(1) of this Regulation shall be paid back to the Member State. Where a guarantee agreement has not been duly implemented within the period specified in the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or in the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation, or, in the case of a guarantee agreement related to amounts provided in accordance with the third subparagraph of Article 4(1) of this Regulation, in the relevant contribution agreement, the contribution agreement shall be amended. The unused amount of provisioning attributable to amounts allocated by Member States pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation shall be re-used in accordance with those Regulations. The unused amount of provisioning attributable to amounts allocated by a Member State under the third subparagraph of Article 4(1) of this Regulation shall be paid back to the Member State. 5. The following rules shall apply to the provisioning for the part of the EU guarantee under the Member State compartment established by a contribution agreement: (a) after the constitution phase referred to in point (a) of paragraph 3 of this Article, any annual surplus of provisions, calculated by comparing the amount of provisions required by the provisioning rate set in the contribution agreement and the actual amount of provisions, shall be re-used pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 and to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation; (b) by way of derogation from Article 213(4) of the Financial Regulation, after the constitution phase referred to in point (a) of paragraph 3 of this Article, the provisioning shall not give rise to annual replenishments during the availability of that part of the EU guarantee under the Member State compartment; (c) the Commission shall immediately inform the Member State where the level of provisions for that part of the EU guarantee falls below 20 % of the initial provisioning as a result of calls on that part of the EU guarantee under the Member State compartment; (d) if the level of provisions for that part of the EU guarantee under the Member State compartment reaches 10 % of the initial provisioning, the Member State concerned shall provide up to 5 % of the initial provisioning to the common provisioning fund referred to in Article 212 of the Financial Regulation upon request by the Commission. 6. In relation to amounts referred to in the third subparagraph of Article 4(1), the management of the annual surpluses and replenishments after the constitution phase shall be defined in the contribution agreement. CHAPTER III Partnership between the Commission and the EIB Group Article 11 Scope of the partnership 1. The Commission and the EIB Group shall form a partnership under this Regulation with the objective of supporting the implementation of the InvestEU Programme and fostering consistency, inclusivity, additionality, and efficient deployment. In accordance with this Regulation and as further specified in the agreements referred to in paragraph 3, the EIB Group: (a) shall implement the portion of the EU guarantee specified in Article 13(4); (b) shall support the implementation of the EU compartment of the InvestEU Fund, and, where applicable, the Member State compartment, in particular by: (i) contributing, together with potential implementing partners, to the investment guidelines in accordance with Article 8(9), contributing to the design of the Scoreboard in accordance with Article 22 and contributing to other documents that set out the operational guidance of the InvestEU Fund; (ii) defining, together with the Commission and potential implementing partners, the risk methodology and risk mapping system that relate to the financing and investment operations of the implementing partners in order to allow such operations to be assessed on a common rating scale; (iii) at the request of the Commission and in agreement with the potential implementing partner concerned, carrying out an assessment of the systems of that potential implementing partner and providing targeted technical advice on those systems, where and to the extent required by the conclusions of the audit of the pillar assessment in view of the implementation of the financial products envisaged by that potential implementing partner; (iv) providing a non-binding opinion on the banking-related aspects, in particular on the financial risk and financial terms related to the portion of the EU guarantee to be allocated to the implementing partner, other than to the EIB Group, as defined in the guarantee agreement to be concluded with that implementing partner; (v) carrying out simulations and projections of the financial risk and remuneration of the aggregate portfolio on the basis of assumptions agreed with the Commission; (vi) measuring the financial risk of the aggregate portfolio and providing financial reports on the aggregate portfolio; and (vii) providing restructuring and recovery services as set out in the agreement referred to in point (b) of paragraph 3 of this Article to the Commission at the request of the Commission and in agreement with the implementing partner in accordance with point (g) of Article 17(2) where that implementing partner is no longer responsible for pursuing restructuring and recovery activities under the relevant guarantee agreement; (c) may provide capacity building as referred to in point (h) of Article 25(2) to a national promotional bank or institution and other services, in relation to the implementation of financial products supported by the EU guarantee if requested by that national promotional bank or institution; (d) shall, in relation to the InvestEU Advisory Hub: (i) be allocated an amount of up to EUR 300 000 000 for the advisory initiatives referred to in Article 25 and operational tasks referred to in point (ii) of this point out of the financial envelope referred to in Article 4(3); (ii) advise the Commission and perform operational tasks set out in the agreement referred to in point (c) of paragraph 3, by: \u2014 providing support to the Commission in the design, the establishment and operation of the InvestEU Advisory Hub; \u2014 providing an assessment of requests for advisory support that the Commission does not consider to fall under existing advisory initiatives, with a view to supporting the allocation decision of the Commission in relation to advisory requests received under the central point of entry defined in point (a) of Article 25(2); \u2014 providing support to national promotional banks and institutions by providing capacity building referred to in point (h) of Article 25(2) in relation to the development of their advisory capabilities to enable them to participate in advisory initiatives, at the request of such banks or institutions; \u2014 at the request of the Commission and of a potential advisory partner, and subject to the agreement of the EIB Group, concluding on behalf of the Commission an agreement with the advisory partner for the delivery of advisory initiatives. The EIB Group shall ensure that its tasks as referred to in point (d)(ii) of the first subparagraph are conducted entirely independently from its role as an advisory partner. As appropriate, the Commission shall engage with the implementing partner on the basis of the findings of the opinion of the EIB Group referred to in point (b)(iv) of the first subparagraph. The Commission shall inform the EIB Group of the outcome of its decision-making. 2. The banking-related information transmitted to the EIB Group by the Commission in accordance with points (b)(ii), (b)(iv), (b)(v) and (b)(vi) of the first subparagraph of paragraph 1 shall be limited to information strictly necessary for the EIB Group to fulfil its obligations under those points. The Commission, in close dialogue with the EIB Group and potential implementing partners, shall define the nature and scope of that banking-related information, taking into account the requirements for the sound financial management of the EU guarantee, the legitimate interests of the implementing partner regarding commercially sensitive information and the needs of the EIB Group in meeting its obligations under those points. 3. The terms of the partnership shall be laid down in agreements, including: (a) on the granting and implementation of the portion of the EU guarantee specified in Article 13(4): (i) a guarantee agreement between the Commission and the EIB Group; or (ii) separate guarantee agreements between the Commission and the EIB and its subsidiaries or other entities established in accordance with Article 28(1) of the EIB Statute, as applicable; (b) an agreement between the Commission and the EIB Group in relation to points (b) and (c) of the first subparagraph of paragraph 1; (c) an agreement between the Commission and the EIB Group in relation to the InvestEU Advisory Hub; (d) service agreements between the EIB Group and national promotional banks and institutions concerning capacity building and other services provided under point (c) of the first subparagraph of paragraph 1. 4. Without prejudice to Articles 18(3) and 25(4) of this Regulation, the costs incurred by the EIB Group in the performance of tasks referred to in points (b) and (c) of the first subparagraph of paragraph 1 of this Article shall be in accordance with the terms of the agreement referred to in point (b) of paragraph 3 of this Article and may be covered from the repayments or revenues attributable to the EU guarantee, or from the provisioning, in accordance with Article 211(4) and (5) of the Financial Regulation, or may be charged to the financial envelope referred to in Article 4(3) of this Regulation, upon justification of those costs by the EIB Group, subject to an overall cap of EUR 7 000 000. 5. The costs incurred by the EIB Group for the performance of the operational tasks referred to in point (d)(ii) of the first subparagraph of paragraph 1 shall be fully covered by and paid from the amount referred to in point (d)(i) of the first subparagraph of paragraph 1, upon justification of those costs by the EIB Group, subject to an overall cap of EUR 10 000 000. Article 12 Conflicts of interest 1. Within the framework of the partnership as referred to in Article 11, the EIB Group shall take all necessary measures and precautions to avoid conflicts of interest with other implementing partners, including by putting in place a dedicated and independent team for the tasks referred to in points (b)(iii) to (vi) of the first subparagraph of Article 11(1). That team shall be subject to strict confidentiality rules, which shall continue to apply to members of the team after they have left the team. 2. The EIB Group and other implementing partners shall inform the Commission without delay of any situation that constitutes a conflict of interest or is likely to lead to a conflict of interest. In the event of doubt, the Commission shall determine whether a conflict of interest exists and shall inform the EIB Group of its conclusion. In the event of a conflict of interest, the EIB Group shall take appropriate measures. The EIB Group shall inform the Steering Board of those measures and their results. 3. The EIB Group shall take the necessary precautions to avoid situations in which a conflict of interest could arise in the implementation of the InvestEU Advisory Hub, in particular in relation to its operational tasks in its role of supporting the Commission as referred to in point (d)(ii) of the first subparagraph of Article 11(1). In the event of a conflict of interest, the EIB Group shall take appropriate measures. CHAPTER IV EU guarantee Article 13 EU guarantee 1. The EU guarantee shall be granted as an irrevocable, unconditional and on demand guarantee to the implementing partners in accordance with Article 219(1) of the Financial Regulation and implemented in indirect management in accordance with Title X of that Regulation. 2. The remuneration for the EU guarantee shall be linked to the characteristics and risk profile of the financial products, taking into account the nature of the underlying financing and investment operations and the fulfilment of the policy objectives targeted by the financial products. Where duly justified by the nature of the policy objectives targeted by the financial product and the need for the financial products to be affordable to the targeted final recipients, the cost of the financing provided to the final recipient may be reduced or the terms of that financing may be improved, by reducing the remuneration for the EU guarantee, or, where necessary, by covering the outstanding administrative costs borne by the implementing partner through the Union budget, in particular: (a) where stressed financial market conditions would prevent the realisation of a financing or investment operation under market-based pricing; or (b) where necessary to catalyse financing and investment operations in sectors or areas experiencing a significant market failure or suboptimal investment situation or to facilitate the establishment of investment platforms. The reduction of the remuneration for the EU guarantee or the coverage of the outstanding administrative costs borne by the implementing partner, referred to in the second subparagraph, may only be done to the extent that it does not significantly impact the provisioning for the EU guarantee. The reduction of the remuneration for the EU guarantee shall fully benefit final recipients. 3. The condition set out in Article 219(4) of the Financial Regulation shall apply to each implementing partner on a portfolio basis. 4. 75 % of the EU guarantee under the EU compartment as referred to in the first subparagraph of Article 4(1), amounting to EUR 19 614 232 554, shall be granted to the EIB Group. The EIB Group shall provide an aggregate financial contribution amounting to EUR 4 903 558 139. That contribution shall be provided in a manner and form that facilitates the implementation of the InvestEU Fund and the achievement of the objectives set out in Article 15(2). 5. The remaining 25 % of the EU guarantee under the EU compartment shall be granted to other implementing partners, which shall also provide a financial contribution to be determined in the guarantee agreements. 6. Best efforts shall be made to ensure that, at the end of the investment period, a wide range of sectors and regions are covered and excessive sectoral or geographical concentration is avoided. Those efforts shall include incentives for smaller or less sophisticated national promotional banks and institutions that have a comparative advantage due to their local presence, knowledge and investment competencies. The Commission shall develop a coherent approach to support those efforts. 7. Support under the EU guarantee referred to in the first subparagraph of Article 4(2) of this Regulation shall be granted under the conditions set out in Article 3(6) of Regulation (EU) 2020/2094. In other cases, support under the EU guarantee may be granted for financing and investment operations covered by this Regulation for an investment period ending on 31 December 2027. Contracts between the implementing partner and the final recipient or the financial intermediary or other entity referred to in point (a) of Article 16(1) under the EU guarantee referred to in the first subparagraph of Article 4(2) shall be signed at the latest one year after the approval of the relevant financing or investment operation by the implementing partner. In other cases, contracts between the implementing partner and the final recipient or the financial intermediary or other entity referred to in point (a) of Article 16(1) shall be signed by 31 December 2028. Article 14 Eligible financing and investment operations 1. The InvestEU Fund shall only support financing and investment operations that: (a) comply with the conditions set out in points (a) to (e) of Article 209(2) of the Financial Regulation, in particular regarding market failures, suboptimal investment situations and additionality as set out in points (a) and (b) of Article 209(2) of the Financial Regulation and in Annex V to this Regulation and, where appropriate, maximising private investment in accordance with point (d) of Article 209(2) of the Financial Regulation; (b) contribute to the Union policy objectives and fall within the scope of the areas eligible for financing and investment operations under the appropriate policy window in accordance with Annex II to this Regulation; (c) do not provide financial support to the excluded activities set out in Section B of Annex V to this Regulation; and (d) are consistent with the investment guidelines. 2. In addition to projects situated in the Union, or in an overseas country or territory linked to a Member State as set out in Annex II to the TFEU, the InvestEU Fund may support the following projects and operations through financing and investment operations: (a) projects involving entities located or established in one or more Member States that extend to one or more third countries, including acceding countries, candidate countries and potential candidates, countries falling within the scope of the European Neighbourhood Policy, the EEA or the EFTA, to an overseas country or territory as set out in Annex II to the TFEU, or to an associated third country, regardless of whether there is a partner in those third countries or overseas countries or territories; (b) financing and investment operations in third countries as referred to in Article 5 which have contributed to a specific financial product. 3. The InvestEU Fund may support financing and investment operations that provide finance to final recipients which are legal entities established in any of the following countries or territories: (a) a Member State or an overseas country or territory linked to a Member State as set out in Annex II to the TFEU; (b) a third country associated to the InvestEU Programme in accordance with Article 5; (c) a third country referred to in point (a) of paragraph 2, where applicable; (d) other third countries, where necessary for the financing of a project in a country or territory referred to in points (a), (b) or (c). Article 15 Selection of implementing partners other than the EIB Group 1. The Commission shall select implementing partners other than the EIB Group in accordance with Article 154 of the Financial Regulation. Implementing partners may form a group. An implementing partner may be a member of one or more groups. For the EU compartment, the eligible counterparties shall have expressed their interest in relation to the portion of the EU guarantee referred to in Article 13(5). For the Member State compartment, the Member State concerned may propose one or more counterparties as implementing partners from among those counterparties that have expressed their interest. The Member State concerned may also propose the EIB Group as an implementing partner and, at its own expense, may contract the EIB Group to provide the services listed in Article 11. Where the Member State concerned does not propose an implementing partner, the Commission shall proceed in accordance with the third subparagraph of this paragraph and shall select as implementing partners eligible counterparties that are able to cover the financing and investment operations in the geographical areas concerned. 2. When selecting implementing partners, the Commission shall ensure that the portfolio of financial products under the InvestEU Fund meets the following objectives: (a) maximising the coverage of the objectives laid down in Article 3; (b) maximising the impact of the EU guarantee through the own resources committed by the implementing partner; (c) maximising, where appropriate, private investment; (d) promoting innovative financial and risk solutions to address market failures and suboptimal investment situations; (e) achieving geographical diversification via gradual allocation of the EU guarantee, and to allow for the financing of smaller projects; (f) providing sufficient risk diversification. 3. When selecting the implementing partners, the Commission shall also take into account: (a) the possible cost and remuneration to the Union budget; (b) the capacity of the implementing partner to implement thoroughly the requirements of Article 155(2) and (3) of the Financial Regulation related to tax avoidance, tax fraud, tax evasion, money laundering, terrorism financing and non-cooperative jurisdictions. 4. National promotional banks and institutions may be selected as implementing partners, provided that they fulfil the requirements laid down in this Article. Article 16 Eligible types of financing 1. The EU guarantee may be used towards risk coverage for the following types of financing provided by the implementing partners: (a) loans, guarantees, counter-guarantees, capital market instruments, any other form of funding or credit enhancement, including subordinated debt, or equity or quasi-equity investments, provided directly or indirectly through financial intermediaries, funds, investment platforms or other vehicles to be channelled to final recipients; (b) funding or guarantees by an implementing partner to another financial institution enabling the latter to undertake financing referred to in point (a). In order to be covered by the EU guarantee, the financing referred to in points (a) and (b) of the first subparagraph of this paragraph shall be granted, acquired or issued for the benefit of financing and investment operations referred to in Article 14(1), where the financing by the implementing partner was granted in accordance with a financing agreement or transaction signed or entered into by the implementing partner after the signature of the guarantee agreement and that has not expired or been cancelled. 2. Financing and investment operations through funds or other intermediate structures shall be supported by the EU guarantee in accordance with provisions to be laid down in the investment guidelines, even if such structures invest a minority of their invested amounts outside the Union and in third countries referred to Article 14(2) or invest a minority of their invested amounts into assets other than those eligible under this Regulation. Article 17 Guarantee agreements 1. The Commission shall conclude a guarantee agreement with each implementing partner on the granting of the EU guarantee up to an amount to be determined by the Commission. In the event that implementing partners form a group, a single guarantee agreement shall be concluded between the Commission and each implementing partner within the group or with one implementing partner on behalf of the group. 2. The guarantee agreement shall contain: (a) the amount and the terms of the financial contribution which is to be provided by the implementing partner; (b) the terms of the funding or the guarantees which are to be provided by the implementing partner to another legal entity participating in the implementation, whenever that is the case; (c) detailed rules on the provision of the EU guarantee in accordance with Article 19, including on the coverage of portfolios of specific types of instruments and the respective events that trigger possible calls on the EU guarantee; (d) the remuneration for risk-taking that is to be allocated in proportion to the respective share of the risk-taking of the Union and of the implementing partner or as reduced in duly justified cases pursuant to Article 13(2); (e) the payment conditions; (f) the commitment of the implementing partner to accept the decisions by the Commission and the Investment Committee as regards the use of the EU guarantee for the benefit of a proposed financing or investment operation, without prejudice to the decision-making of the implementing partner in respect of the proposed financing or investment operation without the EU guarantee; (g) provisions and procedures relating to the recovery of claims that is to be entrusted to the implementing partner; (h) financial and operational reporting and monitoring of the financing and investment operations under the EU guarantee; (i) key performance indicators, in particular as regards the use of the EU guarantee, the fulfilment of the objectives and criteria laid down in Articles 3, 8 and 14, and the mobilisation of private capital; (j) where applicable, provisions and procedures relating to blending operations; (k) other relevant provisions in compliance with the requirements of Article 155(2) and Title X of the Financial Regulation; (l) the existence of adequate mechanisms for addressing the potential concerns of private investors. 3. A guarantee agreement shall also provide that remuneration attributable to the Union from financing and investment operations covered by this Regulation is to be provided after the deduction of payments due upon calls on the EU guarantee. 4. In addition, a guarantee agreement shall provide that any amount due to the implementing partner that relates to the EU guarantee shall be deducted from the overall amount of remuneration, revenues and repayments due by the implementing partner to the Union from financing and investment operations covered by this Regulation. Where that amount is not sufficient to cover the amount due to the implementing partner in accordance with Article 18(3), the outstanding amount shall be drawn from the provisioning for the EU guarantee. 5. Where the guarantee agreement is concluded under the Member State compartment, it may provide for the participation of representatives from the Member State or the regions concerned in the monitoring of the implementation of that guarantee agreement. Article 18 Requirements for the use of the EU guarantee 1. The granting of the EU guarantee shall be subject to the entry into force of the guarantee agreement with the relevant implementing partner. 2. Financing and investment operations shall be covered by the EU guarantee only where they fulfil the criteria laid down in this Regulation and in the relevant investment guidelines, and where the Investment Committee has concluded that those operations fulfil the requirements for benefiting from the EU guarantee. The implementing partners shall remain responsible for ensuring that the financing and investment operations comply with this Regulation and the relevant investment guidelines. 3. No administrative costs or fees related to the implementation of financing and investment operations under the EU guarantee shall be due to the implementing partner by the Commission unless the nature of the policy objectives targeted by the financial product to be implemented and the affordability for the targeted final recipients or the type of financing provided allow the implementing partner to duly justify to the Commission the need for an exception. The coverage of such costs by the Union budget shall be limited to the amount strictly required to implement the relevant financing and investment operations, and shall be provided only to the extent to which the costs are not covered by revenues received by the implementing partners from the financing and investment operations concerned. The fee arrangements shall be laid down in the guarantee agreement and shall comply with Article 17(4) of this Regulation and with point (g) of Article 209(2) of the Financial Regulation. 4. In addition, the implementing partner may use the EU guarantee to meet the relevant share of any recovery costs in accordance with Article 17(4), unless those costs have been deducted from recovery proceeds. Article 19 Coverage and terms of the EU guarantee 1. Remuneration for risk-taking shall be allocated between the Union and an implementing partner in proportion to their respective share of the risk-taking with respect to a portfolio of financing and investment operations or, where relevant, with respect to individual financing and investment operations. The remuneration for the EU guarantee may be reduced in duly justified cases referred to in Article 13(2). The implementing partner shall have appropriate exposure at its own risk to financing and investment operations supported by the EU guarantee, unless exceptionally the policy objectives targeted by the financial product to be implemented are of such nature that the implementing partner could not reasonably contribute its own risk-bearing capacity to it. 2. The EU guarantee shall cover: (a) for debt products referred to in point (a) of Article 16(1): (i) the principal and all interest and amounts due to the implementing partner but not received by it in accordance with the terms of the financing operations prior to the event of default; (ii) restructuring losses; (iii) losses arising from fluctuations of currencies other than the euro in markets where possibilities for long-term hedging are limited; (b) for equity or quasi-equity investments referred to in point (a) of Article 16(1): the amounts invested and the associated funding costs and losses arising from fluctuations of currencies other than the euro; (c) for funding or guarantees by an implementing partner to another financial institution in accordance with point (b) of Article 16(1): the amounts used and their associated funding costs. For the purposes of point (a)(i) of the first subparagraph, for subordinated debt a deferral, reduction or required exit shall be considered to be an event of default. 3. Where the Union makes a payment to the implementing partner as the result of a call on the EU guarantee, the Union shall be subrogated into the relevant rights of the implementing partner relating to any of its financing or investment operations covered by the EU guarantee, to the extent that those rights continue to exist. The implementing partner shall pursue the recovery of claims for the subrogated amounts on behalf of the Union and shall reimburse the Union from the amounts recovered. CHAPTER V Governance Article 20 Advisory Board 1. The Commission and the Steering Board established pursuant to Article 21 shall be advised by an advisory board (the \u2018Advisory Board\u2019). 2. The Advisory Board shall strive to ensure gender balance and shall comprise: (a) one representative of each implementing partner; (b) one representative of each Member State; (c) one expert appointed by the European Economic and Social Committee; (d) one expert appointed by the Committee of the Regions. 3. The Advisory Board shall be chaired by a representative of the Commission. The representative of the EIB Group shall be the vice-chair. The Advisory Board shall meet regularly, at least twice a year, at the request of the Chairperson. 4. The Advisory Board shall: (a) provide advice to the Commission and the Steering Board on the design of financial products to be deployed under this Regulation; (b) provide advice to the Commission and the Steering Board about market developments, market conditions, market failures and suboptimal investment situations; (c) exchange views on market developments and share best practices. 5. The Commission shall nominate the first Advisory Board members representing the implementing partners other than the EIB Group after consultation of potential implementing partners. Their term is limited to one year. 6. Meetings of representatives of the Member States in a separate format shall also be organised at least twice a year and chaired by the Commission. 7. The Advisory Board and the meetings of the representatives of the Member States referred to in paragraph 6 may issue recommendations to the Steering Board for its consideration regarding the implementation and operation of the InvestEU Programme. 8. Detailed minutes of the meetings of the Advisory Board shall be made public as soon as possible after they have been approved by the Advisory Board. The Commission shall establish the operating rules and procedures for the Advisory Board and shall manage the secretariat of the Advisory Board. All relevant documentation and information shall be made available to the Advisory Board to enable it to exercise its tasks. 9. The national promotional banks and institutions represented on the Advisory Board shall select from among themselves the representatives of the implementing partners other than the EIB Group in the Steering Board established pursuant to Article 21. The national promotional banks and institutions shall aim to achieve a balanced representation in the Steering Board in terms of size and geographical location. The representatives selected shall represent the agreed common position of all implementing partners other than the EIB Group. Article 21 Steering Board 1. A steering board for the InvestEU Programme (the \u2018Steering Board\u2019) shall be established. It shall be composed of four representatives of the Commission, three representatives of the EIB Group and two representatives of the implementing partners other than the EIB Group and one expert appointed as a non-voting member by the European Parliament. The expert appointed as a non-voting member by the European Parliament shall not seek or take instructions from Union institutions, bodies, offices or agencies, from any Member State government or from any other public or private body and shall act with full independence. That expert shall perform his or her duties impartially and in the interest of the InvestEU Programme. Members of the Steering Board shall be appointed for a term of four years, renewable once, with the exception of the representatives of the implementing partners other than the EIB Group, who shall be appointed for a term of two years. 2. The Steering Board shall select a Chairperson from among the Commission representatives for a term of four years, renewable once. The Chairperson shall report biannually to the representatives of the Member States on the Advisory Board on the implementation and operation of the InvestEU Programme. Detailed minutes of Steering Board meetings shall be published as soon as they have been approved by the Steering Board. 3. The Steering Board shall: (a) provide strategic and operational guidance for the implementing partners, including guidance on the design of financial products and on other operating policies and procedures necessary for the operation of the InvestEU Fund; (b) adopt the risk methodological framework developed by the Commission in cooperation with the EIB Group and the other implementing partners; (c) oversee the implementation of the InvestEU Programme; (d) be consulted, reflecting the views of all its member, on the shortlist of candidates for the Investment Committee before their selection in accordance with Article 24(2); (e) adopt the rules of procedure of the secretariat to the Investment Committee referred to in Article 24(4). (f) adopt the rules applicable to the operations with investment platforms. 4. The Steering Board shall use a consensual approach in its discussions, therefore taking the utmost possible account of the positions of all members. If the members cannot converge in their positions, decisions of the Steering Board are taken by qualified majority of its voting members, consisting of at least seven votes. Article 22 Scoreboard 1. A scoreboard of indicators (the \u2018Scoreboard\u2019) shall be established to ensure that the Investment Committee is able to carry out an independent, transparent and harmonised assessment of requests for the use of the EU guarantee for financing and investment operations proposed by implementing partners. 2. Implementing partners shall fill out the Scoreboard for their proposals for financing and investment operations. 3. The Scoreboard shall cover the following elements: (a) a description of the proposed financing or investment operation; (b) how the proposed financing or investment operation contributes to EU policy objectives; (c) a description of additionality; (d) a description of the market failure or suboptimal investment situation; (e) the financial and technical contribution by the implementing partner; (f) the impact of the investment; (g) the financial profile of the financing or investment operation; (h) complementary indicators. 4. The Commission is empowered to adopt delegated acts in accordance with Article 34 in order to supplement this Regulation by establishing additional elements of the Scoreboard, including detailed rules for the Scoreboard to be used by the implementing partners. Article 23 Policy check 1. The Commission shall conduct a check to confirm that the financing and investment operations proposed by the implementing partners other than the EIB comply with Union law and policies. 2. EIB financing and investment operations that fall within the scope of this Regulation shall not be covered by the EU guarantee where the Commission delivers an unfavourable opinion within the framework of the procedure provided for in Article 19 of the EIB Statute. Article 24 Investment Committee 1. A fully independent investment committee shall be established for the InvestEU Fund (the \u2018Investment Committee\u2019). The Investment Committee shall: (a) examine the proposals for financing and investment operations submitted by implementing partners for coverage under the EU guarantee that have passed the policy check referred to in Article 23(1) of this Regulation or that have received a favourable opinion within the framework of the procedure provided for in Article 19 of the EIB Statute; (b) verify the compliance of the proposals referred to in point (a) with this Regulation and the relevant investment guidelines; and (c) check whether the financing and investment operations that would benefit from the support under the EU guarantee comply with all relevant requirements. When performing the tasks referred to in the first subparagraph of this paragraph, the Investment Committee shall give particular attention to the additionality requirements set out in point (b) of Article 209(2) of the Financial Regulation and in Annex V to this Regulation and to the requirement to crowd in private investment set out in point (d) of Article 209(2) of the Financial Regulation. 2. The Investment Committee shall meet in four different configurations, corresponding to the four policy windows referred to in Article 8(1). Each configuration of the Investment Committee shall be composed of six remunerated external experts. The experts shall be selected and shall be appointed by the Commission, at the recommendation of the Steering Board. The experts shall be appointed for a term of up to four years, renewable once. They shall be remunerated by the Union. The Commission, at the recommendation of the Steering Board, may decide to renew the term of office of an incumbent member of the Investment Committee without following the procedure laid down in this paragraph. The experts shall have a high level of relevant market experience in project structuring and financing or financing of SMEs or corporates. The composition of the Investment Committee shall ensure that it has a wide knowledge of the sectors covered by the policy windows referred to in Article 8(1) and a wide knowledge of the geographic markets in the Union, and shall ensure that the Investment Committee as a whole is gender-balanced. Four members of the Investment Committee shall be permanent members of each of the four configurations of the Investment Committee. At least one of the permanent members shall have expertise in sustainable investment. In addition, each of the four configurations shall have two experts with experience in investment in sectors covered by the corresponding policy window. The Steering Board shall assign the Investment Committee members to the appropriate configuration or configurations. The Investment Committee shall elect a chairperson from among its permanent members. 3. When participating in the activities of the Investment Committee, its members shall perform their duties impartially and in the sole interest of the InvestEU Fund. They shall not seek or take instructions from the implementing partners, the institutions of the Union, the Member States, or any other public or private body. The curricula vitae and declarations of interest of each member of the Investment Committee shall be made public and kept up to date. Each member of the Investment Committee shall without delay communicate to the Commission and the Steering Board all information needed to confirm the absence of any conflict of interest on an ongoing basis. The Steering Board may recommend to the Commission that it remove a member from his or her functions if that member does not comply with the requirements laid down in this paragraph or for other duly justified reasons. 4. When acting in accordance with this Article, the Investment Committee shall be assisted by a secretariat. The secretariat shall be independent and answerable to the chairperson of the Investment Committee. The secretariat shall be administratively located in the Commission. The rules of procedure of the secretariat shall ensure the confidentiality of exchanges of information and documents between implementing partners and the respective governing bodies. The EIB Group may submit its proposals for financing and investment operations directly to the Investment Committee and shall notify them to the secretariat. The documentation to be provided by the implementing partners shall comprise a standardised request form, the Scoreboard referred to in Article 22 and any other document the Investment Committee considers relevant, in particular a description of the character of the market failure or suboptimal investment situation and how it will be alleviated by the financing or investment operation, as well as a reliable assessment of the operation that demonstrates the additionality of the financing or investment operation. The secretariat shall check the completeness of the documentation provided by implementing partners other than the EIB Group. The Investment Committee may seek clarifications from the implementing partner concerned in relation to a proposal for an investment or financing operation, including by requesting the direct presence of a representative of the implementing partner concerned during the discussion of the aforementioned operation. Any project assessment conducted by an implementing partner shall not be binding on the Investment Committee for the purposes of granting a financing or investment operation coverage by the EU guarantee. The Investment Committee shall use the Scoreboard referred to in Article 22 in its assessment and verification of the proposed financial and investment operations. 5. Conclusions of the Investment Committee shall be adopted by simple majority of all members, provided that such simple majority includes at least one of the non-permanent members of the configuration relating to the policy window under which the proposal is made. In the event of a draw, the chair of the Investment Committee shall have the casting vote. Conclusions of the Investment Committee approving the coverage of the EU guarantee for a financing or investment operation shall be publicly accessible and shall include the rationale for the approval and information on the operation, in particular its description, the identity of the promoters or financial intermediaries, and the objectives of the operation. The conclusions shall also refer to the global assessment stemming from the Scoreboard. The relevant Scoreboard shall be made publicly accessible after the signature of the financing or investment operation or sub-project, if applicable. Information to be made publicly accessible under the second and third subparagraphs shall not contain commercially sensitive information or personal data that are not to be disclosed under the Union data protection rules. Commercially sensitive parts of the conclusions of the Investment Committee shall be forwarded by the Commission to the European Parliament and to the Council upon request subject to strict confidentiality requirements. Twice a year, the Investment Committee shall submit to the European Parliament and to the Council a list of all conclusions of the Investment Committee in the preceding six months, as well as the published Scoreboards relating thereto. That submission shall include any decisions rejecting the use of the EU guarantee. Those decisions shall be subject to strict confidentiality requirements. Conclusions of the Investment Committee shall be made available in a timely manner to the implementing partner concerned by the secretariat of the Investment Committee. The secretariat of the Investment Committee shall record all information related to proposals for financing and investment operations provided to the Investment Committee and the conclusions of the Investment Committee on those proposals in a central repository. 6. Where the Investment Committee is requested to approve the use of the EU guarantee for a financing or investment operation that is a facility, programme or structure which has underlying sub-projects, that approval shall comprise those underlying sub-projects unless the Investment Committee decides to retain the right to approve them separately. The Investment Committee shall not have the right to separately approve sub-projects of a size below EUR 3 000 000. 7. Where it deems it necessary, the Investment Committee may bring to the Commission any operational issue relating to the application or interpretation of the investment guidelines. CHAPTER VI InvestEU Advisory Hub Article 25 InvestEU Advisory Hub 1. The Commission shall establish the InvestEU Advisory Hub. The InvestEU Advisory Hub shall provide advisory support for the identification, preparation, development, structuring, procuring and implementation of investment projects, and for enhancing the capacity of project promoters and financial intermediaries to implement financing and investment operations. Such support may cover any stage of the life cycle of a project or financing of a supported entity. The Commission shall conclude advisory agreements with the EIB Group and other potential advisory partners and task them with the provision of advisory support as referred to in the first subparagraph of this paragraph and of the services referred to in paragraph 2. The Commission may also implement advisory initiatives, including through contracting external service providers. The Commission shall establish a central entry point to the InvestEU Advisory Hub and shall allocate requests for advisory support to be dealt under the appropriate advisory initiative. The Commission, the EIB Group and the other advisory partners shall cooperate closely with a view to ensuring efficiency, synergies and effective geographic coverage of support across the Union, while taking due account of existing structures and work. Advisory initiatives shall be available as a component under each policy window referred to in Article 8(1), covering sectors under that window. In addition, advisory initiatives shall be available under a cross-sectoral component. 2. The InvestEU Advisory Hub shall in particular: (a) provide a central point of entry, managed and hosted by the Commission, for project development assistance under the InvestEU Advisory Hub for public authorities and for project promoters; (b) disseminate to public authorities and project promoters all available additional information regarding the investment guidelines, including information on their application or on the interpretation provided by the Commission; (c) where appropriate, assist project promoters in developing their projects so that they fulfil the objectives set out in Articles 3 and 8 and the eligibility criteria set out in Article 14, and facilitate the development of among others important projects of common European interest and aggregators for small-sized projects, including through investment platforms as referred to in point (f) of this paragraph, provided that such assistance does not prejudge the conclusions of the Investment Committee with respect to the coverage of the EU guarantee with respect to such projects; (d) support actions and leverage local knowledge to facilitate the use of InvestEU Fund support across the Union and contribute actively where possible to the objective of the sectorial and geographical diversification of the InvestEU Fund by supporting implementing partners in originating and developing potential financing and investment operations; (e) facilitate the establishment of collaborative platforms for peer-to-peer exchanges and the sharing of data, knowhow and best practices to support project pipeline and sector development; (f) provide proactive advisory support with respect to the establishment of investment platforms, including cross-border and macro-regional investment platforms and investment platforms that bundle small and medium-sized projects in one or more Member States by theme or by region; (g) support the use of blending with grants or financial instruments funded by the Union budget or by other sources in order to strengthen synergies and complementarities between Union instruments and to maximise the leverage and impact of the InvestEU Programme; (h) support capacity building actions to develop organisational capacities, skills and processes and to accelerate the investment readiness of organisations in order for public authorities and project promoters to build investment project pipelines, develop financing mechanisms and investment platforms and to manage projects and for financial intermediaries to implement financing and investment operations for the benefit of entities that face difficulties in obtaining access to finance, including through support for developing risk assessment capacity or sector specific knowledge; (i) providing advisory support for start-ups, especially when they seek to protect their research and innovation investments by obtaining intellectual property titles, such as patents. 3. The InvestEU Advisory Hub shall be available to public and private project promoters, including SMEs and start-ups, to public authorities, to national promotional banks and institutions, and to financial and non-financial intermediaries. 4. The Commission shall conclude an advisory agreement with each advisory partner on the implementation of one or more advisory initiatives. The InvestEU Advisory Hub may charge fees for the services referred to in paragraph 2 to cover part of the costs for providing those services, except for services provided to public project promoters or non-profit institutions, which shall be free of charge where justified. Fees charged to SMEs for those services referred to in paragraph 2 shall be capped at one third of the cost of providing those services. 5. In order to carry out the activities referred to in paragraph 1 and to facilitate the provision of advisory support, the InvestEU Advisory Hub shall build upon the expertise of the Commission, the EIB Group and the other advisory partners. 6. Each advisory initiative shall incorporate a cost-sharing mechanism between the Commission and the advisory partner, except where the Commission agrees to cover all costs of the advisory initiative in a duly justified case where the specificities of the advisory initiative so require and the coherent and equitable treatment of advisory partners concerned is ensured. 7. The InvestEU Advisory Hub shall have local presence where necessary. Local presence shall be established in particular in Member States or regions that face difficulties in developing projects under the InvestEU Fund. The InvestEU Advisory Hub shall assist in the transfer of knowledge to the regional and local level with a view to building up regional and local capacity and expertise to be able to provide advisory support referred to in paragraph 1, including support to implement and accommodate small-sized projects. 8. In order to provide the advisory support referred in paragraph 1 and to facilitate the provision of that advisory support at local level, the InvestEU Advisory Hub shall cooperate where possible with and take advantage of the expertise of national promotional banks and institutions. Where appropriate, cooperation agreements with national promotional banks and institutions shall be concluded under the InvestEU Advisory Hub, with at least one national promotional bank or institution per Member State. 9. The implementing partners shall, as appropriate, propose to project promoters applying for financing, including in particular small-sized projects, that they request the InvestEU Advisory Hub support for their projects, where appropriate, in order to enhance the preparation of their projects and to allow for the assessment of the possibility of bundling projects. Where relevant, the implementing partners and advisory partners shall also inform the project promoters of the possibility of listing their projects on the InvestEU Portal referred to in Article 26. CHAPTER VII InvestEU Portal Article 26 InvestEU Portal 1. The Commission shall establish the InvestEU Portal. The InvestEU Portal shall be an easily accessible and user-friendly project database that provides relevant information for each project. 2. The InvestEU Portal shall provide a channel for project promoters to make projects for which they are seeking finance visible to investors. The inclusion of projects in the InvestEU Portal shall be without prejudice to decisions on the final projects selected for support under this Regulation or under any other Union instrument, or to decisions for public funding. Only projects that are compatible with Union law and policies shall be listed on the InvestEU Portal. 3. The Commission shall transmit projects that are compatible with Union law and policies to the relevant implementing partners. Where appropriate and where an advisory initiative exists, the Commission shall also transmit such projects to the InvestEU Advisory Hub. 4. Implementing partners shall examine projects falling within their geographic and activity scope. CHAPTER VIII Accountability, monitoring and reporting, evaluation and control Article 27 Accountability 1. At the request of the European Parliament or of the Council, the Chairperson of the Steering Board shall report on the performance of the InvestEU Fund to the requesting institution, including by participating in a hearing before the European Parliament. 2. The Chairperson of the Steering Board shall reply orally or in writing to questions addressed to the InvestEU Fund by the European Parliament or by the Council within five weeks of their receipt. Article 28 Monitoring and reporting 1. Indicators to report on the progress of the InvestEU Programme towards the achievement of the general and specific objectives laid down in Article 3 are set out in Annex III. 2. The performance reporting system shall ensure that data for monitoring the implementation and the results of the InvestEU Programme are collected efficiently, effectively and in a timely manner, and that those data allow for adequate risk and guarantee portfolio monitoring. To that end, proportionate reporting requirements shall be imposed on the implementing partners, the advisory partners and other recipients of Union funds, as appropriate. 3. The Commission shall report on the implementation of the InvestEU Programme in accordance with Articles 241 and 250 of the Financial Regulation. In accordance with Article 41(5) of the Financial Regulation, the annual report shall provide information on the level of implementation of the Programme with respect to its objectives and performance indicators. For that purpose, each implementing partner shall provide on an annual basis the information necessary to allow the Commission to comply with its reporting obligations, including information on the operation of the EU guarantee. 4. Every six months, each implementing partner shall submit a report to the Commission on the financing and investment operations covered by this Regulation, broken down by EU compartment and Member State compartment, as appropriate. Each implementing partner shall also submit information on the Member State compartment to the Member State whose compartment it implements. The report shall include an assessment of compliance with the requirements on the use of the EU guarantee and with the key performance indicators laid down in Annex III to this Regulation. The report shall also include operational, statistical, financial and accounting data on each financing or investment operation and an estimation of expected cash flows, at the level of compartment, policy window and the InvestEU Fund. Once a year, the report from the EIB Group and, where appropriate, from other implementing partners, shall also include information on barriers to investment encountered when carrying out financing and investment operations covered by this Regulation. The reports shall contain the information the implementing partners have to provide under point (a) of Article 155(1) of the Financial Regulation. 5. To ensure the effective assessment of the progress of the InvestEU Programme towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 34, to amend Annex III with regard to the indicators where considered necessary as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. Article 29 Evaluation 1. Evaluations of the InvestEU Programme shall be carried out so that they feed into the decision-making process in a timely manner. 2. By 30 September 2024, the Commission shall submit to the European Parliament and to the Council an independent interim evaluation report on the InvestEU Programme, in particular on the use of the EU guarantee, on the fulfilment of the EIB Group\u2019s obligations under points (b) and (c) of the first subparagraph of Article 11(1), on the allocation of the EU guarantee provided for in Article 13(4) and (5), on the implementation of the InvestEU Advisory Hub, on the budgetary allocation provided for in point (d)(i) of the first subparagraph of Article 11(1), and on Article 8(8). The evaluation shall in particular demonstrate how the inclusion of the implementing partners and advisory partners in the implementation of the InvestEU Programme has contributed to the reaching of InvestEU Programme targets as well as EU policy goals, especially with regard to added value and the geographical and sectoral balance of the supported financing and investment operations. The evaluation shall also assess the application of sustainability proofing pursuant to Article 8(5) and the focus on SMEs reached under the SME policy window referred to in point (c) of Article 8(1). 3. At the end of the implementation of the InvestEU Programme, but no later than 31 December 2031, the Commission shall submit to the European Parliament and to the Council an independent final evaluation report on the InvestEU Programme, in particular on the use of the EU guarantee. 4. The Commission shall communicate the conclusions of the evaluations, accompanied by its observations, to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions. 5. The implementing partners and advisory partners shall contribute to and provide the Commission with the information necessary to perform the evaluations referred to in paragraphs 2 and 3. 6. In accordance with Article 211(1) of the Financial Regulation, every three years the Commission shall include in the annual report referred to in Article 250 of the Financial Regulation a review of the adequacy of the provisioning rate laid down in Article 4(1) of this Regulation with respect to the actual risk profile of the financing and investment operations covered by the EU guarantee. The Commission is empowered to adopt delegated acts in accordance with Article 34 of this Regulation in order to amend this Regulation by adjusting the provisioning rate laid down in Article 4(1) of this Regulation by up to 15 % on the basis of that review. Article 30 Audits Audits of the use of the Union funding carried out by persons or entities, including by persons or entities other than those mandated by Union institutions or bodies, shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. Article 31 Protection of the financial interests of the Union Where a third country participates in the InvestEU Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. CHAPTER IX Transparency and visibility Article 32 Information, communication and publicity 1. Implementing partners and advisory partners shall acknowledge the origin and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. The application of the requirements under the first subparagraph to projects in defence and space sectors and in cybersecurity shall be subject to respect for any confidentiality or secrecy obligations. 2. The implementing partners and advisory partners shall inform the final recipients, including SMEs, of the existence of support under the InvestEU Programme, or oblige other financial intermediaries to inform such final recipients of that support, by making that information clearly visible in the relevant agreement providing support under the InvestEU Programme, particularly in the case of SMEs, in order to increase public awareness and improve visibility. 3. The Commission shall implement information and communication actions relating to the InvestEU Programme, to actions taken pursuant to the InvestEU Programme and to the results obtained. Financial resources allocated to the InvestEU Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. CHAPTER X Participation of the European Union in the capital increase of the European Investment Fund Article 33 Participation in a capital increase of the EIF In addition to its shareholding in the EIF at 3 December 2020, the Union shall subscribe for up to 853 shares in the EIF, each of a nominal value of EUR 1 000 000, so that its relative share in the capital remains at a level equivalent to that on 3 December 2020. The subscription of the shares and the payment of up to EUR 375 000 000 for the paid-in part of the shares and for the share premium shall be carried out in accordance with terms and conditions that shall be approved by the General Meeting of the EIF and before 31 December 2021. The resulting subscribed but not paid-in part of the shares acquired under this Article shall not exceed EUR 682 400 000. CHAPTER XI Transitional and final provisions Article 34 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. Where delegated acts concern activities to be carried out by or involving the EIB Group and other implementing partners, the Commission shall consult with the EIB Group and other potential implementing partners before preparing those delegated acts. 2. The power to adopt delegated acts referred to in Articles 8(9), 22(4), 28(5) and 29(6) shall be conferred on the Commission until 31 December 2028. The Commission shall draw up a report in respect of the delegation of power not later than nine months before that date. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 8(9), 22(4), 28(5) and 29(6) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 8(9), 22(4), 28(5) and 29(6) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 35 Transitional provisions 1. By way of derogation from the first and fourth subparagraphs of Article 209(3) of the Financial Regulation, any revenues, repayments and recoveries from financial instruments established by programmes referred to in Annex IV to this Regulation may be used for the provisioning of the EU guarantee under this Regulation, taking into account the relevant provisions concerning the budget laid down in the Public Sector Loan Facility Regulation for 2021-2027. 2. By way of derogation from point (a) of Article 213(4) of the Financial Regulation, any surplus of provisions for the EU guarantee established by Regulation (EU) 2015/1017 may be used for the provisioning of the EU guarantee under this Regulation, taking into account the relevant provisions concerning the budget laid down in the Public Sector Loan Facility Regulation for 2021-2027. 3. The amount of EUR 6 074 000 000 in current prices referred to in point (c) of Article 2(2) of Regulation (EU) 2020/2094 shall be used: (a) for the provisioning of the EU guarantee under this Regulation with an amount of EUR 5 930 000 000 in current prices, in addition to the resources mentioned in the first subparagraph of Article 211(4) of the Financial Regulation; (b) for the implementation of the measures provided in Chapters VI and VII of this Regulation and the measures referred to in the second sentence of Article 1(3) of Regulation (EU) 2020/2094, subject to Article 3(4) and (8) of that Regulation, with an amount of EUR 142 500 000 in current prices. That amount shall constitute an external assigned revenue in accordance with Article 21(5) of the Financial Regulation. 4. By way of derogation from the second subparagraph of Article 16(1) of this Regulation, financing and investment operations signed or entered into by an implementing partner during the period from 1 January 2021 until the signature of their respective guarantee agreements may be covered by the EU guarantee provided that those operations are indicated in the guarantee agreement, pass the policy check referred to in Article 23(1) of this Regulation or receive a favourable opinion within the framework of the procedure provided for in Article 19 of the EIB Statute and are in both cases approved by the Investment Committee in accordance with Article 24 of this Regulation. Article 36 Amendment of Regulation (EU) 2015/1017 The following article is inserted in Regulation (EU) 2015/1017: \u2018Article 11a Combination of EFSI portfolio with other portfolios By way of derogation from Article 11(6) of this Regulation and the second subparagraph of Article 10(2) of this Regulation, the EU guarantee may cover losses referred to in Article 11(6) of this Regulation in relation to the entire portfolio of financing and investment operations supported by the financial products referred to in Article 7(1) of Regulation (EU) 2021/523 of the European Parliament and of the Council (*1). Article 37 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 March 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 364, 28.10.2020, p. 139. (2) Position of the European Parliament of 9 March 2021 (not yet published in the Official Journal) and decision of the Council of 17 March 2021. (3) Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13). (4) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17). (5) OJ L 282, 19.10.2016, p. 4. (6) OJ L 309, 13.12.1993, p. 3. (7) Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1). (8) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). (9) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1). (10) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (11) OJ L 433I, 22.12.2020, p. 28. (12) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, p. 11). (13) Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (OJ L 209, 2.8.1997, p. 1). (14) Council Regulation (EC) No 1467/97 of 7 July 1997 on speeding up and clarifying the implementation of the excessive deficit procedure (OJ L 209, 2.8.1997, p. 6). (15) Regulation (EU) 2015/1017 of the European Parliament and of the Council of 25 June 2015 on the European Fund for Strategic Investments, the European Investment Advisory Hub and the European Investment Project Portal and amending Regulations (EU) No 1291/2013 and (EU) No 1316/2013 \u2014 the European Fund for Strategic Investments (OJ L 169, 1.7.2015, p. 1). (16) OJ C 170, 18.5.2020, p. 22. (17) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I , 22.12.2020, p. 23). (18) OJ L 123, 12.5.2016, p. 1. (19) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (20) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (21) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (22) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (23) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (24) OJ L 1, 3.1.1994, p. 3. (25) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (\u2018Overseas Association Decision\u2019) (OJ L 344, 19.12.2013, p. 1). (26) OJ L 29, 31.1.2020, p. 7. (27) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). ANNEX I AMOUNTS OF EU GUARANTEE PER SPECIFIC OBJECTIVE The indicative distribution referred to in the fourth subparagraph of Article 4(2) towards financial and investment operations shall be as follows: (a) up to EUR 9 887 682 891 for objectives referred to in point (a) of Article 3(2); (b) up to EUR 6 575 653 460 for objectives referred to in point (b) of Article 3(2); (c) up to EUR 6 906 732 440 for objectives referred to in point (c) of Article 3(2); (d) up to EUR 2 782 241 282 for objectives referred to in point (d) of Article 3(2). ANNEX II AREAS ELIGIBLE FOR FINANCING AND INVESTMENT OPERATIONS The financing and investment operations may include strategic investment to support final recipients whose activities are of strategic importance to the Union, in particular in view of the green and digital transitions, of enhanced resilience and of strengthening strategic value chains. They may include important projects of common European interest. The financing and investment operations may fall under one or more of the following areas: (1) the development of the energy sector in accordance with the Energy Union priorities, including security of energy supply, clean energy transition and the commitments taken under the 2030 Agenda for Sustainable Development and the Paris Agreement, in particular through: (a) the expansion of the generation, supply or use of clean and sustainable renewable and safe and sustainable other zero and low-emission energy sources and solutions; (b) energy efficiency and energy savings (with a focus on reducing demand through demand side management and the refurbishment of buildings); (c) the development, smartening and modernisation of sustainable energy infrastructure, in particular storage technologies, electricity interconnections between Member States and smart grids, both at the transmission and distribution level; (d) the development of innovative zero- and low-emission heat supply systems and the combined production of electricity and heat; (e) the production and supply of sustainable synthetic fuels from renewable/carbon-neutral sources and other safe and sustainable zero- and low-emission sources, biofuels, biomass and alternative fuels, including fuels for all modes of transport, in accordance with the objectives of Directive (EU) 2018/2001; (f) infrastructure for carbon capture, and storage in industrial processes, bioenergy plants and manufacturing facilities towards the energy transition; and (g) critical infrastructure, whether physical or virtual, including infrastructure elements identified as critical as well as land and real estate crucial for the use of such critical infrastructure and the provision of goods and services instrumental to the operation and maintenance of the critical infrastructure. (2) the development of sustainable and safe transport infrastructures and mobility solutions, equipment and innovative technologies in accordance with Union transport priorities and the commitments taken under the Paris Agreement, in particular through: (a) projects that support the development of the trans-European transport network (TEN-T) infrastructure, including infrastructure maintenance and safety, the urban nodes of TEN-T, maritime and inland ports, airports, multimodal terminals and the connection of such multimodal terminals to the TEN-T networks, and the telematic applications referred to in Regulation (EU) No 1315/2013 of the European Parliament and of the Council (1); (b) TEN-T infrastructure projects that make provision for the use of at least two different modes of transport, in particular multimodal freight terminals and passenger transport hubs; (c) smart and sustainable urban mobility projects that target low-emission urban transport modes, including inland waterway solutions and innovative mobility solutions, non-discriminatory accessibility, reduced air pollution and noise, energy consumption, networks of smart cities, maintenance, and increasing safety levels and decreasing the frequency of accidents, including for cyclists and pedestrians); (d) supporting the renewal and retrofitting of transport mobile assets with the view of deploying low and zero-emission mobility solutions, including through the use of alternative fuels in vehicles of all transport modes; (e) railway infrastructure, other rail projects, inland waterway infrastructure, mass transit projects and maritime ports and motorways of the sea; (f) alternative fuel infrastructure for all modes of transport, including electric charging infrastructure; (g) other smart and sustainable mobility projects that target: (i) road safety; (ii) accessibility; (iii) emission reduction; or (iv) the development and deployment of new transport technologies and services such as services that relate to connected and autonomous modes of transport or integrated ticketing; (h) projects to maintain or upgrade existing transport infrastructure, including motorways on the TEN-T where necessary to upgrade, maintain or improve road safety, to develop Intelligent Transport Systems (ITS) services or to guarantee infrastructure integrity and standards, to develop safe parking areas and facilities, recharging and refuelling stations for alternative fuels; and (i) critical infrastructure including infrastructure elements identified as critical as well as land and real estate crucial for the use of such critical infrastructure and the provision of goods and services instrumental to the operation and maintenance of the critical infrastructure. (3) environment and resources, in particular with respect to: (a) water, including drinking water supply and sanitation, and network efficiency, leakage reduction, infrastructure for the collection and treatment of waste water, coastal infrastructure and other water-related green infrastructure; (b) waste management infrastructure; (c) projects and enterprises in the fields of environmental resource management and sustainable technologies; (d) the enhancement and restoration of ecosystems and their services including through the enhancement of nature and biodiversity by means of green and blue infrastructure projects; (e) sustainable urban, rural and coastal development; (f) climate change actions, climate adaptation and mitigation, including natural hazard disaster risk reduction; (g) projects and enterprises that implement the circular economy by integrating resource efficiency aspects in the production and product life cycle, including the sustainable supply of primary and secondary raw materials; (h) the decarbonisation of energy-intensive industries and the substantial reduction of emissions in such industries, including the demonstration of innovative low-emission technologies and their deployment; (i) the decarbonisation of the energy production and distribution chain by phasing out the use of coal and oil; and (j) projects that promote sustainable cultural heritage. (4) the development of digital connectivity infrastructure, whether physical or virtual, in particular through projects that support the deployment of very high capacity digital networks or 5G connectivity or that improve digital connectivity and access, particularly in rural areas and peripheral regions. (5) research, development and innovation, in particular through: (a) research and innovation projects that contribute to the objectives of Horizon Europe, including research infrastructure and support to academia; (b) corporate projects, including training and promoting the creation of clusters and business networks; (c) demonstration projects and programmes, as well as deployment of related infrastructures, technologies and processes; (d) collaborative research and innovation projects involving academia, research and innovation organisations and industry; public-private partnerships and civil society organisations; (e) knowledge and technology transfer; (f) research in the field of key enabling technologies (KETs) and their industrial applications, including new and advanced materials; and (g) new effective and accessible healthcare products, including research, development, innovation and manufacturing of pharmaceuticals, medical devices, diagnostics and advanced therapy medicinal products and new antimicrobials, as well as innovative development processes that avoid using animal testing. (6) the development, deployment and scaling-up of digital technologies and services, especially digital technologies and services, including media, online service platforms and secure digital communication, that contribute to the objectives of the Digital Europe Programme, in particular through: (a) artificial intelligence; (b) quantum technology; (c) cybersecurity and network protection infrastructures; (d) the internet of things; (e) blockchain and other distributed ledger technologies; (f) advanced digital skills; (g) robotics and automatisation; (h) photonics; (i) other advanced digital technologies and services contributing to the digitisation of the Union industry and the integration of digital technologies, services and skills in the transport sector of the Union; and (j) recycling and manufacturing facilities for the production of information and communication technologies components and devices in the Union. (7) financial support to entities employing up to 499 employees, with a particular focus on SMEs, and small mid-cap companies, in particular through: (a) the provision of working capital and investment; (b) the provision of risk financing from seed to expansion stages to ensure their technological leadership in innovative and sustainable sectors including by enhancing their digitisation and innovation capacity, and their global competitiveness; (c) the provision of financing for the acquisition of a business by employees or participation in the ownership of a business by employees. (8) cultural and creative sectors, cultural heritage, media, the audio-visual sector, journalism and press, in particular through the development of new technologies, the use of digital technologies and technological management of intellectual property rights. (9) tourism. (10) the rehabilitation of industrial sites (including contaminated sites) and the restoration of such sites for sustainable use. (11) sustainable agriculture, forestry, fishery, aquaculture and other elements of the wider sustainable bioeconomy. (12) social investments, including those supporting the implementation of the European Pillar of Social Rights, in particular through: (a) microfinance, ethical, social enterprise finance and social economy; (b) demand for and the supply of skills; (c) education, training and related services, including for adults; (d) social infrastructure, in particular: (i) inclusive education and training, including early childhood education and care, and related educational infrastructure and facilities, alternative childcare, student housing and digital equipment, that are accessible for all; (ii) affordable social housing (2); (iii) health and long-term care, including clinics, hospitals, primary care, home services and community-based care; (e) social innovation, including innovative social solutions and schemes aimed at promoting social impacts and outcomes in the areas referred to in points (a) to (d) and (f) to (j); (f) cultural activities with a social objective; (g) measures to promote gender equality; (h) the integration of vulnerable people, including third country nationals; (i) innovative health solutions, including e-health, health services and new care models; (j) the inclusion of and accessibility for persons with disabilities. (13) the development of the defence industry in order to contribute to the Union\u2019s strategic autonomy, in particular through support for: (a) the Union\u2019s defence industry supply chain, in particular through financial support to SMEs and mid-caps; (b) companies participating in disruptive innovation projects in the defence sector and closely related dual-use technologies; (c) the defence sector supply chain when participating in collaborative defence research and development projects, including those supported by the European Defence Fund; (d) infrastructure for defence research and training. (14) space, in particular in relation to the development of the space sector in line with the objectives of the Space Strategy for Europe: (a) to maximise the benefits for the Union society and economy; (b) to foster the competitiveness of space systems and technologies, addressing in particular vulnerability of supply chains; (c) to underpin space entrepreneurship, including downstream development; (d) to foster Union\u2019s autonomy for safe and secure access to space, including dual use aspects. (15) seas and oceans, through the development of projects and enterprises in the area of the blue economy, and the Sustainable Blue Economy Finance Principles, in particular through maritime entrepreneurship and industry, renewable marine energy and circular economy. (1) Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, p. 1). (2) Affordable social housing is to be understood as aimed at disadvantaged persons or socially less advantaged groups, who due to solvency constraints live in severe housing deprivation or are unable to obtain housing at market conditions. ANNEX III KEY PERFORMANCE AND MONITORING INDICATORS 1. Volume of financing supported by the InvestEU Fund (broken down by policy window) 1.1 Volume of operations signed 1.2 Investment mobilised 1.3 Amount of private finance mobilised 1.4 Leverage and multiplier effect achieved 2. Geographical coverage of financing supported by the InvestEU Fund (broken down by policy window, country and region at the common classification of territorial units for statistics (NUTS) 2 level) 2.1 Number of countries (Member States and third countries) covered by operations 2.2 Number of regions covered by operations 2.3 Volume of operations per country (Member State and third country) and per region 3. Impact of financing supported by the InvestEU Fund 3.1 Number of jobs created or supported 3.2 Investment supporting climate objectives and, where applicable, broken down by policy window 3.3 Investment supporting digitisation 3.4 Investment supporting industrial transition 3.5 Investment supporting just transition 3.6 Strategic investment \u2014 Number and volume of operations contributing to the provision of critical infrastructure \u2014 Number and volume of operations contributing to investment in cybersecurity, space and defence 4. Sustainable infrastructure 4.1 Energy: Additional renewable and other safe and sustainable zero and low-emission energy generation capacity installed (in megawatts (MW)) 4.2 Energy: Number of households, number of public and commercial premises with improved energy consumption classification 4.3 Energy: Estimated energy savings generated by the projects (in kilowatt-hours (kWh)) 4.4 Energy: Annual green-house gas emissions reduced/avoided in tonnes of CO2 equivalent 4.5 Energy: Volume of investment in the development, smartening and modernisation of sustainable energy infrastructure 4.6 Digital: Additional households, enterprises or public buildings with broadband access of at least 100 Mbps upgradable to gigabit speed, or number of WIFI-hotspots created 4.7 Transport: Investment mobilised, in particular in TEN-T \u2014 Number of cross-border and missing links projects (including projects relating to urban nodes, regional cross-border rail connections, multimodal platforms, maritime ports, inland ports, connections to airports and rail-road terminals of the TEN-T core and comprehensive network) \u2014 Number of projects contributing to the digitisation of transport, in particular through the deployment of European Rail Traffic Management System (ERTMS), River Information System (RIS), Intelligent Transportation System (ITS), vessel traffic monitoring and information system (VTMIS)/e-maritime services and Single European Sky ATM Research (SESAR) \u2014 Number of alternative fuel supply points built or upgraded \u2014 Number of projects contributing to the safety of transport 4.8 Environment: Investment contributing to the implementation of plans and programmes required by the Union environmental acquis relating to air quality, water, waste and nature 5. Research, innovation and digitisation 5.1 Contribution to the objective of 3 % of the Union\u2019s gross domestic product (GDP) invested in research, development and innovation 5.2 Number of enterprises supported by size carrying out research and innovation projects 6. SMEs 6.1 Number of enterprises supported by size (micro, small, medium-sized and small mid-cap companies) 6.2 Number of enterprises supported by stage (early, growth/expansion) 6.3 Number of enterprises supported by Member State and region at NUTS 2 level 6.4 Number of enterprises supported by sectors by statistical classification of economic activities in the European Union (NACE) code 6.5 Percentage of investment volume under the SME policy window directed towards SMEs 7. Social investment and skills 7.1 Social infrastructure: Capacity and access to supported social infrastructure by sector: housing, education, health, other 7.2 Microfinance and social enterprise finance: Number of microfinance recipients and social enterprises supported 7.3 Skills: Number of individuals acquiring new skills or having their skills validated and certified: formal, education and training qualification 8. InvestEU Advisory Hub 8.1 Number of engagements of the InvestEU Advisory Hub to provide advisory support, by sector and Member State ANNEX IV THE INVESTEU PROGRAMME \u2013 PREDECESSOR INSTRUMENTS A. Equity instruments: \u2014 European Technology Facility (ETF98): Council Decision 98/347/EC of 19 May 1998 on measures of financial assistance for innovative and job-creating small and medium-sized enterprises (SMEs) - the growth and employment initiative (OJ L 155, 29.5.1998, p. 43) \u2014 Technology Transfer Pilot project (TTP): Commission decision adopting a complementary financing decision concerning the financing of actions of the activity \u2018Internal market of goods and sectoral policies\u2019 of the Directorate-General Enterprises & Industry for 2007 and adopting the framework decision concerning the financing of the preparatory action \u2018The EU assuming its role in a globalised world\u2019 and of four pilot projects \u2018Erasmus young entrepreneurs\u2019, \u2018Measures to promote cooperation and partnerships between micro and SMEs\u2019, \u2018Technological Transfer\u2019 and \u2018European Destinations of excellence\u2019 of the Directorate-General Enterprises & Industry for 2007 \u2014 European Technology Facility (ETF01): Council Decision 2000/819/EC of 20 December 2000 on a multiannual programme for enterprise and entrepreneurship, and in particular for small and medium-sized enterprises (SMEs) (2001-2005) (OJ L 333, 29.12.2000, p. 84) \u2014 Competitiveness and Innovation Programme High Growth and Innovative SME Facility (CIP GIF): Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007 to 2013) (OJ L 310, 9.11.2006, p. 15) \u2014 Connecting Europe Facility (CEF): Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010 (OJ L 348, 20.12.2013, p. 129) as amended by Regulation (EU) 2015/1017 of the European Parliament and of the Council of 25 June 2015 on the European Fund for Strategic Investments, the European Investment Advisory Hub and the European Investment Project Portal and amending Regulations (EU) No 1291/2013 and (EU) No 1316/2013 \u2014 the European Fund for Strategic Investments (OJ L 169, 1.7.2015, p. 1) \u2014 COSME Equity Facility for Growth (COSME EFG): Regulation (EU) No 1287/2013 of the European Parliament and of the Council of 11 December 2013 establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (COSME) (2014 - 2020) and repealing Decision No 1639/2006/EC (OJ L 347, 20.12.2013, p. 33) \u2014 InnovFin Equity: \u2014 Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104); \u2014 Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in \u201cHorizon 2020 - the Framework Programme for Research and Innovation (2014-2020)\u201d and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81); \u2014 Council Decision 2013/743/EU of 3 December 2013 establishing the specific programme implementing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (OJ L 347, 20.12.2013, p. 965) \u2014 EaSI Capacity Building Investments Window: Regulation (EU) No 1296/2013 of the European Parliament and of the Council of 11 December 2013 on a European Union Programme for Employment and Social Innovation (\u201cEaSI\u201d) and amending Decision No 283/2010/EU establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 347, 20.12.2013, p. 238) B. Guarantee instruments: \u2014 SME Guarantee Facility \u201998 (SMEG98): Council Decision 98/347/EC of 19 May 1998 on measures of financial assistance for innovative and job-creating small and medium-sized enterprises (SMEs) - the growth and employment initiative (OJ L 155, 29.5.1998, p. 43). \u2014 SME Guarantee Facility \u201901 (SMEG01): Council Decision 2000/819/EC of 20 December 2000 on a multiannual programme for enterprise and entrepreneurship, and in particular for small and medium-sized enterprises (SMEs) (2001-2005) (OJ L 333, 29.12.2000, p. 84) \u2014 Competitiveness and Innovation Programme SME Guarantee Facility \u201907 (CIP SMEG07): Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007 to 2013) (OJ L 310, 9.11.2006, p. 15) \u2014 European Progress Microfinance Facility \u2013 Guarantee (EPMF-G): Decision No 283/2010/EU of the European Parliament and of the Council of 25 March 2010 establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 87, 7.4.2010, p. 1) \u2014 Risk Sharing Finance Facility Risk-Sharing Instrument (RSI): \u2014 Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) Statements by the Commission (OJ L 412, 30.12.2006, p. 1) \u2014 Council Decision 2006/971/EC of 19 December 2006 concerning the Specific Programme Cooperation implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (OJ L 400, 30.12.2006, p. 86) \u2014 Council Decision 2006/974/EC of 19 December 2006 on the Specific Programme: Capacities implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (OJ L 400, 30.12.2006, p. 299) \u2014 EaSI Guarantee Instrument: Regulation (EU) No 1296/2013 of the European Parliament and of the Council of 11 December 2013 on a European Union Programme for Employment and Social Innovation (\u201cEaSI\u201d) and amending Decision No 283/2010/EU establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 347, 20.12.2013, p. 238) \u2014 COSME Loan Guarantee Facility (COSME LGF): Regulation (EU) No 1287/2013 of the European Parliament and of the Council of 11 December 2013 establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (COSME) (2014 - 2020) and repealing Decision No 1639/2006/EC (OJ L 347, 20.12.2013, p. 33) \u2014 InnovFin Debt: \u2014 Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in \u201cHorizon 2020 - the Framework Programme for Research and Innovation (2014-2020)\u201d and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81) \u2014 Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104) \u2014 Council Decision 2013/743/EU of 3 December 2013 establishing the specific programme implementing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (OJ L 347, 20.12.2013, p. 965) \u2014 Cultural and Creative Sectors Guarantee Facility (CCS GF): Regulation (EU) No 1295/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Creative Europe Programme (2014 to 2020) and repealing Decisions No 1718/2006/EC, No 1855/2006/EC and No 1041/2009/EC (OJ L 347, 20.12.2013, p. 221) \u2014 Student Loan Guarantee Facility (SLGF): Regulation (EU) No 1288/2013 of the European Parliament and of the Council of 11 December 2013 establishing \u201cErasmus+\u201d: the Union programme for education, training, youth and sport and repealing Decisions No 1719/2006/EC, No 1720/2006/EC and No 1298/2008/EC (OJ L 347, 20.12.2013, p. 50) \u2014 Private Finance for Energy Efficiency (PF4EE): Regulation (EU) No 1293/2013 of the European Parliament and of the Council of 11 December 2013 on the establishment of a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EC) No 614/2007 (OJ L 347, 20.12.2013, p. 185) C. Risk-sharing instruments: \u2014 Risk Sharing Finance Facility (RSFF): Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) Statements by the Commission (OJ L 412, 30.12.2006, p. 1) \u2014 InnovFin: \u2014 Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104) \u2014 Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in \u201cHorizon 2020 - the Framework Programme for Research and Innovation (2014-2020)\u201d and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81) \u2014 Connecting Europe Facility Debt Instrument (CEF DI): Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010 (OJ L 348, 20.12.2013, p. 129) \u2014 Natural Capital Financing Facility (NCFF): Regulation (EU) No 1293/2013 of the European Parliament and of the Council of 11 December 2013 on the establishment of a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EC) No 614/2007 (OJ L 347, 20.12.2013, p. 185) D. Dedicated investment vehicles: \u2014 European Progress Microfinance Facility \u2013 Fonds commun de placement \u2013 fonds d\u2019investissement sp\u00e9cialis\u00e9 (EPMF FCP-FIS): Decision No 283/2010/EU of the European Parliament and of the Council of 25 March 2010 establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 87, 7.4.2010, p. 1) \u2014 Marguerite: \u2014 Regulation (EC) No 680/2007 of the European Parliament and of the Council of 20 June 2007 laying down general rules for the granting of Community financial aid in the field of the trans-European transport and energy networks (OJ L 162, 22.6.2007, p. 1) \u2014 Commission Decision C(2010)0941 of 25 February 2010 on European Union participation in the 2020 European Fund for Energy, Climate Change and Infrastructure (the Marguerite Fund) \u2014 European Energy Efficiency Fund (EEEF): Regulation (EU) No 1233/2010 of the European Parliament and of the Council of 15 December 2010 amending Regulation (EC) No 663/2009 establishing a programme to aid economic recovery by granting Community financial assistance to projects in the field of energy (OJ L 346, 30.12.2010, p. 5) ANNEX V MARKET FAILURES, SUBOPTIMAL INVESTMENT SITUATIONS, ADDITIONALITY AND EXCLUDED ACTIVITIES A. Market failures, suboptimal investment situations and additionality In accordance with Article 209 of the Financial Regulation, the EU guarantee shall address market failures or suboptimal investment situations (point (a) of Article 209(2) of the Financial Regulation) and shall achieve additionality by preventing the replacement of potential support and investment from other public or private sources (point (b) of Article 209(2) of the Financial Regulation). In order to comply with points (a) and (b) of Article 209(2) of the Financial Regulation, the financing and investment operations benefitting from the EU guarantee shall fulfil the following requirements laid down in points 1 and 2: 1. Market failures and suboptimal investment situations To address market failures or suboptimal investment situations as referred to in point (a) of Article 209(2) of the Financial Regulation, the investments targeted by the financing and investment operations shall include one of following features: (a) Have the nature of a public good for which the operator or company cannot capture sufficient financial benefits (such as education and skills, healthcare and accessibility, security and defence, and infrastructure available at no or negligible cost). (b) Externalities which the operator or company generally fails to internalise, such as R&D investment, energy efficiency, climate or environmental protection. (c) Information asymmetries, in particular in the case of SMEs and small mid-cap companies, including higher risk levels related to early stage firms, firms with mainly intangible assets or insufficient collateral, or firms focusing on higher risk activities. (d) Cross-border infrastructure projects and related services or funds that invest on a cross-border basis to address the fragmentation of the internal market and to enhance coordination within the internal market. (e) Exposure to higher levels of risks in certain sectors, countries or regions beyond levels that private financial actors are able or willing to accept, including where the investment would not have been undertaken or would not have been undertaken to the same extent because of its novelty or because of risks associated with innovation or unproven technology. (f) New or complex market failures or suboptimal investment situations in accordance with point (a)(iii) of Article 9(1) of this Regulation. 2. Additionality Financing and investment operations shall fulfil both aspects of additionality as referred to in point (b) of Article 209(2) of the Financial Regulation. That means that the operations would not have been carried out or would not have been carried out to the same extent by other public or private sources without support from the InvestEU Fund. For the purposes of this Regulation, those operations shall be understood as financing and investment operations having to meet the following two criteria: (1) to be considered additional to the private sources referred to in point (b) of Article 209(2) of the Financial Regulation, the InvestEU Fund shall support the financing and investment operations of the implementing partners by targeting investments which, due to their characteristics (public good nature, externalities, information asymmetries, socio-economic cohesion considerations or other), are unable to generate sufficient market-level financial returns or are perceived to be too risky (compared to the risk levels that the relevant private entities are willing to accept). Because of those characteristics, such financing and investment operations cannot access market financing at reasonable conditions in terms of pricing, collateral requirements, the type of finance, the tenor of financing provided or other conditions, and would not be undertaken in the Union at all or to the same extent without public support; (2) to be considered additional to existing support from other public sources referred to in point (b) of Article 209(2) of the Financial Regulation the InvestEU Fund shall only support financing and investment operations for which the following conditions apply: (a) the financing and investment operations would not have been carried out or would not have been carried out to the same extent by the implementing partner without support from the InvestEU Fund; and (b) the financing and investment operations would not have been carried out or would not have been carried out to the same extent in the Union under other existing public instruments, such as shared management financial instruments that operate at regional or national level, although the complementary use of InvestEU Fund and other public sources has to be possible, in particular where Union added value can be achieved and where the use of public sources to achieve policy objectives in an efficient manner can be optimised. To demonstrate that the financing and investment operations benefitting from the EU guarantee are additional to the existing market and to existing other public support, the implementing partners shall provide information that demonstrates the presence of at least one of the following features: (a) support through subordinated positions in relation to other public or private lenders or within the funding structure; (b) support through equity and quasi-equity or through debt with long tenors, pricing, collateral requirements or other conditions not sufficiently available on the market or from other public sources; (c) support to operations that carry a higher risk profile than the risk generally accepted by the implementing partner\u2019s own standard activities or support to implementing partners in exceeding own capacity to support such operations; (d) participation in risk-sharing mechanisms targeting policy areas that exposes the implementing partner to higher risk levels compared to the levels generally accepted by the implementing partner or that private financial actors are able or willing to accept; (e) support that catalyses or crowds in additional private or public financing and is complementary to other private and commercial sources, in particular from traditionally risk-averse investor classes or institutional investors, as a result of the signalling effect of the support from the InvestEU Fund; (f) support through financial products not available or not offered to a sufficient level in the targeted countries or regions due to missing, underdeveloped or incomplete markets. For intermediated financing and investment operations, in particular for SME support, additionality shall be verified at the level of the intermediary rather than at the level of the final recipient. Additionality shall be deemed to exist when InvestEU Fund supports a financial intermediary in setting up a new portfolio with a higher level of risk or increasing the volume of activities that are already highly risky as compared with the risk levels that private and public financial actors are currently able or willing to accept in the targeted countries or regions. The EU guarantee shall not be granted for supporting refinancing operations (such as replacing existing loan agreements or other forms of financial support for projects which have already partially or fully materialised), except in specific exceptional and well justified circumstances in which it is demonstrated that the operation under the EU guarantee will enable a new investment in an eligible area for financing and investment operations under Annex II of an amount, additional to customary volume of activity by the implementing partner or financial intermediary, at least equivalent to the amount of the operation that fulfils the eligibility criteria set out in this Regulation. Such refinancing operations shall respect the requirements set out in Section A of this Annex regarding market failure, suboptimal investment situations and additionality. B. Excluded activities The InvestEU Fund shall not support: (1) activities which limit individual rights and freedoms or that violate human rights (2) in the area of defence activities, the use, development, or production of products and technologies that are prohibited by applicable international law (3) tobacco-related products and activities (production, distribution, processing and trade) (4) activities excluded from financing pursuant to the relevant provisions of the Horizon Europe Regulation: research on human cloning for reproductive purposes; activities intended to modify the genetic heritage of human beings which could make such changes heritable; and activities to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer (5) gambling (production-, construction-, distribution-, processing-, trade- or software-related activities) (6) sex trade and related infrastructure, services and media (7) activities involving live animals for experimental and scientific purposes insofar as compliance with the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (1) cannot be guaranteed (8) real estate development activity, such as an activity with a sole purpose of renovating and re-leasing or re-selling existing buildings as well as building new projects; however, activities in the real estate sector that are related to the specific objectives of the InvestEU Programme as specified in Article 3(2) and to the areas eligible for financing and investment operations under Annex II, such as investments in energy efficiency projects or social housing, shall be eligible (9) financial activities such as purchasing or trading in financial instruments. In particular, interventions targeting buy-out intended for asset stripping or replacement capital intended for asset stripping shall be excluded (10) activities forbidden by applicable national legislation (11) the decommissioning, operation, adaptation or construction of nuclear power stations (12) investments related to mining or to the extraction, processing, distribution, storage or combustion of solid fossil fuels and oil, as well as investments related to the extraction of gas. This exclusion does not apply to: (a) projects where there is no viable alternative technology; (b) projects related to pollution prevention and control; (c) projects equipped with carbon capture and storage or carbon capture and utilisation installations; industrial or research projects that lead to substantial reductions of greenhouse gas emissions as compared with the applicable EU Emission Trading System benchmarks (13) investments in facilities for the disposal of waste in landfill. This exclusion does not apply to investments in: (a) on-site landfill facilities that are an ancillary element of an industrial or mining investment project and where it has been demonstrated that landfilling is the only viable option to treat the industrial or mining waste produced by the activity concerned itself; (b) existing landfill facilities to ensure the utilisation of landfill gas and to promote landfill mining and the reprocessing of mining waste (14) investments in mechanical biological treatment (MBT) plants. This exclusion does not apply to investments to retrofit existing MBT plants for waste-to-energy purposes or recycling operations of separated waste such as composting and anaerobic digestion (15) investments in incinerators for the treatment of waste. This exclusion does not apply to investments in: (a) plants exclusively dedicated to treating non-recyclable hazardous waste; (b) existing plants, where the investment is for the purpose of increasing energy efficiency, capturing exhaust gases for storage or use or recovering materials from incineration ashes, provided such investments do not result in an increase of the plants\u2019 waste processing capacity. The implementing partners shall remain responsible for ensuring compliance of financing and investment operations with the exclusion criteria set out in this Annex at signature of the relevant agreement, for monitoring such compliance during the implementation of the project and for undertaking appropriate remedial actions where relevant. (1) OJ L 222, 24.8.1999, p. 31.", "summary": "InvestEU Programme (2021-2027) InvestEU Programme (2021-2027) SUMMARY OF: Regulation (EU) 2021/523 establishing the InvestEU Programme WHAT IS THE AIM OF THE REGULATION? It establishes the InvestEU programme comprising 3 building blocks: the InvestEU Fund, providing an EU guarantee to support financing of and investment in internal EU policies; the InvestEU Advisory Hub, supporting project development, access to finance and capacity-building assistance; the InvestEU Portal, giving visibility to projects seeking finance and information on investment opportunities. KEY POINTS The InvestEU programme\u2019s general aim is to support financing that contributes to: competitiveness, including research, innovation and digitisation; economic growth, sustainability and employment; social resilience, inclusiveness and innovation; scientific and technological advancement, including culture, education and training; the integration of capital markets and a stronger internal market; economic, social and territorial cohesion; sustainable and inclusive recovery of the EU economy, including capital support for small and medium-sized enterprises (SMEs), after the Covid-19 crisis. The programme uses 4 specific policy areas (through 4 dedicated \u2018windows\u2019), each with specific EU and national parts (\u2018compartments\u2019) to address market failures or suboptimal investment situations: sustainable infrastructure ranging from transport, energy and digital connectivity to the circular economy and innovative technologies; research, innovation and digitisation, including product development and support for market enablers; financing for SMEs, including innovative companies and those in the cultural and creative sectors; social investment and skills covering microfinance, social enterprises, health, gender equality, education, training and other social services. These are supported by: a just transition scheme with investments to address the social, economic and environmental challenges of meeting the EU\u2019s 2030 climate targets and 2050 goal of climate neutrality (see summary); strategic investments in important projects of common European interest, such as defence, space, cybersecurity, the green transition, the digital transition and strengthening strategic value chains. InvestEU has a budgetary guarantee of \u20ac26.2 billion (in current prices) funded by NextGenerationEU resources and the multiannual financial framework (2021-2027). The guarantee can be increased by contributions from EU Member States and non-EU countries. It is split as follows: \u20ac14.8 billion for measures to support the post-Covid-19 economic recovery under the EU\u2019s Recovery and Resilience Facility set up under Regulation (EU) 2021/241 (see summary); \u20ac11.3 billion for the 4 specific policy areas listed above. The European Commission and the European Investment Bank Group (EIBG) form a partnership under which the EIBG has specific tasks, to: support the implementation of the InvestEU programme; foster its consistency, inclusivity, additionality* and efficient deployment. Other national promotional banks and institutions and international financial institutions can take part in the programme. The Commission will: select implementing partners* in addition to the EIB; conclude a guarantee agreement with each partner covering items such as the amount and terms of the financial contribution, payment conditions and key performance indicators. To qualify for InvestEU Fund support, financing and investment operations must: comply with various conditions set out in the EU\u2019s Financial Regulation (Regulation (EU, Euratom) 2018/1046 \u2014 see summary); contribute to the EU\u2019s policy objectives and be an eligible area under Annex II (energy, transport infrastructure, environment and resources, digital connectivity, research, development and innovation, digital technologies, SMEs, cultural and creative sectors, tourism, rehabilitation of industrial sites, sustainable land and water use, bioeconomy, social investment, defence, space, seas and oceans); not feature on the list of excluded activities in Annex V (B), such as gambling, tobacco, real estate, oil, fossil fuels or violations of human rights; be consistent with the investment guidelines. The InvestEU Fund may also support projects and operations in non-EU countries subject to certain conditions. The EU guarantee: may be used towards risk coverage for various types of financing (loans, guarantees, capital market instruments or other forms of credit) provided by the implementing partners; covers for debt: all outstanding principal and interest due to the implementing partner, restructuring losses and losses from currency fluctuations, apart from the euroequity or quasi-equity investments: amounts invested and associated funding costs and losses from currency fluctuations, apart from the eurofunding or guarantees by an implementing partner to another financial institution: amounts used and associated costs. The regulation establishes a governance structure which consists of the following. The Advisory Board meets at least twice a year and advises the Commission and the Steering Board on the design of financial products, market developments, conditions and failures and suboptimal investments. The Steering Board provides strategic and operational guidance for the implementing partners, applies the Commission\u2019s risk methodological framework and oversees the implementation of the InvestEU programme. The Scoreboard contains various indicators that implementing partners provide, such as a description of the proposed financing and impact of the investment, so the Investment Committee can carry out an independent, transparent and harmonised assessment of requests for use of the EU guarantee. The Investment Committee is a fully independent body of experts that examines the financing and investment proposals submitted under the 4 \u2018windows\u2019 and checks whether they meet the regulation\u2019s conditions and whether they would benefit from support under the EU guarantee. Policy checks are carried out by the Commission to confirm proposed financing and investment operations from implementing partners, apart from the EIB, comply with EU law and policies. The InvestEU Advisory Hub, established by the Commission: provides advisory support to identify, prepare, develop, structure, procure and implement investment projects; helps project promoters and intermediaries to implement their financing and investment activities; acts as a central point of entry, managed by the Commission, for project development assistance for public authorities and project promoters, including additional information on investment guidelines; is available to public and private project promoters, including SMEs and start-ups, public authorities, national promotional banks and institutions and financial and non-financial intermediaries. The InvestEU Portal, established by the Commission: is an easily accessible and user-friendly database providing relevant information for each project; provides a channel for promoters seeking finance to make their projects visible to potential investors. The regulation establishes accountability, monitoring, evaluation and transparency requirements as follows. Accountability. The European Parliament or the Council may ask the Chairperson of the Steering Board to report on the InvestEU Fund\u2019s performance and reply orally or in writing to questions. Monitoring and reporting. Annex III contains a detailed list of key performance and monitoring indicators. Implementing partners use these in their 6-monthly reports to the Commission, which in turn reports annually on the InvestEU programme\u2019s performance. The EIB reports annually on investment barriers. Evaluation. The Commission: will submit an interim evaluation report on the programme to the European Parliament and the Council by 30 September 2024will present the 2 institutions with its final evaluation report, in particular on use of the EU guarantee, by 31 December 2031 at the latest. It will also send its conclusions to the European Economic and Social Committee and the European Committee of the Regions. Transparency. Implementing and advisory partners must acknowledge EU funding by providing targeted information to multiple audiences, including the media and the public. The Commission organises information and communication activities. The regulation: gives the Commission the power to adopt delegated acts; amends Regulation (EU) 2015/1017 on the European Fund for Strategic Investments (see summary). FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND The InvestEU programme brings under one umbrella many different forms of EU financing. This makes funding for investment projects simpler, more efficient and more flexible and helps meet the EU\u2019s twin goals of a green transition and digital transformation. The EU guarantee is used to leverage substantial private and public long-term funds to contribute to Europe\u2019s economic and social recovery by aligning investors with EU policy priorities. Member States may use InvestEU to implement their national plans under the Recovery and Resilience Facility. It is estimated the guarantee could mobilise total investment across the EU of over \u20ac372 billion by 2027, of which 30% will go towards climate policies. The InvestEU programme builds on the successful model of the investment plan for Europe, known as the Juncker Plan, which mobilised more than \u20ac500 billion between 2015 and 2020. For more information, see: InvestEU (European Commission). KEY TERMS Additionality: under EFSI (the European Fund for Strategic Investments), this term means support for operations which address market failures or suboptimal investment situations and which could not have been carried out in the period during which the EU guarantee can be used, or not to the same extent, by the EIB Group or under existing EU financial instruments without EFSI support. Implementing partner: an eligible counterpart, such as a national or international financial institution or promotional bank with whom the Commission has concluded an agreement. MAIN DOCUMENT Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, pp. 30-89) RELATED DOCUMENTS Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, pp. 17-75) Commission Delegated Regulation (EU) 2021/1078 of 14 April 2021 supplementing Regulation (EU) 2021/523 of the European Parliament and of the Council by setting out the investment guidelines for the InvestEU Fund (OJ L 234, 2.7.2021, pp. 18-66) Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 The European Green Deal (COM(2019) 640 final, 11.12.2019) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222) Regulation (EU) 2015/1017 of the European Parliament and of the Council of 25 June 2015 on the European Fund for Strategic Investments, the European Investment Advisory Hub and the European Investment Project Portal and amending Regulations (EU) No 1291/2013 and (EU) No 1316/2013 \u2014 the European Fund for Strategic Investments (OJ L 169, 1.7.2015, pp. 1-38) Successive amendments to Regulation (EU) 2015/1017 have been incorporated into the original text. This consolidated version is of documentary value only. last update 09.06.2021"}
{"article": "18.2.2021 EN Official Journal of the European Union L 57/17 REGULATION (EU) 2021/241 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 February 2021 establishing the Recovery and Resilience Facility THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the third paragraph of Article 175 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) In accordance with Articles 120 and 121 of the Treaty on the Functioning of the European Union (TFEU), Member States are required to conduct their economic policies with a view to contributing to the achievement of the objectives of the Union and in the context of the broad guidelines that the Council formulates. Article 148 TFEU provides that Member States are to implement employment policies that take into account the guidelines for employment. The coordination of the economic policies of the Member States is therefore a matter of common concern. (2) Article 175 TFEU provides, inter alia, that Member States are to coordinate their economic policies in such a way as to attain the objectives on economic, social and territorial cohesion set out in Article 174 TFEU. (3) Article 174 TFEU provides that, in order to promote its overall harmonious development, the Union is to develop and pursue actions that lead to the strengthening of its economic, social and territorial cohesion. It further provides that the Union shall, in particular, aim to reduce disparities between the levels of development of the various regions and the backwardness of the least favoured regions. Efforts to reduce disparities should in particular benefit islands and outermost regions. The different starting positions and specificities of regions should be taken into consideration in the implementation of Union policies. (4) At Union level, the European Semester for economic policy coordination (European Semester), including the principles of the European Pillar of Social Rights, is the framework to identify national reform priorities and monitor their implementation. In addition to measures that strengthen the competiveness, growth potential and sustainable public finances, reforms based on solidarity, integration, social justice and a fair distribution of wealth should also be introduced with the aim of creating quality employment and sustainable growth, ensuring equality of, and access to, opportunities and social protection, protecting vulnerable groups and improving the living standards of all Union citizens. Member States are to develop their own national multiannual investment strategies in support of those reforms, while bearing in mind the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (4) (the \u2018Paris Agreement\u2019), the National Energy and Climate Plans adopted in the framework of the Governance of the Energy Union and Climate Action as established by Regulation (EU) 2018/1999 of the European Parliament and of the Council (5), the just transition plans and the Youth Guarantee implementation plans, as well as the UN Sustainable Development Goals. Those strategies should be presented, where relevant, alongside the yearly National Reform Programmes as a way to outline and coordinate priority investment projects to be supported by national and/or Union funding. (5) The Commission outlined in the Annual Sustainable Growth Strategy 2020 and the European Semester Spring and Summer Package 2020 that the European Semester should help achieve the implementation of the European Green Deal, the European Pillar of Social Rights and the UN Sustainable Development Goals. (6) The COVID-19 outbreak in early 2020 changed the economic, social and budgetary outlook in the Union and in the world, calling for an urgent and coordinated response both at Union and national level in order to cope with the enormous economic and social consequences as well as asymmetrical effects for Member States. The COVID-19 crisis as well as the previous economic and financial crisis have shown that developing sound, sustainable and resilient economies as well as financial and welfare systems built on strong economic and social structures helps Member States respond more effectively and in a fair and inclusive way to shocks and recover more swiftly from them. A lack of resilience can also lead to negative spill-over effects of shocks between Member States or within the Union as a whole, thereby posing challenges to convergence and cohesion in the Union. Reductions in spending on sectors, such as the education sector, cultural sector and creative sector, and on healthcare can prove counterproductive to achieving a swift recovery. The medium and long-term consequences of the COVID-19 crisis will critically depend on how quickly Member States\u2019 economies and societies will recover from that crisis, which in turn depends on the available fiscal space of Member States to take measures to mitigate the social and economic impact of the crisis, and on the resilience of their economies and social structures. Sustainable and growth-enhancing reforms and investments that address structural weaknesses of Member State economies, and that strengthen the resilience, increase productivity and lead to higher competitiveness of Member States, will therefore be essential to set those economies back on track and reduce inequalities and divergences in the Union. (7) Past experiences have shown that investment is often drastically cut during crises. However, it is essential to support investment in this particular situation to speed up the recovery and strengthen long-term growth potential. A well-functioning internal market and investing in green and digital technologies, in innovation and research including in a knowledge-based economy, in the clean energy transition, and in boosting energy efficiency in housing and other key sectors of the economy are important to achieve fair, inclusive and sustainable growth, help create jobs, and reach EU climate neutrality by 2050. (8) In the context of the COVID-19 crisis, it is necessary to strengthen the current framework for the provision of support to Member States and provide direct financial support to Member States through an innovative tool. To that end, a recovery and resilience facility (the \u2018Facility\u2019) should be established to provide effective and significant financial support to step up the implementation of sustainable reforms and related public investments in the Member States. The Facility should be a dedicated instrument designed to tackle the adverse effects and consequences of the COVID-19 crisis in the Union. It should be comprehensive and should benefit from the experience gained by the Commission and the Member States from the use of the other instruments and programmes. Private investment could also be incentivised through public investment schemes, including financial instruments, subsidies and other instruments, provided State aid rules are complied with. (9) Reforms and investments under the Facility should help make the Union more resilient and less dependent by diversifying key supply chains and thereby strengthening the strategic autonomy of the Union alongside an open economy. Reforms and investments under the Facility should also generate European added value. (10) Recovery should be achieved, and the resilience of the Union and its Member States enhanced, through the support for measures that refer to the policy areas of European relevance structured in six pillars (the \u2018six pillars\u2019), namely: green transition; digital transformation; smart, sustainable and inclusive growth, including economic cohesion, jobs, productivity, competitiveness, research, development and innovation, and a well-functioning internal market with strong small and medium enterprises (SMEs); social and territorial cohesion; health, and economic, social and institutional resilience with the aim of, inter alia, increasing crisis preparedness and crisis response capacity; and policies for the next generation, children and the youth, such as education and skills. (11) The green transition should be supported by reforms and investments in green technologies and capacities, including in biodiversity, energy efficiency, building renovation and the circular economy, while contributing to the Union\u2019s climate targets, fostering sustainable growth, creating jobs and preserving energy security. (12) Reforms and investments in digital technologies, infrastructure and processes will increase the Union\u2019s competitiveness at global level and will also help make the Union more resilient, more innovative and less dependent by diversifying key supply chains. Reforms and investments should in particular promote the digitalisation of services, the development of digital and data infrastructure, clusters and digital innovation hubs and open digital solutions. The digital transition should also incentivise the digitalisation of SMEs. Investments in digital technologies should respect the principles of interoperability, energy efficiency and personal data protection, allow for the participation of SMEs and start-ups, and promote the use of open-source solutions. (13) Reforms and investments in smart, sustainable and inclusive growth, including economic cohesion, jobs, productivity, competitiveness, research, development and innovation, and a well-functioning internal market with strong SMEs should aim to enhance the growth potential and enable a sustainable recovery of the Union\u2019s economy. Those reforms and investments should also promote entrepreneurship, social economy, the development of sustainable infrastructure and transport, and industrialisation and reindustrialisation, and mitigate the effect of the COVID-19 crisis on the economy. (14) Reforms and investments in social and territorial cohesion should also contribute to fighting poverty and tackling unemployment in order for Member State economies to rebound while leaving nobody behind. Those reforms and investments should lead to the creation of high-quality and stable jobs, the inclusion and integration of disadvantaged groups, and enable the strengthening of social dialogue, infrastructure and services, as well as of social protection and welfare systems. (15) The COVID-19 crisis has also highlighted the importance of reforms and investments in health, and economic, social and institutional resilience, that aim to, inter alia, increase crisis preparedness and crisis response capacity, in particular by improving business and public service continuity, the accessibility and capacity of health and care systems, the effectiveness of public administration and national systems, including minimising the administrative burden, and the effectiveness of judicial systems as well as fraud prevention and anti-money laundering supervision. (16) Reforms and investments in the next generation, children and the youth are essential to promote education and skills, including digital skills, upskilling, reskilling and requalification of the active labour force, integration programmes for the unemployed, policies of investing in access and opportunity for children and the youth related to education, health, nutrition, jobs and housing, and policies that bridge the generational gap in line with the objectives of the Child Guarantee and Youth Guarantee. Those actions should ensure that the next generation of Europeans is not permanently affected by the impact of the COVID-19 crisis and that the generational gap is not further deepened. (17) Currently, no instrument foresees direct financial support linked to the achievement of results and to the implementation of reforms and public investments of the Member States in response to challenges identified in the context of the European Semester, including the European Pillar of Social Rights and the UN Sustainable Development Goals, and with a view to having a lasting impact on the productivity and economic, social and institutional resilience of the Member States. (18) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. Non-repayable financial support under the Facility should take the form of a sui generis Union contribution to be determined on the basis of a maximum financial contribution calculated for each Member State and taking into account the estimated total costs of the recovery and resilience plan, which should be paid based on the achievement of results by reference to milestones and targets of the recovery and resilience plans. Therefore, such contribution should be established in accordance with the sector-specific rules provided in this Regulation, pursuant to the rules on simplification relating to financing not linked to costs laid down in Article 125(1) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (6) (the \u2018Financial Regulation\u2019). Specific rules and procedure should therefore be laid down in this Regulation, subject to the general principles of budgetary management under the Financial Regulation, concerning the allocation, implementation and control of non-repayable financial support under this Regulation. Financing not linked to costs should apply at the level of payments from the Commission to Member States as beneficiaries, irrespective of the reimbursement in any form of financial contributions from Member States to final recipients. Member States should be able to use all forms of financial contributions, including simplified cost options. Without prejudice to the right of the Commission to take action in the event of fraud, corruption, conflicts of interests or double funding from the Facility and other Union programmes, payments should not be subject to controls on the costs actually incurred by the beneficiary. (19) In accordance with Council Regulation (EU) 2020/2094 (7) and within the limits of resources allocated therein, recovery and resilience measures under the Facility should be carried out to address the unprecedented impact of the COVID-19 crisis. Those additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation (EU) 2020/2094. (20) The Facility should support projects that respect the principle of additionality of Union funding. The Facility should not, unless in duly justified cases, be a substitute for recurring national expenditures. (21) Guaranteeing a high level of cybersecurity and trust in technologies is a pre-requisite for a successful digital transformation in the Union. In its conclusions of 1 and 2 October 2020, the European Council called on the Union and its Member States to make full use of the 5G cybersecurity toolbox adopted on 29 January 2020, and in particular to apply the relevant restrictions on high-risk suppliers for key assets defined as critical and sensitive in the Union coordinated risk assessments. The European Council underlined that potential 5G suppliers need to be assessed on the basis of common, objective criteria. (22) In order to foster synergies between the Facility, the InvestEU Programme established by a Regulation of the European Parliament and of the Council establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (the \u2018InvestEU Regulation\u2019) and the Technical Support Instrument established by Regulation (EU) 2021/240 of the European Parliament and of the Council (8), the recovery and resilience plans might include, within a certain ceiling, contributions to the Member State compartments under the InvestEU Programme and to the Technical Support Instrument, in compliance with this Regulation. (23) Reflecting the European Green Deal as Europe\u2019s sustainable growth strategy and the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement and the UN Sustainable Development Goals, the Facility is to contribute to the mainstreaming of climate action and environmental sustainability and to the achievement of an overall target of 30 % of Union budget expenditure supporting climate objectives. To that end, the measures supported by the Facility and included in recovery and resilience plans of the individual Member States should contribute to the green transition, including biodiversity, or to addressing the challenges resulting therefrom, and should account for an amount that represents at least 37 % of the recovery and resilience plan\u2019s total allocation based on the methodology for climate tracking set out in an annex to this Regulation. That methodology should be used accordingly for measures that cannot be directly assigned to an intervention field listed in the annex to this Regulation. If the Member State concerned and the Commission agree, it should be possible to increase the coefficients for support for the climate objectives to 40 % or 100 % for individual investments, as explained in the recovery and resilience plan, to take account of accompanying reform measures that credibly increase their impact on the climate objectives. To that end, it should be possible to increase the coefficients for support for the climate objectives up to a total amount of 3 % of the allocation of the recovery and resilience plan for individual investments. The Facility should support activities that fully respect the climate and environmental standards and priorities of the Union and the principle of \u2018do no significant harm\u2019 within the meaning of Article 17 of Regulation (EU) 2020/852 of the European Parliament and of the Council (9) (the principle of \u2018do no significant harm\u2019). (24) Reflecting the importance of tackling the dramatic loss of biodiversity, this Regulation should contribute to the mainstreaming of biodiversity action in Union policies. (25) Member States should ensure that the measures included in their recovery and resilience plans comply with the principle of \u2018do no significant harm\u2019 within the meaning of Article 17 of Regulation (EU) 2020/852. The Commission should provide technical guidance to that effect. The entry into force of the delegated acts referred to in point (d) of Article 3 of Regulation (EU) 2020/852 should not affect that guidance. (26) The measures supported by the Facility and included in the recovery and resilience plans of the individual Member States should also account for an amount that represents at least 20 % of the recovery and resilience plan\u2019s allocation for digital expenditure. To that end, Member States should calculate the coefficient for support for the digital objectives based on a methodology which reflects the extent to which support under the Facility makes a contribution to digital objectives. The coefficients for individual measures should be determined on the basis of the intervention fields established in an annex to this Regulation. The methodology should be used accordingly for measures that cannot be directly assigned to an intervention field. If the Member State concerned and the Commission agree, it should be possible to increase those coefficients to 40 % or 100 % for individual investments to take account of accompanying reforms that increase the impact of the measures on digital objectives. (27) For the purpose of determining the contribution of the relevant measures under the recovery and resilience plans to the climate and digital targets, it should be possible to count such measures under both objectives in accordance with their respective methodologies. (28) Women have been particularly affected by the COVID-19 crisis as they represent the majority of healthcare workers across the Union and balance unpaid care work with their employment responsibilities. The situation is especially difficult for single parents, 85 % of whom are women. Gender equality and equal opportunities for all, and the mainstreaming of those objectives should be taken into account and promoted throughout the preparation and implementation of recovery and resilience plans submitted pursuant to this Regulation. Investment in robust care infrastructure is also essential in order to ensure gender equality and the economic empowerment of women, in order to build resilient societies, combat precarious conditions in a female-dominated sector, boost job creation, prevent poverty and social exclusion, and in order to have a positive effect on Gross Domestic Product (GDP), as it allows more women to take part in paid work. (29) A mechanism to ensure the link between the Facility and sound economic governance should be established, allowing the Commission to make a proposal to the Council to suspend all or part of the commitments or payments under the Facility. The obligation of the Commission to propose a suspension should be suspended when and for as long as the so-called \u2018general escape clause\u2019 under the Stability and Growth Pact has been activated. In order to ensure uniform implementation and in view of the importance of the financial effects of the measures imposed, implementing powers should be conferred on the Council which should act on the basis of a Commission proposal. To facilitate the adoption of decisions which are required to ensure effective action in the context of the economic governance framework, reversed qualified majority voting should be used for the suspension of commitments. The competent committee of the European Parliament should be able to invite the Commission to discuss the application of that mechanism in the context of a structured dialogue to allow the European Parliament to express its views. In order for the Commission to give due consideration to the views expressed by the European Parliament, the structured dialogue should take place within four weeks after the Commission informing the European Parliament of the application of that mechanism. (30) The specific objective of the Facility should be to provide financial support with a view to achieving the milestones and targets of reforms and investments set out in recovery and resilience plans. That objective should be pursued in close cooperation with the Member States concerned. (31) By 31 July 2022, the Commission should present a review report on the implementation of the Facility to the European Parliament and to the Council. For that purpose, the Commission should take into account the common indicators and the recovery and resilience scoreboard provided under this Regulation as well as other available relevant information. The competent committee of the European Parliament might invite the Commission to present the main findings of its review report in the context of the recovery and resilience dialogue established under this Regulation. (32) To ensure their contribution to the objectives of the Facility, recovery and resilience plans should comprise measures for the implementation of reforms and public investment projects through a coherent package. Measures started from 1 February 2020 onwards should be eligible. Recovery and resilience plans should be consistent with the relevant country-specific challenges and priorities identified in the context of the European Semester, as well as challenges and priorities identified in the most recent Council recommendation on the economic policy of the euro area for Member States whose currency is the euro. Recovery and resilience plans should also be consistent with National Reform Programmes, National Energy and Climate Plans, just transition plans, the Youth Guarantee Implementation Plan and the partnership agreements and operational programmes adopted under the Union funds. To boost actions that fall within the priorities of the European Green Deal and the Digital Agenda, recovery and resilience plans should also set out measures that are relevant for the green and digital transitions. Such measures should enable a swift delivery of the targets, objectives and contributions set out in National Energy and Climate Plans and updates thereof. All supported activities should be pursued in full respect of the climate and environmental standards and priorities of the Union. Recovery and resilience plans should also respect the horizontal principles of the Facility. (33) Recovery and resilience plans should not affect the right to conclude or enforce collective agreements or to take collective action in accordance with the Charter of Fundamental Rights of the European Union, and Union and national law and practices. (34) Regional and local authorities can be important partners in the implementation of reforms and investments. In that regard, they should be appropriately consulted and involved, in accordance with the national legal framework. (35) Where a Member State is exempted from the monitoring and assessment in the context of the European Semester pursuant to Article 12 of Regulation (EU) No 472/2013 of the European Parliament and of the Council (10) or is subject to surveillance under Council Regulation (EC) No 332/2002 (11), it should be possible to apply this Regulation to the Member State concerned in relation to the challenges and priorities identified by those Regulations. (36) To inform the preparation and the implementation of the recovery and resilience plans by Member States, the Council should be able to discuss, in the context of the European Semester, the state of the recovery, resilience and adjustment capacity in the Union. That discussion should be based on the strategic and analytical information available to the Commission in the context of the European Semester and, if available, on the basis of the information on the implementation of the recovery and resilience plans in the preceding years. (37) In order to ensure a meaningful financial contribution commensurate to the actual needs of Member States to undertake and complete the reforms and investments included in the recovery and resilience plan, it is appropriate to establish a maximum financial contribution available to them under the Facility as non-repayable financial support. 70 % of that maximum financial contribution should be calculated on the basis of the population, the inverse of the GDP per capita and the relative unemployment rate of each Member State. 30 % of that maximum financial contribution should be calculated on the basis of the population, the inverse of the GDP per capita, and, in equal proportion, the change in real GDP in 2020 and the aggregated change in real GDP during the period 2020-2021 based on the Commission Autumn 2020 forecasts for data not available at the time of calculation, to be updated by 30 June 2022 with actual outturns. (38) It is necessary to establish a process for the submission of recovery and resilience plans by the Member States, and the content thereof. Member States should officially submit their recovery and resilience plans, as a rule, by 30 April, and could do so in a single integrated document together with their National Reform Programme. To ensure fast implementation of the Facility, Member States should be able to submit a draft recovery and resilience plan from 15 October of the preceding year. (39) In order to ensure the national ownership and a focus on relevant reforms and investments, Member States wishing to receive support should submit to the Commission a recovery and resilience plan that is duly reasoned and substantiated. That plan should detail how, taking into account the measures included therein, it represents a comprehensive and adequately balanced response to the economic and social situation of the Member State concerned, thereby contributing appropriately to the six pillars, taking into account the specific challenges of the Member State concerned. The recovery and resilience plan should set out the detailed set of measures for its monitoring and implementation, including targets and milestones and estimated costs, as well as the expected impact of the recovery and resilience plan on growth potential, job creation and economic, social and institutional resilience, including through the promotion of policies for children and the youth, and on the mitigation of the economic and social impact of the COVID-19 crisis, contributing to the implementation of the European Pillar of Social Rights, thereby enhancing the economic, social and territorial cohesion and convergence within the Union. It should also include measures that are relevant for the green transition, including biodiversity, and the digital transition. It should also include an explanation of how it contributes to effectively addressing the relevant country-specific challenges and priorities identified in the context of the European Semester, including fiscal aspects and recommendations made pursuant to Article 6 of Regulation (EU) No 1176/2011 of the European Parliament and of the Council (12). It should also include an explanation of how the recovery and resilience plan ensures that no measure for the implementation of reforms and investments included in that plan does significant harm to environmental objectives within the meaning of Article 17 of Regulation (EU) 2020/852 (the principle of \u2018do no significant harm\u2019). The recovery and resilience plan should set out the expected contribution to gender equality and equal opportunities for all as well as a summary of the conducted consultation process with relevant national stakeholders. The recovery and resilience plan should contain an explanation of the Member State\u2019s plans, systems and concrete measures to prevent, detect and correct conflicts of interest, corruption and fraud, and to avoid double funding from the Facility and other Union programmes. The recovery and resilience plan might also include cross-border or multi-country projects. Close cooperation between the Commission and the Member States should be sought and achieved throughout the process. (40) The implementation of the Facility should be carried out in line with the principle of sound financial management, including the effective prevention and prosecution of fraud, including tax fraud, tax evasion, corruption and conflicts of interest. (41) The Commission should assess the recovery and resilience plan proposed by each Member State and should act in close cooperation with the Member State concerned. The Commission should fully respect the national ownership of the plan and should therefore take into account the justifications and elements provided by the Member State concerned. The Commission should assess the relevance, effectiveness, efficiency and coherence of the recovery and resilience plan proposed by the Member State, based on the list of criteria set out in this Regulation. The Commission should assess the recovery and resilience plans proposed, and, where applicable, their updates, within two months of the official submission of the recovery and resilience plans. The Member State concerned and the Commission should be able to agree to extend that deadline by a reasonable period if necessary. (42) Appropriate guidelines should be set out in an annex to this Regulation to serve as a basis for the Commission to assess in a transparent and equitable manner the recovery and resilience plans and to determine the financial contribution in line with the objectives and any other relevant requirements laid down in this Regulation. In the interest of transparency and efficiency, a rating system for the assessment of the proposals for recovery and resilience plans should be established to that effect. The criteria related to the country-specific recommendations, to the strengthening of the growth potential, job creation and economic, social and institutional resilience, and to contributing to the implementation of the European Pillar of Social Rights, should require the highest score of the assessment. Effective contribution to the green and digital transitions should also be a prerequisite for a positive assessment. (43) In order to contribute to the preparation of high-quality recovery and resilience plans and assist the Commission in the assessment of the recovery and resilience plans submitted by the Member States and in the assessment of the degree of their achievement, provision should be made for the use of expert advice and, at the request of the Member State concerned, peer counselling and technical support. Member States might also request support under the Technical Support Instrument. Member States should be encouraged to foster synergies with recovery and resilience plans of other Member States. (44) For the purpose of simplification, the determination of the financial contribution should follow simple criteria. The financial contribution should be determined on the basis of the estimated total costs of the recovery and resilience plan proposed by the Member State concerned. (45) The Council should approve the assessment of the recovery and resilience plans by means of an implementing decision, based on a proposal by the Commission, which it should endeavour to adopt within four weeks of the adoption of that proposal. Provided that the recovery and resilience plan satisfactorily addresses the assessment criteria, the Member State concerned should be allocated the maximum financial contribution where the estimated total costs of the reform and investment included in the recovery and resilience plan is equal to, or higher than, the amount of the maximum financial contribution itself. The Member State concerned should instead be allocated an amount equal to the estimated total costs of the recovery and resilience plan where such estimated total costs are lower than the maximum financial contribution itself. No financial contribution should be awarded to the Member State if the recovery and resilience plan does not satisfactorily address the assessment criteria. The Council implementing decision should be amended, on a proposal by the Commission, to include the updated maximum financial contribution calculated on the basis of actual outturns in June 2022. The Council should adopt the relevant amending decision without undue delay. (46) To ensure that the financial support is frontloaded in the initial years after the COVID-19 crisis, and to ensure compatibility with the available funding for the Facility, the funds should be made available until 31 December 2023. To that end, it should be possible for 70 % of the amount available for non-repayable financial support to be legally committed by 31 December 2022 and 30 % between 1 January 2023 and 31 December 2023. By 31 December 2021, upon request of a Member State to be submitted together with the recovery and resilience plan, an amount of up to 13 % of the financial contribution and, where applicable, of up to 13 % of the loan of the Member State concerned can be paid in the form of a pre-financing within, to the extent possible, two months after the adoption by the Commission of the legal commitments. (47) Financial support for a Member State\u2019s recovery and resilience plan should be possible in the form of a loan, subject to the conclusion of a loan agreement with the Commission, on the basis of a duly substantiated request by the Member State concerned. Loans supporting the implementation of national recovery and resilience plans should be provided until 31 December 2023 and should be provided at maturities that reflect the longer-term nature of such spending. Pursuant to Article 5(2) of Council Decision (EU, Euratom) 2020/2053 (13), repayments should be scheduled, in accordance with the principle of sound financial management, in a manner that ensures the steady and predictable reduction of liabilities. Those maturities might diverge from the maturities of the funds the Union borrows to finance the loans on capital markets. Therefore, it is necessary to provide for the possibility to derogate from the principle set out in Article 220(2) of the Financial Regulation, according to which maturities of loans for financial assistance should not be transformed. (48) The request for loan support should be justified by the higher financial needs linked to additional reforms and investments included in the recovery and resilience plan, relevant in particular for the green and digital transitions, and by a higher cost of the recovery and resilience plan than the maximum financial contribution allocated via the non-repayable contribution. It should be possible to submit the request for loan support together with the submission of the recovery and resilience plan. Where the request for loan support is made at a different moment in time, it should be accompanied by a revised recovery and resilience plan with additional milestones and targets. To ensure that resources are frontloaded, Member States should request loan support by 31 August 2023. For the purposes of sound financial management, the total amount of all loan support granted under this Regulation should be capped. In addition, the maximum volume of the loan for each Member State should not exceed 6,8 % of its 2019 Gross National Income (GNI), as per data from Eurostat with cut off date May 2020. An increase of the capped amount should be possible in exceptional circumstances subject to available resources. For the same reason, it should be possible to disburse the loan in instalments against the fulfilment of results. The Commission should assess the request for loan support within two months. Acting on a Commission proposal, the Council should be able to approve that assessment by qualified majority by means of an implementing decision which the Council should endeavour to adopt within four weeks of the adoption of that Commission proposal. (49) It should be possible for a Member State to make a reasoned request to amend the recovery and resilience plan within the period of implementation, where objective circumstances justify such a course of action. Where the Commission considers that the reasons put forward by the Member State concerned justify such an amendment it should assess the new recovery and resilience plan within two months. The Member State concerned and the Commission should be able to agree to extend that deadline by a reasonable period if necessary. The Council should approve the assessment of the new recovery and resilience plan by means of an implementing decision, based on a proposal by the Commission, and which it should endeavour to adopt within four weeks of the adoption of the proposal. (50) Union institutions should do their utmost to reduce processing time in order to ensure the smooth and rapid implementation of the Facility. (51) For reasons of efficiency and simplification in the financial management of the Facility, Union financial support for recovery and resilience plans should take the form of financing based on the achievement of results measured by reference to milestones and targets indicated in the approved recovery and resilience plans. To that end, additional loan support should be linked to additional milestones and targets compared to those relevant for the financial support (that is, the non-repayable financial support). (52) The release of funds under the Facility is contingent on the satisfactory fulfilment of the relevant milestones and targets by the Member States set out in the recovery and resilience plans, the assessment of such plans having been approved by the Council. Before a decision authorising the disbursement of the financial contribution and, where applicable, of the loan, is adopted by the Commission, it should ask the Economic and Financial Committee for its opinion on the satisfactory fulfilment of the relevant milestones and targets by the Member States on the basis of a preliminary assessment by the Commission. In order for the Commission to take the opinion of the Economic and Financial Committee into account for its assessment, it should be delivered within four weeks of receiving the preliminary assessment by the Commission. In its deliberations, the Economic and Financial Committee shall strive to reach consensus. If, exceptionally, one or more Member States consider that there are serious deviations from the satisfactory fulfilment of the relevant milestones and targets, they may request the President of the European Council to refer the matter to the next European Council. The respective Member States should also inform the Council without undue delay, and the Council should, in turn, without delay inform the European Parliament. In such exceptional circumstances, no decision authorising the disbursement of the financial contribution and, where applicable, of the loan should be taken until the next European Council has exhaustively discussed the matter. That process should, as a rule, not take longer than three months after the Commission has asked the Economic and Financial Committee for its opinion. (53) For the purposes of sound financial management, while respecting the performance-based nature of the Facility, specific rules should be laid down for budget commitments, payments, suspension, and recovery of funds as well as the termination of agreements related to financial support. To ensure predictability, it should be possible for Member States to submit requests for payments twice a year. Payments should be made in instalments and be based on a positive assessment by the Commission of the implementation of the recovery and resilience plan by the Member State concerned. The Member States should take appropriate measures to ensure that the use of funds in relation to measures supported by the Facility complies with applicable Union and national law. In particular, they should ensure that fraud, corruption and conflicts of interests are prevented, detected and corrected, and that double funding from the Facility and other Union programmes is avoided. Suspension and the termination of agreements related to financial support as well as reduction and recovery of the financial contribution should be possible when the recovery and resilience plan has not been implemented in a satisfactory manner by the Member State concerned, or in the case of serious irregularities, meaning fraud, corruption and conflicts of interest in relation to the measures supported by the Facility, or a serious breach of an obligation under the agreements related to financial support. Recovery should, where possible, be ensured through offsetting outstanding payments under the Facility. Appropriate contradictory procedures should be established to ensure that the decision by the Commission in relation to suspension and recovery of amounts paid as well as the termination of agreements related to financial support respects the right of Member States to submit observations. All payments of financial contributions to Member States should be made by 31 December 2026, with the exception of measures referred to in the second sentence of Article 1(3) of Regulation (EU) 2020/2094 and cases where, although the legal commitment has been entered, or the decision adopted, in compliance with the deadlines referred to in Article 3 of that Regulation, it is necessary for the Union to be able to honour its obligations towards the Member States, including as a result of a definitive judgment against the Union. (54) The Commission should ensure that the financial interests of the Union are effectively protected. While it is primarily the responsibility of the Member State itself to ensure that the Facility is implemented in compliance with relevant Union and national law, the Commission should be able to receive sufficient assurance from Member States in that regard. To that end, in implementing the Facility, the Member States should ensure the functioning of an effective and efficient internal control system and recover amounts unduly paid or misused. In that regard, Member States should be able to rely on their regular national budget management systems. Member States should collect standardised categories of data and information allowing the prevention, detection and correction of serious irregularities, meaning fraud, corruption and conflicts of interests, in relation to the measures supported by the Facility. The Commission should make available an information and monitoring system, including a single data-mining and risk-scoring tool, to access and analyse this data and information, with a view to a generalised application by the Member States. (55) The Commission, the European Anti-Fraud Office (OLAF), the Court of Auditors and, where applicable, the European Public Prosecutor\u2019s Office (EPPO) should be able to use the information and monitoring system within their competences and rights. (56) In order to facilitate the implementation of Member State arrangements that aim to avoid double funding from the Facility and other Union programmes, the Commission should make available information on the recipients of funds financed from the Union budget, in accordance with Article 38(1) of the Financial Regulation. (57) The Member States and the Commission should be allowed to process personal data only where necessary for the purpose of ensuring discharge, audit and control of the use of funds in relation to measures for the implementation of reforms and investment projects under the recovery and resilience plan. The personal data should be processed in accordance with Regulation (EU) 2016/679 (14) or (EU) 2018/1725 (15) of the European Parliament and of the Council, whichever of the two Regulations is applicable. (58) For the effective monitoring of implementation, Member States should report twice a year in the context of the European Semester on the progress made in the achievement of the recovery and resilience plan. Such reports prepared by the Member States concerned should be appropriately reflected in the National Reform Programmes, which should be used as a tool for reporting on progress towards completion of recovery and resilience plans. (59) Member States should be encouraged to seek the opinion of their national productivity boards and independent fiscal institutions on their recovery and resilience plans, including possible validation of elements of their recovery and resilience plan. (60) In order to ensure transparency and accountability in the implementation of the Facility, the Commission should transmit, subject to clearance of sensitive or confidential information, or to appropriate confidentiality arrangements if necessary, relevant documents and information simultaneously and on equal terms to the European Parliament and to the Council, such as the recovery and resilience plans, or their amendments, as submitted by the Member States, and the proposals for Council implementing decisions as made public by the Commission. (61) The competent committee of the European Parliament might every two months invite the Commission to discuss in a recovery and resilience dialogue matters that concern the implementation of the Facility, such as the recovery and resilience plans of the Member States, the assessment by the Commission, the main findings of the review report, the status of fulfilment of the milestones and targets, procedures related to payment and suspension, and any other relevant information and documentation provided by the Commission in relation to the implementation of the Facility. The Commission should take into account elements arising from the views expressed through the recovery and resilience dialogue, including the resolutions from the European Parliament if provided. (62) In order to ensure an efficient and coherent allocation of funds and to respect the principle of sound financial management, actions under this Regulation should be consistent with and be complementary to ongoing Union programmes, whilst avoiding double funding from the Facility and other Union programmes for the same expenditure. In particular, the Commission and the Member State should ensure, in all stages of the process, effective coordination in order to safeguard the consistency, coherence, complementarity and synergy among sources of funding. To that effect, Member States should be required to present the relevant information on existing or planned Union financing when submitting their recovery and resilience plans to the Commission. Financial support under the Facility should be additional to the support provided under other Union programmes and instruments, including the InvestEU Programme. Reforms and investment projects financed under the Facility should be able to receive funding from other Union programmes and instruments provided that such support does not cover the same cost. (63) The Commission should monitor the implementation of the Facility and measure the achievement of the objectives under this Regulation in a targeted and proportionate manner. When monitoring the implementation of the Facility, the Commission should ensure that data for monitoring the implementation of the activities and results are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements should be imposed on recipients of Union funding. By way of delegated acts, the Commission should set out the common indicators to be used for reporting on progress and for the purpose of monitoring and evaluation of the Facility and define a methodology for reporting social expenditure, including on children and the youth, under the Facility. (64) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (16), this Facility should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Facility on the ground. (65) A dedicated scoreboard should be established by way of a delegated act to display the progress of the implementation of the recovery and resilience plans of the Member States in each of the six pillars and the progress made as regards the implementation of the recovery and resilience plans in respect of the common indicators of the Facility. The scoreboard should be operational by December 2021 and should be updated by the Commission twice a year. (66) In order to ensure appropriate performance reporting and monitoring of the implementation of the Facility, including on social expenditure, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the dedicated scoreboard displaying the progress of the implementation and the common indicators to be used as well as the methodology for reporting social expenditure, including on children and the youth. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (67) The Commission should provide an annual report to the European Parliament and to the Council on the implementation of the Facility. That report should include information on the progress made by Member States under the recovery and resilience plans approved. It should also include information on the implementation of the milestones and targets, payments and suspensions, as well as on the contribution of the Facility to the climate and digital targets, common indicators and expenditure financed under the six pillars. (68) An independent evaluation looking at the achievement of the objectives of the Facility, the efficiency of the use of its resources and its added value should be carried out. Where appropriate, the evaluation should be accompanied by a proposal for amendments to this Regulation. An independent ex-post evaluation should, in addition, deal with the long-term impact of the Facility. (69) The assessment of the recovery and resilience plans to be implemented by the Member States and the corresponding financial support should be adopted by the Council by means of an implementing decision, on a proposal from the Commission. To that end, and in order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Council. Those implementing powers relating to the payment of the financial support upon fulfilment of the relevant milestones and targets should be conferred on and be exercised by the Commission in accordance the examination procedure of Regulation (EU) No 182/2011 of the European Parliament and of the Council (17). Taking into account the possible need for a prompt payment of financial support under the Facility, in accordance with the relevant provisions of Regulation (EU) No 182/2011, the Chair of the committee within the meaning of that Regulation should consider the possibility, for any draft implementing act, of shortening the time limit for convening the committee and the time limit for the committee to deliver its opinion. (70) After the adoption of an implementing decision, it should be possible for the Member State concerned and the Commission to agree on certain operational arrangements of a technical nature, detailing aspects of the implementation with respect to timelines, indicators for the milestones and targets, and access to underlying data. To ensure the continuous relevance of the operational arrangements in respect of the prevailing circumstances during the implementation of the recovery and resilience plan, it should be possible that the elements of such operational arrangements be modified by mutual consent. (71) Horizontal financial rules adopted by the European Parliament and the Council pursuant to Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation and provide for checks on the responsibility of financial actors. Rules adopted pursuant to Article 322 TFEU also include a general regime of conditionality for the protection of the Union\u2019s budget. (72) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (18), Council Regulations (EC, Euratom) No 2988/95 (19), (Euratom, EC) No 2185/96 (20) and (EU) 2017/1939 (21), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of fraud, corruption and conflicts of interests, and, where appropriate, the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, OLAF has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption, conflicts of interests or any other illegal activity affecting the financial interests of the Union. EPPO is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute fraud, corruption, conflicts of interests and other criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (22). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the Union\u2019s financial interests, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, EPPO and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (73) It should be possible for the Commission to engage in communication activities to ensure the visibility of Union funding and, as appropriate, to ensure that support under the Facility is communicated and acknowledged through a funding statement. (74) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives. (75) In order to allow for the prompt application of the measures provided for in this Regulation, it should enter into force on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS AND FINANCING Article 1 Subject matter This Regulation establishes the Recovery and Resilience Facility (the \u2018Facility\u2019). It lays down the objectives of the Facility, its financing, the forms of Union funding under it and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018Union funds\u2019 means funds covered by a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Border Management and Visa Instrument (the \u2018Common Provisions Regulation for 2021-2027\u2019); (2) \u2018financial contribution\u2019 means non-repayable financial support under the Facility that is available for allocation or that has been allocated to a Member State; (3) \u2018European Semester\u2019 means the process set out in Article 2-a of Council Regulation (EC) No 1466/97 (23); (4) \u2018milestones and targets\u2019 means measures of progress towards the achievement of a reform or an investment, with milestones being qualitative achievements and targets being quantitative achievements; (5) \u2018resilience\u2019 means the ability to face economic, social and environmental shocks or persistent structural changes in a fair, sustainable and inclusive way; and (6) \u2018do no significant harm\u2019 means not supporting or carrying out economic activities that do significant harm to any environmental objective, where relevant, within the meaning of Article 17 of Regulation (EU) 2020/852. Article 3 Scope The scope of application of the Facility shall refer to policy areas of European relevance structured in six pillars: (a) green transition; (b) digital transformation; (c) smart, sustainable and inclusive growth, including economic cohesion, jobs, productivity, competitiveness, research, development and innovation, and a well-functioning internal market with strong SMEs; (d) social and territorial cohesion; (e) health, and economic, social and institutional resilience, with the aim of, inter alia, increasing crisis preparedness and crisis response capacity; and (f) policies for the next generation, children and the youth, such as education and skills. Article 4 General and specific objectives 1. In line with the six pillars referred in Article 3 of this Regulation, the coherence and synergies they generate, and in the context of the COVID-19 crisis, the general objective of the Facility shall be to promote the Union\u2019s economic, social and territorial cohesion by improving the resilience, crisis preparedness, adjustment capacity and growth potential of the Member States, by mitigating the social and economic impact of that crisis, in particular on women, by contributing to the implementation of the European Pillar of Social Rights, by supporting the green transition, by contributing to the achievement of the Union\u2019s 2030 climate targets set out in point (11) of Article 2 of Regulation (EU) 2018/1999 and by complying with the objective of EU climate neutrality by 2050 and of the digital transition, thereby contributing to the upward economic and social convergence, restoring and promoting sustainable growth and the integration of the economies of the Union, fostering high quality employment creation, and contributing to the strategic autonomy of the Union alongside an open economy and generating European added value. 2. To achieve that general objective, the specific objective of the Facility shall be to provide Member States with financial support with a view to achieving the milestones and targets of reforms and investments as set out in their recovery and resilience plans. That specific objective shall be pursued in close and transparent cooperation with the Member States concerned. Article 5 Horizontal principles 1. Support from the Facility shall not, unless in duly justified cases, substitute recurring national budgetary expenditure and shall respect the principle of additionality of Union funding as referred to in Article 9. 2. The Facility shall only support measures respecting the principle of \u2018do no significant harm\u2019. Article 6 Resources from the European Union Recovery Instrument 1. Measures referred to in Article 1 of Regulation (EU) 2020/2094 shall be implemented under the Facility: (a) through an amount of up to EUR 312 500 000 000 as referred to in point (ii) of Article 2(2)(a) of Regulation (EU) 2020/2094 in 2018 prices, available for non-repayable financial support, subject to Article 3(4) and (7) of Regulation (EU) 2020/2094. As provided for in Article 3(1) of Regulation (EU) 2020/2094, those amounts shall constitute external assigned revenue for the purpose of Article 21(5) of the Financial Regulation; (b) through an amount of up to EUR 360 000 000 000 as referred to in point (b) of Article 2(2) of Regulation (EU) 2020/2094 in 2018 prices, available for loan support to Member States pursuant to Articles 14 and 15 of this Regulation, subject to Article 3(5) of Regulation(EU) 2020/2094. 2. The amounts referred to in point (a) of paragraph 1 may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities, which are required for the management of the Facility and the achievement of its objectives, in particular studies, meetings of experts, consultation of stakeholders, information and communication actions, including inclusive outreach actions, and corporate communication of the political priorities of the Union, insofar as they are related to the objectives of this Regulation, expenses linked to IT networks focusing on information processing and exchange, corporate information technology tools, and all other technical and administrative assistance expenses incurred by the Commission for the management of the Facility. Expenses may also cover the costs of other supporting activities such as quality control and monitoring of projects on the ground and the costs of peer counselling and experts for the assessment and implementation of reforms and investments. Article 7 Resources from shared management programmes and use of resources 1. Resources allocated to Member States under shared management may, at their request, be transferred to the Facility subject to the conditions set out in the relevant provisions of the Common Provisions Regulation for 2021-2027. The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation. Those resources shall be used exclusively for the benefit of the Member State concerned. 2. Member States may propose to include in their recovery and resilience plan, as estimated costs, the payments for additional technical support in accordance with Article 7 of Regulation (EU) 2021/240 and the amount of the cash contribution for the purpose of the Member State compartment pursuant to the relevant provisions of the InvestEU Regulation. Those costs shall not exceed 4 % of the recovery and resilience plan\u2019s financial total allocation, and the relevant measures, as set out in the recovery and resilience plan, shall respect the requirements of this Regulation. Article 8 Implementation The Facility shall be implemented by the Commission in direct management in accordance with the relevant rules adopted pursuant to Article 322 TFEU, in particular the Financial Regulation and the Regulation (EU, Euratom) 2020/2092 of the European Parliament and of the Council (24). Article 9 Additionality and complementary funding Support under the Facility shall be additional to the support provided under other Union programmes and instruments. Reforms and investment projects may receive support from other Union programmes and instruments provided that such support does not cover the same cost. Article 10 Measures linking the Facility to sound economic governance 1. The Commission shall make a proposal to the Council to suspend all or part of the commitments or payments where the Council decides in accordance with Article 126(8) or (11) TFEU that a Member State has not taken effective action to correct its excessive deficit, unless it has determined the existence of a severe economic downturn for the Union as a whole within the meaning of Articles 3(5) and 5(2) of Council Regulation (EC) No 1467/97 (25). 2. The Commission may make a proposal to the Council to suspend all or part of the commitments or payments in relation to any of the following cases: (a) where the Council adopts two successive recommendations in the same excessive imbalance procedure in accordance with Article 8(3) of Regulation (EU) No 1176/2011 on the grounds that a Member State has submitted an insufficient corrective action plan; (b) where the Council adopts two successive decisions in the same excessive imbalance procedure in accordance with Article 10(4) of Regulation (EU) No 1176/2011 establishing non-compliance by a Member State on the grounds that it has not taken the recommended corrective action; (c) where the Commission concludes that a Member State has not taken measures as referred to in Regulation (EC) No 332/2002 and as a consequence decides not to authorise the disbursement of the financial assistance granted to that Member State; (d) where the Council decides that a Member State does not comply with the macroeconomic adjustment programme referred to in Article 7 of Regulation (EU) No 472/2013, or with the measures requested by a Council decision adopted in accordance with Article 136(1) TFEU. Priority shall be given to the suspension of commitments; payments shall be suspended only when immediate action is sought and in the case of significant non-compliance. The decision to suspend payments shall apply to requests for payments submitted after the date of the decision to suspend. 3. A proposal by the Commission for a decision to suspend commitments shall be deemed adopted by the Council unless the Council decides, by means of an implementing act, to reject such a proposal by qualified majority within one month of the submission of the Commission proposal. The suspension of commitments shall apply to the commitments from 1 January of the year following the adoption of the decision to suspend. The Council shall adopt a decision, by means of an implementing act, on a proposal by the Commission referred to in paragraphs 1 and 2 in relation to the suspension of payments. 4. The scope and level of the suspension of commitments or payment to be imposed shall be proportionate, respect the equality of treatment between Member States and take into account the economic and social circumstances of the Member State concerned, in particular the level of unemployment, the level of poverty or social exclusion in the Member State concerned compared to the Union average and the impact of the suspension on the economy of the Member State concerned. 5. The suspension of commitments shall be subject to a maximum of 25 % of the commitments or 0,25 % of nominal GDP, whichever is lower, in any of the following cases: (a) in the first case of non-compliance with an excessive deficit procedure as referred to in paragraph 1; (b) in the first case of non-compliance relating to a corrective action plan under an excessive imbalance procedure as referred to in point (a) of paragraph 2; (c) in the case of non-compliance with the recommended corrective action pursuant to an excessive imbalance procedure as referred to in point (b) of paragraph 2; (d) in the first case of non-compliance as referred to in points (c) and (d) of paragraph 2. In the case of persistent non-compliance, the suspension of commitments may exceed the maximum percentages set out in the first subparagraph. 6. The Council shall lift the suspension of commitments on a proposal from the Commission, in accordance with the procedure set out in the first subparagraph of paragraph 3 of this Article, in the following cases: (a) where the excessive deficit procedure is held in abeyance in accordance with Article 9 of Regulation (EC) No 1467/97 or the Council has decided in accordance with Article 126(12) TFEU to abrogate the decision on the existence of an excessive deficit; (b) where the Council has endorsed the corrective action plan submitted by the Member State concerned in accordance with Article 8(2) of Regulation (EU) No 1176/2011 or the excessive imbalance procedure is placed in a position of abeyance in accordance with Article 10(5) of that Regulation or the Council has closed the excessive imbalance procedure in accordance with Article 11 of that Regulation; (c) where the Commission has concluded that a Member State has taken appropriate measures as referred to in Regulation (EC) No 332/2002; (d) where the Commission has concluded that the Member State concerned has taken appropriate measures to implement the macroeconomic adjustment programme referred to in Article 7 of Regulation (EU) No 472/2013 or the measures requested by a Council decision adopted in accordance with Article 136(1) TFEU. After the Council has lifted the suspension of commitments, the Commission may again enter into the commitments previously suspended without prejudice to Article 3(4), (7) and (9) of Regulation (EU) 2020/2094. A decision concerning the lifting of the suspension of payments shall be taken by the Council on a proposal by the Commission in accordance with the procedure set out in the third subparagraph of paragraph 3, where the applicable conditions set out in the first subparagraph of this paragraph are fulfilled. 7. The Commission shall keep the European Parliament informed of the implementation of this Article. In particular, when the Commission makes a proposal pursuant to paragraph 1 or 2, it shall immediately inform the European Parliament and provide details on commitments and payments which could be subject to a suspension. The competent committee of the European Parliament may invite the Commission to discuss the application of this Article in the context of a structured dialogue in order to allow the European Parliament to express its views. The Commission shall give due consideration to the views expressed by the European Parliament. The Commission shall transmit the proposal for suspension or the proposal to lift such a suspension, to the European Parliament and to the Council without delay after its adoption. The European Parliament may invite the Commission to explain the reasons for its proposal. 8. By 31 December 2024, the Commission shall carry out a review of the application of this Article. To that end, the Commission shall prepare a report which it shall transmit to the European Parliament and the Council, accompanied where necessary by a legislative proposal. 9. Where there are major changes in the social and economic situation in the Union, the Commission may submit a proposal to review the application of this Article, or the European Parliament or the Council, acting in accordance with Articles 225 or 241 TFEU respectively, may request the Commission to submit such a proposal. CHAPTER II FINANCIAL CONTRIBUTION, ALLOCATION PROCESS, LOANS AND REVIEW Article 11 Maximum financial contribution 1. The maximum financial contribution shall be calculated for each Member State as follows: (a) for 70 % of the amount referred to in point (a) of Article 6(1), converted into current prices, on the basis of the population, the inverse of the GDP per capita and the relative unemployment rate of each Member State as set out in the methodology in Annex II; (b) for 30 % of the amount referred to in point (a) of Article 6(1), converted into current prices, on the basis of the population, the inverse of the GDP per capita and, in equal proportion, the change in real GDP in 2020 and the aggregated change in real GDP for the period 2020-2021 as set out in the methodology in Annex III. The change in real GDP for 2020 and the aggregated change in real GDP for the period 2020-2021 shall be based on the Commission Autumn 2020 forecasts. 2. The calculation of the maximum financial contribution under point (b) of paragraph 1 shall be updated by 30 June 2022 for each Member State by replacing the data from the Commission Autumn 2020 forecasts with the actual outturns in relation to the change in real GDP 2020 and the aggregated change in real GDP for the period 2020-2021. Article 12 Allocation of financial contribution 1. Each Member State may submit a request up to its maximum financial contribution, referred to in Article 11, to implement its recovery and resilience plan. 2. Until 31 December 2022, the Commission shall make available for allocation 70 % of the amount referred to in point (a) of Article 6(1), converted into current prices. 3. From 1 January 2023 until 31 December 2023, the Commission shall make available for allocation 30 % of the amount referred to in point (a) of Article 6(1), converted into current prices. 4. The allocations under paragraphs 2 and 3 are without prejudice to Article 6(2). Article 13 Pre-financing 1. Subject to the adoption by 31 December 2021 by the Council of the implementing decision referred to in Article 20(1), and when requested by a Member State together with the submission of its recovery and resilience plan, the Commission shall make a pre-financing payment of an amount of up to 13 % of the financial contribution and, where applicable, of up to 13 % of the loan as set out in Article 20(2) and (3). By derogation from Article 116(1) of the Financial Regulation, the Commission shall make the corresponding payment within, to the extent possible, two months after the adoption by the Commission of the legal commitment referred to in Article 23. 2. In cases of pre-financing under paragraph 1 of this Article, the financial contributions and, where applicable, the loan to be paid as referred to in point (a) or point (h) of Article 20(5), respectively, shall be adjusted proportionally. 3. If the amount of pre-financing of the financial contribution under paragraph 1 of this Article exceeds 13 % of the maximum financial contribution calculated in accordance with Article 11(2) by 30 June 2022, the next payment authorised in accordance with Article 24(5), and if needed the following payments, shall be reduced until the excess amount is offset. If the remaining payments are insufficient, the excess amount shall be returned. Article 14 Loans 1. Until 31 December 2023, upon request from a Member State, the Commission may grant the Member State concerned a loan for the implementation of its recovery and resilience plan. 2. A Member State may request loan support at the time of the submission of a recovery and resilience plan referred to in Article 18, or at a different moment in time until 31 August 2023. In the latter case, the request shall be accompanied by a revised recovery and resilience plan, including additional milestones and targets. 3. The request for loan support by a Member State shall set out: (a) the reasons for the loan support, justified by the higher financial needs linked to additional reforms and investments; (b) the additional reforms and investments in line with Article 18; (c) the higher cost of the recovery and resilience plan concerned compared to the amount of the financial contributions allocated to the recovery and resilience plan respectively pursuant to point (a) or (b) of Article 20(4). 4. The loan support to the recovery and resilience plan of the Member State concerned shall not be higher than the difference between the total costs of the recovery and resilience plan, as revised where relevant, and the maximum financial contribution referred to in Article 11. 5. The maximum volume of the loan support for each Member State shall not exceed 6,8 % of its 2019 GNI in current prices. 6. By derogation from paragraph 5, subject to the availability of resources, in exceptional circumstances the amount of the loan support may be increased. 7. The loan shall be paid in instalments subject to the fulfilment of milestones and targets in line with Article 20(5)(h). 8. The Commission shall assess the request for loan support in accordance with Article 19. The Council shall adopt an implementing decision, on a proposal from the Commission, in accordance with Article 20(1). Where appropriate, the recovery and resilience plan shall be amended accordingly. Article 15 Loan agreement 1. Before entering into a loan agreement with the Member State concerned, the Commission shall assess whether: (a) the justification for requesting the loan support and its amount is considered reasonable and plausible in relation to the additional reforms and investments; and (b) the additional reforms and investments comply with the criteria set out in Article 19(3). 2. Where the Commission considers that the request for loan support fulfils the criteria of paragraph 1, and upon adoption of the Council implementing decision referred to in Article 20(1), the Commission shall enter into a loan agreement with the Member State concerned. The loan agreement, in addition to the elements laid down in Article 220(5) of the Financial Regulation, shall contain the following elements: (a) the amount of the loan in euro including, where applicable, the amount of the pre-financed loan in accordance with Article 13; (b) the average maturity; Article 220(2) of the Financial Regulation shall not apply with regard to this maturity; (c) the pricing formula and the availability period of the loan; (d) the maximum number of instalments and the repayment schedule; (e) the other elements needed for the implementation of the loan in relation to the reforms and the investment projects concerned in line with the decision referred to in Article 20(3). 3. In accordance with point (e) of Article 220(5) of the Financial Regulation, costs related to the borrowing of funds for the loans referred to in this Article shall be borne by the beneficiary Member States. 4. The Commission shall establish the necessary arrangements for the administration of the lending operations related to loans granted in accordance with this Article. 5. A Member State benefitting from a loan granted in accordance with this Article shall open a dedicated account for the management of the loan received. It shall also transfer the principal and the interest due on any related loan to an account indicated by the Commission in line with the arrangements put in place in accordance with paragraph 4 twenty business days before the corresponding due date. Article 16 Review report 1. By 31 July 2022, the Commission shall present to the European Parliament and the Council a review report on the implementation of the Facility. 2. The review report shall set out the following elements: (a) an assessment of the extent to which the implementation of the recovery and resilience plans is in line with the scope and contributes to the general objective of this Regulation in line with the six pillars referred to in Article 3, including how the recovery and resilience plans tackle the inequalities between women and men; (b) a quantitative assessment of the contribution of the recovery and resilience plans to: (i) the climate target of at least 37 %, (ii) the digital target of at least 20 %, (iii) each of the six pillars referred to in Article 3; (c) the state of the implementation of the recovery and resilience plans and observations and guidance to the Member States before the update of their recovery and resilience plans referred to in Article 18(2). 3. For the purposes of the review report referred to in paragraph 1 of this Article, the Commission shall take into account the scoreboard referred to in Article 30, the reports of the Member States referred to in Article 27 and any other relevant information on the fulfilment of the milestones and targets of the recovery and resilience plans as available from the payment, suspension and termination procedures referred to in Article 24. 4. The competent committee of the European Parliament may invite the Commission to present the main findings of the review report in the context of the recovery and resilience dialogue referred to in Article 26. CHAPTER III RECOVERY AND RESILIENCE PLANS Article 17 Eligibility 1. Within the scope set out in Article 3 and in pursuit of the objectives set out in Article 4, Member States shall prepare national recovery and resilience plans. Those plans shall set out the reform and investment agenda of the Member State concerned. Recovery and resilience plans that are eligible for financing under the Facility shall comprise measures for the implementation of reforms and public investment through a comprehensive and coherent package, which may also include public schemes that aim to incentivise private investment. 2. Measures started from 1 February 2020 onwards shall be eligible provided that they comply with the requirements set out in this Regulation. 3. The recovery and resilience plans shall be consistent with the relevant country-specific challenges and priorities identified in the context of the European Semester, as well as those identified in the most recent Council recommendation on the economic policy of the euro area for Member States whose currency is the euro. The recovery and resilience plans shall also be consistent with the information included by the Member States in the National Reform Programmes under the European Semester, in their National Energy and Climate Plans and updates thereof under Regulation (EU) 2018/1999, in the territorial just transition plans under a Regulation of the European Parliament and of the Council establishing the Just Transition Fund (the \u2018Just Transition Fund Regulation\u2019), in the Youth Guarantee implementation plans and in the partnership agreements and operational programmes under the Union funds. 4. The recovery and resilience plans shall respect the horizontal principles set out in Article 5. 5. Where a Member State is exempt from the monitoring and assessment in the context of the European Semester on the basis of Article 12 of Regulation (EU) No 472/2013, or is subject to surveillance under Regulation (EC) No 332/2002, this Regulation shall apply to the Member State concerned in relation to the challenges and priorities identified by the measures set out in those Regulations. Article 18 Recovery and resilience plan 1. A Member State wishing to receive a financial contribution in accordance with Article 12 shall submit to the Commission a recovery and resilience plan as defined in Article 17(1). 2. After the Commission makes available for allocation the amount referred to in Article 12(3), a Member State may update and submit the recovery and resilience plan referred to in paragraph 1 of this Article to take into account the updated maximum financial contribution calculated in accordance with Article 11(2). 3. The recovery and resilience plan presented by the Member State may be submitted in a single integrated document together with the National Reform Programme and shall be officially submitted, as a rule, by 30 April. A draft recovery and resilience plan may be submitted by Member States from 15 October of the preceding year. 4. The recovery and resilience plan shall be duly reasoned and substantiated. It shall in particular set out the following elements: (a) an explanation of how the recovery and resilience plan, taking into account the measures included therein, represents a comprehensive and adequately balanced response to the economic and social situation of the Member State, thereby contributing appropriately to all pillars referred to in Article 3, taking into account the specific challenges of the Member State concerned; (b) an explanation of how the recovery and resilience plan contributes to effectively address all or a significant subset of challenges identified in the relevant country-specific recommendations, including fiscal aspects thereof and recommendations made pursuant to Article 6 of Regulation (EU) No 1176/2011 where appropriate, addressed to the Member State concerned, or challenges identified in other relevant documents officially adopted by the Commission in the context of the European Semester; (c) a detailed explanation of how the recovery and resilience plan strengthens the growth potential, job creation and economic, social and institutional resilience of the Member State concerned, including through the promotion of policies for children and the youth, and mitigates the economic and social impact of the COVID-19 crisis, contributing to the implementation of the European Pillar of Social Rights, and thereby enhancing the economic, social and territorial cohesion and convergence within the Union; (d) an explanation of how the recovery and resilience plan ensures that no measure for the implementation of reforms and investments included in the recovery and resilience plan does significant harm to environmental objectives within the meaning of Article 17 of Regulation (EU) 2020/852 (the principle of \u2018do no significant harm\u2019); (e) a qualitative explanation of how the measures in the recovery and resilience plan are expected to contribute to the green transition, including biodiversity, or to addressing the challenges resulting therefrom, and whether they account for an amount that represents at least 37 % of the recovery and resilience plan\u2019s total allocation, based on the methodology for climate tracking set out in Annex VI; that methodology shall be used accordingly for measures that cannot be directly assigned to an intervention field listed in Annex VI; the coefficients for support for the climate objectives may be increased up to a total amount of 3 % of the allocation of the recovery and resilience plan for individual investments to take account of accompanying reform measures that credibly increase their impact on the climate objectives as explained in the recovery and resilience plan; (f) an explanation of how the measures in the recovery and resilience plan are expected to contribute to the digital transition or to the challenges resulting therefrom, and whether they account for an amount which represents at least 20 % of the recovery and resilience plan\u2019s total allocation, based on the methodology for digital tagging set out in Annex VII; that methodology shall be used accordingly for measures that cannot be directly assigned to an intervention field listed in Annex VII; the coefficients for support for the digital objectives may be increased for individual investments to take account of accompanying reform measures that increase their impact on the digital objectives; (g) where appropriate, for investments in digital capacities and connectivity, a security self-assessment based on common objective criteria identifying any security issues, and detailing how those issues will be addressed in order to comply with relevant Union and national law; (h) an indication of whether the measures included in the recovery and resilience plan comprise cross-border or multi-country projects; (i) envisaged milestones, targets and an indicative timetable for the implementation of the reforms, and investments to be completed by 31 August 2026; (j) the envisaged investment projects and the related investment period; (k) the estimated total costs of the reforms and investments covered by the recovery and resilience plan submitted (also referred to as \u2018estimated total costs of the recovery and resilience plan\u2019) backed up by appropriate justification and by explanations of how it is in line with the principle of cost efficiency and commensurate to the expected national economic and social impact; (l) where relevant, information on existing or planned Union financing; (m) the accompanying measures that may be needed; (n) a justification of the coherence of the recovery and resilience plan; and an explanation of its consistency with the principles, plans and programmes referred to in Article 17; (o) an explanation of how the measures in the recovery and resilience plan are expected to contribute to gender equality and equal opportunities for all and the mainstreaming of those objectives, in line with principles 2 and 3 of the European Pillar of Social Rights, with the UN Sustainable Development Goal 5 and, where relevant, with the national gender equality strategy; (p) the arrangements for the effective monitoring and implementation of the recovery and resilience plan by the Member State concerned, including the proposed milestones and targets, and the related indicators; (q) for the preparation and, where available, for the implementation of the recovery and resilience plan, a summary of the consultation process, conducted in accordance with the national legal framework, of local and regional authorities, social partners, civil society organisations, youth organisations and other relevant stakeholders, and how the input of the stakeholders is reflected in the recovery and resilience plan; (r) an explanation of the Member State\u2019s system to prevent, detect and correct corruption, fraud and conflicts of interests, when using the funds provided under the Facility, and the arrangements that aim to avoid double funding from the Facility and other Union programmes; (s) where appropriate, the request for loan support and the additional milestones as referred to in Article 14(2) and (3) and the elements thereof; and (t) any other relevant information. 5. When preparing their recovery and resilience plans, Member States may request the Commission to organise an exchange of good practices in order to allow the requesting Member States to benefit from the experience of other Member States. Member States may also request technical support under the Technical Support Instrument. Member States shall be encouraged to foster synergies with recovery and resilience plans of other Member States. Article 19 Commission assessment 1. The Commission shall assess the recovery and resilience plan or, where applicable, the update to that plan submitted by the Member State in accordance with Article 18(1) or 18(2) within two months of the official submission, and make a proposal for a Council implementing decision in accordance with Article 20(1). When carrying out that assessment, the Commission shall act in close cooperation with the Member State concerned. The Commission may make observations or seek additional information. The Member State concerned shall provide the requested additional information and may revise the recovery and resilience plan if needed, including after the official submission of the recovery and resilience plan. The Member State concerned and the Commission may agree to extend the deadline for assessment by a reasonable period if necessary. 2. When assessing the recovery and resilience plan and in the determination of the amount to be allocated to the Member State concerned, the Commission shall take into account the analytical information on the Member State concerned available in the context of the European Semester as well as the justification and the elements provided by that Member State, as referred to in Article 18(4), as well as any other relevant information such as, in particular, the information contained in the National Reform Programme and the National Energy and Climate Plan of that Member State, in the territorial just transition plans under the Just Transition Fund Regulation, in the Youth Guarantee implementation plans and, if relevant, information from technical support received via the Technical Support Instrument. 3. The Commission shall assess the relevance, effectiveness, efficiency and coherence of the recovery and resilience plan and, for that purpose, shall take into account the following criteria which it shall apply in accordance with Annex V: Relevance: (a) whether the recovery and resilience plan represents a comprehensive and adequately balanced response to the economic and social situation, thereby contributing appropriately to all six pillars referred to in Article 3, taking the specific challenges and the financial allocation of the Member State concerned into account; (b) whether the recovery and resilience plan is expected to contribute to effectively addressing all or a significant subset of challenges identified in the relevant country-specific recommendations, including fiscal aspects thereof and recommendations made pursuant to Article 6 of Regulation (EU) No 1176/2011 where appropriate, addressed to the Member State concerned or challenges identified in other relevant documents officially adopted by the Commission in the context of the European Semester; (c) whether the recovery and resilience plan is expected to effectively contribute to strengthening the growth potential, job creation, and economic, social and institutional resilience of the Member State, contributing to the implementation of the European Pillar of Social Rights, including through the promotion of policies for children and the youth, and to mitigating the economic and social impact of the COVID-19 crisis, thereby enhancing the economic, social and territorial cohesion and convergence within the Union; (d) whether the recovery and resilience plan is expected to ensure that no measure for the implementation of reforms and investment projects included in the recovery and resilience plan does significant harm to environmental objectives within the meaning of Article 17 of Regulation (EU) 2020/852 (the principle of \u2018do no significant harm\u2019); the Commission shall provide technical guidance to the Member States to that effect; (e) whether the recovery and resilience plan contains measures that effectively contribute to the green transition, including biodiversity, or to addressing the challenges resulting therefrom, and whether they account for an amount which represents at least 37 % of the recovery and resilience plan\u2019s total allocation, based on the methodology for climate tracking set out in Annex VI; that methodology shall be used accordingly for measures that cannot be directly assigned to an intervention field listed in Annex VI; the coefficients for support for the climate objectives may be increased up to a total amount of 3 % of the allocation of the recovery and resilience plan for individual investments to take account of accompanying reform measures that credibly increase their impact on the climate objectives, subject to the agreement of the Commission; (f) whether the recovery and resilience plan contains measures that effectively contribute to the digital transition or to addressing the challenges resulting therefrom, and whether they account for an amount which represents at least 20 % of the recovery and resilience plan\u2019s total allocation, based on the methodology for digital tagging set out in Annex VII; that methodology shall be used accordingly for measures that cannot be directly assigned to an intervention field listed in Annex VII; the coefficients for support for the digital objectives may be increased for individual investments to take account of accompanying reform measures that increase their impact on the digital objectives; Effectiveness: (g) whether the recovery and resilience plan is expected to have a lasting impact on the Member State concerned; (h) whether the arrangements proposed by the Member States concerned are expected to ensure an effective monitoring and implementation of the recovery and resilience plan, including the envisaged timetable, milestones and targets, and the related indicators; Efficiency: (i) whether the justification provided by the Member State on the amount of the estimated total costs of the recovery and resilience plan is reasonable and plausible and is in line with the principle of cost efficiency and is commensurate to the expected national economic and social impact; (j) whether the arrangements proposed by the Member State concerned are expected to prevent, detect and correct corruption, fraud and conflicts of interests when using the funds provided under the Facility, including the arrangements that aim to avoid double funding from the Facility and other Union programmes; Coherence: (k) whether the recovery and resilience plan contains measures for the implementation of reforms and public investment projects that represent coherent actions. 4. Where the Member State concerned has requested a loan as referred to in Article 14, the Commission shall assess whether the request for a loan fulfils the criteria set out in Article 15(1), and in particular whether the additional reforms and investments in respect of which that request was made, fulfil the assessment criteria of paragraph 3. 5. Where the Commission gives a negative assessment to a recovery and resilience plan, it shall communicate a duly justified assessment within the deadline set out in paragraph 1. 6. For the purpose of the assessment of the recovery and resilience plans submitted by Member States, the Commission may be assisted by experts. Article 20 Commission proposal and Council implementing decision 1. On a proposal from the Commission, the Council shall approve by means of an implementing decision the assessment of the recovery and resilience plan submitted by the Member State in accordance with Article 18(1) or, where applicable, of its update submitted in accordance with Article 18(2). 2. In the event that the Commission gives a positive assessment to a recovery and resilience plan, the Commission proposal for a Council implementing decision shall set out the reforms and investment projects to be implemented by the Member State, including the milestones and targets, and the financial contributions calculated in accordance with Article 11. 3. Where the Member State concerned requests loan support, the Commission proposal for a Council implementing decision shall also set out the amount of the loan support as referred to in Article 14(4) and (6) and the additional reforms and investment projects to be implemented by the Member State covered by that loan, including the additional milestones and targets. 4. The financial contribution referred to in paragraph 2 shall be determined on the basis of the estimated total costs of the recovery and resilience plan proposed by the Member State concerned, as assessed under the criteria set out in Article 19(3). The amount of financial contribution shall be set as follows: (a) where the recovery and resilience plan complies satisfactorily with the criteria set out in Article 19(3), and the amount of the estimated total costs of the recovery and resilience plan is equal to, or higher than, the maximum financial contribution calculated for that Member State in accordance with Article 11, the financial contribution allocated to the Member State concerned shall be equal to the total amount of the maximum financial contribution calculated for that Member State in accordance with Article 11; (b) where the recovery and resilience plan complies satisfactorily with the criteria set out in Article 19(3), and the amount of the estimated total costs of the recovery and resilience plan is lower than the maximum financial contribution calculated for that Member State in accordance with Article 11, the financial contribution allocated to the Member State shall be equal to the amount of the estimated total costs of the recovery and resilience plan; (c) where the recovery and resilience plan does not comply satisfactorily with the criteria set out in Article 19(3), no financial contribution shall be allocated to the Member State concerned. 5. The Commission proposal referred to in paragraph 2 shall also lay down: (a) the financial contribution to be paid in instalments once the Member State has satisfactorily fulfilled the relevant milestones and targets identified in relation to the implementation of the recovery and resilience plan; (b) the financial contribution and, where applicable, the amount of the loan support to be paid in the form of a pre-financing in accordance with Article 13 after the approval of the recovery and resilience plan; (c) the description of the reforms and of the investment projects and the amount of the estimated total costs of the recovery and resilience plan; (d) the time limit, which should be no later than 31 August 2026, by which the final milestones and targets for both investment projects and reforms must be completed; (e) the arrangements and timetable for monitoring and implementation of the recovery and resilience plan including, where relevant, measures necessary for complying with Article 22; (f) the relevant indicators relating to the fulfilment of the envisaged milestones and targets; (g) the arrangements for providing full access by the Commission to the underlying relevant data; and (h) where appropriate, the amount of the loan to be paid in instalments and the additional milestones and targets related to the payment of the loan. 6. The arrangements and timetable for monitoring and implementation as referred to in point (e) of paragraph 5, the relevant indicators relating to the fulfilment of the envisaged milestones and targets referred to in point (f) of paragraph 5, the arrangements for providing full access by the Commission to the underlying data referred to in point (g) of paragraph 5, and, where appropriate, the additional milestones and targets related to the payment of the loan referred to in point (h) of paragraph 5 shall be further specified in operational arrangements to be agreed by the Member State concerned and the Commission after the adoption of the decision referred to in paragraph 1. 7. The Council shall adopt the implementing decisions referred to in paragraph 1, as a rule, within four weeks of the adoption of the Commission proposal. 8. The Council, on a proposal from the Commission, shall amend its implementing decision adopted in accordance with Article 20(1) to include the updated maximum financial contribution, calculated in accordance with Article 11(2), without undue delay. Article 21 Amendment of the Member State\u2019s recovery and resilience plan 1. Where the recovery and resilience plan including relevant milestones and targets is no longer achievable, either partially or totally, by the Member State concerned because of objective circumstances, the Member State concerned may make a reasoned request to the Commission to make a proposal to amend or replace the Council implementing decisions referred to in Article 20(1) and (3). To that end, the Member State may propose an amended or a new recovery and resilience plan. Member States may request technical support for the preparation of such proposal under the Technical Support Instrument. 2. Where the Commission considers that the reasons put forward by the Member State concerned justify an amendment of the relevant recovery and resilience plan, the Commission shall assess the amended or new recovery and resilience plan in accordance with Article 19 and shall make a proposal for a new Council implementing decision in accordance with Article 20(1) within two months of the official submission of the request. The Member State concerned and the Commission may agree to extend that deadline by a reasonable period if necessary. The Council shall adopt the new implementing decision, as a rule, within four weeks of the adoption of the Commission proposal. 3. Where the Commission considers that the reasons put forward by the Member State concerned do not justify an amendment of the relevant recovery and resilience plan, it shall reject the request within the period referred to in paragraph 2, after having given the Member State concerned the possibility to present its observations within one month of the communication of the Commission\u2019s conclusions. CHAPTER IV FINANCIAL PROVISIONS Article 22 Protection of the financial interests of the Union 1. In implementing the Facility, the Member States, as beneficiaries or borrowers of funds under the Facility, shall take all the appropriate measures to protect the financial interests of the Union and to ensure that the use of funds in relation to measures supported by the Facility complies with the applicable Union and national law, in particular regarding the prevention, detection and correction of fraud, corruption and conflicts of interests. To this effect, the Member States shall provide an effective and efficient internal control system and the recovery of amounts wrongly paid or incorrectly used. Member States may rely on their regular national budget management systems. 2. The agreements referred to in Articles 15(2) and 23(1) shall provide for the obligations of the Member States: (a) to regularly check that the financing provided has been properly used in accordance with all applicable rules and that any measure for the implementation of reforms and investment projects under the recovery and resilience plan has been properly implemented in accordance with all applicable rules in particular regarding the prevention, detection and correction of fraud, corruption and conflicts of interests; (b) to take appropriate measures to prevent, detect and correct fraud, corruption, and conflicts of interests as defined in Article 61(2) and (3) of the Financial Regulation affecting the financial interests of the Union and to take legal actions to recover funds that have been misappropriated, including in relation to any measure for the implementation of reforms and investment projects under the recovery and resilience plan; (c) to accompany a request for payment by: (i) a management declaration that the funds were used for its intended purpose, that the information submitted with the request for payment is complete, accurate and reliable and that the control systems put in place give the necessary assurances that the funds were managed in accordance with all applicable rules, in particular rules on avoidance of conflicts of interests, fraud prevention, corruption and double funding from the Facility and other Union programmes in accordance with the principle of sound financial management; and (ii) a summary of the audits carried out, including weaknesses identified and any corrective actions taken; (d) for the purpose of audit and control and to provide for comparable information on the use of funds in relation to measures for the implementation of reforms and investment projects under the recovery and resilience plan, to collect and ensure access to the following standardised categories of data: (i) name of the final recipient of funds; (ii) name of the contractor and sub-contractor, where the final recipient of funds is a contracting authority in accordance with Union or national law on public procurement; (iii) first name(s), last name(s) and date of birth of beneficial owner(s) of the recipient of funds or contractor, as defined in point 6 of Article 3 of Directive (EU) 2015/849 of the European Parliament and of the Council (26); (iv) a list of any measures for the implementation of reforms and investment projects under the recovery and resilience plan with the total amount of public funding of those measures and indicating the amount of funds paid under the Facility and under other Union funds; (e) to expressly authorise the Commission, OLAF, the Court of Auditors and, where applicable, EPPO to exert their rights as provided for in Article 129(1) of the Financial Regulation and to impose obligations on all final recipients of funds paid for the measures for the implementation of reforms and investment projects included in the recovery and resilience plan, or to all other persons or entities involved in their implementation to expressly authorise the Commission, OLAF, the Court of Auditors and, where applicable, EPPO to exert their rights as provided for in Article 129(1) of the Financial Regulation and to impose similar obligations on all final recipients of funds disbursed; (f) to keep records in accordance with Article 132 of the Financial Regulation. 3. Personal data as referred to in point (d) of paragraph 2 of this Article shall only be processed by Member States and by the Commission for the purpose, and corresponding duration, of discharge, audit and control proceedings related to the use of funds related to the implementation of the agreements referred to in Articles 15(2) and 23(1). Within the framework of the discharge procedure to the Commission, in accordance with Article 319 TFEU, the Facility shall be subject to reporting under the integrated financial and accountability reporting referred to in Article 247 of the Financial Regulation, and, in particular, separately in the Annual Management and Performance Report. 4. The Commission shall make available to the Member States an integrated and interoperable information and monitoring system including a single data-mining and risk-scoring tool to access and analyse the relevant data, with a view to a generalised application by Member States of that system including with support of the Technical Support Instrument. 5. The agreements referred to in Articles 15(2) and 23(1) shall also provide for the right of the Commission to reduce proportionately the support under the Facility and recover any amount due to the Union budget or to ask for early repayment of the loan, in cases of fraud, corruption, and conflicts of interests affecting the financial interests of the Union that have not been corrected by the Member State, or a serious breach of an obligation resulting from such agreements. When deciding on the amount of the recovery and reduction, or the amount to be repaid early, the Commission shall respect the principle of proportionality and shall take into account the seriousness of the fraud, corruption and conflict of interests affecting the financial interests of the Union, or of a breach of an obligation. The Member State shall be given the opportunity to present its observations before the reduction is made or early repayment is requested. Article 23 Commitment of the financial contribution 1. Once the Council has adopted an implementing decision as referred to in Article 20(1), the Commission shall conclude an agreement with the Member State concerned constituting an individual legal commitment within the meaning of the Financial Regulation. For each Member State the legal commitment shall not exceed the financial contribution referred to in point (a) of Article 11(1) for 2021 and 2022, and the updated financial contribution referred to in Article 11(2) for 2023. 2. Budgetary commitments may be based on global commitments and, where appropriate, may be broken down into annual instalments spread over several years. Article 24 Rules on payments, suspension and termination of agreements regarding financial contributions and loans 1. Payments of financial contributions and, where applicable, of the loan to the Member State concerned under this Article shall be made by 31 December 2026 and in accordance with the budget appropriations and subject to the available funding. 2. Upon completion of the relevant agreed milestones and targets indicated in the recovery and resilience plan as approved in accordance with Article 20, the Member State concerned shall submit to the Commission a duly justified request for payment of the financial contribution and, where relevant, of the loan. Such requests for payment may be submitted by the Member States to the Commission twice a year. 3. The Commission shall assess on a preliminary basis without undue delay, and at the latest within two months of receiving the request, whether the relevant milestones and targets set out in the Council implementing decision referred to in Article 20(1) have been satisfactorily fulfilled. The satisfactory fulfilment of milestones and targets shall presuppose that measures related to previously satisfactorily fulfilled milestones and targets have not been reversed by the Member State concerned. For the purpose of the assessment, the operational arrangements referred to in Article 20(6) shall also be taken into account. The Commission may be assisted by experts. 4. Where the Commission makes a positive preliminary assessment of the satisfactory fulfilment of the relevant milestones and targets, it shall provide its findings to the Economic and Financial Committee and ask for its opinion on the satisfactory fulfilment of the relevant milestones and targets. The Commission shall take the opinion of the Economic and Financial Committee into account for its assessment. 5. Where the Commission makes a positive assessment, it shall adopt without undue delay a decision authorising the disbursement of the financial contribution and, where applicable, of the loan in accordance with the Financial Regulation. Such decision shall be adopted in accordance with the examination procedure referred to in Article 35(2). 6. Where, as a result of the assessment referred to in paragraph 5, the Commission establishes that the milestones and targets set out in the Council implementing decision referred to in Article 20(1) have not been satisfactorily fulfilled, the payment of all or part of the financial contribution and, where applicable, of the loan shall be suspended. The Member State concerned may present its observations within one month of the communication of the Commission\u2019s assessment. The suspension shall only be lifted where the Member State concerned has taken the necessary measures to ensure a satisfactory fulfilment of the milestones and targets set out in the Council implementing decision referred to in Article 20(1). 7. By derogation from Article 116(2) of the Financial Regulation, the payment deadline shall start running from the date of the communication of the decision authorising the disbursement to the Member State concerned pursuant to paragraph 5 of this Article, or from the date of the communication of the lifting of a suspension pursuant to the second subparagraph of paragraph 6 of this Article. 8. Where the Member State concerned has not taken the necessary measures within a period of six months from the suspension, the Commission shall reduce the amount of the financial contribution and, where applicable, of the loan proportionately after having given the Member State concerned the possibility to present its observations within two months from the communication of its conclusions. 9. Where, within 18 months of the date of the adoption of the Council implementing decision referred to in Article 20(1), no tangible progress has been made in respect of any relevant milestones and targets by the Member State concerned, the Commission shall terminate the agreements referred to in Articles 15(2) and 23(1) and shall decommit the amount of the financial contribution without prejudice to Article 14(3) of the Financial Regulation. Any pre-financing in accordance with Article 13 shall be recovered in full. The Commission shall take a decision on the termination of agreements referred to in Articles 15(2) and 23(1) and, where applicable, of the recovery of the pre-financing after having given the Member State concerned the possibility to present its observations within a period of two months of the communication of its assessment as to whether no tangible progress has been made. 10. If exceptional circumstances arise, the adoption of the decision authorising the disbursement of the financial contribution and, where applicable, of the loan in accordance with paragraph 5 may be postponed for up to three months. CHAPTER V INSTITUTIONAL PROVISIONS Article 25 Transparency 1. The Commission shall transmit the recovery and resilience plans officially submitted by the Member States, and the proposals for Council implementing decisions referred to in Article 20(1), as made public by the Commission, simultaneously and on equal terms to the European Parliament and the Council without undue delay. 2. Information transmitted by the Commission to the Council or any of its preparatory bodies in the context of this Regulation or its implementation shall simultaneously be made available to the European Parliament, subject to confidentiality arrangements if necessary. Relevant outcomes of discussions held in Council preparatory bodies shall be shared with the competent committee of the European Parliament. 3. The Member State concerned may request the Commission to redact sensitive or confidential information, the disclosure of which would jeopardise public interests of the Member State. In such a case, the Commission shall liaise with the European Parliament and the Council regarding how the redacted information can be made available to them in a confidential manner in accordance with the applicable rules. 4. The Commission shall provide the competent committee of the European Parliament with an overview of its preliminary findings concerning the satisfactory fulfilment of the relevant milestones and targets included in the recovery and resilience plans of the Member States. 5. The competent committee of the European Parliament may invite the Commission to provide information on the state of play of the assessment of the recovery and resilience plans in the context of the recovery and resilience dialogue referred to in Article 26. Article 26 Recovery and resilience dialogue 1. In order to enhance the dialogue between the Union institutions, in particular the European Parliament, the Council and the Commission, and to ensure greater transparency and accountability, the competent committee of the European Parliament may invite the Commission every two months to discuss the following matters: (a) the state of recovery, resilience and adjustment capacity in the Union, as well as the measures adopted under this Regulation; (b) the recovery and resilience plans of the Member States; (c) the assessment of the recovery and resilience plans of the Member States; (d) the main findings of the review report referred to in Article 16(2); (e) the status of fulfilment of the milestones and targets of the recovery and resilience plans of the Member States; (f) payment, suspension and termination procedures, including any observation presented and remedial measures taken by the Member States to ensure a satisfactory fulfilment of the milestones and targets; (g) any other relevant information and documentation provided by the Commission to the competent committee of the European Parliament in relation to the implementation of the Facility. 2. The European Parliament may express its views in resolutions as regards the matters referred to in paragraph 1. 3. The Commission shall take into account any elements arising from the views expressed through the recovery and resilience dialogue, including the resolutions from the European Parliament if provided. 4. The recovery and resilience scoreboard referred to in Article 30 shall serve as a basis for the recovery and resilience dialogue. CHAPTER VI REPORTING Article 27 Reporting by the Member State in the context of the European Semester The Member State concerned shall report twice a year in the context of the European Semester on the progress made in the achievement of its recovery and resilience plan, including the operational arrangements referred to in Article 20(6) and on the common indicators as referred to in Article 29(4). To that end, the reports of the Member States shall be appropriately reflected in the National Reform Programmes, which shall be used as a tool for reporting on the progress towards completion of the recovery and resilience plans. CHAPTER VII COMPLEMENTARITY, MONITORING AND EVALUATION Article 28 Coordination and complementarity The Commission and the Member States concerned shall, in a manner commensurate to their respective responsibilities, foster synergies and ensure effective coordination between the Facility and other Union programmes and instruments, including the Technical Support Instrument, and in particular with measures financed by the Union funds. For that purpose, they shall: (a) ensure complementarity, synergy, coherence and consistency among different instruments at Union, national and, where appropriate, regional levels, in particular in relation to measures financed by Union funds, both in the planning phase and during implementation; (b) optimise mechanisms for coordination to avoid duplication of effort; and (c) ensure close cooperation between those responsible for implementation and control at Union, national and, where appropriate, regional levels to achieve the objectives of the Facility. Article 29 Monitoring of implementation 1. The Commission shall monitor the implementation of the Facility and measure the achievement of the objectives set out in Article 4. The monitoring of implementation shall be targeted and proportionate to the activities carried out under the Facility. 2. The performance reporting system of the Commission shall ensure that data for monitoring the implementation of the activities and results are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funding. 3. The Commission shall report ex-post on the expenditure financed by the Facility under each of the pillars referred to in Article 3. Such reporting will be based on the break-down of the estimated expenditure provided in the approved recovery and resilience plans. 4. The Commission shall be empowered to adopt, by the end of December 2021, delegated acts in accordance with Article 33 to supplement this Regulation in order to: (a) set out the common indicators to be used for reporting on the progress and for the purpose of monitoring and evaluation of the Facility towards the achievement of the general and specific objectives; and (b) define a methodology for reporting social expenditure, including on children and the youth, under the Facility. 5. Member States shall report to the Commission on the common indicators. Article 30 Recovery and resilience scoreboard 1. The Commission shall establish a recovery and resilience scoreboard (the \u2018Scoreboard\u2019), which shall display the progress of the implementation of the recovery and resilience plans of the Member States in each of the six pillars referred to in Article 3. The Scoreboard shall constitute the performance reporting system of the Facility. 2. The Commission shall be empowered to adopt a delegated act in accordance with Article 33 to supplement this Regulation by defining the detailed elements of the Scoreboard with a view to displaying the progress of the implementation of the recovery and resilience plans as referred to in paragraph 1. 3. The Scoreboard shall also display the progress of the implementation of the recovery and resilience plans in relation to the common indicators referred to in Article 29(4). 4. The Scoreboard shall be operational by December 2021 and shall be updated by the Commission twice a year. The Scoreboard shall be made publicly available on a website or internet portal. Article 31 Annual report 1. The Commission shall provide an annual report to the European Parliament and the Council on the implementation of the Facility. 2. The annual report shall include information on the progress made with the recovery and resilience plans of the Member States concerned under the Facility, including information on the status of the implementation of the milestones and targets, and the status of payments and suspensions thereof. 3. The annual report shall also include the following information on: (a) the contribution of the Facility to the climate and digital targets; (b) the performance of the Facility based on the common indicators referred to in Article 29(4); (c) the expenditure financed by the Facility under the six pillars referred to in Article 3, incorporating social expenditure, including on children and the youth, as referred to in Article 29(4). 4. For the purpose of reporting on the activities referred to in paragraphs 2 and 3, the Commission may use the content of the relevant documents officially adopted by the Commission under the European Semester, as appropriate. Article 32 Evaluation and ex post evaluation of the Facility 1. By 20 February 2024, the Commission shall provide the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions with an independent evaluation report on the implementation of the Facility, and by 31 December 2028 with an independent ex post evaluation report. 2. The evaluation report shall, in particular, assess to which extent the objectives have been achieved, the efficiency of the use of the resources and the European added value. It shall also consider the continued relevance of all objectives and actions. 3. Where appropriate, the evaluation shall be accompanied by a proposal for amendments to this Regulation. 4. The ex post evaluation report shall consist of a global assessment of the Facility and shall include information on its impact in the long term. Article 33 Exercise of delegation 1. The power to adopt delegated acts shall be conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 29(4) and 30(2) shall be conferred on the Commission for an indeterminate period of time from 19 February 2021. 3. The delegations of power referred to in Articles 29(4) and 30(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 29(4) and 30(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of one month of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by one month at the initiative of the European Parliament or of the Council. CHAPTER VIII COMMUNICATION AND FINAL PROVISIONS Article 34 Information, communication and publicity 1. The Commission may engage in communication activities to ensure the visibility of the Union funding for the financial support envisaged in the relevant recovery and resilience plan, including through joint communication activities with the national authorities concerned. The Commission may, as appropriate, ensure that support under the Facility is communicated and acknowledged through a funding statement. 2. The recipients of Union funding shall acknowledge the origin and ensure the visibility of the Union funding, including, where applicable, by displaying the emblem of the Union and an appropriate funding statement that reads \u2018funded by the European Union \u2013 NextGenerationEU\u2019, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 3. The Commission shall implement information and communication actions relating to the Facility, to actions taken pursuant to the Facility and to the results obtained. The Commission shall where appropriate inform the representation offices of the European Parliament of its actions and involve them in those actions. Financial resources allocated to the Facility shall also contribute to the corporate communication of the political priorities of the Union, insofar as they are related to the objectives referred to in Article 4. Article 35 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 36 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 12 February 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. COSTA (1) OJ C 364, 28.10.2020, p. 132. (2) OJ C 440, 18.12.2020, p. 160. (3) Position of the European Parliament of 10 February 2021 (not yet published in the Official Journal) and decision of the Council of 11 February 2021. (4) OJ L 282, 19.10.2016, p. 4. (5) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1). (6) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (7) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433 I, 22.12.2020, p. 23). (8) Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (See page 1 of this Official Journal). (9) Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13). (10) Regulation (EU) No 472/2013 of the European Parliament and of the Council of 21 May 2013 on the strengthening of economic and budgetary surveillance of Member States in the euro area experiencing or threatened with serious difficulties with respect to their financial stability (OJ L 140, 27.5.2013, p. 1). (11) Council Regulation (EC) No 332/2002 of 18 February 2002 establishing a facility providing medium-term financial assistance for Member States\u2019 balances of payments (OJ L 53, 23.2.2002, p. 1). (12) Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances (OJ L 306, 23.11.2011, p. 25). (13) Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, p. 1). (14) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (15) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (16) OJ L 123, 12.5.2016, p. 1. (17) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (18) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (19) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (20) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (21) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (22) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (23) Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (OJ L 209, 2.8.1997, p. 1). (24) Regulation (EU, Euratom) 2020/2092 of the European Parliament and of the Council of 16 December 2020 on a general regime of conditionality for the protection of the Union budget (OJ L 433I, 22.12.2020, p. 1). (25) Council Regulation (EC) No 1467/97 of 7 July 1997 on speeding up and clarifying the implementation of the excessive deficit procedure (OJ L 209, 2.8.1997, p. 6). (26) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73). ANNEX I Methodology for the calculation of the maximum financial contribution per Member State under the Facility This Annex sets out the methodology for calculating the maximum financial contribution available for each Member State in accordance with Article 11. The method takes into account, with regard to each Member State: \u2014 the population; \u2014 the inverse of the GDP per capita; \u2014 the average unemployment rate over the past five years compared to the Union average (2015-2019); \u2014 the fall in real GDP in 2020 and the fall in real GDP in 2020 and 2021 combined. To avoid excessive concentration of resources: \u2014 the inverse of the GDP per capita is capped at a maximum of 150 % of the Union average; \u2014 the deviation of an individual Member State\u2019s unemployment rate from the Union average is capped at a maximum of 150 % of the Union average; \u2014 to account for the generally more stable labour markets of wealthier Member States (with GNI per capita above the Union average) the deviation of their unemployment rate from the Union average is capped at a maximum of 75 %. The maximum financial contribution of a Member State under the Facility (MFCi) is defined as follows: MFCi = \u03bd i \u00d7 (FS) where: FS (Financial Support) is the available financing under the Facility as referred to in Article 6(1)(a); and \u03bdi is the allocation key of Member State i, defined as: \u03bdi = 0,7 \u03bai + 0,3 \u03b1i where: \u03bai is the allocation key applied to 70 % of the amount referred to in point (a) of Article 6(1) and set out in Annex II; and \u03b1i is the allocation key applied to 30 % of the amount referred to in point (a) of Article 6(1) and set out in Annex III. ANNEX II The allocation key applied to 70 % of the amount referred to in point (a) of Article 6(1), \u03bai is defined as follows: , where and , with , \u03c5i \u2264 0,75 for Member States with and \u03c5i \u2264 1,5 for Member States with . Defining (1): \u2014 as the 2019 nominal GDP per capita of Member State i; \u2014 as the 2019 weighted average of GDP per capita of the EU-27 Member States; \u2014 popi,2019 as the 2019 total population in Member State i; \u2014 popEU,2019 as the 2019 total population in the EU-27 Member States; \u2014 Ui,2015-2019 as the average unemployment rate over the period 2015-2019 of Member State i; \u2014 UEU,2015-2019 as the average unemployment rate over the period 2015-2019 in the EU-27 (in each year the weighted average of the EU-27 Member States); \u2014 as the 2019 GNI per capita of Member State i; \u2014 as the 2019 weighted average GNI per capita of the EU-27 Member States. (1) All data in the regulation is from Eurostat; cut-off date May 2020 for historical data. ANNEX III The allocation key applied to 30 % of the amount referred to in Article 6(1)(a), \u03b1i, is defined as follows: where and where , and with Defining: \u2014 GDPi,t as the real GDP of Member State i at time t = 2019, 2020, 2021; \u2014 as the 2019 GDP per capita of Member State i; \u2014 as the 2019 weighted average of GDP per capita of the EU-27 Member States; \u2014 popi,2019 as the 2019 total population in Member State i; \u2014 popEU,2019 as the 2019 total population in the EU-27 Member States. The fall in real GDP for 2020 (\u03b4GDPi,2020\u20132019) and the cumulative fall in real GDP for the period 2020-2021 (\u03b4GDPi,2020\u20132019) shall be based on the Commission Autumn 2020 forecasts and updated by 30 June 2022 for each Member State replacing the data from the Commission Autumn 2020 forecasts with the actual outturns as reported in the latest available update of the Eurostat code series \u2018tec00115 (Real GDP growth rate - volume)\u2019. ANNEX IV The application of the methodologies in Annexes I, II and III to the amount referred to in Article 6(1)(a), converted into current prices, will result in the following share and amount of the maximum financial contribution per Member State, without prejudice to the updated calculation by 30 June 2022: Maximum financial contribution per EU Member State for 70 % of the amount available for 30 % of the amount available (Indicative amount based on the Commission Autumn 2020 forecasts) Share as % of total Amount (in EUR 1 000 , current prices) Share as % of total Amount (in EUR 1 000 , current prices) Total BE 1,56 % 3 646 437 2,20 % 2 278 834 5 925 271 BG 1,98 % 4 637 074 1,58 % 1 631 632 6 268 706 CZ 1,51 % 3 538 166 3,41 % 3 533 509 7 071 676 DK 0,56 % 1 303 142 0,24 % 248 604 1 551 746 DE 6,95 % 16 294 947 9,01 % 9 324 228 25 619 175 EE 0,32 % 759 715 0,20 % 209 800 969 515 IE 0,39 % 914 572 0,07 % 74 615 989 186 EL 5,77 % 13 518 285 4,11 % 4 255 610 17 773 895 ES 19,88 % 46 603 232 22,15 % 22 924 818 69 528 050 FR 10,38 % 24 328 797 14,54 % 15 048 278 39 377 074 HR 1,98 % 4 632 793 1,61 % 1 664 039 6 296 831 IT 20,45 % 47 935 755 20,25 % 20 960 078 68 895 833 CY 0,35 % 818 396 0,18 % 187 774 1 006 170 LV 0,70 % 1 641 145 0,31 % 321 944 1 963 088 LT 0,89 % 2 092 239 0,13 % 132 450 2 224 690 LU 0,03 % 76 643 0,02 % 16 883 93 526 HU 1,98 % 4 640 462 2,45 % 2 535 376 7 175 838 MT 0,07 % 171 103 0,14 % 145 371 316 474 NL 1,68 % 3 930 283 1,96 % 2 032 041 5 962 324 AT 0,95 % 2 231 230 1,19 % 1 230 938 3 462 169 PL 8,65 % 20 275 293 3,46 % 3 581 694 23 856 987 PT 4,16 % 9 760 675 4,01 % 4 149 713 13 910 387 RO 4,36 % 10 213 809 3,90 % 4 034 211 14 248 020 SI 0,55 % 1 280 399 0,48 % 496 924 1 777 322 SK 1,98 % 4 643 840 1,63 % 1 686 154 6 329 994 FI 0,71 % 1 661 113 0,41 % 424 692 2 085 805 SE 1,24 % 2 911 455 0,36 % 377 792 3 289 248 EU27 100,00 % 234 461 000 100,00 % 103 508 000 337 969 000 ANNEX V Assessment guidelines for the Facility 1. Scope The purpose of these guidelines is to serve together with this Regulation as a basis for the Commission to assess - in a transparent and equitable manner - the recovery and resilience plans proposed by Member States and to determine the financial contribution in conformity with the objectives and any other relevant requirements laid down in this Regulation. These guidelines represent the basis for the application of the assessment criteria and the determination of the financial contribution as referred to, respectively, in Articles 19(3) and 20(4). The assessment guidelines are designed to: (a) give further guidance on the assessment process of the proposals for recovery and resilience plans submitted by Member States; (b) provide further details on the assessment criteria and provide for a rating system to be established with a view to ensuring an equitable and transparent process; and (c) define the link between the assessment to be made by the Commission under the assessment criteria and the determination of the financial contribution to be set out in the Commission proposal for a Council decision in relation to the recovery and resilience plans. The guidelines are a tool to facilitate assessment by the Commission of the proposals for recovery and resilience plans as submitted by Member States and to ensure that the recovery and resilience plans support reforms and public investment that are relevant and display high added value with regard to the objectives of the Facility, while ensuring equal treatment among the Member States. 2. Assessment criteria In accordance with Article 19(3), the Commission shall assess the recovery and resilience plans under the criteria of relevance, effectiveness, efficiency and coherence. As a result of the assessment process, the Commission shall give ratings to the recovery and resilience plans submitted by the Member States under each of the assessment criteria referred to in Article 19(3), with a view to establishing the financial allocation in accordance with Article 20(4). For the sake of simplification and efficiency, the rating system shall range from A to C, as set out in the following: Relevance: 2.1. The recovery and resilience plan represents a comprehensive and adequately balanced response to the economic and social situation, thereby contributing appropriately to all six pillars referred to in Article 3, taking the specific challenges and the financial allocation of the Member State concerned into account. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the recovery and resilience plan contributes in a comprehensive and adequately balanced manner to all six pillars referred to in Article 3, considering the specific challenges of the Member State concerned and taking into account the financial contribution of the Member State concerned and the requested loan support. Rating A \u2013 to a large extent B \u2013 to a moderate extent C \u2013 to a small extent 2.2. The recovery and resilience plan is expected to contribute to effectively addressing all or a significant subset of challenges identified in the relevant country-specific recommendations including fiscal aspects thereof and recommendations made pursuant to Article 6 of Regulation (EU) No 1176/2011 where appropriate, addressed to the Member State concerned or challenges identified in other relevant documents officially adopted by the Commission in the context of the European Semester. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the recovery and resilience plan is expected to contribute to effectively addressing all or a significant subset of challenges identified in the relevant country-specific recommendations, including fiscal aspects thereof and recommendations made pursuant to Article 6 of Regulation (EU) No 1176/2011 where appropriate, addressed to the Member State concerned or challenges identified in other relevant documents officially adopted by the Commission in the context of the European Semester, taking into account the financial contribution of the Member State concerned and the requested loan support as well as the scope and scale of country-specific challenges and the information included in the National Reform Programme; and \u2014 the recovery and resilience plan represents a comprehensive and adequate response to the economic and social situation of the Member State concerned; and \u2014 the challenges addressed by the recovery and resilience plan are considered as significant to boost the growth potential of the economy of the Member State concerned in a sustainable manner; and \u2014 following the completion of the proposed reforms and investments, the related challenges would be expected to have been resolved or addressed in a manner that significantly contributes to their resolution. Rating A \u2013 the recovery and resilience plan contributes to effectively addressing all or a significant subset of challenges identified in the country-specific recommendations, or challenges in other relevant documents officially adopted by the Commission under the European Semester, and the recovery and resilience plan represents an adequate response to the economic and social situation of the Member State concerned B \u2013 the recovery and resilience plan contributes to partially addressing all or a significant subset of challenges identified in the country-specific recommendations, or challenges in other relevant documents officially adopted by the Commission under the European Semester and the recovery and resilience plan represents an adequate response to the economic and social situation of the Member State concerned C \u2013 the recovery and resilience plan does not contribute to addressing any challenges identified in the country-specific recommendations, or in other relevant documents officially adopted by the Commission under the European Semester and the recovery and resilience plan does not represent an adequate response to the economic and social situation of the Member State concerned 2.3. The recovery and resilience plan is expected to effectively contribute to strengthening the growth potential, job creation, and economic, social and institutional resilience of the Member State, contributing to the implementation of the European Pillar of Social Rights, including through the promotion of policies for children and youth, and to mitigating the economic and social impact of the COVID-19 crisis, thereby enhancing the economic, social and territorial cohesion and convergence within the Union. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the recovery and resilience plan contains measures that aim to foster economic growth and economic cohesion in an inclusive manner, in particular addressing weaknesses of the economy of the Member States, boosting the growth potential of the economy of the Member State concerned, stimulating job creation, and mitigating the adverse effects of the crisis; and \u2014 the recovery and resilience plan contains measures that aim to strengthen social cohesion and social protection systems, including policies for children and youth, by reducing social vulnerabilities, contributing to the implementation of the principles of the European Pillar of Social Rights and contributing to improving the levels of the indicators of its Social Scoreboard; and \u2014 the recovery and resilience plan aims to reduce economic vulnerabilities of the Member State to shocks; and \u2014 the recovery and resilience plan aims to increase the capacity of the economic and/or social structures and institutions of the Member State to adjust to and withstand shocks; and \u2014 the recovery and resilience plan is expected to contribute to enhancing economic, social and territorial cohesion and convergence. Rating A \u2013 high expected impact B \u2013 medium expected impact C \u2013 low expected impact 2.4. The recovery and resilience plan is expected to ensure that no measure for the implementation of reforms and investments projects included in the recovery and resilience plan does significant harm to environmental objectives within the meaning of Article 17 of Regulation (EU) 2020/852 (the principle of \u2018do no significant harm\u2019). The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 no measure for the implementation of reforms and investments projects included in the recovery and resilience plan does significant harm to environmental objectives within the meaning of Article 17 of Regulation (EU) 2020/852 (the principle of \u2018do no significant harm\u2019). Rating A \u2013 no measure does significant harm to environmental objectives (the principle of \u2018do no significant harm\u2019) C \u2013 one or more measure does significant harm to environmental objectives (the principle of \u2018do no significant harm\u2019) 2.5. The recovery and resilience plan contains measures that effectively contribute to the green transition, including biodiversity, or to addressing the challenges resulting therefrom, and that account for an amount which represents at least 37 % of the recovery and resilience plan\u2019s total allocation, based on the methodology for climate tracking set out in Annex VI; that methodology shall be used accordingly for measures that cannot be directly assigned to an intervention field listed in Annex VI; the coefficients for support for the climate objectives may be increased up to a total amount of 3 % of the allocation of the recovery and resilience plan for individual investments to take account of accompanying reform measures that credibly increase their impact on the climate objectives, subject to the agreement of the Commission. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the implementation of the envisaged measures is expected to effectively contribute to the green transition, including biodiversity, and, where applicable, to addressing the challenges resulting therefrom, thereby contributing to the achievement of the Union 2030 climate targets while complying with the objective of EU climate neutrality by 2050; and \u2014 Member States apply a methodology consisting of assigning a specific weighting to the support provided, which reflects the extent to which such support makes a contribution to climate objectives. The weightings shall be based on the dimensions and codes for the types of intervention established in Annex VI and may be increased for individual investments to take account of accompanying reform measures that credibly increase their impact on the climate objectives. The same weighting system shall apply for measures that cannot be directly assigned to an intervention field listed in Annex VI; and \u2014 the implementation of the envisaged measures is expected to have a lasting impact. Rating A \u2013 to a large extent B \u2013 to a moderate extent. C \u2013 to a small extent 2.6. The recovery and resilience plan contains measures that effectively contribute to the digital transition or to addressing the challenges resulting therefrom, and that account for an amount which represents at least 20 % of the recovery and resilience plan\u2019s total allocation, based on the methodology for digital tagging set out in Annex VII; that methodology shall be used accordingly for measures that cannot be directly assigned to an intervention field listed in Annex VII; the coefficients for support for the digital objectives may be increased for individual investments to take account of accompanying reform measures that increase their impact on the digital objectives. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the implementation of the envisaged measures is expected to significantly contribute to the digital transformation of economic or social sectors; or \u2014 the implementation of the envisaged measures is expected to significantly contribute to address the challenges resulting from digital transition; and \u2014 Member States apply a methodology consisting of assigning a specific weighting to the support provided, which reflects the extent to which such support makes a contribution to digital objectives. The weightings shall be based on the dimensions and codes for the types of intervention established in Annex VII and may be increased for individual investments to take account of accompanying reform measures that increase their impact on the digital objectives. The same weighting system shall apply for measures that cannot be directly assigned to an intervention field listed in Annex VII; and \u2014 the implementation of the envisaged measures is expected to have a lasting impact. Rating A \u2013 to a large extent B \u2013 to a moderate extent C \u2013 to a small extent Effectiveness: 2.7. The recovery and resilience plan is expected to have a lasting impact on the Member State concerned. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the implementation of the envisaged measures is expected to bring about a structural change in the administration or in relevant institutions; or \u2014 the implementation of the envisaged measures is expected to bring about a structural change in relevant policies; and \u2014 the implementation of the envisaged measures is expected to have a lasting impact. Rating A \u2013 to a large extent B \u2013 to a moderate extent C \u2013 to a small extent 2.8. The arrangements proposed by the Member States concerned are expected to ensure effective monitoring and implementation of the recovery and resilience plan, including the envisaged timetable, milestones and targets, and the related indicators. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 a structure is tasked within the Member State with: (i) the implementation of the recovery and resilience plan; (ii) the monitoring of progress on milestones and targets; and (iii) the reporting; and \u2014 the proposed milestones and targets are clear and realistic and the proposed indicators for those milestones and targets are relevant, acceptable and robust; and \u2014 the overall arrangements proposed by the Member States in terms of organisation (including provision to ensure sufficient staff allocation) of the implementation of the reforms and investments, are credible. Rating A \u2013 adequate arrangements for effective implementation B \u2013 minimum arrangements for effective implementation C \u2013 insufficient arrangements for effective implementation Efficiency: 2.9. The justification provided by the Member State on the amount of the estimated total costs of the recovery and resilience plan is reasonable and plausible and is in line with the principle of cost efficiency and is commensurate to the expected national economic and social impact. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the Member State provided sufficient information and evidence that the amount of the estimated total costs of the recovery and resilience plan is appropriate (reasonable); and \u2014 the Member State provided sufficient information and evidence that the amount of the estimated total costs of the recovery and resilience plan is in line with the nature and the type of the envisaged reforms and investments (plausible); and \u2014 the Member State provided sufficient information and evidence that the amount of the estimated total costs of the recovery and resilience plan to be financed under the Facility is not covered by existing or planned Union financing; and \u2014 the amount of the estimated total costs of the recovery and resilience plan is commensurate to the expected social and economic impact of the envisaged measures included on the Member State concerned. Rating A \u2013 to a high extent B \u2013 to a medium extent C \u2013 to a low extent 2.10. The arrangements proposed by the Member State concerned are expected to prevent, detect and correct corruption, fraud and conflicts of interests when using the funds provided under the Facility, including the arrangements that aim to avoid double funding from the Facility and other Union programmes. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the internal control system described in the recovery and resilience plan is based on robust processes and structures, and identifies clear actors (bodies/entities) and their roles and responsibilities for the performance of the internal control tasks; it notably ensures appropriate segregation of relevant functions; and \u2014 the control system and other relevant arrangements, including for the collection and making available of data on final recipients described in the recovery and resilience plan, in particular to prevent, detect and correct corruption, fraud and conflicts of interests when using the funds provided under the Facility are adequate; and \u2014 the arrangements described in the recovery and resilience plan to avoid double funding from the Facility and other Union programmes are adequate; and \u2014 the actors (bodies/entities) responsible for controls have the legal empowerment and administrative capacity to exercise their foreseen roles and tasks. Rating A \u2013 adequate arrangements C \u2013 insufficient arrangements Coherence: 2.11. The recovery and resilience plan contains measures for the implementation of reforms and public investment projects that represent coherent actions. The Commission shall take into account the following elements for the assessment under this criterion: Scope \u2014 the recovery and resilience plan includes measures that contribute to reinforcing the effects of one another; or \u2014 the recovery and resilience plan includes measures that are complementary to one another. Rating A \u2013 to a high extent B \u2013 to a medium extent C \u2013 to a low extent 3. Determination of the financial contribution In accordance with Article 20, the Commission proposal shall determine the financial contribution taking into account the importance and coherence of the recovery and resilience plan proposed by the Member State concerned, as assessed under the criteria set out in Article 19(3). For that purpose, it shall apply the following criteria: (a) where the recovery and resilience plan complies satisfactorily with the criteria set out in Article 19(3), and the amount of the estimated total costs of the recovery and resilience plan is equal to, or higher than, the maximum financial contribution calculated for that Member State in accordance with Article 11, the financial contribution allocated to the Member State concerned shall be equal to the total amount of the maximum financial contribution calculated for that Member State in accordance with Article 11; (b) where the recovery and resilience plan complies satisfactorily with the criteria set out in Article 19(3), and the amount of the estimated total costs of the recovery and resilience plan is lower than the maximum financial contribution calculated for that Member State in accordance with Article 11, the financial contribution allocated to the Member State shall be equal to the amount of the estimated total costs of the recovery and resilience plan; (c) where the recovery and resilience plan does not comply satisfactorily with the criteria set out in Article 19(3), no financial contribution shall be allocated to the Member State concerned. For the purpose of the implementation of this subparagraph, the following formulae shall apply: \u2014 for (a) above: If Ci \u2265 MFCi the Member State i receives MFCi \u2014 for (b) above: If Ci < MFCi the Member State i receives Ci where: \u2014 i refers to the Member State concerned \u2014 MFC is the maximum financial contribution for the Member State concerned \u2014 C is the amount of the estimated total costs of the recovery and resilience plan As a result of the assessment process, and taking into account the ratings: The recovery and resilience plan complies satisfactorily with the assessment criteria: If the final ratings for the criteria under point 2 include scores with: \u2014 an A for criteria 2.2, 2.3, 2.5 and 2.6; and for the other criteria: \u2014 all As, or \u2014 no majority of Bs over As and no Cs. The recovery and resilience plan does not comply satisfactorily with the assessment criteria: If the final ratings for the criteria under point 2 include scores with: \u2014 not an A in criteria 2.2, 2.3, 2.5 and 2.6; and for the other criteria: \u2014 a majority of Bs over As, or \u2014 at least one C. ANNEX VI Methodology for climate tracking Dimensions and codes for the types of intervention for the Facility INTERVENTION FIELD Coefficient for the calculation of support to climate change objectives Coefficient for the calculation of support to environmental objectives 001 Investment in fixed assets, including research infrastructure, in micro enterprises directly linked to research and innovation activities 0 % 0 % 002 Investment in fixed assets, including research infrastructure, in small and medium-sized enterprises (including private research centres) directly linked to research and innovation activities 0 % 0 % 002 bis1 Investment in fixed assets in large, including research infrastructure, enterprises (1) directly linked to research and innovation activities 0 % 0 % 003 Investment in fixed assets, including research infrastructure, in public research centres and higher education directly linked to research and innovation activities 0 % 0 % 004 Investment in intangible assets in micro enterprises directly linked to research and innovation activities 0 % 0 % 005 Investment in intangible assets in SMEs (including private research centres) directly linked to research and innovation activities 0 % 0 % 005bis1 Investment in intangible assets in large enterprises directly linked to research and innovation activities 0 % 0 % 006 Investment in intangible assets in public research centres and higher education directly linked to research and innovation activities 0 % 0 % 007 Research and innovation activities in micro enterprises including networking (industrial research, experimental development, feasibility studies) 0 % 0 % 008 Research and innovation activities in SMEs, including networking 0 % 0 % 008bis1 Research and innovation activities in large enterprises, including networking 0 % 0 % 009 Research and innovation activities in public research centres, higher education and centres of competence including networking (industrial research, experimental development, feasibility studies) 0 % 0 % 010 Digitising SMEs (including e-commerce, e- business and networked business processes, digital innovation hubs, living labs, web entrepreneurs and ICT start-ups, B2B) 0 % 0 % 010bis1 Digitising large enterprises (including e-commerce, e-business and networked business processes, digital innovation hubs, living labs, web entrepreneurs and ICT start-ups, B2B) 0 % 0 % 010ter Digitising SMEs or large enterprises (including e-commerce, e-business and networked business processes, digital innovation hubs, living labs, web entrepreneurs and ICT start-ups, B2B) compliant with GHG emission reduction or energy efficiency criteria (2) 40 % 0 % 011 Government ICT solutions, e-services, applications 0 % 0 % 011bis Government ICT solutions, e-services, applications compliant with GHG emission reduction or energy efficiency criteria (2) 40 % 0 % 012 IT services and applications for digital skills and digital inclusion 0 % 0 % 013 e-Health services and applications (including e-care, Internet of Things for physical activity and ambient assisted living) 0 % 0 % 014 Business infrastructure for SMEs (including industrial parks and sites) 0 % 0 % 015 SME business development and internationalisation, including productive investments 0 % 0 % 015bis Support for large enterprises through financial instruments, including productive investments 0 % 0 % 016 Skills development for smart specialisation, industrial transition, entrepreneurship and adaptability of enterprises to change 0 % 0 % 017 Advanced support services for SMEs and groups of SMEs (including management, marketing and design services) 0 % 0 % 018 Incubation, support to spin-offs and spin-outs and start-ups 0 % 0 % 019 Support for Innovation clusters including between businesses, research organisations and public authorities and business networks primarily benefiting SMEs 0 % 0 % 020 Innovation processes in SMEs (process, organisational, marketing, co-creation, user and demand driven innovation) 0 % 0 % 021 Technology transfer and cooperation between enterprises, research centres and higher education sector 0 % 0 % 022 Research and innovation processes, technology transfer and cooperation between enterprises focusing on the low carbon economy, resilience and adaptation to climate change 100 % 40 % 023 Research and innovation processes, technology transfer and cooperation between enterprises focusing on circular economy 40 % 100 % 024 Energy efficiency and demonstration projects in SMEs and supporting measures 40 % 40 % 024bis Energy efficiency and demonstration projects in large enterprises and supporting measures 40 % 40 % 024ter Energy efficiency and demonstration projects in SMEs or large enterprises and supporting measures compliant with energy efficiency criteria (3) 100 % 40 % 025 Energy efficiency renovation of existing housing stock, demonstration projects and supporting measures 40 % 40 % 025bis Energy efficiency renovation of existing housing stock, demonstration projects and supporting measures compliant with energy efficiency criteria (4) 100 % 40 % 025ter Construction of new energy efficient buildings (5) 40 % 40 % 026 Energy efficiency renovation or energy efficiency measures regarding public infrastructure, demonstration projects and supporting measures 40 % 40 % 026bis Energy efficiency renovation or energy efficiency measures regarding public infrastructure, demonstration projects and supporting measures compliant with energy efficiency criteria (6) 100 % 40 % 027 Support to enterprises that provide services contributing to the low carbon economy and to resilience to climate change including awareness-raising measures 100 % 40 % 028 Renewable energy: wind 100 % 40 % 029 Renewable energy: solar 100 % 40 % 030 Renewable energy: biomass (7) 40 % 40 % 030bis Renewable energy: biomass with high GHG savings (8) 100 % 40 % 031 Renewable energy: marine 100 % 40 % 032 Other renewable energy (including geothermal energy) 100 % 40 % 033 Smart Energy Systems (including smart grids and ICT systems) and related storage. 100 % 40 % 034 High efficiency co-generation, district heating and cooling 40 % 40 % 034bis0 High efficiency co-generation, efficient district heating and cooling with low lifecycle emissions (9) 100 % 40 % 034bis1 Replacement of coal-based heating systems by gas-based heating systems for climate mitigation purposes 0 % 0 % 034bis2 Distribution and transport of natural gas substituting coal 0 % 0 % 035 Adaptation to climate change measures and prevention and management of climate related risks: floods (including awareness raising, civil protection and disaster management systems, infrastructures and ecosystem based approaches) 100 % 100 % 036 Adaptation to climate change measures and prevention and management of climate related risks: fires (including awareness raising, civil protection and disaster management systems, infrastructures and ecosystem based approaches) 100 % 100 % 037 Adaptation to climate change measures and prevention and management of climate related risks: others, e.g. storms and drought (including awareness raising, civil protection and disaster management systems, infrastructures and ecosystem based approaches) 100 % 100 % 038 Risk prevention and management of non-climate-related natural risks (for example earthquakes) and risks linked to human activities (for example technological accidents), including awareness raising, civil protection and disaster management systems, infrastructures and ecosystem based approaches 0 % 100 % 039 Provision of water for human consumption (extraction, treatment, storage and distribution infrastructure, efficiency measures, drinking water supply) 0 % 100 % 039bis Provision of water for human consumption (extraction, treatment, storage and distribution infrastructure, efficiency measures, drinking water supply) compliant with efficiency criteria (10) 40 % 100 % 040 Water management and water resource conservation (including river basin management, specific climate change adaptation measures, reuse, leakage reduction) 40 % 100 % 041 Waste water collection and treatment 0 % 100 % 041bis Waste water collection and treatment compliant with energy efficiency criteria (11) 40 % 100 % 042 Household waste management: prevention, minimisation, sorting, reuse, recycling measures 40 % 100 % 042bis Household waste management: residual waste management 0 % 100 % 044 Commercial, industrial waste management: prevention, minimisation, sorting, reuse, recycling measures 40 % 100 % 044bis Commercial, industrial waste management: residual and hazardous waste 0 % 100 % 045 Promoting the use of recycled materials as raw materials 0 % 100 % 045bis Use of recycled materials as raw materials compliant with the efficiency criteria (12) 100 % 100 % 046 Rehabilitation of industrial sites and contaminated land 0 % 100 % 046bis Rehabilitation of industrial sites and contaminated land compliant with efficiency criteria (13) 40 % 100 % 047 Support to environmentally-friendly production processes and resource efficiency in SMEs 40 % 40 % 047bis Support to environmentally-friendly production processes and resource efficiency in large enterprises 40 % 40 % 048 Air quality and noise reduction measures 40 % 100 % 049 Protection, restoration and sustainable use of Natura 2000 sites. 40 % 100 % 050 Nature and biodiversity protection, natural heritage and resources, green and blue infrastructure 40 % 100 % 051 ICT: Very High-Capacity broadband network (backbone/backhaul network) 0 % 0 % 052 ICT: Very High-Capacity broadband network (access/local loop with a performance equivalent to an optical fibre installation up to the distribution point at the serving location for multi-dwelling premises) 0 % 0 % 053 ICT: Very High-Capacity broadband network (access/local loop with a performance equivalent to an optical fibre installation up to the distribution point at the serving location for homes and business premises) 0 % 0 % 054 ICT: Very High-Capacity broadband network (access/local loop with a performance equivalent to an optical fibre installation up to the base station for advanced wireless communication) 0 % 0 % 055 ICT: Other types of ICT infrastructure (including large-scale computer resources/equipment, data centres, sensors and other wireless equipment) 0 % 0 % 055bis ICT: Other types of ICT infrastructure (including large-scale computer resources/equipment, data centres, sensors and other wireless equipment) compliant with the carbon emission reduction and energy efficiency criteria (2) 40 % 0 % 056 Newly built or upgraded motorways and roads - TEN-T core network (14) 0 % 0 % 057 Newly built or upgraded motorways and roads - TEN-T comprehensive network 0 % 0 % 058 Newly built or upgraded secondary road links to TEN-T road network and nodes 0 % 0 % 059 Newly built or upgraded other national, regional and local access roads 0 % 0 % 060 Reconstructed or modernised motorways and roads - TEN-T core network 0 % 0 % 061 Reconstructed or modernised motorways and roads - TEN-T comprehensive network 0 % 0 % 062 Other reconstructed or modernised roads (motorway, national, regional or local) 0 % 0 % 063 Digitalisation of transport: road 0 % 0 % 063bis Digitalisation of transport when dedicated in part to GHG emissions reduction: road 40 % 0 % 064 Newly built or upgraded railways - TEN-T core network 100 % 40 % 065 Newly built or upgraded railways - TEN-T comprehensive network 100 % 40 % 066 Other newly or upgraded built railways 40 % 40 % 066bis Other newly or upgraded built railways \u2013 electric/zero emission (15) 100 % 40 % 067 Reconstructed or modernised railways - TEN-T core network 100 % 40 % 068 Reconstructed or modernised railways - TEN-T comprehensive network 100 % 40 % 069 Other reconstructed or modernised railways 40 % 40 % 069bis Other reconstructed or modernised railways \u2013 electric/zero emission (15) 100 % 40 % 070 Digitalisation of transport: rail 40 % 0 % 071 European Rail Traffic Management System (ERTMS) 40 % 40 % 072 Mobile rail assets 0 % 40 % 072bis Mobile zero emission/electric powered (16) rail assets 100 % 40 % 073 Clean urban transport infrastructure (17) 100 % 40 % 074 Clean urban transport rolling stock (18) 100 % 40 % 075 Cycling infrastructure 100 % 100 % 076 Digitalisation of urban transport 0 % 0 % 076bis Digitalisation of transport when dedicated in part to GHG emissions reduction: urban transport 40 % 0 % 077 Alternative fuels infrastructure (19) 100 % 40 % 078 Multimodal transport (TEN-T) 40 % 40 % 079 Multimodal transport (not urban) 40 % 40 % 080 Seaports (TEN-T) 0 % 0 % 080bis Seaports (TEN-T) excluding facilities dedicated to transport of fossil fuels 40 % 0 % 081 Other seaports 0 % 0 % 081bis Other seaports excluding facilities dedicated to transport of fossil fuels 40 % 0 % 082 Inland waterways and ports (TEN-T) 0 % 0 % 082bis Inland waterways and ports (TEN-T) excluding facilities dedicated to transport of fossil fuels 40 % 0 % 083 Inland waterways and ports (regional and local) 0 % 0 % 083bis0 Inland waterways and ports (regional and local) excluding facilities dedicated to transport of fossil fuels 40 % 0 % 083bis1 Security, safety and air traffic management systems, for existing airports 0 % 0 % 084 Digitising transport: other transport modes 0 % 0 % 084bis Digitising transport when dedicated in part to GHG emissions reduction: other transport modes 40 % 0 % 085 Infrastructure for early childhood education and care 0 % 0 % 086 Infrastructure for primary and secondary education 0 % 0 % 087 Infrastructure for tertiary education 0 % 0 % 088 Infrastructure for vocational education and training and adult learning 0 % 0 % 089 Housing infrastructure for migrants, refugees and persons under or applying for international protection 0 % 0 % 090 Housing infrastructure (other than for migrants, refugees and persons under or applying for international protection) 0 % 0 % 091 Other social infrastructure contributing to social inclusion in the community 0 % 0 % 092 Health infrastructure 0 % 0 % 093 Health equipment 0 % 0 % 094 Health mobile assets 0 % 0 % 095 Digitalisation in health care 0 % 0 % 096 Temporary reception infrastructure for migrants, refugees and persons under or applying for international protection 0 % 0 % 097 Measures to improve access to employment 0 % 0 % 098 Measures to promote access to employment of long-term unemployed 0 % 0 % 099 Specific support for youth employment and socio-economic integration of young people 0 % 0 % 100 Support for self-employment and business start-ups 0 % 0 % 101 Support for social economy and social enterprises 0 % 0 % 102 Measures to modernise and strengthen labour market institutions and services to assess and anticipate skills needs and to ensure timely and tailor-made assistance 0 % 0 % 103 Support for labour market matching and transitions 0 % 0 % 104 Support for labour mobility 0 % 0 % 105 Measures to promote women\u2019s labour market participation and reduce gender-based segregation in the labour market 0 % 0 % 106 Measures promoting work-life balance, including access to childcare and care for dependent persons 0 % 0 % 107 Measures for a healthy and well\u2013adapted working environment addressing health risks, including promotion of physical activity 0 % 0 % 108 Support for the development of digital skills 0 % 0 % 109 Support for adaptation of workers, enterprises and entrepreneurs to change 0 % 0 % 110 Measures encouraging active and healthy ageing 0 % 0 % 111 Support for early childhood education and care (excluding infrastructure) 0 % 0 % 112 Support for primary to secondary education (excluding infrastructure) 0 % 0 % 113 Support for tertiary education (excluding infrastructure) 0 % 0 % 114 Support for adult education (excluding infrastructure) 0 % 0 % 115 Measures to promote equal opportunities and active participation in society 0 % 0 % 116 Pathways to integration and re-entry into employment for disadvantaged people 0 % 0 % 117 Measures to improve access of marginalised groups such as the Roma to education, employment and to promote their social inclusion 0 % 0 % 118 Support to the civil society working with marginalised communities such as the Roma 0 % 0 % 119 Specific actions to increase participation of third-country nationals in employment 0 % 0 % 120 Measures for the social integration of third-country nationals 0 % 0 % 121 Measures to enhancing the equal and timely access to quality, sustainable and affordable services 0 % 0 % 122 Measures to enhancing the delivery of family and community-based care services 0 % 0 % 123 Measures to improve the accessibility, effectiveness and resilience of healthcare systems (excluding infrastructure) 0 % 0 % 124 Measures to improve access to long-term care (excluding infrastructure) 0 % 0 % 125 Measures to modernise social protection systems, including promoting access to social protection 0 % 0 % 126 Promoting social integration of people at risk of poverty or social exclusion, including the most deprived and children 0 % 0 % 127 Addressing material deprivation through food and/or material assistance to the most deprived, including accompanying measures 0 % 0 % 128 Protection, development and promotion of public tourism assets and tourism services 0 % 0 % 129 Protection, development and promotion of cultural heritage and cultural services 0 % 0 % 130 Protection, development and promotion of natural heritage and eco-tourism other than Natura 2000 sites 0 % 100 % 131 Physical regeneration and security of public spaces 0 % 0 % 131bis Territorial development initiatives, including preparation of territorial strategies 0 % 0 % 132 Improve the capacity of programme authorities and bodies linked to the implementation of the Funds 0 % 0 % 133 Enhancing cooperation with partners both within and outside the Member State 0 % 0 % 134 Cross-financing under the ERDF (support to ESF-type actions necessary for the implementation of the ERDF part of the operation and directly linked to it) 0 % 0 % 135 Enhancing institutional capacity of public authorities and stakeholders to implement territorial cooperation projects and initiatives in a cross-border, transnational, maritime and inter-regional context 0 % 0 % 135 bis Interreg: border crossing management and mobility and migration management 0 % 0 % 136 Outermost regions: compensation of any additional costs due to accessibility deficit and territorial fragmentation 0 % 0 % 137 Outermost regions: specific action to compensate additional costs due to size market factors 0 % 0 % 138 Outermost regions: support to compensate additional costs due to climate conditions and relief difficulties 40 % 40 % 139 Outermost regions: airports 0 % 0 % 140 Information and communication 0 % 0 % 141 Preparation, implementation, monitoring and control 0 % 0 % 142 Evaluation and studies, data collection 0 % 0 % 143 Reinforcement of the capacity of Member State authorities, beneficiaries and relevant partners 0 % 0 % 01 Contributing to green skills and jobs and the green economy 100 % (1) Large enterprises are all enterprises other than SMEs, including small mid-cap companies. (2) If the objective of the measure is that the activity has to process or collect data to enable GHG emission reductions that result in demonstrated substantial life-cycle GHG emissions savings. If the objective of the measure requires data centres to comply with \u201cEuropean Code of Conduct on Data Centre Energy Efficiency\u201d. (3) (a) If the objective of the measure is to achieve, on average, at least a medium-depth level renovation as defined in Commission Recommendation on Building Renovation (EU) 2019/786 or (b) if the objective of the measures is to achieve, on average, at least a 30 % reduction of direct and indirect GHG emissions compared to the ex-ante emissions. (4) If the objective of the measure is to achieve, on average, at least a medium-depth level renovation as defined in Commission Recommendation on Building Renovation (EU) 2019/786. The renovation of buildings is also meant to include infrastructure in the sense of intervention fields 85 to 92. (5) If the objective of the measures concerns the construction of new buildings with a Primary Energy Demand (PED) that is at least 20 % lower than the NZEB requirement (nearly zero-energy building, national directives). The construction of new energy efficient buildings is also meant to include infrastructure in the sense of intervention fields 85 to 92. (6) If the objective of the measure is (a) to achieve, on average, at least a medium-depth level renovation as defined in Commission Recommendation on Building Renovation (EU) 2019/786 or (b) to achieve, on average, at least a 30 % reduction of direct and indirect GHG emissions compared to the ex-ante emissions. The renovation of buildings is also meant to include infrastructure in the sense of intervention fields 85 to 92. (7) If the objective of the measure relates to the production of electricity or heat from biomass in line with Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). (8) If the objective of the measure relates to the production of electricity or heat from biomass in line with Directive (EU) 2018/2001; and if the objective of the measure is to achieve at least 80 % GHG emission savings at the facility from the use of biomass in relation to the GHG saving methodology and the relative fossil fuel comparator set out in Annex VI to Directive (EU) 2018/2001. If the objective of the measure relates to the production of biofuel from biomass (excluding food and feed crops), in line with Directive (EU) 2018/2001; and if the objective of the measure is to achieve at least 65 % GHG emission savings at the facility from the use of biomass for this purpose in relation to the GHG saving methodology and the relative fossil fuel comparator set out in Annex V to Directive (EU) 2018/2001. (9) In case of high-efficiency cogeneration, if the objective of the measure is to achieve life cycle emissions that are lower than 100gCO2e/kWh or heat/cool produced from waste heat. In case of district heating/cooling, if the associated infrastructure follows the Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1) or the existing infrastructure is refurbished to meet the definition of the efficient district heating and cooling, or the project is an advanced pilot system (control and energy management systems, Internet of Things) or leads to a lower temperature regime in the district heating and cooling system. (10) If the objective of the measure is for the constructed system to have an average energy consumption of \u2264 0,5 kWh or an Infrastructure Leakage Index (ILI) of \u2264 1,5, and for the renovation activity to decrease the average energy consumption by more than 20 % or decrease leakage by more than 20 %. (11) If the objective of the measure for the constructed front-to-end waste water system to have net zero energy use or for the renewal of the front-to-end waste water system to lead to a decreased average energy use by at least 10 % (solely by energy efficiency measures and not by material changes or changes in load). (12) If the objective of the measure is to convert at least 50 %, in terms of weight, of the processed separately collected non-hazardous waste into secondary raw materials. (13) If the objective of the measure is to turn industrial sites and contaminated land into a natural carbon sink. (14) For intervention fields 56 to 62, intervention fields 73, 74 and 77 can be used for elements of the measures that relate to interventions in alternative fuels, including EV charging, or public transport. (15) If the objective of the measure relates to electrified trackside and associated subsystems or if there is a plan for electrification or it will be fit for use by zero tailpipe emission trains within 10 years. (16) Also applies to bi-mode trains. (17) Clean urban transport infrastructure refers to infrastructure that enables the operation of zero-emission rolling stock. (18) Clean urban transport rolling stock refers to zero-emission rolling stock. (19) If the objective of the measure is in line with Directive (EU) 2018/2001. ANNEX VII Methodology for digital tagging under the Facility Methodology for digital tagging: Intervention table Code Intervention field and type of intervention (1) Coefficient for the calculation of support to digital transition Intervention field 1: Connectivity DESI dimension 1: Connectivity 051 Very High-Capacity broadband network (backbone/backhaul network) (2) 100 % 052 Very High-Capacity broadband network (access/local loop with a performance equivalent to an optical fibre installation up to the distribution point at the serving location for multi-dwelling premises) 100 % 053 Very High-Capacity broadband network (access/local loop with a performance equivalent to an optical fibre installation up to the distribution point at the serving location for homes and business premises) 100 % 054 Very High-Capacity broadband network (access/local loop with a performance equivalent to an optical fibre installation up to the base station for advanced wireless communication) (3) 100 % 054bis 5G network coverage, including uninterrupted provision of connectivity along transport paths; Gigabit connectivity (networks offering at least 1 Gbps symmetric) for socio-economic drivers, such as schools, transport hubs and main providers of public services 100 % 054ter Mobile data connectivity with wide territorial coverage 100 % Intervention field 2: Digital-related investment in R&D DESI: \u201cThe EU ICT Sector and its R&D Performance\u201d 009bis Investment in digital-related R&I activities (including excellence research centres, industrial research, experimental development, feasibility studies, acquisition of fixed or intangible assets for digital related R&I activities) 100 % Intervention field 3: Human Capital DESI dimension 2: Human Capital 012 IT services and applications for digital skills and digital inclusion (4) 100 % 016 Skills development for smart specialisation, industrial transition, entrepreneurship, and adaptability of enterprises to change 40 % 108 Support for the development of digital skills (5) 100 % 099 Specific support for youth employment and socio-economic integration of young people 40 % 100 Support for self-employment and business start-ups 40 % Intervention field 4: e-government, digital public services and local digital ecosystems DESI dimension 5: Digital Public services 011 Government ICT solutions, e-services, applications (6) 100 % 011bis Government ICT solutions, e-services, applications compliant with GHG emission reduction or energy efficiency criteria (7) 100 % 011ter Deployment of the European digital identity scheme for public and private use 100 % 013 e-Health services and applications (including e-Care, Internet of Things for physical activity and ambient assisted living) 100 % 095 Digitalisation in health care 100 % 063 Digitalisation of transport: road 100 % 063bis Digitalisation of transport when dedicated in part to GHG emissions reduction: road 100 % 070 Digitalisation of transport: rail 100 % 071 European Rail Traffic Management System (ERTMS) 100 % 076 Digitalisation of urban transport 100 % 076bis Digitalisation of transport when dedicated in part to GHG emissions reduction: urban transport 100 % 084 Digitising transport: other transport modes 100 % 084bis Digitising transport when dedicated in part to GHG emissions reduction: other transport modes 100 % 033 Smart Energy Systems (including smart grids and ICT systems) and related storage 40 % 011quater Digitalisation of Justice Systems 100 % Intervention field 5: Digitalisation of businesses DESI dimension 4: Integration of digital technologies 010 Digitising SMEs (including e-Commerce, e-Business and networked business processes, digital innovation hubs, living labs, web entrepreneurs and ICT start-ups, B2B) 100 % 010bis Digitising large enterprises (including e-Commerce, e-Business and networked business processes, digital innovation hubs, living labs, web entrepreneurs and ICT start-ups, B2B) 100 % 010ter Digitising SMEs or large enterprises (including e-Commerce, e-Business and networked business processes, digital innovation hubs, living labs, web entrepreneurs and ICT start-ups, B2B) compliant with GHG emission reduction or energy efficiency criteria (7) 100 % 014 Business infrastructure for SMEs (including industrial parks and sites) (8) 40 % 015 SME business development and internationalisation, including productive investments (8) 40 % 017 Advanced support services for SMEs and groups of SMEs (including management, marketing and design services) (8) 40 % 018 Incubation, support to spin offs and spin outs and start ups (8) 40 % 019 Support for innovation clusters including between businesses, research organisations and public authorities and business networks primarily benefiting SMEs (8) (9) 40 % 020 Innovation processes in SMEs (process, organisational, marketing, co-creation, user and demand driven innovation) (8) 40 % 021 Technology transfer and cooperation between enterprises, research centres and higher education sector (8) 40 % 021bis Support to digital content production and distribution 100 % Intervention field 6: Investment in digital capacities and deployment of advanced technologies DESI dimension 4: Integration of digital technologies + ad hoc data collections 055 Other types of ICT infrastructure (including large-scale computer resources/equipment, data centres, sensors and other wireless equipment) 100 % 055bis Other types of ICT infrastructure (including large-scale computer resources/equipment, data centres, sensors and other wireless equipment) compliant with the carbon emission reduction and energy efficiency criteria (7) 100 % 021ter Development of highly specialised support services and facilities for public administrations and businesses (national HPC Competence Centres, Cyber Centres, AI testing and experimentation facilities, blockchain, Internet of Things, etc.) 100 % 021quater Investment in advanced technologies such as: High-Performance Computing and Quantum computing capacities/Quantum communication capacities (including quantum encryption); in microelectronics design, production and system-integration; next generation of European data, cloud and edge capacities (infrastructures, platforms and services); virtual and augmented reality, DeepTech and other digital advanced technologies. Investment in securing the digital supply chain. 100 % 021quinquies Development and deployment of cybersecurity technologies, measures and support facilities for public and private sector users. 100 % Intervention field 7: Greening the digital sector 027bis Investment in technologies, skills, infrastructures and solutions that improve the energy efficiency and ensure climate neutrality of data centres and networks. 100 % (1) The description of interventions in this table are without prejudice to compliance with competition rules, in particular to ensure that interventions do not crowd out private investments. (2) Including submarine cables within and between Member States and between the Union and third countries. (3) Including 5G and 6G networks. (4) Including: measures to support the digitalisation of education and training institutions (including investments in ICT infrastructure), including for vocational education and training and adult learning. (5) This refers to digital skills at all levels and includes: highly specialised education programmes to train digital specialists (that is technology focused programmes); training of teachers, development of digital content for education purposes and relevant organisational capabilities. This also includes measures and programmes aimed at improving basic digital skills. (6) Including use of advanced technologies (such as high performance computing, cybersecurity or artificial intelligence) for public services and decision making and interoperability of digital public services and infrastructures (regional, national and cross border). (7) If the objective of the measure is that the activity has to process or collect data to enable GHG emission reductions that result in demonstrated substantial life-cycle GHG emissions savings. If the objective of the measure requires data centres to comply with \u201cEuropean Code of Conduct on Data Centre Energy Efficiency\u201d. (8) The 40 % digital co-efficient should only be applied, where intervention is focused on elements directly linked to digitalisation of business, including for instance digital products, ICT assets, etc. (9) Including social economy entities.", "summary": "EU Recovery and Resilience Facility EU Recovery and Resilience Facility SUMMARY OF: Regulation (EU) 2021/241 establishing the Recovery and Resilience Facility WHAT IS THE AIM OF THE REGULATION? It establishes a Recovery and Resilience Facility (RRF) for the European Union (EU) and sets out the facility\u2019s aims and the criteria for receiving funding. KEY POINTS The RRF aims to promote the EU\u2019s economic, social and territorial cohesion by: improving EU Member States\u2019 resilience, crisis preparedness, adjustment capacity and growth potential; mitigating the social and economic impact of the COVID-19 crisis, particularly on women; contributing to the implementation of the European Pillar of Social Rights; supporting the green transition (see summary) and helping to achieve the EU\u2019s 2030 climate targets and 2050 climate neutrality objective; encouraging the digital transition. RRF funding is available for measures which \u2018do no significant harm\u2019, i.e. that do not harm the environment, and do not involve recurrent expenditure, in the following six pillars: the green transition; the digital transformation; smart, sustainable and inclusive growth; social and territorial cohesion; health, economic, social and institutional resilience; policies for the next generation, such as education and skills. The \u20ac723.8 billion (in current prices) budget: consists of: \u20ac338 billion in grants, of which the European Commission may allocate 70% up to 31 December 2022 and 30% during 2023,\u20ac385.8 billion in loans, which Member States may request until 31 August 2023 (a loan may not exceed 6.8% of the Member State\u2019s 2019 gross national income); does not replace recurring national budgetary expenditure, except in justified cases; supplements financial support under other EU programmes; respects the additionality principle* of EU funding. The economic governance rules state that: the Commission may propose suspending all or part of the funding to a Member State if the Council of the European Union decides it has not done enough to correct its excessive deficit; a proposal to suspend commitments* is adopted unless the Council rejects it by a qualified majority within 1 month; a proposal to suspend payments* requires the Council\u2019s approval; suspension of funding must be proportionate and take account of a Member State\u2019s economic and social circumstances; the Council may lift a suspension following a Commission proposal. Member States draw up national recovery and resilience plans, setting out their reform and investment agenda in a comprehensive and coherent package. These: may include measures from 1 February 2020; have to be consistent with: national challenges and priorities identified in the European semester,national reform programmes,national energy and climate plans,territorial \u2018Just Transition\u2019 plans,\u2018Youth Guarantee\u2019 implementation plans; must allocate at least 37% of the budget to climate measures, and 20% to digital measures. The Commission: assesses the plans according to their relevance, effectiveness, efficiency and coherence; if it proposes that the Council approves a national plan, sets out the milestones and targets that a country must meet in its reforms and investment projects, and the RRF\u2019s financial contribution; may reject or accept amendments to the plans; transmits the national plans to the European Parliament and the Council without delay; monitors the facility\u2019s implementation and measures the achievements made; establishes a recovery and resilience scoreboard; submits annual reports to the European Parliament and the Council. Member States: must prevent, detect and correct any fraud, corruption or conflict of interest when using EU funds; report twice a year on the progress of their plans in the context of the European semester. The relevant European Parliament committee may invite the Commission every 2 months to discuss progress under the facility. The Commission submits reports to the European Parliament and the Council: a review report by 31 July 2022; on the RRF\u2019s overall implementation by 20 February 2024 (also goes to the European Economic and Social Committee and the Committee of the Regions). Recovery and resilience scoreboard In December 2021, the Commission launched the recovery and resilience scoreboard, a public online platform which is designed to show progress made in the implementation of the RRF as a whole, and of the individual national recovery and resilience plans. Delegated act In defining a methodology for reporting social expenditure, Commission Delegated Regulation (EU) 2021/2105 supplements Regulation (EU) 2021/241. The methodology for reporting social expenditure, including on children and the youth, and on gender equality under the facility is based on the estimated expenditure provided in the approved recovery and resilience plans. FROM WHEN DOES THE REGULATION APPLY? It has applied since 19 February 2021. BACKGROUND The RRF is the centrepiece of the EU\u2019s \u20ac750 billion NextGenerationEU stimulus package. This allows the Commission to raise funds to help repair the immediate economic and social damage brought by the coronavirus pandemic. It is closely aligned with the Commission\u2019s priorities to ensure a sustainable and inclusive recovery that promotes the green and digital transition. For further information, see: The Recovery and Resilience Facility (European Commission). KEY TERMS Additionality principle. One of the underlying principles of the European structural and investment funds. This principle stipulates that European structural and investment funds\u2019 contributions must not replace public or equivalent structural expenditure by a Member State in the regions concerned. Commitments. The total cost of legal obligations (contracts, grant agreements/decisions) that could be signed in the current financial year. Payments. Appropriations covering expenditure due in the current year, arising from legal commitments entered in the current year and/or earlier years. MAIN DOCUMENT Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, pp. 17\u201375). Successive amendments to Regulation (EU) 2021/241 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2021/2105 of 28 September 2021 supplementing Regulation (EU) 2021/241 of the European Parliament and of the Council establishing the Recovery and Resilience Facility by defining a methodology for reporting social expenditure (OJ L 429, 1.12.2021, pp. 79\u201382). Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I, 22.12.2020, pp. 23\u201327). Regulation (EU, Euratom) 2020/2092 of the European Parliament and of the Council of 16 December 2020 on a general regime of conditionality for the protection of the Union budget (OJ L 433I, 22.12.2020, pp. 1\u201310). See consolidated version. Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2013 Building a European Health Union: Reinforcing the EU\u2019s resilience for cross-border health threats (COM(2020) 724 final, 11.11.2020). Communication from the Commission to the European Parliament, the European Council, the Council, the European Central Bank, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank \u2013 Annual Sustainable Growth Strategy 2021 (COM(2020) 575 final, 17.9.2020). European Semester: integrated country-specific recommendations, Council of the European Union, 24.6.2020. Communication from the Commission to the European Parliament, the European Council, the Council, the European Central Bank, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank \u2013 2020 European Semester: country-specific recommendations (COM(2020) 500 final, 20.5.2020). Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2013 The European Green Deal (COM(2019) 640 final, 11.12.2019). Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, pp. 1\u201377). See consolidated version. Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1\u2013222). last update 04.02.2022"}
{"article": "18.2.2021 EN Official Journal of the European Union L 57/1 REGULATION (EU) 2021/240 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 10 February 2021 establishing a Technical Support Instrument THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the third paragraph of Article 175 and Article 197(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) In accordance with Articles 120 and 121 of the Treaty on the Functioning of the European Union (TFEU), Member States are required to conduct their economic policies with a view to contributing to the achievement of the objectives of the Union and in the context of the broad guidelines that the Council formulates. Article 148 TFEU requires Member States to implement employment policies that take into account guidelines for employment drawn up by the Council. The coordination of Member States\u2019 economic policies is therefore a matter of common concern. (2) Article 175 TFEU requires, inter alia, Member States to coordinate their economic policies in such a way as to attain the objectives on economic, social and territorial cohesion set out in Article 174 thereof. (3) The COVID-19 outbreak in early 2020 changed the economic and social outlook for the years to come in the Union and in the world. In the Union, new priorities have emerged, linked with the crisis, specifically focussing on recovery and resilience. Those priorities require an urgent and coordinated response from the Union in order to cope with the economic, social and health-related consequences for Member States as well as to mitigate the social and economic fallout. In particular, women have been hit especially hard by the economic consequences of the COVID-19 crisis. The COVID-19 crisis, as well as the previous economic and financial crisis, has shown that developing sound and resilient economies and financial systems built on strong and sustainable economic and social structures helps Member States to respond more efficiently to shocks and to recover more swiftly from them. The need for preparedness of health systems, essential public services and effective social protection mechanisms was also clearly demonstrated. Growth-enhancing, sustainable, smart and socially responsible reforms and investments, sound fiscal policies and the creation of high-quality jobs to respond to the new challenges, address structural economic weaknesses and strengthen economic resilience will therefore be essential to setting the economy and society back on a sustainable recovery path and to overcoming the economic, social and territorial divergences in the Union. This should be done in the interest of the well-being of Union citizens and in accordance with relevant fundamental rights principles. (4) Regulation (EU) 2017/825 of the European Parliament and of the Council (4) established the Structural Reform Support Programme for the period 2017 to 2020, with a budget of EUR 142 800 000 at the moment of adoption. The Structural Reform Support Programme was established to strengthen the capacity of Member States to prepare and implement growth-sustaining administrative and structural reforms, including through assistance for the efficient and effective use of the Union funds. Technical support under the Structural Reform Support Programme is provided by the Commission, upon request from a Member State, and can cover a wide range of policy areas. This Regulation is designed as a continuation of that programme, which has been positively received by Member States, while incorporating relevant adjustments. (5) Member States have increasingly taken up technical support under the Structural Reform Support Programme. Therefore, this Regulation should establish a technical support instrument with a view to continuing and enhancing support for Member States in the implementation of reforms (the \u2018instrument\u2019). (6) At Union level, the European Semester for economic policy coordination is the framework that identifies challenges and national reform priorities and monitors the implementation of those priorities. Member States also develop their own national multiannual investment strategies in support of those priorities in the context of the European Semester. Those strategies are presented alongside the yearly National Reform Programmes as a way to outline and coordinate priorities to be supported by national or Union funding. They should also serve as a means of using Union funding in a coherent manner and of maximising the added value of the financial support to be received in particular from the programmes supported by the Union under the structural and cohesion funds and from other programmes. With regard to the challenges identified in the context of European Semester, the instrument would have a clear added value in assisting Member States to enhance their capacity to effectively address the country-specific recommendations. (7) Reflecting the European Green Deal as the Union\u2019s growth strategy and the translation of the Union\u2019s commitments to implement the Paris Agreement on climate change and the United Nations\u2019 Sustainable Development Goals, the instrument will contribute to the implementation of the European Green Deal, the mainstreaming of climate actions and the achievement of the overall target of 30 % of Union budget expenditure supporting climate objectives and the ambition of providing 7,5 % of annual spending under the Multiannual Financial Framework to biodiversity objectives from 2024 and 10 % in 2026 and 2027, while considering the existing overlaps between climate and biodiversity objectives. Relevant actions should be identified during the instrument\u2019s preparation and implementation and reassessed in the context of the relevant evaluations and review processes. The instrument should also tackle broader environmental and social challenges within the Union, including the protection of natural capital, preserving biodiversity and the support to the circular economy and the energy transition, in accordance with the 2030 Agenda for Sustainable Development. The instrument should also support the digital transition and contribute to the creation of the Digital Single Market. (8) The general objective of the instrument should be to promote the Union\u2019s economic, social and territorial cohesion by supporting Member States efforts to implement reforms. This is necessary to encourage public and private investments, support sustainable and fair economic and social recovery and convergence, achieve resilience, reduce poverty and inequality, promote gender equality, increase competitiveness, effectively address the challenges identified in the adopted country-specific recommendations and implement Union law. This is also necessary to support Member States\u2019 efforts to strengthen their institutional and administrative capacity and judicial framework, including at regional and local level, and their efforts to implement policy objectives to facilitate socially inclusive, green and digital transitions, in accordance with the Paris Agreement on climate change, the Union\u2019s 2030 climate and energy targets and climate neutrality by 2050 target, the United Nations Sustainable Development Goals and the European Pillar of Social Rights. (9) The specific objectives of the instrument should be to assist national authorities in their endeavours to design, develop and implement reforms and to prepare, amend, implement and revise recovery and resilience plans pursuant to Regulation (EU) 2021/241 of the European Parliament and of the Council (5), including through exchange of good practices, appropriate processes and methodologies, stakeholder involvement, where appropriate, and more effective and efficient human resources management. (10) In order to help Member States to design, develop and implement reforms in all the key economic and societal areas, the Commission should continue to provide technical support, upon request from a Member State, in a broad range of policy domains, which include areas related to public financial and asset management, institutional and administrative reform, judicial reform, business environment, the financial sector and improvement of financial literacy, markets for products, services and labour, education and training, gender equality, sustainable development, public health, social welfare and care, as well as early detection and coordinated response capabilities. Specific emphasis should be placed on actions that foster the green and digital transitions. The instrument should also support preparation for membership of the euro area. (11) This Regulation lays down a financial envelope for the instrument, which is to constitute the prime reference amount, within the meaning of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (6), for the European Parliament and for the Council during the annual budgetary procedure. The annual appropriations should be authorised by the European Parliament and by the Council in the framework of the annual budgetary procedure, within the limits of the Multiannual Financial Framework and taking into account demand for the instrument. (12) In order to cater for additional needs under the instrument, Member States should have the possibility to transfer to the budget of the instrument resources programmed in shared management under Union funds and transfer back uncommitted resources, in accordance with a Regulation laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum and Migration Fund, the Internal Security Fund and the Border Management and Visa Instrument. Transferred resources should be implemented in accordance with the rules of the instrument and should be used exclusively for the benefit of the Member State concerned. The Commission should provide feedback to that Member State on the use of the transferred resources. (13) In order to cater for additional needs under the instrument, a Member State should be able to request additional technical support and should pay for the expenses pertaining to such additional support. Such payments should constitute external assigned revenue in accordance with the Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (7) (the \u2018Financial Regulation\u2019) and should be used exclusively for the benefit of that Member State. (14) Technical support should be provided on request, in order to support the implementation of reforms undertaken at the initiative of Member States, reforms in the context of economic governance processes, in particular those effectively addressing the country-specific recommendations or actions related to the implementation of Union law, and reforms in relation to the implementation of economic adjustment programmes. The instrument should also provide technical support for the preparation, amendment, implementation and revision of recovery and resilience plans pursuant to Regulation (EU) 2021/241. (15) In line with the rules and practice already existing under the Structural Reform Support Programme, a light process for the submission of requests for technical support should be established. For that reason, requests by Member States should be submitted by 31 October unless otherwise specified in the additional dedicated calls for requests. Respecting the overarching principle of equal treatment, sound financial management and transparency, appropriate criteria for the analysis of the requests submitted by Member States should be laid down. Those criteria should be based on the urgency, severity and extent of the problems, as well as on the support needs identified in respect of the policy areas where technical support is envisaged. The Commission should organise additional dedicated calls in response to specific emerging needs of Member States, including, as a matter of priority, for the preparation, amendment, implementation and revision of recovery and resilience plans pursuant to Regulation (EU) 2021/241. (16) Member States should be able, before requesting technical support, to consult, where appropriate, relevant stakeholders, such as local and regional authorities, social partners and civil society in accordance with national law and practices. (17) The content of the cooperation and support plans detailing the measures for the provision of technical support to Members States should also be specified. To that end, the technical support measures envisaged and the related estimated global financial contribution should take into account the actions and activities financed by Union funds or Union programmes. (18) For the purposes of accountability and transparency, and to ensure visibility of the Union action, subject to certain conditions that protect sensitive information, the Commission should transmit the cooperation and support plans simultaneously to the European Parliament and to the Council. The Commission should be able to engage in communication activities. The Commission should publish on its website a list of approved requests for technical support. (19) In order to ensure greater transparency as regards technical input to the national decision-making process, the Commission should establish a single online public repository through which it should be able, subject to applicable rules and on the basis of consultation with the Member States concerned, to make available final studies or reports produced as part of eligible actions. In order to protect sensitive and confidential information related to their public interests, Member States should be able to request, where justified, that the Commission not disclose such documents without their prior agreement. (20) Provisions on the implementation of the instrument should be laid down, in particular the management modes, the forms of funding for the technical support measures and the content of work programmes, which should be adopted by way of implementing acts. In view of the importance of supporting the efforts of national authorities pursuing and implementing reforms, it is necessary to allow for a co-financing rate for grants of up to 100 % of the eligible costs. To allow for the rapid mobilisation of technical support in case of urgency, provision should be made for the adoption of special measures for a limited period. To that effect, a limited amount of the budget within the work programme of the instrument, not exceeding 30 % of the yearly allocation, should be set aside for special measures. (21) In order to ensure the efficient and coherent allocation of funds from the Union budget and to respect the principle of sound financial management, actions under this Regulation should be consistent with and be complementary to ongoing Union programmes. Double funding for the same expenditure should however be avoided. In particular and in order to avoid duplications or overlaps, the Commission and national authorities should ensure, in all stages of the process, effective coordination in order to safeguard consistency, coherence, complementarity and synergy between sources of funding, including the funding of technical assistance. (22) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (8), the instrument should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the instrument on the ground. (23) The Commission should provide an annual report simultaneously to the European Parliament and to the Council on the implementation of this Regulation. In addition, an independent mid-term evaluation, looking at the achievement of the objectives of the instrument, the efficiency of the use of its resources and its added value should be carried out. In that context, the European Parliament should be able to invite the Commission to participate in an exchange of views with the competent committee of the European Parliament to discuss the annual report and the implementation of the instrument. An independent ex post evaluation should, in addition, deal with the long-term impact of the instrument. (24) The work programmes for the implementation of technical support should be established. In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Horizontal financial rules adopted by the European Parliament and by the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation. They determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (25) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (9) and Council Regulations (EC, Euratom) No 2988/95 (10), (Euratom, EC) No 2185/96 (11) and (EU) 2017/1939 (12), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (13). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors, and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (26) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects of the proposed action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (27) This Regulation should not affect the continuation or modification of support measures approved by the Commission by 31 December 2020 on the basis of Regulation (EU) 2017/825 or any other Union act applying to that assistance. Measures approved under Regulation (EU) 2017/825 should therefore remain valid. To that effect, a transitional provision should also be laid down. (28) In order to allow for the prompt application of the measures provided for in this Regulation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes a Technical Support Instrument (the \u2018instrument\u2019). It lays down the general objective and specific objectives of the instrument, the budget of the instrument for the period from 1 January 2021 to 31 December 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018technical support\u2019 means measures that help national authorities to implement institutional, administrative and structural reforms that are sustainable and resilience-enhancing, strengthen economic, social and territorial cohesion and support the public administration in the preparation of sustainable and resilience-enhancing investments; (2) \u2018national authority\u2019 means one or more public authorities at the level of government, including those at regional and local level, as well as Member State organisations within the meaning of point (42) of Article 2 of the Financial Regulation, cooperating in a spirit of partnership in accordance with the Member States\u2019 institutional and legal framework; (3) \u2018Union funds\u2019 means the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund, the European Maritime, Fisheries and Aquaculture Fund, the Asylum and Migration Fund, the Internal Security Fund and the Border Management and Visa Instrument; (4) \u2018international organisation\u2019 means an organisation within the meaning of Article 156 of the Financial Regulation and organisations assimilated to such an organisation pursuant to that Article; (5) \u2018European Semester for economic policy coordination\u2019 or \u2018European Semester\u2019 means the process set out in Article 2-a of Council Regulation (EC) No 1466/97 (14); (6) \u2018country-specific recommendations\u2019 means the Council recommendations addressed to each Member State in accordance with Articles 121(2) and 148(4) TFEU in the context of the European Semester. Article 3 General objective The general objective of the instrument shall be to promote the Union\u2019s economic, social and territorial cohesion by supporting Member States\u2019 efforts to implement reforms. This is necessary to encourage investment, to increase competitiveness and to achieve sustainable economic and social convergence, resilience and recovery. This is also necessary to support Member States\u2019 efforts to strengthen their institutional and administrative capacity, including at regional and local level, to facilitate socially inclusive, green and digital transitions, to effectively address the challenges identified in the country-specific recommendations and to implement Union law. Article 4 Specific objectives To achieve the general objective set out in Article 3, the instrument shall have the specific objectives of assisting national authorities in improving their capacity to: (a) design, develop and implement reforms; (b) prepare, amend, implement and revise recovery and resilience plans pursuant to Regulation (EU) 2021/241. Those specific objectives shall be pursued in close cooperation with the Member States concerned, including through exchange of good practices, processes and methodologies, stakeholder involvement, where appropriate, and a more effective and efficient human resources management. Article 5 Scope The specific objectives set out in Article 4 shall refer to policy areas related to cohesion, competitiveness, education, productivity, research and innovation, smart, fair, sustainable and inclusive growth, jobs and investment, with specific emphasis on actions that foster the digital and just green transitions, and in particular focus on one or more of the following: (a) public financial and asset management, budget process, including green and gender budgeting, macro-fiscal framework, debt and cash management, expenditure and tax policy, tax compliance, revenue administration and customs union, as well as fighting aggressive tax planning, tax fraud, tax evasion and tax avoidance; (b) institutional reform and efficient and service-oriented functioning of public administration and e-government, simplification of rules and procedures, auditing, enhancing capacity to absorb Union funds, promotion of administrative cooperation, effective rule of law, reform of the justice systems, capacity building of competition and antitrust authorities, strengthening of financial supervision and reinforcement of the fight against fraud, corruption and money laundering; (c) business environment, including for small and medium-sized enterprises, the self-employed, entrepreneurs and social economy enterprises, the re-industrialisation and relocation of production to the Union, private sector development, product and service markets, public and private investments including into physical and virtual infrastructure, project promoters and nurseries, public participation in enterprises, privatisation processes, trade and foreign direct investment, competition, efficient and transparent public procurement, sustainable sectoral development, and support for research, innovation and digitisation; (d) education, life-long learning and training, vocational education and training, youth policies, labour market policies, including social dialogue, for the creation of jobs, increased labour market participation of under-represented groups, up- and re-skilling in particular digital skills, media literacy, active citizenship, active ageing, gender equality, civil protection, border and migration policies, the promotion of social inclusion and the fight against poverty, income inequality and all forms of discrimination; (e) accessible, affordable and resilient public healthcare, social security systems, care and welfare, and childcare; (f) policies for the mitigation of climate change, the digital and just green transitions, e-government solutions, e-procurement, connectivity, data access and governance, data protection solutions, e-learning, use of Artificial Intelligence based solutions, the environmental pillar of sustainable development and environmental protection, climate action, transport and mobility, promoting the circular economy, energy and resource efficiency and renewable energy sources, achieving energy diversification, tackling energy poverty and ensuring energy security, and for the agricultural sector, soil and biodiversity protection, fisheries and the sustainable development of rural, remote and insular areas; (g) financial sector policies and regulation, including financial literacy, financial stability, access to finance and lending to the real economy, in particular for small and medium-sized enterprises, the self-employed and entrepreneurs; (h) the production, provision and quality monitoring of data and statistics; (i) preparation for membership of the euro area; and (j) early detection of and a coordinated response to substantial public health or security risks, as well as ensuring business and service continuity for essential public and private institutions and sectors. Article 6 Budget 1. The financial envelope for the implementation of the instrument for the period from 1 January 2021 to 31 December 2027 shall be EUR 864 000 000 in current prices. 2. The financial envelope for the instrument may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities which are required for the management of the instrument and the achievement of its objectives, in particular studies, meetings of experts, information and communication actions, including corporate communication of the political priorities of the Union, in so far as they are related to the objectives of this Regulation, expenses linked to IT networks focusing on information processing and exchange, including corporate information technology tools, and all other technical and administrative assistance expenses incurred by the Commission for the management of the instrument. Expenses may also cover the costs of other supporting activities such as quality control and monitoring of technical support projects on the ground and the costs of peer counselling and experts for the assessment and implementation of structural reforms. 3. In addition to the financial envelope set out in paragraph 1, resources allocated to Member States under shared management may, at their request, and in accordance with the conditions and the procedure set out in a Regulation laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum and Migration Fund, the Internal Security Fund and the Border Management and Visa Instrument, be transferred to the instrument for the purpose of financing clearly identified technical support requests, and transferred back if not committed. Those resources shall be used exclusively for the benefit of the Member State that requested the transfer, including at regional and local level. Article 7 Payments for additional technical support 1. In addition to the technical support covered by the budget set out in Article 6, Member States may request additional technical support under the instrument and shall pay for the expenses pertaining to such additional support. 2. The payments made by a Member State on the basis of paragraph 1 of this Article shall constitute external assigned revenue provided by the basic act in accordance with Article 21(5) of the Financial Regulation and shall be used exclusively for the benefit of that Member State. CHAPTER II TECHNICAL SUPPORT Article 8 Eligible actions for technical support To pursue the objectives set out in Articles 3 and 4, the instrument shall finance, in particular, the following types of action: (a) the provision of expertise related to policy advice, policy change, formulation of strategies and reform roadmaps, as well as to legislative, institutional, structural and administrative reforms; (b) the short-term or long-term provision of experts, including resident experts, to perform tasks in specific domains or to carry out operational activities, where necessary with interpretation, translation and cooperation support, administrative assistance and infrastructure and equipment facilities; (c) institutional, administrative or sectoral capacity building and related supporting actions at all governance levels, also contributing to the empowerment of civil society, including social partners, as appropriate, in particular: (i) seminars, conferences and workshops, with, where appropriate, stakeholder involvement; (ii) exchanges of best practices, including, where appropriate, working visits to relevant Member States or third countries to enable officials to acquire or increase their expertise or knowledge in relevant matters; (iii) training actions and the development of online or other training modules to support the necessary professional skills and knowledge relating to the relevant reforms; (d) the collection of data and statistics, development of common methodologies, including on gender and climate mainstreaming and tracking, and, where appropriate, indicators or benchmarks; (e) the organisation of local operational support in areas such as asylum, migration and border control; (f) IT capacity building, including expertise related to development, maintenance, operation and quality control of the IT infrastructure and applications needed to implement the relevant reforms, cybersecurity, open source software and hardware solutions, data protection solutions as well as expertise related to programmes geared towards the digitalisation of public services, in particular in services such as healthcare, education or the judiciary; (g) the carrying out of studies, including feasibility studies, research, analyses and surveys, evaluations and impact assessments, including gender impact assessments, and the development and publication of guides, reports and educational material; (h) the establishment and execution of communication projects and strategies for learning including e-learning, cooperation, awareness raising, dissemination activities and exchange of good practices, organisation of awareness-raising and information campaigns, media campaigns and events, including corporate communication and, where appropriate, communication through social networks or platforms; (i) the compilation and publication of materials to disseminate information and the results of technical support provided under the instrument, including through the development, operation and maintenance of systems and tools using information and communication technologies; and (j) any other relevant activity in support of the general objective and specific objectives set out in Articles 3 and 4 respectively. Article 9 Request for technical support 1. Member States wishing to receive technical support under the instrument shall submit a request for technical support to the Commission, identifying the policy areas and the priorities for support within the scope as set out in Article 5. Such requests shall be submitted by 31 October unless otherwise specified in the additional dedicated calls for requests referred to in paragraph 4 of this Article. The Commission may provide guidance on the main elements to be included in the request for technical support. 2. In order for the reforms pursued by Member States to gather wide support and ownership, Member States wishing to receive technical support under the instrument may consult, where appropriate, relevant stakeholders before requesting technical support, in accordance with national law and practices. 3. Members States may submit a request for technical support in circumstances linked to: (a) the implementation of reforms by Member States, undertaken on their own initiative and in accordance with the general objective and specific objectives set out in Articles 3 and 4 respectively; (b) the implementation of growth-sustaining and resilience-enhancing reforms in the context of economic governance processes, in particular the country-specific recommendations issued in the context of the European Semester or actions related to the implementation of Union law; (c) the implementation of economic adjustment programmes for Member States that receive Union financial assistance under existing instruments, in particular in accordance with Regulation (EU) No 472/2013 of the European Parliament and of the Council (15) as regards the Member States whose currency is the euro and Council Regulation (EC) No 332/2002 (16) as regards Member States whose currency is not the euro; (d) the preparation, amendment and revision of recovery and resilience plans pursuant to Regulation (EU) 2021/241 and the implementation thereof undertaken by Member States. 4. The Commission shall organise additional dedicated calls for requests in response to specific emerging needs of Member States, such as for the submission of requests linked to the circumstances referred to in point (d) of paragraph 3. 5. Taking into account the principles of transparency, equal treatment and sound financial management and further to a dialogue with the Member States, including in the context of the European Semester, the Commission shall analyse the request for support referred to in paragraph 1 based on the urgency, breadth and depth of the challenges identified, support needs in respect of the policy areas concerned, analysis of socioeconomic indicators and institutional and general administrative capacity of the Member States concerned. Based on that analysis and taking into account the existing actions and measures financed by Union funds or other Union programmes, the Commission and the Member States concerned shall agree on the priority areas for support, the objectives, an indicative timeline, the scope of the support measures to be provided and the estimated global financial contribution for such technical support, which shall be set out in a cooperation and support plan (the \u2018cooperation and support plan\u2019). 6. The cooperation and support plan shall identify, separately from other technical support, the measures linked to the recovery and resilience plans for Member States pursuant to Regulation (EU) 2021/241. Article 10 Information to the European Parliament and to the Council and communication regarding cooperation and support plans 1. The Commission shall transmit, with the consent of the Member State concerned, the cooperation and support plan simultaneously to the European Parliament and to the Council without undue delay. The Member State concerned may refuse to give such consent in the case of sensitive or confidential information the disclosure of which would jeopardise public interests of the Member State. 2. Notwithstanding paragraph 1, the Commission shall transmit the cooperation and support plan to the European Parliament and to the Council: (a) as soon as the Member State concerned has redacted all sensitive or confidential information, the disclosure of which would jeopardise the public interests of the Member State; (b) after a reasonable period, when the disclosure of relevant information would not adversely affect the implementation of the support measures, and in any case no later than two months after the implementation of such measures under the cooperation and support plan. 3. The Commission may engage in communication activities to ensure the visibility of Union funding for support measures envisaged in the cooperation and support plans, including through joint communication activities with the national authorities and the representation offices of the European Parliament and of the Commission in the Member State concerned. The Commission shall publish on its website a list of approved requests for technical support and shall regularly update that list. The Commission shall regularly inform the representation offices of the European Parliament and of the Commission of projects in the Member States concerned. Article 11 Complementary funding Actions financed under the instrument may receive support from other Union programmes, instruments or funds under the Union budget provided that such support does not cover the same costs. Article 12 Implementation of the instrument 1. The Commission shall implement the instrument in accordance with the Financial Regulation. 2. The measures under the instrument may be implemented either directly by the Commission or, indirectly, by persons or entities in accordance with Article 62(1) of the Financial Regulation. In particular, Union support for actions pursuant to Article 8 of this Regulation shall take the form of: (a) grants; (b) public procurement contracts; (c) reimbursement of costs incurred by external experts, including experts from the national, regional or local authorities of Member States providing or receiving support; (d) contributions to trust funds set up by international organisations; and (e) actions carried out through indirect management. 3. Grants may be awarded to the national authorities, the European Investment Bank group, international organisations, public or private bodies and entities legally established in: (a) Member States; (b) European Free Trade Association countries which are party to the European Economic Area Agreement, in accordance with the conditions laid down therein. The co-financing rate for grants shall be up to 100 % of the eligible costs. 4. Technical support may be provided with the cooperation of other Member State entities and international organisations. 5. Technical support may also be provided by individual experts, who may be invited to contribute to selected activities organised wherever that is necessary for the achievement of the specific objectives set out in Article 4. 6. In order to implement the technical support, the Commission shall adopt work programmes by way of implementing acts and inform the European Parliament and the Council thereof. Work programmes shall set out: (a) the allocation for the instrument; (b) the measures referred to in paragraph 2 of this Article, in accordance with the general objective and specific objectives referred to in Articles 3 and 4 of this Regulation, respectively, and within the scope referred to in Article 5 and eligible actions set out in Article 8 of this Regulation; and (c) the selection and award criteria for grants and all the elements required by the Financial Regulation. 7. To ensure the timely availability of resources, a limited part of the work programme, not exceeding 30 % of the yearly allocation, shall be reserved for special measures in the event of unforeseen and duly justified grounds of urgency requiring an immediate response, including a serious disturbance in the economy or significant circumstances seriously affecting the economic, social or health conditions pertaining in a Member State and going beyond its control. The Commission may, on request from a Member State wishing to receive technical support, adopt special measures in accordance with the objectives and actions set out in this Regulation to provide technical support to national authorities in addressing urgent needs. Such special measures shall be interim in nature and shall be linked to the circumstances laid down in Article 9(3). Such special measures shall end within six months of their adoption and may be replaced by technical support in accordance with the conditions set out in Article 9. CHAPTER III COMPLEMENTARITY, MONITORING AND EVALUATION Article 13 Coordination and complementarity 1. The Commission and the Member States concerned shall, commensurate to their respective responsibilities, foster synergies and ensure effective coordination between the instrument and other Union programmes and instruments, and in particular with measures financed by the Union funds. For that purpose, they shall: (a) ensure complementarity, synergy, coherence and consistency among different instruments at Union, national and, where appropriate, regional and local level, in particular in relation to measures financed by Union funds, both in the planning phase and during implementation; (b) optimise mechanisms for coordination in order to avoid duplication of effort or overlaps; (c) ensure close cooperation between those responsible for implementation at Union, national and, where appropriate, regional and local level to deliver coherent and streamlined support actions under the instrument. 2. The Commission shall endeavour to ensure complementarity and synergies with support provided by other relevant international organisations. Article 14 Monitoring of implementation 1. The Commission shall monitor the implementation of the instrument and measure the achievement of the general objective and specific objectives set out in Articles 3 and 4 respectively, including by making use of the cooperation and support plans. Indicators to be used for reporting on progress and for the purpose of monitoring and evaluation of this Regulation towards the achievement of the general objective and specific objectives are set in the Annex. The monitoring of implementation shall be targeted and proportionate to the activities carried out under the instrument. 2. The performance reporting system shall ensure that data for monitoring the implementation of the instrument and results are collected in an efficient, effective and timely manner and, where relevant and feasible, in a gender-disaggregated form. To that end, proportionate reporting requirements shall be imposed on recipients of Union funding. Article 15 Annual report 1. The Commission shall provide an annual report simultaneously to the European Parliament and to the Council on the implementation of this Regulation (the \u2018annual report\u2019). 2. The annual report shall include information on: (a) requests for support submitted by Member States pursuant to Article 9(1); (b) the analysis of the application of the criteria referred to in Article 9(3), used to analyse the requests for support submitted by Member States; (c) cooperation and support plans as referred to in Article 9(5); (d) special measures adopted pursuant to Article 12(7); (e) the implementation of support measures, where appropriate also at national and regional level; and (f) the communication activities carried out by the Commission. 3. The European Parliament may invite the Commission to participate in an exchange of views with the competent committee of the European Parliament to discuss the annual report and the implementation of the instrument. Article 16 Mid-term evaluation and ex post evaluation 1. By 20 February 2025, the Commission shall provide simultaneously to the European Parliament and the Council, as well as to the European Economic and Social Committee and the Committee of the Regions, an independent mid-term evaluation report on the implementation of this Regulation. That report shall, in particular, assess the extent to which the general objective and specific objectives referred to in Articles 3 and 4, respectively, have been achieved, the adequacy and the efficiency of the use of resources and the European added value. It shall also consider the continued relevance of all objectives and actions. Where appropriate, the results of the mid-term evaluation report may be used for any relevant legislative proposals. 2. By 31 December 2030, the Commission shall provide simultaneously to the European Parliament and the Council, as well as to the European Economic and Social Committee and the Committee of the Regions, an independent ex post evaluation report. That report shall consist of a global assessment of the implementation of this Regulation and shall include information on the impact of this Regulation in the long-term. Article 17 Transparency The Commission shall establish a single online public repository through which it may, subject to applicable rules and on the basis of consultation with the Member States concerned, make available final studies or reports produced as part of eligible actions set out in Article 8. Where justified, the Member States concerned may request that the Commission not disclose such documents without their prior agreement. CHAPTER IV TRANSITIONAL AND FINAL PROVISIONS Article 18 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the instrument, to actions taken pursuant to the instrument and to the results obtained, including, where appropriate and with the agreement of the national authorities, through joint communication activities with the national authorities and the representation offices of the European Parliament and of the Commission in the Member State concerned. Article 19 Transitional provisions 1. Technical support actions and activities initiated on or before 31 December 2020 pursuant to Regulation (EU) 2017/825 shall continue to be governed by that Regulation until their completion. 2. The financial envelope set out in Article 6(1) of this Regulation may also cover technical and administrative assistance expenses, including monitoring, communication and evaluation required pursuant to Regulation (EU) 2017/825 and not completed by 31 December 2020. 3. If necessary, appropriations may be entered in the budget beyond 2020 to cover the expenses provided for in Article 6(2) of this Regulation relating to the management of actions and activities initiated under Regulation (EU) 2017/825 and not completed by 31 December 2020. Article 20 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 10 February 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 364, 28.10.2020, p. 132. (2) OJ C 440, 18.12.2020, p. 160. (3) Position of the European Parliament of 19 January 2021 (not yet published in the Official Journal) and decision of the Council of 2 February 2021. (4) Regulation (EU) 2017/825 of the European Parliament and of the Council of 17 May 2017 on the establishment of the Structural Reform Support Programme for the period 2017 to 2020 and amending Regulations (EU) No 1303/2013 and (EU) No 1305/2013 (OJ L 129, 19.5.2017, p. 1). (5) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (see page 17 of this Official Journal). (6) OJ L 433 I, 22.12.2020, p. 28. (7) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (8) OJ L 123, 12.5.2016, p. 1. (9) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (10) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (11) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (12) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (13) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (14) Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (OJ L 209, 2.8.1997, p. 1). (15) Regulation (EU) No 472/2013 of the European Parliament and of the Council of 21 May 2013 on the strengthening of economic and budgetary surveillance of Member States in the euro area experiencing or threatened with serious difficulties with respect to their financial stability (OJ L 140, 27.5.2013, p. 1). (16) Council Regulation (EC) No 332/2002 of 18 February 2002 establishing a facility providing medium-term financial assistance for Member States\u2019 balances of payments (OJ L 53, 23.2.2002, p. 1). ANNEX INDICATORS The achievement of the general objective and specific objectives referred to in Articles 3 and 4, respectively, shall be measured on the basis of the following indicators to be broken down by Member State and by area of intervention. Indicators shall be used in accordance with data and information available, including quantitative and/or qualitative data. Output indicators (a) number of cooperation and support plans concluded (b) number of technical support activities carried out (c) deliverables provided by the technical support activities such as action plans, roadmaps, guidelines, handbooks and recommendations Result indicators (d) outcomes of the technical support activities provided, such as the adoption of a strategy, the adoption of a new law/act or the modification of an existing one and the adoption of new procedures and actions to enhance the implementation of reforms Impact indicators (e) the objectives set in the cooperation and support plans which have been achieved due, inter alia, to the technical support received The Commission shall also carry out the ex post evaluation referred to in Article 16 with the purpose of establishing the links between the technical support provided and the implementation of the relevant measures in the Member State concerned with a view to enhancing resilience, sustainable growth, jobs and cohesion.", "summary": "EU Technical Support Instrument (2021-2027) EU Technical Support Instrument (2021-2027) SUMMARY OF: Regulation (EU) 2021/240 establishing a Technical Support Instrument WHAT IS THE AIM OF THE REGULATION? It aims to ensure that the European Commission can continue to provide tailor-made expertise on the ground and support EU Member States in improving their institutional and administrative capacity to develop and implement reforms. KEY POINTS The Technical Support Instrument (TSI) builds upon the current Structural Reform Support Programme (SRSP) set up by Regulation (EU) 2017/825 (see summary). The TSI contributes to the implementation of the European Green Deal (see summary) and supports Member States\u2019 efforts to implement policy objectives to facilitate socially inclusive, green and digital transitions, in accordance with: the Paris Agreement on climate change;the EU\u2019s 2030 climate and energy targets and the 2050 climate neutrality target;the United Nations Sustainable Development Goals;the European Pillar of Social Rights. Objectives To promote the EU\u2019s economic, social and territorial cohesion by helping Member States implement reforms, the regulation aims to assist national authorities in improving their capacity to: design, develop and implement reforms; prepare, amend, implement and revise recovery and resilience plans pursuant to Regulation (EU) 2021/241 which sets out the Recovery and Resilience Facility (see summary). Scope The specific objectives refer to a number of policy areas with specific emphasis on actions that foster the digital, just and green transitions. These include: public financial and asset management, budget process, including green and gender budgeting, macro-fiscal framework, debt and cash management, expenditure and tax policy; institutional reform, simplification of rules and procedures, reform of the justice systems, strengthening financial supervision and reinforcement of the fight against fraud, corruption and money laundering; business environment, the re-industrialisation and relocation of production to the EU, sustainable sectoral development, and support for research, innovation and digitisation; education, life-long learning and training, vocational education and training, youth policies, labour market policies, up- and re-skilling in particular digital skills, media literacy, social inclusion and the fight against poverty, income inequality and all forms of discrimination; accessible, affordable and resilient public healthcare, social security systems, care and welfare, and childcare; policies for the mitigation of climate change, digital, just and green transitions, e-learning, use of artificial intelligence, transport and mobility, tackling energy poverty and ensuring energy security, soil and biodiversity protection, fisheries and the sustainable development of rural, remote and insular areas; financial sector policies and regulation, including financial literacy, financial stability, access to finance and lending to the real economy, in particular for small and medium-sized enterprises, the self-employed and entrepreneurs; the production, provision and quality monitoring of data and statistics; preparation for membership of the euro area; early detection of and a coordinated response to substantial public health or security risks, as well as ensuring business and service continuity for essential public and private institutions and sectors. Technical support To achieve the regulation\u2019s objectives, the instrument will finance a number of types of actions including but not limited to: providing expertise related to policy advice, policy change, formulation of strategies and reform roadmaps, as well as to legislative, institutional, structural and administrative reforms; providing experts on a short-term or long-term basis, including resident experts, to perform tasks in specific domains or to carry out operational activities; institutional, administrative or sectoral capacity building and and related supporting actions at all governance levels, also contributing to the empowerment of civil society organisations; organising local operational support in areas such as asylum, migration and border control; carrying out studies, including feasibility studies, research, analyses and surveys, evaluations and impact assessments. Member States wishing to receive technical support shall submit a request for technical support to the Commission, identifying policy areas and priorities. Budget The budget for the instrument for the period 1 January 2021 - 31 December 2027 is \u20ac864 million in current prices. Member States can transfer additional resources to the budget of the instrument to finance actions eligible for technical support which would be used exclusively for the benefit of the Member State concerned. FROM WHEN DOES THE REGULATION APPLY? It has applied since 19 February 2021. BACKGROUND Technical Support Instrument (European Commission). MAIN DOCUMENT Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (OJ L 57, 18.2.2021, pp. 1-16) RELATED DOCUMENTS Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, pp. 17-75) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222) last update 05.05.2021"}
{"article": "17.5.2021 EN Official Journal of the European Union L 172/1 REGULATION (EU) 2021/782 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2021 on rail passengers\u2019 rights and obligations (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) A number of amendments are to be made to Regulation (EC) No 1371/2007 of the European Parliament and of the Council (3) in order to enhance protection for passengers and to encourage an increase in rail travel, whilst having due regard in particular to Articles 11, 12 and 14 of the Treaty on the Functioning of the European Union (TFEU). In view of those amendments and in the interests of clarity, Regulation (EC) No 1371/2007 should therefore be recast. (2) In the framework of the common transport policy, it is important to safeguard users\u2019 rights for rail passengers and to improve the quality and effectiveness of rail passenger services in order to help increase the share of rail transport in relation to other modes of transport. (3) Despite considerable progress having been made in protecting consumers in the Union, further improvements to the protection of rail passengers\u2019 rights still need to be made. (4) In particular, since the rail passenger is the weaker party to the transport contract, rail passengers\u2019 rights should be safeguarded. (5) Granting the same rights to rail passengers taking international and domestic journeys seeks to raise the level of consumer protection in the Union, to ensure a level playing field for railway undertakings and to guarantee a uniform level of passengers\u2019 rights. Passengers should receive as precise information as possible on their rights. As certain modern formats of tickets do not physically allow information to be printed on them, it should be possible to provide the information required by this Regulation by other means. (6) Rail services offered strictly for historic or touristic use do not usually serve normal transport needs. Such services are usually isolated from the rest of the Union rail system and use technology that may limit their accessibility. With the exception of certain provisions which should apply to all rail passenger services throughout the Union, Member States should be able to grant exemptions from the application of the provisions of this Regulation to rail services offered strictly for historic or touristic use. (7) Urban, suburban and regional rail passenger services are different in character from long-distance rail passenger services. Member States should therefore be allowed to exempt such services from certain provisions of this Regulation on passengers\u2019 rights. Such exemptions should however not apply to essential rules, in particular not to those provisions relating to non-discriminatory conditions of transport contracts, to the right to purchase rail tickets without undue difficulty, to the railway undertakings\u2019 liability in respect of passengers and their luggage, to the requirement that railway undertakings be adequately insured and to the requirement that adequate measures be taken to ensure passengers\u2019 personal security in railway stations and on trains. Regional services are more integrated in the rest of the Union rail system and the journeys concerned are longer. For regional rail passenger services, possible exemptions should therefore be restricted even further. As regards regional rail passenger services, exemptions to the provisions of this Regulation that facilitate the use of rail services by persons with disabilities or persons with reduced mobility should be completely phased out, and exemptions should not apply as regards provisions of this Regulation promoting the use of bicycles. In addition, the possibility to exempt regional services from certain obligations as regards the provision of through-tickets and re-routing should be limited in time. (8) It is an aim of this Regulation to improve rail passenger services within the Union. Therefore, Member States should be able to grant exemptions for services in regions where a significant part of the service is operated outside the Union. (9) Furthermore, to allow a smooth transition from the framework established pursuant to Regulation (EC) No 1371/2007 to the one under this Regulation, earlier national exemptions should be phased out gradually to ensure the necessary legal certainty and continuity. Member States which currently have in place exemptions pursuant to Article 2(4) of Regulation (EC) No 1371/2007 should be allowed to exempt domestic rail passenger services only from the provisions of this Regulation that require significant adaptation and, in any event, only for a limited period in time. Member States should also be allowed, for a transitional period, to grant an exemption from the obligation to distribute traffic and travel information among operators, but only where it is not technically feasible for the infrastructure manager to provide real-time data to any railway undertaking, ticket vendor, tour operator or station manager. An assessment of what is technically feasible should be made at least every two years. (10) Member States should inform the Commission when they exempt rail passenger services from the application of certain provisions of this Regulation. When providing this information, Member States should explain the reasons for granting such exemptions and the measures taken or envisaged to comply with the obligations under this Regulation when the exemptions concerned expire. (11) Where there are several station managers responsible for one station, Member States should have the possibility to designate the body tasked with the responsibilities referred to in this Regulation. (12) Access to real-time travel information, including that on tariffs, makes rail travel more accessible to new customers and provides them with a wider range of journey possibilities and tariffs to choose from. Railway undertakings should provide other railway undertakings, ticket vendors and tour operators that sell their services with access to such travel information and give them the possibility to make and cancel reservations in order to facilitate rail travel. Infrastructure managers should distribute real-time data relating to the arrival and the departure of trains to railway undertaking and station managers, as well as to ticket vendors and tour operators in order to facilitate rail travel. (13) More detailed requirements regarding the provision of travel information are set out in the technical specifications for interoperability referred to in Commission Regulation (EU) No 454/2011 (4). (14) Strengthening of the rights of rail passengers should build on the existing international law contained in Appendix A \u2013 Uniform rules concerning the Contract for International Carriage of Passengers and Luggage by Rail (CIV) \u2013 to the Convention concerning International Carriage by Rail (COTIF) of 9 May 1980, as modified by the Protocol for the modification of the Convention concerning International Carriage by Rail of 3 June 1999 (1999 Protocol). However, it is desirable to extend the scope of this Regulation and protect not only international passengers but domestic passengers too. On 23 February 2013, the Union acceded to the COTIF. (15) Member States should prohibit discrimination on the basis of the nationality of the passenger or the place of establishment within the Union of the railway undertaking, ticket vendor or tour operator. However, social tariffs and the encouragement of wider use of public transport should not be prohibited, provided that such measures are proportionate and independent of the nationality of the passenger concerned. Railway undertakings, ticket vendors and tour operators are free to determine their commercial practices, including the use of special offers and the promotion of certain sales channels. In light of the development of online platforms selling passenger transport tickets, Member States should pay special attention to ensuring that no discrimination occurs during the process of accessing online interfaces or purchasing tickets. Furthermore, regardless of how a certain type of a ticket is purchased, the level of protection of the passenger should be the same. (16) The increasing popularity of cycling across the Union has implications for overall mobility and tourism. An increase in the use of both railways and cycling in the modal split reduces the environmental impact of transport. Therefore, railway undertakings should facilitate the combination of cycling and train journeys as much as possible. In particular, when acquiring new rolling stock or making a major upgrade to existing rolling stock, they should provide an adequate number of places for bicycles unless the acquisition or upgrade concerns restaurant cars, sleeping cars or couchette cars. In order to avoid a negative impact on the safety performance of the existing rolling stock, that obligation should only apply in cases of a major upgrade requiring a new vehicle authorisation for placement on the market. (17) The adequate number of bicycle places for a train composition should be determined taking into consideration the size of train composition, the type of service and the demand for transport of bicycles. Railway undertakings should have the possibility to establish plans with concrete numbers of bicycle places for their services, after consulting the public. Where railway undertakings choose not to establish plans, a statutory number should apply. That statutory number should also serve as guidance by railway undertakings when establishing their plans. A number which is below the statutory number should be considered adequate only where it is justified by special circumstances such as operation of rail services in winter time where there is clearly no or low demand for the transport of bicycles. Furthermore, in some Member States demand for the transport of bicycles is particularly high as regards certain types of services. Therefore, Member States should have the possibility to determine the minimum adequate numbers of bicycle places for certain types of services. These numbers should prevail over the concrete numbers as mentioned in any plans of the railway undertakings. This should not impede the free movement of railway rolling stock within the Union. Passengers should be informed of the space available for bicycles. (18) The rights and obligations regarding carriage of bicycles on trains should apply to bicycles that can be readily ridden prior to and after the rail journey. Carriage of bicycles in packages and bags, as applicable, is covered by the provisions of this Regulation relating to luggage. (19) Rail passengers\u2019 rights to rail services include the receipt of information regarding the service both before and during the journey. Railway undertakings, ticket vendors and tour operators should provide general information on the rail service in advance of travel. That information should be provided in accessible formats for persons with disabilities or persons with reduced mobility. Railway undertakings and, where possible, ticket vendors and tour operators should provide the passenger during the journey with further information required by this Regulation. Where a station manager has such information, he or she should also provide the information to the passengers. (20) The size of ticket vendors varies substantially from micro to large enterprises and some ticket vendors offer their services only offline or only online. The obligation to provide travel information to passengers should therefore be proportional to the different sizes, and therefore the different capacities, of the ticket vendors. (21) This Regulation should not prevent railway undertakings, tour operators or ticket vendors from offering to passengers more favourable conditions than those laid down in this Regulation. However, this Regulation should not lead to a railway undertaking being bound by more favourable contractual conditions offered by a tour operator or ticket vendor, unless an arrangement between the railway undertaking and the tour operator or the ticket vendor provides otherwise. (22) Through-tickets allow seamless journeys for passengers and therefore all reasonable efforts should be made to offer such tickets for long-distance, urban, suburban and regional rail passenger services, whether international or domestic, including rail passenger services exempted under this Regulation. It should be possible, for the purpose of determining the total delay for which compensation is available, to exclude periods of delay that occurred during the parts of the journey relating to rail services exempted under this Regulation. (23) Regarding services operated by the same railway undertaking, the transfer of rail passengers from one service to another should be facilitated by the introduction of an obligation to provide through-tickets, since no commercial agreements between railway undertakings are needed. The requirement to provide through-tickets should also apply to services operated by railway undertakings belonging to the same owner or which are wholly-owned subsidiaries of one of the railway undertakings providing rail services comprised in the journey. The railway undertaking should have the possibility to specify on the through-ticket the time of departure of each rail service, including regional services, for which the through-ticket is valid. (24) Passengers should be clearly informed whether tickets sold by a railway undertaking in a single commercial transaction constitute a through-ticket. Where passengers are not correctly informed, the railway undertaking should be liable as if those tickets were a through-ticket. (25) The offer of through-tickets should be promoted. However, correct information concerning the rail service is essential also when passengers buy tickets from a ticket vendor or a tour operator. Where the ticket vendors or the tour operators sell separate tickets as a bundle, they should clearly inform the passenger that those tickets do not offer the same level of protection as through-tickets and that those tickets have not been issued as through-tickets by the railway undertaking or railway undertakings providing the service. Where ticket vendors or tour operators fail to comply with this requirement, their liability should go beyond the reimbursement of the tickets. (26) When offering through-tickets, it is important that the railway undertakings take into account realistic and applicable minimum connection times when originally booked, as well as any relevant factors such as the size and location of the respective stations and platforms. (27) In light of the United Nations Convention on the Rights of Persons with Disabilities and in order to give persons with disabilities and persons with reduced mobility opportunities for rail travel comparable to those of other citizens, rules for non-discrimination and assistance during their journey should be established. Persons with disabilities and persons with reduced mobility have the same rights as all other citizens to free movement and to non-discrimination. Inter alia, special attention should be given to the provision of information to persons with disabilities and persons with reduced mobility concerning the accessibility of rail services, access conditions of rolling stock and the facilities on board. In order to provide passengers with sensory impairment with the best information on delays, visual and audible systems should be used, as appropriate. Persons with disabilities should be enabled to buy tickets on board a train without extra charges where there is no accessible means to buy a ticket prior to boarding the train. However, there should be a possibility to limit this right in circumstances relating to security or compulsory train reservation. Staff should be adequately trained to respond to the needs of persons with disabilities and persons with reduced mobility, in particular when providing assistance. To ensure equal travel conditions, assistance should be provided to such persons at stations and on board or, in the absence of trained accompanying staff on board the train and at the station, all reasonable efforts should be taken to allow access to travel by rail. (28) Railway undertakings and station managers should actively cooperate with organisations representing people with disabilities in order to improve the quality of accessibility of transport services. (29) In order to facilitate access to rail passenger services for persons with disabilities and persons with reduced mobility, Member States should have the possibility to require railway undertakings and station managers to set up national Single Points of Contact to coordinate information and assistance. (30) In order to ensure that assistance to persons with disabilities and persons with reduced mobility is provided, for practical reasons it is necessary to notify the railway undertaking, the station manager, the ticket vendor or the tour operator in advance of the need for assistance. While this Regulation establishes a common maximum time period for such pre-notifications, voluntary arrangements providing for shorter periods are valuable where they improve the mobility of persons with disabilities and persons with reduced mobility. To guarantee the widest possible distribution of information concerning such reduced time periods, it is important that the Commission includes in its report on the implementation and results of this Regulation information on the development of reduced pre-notification arrangements and related dissemination of information. (31) Railway undertakings and station managers should take into account the needs of persons with disabilities and persons with reduced mobility, through compliance with Directive (EU) 2019/882 of the European Parliament and of the Council (5) and Commission Regulation (EU) No 1300/2014 (6). Where this Regulation refers to provisions of Directive (EU) 2019/882, those provisions should be applied by the Member States from 28 June 2025 and in accordance with the transitional measures laid down in Article 32 of that Directive. With regard to rail passenger services, the scope of those provisions is set out in point (c) of Article 2(2) of that Directive. (32) Certain animals are trained to assist persons with disabilities to enable them to be independently mobile. For such mobility it is essential that those animals can be taken on board trains. This Regulation establishes common rights and obligations as regards assistance dogs. However, Member States should have the possibility to conduct trials using other mobility assistance animals and to allow them on board trains in their domestic rail services. It is important that the Commission monitors the development regarding this matter in view of future work on mobility assistance animals. (33) It is desirable that this Regulation creates a system of compensation for passengers in the case of delay, including in cases where the delay is caused by a cancellation of a service or a missed connection. In the event of a delay of a rail passenger service, railway undertakings should provide passengers with compensation based on a percentage of the ticket price. (34) Railway undertakings should be obliged to be insured, or to have adequate guarantees, for their liability to rail passengers in the event of accident. (35) Strengthened rights of compensation and assistance in the event of delay, missed connection or cancellation of a service should lead to greater incentives for the rail passenger market, to the benefit of passengers. (36) In the event of delay, passengers should be provided with continued or re-routed transport options under comparable transport conditions. The needs of persons with disabilities and persons with reduced mobility should be taken into account in such an event. (37) However, a railway undertaking should not be obliged to pay compensation if it can prove that the delay was caused by extraordinary circumstances such as extreme weather conditions or major natural disasters endangering the safe operation of the service. Any such event should have the character of an exceptional natural catastrophe, as distinct from normal seasonal weather conditions such as autumnal storms or regularly-occurring urban flooding caused by tides or snowmelt. In addition, a railway undertaking should not be obliged to pay compensation if it can prove that the delay was caused by a major public health crisis, such as a pandemic. Furthermore, where the delay is caused by the passenger or by certain acts of third parties, the railway undertaking should not be obliged to provide compensation for the delay. Railway undertakings should prove that they could neither foresee nor avoid such events, nor could they prevent the delay, even if all reasonable measures had been taken, including appropriate preventive maintenance of their rolling stock. Strikes by the personnel of the railway undertaking, and actions or omissions by other railway operators using the same infrastructure, infrastructure manager or station manager, should not affect the liability for delays. The circumstances in which railway undertakings are not obliged to pay compensation should be objectively justified. Where a communication or a document of the railway infrastructure manager, a public authority or other body independent from the railway undertakings, indicating the circumstances on which the railway undertaking relies in order to be exempt from the obligation to pay compensation, is available to railway undertakings, they should bring such communications or documents to the attention of passengers and, where relevant, to that of the authorities concerned. (38) Railway undertakings should be encouraged to simplify the procedure for passengers to apply for compensation or reimbursement. In particular, Member States should have the possibility to require that railway undertakings accept applications by certain means of communication, such as on websites or by using mobile applications, provided that such requirements are not discriminatory. (39) In order to make it easier for passengers to request reimbursement or compensation in accordance with this Regulation, forms that are valid throughout the Union should be established for such requests. Passengers should have the possibility to submit their requests by using such a form. (40) In cooperation with infrastructure managers and station managers, railway undertakings should prepare contingency plans to minimise the impact of major disruptions by providing stranded passengers with adequate information and care. (41) It is also desirable to relieve accident victims and their dependants of short-term financial concerns in the period immediately after an accident. (42) It is in the interests of rail passengers that adequate measures be taken, in agreement with public authorities, to ensure their personal security at stations as well as on board trains. (43) Rail passengers should be able to submit a complaint to any railway undertaking involved, to the station managers of certain stations or, where appropriate, to ticket vendors and tour operators regarding their respective fields of responsibilities on the rights and obligations conferred by this Regulation. Rail passengers should be entitled to receive a response within a reasonable period of time. (44) In the interest of efficient handling of complaints, railway undertakings and station managers should have the right to establish joint customer services and complaint-handling mechanisms. Information on the complaint-handling procedures should be publicly available and easily accessible to all passengers. (45) This Regulation should not affect the rights of passengers to file a complaint with a national body or to seek legal redress through national procedures. (46) Railway undertakings and station managers should define, manage and monitor service quality standards for rail passenger services. Railway undertakings should also make information on their service quality performance publicly available. (47) In order to maintain a high level of consumer protection in rail transport, Member States should be required to designate national enforcement bodies to monitor closely the application of this Regulation and to enforce it at national level. Those bodies should be able to take a variety of enforcement measures. Passengers should be able to complain to those bodies about alleged infringements of the Regulation. To ensure the satisfactory handling of such complaints, the bodies should also cooperate with the national enforcement bodies of other Member States. (48) Member States which have no railway system, and no immediate prospect of having one, would bear a disproportionate and pointless burden if they were subject to the enforcement obligations as regards station managers and infrastructure managers provided for by this Regulation. The same applies to enforcement obligations as regards railway undertakings for as long as a Member State has not licensed any railway undertaking. Therefore, such Member States should be exempted from those obligations. (49) Processing of personal data should be carried out in accordance with Union law on the protection of personal data, in particular with Regulation (EU) 2016/679 of the European Parliament and of the Council (7). (50) Member States should lay down penalties applicable to infringements of this Regulation and ensure that these penalties are applied. The penalties, which might include the payment of compensation to the person in question, should be effective, proportionate and dissuasive. (51) Since the objectives of this Regulation, namely the development of the Union\u2019s railways and the strengthening of rail passengers\u2019 rights, cannot be sufficiently achieved by the Member States, and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (52) In order to ensure a high level of passenger protection, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annex I in respect of the CIV Uniform Rules and to adjust the minimum amount of the advance payment in the event of death of a passenger in view of changes in the EU-wide Harmonised Index of Consumer Prices. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (8). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (53) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (9). (54) This Regulation respects fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union, in particular Articles 21, 26, 38 and 47 concerning, respectively, the prohibition of any form of discrimination, the integration of persons with disabilities, the ensuring of a high level of consumer protection, and the right to an effective remedy and to a fair trial. The Member States\u2019 courts must apply this Regulation in a manner consistent with these rights and principles, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and objectives In order to provide for effective protection of passengers and encourage rail travel, this Regulation establishes rules applicable to rail transport as regards the following: (a) non-discrimination between passengers with regard to transport conditions and the provision of tickets; (b) the liability of railway undertakings and their insurance obligations for passengers and their luggage; (c) passengers\u2019 rights in the event of an accident arising from the use of railway services and resulting in death, personal injury or loss of, or damage to, their luggage; (d) passengers\u2019 rights in the event of disruption, such as cancellation or delay, including their right to compensation; (e) minimum and accurate information, including on the issuing of tickets, to be provided in an accessible format and in a timely manner to passengers; (f) non-discrimination against, and assistance for, persons with disabilities and persons with reduced mobility; (g) the definition and monitoring of service quality standards and the management of risks to the personal security of passengers; (h) the handling of complaints; (i) general rules on enforcement. Article 2 Scope 1. This Regulation shall apply to international and domestic rail journeys and services throughout the Union provided by one or more railway undertakings licensed in accordance with Directive 2012/34/EU of the European Parliament and of the Council (10). 2. Member States may exempt from the application of this Regulation services which are operated strictly for historical or touristic use. That exemption does not apply in relation to Articles 13 and 14. 3. Exemptions granted in accordance with Article 2(4) and (6) of Regulation (EC) No 1371/2007 before 6 June 2021 shall remain valid until the date that those exemptions expire. Exemptions granted in accordance with Article 2(5) of Regulation (EC) No 1371/2007 before 6 June 2021 shall remain valid until 7 June 2023. 4. Before the expiry of an exemption to the domestic rail passenger services granted pursuant to Article 2(4) of Regulation (EC) No 1371/2007, Member States may exempt such domestic rail passenger services from the application of Articles 15, 17 and 19, points (a) and (b) of Article 20(2) and Article 30(2) of this Regulation for an additional period of no more than five years. 5. Until 7 June 2030 Member States may provide that Article 10 shall not apply where it is not technically feasible for an infrastructure manager to distribute real-time data within the meaning of Article 10(1) to any railway undertaking, ticket vendor, tour operator or station manager. At least every two years, the Member States shall reassess the extent to which it is technically feasible to distribute such data. 6. Subject to paragraph 8, Member States may exempt the following services from the application of this Regulation: (a) urban, suburban and regional rail passenger services; (b) international rail passenger services of which a significant part, including at least one scheduled station stop, is operated outside the Union. 7. Member States shall inform the Commission of exemptions granted pursuant to paragraphs 2, 4, 5 and 6 and shall present the reasons for those exemptions. 8. Exemptions granted in accordance with point (a) of paragraph 6 shall not apply in relation to Articles 5, 11, 13, 14, 21, 22, 27 and 28. Where those exemptions concern regional rail passenger services, they shall also not apply in relation to Articles 6 and 12, Article 18(3) and Chapter V. Notwithstanding the second subparagraph of this paragraph, exemptions concerning regional rail passenger services to the application of Articles 12(1) and 18(3) may apply until 7 June 2028. Article 3 Definitions For the purposes of this Regulation the following definitions apply: (1) \u2018railway undertaking\u2019 means a railway undertaking as defined in point (1) of Article 3 of Directive 2012/34/EU; (2) \u2018infrastructure manager\u2019 means an infrastructure manager as defined in point (2) of Article 3 of Directive 2012/34/EU; (3) \u2018station manager\u2019 means an organisational entity in a Member State, which has been made responsible for the management of one or more railway stations and which may be the infrastructure manager; (4) \u2018tour operator\u2019 means an organiser or retailer as defined in points (8) and (9) respectively of Article 3 of Directive (EU) 2015/2302 of the European Parliament and of the Council (11) other than a railway undertaking; (5) \u2018ticket vendor\u2019 means any retailer of rail transport services selling tickets, including through-tickets, on the basis of a contract or other arrangement between the retailer and one or more railway undertakings; (6) \u2018transport contract\u2019 means a contract of rail carriage for reward or free of charge between a railway undertaking and a passenger for the provision of one or more transport services; (7) \u2018ticket\u2019 means valid evidence, regardless of its form, of the conclusion of a transport contract; (8) \u2018reservation\u2019 means an authorisation, on paper or in electronic form, giving entitlement to transportation subject to previously confirmed personalised transport arrangements; (9) \u2018through-ticket\u2019 means a through-ticket as defined in point (35) of Article 3 of Directive 2012/34/EU; (10) \u2018service\u2019 means a passenger rail transport service that operates between rail stations according to a timetable, including transport services offered for re-routing; (11) \u2018journey\u2019 means the carriage of a passenger between a station of departure and a station of arrival; (12) \u2018domestic rail passenger service\u2019 means a rail passenger service which does not cross a border of a Member State; (13) \u2018urban and suburban rail passenger service\u2019 means a rail passenger service within the meaning of point (6) of Article 3 of Directive 2012/34/EU; (14) \u2018regional rail passenger service\u2019 means a rail passenger service within the meaning of point (7) of Article 3 of Directive 2012/34/EU; (15) \u2018long-distance rail passenger service\u2019 means a rail passenger service which is not an urban, a suburban or a regional rail passenger service; (16) \u2018international rail passenger service\u2019 means a rail passenger service crossing at least one border of a Member State the principal purpose of which is to carry passengers between stations located in different Member States or in a Member State and a third country; (17) \u2018delay\u2019 means the time difference between the time the passenger was scheduled to arrive in accordance with the published timetable and the time of his or her actual or expected arrival at the station of final destination; (18) \u2018arrival\u2019 means the moment when the doors of the train are opened on the destination platform and disembarkation is allowed; (19) \u2018travel pass\u2019 or \u2018season ticket\u2019 means a ticket for an unlimited number of journeys which provides the authorised holder with rail travel on a particular route or network during a specified period; (20) \u2018missed connection\u2019 means a situation where a passenger misses one or more services in the course of a rail journey, sold in the form of a through-ticket, as a result of the delay or cancellation of one or more previous services, or of the departure of a service before the scheduled departure time; (21) \u2018person with disabilities\u2019 and \u2018person with reduced mobility\u2019 mean any person who has a permanent or temporary physical, mental, intellectual or sensory impairment which, in interaction with various barriers, may hinder his or her full and effective use of transport on an equal basis with other passengers or whose mobility when using transport is reduced due to age; (22) \u2018station\u2019 means a location on a railway where a rail passenger service can start, stop or end. CHAPTER II TRANSPORT CONTRACT, INFORMATION AND TICKETS Article 4 Transport contract Subject to the provisions of this Chapter, the conclusion and performance of a transport contract and the provision of information and tickets shall be governed by the provisions of Title II and Title III of Annex I. Article 5 Non-discriminatory contract conditions and tariffs Without prejudice to social tariffs, railway undertakings, ticket vendors or tour operators shall offer contract conditions and tariffs to the general public without direct or indirect discrimination on the basis of the passenger\u2019s nationality or of the place of establishment within the Union of the railway undertaking, ticket vendor or tour operator. The first paragraph of this Article also applies to railway undertakings and ticket vendors when accepting reservations from passengers in accordance with Article 11. Article 6 Bicycles 1. Subject to the limitations set out in paragraph 3, and where appropriate for a reasonable fee, passengers shall be entitled to take bicycles on board the train. On trains for which a reservation is required, it shall be possible to make a reservation for the carriage of a bicycle. Where a passenger has made a reservation for a bicycle and the carriage of that bicycle is refused without a duly justified reason, the passenger shall be entitled to re-routing or reimbursement in accordance with Article 18, compensation in accordance with Article 19 and assistance in accordance with Article 20(2). 2. Where designated places for bicycles are available on board the train, passengers shall stow their bicycles in such places. Where such places are not available, passengers shall keep their bicycles under supervision, and shall make all reasonable efforts to ensure that their bicycles cause no harm or damage to other passengers, mobility equipment, luggage or rail operations. 3. Railway undertakings may restrict the right of passengers to take bicycles on board the train for safety or operational reasons, in particular as a result of capacity limits applicable during peak hours, or where rolling stock does not permit it. Railway undertakings may also restrict the carriage of bicycles based on the weights and dimensions of the bicycles concerned. They shall publish their conditions for the transport of bicycles, including up-to-date information on the availability of capacity, by using the telematics applications referred to in Regulation (EU) No 454/2011 on their official websites. 4. When initiating procurement procedures for new rolling stock, or when performing a major upgrade of existing rolling stock resulting in the need for a new vehicle authorisation for placing on the market pursuant to Article 21(12) of Directive (EU) 2016/797 of the European Parliament and of the Council (12), railway undertakings shall ensure that train compositions, in which that rolling stock is used, are equipped with an adequate number of places for bicycles. This subparagraph shall not apply in relation to restaurant cars, sleeping cars or couchette cars. Railway undertakings shall determine an adequate number of places for bicycles taking into consideration the size of train composition, the type of service and the demand for transport of bicycles. The adequate number of places for bicycles shall be defined in plans referred to in paragraph 5. Where there are no such plans or the plans do not determine such a number, each train composition shall have at least four places for bicycles. Member States may set a number higher than four as the minimum adequate number for certain types of services, in which case that number shall apply instead of the number identified in accordance with the second subparagraph. 5. Railway undertakings may establish, and keep up-to-date, plans on how to increase and improve the transport of bicycles, and on other solutions encouraging combined use of railways and bicycles. The competent authorities, as defined in point (b) of Article 2 of Regulation (EC) No 1370/2007 of the European Parliament and of the Council (13), may establish such plans for services provided under public service contracts. Member States may require that such plans are established by those competent authorities or by railway undertakings operating on their territory. 6. The plans referred to in paragraph 5 shall be established following consultation of the public and relevant representative organisations. Those plans shall be published on the website of the railway undertaking or the competent authority, as appropriate. Article 7 Exclusion of waiver and stipulation of limits 1. Obligations towards passengers pursuant to this Regulation may not be limited or waived, notably by a derogation or restrictive clause in the transport contract. Any contractual conditions which purport directly or indirectly to waive, derogate from or restrict the rights resulting from this Regulation shall not be binding on the passenger. 2. Railway undertakings, tour operators or ticket vendors may offer contractual conditions which are more favourable for the passenger than the conditions laid down in this Regulation. Article 8 Obligation to provide information concerning discontinuation of services Railway undertakings or, where appropriate, competent authorities responsible for a public service railway contract shall make public by appropriate means, including in accessible formats in accordance with the provisions of Directive (EU) 2019/882 and Regulations (EU) No 454/2011 and (EU) No 1300/2014, and before their implementation, decisions to discontinue services either permanently or temporarily. Article 9 Travel information 1. Railway undertakings, tour operators and ticket vendors offering transport contracts on behalf of one or more railway undertakings shall provide the passenger, upon request, with at least the information set out in Annex II, Part I in relation to the journeys for which a transport contract is offered by the railway undertaking concerned. 2. Railway undertakings and, where possible, ticket vendors and tour operators shall provide the passenger during the journey with at least the information set out in Annex II, Part II. Where a station manager has such information, he or she shall also provide the information to the passenger. 3. The information referred to in paragraphs 1 and 2 shall be provided in the most appropriate format, where possible based on real-time travel information, including by using appropriate communication technologies. Particular attention shall be paid to ensuring that this information is accessible in accordance with the provisions of Directive (EU) 2019/882 and Regulations (EU) No 454/2011 and (EU) No 1300/2014. Article 10 Access to traffic and travel information 1. Infrastructure managers shall distribute real-time data relating to the arrival and the departure of trains to railway undertakings, ticket vendors, tour operators and station managers. 2. Railway undertakings shall provide other railway undertakings, ticket vendors and tour operators that sell their services with access to minimum travel information set out in Annex II, Parts I and II, and to the operations on reservation systems referred to in Annex II, Part III. 3. Information shall be distributed and access shall be granted in a non-discriminatory manner and without undue delay. A one-off request shall be sufficient to have continuous access to information. The infrastructure manager and the railway undertaking obliged to make available information in accordance with paragraphs 1 and 2 may request the conclusion of a contract or other arrangement on whose basis information is distributed or access is granted. The terms and conditions of any contract or arrangement for the use of the information shall not unnecessarily restrict possibilities for its reuse or be used to restrict competition. Railway undertakings may require from other railway undertakings, tour operators and ticket vendors a fair, reasonable and proportionate financial compensation for the costs incurred in providing the access, and infrastructure managers may require compensation in accordance with the applicable rules. 4. Information shall be distributed and access shall be provided by appropriate technical means, such as application programming interfaces. 5. To the extent that the information covered by paragraphs 1 or 2 is provided in accordance with other Union legal acts, in particular Commission Delegated Regulation (EU) 2017/1926 (14), the corresponding obligations under this Article shall be deemed to have been complied with. Article 11 Availability of tickets and reservations 1. Railway undertakings, ticket vendors and tour operators shall offer tickets and, where available, through-tickets and reservations. 2. Without prejudice to paragraphs 3 and 4, railway undertakings shall sell, either directly or through ticket vendors or tour operators, tickets to passengers via at least one of the following means of sale: (a) ticket offices, other points of sale or ticketing machines; (b) telephone, the internet or any other widely available information technology; (c) on board trains. The competent authorities, as defined in point (b) of Article 2 of Regulation (EC) No 1370/2007, may require railway undertakings to offer tickets for services provided under public service contracts via more than one means of sale. 3. Where there is no ticket office or ticketing machine in the station of departure, passengers shall be informed at the station of: (a) the possibility of purchasing tickets via telephone or the Internet or on board the train, and of the procedure for such purchase; (b) the nearest railway station or place at which ticket offices or ticketing machines are available. 4. Where there is no ticket office or no accessible ticketing machine in the station of departure and no other accessible means to purchase a ticket in advance, persons with disabilities shall be permitted to buy tickets on board the train at no extra cost. Railway undertakings may limit or deny this right on justifiable grounds related to security or compulsory train reservation. Where there is no staff on board the train, the railway undertaking shall advise the persons with disabilities whether to and inform them on how to purchase the ticket. Member States may allow railway undertakings to require that persons with disabilities are recognised as such in accordance with the relevant national law and practices of the country of their residence. Member States may extend the right referred to in the first subparagraph to all passengers. Where Member States apply this option, they shall inform the Commission accordingly. The European Union Agency for Railways shall publish the information on its website relating to the implementation of Regulations (EU) No 454/2011 and (EU) No 1300/2014. Article 12 Through-tickets 1. Where long-distance or regional rail passenger services are operated by a sole railway undertaking, that undertaking shall offer a through-ticket for those services. For other rail passenger services, railway undertakings shall make all reasonable efforts to offer through-tickets and shall cooperate to that end among themselves. For the purpose of the first subparagraph the term \u2018sole railway undertaking\u2019 shall also include all railway undertakings which are either wholly owned by the same owner or which are wholly-owned subsidiary undertakings of one of the railway undertakings involved. 2. For journeys including one or more connections, the passenger shall be informed prior to purchasing a ticket or tickets whether that ticket or those tickets constitute a through-ticket. 3. For journeys including one or more connections, a ticket or tickets, purchased in a single commercial transaction from a railway undertaking, shall constitute a through-ticket and the railway undertaking shall be liable in accordance with Articles 18, 19 and 20 if the passenger misses one or more connections. 4. Where a ticket or tickets are purchased in a single commercial transaction and the ticket vendor or tour operator has combined the tickets on its own initiative, the ticket vendor or tour operator that sold the ticket or tickets shall be liable to reimburse the total amount paid for that transaction for the ticket or tickets and, moreover, to pay compensation equivalent to 75 % of that amount in the event that the passenger misses one or more connections. The right to reimbursement or to compensation referred to in the first subparagraph is without prejudice to applicable national law granting passengers further compensation for damage. 5. The liabilities set out in paragraphs 3 and 4 shall not apply if it is mentioned on the tickets, or on another document or electronically in such a manner that allows the passenger to reproduce the information for future reference, that the tickets represent separate transport contracts, and the passenger was informed of this prior to the purchase. 6. The burden of proof that the passenger was provided with the information referred to in this Article shall lie with the railway undertaking, tour operator or ticket vendor that sold the ticket or tickets. 7. The ticket vendors or the tour operators shall be responsible for handling requests and possible complaints of the passenger under paragraph 4. The reimbursement and the compensation referred to in paragraph 4 shall be paid within 30 days after the receipt of the request. CHAPTER III LIABILITY OF RAILWAY UNDERTAKINGS FOR PASSENGERS AND THEIR LUGGAGE Article 13 Liability for passengers and luggage Subject to the provisions of this Chapter, and without prejudice to applicable national law granting passengers further compensation for damages, the liability of railway undertakings in respect of passengers and their luggage shall be governed by Chapters I, III and IV of Title IV, Title VI and Title VII of Annex I. Article 14 Insurance and coverage of liability A railway undertaking shall be adequately insured or have adequate guarantees under market conditions to cover its liabilities, in accordance with Article 22 of Directive 2012/34/EU. Article 15 Advance payments 1. If a passenger is killed or injured, the railway undertaking as referred to in Article 26(5) of Annex I shall without delay, and in any event not later than 15 days after the establishment of the identity of the natural person entitled to compensation, make such advance payments as may be required to meet immediate economic needs on a basis proportional to the damage suffered. 2. Without prejudice to paragraph 1, an advance payment shall not be less than EUR 21 000 per passenger in the event of death. 3. An advance payment shall not constitute recognition of liability and may be offset against any subsequent sums paid on the basis of this Regulation but is not returnable, except where damage was caused by the negligence or fault of the passenger or where the person who received the advance payment was not the person entitled to compensation. Article 16 Contestation of liability Even if the railway undertaking contests its responsibility for physical injury to a passenger whom it conveys, it shall make every reasonable effort to assist the passenger with his or her claim for compensation for damage from third parties. CHAPTER IV DELAYS, MISSED CONNECTIONS AND CANCELLATIONS Article 17 Liability for delays, missed connections and cancellations Subject to the provisions of this Chapter, the liability of railway undertakings in respect of delays, missed connections and cancellations shall be governed by Chapter II of Title IV of Annex I. Article 18 Reimbursement and re-routing 1. Where it is reasonably to be expected, either at departure or in the event of a missed connection or a cancellation, that arrival at the final destination under the transport contract will be subject to a delay of 60 minutes or more, the railway undertaking operating the delayed or cancelled service shall immediately offer the passenger the choice between one of the following options, and shall make the necessary arrangements: (a) reimbursement of the full cost of the ticket, under the conditions by which it was paid, for the part or parts of his or her journey not made and for the part or parts already made if the journey is no longer serving any purpose in relation to the passenger\u2019s original travel plan, together with, when relevant, a return service to the first point of departure at the earliest opportunity; (b) continuation or re-routing, under comparable transport conditions, to the final destination at the earliest opportunity; (c) continuation or re-routing, under comparable transport conditions, to the final destination at a later date at the passenger\u2019s convenience. 2. Where, for the purposes of points (b) and (c) of paragraph 1, comparable re-routing is operated by the same railway undertaking or another undertaking is commissioned to perform the re-routing, this shall not generate additional costs to the passenger. This requirement also applies where the re-routing involves the use of transport of a higher service class and alternative modes of transport. Railway undertakings shall make reasonable efforts to avoid additional connections and to ensure that delay in the total travel time is as short as possible. Passengers shall not be downgraded to transport facilities of a lower class unless such facilities are the only re-routing means available. 3. Without prejudice to paragraph 2, the railway undertaking may allow the passenger, at his or her request, to conclude contracts with other providers of transport services which enable the passenger to reach the final destination under comparable conditions, in which case the railway undertaking shall reimburse the passenger for the costs that he or she incurs. Where the available re-routing options are not communicated to the passenger within 100 minutes from the scheduled departure time of the delayed or cancelled service or the missed connection, the passenger shall be entitled to conclude such a contract with other providers of public transport services by rail, coach or bus. The railway undertaking shall reimburse the passenger for the necessary, appropriate and reasonable costs that he or she incurs. This paragraph shall not affect national laws, regulations or administrative provisions which grant more favourable re-routing conditions to passengers. 4. Re-routing transport service providers shall provide persons with disabilities and persons with reduced mobility with a comparable level of assistance and accessibility when offering an alternative service. Re-routing transport service providers may provide persons with disabilities and persons with reduced mobility with alternative services which are appropriate to their needs and which differ from those offered to other passengers. 5. The reimbursements referred to in point (a) of paragraph 1 and in paragraph 3 shall be paid within 30 days after the receipt of the request. Member States may require railway undertakings to accept such requests by particular means of communication, provided that the request does not create discriminatory effects. The reimbursement may take the form of vouchers and/or the provision of other services provided that the terms of those vouchers and/or services are sufficiently flexible, in particular regarding the validity period and destination, and that the passenger agrees to accept those vouchers and/or services. The reimbursement of the ticket price shall not be reduced by financial transaction costs such as fees, telephone costs or stamps. 6. The Commission shall adopt an implementing act establishing a common form for reimbursement requests under this Regulation by 7 June 2023. That common form shall be established in a format which is accessible to persons with disabilities and persons with reduced mobility. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 38(2). 7. Passengers shall have the right to submit their requests using the common form referred to in paragraph 6. Railway undertakings shall not reject a request for reimbursement solely on the grounds that the passenger has not used that form. If a request is not sufficiently precise, the railway undertaking shall ask the passenger to clarify the request and shall assist the passenger to do so. Article 19 Compensation 1. Without losing the right of transport, a passenger is entitled to compensation for delays from the railway undertaking if he or she is facing a delay between the places of departure and final destination stated in the ticket or through-ticket for which the cost has not been reimbursed in accordance with Article 18. The minimum compensation for delays shall be as follows: (a) 25 % of the ticket price for a delay of 60 to 119 minutes; (b) 50 % of the ticket price for a delay of 120 minutes or more. 2. Paragraph 1 shall also apply to passengers who hold a travel pass or season ticket. If those passengers encounter recurrent delays or cancellations during the period of validity of the travel pass or season ticket, they shall be entitled to adequate compensation in accordance with the railway undertaking\u2019s compensation arrangements. These arrangements shall state the criteria for determining delay and for the calculation of the compensation. Where delays of less than 60 minutes occur repeatedly during the period of validity of the travel pass or season ticket, the delays may be counted cumulatively and passengers may be compensated in accordance with the railway undertaking\u2019s compensation arrangements. 3. Without prejudice to paragraph 2, compensation for delay shall be calculated in relation to the full price which the passenger actually paid for the delayed service. Where the transport contract is for a return journey, compensation for delay on either the outward or the return leg shall be calculated in relation to the price indicated for that leg of the journey on the ticket. Where there is no such indication of the price of the individual legs of the journey, the compensation shall be calculated in relation to half of the price paid for the ticket. In the same way, the price for a delayed service provided under any other form of transport contract entitling the passenger to travel for two or more subsequent legs shall be calculated in proportion to the full price. 4. The calculation of the period of delay shall not take into account any delay that the railway undertaking can demonstrate as having occurred outside the Union. 5. The Commission shall adopt an implementing act establishing a common form for compensation requests under this Regulation by 7 June 2023. That common form shall be established in a format which is accessible to persons with disabilities and persons with reduced mobility. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 38(2). 6. Member States may require railway undertakings to accept requests for compensation by particular means of communication, provided that the request does not create discriminatory effects. Passengers shall have the right to submit their requests using the common form referred to in paragraph 5. Railway undertakings shall not reject a request for compensation solely on the grounds that the passenger has not used that form. If a request is not sufficiently precise, the railway undertaking shall ask the passenger to clarify the request and shall assist the passenger to do so. 7. The compensation of the ticket price shall be paid within one month after the submission of the request for compensation. The compensation may be paid in vouchers and/or other services if the terms are flexible, in particular regarding the validity period and destination. The compensation shall be paid in money at the request of the passenger. 8. The compensation of the ticket price shall not be reduced by financial transaction costs such as fees, telephone costs or stamps. Railway undertakings may introduce a minimum threshold under which payments for compensation will not be paid. This threshold shall not exceed EUR 4 per ticket. 9. Passengers shall not have any right to compensation if they are informed of a delay before buying a ticket, or if a delay due to continuation on a different service or re-routing remains below 60 minutes. 10. A railway undertaking shall not be obliged to pay compensation if it can prove that the delay, missed connection or cancellation was caused directly by, or was inherently linked with: (a) extraordinary circumstances not connected with the operation of the railway, such as extreme weather conditions, major natural disasters or major public health crises, which the railway undertaking, in spite of having taken the care required in the particular circumstances of the case, was unable to avoid and the consequences of which it was unable to prevent; (b) fault on the part of the passenger; or (c) the behaviour of a third party which the railway undertaking, in spite of having taken the care required in the particular circumstances of the case, was unable to avoid and the consequences of which it was unable to prevent, such as persons on the track, cable theft, on-board emergencies, law enforcement activities, sabotage or terrorism. Strikes by the personnel of the railway undertaking, acts or omissions by another undertaking using the same railway infrastructure and acts or omissions of the infrastructure and station managers are not covered by the exemption referred to in point (c) of the first subparagraph. Article 20 Assistance 1. In the case of a delay in arrival or departure, or cancellation of a service, passengers shall be kept informed of the situation and of the estimated departure time and estimated arrival time of the service or the replacement service by the railway undertaking or by the station manager as soon as such information is available. Where ticket vendors and tour operators have such information, they shall also provide it to the passenger. 2. Where the delay referred to in paragraph 1 amounts to 60 minutes or more, or the service is cancelled, the railway undertaking operating the delayed or cancelled service shall offer the passengers the following, free of charge: (a) meals and refreshments in reasonable relation to the waiting time, if they are available on the train or in the station, or can reasonably be supplied, taking into account criteria such as the distance from the supplier, the time required for delivery and the cost; (b) hotel or other accommodation, and transport between the railway station and place of accommodation, in cases where a stay of one or more nights becomes necessary or an additional stay becomes necessary, where and when physically possible. In cases where such a stay becomes necessary due to the circumstances referred to in Article 19(10), the railway undertaking may limit the duration of accommodation to a maximum of three nights. The access requirements of persons with disabilities and persons with reduced mobility and the needs of assistance dogs shall be taken into account, whenever possible; (c) if the train is blocked on the track, transport from the train to the railway station, to the alternative departure point or to the final destination of the service, where and when physically possible. 3. If the railway service is interrupted and cannot be continued anymore or cannot be continued within a reasonable period, railway undertakings shall provide passengers as soon as possible with alternative transport services and make the necessary arrangements. 4. Railway undertakings shall inform affected passengers how to request certification that the rail service has suffered a delay, led to a missed connection or that it has been cancelled. This certification shall also apply in connection with the provisions laid down in Article 19. 5. In applying paragraphs 1 to 4, the operating railway undertaking shall pay particular attention to the needs of persons with disabilities and persons with reduced mobility, as well as to those of any accompanying persons and assistance dogs. 6. Where contingency plans are established pursuant to Article 13a(3) of Directive 2012/34/EU, the railway undertakings shall coordinate with the station manager and infrastructure manager in order to prepare them for the possibility of major disruption and long delays leading to a considerable number of passengers being stranded in the station. Such contingency plans shall include requirements for the accessibility of alert and information systems. CHAPTER V PERSONS WITH DISABILITIES AND PERSONS WITH REDUCED MOBILITY Article 21 Right to transport 1. Railway undertakings and station managers shall, with the active involvement of representative organisations and, where relevant, representatives of persons with disabilities and persons with reduced mobility, establish or have in place non-discriminatory access rules for the transport of persons with disabilities, including their personal assistants recognised as such in accordance with national practices, and persons with reduced mobility. Those rules shall take into account the agreements referred to in point 4.4.3 of the Annex to Regulation (EU) No 1300/2014, in particular with regard to the entity responsible for providing assistance to persons with disabilities and persons with reduced mobility. 2. Reservations and tickets shall be offered to persons with disabilities and persons with reduced mobility at no additional cost. A railway undertaking, ticket vendor or tour operator may not refuse to accept a reservation from, or to issue a ticket to, a person with disabilities or a person with reduced mobility, or require that such person be accompanied by another person, unless this is strictly necessary in order to comply with the access rules referred to in paragraph 1. Article 22 Information to persons with disabilities and persons with reduced mobility 1. Upon request, a station manager, a railway undertaking, a ticket vendor or a tour operator shall provide persons with disabilities and persons with reduced mobility with information, including in accessible formats in accordance with the provisions of Regulations (EU) No 454/2011 and (EU) No 1300/2014 and Directive (EU) 2019/882, on the accessibility of the station and associated facilities, and of rail services and on the access conditions of rolling stock in accordance with the access rules referred to in Article 21(1) and shall inform persons with disabilities and persons with reduced mobility about facilities on board. 2. When a railway undertaking, ticket vendor or tour operator makes use of the derogation provided for in Article 21(2), it shall upon request inform in writing the person with disabilities or person with reduced mobility concerned of its reasons for doing so within five working days of the refusal to accept the reservation or to issue the ticket or of the imposition of the condition of being accompanied. The railway undertaking, ticket vendor or tour operator shall make reasonable efforts to propose acceptable alternative transport to the person in question taking into account his or her accessibility needs. 3. In unstaffed stations, railway undertakings and station managers shall ensure that easily available information, including in accessible formats in accordance with the provisions of Regulations (EU) No 454/2011 and (EU) No 1300/2014 and Directive (EU) 2019/882, is displayed in accordance with the access rules referred to in Article 21(1) regarding the nearest staffed stations and regarding directly available assistance for persons with disabilities and persons with reduced mobility. Article 23 Assistance at railway stations and on board 1. Persons with disabilities or persons with reduced mobility shall be assisted as follows: (a) the personal assistant, recognised as such in accordance with national practices, may travel with a special tariff and, if applicable, free of charge and be seated, where practicable, next to the person with disabilities; (b) where a railway undertaking requires that a passenger needs to be accompanied on board the train in accordance with Article 21(2), the accompanying person shall be entitled to travel free of charge and to be seated, where practicable, next to the person with disabilities or to the person with reduced mobility; (c) an assistance dog shall be permitted to accompany them in accordance with any relevant national law; (d) for unstaffed trains, station managers or railway undertakings shall provide assistance free of charge, in conformity with the access rules referred to in Article 21(1), during boarding and alighting from a train when there is trained staff on duty at the station; (e) on departure from, transit through or arrival at a staffed railway station, the station manager or the railway undertaking shall provide assistance free of charge in such a way that that person is able to board the train, to transfer to a connecting rail service for which he or she has a ticket, or to alight from the train, provided there is trained staff on duty. Where the need for assistance has been notified in advance in accordance with point (a) of Article 24, the station manager or the railway undertaking shall ensure that assistance is provided as requested; (f) at unstaffed stations, railway undertakings shall provide assistance free of charge on board a train and during boarding and alighting from a train if the train is accompanied by trained staff; (g) in the absence of trained accompanying staff on board a train and at a station, station managers or railway undertakings shall make all reasonable efforts to enable persons with disabilities or persons with reduced mobility to have access to travel by rail; (h) railway undertakings shall make all reasonable efforts to provide persons with disabilities or persons with reduced mobility with access to the same on-board services as other passengers, where these persons cannot have access to those services independently and safely. 2. The rules referred to in Article 21(1) shall establish the arrangements for the exercise of the rights referred to in paragraph 1 of this Article. Article 24 Conditions under which assistance is provided Railway undertakings, station managers, ticket vendors and tour operators shall cooperate in order to provide assistance free of charge to persons with disabilities and persons with reduced mobility, as specified in Articles 21 and 23, offering a single notification mechanism, in accordance with the following points: (a) assistance shall be provided on condition that the railway undertaking, the station manager, the ticket vendor or the tour operator with which the ticket was purchased, or the Single Point of Contact referred to in point (f), where applicable, is notified of the passenger\u2019s need for such assistance at least 24 hours before the assistance is needed. A single notification per journey shall be sufficient. Such notifications shall be forwarded to all railway undertakings and station managers involved in the journey. Such notifications shall be accepted without additional costs, irrespective of the means of communication being used. Where a ticket or season ticket permits multiple journeys, one notification shall be sufficient provided that adequate information on the timing of subsequent journeys is provided, and in any case at least 24 hours before the first time the assistance is needed. The passenger or his/her representative shall make all reasonable efforts to inform of any annulation of such subsequent journeys at least 12 hours in advance. Member States may allow the 24-hour period for notifications referred to in the first, second and third subparagraphs to be extended up to 36 hours, but not beyond 30 June 2026. In such cases, Member States shall notify the Commission of that permission and provide information on the measures taken or envisaged to reduce the period; (b) railway undertakings, station managers, ticket vendors and tour operators shall take all measures necessary for the reception of notifications. Where ticket vendors are unable to process such notifications, they shall indicate alternative points of purchase or alternative means to make the notification; (c) if no notification is made in accordance with point (a), the railway undertaking and the station manager shall make all reasonable efforts to provide assistance in such a way that the person with disabilities or person with reduced mobility may travel; (d) without prejudice to point (f) of this Article, the station manager or any other authorised person shall designate points at which persons with disabilities and persons with reduced mobility can make their arrival at the railway station known and request assistance. The responsibilities regarding the designation of such points and the provision of information about them shall be established in the access rules referred to in Article 21(1); (e) assistance shall be provided on condition that the person with disabilities or person with reduced mobility presents him or herself at the designated point at a time stipulated by the railway undertaking or station manager providing such assistance. Any time stipulated shall not be more than 60 minutes before the published departure time or the time at which all passengers are asked to check in. If no time is stipulated by which the person with disabilities or person with reduced mobility is required to present him or herself, the person shall present him or herself at the designated point at least 30 minutes before the published departure time or before the time at which all passengers are asked to check in; (f) Member States may require that station managers and railway undertakings on their territory cooperate to establish and to operate Single Points of Contact for persons with disabilities and persons with reduced mobility. The terms for the operation of the Single Points of Contact shall be established in the access rules referred to in Article 21(1). Those Single Points of Contact have the responsibility to: (i) accept requests for assistance at stations; (ii) communicate individual requests for assistance to station managers and railway undertakings; and (iii) provide information on accessibility. Article 25 Compensation in respect of mobility equipment, assistive devices and assistance dogs 1. Where railway undertakings and station managers cause the loss of, or damage to, mobility equipment, including wheelchairs, and assistive devices, or the loss of, or injury to, assistance dogs used by persons with disabilities and persons with reduced mobility, they shall be liable for that loss, damage or injury, and provide compensation without undue delay. That compensation shall comprise: (a) the cost of replacement or repair of the mobility equipment or assistive devices lost or damaged; (b) the cost of replacement or the treatment of the injury of an assistance dog that was lost or injured; and (c) reasonable costs of temporary replacement for mobility equipment, assistive devices or assistance dogs where such replacement is not provided by the railway undertaking or the station manager in accordance with paragraph 2. 2. Where paragraph 1 applies, railway undertakings and station managers shall rapidly make all reasonable efforts to provide immediately needed temporary replacements for mobility equipment or assistive devices. The person with disabilities or the person with reduced mobility shall be permitted to keep that temporary replacement equipment or device until the compensation referred to in paragraph 1 has been paid. Article 26 Staff training 1. Railway undertakings and station managers shall ensure that all staff, including those newly recruited, providing, in their regular duties, direct assistance to persons with disabilities and persons with reduced mobility, receive disability-related training in order to know how to meet the needs of persons with disabilities and of persons with reduced mobility. They shall also provide all staff, working at the station or on board trains, who deal directly with the travelling public with training and regular refresher training courses to raise awareness of the needs of persons with disabilities and persons with reduced mobility. 2. Railway undertakings and station managers may accept the participation, in the training referred to in paragraph 1, of employees with disabilities, and may consider the participation of passengers with disabilities and passengers with reduced mobility, and/or organisations representing them. CHAPTER VI SECURITY, COMPLAINTS AND QUALITY OF SERVICE Article 27 Personal security of passengers In agreement with public authorities, railway undertakings, infrastructure managers and station managers shall take adequate measures in their respective fields of responsibility and adapt them to the level of security defined by the public authorities to ensure passengers\u2019 personal security in railway stations and on trains and to manage risks. They shall cooperate and exchange information on best practices concerning the prevention of acts which are likely to deteriorate the level of security. Article 28 Complaints 1. Each railway undertaking and station manager of a station handling on average more than 10 000 passengers per day over a year shall set up a complaint-handling mechanism for the rights and obligations covered by this Regulation in their respective fields of responsibility. They shall make their contact details and working language, or languages, widely known to passengers. This mechanism shall not apply for the purposes of Chapter III. 2. Passengers may submit a complaint to any railway undertaking or station manager regarding their respective fields of responsibility via the mechanisms referred to in paragraph 1. Such a complaint shall be submitted within three months of the incident that it concerns. Within one month of receiving the complaint, the addressee shall either give a reasoned reply or, in justified cases, inform the passenger that he or she will receive a reply within a period of less than three months from the date of receipt of the complaint. Railway undertakings and station managers shall keep the data necessary to assess the complaint for the duration of the entire complaint-handling procedure, including the complaint-handling procedures referred to in Articles 33 and 34, and shall make that data available to national enforcement bodies upon request. 3. Details of the complaint-handling procedure shall be accessible to the public, including to persons with disabilities and to persons with reduced mobility. This information shall be available upon request at least in the official language or languages of the Member State in which the railway undertaking is operating. 4. The railway undertaking shall publish in the report referred to in Article 29(2) the number and categories of received complaints and of processed complaints, the response time and the possible improvement actions undertaken. Article 29 Service quality standards 1. Railway undertakings shall establish service quality standards and implement a quality management system to maintain service quality. The service quality standards shall at least cover the items listed in Annex III. 2. Railway undertakings shall monitor their own performance as reflected in the service quality standards. By 30 June 2023, and every two years thereafter, they shall publish a report on their service quality performance on their website. Such reports shall also be made available on the website of the European Union Agency for Railways. 3. Station managers shall establish service quality standards based on the relevant items listed in Annex III. They shall monitor their performance pursuant to those standards and provide access to the information on their performance to the national public authorities on request. CHAPTER VII INFORMATION AND ENFORCEMENT Article 30 Information to passengers about their rights 1. When selling tickets for journeys by rail, railway undertakings, station managers, ticket vendors and tour operators shall inform passengers of their rights and obligations under this Regulation. In order to comply with this information requirement, they may use a summary of the provisions of this Regulation prepared by the Commission in all official languages of the Union and made available to them. They shall provide that information, in either paper or electronic format, or by any other means, including in accessible formats in accordance with the provisions of Directive (EU) 2019/882 and Regulation (EU) No 1300/2014. They shall specify where, in the event of cancellation, missed connection or long delay, such information can be obtained. 2. Railway undertakings and station managers shall inform passengers in an appropriate manner, including in accessible formats in accordance with the provisions of Directive (EU) 2019/882 and Regulation (EU) No 1300/2014, at the station, on the train and on their website, of their rights and obligations under this Regulation, and of the contact details of the body or bodies designated by Member States pursuant to Article 31. Article 31 Designation of national enforcement bodies 1. Each Member State shall designate a body or bodies responsible for the enforcement of this Regulation. Each body shall take the measures necessary to ensure that the rights of passengers are respected. 2. Each body shall be independent in its organisation, funding decisions, legal structure and decision-making of any infrastructure manager, charging body, allocation body or railway undertaking. 3. Member States shall inform the Commission of the body or bodies designated in accordance with this Article and of its or their respective responsibilities. The Commission and the bodies designated shall publish that information on their websites. 4. The enforcement obligations as regards station managers and infrastructure managers provided for in this Chapter shall not apply to Cyprus or Malta for as long as no railway system is established within their respective territories and as regards railway undertakings for as long as no railway undertaking has been licensed by a licensing authority designated by Cyprus or Malta in accordance with Article 2(1). Article 32 Enforcement tasks 1. The national enforcement bodies shall closely monitor compliance with this Regulation, including with Regulations (EU) No 454/2011 and (EU) No 1300/2014 as far as those Regulations are referred to in this Regulation, and shall take the measures necessary to ensure that the rights of passengers are upheld. 2. For the purpose of paragraph 1, railway undertakings, station managers, infrastructure managers, ticket vendors and tour operators shall provide the national enforcement bodies with relevant documents and information at their request without undue delay and, in any event, within one month from the receipt of the request. In complex cases, the national enforcement body may extend this period to a maximum of three months from the receipt of the request. In carrying out their functions, the national enforcement bodies shall take account of the information submitted to them by the body designated under Article 33 to handle complaints, if this is a different body. They may also decide on enforcement actions based on individual complaints transmitted by such a body. 3. Every two years, the national enforcement bodies shall publish reports with statistics on their activity, including on penalties applied by 30 June of the following calendar year. Those reports shall be made available on the website of the European Union Agency for Railways. 4. Railway undertakings shall give their contact details to the national enforcement body or bodies of the Member States in which they operate. Article 33 Complaint handling by national enforcement bodies and other bodies 1. Without prejudice to the rights of consumers to seek alternative redress pursuant to Directive 2013/11/EU of the European Parliament and of the Council (15), after having complained unsuccessfully to the railway undertaking or station manager pursuant to Article 28 the passenger may complain to the national enforcement body or any other body designated under paragraph 2 of this Article within three months from receiving information on the rejection of the original complaint. Where no reply is received within three months from making the original complaint, the passenger shall have the right to complain to the national enforcement body or any other body designated under paragraph 2. Where necessary, that body shall inform the complainant about his or her right to complain to alternative dispute resolution bodies to seek individual redress. 2. Any passenger may complain about an alleged infringement of this Regulation either to the national enforcement body, or to any other body designated by a Member State for that purpose. 3. The national enforcement body or any other body designated under paragraph 2 shall acknowledge receipt of the complaint within two weeks of receiving it. The complaint-handling procedure shall take a maximum of three months from the date of the establishment of the complaint file. For complex cases, that body may extend that period to six months. In such a case, it shall inform the passenger of the reasons for the extension and of the expected time needed to conclude the procedure. Only those cases that involve legal proceedings may take longer than six months. Where that body is also an alternative dispute resolution body within the meaning of Directive 2013/11/EU, the time limits laid down in that Directive shall prevail. The complaint-handling procedure shall be made accessible to persons with disabilities and to persons with reduced mobility. 4. Passenger complaints about an incident involving a railway undertaking shall be handled by the national enforcement body or any other body designated under paragraph 2 of the Member State that granted that undertaking\u2019s licence. 5. Where a complaint relates to alleged infringements by station or infrastructure managers, the complaint shall be handled by the national enforcement body or any other body designated under paragraph 2 of the Member State on whose territory the incident occurred. 6. In the framework of cooperation pursuant to Article 34, the national enforcement bodies may derogate from paragraphs 4 or 5 of this Article, or both of them, where for justified reasons, in particular those related to language or place of residence, this is in the passenger\u2019s interest. Article 34 Exchange of information and cross-border cooperation between national enforcement bodies 1. Where different bodies are designated under Articles 31 and 33, reporting mechanisms shall be set up to ensure the exchange of information between them, in accordance with Regulation (EU) 2016/679, in order to help the national enforcement body to carry out its tasks of supervision and enforcement, and so that the complaint-handling body designated under Article 33 can collect the information necessary to examine individual complaints. 2. National enforcement bodies shall exchange information on their work and decision-making principles and practices for the purpose of coordination. The Commission shall support them in that task. 3. In complex cases such as those involving multiple complaints or a number of operators, cross-border travel or accidents on the territory of a Member State other than that which granted the undertaking\u2019s licence, and in particular where it is unclear which national enforcement body is competent, or where it would facilitate or accelerate the resolution of the complaint, national enforcement bodies shall cooperate to identify a lead body, which shall serve as a single point of contact for passengers. All national enforcement bodies involved shall cooperate to facilitate the resolution of the complaint, including by sharing information, assisting with the translation of documents and providing information on the circumstances of incidents. Passengers shall be informed which body is acting as lead body. CHAPTER VIII FINAL PROVISIONS Article 35 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures and shall notify it without delay of any subsequent amendment affecting them. 2. In the framework of cooperation referred to in Article 34 the national enforcement body which is competent for the purposes of Article 33(4) or (5) shall, at the request of the national enforcement body handling the complaint, investigate the infringement of this Regulation identified by that body and, if necessary, impose penalties. Article 36 Delegated acts The Commission is empowered to adopt delegated acts in accordance with Article 37 amending this Regulation in order to: (a) adjust the financial amount stated in Article 15(2) to take account of changes in the EU-wide Harmonised Index of Consumer Prices excluding energy and unprocessed food, as published by the Commission (Eurostat); (b) modify Annex I in order to take account of amendments to the Uniform Rules concerning the Contract for International Carriage of Passengers and Luggage by Rail (CIV), as set out in Appendix A to the Convention concerning International Carriage by Rail (COTIF). Article 37 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 36 shall be conferred on the Commission for a period of five years from 6 June 2021. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 36 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following that of its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 36 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months from notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 38 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 39 Report By 7 June 2026, the Commission shall report to the European Parliament and the Council on the implementation and the results of this Regulation. The report shall be based on information to be provided pursuant to this Regulation. The report shall, where necessary, be accompanied by appropriate proposals. Article 40 Repeal Regulation (EC) No 1371/2007 is repealed with effect from 7 June 2023. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IV. Article 41 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 7 June 2023. However, Article 6(4) shall apply 7 June 2025. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 April 2021. For the European Parliament The President D.M. SASSOLI For the Council The President A.P. ZACARIAS (1) OJ C 197, 8.6.2018, p. 66. (2) Position of the European Parliament of 15 November 2018 (OJ C 363, 28.10.2020, p. 296) and position of the Council at first reading of 25 January 2021 (OJ C 68, 26.2.2021, p. 1). Position of the European Parliament of 29 April 2021 (not yet published in the Official Journal). (3) Regulation (EC) No 1371/2007 of the European Parliament and of the Council of 23 October 2007 on rail passengers\u2019 rights and obligations (OJ L 315, 3.12.2007, p. 14). (4) Commission Regulation (EU) No 454/2011 of 5 May 2011 on the technical specification for interoperability relating to the subsystem \u2018telematics applications for passenger services\u2019 of the trans-European rail system (OJ L 123, 12.5.2011, p. 11). (5) Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70). (6) Commission Regulation (EU) No 1300/2014 of 18 November 2014 on the technical specifications for interoperability relating to accessibility of the Union\u2019s rail system for persons with disabilities and persons with reduced mobility (OJ L 356, 12.12.2014, p. 110). (7) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (8) OJ L 123, 12.5.2016, p. 1. (9) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (10) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32). (11) Directive (EU) 2015/2302 of the European Parliament and of the Council of 25 November 2015 on package travel and linked travel arrangements, amending Regulation (EC) No 2006/2004 and Directive 2011/83/EU of the European Parliament and of the Council and repealing Council Directive 90/314/EEC (OJ L 326, 11.12.2015, p. 1). (12) Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44). (13) Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road and repealing Council Regulations (EEC) Nos 1191/69 and 1107/70 (OJ L 315, 3.12.2007, p. 1). (14) Commission Delegated Regulation (EU) 2017/1926 of 31 May 2017 supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to the provision of EU-wide multimodal travel information services (OJ L 272, 21.10.2017, p. 1). (15) Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (OJ L 165, 18.6.2013, p. 63). ANNEX I EXTRACT FROM THE UNIFORM RULES CONCERNING THE CONTRACT FOR INTERNATIONAL CARRIAGE OF PASSENGERS AND LUGGAGE BY RAIL (CIV) Appendix A to the Convention Concerning International Carriage by Rail (COTIF) of 9 May 1980, as modified by the Protocol for the modification of the Convention Concerning International Carriage by Rail of 3 June 1999 TITLE I GENERAL PROVISIONS Article 3 Definitions For purposes of these Uniform Rules, the term: (a) \u2018carrier\u2019 means the contractual carrier with whom the passenger has concluded the contract of carriage pursuant to these Uniform Rules, or a successive carrier who is liable on the basis of this contract; (b) \u2018substitute carrier\u2019 means a carrier, who has not concluded the contract of carriage with the passenger, but to whom the carrier referred to in letter (a) has entrusted, in whole or in part, the performance of the carriage by rail; (c) \u2018General Conditions of Carriage\u2019 means the conditions of the carrier in the form of general conditions or tariffs legally in force in each Member State and which have become, by the conclusion of the contract of carriage, an integral part of it; (d) \u2018vehicle\u2019 means a motor vehicle or a trailer carried on the occasion of the carriage of passengers. TITLE II CONCLUSION AND PERFORMANCE OF THE CONTRACT OF CARRIAGE Article 6 Contract of carriage 1. By the contract of carriage the carrier shall undertake to carry the passenger as well as, where appropriate, luggage and vehicles to the place of destination and to deliver the luggage and vehicles at the place of destination. 2. The contract of carriage must be confirmed by one or more tickets issued to the passenger. However, subject to Article 9 the absence, irregularity or loss of the ticket shall not affect the existence or validity of the contract which shall remain subject to these Uniform Rules. 3. The ticket shall be prima facie evidence of the conclusion and the contents of the contract of carriage. Article 7 Ticket 1. The General Conditions of Carriage shall determine the form and content of tickets as well as the language and characters in which they are to be printed and made out. 2. The following, at least, must be entered on the ticket: (a) the carrier or carriers; (b) a statement that the carriage is subject, notwithstanding any clause to the contrary, to these Uniform Rules; this may be indicated by the acronym CIV; (c) any other statement necessary to prove the conclusion and contents of the contract of carriage and enabling the passenger to assert the rights resulting from this contract. 3. The passenger must ensure, on receipt of the ticket, that it has been made out in accordance with his instructions. 4. The ticket shall be transferable if it has not been made out in the passenger\u2019s name and if the journey has not begun. 5. The ticket may be established in the form of electronic data registration, which can be transformed into legible written symbols. The procedure used for the registration and treatment of data must be equivalent from the functional point of view, particularly so far as concerns the evidential value of the ticket represented by those data. Article 8 Payment and refund of the carriage charge 1. Subject to a contrary agreement between the passenger and the carrier, the carriage charge shall be payable in advance. 2. The General Conditions of Carriage shall determine under what conditions a refund of the carriage charge shall be made. Article 9 Right to be carried. Exclusion from carriage 1. The passenger must, from the start of his journey, be in possession of a valid ticket and produce it on the inspection of tickets. The General Conditions of Carriage may provide: (a) that a passenger who does not produce a valid ticket must pay, in addition to the carriage charge, a surcharge; (b) that a passenger who refuses to pay the carriage charge or the surcharge upon demand may be required to discontinue his journey; (c) if and under what conditions a refund of the surcharge shall be made. 2. The General Conditions of Carriage may provide that passengers who: (a) present a danger for safety and the good functioning of the operations or for the safety of other passengers; (b) inconvenience other passengers in an intolerable manner, shall be excluded from carriage or may be required to discontinue their journey and that such persons shall not be entitled to a refund of their carriage charge or of any charge for the carriage of registered luggage they may have paid. Article 10 Completion of administrative formalities The passenger must comply with the formalities required by customs or other administrative authorities. Article 11 Cancellation and late running of trains. Missed connections The carrier must, where necessary, certify on the ticket that the train has been cancelled or the connection missed. TITLE III CARRIAGE OF HAND LUGGAGE, ANIMALS, REGISTERED LUGGAGE AND VEHICLES CHAPTER I Common provisions Article 12 Acceptable articles and animals 1. The passenger may take with him articles which can be handled easily (hand luggage) and also live animals in accordance with the General Conditions of Carriage. Moreover, the passenger may take with him cumbersome articles in accordance with the special provisions, contained in the General Conditions of Carriage. Articles and animals likely to annoy or inconvenience passengers or cause damage shall not be allowed as hand luggage. 2. The passenger may consign articles and animals as registered luggage in accordance with the General Conditions of Carriage. 3. The carrier may allow the carriage of vehicles on the occasion of the carriage of passengers in accordance with special provisions, contained in the General Conditions of Carriage. 4. The carriage of dangerous goods as hand luggage, registered luggage as well as in or on vehicles which, in accordance with this Title are carried by rail, must comply with the Regulation concerning the Carriage of Dangerous Goods by Rail (RID). Article 13 Examination 1. When there is good reason to suspect a failure to observe the conditions of carriage, the carrier shall have the right to examine whether the articles (hand luggage, registered luggage, vehicles including their loading) and animals carried comply with the conditions of carriage, unless the laws and prescriptions of the State in which the examination would take place prohibit such examination. The passenger must be invited to attend the examination. If he does not appear or cannot be reached, the carrier must require the presence of two independent witnesses. 2. If it is established that the conditions of carriage have not been respected, the carrier can require the passenger to pay the costs arising from the examination. Article 14 Completion of administrative formalities The passenger must comply with the formalities required by customs or other administrative authorities when, on being carried, he has articles (hand luggage, registered luggage, vehicles including their loading) or animals carried. He shall be present at the inspection of these articles save where otherwise provided by the laws and prescriptions of each State. CHAPTER II Hand luggage and animals Article 15 Supervision It shall be the passenger\u2019s responsibility to supervise the hand luggage and animals that he takes with him. CHAPTER III Registered luggage Article 16 Consignment of registered luggage 1. The contractual obligations relating to the forwarding of registered luggage must be established by a luggage registration voucher issued to the passenger. 2. Subject to Article 22 the absence, irregularity or loss of the luggage registration voucher shall not affect the existence or the validity of the agreements concerning the forwarding of the registered luggage, which shall remain subject to these Uniform Rules. 3. The luggage registration voucher shall be prima facie evidence of the registration of the luggage and the conditions of its carriage. 4. Subject to evidence to the contrary, it shall be presumed that when the carrier took over the registered luggage it was apparently in a good condition, and that the number and the mass of the items of luggage corresponded to the entries on the luggage registration voucher. Article 17 Luggage registration voucher 1. The General Conditions of Carriage shall determine the form and content of the luggage registration voucher as well as the language and characters in which it is to be printed and made out. Article 7(5) shall apply mutatis mutandis. 2. The following, at least, must be entered on the luggage registration voucher: (a) the carrier or carriers; (b) a statement that the carriage is subject, notwithstanding any clause to the contrary, to these Uniform Rules; this may be indicated by the acronym CIV; (c) any other statement necessary to prove the contractual obligations relating to the forwarding of the registered luggage and enabling the passenger to assert the rights resulting from the contract of carriage. 3. The passenger must ensure, on receipt of the luggage registration voucher, that it has been made out in accordance with his instructions. Article 18 Registration and carriage 1. Save where the General Conditions of Carriage otherwise provide, luggage shall be registered only on production of a ticket valid at least as far as the destination of the luggage. In other respects the registration of luggage shall be carried out in accordance with the prescriptions in force at the place of consignment. 2. When the General Conditions of Carriage provide that luggage may be accepted for carriage without production of a ticket, the provisions of these Uniform Rules determining the rights and obligations of the passenger in respect of his registered luggage shall apply mutatis mutandis to the consignor of registered luggage. 3. The carrier can forward the registered luggage by another train or by another mode of transport and by a different route from that taken by the passenger. Article 19 Payment of charges for the carriage of registered luggage Subject to a contrary agreement between the passenger and the carrier, the charge for the carriage of registered luggage shall be payable on registration. Article 20 Marking of registered luggage The passenger must indicate on each item of registered luggage in a clearly visible place, in a sufficiently durable and legible manner: (a) his name and address; (b) the place of destination. Article 21 Right to dispose of registered luggage 1. If circumstances permit and if customs requirements or the requirements of other administrative authorities are not thereby contravened, the passenger can request luggage to be handed back at the place of consignment on surrender of the luggage registration voucher and, if the General Conditions of Carriage so require, on production of the ticket. 2. The General Conditions of Carriage may contain other provisions concerning the right to dispose of registered luggage, in particular modifications of the place of destination and the possible financial consequences to be borne by the passenger. Article 22 Delivery 1. Registered luggage shall be delivered on surrender of the luggage registration voucher and, where appropriate, on payment of the amounts chargeable against the consignment. The carrier shall be entitled, but not obliged, to examine whether the holder of the voucher is entitled to take delivery. 2. It shall be equivalent to delivery to the holder of the luggage registration voucher if, in accordance with the prescriptions in force at the place of destination: (a) the luggage has been handed over to the customs or octroi authorities at their premises or warehouses, when these are not subject to the carrier\u2019s supervision; (b) live animals have been handed over to third parties. 3. The holder of the luggage registration voucher may require delivery of the luggage at the place of destination as soon as the agreed time and, where appropriate, the time necessary for the operations carried out by customs or other administrative authorities, has elapsed. 4. Failing surrender of the luggage registration voucher, the carrier shall only be obliged to deliver the luggage to the person proving his right thereto; if the proof offered appears insufficient, the carrier may require security to be given. 5. Luggage shall be delivered at the place of destination for which it has been registered. 6. The holder of a luggage registration voucher whose luggage has not been delivered may require the day and time to be endorsed on the voucher when he requested delivery in accordance with paragraph 3. 7. The person entitled may refuse to accept the luggage if the carrier does not comply with his request to carry out an examination of the registered luggage in order to establish alleged damage. 8. In all other respects delivery of luggage shall be carried out in accordance with the prescriptions in force at the place of destination. CHAPTER IV Vehicles Article 23 Conditions of carriage The special provisions governing the carriage of vehicles, contained in the General Conditions of Carriage, shall specify in particular the conditions governing acceptance for carriage, registration, loading and carriage, unloading and delivery as well as the obligations of the passenger. Article 24 Carriage voucher 1. The contractual obligations relating to the carriage of vehicles must be established by a carriage voucher issued to the passenger. The carriage voucher may be integrated into the passenger\u2019s ticket. 2. The special provisions governing the carriage of vehicles, contained in the General Conditions of Carriage, shall determine the form and content of the carriage voucher as well as the language and the characters in which it is to be printed and made out. Article 7(5) shall apply mutatis mutandis. 3. The following, at least, must be entered on the carriage voucher: (a) the carrier or carriers; (b) a statement that the carriage is subject, notwithstanding any clause to the contrary, to these Uniform Rules; this may be indicated by the acronym CIV; (c) any other statement necessary to prove the contractual obligations relating to the carriage of vehicles and enabling the passenger to assert the rights resulting from the contract of carriage. 4. The passenger must ensure, on receipt of the carriage voucher, that it has been made out in accordance with his instructions. Article 25 Applicable law Subject to the provisions of this Chapter, the provisions of Chapter III relating to the carriage of luggage shall apply to vehicles. TITLE IV LIABILITY OF THE CARRIER CHAPTER I Liability in case of death of, or personal injury to, passengers Article 26 Basis of liability 1. The carrier shall be liable for the loss or damage resulting from the death of, personal injuries to, or any other physical or mental harm to, a passenger, caused by an accident arising out of the operation of the railway and happening while the passenger is in, entering or alighting from railway vehicles whatever the railway infrastructure used. 2. The carrier shall be relieved of this liability: (a) if the accident has been caused by circumstances not connected with the operation of the railway and which the carrier, in spite of having taken the care required in the particular circumstances of the case, could not avoid and the consequences of which he was unable to prevent; (b) to the extent that the accident is due to the fault of the passenger; (c) if the accident is due to the behaviour of a third party which the carrier, in spite of having taken the care required in the particular circumstances of the case, could not avoid and the consequences of which he was unable to prevent; another undertaking using the same railway infrastructure shall not be considered as a third party; the right of recourse shall not be affected. 3. If the accident is due to the behaviour of a third party and if, in spite of that, the carrier is not entirely relieved of his liability in accordance with paragraph 2, letter (c), he shall be liable in full up to the limits laid down in these Uniform Rules but without prejudice to any right of recourse which the carrier may have against the third party. 4. These Uniform Rules shall not affect any liability which may be incurred by the carrier in cases not provided for in paragraph 1. 5. If carriage governed by a single contract of carriage is performed by successive carriers, the carrier bound pursuant to the contract of carriage to provide the service of carriage in the course of which the accident happened shall be liable in case of death of, and personal injuries to, passengers. When this service has not been provided by the carrier, but by a substitute carrier, the two carriers shall be jointly and severally liable in accordance with these Uniform Rules. Article 27 Damages in case of death 1. In case of death of the passenger the damages shall comprise: (a) any necessary costs following the death, in particular those of transport of the body and the funeral expenses; (b) if death does not occur at once, the damages provided for in Article 28. 2. If, through the death of the passenger, persons whom he had, or would have had, a legal duty to maintain are deprived of their support, such persons shall also be compensated for that loss. Rights of action for damages of persons whom the passenger was maintaining without being legally bound to do so, shall be governed by national law. Article 28 Damages in case of personal injury In case of personal injury or any other physical or mental harm to the passenger the damages shall comprise: (a) any necessary costs, in particular those of treatment and of transport; (b) compensation for financial loss, due to total or partial incapacity to work, or to increased needs. Article 29 Compensation for other bodily harm National law shall determine whether and to what extent the carrier must pay damages for bodily harm other than that for which there is provision in Articles 27 and 28. Article 30 Form and amount of damages in case of death and personal injury 1. The damages under Article 27(2) and Article 28(b) must be awarded in the form of a lump sum. However, if national law permits payment of an annuity, the damages shall be awarded in that form if so requested by the injured passenger or by the persons entitled referred to in Article 27(2). 2. The amount of damages to be awarded pursuant to paragraph 1 shall be determined in accordance with national law. However, for the purposes of these Uniform Rules, the upper limit per passenger shall be set at 175 000 units of account as a lump sum or as an annual annuity corresponding to that sum, where national law provides for an upper limit of less than that amount. Article 31 Other modes of transport 1. Subject to paragraph 2, the provisions relating to the liability of the carrier in case of death of, or personal injury to, passengers shall not apply to loss or damage arising in the course of carriage which, in accordance with the contract of carriage, was not carriage by rail. 2. However, where railway vehicles are carried by ferry, the provisions relating to liability in case of death of, or personal injury to, passengers shall apply to loss or damage referred to in Article 26(1) and Article 33(1), caused by an accident arising out of the operation of the railway and happening while the passenger is in, entering or alighting from the said vehicles. 3. When, because of exceptional circumstances, the operation of the railway is temporarily suspended and the passengers are carried by another mode of transport, the carrier shall be liable pursuant to these Uniform Rules. CHAPTER II Liability in case of failure to keep to the timetable Article 32 Liability in case of cancellation, late running of trains or missed connections 1. The carrier shall be liable to the passenger for loss or damage resulting from the fact that, by reason of cancellation, the late running of a train or a missed connection, his journey cannot be continued the same day, or that a continuation of the journey the same day could not reasonably be required because of given circumstances. The damages shall comprise the reasonable costs of accommodation as well as the reasonable costs occasioned by having to notify persons expecting the passenger. 2. The carrier shall be relieved of this liability, when the cancellation, late running or missed connection is attributable to one of the following causes: (a) circumstances not connected with the operation of the railway which the carrier, in spite of having taken the care required in the particular circumstances of the case, could not avoid and the consequences of which he was unable to prevent; (b) fault on the part of the passenger; or (c) the behaviour of a third party which the carrier, in spite of having taken the care required in the particular circumstances of the case, could not avoid and the consequences of which he was unable to prevent; another undertaking using the same railway infrastructure shall not be considered as a third party; the right of recourse shall not be affected. 3. National law shall determine whether and to what extent the carrier must pay damages for harm other than that provided for in paragraph 1. This provision shall be without prejudice to Article 44. CHAPTER III Liability in respect of hand luggage, animals, registered luggage and vehicles Section 1 Hand luggage and animals Article 33 Liability 1. In case of death of, or personal injury to, passengers the carrier shall also be liable for the loss or damage resulting from the total or partial loss of, or damage to, articles which the passenger had on him or with him as hand luggage; this shall apply also to animals which the passenger had brought with him. Article 26 shall apply mutatis mutandis. 2. In other respects, the carrier shall not be liable for the total or partial loss of, or damage to, articles, hand luggage or animals the supervision of which is the responsibility of the passenger in accordance with Article 15, unless this loss or damage is caused by the fault of the carrier. The other Articles of Title IV, with exception of Article 51, and Title VI shall not apply in this case. Article 34 Limit of damages in case of loss of or damage to articles When the carrier is liable under Article 33(1), he must pay compensation up to a limit of 1 400 units of account per passenger. Article 35 Exclusion of liability The carrier shall not be liable to the passenger for loss or damage arising from the fact that the passenger does not conform to the formalities required by customs or other administrative authorities. Section 2 Registered luggage Article 36 Basis of liability 1. The carrier shall be liable for loss or damage resulting from the total or partial loss of, or damage to, registered luggage between the time of taking over by the carrier and the time of delivery as well as from delay in delivery. 2. The carrier shall be relieved of this liability to the extent that the loss, damage or delay in delivery was caused by a fault of the passenger, by an order given by the passenger other than as a result of the fault of the carrier, by an inherent defect in the registered luggage or by circumstances which the carrier could not avoid and the consequences of which he was unable to prevent. 3. The carrier shall be relieved of this liability to the extent that the loss or damage arises from the special risks inherent in one or more of the following circumstances: (a) the absence or inadequacy of packing; (b) the special nature of the luggage; (c) the consignment as luggage of articles not acceptable for carriage. Article 37 Burden of proof 1. The burden of proving that the loss, damage or delay in delivery was due to one of the causes specified in Article 36(2) shall lie on the carrier. 2. When the carrier establishes that, having regard to the circumstances of a particular case, the loss or damage could have arisen from one or more of the special risks referred to in Article 36(3), it shall be presumed that it did so arise. The person entitled shall, however, have the right to prove that the loss or damage was not attributable either wholly or in part to one of those risks. Article 38 Successive carriers If carriage governed by a single contract is performed by several successive carriers, each carrier, by the very act of taking over the luggage with the luggage registration voucher or the vehicle with the carriage voucher, shall become a party to the contract of carriage in respect of the forwarding of luggage or the carriage of vehicles, in accordance with the terms of the luggage registration voucher or of the carriage voucher and shall assume the obligations arising therefrom. In such a case each carrier shall be responsible for the carriage over the entire route up to delivery. Article 39 Substitute carrier 1. Where the carrier has entrusted the performance of the carriage, in whole or in part, to a substitute carrier, whether or not in pursuance of a right under the contract of carriage to do so, the carrier shall nevertheless remain liable in respect of the entire carriage. 2. All the provisions of these Uniform Rules governing the liability of the carrier shall apply also to the liability of the substitute carrier for the carriage performed by him. Articles 48 and 52 shall apply if an action is brought against the servants or any other persons whose services the substitute carrier makes use of for the performance of the carriage. 3. Any special agreement under which the carrier assumes obligations not imposed by these Uniform Rules or waives rights conferred by these Uniform Rules shall be of no effect in respect of the substitute carrier who has not accepted it expressly and in writing. Whether or not the substitute carrier has accepted it, the carrier shall nevertheless remain bound by the obligations or waivers resulting from such special agreement. 4. Where and to the extent that both the carrier and the substitute carrier are liable, their liability shall be joint and several. 5. The aggregate amount of compensation payable by the carrier, the substitute carrier and their servants and other persons whose services they make use of for the performance of the carriage shall not exceed the limits provided for in these Uniform Rules. 6. This Article shall not prejudice rights of recourse which may exist between the carrier and the substitute carrier. Article 40 Presumption of loss 1. The person entitled may, without being required to furnish further proof, consider an item of luggage as lost when it has not been delivered or placed at his disposal within 14 days after a request for delivery has been made in accordance with Article 22(3). 2. If an item of luggage deemed to have been lost is recovered within one year after the request for delivery, the carrier must notify the person entitled if his address is known or can be ascertained. 3. Within thirty days after receipt of a notification referred to in paragraph 2, the person entitled may require the item of luggage to be delivered to him. In that case he must pay the charges in respect of carriage of the item from the place of consignment to the place where delivery is effected and refund the compensation received less, where appropriate, any costs included therein. Nevertheless he shall retain his rights to claim compensation for delay in delivery provided for in Article 43. 4. If the item of luggage recovered has not been claimed within the period stated in paragraph 3 or if it is recovered more than one year after the request for delivery, the carrier shall dispose of it in accordance with the laws and prescriptions in force at the place where the item of luggage is situated. Article 41 Compensation for loss 1. In case of total or partial loss of registered luggage, the carrier must pay, to the exclusion of all other damages: (a) if the amount of the loss or damage suffered is proved, compensation equal to that amount but not exceeding 80 units of account per kilogram of gross mass short or 1 200 units of account per item of luggage; (b) if the amount of the loss or damage suffered is not established, liquidated damages of 20 units of account per kilogram of gross mass short or 300 units of account per item of luggage. The method of compensation, by kilogram missing or by item of luggage, shall be determined by the General Conditions of Carriage. 2. The carrier must in addition refund the charge for the carriage of luggage and the other sums paid in relation to the carriage of the lost item as well as the customs duties and excise duties already paid. Article 42 Compensation for damage 1. In case of damage to registered luggage, the carrier must pay compensation equivalent to the loss in value of the luggage, to the exclusion of all other damages. 2. The compensation shall not exceed: (a) if all the luggage has lost value through damage, the amount which would have been payable in case of total loss; (b) if only part of the luggage has lost value through damage, the amount which would have been payable had that part been lost. Article 43 Compensation for delay in delivery 1. In case of delay in delivery of registered luggage, the carrier must pay in respect of each whole period of 24 hours after delivery has been requested, but subject to a maximum of 14 days: (a) if the person entitled proves that loss or damage has been suffered thereby, compensation equal to the amount of the loss or damage, up to a maximum of 0,80 units of account per kilogram of gross mass of the luggage or 14 units of account per item of luggage, delivered late; (b) if the person entitled does not prove that loss or damage has been suffered thereby, liquidated damages of 0,14 units of account per kilogram of gross mass of the luggage or 2,80 units of account per item of luggage, delivered late. The methods of compensation, by kilogram missing or by item of luggage, shall be determined by the General Conditions of Carriage. 2. In case of total loss of luggage, the compensation provided for in paragraph 1 shall not be payable in addition to that provided for in Article 41. 3. In case of partial loss of luggage, the compensation provided for in paragraph 1 shall be payable in respect of that part of the luggage which has not been lost. 4. In case of damage to luggage not resulting from delay in delivery the compensation provided for in paragraph 1 shall, where appropriate, be payable in addition to that provided for in Article 42. 5. In no case shall the total of compensation provided for in paragraph 1 together with that payable under Articles 41 and 42 exceed the compensation which would be payable in case of total loss of the luggage. Section 3 Vehicles Article 44 Compensation for delay 1. In case of delay in loading for a reason attributable to the carrier or delay in delivery of a vehicle, the carrier must, if the person entitled proves that loss or damage has been suffered thereby, pay compensation not exceeding the amount of the carriage charge. 2. If, in case of delay in loading for a reason attributable to the carrier, the person entitled elects not to proceed with the contract of carriage, the carriage charge shall be refunded to him. In addition the person entitled may, if he proves that loss or damage has been suffered as a result of the delay, claim compensation not exceeding the carriage charge. Article 45 Compensation for loss In case of total or partial loss of a vehicle the compensation payable to the person entitled for the loss or damage proved shall be calculated on the basis of the usual value of the vehicle. It shall not exceed 8 000 units of account. A loaded or unloaded trailer shall be considered as a separate vehicle. Article 46 Liability in respect of other articles 1. In respect of articles left inside the vehicle or situated in boxes (e.g. luggage or ski boxes) fixed to the vehicle, the carrier shall be liable only for loss or damage caused by his fault. The total compensation payable shall not exceed 1 400 units of account. 2. So far as concerns articles stowed on the outside of the vehicle, including the boxes referred to in paragraph 1, the carrier shall be liable in respect of articles placed on the outside of the vehicle only if it is proved that the loss or damage results from an act or omission, which the carrier has committed either with intent to cause such a loss or damage or recklessly and with knowledge that such loss or damage would probably result. Article 47 Applicable law Subject to the provisions of this Section, the provisions of Section 2 relating to liability for luggage shall apply to vehicles. CHAPTER IV Common provisions Article 48 Loss of right to invoke the limits of liability The limits of liability provided for in these Uniform Rules as well as the provisions of national law, which limit the compensation to a fixed amount, shall not apply if it is proved that the loss or damage results from an act or omission, which the carrier has committed either with intent to cause such loss or damage, or recklessly and with knowledge that such loss or damage would probably result. Article 49 Conversion and interest 1. Where the calculation of compensation requires the conversion of sums expressed in foreign currency, conversion shall be at the exchange rate applicable on the day and at the place of payment of the compensation. 2. The person entitled may claim interest on compensation, calculated at five per cent per annum, from the day of the claim provided for in Article 55 or, if no such claim has been made, from the day on which legal proceedings were instituted. 3. However, in the case of compensation payable pursuant to Articles 27 and 28, interest shall accrue only from the day on which the events relevant to the assessment of the amount of compensation occurred, if that day is later than that of the claim or the day when legal proceedings were instituted. 4. In the case of luggage, interest shall only be payable if the compensation exceeds 16 units of account per luggage registration voucher. 5. In the case of luggage, if the person entitled does not submit to the carrier, within a reasonable time allotted to him, the supporting documents required for the amount of the claim to be finally settled, no interest shall accrue between the expiry of the time allotted and the actual submission of such documents. Article 50 Liability in case of nuclear incidents The carrier shall be relieved of liability pursuant to these Uniform Rules for loss or damage caused by a nuclear incident when the operator of a nuclear installation or another person who is substituted for him is liable for the loss or damage pursuant to the laws and prescriptions of a State governing liability in the field of nuclear energy. Article 51 Persons for whom the carrier is liable The carrier shall be liable for his servants and other persons whose services he makes use of for the performance of the carriage, when these servants and other persons are acting within the scope of their functions. The managers of the railway infrastructure on which the carriage is performed shall be considered as persons whose services the carrier makes use of for the performance of the carriage. Article 52 Other actions 1. In all cases where these Uniform Rules shall apply, any action in respect of liability, on whatever grounds, may be brought against the carrier only subject to the conditions and limitations laid down in these Uniform Rules. 2. The same shall apply to any action brought against the servants and other persons for whom the carrier is liable pursuant to Article 51. TITLE V LIABILITY OF THE PASSENGER Article 53 Special principles of liability The passenger shall be liable to the carrier for any loss or damage: (a) resulting from failure to fulfil his obligations pursuant to: 1. Articles 10, 14 and 20; 2. the special provisions for the carriage of vehicles, contained in the General Conditions of Carriage; or 3. the Regulation concerning the International Carriage of Dangerous Goods by Rail (RID); or (b) caused by articles and animals that he brings with him, unless he proves that the loss or damage was caused by circumstances that he could not avoid and the consequences of which he was unable to prevent, despite the fact that he exercised the diligence required of a conscientious passenger. This provision shall not affect the liability of the carrier pursuant to Articles 26 and 33(1). TITLE VI ASSERTION OF RIGHTS Article 54 Ascertainment of partial loss or damage 1. When partial loss of, or damage to, an article carried in the charge of the carrier (luggage, vehicles) is discovered or presumed by the carrier or alleged by the person entitled, the carrier must without delay, and if possible in the presence of the person entitled, draw up a report stating, according to the nature of the loss or damage, the condition of the article and, as far as possible, the extent of the loss or damage, its cause and the time of its occurrence. 2. A copy of the report must be supplied free of charge to the person entitled. 3. Should the person entitled not accept the findings in the report, he may request that the condition of the luggage or vehicle and the cause and amount of the loss or damage be ascertained by an expert appointed either by the parties to the contract of carriage or by a court or tribunal. The procedure to be followed shall be governed by the laws and prescriptions of the State in which such ascertainment takes place. Article 55 Claims 1. Claims relating to the liability of the carrier in case of death of, or personal injury to, passengers must be addressed in writing to the carrier against whom an action may be brought. In the case of a carriage governed by a single contract and performed by successive carriers the claims may also be addressed to the first or the last carrier as well as to the carrier having his principal place of business or the branch or agency which concluded the contract of carriage in the State where the passenger is domiciled or habitually resident. 2. Other claims relating to the contract of carriage must be addressed in writing to the carrier specified in Article 56(2) and (3). 3. Documents which the person entitled thinks fit to submit with the claim shall be produced either in the original or as copies, where appropriate, the copies duly certified if the carrier so requires. On settlement of the claim, the carrier may require the surrender of the ticket, the luggage registration voucher and the carriage voucher. Article 56 Carriers against whom an action may be brought 1. An action based on the liability of the carrier in case of death of, or personal injury to, passengers may only be brought against the carrier who is liable pursuant to Article 26(5). 2. Subject to paragraph 4 other actions brought by passengers based on the contract of carriage may be brought only against the first carrier, the last carrier or the carrier having performed the part of carriage on which the event giving rise to the proceedings occurred. 3. When, in the case of carriage performed by successive carriers, the carrier who must deliver the luggage or the vehicle is entered with his consent on the luggage registration voucher or the carriage voucher, an action may be brought against him in accordance with paragraph 2 even if he has not received the luggage or the vehicle. 4. An action for the recovery of a sum paid pursuant to the contract of carriage may be brought against the carrier who has collected that sum or against the carrier on whose behalf it was collected. 5. An action may be brought against a carrier other than those specified in paragraphs 2 and 4 when instituted by way of counter-claim or by way of exception in proceedings relating to a principal claim based on the same contract of carriage. 6. To the extent that these Uniform Rules apply to the substitute carrier, an action may also be brought against him. 7. If the plaintiff has a choice between several carriers, his right to choose shall be extinguished as soon as he brings an action against one of them; this shall also apply if the plaintiff has a choice between one or more carriers and a substitute carrier. Article 58 Extinction of right of action in case of death or personal injury 1. Any right of action by the person entitled based on the liability of the carrier in case of death of, or personal injury to, passengers shall be extinguished if notice of the accident to the passenger is not given by the person entitled, within 12 months of his becoming aware of the loss or damage, to one of the carriers to whom a claim may be addressed in accordance with Article 55(1). Where the person entitled gives oral notice of the accident to the carrier, the carrier shall furnish him with an acknowledgement of such oral notice. 2. Nevertheless, the right of action shall not be extinguished if: (a) within the period provided for in paragraph 1 the person entitled has addressed a claim to one of the carriers designated in Article 55(1); (b) within the period provided for in paragraph 1 the carrier who is liable has learned of the accident to the passenger in some other way; (c) notice of the accident has not been given, or has been given late, as a result of circumstances not attributable to the person entitled; (d) the person entitled proves that the accident was caused by fault on the part of the carrier. Article 59 Extinction of right of action arising from carriage of luggage 1. Acceptance of the luggage by the person entitled shall extinguish all rights of action against the carrier arising from the contract of carriage in case of partial loss, damage or delay in delivery. 2. Nevertheless, the right of action shall not be extinguished: (a) in case of partial loss or damage, if: 1. the loss or damage was ascertained in accordance with Article 54 before the acceptance of the luggage by the person entitled; 2. the ascertainment which should have been carried out in accordance with Article 54 was omitted solely through the fault of the carrier; (b) in case of loss or damage which is not apparent whose existence is ascertained after acceptance of the luggage by the person entitled, if he: 1. asks for ascertainment in accordance with Article 54 immediately after discovery of the loss or damage and not later than three days after the acceptance of the luggage; and 2. in addition, proves that the loss or damage occurred between the time of taking over by the carrier and the time of delivery; (c) in case of delay in delivery, if the person entitled has, within twenty-one days, asserted his rights against one of the carriers specified in Article 56(3); (d) if the person entitled proves that the loss or damage was caused by fault on the part of the carrier. Article 60 Limitation of actions 1. The period of limitation of actions for damages based on the liability of the carrier in case of death of, or personal injury to, passengers shall be: (a) in the case of a passenger, three years from the day after the accident; (b) in the case of other persons entitled, three years from the day after the death of the passenger, subject to a maximum of five years from the day after the accident. 2. The period of limitation for other actions arising from the contract of carriage shall be one year. Nevertheless, the period of limitation shall be two years in the case of an action for loss or damage resulting from an act or omission committed either with the intent to cause such loss or damage, or recklessly and with knowledge that such loss or damage would probably result. 3. The period of limitation provided for in paragraph 2 shall run for actions: (a) for compensation for total loss, from the fourteenth day after the expiry of the period of time provided for in Article 22(3); (b) for compensation for partial loss, damage or delay in delivery, from the day when delivery took place; (c) in all other cases involving the carriage of passengers, from the day of expiry of validity of the ticket. The day indicated for the commencement of the period of limitation shall not be included in the period. 4. Otherwise, the suspension and interruption of periods of limitation shall be governed by national law. TITLE VII RELATIONS BETWEEN CARRIERS Article 61 Apportionment of the carriage charge 1. Any carrier who has collected or ought to have collected a carriage charge must pay to the carriers concerned their respective shares of such a charge. The methods of payment shall be fixed by agreement between the carriers. 2. Article 6(3), Article 16(3) and Article 25 shall also apply to the relations between successive carriers. Article 62 Right of recourse 1. A carrier who has paid compensation pursuant to these Uniform Rules shall have a right of recourse against the carriers who have taken part in the carriage in accordance with the following provisions: (a) the carrier who has caused the loss or damage shall be solely liable for it; (b) when the loss or damage has been caused by several carriers, each shall be liable for the loss or damage he has caused; if such distinction is impossible, the compensation shall be apportioned between them in accordance with letter (c); (c) if it cannot be proved which of the carriers has caused the loss or damage, the compensation shall be apportioned between all the carriers who have taken part in the carriage, except those who prove that the loss or damage was not caused by them; such apportionment shall be in proportion to their respective shares of the carriage charge. 2. In the case of insolvency of any one of these carriers, the unpaid share due from him shall be apportioned among all the other carriers who have taken part in the carriage, in proportion to their respective shares of the carriage charge. Article 63 Procedure for recourse 1. The validity of the payment made by the carrier exercising a right of recourse pursuant to Article 62 may not be disputed by the carrier against whom the right to recourse is exercised, when compensation has been determined by a court or tribunal and when the latter carrier, duly served with notice of the proceedings, has been afforded an opportunity to intervene in the proceedings. The court or tribunal seized of the principal action shall determine what time shall be allowed for such notification of the proceedings and for intervention in the proceedings. 2. A carrier exercising his right of recourse must present his claim in one and the same proceedings against all the carriers with whom he has not reached a settlement, failing which he shall lose his right of recourse in the case of those against whom he has not taken proceedings. 3. The court or tribunal shall give its decision in one and the same judgment on all recourse claims brought before it. 4. The carrier wishing to enforce his right of recourse may bring his action in the courts or tribunals of the State on the territory of which one of the carriers participating in the carriage has his principal place of business, or the branch or agency which concluded the contract of carriage. 5. When the action must be brought against several carriers, the plaintiff carrier shall be entitled to choose the court or tribunal in which he will bring the proceedings from among those having competence pursuant to paragraph 4. 6. Recourse proceedings may not be joined with proceedings for compensation taken by the person entitled under the contract of carriage. Article 64 Agreements concerning recourse The carriers may conclude agreements which derogate from Articles 61 and 62. ANNEX II MINIMUM INFORMATION TO BE PROVIDED BY RAILWAY UNDERTAKINGS AND TICKET VENDORS Part I: Pre-journey information General conditions applicable to the contract Time schedules and conditions for the fastest trip Time schedules and conditions for all available fares, highlighting the lowest fares Accessibility, access conditions and availability on board of facilities for persons with disabilities and persons with reduced mobility in accordance with Directive (EU) 2019/882 and Regulations (EU) No 454/2011 and (EU) No 1300/2014 Availability of capacity and access conditions for bicycles Availability of seats in first and second class as well as couchette cars and sleeping carriages Disruptions and delays (planned and in real time) Availability of on-board facilities, including Wi-Fi and toilets, and of on-board services, including the assistance passengers are provided with by staff Information prior to purchase on whether the ticket or the tickets constitute a through-ticket Procedures for reclaiming lost luggage Procedures for the submission of complaints Part II: Information during the journey On-board services and facilities, including Wi-Fi Next station Disruptions and delays (planned and in real time) Main connecting services Security and safety issues Part III: Operations regarding reservation systems Requests for availability of rail transport services, including applicable tariffs Requests for reservation of rail transport services Requests for partial or full cancellation of a reservation ANNEX III MINIMUM SERVICE QUALITY STANDARDS Information and tickets Punctuality of services, and general principles to cope with disruptions to services Delays (i) overall average delay of services as a percentage per category of service (long-distance, regional and urban/suburban); (ii) percentage of delays caused by circumstances referred to in Article 19(10); (iii) percentage of services delayed at departure; (iv) percentage of services delayed at arrival: \u2014 percentage of delays of less than 60 minutes; \u2014 percentage of delays of 60-119 minutes; \u2014 percentage of delays of 120 minutes or more; Cancellations of services (i) cancellation of services as a percentage per category of service (international, domestic long-distance, regional and urban/suburban); (ii) cancellation of services as a percentage per category of service (international, domestic long-distance, regional and urban/suburban) caused by circumstances referred to in Article 19(10). Cleanliness of rolling stock and station facilities (air quality and temperature control in carriages, hygiene of sanitary facilities, etc.) Customer satisfaction survey Complaint handling, refunds and compensation for non-compliance with service quality standards Assistance provided to persons with disabilities and persons with reduced mobility, and discussions concerning this assistance with representative organisations and, where relevant, representatives of persons with disabilities and persons with reduced mobility ANNEX IV CORRELATION TABLE Regulation (EC) No 1371/2007 This Regulation Article 1 Article 1 Article 1(a) Article 1(a) Article 1(b) Article 1(b) \u2014 Article 1(c) Article 1(c) Article 1(d) \u2014 Article 1(e) Article 1(d) Article 1(f) Article 1(e) Article 1(g) \u2014 Article 1(h) Article 1(f) Article 1(i) Article 2 Article 2 Article 2(1) Article 2(1) Article 2(2) \u2014 Article 2(3) \u2014 Article 2(4) \u2014 Article 2(5) Article 2(6)(a), (8) Article 2(6) Article 2(6)(b) Article 2(7) Article 2(7) \u2014 Article 2(2) \u2014 Article 2(3) \u2014 Article 2(4) \u2014 Article 2(5) Article 3 Article 3 Article 3(1) Article 3(1) Article 3(2), (3) \u2014 Article 3(4) Article 3(2) Article 3(5) Article 3(3) Article 3(6) Article 3(4) Article 3(7) Article 3(5) Article 3(8) Article 3(6) \u2014 Article 3(7) Article 3(9) Article 3(8) Article 3(10) Article 3(9) \u2014 Article 3(10) \u2014 Article 3(11) Article 3(11) Article 3(12) \u2014 Article 3(13) \u2014 Article 3(14) \u2014 Article 3(15) \u2014 Article 3(16) Article 3(12) Article 3(17) \u2014 Article 3(18) Article 3(13) Article 3(19) \u2014 Article 3(20) Article 3(15) Article 3(21) \u2014 Article 3(22) Article 4 Article 4 \u2014 Article 5 Article 5 Article 6 Article 6 Article 7 Article 7 Article 8 Article 8 Article 9 \u2014 Article 10 Article 9 Article 11 \u2014 Article 12 Article 11 Article 13 Article 12 Article 14 Article 13 Article 15 Article 14 Article 16 Article 15 Article 17 Article 16 Article 18 \u2014 Article 18(2), (3), (4), (5), (6), (7) Article 17(1) Article 19(1), (2), (3), (4) \u2014 Article 19(5), (6) Article 17(2) Article 19(7) Article 17(3) Article 19(8) Article 17(4) Article 19(9) \u2014 Article 19(10) Article 18 Article 20 \u2014 Article 20(6) Article 19 Article 21 Article 20 Article 22 Article 21(1) \u2014 Article 21(2) Article 23(1)(g) Article 22, Article 23 Article 23 Article 22(2) \u2014 Article 24 Article 24 Article 25 Article 25(1), (2), (3) \u2014 Article 26 Article 26 Article 27 Article 27 Article 28 \u2014 Article 28(3) Article 27(3) Article 28(4) Article 28 Article 29 Article 29 Article 30 Article 30 Article 31 \u2014 Article 32, 33 Article 31 Article 34 \u2014 Article 34(1), (3) Article 32 Article 35 \u2014 Article 35(2) Article 33 \u2014 Article 34 Article 36 Article 35 Article 38 \u2014 Article 37 Article 36 Article 39 \u2014 Article 40 Article 37 Article 41 Annex I Annex I Annex II Annex II Annex III Annex III \u2014 Annex IV", "summary": "EU rail passengers\u2019 rights EU rail passengers\u2019 rights SUMMARY OF: Regulation (EU) 2021/782 on rail passengers\u2019 rights and obligations WHAT IS THE AIM OF THE REGULATION? It aims to provide significantly improved protection to rail passengers in the event of travel disruptions. It also aims to respond better to the needs of persons with disabilities or reduced mobility. KEY POINTS The regulation applies to international or domestic rail journeys throughout the European Union (EU) provided by one or more railway companies. It includes a number of new and important features. Through-tickets. A new obligation for carriers qualifying as a \u2018sole railway undertaking\u2019* to offer their long-distance (international and domestic) and regional rail services as a through-ticket. Real-time travel information. Infrastructure managers shall distribute real-time traffic data to railway undertakings, ticket vendors, tour operators and station managers. Railway companies must provide real-time dynamic travel information to other railway companies selling their tickets, as well as to ticket vendors and tour operators. Right to self-routing. Where passengers have not been offered a timely solution (within 100 minutes) in the event of a disruption to their journey, they can themselves organise alternative public transportation by rail or bus, and be reimbursed by the carrier for the \u2018necessary, appropriate and reasonable\u2019 cost of the additional ticket. Transporting bicycles. Dedicated spaces for assembled (not merely folding) bicycles will be required on new trains and on those which have had major upgrades. Persons with disabilities or reduced mobility. Reduces the pre-notification period for assistance requests to 24 hours along with a number of other measures. Enforcing passengers\u2019 rights. Introduces an improved enforcement framework including: an amended complaint-handling mechanism;a reinforced obligation for cooperation between the national enforcement bodies;a standardised EU-wide form allowing passengers to request reimbursement or compensation. Force majeure clause. Railway undertakings do not have to pay compensation for delays or cancellation in the case of extraordinary circumstances such as a pandemic or extreme weather conditions. Equal treatment. Discrimination based on the passenger\u2019s nationality or the place of establishment within the EU of the carrier or the ticket vendor and tour operator is prohibited. Major disruptions. In coordination with infrastructure and station managers, railway undertakings should prepare contingency plans (including accessible alert and information systems) to prepare for the possibility of major disruption and long delays causing a considerable number of passengers to be stranded in a station. Exemptions. Previously existing exemptions are curtailed and no rail services are per se exempted. Certain exemptions can still be granted by EU Member States, such as for urban, suburban and regional passenger services, to which an increased number of mandatory provisions would then remain applicable. FROM WHEN DOES THE REGULATION APPLY? It enters into force on 6 June 2021 and applies from 7 June 2023. BACKGROUND Passenger rights \u2014 rail (European Commission). KEY TERMS Sole undertaking: the \u2018sole railway undertaking\u2019 may include different railway undertakings which are closely interlinked based on a 100% ownership criterion (Article 12 (1)). MAIN DOCUMENT Regulation (EU) 2021/782 of the European Parliament and of the Council of 29 April 2021 on rail passengers\u2019 rights and obligations (recast) (OJ L 172, 17.5.2021, pp. 1-52) RELATED DOCUMENTS Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, pp. 70-115) Commission Regulation (EU) No 1300/2014 of 18 November 2014 on the technical specifications for interoperability relating to accessibility of the Union\u2019s rail system for persons with disabilities and persons with reduced mobility (OJ L 356, 12.12.2014, pp. 110-178) Successive amendments to Regulation (EU) No 1300/2014 have been incorporated into the original text. This consolidated version is of documentary value only. Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, pp. 32-77) See consolidated version. Regulation (EC) No 1371/2007 of the European Parliament and of the Council of 23 October 2007 on rail passengers\u2019 rights and obligations (OJ L 315, 3.12.2007, pp. 14-41) last update 19.07.2021"}
{"article": "20.9.2021 EN Official Journal of the European Union L 330/1 REGULATION (EU) 2021/1529 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 September 2021 establishing the Instrument for Pre-Accession assistance (IPA III) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 212(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Regulation (EU) No 231/2014 of the European Parliament and of the Council (4) expired on 31 December 2020. In order to maintain the Union\u2019s effectiveness in external action, a framework for planning and delivering external assistance should be maintained for the period between 2021 and 2027. (2) The objective of an instrument for pre-accession assistance is to prepare beneficiaries for future membership of the Union and to support their accession process. It is therefore essential to have a dedicated instrument for pre-accession assistance to the beneficiaries listed in Annex I for the 2021-2027 period (IPA III) in support of enlargement, while ensuring that its objectives and functioning are consistent with, and complementary to, the general objectives of Union external action as laid down in Article 21 of the Treaty on European Union (TEU), including respect for fundamental rights and principles as well as the protection and promotion of human rights, democracy and the rule of law. This instrument should also be complementary with the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe (NDICI) established under Regulation (EU) 2021/947 of the European Parliament and of the Council (5). (3) Article 49 TEU provides that any European State which respects the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities, and is committed to promoting those values may apply to become a member of the Union. Those values are common to Member States in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail. (4) A European State which has applied to join the Union can become a member of the Union only where it has been confirmed that it fully meets the accession criteria established at the Copenhagen European Council in June 1993 (the \u2018Copenhagen criteria\u2019) and provided that the Union has the capacity to integrate the new member. The Copenhagen criteria relate to the stability of institutions which guarantee democracy, the rule of law, human rights and respect for and protection of minorities, the existence of a functioning market economy as well as the capacity to cope with competitive pressure and market forces within the Union, and the ability to assume not only the rights but also the obligations under the Treaties, including the pursuit of the aims of political, economic and monetary union. (5) The enlargement policy of the Union is a strategic investment in peace, security, stability and prosperity in Europe and allows the Union to be better positioned to address global challenges. It also provides increased economic and trade opportunities to the mutual benefit of the Union and the aspiring Member States, while ensuring a gradual transformation of the beneficiaries. The prospect of Union membership has a powerful transformative effect, embedding positive democratic, political, economic and societal change. (6) The enlargement process is built on established criteria and fair and rigorous conditionality. Each beneficiary is assessed on its own merits. The assessment of progress achieved and the identification of shortcomings aim to provide incentives and guidance to the beneficiaries listed in Annex I to pursue the necessary far-reaching reforms. For the prospect of enlargement to become a reality, a firm commitment to \u2018fundamentals first\u2019 remains essential. The \u2018fundamentals first\u2019 approach links the rule of law and fundamental rights with the two other crucial areas of the accession process: economic governance \u2013 strengthened focus on economic development and improved competitiveness \u2013 and the strengthening of democratic institutions and public administration reform. Each of the three fundamentals is of crucial importance for the reform processes in the beneficiaries listed in Annex I and addresses key concerns of the people. Progress towards accession depends on each applicant\u2019s respect for the Union\u2019s values and its capacity to undertake and implement the necessary reforms to align its political, institutional, legal, administrative and economic systems with the rules, standards, policies and practices of the Union. (7) Good neighbourly relations and regional cooperation are essential elements of the enlargement process and are critical for security and stability of the Union as a whole. The definitive, inclusive and binding resolution of bilateral disputes is also important. (8) Embracing and committing to core European values is a choice, and is essential for all partners aspiring to Union membership. In line with this, the partners should take ownership and fully commit to European values as well as to upholding a global order based on rules and values and vigorously pursuing the necessary reforms in the interest of their people. This includes progressive alignment with the Union\u2019s common foreign and security policy, in particular on issues where major common interests are at stake, such as restrictive measures and tackling disinformation and other hybrid threats. (9) The Commission emphasised the firm, merit-based prospect of Union membership for the Western Balkans in its communication of 6 February 2018 entitled \u2018A credible enlargement perspective for and enhanced EU engagement with the Western Balkans\u2019. On 5 February 2020, the Commission presented a revised methodology for the accession process in its communication entitled \u2018Enhancing the accession process \u2013 A credible EU perspective for the Western Balkans\u2019, which was endorsed by the Council. The Commission also presented an economic and investment plan for the Western Balkans for their recovery over the longer term following the COVID-19 crisis. (10) The Union and its Member States, in the Sofia Declaration of 17 May 2018 and the Zagreb Declaration of 6 May 2020, reaffirmed their unequivocal support for the European perspective of the Western Balkans as well as their engagement at all levels to support the region\u2019s political, economic and social transformation. In the Zagreb Declaration, the Union and its Member States reiterated their strong solidarity with the Western Balkans partners, in particular in the context of the COVID-19 crisis. (11) The European Council has granted the status of candidate country to the Republic of Albania, Iceland, Montenegro, the Republic of North Macedonia, the Republic of Serbia and the Republic of Turkey. It confirmed the European perspective of the Western Balkans, based on the Stabilisation and Association Process which remains the common framework for relations with the Western Balkans. Without prejudice to positions on status or to any future decisions to be taken by the European Council or by the Council, those benefiting from such a European perspective which have not been granted candidate country status may be considered as potential candidates solely for the purposes of this Regulation. In March 2015, the Government of Iceland asked the Union to no longer consider Iceland a candidate country, without, however, officially withdrawing Iceland\u2019s membership application. (12) Assistance should also be provided in compliance with the agreements concluded by the Union with the beneficiaries listed in Annex I. Assistance under this Regulation should mainly focus on assisting the beneficiaries listed in Annex I to strengthen democratic institutions and the rule of law, reform the judiciary and public administration, respect fundamental rights, including those of persons belonging to minorities, and promote gender equality, tolerance, social inclusion and non-discrimination, including in relation to persons in vulnerable situations, children or persons with disabilities. It should also support the development of a social market economy in line with the key principles and rights set out in the European Pillar of Social Rights solemnly proclaimed and signed on 17 November 2017 by the European Parliament, the Council and the Commission (6). It should not support actions that contribute to any form of segregation or social exclusion. (13) As good neighbourly relations and regional cooperation are essential elements of the enlargement process, assistance should also continue the support for the efforts of the beneficiaries listed in Annex I to advance regional, macro-regional and cross-border cooperation and territorial development, including through the implementation of Union macro-regional strategies. Those programmes should further contribute to the high visibility of assistance in the Union and in the beneficiaries listed in Annex I. Assistance under this Regulation should also enhance beneficiaries\u2019 economic and social development and economic governance, foster economic integration with the Union single market, including customs cooperation, promote open and fair trade that underpins a smart, sustainable and inclusive growth agenda, including through the implementation of regional development and cohesion policies, agriculture and rural development policies, social and employment policies, including labour mobility, the development of the digital economy and society, and boost research and innovation, also in the context of the 2018 flagship initiative Digital Agenda for the Western Balkans. (14) Actions under IPA III should support reconciliation, peace-building and conflict prevention through mediation efforts, confidence-building measures and processes that promote justice, truth-seeking, reparations and guarantees of non-recurrence. (15) Assistance under this Regulation should be used to strengthen health security and preparedness for public health emergencies as well as to address, in complementarity with other Union instruments, the major economic shock generated by the COVID-19 outbreak and to mitigate its severe socioeconomic impact, by mobilising resources to accelerate the economic recovery of the region. (16) Special emphasis should be put on creating further opportunities for the youth, including for young professionals, while ensuring that such opportunities contribute to the socioeconomic development of the beneficiaries listed in Annex I. Assistance under this Regulation should also aim to tackle brain drain. (17) The Union\u2019s efforts to support reform progress in the beneficiaries listed in Annex I through funding under IPA III should be well communicated by those beneficiaries as well as by the Union. In that regard, the Union should enhance communication and campaign efforts in order to ensure visibility of funding under IPA III. (18) The Union should provide support to the transition towards accession for the benefit of the beneficiaries listed in Annex I, drawing on the experience of the Member States. Such cooperation should focus particularly on the sharing of experience that was acquired by the Member States during their own reform processes. (19) Strengthening the rule of law, including the independence of the judiciary, the fight against corruption, money laundering and organised crime, as well as transparency, good governance at all levels, and public administration reform, including in the fields of public procurement, competition and State aid, remain key challenges and are essential for beneficiaries to come closer to the Union and to prepare to fully assume the obligations of Union membership. In view of the longer-term nature of the reforms pursued in those areas and the need to build up track records, financial assistance under this Regulation should address those issues as early as possible. (20) In accordance with the principle of participatory democracy, the Commission should encourage the strengthening of parliamentary capacities, parliamentary oversight, democratic procedures and fair representation in each beneficiary listed in Annex I. (21) Enhanced strategic and operational cooperation between the Union and the beneficiaries listed in Annex I on security is pivotal to addressing effectively and efficiently the threats of security, organised crime and terrorism. (22) Cooperation on migration at international and regional level, including further consolidating border and migration management capacities, ensuring access to international protection, sharing relevant information, enhancing border control and efforts to tackle irregular migration, addressing forced displacement and fighting against trafficking in human beings and people smuggling, is an important aspect of cooperation between the Union and the beneficiaries listed in Annex I. (23) The communication capacities of the beneficiaries listed in Annex I should be enhanced in order to ensure public support for and understanding of Union values and the benefits and obligations of potential Union membership, while addressing disinformation. (24) It is necessary that the Union lead the transition to a healthy planet and a more connected world. The European Green Deal as set out in the Commission communication of 11 December 2019 provides a renewed commitment and a new strategic framework to achieve that global objective. The Union should use its influence, expertise and financial assistance to mobilise the beneficiaries listed in Annex I to join it on a sustainable path. This Regulation should therefore promote the green agenda by reinforcing environmental protection, contributing to the mitigation of climate change and increasing resilience to climate change, and accelerating the shift towards a low-carbon economy. (25) The beneficiaries listed in Annex I need to be better prepared to address global challenges, such as sustainable development and climate change, and to align with the Union\u2019s efforts to address those issues. Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (7) and the United Nations Sustainable Development Goals, IPA III should contribute to mainstreaming climate action in the Union\u2019s policies and to the achievement of an overall target of 30 % of Union budget expenditure supporting climate objectives and the ambition of 7,5 % of the budget reflecting biodiversity expenditures in 2024 and 10 % in 2026 and 2027, while taking into account the existing overlaps between climate and biodiversity goals. Actions under IPA III are expected to contribute 18 % of the overall financial envelope of IPA III to climate objectives, with the objective of increasing this percentage to 20 % by 2027. Relevant actions are to be identified during the preparation and implementation of IPA III, and the overall contribution from IPA III should be considered in the relevant evaluations and review processes. (26) Actions under IPA III should support the implementation of the United Nations 2030 Agenda for Sustainable Development adopted in September 2015 as a universal agenda, to which the Union and its Member States are fully committed and which all beneficiaries listed in Annex I have endorsed. In order to achieve those objectives, in addition to actions in which climate is one of the main objectives, actions under IPA III should, whenever possible, mainstream environmental sustainability and climate change objectives across all sectors, with particular attention to environmental protection and tackling cross-border pollution, and should pursue green growth in national and local strategies, including supporting sustainability criteria in public procurement. Actions under IPA III should be consistent with the principle of \u2018do no harm\u2019 and should comply with Union taxonomy to the extent possible, in particular to ensure the sustainability of investments in the Western Balkans and Turkey. (27) The implementation of this Regulation should be guided by the principles of gender equality and the empowerment of women and girls, and should seek to protect and promote women\u2019s and girls\u2019 rights in line with the EU Gender Action Plans and relevant Council conclusions and international conventions, including the Council conclusions on women, peace and security of 10 December 2018. Strengthening gender equality and the empowerment of women and girls in Union external action and increasing efforts to reach the minimum standards of performance indicated by the EU Gender Action Plans should lead to a gender-sensitive and transformative approach in the cooperation between the Union and the beneficiaries listed in Annex I. Gender equality should be reflected and mainstreamed throughout the implementation of this Regulation. (28) This Regulation lays down a financial envelope for the entire duration of IPA III, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (8), for the European Parliament and the Council during the annual budgetary procedure. (29) The Commission and the Member States should ensure the compliance, coherence, consistency and complementarity of their assistance, in particular through regular consultations and frequent exchanges of information during the different phases of the assistance cycle, including at local level. The necessary steps should also be taken to ensure better coordination and complementarity with other donors, including through regular consultations. The Commission should ensure that relevant stakeholders in the beneficiaries listed in Annex I, including civil society organisations and local and regional authorities, as appropriate, are duly consulted and have timely access to relevant information to allow them to play a meaningful role during the design and implementation of programmes and the related monitoring processes. The role of civil society should be enhanced in programmes implemented through government bodies and as a direct beneficiary of Union assistance. Likewise, Union assistance should also support human rights\u2019 defenders. (30) The priorities of the actions aimed at achieving objectives in the relevant policy areas supported under this Regulation should be set out in a programming framework established by the Commission for the duration of the Union multiannual financial framework for the 2021-2027 period (\u2018IPA programming framework\u2019). The IPA programming framework should be established in partnership with the beneficiaries listed in Annex I, in line with the overall policy framework and principles, as well as with the general and specific objectives laid down in this Regulation, and should take into due account relevant national strategies. The IPA programming framework should identify the areas to be supported through assistance with an indicative allocation for each area of support, including an estimate of climate-related expenditure. (31) It is in the common interest of the Union and the beneficiaries listed in Annex I to advance the efforts of those beneficiaries to reform their political, legal and economic systems with a view to Union membership. Assistance should be based both on a performance-based approach and the fair share principle, ensuring progress in all beneficiaries listed in Annex I. Assistance should be targeted and adjusted to their specific situations, taking into account any further efforts needed to meet the objectives of this Regulation. The needs and capacities of the beneficiaries listed in Annex I should be taken into account in accordance with the fair share principle in order to avoid a disproportionately low level of assistance as compared to other beneficiaries. Assistance under this Regulation should be differentiated in scope and intensity according to the performance of the beneficiaries listed in Annex I, in particular their commitment to and progress in implementing reforms, in particular in the field of the rule of law and fundamental rights, democratic institutions and public administration reform, economic development and competitiveness. (32) Where the relevant indicators show a significant regression or persistent lack of progress by a beneficiary listed in Annex I in the areas covered by the \u2018fundamentals first\u2019 approach, the scope and intensity of assistance should be modulated accordingly, without prejudice to the powers of the Council to adopt restrictive measures following a decision on the interruption or reduction, in part or completely, of economic and financial relations with one or more third countries in accordance with Article 215 of the Treaty on the Functioning of the European Union (TFEU) and without prejudice to the Commission\u2019s power to suspend payments or the implementation of financing agreements in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (9) (the \u2018Financial Regulation\u2019). Due consideration should be given to the respect by the beneficiaries of the principles of the United Nations Charter and international law. (33) The Commission should assess each year the implementation of the IPA programming framework, describing how the performance-based approach and the fair share principle were implemented. That assessment should also include the state of play of the level of funding for each objective, as well as for each beneficiary listed in Annex I. It should also allow the committee established by this Regulation to have adequate information to assist the Commission. (34) The Commission should ensure clear monitoring and evaluation mechanisms are in place in order to provide effective accountability and transparency in implementing the Union budget, and in order to ensure effective assessment of progress towards the achievement of this Regulation\u2019s objectives. Whenever possible and appropriate, the results of the Union\u2019s action should be monitored and evaluated on the basis of pre-defined, transparent, country-specific and measurable indicators, adapted to the specificities and objectives of IPA III. (35) The transition from the direct management of pre-accession funds by the Commission to indirect management by the beneficiaries should be progressive and in line with the respective capacities of those beneficiaries, having regard to principles of good governance. The Commission should take appropriate supervisory measures ensuring the protection of the financial interests of the Union, and be able, where necessary, to reverse that transition. Assistance should continue to make use of the structures and instruments that have proved their worth in the pre-accession process. (36) The Union should seek the most efficient use of available resources in order to optimise the impact of its external action. That should be achieved through coherence, consistency and complementarity with the Union\u2019s external financing instruments, as well as through synergies with other Union policies and programmes, such as Horizon Europe \u2013 the Framework Programme for Research and Innovation \u2013 established by Regulation (EU) 2021/695 of the European Parliament and of the Council (10), Erasmus+ established by Regulation (EU) 2021/817 of the European Parliament and of the Council (11), the Creative Europe Programme established by Regulation (EU) 2021/818 of the European Parliament and of the Council (12), the European Green Deal, the Just Transition Fund established by Regulation (EU) 2021/1056 of the European Parliament and of the Council (13) and the Connecting Europe Facility established by Regulation (EU) 2021/1153 of the European Parliament and of the Council (14), including, where relevant, coherence and complementarity with macro-financial assistance. (37) In order to maximise the impact of combined interventions to achieve a common objective, IPA III should be able to contribute to actions under other programmes, as long as the contributions do not cover the same costs. (38) Union funding under IPA III should be used to finance actions under the international dimension of Erasmus+, the implementation of which should be carried out in accordance with Regulation (EU) 2021/817. (39) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, prizes, procurement and indirect management, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (40) As the respect for democracy, human rights and the rule of law is essential for sound financial management and effective Union funding as referred to in the Financial Regulation, assistance could be suspended in the event of the degradation of democracy, human rights or the rule of law by a beneficiary listed in Annex I. (41) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, administrative burdens, and the expected risk of non-compliance. That should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (42) The Union should continue to apply common rules for the implementation of its external action. Rules and procedures for the implementation of the Union\u2019s instruments for financing external action are laid down in Regulation (EU) 2021/947. Additional detailed provisions should be laid down to address specific situations, in particular for cross-border cooperation, agriculture and rural development policy areas. (43) External actions are often implemented in a highly volatile environment that requires continuous and rapid adaptation to the evolving needs of Union partners and to global challenges such as human rights, democracy and good governance, security and stability, climate change and environment, irregular migration and forced displacement and their root causes. Reconciling the principle of predictability with the need to react rapidly to new needs consequently means adapting the financial implementation of the programmes. To increase the ability of the Union to respond to unforeseen needs, while respecting the principle that the Union budget is set annually, this Regulation should preserve the flexibility allowed under the Financial Regulation to other policies, namely carry-overs and re-commitments of committed funds, while adhering to the goals and objectives laid down in this Regulation. This will ensure the efficient use of Union funds, both for Union citizens and for the beneficiaries listed in Annex I, thereby maximising the Union funds available for the Union\u2019s external action interventions. (44) The new European Fund for Sustainable Development Plus (EFSD+) established by Regulation (EU) 2021/947, which builds on its predecessor, should constitute an integrated financial package supplying financing capacity in the form of grants, budgetary guarantees and other financial instruments worldwide, including to the beneficiaries listed in Annex I. The governance of the EFSD+ operations covering the Western Balkans carried out under this Regulation should be ensured by the Western Balkans Investment Framework (WBIF). The steering committee of the WBIF includes the beneficiaries from the Western Balkans listed in Annex I, the contributors to the European Western Balkans Joint Fund, relevant financial institutions and relevant regional organisations, as appropriate. The specific strategic board for the EFSD+ operations covering the Western Balkans should continue to be as inclusive. (45) The External Action Guarantee, established by Regulation (EU) 2021/947, supports the EFSD+ operations, and IPA III should contribute to the provisioning needs in respect of the operations to the benefit of the beneficiaries listed in Annex I, including the provisioning and liabilities arising from macro-financial assistance loans. (46) It is important to ensure that cross border cooperation programmes are implemented consistently with the framework established in the external action programmes and Regulation (EU) 2021/1059 of the European Parliament and of the Council (15). Specific co-financing provisions should be established in this Regulation. (47) Annual or multiannual action plans and measures referred to in this Regulation constitute work programmes under the Financial Regulation. Annual or multiannual action plans consist of a set of measures grouped into one document. (48) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (16) and Council Regulations (EC, Euratom) No 2988/95 (17), (Euratom, EC) No 2185/96 (18) and (EU) 2017/1939 (19), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (20). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. Beneficiaries listed in Annex I should also report the irregularities including fraud which have been the subject of a primary administrative or judicial finding, without delay, to the Commission and keep the latter informed of the progress of administrative and legal proceeding. With the objective of alignment to good practices in Member States, this reporting should be done by electronic means, using the Irregularity Management System, established by the Commission. (49) Assistance under this Regulation should be implemented in a transparent, accountable and depoliticised manner. The Commission should monitor this closely, including at local level. (50) Communication fosters democratic debate, reinforces institutional control and scrutiny over Union funding, and contributes to boosting the credibility of the Union. The Union and the beneficiaries of Union funding should enhance the visibility of Union actions, and should communicate adequately the added value of Union support. In that regard, in accordance with the Financial Regulation, agreements concluded with recipients of Union funding should contain obligations to ensure appropriate visibility, and the Commission should act in an appropriate and timely manner when those obligations are not met. (51) In order to take account of any changes in the enlargement policy framework or of significant developments in the beneficiaries listed in Annex I, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to adapt and update the thematic priorities for assistance listed in Annexes II and III as well as to adopt a delegated act to supplement this Regulation by setting out certain specific objectives and thematic priorities for assistance. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (21). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (52) In order to ensure uniform conditions for the implementation of this Regulation, in particular on specific conditions and structures for indirect management with the beneficiaries listed in Annex I and on the implementation of rural development assistance, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011of the European Parliament and of the Council (22). When establishing the uniform conditions for implementing this Regulation, the lessons learnt from the management and implementation of past pre-accession assistance should be taken into account. Those uniform conditions should be amended if developments so require. (53) The committee established under this Regulation should be competent also for legal acts and commitments under Council Regulation (EC) No 1085/2006 (23) and Regulation (EU) No 231/2014, as well as for the implementation of Article 3 of Council Regulation (EC) No 389/2006 (24). (54) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (55) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the multiannual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject matter This Regulation establishes the Instrument for Pre-accession Assistance (\u2018IPA III\u2019) for the period of the multiannual financial framework 2021-2027 (\u20182021-2027 MFF\u2019). It lays down the objectives of IPA III, the budget for the 2021-2027 period, the forms of Union assistance and the rules for providing such assistance. Article 2 Definition For the purpose of this Regulation, \u2018cross-border cooperation\u2019 means cooperation between: (a) Member States and beneficiaries listed in Annex I to this Regulation as referred to in Article 3(1), point (b), of Regulation (EU) 2021/1059; (b) two or more beneficiaries listed in Annex I to this Regulation; or (c) beneficiaries listed in Annex I to this Regulation and countries and territories listed in Annex I to Regulation (EU) 2021/947. Article 3 Objectives of IPA III 1. The general objective of IPA III is to support the beneficiaries listed in Annex I in adopting and implementing the political, institutional, legal, administrative, social and economic reforms required by those beneficiaries to comply with Union values and to progressively align to Union rules, standards, policies and practices (\u2018acquis\u2019) with a view to future Union membership, thereby contributing to mutual stability, security, peace and prosperity. 2. IPA III shall have the following specific objectives: (a) to strengthen the rule of law, democracy, the respect of human rights and fundamental freedoms, including through promoting an independent judiciary, reinforced security and the fight against corruption and organised crime, compliance with international law, freedom of media and academic freedom and an enabling environment for civil society, to promote non-discrimination and tolerance, to ensure respect for the rights of persons belonging to minorities and the promotion of gender equality and to improve migration management, including border management and tackling irregular migration, as well as addressing forced displacement; (b) to reinforce the effectiveness of public administration and to support transparency, structural reforms and good governance at all levels, including in the areas of public procurement and State aid; (c) to shape the rules, standards, policies and practices of the beneficiaries listed in Annex I in alignment with those of the Union and to reinforce regional cooperation, reconciliation and good neighbourly relations, as well as people-to-people contacts and strategic communication; (d) to strengthen economic and social development and cohesion, with particular attention to youth, including through quality education and employment policies, through supporting investment and private sector development, with a focus on small and medium-sized enterprises (SMEs), as well as on agriculture and rural development; (e) to reinforce environmental protection, to increase resilience to climate change, to accelerate the shift towards a low-carbon economy, to develop the digital economy and society and to strengthen sustainable connectivity in all its dimensions; (f) to support territorial cohesion and cross-border cooperation across land and maritime borders, including transnational and interregional cooperation. 3. In accordance with the specific objectives, assistance may, as appropriate, address the following thematic priorities: (a) establishing and promoting from an early stage the proper functioning of the institutions necessary to secure the rule of law and further consolidating democratic institutions; (b) strengthening capacities to face migration challenges at regional and international levels; (c) enhancing capacities for strategic communication, including communicating to the public about necessary reforms for meeting the Union\u2019s membership criteria; (d) enhancing good governance and reforming public administration in line with the principles of public administration; (e) strengthening fiscal and economic governance; (f) strengthening all aspects of good neighbourly relations, regional stability and mutual cooperation; (g) strengthening the capacity of the Union and its partners to prevent conflict, build peace and address pre- and post-crisis needs; (h) strengthening the capacities, independence and plurality of civil society organisations; (i) promoting the alignment of beneficiaries\u2019 rules, standards, policies and practices with those of the Union; (j) promoting gender equality and the empowerment of women and girls; (k) strengthening access to and the quality of education, training and lifelong learning at all levels, and offering support to cultural and creative sectors and sport; (l) fostering quality employment and access to the labour market; (m) promoting social protection and inclusion and combating poverty; (n) promoting smart, sustainable, inclusive and safe transport, removing bottlenecks in key network infrastructures, and enhancing energy security and diversification; (o) improving the private-sector environment and competitiveness of enterprises, in particular of SMEs; (p) improving access to digital technologies and services and strengthening research, technological development and innovation; (q) contributing to the security and safety of the supply of food and water; (r) protecting the environment and improving the quality of the environment; (s) cooperating with the beneficiaries listed in Annex I in the peaceful use of nuclear energy in the areas of health, agriculture and food safety; (t) increasing the ability of the agri-food and fisheries sectors to cope with competitive pressure and market forces. 4. With a view to promoting good neighbourly relations, fostering Union integration and promoting socioeconomic development, assistance for cross-border cooperation between the beneficiaries listed in Annex I may, as appropriate, address the following thematic priorities: (a) promoting employment, labour mobility and social and cultural inclusion across borders; (b) protecting the environment and promoting adaptation to climate change, the mitigation of climate change, and risk prevention and management; (c) promoting sustainable transport and improving public infrastructures; (d) promoting the digital economy and society; (e) encouraging tourism and preserving and promoting cultural and natural heritage; (f) investing in youth, sport, education and skills; (g) promoting local and regional governance; (h) promoting cross-border initiatives to foster reconciliation and transitional justice; (i) enhancing competitiveness, the business environment and the development of SMEs, trade and investment; (j) strengthening research, technological development, innovation and digital technologies. 5. The thematic priorities for providing assistance according to the needs and capacities of the beneficiaries listed in Annex I are further set out in Annex II. The thematic priorities for cross-border cooperation between beneficiaries listed in Annex I are further set out in Annex III. Each of those thematic priorities may contribute to the attainment of more than one specific objective. 6. The Commission is empowered to adopt, prior to the adoption of the IPA programming framework, a delegated act in accordance with Articles 14 and 15 in order to supplement this Regulation by setting out certain specific objectives and thematic priorities for assistance related to the matters referred to in paragraph 3, points (a) to (m) and point (r), and paragraph 4, points (a) to (j), of this Article. Article 4 Budget 1. The financial envelope for the implementation of IPA III for the 2021-2027 period shall be EUR 14 162 000 000 in current prices. 2. The amount referred to in paragraph 1 of this Article may be used to finance support measures for the implementation of IPA III, such as preparatory, monitoring, control, audit and evaluation activities, including corporate information technology systems, in accordance with Article 24 of Regulation (EU) 2021/947. Article 5 Cross-programme provisions 1. In implementing this Regulation, consistency, synergies and complementarities with other areas of the Union\u2019s external action and with other relevant Union policies and programmes, and policy coherence for development shall be ensured. 2. Regulation (EU) 2021/947 shall apply to activities implemented under this Regulation where it is referred to in this Regulation. 3. IPA III shall contribute funds to actions implemented and managed in accordance with Regulation (EU) 2021/817. Regulation (EU) 2021/817 applies to the use of those funds. To that end, the contribution of IPA III shall be included in the single programming document referred to in Article 13(6) of Regulation (EU) 2021/947 and adopted in accordance with the procedures laid down in that Regulation. That programming document shall contain an indicative minimum amount to be allocated to actions established under Regulation (EU) 2021/817. 4. Assistance under this Regulation may be provided to the type of actions provided for under the European Regional Development Fund and the Cohesion Fund the specific objectives and scope of support of which are set out in Regulation (EU) 2021/1058 of the European Parliament and of the Council (25), the European Social Fund Plus established by Regulation (EU) 2021/1057 of the European Parliament and of the Council (26) and the European Agricultural Fund for Rural Development to be established by a Regulation of the European Parliament and of the Council establishing rules on support for strategic plans to be drawn up by Member States under the Common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulation (EU) No 1305/2013 of the European Parliament and of the Council and Regulation (EU) No 1307/2013 of the European Parliament and of the Council. 5. The European Regional Development Fund shall contribute to programmes or measures established for cross-border cooperation between the beneficiaries listed in Annex I and one or more Member States. The Commission shall adopt those programmes and measures in accordance with Article 17(3) of this Regulation. The amount of the contribution from IPA III funds allocated to cross-border cooperation (\u2018IPA III-CBC\u2019), as referred to in Article 10(3) of Regulation (EU) 2021/1059, shall be determined in accordance with that Article. IPA III-CBC programmes shall be managed in accordance with Regulation (EU) 2021/1059. 6. IPA III may contribute to transnational and interregional cooperation programmes or measures that are established and implemented under Regulation (EU) 2021/1059, taking into account macro-regional strategies or sea basin strategies, where applicable, and in which the beneficiaries listed in Annex I to this Regulation participate. Where a transnational and interregional cooperation programme or measure is also supported by NDICI, pre-financing shall be paid in accordance with Article 22(5) of Regulation (EU) 2021/947. 7. Where appropriate, other Union programmes may contribute to actions established under this Regulation in accordance with Article 9, provided that the contributions do not cover the same costs. This Regulation may also contribute to measures established under other Union programmes, provided that the contributions do not cover the same costs. In such cases, the work programme covering those actions shall establish which set of rules shall be applicable. 8. To ensure the coherence and effectiveness of Union financing or to foster regional cooperation, the Commission may, where duly justified, decide to extend the eligibility of action plans and measures referred to in Article 9(1) to countries, territories or regions which would not otherwise be eligible for financing pursuant to Article 3(1), provided that the plan or measure to be implemented is of a global, regional or cross-border nature. CHAPTER II Strategic planning Article 6 Policy framework and general principles 1. The enlargement policy framework defined by the European Council and the Council, the agreements that establish a legally binding relationship with the beneficiaries listed in Annex I, as well as resolutions of the European Parliament, communications of the Commission and joint communications of the Commission and the High Representative of the Union for Foreign Affairs and Security Policy, shall constitute the overall policy framework for the implementation of this Regulation. The Commission shall ensure coherence between the assistance under this Regulation and the enlargement policy framework. 2. Programmes and actions under IPA III in pursuit of the specific objectives referred to in Article 3(2) shall mainstream the horizontal priorities of climate change, environmental protection, human rights and gender equality, in order to promote integrated actions that create co-benefits and meet multiple objectives in a coherent way. Where applicable, programmes and actions shall address interlinkages between Sustainable Development Goals, including the goals of promoting peaceful and inclusive societies, as well as of poverty reduction. 3. The Commission, in liaison with Member States, shall contribute to the implementation of Union commitments to increased transparency and accountability in the delivery of assistance, including by making information on assistance volume and allocation available through web-based databases, and shall ensure that data is comparable and can be easily accessed, shared and published. 4. The Commission and the Member States shall cooperate in ensuring coherence and shall strive to avoid duplication between assistance under this Regulation and other assistance provided by the Union, the Member States and the European Investment Bank Group, in line with the established principles for strengthening operational coordination in the field of external assistance, including through enhanced coordination with Member States at local level and through the harmonisation of policies and procedures, in particular the international principles on development effectiveness. Such coordination shall involve regular and timely consultations, frequent exchanges of information during the different phases of the assistance cycle, shall involve inclusive meetings aimed at coordinating the assistance, including at local level, and shall constitute a key step in the programming processes of the Union and the Member States. 5. In line with the principle of inclusive partnership, where appropriate, the Commission shall ensure that relevant stakeholders in the beneficiaries listed in Annex I, including civil society organisations and local and regional authorities, as appropriate, are duly consulted and have timely access to relevant information to allow them to play a meaningful role during the design and implementation of programmes and the related monitoring processes. The Commission shall encourage coordination among the relevant stakeholders. The capacities of civil society organisations shall be strengthened, including their capacities as direct beneficiaries of assistance, where appropriate. 6. The Commission, in liaison with the Member States, shall take the necessary steps to ensure coordination and complementarity with multilateral and regional organisations and entities, such as international organisations and financial institutions, and agencies and non-Union donors. CHAPTER III Implementation Article 7 IPA programming framework 1. Assistance under this Regulation shall be based on an IPA programming framework for the delivery of the specific objectives referred to in Article 3(2) and the thematic priorities referred to in Article 3(3) and further set out in Annexes II and III. The Commission shall establish the IPA programming framework for the duration of the 2021-2027 MFF. 2. The European Parliament and the Council shall authorise the annual appropriations within the limits of the 2021-2027 MFF. 3. The IPA programming framework shall be developed in accordance with the policy framework and general principles set out in Article 6 and shall take relevant national strategies and sector policies into due account. 4. The IPA programming framework shall include indicative allocations of Union funds for thematic areas in accordance with the specific objectives referred to in Article 3(2), as applicable, broken down by year, without prejudice to the possibility of combining assistance contributing to the achievement of different specific objectives. 5. The IPA programming framework shall include indicators for assessing progress towards the achievement of the specific objectives referred to in Article 3(2). Those indicators shall be coherent with the key performance indicators referred to in Annex IV. 6. The Commission shall carry out an annual assessment of the implementation of the IPA programming framework in light of the evolution of the policy framework referred to in Article 6 and based on the indicators referred to in paragraph 5 of this Article. That assessment shall also include the state of play of the allocations committed and planned for beneficiaries listed in Annex I and how the performance-based approach and the fair share principle referred to in Article 8 have been implemented. The Commission shall submit that assessment to the committee referred to in Article 17. 7. On the basis of the annual assessment referred to in paragraph 6, the Commission may propose to revise the IPA programming framework as appropriate. Furthermore, the Commission may review the IPA programming framework following the mid-term evaluation referred to in Article 42 of Regulation (EU) 2021/947 and, where appropriate, may revise it. Any revision of the IPA programming framework shall be carried out in accordance with the procedure referred to in paragraph 8. 8. Without prejudice to paragraph 9, the Commission shall adopt the IPA programming framework by means of an implementing act. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 17(3). 9. The Commission shall adopt the programming framework for cross-border cooperation with Member States in accordance with Article 17(3). Article 8 Assistance to beneficiaries, performance assessment and fair share principle 1. Assistance under this Regulation shall be based both on a performance-based approach and the fair share principle, as set out in paragraphs 2, 3 and 4. 2. Assistance shall aim to ensure progress with respect to all the beneficiaries listed in Annex I and shall be targeted and adjusted to their specific situations, taking into account any further efforts needed to meet the objectives of this Regulation. The needs and capacities of those beneficiaries shall be taken into account in accordance with the fair share principle in order to avoid a disproportionately low level of assistance as compared to other beneficiaries. 3. Assistance shall be differentiated in scope and intensity according to performance of the beneficiaries listed in Annex I, in particular as regards their commitment to and progress in implementing reforms, as well as according to their needs. 4. In assessing the performance of the beneficiaries listed in Annex I and deciding on the assistance to be provided, particular attention shall be paid to the efforts made in the fields of the rule of law and fundamental rights, democratic institutions and public administration reform, as well as economic development and competitiveness. 5. In the case of a significant regression or persistent lack of progress by a beneficiary listed in Annex I in the areas referred to in paragraph 4 of this Article as measured by the indicators referred to in Article 7(5), the scope and intensity of assistance shall be modulated accordingly, in accordance with paragraph 6, including by reducing the funds proportionally and redirecting them in ways that avoid compromising support for improving fundamental rights, democracy and the rule of law, including support to civil society and, where appropriate, cooperation with local authorities. Where progress has resumed, the assistance shall also be modulated accordingly in accordance with paragraph 6 to further support those efforts. 6. Assistance to the beneficiaries listed in Annex I shall be decided in the framework of measures referred to in Article 9. Article 9 Implementing measures and methods 1. Assistance under this Regulation shall be implemented in direct management or indirect management in accordance with the Financial Regulation through annual or multiannual action plans and measures as referred to in Chapter III of Title II of Regulation (EU) 2021/947. The Commission shall adopt, by means of implementing acts, action plans and measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(3). Chapter III of Title II of Regulation (EU) 2021/947 shall apply to this Regulation with the exception of Article 28(1) of that Regulation. 2. The transition from direct management by the Commission to indirect management by the beneficiaries listed in Annex I shall be progressive and in line with the respective capacities of those beneficiaries as well as with regard to principles of good governance. The Commission shall take appropriate supervisory measures ensuring the protection of the financial interests of the Union, as appropriate. The Commission may also reverse that transition in the event that a beneficiary listed in Annex I fails to fulfil relevant obligations, principles, objectives and rules established in the Financial Regulation. 3. The European Parliament may hold regular exchanges of views with the Commission regarding its own assistance programmes, on matters such as capacity-building, including related mediation and dialogue, and election observation. 4. Action plans under this Regulation may be adopted for a period of up to seven years. 5. Budget support shall be based on mutual accountability and a shared commitment to democracy, human rights and the rule of law, and shall be provided in accordance with Article 236 of the Financial Regulation and Article 27 of Regulation (EU) 2021/947. Actions under IPA III shall support the development of parliamentary control, audit capacities and increased transparency and public access to information. Article 10 Cross-border cooperation 1. Up to 3 % of the financial envelope shall be indicatively allocated to programmes for cross-border cooperation between the beneficiaries listed in Annex I and the Member States, in line with their needs and priorities. 2. The Union co-financing rate at the level of each priority shall not be higher than 85 % of the eligible expenditure of a cross-border cooperation programme. 3. The level of pre-financing for cross-border cooperation with Member States may exceed the percentage referred to in Article 51(3) of Regulation (EU) 2021/1059 and shall amount to 50 % of the first three budgetary commitments to the programme. 4. Where cross-border cooperation programmes are discontinued in accordance with Article 12 of Regulation (EU) 2021/1059, support under this Regulation to the discontinued programme that remains available may be used to finance other actions eligible under this Regulation. CHAPTER IV Eligibility Article 11 Eligibility for funding under IPA III Participation in procurement, grant and prize award procedures for actions financed under this Regulation shall be open to international and regional organisations and to all other natural persons who are nationals of, and to legal persons which are effectively established in: (a) Member States, beneficiaries listed in Annex I to this Regulation, contracting parties to the Agreement on the European Economic Area and countries covered by the Annex I to Regulation (EU) 2021/947; and (b) countries for which reciprocal access to external assistance is established by the Commission. For the purposes of point (b), reciprocal access may be granted, for a limited period of at least one year, where a country grants eligibility on equal terms to entities from the Union and from countries eligible under this Regulation. The Commission shall decide on the reciprocal access after consulting the recipient country or countries concerned. CHAPTER V EFSD+ and budgetary guarantees Article 12 Financial instruments and guarantee for external actions 1. In accordance with Article 31(7) of Regulation (EU) 2021/947, the beneficiaries listed in Annex I to this Regulation shall be eligible for support through the European Fund for Sustainable Development Plus (EFSD+) and the External Action Guarantee (EAG). EFSD+ and EAG operations shall be financed under this Regulation as provided for in Chapter IV of Title II of Regulation (EU) 2021/947 mutatis mutandis, subject to the special provisions of this Article. 2. The Commission shall be advised by a specific strategic board in the management of the EFSD+ operations for the Western Balkans (\u2018strategic board\u2019). 3. The strategic board shall advise the Commission on the strategic orientation of investments for the Western Balkans under EFSD+, and contribute to their alignment with the guiding principles, policy framework and objectives set out in this Regulation. The strategic board shall support the Commission in setting overall investment goals for the Western Balkans as regards the use of the EAG to support EFSD+ operations and shall monitor an appropriate and diversified thematic coverage for investment windows. 4. The strategic board shall include representatives of the Commission, all Member States and the European Investment Bank (EIB). The European Parliament shall have observer status. Participation in the strategic board may be open to other relevant stakeholders. The strategic board shall decide on the inclusion of any new member or observer. Without prejudice to specific arrangements on co-chairing, the strategic board shall be chaired by the Commission, and shall, to the extent possible, adopt opinions by consensus. Participation in the meetings of the strategic board shall be voluntary. 5. Before the first meeting of the strategic board, the Commission shall propose the rules of procedure for adoption by the strategic board, including rules on participation of representatives in the Western Balkans Investment Framework, the role of observers and on the designation of co-chairs. The minutes and agendas of the meetings of the strategic board shall be made public following their adoption. 6. The Commission shall report every year to the strategic board about the progress made in respect of the implementation of the operations covering the Western Balkans. CHAPTER VI Monitoring, reporting and evaluation Article 13 Monitoring, audit, evaluation and protection of the Union\u2019s financial interests 1. Article 41 of Regulation (EU) 2021/947 in relation to monitoring and reporting shall apply to this Regulation mutatis mutandis. The annual report referred to in Article 41(5) of Regulation (EU) 2021/947 shall also contain information on commitments and payments per instrument (IPA, IPA II and IPA III). 2. The key performance indicators for monitoring the implementation and progress of IPA III towards the achievement of the specific objectives set out in Article 3 are listed in Annex IV to this Regulation. 3. For cross-border cooperation with Member States, the indicators shall be those referred to in Article 34 of Regulation (EU) 2021/1059. 4. In addition to the indicators listed in Annex IV, the reports accompanying the annual Commission communication on the Union\u2019s enlargement policy and the Commission\u2019s assessments of the economic reform programmes shall be taken into account in the results framework of IPA III assistance. 5. In addition to the elements referred to in Article 41(5) and (6) of Regulation (EU) 2021/947, the annual report shall contain information on the commitments for specific objectives referred to in Article 3 of this Regulation. 6. Article 42 of Regulation (EU) 2021/947 in relation to the mid-term and the final evaluation shall apply mutatis mutandis. 7. In addition to Article 129 of the Financial Regulation on the protection of the financial interests of the Union, under indirect management, beneficiaries listed in Annex I to this Regulation shall report any irregularities, including fraud, which have been the subject of a primary administrative or judicial finding, without delay, to the Commission and shall keep the Commission informed of the progress of any administrative and legal proceedings in relation to such irregularities. Such reporting shall be done by electronic means, using the Irregularity Management System, established by the Commission. CHAPTER VII Final provisions Article 14 Delegation of power The Commission is empowered to adopt delegated acts in accordance with Article 15 to amend Annexes II, III and IV and a delegated act to supplement this Regulation in order to set out certain specific objectives and thematic priorities for assistance as referred to in Article 3(6). Article 15 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts as referred to in Article 14 shall be conferred on the Commission for the period of validity of this Regulation. 3. The delegation of power referred to in Article 14 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 14 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 16 Adoption of further implementing rules Specific rules establishing uniform conditions for implementing this Regulation, in particular in relation to the structures to be set up in preparation for accession and to rural development assistance, shall be adopted by the Commission in accordance with the examination procedure referred to in Article 17(3). Article 17 Committee procedure 1. The Commission shall be assisted by a committee for the Instrument for Pre-accession Assistance (the \u2018IPA III committee\u2019). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. The IPA III committee shall assist the Commission to fulfil the objectives referred to in Article 3 in light of the annual assessment provided by the Commission in accordance with Articles 7(6) and 13(5). 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. The rules of procedure of the IPA III committee shall provide for proportionate time limits allowing committee members early and effective opportunities to examine the draft implementing acts and express their views, in accordance with Article 3 of Regulation (EU) No 182/2011. 5. Where the opinion of the committee is to be obtained by a written procedure, that procedure shall be terminated without result when, within the time limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so requests. 6. An observer from the EIB shall take part in the IPA III committee\u2019s proceedings with regard to questions concerning the EIB. 7. The IPA III committee shall assist the Commission and shall be competent also for legal acts and commitments under Regulations (EC) No 1085/2006 and (EU) No 231/2014 and the implementation of Article 3 of Regulation (EC) No 389/2006. 8. The IPA III committee shall not be competent for the contribution to Erasmus+ as referred to in Article 5(3). Article 18 Information, communication and visibility 1. The recipients of Union funding under IPA III shall acknowledge the origin of, and ensure the visibility of, the Union funding, in particular when promoting and reporting on the actions and their results, by highlighting the support received from the Union and its benefits for people in a visible manner in communication materials related to the actions supported under this Regulation and by providing coherent, effective and proportionate targeted information to multiple audiences in a strategic manner, including to the media and the public. Agreements concluded with recipients of Union funding under IPA III shall contain obligations in that respect. Agreements concluded with beneficiaries listed in Annex I shall include the principles to be followed in visibility and communication activities and the objectives of those activities, and a clear obligation to actively publicise information about programmes and actions under IPA III. In order to improve the results of communication activities for cross-border cooperation programmes between the beneficiaries listed in Annex I, specific joint communication activities shall be planned. Actions under IPA III shall be carried out in accordance with communication and visibility requirements in Union-financed external actions and in other relevant guidelines. 2. The Commission shall carry out information and communication actions relating to IPA III and its actions and results, in particular at local and regional level, in order to ensure the visibility of the Union\u2019s financial assistance. Financial resources allocated under IPA III shall also contribute to the corporate communication of, and reporting on, the political priorities of the Union, as far as these priorities are directly related to the objectives referred to in Article 3. 3. IPA III shall support strategic communication and public diplomacy, including the fight against disinformation, with a view to communicating the Union\u2019s values as well as the added value of, and results achieved by the Union\u2019s actions. 4. The Commission shall make publicly available relevant information on all actions financed under this Regulation in accordance with Article 38 of the Financial Regulation, including as appropriate through a comprehensive single website. 5. Where security issues or political sensitivities may make it preferable or necessary to limit communication and visibility activities in certain countries or areas or during certain periods, the target audience and the visibility tools, products and channels to be used in promoting a given action shall be determined on a case-by-case basis, in consultation with and in agreement with the Union. Any such exceptions shall be duly justified and their scope shall be specified and limited in each case. Where rapid intervention is required in response to a sudden crisis, it shall not be necessary to produce a full communication and visibility plan immediately. In such situations, however, the Union\u2019s support shall nevertheless be appropriately indicated from the start. Article 19 Transitional provisions 1. This Regulation shall not affect the continuation or modification of actions under Regulations (EC) No 1085/2006 or (EU) No 231/2014, which shall continue to apply to those actions until their closure. Chapter III of Title II of Regulation (EU) 2021/947 shall apply to those actions, except for Article 28(1) and (3) thereof, instead of which Articles 8(4), 10(1) and 10(3) of Regulation (EU) No 236/2014 of the European Parliament and of the Council (27) shall apply. 2. The financial envelope for IPA III may also cover technical and administrative assistance expenses necessary to ensure the transition between the measures adopted under IPA II and under IPA III, as well as any activities related to the preparation of the successor programme for pre-accession assistance. 3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 4(2), to enable the management of actions not completed by 31 December 2027. Article 20 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 September 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. LOGAR (1) OJ C 110, 22.3.2019, p. 156. (2) OJ C 86, 7.3.2019, p. 295. (3) Position of the European Parliament of 27 March 2019 (OJ C 108, 26.3.2021, p. 409) and position of the Council at first reading of 7 September 2021 (not yet published in the Official Journal). Position of the European Parliament of 15 September 2021 (not yet published in the Official Journal). (4) Regulation (EU) No 231/2014 of the European Parliament and of the Council of 11 March 2014 establishing an Instrument for Pre-accession Assistance (IPA II) (OJ L 77, 15.3.2014, p. 11). (5) Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe, amending and repealing Decision No 466/2014/EU and repealing Regulation (EU) 2017/1601 and Council Regulation (EC, Euratom) No 480/2009 (OJ L 209, 14.6.2021, p. 1). (6) OJ C 428, 13.12.2017, p. 10. (7) OJ L 282, 19.10.2016, p. 4. (8) OJ L 433I, 22.12.2020, p. 28. (9) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (10) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (11) Regulation (EU) 2021/817 of the European Parliament and of the Council of 20 May 2021 establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 (OJ L 189, 28.5.2021, p. 1). (12) Regulation (EU) 2021/818 of the European Parliament and of the Council of 20 May 2021 establishing the Creative Europe Programme (2021 to 2027) and repealing Regulation (EU) No 1295/2013 (OJ L 189, 28.5.2021, p. 34). (13) Regulation (EU) 2021/1056 of the European Parliament and of the Council of 24 June 2021 establishing the Just Transition Fund (OJ L 231, 30.6.2021, p. 1). (14) Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (OJ L 249, 14.7.2021, p. 38). (15) Regulation (EU) 2021/1059 of the European Parliament and of the Council of 24 June 2021 on specific provisions for the European territorial cooperation goal (Interreg) supported by the European Regional Development Fund and external financing instruments (OJ L 231, 30.6.2021, p. 94). (16) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (17) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (18) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (19) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (20) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (21) OJ L 123, 12.5.2016, p. 1. (22) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (23) Council Regulation (EC) No 1085/2006 of 17 July 2006 establishing an Instrument for Pre-Accession Assistance (IPA) (OJ L 210, 31.7.2006, p. 82). (24) Council Regulation (EC) No 389/2006 of 27 February 2006 establishing an instrument of financial support for encouraging the economic development of the Turkish Cypriot community and amending Council Regulation (EC) No 2667/2000 on the European Agency for Reconstruction (OJ L 65, 7.3.2006, p. 5). (25) Regulation (EU) 2021/1058 of the European Parliament and of the Council of 24 June 2021 on the European Regional Development Fund and on the Cohesion Fund (OJ L 231, 30.6.2021, p. 60). (26) Regulation (EU) 2021/1057 of the European Parliament and of the Council of 24 June 2021 establishing the European Social Fund Plus (ESF+) and repealing Regulation (EU) No 1296/2013 (OJ L 231, 30.6.2021, p. 21). (27) Regulation (EU) No 236/2014 of the European Parliament and of the Council of 11 March 2014 laying down common rules and procedures for the implementation of the Union\u2019s instruments for financing external action (OJ L 77 15.3.2014, p. 95). ANNEX I The Republic of Albania Bosnia and Herzegovina Iceland Kosovo (*) Montenegro The Republic of North Macedonia The Republic of Serbia The Republic of Turkey (*) This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence. ANNEX II THEMATIC PRIORITIES FOR ASSISTANCE Assistance may, as appropriate, address the following thematic priorities: (a) Establishing and promoting from an early stage the proper functioning of the institutions necessary to secure the rule of law and further consolidating democratic institutions. Interventions in this area shall aim at: establishing independent, accountable, impartial, professional, depoliticised, and efficient judicial systems, including through transparent and merit-based recruitment, evaluation and promotion systems and effective disciplinary procedures in cases of wrongdoing, and promoting judicial cooperation; ensuring access to justice; promoting police cooperation and information exchange; developing effective tools to prevent and fight organised crime, trafficking in human beings and of small arms and light weapons, migrants smuggling, drug trafficking, money laundering/financing of terrorism and corruption; supporting engagement with the Union on counter-terrorism and preventing radicalisation; and promoting and protecting human rights, including non-discrimination and gender equality, the rights of the child, rights of persons belonging to minorities including national minorities and Roma, as well as rights of lesbian, gay, bisexual, transgender and intersex persons, and fundamental freedoms, including freedom of expression, freedom of the media, freedom of assembly and association and data protection. (b) Strengthening capacities to face migration challenges at regional and international level. Interventions in this area shall aim at: sharing relevant information, further consolidating border and migration management capacities, ensuring access to international protection, enhancing border control and efforts to tackle irregular migration and addressing forced displacement. (c) Enhancing capacities for strategic communication, including communicating to the public about necessary reforms for meeting the Union\u2019s membership criteria. Efforts in this area shall aim at supporting further development of independent and pluralistic media and media literacy and shall serve, inter alia, as a means of building capacities in the area of cyber-security and increasing state and societal resilience to disinformation and other forms of hybrid threats. (d) Enhancing good governance and reforming public administration in line with the principles of public administration. Interventions shall aim at: strengthening public administration reform frameworks, including in the field of public procurement, improving strategic planning and inclusive and evidence-based policy and legislative development; enhancing professionalisation and de-politicisation of public service by embedding meritocratic principles; promoting transparency and accountability; improving the quality and delivery of services, including adequate administrative procedures and the use of citizen-centred eGovernment; strengthening public financial management; and improving the production of good quality statistics. (e) Strengthening fiscal and economic governance. Interventions shall aim at: supporting the implementation of the economic reform programmes and systematic cooperation with international financial institutions on fundamentals of economic policy and strengthening of economic institutions; enhancing the capacity to strengthen macroeconomic stability and social cohesion; supporting sustainable development and progress towards becoming a functioning market economy with the capacity to cope with competitive pressures and market forces within the Union; and advancing towards the Common Regional Market. (f) Strengthening all aspects of good neighbourly relations, regional stability and mutual cooperation. (g) Strengthening the capacity of the Union and its partners to prevent conflict, build peace and address pre- and post-crisis needs, including through: early warning and conflict-sensitive risk analysis; promoting people to people networking, reconciliation, peace-building and confidence-building measures, initiatives promoting reconciliation, transitional justice, truth-seeking, reparations and guarantees of non-recurrence (such as RECOM); and supporting capacity building in support of security and development (CBSD) actions in accordance with Article 9 of Regulation (EU) 2021/947. (h) Strengthening the capacities, independence and plurality of civil society organisations and social partners\u2019 organisations, including professional associations, in beneficiaries listed in Annex I and encouraging networking at all levels among Union-based organisations and those of beneficiaries listed in Annex I, enabling them to engage in an effective dialogue with public and private actors. (i) Promoting the alignment of beneficiaries\u2019 rules, standards, policies and practices with those of the Union, including public procurement and State aid rules. (j) Promoting gender equality and the empowerment of women and girls. Interventions in this area shall aim at: establishing a more enabling environment for the fulfilment of women\u2019s and girls\u2019 rights and achieving real and tangible improvements in gender equality in strategic policy areas such as freedom from all forms of gender-based violence; sexual and reproductive health and rights; economic and social rights and the empowerment of women and girls; equal participation and leadership; women, peace and security; and the gender dimension of green and digital transformations, including through supporting gender budgeting. (k) Strengthening access to and the quality of education, training and lifelong learning at all levels, and offering support to cultural and creative sectors and sport. Interventions in this area shall aim at: promoting equal access to quality early childhood education and care, primary and secondary education; improving the provision of basic skills; increasing educational attainment levels; tackling brain drain; reducing early school-leaving; reinforcing teachers\u2019 training; empowering children and youth and enabling them to reach their full potential; developing vocational education and training systems and promoting work-based learning systems to facilitate the transition to the labour market, including for persons with disabilities; improving the quality and relevance of higher education and research; encouraging alumni-related activities; and enhancing access to lifelong learning and supporting investment in education and accessible training infrastructure, particularly with a view to reducing territorial disparities and fostering non-segregated inclusive education and including through the use of accessible digital technologies. (l) Fostering quality employment and access to the labour market. Interventions in this area shall aim at tackling high unemployment and inactivity by supporting sustainable labour market integration in particular of young people (especially those not in employment, education or training), women, long-term unemployed and all under-represented groups. Measures shall stimulate quality job creation and support the effective enforcement of labour rules and standards across the entire territory in line with the key principles and rights defined in the European Pillar of Social Rights. Other key areas of intervention shall be supporting gender equality and youth and promoting employability and productivity, the adaptation of workers and enterprises to change, the establishment of a sustainable social dialogue and the modernisation and strengthening of labour market institutions such as public employment services and labour inspectorates. (m) Promoting social protection and inclusion and combating poverty. Interventions in this area shall aim at modernising social protection systems to provide effective, efficient and adequate protection throughout all stages of a person\u2019s life, promoting the transition from institutional to family and community-based care, fostering social inclusion, promoting equal opportunities and addressing inequalities and poverty. Interventions in this area shall also focus on: integrating marginalised communities such as the Roma; combating discrimination based on sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation; and enhancing access to affordable, sustainable and high quality services, such as early childhood education and care, housing, healthcare and essential social services and long term care, including through the modernisation of social protection systems. (n) Promoting smart, sustainable, inclusive and safe transport, removing bottlenecks in key network infrastructures, and enhancing energy security and diversification, by investing in projects with high European added-value. The investments should be prioritised according to their relevance to TEN-T connections with the Union, cross-border links, job creation, contribution to sustainable mobility, reduced emissions, environmental impact and safe mobility, in synergy with the reforms promoted by the Transport Community Treaty. Interventions in the area of energy shall aim at increasing energy efficiency and sustainable production as well as diversifying supplier countries and routes. (o) Improving the private-sector environment and competitiveness of enterprises, in particular of SMEs, including smart specialisation, as key drivers of growth, job creation and cohesion. Priority shall be given to sustainable projects which improve the business environment. (p) Improving access to digital technologies and services and strengthening research, technological development and innovation by investing in digital connectivity, digital trust and security, digital skills and entrepreneurship, in capacity building in research and innovation systems, in mobility, in research infrastructure and in enabling environment and by promoting networking and collaboration. (q) Contributing to the security and safety of the supply of food and water and the maintenance of diversified and viable farming systems in vibrant rural communities and the countryside. (r) Protecting the environment and improving the quality of the environment, addressing environmental degradation and halting biodiversity loss, promoting the conservation and sustainable management of terrestrial and marine ecosystems and renewable natural resources, investing in air quality, water and waste management and sustainable chemical management, promoting resource efficiency, sustainable consumption and production and supporting the transition to green and circular economies, contributing to the reduction of greenhouse gas emissions, increasing resilience to climate change and promoting climate action governance and information and energy efficiency. IPA III shall promote policies to support the shift towards a resource-efficient, safe and sustainable low-carbon economy and strengthen disaster resilience as well as disaster prevention, preparedness and response. (s) Cooperating with the beneficiaries listed in Annex I in the peaceful use of nuclear energy in the areas of health, agriculture and food safety, ensuring full compliance with the highest international standards, as well as supporting actions addressing the consequences on the local population exposed to any radiological accident and aiming at improving their living conditions, and promoting knowledge-management, training and education in nuclear-related fields. Where applicable, these activities shall be coherent with those of the European Instrument for Nuclear Safety and in line with Regulation (EU) 2021/947. (t) Increasing the ability of the agri-food and fisheries sectors to cope with competitive pressure and market forces as well as to progressively align with the Union rules and standards, while pursuing economic, social and environmental goals in balanced territorial development of rural and coastal areas. ANNEX III THEMATIC PRIORITIES FOR ASSISTANCE FOR CROSS-BORDER COOPERATION BETWEEN BENEFICIARIES LISTED IN ANNEX I With a view to promoting good neighbourly relations, fostering Union integration and promoting socioeconomic development, assistance for cross-border cooperation may address the following thematic priorities, as appropriate: (a) promoting employment, labour mobility and social and cultural inclusion across borders through, inter alia: integrating cross-border labour markets, including cross-border mobility; joint local employment initiatives; information and advisory services and joint training; gender equality; equal opportunities; integration of immigrants\u2019 communities and vulnerable groups; investment in public employment services; and supporting investment in public health and social services; (b) protecting the environment and promoting adaptation to climate change, the mitigation of climate change, and risk prevention and management through, inter alia: joint actions for environmental protection; promoting sustainable use of natural resources, coordinated maritime spatial planning, resource efficiency and circular economy, renewable energy sources and the shift towards a safe and sustainable low-carbon, green economy; improving air and water quality, including by enhancing alignment with European environmental standards, and waste and water management; promoting investment to address specific risks; ensuring disaster resilience and disaster prevention, preparedness and response; and promoting and enhancing international coordination of transboundary rivers; (c) promoting sustainable transport and improving public infrastructures by, inter alia, reducing isolation through improved access to transport, digital networks and services and investing in cross-border water, waste and energy systems and facilities; (d) promoting the digital economy and society by, inter alia, the deployment of digital connectivity and the development of eGovernment services, digital trust and security as well as digital skills and entrepreneurship; (e) encouraging tourism, especially sustainable tourism, and preserving and promoting cultural and natural heritage; (f) investing in youth, sport, education and skills through, inter alia, developing and implementing joint education, vocational training, training schemes and infrastructure supporting joint youth activities; (g) promoting local and regional governance and enhancing the planning and administrative capacity of local and regional authorities; (h) promoting cross-border initiatives to foster reconciliation and transitional justice (such as RECOM); (i) enhancing competitiveness, the business environment and the development of SMEs, trade and investment through, inter alia, the promotion of and support to entrepreneurship, in particular in relation to SMEs, and the development of local cross-border markets and internationalisation, also contributing to the Common Regional Market; (j) strengthening research, technological development, innovation and digital technologies, inter alia, through promoting mobility and through the sharing of human resources and facilities for research and technology development. ANNEX IV LIST OF KEY PERFORMANCE INDICATORS The following list of key performance indicators shall be used to help measure the progress and, where appropriate, readiness by beneficiaries listed in Annex I and the Union\u2019s contribution to the achievement of the specific objectives of IPA III: 1. Composite indicator (1) on political criteria (source: European Commission). 2. Attitude towards the EU: Percentage of population with a positive general attitude towards the EU (source: European Commission/EU Delegations). 3. Composite indicator on Union acquis alignment (source: European Commission). 4. Composite indicator on economic criteria (source: European Commission). 5. Expenditure on social protection as % of GDP (source: Eurostat) and Employment Rate of persons aged 20 to 64 and changes in the Gini coefficient of a beneficiary over time (source: Eurostat). 6. Digital skills (source: Eurostat). 7. \u2018Ease of doing business\u2019 (source: World Bank). 8. Energy intensity measured in terms of primary energy and GDP (source: Eurostat). Share of renewable energy in gross final energy consumption % (source: Eurostat). 9. Greenhouse Gas (GHG) emissions avoided (tonnes CO2-eq) with IPA III support (source: European Commission). PM 10 concentrations compared to the EU daily limit value (50 \u03bcg/m3); (Source: European Environmental Agency). 10. Areas of marine, terrestrial and freshwater ecosystems under a) protection, b) sustainable management with IPA III support. 11. Good neighbourly relations, such as number of cross-border partnerships established, formalised and implemented, percentage of intra-regional trade to GDP (Source of data: National statistics, Regional Cooperation Council), number of persons crossing the border/day, and number of goods transporting vehicles crossing the border every day (2) (Source: Transport Observatory). Indicators will, where relevant and possible, and where data is available, be disaggregated by gender and age. (1) The indicator includes 5 elements: \u2014 Functioning of judiciary \u2014 Fighting against corruption \u2014 Fighting against organised crime \u2014 Freedom of expression (which is an element of fundamental rights) \u2014 Public administration reform. (2) Data on the latter to only be available from 2023 onwards.", "summary": "IPA III: the Instrument for Pre-Accession Assistance (2021\u20132027) IPA III: the Instrument for Pre-Accession Assistance (2021\u20132027) SUMMARY OF: Regulation (EU) 2021/1529 establishing the Instrument for Pre-Accession Assistance (IPA III) WHAT IS THE AIM OF THE REGULATION? The regulation establishes the Instrument for Pre-Accession Assistance (IPA III) for the period of the 2021\u20132027 multiannual financial framework (MFF). It sets out: the policy\u2019s general and specific objectives; the size, form and rules of European Union (EU) funding. KEY POINTS IPA III: covers Albania, Bosnia and Herzegovina, Iceland, Kosovo*, Montenegro, North Macedonia, Serbia and Turkey (Annex I); has the general objective of helping the IPA III beneficiaries align themselves with EU rules, standards, policies and practices to prepare for EU membership by promoting political, institutional, legal, administrative, social and economic reforms; identifies specific aims to: strengthen the rule of law, democracy, human rights and economic and social development,reinforce effective public administration, structural reforms and good governance,shape rules, standards, policies and practices,promote environmental protection and a low-carbon economy,support territorial cohesion and cross-border cooperation; contains 20 thematic priorities, ranging from gender equality and quality employment to smart transport and safe food and water supplies (Annex II); must provide synergy with, complement and be consistent with other EU internal and external policies and funding; operates within the EU\u2019s overall enlargement policy framework. The budget for the 7-year programme is \u20ac14.162 billion. The funds may be used for: preparation; monitoring; control; audit; evaluation; and corporate information technology systems. Finance to beneficiaries is based on: an IPA programming framework, which contains the annual expenditure that the European Parliament and Council of the European Union authorise and takes account of national strategies and sectoral policies; performance (Annex IV contains a list of key indicators) and fair share principles, and is targeted and adjusted to specific situations. Cross-border cooperation projects benefit from up to 3% of the total budget with a maximum EU contribution of 85%. EU Member States, IPA III beneficiaries, countries in the European Economic Area and the Neighbourhood Area (Annex I of Regulation (EU) 2021/947 \u2014 see summary) are all eligible for funding. IPA III beneficiaries may obtain finance from the European Fund for Sustainable Development Plus and the External Action Guarantee (under Regulation (EU) 2021/947). Recipients of IPA III support must acknowledge the origin, and ensure the visibility, of the funding. The European Commission: may adopt implementing and delegated acts; is assisted by a committee for the IPA and advised by a strategic board for the western Balkans. Supplementing act Regulation (EU) 2021/1529 was supplemented by Commission Delegated Regulation (EU) 2021/2128 of 1 October 2021. Implementing acts Commission Implementing Regulation (EU) 2021/2236 lays down specific rules to ensure uniform implementation of IPA III assistance for IPA III beneficiaries. It also sets specific rules for cross-border cooperation and for agriculture and rural development assistance. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND IPA III ensures continuity with IPA II, which ran from 2014 to 2020. It complements the almost \u20ac80 billion Neighbourhood, Development and International Cooperation Instrument established under Regulation (EU) 2021/947. For further information, see: Overview \u2014 Instrument for Pre-accession Assistance (European Commission). MAIN DOCUMENT Regulation (EU) 2021/1529 of the European Parliament and of the Council of 15 September 2021 establishing the Instrument for Pre-Accession Assistance (IPA III) (OJ L 330, 20.9.2021, pp. 1\u201326). RELATED DOCUMENTS Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument \u2014 Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009 (OJ L 209, 14.6.2021, pp. 1\u201378). Successive amendments to Regulation (EU) 2021/947 have been incorporated into the original text. This consolidated version is of documentary value only. Commission Delegated Regulation (EU) 2021/2128 of 1 October 2021 supplementing Regulation (EU) 2021/1529 of the European Parliament and of the Council, as regards setting out certain specific objectives and thematic priorities for assistance under the Instrument for Pre-Accession Assistance (IPA III) (OJ L 432, 3.12.2021, pp. 8\u201312). Commission Implementing Regulation (EU) 2021/2236 of 15 December 2021 on the specific rules for implementing Regulation (EU) 2021/1529 of the European Parliament and of the Council establishing an Instrument for Pre-accession Assistance (IPA III) (OJ L 450, 16.12.2021, pp. 10\u201320). * This designation is without prejudice to positions on status, and is in line with UNSCR 1244/99 and the ICJ Opinion on the Kosovo declaration of independence. last update 01.12.2021"}
{"article": "14.6.2021 EN Official Journal of the European Union L 209/1 REGULATION (EU) 2021/947 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe, amending and repealing Decision No 466/2014/EU and repealing Regulation (EU) 2017/1601 and Council Regulation (EC, Euratom) No 480/2009 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 209 and 212 and Article 322(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Having regard to the opinion of the Court of Auditors (3), Acting in accordance with the ordinary legislative procedure (4), Whereas: (1) The general objective of the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe (the \u2018Instrument\u2019), which is a programme for the purpose of the multiannual financial framework, should be to uphold and promote the Union\u2019s values, principles and fundamental interests worldwide in order to pursue the objectives and principles of the Union\u2019s external action, as laid down in Article 3(5) and Articles 8 and 21 of the Treaty on European Union (TEU). (2) In accordance with Article 21 TEU, the Union is to ensure consistency between the different areas of its external action and between these and its other policies, as well as to work for a high degree of cooperation in all fields of international relations. The wide array of actions supported under the Instrument should contribute to the objectives set out in Article 21(1) and (2) TEU. (3) Union action should promote respect for and be rooted in international human rights law, including the Universal Declaration of Human Rights, and in international humanitarian law, and should be guided by the universality and indivisibility of human rights. (4) In accordance with Article 8(1) TEU, the Union is to develop a special relationship with neighbouring countries, aiming to establish an area of prosperity and good neighbourliness, founded on the values of the Union and characterised by close and peaceful relations based on cooperation. The Instrument should contribute to that objective. (5) The primary objective of the Union\u2019s development cooperation policy, as laid down in Article 208 of the Treaty on the Functioning of the European Union (TFEU), is the reduction and, in the long term, the eradication of poverty. The Union\u2019s development cooperation policy also contributes to the objectives of the Union\u2019s external action, in particular to foster the sustainable economic, social and environmental development of developing countries, with the primary aim of eradicating poverty, as set out in point (d) of Article 21(2) TEU. (6) The Union is to ensure policy coherence for development cooperation as required by Article 208 TFEU. The Union should take account of the objectives of development cooperation in the policies that are likely to affect developing countries, which will be a crucial element of the strategy to achieve the Sustainable Development Goals (SDGs) defined in the 2030 Agenda for Sustainable Development ('2030 Agenda') adopted by the United Nations (UN) in September 2015. Ensuring policy coherence for sustainable development, as embedded in the 2030 Agenda, requires taking into account the impact of all policies on sustainable development at all levels nationally, within the Union, in other countries and at global level. (7) The Instrument should contribute to preserving peace, preventing conflicts and strengthening international security as set out in point (c) of Article 21(2) TEU. (8) The Instrument should be established for a period of seven years to align its duration with that of the multiannual financial framework 2021-2027 laid down in Council Regulation (EU, Euratom) 2020/2093 (5) (the \u20182021-2027 MFF\u2019). (9) The Instrument should provide for actions in support of those Union objectives and of the Union\u2019s external action policies and builds on the actions previously supported under Regulations (EU) No 230/2014 (6), (EU) No 232/2014 (7), (EU) No 233/2014 (8), (EU) No 234/2014 (9), (EU) No 235/2014 (10), (EU) No 236/2014 (11) and (EU) 2017/1601 (12) of the European Parliament and of the Council, Decision No 466/2014/EU of the European Parliament and of the Council (13), Council Regulations (EC, Euratom) No 480/2009 (14), (Euratom) No 237/2014 (15) and (EU) 2015/322 (16), and the 11th European Development Fund (EDF)\u2019s Internal Agreement (17). (10) The global context for action is the pursuit of a rules-based and values-based global order, with multilateralism as its key principle and the UN at its core. The 2030 Agenda, together with the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (18) (the \u2018Paris Agreement\u2019) and the Addis Ababa Action Agenda of the Third International Conference on Financing for Development (the \u2018Addis Ababa Action Agenda\u2019) is the international community\u2019s response to global challenges and trends in relation to sustainable development. With the SDGs at its core, the 2030 Agenda is a transformative framework to eradicate poverty and achieve sustainable development globally. It is universal in scope, providing a comprehensive shared framework for action that applies to the Union, its Member States and its partners. It balances the economic, social and environmental dimensions of sustainable development, recognising the essential interlinkages between its goals and targets. The 2030 Agenda aims to leave no one behind and seeks to reach the furthest behind first. The implementation of the 2030 Agenda would be closely coordinated with the Union\u2019s other relevant international commitments. Actions supported under the Instrument should be guided by the principles and objectives set out in the 2030 Agenda, the Paris Agreement and the Addis Ababa Action Agenda and should contribute to achieving the SDGs. Particular attention should be paid to interlinkages between the SDGs and to integrated actions that can create co-benefits and meet multiple objectives in a coherent way without undermining other objectives. (11) The implementation of the Instrument should be guided by the five priorities established in the Global Strategy for the European Union\u2019s Foreign and Security Policy (June 2016) (the \u2018Global Strategy\u2019) endorsed by the Council in its conclusions of 17 October 2016, which represents the Union\u2019s vision and framework for united and responsible external engagement in partnership with others, to advance its values and interests. The Union should enhance partnerships, promote policy dialogue and collective responses to challenges of global concern. Its action should support the Union\u2019s fundamental interests, principles and values in all their aspects. In doing so, the Union should use an integrated approach and comply with, and promote, the principles of respect for high social, labour and environmental standards, including with regard to climate change, for the rule of law and for international law, including in respect of humanitarian and international human rights law. (12) The implementation of the Instrument should also be guided by the European Consensus on Development of 8 June 2017 (the \u2018Consensus\u2019) which provides the framework for a common approach to development cooperation by the Union and its Member States to implement the 2030 Agenda and the Addis Ababa Action Agenda. Eradicating poverty, tackling discrimination and inequalities, leaving no one behind, protecting the environment and fighting climate change, and strengthening resilience are at the heart of development cooperation policy and should underpin the implementation of the Instrument. (13) The Instrument should take into account relevant policy documents, including future revisions thereof, such as: the UN Convention relating to the Status of Refugees, the UN Convention on the Elimination of All Forms of Discrimination against Women, the UN Convention on the Rights of the Child, the Programme of Action of the International Conference on Population and Development (ICPD), the Beijing Platform for Action, the UN Convention on the Rights of Persons with Disabilities, the EU Concept for Support to Disarmament, Demobilisation and Reintegration, the Comprehensive approach to the EU implementation of the United Nations Security Council Resolutions (UNSCRs) 1325 (2000) and 1820 (2009) on women, peace and security, the Concept on Strengthening EU Mediation and Dialogue Capacities, the Council conclusions of 20 June 2011 on conflict prevention, the EU Strategic Framework on Human Rights and Democracy and the Action Plans based thereon, the Council conclusions of 14 November 2016 on EU-wide strategic framework to support Security Sector Reform endorsing the Joint Communication on \u2018Elements for an EU-wide strategic framework to support Security Sector Reform\u2019, the EU strategy against illicit firearms, small arms and light weapons and their ammunition, the EU Human Rights guidelines, other relevant UN conventions and the International Atomic Energy Agency Convention on Nuclear Safety. (14) The Instrument should aim to increase the coherence and ensure the effectiveness of the Union\u2019s external action thus improving the implementation of the different external action policies. (15) In accordance with the Global Strategy, the Consensus and the Sendai Framework adopted on 18 March 2015 for Disaster Risk Reduction 2015-2030, recognition should be given to the need to move away from crisis response and containment to a more structural, long-term approach that more effectively addresses situations of fragility, natural and man-made disasters, and protracted crises. Greater emphasis and collective approaches are required on risk reduction, prevention, mitigation and preparedness, and further efforts are required to enhance swift response and a durable recovery. The Instrument should therefore contribute to strengthening resilience and linking humanitarian aid and development action, particularly through rapid response actions as well as relevant geographic and thematic programmes, while ensuring respect of humanitarian principles. (16) In accordance with the international commitments of the Union in relation to the Busan Partnership Agreement for Effective Development Cooperation, reaffirmed at the Nairobi High Level Forum in 2016 and recalled in the Consensus, the Union should apply, in the context of its Official Development Assistance (ODA) and across all aid modalities, the development effectiveness principles, namely ownership of development priorities by developing countries, a focus on results, inclusive development partnerships, transparency and mutual accountability as well as alignment and harmonisation. In that regard, it is important that national development strategies include broad consultative processes in line with the principles of the Paris Declaration on Aid Effectiveness, in particular when those serve as a basis for programming. (17) Pursuant to the SDGs, the Instrument should contribute to reinforced monitoring and reporting with a focus on results, covering outputs, outcomes and impacts in partner countries benefiting from the Union\u2019s external financial assistance. (18) The Commission should ensure that clear monitoring and evaluation mechanisms are in place in order to provide effective accountability and transparency in implementing the Union budget, and in order to ensure effective assessment of progress towards the achievement of the objectives of the Instrument. Whenever possible and appropriate, the results of the Union\u2019s external action should be monitored and evaluated on the basis of pre-defined, transparent, country-specific and measurable indicators, adapted to the specificities and objectives of the Instrument and preferably based on the results framework of the partner country. (19) The Commission should regularly monitor actions financed under the Instrument and review progress made towards expected results, covering outputs and outcomes. Wherever possible, existing results frameworks should be used. The indicators used to measure progress should be in line with the SDGs and be clear, relevant and have robust methodologies. The data for the indicators should be readily available and of a good quality. The values of the indicators on 1 January 2021 should be used as a basis for assessing the extent to which the objectives of the Instrument have been achieved and will feed into the annual reports as well as the mid-term and final evaluations of the Instrument. The Commission should also make appropriate use of independent external evaluations. In that regard, the Commission should ensure, where relevant, appropriate involvement of the European Parliament, the Council as well as other stakeholders, including civil society organisations. (20) The Commission should send its evaluation reports to the European Parliament, to the Council and to the Member States. Evaluations may be discussed at the request of Member States pursuant to this Regulation. (21) The Instrument should contribute to the collective Union objective of providing 0,7 % of Gross National Income (GNI) as ODA within the timeframe of the 2030 Agenda, by supporting realistic, verifiable actions to meet this commitment, on which progress should continue to be monitored and reported. In that regard, at least 93 % of the funding under the Instrument should contribute to actions designed in such a way that they fulfil the criteria for ODA as established by the Development Assistance Committee of the Organisation for Economic Cooperation and Development (OECD). (22) In order to ensure resources are provided to where the need is greatest, especially to the Least Developed Countries (LDCs) and the countries in situations of fragility and conflict, the Instrument should contribute to the Union collective target of reaching between 0,15 and 0,20 % of the Union GNI as ODA to LDCs in the short term, and of reaching 0,20 % of GNI as ODA within the timeframe of the 2030 Agenda, by supporting realistic, verifiable actions to meet this commitment, on which progress should continue to be monitored and reported. As agreed in the Consensus, actions under the Instrument are expected to contribute at least 20 % of the ODA funded under the Instrument to social inclusion and human development, including basic social services, such as health, education, nutrition, water, sanitation and hygiene, and social protection, particularly to the most marginalised. (23) The Instrument should support children and youth as key agents of change and as contributors to the realisation of Agenda 2030, giving particular attention to their needs and empowerment. (24) The Instrument should reflect the need to focus on strategic priorities, both geographically \u2013 the European Neighbourhood and Africa, as well as countries that are in a situation of fragility and most in need \u2013 but also thematically \u2013 security, migration, climate change and environment, and human rights and democracy. (25) The Instrument should contribute to creating state and societal resilience in the area of global public health by addressing global public health threats, strengthening health systems, achieving universal health coverage, preventing and combating communicable diseases and helping to secure affordable medicines and vaccines for all. (26) The financial envelopes envisaged for the Neighbourhood and Sub-Saharan Africa geographic programmes should only be increased, given the particular priority the Union gives to those regions. (27) The Instrument should support the implementation of the European Neighbourhood Policy, as reviewed in 2015 and endorsed by the Council in its conclusions of 14 December 2015, while maintaining an adequate geographical balance, and the implementation of regional cooperation frameworks, such as cross-border cooperation, transnational and maritime cooperation as well as the external aspects of relevant macro-regional and sea basin strategies and policies in the eastern and southern neighbourhood, including the Northern Dimension and the Black Sea regional cooperation, as well as the integrated Union policy for the Arctic. Those initiatives offer political supplementary frameworks for deepening relations with and among partner countries, based on the principles of mutual accountability, shared ownership and responsibility. (28) The European Neighbourhood Policy aims to deepen democracy, promotion of human rights and upholding of the rule of law, the stabilisation of neighbouring countries and strengthening their resilience, particularly by promoting political, economic and social reforms, as the Union\u2019s main political priorities. In order to attain its objective, the European Neighbourhood Policy, which was reviewed in 2015, focuses on the following priority areas: good governance, democracy, the rule of law and human rights, with a particular focus on engaging further with civil society; socio-economic development, including the fight against youth unemployment, as well as education and environmental sustainability and enhanced connectivity; security; and migration and mobility, including tackling the root causes of irregular migration and forced displacement. Differentiation and enhanced mutual ownership, including through the implementation of the incentive-based approach that responds to performance in key areas, are the hallmark of the European Neighbourhood Policy, recognising different levels of engagement, and reflecting the interests of each country concerning the nature and focus of its partnership with the Union. The Instrument should support the implementation of the association, partnership and cooperation agreements, jointly agreed association agendas and partnership priorities, and other relevant, existing and future, jointly agreed documents with countries in the Neighbourhood area. The visibility of Union assistance in the Neighbourhood area should be enhanced. (29) The Instrument should support the implementation of the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States, of the one part, and the European Community and its Member States, of the other part (19) ('the ACP-EU Partnership Agreement'), signed in Cotonou on 23 June 2000 and entered into force on 1 April 2003, and subsequent agreements with countries of the Africa, Caribbean and Pacific (ACP) Group of States and allow the Union and its ACP partners to develop further strong alliances on key global challenges. In particular, the Instrument should support the continuation of the established cooperation between the Union and the African Union in line with the Joint Africa-EU Strategy and build on the ACP-EU Partnership Agreement, including by way of a continental approach towards Africa and a mutually beneficial partnership of equals between the Union and Africa. (30) The Union should also seek to further develop relations and build partnerships with third countries in Asia and the Americas. Geographic programmes should support the Pacific and the Caribbean with an indicative amount of at least EUR 500 000 000 and at least EUR 800 000 000, respectively. (31) The Instrument should also contribute to the trade-related aspects of the Union\u2019s external relations including supply-chain due diligence in order to ensure consistency and mutual support between Union trade policy and development goals and actions. (32) The Union should seek the most efficient use of available resources in order to optimise the impact of its external action. That should be achieved through coherence, consistency and complementarity among the Union\u2019s external financing instruments, in particular the Instrument for Pre-Accession Assistance established by a Regulation of the European Parliament and of the Council establishing the Instrument for Pre-accession Assistance (IPA III) (the \u2018IPA III Regulation\u2019), the Humanitarian Aid Instrument established by Council Regulation (EC) No 1257/96 (20), the association of the overseas countries and territories with the Union established by a Council Decision on the Association of the Overseas Countries and Territories with the European Union including relations between the European Union on the one hand, and Greenland and the Kingdom of Denmark on the other ('the Decision on the Overseas Association, including Greenland'), the European Instrument for International Nuclear Safety Cooperation established by Council Regulation (Euratom) 2021/948 (21), the common foreign and security policy including, where relevant, the Common Security and Defence Policy, and the European Peace Facility established by Council Decision (CFSP) 2021/509 (22) which is financed outside the Union budget, as well as the creation of synergies with other Union policies and programmes. This includes coherence and complementarity with macro-financial assistance, where relevant. In order to maximise the impact of combined interventions to achieve a common objective, the Instrument should allow for the combination of funding with other Union programmes, as long as the contributions do not cover the same costs. (33) Building on its success, the Instrument should enable the Union to further strengthen the external dimension of the Erasmus+ programme. An indicative amount of EUR 1 800 000 000 from the geographic programmes under the Instrument should be used to finance actions under the international dimension of the Erasmus+ programme implemented in accordance with Regulation (EU) 2021/817 of the European Parliament and of the Council (23) and with the programming document adopted under the Instrument. Programming under the Instrument should fully enhance the potential of the Erasmus+ programme. (34) Union funding under the Instrument should be used to finance actions under the international dimension of the Creative Europe programme established by Regulation (EU) 2021/818 of the European Parliament and of the Council (24) in order to contribute to foster international cultural relations and recognise the role of culture in promoting European values. (35) The main approach for actions financed under the Instrument should be through geographic programmes, in order to maximise the impact of the Union\u2019s assistance and bring Union\u2019s action closer to partner countries and populations. That main approach should be complemented, where relevant, by thematic programmes and by rapid response actions, whilst ensuring the consistency and coherence of all programmes and actions. (36) Local authorities embrace a large variety of sub-national levels and branches of government, including municipalities, communities, districts, counties, provinces, regions and their associations. In line with the Consensus, the Union should foster close consultation and association of local authorities, as well as their participation in contributing to sustainable development and to the implementation of the SDGs at local level, in particular regarding democracy, the rule of law, human rights and fundamental freedoms, social justice and as providers of basic social services. The Union should recognise the multiple roles played by local authorities as promoters of a territorial approach to local development, including decentralisation processes, participation and accountability. The Union should further enhance its support for local authorities\u2019 capacity building in order to strengthen their voice in the sustainable development process and advance political, social and economic dialogue, as well as promote decentralised cooperation. Support to local authorities under the geographic programmes should amount indicatively to at least EUR 500 000 000. (37) The Union\u2019s and Member States\u2019 development cooperation policies should complement and reinforce each other. The Union and its Member States should be united in diversity and working better together, using a variety of experiences and approaches, bearing in mind their respective comparative advantages. Therefore, the Union should foster inclusiveness and collaboration with Member States seeking to maximise added value and taking into account experience and capacities, thus reinforcing shared interests, values and common goals. In that regard, the Union and its Member States should also seek to promote the exchange of best practices, knowledge sharing and capacity building amongst them. In cases of forms of Union funding in which public administrations of Member States are involved, such as twinning, simplified implementing and contractual provisions should be discussed with Member States and applied in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (25) (the \u2018Financial Regulation\u2019). (38) In line with the Consensus, the Union and its Member States should enhance joint programming to increase their collective impact by bringing together their resources and capacities. Joint programming should be promoted and strengthened, while being kept voluntary, flexible, inclusive and tailored to the country context and should allow for the replacement of Union and Member States\u2019 programming documents with Union joint programming documents. Joint programming should build on the partner countries\u2019 engagement, appropriation and ownership. The Union and its Member States should seek to support partner countries through joint implementation, whenever appropriate. Joint implementation should be inclusive and open to all Union partners who agree and can contribute to a common vision, including Member States\u2019 agencies and their development financial institutions, local authorities, the private sector, civil society and academia. (39) The criteria used to establish partners\u2019 needs in the programming approach should be consistent with the transparency principles laid down in this Regulation. (40) As the respect for democracy, human rights and the rule of law is essential for sound financial management and effective Union funding as referred to in the Financial Regulation, assistance could be suspended in the event of degradation in democracy, human rights or the rule of law in third countries. (41) The Union is committed to facilitating the objectives of nuclear safety cooperation specified in Regulation (Euratom) 2021/948. Therefore, the partner countries\u2019 track records in implementing obligations and commitments concerning nuclear safety should be taken into account and be taken up in the regular political dialogue with those countries. Where a partner country persistently fails to respect the basic nuclear safety standards and provisions of the relevant international conventions, the Union should take appropriate steps. (42) Under the Instrument, the Union should address human rights and democratisation issues at all levels. Whilst democracy and human rights, including gender equality and women\u2019s empowerment should be reflected and mainstreamed throughout the implementation of the Instrument, Union assistance under the Human Rights and Democracy thematic programme and the Civil Society Organisations thematic programme should have a specific complementary and additional role by virtue of its global nature and its independence of action from the consent of the governments and public authorities of the third countries concerned. That role should allow for cooperation and partnership with civil society, especially on sensitive human rights and democracy issues. The Union should pay particular attention, in a flexible manner, to countries and urgency situations where human rights and fundamental freedoms are most at risk and where disrespect for those rights and freedoms is particularly pronounced and systematic. (43) EU election observation missions should contribute to increase transparency and confidence in electoral processes, and provide an informed assessment of elections as well as recommendations for their further improvement, in the context of Union cooperation and political dialogue with partner countries. An indicative amount not exceeding 25 % of the resources initially allocated to the Human Rights and Democracy thematic programme should be devoted to the funding of EU election observation missions. (44) The implementation of the Instrument should be guided by the principles of gender equality, women and girls\u2019 empowerment and of preventing and combating violence against women and domestic violence, and should seek to protect and promote women\u2019s rights in line with the EU Gender Action Plans and relevant Council conclusions and international conventions, including the Council conclusions on Women Peace and Security of 10 December 2018. Strengthening gender equality and women\u2019s empowerment in the Union\u2019s external action and increasing efforts to reach the minimum standards of performance indicated by the EU Gender Action Plans should lead to a gender sensitive and transformative approach in all Union external action and international cooperation. At least 85 % of new actions implemented under the Instrument should have gender equality as a principal or a significant objective, as defined by the gender equality policy marker of the OECD Development Assistance Committee. At least 5 % of those actions should have gender equality and women\u2019s and girls\u2019 rights and empowerment as a principal objective. (45) The Instrument recognises that demographic growth and demographic shifts can have significant impact on development gains and economic progress. In order to ensure that current and future generations will be able to achieve their full potential in a sustainable way, the Instrument should support partners\u2019 efforts towards an integrated approach that minimises the challenges related to population growth and maximises the benefits of a demographic dividend, while respecting each country\u2019s right to decide on its demographic policy and while respecting, protecting and fulfilling human rights as well as gender equality. (46) Civil society organisations embrace a wide range of actors with multiple roles and mandates which includes all non-State, not-for-profit independent and non-violent structures, through which people organise the pursuit of shared objectives and ideals, whether political, cultural, religious, environmental, social or economic. Operating from local, national, regional and international levels, they comprise urban and rural, formal and informal organisations. The Union values civil society organisations\u2019 diversity and specificities, and engages with accountable and transparent civil society organisations which share its commitment to sustainable development and to the fundamental values of peace, freedom, equal rights and human dignity. The Instrument should provide Union support to civil society organisations in order to pursue the values, interests and objectives of the Union. Civil society organisations should be duly consulted and have timely access to relevant information allowing them to be adequately involved and play a meaningful role during the design, implementation and associated monitoring processes of programmes. The role of organisations supporting democracy, free elections, civil society, human rights and the rule of law worldwide, such as the European Endowment for Democracy, as well as citizen election observation organisations and their European and other regional and global platforms, should be supported under the Instrument. (47) The Instrument should foster the participation of civil society organisations in contributing to sustainable development and to the implementation of the SDGs, inter alia, in the areas of democracy, the rule of law, human rights and fundamental freedoms, social justice and basic social services. (48) This Regulation lays down a financial envelope for the Instrument, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (26), for the European Parliament and the Council during the annual budgetary procedure. (49) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement and to achieve the UN SDGs, the Instrument should contribute to mainstream climate action in the Union policies and to the achievement of an overall target of 30 % of the Union budget expenditure supporting climate objectives. Actions under the Instrument are expected to contribute 30 % of its overall financial envelope to climate objectives. Relevant actions will be identified during the implementation of the Instrument, and the overall contribution from the Instrument should be part of relevant monitoring, evaluations and review processes. In view of contributing to halting and reversing the decline of biodiversity, the Instrument should contribute to the ambition of providing 7,5 % of annual spending under the multiannual financial framework to biodiversity objectives in the year 2024 and 10 % of annual spending under the multiannual financial framework to biodiversity objectives in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. Union action in this area should favour the adherence to the Paris Agreement and the UN Convention on Biological Diversity, the UN Framework Convention on Climate Change and the UN Convention to Combat Desertification, and not contribute to environmental degradation or cause harm to the environment or climate. In particular, funding allocated in the context of the Instrument should be coherent with the long-term temperature goal of holding the increase in the global average temperature to well below 2\u00b0C above pre-industrial levels and pursuing efforts to limit the temperature increase to 1,5\u00b0C. It should also be coherent with the objective to increase the ability to adapt to the adverse effects of climate change and foster climate resilience. Particular attention should be given to actions that create co-benefits and meet multiple objectives, including for climate, biodiversity and the environment. (50) The Union should favour a constructive engagement on mobility and all aspects of migration, working to ensure that migration takes place in a safe and well-regulated manner. It is essential to further step up cooperation on migration with partner countries while respecting competences of Member States, reaping the benefits of orderly, safe, regular and responsible migration and effectively addressing irregular migration and forced displacement. Such cooperation should contribute to ensuring access to international protection, addressing the root causes of irregular migration and forced displacement, enhancing border management and pursuing efforts to prevent irregular migration and forced displacement, fighting against trafficking in human beings and migrant smuggling, and working on dignified and sustainable returns, readmission and reintegration where relevant, on the basis of mutual accountability and full respect of humanitarian and human rights obligations under international and Union law, and by engaging with diasporas and supporting legal migration pathways. Therefore, third countries\u2019 effective cooperation with the Union in this area should be an integral element of the Instrument. Increased coherence between migration and development cooperation and other external policies is important to ensure that the Union\u2019s external assistance supports partner countries to manage migration more effectively towards sustainable development. The Instrument should contribute to a coordinated, holistic and structured approach to migration, maximising synergies and applying the necessary leverage. (51) The Instrument should enable the Union, in cooperation with Member States, to comprehensively respond to challenges, needs and opportunities related to migration and forced displacement in a way that is coherent with and complementary to Union migration policy. To contribute to that end and without prejudice to unforeseen circumstances, indicatively 10 % of the financial envelope for the Instrument should be dedicated particularly to actions supporting management and governance of migration and forced displacement within the objectives of the Instrument. In addition, that target should also include actions to address the root causes of irregular migration and forced displacement when they directly target specific challenges related to migration and forced displacement. Migration-related actions under the Instrument, as needed through its geographic and thematic programmes and rapid response actions, should build on the experience learned during the implementation of the European Agenda on Migration and the multiannual financial framework 2014-2020, to build comprehensive partnerships. Union support should take into account the development benefits of regular migration. Migration-related actions under the Instrument should contribute to the effective implementation of EU agreements and dialogues on migration with third countries by encouraging cooperation relying on a flexible incitative approach and supported by a coordination mechanism under the Instrument. The coordination mechanism should enable ongoing and emerging migration challenges to be addressed under the Instrument, using all appropriate components through flexible funding, while respecting its financial envelopes and relying on their flexible implementation. Those actions should be implemented in full respect of international law, including international human rights and refugee law, and Union and national competences. The Commission should develop and use a robust and transparent tracking system to measure such expenditure and to report on it. (52) The Instrument should consider digital solutions and information and communication technologies as powerful enablers for sustainable development and inclusive growth, and should contribute to further promoting digitalisation. (53) Actions adopted under the Instrument in relation to the fight against terrorism and organised crime, cyber security and the fight against cybercrime, and capacity building of military actors in support of development and security for development should aim to generate direct human security benefits for the population, contain relevant good practices to ensure sustainability and accountability in the medium and long term, including effective democratic oversight, and should promote the rule of law, transparency and established international law principles. (54) The 2030 Agenda underlines the importance of promoting peaceful and inclusive societies both as a SDG 16 and in order to achieve other development policy outcomes. SDG 16.a specifically requests to \u2018Strengthen relevant national institutions, including through international cooperation, for building capacities at all levels, in particular in developing countries, to prevent violence and combat terrorism and crime\u2019. (55) In the High Level Meeting Communiqu\u00e9 of 19 February 2016, the OECD Development Assistance Committee updated the reporting directives on ODA in the field of peace and security. The financing of the actions under the Instrument constitutes ODA when it fulfils the criteria set out in those reporting directives or any subsequent reporting directives, upon which the Development Assistance Committee is able to agree. (56) Capacity building in support of development and security for development should be used in exceptional cases only, where the objectives of the Instrument cannot be met by recourse to non-military actors. (57) The Instrument should build on the experience gained and lessons learned from actions on capacity-building for development and security for development, in particular from relevant consultations and evaluations, conducted within the framework of Regulation (EU) 2017/2306 of the European Parliament and of the Council (27). In that context, the Commission should also take into account, where appropriate, joint evaluations with Member States. (58) The Union should also promote a conflict-sensitive and gender-sensitive approach in all actions and programmes under the Instrument. (59) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (60) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden and the expected risk of non-compliance. When making that choice, the use of lump sums, unit costs and flat rates, as well as financing not linked to costs of the relevant operation as referred to in point (a) of Article 125(1) of the Financial Regulation, should be considered. (61) In accordance with Article 193(2) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to Union interests, it should be possible to provide in the financing decision, during a limited period of time at the beginning of the 2021-2027 MFF, and only in duly justified cases, for eligibility of actions and costs from 1 January 2021, even if those actions were implemented and those costs were incurred before the grant application was submitted. (62) The new European Fund for Sustainable Development Plus (EFSD+), built on the European Fund for Sustainable Development (EFSD) as established by Regulation (EU) 2017/1601, should constitute an integrated financial package supplying financing capacity in the form of grants, technical assistance, financial instruments, budgetary guarantees and blending operations worldwide. The EFSD+, complemented by efforts to improve the investment climate of partners, should become part of the External Investment Plan and combine blending and budgetary guarantee operations covered by the External Action Guarantee, including those covering sovereign risks associated with lending operations, previously carried out under the external lending mandate to the European Investment Bank (EIB). The allocation of funds to be used for EFSD+ operations should be based on the relevant programming documents, in particular the priorities defined therein, and should take into consideration, inter alia, the specific realities and needs of each partner country or region and the relative weight of the allocation of funds per geographical area laid down in this Regulation. Programming should lead to an appropriate balance between blending and budgetary guarantee operations under the EFSD+ as well as other forms of Union funding provided for in this Regulation. The EFSD+ should be implemented through an open and collaborative investment architecture to ensure the optimal use of the sectoral and geographic expertise of eligible counterparts and maximise its development impact. The EFSD+ should be composed of regional investment platforms within the regional areas covered by this Regulation and, where relevant, by the IPA III Regulation. To ensure that risk management of the EFSD+ is independent, impartial, inclusive and transparent, a technical risk assessment group, open to experts from the EIB, other eligible counterparts and interested Member States, organised and led by the Commission should be established. The Commission should ensure that information and analysis are shared in a timely, transparent and inclusive manner with all Member States, with due regard to confidentiality issues. The Commission should conclude External Action Guarantee agreements with all selected eligible counterparts, including the EIB, after consulting and taking into account the advice of the technical risk assessment group and should present the key elements of those agreements to the strategic board concerned. (63) Given its role under the Treaties and its experience over the last decades in supporting Union policies, the EIB should remain a natural partner of the Commission for the implementation of operations under the External Action Guarantee. The EIB and the Commission should enhance their cooperation and coordination throughout the implementation of the External Action Guarantee under the EFSD+, including during the programming process and in the field. The EIB should be entrusted with the implementation of a dedicated investment window covering comprehensive risk cover for operations with sovereign counterparts and non-commercial sub-sovereign counterparts, which should be exclusive except for operations that the EIB cannot carry out or decides not to carry out. Additional non-exclusive dedicated investment windows should be established for the EIB, if appropriate, to provide comprehensive risk cover for operations with commercial sub-sovereign counterparts, and operations for the promotion of foreign direct investment, trade and the internationalisation of partner countries\u2019 economies, including through inward foreign direct investments, as well as other Union thematic priorities in support of the objectives of the Instrument and in line with the SDGs, including with, but not limited to, European Development Finance Institutions and Union private sector entities. The EU guarantee should only provide a political risk cover for private sector operations, which should be coherent with those of the export credit agencies of Member States. Those investment windows, which should constitute the dedicated mandates required by the EIB to operate outside the Union, should apply the same rules and conditions as any other investment window under the EFSD+, including the rules of governance, and, except for the exclusive investment window, should be established in accordance with the procedure for eligibility and selection of operations and counterparts for the External Action Guarantee under the EFSD+ provided by this Regulation. For those three EIB-dedicated investment windows, the overall indicative amount should be EUR 26 725 000 000. The amounts for each of the investment windows should be substantiated and confirmed as a result of the programming process at the beginning of the multiannual financial framework and during the reviews of programming. The objectives, priorities and amounts for each of the investment windows and their implementation should ensure full policy alignment with the Union priorities and comply with this Regulation and the relevant multiannual indicative programmes, including its geographic and thematic priorities. The risk assessment and remuneration methodology under the EFSD+ should be consistently applied to all investment windows, including those dedicated to the EIB, in order to ensure a level playing field. The investment windows implemented by the EIB should be able to cover any of the countries eligible for the External Action Guarantee, in particular where most needed and in accordance with the geographical priorities of the Instrument and, where relevant, the IPA III Regulation. EFSD+ guarantees for EIB operations with commercial sub-sovereign counterparts and private sector operations should be undertaken on terms similar to guarantees provided to other eligible counterparts. It should be possible for EFSD+ guarantees for operations with sovereign counterparts and non-commercial sub-sovereign counterparts and operations with commercial sub-sovereign counterparts that do not generate substantial revenues, undertaken by the EIB or other eligible counterparts, to be non-remunerated to help reduce the cost of financing for public sector investments undertaken by partner countries. In compliance with the objectives and general principles of the Instrument, the relevant indicative programming documents as well as, where relevant, the IPA III Regulation, the Commission and the EIB should conclude dedicated External Action Guarantee agreements for the EIB dedicated investment windows. (64) The EFSD+ should aim to support investments as a means of contributing to the achievement of the SDGs by fostering sustainable and inclusive economic, environmental and social development, transition into sustainable value-added economy and a stable investment environment, and promoting socio-economic and environmental resilience in partner countries with a particular focus on the eradication of poverty, contributing to the reduction of socio-economic inequalities, sustainable and inclusive growth, the fight against climate change in line with the Paris Agreement, climate change adaptation and mitigation, environmental protection and management, the creation of decent jobs on the basis of the core labour standards of the International Labour Organization (ILO), economic opportunities, skills and entrepreneurship, socio-economic sectors, including social enterprises and cooperatives, micro, small and medium-sized enterprises (\u2018SMEs\u2019), sustainable connectivity and, support to vulnerable groups, respect of human rights, gender equality and the empowerment of women and young people, as well as addressing specific socio-economic root causes of irregular migration and root causes of forced displacement, in accordance with the relevant indicative programming documents. The implementation of the EFSD+ should comply with the objectives, general principles and policy framework of the Instrument and, where relevant, the IPA III Regulation, in particular the applicable internationally agreed guidelines, principles and conventions on investment, including the UN Principles for Responsible Investment, the UN Guiding Principles on Business and Human Rights, the OECD Guidelines for Multinational Enterprises, the UN Food and Agriculture Organization\u2019s Principles for Responsible Investment in Agriculture and Food Systems, ILO conventions, international human rights law and the development effectiveness principles as set out in the Busan Partnership for Effective Development Cooperation and reaffirmed at the Nairobi High Level Forum in 2016, including ownership, alignment, focus on results, transparency and mutual accountability, as well as the objective of untying aid. Special attention should be given to countries identified as experiencing fragility or conflict, LDCs, small island developing states, landlocked developing countries and heavily indebted poor countries. (65) The EFSD+ should maximise additionality of funding, address market failures and sub-optimal investment situations, support local public entities in scaling up and autonomously financing their investment, deliver innovative products and \u2018crowd-in\u2019 private sector funds. Additionality should be applied in accordance with the objectives and principles of the Instrument and with other relevant Union policies. Involvement of the private sector, including SMEs, in the Union\u2019s cooperation with partner countries through the EFSD+ should yield a measurable and additional development impact without distorting the local market and unfairly competing with local economic actors. It should be cost-effective, transparent, based on mutual accountability and risk and cost sharing. The EFSD+ should operate as a \u2018one-stop-shop\u2019, receiving financing proposals from financial institutions and public or private investors and delivering a wide range of financial support to eligible investments. The leveraging effect of EFSD+ should be evaluated, measuring the mobilisation of additional funding for sustainable development through the use of the EFSD+ financial support. The leverage effect should be measured according to the definition laid down in point 38 of Article 2 of the Financial Regulation and international rules and practices for measuring the amounts mobilised from the private sector by official development finance interventions, such as the OECD Development Assistance Committee methodologies. The European Parliament and the Council should be able to invite eligible counterparts and civil society to an exchange of views concerning the financing and investment operations covered by this Regulation. (66) An External Action Guarantee should be established, building on the existing EFSD Guarantee established by Regulation (EU) 2017/1601 and the guarantees supported by the Guarantee Fund for external action established by Regulation (EC, Euratom) No 480/2009 The External Action Guarantee should support the EFSD+ operations covered by budgetary guarantees, macro-financial assistance and loans to third countries based on Council Decision 77/270/Euratom (28). Those operations should be supported by appropriations under the Instrument, together with those under the IPA III Regulation and Regulation (Euratom) 2021/948, which should also cover the provisioning and liabilities arising from macro-financial assistance loans and loans to third countries referred to in Article 10(2) of Regulation (Euratom) 2021/948, respectively. When funding EFSD+ operations, priority should be given to those which maximise additionality and development impact, including those which have a high impact on decent job creation and whose cost-benefit ratio enhances the sustainability of investment and which provide for sustainability and long-term development impact. The operations supported with the External Action Guarantee should be accompanied by an in-depth ex ante assessment of environmental, financial and social aspects, as appropriate and in line with the Better Regulation requirements. Budgetary guarantees and financial instruments should adhere to the Union policy on non-cooperative jurisdictions for tax purposes and updates thereto, as laid down in relevant legal acts of the Union and Council conclusions, in particular the Council conclusions of 8 November 2016 and the Annex thereto as well as principles laid down in Directive (EU) 2015/849 of the European Parliament and of the Council (29). All relevant Financial Regulation provisions apply, in particular those on indirect management laid down in Title VI of the Financial Regulation. The provision of essential public services should remain a government responsibility. (67) In order to provide for flexibility, increase the attractiveness for the private sector and maximise the impact of the investments, a derogation from the rules related to the methods of implementation of the Union budget, as laid down in the Financial Regulation, should be provided as regards the eligible counterparts. Those eligible counterparts could also be bodies which are not entrusted with the implementation of a public-private partnership or bodies governed by the private law of a partner country. (68) In order to increase the impact of the External Action Guarantee, Member States and contracting parties to the Agreement on the European Economic Area (30) should have the possibility of providing contributions in the form of cash or a guarantee. A contribution in the form of a guarantee should not exceed 50 % of the amount of operations guaranteed by the Union. The financial liabilities arising from that guarantee should not be provisioned and the liquidity cushion should be provided by the common provisioning fund established by Article 212 of the Financial Regulation. (69) External actions are often implemented in a highly volatile environment requiring continuous and rapid adaptation to the evolving needs of Union partners, to global challenges to human rights, democracy and good governance, security and stability, climate change and the environment, and oceans, and to challenges related to migration and forced displacement and their root causes. Reconciling the principle of predictability with the need to react rapidly to new needs consequently means adapting the financial implementation of the programmes. To increase the ability of the Union to respond to unforeseen needs, and building on the successful experience of the European Development Fund, an amount should be left unallocated as an emerging challenges and priorities cushion. It should be mobilised in accordance with the procedures established in this Regulation. (70) The emerging challenges and priorities cushion should guarantee the following additional resources: EUR 200 000 000 for the Human Rights and Democracy thematic programme, EUR 200 000 000 for the Civil Society Organisations thematic programme and EUR 600 000 000 for the Global Challenges thematic programme. (71) The Commission should inform in detail the European Parliament before it mobilises the funds of the emerging challenges and priorities cushion and should fully take into consideration its observations on the nature, objectives and financial amounts envisaged. (72) Therefore, while respecting the principle that the Union budget is set annually, this Regulation should preserve the possibility to apply the flexibilities already allowed by the Financial Regulation for other policies, namely carry-overs and re-commitments of funds, to ensure efficient use of the Union funds both for Union citizens and the partner countries, thus maximising the Union funds available for the Union\u2019s external action interventions. (73) Capacity building of military actors in third countries should be undertaken as part of the Union\u2019s development cooperation policy when it mainly pursues objectives in the field of development and as part of the Union\u2019s Common Foreign and Security Policy (CFSP) when it mainly pursues objectives in the field of peace and security, in compliance with Article 40 TEU. This Regulation respects the application of the procedures and the extent of the powers of the institutions under the Union\u2019s development cooperation policy and the Union\u2019s CFSP. (74) Actions under the Instrument that involve the provision or financing of equipment, services or technology should be in line with relevant Union, national and international provisions, in particular the rules set out in Council Common Position 2008/944/CFSP (31), with Union restrictive measures as well as with Regulation (EU) 2021/821 of the European Parliament and of the Council (32). Risk assessments by the Commission under the Instrument are without prejudice to the assessment of export licence applications by Member States. Each Member State should assess the export licence applications made to it, including those relating to government-to-government transfers, for items on the EU Common Military List, on a case-by-case basis against the criteria established in Common Position 2008/944/CFSP. In accordance with Regulation (EU) 2019/125 of the European Parliament and of the Council (33) such actions should not finance the provision of any type of equipment that may be used for torture or other cruel, inhuman or degrading treatment or punishment. (75) The Decision on the Overseas Association, including Greenland lays down the financial envelope for the association of the overseas countries and territories with the Union. That financial envelope is the main source of funding for overseas countries and territories. Pursuant to the Decision on the Overseas Association, including Greenland, persons and entities established in overseas countries and territories should be eligible for funding under that Decision, subject to its rules and objectives and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. Moreover, cooperation between the partner countries and the overseas countries and territories as well as the Union outermost regions under Article 349 TFEU should be encouraged in areas of common interest. (76) In order to enhance partner countries\u2019 ownership of their development processes and the sustainability of external aid, the Union should, where relevant, favour the use of partner countries\u2019 own institutions, capacities and expertise and of partner countries\u2019 systems and procedures for all aspects of the project cycle for cooperation while ensuring the full involvement of local governments and civil society. The Union should make available information and training on how to apply for Union funding to potential beneficiaries of Union funding. (77) Communication fosters democratic debate, reinforces institutional control and scrutiny over Union funding, and contributes to boosting the credibility of the Union. The Union and the beneficiaries of Union funding should enhance the visibility of the Union\u2019s action, and communicate adequately the added value of the Union\u2019s support. In that regard, in accordance with the Financial Regulation, agreements concluded with recipients of Union funding should contain obligations ensuring appropriate visibility and the Commission should act in an appropriate and timely manner where these obligations are not met. (78) Annual or multi-annual action plans and measures referred to in this Regulation should constitute work programmes under the Financial Regulation. Annual or multi-annual action plans should consist of a set of measures grouped into one document. (79) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (34) and Council Regulations (EC, Euratom) No 2988/95 (35), (Euratom, EC) No 2185/96 (36) and (EU) 2017/1939 (37), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (38). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. For that reason, agreements with third countries and territories and with international organisations, and any contract or agreement resulting from the implementation of the Instrument, should contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits, on-the-spot checks and inspections, in accordance with their respective competences and ensuring that any third parties involved in the implementation of Union funding grant equivalent rights. (80) The Instrument should contribute to the international fight against tax fraud, tax evasion, fraud, corruption and money laundering. (81) In order to supplement or amend non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the amount of actions for capacity building of military actors in support of development and security for development, the maximum amount for the External Action Guarantee, the provisioning rates and maximum provisioning amount for the External Action Guarantee, the areas of cooperation and intervention listed in Annexes II, III and IV, the priority areas of the EFSD+ operations listed in Annex V, the indicators in Annex VI, as well as in respect of supplementing this Regulation with specific objectives and priority areas of cooperation drawn from the areas of cooperation for the geographic programmes set out in Annex II, including a prioritisation per sub-region, thematic targets and indicative financial allocations for certain sub-regions, and of supplementing this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including with relevant stakeholders such as civil society and experts, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (39). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (82) In order to ensure uniform conditions for the implementation of the relevant provisions of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (40). (83) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Instrument should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators, as a basis for evaluating the effects of the Instrument on the ground. (84) The references to Union external assistance instruments in Article 9 of Council Decision 2010/427/EU (41), which are replaced by this Regulation, should be read as references to this Regulation. The Commission should ensure that this Regulation is implemented in accordance with the role of the European External Action Service as provided in that Decision. (85) Actions and measures as provided for in this Regulation should, where relevant, be complementary to, consistent with and respect the measures adopted by the Union in pursuit of the CFSP objectives within the framework of Chapter 2 of Title V TEU and the measures adopted within the framework of Title IV of Part Five TFEU. (86) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (87) Decision No 466/2014/EU should be amended and repealed, and Regulations (EU) 2017/1601 and (EC, Euratom) No 480/2009 should be repealed. (88) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the 2021-2027 MFF, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe (the \u2018Instrument\u2019), including the European Fund for Sustainable Development Plus (the \u2018EFSD+\u2019) and the External Action Guarantee, for the period of the 2021-2027 MFF. It lays down the objectives of the Instrument, the budget for the period from 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018country indicative programme\u2019 means an indicative programme covering one country; (2) \u2018multi-country indicative programme\u2019 means an indicative programme covering more than one country; (3) \u2018regional indicative programme\u2019 means a multi-country indicative programme covering more than one third country within the same geographic area as established in Article 4(2); (4) \u2018trans-regional indicative programme\u2019 means a multi-country indicative programme covering more than one third country from different geographic areas as established in Article 4(2); (5) \u2018cross-border cooperation\u2019 means cooperation between one or more Member States, and one or more third countries and territories along the external adjacent land and maritime borders of the Union and shall be understood to cover also transnational cooperation over larger transnational territories or around sea basins and interregional cooperation as laid down in a Regulation of the European Parliament and of the Council on specific provisions for the European territorial cooperation goal (Interreg) supported by the European Regional Development Fund and external financing instruments (the \u2018Interreg Regulation\u2019); (6) \u2018legal entity\u2019 means a natural person, or a legal person created and recognised as such under Union, national or international law, which has legal personality and the capacity to act in its own name, exercise rights and be subject to obligations, or an entity which does not have legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (7) \u2018civil society organisation\u2019 means a wide range of actors with multiple roles and mandates, which may vary over time and across institutions and countries, and includes all non-State, not-for-profit independent and non-violent structures, through which people organise the pursuit of shared objectives and ideals, including political, cultural, religious, environmental, social or economic, and which operate at local, national, regional or international levels, and which comprise urban and rural, formal and informal organisations; (8) \u2018local authority\u2019 encompasses public institutions with legal personality, which are components of the State structure, below the level of central government, such as villages, municipalities, districts, counties, provinces or regions, which are accountable to citizens and usually composed of a deliberative or policy-making body, such as a council or assembly, and an executive body, such as a mayor or other executive officer, which are directly or indirectly elected or selected at local level; (9) \u2018investment window\u2019 means a targeted area for support by the External Action Guarantee under the EFSD+ to portfolios of investments in specific regions, countries or sectors; (10) \u2018additionality\u2019 means the principle based on Article 209(2) of the Financial Regulation, according to which, in the context of this Regulation and the IPA III Regulation, the External Action Guarantee support under the EFSD+ contributes to sustainable development by operations which could not have been carried out without that Guarantee, or which achieve positive results above and beyond what could have been achieved without it. The principle of additionality also means that the operations supported by the External Action Guarantee crowd in private sector funding and address market failures or sub-optimal investment situations as well as improve the quality, sustainability, impact or scale of an investment. The principle also ensures that External Action Guarantee operations do not replace the support of a Member State, private funding or another Union or international financial intervention, and avoid crowding out other public or private investments unless duly justified in accordance with the objectives and principles of the Instrument. Projects supported by the External Action Guarantee typically have a higher risk profile than the portfolio of investments supported by the eligible counterparts under their normal investment policies without the External Action Guarantee; (11) \u2018operation with sovereign counterparts and non-commercial sub-sovereign counterparts\u2019 means any operation where the counterpart is either directly a State or a public entity fully backed by an explicit guarantee of the State because it does not have the legal capacity or the financial autonomy or ability to benefit from necessary direct financing; (12) \u2018operation with commercial sub-sovereign counterparts\u2019 means any operation where the counterpart is a public entity which is not backed by an explicit guarantee of a State and that is financially able to borrow at its own risk and has the legal capacity to do so; (13) \u2018contributor\u2019 means an international finance institution, a Member State or a public institution of a Member State, a public agency or other public or private entity contributing to the common provisioning fund; (14) \u2018partner country\u2019 means a country or territory that may benefit from Union support under the Instrument pursuant to Article 4. For the purposes of this Regulation, where reference is made to human rights, it shall be understood to include fundamental freedoms. Article 3 Objectives of the Instrument 1. The general objectives of the Instrument are to: (a) uphold and promote the Union\u2019s values, principles and fundamental interests worldwide, in order to pursue the objectives and principles of the Union\u2019s external action, as laid down in Article 3(5) and Articles 8 and 21 TEU, thus contributing to the reduction and, in the long term, the eradication of poverty, to consolidating, supporting and promoting democracy, the rule of law and respect for human rights, sustainable development and the fight against climate change and addressing irregular migration and forced displacement, including their root causes; (b) contribute to the promotion of multilateralism, the achievement of the international commitments and objectives that the Union has agreed to, in particular the SDGs, the 2030 Agenda and the Paris Agreement; (c) promote stronger partnerships with third countries, including with the European Neighbourhood Policy countries based on mutual interests and ownership with a view to fostering stabilisation, good governance and building resilience. 2. The specific objectives of the Instrument are: (a) to support and foster dialogue and cooperation with third countries and regions in the Neighbourhood, in Sub-Saharan Africa, in Asia and the Pacific, and in the Americas and the Caribbean; (b) to develop special strengthened partnerships and enhanced political cooperation with the European Neighbourhood Policy countries, founded on cooperation, peace and stability and a shared commitment to the universal values of democracy, the rule of law and respect for human rights, and aiming towards deep and sustainable democracy and progressive socio-economic integration as well as people-to-people contacts; (c) at global level: (i) to protect, promote and advance democracy, the rule of law, including accountability mechanisms, and human rights, including gender equality and the protection of human rights defenders, including in the most difficult circumstances and urgent situations; (ii) to support civil society organisations; (iii) to further stability and peace and prevent conflict, thereby contributing to the protection of civilians; and (iv) to address other global challenges such as climate change, the protection of biodiversity and the environment, as well as migration and mobility; (d) to respond rapidly to: (i) situations of crisis, instability and conflict, including those which may result from migratory flows and forced displacement, and hybrid threats; (ii) resilience challenges, including natural and man-made disasters, and linking of humanitarian aid and development action; and (iii) Union foreign policy needs and priorities. 3. The achievement of the objectives referred to in paragraphs 1 and 2 of this Article shall be measured using relevant indicators as referred to in Article 41. 4. At least 93 % of the expenditure under the Instrument shall fulfil the criteria for ODA, established by the Development Assistance Committee of the OECD, thus contributing to ODA collective commitments, including towards LDCs. The specificity of the expenditure related to the partner countries and territories listed in Annex I shall be taken into account. Article 4 Scope and structure 1. Union funding under the Instrument shall be implemented through: (a) geographic programmes; (b) thematic programmes; (c) rapid response actions. 2. The geographic programmes shall encompass country and multi-country cooperation in the following areas: (a) Neighbourhood; (b) Sub-Saharan Africa; (c) Asia and the Pacific; (d) Americas and the Caribbean. Geographic programmes may cover all third countries, except for candidates and potential candidates as defined in the IPA III Regulation and overseas countries and territories. Geographic programmes of a continental or trans-regional scope may also be established, in particular a pan-African programme covering African countries under points (a) and (b) of the first subparagraph and a programme covering African, Caribbean and Pacific countries under points (b), (c) and (d) of the first subparagraph. Geographic programmes in the Neighbourhood area may cover any country or territory listed in Annex I. In order to attain the objectives of the Instrument, geographic programmes shall be based on the areas of cooperation set out in Annex II. 3. The thematic programmes shall encompass actions linked to the pursuit of the SDGs at global level, in the following areas: (a) Human Rights and Democracy; (b) Civil Society Organisations; (c) Peace, Stability and Conflict Prevention; (d) Global Challenges. Thematic programmes may cover all third countries as well as overseas countries and territories. In order to attain the objectives of the Instrument, thematic programmes shall be based on the areas of intervention set out in Annex III. 4. The rapid response actions shall enable early action to: (a) contribute to peace, stability and conflict prevention in situations of urgency, emerging crisis, crisis and post-crisis, including those which may result from migratory flows and forced displacement; (b) contribute to strengthening the resilience of states, societies, communities and individuals and to linking humanitarian aid and development action and, where relevant, peacebuilding; (c) address Union foreign policy needs and priorities. Rapid response actions may cover all third countries as well as overseas countries and territories. In order to attain the objectives of the Instrument, rapid response actions shall be based on the areas of intervention set out in Annex IV. 5. Actions under the Instrument shall be implemented primarily through geographic programmes. Actions implemented through thematic programmes shall be complementary to actions funded under geographic programmes and shall support global and trans-regional initiatives aimed towards achieving internationally agreed goals, in particular the SDGs and the Paris Agreement, as well as protecting global public goods or addressing global challenges. Actions implemented through thematic programmes may also be undertaken where: (a) there is no geographic programme; (b) the geographic programme has been suspended; (c) there is no agreement on the action with the partner country concerned; or (d) the action cannot be adequately addressed by geographic programmes. Rapid response actions shall be complementary to geographic and thematic programmes. Rapid response actions shall be designed and implemented to enable, where relevant, their continuity under geographic or thematic programmes. 6. The Commission is empowered to adopt delegated acts in accordance with Article 44 to amend Annexes II, III and IV. 7. The Commission is empowered to adopt a delegated act in accordance with Article 44 by 31 December 2021, to supplement this Regulation with provisions setting out: (a) specific objectives and priority areas of cooperation drawn from the areas of cooperation for the geographic programmes in Annex II, including a prioritisation, for the following sub-regions: Neighbourhood South, Neighbourhood East, West Africa, East and Central Africa, Southern Africa and Indian Ocean, Middle East, Central Asia, South Asia, North and South East Asia, the Pacific, the Americas and the Caribbean; (b) indicative thematic targets for the geographic pillar; and (c) indicative financial allocations for West Africa, East and Central Africa, Southern Africa and Indian Ocean sub-regions. The delegated act referred to in the first subparagraph of this paragraph shall be reviewed at the mid-term evaluation referred to in Article 42(2). Article 5 Consistency, coherence, synergies and complementarity 1. In implementing the Instrument, consistency, coherence, synergies and complementarity with all areas of Union external action, including other external financing instruments, and with other relevant Union policies and programmes, as well as policy coherence for development shall be ensured. For that purpose, the Union shall take into account the impact of all internal and external policies on sustainable development and shall seek to promote increased synergies and complementarities in particular with trade policy, economic cooperation and other sectorial cooperation. 2. Actions falling within the scope of Regulation (EC) No 1257/96 shall not be funded under the Instrument. 3. Where appropriate, an action that has received a contribution under the Instrument may also receive a contribution from another Union programme, provided that the contributions do not cover the same costs. The Instrument may also contribute to measures established under other Union programmes, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. Article 6 Budget 1. The financial envelope for the implementation of the Instrument for the period from 1 January 2021 to 31 December 2027 shall be EUR 79 462 000 000 in current prices. 2. The financial envelope referred to in paragraph 1 shall be composed of: (a) EUR 60 388 000 000 for geographic programmes: \u2014 Neighbourhood: at least EUR 19 323 000 000, \u2014 Sub-Saharan Africa: at least EUR 29 181 000 000, \u2014 Asia and the Pacific: EUR 8 489 000 000, \u2014 Americas and the Caribbean: EUR 3 395 000 000; (b) EUR 6 358 000 000 for thematic programmes: \u2014 Human Rights and Democracy: EUR 1 362 000 000, \u2014 Civil Society Organisations: EUR 1 362 000 000, \u2014 Peace, Stability and Conflict Prevention: EUR 908 000 000, \u2014 Global Challenges: EUR 2 726 000 000; (c) EUR 3 182 000 000 for rapid response actions. 3. The emerging challenges and priorities cushion of EUR 9 534 000 000 shall increase the amounts referred to in points (a), (b) and (c) of paragraph 2 of this Article in accordance with Article 17. 4. The financial envelope referred to in point (a) of paragraph 2 shall correspond to at least 75 % of the financial envelope referred to in paragraph 1. 5. Actions under Article 9 shall be financed up to the amount of EUR 270 000 000. The Commission is empowered to adopt delegated acts in accordance with Article 44 to amend that amount. Article 7 Policy framework The association agreements, partnership and cooperation agreements, multilateral agreements to which the Union is a party, and other agreements that establish a legally binding relationship between the Union and partner countries as well as European Council conclusions, Council conclusions, summit declarations or conclusions of meetings with partner countries at the level of heads of state or government or ministers, European Parliament resolutions, communications of the Commission and the High Representative of the Union for Foreign Affairs and Security Policy (the \u2018High Representative\u2019) shall constitute the overall policy framework for the implementation of the Instrument. Article 8 General principles 1. The Union shall seek to promote, develop and consolidate the principles of democracy, good governance, the rule of law, respect for human rights, including their universality and indivisibility, and fundamental freedoms and respect for human dignity, the principles of equality and solidarity on which it is founded, through dialogue and cooperation with partner countries, regions and civil society, including through action in multilateral fora. 2. The Instrument shall apply a rights-based approach encompassing all human rights, whether civil and political or economic, social and cultural in order to integrate human rights principles, to support the right holders in claiming their rights, with a focus on poorer, marginalised and vulnerable people and groups, including persons with disabilities, and to assist partner countries in implementing their international human rights obligations. That approach shall be guided by the principles of \u2018leaving no one behind\u2019, equality and non-discrimination on any grounds. 3. The Instrument shall promote gender equality, women\u2019s and girls\u2019 rights and empowerment and non-discrimination on any grounds, through targeted and mainstreamed actions. It shall also give particular attention to the rights of the child and empowerment of youth. 4. The Instrument shall be implemented in full accordance with the Union commitment to the promotion, protection and fulfilment of all human rights and to the full and effective implementation of the Beijing Platform for Action and the Programme of Action of the ICPD and the outcomes of their review conferences and remains committed to sexual and reproductive health and rights, in this context. Having that in mind, the Instrument shall support the Union commitment to the promotion, protection and fulfilment of the right of every individual to have full control over, and decide freely and responsibly on matters related to their sexuality and sexual and reproductive health, free from discrimination, coercion and violence. It shall also support the need for universal access to quality and affordable comprehensive sexual and reproductive health information, education, including comprehensive sexuality education, and health-care services. 5. The Union shall support, as appropriate, the implementation of bilateral, regional and multilateral cooperation and dialogue, association and trade agreements, partnership agreements and triangular cooperation. The Union shall promote a multilateral and rules-based and values-based approach to global goods and challenges and shall cooperate with Member States, partner countries, international organisations and other donors in that respect. The Union shall promote effective multilateralism in fostering cooperation with international organisations and other donors. The Union shall take into account and take up in the regular political dialogue with partner countries their track record in implementing obligations and commitments, including the 2030 Agenda, international human rights conventions, and other conventions, including those on nuclear safety standards, international agreements, in particular the Paris Agreement, and contractual relations with the Union, in particular association agreements, partnership and cooperation agreements and trade agreements. 6. Cooperation between the Union and the Member States, on the one hand, and partner countries, on the other, shall be based on and shall promote the development effectiveness principles, where applicable, across all modalities, namely: ownership of development priorities by partner countries, a focus on results, inclusive development partnerships, transparency and mutual accountability. The Union shall promote effective and efficient resource mobilisation and use. In line with the principle of inclusive partnership and transparency, where appropriate, the Commission shall ensure that relevant stakeholders of partner countries, including civil society organisations and local authorities, are duly consulted and have timely access to relevant information allowing them to be adequately involved and play a meaningful role in the design, implementation and associated monitoring processes of programmes. Where appropriate, the Commission shall also ensure that an enhanced dialogue is pursued with the private sector. In line with the principle of ownership, the Commission, where appropriate, shall favour the use of partner countries\u2019 institutions and systems for the implementation of programmes. 7. In order to promote the complementarity and efficiency of their action and initiatives, the Union and the Member States shall ensure the coordination of their policies and shall regularly consult each other on their assistance programmes, including in international organisations and during international conferences. The Union and the Member States shall coordinate their respective support programmes with the aim of increasing effectiveness and efficiency. The Union shall foster inclusiveness in the implementation of the Instrument and collaboration with Member States, seeking to maximise added value and taking into account experience and capacities, thus reinforcing shared interests, values and common goals. The Union shall encourage the exchange of best practices and knowledge sharing among Member States\u2019 bodies and experts. 8. Programmes and actions under the Instrument shall mainstream the fight against climate change, environmental protection, human rights, democracy, gender equality and, where relevant, disaster risk reduction, and shall address interlinkages between the SDGs, to promote integrated actions that can create co-benefits and meet multiple objectives in a coherent way. Those programmes and actions shall be based on a comprehensive multi-disciplinary analysis of context, capacities, risks and vulnerabilities, integrate a resilience approach and be conflict sensitive, taking into account conflict prevention and peacebuilding. They shall be guided by the principles of \u2018do no harm\u2019 and of \u2018leaving no one behind\u2019. 9. The Instrument shall promote the use of digitalisation as a powerful enabler for sustainable development and inclusive growth. 10. A more coordinated, holistic and structured approach to migration shall be pursued with partners, taking into account the importance of addressing the root causes of irregular migration and forced displacement. It shall maximise synergies and build comprehensive partnerships, while paying specific attention to countries of origin and transit. That approach shall combine all appropriate tools and the necessary leverage through a flexible incitative approach with, as appropriate within this context, possible changes in allocation of funding related to migration in accordance with the programming principles of the Instrument. It shall take into account effective cooperation and implementation of Union agreements and dialogues on migration. Those actions shall be implemented in full respect of international law, including international human rights and refugee law, Union and national competences. The effectiveness of that approach shall be assessed annually or as necessary. Migration-related actions pursuant to the Instrument shall be implemented in support of Union migration policy objectives through a flexible funding mechanism. 11. The Commission shall ensure that actions adopted under the Instrument in relation to the fight against terrorism and organised crime, cyber security and the fight against cybercrime, and capacity building of military actors in support of development and security for development are implemented in accordance with international law, including international human rights and humanitarian law. To that end, the Commission shall establish an appropriate risk assessment and monitoring framework. In that framework, the Commission shall develop operational guidance to ensure that human rights are taken into consideration in the design and implementation of those actions. Such actions shall be based on regular and robust conflict analysis to ensure conflict sensitivity and to implement a security sector reform approach that contributes to democratic governance, accountability and human security, including benefits for the local population. Those measures shall be embedded, where relevant, in the context of longer term assistance aimed at reforming the security sector. 12. The Commission shall regularly inform the European Parliament and the Council and, at the initiative of any of those three institutions, have exchanges of views with them, including on the incentive-based approach responding to performance in key areas, referred to in Article 20. The European Parliament may hold regular exchanges of views with the Commission regarding its own assistance programmes, on matters such as capacity building, including related mediation and dialogue, and election observation. 13. The Commission shall exchange information on a regular basis with civil society. 14. Where appropriate, the Commission shall develop and follow risk management frameworks, including assessment and mitigation measures. 15. Union funding under the Instrument shall not be used to finance the procurement of arms or ammunition, or operations having military or defence implications. Article 9 Capacity building of military actors in support of development and security for development 1. In order to contribute to sustainable development, which requires the achievement of stable, peaceful and inclusive societies, Union assistance under the Instrument may be used in the context of a wider security sector reform or to build the capacity of military actors in partner countries, under the exceptional circumstances set out in paragraph 3, to deliver development activities and security for development activities. 2. Assistance pursuant to this Article may cover in particular the provision of capacity building programmes in support of development and security for development, including training, mentoring and advice, as well as the provision of equipment, infrastructure improvements and services directly related to that assistance. 3. Assistance pursuant to this Article shall be provided only: (a) where requirements cannot be met by recourse to non-military actors to adequately reach Union objectives under the Instrument and there is a threat to the existence of functioning State institutions or to the protection of human rights and fundamental freedoms and State institutions cannot cope with that threat; and (b) where a consensus exists between the partner country concerned and the Union that military actors are key for preserving, establishing or re-establishing the conditions essential for sustainable development, including in crises and fragile or destabilised contexts and situations. 4. Union assistance pursuant to this Article shall not be used to finance capacity building of military actors for purposes other than the delivery of development activities and security for development activities. In particular, it shall not be used to finance any of the following: (a) recurrent military expenditure; (b) the procurement of arms and ammunition, or any other equipment designed to deliver lethal force; (c) training which is designed to contribute specifically to the fighting capacity of the armed forces. 5. When designing and implementing measures pursuant to this Article, the Commission shall promote ownership by the partner country. It shall also develop the necessary elements and the good practices required to ensure sustainability and accountability in the medium and long term and shall promote the rule of law and established international law principles. TITLE II IMPLEMENTATION OF THE INSTRUMENT CHAPTER I Programming Article 10 Scope of the geographic programmes 1. In order to attain the objectives of the Instrument geographic programmes shall be drawn up from the following areas of cooperation: (a) good governance, democracy, the rule of law and human rights, including gender equality; (b) eradicating poverty, fighting against inequalities and discrimination, and promoting human development; (c) migration, forced displacement and mobility; (d) environment and climate change; (e) inclusive and sustainable economic growth and decent employment; (f) peace, stability and conflict prevention; (g) partnership. 2. Further details on each of the areas of cooperation referred to in paragraph 1 are set out in Annex II. Article 11 Scope of the thematic programmes 1. In order to attain the objectives of the Instrument, thematic programmes shall cover the following areas of intervention: (a) Human Rights and Democracy: advancing: (i) the fundamental values of democracy; (ii) the rule of law; (iii) the universality, indivisibility and interdependence of human rights; (iv) respect for human dignity; (v) the principles of non-discrimination, equality and solidarity; (vi) respect for the principles of the Charter of the UN and international human rights law; (b) Civil Society Organisations: (i) inclusive, participatory, empowered and independent civil society and democratic space in partner countries; (ii) inclusive and open dialogue with and between civil society actors; (iii) awareness, understanding, knowledge and engagement of European citizens regarding development issues; (c) Peace, Stability and Conflict Prevention: (i) assistance for conflict prevention, peacebuilding and crisis preparedness; (ii) assistance in addressing global and trans-regional threats and emerging threats; (d) Global Challenges: (i) health; (ii) education; (iii) gender equality and women\u2019s and girls\u2019 empowerment; (iv) children and youth; (v) migration, forced displacement and mobility; (vi) decent work, social protection, inequality and inclusion; (vii) culture; (viii) ensuring a healthy environment and tackling climate change; (ix) sustainable energy; (x) sustainable and inclusive growth, decent jobs and private sector engagement; (xi) food and nutrition security; (xii) strengthen the role of local authorities as actors of development; (xiii) promote inclusive societies and multi-stakeholder initiatives, good economic governance, including fair and inclusive domestic revenue mobilisation; (xiv) support the assessment and documentation of progress in implementing partnership and effectiveness principles. 2. Further details on each of the areas of cooperation referred to in paragraph 1 are set out in Annex III. Article 12 General programming approach 1. Cooperation and interventions under the Instrument shall be programmed, except for rapid response actions referred to in Article 4(4). 2. On the basis of Article 7, programming under the Instrument shall be based on the following: (a) programming documents shall provide a coherent framework for cooperation between the Union and partner countries or regions, consistent with the overall purpose and scope, objectives and principles set out in this Regulation; (b) when drawing up the programming documents for partner countries and regions in situations of crisis, post-crisis or fragility and vulnerability a conflict analysis shall be conducted to ensure conflict sensitivity and due account shall be taken of the special needs and circumstances of the partner countries or regions concerned and of their population; where partner countries or regions are directly involved in, or affected by a situation of crisis, post-crisis or fragility, special emphasis shall be placed on stepping up coordination amongst all relevant actors to help with the transition from an emergency situation to sustainable development and stable peace, including the prevention of violence; (c) the Union and the Member States shall ensure inclusive consultations with each other at an early stage of and throughout the programming process in order to promote coherence, complementarity and consistency among their cooperation activities; joint programming shall be the preferred approach for country programming and its implementation shall be flexible, inclusive and driven at country level. Joint programming shall be open to other relevant donors and actors if the Union and the Member States consider this to be relevant; in addition, the Union and the Member States shall, whenever appropriate, seek to support partner countries through joint implementation; (d) the Union shall at an early stage of and throughout the programming process encourage a regular multi-stakeholder and inclusive dialogue with other donors and actors, including local authorities, representatives of civil society, foundations and the private sector, where relevant, in order to facilitate their respective contributions, as appropriate, and to ensure they play a meaningful role in the programming process; (e) the Human Rights and Democracy thematic programme and the Civil Society Organisations thematic programme referred to in points (a) and (b) of Article 4(3), respectively, shall provide assistance independently of the consent of governments and other public authorities of the third countries concerned; these thematic programmes shall mainly support civil society actors at all levels, taking into account forms and methods of implementation, as referred to in Article 27(3). The European Parliament and the Council shall be informed about the outcome of the consultations envisaged under points (c) and (d) of the first subparagraph. 3. Programming documents shall be results-based and include, wherever possible, clear targets and indicators. Indicators shall be based, where appropriate, on internationally agreed targets and indicators, in particular those set out for the SDGs, as well as country-level result frameworks, to assess and communicate the Union contribution to results, at the level of outputs, outcomes and impact. Article 13 Programming principles for geographic programmes 1. Programming of geographic programmes shall be based on the following principles: (a) without prejudice to paragraph 5, actions shall be based, to the extent possible, on an early, continuous and inclusive dialogue between the Union, Member States and the partner countries concerned, including national, regional and local authorities, involving civil society organisations, national, regional and local parliaments and other stakeholders, in order to enhance democratic ownership of the process and to encourage support for national and regional strategies; (b) where appropriate, the programming period shall be synchronised and aligned with the strategy cycles of partner countries; (c) programming may envisage cooperation activities funded from different allocations set out in Article 6(2) and from other Union programmes according to their basic acts. 2. Programming of geographic programmes shall provide a specific, tailor-made framework for cooperation based on: (a) the partners\u2019 needs, established on the basis of specific criteria, taking into account the population, poverty, inequality, human development, economic and environmental vulnerability, and state and societal resilience and the impact of protracted and recurrent crises; (b) the partners\u2019 capacity and commitment to promote shared values, principles and interests, including human rights, fundamental freedoms, democracy, the rule of law, good governance, fight against corruption, open civic space and gender equality and to support common goals and multilateral alliances and cooperation, a rules-based international system, as well as the advancement of Union priorities; (c) the partners\u2019 commitments, including those jointly agreed with the Union, and performance established on the basis of criteria such as political reform; and economic and social development, environmental sustainability, and the effective use of aid, taking into account the specificities and development level of partner countries; (d) the potential impact of Union funding in partner countries and regions; (e) the partners\u2019 capacities to mobilise and make effective use of domestic resources as well as to access financial resources, to manage resources transparently in support of national development priorities and their absorption capacities. 3. The countries most in need, in particular the LDCs, low income countries, countries in a situation of crisis, post-crisis, or fragility and vulnerability, including small islands developing states and landlocked developing countries, shall be given priority in the resource allocation process. 4. In addition, the Union shall address the specific challenges of middle income countries and in particular countries that graduate from lower income status. 5. Cooperation with industrialised countries shall focus on the promotion of Union and mutual interests and values, as well as commonly agreed objectives and multilateralism. 6. The Instrument shall contribute to actions established under Regulation (EU) 2021/817. A single programming document shall be drawn up from this Regulation for seven years, including funds from the IPA III Regulation. Regulation (EU) 2021/817 shall apply to the use of those funds. Article 14 Programming documents for geographic programmes 1. The implementation of the Instrument shall be carried out for geographic programmes through multiannual country and multi-country indicative programmes. 2. Multiannual indicative programmes shall set out the priority areas selected for Union financing, the specific objectives, the expected results, clear and specific performance indicators, and the indicative financial allocations, both overall and per priority area and, where applicable, the methods of implementation. 3. The multiannual indicative programmes shall be built on: (a) a national or regional strategy in the form of a development plan or a similar document accepted by the Commission as a basis for the corresponding multiannual indicative programme, at the time of adoption of the latter document; (b) a framework document laying down the Union policy towards the partner or partners concerned, including a joint document between the Union and Member States; (c) a joint document between the Union and the partner or partners concerned setting out common priorities and mutual commitments. 4. To increase the impact of collective cooperation of the Union, where possible and appropriate, a joint programming document shall replace the Union\u2019s and Member States programming documents. However, such a joint programming document shall only replace the Union\u2019s multiannual indicative programme, provided it is approved in the implementing act adopted in accordance with Article 16, complies with Articles 12 and 13, contains the elements set out in paragraph 2 of this Article and sets out the division of labour between the Union and the Member States. Article 15 Programming documents for thematic programmes 1. The implementation of the Instrument shall be carried out for thematic programmes through multiannual indicative programmes. 2. Multiannual indicative programmes for thematic programmes shall set out the Union\u2019s strategy, the priorities selected for Union financing, the specific objectives, the expected results, clear and specific performance indicators, the international situation, and the activities of the main partners for the theme concerned. Where applicable, resources and intervention priorities shall be laid down for participation in global initiatives. 3. Multiannual indicative programmes for thematic programmes shall set out the indicative financial allocation, overall, by area of cooperation and by priority. The indicative financial allocation may be given in the form of a range. Article 16 Adoption and amendment of multiannual indicative programmes 1. The Commission shall adopt, by means of implementing acts, multiannual indicative programmes referred to in Articles 14 and 15. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(2). That procedure shall also apply to reviews referred to in paragraphs 3 and 4 of this Article, which have the effect of significantly modifying the content of the multiannual indicative programme. 2. When adopting joint multiannual programming documents referred to in Article 14, the Commission decision shall apply only to the Union\u2019s contribution to the joint multiannual programming document. 3. Multiannual indicative programmes for geographic programmes shall be reviewed following the mid-term evaluation referred to in Article 42(2), as well as on an ad hoc basis as necessary for effective implementation, in particular where there are substantive changes in the policy framework referred to in Article 7 or following a situation of crisis or post-crisis. 4. Multiannual indicative programmes for thematic programmes shall be reviewed following the mid-term evaluation referred to in Article 42(2), as well as on an ad hoc basis as necessary for effective implementation, in particular where there are substantive changes in the policy framework referred to in Article 7. 5. On duly justified imperative grounds of urgency, such as crises or immediate threats to peace, democracy, the rule of law, human rights or fundamental freedoms, the Commission may amend multiannual indicative programmes referred to in Articles 14 and 15 by means of implementing acts. Those implementing acts shall be adopted in accordance with the urgency procedure referred to in Article 45(4). Article 17 Emerging challenges and priorities cushion 1. The amount referred to in Article 6(3) shall be used where most needed and duly justified, inter alia: (a) to ensure an appropriate response of the Union in the event of unforeseen circumstances; (b) to address new needs or emerging challenges, such as those at the Union\u2019s or its neighbours\u2019 borders linked to crisis, whether natural or man-made, violent conflict and post-crisis situations or migratory pressure and forced displacement; (c) to promote new Union led or international initiatives or priorities. 2. The use of those funds shall be decided in accordance with the procedures established in Articles 16 and 25. CHAPTER II Specific provisions for the Neighbourhood area Article 18 Specific objectives for the Neighbourhood area In accordance with Articles 3 and 4, the specific objectives of Union support under the Instrument for the Neighbourhood area are to: (a) promote enhanced political cooperation and strengthen and consolidate deep and sustainable democracy, stability, good governance, the rule of law and the respect for human rights; (b) support the implementation of association agreements or other existing and future agreements, and jointly agreed association agendas and partnership priorities or equivalent documents, including through institutional cooperation and capacity building; (c) promote a strengthened partnership with societies between the Union and the partner countries, and among the partner countries, including through people-to-people contacts and a wide range of activities with a specific focus on youth; (d) enhance regional and cross-border cooperation, in particular in the framework of the Eastern Partnership, the Union for the Mediterranean, European Neighbourhood-wide collaboration as well as Black Sea regional cooperation, Arctic cooperation, the Northern Dimension, including in the areas of energy and security; (e) achieve progressive integration into the Union internal market and enhanced sectoral and cross-sectoral cooperation, including through legislative approximation and regulatory convergence towards Union and other relevant international norms and standards, and improved market access, including through deep and comprehensive free trade areas, related institution building and investment; (f) strengthen partnerships on well-managed and safe migration and mobility and, where applicable and provided that conditions for well-managed and secure mobility are in place, support the implementation of existing visa-free regimes, in line with the revised visa suspension mechanism, visa liberalisation dialogues and bilateral or regional agreements and arrangements with third countries, including mobility partnerships; (g) support confidence-building and other measures contributing to security, the prevention and settlement of conflicts, including support to affected populations and reconstruction. Article 19 Programming documents and allocation criteria 1. For partner countries and territories listed in Annex I, priority areas for Union financing shall be selected mainly from those included in the association, partnership and cooperation agreements, jointly agreed association agendas and partnership priorities or other relevant, existing and future, jointly agreed documents referred to in point (c) of Article 14(3), between the Union and the partner countries in bilateral and multilateral formats, including, as relevant, within the Eastern Partnership and the southern dimension of the European Neighbourhood Policy, in accordance with the specific objectives laid down in Article 18 and the areas of cooperation for the geographic programmes set out in Annex II. 2. By way of derogation from Article 13(2) and (3), Union support under geographic programmes in the Neighbourhood area shall be differentiated in form and in amounts, taking into account the partner country\u2019s: (a) needs, using indicators such as population, inequalities and level of development; (b) commitment to and progress in implementing jointly agreed political, economic, environmental and social reform objectives; (c) commitment to and progress in building deep and sustainable democracy, the rule of law, good governance, human rights, and the fight against corruption; (d) partnership with the Union, including the level of ambition for that partnership; (e) absorption capacity and potential impact of Union support under the Instrument. 3. The Union support referred to in paragraph 2 of this Article shall be reflected in the programming documents for the geographic programmes referred to in Article 14. Article 20 Incentive-based approach 1. Indicatively 10 % of the financial envelope set out in the first indent of point (a) of Article 6(2) to supplement the country indicative financial allocations referred to in Article 14 shall be allocated to the partner countries and territories listed in Annex I as an incentive towards reforms. Such allocations shall be decided on the basis of their performance and progress towards democracy, good governance and the rule of law including cooperation with civil society, human rights including gender equality, cooperation on migration, economic governance and reforms, in particular those reforms that have been jointly agreed. The progress of the partner countries shall be regularly assessed, in particular by means of progress reports which include trends as compared to previous years. 2. Paragraph 1 shall not apply to support to civil society, conflict prevention and peacebuilding, people-to-people contacts, including cooperation between local authorities, support for the improvement of human rights or crisis-related support measures. In the event of serious or persistent degradation of democracy, human rights or the rule of law, or an increased risk of conflict, support to those actions shall be increased, where possible and appropriate. Article 21 Multi-country indicative programmes Multi-country indicative programmes in the Neighbourhood area shall address challenges common to all or a number of partner countries, based on priorities of the Eastern Partnership and the southern dimension of the reviewed European Neighbourhood Policy and taking into account the work carried out in the context of the Union for the Mediterranean, and regional, trans-regional and sub-regional cooperation, primarily between two or more partner countries, including also within the framework of the Northern Dimension and Black Sea Synergy regional cooperation. Article 22 Cross-border Cooperation 1. Cross-border cooperation, as defined in point (5) of the first paragraph of Article 2, shall cover cooperation along external adjacent land and maritime borders, transnational cooperation over larger transnational territories or around sea-basins, as well as interregional cooperation. 2. The Neighbourhood area shall contribute to cross-border cooperation programmes as referred to in paragraph 1 co-financed by the European Regional Development Fund in the framework of the Interreg Regulation. Up to 5 % of the financial envelope for the Neighbourhood area shall be indicatively allocated to support those programmes. 3. Contributions to cross-border cooperation programmes shall be determined and used pursuant to Article 10(3) of the Interreg Regulation. 4. The Union co-financing rate shall not be higher than 90 % of the eligible expenditure of a cross-border cooperation programme. 5. Pre-financing for cross-border cooperation programmes may exceed the percentage referred to in Article 51 of the Interreg Regulation. At the request of the managing authority, for each financial year, the pre-financing rate may be up to 80 % of annual commitments to the programme. 6. A multiannual strategy document for cross-border cooperation, setting out the elements referred to in Article 14(2) of this Regulation, shall be adopted in accordance with Article 10(1) of the Interreg Regulation. 7. Where cross-border cooperation programmes are discontinued in accordance with Article 12 of the Interreg Regulation, support from the financial envelope for the Neighbourhood area to the discontinued programme that remains available may primarily be used to finance other cross-border cooperation programmes or any other activity under that financial envelope as appropriate. CHAPTER III Action plans, measures and implementing methods Article 23 Action plans and measures 1. The Commission shall adopt annual or multiannual action plans and measures. The measures may take the form of individual measures, special measures, support measures or exceptional assistance measures. Action plans and measures shall take into account the specific context and shall specify for each action the objectives pursued, the expected results and main activities, the methods of implementation, monitoring and evaluation as well as the budget and any associated support expenditures. 2. Action plans shall be based on programming documents, except for cases referred to in paragraphs 5 and 6. Action plans shall be prepared in an inclusive, transparent and timely manner. Whenever appropriate, action plans shall be discussed jointly with Member States in the context of \u2018working better together\u2019. 3. Where necessary, an action may be adopted as an individual measure before or after the adoption of action plans. Individual measures shall be based on programming documents, except for cases referred to in paragraph 5 and in other duly justified cases. 4. In the event of unforeseen needs or circumstances, and where funding is not possible from more appropriate sources, the Commission may adopt special measures not provided for in the programming documents. 5. Annual or multiannual action plans and individual measures may be used to implement rapid response actions referred to in points (b) and (c) of Article 4(4). 6. The Commission may adopt exceptional assistance measures for rapid response actions as referred to in point (a) of Article 4(4). An exceptional assistance measure may have a duration of up to 18 months, which may be extended twice by a further period of up to six months, up to a total maximum duration of 30 months, in the event of objective and unforeseen obstacles to its implementation, provided that there is no increase in the financial amount of the measure. In cases of protracted crisis and conflict, the Commission may adopt a second exceptional assistance measure of a duration of up to 18 months. In duly justified cases, further measures may be adopted where the continuity of the Union\u2019s action is essential and cannot be ensured by other means. Article 24 Support measures 1. Union financing may cover support expenditure for the implementation of the Instrument and for the achievement of its objectives, including administrative support associated with the preparation, follow-up, monitoring, control, audit and evaluation activities necessary for such implementation, as well as expenditure at headquarters and Union delegations for the administrative and coordination support needed for the Instrument, and to manage operations financed under the Instrument, including information and communication actions, and corporate information technology systems. 2. Where support expenditure is not included in the action plans or measures referred to in Article 23, the Commission shall adopt support measures, where applicable. Union financing under support measures may cover: (a) studies, meetings, information, awareness-raising, training, preparation and exchange of lessons learnt and best practices, publication activities and any other administrative or technical assistance expenditure necessary for the programming and management of actions, including remunerated external experts; (b) research and innovation activities and studies on relevant issues and the dissemination thereof; (c) expenditure related to the provision of information and communication actions, including the development of communication strategies and corporate communication and visibility of the political priorities of the Union. Article 25 Adoption of action plans and measures 1. Action plans and measures shall be adopted by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(2). 2. The procedure referred to in paragraph 1 shall not be required for: (a) individual measures for which the Union\u2019s funding does not exceed EUR 5 000 000; (b) special and support measures as well as action plans adopted in order to implement rapid response actions for which the Union\u2019s funding does not exceed EUR 10 000 000; (c) exceptional assistance measures referred to in Article 23(4) for which the Union\u2019s funding does not exceed EUR 20 000 000; (d) technical amendments to action plans and measures, provided such amendments do not substantially affect the objectives of the action plan or measure concerned, such as: (i) change of method of implementation; (ii) extensions of the implementation period; (iii) reassignments of funds between actions contained in an action plan; (iv) increases or reductions of the budget of action plans and measures by not more than 20 % of the initial budget and not exceeding EUR 10 000 000. In case of multiannual action plans and measures, the thresholds referred to in points (a), (b) and (c) and point (d)(iv) of the first subparagraph of paragraph 2 shall be applicable on a yearly basis. When adopted in accordance with this paragraph, action plans and measures, except exceptional assistance measures, and technical amendments shall be communicated to the European Parliament and to the Member States through the relevant committee referred to in Article 45 within one month of their adoption. 3. Before the adoption or extension of exceptional assistance measures not exceeding EUR 20 000 000, the Commission shall inform the European Parliament and the Council of their nature and objectives and of the financial amounts envisaged. The Commission shall inform the European Parliament and the Council before making significant substantive changes to exceptional assistance measures already adopted. The Commission shall take account of the relevant policy approach for the planning and subsequent implementation of such measures, in the interest of consistency of the Union\u2019s external action. 4. Where duly justified, imperative grounds of urgency, such as crises, including natural or man-made disasters, or immediate threats to democracy, the rule of law, human rights or fundamental freedoms so require, the Commission may adopt action plans and measures or amendments to existing action plans and measures, as immediately applicable implementing acts, in accordance with the procedure referred to in Article 45(4). 5. Appropriate environmental screening, including for climate change and biodiversity impacts, shall be undertaken at the level of actions, in accordance with the applicable legislative acts of the Union, including Directive 2011/92/EU of the European Parliament and of the Council (42) and Council Directive 85/337/EEC (43), comprising, where applicable, an environmental impact assessment, including the impact on climate change, ecosystems and biodiversity, for environmentally sensitive actions, in particular for major new infrastructure. Other appropriate ex ante assessments which are proportionate to the objectives and amounts of the envisaged actions and measures shall be carried out, to determine the possible implications and risks of those actions and measures with regard to human rights, access to natural resources such as land, and social standards including in the form of impact assessments for major actions and measures that are expected to have a significant impact on those areas. Where relevant, strategic environmental assessments, including the impact on climate change, shall be used in the implementation of sectoral programmes. The involvement of interested stakeholders in environmental assessments and public access to the results of such assessments shall be ensured. Article 26 Methods of cooperation 1. As provided for by the Financial Regulation, the Commission shall implement financing under the Instrument - either directly by the Commission, by Union delegations or by executive agencies, or indirectly through any of the entities listed in point (c) of Article 62(1) of that Regulation. 2. Financing under the Instrument may also be provided through contributions to international, regional or national funds, such as those established or managed by the EIB, by Member States, by partner countries and regions, by international organisations or by other donors. 3. The entities listed in point (c) of Article 62(1) of the Financial Regulation and eligible counterparts referred to in Article 35(4) of this Regulation shall fulfil their reporting obligations under Article 155 of the Financial Regulation annually. The reporting requirements for any of those entities are laid down in the financial framework partnership agreement, the contribution agreement, the agreement on budgetary guarantees or the financing agreement. 4. Actions financed under the Instrument may be implemented by means of parallel or joint co-financing. 5. In the case of parallel co-financing, an action is split into a number of clearly identifiable components which are each financed by the different partners providing co-financing in such a way that the end-use of the financing can always be identified and duplication of financing is avoided. 6. In the case of joint co-financing, the total cost of an action shall be shared between the partners providing the co-financing and the resources are pooled in such a way that it is no longer possible to identify the source of financing for any given activity undertaken as part of the action. 7. Cooperation between the Union and its partners may take the form of, for example: (a) triangular arrangements whereby the Union coordinates with third countries its assistance funding to a partner country or region; (b) administrative and technical cooperation measures, as well as building capacity, including to share transitional or reform implementation experiences of Member States, such as decentralised cooperation through partnerships or twinning, between public institutions, including local authorities, public law bodies or private law entities entrusted with public service tasks of a Member State and those of a partner country or region, as well as cooperation measures involving public sector experts dispatched from the Member States and their regional and local authorities; (c) contributions to the necessary costs of setting up and administering a public-private partnership, including those for their independent assessment and monitoring, where possible by civil society organisations; (d) sector policy support programmes whereby the Union provides support to a partner country\u2019s sector programme; (e) contributions to the cost of the countries\u2019 participation in Union programmes, and to actions implemented by Union agencies and bodies, as well as to bodies or persons entrusted with the implementation of specific actions in the Common Foreign and Security Policy pursuant to Title V TEU. Article 27 Forms of Union funding 1. Union funding may be provided through the types of financing envisaged by the Financial Regulation and in particular: (a) grants; (b) procurement contracts for services, supplies or works; (c) budget support; (d) contributions to trust funds set up by the Commission, in accordance with Article 234 of the Financial Regulation; (e) financial instruments; (f) budgetary guarantees; (g) blending operations; (h) debt relief in the context of internationally agreed debt relief programme; (i) financial assistance; (j) remunerated external experts. 2. When working with stakeholders of partner countries such as civil society organisations and local authorities, the Commission shall take into account their specificities, including their needs and the relevant context, when defining the financing modalities, the type of contribution, the award modalities and the administrative provisions for the management of grants, with a view to reaching and best responding to the widest possible range of such stakeholders. Specific modalities shall be encouraged in accordance with the Financial Regulation, such as partnership agreements, authorisations of financial support to third parties, direct award or eligibility-restricted calls for proposals, or lump sums, unit costs and flat-rate financing as well as financing not linked to costs as envisaged in Article 125(1) of the Financial Regulation. 3. In addition to the cases referred to in Article 195 of the Financial Regulation, the direct award procedure may be used for: (a) low-value grants to human rights defenders to finance urgent protection actions and needs, including through mechanisms for the protection of human rights defenders at risk, as well as to mediators and other civil society actors involved in crisis and armed conflict related dialogue, conflict resolution, reconciliation and peacebuilding, where appropriate without the need for co-financing; (b) grants, where appropriate without the need for co-financing, to finance actions in the most difficult conditions where the publication of a call for proposals would be inappropriate, including situations where there is a serious lack of fundamental freedoms, including violation of human rights, threats to democratic institutions, escalation of crisis or armed conflict, where human security is most at risk or where human rights organisations and defenders, mediators and other civil society actors involved in crisis and armed conflict related dialogue, reconciliation and peacebuilding operate under the most difficult conditions; such grants shall not exceed EUR 1 000 000 and their duration shall not exceed 18 months, which may be extended by a further 12 months in the event of objective and unforeseen obstacles to their implementation; (c) grants to the Office of the UN High Commissioner for Human Rights as well as to Global Campus of Human Rights, the European Inter-University Centre for Human Rights and Democratisation, providing a European Master\u2019s Degree in Human Rights and Democratisation, and its associated network of universities delivering human rights postgraduate diplomas, including scholarships to students and human rights defenders from third countries; (d) low value grants to civil society organisations using, to the extent possible, simplified forms of financing in accordance with Article 125 of the Financial Regulation. Budget support, including through sector reform performance contracts, shall be based on country ownership, mutual accountability and the commitment of partner countries, taking into account their record and progress with regard to universal values, democracy, human rights and the rule of law, and aims to strengthen partnerships between the Union and partner countries. It shall include reinforced policy dialogue, capacity building and improved governance, complementing partners\u2019 efforts to collect more and to spend better in order to support sustainable, inclusive growth and decent job creation, including for young people, poverty eradication, inequality reduction, and to build and consolidate democracies and peaceful societies. Budget support shall also contribute to gender equality. Any decision to provide budget support shall be based on budget support policies agreed by the Union, a clear set of eligibility criteria and a careful assessment of the risks and benefits. 4. Budget support shall be differentiated in such a way as to respond better to the political, economic, social and environmental context of the partner country, taking into account situations of fragility. When providing budget support in accordance with Article 236 of the Financial Regulation, the Commission shall clearly define and monitor criteria for budget support conditionality, including progress in reforms and transparency, and shall support the development of parliamentary control, national audit capacities and increased transparency and public access to information. 5. Disbursement of the budget support shall be based on indicators demonstrating satisfactory progress being made towards achieving the objectives agreed with the partner country. 6. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, in duly justified cases specified in the financing decision, activities supported under the Instrument and the underlying costs incurred in 2021 may be considered eligible as of 1 January 2021, even if those activities were implemented and those costs were incurred before the grant application was submitted. 7. Financial instruments, budgetary guarantees and blending operations under the Instrument shall be implemented in accordance with the principles laid down in Article 209(1) of the Financial Regulation and whenever possible under the lead of the EIB, a multilateral European finance institution, such as the European Bank for Reconstruction and Development, or a bilateral European finance institution, such as development banks, possibly pooled with additional other forms of financial support, both from Member States and third parties. Contributions to financial instruments under the Instrument may be made by Member States as well as any entity referred to in point (c) of Article 62(1) of the Financial Regulation. 8. Financial instruments referred to in paragraph 7 may be grouped into facilities for implementation and reporting purposes. 9. The Union funding shall not generate or activate the collection of specific taxes, duties or charges. 10. Taxes, duties and charges imposed by partner countries may be eligible for financing under the Instrument. Article 28 Eligible persons and entities 1. Participation in procurement, grant and prize award procedures for actions financed under geographic programmes and under the Civil Society Organisations thematic programme and the Global Challenges thematic programme shall be open to international organisations and to all other legal entities, including civil society organisations, who are nationals of and, in the case of legal persons, who are also effectively established in, the following countries: (a) Member States, beneficiaries listed in the relevant Annex to the IPA III Regulation and contracting parties to the Agreement on the European Economic Area; (b) Neighbourhood partner countries and the Russian Federation when the relevant procedure takes place in the context of the programmes referred to in Annex I in which it participates; (c) developing countries and territories, as included in the list of ODA recipients published by the OECD Development Assistance Committee, which are not members of the G-20 group, and overseas countries and territories; (d) developing countries, as included in the list of ODA recipients, which are members of the G-20 group, and other countries and territories, when the relevant procedure takes place in the context of an action financed by the Union under the Instrument in which they participate; (e) countries for which reciprocal access to external funding is established by the Commission; that access may be granted, for a limited period of at least one year, whenever a country grants eligibility on equal terms to entities from the Union and from countries eligible under the Instrument; the Commission shall decide on the reciprocal access and on its duration after consultation of the recipient country or countries concerned; (f) member countries of the OECD, in the case of contracts implemented in a LDC or a highly indebted poor country, as included in the list of ODA recipients. 2. Without prejudice to the limitations inherent to the nature and objectives of the action, participation in procurement, grant and prize award procedures for actions financed under the Human Rights and Democracy thematic programme and the Peace, Stability and Conflict Prevention thematic programme as well as rapid response actions, shall be open without limitations. 3. All supplies and materials financed under the Instrument may originate from any country. 4. The eligibility rules laid down in this Article shall not apply to, and shall not create nationality restrictions for, natural persons employed or otherwise legally contracted by an eligible contractor or, where applicable, subcontractor. 5. For actions jointly co-financed by an entity, or implemented in direct or indirect management with entities as referred to in points (c)(ii) to (viii) of Article 62(1) of the Financial Regulation, the eligibility rules of those entities shall also apply. 6. Where donors provide financing to a trust fund established by the Commission or through external assigned revenues, the eligibility rules in the constitutive act of the trust fund or, in the case of external assigned revenues, in the agreement with the donor, shall apply. 7. In the case of actions financed under the Instrument and under another Union programme, eligible entities under any of those Union programmes shall be considered eligible. 8. In the case of multi-country actions, legal entities who are nationals of and, in the case of legal persons, who are also effectively established in, the countries and territories covered by the action may be considered eligible. 9. The eligibility rules laid down in this Article may be restricted with regard to the nationality, geographical location or nature of applicants, where such restrictions are required on account of the specific nature and the objectives of the action and where they are necessary for its effective implementation. 10. Tenderers, applicants and candidates from non-eligible countries may be accepted as eligible in the case of urgency or the unavailability of services in the markets of the countries or territories concerned, or in other duly substantiated cases where application of the eligibility rules would make the realisation of an action impossible or exceedingly difficult. 11. In order to promote local capacities, markets and purchases, where the Financial Regulation provides for an award on the basis of a single tender, priority shall be given to local and regional contractors. In all other cases, participation of local and regional contractors shall be promoted in accordance with the relevant provisions of that Regulation. Sustainability and due diligence criteria shall be promoted. 12. Under the Human Rights and Democracy thematic programme, any entity not covered under the definition of legal entity in point 6 of the first paragraph of Article 2 shall be eligible when this is necessary to pursue the areas of intervention of this programme. Article 29 Excluded activities Union funding under the Instrument shall not support actions or measures which: (a) may result in the violation of human rights in partner countries; (b) are incompatible with the recipient country\u2019s Nationally Determined Contribution (NDC) under the Paris Agreement, or that promote investments in fossil fuels, or that, according to the environmental screening and impact assessment, cause significant adverse effects on the environment or the climate, unless such actions or measures are strictly necessary to achieve the objectives of the Instrument and they are accompanied with appropriate measures to avoid, prevent or reduce and, if possible, off-set these effects, including support to phase out environmentally harmful fossil fuel subsidies. Article 30 Carry-overs, annual instalments, commitment appropriations, re-payments and revenue generated by financial instruments and budgetary guarantees 1. In addition to Article 12(4) of the Financial Regulation, unused commitment and payment appropriations under the Instrument shall be automatically carried-over and may be committed and used, respectively, up to 31 December of the following financial year. The amount carried over shall be used first in the following financial year. The Commission shall inform the European Parliament and the Council of commitment appropriations carried-over in accordance with Article 12(6) of the Financial Regulation. 2. In addition to the rules laid down in Article 15 of the Financial Regulation on making appropriations available again, commitment appropriations corresponding to the amount of decommitments made as a result of total or partial non-implementation of an action under the Instrument shall be made available again to the benefit of the budget line of origin. 3. Budgetary commitments for actions extending over more than one financial year may be broken down over several years into annual instalments, in accordance with Article 112(2) of the Financial Regulation. The third subparagraph of Article 114(2) of the Financial Regulation shall not apply to the multiannual actions referred to in the first subparagraph of this paragraph. The Commission shall automatically decommit any portion of a budgetary commitment for an action which, by 31 December of the fifth year following that of the budgetary commitment, has not been used for the purpose of pre-financing or making interim payments, or for which no certified statement of expenditure or any payment request has been submitted. Paragraph 2 of this Article shall also apply to annual instalments. 4. By way of derogation from Article 209(3) of the Financial Regulation, repayments and revenues generated by a financial instrument and budgetary guarantees shall be assigned to the budget line of origin as internal assigned revenue after deduction of management costs and fees. Every five years, the Commission shall examine the contribution made to the achievement of Union objectives by, and the effectiveness of, existing financial instruments. CHAPTER IV EFSD+, the External Action Guarantee, budgetary guarantees and financial assistance to third countries Article 31 Scope and financing 1. The financial envelope referred to in point (a) of Article (6)(2) shall cover the European Fund for Sustainable Development Plus (EFSD+) and the External Action Guarantee. 2. The purpose of the EFSD+ as an integrated financial package supplying financial capacity in the form of grants, technical assistance, financial instruments, budgetary guarantees and blending operations referred to in Article 27(1) of this Regulation shall be to support investments and increase access to financing, as a means of contributing to the achievement of the objectives and general principles laid down in Articles 3 and 8 of this Regulation, and, where relevant, the objectives of the IPA III Regulation while maximising additionality and development impact and delivering innovative products, including to SMEs. The EFSD+ shall in particular foster sustainable and inclusive economic, environmental and social development, transition into sustainable value-added economy and a stable investment environment. It shall also promote socio-economic and environmental resilience in partner countries with a particular focus on the eradication of poverty. The EFSD+ shall thus contribute to the reduction of socio-economic inequalities, sustainable and inclusive growth, climate change adaptation and mitigation, environmental protection and management, the creation of decent jobs on the basis of the core ILO labour standards, economic opportunities, skills and entrepreneurship, socio-economic sectors, including social enterprises and cooperatives, SMEs, sustainable connectivity, the support to vulnerable groups, the promotion of human rights, gender equality and the empowerment of women and young people, as well as addressing specific socio-economic root causes of irregular migration and root causes of forced displacement, in accordance with the priority areas outlined in Annex V and relevant indicative programming documents. Special attention shall be given to countries identified as experiencing fragility or conflict, LDCs and heavily indebted poor countries, including by providing support for institutional capacity building, economic governance and technical assistance. 3. The External Action Guarantee shall support the EFSD+ operations covered by budgetary guarantees in accordance with Articles 32 to 39 of this Regulation. The External Action Guarantee shall also support macro-financial assistance and loans to third countries referred to in Article 10(2) of Regulation (Euratom) 2021/948. 4. Under the External Action Guarantee, the Union may guarantee operations, under Guarantee agreements signed between 1 January 2021 and 31 December 2027, up to EUR 53 449 000 000. The Commission is empowered to adopt a delegated act in accordance with Article 44 to amend the maximum amount of the External Action Guarantee by up to 20 %. 5. The provisioning rate shall range between 9 % and 50 % depending on the type of operations. A maximum amount of EUR 10 000 000 000 from the Union budget may be used to provision the External Action Guarantee. The Commission is empowered to adopt delegated acts in accordance with Article 44 to amend this maximum amount to ensure that the provisioning amount reflects the amount and the provisioning rates of the External Action Guarantee, taking into account the type of guaranteed operations. The provisioning rate for the External Action Guarantee shall be 9 % for the Union\u2019s macro-financial assistance and for budgetary guarantees covering sovereign risks associated with lending operations. The provisioning rates shall be reviewed at least every three years from the date of application of this Regulation laid down in Article 51. The Commission is empowered to adopt delegated acts in accordance with Article 44 to amend the provisioning rates. 6. The External Action Guarantee shall be considered as a single guarantee in the common provisioning fund established by Article 212 of the Financial Regulation. 7. The EFSD+ and the External Action Guarantee may support financing and investment operations in partner countries in the geographical areas referred to in Article 4(2). The provisioning of the External Action Guarantee shall be financed from the budget of the relevant geographic programmes established by point (a) of Article 6(2) and shall be transferred into the common provisioning fund. The EFSD+ and the External Action Guarantee may also support operations in beneficiaries listed in the relevant Annex to the IPA III Regulation. The funding for those operations under the EFSD+ and for the provisioning of the External Action Guarantee shall be financed from the IPA III Regulation. The provisioning of the External Action Guarantee for loans to third countries referred to in Article 10(2) of Regulation (Euratom) 2021/948 shall be financed from that Regulation. 8. The provisioning referred to in Article 211(2) of the Financial Regulation shall be constituted on the basis of the Union\u2019s total liabilities authorised under this Regulation. The annual amount of provisioning required may be constituted during a period not exceeding seven years. The provisioning of guarantees authorised under Regulation (EU) 2017/1601 and of guarantees, financial assistance and Euratom loans to third countries authorised under basic acts whose provisioning is governed by Regulation (EC, Euratom) No 480/2009 shall continue to follow the provisions of those Regulations. 9. The net assets on 31 July 2021 of the EFSD Guarantee Fund and of the Guarantee fund for external actions established by Regulation (EU) 2017/1601 and Regulation (EC, Euratom) No 480/2009, respectively, shall be transferred into the common provisioning fund for the purpose of provisioning the budgetary guarantees authorised under Regulation (EU) 2017/1601 and the guarantees, financial assistance and Euratom loans to third countries authorised under basic acts whose provisioning is governed by Regulation (EC, Euratom) No 480/2009. Article 32 Structure of the EFSD+ 1. The EFSD+ shall be composed of regional investment platforms within the regional areas laid down in Article 4(2) of this Regulation and in the IPA III Regulation and established on the basis of the working methods, procedures and structures of the existing external blending facilities of the Union, which may combine their blending operations and External Action Guarantee operations under the EFSD+. 2. The Commission shall ensure the management of the EFSD+. Article 33 The EFSD+ strategic board 1. In ensuring the management of the EFSD+, the Commission shall be advised by a strategic board (the \u2018EFSD+ strategic board\u2019), except in the case of the operations covering the Western Balkans\u2019 beneficiaries listed in the relevant Annex to the IPA III Regulation, which shall have its specific strategic board. 2. The EFSD+ strategic board shall advise the Commission on the strategic orientation and priorities of External Action Guarantee investments under the EFSD+, including for the investment windows referred to in Article 36, and contribute to their alignment with the guiding principles and objectives of the Union\u2019s external action, development policy, European Neighbourhood Policy, as well as with the objectives set out in Article 3 and the purpose of the EFSD+ as set out in Article 31. The EFSD+ strategic board shall also support the Commission in setting overall investment goals as regards the use of the External Action Guarantee to support EFSD+ operations and monitor an appropriate and diversified geographical and thematic coverage for investment windows. 3. The EFSD+ strategic board shall also support overall coordination, complementarity, and coherence between the regional investment platforms, between the three pillars of the External Investment Plan, between the External Investment Plan and the Union\u2019s other efforts on migration and on the implementation of the 2030 Agenda, including the fight against climate change, as well as with Union external programmes and financing instruments. 4. The EFSD+ strategic board shall be composed of representatives of the Commission and of the High Representative, of all Member States and of the EIB. The European Parliament shall have observer status. Contributors, eligible counterparts, partner countries, relevant regional organisations and other stakeholders may be given observer status, where appropriate. The EFSD+ strategic board shall be consulted prior to the inclusion of any new observer. The EFSD+ strategic board shall be co-chaired by the Commission and the High Representative. 5. The EFSD+ strategic board shall meet at least twice a year and, when possible, adopt opinions by consensus. Additional meetings may be organised at any time by the chair or at the request of one third of its members. Where consensus cannot be reached, the voting rights as agreed during the first meeting of the EFSD+ strategic board and laid down in its rules of procedure shall apply. The rules of procedure shall set out the framework regarding the role of observers. The minutes and agendas of the meetings of the EFSD+ strategic board shall, following their adoption, be made public. 6. The Commission shall report annually to the EFSD+ strategic board about the progress made in respect of the implementation of the EFSD+. The strategic board covering the Western Balkans shall inform on progress made on the implementation of the guarantee instrument for that region to complement the abovementioned reporting. The strategic boards shall examine the evaluation reports referred to in Article 42(5) and shall take them into account. The EFSD+ strategic board shall regularly organise a consultation of relevant stakeholders on the strategic orientation and implementation of the EFSD+. 7. The existence of the EFSD+ strategic board and the strategic board covering the Western Balkans shall not influence the need to have a single, unified EFSD+ risk management framework. 8. The risk management function for guarantees under the EFSD+ shall take into account the objectives and principles of the Instrument. Risk assessment and remuneration methodologies under EFSD+ shall be consistently applied to all investment windows, including those referred to in Article 36. A technical risk assessment group shall be established by the Commission. The Commission shall ensure an independent, impartial and inclusive high-quality function of the technical risk assessment group. The Commission shall also ensure that information and analysis are shared in a timely, transparent and inclusive manner with all Member States, with due regard to confidentiality. The composition, rules of procedure and working methods of the technical risk assessment group shall be inclusive, open to experts from the EIB, other eligible counterparts and interested Member States, and shall be presented to the EFSD+ strategic board. The Commission shall disclose to the European Parliament and the Council the composition, terms of reference and rules of procedure of the technical risk assessment group and ensure the impartiality and absence of conflict of interest of its members. 9. During the application period of the EFSD+, the EFSD+ strategic board shall, as soon as possible, adopt and publish guidelines setting out how conformity of EFSD+ operations with the purpose, objectives and eligibility criteria set out in Articles 31 and 35 is to be ensured. Article 34 Regional operational boards The operational boards of regional investment platforms, taking into account the advice of the strategic board concerned and relevant risk assessments, shall support the Commission at the implementation level in defining regional and sectoral investment goals and regional, sectoral, and thematic investment windows and shall formulate opinions on blending operations and on the use of the External Action Guarantee covering EFSD+ proposed investment programmes. Article 35 Eligibility and selection of operations and counterparts for the External Action Guarantee under the EFSD+ 1. The financing and investment operations eligible for support through the External Action Guarantee shall be consistent and aligned with Union policies, the relevant programming documents, as well as with the partner countries\u2019 strategies and policies. They shall in particular support the objectives, general principles and policy framework of the Instrument and, where relevant, the IPA III Regulation, with due regard to the priority areas laid down in Annex V to this Regulation. 2. The External Action Guarantee shall support financing and investment operations which comply with the conditions set out in points (a) to (e) of Article 209(2) of the Financial Regulation concerning in particular the need to achieve additionality, including by addressing market failures or sub-optimal investment situations, alignment of interest of the eligible counterparts, avoiding the distortion of competition, and, where appropriate, maximising private investment, and which: (a) undergo, in line with Article 34 of the Financial Regulation, ex ante evaluations which shall be proportionate to the objectives and amounts of the envisaged operations to determine the possible implications and risks of these operations with regard to human rights, environmental, labour and social standards including in the form of impact assessments for major programmes that are expected to have a significant impact on these areas, in line with the purpose of the EFSD+ laid down in Article 31(2) of this Regulation and taking due account of the principle of free and prior informed consent of affected communities in land related investments; (b) ensure complementarity within the different pillars of the External Investment Plan as well as with other initiatives; (c) are economically and financially viable, with due regard to the possible support from, and co-financing by, private and public partners to the project, while taking into account the specific operating environment and capacities of countries identified as experiencing fragility or conflict, LDCs, small island developing states, landlocked developing countries and heavily indebted poor countries which may benefit from more concessional terms; (d) are technically viable and are sustainable from an environmental and social point of view and maximise development impact; (e) do not distort markets in partner countries and regions and do not compete unfairly with local actors; (f) are implemented in accordance with the policy framework referred to in Article 7, applicable environmental, social and labour law obligations and standards and internationally agreed guidelines, principles and conventions on investments, in particular those adopted by the UN and the OECD, with full respect for international human rights law as well as in accordance with the objectives and general principles laid down in Articles 3 and 8. 3. The External Action Guarantee shall be used to cover the risks for the following instruments: (a) loans, including local currency loans; (b) guarantees; (c) counter-guarantees; (d) capital market instruments; (e) any other form of funding or credit enhancement, insurance, and equity or quasi-equity participations. 4. The eligible counterparts for the purposes of the External Action Guarantee shall be those identified in Article 208(4) of the Financial Regulation, including those from partner countries and third countries contributing to the External Action Guarantee, subject to approval by the Commission in accordance with Article 37 of this Regulation. In addition, and by derogation from point (c) of Article 62(1) of the Financial Regulation, bodies governed by private law of a Member State, a partner country or a third country which has contributed to the External Action Guarantee in accordance with Article 37 of this Regulation, and which provide adequate assurance of their financial capacity shall be eligible for the purpose of the External Action Guarantee. 5. Eligible counterparts shall comply with the rules and conditions provided for in point (c) of Article 62(1) of the Financial Regulation. In the case of bodies governed by private law of a Member State, a partner country or a third country which have contributed to the External Action Guarantee in accordance with Article 37 of this Regulation, preference shall be given to those bodies that disclose information related to environment, social, tax and corporate governance criteria. The Commission shall ensure the effective, efficient and fair use of available resources among eligible counterparts, including small and medium-sized counterparts, while promoting cooperation between them and taking due account of their capacities, added value and experience. The Commission shall ensure fair treatment for all eligible counterparts, in accordance with Article 27(7), and shall ensure that conflicts of interest are avoided throughout the implementation period of the EFSD+. In order to ensure complementarity, the Commission may request any relevant information from eligible counterparts about their non-EFSD+ operations. 6. The condition set out in Article 219(4) of the Financial Regulation on contributions with own resources shall apply to each eligible counterpart allocated with a budgetary guarantee under the Instrument on a portfolio basis. 7. The Commission shall select the eligible counterparts in accordance with Article 154 of the Financial Regulation, taking due account of: (a) the advice of the strategic and regional operational boards; (b) the objectives of the investment window; (c) the experience and risk management capacity of the eligible counterpart; (d) the amount of own and additional resources, as well as private sector co-financing, that the eligible counterpart is ready to mobilise for the investment window taking in due account the size of the investment; (e) the sectoral or geographic expertise of the eligible counterparts; (f) the benefits of promoting collaboration between eligible counterparts. 8. On the basis of the multiannual indicative programmes and of the advice provided by the EFSD+ strategic board and the strategic board covering the Western Balkans, the Commission shall, after consulting the regional operational boards and informing the European Parliament and the Council, set up investment windows for regions or specific partner countries, or both, for specific sectors, or for specific projects or specific categories of final beneficiaries, or both, which are to be funded under the Instrument, to be covered by the External Action Guarantee up to a fixed amount. The Commission shall inform the European Parliament and the Council on how the investment windows comply with this Article and on their detailed funding priorities. All requests for financial support within investment windows shall be made to the Commission. The choice of investment windows shall be duly justified by an analysis of the market failure or sub-optimal investment situations and an assessment of its alignment with the priorities of this Regulation and, where relevant, the IPA III Regulation. The Commission shall carry out that analysis in cooperation with potentially eligible counterparts and stakeholders. Eligible counterparts may provide the instruments referred to in paragraph 3 under an investment window or individual project administered by an eligible counterpart. Those instruments may be provided for the benefit of partner countries, including countries experiencing fragility or conflict, or countries facing challenges in reconstruction and post-conflict recovery, for the benefit of those partner countries\u2019 institutions, including their public national and private local banks and finance institutions, as well as for the benefit of private sector entities, including SMEs, of those partner countries. Those instruments shall not benefit companies controlled by the military or state security sector, except for duly justified cases. 9. The Commission shall assess the operations supported by the External Action Guarantee against the eligibility criteria set out in paragraphs 1, 2 and 3, where possible drawing on the existing result measurement systems of the Union and of eligible counterparts. The Commission shall establish a checklist of the eligibility criteria as set out in Article 31, Article 35(1) and (2) and shall assess and select all proposals to be supported by the External Action Guarantee against this checklist, on the basis of the information provided by the eligible counterparts. If necessary, the Commission shall ask the eligible counterparts to clarify or to amend the information provided. The Commission shall publish on an annual basis the checklists and the results of its assessment for each investment window broken down by country and sector. 10. The Commission is empowered to adopt delegated acts in accordance with Article 44 to amend the priority areas in Annex V. Article 36 Role of the EIB 1. The EIB shall implement an exclusive dedicated investment window covering a comprehensive risk cover for operations with sovereign counterparts and non-commercial sub-sovereign counterparts with an indicative minimum amount of EUR 11 000 000 000 which shall be programmed in accordance with the procedures laid down in Chapters I and III of this Title. The EIB shall have the exclusivity for operations with sovereign counterparts and non-commercial sub-sovereign counterparts under the exclusive dedicated investment window. Under the exclusive dedicated investment window, the own resources contribution shall be understood as the assumption of residual risk and the EU guarantee shall cover 65 % of the aggregate amount disbursed and guaranteed under EIB financing operations, less amounts reimbursed, plus all related amounts. By way of derogation from the second subparagraph, if the EIB cannot carry out or decides not to carry out operations under the exclusive dedicated investment window, the implementation of these operations shall be open to other eligible counterparts, in accordance with conditions which shall be laid down in the relevant External Action Guarantee agreements, which shall take into account the conditions offered to the EIB for the same type of operations and the specific needs, circumstances and nature of the eligible counterpart implementing these operations. 2. The EIB shall be eligible for implementing operations with sub-sovereign counterparts not covered under the exclusive dedicated investment window referred to in paragraph 1 and operations with the private sector. The procedure referred to in Article 35 shall be used to entrust the EIB, if appropriate, with two additional dedicated investment windows covering: (a) a non-exclusive comprehensive risk cover for operations with commercial sub-sovereign counterparts; and (b) non-exclusive operations for the promotion of foreign direct investment, trade and the internationalisation of partner countries\u2019 economies, providing a political risk cover for private sector operations. 3. The indicative amount for the dedicated investment windows referred to in paragraphs 1 and 2 shall be of EUR 26 725 000 000. In implementing the dedicated investment windows referred to in paragraphs 1 and 2, the EIB shall comply with this Regulation, including its overall objectives and those of the EFSD+ and, where relevant, of the IPA III Regulation, as well as with the relevant programming documents and the reporting obligations. 4. In accordance with point (f) of Article 209(2) of the Financial Regulation, due to the nature and policy objective of the exclusive dedicated investment window referred to in paragraph 1, the relevant External Action Guarantee agreement may provide that the Union shall not be remunerated for operations under that investment window. 5. For the purpose of this Article, sub-sovereign operations shall be considered commercial unless otherwise duly justified by the EIB and confirmed by the Commission. The operations under the dedicated investment window referred to in point (b) of paragraph 2 shall be coherent with those of the export credit agencies of Member States. 6. The EIB shall be subject to the opinion of the boards laid down in Articles 33 and 34, respectively. For EIB operations falling under the investment windows referred to in this Article, the eligibility assessment laid down in Article 35(9) shall be satisfied within the framework of the procedure provided for in Article 19 of Protocol No 5 on the Statute of the European Investment Bank, annexed to the TFEU. The EIB shall, in a timely manner, provide all information required by the Commission for that purpose. The EIB financing operations falling under those investment windows shall not be covered by the EU guarantee where the Commission delivers an unfavourable opinion under the procedure provided for in Article 19 of Protocol No 5 on the Statute of the European Investment Bank, annexed to the TFEU. All further modalities applicable to the EIB shall be established in the relevant External Action Guarantee agreements. 7. The EIB shall be eligible for implementing activities under other investment windows established under Article 35(8). 8. In compliance with this Regulation, including its objectives and principles and the relevant programming documents, as well as, where relevant, the IPA III Regulation, the Commission and the EIB shall conclude dedicated External Action Guarantee agreements for the dedicated investment windows referred to in paragraphs 1 and 2. Article 37 Contribution from other donors to the External Action Guarantee 1. Member States, third countries and other third parties may contribute to the External Action Guarantee. By derogation from the second subparagraph of Article 218(2) of the Financial Regulation, the contracting parties to the Agreement on the European Economic Area may provide contributions either in the form of guarantees or cash. Third countries other than the contracting parties to the Agreement on the European Economic Area and other third parties shall provide contributions in the form of cash and subject to the opinion of the EFSD+ strategic board and approval by the Commission. Member States may request that their contributions be earmarked for the initiation of actions in specific regions, countries, sectors or existing investment windows. The Commission shall inform the European Parliament and the Council without delay of the contributions approved 2. Contributions in the form of a guarantee shall not exceed 50 % of the amount referred to in Article 31(4). The contributions made by Member States and the contracting parties to the Agreement on the European Economic Area in the form of a guarantee may only be called for payments of guarantee calls after the funding from the general budget of the Union, increased by any other cash contributions, has been used on payments of guarantee calls. Any contribution may be used to cover guarantee calls regardless of earmarking. A contribution agreement shall be concluded between the Commission, on behalf of the Union, and the contributor, and shall contain, in particular, provisions concerning the payment conditions. Article 38 Implementation of External Action Guarantee agreements 1. On behalf of the Union, the Commission shall conclude External Action Guarantee agreements with the eligible counterparts selected pursuant to Article 35. Those agreements may be concluded with a consortium of two or more eligible counterparts. In compliance with Article 219(1) of the Financial Regulation, budgetary guarantees shall be irrevocable, unconditional and on demand for the types of operations covered under the External Action Guarantee. When concluding External Action Guarantee agreements, the Commission shall take due account of the advice and guidance of the boards and of the technical risk assessment group. 2. One or more External Action Guarantee agreements shall be concluded for each investment window between the Commission and the eligible counterpart or eligible counterparts selected. In addition, in order to address specific needs, the External Action Guarantee may be granted for individual financing or investment operations. The European Parliament and the Council shall be notified of the signature of all External Action Guarantee agreements. Upon their request, those agreements shall be made available to the European Parliament and the Council, taking into account the protection of confidential and commercially sensitive information. 3. External Action Guarantee agreements shall contain, in particular: (a) detailed rules on the coverage, requirements, eligibility, eligible counterparts, and procedures; (b) detailed rules on the provision of the External Action Guarantee, including its arrangements on the coverage and its defined coverage of portfolios and of projects of specific types of instruments, as well as a risk analysis of projects and project portfolios, including at sectoral, regional, and national levels; (c) a reference to the objectives and purpose of the Instrument, an assessment of the needs and an indication of the expected results, taking into account the promotion of corporate social responsibility and responsible business conduct, including in particular by the respect of internationally agreed guidelines, principles and conventions on investment referred to in point (f) of Article 35(2); (d) the remuneration of the External Action Guarantee, which is to reflect the risk level, and the possibility for the remuneration to be partly subsidised in order to give more concessional terms in duly justified cases; and, in particular to countries experiencing fragility or conflict, LDCs and heavily indebted poor countries; (e) requirements for the use of the External Action Guarantee, including payment conditions, such as specific time frames, interest to be paid on due amounts, expenses and recovery costs and possibly necessary liquidity arrangements; (f) claims procedures, including, but not limited to, triggering events and waiting periods, and procedures regarding the recovery of claims; (g) monitoring, reporting, transparency and evaluation obligations; (h) clear and accessible complaints procedures for third parties that could be affected by the implementation of projects supported by the External Action Guarantee. 4. The eligible counterpart shall approve financing and investment operations in accordance with its own rules and procedures and in compliance with the External Action Guarantee agreement. 5. The External Action Guarantee may cover: (a) for debt instruments, the principal and all interests and amounts due to the selected eligible counterpart, but not received by it in accordance with the terms of the financing operations after an event of default has occurred; (b) for equity investments, the amounts invested and their associated financing costs; (c) for other financing and investment operations referred to in Article 35(2), the amounts used and their associated funding costs; (d) all relevant expenses and recovery costs related to an event of default, unless deducted from recovery proceeds. 6. For the purposes of the Commission\u2019s accounting and its reporting of the risks covered by the External Action Guarantee, and in accordance with Article 209(4) of the Financial Regulation, eligible counterparts with which an External Action Guarantee agreement has been concluded shall provide the Commission and the Court of Auditors annually with the financial reports on financing and investment operations covered by this Regulation, audited by an independent external auditor, containing, inter alia, information on: (a) the risk assessment of financing and investment operations of the eligible counterparts, including information on Union liabilities measured in compliance with the accounting rules referred to in Article 80 of the Financial Regulation and International Public Sector Accounting Standards; (b) the outstanding financial obligation for the Union arising from the EFSD+ operations provided to the eligible counterparts and their financing and investment operations, broken down by individual operation. 7. The eligible counterparts shall, upon request, provide the Commission with any additional information necessary to fulfil the Commission\u2019s obligations pursuant to this Regulation, in particular with regard to the selection criteria set out in Article 35, including compliance with human rights, and social, labour and environment standards. 8. The Commission shall submit an annual report to the EFSD+ strategic board, to regional operational boards, to the European Parliament and to the Council on financial instruments, budgetary guarantees, including those implemented by the EIB, financial assistance in accordance with Article 41(4) and (5) and Articles 241 and 250 of the Financial Regulation. For that purpose, the eligible counterparts shall provide annually the information necessary to allow the Commission to comply with those reporting obligations. Article 39 Grievance and redress mechanism and protection of Union\u2019s financial interests 1. In view of possible grievances of third parties in partner countries, including communities and individuals affected by projects supported by the EFSD+ and the External Action Guarantee, the Commission and Union delegations shall publish on their websites direct references to the complaints mechanisms of the relevant counterparts that have concluded agreements with the Commission. The Commission shall also provide the possibility of directly receiving complaints related to the treatment of grievances by eligible counterparts. The Commission shall take that information into account in view of future cooperation with those counterparts. 2. Persons and entities implementing financial instruments and budgetary guarantees shall comply with applicable Union law and principles and agreed international and Union standards as laid down in Article 155(2) and (3) of the Financial Regulation. The Commission shall assess whether the systems, rules and procedures of those persons and entities ensure protection of the financial interests of the Union equivalent to that provided for where the Commission implements the Union budget, with due regard to the principle of proportionality, taking into account the nature of the action and the conditions under which this action is implemented. Article 40 Capital participation in development finance institutions The envelope for geographic programmes, referred to in point (a) of Article 6(2), may be used to contribute to the capital endowment of European and other development finance institutions. CHAPTER V Monitoring, reporting and evaluation Article 41 Monitoring and reporting 1. Indicators to report on progress of the Instrument towards the achievement of the specific objectives laid down in Article 3(2) are set out in Annex VI. Those indicators, in line with the SDGs indicators, shall be used together with data from evaluations and other existing results reporting, as a basis for assessing the extent to which those specific objectives have been achieved. 2. The Commission shall continuously monitor its actions and, at least on an annual basis, review progress made towards delivering the targets established by this Regulation, as well as expected results, covering outputs and outcomes. Progress regarding expected results shall be monitored in a transparent and timely manner, on the basis of relevant, measurable, qualitative and quantitative data including, but not limited to those set out in Annex VI. Whenever possible, indicators shall be disagregated by sex, age and other relevant factors. 3. Joint results frameworks included and agreed within joint programming documents that fulfil the criteria set out in Article 14(4) shall provide, where feasible, the basis for the joint monitoring by the Union and its Member States of their collective support to a partner country. The performance reporting system shall ensure that data for monitoring programme implementation and results of the Instrument are collected efficiently, effectively, and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds. 4. The Commission shall examine the progress made in implementing the Instrument. Starting from 2022 onwards, the Commission shall, in a timely manner by 30 November each year, submit to the European Parliament and to the Council an annual report on progress towards the achievement of the objectives of the Instrument by means of indicators, including, but not limited to, those set in Annex VI, reporting on the ongoing activities, results delivered and the effectiveness of the Regulation. That report shall also be submitted to the European Economic and Social Committee and to the Committee of the Regions. 5. The annual report shall contain: (a) information relating to the previous year on the measures financed; (b) the results of monitoring and evaluation exercises; (c) the involvement and level of cooperation of the relevant partners, broken down by type of entity as referred to in Article 62 of the Financial Regulation for both direct and indirect management; (d) the budgetary commitments, including contracted amounts, and payment appropriations, broken down by country, region and cooperation sector; (e) qualitative and quantitative information including on measures taken pursuant to Article 9, on the use of the emerging challenges and priorities cushion referred to in Article 17 and on the use of funds dedicated to the incentive-based approach responding to performance in key areas referred to in Article 20. The annual report shall assess the results of the Union funding using, as far as possible, specific and measurable indicators to show progress towards the targets and objectives of the Instrument as well as the progress made towards mainstreaming issues referred to in Article 8(8). It shall also present a breakdown on the forms of Union funding as set out in Article 27. In the case of development cooperation, the report shall also assess, where possible and relevant, the adherence to development effectiveness principles, including for innovative financial instruments. 6. The annual report prepared in 2021 shall contain consolidated information from annual reports concerning the period from 2014 to 2020 on all funding from the Regulations referred to in Article 50(2) of this Regulation, including external assigned revenues and contributions to trust funds, guarantees and a breakdown of spending by country, forms of Union funding, as set out in Article 27 of this Regulation, type of entity as referred to in Article 62 of the Financial Regulation for both direct and indirect management, commitments and payments. That annual report shall reflect the main lessons learnt and the follow-up to the recommendations of the external evaluative exercises carried out in previous years. 7. The Commission shall submit as part of the annual report detailed reporting on the financing and investment operations covered by the External Action Guarantee, and the functioning of the EFSD+, its management and its effective contribution to its objectives. It shall include the following elements: (a) an assessment of the results contributing to the purpose and objectives of the Instrument and, where relevant, other funding instruments as laid down in Article 31(7); (b) an assessment, on the basis of indicators in accordance with Articles 31(2) and 35(2), of the additionality and added value, the mobilisation of private sector resources including from SMEs, the type of private sector entities supported, the estimated and actual outputs and the outcomes and impact of the financing and investment operations covered by the External Action Guarantee under the EFSD+ on an aggregated basis, including the impact on decent job creation, and the eradication of poverty and on the way in which the specific socio-economic root causes of irregular migration and root causes of forced displacement are addressed; the assessment shall include an analysis of the risk measures and their impact on the financial and economic stability of the partners and a gender analysis of the operations covered based on evidence and data broken down by gender, country and sector where possible; (c) an assessment of the compliance of the operations supported by the External Action Guarantee under the EFSD+ with the internationally agreed development effectiveness principles; (d) an assessment of the leverage effect achieved by the operations covered; (e) an assessment of the synergies and complementarity between operations covered by the External Action Guarantee under the EFSD+, including those referred to in Article 36, and other pillars of the External Investment Plan based on relevant existing reports, with particular regard to progress made on good governance, including in the fight against corruption and illicit financial flows, respect for human rights, the rule of law and gender-responsive policies, as well as the boosting of entrepreneurship, the local business environment and local financial markets; (f) an assessment of the remuneration of the guarantees and of the implementation of Article 155(2) and (3) of the Financial Regulation; 8. An annual estimate of the overall spending related to climate action, desertification and biodiversity shall be made on the basis of the indicative programming documents adopted. The funding allocated under the Instrument shall be subject to an annual tracking system based on the methodology of the OECD, namely the \u2018environmental markers\u2019 and \u2018Rio markers\u2019, without excluding the use of more precise methodologies where these are available, integrated into the existing methodology for performance management of Union programmes, to quantify the expenditure related to environmental management and protection, climate action, desertification and biodiversity at the level of the action plans and measures referred to in Article 23 and recorded within evaluations and the annual report. The Commission shall make available information on development cooperation in accordance with recognised international standards such as those from the ILO and the OECD and by using the framework for a common standard developed by the International Aid Transparency Initiative. 9. To ensure effective assessment of progress of the Instrument towards the achievement of its objectives, the Commission is empowered to adopt delegated acts in accordance with Article 44 to amend Annex VI to review or complement the indicators where considered necessary and to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. Article 42 Evaluation 1. The Commission shall evaluate the impact and effectiveness of its actions per area of intervention, and the effectiveness of programming, where appropriate by means of independent external evaluations. The Commission shall take due account of proposals by the European Parliament or the Council for independent external evaluations. Where applicable, evaluations shall make use of the good practice principles of the OECD Development Assistance Committee, seeking to ascertain whether the specific objectives have been met and to formulate recommendations with a view to improving future actions. The Commission shall communicate the findings and conclusions of the evaluations accompanied by its observations and follow-up, to the European Parliament, to the Council and to the Member States. Evaluations may be discussed at the request of Member States pursuant to Article 45(7). The results shall feed into the preparation of programmes and actions and resource allocation. Those evaluations and follow-up shall be made publicly available. The Commission shall, to an appropriate extent, associate all relevant stakeholders, including beneficiaries, civil society actors and local authorities in the evaluation process of the Union\u2019s funding provided under the Instrument, and may, where appropriate, seek to undertake joint evaluations with the Member States and other partners with close involvement of the partner countries. 2. By 31 December 2024, the Commission shall submit a mid-term evaluation of the Instrument. It shall cover the period from 1 January 2021 until the launch of that evaluation. The mid-term evaluation shall be accompanied, if appropriate, by legislative proposals setting out necessary amendments to this Regulation. 3. The Commission shall carry out a final evaluation of the Instrument within the mid-term review of the following financial period. That evaluation shall analyse and assess the Union contribution to the achievement of the objectives of the Instrument, taking into account indicators measuring the results delivered and any findings and conclusions concerning the impact of the Instrument. 4. The mid-term and the final evaluations shall address efficiency, effectiveness, impact, sustainability, the added value, the scope for simplification, internal and external coherence, including complementarity and synergies, and the continued relevance of the objectives of the Instrument. Evaluations shall identify lessons learned. The evaluations shall assess the maximum amount of the External Action Guarantee laid down in Article 31(4) and include information on the added value of integrating previously separate instruments into one streamlined instrument. The mid-term and final evaluations shall also contain consolidated information from annual reports on all funding governed by this Regulation, including external assigned revenues and contributions to trust funds, offering a breakdown of spending by beneficiary country, forms of Union funding, and involvement of Member States and relevant partners, commitments and payments, as well as a breakdown per geographic programmes, thematic programmes and rapid response actions, including the use of funds mobilised from the emerging challenges and priorities cushion, as referred to in Article 6. The mid-term and final evaluations shall be undertaken for the specific purpose of improving Union funding. They shall inform decisions on the renewal, modification or suspension of the types of actions implemented under the Instrument. 5. In accordance with the specific reporting provisions in the Financial Regulation, by 31 December 2024 and every three years thereafter, the Commission shall evaluate, on the basis of an external evaluation, the use and the functioning of the External Action Guarantee, in particular its contribution to the overall objectives, the achieved results and additionality. The Commission shall submit that evaluation report to the European Parliament and to the Council. That evaluation report shall be accompanied by an opinion of the Court of Auditors. The evaluation report and the opinion of the Court of Auditors shall be made publicly available. TITLE III FINAL PROVISIONS Article 43 Extension of geographic scope 1. In duly justified cases and where the action to be implemented is of a global, trans-regional or regional nature, the Commission may decide, within the relevant multiannual indicative programmes or within the relevant action plans or measures to extend the scope of actions to countries and territories not covered by this Regulation pursuant to Article 4 in order to ensure the coherence and effectiveness of Union financing or to foster regional or trans-regional cooperation. 2. The Commission may include a specific financial allocation to assist partner countries and regions to strengthen their cooperation with neighbouring Union outermost regions and with overseas countries and territories. To that end, the Instrument, may contribute, where appropriate and on the basis of reciprocity and proportionality as regards the level of funding from the Decision on the Overseas Association, including Greenland or the Interreg Regulation, or both, to actions implemented by a partner country or region or any other entity under this Regulation, by a country, territory or any other entity under the Decision on the Overseas Association, including Greenland or by a Union outermost region in the frame of joint operational programmes or to interregional cooperation programmes or measures established and implemented under the Interreg Regulation. Article 44 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 4(6) and (7), Article 6(5), Article 31(4) and (5), Article 35(10) and Article 41(9) shall be conferred on the Commission for the period of validity of this Regulation. 3. The delegation of power referred to in Article 4(6) and (7), Article 6(5), Article 31(4) and (5), Article 35(10) and Article 41(9) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 4(6) and (7), Article 6(5), Article 31(4) and (5), Article 35(10) and Article 41(9) shall enter into force only if no objection has been expressed either by the European Parliament or to the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 45 Committee procedure 1. The Commission shall be assisted by the Neighbourhood, Development and International Cooperation Instrument committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. The committee may convene in different formats in charge of specific areas of cooperation and intervention, such as geographic, thematic and rapid response actions. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where the opinion of the committee is to be obtained by a written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so requests. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. 5. The adopted decision shall remain in force for the duration of the adopted or modified document, action programme or measure. 6. An observer from the EIB shall take part in the committee\u2019s proceedings with regard to questions concerning the EIB. 7. Member States may request the examination of any other matter concerning the implementation of the Instrument, in particular with regard to multi-annual programming documents including mid-term or ad hoc reviews and evaluations. Article 46 Information, communication and visibility 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting and reporting on the actions, and their results by highlighting the support received from the Union in a visible manner on communication material related to the actions supported under the Instrument, and by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. Agreements concluded with the recipients of Union funding shall contain obligations in that respect. 2. The Commission shall implement information and communication actions relating to the Instrument, to actions taken pursuant to the Instrument and to the results obtained. Financial resources allocated to the Instrument shall also contribute to the corporate communication of and reporting on the political priorities of the Union, insofar as those priorities are related to the objectives of the Instrument. 3. The Instrument shall support strategic communication and public diplomacy, including the fight against disinformation, with a view to communicating the values of the Union as well as the added value of, and results achieved by, the Union\u2019s actions. 4. The Commission shall make publicly available information on actions financed under the Instrument as referred to in Article 38 of the Financial Regulation, including as appropriate through a comprehensive single website. 5. The website referred to in paragraph 4 shall also include information on financing and investment operations and the essential elements of all External Action Guarantee agreements, including information on the legal identity of eligible counterparts, expected development benefits and complaints procedures, in accordance with point (h) of Article 38(3), taking into account the protection of confidential and commercially sensitive information. 6. Eligible EFSD + counterparts, in accordance with their transparency policies and Union rules on data protection and on access to documents and information, shall proactively and systematically make publicly available on their websites information relating to all financing and investment operations covered by the External Action Guarantee, relating in particular to the manner in which those operations contribute to the achievement of the objectives and requirements set out in this Regulation. Where possible, such information shall be broken down at project level. Such information shall always take into account the protection of confidential and commercially sensitive information. Eligible EFSD+ counterparts shall also publicise Union support in all information which they publish on financing and investment operations covered by the External Action Guarantee in accordance with this Regulation. Article 47 Derogation from visibility requirements Where security issues or political sensitivities may make it preferable or necessary to limit communication and visibility activities in certain countries or areas or during certain periods, the target audience and the visibility tools, products and channels to be used in promoting a given action shall be determined on a case-by-case basis, in consultation and agreement with the Union. Where rapid intervention is required in response to a sudden crisis, it is not necessary to produce a full communication and visibility plan immediately. In such situations, however, the Union\u2019s support shall nevertheless be appropriately indicated from the start. Article 48 European External Action Service clause This Regulation shall be applied in accordance with Decision 2010/427/EU, in particular Article 9 thereof. Article 49 Amendments to Decision No 466/2014/EU Decision No 466/2014/EU is amended as follows: (1) in Article 1, paragraph 5 is replaced by the following: \u20185. The EU guarantee shall cover EIB financing operations signed during the period from 1 January 2014 to 31 December 2021.\u2019; (2) in Article 20, the second paragraph is replaced by the following: \u2018By 31 December 2022, the Commission shall present to the European Parliament and to the Council a report on the application of this Decision.\u2019; (3) in Annex I, the last three paragraphs of point D are replaced by the following: \u2018Within the overall fixed ceiling, the EIB governing bodies may decide, after consulting the Commission, to reallocate amounts within and between regions.\u2019. Article 50 Repeal and transitional provisions 1. Without prejudice to Article 31(8) of this Regulation, Regulations (EC, Euratom) No 480/2009 and (EU) 2017/1601 are repealed with effect from 1 August 2021 and Decision No 466/2014/EU is repealed with effect from 1 January 2022. The financial envelope for the Instrument shall finance the provisioning of the budgetary guarantees authorised under Regulation (EU) 2017/1601 and of guarantees and financial assistance authorised under basic acts whose provisioning is governed by Regulation (EC, Euratom) No 480/2009. Provisioning for such guarantees in and financial assistance to beneficiaries listed in the relevant Annex to the IPA III Regulation shall be financed from that Regulation. 2. The financial envelope for the Instrument may also cover technical and administrative assistance expenditures necessary to ensure the transition between this Regulation and the measures adopted under Regulations (EC, Euratom) No 480/2009, (EU) No 230/2014, (EU) No 232/2014, (EU) No 233/2014, (EU) No 234/2014, (EU) No 235/2014, (EU) No 236/2014, (Euratom) No 237/2014 and (EU) 2017/1601 and Decision No 466/2014/EU. 3. The financial envelope for the Instrument may cover expenditures related to the preparation of any future related Regulation. 4. If necessary, appropriations may be entered in the budget beyond 2027 to cover the expenditures provided for in Article 24(1), to enable the management of actions not completed by 31 December 2027. Article 51 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 June 2021. For the European Parliament The President D. M. SASSOLI For the Council The President F. ANDR\u00c9 (1) OJ C 110, 22.3.2019, p. 163. (2) OJ C 86, 7.3.2019, p. 295. (3) OJ C 45, 4.2.2019, p. 1. (4) Position of the European Parliament of 27 March 2019 (not yet published in the Official Journal) and position of the Council at first reading of 26 May 2021 (OJ C 225, 11.6.2021, p. 1). Position of the European Parliament of 8 June 2021 (not yet published in the Official Journal). (5) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (6) Regulation (EU) No 230/2014 of the European Parliament and of the Council of 11 March 2014 establishing an instrument contributing to stability and peace (OJ L 77, 15.3.2014, p. 1). (7) Regulation (EU) No 232/2014 of the European Parliament and of the Council of 11 March 2014 establishing a European Neighbourhood Instrument (OJ L 77, 15.3.2014, p. 27). (8) Regulation (EU) No 233/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for development cooperation for the period 2014-2020 (OJ L 77, 15.3.2014, p. 44). (9) Regulation (EU) No 234/2014 of the European Parliament and of the Council of 11 March 2014 establishing a Partnership Instrument for cooperation with third countries (OJ L 77, 15.3.2014, p. 77). (10) Regulation (EU) No 235/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for democracy and human rights worldwide (OJ L 77, 15.3.2014, p. 85). (11) Regulation (EU) No 236/2014 of the European Parliament and of the Council of 11 March 2014 laying down common rules and procedures for the implementation of the Union\u2019s instruments for financing external action (OJ L 77, 15.3.2014, p. 95). (12) Regulation (EU) 2017/1601 of the European Parliament and of the Council of 26 September 2017 establishing the European Fund for Sustainable Development (EFSD), the EFSD Guarantee and the EFSD Guarantee Fund (OJ L 249, 27.9.2017, p. 1). (13) Decision No 466/2014/EU of the European Parliament and of the Council of 16 April 2014 granting an EU guarantee to the European Investment Bank against losses under financing operations supporting investment projects outside the Union (OJ L 135, 8.5.2014, p. 1). (14) Council Regulation (EC, Euratom) No 480/2009 of 25 May 2009 establishing a Guarantee Fund for external actions (OJ L 145, 10.6.2009, p. 10). (15) Council Regulation (Euratom) No 237/2014 of 13 December 2013 establishing an Instrument for Nuclear Safety Cooperation (OJ L 77, 15.3.2014, p. 109). (16) Council Regulation (EU) 2015/322 of 2 March 2015 on the implementation of the 11th European Development Fund (OJ L 58, 3.3.2015, p. 1). (17) Internal agreement between the Representatives of the Governments of the Member States of the European Union, meeting within the Council, on the financing of European Union aid under the multiannual financial framework for the period 2014 to 2020, in accordance with the ACP-EU Partnership Agreement, and on the allocation of financial assistance for the Overseas Countries and Territories to which Part Four of the Treaty on the Functioning of the European Union applies (OJ L 210, 6.8.2013, p. 1). (18) OJ L 282, 19.10.2016, p. 4. (19) OJ L 317, 15.12.2000, p. 3. The ACP-EU Partnership Agreement was amended by the Agreement signed in Luxembourg on 25 June 2005 (OJ L 209, 11.8.2005, p. 27) and by the Agreement signed in Ouagadougou on 22 June 2010 (OJ L 287, 4.11.2010, p. 3). (20) Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid (OJ L 163, 2.7.1996, p.1). (21) Council Regulation (Euratom) 2021/948 of 27 May 2021 establishing a European Instrument for International Nuclear Safety Cooperation complementing the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe on the basis of the Treaty establishing the European Atomic Energy Community, and repealing Regulation (Euratom) No 237/2014 (see page 79 of this Official Journal). (22) Council Decision (CFSP) 2021/ 509 of 22 March 2021 establishing a European Peace Facility, and repealing Decision (CFSP) 2015/528 (OJ L 102, 24.3.2021, p. 14). (23) Regulation (EU) 2021/817 of the European Parliament and of the Council of 20 May 2021 establishing \u2018Erasmus+\u2019: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 (OJ L 189, 28.5.2021, p. 1). (24) Regulation (EU) 2021/818 of the European Parliament and of the Council of 20 May 2021 establishing the Creative Europe Programme (2021 to 2027) and repealing Regulation (EU) No 1295/2013 (OJ L 189, 28.5.2021, p. 34). (25) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (26) OJ L 433 I, 22.12.2020, p. 28. (27) Regulation (EU) 2017/2306 of the European Parliament and of the Council of 12 December 2017 amending Regulation (EU) No 230/2014 establishing an instrument contributing to stability and peace (OJ L 335, 15.12.2017, p. 6). (28) Council Decision 77/270/Euratom of 29 March 1977 empowering the Commission to issue Euratom loans for the purpose of contributing to the financing of nuclear power stations (OJ L 88, 6.4.1977, p. 9). (29) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73). (30) OJ L 1, 3.1.1994, p. 3. (31) Council Common Position 2008/944/CFSP of 8 December 2008 defining common rules governing control of exports of military technology and equipment (OJ L 335, 13.12.2008, p. 99). (32) Regulation (EU) 2021/821 of the European Parliament and of the Council of 20 May 2021 setting up a Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use items (OJ L 206, 11.6.2021, p. 1). (33) Regulation (EU) 2019/125 of the European Parliament and of the Council of 16 January 2019 concerning trade in certain goods which could be used for capital punishment, torture or other cruel, inhuman or degrading treatment or punishment (OJ L 30, 31.1.2019, p. 1). (34) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (35) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (36) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (37) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (38) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2018s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (39) OJ L 123, 12.5.2016, p. 1. (40) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p.13). (41) Council Decision 2010/427/EU of 26 July 2010 establishing the organisation and functioning of the European External Action Service (OJ L 201, 3.8.2010, p. 30). (42) Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012. p. 1). (43) Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (OJ L 175, 5.7.1985. p. 40). ANNEX I LIST OF COUNTRIES AND TERRITORIES IN THE NEIGHBOURHOOD AREA Algeria Armenia Azerbaijan Belarus Egypt Georgia Israel Jordan Lebanon Libya The Republic of Moldova Morocco Occupied Palestinian Territory Syria Tunisia Ukraine Union support under this area may also be used for the purpose of enabling the Russian Federation to participate in cross-border cooperation programmes and in other relevant multi-country indicative programmes, including as referred to in Article 13(6) and Article 21. ANNEX II AREAS OF COOPERATION FOR THE GEOGRAPHIC PROGRAMMES For all geographic regions PEOPLE 1. Good governance, democracy, the rule of law and human rights, including gender equality (a) Strengthening and promoting democracy and inclusive democratic processes, the rule of law, the fight against corruption, governance and oversight, including transparent, inclusive and credible electoral processes as well as transparent, accountable, effective and inclusive institutions at all levels, including legislative bodies, an independent judiciary, strengthening a meaningful political participation and representation; (b) Strengthening the promotion, protection and fulfilment of human rights and fundamental freedoms in compliance with international human rights law, including the Universal Declaration of Human Rights; supporting and protecting human rights defenders; supporting and monitoring complaint and redress mechanisms with regard to human rights violations and abuses at national and local level; contributing to the implementation of global and regional instruments and frameworks, increasing the capacities of civil society in their implementation and monitoring; (c) Fighting against discrimination in all its forms, and promoting the principle of equality and non-discrimination, in particular gender equality, rights and empowerment of women and girls, the rights of the child, persons with disabilities, persons belonging to minorities, lesbian, gay, bisexual, trans and intersex (LGBTI) persons, and indigenous peoples as set out in the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP); (d) Supporting, strengthening and empowering a thriving civil society and its independent, active and multiple roles in political transitions, reform processes and democratic transformations, and promoting an open and enabling space for civil society and citizens\u2019 engagement in political life and in scrutiny of decision-making as well as countering the shrinking of democratic space; supporting and promoting the participation of all in political processes and public life; (e) Improving the pluralism, independence and professionalism of a free and independent media, as well as enhancing media literacy and tackling disinformation; strengthening digital rights, including rights to access information; strengthening the right to privacy and data protection; (f) Building resilience of states, societies, communities and individuals to political, economic, environmental, food, demographic and societal pressures and shocks, natural and man-made disasters and health crises including pandemics; (g) Strengthening the development of democratic and inclusive public institutions at international, national and sub-national levels, including local authorities; strengthening the capacity for gender-responsive budgeting and planning; as well as an independent, effective, efficient and accountable judicial system, the promotion of the rule of law, international justice, accountability and affordable access to justice for all; (h) Supporting public administration reform processes at national and sub-national levels, including through the use of citizen-centred eGovernment systems and other digital solutions for building robust, accountable and transparent public administration and service delivery systems, strengthening legal frameworks and institutional set up, national statistical systems and capacities, including with regard to disaggregating data by income, sex, age and other factors, sound public finance management including external audit, and contributing to the fight against corruption, tax avoidance, tax evasion and aggressive tax planning; (i) Supporting national and local governments and administrations to create the required infrastructure to enable all civil registrations (from birth through to death) to be accurately registered, and officially recognised, and duplicated documents to be published when necessary in order to ensure that all citizens officially exist and are able to exercise their fundamental rights; (j) Promoting inclusive, balanced and integrated territorial, rural and urban policies and development through strengthening public institutions and bodies at the national and sub-national levels, supporting capacity building of local authorities and mobilising their expertise to promote a territorial approach to local development including efficient decentralisation, fiscal decentralisation, and state restructuring processes; (k) Increasing transparency and accountability of public institutions at national and sub-national levels and publicly-owned enterprises and improving access for all to information on public affairs, strengthening public procurement including encouraging the development of environmental, social and economic sustainability criteria and targets and public finance management at regional, national and local level, supporting the development and deployment of eGovernance systems and strengthening service delivery; (l) Supporting the sustainable, accountable, conflict sensitive and transparent management of natural resource sectors and related revenues, and reforms to ensure fair, just, efficient and sustainable tax policies. 2. Eradicating poverty, fighting against inequalities and discrimination, and promoting human development (a) Eradicating poverty in all its dimensions, including through public services on health, nutrition, education and social protection, tackling discrimination and inequalities and leaving no one behind; (b) Supporting sustainable agriculture, forestry and fisheries to increase food security, create economic opportunities and jobs; (c) Enhancing efforts for the adoption of policies and appropriate investment to promote, protect and fulfil the rights of women and girls, young people and children, and persons with disabilities, to facilitate their engagement and meaningful participation in social, civic and economic life, and to ensure their full contribution to inclusive growth and sustainable development; (d) Promoting the respect, protection and fulfilment of the rights of women and girls and their empowerment, including economic, labour and social rights, land rights, as well as rights referred to in Article 8(4), eliminating sexual and gender-based violence in all forms, including harmful practices such as early, forced and child marriage and female genital mutilation; (e) Addressing the linkages of global demographic growth and demographic shifts to sustainable development in all relevant dimensions including gender equality, health, social protection, social cohesion, education and employment; (f) Paying special attention to those who are disadvantaged, vulnerable and marginalised, including children and youth, older persons, persons with disabilities, LGBTI persons, persons belonging to minorities and indigenous peoples, refugees, internally displaced people, persons affected by armed conflict and stateless persons; (g) Promoting an integrated approach to supporting communities, particularly the most marginalised, vulnerable, poorest and hardest to reach persons, including by improving universal access to basic needs and services, including in the health, education, nutrition and social protection fields; (h) Supporting the provision of a safe, nurturing environment for children as an important element for fostering a healthy young population able to reach its full potential. This includes promoting the transition from institutional to community-based care for children. It also includes giving children, particularly the most marginalised, the best start in life by investing in early childhood development and ensuring that children experiencing poverty or inequality have access to basic services such as health, nutrition, education and social protection; (i) Supporting universal access to sufficient, affordable, safe and nutritious food and healthy diets, particularly for those in the most vulnerable situations, inter alia children under the age of five, adolescents, both girls and boys, and women, especially during pregnancy and breastfeeding, as well as strengthening food and nutrition resilience and the continuum of care, particularly in countries facing protracted or recurrent crises; prevent stunting, wasting and other forms of malnutrition; fostering multi-sectoral, nutrition-sensitive approaches to agriculture; (j) Supporting universal access to safe and sufficient drinking water sanitation, and hygiene, and sustainable and integrated water management, in particular at local level; (k) Achieving universal health coverage, with equitable access for all individuals and communities to quality and affordable health services, including sexual and reproductive health care services in the context of the implementation of the Beijing Platform for Action and the Programme of Action of the ICPD and the outcomes of their review conferences, through supporting the building of inclusive strong, quality and resilient health systems that are accessible to all, and enhancing capacity for early warning, risk reduction, management and recovery; complementing action through the Union\u2019s framework programme for research and innovation to tackle global health threats, develop safe, efficient and affordable vaccines, medicines and treatments against poverty-related and neglected diseases, and to improve responses to health challenges including communicable diseases, antimicrobial resistance and emerging diseases and epidemics; (l) Supporting universal and equitable social protection and strengthening social safety nets, support networks and systems to guarantee basic income, prevent lapses into extreme poverty and build resilience; (m) Promoting inclusive sustainable urban development to address urban inequality, focusing on those most in need; (n) Supporting local authorities, including through decentralised cooperation, capacity development and resource mobilisation, to improve in urban and rural areas the localisation of the SDGs through the delivery and responsiveness of basic services and equitable access to food and nutrition security, accessible, decent and affordable housing and the quality of life, in particular for those living in informal settlements and slums, strengthening and promoting accessible participation and complaint mechanisms, especially for disadvantaged and excluded persons and groups; (o) Promoting the achievement of internationally agreed goals in education, with particular focus on strengthening free education systems, through inclusive and equitable quality formal, informal and non-formal education and promoting life-long learning opportunities for all, and at all levels, particularly during early childhood and primary years, technical and vocational training, also in emergency and crisis situations, and with special attention to women and girls; and including through training and professional development for teachers, and the use of digital technologies to improve education teaching and learning; (p) Supporting actions of capacity building, learning mobility between the Union and partner countries or between partner countries themselves, as well as of cooperation and policy dialogue with institutions, organisations, local implementing bodies and authorities, from those countries; (q) Promoting cooperation in the areas of science, technology and research in particular addressing poverty related and societal changes, open data, big data, artificial intelligence and innovation, while preventing the phenomenon of brain drain; (r) Stepping up coordination amongst all relevant actors at all levels to help the transition from a natural or man-made emergency situation to the development phase; ensuring joined-up planning and programming of cooperation interventions, that are coherent with humanitarian aid, and, where relevant, peacebuilding actions, on the basis of joint analysis; (s) Supporting freedom of thought, conscience and religion or belief, including by means of measures to eliminate all forms of hatred, intolerance and discrimination based on religion or belief and by fostering tolerance and respect for religious and cultural diversity within and among societies; (t) Promoting intercultural dialogue and cultural diversity in all its forms, and preserve and promote cultural heritage, and unlocking the potential of creative industries for sustainable, social and economic development; (u) Supporting actions, and promoting cooperation, in the area of sport to contribute to the empowerment of women, young people, individuals and communities as well as to the health, education and social inclusion objectives of the 2030 Agenda; (v) Promoting the dignity and resilience of long-term forcibly displaced persons and their inclusion in the economic and social life of host countries and host communities, including at local level. 3. Migration, forced displacement and mobility (a) Strengthening bilateral, regional and international partnerships on migration, forced displacement and mobility based on an integrated and balanced approach, covering all aspects of migration including assistance in implementing Union bilateral or regional agreements, dialogues and arrangements, including those on return and readmission, legal pathways and mobility partnerships, in full respect of international law and human rights obligations; (b) Supporting sustainable reintegration of returning migrants and their families, as well as safe and dignified returns amongst partner countries in full respect of humanitarian and human rights obligations under international and Union law; (c) Addressing and mitigating root causes of irregular migration and forced displacement; (d) Tackling irregular migration and forced displacement; reducing the vulnerabilities in the context of migration including those caused by human trafficking and smuggling, as well as including supporting measures to protect victims of exploitation and abuse; and stepping up cooperation on integrated border management in line with international and Union law, human rights law, humanitarian law and data protection standards; (e) Strengthening scientific, technical, human and institutional capacity for the management of migration, including human rights trainings, support partner countries\u2019 reception, processing, asylum and return procedures; strengthening cross-border cooperation on exchange of information in compliance with data protection standards and obligations related to the right to privacy under international human rights law; and supporting the collection and use of accurate and disaggregated data as a basis for evidence-based policies in order to facilitate orderly, safe, regular and responsible migration and mobility; (f) Supporting effective and human rights based migration policies, at all levels, including protection programmes; (g) Promoting conditions for facilitating, as appropriate, legal migration and well-managed mobility, while respecting competences of the Member States, and people-to-people contacts, including in education, research and innovation, cultural exchange and intercultural dialogue, including by providing accurate and timely information, maximising the development impact of regular migration; (h) Improving a common understanding of the migration\u2013development nexus, recognising that orderly, safe, regular and responsible migration and mobility, peace, good governance, stability, inclusive growth and sustainable development are strongly interlinked, and pursuing synergies within these various dimensions; (i) Ensuring the protection, the respect and fulfilment of the human rights of all migrants, refugees, forcibly displaced persons and internally displaced persons, including those displaced due to climate change, paying special attention to vulnerable groups; (j) Supporting development oriented solutions for forcibly displaced persons, internally displaced persons and their host communities, including through socio-economic inclusion with access to labour market, decent jobs, education and services, to promote the dignity, resilience and self-reliance of displaced persons; (k) Supporting diaspora engagement in countries of origin to contribute to sustainable development, including through the involvement of local authorities and civil society organisations, taking into account their potential for investments, supporting their solidarity and entrepreneurial initiatives; (l) Promoting faster, cheaper and safer remittance transfers in both source and recipient countries, thus harnessing their potential for development. Cooperation in this area will be managed in coherence with migration-relevant Union regulations, in full respect of the principle of policy coherence for development. PLANET 4. Environment and climate change (a) Strengthening scientific, technical, human and institutional capacity for climate and environmental management, mainstreaming and monitoring; strengthening regional, national and local climate and environmental governance, and facilitating access to public and private sources for disaster risk reduction, ecosystems and biodiversity conservation and climate finance, as well as insurance; (b) Supporting adaptation to climate change, with special emphasis on particularly vulnerable States and populations; contributing to partners\u2019 efforts to pursue their commitments on climate change, ecosystems and biodiversity conservation, including at local level, in line with the Paris Agreement and the Sendai Framework for Disaster Risk Reduction. Those efforts include the implementation of the NDCs and mitigation and adaptation plans of action including synergies between adaptation and mitigation, through global initiatives such as the NDC Partnership, as well as their commitments under other multilateral environmental agreements, such as the UN Convention on Biological Diversity and the UN Convention to Combat Desertification; (c) Developing and/or strengthening sustainable green and blue growth and circular economy in all economic sectors; (d) Promoting access to sustainable energy in developing countries; strengthening sustainable renewable energy cooperation, in full compliance with highest international standards including for the assessment of both national and transboundary safety and environmental impacts. Promoting and increasing cooperation on energy efficiency and the production and use of renewable energy sources; promoting access to reliable, secure, affordable, clean and sustainable energy services; supporting, in particular small-scale, mini-grid and off-grid solutions of high environmental and developmental value, and local and decentralized solutions that ensure energy access for people living in poverty and in remote areas; (e) Building capacity to mainstream environmental sustainability and climate change objectives, and pursuing green growth into national and local development strategies including supporting sustainability criteria in public procurement; (f) Promoting the phasing-out of environmentally harmful fossil fuel subsidies, stable and transparent energy markets and the deployment of smart grids and the use of digital technologies for sustainable energy management; (g) Promoting corporate social responsibility, due diligence in supply chains, and the consistent application of the \u2018precautionary approach\u2019 and the \u2018polluter pays\u2019 principles; (h) Promoting environmentally sustainable agriculture practices, including agroecology and biodiversity as well as to enhance mitigation and adaptation to climate change and promote environmental and social resilience and healthy ecosystems; (i) Improving local, national, regional and continental multi-modal transport networks and services to strengthen further opportunities for sustainable climate-resilient economic development and job creation, in view of low-emission, climate resilient development. Strengthening transport facilitation and liberalisation, improve sustainability, road safety and resilience of transport domains; (j) Strengthening the involvement of local authorities and communities and indigenous peoples in climate change responses, the fight against biodiversity loss and wildlife crime, conservation of ecosystems and the conflict sensitive governance of natural resources, including through the improvement of land tenure and water resources management. Promoting sustainable urban development and resilience in urban areas; strengthening and promoting participation and access to complaint and redress mechanisms at national and local level, especially for indigenous peoples as set out in the UNDRIP; (k) Promoting education for sustainable development to empower people to transform society and build a sustainable future; (l) Promoting the conservation, sustainable and conflict sensitive management and use, and restoration of natural resources, healthy terrestrial and non-terrestrial ecosystems and halting biodiversity loss, protecting wildlife, including combating poaching and illegal wildlife trafficking; strengthening consultation and promoting regional transboundary cooperation and ensuring free, prior informed consent and effective participation of indigenous peoples as set out in the UNDRIP; (m) Promoting integrated, sustainable, participatory and conflict sensitive management of water resources and transboundary water cooperation in accordance with international law, involving where relevant local authorities; (n) Promoting conservation and enhancement of carbon stocks through sustainable management of land use, land-use change, and forestry and combating environmental degradation, desertification and land and forest degradation and drought, involving where relevant local authorities; (o) Promoting forestation and protection of natural forests; reducing deforestation and promoting forest law enforcement, governance and trade, and combating illegal logging, trade of illegal timber and wood products. Supporting better governance and capacity building for the sustainable management of natural resources, including through subnational governments; supporting the negotiation and the implementation of voluntary partnership agreements; (p) Supporting ocean governance, including the protection, restoration and preservation of coastal and marine areas in all its forms, including ecosystems, the fight against marine litter, the fight against illegal, unreported and unregulated fishing and the protection of maritime biodiversity in accordance with the UN Convention on the Law of the Sea; (q) Strengthening regional disaster risk reduction, preparedness and resilience, including through investment, and through promoting a community-based and people-centred approach, in synergy with climate change adaptation policies and actions; (r) Promoting resource efficiency and sustainable consumption and production, in particular throughout the entire supply chain, towards the transition to a circular economy, including by curbing the use of natural resources financing conflicts, and by supporting compliance by stakeholders with relevant initiatives; tackling pollution, reducing air pollutants, in particular black carbon and promoting a sound management of chemicals and waste; (s) Supporting efforts to improve sustainable economic diversification, competitiveness, local value-added in supply chains and sustainable trade, private sector development with a particular focus on low-emission climate-resilient green growth, SMEs and cooperatives, taking advantage of the benefits of existing trade agreements with the Union for sustainable development; (t) Promoting the achievement of commitments regarding biodiversity conservation in international agreements; (u) Increasing the integration and mainstreaming of climate change and environmental objectives through support for methodological and research work; (v) Addressing global and trans-regional effects of climate change having a potentially destabilising impact on development, peace and security. PROSPERITY 5. Inclusive and sustainable economic growth and decent employment (a) Supporting entrepreneurship, including through microfinance, decent employment and employability through the development of skills and competences, education and vocational training, the improvement of the full application of international labour standards and including social dialogue and the fight against child labour, working conditions in a healthy environment, gender equality, living wages and the creation of opportunities particularly for the youth as well as women; (b) Supporting national and local development paths that maximise positive social outcomes and impacts, reduce the risk of exclusion and marginalisation of certain groups, promoting fair, efficient and sustainable taxation and redistributive public policies, and the setting-up and strengthening of sustainable social protection systems and social insurance schemes; supporting efforts at national and international levels to combat tax evasion and tax havens; (c) Improving the business environment and investment climate at local and national levels, creating an enabling regulatory environment for economic development and supporting companies, in particular SMEs, including start-ups, as well as cooperatives, social enterprises and women entrepreneurs in expanding their business and creating jobs, supporting the development of a solidarity economy and enhancing responsible business conduct and private sector accountability; (d) Promoting corporate accountability and redress mechanisms for violations of human rights related to private sector activities; supporting efforts at local, regional and global level to ensure corporate compliance with human rights standards and regulatory developments, including on mandatory due diligence, and with international commitments on business and human rights; (e) Strengthening social and environmental sustainability, inclusiveness, corporate social responsibility and responsible business conduct, and respecting and promoting human rights standards and principles throughout the entire value chains, supporting shared value addition and fair trading conditions; (f) Increasing relevance, effectiveness and sustainability of public spending, including through promoting sustainable public procurement; and promoting more strategic use of public finance, including through blending instruments to crowd in additional public and private investment; (g) Boosting the potential of cities as hubs for sustainable and inclusive growth and innovation; (h) Promoting internal economic, social and territorial cohesion, forging stronger links between urban and rural areas and facilitating the development of both creative industries and a sustainable tourism sector as a leverage for sustainable development; (i) Boosting and diversifying sustainable and inclusive agricultural and food value chains, promoting food security and economic diversification, value addition, regional integration, competitiveness and fair trade, and strengthening sustainable, low-emission and climate-change-resilient innovations; (j) Focusing on ecologically efficient agricultural intensification for smallholder farmers, and in particular women, by providing support for effective and sustainable national policies, strategies and legal frameworks, and for equitable and sustainable access to, and management of resources, including land and land right, water, other agricultural inputs, and (micro) credit; (k) Supporting greater participation of civil society, including at regional level, in particular farmer organisations in policy making and research programmes and increasing their involvement in the implementation and evaluation of government programmes; (l) Supporting and promoting sustainable fisheries management and sustainable aquaculture; (m) Fostering universal access to affordable, reliable and sustainable energy, promoting a low-emission, climate-resilient, resource-efficient and circular economy in line with the objectives of the Paris Agreement and the 2030 Agenda; (n) Promoting smart, sustainable, inclusive, safe mobility, as well as improving transport connectivity with the Union; (o) Promoting accessible, affordable, inclusive, reliable and secure digital connectivity and strengthening the digital economy; promoting digital literacy and skills; fostering digital entrepreneurship and job creation; promoting the use of digital technologies as an enabler for sustainable development; addressing cybersecurity, data privacy and other regulatory issues linked to digitalisation; (p) Developing and strengthening markets and sectors in a way that would bolster inclusive, sustainable and climate-resilient growth and fair trade, as well as reduce the socio-economic marginalisation of vulnerable groups; (q) Supporting the regional integration agenda and optimal trade policies in support of inclusive and sustainable development, strengthening countries\u2019 capacity to trade, and supporting the consolidation and implementation of trade agreements between the Union and its partners, including holistic and asymmetrical agreements with developing country partners, in line with human rights standards; promoting and strengthening multilateralism, sustainable economic cooperation, as well as measures aimed at promoting and strengthening the rules of the World Trade Organization; (r) Promoting cooperation in the areas of science, technology and research, digitalisation, open data, big data and artificial intelligence and innovation, including the development of science diplomacy; (s) Promoting intercultural dialogue and cultural diversity in all its forms, developing local crafts as well as contemporary arts and cultural expressions, preserving and promoting cultural heritage, unlocking the potential of creative industries for sustainable, social and economic development, and guaranteeing as well as strengthening rights of indigenous peoples as set out in the UNDRIP, and local communities and their effective participation and empowerment; (t) Empowering women to take up a greater economic role and in decision-making, including at local level; (u) Improving access to decent work for all in a healthy environment, and creating more inclusive and well-functioning labour markets and employment policies directed towards decent work, respect for human rights and labour rights, including living wages for all, especially women and youth; (v) Promoting fair, sustainable, undistorted, conflict-sensitive and non-corrupted access to extractive sectors, while respecting human rights; increasing transparency, due diligence and investor responsibility while promoting private sector accountability; applying measures to accompany Regulation (EU) 2017/821 of the European Parliament and of the Council (1). PEACE 6. Peace, stability and conflict prevention (a) Contributing to peace, the prevention of conflict and therefore to stability through building resilience of states, sub-national governments, societies, communities and individuals to political, economic, environmental, food, demographic, security and societal pressures and shocks, including by countering hybrid threats and supporting resilience assessments designed to identify the local capacities within societies that allow them to withstand, adapt to and quickly recover from these pressures and shocks; addressing political and economic exclusion and other long-term structural and root causes of conflict, insecurity and instability; (b) Promoting a culture of non-violence, including by supporting formal, informal and non-formal peace education; (c) Supporting conflict prevention, early warning and peacebuilding through mediation and dialogue, crisis management, and stabilisation and post-conflict reconstruction, including an enhanced role for women at all of these stages; promoting, facilitating and building capacity in confidence building, mediation, dialogue and reconciliation, good neighbourly relations and other measures contributing to the prevention and settlement of conflicts, with particular regard to emerging inter-community tensions as well as conciliation measures between segments of societies and protracted conflicts and crises; (d) Supporting rehabilitation and reintegration of victims of armed conflicts, supporting disarmament, demobilisation and reintegration of former combatants and their families into society and addressing the social effects of restructuring the armed forces, including the specific needs of women; (e) Enhancing women\u2019s and youth systematic participation, including in decision-making and implementation, in peace negotiations, reconciliation processes, conflict prevention and peacebuilding and their inclusion, meaningful civil and political participation and social recognition in line with UNSCR 1325 (2000), in particular in fragile, conflict and post-conflict situations and countries, also in order to address the disproportionate impact of violent conflict on them and better consider their special needs during conflict; (f) Preventing all forms of sexual and gender-based violence, including the use of sexual violence as a weapon of war; (g) Supporting gender- and conflict-sensitive security sector reform that guarantees the respect, promotion and fulfilment of the Union fundamental values and good governance principles and gradually provides individuals, civil society and the state with more effective, democratic and accountable security capacities and instruments for sustainable development and peace; (h) Supporting capacity-building of military actors in support of development and security for development, in accordance with Article 9; (i) Supporting regional and international disarmament initiatives and arms export control regimes and mechanisms; (j) Supporting local, national, regional and international initiatives contributing to security, stability and peace, including disarmament initiatives and arms export control regimes and mechanisms, demining and mine-action as well as linking those different initiatives, and addressing the socio-economic impact on the civilian population, including the needs of women, of antipersonnel landmines, unexploded ordnance or explosive remnants of war; (k) Preventing and countering radicalisation leading to violent extremism and terrorism, as well as protecting individuals from such threats, including by means of context-specific, conflict- and gender-sensitive actions; (l) Supporting ad hoc, local, national, regional and international tribunals, truth and reconciliation commissions and mechanisms; (m) Fighting against any form of violence, corruption and organised crime and money laundering; (n) Promoting transboundary cooperation regarding the sustainable, conflict-sensitive and participatory management of shared natural resources in accordance with international and Union law and respecting and promoting human rights of affected individuals and groups including indigenous peoples as set out in the UNDRIP and local communities; (o) Cooperating with third countries in the peaceful use of nuclear energy in the areas of health, agriculture and food safety, ensuring full compliance with the highest international standards; as well as supporting social actions addressing the consequences on the population in countries exposed to any radiological accident and aiming at improving their living conditions; promoting knowledge-management, training and education in nuclear-related fields. Where applicable, these activities shall be coherent with those of the European Instrument for International Nuclear Safety Cooperation; (p) Enhancing maritime security and safety to allow for safe, secure, clean and sustainably managed oceans; (q) Supporting capacity-building in cyber security, resilient digital networks, data protection and privacy, in line with human rights standards and principles. PARTNERSHIP 7. Partnership (a) Enhancing country ownership, partnership and constructive dialogue, including with civil society, in order to contribute to greater effectiveness of development cooperation in all its dimensions (giving special consideration for the specific challenges of LDCs and countries affected by conflict and fragility, as well as specific transitional challenges of middle income countries and more advanced developing countries), implementing a rights-based approach to development cooperation, encompassing all human rights and ensuring that no one is left behind; (b) Deepening political, economic, social, environmental and cultural dialogue between the Union and third countries and regional and international organisations, and supporting implementation of bilateral and international commitments; (c) Fostering greater inclusiveness and collaboration of all actors in the implementation of development cooperation and external action policies, seeking to share lessons learned, maximise capacities, added value, excellence and experience, thus reinforcing common goals, values and interests and the ambition of working better together; (d) Encouraging good neighbourly relations, regional integration, enhanced connectivity, cooperation and inclusive and constructive dialogue, including, inter alia, enhanced regional cooperation in the framework of the EU Strategy for connecting Europe and Asia, the EU Strategy on Central Asia, the EU-Africa partnership, the Black Sea regional cooperation, the Arctic cooperation and the Northern Dimension; (e) Supporting and increasing cooperation by partner countries and regions with neighbouring Union outermost regions and with overseas countries and territories; (f) Promoting an enabling environment for civil society organisations and foundations, enhancing their meaningful, continuous and structured participation in domestic and international policies and their capacity to perform their roles as independent development and governance actors; and strengthening multi-stakeholder approaches and new ways of partnering with civil society actors, including women\u2019s rights organisations; supporting democracy and expanding civic space; promoting a substantive and structured dialogue with the Union and the effective use and implementation of country roadmaps for Union engagement with civil society; (g) Engaging with local authorities and supporting their role as policy and decision-makers to boost local development, including the business environment, and improved governance, as well as development and governance actors; promoting an enabling regulatory and institutional framework allowing local authorities to exercise their mandate, enhancing their meaningful, continuous and structured participation in domestic and international policies; and strengthening multi-stakeholders and multilevel governance approaches and new ways of partnering with local authorities; (h) Engaging more effectively with the population, including human rights defenders, in third countries, including by making full use of economic, cultural and public diplomacy; (i) Engaging industrialised and more advanced developing countries on the implementation of the 2030 Agenda, global public goods and challenges, including in the area of South-South and triangular cooperation; (j) Encouraging regional integration and cooperation, in a result-oriented way through support for regional integration and dialogue; (k) Building partnerships with the private sector for creating jobs and enhancing livelihoods in partner countries. (1) Regulation (EU) 2017/821 of the European Parliament and of the Council of 17 May 2017 laying down supply chain due diligence obligations for Union importers of tin, tantalum and tungsten, their ores, and gold originating from conflict-affected and high-risk areas (OJ L 130, 19.5.2017, p. 1). ANNEX III AREAS OF INTERVENTION FOR THEMATIC PROGRAMMES 1. AREAS OF INTERVENTION FOR HUMAN RIGHTS AND DEMOCRACY The Union shall contribute to advancing the fundamental values of democracy, the rule of law, the universality, indivisibility and interdependence of human rights, respect for human dignity, the principles of non-discrimination, equality and solidarity, and respect for the principles of the Charter of the UN and international human rights law, mainly in the following areas: 1. Upholding human rights and fundamental freedoms for all, contributing to forging societies in which participation, tolerance, non-discrimination, human dignity, equality, social justice, international justice and accountability prevail. This includes two major axes: (a) Monitoring, promoting and strengthening respect for and observance of all human rights, be they civil and political, as well as economic, social and cultural rights. This shall include, inter alia, actions: to abolish the death penalty, promote the fight against enforced disappearances, to prevent and eliminate torture, ill-treatment and other cruel, inhumane and degrading punishment or treatment, to promote freedom of expression, assembly and association, freedom of thought, conscience and religion or belief; to promote and protect gender equality and women and girls\u2019 empowerment in all spheres of life, including in education, health and those areas and rights referred to in Article 8(4), work-life balance, political decision-making and supporting measures to eliminate all forms of violence against women and girls; to promote and protect, the rights of the child, women, youth, LGBTI persons, including measures to decriminalise homosexuality, persons belonging to national or ethnic, religious and linguistic minorities, indigenous peoples as set out in the UNDRIP, and persons with disabilities, and to fight racism, xenophobia and discrimination based on any grounds. Within the specified scope, Union assistance shall particularly address the most context-sensitive human rights issues, respond to the shrinking space for civil society active in the promotion and protection of human rights, as well as counter other emerging and complex challenges; (b) Protecting and empowering human rights defenders worldwide, in particular in countries where disrespect for human rights and fundamental freedoms is particularly pronounced and systematic, including where restrictive measures have been introduced to limit their actions and their action is critical to reinforce the institutional and legal human rights framework. Emergency, medium-term and long-term assistance as well as sustainable measures shall be given to human rights defenders and civil society, in particular local human rights defenders and civil society, including through a dedicated mechanism for the protection of human rights defenders, to carry out their work unhindered. 2. Developing, supporting, consolidating and protecting democracy, addressing all aspects of democratic governance, including reinforcing political pluralism, representation, and accountability, reinforcing democracy at all levels, enhancing citizen and civil society participation, supporting credible, inclusive and transparent electoral processes as well as supporting citizen capacity in monitoring democratic and electoral systems, through the support to domestic citizen election observation organisations and their regional networks. Democracy shall be strengthened by upholding the main pillars of democratic systems, democratic norms and principles, free, independent and pluralistic media, both online and offline, internet freedom, the fight against censorship, accountable and inclusive institutions, including parliaments and political parties, and the fight against corruption. Union assistance shall support civil society action in strengthening the rule of law, promoting the independence of the judiciary and of the legislature, supporting and evaluating legal and institutional reforms and their implementation, monitoring democratic and electoral systems and promoting access to affordable justice for all, including to effective and accessible complaint and redress mechanisms at national and local level. Election observation shall play a full part in the wider support for the democratic processes. Within this context, EU election observation shall continue to be a major component of the programme as well as the follow-up to recommendations of EU election observation missions. Areas of intervention 1 and 2 shall contribute to strengthening cooperation and partnership with civil society working on human rights and democracy, including in sensitive situations, and fostering new regional and cross-regional synergies, by means of knowledge sharing, including best practices sharing, and networking building among local civil society and between civil society and other relevant human rights bodies and mechanisms to enhance their capacities, including their resilience, and develop a compelling narrative on human rights and democracy with a multiplying effect. 3. Promoting effective multilateralism and strategic partnership, contributing to reinforcing capacities of international, regional and national instruments and mechanisms in promoting and protecting human rights, democracy and the rule of law. Strategic Partnerships shall be boosted, with a particular attention to the Office of the High Commissioner for Human Rights, the International Criminal Court and other relevant international, regional and national human rights mechanisms. Furthermore, the programme shall promote education and research on human rights and democracy, including through the Global Campus of Human Rights. 2. AREAS OF INTERVENTION FOR CIVIL SOCIETY ORGANISATIONS 1. Inclusive, participatory, empowered and independent civil society and democratic space in partner countries (a) Creating an enabling and accessible environment for citizen participation and civil society action, including through foundations by supporting active civil society participation in policy dialogues and the consolidation of dialogue platforms for non-state actors; (b) Supporting and building the capacity of civil society organisations, and foundations, to act as both actors of development and good governance in their own right; (c) Capacity building for civil society organisations for their support of vulnerable and marginalised groups by providing basic social services such as health - including nutrition, education, social protection, and access to safe water, sanitation and hygiene; (d) Supporting and empowering women\u2019s organisations and other relevant organisations working on gender equality as well as women human rights defenders to have the opportunity to work and be protected against threats and violence; (e) Increasing the capacity of civil society networks, platforms and alliances in partner countries; (f) Enabling civil society to carry out their work, through, inter alia, capacity building, coordination and institutional strengthening for civil society organisations, taking into account the importance of enabling space for their actions and access to funding, including to engage within their organisations and between different types of stakeholders. Fostering dialogue between civil society organisations and governments on public policy. 2. Inclusive and open dialogue with and between civil society actors (a) Promoting inclusive multi-stakeholder dialogue fora, including interaction and coordination between citizens, civil society, local authorities, Member States, partner countries, the private sector and other key development stakeholders; (b) Enabling cooperation and exchange of knowledge and experience between and with civil society actors domestically and internationally; (c) Fostering cooperation and partnerships of civil society organisations with international intergovernmental organisations, including capacity building aimed at promoting and monitoring the implementation of international and regional instruments, including those concerning human rights, justice, the rule of law and democracy; (d) Ensuring a substantive and continued structured dialogue and partnerships with the Union. 3. Awareness, understanding, knowledge and engagement of European citizens regarding development issues (a) Empowering people to increase their engagement on development issues and the SDGs, including through raising public awareness, promoting formal, informal and non-formal education for development, especially among youth, and promoting knowledge sharing between the relevant actors, focusing on the Union Member States, candidate and potential candidate countries; (b) Mobilising public support in the Union, candidate countries and potential candidates for sustainable and inclusive development strategies, including poverty reduction, in partner countries. 3. AREAS OF INTERVENTION FOR PEACE, STABILITY AND CONFLICT PREVENTION 1. Assistance for conflict prevention, peacebuilding and crisis preparedness The Union shall provide technical and financial assistance covering support for conflict-sensitive measures aimed at building and strengthening the capacity of the partners to analyse risks, prevent conflict, build peace and address pre- and post-crisis needs in close coordination with the UN and other international, regional and sub-regional organisations, and State, civil society and local authorities actors, in relation to their efforts mainly in the following areas, including specific attention to gender equality, ensuring the effective participation and empowerment of women and youth: (a) early warning and conflict-sensitive risk analysis in policy-making and the implementation of policy; (b) facilitation and building capacity in confidence-building, mediation, dialogue and reconciliation measures, including at community level, with particular regard to emerging inter-community tensions, especially with a view to the prevention of genocide and crimes against humanity; (c) conflict prevention; (d) strengthening capacities for participation and deployment in civilian stabilisation, peacekeeping and peacebuilding missions; (e) improving post-conflict recovery as well as post-disaster recovery, with relevance to the political and security situation; (f) supporting stabilisation, safety of individuals and human security restoration measures, including mine action, demining and transitional justice in line with relevant multilateral agreements; (g) supporting peacebuilding and state-building actions, involving, where appropriate, civil society organisations, states and international organisations, as well as strengthening state-society relations; (h) contributing to the further development of structural dialogue on peacebuilding issues at various levels, between civil society and partner countries, and with the Union; (i) crisis response and preparedness; (j) curbing the use of natural resources to finance conflicts, and supporting compliance by stakeholders with initiatives such as the Kimberley Process Certification Scheme, and including legal acts such as Regulation (EU) 2017/821, especially as regards the implementation of efficient domestic controls over the production of, and trade in, natural resources; (k) capacity building of military actors in support of development and security for development in accordance with Article 9; (l) supporting actions promoting gender equality and women\u2019s empowerment, in particular through implementation of UNSCRs 1325 (2000) and 2250 (2015) as well as participation and representation of women and youth in formal and informal peace processes; (m) promoting a culture of non-violence, including by supporting formal, informal and non-formal peace education; (n) supporting actions strengthening the resilience of states, societies, communities and individuals, including resilience assessments designed to identify the endogenous capacities within societies that allow them to withstand, adapt to and quickly recover from pressures and shocks; (o) supporting international criminal tribunals and ad hoc national tribunals, truth and reconciliation commissions, transitional justice and other mechanisms for the legal settlement of human rights claims and the assertion and adjudication of property rights; (p) supporting measures to combat the illicit use of, and access to, firearms, small arms and light weapons; (q) supporting know-how transfer, the exchange of information and best practices, risk or threat assessment, research and analysis, early warning systems, training and service delivery. 2. Assistance in addressing global and trans-regional threats and emerging threats The Union shall provide technical and financial assistance to support partners\u2019 efforts and Union actions addressing global and trans-regional threats and emerging threats mainly in the following areas: (a) threats to law and order, and to the security and safety of individuals including terrorism, radicalisation leading to violent extremism, organised crime, cyber-crime, hybrid threats, illicit trafficking, trade and transit; in particular strengthening the capacity of law enforcement and judicial and civil authorities involved in the fight against terrorism, organised crime, including cyber-crime; (b) threats to public spaces, critical infrastructure, including international transport, including passenger and freight traffic, energy operations and energy distribution, cybersecurity; (c) threats to public health, including sudden epidemics with a potential trans-national impact; (d) threats to environmental stability, maritime security threats, threats having a potentially destabilising impact on peace and security, deriving from climate change impacts; (e) mitigation against risks, whether of an intentional, accidental or natural origin, related to chemical, biological, radiological and nuclear materials or agents and risks to related installations or sites, or explosive remnants of wars and conflicts, in particular in the following areas: (i) supporting and promoting civilian research activities as an alternative to defence-related research; (ii) enhancing safety practices related to civilian facilities where sensitive chemical, biological, radiological and nuclear materials or agents are stored or are handled in the context of civilian research programmes; (iii) supporting, within the framework of Union cooperation policies and their objectives, the establishment of civil infrastructure and relevant civilian studies necessary for the dismantlement, remediation or conversion of weapons-related facilities and sites where these are declared to be no longer part of a defence programme; (iv) strengthening the capacity of the competent civilian authorities involved in the development and enforcement of effective control of illicit trafficking in chemical, biological, radiological and nuclear materials or agents (including the equipment for their production or delivery); (v) developing the legal framework and institutional capacities for the establishment and enforcement of effective export controls, in particular on dual-use goods, including regional cooperation measures and as regards the implementation of the provisions of the Arms Trade Treaty and the promotion of adherence to it; (vi) developing effective civilian disaster-preparedness, emergency planning and response, and capabilities for clean-up measures. Where applicable, these activities shall be coherent with those of the European Instrument for International Nuclear Safety Cooperation; (f) capacity building of military actors in support of development and security for development, in accordance with Article 9. Priority shall be given to trans-regional cooperation involving two or more third countries which have demonstrated a clear political will to address the aforementioned threats. The measures shall place particular emphasis on good governance and shall be in accordance with international law. Cooperation in the fight against terrorism may also be conducted with individual countries, regions or international, regional and sub-regional organisations. With regard to assistance to authorities involved in the fight against terrorism, priority shall be given to supporting measures concerning the development and strengthening of counter-terrorism laws, the implementation and practice of financial law, of customs law and of immigration law, the development of law-enforcement procedures which are aligned with the highest international standards and which comply with international law, the strengthening of democratic control and institutional oversight mechanisms, and the prevention of violent radicalism. With regard to assistance relating to the problem of drugs, due attention shall be given to international cooperation aimed at promoting best practices relating to the reduction of demand, production and harm. 4. AREAS OF INTERVENTION FOR GLOBAL CHALLENGES A. PEOPLE 1. Health (a) Developing crucial elements of an effective and comprehensive health system, including communicable diseases, that are best addressed at a global level to secure equitable, affordable, inclusive and universal access to health services, including those referred to in Article 8(4); (b) Promoting, providing and expanding essential services and psychological support services for victims of violence, in particular women and children rape victims; (c) Reinforcing global initiatives that are key enablers of universal health coverage through global leadership on a \u2018health in all policies\u2019 approach with a continuum of care, including health promotion, from prevention to post-treatment; (d) Addressing global health security and antimicrobial resistance through communicable diseases research, including on poverty-related and neglected and vaccine-preventable diseases and control, combating fake medicines, translating knowledge into safe, accessible and affordable products (including generic medicines) and diagnostics and related health technologies, and policies that tackle the changing disease burden (non-communicable diseases, all forms of malnutrition and environmental risk factors), and shape global markets to improve access to affordable essential health commodities and health services, including those referred to in Article 8(4); (e) Supporting global initiatives for the development of safe, efficient and affordable vaccines. 2. Education (a) Promoting the achievement of internationally agreed goals in education through joint global efforts for accessible, inclusive and equitable quality education and training, including of teachers, at all levels, for all ages, also in emergency and crisis situations and with a particular priority on strengthening free education systems; (b) Strengthening knowledge, skills and values through partnerships and alliances, including support for education data and analysis, research and innovation, knowledge exchange, and education networks, for active citizenship and productive, educated, democratic, inclusive and resilient societies; (c) Supporting global action on reducing all dimensions of discrimination and inequalities, such as the gaps between girls/women and boys/men, and between different groups in society, to ensure that everyone has equal opportunity to take part in economic, political, social and cultural life; (d) Supporting inclusive and quality education in fragile environments; (e) Supporting actions and promoting cooperation in the area of sport to contribute to the empowerment of women and of young people, individuals and communities. 3. Gender equality and women\u2019s and girls\u2019 empowerment (a) Committing to advance gender equality and girls\u2019 and women\u2019s empowerment in all spheres; including support to establish a more enabling economic, political and social environment for the fulfilment of girls\u2019 and women\u2019s rights that will enable them to fully participate in society, have equal opportunities for leadership in social, economic, political and civil life and be a driver of development; (b) Leading and supporting global efforts, partnerships and alliances for the rights of women and girls, as set out in the UN Convention on the Elimination of All Forms of Discrimination against Women and the Optional Protocol thereto to eliminate all forms of discrimination against women and girls, including exclusion that women suffer in the different areas of their private and public lives such as the labour market and access to social and health services; (c) Leading and supporting global efforts, partnerships and alliances for the rights of women to eliminate all forms of violence, harmful practices against women and girls, including physical, psychological, sexual and gender-based violence, female genital mutilation, as well as forced, early and child marriage and economic, political and other types of violence and discrimination, including in crisis situations as well as the exclusion that women suffer in the different areas of their private and public lives; (d) Addressing root causes of gender inequalities as a means of supporting conflict prevention and peacebuilding; promoting the empowerment of women, including in their roles as development actors and peacebuilders; (e) Promoting the protection and fulfilment of all women\u2019s and girls\u2019 rights, including those referred to in Article 8(4); (f) Promoting the protection and fulfilment of rights of women and girls, including economic, political, labour and social rights and those referred to in Article 8(4). 4. Children and Youth (a) Promoting universal access to all social and health services for children and youth, including the most marginalised, with a focus on health, nutrition, education, social protection, and early childhood development, including through dedicated youth friendly services; (b) Promoting new initiatives to build stronger child protection systems in third countries, ensuring that children get the best start in life and are protected in all areas from violence, abuses and neglect, including by promoting the transition from institutional to community-based care for children; (c) Promoting children\u2019s and young people\u2019s empowerment by opening spaces for their active and meaningful participation in matters that concern them, in particular to political life and to peace process and mediation efforts, by supporting initiatives of inter-cultural dialogue among youth organisations and by preventing marginalisation and exclusion; (d) Stepping up assistance to youth to support them in acquiring relevant skills and in accessing decent and quality jobs through education, vocational and technical training, as well as digital technologies; (e) Promoting youth empowerment and responsible citizenship, by opening spaces for their active and meaningful participation in political life and in peace process and mediation efforts, by supporting initiatives of inter-cultural dialogue among youth organisations and by preventing marginalisation and exclusion; (f) Creating an enabling environment that provides new and innovating opportunities for youth civic engagement, youth entrepreneurship and youth employment. 5. Migration, forced displacement and mobility (a) Ensure continued Union leadership in shaping the global agenda on migration and forced displacement governance in all its dimensions, particularly to facilitate orderly, safe, regular and responsible migration, in line with human rights, and international refugee law and international humanitarian law; (b) Steering and supporting global and cross-regional policy dialogues, including on South-South migration, and exchange and cooperation on migration and forced displacement; (c) Supporting the implementation of international and Union commitments on migration and forced displacement, including at UN level; (d) Improving the global evidence base, including on the migration/development nexus, and initiate actions of pilot character aiming at developing innovative operational approaches in the area of migration and forced displacement; (e) Boosting strategic partnerships with relevant international organisations to support international cooperation and migration governance according to international human rights law and international refugee law. Cooperation in this area will be managed in coherence with migration-relevant Union regulations, in full respect of the principle of policy coherence for development. 6. Decent work, social protection, inequality and inclusion (a) Shaping the global agenda and support initiatives on the integration of a strong pillar on equity and social justice in accordance to European values; (b) Contributing to the global agenda on decent work for all in a healthy environment, on the basis of the core ILO labour standards, including on social dialogue, living wages and the fight against child labour, corporate social responsibility, in particular in making global value chains sustainable and responsible, and enhancing knowledge on effective gender-responsive employment policies that respond to labour market needs and promote socio-economic inclusion, including vocational education and training and life-long learning; (c) supporting global initiatives on business and human rights, including corporate accountability for rights violations and access to remedies; (d) Supporting global initiatives on universal social protection that follow the principles of efficiency, sustainability and equity; including support to address inequality in order to enhance gender equality and social cohesion, in particular with the setting-up and strengthening of sustainable social protection systems, social insurance schemes; (e) Continuing global research and development through social innovation that enhances social inclusion and addresses the rights and specific needs of the most vulnerable sections of society; (f) Promoting and supporting efforts to make social, political and economic life more inclusive and to address socio-economic drivers of conflict. 7. Culture (a) Promoting initiatives for cultural diversity, intercultural and interreligious dialogue for peaceful inter-community relations; (b) Supporting culture as an engine for sustainable social and economic development and reinforcing cooperation on, and preservation of, cultural heritage; (c) Developing local crafts, as a means to preserve local cultural heritage and foster sustainable development; (d) Reinforcing cooperation on safeguarding, conservation and enhancement of cultural heritage, including the preservation of particularly vulnerable cultural heritage, in particular from minority and isolated communities and indigenous peoples as set out in the UNDRIP; (e) Supporting agreements for the return of cultural property to their countries of origin; (f) Supporting cultural cooperation, including through exchanges, partnerships and other initiatives and the recognition of the professionalism of authors, artists and cultural and creative operators; (g) Supporting cooperation and partnerships among sport organisations. B. PLANET 1. Ensuring a healthy environment and tackling climate change (a) Strengthening global climate and environmental governance, the implementation of the Paris Agreement, the UN Convention on Biological Diversity, the UN Framework Convention on Climate Change and the UN Convention to Combat Desertification and other multilateral environmental agreements; (b) Contributing to the external projection of the Union\u2019s environment and climate change policies; (c) Integrating environment, ecosystems and biodiversity conservation, climate change, disaster risk reduction and preparedness objectives in policies, plans and investments including through improved knowledge and information; (d) Implementing international and Union initiatives to promote climate change adaptation and mitigation and climate-resilient low-emission development, including through the implementation of the NDCs and long-term low emission and climate-resilient strategies, promoting disaster risk reduction, address environmental degradation and halting biodiversity loss, promoting the conservation and sustainable use and management of terrestrial and marine ecosystems and renewable natural resources, including land, water, oceans, fisheries and forests, promoting forestation and protection of natural forest, addressing deforestation, desertification, land degradation, illegal logging and wildlife trafficking, tackling pollution, including marine litter, and ensuring a healthy environment, addressing climate and environmental issues, including displacement due to natural disasters, promoting resource efficiency, sustainable consumption and production, integrated water resource management and the sound management of chemicals and waste and supporting the transition to low emission, climate-resilient green and circular economies, as well as promoting corporate responsibility and a responsible business conduct; (e) Promoting environmentally sustainable agricultural practices, including agro-ecology, in order to protect ecosystems and biodiversity and enhance environmental and social resilience to climate change, with a particular focus on supporting smallholder farmers, workers and artisans; (f) Implementing international and Union initiatives to address biodiversity loss, promoting the conservation, sustainable use and management of terrestrial and marine ecosystems and associated biodiversity; (g) Promoting phase-out of environmentally harmful fossil fuel subsidies, encouraging adoption of cost-reflective tariffs by energy utilities, and exploring more cost-effective and climate-friendly alternatives for social protection. 2. Sustainable Energy (a) Supporting global efforts, commitments, partnerships and alliances, including sustainable energy transition; (b) Promoting energy security for partner countries and local communities, including diversification of sources and routes, considering price volatility issues, emission reduction potential, improving markets and fostering energy and, in particular, electricity interconnections and trade; (c) Encouraging partner governments to embrace energy sector policy and market reforms so to establish a conducive environment for inclusive growth and investments increasing access to energy services for all that are climate-friendly, affordable, modern, reliable and sustainable, with priority to renewable energy and energy efficiency; (d) Exploring, identifying, mainstreaming globally and supporting financially sustainable business models with scalability and replicability potential providing innovative and digital technologies through innovative research ensuring increased efficiency, in particular for decentralised approaches providing energy access through renewable energy including in areas where the local market capacity is limited. C. PROSPERITY 1. Sustainable and inclusive growth, decent jobs and private sector engagement (a) Promoting sustainable private investment through innovative financing mechanisms and risk-sharing; (b) Improving business environment and investment climate, developing a socially and ecologically responsible local private sector, supporting enhanced public-private dialogue, and building capacities, competitiveness and resilience of local SMEs and start-ups, as well as of cooperatives and social enterprises, and their integration into the local, regional and global economy; (c) Promoting financial inclusion by fostering access to and effective use of financial services, such as micro-credit and savings, micro-insurance and payment transfer, by SMEs and households, in particular disadvantaged and vulnerable groups; (d) Supporting the implementation of the Union trade policy and trade agreements, in line with sustainable development; strengthening partner countries\u2019 capacities to trade and improving access to partner country markets and boosting fair trade, responsible and accountable investment and business opportunities for companies from the Union while eliminating barriers to market access and investment, as well as aiming at easing access to climate-friendly technologies, while ensuring as much as possible added value sharing and human rights due diligence in supply chains, taking into account policy coherence for development; (e) Promoting an effective policy mix supportive of economic diversification, value addition, and regional integration and sustainable green and blue economy; (f) Fostering access to digital technologies, including promoting access to finance and financial inclusion, as well as e-commerce; (g) Promoting sustainable consumption and production and innovative technologies and practices for low-emission, resource efficient and circular economy; (h) Strengthening social and environmental sustainability, corporate social responsibility and responsible business conduct throughout the entire value chains; (i) Combating money laundering, corruption, illicit financial flows as well as tax evasion and avoidance. Promoting progressive taxation, anti-corruption measures and policies for redistributive public expenditures; (j) Promoting inclusive growth, including by promoting and supporting women\u2019s and youth\u2019s participation and by proactively identifying and addressing economic marginalisation of specific groups. 2. Food and nutrition security (a) Supporting and influencing international strategies, organisations, mechanisms and actors that roll-out major global policy issues and frameworks around sustainable food and nutrition security, reducing fragmentation in the global nutrition architecture and contributing to accountability on international commitments on food security, nutrition and sustainable agriculture; (b) Improving global public goods pursuing an end to hunger and malnutrition; ensuring equitable access to food including by helping to address the financing gap for nutrition, including through tools such as the Global Network on Food Crises to enhance the capacity to adequately respond to food crises and nutrition; (c) Improving in a coordinated and accelerated manner cross-sectoral efforts to increase capacity for diversified local and regional food production, ensure nutritional and food security and access to drinking water, and enhance the resilience of the most vulnerable, particularly in countries facing protracted or recurrent crises; (d) Reaffirming at global level the central role of sustainable agriculture and fisheries and aquaculture, including smallholder agriculture, livestock-keeping and pastoralism for increased food security, poverty eradication, job creation, equitable and sustainable access to, and management of resources, including land and land rights, water, open source seeds and other agricultural inputs and (micro) credit, mitigating and adapting to climate change, resilience and healthy ecosystems; (e) Providing innovations through international research and reinforce global knowledge and expertise, promotion and reinforcement of local and autonomous adaptation strategies, in particular related to climate change adaptation and mitigation, agrobiodiversity, global and inclusive value chains, fair trade, food safety, responsible investments, governance of land and natural resource tenure. D. PARTNERSHIPS 1. Strengthen the role of local authorities as actors of development through: (a) Increasing the institutional and operational capacity of European and partner countries\u2019 local authorities and their networks and alliances, as development actors and partners in policy-making to contribute to the formulation, implementation and monitoring of policies and agreements with a focus on the interests of local communities; to enhance their role in raising awareness about decentralisation reform, local and urban development; to ensure a substantive and continued structured policy dialogue in the field of development and to promote democratic governance, in particular through the Territorial Approach to Local Development including decentralisation processes, participation and accountability; (b) Increasing interactions with European citizens on Development Education and Awareness Raising (including knowledge sharing and engagement), in particular in relation to the SDGs, including in the Union and associated territories as well as candidate countries and potential candidate countries. 2. Promote inclusive societies and multi-stakeholder initiatives, good economic governance, including fair and inclusive domestic revenue mobilisation, especially in the context of international tax cooperation by implementing measures against tax avoidance and evasion, transparent public finance management and effective and inclusive public spending in line with human rights obligations and principles of good governance. 3. Support the assessment and documentation of progress in implementing partnership and effectiveness principles. ANNEX IV AREAS OF INTERVENTION FOR RAPID RESPONSE ACTIONS 1. Actions contributing to peace, stability and conflict prevention in situations of urgency, emerging crisis, crisis and post-crisis, including those which may result from migratory flows and forced displacement. Rapid response actions referred to in point (a) of Article 4(4) shall be designed for an effective, efficient, integrated and conflict sensitive Union response to the following exceptional and unforeseen situations: (a) a situation of urgency, crisis, fragility, hybrid threats, emerging crisis or natural disasters, where relevant for stability, peace and security; (b) a situation posing a threat to peace, democracy, law and order, the protection of human rights and fundamental freedoms, or the security and safety of individuals, in particular those exposed to sexual and gender-based violence in situations of instability; (c) a situation threatening to escalate into armed conflict or to severely destabilise the third country or countries concerned. Those rapid response actions may cover the following: (a) support, through the provision of technical and logistical assistance, for the efforts undertaken by international, regional and local organisations and by State and civil society actors in promoting confidence-building, mediation, dialogue and reconciliation, transitional justice, women\u2019s and youth empowerment, in particular with regard to community tensions and protracted conflicts; (b) support for the implementation of UNSCRs on women, youth, peace and security; (c) support for the establishment and functioning of interim administrations mandated in accordance with international law; (d) support for the development of democratic, pluralistic state institutions, including measures to enhance the role of women in such institutions, effective civilian administration and civilian oversight over the security system, as well as measures to strengthen the capacity of law-enforcement and judicial authorities involved in the fight against terrorism, organised crime and all forms of illicit trafficking; (e) support for international criminal tribunals and ad hoc national tribunals, truth and reconciliation commissions, transitional justice and other mechanisms for the legal settlement of human rights claims and the assertion and adjudication of property rights; (f) support for reinforcement of State capacity - in the face of significant pressures to rapidly build, maintain or restore its core functions, and basic social and political cohesion; (g) support for measures necessary to start the rehabilitation and reconstruction of key infrastructure, housing, public buildings and economic assets, and essential productive capacity, as well as other measures for the re-starting of economic activity, the generation of employment and the establishment of the minimum conditions necessary for sustainable social development; (h) support for civilian measures related to the demobilisation and reintegration of former combatants and their families into civil society, and where appropriate their repatriation, as well as measures to address the situation of child soldiers and female combatants; (i) support for measures to mitigate the social effects of restructuring the armed forces; (j) support for measures to address, within the framework of Union cooperation policies and their objectives, the socio-economic impact on the civilian population of anti-personnel landmines, unexploded ordnance or explosive remnants of war. Activities financed under the Instrument may cover, inter alia, risk education, mine detection and clearance and, in conjunction therewith, stockpile destruction; (k) support for measures to combat, within the framework of Union cooperation policies and their objectives, the illicit use of and access to firearms, small arms and light weapons; (l) support for measures to ensure that the specific needs of women and children in crisis and conflict situations, including preventing their exposure to gender-based violence, are adequately met; (m) support for the rehabilitation and reintegration of the victims of armed conflict, including measures to address the specific needs of women and children; (n) support for measures to promote and defend respect for human rights and fundamental freedoms, democracy and the rule of law, and the related international instruments; (o) support for socio-economic measures to promote equitable access to, and transparent management of, natural resources in a situation of crisis or emerging crisis, including peacebuilding; (p) support for measures to address the potential impact of sudden population movements with relevance to the political and security situation, including measures addressing the needs of host communities; (q) support for measures to promote the development and organisation of civil society and its participation in the political process, including measures to enhance the role of women in such processes and measures to promote independent, pluralist and professional media; (r) support for measures in response to natural or man-made disasters which pose a threat to stability, and to threats to public health linked to pandemics, in the absence of, or by way of complement to, Union humanitarian and civil protection assistance; (s) capacity building of military actors in support of development and security for development, in accordance with Article 9. 2. Actions contributing to strengthening resilience and linking humanitarian aid, development actions and, where relevant, peacebuilding Rapid response actions referred to in point (b) of Article 4(4) shall be designed to effectively strengthen resilience and to increase coordination, coherence and complementarity between humanitarian aid, development actions and, where relevant, peacebuilding which cannot be swiftly addressed through geographic and thematic programmes. Those rapid response actions may cover the following: (a) strengthen resilience, tackle factors of fragility and address potential drivers of conflict by supporting individuals, communities, institutions, and countries to better prepare for, withstand, adapt to and quickly recover from political, economic, and societal pressures and shocks, natural or man-made disasters, conflicts, pandemics and global threats, including by identifying and strengthening their existing capacities; by reinforcing the capacity of a state - in the face of significant pressures to rapidly build, maintain or restore its core functions, and basic social and political cohesion, as well as supporting societies, communities and individuals to manage opportunities and risks in a peaceful and conflict sensitive manner and to build, maintain or restore livelihoods and social services in the face of major pressures by supporting relevant international and multilateral initiatives for the same ends; (b) mitigate the short-term adverse effects resulting from exogenous shocks creating macroeconomic instability and aim at safeguarding socio-economic reforms and priority public expenditure for socio-economic development and poverty reduction; (c) carry out short-term rehabilitation and reconstruction to enable the victims from natural or man-made disasters, conflicts and global threats to benefit from a minimum of socio-economic standards and, as soon as possible, create the conditions for a resumption of development on the basis of long-term objectives set by the countries and regions concerned and affected populations; this includes addressing the urgent and immediate needs arising from the displacement of people and the communities that host them following natural or man-made disasters; (d) assist the region, state, at national or local level, or relevant international or civil society organisations, in setting up short term disaster prevention and preparedness mechanisms, including for prediction and early warning, with a view to reducing the consequences of disasters; (e) support measures operationalising integrated approaches particularly by improving coordination and the application of conflict sensitive approaches by humanitarian, development and, where relevant, peacebuilding actors. 3. Actions addressing Union foreign policy needs and priorities Rapid response actions to support the objectives set out in point (c) of Article 4(4) shall support Union foreign policy across political, economic and security issues. Those actions shall enable the Union to act where there is an urgent or imperative foreign policy interest, or a window of opportunity to achieve its objectives, requiring a rapid reaction and which are difficult to address by other means. Those rapid response actions may cover the following: (a) support for the Union\u2019s bilateral, regional and inter-regional cooperation strategies, promoting policy dialogue and developing collective approaches and responses to challenges of global concern, such as migration and forced displacement, climate change and security issues, including mediation, and exploiting windows of opportunity in this regard; (b) support for Union trade policy and the negotiation, implementation and enforcement of trade agreements; and for improving access to partner country markets and boosting trade, investment and business opportunities for companies from the Union, in particular SMEs, while eliminating barriers to market access and investment and protecting intellectual property rights, by means of economic diplomacy, business and regulatory cooperation, with the adaptations necessary for the specific situation of the partner country, taking into account the principle of policy coherence for development as laid down in Articles 208 and 212 TFEU and the international commitments referred to in Article 3(1) of this Regulation; (c) contributions to the implementation of the international dimension of internal Union policies such as, inter alia, environment, climate change, energy, science and education and cooperation on management and governance of the oceans as well as supporting regulatory convergence; (d) promotion of widespread understanding and visibility of the Union and of its role on the world scene, by means of strategic communication, public diplomacy, people-to-people contacts, cultural diplomacy, cooperation in educational and academic matters, and outreach activities to promote the Union\u2019s values and interests. Those rapid response actions shall execute innovative policies or initiatives, corresponding to current or evolving short- to medium-term needs, opportunities and priorities, including with the potential of informing future actions under geographic or thematic programmes. Those actions shall focus on deepening the Union\u2019s relations and dialogue and building partnerships and alliances with key countries of strategic interest, especially those emerging economies and middle-income countries who play an increasingly important role in world affairs, global governance, foreign policy, the international economy, and multilateral fora. ANNEX V PRIORITY AREAS OF THE EFSD+ OPERATIONS COVERED BY THE EXTERNAL ACTION GUARANTEE The EFSD+ operations eligible for support through the External Action Guarantee shall in particular aim at the following priority areas: (a) provide finance and support to private and cooperative sector development that complies with the conditions set out in Article 209(2) of the Financial Regulation and in line with the purpose of Article 31(2) of this Regulation, with a particular focus on local companies and SMEs, on promoting decent job creation on the basis of the core ILO labour standards and encouraging the contribution of European companies to the EFSD+ purpose; (b) address bottlenecks to private investments by providing financial instruments, which may be denominated in the local currency of the partner country concerned, including first loss guarantees to portfolios, guarantees to private sector projects such as loan guarantees for SMEs, and guarantees for specific risks for infrastructure projects and other risk capital; (c) leverage private sector financing, with a particular focus on SMEs, by addressing bottlenecks and obstacles to investment; (d) strengthen socio-economic sectors and areas and related public and private infrastructure and sustainable connectivity, including renewable and sustainable energy, water and waste management, transport, information and communications technologies, as well as environment, sustainable use of natural resources, sustainable agriculture and blue economy, sustainable forest management and landscape restoration, social infrastructure, health, and human capital, in order to improve the socio-economic environment; (e) contribute to climate action and environmental protection and management; (f) contribute by promoting sustainable development, to addressing specific socio-economic root causes of irregular migration and root causes of forced displacement, and contributing to the sustainable reintegration of returned migrants in their countries of origin, as well as fostering the resilience of transit and host communities, with due regard to the strengthening of the rule of law, good governance and human rights. ANNEX VI LIST OF KEY PERFORMANCE INDICATORS In coherence with the SDGs, the following non-exhaustive list of key performance indicators shall be used to help measure the Union\u2019s contribution to the achievement of the specific objectives of the Instrument: (1) The Rule of Law score in relation to countries benefiting from Union assistance. (2) Proportion of population below the international poverty line by sex, age, employment status and geographical location (urban/rural). (3) Number of women of reproductive age, adolescent girls, and children under 5 reached by nutrition programmes with Union support. (4) Number of smallholders reached with Union supported interventions aimed to increase their sustainable production, access to markets and/or security of land. (5) Number of 1-year olds fully immunised with Union support. (6) Number of students enrolled in education: (a) primary education (b) secondary education; and number of people who have benefitted from institution or workplace-based vocational education and training / skills development interventions, supported by the Union. (7) Greenhouse gas emissions avoided (Ktons CO2eq) with Union support. (8) Area of marine, terrestrial and freshwater ecosystems protected and/or sustainably managed with Union support. (9) Leverage of investments and multiplier effect achieved. (10) Number of individuals directly benefiting from Union supported interventions that specifically aim to support civilian post-conflict peace building or conflict prevention. (11) Number of processes related to partner country practices on trade, investment and business, or promoting the external dimension of Union internal policies or Union interest, which have been influenced. (12) Number of individuals with access to improved drinking water source and/or sanitation facilitation with Union support. (13) Number of migrants, refugees and internally displaced people or individuals from host communities protected or assisted with Union support. (14) Number of countries and cities with climate change and/or disaster risk reduction strategies (a) developed or (b) under implementation with Union support. (15) Number of SMEs applying sustainable consumptions and productions practice with Union support. (16) Renewable energy generation capacity installed (MW) with Union support. (17) Proportion of Union funded cooperation promoting gender equality and women\u2019s empowerment. (18) Number of victims of human right violations directly benefiting from assistance funded by the Union. (19) Number of Union funded initiatives supporting the implementation of political, economic and social reforms and joint agreements in partner countries. All indicators referring to individuals shall be disaggregated, whenever possible, by sex, in particular to monitor progress towards gender equality, and age. All indicators shall be disaggregated by the Instrument\u2019s geographic areas whenever possible.", "summary": "Global Europe \u2014 the EU Neighbourhood, Development and International Cooperation Instrument Global Europe \u2014 the EU Neighbourhood, Development and International Cooperation Instrument SUMMARY OF: Regulation (EU) 2021/947 establishing the Neighbourhood, Development and International Cooperation Instrument \u2014 Global Europe WHAT IS THE AIM OF THE REGULATION? The regulation sets up the Neighbourhood, Development and International Cooperation Instrument \u2014 Global Europe (NDICI-Global Europe). It is designed to uphold and promote European Union (EU) values, principles and fundamental interests worldwide in order to pursue the objectives and principles of the EU\u2019s external action, to give the EU the flexibility to respond more quickly to new crises and challenges, to increase the effectiveness and visibility of the EU\u2019s external policies and to strengthen their coordination with internal policies. It aims to: contribute to the reduction and, in the long term, the eradication of poverty; consolidate, support and promote democracy, rule of law and respect for human rights; promote sustainable development and the fight against climate change; address irregular migration and forced displacement, including their root causes; contribute to the promotion of multilateralism and the achievement of the international commitments and objectives that the EU has agreed to, in particular the sustainable development goals (SDGs), the 2030 agenda and the Paris Agreement; promote stronger partnerships with non-EU countries, including with the European neighbourhood, based on mutual interests and ownership, with a view to fostering stabilisation, good governance and resilience. KEY POINTS Single instrument The regulation creates a single instrument, bringing together 10 separate instruments from the 2014-2020multiannual financial framework (MFF) and the European Development Fund, which was previously outside the EU budget. Objectives The regulation has a number of specific objectives: to support and foster dialogue and cooperation with non-EU countries and regions in the European neighbourhood, in sub-Saharan Africa, in Asia and the Pacific, and in the Americas and the Caribbean; to develop special strengthened partnerships and enhanced political cooperation with the European neighbourhood; at global level: to protect, promote and advance human rights, including gender equality and the protection of human rights defenders,to support civil-society organisations,to further stability and peace and prevent conflict, thereby contributing to the protection of civilians,to address other global challenges such as climate change, the protection of biodiversity and the environment, and migration and mobility; to respond rapidly to: situations of crisis, instability and conflict \u2014 including those which may result from migratory flows and forced displacement \u2014 and hybrid threats,challenges to resilience, including natural and man-made disasters, and the linking of humanitarian aid and development action and the needs and priorities of the EU common foreign and security policy. Structure The instrument is organised around 3 pillars. Geographical \u2014 promoting partnerships through cooperation with partner countries and focusing on issues such as: good governance;inclusive growth;climate and environment objectives;poverty eradication; andconflict prevention. Thematic \u2014 funding actions linked to the sustainable development goals at the global level and focusing on issues such as human rights and democracy, civil society, stability and peace, along with global challenges such as: health;education and training;women and children;culture;migration; andclimate change. Rapid response. Priorities The instrument has a number of targets, including: having at least 93% of the expenditure under the Instrument fulfil the criteria for official development assistance, established by the Development Assistance Committee of the Organisation for Economic Cooperation and Development (OECD); focusing at least 20% of official development assistance expenditure on human development; dedicating 30% to fighting climate change; indicatively dedicating 10% to migration-related activities, ensuring that at least 85% of actions have gender equality as a principal or significant objective, of which at least 5% should have gender equality as a principal objective. Investment framework The instrument contains an investment framework, a basis for financing external action from the geographical pillar to raise additional funds for sustainable development from the public and private sector. It consists of: the European Fund for Sustainable Development Plus (EFSD+); and the external action guarantee. Budget The financing of the instrument covers 1 January 2021 to 31 December 2027, the duration of the MFF. It has a budget of \u20ac79.462 billion, which is broken down as follows: geographical programmes: \u20ac60.388 billion thematic programmes: \u20ac6.358 billion rapid reaction operations: \u20ac3.182 billion. Supplementing act Regulation (EU) 2021/947 was supplemented by Commission Delegated Regulation (EU) 2021/1530 of 12 July 2021. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND Global Europe: Neighbourhood, Development and International Cooperation Instrument (European Commission). MAIN DOCUMENT Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument \u2014 Global Europe, amending and repealing Decision No 466/2014/EU and repealing Regulation (EU) 2017/1601 and Council Regulation (EC, Euratom) No 480/2009 (OJ L 209, 14.6.2021, pp. 1-78) last update 02.08.2021"}
{"article": "26.11.2019 EN Official Journal of the European Union L 305/17 DIRECTIVE (EU) 2019/1937 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 October 2019 on the protection of persons who report breaches of Union law THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16, Article 43(2), Article 50, Article 53(1), Articles 91, 100, and 114, Article 168(4), Article 169, Article 192(1) and Article 325(4) thereof and to the Treaty establishing the European Atomic Energy Community, and in particular Article 31 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the Court of Auditors (1), Having regard to the opinion of the European Economic and Social Committee (2), After consulting the Committee of the Regions, Having regard to the opinion of 30 November 2018 of the Group of Experts referred to in Article 31 of the Treaty establishing the European Atomic Energy Community, Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Persons who work for a public or private organisation or are in contact with such an organisation in the context of their work-related activities are often the first to know about threats or harm to the public interest which arise in that context. By reporting breaches of Union law that are harmful to the public interest, such persons act as \u2018whistleblowers\u2019 and thereby play a key role in exposing and preventing such breaches and in safeguarding the welfare of society. However, potential whistleblowers are often discouraged from reporting their concerns or suspicions for fear of retaliation. In this context, the importance of providing balanced and effective whistleblower protection is increasingly acknowledged at both Union and international level. (2) At Union level, reports and public disclosures by whistleblowers are one upstream component of enforcement of Union law and policies. They feed national and Union enforcement systems with information, leading to effective detection, investigation and prosecution of breaches of Union law, thus enhancing transparency and accountability. (3) In certain policy areas, breaches of Union law, regardless of whether they are categorised under national law as administrative, criminal or other types of breaches, may cause serious harm to the public interest, in that they create significant risks for the welfare of society. Where weaknesses of enforcement have been identified in those areas, and whistleblowers are usually in a privileged position to disclose breaches, it is necessary to enhance enforcement by introducing effective, confidential and secure reporting channels and by ensuring that whistleblowers are protected effectively against retaliation. (4) Whistleblower protection currently provided in the Union is fragmented across Member States and uneven across policy areas. The consequences of breaches of Union law with a cross-border dimension reported by whistleblowers illustrate how insufficient protection in one Member State negatively impacts the functioning of Union policies not only in that Member State, but also in other Member States and in the Union as a whole. (5) Common minimum standards ensuring that whistleblowers are protected effectively should apply as regards acts and policy areas where there is a need to strengthen enforcement, under-reporting by whistleblowers is a key factor affecting enforcement, and breaches of Union law can cause serious harm to the public interest. Member States could decide to extend the application of national provisions to other areas with a view to ensuring that there is a comprehensive and coherent whistleblower protection framework at national level. (6) Whistleblower protection is necessary to enhance the enforcement of Union law on public procurement. It is necessary, not only to prevent and detect procurement-related fraud and corruption in the context of the implementation of the Union budget, but also to tackle insufficient enforcement of rules on public procurement by national contracting authorities and contracting entities in relation to the execution of works, the supply of products or the provision of services. Breaches of such rules create distortions of competition, increase costs for doing business, undermine the interests of investors and shareholders and, in general, lower attractiveness for investment and create an uneven playing field for all businesses across the Union, thus affecting the proper functioning of the internal market. (7) In the area of financial services, the added value of whistleblower protection has already been acknowledged by the Union legislator. In the aftermath of the financial crisis, which exposed serious shortcomings in the enforcement of the relevant rules, measures for the protection of whistleblowers, including internal and external reporting channels, as well as an explicit prohibition of retaliation, were introduced in a significant number of legislative acts in the area of financial services as indicated by the Commission in its communication of 8 December 2010 entitled \u2018Reinforcing sanctioning regimes in the financial services sector\u2019. In particular, in the context of the prudential framework applicable to credit institutions and investment firms, Directive 2013/36/EU of the European Parliament and of the Council (4) provides for whistleblower protection which applies in the context of Regulation (EU) No 575/2013 of the European Parliament and of the Council (5). (8) As regards the safety of products placed on the internal market, businesses involved in the manufacturing and distribution chain are the primary source of evidence, with the result that reporting by whistleblowers in such businesses has a high added value, since they are much closer to information about possible unfair and illicit manufacturing, import or distribution practices regarding unsafe products. Accordingly, there is a need to introduce whistleblower protection in relation to the safety requirements applicable to products regulated by the Union harmonisation legislation as set out in Annexes I and II to Regulation (EU) 2019/1020 of the European Parliament and of the Council (6), and in relation to the general product safety requirements as set out in Directive 2001/95/EC of the European Parliament and of the Council (7). Whistleblower protection as provided for in this Directive would also be instrumental in avoiding diversion of firearms, their parts and components and ammunition, as well as of defence-related products, since it would encourage the reporting of breaches of Union law, such as document fraud, altered marking and fraudulent acquisition of firearms within the Union where breaches often imply a diversion from the legal to the illegal market. Whistleblower protection as provided for in this Directive would also help prevent the illicit manufacture of homemade explosives by contributing to the correct application of restrictions and controls regarding explosives precursors. (9) The importance of whistleblower protection in terms of preventing and deterring breaches of Union rules on transport safety, which can endanger human lives, has already been acknowledged in sectorial Union acts on aviation safety, namely in Regulation (EU) No 376/2014 of the European Parliament and of the Council (8), and maritime transport safety, namely in Directives 2013/54/EU (9) and 2009/16/EC (10) of the European Parliament and of the Council, which provide for tailored measures of protection for whistleblowers as well as specific reporting channels. Those acts also provide for the protection of workers who report their own honest mistakes against retaliation, so-called \u2018just culture\u2019. It is necessary to complement the existing elements of whistleblower protection in those two sectors, as well as to provide protection in other transport modes, namely inland waterway, road and railway transport, to enhance the enforcement of safety standards as regards those transport modes. (10) As regards the area of protection of the environment, evidence-gathering, preventing, detecting and addressing environmental crimes and unlawful conduct remain a challenge and actions in that regard need to be reinforced, as acknowledged by the Commission in its communication of 18 January 2018 entitled \u2018EU actions to improve environmental compliance and governance\u2019. Given that before the entry into force of this Directive, the only existing whistleblower protection rules related to environmental protection are provided for in one sectorial act, namely Directive 2013/30/EU of the European Parliament and of the Council (11), the introduction of such protection is necessary to ensure effective enforcement of the Union environmental acquis, the breaches of which can cause harm to the public interest with possible spillover impacts across national borders. The introduction of such protection is also relevant in cases where unsafe products can cause environmental harm. (11) Enhancing whistleblower protection would also contribute to preventing and deterring breaches of European Atomic Energy Community rules on nuclear safety, radiation protection and responsible and safe management of spent fuel and radioactive waste. It would also strengthen the enforcement of the relevant provisions of Council Directive 2009/71/Euratom (12), concerning promotion and enhancement of an effective nuclear safety culture and, in particular, point (a) of Article 8b(2) of that Directive, which requires, inter alia, that the competent regulatory authority establishes management systems which give due priority to nuclear safety and promote, at all levels of staff and management, the ability to question the effective delivery of relevant safety principles and practices and to report in a timely manner on safety issues. (12) The introduction of a whistleblower protection framework would also contribute to strengthening the enforcement of existing provisions, and to preventing breaches of Union rules, in the area of the food chain and, in particular, on food and feed safety, as well as on animal health, protection and welfare. The different Union rules laid down in those areas are closely interlinked. Regulation (EC) No 178/2002 of the European Parliament and of the Council (13) sets out the general principles and requirements which underpin all Union and national measures relating to food and feed, with a particular focus on food safety, in order to ensure a high level of protection of human health and consumers' interests in relation to food, as well as the effective functioning of the internal market. That Regulation provides, inter alia, that food and feed business operators are prevented from discouraging their employees and others from cooperating with competent authorities where such cooperation could prevent, reduce or eliminate a risk arising from food. The Union legislator has taken a similar approach in the area of animal health through Regulation (EU) 2016/429 of the European Parliament and of the Council (14) establishing the rules for the prevention and control of animal diseases which are transmissible to animals or to humans and in the area of the protection and well-being of animals kept for farming purposes, of animals used for scientific purposes, of animals during transport and of animals at the time of killing, through Council Directive 98/58/EC (15) and Directive 2010/63/EU of the European Parliament and of the Council (16), as well as Council Regulations (EC) No 1/2005 (17) and (EC) No 1099/2009 (18), respectively. (13) The reporting of breaches by whistleblowers can be key to detecting and preventing, reducing or eliminating risks to public health and to consumer protection resulting from breaches of Union rules, which might otherwise remain hidden. In particular, consumer protection is also strongly linked to cases where unsafe products can cause considerable harm to consumers. (14) Respect for privacy and protection of personal data, which are enshrined as fundamental rights in Articles 7 and 8 of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019), are other areas in which whistleblowers can help to disclose breaches, which can harm the public interest. Whistleblowers can also help disclose breaches of Directive (EU) 2016/1148 of the European Parliament and of the Council (19) on the security of network and information systems, which introduces a requirement to provide notification of incidents, including those that do not compromise personal data, and security requirements for entities providing essential services across many sectors, for example energy, health, transport and banking, for providers of key digital services, for example cloud computing services, and for suppliers of basic utilities, such as water, electricity and gas. Whistleblowers' reporting in this area is particularly valuable for the prevention of security incidents that would affect key economic and social activities and widely used digital services, as well as for the prevention of any infringement of Union data protection rules. Such reporting helps ensure the continuity of services that are essential for the functioning of the internal market and the wellbeing of society. (15) Furthermore, the protection of the financial interests of the Union, which is related to the fight against fraud, corruption and any other illegal activity affecting Union expenditure, the collection of Union revenues and funds or Union assets, is a core area in which enforcement of Union law needs to be strengthened. The strengthening of the protection of the financial interests of the Union is relevant also for the implementation of the Union budget as regards expenditure that is incurred on the basis of the Treaty establishing the European Atomic Energy Community (Euratom Treaty). Lack of effective enforcement in the area of protection of the financial interests of the Union, including as regards prevention of fraud and corruption at national level, leads to a decrease of Union revenues and a misuse of Union funds, which can distort public investments, hinder growth and undermine citizens' trust in Union action. Article 325 of the Treaty on the Functioning of the European Union (TFEU) requires the Union and the Member States to counter fraud and any other illegal activities affecting the financial interests of the Union. Relevant Union measures in this respect include, in particular, Council Regulation (EC, Euratom) No 2988/95 (20) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (21). Regulation (EC, Euratom) No 2988/95 is complemented, for the most serious types of fraud-related conduct, by Directive (EU) 2017/1371 of the European Parliament and of the Council (22) and by the Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities' financial interests of 26 July 1995 (23), including the Protocols thereto of 27 September 1996 (24), of 29 November 1996 (25) and of 19 June 1997 (26). That Convention and those Protocols remain in force for the Member States not bound by Directive (EU) 2017/1371. (16) Common minimum standards for the protection of whistleblowers should also be laid down for breaches relating to the internal market as referred to in Article 26(2) TFEU. In addition, in accordance with the case law of the Court of Justice of the European Union (the \u2018Court\u2019), Union measures aimed at establishing or ensuring the functioning of the internal market are intended to contribute to the elimination of existing or emerging obstacles to the free movement of goods or to the freedom to provide services, and to contribute to the removal of distortions of competition. (17) Specifically, the protection of whistleblowers to enhance the enforcement of Union competition law, including concerning State aid, would serve to safeguard the efficient functioning of markets in the Union, allow a level playing field for business and deliver benefits to consumers. As regards competition rules applying to undertakings, the importance of insider reporting in detecting competition law infringements has already been recognised in the leniency policy pursued by the Commission under Article 4a of Commission Regulation (EC) No 773/2004 (27) as well as with the recent introduction of an anonymous whistleblower tool by the Commission. Breaches relating to competition law and State aid rules concern Articles 101, 102, 106, 107 and 108 TFEU and rules of secondary law adopted for their application. (18) Breaches of corporate tax law and arrangements of which the purpose is to obtain a tax advantage and to evade legal obligations, thereby defeating the object or purpose of the applicable corporate tax law, negatively affect the proper functioning of the internal market. Such breaches and arrangements can give rise to unfair tax competition and extensive tax evasion, distorting the level playing field for businesses and resulting in a loss of tax revenues for Member States and for the Union budget as a whole. This Directive should provide for protection against retaliation for persons who report evasive and/or abusive arrangements that could otherwise go undetected, with a view to strengthening the ability of competent authorities to safeguard the proper functioning of the internal market and remove distortions and barriers to trade that affect the competitiveness of businesses in the internal market, and that are directly linked to the free movement rules and are also relevant for the application of the State aid rules. Whistleblower protection as provided for in this Directive would add to recent Commission initiatives aimed at improving transparency and the exchange of information in the field of taxation, and creating a fairer corporate tax environment within the Union with a view to increasing Member States' effectiveness in identifying evasive and/or abusive arrangements, and would help deter such arrangements. However, this Directive does not harmonise provisions relating to taxes, whether substantive or procedural, and does not seek to strengthen the enforcement of national corporate tax rules, without prejudice to the possibility of Member States to use reported information for that purpose. (19) Point (a) of Article 2(1) defines the material scope of this Directive by means of a reference to a list of Union acts set out in the Annex. This implies that where those Union acts, in turn, define their material scope by reference to Union acts listed in their annexes, the latter acts also form part of the material scope of this Directive. In addition, the reference to the acts in the Annex should be understood as including all national and Union implementing or delegated measures adopted pursuant to those acts. Moreover, the reference to the Union acts in the Annex is to be understood as a dynamic reference, in accordance with the standard referencing system for legal acts of the Union. Thus, if a Union act in the Annex has been or is amended, the reference relates to the act as amended; if a Union act in the Annex has been or is replaced, the reference relates to the new act. (20) Certain Union acts, in particular in the area of financial services, such as Regulation (EU) No 596/2014 of the European Parliament and of the Council (28), and Commission Implementing Directive (EU) 2015/2392 (29), adopted on the basis of that Regulation, already contain detailed rules on whistleblower protection. Any specific rules in that regard provided for in such existing Union legislation, including the Union acts listed in Part II of the Annex to this Directive, which are tailored to the relevant sectors, should be maintained. This is of particular importance for ascertaining which legal entities in the area of financial services, the prevention of money laundering and terrorist financing are currently obliged to establish internal reporting channels. At the same time, in order to ensure consistency and legal certainty across Member States, this Directive should be applicable in respect of all matters not regulated under the sector-specific acts, and thereby should complement such acts, so that they are fully aligned with minimum standards. In particular, this Directive should provide further detail as to the design of the internal and external reporting channels, the obligations of competent authorities, and the specific forms of protection to be provided at national level against retaliation. In that regard, Article 28(4) of Regulation (EU) No 1286/2014 of the European Parliament and of the Council (30) provides for Member States to be able to provide for an internal reporting channel in the area covered by that Regulation. For reasons of consistency with the minimum standards laid down by this Directive, the obligation to establish internal reporting channels provided for in this Directive should also apply in respect of Regulation (EU) No 1286/2014. (21) This Directive should be without prejudice to the protection granted to workers when reporting breaches of Union employment law. In particular, in the area of occupational safety and health, Article 11 of Council Directive 89/391/EEC (31) already requires Member States to ensure that workers or workers' representatives are not placed at a disadvantage because of requests or proposals they make to employers to take appropriate measures to mitigate hazards for workers and/or to remove sources of danger. Workers and their representatives are entitled, under that Directive, to raise issues with the competent authority if they consider that the measures taken, and the means employed, by the employer are inadequate for the purposes of ensuring safety and health. (22) Member States could decide to provide that reports concerning interpersonal grievances exclusively affecting the reporting person, namely grievances about interpersonal conflicts between the reporting person and another worker, can be channelled to other procedures. (23) This Directive should be without prejudice to the protection granted by the procedures for reporting possible illegal activities, including fraud or corruption, that are detrimental to the interests of the Union, or for reporting conduct relating to the discharge of professional duties, which could constitute a serious failure to comply with the obligations of officials and other servants of the European Union established under Articles 22a, 22b and 22c of the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (32). This Directive should apply where officials and other servants of the Union report breaches that occur in a work-related context outside their employment relationship with the Union institutions, bodies, offices or agencies. (24) National security remains the sole responsibility of each Member State. This Directive should not apply to reports of breaches related to procurement involving defence or security aspects where those are covered by Article 346 TFEU, in accordance with the case law of the Court. If Member States decide to extend the protection provided under this Directive to further areas or acts, which are not within its material scope, it should be possible for them to adopt specific provisions to protect essential interests of national security in that regard. (25) This Directive should also be without prejudice to the protection of classified information which Union law or the laws, regulations or administrative provisions in force in the Member State concerned require, for security reasons, to be protected from unauthorised access. Moreover, this Directive should not affect the obligations arising from Council Decision 2013/488/EU (33) or Commission Decision (EU, Euratom) 2015/444 (34). (26) This Directive should not affect the protection of confidentiality of communications between lawyers and their clients (\u2018legal professional privilege\u2019) as provided for under national and, where applicable, Union law, in accordance with the case law of the Court. Moreover, this Directive should not affect the obligation of maintaining the confidential nature of communications of health care providers, including therapists, with their patients and of patient records (\u2018medical privacy\u2019) as provided for under national and Union law. (27) Members of professions other than lawyers and health care providers should be able to qualify for protection under this Directive when they report information protected by the applicable professional rules, provided that reporting that information is necessary for the purposes of revealing a breach falling within the scope of this Directive. (28) While this Directive should provide, under certain conditions, for a limited exemption from liability, including criminal liability, in the event of a breach of confidentiality, it should not affect national rules on criminal procedure, particularly those aiming at safeguarding the integrity of the investigations and proceedings or the rights of defence of persons concerned. This should be without prejudice to the introduction of measures of protection into other types of national procedural law, in particular, the reversal of the burden of proof in national administrative, civil or labour proceedings. (29) This Directive should not affect national rules on the exercise of the rights of employees' representatives to information, consultation, and participation in collective bargaining and their defence of workers' employment rights. This should be without prejudice to the level of protection granted under this Directive. (30) This Directive should not apply to cases in which persons who, having given their informed consent, have been identified as informants or registered as such in databases managed by authorities appointed at national level, such as customs authorities, and report breaches to enforcement authorities, in return for reward or compensation. Such reports are made pursuant to specific procedures that aim to guarantee the anonymity of such persons in order to protect their physical integrity, and that are distinct from the reporting channels provided for under this Directive. (31) Persons who report information about threats or harm to the public interest obtained in the context of their work-related activities make use of their right to freedom of expression. The right to freedom of expression and information, enshrined in Article 11 of the Charter and in Article 10 of the Convention for the Protection of Human Rights and Fundamental Freedoms, encompasses the right to receive and impart information as well as the freedom and pluralism of the media. Accordingly, this Directive draws upon the case law of the European Court of Human Rights (ECHR) on the right to freedom of expression, and the principles developed on this basis by the Council of Europe in its Recommendation on the Protection of Whistleblowers adopted by its Committee of Ministers on 30 April 2014. (32) To enjoy protection under this Directive, reporting persons should have reasonable grounds to believe, in light of the circumstances and the information available to them at the time of reporting, that the matters reported by them are true. That requirement is an essential safeguard against malicious and frivolous or abusive reports as it ensures that those who, at the time of the reporting, deliberately and knowingly reported wrong or misleading information do not enjoy protection. At the same time, the requirement ensures that protection is not lost where the reporting person reported inaccurate information on breaches by honest mistake. Similarly, reporting persons should be entitled to protection under this Directive if they have reasonable grounds to believe that the information reported falls within its scope. The motives of the reporting persons in reporting should be irrelevant in deciding whether they should receive protection. (33) Reporting persons normally feel more at ease reporting internally, unless they have reasons to report externally. Empirical studies show that the majority of whistleblowers tend to report internally, within the organisation in which they work. Internal reporting is also the best way to get information to the persons who can contribute to the early and effective resolution of risks to the public interest. At the same time, the reporting person should be able to choose the most appropriate reporting channel depending on the individual circumstances of the case. Moreover, it is necessary to protect public disclosures, taking into account democratic principles such as transparency and accountability, and fundamental rights such as freedom of expression and the freedom and pluralism of the media, whilst balancing the interest of employers to manage their organisations and to protect their interests, on the one hand, with the interest of the public to be protected from harm, on the other, in line with the criteria developed in the case law of the ECHR. (34) Without prejudice to existing obligations to provide for anonymous reporting by virtue of Union law, it should be possible for Member States to decide whether legal entities in the private and public sector and competent authorities are required to accept and follow up on anonymous reports of breaches which fall within the scope of this Directive. However, persons who anonymously reported or who made anonymous public disclosures falling within the scope of this Directive and meet its conditions should enjoy protection under this Directive if they are subsequently identified and suffer retaliation. (35) This Directive should provide for protection to be granted in cases where persons report, pursuant to Union legislation, to institutions, bodies, offices or agencies of the Union, for example in the context of fraud concerning the Union budget. (36) Persons need specific legal protection where they acquire the information they report through their work-related activities and therefore run the risk of work-related retaliation, for instance, for breaching the duty of confidentiality or loyalty. The underlying reason for providing such persons with protection is their position of economic vulnerability vis-\u00e0-vis the person on whom de facto they depend for work. Where there is no such work-related power imbalance, for instance in the case of ordinary complainants or citizen bystanders, there is no need for protection against retaliation. (37) Effective enforcement of Union law requires that protection should be granted to the broadest possible range of categories of persons, who, irrespective of whether they are Union citizens or third-country nationals, by virtue of their work-related activities, irrespective of the nature of those activities and of whether they are paid or not, have privileged access to information on breaches that it would be in the public interest to report and who may suffer retaliation if they report them. Member States should ensure that the need for protection is determined by reference to all the relevant circumstances and not merely by reference to the nature of the relationship, so as to cover the whole range of persons connected in a broad sense to the organisation where the breach has occurred. (38) Protection should, firstly, apply to persons having the status of \u2018workers\u2019, within the meaning of Article 45(1) TFEU, as interpreted by the Court, namely persons who, for a certain period of time, perform services for and under the direction of another person, in return for which they receive remuneration. Protection should, thus, also be granted to workers in non-standard employment relationships, including part-time workers and fixed-term contract workers, as well as persons with a contract of employment or employment relationship with a temporary agency, precarious types of relationships where standard forms of protection against unfair treatment are often difficult to apply. The concept of \u2018worker\u2019 also includes civil servants, public service employees, as well as any other persons working in the public sector. (39) Protection should also extend to categories of natural persons, who, whilst not being \u2018workers\u2019 within the meaning of Article 45(1) TFEU, can play a key role in exposing breaches of Union law and may find themselves in a position of economic vulnerability in the context of their work-related activities. For instance, as regards product safety, suppliers are much closer to the source of information about possible unfair and illicit manufacturing, import or distribution practices concerning unsafe products; and as regards the implementation of Union funds, consultants providing their services are in a privileged position to draw attention to breaches they witness. Such categories of persons, which include self-employed persons providing services, freelance workers, contractors, subcontractors and suppliers, are typically subject to retaliation, which can take the form, for instance, of early termination or cancellation of a contract for services, a licence or permit, loss of business, loss of income, coercion, intimidation or harassment, blacklisting or business boycotting or damage to their reputation. Shareholders and persons in managerial bodies can also suffer retaliation, for instance in financial terms or in the form of intimidation or harassment, blacklisting or damage to their reputation. Protection should also be granted to persons whose work-based relationship has ended, and to candidates for employment or persons seeking to provide services to an organisation, who acquire information on breaches during the recruitment process or another pre-contractual negotiation stage, and who could suffer retaliation, for instance in the form of negative employment references, blacklisting or business boycotting. (40) Effective whistleblower protection implies protecting also categories of persons who, whilst not relying on their work-related activities economically, can nevertheless suffer retaliation for reporting breaches. Retaliation against volunteers and paid or unpaid trainees could take the form of no longer making use of their services, or of giving them a negative employment reference or otherwise damaging their reputation or career prospects. (41) Protection should be provided against retaliatory measures taken not only directly vis-\u00e0-vis reporting persons themselves, but also those that can be taken indirectly, including vis-\u00e0-vis facilitators, colleagues or relatives of the reporting person who are also in a work-related connection with the reporting person's employer or customer or recipient of services. Without prejudice to the protection that trade union representatives or employees' representatives enjoy in their capacity as such representatives under other Union and national rules, they should enjoy the protection provided for under this Directive both where they report in their capacity as workers and where they have provided advice and support to the reporting person. Indirect retaliation also includes actions taken against the legal entity that the reporting person owns, works for or is otherwise connected with in a work-related context, such as denial of provision of services, blacklisting or business boycotting. (42) Effective detection and prevention of serious harm to the public interest requires that the notion of breach also includes abusive practices, as defined by the case law of the Court, namely acts or omissions which do not appear to be unlawful in formal terms but defeat the object or the purpose of the law. (43) Effective prevention of breaches of Union law requires that protection is granted to persons who provide information necessary to reveal breaches which have already taken place, breaches which have not yet materialised, but are very likely to take place, acts or omissions which the reporting person has reasonable grounds to consider as breaches, as well as attempts to conceal breaches. For the same reasons, protection is justified also for persons who do not provide positive evidence but raise reasonable concerns or suspicions. At the same time, protection should not apply to persons who report information which is already fully available in the public domain or unsubstantiated rumours and hearsay. (44) There should be a close link between reporting and the adverse treatment suffered, directly or indirectly, by the reporting person, for that adverse treatment to be considered to be retaliation and consequently for the reporting person to be able to enjoy legal protection in that respect. Effective protection of reporting persons as a means of enhancing the enforcement of Union law requires a broad definition of retaliation, encompassing any act or omission occurring in a work-related context and which causes them detriment. This Directive should not, however, prevent employers from taking employment-related decisions which are not prompted by the reporting or public disclosure. (45) Protection against retaliation as a means of safeguarding freedom of expression and the freedom and pluralism of the media should be provided both to persons who report information about acts or omissions within an organisation (\u2018internal reporting\u2019) or to an outside authority (\u2018external reporting\u2019) and to persons who make such information available in the public domain, for instance, directly to the public through online platforms or social media, or to the media, elected officials, civil society organisations, trade unions, or professional and business organisations. (46) Whistleblowers are, in particular, important sources for investigative journalists. Providing effective protection to whistleblowers from retaliation increases legal certainty for potential whistleblowers and thereby encourages whistleblowing also through the media. In this respect, protection of whistleblowers as journalistic sources is crucial for safeguarding the \u2018watchdog\u2019 role of investigative journalism in democratic societies. (47) For the effective detection and prevention of breaches of Union law, it is vital that the relevant information reaches swiftly those closest to the source of the problem, most able to investigate and with powers to remedy it, where possible. As a principle, therefore, reporting persons should be encouraged to first use internal reporting channels and report to their employer, if such channels are available to them and can reasonably be expected to work. That is the case, in particular, where reporting persons believe that the breach can be effectively addressed within the relevant organisation, and that there is no risk of retaliation. As a consequence, legal entities in the private and public sector should establish appropriate internal procedures for receiving and following up on reports. Such encouragement also concerns cases where such channels were established without it being required by Union or national law. This principle should help foster a culture of good communication and corporate social responsibility in organisations, whereby reporting persons are considered to significantly contribute to self-correction and excellence within the organisation. (48) For legal entities in the private sector, the obligation to establish internal reporting channels should be commensurate with their size and the level of risk their activities pose to the public interest. All enterprises having 50 or more workers should be subject to the obligation to establish internal reporting channels, irrespective of the nature of their activities, based on their obligation to collect VAT. Following an appropriate risk assessment, Member States could also require other enterprises to establish internal reporting channels in specific cases, for instance due to the significant risks that may result from their activities. (49) This Directive should be without prejudice to Member States being able to encourage legal entities in the private sector with fewer than 50 workers to establish internal channels for reporting and follow-up, including by laying down less prescriptive requirements for those channels than those laid down under this Directive, provided that those requirements guarantee confidentiality and diligent follow-up. (50) The exemption of small and micro enterprises from the obligation to establish internal reporting channels should not apply to private enterprises which are obliged to establish internal reporting channels by virtue of Union acts referred to in Parts I.B and II of the Annex. (51) It should be clear that, in the case of legal entities in the private sector that do not provide for internal reporting channels, reporting persons should be able to report externally to the competent authorities and such persons should enjoy the protection against retaliation provided by this Directive. (52) In order to ensure, in particular, that the public procurement rules in the public sector are respected, the obligation to put in place internal reporting channels should apply to all contracting authorities and contracting entities, at local, regional and national level, whilst being commensurate with their size. (53) Provided the confidentiality of the identity of the reporting person is ensured, it is up to each individual legal entity in the private and public sector to define the kind of reporting channels to establish. More specifically, the reporting channels should enable persons to report in writing and submit reports by post, by physical complaint box(es), or through an online platform, whether it be on an intranet or internet platform, or to report orally, by telephone hotline or other voice messaging system, or both. Upon request by the reporting person, such channels should also enable reporting by means of physical meetings, within a reasonable timeframe. (54) Third parties could also be authorised to receive reports of breaches on behalf of legal entities in the private and public sector, provided they offer appropriate guarantees of respect for independence, confidentiality, data protection and secrecy. Such third parties could be external reporting platform providers, external counsel, auditors, trade union representatives or employees' representatives. (55) Internal reporting procedures should enable legal entities in the private sector to receive and investigate in full confidentiality reports by the workers of the entity and of its subsidiaries or affiliates (\u2018the group\u2019), but also, to any extent possible, by any of the group's agents and suppliers and by any persons who acquire information through their work-related activities with the entity and the group. (56) The choice of the most appropriate persons or departments within a legal entity in the private sector to be designated as competent to receive and follow up on reports depends on the structure of the entity, but, in any case, their function should be such as to ensure independence and absence of conflict of interest. In smaller entities, this function could be a dual function held by a company officer well placed to report directly to the organisational head, such as a chief compliance or human resources officer, an integrity officer, a legal or privacy officer, a chief financial officer, a chief audit executive or a member of the board. (57) In the context of internal reporting, informing, as far as legally possible and in the most comprehensive way possible, the reporting person about the follow-up to the report is crucial for building trust in the effectiveness of the overall system of whistleblower protection and reduces the likelihood of further unnecessary reports or public disclosures. The reporting person should be informed within a reasonable timeframe about the action envisaged or taken as follow-up to the report and the grounds for the choice of that follow-up. Follow-up could include, for instance, referral to other channels or procedures in the case of reports exclusively affecting individual rights of the reporting person, closure of the procedure based on lack of sufficient evidence or other grounds, launch of an internal enquiry and, possibly, its findings and any measures taken to address the issue raised, referral to a competent authority for further investigation, insofar as such information would not prejudice the internal enquiry or the investigation or affect the rights of the person concerned. In all cases, the reporting person should be informed of the investigation's progress and outcome. It should be possible to ask the reporting person to provide further information, during the course of the investigation, albeit without there being an obligation to provide such information. (58) A reasonable timeframe for informing a reporting person should not exceed three months. Where the appropriate follow-up is still being determined, the reporting person should be informed about this and about any further feedback to expect. (59) Persons who are considering reporting breaches of Union law should be able to make an informed decision on whether, how and when to report. Legal entities in the private and public sector that have internal reporting procedures in place should be required to provide information on those procedures as well as on external reporting procedures to relevant competent authorities. It is essential that such information be clear and easily accessible, including, to any extent possible, also to persons other than workers, who come in contact with the entity through their work-related activities, such as service-providers, distributors, suppliers and business partners. For instance, such information could be posted at a visible location accessible to all such persons and on the website of the entity, and could also be included in courses and training seminars on ethics and integrity. (60) Effective detection and prevention of breaches of Union law require ensuring that potential whistleblowers can easily and in full confidentiality bring the information they possess to the attention of the relevant competent authorities that are able to investigate and to remedy the problem, where possible. (61) It may be the case that internal channels do not exist or that they were used but did not function properly, for instance because the report was not dealt with diligently or within a reasonable timeframe, or no appropriate action was taken to address the breach despite the results of the related internal enquiry confirming the existence of a breach. (62) In other cases, the use of internal channels cannot reasonably be expected to function properly. This is most notably the case where reporting persons have valid reasons to believe that they would suffer retaliation in connection with the reporting, including as a result of a breach of confidentiality, or that competent authorities would be better placed to take effective action to address the breach. Competent authorities would be better placed, for example, where the ultimate responsibility holder within the work-related context is involved in the breach, or there is a risk that the breach or related evidence could be concealed or destroyed; or, more generally, the effectiveness of investigative actions by competent authorities might otherwise be jeopardised, such as in the case of reported cartel arrangements and other breaches of competition rules; or the breach requires urgent action, for instance to safeguard the health and safety of persons or to protect the environment. In all cases, persons reporting externally to the competent authorities and, where relevant, to institutions, bodies, offices or agencies of the Union should be protected. This Directive should also grant protection where Union or national law requires the reporting persons to report to the competent national authorities, for instance as part of their job duties and responsibilities or because the breach is a criminal offence. (63) Lack of confidence in the effectiveness of reporting is one of the main factors discouraging potential whistleblowers. Accordingly, there is a need to impose a clear obligation on competent authorities to establish appropriate external reporting channels, to diligently follow up on the reports received, and, within a reasonable timeframe, give feedback to reporting persons. (64) It should be for the Member States to designate the authorities competent to receive information on breaches falling within the scope of this Directive and give appropriate follow-up to the reports. Such competent authorities could be judicial authorities, regulatory or supervisory bodies competent in the specific areas concerned, or authorities of a more general competence at a central level within a Member State, law enforcement agencies, anticorruption bodies or ombudsmen. (65) As recipients of reports, the authorities designated as competent should have the necessary capacities and powers to ensure appropriate follow-up, including assessing the accuracy of the allegations made in the report and addressing the breaches reported by launching an internal enquiry, investigation, prosecution or action for recovery of funds, or other appropriate remedial action, in accordance with their mandate. Alternatively, those authorities should have the necessary powers to refer the report to another authority that should investigate the breach reported, while ensuring that there is appropriate follow-up by such authority. In particular, where Member States wish to establish external reporting channels at a central level, for instance in the area of State aid, Member States should put in place adequate safeguards in order to ensure that the requirements of independence and autonomy laid down in this Directive are respected. The establishment of such external reporting channels should not affect the powers of the Member States or of the Commission concerning supervision in the field of State aid, nor should this Directive affect the exclusive power of the Commission as regards the declaration of compatibility of State aid measures in particular pursuant to Article 107(3) TFEU. With regard to breaches of Articles 101 and 102 TFEU, Member States should designate as competent authorities those referred to in Article 35 of Council Regulation (EC) No 1/2003 (35) without prejudice to the powers of the Commission in this area. (66) Competent authorities should also give feedback to the reporting persons about the action envisaged or taken as follow-up, for instance, referral to another authority, closure of the procedure based on lack of sufficient evidence or other grounds, or launch of an investigation, and possibly its findings and any measures taken to address the issue raised, as well as about the grounds for the choice of that follow-up. Communications on the final outcome of the investigations should not affect the applicable Union rules, which include possible restrictions on the publication of decisions in the area of financial regulation. This should apply mutatis mutandis in the field of corporate taxation, if similar restrictions are provided for by the applicable national law. (67) Follow-up and feedback should take place within a reasonable timeframe, given the need to promptly address the problem that is the subject of the report, as well as the need to avoid unnecessary public disclosures. Such timeframe should not exceed three months, but could be extended to six months where necessary due to the specific circumstances of the case, in particular the nature and complexity of the subject of the report, which may require a lengthy investigation. (68) Union law in specific areas, such as market abuse, namely Regulation (EU) No 596/2014 and Implementing Directive (EU) 2015/2392, civil aviation, namely Regulation (EU) No 376/2014, or safety of offshore oil and gas operations, namely Directive 2013/30/EU, already provides for the establishment of internal and external reporting channels. The obligations to establish such channels laid down in this Directive should build as far as possible on the existing channels provided by specific Union acts. (69) The Commission, as well as some bodies, offices and agencies of the Union, such as the European Anti-Fraud Office (OLAF), the European Maritime Safety Agency (EMSA), the European Aviation Safety Agency (EASA), the European Security and Markets Authority (ESMA) and the European Medicines Agency (EMA), have in place external reporting channels and procedures for receiving reports of breaches falling within the scope of this Directive, which mainly provide for confidentiality of the identity of the reporting persons. This Directive should not affect such external reporting channels and procedures, where they exist, but should ensure that persons reporting to institutions, bodies, offices or agencies of the Union benefit from common minimum standards of protection throughout the Union. (70) To ensure the effectiveness of the procedures for following up on reports and addressing breaches of the Union rules concerned, Member States should be able to take measures to alleviate burdens for competent authorities resulting from reports of minor breaches of provisions falling within the scope of this Directive, repetitive reports or reports of breaches of ancillary provisions, for instance provisions on documentation or notification obligations. Such measures could consist in allowing competent authorities, after due assessment of the matter, to decide that a reported breach is clearly minor and does not require further follow-up pursuant to this Directive, other than closure of the procedure. It should also be possible for Member States to allow competent authorities to close the procedure regarding repetitive reports which do not contain any meaningful new information adding to a past report in respect of which the relevant procedures were concluded, unless new legal or factual circumstances justify a different form of follow-up. Furthermore, Member States should be able to allow competent authorities to prioritise the treatment of reports of serious breaches or breaches of essential provisions falling within the scope of this Directive in the event of high inflows of reports. (71) Where provided for under Union or national law, the competent authorities should refer cases or relevant information on breaches to institutions, bodies, offices or agencies of the Union, including, for the purposes of this Directive, OLAF and the European Public Prosecutor Office (EPPO), without prejudice to the possibility for the reporting person to refer directly to such bodies, offices or agencies of the Union. (72) In many policy areas falling within the material scope of this Directive, there are cooperation mechanisms through which national competent authorities exchange information and carry out follow-up activities in relation to breaches of Union rules with a cross-border dimension. Examples range from the Administrative Assistance and Cooperation System established by Commission Implementing Decision (EU) 2015/1918 (36), in cases of cross-border breaches of the Union agri-food chain legislation, and the Food Fraud Network under Regulation (EC) No 882/2004 of the European Parliament and of the Council (37), the rapid alert system for dangerous non-food products established by Regulation (EC) No 178/2002 of the European Parliament and of the Council (38), the Consumer Protection Cooperation Network under Regulation (EC) No 2006/2004 of the European Parliament and of the Council (39), to the Environmental Compliance and Governance Forum set up by the Commission Decision of 18 January 2018 (40), the European Competition Network established pursuant to Regulation (EC) No 1/2003, and the administrative cooperation in the field of taxation under Council Directive 2011/16/EU (41). Member States' competent authorities should make full use of such existing cooperation mechanisms where relevant as part of their obligation to follow up on reports regarding breaches falling within the scope of this Directive. In addition, Member States' authorities could also cooperate beyond the existing cooperation mechanisms in cases of breaches with a cross-border dimension in areas where such cooperation mechanisms do not exist. (73) In order to enable effective communication with staff members who are responsible for handling reports, it is necessary that the competent authorities have in place channels that are user-friendly, secure, ensure confidentiality for receiving and handling information provided by the reporting person on breaches, and that enable the durable storage of information to allow for further investigations. This could require that such channels are separated from the general channels through which the competent authorities communicate with the public, such as normal public complaints systems or channels through which the competent authority communicates internally and with third parties in its ordinary course of business. (74) Staff members of the competent authorities who are responsible for handling reports should be professionally trained, including on applicable data protection rules, in order to handle reports and to ensure communication with the reporting person, as well as to follow up on the report in a suitable manner. (75) Persons intending to report should be able to make an informed decision on whether, how and when to report. Competent authorities should therefore provide clear and easily accessible information about the available reporting channels with competent authorities, about the applicable procedures and about the staff members responsible for handling reports within those authorities. All information regarding reports should be transparent, easily understandable and reliable in order to promote and not deter reporting. (76) Member States should ensure that competent authorities have in place adequate protection procedures for the processing of reports and for the protection of the personal data of the persons referred to in the report. Such procedures should ensure that the identity of every reporting person, person concerned, and third persons referred to in the report, for example witnesses or colleagues, is protected at all stages of the procedure. (77) It is necessary that staff members of the competent authority who are responsible for handling reports and staff members of the competent authority who have the right of access to the information provided by a reporting person comply with the duty of professional secrecy and confidentiality when transmitting the data both inside and outside the competent authority, including where a competent authority opens an investigation or an internal enquiry or engages in enforcement activities in connection with the report. (78) The regular review of the procedures of competent authorities and the exchange of good practices between them should guarantee that those procedures are adequate and thus serving their purpose. (79) Persons making a public disclosure should qualify for protection in cases where, despite internal and external reporting, the breach remains unaddressed, for instance in cases where the breach was not appropriately assessed or investigated, or no appropriate remedial action was taken. The appropriateness of the follow-up should be assessed according to objective criteria, linked to the obligation of the competent authorities to assess the accuracy of the allegations and to put an end to any possible breach of Union law. The appropriateness of the follow-up will thus depend on the circumstances of each case and of the nature of the rules that have been breached. In particular, a decision by the authorities that a breach was clearly minor and no further follow-up, other than closure of the procedure, was required could constitute appropriate follow-up pursuant to this Directive. (80) Persons making a public disclosure directly should also qualify for protection in cases where they have reasonable grounds to believe that there is an imminent or manifest danger to the public interest, or a risk of irreversible damage, including harm to a person's physical integrity. (81) Persons making a public disclosure directly should also qualify for protection where they have reasonable grounds to believe that in the case of external reporting there is a risk of retaliation or there is a low prospect of the breach being effectively addressed, due to the particular circumstances of the case, such as those where evidence could be concealed or destroyed or where an authority could be in collusion with the perpetrator of the breach or involved in the breach. (82) Safeguarding the confidentiality of the identity of the reporting person during the reporting process and investigations triggered by the report is an essential ex-ante measure to prevent retaliation. It should only be possible to disclose the identity of the reporting person where that is a necessary and proportionate obligation under Union or national law in the context of investigations by authorities or judicial proceedings, in particular to safeguard the rights of defence of persons concerned. Such an obligation could derive, in particular, from Directive 2012/13/EU of the European Parliament and of the Council (42). The protection of confidentiality should not apply where the reporting person has intentionally revealed his or her identity in the context of a public disclosure. (83) Any processing of personal data carried out pursuant to this Directive, including the exchange or transmission of personal data by the competent authorities, should be undertaken in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (43) and with Directive (EU) 2016/680 of the European Parliament and of the Council (44). Any exchange or transmission of information by Union institutions, bodies, offices or agencies should be undertaken in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (45). Particular regard should be had to the principles relating to processing of personal data set out in Article 5 of Regulation (EU) 2016/679, Article 4 of Directive (EU) 2016/680 and Article 4 of Regulation (EU) 2018/1725, and to the principle of data protection by design and by default laid down in Article 25 of Regulation (EU) 2016/679, Article 20 of Directive (EU) 2016/680 and Articles 27 and 85 of Regulation (EU) 2018/1725. (84) The procedures provided for in this Directive and related to follow-up on reports of breaches of Union law in the areas falling within its scope serve an important objective of general public interest of the Union and of the Member States, within the meaning of point (e) of Article 23(1) of Regulation (EU) 2016/679, as they aim to enhance the enforcement of Union law and policies in specific areas where breaches can cause serious harm to the public interest. The effective protection of the confidentiality of the identity of reporting persons is necessary for the protection of the rights and freedoms of others, in particular those of the reporting persons, provided for under point (i) of Article 23(1) of Regulation (EU) 2016/679. Member States should ensure that this Directive is effective, including, where necessary, by restricting, by legislative measures, the exercise of certain data protection rights of persons concerned in line with points (e) and (i) of Article 23(1) and Article 23(2) of Regulation (EU) 2016/679 to the extent, and as long as, necessary to prevent and address attempts to hinder reporting or to impede, frustrate or slow down follow-up, in particular investigations, or attempts to find out the identity of the reporting persons. (85) The effective protection of the confidentiality of the identity of reporting persons is equally necessary for the protection of the rights and freedoms of others, in particular those of the reporting persons, where reports are handled by authorities as defined in point (7) of Article 3 of Directive (EU) 2016/680. Member States should ensure that this Directive is effective, including, where necessary, by restricting, by legislative measures, the exercise of certain data protection rights of persons concerned in line with points (a) and (e) of Article 13(3), points (a) and (e) of Article 15(1), points (a) and (e) of Article 16(4) and Article 31(5) of Directive (EU) 2016/680 to the extent, and as long as, necessary to prevent and address attempts to hinder reporting or to impede, frustrate or slow down follow-up, in particular investigations, or attempts to find out the identity of the reporting persons. (86) Member States should ensure that there is adequate record-keeping as regards all reports of breaches, that every report is retrievable and that information received through reports can be used as evidence in enforcement actions where appropriate. (87) Reporting persons should be protected against any form of retaliation, whether direct or indirect, taken, encouraged or tolerated by their employer or customer or recipient of services and by persons working for or acting on behalf of the latter, including colleagues and managers in the same organisation or in other organisations with which the reporting person is in contact in the context of his or her work-related activities (88) Where retaliation occurs undeterred and unpunished, it has a chilling effect on potential whistleblowers. A clear legal prohibition of retaliation would have an important dissuasive effect, and would be further strengthened by provisions for personal liability and penalties for the perpetrators of retaliation. (89) Potential whistleblowers who are not sure about how to report or whether they will be protected in the end may be discouraged from reporting. Member States should ensure that relevant and accurate information in that regard is provided in a way that is clear and easily accessible to the general public. Individual, impartial and confidential advice, free of charge, should be available on, for example, whether the information in question is covered by the applicable rules on whistleblower protection, which reporting channel might best be used and which alternative procedures are available in the event that the information is not covered by the applicable rules, so-called \u2018signposting\u2019. Access to such advice can help to ensure that reports are made through the appropriate channels, in a responsible manner, and that breaches are detected in a timely manner or even prevented. Such advice and information could be provided by an information centre or a single and independent administrative authority. Member States could choose to extend such advice to legal counselling. Where such advice is given to reporting persons by civil society organisations which are bound by a duty of maintaining the confidential nature of the information received, Member States should ensure that such organisations do not suffer retaliation, for instance in the form of economic prejudice through a restriction on their access to funding or blacklisting that could impede the proper functioning of the organisation. (90) Competent authorities should provide reporting persons with the support necessary for them to access protection effectively. In particular, they should provide proof or other documentation required to confirm to other authorities or courts that external reporting has taken place. Under certain national frameworks and in certain cases, reporting persons may benefit from forms of certification of the fact that they meet the conditions of the applicable rules. Notwithstanding such possibilities, they should have effective access to judicial review, whereby it is for the courts to decide, based on all the individual circumstances of the case, whether they meet the conditions of the applicable rules. (91) It should not be possible to rely on individuals' legal or contractual obligations, such as loyalty clauses in contracts or confidentiality or non-disclosure agreements, so as to preclude reporting, to deny protection or to penalise reporting persons for having reported information on breaches or made a public disclosure where providing the information falling within the scope of such clauses and agreements is necessary for revealing the breach. Where those conditions are met, reporting persons should not incur any kind of liability, be it civil, criminal, administrative or employment-related. It is appropriate that there be protection from liability for the reporting or public disclosure under this Directive of information in respect of which the reporting person had reasonable grounds to believe that reporting or public disclosure was necessary to reveal a breach pursuant to this Directive. Such protection should not extend to superfluous information that the person revealed without having such reasonable grounds. (92) Where reporting persons lawfully acquire or obtain access to the information on breaches reported or the documents containing that information, they should enjoy immunity from liability. This should apply both in cases where reporting persons reveal the content of documents to which they have lawful access as well as in cases where they make copies of such documents or remove them from the premises of the organisation where they are employed, in breach of contractual or other clauses stipulating that the relevant documents are the property of the organisation. The reporting persons should also enjoy immunity from liability in cases where the acquisition of or access to the relevant information or documents raises an issue of civil, administrative or labour-related liability. Examples would be cases where the reporting persons acquired the information by accessing the emails of a co-worker or files which they normally do not use within the scope of their work, by taking pictures of the premises of the organisation or by accessing locations they do not usually have access to. Where the reporting persons acquired or obtained access to the relevant information or documents by committing a criminal offence, such as physical trespassing or hacking, their criminal liability should remain governed by the applicable national law, without prejudice to the protection granted under Article 21(7) of this Directive. Similarly, any other possible liability of the reporting persons arising from acts or omissions which are unrelated to the reporting or are not necessary for revealing a breach pursuant to this Directive should remain governed by the applicable Union or national law. In those cases, it should be for the national courts to assess the liability of the reporting persons in the light of all relevant factual information and taking into account the individual circumstances of the case, including the necessity and proportionality of the act or omission in relation to the report or public disclosure. (93) Retaliation is likely to be presented as being justified on grounds other than the reporting and it can be very difficult for reporting persons to prove the link between the reporting and the retaliation, whilst the perpetrators of retaliation may have greater power and resources to document the action taken and the reasoning. Therefore, once the reporting person demonstrates prima facie that he or she reported breaches or made a public disclosure in accordance with this Directive and suffered a detriment, the burden of proof should shift to the person who took the detrimental action, who should then be required to demonstrate that the action taken was not linked in any way to the reporting or the public disclosure. (94) Beyond an explicit prohibition of retaliation provided in law, it is crucial that reporting persons who do suffer retaliation have access to legal remedies and compensation. The appropriate remedy in each case should be determined by the kind of retaliation suffered, and the damage caused in such cases should be compensated in full in accordance with national law. The appropriate remedy could take the form of actions for reinstatement, for instance, in the event of dismissal, transfer or demotion, or of withholding of training or promotion, or for restoration of a cancelled permit, licence or contract; compensation for actual and future financial losses, for example for lost past wages, but also for future loss of income, costs linked to a change of occupation; and compensation for other economic damage, such as legal expenses and costs of medical treatment, and for intangible damage such as pain and suffering. (95) While the types of legal action may vary between legal systems, they should ensure that compensation or reparation is real and effective, in a way which is proportionate to the detriment suffered and is dissuasive. Of relevance in this context are the Principles of the European Pillar of Social Rights, in particular Principle 7 according to which \u2018Prior to any dismissal, workers have the right to be informed of the reasons and be granted a reasonable period of notice. They have the right to access to effective and impartial dispute resolution and, in case of unjustified dismissal, a right to redress, including adequate compensation.\u2019. The remedies established at national level should not discourage potential future whistleblowers. For instance, providing for compensation as an alternative to reinstatement in the event of dismissal might give rise to a systematic practice, in particular by larger organisations, thus having a dissuasive effect on future whistleblowers. (96) Of particular importance for reporting persons are interim remedies pending the resolution of legal proceedings that can be protracted. Particularly, actions of interim relief, as provided for under national law, should also be available to reporting persons in order to stop threats, attempts or continuing acts of retaliation, such as harassment or to prevent forms of retaliation, such as dismissal, which might be difficult to reverse after the lapse of lengthy periods and which can ruin the individual financially, a perspective which can seriously discourage potential whistleblowers. (97) Action taken against reporting persons outside the work-related context, through proceedings, for instance, related to defamation, breach of copyright, trade secrets, confidentiality and personal data protection, can also pose a serious deterrent to whistleblowing. In such proceedings, reporting persons should be able to rely on having reported breaches or made a public disclosure in accordance with this Directive as a defence, provided that the information reported or publicly disclosed was necessary to reveal the breach. In such cases, the person initiating the proceedings should carry the burden of proving that the reporting person does not meet the conditions laid down by this Directive. (98) Directive (EU) 2016/943 of the European Parliament and of the Council (46) lays down rules to ensure a sufficient and consistent level of civil redress in the event of unlawful acquisition, use or disclosure of a trade secret. However, it also provides that the acquisition, use or disclosure of a trade secret is to be considered lawful to the extent that it is allowed by Union law. Persons who disclose trade secrets acquired in a work-related context should only benefit from the protection granted by this Directive, including in terms of not incurring civil liability, provided that they meet the conditions laid down by this Directive, including that the disclosure was necessary to reveal a breach falling within the material scope of this Directive. Where those conditions are met, disclosures of trade secrets are to be considered allowed by Union law within the meaning of Article 3(2) of Directive (EU) 2016/943. Moreover, both Directives should be considered as being complementary and the civil redress measures, procedures and remedies as well as exemptions provided for in Directive (EU) 2016/943 should remain applicable for all disclosures of trade secrets falling outside the scope of this Directive. Competent authorities that receive information on breaches that includes trade secrets should ensure that they are not used or disclosed for purposes going beyond what is necessary for proper follow-up of the reports. (99) A significant cost for reporting persons contesting retaliation measures taken against them in legal proceedings can be the relevant legal fees. Although they could recover such fees at the end of the proceedings, they might not be able to pay those fees if charged at the outset of proceedings, especially if they are unemployed and blacklisted. Assistance for criminal legal proceedings, particularly where the reporting persons meet the conditions of Directive (EU) 2016/1919 of the European Parliament and of the Council (47), and, more generally, support to those who are in serious financial need might be key, in certain cases, for the effective enforcement of their rights to protection. (100) The rights of the person concerned should be protected in order to avoid reputational damage or other negative consequences. Furthermore, the rights of defence and access to remedies of the person concerned should be fully respected at every stage of the procedure following the report, in accordance with Articles 47 and 48 of the Charter. Member States should protect the confidentiality of the identity of the person concerned and ensure the rights of defence including the right of access to the file, the right to be heard and the right to seek effective remedy against a decision concerning the person concerned under the applicable procedures set out in national law in the context of investigations or subsequent judicial proceedings. (101) Any person who suffers prejudice, whether directly or indirectly, as a consequence of the reporting or public disclosure of inaccurate or misleading information should retain the protection and the remedies available to him or her under the rules of general national law. Where such inaccurate or misleading information was reported or publicly disclosed deliberately and knowingly, the persons concerned should be entitled to compensation in accordance with national law. (102) Criminal, civil or administrative penalties are necessary to ensure the effectiveness of the rules on whistleblower protection. Penalties against those who take retaliatory or other adverse actions against reporting persons can discourage further such actions. Penalties against persons who report or publicly disclose information on breaches which is demonstrated to be knowingly false are also necessary to deter further malicious reporting and preserve the credibility of the system. The proportionality of such penalties should ensure that they do not have a dissuasive effect on potential whistleblowers. (103) Any decision taken by authorities adversely affecting the rights granted by this Directive, in particular decisions by which competent authorities decide to close the procedure regarding a reported breach on account of it being clearly minor or on account of the report being repetitive, or decide that a particular report does not deserve priority treatment, is subject to judicial review in accordance with Article 47 of the Charter. (104) This Directive introduces minimum standards and it should be possible for Member States to introduce or maintain provisions which are more favourable to the reporting person, provided that such provisions do not interfere with the measures for the protection of persons concerned. The transposition of this Directive should, under no circumstances, provide grounds for reducing the level of protection already granted to reporting persons under national law in the areas to which it applies. (105) In accordance with Article 26(2) TFEU, the internal market needs to comprise an area without internal frontiers in which the free movement of goods and services is ensured. The internal market should provide Union citizens with added value in the form of better quality and safety of goods and services, ensuring high standards of public health and environmental protection as well as free movement of personal data. Thus, Article 114 TFEU is the appropriate legal basis to adopt the measures necessary for the establishment and functioning of the internal market. In addition to Article 114 TFEU, this Directive should have additional specific legal bases in order to cover the fields that rely on Article 16, Article 43(2), Article 50, Article 53(1), Articles 91 and 100, Article 168(4), Article 169, Article 192(1) and Article 325(4) TFEU and Article 31 of the Euratom Treaty for the adoption of Union measures. (106) The material scope of this Directive is based on the identification of areas where the introduction of whistleblower protection appears justified and necessary on the basis of currently available evidence. Such material scope could be extended to further areas or Union acts, if that proves necessary as a means of strengthening their enforcement in the light of evidence that may come to the fore in the future, or on the basis of the evaluation of the way in which this Directive has functioned. (107) Where future legislative acts relevant to the policy areas covered by this Directive are adopted, they should specify, where appropriate, that this Directive applies. Where necessary, the material scope of this Directive should be adapted and the Annex should be amended accordingly. (108) Since the objective of this Directive, namely to strengthen enforcement in certain policy areas and as regards acts where breaches of Union law can cause serious harm to the public interest, through effective whistleblower protection, cannot be sufficiently achieved by the Member States acting alone or in an uncoordinated manner, but can rather be better achieved at Union level by laying down common minimum standards for whistleblower protection, and given that only Union action can provide coherence and align the existing Union rules on whistleblower protection, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (109) This Directive respects fundamental rights and the principles recognised in particular by the Charter, in particular Article 11 thereof. Accordingly, it is essential that this Directive be implemented in accordance with those rights and principles by ensuring full respect for, inter alia, freedom of expression and information, the right to protection of personal data, the freedom to conduct a business, the right to a high level of consumer protection, the right to a high level of human health protection, the right to a high level of environmental protection, the right to good administration, the right to an effective remedy and the rights of defence. (110) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I SCOPE, DEFINITIONS AND CONDITIONS FOR PROTECTION Article 1 Purpose The purpose of this Directive is to enhance the enforcement of Union law and policies in specific areas by laying down common minimum standards providing for a high level of protection of persons reporting breaches of Union law. Article 2 Material scope 1. This Directive lays down common minimum standards for the protection of persons reporting the following breaches of Union law: (a) breaches falling within the scope of the Union acts set out in the Annex that concern the following areas: (i) public procurement; (ii) financial services, products and markets, and prevention of money laundering and terrorist financing; (iii) product safety and compliance; (iv) transport safety; (v) protection of the environment; (vi) radiation protection and nuclear safety; (vii) food and feed safety, animal health and welfare; (viii) public health; (ix) consumer protection; (x) protection of privacy and personal data, and security of network and information systems; (b) breaches affecting the financial interests of the Union as referred to in Article 325 TFEU and as further specified in relevant Union measures; (c) breaches relating to the internal market, as referred to in Article 26(2) TFEU, including breaches of Union competition and State aid rules, as well as breaches relating to the internal market in relation to acts which breach the rules of corporate tax or to arrangements the purpose of which is to obtain a tax advantage that defeats the object or purpose of the applicable corporate tax law. 2. This Directive is without prejudice to the power of Member States to extend protection under national law as regards areas or acts not covered by paragraph 1. Article 3 Relationship with other Union acts and national provisions 1. Where specific rules on the reporting of breaches are provided for in the sector-specific Union acts listed in Part II of the Annex, those rules shall apply. The provisions of this Directive shall be applicable to the extent that a matter is not mandatorily regulated in those sector-specific Union acts. 2. This Directive shall not affect the responsibility of Member States to ensure national security or their power to protect their essential security interests. In particular, it shall not apply to reports of breaches of the procurement rules involving defence or security aspects unless they are covered by the relevant acts of the Union. 3. This Directive shall not affect the application of Union or national law relating to any of the following: (a) the protection of classified information; (b) the protection of legal and medical professional privilege; (c) the secrecy of judicial deliberations; (d) rules on criminal procedure. 4. This Directive shall not affect national rules on the exercise by workers of their rights to consult their representatives or trade unions, and on protection against any unjustified detrimental measure prompted by such consultations as well as on the autonomy of the social partners and their right to enter into collective agreements. This is without prejudice to the level of protection granted by this Directive. Article 4 Personal scope 1. This Directive shall apply to reporting persons working in the private or public sector who acquired information on breaches in a work-related context including, at least, the following: (a) persons having the status of worker, within the meaning of Article 45(1) TFEU, including civil servants; (b) persons having self-employed status, within the meaning of Article 49 TFEU; (c) shareholders and persons belonging to the administrative, management or supervisory body of an undertaking, including non-executive members, as well as volunteers and paid or unpaid trainees; (d) any persons working under the supervision and direction of contractors, subcontractors and suppliers. 2. This Directive shall also apply to reporting persons where they report or publicly disclose information on breaches acquired in a work-based relationship which has since ended. 3. This Directive shall also apply to reporting persons whose work-based relationship is yet to begin in cases where information on breaches has been acquired during the recruitment process or other pre-contractual negotiations. 4. The measures for the protection of reporting persons set out in Chapter VI shall also apply, where relevant, to: (a) facilitators; (b) third persons who are connected with the reporting persons and who could suffer retaliation in a work-related context, such as colleagues or relatives of the reporting persons; and (c) legal entities that the reporting persons own, work for or are otherwise connected with in a work-related context. Article 5 Definitions For the purposes of this Directive, the following definitions apply: (1) \u2018breaches\u2019 means acts or omissions that: (i) are unlawful and relate to the Union acts and areas falling within the material scope referred to in Article 2; or (ii) defeat the object or the purpose of the rules in the Union acts and areas falling within the material scope referred to in Article 2; (2) \u2018information on breaches\u2019 means information, including reasonable suspicions, about actual or potential breaches, which occurred or are very likely to occur in the organisation in which the reporting person works or has worked or in another organisation with which the reporting person is or was in contact through his or her work, and about attempts to conceal such breaches; (3) \u2018report\u2019 or \u2018to report\u2019 means, the oral or written communication of information on breaches; (4) \u2018internal reporting\u2019 means the oral or written communication of information on breaches within a legal entity in the private or public sector; (5) \u2018external reporting\u2019 means the oral or written communication of information on breaches to the competent authorities; (6) \u2018public disclosure\u2019 or \u2018to publicly disclose\u2019 means the making of information on breaches available in the public domain; (7) \u2018reporting person\u2019 means a natural person who reports or publicly discloses information on breaches acquired in the context of his or her work-related activities; (8) \u2018facilitator\u2019 means a natural person who assists a reporting person in the reporting process in a work-related context, and whose assistance should be confidential; (9) \u2018work-related context\u2019 means current or past work activities in the public or private sector through which, irrespective of the nature of those activities, persons acquire information on breaches and within which those persons could suffer retaliation if they reported such information; (10) \u2018person concerned\u2019 means a natural or legal person who is referred to in the report or public disclosure as a person to whom the breach is attributed or with whom that person is associated; (11) \u2018retaliation\u2019 means any direct or indirect act or omission which occurs in a work-related context, is prompted by internal or external reporting or by public disclosure, and which causes or may cause unjustified detriment to the reporting person; (12) \u2018follow-up\u2019 means any action taken by the recipient of a report or any competent authority, to assess the accuracy of the allegations made in the report and, where relevant, to address the breach reported, including through actions such as an internal enquiry, an investigation, prosecution, an action for recovery of funds, or the closure of the procedure; (13) \u2018feedback\u2019 means the provision to the reporting person of information on the action envisaged or taken as follow-up and on the grounds for such follow-up; (14) \u2018competent authority\u2019 means any national authority designated to receive reports in accordance with Chapter III and give feedback to the reporting person, and/or designated to carry out the duties provided for in this Directive, in particular as regards follow-up. Article 6 Conditions for protection of reporting persons 1. Reporting persons shall qualify for protection under this Directive provided that: (a) they had reasonable grounds to believe that the information on breaches reported was true at the time of reporting and that such information fell within the scope of this Directive; and (b) they reported either internally in accordance with Article 7 or externally in accordance with Article 10, or made a public disclosure in accordance with Article 15. 2. Without prejudice to existing obligations to provide for anonymous reporting by virtue of Union law, this Directive does not affect the power of Member States to decide whether legal entities in the private or public sector and competent authorities are required to accept and follow up on anonymous reports of breaches. 3. Persons who reported or publicly disclosed information on breaches anonymously, but who are subsequently identified and suffer retaliation, shall nonetheless qualify for the protection provided for under Chapter VI, provided that they meet the conditions laid down in paragraph 1. 4. Persons reporting to relevant institutions, bodies, offices or agencies of the Union breaches falling within the scope of this Directive shall qualify for protection as laid down in this Directive under the same conditions as persons who report externally. CHAPTER II INTERNAL REPORTING AND FOLLOW-UP Article 7 Reporting through internal reporting channels 1. As a general principle and without prejudice to Articles 10 and 15, information on breaches may be reported through the internal reporting channels and procedures provided for in this Chapter. 2. Member States shall encourage reporting through internal reporting channels before reporting through external reporting channels, where the breach can be addressed effectively internally and where the reporting person considers that there is no risk of retaliation. 3. Appropriate information relating to the use of internal reporting channels referred to in paragraph 2 shall be provided in the context of the information given by legal entities in the private and public sector pursuant to point (g) of Article 9(1), and by competent authorities pursuant to point (a) of Article 12(4) and Article 13. Article 8 Obligation to establish internal reporting channels 1. Member States shall ensure that legal entities in the private and public sector establish channels and procedures for internal reporting and for follow-up, following consultation and in agreement with the social partners where provided for by national law. 2. The channels and procedures referred to in paragraph 1 of this Article shall enable the entity's workers to report information on breaches. They may enable other persons, referred to in points (b), (c) and (d) of Article 4(1) and Article 4(2), who are in contact with the entity in the context of their work-related activities to also report information on breaches. 3. Paragraph 1 shall apply to legal entities in the private sector with 50 or more workers. 4. The threshold laid down in paragraph 3 shall not apply to the entities falling within the scope of Union acts referred to in Parts I.B and II of the Annex. 5. Reporting channels may be operated internally by a person or department designated for that purpose or provided externally by a third party. The safeguards and requirements referred to in Article 9(1) shall also apply to entrusted third parties operating the reporting channel for a legal entity in the private sector. 6. Legal entities in the private sector with 50 to 249 workers may share resources as regards the receipt of reports and any investigation to be carried out. This shall be without prejudice to the obligations imposed upon such entities by this Directive to maintain confidentiality, to give feedback, and to address the reported breach. 7. Following an appropriate risk assessment taking into account the nature of the activities of the entities and the ensuing level of risk for, in particular, the environment and public health, Member States may require legal entities in the private sector with fewer than 50 workers to establish internal reporting channels and procedures in accordance with Chapter II. 8. Member States shall notify the Commission of any decision they take to require legal entities in the private sector to establish internal reporting channels pursuant to paragraph 7. That notification shall include the reasons for the decision and the criteria used in the risk assessment referred to in paragraph 7. The Commission shall communicate that decision to the other Member States. 9. Paragraph 1 shall apply to all legal entities in the public sector, including any entity owned or controlled by such entities. Member States may exempt from the obligation referred to in paragraph 1 municipalities with fewer than 10 000 inhabitants or fewer than 50 workers, or other entities referred to in the first subparagraph of this paragraph with fewer than 50 workers. Member States may provide that internal reporting channels can be shared between municipalities or operated by joint municipal authorities in accordance with national law, provided that the shared internal reporting channels are distinct from and autonomous in relation to the relevant external reporting channels. Article 9 Procedures for internal reporting and follow-up 1. The procedures for internal reporting and for follow-up as referred to in Article 8 shall include the following: (a) channels for receiving the reports which are designed, established and operated in a secure manner that ensures that the confidentiality of the identity of the reporting person and any third party mentioned in the report is protected, and prevents access thereto by non-authorised staff members; (b) acknowledgment of receipt of the report to the reporting person within seven days of that receipt; (c) the designation of an impartial person or department competent for following-up on the reports which may be the same person or department as the one that receives the reports and which will maintain communication with the reporting person and, where necessary, ask for further information from and provide feedback to that reporting person; (d) diligent follow-up by the designated person or department referred to in point (c); (e) diligent follow-up, where provided for in national law, as regards anonymous reporting; (f) a reasonable timeframe to provide feedback, not exceeding three months from the acknowledgment of receipt or, if no acknowledgement was sent to the reporting person, three months from the expiry of the seven-day period after the report was made; (g) provision of clear and easily accessible information regarding the procedures for reporting externally to competent authorities pursuant to Article 10 and, where relevant, to institutions, bodies, offices or agencies of the Union. 2. The channels provided for in point (a) of paragraph 1 shall enable reporting in writing or orally, or both. Oral reporting shall be possible by telephone or through other voice messaging systems, and, upon request by the reporting person, by means of a physical meeting within a reasonable timeframe. CHAPTER III EXTERNAL REPORTING AND FOLLOW-UP Article 10 Reporting through external reporting channels Without prejudice to point (b) of Article 15(1), reporting persons shall report information on breaches using the channels and procedures referred to in Articles 11 and 12, after having first reported through internal reporting channels, or by directly reporting through external reporting channels. Article 11 Obligation to establish external reporting channels and to follow up on reports 1. Member States shall designate the authorities competent to receive, give feedback and follow up on reports, and shall provide them with adequate resources. 2. Member States shall ensure that the competent authorities: (a) establish independent and autonomous external reporting channels, for receiving and handling information on breaches; (b) promptly, and in any event within seven days of receipt of the report, acknowledge that receipt unless the reporting person explicitly requested otherwise or the competent authority reasonably believes that acknowledging receipt of the report would jeopardise the protection of the reporting person's identity; (c) diligently follow up on the reports; (d) provide feedback to the reporting person within a reasonable timeframe not exceeding three months, or six months in duly justified cases; (e) communicate to the reporting person the final outcome of investigations triggered by the report, in accordance with procedures provided for under national law; (f) transmit in due time the information contained in the report to competent institutions, bodies, offices or agencies of the Union, as appropriate, for further investigation, where provided for under Union or national law. 3. Member States may provide that competent authorities, after having duly assessed the matter, can decide that a reported breach is clearly minor and does not require further follow-up pursuant to this Directive, other than closure of the procedure. This shall not affect other obligations or other applicable procedures to address the reported breach, or the protection granted by this Directive in relation to internal or external reporting. In such a case, the competent authorities shall notify the reporting person of their decision and the reasons therefor. 4. Member States may provide that competent authorities can decide to close procedures regarding repetitive reports which do not contain any meaningful new information on breaches compared to a past report in respect of which the relevant procedures were concluded, unless new legal or factual circumstances justify a different follow-up. In such a case, the competent authorities shall notify the reporting person of their decision and the reasons therefor. 5. Member States may provide that, in the event of high inflows of reports, competent authorities may deal with reports of serious breaches or breaches of essential provisions falling within the scope of this Directive as a matter of priority, without prejudice to the timeframe as set out in point (d) of paragraph 2. 6. Member States shall ensure that any authority which has received a report but does not have the competence to address the breach reported transmits it to the competent authority, within a reasonable time, in a secure manner, and that the reporting person is informed, without delay, of such a transmission. Article 12 Design of external reporting channels 1. External reporting channels shall be considered independent and autonomous, if they meet all of the following criteria: (a) they are designed, established and operated in a manner that ensures the completeness, integrity and confidentiality of the information and prevents access thereto by non-authorised staff members of the competent authority; (b) they enable the durable storage of information in accordance with Article 18 to allow further investigations to be carried out. 2. The external reporting channels shall enable reporting in writing and orally. Oral reporting shall be possible by telephone or through other voice messaging systems and, upon request by the reporting person, by means of a physical meeting within a reasonable timeframe. 3. Competent authorities shall ensure that, where a report is received through channels other than the reporting channels referred to in paragraphs 1 and 2 or by staff members other than those responsible for handling reports, the staff members who receive it are prohibited from disclosing any information that might identify the reporting person or the person concerned, and that they promptly forward the report without modification to the staff members responsible for handling reports. 4. Member States shall ensure that competent authorities designate staff members responsible for handling reports, and in particular for: (a) providing any interested person with information on the procedures for reporting; (b) receiving and following up on reports; (c) maintaining contact with the reporting person for the purpose of providing feedback and requesting further information where necessary. 5. The staff members referred to in paragraph 4 shall receive specific training for the purposes of handling reports. Article 13 Information regarding the receipt of reports and their follow-up Member States shall ensure that competent authorities publish on their websites in a separate, easily identifiable and accessible section at least the following information: (a) the conditions for qualifying for protection under this Directive; (b) the contact details for the external reporting channels as provided for under Article 12, in particular the electronic and postal addresses, and the phone numbers for such channels, indicating whether the phone conversations are recorded; (c) the procedures applicable to the reporting of breaches, including the manner in which the competent authority may request the reporting person to clarify the information reported or to provide additional information, the timeframe for providing feedback and the type and content of such feedback; (d) the confidentiality regime applicable to reports, and in particular the information in relation to the processing of personal data in accordance with Article 17 of this Directive, Articles 5 and 13 of Regulation (EU) 2016/679, Article 13 of Directive (EU) 2016/680 and Article 15 of Regulation (EU) 2018/1725, as applicable; (e) the nature of the follow-up to be given to reports; (f) the remedies and procedures for protection against retaliation and the availability of confidential advice for persons contemplating reporting; (g) a statement clearly explaining the conditions under which persons reporting to the competent authority are protected from incurring liability for a breach of confidentiality pursuant to Article 21(2); and (h) contact details of the information centre or of the single independent administrative authority as provided for in Article 20(3) where applicable. Article 14 Review of the procedures by competent authorities Member States shall ensure that competent authorities review their procedures for receiving reports, and their follow-up, regularly, and at least once every three years. In reviewing such procedures, competent authorities shall take account of their experience as well as that of other competent authorities and adapt their procedures accordingly. CHAPTER IV PUBLIC DISCLOSURES Article 15 Public disclosures 1. A person who makes a public disclosure shall qualify for protection under this Directive if any of the following conditions is fulfilled: (a) the person first reported internally and externally, or directly externally in accordance with Chapters II and III, but no appropriate action was taken in response to the report within the timeframe referred to in point (f) of Article 9(1) or point (d) of Article 11(2); or (b) the person has reasonable grounds to believe that: (i) the breach may constitute an imminent or manifest danger to the public interest, such as where there is an emergency situation or a risk of irreversible damage; or (ii) in the case of external reporting, there is a risk of retaliation or there is a low prospect of the breach being effectively addressed, due to the particular circumstances of the case, such as those where evidence may be concealed or destroyed or where an authority may be in collusion with the perpetrator of the breach or involved in the breach. 2. This Article shall not apply to cases where a person directly discloses information to the press pursuant to specific national provisions establishing a system of protection relating to freedom of expression and information. CHAPTER V PROVISIONS APPLICABLE TO INTERNAL AND EXTERNAL REPORTING Article 16 Duty of confidentiality 1. Member States shall ensure that the identity of the reporting person is not disclosed to anyone beyond the authorised staff members competent to receive or follow up on reports, without the explicit consent of that person. This shall also apply to any other information from which the identity of the reporting person may be directly or indirectly deduced. 2. By way of derogation from paragraph 1, the identity of the reporting person and any other information referred to in paragraph 1 may be disclosed only where this is a necessary and proportionate obligation imposed by Union or national law in the context of investigations by national authorities or judicial proceedings, including with a view to safeguarding the rights of defence of the person concerned. 3. Disclosures made pursuant to the derogation provided for in paragraph 2 shall be subject to appropriate safeguards under the applicable Union and national rules. In particular, reporting persons shall be informed before their identity is disclosed, unless such information would jeopardise the related investigations or judicial proceedings. When informing the reporting persons, the competent authority shall send them an explanation in writing of the reasons for the disclosure of the confidential data concerned. 4. Member States shall ensure that competent authorities that receive information on breaches that includes trade secrets do not use or disclose those trade secrets for purposes going beyond what is necessary for proper follow-up. Article 17 Processing of personal data Any processing of personal data carried out pursuant to this Directive, including the exchange or transmission of personal data by the competent authorities, shall be carried out in accordance with Regulation (EU) 2016/679 and Directive (EU) 2016/680. Any exchange or transmission of information by Union institutions, bodies, offices or agencies shall be undertaken in accordance with Regulation (EU) 2018/1725. Personal data which are manifestly not relevant for the handling of a specific report shall not be collected or, if accidentally collected, shall be deleted without undue delay. Article 18 Record keeping of the reports 1. Member States shall ensure that legal entities in the private and public sector and competent authorities keep records of every report received, in compliance with the confidentiality requirements provided for in Article 16. Reports shall be stored for no longer than it is necessary and proportionate in order to comply with the requirements imposed by this Directive, or other requirements imposed by Union or national law. 2. Where a recorded telephone line or another recorded voice messaging system is used for reporting, subject to the consent of the reporting person, legal entities in the private and public sector and competent authorities shall have the right to document the oral reporting in one of the following ways: (a) by making a recording of the conversation in a durable and retrievable form; or (b) through a complete and accurate transcript of the conversation prepared by the staff members responsible for handling the report. Legal entities in the private and public sector and competent authorities shall offer the reporting person the opportunity to check, rectify and agree the transcript of the call by signing it. 3. Where an unrecorded telephone line or another unrecorded voice messaging system is used for reporting, legal entities in the private and public sector and competent authorities shall have the right to document the oral reporting in the form of accurate minutes of the conversation written by the staff member responsible for handling the report. Legal entities in the private and public sector and competent authorities shall offer the reporting person the opportunity to check, rectify and agree the minutes of the conversation by signing them. 4. Where a person requests a meeting with the staff members of legal entities in the private and public sector or of competent authorities for reporting purposes pursuant to Articles 9(2) and 12(2), legal entities in the private and public sector and competent authorities shall ensure, subject to the consent of the reporting person, that complete and accurate records of the meeting are kept in a durable and retrievable form. Legal entities in the private and public sector and competent authorities shall have the right to document the meeting in one of the following ways: (a) by making a recording of the conversation in a durable and retrievable form; or (b) through accurate minutes of the meeting prepared by the staff members responsible for handling the report. Legal entities in the private and public sector and competent authorities shall offer the reporting person the opportunity to check, rectify and agree the minutes of the meeting by signing them. CHAPTER VI PROTECTION MEASURES Article 19 Prohibition of retaliation Member States shall take the necessary measures to prohibit any form of retaliation against persons referred to in Article 4, including threats of retaliation and attempts of retaliation including in particular in the form of: (a) suspension, lay-off, dismissal or equivalent measures; (b) demotion or withholding of promotion; (c) transfer of duties, change of location of place of work, reduction in wages, change in working hours; (d) withholding of training; (e) a negative performance assessment or employment reference; (f) imposition or administering of any disciplinary measure, reprimand or other penalty, including a financial penalty; (g) coercion, intimidation, harassment or ostracism; (h) discrimination, disadvantageous or unfair treatment; (i) failure to convert a temporary employment contract into a permanent one, where the worker had legitimate expectations that he or she would be offered permanent employment; (j) failure to renew, or early termination of, a temporary employment contract; (k) harm, including to the person's reputation, particularly in social media, or financial loss, including loss of business and loss of income; (l) blacklisting on the basis of a sector or industry-wide informal or formal agreement, which may entail that the person will not, in the future, find employment in the sector or industry; (m) early termination or cancellation of a contract for goods or services; (n) cancellation of a licence or permit; (o) psychiatric or medical referrals. Article 20 Measures of support 1. Member States shall ensure that persons referred to in Article 4 have access, as appropriate, to support measures, in particular the following: (a) comprehensive and independent information and advice, which is easily accessible to the public and free of charge, on procedures and remedies available, on protection against retaliation, and on the rights of the person concerned; (b) effective assistance from competent authorities before any relevant authority involved in their protection against retaliation, including, where provided for under national law, certification of the fact that they qualify for protection under this Directive; and (c) legal aid in criminal and in cross-border civil proceedings in accordance with Directive (EU) 2016/1919 and Directive 2008/52/EC of the European Parliament and of the Council (48), and, in accordance with national law, legal aid in further proceedings and legal counselling or other legal assistance. 2. Member States may provide for financial assistance and support measures, including psychological support, for reporting persons in the framework of legal proceedings. 3. The support measures referred to in this Article may be provided, as appropriate, by an information centre or a single and clearly identified independent administrative authority. Article 21 Measures for protection against retaliation 1. Member States shall take the necessary measures to ensure that persons referred to in Article 4 are protected against retaliation. Such measures shall include, in particular, those set out in paragraphs 2 to 8 of this Article. 2. Without prejudice to Article 3(2) and (3), where persons report information on breaches or make a public disclosure in accordance with this Directive they shall not be considered to have breached any restriction on disclosure of information and shall not incur liability of any kind in respect of such a report or public disclosure provided that they had reasonable grounds to believe that the reporting or public disclosure of such information was necessary for revealing a breach pursuant to this Directive. 3. Reporting persons shall not incur liability in respect of the acquisition of or access to the information which is reported or publicly disclosed, provided that such acquisition or access did not constitute a self-standing criminal offence. In the event of the acquisition or access constituting a self-standing criminal offence, criminal liability shall continue to be governed by applicable national law. 4. Any other possible liability of reporting persons arising from acts or omissions which are unrelated to the reporting or public disclosure or which are not necessary for revealing a breach pursuant to this Directive shall continue to be governed by applicable Union or national law. 5. In proceedings before a court or other authority relating to a detriment suffered by the reporting person, and subject to that person establishing that he or she reported or made a public disclosure and suffered a detriment, it shall be presumed that the detriment was made in retaliation for the report or the public disclosure. In such cases, it shall be for the person who has taken the detrimental measure to prove that that measure was based on duly justified grounds. 6. Persons referred to in Article 4 shall have access to remedial measures against retaliation as appropriate, including interim relief pending the resolution of legal proceedings, in accordance with national law. 7. In legal proceedings, including for defamation, breach of copyright, breach of secrecy, breach of data protection rules, disclosure of trade secrets, or for compensation claims based on private, public, or on collective labour law, persons referred to in Article 4 shall not incur liability of any kind as a result of reports or public disclosures under this Directive. Those persons shall have the right to rely on that reporting or public disclosure to seek dismissal of the case, provided that they had reasonable grounds to believe that the reporting or public disclosure was necessary for revealing a breach, pursuant to this Directive. Where a person reports or publicly discloses information on breaches falling within the scope of this Directive, and that information includes trade secrets, and where that person meets the conditions of this Directive, such reporting or public disclosure shall be considered lawful under the conditions of Article 3(2) of the Directive (EU) 2016/943. 8. Member States shall take the necessary measures to ensure that remedies and full compensation are provided for damage suffered by persons referred to in Article 4 in accordance with national law. Article 22 Measures for the protection of persons concerned 1. Member States shall ensure, in accordance with the Charter, that persons concerned fully enjoy the right to an effective remedy and to a fair trial, as well as the presumption of innocence and the rights of defence, including the right to be heard and the right to access their file. 2. Competent authorities shall ensure, in accordance with national law, that the identity of persons concerned is protected for as long as investigations triggered by the report or the public disclosure are ongoing. 3. The rules set out in Articles 12, 17 and 18 as regards the protection of the identity of reporting persons shall also apply to the protection of the identity of persons concerned. Article 23 Penalties 1. Member States shall provide for effective, proportionate and dissuasive penalties applicable to natural or legal persons that: (a) hinder or attempt to hinder reporting; (b) retaliate against persons referred to in Article 4; (c) bring vexatious proceedings against persons referred to in Article 4; (d) breach the duty of maintaining the confidentiality of the identity of reporting persons, as referred to in Article 16. 2. Member States shall provide for effective, proportionate and dissuasive penalties applicable in respect of reporting persons where it is established that they knowingly reported or publicly disclosed false information. Member States shall also provide for measures for compensating damage resulting from such reporting or public disclosures in accordance with national law. Article 24 No waiver of rights and remedies Member States shall ensure that the rights and remedies provided for under this Directive cannot be waived or limited by any agreement, policy, form or condition of employment, including a pre-dispute arbitration agreement. CHAPTER VII FINAL PROVISIONS Article 25 More favourable treatment and non-regression clause 1. Member States may introduce or retain provisions more favourable to the rights of reporting persons than those set out in this Directive, without prejudice to Article 22 and Article 23(2). 2. The implementation of this Directive shall under no circumstances constitute grounds for a reduction in the level of protection already afforded by Member States in the areas covered by this Directive. Article 26 Transposition and transitional period 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 December 2021. 2. By way of derogation from paragraph 1, as regards legal entities in the private sector with 50 to 249 workers, Member States shall by 17 December 2023 bring into force the laws, regulations and administrative provisions necessary to comply with the obligation to establish internal reporting channels under Article 8(3). 3. When Member States adopt the provisions referred to in paragraphs 1 and 2, those provisions shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. They shall forthwith communicate to the Commission the text of those provisions. Article 27 Reporting, evaluation and review 1. Member States shall provide the Commission with all relevant information regarding the implementation and application of this Directive. On the basis of the information provided, the. Commission shall, by 17 December 2023, submit a report to the European Parliament and the Council on the implementation and application of this Directive. 2. Without prejudice to reporting obligations laid down in other Union legal acts, Member States shall, on an annual basis, submit the following statistics on the reports referred to in Chapter III to the Commission, preferably in an aggregated form, if they are available at a central level in the Member State concerned: (a) the number of reports received by the competent authorities; (b) the number of investigations and proceedings initiated as a result of such reports and their outcome; and (c) if ascertained, the estimated financial damage, and the amounts recovered following investigations and proceedings, related to the breaches reported. 3. The Commission shall, by 17 December 2025, taking into account its report submitted pursuant to paragraph 1 and the Member States' statistics submitted pursuant to paragraph 2, submit a report to the European Parliament and to the Council assessing the impact of national law transposing this Directive. The report shall evaluate the way in which this Directive has functioned and consider the need for additional measures, including, where appropriate, amendments with a view to extending the scope of this Directive to further Union acts or areas, in particular the improvement of the working environment to protect workers' health and safety and working conditions. In addition to the evaluation referred to in the first subparagraph, the report shall evaluate how Member States made use of existing cooperation mechanisms as part of their obligations to follow up on reports regarding breaches falling within the scope of this Directive and more generally how they cooperate in cases of breaches with a cross-border dimension. 4. The Commission shall make the reports referred to in paragraphs 1 and 3 public and easily accessible. Article 28 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 29 Addressees This Directive is addressed to the Member States. Done at Strasbourg, 23 October 2019. For the European Parliament The President D. M. SASSOLI For the Council The President T. TUPPURAINEN (1) OJ C 405, 9.11.2018, p. 1. (2) OJ C 62, 15.2.2019, p. 155. (3) Position of the European Parliament of 16 April 2019 (not yet published in the Official Journal) and decision of the Council of 7 October 2019. (4) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338). (5) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (6) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011(OJ L 169, 25.6.2019, p. 1). (7) Directive 2001/95/EC of the European Parliament and of the Council, of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). (8) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18). (9) Directive 2013/54/EU of the European Parliament and of the Council of 20 November 2013 concerning certain flag State responsibilities for compliance with and enforcement of the Maritime Labour Convention, 2006 (OJ L 329, 10.12.2013, p. 1). (10) Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (OJ L 131, 28.5.2009, p. 57). (11) Directive 2013/30/EU of the European Parliament and of the Council of 12 June 2013, on safety of offshore oil and gas operations and amending Directive 2004/35/EC (OJ L 178, 28.6.2013, p. 66). (12) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p. 18). (13) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (14) Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (\u2018Animal Health Law\u2019) (OJ L 84, 31.3.2016, p. 1). (15) Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23). (16) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33). (17) Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1). (18) Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, p. 1). (19) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). (20) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (21) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (22) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (23) OJ C 316, 27.11.1995, p. 49. (24) OJ C 313, 23.10.1996, p. 2. (25) OJ C 151, 20.5.1997, p. 2. (26) OJ C 221, 19.7.1997, p. 2. (27) Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles 81 and 82 of the EC Treaty (OJ L 123, 27.4.2004, p. 18). (28) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1). (29) Commission Implementing Directive (EU) 2015/2392 of 17 December 2015 on Regulation (EU) No 596/2014 of the European Parliament and of the Council as regards reporting to competent authorities of actual or potential infringements of that Regulation (OJ L 332, 18.12.2015, p. 126). (30) Regulation (EU) No 1286/2014 of the European Parliament and of the Council of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (OJ L 352, 9.12.2014, p. 1). (31) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1). (32) OJ L 56, 4.3.1968, p. 1. (33) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). (34) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (35) Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (OJ L 1, 4.1.2003, p. 1). (36) Commission Implementing Decision (EU) 2015/1918 of 22 October 2015 establishing the Administrative Assistance and Cooperation system (\u2018AAC system\u2019) pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 280, 24.10.2015, p. 31). (37) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). (38) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (39) Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (the Regulation on consumer protection cooperation) (OJ L 364, 9.12.2004, p. 1). (40) Commission Decision of 18 January 2018 setting up a group of experts on environmental compliance and governance (OJ C 19, 19.1.2018, p. 3). (41) Council Directive 2011/16/EU of 15 February 2011 on administrative cooperation in the field of taxation and repealing Directive 77/799/EEC (OJ L 64, 11.3.2011, p. 1). (42) Directive 2012/13/EU of the European Parliament and of the Council of 22 May 2012 on the right to information in criminal proceedings (OJ L 142, 1.6.2012, p. 1). (43) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (44) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (45) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (46) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1). (47) Directive (EU) 2016/1919 of the European Parliament and of the Council of 26 October 2016 on legal aid for suspects and accused persons in criminal proceedings and for requested persons in European arrest warrant proceedings (OJ L 297, 4.11.2016, p. 1). (48) Directive 2008/52/EC of the European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters (OJ L 136, 24.5.2008, p. 3). ANNEX Part I A. Point (a)(i) of Article 2(1) \u2014 public procurement: 1. Rules of procedure for public procurement and the award of concessions, for the award of contracts in the fields of defence and security, and for the award of contracts by entities operating in the fields of water, energy, transport and postal services and any other contract, as set out in: (i) Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (OJ L 94, 28.3.2014, p. 1); (ii) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65); (iii) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243); (iv) Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (OJ L 216, 20.8.2009, p. 76). 2. Review procedures regulated by: (i) Council Directive 92/13/EEC of 25 February 1992 coordinating the laws, regulations and administrative provisions relating to the application of Community rules on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors (OJ L 76, 23.3.1992, p. 14); (ii) Council Directive 89/665/EEC of 21 December 1989 on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contracts (OJ L 395, 30.12.1989, p. 33). B. Point (a)(ii) of Article 2(1) \u2014 financial services, products and markets, and prevention of money laundering and terrorist financing: Rules establishing a regulatory and supervisory framework and consumer and investor protection in the Union's financial services and capital markets, banking, credit, investment, insurance and re-insurance, occupational or personal pensions products, securities, investment funds, payment services and the activities listed in Annex I to Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338), as set out in: (i) Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (OJ L 267, 10.10.2009, p. 7); (ii) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1); (iii) Regulation (EU) No 236/2012 of the European Parliament and of the Council of 14 March 2012 on short selling and certain aspects of credit default swaps (OJ L 86, 24.3.2012, p. 1); (iv) Regulation (EU) No 345/2013 of the European Parliament and of the Council of 17 April 2013 on European venture capital funds (OJ L 115, 25.4.2013, p. 1); (v) Regulation (EU) No 346/2013 of the European Parliament and of the Council of 17 April 2013 on European social entrepreneurship fund (OJ L 115, 25.4.2013, p. 18); (vi) Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34); (vii) Regulation (EU) No 537/2014 of the European Parliament and of the Council of 16 April 2014 on specific requirements regarding statutory audit of public-interest entities and repealing Commission Decision 2005/909/EC (OJ L 158, 27.5.2014, p. 77); (viii) Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84); (ix) Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35); (x) Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (OJ L 142, 30.4.2004, p. 12); (xi) Directive 2007/36/EC of the European Parliament and of the Council of 11 July 2007 on the exercise of certain rights of shareholders in listed companies (OJ L 184, 14.7.2007, p. 17); (xii) Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (OJ L 390, 31.12.2004, p. 38); (xiii) Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1); (xiv) Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (OJ L 171, 29.6.2016, p. 1); (xv) Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1); (xvi) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190); (xvii) Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate and amending Council Directives 73/239/EEC, 79/267/EEC, 92/49/EEC, 92/96/EEC, 93/6/EEC and 93/22/EEC, and Directives 98/78/EC and 2000/12/EC of the European Parliament and of the Council (OJ L 35, 11.2.2003, p. 1); (xviii) Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee schemes (OJ L 173, 12.6.2014, p. 149); (xix) Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes (OJ L 84, 26.3.1997, p. 22); (xx) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). C. Point (a)(iii) of Article 2(1) \u2014 product safety and compliance: 1. Safety and compliance requirements for products placed in the Union market, as defined and regulated by: (i) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4); (ii) Union harmonisation legislation concerning manufactured products, including labelling requirements, other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction as listed in Annexes I and II to Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1); (iii) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p. 1). 2. Rules on marketing and use of sensitive and dangerous products, as set out in: (i) Directive 2009/43/EC of the European Parliament and of the Council of 6 May 2009 simplifying terms and conditions of transfers of defence-related products within the Community (OJ L 146, 10.6.2009, p. 1); (ii) Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons (OJ L 256, 13.9.1991, p. 51); (iii) Regulation (EU) No 98/2013 of the European Parliament and the Council of 15 January 2013 on the marketing and use of explosives precursors (OJ L 39, 9.2.2013, p. 1). D. Point (a)(iv) of Article 2(1) \u2014 transport safety: 1. Safety requirements in the railway sector, as regulated by Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, p. 102). 2. Safety requirements in the civil aviation sector, as regulated by Regulation (EU) No 996/2010 of the European Parliament and of the Council of 20 October 2010 on the investigation and prevention of accidents and incidents in civil aviation and repealing Directive 94/56/EC (OJ L 295, 12.11.2010, p. 35). 3. Safety requirements in the road sector, as regulated by: (i) Directive 2008/96/EC of the European Parliament and of the Council of 19 November 2008 on road infrastructure safety management (OJ L 319, 29.11.2008, p. 59); (ii) Directive 2004/54/EC of the European Parliament and of the Council of 29 April 2004 on minimum safety requirements for tunnels in the Trans-European Road Network (OJ L 167, 30.4.2004, p. 39); (iii) Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC (OJ L 300, 14.11.2009, p. 51). 4. Safety requirements in the maritime sector, as regulated by: (i) Regulation (EC) No 391/2009 of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations (OJ L 131, 28.5.2009, p. 11); (ii) Regulation (EC) No 392/2009 of the European Parliament and of the Council of 23 April 2009 on the liability of carriers of passengers by sea in the event of accidents (OJ L 131, 28.5.2009, p. 24); (iii) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146); (iv) Directive 2009/18/EC of the European Parliament and of the Council of 23 April 2009 establishing the fundamental principles governing the investigation of accidents in the maritime transport sector and amending Council Directive 1999/35/EC and Directive 2002/59/EC (OJ L 131, 28.5.2009, p. 114); (v) Directive 2008/106/EC of the European Parliament and of the Council of 19 November 2008 on the minimum level of training of seafarers (OJ L 323, 3.12.2008, p. 33); (vi) Council Directive 98/41/EC of 18 June 1998 on the registration of persons sailing on board passenger ships operating to or from ports of the Member States of the Community (OJ L 188, 2.7.1998, p. 35); (vii) Directive 2001/96/EC of the European Parliament and of the Council of 4 December 2001 establishing harmonised requirements and procedures for the safe loading and unloading of bulk carriers (OJ L 13, 16.1.2002, p. 9). 5. Safety requirements, as regulated by Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13). E. Point (a)(v) of Article 2(1) \u2014 protection of the environment: 1. Any criminal offence against the protection of the environment as regulated by Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28) or any unlawful conduct infringing the legislation set out in the Annexes to Directive 2008/99/EC; 2. Rules on the environment and climate, as set out in: (i) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32); (ii) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, p. 16); (iii) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1); (iv) Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13); (v) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). 3. Rules on sustainable development and waste management, as set out in: (i) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3); (ii) Regulation (EU) No 1257/2013 of the European Parliament and of the Council of 20 November 2013 on ship recycling and amending Regulation (EC) No 1013/2006 and Directive 2009/16/EC (OJ L 330, 10.12.2013, p. 1); (iii) Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60). 4. Rules on marine, air and noise pollution, as set out in: (i) Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars (OJ L 12, 18.1.2000, p. 16); (ii) Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants (OJ L 309, 27.11.2001, p. 22); (iii) Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (OJ L 189, 18.7.2002, p. 12); (iv) Regulation (EC) No 782/2003 of the European Parliament and of the Council of 14 April 2003 on the prohibition of organotin compounds on ships (OJ L 115, 9.5.2003, p. 1); (v) Directive 2004/35/EC of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (OJ L 143, 30.4.2004, p. 56); (vi) Directive 2005/35/EC of the European Parliament and of the Council of 7 September 2005 on ship-source pollution and on the introduction of penalties for infringements (OJ L 255, 30.9.2005, p. 11); (vii) Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ L 33, 4.2.2006, p. 1); (viii) Directive 2009/33/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of clean and energy-efficient road transport vehicles (OJ L 120, 15.5.2009, p. 5); (ix) Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emission performance standards for new passenger cars as part of the Community's integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 140, 5.6.2009, p. 1); (x) Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1); (xi) Directive 2009/126/EC of the European Parliament and of the Council of 21 October 2009 on Stage II petrol vapour recovery during refuelling of motor vehicles at service stations (OJ L 285, 31.10.2009, p. 36); (xii) Regulation (EU) No 510/2011 of the European Parliament and of the Council of 11 May 2011 setting emission performance standards for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 145, 31.5.2011, p. 1); (xiii) Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1); (xiv) Regulation (EU) 2015/757 of the European Parliament and of the Council of 29 April 2015 on the monitoring, reporting and verification of carbon dioxide emissions from maritime transport, and amending Directive 2009/16/EC (OJ L 123, 19.5.2015, p. 55); (xv) Directive (EU) 2015/2193 of the European Parliament and of the Council of 25 November 2015 on the limitation of emissions of certain pollutants into the air from medium combustion plants (OJ L 313, 28.11.2015, p. 1). 5. Rules on the protection and management of water and soil, as set out in: (i) Directive 2007/60/EC of the European Parliament and of the Council of 23 October 2007 on the assessment and management of flood risks (OJ L 288, 6.11.2007, p. 27); (ii) Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84); (iii) Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1). 6. Rules relating to the protection of nature and biodiversity, as set out in: (i) Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263, 3.10.2001, p. 1); (ii) Council Regulation (EC) No 812/2004 of 26 April 2004 laying down measures concerning bycatches of cetaceans in fisheries and amending Regulation (EC) No 88/98 (OJ L 150, 30.4.2004, p. 12); (iii) Regulation (EC) No 1007/2009 of the European Parliament and of the Council of 16 September 2009 on trade in seal products (OJ L 286, 31.10.2009, p. 36); (iv) Council Regulation (EC) No 734/2008 of 15 July 2008 on the protection of vulnerable marine ecosystems in the high seas from the adverse impacts of bottom fishing gears (OJ L 201, 30.7.2008, p. 8); (v) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7); (vi) Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market (OJ L 295, 12.11.2010, p. 23); (vii) Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35). 7. Rules on chemicals, as set out in Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 8. Rules relating to organic products, as set out in Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1). F. Point (a)(vi) of Article 2(1) \u2014 radiation protection and nuclear safety Rules on nuclear safety, as set out in: (i) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p. 18); (ii) Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (OJ L 296, 7.11.2013, p. 12); (iii) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1); (iv) Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste (OJ L 199, 2.8.2011, p. 48); (v) Council Directive 2006/117/Euratom of 20 November 2006 on the supervision and control of shipments of radioactive waste and spent fuel (OJ L 337, 5.12.2006, p. 21); (vi) Council Regulation (Euratom) 2016/52 of 15 January 2016 laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency, and repealing Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and (Euratom) No 770/90 (OJ L 13, 20.1.2016, p. 2); (vii) Council Regulation (Euratom) No 1493/93 of 8 June 1993 on shipments of radioactive substances between Member States (OJ L 148, 19.6.1993, p. 1). G. Point (a)(vii) of Article 2(1) \u2014 food and feed safety, animal health and animal welfare: 1. Union food and feed law governed by the general principles and requirements as defined by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). 2. Animal health, as regulated by: (i) Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (\u2018Animal Health Law\u2019) (OJ L 84, 31.3.2016, p. 1); (ii) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1). 3. Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1). 4. Rules and standards on the protection and well-being of animals, as set out in: (i) Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23); (ii) Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1); (iii) Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, p. 1); (iv) Council Directive 1999/22/EC of 29 March 1999 relating to the keeping of wild animals in zoos (OJ L 94, 9.4.1999, p. 24); (v) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33). H. Point (a) (viii) of Article 2(1) \u2014 public health: 1. Measures setting high standards of quality and safety of organs and substances of human origin, as regulated by: (i) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30); (ii) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48); (iii) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14). 2. Measures setting high standards of quality and safety for medicinal products and devices of medical use, as regulated by: (i) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1); (ii) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67); (iii) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43); (iv) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1); (v) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1); (vi) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121); (vii) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). 3. Patients' rights, as regulated by Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4. Manufacture, presentation and sale of tobacco and related products, as regulated by Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1). I. Point (a)(ix) of Article 2(1) \u2014 consumer protection: Consumer rights and consumer protection, as regulated by: (i) Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ L 80, 18.3.1998, p. 27); (ii) Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (OJ L 136, 22.5.2019, p. 1); (iii) Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, p. 28); (iv) Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, p. 12); (v) Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC (OJ L 271, 9.10.2002, p. 16); (vi) Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (\u2018Unfair Commercial Practices Directive\u2019) (OJ L 149, 11.6.2005, p. 22); (vii) Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66); (viii) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64); (ix) Directive 2014/92/EU of the European Parliament and of the Council of 23 July 2014 on the comparability of fees related to payment accounts, payment account switching and access to payment accounts with basic features (OJ L 257, 28.8.2014, p. 214). J. Point (a)(x) of Article 2(1) \u2014 protection of privacy and personal data, and security of network and information systems: (i) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37); (ii) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1); (iii) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). Part II Article 3(1) refers to the following Union legislation: A. Point (a)(ii) of Article 2(1) \u2014 financial services, products and markets, and prevention of money laundering and terrorist financing: 1. Financial services: (i) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32); (ii) Directive (EU) 2016/2341 of the European Parliament and of the Council of 14 December 2016 on the activities and supervision of institutions for occupational retirement provision (IORPs) (OJ L 354, 23.12.2016, p. 37); (iii) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87); (iv) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1); (v) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338); (vi) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349); (vii) Regulation (EU) No 909/2014 of the European Parliament and of the Council of 23 July 2014 on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012 (OJ L 257, 28.8.2014, p. 1); (viii) Regulation (EU) No 1286/2014 of the European Parliament and of the Council of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (OJ L 352, 9.12.2014, p. 1); (ix) Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, p. 1); (x) Directive (EU) 2016/97 of the European Parliament and of the Council of 20 January 2016 on insurance distribution (OJ L 26, 2.2.2016, p. 19); (xi) Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12). 2. Prevention of money laundering and terrorist financing: (i) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73); (ii) Regulation (EU) 2015/847 of the European Parliament and of the Council of 20 May 2015 on information accompanying transfers of funds and repealing Regulation (EC) No 1781/2006 (OJ L 141, 5.6.2015, p. 1). B. Point (a)(iv) of Article 2(1) \u2014 transport safety: (i) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18); (ii) Directive 2013/54/EU of the European Parliament and of the Council of 20 November 2013 concerning certain flag State responsibilities for compliance with and enforcement of the Maritime Labour Convention, 2006 (OJ L 329, 10.12.2013, p. 1); (iii) Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (OJ L 131, 28.5.2009, p. 57). C. Point (a)(v) of Article 2(1) \u2014 protection of the environment: (i) Directive 2013/30/EU of the European Parliament and of the Council of 12 June 2013 on safety of offshore oil and gas operations and amending Directive 2004/35/EC (OJ L 178, 28.6.2013, p. 66).", "summary": "Protection of persons who report breaches of EU law Protection of persons who report breaches of EU law SUMMARY OF: Directive (EU) 2019/1937 on the protection of persons who report breaches of EU law WHAT IS THE AIM OF THE DIRECTIVE? It establishes rules and procedures to protect \u2018whistleblowers\u2019, individuals who report* information they acquired in a work-related context on breaches* of EU law in key policy areas. Breaches include both unlawful acts or omissions and abusive practices. KEY POINTS The directive covers reports on: breaches of rules in the following areas (listed in detail in Part I of the annex) public procurementfinancial services, products and markets; prevention of money laundering and terrorist financingproduct safety and compliancetransport safety in the railway, road, maritime and inland waters sectorsprotection of the environment, ranging from waste management to chemicalsradiation protection and nuclear safetyfood and feed safety, animal health and welfarepublic health, including patients\u2019 rights and tobacco controlsconsumer protectionprotection of privacy and personal data, security and information systems; breaches affecting the EU\u2019s financial interests; breaches relating to the internal market, including breaches of EU competition and State aid rules, and breaches of national corporate tax rules. The directive complements specific EU legislation which already includes rules on whistleblowing (notably on financial services, money laundering, terrorist financing, transport safety and environmental protection). The directive does not: affect the responsibility of EU governments to protect their national security; affect EU or national law on protection of classified information, legal and medical professional privilege, secrecy of judicial proceedings or criminal procedural rule; override national rules on rights of employees to consult their representatives or trade unions. The legislation covers a wide range of people working in the private and public sectors, including those who report after their work-based relationship has ended: employees, self-employed people, shareholders, persons belonging to the administrative, management and supervisory bodies of businesses, volunteers, trainees and job applicants; persons who help whistleblowers in a confidential manner, persons connected to a whistleblower who might suffer retaliation* at work, and legal entities linked to the whistleblower. Individuals are protected if they go public with their concerns provided they: first reported (internally and) externally but no action was taken; reasonably believe that there is an imminent or clear danger to the public interest, a risk of retaliation or little likelihood of their concern being properly addressed. Reporting arrangements include: internal channels: all private companies with 50 or more employees and, in principle, all public entities must set up effective reporting channels, ensuring confidentiality; public entities with less than 50 employees and municipalities with fewer than 10,000 inhabitants may be exempted; external channels: appropriate national authorities must establish reporting channels enabling confidential reporting; follow-up procedures and deadlines for handling reports received through internal and external channels. These include a duty not to reveal the whistleblower\u2019s identity, except in strictly limited circumstancescompliance with EU data protection legislationrecords of every oral or written report received. Legal protection To qualify for legal protection, an individual must: have reasonable grounds to believe that the information they report is covered by the legislation and true at the time of reporting; report the breach to the competent authorities use the internal or external channels provided. Whistleblowers are encouraged to report internally (within the organisation) first, where the breach can be addressed effectively internally and where they consider that there is no risk of retaliation. However, they can choose whether to report first internally or to directly report externally to the competent authorities. Whistleblowers: are protected against all forms of retaliation, such as dismissal, demotion, intimidation and blacklisting; have access to appropriate support measures, notably independent information and advice and legal aid in accordance with EU rules on legal aid in criminal and cross-border civil proceedings; have access to appropriate remedial measures, such as interim relief and immunity from liability for breaching non-disclosure clauses in their contracts. EU countries must: ensure appropriate internal and external reporting channels are in place; take the necessary measures to prevent any retaliation against a whistleblower; respect the right to an effective remedy, a fair trial, presumption of innocence and rights of defence of persons concerned by the allegations in the reports; provide effective, proportionate and dissuasive penalties for breaches of certain rules of the directive, for instance for persons who hinder reporting or who retaliate against whistleblowers; transpose the directive and notify to the European Commission the transposition measures by 17 December 2021; with a possible exemption for transposing the provisions on the obligation of private companies with between 50 and 249 employees to set up their internal reporting channels until 17 December 2023; provide the Commission with annual data on numbers of reports received and investigations opened and their outcome, and the financial consequences. The Commission submits to the European Parliament and the Council: a first public and easily accessible report on the incorporation of the directive in EU countries\u2019 national law by 17 December 2023; and a second on the implementation of the directive and on possible amendments needed, by 17 December 2025. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 16 December 2019 and It has to become law in the EU countries by 17 December 2021. BACKGROUND For more information, see: Whistleblower protection: Commission sets new, EU-wide rules (European Commission). KEY TERMS Report: oral or written communication informing of a breach. Breach: act or omission that is unlawful or defeats the aim of the EU legislation. Retaliation: any direct or indirect behaviour at work which could harm the whistleblower. MAIN DOCUMENT Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, pp. 17-56) last update 20.05.2020"}
{"article": "14.11.2019 EN Official Journal of the European Union L 295/1 REGULATION (EU) 2019/1896 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2)(b) and (d) and Article 79(2)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The objective of Union policy in the field of external border management is to develop and implement European integrated border management at national and Union level, which is a necessary corollary to the free movement of persons within the Union and is a fundamental component of an area of freedom, security and justice. European integrated border management is central to improving migration management. The aim is to manage the crossing of the external borders efficiently and address migratory challenges and potential future threats at those borders, thereby contributing to addressing serious crime with a cross-border dimension and ensuring a high level of internal security within the Union. At the same time, it is necessary to act in full respect for fundamental rights and in a manner that safeguards the free movement of persons within the Union. (2) The European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union was established by Council Regulation (EC) No 2007/2004 (4). Since taking up its responsibilities on 1 May 2005, it has been successful in assisting Member States with implementing the operational aspects of external border management through joint operations and rapid border interventions, risk analysis, information exchange, relations with third countries and the return of returnees. (3) The European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union has been renamed the European Border and Coast Guard Agency (the \u2018Agency\u2019), commonly referred to as Frontex, and its tasks have been expanded with full continuity in all its activities and procedures. The key roles of the Agency should be: to establish a technical and operational strategy as part of the implementation of the multiannual strategic policy cycle for European integrated border management; to oversee the effective functioning of border control at the external borders; to carry out risk analysis and vulnerability assessments; to provide increased technical and operational assistance to Member States and third countries through joint operations and rapid border interventions; to ensure the practical execution of measures in a situation requiring urgent action at the external borders; to provide technical and operational assistance in the support of search and rescue operations for persons in distress at sea; and to organise, coordinate and conduct return operations and return interventions. (4) Since the beginning of the migratory crisis in 2015, the Commission has taken up important initiatives and has proposed a series of measures with a view to strengthening the protection of the external borders and restoring the normal functioning of the Schengen area. A proposal for significantly enhancing the mandate of the European Agency for the Management of Operational Cooperation at the External Borders was presented in December 2015 and negotiated swiftly in 2016. The resulting regulation, Regulation (EU) 2016/1624 of the European Parliament and of the Council (5), entered into force on 6 October 2016. (5) However, the Union framework in the areas of external border control, return, combating cross-border crime, and asylum still needs to be further improved. To that end, and to further underpin the current and future envisaged operational efforts, the European Border and Coast Guard should be reformed by giving the Agency a stronger mandate and, in particular, by providing it with the necessary capabilities in the form of a European Border and Coast Guard standing corps (the \u2018standing corps\u2019). The standing corps should gradually but swiftly reach the strategic target of having a capacity of 10 000 operational staff, as set out in Annex I, with executive powers, where applicable, to effectively support Member States on the ground in their efforts to protect the external borders, to fight cross-border crime and to significantly step up the effective and sustainable return of irregular migrants. Such a capacity of 10 000 operational staff represents the maximum available capacity required to effectively address existing and future operational needs for border and return operations in the Union and third countries, including a rapid reaction capacity to face future crises. (6) The Commission should carry out a review of the overall number and composition of the standing corps, including the size of individual Member States' contributions thereto, as well as of its training, expertise and professionalism. By March 2024, the Commission should, where necessary, submit appropriate proposals to amend Annexes I, II, III and IV. Where the Commission does not present a proposal, it should explain the reason therefor. (7) The implementation of this Regulation, in particular the establishment of the standing corps, including after the Commission's review of the standing corps, should be subject to the multiannual financial framework. (8) In its conclusions of 28 June 2018, the European Council called for further strengthening of the supportive role of the Agency, including in cooperation with third countries, through increased resources and an enhanced mandate, with a view to ensuring effective external border control and significantly stepping up the effective return of irregular migrants. (9) It is necessary to monitor the crossing of the external borders efficiently, to address migratory challenges and potential future threats at the external borders, to ensure a high level of internal security within the Union, to safeguard the functioning of the Schengen area and to respect the overarching principle of solidarity. Those actions and objectives should be accompanied by the proactive management of migration, including the necessary measures in third countries. To that end, it is necessary to consolidate the European Border and Coast Guard and to further expand the mandate of the Agency. (10) When implementing European integrated border management, coherence with other policy objectives should be ensured. (11) European integrated border management, based on the four-tier access control model, comprises measures in third countries, such as under the common visa policy, measures with neighbouring third countries, border control measures at the external borders, risk analysis and measures within the Schengen area and return. (12) European integrated border management should be implemented as a shared responsibility of the Agency and the national authorities responsible for border management, including coast guards to the extent that they carry out maritime border surveillance operations and any other border control tasks, as well as the national authorities responsible for return. While Member States retain the primary responsibility for the management of their external borders in their interest and in the interest of all Member States and are responsible for issuing return decisions, the Agency should support the application of Union measures relating to the management of the external borders and return by reinforcing, assessing and coordinating the actions of the Member States which implement those measures. The activities of the Agency should complement the efforts of the Member States. (13) To ensure the effective implementation of European integrated border management and increase the efficiency of Union return policy, a European Border and Coast Guard should be established. It should be provided with the requisite financial and human resources and equipment. The European Border and Coast Guard should be composed of the Agency and the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return. As such it will rely upon the common use of information, capabilities and systems at national level and the response of the Agency at Union level. (14) European integrated border management does not alter the respective competences of the Commission and the Member States in the customs area, in particular regarding controls, risk management and the exchange of information. (15) The development of policy and law on external border control and return, including the development of a multiannual strategic policy for European integrated border management, remains a responsibility of the Union institutions. Close coordination between the Agency and those institutions should be guaranteed. (16) The effective implementation of European integrated border management by the European Border and Coast Guard should be ensured by means of a multiannual strategic policy cycle. The multiannual cycle should set out an integrated, unified and continuous process for providing strategic guidelines to all the relevant actors at Union level and at national level in the area of border management and return so that those actors are able to implement European integrated border management in a coherent manner. It should also address all relevant interactions of the European Border and Coast Guard with the Commission and other Union institutions, bodies, offices and agencies, and cooperation with other relevant partners, including third countries and third parties as appropriate. (17) European integrated border management requires integrated planning between the Member States and the Agency for border and return operations in order to prepare responses to challenges at the external borders, for contingency planning and for coordinating the long-term development of capabilities both in terms of recruitment and training and in terms of the acquisition and development of equipment. (18) The Agency should develop technical standards for information exchange as provided for in this Regulation. In addition, for the effective implementation of Regulation (EU) 2016/399 of the European Parliament and of the Council (6), common minimum standards for external border surveillance should be developed. To that end, the Agency should be able to contribute to the development of common minimum standards in line with the respective competences of the Member States and the Commission. Those common minimum standards should be developed taking into account the type of borders, the impact levels attributed by the Agency to each external border section and other factors such as geographical particularities. When developing those common minimum standards, possible limitations deriving from national law should be taken into account. (19) The technical standards for information systems and software applications should be aligned with the standards used by the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) for other IT systems in the area of freedom, security and justice. (20) The implementation of this Regulation does not affect the division of competence between the Union and the Member States or the obligations of Member States under the United Nations Convention on the Law of the Sea, the International Convention for the Safety of Life at Sea, the International Convention on Maritime Search and Rescue, the United Nations Convention against Transnational Organized Crime and its Protocol against the Smuggling of Migrants by Land, Sea and Air, the 1951 Convention relating to the Status of Refugees, the 1967 Protocol thereto, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the United Nations Convention relating to the Status of Stateless Persons and other relevant international instruments. (21) The implementation of this Regulation does not affect Regulation (EU) No 656/2014 of the European Parliament and of the Council (7). Sea operations should be carried out in a way that, in all instances, ensures the safety of the persons intercepted or rescued, the safety of the units that take part in the sea operation in question and the safety of third parties. (22) The Agency should carry out its tasks in accordance with the principle of subsidiarity and without prejudice to the responsibilities of the Member States with regard to maintaining law and order and safeguarding internal security. (23) The Agency should carry out its tasks without prejudice to the competence of the Member States as regards defence. (24) The extended tasks and competence of the Agency should be balanced with strengthened fundamental rights safeguards and increased accountability and liability, in particular in terms of the exercise of executive powers by the statutory staff. (25) The Agency relies on the cooperation of Member States to be able to perform its tasks effectively. In that respect, it is important for the Agency and the Member States to act in good faith and to exchange accurate information in a timely manner. No Member State should be obliged to supply information the disclosure of which it considers contrary to the essential interests of its security. (26) Member States should also, in their own interest and in the interest of the other Member States, contribute relevant data necessary for the activities carried out by the Agency, including for the purposes of situational awareness, risk analysis, vulnerability assessments and integrated planning. Equally, they should ensure that the data are accurate and up-to-date and are obtained and entered lawfully. Where those data include personal data, Union law on data protection should apply in full. (27) The communication network established under this Regulation should be based on and replace the EUROSUR communication network developed in the framework of Regulation (EU) No 1052/2013 of the European Parliament and of the Council (8). The communication network established under this Regulation should be used for all secured information exchanges within the European Border and Coast Guard. The level of accreditation of the communication network should be increased to the classification level of CONFIDENTIEL UE/EU CONFIDENTIAL in order to improve information assurance between the Member States and with the Agency. (28) EUROSUR is necessary for the European Border and Coast Guard to be able to provide a framework for the exchange of information and the operational cooperation between Member States' national authorities and with the Agency. EUROSUR provides national authorities and the Agency with the infrastructure and tools needed to improve their situational awareness and to increase reaction capability at the external borders for the purpose of detecting, preventing and combating illegal immigration and cross-border crime, thereby contributing to saving the lives of migrants and ensuring their protection. (29) Member States should establish national coordination centres to improve the exchange of information and cooperation between Member States and with the Agency with respect to border surveillance and the carrying out of border checks. It is essential for the proper functioning of EUROSUR that all national authorities with a responsibility for external border surveillance under national law cooperate via national coordination centres. (30) The role of the national coordination centre to coordinate and exchange information among all authorities with a responsibility for external border control at national level is without prejudice to the competence established at national level with regard to planning and implementing border control. (31) This Regulation should not hinder Member States from also making their national coordination centres responsible for coordinating the exchange of information and for cooperation with regard to other components of European integrated border management. (32) The quality of the information exchanged between the Member States and the Agency and the timeliness of the exchange of such information are prerequisites for the proper functioning of European integrated border management. Building on the success of EUROSUR, that quality should be ensured through standardisation, the automation of the information exchange across networks and systems, information assurance and control of the quality of the data and information transmitted. (33) The Agency should provide the necessary assistance for the development and operation of EUROSUR, including the interoperability of systems, in particular by establishing, maintaining and coordinating EUROSUR. (34) EUROSUR should provide an exhaustive situational picture not only at the external borders but also within the Schengen area and in the pre-frontier area. It should cover land, sea and air border surveillance and border checks. The provision of situational awareness within the Schengen area should not lead to operational activities of the Agency at the internal borders of the Member States. (35) Air border surveillance should be an element of border management since both commercial and private flights and remotely piloted aircraft systems are used for illegal activities related to immigration and cross-border crime. Air border surveillance aims to detect and monitor such suspicious flights crossing or intending to cross the external borders and to perform related risk analysis with a view to triggering reaction capabilities by the competent authorities of the Union and the Member States. For that purpose, inter-agency cooperation at Union level should be promoted between the Agency, the Network Manager of the European Air Traffic Management Network (EATMN) and the European Union Aviation Safety Agency (EASA). Where relevant, Member States should be able to receive information on suspicious external flights and react accordingly. The Agency should monitor and support research and innovation activities in that area. (36) The reporting of events related to unauthorised secondary movements in EUROSUR will contribute to the monitoring by the Agency of migratory flows towards and within the Union for the purpose of risk analysis and situational awareness. The implementing act laying down the details of the information layers of the situational pictures and the rules for the establishment of specific situational pictures should further define the type of reporting to best meet this objective. (37) The EUROSUR fusion services supplied by the Agency should be based on the common application of surveillance tools and inter-agency cooperation at Union level, including the provision of Copernicus security services. EUROSUR fusion services should provide the Member States and the Agency with value-added information services related to European integrated border management. EUROSUR fusion services should be expanded to support border checks, air border surveillance and the monitoring of migration flows. (38) The practice of travelling in small and unseaworthy vessels has dramatically increased the number of migrants drowning at the southern maritime external borders. EUROSUR should considerably improve the operational and technical ability of the Agency and the Member States to detect such small vessels and to improve the reaction capability of the Member States, thereby contributing to reducing the loss of lives of migrants, including in the framework of search and rescue operations. (39) It is recognised in this Regulation that migratory routes are also taken by persons in need of international protection. (40) The Agency should prepare general and tailored risk analyses based on a common integrated risk analysis model, to be applied by the Agency itself and by Member States. The Agency should, based also on information provided by Member States, provide adequate information covering all aspects relevant to European integrated border management, especially border control, return, the phenomenon of unauthorised secondary movements of third-country nationals within the Union in terms of trends, volume and routes, prevention of cross-border crime including facilitation of unauthorised border crossings, trafficking in human beings, terrorism and threats of a hybrid nature, as well as the situation in relevant third countries, so as to allow for appropriate measures to be taken or to tackle identified threats and risks with a view to improving the integrated management of the external borders. (41) Given its activities at the external borders, the Agency should contribute to preventing and detecting cross-border crime, such as migrant smuggling, trafficking in human beings and terrorism, where it is appropriate for it to act and where it has obtained relevant information through its activities. It should coordinate its activities with Europol, which is the agency responsible for supporting and strengthening Member States' actions and their cooperation in preventing and combating serious crime affecting two or more Member States. The cross-border dimension is characterised by crimes that are directly linked to unauthorised crossings of the external borders, including trafficking in human beings or smuggling of migrants. In accordance with Council Directive 2002/90/EC (9), Member States are able to decide not to impose sanctions where the aim of the behaviour is to provide humanitarian assistance to migrants. (42) In a spirit of shared responsibility, the role of the Agency should be to monitor regularly the management of the external borders, including the respect for fundamental rights in the border management and return activities of the Agency. The Agency should ensure proper and effective monitoring not only through situational awareness and risk analysis, but also through the presence of experts from its own staff in Member States. The Agency should therefore be able to deploy liaison officers to Member States for a period of time during which the liaison officer reports to the executive director. The reports of the liaison officers should form part of the vulnerability assessment. (43) The Agency should carry out a vulnerability assessment based on objective criteria to assess the capacity and readiness of the Member States to face challenges at their external borders and to contribute to the standing corps and technical equipment pool. The vulnerability assessment should include an assessment of the equipment, infrastructure, staff, budget and financial resources of Member States as well as their contingency plans to address possible crises at the external borders. Member States should take measures to address any deficiencies identified in that assessment. The executive director should identify the measures to be taken and recommend them to the Member State concerned. The executive director should also set a time limit within which those measures should be taken and closely monitor their timely implementation. Where the necessary measures are not taken within the set time limit, the matter should be referred to the management board for a further decision. (44) If the Agency is not provided with the accurate and timely information necessary for carrying out a vulnerability assessment, it should be able to take that fact into account when performing the vulnerability assessment, unless duly justified reasons are provided for withholding the data. (45) The vulnerability assessment and the Schengen evaluation mechanism established by Council Regulation (EU) No 1053/2013 (10) are two complementary mechanisms for guaranteeing Union quality control on the proper functioning of the Schengen area and ensuring constant preparedness at both Union and national levels to respond to any challenges at the external borders. While the Schengen evaluation mechanism is the primary method for evaluating the implementation of and compliance with Union law in the Member States, the synergies between the vulnerability assessment and the Schengen evaluation mechanism should be maximised with a view to establishing an improved situational picture of the functioning of the Schengen area, avoiding, to the extent possible, duplication of efforts on the Member States' side, and ensuring the better-coordinated use of the relevant Union financial instruments supporting the management of the external borders. For that purpose, the regular exchange of information between the Agency and the Commission on the results of both mechanisms should be established. (46) Given that the Member States establish border sections, to which the Agency attributes impact levels, and that the reaction capabilities of the Member States and of the Agency should be linked to those impact levels, a fourth impact level \u2014 the critical impact level \u2014 should be established to be attributed to a border section on a temporary basis where the Schengen area is at risk and where the Agency should intervene. (47) Where a high or critical impact level is attributed to a maritime border section due to an increase of illegal immigration, the Member States concerned should take that increase into account for the planning and conducting of search and rescue operations since such a situation could generate an increase in requests for assistance for persons in distress at sea. (48) The Agency should organise appropriate technical and operational assistance to Member States in order to reinforce their capacity to implement their obligations with regard to external border control and to face challenges at the external borders resulting from an increased number of arrivals of irregular migrants or cross-border crime. Such assistance should be without prejudice to the relevant national authorities' competence to initiate criminal investigations. In that respect, the Agency should, either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State, organise and coordinate joint operations for one or more Member States, deploy border management teams, migration management support teams and return teams (collectively referred to as \u2018teams\u2019) from the standing corps and provide the necessary technical equipment. (49) Where there is a specific and disproportionate challenge at the external borders, the Agency should, either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State, organise and coordinate rapid border interventions and deploy both teams from the standing corps and technical equipment, including from the rapid reaction equipment pool. The rapid reaction equipment pool should contain a limited number of items of equipment needed for possible rapid border interventions. Rapid border interventions should provide reinforcement for a limited period of time in situations where an immediate response is required and where such an intervention would provide an effective response. To ensure that such intervention is effective, Member States should make staff that they second to the Agency, provide to the Agency for short-term deployment and deploy for the purposes of the reserve for rapid reaction available to form relevant teams and provide the necessary technical equipment. Where the crew deployed with the technical equipment of a Member State originates in that Member State, it should count as part of that Member State's contribution to the standing corps. The Agency and the Member State concerned should agree upon an operational plan. (50) Where a Member State faces specific and disproportionate migratory challenges at particular areas of its external borders characterised by large, inward, mixed migratory flows, the Member States should be able to rely on increased technical and operational reinforcements. Those reinforcements should be provided in hotspot areas by migration management support teams. Those teams should be composed of operational staff to be deployed from the standing corps and experts from the European Asylum Support Office (EASO), Europol and, where relevant, the European Union Agency for Fundamental Rights, other Union bodies, offices and agencies, and Member States. The Commission should ensure the necessary coordination of the assessment of needs submitted by Member States. The Agency should assist the Commission in the coordination among the different agencies on the ground. The Commission should, in cooperation with the host Member State and relevant Union agencies, establish the terms of cooperation at hotspot areas. The Commission should ensure the cooperation of the relevant agencies within their respective mandates and be responsible for coordinating the activities of the migration management support teams. (51) Member States should ensure that any authorities which are likely to receive applications for international protection, such as the police, border guards, immigration authorities and personnel of detention facilities, have the relevant information. They should also ensure that such authorities' personnel receive the necessary level of training which is appropriate to their tasks and responsibilities and instructions to inform applicants as to where and how applications for international protection may be lodged and instructions as to how to refer persons in a vulnerable situation to the appropriate referral mechanisms. (52) In its conclusions of 28 June 2018, the European Council reconfirmed the importance of relying on a comprehensive approach to migration and considered that migration is a challenge not only for one Member State but also for Europe as a whole. In that respect, it highlighted the importance for the Union of providing full support to ensure an orderly management of migration flows. (53) The Agency and EASO should cooperate closely in order to address effectively migratory challenges characterised by large inward mixed migratory flows, in particular at the external borders. In particular, the Agency and EASO should coordinate their activities and support Member States to facilitate procedures regarding international protection and the return procedure with regard to third-country nationals whose applications for international protection are rejected. The Agency and EASO should also cooperate in other common operational activities such as shared risk analysis, the collection of statistical data, training, and support to Member States in connection with contingency planning. (54) National authorities carrying out coast guard functions are responsible for a wide range of tasks, which may include maritime safety, security, search and rescue, border control, fisheries control, customs control, general law enforcement and environmental protection. The Agency, the European Fisheries Control Agency (EFCA) and the European Maritime Safety Agency (EMSA) should therefore strengthen their cooperation both with each other and with the national authorities carrying out coast guard functions to increase maritime situational awareness and to support coherent and cost-efficient action. Synergies between the various actors in the maritime environment should be in line with European integrated border management and maritime security strategies. (55) In hotspot areas, the Member States should cooperate with the relevant Union agencies, which should act within their respective mandates and powers, under the coordination of the Commission. The Commission, in cooperation with the relevant Union agencies, should ensure that activities in hotspot areas comply with relevant Union law and fundamental rights. (56) Where justified by the results of the vulnerability assessment or risk analysis or where a critical impact level has been temporarily attributed to one or more border sections, the executive director of the Agency should recommend to the Member State concerned to initiate and carry out joint operations or rapid border interventions. (57) Where external border control is rendered ineffective to such an extent that it risks jeopardising the functioning of the Schengen area, either because a Member State does not take the necessary measures in line with a vulnerability assessment or because a Member State facing specific and disproportionate challenges at the external borders has not requested sufficient support from the Agency or is not implementing such support, a unified, rapid and effective response should be delivered at Union level. For the purpose of mitigating these risks, and to ensure better coordination at Union level, the Commission should propose to the Council a decision that identifies the measures to be implemented by the Agency and requires the Member State concerned to cooperate with the Agency in the implementation of those measures. The implementing power to adopt such a decision should be conferred on the Council because of the potentially politically sensitive nature of the measures to be decided, which are likely to touch on national executive and enforcement powers. The Agency should then determine the actions to be taken for the practical execution of the measures indicated in the Council decision. The Agency should draw up an operational plan with the Member State concerned. The Member State concerned should facilitate the implementation of the Council decision and the operational plan by fulfilling, inter alia, its obligations as provided for in this Regulation. If a Member State does not comply with that Council decision within 30 days and does not cooperate with the Agency in the implementation of the measures contained in that decision, the Commission should be able to trigger the specific procedure provided for in Article 29 of Regulation (EU) 2016/399 to address exceptional circumstances putting the overall functioning of the area without internal border control at risk. (58) The standing corps should be composed of four categories of operational staff, namely statutory staff, staff seconded to the Agency by the Member States for a long term, staff provided by Member States for short-term deployments and staff forming part of the reserve for rapid reaction for rapid border interventions. Operational staff should consist of border guards, return escorts, return specialists, and other relevant staff. The standing corps should be deployed in the framework of teams. The actual number of operational staff deployed from the standing corps should depend on operational needs. (59) Operational staff deployed as members of the teams should have all the necessary powers to carry out border control and return tasks, including the tasks requiring executive powers, set out in relevant national law or in this Regulation. Where statutory staff exercise executive powers, the Agency should be liable for any damage caused. (60) Member States should contribute to the standing corps in accordance with Annex II for long-term secondments and Annex III for short-term deployments. The individual contributions of Member States should be established on the basis of the distribution key agreed during the negotiations in 2016 on Regulation (EU) 2016/1624 for the purposes of the rapid reaction pool and set out in Annex I to that Regulation. That distribution key should be proportionally adapted to the size of the standing corps. Those contributions should also be established in a proportionate way for the Schengen associated countries. (61) When selecting the numbers and profiles of staff to be indicated in the decision of the management board, the executive director should apply the principles of equal treatment and proportionality, in particular with regard to the national capabilities of Member States. (62) The exact timing for short-term deployments from the standing corps and for making available technical equipment co-financed under the specific actions of the Internal Security Fund or any other dedicated Union funding should be agreed between each Member State and the Agency through annual bilateral negotiations, taking into account capacity and proportionality. When requesting national contributions to the standing corps, the executive director should apply as a general rule the principles of proportionality and equal treatment of Member States with the aim of preventing situations that would substantially affect the discharge of national tasks in one Member State by requesting the deployment of the annual contributions of that Member State in one particular period of four months. Such arrangements should include the possibility for Member States to fulfil their obligations regarding deployment periods by means of non-consecutive periods. With regard to short-term deployments from the standing corps, Member States should also be able to fulfil their obligations for short-term deployment in a cumulative manner, by deploying more staff for shorter periods or by deploying the individual staff members for more than four months in accordance with the planning agreed through annual bilateral negotiations. (63) Without prejudice to the timely conclusion of the operational plan regarding sea operations, the Agency should provide participating Member States, at the earliest possible stage, with specific information on the relevant jurisdiction and applicable law, in particular on the prerogatives of the commanders of ships and aircraft, the conditions of the use of force and the imposition of restrictive or custodial measures. (64) The long-term development of human resources to secure the contributions of the Member States to the standing corps should be supported by a financial support system. For that purpose, it is appropriate to authorise the Agency to use the award of grants to the Member States without a call for proposals under financing not linked to costs subject to the fulfilment of the conditions set out in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (11). The financial support should enable Member States to hire and train additional staff to provide them with the necessary flexibility to comply with the mandatory contributions to the standing corps. The financial support system should take into account the time required for recruitment and training, and it should therefore be based on the N + 2 rule. The dedicated financing system should strike the right balance between the risks of irregularities and fraud and costs of control. This Regulation sets the essential conditions for triggering the financial support, namely the recruitment and training of the adequate number of border guards or other specialists corresponding to the number of officers seconded to the Agency for a long term or the effective deployment of officers during the Agency's operational activities for a consecutive or non-consecutive period of at least four months or on a pro-rata basis for deployments for a consecutive or a non-consecutive period of less than four months. Given the lack of relevant and comparable data on actual costs across Member States, the development of a cost-based financing scheme would be overly complex and would not address the need for a simple, fast, efficient and effective financing scheme. For the purpose of fixing the amount of such financing to different Member States, it is appropriate to use as a reference amount the annual salary of contractual agents in function group III, grade 8, step 1 of the institutions of the Union, adjusted by a corrective coefficient per Member State in line with the principle of sound financial management and in the spirit of equal treatment. When implementing such financial support, the Agency and Member States should ensure that the principles of co-financing and no double funding are complied with. (65) In order to alleviate the possible impact on the national services related to the recruitment of statutory staff for the standing corps, support should be provided to the relevant services of Member States to cover training investments for new personnel replacing such departing personnel. (66) In view of the deployment of the standing corps on the territories of third countries, the Agency should develop the capabilities for its own command and control structures as well as a procedure to ensure that the members of the teams can be held civilly and criminally liable. (67) In order to allow for effective deployments from the standing corps beginning on 1 January 2021, certain decisions and implementing measures should be taken and put in place as soon as possible. Therefore, the Agency, together with the Member States and the Commission, should engage in the preparation of such implementing measures and decisions for adoption by the management board. Such a preparatory process should encompass the relevant recruitment by the Agency and the Member States as referred to in this Regulation. (68) In order to ensure the continuity of the support for operational activities organised by the Agency, however, all deployments, including under the rapid reaction pool, to be made by 31 December 2020 should be planned and implemented in accordance with Regulation (EU) 2016/1624 and in accordance with the annual bilateral negotiations carried out in 2019. To that end, the relevant provisions of that Regulation should only be repealed with effect from 1 January 2021. (69) The Agency's workforce should consist of staff performing the tasks devoted to the Agency, either in the Agency's headquarters or as part of the standing corps. Statutory staff within the standing corps should primarily be deployed as members of the teams. It should be possible to recruit only a limited and clearly defined number of statutory staff to perform supportive functions for the establishment of the standing corps, in particular at headquarters. (70) To overcome the persistent gaps in the voluntary pooling of technical equipment from Member States, in particular as regards large-scale assets, the Agency should have its own necessary equipment to be deployed in joint operations or rapid border interventions or any other operational activities. Those assets should be authorised by the Member States as being on government service. While the Agency has been legally able to acquire or lease its own technical equipment since 2011, that possibility was significantly hindered by the lack of budgetary resources. (71) Consequently, in order to match the level of ambition underlying the establishment of the standing corps, the Commission earmarked a significant envelope under the 2021-2027 multiannual financial framework to allow the Agency to acquire, maintain and operate the necessary air, sea and land assets corresponding to its operational needs. While the acquisition of the necessary assets could be a lengthy process, especially for large assets, the Agency's own equipment should ultimately become the backbone of the operational deployments with additional contributions by Member States to be called upon in exceptional circumstances. The Agency's equipment should be largely operated by the Agency's technical crews that are part of the standing corps. In order to ensure the effective use of the proposed financial resources, the acquisition of the necessary assets should be based on a multiannual strategy decided as early as possible by the management board. It is necessary to ensure the sustainability of the Agency by means of future multiannual financial frameworks and to maintain comprehensive European integrated border management. (72) In the implementation of this Regulation, the Agency and the Member States should make the best possible use of existing capabilities in terms of human resources as well as technical equipment, both at Union and national level. (73) The long-term development of new capabilities within the European Border and Coast Guard should be coordinated between the Member States and the Agency in line with the multiannual strategic policy cycle for European integrated border management, taking into account the long duration of certain processes. That includes the recruitment and training of new border guards, which, during their career, could serve both in Member States and as part of the standing corps, the acquisition, maintenance and disposal of equipment, for which opportunities for interoperability and economies of scale should be sought, and the development of new equipment and related technologies, including through research. (74) The capability roadmap should converge the capability development plans of Member States and the multiannual planning of the Agency's resources to optimise long-term investment to best protect the external borders. (75) Taking into account the enhanced mandate of the Agency, the setting up of the standing corps and its strengthened presence on the ground at the external borders and its increased engagement in the field of return, it should be possible for the Agency to establish antenna offices situated at locations in the proximity of its significant operational activities for the duration of those activities, to act as an interface between the Agency and the host Member State, to deal with coordination and logistical and support tasks and to facilitate cooperation between the Agency and the host Member State. (76) In light of the fact that inter-agency cooperation forms part of European integrated border management, the Agency should closely cooperate with all relevant Union bodies, offices and agencies, in particular with Europol and EASO. Such cooperation should take place at the level of headquarters, in operational areas and, where relevant, at the level of antenna offices. (77) The Agency and the Member States, in particular their training academies, should cooperate closely with respect to the training of the standing corps, while ensuring that training programmes are harmonised and foster the common values enshrined in the Treaties. The Agency should be able, after obtaining the approval of the management board, to set up an Agency training centre to facilitate further the inclusion of a common European culture in the training provided. (78) The Agency should further develop common core curricula and adequate training tools for border management and return, including specific training on the protection of vulnerable persons, including children. It should also offer additional training courses and seminars related to integrated border management tasks, including for officers of the competent national bodies. The Agency should provide the members of the standing corps with specialised training relevant to their tasks and powers. That should include training on relevant Union and international law and on fundamental rights. The Agency should be authorised to organise training activities in cooperation with Member States and third countries on their territories. (79) The return of third-country nationals who do not fulfil or who no longer fulfil the conditions for entry, stay or residence in the Member States, in accordance with Directive 2008/115/EC of the European Parliament and of the Council (12), is an essential component of the comprehensive efforts to tackle illegal immigration and represents an important issue of substantial public interest. (80) The Agency should step up its assistance to Member States for returning third-country nationals, subject to Union return policy and in compliance with Directive 2008/115/EC. In particular, the Agency should coordinate and organise return operations from one or more Member States and organise and conduct return interventions to reinforce the return systems of Member States that require increased technical and operational assistance to comply with their obligation to return third-country nationals in accordance with that Directive. (81) The Agency should, in full respect for fundamental rights and without prejudice to the Member States' responsibility for issuing return decisions, provide technical and operational assistance to Member States in the return process, including in the identification of third-country nationals and in other pre-return and return-related activities of the Member States. In addition, the Agency should assist Member States in the acquisition of travel documents for return, in cooperation with the authorities of the relevant third countries. (82) The Agency should allow, subject to the agreement of the Member State concerned, the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment of the Council of Europe to conduct visits to where it carries out return operations, within the framework of the monitoring mechanism established by the members of the Council of Europe under the European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment. (83) The assistance to Member States in carrying out return procedures should include the provision of practical information on third countries of return relevant for the implementation of this Regulation, such as the provision of contact details or other logistical information necessary for the smooth and dignified conduct of return operations. The assistance should also include the operation and maintenance of a platform for the exchange of data and information necessary for the Agency to provide technical and operational assistance in accordance with this Regulation. That platform should have a communication infrastructure enabling the automated transmission of statistical data by the Member States' return management systems. (84) The possible existence of an arrangement between a Member State and a third country does not absolve the Agency or the Member States from their obligations or liability under Union or international law, in particular as regards compliance with the principle of non-refoulement and the prohibition of torture and inhuman or degrading treatment. (85) Member States should be able to cooperate at operational level with other Member States or third countries at the external borders, including as regards military operations with a law enforcement purpose, to the extent that that cooperation is compatible with the actions of the Agency. (86) The Agency should improve the exchange of information and cooperation with other Union bodies, offices and agencies, such as Europol, EASO, EMSA, the European Union Satellite Centre, EASA and the Network Manager of the EATMN in order to make the best use of information, capabilities and systems which are already available at European level, such as Copernicus, the Union Earth observation and monitoring programme. (87) Cooperation with third countries is an important element of European integrated border management. It should serve to promote European border management and return standards, to exchange information and risk analysis, and to facilitate the implementation of returns with a view to increasing their efficiency and to supporting third countries in the area of border management and migration, including through the deployment of the standing corps where such support is required to protect external borders and the effective management of the Union's migration policy. (88) Where the Commission recommends that the Council authorise it to negotiate a status agreement with a third country, the Commission should assess the fundamental rights situation relevant to the areas covered by the status agreement in that third country and inform the European Parliament thereof. (89) Cooperation with third countries should take place in the framework of the external action of the Union and in line with the principles and objectives laid down in Article 21 of the Treaty on European Union (TEU). The Commission should ensure consistency between European integrated border management and other Union policies in the field of the Union's external action and, in particular, the Common Security and Defence Policy. The Commission should be assisted by the High Representative of the Union for Foreign Affairs and Security Policy. Such cooperation should take place with regard to, in particular, the activities of the Agency taking place on the territory of third countries or involving the officials of third countries in areas such as risk analysis, planning and conduct of operations, training, information exchange and cooperation. (90) In order to ensure that the information contained in EUROSUR is as complete and up to date as possible, in particular with regard to the situation in third countries, the Agency should cooperate with the authorities of third countries either in the framework of bilateral and multilateral agreements between the Member States and third countries, including regional networks, or through working arrangements concluded between the Agency and the relevant authorities of third countries. For those purposes, the European External Action Service and Union delegations and offices should provide all information that could be relevant for EUROSUR. (91) This Regulation includes provisions on cooperation with third countries because well-structured and permanent exchange of information and cooperation with such countries, including but not limited to neighbouring third countries, are key factors for achieving the objectives of European integrated border management. It is essential that any exchange of information and any cooperation between Member States and third countries take place in full compliance with fundamental rights. (92) The assistance to third countries should complement the Agency's support for Member States in the application of Union measures relating to the implementation of European integrated border management. (93) It should be possible for the bilateral and multilateral agreements concluded by Member States with third countries in the areas covered by European integrated border management to contain security sensitive information. Where notified to the Commission, such information should be handled by the Commission in accordance with the applicable security rules. (94) To establish a comprehensive situational picture and risk analysis covering the pre-frontier area, the Agency and the national coordination centres should collect information and coordinate with immigration liaison officers deployed in third countries by Member States, the Commission, the Agency or other Union bodies, offices and agencies. (95) The False and Authentic Documents Online (\u2018FADO\u2019) system was established by Council Joint Action 98/700/JHA (13) within the General Secretariat of the Council enabling Member States' authorities to have at their disposal information on any new forgery methods that are detected and on the new genuine documents that are in circulation. (96) In its conclusions of 27 March 2017, the Council stated that the management of the FADO system is outdated and that a change of its legal basis is required in order to continue meeting the requirements of justice and home affairs policies. The Council also noted that synergies could be exploited in that regard using the Agency's expertise in the area of document fraud and the work the Agency has already been carrying out in the field. It is therefore intended that the Agency take over the administration and the operational and technical management of the FADO system from the General Secretariat of the Council as soon as the European Parliament and the Council have adopted the relevant legal act on the FADO system replacing Joint Action 98/700/JHA. (97) Prior to the adoption of the relevant legal act on the FADO system, it is desirable to ensure that the FADO system is fully operational until the transfer is effectively carried out and the existing data are transferred to the new system. The ownership of the existing data would then be transferred to the Agency. (98) Any processing of personal data by the Agency within the framework of this Regulation should be conducted in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (14). (99) Any processing of personal data by Member States within the framework of this Regulation should be conducted in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (15) or Directive (EU) 2016/680 of the European Parliament and of the Council (16), as applicable. (100) In the context of return, third-country nationals frequently do not hold any identification documents and do not cooperate as regards the establishment of their identity by withholding information or providing incorrect personal data. Given the particular policy need for expedient return procedures, it is necessary for the Agency to be able to restrict certain rights of data subjects so as to prevent the abuse of such rights from impeding the proper implementation of return procedures and the successful enforcement of return decisions by the Member States or from preventing the Agency from performing its tasks efficiently. In particular, the exercise of the right to the restriction of processing could significantly delay and obstruct the carrying out of the return operations. Furthermore, in some cases, the right of access by the third-country national could jeopardise a return operation by increasing the risk of absconding should the third-country national learn that the Agency is processing his or her data in the context of a planned return operation. The right to rectification could increase the risk that the third-country national in question will mislead the authorities by providing incorrect data. In order to enable the Agency to restrict certain rights of data subjects, it should be able to adopt internal rules on such restrictions. (101) In order to properly implement its tasks in the area of return, including by assisting Member States in the proper implementation of return procedures and the successful enforcement of return decisions, as well as to facilitate return operations, the Agency might need to transfer the personal data of returnees to third countries. The third countries of return are not often subject to adequacy decisions adopted by the Commission under Article 45 of Regulation (EU) 2016/679 or under Article 36 of Directive (EU) 2016/680, and have often not concluded or do not intend to conclude a readmission agreement with the Union or otherwise provide for appropriate safeguards within the meaning of Article 48 of Regulation (EU) 2018/1725 or within the meaning of the national provisions transposing Article 37 of Directive (EU) 2016/680. However, despite the extensive efforts of the Union in cooperating with the main countries of origin of illegally staying third-country nationals subject to an obligation to return, it is not always possible to ensure that such third countries systematically comply with the obligation established by international law to readmit their own nationals. Readmission agreements concluded or being negotiated by the Union or the Member States which provide for appropriate safeguards for personal data cover a limited number of such third countries. Where such agreements do not yet exist, personal data should be transferred by the Agency for the purposes of facilitating the return operations of the Union, provided that the conditions laid down in point (d) of Article 50(1) of Regulation (EU) 2018/1725 are met. (102) Any transfer of personal data by Member States to third countries should be carried out in accordance with Regulation (EU) 2016/679 and Directive (EU) 2016/680, as applicable. In the absence of readmission agreements, and as an exception to the requirement that adequacy decisions have been adopted or appropriate safeguards have been provided for, it should be possible for Member States to transfer personal data to the authorities of third countries for the purposes of implementing Union return policy. It should be possible to use the derogation for specific situations provided for in Article 49 of Regulation (EU) 2016/679 and Article 38 of Directive (EU) 2016/680, as applicable, subject to the conditions set out in those articles. (103) This Regulation respects the fundamental rights and observes the principles recognised by Articles 2 and 6 TEU and by the Charter of Fundamental Rights of the European Union (\u2018the Charter\u2019), in particular respect for human dignity, the right to life, the prohibition of torture and inhuman or degrading treatment or punishment, the prohibition of trafficking in human beings, the right to liberty and security, the right to the protection of personal data, the right of access to documents, the right to asylum and to protection against removal and expulsion, non-refoulement, non-discrimination and the rights of the child. (104) This Regulation should establish a complaints mechanism for the Agency in cooperation with the fundamental rights officer, to safeguard the respect for fundamental rights in all the activities of the Agency. This should be an administrative mechanism whereby the fundamental rights officer should be responsible for handling complaints received by the Agency in accordance with the right to good administration. The fundamental rights officer should review the admissibility of a complaint, register admissible complaints, forward all registered complaints to the executive director, forward complaints concerning members of the teams to the home Member State, and register the follow-up by the Agency or that Member State. The mechanism should be effective, ensuring that complaints are properly followed up. The complaints mechanism should be without prejudice to access to administrative and judicial remedies and not constitute a requirement for seeking such remedies. Criminal investigations should be conducted by the Member States. In order to increase transparency and accountability, the Agency should report on the complaints mechanism in its annual report. The report should cover in particular the number of complaints it has received, the types of fundamental rights violations involved, the operations concerned and, where possible, the follow-up measures taken by the Agency and Member States. The fundamental rights officer should have access to all information concerning respect for fundamental rights in relation to all the activities of the Agency. The fundamental rights officer should be provided with the resources and staff necessary to enable him or her to effectively perform all his or her tasks in accordance with this Regulation. The staff provided to the fundamental rights officer should have the skills and seniority that correspond to the expansion of activities and powers of the Agency. (105) The Agency should be independent as regards technical and operational matters and have legal, administrative and financial autonomy. To that end, it is necessary and appropriate that it should be a Union body having legal personality and exercising the implementing powers that are conferred upon it by this Regulation. (106) The Commission and the Member States should be represented within a management board to exercise oversight over the Agency. The management board should, where possible, consist of the operational heads of the national services responsible for border management or their representatives. The parties represented in the management board should make efforts to limit turnover of their representatives in order to ensure continuity of the management board's work. The management board should be entrusted with the necessary powers to establish the Agency's budget, verify its execution, adopt appropriate financial rules, establish transparent working procedures for decision-making by the Agency and appoint the executive director and three deputy executive directors, each of whom should be assigned responsibilities in a certain field of competence of the Agency, such as managing the standing corps, overseeing the Agency's tasks regarding returns or managing the Agency's involvement in large-scale IT systems. The Agency should be governed and operated taking into account the principles of the common approach on Union decentralised agencies adopted on 19 July 2012 by the European Parliament, the Council and the Commission. (107) Given the involvement of the European Parliament in the matters governed by this Regulation, the chairperson of the management board should be able to invite an expert of the European Parliament to attend the meetings of the management board. (108) Each year, the management board should prepare a single programming document. When preparing that document, the management board should take into account the recommendations of the Interinstitutional Working Group on decentralised agencies' resources. (109) In order to guarantee the autonomy of the Agency, it should be granted a stand-alone budget with a revenue which comes mostly from a contribution from the Union. The Agency's budget should be prepared in accordance with the principle of performance-based budgeting, taking into account the Agency's objectives and the expected results of its tasks. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors. In exceptional situations where the available budget is deemed insufficient and the budgetary procedure does not allow an adequate response to fast-developing situations, the Agency should have the possibility of receiving grants from Union funds to fulfil its tasks. (110) The executive director, in his or her capacity as an authorising officer, should assess the financial risks related to the Agency's activities on a regular basis and take the necessary mitigating measures in accordance with the financial framework applicable to the Agency and inform the management board accordingly. (111) The Agency is expected to face challenging circumstances in the coming years as regards fulfilling exceptional needs for recruiting and retaining qualified staff from the broadest possible geographical basis. (112) In the spirit of shared responsibility, the Agency should require the staff it employs, in particular the statutory staff of the standing corps, including statutory staff deployed in operational activities, to possess the same level of training, special expertise and professionalism as staff seconded or employed by the Member States. Therefore, the Agency should review and evaluate whether its statutory staff conduct themselves properly in operational activities in the field of border control and return. (113) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (17) should apply without restriction to the Agency, which should accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (18). (114) In accordance with Council Regulation (EU) 2017/1939 (19), the European Public Prosecutor's Office should be able to investigate and prosecute fraud and other criminal offences affecting the Union's financial interests as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (20). (115) Regulation (EC) No 1049/2001 of the European Parliament and of the Council (21) should apply to the Agency. The Agency should be as transparent as possible about its activities, without jeopardising the attainment of the objective of its operations. It should make public the information about all of its activities. It should likewise ensure that the public and any interested party are rapidly given information with regard to its work. (116) The Agency should also report on its activities to the European Parliament, to the Council and to the Commission to the fullest extent. (117) The Commission should carry out an evaluation of this Regulation. That evaluation should assess, inter alia, the attractiveness of the Agency as an employer for the recruitment of statutory staff with a view to ensuring the quality of the candidates and geographical balance. (118) The external borders referred to in this Regulation are those to which the provisions of Title II of Regulation (EU) 2016/399 apply, which includes the external borders of Schengen Member States in accordance with Protocol No 19 on the Schengen acquis integrated into the framework of the European Union, annexed to the TEU and to the Treaty on the Functioning of the European Union (TFEU). (119) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (22). (120) Since the objectives of this Regulation, namely the development and implementation of a system of integrated management of the external borders to ensure the proper functioning of the Schengen area, cannot be sufficiently achieved by the Member States acting in an uncoordinated manner but can rather, by reason of the absence of controls at internal borders, the significant migratory challenges at the external borders, the need to monitor efficiently the crossing of those borders, and the need to contribute to a high level of internal security within the Union, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (121) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters' association with the implementation, application and development of the Schengen acquis (23), which fall within the area referred to in Article 1, point A of Council Decision 1999/437/EC (24). The Arrangement between the European Community and the Republic of Iceland and the Kingdom of Norway on the modalities of the participation by those States in the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (25) provides for rules on the participation by those countries in the work of the Agency, including provisions on financial contributions and staff. (122) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (26) which fall within the area referred to in Article 1, point A of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (27). (123) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (28) which fall within the area referred to in Article 1, point A of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (29). (124) The Arrangement between the European Community, of the one part, and the Swiss Confederation and the Principality of Liechtenstein, of the other part, on the modalities of the participation by those States in the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (30) provides for rules on the participation by those countries in the work of the Agency, including provisions on financial contributions and staff. (125) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it, or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (126) This Regulation constitutes a development of provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (31); the United Kingdom is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (127) This Regulation constitutes a development of provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (32); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (128) The Agency should facilitate the organisation of specific activities in which the Member States may avail themselves of the expertise and facilities which Ireland and the United Kingdom may be willing to offer, on terms to be decided on a case-by-case basis by the management board. To that end, representatives of Ireland may be invited to attend meetings of the management board which allow them to participate fully in the preparation of such specific activities. Representatives of the United Kingdom may be invited to attend the meetings of the management board until the day on which the Treaties cease to apply to the United Kingdom pursuant to Article 50(3) TEU. (129) Although the United Kingdom does not participate in this Regulation, it has been granted the possibility to cooperate with the European Border and Coast Guard in view of its position as a Member State. In view of the submission by the United Kingdom of the notification of its intention to withdraw from the Union pursuant to Article 50 TEU, special arrangements applicable to the operational cooperation with the United Kingdom on the basis of this Regulation should be applicable until the day on which the Treaties cease to apply to the United Kingdom pursuant to Article 50(3) TEU or provided that a withdrawal agreement concluded with the United Kingdom in accordance with Article 50 TEU that regulates such special arrangements has entered into force. (130) A controversy exists between the Kingdom of Spain and the United Kingdom on the demarcation of the borders of Gibraltar. (131) The suspension of the applicability of this Regulation to the borders of Gibraltar does not imply any change in the respective positions of the States concerned. (132) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (33) on 7 November 2018 and delivered an opinion on 30 November 2018. (133) This Regulation aims to amend and expand the provisions of Regulations (EU) 2016/1624 and (EU) No 1052/2013. Since the amendments to be made are substantial in number and nature, those legal acts should, for the sake of clarity, be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I EUROPEAN BORDER AND COAST GUARD Article 1 Subject matter This Regulation establishes a European Border and Coast Guard to ensure European integrated border management at the external borders with a view to managing those borders efficiently in full compliance with fundamental rights and to increasing the efficiency of the Union return policy. This Regulation addresses migratory challenges and potential future challenges and threats at the external borders. It ensures a high level of internal security within the Union in full respect of fundamental rights, while safeguarding the free movement of persons within the Union. It contributes to the detection, prevention and combating of cross-border crime at the external borders. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018external borders\u2019 means external borders as defined in point 2 of Article 2 of Regulation (EU) 2016/399; (2) \u2018border crossing point\u2019 means border crossing point as defined in point 8 of Article 2 of Regulation (EU) 2016/399; (3) \u2018border control\u2019 means border control as defined in point 10 of Article 2 of Regulation (EU) 2016/399; (4) \u2018border checks\u2019 means border checks as defined in point 11 of Article 2 of Regulation (EU) 2016/399; (5) \u2018border surveillance\u2019 means border surveillance as defined in point 12 of Article 2 of Regulation (EU) 2016/399; (6) \u2018air border surveillance\u2019 means the surveillance of any flight of a manned or unmanned aircraft and its passengers or cargo to or from the territory of the Member States which is not an internal flight as defined in point 3 of Article 2 of Regulation (EU) 2016/399; (7) \u2018situational awareness\u2019 means the ability to monitor, detect, identify, track and understand illegal cross-border activities in order to find reasoned grounds for reaction measures on the basis of combining new information with existing knowledge, and to be better able to reduce the loss of lives of migrants at, along or in the proximity of the external borders; (8) \u2018reaction capability\u2019 means the ability to perform actions aimed at countering illegal cross-border activities at, along or in the proximity of the external borders, including the means and timelines to react adequately; (9) \u2018EUROSUR\u2019 means the framework for information exchange and cooperation between the Member States and the European Border and Coast Guard Agency; (10) \u2018situational picture\u2019 means an aggregation of geo-referenced near-real-time data and information received from different authorities, sensors, platforms and other sources which is transmitted across secured communication and information channels and can be processed and selectively displayed and shared with other relevant authorities in order to achieve situational awareness and support the reaction capability at, along or in the proximity of the external borders and the pre-frontier area; (11) \u2018external border section\u2019 means the whole or a part of the external border of a Member State, as defined by national law or as determined by the national coordination centre or any other responsible national authority; (12) \u2018cross-border crime\u2019 means any serious crime with a cross-border dimension that is committed or attempted at, along or in the proximity of the external borders; (13) \u2018pre-frontier area\u2019 means the geographical area beyond the external borders which is relevant for managing the external borders through risk analysis and situational awareness; (14) \u2018incident\u2019 means a situation relating to illegal immigration, cross-border crime, or a risk to the lives of migrants at, along or in the proximity of, the external borders; (15) \u2018statutory staff\u2019 means staff employed by the European Border and Coast Guard Agency in accordance with the Staff Regulations of Officials of the European Union (the \u2018Staff Regulations\u2019) and the Conditions of Employment of Other Servants of the Union (the \u2018Conditions of Employment\u2019) laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (34); (16) \u2018operational staff\u2019 means border guards, return escorts, return specialists and other relevant staff constituting the European Border and Coast Guard standing corps in accordance with the four categories set out in Article 54(1), acting as members of the teams having executive powers, where applicable, and the statutory staff responsible for the functioning of the European Travel Information and Authorisation System (ETIAS) Central Unit that are not deployable as members of the teams; (17) \u2018member of the teams\u2019 means a member of the European Border and Coast Guard standing corps deployed through border management teams, migration management support teams and return teams; (18) \u2018border management teams\u2019 means teams formed from the European Border and Coast Guard standing corps to be deployed during joint operations at the external borders and rapid border interventions in Member States and third countries; (19) \u2018migration management support teams\u2019 means teams of experts which provide technical and operational reinforcement to Member States, including at hotspot areas, composed of operational staff, experts from the European Asylum Support Office (EASO) and Europol and, where relevant, experts from the European Union Agency for Fundamental Rights (FRA), other Union bodies, offices and agencies and Member States; (20) \u2018host Member State\u2019 means a Member State in which a joint operation or a rapid border intervention, a return operation or a return intervention takes place, or from which it is launched, or in which a migration management support team is deployed; (21) \u2018home Member State\u2019 means the Member State from which a staff member is deployed or seconded to the European Border and Coast Guard standing corps; (22) \u2018participating Member State\u2019 means a Member State which participates in a joint operation, rapid border intervention, return operation, return intervention or in a deployment of a migration management support team, by providing technical equipment or staff of the European Border and Coast Guard standing corps, as well as a Member State which participates in return operations or return interventions by providing technical equipment or staff, but which is not a host Member State; (23) \u2018hotspot area\u2019 means an area created at the request of the host Member State in which the host Member State, the Commission, relevant Union agencies and participating Member States cooperate, with the aim of managing an existing or potential disproportionate migratory challenge characterised by a significant increase in the number of migrants arriving at the external borders; (24) \u2018return\u2019 means return as defined in point 3 of Article 3 of Directive 2008/115/EC; (25) \u2018return decision\u2019 means an administrative or judicial decision or act stating or declaring the stay of a third-country national to be illegal and imposing or stating an obligation to return that respects Directive 2008/115/EC; (26) \u2018returnee\u2019 means an illegally staying third-country national who is the subject of an enforceable return decision; (27) \u2018return operation\u2019 means an operation that is organised or coordinated by the European Border and Coast Guard Agency and involves technical and operational reinforcement provided to one or more Member States under which returnees from one or more Member States are returned, either on a forced or voluntary basis, irrespective of the means of transport; (28) \u2018return intervention\u2019 means an activity of the European Border and Coast Guard Agency providing Member States with enhanced technical and operational assistance consisting of the deployment of return teams and the organisation of return operations; (29) \u2018return teams\u2019 means teams formed from the European Border and Coast Guard standing corps to be deployed during return operations, return interventions in Member States or other operational activities linked to the implementation of return-related tasks; (30) \u2018immigration liaison officer\u2019 means immigration liaison officer as defined in point 1 of Article 2 of Regulation (EU) 2019/1240 of the European Parliament and of the Council (35). Article 3 European integrated border management 1. European integrated border management shall consist of the following components: (a) border control, including measures to facilitate legitimate border crossings and, where appropriate: measures related to the prevention and detection of cross-border crime at the external borders, in particular migrant smuggling, trafficking in human beings, and terrorism; and mechanisms and procedures for the identification of vulnerable persons and unaccompanied minors, and for the identification of persons who are in need of international protection or wish to apply for such protection, the provision of information to such persons, and the referral of such persons; (b) search and rescue operations for persons in distress at sea launched and carried out in accordance with Regulation (EU) No 656/2014 and with international law, taking place in situations which may arise during border surveillance operations at sea; (c) analysis of the risks for internal security and analysis of the threats that may affect the functioning or security of the external borders; (d) information exchange and cooperation between Member States in the areas covered by this Regulation, as well as information exchange and cooperation between Member States and the European Border and Coast Guard Agency, including the support coordinated by the European Border and Coast Guard Agency; (e) inter-agency cooperation among the national authorities in each Member State which are responsible for border control or for other tasks carried out at the border, as well as between authorities responsible for return in each Member State, including the regular exchange of information through existing information exchange tools, including, where appropriate, cooperation with national bodies in charge of protecting fundamental rights; (f) cooperation among the relevant Union institutions, bodies, offices and agencies in the areas covered by this Regulation, including through regular exchange of information; (g) cooperation with third countries in the areas covered by this Regulation, focusing in particular on neighbouring third countries and on those third countries which have been identified through risk analysis as being countries of origin or transit for illegal immigration; (h) technical and operational measures within the Schengen area which are related to border control and designed to address illegal immigration and to counter cross-border crime better; (i) the return of third-country nationals who are the subject of return decisions issued by a Member State; (j) the use of state-of-the-art technology including large-scale information systems; (k) a quality control mechanism, in particular the Schengen evaluation mechanism, the vulnerability assessment and possible national mechanisms, to ensure the implementation of Union law in the area of border management; (l) solidarity mechanisms, in particular Union funding instruments. 2. Fundamental rights, education and training, as well as research and innovation shall be overarching components in the implementation of European integrated border management. Article 4 European Border and Coast Guard The national authorities of Member States responsible for border management, including coast guards to the extent that they carry out border control tasks, the national authorities responsible for return and the European Border and Coast Guard Agency (\u2018the Agency\u2019) shall constitute the European Border and Coast Guard. Article 5 European Border and Coast Guard Agency 1. The Agency shall be governed by this Regulation. 2. The Agency shall include the European Border and Coast Guard standing corps (\u2018the standing corps\u2019) referred to in Article 54 with a capacity of up to 10 000 operational staff in accordance with Annex I. 3. To ensure coherent European integrated border management, the Agency shall facilitate and render more effective the application of Union measures relating to the management of the external borders, in particular Regulation (EU) 2016/399, and of Union measures relating to return. 4. The Agency shall contribute to the continuous and uniform application of Union law, including the Union acquis on fundamental rights, in particular the Charter of Fundamental Rights of the European Union (\u2018the Charter\u2019), at external borders. Its contribution shall include the exchange of good practices. Article 6 Accountability The Agency shall be accountable to the European Parliament and to the Council in accordance with this Regulation. Article 7 Shared responsibility 1. The European Border and Coast Guard shall implement European integrated border management as a shared responsibility of the Agency and of the national authorities responsible for border management, including coast guards to the extent that they carry out maritime border surveillance operations and any other border control tasks. Member States shall retain primary responsibility for the management of their sections of the external borders. 2. The Agency shall provide technical and operational assistance in the implementation of measures relating to return as referred to in Article 48 of this Regulation, upon request of the Member State concerned or on its own initiative and with the agreement of the Member State concerned. Member States shall retain sole responsibility for issuing return decisions and for adopting the measures pertaining to the detention of returnees in accordance with Directive 2008/115/EC. 3. Member States shall ensure the management of their external borders and the enforcement of return decisions, in close cooperation with the Agency, in their own interests and in the common interest of all Member States in full compliance with Union law, including respect for fundamental rights, and in accordance with the multiannual strategic policy cycle for European integrated border management referred to in Article 8. 4. The Agency shall support the application of Union measures relating to the management of the external borders and the enforcement of return decisions by reinforcing, assessing and coordinating the actions of Member States and by providing technical and operational assistance in the implementation of those measures and in return matters. The Agency shall not support any measures or be involved in any activities related to controls at internal borders. The Agency shall be fully responsible and accountable for any decision it takes and for any activity for which it is solely responsible under this Regulation. 5. Member States may cooperate at an operational level with other Member States or third countries, where such cooperation is compatible with the tasks of the Agency. Member States shall refrain from any activity which could jeopardise the functioning of the Agency or the attainment of its objectives. Member States shall report to the Agency on that operational cooperation with other Member States or third countries at the external borders and in the field of return. The executive director shall inform the management board of such matters on a regular basis and at least once a year. Article 8 Multiannual strategic policy cycle for European integrated border management 1. The Commission and the European Border and Coast Guard shall ensure the effectiveness of European integrated border management by means of a multiannual strategic policy cycle that is adopted in accordance with the procedure laid down in paragraph 4. 2. The multiannual strategic policy for the European integrated border management shall set out how the challenges in the area of border management and return are to be addressed in a coherent, integrated and systematic manner. It shall set out the policy priorities and provide strategic guidelines for a period of five years in relation to the components set out in Article 3. 3. The multiannual strategic policy cycle for European integrated border management shall consist of four stages as set out in paragraphs 4 to 7. 4. On the basis of the strategic risk analysis for European integrated border management referred to in Article 29(2), the Commission shall prepare a policy document developing a multiannual strategic policy for European integrated border management. The Commission shall submit that policy document to the European Parliament and to the Council for discussion. Following that discussion, the Commission shall adopt a communication establishing the multiannual strategic policy for European integrated border management. 5. In order to implement the multiannual strategic policy for European integrated border management, the Agency shall, by a decision of the management board, on the basis of a proposal from the executive director that is prepared in close cooperation with the Member States and the Commission, establish a technical and operational strategy for European integrated border management. Where justified, the Agency shall take into account the specific situations of the Member States, in particular their geographical locations. The technical and operational strategy shall be in line with Article 3 and the multiannual strategic policy for European integrated border management. It shall promote and support the implementation of European integrated border management in all Member States. 6. In order to implement the multiannual strategic policy for European integrated border management, the Member States shall establish national strategies for European integrated border management through close cooperation between all national authorities responsible for the management of external borders and return. Those national strategies shall be in line with Article 3, the multiannual strategic policy for European integrated border management and the technical and operational strategy. 7. Four years after the adoption of the multiannual strategic policy for European integrated border management, the Commission shall carry out a thorough evaluation of its implementation. The results of that evaluation shall be taken into account in the preparation of the following multiannual strategic policy cycle. Member States and the Agency shall provide the Commission with the necessary information in a timely manner for the carrying out of that evaluation. The Commission shall communicate the results of that evaluation to the European Parliament and to the Council. 8. Where the situation at the external borders or in the area of return requires a change of the policy priorities, the Commission shall amend the multiannual strategic policy for European integrated border management or relevant parts thereof in accordance with the procedure set out in paragraph 4. Where the Commission amends the multiannual strategic policy as provided for in the first subparagraph, the technical and operational strategy and the national strategies shall, where necessary, be adapted. Article 9 Integrated planning 1. On the basis of the multiannual strategic policy cycle for European integrated border management, the European Border and Coast Guard shall establish an integrated planning process for border management and return, including operational planning, contingency planning and capability development planning processes. That integrated planning process shall be established in accordance with paragraphs 2, 3 and 4 of this Article. 2. Member States and the Agency shall adopt operational plans for border management and return. The operational plans of Member States related to border sections with high and critical impact levels shall be coordinated with neighbouring Member States and with the Agency with a view to implementing the necessary cross-border measures and providing for support by the Agency. For the activities of the Agency, operational planning processes for the following year shall be set out in an annex to the single programming document referred to in Article 102. For each specific operational activity, operational planning processes shall result in the operational plans referred to in Article 38 and Article 74(3). The operational plans or parts thereof may be classified where appropriate, in accordance with Article 92. 3. Member States shall each adopt a contingency plan for the management of their borders and return. In line with national integrated border management strategies, the contingency plans shall describe all the necessary measures and resources for the possible reinforcement of capabilities, including logistics and support both at national level and from the Agency. The part of the contingency plans that requires additional support from the European Border and Coast Guard shall be jointly prepared by the Member State concerned and the Agency, in close coordination with neighbouring Member States. 4. Member States shall adopt national capability development plans for border management and return in line with their national integrated border management strategies. Those national capability development plans shall describe the medium- to long-term evolution of the national capabilities for border management and return. The national capability development plans shall address the development of each component of European integrated border management, in particular the recruitment and training policy of border guards and return specialists, the acquisition and maintenance of equipment, necessary research and development activities, and the corresponding funding requirements and sources. 5. The contingency plans and national capability development plans referred to in paragraphs 3 and 4 shall be based on scenarios that are derived from risk analysis. Those scenarios shall reflect the possible evolution of the situation at the external borders and in the area of illegal immigration and the challenges identified in the multiannual strategic policy cycle for European integrated border management. Those scenarios shall be set out in the contingency plans and national capability development plans to which they relate. 6. The methodology and the procedure for establishing the plans referred to in paragraphs 3 and 4 shall be adopted by the management board, after consultation with the Member States, on the basis of a proposal of the executive director. 7. The Agency shall prepare an overview of the national capability development plans and a multiannual strategy for the acquisition of the Agency's equipment referred to in Article 63 and the multiannual planning for profiles of staff for the standing corps. The Agency shall share that overview with the Member States and with the Commission with a view to identifying possible synergies and opportunities for cooperation in the various areas covered by the national capability development plans, including joint procurement. On the basis of the identified synergies, the Agency may invite the Member States to participate in follow-up actions for cooperation. 8. The management board shall meet at least once a year to discuss and approve the capability roadmap of the European Border and Coast Guard. The capability roadmap shall be proposed by the executive director on the basis of the overview of the national capability development plans, taking into account, inter alia, the results of the risk analysis and vulnerability assessments carried out in accordance with Articles 29 and 32 and the Agency's own multiannual plans. Once the capability roadmap is approved by the management board, it shall be annexed to the technical and operational strategy referred to in Article 8(5). CHAPTER II FUNCTIONING OF THE EUROPEAN BORDER AND COAST GUARD SECTION 1 Tasks of the European Border and Coast Guard Agency Article 10 Tasks of the European Border and Coast Guard Agency 1. The Agency shall perform the following tasks: (a) monitor migratory flows and carry out risk analysis as regards all aspects of integrated border management; (b) monitor the operational needs of Member States related to the implementation of returns, including by collecting operational data; (c) carry out vulnerability assessments, including assessments of the capacity and readiness of Member States to face threats and challenges at the external borders; (d) monitor the management of the external borders through liaison officers of the Agency in Member States; (e) monitor compliance with fundamental rights in all of its activities at the external borders and in return operations; (f) support the development and operation of EUROSUR; (g) assist Member States in circumstances requiring increased technical and operational assistance at the external borders by coordinating and organising joint operations, taking into account that some situations may involve humanitarian emergencies and rescue at sea in accordance with Union and international law; (h) assist Member States in circumstances requiring increased technical and operational assistance at the external borders by launching rapid border interventions at the external borders of those Member States facing specific and disproportionate challenges, taking into account that some situations may involve humanitarian emergencies and rescue at sea in accordance with Union and international law; (i) provide technical and operational assistance to Member States and third countries in accordance with Regulation (EU) No 656/2014 and international law, in support of search and rescue operations for persons in distress at sea which may arise during border surveillance operations at sea; (j) deploy the standing corps in the framework of border management teams, migration management support teams and return teams (collectively referred to as \u2018teams\u2019) during joint operations, as well as in rapid border interventions, return operations and return interventions; (k) set up a technical equipment pool, including a rapid reaction equipment pool, to be deployed in joint operations, in rapid border interventions and in the framework of migration management support teams, as well as in return operations and return interventions; (l) develop and manage, with the support of an internal quality control mechanism, its own human and technical capabilities to contribute to the standing corps, including to the recruitment and training of the members of its staff acting as members of the teams, and the technical equipment pool; (m) within the framework of the migration management support teams at hotspot areas: (i) deploy operational staff and technical equipment to provide assistance in screening, debriefing, identification and fingerprinting; (ii) establish a procedure for referring and providing initial information to persons who are in need of international protection or wish to apply for such protection, including a procedure for the identification of vulnerable groups, in cooperation with EASO and competent national authorities; (n) provide assistance at all stages of the return process without entering into the merits of return decisions, which remain the sole responsibility of the Member States, assist with the coordination and organisation of return operations and provide technical and operational support to implement the obligation to return returnees and technical and operational support to return operations and interventions, including in circumstances requiring increased assistance; (o) set up a pool of forced-return monitors; (p) deploy return teams during return interventions; (q) within the respective mandates of the agencies concerned, cooperate with Europol and Eurojust and provide support to Member States in circumstances requiring increased technical and operational assistance at the external borders in the fight against cross-border crime and terrorism; (r) cooperate with EASO within their respective mandates, in particular to facilitate measures in cases where third-country nationals whose applications for international protection have been rejected by means of a final decision are subject to return; (s) cooperate with the FRA, within their respective mandates, in order to ensure the continuous and uniform application of the Union acquis on fundamental rights; (t) cooperate with the European Fisheries Control Agency (EFCA) and the European Maritime Safety Agency (EMSA), within their respective mandates, in order to support national authorities carrying out coast guard functions, as set out in Article 69, including the saving of lives at sea, by providing services, information, equipment and training, as well as by coordinating multipurpose operations; (u) cooperate with third countries in relation to the areas covered by this Regulation, including through the possible operational deployment of border management teams in third countries; (v) assist Member States and third countries in the context of technical and operational cooperation between them in the matters covered by this Regulation; (w) assist Member States and third countries in the training of national border guards, other relevant staff and experts on return, including through the establishment of common training standards and programmes, including on fundamental rights; (x) participate in the development and management of research and innovation activities relevant for the control of the external borders, including the use of advanced surveillance technology, and develop its own pilot projects, where necessary, for the carrying out of activities as provided for in this Regulation; (y) develop technical standards for information exchange; (z) support the development of technical standards for equipment in the area of border control and return, including for the interconnection of systems and networks, and support, as appropriate, the development of common minimum standards for external border surveillance, in line with the respective competences of the Member States and of the Commission; (aa) establish and maintain the communication network referred to in Article 14; (ab) develop and operate, in accordance with Regulation (EU) 2018/1725, information systems that enable swift and reliable exchanges of information regarding emerging risks in the management of the external borders, illegal immigration and return, in close cooperation with the Commission, Union bodies, offices and agencies as well as the European Migration Network established by Council Decision 2008/381/EC (36); (ac) provide the necessary assistance for the development of a common information-sharing environment, including interoperability of systems, as appropriate; (ad) follow high standards for border management allowing for transparency and public scrutiny in full respect of the applicable law and ensuring respect for, and protection and promotion of, fundamental rights; (ae) manage and operate the False and Authentic Documents Online system referred to in Article 79 and support the Member States by facilitating the detection of document fraud; (af) fulfil the tasks and obligations entrusted to the Agency under Regulation (EU) 2018/1240 of the European Parliament and of the Council (37) and ensure the setting up and operation of the ETIAS Central Unit in accordance with Article 7 of that Regulation; (ag) assist Member States in facilitating persons to cross the external borders. 2. The Agency shall communicate on matters falling within its mandate. It shall provide the public with accurate, detailed, timely and comprehensive information about its activities. Such communication shall not be detrimental to the tasks referred to in paragraph 1 of this Article, and in particular shall not reveal operational information which, if made public, would jeopardise attainment of the objective of operations. The Agency shall communicate without prejudice to Article 92 and in accordance with relevant communication and dissemination plans adopted by the management board and in close cooperation, where appropriate, with other bodies, offices and agencies. SECTION 2 Information exchange and cooperation Article 11 Duty to cooperate in good faith The Agency, the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, and the national authorities responsible for return shall be subject to a duty to cooperate in good faith and an obligation to exchange information. Article 12 Obligation to exchange information 1. In order to perform the tasks conferred on them by this Regulation, the Agency, the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, and the national authorities responsible for return shall, in accordance with this Regulation and other relevant Union and national law regarding the exchange of information, share in a timely and accurate manner all necessary information. 2. The Agency shall take appropriate measures to facilitate the exchange of information relevant to its tasks with the Commission and the Member States. Where information is relevant to the performance of its tasks, the Agency shall exchange that information with other relevant Union bodies, offices and agencies for the purpose of risk analysis, collecting statistical data, assessing the situation in third countries, training and the support to Member States in connection with contingency planning. For that purpose, the necessary tools and structures shall be developed between the Union bodies, offices and agencies. 3. The Agency shall take all necessary measures to facilitate the exchange of information relevant for its tasks with Ireland and the United Kingdom where that information relates to the activities in which they participate in accordance with Article 70 and Article 100(5). Article 13 National contact points 1. Each Member State shall appoint a national contact point for communication with the Agency on all matters pertaining to the activities of the Agency, without prejudice to the role of the national coordination centres. The national contact points shall be reachable at all times and shall ensure the timely dissemination of all information from the Agency to all the relevant authorities within the Member State concerned, in particular the members of the management board and the national coordination centre. 2. Member States may designate up to two staff members representing their national contact point to be assigned to the Agency as liaison officers. The liaison officers shall facilitate communication between the national contact point and the Agency and may, where necessary, attend relevant meetings. 3. The Agency shall provide liaison officers with the necessary premises within its headquarters and with adequate support for the performance of their duties. All other costs that arise in connection with the deployment of liaison officers shall be covered by the Member State. The management board shall specify the rules and conditions of the deployment, as well as the rules concerning adequate support to be provided. Article 14 Communication network 1. The Agency shall establish and maintain a communication network in order to provide communication and analytical tools and allow for the exchange of sensitive non-classified and classified information in a secure manner and in near real time with, and among, the national coordination centres. Any system or application using the communication network shall comply with Union law on data protection throughout its life cycle. The communication network shall be operational twenty-four hours a day and seven days a week and shall allow for: (a) bilateral and multilateral information exchange in near real time; (b) audio and video conferencing; (c) secure handling, storing, transmission and processing of sensitive non-classified information; (d) secure handling, storing, transmission and processing of EU classified information up to the level of CONFIDENTIEL UE/EU CONFIDENTIAL or equivalent national classification levels, ensuring that classified information is handled, stored, transmitted and processed in a separate and duly accredited part of the communication network. 2. The Agency shall provide technical support and ensure that the communication network is permanently available and can support the communication and information system managed by the Agency. Article 15 Information exchange systems and applications managed by the Agency 1. The Agency may take all necessary measures to facilitate the exchange of information relevant to its tasks with the European Parliament, the Council, the Commission, the Member States and, where appropriate, other Union institutions, and the Union bodies, offices and agencies and international organisations listed in Article 68(1) and third countries as referred to in Article 71. 2. The Agency shall develop, deploy and operate an information system capable of exchanging classified and sensitive non-classified information with the actors referred to in paragraph 1 of this Article, and of exchanging personal data referred to in Articles 86 to 91 in accordance with Article 92. 3. The Agency shall deploy the information systems referred to in paragraph 2 of this Article on the communication network referred to in Article 14 as appropriate. Article 16 Technical standards for information exchange The Agency shall develop technical standards in cooperation with the Member States in order to: (a) interconnect the communication network referred to in Article 14 with national networks used for establishing the national situational pictures referred to in Article 25 and other relevant information systems for the purpose of this Regulation; (b) develop, and establish interfaces between, relevant information exchange systems and software applications of the Agency and of the Member States for the purpose of this Regulation; (c) broadcast situational pictures and, as appropriate, specific situational pictures as referred to in Article 27 and ensure communication between relevant units and centres of competent national authorities and with the teams deployed by the Agency by using various means of communication such as satellite communications and radio networks; (d) report the position of own assets, making the best possible use of the technological development of the satellite navigation system established under the Galileo programme in accordance with Regulation (EU) No 1285/2013 of the European Parliament and of the Council (38). Article 17 Information assurance Member States shall ensure via their national coordination centre and under the supervision of the competent national authorities that their national authorities, agencies and other bodies, when using the communication network referred to in Article 14 and the information exchange systems of the Agency: (a) have proper and continuous access to the relevant systems and networks of the Agency or to systems and networks connected to them; (b) comply with the relevant technical standards referred to in Article 16; (c) apply equivalent security rules and standards as those applied by the Agency for the handling of classified information; (d) exchange, process and store sensitive non-classified and classified information in compliance with Article 92. SECTION 3 EUROSUR Article 18 EUROSUR This Regulation establishes EUROSUR as an integrated framework for the exchange of information and for operational cooperation within the European Border and Coast Guard in order to improve situational awareness and to increase reaction capability for the purposes of border management, including the detection, prevention and combating of illegal immigration and cross-border crime and contributing to ensuring the protection and saving the lives of migrants. Article 19 Scope of EUROSUR 1. EUROSUR shall be used for border checks at authorised border crossing points and for external land, sea and air border surveillance, including the monitoring, detection, identification, tracking, prevention and interception of unauthorised border crossings for the purpose of detecting, preventing and combating illegal immigration and cross-border crime and contributing to ensuring the protection and saving the lives of migrants. 2. EUROSUR shall not be used for any legal or administrative measure taken once the competent authorities of a Member State have intercepted cross-border criminal activities or unauthorised crossings by persons of the external borders. Article 20 EUROSUR components 1. Member States and the Agency shall use EUROSUR for the exchange of information and for the cooperation in the field of border control, taking into account existing information exchange and cooperation mechanisms. EUROSUR shall consist of the following components: (a) national coordination centres as referred to in Article 21; (b) national situational pictures as referred to in Article 25; (c) a European situational picture as referred to in Article 26, including information on external border sections with corresponding impact levels; (d) specific situational pictures as referred to in Article 27; (e) EUROSUR fusion services as referred to in Article 28; (f) integrated planning as referred to in Article 9. 2. The national coordination centres shall provide the Agency, via the communication network referred to in Article 14 and relevant systems, with information from their national situational pictures and, as appropriate, from specific situational pictures, which is required for the establishment and maintenance of the European situational picture. 3. The Agency shall give the national coordination centres, via the communication network, unlimited access twenty-four hours a day, seven days a week, to specific situational pictures and to the European situational picture. Article 21 National coordination centres 1. Each Member State shall designate, operate and maintain a national coordination centre which shall coordinate, and exchange information among, all authorities having responsibility for external border control at national level, as well as with the other national coordination centres and the Agency. Each Member State shall notify the establishment of its national coordination centre to the Commission, which shall forthwith inform the other Member States and the Agency thereof. 2. Without prejudice to Article 13 and within the framework of EUROSUR, the national coordination centre shall be the single point of contact for the exchange of information and for the cooperation with other national coordination centres and with the Agency. 3. The national coordination centres shall: (a) ensure the timely exchange of information and timely cooperation between all national authorities having responsibility for external border control at national level, as well as with other national coordination centres and the Agency; (b) ensure the timely exchange of information with search and rescue, law enforcement, asylum and immigration authorities and manage the dissemination of relevant information at national level; (c) contribute to an effective and efficient management of resources and personnel; (d) establish and maintain the national situational pictures in accordance with Article 25; (e) support the coordination, planning and implementation of national border control; (f) coordinate the national border control systems, in accordance with national law; (g) contribute to regularly measuring the effects of national border control for the purposes of this Regulation; (h) coordinate operational measures with other Member States and third countries, without prejudice to the competences of the Agency and of the other Member States; (i) exchange relevant information with the immigration liaison officers of their Member State, where designated, through appropriate structures established at national level, with a view to contributing to the European situational picture and supporting border control operations; (j) under the supervision of the competent national authorities, contribute to the information assurance of national information systems and the Agency's information systems. 4. Member States may charge regional, local, functional or other authorities which are in a position to take operational decisions with ensuring situational awareness and reaction capability in their respective areas of competence, including the tasks and competences listed in points (c), (e) and (f) of paragraph 3. 5. The decision of a Member State to allocate tasks in accordance with paragraph 4 shall not affect the national coordination centre in its ability to cooperate and exchange information with other national coordination centres and the Agency. 6. In pre-defined cases, as determined at national level, a national coordination centre may authorise an authority referred to in paragraph 4 to communicate and exchange information with the regional authorities or the national coordination centre of another Member State or the competent authorities of a third country on condition that such authorised authority regularly informs its own national coordination centre of such communication and exchange of information. 7. The national coordination centre shall operate twenty-four hours a day, seven days a week. Article 22 EUROSUR Handbook 1. The Commission shall, in close cooperation with the Agency and any other relevant Union body, office or agency, adopt and make available a practical handbook for the implementation and management of EUROSUR (the \u2018EUROSUR Handbook\u2019). The EUROSUR Handbook shall provide technical and operational guidelines, recommendations and best practices, including in relation to cooperation with third countries. The Commission shall adopt the EUROSUR Handbook in the form of a recommendation. 2. The Commission may decide, after consultation with Member States and the Agency, to classify parts of the EUROSUR Handbook as RESTREINT UE/EU RESTRICTED in compliance with the rules laid down in the Rules of Procedure of the Commission. Article 23 Monitoring of EUROSUR 1. The Agency and the Member States shall ensure that procedures are in place to monitor the technical and operational functioning of EUROSUR against the objectives of achieving an adequate situational awareness and reaction capability at the external borders. 2. The Agency shall continuously monitor the quality of the service offered by the communication network referred to in Article 14 and the quality of the data shared in the European situational picture. 3. The Agency shall transmit information collected as part of the monitoring under paragraph 2 to the national coordination centres and the relevant command and control structures used for the Agency's operations as part of the EUROSUR fusion services. Such information shall be classified RESTREINT UE/EU RESTRICTED. SECTION 4 Situational awareness Article 24 Situational pictures 1. The national situational pictures, the European situational picture and the specific situational pictures shall be produced through the collection, evaluation, collation, analysis, interpretation, generation, visualisation and dissemination of information. The situational pictures referred to in the first subparagraph shall consist of the following information layers: (a) an events layer that includes events and incidents related to unauthorised border crossings and cross-border crime and, where available, information on unauthorised secondary movements, for the purpose of understanding migratory trends, volume and routes; (b) an operational layer that contains information on operations, including the deployment plan, area of operations, and the position, time, status and type of assets participating as provided for in the operational plan; (c) an analysis layer that contains analysed information which is relevant for the purposes of this Regulation and, in particular, is relevant to the attribution of impact levels to the external border sections, such as imagery and geo-data, key developments and indicators, analytical reports, and other relevant supporting information. 2. The situational pictures referred to in paragraph 1 shall allow for the identification and tracing of events, operations and corresponding analysis relating to situations where human lives are at risk. 3. The Commission shall adopt an implementing act laying down the details of the information layers of the situational pictures and the rules for the establishment of specific situational pictures. The implementing act shall specify the type of information to be provided, the entities responsible for collecting, processing, archiving and transmitting specific information, the maximum time limits for reporting, the data security and data protection rules and related quality control mechanisms. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 122(2). Article 25 National situational pictures 1. Each national coordination centre shall establish and maintain a national situational picture in order to provide all authorities having responsibility for external border control at national level with effective, accurate and timely information. 2. The national situational picture shall be composed of information collected from the following sources: (a) the national border surveillance system in accordance with national law; (b) stationary and mobile sensors operated by national authorities having responsibility for external border surveillance; (c) patrols on border surveillance and other monitoring missions; (d) local, regional and other coordination centres; (e) other relevant national authorities and systems, including immigration liaison officers, operational centres and contact points; (f) border checks; (g) the Agency; (h) national coordination centres in other Member States; (i) authorities of third countries, on the basis of bilateral or multilateral agreements and regional networks referred to in Article 72; (j) ship reporting systems in accordance with their respective legal bases; (k) other relevant European and international organisations (l) other sources. 3. Each national coordination centre shall attribute a single indicative impact level, ranging from \u2018low\u2019 and \u2018medium\u2019 to \u2018high\u2019 and \u2018very high\u2019, to each incident in the events layer of the national situational picture. All incidents shall be shared with the Agency. 4. Each national coordination centre may decide, at the request of the competent national authorities, to restrict access to information related to national security, including military assets, on a need-to-know basis. 5. The national coordination centres of neighbouring Member States may share with each other, directly and in near real time, the situational picture of neighbouring external border sections, including the positions, status and type of own assets operating in the neighbouring external border sections. Article 26 European situational picture 1. The Agency shall establish and maintain a European situational picture in order to provide the national coordination centres and the Commission with effective, accurate and timely information and analysis, covering the external borders, the pre-frontier area and unauthorised secondary movements. 2. The European situational picture shall be composed of information collected from the following sources: (a) national coordination centres, and national situational pictures and information and reports received from immigration liaison officers to the extent required by this Article; (b) the Agency, including the information and reports provided by its liaison officers in accordance with Articles 31 and 77; (c) Union delegations and Common Security and Defence Policy (CSDP) missions and operations as provided for in point (j) of the second subparagraph of Article 68(1); (d) other relevant Union bodies, offices and agencies and international organisations listed in Article 68(1); (e) authorities of third countries, on the basis of bilateral or multilateral agreements and regional networks as referred to in Article 72, and working arrangements as referred to in Article 73(4); (f) other sources. 3. The events layer of the European situational picture shall include information relating to: (a) incidents and other events contained in the events layer of the national situational pictures; (b) incidents and other events contained in the specific situational pictures as provided for in Article 27; (c) incidents in the operational area of a joint operation or rapid intervention coordinated by the Agency, or in a hotspot. 4. The operational layer of the European situational picture shall contain information on the joint operations and rapid interventions coordinated by the Agency and on hotspots, and shall include the mission statements, locations, status, duration, information on the Member States and other actors involved, daily and weekly situational reports, statistical data and information packages for the media. 5. Information on own assets in the operational layer of the European situational picture may, where appropriate, be classified as RESTREINT UE/EU RESTRICTED. 6. In the European situational picture, the Agency shall take into account the impact levels that were assigned to specific incidents in national situational pictures by the national coordination centres. For any incident in the pre-frontier area, the Agency shall assign a single indicative impact level and shall inform the national coordination centres thereof. Article 27 Specific situational pictures 1. The Agency and the Member States may establish and maintain specific situational pictures in order to support specific operational activities at the external borders or to share information with Union institutions, bodies, offices and agencies and international organisations listed in Article 68(1) or third countries as provided for in Article 75. 2. The specific situational pictures shall be composed of a subset of information of the national and European situational pictures. 3. The detailed rules for establishing and sharing the specific situational pictures shall be set out in an operational plan for the operational activities concerned and in a bilateral or multilateral agreement where a specific situational picture is established in the framework of bilateral or multilateral cooperation with third countries. Any sharing of information under this paragraph shall be carried out in accordance with the principle of originator's consent. Article 28 EUROSUR fusion services 1. The Agency shall coordinate the EUROSUR Fusion Services in order to supply the national coordination centres, the Commission and itself with information on the external borders and on the pre-frontier area on a regular, reliable and cost-efficient basis. 2. The Agency shall provide a national coordination centre, at its request, with information on the external borders of the Member State to which it belongs and on the pre-frontier area which may be derived from: (a) the selective monitoring of designated third-country ports and coasts which have been identified through risk analysis and information as being embarkation or transit points for vessels or other craft used for illegal immigration or cross-border crime; (b) the tracking of vessels or other craft over high seas and the tracking of aircraft, where those vessels, other craft or aircraft are suspected of, or have been identified as, being used for illegal immigration or cross-border crime, including in the case of persons in distress at sea, with a view to transmitting that information to the relevant authorities that are competent for search and rescue operations; (c) monitoring of designated areas in the maritime domain in order to detect, identify and track vessels and other craft being used for, or suspected of being used for, illegal immigration or cross-border crime, including in the case of persons in distress at sea with a view to transmitting that information to the relevant authorities that are competent for search and rescue operations; (d) monitoring of designated areas of air borders in order to detect, identify and track aircraft and other forms of equipment being used for, or suspected of being used for, illegal immigration or cross-border crime; (e) environmental assessment of designated areas in the maritime domain and at the external land and air borders in order to optimise monitoring and patrolling activities; (f) selective monitoring of designated pre-frontier areas at the external borders which have been identified through risk analysis and information as being potential departure or transit areas for illegal immigration or cross-border crime; (g) monitoring migratory flows towards and within the Union in terms of trends, volume and routes; (h) media monitoring, open source intelligence and analysis of internet activities in line with Directive (EU) 2016/680 or Regulation (EU) 2016/679, as applicable, for the purpose of preventing illegal immigration or cross-border crime; (i) analysis of information derived from large-scale information systems for the purpose of detecting changing routes and methods used for illegal immigration and cross-border crime. 3. The Agency may refuse a request from a national coordination centre for technical, financial or operational reasons. The Agency shall notify the national coordination centre in due time of the reasons for such a refusal. 4. The Agency may use, on its own initiative, the surveillance tools referred to in paragraph 2 for collecting information on the pre-frontier area, which is relevant for the European situational picture. SECTION 5 Risk analysis Article 29 Risk analysis 1. The Agency shall monitor migratory flows towards the Union, and within the Union in terms of migratory trends, volume and routes, and other trends or possible challenges at the external borders and with regard to return. For that purpose, the Agency shall, by a decision of the management board based on a proposal from the executive director, establish a common integrated risk analysis model, which shall be applied by the Agency and the Member States. The common integrated risk analysis model shall be established and updated, where needed, on the basis of the outcome of the evaluation of the implementation of the multiannual strategic policy cycle for European integrated border management referred to in Article 8(7). 2. The Agency shall prepare general annual risk analyses, which shall be submitted to the European Parliament, to the Council and to the Commission applying the security rules adopted in accordance with Article 92, and tailored risk analyses for operational activities. Every two years, the Agency, in close consultation with the Member States, shall prepare and submit to the European Parliament, to the Council and to the Commission a strategic risk analysis for European integrated border management. Such strategic risk analyses shall be taken into account for the preparation of the multiannual strategic policy cycle for European integrated border management. The Agency shall prepare such general annual risk analyses and strategic risk analyses on the basis of information received, including from the Member States. Personal data shall be anonymised in the results of such risk analyses. 3. The risk analyses referred to in paragraph 2 shall cover all aspects relevant to European integrated border management with a view to developing a pre-warning mechanism. 4. The Agency shall publish comprehensive information on the common integrated risk analysis model. 5. Member States shall provide the Agency with all necessary information regarding the situation, trends and possible threats at the external borders and in the field of return. Member States shall regularly, or upon the request of the Agency, provide it with all relevant information such as statistical and operational data collected in relation to European integrated border management that is included in the list of mandatory information and data to be exchanged with the Agency as referred to in point (e) of Article 100(2), as well as information from the analysis layers of the national situational pictures as provided for in Article 25. 6. The results of the risk analysis shall be submitted to the management board and shared with the competent authorities of the Member States in a timely and accurate manner. 7. Member States shall take results of the risk analysis into account when planning their operations and activities at the external borders and their activities with regard to return. 8. The Agency shall incorporate the results of a common integrated risk analysis model in its development of common core curricula for training as referred to in Article 62. SECTION 6 Prevention and responsiveness Article 30 Determination of external border sections For the purposes of this Regulation, each Member State shall divide its external borders into external border sections. Those sections shall consist of land, sea and, where a Member State so decides, air border sections. Each Member State shall notify such external border sections to the Agency. Member States shall notify any change of external border sections to the Agency in a timely manner to ensure the continuity of risk analysis by the Agency. Article 31 Agency liaison officers in Member States 1. The Agency shall ensure the regular monitoring of all Member States' management of the external borders and return through liaison officers of the Agency. The Agency may decide that a liaison officer covers up to four Member States which are geographically close to each other. 2. The executive director shall appoint experts from the statutory staff to be deployed as liaison officers. The executive director shall, on the basis of risk analysis and in consultation with the Member States concerned, make a proposal on the nature and terms of the deployment, the Member State or region to which a liaison officer may be deployed and possible tasks not covered by paragraph 3. The proposal from the executive director shall be subject to approval by the management board. The executive director shall notify the Member State concerned of the appointment and shall determine, together with that Member State, the location of deployment. 3. The liaison officers shall act on behalf of the Agency, and their role shall be to foster cooperation and dialogue between the Agency and the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return. The liaison officers shall, in particular: (a) act as an interface between the Agency and the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return; (b) support the collection of information required by the Agency for the monitoring of illegal immigration and risk analyses referred to in Article 29; (c) support the collection of information referred to in Article 32 and required by the Agency to carry out vulnerability assessments and prepare a report for that purpose; (d) monitor the measures taken by the Member State at external border sections to which a high or critical impact level has been attributed in accordance with Article 34; (e) contribute to promoting the application of the Union acquis relating to the management of the external borders and return, including with regard to respect for fundamental rights; (f) cooperate with the fundamental rights officer, where necessary, with a view to promoting respect for fundamental rights in the work of the Agency in line with point (e); (g) where possible, assist the Member States in preparing their contingency plans concerning border management; (h) facilitate the communication between the Member State concerned and the Agency, share relevant information from the Agency with the Member State concerned, including information about ongoing operations; (i) report regularly and directly to the executive director on the situation at the external borders and the capacity of the Member State concerned to deal effectively with the situation at the external borders; report also on the execution of return operations towards relevant third countries; (j) monitor the measures taken by the Member State with regard to a situation requiring urgent action at the external borders as referred to in Article 42; (k) monitor the measures taken by the Member State with regard to return and support the collection of information required by the Agency to carry out the activities referred to in Article 48. 4. If the reporting by the liaison officer referred to in point (i) of paragraph 3 raises concerns about one or more aspects relevant for the Member State concerned, the executive director shall inform that Member State without delay. 5. For the purposes of paragraph 3, the liaison officer shall, in compliance with the national and Union security and data protection rules: (a) receive information from the national coordination centre concerned and the relevant national situational picture established in accordance with Article 25; (b) keep regular contacts with national authorities which are responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return, whilst informing the national contact point concerned. 6. The report of the liaison officer referred to in point (c) of paragraph 3 of this Article shall form part of the vulnerability assessment referred to in Article 32. The report shall be transmitted to the Member State concerned. 7. In carrying out their duties, the liaison officers shall take instructions only from the Agency. Article 32 Vulnerability assessment 1. The Agency shall establish a common vulnerability assessment methodology by decision of the management board, on the basis of a proposal from the executive director prepared in close cooperation with the Member States and the Commission. That methodology shall include objective criteria against which the Agency shall carry out the vulnerability assessment, the frequency of such assessments, how consecutive vulnerability assessments are to be carried out, and arrangements for an effective system for monitoring the implementation of recommendations of the executive director as referred to in paragraph 7. 2. The Agency shall monitor and assess the availability of the technical equipment, systems, capabilities, resources, infrastructure and adequately skilled and trained staff of Member States necessary for border control as referred to in point (a) of Article 3(1). In that context, the Agency shall assess the national capability development plans referred to in Article 9(4) as regards the capacity to perform border control taking into account the fact that some national capabilities may be partially used for purposes other than border control. For future planning, the Agency shall carry out such monitoring and assessment as a preventive measure on the basis of the risk analyses prepared in accordance with Article 29(2). The Agency shall carry out such monitoring and assessment at least once a year, unless the executive director, on the basis of risk analysis or a previous vulnerability assessment, decides otherwise. In any event, each Member State shall be subject to monitoring and assessment at least once every three years. 3. Without prejudice to Article 9, Member States shall, at the request of the Agency, provide information as regards technical equipment, staff and, to the extent possible, the financial resources available at national level to carry out border control. Member States shall also provide information on their contingency plans on border management at the Agency's request. 4. The aim of the vulnerability assessment is for the Agency: to assess the capacity and readiness of Member States to face present and upcoming challenges at the external borders; to identify, especially for those Member States facing specific and disproportionate challenges, possible immediate consequences at the external borders and subsequent consequences on the functioning of the Schengen area; to assess their capacity to contribute to the standing corps and to the technical equipment pool, including the rapid reaction equipment pool; and to assess the hosting capacity of Member States with regard to support from the European Border and Coast Guard in line with Article 9(3). That assessment shall be without prejudice to the Schengen evaluation mechanism. 5. In the vulnerability assessment, the Agency shall assess, in qualitative and quantitative terms, the Member States' capacity to carry out all border management tasks, including their capacity to deal with the potential arrival of large numbers of persons on their territory. 6. The preliminary results of the vulnerability assessment shall be submitted to the Member States concerned. The Member States concerned may comment on that assessment. 7. Where necessary, the executive director, in consultation with the Member State concerned, shall make a recommendation setting out the necessary measures to be taken by the Member State concerned and the time limit within which such measures are to be implemented. The executive director shall invite the Member States concerned to take the necessary measures on the basis of an action plan developed by the Member State in consultation with the executive director. 8. The executive director shall base the measures to be recommended to the Member States concerned on the results of the vulnerability assessment, taking into account the Agency's risk analysis, the comments of the Member State concerned and the results of the Schengen evaluation mechanism. The recommended measures shall be aimed at eliminating the vulnerabilities identified in the assessment in order for Member States to increase their readiness to face present and upcoming challenges at the external borders by enhancing or improving their capabilities, technical equipment, systems, resources and contingency plans. The executive director may offer the technical expertise of the Agency to the Member States to support the implementation of the recommended measures. 9. The executive director shall monitor the implementation of the recommended measures by means of regular reports to be submitted by the Member States on the basis of the action plans referred to in paragraph 7. Where there is a risk that a Member State will not implement a recommended measure within the time limit set in accordance with paragraph 7, the executive director shall immediately inform the member of the management board from the Member State concerned and the Commission. In consultation with the member of the management board from the Member State concerned, the executive director shall enquire of the relevant authorities of that Member State about the reasons for the delay and offer support by the Agency to facilitate the implementation of the measure recommended. 10. Where a Member State does not implement the necessary measures of the recommendation within the time limit set in accordance with paragraph 7 of this Article, the executive director shall refer the matter to the management board and notify the Commission. The management board shall adopt a decision on the basis of a proposal from the executive director, setting out the necessary measures to be taken by the Member State concerned and the time limit within which such measures are to be implemented. The decision of the management board shall be binding on the Member State. If the Member State does not implement the measures within the time limit provided for in that decision, the management board shall notify the Council and the Commission and further action may be taken in accordance with Article 42. 11. The vulnerability assessment, including a detailed description of the outcome of the vulnerability assessment, the measures taken by the Member States in response to the vulnerability assessment and the status of the implementation of any measures previously recommended, shall be transmitted, in accordance with Article 92, on a regular basis and at least once a year to the European Parliament, to the Council and to the Commission. Article 33 Synergies between the vulnerability assessment and the Schengen evaluation mechanism 1. The synergies between the vulnerability assessment and the Schengen evaluation mechanism shall be maximised in order to establish an improved situational picture on the functioning of the Schengen area, avoiding, to the extent possible, the duplication of efforts on the Member States' side, and ensuring a better coordinated use of the relevant Union financial instruments supporting the management of the external borders. 2. For the purpose referred to in paragraph 1, the Commission and the Agency shall establish the necessary arrangements to share with each other in a regular, secured and timely manner all information related to the results of vulnerability assessments and the results of the evaluations carried out within the framework of the Schengen evaluation mechanism in the area of border management. Those information-sharing arrangements shall cover the reports of vulnerability assessments and reports of Schengen evaluation visits, subsequent recommendations, action plans and any updates on the implementation of the action plans provided by the Member States. 3. For the purposes of the Schengen evaluation mechanism as it relates to external border management, the Commission shall share the results of the vulnerability assessments with all the members of the Schengen evaluation teams involved in the evaluation of the Member State concerned. Such information shall be considered sensitive within the meaning of Regulation (EU) No 1053/2013 and shall be treated accordingly. 4. The arrangements referred to in paragraph 2 shall cover results of the evaluations carried out within the framework of the Schengen evaluation mechanism in the area of return to ensure the full awareness of the Agency of the identified deficiencies in view of enabling it to propose appropriate measures to support Member States concerned in that regard. Article 34 Attribution of impact levels to external border sections 1. On the basis of the Agency's risk analysis and vulnerability assessment and in agreement with the Member State concerned, the Agency shall attribute the following impact levels to each external border section or change such levels: (a) low impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have an insignificant impact on border security; (b) medium impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have a moderate impact on border security; (c) high impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have a significant impact on border security. 2. In order to swiftly address a crisis situation at a particular external border section, where the Agency's risk analysis shows that incidents related to illegal immigration or cross-border crime occurring at the relevant external border section have a decisive impact on border security to such an extent that they risk jeopardising the functioning of the Schengen area, the Agency shall, in agreement with the Member State concerned, temporarily attribute a \u2018critical\u2019 impact level to that external border section. 3. Where there is no agreement between the Member State concerned and the Agency on the attribution of an impact level to an external border section, the impact level that was previously attributed to that border section shall remain unchanged. 4. The national coordination centre shall constantly assess in close cooperation with other competent national authorities whether there is a need to change the impact level of any of the external border sections by taking into account the information contained in the national situational picture and inform the Agency accordingly. 5. The Agency shall indicate the impact levels attributed to the external border sections in the European situational picture. Article 35 Reaction corresponding to impact levels 1. The Member States shall ensure that border control at the external border sections corresponds to the attributed impact levels in the following manner: (a) where a low impact level is attributed to an external border section, the national authorities responsible for external border control shall organise regular border control on the basis of risk analysis and ensure that sufficient personnel and resources are being kept available for that border section; (b) where a medium impact level is attributed to an external border section, the national authorities responsible for external border control shall, in addition to the measures taken under point (a) of this paragraph, ensure that appropriate border control measures are being taken at that border section; where such border control measures are taken, the national coordination centre shall be notified accordingly; the national coordination centre shall coordinate any support given in accordance with Article 21(3); (c) where a high impact level is attributed to an external border section, the Member State concerned, in addition to the measures taken under point (b) of this paragraph, shall ensure, through the national coordination centre, that the national authorities operating at that border section are given the necessary support and that reinforced border control measures are taken; that Member State may request support from the Agency subject to the conditions for initiating joint operations or rapid border interventions as laid down in Article 36; (d) where a critical impact level is attributed to an external border section, the Agency shall notify the Commission thereof; the executive director, in addition to the measures taken under point (c) of this paragraph, shall issue a recommendation in accordance with Article 41(1), taking into account the ongoing support by the Agency; the Member State concerned shall respond to the recommendation in accordance with Article 41(2). 2. The national coordination centres shall regularly inform the Agency of the measures taken at national level pursuant to points (c) and (d) of paragraph 1. 3. Where a medium, high or critical impact level is attributed to an external border section which is adjacent to the border section of another Member State or of a third country with which agreements, arrangements or regional networks, as referred to in Articles 72 and 73, are in place, the national coordination centre shall contact the national coordination centre of the neighbouring Member State or the competent authority of the neighbouring third country and shall endeavour to coordinate together with the Agency the necessary cross-border measures. 4. The Agency shall, together with the Member State concerned, evaluate the attribution of impact levels and the corresponding measures taken at national and Union level. That evaluation shall contribute to the vulnerability assessment to be carried out by the Agency in accordance with Article 32. SECTION 7 Action by the Agency at the external borders Article 36 Actions by the Agency at the external borders 1. A Member State may request the Agency's assistance in implementing its obligations with regard to external border control. The Agency shall also carry out measures in accordance with Articles 41 and 42. 2. The Agency shall organise the appropriate technical and operational assistance for the host Member State and it may, acting in accordance with the relevant Union and international law, including the principle of non-refoulement, take one or more of the following measures: (a) coordinate joint operations for one or more Member States and deploy the standing corps and technical equipment; (b) organise rapid border interventions and deploy the standing corps and technical equipment; (c) coordinate activities for one or more Member States and third countries at the external borders, including joint operations with third countries; (d) deploy the standing corps in the framework of the migration management support teams to, inter alia, hotspot areas in order to provide technical and operational assistance, including, where necessary, in return activities; (e) within the framework of operations referred to in points (a), (b) and (c) of this paragraph and in accordance with Regulation (EU) No 656/2014 and international law, provide technical and operational assistance to Member States and third countries in support of search and rescue operations for persons in distress at sea which may arise during border surveillance operations at sea; (f) give priority treatment to the EUROSUR fusion services. 3. The Agency shall finance or co-finance the activities referred to in paragraph 2 from its budget in accordance with the financial rules applicable to the Agency. 4. If the Agency has substantial additional financial needs due to a situation at the external borders, it shall inform the European Parliament, the Council and the Commission thereof without delay. Article 37 Initiating joint operations and rapid border interventions at the external borders 1. A Member State may request that the Agency launch joint operations to face upcoming challenges, including illegal immigration, present or future threats at its external borders or cross-border crime, or provide increased technical and operational assistance when implementing its obligations with regard to external border control. As part of such a request, a Member State may also indicate the profiles of operational staff needed for the joint operation in question, including those staff having executive powers, as applicable. 2. At the request of a Member State faced with a situation of specific and disproportionate challenges, especially the arrival at points of the external borders of large numbers of third-country nationals trying to enter the territory of that Member State without authorisation, the Agency may deploy a rapid border intervention for a limited period of time on the territory of that host Member State. 3. The executive director shall evaluate, approve and coordinate proposals made by Member States for joint operations or rapid border interventions. Joint operations and rapid border interventions shall be preceded by a thorough reliable and up-to-date risk analysis, thereby enabling the Agency to set an order of priority for the proposed joint operations and rapid border interventions, taking into account the impact levels attributed to external border sections in accordance with Article 34 and the availability of resources. 4. The objectives of a joint operation or rapid border intervention may be achieved as part of a multipurpose operation. Such operations may involve coast guard functions and the prevention of cross-border crime, focusing on the fight against migrant smuggling or trafficking in human beings, and migration management, focusing on identification, registration, debriefing and return. Article 38 Operational plans for joint operations 1. In preparation of a joint operation the executive director, in cooperation with the host Member State, shall draw up a list of technical equipment, staff and profiles of staff needed, including those staff having executive powers, as applicable, to be authorised in accordance with Article 82(2). That list shall be drawn up taking into account the host Member State's available resources and the host Member State's request under Article 37. On the basis of those elements, the Agency shall define a package of technical and operational reinforcement as well as capacity-building activities to be included in the operational plan. 2. The executive director shall draw up an operational plan for joint operations at the external borders. The executive director and the host Member State, in close and timely consultation with the participating Member States, shall agree on the operational plan detailing the organisational and procedural aspects of the joint operation. 3. The operational plan shall be binding on the Agency, the host Member State and the participating Member States. It shall cover all aspects considered necessary for carrying out the joint operation, including the following: (a) description of the situation, with modus operandi and objectives of the deployment, including the operational aim; (b) the estimated time that the joint operation is expected to last in order to achieve its objectives; (c) the geographical area where the joint operation will take place; (d) a description of the tasks, including those requiring executive powers, responsibilities, including with regard to the respect for fundamental rights and data protection requirements, and special instructions for the teams, including on permissible consultation of databases and permissible service weapons, ammunition and equipment in the host Member State; (e) the composition of the teams as well as the deployment of other relevant staff; (f) command and control provisions, including the names and ranks of the border guards of the host Member State responsible for cooperating with the members of the teams and the Agency, in particular the names and ranks of those border guards who are in command during the period of deployment, and the place of the members of the teams in the chain of command; (g) the technical equipment to be deployed during the joint operation, including specific requirements such as conditions for use, requested crew, transport and other logistics, and financial provisions; (h) detailed provisions on immediate incident reporting by the Agency to the management board and to relevant national authorities; (i) a reporting and evaluation scheme containing benchmarks for the evaluation report, including with regard to the protection of fundamental rights, and final date of submission of the final evaluation report; (j) regarding sea operations, specific information on the application of the relevant jurisdiction and applicable law in the geographical area where the joint operation takes place, including references to national, international and Union law regarding interception, rescue at sea and disembarkation; in that regard the operational plan shall be established in accordance with Regulation (EU) No 656/2014; (k) the terms of cooperation with third countries, other Union bodies, offices and agencies or international organisations; (l) general instructions on how to ensure the safeguarding of fundamental rights during the operational activity of the Agency; (m) procedures whereby persons in need of international protection, victims of trafficking in human beings, unaccompanied minors and persons in a vulnerable situation are directed to the competent national authorities for appropriate assistance; (n) procedures setting out a mechanism to receive and transmit to the Agency complaints against any person participating in an operational activity of the Agency, including border guards or other relevant staff of the host Member State and members of the teams, alleging breaches of fundamental rights in the context of their participation in an operational activity of the Agency; (o) logistical arrangements, including information on working conditions and the environment of the areas in which the joint operation is to take place. 4. Any amendments to or adaptations of the operational plan shall require the agreement of the executive director and the host Member State, after consultation of the participating Member States. A copy of the amended or adapted operational plan shall immediately be sent by the Agency to the participating Member States. 5. This Article shall apply mutatis mutandis to all operations of the Agency. Article 39 Procedure for launching a rapid border intervention 1. A request by a Member State to launch a rapid border intervention shall include a description of the situation, possible aims and envisaged needs, and the profiles of staff needed, including those staff having executive powers, as applicable. If required, the executive director may immediately send experts from the Agency to assess the situation at the external borders of the Member State concerned. 2. The executive director shall immediately inform the management board of a Member State's request to launch a rapid border intervention. 3. When deciding on the request of a Member State, the executive director shall take into account the findings of the Agency's risk analyses and the analysis layer of the European situational picture as well as the outcome of the vulnerability assessment referred to in Article 32 and any other relevant information provided by the Member State concerned or another Member State. 4. The executive director shall immediately assess the possibilities for redeployment of available members of the teams within the standing corps, in particular statutory staff and staff seconded to the Agency by the Member States, present in other operational areas. The executive director shall also assess the additional need to deploy operational staff in accordance with Article 57 and, once staff within the required profiles have been exhausted, to activate the reserve for rapid reaction in accordance with Article 58. 5. The executive director shall take a decision on the request to launch a rapid border intervention within two working days from the date of receipt of the request. The executive director shall simultaneously notify the Member State concerned and the management board in writing of the decision. The decision shall state the main reasons on which it is based. 6. When taking the decision referred to in paragraph 5 of this Article, the executive director shall inform the Member States about the possibility of requesting additional operational staff in accordance with Article 57 and, where applicable, Article 58 by indicating possible numbers and profiles of staff to be provided by each Member State. 7. If the executive director decides to launch a rapid border intervention, he or she shall deploy available border management teams from the standing corps and equipment from the technical equipment pool in accordance with Article 64, and where necessary, he or she shall decide on the immediate reinforcement by one or more border management teams, in accordance with Article 57. 8. The executive director together with the host Member State shall draw up and agree upon an operational plan as referred to in Article 38(2) immediately and, in any event, no later than three working days from the date of the decision. 9. As soon as the operational plan has been agreed upon and provided to the Member States, the executive director shall immediately deploy the operational staff available through redeployments from other operational areas or other duties. 10. In parallel to the deployment referred to in paragraph 9, and where necessary to secure the immediate reinforcement of the border management teams redeployed from other areas or duties, the executive director shall request from each Member State the number and profiles of additional staff to be additionally deployed from their national lists for short-term deployments as referred to in Article 57. 11. If a situation arises where the border management teams referred to in paragraph 7 and the staff referred to in paragraph 10 of this Article are insufficient, the executive director may activate the reserve for rapid reaction by requesting from each Member State the number and profiles of additional staff to be deployed as provided for in Article 58. 12. The information referred to paragraphs 10 and 11 shall be provided in writing to the national contact points and shall indicate the date on which the deployments of staff from each category are to take place. A copy of the operational plan shall also be provided to the national contact points. 13. Member States shall ensure that the number and profiles of staff are immediately made available to the Agency to guarantee a complete deployment in accordance with Article 57 and, if applicable, Article 58. 14. The deployment of the first border management teams redeployed from other areas and other duties shall take place no later than five working days after the date on which the operational plan is agreed between the executive director and the host Member State. Additional deployment of border management teams shall take place, where necessary, no later than 12 working days after the date on which the operational plan is agreed. 15. Where the rapid border intervention is to take place, the executive director shall, in consultation with the management board, immediately consider the priorities with regard to the Agency's ongoing and planned joint operations at other external borders in order to provide for possible reallocation of resources to the areas of the external borders where a strengthened deployment is most needed. Article 40 Migration management support teams 1. Where a Member State faces disproportionate migratory challenges at particular hotspot areas of its external borders characterised by large inward mixed migratory flows, that Member State may request technical and operational reinforcement by migration management support teams composed of experts from relevant Union bodies, offices and agencies that shall operate in accordance with their mandates. That Member State shall submit a request for reinforcement and an assessment of its needs to the Commission. On the basis of that assessment of needs, the Commission shall transmit the request, as appropriate, to the Agency, to EASO, to Europol and to other relevant Union bodies, offices and agencies. 2. The relevant Union bodies, offices and agencies shall examine, in accordance with their respective mandates, the Member State's request for reinforcement and the assessment of its needs for the purpose of defining a comprehensive reinforcement package consisting of various activities coordinated by the relevant Union bodies, offices and agencies, to be agreed upon by the Member State concerned. The Commission shall coordinate that process. 3. The Commission, in cooperation with the host Member State and the relevant Union bodies, offices and agencies in accordance with their respective mandates, shall establish the terms of cooperation at the hotspot area and shall be responsible for the coordination of the activities of the migration management support teams. 4. The technical and operational reinforcement provided, with full respect for fundamental rights, by the standing corps in the framework of migration management support teams may include the provision of: (a) assistance, with full respect for fundamental rights, in the screening of third-country nationals arriving at the external borders, including the identification, registration, and debriefing of those third-country nationals and, where requested by the Member State, the fingerprinting of third-country nationals and providing information regarding the purpose of these procedures; (b) initial information to persons who wish to apply for international protection and the referral of those persons to the competent national authorities of the Member State concerned or to the experts deployed by EASO; (c) technical and operational assistance in the field of return in accordance with Article 48, including the preparation and organisation of return operations; (d) necessary technical equipment. 5. Migration management support teams shall include, where necessary, staff with expertise in child protection, trafficking in human beings, protection against gender-based persecution or fundamental rights. Article 41 Proposed actions at the external borders 1. On the basis of the results of the vulnerability assessment or where a critical impact level is attributed to one or more external border sections and taking into account the relevant elements in the Member State's contingency plans, the Agency's risk analysis and the analysis layer of the European situational picture, the executive director shall recommend to the Member State concerned to request that the Agency initiate, carry out or adjust joint operations, rapid border interventions or any other relevant actions by the Agency as set out in Article 36. 2. The Member State concerned shall respond to the recommendation of the executive director referred to in paragraph 1 within six working days. In the event of a negative response to the recommendation, the Member State shall also provide the justifications underlying that response. The executive director shall notify the management board and the Commission without delay about the recommended actions and the justifications for the negative response, with a view to assessing whether urgent action may be required in accordance with Article 42. Article 42 Situation at the external borders requiring urgent action 1. Where external border control is rendered ineffective to such an extent that it risks jeopardising the functioning of the Schengen area because: (a) a Member State does not implement the necessary measures in accordance with a decision of the management board referred to in Article 32(10); or (b) a Member State facing specific and disproportionate challenges at the external borders has either not requested sufficient support from the Agency under Article 37, 39 or 40 or is not taking the necessary steps to implement actions under those Articles or under Article 41; the Council, on the basis of a proposal from the Commission, may adopt without delay a decision by means of an implementing act to identify measures to mitigate those risks to be implemented by the Agency and requiring the Member State concerned to cooperate with the Agency in the implementation of those measures. The Commission shall consult the Agency before making its proposal. 2. Where a situation requiring urgent action arises, the European Parliament shall be informed of that situation without delay as well as of any subsequent measures and decisions taken in response. 3. To mitigate the risk of putting the Schengen area in jeopardy, the Council decision referred to in paragraph 1 shall provide for one or more of the following measures to be taken by the Agency: (a) organise and coordinate rapid border interventions and deploy the standing corps, including teams from the reserve for rapid reaction; (b) deploy the standing corps in the framework of the migration management support teams, in particular at hotspot areas; (c) coordinate activities for one or more Member States and third countries at the external borders, including joint operations with third countries; (d) deploy technical equipment; (e) organise return interventions. 4. The executive director shall, within two working days from the date of adoption of the Council decision referred to in paragraph 1: (a) determine the actions to be taken for the practical execution of the measures identified in that decision, including the technical equipment and the number and profiles of the operational staff needed to meet the objectives of that decision; (b) draw up a draft operational plan and submit it to the Member States concerned. 5. The executive director and the Member State concerned shall agree on the operational plan referred to in point (b) of paragraph 4 within three working days from the date of its submission. 6. The Agency shall, without delay, and in any case within five working days from the establishment of the operational plan, deploy the necessary operational staff from the standing corps for the practical execution of the measures identified in the Council decision referred to in paragraph 1. Additional teams shall be deployed as necessary at a second stage, and in any case within 12 working days from the establishment of the operational plan. 7. The Agency and the Member States shall, without delay, and in any case within 10 working days from the establishment of the operational plan, send the necessary technical equipment and competent staff to the destination of deployment for the practical execution of the measures identified in the Council decision referred to in paragraph 1. Additional technical equipment shall be deployed as necessary at a second stage in accordance with Article 64. 8. The Member State concerned shall comply with the Council decision referred to in paragraph 1. For that purpose, it shall immediately cooperate with the Agency and take the necessary action to facilitate the implementation of that decision and the practical execution of the measures set out in that decision and in the operational plan agreed upon with the executive director, in particular by implementing the obligations provided for in Articles 43, 82 and 83. 9. In accordance with Article 57 and, where relevant, Article 39, the Member States shall make available the operational staff determined by the executive director in accordance with paragraph 4 of this Article. 10. The Commission shall monitor the implementation of the measures identified in the Council decision referred to in paragraph 1 and the actions that the Agency takes for that purpose. If the Member State concerned does not comply with the Council decision referred to in paragraph 1 of this Article within 30 days and does not cooperate with the Agency in accordance with to paragraph 8 of this Article, the Commission may trigger the procedure provided for in Article 29 of Regulation (EU) 2016/399. Article 43 Instructions to the teams 1. During the deployment of border management teams, return teams and migration management support teams, the host Member State or, in the case of cooperation with a third country in accordance with a status agreement, the third country concerned, shall issue instructions to the teams in accordance with the operational plan. 2. The Agency, through its coordinating officer, may communicate its views to the host Member State on the instructions given to the teams. In that case, the host Member State shall take those views into consideration and follow them to the extent possible. 3. In cases where the instructions issued to the teams are not in compliance with the operational plan, the coordinating officer shall immediately report to the executive director, who may, if appropriate, take action in accordance with Article 46(3). 4. Members of the teams shall, in the performance of their tasks and in the exercise of their powers, fully respect fundamental rights, including access to asylum procedures and human dignity, and shall pay particular attention to vulnerable persons. Any measures taken in the performance of their tasks and in the exercise of their powers shall be proportionate to the objectives pursued by such measures. While performing their tasks and exercising their powers, they shall not discriminate against persons on the basis of any grounds such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation in line with Article 21 of the Charter. 5. Members of the teams who are not statutory staff shall remain subject to the disciplinary measures of their home Member State. The home Member State shall provide for appropriate disciplinary or other measures in accordance with its national law regarding violations of fundamental rights or international protection obligations in the course of any operational activity by the Agency. 6. Statutory staff deployed as members of the teams shall be subject to disciplinary measures as provided for in the Staff Regulations and the Conditions of Employment and measures of a disciplinary nature provided for in the supervisory mechanism referred to in point (a) of Article 55(5). Article 44 Coordinating officer 1. The Agency shall ensure the operational implementation of all the organisational aspects of joint operations, pilot projects or rapid border interventions, including the presence of statutory staff. 2. Without prejudice to Article 60, the executive director shall appoint one or more experts from the statutory staff to be deployed as a coordinating officer for each joint operation or rapid border intervention. The executive director shall notify the host Member State of the appointment. 3. The coordinating officer shall act on behalf of the Agency in all aspects of the deployment of the teams. The role of the coordinating officer shall be to foster cooperation and coordination among host and participating Member States. At least one fundamental rights monitor shall assist and advise the coordinating officer. In particular, the coordinating officer shall: (a) act as an interface between the Agency, the host Member State and the members of the teams, providing assistance, on behalf of the Agency, on all issues relating to the conditions of the deployment to the teams; (b) monitor the correct implementation of the operational plan, including, in cooperation with the fundamental rights monitors, as regards the protection of fundamental rights and report to the executive director on this; (c) act on behalf of the Agency in all aspects of the deployment of the teams and report to the Agency on all those aspects; (d) report to the executive director where the instructions issued to the teams by the host Member States are not in compliance with the operational plan, in particular as regards fundamental rights and, where appropriate, suggest that the executive director consider taking a decision in accordance with Article 46. 4. In the context of joint operations or rapid border interventions, the executive director may authorise the coordinating officer to assist in resolving any disagreement on the execution of the operational plan and deployment of the teams. Article 45 Costs 1. The Agency shall fully cover the following costs incurred by Member States in making available their staff for the purposes of deploying them from the standing corps as members of the teams to the Member States and to third countries for a short term in accordance with Article 57 or to the Member States through the reserve for rapid reaction in accordance with Article 58: (a) travel costs from the home Member State to the host Member State, from the host Member State to the home Member State, within the host Member State for the purposes of deployment or redeployment within that host Member State or to another host Member State, and for the purposes of deployments to, and redeployments within or to, another third country; (b) costs related to vaccinations; (c) costs related to special insurance needs; (d) costs related to health care, including psychological assistance; (e) daily subsistence allowances, including accommodation costs. 2. On the basis of a proposal of the executive director, the management board shall adopt detailed rules as regards the reimbursement of the costs incurred by staff deployed for a short term in accordance with Articles 57 and 58, and shall update them as necessary. To ensure compliance with the applicable legal framework, the executive director shall make such proposal after receiving the positive opinion of the Commission. The detailed rules shall be based to the extent possible on simplified cost options in accordance with points (c), (d) and (e) of Article 125(1) of Regulation (EU, Euratom) 2018/1046. Where relevant, the management board shall ensure consistency with the rules applicable to mission expenses of statutory staff. Article 46 Decisions to suspend, terminate or not launch activities 1. The executive director shall terminate any activity of the Agency if the conditions to conduct those activities are no longer fulfilled. The executive director shall inform the Member State concerned prior to such termination. 2. The Member States participating in an operational activity by the Agency may request that the executive director terminate that operational activity. The executive director shall inform the management board of such request. 3. The executive director may, after informing the Member State concerned, withdraw the financing of an activity or suspend or terminate it if the operational plan is not respected by the host Member State. 4. The executive director shall, after consulting the fundamental rights officer and informing the Member State concerned, withdraw the financing for any activity by the Agency, or suspend or terminate any activity by the Agency, in whole or in part, if he or she considers that there are violations of fundamental rights or international protection obligations related to the activity concerned that are of a serious nature or are likely to persist. 5. The executive director shall, after consulting the fundamental rights officer, decide not to launch any activity by the Agency where he or she considers that there would already be serious reasons at the beginning of the activity to suspend or terminate it because it could lead to violations of fundamental rights or international protection obligations of a serious nature. The executive director shall inform the Member State concerned of that decision. 6. The decisions referred to in paragraphs 4 and 5 shall be based on duly justified grounds. When taking such decisions, the executive director shall take into account relevant information such as the number and substance of registered complaints that have not been resolved by a national competent authority, reports of serious incidents, reports from coordinating officers, relevant international organisations and Union institutions, bodies, offices and agencies in the areas covered by this Regulation. The executive director shall inform the management board of such decisions and provide it with justifications therefor. 7. If the executive director decides to suspend or terminate deployment by the Agency of a migration management support team, he or she shall inform the other relevant bodies, offices and agencies active in the hotspot area of that decision. Article 47 Evaluation of activities The executive director shall evaluate the results of all the Agency's operational activities. He or she shall transmit detailed evaluation reports to the management board within 60 days following the end of those activities, together with the observations of the fundamental rights officer. The executive director shall make a comprehensive analysis of those results with a view to enhancing the quality, coherence and effectiveness of future activities, and shall include that analysis in the Agency's annual activity report. The executive director shall ensure that the Agency takes the analysis of those results into account in future operational activities. SECTION 8 Action by the Agency in the area of return Article 48 Return 1. Without entering into the merits of return decisions, which remain the sole responsibility of the Member States, and in accordance with the respect for fundamental rights, general principles of Union law and international law, including international protection, the respect for the principle of non-refoulement and children's rights, with regard to return, the Agency shall: (a) provide technical and operational assistance to Member States in the area of return, including in: (i) the collection of information necessary for issuing return decisions, the identification of third-country nationals subject to return procedures and other pre-return, return-related and post-arrival and post-return activities of the Member States, to achieve an integrated system of return management among competent authorities of the Member States, with the participation of relevant authorities of third countries and other relevant stakeholders; (ii) the acquisition of travel documents, including by means of consular cooperation, without disclosing information relating to the fact that an application for international protection has been made or any other information that is not necessary for the purpose of the return; (iii) the organisation and coordination of return operations and provide assistance in relation to voluntary returns in cooperation with the Member States; (iv) assisted voluntary returns from the Member States, providing assistance to returnees during the pre-return, return-related and post-arrival and post-return phases, taking into account the needs of vulnerable persons; (b) provide technical and operational assistance to Member States experiencing challenges with regard to their return systems; (c) develop, in consultation with the fundamental rights officer, a non-binding reference model for national IT systems for return case management which describes the structure of such systems, as well as provide technical and operational assistance to Member States in developing such systems compatible with the model; (d) operate and further develop an integrated return management platform and a communication infrastructure that enables the linking of the return management systems of the Member States with the platform for the purpose of exchanging data and information, including the automated transmission of statistical data, and provide technical and operational assistance to Member States in connecting to the communication infrastructure; (e) organise, promote and coordinate activities enabling the exchange of information and the identification and pooling of best practices in return matters between the Member States; (f) finance or co-finance from its budget, in accordance with the financial rules applicable to the Agency, the operations, interventions and activities referred to in this Chapter, including reimbursing the costs incurred for the necessary adaptation of the national IT systems for return case management for the purpose of ensuring secure communication to the integrated return management platform. 2. The technical and operational assistance referred to in point (b) of paragraph 1 shall include activities to help Member States carry out return procedures by the competent national authorities by providing, in particular: (a) interpreting services; (b) practical information, including the analysis of such information, and recommendations by the Agency on third countries of return relevant for the implementation of this Regulation, in cooperation, where appropriate, with other Union bodies, offices and agencies, in particular EASO; (c) advice on the implementation and management of return procedures in compliance with Directive 2008/115/EC; (d) advice on and assistance in the implementation of measures taken by Member States in compliance with Directive 2008/115/EC and international law that are necessary to ensure the availability of returnees for return purposes and to prevent returnees from absconding and advice on and assistance in relation to alternatives to detention; (e) equipment, resources and expertise for the implementation of return decisions and for the identification of third-country nationals. 3. The Agency shall aim at building synergies and connecting Union-funded networks and programmes in the field of return in close cooperation with the Commission and with the support of relevant stakeholders, including the European Migration Network. Article 49 Information exchange systems and management of return 1. The Agency shall operate and further develop, in accordance with point (d) of Article 48(1), an integrated return management platform for processing information, including personal data transmitted by the Member States' return management systems, that is necessary for the Agency to provide technical and operational assistance. Personal data shall only include biographic data or passenger lists. Personal data shall be transmitted only where they are necessary for the Agency to assist in the coordination or organisation of return operations to third countries, irrespective of the means of transport. Such personal data shall be transmitted to the platform only once a decision to launch a return operation has been taken, and shall be erased as soon as the operation is terminated. Biographic data shall only be transmitted to the platform where they cannot be accessed by members of teams in accordance with Article 17(3) of Regulation (EU) 2018/1860 of the European Parliament and of the Council (39). The Agency may also use the platform for the purpose of securely transmitting biographic or biometric data, including all types of documents which can be considered as proof or prima facie evidence of the nationality of third-country nationals subject to return decisions, where the transmission of such personal data is necessary for the Agency to provide assistance, at the request of a Member State, in confirming the identity and nationality of third-country nationals in individual cases. Such data shall not be stored on the platform and shall be erased immediately following a confirmation of receipt. 2. The Agency shall develop, deploy and operate information systems and software applications allowing for the exchange of information for the purpose of return within the European Border and Coast Guard and for the purpose of exchanging personal data. 3. Personal data shall be processed in accordance with Articles 86, 87, 88 and 91, as applicable. Article 50 Return operations 1. Without entering into the merits of return decisions, which remain the sole responsibility of the Member States, the Agency shall provide Member States with technical and operational assistance and shall ensure the coordination or the organisation of return operations, including through the chartering of aircraft for the purpose of such operations and organising returns on scheduled flights or by other means of transport. The Agency may, on its own initiative and with the agreement of the Member State concerned, coordinate or organise return operations. 2. Member States shall provide operational data on returns necessary for the assessment of return needs by the Agency through the platform referred to in Article 49(1) and shall inform the Agency of their indicative planning as regards the number of returnees and the third countries of return, both with respect to relevant national return operations, and of their needs for assistance or coordination by the Agency. The Agency shall draw up and maintain a rolling operational plan to provide the requesting Member States with the necessary operational assistance and reinforcements, including through technical equipment. The Agency may, either on its own initiative and with the agreement of the Member State concerned or at the request of a Member State, include in the rolling operational plan the dates and destinations of return operations it considers necessary, based on a needs assessment. The management board shall decide, on the basis of a proposal from the executive director, on the modus operandi of the rolling operational plan. The Member State concerned shall confirm to the Agency that all returnees covered by a return operation organised or coordinated by the Agency are the subject of an enforceable return decision. Where members of the teams are deployed, they shall consult the Schengen Information System prior to the return of any returnee in order to check whether the return decision issued in relation to that returnee has been suspended or whether its enforcement has been postponed. The rolling operational plan shall contain the elements necessary for carrying out a return operation, including those concerning the respect for fundamental rights, and shall refer to, inter alia, relevant codes of conduct and procedures for monitoring, reporting and the complaints mechanism. 3. The Agency may provide technical and operational assistance to the Member States and may also, either on its own initiative and with the agreement of the Member State concerned or at the request of the participating Member States, ensure the coordination or the organisation of return operations for which the means of transport and return escorts are provided by a third country of return (\u2018collecting return operations\u2019). The participating Member States and the Agency shall ensure that the respect for fundamental rights, the principle of non-refoulement, the proportionate use of means of constraints and the dignity of the returnee are guaranteed during the entire return operation. At least one Member State representative, and one forced-return monitor from the pool established under Article 51 or from the monitoring system of the participating Member State, shall be present throughout the entire return operation until arrival at the third country of return. 4. The executive director shall draw up a return plan for collecting return operations without delay. The executive director and any participating Member State shall agree on the plan detailing the organisational and procedural aspects of the collecting return operation, taking account of the implications for the fundamental rights and risks of such operations. Any amendment to or adaptation of that plan shall require the agreement of the parties referred to in paragraph 3 and in this paragraph. The return plan for collecting return operations shall be binding on the Agency and any participating Member State. It shall cover all the necessary steps for carrying out collecting return operations. 5. Every return operation organised or coordinated by the Agency shall be monitored in accordance with Article 8(6) of Directive 2008/115/EC. The monitoring of forced-return operations shall be carried out by the forced-return monitor on the basis of objective and transparent criteria and shall cover the whole return operation from the pre-departure phase until the handover of the returnees in the third country of return. The forced-return monitor shall submit a report on each forced-return operation to the executive director, the fundamental rights officer and to the competent national authorities of all the Member States involved in the given operation. If necessary, appropriate follow-up shall be ensured by the executive director and competent national authorities respectively. 6. If the Agency has concerns regarding the respect of fundamental rights at any stage of a return operation, it shall communicate them to the participating Member States and to the Commission. 7. The executive director shall evaluate the results of the return operations and shall transmit every six months a detailed evaluation report to the European Parliament, to the Council, to the Commission and to the management board covering all return operations conducted in the previous semester, together with the observations of the fundamental rights officer. The executive director shall make a comprehensive comparative analysis of those results with a view to enhancing the quality, coherence and effectiveness of future return operations. The executive director shall include that analysis in the Agency's annual activity report. 8. The Agency shall finance or co-finance return operations from its budget, in accordance with the financial rules applicable to the Agency, giving priority to those conducted by more than one Member State, or from hotspot areas. Article 51 Pool of forced-return monitors 1. The Agency shall, after taking due account of the opinion of the fundamental rights officer, constitute a pool of forced-return monitors from competent bodies of the Member States who carry out forced-return monitoring activities in accordance with Article 8(6) of Directive 2008/115/EC and who have been trained in accordance with Article 62 of this Regulation. 2. The management board shall, on the basis of a proposal from the executive director, determine the profile and the number of forced-return monitors to be made available to that pool. The same procedure shall apply with regard to any subsequent changes in the profile and overall numbers. Member States shall be responsible for contributing to the pool by nominating forced-return monitors corresponding to the defined profile, without prejudice to the independence of those monitors under national law, where national law so provides. The Agency shall also contribute fundamental rights monitors as referred to in Article 110 to the pool. Forced-return monitors with specific expertise in child protection shall be included in the pool. 3. Member States' contribution of forced-return monitors to return operations and interventions for the following year shall be planned on the basis of annual bilateral negotiations and agreements between the Agency and Member States. In accordance with those agreements, Member States shall make the forced-return monitors available for deployment at the request of the Agency, unless they are faced with an exceptional situation substantially affecting the discharge of national tasks. Such a request shall be made at least 21 working days before the intended deployment, or five working days in the case of a rapid return intervention. 4. The Agency shall make the forced-return monitors available upon request to participating Member States to monitor, on their behalf, the correct implementation of the return operations and return interventions throughout their duration. It shall make available forced-return monitors with specific expertise in child protection for any return operation involving children. 5. Forced-return monitors shall remain subject to the disciplinary measures of their home Member State in the course of a return operation or return intervention. Statutory staff deployed as forced-return monitors shall be subject to the disciplinary measures provided for in the Staff Regulations and the Conditions of Employment. Article 52 Return teams 1. The Agency may deploy return teams either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State. The Agency may deploy such return teams during return interventions, in the framework of migration management support teams or as necessary to provide additional technical and operational assistance in the area of return. Where necessary, return teams shall contain officers with specific expertise in child protection. 2. Article 40(2) to (5) and Articles 43, 44 and 45 shall apply mutatis mutandis to the return teams. Article 53 Return interventions 1. Where a Member State is facing a burden when implementing the obligation to return returnees, the Agency shall provide the appropriate technical and operational assistance in the form of a return intervention, either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State. Such intervention may consist in the deployment of return teams to the host Member State providing assistance in the implementation of return procedures and the organisation of return operations from the host Member State. Article 50 shall apply also to return operations organised or coordinated by the Agency in the framework of return interventions. 2. Where a Member State is facing specific and disproportionate challenges when implementing its obligation to return returnees, the Agency shall provide the appropriate technical and operational assistance in the form of a rapid return intervention, either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State. A rapid return intervention may consist in the rapid deployment of return teams to the host Member State providing assistance in the implementation of return procedures and the organisation of return operations from the host Member State. 3. In the context of a return intervention, the executive director shall draw up an operational plan without delay, in agreement with the host Member State and the participating Member States. The provisions of Article 38 shall apply mutatis mutandis. 4. The executive director shall take a decision on the operational plan as soon as possible and, in the case referred to in paragraph 2, within five working days. The decision shall be immediately notified, in writing, to the Member States concerned and to the management board. 5. The Agency shall finance or co-finance return interventions from its budget in accordance with the financial rules applicable to the Agency. SECTION 9 Capabilities Article 54 European Border and Coast Guard standing corps 1. A European Border and Coast Guard standing corps with the capacity set out in Annex I shall be part of the Agency. The standing corps shall be composed of the following four categories of operational staff in accordance with the annual availability scheme set out in Annex I: (a) category 1: statutory staff deployed as members of the teams in operational areas in accordance with Article 55, as well as staff responsible for the functioning of the ETIAS Central Unit; (b) category 2: staff seconded from Member States to the Agency for a long term as part of the standing corps in accordance with Article 56; (c) category 3: staff from Member States who are ready to be provided to the Agency for a short-term deployment as part of the standing corps in accordance with Article 57; and (d) category 4: the reserve for rapid reaction consisting of staff from the Member States who are ready to be deployed in accordance with Article 58 for the purposes of rapid border interventions in accordance with Article 39. 2. The Agency shall deploy members of the standing corps as members of the border management teams, migration management support teams and return teams in joint operations, rapid border interventions, return interventions or any other relevant operational activities in the Member States or in third countries. Such activities shall only be carried out with the authorisation of the Member State or the third country concerned. The actual number of staff deployed from the standing corps shall depend on the operational needs. Deployment of the standing corps shall be complementary to the efforts undertaken by the Member States. 3. When providing support to the Member States, the members of the standing corps deployed as members of the teams shall have the ability to carry out border control or return tasks, including tasks requiring executive powers provided for in the relevant national law or, in the case of statutory staff, the tasks requiring executive powers set out in Article 55(7). The members of the standing corps shall meet the requirements for specialised training and professionalism as provided for in the third subparagraph of Article 16(1) of Regulation (EU) 2016/399 or other relevant instruments. 4. On the basis of a proposal from the executive director taking into account the Agency's risk analysis, the results of the vulnerability assessment and the multiannual strategic policy cycle for European integrated border management, and building on the numbers and profiles of staff available to the Agency through its statutory staff and ongoing secondments, by 31 March of each year the management board shall adopt a decision: (a) defining the profiles of, and setting out the requirements for, operational staff; (b) on the number of staff per specific profile of categories 1, 2 and 3 staff to form teams in the following year, based on the expected operational needs for the following year; (c) specifying further the contributions set out in Annexes II and III by setting the specific numbers and profiles of staff per Member State to be seconded to the Agency in accordance with Article 56 and to be nominated in accordance with Article 57 in the following year; (d) specifying further the contributions set out in Annex IV by setting the specific numbers and profiles of staff per Member State under the reserve for rapid reaction to be provided in the following year in the event of rapid border interventions in accordance with Articles 39 and 58; and (e) setting out an indicative multiannual planning of profiles for the subsequent years to facilitate the long-term planning for the Member States' contributions and the recruitment of statutory staff. 5. The crew for technical equipment provided in accordance with Article 64 shall be taken into account as part of the contributions for short-term deployments provided by the Member States pursuant to Article 57 for the following year. With a view to preparing the relevant management board decision referred to in paragraph 4 of this Article, the Member State concerned shall inform the Agency about its intention to deploy the technical equipment with the corresponding crew by the end of January of each year. 6. For the purpose of Article 73, the Agency shall develop and ensure the command and control structures for the effective deployment of the standing corps on the territory of third countries. 7. The Agency may recruit a sufficient number of statutory staff, which may account for up to 4 % of the total number of the standing corps set out in Annex I, for supportive or monitoring functions for the establishment of the standing corps, for the planning and management of its operations and for the acquisition of the Agency's own equipment. 8. The staff referred to in paragraph 7 and the staff responsible for the functioning of the ETIAS Central Unit shall not be deployed as members of the teams, but shall nevertheless be counted as category 1 staff for the purposes of Annex I. Article 55 Statutory staff in the standing corps 1. The Agency shall contribute members of its statutory staff (category 1) to the standing corps to be deployed in operational areas as members of the teams with the tasks and powers provided for in Article 82, including the task of operating the Agency's own equipment. 2. When recruiting staff, the Agency shall ensure that only candidates who demonstrate a high level of professionalism, adhere to high ethical values and possess appropriate language skills are selected. 3. In accordance with Article 62(2), following their recruitment, the statutory staff to be deployed as members of the teams shall undergo necessary border-guard or return-related training, including on fundamental rights, as relevant to the profiles of staff decided by the management board in accordance with Article 54(4), taking into account their previously acquired qualifications and professional experience in the relevant areas. The training referred to in the first subparagraph shall be conducted in the framework of dedicated training programmes designed by the Agency, and, on the basis of agreements with selected Member States, implemented in their specialised institutions for training and education, including the Agency's partnership academies in Member States. Adequate training maps shall be designed for each staff member after his or her recruitment to ensure that he or she is always professionally qualified to fulfil border guard or return-related tasks. Training maps shall be regularly updated. The Agency shall cover the full cost of training. Statutory staff who act as technical crew operating the Agency's own equipment shall not need to undergo full border guard or return-related training. 4. Throughout their employment, the Agency shall ensure that its statutory staff discharge their duties as members of the teams in accordance with the highest standards and in full compliance with fundamental rights. 5. On the basis of a proposal from the executive director, the management board shall: (a) establish an appropriate supervisory mechanism to monitor the application of the provisions on use of force by statutory staff, including rules on reporting and specific measures, such as those of a disciplinary nature, with regard to the use of force during deployments; (b) establish rules for the executive director to authorise statutory staff to carry and use weapons in accordance with Article 82 and Annex V, including on mandatory cooperation with the competent national authorities, in particular of the Member State of nationality, the Member State of residence, and the Member State of the initial training; those rules shall also address how the executive director ensures that the conditions for issuing such authorisations continue to be met by statutory staff, in particular as regards handling weapons including the performance of regular shooting tests; (c) establish specific rules to facilitate the storage of weapons, ammunition and other equipment in secured facilities and their transportation to the operational areas. In relation to the rules referred to in point (a) of the first subparagraph of this paragraph, the Commission shall give an opinion on their compliance with the Staff Regulations and Conditions of Employment, in accordance with Article 110(2) of the Staff Regulations. The fundamental rights officer shall be consulted on the proposal from the executive director with regard to those rules. 6. Agency staff who are not qualified to perform border guard or return-related tasks shall only be deployed during joint operations for coordination, monitoring of fundamental rights and other related tasks. They shall not form part of the teams. 7. The statutory staff to be deployed as members of the teams shall be able to perform, in accordance with Article 82, the following tasks requiring executive powers, in accordance with the profiles of staff and relevant training: (a) the verification of the identity and nationality of persons, including consultation of relevant Union and national databases; (b) the authorisation of entry where the entry conditions, as laid down in Article 6 of Regulation (EU) 2016/399, are fulfilled; (c) the refusal of entry in accordance with Article 14 of Regulation (EU) 2016/399; (d) the stamping of travel documents in accordance with Article 11 of Regulation (EU) 2016/399; (e) the issuing or refusing of visas at the border in accordance with Article 35 of Regulation (EC) No 810/2009 of the European Parliament and of the Council (40) and introducing relevant data in the Visa Information System; (f) border surveillance, including patrolling between border crossing points to prevent unauthorised border crossings, to counter cross-border crime and to take measures against persons who have crossed the border illegally, including interception or apprehension; (g) the registering of fingerprints of persons apprehended in connection with the irregular crossing of an external border in Eurodac in accordance with Chapter III of Regulation (EU) No 603/2013 of the European Parliament and of the Council (41); (h) liaising with third countries with a view to identifying and obtaining travel documents for returnees; (i) escorting third-country nationals subject to forced-return procedures. Article 56 Member States' participation in the standing corps through long-term secondment 1. The Member States shall contribute to the standing corps by seconding operational staff to the Agency as members of the teams (category 2). The duration of individual secondments shall be 24 months. With the agreement of the home Member State and the Agency, individual secondments may be prolonged once for another 12 or 24 months. In order to facilitate the implementation of the financial support system referred to in Article 61, secondments shall, as a general rule, start at the beginning of a calendar year. 2. Each Member State shall be responsible for ensuring the continuous contribution of operational staff as seconded members of the teams in accordance with Annex II. The payment of costs incurred by staff deployed under this Article shall be made in accordance with the rules adopted pursuant to Article 95(6). 3. The operational staff seconded to the Agency shall have the tasks and powers of the members of the teams in accordance with Article 82. The Member State that has seconded those operational staff shall be considered to be their home Member State. During the secondment, the locations and duration of the deployments of seconded members of the teams shall be decided by the executive director in accordance with the operational needs. The Agency shall ensure the continuous training of the operational staff during their secondment. 4. By 30 June of each year, each Member State shall indicate the candidates for secondment among their operational staff in accordance with the specific numbers and profiles of staff decided by the management board for the following year as referred to in Article 54(4). The Agency shall verify whether the operational staff proposed by Member States correspond to the defined profiles of staff and possess the necessary language skills. By 15 September of each year, the Agency shall accept the proposed candidates or, in cases of non-compliance with the required profiles, insufficient language skills, misconduct or infringement of the applicable rules during previous deployments, shall refuse the candidates in question and request that the Member State propose other candidates for secondment. 5. Where, due to force majeure, an individual operational staff member cannot be seconded or is unable to continue his or her secondment, the Member State concerned shall ensure that that staff member is replaced by another operational staff member having the required profile. Article 57 Member States' participation in the standing corps through short-term deployments 1. In addition to the secondments under Article 56, by 30 June of each year, the Member States shall contribute to the standing corps by nominating border guards and other relevant staff to the preliminary national list of available operational staff for short-term deployments (category 3) in accordance with the contributions set out in Annex III and in accordance with the specific numbers and profiles of staff decided by the management board for the following year as referred to in Article 54(4). The preliminary national lists of nominated operational staff shall be communicated to the Agency. The final composition of the annual list shall be confirmed to the Agency after the conclusion of the annual bilateral negotiations by 1 December of that year. 2. Each Member State shall ensure that nominated operational staff are available at the request of the Agency in accordance with the arrangements set out in this Article. Each staff member shall be available for a period of up to four months within a calendar year. However, Member States may decide to deploy an individual staff member beyond four months. Such an extension shall be counted as a separate contribution of that Member State for the same profile or another required profile if the staff member possesses the necessary skills. The payment of the costs incurred by staff deployed under this Article shall be made in accordance with the rules adopted pursuant to Article 45(2). 3. The operational staff deployed under this Article shall have the tasks and powers of the members of the teams in accordance with Article 82. 4. The Agency may verify whether the operational staff nominated for short-term deployments by Member States correspond to the defined profiles of staff and possess the necessary language skills. The Agency shall refuse nominated operational staff in cases of insufficient language skills, misconduct or infringement of the applicable rules during previous deployments. The Agency shall also refuse nominated operational staff in the event of non-compliance with the required profiles unless the operational staff member in question qualifies for another profile allocated to that Member State. In the event of the refusal of a staff member by the Agency, the Member State concerned shall ensure that that staff member is replaced by another operational staff member having the required profile. 5. By 31 July of each year, the Agency shall request that Member States contribute specific individual operational staff members for deployment as part of joint operations for the following year within the required numbers and profiles. The periods of individual deployment shall be decided in the annual bilateral negotiations and agreements between the Agency and Member States. 6. Following the annual bilateral negotiations, Member States shall make the operational staff from the national lists referred to in paragraph 1 available for specific deployments within the numbers and profiles specified in the request of the Agency. 7. Where, due to force majeure, an individual operational staff member cannot be deployed in accordance with the agreements, the Member State concerned shall ensure that such staff member is replaced by another staff member from the list with the required profile. 8. In the event of an increased need for the reinforcement of an ongoing joint operation, a need to launch a rapid border intervention or a new joint operation not specified in the relevant annual work programme or in the corresponding result of annual bilateral negotiations, the deployment shall be carried out within the limits set out in Annex III. The executive director shall inform the Member States without delay about the additional needs by indicating possible numbers and profiles of operational staff to be provided by each Member State. Once an amended operational plan or, where relevant, a new operational plan is agreed upon by the executive director and the host Member State, the formal request for the number and profiles of operational staff shall be made by the executive director. The members of the teams shall be deployed from each Member State within 20 working days from that formal request without prejudice to Article 39. 9. Where the risk analysis or any available vulnerability assessment shows that a Member State is faced with a situation that would substantially affect the discharge of its national tasks, that Member State shall contribute operational staff in accordance with the requests referred to in paragraph 5 or 8 of this Article. However, those contributions shall not cumulatively exceed half of that Member State's contribution for the year in question as set out in Annex III. Where a Member State invokes such an exceptional situation, it shall provide comprehensive reasons and information on the situation to the Agency in writing, the content of which shall be included in the report referred to in Article 65. 10. The duration of the deployment for a specific operation shall be determined by the home Member State but in any event shall not be less than 30 days, except where the operation of which the deployment is a part has a duration shorter than 30 days. 11. The technical crew taken into account for the contributions of Member States in accordance with Article 54(5) shall only be deployed in accordance with the agreements arising from the annual bilateral negotiations for the corresponding items of technical equipment referred to Article 64(9). By way of derogation from paragraph 1 of this Article, Member States shall include in their annual lists the technical crew referred to in the first subparagraph of this paragraph only after the conclusion of the annual bilateral negotiations. Member States may adjust the relevant annual lists in the event of any changes of the technical crew during the year in question. Member States shall notify those changes to the Agency. The verification referred to in paragraph 4 of this Article shall not concern the competence to operate the technical equipment. Crew members having exclusively technical duties shall only be indicated by function on national annual lists. The duration of deployment of technical crews shall be determined in accordance with Article 64. Article 58 Member States' participation in the standing corps through the reserve for rapid reaction 1. The Member States shall contribute operational staff to the standing corps by means of a reserve for rapid reaction (category 4) to be activated for rapid border interventions in accordance with Article 37(2) and Article 39, provided that the operational staff in category 1, 2 and 3 have already been fully deployed for the rapid border intervention in question. 2. Each Member State shall be responsible for ensuring that operational staff are available in the numbers and with the corresponding profiles decided by the management board for the following year as referred to in Article 54(4), at the request of the Agency within the limits set out in Annex IV and in accordance with the arrangements set out in this Article. Each operational staff member shall be available for a period of up to four months within a calendar year. 3. The specific deployments in the framework of rapid border interventions from the reserve for rapid reaction shall take place in accordance with Article 39(11) and (13). Article 59 Review of the standing corps 1. By 31 December 2023, in particular on the basis of the reports referred to in Article 62(10) and Article 65, the Commission shall present to the European Parliament and to the Council a review of the overall number and composition of the standing corps, including the size of individual Member States' contributions to the standing corps, as well as of the expertise and professionalism of the standing corps and of the training it receives. The review shall also examine whether it is necessary to maintain the reserve for rapid reaction as part of the standing corps. The review shall describe and take into account existing and potential operational needs for the standing corps covering rapid reaction capacities, significant circumstances affecting the capability of Member States to contribute to the standing corps and the evolution of the statutory staff as regards the contribution of the Agency to the standing corps. 2. By 29 February 2024, the Commission shall, where necessary, submit appropriate proposals to amend Annexes I, II, III and IV. Where the Commission does not submit a proposal, it shall explain the reasons therefor. Article 60 Antenna offices 1. Subject to an agreement with the host Member State or the explicit inclusion of this possibility in the status agreement concluded with the host third country, the Agency may establish antenna offices on the territory of that Member State or third country in order to facilitate and improve coordination of operational activities, including in the field of return, organised by the Agency in that Member State, in the neighbouring region, or in that third country and in order to ensure the effective management of the human and technical resources of the Agency. The antenna offices shall be established in accordance with operational needs for the period of time necessary for the Agency to carry out significant operational activities in that specific Member State, in the neighbouring region, or in the third country concerned. That period of time may be prolonged, if necessary. Before an antenna office is established, all budgetary consequences shall be carefully assessed and calculated and the relevant amounts shall be budgeted in advance. 2. The Agency and the host Member State or host third country in which the antenna office is established shall make the necessary arrangements to provide the best possible conditions needed to fulfil the tasks assigned to the antenna office. The place of employment for the staff working in antenna offices shall be set in accordance with Article 95(2). 3. The antenna offices shall, where applicable: (a) provide operational and logistical support and ensure the coordination of Agency's activities in the operational areas concerned; (b) provide operational support to the Member State or the third country in the operational areas concerned; (c) monitor the activities of the teams and regularly report to the Agency's headquarters; (d) cooperate with the host Member State or host third country on all issues related to the practical implementation of the operational activities organised by the Agency in that Member State or third country, including any additional issues that might have occurred in the course of these activities; (e) support the coordinating officer referred to in Article 44 in his or her cooperation with the participating Member States on all issues related to their contribution to the operational activities organised by the Agency and, where necessary, liaise with the Agency's headquarters; (f) support the coordinating officer and fundamental rights monitors assigned to monitor an operational activity in facilitating, where necessary, the coordination and communication between the Agency's teams and the relevant authorities of the host Member State or host third country as well any relevant tasks; (g) organise logistical support relating to the deployment of the members of the teams and the deployment and use of technical equipment; (h) provide all other logistical support regarding the operational area for which a given antenna office is responsible, with a view to facilitating the smooth running of the operational activities organised by the Agency; (i) support the Agency's liaison officer, without prejudice to his or her tasks and functions referred to in Article 31, in identifying any current or future challenges for the border management of the area for which a given antenna office is responsible, for the implementation of the return acquis and regularly report to the Agency's headquarters; (j) ensure the effective management of the Agency's own equipment in the areas covered by its activities, including the possible registration and long-term maintenance of that equipment and any logistical support needed. 4. Each antenna office shall be managed by a representative of the Agency appointed by the executive director as a head of an antenna office. The head of the antenna office shall oversee the overall work of the office and shall act as its single point of contact with the Agency's headquarters. 5. On the basis of a proposal from the executive director, the management board shall decide on the establishing, composition, duration and, where needed, possible prolongation of the duration of the operation of an antenna office taking into account the opinion of the Commission and the agreement of the host Member State or the host third country. 6. The host Member State shall provide the Agency with assistance to ensure operational capacity. 7. The executive director shall report to the management board on a quarterly basis on the activities of antenna offices. The activities of the antenna offices shall be described in a separate section of the annual activity report. Article 61 Financial support for the development of the standing corps 1. Member States shall be entitled to receive funding on a yearly basis in the form of financing not linked to costs, in order to support the development of human resources to secure their contributions to the standing corps as set out in Annexes II, III and IV, in accordance with point (a) of Article 125(1) of Regulation (EU, Euratom) 2018/1046. That financing shall be payable after the end of the year concerned and upon fulfilment of conditions laid down in paragraphs 3 and 4 of this Article. That financing shall be based on a reference amount as set in paragraph 2 of this Article and shall amount to, where applicable: (a) 100 % of the reference amount multiplied by the number of operational staff indicated for the year N + 2 for secondment in accordance with Annex II; (b) 37 % of the reference amount multiplied by the number of operational staff effectively deployed in accordance with Article 57 within the limit set in Annex III and in accordance with Article 58 within the limit set in Annex IV, as applicable; (c) a one-off payment of 50 % of the reference amount multiplied by the number of operational staff recruited by the Agency as statutory staff; that payment shall apply to staff departing from national services, being in active service no longer than 15 years at the time of recruitment by the Agency. 2. The reference amount shall be equivalent to the annual basic salary for a contract agent in function group III, grade 8, step 1 as set out in Article 93 of the Conditions of Employment and subject to a correction co-efficient applicable in the Member State concerned. 3. The annual payment of the amount referred to in point (a) of paragraph 1 of this Article shall only become due provided that the Member States increase their respective overall national border guard staffing accordingly through the recruitment of new staff in the period concerned. The relevant information for the purpose of reporting shall be provided to the Agency in the annual bilateral negotiations and shall be verified through the vulnerability assessment in the following year. The annual payment of the amount referred to in point (b) of paragraph 1 of this Article shall be due in full in relation to the number of staff effectively deployed for a consecutive or non-consecutive period of four months in accordance with Article 57 within the limit set in Annex III and in accordance with Article 58 within the limit set in Annex IV. For effective deployments referred to in point (b) of paragraph 1 of this Article, the payments shall be calculated on a pro rata basis with a reference period of four months. The Agency shall grant an advance payment linked to the annual payments of the amounts referred to in points (a) and (b) of paragraph 1 of this Article in accordance with the implementing act referred to in paragraph 4 of this Article following the submission of a specific and justified request by the contributing Member State. 4. The Commission shall adopt an implementing act laying down detailed rules for the annual payment and the monitoring of the applicable conditions provided in paragraph 3 of this Article. Those rules shall include arrangements for advanced payments upon fulfilment of the conditions set out in paragraph 3 of this Article, as well as the arrangements for pro-rata calculations, including with respect to cases where the deployment of technical crew would exceptionally exceed the maximum national contributions set out in Annex III. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 122(2). 5. When implementing the financial support under this Article, the Agency and the Member States shall ensure compliance with the principles of co-financing and no double funding. Article 62 Training 1. The Agency shall, taking into account the capability roadmap referred to in Article 9(8), where available, and in cooperation with the appropriate training entities of the Member States, and, where appropriate, EASO, FRA, the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) and the European Union Agency for Law Enforcement Training (CEPOL), develop specific training tools, including specific training in the protection of children and other persons in a vulnerable situation. Training content shall take into account relevant research outcomes and best practices. The Agency shall provide border guards, return specialists, return escorts and other relevant staff who are members of the standing corps as well as forced-return monitors and fundamental rights monitors with specialised training relevant to their tasks and powers. The Agency shall conduct regular exercises with those border guards and other members of the teams in accordance with the specialised training schedule referred to in the annual work programme of the Agency. 2. The Agency shall ensure that, in addition to the training referred to in Article 55(3), all statutory staff to be deployed as members of the teams have received adequate training in relevant Union and international law, including on fundamental rights, access to international protection, guidelines for the purpose of identifying persons seeking protection and directing them towards the appropriate procedures, guidelines for addressing the special needs of children, including unaccompanied minors, victims of trafficking in human beings, persons in need of urgent medical assistance and other particularly vulnerable persons, and, where it is intended that they participate in sea operations, search and rescue, prior to their initial deployment in operational activities organised by the Agency. Such training shall also cover the use of force in accordance with Annex V. 3. For the purpose of paragraph 2, the Agency, on the basis of agreements with selected Member States, shall implement the necessary training programmes in those Member States' specialised institutions for training and education, including the Agency's partnership academies in Member States. The Agency shall ensure that the training follows the common core curricula, is harmonised and fosters mutual understanding and a common culture based on the values enshrined in the Treaties. The Agency shall cover the full cost of training. The Agency, after obtaining the approval of the management board, may set up an Agency training centre to further facilitate the inclusion of a common European culture in the training provided. 4. The Agency shall take the necessary initiatives to ensure that all staff of the Member States who participate in the teams from the standing corps have received the training referred to in the first subparagraph of paragraph 2. 5. The Agency shall take the necessary initiatives to ensure training for staff involved in return-related tasks who are allocated to the standing corps or to the pool referred to in Article 51. The Agency shall ensure that statutory staff and all staff who participate in return operations or return interventions have received training in relevant Union and international law, including on fundamental rights, access to international protection and on referral of vulnerable persons, prior to their participation in operational activities organised by the Agency. 6. The Agency shall establish and further develop common core curricula for the training of border guards and provide training at European level for instructors of the border guards of Member States, including with regard to fundamental rights, access to international protection and relevant maritime law, as well as a common curriculum for the training of staff involved in return-related tasks. The common core curricula shall aim to promote the highest standards and best practices in the implementation of Union border management and return law. The Agency shall draw up the common core curricula after consulting the consultative forum referred to in Article 108 (the \u2018consultative forum\u2019) and the fundamental rights officer. Member States shall integrate the common core curricula into the training they provide to their national border guards and staff involved in return-related tasks. 7. The Agency shall also offer additional training courses and seminars on subjects related to external border control and return of third-country nationals for officers of the competent services of Member States and, where appropriate, of third countries. 8. The Agency may organise training activities in cooperation with Member States and third countries on their territory. 9. The Agency shall establish an exchange programme enabling border guards participating in its teams and staff participating in the return intervention teams to acquire knowledge or specific know-how from experience and good practices abroad by working with border guards and staff involved in return-related tasks in a Member State other than their own. 10. The Agency shall establish and further develop an internal quality control mechanism to ensure a high level of training, expertise and professionalism of statutory staff, in particular statutory staff who participate in the operational activities of the Agency. On the basis of the implementation of the quality control mechanism, the Agency shall prepare an annual evaluation report which shall be annexed to the annual activity report. Article 63 Acquisition or leasing of technical equipment 1. The Agency may acquire, either on its own or as co-owner with a Member State, or lease technical equipment to be deployed during joint operations, pilot projects, rapid border interventions, activities in the area of return, including return operations and return interventions, migration management support team deployments or technical assistance projects in accordance with the financial rules applicable to the Agency. 2. On the basis of a proposal from the executive director, the management board shall adopt a comprehensive multiannual strategy on how the Agency's own technical capabilities are to be developed taking into account the multiannual strategic policy cycle for European integrated border management, including the capability roadmap referred to in Article 9(8), where available, and the budgetary resources made available for that purpose in the multiannual financial framework. To ensure compliance with the applicable legal, financial and policy frameworks, the executive director shall only make the proposal after receiving the positive opinion of the Commission. The multiannual strategy shall be accompanied by a detailed implementation plan specifying the timeline for acquisition or leasing, procurement planning and risk mitigation. If the management board, when adopting the strategy and the plan, decides to depart from the opinion of the Commission, it shall provide the Commission with a justification for doing so. Following the adoption of the multiannual strategy, the implementation plan shall become part of the multiannual programming component of the single programing document referred to in point (k) of Article 100(2). 3. The Agency may acquire technical equipment by decision of the executive director in consultation with the management board in accordance with the applicable procurement rules. Any acquisition or leasing of equipment entailing significant costs to the Agency shall be preceded by a thorough needs and cost-benefit analysis. Any expenditure related to such acquisition or leasing shall be provided for in the Agency's budget adopted by the management board. 4. Where the Agency acquires or leases major technical equipment such as aircraft, service vehicles or vessels, the following conditions shall apply: (a) in the case of an acquisition by the Agency or co-ownership, the Agency shall agree with one Member State that that Member State is to provide that the equipment be registered as being on government service in accordance with the applicable law of that Member State, including prerogatives and immunities for such technical equipment under international law; (b) in the case of leasing, the equipment shall be registered in a Member State. 5. On the basis of a model agreement drawn up by the Agency and approved by the management board, the Member State of registration and the Agency shall agree on terms ensuring the operability of the equipment. In the case of co-owned assets, the terms shall also cover the periods of full availability of the assets for the Agency and determine the use of those assets, including specific provisions on rapid deployment during rapid border interventions and the financing of those assets. 6. Where the Agency does not have the required qualified statutory staff, the Member State of registration or the supplier of technical equipment shall provide the necessary experts and technical crew to operate the technical equipment in a legally sound and safe manner in accordance with the model agreement referred to in paragraph 5 of this Article and planned on the basis of the annual bilateral negotiations and agreements referred to in Article 64(9). In such a case, technical equipment owned solely by the Agency shall be made available to the Agency upon its request and the Member State of registration may not invoke the exceptional situation referred to in Article 64(9). When requesting a Member State to provide technical equipment and staff, the Agency shall take into account the particular operational challenges facing that Member State at the time of the request. Article 64 Technical equipment pool 1. The Agency shall set up and keep centralised records of equipment in a technical equipment pool composed of equipment owned either by the Member States or by the Agency and equipment co-owned by the Member States and by the Agency for its operational activities. 2. Equipment solely owned by the Agency shall be fully available for deployment at any time. 3. Equipment co-owned by the Agency at a share of more than 50 % shall also be available for deployment in accordance with an agreement between a Member State and the Agency, concluded in accordance with Article 63(5). 4. The Agency shall ensure the compatibility and interoperability of the equipment listed in the technical equipment pool. 5. For the purposes of paragraph 4, the Agency, in close cooperation with the Member States and the Commission, shall define technical standards for the equipment to be deployed in the activities of the Agency, where necessary. Equipment that is acquired by the Agency, whether as sole or co-owner, and equipment owned by Member States which is listed in the technical equipment pool shall meet those standards. 6. On the basis of a proposal from the executive director taking into account the Agency's risk analysis and the results of vulnerability assessments, the management board shall decide, by 31 March of each year, on the minimum number of items of technical equipment required to meet the needs of the Agency in the following year, in particular as regards carrying out joint operations, migration management support team deployments, rapid border interventions, activities in the area of return, including return operations and return interventions. The Agency's own equipment shall be included in the minimum number of items of technical equipment. That decision shall establish rules relating to the deployment of technical equipment in the operational activities. If the minimum number of items of technical equipment proves to be insufficient to carry out the operational plan agreed for such activities, the Agency shall revise that minimum number on the basis of justified needs and of an agreement with the Member States. 7. The technical equipment pool shall contain the minimum number of items of equipment identified as needed by the Agency per type of technical equipment. The equipment listed in the technical equipment pool shall be deployed during joint operations, migration management support team deployments, pilot projects, rapid border interventions, return operations or return interventions. 8. The technical equipment pool shall include a rapid reaction equipment pool containing a limited number of items of equipment needed for possible rapid border interventions. The contributions of Member States to the rapid reaction equipment pool shall be planned in accordance with the annual bilateral negotiations and agreements referred in paragraph 9 of this Article. For the equipment on the list of the items in that pool, Member States may not invoke the exceptional situation referred to in paragraph 9 of this Article. The Member State concerned shall send the equipment on that list, together with the necessary experts and technical crew, to the destination for deployment as soon as possible, and, in any event, no later than 10 days after the date on which the operational plan is agreed. The Agency shall contribute to this pool with equipment at the Agency's disposal as referred to in Article 63(1). 9. Member States shall contribute to the technical equipment pool. The contribution by Member States to the pool and deployment of the technical equipment for specific operations shall be planned on the basis of annual bilateral negotiations and agreements between the Agency and Member States. In accordance with those agreements and to the extent that it forms part of the minimum number of items of technical equipment for a given year, Member States shall make their technical equipment available for deployment at the request of the Agency, unless they are faced with an exceptional situation substantially affecting the discharge of national tasks. If a Member State invokes such an exceptional situation, it shall provide, in writing, comprehensive reasons and information on the situation to the Agency, the content of which shall be included in the report referred to in Article 65(1). The Agency's request shall be made at least 45 days before the intended deployment of major technical equipment and 30 days before the intended deployment of other equipment. The contributions to the technical equipment pool shall be reviewed annually. 10. On the basis of a proposal from the executive director, the management board shall decide, on a yearly basis, on the rules relating to technical equipment, including the required overall minimum numbers of items per type of technical equipment and the terms for the deployment and reimbursement of costs as well as on the limited number of items of technical equipment for a rapid reaction equipment pool. For budgetary purposes that decision shall be taken by the management board by 31 March of each year. 11. Where a rapid border intervention takes place, Article 39(15) shall apply accordingly. 12. Where unexpected needs for technical equipment for a joint operation or a rapid border intervention arise after the minimum number of items of technical equipment has been set and those needs cannot be met from the technical equipment pool or the rapid reaction equipment pool, Member States shall, where possible, on an ad hoc basis, make the necessary technical equipment available for deployment to the Agency upon its request. 13. The executive director shall regularly report to the management board on the composition and the deployment of equipment which is part of the technical equipment pool. Where the minimum number of items of technical equipment required in the pool has not been met, the executive director shall inform the management board without delay. The management board shall take a decision on the prioritisation of the deployment of the technical equipment urgently and take the appropriate steps to remedy the shortfall. The management board shall inform the Commission of the shortfall and the steps it has taken. The Commission shall subsequently inform the European Parliament and the Council thereof and of its own assessment. 14. Member States shall register in the technical equipment pool all the means of transport and operating equipment purchased under the specific actions of the Internal Security Fund in accordance with Article 7(1) of Regulation (EU) No 515/2014 of the European Parliament and of the Council (42) or, where relevant, any other future dedicated Union funding made available to the Member States with the clear objective of increasing the operational capacity of the Agency. That technical equipment shall form part of the minimum number of items of technical equipment for a given year. Upon a request made by the Agency in the framework of the annual bilateral negotiations, the Member States shall make technical equipment co-financed under the specific actions of the Internal Security Fund or by any other future dedicated Union funding as specified in the first subparagraph of this paragraph available for deployment to the Agency. Each item of equipment shall be made available for a period of up to four months as planned in the annual bilateral negotiations. Member States may decide to deploy an item of equipment beyond four months. In the case of an operational activity referred to in Article 39 or 42 of this Regulation, Member States may not invoke the exceptional situation referred to in paragraph 9 of this Article. 15. The Agency shall manage the records of the technical equipment pool as follows: (a) classification by type of equipment and by type of operation; (b) classification by owner (Member State, Agency, other); (c) overall numbers of items of equipment required; (d) crew requirements if applicable; (e) other information, such as registration details, transportation and maintenance requirements, national applicable export regimes, technical instructions, or other information relevant to appropriate use of the equipment; (f) indication as to whether an item of equipment was financed from Union funding. 16. The Agency shall finance 100 % of the deployment of technical equipment which forms part of the minimum number of items of technical equipment provided by a given Member State for a given year. The deployment of technical equipment which does not form part of the minimum number of items of technical equipment shall be co-financed by the Agency, up to a maximum of 100 % of the eligible expenses, taking into account the particular circumstances of the Member States deploying such technical equipment. Article 65 Reporting on the Agency's capabilities 1. On the basis of a proposal from the executive director, the management board shall adopt and submit to the European Parliament, to the Council and to the Commission an annual report on the implementation of Articles 51, 55, 56, 57, 58, 63 and 64 (\u2018annual implementation report\u2019). 2. The annual implementation report shall include, in particular: (a) the number of staff that each Member State has committed to the standing corps, including through the reserve for rapid reaction, and to the pool of forced-return monitors; (b) the number of statutory staff that the Agency has committed to the standing corps; (c) the number of staff actually deployed from the standing corps, by each Member State and by the Agency per profile in the previous year; (d) the number of items of technical equipment that each Member State and the Agency has committed to the technical equipment pool; (e) the number of items of technical equipment deployed by each Member State and the Agency in the previous year from the technical equipment pool; (f) commitments to and deployments of equipment from the rapid reaction equipment pool; (g) the development of the Agency's own human and technical capabilities. 3. The annual implementation report shall list the Member States that invoked the exceptional situation referred to in Article 57(9) and Article 64(9) in the previous year and include the reasons and information provided by the Member State concerned. 4. To ensure transparency, the executive director shall inform the management board on a quarterly basis on the elements listed in paragraph 2 in relation to the ongoing year. Article 66 Research and innovation 1. The Agency shall proactively monitor and contribute to research and innovation activities relevant for European integrated border management including the use of advanced border control technology, taking into account the capability roadmap referred to in Article 9(8). The Agency shall disseminate the results of that research to the European Parliament, to the Member States and to the Commission in accordance with Article 92. It may use those results as appropriate in joint operations, rapid border interventions, return operations and return interventions. 2. The Agency, taking into account the capability roadmap referred to in Article 9(8), shall assist the Member States and the Commission in identifying key research themes. The Agency shall assist Member States and the Commission in drawing up and implementing the relevant Union framework programmes for research and innovation activities. 3. The Agency shall implement the parts of the Framework Programme for Research and Innovation which relate to border security. For that purpose, and where the Commission has delegated the relevant powers to it, the Agency shall have the following tasks: (a) managing some stages of programme implementation and some phases in the lifetime of specific projects on the basis of the relevant work programmes adopted by the Commission; (b) adopting the instruments of budget execution for revenue and expenditure and carrying out all the operations necessary for the management of the programme; (c) providing support in programme implementation. 4. The Agency may plan and implement pilot projects regarding matters covered by this Regulation. 5. The Agency shall make public information on its research projects, including demonstration projects, the cooperation partners involved and the project budget. SECTION 10 The European Travel Information and Authorisation System (ETIAS) Article 67 ETIAS Central Unit The Agency shall ensure the setting-up and operation of an ETIAS Central Unit as referred to in Article 7 of Regulation (EU) 2018/1240. SECTION 11 Cooperation Article 68 Cooperation of the Agency with Union institutions, bodies, offices, agencies, and international organisations 1. The Agency shall cooperate with Union institutions, bodies, offices and agencies, and may cooperate with international organisations, within their respective legal frameworks, and shall make use of existing information, resources and systems available in the framework of EUROSUR. In accordance with the first subparagraph, the Agency shall cooperate, in particular, with: (a) the Commission and the European External Action Service (EEAS); (b) Europol; (c) EASO; (d) FRA; (e) Eurojust; (f) the European Union Satellite Centre; (g) EFCA and EMSA; (h) eu-LISA; (i) the European Union Aviation Safety Agency (EASA) and the Network Manager of the European Air Traffic Management Network (EATMN); (j) CSDP missions and operations, in accordance with their mandates, with a view to ensuring the following: (i) the promotion of European integrated border management standards; (ii) situational awareness and risk analysis. The Agency may also cooperate with the following international organisations, as relevant to its tasks, within their respective legal frameworks: (a) the United Nations through its relevant offices, agencies, organisations and other entities, in particular the Office of the United Nations High Commissioner for Refugees, the Office of the High Commissioner for Human Rights, the International Organization for Migration, the United Nations Office on Drugs and Crime and the International Civil Aviation Organization; (b) the International Criminal Police Organization (Interpol); (c) the Organisation for Security and Cooperation in Europe; (d) the Council of Europe and the Commissioner for Human Rights of the Council of Europe; (e) the Maritime Analysis and Operations Centre \u2014 Narcotics (MAOC-N). 2. The cooperation referred to in paragraph 1 shall take place within the framework of working arrangements concluded with the entities referred to in paragraph 1. Such arrangements shall be subject to the Commission's prior approval. The Agency shall inform the European Parliament and the Council of any such arrangements. 3. As regards the handling of classified information, the working arrangements referred to in paragraph 2 shall provide that the Union body, office or agency or international organisation concerned comply with security rules and standards equivalent to those applied by the Agency. An assessment visit shall be conducted prior to the conclusion of an arrangement and the Commission shall be informed of the outcome of the assessment visit. 4. Although outside the scope of this Regulation, the Agency shall also engage in cooperation with the Commission and, where relevant, with Member States and the EEAS in activities relating to the customs area, including risk management, where those activities support each other. That cooperation shall be without prejudice to the existing competence of the Commission, of the High Representative of the Union for Foreign Affairs and Security Policy and of the Member States. 5. Union institutions, bodies, offices, agencies, and the international organisations referred to in paragraph 1, shall use information received from the Agency only within the limits of their competence and insofar as they respect fundamental rights, including data protection requirements. Any transmission of personal data processed by the Agency to other Union institutions, bodies, offices and agencies under points (c) and (d) of Article 87(1) shall be subject to specific working arrangements regarding the exchange of personal data. The working arrangements referred to in the second subparagraph shall include a provision ensuring that personal data transmitted to Union institutions, bodies, offices and agencies by the Agency may be processed for another purpose only if authorised by the Agency and if compatible with the initial purpose for which the data were collected and transmitted by the Agency. Those Union institutions, bodies, offices and agencies shall keep written records of a case-by-case compatibility assessment. Any transfer of personal data by the Agency to international organisations under point (c) of Article 87(1) shall be in accordance with the data protection provisions laid down in Section 2 of Chapter IV. In particular, the Agency shall ensure that any working arrangement concluded with international organisations regarding the exchange of personal data under point (c) of Article 87(1) complies with Chapter V of Regulation (EU) 2018/1725 and is subject to the authorisation of the European Data Protection Supervisor, where provided for by that Regulation. The Agency shall ensure that personal data transferred to international organisations are only processed for the purposes for which they were transferred. 6. The exchange of information between the Agency and Union institutions, bodies, offices and agencies, and international organisations referred to in paragraph 1, shall be conducted via the communication network referred to in Article 14 or via other accredited information exchange systems which fulfil the criteria of availability, confidentiality and integrity. Article 69 European cooperation on coast guard functions 1. Without prejudice to EUROSUR, the Agency shall, in cooperation with EFCA and EMSA, support national authorities carrying out coast guard functions at national and Union level and, where appropriate, at international level by: (a) sharing, fusing and analysing information available in ship reporting systems and other information systems hosted by or accessible to those agencies, in accordance with their respective legal bases and without prejudice to the ownership of data by Member States; (b) providing surveillance and communication services based on state-of-the-art technology, including space-based and ground infrastructure and sensors mounted on any kind of platform; (c) building capacity by drawing up guidelines and recommendations and by establishing best practices as well as by providing training and exchange of staff; (d) enhancing the exchange of information and cooperation on coast guard functions, including by analysing operational challenges and emerging risks in the maritime domain; (e) sharing capacity by planning and implementing multipurpose operations and by sharing assets and other capabilities, to the extent that those activities are coordinated by those agencies and are agreed to by the competent authorities of the Member States concerned. 2. The precise forms of cooperation on coast guard functions between the Agency, EFCA and EMSA shall be determined in a working arrangement in accordance with their respective mandates and with the financial rules applicable to those agencies. Such an arrangement shall be approved by the management board of the Agency and the administrative boards of EFCA and EMSA. The Agency, EFCA and EMSA shall use information received in the context of their cooperation only within the limits of their legal framework and in compliance with fundamental rights, including data protection requirements. 3. The Commission shall, in close cooperation with the Member States, the Agency, EFCA and EMSA, make available a practical handbook on European cooperation on coast guard functions. That handbook shall contain guidelines, recommendations and best practices for the exchange of information. The Commission shall adopt the handbook in the form of a recommendation. Article 70 Cooperation with Ireland and the United Kingdom 1. The Agency shall facilitate operational cooperation of the Member States with Ireland and the United Kingdom in specific activities. 2. For the purposes of EUROSUR, the exchange of information and cooperation with Ireland and the United Kingdom may take place on the basis of bilateral or multilateral agreements between Ireland or the United Kingdom respectively and one or several neighbouring Member States or through regional networks based on those agreements. The national coordination centres shall be the contact points for the exchange of information with the corresponding authorities of Ireland and the United Kingdom within EUROSUR. 3. The agreements referred to in paragraph 2 shall be limited to the following exchanges of information between a national coordination centre and the corresponding authority of Ireland or the United Kingdom: (a) information contained in the national situational picture of the Member State, to the extent such information was transmitted to the Agency for the purposes of the European situational picture; (b) information collected by Ireland or the United Kingdom which is relevant for the purposes of the European situational picture; (c) information as referred to in Article 25(5). 4. Information provided in the context of EUROSUR by the Agency or by a Member State which is not party to an agreement as referred to in paragraph 2 shall not be shared with Ireland or the United Kingdom without the prior approval of the Agency or that Member State. The Member States and the Agency shall be bound by the refusal to share that information with Ireland or the United Kingdom. 5. The onward transmission or other communication of information exchanged under this Article to third countries or to third parties shall be prohibited. 6. The agreements referred to in paragraph 2 shall include provisions on the financial costs arising from the participation of Ireland or the United Kingdom in the implementation of those agreements. 7. Support to be provided by the Agency pursuant to points (n), (o) and (p) of Article 10(1) shall cover the organisation of return operations of Member States in which Ireland or the United Kingdom also participates. 8. The application of this Regulation to the borders of Gibraltar shall be suspended until the date on which an agreement is reached on the scope of the measures concerning the crossing by persons of the external borders. Article 71 Cooperation with third countries 1. The Member States and the Agency shall cooperate with third countries for the purpose of European integrated border management and migration policy in accordance with point (g) of Article 3(1). 2. On the basis of the policy priorities set out in accordance with Article 8(4), the Agency shall provide technical and operational assistance to third countries within the framework of the external action policy of the Union, including with regard to the protection of fundamental rights and personal data and with regard to the principle of non-refoulement. 3. The Agency and Member States shall comply with Union law, including norms and standards which form part of the Union acquis, including where cooperation with third countries takes place on the territory of those third countries. 4. The establishment of cooperation with third countries shall serve to promote European integrated border management standards. Article 72 Cooperation of Member States with third countries 1. Member States may cooperate at an operational level with one or more third countries in relation to the areas covered by this Regulation. Such cooperation may include the exchange of information and may take place on the basis of bilateral or multilateral agreements, other forms of arrangements, or through regional networks established on the basis of those agreements. 2. When concluding the bilateral and multilateral agreements referred to in paragraph 1 of this Article, Member States may include provisions concerning the exchange of information and cooperation for the purposes of EUROSUR in accordance with Articles 75 and 89. 3. The bilateral and multilateral agreements and other forms of arrangements referred to in paragraph 1 shall comply with Union and international law on fundamental rights and on international protection, including the Charter, the European Convention for the Protection of Human Rights and Fundamental Freedoms and the 1951 Convention relating to the Status of Refugees, the 1967 Protocol thereto, and in particular the principle of non-refoulement. When implementing such agreements and arrangements, Member States shall assess and take into account the general situation in the third country on a regular basis, and shall have regard to Article 8. Article 73 Cooperation between the Agency and third countries 1. The Agency may cooperate, to the extent required for the fulfilment of its tasks, with the authorities of third countries competent in matters covered by this Regulation. The Agency shall comply with Union law, including norms and standards which form part of the Union acquis, including where cooperation with third countries takes place on the territory of those third countries. 2. When cooperating with the authorities of third countries, as referred to in paragraph 1 of this Article, the Agency shall act within the framework of the external action policy of the Union, including with regard to the protection of fundamental rights and personal data, the principle of non-refoulement, the prohibition of arbitrary detention and the prohibition of torture and inhuman or degrading treatment or punishment, with the support of, and in coordination with, Union delegations and, where relevant, CSDP missions and operations in accordance with point (j) of the second subparagraph of Article 68(1). 3. In circumstances requiring the deployment of border management teams from the standing corps to a third country where the members of the teams will exercise executive powers, a status agreement drawn up on the basis of the model status agreement referred to in Article 76(1) shall be concluded by the Union with the third country concerned on the basis of Article 218 of the Treaty on the Functioning of the European Union (TFEU). The status agreement shall cover all aspects that are necessary for carrying out the actions. It shall set out, in particular, the scope of the operation, provisions on civil and criminal liability, the tasks and powers of the members of the teams, measures related to the establishment of an antenna office and practical measures related to the respect of fundamental rights. The status agreement shall ensure that fundamental rights are fully respected during those operations and shall provide for a complaints mechanism. The European Data Protection Supervisor shall be consulted on the provisions of the status agreement related to the transfer of data if those provisions differ substantially from the model status agreement. 4. Where available, the Agency shall also act within the framework of working arrangements concluded with the authorities of third countries referred to in paragraph 1 of this Article in accordance with Union law and policy, in accordance with Article 76(4). The working arrangements referred to in the first subparagraph of this paragraph shall specify the scope, nature and purpose of the cooperation and shall be related to the management of operational cooperation. Such working arrangements may include provisions concerning the exchange of sensitive non-classified information and cooperation in the framework of EUROSUR in accordance with Article 74(3). The Agency shall ensure that the third countries to which information is transferred only process that information for the purposes for which it was transferred. Any working arrangements on exchanging classified information shall be concluded in accordance with Article 76(4) of this Regulation. The Agency shall request prior authorisation from the European Data Protection Supervisor where those working arrangements provide for the transfer of personal data and where provided for by Regulation (EU) 2018/1725. 5. The Agency shall contribute to the implementation of the Union external policy on return and readmission within the framework of the external action policy of the Union and regarding matters covered by this Regulation. 6. The Agency may receive Union funding in accordance with the provisions of the relevant instruments supporting third countries and activities relating to them. It may launch and finance technical assistance projects in third countries regarding matters covered by this Regulation and in accordance with the financial rules applicable to the Agency. Such projects shall be included in the single programming document referred to in Article 102. 7. The Agency shall inform the European Parliament, the Council and the Commission of activities conducted pursuant to this Article and, in particular, of the activities related to technical and operational assistance in the field of border management and return in third countries, and the deployment of liaison officers, and shall provide them with detailed information on compliance with fundamental rights. The Agency shall make public the agreements, working arrangements, pilot projects and technical assistance projects with third countries in accordance with Article 114(2). 8. The Agency shall include an assessment of the cooperation with third countries in its annual reports. Article 74 Technical and operational assistance provided by the Agency to third countries 1. The Agency may coordinate operational cooperation between Member States and third countries and provide technical and operational assistance to third countries in the context of European integrated border management. 2. The Agency may carry out actions related to European integrated border management on the territory of a third country subject to the agreement of that third country. 3. Operations on the territory of a third country shall be included in the annual work programme adopted by the management board in accordance with Article 102, and shall be carried out on the basis of an operational plan agreed between the Agency and the third country concerned and in consultation with the participating Member States. Where a Member State or Member States neighbour the third country or border the operational area of the third country, the operational plan and any amendments thereto shall be subject to the agreement of that Member State or those Member States. Articles 38, 43, 46, 47 and 54 to 57 shall apply mutatis mutandis to deployments in third countries. 4. The executive director shall ensure the security of the staff deployed in third countries. For the purpose of the first subparagraph, Member States shall inform the executive director of any concern related to the security of their nationals should they be deployed on the territory of certain third countries. Where the security of any staff member deployed in third countries cannot be guaranteed, the executive director shall take appropriate measures by suspending or terminating the corresponding aspects of the technical and operational assistance provided by the Agency to that third country. 5. Without prejudice to the deployment of the members of the standing corps in accordance with Articles 54 to 58, the participation of Member States in operations on the territory of third countries shall be voluntary. In addition to the relevant mechanism referred to in Article 57(9) and paragraph 4 of this Article, where the security of its participating staff cannot be guaranteed to the satisfaction of the Member State, that Member State may opt out of its respective contribution to the operation in the third country in question. Where a Member State invokes such an exceptional situation, it shall provide comprehensive reasons and information on the situation to the Agency in writing, the content of which shall be included in the report referred to in Article 65. Such reasons and information shall be provided during the annual bilateral negotiations or no later than 21 days prior to the deployment. The deployment of staff seconded in accordance with Article 56 shall be subject to the consent of the home Member Sate communicated upon notification by the Agency and no later than 21 days prior to the deployment. 6. Operational plans as referred to in paragraph 3 may include provisions concerning the exchange of information and cooperation for the purpose of EUROSUR in accordance with Articles 75 and 89. Article 75 Exchange of information with third countries in the framework of EUROSUR 1. The national coordination centres and, where relevant, the Agency shall be the contact points for the exchange of information and cooperation with third countries for the purposes of EUROSUR. 2. The provisions concerning exchange of information and cooperation for the purposes of EUROSUR contained in the bilateral or multilateral agreements referred to in Article 72(2) shall address: (a) the specific situational pictures shared with third countries; (b) the data originating from third countries which can be shared in the European situational picture and the procedures for sharing those data; (c) the procedures and conditions by which EUROSUR fusion services can be provided to third countries' authorities; (d) the detailed rules regarding cooperation and the exchange of information with third-country observers for the purpose of EUROSUR. 3. Information provided in the context of EUROSUR by the Agency or by a Member State which is not party to an agreement as referred to in Article 72(1) shall not be shared with a third country under that agreement without the prior approval of the Agency or of that Member State. The Member States and the Agency shall be bound by the refusal to share that information with the third country concerned. Article 76 Role of the Commission with regard to cooperation with third countries 1. The Commission, after consulting the Member States, the Agency, FRA and the European Data Protection Supervisor, shall draw up a model status agreement for actions conducted on the territory of third countries. 2. The Commission, in cooperation with the Member States and the Agency, shall draw up model provisions for the exchange of information in the framework of EUROSUR in accordance with Articles 70(2) and 72(2). The Commission, after consulting the Agency and other relevant Union bodies, offices or agencies, including FRA and the European Data Protection Supervisor, shall draw up a model for the working arrangements referred to in Article 73(4). That model shall include provisions related to fundamental rights and data protection safeguards addressing practical measures. 3. Before a new bilateral or multilateral agreement as referred to in Article 72(1) is concluded, the Member States concerned shall notify the Commission of the draft provisions related to border management and return. The Member States concerned shall notify the provisions of such existing and new bilateral and multilateral agreements related to border management and return to the Commission, which shall inform the Council and the Agency thereof. 4. Before the management board approves any working arrangements between the Agency and competent authorities of third countries, the Agency shall notify them to the Commission, which shall give its prior approval. Before any such working arrangement is concluded, the Agency shall provide the European Parliament with detailed information as regards the parties to the working arrangement and its envisaged content. 5. The Agency shall notify the operational plans referred to in Article 74(3) to the Commission. Any decision to deploy liaison officers to third countries in accordance with Article 77 shall be subject to receiving the prior opinion of the Commission. The European Parliament shall be kept fully informed of those activities without delay. Article 77 Liaison officers in third countries 1. The Agency may deploy experts from its statutory staff and other experts as liaison officers, who should enjoy the highest possible protection when carrying out their duties in third countries. They shall form part of the local or regional cooperation networks of immigration liaison officers and security experts of the Union and of the Member States, including the network set up pursuant to Regulation (EU) 2019/1240. By decision of the management board, the Agency may lay down the specific profiles of liaison officers, depending on the operational needs with regard to the third country concerned. 2. Within the framework of the external action policy of the Union, priority for the deployment of liaison officers shall be given to those third countries which, on the basis of a risk analysis, constitute a country of origin or transit regarding illegal immigration. The Agency may receive liaison officers posted by those third countries on a reciprocal basis. The management board shall, on the basis of a proposal from the executive director, adopt the list of priorities on a yearly basis. The deployment of liaison officers shall be approved by the management board following the opinion of the Commission. 3. The tasks of the Agency's liaison officers shall include establishing and maintaining contacts with the competent authorities of the third country to which they are assigned with a view to contributing to the prevention of and fight against illegal immigration and the return of returnees, including by providing technical assistance in the identification of third-country nationals and the acquisition of travel documents. Such tasks shall be carried out in compliance with Union law and shall respect fundamental rights. The Agency's liaison officers shall coordinate closely with Union delegations, with Member States in accordance with Regulation (EU) 2019/1240 and, where relevant, with CSDP missions and operations as set out in point (j) of the second subparagraph of Article 68(1). Wherever possible, they shall have their offices in the same premises as the Union delegations. 4. In third countries where return liaison officers are not deployed by the Agency, the Agency may support a Member State in deploying a return liaison officer to provide support to the Member States, as well as to support the Agency's activities, in accordance with Article 48. Article 78 Observers participating in the Agency's activities 1. The Agency may, with the agreement of the Member States concerned, invite observers of Union institutions, bodies, offices, agencies or international organisations and CSDP missions and operations referred to in point (j) of the second subparagraph of Article 68(1) to participate in its activities, in particular in joint operations and pilot projects, risk analysis and training, to the extent that their presence is in accordance with the objectives of those activities, may contribute to the improvement of cooperation and the exchange of best practices, and does not affect the overall safety and security of those activities. The participation of such observers in risk analysis and training may take place only with the agreement of the Member States concerned. As regards joint operations and pilot projects, the participation of observers shall be subject to the agreement of the host Member State. Detailed rules on the participation of observers shall be included in the operational plan. Those observers shall receive appropriate training from the Agency prior to their participation. 2. The Agency may, with the agreement of the Member States concerned, invite observers from third countries to participate in its activities at the external borders, return operations, return interventions and training, as referred to in Article 62, to the extent that their presence is in accordance with the objectives of those activities, may contribute to improving cooperation and the exchange of best practices, and does not affect the overall safety of those activities or the safety of third-country nationals. Detailed rules on the participation of observers shall be included in the operational plan. Those observers shall receive appropriate training from the Agency prior to their participation. They shall be required to adhere to the codes of conduct of the Agency while participating in its activities. 3. The Agency shall ensure that the presence of observers does not pose any risk related to respect for fundamental rights. CHAPTER III FALSE AND AUTHENTIC DOCUMENTS ONLINE (FADO) Article 79 The Agency shall take over and operate the False and Authentic Documents Online (\u2018FADO\u2019) system established in accordance with Joint Action 98/700/JHA. CHAPTER IV GENERAL PROVISIONS SECTION 1 General rules Article 80 Protection of fundamental rights and a fundamental rights strategy 1. The European Border and Coast Guard shall guarantee the protection of fundamental rights in the performance of its tasks under this Regulation in accordance with relevant Union law, in particular the Charter, and relevant international law, including the 1951 Convention relating to the Status of Refugees, the 1967 Protocol thereto, the Convention on the Rights of the Child and obligations related to access to international protection, in particular the principle of non-refoulement. For that purpose, the Agency, with the contribution of and subject to the endorsement by the fundamental rights officer, shall draw up, implement and further develop a fundamental rights strategy and action plan, including an effective mechanism for monitoring respect for fundamental rights in all the activities of the Agency. 2. In the performance of its tasks, the European Border and Coast Guard shall ensure that no person, in contravention of the principle of non-refoulement, be forced to disembark in, forced to enter, or conducted to a country, or be otherwise handed over or returned to the authorities of a country where there is, inter alia, a serious risk that he or she would be subjected to the death penalty, torture, persecution, or other inhuman or degrading treatment or punishment, or where his or her life or freedom would be threatened on account of his or her race, religion, nationality, sexual orientation, membership of a particular social group or political opinion, or from which there is a risk of expulsion, removal, extradition or return to another country in contravention of the principle of non-refoulement. 3. In the performance of its tasks, the European Border and Coast Guard shall take into account the special needs of children, unaccompanied minors, persons with disabilities, victims of trafficking in human beings, persons in need of medical assistance, persons in need of international protection, persons in distress at sea and other persons in a particularly vulnerable situation, and shall address those needs within its mandate. The European Border and Coast Guard shall in all its activities pay particular attention to children's rights and ensure that the best interests of the child are respected. 4. In the performance of its tasks, in its relations with Member States and in its cooperation with third countries, the Agency shall take into account the reports of the consultative forum referred to in Article 108 and the reports of the fundamental rights officer. Article 81 Code of conduct 1. The Agency shall, in cooperation with the consultative forum, draw up and further develop a code of conduct which shall apply to all border control operations coordinated by the Agency and all persons participating in the activities of the Agency. The code of conduct shall lay down procedures intended to guarantee the principles of the rule of law and respect for fundamental rights with particular focus on vulnerable persons, including children, unaccompanied minors and other persons in a vulnerable situation, as well as on persons seeking international protection. 2. The Agency shall, in cooperation with the consultative forum, draw up and further develop a code of conduct for return operations and return interventions, which shall apply during all return operations and return interventions coordinated or organised by the Agency. That code of conduct shall describe common standardised procedures to simplify the organisation of return operations and return interventions, and shall assure return in a humane manner and with full respect for fundamental rights, in particular the principles of human dignity, the prohibition of torture and of inhuman or degrading treatment or punishment, the right to liberty and security and the right to the protection of personal data and non-discrimination. 3. The code of conduct for return shall in particular pay attention to the obligation of Member States to provide for an effective forced-return monitoring system as set out in Article 8(6) of Directive 2008/115/EC and to the fundamental rights strategy. Article 82 Tasks and powers of the members of the teams 1. Members of the teams shall have the capacity to perform tasks and exercise powers for border control and return as well as those which are necessary for the realisation of the objectives of Regulations (EU) No 656/2014 and (EU) 2016/399 and Directive 2008/115/EC. 2. The performance of tasks and the exercise of powers by members of the teams, in particular those requiring executive powers, shall be subject to the authorisation of the host Member State on its territory as well as to applicable Union, national or international law, in particular Regulation (EU) No 656/2014, as described in the operational plans referred to in Article 38. 3. While performing their tasks and exercising their powers, members of the teams shall fully ensure respect for fundamental rights and shall comply with Union and international law and the national law of the host Member State. 4. Without prejudice to Article 95(1) as regards statutory staff, members of the teams shall only perform tasks and exercise powers under instructions from and, as a general rule, in the presence of border guards or staff involved in return-related tasks of the host Member State. The host Member State may authorise members of the teams to act on its behalf. 5. The host Member State may report incidents related to non-compliance with the operational plan by members of the teams, including in relation to fundamental rights, to the Agency via the coordinating officer for possible follow-up, which may include disciplinary measures. 6. Statutory staff who are members of the teams shall wear the uniform of the standing corps while performing their tasks and exercising their powers. Members of the teams who are seconded from Member States for a long term or who are deployed for a short term shall wear their own uniform while performing their tasks and exercising their powers. By way of derogation from the first subparagraph of this paragraph, the decision of the management board referred to in point (a) of Article 54(4) shall indicate the profiles to which the obligation to wear a uniform does not apply due to the specific nature of the operational activity. All members of the teams shall wear visible personal identification and a blue armband with the insignias of the Union and of the Agency on their uniforms, identifying them as participating in a joint operation, migration management support team deployment, pilot project, rapid border intervention, return operation or return intervention. For the purposes of identification vis-\u00e0-vis the national authorities of the host Member State, members of the teams shall at all times carry an accreditation document, which they shall present upon request. The design and specifications for the uniforms of the statutory staff shall be established by a decision of the management board, on the basis of a proposal from the executive director made after receiving the opinion of the Commission. 7. For staff who are seconded to the Agency or deployed from a Member State for a short term, the ability to carry and use service weapons, ammunition and equipment shall be subject to the home Member State's national law. The ability to carry and use service weapons, ammunition and equipment by the statutory staff who are deployed as members of the teams shall be subject to the framework and detailed rules laid down in this Article and Annex V. For the purpose of implementing this paragraph, the executive director may authorise statutory staff to carry and use weapons in accordance with the rules adopted by the management board, in line with point (b) of Article 55(5). 8. Members of the teams, including statutory staff, shall be authorised for the relevant profiles by the host Member State to perform tasks during a deployment that require the use of force, including the carrying and use of service weapons, ammunition and equipment, and shall be subject to the consent of either the home Member State or, for statutory staff, the Agency. The use of force, including the carrying and use of service weapons, ammunition and equipment, shall be exercised in accordance with the national law of the host Member State and in the presence of border guards of the host Member State. The host Member State may, with the consent of the home Member State or the Agency, where appropriate, authorise members of the teams to use force on its territory in the absence of border guards of the host Member State. The host Member State may prohibit the carrying of certain service weapons, ammunition and equipment, provided that its own law applies the same prohibition to its own border guards or staff when involved in return-related tasks. The host Member State, in advance of the deployment of the members of the teams, shall inform the Agency of the permissible service weapons, ammunition and equipment and of the conditions for their use. The Agency shall make this information available to Member States. 9. Service weapons, ammunition and equipment may be used in legitimate self-defence and in legitimate defence of members of the teams or of other persons in accordance with the national law of the host Member State in line with relevant principles of international human rights law and the Charter. 10. For the purpose of this Regulation, the host Member State shall authorise members of the teams to consult Union databases, the consultation of which is necessary for fulfilling operational aims specified in the operational plan on border checks, border surveillance and return, through their national interfaces or another form of access provided in the Union legal acts establishing such databases, as applicable. The host Member State may also authorise members of the teams to consult its national databases where necessary for the same purpose. Member States shall ensure that they provide such database access in an efficient and effective manner. Members of the teams shall consult only those data which are strictly necessary for performing their tasks and exercising their powers. The host Member State shall, in advance of the deployment of the members of the teams, inform the Agency of the national and Union databases which may be consulted. The Agency shall make this information available to all Member States participating in the deployment. That consultation shall be carried out in accordance with Union data protection law and the national data protection law of the host Member State. 11. Decisions to refuse entry in accordance with Article 14 of Regulation (EU) 2016/399 and decisions refusing visas at the border in accordance with Article 35 of Regulation (EC) No 810/2009 shall be taken only by border guards of the host Member State or by members of the teams if they are authorised by the host Member State to act on its behalf. Article 83 Accreditation document 1. The Agency shall, in cooperation with the host Member State, issue a document in the official language of the host Member State and another official language of the institutions of the Union to the members of the teams for the purpose of identifying them and as proof of the holder's rights to perform tasks and exercise powers as referred to in Article 82. That document shall include the following features of each member of the teams: (a) name and nationality; (b) rank or job title; (c) a recent digitised photograph; and (d) tasks authorised to be performed during the deployment. 2. The document shall be returned to the Agency at the end of each joint operation, migration management support team deployment, pilot project, rapid border intervention, return operation or return intervention. Article 84 Civil liability of the members of the team 1. Without prejudice to Article 95, where members of the teams are operating in a host Member State, that Member State shall be liable in accordance with its national law for any damage caused by them during their operations. 2. Where such damage is caused by the gross negligence or wilful misconduct of the members of the teams seconded or deployed by the Member States, the host Member State may request the home Member State to reimburse it for any sums that the host Member State has paid to the injured parties or persons entitled to receive such sums on behalf of the injured parties. Where such damage is caused by gross negligence or wilful misconduct by the statutory staff, the host Member State may request the Agency to reimburse it for any sums that the host Member State has paid to the injured parties or persons entitled to receive such sums on behalf of the injured parties. This shall be without prejudice to any action before the Court of Justice of the European Union (the \u2018Court of Justice\u2019) against the Agency in accordance with Article 98. 3. Without prejudice to the exercise of its rights vis-\u00e0-vis third parties, each Member State shall waive all its claims against the host Member State or any other Member State for any damage it has sustained, except in cases of gross negligence or wilful misconduct. 4. Any dispute between Member States, or between a Member State and the Agency, relating to the application of paragraphs 2 and 3 of this Article which cannot be resolved by negotiations between them shall be submitted by them to the Court of Justice. 5. Without prejudice to the exercise of its rights vis-\u00e0-vis third parties, the Agency shall bear the costs of damage to its equipment during deployment, except in cases of gross negligence or wilful misconduct. Article 85 Criminal liability of the members of the teams Without prejudice to Article 95, during a joint operation, pilot project, migration management support team deployment, rapid border intervention, return operation or return intervention, members of the teams in the territory of the host Member State, including statutory staff, shall be treated in the same way as officials of the host Member State with regard to any criminal offences that might be committed against them or by them. SECTION 2 Processing of personal data by the European Border and Coast Guard Article 86 General rules on processing of personal data by the Agency 1. The Agency shall apply Regulation (EU) 2018/1725 when processing personal data. 2. The management board shall adopt internal rules on the application of Regulation (EU) 2018/1725 by the Agency, including rules concerning the data protection officer of the Agency. The Agency may, in accordance with Article 25 of Regulation (EU) 2018/1725, adopt internal rules restricting the application of Articles 14 to 22, 35 and 36 of that Regulation. In particular, the Agency may, for the performance of its tasks in the area of return, provide for internal rules restricting the application of those provisions on a case-by-case basis as long as the application of those provisions would risk jeopardising return procedures. Such restrictions shall respect the essence of the fundamental rights and freedoms, shall be necessary and proportionate to the objectives pursued and shall contain specific provisions, where relevant, as referred to in Article 25(2) of Regulation (EU) 2018/1725. 3. The Agency may transfer the personal data referred to in Articles 49, 88 and 89 to a third country or to an international organisation in accordance with Chapter V of Regulation (EU) 2018/1725 insofar as such transfer is necessary for the performance of the Agency's tasks. The Agency shall ensure that personal data that are transferred to a third country or to an international organisation are only processed for the purpose for which they were provided. The Agency shall indicate, at the moment of transferring personal data to a third country or to an international organisation, any restrictions on access to or use of those data, in general or specific terms, including as regards transfer, erasure or destruction. Where the need for such restrictions becomes apparent after the transfer of personal data, the Agency shall inform the third country or the international organisation accordingly. The Agency shall ensure that the third country or international organisation concerned complies with such restrictions. 4. Transfers of personal data to third countries shall not prejudice the rights of applicants for international protection and of beneficiaries of international protection, in particular as regards non-refoulement and the prohibition against disclosing or obtaining information set out in Article 30 of Directive 2013/32/EU of the European Parliament and of the Council (43). 5. Member States and the Agency, as appropriate, shall ensure that information that is transferred or disclosed to third countries pursuant to this Regulation is not transmitted onward to other third countries or third parties. Provisions to that effect shall be included in any agreement or arrangement concluded with a third country providing for the exchange of information. Article 87 Purposes of processing of personal data 1. The Agency may process personal data only for the following purposes: (a) performing its tasks of organising and coordinating joint operations, pilot projects, rapid border interventions and in the framework of the migration management support teams as referred to in Articles 37 to 40; (b) performing its tasks of supporting Member States and third countries in pre-return and return activities, operating return management systems, as well as coordinating or organising return operations and providing technical and operational assistance to Member States and third countries in accordance with Article 48; (c) facilitating the exchange of information with Member States, the Commission, the EEAS and the following Union bodies, offices and agencies and international organisations: EASO, the European Union Satellite Centre, EFCA, EMSA, EASA and the Network Manager of the EATMN, in accordance with Article 88; (d) facilitating the exchange of information with the law enforcement authorities of the Member States, Europol or Eurojust in accordance with Article 90; (e) risk analysis by the Agency in accordance with Article 29; (f) performing its tasks in the framework of EUROSUR in accordance with Article 89; (g) operating the FADO system in accordance with Article 79; (h) administrative tasks. 2. Member States and their law enforcement authorities, the Commission, the EEAS, and those Union bodies, offices and agencies and international organisations referred to in points (c) and (d) of paragraph 1, that provide personal data to the Agency shall determine the purpose or the purposes for which those data are to be processed as referred to in paragraph 1. The Agency may decide to process such personal data for a different purpose which also falls under paragraph 1 only on a case-by-case basis after having determined that such processing is compatible with the initial purpose for which the data were collected and if authorised by the provider of the personal data. The Agency shall keep written records of case-by-case compatibility assessments. 3. The Agency, the Member States and their law enforcement authorities, the Commission, the EEAS, and those Union bodies, offices and agencies and international organisations referred to in points (c) and (d) of paragraph 1, may indicate, at the moment of transmitting personal data, any restrictions on access to those data or use of such data, in general or specific terms, including as regards the transfer, erasure or destruction of such data. Where the need for such restrictions becomes apparent after the transfer of personal data, they shall inform the recipients accordingly. The recipients shall comply with such restrictions. Article 88 Processing of personal data collected during joint operations, return operations, return interventions, pilot projects, rapid border interventions, and migration management support team deployments 1. Before each joint operation, return operation, return intervention, pilot project, rapid border intervention or migration management support team deployment, the Agency and the host Member State shall determine in a transparent manner the responsibilities for compliance with the data protection obligations. When the purpose and the means of processing are jointly determined by the Agency and the host Member State, they shall be joint controllers by means of concluding an arrangement between them. For the purposes referred to in points (a), (b), (c), (e) and (f) of Article 87(1), the Agency shall only process the following categories of personal data collected by the Member States, by members of the teams, by its staff or by EASO that have been transmitted to it in the context of joint operations, return operations, return interventions, pilot projects, rapid border interventions, and migration management support team deployments: (a) the personal data of persons who cross the external borders without authorisation; (b) personal data that are necessary to confirm the identity and nationality of third-country nationals within the framework of the return activities, including passenger lists; (c) licence plate numbers, vehicle identification numbers, telephone numbers or ship and aircraft identification numbers which are linked to the persons referred to in point (a), and which are necessary for analysing routes and methods used for illegal immigration. 2. The personal data referred to in paragraph 1 may be processed by the Agency in the following cases: (a) where the transmission of those data to the authorities of the relevant Member States which are responsible for border control, migration, asylum or return, or to relevant Union bodies, offices and agencies, is necessary for those authorities or Union bodies, offices and agencies to fulfil their tasks in accordance with Union and national law; (b) where transmission of those data to the authorities of relevant Member States, relevant Union bodies, offices and agencies, third countries of return or international organisations is necessary for the purpose of identifying third-country nationals, acquiring travel documents or enabling or supporting return; (c) where necessary for the preparation of risk analyses. Article 89 Processing of personal data in the framework of EUROSUR 1. Where the national situational picture requires the processing of personal data, those data shall be processed in accordance with Regulation (EU) 2016/679 and, where applicable, Directive (EU) 2016/680. Each Member State shall designate the authority which is to be considered as controller within the meaning of point 7 of Article 4 of Regulation (EU) 2016/679 or point (8) of Article 3 of Directive (EU) 2016/680, as applicable, and which shall have central responsibility for the processing of personal data by that Member State. Each Member State shall notify the details of that authority to the Commission. 2. Ship and aircraft identification numbers shall be the only personal data that are permitted to be accessed in the European situational and specific situational pictures and the EUROSUR fusion services. 3. Where the processing of information in EUROSUR exceptionally requires the processing of personal data other than ship and aircraft identification numbers, any such processing shall be strictly limited to what is necessary for the purposes of EUROSUR in accordance with Article 18. 4. Any exchange of personal data with third countries in the framework of EUROSUR shall be strictly limited to what is absolutely necessary for the purposes of this Regulation. It shall be carried out in accordance with Chapter V of Regulation (EU) 2018/1725 by the Agency, and in accordance with Chapter V of Regulation (EU) 2016/679, with Chapter V of Directive (EU) 2016/680, as applicable, and with the relevant national provisions on data protection transposing that Directive, by the Member States. 5. Any exchange of information under Articles 72(2), 73(3) and 74(3) which provides a third country with data that could be used to identify persons or groups of persons whose request for access to international protection is under examination or who are under a serious risk of being subjected to torture, inhuman and degrading treatment or punishment, or any other violation of fundamental rights, shall be prohibited. 6. Member States and the Agency shall keep records of processing activities in accordance with, Article 30 of Regulation (EU) 2016/679, Article 24 of Directive (EU) 2016/680, and Article 31 of Regulation (EU) 2018/1725, as applicable. Article 90 Processing of operational personal data 1. Where the Agency, in the performance of its tasks under point (q) of Article 10(1) of this Regulation, processes personal data which it has collected while monitoring migratory flows, carrying out risk analyses or in the course of operations for the purpose of identifying suspects of cross-border crime, it shall process such personal data in accordance with Chapter IX of Regulation (EU) 2018/1725. Personal data processed for that purpose, including licence plate numbers, vehicle identification numbers, telephone numbers and ship or aircraft identification numbers which are linked to such persons, shall relate to natural persons whom the competent authorities of the Member States, Europol, Eurojust, or the Agency have reasonable grounds to suspect are involved in cross-border crime. Such personal data may include personal data of victims or witnesses where those personal data supplement the personal data of suspects processed by the Agency in accordance with this Article. 2. The Agency shall only exchange personal data as referred to in paragraph 1 of this Article with: (a) Europol or Eurojust where they are strictly necessary for the performance of their respective mandates and in accordance with Article 68; (b) the competent law enforcement authorities of the Member States where they are strictly necessary for those authorities for the purposes of preventing, detecting, investigating or prosecuting serious cross-border crime. Article 91 Data retention 1. The Agency shall delete personal data as soon as they have been transmitted to the competent authorities of Member States, other Union bodies, offices and agencies, in particular EASO, or transferred to third countries or international organisations or used for the preparation of risk analyses. The retention period shall, in any event, not exceed 90 days after the date of the collection of those data. Data shall be anonymised in the results of risk analyses. 2. Personal data processed for the purpose of performing return-related tasks shall be deleted as soon as the purpose for which they have been collected has been achieved, and shall be deleted no later than 30 days after the end of those tasks. 3. Operational personal data processed for the purposes of Article 90 shall be deleted as soon as the purpose for which they have been collected has been achieved by the Agency. The Agency shall continuously review the necessity of storing such data, in particular the personal data of victims and witnesses. In any case, the Agency shall review the necessity of storing such data no later than three months after the start of initial processing of such data, and every six months thereafter. The Agency shall decide on the continued storage of personal data, in particular the personal data of victims and witnesses, until the following review, only if such storage is still necessary for the performance of the Agency's tasks under Article 90. 4. This Article does not apply to personal data collected in the context of the FADO system. Article 92 Security rules on the protection of classified information and sensitive non-classified information 1. The Agency shall adopt its own security rules that shall be based on the principles and rules laid down in the Commission's security rules for protecting European Union classified information (EUCI) and sensitive non-classified information including, inter alia, provisions for the exchange of such information with third countries, and processing and storage of such information as set out in Commission Decisions (EU, Euratom) 2015/443 (44) and (EU, Euratom) 2015/444 (45). Any administrative arrangement on the exchange of classified information with the relevant authorities of a third country or, in the absence of such arrangement, any exceptional ad hoc release of EUCI to those authorities, shall be subject to the Commission's prior approval. 2. The management board shall adopt the Agency's security rules following approval by the Commission. When assessing the proposed security rules, the Commission shall ensure that they are compatible with Decisions (EU, Euratom) 2015/443 and (EU, Euratom) 2015/444. 3. Classification shall not preclude information being made available to the European Parliament. The transmission and handling of information and documents transmitted to the European Parliament in accordance with this Regulation shall comply with the rules concerning the forwarding and handling of classified information which are applicable between the European Parliament and the Commission. SECTION 3 General framework and organisation of the Agency Article 93 Legal status and location 1. The Agency shall be a body of the Union. It shall have legal personality. 2. In each of the Member States, the Agency shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property and may be party to legal proceedings. 3. The Agency shall be independent in implementing its technical and operational mandate. 4. The Agency shall be represented by its executive director. 5. The seat of the Agency shall be Warsaw, Poland. Article 94 Headquarters agreement 1. The necessary arrangements concerning the accommodation to be provided for the Agency in the Member State in which the Agency has its seat and the facilities to be made available by that Member State, as well as the specific rules applicable to the executive director, the deputy executive directors, the members of the management board, Agency staff and members of their families in that Member State shall be laid down in a headquarters agreement between the Agency and the Member State in which the Agency has its seat. 2. The headquarters agreement shall be concluded after obtaining the approval of the management board. 3. The Member State in which the Agency has its seat shall provide the best possible conditions to ensure the proper functioning of the Agency, including multilingual, European-oriented schooling and appropriate transport connections. Article 95 Staff 1. The Staff Regulations, the Conditions of Employment and the rules adopted in agreement between the institutions of the Union for giving effect to those Staff Regulations and those Conditions of Employment shall apply to statutory staff. 2. The place of employment shall in principle be the Member State where the Agency's seat is located. 3. Statutory staff who are subject to the Conditions of Employment shall in principle be engaged initially for a fixed period of five years. Their contracts may in principle be renewed only once, for a fixed period of a maximum of five years. Any further renewal shall be for an indefinite period. 4. For the purpose of implementing Articles 31 and 44, only statutory staff who are subject to the Staff Regulations or to Title II of the Conditions of Employment may be appointed as liaison officers or coordinating officers. For the purpose of implementing Article 55, only statutory staff who are subject to the Staff Regulations or of the Conditions of Employment may be deployed as members of the teams. 5. The management board shall adopt implementing rules for giving effect to the Staff Regulations and Conditions of Employment in agreement with the Commission pursuant to Article 110(2) of the Staff Regulations. 6. Subject to prior approval by the Commission, the management board shall adopt rules related to staff from Member States to be seconded to the Agency in accordance with Article 56 and update them as necessary. Those rules shall include, in particular, the financial arrangements related to those secondments, including insurance, and training. Those rules shall take into account the fact that the staff are seconded to be deployed as members of the teams and are to have the tasks and powers provided for in Article 82. Such rules shall include provisions on the conditions of deployment. Where relevant, the management board shall aim to ensure consistency with the rules applicable to reimbursement of the mission expenses of the statutory staff. Article 96 Privileges and immunities Protocol No 7 on the Privileges and Immunities of the European Union annexed to the Treaty on European Union (TEU) and to the TFEU shall apply to the Agency and its statutory staff. Article 97 Liability 1. Without prejudice to Articles 84 and 85, the Agency shall be liable for any activities it has undertaken in accordance with this Regulation. 2. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. 3. The Court of Justice shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by the Agency. 4. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its departments or by its staff in the performance of their duties, including those related to the use of executive powers. 5. The Court of Justice shall have jurisdiction in disputes relating to compensation for the damage referred to in paragraph 4. 6. The personal liability of statutory staff towards the Agency shall be governed by the provisions laid down in the Staff Regulations and Conditions of Employment applicable to them. Article 98 Actions before the Court of Justice 1. Proceedings may be brought before the Court of Justice for the annulment of acts of the Agency that are intended to produce legal effects vis-\u00e0-vis third parties, in accordance with Article 263 TFEU, and for failure to act, in accordance with Article 265 TFEU, for non-contractual liability for damages caused by the Agency and, pursuant to an arbitration clause, contractual liability for damages caused by acts of the Agency, in accordance with Article 340 TFEU. 2. The Agency shall take the necessary measures to comply with judgments of the Court of Justice. Article 99 Administrative and management structure of the Agency The administrative and management structure of the Agency shall include: (a) a management board; (b) an executive director; (c) deputy executive directors; and (d) a fundamental rights officer; A consultative forum shall assist the Agency as an advisory body. Article 100 Functions of the management board 1. The management board shall be responsible for taking the strategic decisions of the Agency in accordance with this Regulation. 2. The management board shall: (a) appoint the executive director on the basis of a proposal from the Commission in accordance with Article 107; (b) appoint the deputy executive directors on the basis of a proposal from the Commission in accordance with Article 107; (c) adopt decisions on establishing antenna offices or prolonging the duration of their operation in accordance with Article 60(5) by a majority of two thirds of the members with a right to vote; (d) adopt decisions on conducting the vulnerability assessment in accordance with Article 32(1) and (10), with the decisions setting out measures adopted under Article 32(10) being passed by a majority of two thirds of the members with a right to vote; (e) adopt decisions on the lists of mandatory information and data to be exchanged with the Agency by the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return, to enable the Agency to perform its tasks, without prejudice to obligations established by this Regulation, in particular by Articles 49 and 86 to 89; (f) adopt decisions on the establishment of a common integrated risk analysis model in accordance with Article 29(1); (g) adopt decisions on the nature and terms of the deployment of liaison officers in Member States in accordance with Article 31(2); (h) adopt a technical and operational strategy for European integrated border management in accordance with Article 8(5); (i) adopt decisions on the profiles and the numbers of operational staff for the management of borders and migration within the standing corps, in accordance with Article 54(4); (j) adopt the Agency's annual activity report for the previous year and transmit it, by 1 July of each year at the latest, to the European Parliament, to the Council, to the Commission and to the Court of Auditors; (k) before 30 November of each year, and after duly taking into account the opinion of the Commission, adopt, by a majority of two thirds of the members with a right to vote, a single programming document containing, inter alia, the Agency's multiannual programming and its work programme for the following year and forward it to the European Parliament, to the Council and to the Commission; (l) establish procedures for the executive director to take decisions relating to the technical and operational tasks of the Agency; (m) adopt, by a majority of two thirds of the members with a right to vote, the annual budget of the Agency and exercise other functions in respect of the Agency's budget pursuant to Section 4 of this Chapter; (n) exercise disciplinary authority over the executive director and, in consultation with the executive director, over the deputy executive directors; (o) establish its rules of procedure; (p) establish the organisational structure of the Agency and adopt the Agency's staff policy; (q) adopt an anti-fraud strategy that is proportionate to the risk of fraud, taking into account the costs and benefits of the measures to be implemented; (r) adopt internal rules for the prevention and management of conflicts of interest in respect of its members; (s) exercise, in accordance with paragraph 8, with respect to statutory staff, the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment on the Authority Empowered to Conclude a Contract of Employment (the \u2018appointing-authority powers\u2019); (t) adopt implementing rules for giving effect to the Staff Regulations and the Conditions of Employment in accordance with Article 110(2) of the Staff Regulations; (u) ensure adequate follow-up to findings and recommendations stemming from the internal or external audit reports and evaluations, as well as from investigations of the European Anti-Fraud Office (OLAF); (v) adopt and regularly update the communication and dissemination plans referred to in the second subparagraph of Article 10(2); (w) appoint an accounting officer, subject to the Staff Regulations and the Conditions of Employment, who shall be completely independent in the performance of his or her duties; (x) decide on a common vulnerability assessment methodology, including the objective criteria against which the Agency shall carry out the vulnerability assessment, the frequency of such assessments and how consecutive vulnerability assessments are to be carried out; (y) decide on enhanced assessment and monitoring of a Member State as referred to in Article 32(2); (z) appoint the fundamental rights officer and a deputy fundamental rights officer in accordance with Article 109; (aa) establish special rules in order to guarantee the independence of the fundamental rights officer in the performance of his or her duties; (ab) approve the working arrangements with third countries; (ac) subject to the prior approval of the Commission, adopt the security rules of the Agency on protecting EUCI and sensitive non-classified information as referred to in Article 92; (ad) appoint a security officer, subject to the Staff Regulations and the Conditions of Employment, who shall be responsible for the security within the Agency, including for the protection of classified information and sensitive non-classified information; (ae) decide on any other matter where provided for in this Regulation. The annual activity report referred to in point (j) shall be made public. 3. Proposals for decisions of the management board, as referred to in paragraph 2, on specific activities of the Agency to be carried out at, or in the immediate vicinity of, the external borders of any particular Member State or on working arrangements with third countries as referred to in Article 73(4) shall require a vote in favour of their adoption by the member of the management board representing that particular Member State or the Member State neighbouring that third country, respectively. 4. The management board may advise the executive director on any matter related to the development of operational management of the external borders and training, including activities related to research. 5. Should Ireland or the United Kingdom request to participate in specific activities, the management board shall decide thereon. The management board shall take its decisions on a case-by-case basis. In its decisions, the management board shall consider whether the participation of Ireland or the United Kingdom contributes to the achievement of the activity in question. The decisions shall set out the financial contribution of Ireland or the United Kingdom to the activity for which the request for participation has been made. 6. The management board shall forward annually to the European Parliament and to the Council (\u2018the budgetary authority\u2019) any information relevant to the outcome of the evaluation procedures conducted by the Agency. 7. The management board may establish an executive board composed of up to four representatives of the management board, including its chairperson, and a representative of the Commission, to assist it and the executive director with regard to the preparation of the decisions, programmes and activities to be adopted by the management board and to take certain provisional, urgent decisions on behalf of the management board when necessary. The executive board shall not take decisions that must be passed by a majority of two thirds of the management board. The management board may delegate certain clearly defined tasks to the executive board, in particular where this improves the efficiency of the Agency. It may not delegate to the executive board tasks related to decisions that must be passed by a majority of two thirds of the management board. 8. The management board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment, delegating relevant appointing-authority powers to the executive director and setting out the conditions under which this delegation of powers can be suspended. The executive director shall be authorised to sub-delegate those powers. Where exceptional circumstances so require, the management board may by way of a decision temporarily suspend the delegation of the appointing-authority powers to the executive director and those sub-delegated by the latter. It may then exercise them itself or delegate them to one of its members or to a statutory staff member other than the executive director. Article 101 Composition of the management board 1. Without prejudice to paragraph 3, the management board shall be composed of one representative of each Member State and two representatives of the Commission, each with a right to vote. To this effect, each Member State shall appoint a member of the management board as well as an alternate who will represent the member in his or her absence. The Commission shall appoint two members and two alternates. The duration of the terms of office shall be four years. The terms of office shall be extendable. 2. The management board members shall be appointed on the basis of the degree of their relevant high-level experience, their expertise in the field of operational cooperation on border management and return, and their relevant managerial, administrative and budgetary skills. Member States and the Commission shall aim to achieve a gender-balanced representation on the management board. 3. Countries associated with the implementation, application and development of the Schengen acquis shall participate in the Agency. They shall each have one representative and one alternate on the management board. The arrangements developed under the relevant provisions of their association agreements that specify the nature and extent of, and the detailed rules for, the participation by those countries in the work of the Agency, including provisions on financial contributions and staff, shall apply. Article 102 Multiannual programming and annual work programmes 1. The management board shall, by 30 November of each year, adopt a single programming document containing, inter alia, the Agency's multiannual programming and annual programming for the following year, on the basis of a draft put forward by the executive director and endorsed by the management board. The single programming document shall be adopted taking into account a positive opinion of the Commission and, as regards the multiannual programming, after having consulted the European Parliament and the Council. If the management board decides not to take into account elements of the opinion of the Commission, it shall provide a thorough justification. The obligation to provide a thorough justification shall also apply to the elements raised by the European Parliament and the Council during the consultation. The management board shall forward the document to the European Parliament, to the Council and to the Commission without delay. 2. The document referred to in paragraph 1 shall become definitive after the final adoption of the general budget. It shall be adjusted accordingly where necessary. 3. In line with the multiannual strategic policy cycle for European integrated border management, the multiannual programming shall set out overall strategic programming for the medium and long term, which shall include objectives, expected results, performance indicators and resource planning, including the multiannual budget, staff and the development of the Agency's own capabilities, including indicative multiannual planning of the profiles of staff for the standing corps. The multiannual programming shall set out the strategic areas of intervention and what needs to be done to achieve the objectives. It shall include strategic actions for the implementation of the fundamental rights strategy referred to in Article 80(1) and a strategy for relations with third countries and international organisations as well as the actions linked to that strategy. 4. The multiannual programming shall be implemented by means of annual work programmes and shall, where appropriate, be updated following the outcome of an evaluation conducted pursuant to Article 121. The conclusion of those evaluations shall also be reflected, where appropriate, in the annual work programme for the following year. 5. The annual work programme shall contain a description of the activities to be financed, comprising detailed objectives and expected results, including performance indicators. It shall also contain an indication of the financial and human resources allocated to each activity, in accordance with the principles of activity-based budgeting and management. The annual work programme shall be consistent with the multiannual programming. It shall clearly indicate tasks that have been added, changed or deleted compared with the previous financial year. 6. The annual work programme shall be adopted in accordance with the Union legislative programme in relevant areas of the management of the external borders and return. 7. Where, after adoption of an annual work programme, a new task is assigned to the Agency, the management board shall amend the annual work programme. 8. Any substantial amendment to the annual work programme, especially a modification resulting in a reallocation of the budgetary resources above 2 % of the annual budget, shall be adopted by the same procedure as that applicable to adoption of the initial annual work programme. The management board may delegate to the executive director the power to make non-substantial amendments to the annual work programme. Article 103 Chair of the management board 1. The management board shall elect a chairperson and a deputy chairperson from among its members with a right to vote. The chairperson and the deputy chairperson shall be elected by a majority of two thirds of the members of the management board with a right to vote. The deputy chairperson shall ex officio replace the chairperson in the event of his or her being prevented from attending to his or her duties. 2. The terms of office of the chairperson and deputy chairperson shall expire when their respective membership of the management board ceases. Subject to this provision, the terms of office of the chairperson or deputy chairperson shall be four years. Those terms of office shall be extendable once. Article 104 Meetings of the management board 1. Meetings of the management board shall be convened by its chairperson. 2. The executive director shall take part in the deliberations without the right to vote. 3. The management board shall hold at least two ordinary meetings a year. In addition, it shall meet at the initiative of the chairperson, at the request of the Commission, or at the request of at least one third of the members of the management board. Where necessary, the management board may hold joint meetings with the management boards of EASO and Europol. 4. Ireland shall be invited to attend the meetings of the management board. 5. The United Kingdom shall be invited to attend meetings of the management board that take place before the day on which the Treaties cease to apply to the United Kingdom pursuant to Article 50(3) TEU. 6. Representatives of EASO and Europol shall be invited to attend the meetings of the management board. A representative of FRA shall be invited to attend meetings of the management board where points relevant to the protection of fundamental rights are on the agenda. 7. The chairperson of the management board may also invite an expert of the European Parliament to attend the meetings of the management board. The management board may also invite representatives of other relevant Union institutions, bodies, offices and agencies. The management board may invite, in accordance with its rules of procedure, any other person whose opinion may be of interest to attend its meetings as an observer. 8. The members of the management board may, subject to the provisions of its rules of procedure, be assisted by advisers or experts. 9. The secretariat for the management board shall be provided by the Agency. Article 105 Voting 1. Without prejudice to points (c), (d), (k) and (m) of Article 100(2), Article 103(1), and Article 107(2) and (4), the management board shall take its decisions by an absolute majority of its members with a right to vote. 2. Each member shall have one vote. In the absence of a member, his or her alternate shall be entitled to exercise his or her right to vote. The executive director shall not vote. 3. The rules of procedure shall set out the voting arrangements in greater detail. Those rules shall include the conditions for a member to act on behalf of another member as well as any quorum requirements. 4. Representatives of countries associated with the implementation, application and development of the Schengen acquis shall have limited voting rights corresponding to their respective arrangements. In order to allow the associated countries to exercise their right to vote, the Agency shall detail the agenda identifying the points for which a limited voting right has been granted. Article 106 Functions and powers of the executive director 1. The Agency shall be managed by its executive director, who shall be completely independent in the performance of his or her duties. Without prejudice to the respective competencies of the Union institutions and the management board, the executive director shall neither seek nor take instructions from any government or from any other body. 2. The European Parliament or the Council may invite the executive director to report on the carrying out of his or her tasks. This includes reporting on the activities of the Agency, the implementation and monitoring of the fundamental rights strategy, the annual activity report of the Agency for the previous year, the work programme for the following year and the Agency's multiannual programming and any other matter related to the activities of the Agency. The executive director shall also make a statement before the European Parliament, if requested, and shall answer in writing any question put forward by a Member of the European Parliament within 15 calendar days from receipt of such question. The executive director shall report regularly to the appropriate bodies and committees of the European Parliament. 3. Except where specific deadlines are provided for in this Regulation, the executive director shall ensure that reports are transmitted to the European Parliament, to the Council and to the Commission as soon as possible, and in any event within six months of the end of the reporting period, unless the executive director duly justifies a delay in writing. 4. The executive director shall be responsible for the preparation and implementation of the strategic decisions taken by the management board and for the taking of decisions related to the operational activities of the Agency in accordance with this Regulation. The executive director shall have the following functions and powers: (a) to propose, prepare and implement the strategic decisions and programmes and activities adopted by the management board within the limits set out in this Regulation, its implementing rules and any applicable law; (b) to take all necessary steps, including the adoption of internal administrative instructions and the publication of notices, to ensure the day-to-day administration and functioning of the Agency in accordance with this Regulation; (c) to prepare each year the draft single programming document and to submit it to the management board for endorsement before that draft is sent to the European Parliament, to the Council and to the Commission by 31 January; (d) to prepare each year the annual activity report on the Agency's activities and submit it to the management board; (e) to draw up a draft statement of estimates of the revenues and expenditure of the Agency as part of the single programming document pursuant to Article 115(3), and implement the budget pursuant to Article 116(1); (f) to delegate his or her powers to other statutory staff members subject to rules to be adopted in accordance with point (o) of Article 100(2); (g) to adopt a recommendation on measures in accordance with Article 32(7), including decisions proposing that Member States initiate and carry out joint operations, rapid border interventions or other actions referred to in Article 36(2); (h) to evaluate, approve and coordinate proposals made by Member States for joint operations or rapid border interventions in accordance with Article 37(3); (i) to evaluate, approve and coordinate requests made by Member States for return operations and return interventions in accordance with Articles 50 and 53; (j) to ensure the implementation of the operational plans referred to in Article 38, Article 42 and Article 53(3); (k) to ensure the implementation of the Council decision referred to in Article 42(1); (l) to withdraw financing of activities in accordance with Article 46; (m) to assess, prior to any operational activity of the Agency, whether there are violations of fundamental rights or international protection obligations that are of a serious nature or are likely to persist in accordance with Article 46(4) and (5); (n) to evaluate the results of activities in accordance with Article 47; (o) to identify the minimum number of items of technical equipment required to meet the Agency's needs, in particular as regards carrying out joint operations, migration management support team deployments, rapid border interventions, return operations and return interventions, in accordance with Article 64(6); (p) to propose the establishment of antenna offices or the prolongation of the duration of their operation in accordance with Article 60(5); (q) to appoint the heads of the antenna offices in accordance with Article 60(4); (r) to prepare an action plan following up on the conclusions of internal or external audit reports and evaluations, as well as on investigations by OLAF, and to report on progress to the Commission twice a year and to the management board on a regular basis; (s) to protect the financial interests of the Union by applying preventive measures against fraud, corruption and any other illegal activities by means of effective checks and, if irregularities are detected, by recovering amounts that were wrongly paid and, where appropriate, imposing effective, proportionate and dissuasive administrative and financial penalties; (t) to prepare an anti-fraud strategy for the Agency and present it to the management board for approval. 5. The executive director shall be accountable for his or her activities to the management board. 6. The executive director shall be the legal representative of the Agency. Article 107 Appointment of the executive director and the deputy executive directors 1. The Commission shall propose at least three candidates for the post of executive director and for the posts of each of the deputy executive directors on the basis of a list, following the publication of the post in the Official Journal of the European Union and, as appropriate, other press or internet sites. 2. On the basis of a proposal from the Commission, as provided for in paragraph 1, the management board shall appoint the executive director on the grounds of merit and documented high-level administrative and management skills, including relevant senior professional experience in the field of management of the external borders and return. Before appointment, the candidates proposed by the Commission shall be invited to make a statement before the competent committee or committees of the European Parliament and answer questions put by its or their members. Following such statements, the European Parliament shall adopt an opinion setting out its views and may indicate a preferred candidate. The management board shall appoint the executive director taking those views into account. The management board shall take its decision by a majority of two thirds of the members with a right to vote. If the management board takes a decision to appoint a candidate other than the candidate whom the European Parliament indicated as its preferred candidate, the management board shall inform the European Parliament and the Council in writing of the manner in which the opinion of the European Parliament was taken into account. The power to dismiss the executive director shall lie with the management board, acting on a proposal from the Commission. 3. The executive director shall be assisted by three deputy executive directors. Each deputy executive director shall be assigned a specific area of responsibility. If the executive director is absent or indisposed, one of the deputy executive directors shall take his or her place. 4. On the basis of a proposal from the Commission, as provided for in paragraph 1, the management board shall appoint the deputy executive directors on the grounds of merit and appropriate administrative and management skills, including relevant professional experience in the field of management of the external borders and return. The executive director shall be involved in the selection process. The management board shall take its decision by a majority of two thirds of the members with a right to vote. The management board shall have the power to dismiss the deputy executive directors in accordance with the procedure set out in the first subparagraph. 5. The term of office of the executive director shall be five years. By the end of that period, the Commission shall undertake an assessment that takes into account an evaluation of the executive director's performance and the Agency's future tasks and challenges. 6. The management board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 5, may extend the term of office of the executive director once for another period of up to five years. 7. The term of office of the deputy executive directors shall be five years. The management board, acting on a proposal from the Commission, may extend that term once for another period of up to five years. 8. The executive director and the deputy executive directors shall be engaged as temporary agents of the Agency under point (a) of Article 2 of the Conditions of Employment. Article 108 Consultative forum 1. A consultative forum shall be established by the Agency to assist it by providing independent advice in fundamental rights matters. The executive director and the management board, in coordination with the fundamental rights officer, may consult the consultative forum on any matter related to fundamental rights. 2. The Agency shall invite EASO, FRA, the United Nations High Commissioner for Refugees and other relevant organisations to participate in the consultative forum. On the basis of a proposal from the fundamental rights officer that was made after consulting the executive director, the management board shall decide on the composition of the consultative forum and the terms of the transmission of information to the consultative forum. The consultative forum shall, after consulting the management board and the executive director, define its working methods and set up its work programme. 3. The consultative forum shall be consulted on the further development and implementation of the fundamental rights strategy, on the functioning of the complaints mechanism, on codes of conduct and on the common core curricula. The Agency shall inform the consultative forum of the follow-up to its recommendations. 4. The consultative forum shall prepare an annual report of its activities. That report shall be made publicly available. 5. Without prejudice to the tasks of the fundamental rights officer, the consultative forum shall be provided with effective access in a timely and effective manner to all information concerning the respect for fundamental rights, including by carrying out on-the-spot visits to joint operations or rapid border interventions subject to the agreement of the host Member State or the third country, as applicable, to hotspot areas and to return operations and return interventions, including in third countries. Where the host Member State does not agree to an on-the-spot visit by the consultative forum to a joint operation or to a rapid border intervention carried out on its territory, it shall provide the Agency with duly justified reasons in writing. Article 109 Fundamental rights officer 1. A fundamental rights officer shall be appointed by the management board on the basis of a list of three candidates, after consultation with the consultative forum. The fundamental rights officer shall have the necessary qualifications, expert knowledge and professional experience in the field of fundamental rights. 2. The fundamental rights officer shall perform the following tasks: (a) contributing to the Agency's fundamental rights strategy and the corresponding action plan, including by issuing recommendations for improving them; (b) monitoring the Agency's compliance with fundamental rights, including by conducting investigations into any of its activities; (c) promoting the Agency's respect of fundamental rights; (d) advising the Agency where he or she deems it necessary or where requested on any activity of the Agency without delaying those activities; (e) providing opinions on the operational plans drawn up for the operational activities of the Agency, on pilot projects and on technical assistance projects in third countries; (f) providing opinions on working arrangements; (g) carrying out on-the-spot visits to any joint operation, rapid border intervention, pilot project, migration management support team deployment, return operation or return intervention, including in third countries; (h) providing the secretariat of the consultative forum; (i) informing the executive director about possible violations of fundamental rights during activities of the Agency; (j) selecting and managing the fundamental rights monitors; (k) performing any other tasks, where provided for by this Regulation. The secretariat referred to in point (h) of the first subparagraph shall receive instructions directly from the consultative forum. 3. For the purposes of point (j) of the first subparagraph of paragraph 2, the fundamental rights officer shall, in particular: (a) appoint the fundamental rights monitors; (b) assign fundamental rights monitors to operations and activities as provided for in Article 110(3); (c) nominate fundamental rights monitors as forced-return monitors for the pool referred to in Article 51; (d) ensure that fundamental rights monitors are adequately trained; (e) report to the executive director on possible violations of fundamental rights reported to him or her by the fundamental rights monitors as the fundamental rights officer deems necessary; The executive director shall reply to the fundamental rights officer as to how concerns regarding possible violations of fundamental rights as referred to in point (e) of the first subparagraph have been addressed. The fundamental rights officer may entrust any of the tasks provided for in points (a) to (i) and (k) of the first subparagraph of paragraph 2 to one of the fundamental rights monitors. 4. The management board shall lay down special rules applicable to the fundamental rights officer in order to guarantee that the fundamental rights officer and his or her staff are independent in the performance of their duties. The fundamental rights officer shall report directly to the management board and shall cooperate with the consultative forum. The management board shall ensure that action is taken with regard to recommendations of the fundamental rights officer. In addition, the fundamental rights officer shall publish annual reports on his or her activities and on the extent to which the activities of the Agency respect fundamental rights. Those reports shall include information on the complaints mechanism and the implementation of the fundamental rights strategy. 5. The Agency shall ensure that the fundamental rights officer is able to act autonomously and is able to be independent in the conduct of his or her duties. The fundamental rights officer shall have sufficient and adequate human and financial resources at his or her disposal necessary for the fulfilment of his or her tasks. The fundamental rights officer shall select his or her staff, and that staff shall only report to him or her. 6. The fundamental rights officer shall be assisted by a deputy fundamental rights officer. The deputy fundamental rights officer shall be appointed by the management board from a list of at least three candidates presented by the fundamental rights officer. The deputy fundamental rights officer shall have the necessary qualifications and experience in the field of fundamental rights and shall be independent in the conduct of his or her duties. If the fundamental rights officer is absent or indisposed, the deputy fundamental rights officer shall assume the fundamental rights officer's duties and responsibilities. 7. The fundamental rights officer shall have access to all information concerning respect for fundamental rights in all the activities of the Agency. Article 110 Fundamental rights monitors 1. Fundamental rights monitors, employed as statutory staff, shall constantly assess the fundamental rights compliance of operational activities, provide advice and assistance in that regard and contribute to the promotion of fundamental rights as part of European integrated border management. 2. Fundamental rights monitors shall have the following tasks: (a) monitoring compliance with fundamental rights and providing advice and assistance on fundamental rights in the preparation, conduct and evaluation of the operational activities of the Agency which the fundamental rights officer has assigned to them to monitor; (b) acting as forced-return monitors; (c) contributing to the training activities of the Agency on fundamental rights as provided for in Article 62, including by providing training on fundamental rights. For the purposes of point (a) of the first subparagraph, fundamental rights monitors shall, in particular: (a) follow the preparation of operational plans and report to the fundamental rights officer to enable him or her to fulfil his or her tasks as provided for in point(e) of Article 109(2); (b) conduct visits, including long-term visits, where operational activities take place; (c) cooperate and liaise with the coordinating officer as provided for in Article 44 and provide advice and assistance to him or her; (d) inform the coordinating officer and report to the fundamental rights officer on any concerns related to possible violation of fundamental rights within the Agency's operational activities; and (e) contribute to the evaluation of activities as referred to in Article 47. 3. Without prejudice to paragraph 4, the fundamental rights officer shall assign at least one fundamental rights monitor to each operation. The fundamental rights officer may also decide to assign fundamental rights monitors to monitor any other operational activity he or she considers relevant. Fundamental rights monitors shall have access to all areas in which the operational activity of the Agency takes place and to all its documents relevant for the implementation of that activity. 4. Fundamental rights monitors may be nominated by the fundamental rights officer as forced-return monitors for the pool referred to in Article 51. Where fundamental rights monitors act as forced-return monitors, Article 50(5) and Article 51 shall apply, mutatis mutandis. 5. The fundamental rights officer shall appoint the fundamental rights monitors and they shall be under his or her hierarchical supervision. Fundamental rights monitors shall be independent in the performance of their duties. When present in an operational area, fundamental rights monitors shall wear insignia that clearly allow for their identification as fundamental rights monitors. 6. The Agency shall ensure that by 5 December 2020 at least 40 fundamental rights monitors are recruited by the Agency. The executive director shall assess on an annual basis whether the number of fundamental rights monitors needs to be increased in consultation with the fundamental rights officer. Following that assessment, the executive director shall, where necessary, propose an increase in the number of fundamental rights monitors to the management board for the following year depending on operational needs. 7. Following their recruitment, fundamental rights monitors shall undergo enhanced fundamental rights training, taking into account previously acquired qualifications and professional experience in the relevant areas. Throughout their employment, the Agency shall ensure that fundamental rights monitors discharge their duties in accordance with the highest standards. Adequate training maps shall be designed for each fundamental rights monitor to ensure their continuous professional development to enable them to fulfil their role as fundamental rights monitors. Article 111 Complaints mechanism 1. The Agency shall, in cooperation with the fundamental rights officer, take the necessary measures to set up and further develop an independent and effective complaints mechanism in accordance with this Article to monitor and ensure respect for fundamental rights in all the activities of the Agency. 2. Any person who is directly affected by the actions or failure to act on the part of staff involved in a joint operation, pilot project, rapid border intervention, migration management support team deployment, return operation, return intervention or an operational activity of the Agency in a third country, and who considers himself or herself to have been the subject of a breach of his or her fundamental rights due to those actions or that failure to act, or any party representing such a person, may submit a complaint in writing to the Agency. 3. Only complaints that are substantiated and involve concrete fundamental rights violations shall be admissible. 4. The fundamental rights officer shall be responsible for handling complaints received by the Agency in accordance with the right to good administration. For that purpose, the fundamental rights officer shall review the admissibility of a complaint, register admissible complaints, forward all registered complaints to the executive director and forward complaints concerning members of the teams to the home Member State, including the relevant authority or body competent for fundamental rights in a Member State for further action in accordance with their mandate. The fundamental rights officer shall also register and ensure the follow-up by the Agency or that Member State. 5. In accordance with the right to good administration, if a complaint is admissible, complainants shall be informed that the complaint has been registered, that an assessment has been initiated and that a response may be expected as soon as it becomes available. If a complaint is forwarded to national authorities or bodies, the complainant shall be provided with their contact details. If a complaint is declared inadmissible, the complainant shall be informed of the reasons and, if possible, provided with further options for addressing their concerns. The Agency shall provide for an appropriate procedure in cases where a complaint is declared inadmissible or unfounded. Any decision shall be in written form and reasoned. The fundamental rights officer shall reassess the complaint if the complainant submits new evidence in situations where the complaint has been declared inadmissible or unfounded. 6. In the case of a registered complaint concerning a staff member of the Agency, the fundamental rights officer shall recommend appropriate follow-up, including disciplinary measures, to the executive director and, where appropriate, referral for the initiation of civil or criminal justice proceedings in accordance with this Regulation and national law. The executive director shall ensure the appropriate follow-up and shall report back to the fundamental rights officer within a determined timeframe and, if necessary, at regular intervals thereafter, as to the findings, the implementation of disciplinary measures, and follow-up by the Agency in response to a complaint. If a complaint is related to data protection issues, the executive director shall consult the data protection officer of the Agency before taking a decision on the complaint. The fundamental rights officer and the data protection officer shall establish, in writing, a memorandum of understanding specifying their division of tasks and cooperation as regards complaints received. 7. In the case of a registered complaint concerning a member of the teams from a host Member State or from another participating Member State, including a seconded member of the teams or seconded national expert, the home Member State shall ensure appropriate follow-up, including disciplinary measures, referral for the initiation of civil or criminal justice proceedings as necessary, and other measures in accordance with national law. The relevant Member State shall report back to the fundamental rights officer within a determined time period as to the findings and follow-up to the complaint, and, if necessary, at regular intervals thereafter. The Agency shall follow up on the matter if no report is received from the relevant Member State. Where the relevant Member State, within the determined time period, does not report back or provides only an inconclusive response, the fundamental rights officer shall inform the executive director and the management board. 8. Where a member of the teams is found to have violated fundamental rights or international protection obligations, the Agency shall request that the Member State remove that member immediately from the activity of the Agency or the standing corps. 9. The fundamental rights officer shall include information on the complaints mechanism in his or her annual report, as referred to in Article 109(4), including specific references to the Agency's and Member States' findings and the follow-up to complaints. 10. The fundamental rights officer shall, in accordance with paragraphs 1 to 9 and after consulting the consultative forum, draw up a standardised complaint form requiring detailed and specific information concerning the alleged breach of fundamental rights. The fundamental rights officer shall also draw up any further detailed rules as necessary. The fundamental rights officer shall submit that form and such further detailed rules to the executive director and to the management board. The Agency shall ensure that information about the possibility and procedure for making a complaint is readily available, including for vulnerable persons. The standardised complaint form shall be made available on the Agency's website and in hardcopy during all activities of the Agency in languages that third-country nationals understand or are reasonably believed to understand. The standardised complaint form shall be easily accessible, including on mobile devices. The Agency shall ensure that further guidance and assistance on the complaints procedure is provided to complainants. Complaints shall be considered by the fundamental rights officer even when they have not been submitted in the standardised complaint form. 11. Any personal data contained in a complaint shall be handled and processed by the Agency, including the fundamental rights officer, in accordance with Regulation (EU) 2018/1725 and by Member States in accordance with Regulation (EU) 2016/679 and Directive (EU) 2016/680. Where a complainant submits a complaint, that complainant shall be understood to consent to the processing of his or her personal data by the Agency and the fundamental rights officer within the meaning of point (d) of Article 5(1) of Regulation (EU) 2018/1725. In order to safeguard the interests of the complainants, complaints shall be dealt with confidentially by the fundamental rights officer in accordance with national and Union law unless the complainant explicitly waives his or her right to confidentiality. When complainants waive their right to confidentiality, it shall be understood that they consent to the fundamental rights officer or the Agency disclosing their identity to the competent authorities or bodies in relation to the matter under complaint, where necessary. Article 112 Interparliamentary cooperation 1. In order to address the specific nature of the European Border and Coast Guard, in that it is composed of national authorities and the Agency, and to ensure that the scrutiny functions of the European Parliament over the Agency and of the national parliaments over their respective national authorities are effectively exercised, as provided for in the Treaties and by national law respectively, the European Parliament and the national parliaments may cooperate in the framework of Article 9 of Protocol No 1 on the Role of National Parliaments in the European Union annexed to the TEU and to the TFEU. 2. When invited by the European Parliament and the national parliaments meeting within the context of paragraph 1, the executive director and the chairperson of the management board shall attend such meetings. 3. The Agency shall transmit its annual activity report to the national parliaments. Article 113 Language arrangements 1. Regulation No 1 (46) shall apply to the Agency. 2. Without prejudice to decisions taken on the basis of Article 342 TFEU, the annual activity report and the work programme shall be produced in all official languages of the Union. 3. The translation services required for the functioning of the Agency shall be provided by the Translation Centre for the Bodies of the European Union. Article 114 Transparency and communication 1. The Agency shall be subject to Regulation (EC) No 1049/2001 when handling applications for access to documents held by it. 2. The Agency shall communicate on matters falling within the scope of its tasks on its own initiative. It shall make public relevant information, including the annual activity report, the annual work programme, the code of conduct, strategic risk analyses, and comprehensive information on past and current joint operations, rapid border interventions, pilot projects, technical assistance projects with third countries, migration management support team deployments, return operations or return interventions, including in third countries, and working arrangements, and shall ensure, without prejudice to Article 92, in particular that the public and any interested party are rapidly given objective, detailed, comprehensive, reliable and easily understandable information with regard to its work. It shall do so without revealing operational information which, if made public, would jeopardise attainment of the objectives of operations. 3. The management board shall lay down the practical arrangements for the application of paragraphs 1 and 2. 4. Any natural or legal person shall be entitled to address written correspondence to the Agency in any of the official languages of the Union. He or she shall have the right to receive an answer in the same language. 5. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may give rise to a complaint being lodged with the European Ombudsman or to an action before the Court of Justice, under the conditions laid down in Articles 228 and 263 TFEU respectively. SECTION 4 Financial requirements Article 115 Budget 1. The revenue of the Agency shall consist, without prejudice to other types of income, of: (a) a contribution from the Union entered in the general budget of the European Union (Commission section); (b) a contribution from the countries associated with the implementation, application and development of the Schengen acquis, as established in the respective arrangements that specify their financial contribution; (c) Union funding in the form of contribution agreements or ad-hoc grants in accordance with the Agency's financial rules referred to in Article 120 and with the provisions of the relevant instruments supporting the policies of the Union; (d) fees for services provided; (e) any voluntary contribution from the Member States. 2. The expenditure of the Agency shall include its administrative, infrastructure, operational and staff-related expenses. 3. The executive director shall draw up a draft statement of estimates of the Agency's revenue and expenditure for the following financial year, including an establishment plan, and shall forward it to the management board. 4. Revenue and expenditure shall be balanced. 5. The management board shall, on the basis of the draft statement of estimates drawn up by the executive director, adopt a provisional draft estimate of the Agency's revenue and expenditure, including the provisional establishment plan. The management board shall forward them to the European Parliament, to the Council and to the Commission by 31 January every year, as part of the draft single programming document. 6. The management board shall send the final draft estimates of the Agency's revenue and expenditure including the draft establishment plan accompanied by the preliminary work programme to the Commission by 31 March every year. 7. The estimate shall be forwarded by the Commission to the budgetary authority together with the draft general budget of the European Union. 8. On the basis of the estimate, the Commission shall enter in the draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the contribution to be charged to the general budget, which it shall place before the budgetary authority in accordance with Articles 313 and 314 TFEU. 9. The budgetary authority shall authorise appropriations for the contribution to the Agency. 10. The budgetary authority shall adopt the establishment plan for the Agency. 11. The management board shall adopt the Agency's budget. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly. 12. Any modification to the budget, including the establishment plan, shall follow the same procedure. 13. For any building project likely to have significant implications for the budget of the Agency, the provisions of Commission Delegated Regulation (EU) 2019/715 (47) shall apply. 14. To finance the deployment of rapid border interventions and return interventions, the budget of the Agency adopted by the management board shall include a financial operational reserve amounting to at least 2 % of the allocation provided jointly for joint operations at the external borders and operational activities in the area of return. After the end of each month, the executive director may decide to reallocate a sum equivalent to one twelfth of the appropriations of the reserve to other operational activities of the Agency. In such a case, the executive director shall inform the management board. 15. Budgetary commitments for actions extending over more than one financial year may be broken down over several years into annual instalments. Article 116 Implementation and control of the budget 1. The executive director shall implement the Agency's budget. 2. By 1 March of a financial year N + 1, the Agency's accounting officer shall communicate the provisional accounts for the financial year N to the Commission's accounting officer and to the Court of Auditors. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 245 of Regulation (EU, Euratom) 2018/1046. 3. The Agency shall send a report on the budgetary and financial management for year N to the European Parliament, to the Council and to the Court of Auditors by 31 March of year N + 1. 4. The Commission's accounting officer shall send the Agency's provisional accounts for year N, consolidated with the Commission's accounts, to the Court of Auditors by 31 March of year N + 1. 5. On receipt of the Court of Auditors' observations on the Agency's provisional accounts for year N, pursuant to Article 246 of Regulation (EU, Euratom) 2018/1046, the executive director shall draw up the Agency's final accounts under his or her own responsibility and forward them to the management board for an opinion. 6. The management board shall deliver an opinion on the Agency's final accounts for year N. 7. By 1 July of year N + 1, the executive director shall send the final accounts, together with the opinion of the management board, to the European Parliament, to the Council, to the Commission and to the Court of Auditors. 8. The final accounts for year N shall be published in the Official Journal of the European Union by 15 November of year N + 1. 9. The executive director shall send the Court of Auditors a reply to its observations by 30 September of year N + 1. He or she shall also send this reply to the management board. 10. The executive director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for year N, in accordance with Article 261(3) of Regulation (EU, Euratom) 2018/1046. 11. On a recommendation from the Council acting by qualified majority, the European Parliament shall, before 15 May of the year N + 2, give a discharge to the executive director in respect of the implementation of the budget for the year N. Article 117 Combating fraud 1. In order to combat fraud, corruption and other illegal activities, the provisions of Regulation (EU, Euratom) No 883/2013 shall apply without restriction. The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by the European Anti-Fraud Office (OLAF) and shall adopt, without delay, the appropriate provisions applicable to all staff of the Agency using the template set out in the Annex to that Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds from the Agency. 3. OLAF may carry out administrative investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96 (48) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded by the Agency. 4. In accordance with Regulation (EU) 2017/1939, the European Public Prosecutor's Office (EPPO) may investigate and prosecute fraud and other illegal activities affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371. 5. Without prejudice to paragraphs 1 to 4, working arrangements with third countries and with international organisations, grant agreements, grant decisions and contracts of the Agency shall contain provisions expressly empowering the Court of Auditors, OLAF and EPPO to conduct such audits and investigations, in accordance with their respective competences. Article 118 Prevention of conflicts of interest The Agency shall adopt internal rules requiring the members of its bodies and its staff to avoid any situation liable to give rise to a conflict of interest during their employment or term of office and to report such situations. The Agency shall ensure that there is transparency as regards lobbying by means of a transparency register and by disclosing all its meetings with third-party stakeholders. The transparency register shall include all meetings and contacts between third-party stakeholders and the executive director, deputy executive directors and heads of division in matters concerning procurements and tenders for services, equipment or outsourced projects and studies. The Agency shall keep a record of all meetings of its staff with third-party stakeholders in matters concerning procurements and tenders for services, equipment or outsourced projects and studies. Article 119 Administrative inquiries The activities of the Agency shall be subject to the inquiries of the European Ombudsman in accordance with Article 228 TFEU. Article 120 Financial provision The financial rules applicable to the Agency shall be adopted by the management board after consulting the Commission. They shall not depart from Delegated Regulation (EU) No 1271/2013 unless such a departure is specifically required for the Agency's operation and the Commission has given its prior consent. In this framework, the management board shall adopt specific financial rules applicable to the Agency's activities in the area of cooperation with third countries in the field of return. Article 121 Evaluation 1. Without prejudice to Article 59, by 5 December 2023, and every four years thereafter, the Commission shall carry out an evaluation of this Regulation. The evaluation shall assess in particular: (a) the results achieved by the Agency, having regard to its objectives, mandate, resources and tasks; (b) the impact, effectiveness and efficiency of the Agency's performance and its working practices in relation to its objectives, mandate and tasks; (c) inter-agency cooperation at the European level, including the implementation of European cooperation on coast guard functions; (d) the possible need to modify the mandate of the Agency; (e) the financial implications of any such modification; (f) the functioning of the standing corps and, as from the second evaluation, its overall number and composition; (g) the level of training, specialised expertise and professionalism of the standing corps. The evaluation shall include a specific analysis on the way the Charter and other relevant Union law has been complied with in the application of this Regulation. 2. The evaluation shall also assess the attractiveness of the Agency as an employer for the recruitment of statutory staff, with a view of ensuring quality of the candidates and geographical balance. 3. When carrying out the evaluation, the Commission shall seek input from relevant stakeholders, including the consultative forum and FRA. 4. The Commission shall send the evaluation reports together with its conclusions on the reports to the European Parliament, to the Council and to the management board. The management board may issue recommendations regarding changes to this Regulation to the Commission. The evaluation reports and the conclusions on the reports shall be made public. The Member States and the Agency shall provide the Commission with the information necessary to draft the evaluation reports. Where necessary, the evaluation reports shall be accompanied by legislative proposals. 5. The Agency shall submit a report to the European Parliament and to the Council on the functioning of EUROSUR by 1 December 2021 and every two years thereafter. Member States shall provide the Agency with the information necessary to draft those reports. 6. As part of the evaluation referred to in paragraph 1, the Commission shall provide an overall evaluation of EUROSUR accompanied, where necessary, by appropriate proposals to improve its functioning. The Member States and the Agency shall provide the Commission with the information necessary to produce the overall evaluation referred to in the first subparagraph. When carrying out the overall evaluation referred to in the first subparagraph, the Commission shall seek input from relevant stakeholders, including the consultative forum and FRA. CHAPTER V FINAL PROVISIONS Article 122 Committee procedure 1. The Commission shall be assisted by a committee (\u2018the European Board and Coast Guard Committee\u2019). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 123 Repeal and transitional provisions 1. Regulation (EU) No 1052/2013 is repealed with the exception of Article 9(3), (5), (7) to (10) and Article 10(5) and (7) thereof, which are repealed with effect from the date of the entry into force of the implementing act referred to in Article 24(3) of this Regulation. 2. Regulation (EU) 2016/1624 is repealed with the exception of Articles 20, 30 and 31 thereof, which are repealed with effect from 1 January 2021. 3. Deployments in accordance with Article 54 to 58 shall take place as of 1 January 2021. 4. For the deployments in 2021, the management board shall adopt the decisions referred to Article 54(4) and Article 64(6) by 31 March 2020. 5. For the purpose of supporting the development of human resources to secure the contributions of the Member States to the standing corps, Member States shall be entitled to receive funding in 2020 in accordance with point (a) of Article 61(1). The numbers in Annex II for 2022 shall be used as a reference for the relevant funding in 2020. 6. In order to effectively contribute the required numbers of statutory staff to the first deployments of the standing corps and the setting up of the ETIAS Central Unit, the Agency shall launch the necessary preparations, including recruitment and training, as of 4 December 2019 and in accordance with the budgetary rules. 7. Until 5 December 2021, Member States may provide information to EUROSUR on border checks and air border surveillance on a voluntary basis. 8. References to the repealed acts shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI to this Regulation. Article 124 Entry into force and applicability 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. Article 79 shall apply from the date of the effective transfer of the system referred to in that Article. 3. Article 12(3), Article 70 and Article 100(5), insofar as they concern the cooperation with the United Kingdom, shall apply until the day on which the Treaties cease to apply to the United Kingdom pursuant to Article 50(3) TEU or, provided that a withdrawal agreement concluded with the United Kingdom in accordance with Article 50(2) TEU has entered into force by that date, until the end of the transition period set in that withdrawal agreement. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 13 November 2019. For the European Parliament The President D. M. SASSOLI For the Council The President T. TUPPURAINEN (1) OJ C 110, 22.3.2019, p. 62. (2) OJ C 168, 16.5.2019, p. 74. (3) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and decision of the Council of 8 November 2019. (4) Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 349, 25.11.2004, p. 1). (5) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1). (6) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). (7) Regulation (EU) No 656/2014 of the European Parliament and of the Council of 15 May 2014 establishing rules for the surveillance of the external sea borders in the context of operational cooperation coordinated by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 189, 27.6.2014, p. 93). (8) Regulation (EU) No 1052/2013 of the European Parliament and of the Council of 22 October 2013 establishing the European Border Surveillance System (Eurosur) (OJ L 295, 6.11.2013, p. 11). (9) Council Directive 2002/90/EC of 28 November 2002 defining the facilitation of unauthorised entry, transit and residence (OJ L 328, 5.12.2002, p. 17). (10) Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, p. 27). (11) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (12) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (13) Joint Action 98/700/JHA of 3 December 1998 adopted by the Council on the basis of Article K.3 of the Treaty on European Union concerning the setting up of a European Image Archiving System (FADO) (OJ L 333, 9.12.1998, p. 4). (14) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (15) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (16) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (17) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (18) OJ L 136, 31.5.1999, p. 15. (19) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor's Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (20) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (21) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (22) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (23) OJ L 176, 10.7.1999, p. 36. (24) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (25) OJ L 188, 20.7.2007, p. 19. (26) OJ L 53, 27.2.2008, p. 52. (27) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (28) OJ L 160, 18.6.2011, p. 21. (29) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (30) OJ L 243, 16.9.2010, p. 4. (31) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (32) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (33) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (34) OJ L 56, 4.3.1968, p. 1. (35) Regulation (EU) 2019/1240 of the European Parliament and of the Council of 20 June 2019 on the creation of a European network of immigration liaison officers (OJ L 198, 25.7.2019, p. 88). (36) Council Decision 2008/381/EC of 14 May 2008 establishing a European Migration Network (OJ L 131, 21.5.2008, p. 7). (37) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1). (38) Regulation (EU) No 1285/2013 of the European Parliament and of the Council of 11 December 2013 on the implementation and exploitation of European satellite navigation systems and repealing Council Regulation (EC) No 876/2002 and Regulation (EC) No 683/2008 of the European Parliament and of the Council (OJ L 347, 20.12.2013, p. 1). (39) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1). (40) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1). (41) Regulation (EU) No 603/2013 of the European Parliament and of the Council of 26 June 2013 on the establishment of \u2018Eurodac\u2019 for the comparison of fingerprints for the effective application of Regulation (EU) No 604/2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes, and amending Regulation (EU) No 1077/2011 establishing a European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice (OJ L 180, 29.6.2013, p. 1). (42) Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (OJ L 150, 20.5.2014, p. 143). (43) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60). (44) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). (45) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (46) Regulation No 1 of 15 April 1958 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). (47) Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1). (48) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). ANNEX I Capacity of the standing corps per year and category in accordance with Article 54 Category/Year Category 1 Statutory staff Category 2 Operational staff for long-term secondments Category 3 Operational staff for short-term deployments Category 4 Reserve for rapid reaction Total for the standing corps 2021 1 000 400 3 600 1 500 6 500 2022 1 000 500 3 500 1 500 6 500 2023 1 500 500 4 000 1 500 7 500 2024 1 500 750 4 250 1 500 8 000 2025 2 000 1 000 5 000 0 8 000 2026 2 500 1 250 5 250 0 9 000 2027 and beyond 3 000 1 500 5 500 0 10 000 ANNEX II Annual contributions to be provided by Member States to the standing corps through the long-term secondment of staff in accordance with Article 56 Country/Year 2021 2022 2023 2024 2025 2026 2027 and beyond Belgium 8 10 10 15 20 25 30 Bulgaria 11 13 13 20 27 33 40 Czech Republic 5 7 7 10 13 17 20 Denmark 8 10 10 15 19 24 29 Germany 61 73 73 110 152 187 225 Estonia 5 6 6 9 12 15 18 Greece 13 17 17 25 33 42 50 Spain 30 37 37 56 74 93 111 France 46 56 56 83 114 141 170 Croatia 17 22 22 33 43 54 65 Italy 33 42 42 63 83 104 125 Cyprus 2 3 3 4 5 7 8 Latvia 8 10 10 15 20 25 30 Lithuania 10 13 13 20 26 33 39 Luxembourg 2 3 3 4 5 7 8 Hungary 17 22 22 33 43 54 65 Malta 2 2 2 3 4 5 6 Netherlands 13 17 17 25 33 42 50 Austria 9 11 11 17 23 28 34 Poland 27 33 33 50 67 83 100 Portugal 8 10 10 15 20 25 30 Romania 20 25 25 38 50 63 75 Slovenia 9 12 12 18 23 29 35 Slovakia 9 12 12 18 23 29 35 Finland 8 10 10 15 20 25 30 Sweden 9 11 11 17 23 28 34 Switzerland 4 5 5 8 11 13 16 Iceland 1 1 1 1 1 2 2 Liechtenstein (*1) 0 0 0 0 0 0 0 Norway 5 7 7 10 13 17 20 TOTAL 400 500 500 750 1 000 1 250 1 500 (*1) Liechtenstein will contribute through proportional financial support. ANNEX III Annual contributions to be provided by Member States to the standing corps for short-term deployments of staff in accordance with Article 57 Country/Year 2021 2022 2023 2024 2025 2026 2027 and beyond Belgium 72 70 80 85 100 105 110 Bulgaria 96 93 107 113 133 140 147 Czech Republic 48 47 53 57 67 70 73 Denmark 70 68 77 82 97 102 106 Germany 540 523 602 637 748 785 827 Estonia 43 42 48 51 60 63 66 Greece 120 117 133 142 167 175 183 Spain 266 259 296 315 370 389 407 France 408 396 454 481 566 593 624 Croatia 156 152 173 184 217 228 238 Italy 300 292 333 354 417 438 458 Cyprus 19 19 21 23 27 28 29 Latvia 72 70 80 85 100 105 110 Lithuania 94 91 104 111 130 137 143 Luxembourg 19 19 21 23 27 28 29 Hungary 156 152 173 184 217 228 238 Malta 14 14 16 17 20 21 22 Netherlands 120 117 133 142 167 175 183 Austria 82 79 91 96 113 119 125 Poland 240 233 267 283 333 350 367 Portugal 72 0 80 85 100 105 110 Romania 180 175 200 213 250 263 275 Slovenia 84 82 93 99 117 123 128 Slovakia 84 82 93 99 117 123 128 Finland 72 70 80 85 100 105 110 Sweden 82 79 91 96 113 119 125 Switzerland 38 37 43 45 53 56 59 Iceland 5 5 5 6 7 7 7 Liechtenstein (*1) 0 0 0 0 0 0 0 Norway 48 47 53 57 67 70 73 TOTAL 3 600 3 500 4 000 4 250 5 000 5 250 5 500 (*1) Liechtenstein will contribute through proportional financial support. ANNEX IV Contributions to be provided by Member States to the standing corps through the reserve for rapid reaction in accordance with Article 58 Country Number Belgium 30 Bulgaria 40 Czech Republic 20 Denmark 29 Germany 225 Estonia 18 Greece 50 Spain 111 France 170 Croatia 65 Italy 125 Cyprus 8 Latvia 30 Lithuania 39 Luxembourg 8 Hungary 65 Malta 6 Netherlands 50 Austria 34 Poland 100 Portugal 30 Romania 75 Slovenia 35 Slovakia 35 Finland 30 Sweden 34 Switzerland 16 Iceland 2 Liechtenstein (*1) 0 Norway 20 TOTAL 1 500 (*1) Liechtenstein will contribute through proportional financial support. ANNEX V Rules on the use of force, including training and the supply, control and use of service weapons and non-lethal equipment, applicable to statutory staff deployed as members of the teams 1. General Principles Governing the Use of Force and Weapons For the purposes of this Regulation, \u2018use of force\u2019 refers to recourse by statutory staff deployed as members of the teams to physical means for the purposes of performing their functions or ensuring self-defence, which includes the use of hands and body and the use of any instruments, weapons, including firearms, or equipment. Weapons, ammunition and equipment shall only be carried and used during operations. Carrying or using weapons, ammunition and equipment during off duty periods shall be prohibited. In accordance with Article 82(8), the use of force and weapons by statutory staff deployed as members of the teams shall be exercised in accordance with the national law of the host Member State, in the presence of border guards of the host Member State. Without prejudice to the authorisation by the host Member State and the applicability of its national law to the use of force during operations, the use of force and weapons by statutory staff deployed as members of the teams shall comply with the principles of necessity, proportionality and precaution (the \u2018core principles\u2019) as set out below. The operational plan agreed between the executive director and the host Member State shall define the conditions for carrying and using weapons in accordance with national law or operating procedures during operations. The Principle of Necessity The use of force, whether through direct physical contact or by the use of weapons or equipment, shall be exceptional and shall only take place where it is strictly necessary to ensure the performance of the Agency\u2019s duties or in self-defence. Force shall only be used as a last resort, after every reasonable effort has been made to resolve a situation using non-violent means, including by means of persuasion, negotiation, or mediation. The use of force or coercive measures shall never be arbitrary or abusive. The Principle of Proportionality Whenever the lawful use of force or firearms is unavoidable, statutory staff deployed as members of the teams shall act in proportion to the seriousness of the situation and the legitimate objective to be achieved. During operational activities, the proportionality principle shall guide both the nature of the force used (e.g. the need for the use of weapons) as well as the extent of the force applied. Statutory staff deployed as members of the teams shall not use more force than is absolutely necessary to achieve the legitimate law enforcement objective. If a firearm is used, statutory staff deployed as members of the teams shall ensure that such use causes the least possible injury and minimises injury and damage to the greatest possible extent. Where the measures lead to an unacceptable result, statutory staff deployed as members of the teams may waive the measure. The principle of proportionality requires the Agency to provide equipment and self-defensive tools to statutory staff deployed as members of the teams which are necessary to enable the appropriate level of force to be applied. The Duty of Precaution Operational activities carried out statutory staff deployed as members of the teams shall fully respect and aim to preserve human life and human dignity. All necessary steps that can minimise the risk of injury and damage during operations shall be taken. This obligation includes a general obligation for statutory staff deployed as members of the teams to give clear warnings of their intention to use force, unless giving such a warning would unduly place the members of the teams at risk or would create a risk of death or serious harm to others, or would be clearly inappropriate or ineffective in the particular circumstances. 2. Specific rules for the most commonly used instruments of force (equipment of statutory staff deployed as members of the teams) In accordance with the core principles, the use of force shall only be permissible to the extent that the use of force is necessary for achieving the immediate law enforcement aim, and only after: \u2014 attempts to resolve a potentially violent confrontation by means of persuasion, negotiation, mediation have been exhausted and failed, \u2014 a warning of the intention to use force has been given. Where it is necessary to escalate the level of intervention (for example, using a weapon or a different kind of weapon), clear warning of such an escalation shall also be given unless giving such a warning would unduly place members of teams at risk or would create a risk of death or serious harm to others, or would be clearly inappropriate or ineffective in the particular circumstances. Firearms Statutory staff deployed as members of the teams shall not use firearms against persons, except in the following circumstances, and only when less extreme means are insufficient to achieve the necessary objectives: \u2014 the use of firearms by statutory staff deployed as members of the teams is a last resort in an extreme emergency, especially if there is any risk that bystanders might be endangered, \u2014 the use of firearms by statutory staff deployed as members of the teams is necessary to defend themselves or others against an imminent threat of death or serious injury, \u2014 the use of firearms by statutory staff deployed as members of the teams is to prevent an imminent threat of death or serious injury, \u2014 the use of firearms by statutory staff deployed as members of the teams is to repel an actual attack or prevent an impending dangerous attack on essential institutions, services or facilities. Prior to the use of firearms, statutory staff deployed as members of the teams must give a clear warning of their intention to use such firearms. Warnings may be given orally or by the firing of warning shots. Non-lethal weapons Baton Approved batons may be used as a means of defence or as a weapon, as appropriate, in line with the core principles, as follows: \u2014 when lesser use of force is considered clearly unsuitable for the purpose, \u2014 to avert an actual or impending attack on property. Prior to the use of batons, statutory staff deployed as members of the teams must give a clear warning of their intention to use batons. In using batons, statutory staff deployed as members of the teams shall always aim to minimise the risk of injury suffered and avoid contact with the head. Lachrymatory agents (e.g. pepper spray) Approved lachrymatory agents may be used as a means of defence or as a weapon, as appropriate, in line with the core principles, as follows: \u2014 when lesser use of force is considered clearly unsuitable for the purpose, \u2014 to avert an actual or impending attack. Other equipment Handcuffs Handcuffs shall only be placed on persons who are considered to present a danger to themselves or to others, in order to ensure their safe detention or transportation and to ensure the safety of statutory staff deployed as members of the teams and other members of the teams. Handcuffs shall only be used for the shortest time possible and only where strictly necessary. 3. Practical rules on the use of force, service weapons, ammunition and equipment during operations General practical rules on the use of force, weapons and other equipment during operations In accordance with Article 82(8), statutory staff deployed as members of the teams are to exercise their executive power, including the use of force, under the command and control of the host Member State, and shall only use force, including using weapons, ammunition and equipment, in the presence of the border guards of the host Member State following the authorisation of the competent authorities of the host Member State. Nevertheless, the competent authorities of the host Member State may authorise statutory staff deployed as members of the teams, with the consent of the Agency, to use force in the absence of officers of the host Member State. The host Member State may prohibit the carrying of certain service weapons, ammunition and equipment in accordance with the second subparagraph of Article 82(8). Without prejudice to the authorisation by the host Member State and the applicability of its national law to the use of force during operations, the use of force and weapons by statutory staff deployed as members of the teams shall: (a) comply with the core principles and specific rules referred to in Part 2; (b) respect fundamental rights as guaranteed under international and Union law, including, in particular, under the Charter, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the United Nations Basic Principles on the Use of Force and Firearms by Law Enforcement Officials, and the United Nations Code of Conduct for Law Enforcement Officials; (c) comply with the Agency\u2019s code of conduct. 4. Control Mechanism The Agency shall provide the following safeguards in relation to the use of force, weapons, ammunition and equipment, and shall provide a stocktaking in its annual report. Training The training provided in accordance with Article 62(2) shall cover theoretical and practical aspects in relation to the prevention of and use of force. The theoretical training shall incorporate psychological training, including training in resilience and working in situations of high pressure, as well as techniques for avoiding the use of force, such as negotiation and mediation. The theoretical training shall be followed by obligatory and adequate theoretical and practical training on the use of force, weapons, ammunition and equipment and on applicable fundamental rights safeguards. In order to ensure a common practical understanding and approach, the practical training shall end with a simulation relevant to the activities to be carried out during the deployment and shall include a practical simulation involving the operationalisation of fundamental rights safeguards. The Agency shall provide statutory staff deployed as members of the teams with annual ongoing training on the use of force. Such training shall take place as per the training provided for in Article 62(2). In order for statutory staff deployed as members of the teams to be permitted to carry service weapons and to use force, they shall be required to have successfully completed the annual ongoing training. The annual ongoing training shall cover theoretical and practical aspects as described in the first paragraph. The annual ongoing training shall last at least 24 hours in total, with the theoretical training taking at least 8 hours and the practical training taking at least 16 hours. The practical training shall be divided into at least 8 hours for physical training, using physical restraint techniques, and at least 8 hours for the use of firearms. Use of narcotics, drugs and alcohol consumption Statutory staff deployed as members of the teams shall not consume or be under the influence of alcohol while on duty. Statutory staff deployed as members of the teams shall not possess or use narcotics or drugs, unless prescribed on medical grounds. Statutory staff deployed as members of the teams requiring drugs for medical purposes shall immediately inform their immediate superior of such a requirement. Their participation in operational activities may be reviewed having regard to potential effects and side-effects associated with the use of the substance. The Agency shall establish a control mechanism to ensure that its statutory staff deployed as members of the teams do not carry out their functions under the influence of narcotics, drugs or alcohol. That mechanism shall be based on regular medical testing of statutory staff deployed as members of the teams in order to identify any possible consumption of narcotics, drugs or alcohol. Any positive test results shall be immediately reported to the executive director. Reporting Any incidents involving the use of force shall be immediately reported through the chain of command to the coordination structure relevant for each operation and to the fundamental rights officer and the executive director. The report shall provide full details of the circumstances in which such use arose. Duty to cooperate and inform Statutory staff deployed as members of the teams and any other participants in operations shall cooperate in the gathering of facts related to any incident which was reported during an operational activity. Supervisory mechanism The Agency shall establish a supervisory mechanism as referred to in point (a) of Article 55(5). Complaints mechanism Any person may report suspected breaches by statutory staff deployed as members of the teams of the rules on the use of force applicable under this Annex through the complaints mechanism provided for in Article 111. Sanctions Without prejudice to Article 85, where the Agency establishes that a member of its statutory staff deployed as a member of the teams has performed activities in breach of the rules applicable under this Regulation, including fundamental rights protected under the Charter, the European Convention for the Protection of Human Rights and Fundamental Freedoms and international law, the executive director shall take adequate measures, which may include the immediate recall of that statutory staff member from the operational activity, and any disciplinary measures in accordance with the Staff Regulations, including the removal of the statutory staff member from the Agency. Role of the fundamental rights officer The fundamental rights officer shall verify and provide feedback on the content of induction and refresher training paying special regard to aspects relating to fundamental rights and how fundamental rights can be protected in situations where the use of force is necessary, and ensure relevant preventive techniques are included. The fundamental rights officer shall report on the respect for fundamental rights within the law enforcement practices of the host Member State or host third country. That report shall be submitted to the executive director and shall be taken into account in the design of the operational plan. The fundamental rights officer shall ensure that incidents related to the use of force and use of weapons, ammunition and equipment are thoroughly investigated and reported without delay to the executive director. The results of such investigations shall be transmitted to the consultative forum. All activities related to the use of force, weapons, ammunition and equipment shall be regularly monitored by the fundamental rights officer, and all incidents shall be reported in the fundamental rights officer\u2019s reports as well in the annual report of the Agency. 5. Provision of service weapons Authorisation of weapons For the purposes of determining the exact service weapons, ammunition and other equipment to be used by statutory staff deployed as members of the teams, the Agency shall establish an exhaustive list of items to be included in personal equipment sets. Personal equipment sets shall be used by all statutory staff deployed as members of the teams. The Agency may also complement personal equipment sets with additional weapons, ammunition or other equipment specific for the purpose of carrying out specific tasks within one or two types of teams. The Agency shall ensure that all weapons, including firearms, ammunition and equipment provided to statutory staff deployed as members of the teams comply with all the necessary technical standards. Weapons, ammunition and equipment that are authorised for use shall be listed in the operational plan in line with the requirements on admissible and prohibited weapons of the host Member State. Instructions for duty period Weapons, ammunition and equipment may be carried during operations and shall be used only as measures of last resort. Carrying or using weapons, ammunition and equipment during off-duty periods shall not be allowed. The Agency shall establish specific rules and measures to facilitate the storage of weapons, ammunition and other equipment of statutory staff deployed as members of the teams during off-duty periods in secured facilities as referred to in point (c) of Article 55(5). ANNEX VI Correlation Table Regulation (EU) 2016/1624 Regulation (EU) No 1052/2013 This Regulation Article 1, first sentence \u2014 Article 1, first paragraph Article 1, second sentence \u2014 Article 1, second paragraph Article 2, point (1) \u2014 Article 2, point 1 \u2014 \u2014 Article 2, points (2), (4), (5), (6), (9)(15), (16), (17), (18), (29), and (30) Article 2, point (2) \u2014 Article 2, point (3) \u2014 Article 3, points (b), (c), (d), (f) and (g) Article 2, points (7), (8), (10), (11), and (13) Article 2, point (16) Article 3, point (e) Article 2, point (12) \u2014 Article 3, point (i) Article 2, point (14) Article 2, point (9) \u2014 Article 2, point (19) Article 2, points (5) to (7) \u2014 Article 2, points (20) to (22) Article 2, points (10) to (15) \u2014 Article 2, points (23) to (28) Article 4, points (a) to (d) \u2014 Article 3(1), points (a) to (d) Article 4, point (e) \u2014 Article 3(1), points (e) and (f) Article 4, points (f) to (k) \u2014 Article 3(1), points (g) to (l) \u2014 \u2014 Article 3(2) Article 3(1) \u2014 Article 4 Article 6 \u2014 Article 5 Article 7 \u2014 Article 6 Article 5(1) \u2014 Article 7(1) \u2014 \u2014 Article 7(2) Article 5(2) and (3) \u2014 Article 7(3) and (4) Article 8(2) \u2014 Article 7(5) \u2014 \u2014 Article 8(1) to (4) Article 3(2) \u2014 Article 8(5) Article 3(3) \u2014 Article 8(6) \u2014 \u2014 Article 8(7) and (8) \u2014 \u2014 Article 9 Article 8(1), point (a) \u2014 Article 10(1), point (a) \u2014 \u2014 Article 10(1), point (b) Article 8(1), point (b) \u2014 Article 10(1), point (c) Article 8(1), point (c) \u2014 Article 10(1), point (d) \u2014 \u2014 Article 10(1), point (e) Article 8(1), point (s) \u2014 Article 10(1), point (f) Article 8(1), point (d) \u2014 Article 10(1), point (g) Article 8(1), point (e) \u2014 Article 10(1), point (h) Article 8(1), point (f) \u2014 Article 10(1), point (i) Article 8(1), point (g) \u2014 Article 10(1), point (j) Article 8(1), point (h) \u2014 Article 10(1), point (k) \u2014 \u2014 Article 10(1), point (l) Article 8(1), point (i) \u2014 Article 10(1), point (m) Article 8(1), point (l) \u2014 Article 10(1), point (n) Article 8(1), point (n) \u2014 Article 10(1), point (o) Article 8(1), point (o) \u2014 Article 10(1), point (p) Article 8(1), point (m) \u2014 Article 10(1), point (q) \u2014 \u2014 Article 10(1), points (r) and (s) Article 8(1), point (t) \u2014 Article 10(1), point (t) \u2014 \u2014 Article 10(1), point (u) Article 8(1), point (u) \u2014 Article 10(1), point (v) Article 8(1), point (p) \u2014 Article 10(1), point (w) Article 8(1), point (q) \u2014 Article 10(1), point (x) \u2014 \u2014 Article 10(1), point (y) Article 8(1), point (j) \u2014 Article 10(1), point (z) \u2014 Article 6(1), point (a) Article 10(1), point (aa) Article 8(1), point (r) \u2014 Article 10(1), point (ab) Article 8(1), point (s) \u2014 Article 10(1), point (ac) \u2014 \u2014 Article 10(1), points (ad) to (ag) Article 8(3) \u2014 Article 10(2) Article 9 \u2014 Article 11 Article 10 \u2014 Article 12(1) \u2014 \u2014 Article 12(2) and (3) Article 23 \u2014 Article 13(1), (first sentence) \u2014 \u2014 Article 13(1), second sentence \u2014 \u2014 Article 13(2) and (3) \u2014 Article 7(1) Article 14(1) \u2014 Article 7(2) Article 14(2) Article 44(1) \u2014 Article 15(1) and (2) \u2014 \u2014 Article 15(3) \u2014 \u2014 Article 16 \u2014 \u2014 Article 17 \u2014 Article 1 Article 18 \u2014 Article 2(1) and (2) Article 19(1) \u2014 Article 2(3) Article 19(2) \u2014 Article 4(1), points (a) and (b) Article 20(1), points (a) and (b) \u2014 Article 4(1), point (d) Article 20(1), point (c) \u2014 \u2014 Article 20(1), points (d), (e) and (f) \u2014 Article 4(2) and (3) Article 20(2) and (3) \u2014 Article 5(1), (2) and (3) Article 21(1), (2) and (3), points (a) to (h) \u2014 \u2014 Article 21(3), points (i) and (j) \u2014 Article 17(1), (2), and (3) Article 21(4), (5), and (6) \u2014 Article 5(4) Article 21(7) \u2014 Article 21 Article 22 \u2014 Article 22(1) Article 23(1) \u2014 \u2014 Article 23(2) and (3) \u2014 Article 8(1) and (2) Article 24(1) \u2014 \u2014 Article 24(2) \u2014 \u2014 Article 24(3) \u2014 Article 9(1) Article 25(1) \u2014 Article 9(2), points (a) to (e) Article 25(2), points (a) to (e) \u2014 \u2014 Article 25(2), point (f) \u2014 Article 9(2), point (f) Article 25(2), point (g) \u2014 Article 9(2), point (g) Article 25(2), point (h) \u2014 Article 9(2), point (h) Article 25(2), point (i) \u2014 Article 9(2), point (i) Article 25(2), point (j) \u2014 Article 9(2), point (j) Article 25(2), point (k) \u2014 Article 9(2), point (k) Article 25(2), point (l) \u2014 Article 9(4) Article 25(3) \u2014 Article 9(5), point (a), second sentence Article 25(4) \u2014 Article 9(10) Article 25(5) \u2014 Article 10(1) Article 26(1) \u2014 Article 10(2), points (a) and (b) Article 26(2), points (a) and (b) \u2014 Article 10(2), point (d) Article 26(2), point (c) \u2014 Article 10(2), point (e) Article 26(2), point (d) \u2014 \u2014 Article 26(2), point (e) \u2014 Article 10(2), point (f) Article 26(2), point (f) \u2014 Article 10(3), point (a) Article 26(3), point (a) \u2014 \u2014 Article 26(3), point (b) \u2014 Article 10(3), point (c) Article 26(3), point (c) \u2014 Article 10(5) Article 26(4) \u2014 Article 10(6) Article 26(5) \u2014 Article 10(4) Article 26(6) \u2014 \u2014 Article 27 \u2014 Article 12(1) Article 28(1) \u2014 Article 12(2), points (a), (b), and (c) Article 28(2), points (a), (b) and (c) \u2014 \u2014 Article 28(2), point (d) \u2014 Article 12(2), point (d) Article 28(2), point (e) \u2014 Article 12(2), point (e) Article 28(2), point (f) \u2014 \u2014 Article 28(2), points (g), (h) and (i) \u2014 Article 12(4) and (5) Article 28(3) and (4) Article 11 \u2014 Article 29(1), (2), (3) and (5) to (8) \u2014 \u2014 Article 29(4) \u2014 Article 14 Article 30 Article 12 \u2014 Article 31(1), (2) and (4) to (7), and Article 31(3), points (a) to (e), and (g) to (j) \u2014 \u2014 Article 31(3), points (f) and (k) Article 13 \u2014 Article 32(1) to (8), (10) and (11) \u2014 \u2014 Article 32(9) \u2014 \u2014 Article 33 \u2014 Article 15(1) Article 34(1) \u2014 \u2014 Article 34(2) \u2014 \u2014 Article 34(3) \u2014 Article 15(2) Article 34(4) \u2014 Article 15(3) Article 34(5) \u2014 Article 16(1), (2), and (3) Article 35(1), points (a), (b) and (c) and Article 35(2)and (3) \u2014 \u2014 Article 35(1), point (d) \u2014 Article 16(5) Article 35(4) Article 14 \u2014 Article 36(1), (3) and (4) and Article 36(2) points (a) to (e) \u2014 Article 16(4), point (a) Article 36(2), point (f) Article 15(1), (2), and (3) \u2014 Article 37(1), (2), and (3) Article 15(5) \u2014 Article 37(4) Article 16 \u2014 Article 38(1), (2) and (4) and Article 38(3), points (a) to (k) and points (m) to (o) \u2014 \u2014 Article 38(3), point (l) and Article 38(5) Article 17 \u2014 Article 39(1), (2), (3), (5), (7) to (10) and (13) to (15) \u2014 \u2014 Article 39(4), (6), (11) and (12) Article 18 \u2014 Article 40(1), (2), (3) and (5) and Article 40(4), points (a), (b) and (c) \u2014 \u2014 Article 40(4), point (d) Article 15(4) \u2014 Article 41(1) \u2014 \u2014 Article 41(2) Article 19 \u2014 Article 42 Article 21 \u2014 Article 43(1) to (5) \u2014 \u2014 Article 43(6) Article 22 \u2014 Article 44 Article 24(1), points (a) to (e) and Article 24(2) \u2014 Article 45(1) \u2014 \u2014 Article 45(2) Article 25 \u2014 Article 46(1) to (4) and (7) \u2014 \u2014 Article 46(5) and (6) Article 26 \u2014 Article 47 Article 27(1), point (a) \u2014 Article 48(1), point (a)(i) Article 27(1), point (c) \u2014 Article 48(1), point (a) (ii) and(iii) \u2014 \u2014 Article 48(1), point (a)(iv) Article 27(1), point (b) \u2014 Article 48(1), point (b) \u2014 \u2014 Article 48(1), points (c) and (d) Article 27(1), point (d) \u2014 Article 48(1), point (e) Article 27(1), point (e) \u2014 Article 48(1), point (f) Article 27(2) \u2014 Article 48(2), points (a) to (d) \u2014 \u2014 Article 48(2), point (e) Article 27(3) \u2014 Article 48(3) \u2014 \u2014 Article 49 Article 28 \u2014 Article 50 Article 29 \u2014 Article 51 \u2014 \u2014 Article 52(1) Article 32(2) \u2014 Article 52(2) Article 33 \u2014 Article 53 \u2014 \u2014 Article 54 \u2014 \u2014 Article 55 \u2014 \u2014 Article 56 \u2014 \u2014 Article 57 \u2014 \u2014 Article 58 \u2014 \u2014 Article 59 \u2014 \u2014 Article 60 \u2014 \u2014 Article 61 Article 36(1) \u2014 Article 62(1) \u2014 \u2014 Article 62(2) and (3) Article 36(2) \u2014 Article 62(4) Article 36(4) to (8) \u2014 Article 62(5) to (9) \u2014 \u2014 Article 62(10) Article 38(1) \u2014 Article 63(1) \u2014 \u2014 Article 63(2) Article 38(2) to (5) \u2014 Article 63(3) to (6) Article 39(1) to (12) and (14) to (16) \u2014 Article 64 \u2014 \u2014 Article 65(1) and (2) Article 20(12), Article 39(13) \u2014 Article 65(3) \u2014 \u2014 Article 65(4) Article 37 \u2014 Article 66(1) to (4) \u2014 \u2014 Article 66(5) \u2014 \u2014 Article 67 Article 52(1) Article 18(1), (2) and (3) Article 68(1), first subparagraph and second subparagraph, points (a) to (g) \u2014 \u2014 Article 68(1), point (i) and (j) \u2014 \u2014 Article 68(1), third subparagraph, points (a) to (d) \u2014 Article 18(3) Article 68(1), third subparagraph, point (e) Article 52(2) Article 18(5) Article 68(2) Article 52(4) Article 18(5) Article 68(3) Article 52(3) \u2014 Article 68(4) Article 52(4) Article 18(6) Article 68(5) \u2014 Article 18(4) Article 68(6) Article 53 \u2014 Article 69 Article 51(1) \u2014 Article 70(1) \u2014 Article 19 Article 70(2) to (6) Article 51(2) and (3) \u2014 Article 70(7) and (8) Article 54(1) and (2) \u2014 Article 71(1), (2) and (3) \u2014 \u2014 Article 71(4) \u2014 Article 20(1) Article 72(1) \u2014 \u2014 Article 72(2) \u2014 Article 20(3) Article 72(3) Article 54(2) \u2014 Article 73(1) and (2) Article 54(4) \u2014 Article 73(3) and (4) Article 54(8) \u2014 Article 73(5) Article 54(9) \u2014 Article 73(6) Article 54(11) \u2014 Article 73(7) and (8) Article 54(3) \u2014 Article 74(1), (2) and (3) \u2014 \u2014 Article 74(4), (5) and (6) \u2014 Article 20(1) Article 75(1) and (2) \u2014 Article 20(7) Article 75(3) Article 54(5) \u2014 Article 76(1) \u2014 \u2014 Article 76(2), (3) and (4) Article 55(4) \u2014 Article 76(5) Article 55(1), (2) and (3) \u2014 Article 77(1), (2) and (3) \u2014 \u2014 Article 77(4) Article 52(5) \u2014 Article 78(1) Article 54(7) \u2014 Article 78(2) \u2014 \u2014 Article 78(3) \u2014 \u2014 Article 79 Article 34 \u2014 Article 80 Article 35 \u2014 Article 81 Article 40 \u2014 Article 82(1), (3), (4) and (6) to (11) \u2014 \u2014 Article 82(2) and (5) Article 41 \u2014 Article 83 Article 42 \u2014 Article 84 Article 43 \u2014 Article 85 Article 45(1) and (2) \u2014 Article 86(1) and (2) \u2014 \u2014 Article 86(3), (4) and (5) Article 46(1) \u2014 Article 87(1), points (a), (b), (c), (e), (f), and (h) \u2014 \u2014 Article 87(1), points (d) and (g) Article 46(3) and (4) \u2014 Article 87(2) and (3) \u2014 \u2014 Article 88(1), first subparagraph Article 47(1), points (b) and (c) \u2014 Article 88(1), second subparagraph, points (a) and (c) \u2014 \u2014 Article 88(1), second subparagraph, point (b) Article 47(2) \u2014 Article 88(2), points (a) and (c) \u2014 \u2014 Article 88(2), point (b) \u2014 Article 13 Article 89(1) and (2) \u2014 \u2014 Article 89(3) \u2014 Article 20(4) and (5) Article 89(4) and (5) \u2014 \u2014 Article 89(6) \u2014 \u2014 Article 90 \u2014 \u2014 Article 91 Article 50 \u2014 Article 92 Article 56 \u2014 Article 93 Article 57 \u2014 Article 94 Article 58 \u2014 Article 95(1), (4), (5) and (6) \u2014 \u2014 Article 95(2) and (3) Article 59 \u2014 Article 96 Article 60 \u2014 Article 97 \u2014 \u2014 Article 98 Article 61 \u2014 Article 99 Article 62(1) and (3) to (8) \u2014 Article 100(1) and (3) to (8) Article 62(2), first subparagraph, points (a) to (g) and points (i) to (z) \u2014 Article 100(2), first subparagraph, points (a), (b), (d), (f) to (z) and point (ab) \u2014 \u2014 Article 100(2), first subparagraph, points (c), (e), (aa), (ac), (ad), (ae) Article 62(2), second subparagraph \u2014 Article 100(2), second subparagraph Article 63 \u2014 Article 101 Article 64 \u2014 Article 102 Article 65 \u2014 Article 103 Article 66 \u2014 Article 104(1) to (5) and (7) to (9) \u2014 \u2014 Article 104(6) Article 67 \u2014 Article 105 Article 68(1), (2) and (3), points (a) to (j) and points (l) to (r) \u2014 Article 106(1), (2), (5) and (6) and Article 106(4), points (a) to (l), (n), (o), (r), (s) and (t) \u2014 \u2014 Article 106(3) \u2014 \u2014 Article 106(4), points (m), (p) and (q) Article 69 \u2014 Article 107(1) to (7) \u2014 \u2014 Article 107(8) Article 70 \u2014 Article 108 Article 71 \u2014 Article 109(1), (4) and (7) \u2014 \u2014 Article 109(2), (3), (5)and (6) \u2014 \u2014 Article 110 Article 72 \u2014 Article 111 \u2014 \u2014 Article 112 Article 73 \u2014 Article 113 Article 74 \u2014 Article 114 Article 75 \u2014 Article 115(1) to (14) \u2014 \u2014 Article 115(15) Article 76 \u2014 Article 116 Article 77 \u2014 Article 117(1), (2), (3) and (5) \u2014 \u2014 Article 117(4) Article 78 \u2014 Article 118 \u2014 \u2014 Article 119 Article 79 \u2014 Article 120 Article 81(1) \u2014 Article 121(1), first subparagraph, points (a) to (e) and Article 121(1), second subparagraph \u2014 \u2014 Article 121(1), first subparagraph, points (f) and (g) \u2014 \u2014 Article 121(2) and (3) Article 81(2) \u2014 Article 121(4) \u2014 Article 22(2) Article 121(5) \u2014 Article 22(3) and (4) Article 121(6) \u2014 \u2014 Article 122 Article 82 \u2014 Article 123 Article 83 \u2014 Article 124 Article 2, points (3) and (4) \u2014 \u2014 Article 8(1), point (k) \u2014 \u2014 Article 8(1), points (t) and (u) \u2014 \u2014 Article 20(3) to (11) \u2014 \u2014 Article 27(1), point (c) \u2014 \u2014 Article 27(4) \u2014 \u2014 Article 30 \u2014 \u2014 Article 31 \u2014 \u2014 Article 32(1) \u2014 \u2014 Article 36(3) \u2014 \u2014 Article 44(2) \u2014 \u2014 Article 45(3) and (4) \u2014 \u2014 Article 46(2), (3) and (4) \u2014 \u2014 Article 47(3) \u2014 \u2014 Article 48 \u2014 \u2014 Article 49 \u2014 \u2014 Article 62(2), first subparagraph, point (h) \u2014 \u2014 \u2014 Article 2(4) \u2014 \u2014 Article 3, point (a) \u2014 \u2014 Article 3, point, (h) \u2014 \u2014 Article 4(1), points (c), (e) and (f) \u2014 \u2014 Article 4(4) \u2014 \u2014 Article 6(1), points (b), (c), (d) \u2014 \u2014 Article 6(2) \u2014 \u2014 Article 7(3), (4) and (5) \u2014 \u2014 Article 9(2), point (k) \u2014 \u2014 Article 9(5), point (b) \u2014 \u2014 Article 9(6) \u2014 \u2014 Article 9(7) \u2014 \u2014 Article 9(8) \u2014 \u2014 Article 9(9) \u2014 \u2014 Article 9(10) \u2014 \u2014 Article 10(2), points (c) and (f) \u2014 \u2014 Article 10(7) \u2014 \u2014 Article 11 \u2014 \u2014 Article 12(3) \u2014 \u2014 Article 16(4) \u2014 \u2014 Article 20(2) \u2014 \u2014 Article 20(6) \u2014 \u2014 Article 20(8) \u2014 \u2014 Article 20(9) \u2014 \u2014 Article 23 \u2014 \u2014 Article 24 \u2014", "summary": "European Border and Coast Guard European Border and Coast Guard SUMMARY OF: Regulation (EU) 2019/1896 on the European Border and Coast Guard WHAT IS THE AIM OF THE REGULATION? It establishes a European Border and Coast Guard agency to: assure European integrated management at the EU\u2019s border; manage border crossing efficiently; and make the EU\u2019s return* policy more effective as a key component of sustainable migration management. It aims to address migratory challenges and potential future threats at the borders, combat serious international crime, and ensure internal EU security while fully respecting fundamental rights and safeguarding free movement. KEY POINTS A standing corps of 10,000 border guards: will ensure that the agency can support EU Member States whenever and wherever needed; will bring together agency staff, as well as border guards and return experts seconded or deployed by Member States, who will support the over 100,000 national border guards in their tasks. In addition, the agency will have a budget to acquire its own equipment, such as vessels, planes and vehicles. Executive powers The standing corps will be able to carry out border control and return tasks, such as identity checks, authorising entry at the external borders, and carrying out border surveillance \u2014 only with the agreement of the host Member State. More support on return In addition to organising and financing joint return operations, the agency will now also be able to support Member States at all stages of return process with Member States remaining responsible for taking return decisions. This support can now also include, for example, providing assistance to returnees before, during and post-arrival, as well as identifying non-EU nationals with no right to stay or acquiring travel documents. Stronger cooperation with non-EU countries The agency will be able \u2014 subject to prior agreement of the country concerned \u2014 to launch joint operations and deploy staff outside the EU, beyond countries neighbouring the EU, to provide support on border management. Antenna offices The agency will be able to set up antenna offices in Member States and in a non-EU country (subject to a status agreement) to support logistically its operational activities and guarantee the smooth running of operations. European Border Surveillance System (Eurosur) To improve Eurosur\u2019s operation, the regulation incorporates it in the functioning of the European Border and Coast Guard. The regulation enlarges Eurosur\u2019s scope to cover most of the components of European integrated border management. This means being able to better detect, anticipate and react to crisis situations at the EU\u2019s external borders and in non-EU countries. A European Commission implementing act, Implementing Regulation (EU) 2021/581 sets out the rules concerning information exchange and cooperation for the purposes of Eurosur including situational awareness, risk analysis and for supporting the planning and conduct of border control operations. It lays down: the rules for reporting in Eurosur, including the type of information to be provided and the time limits for reporting; the details of the information layers * of the situational pictures *; the procedures for establishing specific situational pictures; the responsibilities related to the reporting, to managing the situational pictures and for operating and maintaining the various technical systems and networks that support Eurosur; Eurosur\u2019s data security and data protection rules; quality control mechanisms. Repeal It repeals Regulations (EU) No 1052/2013 on Eurosur from 4 December 2019 and (EU) 2016/1624 from 31 December 2020. FROM WHEN DOES THE REGULATION APPLY? It has applied since 4 December 2019. BACKGROUND For more information, see: European Border and Coast Guard: The Commission welcomes agreement on a standing corps of 10,000 border guards by 2027 \u2014 press release (European Commission) EU Protects: European Border and Coast Guard \u2014 YouTube (European Commission). KEY TERMS Return: the process of a non-EU national going back voluntarily or enforced to their country of origin, an agreed country of transit, or another Member State to which the person concerned voluntarily decides to return and where they will be accepted. Information layers: situational pictures (see next entry) comprise 3 information layers: an events layer (reports on events likely to have an impact on the external border); an operational layer (reports on Member States\u2019 own assets, reports on operational plans, as well as reports on environmental information including, in particular, meteorological and oceanographic information); and an analysis layer, based on risks analysis reports. Analysis reports aim to enhance the understanding of events at the external border which can facilitate the forecasting of trends, the planning and conduct of border control operations, as well as strategic risk analysis. Situational pictures: these contain information on the situation at European borders and the pre-frontier area. MAIN DOCUMENT Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, pp. 1-131) RELATED DOCUMENTS Commission Implementing Regulation (EU) 2021/581 of 9 April 2021 on the situational pictures of the European Border Surveillance System (EUROSUR) (OJ L 124, 12.4.2021, pp. 3-39) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, pp. 1-52) Successive amendments to Regulation (EU) 2016/399 have been incorporated into the original text. This consolidated version is of documentary value only. last update 29.05.2021"}
{"article": "7.6.2019 EN Official Journal of the European Union L 151/15 REGULATION (EU) 2019/881 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Network and information systems and electronic communications networks and services play a vital role in society and have become the backbone of economic growth. Information and communications technology (ICT) underpins the complex systems which support everyday societal activities, keep our economies running in key sectors such as health, energy, finance and transport, and, in particular, support the functioning of the internal market. (2) The use of network and information systems by citizens, organisations and businesses across the Union is now pervasive. Digitisation and connectivity are becoming core features in an ever growing number of products and services and with the advent of the internet of Things (IoT) an extremely high number of connected digital devices are expected to be deployed across the Union during the next decade. While an increasing number of devices is connected to the internet, security and resilience are not sufficiently built in by design, leading to insufficient cybersecurity. In that context, the limited use of certification leads to individual, organisational and business users having insufficient information about the cybersecurity features of ICT products, ICT services and ICT processes, which undermines trust in digital solutions. Network and information systems are capable of supporting all aspects of our lives and drive the Union\u2019s economic growth. They are the cornerstone for achieving the digital single market. (3) Increased digitisation and connectivity increase cybersecurity risks, thus making society as a whole more vulnerable to cyber threats and exacerbating the dangers faced by individuals, including vulnerable persons such as children. In order to mitigate those risks, all necessary actions need to be taken to improve cybersecurity in the Union so that network and information systems, communications networks, digital products, services and devices used by citizens, organisations and businesses \u2013 ranging from small and medium-sized enterprises (SMEs), as defined in Commission Recommendation 2003/361/EC (4), to operators of critical infrastructure \u2013 are better protected from cyber threats. (4) By making the relevant information available to the public, the European Union Agency for Network and Information Security (ENISA), as established by Regulation (EU) No 526/2013 of the European Parliament and of the Council (5) contributes to the development of the cybersecurity industry in the Union, in particular SMEs and start-ups. ENISA should strive for closer cooperation with universities and research entities in order to contribute to reducing dependence on cybersecurity products and services from outside the Union and to reinforce supply chains inside the Union. (5) Cyberattacks are on the increase and a connected economy and society that is more vulnerable to cyber threats and attacks requires stronger defences. However, while cyberattacks often take place across borders, the competence of, and policy responses by, cybersecurity and law enforcement authorities are predominantly national. Large-scale incidents could disrupt the provision of essential services across the Union. This necessitates effective and coordinated responses and crisis management at Union level, building on dedicated policies and wider instruments for European solidarity and mutual assistance. Moreover, a regular assessment of the state of cybersecurity and resilience in the Union, based on reliable Union data, as well as systematic forecasts of future developments, challenges and threats, at Union and global level, are important for policy makers, industry and users. (6) In light of the increased cybersecurity challenges faced by the Union, there is a need for a comprehensive set of measures that would build on previous Union action and would foster mutually reinforcing objectives. Those objectives include further increasing the capabilities and preparedness of Member States and businesses, as well as improving cooperation, information sharing and coordination across Member States and Union institutions, bodies, offices and agencies. Furthermore, given the borderless nature of cyber threats, there is a need to increase capabilities at Union level that could complement the action of Member States, in particular in cases of large-scale cross-border incidents and crises, while taking into account the importance of maintaining and further enhancing the national capabilities to respond to cyber threats of all scales. (7) Additional efforts are also needed to increase citizens\u2019, organisations\u2019 and businesses\u2019 awareness of cybersecurity issues. Moreover, given that incidents undermine trust in digital service providers and in the digital single market itself, especially among consumers, trust should be further strengthened by offering information in a transparent manner on the level of security of ICT products, ICT services and ICT processes that stresses that even a high level of cybersecurity certification cannot guarantee that an ICT product, ICT service or ICT process is completely secure. An increase in trust can be facilitated by Union-wide certification providing for common cybersecurity requirements and evaluation criteria across national markets and sectors. (8) Cybersecurity is not only an issue related to technology, but one where human behaviour is equally important. Therefore, \u2018cyber-hygiene\u2019, namely, simple, routine measures that, where implemented and carried out regularly by citizens, organisations and businesses, minimise their exposure to risks from cyber threats, should be strongly promoted. (9) For the purpose of strengthening Union cybersecurity structures, it is important to maintain and develop the capabilities of Member States to comprehensively respond to cyber threats, including to cross-border incidents. (10) Businesses and individual consumers should have accurate information regarding the assurance level with which the security of their ICT products, ICT services and ICT processes has been certified. At the same time, no ICT product or ICT service is wholly cyber-secure and basic rules of cyber-hygiene have to be promoted and prioritised. Given the growing availability of IoT devices, there is a range of voluntary measures that the private sector can take to reinforce trust in the security of ICT products, ICT services and ICT processes. (11) Modern ICT products and systems often integrate and rely on one or more third-party technologies and components such as software modules, libraries or application programming interfaces. This reliance, which is referred to as a \u2018dependency\u2019, could pose additional cybersecurity risks as vulnerabilities found in third-party components could also affect the security of the ICT products, ICT services and ICT processes. In many cases, identifying and documenting such dependencies enables end users of ICT products, ICT services and ICT processes to improve their cybersecurity risk management activities by improving, for example, users\u2019 cybersecurity vulnerability management and remediation procedures. (12) Organisations, manufacturers or providers involved in the design and development of ICT products, ICT services or ICT processes should be encouraged to implement measures at the earliest stages of design and development to protect the security of those products, services and processes to the highest possible degree, in such a way that the occurrence of cyberattacks is presumed and their impact is anticipated and minimised (\u2018security-by-design\u2019). Security should be ensured throughout the lifetime of the ICT product, ICT service or ICT process by design and development processes that constantly evolve to reduce the risk of harm from malicious exploitation. (13) Undertakings, organisations and the public sector should configure the ICT products, ICT services or ICT processes designed by them in a way that ensures a higher level of security which should enable the first user to receive a default configuration with the most secure settings possible (\u2018security by default\u2019), thereby reducing the burden on users of having to configure an ICT product, ICT service or ICT process appropriately. Security by default should not require extensive configuration or specific technical understanding or non-intuitive behaviour on the part of the user, and should work easily and reliably when implemented. If, on a case-by-case basis, a risk and usability analysis leads to the conclusion that such a setting by default is not feasible, users should be prompted to opt for the most secure setting. (14) Regulation (EC) No 460/2004 of the European Parliament and of the Council (6) established ENISA with the purposes of contributing to the goals of ensuring a high and effective level of network and information security within the Union, and developing a culture of network and information security for the benefit of citizens, consumers, enterprises and public administrations. Regulation (EC) No 1007/2008 of the European Parliament and of the Council (7) extended ENISA\u2019s mandate until March 2012. Regulation (EU) No 580/2011 of the European Parliament and of the Council (8) further extended ENISA\u2019s mandate until 13 September 2013. Regulation (EU) No 526/2013 extended ENISA\u2019s mandate until 19 June 2020. (15) The Union has already taken important steps to ensure cybersecurity and to increase trust in digital technologies. In 2013, the Cybersecurity Strategy of the European Union was adopted to guide the Union\u2019s policy response to cyber threats and risks. In an effort to better protect citizens online, the Union\u2019s first legal act in the field of cybersecurity was adopted in 2016 in the form of Directive (EU) 2016/1148 of the European Parliament and of the Council (9). Directive (EU) 2016/1148 put in place requirements concerning national capabilities in the field of cybersecurity, established the first mechanisms to enhance strategic and operational cooperation between Member States, and introduced obligations concerning security measures and incident notifications across sectors which are vital for the economy and society, such as energy, transport, drinking water supply and distribution, banking, financial market infrastructures, healthcare, digital infrastructure as well as key digital service providers (search engines, cloud computing services and online marketplaces). A key role was attributed to ENISA in supporting the implementation of that Directive. In addition, fighting effectively against cybercrime is an important priority in the European Agenda on Security, contributing to the overall aim of achieving a high level of cybersecurity. Other legal acts such as Regulation (EU) 2016/679 of the European Parliament and of the Council (10) and Directives 2002/58/EC (11) and (EU) 2018/1972 (12) of the European Parliament and of the Council also contribute to a high level of cybersecurity in the digital single market. (16) Since the adoption of the Cybersecurity Strategy of the European Union in 2013 and the last revision of ENISA\u2019s mandate, the overall policy context has changed significantly as the global environment has become more uncertain and less secure. Against that background and in the context of the positive development of the role of ENISA as a reference point for advice and expertise, as a facilitator of cooperation and of capacity-building as well as within the framework of the new Union cybersecurity policy, it is necessary to review ENISA\u2019s mandate, to establish its role in the changed cybersecurity ecosystem and to ensure that it contributes effectively to the Union\u2019s response to cybersecurity challenges emanating from the radically transformed cyber threat landscape, for which, as recognised during the evaluation of ENISA, the current mandate is not sufficient. (17) ENISA as established by this Regulation should succeed ENISA as established by Regulation (EU) No 526/2013. ENISA should carry out the tasks conferred on it by this Regulation and other legal acts of the Union in the field of cybersecurity, among other things, by providing advice and expertise and by acting as a Union centre of information and knowledge. It should promote the exchange of best practices between Member States and private stakeholders, offer policy suggestions to the Commission and the Member States, act as a reference point for Union sectoral policy initiatives with regard to cybersecurity matters, and foster operational cooperation, both between Member States and between the Member States and Union institutions, bodies, office and agencies. (18) Within the framework of Decision 2004/97/EC, Euratom taken by common agreement between the Representatives of the Member States, meeting at Head of State or Government level (13), the representatives of the Member States decided that ENISA would have its seat in a town in Greece to be determined by the Greek Government. ENISA\u2019s host Member State should ensure the best possible conditions for the smooth and efficient operation of ENISA. It is imperative for the proper and efficient performance of its tasks, for staff recruitment and retention and for enhancing the efficiency of networking activities that ENISA be based in an appropriate location, among other things providing appropriate transport connections and facilities for spouses and children accompanying members of staff of ENISA. The necessary arrangements should be laid down in an agreement between ENISA and the host Member State concluded after obtaining the approval of the Management Board of ENISA. (19) Given the increasing cybersecurity risks and challenges the Union is facing, the financial and human resources allocated to ENISA should be increased to reflect its enhanced role and tasks, and its critical position in the ecosystem of organisations defending the digital ecosystem of the Union, allowing ENISA to effectively carry out the tasks conferred on it by this Regulation. (20) ENISA should develop and maintain a high level of expertise and operate as a reference point, establishing trust and confidence in the single market by virtue of its independence, the quality of the advice it delivers, the quality of information it disseminates, the transparency of its procedures, the transparency of its methods of operation, and its diligence in carrying out its tasks. ENISA should actively support national efforts and should proactively contribute to Union efforts while carrying out its tasks in full cooperation with the Union institutions, bodies, offices and agencies and with the Member States, avoiding any duplication of work and promoting synergy. In addition, ENISA should build on input from and cooperation with the private sector as well as other relevant stakeholders. A set of tasks should establish how ENISA is to accomplish its objectives while allowing flexibility in its operations. (21) In order to be able to provide adequate support to the operational cooperation between Member States, ENISA should further strengthen its technical and human capabilities and skills. ENISA should increase its know-how and capabilities. ENISA and Member States, on a voluntary basis, could develop programmes for seconding national experts to ENISA, creating pools of experts and staff exchanges. (22) ENISA should assist the Commission by means of advice, opinions and analyses regarding all Union matters related to policy and law development, updates and reviews in the field of cybersecurity and sector-specific aspects thereof in order to enhance the relevance of Union policies and laws with a cybersecurity dimension and to enable consistency in the implementation of those policies and laws at national level. ENISA should act as a reference point for advice and expertise for Union sector-specific policy and law initiatives where matters related to cybersecurity are involved. ENISA should regularly inform the European Parliament about its activities. (23) The public core of the open internet, namely its main protocols and infrastructure, which are a global public good, provides the essential functionality of the internet as a whole and underpins its normal operation. ENISA should support the security of the public core of the open internet and the stability of its functioning, including, but not limited to, key protocols (in particular DNS, BGP, and IPv6), the operation of the domain name system (such as the operation of all top-level domains), and the operation of the root zone. (24) The underlying task of ENISA is to promote the consistent implementation of the relevant legal framework, in particular the effective implementation of Directive (EU) 2016/1148 and other relevant legal instruments containing cybersecurity aspects, which is essential to increasing cyber resilience. In light of the fast evolving cyber threat landscape, it is clear that Member States have to be supported by more comprehensive, cross-policy approach to building cyber resilience. (25) ENISA should assist the Member States and Union institutions, bodies, offices and agencies in their efforts to build and enhance capabilities and preparedness to prevent, detect and respond to cyber threats and incidents and in relation to the security of network and information systems. In particular, ENISA should support the development and enhancement of national and Union computer security incident response teams (\u2018CSIRTs\u2019) provided for in Directive (EU) 2016/1148, with a view to achieving a high common level of their maturity in the Union. Activities carried out by ENISA relating to the operational capacities of Member States should actively support actions taken by Member States to comply with their obligations under Directive (EU) 2016/1148 and therefore should not supersede them. (26) ENISA should also assist with the development and updating of strategies on the security of network and information systems at Union level and, upon request, at Member State level, in particular on cybersecurity, and should promote the dissemination of such strategies and follow the progress of their implementation. ENISA should also contribute to covering the need for training and training materials, including the needs of public bodies, and where appropriate, to a high extent, \u2018train the trainers\u2019, building on the Digital Competence Framework for Citizens with a view to assisting Member States and Union institutions, bodies, offices and agencies in developing their own training capabilities. (27) ENISA should support Member States in the field of cybersecurity awareness-raising and education by facilitating closer coordination and the exchange of best practices between Member States. Such support could consist in the development of a network of national education points of contact and the development of a cybersecurity training platform. The network of national education points of contact could operate within the National Liaison Officers Network and be a starting point for future coordination within the Members States. (28) ENISA should assist the Cooperation Group created by Directive (EU) 2016/1148 in the execution of its tasks, in particular by providing expertise, advice and by facilitating the exchange of best practices, inter alia, with regard to the identification of operators of essential services by Member States, as well as in relation to cross-border dependencies, regarding risks and incidents. (29) With a view to stimulating cooperation between the public and private sector and within the private sector, in particular to support the protection of the critical infrastructures, ENISA should support information sharing within and among sectors, in particular the sectors listed in Annex II to Directive (EU) 2016/1148, by providing best practices and guidance on available tools and on procedure, as well as by providing guidance on how to address regulatory issues related to information sharing, for example through facilitating the establishment of sectoral information sharing and analysis centres. (30) Whereas the potential negative impact of vulnerabilities in ICT products, ICT services and ICT processes is constantly increasing, finding and remedying such vulnerabilities plays an important role in reducing the overall cybersecurity risk. Cooperation between organisations, manufacturers or providers of vulnerable ICT products, ICT services and ICT processes and members of the cybersecurity research community and governments who find vulnerabilities has been proven to significantly increase both the rate of discovery and the remedy of vulnerabilities in ICT products, ICT services and ICT processes. Coordinated vulnerability disclosure specifies a structured process of cooperation in which vulnerabilities are reported to the owner of the information system, allowing the organisation the opportunity to diagnose and remedy the vulnerability before detailed vulnerability information is disclosed to third parties or to the public. The process also provides for coordination between the finder and the organisation as regards the publication of those vulnerabilities. Coordinated vulnerability disclosure policies could play an important role in Member States\u2019 efforts to enhance cybersecurity. (31) ENISA should aggregate and analyse voluntarily shared national reports from CSIRTs and the inter-institutional computer emergency response team for the Union\u2019s institutions, bodies and agencies established by the Arrangement between the European Parliament, the European Council, the Council of the European Union, the European Commission, the Court of Justice of the European Union, the European Central Bank, the European Court of Auditors, the European External Action Service, the European Economic and Social Committee, the European Committee of the Regions and the European Investment Bank on the organisation and operation of a computer emergency response team for the Union\u2019s institutions, bodies and agencies (CERT-EU) (14) in order to contribute to the setting up of common procedures, language and terminology for the exchange of information. In that context ENISA should involve the private sector within the framework of Directive (EU) 2016/1148 which lays down the grounds for the voluntary exchange of technical information at the operational level, in the computer security incident response teams network (\u2018CSIRTs network\u2019) created by that Directive. (32) ENISA should contribute to responses at Union level in the case of large-scale cross-border incidents and crises related to cybersecurity. That task should be performed in accordance with ENISA\u2019s mandate under this Regulation and an approach to be agreed by Member States in the context of Commission Recommendation (EU) 2017/1584 (15) and the Council conclusions of 26 June 2018 on EU Coordinated Response to Large-Scale Cybersecurity Incidents and Crises. That task could include gathering relevant information and acting as a facilitator between the CSIRTs network and the technical community, as well as between decision makers responsible for crisis management. Furthermore, ENISA should support operational cooperation among Member States, where requested by one or more Member States, in the handling of incidents from a technical perspective, by facilitating relevant exchanges of technical solutions between Member States, and by providing input into public communications. ENISA should support operational cooperation by testing the arrangements for such cooperation through regular cybersecurity exercises. (33) In supporting operational cooperation, ENISA should make use of the available technical and operational expertise of CERT-EU through structured cooperation. Such structured cooperation could build on ENISA\u2019s expertise. Where appropriate, dedicated arrangements between the two entities should be established to define the practical implementation of such cooperation and to avoid the duplication of activities. (34) In performing its task to support operational cooperation within the CSIRTs network, ENISA should be able to provide support to Member States at their request, such as by providing advice on how to improve their capabilities to prevent, detect and respond to incidents, by facilitating the technical handling of incidents having a significant or substantial impact or by ensuring that cyber threats and incidents are analysed. ENISA should facilitate the technical handling of incidents having a significant or substantial impact in particular by supporting the voluntary sharing of technical solutions between Member States or by producing combined technical information, such as technical solutions voluntarily shared by the Member States. Recommendation (EU) 2017/1584 recommends that Member States cooperate in good faith and share among themselves and with ENISA information on large-scale incidents and crises related to cybersecurity without undue delay. Such information would further help ENISA in performing its task of supporting operational cooperation. (35) As part of the regular cooperation at technical level to support Union situational awareness, ENISA, in close cooperation with the Member States, should prepare a regular in-depth EU Cybersecurity Technical Situation Report on incidents and cyber threats, based on publicly available information, its own analysis and reports shared with it by Member States\u2019 CSIRTs or the national single points of contact on the security of network and information systems (\u2018single points of contact\u2019) provided for in Directive (EU) 2016/1148, both on a voluntary basis, the European Cybercrime Centre (EC3) at Europol, CERT-EU and, where appropriate, the European Union Intelligence and Situation Centre (EU INTCEN) at the European External Action Service. That report should be made available to the Council, the Commission, the High Representative of the Union for Foreign Affairs and Security Policy and the CSIRTs network. (36) The support by ENISA for ex-post technical inquiries of incidents having a significant or substantial impact undertaken at the request of the Member States concerned should focus on the prevention of future incidents. The Member States concerned should provide the necessary information and assistance in order to enable ENISA to support the ex-post technical inquiry effectively. (37) Member States may invite the undertakings concerned by the incident to cooperate by providing necessary information and assistance to ENISA without prejudice to their right to protect commercially sensitive information and information that is relevant to public security. (38) To understand better the challenges in the area of cybersecurity, and with a view to providing strategic long-term advice to Member States and Union institutions, bodies, offices and agencies, ENISA needs to analyse current and emerging cybersecurity risks. For that purpose, ENISA should, in cooperation with Member States and, as appropriate, with statistical bodies and other bodies, collect relevant publicly available or voluntarily shared information and perform analyses of emerging technologies and provide topic-specific assessments on the expected societal, legal, economic and regulatory impact of technological innovations on network and information security, in particular cybersecurity. ENISA should, furthermore, support Member States and Union institutions, bodies, offices and agencies in identifying emerging cybersecurity risks and preventing incidents, by performing analyses of cyber threats, vulnerabilities and incidents. (39) In order to increase the resilience of the Union, ENISA should develop expertise in the field of cybersecurity of infrastructures, in particular to support the sectors listed in Annex II to Directive (EU) 2016/1148 and those used by the providers of the digital services listed in Annex III to that Directive, by providing advice, issuing guidelines and exchanging best practices. With a view to ensuring easier access to better-structured information on cybersecurity risks and possible remedies, ENISA should develop and maintain the \u2018information hub\u2019 of the Union, a one-stop-shop portal providing the public with information on cybersecurity originating in Union and national institutions, bodies, offices and agencies. Facilitating access to better-structured information on cybersecurity risks and possible remedies could also help Member States bolster their capacities and align their practices, thus increasing their overall resilience to cyberattacks. (40) ENISA should contribute to raising the public\u2019s awareness of cybersecurity risks, including through an EU-wide awareness-raising campaign by promoting education, and to providing guidance on good practices for individual users aimed at citizens, organisations and businesses. ENISA should also contribute to promoting best practices and solutions, including cyber-hygiene and cyber-literacy at the level of citizens, organisations and businesses by collecting and analysing publicly available information regarding significant incidents, and by compiling and publishing reports and guidance for citizens, organisations and businesses, to improve their overall level of preparedness and resilience. ENISA should also strive to provide consumers with relevant information on applicable certification schemes, for example by providing guidelines and recommendations. ENISA should furthermore organise, in line with the Digital Education Action Plan established in the Commission Communication of 17 January 2018 and in cooperation with the Member States and Union institutions, bodies, offices and agencies regular outreach and public education campaigns directed at end users, to promote safer online behaviour by individuals and digital literacy, to raise awareness of potential cyber threats, including online criminal activities such as phishing attacks, botnets, financial and banking fraud, data fraud incidents, and to promote basic multi-factor authentication, patching, encryption, anonymisation and data protection advice. (41) ENISA should play a central role in accelerating end-user awareness of the security of devices and the secure use of services, and should promote security-by-design and privacy-by-design at Union level. In pursuing that objective, ENISA should make use of available best practices and experience, especially the best practices and experience of academic institutions and IT security researchers. (42) In order to support the businesses operating in the cybersecurity sector, as well as the users of cybersecurity solutions, ENISA should develop and maintain a \u2018market observatory\u2019 by performing regular analyses and disseminating information on the main trends in the cybersecurity market, on both the demand and supply sides. (43) ENISA should contribute to the Union\u2019s efforts to cooperate with international organisations as well as within relevant international cooperation frameworks in the field of cybersecurity. In particular, ENISA should contribute, where appropriate, to cooperation with organisations such as the OECD, the OSCE and NATO. Such cooperation could include joint cybersecurity exercises and joint incident response coordination. Those activities are to be carried out in full respect of the principles of inclusiveness, reciprocity and the decision-making autonomy of the Union, without prejudice to the specific character of the security and defence policy of any Member State. (44) In order to ensure that it fully achieves its objectives, ENISA should liaise with the relevant Union supervisory authorities and with other competent authorities in the Union, Union institutions, bodies, offices and agencies, including CERT-EU, EC3, the European Defence Agency (EDA), the European Global Navigation Satellite Systems Agency (European GNSS Agency), the Body of European Regulators for Electronic Communications (BEREC), the European Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), the European Central Bank (ECB), the European Banking Authority (EBA), the European Data Protection Board, the Agency for the Cooperation of Energy Regulators (ACER), the European Union Aviation Safety Agency (EASA) and any other Union agency involved in cybersecurity. ENISA should also liaise with authorities that deal with data protection in order to exchange know-how and best practices and should provide advice on cybersecurity issues that might have an impact on their work. Representatives of national and Union law enforcement and data protection authorities should be eligible to be represented in the ENISA Advisory Group. In liaising with law enforcement authorities regarding network and information security issues that might have an impact on their work, ENISA should respect existing channels of information and established networks. (45) Partnerships could be established with academic institutions that have research initiatives in relevant fields, and there should be appropriate channels for input from consumer organisations and other organisations, which should be taken into consideration. (46) ENISA, in its role as the secretariat of the CSIRTs network, should support Member States\u2019 CSIRTs and the CERT-EU in the operational cooperation in relation to the relevant tasks of the CSIRTs network, as referred to in Directive (EU) 2016/1148. Furthermore, ENISA should promote and support cooperation between the relevant CSIRTs in the event of incidents, attacks or disruptions of networks or infrastructure managed or protected by the CSIRTs and involving or being capable of involving at least two CSIRTs while taking due account of the Standard Operating Procedures of the CSIRTs network. (47) With a view to increasing Union preparedness in responding to incidents, ENISA should regularly organise cybersecurity exercises at Union level, and, at their request, support Member States and Union institutions, bodies, offices and agencies in organising such exercises. Large-scale comprehensive exercises which include technical, operational or strategic elements should be organised on a biennial basis. In addition, ENISA should be able to regularly organise less comprehensive exercises with the same goal of increasing Union preparedness in responding to incidents. (48) ENISA should further develop and maintain its expertise on cybersecurity certification with a view to supporting the Union policy in that area. ENISA should build on existing best practices and should promote the uptake of cybersecurity certification within the Union, including by contributing to the establishment and maintenance of a cybersecurity certification framework at Union level (European cybersecurity certification framework) with a view to increasing the transparency of the cybersecurity assurance of ICT products, ICT services and ICT processes, thereby strengthening trust in the digital internal market and its competitiveness. (49) Efficient cybersecurity policies should be based on well-developed risk assessment methods, in both the public and private sectors. Risk assessment methods are used at different levels, with no common practice regarding how to apply them efficiently. Promoting and developing best practices for risk assessment and for interoperable risk management solutions in public-sector and private-sector organisations will increase the level of cybersecurity in the Union. To that end, ENISA should support cooperation between stakeholders at Union level and facilitate their efforts relating to the establishment and take-up of European and international standards for risk management and for the measurable security of electronic products, systems, networks and services which, together with software, comprise the network and information systems. (50) ENISA should encourage Member States, manufacturers or providers of ICT products, ICT services or ICT processes to raise their general security standards so that all internet users can take the necessary steps to ensure their own personal cybersecurity and should give incentives to do so. In particular, manufacturers and providers of ICT products, ICT services or ICT processes should provide any necessary updates and should recall, withdraw or recycle ICT products, ICT services or ICT processes that do not meet cybersecurity standards, while importers and distributors should make sure that the ICT products, ICT services and ICT processes they place on the Union market comply with the applicable requirements and do not present a risk to Union consumers. (51) In cooperation with competent authorities, ENISA should be able to disseminate information regarding the level of the cybersecurity of the ICT products, ICT services and ICT processes offered in the internal market, and should issue warnings targeting manufacturers or providers of ICT products, ICT services or ICT processes and requiring them to improve the security of their ICT products, ICT services and ICT processes, including the cybersecurity. (52) ENISA should take full account of the ongoing research, development and technological assessment activities, in particular those activities carried out by the various Union research initiatives to advise Union institutions, bodies, offices and agencies and where relevant, the Member States at their request, on research needs and priorities in the field of cybersecurity. In order to identify the research needs and priorities, ENISA should also consult the relevant user groups. More specifically, cooperation with the European Research Council, the European Institute for Innovation and Technology and the European Union Institute for Security Studies could be established. (53) ENISA should regularly consult standardisation organisations, in particular European standardisation organisations, when preparing the European cybersecurity certification schemes. (54) Cyber threats are a global issue. There is a need for closer international cooperation to improve cybersecurity standards, including the need for definitions of common norms of behaviour, the adoption of codes of conduct, the use of international standards, and information sharing, promoting swifter international collaboration in response to network and information security issues and promoting a common global approach to such issues. To that end, ENISA should support further Union involvement and cooperation with third countries and international organisations by providing the necessary expertise and analysis to the relevant Union institutions, bodies, offices and agencies, where appropriate. (55) ENISA should be able to respond to ad hoc requests for advice and assistance by Member States and Union institutions, bodies, offices and agencies on matters falling within ENISA\u2019s mandate. (56) It is sensible and recommended to implement certain principles regarding the governance of ENISA in order to comply with the Joint Statement and Common Approach agreed upon in July 2012 by the Inter-Institutional Working Group on EU decentralised agencies, the purpose of which is to streamline the activities of decentralised agencies and improve their performance. The recommendations in the Joint Statement and Common Approach should also be reflected, as appropriate, in ENISA\u2019s work programmes, evaluations of ENISA, and ENISA\u2019s reporting and administrative practice. (57) The Management Board, composed of the representatives of the Member States and of the Commission, should establish the general direction of ENISA\u2019s operations and ensure that it carries out its tasks in accordance with this Regulation. The Management Board should be entrusted with the powers necessary to establish the budget, verify the execution of the budget, adopt appropriate financial rules, establish transparent working procedures for decision making by ENISA, adopt ENISA\u2019s single programming document, adopt its own rules of procedure, appoint the Executive Director and decide on the extension and termination of the Executive Director\u2019s term of office. (58) In order for ENISA to function properly and effectively, the Commission and the Member States should ensure that persons to be appointed to the Management Board have appropriate professional expertise and experience. The Commission and the Member States should also make efforts to limit the turnover of their respective representatives on the Management Board in order to ensure continuity in its work. (59) The smooth functioning of ENISA requires that its Executive Director be appointed on grounds of merit and documented administrative and managerial skills, as well as competence and experience relevant to cybersecurity. The duties of the Executive Director should be carried out with complete independence. The Executive Director should prepare a proposal for ENISA\u2019s annual work programme, after prior consultation with the Commission, and should take all steps necessary to ensure the proper implementation of that work programme. The Executive Director should prepare an annual report to be submitted to the Management Board, covering the implementation of ENISA\u2019s annual work programme, draw up a draft statement of estimates of revenue and expenditure for ENISA, and implement the budget. Furthermore, the Executive Director should have the option of setting up ad hoc working groups to address specific matters, in particular matters of a scientific, technical, legal or socioeconomic nature. In particular, in relation to the preparation of a specific candidate European cybersecurity certification scheme (\u2018candidate scheme\u2019), the setting up of an ad hoc working group is considered to be necessary. The Executive Director should ensure that the members of ad hoc working groups are selected according to the highest standards of expertise, aiming to ensure gender balance and an appropriate balance, according to the specific issues in question, between the public administrations of the Member States, the Union institutions, bodies, offices and agencies and the private sector, including industry, users, and academic experts in network and information security. (60) The Executive Board should contribute to the effective functioning of the Management Board. As part of its preparatory work related to Management Board decisions, the Executive Board should examine relevant information in detail, explore available options and offer advice and solutions to prepare the decisions of the Management Board. (61) ENISA should have an ENISA Advisory Group as an advisory body to ensure regular dialogue with the private sector, consumers\u2019 organisations and other relevant stakeholders. The ENISA Advisory Group, established by the Management Board on a proposal from the Executive Director, should focus on issues relevant to stakeholders and should bring them to the attention of ENISA. The ENISA Advisory Group should be consulted in particular with regard to ENISA\u2019s draft annual work programme. The composition of the ENISA Advisory Group and the tasks assigned to it should ensure sufficient representation of stakeholders in the work of ENISA. (62) The Stakeholder Cybersecurity Certification Group should be established in order to help ENISA and the Commission facilitate the consultation of relevant stakeholders. The Stakeholder Cybersecurity Certification Group should be composed of members representing industry in balanced proportions, both on the demand side and the supply side of ICT products and ICT services, and including, in particular, SMEs, digital service providers, European and international standardisation bodies, national accreditation bodies, data protection supervisory authorities and conformity assessment bodies pursuant to Regulation (EC) No 765/2008 of the European Parliament and of the Council (16), and academia as well as consumer organisations. (63) ENISA should have rules in place regarding the prevention and the management of conflicts of interest. ENISA should also apply the relevant Union provisions concerning public access to documents as set out in Regulation (EC) No 1049/2001 of the European Parliament and of the Council (17). The processing of personal data by ENISA should be subject to Regulation (EU) 2018/1725 of the European Parliament and of the Council (18). ENISA should comply with the provisions applicable to the Union institutions, bodies, offices and agencies, and with national legislation regarding the handling of information, in particular sensitive non-classified information and European Union classified information (EUCI). (64) In order to guarantee the full autonomy and independence of ENISA and to enable it to perform additional tasks, including unforeseen emergency tasks, ENISA should be granted a sufficient and autonomous budget whose revenue should primarily come from a contribution from the Union and contributions from third countries participating in ENISA\u2019s work. An appropriate budget is paramount for ensuring that ENISA has sufficient capacity to perform all of its growing tasks and to achieve its objectives. The majority of ENISA\u2019s staff should be directly engaged in the operational implementation of ENISA\u2019s mandate. The host Member State, and any other Member State, should be allowed to make voluntary contributions to ENISA\u2019s budget. The Union\u2019s budgetary procedure should remain applicable as far as any subsidies chargeable to the general budget of the Union are concerned. Moreover, the Court of Auditors should audit ENISA\u2019s accounts to ensure transparency and accountability. (65) Cybersecurity certification plays an important role in increasing trust and security in ICT products, ICT services and ICT processes. The digital single market, and in particular the data economy and the IoT, can thrive only if there is general public trust that such products, services and processes provide a certain level of cybersecurity. Connected and automated cars, electronic medical devices, industrial automation control systems and smart grids are only some examples of sectors in which certification is already widely used or is likely to be used in the near future. The sectors regulated by Directive (EU) 2016/1148 are also sectors in which cybersecurity certification is critical. (66) In the 2016 Communication \u2018Strengthening Europe\u2019s Cyber Resilience System and Fostering a Competitive and Innovative Cybersecurity Industry\u2019, the Commission outlined the need for high-quality, affordable and interoperable cybersecurity products and solutions. The supply of ICT products, ICT services and ICT processes within the single market remains very fragmented geographically. This is because the cybersecurity industry in Europe has developed largely on the basis of national governmental demand. In addition, the lack of interoperable solutions (technical standards), practices and Union-wide mechanisms of certification are among the other gaps affecting the single market in the field of cybersecurity. This makes it difficult for European businesses to compete at national, Union and global level. It also reduces the choice of viable and usable cybersecurity technologies that individuals and businesses have access to. Similarly, in the 2017 Communication on the Mid-Term Review on the implementation of the Digital Single Market Strategy \u2013 A Connected Digital Single Market for All, the Commission highlighted the need for safe connected products and systems, and indicated that the creation of a European ICT security framework setting rules on how to organise ICT security certification in the Union could both preserve trust in the internet and tackle the current fragmentation of the internal market. (67) Currently, the cybersecurity certification of ICT products, ICT services and ICT processes is used only to a limited extent. When it exists, it mostly occurs at Member State level or in the framework of industry driven schemes. In that context, a certificate issued by a national cybersecurity certification authority is not in principle recognised in other Member States. Companies thus may have to certify their ICT products, ICT services and ICT processes in several Member States where they operate, for example, with a view to participating in national procurement procedures, which thereby adds to their costs. Moreover, while new schemes are emerging, there seems to be no coherent and holistic approach to horizontal cybersecurity issues, for instance in the field of the IoT. Existing schemes present significant shortcomings and differences in terms of product coverage, levels of assurance, substantive criteria and actual use, impeding mutual recognition mechanisms within the Union. (68) Some efforts have been made in order to ensure the mutual recognition of certificates within the Union. However, they have been only partly successful. The most important example in this regard is the Senior Officials Group \u2013 Information Systems Security (SOG-IS) Mutual Recognition Agreement (MRA). While it represents the most important model for cooperation and mutual recognition in the field of security certification, SOG-IS includes only some of the Member States. That fact has limited the effectiveness of SOG-IS MRA from the point of view of the internal market. (69) Therefore, it is necessary to adopt a common approach and to establish a European cybersecurity certification framework that lays down the main horizontal requirements for European cybersecurity certification schemes to be developed and allows European cybersecurity certificates and EU statements of conformity for ICT products, ICT services or ICT processes to be recognised and used in all Member States. In doing so, it is essential to build on existing national and international schemes, as well as on mutual recognition systems, in particular SOG-IS, and to make possible a smooth transition from the existing schemes under such systems to schemes under the new European cybersecurity certification framework. The European cybersecurity certification framework should have a twofold purpose. First, it should help increase trust in ICT products, ICT services and ICT processes that have been certified under European cybersecurity certification schemes. Second, it should help avoid the multiplication of conflicting or overlapping national cybersecurity certification schemes and thus reduce costs for undertakings operating in the digital single market. The European cybersecurity certification schemes should be non-discriminatory and based on European or international standards, unless those standards are ineffective or inappropriate to fulfil the Union\u2019s legitimate objectives in that regard. (70) The European cybersecurity certification framework should be established in a uniform manner in all Member States in order to prevent \u2018certification shopping\u2019 based on different levels of stringency in different Member States. (71) European cybersecurity certification schemes should be built on what already exists at international and national level and, if necessary, on technical specifications from forums and consortia, learning from current strong points and assessing and correcting weaknesses. (72) Flexible cybersecurity solutions are necessary for the industry to stay ahead of cyber threats, and therefore any certification scheme should be designed in a way that avoids the risk of being outdated quickly. (73) The Commission should be empowered to adopt European cybersecurity certification schemes concerning specific groups of ICT products, ICT services and ICT processes. Those schemes should be implemented and supervised by national cybersecurity certification authorities, and certificates issued under those schemes should be valid and recognised throughout the Union. Certification schemes operated by the industry or by other private organisations should fall outside of the scope of this Regulation. However, the bodies operating such schemes should be able to propose that the Commission consider such schemes as a basis for approving them as a European cybersecurity certification scheme. (74) The provisions of this Regulation should be without prejudice to Union law providing specific rules on the certification of ICT products, ICT services and ICT processes. In particular, Regulation (EU) 2016/679 lays down provisions for the establishment of certification mechanisms and of data protection seals and marks, for the purpose of demonstrating the compliance of processing operations by controllers and processors with that Regulation. Such certification mechanisms and data protection seals and marks should allow data subjects to quickly assess the level of data protection of the relevant ICT products, ICT services and ICT processes. This Regulation is without prejudice to the certification of data processing operations under Regulation (EU) 2016/679, including when such operations are embedded in ICT products, ICT services and ICT processes. (75) The purpose of European cybersecurity certification schemes should be to ensure that ICT products, ICT services and ICT processes certified under such schemes comply with specified requirements that aim to protect the availability, authenticity, integrity and confidentiality of stored, transmitted or processed data or of the related functions of or services offered by, or accessible via those products, services and processes throughout their life cycle. It is not possible to set out in detail the cybersecurity requirements relating to all ICT products, ICT services and ICT processes in this Regulation. ICT products, ICT services and ICT processes and the cybersecurity needs related to those products, services and processes are so diverse that it is very difficult to develop general cybersecurity requirements that are valid in all circumstances. It is therefore necessary to adopt a broad and general notion of cybersecurity for the purpose of certification, which should be complemented by a set of specific cybersecurity objectives that are to be taken into account when designing European cybersecurity certification schemes. The arrangements by which such objectives are to be achieved in specific ICT products, ICT services and ICT processes should then be further specified in detail at the level of the individual certification scheme adopted by the Commission, for example by reference to standards or technical specifications if no appropriate standards are available. (76) The technical specifications to be used in European cybersecurity certification schemes should respect the requirements set out in Annex II to Regulation (EU) No 1025/2012 of the European Parliament and of the Council (19). Some deviations from those requirements could, however, be considered to be necessary in duly justified cases where those technical specifications are to be used in a European cybersecurity certification scheme referring to assurance level \u2018high\u2019. The reasons for such deviations should be made publicly available. (77) A conformity assessment is a procedure for evaluating whether specified requirements relating to an ICT product, ICT service or ICT process have been fulfilled. That procedure is carried out by an independent third party that is not the manufacturer or provider of the ICT products, ICT services or ICT processes that are being assessed. A European cybersecurity certificate should be issued following the successful evaluation of an ICT product, ICT service or ICT process. A European cybersecurity certificate should be considered to be a confirmation that the evaluation has been properly carried out. Depending on the assurance level, the European cybersecurity certification scheme should indicate whether the European cybersecurity certificate is to be issued by a private or public body. Conformity assessment and certification cannot guarantee per se that certified ICT products, ICT services and ICT processes are cyber secure. They are instead procedures and technical methodologies for attesting that ICT products, ICT services and ICT processes have been tested and that they comply with certain cybersecurity requirements laid down elsewhere, for example in technical standards. (78) The choice of the appropriate certification and associated security requirements by the users of European cybersecurity certificates should be based on an analysis of the risks associated with the use of the ICT products, ICT services or ICT processes. Accordingly, the assurance level should be commensurate with the level of the risk associated with the intended use of an ICT product, ICT service or ICT process. (79) European cybersecurity certification schemes could provide for a conformity assessment to be carried out under the sole responsibility of the manufacturer or provider of ICT products, ICT services or ICT processes (\u2018conformity self-assessment\u2019). In such cases, it should be sufficient that the manufacturer or provider of ICT products, ICT services or ICT processes itself carry out all of the checks to ensure that the ICT products, ICT services or ICT processes conform with the European cybersecurity certification scheme. Conformity self-assessment should be considered to be appropriate for low complexity ICT products, ICT services or ICT processes that present a low risk to the public, such as simple design and production mechanisms. Moreover, conformity self-assessment should be permitted for ICT products, ICT services or ICT processes only where they correspond to assurance level \u2018basic\u2019. (80) European cybersecurity certification schemes could allow for both conformity self-assessments and certifications of ICT products, ICT services or ICT processes. In such a case, the scheme should provide for clear and understandable means for consumers or other users to differentiate between ICT products, ICT services or ICT processes with regard to which the manufacturer or provider of ICT products, ICT services or ICT processes is responsible for the assessment, and ICT products, ICT services or ICT processes that are certified by a third party. (81) The manufacturer or provider of ICT products, ICT services or ICT processes who carry out a conformity self-assessment should be able to issue and sign the EU statement of conformity as part of the conformity assessment procedure. An EU statement of conformity is a document that states that a specific ICT product, ICT service or ICT process complies with the requirements of the European cybersecurity certification scheme. By issuing and signing the EU statement of conformity, the manufacturer or provider of ICT products, ICT services or ICT processes assumes responsibility for the compliance of the ICT product, ICT service or ICT process with the legal requirements of the European cybersecurity certification scheme. A copy of the EU statement of conformity should be submitted to the national cybersecurity certification authority and to ENISA. (82) Manufacturers or providers of ICT products, ICT services or ICT processes should make the EU statement of conformity, technical documentation, and all other relevant information relating to the conformity of the ICT products, ICT services or ICT processes with a European cybersecurity certification scheme available to the competent national cybersecurity certification authority for a period provided for in the relevant European cybersecurity certification scheme. The technical documentation should specify the requirements applicable under the scheme and should cover the design, manufacture and operation of the ICT product, ICT service or ICT process to the extent relevant to the conformity self-assessment. The technical documentation should be so compiled as to enable the assessment of whether an ICT product or ICT service complies with the requirements applicable under that scheme. (83) The governance of the European cybersecurity certification framework takes into account the involvement of Member States as well as the appropriate involvement of stakeholders, and establishes the role of the Commission during the planning and proposing, requesting, preparing, adopting and reviewing of European cybersecurity certification schemes. (84) The Commission should prepare, with the support of the European Cybersecurity Certification Group (the \u2018ECCG\u2019) and the Stakeholder Cybersecurity Certification Group and after an open and wide consultation, a Union rolling work programme for European cybersecurity certification schemes and should publish it in the form of a non-binding instrument. The Union rolling work programme should be a strategic document that allows industry, national authorities and standardisation bodies, in particular, to prepare in advance for future European cybersecurity certification schemes. The Union rolling work programme should include a multiannual overview of the requests for candidate schemes which the Commission intends to submit to ENISA for preparation on the basis of specific grounds. The Commission should take into account the Union rolling work programme while preparing its Rolling Plan for ICT Standardisation and standardisation requests to European standardisation organisations. In light of the rapid introduction and uptake of new technologies, the emergence of previously unknown cybersecurity risks, and legislative and market developments, the Commission or the ECCG should be entitled to request ENISA to prepare candidate schemes which have not been included in the Union rolling work programme. In such cases, the Commission and the ECCG should also assess the necessity of such a request, taking into account the overall aims and objectives of this Regulation and the need to ensure continuity as regards ENISA\u2019s planning and use of resources. Following such a request, ENISA should prepare the candidate schemes for specific ICT products, ICT services and ICT processes without undue delay. The Commission should evaluate the positive and negative impact of its request on the specific market in question, especially its impact on SMEs, on innovation, on barriers to entry to that market and on costs to end users. The Commission, on the basis of the candidate scheme prepared by ENISA, should be empowered to adopt the European cybersecurity certification scheme by means of implementing acts. Taking account of the general purpose and security objectives laid down in this Regulation, European cybersecurity certification schemes adopted by the Commission should specify a minimum set of elements concerning the subject matter, scope and functioning of the individual scheme. Those elements should include, among other things, the scope and object of the cybersecurity certification, including the categories of ICT products, ICT services and ICT processes covered, the detailed specification of the cybersecurity requirements, for example by reference to standards or technical specifications, the specific evaluation criteria and evaluation methods, as well as the intended assurance level (\u2018basic\u2019, \u2018substantial\u2019 or \u2018high\u2019) and the evaluation levels where applicable. ENISA should be able to refuse a request by the ECCG. Such decisions should be taken by the Management Board and should be duly reasoned. (85) ENISA should maintain a website providing information on and publicising European cybersecurity certification schemes, which should include, among other things, the requests for the preparation of a candidate scheme as well as the feedback received in the consultation process carried out by ENISA in the preparation phase. The website should also provide information about the European cybersecurity certificates and EU statements of conformity issued under this Regulation including information regarding the withdrawal and expiry of such European cybersecurity certificates and EU statements of conformity. The website should also indicate the national cybersecurity certification schemes that have been replaced by a European cybersecurity certification scheme. (86) The assurance level of a European certification scheme is a basis for confidence that an ICT product, ICT service or ICT process meets the security requirements of a specific European cybersecurity certification scheme. In order to ensure the consistency of the European cybersecurity certification framework, a European cybersecurity certification scheme should be able to specify assurance levels for European cybersecurity certificates and EU statements of conformity issued under that scheme. Each European cybersecurity certificate might refer to one of the assurance levels: \u2018basic\u2019, \u2018substantial\u2019 or \u2018high\u2019, while the EU statement of conformity might only refer to the assurance level \u2018basic\u2019. The assurance levels would provide the corresponding rigour and depth of the evaluation of the ICT product, ICT service or ICT process and would be characterised by reference to technical specifications, standards and procedures related thereto, including technical controls, the purpose of which is to mitigate or prevent incidents. Each assurance level should be consistent among the different sectorial domains where certification is applied. (87) A European cybersecurity certification scheme might specify several evaluation levels depending on the rigour and depth of the evaluation methodology used. Evaluation levels should correspond to one of the assurance levels and should be associated with an appropriate combination of assurance components. For all assurance levels, the ICT product, ICT service or ICT process should contain a number of secure functions, as specified by the scheme, which may include: a secure out-of-the-box configuration, a signed code, secure update and exploit mitigations and full stack or heap memory protections. Those functions should have been developed, and be maintained, using security-focused development approaches and associated tools to ensure that effective software and hardware mechanisms are reliably incorporated. (88) For assurance level \u2018basic\u2019, the evaluation should be guided at least by the following assurance components: the evaluation should at least include a review of the technical documentation of the ICT product, ICT service or ICT process by the conformity assessment body. Where the certification includes ICT processes, the process used to design, develop and maintain an ICT product or ICT service should also be subject to the technical review. Where a European cybersecurity certification scheme provides for a conformity self-assessment, it should be sufficient that the manufacturer or provider of ICT products, ICT services or ICT processes has carried out a self-assessment of the compliance of the ICT product, ICT service or ICT process with the certification scheme. (89) For assurance level \u2018substantial\u2019, the evaluation, in addition to the requirements for assurance level \u2018basic\u2019, should be guided at least by the verification of the compliance of the security functionalities of the ICT product, ICT service or ICT process with its technical documentation. (90) For assurance level \u2018high\u2019, the evaluation, in addition to the requirements for assurance level \u2018substantial\u2019, should be guided at least by an efficiency testing which assesses the resistance of the security functionalities of ICT product, ICT service or ICT process against elaborate cyberattacks performed by persons who have significant skills and resources. (91) Recourse to European cybersecurity certification and to EU statements of conformity should remain voluntary, unless otherwise provided for in Union law, or in Member State law adopted in accordance with Union law. In the absence of harmonised Union law, Member States are able to adopt national technical regulations providing for mandatory certification under a European cybersecurity certification scheme in accordance with Directive (EU) 2015/1535 of the European Parliament and of the Council (20). Member States also have recourse to European cybersecurity certification in the context of public procurement and of Directive 2014/24/EU of the European Parliament and of the Council (21). (92) In some areas, it could be necessary in the future to impose specific cybersecurity requirements and make the certification thereof mandatory for certain ICT products, ICT services or ICT processes, in order to improve the level of cybersecurity in the Union. The Commission should regularly monitor the impact of adopted European cybersecurity certification schemes on the availability of secure ICT products, ICT services and ICT processes in the internal market and should regularly assess the level of use of the certification schemes by the manufacturers or providers of ICT products, ICT services or ICT processes in the Union. The efficiency of the European cybersecurity certification schemes, and whether specific schemes should be made mandatory, should be assessed in light of the cybersecurity-related legislation of the Union, in particular Directive (EU) 2016/1148, taking into consideration the security of the network and information systems used by operators of essential services. (93) European cybersecurity certificates and EU statements of conformity should help end users to make informed choices. Therefore, ICT products, ICT services and ICT processes that have been certified or for which an EU statement of conformity has been issued should be accompanied by structured information that is adapted to the expected technical level of the intended end user. All such information should be available online, and, where appropriate, in physical form. The end user should have access to information regarding the reference number of the certification scheme, the assurance level, the description of the cybersecurity risks associated with the ICT product, ICT service or ICT process, and the issuing authority or body, or should be able to obtain a copy of the European cybersecurity certificate. In addition, the end user should be informed of the cybersecurity support policy, namely for how long the end user can expect to receive cybersecurity updates or patches, of the manufacturer or provider of ICT products, ICT services or ICT processes. Where applicable, guidance on actions or settings that the end user can implement to maintain or increase the cybersecurity of the ICT product or of the ICT service and contact information of a single point of contact to report and receive support in the case of cyberattacks (in addition to automatic reporting) should be provided. That information should be regularly updated and made available on a website providing information on European cybersecurity certification schemes. (94) With a view to achieving the objectives of this Regulation and avoiding the fragmentation of the internal market, national cybersecurity certification schemes or procedures for ICT products, ICT services or ICT processes covered by a European cybersecurity certification scheme should cease to be effective from a date established by the Commission by means of implementing acts. Moreover, Member States should not introduce new national cybersecurity certification schemes for ICT products, ICT services or ICT processes already covered by an existing European cybersecurity certification scheme. However, Member States should not be prevented from adopting or maintaining national cybersecurity certification schemes for national security purposes. Member States should inform the Commission and the ECCG of any intention to draw up new national cybersecurity certification schemes. The Commission and the ECCG should evaluate the impact of the new national cybersecurity certification schemes on the proper functioning of the internal market and in light of any strategic interest in requesting a European cybersecurity certification scheme instead. (95) European cybersecurity certification schemes are intended to help harmonise cybersecurity practices within the Union. They need to contribute to increasing the level of cybersecurity within the Union. The design of the European cybersecurity certification schemes should take into account and allow for the development of innovations in the field of cybersecurity. (96) European cybersecurity certification schemes should take into account current software and hardware development methods and, in particular, the impact of frequent software or firmware updates on individual European cybersecurity certificates. European cybersecurity certification schemes should specify the conditions under which an update may require that an ICT product, ICT service or ICT process be recertified or that the scope of a specific European cybersecurity certificate be reduced, taking into account any possible adverse effects of the update on compliance with the security requirements of that certificate. (97) Once a European cybersecurity certification scheme is adopted, manufacturers or providers of ICT products, ICT services or ICT processes should be able to submit applications for certification of their ICT products or ICT services to the conformity assessment body of their choice anywhere in the Union. Conformity assessment bodies should be accredited by a national accreditation body if they comply with certain specified requirements set out in this Regulation. Accreditation should be issued for a maximum of five years and should be renewable on the same conditions provided that the conformity assessment body still meets the requirements. National accreditation bodies should restrict, suspend or revoke the accreditation of a conformity assessment body where the conditions for the accreditation have not been met or are no longer met, or where the conformity assessment body infringes this Regulation. (98) References in national legislation to national standards which have ceased to be effective due to the entry into force of a European cybersecurity certification scheme can be a source of confusion. Therefore, Member States should reflect the adoption of a European cybersecurity certification scheme in their national legislation. (99) In order to achieve equivalent standards throughout the Union, to facilitate mutual recognition and to promote the overall acceptance of European cybersecurity certificates and EU statements of conformity, it is necessary to put in place a system of peer review between national cybersecurity certification authorities. Peer review should cover procedures for supervising the compliance of ICT products, ICT services and ICT processes with European cybersecurity certificates, for monitoring the obligations of manufacturers or providers of ICT products, ICT services or ICT processes who carry out the conformity self-assessment, for monitoring conformity assessment bodies, as well as the appropriateness of the expertise of the staff of bodies issuing certificates for assurance level \u2018high\u2019. The Commission should be able, by means of implementing acts, to establish at least a five-year plan for peer reviews, as well as lay down criteria and methodologies for the operation of the peer review system. (100) Without prejudice to the general peer review system to be put in place across all national cybersecurity certification authorities within the European cybersecurity certification framework, certain European cybersecurity certification schemes may include a peer-assessment mechanism for the bodies that issue European cybersecurity certificates for ICT products, ICT services and ICT processes with an assurance level \u2018high\u2019 under such schemes. The ECCG should support the implementation of such peer-assessment mechanisms. The peer assessments should assess in particular whether the bodies concerned carry out their tasks in a harmonised way, and may include appeal mechanisms. The results of the peer assessments should be made publicly available. The bodies concerned may adopt appropriate measures to adapt their practices and expertise accordingly. (101) Member States should designate one or more national cybersecurity certification authorities to supervise compliance with obligations arising from this Regulation. A national cybersecurity certification authority may be an existing or new authority. A Member State should also be able to designate, after agreeing with another Member State, one or more national cybersecurity certification authorities in the territory of that other Member State. (102) National cybersecurity certification authorities should in particular monitor and enforce the obligations of manufacturers or providers of ICT products, ICT services or ICT processes established in its respective territory in relation to the EU statement of conformity, should assist the national accreditation bodies in the monitoring and supervision of the activities of conformity assessment bodies by providing them with expertise and relevant information, should authorise conformity assessment bodies to carry out their tasks where such bodies meet additional requirements set out in a European cybersecurity certification scheme, and should monitor relevant developments in the field of cybersecurity certification. National cybersecurity certification authorities should also handle complaints lodged by natural or legal persons in relation to European cybersecurity certificates issued by those authorities or in relation to European cybersecurity certificates issued by conformity assessment bodies, where such certificates indicate assurance level \u2018high\u2019, should investigate, to the extent appropriate, the subject matter of the complaint and should inform the complainant of the progress and the outcome of the investigation within a reasonable period. Moreover, national cybersecurity certification authorities should cooperate with other national cybersecurity certification authorities or other public authorities, including by the sharing of information on the possible non-compliance of ICT products, ICT services and ICT processes with the requirements of this Regulation or with specific European cybersecurity certification schemes. The Commission should facilitate that sharing of information by making available a general electronic information support system, for example the Information and Communication System on Market Surveillance (ICSMS) and the Rapid Alert System for dangerous non-food products (RAPEX), already used by market surveillance authorities pursuant to Regulation (EC) No 765/2008. (103) With a view to ensuring the consistent application of the European cybersecurity certification framework, an ECCG that consists of representatives of national cybersecurity certification authorities or other relevant national authorities should be established. The main tasks of the ECCG should be to advise and assist the Commission in its work towards ensuring the consistent implementation and application of the European cybersecurity certification framework, to assist and closely cooperate with ENISA in the preparation of candidate cybersecurity certification schemes, in duly justified cases to request ENISA to prepare a candidate scheme, to adopt opinions addressed to ENISA on candidate schemes and to adopt opinions addressed to the Commission on the maintenance and review of existing European cybersecurity certifications schemes. The ECCG should facilitate the exchange of good practices and expertise between the various national cybersecurity certification authorities that are responsible for the authorisation of conformity assessment bodies and the issuance of European cybersecurity certificates. (104) In order to raise awareness and to facilitate the acceptance of future European cybersecurity certification schemes, the Commission may issue general or sector-specific cybersecurity guidelines, for example on good cybersecurity practices or responsible cybersecurity behaviour highlighting the positive effect of the use of certified ICT products, ICT services and ICT processes. (105) In order to further facilitate trade, and recognising that ICT supply chains are global, mutual recognition agreements concerning European cybersecurity certificates may be concluded by the Union in accordance with Article 218 of the Treaty on the Functioning of the European Union (TFEU). The Commission, taking into account the advice from ENISA and the European Cybersecurity Certification Group, may recommend the opening of relevant negotiations. Each European cybersecurity certification scheme should provide specific conditions for such mutual recognition agreements with third countries. (106) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (22). (107) The examination procedure should be used for the adoption of implementing acts on European cybersecurity certification schemes for ICT products, ICT services or ICT processes, for the adoption of implementing acts on arrangements for carrying out inquiries by ENISA, for the adoption of implementing acts on a plan for the peer review of national cybersecurity certification authorities, as well as for the adoption of implementing acts on the circumstances, formats and procedures of notifications of accredited conformity assessment bodies by the national cybersecurity certification authorities to the Commission. (108) ENISA\u2019s operations should be subject to regular and independent evaluation. That evaluation should have regard to ENISA\u2019s objectives, its working practices and the relevance of its tasks, in particular its tasks relating to the operational cooperation at Union level. That evaluation should also assess the impact, effectiveness and efficiency of the European cybersecurity certification framework. In the event of a review, the Commission should evaluate how ENISA\u2019s role as a reference point for advice and expertise can be reinforced and should also evaluate the possibility of a role for ENISA in supporting the assessment of third country ICT products, ICT services and ICT processes that do not comply with Union rules, where such products, services and processes enter the Union. (109) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (110) Regulation (EU) No 526/2013 should be repealed, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter and scope 1. With a view to ensuring the proper functioning of the internal market while aiming to achieve a high level of cybersecurity, cyber resilience and trust within the Union, this Regulation lays down: (a) objectives, tasks and organisational matters relating to ENISA (the European Union Agency for Cybersecurity); and (b) a framework for the establishment of European cybersecurity certification schemes for the purpose of ensuring an adequate level of cybersecurity for ICT products, ICT services and ICT processes in the Union, as well as for the purpose of avoiding the fragmentation of the internal market with regard to cybersecurity certification schemes in the Union. The framework referred to in point (b) of the first subparagraph applies without prejudice to specific provisions in other Union legal acts regarding voluntary or mandatory certification. 2. This Regulation is without prejudice to the competences of the Member States regarding activities concerning public security, defence, national security and the activities of the State in areas of criminal law. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018cybersecurity\u2019 means the activities necessary to protect network and information systems, the users of such systems, and other persons affected by cyber threats; (2) \u2018network and information system\u2019 means a network and information system as defined in point (1) of Article 4 of Directive (EU) 2016/1148; (3) \u2018national strategy on the security of network and information systems\u2019 means a national strategy on the security of network and information systems as defined in point (3) of Article 4 of Directive (EU) 2016/1148; (4) \u2018operator of essential services\u2019 means an operator of essential services as defined in point (4) of Article 4 of Directive (EU) 2016/1148; (5) \u2018digital service provider\u2019 means a digital service provider as defined in point (6) of Article 4 of Directive (EU) 2016/1148; (6) \u2018incident\u2019 means an incident as defined in point (7) of Article 4 of Directive (EU) 2016/1148; (7) \u2018incident handling\u2019 means incident handling as defined in point (8) of Article 4 of Directive (EU) 2016/1148; (8) \u2018cyber threat\u2019 means any potential circumstance, event or action that could damage, disrupt or otherwise adversely impact network and information systems, the users of such systems and other persons; (9) \u2018European cybersecurity certification scheme\u2019 means a comprehensive set of rules, technical requirements, standards and procedures that are established at Union level and that apply to the certification or conformity assessment of specific ICT products, ICT services or ICT processes; (10) \u2018national cybersecurity certification scheme\u2019 means a comprehensive set of rules, technical requirements, standards and procedures developed and adopted by a national public authority and that apply to the certification or conformity assessment of ICT products, ICT services and ICT processes falling under the scope of the specific scheme; (11) \u2018European cybersecurity certificate\u2019 means a document issued by a relevant body, attesting that a given ICT product, ICT service or ICT process has been evaluated for compliance with specific security requirements laid down in a European cybersecurity certification scheme; (12) \u2018ICT product\u2019 means an element or a group of elements of a network or information system; (13) \u2018ICT service\u2019 means a service consisting fully or mainly in the transmission, storing, retrieving or processing of information by means of network and information systems; (14) \u2018ICT process\u2019 means a set of activities performed to design, develop, deliver or maintain an ICT product or ICT service; (15) \u2018accreditation\u2019 means accreditation as defined in point (10) of Article 2 of Regulation (EC) No 765/2008; (16) \u2018national accreditation body\u2019 means a national accreditation body as defined in point (11) of Article 2 of Regulation (EC) No 765/2008; (17) \u2018conformity assessment\u2019 means a conformity assessment as defined in point (12) of Article 2 of Regulation (EC) No 765/2008; (18) \u2018conformity assessment body\u2019 means a conformity assessment body as defined in point (13) of Article 2 of Regulation (EC) No 765/2008; (19) \u2018standard\u2019 means a standard as defined in point (1) of Article 2 of Regulation (EU) No 1025/2012; (20) \u2018technical specification\u2019 means a document that prescribes the technical requirements to be met by, or conformity assessment procedures relating to, an ICT product, ICT service or ICT process; (21) \u2018assurance level\u2019 means a basis for confidence that an ICT product, ICT service or ICT process meets the security requirements of a specific European cybersecurity certification scheme, indicates the level at which an ICT product, ICT service or ICT process has been evaluated but as such does not measure the security of the ICT product, ICT service or ICT process concerned; (22) \u2018conformity self-assessment\u2019 means an action carried out by a manufacturer or provider of ICT products, ICT services or ICT processes, which evaluates whether those ICT products, ICT services or ICT processes meet the requirements of a specific European cybersecurity certification scheme. TITLE II ENISA (THE EUROPEAN UNION AGENCY FOR CYBERSECURITY) CHAPTER I Mandate and objectives Article 3 Mandate 1. ENISA shall carry out the tasks assigned to it under this Regulation for the purpose of achieving a high common level of cybersecurity across the Union, including by actively supporting Member States, Union institutions, bodies, offices and agencies in improving cybersecurity. ENISA shall act as a reference point for advice and expertise on cybersecurity for Union institutions, bodies, offices and agencies as well as for other relevant Union stakeholders. ENISA shall contribute to reducing the fragmentation of the internal market by carrying out the tasks assigned to it under this Regulation. 2. ENISA shall carry out the tasks assigned to it by Union legal acts that set out measures for approximating Member State laws, regulations and administrative provisions which are related to cybersecurity. 3. When carrying out its tasks, ENISA shall act independently while avoiding the duplication of Member State activities and taking into consideration existing Member State expertise. 4. ENISA shall develop its own resources, including technical and human capabilities and skills, necessary to perform the tasks assigned to it under this Regulation. Article 4 Objectives 1. ENISA shall be a centre of expertise on cybersecurity by virtue of its independence, the scientific and technical quality of the advice and assistance it delivers, the information it provides, the transparency of its operating procedures, the methods of operation, and its diligence in carrying out its tasks. 2. ENISA shall assist the Union institutions, bodies, offices and agencies, as well as Member States, in developing and implementing Union policies related to cybersecurity, including sectoral policies on cybersecurity. 3. ENISA shall support capacity-building and preparedness across the Union by assisting the Union institutions, bodies, offices and agencies, as well as Member States and public and private stakeholders, to increase the protection of their network and information systems, to develop and improve cyber resilience and response capacities, and to develop skills and competencies in the field of cybersecurity. 4. ENISA shall promote cooperation, including information sharing and coordination at Union level, among Member States, Union institutions, bodies, offices and agencies, and relevant private and public stakeholders on matters related to cybersecurity. 5. ENISA shall contribute to increasing cybersecurity capabilities at Union level in order to support the actions of Member States in preventing and responding to cyber threats, in particular in the event of cross-border incidents. 6. ENISA shall promote the use of European cybersecurity certification, with a view to avoiding the fragmentation of the internal market. ENISA shall contribute to the establishment and maintenance of a European cybersecurity certification framework in accordance with Title III of this Regulation, with a view to increasing the transparency of the cybersecurity of ICT products, ICT services and ICT processes, thereby strengthening trust in the digital internal market and its competitiveness. 7. ENISA shall promote a high level of cybersecurity awareness, including cyber-hygiene and cyber-literacy among citizens, organisations and businesses. CHAPTER II Tasks Article 5 Development and implementation of Union policy and law ENISA shall contribute to the development and implementation of Union policy and law, by: (1) assisting and advising on the development and review of Union policy and law in the field of cybersecurity and on sector-specific policy and law initiatives where matters related to cybersecurity are involved, in particular by providing its independent opinion and analysis as well as carrying out preparatory work; (2) assisting Member States to implement the Union policy and law regarding cybersecurity consistently, in particular in relation to Directive (EU) 2016/1148, including by means of issuing opinions, guidelines, providing advice and best practices on topics such as risk management, incident reporting and information sharing, as well as by facilitating the exchange of best practices between competent authorities in that regard; (3) assisting Member States and Union institutions, bodies, offices and agencies in developing and promoting cybersecurity policies related to sustaining the general availability or integrity of the public core of the open internet; (4) contributing to the work of the Cooperation Group pursuant to Article 11 of Directive (EU) 2016/1148, by providing its expertise and assistance; (5) supporting: (a) the development and implementation of Union policy in the field of electronic identity and trust services, in particular by providing advice and issuing technical guidelines, as well as by facilitating the exchange of best practices between competent authorities; (b) the promotion of an enhanced level of security of electronic communications, including by providing advice and expertise, as well as by facilitating the exchange of best practices between competent authorities; (c) Member States in the implementation of specific cybersecurity aspects of Union policy and law relating to data protection and privacy, including by providing advice to the European Data Protection Board upon request; (6) supporting the regular review of Union policy activities by preparing an annual report on the state of the implementation of the respective legal framework regarding: (a) information on Member States\u2019 incident notifications provided by the single points of contact to the Cooperation Group pursuant to Article 10(3) of Directive (EU) 2016/1148; (b) summaries of notifications of breach of security or loss of integrity received from trust service providers provided by the supervisory bodies to ENISA, pursuant to Article 19(3) of Regulation (EU) No 910/2014 of the European Parliament and of the Council (23); (c) notifications of security incidents transmitted by the providers of public electronic communications networks or of publicly available electronic communications services, provided by the competent authorities to ENISA, pursuant to Article 40 of Directive (EU) 2018/1972. Article 6 Capacity-building 1. ENISA shall assist: (a) Member States in their efforts to improve the prevention, detection and analysis of, and the capability to respond to cyber threats and incidents by providing them with knowledge and expertise; (b) Member States and Union institutions, bodies, offices and agencies in establishing and implementing vulnerability disclosure policies on a voluntary basis; (c) Union institutions, bodies, offices and agencies in their efforts to improve the prevention, detection and analysis of cyber threats and incidents and to improve their capabilities to respond to such cyber threats and incidents, in particular through appropriate support for the CERT-EU; (d) Member States in developing national CSIRTs, where requested pursuant to Article 9(5) of Directive (EU) 2016/1148; (e) Member States in developing national strategies on the security of network and information systems, where requested pursuant to Article 7(2) of Directive (EU) 2016/1148, and promote the dissemination of those strategies and note the progress in their implementation across the Union in order to promote best practices; (f) Union institutions in developing and reviewing Union strategies regarding cybersecurity, promoting their dissemination and tracking the progress in their implementation; (g) national and Union CSIRTs in raising the level of their capabilities, including by promoting dialogue and exchanges of information, with a view to ensuring that, with regard to the state of the art, each CSIRT possesses a common set of minimum capabilities and operates according to best practices; (h) Member States by regularly organising the cybersecurity exercises at Union level referred to in Article 7(5) on at least a biennial basis and by making policy recommendations based on the evaluation process of the exercises and lessons learned from them; (i) relevant public bodies by offering trainings regarding cybersecurity, where appropriate in cooperation with stakeholders; (j) the Cooperation Group, in the exchange of best practices, in particular with regard to the identification by Member States of operators of essential services, pursuant to point (l) of Article 11(3) of Directive (EU) 2016/1148, including in relation to cross-border dependencies, regarding risks and incidents. 2. ENISA shall support information sharing in and between sectors, in particular in the sectors listed in Annex II to Directive (EU) 2016/1148, by providing best practices and guidance on available tools, procedures, as well as on how to address regulatory issues related to information-sharing. Article 7 Operational cooperation at Union level 1. ENISA shall support operational cooperation among Member States, Union institutions, bodies, offices and agencies, and between stakeholders. 2. ENISA shall cooperate at the operational level and establish synergies with Union institutions, bodies, offices and agencies, including the CERT-EU, with the services dealing with cybercrime and with supervisory authorities dealing with the protection of privacy and personal data, with a view to addressing issues of common concern, including by means of: (a) the exchange of know-how and best practices; (b) the provision of advice and issuing of guidelines on relevant matters related to cybersecurity; (c) the establishment of practical arrangements for the execution of specific tasks, after consulting the Commission. 3. ENISA shall provide the secretariat of the CSIRTs network pursuant to Article 12(2) of Directive (EU) 2016/1148, and in that capacity shall actively support the information sharing and the cooperation among its members. 4. ENISA shall support Member States with respect to operational cooperation within the CSIRTs network by: (a) advising on how to improve their capabilities to prevent, detect and respond to incidents and, at the request of one or more Member States, providing advice in relation to a specific cyber threat; (b) assisting, at the request of one or more Member States, in the assessment of incidents having a significant or substantial impact through the provision of expertise and facilitating the technical handling of such incidents including in particular by supporting the voluntary sharing of relevant information and technical solutions between Member States; (c) analysing vulnerabilities and incidents on the basis of publicly available information or information provided voluntarily by Member States for that purpose; and (d) at the request of one or more Member States, providing support in relation to ex-post technical inquiries regarding incidents having a significant or substantial impact within the meaning of Directive (EU) 2016/1148. In performing those tasks, ENISA and CERT-EU shall engage in structured cooperation to benefit from synergies and to avoid the duplication of activities. 5. ENISA shall regularly organise cybersecurity exercises at Union level, and shall support Member States and Union institutions, bodies, offices and agencies in organising cybersecurity exercises following their requests. Such cybersecurity exercises at Union level may include technical, operational or strategic elements. On a biennial basis, ENISA shall organise a large-scale comprehensive exercise. Where appropriate, ENISA shall also contribute to and help organise sectoral cybersecurity exercises together with relevant organisations that also participate in cybersecurity exercises at Union level. 6. ENISA, in close cooperation with the Member States, shall prepare a regular in-depth EU Cybersecurity Technical Situation Report on incidents and cyber threats based on publicly available information, its own analysis, and reports shared by, among others, the Member States\u2019 CSIRTs or the single points of contact established by Directive (EU) 2016/1148, both on a voluntary basis, EC3 and CERT-EU. 7. ENISA shall contribute to developing a cooperative response at Union and Member States level to large-scale cross-border incidents or crises related to cybersecurity, mainly by: (a) aggregating and analysing reports from national sources that are in the public domain or shared on a voluntary basis with a view to contributing to the establishment of common situational awareness; (b) ensuring the efficient flow of information and the provision of escalation mechanisms between the CSIRTs network and the technical and political decision-makers at Union level; (c) upon request, facilitating the technical handling of such incidents or crises, including, in particular, by supporting the voluntary sharing of technical solutions between Member States; (d) supporting Union institutions, bodies, offices and agencies and, at their request, Member States, in the public communication relating to such incidents or crises; (e) testing the cooperation plans for responding to such incidents or crises at Union level and, at their request, supporting Member States in testing such plans at national level. Article 8 Market, cybersecurity certification, and standardisation 1. ENISA shall support and promote the development and implementation of Union policy on cybersecurity certification of ICT products, ICT services and ICT processes, as established in Title III of this Regulation, by: (a) monitoring developments, on an ongoing basis, in related areas of standardisation and recommending appropriate technical specifications for use in the development of European cybersecurity certification schemes pursuant to point (c) of Article 54(1) where standards are not available; (b) preparing candidate European cybersecurity certification schemes (\u2018candidate schemes\u2019) for ICT products, ICT services and ICT processes in accordance with Article 49; (c) evaluating adopted European cybersecurity certification schemes in accordance with Article 49(8); (d) participating in peer reviews pursuant to Article 59(4); (e) assisting the Commission in providing the secretariat of the ECCG pursuant to Article 62(5). 2. ENISA shall provide the secretariat of the Stakeholder Cybersecurity Certification Group pursuant to Article 22(4). 3. ENISA shall compile and publish guidelines and develop good practices, concerning the cybersecurity requirements for ICT products, ICT services and ICT processes, in cooperation with national cybersecurity certification authorities and industry in a formal, structured and transparent way. 4. ENISA shall contribute to capacity-building related to evaluation and certification processes by compiling and issuing guidelines as well as by providing support to Member States at their request. 5. ENISA shall facilitate the establishment and take-up of European and international standards for risk management and for the security of ICT products, ICT services and ICT processes. 6. ENISA shall draw up, in collaboration with Member States and industry, advice and guidelines regarding the technical areas related to the security requirements for operators of essential services and digital service providers, as well as regarding already existing standards, including Member States\u2019 national standards, pursuant to Article 19(2) of Directive (EU) 2016/1148. 7. ENISA shall perform and disseminate regular analyses of the main trends in the cybersecurity market on both the demand and supply sides, with a view to fostering the cybersecurity market in the Union. Article 9 Knowledge and information ENISA shall: (a) perform analyses of emerging technologies and provide topic-specific assessments on the expected societal, legal, economic and regulatory impact of technological innovations on cybersecurity; (b) perform long-term strategic analyses of cyber threats and incidents in order to identify emerging trends and help prevent incidents; (c) in cooperation with experts from Member States authorities and relevant stakeholders, provide advice, guidance and best practices for the security of network and information systems, in particular for the security of the infrastructures supporting the sectors listed in Annex II to Directive (EU) 2016/1148 and those used by the providers of the digital services listed in Annex III to that Directive; (d) through a dedicated portal, pool, organise and make available to the public information on cybersecurity provided by the Union institutions, bodies, offices and agencies and information on cybersecurity provided on a voluntary basis by Member States and private and public stakeholders; (e) collect and analyse publicly available information regarding significant incidents and compile reports with a view to providing guidance to citizens, organisations and businesses across the Union. Article 10 Awareness-raising and education ENISA shall: (a) raise public awareness of cybersecurity risks, and provide guidance on good practices for individual users aimed at citizens, organisations and businesses, including cyber-hygiene and cyber-literacy; (b) in cooperation with the Member States, Union institutions, bodies, offices and agencies and industry, organise regular outreach campaigns to increase cybersecurity and its visibility in the Union and encourage a broad public debate; (c) assist Member States in their efforts to raise cybersecurity awareness and promote cybersecurity education; (d) support closer coordination and exchange of best practices among Member States on cybersecurity awareness and education. Article 11 Research and innovation In relation to research and innovation, ENISA shall: (a) advise the Union institutions, bodies, offices and agencies and the Member States on research needs and priorities in the field of cybersecurity, with a view to enabling effective responses to current and emerging risks and cyber threats, including with respect to new and emerging information and communications technologies, and with a view to using risk-prevention technologies effectively; (b) where the Commission has conferred the relevant powers on it, participate in the implementation phase of research and innovation funding programmes or as a beneficiary; (c) contribute to the strategic research and innovation agenda at Union level in the field of cybersecurity. Article 12 International cooperation ENISA shall contribute to the Union\u2019s efforts to cooperate with third countries and international organisations as well as within relevant international cooperation frameworks to promote international cooperation on issues related to cybersecurity, by: (a) where appropriate, engaging as an observer in the organisation of international exercises, and analysing and reporting to the Management Board on the outcome of such exercises; (b) at the request of the Commission, facilitating the exchange of best practices; (c) at the request of the Commission, providing it with expertise; (d) providing advice and support to the Commission on matters concerning agreements for the mutual recognition of cybersecurity certificates with third countries, in collaboration with the ECCG established under Article 62. CHAPTER III Organisation of ENISA Article 13 Structure of ENISA The administrative and management structure of ENISA shall be composed of the following: (a) a Management Board; (b) an Executive Board; (c) an Executive Director; (d) an ENISA Advisory Group; (e) a National Liaison Officers Network. Section 1 Management Board Article 14 Composition of the Management Board 1. The Management Board shall be composed of one member appointed by each Member State, and two members appointed by the Commission. All members shall have the right to vote. 2. Each member of the Management Board shall have an alternate. That alternate shall represent the member in the member\u2019s absence. 3. Members of the Management Board and their alternates shall be appointed on the basis of their knowledge in the field of cybersecurity, taking into account their relevant managerial, administrative and budgetary skills. The Commission and the Member States shall make efforts to limit the turnover of their representatives on the Management Board, in order to ensure continuity of the Management Board\u2019s work. The Commission and the Member States shall aim to achieve gender balance on the Management Board. 4. The term of office of the members of the Management Board and their alternates shall be four years. That term shall be renewable. Article 15 Functions of the Management Board 1. The Management Board shall: (a) establish the general direction of the operation of ENISA and ensure that ENISA operates in accordance with the rules and principles laid down in this Regulation; it shall also ensure the consistency of ENISA\u2019s work with activities conducted by the Member States as well as at Union level; (b) adopt ENISA\u2019s draft single programming document referred to in Article 24, before its submission to the Commission for an opinion; (c) adopt ENISA\u2019s single programming document, taking into account the Commission opinion; (d) supervise the implementation of the multiannual and annual programming included in the single programming document; (e) adopt the annual budget of ENISA and exercise other functions in respect of ENISA\u2019s budget in accordance with Chapter IV; (f) assess and adopt the consolidated annual report on ENISA\u2019s activities, including the accounts and a description of how ENISA has met its performance indicators, submit both the annual report and the assessment thereof by 1 July of the following year, to the European Parliament, to the Council, to the Commission and to the Court of Auditors, and make the annual report public; (g) adopt the financial rules applicable to ENISA in accordance with Article 32; (h) adopt an anti-fraud strategy that is proportionate to the fraud risks, having regard to a cost-benefit analysis of the measures to be implemented; (i) adopt rules for the prevention and management of conflicts of interest in respect of its members; (j) ensure adequate follow-up to the findings and recommendations resulting from investigations of the European Anti-Fraud Office (OLAF) and the various internal or external audit reports and evaluations; (k) adopt its rules of procedure, including rules for provisional decisions on the delegation of specific tasks, pursuant to Article 19(7); (l) with respect to the staff of ENISA, exercise the powers conferred by the Staff Regulations of Officials (the \u2018Staff Regulations of Officials\u2019) and the Conditions of Employment of Other Servants of the European Union (the \u2018Conditions of Employment of Other Servants\u2019), laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (24) on the appointing authority and on the Authority Empowered to Conclude a Contract of Employment (\u2018appointing authority powers\u2019) in accordance with paragraph 2 of this Article; (m) adopt rules implementing the Staff Regulations of Officials and the Conditions of Employment of Other Servants in accordance with the procedure provided for in Article 110 of the Staff Regulations of Officials; (n) appoint the Executive Director and where relevant extend his or her term of office or remove him or her from office in accordance with Article 36; (o) appoint an accounting officer, who may be the Commission\u2019s accounting officer, who shall be wholly independent in the performance of his or her duties; (p) take all decisions concerning the establishment of ENISA\u2019s internal structures and, where necessary, the modification of those internal structures, taking into consideration ENISA\u2019s activity needs and having regard to sound budgetary management; (q) authorise the establishment of working arrangements with regard to Article 7; (r) authorise the establishment or conclusion of working arrangements in accordance with Article 42. 2. In accordance with Article 110 of the Staff Regulations of Officials, the Management Board shall adopt a decision based on Article 2(1) of the Staff Regulations of Officials and Article 6 of the Conditions of Employment of Other Servants, delegating the relevant appointing authority powers to the Executive Director and determining the conditions under which that delegation of powers can be suspended. The Executive Director may sub-delegate those powers. 3. Where exceptional circumstances so require, the Management Board may adopt a decision to temporarily suspend the delegation of appointing authority powers to the Executive Director and any appointing authority powers sub-delegated by the Executive Director and instead exercise them itself or delegate them to one of its members or to a staff member other than the Executive Director. Article 16 Chairperson of the Management Board The Management Board shall elect a Chairperson and a Deputy Chairperson from among its members, by a majority of two thirds of the members. Their terms of office shall be four years, which shall be renewable once. If, however, their membership of the Management Board ends at any time during their term of office, their term of office shall automatically expire on that date. The Deputy Chair shall replace the Chairperson ex officio if the Chairperson is unable to attend to his or her duties. Article 17 Meetings of the Management Board 1. Meetings of the Management Board shall be convened by its Chairperson. 2. The Management Board shall hold at least two ordinary meetings a year. It shall also hold extraordinary meetings at the request of its Chairperson, at the request of the Commission, or at the request of at least one third of its members. 3. The Executive Director shall take part in the meetings of the Management Board but shall not have the right to vote. 4. Members of the ENISA Advisory Group may take part in the meetings of the Management Board at the invitation of the Chairperson, but shall not have the right to vote. 5. The members of the Management Board and their alternates may be assisted at the meetings of the Management Board by advisers or experts, subject to the rules of procedure of the Management Board. 6. ENISA shall provide the secretariat of the Management Board. Article 18 Voting rules of the Management Board 1. The Management Board shall take its decisions by a majority of its members. 2. A majority of two-thirds of the members of the Management Board shall be required for the adoption of the single programming document and of the annual budget and for the appointment, extension of the term of office or removal of the Executive Director. 3. Each member shall have one vote. In the absence of a member, their alternate shall be entitled to exercise the member\u2019s right to vote. 4. The Chairperson of the Management Board shall take part in the voting. 5. The Executive Director shall not take part in the voting. 6. The Management Board\u2019s rules of procedure shall establish more detailed voting arrangements, in particular the circumstances in which a member may act on behalf of another member. Section 2 Executive Board Article 19 Executive Board 1. The Management Board shall be assisted by an Executive Board. 2. The Executive Board shall: (a) prepare decisions to be adopted by the Management Board; (b) together with the Management Board, ensure the adequate follow-up to the findings and recommendations stemming from investigations of OLAF and the various internal or external audit reports and evaluations; (c) without prejudice to the responsibilities of the Executive Director set out in Article 20, assist and advise the Executive Director in implementing the decisions of the Management Board on administrative and budgetary matters pursuant to Article 20. 3. The Executive Board shall be composed of five members. The members of the Executive Board shall be appointed from among the members of the Management Board. One of the members shall be the Chairperson of the Management Board, who may also chair the Executive Board, and another shall be one of the representatives of the Commission. The appointments of the members of the Executive Board shall aim to ensure gender balance on the Executive Board. The Executive Director shall take part in the meetings of the Executive Board but shall not have the right to vote. 4. The term of office of the members of the Executive Board shall be four years. That term shall be renewable. 5. The Executive Board shall meet at least once every three months. The Chairperson of the Executive Board shall convene additional meetings at the request of its members. 6. The Management Board shall lay down the rules of procedure of the Executive Board. 7. When necessary because of urgency, the Executive Board may take certain provisional decisions on behalf of the Management Board, in particular on administrative management matters, including the suspension of the delegation of the appointing authority powers and budgetary matters. Any such provisional decisions shall be notified to the Management Board without undue delay. The Management Board shall then decide whether to approve or reject the provisional decision no later than three months after the decision was taken. The Executive Board shall not take decisions on behalf of the Management Board that require the approval of a majority of two-thirds of the members of the Management Board. Section 3 Executive Director Article 20 Duties of the Executive Director 1. ENISA shall be managed by its Executive Director, who shall be independent in the performance of his or her duties. The Executive Director shall be accountable to the Management Board. 2. The Executive Director shall report to the European Parliament on the performance of his or her duties when invited to do so. The Council may invite the Executive Director to report on the performance of his or her duties. 3. The Executive Director shall be responsible for: (a) the day-to-day administration of ENISA; (b) implementing the decisions adopted by the Management Board; (c) preparing the draft single programming document and submitting it to the Management Board for approval before its submission to the Commission; (d) implementing the single programming document and reporting to the Management Board thereon; (e) preparing the consolidated annual report on ENISA\u2019s activities, including the implementation of ENISA\u2019s annual work programme, and presenting it to the Management Board for assessment and adoption; (f) preparing an action plan that follows up on the conclusions of the retrospective evaluations, and reporting on progress every two years to the Commission; (g) preparing an action plan that follows up on the conclusions of internal or external audit reports, as well as on investigations by OLAF and reporting on progress biannually to the Commission and regularly to the Management Board; (h) preparing the draft financial rules applicable to ENISA as referred to in Article 32; (i) preparing ENISA\u2019s draft statement of estimates of revenue and expenditure and implementing its budget; (j) protecting the financial interests of the Union by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties; (k) preparing an anti-fraud strategy for ENISA and presenting it to the Management Board for approval; (l) developing and maintaining contact with the business community and consumers\u2019 organisations to ensure regular dialogue with relevant stakeholders; (m) exchanging views and information regularly with Union institutions, bodies, offices and agencies regarding their activities relating to cybersecurity to ensure coherence in the development and the implementation of Union policy; (n) carrying out other tasks assigned to the Executive Director by this Regulation. 4. Where necessary and within ENISA\u2019s objectives and tasks, the Executive Director may set up ad hoc working groups composed of experts, including experts from the Member States\u2019 competent authorities. The Executive Director shall inform the Management Board in advance thereof. The procedures regarding in particular the composition of the working groups, the appointment of the experts of the working groups by the Executive Director and the operation of the working groups shall be specified in ENISA\u2019s internal rules of operation. 5. Where necessary, for the purpose of carrying out ENISA\u2019s tasks in an efficient and effective manner and based on an appropriate cost-benefit analysis, the Executive Director may decide to establish one or more local offices in one or more Member States. Before deciding to establish a local office, the Executive Director shall seek the opinion of the Member States concerned, including the Member State in which the seat of ENISA is located, and shall obtain the prior consent of the Commission and the Management Board. In cases of disagreement during the consultation process between the Executive Director and the Member States concerned, the issue shall be brought to the Council for discussion. The aggregate number of staff in all local offices shall be kept to a minimum and shall not exceed 40 % of the total number of ENISA\u2019s staff located in the Member State in which the seat of ENISA is located. The number of the staff in each local office shall not exceed 10 % of the total number of ENISA\u2019s staff located in the Member State in which the seat of ENISA is located. The decision establishing a local office shall specify the scope of the activities to be carried out at the local office in a manner that avoids unnecessary costs and duplication of administrative functions of ENISA. Section 4 ENISA Advisory Group, Stakeholder Cybersecurity Certification Group and National Liaison Officers Network Article 21 ENISA Advisory Group 1. The Management Board, acting on a proposal from the Executive Director, shall establish in a transparent manner the ENISA Advisory Group composed of recognised experts representing the relevant stakeholders, such as the ICT industry, providers of electronic communications networks or services available to the public, SMEs, operators of essential services, consumer groups, academic experts in the field of cybersecurity, and representatives of competent authorities notified in accordance with Directive (EU) 2018/1972, of European standardisation organisations, as well as of law enforcement and data protection supervisory authorities. The Management Board shall aim to ensure an appropriate gender and geographical balance as well as a balance between the different stakeholder groups. 2. Procedures for the ENISA Advisory Group, in particular regarding its composition, the proposal by the Executive Director referred to in paragraph 1, the number and appointment of its members and the operation of the ENISA Advisory Group, shall be specified in ENISA\u2019s internal rules of operation and shall be made public. 3. The ENISA Advisory Group shall be chaired by the Executive Director or by any person whom the Executive Director appoints on a case-by-case basis. 4. The term of office of the members of the ENISA Advisory Group shall be two-and-a-half years. Members of the Management Board shall not be members of the ENISA Advisory Group. Experts from the Commission and the Member States shall be entitled to be present at the meetings of the ENISA Advisory Group and to participate in its work. Representatives of other bodies deemed to be relevant by the Executive Director, who are not members of the ENISA Advisory Group, may be invited to attend the meetings of the ENISA Advisory Group and to participate in its work. 5. The ENISA Advisory Group shall advise ENISA in respect of the performance of ENISA\u2019s tasks, except of the application of the provisions of Title III of this Regulation. It shall in particular advise the Executive Director on the drawing up of a proposal for ENISA\u2019s annual work programme, and on ensuring communication with the relevant stakeholders on issues related to the annual work programme. 6. The ENISA Advisory Group shall inform the Management Board of its activities on a regular basis. Article 22 Stakeholder Cybersecurity Certification Group 1. The Stakeholder Cybersecurity Certification Group shall be established. 2. The Stakeholder Cybersecurity Certification Group shall be composed of members selected from among recognised experts representing the relevant stakeholders. The Commission, following a transparent and open call, shall select, on the basis of a proposal from ENISA, members of the Stakeholder Cybersecurity Certification Group ensuring a balance between the different stakeholder groups as well as an appropriate gender and geographical balance. 3. The Stakeholder Cybersecurity Certification Group shall: (a) advise the Commission on strategic issues regarding the European cybersecurity certification framework; (b) upon request, advise ENISA on general and strategic matters concerning ENISA\u2019s tasks relating to market, cybersecurity certification, and standardisation; (c) assist the Commission in the preparation of the Union rolling work programme referred to in Article 47; (d) issue an opinion on the Union rolling work programme pursuant to Article 47(4); and (e) in urgent cases, provide advice to the Commission and the ECCG on the need for additional certification schemes not included in the Union rolling work programme, as outlined in Articles 47 and 48. 4. The Stakeholder Certification Group shall be co-chaired by the representatives of the Commission and of ENISA, and its secretariat shall be provided by ENISA. Article 23 National Liaison Officers Network 1. The Management Board, acting on a proposal from the Executive Director, shall set up a National Liaison Officers Network composed of representatives of all Member States (National Liaison Officers). Each Member State shall appoint one representative to the National Liaison Officers Network. The meetings of the National Liaison Officers Network may be held in different expert formations. 2. The National Liaison Officers Network shall in particular facilitate the exchange of information between ENISA and the Member States, and shall support ENISA in disseminating its activities, findings and recommendations to the relevant stakeholders across the Union. 3. National Liaison Officers shall act as a point of contact at national level to facilitate cooperation between ENISA and national experts in the context of the implementation of ENISA\u2019s annual work programme. 4. While National Liaison Officers shall cooperate closely with the Management Board representatives of their respective Member States, the National Liaisons Officers Network itself shall not duplicate the work of the Management Board or of other Union forums. 5. The functions and procedures of the National Liaisons Officers Network shall be specified in ENISA\u2019s internal rules of operation and shall be made public. Section 5 Operation Article 24 Single programming document 1. ENISA shall operate in accordance with a single programming document containing its annual and multiannual programming, which shall include all of its planned activities. 2. Each year, the Executive Director shall draw up a draft single programming document containing its annual and multiannual programming with the corresponding financial and human resources planning in accordance with Article 32 of Commission Delegated Regulation (EU) No 1271/2013 (25) and taking into account the guidelines set by the Commission. 3. By 30 November each year, the Management Board shall adopt the single programming document referred to in paragraph 1 and shall transmit it to the European Parliament, to the Council and to the Commission by 31 January of the following year, as well as any subsequently updated versions of that document. 4. The single programming document shall become final after the definitive adoption of the general budget of the Union and shall be adjusted as necessary. 5. The annual work programme shall comprise detailed objectives and expected results including performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual work programme shall be coherent with the multiannual work programme referred to in paragraph 7. It shall clearly indicate tasks that have been added, changed or deleted in comparison with the previous financial year. 6. The Management Board shall amend the adopted annual work programme when a new task is assigned to ENISA. Any substantial amendments to the annual work programme shall be adopted by the same procedure as for the initial annual work programme. The Management Board may delegate the power to make non-substantial amendments to the annual work programme to the Executive Director. 7. The multiannual work programme shall set out the overall strategic programming including objectives, expected results and performance indicators. It shall also set out the resource programming including multi-annual budget and staff. 8. The resource programming shall be updated annually. The strategic programming shall be updated where appropriate and in particular where necessary to address the outcome of the evaluation referred to in Article 67. Article 25 Declaration of interests 1. Members of the Management Board, the Executive Director, and officials seconded by Member States on a temporary basis, shall each make a declaration of commitments and a declaration indicating the absence or presence of any direct or indirect interest which might be considered to be prejudicial to their independence. The declarations shall be accurate and complete, shall be made annually in writing, and shall be updated whenever necessary. 2. Members of the Management Board, the Executive Director, and external experts participating in ad hoc working groups, shall each accurately and completely declare, at the latest at the start of each meeting, any interest which might be considered to be prejudicial to their independence in relation to the items on the agenda, and shall abstain from participating in the discussion of and voting on such items. 3. ENISA shall lay down, in its internal rules of operation, the practical arrangements for the rules on declarations of interest referred to in paragraphs 1 and 2. Article 26 Transparency 1. ENISA shall carry out its activities with a high level of transparency and in accordance with Article 28. 2. ENISA shall ensure that the public and any interested parties are provided with appropriate, objective, reliable and easily accessible information, in particular with regard to the results of its work. It shall also make public the declarations of interest made in accordance with Article 25. 3. The Management Board, acting on a proposal from the Executive Director, may authorise interested parties to observe the proceedings of some of ENISA\u2019s activities. 4. ENISA shall lay down, in its internal rules of operation, the practical arrangements for implementing the transparency rules referred to in paragraphs 1 and 2. Article 27 Confidentiality 1. Without prejudice to Article 28, ENISA shall not divulge to third parties information that it processes or receives in relation to which a reasoned request for confidential treatment has been made. 2. Members of the Management Board, the Executive Director, the members of the ENISA Advisory Group, external experts participating in ad hoc working groups, and members of the staff of ENISA, including officials seconded by Member States on a temporary basis, shall comply with the confidentiality requirements of Article 339 TFEU, even after their duties have ceased. 3. ENISA shall lay down, in its internal rules of operation, the practical arrangements for implementing the confidentiality rules referred to in paragraphs 1 and 2. 4. If required for the performance of ENISA\u2019s tasks, the Management Board shall decide to allow ENISA to handle classified information. In that case ENISA, in agreement with the Commission services, shall adopt security rules applying the security principles set out in Commission Decisions (EU, Euratom) 2015/443 (26) and 2015/444 (27). Those security rules shall include provisions for the exchange, processing and storage of classified information. Article 28 Access to documents 1. Regulation (EC) No 1049/2001 shall apply to documents held by ENISA. 2. The Management Board shall adopt arrangements for implementing Regulation (EC) No 1049/2001 by 28 December 2019. 3. Decisions taken by ENISA pursuant to Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the European Ombudsman under Article 228 TFEU or of an action before the Court of Justice of the European Union under Article 263 TFEU. CHAPTER IV Establishment and structure of ENISA\u2019s budget Article 29 Establishment of ENISA\u2019s budget 1. Each year, the Executive Director shall draw up a draft statement of estimates of ENISA\u2019s revenue and expenditure for the following financial year, and shall transmit it to the Management Board, together with a draft establishment plan. Revenue and expenditure shall be in balance. 2. Each year the Management Board, on the basis of the draft statement of estimates, shall produce a statement of estimates of ENISA\u2019s revenue and expenditure for the following financial year. 3. The Management Board, by 31 January each year, shall send the statement of estimates, which shall be part of the draft single programming document, to the Commission and the third countries with which the Union has concluded agreements as referred to in Article 42(2). 4. On the basis of the statement of estimates, the Commission shall enter in the draft general budget of the Union the estimates it deems to be necessary for the establishment plan and the amount of the contribution to be charged to the general budget of the Union, which it shall submit to the European Parliament and to the Council in accordance with Article 314 TFEU. 5. The European Parliament and the Council shall authorise the appropriations for the contribution from the Union to ENISA. 6. The European Parliament and the Council shall adopt ENISA\u2019s establishment plan. 7. The Management Board shall adopt ENISA\u2019s budget together with the single programming document. ENISA\u2019s budget shall become final following the definitive adoption of the general budget of the Union. Where necessary, the Management Board shall adjust ENISA\u2019s budget and single programming document in accordance with the general budget of the Union. Article 30 Structure of ENISA\u2019s budget 1. Without prejudice to other resources, ENISA\u2019s revenue shall be composed of: (a) a contribution from the general budget of the Union; (b) revenue assigned to specific items of expenditure in accordance with its financial rules referred to in Article 32; (c) Union funding in the form of delegation agreements or ad hoc grants in accordance with its financial rules referred to in Article 32 and with the provisions of the relevant instruments supporting the policies of the Union; (d) contributions from third countries participating in the work of ENISA as referred to in Article 42; (e) any voluntary contributions from Member States in money or in kind. Member States that provide voluntary contributions under point (e) of the first subparagraph shall not claim any specific right or service as a result thereof. 2. The expenditure of ENISA shall include staff, administrative and technical support, infrastructure and operational expenses, and expenses resulting from contracts with third parties. Article 31 Implementation of ENISA\u2019s budget 1. The Executive Director shall be responsible for the implementation of ENISA\u2019s budget. 2. The Commission\u2019s internal auditor shall exercise the same powers over ENISA as over Commission departments. 3. ENISA\u2019s accounting officer shall send the provisional accounts for the financial year (year N) to the Commission\u2019s accounting officer and to the Court of Auditors by 1 March of the following financial year (year N + 1). 4. Upon the receipt of the Court of Auditors\u2019 observations on ENISA\u2019s provisional accounts pursuant to Article 246 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (28), ENISA\u2019s accounting officer shall draw up ENISA\u2019s final accounts under his or her responsibility and shall submit them to the Management Board for an opinion. 5. The Management Board shall deliver an opinion on ENISA\u2019s final accounts. 6. By 31 March of year N + 1, the Executive Director shall transmit the report on the budgetary and financial management to the European Parliament, to the Council, to the Commission and to the Court of Auditors. 7. By 1 July of year N + 1, ENISA\u2019s accounting officer shall transmit ENISA\u2019s final accounts to the European Parliament, to the Council, to the Commission\u2019s accounting officer and to the Court of Auditors, together with the Management Board\u2019s opinion. 8. At the same date as the transmission of ENISA\u2019s final accounts, ENISA\u2019s accounting officer shall also send to the Court of Auditors a representation letter covering those final accounts, with a copy to the Commission\u2019s accounting officer. 9. By 15 November of year N + 1, the Executive Director shall publish ENISA\u2019s final accounts in the Official Journal of the European Union. 10. By 30 September of year N + 1, the Executive Director shall send the Court of Auditors a reply to its observations and shall also send a copy of that reply to the Management Board and to the Commission. 11. The Executive Director shall submit to the European Parliament, at the latter\u2019s request, any information required for the smooth application of the discharge procedure for the financial year concerned in accordance with Article 261(3) of Regulation (EU, Euratom) 2018/1046. 12. On a recommendation from the Council, the European Parliament shall, before 15 May of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for the year N. Article 32 Financial rules The financial rules applicable to ENISA shall be adopted by the Management Board after consulting the Commission. They shall not depart from Delegated Regulation (EU) No 1271/2013 unless such a departure is specifically required for the operation of ENISA and the Commission has given its prior consent. Article 33 Combating fraud 1. In order to facilitate the combating of fraud, corruption and other unlawful activities under Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (29), ENISA shall by 28 December 2019, accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (30). ENISA shall adopt appropriate provisions applicable to all employees of ENISA, using the template set out in the Annex to that Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds from ENISA. 3. OLAF may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96 (31), with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant or a contract funded by ENISA. 4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries or international organisations, contracts, grant agreements and grant decisions of ENISA shall contain provisions expressly empowering the Court of Auditors and OLAF to conduct such audits and investigations, according to their respective competences. CHAPTER V Staff Article 34 General provisions The Staff Regulations of Officials and the Conditions of Employment of Other Servants, as well as the rules adopted by agreement between the Union institutions for giving effect to the Staff Regulations of Officials and the Conditions of Employment of Other Servants shall apply to the staff of ENISA. Article 35 Privileges and immunity Protocol No 7 on the privileges and immunities of the European Union, annexed to the TEU and to the TFEU, shall apply to ENISA and its staff. Article 36 Executive Director 1. The Executive Director shall be engaged as a temporary agent of ENISA under point (a) of Article 2 of the Conditions of Employment of Other Servants. 2. The Executive Director shall be appointed by the Management Board from a list of candidates proposed by the Commission, following an open and transparent selection procedure. 3. For the purpose of concluding the employment contract with the Executive Director, ENISA shall be represented by the Chairperson of the Management Board. 4. Before appointment, the candidate selected by the Management Board shall be invited to make a statement before the relevant committee of the European Parliament and to answer Members\u2019 questions. 5. The term of office of the Executive Director shall be five years. By the end of that period, the Commission shall carry out an assessment of the performance of the Executive Director and ENISA\u2019s future tasks and challenges. 6. The Management Board shall reach decisions on appointment, extension of the term of office or removal from office of the Executive Director in accordance with Article 18(2). 7. The Management Board, acting on a proposal from the Commission which takes into account the assessment referred to in paragraph 5, may extend the term of office of the Executive Director once by five years. 8. The Management Board shall inform the European Parliament about its intention to extend the Executive Director\u2019s term of office. Within three months before any such extension, the Executive Director, if invited, shall make a statement before the relevant committee of the European Parliament and answer Members\u2019 questions. 9. An Executive Director whose term of office has been extended shall not participate in another selection procedure for the same post. 10. The Executive Director may be removed from office only by decision of the Management Board acting on a proposal from the Commission. Article 37 Seconded national experts and other staff 1. ENISA may make use of seconded national experts or other staff not employed by ENISA. The Staff Regulations of Officials and the Conditions of Employment of Other Servants shall not apply to such staff. 2. The Management Board shall adopt a decision laying down rules on the secondment of national experts to ENISA. CHAPTER VI General provisions concerning ENISA Article 38 Legal status of ENISA 1. ENISA shall be a body of the Union and shall have legal personality. 2. In each Member State ENISA shall enjoy the most extensive legal capacity accorded to legal persons under national law. It may, in particular, acquire or dispose of movable and immovable property and be a party to legal proceedings. 3. ENISA shall be represented by the Executive Director. Article 39 Liability of ENISA 1. The contractual liability of ENISA shall be governed by the law applicable to the contract in question. 2. The Court of Justice of the European Union shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by ENISA. 3. In the case of non-contractual liability, ENISA shall make good any damage caused by it or its staff in the performance of their duties, in accordance with the general principles common to the laws of the Member States. 4. The Court of Justice of the European Union shall have jurisdiction in any dispute over compensation for damage as referred to in paragraph 3. 5. The personal liability of ENISA\u2019s staff towards ENISA shall be governed by the relevant conditions applying to ENISA\u2019s staff. Article 40 Language arrangements 1. Council Regulation No 1 (32) shall apply to ENISA. The Member States and the other bodies appointed by the Member States may address ENISA and receive a reply in the official language of the institutions of the Union that they choose. 2. The translation services required for the functioning of ENISA shall be provided by the Translation Centre for the Bodies of the European Union. Article 41 Protection of personal data 1. The processing of personal data by ENISA shall be subject to Regulation (EU) 2018/1725. 2. The Management Board shall adopt implementing rules as referred to in Article 45(3) of Regulation (EU) 2018/1725. The Management Board may adopt additional measures necessary for the application of Regulation (EU) 2018/1725 by ENISA. Article 42 Cooperation with third countries and international organisations 1. To the extent necessary in order to achieve the objectives set out in this Regulation, ENISA may cooperate with the competent authorities of third countries or with international organisations or both. To that end, ENISA may establish working arrangements with the authorities of third countries and international organisations, subject to the prior approval of the Commission. Those working arrangements shall not create legal obligations incumbent on the Union and its Member States. 2. ENISA shall be open to the participation of third countries that have concluded agreements with the Union to that effect. Under the relevant provisions of such agreements, working arrangements shall be established specifying in particular the nature, extent and manner in which those third countries are to participate in ENISA\u2019s work, and shall include provisions relating to participation in the initiatives undertaken by ENISA, to financial contributions and to staff. As regards staff matters, those working arrangements shall comply with the Staff Regulations of Officials and Conditions of Employment of Other Servants in any event. 3. The Management Board shall adopt a strategy for relations with third countries and international organisations concerning matters for which ENISA is competent. The Commission shall ensure that ENISA operates within its mandate and the existing institutional framework by concluding appropriate working arrangements with the Executive Director. Article 43 Security rules on the protection of sensitive non-classified information and classified information After consulting the Commission, ENISA shall adopt security rules applying the security principles contained in the Commission\u2019s security rules for protecting sensitive non-classified information and EUCI, as set out in Decisions (EU, Euratom) 2015/443 and 2015/444. ENISA\u2019s security rules shall include provisions for the exchange, processing and storage of such information. Article 44 Headquarters Agreement and operating conditions 1. The necessary arrangements concerning the accommodation to be provided for ENISA in the host Member State and the facilities to be made available by that Member State together with the specific rules applicable in the host Member State to the Executive Director, members of the Management Board, ENISA\u2019s staff and members of their families shall be laid down in a headquarters agreement between ENISA and the host Member State, concluded after obtaining the approval of the Management Board. 2. ENISA\u2019s host Member State shall provide the best possible conditions for ensuring the proper functioning of ENISA, taking into account the accessibility of the location, the existence of adequate education facilities for the children of staff members, appropriate access to the labour market, social security and medical care for both children and spouses of staff members. Article 45 Administrative control The operations of ENISA shall be supervised by the European Ombudsman in accordance with Article 228 TFEU. TITLE III CYBERSECURITY CERTIFICATION FRAMEWORK Article 46 European cybersecurity certification framework 1. The European cybersecurity certification framework shall be established in order to improve the conditions for the functioning of the internal market by increasing the level of cybersecurity within the Union and enabling a harmonised approach at Union level to European cybersecurity certification schemes, with a view to creating a digital single market for ICT products, ICT services and ICT processes. 2. The European cybersecurity certification framework shall provide for a mechanism to establish European cybersecurity certification schemes and to attest that the ICT products, ICT services and ICT processes that have been evaluated in accordance with such schemes comply with specified security requirements for the purpose of protecting the availability, authenticity, integrity or confidentiality of stored or transmitted or processed data or the functions or services offered by, or accessible via, those products, services and processes throughout their life cycle. Article 47 The Union rolling work programme for European cybersecurity certification 1. The Commission shall publish a Union rolling work programme for European cybersecurity certification (the \u2018Union rolling work programme\u2019) that shall identify strategic priorities for future European cybersecurity certification schemes. 2. The Union rolling work programme shall in particular include a list of ICT products, ICT services and ICT processes or categories thereof that are capable of benefiting from being included in the scope of a European cybersecurity certification scheme. 3. Inclusion of specific ICT products, ICT services and ICT processes or categories thereof in the Union rolling work programme shall be justified on the basis of one or more of the following grounds: (a) the availability and the development of national cybersecurity certification schemes covering a specific category of ICT products, ICT services or ICT processes and, in particular, as regards the risk of fragmentation; (b) relevant Union or Member State law or policy; (c) market demand; (d) developments in the cyber threat landscape; (e) request for the preparation of a specific candidate scheme by the ECCG. 4. The Commission shall take due account of the opinions issued by the ECCG and the Stakeholder Certification Group on the draft Union rolling work programme. 5. The first Union rolling work programme shall be published by 28 June 2020. The Union rolling work programme shall be updated at least once every three years and more often if necessary. Article 48 Request for a European cybersecurity certification scheme 1. The Commission may request ENISA to prepare a candidate scheme or to review an existing European cybersecurity certification scheme on the basis of the Union rolling work programme. 2. In duly justified cases, the Commission or the ECCG may request ENISA to prepare a candidate scheme or to review an existing European cybersecurity certification scheme which is not included in the Union rolling work programme. The Union rolling work programme shall be updated accordingly. Article 49 Preparation, adoption and review of a European cybersecurity certification scheme 1. Following a request from the Commission pursuant to Article 48, ENISA shall prepare a candidate scheme which meets the requirements set out in Articles 51, 52 and 54. 2. Following a request from the ECCG pursuant to Article 48(2), ENISA may prepare a candidate scheme which meets the requirements set out in Articles 51, 52 and 54. If ENISA refuses such a request, it shall give reasons for its refusal. Any decision to refuse such a request shall be taken by the Management Board. 3. When preparing a candidate scheme, ENISA shall consult all relevant stakeholders by means of a formal, open, transparent and inclusive consultation process. 4. For each candidate scheme, ENISA shall establish an ad hoc working group in accordance with Article 20(4) for the purpose of providing ENISA with specific advice and expertise. 5. ENISA shall closely cooperate with the ECCG. The ECCG shall provide ENISA with assistance and expert advice in relation to the preparation of the candidate scheme and shall adopt an opinion on the candidate scheme. 6. ENISA shall take utmost account of the opinion of the ECCG before transmitting the candidate scheme prepared in accordance with paragraphs 3, 4 and 5 to the Commission. The opinion of the ECCG shall not bind ENISA, nor shall the absence of such an opinion prevent ENISA from transmitting the candidate scheme to the Commission. 7. The Commission, based on the candidate scheme prepared by ENISA, may adopt implementing acts providing for a European cybersecurity certification scheme for ICT products, ICT services and ICT processes which meets the requirements set out in Articles 51, 52 and 54. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 66(2). 8. At least every five years, ENISA shall evaluate each adopted European cybersecurity certification scheme, taking into account the feedback received from interested parties. If necessary, the Commission or the ECCG may request ENISA to start the process of developing a revised candidate scheme in accordance with Article 48 and this Article. Article 50 Website on European cybersecurity certification schemes 1. ENISA shall maintain a dedicated website providing information on, and publicising, European cybersecurity certification schemes, European cybersecurity certificates and EU statements of conformity, including information with regard to European cybersecurity certification schemes which are no longer valid, to withdrawn and expired European cybersecurity certificates and EU statements of conformity, and to the repository of links to cybersecurity information provided in accordance with Article 55. 2. Where applicable, the website referred to in paragraph 1 shall also indicate the national cybersecurity certification schemes that have been replaced by a European cybersecurity certification scheme. Article 51 Security objectives of European cybersecurity certification schemes A European cybersecurity certification scheme shall be designed to achieve, as applicable, at least the following security objectives: (a) to protect stored, transmitted or otherwise processed data against accidental or unauthorised storage, processing, access or disclosure during the entire life cycle of the ICT product, ICT service or ICT process; (b) to protect stored, transmitted or otherwise processed data against accidental or unauthorised destruction, loss or alteration or lack of availability during the entire life cycle of the ICT product, ICT service or ICT process; (c) that authorised persons, programs or machines are able only to access the data, services or functions to which their access rights refer; (d) to identify and document known dependencies and vulnerabilities; (e) to record which data, services or functions have been accessed, used or otherwise processed, at what times and by whom; (f) to make it possible to check which data, services or functions have been accessed, used or otherwise processed, at what times and by whom; (g) to verify that ICT products, ICT services and ICT processes do not contain known vulnerabilities; (h) to restore the availability and access to data, services and functions in a timely manner in the event of a physical or technical incident; (i) that ICT products, ICT services and ICT processes are secure by default and by design; (j) that ICT products, ICT services and ICT processes are provided with up-to-date software and hardware that do not contain publicly known vulnerabilities, and are provided with mechanisms for secure updates. Article 52 Assurance levels of European cybersecurity certification schemes 1. A European cybersecurity certification scheme may specify one or more of the following assurance levels for ICT products, ICT services and ICT processes: \u2018basic\u2019, \u2018substantial\u2019 or \u2018high\u2019. The assurance level shall be commensurate with the level of the risk associated with the intended use of the ICT product, ICT service or ICT process, in terms of the probability and impact of an incident. 2. European cybersecurity certificates and EU statements of conformity shall refer to any assurance level specified in the European cybersecurity certification scheme under which the European cybersecurity certificate or EU statement of conformity is issued. 3. The security requirements corresponding to each assurance level shall be provided in the relevant European cybersecurity certification scheme, including the corresponding security functionalities and the corresponding rigour and depth of the evaluation that the ICT product, ICT service or ICT process is to undergo. 4. The certificate or the EU statement of conformity shall refer to technical specifications, standards and procedures related thereto, including technical controls, the purpose of which is to decrease the risk of, or to prevent cybersecurity incidents. 5. A European cybersecurity certificate or EU statement of conformity that refers to assurance level \u2018basic\u2019 shall provide assurance that the ICT products, ICT services and ICT processes for which that certificate or that EU statement of conformity is issued meet the corresponding security requirements, including security functionalities, and that they have been evaluated at a level intended to minimise the known basic risks of incidents and cyberattacks. The evaluation activities to be undertaken shall include at least a review of technical documentation. Where such a review is not appropriate, substitute evaluation activities with equivalent effect shall be undertaken. 6. A European cybersecurity certificate that refers to assurance level \u2018substantial\u2019 shall provide assurance that the ICT products, ICT services and ICT processes for which that certificate is issued meet the corresponding security requirements, including security functionalities, and that they have been evaluated at a level intended to minimise the known cybersecurity risks, and the risk of incidents and cyberattacks carried out by actors with limited skills and resources. The evaluation activities to be undertaken shall include at least the following: a review to demonstrate the absence of publicly known vulnerabilities and testing to demonstrate that the ICT products, ICT services or ICT processes correctly implement the necessary security functionalities. Where any such evaluation activities are not appropriate, substitute evaluation activities with equivalent effect shall be undertaken. 7. A European cybersecurity certificate that refers to assurance level \u2018high\u2019 shall provide assurance that the ICT products, ICT services and ICT processes for which that certificate is issued meet the corresponding security requirements, including security functionalities, and that they have been evaluated at a level intended to minimise the risk of state-of-the-art cyberattacks carried out by actors with significant skills and resources. The evaluation activities to be undertaken shall include at least the following: a review to demonstrate the absence of publicly known vulnerabilities; testing to demonstrate that the ICT products, ICT services or ICT processes correctly implement the necessary security functionalities at the state of the art; and an assessment of their resistance to skilled attackers, using penetration testing. Where any such evaluation activities are not appropriate, substitute activities with equivalent effect shall be undertaken. 8. A European cybersecurity certification scheme may specify several evaluation levels depending on the rigour and depth of the evaluation methodology used. Each of the evaluation levels shall correspond to one of the assurance levels and shall be defined by an appropriate combination of assurance components. Article 53 Conformity self-assessment 1. A European cybersecurity certification scheme may allow for the conformity self-assessment under the sole responsibility of the manufacturer or provider of ICT products, ICT services or ICT processes. Conformity self-assessment shall be permitted only in relation to ICT products, ICT services and ICT processes that present a low risk corresponding to assurance level \u2018basic\u2019. 2. The manufacturer or provider of ICT products, ICT services or ICT processes may issue an EU statement of conformity stating that the fulfilment of the requirements set out in the scheme has been demonstrated. By issuing such a statement, the manufacturer or provider of ICT products, ICT services or ICT processes shall assume responsibility for the compliance of the ICT product, ICT service or ICT process with the requirements set out in that scheme. 3. The manufacturer or provider of ICT products, ICT services or ICT processes shall make the EU statement of conformity, technical documentation, and all other relevant information relating to the conformity of the ICT products or ICT services with the scheme available to the national cybersecurity certification authority referred to in Article 58 for the period provided for in the corresponding European cybersecurity certification scheme. A copy of the EU statement of conformity shall be submitted to the national cybersecurity certification authority and to ENISA. 4. The issuing of an EU statement of conformity is voluntary, unless otherwise specified in Union law or Member State law. 5. EU statements of conformity shall be recognised in all Member States. Article 54 Elements of European cybersecurity certification schemes 1. A European cybersecurity certification scheme shall include at least the following elements: (a) the subject matter and scope of the certification scheme, including the type or categories of ICT products, ICT services and ICT processes covered; (b) a clear description of the purpose of the scheme and of how the selected standards, evaluation methods and assurance levels correspond to the needs of the intended users of the scheme; (c) references to the international, European or national standards applied in the evaluation or, where such standards are not available or appropriate, to technical specifications that meet the requirements set out in Annex II to Regulation (EU) No 1025/2012 or, if such specifications are not available, to technical specifications or other cybersecurity requirements defined in the European cybersecurity certification scheme; (d) where applicable, one or more assurance levels; (e) an indication of whether conformity self-assessment is permitted under the scheme; (f) where applicable, specific or additional requirements to which conformity assessment bodies are subject in order to guarantee their technical competence to evaluate the cybersecurity requirements; (g) the specific evaluation criteria and methods to be used, including types of evaluation, in order to demonstrate that the security objectives referred to in Article 51 are achieved; (h) where applicable, the information which is necessary for certification and which is to be supplied or otherwise be made available to the conformity assessment bodies by an applicant; (i) where the scheme provides for marks or labels, the conditions under which such marks or labels may be used; (j) rules for monitoring compliance of ICT products, ICT services and ICT processes with the requirements of the European cybersecurity certificates or the EU statements of conformity, including mechanisms to demonstrate continued compliance with the specified cybersecurity requirements; (k) where applicable, the conditions for issuing, maintaining, continuing and renewing the European cybersecurity certificates, as well as the conditions for extending or reducing the scope of certification; (l) rules concerning the consequences for ICT products, ICT services and ICT processes that have been certified or for which an EU statement of conformity has been issued, but which do not comply with the requirements of the scheme; (m) rules concerning how previously undetected cybersecurity vulnerabilities in ICT products, ICT services and ICT processes are to be reported and dealt with; (n) where applicable, rules concerning the retention of records by conformity assessment bodies; (o) the identification of national or international cybersecurity certification schemes covering the same type or categories of ICT products, ICT services and ICT processes, security requirements, evaluation criteria and methods, and assurance levels; (p) the content and the format of the European cybersecurity certificates and the EU statements of conformity to be issued; (q) the period of the availability of the EU statement of conformity, technical documentation, and all other relevant information to be made available by the manufacturer or provider of ICT products, ICT services or ICT processes; (r) maximum period of validity of European cybersecurity certificates issued under the scheme; (s) disclosure policy for European cybersecurity certificates issued, amended or withdrawn under the scheme; (t) conditions for the mutual recognition of certification schemes with third countries; (u) where applicable, rules concerning any peer assessment mechanism established by the scheme for the authorities or bodies issuing European cybersecurity certificates for assurance level \u2018high\u2019 pursuant to Article 56(6). Such mechanism shall be without prejudice to the peer review provided for in Article 59; (v) format and procedures to be followed by manufacturers or providers of ICT products, ICT services or ICT processes in supplying and updating the supplementary cybersecurity information in accordance with Article 55. 2. The specified requirements of the European cybersecurity certification scheme shall be consistent with any applicable legal requirements, in particular requirements emanating from harmonised Union law. 3. Where a specific Union legal act so provides, a certificate or an EU statement of conformity issued under a European cybersecurity certification scheme may be used to demonstrate the presumption of conformity with requirements of that legal act. 4. In the absence of harmonised Union law, Member State law may also provide that a European cybersecurity certification scheme may be used for establishing the presumption of conformity with legal requirements. Article 55 Supplementary cybersecurity information for certified ICT products, ICT services and ICT processes 1. The manufacturer or provider of certified ICT products, ICT services or ICT processes or of ICT products, ICT services and ICT processes for which an EU statement of conformity has been issued shall make publicly available the following supplementary cybersecurity information: (a) guidance and recommendations to assist end users with the secure configuration, installation, deployment, operation and maintenance of the ICT products or ICT services; (b) the period during which security support will be offered to end users, in particular as regards the availability of cybersecurity related updates; (c) contact information of the manufacturer or provider and accepted methods for receiving vulnerability information from end users and security researchers; (d) a reference to online repositories listing publicly disclosed vulnerabilities related to the ICT product, ICT service or ICT process and to any relevant cybersecurity advisories. 2. The information referred to in paragraph 1 shall be available in electronic form and shall remain available and be updated as necessary at least until the expiry of the corresponding European cybersecurity certificate or EU statement of conformity. Article 56 Cybersecurity certification 1. ICT products, ICT services and ICT processes that have been certified under a European cybersecurity certification scheme adopted pursuant to Article 49 shall be presumed to comply with the requirements of such scheme. 2. The cybersecurity certification shall be voluntary, unless otherwise specified by Union law or Member State law. 3. The Commission shall regularly assess the efficiency and use of the adopted European cybersecurity certification schemes and whether a specific European cybersecurity certification scheme is to be made mandatory through relevant Union law to ensure an adequate level of cybersecurity of ICT products, ICT services and ICT processes in the Union and improve the functioning of the internal market. The first such assessment shall be carried out by 31 December 2023, and subsequent assessments shall be carried out at least every two years thereafter. Based on the outcome of those assessments, the Commission shall identify the ICT products, ICT services and ICT processes covered by an existing certification scheme which are to be covered by a mandatory certification scheme. As a priority, the Commission shall focus on the sectors listed in Annex II to Directive (EU) 2016/1148, which shall be assessed at the latest two years after the adoption of the first European cybersecurity certification scheme. When preparing the assessment the Commission shall: (a) take into account the impact of the measures on the manufacturers or providers of such ICT products, ICT services or ICT processes and on the users in terms of the cost of those measures and the societal or economic benefits stemming from the anticipated enhanced level of security for the targeted ICT products, ICT services or ICT processes; (b) take into account the existence and implementation of relevant Member State and third country law; (c) carry out an open, transparent and inclusive consultation process with all relevant stakeholders and Member States; (d) take into account any implementation deadlines, transitional measures and periods, in particular with regard to the possible impact of the measure on the manufacturers or providers of ICT products, ICT services or ICT processes, including SMEs; (e) propose the most speedy and efficient way in which the transition from a voluntary to mandatory certification schemes is to be implemented. 4. The conformity assessment bodies referred to in Article 60 shall issue European cybersecurity certificates pursuant to this Article referring to assurance level \u2018basic\u2019 or \u2018substantial\u2019 on the basis of criteria included in the European cybersecurity certification scheme adopted by the Commission pursuant to Article 49. 5. By way of derogation from paragraph 4, in duly justified cases a European cybersecurity certification scheme may provide that European cybersecurity certificates resulting from that scheme are to be issued only by a public body. Such body shall be one of the following: (a) a national cybersecurity certification authority as referred to in Article 58(1); or (b) a public body that is accredited as a conformity assessment body pursuant to Article 60(1). 6. Where a European cybersecurity certification scheme adopted pursuant to Article 49 requires an assurance level \u2018high\u2019, the European cybersecurity certificate under that scheme is to be issued only by a national cybersecurity certification authority or, in the following cases, by a conformity assessment body: (a) upon prior approval by the national cybersecurity certification authority for each individual European cybersecurity certificate issued by a conformity assessment body; or (b) on the basis of a general delegation of the task of issuing such European cybersecurity certificates to a conformity assessment body by the national cybersecurity certification authority. 7. The natural or legal person who submits ICT products, ICT services or ICT processes for certification shall make available to the national cybersecurity certification authority referred to in Article 58, where that authority is the body issuing the European cybersecurity certificate, or to the conformity assessment body referred to in Article 60 all information necessary to conduct the certification. 8. The holder of a European cybersecurity certificate shall inform the authority or body referred to in paragraph 7 of any subsequently detected vulnerabilities or irregularities concerning the security of the certified ICT product, ICT service or ICT process that may have an impact on its compliance with the requirements related to the certification. That authority or body shall forward that information without undue delay to the national cybersecurity certification authority concerned. 9. A European cybersecurity certificate shall be issued for the period provided for in the European cybersecurity certification scheme and may be renewed, provided that the relevant requirements continue to be met. 10. A European cybersecurity certificate issued pursuant to this Article shall be recognised in all Member States. Article 57 National cybersecurity certification schemes and certificates 1. Without prejudice to paragraph 3 of this Article, national cybersecurity certification schemes, and the related procedures for the ICT products, ICT services and ICT processes that are covered by a European cybersecurity certification scheme shall cease to produce effects from the date established in the implementing act adopted pursuant to Article 49(7). National cybersecurity certification schemes and the related procedures for the ICT products, ICT services and ICT processes that are not covered by a European cybersecurity certification scheme shall continue to exist. 2. Member States shall not introduce new national cybersecurity certification schemes for ICT products, ICT services and ICT processes already covered by a European cybersecurity certification scheme that is in force. 3. Existing certificates that were issued under national cybersecurity certification schemes and are covered by a European cybersecurity certification scheme shall remain valid until their expiry date. 4. With a view to avoiding the fragmentation of the internal market, Member States shall inform the Commission and the ECCG of any intention to draw up new national cybersecurity certification schemes. Article 58 National cybersecurity certification authorities 1. Each Member State shall designate one or more national cybersecurity certification authorities in its territory or, with the agreement of another Member State, shall designate one or more national cybersecurity certification authorities established in that other Member State to be responsible for the supervisory tasks in the designating Member State. 2. Each Member State shall inform the Commission of the identity of the designated national cybersecurity certification authorities. Where a Member State designates more than one authority, it shall also inform the Commission about the tasks assigned to each of those authorities. 3. Without prejudice to point (a) of Article 56(5) and Article 56(6), each national cybersecurity certification authority shall be independent of the entities it supervises in its organisation, funding decisions, legal structure and decision-making. 4. Member States shall ensure that the activities of the national cybersecurity certification authorities that relate to the issuance of European cybersecurity certificates referred to in point (a) of Article 56(5) and in Article 56(6) are strictly separated from their supervisory activities set out in this Article and that those activities are carried out independently from each other. 5. Member States shall ensure that national cybersecurity certification authorities have adequate resources to exercise their powers and to carry out their tasks in an effective and efficient manner. 6. For the effective implementation of this Regulation, it is appropriate that national cybersecurity certification authorities participate in the ECCG in an active, effective, efficient and secure manner. 7. National cybersecurity certification authorities shall: (a) supervise and enforce rules included in European cybersecurity certification schemes pursuant to point (j) of Article 54(1) for the monitoring of the compliance of ICT products, ICT services and ICT processes with the requirements of the European cybersecurity certificates that have been issued in their respective territories, in cooperation with other relevant market surveillance authorities; (b) monitor compliance with and enforce the obligations of the manufacturers or providers of ICT products, ICT services or ICT processes that are established in their respective territories and that carry out conformity self-assessment, and shall, in particular, monitor compliance with and enforce the obligations of such manufacturers or providers set out in Article 53(2) and (3) and in the corresponding European cybersecurity certification scheme; (c) without prejudice to Article 60(3), actively assist and support the national accreditation bodies in the monitoring and supervision of the activities of conformity assessment bodies, for the purposes of this Regulation; (d) monitor and supervise the activities of the public bodies referred to in Article 56(5); (e) where applicable, authorise conformity assessment bodies in accordance with Article 60(3) and restrict, suspend or withdraw existing authorisation where conformity assessment bodies infringe the requirements of this Regulation; (f) handle complaints by natural or legal persons in relation to European cybersecurity certificates issued by national cybersecurity certification authorities or to European cybersecurity certificates issued by conformity assessment bodies in accordance with Article 56(6) or in relation to EU statements of conformity issued under Article 53, and shall investigate the subject matter of such complaints to the extent appropriate, and shall inform the complainant of the progress and the outcome of the investigation within a reasonable period; (g) provide an annual summary report on the activities conducted under points (b), (c) and (d) of this paragraph or under paragraph 8 to ENISA and the ECCG; (h) cooperate with other national cybersecurity certification authorities or other public authorities, including by sharing information on the possible non-compliance of ICT products, ICT services and ICT processes with the requirements of this Regulation or with the requirements of specific European cybersecurity certification schemes; and (i) monitor relevant developments in the field of cybersecurity certification. 8. Each national cybersecurity certification authority shall have at least the following powers: (a) to request conformity assessment bodies, European cybersecurity certificates\u2019 holders and issuers of EU statements of conformity to provide any information it requires for the performance of its tasks; (b) to carry out investigations, in the form of audits, of conformity assessment bodies, European cybersecurity certificates\u2019 holders and issuers of EU statements of conformity, for the purpose of verifying their compliance with this Title; (c) to take appropriate measures, in accordance with national law, to ensure that conformity assessment bodies, European cybersecurity certificates\u2019 holders and issuers of EU statements of conformity comply with this Regulation or with a European cybersecurity certification scheme; (d) to obtain access to the premises of any conformity assessment bodies or holders of European cybersecurity certificates, for the purpose of carrying out investigations in accordance with Union or Member State procedural law; (e) to withdraw, in accordance with national law, European cybersecurity certificates issued by the national cybersecurity certification authorities or European cybersecurity certificates issued by conformity assessment bodies in accordance with Article 56(6), where such certificates do not comply with this Regulation or with a European cybersecurity certification scheme; (f) to impose penalties in accordance with national law, as provided for in Article 65, and to require the immediate cessation of infringements of the obligations set out in this Regulation. 9. National cybersecurity certification authorities shall cooperate with each other and with the Commission, in particular, by exchanging information, experience and good practices as regards cybersecurity certification and technical issues concerning the cybersecurity of ICT products, ICT services and ICT processes. Article 59 Peer review 1. With a view to achieving equivalent standards throughout the Union in respect of European cybersecurity certificates and EU statements of conformity, national cybersecurity certification authorities shall be subject to peer review. 2. Peer review shall be carried out on the basis of sound and transparent evaluation criteria and procedures, in particular concerning structural, human resource and process requirements, confidentiality and complaints. 3. Peer review shall assess: (a) where applicable, whether the activities of the national cybersecurity certification authorities that relate to the issuance of European cybersecurity certificates referred to in point (a) of Article 56(5) and in Article 56(6) are strictly separated from their supervisory activities set out in Article 58 and whether those activities are carried out independently from each other; (b) the procedures for supervising and enforcing the rules for monitoring the compliance of ICT products, ICT services and ICT processes with European cybersecurity certificates pursuant to point (a) of Article 58(7); (c) the procedures for monitoring and enforcing the obligations of manufacturers or providers of ICT products, ICT services or ICT processes pursuant to point (b) of Article 58(7); (d) the procedures for monitoring, authorising and supervising the activities of the conformity assessment bodies; (e) where applicable, whether the staff of authorities or bodies that issue certificates for assurance level \u2018high\u2019 pursuant to Article 56(6) have the appropriate expertise. 4. Peer review shall be carried out by at least two national cybersecurity certification authorities of other Member States and the Commission and shall be carried out at least once every five years. ENISA may participate in the peer review. 5. The Commission may adopt implementing acts establishing a plan for peer review which covers a period of at least five years, laying down the criteria concerning the composition of the peer review team, the methodology to be used in peer review, and the schedule, the frequency and other tasks related to it. In adopting those implementing acts, the Commission shall take due account of the views of the ECCG. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 66(2). 6. The outcomes of peer reviews shall be examined by the ECCG, which shall draw up summaries that may be made publicly available and which shall, where necessary, issue guidelines or recommendations on actions or measures to be taken by the entities concerned. Article 60 Conformity assessment bodies 1. The conformity assessment bodies shall be accredited by national accreditation bodies appointed pursuant to Regulation (EC) No 765/2008. Such accreditation shall be issued only where the conformity assessment body meets the requirements set out in the Annex to this Regulation. 2. Where a European cybersecurity certificate is issued by a national cybersecurity certification authority pursuant to point (a) of Article 56(5) and Article 56(6), the certification body of the national cybersecurity certification authority shall be accredited as a conformity assessment body pursuant to paragraph 1 of this Article. 3. Where European cybersecurity certification schemes set out specific or additional requirements pursuant to point (f) of Article 54(1), only conformity assessment bodies that meet those requirements shall be authorised by the national cybersecurity certification authority to carry out tasks under such schemes. 4. The accreditation referred to in paragraph 1 shall be issued to the conformity assessment bodies for a maximum of five years and may be renewed on the same conditions, provided that the conformity assessment body still meets the requirements set out in this Article. National accreditation bodies shall take all appropriate measures within a reasonable timeframe to restrict, suspend or revoke the accreditation of a conformity assessment body issued pursuant to paragraph 1 where the conditions for the accreditation have not been met or are no longer met, or where the conformity assessment body infringes this Regulation. Article 61 Notification 1. For each European cybersecurity certification scheme, the national cybersecurity certification authorities shall notify the Commission of the conformity assessment bodies that have been accredited and, where applicable, authorised pursuant to Article 60(3) to issue European cybersecurity certificates at specified assurance levels as referred to in Article 52. The national cybersecurity certification authorities shall notify the Commission of any subsequent changes thereto without undue delay. 2. One year after the entry into force of a European cybersecurity certification scheme, the Commission shall publish a list of the conformity assessment bodies notified under that scheme in the Official Journal of the European Union. 3. If the Commission receives a notification after the expiry of the period referred to in paragraph 2, it shall publish the amendments to the list of notified conformity assessment bodies in the Official Journal of the European Union within two months of the date of receipt of that notification. 4. A national cybersecurity certification authority may submit to the Commission a request to remove a conformity assessment body notified by that authority from the list referred to in paragraph 2. The Commission shall publish the corresponding amendments to that list in the Official Journal of the European Union within one month of the date of receipt of the national cybersecurity certification authority\u2019s request. 5. The Commission may adopt implementing acts to establish the circumstances, formats and procedures for notifications referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 66(2). Article 62 European Cybersecurity Certification Group 1. The European Cybersecurity Certification Group (the \u2018ECCG\u2019) shall be established. 2. The ECCG shall be composed of representatives of national cybersecurity certification authorities or representatives of other relevant national authorities. A member of the ECCG shall not represent more than two Member States. 3. Stakeholders and relevant third parties may be invited to attend meetings of the ECCG and to participate in its work. 4. The ECCG shall have the following tasks: (a) to advise and assist the Commission in its work to ensure the consistent implementation and application of this Title, in particular regarding the Union rolling work programme, cybersecurity certification policy issues, the coordination of policy approaches, and the preparation of European cybersecurity certification schemes; (b) to assist, advise and cooperate with ENISA in relation to the preparation of a candidate scheme pursuant to Article 49; (c) to adopt an opinion on candidate schemes prepared by ENISA pursuant to Article 49; (d) to request ENISA to prepare candidate schemes pursuant to Article 48(2); (e) to adopt opinions addressed to the Commission relating to the maintenance and review of existing European cybersecurity certifications schemes; (f) to examine relevant developments in the field of cybersecurity certification and to exchange information and good practices on cybersecurity certification schemes; (g) to facilitate the cooperation between national cybersecurity certification authorities under this Title through capacity-building and the exchange of information, in particular by establishing methods for the efficient exchange of information relating to issues concerning cybersecurity certification; (h) to support the implementation of peer assessment mechanisms in accordance with the rules established in a European cybersecurity certification scheme pursuant to point (u) of Article 54(1); (i) to facilitate the alignment of European cybersecurity certification schemes with internationally recognised standards, including by reviewing existing European cybersecurity certification schemes and, where appropriate, making recommendations to ENISA to engage with relevant international standardisation organisations to address insufficiencies or gaps in available internationally recognised standards. 5. With the assistance of ENISA, the Commission shall chair the ECCG, and the Commission shall provide the ECCG with a secretariat in accordance with point (e) of Article 8(1). Article 63 Right to lodge a complaint 1. Natural and legal persons shall have the right to lodge a complaint with the issuer of a European cybersecurity certificate or, where the complaint relates to a European cybersecurity certificate issued by a conformity assessment body when acting in accordance with Article 56(6), with the relevant national cybersecurity certification authority. 2. The authority or body with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken, and shall inform the complainant of the right to an effective judicial remedy referred to in Article 64. Article 64 Right to an effective judicial remedy 1. Notwithstanding any administrative or other non-judicial remedies, natural and legal persons shall have the right to an effective judicial remedy with regard to: (a) decisions taken by the authority or body referred to in Article 63(1) including, where applicable, in relation to the improper issuing, failure to issue or recognition of a European cybersecurity certificate held by those natural and legal persons; (b) a failure to act on a complaint lodged with the authority or body referred to in Article 63(1). 2. Proceedings pursuant to this Article shall be brought before the courts of the Member State in which the authority or body against which the judicial remedy is sought is located. Article 65 Penalties Member States shall lay down the rules on penalties applicable to infringements of this Title and to infringements of European cybersecurity certification schemes, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall without delay notify the Commission of those rules and of those measures and shall notify it of any subsequent amendment affecting them. TITLE IV FINAL PROVISIONS Article 66 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, point (b) of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 67 Evaluation and review 1. By 28 June 2024, and every five years thereafter, the Commission shall evaluate the impact, effectiveness and efficiency of ENISA and of its working practices, the possible need to modify ENISA\u2019s mandate and the financial implications of any such modification. The evaluation shall take into account any feedback provided to ENISA in response to its activities. Where the Commission considers that the continued operation of ENISA is no longer justified in light of the objectives, mandate and tasks assigned to it, the Commission may propose that this Regulation be amended with regard to the provisions related to ENISA. 2. The evaluation shall also assess the impact, effectiveness and efficiency of the provisions of Title III of this Regulation with regard to the objectives of ensuring an adequate level of cybersecurity of ICT products, ICT services and ICT processes in the Union and improving the functioning of the internal market. 3. The evaluation shall assess whether essential cybersecurity requirements for access to the internal market are necessary in order to prevent ICT products, ICT services and ICT processes which do not meet basic cybersecurity requirements from entering the Union market. 4. By 28 June 2024, and every five years thereafter, the Commission shall transmit a report on the evaluation together with its conclusions to the European Parliament, to the Council and to the Management Board. The findings of that report shall be made public. Article 68 Repeal and succession 1. Regulation (EU) No 526/2013 is repealed with effect from 27 June 2019. 2. References to Regulation (EU) No 526/2013 and to the ENISA as established by that Regulation shall be construed as references to this Regulation and to ENISA as established by this Regulation. 3. ENISA as established by this Regulation shall succeed ENISA as established by Regulation (EU) No 526/2013 as regards all ownership, agreements, legal obligations, employment contracts, financial commitments and liabilities. All decisions of the Management Board and the Executive Board adopted in accordance with Regulation (EU) No 526/2013 shall remain valid, provided that they comply with this Regulation. 4. ENISA shall be established for an indefinite period as of 27 June 2019. 5. The Executive Director appointed pursuant to Article 24(4) of Regulation (EU) No 526/2013 shall remain in office and exercise the duties of the Executive Director as referred to in Article 20 of this Regulation for the remaining part of the Executive Director\u2019s term of office. The other conditions of his or her contract shall remain unchanged. 6. The members of the Management Board and their alternates appointed pursuant to Article 6 of Regulation (EU) No 526/2013 shall remain in office and exercise the functions of the Management Board as referred to in Article 15 of this Regulation for the remaining part of their term of office. Article 69 Entry into force 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. Articles 58, 60, 61, 63, 64 and 65 shall apply from 28 June 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 17 April 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 227, 28.6.2018, p. 86. (2) OJ C 176, 23.5.2018, p. 29. (3) Position of the European Parliament of 12 March 2019 (not yet published in the Official Journal) and decision of the Council of 9 April 2019. (4) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (5) Regulation (EU) No 526/2013 of the European Parliament and of the Council of 21 May 2013 concerning the European Union Agency for Network and Information Security (ENISA) and repealing Regulation (EC) No 460/2004 (OJ L 165, 18.6.2013, p. 41). (6) Regulation (EC) No 460/2004 of the European Parliament and of the Council of 10 March 2004 establishing the European Network and Information Security Agency (OJ L 77, 13.3.2004, p. 1). (7) Regulation (EC) No 1007/2008 of the European Parliament and of the Council of 24 September 2008 amending Regulation (EC) No 460/2004 establishing the European Network and Information Security Agency as regards its duration (OJ L 293, 31.10.2008, p. 1). (8) Regulation (EU) No 580/2011 of the European Parliament and of the Council of 8 June 2011 amending Regulation (EC) No 460/2004 establishing the European Network and Information Security Agency as regards its duration (OJ L 165, 24.6.2011, p. 3). (9) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). (10) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (11) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (12) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36). (13) Decision 2004/97/EC, Euratom taken by common agreement between the Representatives of the Member States, meeting at Head of State or Government level, of 13 December 2003 on the location of the seats of certain offices and agencies of the European Union (OJ L 29, 3.2.2004, p. 15). (14) OJ C 12, 13.1.2018, p. 1. (15) Commission Recommendation (EU) 2017/1584 of 13 September 2017 on coordinated response to large-scale cybersecurity incidents and crises (OJ L 239, 19.9.2017, p. 36). (16) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (17) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (18) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (19) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (20) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (21) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (22) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (23) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73). (24) OJ L 56, 4.3.1968, p. 1. (25) Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (OJ L 328, 7.12.2013, p. 42). (26) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). (27) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (28) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (29) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (30) OJ L 136, 31.5.1999, p. 15. (31) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (32) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385/58). ANNEX REQUIREMENTS TO BE MET BY CONFORMITY ASSESSMENT BODIES Conformity assessment bodies that wish to be accredited shall meet the following requirements: 1. A conformity assessment body shall be established under national law and shall have legal personality. 2. A conformity assessment body shall be a third-party body that is independent of the organisation or the ICT products, ICT services or ICT processes that it assesses. 3. A body that belongs to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of ICT products, ICT services or ICT processes which it assesses may be considered to be a conformity assessment body, provided that its independence and the absence of any conflict of interest are demonstrated. 4. The conformity assessment bodies, their top-level management and the persons responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the ICT product, ICT service or ICT process which is assessed, or the authorised representative of any of those parties. That prohibition shall not preclude the use of the ICT products assessed that are necessary for the operations of the conformity assessment body or the use of such ICT products for personal purposes. 5. The conformity assessment bodies, their top-level management and the persons responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of the ICT products, ICT services or ICT processes which are assessed, or represent parties engaged in those activities. The conformity assessment bodies, their top-level management and the persons responsible for carrying out the conformity assessment tasks shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to their conformity assessment activities. That prohibition shall apply, in particular, to consultancy services. 6. If a conformity assessment body is owned or operated by a public entity or institution, the independence and absence of any conflict of interest shall be ensured between the national cybersecurity certification authority and the conformity assessment body, and shall be documented. 7. Conformity assessment bodies shall ensure that the activities of their subsidiaries and subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. 8. Conformity assessment bodies and their staff shall carry out conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field, and shall be free from all pressures and inducements which might influence their judgement or the results of their conformity assessment activities, including pressures and inducements of a financial nature, especially as regards persons or groups of persons with an interest in the results of those activities. 9. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it under this Regulation, regardless of whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. Any subcontracting to, or consultation of, external staff shall be properly documented, shall not involve any intermediaries and shall be subject to a written agreement covering, among other things, confidentiality and conflicts of interest. The conformity assessment body in question shall take full responsibility for the tasks performed. 10. At all times and for each conformity assessment procedure and each type, category or sub-category of ICT products, ICT services or ICT processes, a conformity assessment body shall have at its disposal the necessary: (a) staff with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) descriptions of procedures in accordance with which conformity assessment is to be carried out, to ensure the transparency of those procedures and the possibility of reproducing them. It shall have in place appropriate policies and procedures that distinguish between tasks that it carries out as a body notified pursuant to Article 61 and its other activities; (c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the ICT product, ICT service or ICT process in question and the mass or serial nature of the production process. 11. A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner, and shall have access to all necessary equipment and facilities. 12. The persons responsible for carrying out conformity assessment activities shall have the following: (a) sound technical and vocational training covering all conformity assessment activities; (b) satisfactory knowledge of the requirements of the conformity assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding of the applicable requirements and testing standards; (d) the ability to draw up certificates, records and reports demonstrating that conformity assessments have been carried out. 13. The impartiality of the conformity assessment bodies, of their top-level management, of the persons responsible for carrying out conformity assessment activities, and of any subcontractors shall be guaranteed. 14. The remuneration of the top-level management and of the persons responsible for carrying out conformity assessment activities shall not depend on the number of conformity assessments carried out or on the results of those assessments. 15. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Member State in accordance with its national law, or the Member State itself is directly responsible for the conformity assessment. 16. The conformity assessment body and its staff, its committees, its subsidiaries, its subcontractors, and any associated body or the staff of external bodies of a conformity assessment body shall maintain confidentiality and observe professional secrecy with regard to all information obtained in carrying out their conformity assessment tasks under this Regulation or pursuant to any provision of national law giving effect to this Regulation, except where disclosure is required by Union or Member State law to which such persons are subject, and except in relation to the competent authorities of the Member States in which its activities are carried out. Intellectual property rights shall be protected. The conformity assessment body shall have documented procedures in place in respect of the requirements of this point. 17. With the exception of point 16, the requirements of this Annex shall not preclude exchanges of technical information and regulatory guidance between a conformity assessment body and a person who applies for certification or who is considering whether to apply for certification. 18. Conformity assessment bodies shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of SMEs in relation to fees. 19. Conformity assessment bodies shall meet the requirements of the relevant standard that is harmonised under Regulation (EC) No 765/2008 for the accreditation of conformity assessment bodies performing certification of ICT products, ICT services or ICT processes. 20. Conformity assessment bodies shall ensure that testing laboratories used for conformity assessment purposes meet the requirements of the relevant standard that is harmonised under Regulation (EC) No 765/2008 for the accreditation of laboratories performing testing.", "summary": "The EU Cybersecurity Act The EU Cybersecurity Act SUMMARY OF: Regulation (EU) 2019/881 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification (Cybersecurity Act) WHAT IS THE AIM OF THE REGULATION? It aims to achieve a high level of cybersecurity*, cyber resilience and trust in the European Union (EU) by setting: objectives, tasks and organisational matters for a strengthened and renamed European Union Agency for Cybersecurity (ENISA), with a new permanent mandate; a framework for voluntary European cybersecurity certification schemes for Information and communications technology (ICT) products, services and processes. KEY POINTS ENISA\u2019s mandate is to: achieve a high common level of cybersecurity across the EU; support national authorities and EU institutions, bodies, offices and agencies in improving cybersecurity; serve as a reference point for scientific and technical advice and expertise on cybersecurity for EU institutions, bodies, offices and agencies, as well as for other relevant stakeholders; contribute to reducing the fragmentation of the internal market; act independently, avoid duplicating national activities and take account of national expertise; develop its own technical, human and skill resources. ENISA\u2019s tasks are to: help develop and implement EU policy and law; promote capacity-building, for instance, through improved prevention, detection and analysis of, and response to, cyber threats* and by assisting the development of national computer security incident response teams (CSIRTs), or through the organisation of cybersecurity exercises at EU level; support EU operational cooperation among all actors involved, including the EU\u2019s Computer Emergency Response Team (CERT-EU), by means of, notably, exchange of know-how and best practices, supply of relevant guidelines and servicing of the EU and national CSIRTs network; support and promote the development and implementation of EU cybersecurity certification of ICT products, services and processes, as part of the role in preparing schemes under the new European cybersecurity certification framework; collect and analyse knowledge and information on cybersecurity, like notably on emerging technologies, cyber threats and incidents, to provide information and advice for national authorities, relevant stakeholders and, through a dedicated portal, to the public (citizens, organisations and businesses); raise public awareness of cybersecurity risks and provide good practices guidance for individual users and promote cybersecurity awareness and education in general; advise on research needs and priorities and contribute to the EU\u2019s strategic cybersecurity research and innovation agenda; contribute to the EU\u2019s efforts to cooperate on cybersecurity with its international partners and organisations. ENISA has the following administrative and management structure: a Management Board. With 1 representative from each EU country and two members appointed by the European Commission; it establishes the general direction of the agency\u2019s activities and ensures that the Agency carries out its tasks under conditions which enable it to serve in accordance with the founding regulation; an Executive Board of 5 members, which prepares decisions to be adopted by the Management Board; an independent Executive Director, accountable to the Management Board and reporting to the European Parliament and the Council when asked to do so, is responsible for managing the Agency; an ENISA Advisory Group of recognised experts from relevant stakeholders such as the ICT industry, providers of electronic communications networks or services, SMEs, consumers, academics, operators of essential services, as well as representatives of competent authorities notified under the European Electronic Communications Code, standardisation organisations, law enforcement and data protection supervisory authorities, focuses on issues relevant to stakeholders and brings them to the attention of ENISA; a National Liaison Officers Network composed of representatives of all EU countries facilitates the exchange of information between ENISA and the EU countries and supports ENISA in making its activities, findings and recommendations widely known. The regulation creates the following: a Stakeholder Cybersecurity Certification Group of recognised experts to, for instance, advise the Commission on strategic issues regarding the EU cybersecurity certification framework and, upon request, ENISA on general and strategic issues concerning the Agency's relevant tasks; a European Cybersecurity Certification Group (ECCG) composed of national representatives to advise and assist the Commission in its work to ensure the consistent implementation and application of the Act, and ENISA in relation to the preparation of candidate cybersecurity certification schemes. ENISA: is established for an indefinite period as of 27 June 2019; operates according to a single programming document containing its annual and multiannual programming; follows the Commission\u2019s security rules to protect sensitive non-classified information and EU classified information; does not divulge to third parties confidential information it processes or receives; participates fully in EU measures to combat fraud, corruption and other unlawful activities; processes personal data in accordance with respective EU rules. The regulation establishes a European cybersecurity certification framework to: improve the functioning of the internal market by increasing the level of cybersecurity in the EU and enabling a harmonised approach at EU level to European cybersecurity certification schemes with a view to creating a digital single market for ICT products, services and processes; set up a mechanism to establish certification schemes that confirm ICT products, services and processes that have been evaluated in accordance with such schemes comply with specified security requirements to protect the availability, authenticity, integrity or confidentiality of stored, transmitted or processed data or functions or services offered by, or accessible via, those products, services and processes throughout their life cycle. Under the framework: The Commission: publishes an EU rolling work programme for European cybersecurity certification identifying strategic priorities and ICT products, services and processes or categories which could benefit from a scheme;may request ENISA to prepare a candidate certification scheme or review an existing one. ENISA: prepares suitable draft schemes, following a request from the Commission or the ECCG;evaluates each adopted certification scheme every 5 years, taking account of the feedback received;maintains a dedicated website providing information on the schemes, certificates and conformity statements. The voluntary European cybersecurity certification schemes: aim to achieve various security objectives, such as protecting stored, transmitted and processed data; denote the security level of ICT products, services and processes as \u2018basic\u2019, \u2018substantial\u2019 or \u2018high\u2019; allow manufacturers and providers of low-risk (i.e. \u2018basic\u2019) ICT products, services and processes to assess these themselves (\u2018conformity self-assessment\u2019); must include certain features, such as clear descriptions of purpose, subject matter and scope and the evaluation criteria and methods used; replace similar national ones, although those certificates remain valid until their expiry date. Manufacturers and providers of certified ICT products, services or processes must make publicly available: guidance and recommendations to help end users install, apply and maintain their products or services; the duration they offer security support; their contact details; references to online repositories with information on known cybersecurity issues affecting their products or services. EU countries appoint one or more national cybersecurity certification authorities with sufficient resources and powers to monitor, supervise and enforce the rules of the European certification schemes. The Commission: regularly assesses the efficiency and use of the adopted certification schemes and considers whether any scheme should be made compulsory; completes its first detailed assessment by 31 December 2023, with others every 2 years; evaluates ENISA\u2019s impact, effectiveness and efficiency by 28 June 2024 and every 5 years thereafter. Individuals and legal entities have the right to lodge a complaint with the issuer of a European cybersecurity certificate and to seek effective judicial remedy. The regulation does not affect EU countries\u2019 responsibilities for public security, defence, national security and criminal law. The regulation repeals Regulation (EU) No 526/2013 from 27 June 2019. FROM WHEN DOES THE REGULATION APPLY? The regulation has applied since 27 June 2019. Articles on the designation of national cybersecurity authorities, accreditation and notification of conformity assessment bodies, the right to lodge complaints to issuers of European cybersecurity certificates and the right to judicial remedy as well as on penalties, apply from 28 June 2021. BACKGROUND ENISA, based in Athens with a branch office in Heraklion, has been contributing to the EU\u2019s network and information security since 2004. For more information, see: ENISA \u2014 European Union Agency for Cybersecurity (ENISA) Cybersecurity (European Commission). KEY TERMS Cybersecurity: the activities necessary for the protection of network and information systems, their users and others affected by cyber threats. Cyber threat: a potential circumstance, event or action that could damage, disrupt or adversely affect network and information systems, their users and others. MAIN DOCUMENT Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, pp. 15-69) RELATED DOCUMENTS Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, pp. 39-98) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, pp. 1-30) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) Successive amendments to Regulation (EU) 2016/679 have been incorporated into the original text. This consolidated version is of documentary value only. last update 10.03.2020"}
{"article": "29.3.2019 EN Official Journal of the European Union L 91/19 REGULATION (EU) 2019/516 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 19 March 2019 on the harmonisation of gross national income at market prices and repealing Council Directive 89/130/EEC, Euratom and Council Regulation (EC, Euratom) No 1287/2003 (GNI Regulation) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 338(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Gross national income at market prices (GNI) constitutes the basis for calculating the largest share of own resources in the general budget of the Union. Therefore, it is necessary to further reinforce the comparability, reliability and exhaustiveness of that aggregate. (2) Statistical integrity through respect for the principles of the European Statistics Code of Practice, as reviewed and updated by the European Statistical System Committee (ESSC) on 16 November 2017, and of Regulation (EC) No 223/2009 of the European Parliament and of the Council (2) is of particular importance where statistics are being used directly for administrative purposes and for policy-making at Union and national levels. (3) Those statistical data are also an important analytical tool for the coordination of national economic policies and for various Union policies, as well as for research activities. (4) In accordance with Article 2(7) of Council Decision 2014/335/EU, Euratom (3), for own resources purposes, GNI means an annual GNI at market prices under the methodology set out in Annex A to Regulation (EU) No 549/2013 of the European Parliament and of the Council (4) which established the revised European System of Accounts (ESA 2010). In accordance with Article 10(1) of Decision 2014/335/EU, Euratom, and subject to Article 10(2) thereof, Council Decision 2007/436/EC, Euratom (5) was repealed. (5) It is essential that GNI data be comparable across Member States and that there be compliance with the relevant definitions and accounting rules of ESA 2010. For that purpose, the assessment procedures and the basic data actually used should permit the correct application of the definitions and accounting rules of ESA 2010. (6) It is essential that the sources and methods used to compile GNI data be reliable. This means that sound techniques should be applied to robust, suitable and up-to-date basic statistics as much as possible. (7) It is essential that GNI data be exhaustive. Therefore, those data should also take into account informal, unregistered and other activities and transactions that are not reported in statistical surveys or to fiscal, social and other administrative authorities. Improved GNI coverage presupposes developing suitable statistical bases and assessment procedures in order to produce reliable statistics and, where applicable, to make necessary adjustments, avoiding gaps and double counting. (8) Council Regulation (EU, Euratom) No 608/2014 (6) provides for inspections in Member States for the purpose of verifying own resources. For GNI verification purposes, the Commission (Eurostat) should be entitled to carry out GNI information visits in order to verify the quality of GNI aggregates and their components and to verify compliance with ESA 2010, as well as to ensure that GNI data are comparable, reliable and exhaustive. The Commission (Eurostat) should respect rules on statistical confidentiality. The participation of representatives of national statistical authorities in GNI information visits to other Member States is essential in order to increase the transparency and quality of the process of GNI verification. (9) In order to ensure the reliability, exhaustiveness and highest possible degree of comparability of GNI data, in line with ESA 2010, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the list of issues to be addressed in every verification cycle. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (7). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (10) In order to ensure uniform conditions for the implementation of this Regulation by providing GNI aggregates for own resources purposes, implementing powers should be conferred on the Commission to establish the structure and detailed arrangements of the inventory of the sources and methods used to produce GNI data and their components, in accordance with Annex A to Regulation (EU) No 549/2013, as well as the timetable for its updating and transmission, and the specific measures aimed at improving the comparability, reliability and exhaustiveness of Member States' GNI data based on the list of issues defined by the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (8). (11) The ESSC, established by Regulation (EC) No 223/2009, has been, in accordance with Article 7 of that Regulation, asked to provide its professional guidance. (12) The GNI Committee referred to in Article 4 of Council Regulation (EC, Euratom) No 1287/2003 (9) has issued opinions for, provided advice to, and assisted the Commission in the exercise of its implementing powers. Under the strategy for a new European Statistical System structure to improve coordination and partnership in a clear pyramid structure within the System, the ESSC should have an advisory role and assist the Commission in exercising its implementing powers. To that effect, the GNI Committee should be replaced by the ESSC for the purpose of assisting the Commission in the exercise of its implementing powers under this Regulation. Nevertheless, for the purposes of other functions previously undertaken by the GNI Committee under Regulation (EC, Euratom) No 1287/2003, and not relating to assistance in the exercise of the implementing powers of the Commission, the Commission should establish a formal expert group to assist it for such purposes. (13) Council Directive 89/130/EEC, Euratom (10) and Regulation (EC, Euratom) No 1287/2003 set up a procedure to verify and assess the comparability, reliability and exhaustiveness of Gross National Product (GNP) data and GNI data within the GNP Committee and GNI Committee in which Member States and the Commission cooperate closely. That procedure should be adjusted to take account of the use of GNI data according to ESA 2010 for the purposes of own resources, the revised timetable for making available own resources, and recent developments within the European Statistical System. Directive 89/130/EEC, Euratom and Regulation (EC, Euratom) No 1287/2003 should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I DEFINITION AND CALCULATION OF GROSS NATIONAL INCOME AT MARKET PRICES Article 1 1. Gross national income at market prices (GNI) and gross domestic product at market prices (GDP) shall be defined in accordance with the European System of Accounts 2010 (ESA 2010) established by Regulation (EU) No 549/2013. 2. In accordance with point 8.89 of Annex A to Regulation (EU) No 549/2013, GDP means the final result of the production activity of resident producer units. It can be defined in three ways: (a) production approach: GDP is the sum of gross value added of the various institutional sectors or the various industries plus taxes and less subsidies on products (which are not allocated to sectors and industries). It is also the balancing item in the total economy production account; (b) expenditure approach: GDP is the sum of final uses of goods and services by resident institutional units (final consumption and gross capital formation) plus exports and minus imports of goods and services; (c) income approach: GDP is the sum of uses in the total economy generation of income account (compensation of employees, taxes on production and imports less subsidies, gross operating surplus and mixed income of the total economy). 3. In accordance with point 8.94 of Annex A to Regulation (EU) No 549/2013, GNI means the total primary income receivable by resident institutional units: compensation of employees, taxes on production and imports less subsidies, property income (receivable less payable), gross operating surplus and gross mixed income. GNI equals GDP minus primary income payable by resident institutional units to non-resident institutional units plus primary income receivable by resident institutional units from the rest of the world. CHAPTER II TRANSMISSION OF GNI DATA AND ADDITIONAL INFORMATION Article 2 1. Member States shall calculate GNI as defined in Article 1 in the context of national accounts compilation. 2. Before 1 October each year, Member States shall provide the Commission (Eurostat), in the context of national accounting procedures, with figures for GNI aggregates and their components, in accordance with the definitions referred to in Article 1. Totals for GDP and its components shall be presented in accordance with the three approaches referred to in Article 1(2). Data shall be transmitted for the preceding year and any changes made to the data for previous years shall be communicated at the same time. 3. The transmission of data referred to in paragraph 2 shall be accompanied by a report on the quality of GNI data. That report shall detail the methodology used to produce the data, and in particular describe any significant changes in the sources and methods used and explain the revisions made to GNI aggregates and their components compared to the previous periods. Article 3 1. Member States shall provide the Commission (Eurostat) with an inventory of the sources and methods used to produce GNI aggregates and their components in accordance with ESA 2010. 2. The Commission shall establish, by means of implementing acts, the structure and detailed arrangements of the inventory referred to in paragraph 1 of this Article, in accordance with Annex A to Regulation (EU) No 549/2013, as well as the timetable for its updating and transmission. In exercising its power, the Commission shall ensure that such implementing acts do not impose significant additional costs which result in a disproportionate and unjustified burden on the Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 8(2) of this Regulation. The inventory shall be consistent with ESA 2010 and duplication and overloading shall be avoided. 3. To facilitate comparable analyses of compliance, the Commission shall draw up an inventory guide in close cooperation with the expert group referred to in Article 4. CHAPTER III PROCEDURES AND CHECKS ON THE CALCULATION OF GNI Article 4 The Commission shall establish a formal expert group, composed of representatives of all the Member States and chaired by a representative of the Commission, to advise the Commission on, and to express its views regarding, the comparability, reliability and exhaustiveness of GNI calculations, to examine issues of implementation of this Regulation and to issue annual opinions on the appropriateness of the GNI data submitted by the Member States for own resources purposes. Article 5 1. The Commission shall verify the sources, their uses and the methods in the inventory referred to in Article 3(1). A verification model, drawn up by the Commission in close cooperation with the expert group referred to in Article 4, shall be used to that effect. The model shall be based on the principles of peer review and cost-effectiveness and shall take into account the delegated acts referred to in the second subparagraph of paragraph 2 of this Article. 2. GNI data shall be reliable, exhaustive and comparable. The Commission shall adopt delegated acts in accordance with Article 7 to supplement the provision laid down in the first subparagraph of this paragraph by defining the list of issues to be addressed in every verification cycle to ensure the reliability, exhaustiveness and highest possible degree of comparability of GNI data, in line with ESA 2010. 3. The Commission shall establish, by means of implementing acts, specific measures to make GNI data more comparable, reliable and exhaustive, based on the list of issues defined by the Commission in the delegated acts referred to in the second subparagraph of paragraph 2 of this Article. Such implementing acts shall be duly justified and in accordance with ESA 2010. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 8(2). Article 6 1. Without prejudice to the inspections provided for in Article 2 of Regulation (EU, Euratom) No 608/2014, GNI information visits may, where deemed appropriate, be carried out in Member States by the Commission (Eurostat). 2. The purposes of the information visits referred to in paragraph 1 of this Article shall be the verification of the quality of GNI aggregates and their components and the verification of compliance with ESA 2010. In exercising its right to carry out such information visits, the Commission (Eurostat) shall respect the rules on statistical confidentiality laid down in Chapter V of Regulation (EC) No 223/2009. 3. When carrying out information visits in Member States, the Commission (Eurostat) may and is encouraged to request the assistance of national accounts experts representing national statistical authorities of other Member States. The national accounts experts shall be registered on a list constituted on the basis of voluntary proposals sent to the Commission (Eurostat) by the national authorities responsible for the reporting of national accounts.The participation of national accounts experts of other Member States in those information visits is voluntary. Article 7 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in the second subparagraph of Article 5(2) shall be conferred on the Commission for a period of 5 years from 18 April 2019. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in the second subparagraph of Article 5(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to the second subparagraph of Article 5(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 8 1. The Commission shall be assisted by the European Statistical System Committee established by Regulation (EC) No 223/2009. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. CHAPTER IV FINAL PROVISIONS Article 9 Before 1 January 2023, the Commission shall present a report to the European Parliament and to the Council on the application of this Regulation. Article 10 Directive 89/130/EEC, Euratom and Regulation (EC, Euratom) No 1287/2003 are repealed. References to the repealed acts shall be construed as references to this Regulation and shall be read in accordance with the correlation tables in the Annex. Article 11 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 19 March 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) Position of the European Parliament of 31 January 2019 (not yet published in the Official Journal) and decision of the Council of 18 February 2019. (2) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (3) Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (OJ L 168, 7.6.2014, p. 105). (4) Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union (OJ L 174, 26.6.2013, p. 1). (5) Council Decision 2007/436/EC, Euratom of 7 June 2007 on the system of the European Communities' own resources (OJ L 163, 23.6.2007, p. 17). (6) Council Regulation (EU, Euratom) No 608/2014 of 26 May 2014 laying down implementing measures for the system of own resources of the European Union (OJ L 168, 7.6.2014, p. 29). (7) OJ L 123, 12.5.2016, p. 1. (8) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (9) Council Regulation (EC, Euratom) No 1287/2003 of 15 July 2003 on the harmonisation of gross national income at market prices (GNI Regulation) (OJ L 181, 19.7.2003, p. 1). (10) Council Directive 89/130/EEC, Euratom of 13 February 1989 on the harmonisation of the compilation of gross national product at market prices (OJ L 49, 21.2.1989, p. 26). ANNEX Correlation tables Directive 89/130/EEC, Euratom This Regulation Article 1 Article 1(1) and (3) Article 2 Article 1(2) Article 3 Article 2(1) and (2) \u2014 Article 4 Article 4 Article 3 Article 5 Article 2(3) \u2014 Article 5 \u2014 Article 6 \u2014 Article 7 Article 6 Article 8 Article 7 \u2014 Article 8 \u2014 Article 9 \u2014 Article 10 Article 9 \u2014 Article 10 Article 11 \u2014 \u2014 Article 11 Regulation (EC, Euratom) No 1287/2003 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 Article 3 \u2014 Article 4 Article 4 Article 8 Article 5(1) Article 5 Article 5(2) \u2014 Article 5(3) \u2014 Article 6 Article 6 \u2014 Article 7 Article 7 Article 9 \u2014 Article 10 Article 8 Article 11", "summary": "Harmonising gross national income statistics at European Union level Harmonising gross national income statistics at European Union level SUMMARY OF: Regulation (EU) 2019/516 on the harmonisation of gross national income at market prices WHAT IS THE AIM OF THE REGULATION? It aims to improve the comparability, reliability and exhaustiveness of statistics on gross national income at market prices (GNI) *. These statistics are used especially to calculate the largest share of own resources in the budget of the European Union (EU). It takes account of: the legal basis for producing statistics (Article 338(1) of the Treaty on the Functioning of the European Union); the own resources decision (Decision 2014/335/EU, Euratom) and related legislation; Regulation (EU) No 549/2013 setting up the EU\u2019s system of national and regional accounts (known as ESA 2010). It repeals Directive 89/130/EEC and Regulation (EC, Euratom) No 1287/2003. KEY POINTS Definitions The regulation requires that GNI and gross domestic product at market prices (GDP) * be defined in accordance with ESA 2010. Transmission of data and additional information to the European Commission EU Member States have to: calculate GNI; before 1 October each year, provide the Commission\u2019s statistical office (Eurostat) with data relating to the preceding year and any changes made to the data for previous years, such as: figures for GNI aggregates and their components, totals for GDP and its components (according to the three approaches); accompany these data with a report on the quality of GNI data detailing the methodology used to produce the data, and in particular describing any significant changes in the sources and methods used and explaining the revisions made to GNI aggregates and their components compared to previous periods; provide Eurostat with an inventory of the sources and methods used to produce GNI aggregates and their components. Procedures and checks on the calculation of GNI An expert group, set up by Commission Decision, comprising representatives from the Member States, has been set up to: advise the Commission on the comparability, reliability and exhaustiveness of GNI calculations; examine implementation aspects of this regulation; issue annual opinions on the quality of the GNI data submitted by the Member States for own resource purposes. With regard to the inventories provided by the Member States, the Commission will verify the sources and their uses and methods, including by carrying out information visits. Implementing and delegated acts The regulation gives the Commission powers to adopt: delegated acts setting out the list of issues to be addressed in every verification cycle in order to ensure the reliability, exhaustiveness and highest possible degree of comparability of GNI data, in line with ESA 2010; specific implementing acts to make GNI data more comparable, reliable and exhaustive, based on the list of issues set out in the delegated acts. In October 2020, the Commission adopted Implementing Regulation (EU) 2020/1546 , which sets out the structure and detailed arrangements of the inventory of the sources and methods used to produce GNI aggregates and their components in accordance with ESA 2010. In November 2021, the Commission adopted: Implementing Regulation (EU) 2021/1947 defining the geographic territory of Member States for the purposes of Regulation (EU) 2019/516; Implementing Regulation (EU) 2021/1948 on the treatment of repayments of value added tax to non-taxable persons and to taxable persons for their exempt activities for the purposes of Regulation (EU) 2019/516; Implementing Regulation (EU) 2021/1949 on the principles for estimating dwelling services for the purposes of Regulation (EU) 2019/516. European Statistical System Committee Eurostat is assisted and advised by the European Statistical System Committee, which is composed of representatives from Member States and chaired by the Commission. Report Before 1 January 2023, the Commission will report to the European Parliament and the Council of the European Union on the regulation\u2019s application. FROM WHEN DOES THE REGULATION APPLY? It has applied since 18 April 2019. BACKGROUND For further information, see: Gross national income (Eurostat). KEY TERMS Gross national income at market prices (GNI): The total primary income receivable by resident institutional units: compensation of employees, taxes on production and imports less subsidies, property income (receivable less payable), gross operating surplus and gross mixed income. GNI equals GDP minus primary income payable by resident institutional units to non-resident institutional units plus primary income receivable by resident institutional units from the rest of the world. Gross domestic product at market prices (GDP): This can be defined in three ways. 1. Production approach. GDP is the sum of gross value added of the various institutional sectors or the various industries plus taxes and less subsidies on products (which are not allocated to sectors and industries). It is also the balancing item in the total economy production account. 2. Expenditure approach. GDP is the sum of final uses of goods and services by resident institutional units (final consumption and gross capital formation) plus exports and minus imports of goods and services. 3. Income approach. GDP is the sum of uses in the total economy generation of income account (compensation of employees, taxes on production and imports less subsidies, gross operating surplus and mixed income of the total economy). MAIN DOCUMENT Regulation (EU) 2019/516 of the European Parliament and of the Council of 19 March 2019 on the harmonisation of gross national income at market prices and repealing Council Directive 89/130/EEC, Euratom and Council Regulation (EC, Euratom) No 1287/2003 (GNI Regulation) (OJ L 91, 29.3.2019, pp. 19\u201324). RELATED DOCUMENTS Commission Implementing Regulation (EU) 2021/1947 of 10 November 2021 on the definition of the geographic territory of Member States for the purposes of Regulation (EU) 2019/516 of the European Parliament and of the Council on the harmonisation of gross national income at market prices (GNI Regulation) and repealing Commission Decision 91/450/EEC, Euratom and Commission Regulation (EC) No 109/2005 (OJ L 398, 11.11.2021, pp. 1\u20133). Commission Implementing Regulation (EU) 2021/1948 of 10 November 2021 on the treatment of repayments of value added tax to non-taxable persons and to taxable persons for their exempt activities for the purposes of Regulation (EU) 2019/516 of the European Parliament and of the Council on the harmonisation of gross national income at market prices (GNI Regulation) and repealing Commission Decision 1999/622/EC, Euratom and Commission Regulation (EC, Euratom) No 116/2005 (OJ L 398, 11.11.2021, pp. 4\u20135). Commission Implementing Regulation (EU) 2021/1949 of 10 November 2021 on the principles for estimating dwelling services for the purposes of Regulation (EU) 2019/516 of the European Parliament and of the Council on the harmonisation of gross national income at market prices (GNI Regulation) and repealing Commission Decision 95/309/EC, Euratom and Commission Regulation (EC) No 1722/2005 (OJ L 398, 11.11.2021, pp. 6\u201318). Council Regulation (EU, Euratom) 2021/768 of 30 April 2021 laying down implementing measures for the system of own resources of the European Union and repealing Regulation (EU, Euratom) No 608/2014 (OJ L 165, 11.5.2021, pp. 1\u20138). Commission Implementing Regulation (EU) 2020/1546 of 23 October 2020 establishing the structure and detailed arrangements of the inventory of the sources and methods used to produce gross national income aggregates and their components in accordance with the European System of Accounts (ESA 2010) (OJ L 354, 26.10.2020, pp. 1\u20133). Commission Decision of 17 May 2019 setting up the Commission expert group on gross national income (OJ C 174, 21.5.2019, pp. 5\u20138). Consolidated version of the Treaty on the Functioning of the European Union \u2013 Part Seven \u2013 General and final provisions \u2013 Article 338 (ex Article 285 TEC) (OJ C 202, 7.6.2016, pp. 192\u2013193). Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (OJ L 168, 7.6.2014, pp. 105\u2013111). Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union (OJ L 174, 26.6.2013, pp. 1\u2013727). Successive amendments to Regulation (EU) No 549/2013 have been incorporated into the original document. This consolidated version is of documentary value only. Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, pp. 164\u2013173). See consolidated version. last update 11.02.2022"}
{"article": "10.1.2019 EN Official Journal of the European Union LI 8/1 REGULATION (EU) 2019/26 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 January 2019 complementing Union type-approval legislation with regard to the withdrawal of the United Kingdom from the Union (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) On 29 March 2017, the United Kingdom submitted the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (TEU). The Treaties will cease to apply to the United Kingdom from the date of entry into force of the withdrawal agreement or, failing that, two years after that notification, i.e. from 30 March 2019, unless the European Council, in agreement with the United Kingdom, unanimously decides to extend that period. (2) The withdrawal agreement as agreed between the negotiators contains arrangements allowing for the application of provisions of Union law to and in the United Kingdom beyond the date that the Treaties cease to apply to and in the United Kingdom. If that agreement enters into force, the Union type-approval legislation will apply to and in the United Kingdom during the transition period in accordance with that agreement and will cease to apply at the end of that period. (3) A comprehensive Union type-approval legislative framework was established by Directive 2007/46/EC of the European Parliament and of the Council (3), Regulation (EU) No 167/2013 of the European Parliament and of the Council (4), Regulation (EU) No 168/2013 of the European Parliament and of the Council (5) and Regulation (EU) 2016/1628 of the European Parliament and of the Council (6). (4) Those acts leave to manufacturers the choice of the type-approval authority from which to obtain a type-approval that allows them to place on the Union market vehicles, systems, components and separate technical units. (5) The withdrawal of the United Kingdom from the Union would, in the absence of any special provisions, have the effect that EC type-approvals and EU type-approvals previously granted by the type-approval authority of the United Kingdom (\u2018UK type-approval authority\u2019), in accordance with regulatory acts of the Union, could no longer ensure access to the Union market. Such type-approvals are also held by manufacturers established within the Member States other than the United Kingdom. While vehicles, systems, components and separate technical units type-approved by the United Kingdom, in accordance with regulatory acts of the Union can be placed on the Union market until Union type-approval legislation ceases to apply to and in the United Kingdom, it is necessary to establish special provisions for the purposes of facilitating the placing on the Union market of those vehicles, systems, components and separate technical units after that date. (6) Currently, the Union type-approval legislation does not provide for the possibility to re-approve types already approved elsewhere in the Union. However, manufacturers should be able to continue the production of vehicles, systems, components and separate technical units previously based on type-approvals granted by the UK type-approval authority, and to continue to place such vehicles, systems, components and separate technical units on the Union market. It is therefore necessary to allow manufacturers to obtain new type-approvals from type-approval authorities of Member States other than the United Kingdom. (7) This Regulation should also ensure that manufacturers continue to have the greatest possible freedom to choose the new Union type-approval authority. In particular, that choice by the manufacturer should not be dependent on the consent of the UK type-approval authority or the existence of any arrangements between the UK type-approval authority and the new Union type-approval authority. (8) In order to provide the necessary legal certainty for all stakeholders concerned and to ensure a level playing field for manufacturers, it is necessary to lay down, in a transparent manner, equal conditions applicable in all Member States. (9) In order to enable the continued production and placing on the market of vehicles, systems, components and separate technical units, the requirements with which their types are to comply in order to be approved by the type-approval authority of a Member State other than the United Kingdom should be those applicable to the placing on the market of new vehicles, systems, components and separate technical units and not those applicable to new types. (10) The requirements for new vehicles, systems, components and separate technical units are likewise applicable to manufacturers holding type-approvals granted by the Member States other than the United Kingdom. Setting the same requirements for the approval of types under this Regulation as for the placing on the market of new vehicles, systems, components and separate technical units thus aims to ensure equal treatment of manufacturers affected by the withdrawal of the United Kingdom and those holding type-approvals granted by Member States other than the United Kingdom. (11) Nothing in this Regulation should prevent the vehicle manufacturer from applying on a voluntary basis for a Union approval of a vehicle type previously approved in the United Kingdom, on the basis of certain requirements applicable to new types of systems, components or separate technical units, where the type of vehicle remains otherwise identical to the one approved in the United Kingdom. (12) Approvals sought for entirely new types of vehicles, systems, components or separate technical units should not fall within the scope of this Regulation. (13) It should be possible for type-approvals granted on the basis of this Regulation to be based on test reports already presented for the purposes of obtaining the type-approvals in the United Kingdom, where the requirements that form the basis of such test reports have not changed. In order to allow for such continued use of test reports issued by the technical service notified by the United Kingdom, this Regulation should provide for an exemption from the requirement that such technical service must be designated by the authority granting the type-approval and notified by the Member State to the Commission. In order to also cover the time when Union type-approval legislation has ceased to apply to and in the United Kingdom, this Regulation should also provide for an exemption from the specific requirements concerning the designation and notification of technical services of third countries. (14) At the same time, since Union type-approval authorities are to be fully responsible for the new Union type-approvals they grant, they should have the discretion to require new tests to be carried out for any element of the type-approval as they see fit. (15) Insofar as this Regulation does not provide otherwise, the general rules on EC type-approval and EU type-approval should continue to apply. (16) It should be taken into account that the role attributed to type-approval authorities does not end with the production or placing on the market of a vehicle, system, component or a separate technical unit, but extends over several years after the placing on the market of those vehicles, systems, components and separate technical units. This applies in particular with regard to in-service conformity obligations for vehicles falling under Directive 2007/46/EC and with regard to repair and maintenance information obligations and potential recalls for vehicles, systems, components and separate technical units falling under Directive 2007/46/EC, Regulation (EU) No 167/2013, Regulation (EU) No 168/2013 or Regulation (EU) 2016/1628. It is therefore necessary that the authority granting the Union type-approval takes over those obligations also with respect to vehicles, systems, components and separate technical units based on the same type and already placed on the Union market on the basis of the UK type-approval to ensure that there is a responsible type-approval authority. (17) When manufacturers make use of the procedures set out in this Regulation, their UK type-approval may become invalid before Union type-approval legislation ceases to apply to and in the United Kingdom due to the granting of the Union type-approval for the same type. Since manufacturers should not be disadvantaged for having made use of this Regulation, the stock of compliant vehicles, systems, components and separate technical units produced on the basis of a valid UK type-approval should be allowed to be placed on the market, registered and entered into service, once the manufacturers have obtained a new Union type-approval, for as long as Union type-approval legislation continues to apply to and in the United Kingdom, provided that those vehicles, systems, components and separate technical units continue to fulfil the general requirements of the acts listed in Article 1. Since the moments of placing on the market, of registration, and of entry into service can differ, the moment when the first of those steps has been undertaken should be used to determine the time limits set out in this Regulation. (18) It is also necessary that a Union type-approval authority takes over certain obligations with respect to vehicles, systems, components and separate technical units that were placed on the Union market on the basis of UK type-approvals that are either no longer valid pursuant to Article 17 of Directive 2007/46/EC, Article 32 of Regulation (EU) No 167/2013, Article 37 of Regulation (EU) No 168/2013 or Article 30 of Regulation (EU) 2016/1628 or for which no Union type-approval is sought. To ensure that there is a responsible Union type-approval authority, manufacturers should be required to request the Union type-approval authority that is to approve types previously approved in the United Kingdom to assume obligations regarding recalls, repair and maintenance information and in-service conformity checks with respect to their vehicles, systems, components and separate technical unit based on other types and already placed on the Union market. To limit the extent of the obligations taken over by the Union type-approval authority, those obligations should only concern vehicles, systems, components and separate technical units based on UK type-approvals that were granted after 1 January 2008. (19) Decisions of national authorities taken in accordance with Article 27(3) of Directive 2007/46/EC, Article 39(3) of Regulation (EU) No 167/2013 or Article 44(3) of Regulation (EU) No 168/2013 while Union type-approval legislation still applies to and in the United Kingdom, permitting the making available on the market, registration, sale or entry into service of end-of series vehicles conforming to a type whose UK type-approval has become invalid before the day Union type-approval legislation ceases to apply to and in the United Kingdom should remain applicable. (20) The exemptions and transitional provisions applicable to engines or vehicles and non-road mobile machinery in which such engines are installed set out in Article 10(7) of Directive 97/68/EC, Article 34(7) and (8) or Article 58(5) to (11) of Regulation (EU) 2016/1628, and in acts adopted on the basis of Article 19(6), Article 20(8), Article 28(6) and Article 53(12) of Regulation (EU) No 167/2013 allowing the placing on the market of such engines, vehicles and non-road mobile machinery without the requirement of a valid type-approval, should continue to apply. (21) Since the objective of this Regulation, namely to complement Directive 2007/46/EC, Regulation (EU) No 167/2013, Regulation (EU) No 168/2013 and Regulation (EU) 2016/1628 with special rules relating to the withdrawal of the United Kingdom from the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (22) In order to allow manufacturers to take the necessary measures to prepare without delay for the withdrawal of the United Kingdom with regard to Union type-approval legislation, this Regulation should enter into force on the third day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation complements Directive 2007/46/EC, Regulation (EU) No 167/2013, Regulation (EU) No 168/2013 and Regulation (EU) 2016/1628 by establishing special provisions for the EU type-approval and the placing on the market of vehicles, systems, components and separate technical units which have been type-approved by the type-approval authority of the United Kingdom (\u2018UK type-approval authority\u2019) while the Union type-approval legislation referred to in Article 2(1) of this Regulation still applies to and in the United Kingdom. Article 2 Scope 1. This Regulation shall apply to vehicles, systems, components and separate technical units which fall within the scope of Directive 2007/46/EC, Regulation (EU) No 167/2013, Regulation (EU) No 168/2013 or Regulation (EU) 2016/1628 and their types which have been approved by the UK type-approval authority on the basis of those acts or any regulatory act of the Union listed in Annex IV to Directive 2007/46/EC or any regulatory act repealed by those regulatory acts of the Union. 2. References to separate technical units under this Regulation shall be understood as covering references to engines under Regulation (EU) 2016/1628. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018Union type-approval authority\u2019 means a type-approval authority of a Member State other than the United Kingdom; (2) \u2018UK type-approval\u2019 means an EC type-approval or EU type-approval granted by the UK type-approval authority; (3) \u2018Union type-approval\u2019 means an EU type-approval granted by a Union type-approval authority in accordance with this Regulation. Article 4 Application for a Union type-approval 1. By way of derogation from Article 6(6) and Article 7(1) of Directive 2007/46/EC, Article 21(2) of Regulation (EU) No 167/2013, Article 26(2) of Regulation (EU) No 168/2013 and Article 20(1) of Regulation (EU) 2016/1628, a manufacturer holding a UK type-approval that has not become invalid pursuant to Article 17 of Directive 2007/46/EC, Article 32 of Regulation (EU) No 167/2013, Article 37 of Regulation (EU) No 168/2013 or Article 30 of Regulation (EU) 2016/1628 may, until the Union type-approval legislation referred to in Article 2(1) of this Regulation ceases to apply to and in the United Kingdom, submit an application to a Union type-approval authority for a Union type-approval of the same type. 2. In order to be approved, the type must comply with the requirements for the placing on the market, registration or entry into service of new vehicles, systems, components or separate technical units applicable at the time when the Union type-approval takes effect. 3. By submitting the application pursuant to paragraph 1, the manufacturer shall be liable to pay adequate fees, laid down by the Union type-approval authority, for any costs resulting from the exercise of the powers and the fulfilment of the obligations of the Union type-approval authority in relation to the Union type-approval. 4. When submitting the application pursuant to paragraph 1 of this Article, the manufacturer shall, at the request of the Union type-approval authority, submit any documentation and information that the authority deems necessary in order to decide whether to grant a Union type-approval in accordance with Article 5. The documentation and information referred to in the first subparagraph may include the original UK type-approval including all amendments, the information folder and the test reports. In the case of vehicles, such a request may also include any EC type-approval, EU type-approval or UN type-approval and its attachments, as part of the whole vehicle type-approval. Article 5 Conditions for the granting of a Union type-approval and its effects 1. By way of derogation from Article 8(2), Article 9(1) and Article 10(1) and (2) of Directive 2007/46/EC, Article 6(2) of Regulation (EU) No 167/2013, Article 7(2) and Article 18 of Regulation (EU) No 168/2013 and Article 6(2) of Regulation (EU) 2016/1628, the Union type-approval authority which has received an application in accordance with Article 4 of this Regulation may grant a Union type-approval with respect to a vehicle, system, component or separate technical unit if the type in question meets, at the time when the Union type-approval takes effect, the requirements applicable for the placing on the market, registration or entry into service of new vehicles, systems, components or separate technical units. 2. Insofar as no new requirements are applicable and without prejudice to paragraph 3 of this Article, the Union type-approval may be granted on the basis of the same test reports which were previously used for the granting of the UK type-approval in accordance with the applicable provisions, regardless of whether the technical service that issued the test report has been designated and notified by the Member State granting the Union type-approval in accordance with Directive 2007/46/EC, Regulation (EU) No 167/2013, Regulation (EU) No 168/2013 or Regulation (EU) 2016/1628, and even after the Union type-approval legislation referred to in Article 2(1) of this Regulation ceases to apply to and in the United Kingdom. 3. Before granting a Union type-approval, the Union type-approval authority may request the repetition of specific tests. In that case, those tests shall be carried out by a technical service which has been designated and notified by the Member State of the Union type-approval authority in accordance with Directive 2007/46/EC, Regulation (EU) No 167/2013, Regulation (EU) No 168/2013 or Regulation (EU) 2016/1628. 4. The type approved in accordance with paragraph 1 of this Article shall receive an EU type-approval certificate with a number consisting of the distinguishing number of the Member State whose type-approval authority granted the Union type-approval and of the number of the applicable act referred to in Article 2(1). It shall also include the number of the latest amending act containing requirements for type-approval in accordance with which the Union type-approval is granted. For vehicles, the type-approval certificate and the certificate of conformity shall, under \u2018Remarks:\u2019, contain the mention \u2018Previously type-approved as\u2019 and refer to the number and the date of the EU type-approval certificate received following the UK type-approval. For systems, components or separate technical units, the type-approval certificate shall contain the mention \u2018Previously type-approved and marked as\u2019 and refer to the type-approval mark received following the UK type-approval. 5. The Union type-approval shall take effect on the day of its granting or on a later date determined therein. The UK type-approval shall become invalid on the day preceding the day on which the Union type-approval takes effect. In any event, it shall become invalid at the latest on the day on which the Union type-approval legislation referred to in Article 2(1) ceases to apply to and in the United Kingdom. 6. A Union type-approval shall be considered to be an EC type-approval or an EU type-approval within the meaning of Directive 2007/46/EC or any act listed in Annex IV to that Directive, Regulation (EU) No 167/2013, Regulation (EU) No 168/2013 or Regulation (EU) 2016/1628. All provisions of those acts not derogated from in this Regulation shall continue to apply. The Union type-approval authority shall take full responsibility for the obligations stemming from the Union type-approval. The Union type-approval authority shall also, from the time when the Union type-approval takes effect, exercise all the powers and fulfil all the obligations of the UK type-approval authority with respect to the following: (a) vehicles, systems, components or separate technical units produced on the basis of the UK type-approval already placed on the market, registered or entered into service in the Union; (b) vehicles, systems, components or separate technical units produced on the basis of the UK type-approval to be placed on the market, registered or entered into service in the Union in accordance with the third subparagraph. Vehicles, systems, components or separate technical units produced on the basis of a UK type-approval which has become invalid as a result of the granting of a Union type-approval may be placed on the market, registered and entered into service in the Union until the Union type-approval legislation referred to in Article 2(1) of this Regulation ceases to apply to and in the United Kingdom or, where the Union type-approval becomes invalid before that date pursuant to Article 17 of Directive 2007/46/EC, Article 32 of Regulation (EU) No 167/2013, Article 37 of Regulation (EU) No 168/2013 or Article 30 of Regulation (EU) 2016/1628, until the date on which the Union type-approval becomes invalid. For vehicles, manufacturers shall indicate the Union type-approval number in a supplement to the certificate of conformity before such vehicles are placed on the market, registered or entered into service in the Union. The Union type-approval authority shall not be liable for any acts or omissions of the UK type-approval authority. Article 6 Union type-approval authority responsible for vehicles, systems, components or separate technical units of types not approved under this Regulation 1. When applying for a Union type-approval under Article 4, a manufacturer shall also request the Union type-approval authority in question to take over the obligations of the UK type-approval authority with respect to the manufacturer's other vehicles, systems, components or separate technical units placed on the market, registered or entered into service in the Union on the basis of UK type-approvals that have either become invalid pursuant to Article 17 of Directive 2007/46/EC, Article 32 of Regulation (EU) No 167/2013, Article 37 of Regulation (EU) No 168/2013 or Article 30 of Regulation (EU) 2016/1628, or for which no Union type-approval is sought under this Regulation. Such request shall be made for all vehicles, systems, components and separate technical units based on UK type-approvals held by the manufacturer that were granted after 1 January 2008 unless the manufacturer presents proof to the Union type-approval authority that it has an agreement with another Union type-approval authority covering those vehicles, systems, components and separate technical units. 2. The Union type-approval authority may only grant a Union type-approval in accordance with Article 5 after it has accepted the request made pursuant to paragraph 1 of this Article and after the manufacturer has agreed to cover the costs that the Union type-approval authority incur as a result of exercising its powers and fulfilling its obligations in respect of the vehicles, systems, components and separate technical units concerned. 3. After accepting the request referred to in paragraph 1 of this Article and granting the Union type-approval in accordance with Article 5, the Union type-approval authority shall exercise all the powers and fulfil all the obligations of the UK type-approval authority with respect to all vehicles, systems, components or separate technical units produced on the basis of the UK type-approvals referred to in paragraph 1 of this Article regarding recalls, repair and maintenance information and in-service conformity checks. The Union type-approval authority shall not be liable for any acts or omissions of the UK type-approval authority. 4. The Union type-approval authority shall inform the type-approval authorities of the other Member States and the Commission of the types for which it has taken over the obligations of the UK type-approval authority in accordance with paragraph 1. Article 7 Specific provisions This Regulation shall not preclude the placing on the market, making available on the market, registration or entry into service of engines, or of vehicles and non-road mobile machinery in which such engines are installed, that conform to a type whose UK type-approval has become invalid while the Union type-approval legislation referred to in Article 2(1) of this Regulation still applies to and in the United Kingdom, in accordance with Article 10(7) of Directive 97/68/EC, Article 34(7) and (8) or Article 58(5) to (11) of Regulation (EU) 2016/1628 and acts adopted on the basis of Article 19(6), Article 20(8), Article 28(6) and Article 53(12) of Regulation (EU) No 167/2013. Article 8 Entry into force and application This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 8 January 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 440, 6.12.2018, p. 95. (2) Position of the European Parliament of 11 December 2018 (not yet published in the Official Journal) and decision of the Council of 20 December 2018. (3) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (OJ L 263, 9.10.2007, p. 1). (4) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1). (5) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52). (6) Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53).", "summary": "EU type-approval legislation with regard to the UKThe United Kingdom withdrew from the European Union and became a third country (non-EU country) as of 1 February 2020. withdrawal EU type-approval legislation with regard to the UK (1) withdrawal SUMMARY OF: Regulation (EU) 2019/26 \u2014 complementing EU type-approval legislation with regard to the withdrawal of the United Kingdom (1) from the EU WHAT IS THE AIM OF THIS REGULATION? It establishes new rules to ensure a smooth transition for the type-approval* of motor vehicles, as well as of systems, components and separate technical units intended for these vehicles, when the UK (1) leaves the EU. KEY POINTS Legal context Under EU law, the approval of a vehicle type in one EU country is valid EU-wide without the need for further tests and re-certification in other EU countries. After the UK's withdrawal from the EU (or at the end of the transition period, if the Withdrawal Agreement is ratified), the UK (1) type-approval authority will no longer be a national authority of an EU country. Therefore, without agreement on a new relationship between the two parties, it will no longer be possible for manufacturers to place vehicles on the market of the 27 remaining EU countries (EU-27) on the basis of type-approvals granted in the UK (1). EU-27 type-approval Manufacturers can apply to an EU-27 type-approval authority for types previously approved by the UK (1) authority. Manufacturers must: pay fees to the EU type-approval authority for carrying out its functions and duties;provide documentation and information to the EU authority if requested. Conditions for approval The type must comply with the rules for the placing on the market, registration or entry into service of new vehicles, systems, components or separate technical units applicable when the EU type-approval takes effect. Approval may be granted on the basis of the same test reports used for the granting of the UK (1) type-approval in accordance with the applicable rules, regardless of whether the technical service that issued the test report has been designated and notified by the EU country granting the EU type-approval. The EU authority can request the repetition of specific tests. These must be carried by a technical service designated and notified by that authority. EU type-approval takes effect on the day it is granted granting unless otherwise stated. The UK (1) type-approval becomes invalid on the day preceding that on which EU type-approval takes effect. In any event, UK (1) type-approval will become invalid at the latest on the day on which the EU type-approval legislation ceases to apply to and in the UK (1). EU type-approval authority From the time that the EU type-approval takes effect, the EU authority in question is responsible for vehicles, systems, components and separate technical units manufactured on the basis of the UK (1) type-approval and placed or to be placed on the market, registered or put into service in the EU. The manufacturer must also request that the EU authority in question takes over the obligations of the UK (1) type-approval authority concerning the manufacturer's other vehicles, systems, components or separate technical units placed on the market, registered or entered into service in the EU on the basis of UK (1) type-approvals that have either become invalid, or for which no EU type-approval is sought under this regulation. This request must be made for all vehicles, systems, components and separate technical units based on UK (1) type-approvals held by the manufacturer that were granted after 1 January 2008 unless the manufacturer can provide proof of an agreement with another EU type-approval authority covering those vehicles, systems, components and separate technical units. The EU authority is not responsible for any acts or omissions of the UK (1) authority. FROM WHEN DOES THE REGULATION APPLY? It has applied since 13 January 2019. BACKGROUND The EU has adopted specific type-approval and market surveillance rules for agricultural and forestry vehicles, as well as for 2 and 3 wheel vehicles and quadracycles. KEY TERMS Type-approval: the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies certain legal requirements. MAIN DOCUMENT Regulation (EU) 2019/26 of the European Parliament and of the Council of 8 January 2019 complementing Union type-approval legislation with regard to the withdrawal of the United Kingdom from the Union (OJ L 8I, 10.1.2019, pp. 1-7) RELATED DOCUMENTS Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, pp. 53-117) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, pp. 1-160) Successive amendments to Directive 2007/46/EC have been incorporated into the original document. This consolidated version is of documentary value only. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, pp. 1-51) See consolidated version. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, pp. 52-128) See consolidated version. last update 16.05.2019(1) The United Kingdom withdrew from the European Union and became a third country (non-EU country) as of 1 February 2020."}
{"article": "24.5.2016 EN Official Journal of the European Union L 135/53 REGULATION (EU) 2016/794 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 88 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Europol was set up by Council Decision 2009/371/JHA (2) as an entity of the Union funded from the general budget of the Union to support and strengthen action by competent authorities of the Member States and their mutual cooperation in preventing and combating organised crime, terrorism and other forms of serious crime affecting two or more Member States. Decision 2009/371/JHA replaced the Convention based on Article K.3 of the Treaty on European Union, on the establishment of a European Police Office (Europol Convention) (3). (2) Article 88 of the Treaty on the Functioning of the European Union (TFEU) provides for Europol to be governed by a regulation to be adopted in accordance with the ordinary legislative procedure. It also requires the establishment of procedures for the scrutiny of Europol's activities by the European Parliament, together with national parliaments, subject to point (c) of Article 12 of the Treaty on European Union (TEU) and Article 9 of Protocol No 1 on the role of National Parliaments in the European Union, annexed to the TEU and to the TFEU (\u2018Protocol No 1\u2019), in order to enhance the democratic legitimacy and accountability of Europol to the Union's citizens. Therefore, Decision 2009/371/JHA should be replaced by a regulation laying down, inter alia, rules on parliamentary scrutiny. (3) The \u2018Stockholm programme \u2014 An open and secure Europe serving and protecting citizens\u2019 (4) calls for Europol to evolve and become a hub for information exchange between the law enforcement authorities of the Member States, a service provider and a platform for law enforcement services. On the basis of an assessment of Europol's functioning, further enhancement of its operational effectiveness is needed to meet that objective. (4) Large-scale criminal and terrorist networks pose a significant threat to the internal security of the Union and to the safety and livelihood of its citizens. Available threat assessments show that criminal groups are becoming increasingly poly-criminal and cross-border in their activities. National law enforcement authorities therefore need to cooperate more closely with their counterparts in other Member States. In this context, it is necessary to equip Europol to better support Member States in Union-wide crime prevention, analyses and investigations. This was also confirmed in the evaluation of Decision 2009/371/JHA. (5) This Regulation aims to amend and expand the provisions of Decision 2009/371/JHA and of Council Decisions 2009/934/JHA (5), 2009/935/JHA (6), 2009/936/JHA (7) and 2009/968/JHA (8) implementing Decision 2009/371/JHA. Since the amendments to be made are of a substantial number and nature, those Decisions should, in the interests of clarity, be replaced in their entirety in relation to the Member States bound by this Regulation. Europol as established by this Regulation should replace and assume the functions of Europol as established by Decision 2009/371/JHA, which, as a consequence, should be repealed. (6) As serious crime often occurs across internal borders, Europol should support and strengthen Member States' actions and their cooperation in preventing and combating serious crime affecting two or more Member States. Given that terrorism is one of the most significant threats to the security of the Union, Europol should assist Member States in facing common challenges in this regard. As the Union law enforcement agency, Europol should also support and strengthen actions and cooperation in tackling forms of crime that affect the interests of the Union. Among the forms of crime with which Europol is competent to deal, organised crime will continue to fall within the scope of Europol's main objectives, as, given its scale, significance and consequences, it also calls for a common approach by the Member States. Europol should also offer support in preventing and combating related criminal offences which are committed in order to procure the means of perpetrating acts in respect of which Europol is competent or to facilitate or perpetrate such acts or to ensure the impunity of committing them. (7) Europol should provide strategic analyses and threat assessments to assist the Council and the Commission in laying down strategic and operational priorities of the Union for fighting crime and in the operational implementation of those priorities. Where the Commission so requests in accordance with Article 8 of Council Regulation (EU) No 1053/2013 (9), Europol should also carry out risk analyses, including in respect of organised crime, insofar as the risks concerned may undermine the application of the Schengen acquis by the Member States. Moreover, at the request of the Council or the Commission where appropriate, Europol should provide strategic analyses and threat assessments to contribute to the evaluation of states that are candidates for accession to the Union. (8) Attacks against information systems affecting Union bodies or two or more Member States are a growing menace in the Union, in particular in view of their speed and impact and the difficulty in identifying their sources. When considering requests by Europol to initiate an investigation into a serious attack of suspected criminal origin against information systems affecting Union bodies or two or more Member States, Member States should respond to Europol without delay, taking into account the fact that the rapidity of the response is a key factor in successfully tackling computer crime. (9) Given the importance of the inter-agency cooperation, Europol and Eurojust should ensure that necessary arrangements are established to optimise their operational cooperation, taking due account of their respective missions and mandates and of the interests of Member States. In particular, Europol and Eurojust should keep each other informed of any activity involving the financing of joint investigation teams. (10) When a joint investigation team is set up, the relevant agreement should determine the conditions relating to the participation of the Europol staff in the team. Europol should keep a record of its participation in such joint investigation teams targeting criminal activities falling within the scope of its objectives. (11) Europol should be able to request Member States to initiate, conduct or coordinate criminal investigations in specific cases where cross-border cooperation would add value. Europol should inform Eurojust of such requests. (12) Europol should be a hub for information exchange in the Union. Information collected, stored, processed, analysed and exchanged by Europol includes criminal intelligence which relates to information about crime or criminal activities falling within the scope of Europol's objectives, obtained with a view to establishing whether concrete criminal acts have been committed or may be committed in the future. (13) In order to ensure Europol's effectiveness as a hub for information exchange, clear obligations should be laid down requiring Member States to provide Europol with the data necessary for it to fulfil its objectives. While implementing such obligations, Member States should pay particular attention to providing data relevant to the fight against crimes considered to be strategic and operational priorities within relevant policy instruments of the Union, in particular the priorities set by the Council in the framework of the EU Policy Cycle for organised and serious international crime. Member States should also endeavour to provide Europol with a copy of bilateral and multilateral exchanges of information with other Member States on crime falling within Europol's objectives. When supplying Europol with the necessary information, Member States should also include information about any alleged cyber attacks affecting Union bodies located in their territory. At the same time, Europol should increase the level of its support to Member States, so as to enhance mutual cooperation and the sharing of information. Europol should submit an annual report to the European Parliament, to the Council, to the Commission and to national parliaments on the information provided by the individual Member States. (14) To ensure effective cooperation between Europol and Member States, a national unit should be set up in each Member State (the \u2018national unit\u2019). The national unit should be the liaison link between national competent authorities and Europol, thereby having a coordinating role in respect of Member States' cooperation with Europol, and thus helping to ensure that each Member State responds to Europol requests in a uniform way. To ensure a continuous and effective exchange of information between Europol and the national units, and to facilitate their cooperation, each national unit should designate at least one liaison officer to be attached to Europol. (15) Taking into account the decentralised structure of some Member States and the need to ensure rapid exchanges of information, Europol should be allowed to cooperate directly with competent authorities in Member States, subject to the conditions defined by Member States, while keeping the national units informed at the latter's request. (16) The establishment of joint investigation teams should be encouraged and Europol staff should be able to participate in them. To ensure that such participation is possible in every Member State, Council Regulation (Euratom, ECSC, EEC) No 549/69 (10) provides that Europol staff do not benefit from immunities while they are participating in joint investigation teams. (17) It is also necessary to improve the governance of Europol, by seeking efficiency gains and streamlining procedures. (18) The Commission and the Member States should be represented on the Management Board of Europol (the \u2018Management Board\u2019) to effectively supervise its work. The members and the alternate members of the Management Board should be appointed taking into account their relevant managerial, administrative and budgetary skills and knowledge of law enforcement cooperation. Alternate members should act as members in the absence of the member. (19) All parties represented on the Management Board should make efforts to limit the turnover of their representatives, with a view to ensuring the continuity of the Management Board's work. All parties should aim to achieve a balanced representation between men and women on the Management Board. (20) The Management Board should be able to invite non-voting observers whose opinion may be relevant for the discussion, including a representative designated by the Joint Parliamentary Scrutiny Group (JPSG). (21) The Management Board should be given the necessary powers, in particular to set the budget, verify its execution, and adopt the appropriate financial rules and planning documents, as well as adopt rules for the prevention and management of conflicts of interest in respect of its members, establish transparent working procedures for decision-making by the Executive Director of Europol, and adopt the annual activity report. It should exercise the powers of appointing authority vis-\u00e0-vis staff of the agency, including the Executive Director. (22) To ensure the efficient day-to-day functioning of Europol, the Executive Director should be its legal representative and manager, acting independently in the performance of his or her duties and ensuring that Europol carries out the tasks provided for by this Regulation. In particular, the Executive Director should be responsible for preparing budgetary and planning documents submitted for the decision of the Management Board and for implementing the multiannual programming and annual work programmes of Europol and other planning documents. (23) For the purposes of preventing and combating crime falling within the scope of its objectives, it is necessary for Europol to have the fullest and most up-to-date information possible. Therefore, Europol should be able to process data provided to it by Member States, Union bodies, third countries, international organisations and, under stringent conditions laid down by this Regulation, private parties, as well as data coming from publicly available sources, in order to develop an understanding of criminal phenomena and trends, to gather information about criminal networks, and to detect links between different criminal offences. (24) To improve Europol's effectiveness in providing accurate crime analyses to the competent authorities of the Member States, it should use new technologies to process data. Europol should be able to swiftly detect links between investigations and common modi operandi across different criminal groups, to check cross-matches of data and to have a clear overview of trends, while guaranteeing a high level of protection of personal data for individuals. Therefore, Europol databases should be structured in such a way as to allow Europol to choose the most efficient IT structure. Europol should also be able to act as a service provider, in particular by providing a secure network for the exchange of data, such as the secure information exchange network application (SIENA), aimed at facilitating the exchange of information between Member States, Europol, other Union bodies, third countries and international organisations. In order to ensure a high level of data protection, the purpose of processing operations and access rights as well as specific additional safeguards should be laid down. In particular, the principles of necessity and proportionality should be observed with regard to the processing of personal data. (25) Europol should ensure that all personal data processed for operational analyses are allocated a specific purpose. Nonetheless, in order for Europol to fulfil its mission, it should be allowed to process all personal data received to identify links between multiple crime areas and investigations, and should not be limited to identifying connections only within one crime area. (26) To respect the ownership of data and the protection of personal data, Member States, Union bodies, third countries and international organisations should be able to determine the purpose or purposes for which Europol may process the data they provide and to restrict access rights. Purpose limitation is a fundamental principle of personal data processing; in particular, it contributes to transparency, legal certainty and predictability and is particularly of high importance in the area of law enforcement cooperation, where data subjects are usually unaware when their personal data are being collected and processed and where the use of personal data may have a very significant impact on the lives and freedoms of individuals. (27) To ensure that data are accessed only by those needing access in order to perform their tasks, this Regulation should lay down detailed rules on different degrees of right of access to data processed by Europol. Such rules should be without prejudice to restrictions on access imposed by data providers, as the principle of ownership of data should be respected. In order to increase efficiency in the prevention and combating of crimes falling within the scope of Europol's objectives, Europol should notify Member States of information which concerns them. (28) To enhance operational cooperation between the agencies, and particularly to establish links between data already in the possession of the different agencies, Europol should enable Eurojust and the European Anti-Fraud Office (OLAF) to have access, on the basis of a hit/no hit system, to data available at Europol. Europol and Eurojust should be able to conclude a working arrangement ensuring, in a reciprocal manner within their respective mandates, access to, and the possibility of searching, all information that has been provided for the purpose of cross-checking in accordance with specific safeguards and data protection guarantees provided for in this Regulation. Any access to data available at Europol should, by technical means, be limited to information falling within the respective mandates of those Union bodies. (29) Europol should maintain cooperative relations with other Union bodies, authorities of third countries, international organisations and private parties, to the extent required for the accomplishment of its tasks. (30) To ensure operational effectiveness, Europol should be able to exchange all relevant information, with the exception of personal data, with other Union bodies, authorities of third countries and international organisations, to the extent necessary for the performance of its tasks. Since companies, firms, business associations, non-governmental organisations and other private parties hold expertise and information of direct relevance to the prevention and combating of serious crime and terrorism, Europol should also be able to exchange such information with private parties. To prevent and combat cybercrime, as related to network and information security incidents, Europol should, pursuant to the applicable legislative act of the Union laying down measures to ensure a high common level of network and information security across the Union, cooperate and exchange information, with the exception of personal data, with national authorities competent for the security of network and information systems. (31) Europol should be able to exchange relevant personal data with other Union bodies to the extent necessary for the accomplishment of its or their tasks. (32) Serious crime and terrorism often have links beyond the territory of the Union. Europol should therefore be able to exchange personal data with authorities of third countries and with international organisations such as the International Criminal Police Organisation \u2014 Interpol to the extent necessary for the accomplishment of its tasks. (33) All Member States are affiliated to Interpol. To fulfil its mission, Interpol receives, stores and circulates data to assist competent law enforcement authorities to prevent and combat international crime. Therefore, it is appropriate to strengthen cooperation between Europol and Interpol by promoting an efficient exchange of personal data whilst ensuring respect for fundamental rights and freedoms regarding the automatic processing of personal data. When personal data is transferred from Europol to Interpol, this Regulation, in particular the provisions on international transfers, should apply. (34) To guarantee purpose limitation, it is important to ensure that personal data can be transferred by Europol to Union bodies, third countries and international organisations only if necessary for preventing and combating crime that falls within Europol's objectives. To this end, it is necessary to ensure that, when personal data are transferred, the recipient gives an undertaking that the data will be used by the recipient or transferred onward to a competent authority of a third country solely for the purpose for which they were originally transferred. Further onward transfer of the data should take place in compliance with this Regulation. (35) Europol should be able to transfer personal data to an authority of a third country or an international organisation on the basis of a Commission decision finding that the country or international organisation in question ensures an adequate level of data protection (\u2018adequacy decision\u2019), or, in the absence of an adequacy decision, an international agreement concluded by the Union pursuant to Article 218 TFEU, or a cooperation agreement allowing for the exchange of personal data concluded between Europol and the third country prior to the entry into force of this Regulation. In light of Article 9 of Protocol No 36 on transitional provisions, annexed to the TEU and to the TFEU, the legal effects of such agreements are to be preserved until those agreements are repealed, annulled or amended in the implementation of the Treaties. Where appropriate and in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council (11), the Commission should be able to consult the European Data Protection Supervisor (EDPS) before and during the negotiation of an international agreement. Where the Management Board identifies an operational need for cooperation with a third country or an international organisation, it should be able to suggest to the Council that the latter draw the attention of the Commission to the need for an adequacy decision or for a recommendation for the opening of negotiations on an international agreement as referred to above. (36) Where a transfer of personal data cannot be based on an adequacy decision, an international agreement concluded by the Union or an existing cooperation agreement, the Management Board, in agreement with the EDPS, should be allowed to authorise a set of transfers, where specific conditions so require and provided that adequate safeguards are ensured. The Executive Director should be allowed to authorise the transfer of data in exceptional cases on a case-by-case basis, where such transfer is required, under specific strict conditions. (37) Europol should be able to process personal data originating from private parties and private persons only if those data are transferred to Europol by one of the following: a national unit in accordance with its national law; a contact point in a third country or an international organisation with which there is established cooperation through a cooperation agreement allowing for the exchange of personal data concluded in accordance with Article 23 of Decision 2009/371/JHA prior to the entry into force of this Regulation; an authority of a third country or an international organisation which is subject to an adequacy decision or with which the Union has concluded an international agreement pursuant to Article 218 TFEU. However, in cases where Europol receives personal data directly from private parties and the national unit, contact point or authority concerned cannot be identified, Europol should be able to process those personal data solely for the purpose of identifying those entities, and such data should be deleted unless those entities resubmit those personal data within four months after the transfer takes place. Europol should ensure by technical means that, during that period, such data would not be accessible for processing for any other purpose. (38) Taking into account the exceptional and specific threat posed to the internal security of the Union by terrorism and other forms of serious crime, especially when facilitated, promoted or committed using the internet, the activities that Europol should undertake on the basis of this Regulation, stemming from its implementation of the Council Conclusions of 12 March 2015 and the call by the European Council of 23 April 2015 in relation especially to those priority areas, in particular the corresponding practice of direct exchanges of personal data with private parties, should be evaluated by the Commission by 1 May 2019. (39) Any information which has clearly been obtained in obvious violation of human rights should not be processed. (40) Data protection rules at Europol should be strengthened and should draw on the principles underpinning Regulation (EC) No 45/2001 to ensure a high level of protection of individuals with regard to the processing of personal data. As Declaration No 21 on the protection of personal data in the fields of judicial cooperation in criminal matters and police cooperation, attached to the TEU and the TFEU, recognises the specificity of personal data processing in the law enforcement context, the data protection rules of Europol should be autonomous while at the same time consistent with other relevant data protection instruments applicable in the area of police cooperation in the Union. Those instruments include, in particular, Directive (EU) 2016/680 of the European Parliament and of the Council (12), as well as the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of the Council of Europe and its Recommendation No R(87) 15 (13). (41) Any processing of personal data by Europol should be lawful and fair in relation to the data subjects concerned. The principle of fair processing requires transparency of processing allowing data subjects concerned to exercise their rights under this Regulation. It should be possible nevertheless to refuse or restrict access to their personal data if, with due regard to the interests of the data subjects concerned, such refusal or restriction constitutes a necessary measure to enable Europol to fulfil its tasks properly, to protect security and public order or to prevent crime, to guarantee that a national investigation will not be jeopardised or to protect the rights and freedoms of third parties. To enhance transparency, Europol should make publicly available a document setting out in an intelligible form the applicable provisions regarding the processing of personal data and the means available to data subjects to exercise their rights. Europol should also publish on its website a list of adequacy decisions, agreements and administrative arrangements relating to the transfer of personal data to third countries and international organisations. Moreover, in order to increase Europol's transparency vis-\u00e0-vis Union citizens and its accountability, Europol should publish on its website a list of its Management Board members and, where appropriate, the summaries of the outcome of the meetings of the Management Board, while respecting data protection requirements. (42) As far as possible, personal data should be distinguished according to their degree of accuracy and reliability. Facts should be distinguished from personal assessments, in order to ensure both the protection of individuals and the quality and reliability of the information processed by Europol. In the case of information obtained from publicly available sources, particularly sources on the internet, Europol should as far as possible assess the accuracy of such information and the reliability of its source with particular diligence in order to address the risks associated with the internet as regards the protection of personal data and privacy. (43) Personal data relating to different categories of data subjects are processed in the area of law enforcement cooperation. Europol should make distinctions between personal data in respect of different categories of data subjects as clear as possible. Personal data concerning persons such as victims, witnesses and persons possessing relevant information, as well as personal data concerning minors, should in particular be protected. Europol should only process sensitive data if those data supplement other personal data already processed by Europol. (44) In the light of the fundamental right to the protection of personal data, Europol should not store personal data for longer than is necessary for the performance of its tasks. The need for continued storage of such data should be reviewed no later than three years after the start of its initial processing. (45) To guarantee the security of personal data, Europol and Member States should implement necessary technical and organisational measures. (46) Any data subject should have a right of access to personal data concerning him or her, a right to rectification if those data are inaccurate, and a right to erasure or restriction if those data are no longer required. The costs related to exercising the right of access to personal data should not represent a barrier to effectively exercising that right. The rights of the data subject and the exercise thereof should not affect the obligations incumbent upon Europol and should be subject to the restrictions laid down in this Regulation. (47) The protection of the rights and freedoms of data subjects requires a clear attribution of the responsibilities under this Regulation. In particular, Member States should be responsible for the accuracy of data, for keeping up to date the data they have transferred to Europol and for the legality of such data transfers. Europol should be responsible for the accuracy of data and for keeping up to date the data provided by other data suppliers or resulting from Europol's own analyses. Europol should ensure that data are processed fairly and lawfully, and are collected and processed for a specific purpose. Europol should also ensure that the data are adequate, relevant, not excessive in relation to the purpose for which they are processed, stored no longer than is necessary for that purpose, and processed in a manner that ensures appropriate security of personal data and confidentiality of data processing. (48) Europol should keep records of collection, alteration, access, disclosure, combination or erasure of personal data for the purposes of verifying the lawfulness of the data processing, self-monitoring and ensuring proper data integrity and security. Europol should be obliged to co-operate with the EDPS and to make logs or documentation available upon request, so that they can be used for monitoring processing operations. (49) Europol should designate a Data Protection Officer to assist it in monitoring compliance with this Regulation. The Data Protection Officer should be in a position to perform his or her duties and tasks independently and effectively, and should be provided with the necessary resources to do so. (50) Independent, transparent, accountable and effective structures for supervision are essential for the protection of individuals with regard to the processing of personal data as required by Article 8(3) of the Charter of Fundamental Rights of the European Union. National authorities competent for the supervision of the processing of personal data should monitor the lawfulness of personal data provided by Member States to Europol. The EDPS should monitor the lawfulness of data processing carried out by Europol, exercising his or her functions with complete independence. In this regard, the prior consultation mechanism is an important safeguard for new types of processing operations. This should not apply to specific individual operational activities, such as operational analysis projects, but to the use of new IT systems for the processing of personal data and any substantial changes thereto. (51) It is important to ensure strengthened and effective supervision of Europol and to guarantee that the EDPS can make use of appropriate law enforcement data protection expertise when he or she assumes responsibility for data protection supervision of Europol. The EDPS and national supervisory authorities should closely cooperate with each other on specific issues requiring national involvement and should ensure the consistent application of this Regulation throughout the Union. (52) In order to facilitate the cooperation between the EDPS and the national supervisory authorities, but without prejudice to the independence of the EDPS and his or her responsibility for data protection supervision of Europol, they should regularly meet within the Cooperation Board, which, as an advisory body, should deliver opinions, guidelines, recommendations and best practices on various issues requiring national involvement. (53) As Europol also processes non-operational personal data, unrelated to criminal investigations, such as personal data concerning staff of Europol, service providers or visitors, the processing of such data should be subject to Regulation (EC) No 45/2001. (54) The EDPS should hear and investigate complaints lodged by data subjects. The investigation following a complaint should be carried out, subject to judicial review, to the extent that is appropriate in the specific case. The national supervisory authority should inform the data subject of the progress and the outcome of the complaint within a reasonable period. (55) Any individual should have the right to a judicial remedy against a decision of the EDPS concerning him or her. (56) Europol should be subject to the general rules on contractual and non-contractual liability applicable to Union institutions, agencies and bodies, save as regards the rules on liability for unlawful data processing. (57) It may be unclear for the individual concerned whether damage suffered as a result of unlawful data processing is a consequence of action by Europol or by a Member State. Europol and the Member State in which the event that gave rise to the damage occurred should therefore be jointly and severally liable. (58) While respecting the role of the European Parliament together with national parliaments in the scrutiny of Europol's activities, it is necessary that Europol be a fully accountable and transparent internal organisation. To that end, in light of Article 88 TFEU, procedures should be established for the scrutiny of Europol's activities by the European Parliament together with national parliaments. Such procedures should be subject to point (c) of Article 12 TEU and to Article 9 of Protocol No 1, providing that the European Parliament and national parliaments are together to determine the organisation and promotion of effective and regular interparliamentary cooperation within the Union. The procedures to be established for the scrutiny of Europol's activities should take due account of the need to ensure that the European Parliament and the national parliaments stand on an equal footing, as well as the need to safeguard the confidentiality of operational information. However, the way in which national parliaments scrutinise their governments in relation to the activities of the Union is a matter for the particular constitutional organisation and practice of each Member State. (59) The Staff Regulations of Officials of the European Union (the \u2018Staff Regulations\u2019) and the Conditions of Employment of Other Servants of the European Union (the \u2018Conditions of Employment of Other Servants\u2019) laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (14) should apply to Europol staff. Europol should be able to employ staff from the competent authorities of the Member States as temporary agents whose period of service should be limited in order to maintain the principle of rotation, as the subsequent reintegration of such staff members into the service of their competent authority facilitates close cooperation between Europol and the competent authorities of the Member States. Member States should take any measure necessary to ensure that staff engaged at Europol as temporary agents may, at the end of their term of service at Europol, return to the national civil service to which they belong. (60) Given the nature of the duties of Europol and the role of the Executive Director, the competent committee of the European Parliament should be able to invite the Executive Director to appear before it prior to his or her appointment, as well as prior to any extension of his or her term of office. The Executive Director should also present the annual report to the European Parliament and to the Council. Furthermore, the European Parliament and the Council should be able to invite the Executive Director to report on the performance of his or her duties. (61) To guarantee the full autonomy and independence of Europol, it should be granted an autonomous budget, with revenue coming essentially from a contribution from the general budget of the Union. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors. (62) Commission Delegated Regulation (EU) No 1271/2013 (15) should apply to Europol. (63) Given their specific legal and administrative powers and their technical competences in conducting cross-border information-exchange activities, operations and investigations, including in joint investigation teams, and in providing facilities for training, the competent authorities of the Member States should be able to receive grants from Europol without a call for proposals in accordance with point (d) of Article 190(1) of Commission Delegated Regulation (EU) No 1268/2012 (16). (64) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (17) should apply to Europol. (65) Europol processes data that require particular protection as they include sensitive non-classified and EU classified information. Europol should therefore draw up rules on the confidentiality and processing of such information. The rules on the protection of EU classified information should be consistent with Council Decision 2013/488/EU (18). (66) It is appropriate to evaluate the application of this Regulation regularly. (67) The necessary provisions regarding accommodation for Europol in The Hague, where it has its headquarters, and the specific rules applicable to all Europol's staff and members of their families should be laid down in a headquarters agreement. Furthermore, the host Member State should provide the necessary conditions for the smooth operation of Europol, including multilingual, European-oriented schooling and appropriate transport connections, so as to attract high-quality human resources from as wide a geographical area as possible. (68) Europol as established by this Regulation replaces and succeeds Europol as established by Decision 2009/371/JHA. It should therefore be the legal successor of all its contracts, including employment contracts, liabilities and properties acquired. International agreements concluded by Europol as established by Decision 2009/371/JHA and agreements concluded by Europol as established by the Europol Convention before 1 January 2010 should remain in force. (69) To enable Europol to continue to fulfil the tasks of Europol as established by Decision 2009/371/JHA to the best of its abilities, transitional measures should be laid down, in particular with regard to the Management Board, the Executive Director and staff employed under a contract of indefinite duration as a local staff member concluded by Europol as established by the Europol Convention, who should be offered the possibility of employment as a member of the temporary or contract staff under the Conditions of Employment of Other Servants. (70) The Council Act of 3 December 1998 (19) on Europol staff regulations has been repealed by Article 63 of Decision 2009/371/JHA. However, it should continue to apply to staff employed by Europol before the entry into force of Decision 2009/371/JHA. Therefore, transitional provisions should provide that contracts concluded in accordance with those staff regulations are to remain governed by them. (71) Since the objective of this Regulation, namely the establishment of an entity responsible for law enforcement cooperation at Union level, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (72) In accordance with Article 3 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, Ireland has notified its wish to take part in the adoption and application of this Regulation. (73) In accordance with Articles 1 and 2 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and the TFEU, and without prejudice to Article 4 of that Protocol, the United Kingdom is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (74) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (75) The EDPS has been consulted and issued an opinion on 31 May 2013. (76) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, in particular the right to the protection of personal data and the right to privacy as protected by Articles 8 and 7 of the Charter, as well as by Article 16 TFEU, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS, OBJECTIVES AND TASKS OF EUROPOL Article 1 Establishment of the European Union Agency for Law Enforcement Cooperation 1. A European Union Agency for Law Enforcement Cooperation (Europol) is hereby established with a view to supporting cooperation among law enforcement authorities in the Union. 2. Europol as established by this Regulation shall replace and succeed Europol as established by Decision 2009/371/JHA. Article 2 Definitions For the purposes of this Regulation: (a) \u2018the competent authorities of the Member States\u2019 means all police authorities and other law enforcement services existing in the Member States which are responsible under national law for preventing and combating criminal offences. The competent authorities shall also comprise other public authorities existing in the Member States which are responsible under national law for preventing and combating criminal offences in respect of which Europol is competent; (b) \u2018strategic analysis\u2019 means all methods and techniques by which information is collected, stored, processed and assessed with the aim of supporting and developing a criminal policy that contributes to the efficient and effective prevention of, and the fight against, crime; (c) \u2018operational analysis\u2019 means all methods and techniques by which information is collected, stored, processed and assessed with the aim of supporting criminal investigations; (d) \u2018Union bodies\u2019 means institutions, bodies, missions, offices and agencies set up by, or on the basis of, the TEU and the TFEU; (e) \u2018international organisation\u2019 means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries; (f) \u2018private parties\u2019 means entities and bodies established under the law of a Member State or third country, in particular companies and firms, business associations, non-profit organisations and other legal persons that are not covered by point (e); (g) \u2018private persons\u2019 means all natural persons; (h) \u2018personal data\u2019 means any information relating to a data subject; (i) \u2018data subject\u2019 means an identified or identifiable natural person, an identifiable person being a person who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data or an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that person; (j) \u2018genetic data\u2019 means all personal data relating to the genetic characteristics of an individual that have been inherited or acquired, which give unique information about the physiology or the health of that individual, resulting in particular from an analysis of a biological sample from the individual in question; (k) \u2018processing\u2019 means any operation or set of operations which is performed upon personal data or sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction; (l) \u2018recipient\u2019 means a natural or legal person, public authority, agency or any other body to which data are disclosed, whether a third party or not; (m) \u2018transfer of personal data\u2019 means the communication of personal data, actively made available, between a limited number of identified parties, with the knowledge or intention of the sender to give the recipient access to the personal data; (n) \u2018personal data breach\u2019 means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed; (o) \u2018the data subject's consent\u2019 means any freely given, specific, informed and unambiguous indication of his or her wishes by which the data subject, either by a statement or by a clear affirmative action, signifies agreement to personal data relating to him or her being processed; (p) \u2018administrative personal data\u2019 means all personal data processed by Europol apart from those that are processed to meet the objectives laid down in Article 3. Article 3 Objectives 1. Europol shall support and strengthen action by the competent authorities of the Member States and their mutual cooperation in preventing and combating serious crime affecting two or more Member States, terrorism and forms of crime which affect a common interest covered by a Union policy, as listed in Annex I. 2. In addition to paragraph 1, Europol's objectives shall also cover related criminal offences. The following shall be considered to be related criminal offences: (a) criminal offences committed in order to procure the means of perpetrating acts in respect of which Europol is competent; (b) criminal offences committed in order to facilitate or perpetrate acts in respect of which Europol is competent; (c) criminal offences committed in order to ensure the impunity of those committing acts in respect of which Europol is competent. Article 4 Tasks 1. Europol shall perform the following tasks in order to achieve the objectives set out in Article 3: (a) collect, store, process, analyse and exchange information, including criminal intelligence; (b) notify the Member States, via the national units established or designated pursuant to Article 7(2), without delay of any information and connections between criminal offences concerning them; (c) coordinate, organise and implement investigative and operational actions to support and strengthen actions by the competent authorities of the Member States, that are carried out: (i) jointly with the competent authorities of the Member States; or (ii) in the context of joint investigation teams in accordance with Article 5 and, where appropriate, in liaison with Eurojust; (d) participate in joint investigation teams, as well as propose that they be set up in accordance with Article 5; (e) provide information and analytical support to Member States in connection with major international events; (f) prepare threat assessments, strategic and operational analyses and general situation reports; (g) develop, share and promote specialist knowledge of crime prevention methods, investigative procedures and technical and forensic methods, and provide advice to Member States; (h) support Member States' cross-border information exchange activities, operations and investigations, as well as joint investigation teams, including by providing operational, technical and financial support; (i) provide specialised training and assist Member States in organising training, including with the provision of financial support, within the scope of its objectives and in accordance with the staffing and budgetary resources at its disposal in coordination with the European Union Agency for Law Enforcement Training (CEPOL); (j) cooperate with the Union bodies established on the basis of Title V of the TFEU and with OLAF, in particular through exchanges of information and by providing them with analytical support in the areas that fall within their competence; (k) provide information and support to EU crisis management structures and missions established on the basis of the TEU, within the scope of Europol's objectives as set out in Article 3; (l) develop Union centres of specialised expertise for combating certain types of crime falling within the scope of Europol's objectives, in particular the European Cybercrime Centre; (m) support Member States' actions in preventing and combating forms of crime listed in Annex I which are facilitated, promoted or committed using the internet, including, in cooperation with Member States, the making of referrals of internet content, by which such forms of crime are facilitated, promoted or committed, to the online service providers concerned for their voluntary consideration of the compatibility of the referred internet content with their own terms and conditions. 2. Europol shall provide strategic analyses and threat assessments to assist the Council and the Commission in laying down strategic and operational priorities of the Union for fighting crime. Europol shall also assist in the operational implementation of those priorities. 3. Europol shall provide strategic analyses and threat assessments to assist the efficient and effective use of the resources available at national and Union level for operational activities and the support of those activities. 4. Europol shall act as the Central Office for combating euro counterfeiting in accordance with Council Decision 2005/511/JHA (20). Europol shall also encourage the coordination of measures carried out to fight euro counterfeiting by the competent authorities of the Member States or in the context of joint investigation teams, where appropriate in liaison with Union bodies and the authorities of third countries. 5. Europol shall not apply coercive measures in carrying out its tasks. CHAPTER II COOPERATION BETWEEN MEMBER STATES AND EUROPOL Article 5 Participation in joint investigation teams 1. Europol staff may participate in the activities of joint investigation teams dealing with crime falling within Europol's objectives. The agreement setting up a joint investigation team shall determine the conditions relating to the participation of the Europol staff in the team, and shall include information on the rules on liability. 2. Europol staff may, within the limits of the laws of the Member States in which a joint investigation team is operating, assist in all activities and exchanges of information with all members of the joint investigation team. 3. Europol staff participating in a joint investigation team may, in accordance with this Regulation, provide all members of the team with necessary information processed by Europol for the purposes set out in Article 18(2). Europol shall at the same time inform the national units of the Member States represented in the team, as well as those of the Member States which provided the information. 4. Information obtained by Europol staff while part of the joint investigation team may, with the consent and under the responsibility of the Member State which provided the information, be processed by Europol for the purposes set out in Article 18(2), under the conditions laid down in this Regulation. 5. Where Europol has reason to believe that setting up a joint investigation team would add value to an investigation, it may propose this to the Member States concerned and take measures to assist them in setting up the joint investigation team. Article 6 Request by Europol for the initiation of a criminal investigation 1. In specific cases where Europol considers that a criminal investigation should be initiated into a crime falling within the scope of its objectives, it shall request the competent authorities of the Member States concerned via the national units to initiate, conduct or coordinate such a criminal investigation. 2. The national units shall inform Europol without delay of the decision of the competent authorities of the Member States concerning any request made pursuant to paragraph 1. 3. If the competent authorities of a Member State decide not to accede to a request made by Europol pursuant to paragraph 1, they shall inform Europol of the reasons for their decision without undue delay, preferably within one month of receipt of the request. However, the reasons may be withheld if providing them would: (a) be contrary to the essential interests of the security of the Member State concerned; or (b) jeopardise the success of an ongoing investigation or the safety of an individual. 4. Europol shall immediately inform Eurojust of any request made pursuant to paragraph 1 and of any decision of a competent authority of a Member State pursuant to paragraph 2. Article 7 Europol national units 1. The Member States and Europol shall cooperate with each other in the fulfilment of their respective tasks set out in this Regulation. 2. Each Member State shall establish or designate a national unit, which shall be the liaison body between Europol and the competent authorities of that Member State. Each Member State shall appoint an official as the head of its national unit. 3. Each Member State shall ensure that its national unit is competent under national law to fulfil the tasks assigned to national units in this Regulation, and in particular that it has access to national law enforcement data and other relevant data necessary for cooperation with Europol. 4. Each Member State shall determine the organisation and the staff of its national unit in accordance with its national law. 5. In accordance with paragraph 2, the national unit shall be the liaison body between Europol and the competent authorities of the Member States. However, subject to conditions determined by the Member States, including prior involvement of the national unit, the Member States may allow direct contacts between their competent authorities and Europol. The national unit shall at the same time receive from Europol any information exchanged in the course of direct contacts between Europol and the competent authorities, unless the national unit indicates that it does not need to receive such information. 6. Each Member State shall, via its national unit or, subject to paragraph 5, a competent authority, in particular: (a) supply Europol with the information necessary for it to fulfil its objectives, including information relating to forms of crime the prevention or combating of which is considered a priority by the Union; (b) ensure effective communication and cooperation of all relevant competent authorities with Europol; (c) raise awareness of Europol's activities; (d) in accordance with point (a) of Article 38(5), ensure compliance with national law when supplying information to Europol. 7. Without prejudice to the discharge by Member States of their responsibilities with regard to the maintenance of law and order and the safeguarding of internal security, Member States shall not in any particular case be obliged to supply information in accordance with point (a) of paragraph 6 that would: (a) be contrary to the essential interests of the security of the Member State concerned; (b) jeopardise the success of an ongoing investigation or the safety of an individual; or (c) disclose information relating to organisations or specific intelligence activities in the field of national security. However, Member States shall supply information as soon as it ceases to fall within the scope of points (a), (b) or (c) of the first subparagraph. 8. Member States shall ensure that their financial intelligence units established pursuant to Directive 2005/60/EC of the European Parliament and of the Council (21) are allowed to cooperate with Europol via their national unit regarding analyses, within the limits of their mandate and competence. 9. The heads of the national units shall meet on a regular basis, in particular to discuss and resolve problems that occur in the context of their operational cooperation with Europol. 10. The costs incurred by national units in communications with Europol shall be borne by the Member States and, with the exception of the costs of connection, shall not be charged to Europol. 11. Europol shall draw up an annual report on the information provided by each Member State pursuant to point (a) of paragraph 6 on the basis of the quantitative and qualitative evaluation criteria defined by the Management Board. The annual report shall be sent to the European Parliament, the Council, the Commission and national parliaments. Article 8 Liaison officers 1. Each national unit shall designate at least one liaison officer to be attached to Europol. Except as otherwise laid down in this Regulation, the liaison officers shall be subject to the national law of the designating Member State. 2. Liaison officers shall constitute the national liaison bureaux at Europol and shall be instructed by their national units to represent the interests of the latter within Europol in accordance with the national law of the designating Member State and the provisions applicable to the administration of Europol. 3. Liaison officers shall assist in the exchange of information between Europol and their Member States. 4. Liaison officers shall, in accordance with their national law, assist in the exchange of information between their Member States and the liaison officers of other Member States, third countries and international organisations. Europol's infrastructure may be used, in accordance with national law, for such bilateral exchanges also to cover crimes falling outside the scope of the objectives of Europol. All such exchanges of information shall be in accordance with applicable Union and national law. 5. The Management Board shall determine the rights and obligations of liaison officers in relation to Europol. Liaison officers shall enjoy the privileges and immunities necessary for the performance of their tasks in accordance with Article 63(2). 6. Europol shall ensure that liaison officers are fully informed of and associated with all of its activities, in so far as necessary for the performance of their tasks. 7. Europol shall cover the costs of providing Member States with the necessary premises within the Europol building and adequate support for liaison officers to perform their duties. All other costs that arise in connection with the designation of liaison officers shall be borne by the designating Member State, including the costs of equipment for liaison officers, unless the European Parliament and the Council decide otherwise on the recommendation of the Management Board. CHAPTER III ORGANISATION OF EUROPOL Article 9 Administrative and management structure of Europol The administrative and management structure of Europol shall comprise: (a) a Management Board; (b) an Executive Director; (c) where appropriate, other advisory bodies established by the Management Board in accordance with point (s) of Article 11(1). SECTION 1 Management Board Article 10 Composition of the Management Board 1. The Management Board shall be composed of one representative from each Member State and one representative of the Commission. Each representative shall have a voting right. 2. The members of the Management Board shall be appointed taking into account their knowledge of law enforcement cooperation. 3. Each member of the Management Board shall have an alternate member who shall be appointed taking into account the criterion set out in paragraph 2. The alternate member shall represent the member in his or her absence. The principle of a balanced gender representation on the Management Board shall also be taken into account. 4. Without prejudice to the right of the Member States and of the Commission to terminate the mandate of their respective member and alternate member, the membership of the Management Board shall be for a period of four years. That term shall be extendable. Article 11 Functions of the Management Board 1. The Management Board shall: (a) adopt each year, by a majority of two-thirds of its members and in accordance with Article 12, a document containing Europol's multiannual programming and its annual work programme for the following year; (b) adopt, by a majority of two-thirds of its members, the annual budget of Europol and exercise other functions in respect of Europol's budget pursuant to Chapter X; (c) adopt a consolidated annual activity report on Europol's activities and, by 1 July of the following year, send it to the European Parliament, the Council, the Commission, the Court of Auditors and the national parliaments. The consolidated annual activity report shall be made public; (d) adopt the financial rules applicable to Europol in accordance with Article 61; (e) adopt an internal anti-fraud strategy, proportionate to fraud risks, taking into account the costs and benefits of the measures to be implemented; (f) adopt rules for the prevention and management of conflicts of interest in respect of its members, including in relation to their declaration of interests; (g) in accordance with paragraph 2, exercise, with respect to the staff of Europol, the powers conferred by the Staff Regulations on the appointing authority and by the Conditions of Employment of Other Servants on the authority empowered to conclude a contract of employment of other servants (\u2018the appointing authority powers\u2019); (h) adopt appropriate implementing rules giving effect to the Staff Regulations and the Conditions of Employment of Other Servants in accordance with Article 110 of the Staff Regulations; (i) adopt internal rules regarding the procedure for the selection of the Executive Director, including rules on the composition of the selection committee which ensure its independence and impartiality; (j) propose to the Council a shortlist of candidates for the posts of Executive Director and Deputy Executive Directors and, where relevant, propose to the Council that their terms of office be extended or that they be removed from office in accordance with Articles 54 and 55; (k) establish performance indicators and oversee the Executive Director's performance, including the implementation of Management Board decisions; (l) appoint a Data Protection Officer, who shall be functionally independent in the performance of his or her duties; (m) appoint an accounting officer, who shall be subject to the Staff Regulations and the Conditions of Employment of Other Servants and functionally independent in the performance of his or her duties; (n) establish, where appropriate, an internal audit capability; (o) ensure adequate follow-up to findings and recommendations stemming from the internal or external audit reports and evaluations, as well as from investigations of OLAF and the EDPS; (p) define the evaluation criteria for the annual report in accordance with Article 7(11); (q) adopt guidelines further specifying the procedures for the processing of information by Europol in accordance with Article 18, after consulting the EDPS; (r) decide upon the conclusion of working and administrative arrangements in accordance with Article 23(4) and Article 25(1), respectively; (s) decide, taking into consideration both business and financial requirements, upon the establishment of Europol's internal structures, including Union centres of specialised expertise as referred to in point (l) of Article 4(1), upon a proposal of the Executive Director; (t) adopt its rules of procedure, including provisions concerning the tasks and the functioning of its secretariat; (u) adopt, where appropriate, other internal rules. 2. If the Management Board considers it necessary for the performance of Europol's tasks, it may suggest to the Council that it draw the attention of the Commission to the need for an adequacy decision as referred to in point (a) of Article 25(1) or for a recommendation for a decision authorising the opening of negotiations with a view to the conclusion of an international agreement as referred to in point (b) of Article 25(1). 3. The Management Board shall, in accordance with Article 110 of the Staff Regulations, adopt a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment of Other Servants delegating the relevant appointing authority powers to the Executive Director and establishing the conditions under which such delegation of powers may be suspended. The Executive Director shall be authorised to subdelegate those powers. Where exceptional circumstances so require, the Management Board may, by way of a decision, temporarily suspend the delegation of the appointing authority powers to the Executive Director and any subdelegation of such powers and exercise them itself or delegate those powers to one of its members or to a staff member other than the Executive Director. Article 12 Multiannual programming and annual work programmes 1. The Management Board shall, by 30 November each year, adopt a document containing Europol's multiannual programming and annual work programme, based on a draft put forward by the Executive Director, taking into account the opinion of the Commission and, as regards the multiannual programming, after having consulted the JPSG. The Management Board shall forward that document to the Council, the Commission and the JPSG. 2. The multiannual programming shall set out the overall strategic programming, including the objectives, expected results and performance indicators. It shall also set out the resource planning, including the multiannual budget and staff. It shall include the strategy for relations with third countries and international organisations. The multiannual programming shall be implemented by means of annual work programmes and shall, where appropriate, be updated following the outcome of external and internal evaluations. The conclusion of those evaluations shall also be reflected, where appropriate, in the annual work programme for the following year. 3. The annual work programme shall comprise detailed objectives, expected results and performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual work programme shall be consistent with the multiannual programming. It shall clearly indicate tasks that have been added, changed or deleted compared to the previous financial year. 4. Where, after adoption of an annual work programme, a new task is assigned to Europol, the Management Board shall amend the annual work programme. 5. Any substantial amendment to the annual work programme shall be adopted by the same procedure as that applicable to the adoption of the initial annual work programme. The Management Board may delegate to the Executive Director the power to make non-substantial amendments to the annual work programme. Article 13 Chairperson and Deputy Chairperson of the Management Board 1. The Management Board shall elect a Chairperson and a Deputy Chairperson from within the group of three Member States that have jointly prepared the Council's 18-month programme. They shall serve for the 18-month period corresponding to that Council programme. If, however, the Chairperson's or the Deputy Chairperson's membership of the Management Board ends at any time during their term of office as Chairperson or Deputy Chairperson, their term of office shall automatically expire at the same time. 2. The Chairperson and the Deputy Chairperson shall be elected by a majority of two-thirds of the members of the Management Board. 3. Where the Chairperson is unable to carry out his or her duties, he or she shall automatically be replaced by the Deputy Chairperson. Article 14 Meetings of the Management Board 1. The Chairperson shall convene the meetings of the Management Board. 2. The Executive Director shall take part in the deliberations of the Management Board. 3. The Management Board shall hold at least two ordinary meetings a year. In addition, it shall meet on the initiative of its Chairperson, or at the request of the Commission or of at least one-third of its members. 4. The Management Board may invite any person whose opinion may be relevant for the discussion, including, where appropriate, a representative of the JPSG, to attend its meeting as a non-voting observer. 5. The members and the alternate members of the Management Board may, subject to its rules of procedure, be assisted at the meetings by advisers or experts. 6. Europol shall provide the secretariat for the Management Board. Article 15 Voting rules of the Management Board 1. Without prejudice to points (a) and (b) of Article 11(1), Article 13(2), Article 50(2), Article 54(8) and Article 64, the Management Board shall take decisions by a majority of its members. 2. Each member shall have one vote. In the absence of a voting member, his or her alternate shall be entitled to exercise his or her right to vote. 3. The Executive Director shall not take part in the vote. 4. The Management Board's rules of procedure shall establish more detailed voting arrangements, in particular the circumstances in which a member may act on behalf of another member, and any quorum requirements, where necessary. SECTION 2 Executive Director Article 16 Responsibilities of the Executive Director 1. The Executive Director shall manage Europol. He or she shall be accountable to the Management Board. 2. Without prejudice to the powers of the Commission or the Management Board, the Executive Director shall be independent in the performance of his or her duties and shall neither seek nor take instructions from any government or any other body. 3. The Council may invite the Executive Director to report on the performance of his or her duties. 4. The Executive Director shall be the legal representative of Europol. 5. The Executive Director shall be responsible for the implementation of the tasks assigned to Europol by this Regulation, in particular: (a) the day-to-day administration of Europol; (b) making proposals to the Management Board as regards the establishment of Europol's internal structures; (c) implementing decisions adopted by the Management Board; (d) preparing the draft multiannual programming and annual work programmes and submitting them to the Management Board, after having consulted the Commission; (e) implementing the multiannual programming and the annual work programmes and reporting to the Management Board on their implementation; (f) preparing appropriate draft implementing rules to give effect to the Staff Regulations and the Conditions of Employment of Other Servants in accordance with Article 110 of the Staff Regulations; (g) preparing the draft consolidated annual report on Europol's activities and presenting it to the Management Board for adoption; (h) preparing an action plan following up conclusions of internal or external audit reports and evaluations, as well as investigation reports and recommendations from investigations by OLAF and the EDPS, and reporting on progress twice a year to the Commission and regularly to the Management Board; (i) protecting the financial interests of the Union by applying measures to prevent fraud, corruption and any other illegal activity and, without prejudice to the investigative competence of OLAF, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties; (j) preparing a draft internal anti-fraud strategy for Europol and presenting it to the Management Board for adoption; (k) preparing draft internal rules for the prevention and management of conflicts of interest in respect of the members of the Management Board and presenting those draft rules to the Management Board for adoption; (l) preparing draft financial rules applicable to Europol; (m) preparing Europol's draft statement of estimates of revenue and expenditure and implementing its budget; (n) supporting the Chairperson of the Management Board in preparing Management Board meetings; (o) informing the Management Board on a regular basis regarding the implementation of Union strategic and operational priorities for fighting crime; (p) performing other tasks pursuant to this Regulation. CHAPTER IV PROCESSING OF INFORMATION Article 17 Sources of information 1. Europol shall only process information that has been provided to it: (a) by Member States in accordance with their national law and Article 7; (b) by Union bodies, third countries and international organisations in accordance with Chapter V; (c) by private parties and private persons in accordance with Chapter V. 2. Europol may directly retrieve and process information, including personal data, from publicly available sources, including the internet and public data. 3. In so far as Europol is entitled under Union, international or national legal instruments to gain computerised access to data from Union, international or national information systems, it may retrieve and process information, including personal data, by such means if that is necessary for the performance of its tasks. The applicable provisions of such Union, international or national legal instruments shall govern access to, and the use of, that information by Europol, in so far as they provide for stricter rules on access and use than those laid down by this Regulation. Access to such information systems shall be granted only to duly authorised staff of Europol and only in so far as this is necessary and proportionate for the performance of their tasks. Article 18 Purposes of information processing activities 1. In so far as is necessary for the achievement of its objectives as laid down in Article 3, Europol may process information, including personal data. 2. Personal data may be processed only for the purposes of: (a) cross-checking aimed at identifying connections or other relevant links between information related to: (i) persons who are suspected of having committed or taken part in a criminal offence in respect of which Europol is competent, or who have been convicted of such an offence; (ii) persons regarding whom there are factual indications or reasonable grounds to believe that they will commit criminal offences in respect of which Europol is competent; (b) analyses of a strategic or thematic nature; (c) operational analyses; (d) facilitating the exchange of information between Member States, Europol, other Union bodies, third countries and international organisations. 3. Processing for the purpose of operational analyses as referred to in point (c) of paragraph 2 shall be performed by means of operational analysis projects, in respect of which the following specific safeguards shall apply: (a) for every operational analysis project, the Executive Director shall define the specific purpose, categories of personal data and categories of data subjects, participants, duration of storage and conditions for access, transfer and use of the data concerned, and shall inform the Management Board and the EDPS thereof; (b) personal data may only be collected and processed for the purpose of the specified operational analysis project. Where it becomes apparent that personal data may be relevant for another operational analysis project, further processing of that personal data shall only be permitted insofar as such further processing is necessary and proportionate and the personal data are compatible with the provisions set out in point (a) that apply to the other analysis project; (c) only authorised staff may access and process the data of the relevant project. 4. The processing referred to in paragraphs 2 and 3 shall be carried out in compliance with the data protection safeguards provided for in this Regulation. Europol shall duly document those processing operations. The documentation shall be made available, upon request, to the Data Protection Officer and to the EDPS for the purpose of verifying the lawfulness of the processing operations. 5. Categories of personal data and categories of data subjects whose data may be collected and processed for each purpose referred to in paragraph 2 are listed in Annex II. 6. Europol may temporarily process data for the purpose of determining whether such data are relevant to its tasks and, if so, for which of the purposes referred to in paragraph 2. The Management Board, acting on a proposal from the Executive Director and after consulting the EDPS, shall further specify the conditions relating to the processing of such data, in particular with respect to access to and use of the data, as well as time limits for the storage and deletion of the data, which may not exceed six months, having due regard to the principles referred to in Article 28. 7. The Management Board, after consulting the EDPS, shall, as appropriate, adopt guidelines further specifying procedures for the processing of information for the purposes listed in paragraph 2 in accordance with point (q) of Article 11(1). Article 19 Determination of the purpose of, and restrictions on, the processing of information by Europol 1. A Member State, a Union body, a third country or an international organisation providing information to Europol shall determine the purpose or purposes for which it is to be processed, as referred to in Article 18. If it has not done so, Europol, in agreement with the provider of the information concerned, shall process the information in order to determine the relevance of such information as well as the purpose or purposes for which it is to be further processed. Europol may process information for a purpose different from that for which information has been provided only if authorised so to do by the provider of the information. 2. Member States, Union bodies, third countries and international organisations may indicate, at the moment of providing information to Europol, any restriction on access thereto or the use to be made thereof, in general or specific terms, including as regards its transfer, erasure or destruction. Where the need for such restrictions becomes apparent after the information has been provided, they shall inform Europol accordingly. Europol shall comply with such restrictions. 3. In duly justified cases Europol may assign restrictions to access or use by Member States, Union bodies, third countries and international organisations of information retrieved from publicly available sources. Article 20 Access by Member States and Europol's staff to information stored by Europol 1. Member States shall, in accordance with their national law and Article 7(5), have access to, and be able to search, all information which has been provided for the purposes of points (a) and (b) of Article 18(2). This shall be without prejudice to the right of Member States, Union bodies, third countries and international organisations to indicate any restrictions in accordance with Article 19(2). 2. Member States shall, in accordance with their national law and Article 7(5), have indirect access on the basis of a hit/no hit system to information provided for the purposes of point (c) of Article 18(2). This shall be without prejudice to any restrictions indicated by the Member States, Union bodies and third countries or international organisations providing the information, in accordance with Article 19(2). In the case of a hit, Europol shall initiate the procedure by which the information that generated the hit may be shared, in accordance with the decision of the provider of the information to Europol. 3. In accordance with national law, the information referred to in paragraphs 1 and 2 shall be accessed and further processed by Member States only for the purpose of preventing and combating: (a) forms of crime in respect of which Europol is competent; and (b) other forms of serious crime, as set out in Council Framework Decision 2002/584/JHA (22). 4. Europol staff duly empowered by the Executive Director shall have access to information processed by Europol to the extent required for the performance of their duties and without prejudice to Article 67. Article 21 Access by Eurojust and OLAF to information stored by Europol 1. Europol shall take all appropriate measures to enable Eurojust and OLAF, within their respective mandates, to have indirect access on the basis of a hit/no hit system to information provided for the purposes of points (a), (b) and (c) of Article 18(2), without prejudice to any restrictions indicated by the Member State, Union body, third country or international organisation providing the information in question, in accordance with Article 19(2). In the case of a hit, Europol shall initiate the procedure by which the information that generated the hit may be shared, in accordance with the decision of the provider of the information to Europol, and only to the extent that the data generating the hit are necessary for the performance of Eurojust's or OLAF's tasks. 2. Europol and Eurojust may conclude a working arrangement ensuring, in a reciprocal manner and within their respective mandates, access to, and the possibility of searching, all information that has been provided for the purpose specified in point (a) of Article 18(2). This shall be without prejudice to the right of Member States, Union bodies, third countries and international organisations to indicate restrictions on access to, and the use of, such data, and shall be in accordance with the data protection guarantees provided for in this Regulation. 3. Searches of information in accordance with paragraphs 1 and 2 shall be carried out only for the purpose of identifying whether information available at Eurojust or OLAF matches with information processed at Europol. 4. Europol shall allow searches in accordance with paragraphs 1 and 2 only after obtaining from Eurojust information on which National Members, Deputies and Assistants, as well as Eurojust staff members, and from OLAF information on which OLAF staff members, have been designated as authorised to perform such searches. 5. If, during Europol's information-processing activities in respect of an individual investigation, Europol or a Member State identifies the need for coordination, cooperation or support in accordance with the mandate of Eurojust or OLAF, Europol shall notify them to that effect and shall initiate the procedure for sharing the information, in accordance with the decision of the Member State providing the information. In such a case, Eurojust or OLAF shall consult with Europol. 6. Eurojust, including the College, the National Members, Deputies and Assistants, as well as Eurojust staff members, and OLAF, shall respect any restriction on access or use, in general or specific terms, indicated by Member States, Union bodies, third countries and international organisations in accordance with Article 19(2). 7. Europol, Eurojust and OLAF shall inform each other if, after consulting each other's data in accordance with paragraph 2 or as a result of a hit in accordance with paragraph 1, there are indications that data may be incorrect or may conflict with other data. Article 22 Duty to notify Member States 1. Europol shall, in accordance with point (b) of Article 4(1), notify a Member State without delay of any information concerning it. If such information is subject to access restrictions pursuant to Article 19(2) that would prohibit its being shared, Europol shall consult with the provider of the information stipulating the access restriction and seek its authorisation for sharing. In such a case, the information shall not be shared without an explicit authorisation by the provider. 2. Irrespective of any access restrictions, Europol shall notify a Member State of any information concerning it if this is absolutely necessary in the interest of preventing an imminent threat to life. In such a case, Europol shall at the same time notify the provider of the information about the sharing of the information and justify its analysis of the situation. CHAPTER V RELATIONS WITH PARTNERS SECTION 1 Common provisions Article 23 Common provisions 1. In so far as necessary for the performance of its tasks, Europol may establish and maintain cooperative relations with Union bodies in accordance with the objectives of those bodies, the authorities of third countries, international organisations and private parties. 2. Subject to any restriction pursuant to Article 19(2) and without prejudice to Article 67, Europol may directly exchange all information, with the exception of personal data, with entities referred to in paragraph 1 of this Article, in so far as such an exchange is relevant for the performance of Europol's tasks. 3. The Executive Director shall inform the Management Board about any regular cooperative relations which Europol intends to establish and maintain in accordance with paragraphs 1 and 2, and about the development of such relations once established. 4. For the purposes set out in paragraphs 1 and 2, Europol may conclude working arrangements with entities referred to in paragraph 1. Such working arrangements shall not allow the exchange of personal data and shall not bind the Union or its Member States. 5. Europol may receive and process personal data from entities referred to in paragraph 1 insofar as necessary and proportionate for the legitimate performance of its tasks and subject to the provisions of this Chapter. 6. Without prejudice to Article 30(5), personal data shall only be transferred by Europol to Union bodies, third countries and international organisations if necessary for preventing and combating crime falling within the scope of Europol's objectives and in accordance with this Regulation, and if the recipient gives an undertaking that the data will be processed only for the purpose for which they were transferred. If the data to be transferred have been provided by a Member State, Europol shall seek that Member State's consent, unless the Member State has granted its prior authorisation to such onward transfer, either in general terms or subject to specific conditions. Such consent may be withdrawn at any time. 7. Onward transfers of personal data held by Europol by Member States, Union bodies, third countries and international organisations shall be prohibited, unless Europol has given its prior explicit authorisation. 8. Europol shall ensure that detailed records of all transfers of personal data and of the grounds for such transfers are recorded in accordance with this Regulation. 9. Any information which has clearly been obtained in obvious violation of human rights shall not be processed. SECTION 2 Transfer and exchange of personal data Article 24 Transfer of personal data to Union bodies Subject to any possible restrictions pursuant to Article 19(2) or (3) and without prejudice to Article 67, Europol may directly transfer personal data to a Union body, insofar as such transfer is necessary for the performance of its tasks or those of the recipient Union body. Article 25 Transfer of personal data to third countries and international organisations 1. Subject to any possible restrictions pursuant to Article 19(2) or (3) and without prejudice to Article 67, Europol may transfer personal data to an authority of a third country or to an international organisation, insofar as such transfer is necessary for the performance of Europol's tasks, on the basis of one of the following: (a) a decision of the Commission adopted in accordance with Article 36 of Directive (EU) 2016/680, finding that the third country or a territory or a processing sector within that third country or the international organisation in question ensures an adequate level of protection (\u2018adequacy decision\u2019); (b) an international agreement concluded between the Union and that third country or international organisation pursuant to Article 218 TFEU adducing adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals; (c) a cooperation agreement allowing for the exchange of personal data concluded, before 1 May 2017, between Europol and that third country or international organisation in accordance with Article 23 of Decision 2009/371/JHA. Europol may conclude administrative arrangements to implement such agreements or adequacy decisions. 2. The Executive Director shall inform the Management Board about exchanges of personal data on the basis of adequacy decisions pursuant to point (a) of paragraph 1. 3. Europol shall publish on its website and keep up to date a list of adequacy decisions, agreements, administrative arrangements and other instruments relating to the transfer of personal data in accordance with paragraph 1. 4. By 14 June 2021, the Commission shall assess the provisions contained in the cooperation agreements referred to in point (c) of paragraph 1, in particular those concerning data protection. The Commission shall inform the European Parliament and the Council about the outcome of that assessment, and may, if appropriate, submit to the Council a recommendation for a decision authorising the opening of negotiations for the conclusion of international agreements referred to in point (b) of paragraph (1). 5. By way of derogation from paragraph 1, the Executive Director may authorise the transfer of personal data to third countries or international organisations on a case-by-case basis if the transfer is: (a) necessary in order to protect the vital interests of the data subject or of another person; (b) necessary to safeguard legitimate interests of the data subject where the law of the Member State transferring the personal data so provides; (c) essential for the prevention of an immediate and serious threat to the public security of a Member State or a third country; (d) necessary in individual cases for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal sanctions; or (e) necessary in individual cases for the establishment, exercise or defence of legal claims relating to the prevention, investigation, detection or prosecution of a specific criminal offence or the execution of a specific criminal sanction. Personal data shall not be transferred if the Executive Director determines that fundamental rights and freedoms of the data subject concerned override the public interest in the transfer referred to in points (d) and (e). Derogations may not be applicable to systematic, massive or structural transfers. 6. By way of derogation from paragraph 1, the Management Board may, in agreement with the EDPS, authorise for a period not exceeding one year, which shall be renewable, a set of transfers in accordance with points (a) to (e) of paragraph 5, taking into account the existence of adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals. Such authorisation shall be duly justified and documented. 7. The Executive Director shall as soon as possible inform the Management Board and the EDPS of the cases in which paragraph 5 has been applied. 8. Europol shall keep detailed records of all transfers made pursuant to this Article. Article 26 Exchanges of personal data with private parties 1. Insofar as is necessary in order for Europol to perform its tasks, Europol may process personal data obtained from private parties on condition that they are received via: (a) a national unit in accordance with national law; (b) the contact point of a third country or an international organisation with which Europol has concluded, before 1 May 2017, a cooperation agreement allowing for the exchange of personal data in accordance with Article 23 of Decision 2009/371/JHA; or (c) an authority of a third country or an international organisation which is the subject of an adequacy decision as referred to in point (a) of Article 25(1) of this Regulation or with which the Union has concluded an international agreement pursuant to Article 218 TFEU. 2. In cases where Europol nonetheless receives personal data directly from private parties and where the national unit, contact point or authority concerned, as referred to in paragraph 1, cannot be identified, Europol may process those personal data solely for the purpose of such identification. Subsequently, the personal data shall be forwarded immediately to the national unit, contact point or authority concerned and shall be deleted unless the national unit, contact point or authority concerned resubmits those personal data in accordance with Article 19(1) within four months after the transfer takes place. Europol shall ensure by technical means that, during that period, the data in question are not accessible for processing for any other purpose. 3. Following the transfer of personal data in accordance with point (c) of paragraph 5 of this Article, Europol may in connection therewith receive personal data directly from a private party which that private party declares it is legally allowed to transmit in accordance with the applicable law, in order to process such data for the performance of the task set out in point (m) of Article 4(1). 4. If Europol receives personal data from a private party in a third country with which there is no agreement concluded either on the basis of Article 23 of Decision 2009/371/JHA or on the basis of Article 218 TFEU, or which is not the subject of an adequacy decision as referred to in point (a) of Article 25(1) of this Regulation, Europol may forward those data only to a Member State, or to a third country concerned with which such an agreement has been concluded. 5. Europol may not transfer personal data to private parties except where, on a case-by-case basis where strictly necessary and subject to any possible restrictions stipulated pursuant to Article 19(2) or (3) and without prejudice to Article 67: (a) the transfer is undoubtedly in the interests of the data subject, and either the data subject's consent has been given or the circumstances allow a clear presumption of consent; or (b) the transfer is absolutely necessary in the interests of preventing the imminent perpetration of a crime, including terrorism, for which Europol is competent; or (c) the transfer of personal data which are publicly available is strictly necessary for the performance of the task set out in point (m) of Article 4(1) and the following conditions are met: (i) the transfer concerns an individual and specific case; and (ii) no fundamental rights and freedoms of the data subjects concerned override the public interest necessitating the transfer in the case at hand. 6. With regard to points (a) and (b) of paragraph 5 of this Article, if the private party concerned is not established within the Union or in a country with which Europol has a cooperation agreement allowing for the exchange of personal data, with which the Union has concluded an international agreement pursuant to Article 218 TFEU or which is the subject of an adequacy decision as referred to in point (a) of Article 25(1) of this Regulation, the transfer shall only be authorised if the transfer is: (a) necessary in order to protect the vital interests of the data subject or another person; or (b) necessary in order to safeguard legitimate interests of the data subject; or (c) essential for the prevention of an immediate and serious threat to public security of a Member State or a third country; or (d) necessary in individual cases for the purposes of the prevention, investigation, detection or prosecution of criminal offences for which Europol is competent; or (e) necessary in individual cases for the establishment, exercise or defence of legal claims relating to the prevention, investigation, detection or prosecution of a specific criminal offence for which Europol is competent. 7. Europol shall ensure that detailed records of all transfers of personal data and the grounds for such transfers are recorded in accordance with this Regulation and communicated upon request to the EDPS pursuant to Article 40. 8. If the personal data received or to be transferred affect the interests of a Member State, Europol shall immediately inform the national unit of the Member State concerned. 9. Europol shall not contact private parties to retrieve personal data. 10. The Commission shall evaluate the practice of direct exchanges of personal data with private parties by 1 May 2019. Article 27 Information from private persons 1. Insofar as is necessary in order for Europol to perform its tasks, Europol may receive and process information originating from private persons. Personal data originating from private persons may only be processed by Europol on condition that they are received via: (a) a national unit in accordance with national law; (b) the contact point of a third country or an international organisation with which Europol has concluded, before 1 May 2017, a cooperation agreement allowing for the exchange of personal data in accordance with Article 23 of Decision 2009/371/JHA; or (c) an authority of a third country or an international organisation which is the subject of an adequacy decision as referred to in point (a) of Article 25(1) or with which the Union has concluded an international agreement pursuant to Article 218 TFEU. 2. If Europol receives information, including personal data, from a private person residing in a third country with which there is no international agreement concluded either on the basis of Article 23 of Decision 2009/371/JHA or on the basis of Article 218 TFEU, or which is not the subject of an adequacy decision as referred to in point (a) of Article 25(1) of this Regulation, Europol may only forward that information to a Member State or to a third country concerned with which such an international agreement has been concluded. 3. If the personal data received affect the interests of a Member State, Europol shall immediately inform the national unit of the Member State concerned. 4. Europol shall not contact private persons to retrieve information. 5. Without prejudice to Articles 36 and 37, Europol may not transfer personal data to private persons. CHAPTER VI DATA PROTECTION SAFEGUARDS Article 28 General data protection principles 1. Personal data shall be: (a) processed fairly and lawfully; (b) collected for specified, explicit and legitimate purposes and not further processed in a manner incompatible with those purposes. Further processing of personal data for historical, statistical or scientific research purposes shall not be considered incompatible provided that Europol provides appropriate safeguards, in particular to ensure that data are not processed for any other purposes; (c) adequate, relevant, and limited to what is necessary in relation to the purposes for which they are processed; (d) accurate and kept up to date; every reasonable step must be taken to ensure that personal data that are inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay; (e) kept in a form which permits identification of data subjects for no longer than necessary for the purposes for which the personal data are processed; and (f) processed in a manner that ensures appropriate security of personal data. 2. Europol shall make publicly available a document setting out in an intelligible form the provisions regarding the processing of personal data and the means available for the exercise of the rights of data subjects. Article 29 Assessment of reliability of the source and accuracy of information 1. The reliability of the source of information originating from a Member State shall be assessed as far as possible by the providing Member State using the following source evaluation codes: (A): where there is no doubt as to the authenticity, trustworthiness and competence of the source, or if the information is provided by a source which has proved to be reliable in all instances; (B): where the information is provided by a source which has in most instances proved to be reliable; (C): where the information is provided by a source which has in most instances proved to be unreliable; (X): where the reliability of the source cannot be assessed. 2. The accuracy of information originating from a Member State shall be assessed as far as possible by the providing Member State using the following information evaluation codes: (1): information the accuracy of which is not in doubt; (2): information known personally to the source but not known personally to the official passing it on; (3): information not known personally to the source but corroborated by other information already recorded; (4): information not known personally to the source and which cannot be corroborated. 3. Where Europol, on the basis of information already in its possession, comes to the conclusion that the assessment provided for in paragraphs 1 or 2 needs to be corrected, it shall inform the Member State concerned and seek to agree on an amendment to the assessment. Europol shall not change the assessment without such agreement. 4. Where Europol receives information from a Member State without an assessment in accordance with paragraphs 1 or 2, it shall attempt to assess the reliability of the source or the accuracy of information on the basis of information already in its possession. The assessment of specific data and information shall take place in agreement with the providing Member State. A Member State may also agree with Europol in general terms on the assessment of specified types of data and specified sources. If no agreement is reached in a specific case, or no agreement in general terms exists, Europol shall assess the information or data and shall attribute to such information or data the evaluation codes (X) and (4) referred to in paragraphs 1 and 2 respectively. 5. This Article shall apply mutatis mutandis where Europol receives data or information from a Union body, third country, international organisation or private party. 6. Information from publicly available sources shall be assessed by Europol using the evaluation codes set out in paragraphs 1 and 2. 7. Where information is the result of an analysis made by Europol in the performance of its tasks, Europol shall assess such information in accordance with this Article, and in agreement with the Member States participating in the analysis. Article 30 Processing of special categories of personal data and of different categories of data subjects 1. Processing of personal data in respect of victims of a criminal offence, witnesses or other persons who can provide information concerning criminal offences, or in respect of persons under the age of 18, shall be allowed if it is strictly necessary and proportionate for preventing or combating crime that falls within Europol's objectives. 2. Processing of personal data, by automated or other means, revealing racial or ethnic origin, political opinions, religious or philosophical beliefs or trade union membership and processing of genetic data or data concerning a person's health or sex life shall be prohibited, unless it is strictly necessary and proportionate for preventing or combating crime that falls within Europol's objectives and if those data supplement other personal data processed by Europol. The selection of a particular group of persons solely on the basis of such personal data shall be prohibited. 3. Only Europol shall have direct access to personal data as referred to in paragraphs 1 and 2. The Executive Director shall duly authorise a limited number of Europol officials to have such access if it is necessary for the performance of their tasks. 4. No decision by a competent authority which produces adverse legal effects concerning a data subject shall be based solely on automated processing of data as referred to in paragraph 2, unless the decision is expressly authorised pursuant to national or Union legislation. 5. Personal data as referred to in paragraphs 1 and 2 shall not be transmitted to Member States, Union bodies, third countries or international organisations unless such transmission is strictly necessary and proportionate in individual cases concerning crime that falls within Europol's objectives and in accordance with Chapter V. 6. Every year Europol shall provide to the EDPS a statistical overview of all personal data as referred to in paragraph 2 which it has processed. Article 31 Time-limits for the storage and erasure of personal data 1. Personal data processed by Europol shall be stored by Europol only for as long as is necessary and proportionate for the purposes for which the data are processed. 2. Europol shall in any event review the need for continued storage no later than three years after the start of initial processing of personal data. Europol may decide on the continued storage of personal data until the following review, which shall take place after another period of three years, if continued storage is still necessary for the performance of Europol's tasks. The reasons for the continued storage shall be justified and recorded. If no decision is taken on the continued storage of personal data, that data shall be erased automatically after three years. 3. If personal data as referred to in Article 30(1) and (2) are stored for a period exceeding five years, the EDPS shall be informed accordingly. 4. Where a Member State, a Union body, a third country or an international organisation has indicated any restriction as regards the earlier erasure or destruction of the personal data at the moment of transfer in accordance with Article 19(2), Europol shall erase the personal data in accordance with those restrictions. If continued storage of the data is deemed necessary, on the basis of information that is more extensive than that possessed by the data provider, in order for Europol to perform its tasks, Europol shall request the authorisation of the data provider to continue storing the data and shall present a justification for such request. 5. Where a Member State, a Union body, a third country or an international organisation erases from its own data files personal data provided to Europol, it shall inform Europol accordingly. Europol shall erase the data unless the continued storage of the data is deemed necessary, on the basis of information that is more extensive than that possessed by the data provider, in order for Europol to perform its tasks. Europol shall inform the data provider of the continued storage of such data and present a justification of such continued storage. 6. Personal data shall not be erased if: (a) this would damage the interests of a data subject who requires protection. In such cases, the data shall be used only with the express and written consent of the data subject; (b) their accuracy is contested by the data subject, for a period enabling Member States or Europol, where appropriate, to verify the accuracy of the data; (c) they have to be maintained for purposes of proof or for the establishment, exercise or defence of legal claims; or (d) the data subject opposes their erasure and requests the restriction of their use instead. Article 32 Security of processing 1. Europol shall implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction, accidental loss or unauthorised disclosure, alteration and access or any other unauthorised form of processing. 2. In respect of automated data processing, Europol and each Member State shall implement measures designed to: (a) deny unauthorised persons access to data-processing equipment used for processing personal data (equipment access control); (b) prevent the unauthorised reading, copying, modification or removal of data media (data media control); (c) prevent the unauthorised input of data and the unauthorised inspection, modification or deletion of stored personal data (storage control); (d) prevent the use of automated data-processing systems by unauthorised persons using data-communication equipment (user control); (e) ensure that persons authorised to use an automated data-processing system have access only to data covered by their access authorisation (data access control); (f) ensure that it is possible to verify and establish to which bodies personal data may be or have been transmitted using data-communication equipment (communication control); (g) ensure that it is possible to verify and establish which personal data have been input into automated data-processing systems and when and by whom the data were input (input control); (h) ensure that it is possible to verify and establish what data have been accessed by which member of personnel and at what time (access log); (i) prevent the unauthorised reading, copying, modification or deletion of personal data during transfers of personal data or during the transportation of data media (transport control); (j) ensure that it is possible, in the event of interruption, to restore installed systems immediately (recovery); and (k) ensure that the functions of the system perform faultlessly, that the occurrence of faults in the functions is immediately reported (reliability) and that stored data cannot be corrupted by system malfunctions (integrity). 3. Europol and Member States shall establish mechanisms to ensure that security needs are taken on board across information system boundaries. Article 33 Data protection by design Europol shall implement appropriate technical and organisational measures and procedures in such a way that the data processing will comply with this Regulation and protect the rights of the data subjects concerned. Article 34 Notification of a personal data breach to the authorities concerned 1. In the event of a personal data breach, Europol shall without undue delay notify the EDPS, as well as the competent authorities of the Member States concerned, of that breach, in accordance with the conditions laid down in Article 7(5),as well as the provider of the data concerned. 2. The notification referred to in paragraph 1 shall, as a minimum: (a) describe the nature of the personal data breach including, where possible and appropriate, the categories and number of data subjects concerned and the categories and number of data records concerned; (b) describe the likely consequences of the personal data breach; (c) describe the measures proposed or taken by Europol to address the personal data breach; and (d) where appropriate, recommend measures to mitigate the possible adverse effects of the personal data breach. 3. Europol shall document any personal data breaches, including the facts surrounding the breach, its effects and the remedial action taken, thereby enabling the EDPS to verify compliance with this Article. Article 35 Communication of a personal data breach to the data subject 1. Subject to paragraph 4 of this Article, where a personal data breach as referred to in Article 34 is likely to severely and adversely affect the rights and freedoms of the data subject, Europol shall communicate the personal data breach to the data subject without undue delay. 2. The communication to the data subject referred to in paragraph 1 shall describe, where possible, the nature of the personal data breach, recommend measures to mitigate the possible adverse effects of the personal data breach, and contain the identity and contact details of the Data Protection Officer. 3. If Europol does not have the contact details of the data subject concerned, it shall request the provider of the data to communicate the personal data breach to the data subject concerned and to inform Europol about the decision taken. Member States providing the data shall communicate the breach to the data subject concerned in accordance with the procedures of their national law. 4. The communication of a personal data breach to the data subject shall not be required if: (a) Europol has applied to the personal data concerned by that breach appropriate technological protection measures that render the data unintelligible to any person who is not authorised to access it; (b) Europol has taken subsequent measures which ensure that the data subject's rights and freedoms are no longer likely to be severely affected; or (c) such communication would involve disproportionate effort, in particular owing to the number of cases involved. In such a case, there shall instead be a public communication or similar measure informing the data subjects concerned in an equally effective manner. 5. The communication to the data subject may be delayed, restricted or omitted where this constitutes a necessary measure with due regard for the legitimate interests of the person concerned: (a) to avoid obstructing official or legal inquiries, investigations or procedures; (b) to avoid prejudicing the prevention, detection, investigation and prosecution of criminal offences or for the execution of criminal penalties; (c) to protect public and national security; (d) to protect the rights and freedoms of third parties. Article 36 Right of access for the data subject 1. Any data subject shall have the right, at reasonable intervals, to obtain information on whether personal data relating to him or her are processed by Europol. 2. Without prejudice to paragraph 5, Europol shall provide the following information to the data subject: (a) confirmation as to whether or not data related to him or her are being processed; (b) information on at least the purposes of the processing operation, the categories of data concerned, and the recipients or categories of recipients to whom the data are disclosed; (c) communication in an intelligible form of the data undergoing processing and of any available information as to their sources; (d) an indication of the legal basis for processing the data; (e) the envisaged period for which the personal data will be stored; (f) the existence of the right to request from Europol rectification, erasure or restriction of processing of personal data concerning the data subject. 3. Any data subject wishing to exercise the right of access to personal data relating to him or her may make a request to that effect, without incurring excessive costs, to the authority appointed for that purpose in the Member State of his or her choice. That authority shall refer the request to Europol without delay, and in any case within one month of receipt. 4. Europol shall confirm receipt of the request under paragraph 3. Europol shall answer it without undue delay, and in any case within three months of receipt by Europol of the request from the national authority. 5. Europol shall consult the competent authorities of the Member States, in accordance with the conditions laid down in Article 7(5), and the provider of the data concerned, on a decision to be taken. A decision on access to personal data shall be conditional on close cooperation between Europol and the Member States and the provider of the data directly concerned by the access of the data subject to such data. If a Member State or the provider of the data objects to Europol's proposed response, it shall notify Europol of the reasons for its objection in accordance with paragraph 6 of this Article. Europol shall take the utmost account of any such objection. Europol shall subsequently notify its decision to the competent authorities concerned, in accordance with the conditions laid down in Article 7(5), and to the provider of the data. 6. The provision of information in response to any request under paragraph 1 may be refused or restricted if such refusal or restriction constitutes a measure that is necessary in order to: (a) enable Europol to fulfil its tasks properly; (b) protect security and public order or prevent crime; (c) guarantee that any national investigation will not be jeopardised; or (d) protect the rights and freedoms of third parties. When the applicability of an exemption is assessed, the fundamental rights and interests of the data subject shall be taken into account. 7. Europol shall inform the data subject in writing of any refusal or restriction of access, of the reasons for such a decision and of his or her right to lodge a complaint with the EDPS. Where the provision of such information would deprive paragraph 6 of its effect, Europol shall only notify the data subject concerned that it has carried out the checks, without giving any information which might reveal to him or her whether or not personal data concerning him or her are processed by Europol. Article 37 Right to rectification, erasure and restriction 1. Any data subject having accessed personal data concerning him or her processed by Europol in accordance with Article 36 shall have the right to request Europol, through the authority appointed for that purpose in the Member State of his or her choice, to rectify personal data concerning him or her held by Europol if they are incorrect or to complete or update them. That authority shall refer the request to Europol without delay and in any case within one month of receipt. 2. Any data subject having accessed personal data concerning him or her processed by Europol in accordance with Article 36 shall have the right to request Europol, through the authority appointed for that purpose in the Member State of his or her choice, to erase personal data relating to him or her held by Europol if they are no longer required for the purposes for which they are collected or are further processed. That authority shall refer the request to Europol without delay and in any case within one month of receipt. 3. Europol shall restrict rather than erase personal data as referred to in paragraph 2 if there are reasonable grounds to believe that erasure could affect the legitimate interests of the data subject. Restricted data shall be processed only for the purpose that prevented their erasure. 4. If personal data as referred to in paragraphs 1, 2 and 3 held by Europol have been provided to it by third countries, international organisations or Union bodies, have been directly provided by private parties or have been retrieved by Europol from publicly available sources or result from Europol's own analyses, Europol shall rectify, erase or restrict such data and, where appropriate, inform the providers of the data. 5. If personal data as referred to in paragraphs 1, 2 and 3 held by Europol have been provided to Europol by Member States, the Member States concerned shall rectify, erase or restrict such data in collaboration with Europol, within their respective competences. 6. If incorrect personal data have been transferred by another appropriate means or if the errors in the data provided by Member States are due to faulty transfer or transfer in breach of this Regulation or if they result from data being input, taken over or stored in an incorrect manner or in breach of this Regulation by Europol, Europol shall rectify or erase such data in collaboration with the provider of the data concerned. 7. In the cases referred to in paragraphs 4, 5 and 6, all addressees of the data concerned shall be notified forthwith. In accordance with the rules applicable to them, the addressees shall then rectify, erase or restrict those data in their systems. 8. Europol shall inform the data subject in writing without undue delay, and in any case within three months of receipt of a request in accordance with paragraph 1 or 2, that data concerning him or her have been rectified, erased or restricted. 9. Within three months of receipt of a request in accordance with paragraph 1 or 2, Europol shall inform the data subject in writing of any refusal of rectification, erasure or restricting, of the reasons for such a refusal and of the possibility of lodging a complaint with the EDPS and of seeking a judicial remedy. Article 38 Responsibility in data protection matters 1. Europol shall store personal data in a way that ensures that their source, as referred to in Article 17, can be established. 2. The responsibility for the quality of personal data as referred to in point (d) of Article 28(1) shall lie with: (a) the Member State or the Union body which provided the personal data to Europol; (b) Europol in respect of personal data provided by third countries or international organisations or directly provided by private parties; of personal data retrieved by Europol from publicly available sources or resulting from Europol's own analyses; and of personal data stored by Europol in accordance with Article 31(5). 3. If Europol becomes aware that personal data provided pursuant to points (a) and (b) of Article 17(1) are factually incorrect or have been unlawfully stored, it shall inform the provider of those data accordingly. 4. Europol shall be responsible for compliance with the principles referred to in points (a), (b), (c), (e) and (f) of Article 28(1). 5. The responsibility for the legality of a data transfer shall lie with: (a) the Member State which provided the personal data to Europol; (b) Europol in the case of personal data provided by it to Member States, third countries or international organisations. 6. In the case of a transfer between Europol and a Union body, the responsibility for the legality of the transfer shall lie with Europol. Without prejudice to the first subparagraph, where the data are transferred by Europol following a request from the recipient, both Europol and the recipient shall be responsible for the legality of such a transfer. 7. Europol shall be responsible for all data processing operations carried out by it, with the exception of the bilateral exchange of data using Europol's infrastructure between Member States, Union bodies, third countries and international organisations to which Europol has no access. Such bilateral exchanges shall take place under the responsibility of the entities concerned and in accordance with their law. The security of such exchanges shall be ensured in accordance with Article 32. Article 39 Prior consultation 1. Any new type of processing operations to be carried out shall be subject to prior consultation where: (a) special categories of data as referred to in Article 30(2) are to be processed; (b) the type of processing, in particular using new technologies, mechanisms or procedures, presents specific risks for the fundamental rights and freedoms, and in particular the protection of personal data, of data subjects. 2. The prior consultation shall be carried out by the EDPS following receipt of a notification from the Data Protection Officer that shall contain at least a general description of the envisaged processing operations, an assessment of the risks to the rights and freedoms of data subjects, the measures envisaged to address those risks, safeguards and security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with this Regulation, taking into account the rights and legitimate interests of the data subjects and other persons concerned. 3. The EDPS shall deliver his or her opinion to the Management Board within two months following receipt of the notification. That period may be suspended until the EDPS has obtained any further information that he or she may have requested. If the opinion has not been delivered after four months it shall be deemed to be favourable. If the opinion of the EDPS is that the notified processing may involve a breach of any provision of this Regulation, he or she shall, where appropriate, make proposals to avoid such a breach. Where Europol does not modify the processing operation accordingly, the EDPS may exercise the powers granted to him or her under Article 43(3). 4. The EDPS shall keep a register of all processing operations that have been notified to him or her pursuant to paragraph 1. The register shall not be made public. Article 40 Logging and documentation 1. For the purpose of verifying the lawfulness of data processing, self-monitoring and ensuring proper data integrity and security, Europol shall keep records of the collection, alteration, access, disclosure, combination or erasure of personal data. Such logs or documentation shall be deleted after three years, unless the data which they contain are further required for ongoing control. There shall be no possibility of modifying the logs. 2. Logs or documentation prepared pursuant to paragraph 1 shall be communicated upon request to the EDPS, to the Data Protection Officer and, if required for a specific investigation, to the national unit concerned. The information thus communicated shall only be used for the control of data protection and for ensuring proper data processing as well as data integrity and security. Article 41 Data Protection Officer 1. The Management Board shall appoint a Data Protection Officer, who shall be a member of the staff. In the performance of his or her duties, he or she shall act independently. 2. The Data Protection Officer shall be selected on the basis of his or her personal and professional qualities and, in particular, the expert knowledge of data protection. It shall be ensured in the selection of the Data Protection Officer that no conflict of interest may result from the performance of his or her duty in that capacity and from any other official duties, in particular those relating to the application of this Regulation. 3. The Data Protection Officer shall be appointed for a term of four years. He or she shall be eligible for reappointment up to a maximum total term of eight years. He or she may be dismissed from his or her function as Data Protection Officer by the Management Board only with the consent of the EDPS, if he or she no longer meets the conditions required for the performance of his or her duties. 4. After his or her appointment, the Data Protection Officer shall be registered with the EDPS by the Management Board. 5. With respect to the performance of his or her duties, the Data Protection Officer shall not receive any instructions. 6. The Data Protection Officer shall, in particular, have the following tasks with regard to personal data, with the exception of administrative personal data: (a) ensuring, in an independent manner, the internal application of this Regulation concerning the processing of personal data; (b) ensuring that a record of the transfer and receipt of personal data is kept in accordance with this Regulation; (c) ensuring that data subjects are informed of their rights under this Regulation at their request; (d) cooperating with Europol staff responsible for procedures, training and advice on data processing; (e) cooperating with the EDPS; (f) preparing an annual report and communicating that report to the Management Board and to the EDPS; (g) keeping a register of personal data breaches. 7. The Data Protection Officer shall also carry out the functions provided for by Regulation (EC) No 45/2001 with regard to administrative personal data. 8. In the performance of his or her tasks, the Data Protection Officer shall have access to all the data processed by Europol and to all Europol premises. 9. If the Data Protection Officer considers that the provisions of this Regulation concerning the processing of personal data have not been complied with, he or she shall inform the Executive Director and shall require him or her to resolve the non-compliance within a specified time. If the Executive Director does not resolve the non-compliance of the processing within the time specified, the Data Protection Officer shall inform the Management Board. The Data Protection Officer and the Management Board shall agree a specified time for a response by the latter. If the Management Board does not resolve the non-compliance within the time specified, the Data Protection Officer shall refer the matter to the EDPS. 10. The Management Board shall adopt implementing rules concerning the Data Protection Officer. Those implementing rules shall, in particular, concern the selection procedure for the position of the Data Protection Officer and his or her dismissal, tasks, duties and powers, and safeguards ensuring the independence of the Data Protection Officer. 11. Europol shall provide the Data Protection Officer with the staff and resources needed in order for him or her to be able to carry out his or her duties. Those staff members shall have access to all the data processed at Europol and to Europol premises only to the extent necessary for the performance of their tasks. 12. The Data Protection Officer and his or her staff shall be bound by the obligation of confidentiality in accordance with Article 67(1). Article 42 Supervision by the national supervisory authority 1. Each Member State shall designate a national supervisory authority. The national supervisory authority shall have the task of monitoring independently, in accordance with its national law, the permissibility of the transfer, the retrieval and any communication to Europol of personal data by the Member State concerned, and of examining whether such transfer, retrieval or communication violates the rights of the data subjects concerned. For that purpose, the national supervisory authority shall have access, at the national unit or at the liaison officers' premises, to data submitted by its Member State to Europol in accordance with the relevant national procedures and to logs and documentation as referred to in Article 40. 2. For the purpose of exercising their supervisory function, national supervisory authorities shall have access to the offices and documents of their respective liaison officers at Europol. 3. National supervisory authorities shall, in accordance with the relevant national procedures, supervise the activities of national units and the activities of liaison officers, insofar as such activities are relevant to the protection of personal data. They shall also keep the EDPS informed of any actions they take with respect to Europol. 4. Any person shall have the right to request the national supervisory authority to verify the legality of any transfer or communication to Europol of data concerning him or her in any form and of access to those data by the Member State concerned. That right shall be exercised in accordance with the national law of the Member State in which the request is made. Article 43 Supervision by the EDPS 1. The EDPS shall be responsible for monitoring and ensuring the application of the provisions of this Regulation relating to the protection of fundamental rights and freedoms of natural persons with regard to the processing of personal data by Europol, and for advising Europol and data subjects on all matters concerning the processing of personal data. To that end, he or she shall fulfil the duties set out in paragraph 2 and exercise the powers laid down in paragraph 3, while closely cooperating with the national supervisory authorities in accordance with Article 44. 2. The EDPS shall have the following duties: (a) hearing and investigating complaints, and informing the data subject of the outcome within a reasonable period; (b) conducting inquiries either on his or her own initiative or on the basis of a complaint, and informing the data subject of the outcome within a reasonable period; (c) monitoring and ensuring the application of this Regulation and any other Union act relating to the protection of natural persons with regard to the processing of personal data by Europol; (d) advising Europol, either on his or her own initiative or in response to a consultation, on all matters concerning the processing of personal data, in particular before it draws up internal rules relating to the protection of fundamental rights and freedoms with regard to the processing of personal data; (e) keeping a register of new types of processing operations notified to him or her by virtue of Article 39(1) and registered in accordance with Article 39(4); (f) carrying out a prior consultation on processing notified to him or her. 3. The EDPS may pursuant to this Regulation: (a) give advice to data subjects on the exercise of their rights; (b) refer a matter to Europol in the event of an alleged breach of the provisions governing the processing of personal data, and, where appropriate, make proposals for remedying that breach and for improving the protection of the data subjects; (c) order that requests to exercise certain rights in relation to data be complied with where such requests have been refused in breach of Articles 36 and 37; (d) warn or admonish Europol; (e) order Europol to carry out the rectification, restriction, erasure or destruction of personal data which have been processed in breach of the provisions governing the processing of personal data and to notify such actions to third parties to whom such data have been disclosed; (f) impose a temporary or definitive ban on processing operations by Europol which are in breach of the provisions governing the processing of personal data; (g) refer a matter to Europol and, if necessary, to the European Parliament, the Council and the Commission; (h) refer a matter to the Court of Justice of the European Union under the conditions provided for in the TFEU; (i) intervene in actions brought before the Court of Justice of the European Union. 4. The EDPS shall have the power to: (a) obtain from Europol access to all personal data and to all information necessary for his or her enquiries; (b) obtain access to any premises in which Europol carries on its activities when there are reasonable grounds for presuming that an activity covered by this Regulation is being carried out there. 5. The EDPS shall draw up an annual report on the supervisory activities of Europol, after consulting the national supervisory authorities. That report shall be part of the annual report of the EDPS referred to in Article 48 of Regulation (EC) No 45/2001. The report shall include statistical information regarding complaints, inquiries, and investigations carried out in accordance with paragraph 2, as well as regarding transfers of personal data to third countries and international organisations, cases of prior consultation, and the use of the powers laid down in paragraph 3. 6. The EDPS, the officials and the other staff members of the EDPS's Secretariat shall be bound by the obligation of confidentiality laid down in Article 67(1). Article 44 Cooperation between the EDPS and national supervisory authorities 1. The EDPS shall act in close cooperation with the national supervisory authorities on issues requiring national involvement, in particular if the EDPS or a national supervisory authority finds major discrepancies between the practices of Member States or potentially unlawful transfers in the use of Europol's channels for exchanges of information, or in the context of questions raised by one or more national supervisory authorities on the implementation and interpretation of this Regulation. 2. The EDPS shall use the expertise and experience of the national supervisory authorities in carrying out his or her duties as set out in Article 43(2). In carrying out joint inspections together with the EDPS, members and staff of national supervisory authorities shall, taking due account of the principles of subsidiarity and proportionality, have powers equivalent to those laid down in Article 43(4) and be bound by an obligation equivalent to that laid down in Article 43(6). The EDPS and the national supervisory authorities shall, each acting within the scope of their respective competences, exchange relevant information and assist each other in carrying out audits and inspections. 3. The EDPS shall keep national supervisory authorities fully informed of all issues directly affecting or otherwise relevant to them. Upon the request of one or more national supervisory authorities, the EDPS shall inform them of specific issues. 4. In cases relating to data originating from one or more Member States, including the cases referred to in Article 47(2), the EDPS shall consult the national supervisory authorities concerned. The EDPS shall not decide on further action to be taken before those national supervisory authorities have informed the EDPS of their position, within a deadline specified by him or her which shall not be shorter than one month and not longer than three months. The EDPS shall take the utmost account of the respective positions of the national supervisory authorities concerned. In cases where the EDPS intends not to follow the position of a national supervisory authority, he or she shall inform that authority, provide a justification and submit the matter for discussion to the Cooperation Board established by Article 45(1). In cases which the EDPS considers to be extremely urgent, he or she may decide to take immediate action. In such cases, the EDPS shall immediately inform the national supervisory authorities concerned and justify the urgent nature of the situation as well as the action he or she has taken. Article 45 Cooperation Board 1. A Cooperation Board with an advisory function is hereby established. It shall be composed of a representative of a national supervisory authority of each Member State and of the EDPS. 2. The Cooperation Board shall act independently when performing its tasks pursuant to paragraph 3 and shall neither seek nor take instructions from any body. 3. The Cooperation Board shall have the following tasks: (a) discussing general policy and strategy of data protection supervision of Europol and the permissibility of the transfer, the retrieval and any communication to Europol of personal data by the Member States; (b) examining difficulties of interpretation or application of this Regulation; (c) studying general problems relating to the exercise of independent supervision or the exercise of the rights of data subjects; (d) discussing and drawing up harmonised proposals for joint solutions on matters referred to in Article 44(1); (e) discussing cases submitted by the EDPS in accordance with Article 44(4); (f) discussing cases submitted by any national supervisory authority; and (g) promoting awareness of data protection rights. 4. The Cooperation Board may issue opinions, guidelines, recommendations and best practices. The EDPS and the national supervisory authorities shall, without prejudice to their independence and each acting within the scope of their respective competences, take the utmost account of them. 5. The Cooperation Board shall meet whenever necessary, and at least twice a year. The costs and servicing of its meetings shall be borne by the EDPS. 6. Rules of procedure of the Cooperation Board shall be adopted at its first meeting by a simple majority of its members. Further working methods shall be developed jointly as necessary. Article 46 Administrative personal data Regulation (EC) No 45/2001 shall apply to all administrative personal data held by Europol. CHAPTER VII REMEDIES AND LIABILITY Article 47 Right to lodge a complaint with the EDPS 1. Any data subject shall have the right to lodge a complaint with the EDPS if he or she considers that the processing by Europol of personal data relating to him or her does not comply with this Regulation. 2. Where a complaint relates to a decision as referred to in Article 36 or 37, the EDPS shall consult the national supervisory authorities of the Member State that provided the data or the Member State directly concerned. In adopting his or her decision, which may extend to a refusal to communicate any information, the EDPS shall take into account the opinion of the national supervisory authority. 3. Where a complaint relates to the processing of data provided by a Member State to Europol, the EDPS and the national supervisory authority of the Member State that provided the data shall, each acting within the scope of their respective competences, ensure that the necessary checks on the lawfulness of the processing of the data have been carried out correctly. 4. Where a complaint relates to the processing of data provided to Europol by Union bodies, third countries or international organisations, or of data retrieved by Europol from publicly available sources or resulting from Europol's own analyses, the EDPS shall ensure that Europol has correctly carried out the necessary checks on the lawfulness of the processing of the data. Article 48 Right to a judicial remedy against the EDPS Any action against a decision of the EDPS shall be brought before the Court of Justice of the European Union. Article 49 General provisions on liability and the right to compensation 1. Europol's contractual liability shall be governed by the law applicable to the contract in question. 2. The Court of Justice of the European Union shall have jurisdiction to give judgment pursuant to any arbitration clause in a contract concluded by Europol. 3. Without prejudice to Article 49, in the case of non-contractual liability, Europol shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its departments or by its staff in the performance of their duties. 4. The Court of Justice of the European Union shall have jurisdiction in disputes relating to compensation for damage as referred to in paragraph 3. 5. The personal liability of Europol staff vis-\u00e0-vis Europol shall be governed by the provisions laid down in the Staff Regulations or in the Conditions of Employment of Other Servants applicable to them. Article 50 Liability for incorrect personal data processing and the right to compensation 1. Any individual who has suffered damage as a result of an unlawful data processing operation shall have the right to receive compensation for damage suffered, either from Europol in accordance with Article 340 TFEU or from the Member State in which the event that gave rise to the damage occurred, in accordance with its national law. The individual shall bring an action against Europol before the Court of Justice of the European Union, or against the Member State before a competent national court of that Member State. 2. Any dispute between Europol and Member States over the ultimate responsibility for compensation awarded to an individual in accordance with paragraph 1 shall be referred to the Management Board, which shall decide by a majority of two-thirds of its members, without prejudice to the right to challenge that decision in accordance with Article 263 TFEU. CHAPTER VIII JOINT PARLIAMENTARY SCRUTINY Article 51 Joint Parliamentary scrutiny 1. Pursuant to Article 88 TFEU, the scrutiny of Europol's activities shall be carried out by the European Parliament together with national parliaments. This shall constitute a specialised Joint Parliamentary Scrutiny Group (JPSG) established together by the national parliaments and the competent committee of the European Parliament. The organisation and the rules of procedure of the JPSG shall be determined together by the European Parliament and the national parliaments in accordance with Article 9 of Protocol No 1. 2. The JPSG shall politically monitor Europol's activities in fulfilling its mission, including as regards the impact of those activities on the fundamental rights and freedoms of natural persons. For the purposes of the first subparagraph: (a) the Chairperson of the Management Board, the Executive Director or their Deputies shall appear before the JPSG at its request to discuss matters relating to the activities referred to in the first subparagraph, including the budgetary aspects of such activities, the structural organisation of Europol and the potential establishment of new units and specialised centres, taking into account the obligations of discretion and confidentiality. The JPSG may decide to invite to its meetings other relevant persons, where appropriate; (b) the EDPS shall appear before the JPSG at its request, and at least once a year, to discuss general matters relating to the protection of fundamental rights and freedoms of natural persons, and in particular the protection of personal data, with regard to Europol's activities, taking into account the obligations of discretion and confidentiality; (c) the JPSG shall be consulted in relation to the multiannual programming of Europol in accordance with Article 12(1). 3. Europol shall transmit the following documents, for information purposes, to the JPSG, taking into account the obligations of discretion and confidentiality: (a) threat assessments, strategic analyses and general situation reports relating to Europol's objective as well as the results of studies and evaluations commissioned by Europol; (b) the administrative arrangements concluded pursuant to Article 25(1); (c) the document containing the multiannual programming and the annual work programme of Europol, referred to in Article 12(1); (d) the consolidated annual activity report on Europol's activities, referred to in point (c) of Article 11(1); (e) the evaluation report drawn up by the Commission, referred to in Article 68(1). 4. The JPSG may request other relevant documents necessary for the fulfilment of its tasks relating to the political monitoring of Europol's activities, subject to Regulation (EC) No 1049/2001 of the European Parliament and of the Council (23) and without prejudice to Articles 52 and 67 of this Regulation. 5. The JPSG may draw up summary conclusions on the political monitoring of Europol's activities and submit those conclusions to the European Parliament and national parliaments. The European Parliament shall forward them, for information purposes, to the Council, the Commission and Europol. Article 52 Access by the European Parliament to information processed by or through Europol 1. For the purpose of enabling it to exercise parliamentary scrutiny of Europol's activities in accordance with Article 51, access by the European Parliament to sensitive non-classified information processed by or through Europol, upon the European Parliament's request, shall comply with the rules referred to in Article 67(1). 2. Access by the European Parliament to EU classified information processed by or through Europol shall be consistent with the Interinstitutional Agreement of 12 March 2014 between the European Parliament and the Council concerning the forwarding to and the handling by the European Parliament of classified information held by the Council on matters other than those in the area of the common foreign and security policy (24), and shall comply with the rules referred to in Article 67(2) of this Regulation. 3. The necessary details regarding access by the European Parliament to the information referred to in paragraphs 1 and 2 shall be governed by working arrangements concluded between Europol and the European Parliament. CHAPTER IX STAFF Article 53 General provisions 1. The Staff Regulations, the Conditions of Employment of Other Servants and the rules adopted by agreement between the institutions of the Union for giving effect to the Staff Regulations and to the Conditions of Employment of Other Servants shall apply to the staff of Europol with the exception of staff who, on 1 May 2017, are employed pursuant to a contract concluded by Europol as established by the Europol Convention without prejudice to Article 73(4) of this Regulation. Such contracts shall continue to be governed by the Council Act of 3 December 1998. 2. Europol staff shall consist of temporary staff and/or contract staff. The Management Board shall be informed on a yearly basis of contracts of an indefinite duration granted by the Executive Director. The Management Board shall decide which temporary posts provided for in the establishment plan can be filled only by staff from the competent authorities of the Member States. Staff recruited to occupy such posts shall be temporary agents and may be awarded only fixed-term contracts, renewable once for a fixed period. Article 54 Executive Director 1. The Executive Director shall be engaged as a temporary agent of Europol under point (a) of Article 2 of the Conditions of Employment of Other Servants. 2. The Executive Director shall be appointed by the Council from a shortlist of candidates proposed by the Management Board, following an open and transparent selection procedure. The shortlist shall be drawn up by a selection committee set up by the Management Board and composed of members designated by Member States and a Commission representative For the purpose of concluding a contract with the Executive Director, Europol shall be represented by the Chairperson of the Management Board. Before appointment, the candidate selected by the Council may be invited to appear before the competent committee of the European Parliament, which shall subsequently give a non-binding opinion. 3. The term of office of the Executive Director shall be four years. By the end of that period, the Commission, in association with the Management Board, shall undertake an assessment taking into account: (a) an evaluation of the Executive Director's performance, and (b) Europol's future tasks and challenges. 4. The Council, acting on a proposal from the Management Board that takes into account the assessment referred to in paragraph 3, may extend the term of office of the Executive Director once and for no more than four years. 5. The Management Board shall inform the European Parliament if it intends to propose to the Council that the Executive Director's term of office be extended. Within the month before any such extension, the Executive Director may be invited to appear before the competent committee of the European Parliament. 6. An Executive Director whose term of office has been extended shall not participate in another selection procedure for the same post at the end of the overall period. 7. The Executive Director may be removed from office only pursuant to a decision of the Council acting on a proposal from the Management Board. The European Parliament shall be informed about that decision. 8. The Management Board shall reach decisions regarding proposals to be made to the Council on the appointment, extension of the term of office, or removal from office, of the Executive Director by a majority of two-thirds of its members with voting rights. Article 55 Deputy Executive Directors 1. Three Deputy Executive Directors shall assist the Executive Director. The Executive Director shall define their tasks. 2. Article 54 shall apply to the Deputy Executive Directors. The Executive Director shall be consulted prior to their appointment, any extension of their term of office or their removal from office. Article 56 Seconded national experts 1. Europol may make use of seconded national experts. 2. The Management Board shall adopt a decision laying down rules on the secondment of national experts to Europol. CHAPTER X FINANCIAL PROVISIONS Article 57 Budget 1. Estimates of all revenue and expenditure for Europol shall be prepared each financial year, which shall correspond to the calendar year, and shall be shown in Europol's budget. 2. Europol's budget shall be balanced in terms of revenue and of expenditure. 3. Without prejudice to other resources, Europol's revenue shall comprise a contribution from the Union entered in the general budget of the Union. 4. Europol may benefit from Union funding in the form of delegation agreements or ad hoc grants in accordance with its financial rules referred to in Article 61 and with the provisions of the relevant instruments supporting the policies of the Union. 5. Europol's expenditure shall include staff remuneration, administrative and infrastructure expenses, and operating costs. 6. Budgetary commitments for actions relating to large-scale projects extending over more than one financial year may be broken down into several annual instalments. Article 58 Establishment of the budget 1. Each year the Executive Director shall draw up a draft statement of estimates of Europol's revenue and expenditure for the following financial year, including an establishment plan, and shall send it to the Management Board. 2. The Management Board shall, on the basis of the draft statement of estimates, adopt a provisional draft estimate of Europol's revenue and expenditure for the following financial year and shall send it to the Commission by 31 January each year. 3. The Management Board shall send the final draft estimate of Europol's revenue and expenditure, which shall include a draft establishment plan, to the European Parliament, the Council and the Commission by 31 March each year. 4. The Commission shall send the statement of estimates to the European Parliament and the Council, together with the draft general budget of the Union. 5. On the basis of the statement of estimates, the Commission shall enter in the draft general budget of the Union the estimates that it considers necessary for the establishment plan and the amount of the contribution to be charged to the general budget, which it shall place before the European Parliament and the Council in accordance with Articles 313 and 314 TFEU. 6. The European Parliament and the Council shall authorise the appropriations for the contribution from the Union to Europol. 7. The European Parliament and the Council shall adopt Europol's establishment plan. 8. Europol's budget shall be adopted by the Management Board. It shall become final following the final adoption of the general budget of the Union. Where necessary, it shall be adjusted accordingly. 9. For any building projects likely to have significant implications for Europol's budget, Delegated Regulation (EU) No 1271/2013 shall apply. Article 59 Implementation of the budget 1. The Executive Director shall implement Europol's budget. 2. Each year the Executive Director shall send to the European Parliament and the Council all information relevant to the findings of any evaluation procedures. Article 60 Presentation of accounts and discharge 1. Europol's accounting officer shall send the provisional accounts for the financial year (year N) to the Commission's accounting officer and to the Court of Auditors by 1 March of the following financial year (year N + 1). 2. Europol shall send a report on the budgetary and financial management for year N to the European Parliament, the Council and the Court of Auditors by 31 March of year N + 1. 3. The Commission's accounting officer shall send Europol's provisional accounts for year N, consolidated with the Commission's accounts, to the Court of Auditors by 31 March of year N + 1. 4. On receipt of the Court of Auditors' observations on Europol's provisional accounts for year N pursuant to Article 148 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (25), Europol's accounting officer shall draw up Europol's final accounts for that year. The Executive Director shall submit them to the Management Board for an opinion. 5. The Management Board shall deliver an opinion on Europol's final accounts for year N. 6. Europol's accounting officer shall, by 1 July of year N + 1, send the final accounts for year N to the European Parliament, the Council, the Commission, the Court of Auditors and national parliaments, together with the Management Board's opinion referred to in paragraph 5. 7. The final accounts for year N shall be published in the Official Journal of the European Union by 15 November of year N + 1. 8. The Executive Director shall send to the Court of Auditors, by 30 September of year N + 1, a reply to the observations made in its annual report. He or she shall also send the reply to the Management Board. 9. The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for year N, as laid down in Article 109(3) of Delegated Regulation (EU) No 1271/2013. 10. On a recommendation from the Council acting by a qualified majority, the European Parliament shall, before 15 May of year N + 2, grant a discharge to the Executive Director in respect of the implementation of the budget for year N. Article 61 Financial rules 1. The financial rules applicable to Europol shall be adopted by the Management Board after consultation with the Commission. They shall not depart from Delegated Regulation (EU) No 1271/2013 unless such a departure is specifically required for the operation of Europol and the Commission has given its prior consent. 2. Europol may award grants related to the fulfilment of tasks as referred to in Article 4. 3. Europol may award grants without a call for proposals to Member States for performance of their cross-border operations and investigations and for the provision of training relating to the tasks referred to in points (h) and (i) of Article 4(1). 4. In respect of the financial support to be given to joint investigation teams' activities, Europol and Eurojust shall jointly establish the rules and conditions upon which applications for such support are to be processed. CHAPTER XI MISCELLANEOUS PROVISIONS Article 62 Legal status 1. Europol shall be an agency of the Union. It shall have legal personality. 2. In each Member State Europol shall enjoy the most extensive legal capacity accorded to legal persons under national law. Europol may, in particular, acquire and dispose of movable and immovable property and be a party to legal proceedings. 3. In accordance with Protocol No 6 on the location of the seats of the institutions and of certain bodies, agencies and departments of the European Union, annexed to the TEU and to the TFEU (\u2018Protocol No 6\u2019), Europol shall have its seat in The Hague. Article 63 Privileges and immunities 1. Protocol No 7 on the privileges and immunities of the European Union, annexed to the TEU and to the TFEU, shall apply to Europol and its staff. 2. Privileges and immunities of liaison officers and members of their families shall be subject to an agreement between the Kingdom of Netherlands and the other Member States. That agreement shall provide for such privileges and immunities as are necessary for the proper performance of the tasks of liaison officers. Article 64 Language arrangements 1. The provisions laid down in Regulation No 1 (26) shall apply to Europol. 2. The Management Board shall decide by a majority of two-thirds of its members on the internal language arrangements of Europol. 3. The translation services required for the functioning of Europol shall be provided by the Translation Centre for the bodies of the European Union. Article 65 Transparency 1. Regulation (EC) No 1049/2001 shall apply to documents held by Europol. 2. By 14 December 2016, the Management Board shall adopt the detailed rules for applying Regulation (EC) No 1049/2001 with regard to Europol documents. 3. Decisions taken by Europol under Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the European Ombudsman or of an action before the Court of Justice of the European Union, in accordance with Articles 228 and 263 TFEU respectively. 4. Europol shall publish on its website a list of the Management Board members and summaries of the outcome of the meetings of the Management Board. The publication of those summaries shall be temporarily or permanently omitted or restricted if such publication would risk jeopardising the performance of Europol's tasks, taking into account its obligations of discretion and confidentiality and the operational character of Europol. Article 66 Combating fraud 1. In order to facilitate the fight against fraud, corruption and any other illegal activities under Regulation (EU, Euratom) No 883/2013, Europol shall, by 30 October 2017, accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (27) and shall adopt appropriate provisions applicable to all employees of Europol, using the template set out in the Annex to that Agreement. 2. The Court of Auditors shall have a power of audit, on the basis of documents and on-the-spot checks, over all grant beneficiaries, contractors and subcontractors who have received Union funds from Europol. 3. OLAF may carry out investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant or a contract awarded by Europol. Such investigations shall be carried out in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and in Council Regulation (Euratom, EC) No 2185/96 (28). 4. Without prejudice to paragraphs 1, 2 and 3, working arrangements with Union bodies, authorities of third countries, international organisations and private parties, contracts, grant agreements and grant decisions of Europol shall contain provisions expressly empowering the Court of Auditors and OLAF to conduct the audits and investigations referred to in paragraphs 2 and 3, in accordance with their respective competences. Article 67 Rules on the protection of sensitive non-classified and classified information 1. Europol shall establish rules on the obligations of discretion and confidentiality and on the protection of sensitive non-classified information. 2. Europol shall establish rules on the protection of EU classified information which shall be consistent with Decision 2013/488/EU in order to ensure an equivalent level of protection for such information. Article 68 Evaluation and review 1. By 1 May 2022 and every five years thereafter, the Commission shall ensure that an evaluation assessing, in particular, the impact, effectiveness and efficiency of Europol and of its working practices is carried out. The evaluation may, in particular, address the possible need to modify the structure, operation, field of action and tasks of Europol, and the financial implications of any such modification. 2. The Commission shall submit the evaluation report to the Management Board. The Management Board shall provide its observations on the evaluation report within three months from the date of receipt. The Commission shall then submit the final evaluation report, together with the Commission's conclusions, and the Management Board's observations in an annex thereto, to the European Parliament, the Council, the national parliaments and the Management Board. Where appropriate, the main findings of the evaluation report shall be made public. Article 69 Administrative inquiries The activities of Europol shall be subject to inquiries by the European Ombudsman in accordance with Article 228 TFEU. Article 70 Headquarters The necessary arrangements concerning the accommodation to be provided for Europol in the Kingdom of the Netherlands and the facilities to be made available by the Kingdom of the Netherlands, together with the specific rules applicable there to the Executive Director, members of the Management Board, Europol's staff and members of their families, shall be laid down in a headquarters agreement between Europol and the Kingdom of the Netherlands, in accordance with Protocol No 6. CHAPTER XII TRANSITIONAL PROVISIONS Article 71 Legal succession 1. Europol as established by this Regulation shall be the legal successor in respect of all contracts concluded by, liabilities incumbent upon and properties acquired by Europol as established by Decision 2009/371/JHA. 2. This Regulation shall not affect the legal force of agreements concluded by Europol as established by Decision 2009/371/JHA before 13 June 2016, or of agreements concluded by Europol as established by the Europol Convention before 1 January 2010. Article 72 Transitional arrangements concerning the Management Board 1. The term of office of the members of the Management Board as established on the basis of Article 37 of Decision 2009/371/JHA shall terminate on 1 May 2017. 2. During the period from 13 June 2016 to 1 May 2017, the Management Board as established on the basis of Article 37 of Decision 2009/371/JHA shall: (a) exercise the functions of the Management Board in accordance with Article 11 of this Regulation; (b) prepare the adoption of the rules relating to the application of Regulation (EC) No 1049/2001 with regard to Europol documents as referred to in Article 65(2) of this Regulation, and of the rules referred to in Article 67 of this Regulation; (c) prepare any instrument necessary for the application of this Regulation, in particular any measures relating to Chapter IV; and (d) review the internal rules and measures which it has adopted on the basis of Decision 2009/371/JHA so as to allow the Management Board as established pursuant to Article 10 of this Regulation to take a decision pursuant to Article 76 of this Regulation. 3. The Commission shall without delay after 13 June 2016 take the measures necessary to ensure that the Management Board established pursuant to Article 10 starts its work on 1 May 2017. 4. By 14 December 2016, the Member States shall notify the Commission of the names of the persons whom they have appointed as member and alternate member of the Management Board, in accordance with Article 10. 5. The Management Board established pursuant to Article 10 shall hold its first meeting on 1 May 2017. On that occasion it shall, if necessary, take decisions as referred to in Article 76. Article 73 Transitional arrangements concerning the Executive Director, the Deputy Directors and staff 1. The Director of Europol appointed on the basis of Article 38 of Decision 2009/371/JHA shall, for the remaining period of his or her term of office, be assigned the responsibilities of Executive Director, as provided for in Article 16 of this Regulation. The other conditions of his or her contract shall remain unchanged. If the term of office ends between 13 June 2016 and 1 May 2017, it shall be extended automatically until 1 May 2018. 2. Should the Director appointed on the basis of Article 38 of Decision 2009/371/JHA be unwilling or unable to act in accordance with paragraph 1 of this Article, the Management Board shall designate an interim Executive Director to exercise the duties assigned to the Executive Director for a period not exceeding 18 months, pending the appointment provided for in Article 54(2) of this Regulation. 3. Paragraphs 1 and 2 of this Article shall apply to the Deputy Directors appointed on the basis of Article 38 of Decision 2009/371/JHA. 4. In accordance with the Conditions of Employment of Other Servants, the authority referred to in the first paragraph of Article 6 thereof shall offer employment of indefinite duration as a member of the temporary or contract staff to any person who, on 1 May 2017, is employed under a contract of indefinite duration as a local staff member concluded by Europol as established by the Europol Convention. The offer of employment shall be based on the tasks to be performed by the servant as a member of the temporary or contract staff. The contract concerned shall take effect at the latest on 1 May 2018. A staff member who does not accept the offer referred to in this paragraph may retain his or her contractual relationship with Europol in accordance with Article 53(1). Article 74 Transitional budgetary provisions The discharge procedure in respect of the budgets approved on the basis of Article 42 of Decision 2009/371/JHA shall be carried out in accordance with the rules established by Article 43 thereof. CHAPTER XIII FINAL PROVISIONS Article 75 Replacement and repeal 1. Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA are hereby replaced for the Member States bound by this Regulation with effect from 1 May 2017. Therefore, Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA are repealed with effect from 1 May 2017. 2. With regard to the Member States bound by this Regulation, references to the Decisions referred to in paragraph 1 shall be construed as references to this Regulation. Article 76 Maintenance in force of the internal rules adopted by the Management Board Internal rules and measures adopted by the Management Board on the basis of Decision 2009/371/JHA shall remain in force after 1 May 2017, unless otherwise decided by the Management Board in the application of this Regulation. Article 77 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 1 May 2017. However, Articles 71, 72 and 73 shall apply from 13 June 2016. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 11 May 2016. For the European Parliament The President M. SCHULZ For the Council The President J.A. HENNIS-PLASSCHAERT (1) Position of the European Parliament of 25 February 2014 (not yet published in the Official Journal) and position of the Council at first reading of 10 March 2016 (not yet published in the Official Journal). Position of the European Parliament of 11 May 2016 (not yet published in the Official Journal). (2) Council Decision 2009/371/JHA of 6 April 2009 establishing the European Police Office (Europol) (OJ L 121, 15.5.2009, p. 37). (3) OJ C 316, 27.11.1995, p. 1. (4) OJ C 115, 4.5.2010, p. 1. (5) Council Decision 2009/934/JHA of 30 November 2009 adopting the implementing rules governing Europol's relations with partners, including the exchange of personal data and classified information (OJ L 325, 11.12.2009, p. 6). (6) Council Decision 2009/935/JHA of 30 November 2009 determining the list of third States and organisations with which Europol shall conclude agreements (OJ L 325, 11.12.2009, p. 12). (7) Council Decision 2009/936/JHA of 30 November 2009 adopting the implementing rules for Europol analysis work files (OJ L 325, 11.12.2009, p. 14). (8) Council Decision 2009/968/JHA of 30 November 2009 adopting the rules on the confidentiality of Europol information (OJ L 332, 17.12.2009, p. 17). (9) Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, p. 27). (10) Regulation (Euratom, ECSC, EEC) No 549/69 of the Council of 25 March 1969 determining the categories of officials and other servants of the European Communities to whom the provisions of Article 12, the second paragraph of Article 13 and Article 14 of the Protocol on the Privileges and Immunities of the Communities apply (OJ L 74, 27.3.1969, p. 1). (11) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (12) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (13) Council of Europe Committee of Ministers Recommendation No R(87) 15 to the Member States on regulating the use of personal data in the police sector, 17.9.1987. (14) OJ L 56, 4.3.1968, p. 1. (15) Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (OJ L 328, 7.12.2013, p. 42). (16) Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union (OJ L 362, 31.12.2012, p. 1). (17) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (18) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). (19) Council Act of 3 December 1998 laying down the staff regulations applicable to Europol employees (OJ C 26, 30.1.1999, p. 23). (20) Council Decision 2005/511/JHA of 12 July 2005 on protecting the euro against counterfeiting, by designating Europol as the Central Office for combating euro counterfeiting (OJ L 185, 16.7.2005, p. 35). (21) Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (OJ L 309, 25.11.2005, p. 15). (22) Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (OJ L 190, 18.7.2002, p. 1). (23) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (24) OJ C 95, 1.4.2014, p. 1. (25) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (26) Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385/58). (27) OJ L 136, 31.5.1999, p. 15. (28) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). ANNEX I LIST OF FORMS OF CRIME REFERRED TO IN ARTICLE 3(1) \u2014 terrorism, \u2014 organised crime, \u2014 drug trafficking, \u2014 money-laundering activities, \u2014 crime connected with nuclear and radioactive substances, \u2014 immigrant smuggling, \u2014 trafficking in human beings, \u2014 motor vehicle crime, \u2014 murder and grievous bodily injury, \u2014 illicit trade in human organs and tissue, \u2014 kidnapping, illegal restraint and hostage-taking, \u2014 racism and xenophobia, \u2014 robbery and aggravated theft, \u2014 illicit trafficking in cultural goods, including antiquities and works of art, \u2014 swindling and fraud, \u2014 crime against the financial interests of the Union, \u2014 insider dealing and financial market manipulation, \u2014 racketeering and extortion, \u2014 counterfeiting and product piracy, \u2014 forgery of administrative documents and trafficking therein, \u2014 forgery of money and means of payment, \u2014 computer crime, \u2014 corruption, \u2014 illicit trafficking in arms, ammunition and explosives, \u2014 illicit trafficking in endangered animal species, \u2014 illicit trafficking in endangered plant species and varieties, \u2014 environmental crime, including ship-source pollution, \u2014 illicit trafficking in hormonal substances and other growth promoters, \u2014 sexual abuse and sexual exploitation, including child abuse material and solicitation of children for sexual purposes, \u2014 genocide, crimes against humanity and war crimes. ANNEX II A. Categories of personal data and categories of data subjects whose data may be collected and processed for the purpose of cross-checking as referred to in point (a) of Article 18(2) 1. Personal data collected and processed for the purpose of cross-checking shall relate to: (a) persons who, in accordance with the national law of the Member State concerned, are suspected of having committed or having taken part in a criminal offence in respect of which Europol is competent, or who have been convicted of such an offence; (b) persons regarding whom there are factual indications or reasonable grounds under the national law of the Member State concerned to believe that they will commit criminal offences in respect of which Europol is competent. 2. Data relating to the persons referred to in paragraph 1 may include only the following categories of personal data: (a) surname, maiden name, given names and any alias or assumed name; (b) date and place of birth; (c) nationality; (d) sex; (e) place of residence, profession and whereabouts of the person concerned; (f) social security numbers, driving licences, identification documents and passport data; and (g) where necessary, other characteristics likely to assist in identification, including any specific objective physical characteristics not subject to change such as dactyloscopic data and DNA profile (established from the non-coding part of DNA). 3. In addition to the data referred to in paragraph 2, the following categories of personal data concerning the persons referred to in paragraph 1 may be collected and processed: (a) criminal offences, alleged criminal offences and when, where and how they were (allegedly) committed; (b) means which were or which may have been used to commit those criminal offences, including information concerning legal persons; (c) departments handling the case and their filing references; (d) suspected membership of a criminal organisation; (e) convictions, where they relate to criminal offences in respect of which Europol is competent; (f) inputting party. These data may be provided to Europol even when they do not yet contain any references to persons. 4. Additional information held by Europol or national units concerning the persons referred to in paragraph 1 may be communicated to any national unit or to Europol, should either so request. National units shall do so in compliance with their national law. 5. If proceedings against the person concerned are definitively dropped or if that person is definitively acquitted, the data relating to the case in respect of which either decision has been taken shall be deleted. B. Categories of personal data and categories of data subjects whose data may be collected and processed for the purpose of analyses of a strategic or thematic nature, for the purpose of operational analyses or for the purpose of facilitating the exchange of information as referred to in points (b), (c) and (d) of Article 18(2) 1. Personal data collected and processed for the purpose of analyses of a strategic or thematic nature, for the purpose of operational analyses or for the purpose of facilitating the exchange of information between Member States, Europol, other Union bodies, third countries and international organisations shall relate to: (a) persons who, pursuant to the national law of the Member State concerned, are suspected of having committed or having taken part in a criminal offence in respect of which Europol is competent, or who have been convicted of such an offence; (b) persons regarding whom there are factual indications or reasonable grounds under the national law of the Member State concerned to believe that they will commit criminal offences in respect of which Europol is competent; (c) persons who might be called on to testify in investigations in connection with the offences under consideration or in subsequent criminal proceedings; (d) persons who have been the victims of one of the offences under consideration or with regard to whom certain facts give reason to believe that they could be the victims of such an offence; (e) contacts and associates; and (f) persons who can provide information on the criminal offences under consideration. 2. The following categories of personal data, including associated administrative data, may be processed on the categories of persons referred to in points (a) and (b) of paragraph 1: (a) personal details: (i) present and former surnames; (ii) present and former forenames; (iii) maiden name; (iv) father's name (where necessary for the purpose of identification); (v) mother's name (where necessary for the purpose of identification): (vi) sex; (vii) date of birth; (viii) place of birth; (ix) nationality; (x) marital status; (xi) alias; (xii) nickname; (xiii) assumed or false name; (xiv) present and former residence and/or domicile; (b) physical description: (i) physical description; (ii) distinguishing features (marks/scars/tattoos etc.); (c) means of identification: (i) identity documents/driving licence; (ii) national identity card/passport numbers; (iii) national identification number/social security number, if applicable; (iv) visual images and other information on appearance; (v) forensic identification information such as fingerprints, DNA profile (established from the non-coding part of DNA), voice profile, blood group, dental information; (d) occupation and skills: (i) present employment and occupation; (ii) former employment and occupation; (iii) education (school/university/professional); (iv) qualifications; (v) skills and other fields of knowledge (language/other); (e) economic and financial information: (i) financial data (bank accounts and codes, credit cards, etc.); (ii) cash assets; (iii) shareholdings/other assets; (iv) property data; (v) links with companies; (vi) bank and credit contacts; (vii) tax position; (viii) other information revealing a person's management of his or her financial affairs; (f) behavioural data: (i) lifestyle (such as living above means) and routine; (ii) movements; (iii) places frequented; (iv) weapons and other dangerous instruments; (v) danger rating; (vi) specific risks such as escape probability, use of double agents, connections with law enforcement personnel; (vii) criminal-related traits and profiles; (viii) drug abuse; (g) contacts and associates, including type and nature of the contact or association; (h) means of communication used, such as telephone (static/mobile), fax, pager, electronic mail, postal addresses, internet connection(s); (i) means of transport used, such as vehicles, boats, aircraft, including information identifying those means of transport (registration numbers); (j) information relating to criminal conduct: (i) previous convictions; (ii) suspected involvement in criminal activities; (iii) modi operandi; (iv) means which were or may be used to prepare and/or commit crimes; (v) membership of criminal groups/organisations and position in the group/organisation; (vi) role in the criminal organisation; (vii) geographical range of criminal activities; (viii) material gathered in the course of an investigation, such as video and photographic images; (k) references to other information systems in which information on the person is stored: (i) Europol; (ii) police/customs agencies; (iii) other enforcement agencies; (iv) international organisations; (v) public entities; (vi) private entities; (l) information on legal persons associated with the data referred to in points (e) and (j): (i) designation of the legal person; (ii) location; (iii) date and place of establishment; (iv) administrative registration number; (v) legal form; (vi) capital; (vii) area of activity; (viii) national and international subsidiaries; (ix) directors; (x) links with banks. 3. \u2018Contacts and associates\u2019, as referred to in point (e) of paragraph 1, are persons through whom there is sufficient reason to believe that information which relates to the persons referred to in points (a) and (b) of paragraph 1 and which is relevant for the analysis can be gained, provided they are not included in one of the categories of persons referred to in points (a), (b), (c), (d) and (f) of paragraph 1. \u2018Contacts\u2019 are those persons who have a sporadic contact with the persons referred to in points (a) and (b) of paragraph 1. \u2018Associates\u2019 are those persons who have a regular contact with the persons referred to in points (a) and (b) of paragraph 1. In relation to contacts and associates, the data referred to in paragraph 2 may be stored as necessary, provided there is reason to assume that such data are required for the analysis of the relationship of such persons with persons referred to in points (a) and (b) of paragraph 1. In this context, the following shall be observed: (a) such relationship shall be clarified as soon as possible; (b) the data referred to in paragraph 2 shall be deleted without delay if the assumption that such relationship exists turns out to be unfounded; (c) all data referred to in paragraph 2 may be stored if contacts or associates are suspected of having committed an offence falling within the scope of Europol's objectives, or have been convicted for the commission of such an offence, or if there are factual indications or reasonable grounds under the national law of the Member State concerned to believe that they will commit such an offence; (d) data referred to in paragraph 2 on contacts, and associates, of contacts as well as on contacts, and associates, of associates shall not be stored, with the exception of data on the type and nature of their contact or association with the persons referred to in points (a) and (b) of paragraph 1; (e) if a clarification pursuant to the previous points is not possible, this shall be taken into account when a decision is taken on the need for, and the extent of, data storage for further analysis. 4. With regard to a person who, as referred to in point (d) of paragraph 1, has been the victim of one of the offences under consideration or who, on the basis of certain facts there is reason to believe could be the victim of such an offence, the data referred to in point (a) to point (c)(iii) of paragraph 2 as well as the following categories of data may be stored: (a) victim identification data; (b) reason for victimisation; (c) damage (physical/financial/psychological/other); (d) whether anonymity is to be guaranteed; (e) whether participation in a court hearing is possible; (f) crime-related information provided by or through persons referred to in point (d) of paragraph 1, including where necessary information on their relationship with other persons, for the purpose of identifying the persons referred to in points (a) and (b) of paragraph 1. Other data referred to in paragraph 2 may be stored as necessary, provided there is reason to assume that they are required for the analysis of a person's role as victim or potential victim. Data not required for any further analysis shall be deleted. 5. With regard to persons who, as referred to in point (c) of paragraph 1, might be called on to testify in investigations in connection with the offences under consideration or in subsequent criminal proceedings, data referred to in point (a) to point (c)(iii) of paragraph 2 as well as categories of data complying with the following criteria may be stored: (a) crime-related information provided by such persons, including information on their relationship with other persons included in the analysis work file; (b) whether anonymity is to be guaranteed; (c) whether protection is to be guaranteed and by whom; (d) new identity; (e) whether participation in a court hearing is possible. Other data referred to in paragraph 2 may be stored as necessary, provided there is reason to assume that they are required for the analysis of such persons' role as witness. Data not required for any further analysis shall be deleted. 6. With regard to persons who, as referred to in point (f) of paragraph 1, can provide information on the criminal offences under consideration, data referred to in point (a) to point (c)(iii) of paragraph 2 as well as categories of data complying with the following criteria may be stored: (a) coded personal details; (b) type of information supplied; (c) whether anonymity is to be guaranteed; (d) whether protection is to be guaranteed and by whom; (e) new identity; (f) whether participation in a court hearing is possible; (g) negative experiences; (h) rewards (financial/favours). Other data referred to in paragraph 2 may be stored as necessary, provided there is reason to assume that they are required for the analysis of such persons' role as informant. Data not required for any further analysis shall be deleted. 7. If, at any time during the course of an analysis, it becomes clear on the basis of serious and corroborating indications that a person should be included in a category of persons, as defined in this Annex, other than the category in which that person was initially placed, Europol may process only the data on that person which is permitted under that new category, and all other data shall be deleted. If, on the basis of such indications, it becomes clear that a person should be included in two or more different categories as defined in this Annex, all data allowed under such categories may be processed by Europol.", "summary": "European Union Agency for Law Enforcement Cooperation (Europol) European Union Agency for Law Enforcement Cooperation (Europol) SUMMARY OF: Regulation (EU) 2016/794 on the European Union Agency for Law Enforcement Cooperation (Europol) WHAT IS THE AIM OF THE REGULATION? It sets up the rules for Europol, including a system by which the European Parliament, together with national parliaments, can politically monitor Europol\u2019s activities. In addition, it adapts Europol\u2019s external relations to the rules of the Lisbon Treaty. The regulation aligns the current Council decision on Europol with the rules of the Lisbon Treaty. KEY POINTS Objectives Europol\u2019s objectives are to support and strengthen: action by authorities in the European Union (EU) countries; mutual cooperation amongst EU countries in preventing and combating terrorism, serious crime affecting two or more EU countries and forms of crime which affect a common interest covered by EU policy. Tasks The regulation sets out a number of specific tasks in order to meet those objectives including: collecting, storing, processing, analysing and exchanging information including criminal intelligence; notifying EU countries, via Europol national units, without delay, of any information and connection between criminal offences concerning them; coordinating, organising and implementing investigative and operational actions to support and strengthen actions by EU countries\u2019 authorities; preparing threat assessments, strategic and operational analyses and general situation reports; participating in joint investigation teams; developing EU centres of specialised expertise for combating certain types of crime, for example the European Cybercrime Centre; supporting EU countries in combating crime enabled, promoted or committed using the internet. Scrutiny Europol\u2019s powers are accompanied by data protection safeguards and parliamentary scrutiny: The European Data Protection Supervisor monitors Europol\u2019s processing of personal data and there will be a clear procedure for citizens to address requests under EU law. Europol\u2019s work is overseen by a Joint Parliamentary Scrutiny Group, with members from both national parliaments and the European Parliament. FROM WHEN DOES THE REGULATION APPLY? It applies from 1 May 2017 except for Articles 71 (legal agreements and contracts concluded under Decision 2009/371), 72 (transitional arrangements concerning the management board) and 73 (transitional arrangements concerning staff) which apply from 13 June 2016. BACKGROUND For more information, see: \u2018About Europol\u2019 on Europol's website. Communication from the Commission COVID-19 Guidance on the implementation of the temporary restriction on non-essential travel to the EU, on the facilitation of transit arrangements for the repatriation of EU citizens, and on the effects on visa policy MAIN DOCUMENT Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, pp. 53-114) RELATED DOCUMENTS Council Framework Decision 2002/465/JHA of 13 June 2002 on joint investigation teams (OJ L 162, 20.6.2002, pp. 1-3) Council Decision 2009/371/JHA of 6 April 2009 establishing the European Police Office (Europol) (OJ L 121, 15.5.2009, pp. 37-66) last update 04.05.2020"}
{"article": "20.5.2020 EN Official Journal of the European Union L 159/1 COUNCIL REGULATION (EU) 2020/672 of 19 May 2020 on the establishment of a European instrument for temporary support to mitigate unemployment risks in an emergency (SURE) following the COVID-19 outbreak THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 122 thereof, Having regard to the proposal from the European Commission, Whereas: (1) Article 122(1) of the Treaty on the Functioning of the European Union (TFEU) allows the Council to decide, on a proposal from the Commission and in a spirit of solidarity between Member States, upon the measures appropriate to respond to the socio\u2010economic situation following the COVID-19 outbreak. (2) Article 122(2) TFEU enables the Council to grant Union financial assistance to a Member State that is in difficulties or is seriously threatened with severe difficulties caused by exceptional occurrences beyond its control. (3) The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), which causes the coronavirus disease named COVID-19 by the World Health Organization (WHO), is a new strain of coronavirus not previously identified in humans. The global outbreak of that disease is evolving rapidly and has been declared a pandemic by the WHO. From the beginning of the COVID-19 outbreak in the Union up until 30 March 2020, 334 396 cases and 22 209 deaths were reported in the Member States. (4) Member States have implemented extraordinary measures to contain the COVID\u201019 outbreak and its impact. The probability of further transmission of COVID\u201019 in the Union is considered high. In addition to public health impacts with substantial fatal outcomes, the COVID\u201019 outbreak has had a massive and disruptive impact on the economic systems of the Member States, caused societal disruptions and increased public expenditure in a growing number of Member States. (5) That exceptional situation, which is beyond the control of the Member States and which has immobilised a substantial part of their labour force, has led to a sudden and severe increase in public expenditure by the Member States on short-time work schemes for employees and similar measures, in particular for the self-employed, as well as expenditure on some health-related measures, in particular in the workplace. In order to maintain the strong focus of the instrument provided for in this Regulation and thereby its effectiveness, health-related measures for the purpose of that instrument may consist of those aiming at reducing occupational hazards and ensuring the protection of workers and the self\u2010employed in the workplace, and, where appropriate, some other health\u2010related measures. It is necessary to facilitate efforts by the Member States to address the sudden and severe increase in public expenditure until the COVID-19 outbreak and its impact on their labour force are under control. (6) The creation of a European instrument for temporary support to mitigate unemployment risks in an emergency (SURE) (the \u2018Instrument\u2019) following the COVID-19 outbreak should enable the Union to respond to the crisis in the labour market in a coordinated, rapid and effective manner and in a spirit of solidarity among Member States, thereby alleviating the impact on employment for individuals and the most affected economic sectors and mitigating the direct effects of this exceptional situation on public expenditure by the Member States. (7) Article 220(1) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (1) states that financial assistance by the Union to Member States can take the form of a loan. Such loans should be granted to Member States where the COVID-19 outbreak has led to a sudden and severe increase, as from 1 February 2020, in actual and possibly also planned public expenditure due to national measures. That date ensures equal treatment for all Member States and allows for coverage of their actual and possibly also planned increases in spending relating to the effects on the labour markets of the Member States, irrespective of when the COVID-19 outbreak occurred in each specific Member State. The national measures, which are understood to be in line with the relevant fundamental rights principles, should be directly related to the creation or extension of short-time work schemes and to similar measures, including measures for self-employed persons, or to some health-related measures. Short-time work schemes are public programmes that in certain circumstances allow businesses experiencing economic difficulties to temporarily reduce the hours worked by their employees, who are provided with public income support for the hours not worked. Similar schemes exist for income replacement for the self-employed. The Member State requesting financial assistance should provide evidence of a sudden and severe increase in actual and possibly also planned public expenditure for short-time work schemes or similar measures. If financial assistance is granted for health-related measures, the Member State requesting financial assistance should also provide evidence of actual or planned expenditure related to the relevant health-related measures. (8) In order to provide the affected Member States with sufficient financial means under favourable terms to enable them to deal with the impact of the COVID-19 outbreak on their labour market, the Union\u2019s borrowing and lending operations under the Instrument should be sufficiently large. The financial assistance granted by the Union in the form of loans should therefore be financed by recourse to international capital markets. (9) The COVID-19 outbreak has had a massive and disruptive impact on the economic system of each Member State. It therefore calls for collective contributions by Member States in the form of guarantees supporting the loans from the Union budget. Such guarantees are necessary to enable the Union to grant loans of a sufficient order of magnitude to Member States in order to support labour market policies which are under the greatest strain. To ensure that the contingent liability arising from such loans is compatible with the applicable multiannual financial framework (\u2018MFF\u2019) and own\u2010resources ceilings, the guarantees provided by the Member States should be irrevocable, unconditional and on demand, while additional safeguards should enhance the robustness of the system. In line with the complementary role of such guarantees, and without prejudice to their irrevocable, unconditional and on-demand nature, the Commission is expected, before calling on the guarantees provided by Member States, to draw on the margin available under the own\u2010resources ceiling for payment appropriations to the extent that it is deemed sustainable by the Commission, having regard, inter alia, to the total contingent liabilities of the Union, including under the balance of payments facility established by Council Regulation (EC) No 332/2002 (2). In the relevant call on guarantees, the Commission should inform the Member States about the extent to which the available margin has been drawn. The need for guarantees provided by Member States may be reviewed if an agreement on a revised own-resources ceiling is reached. (10) The additional safeguards to enhance the robustness of the system should consist of conservative financial management, a maximum annual exposure and sufficient diversification of the loan portfolio. (11) The loans granted under the Instrument should constitute financial assistance within the meaning of Article 220 of Regulation (EU, Euratom) 2018/1046. In accordance with point (g) of Article 282(3) of that Regulation, Article 220 of that Regulation will apply to the loans granted under the Instrument only as from the date of application of the post\u20102020 MFF. However, it is appropriate that the requirements set out in Article 220(5) of Regulation (EU, Euratom) 2018/1046 apply to the borrowing and lending operations under the Instrument as of the entry into force of this Regulation. (12) In order to make the contingent liability arising from loans granted under the Instrument compatible with the applicable MFF and own-resources ceilings, it is necessary to lay down prudential rules, including on the possibility of rolling over the borrowings contracted on behalf of the Union. (13) Given their particular financial implications, decisions to grant financial assistance pursuant to this Regulation require the exercise of implementing powers, which should be conferred on the Council. When deciding upon the amount of a loan, the Council, on a proposal from the Commission, should consider the existing and expected needs of the requesting Member State, as well as requests for financial assistance pursuant to this Regulation already submitted or planned to be submitted by other Member States, having regard to the principles of equal treatment, solidarity, proportionality and transparency, and in a manner that fully respects the competence of the Member States. (14) Article 143(1) of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (3) (the \u2018Withdrawal Agreement\u2019) limits the liability of the United Kingdom for its share of the contingent financial liabilities of the Union to those contingent financial liabilities of the Union arising from financial operations taken by the Union before the date of entry into force of the Withdrawal Agreement. Any contingent financial liability of the Union arising from financial assistance under this Regulation would be subsequent to the date of entry into force of the Withdrawal Agreement. Therefore, the United Kingdom should not participate in the financial assistance under this Regulation. (15) As the Instrument is of a temporary nature in order to address the COVID\u201019 outbreak, the Commission should assess every six months whether the exceptional circumstances causing the severe economic disturbances in Member States still exist and report to the Council. Consistently with the legal basis for the adoption of this Regulation, no financial assistance should be made available under this Regulation once the COVID\u201019 emergency has passed. To that end, it is appropriate to limit the availability of the Instrument in time. The Council should be empowered, on a proposal from the Commission, to extend the period of availability of the Instrument where the exceptional occurrences that justify the application of this Regulation continue to exist. (16) The European Central Bank delivered its opinion on 8 May 2020. (17) Given the impact of the COVID-19 outbreak and the need for an urgent response to the consequences of that outbreak, this Regulation should enter into force on the date of its publication in the Official Journal of the European Union, HAS ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. In order to address the impact of the COVID-19 outbreak and respond to its socio\u2010economic consequences, this Regulation establishes the European instrument for temporary support to mitigate unemployment risks in an emergency (SURE) (the \u2018Instrument\u2019). 2. This Regulation lays down the conditions and procedures enabling the Union to provide financial assistance to a Member State which is experiencing, or is seriously threatened with, a severe economic disturbance caused by the COVID-19 outbreak for the financing, primarily, of short-time work schemes or similar measures aimed at protecting employees and the self\u2010employed and thus reducing the incidence of unemployment and loss of income, as well as for the financing, as an ancillary, of some health-related measures, in particular in the workplace. Article 2 Complementary nature of the Instrument The Instrument shall complement the national measures taken by affected Member States by providing financial assistance to help those Member States cope with the sudden and severe increase in actual and possibly also planned public expenditure intended to mitigate the direct economic, social and health-related effects of the exceptional occurrence caused by the COVID\u201019 outbreak. Article 3 Conditions for using the Instrument 1. A Member State may request Union financial assistance under the Instrument (\u2018financial assistance\u2019) where its actual and possibly also planned public expenditure has suddenly and severely increased as of 1 February 2020 due to national measures directly related to short\u2010time work schemes and similar measures to address the socio-economic effects of the exceptional occurrence caused by the COVID-19 outbreak. 2. Beneficiary Member States shall use financial assistance primarily in support of their national short-time work schemes or similar measures, and, where applicable, in support of relevant health-related measures. Article 4 Form of financial assistance The financial assistance shall take the form of a loan granted by the Union to the Member State concerned. To that end, and in accordance with a Council implementing decision adopted pursuant to Article 6(1), the Commission shall be empowered to borrow on the capital markets or with financial institutions on behalf of the Union at the most appropriate time so as to optimise the cost of funding and preserve its reputation as the Union\u2019s issuer in the markets. Article 5 Maximum amount of financial assistance The maximum amount of financial assistance shall not exceed EUR 100 000 000 000 for all Member States. Article 6 Procedure for requesting financial assistance 1. Financial assistance shall be made available by means of a Council implementing decision adopted on the basis of a proposal from the Commission. 2. Before submitting a proposal to the Council, the Commission shall consult the Member State concerned without undue delay to verify the sudden and severe increase in actual and possibly also planned public expenditure directly related to short-time work schemes and similar measures, as well as, where appropriate, to relevant health-related measures, in the Member State requesting financial assistance which are linked to the exceptional occurrence caused by the COVID-19 outbreak. To that end, the Member State concerned shall provide the Commission with appropriate evidence. In addition, the Commission shall verify compliance with the prudential rules laid down in Article 9. 3. The Council implementing decision referred to in paragraph 1 shall contain: (a) the amount of the loan, its maximum average maturity, its pricing formula, its maximum number of instalments, its availability period and the other detailed rules needed for the granting of the financial assistance; (b) an assessment of the compliance by the Member State with the conditions set out in Article 3; and (c) a description of the national short-time work schemes or similar measures, as well as, where appropriate, of the relevant health-related measures, that may be financed. 4. When adopting an implementing decision as referred to in paragraph 1, the Council shall consider existing and expected needs of the requesting Member State, as well as requests for financial assistance pursuant to this Regulation already submitted or planned to be submitted by other Member States, while applying the principles of equal treatment, solidarity, proportionality and transparency. Article 7 Disbursement of the loan granted under the Instrument The loan granted under the Instrument (\u2018loan\u2019) shall be disbursed in instalments. Article 8 Borrowing and lending operations 1. The borrowing and lending operations under the Instrument shall be carried out in euros. 2. The characteristics of the loan shall be agreed in a loan agreement between the beneficiary Member State and the Commission (the \u2018loan agreement\u2019). Such agreements shall contain the provisions set out in Article 220(5) of Regulation (EU, Euratom) 2018/1046. 3. At the request of the beneficiary Member State and where circumstances permit an improvement in the interest rate on the loan, the Commission may refinance all or part of its initial borrowing or restructure the corresponding financial conditions. 4. The Economic and Financial Committee shall be kept informed of a refinancing or restructuring as referred to in paragraph 3. Article 9 Prudential rules applicable to the portfolio of loans 1. The share of loans granted to the three Member States representing the largest share of the loans granted shall not exceed 60 per cent of the maximum amount referred to in Article 5. 2. The amounts due by the Union in a given year shall not exceed 10 per cent of the maximum amount referred to in Article 5. 3. Where necessary, the Commission may roll over the associated borrowings contracted on behalf of the Union. Article 10 Administration of the loans 1. The Commission shall establish the necessary arrangements for the administration of the loans with the European Central Bank. 2. The beneficiary Member State shall open a special account with its national central bank for the management of the financial assistance received. It shall also transfer the principal and the interest due under the loan agreement to an account with the European System of Central Banks 20 TARGET2 business days prior to the corresponding due date. Article 11 Contributions to the Instrument in the form of guarantees from Member States 1. Member States may contribute to the Instrument by counter-guaranteeing the risk borne by the Union. 2. Contributions from Member States shall be provided in the form of irrevocable, unconditional and on-demand guarantees. 3. The Commission shall conclude an agreement with a contributing Member State on the irrevocable, unconditional and on-demand guarantees referred to in paragraph 2. Such agreements shall set out the payment conditions. 4. Calls on guarantees provided by Member States shall be made pro rata to the relative share of each Member State in the gross national income of the Union as referred to in Article 12(1). Where a Member State fails, in full or in part, to honour a call in time, the Commission, in order to cover for the part corresponding to the Member State concerned, shall have the right to make additional calls on guarantees to other Member States. Such calls shall be made pro rata to the relative share of each of the other Member States in the gross national income of the Union as referred to in Article 12(1) and adapted without taking into account the relative share of the Member State concerned. The Member State which failed to honour the call shall remain liable to honour it. The other Member States shall be reimbursed for additional contributions from the amounts recovered by the Commission from the Member State concerned. The guarantee called from a Member State shall be limited, in all circumstances, by the overall amount of guarantee contributed by that Member State under the agreement referred to in paragraph 3. 5. Before calling on guarantees provided by the Member States, the Commission, at its sole discretion and responsibility as the Union institution entrusted with the implementation of the general budget of the Union in accordance with Article 317 TFEU, is expected to examine the scope for drawing on the margin available under the own-resources ceiling for payment appropriations to the extent that it is deemed sustainable by the Commission, having regard, inter alia, to the total contingent liabilities of the Union, including under the balance of payments facility established by Regulation (EC) No 332/2002, and the sustainability of the general budget of the Union. Such examination shall not affect the irrevocable, unconditional and on-demand nature of the guarantees provided pursuant to paragraph 2. In the call on guarantees, the Commission shall inform the Member States about the extent to which the margin has been drawn. 6. Amounts resulting from calls on guarantees referred to in paragraph 2 shall constitute external assigned revenue for the Instrument in accordance with Article 21(5) of Regulation (EU, Euratom) 2018/1046. Article 12 Availability of the Instrument 1. The Instrument shall only become available after all Member States have contributed to the Instrument in accordance with Article 11 for an amount representing at least 25 per cent of the maximum amount referred to in Article 5, provided that the relative shares of contributions of each Member State of the overall amount of Member States\u2019 contributions correspond to the relative shares of Member States in the total gross national income of the Union, as resulting from column (1) of Table 3 of Part A (\u2018Introduction and financing of the general budget\u2019) of the revenue part of the budget for 2020 set out in the general budget of the Union for the financial year 2020, as adopted on 27 November 2019 (4). 2. The Commission shall inform the Council when the Instrument becomes available. 3. The period of availability of the Instrument during which a decision referred to in Article 6(1) may be adopted shall end on 31 December 2022. 4. Where the Commission concludes in the report referred to in Article 14 that the severe economic disturbance caused by the COVID-19 outbreak affecting the financing of measures referred to in Article 1 continues to exist, the Council, on a proposal from the Commission, may decide to extend the period of availability of the Instrument, each time for an additional period of six months. Article 13 Control and audits 1. The loan agreement shall contain the necessary provisions regarding controls and audits as required by Article 220(5) of Regulation (EU, Euratom) 2018/1046. 2. Where a request for financial assistance submitted in accordance with Article 3(1) is, fully or in part, based on planned public expenditure, the beneficiary Member State shall, every six months, inform the Commission about the implementation of such planned public expenditure. Article 14 Reporting 1. Within six months of the day on which the Instrument becomes available in accordance with Article 12 and every six months thereafter in the context of Article 250 of Regulation (EU, Euratom) 2018/1046, the Commission shall forward to the European Parliament, the Council, the Economic and Financial Committee and the Employment Committee a report on the use of financial assistance, including outstanding amounts and the applicable repayment schedule under the Instrument, and on the continuation of the exceptional occurrences that justify the application of this Regulation. 2. Where appropriate, the report referred to in paragraph 1 shall be accompanied by a proposal for a Council implementing decision extending the period of availability of the Instrument. Article 15 Applicability 1. This Regulation shall not be applicable to or in the United Kingdom. 2. References to \u2018Member States\u2019 in this Regulation shall not be understood to include the United Kingdom. Article 16 Entry into force This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 19 May 2020. For the Council The President G. GRLI\u0106 RADMAN (1) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (2) Council Regulation (EC) No 332/2002 of 18 February 2002 establishing a facility providing medium-term financial assistance for Member States\u2019 balances of payments (OJ L 53, 23.2.2002, p. 1). (3) OJ L 29, 31.1.2020, p. 7. (4) Definitive adoption (EU, Euratom) 2020/227 of the European Union\u2019s general budget for the financial year 2020 (OJ L 57, 27.2.2020, p. 1).", "summary": "Temporary support to mitigate unemployment risks in an emergency due to the COVID-19 outbreak (SURE) Temporary support to mitigate unemployment risks in an emergency due to the COVID-19 outbreak (SURE) SUMMARY OF: Regulation (EU) 2020/672 \u2014 establishment of a European instrument for temporary support to mitigate unemployment risks in an emergency (SURE) following the COVID-19 outbreak WHAT IS THE AIM OF THE REGULATION? Establishing the European instrument for temporary support to mitigate unemployment risks in an emergency (SURE), the regulation lays down the conditions and procedures that enable the EU to provide financial assistance to a Member State that is experiencing, or seriously threatened with, a severe economic disturbance caused by the COVID-19 outbreak. It primarily aims to finance short-time work schemes or similar measures aimed at protecting employees and the self-employed, thus mitigating the risk of unemployment and loss of income. It may also be used to finance as an ancillary, some health-related measures, in particular in the workplace. KEY POINTS Article 122(2) of the Treaty on the Functioning of the European Union allows the Council to grant EU financial assistance to Member States experiencing (or seriously threatened with) difficulties caused by exceptional occurrences beyond their control. Under the SURE regulation, a Member State may request EU financial assistance in support of national measures, such as short-time work schemes, to address the socioeconomic effects of the COVID-19 outbreak, where its actual (and possibly also planned) public expenditure has suddenly and severely increased after 1 February 2020. Financial assistance would be provided upon request, in the form of a loan, paid in installments. For this purpose, the European Commission and the Member State concerned would conclude a loan agreement in accordance with Article 220(5) of the EU\u2019s Financial Regulation (Regulation (EU, Euratom) 2018/1046 \u2014 see summary). To provide for the funding for the SURE Instrument, the Commission is empowered to borrow on the capital markets or with financial institutions on behalf of the EU at the most appropriate time to optimise the cost of funding and preserve its reputation as the EU\u2019s issuer in the markets. Member States may contribute to the SURE Instrument by counter-guaranteeing the risk thus borne by the EU. Such contributions are to be provided in the form of irrevocable, unconditional and on-demand guarantees. The amount of guarantee contributed by each Member State corresponds to its relative share in the total gross national income of the EU of the total amount of \u20ac25 billion. The Commission concludes a guarantee agreement with the contributing Member State, setting out the payment conditions. The maximum amount of financial assistance available under SURE is \u20ac100 billion for all Member States. The SURE Instrument aims to complement national measures taken by the affected Member States to mitigate the direct economic, social and health-related effects of the COVID-19 outbreak. Procedure for requesting and approving financial assistance Financial assistance is made available by means of a Council implementing decision adopted on the basis of a Commission proposal and after consultation with the Member State concerned. For this purpose, the Member State concerned provides the Commission with appropriate evidence related to the sudden and severe increase in actual (and possibly also planned) public expenditure directly related to short-time work schemes and similar measures, as well as, where appropriate, to relevant health-related measures, due to the COVID-19 outbreak. Prudential rules The Commission, on its part, is obliged to implement the following prudential rules applicable to the SURE loan portfolio: the share of loans granted to the 3 Member States representing the largest share of the loans may not exceed 60% of the maximum amount (i.e. 60% of \u20ac100 billion);the amounts due by the EU in a given year may not exceed 10% of the maximum amount of the SURE Instrument (i.e. 10% of \u20ac100 billion);where necessary, the Commission may roll over the associated borrowings contracted on behalf of the EU. The Council implementing decision will include: the amount of the loan, maximum average maturity, pricing formula, maximum number of installments, availability period and other relevant rules for the granting of the financial assistance;an assessment of the Member State\u2019s compliance with the conditions for using the SURE Instrument;a description of the national short-time work schemes or similar measures and, where appropriate, health-related measures, that may also be financed under the SURE regulation. When adopting the implementing decision, the Council considers the Member State\u2019s existing and expected needs as well as requests for SURE financial assistance already submitted or planned to be submitted by other Member States, while applying the principles of equal treatment, solidarity, proportionality and transparency. Administration, possible use of guarantees and availability of the SURE Instrument The Commission establishes the necessary arrangements for the administration of the loans with the European System of Central Banks. The beneficiary countries open special accounts with their national central bank to manage the financial assistance received. In the event that, in spite of the application of all the prudential rules, the Commission may need to call on the guarantees provided by Member States, it is expected, before calling on these guarantees, to examine whether it can draw on the margin available under the own-resources ceiling for payment appropriations, to the extent the Commission deems sustainable, having regard to, among other things, the total contingent liabilities of the EU and the sustainability of the general budget of the EU. The SURE Instrument will become available once all Member States have contributed their share of the guarantees (see above). The period of availability of the SURE Instrument during which a Council implementing decision granting the financial assistance may be adopted ends on 31 December 2022. The Council, following a proposal from the Commission, may decide to extend the period of availability of the SURE Instrument, each time for an additional period of 6 months, where the Commission concludes that the severe economic disturbance caused by the COVID-19 outbreak affecting the financing of the relevant measures continues to exist. The regulation does not apply in the United Kingdom. FROM WHEN DOES THE REGULATION APPLY? The regulation entered into force on 20 May 2020. BACKGROUND See also: Temporary support to mitigate unemployment risks in an emergency (SURE) (European Commission). MAIN DOCUMENT Council Regulation (EU) 2020/672 of 19 May 2020 on the establishment of a European instrument for temporary support to mitigate unemployment risks in an emergency (SURE) following the COVID-19 outbreak (OJ L 159, 20.5.2020, pp. 1-7) RELATED DOCUMENTS Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222) Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Three \u2014 Union policies and internal actions \u2014 Title VIII \u2014 Economic and monetary policy \u2014 Chapter 1 \u2014 Economic policy \u2014 Article 122 (ex Article 100 TEC) (OJ C 202, 7.6.2016, p. 98) last update 31.08.2020"}
{"article": "22.1.2021 EN Official Journal of the European Union L 22/1 REGULATION (EU) 2021/23 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the European Central Bank (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Financial markets are pivotal for the functioning of modern economies. The more integrated they are, the greater the potential for efficient allocation of economic resources will be, potentially benefitting economic performance. However, in order to improve the functioning of the single market in financial services, it is important to have procedures in place to deal with effects of market turmoil and to ensure that if a financial institution or a financial market infrastructure that is active in this market faces financial distress or is at the point of failure, such an event does not de-stabilise the entire financial market and damage growth across the wider economy. (2) Central counterparties (CCPs) are key components of global financial markets, stepping in between participants to act as the buyer to every seller and the seller to every buyer, and playing a central role in processing financial transactions and managing exposures to diverse risks inherent in those transactions. CCPs centralise the handling of transactions and positions of counterparties, honour the obligations created by the transactions, and require adequate collateral from their members as margin and as contributions to default funds. (3) The integration of Union financial markets has resulted in CCPs evolving from primarily serving domestic needs and markets to constituting critical nodes in Union financial markets more widely. CCPs authorised in the Union today clear several product classes, including listed and over-the-counter (OTC) financial and commodity derivatives, cash equities, bonds and other products such as repos. They provide services across national borders to a broad range of financial and other institutions across the Union. While some CCPs remain focused on domestic markets, they are all systemically important at least in their home markets. (4) As a significant amount of the financial risk of the Union financial system is processed by and concentrated in CCPs on behalf of clearing members and their clients, effective regulation and robust supervision of CCPs are essential. Regulation (EU) No 648/2012 of the European Parliament and of the Council (4) requires CCPs authorised in the Union to observe high prudential, organisational and conduct of business standards. Competent authorities, working together within supervisory colleges which group together relevant authorities for the specific tasks allocated to them, are tasked with the full oversight of the activities of CCPs. In accordance with commitments entered into by G20 leaders since the 2008 financial crisis, Regulation (EU) No 648/2012 also requires standardised OTC derivatives to be centrally cleared by a CCP. As the obligation to centrally clear OTC derivatives comes into effect, the volume and range of business done by CCPs is likely to increase which could, in turn, provide additional challenges for risk management strategies of CCPs. (5) Regulation (EU) No 648/2012 has contributed to the increased resilience of CCPs and of wider financial markets against the broad range of risks processed and concentrated in CCPs. However, no system of rules and practices can prevent existing resources from being inadequate in managing the risks incurred by a CCP, including one or more defaults by clearing members. Faced with a scenario of severe financial distress or impending failure, financial institutions should in principle remain subject to normal insolvency proceedings. However, as the 2008 financial crisis has shown, in particular during a period of prolonged economic instability and uncertainty, such proceedings can disrupt functions critical to the economy, jeopardising financial stability. Normal corporate insolvency procedures may not always ensure sufficient speed of intervention or adequately prioritise the continuity of the critical functions of financial institutions for the sake of preserving financial stability. In order to prevent such negative consequences of normal insolvency proceedings, it is necessary to create a special resolution framework for CCPs. (6) The 2008 financial crisis highlighted the lack of adequate tools to preserve the critical functions provided by failing financial institutions. It further demonstrated the absence of frameworks to enable cooperation and coordination amongst authorities, in particular those located in different Member States or jurisdictions, to ensure the taking of swift and decisive action. Without such tools and in the absence of cooperation and coordination frameworks, Member States were compelled to rescue financial institutions using taxpayer money in order to stem contagion and reduce panic. While CCPs were not direct recipients of extraordinary public financial support in the 2008 financial crisis, they were protected from the effects that banks failing to perform their obligations would otherwise have had on them. A recovery and resolution framework for CCPs complements the bank resolution framework adopted under Directive 2014/59/EU of the European Parliament and of the Council (5), and is therefore necessary to prevent reliance on taxpayer money in the event of their disorderly failure. Such a framework should also address the possibility of CCPs entering into resolution for reasons other than the default of one or several of their clearing members. (7) The objective of a credible recovery and resolution framework is to ensure, to the greatest extent possible, that CCPs set out measures to recover from financial distress, to maintain the critical functions of a CCP which is failing or likely to fail while winding up the remaining activities through normal insolvency proceedings, and to preserve financial stability and to avoid a significant adverse effect on the financial system and its ability to serve the real economy while minimising the cost to taxpayers of a CCP failure. A recovery and resolution framework further bolsters the preparedness of CCPs and authorities to mitigate financial distress and provide authorities with further insight into CCPs\u2019 preparations for stress scenarios. It also provides authorities with powers to prepare for the potential resolution of a CCP and deal with the declining health of a CCP in a coordinated manner, thus contributing to the smooth functioning of financial markets. (8) Currently, there are no harmonised provisions for the recovery and resolution of CCPs across the Union. Some Member States have already enacted legislative changes that require CCPs to draw up recovery plans and that introduce mechanisms to resolve failing CCPs. Furthermore, there are considerable substantive and procedural differences between Member States on the laws, regulations and administrative provisions which govern the insolvency of CCPs. The absence of common conditions, powers and processes for the recovery and resolution of CCPs is likely to constitute a barrier to the smooth functioning of the internal market and hinder cooperation between national authorities when dealing with the failure of a CCP and applying appropriate loss allocation mechanisms on its clearing members, both in the Union and globally. This is particularly true where different approaches mean that national authorities do not have the same level of control or the same ability to resolve CCPs. Those differences in recovery and resolution regimes might affect CCPs, clearing members and the clients of clearing members differently across Member States, potentially creating competitive distortions across the internal market. The absence of common rules and tools for how financial distress or failure in a CCP should be handled can affect clearing members\u2019 and their clients\u2019 choice to clear and CCPs\u2019 choice of their place of establishment, thereby preventing CCPs from fully benefiting from their fundamental freedoms within the internal market. In turn, this could discourage clearing members and their clients from accessing CCPs across borders in the internal market and hinder further integration in the Union\u2019s capital markets. Common recovery and resolution rules in all Member States are therefore necessary to ensure that CCPs are not limited in exercising their internal market freedoms by the financial capacity of Member States and their authorities to manage their failure. (9) The review of the regulatory framework applicable to banks and to other financial institutions which has taken place in the wake of the 2008 financial crisis, and in particular the strengthening of banks\u2019 capital and liquidity buffers, better tools for macro-prudential policies and comprehensive rules on the recovery and resolution of banks, have reduced the likelihood of future crises and enhanced the resilience of all financial institutions and market infrastructures, including CCPs, to economic stress, whether caused by systemic disturbances or by events specific to individual institutions. Since 1 January 2015, a recovery and resolution regime for banks has applied in Member States pursuant to Directive 2014/59/EU. (10) Building on the approach for bank recovery and resolution, competent authorities and resolution authorities should be prepared and have adequate tools at their disposal to handle situations involving CCP failures. However, due to their different functions and business models, the risks inherent in banks and CCPs are different. Specific tools and powers are therefore needed for CCP failure scenarios caused by the failure of the CCP\u2019s clearing members or as a result of non-default events. (11) A regulation is the proper legal act to choose in order to complement and build on the approach established by Regulation (EU) No 648/2012, which provides for uniform prudential requirements applicable to CCPs. Setting recovery and resolution requirements in a directive could create inconsistencies by the adoption of potentially different national rules in respect of an area otherwise governed by directly applicable Union law and increasingly characterised by the cross-border provision of CCPs\u2019 services. Therefore uniform and directly applicable rules on recovery and resolution of CCPs should also be adopted. (12) In order to ensure consistency with existing Union legislation in the area of financial services, as well as the greatest possible level of financial stability across the Union, the recovery and resolution regime laid down in this Regulation should apply to CCPs that are subject to the prudential requirements laid down in Regulation (EU) No 648/2012, regardless of whether they have a banking licence. While there might be differences in the risk profile associated with alternative corporate structures, CCPs are stand-alone entities that are required to fulfil all requirements under this Regulation and under Regulation (EU) No 648/2012 independently from their parent undertaking or other group entities. The group of which a CCP forms part does not therefore need to be subject to this Regulation. The group dimension, including, inter alia, the operational, personal and financial relations of a CCP with group entities, should, however, be taken into account in the CCP\u2019s recovery and resolution planning insofar it could affect the recovery or resolution of the CCP or insofar recovery and resolution actions could have an impact on other entities of the group. (13) In order to ensure that resolution actions are taken efficiently and effectively, and in line with resolution objectives, Member States should appoint, as resolution authorities for the purpose of this Regulation, national central banks, competent ministries, public administrative authorities or authorities entrusted with public administrative powers to perform functions and tasks in relation to resolution, including any existing resolution authorities. Member States should also ensure that appropriate resources are allocated to those resolution authorities. In Member States where a CCP is established, adequate structural arrangements should be put in place to separate the CCP resolution functions from other functions, in particular where the authority responsible for the prudential supervision of the CCP, or prudential supervision of credit institutions or investment firms that are clearing members of the CCP, is designated as the resolution authority, to avoid any conflicts of interest and risk of regulatory forbearance. In such cases, the independence of the resolution authority\u2019s decision-making process should be ensured, while not preventing decision-making from converging at the highest level. (14) In light of the consequences that the failure of a CCP and the subsequent actions might have on the financial system and the economy of a Member State, as well as the possible ultimate need to use public funds to resolve a crisis, the Ministries of Finance or other relevant ministries in Member States should be able to decide, in line with national democratic procedures, on the use of public funds as a last resort and should consequently be closely involved, at an early stage, in the process of recovery and resolution. Therefore, with regard to the use of public funds as a last resort, this Regulation should be without prejudice to the distribution of competences between the relevant ministries or the government and the resolution authority as provided for in the legal systems of Member States. (15) As CCPs often provide services across the Union, effective recovery and resolution requires cooperation among competent authorities and resolution authorities within supervisory and resolution colleges, notably at the preparatory stages of recovery and resolution. That includes assessing the recovery plan developed by the CCP, contributing to and reaching a joint decision on resolution plans drawn up by the resolution authority of the CCP, and addressing any impediments to resolvability of the CCP. (16) The resolution of CCPs should strike the balance between the need, on the one hand, for procedures that take into account the urgency of the situation and allow for efficient, fair and timely solutions and, on the other, the necessity to protect financial stability in the Member States where the CCP provides services. The authorities whose areas of competence would be affected by the failure of a CCP should share their views in the resolution college to achieve those objectives. This should include in particular sharing information on the preparation of clearing members and, where relevant, clients with regard to potential default management, recovery and resolution measures and the supervisory treatment of the related exposures towards the CCP. The authorities of Member States whose financial stability could be impacted by the failure of the CCP should be able to participate in the resolution college based on their assessment of the impact that the CCP\u2019s resolution could have on financial stability in their respective Member State. Member States should have the possibility to be represented in the resolution college by the competent authorities and resolution authorities of clearing members. Member States which are not represented by clearing members\u2019 authorities should be able to participate by choosing between participation in the college of the competent authority of clearing members\u2019 clients and of the resolution authority of clearing members\u2019 clients. The authorities should provide appropriate justification for their participation, based on their analysis of the negative impact that the CCP\u2019s resolution could have on their Member States, to the resolution authority of the CCP. Similarly, in order to ensure a regular exchange of views and coordination with relevant third-country authorities, these should be invited to participate in resolution colleges as observers where necessary. (17) In order to address the potential failure of a CCP in an effective and proportionate manner, authorities should take into account a number of factors when exercising their recovery and resolution powers such as the nature of the CCP\u2019s business, ownership structure, legal and organisational structure, risk profile, size, legal status, substitutability and interconnectedness to the financial system. The authorities should also take account of whether its failure and subsequent winding up under normal insolvency proceedings would be likely to have a significant negative effect on financial markets, on other financial institutions, or on the wider economy. (18) In order to deal in an efficient manner with failing CCPs, competent authorities should have the power to impose preparatory measures on CCPs. A minimum standard should be established as regards the contents and information to be included in recovery plans to ensure that all CCPs in the Union have sufficiently detailed recovery plans should they face financial distress. Such recovery plan should contemplate an appropriate range of scenarios, envisaging both systemic and specific stresses to the CCP, that would endanger its viability, also taking into account the potential impact of contagion in a crisis, both domestic and cross-border. The scenarios should be more severe than those used for the purposes of regular stress testing pursuant to Article 49 of Regulation (EU) No 648/2012, while remaining plausible. The recovery plan should cover a broad range of scenarios including scenarios resulting from default events, non-default events and a combination of both; and should include comprehensive arrangements for the re-establishment of a matched book, for the full allocation of losses arising from clearing member default, and adequate absorbency for all other types of losses. Recovery plans should distinguish between different types of non-default events. The recovery plan should form part of the operating rules of the CCP agreed contractually with clearing members. Those operating rules should further contain provisions to ensure the enforceability of recovery measures outlined in the recovery plan in all scenarios. Recovery plans should not assume access to extraordinary public financial support or expose taxpayers to the risk of loss. (19) CCPs should be required to draw up and regularly review and update their recovery plans. The recovery phase in that context should start when there is a significant deterioration in the CCP\u2019s financial situation or risk of breach of its capital and prudential requirements under Regulation (EU) No 648/2012 that could lead to the infringement of its authorisation requirements that would justify the withdrawal of its authorisation pursuant to Regulation (EU) No 648/2012. This should be indicated with reference to a framework of qualitative or quantitative indicators included in the recovery plan. (20) In order to create sound incentives ex-ante and to ensure a fair allocation of losses, recovery plans should ensure that the application of recovery tools appropriately balances the allocation of losses between CCPs, clearing members and, where applicable, their clients. As a general principle, losses in recovery should be distributed between CCPs, clearing members, and, where applicable, their clients as a function of their responsibility for the risk transferred to the CCP and their ability to control and manage such risks. Recovery plans should ensure that the CCP\u2019s capital is exposed to losses caused by both default and non-default events, before losses are allocated to clearing members. As an incentive for proper risk management and to further reduce the risks of losses for the taxpayer, the CCP should use a portion of its pre-funded dedicated own resources as referred to in Article 43 of Regulation (EU) No 648/2012, which can include any capital it holds in addition to its minimum capital requirements, to comply with the notification threshold referred to in the delegated act adopted on the basis of Article 16(3) of Regulation (EU) No 648/2012, as a recovery measure before resorting to other recovery measures requiring financial contributions from clearing members. That additional amount of pre-funded dedicated own resources, which is distinct from the pre-funded own resources referred to in Article 45(4) of Regulation (EU) No 648/2012, should not be lower than 10 % nor higher than 25 % of the risk based capital requirements calculated in accordance with Article 16(2) of Regulation (EU) No 648/2012 irrespective of whether those requirements are lower or higher than the initial capital referred to in Article 16(1) of that Regulation. (21) The CCP should submit its recovery plan to the competent authority which should without undue delay transmit the plan to the supervisory college, established under Regulation (EU) No 648/2012, for a complete assessment, to be carried out by joint decision of the college. The assessment should include whether the plan is comprehensive and whether it could feasibly restore the viability of the CCP, in a timely manner, including in periods of severe financial distress. (22) Recovery plans should comprehensively set out the actions that the CCP would take to address any unmatched outstanding obligations, uncovered loss, liquidity shortfall, or capital inadequacy, as well as the actions to replenish any depleted pre-funded financial resources and liquidity arrangements in order to restore the CCP\u2019s viability and its continuing ability to meet its requirements for authorisation. Neither the power of the resolution authority to apply a resolution cash call nor the requirement to have a minimum contractual commitment for the recovery cash call should affect the right of the CCP to introduce recovery cash calls in its rules above the minimum obligatory contractual commitment specified in this Regulation or the risk management of the CCP. (23) Recovery plans should also consider cyber-attacks which could lead to a significant deterioration of the financial situation of the CCP or to a risk of breaching prudential requirements under Regulation (EU) No 648/2012. (24) CCPs should ensure that their recovery plan is non-discriminatory and balanced in terms of its impact and the incentives it creates. The effects of the recovery measures on clearing members and, where the relevant information is available, their clients and on the financial system of the Union or of one or more of its Member States more broadly should be proportionate. In particular, in accordance with Regulation (EU) No 648/2012 CCPs have to ensure that their clearing members have limited exposures toward the CCP. CCPs should ensure that all relevant stakeholders are involved in the drawing-up of the recovery plan through their involvement in the CCP\u2019s risk committee, as the case might be, and by being appropriately consulted. Since opinions can be expected to differ among stakeholders, CCPs should establish clear processes to manage the diversity of stakeholders\u2019 views as well as any conflict of interest between those stakeholders and the CCP. (25) In view of the global nature of the markets served by CCPs, the CCP\u2019s operating rules should include contractual provisions to ensure its ability to apply the recovery options, where necessary, to contracts or assets governed by the law of a third country or to entities based in third countries. (26) Where a CCP does not present an adequate recovery plan, competent authorities should be able to require the CCP to take the measures necessary to redress the material deficiencies of the plan in order to strengthen the business of the CCP and ensure that the CCP could allocate losses, restore its capital and, where relevant, re-match its book in the event of failure. That power should allow competent authorities to take preventive action to the extent that it is necessary to address any deficiencies and, therefore, to meet the objectives of financial stability. (27) In the exceptional cases of variation margin gains haircutting following a non-default event and if recovery is successful, the competent authority should be able to require the CCP to recompense its clearing members proportionately to their loss in excess of their contractual commitments, through cash payments or, where appropriate, to require the CCP to issue instruments recognising a claim on the future profits of the CCP. (28) Resolution planning is an essential component of effective resolution. The plans should be drawn up by the resolution authority of the CCP and jointly agreed in the resolution college. The plans should cover a broad range of scenarios, distinguishing scenarios resulting from default events, non-default events and a combination of both, as well as different types of non-default events. Authorities should have all the information necessary to identify and ensure the continuity of critical functions. The content of a resolution plan should, however, be appropriate to the activities of the CCP and the types of products it clears and it should be based, inter alia, on the information provided by it. In order to facilitate the enforcement of resolution cash calls and of the reduction of the amount of any gains payable to a non-defaulting clearing member of a CCP under resolution, a reference to the power of the resolution authority to require such resolution cash calls and such reduction should be included in the operating rules of the CCP. Where needed, the operating rules of the CCP that are agreed contractually with clearing members should contain provisions to ensure the enforceability of other resolution measures by resolution authorities. (29) Resolution authorities, on the basis of the assessment of resolvability, should have the power to require changes to the legal or operational structure and organisation of CCPs directly or indirectly through the competent authority, to take measures which are necessary and proportionate to reduce or remove material impediments to the application of resolution tools and ensure their resolvability. Taking into account the diverse structure of the groups that CCPs belong to, the differences in structures compared to banking groups, and the different regulatory frameworks that apply to individual entities within such groups, the resolution authority of the CCP, in consultation with the competent authority of the CCP, should be able to assess whether enforcing changes to the legal or operational structures of the CCP, or any group entity directly or indirectly under its control, involves changes in the structures of the group that the CCP belongs to that could lead to issues of legal challenge or issues of enforceability, depending on the specific legal circumstances that apply. The resolution authority, when assessing how to remove such impediments to resolution, should be able to suggest a different set of resolvability measures than requiring changes to the legal or operational structures of the group, if the use of such alternative measures would remove the impediments to resolvability in an equivalent way. (30) As regards resolution plans and resolvability assessments day-to-day supervisory considerations are outweighed by the need to expedite and ensure swift restructuring actions in order to secure a CCP\u2019s critical functions and safeguard financial stability. In the event of disagreement between the different members of the resolution college on decisions to be taken with regard to the CCP\u2019s resolution plan, the assessment of the CCP\u2019s resolvability and the decision to remove any impediments thereto, the European Supervisory Authority (European Securities and Markets Authority) (ESMA) should play a mediation role in accordance with Article 19 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (6). Such binding mediation by ESMA should nonetheless be prepared for consideration by an ESMA internal committee, in view of the competences of ESMA members to ensure financial stability and to oversee clearing members in several Member States. Certain competent authorities under the Regulation (EU) No 1093/2010 of the European Parliament and of the Council (7) should be invited to participate as observers to that ESMA internal committee in view of the fact that such authorities carry out similar tasks under Directive 2014/59/EU. Such binding mediation should not prevent non-binding mediation in accordance with Article 31 of Regulation (EU) No 1095/2010 in other cases. In accordance with Article 38 of Regulation (EU) No 1095/2010, such binding mediation may not impinge on the fiscal responsibilities of Member States. (31) It could be necessary for the recovery plan of the CCP to set out the conditions under which the provision of possible contractually binding financial support agreements, guarantees or other forms of operational support from a parent undertaking or another group entity to a CCP within the same group would be triggered. Transparency regarding such arrangements would mitigate risks to the liquidity and solvency of the group entity providing support to a CCP facing financial distress. Therefore, any change to such arrangements affecting the quality and nature of such group support should be considered a material change for the purpose of reviewing the recovery plan. (32) Given the sensitivity of the information contained in the recovery and resolution plans, those plans should be subject to appropriate confidentiality provisions. (33) Competent authorities should transmit the recovery plans and any changes thereto to the relevant resolution authorities, and the latter should transmit the resolution plans and any changes thereto to competent authorities, thus permanently keeping every relevant authority fully informed. (34) In order to preserve financial stability, it is necessary that competent authorities are able to remedy the deterioration of a CCP\u2019s financial and economic situation before that CCP reaches a point at which authorities have no other alternative but to resolve it or to direct the CCP to change its recovery measures where they could be detrimental for overall financial stability. Competent authorities should therefore be granted early intervention powers to avoid or minimise adverse effects on financial stability or on the interests of clients that could result from the CCP\u2019s implementation of certain measures. Early intervention powers should be conferred on competent authorities in addition to their powers provided for in the national law of Member States or under Regulation (EU) No 648/2012 for circumstances other than those considered to be early intervention. Early intervention powers should include the power to restrict or prohibit any remuneration of equity and instruments treated as equity, including dividend payments and buybacks by the CCP, to the fullest extent possible without triggering an event of default, and also the power to restrict, prohibit or freeze any payments of variable remuneration as defined by the CCP\u2019s remuneration policy pursuant to Article 26(5) of Regulation (EU) No 648/2012, discretionary pension benefits or severance packages to senior management. (35) In the framework of early intervention powers, and in accordance with the relevant provisions under national law, the competent authority should be able to appoint a temporary administrator, either to replace or to temporarily work with the board and senior management of the CCP. The task of the temporary administrator should be to exercise any powers conferred on it, subject to any condition imposed on it upon its appointment, with a view to promoting solutions to redress the financial situation of the CCP. The appointment of the temporary administrator should not unduly interfere with the rights of the shareholders or owners or with procedural obligations established under Union or national company law and should respect international obligations of the Union and Member States, relating to investment protection. (36) During the recovery and early intervention phases, shareholders should retain their rights in full. They should lose such rights once the CCP has been put under resolution. Any remuneration of equity and instruments treated as equity, including dividend payments and buybacks by the CCP, should be restricted or prohibited in recovery, to the fullest extent possible without triggering an event of default. Equity holders of a CCP should absorb losses first in resolution in a way that minimises the risk of legal challenge by them where such losses are greater than the losses that they would have incurred under normal insolvency proceedings also known as the \u2018no creditor worse off\u2019 principle. A resolution authority should be able to deviate from the \u2018no creditor worse off\u2019 principle. However, a shareholder or a creditor incurring greater loss than it would have incurred under normal insolvency proceedings would be entitled to the payment of the difference. (37) The resolution framework should provide for timely entry into resolution before a CCP is insolvent. A CCP should be considered to be failing or likely to fail when it infringes or is likely in the near future to infringe the requirements for continuing authorisation, when its recovery has failed or is likely to fail to restore its viability, when the CCP is unable or is likely to be unable to provide a critical function, when the assets of the CCP are or are likely in the near future to be less than its liabilities, when the CCP is or is likely in the near future to be unable to pay its debts or other liabilities as they fall due, or when the CCP requires extraordinary public financial support. However, the fact that a CCP does not comply with all the requirements for authorisation should not justify by itself the entry into resolution. (38) The provision of emergency liquidity assistance from a central bank, where such a facility is available, should not be a condition that demonstrates that a CCP is or will be, in the near future, unable to pay its liabilities as they fall due. In order to preserve financial stability, in particular in the case of a systemic liquidity shortage, State guarantees on liquidity facilities provided by central banks or State guarantees of newly issued liabilities to remedy a serious disturbance in the economy of a Member State should not trigger entry into resolution, provided that a number of conditions are met. (39) Members of the European System of Central Banks (ESCB), other Member States\u2019 bodies performing similar functions, other Union public bodies charged with or intervening in the management of the public debt, and the Bank for International Settlements as well as other entities listed in Article 1(4) and (5) of Regulation (EU) No 648/2012 can act in the capacity of a clearing member in connection with their operations. Loss allocation tools envisaged in the recovery plan of CCPs should not apply to those entities. Similarly, resolution authorities should not apply loss allocation tools with regard to those entities, in order to avoid the exposure of public money. (40) Where a CCP meets the conditions for resolution, the resolution authority of the CCP should have at its disposal a harmonised set of resolution tools and powers. They should enable the resolution authority to address scenarios caused both by default and non-default events, or a combination of both. Their exercise should be subject to common conditions, objectives, and general principles. In particular, the application of such tools or powers should not impinge on the effective resolution of cross-border groups. (41) The prime objectives of resolution should be to ensure the continuity of critical functions, to avoid adverse effects on financial stability, and to protect public funds. (42) The critical functions of a failing CCP should be maintained, although re-structured with changes to the management where appropriate, through the application of resolution tools and, to the largest extent possible, with the use of private funds and without reliance on extraordinary public financial support. That objective could be achieved by allocating outstanding losses and restoring the CCP to a matched book through application of the position and loss allocation tools in the case of default losses, or, in the case of non-default losses, through the write-down of equity instruments and the write-down and conversion to equity of unsecured liabilities to absorb losses and recapitalise the CCP. To prevent the need for the application of government stabilisation tools, the resolution authority should also be able to use the resolution cash call following a non-default event. A CCP or specific clearing service should also be able to be sold to or merged with a solvent third-party CCP that is able to conduct and manage the transferred clearing activities. In line with the objective of maintaining the critical functions of the CCP and prior to taking the actions described above, the resolution authority should generally enforce any existing and outstanding contractual obligations towards the CCP in line with how they would be called in its operating rules, including in particular any contractual obligations by clearing members to meet recovery cash calls or to take on positions of defaulting clearing members, whether through an auction or other agreed means in the CCP\u2019s operating rules, as well as any existing and outstanding contractual obligations committing parties other than clearing members to any forms of financial support. (43) Rapid and decisive action is necessary to sustain market confidence and minimise contagion. Once the conditions for resolution have been met, the resolution authority of the CCP should not delay in taking appropriate and coordinated resolution action in the public interest. The failure of a CCP can occur in circumstances that require an immediate reaction by the relevant resolution authority. That authority should therefore be allowed to take resolution actions notwithstanding the exercise of recovery measures by the CCP or without imposing an obligation to first use the early intervention powers. (44) When taking resolution actions, the resolution authority of the CCP should take into account and follow the measures provided for in the resolution plans drawn up within the resolution college, unless the resolution authority considers, taking into account the circumstances of the case, that the resolution objectives will be achieved more effectively by taking actions which are not provided for in the resolution plans. The resolution authority should take into account the general principles of decision-making, including the need to balance the interests of different stakeholders of the CCP and to ensure transparency towards and involvement of the relevant authorities of Member States where the proposed decision or action could have implications on the financial stability or fiscal resources. In particular, the resolution authority should inform the resolution college of the planned resolution actions, including where such actions deviate from the resolution plan. (45) Interference with property rights should be proportionate to the financial stability risk. Resolution tools should therefore be applied only with respect to those CCPs that meet the conditions for resolution, specifically where it is necessary to pursue the objective of financial stability in the public interest. Resolution tools and powers could disrupt the rights of shareholders, creditors, clearing members and, where applicable, clients of clearing members. Resolution action should therefore be taken only where necessary in the public interest and any interference with those rights should be compatible with the Charter of Fundamental Rights of the European Union (\u2018the Charter\u2019). (46) Affected shareholders, clearing members and other creditors of the CCP should not incur losses greater than those which they would have incurred if the resolution authority had not taken resolution action in relation to the CCP and they had instead been subject to all applicable outstanding obligations pursuant to the CCP\u2019s default rules or other contractual arrangements in its operating rules, and the CCP had been wound up in normal insolvency proceedings (\u2018no creditor worse off\u2019 principle). In the event of a partial transfer of assets of a CCP under resolution to a private purchaser or to a bridge CCP, the residual part of the CCP under resolution should be wound up under normal insolvency proceedings. (47) For the purpose of protecting the rights of shareholders, of clearing members and of other creditors, clear rules should be laid down concerning the valuation of the assets and liabilities of the CCP and the valuation of the treatment that shareholders, clearing members and other creditors would have received if the resolution authority had not taken resolution action. This should compare the treatment that shareholders, clearing members and other creditors have actually been afforded in resolution and the treatment they would have received if the resolution authority had not taken resolution action in relation to the CCP and if they had instead been subject to possible outstanding obligations pursuant to the CCP\u2019s recovery plan or other arrangements in its operating rules and the CCP had been wound up in normal insolvency proceedings. The use of the resolution cash call, which should be included in the CCP\u2019s operating rules, is reserved for the resolution authority. It cannot be used by the CCP, or an administrator or liquidator in insolvency and it should therefore not be part of the treatment that shareholders, clearing members and other creditors would have received if the resolution authority had not taken resolution action. Any use of the power to reduce the amount of any gains payable to a non-defaulting clearing member by the resolution authority that exceeds contractually agreed limits for such a reduction should also not be part of the treatment that shareholders, clearing members and other creditors would have received if the resolution authority had not taken resolution action. Where shareholders, clearing members and other creditors have received, in payment of, or compensation for, their claims, less than the amount that they would have received if the resolution authority had not taken resolution action in relation to the CCP and they had instead been subject to possible outstanding obligations pursuant to the CCP\u2019s default rules or other contractual arrangements in its operating rules and the CCP had been wound up in normal insolvency proceedings, they should be entitled to the payment of the difference. Clients should only be included in that comparison and should only be entitled to the payment of any difference in treatment when there is a contractual basis for a direct claim from clients against the CCP, making them creditors of the CCP. Only in such cases can the resolution authority control the direct impact of its actions. It should be possible to challenge that comparison separately from the resolution decision. Member States should be free to decide on the procedure as to how to pay any difference of treatment that has been determined to shareholders, clearing members and other creditors. (48) Recovery and resolution actions can indirectly affect clients and indirect clients that are not creditors of the CCP, to the extent that costs of recovery and resolution have been passed to those clients and indirect clients under the applicable contractual arrangements. Therefore, the impact of a CCP recovery and resolution scenario on clients and indirect clients should also be addressed through the same contractual arrangements with the clearing members and clients that provide them with clearing services. This can be achieved by ensuring that, if contractual arrangements allow clearing members to pass on to their clients the negative consequences of the resolution tools, those contractual arrangements also include, on an equivalent and proportionate basis, the right of clients to any compensation clearing members receive from the CCP or any cash equivalent of such compensation or any proceeds they receive following a \u2018no creditor worse off\u2019 claim, to the extent that these relate to client positions. Such provisions should also apply to the contractual arrangements by clients and indirect clients offering indirect clearing services to their clients. (49) To ensure the effective resolution of a CCP, the valuation process should determine as accurately as possible any losses that need to be allocated for the CCP to re-establish a matched book of outstanding positions and to meet ongoing payment obligations. The valuation of assets and liabilities of a failing CCP should be based on fair, prudent and realistic assumptions at the moment when the resolution tools are applied. The value of liabilities should not, however, be affected in the valuation by the financial state of the CCP. It should be possible, for reasons of urgency, for resolution authorities to make a rapid valuation of the assets or the liabilities of a failing CCP. That valuation should be provisional and should apply until an independent valuation is carried out. (50) Upon entry into resolution of the CCP, the resolution authority should enforce any outstanding contractual obligations set out in the operating rules of the CCP, including outstanding recovery measures, except where the exercise of another resolution power or tool is more appropriate to mitigate adverse effects for financial stability or to secure the critical functions of the CCP in a timely manner. The resolution authority should have the right, but not the obligation, to enforce those contractual obligations still after resolution if the reasons for refraining from their enforcement no longer exist. In order to allow for the clearing members and other relevant parties to prepare for the enforcement of the remaining obligations, the resolution authority should notify the relevant clearing members and other parties in advance. That pre-notification period should be from three to six months. The resolution authority should determine, in consultation with the competent authorities and resolution authorities of the affected clearing members and any other parties committed by existing and outstanding obligations, whether the reasons for refraining from enforcing the contractual obligations have ceased to exist and whether to enforce the remaining obligations. If the reasons continue to exist, the resolution authority should refrain from enforcing those obligations. The proceeds from the delayed enforcement of the outstanding contractual obligations should be used to recover any public funds used for the payment of \u2018no creditor worse off\u2019 claims resulting from the resolutions authority\u2019s decision to refrain from enforcing those obligations or the application of any government stabilisation tool. The resolution authority should use this power of delayed enforcement only to the extent that the \u2018no creditor worse off\u2019 safeguard is not breached with respect to the stakeholder that will be subject to the delayed enforcement. In the case of default losses, the resolution authority should restore the CCP to a matched book and allocate outstanding losses through application of position and loss allocation tools. In the case of non-default losses, losses should be absorbed by regulatory capital instruments and should be allocated to shareholders up to their capacity either through the cancellation or transfer of instruments of ownership or through severe dilution. Where those instruments are not sufficient, resolution authorities should have the power to write-down unsecured debt and liabilities, in accordance with their ranking under applicable national insolvency law, and apply loss allocation tools, to the extent necessary without jeopardising broader financial stability. (51) If, after losses have been absorbed and, where applicable, the CCP has been restored to a matched book and the pre-funded resources of the CCP remain depleted, the resolution authority should ensure that those resources are restored to the levels necessary to meet regulatory requirements, either through the continued exercise of the tools in the CCP\u2019s operating rules or through other actions. In particular, resolution authorities should have the possibility to compensate non-defaulting clearing members that would have been entitled to a \u2018no creditor worse off\u2019 compensation payment for the application of loss allocation tools that would result in losses in excess of those that the clearing members would have borne under their obligations under the CCP\u2019s operating rules with instruments of ownership, debt instruments or instruments recognising a claim on the CCP\u2019s future profits. When assessing the amount and the form of compensation, the resolution authority can consider, for example, the financial soundness of the CCP, and the quality of instruments available for compensation and for meeting the \u2018no creditor worse off\u2019 safeguard. To maintain an adequate incentive structure, such compensation should reflect the extent to which a clearing member has supported the recovery of the CCP and therefore also take into account the remaining outstanding contractual obligations of the clearing members towards that CCP. Such compensation should be deducted from any entitlement to a \u2018no creditor worse off\u2019 payment. (52) Resolution authorities should also ensure that the costs of the resolution of the CCP are minimised and that creditors of the same class are treated in an equitable manner. The resolution authority should be able to take a resolution action which deviates from the principle of equal treatment of creditors if it is justified in the public interest to achieve the resolution objectives and is proportionate to the risk addressed. If the resolution authority uses such measure it should not discriminate anybody on the basis of nationality. (53) The resolution of a CCP should not entail calling on extraordinary public financial support. The outstanding recovery tools and resolution tools, in particular the write-down tool, should be applied to the fullest extent possible before or together with any public sector injection of capital or equivalent extraordinary public financial support is given to a CCP. The use of extraordinary public financial support to assist in the resolution of failing institutions is to be a last resort, be limited in time and comply with the relevant State aid provisions. (54) An effective resolution regime should minimise the costs of the resolution of a failing CCP borne by the taxpayers. It should ensure that CCPs can be resolved without jeopardising financial stability. The write-down tool and the loss and position allocation tools should achieve that objective by ensuring that shareholders and counterparties who are among the creditors of the failing CCP suffer appropriate losses and bear an appropriate part of the costs arising from the failure of the CCP. The write-down and the loss and position allocation tools therefore give shareholders and counterparties of CCPs a stronger incentive to monitor the health of a CCP during normal circumstances in accordance with the recommendations of the Financial Stability Board (FSB) provided for in its document \u2018Key Attributes of Effective Resolution Regimes for Financial Institutions\u2019. (55) In order to ensure that resolution authorities have the necessary flexibility to allocate losses and positions to counterparties in a range of circumstances, it is appropriate that those authorities should be able to apply the position and loss allocation tools both where the objective is to maintain critical clearing services within the CCP under resolution and in conjunction with the transfer of critical services to a bridge CCP or a third party after which the residual part of the CCP ceases to operate and is wound up. (56) Where the position and loss allocation tools are applied with the objective of restoring the viability of the failing CCP to enable it to continue to operate as a going concern, the resolution should be accompanied by replacement of management, except where retention of management is appropriate and necessary for the achievement of the resolution objectives, and a subsequent restructuring of the CCP and its activities in a way that addresses the reasons for its failure. That restructuring should be achieved through the implementation of a business reorganisation plan, which should be compatible with the restructuring plan that the CCP might be required to submit pursuant to the State aid framework. (57) The position and loss allocation tools should be exercised with a view to re-matching the CCP\u2019s book, stemming any further losses and obtaining additional resources to help recapitalise the CCP and replenish its pre-funded resources. In order to ensure that they are effective and achieve their objective, they should be able to apply to as wide a range of contracts giving rise to unsecured liabilities or creating an unmatched book for the failing CCP as possible. They should provide for the possibility to auction defaulters\u2019 positions among remaining clearing members or to forcibly allocate them to the extent that voluntary arrangements established as part of recovery plan are not exhausted upon entry into resolution, to partially or fully terminate the contracts of defaulted clearing members, of an affected clearing service or asset class and other contracts of the CCP, to further haircut outgoing variation margin payments to such members and, where applicable, their clients, to exercise any outstanding recovery cash calls set out in recovery plans, and to exercise additional resolution cash calls and write-down of capital and debt instruments issued by the CCP or other unsecured liabilities and a conversion of any debt instruments into shares. This includes the possibility to apply the loss allocation tools to contribute to the restoration of a matched book by providing the CCP with funds to accept an auction bid, enabling the CCP to allocate the defaulter\u2019s positions or to make payments on the terminated contracts. (58) When applying the loss allocation tool that allows the reduction of the value of any gains payable by the CCP to non-defaulting clearing members, the resolution authority should rely on processing of variation margin in accordance with the CCP\u2019s account structure, the operation of the reduction of the value of any gains payable by the CCP to non-defaulting clearing members in recovery, if applicable, and the \u2018no creditor worse off\u2019 principle. (59) With due respect for the impact on financial stability and as a last resort, resolution authorities should be able to exclude or partially exclude some contracts from position and loss allocation in a number of circumstances. Where such exclusions are applied, it should be possible to increase the level of exposure or loss applied to other contracts to take account of such exclusions subject to the \u2018no creditor worse off\u2019 principle being respected. (60) Where the resolution tools have been applied to transfer the critical functions or viable business of a CCP to a sound entity such as a private sector purchaser or bridge CCP, the residual part of the CCP should be liquidated within an appropriate time frame having regard to any need for the failing CCP to provide services or support to enable the purchaser or bridge CCP to carry out the activities or provide the services acquired by virtue of that transfer. (61) The sale of business tool should enable authorities to sell the CCP or parts of its business to one or more purchasers without the consent of shareholders. When applying the sale of business tool, authorities should make arrangements for the marketing of that CCP or part of its business in an open, transparent and non-discriminatory process, while aiming to maximise, as far as possible, the sale price. (62) Any net proceeds from the transfer of assets or liabilities of the CCP under resolution when applying the sale of business tool should benefit the entity left in the winding up proceedings. Any net proceeds from the transfer of instruments of ownership issued by the CCP under resolution when applying the sale of business tool should benefit the shareholders. Any consideration paid by the purchaser should also benefit any non-defaulting clearing members that have suffered losses. Any such net proceeds or benefit should be subject to the full recoupment of any public fund provided in resolution. Proceeds should be calculated net of the costs that have arisen from the failure of the CCP and from the resolution process. (63) In order to perform the sale of business in a timely manner and protect financial stability, the assessment of the buyer of a qualifying holding should be carried out in a timely manner that does not delay the application of the sale of business tool. The CCP, the purchaser or both, depending on the effects of the sale of business tool and the form of acquisition, should be able to exercise or maintain existing rights of membership and accessing payment and settlement systems and other linked financial market infrastructures and trading venues. Such rights should not be denied on the basis either of non-compliance with the relevant criteria for membership or participation, or of insufficient credit rating. A purchaser who does not meet those criteria can only exercise such rights for a period to be specified by the resolution authority. (64) Information concerning the marketing of a failing CCP and the negotiations with potential acquirers prior to the application of the sale-of-business tool is likely to be of systemic importance. In order to ensure financial stability, it is important that it is possible for the disclosure to the public of such information required under Regulation (EU) No 596/2014 of the European Parliament and of the Council (8) to be delayed for the time necessary to plan and structure the resolution of the CCP in accordance with delays permitted under the market abuse regime. (65) As a CCP which is wholly or partially owned by one or more public authorities or controlled by the resolution authority, a bridge CCP should have as its main purpose ensuring that essential financial services continue to be provided to the clearing members and clients of the CCP that had been placed under resolution and that essential financial activities continue to be performed. The bridge CCP should be operated as a viable going concern entity and be put back on the market when conditions are appropriate or wound up if it is no longer viable. (66) Where all other options are unavailable or demonstrably insufficient to safeguard financial stability, government participation in the shape of equity support or temporary public ownership should be possible, in accordance with applicable rules on State aid, including a restructuring of the operations of the CCP. In order to avoid moral hazard, such extraordinary public financial support should be provided only as a last resort, be temporary in nature and always be recovered over an appropriate period. Therefore, while not constituting an obstacle to applying government stabilisation tools, comprehensive and credible arrangements for the recoupment of funds should be established by Member States. The application of government stabilisation tools is without prejudice to the role of any central bank in potentially providing liquidity to the financial system, at the central bank\u2019s exclusive discretion, even in times of stress. (67) To ensure the ability of a resolution authority to apply the loss and position allocation tools to contracts with entities based in third countries, recognition of that possibility should be included in the operating rules of the CCP. (68) Resolution authorities should have all the necessary legal powers that, in different combinations, could be exercised when applying the resolution tools. They should include the power to transfer instruments of ownership, assets, rights, obligations or liabilities of a failing CCP to another entity such as another CCP or a bridge CCP, the power to write down or cancel instruments of ownership, or write down or convert liabilities of a failing CCP, the power to write down variation margin, the power to enforce any outstanding obligations of third parties in relation to the CCP, including recovery cash calls, as set out in the CCP\u2019s operating rules, and position allocations, the power to exercise resolution cash calls, the power to terminate contracts of the CCP partially and fully, the power to replace the management and the power to impose a temporary moratorium on the payment of claims. The CCP and the members of its board and senior management should remain liable, subject to national civil or criminal law, for the failure of the CCP. (69) The resolution framework should include procedural requirements to ensure that resolution actions are properly notified and made public. However, as information obtained by resolution authorities and their professional advisers during the resolution process is likely to be sensitive, before the resolution decision is made public, it should be subject to an effective confidentiality regime. The fact that information on the contents and details of recovery and resolution plans and the result of any assessment of those plans could have far-reaching effects, in particular on the undertakings concerned, must be taken into account. Any information provided in respect of a decision before it is taken, be it on whether the conditions for resolution are satisfied, on the application of a specific tool or of any action during the proceedings, must be presumed to have effects on the public and private interests concerned by the action. Information that the resolution authority is examining a specific CCP could be enough for there to be negative effects on that CCP. It is therefore necessary to ensure that there are appropriate mechanisms for maintaining the confidentiality of such information, such as the content and details of recovery and resolution plans and the result of any assessment carried out in that context. (70) Resolution authorities should have ancillary powers to ensure the effectiveness of the transfer of instruments of ownership or debt instruments and assets, liabilities, rights and obligations, including positions and related margins. Subject to the safeguards specified in this Regulation, those powers should include the power to remove the rights of third parties from the transferred instruments or assets and the power to enforce contracts and to provide for the continuity of arrangements vis-\u00e0-vis the recipient of the transferred assets and instruments of ownership. However, the rights of employees to terminate a contract of employment should not be affected. The right of a party to terminate a contract with a CCP under resolution, or a group entity thereof, for reasons other than the resolution of the failing CCP should not be affected either. Resolution authorities should have the ancillary power to require the residual CCP that is being wound up under normal insolvency proceedings to provide services that are necessary to enable the CCP to which assets, contracts or instruments of ownership have been transferred by virtue of the application of the sale of business tool or the bridge CCP tool to operate its business. (71) Given that crisis management measures could be required to be taken urgently due to serious financial stability risks in the Member State and the Union, any procedure under national law relating to the application for ex-ante judicial approval of a crisis management measure and the court\u2019s consideration of such an application should be expeditious. Given the requirement for a crisis management measure to be taken urgently, the court should give its decision within 24 hours and Member States should ensure that the relevant authority can take its decision immediately after the court\u2019s decision. This should be without prejudice to the right of interested parties to request the court to set aside the decision for a limited period after the resolution authority has taken the crisis management measure. (72) In accordance with Article 47 of the Charter, the parties concerned have the right to due process and to an effective remedy against the measures affecting them. The decisions taken by the resolution authorities should therefore be subject to the right of appeal. (73) Resolution action taken by national resolution authorities might require economic assessments and a large margin of discretion. The national resolution authorities are specifically equipped with the expertise needed for making those assessments and for determining the appropriate use of the margin of discretion. Therefore, it is important to ensure that the economic assessments made by national resolution authorities in that context are used as a basis by national courts when reviewing the crisis management measures concerned. However, the complex nature of those assessments should not prevent national courts from examining whether the evidence relied on by the resolution authority is factually accurate, reliable and consistent, whether that evidence contains all relevant information which should be taken into account in order to assess a complex situation and whether it is capable of substantiating the conclusions drawn therefrom. (74) In order to cover situations of extreme urgency and since the suspension of any decision of the resolution authorities might impede the continuity of critical functions, it is necessary to provide that the lodging of any appeal should not result in automatic suspension of the effects of the challenged decision and that the decision of the resolution authority should be immediately enforceable. (75) In addition, where necessary in order to protect third parties who have acquired assets, contracts, rights and liabilities of the CCP under resolution in good faith by virtue of the exercise of the resolution powers by the resolution authorities and to ensure the stability of the financial markets, a right of appeal should not affect any subsequent administrative act or transaction concluded on the basis of an annulled decision. In such cases, remedies for a wrongful decision should therefore be limited to the award of compensation for the damages suffered by the affected persons. (76) In the interest of efficient resolution, and in order to avoid conflicts of jurisdiction, no normal insolvency proceedings for the failing CCP should be opened or continued whilst the resolution authority is exercising its resolution powers or applying the resolution tools, except at the initiative or with the consent of the resolution authority. It is useful and necessary to suspend, for a limited period, certain contractual obligations so that the resolution authority has time to put into practice the resolution tools. However, this should not apply to obligations of a failing CCP towards systems designated under Directive 98/26/EC of the European Parliament and of the Council (9), including other CCPs and central banks. Directive 98/26/EC reduces the risk associated with participation in payment and securities settlement systems, in particular by reducing disruption in the event of the insolvency of a participant in such a system. In order to ensure that those protections apply appropriately in crisis situations, whilst maintaining appropriate certainty for operators of payment and securities settlement systems and other market participants, crisis prevention measures or resolution actions should not be deemed to be insolvency proceedings within the meaning of Directive 98/26/EC, provided that the substantive obligations under the contract continue to be performed. However, the operation of a system designated under or the right to collateral security guaranteed by, Directive 98/26/EC should not be undermined. (77) In order to ensure that resolution authorities, when transferring assets and liabilities to a private sector purchaser or bridge CCP, have an adequate period to identify contracts that need to be transferred, it might be appropriate to impose proportionate restrictions on the rights of counterparties to close out, accelerate or otherwise terminate financial contracts before the transfer is made. Such a restriction would be necessary to allow authorities to obtain a true picture of the balance sheet of the failing CCP, without the changes in value and scope that extensive exercise of termination rights would entail. In order to interfere with the contractual rights of counterparties to the minimum extent necessary, the restriction on termination rights should be limited to the shortest period possible and apply only in relation to the crisis prevention measure or resolution action, including the occurrence of any event directly linked to the application of such a measure, and the rights to terminate arising from any other default, including failure to pay or deliver margins, should remain. (78) In order to preserve legitimate capital market arrangements in the event of a transfer of some, but not all, of the assets, contracts, rights and liabilities of a failing CCP, it is appropriate to include safeguards to prevent, as appropriate, the splitting of linked liabilities, rights and contracts. Such a restriction on selected practices in relation to linked contracts and related collateral should extend to contracts with the same counterparty covered by security arrangements, title transfer financial collateral arrangements, set-off arrangements, close out netting arrangements, and structured finance arrangements. Where the safeguard applies, resolution authorities should seek to transfer all linked contracts within a protected arrangement, or leave them all with the residual failing CCP. Those safeguards should ensure that the regulatory capital treatment of exposures covered by a netting arrangement for the purposes of Directive 2013/36/EU of the European Parliament and of the Council (10) is affected to a minimum degree. (79) Union CCPs provide services to clearing members and their clients located in third countries and third-country CCPs provide services to clearing members and their clients located in the Union. Effective resolution of internationally active CCPs requires cooperation between Member States and third-country authorities. For that purpose ESMA should provide guidance on the relevant content of cooperation arrangements to be concluded with authorities of third countries. Those cooperation arrangements should ensure effective planning, decision-making and coordination in respect of internationally active CCPs. National resolution authorities should recognise and enforce third-country resolution proceedings in certain circumstances. Cooperation should also take place with regard to subsidiaries of Union or third-country CCPs and their clearing members and their clients. (80) In order to ensure the consistent application of administrative penalties across Member States for breaches of this Regulation, this Regulation should provide for a list of key administrative penalties and other administrative measures that need to be available to the resolution authorities and the competent authorities, for the power to impose those administrative penalties and other administrative measures on all persons, whether legal or natural, responsible for an infringement, and for a list of key criteria when determining the level and type of those administrative penalties and other administrative measures and for levels of administrative pecuniary penalties. Administrative penalties and other administrative measures should take into account factors such as any identified financial benefit resulting from the infringement, the gravity and duration of the infringement, any aggravating or mitigating factors, the need for administrative fines to have a deterrent effect and, where appropriate, include a discount for cooperation with the resolution authority or the competent authority. The adoption and publication of administrative penalties should respect fundamental rights as laid down in the Charter. (81) In order to ensure consistent harmonisation and adequate protection for market participants across the Union, the Commission should be empowered to adopt draft regulatory technical standards developed by ESMA by means of delegated acts pursuant to Article 290 of the Treaty on the Functioning of the European Union (TFEU), in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010 to specify the following elements: (a) the content of the written arrangements and procedures for the functioning of the resolution colleges; (b) the methodology for calculation and maintenance of the amount of the additional pre-funded dedicated own resources to be used by the CCP in recovery and the procedures, where such own resources are not available, for the CCP to resort to recovery measures that require contributions of non-defaulting clearing members and to subsequently reimburse such clearing members; (c) the assessment methodology for recovery plans; (d) the contents of resolution plans; (e) the order of allocation, maximum period and maximum share of the CCP\u2019s annual profits under the recompense mechanism in recovery; (f) elements relevant to the conduct of valuations; (g) methodology for calculating the buffer for additional losses to be included in provisional valuations; (h) the minimum elements that should be included in a business reorganisation plan; (i) criteria that a business reorganisation plan is to fulfil; (j) the methodology for final valuation under the \u2018no credit worse off\u2019 principle; (k) the conditions for clearing members to pass on compensation to their clients in line with the contractual symmetry principle and the conditions under which it is to be considered proportionate. (82) The Commission should be able to suspend any clearing obligation established pursuant to Article 5 of Regulation (EU) No 648/2012, following a request from the resolution authority of a CCP under resolution or its competent authority, on their own initiative or at the request of the competent authority responsible for the supervision of a clearing member of the CCP under resolution, and following a non-binding opinion by ESMA, for a specific type of counterparty or for specific classes of OTC derivatives which are cleared by a CCP under resolution. The decision to suspend the clearing obligation should be adopted only if it is necessary to preserve financial stability and market confidence, in particular to avoid contagion effects and to prevent counterparties and investors having high and uncertain risk exposures to a CCP. In order to adopt its decision, the Commission should take into account the resolution objectives, the criteria stated in Regulation (EU) No 648/2012 for subjecting OTC derivatives to the clearing obligation regarding those OTC derivatives for which the suspension is requested and whether it is necessary to suspend the clearing obligation in order to preserve financial stability and the orderly functioning of financial markets in the Union. ESMA should be able to request the Commission to suspend the trading obligation laid down in Regulation (EU) No 600/2014 of the European Parliament and of the Council (11) where it considers the suspension of the clearing obligation to be a material change in the criteria for the trading obligation. The suspension should be of a temporary nature with a possibility of extension. Likewise, the role of the CCP\u2019s risk committee, as set out in Article 28 of Regulation (EU) No 648/2012, should be enhanced to further encourage the CCP to manage its risks prudently and improve its resilience. Members of the risk committee should be able to inform the competent authority when the CCP does not follow the risk committee\u2019s advice, and representatives of clearing members and clients on the risk committee should be able to use information provided to monitor their exposures to the CCP, in accordance with confidentiality safeguards and without prejudice to the limitations to the exchange of such information laid out in competition law. Finally, resolution authorities of CCPs should also have access to all necessary information in trade repositories. Regulation (EU) No 648/2012 and Regulation (EU) 2015/2365 of the European Parliament and of the Council (12) should therefore be amended accordingly. (83) In order to ensure the proper implementation of the interest rate benchmark reform of the FSB it is necessary to provide clarity to market participants that transactions entered into or novated before the entry into application of the clearing or margin requirements to OTC derivative transactions referencing an interest rate benchmark (legacy trades) will not be subject to the requirements as provided for in Regulation (EU) No 648/2012 when they are novated for the sole purpose of implementing or preparing for the implementation of the interest rate benchmark reform. Doing so should also prevent any risk that Union counterparties to those legacy trades find themselves unprepared when a specific benchmark is materially changed or discontinued, therefore alleviating related financial stability concerns. Such approach is in line with the international guidance from the Basel Committee on Banking Supervision (BCBS) and the International Organization of Securities Commissions (IOSCO). (84) In order to implement resolution of CCPs effectively, the safeguards provided for in Directive 2002/47/EC of the European Parliament and of the Council (13) should not apply to any restriction on the enforcement of a financial collateral arrangement or on the effect of a security financial collateral arrangement, any close-out netting or set-off provision provided for in this Regulation. (85) Directives (EU) 2017/1132 (14), 2004/25/EC (15) and 2007/36/EC (16) of the European Parliament and of the Council contain rules on the protection of shareholders and creditors of CCPs that fall within the scope of those Directives. In a situation where resolution authorities need to act rapidly under this Regulation, those rules might hinder effective resolution action and application of resolution tools and powers by resolution authorities. Derogations under Directive 2014/59/EU should therefore be extended to actions taken pursuant to this Regulation. In order to guarantee the maximum degree of legal certainty for stakeholders, the derogations should be clearly and narrowly defined, and should only be used in the public interest and when resolution triggers are met. (86) In order to avoid duplication of requirements, Directive 2014/59/EU and Regulation (EU) No 806/2014 of the European Parliament and of the Council (17) should be amended to exclude from their scope those entities that are also authorised in accordance with Regulation (EU) No 648/2012. (87) Article 54(2) of Regulation (EU) No 600/2014 provides for a transitional period during which Article 35 or 36 of that Regulation would not apply to those CCPs or trading venues which applied to their competent authority to benefit from the transitional arrangements, in respect of exchange-traded derivatives. The transitional period during which a trading venue or a CCP can be exempted by its national competent authority, in respect of exchange-traded derivatives from the application of Articles 35 and 36 of that Regulation expired on 3 July 2020. The current market environment, with a high degree of uncertainty and volatility driven by the COVID-19 pandemic, negatively impacts CCPs and trading venues\u2019 operations by increasing their operational risks. Those increased risks, combined with limited capacity for assessing access requests and for managing the migration of transactions flows, might impact the orderly functioning of markets or financial stability. In addition, that Regulation provides for a novel exchange-traded derivatives regime on access to critical market infrastructures which aims to balance more competition amongst those infrastructures with the need to preserve their operational integrity. Therefore, while that Regulation seeks to create a competitive market for financial infrastructures, economic operators should not expect that existing rules and priorities are maintained when economic circumstances change as a consequence, in particular, of a major economic crisis. This is particularly the case in an area where the interaction between critical market infrastructures, such as trading and clearing infrastructures, requires an exceptional level of operational resilience, as any failures in such critical infrastructures would pose a high risk to financial stability. As a consequence of the COVID-19 pandemic, the application date of the new open access regime for trading venues and CCPs offering trading and clearing services in relation to exchange-traded derivatives is postponed by one year, until 3 July 2021. (88) In order to ensure that resolution authorities of CCPs are represented in all relevant fora, and to ensure that ESMA benefits from all expertise necessary to carry out the tasks related to the recovery and resolution of CCPs, Regulation (EU) No 1095/2010 should be amended in order to include national CCP resolution authorities in the concept of competent authorities established by that Regulation. (89) In order to prepare the decisions of ESMA in relation to the tasks allocated to it involving the development of draft technical standards on ex-ante and ex-post valuations and on resolution colleges and resolution plans, and of guidelines on the conditions for resolution, and on binding mediation, and to ensure the comprehensive involvement of the European Supervisory Authority (European Banking Authority) (EBA) and its members in the preparation of those decisions, ESMA should create an internal committee (the \u2018ESMA Resolution Committee\u2019) with resolution authorities as members. Where relevant, competent authorities defined in Regulation (EU) No 575/2013 of the European Parliament and of the Council (18), including the European Central Bank, and resolution authorities as defined in Directive 2014/59/EU, including the Single Resolution Board established by Regulation (EU) No 806/2014, should be invited to participate as observers. (90) The ESMA Resolution Committee should be consulted in the preparation of the conceptual framework for the assessments of the resilience of CCPs to adverse market developments, when this assessment includes the aggregate effect of CCP recovery and resolution arrangements on Union financial stability. In such cases, the ESMA Resolution Committee should also be consulted when the findings of such stress tests are being assessed. (91) This Regulation respects the fundamental rights and observes the rights, freedoms and principles recognised by the Charter. (92) When taking decisions or actions under this Regulation, competent authorities and resolution authorities should always have due regard to the impact of their decisions and actions on financial stability in other Member States and on the economic situation in other Member States where the CCP\u2019s operations are critical or important for local financial markets, including where clearing members and, where relevant information is available, their clients are located and where linked trading venues and financial market infrastructures, including interoperable CCPs, are established. (93) Since the objective of this Regulation, namely the harmonisation of the rules and processes for the recovery and resolution of CCPs, cannot be sufficiently achieved by the Member States, but can rather, by reason of the effects of a failure of any CCPs in the whole Union, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (94) The application of this Regulation should be deferred until 12 August 2022 to establish all essential implementing measures and to allow CCPs and other market participants to take the necessary steps for compliance purposes. However, the requirement for the CCP to use dedicated own resources in recovery and the provisions to recompense clearing members in the extraordinary case of applying variation margin gains haircutting in recovery, rely on the appropriate regulatory technical standards to be in place. It is therefore appropriate to extend the deferral of the date of application for such provision until 12 February 2023. Additionally, certain provisions that apply to CCP recovery plans and the adoption and review of recovery plans, including the obligation to submit a recovery plan, should be applied from an earlier date, since all CCPs already have recovery plans, as required by the Principles for Financial Market Infrastructures published by the Committee on Payments and Market Infrastructures and the IOSCO. CCPs already authorised under Regulation (EU) No 648/2012 should take the appropriate steps to ensure that they will be able to submit their recovery plans to their competent authorities at the latest on 12 February 2022. Those provisions related to recovery plans should be applied from 12 February 2022. If the resolution authority had not been consulted on the recovery plan of the CCP, once the other provisions of this Regulation become applicable, the competent authority of the CCP should consult the resolution authority on the CCP\u2019s recovery plan without delay. In order to ensure legal certainty for counterparties, the amendments to Regulation (EU) No 648/2012 intended to ensure the proper implementation of the FSB\u2019s interest rate benchmark reform should apply from the date of entry into force of this Regulation. (95) In order to ensure that increased operational risks stemming from the application of the open access regime for exchange-traded derivatives do not endanger the orderly functioning of markets or financial stability and to avoid any discontinuity, it is necessary to retroactively apply the extension of such transitional periods from 4 July 2020 until 3 July 2021. (96) This Regulation should ensure that CCPs have sufficient loss-absorbing and recapitalisation capacity to ensure smooth and fast absorption of losses and recapitalisation with a minimum impact on financial stability while aiming to avoid an impact on taxpayers. Consistently with the internationally agreed principles for effective resolution regimes for financial institutions developed by the FSB, this Regulation should ensure that equity holders of a CCP absorb losses first in resolution in a way that minimises the risk of legal challenge by equity holders, on the basis that their losses in resolution are greater than the losses that they would have incurred under normal insolvency proceedings according to the \u2018no creditor worse off\u2019 principle. On 15 November 2018, the FSB published a consultation paper entitled \u2018Financial resources to support CCP resolution and the treatment of CCP equity in resolution\u2019. Based on the feedback received to that paper and further assessments, the FSB plans to issue guidance at the end of 2020 on how equity should be used in the event of resolution of CCPs in a manner that minimises the risk of legal challenge by equity holders resulting from the application of the \u2018no creditor worse off\u2019 principle. Following the publication of that guidance, the Commission should review the application of the rules laid down in this Regulation with regard to the write-down of equity in resolution by taking into account those internationally agreed standards. In addition to this specific review, the Commission should review the application of this Regulation after five years from the date of its entry into force, inter alia, by taking into account any further international developments. That general review should cover at least certain core matters related to the recovery and resolution of CCPs, such as financial resources available to resolution authorities to cover non-default losses and the CCPs\u2019 own resources to be used in recovery and resolution, HAVE ADOPTED THIS REGULATION: TITLE I SUBJECT MATTER AND DEFINITIONS Article 1 Subject matter This Regulation lays down rules and procedures relating to the recovery and resolution of central counterparties (CCPs) authorised in accordance with Regulation (EU) No 648/2012 and rules relating to arrangements with third countries in the field of recovery and resolution of CCPs. Article 2 Definitions For the purposes of this Regulation the following definitions apply: (1) \u2018CCP\u2019 means a CCP as defined in point (1) of Article 2 of Regulation (EU) No 648/2012; (2) \u2018resolution college\u2019 means the college established pursuant to Article 4; (3) \u2018resolution authority\u2019 means an authority designated by a Member State in accordance with Article 3; (4) \u2018resolution tool\u2019 means a resolution tool as set out in Article 27(1); (5) \u2018resolution power\u2019 means any of the powers laid down in Articles 48 to 58; (6) \u2018resolution objectives\u2019 mean the resolution objectives laid down in Article 21; (7) \u2018competent authority\u2019 means an authority designated by a Member State in accordance with Article 22 of Regulation (EU) No 648/2012; (8) \u2018default event\u2019 means a scenario in which the CCP has declared in default: (a) one or more clearing members in accordance with the procedure set out in Article 48 of Regulation (EU) No 648/2012; or (b) one or more interoperable CCPs in accordance with the relevant contractual arrangements or with the procedure set out in Article 52 of Regulation (EU) No 648/2012; (9) \u2018non-default event\u2019 means a scenario in which losses are incurred by a CCP for any reason other than a default event, including but not limited to, business, custody, investment, legal or operational failures or fraud, including failures resulting from cyber-attacks; (10) \u2018resolution plan\u2019 means a resolution plan for a CCP drawn up in accordance with Article 12; (11) \u2018resolution action\u2019 means a decision to place a CCP under resolution pursuant to Article 22, the application of a resolution tool, or the exercise of one or more resolution powers; (12) \u2018clearing member\u2019 means a clearing member as defined in point 14 of Article 2 of Regulation (EU) No 648/2012; (13) \u2018parent undertaking\u2019 means a parent undertaking as defined in point (15)(a) of Article 4(1) of Regulation (EU) No 575/2013; (14) \u2018third-country CCP\u2019 means a CCP the head office of which is established in a third country; (15) \u2018set-off arrangement\u2019 means an arrangement under which two or more claims or obligations owed between the CCP under resolution and a counterparty can be set off against each other; (16) \u2018financial market infrastructure\u2019 or \u2018FMI\u2019 means a CCP, a central securities depository, a trade repository, a payment system or another system defined and designated by a Member State under point (a) of Article 2 of Directive 98/26/EC; (17) \u2018trading venue\u2019 means a trading venue as defined in point 4 of Article 2 of Regulation (EU) No 648/2012; (18) \u2018client\u2019 means a client as defined in point 15 of Article 2 of Regulation (EU) No 648/2012; (19) \u2018O-SIIs\u2019 means other systemically important institutions as referred to in Article 131(3) of Directive 2013/36/EU; (20) \u2018indirect client\u2019 means an undertaking which has established indirect clearing arrangements with a clearing member within the meaning of the second subparagraph of Article 4(3) of Regulation (EU) No 648/2012; (21) \u2018interoperable CCP\u2019 means a CCP with which an interoperability arrangement has been established; (22) \u2018recovery plan\u2019 means a recovery plan drawn up and maintained by a CCP in accordance with Article 9; (23) \u2018board\u2019 means the administrative or supervisory board, or both, set up pursuant to national company law and in accordance with Article 27(2) of Regulation (EU) No 648/2012; (24) \u2018supervisory college\u2019 means the college referred to in Article 18(1) of Regulation (EU) No 648/2012; (25) \u2018capital\u2019 means capital as defined in point 25 of Article 2 of Regulation (EU) No 648/2012; (26) \u2018default waterfall\u2019 means default waterfall in accordance with Article 45 of Regulation (EU) No 648/2012; (27) \u2018critical functions\u2019 means activities, services or operations provided to third parties external to the CCP the discontinuance of which is likely to lead to the disruption of services that are essential to the real economy or to disrupt financial stability in one or more Member States due to the size, market share, external and internal interconnectedness, complexity or cross-border activities of a CCP, with particular regard to the substitutability of those activities, services or operations; (28) \u2018group\u2019 means a group as defined in point 16 of Article 2 of Regulation (EU) No 648/2012; (29) \u2018linked FMI\u2019 means an FMI with which the CCP has entered into contractual arrangements, including interoperability arrangements; (30) \u2018extraordinary public financial support\u2019 means State aid within the meaning of Article 107(1) of the Treaty on the Functioning of the European Union (TFEU), or any other public financial support at supra-national level, which, if provided for at national level, would constitute State aid, that is provided in order to preserve or restore the viability, liquidity or solvency of a CCP; (31) \u2018financial contracts\u2019 means contracts and agreements as defined in point 100 of Article 2(1) of Directive 2014/59/EU; (32) \u2018normal insolvency proceedings\u2019 means collective insolvency proceedings which entail the partial or total divestment of a debtor and the appointment of a liquidator or an administrator normally applicable to CCPs under national law and either specific to those institutions or generally applicable to any natural or legal person; (33) \u2018instruments of ownership\u2019 means shares, other instruments that confer ownership, instruments that are convertible into or give the right to acquire shares or other instruments of ownership, and instruments representing interests in shares or other instruments of ownership; (34) \u2018designated national macroprudential authority\u2019 means the authority entrusted with the conduct of macroprudential policy referred to in Recommendation B1 of the Recommendation of the European Systemic Risk Board (ESRB) of 22 December 2011 on the macroprudential mandate of national authorities (ESRB/2011/3); (35) \u2018default fund\u2019 means a default fund maintained by a CCP in accordance with Article 42 of Regulation (EU) No 648/2012; (36) \u2018pre-funded resources\u2019 means resources which are held by and freely available to the relevant legal person; (37) \u2018senior management\u2019 means the person or persons who effectively direct the business of the CCP, and the executive member or members of the board; (38) \u2018trade repository\u2019 means a trade repository as defined in point 2 of Article 2 of Regulation (EU) No 648/2012 or in point 1 of Article 3 of Regulation (EU) 2015/2365 of the European Parliament and of the Council (19); (39) \u2018Union State aid framework\u2019 means the framework established by Articles 107, 108 and 109 TFEU and regulations and all Union acts, including guidelines, communications and notices, made or adopted pursuant to Article 108(4) or Article 109 TFEU; (40) \u2018debt instruments\u2019 means bonds or other forms of unsecured transferable debt, instruments creating or acknowledging a debt, and instruments giving rights to acquire debt instruments; (41) \u2018initial margin\u2019 means margins collected by the CCP to cover potential future exposure to clearing members providing the margin and, where relevant, interoperable CCPs in the interval between the last margin collection and the liquidation of positions following a default of a clearing member or of an interoperable CCP; (42) \u2018variation margin\u2019 means margins collected or paid out to reflect current exposures resulting from actual changes in market prices; (43) \u2018resolution cash call\u2019 means a request for cash resources to be provided by clearing members to the CCP, additional to pre-funded resources, based on statutory powers available to a resolution authority in accordance with Article 31; (44) \u2018recovery cash call\u2019 means a request for cash resources, other than a resolution cash call, to be provided by clearing members to the CCP, additional to pre-funded resources, based on contractual arrangements laid out in the operating rules of the CCP; (45) \u2018transfer powers\u2019 means the powers specified in point (c) and (d) of Article 48(1) to transfer shares, other instruments of ownership, debt instruments, assets, rights, obligations or liabilities, or any combination of those items from a CCP under resolution to a recipient; (46) \u2018derivative\u2019 means a derivative as defined in point 5 of Article 2 of Regulation (EU) No 648/2012; (47) \u2018netting arrangement\u2019 means an arrangement under which a number of claims or obligations can be converted into a single net claim, including a close-out netting arrangement under which, on the occurrence of an enforcement event (however or wherever defined), the obligations of the parties are accelerated so as to become immediately due or are terminated, and in either case are converted into or replaced by a single net claim, including a close-out netting provision as defined in point (n)(i) of Article 2(1) of Directive 2002/47/EC of the European Parliament and of the Council (20) and netting as defined in point (k) of Article 2 of Directive 98/26/EC; (48) \u2018crisis prevention measure\u2019 means the exercise of powers to require a CCP to take measures to remedy deficiencies in its recovery plan under Article 10(8) and (9), the exercise of powers to address or remove impediments to resolvability under Article 16, or the application of an early intervention measure under Article 18; (49) \u2018termination right\u2019 means a right to terminate a contract, a right to accelerate, close out, set-off or net obligations or any similar provision that suspends, modifies or extinguishes an obligation of a party to the contract or a provision that prevents an obligation under the contract from arising that would otherwise arise; (50) \u2018title transfer financial collateral arrangement\u2019 means a title transfer financial collateral arrangement as defined in point (b) of Article 2(1) of Directive 2002/47/EC; (51) \u2018covered bond\u2019 means a covered bond as defined in point (1) of Article 3 of Directive (EU) 2019/2162 of the European Parliament and of the Council (21); (52) \u2018third-country resolution proceedings\u2019 means an action under the law of a third country to manage the failure of a third-country CCP that is comparable, in terms of objectives and anticipated results, to resolution actions under this Regulation; (53) \u2018relevant national authorities\u2019 means the resolution authorities, competent authorities or competent ministries designated in accordance with this Regulation or pursuant to Article 3 of Directive 2014/59/EU or other authorities in Member States with powers in relation to assets, rights, obligations or liabilities of third-country CCPs providing clearing services in their jurisdiction; (54) \u2018relevant third-country authority\u2019 means a third-country authority responsible for carrying out functions comparable to those of resolution authorities or competent authorities pursuant to this Regulation. TITLE II AUTHORITIES, RESOLUTION COLLEGE AND PROCEDURES Section 1 Resolution authorities, resolution colleges and involvement of European Supervisory Authorities Article 3 Designation of resolution authorities and competent ministries 1. Each Member State shall designate one or more resolution authorities that are empowered to apply the resolution tools and exercise the resolution powers as set out in this Regulation. Resolution authorities shall be national central banks, competent ministries, public administrative authorities or other authorities entrusted with public administrative powers. 2. Resolution authorities shall have the expertise, resources and operational capacity to apply resolution measures and exercise their powers with the speed and flexibility that are necessary to achieve the resolution objectives. 3. Where a resolution authority designated pursuant to paragraph 1 of this Article is entrusted with other functions, adequate structural arrangements shall be in place to avoid conflicts of interest between the functions entrusted to the resolution authority pursuant to this Regulation and all other functions entrusted to that authority. In particular, arrangements shall be put in place to ensure effective operational independence, including separate staff, reporting lines and decision making process of that resolution authority, from any tasks that the resolution authority may perform pursuant to Article 22 of Regulation (EU) No 648/2012 as a competent authority of the CCP and from the tasks that the resolution authority may perform as the competent authority of the clearing members referred to in point (c) of Article 18(2) of Regulation (EU) No 648/2012. 4. The requirements expressed in paragraph 3 shall not preclude that reporting lines converge at the highest level of an organisation that subsumes different functions or authorities, or that, staff may, under predefined conditions, be shared between the other functions entrusted to the resolution authority to meet temporarily high workloads, or for the resolution authority to be able to avail itself of the expertise of shared staff. 5. Authorities exercising supervision and resolution functions under Regulation (EU) No 648/2012 and this Regulation, and persons exercising those functions on their behalf, shall cooperate closely in the preparation, planning and application of resolution decisions, both where the resolution authority and the competent authority are separate entities and where the functions are carried out by the same entity. 6. Resolution authorities shall adopt and make public the internal rules they have in place to ensure compliance with the requirements set out in paragraph 3, including rules regarding professional secrecy and information exchanges between the different functional areas. 7. Member States where no CCP has been established may derogate from the requirements set out in paragraph 3, except with regards to arrangements to avoid conflicts of interest. 8. Each Member State shall designate a single ministry which shall be responsible for exercising the functions entrusted to the competent ministry pursuant to this Regulation. 9. Where the resolution authority in a Member State is not the competent ministry, the resolution authority shall inform the competent ministry without undue delay of the decisions taken pursuant to this Regulation and, unless otherwise laid down in national law, obtain its approval before implementing decisions that will have a direct fiscal impact or systemic implications that are likely to lead to a direct fiscal impact. 10. Member States shall notify the Commission and the European Supervisory Authority (European Securities and Markets Authority) (ESMA), established by Regulation (EU) No 1095/2010, of the resolution authorities designated pursuant to paragraph 1. 11. Where a Member State designates more than one resolution authority pursuant to paragraph 1, the notification referred to in paragraph 10 shall include the following: (a) the reasons justifying that multiple designation; (b) the allocation of functions and responsibilities between those authorities; (c) the way in which coordination between them is ensured; and (d) the resolution authority designated as the contact authority for the purposes of cooperation and coordination with the relevant authorities of other Member States. 12. ESMA shall publish a list of the resolution authorities and the contact authorities notified pursuant to paragraph 10. Article 4 Resolution colleges 1. The resolution authority of the CCP shall establish, manage and chair a resolution college to carry out the tasks referred to in Articles 12, 15 and 16, and ensure cooperation and coordination with the authorities that are members of the resolution college and, where appropriate, cooperation with third-country competent authorities and resolution authorities. Resolution colleges shall provide a framework for resolution authorities and other relevant authorities to perform the following tasks: (a) exchange information relevant for drawing up resolution plans, including for taking into consideration the systemic impact of the implementation of the resolution plan, for the application of preparatory and preventative measures and for resolution; (b) draw up resolution plans pursuant to Article 12; (c) assess the resolvability of CCPs pursuant to Article 15; (d) identify, address and remove impediments to the resolvability of CCPs pursuant to Article 16; and (e) coordinate public communication about resolution plans and strategies. 2. The following shall be members of the resolution college: (a) the resolution authority of the CCP; (b) the competent authority of the CCP; (c) the competent authorities and the resolution authorities of the clearing members referred to in point (c) of Article 18(2) of Regulation (EU) No 648/2012, including, where relevant, the European Central Bank (ECB) in the framework of the tasks concerning the prudential supervision of credit institutions within the single supervisory mechanism conferred upon it in accordance with Council Regulation (EU) No 1024/2013 (22) and the Single Resolution Board (SRB) in its role as a resolution authority of credit institutions within the single resolution mechanism conferred upon it in accordance with Regulation (EU) No 806/2014; (d) the competent authorities and the resolution authorities of clearing members, other than those referred to in point (c). Those competent authorities and resolution authorities shall inform the resolution authority of the CCP and justify their participation in the college based on their assessment of the impact that the CCP\u2019s resolution could have on the financial stability of their respective Member State; (e) the competent authorities or the resolution authorities of clearing members\u2019 clients, provided that the college does not already have a member from their own Member State in accordance with points (c), (d), (f), (g) or (h). Those authorities shall inform the resolution authority of the CCP and justify their participation in the college based on their assessment of the impact that the CCP\u2019s resolution could have on the financial stability of their respective Member State; (f) the competent authorities referred to in point (d) of Article 18(2) of Regulation (EU) No 648/2012; (g) the competent authorities and the resolution authorities of the CCPs referred to in point (e) of Article 18(2) of Regulation (EU) No 648/2012; (h) the competent authorities referred to in point (f) of Article 18(2) of Regulation (EU) No 648/2012; (i) the members of the European System of Central Banks (ESCB) referred to in point (g) of Article 18(2) of Regulation (EU) No 648/2012; (j) the central banks of issue referred to in point (h) of Article 18(2) of Regulation (EU) No 648/2012; (k) the central banks of issue of the Union currencies of the financial instruments cleared by the CCP, other than those referred to in point (j). Those central banks of issue shall inform the resolution authority of the CCP and justify their participation in the college based on their assessment of the impact that the CCP\u2019s resolution could have on their respective currency of issue; (l) the competent authority of the parent undertaking, where applicable; (m) the competent ministry, where the resolution authority referred to in point (a) is not the competent ministry; (n) ESMA; and (o) the European Supervisory Authority (European Banking Authority) (EBA), established by Regulation (EU) No 1093/2010. 3. ESMA, EBA and the authorities referred to in points (d), (e), (k) and (l) of paragraph 2 shall not have voting rights in resolution colleges. Where the ECB is a member of the college pursuant to points (c) and (j) of paragraph 2, it shall have two votes in the college. 4. The competent authorities and resolution authorities of clearing members established in third countries and the competent authorities and resolution authorities of third-country CCPs with which the CCP has established interoperability arrangements may be invited to participate in the resolution college as observers. Their attendance shall be conditional on those authorities being subject to confidentiality requirements equivalent, in the opinion of the resolution authority of the CCP as the chair of the resolution college, to those laid down in Article 73. The participation of third-country authorities in the resolution college may be limited to the discussion of select cross-border enforcement issues, which may include the following: (a) effective and coordinated enforcement of resolution actions, in particular in accordance with Articles 53 and 77; (b) identification and removal of possible impediments to effective resolution action that may stem from divergent laws governing collateral, netting and set-off arrangements and different recovery and resolution powers or strategies; (c) identification and coordination of any need for new licensing, recognition or authorisation requirements, considering the need for resolution actions to be carried out in a timely fashion; (d) possible suspension of any clearing obligation for the relevant asset classes affected by the resolution of the CCP pursuant to Article 6a of Regulation (EU) No 648/2012 or to any equivalent provision under the national law of the third country concerned; (e) possible influence of different time-zones on the applicable close of business hours regarding the end of trading. 5. The resolution authority of the CCP as the chair of the resolution college shall be responsible for the following tasks: (a) establishing written arrangements and procedures for the functioning of the resolution college, after consulting the other members of the resolution college; (b) coordinating all activities of the resolution college; (c) convening and chairing all meetings of the resolution college; (d) keeping all members of the resolution college fully informed in advance of the organisation of meetings, of the main issues to be discussed in those meetings and of the items to be considered for the purposes of those discussions; (e) deciding whether and which third-country authorities are invited to attend particular meetings of the resolution college in accordance with paragraph 4; (f) enabling, promoting and coordinating the timely exchange of all relevant information between members of the resolution college; and (g) keeping all members of the resolution college informed, in a timely manner, of the decisions and outcomes of those meetings. 6. In order to facilitate the performance of the tasks assigned to the college, members of the college referred to in paragraph 2 shall be entitled to contribute to the setting of the agenda of the college meetings, in particular by adding points to the agenda of the meeting. 7. In order to ensure the consistent and coherent functioning of resolution colleges across the Union, ESMA shall develop draft regulatory technical standards in order to specify the content of the written arrangements and procedures for the functioning of the resolution colleges referred to in paragraph 1. For the purposes of preparing those regulatory standards, ESMA shall take into account the relevant provisions of the delegated acts adopted on the basis of Article 88(7) of Directive 2014/59/EU. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 5 ESMA Resolution Committee 1. ESMA shall create a resolution committee (the \u2018ESMA Resolution Committee\u2019) pursuant to Article 41 of Regulation (EU) No 1095/2010 for the purpose of preparing the decisions entrusted to ESMA in this Regulation, except for the decisions to be adopted pursuant to Article 11 of this Regulation. The ESMA Resolution Committee shall also promote the drawing up and coordination of resolution plans and develop methods for the resolution of failing CCPs. 2. The ESMA Resolution Committee shall be composed of the authorities designated pursuant to Article 3(1). Authorities referred to in points (i) and (v) of Article 4(2) of Regulation (EU) No 1093/2010 shall be invited to participate in the ESMA Resolution Committee as observers. 3. For the purposes of this Regulation, ESMA shall cooperate with the European Supervisory Authority (European Insurance and Occupational Pensions Authority) (EIOPA) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (23) and EBA within the framework of the Joint Committee of the European Supervisory Authorities established under Article 54 of Regulation (EU) No 1093/2010, Article 54 of Regulation (EU) No 1094/2010 and Article 54 of Regulation (EU) No 1095/2010. 4. For the purposes of this Regulation, ESMA shall ensure structural separation between the ESMA Resolution Committee and other functions referred to in Regulation (EU) No 1095/2010. Article 6 Cooperation between authorities 1. Competent authorities, resolution authorities and ESMA shall cooperate closely for the purposes of this Regulation. In particular, during the recovery phase, the competent authority and the members of the supervisory college should cooperate and communicate effectively with the resolution authority, to enable the resolution authority to act in a timely manner. 2. The resolution authority of a CCP and the resolution authorities of its clearing members shall cooperate closely with the aim of ensuring that there are no impediments to resolution. 3. Competent authorities and resolution authorities shall cooperate with ESMA for the purposes of this Regulation in accordance with Regulation (EU) No 1095/2010. Competent authorities and resolution authorities shall, without delay, provide ESMA with all the information necessary to carry out its duties in accordance with Article 35 of Regulation (EU) No 1095/2010. Section 2 Decision-making and procedures Article 7 General principles regarding decision-making Competent authorities, resolution authorities and ESMA shall take account of all the following principles and aspects when making decisions and taking action pursuant to this Regulation: (a) the effectiveness and proportionality of any decision or action in relation to an individual CCP are ensured, taking into account at least the following factors: (i) the CCP\u2019s legal form, ownership and organisational structure, including, where applicable, any interdependencies within the group to which the CCP belongs; (ii) the nature, size and complexity of the CCP\u2019s business, in particular the size, structure and liquidity in stressed conditions of the markets it serves; (iii) the structure, nature and diversity of the CCP\u2019s clearing membership, as well as, to the extent the information is available, of its clearing members\u2019 network of clients and indirect clients; (iv) the substitutability of the CCP\u2019s critical functions in the markets it serves; (v) the CCP\u2019s interconnectedness with other FMIs, trading venues, financial institutions and with the financial system in general; (vi) whether the CCP clears any OTC derivative contract pertaining to a class of OTC derivatives that has been declared subject to the clearing obligation in accordance with Article 5(2) of Regulation (EU) No 648/2012; and (vii) the actual or potential consequences of the infringements referred to in Articles 18(1) and 22(2). (b) the imperatives of efficacy, of timeliness, of due urgency of decision-making, when required, and of keeping costs as low as possible are observed when decisions are made and action is taken, while at the same time ensuring that market disruption is mitigated to the greatest extent possible; (c) the use of extraordinary public financial support is avoided to the greatest extent possible, such support is available and used only as a last resort and in accordance with the conditions laid out in Article 45, and no expectation of public financial support is created; (d) resolution authorities, competent authorities and other authorities cooperate with each other to ensure that decisions are made and action is taken in a coordinated and efficient manner; (e) the roles and responsibilities of relevant authorities within each Member State are defined clearly; (f) the interests of the Member States where the CCP provides services and where its clearing members, and to the extent the information is available, their clients and indirect clients, including where those clients or indirect clients are designated by Member States as O-SIIs, and any linked FMIs, including interoperable CCPs, are established, and in particular the impact of any decision or action or inaction on the financial stability or fiscal resources of those Member States and the Union as a whole; (g) resolution authorities and resolution colleges cannot require Member States to provide extraordinary public financial support, nor impinge on the budgetary sovereignty and fiscal responsibilities of Member States; (h) the interests of affected clearing members, and to the extent the information is available, their clients and indirect clients, creditors and other stakeholders of the CCP in the Member States involved need to be balanced by avoiding unfairly prejudicing or unfairly protecting the interests of particular actors and avoiding unfair burden allocation within and across Member States; (i) any obligation under this Regulation to consult an authority before any decision or action is taken implies at least an obligation to consult on those elements of the proposed decision or action which have or which are likely to have an effect on the clearing members, clients, linked FMIs or trading venues or an impact on the financial stability of the Member State where the clearing members, clients, linked FMIs or trading venues are established or located; (j) where an authority raises an issue concerning the financial stability of its Member State, the resolution authority and the resolution college of the CCP consider it thoroughly and if they do not take the concerns expressed into account, explain in writing the reasons for not doing so; (k) resolution plans referred to in Article 12 are complied with unless, taking into account the circumstances of the case, deviation from those plans is necessary in order to better achieve the resolution objectives; (l) transparency is ensured towards the relevant authorities wherever possible, and in any case where a proposed decision or action is likely to have implications on the financial stability or fiscal resources of any relevant Member State; (m) they coordinate and cooperate as closely as possible, also with the goal to lower the overall cost of resolution; and (n) the following are kept to a minimum, to the extent possible: negative economic and social effects, including negative impacts on financial stability, of any decision on all the Member States where the CCP provides services and where its clearing members, and to the extent the information is available, their clients and indirect clients, including where those clients or indirect clients are designated by Member States as O-SIIs, and any linked FMIs, including interoperable CCPs, are established. Article 8 Information exchange 1. Resolution authorities, competent authorities and ESMA shall, on their own initiative or on request, provide each other in a timely manner with all the information relevant for the exercise of their tasks under this Regulation. 2. By way of derogation from paragraph 1, the resolution authorities shall only divulge confidential information provided by a third-country authority where that authority has given its prior written consent. 3. Resolution authorities shall provide the competent ministry with all information relating to decisions or measures that require notification, consultation or consent of that ministry. TITLE III PREPARATION CHAPTER I Recovery and resolution planning Section 1 Recovery planning Article 9 Recovery plans 1. CCPs shall draw up and maintain a recovery plan providing for measures to be taken in the case of both default and non-default events and combinations of both, in order to restore their financial soundness, without any extraordinary public financial support, and allow them to continue to provide critical functions following a significant deterioration of their financial situation or a risk of breaching their capital and prudential requirements under Regulation (EU) No 648/2012. 2. The measures included in the recovery plan shall: (a) comprehensively and effectively address all the risks identified in the different scenarios, including possible uncovered liquidity shortfalls; (b) in the case of losses due to a default event, ensure the re-establishment of a matched book and the full allocation of uncovered losses to clearing members, and to their clients if those clients are direct creditors of the CCP, and to shareholders, taking into account the interests of all stakeholders; (c) include loss-absorbing arrangements that are adequate to cover the losses that might arise from all types of non-default events; and (d) enable the replenishment of the CCP\u2019s financial resources, including its own funds, to a level sufficient in order for the CCP to meet its obligations under Regulation (EU) No 648/2012 and to support the continued and timely operation of the critical functions of the CCP. 3. The recovery plan shall include a framework of indicators based on the risk profile of the CCP, that identify the circumstances under which measures in the recovery plan are to be taken. The indicators may be of either a qualitative or a quantitative nature relating to the financial soundness and operational viability of the CCP and should enable recovery measures to be taken early enough to provide sufficient time for the plan to be implemented. 4. CCPs shall put in place appropriate arrangements for the regular monitoring of the indicators referred to in paragraph 3. CCPs shall report to their competent authorities on the outcome of that monitoring. Competent authorities shall transmit information to the supervisory college, where they deem such information significant. 5. ESMA shall, in cooperation with the ESRB, by 12 February 2022, issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 to specify the minimum list of qualitative and quantitative indicators referred to in paragraph 3 of this Article. 6. CCPs shall include provisions in their operating rules, outlining the procedures to be followed by them where, in order to achieve the goals of the recovery process, they propose to: (a) take measures provided for in their recovery plan despite the fact that the relevant indicators have not been met; or (b) refrain from taking measures provided for in their recovery plan despite the fact that the relevant indicators have been met. Any decision taken pursuant to this paragraph and its justification shall be notified to the competent authority without delay. 7. Where a CCP intends to activate its recovery plan, it shall notify the competent authority of the nature and magnitude of the problems it has identified, setting out all relevant circumstances and indicating the recovery measures or other measures it intends to take to address the situation as well as the envisaged time-frame to restore its financial soundness by use of those measures. Where the competent authority considers that a recovery measure that the CCP intends to take may cause significant adverse effects to the financial system or is unlikely to be effective, it may require the CCP to refrain from taking that measure. Following the notification received under the second subparagraph of paragraph 6 of this Article, the competent authority shall immediately assess whether the circumstances require the use of early intervention powers in accordance with Article 18. 8. The competent authority shall promptly inform the resolution authority and the supervisory college, and the resolution authority shall promptly inform the resolution college, of any notification received in accordance with the second subparagraph of paragraph 6 and with the first subparagraph of paragraph 7, and of any subsequent instruction by the competent authority in accordance with the second subparagraph of paragraph 7. Where the competent authority is informed in accordance with the first subparagraph of paragraph 7 of this Article, it shall restrict or prohibit any remuneration of equity and instruments treated as equity, including dividend payments and buybacks by the CCP, to the fullest extent possible without triggering an event of default, and it may restrict or prohibit any payments of variable remuneration as defined by the CCP\u2019s remuneration policy pursuant to Article 26(5) of Regulation (EU) No 648/2012, discretionary pension benefits or severance packages to senior management as defined in point 29 of Article 2 of Regulation (EU) No 648/2012. 9. CCPs shall, at least annually and in any case after any change to their legal or organisational structure or business or financial situation which could have a material effect on those plans or otherwise necessitate a change to the plans, review, test and, where necessary, update their recovery plans. Competent authorities may require CCPs to update their recovery plans more frequently. 10. Recovery plans shall be drawn up in accordance with Section A of the Annex and take into account all relevant interdependencies within the group to which the CCP belongs. Competent authorities may require CCPs to include additional information in their recovery plans. Where relevant, the competent authority of the CCP shall consult the competent authority of the CCP\u2019s parent undertaking. 11. Recovery plans shall: (a) not assume any access to or receipt of extraordinary public financial support, central bank emergency liquidity assistance or central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms; (b) consider the interests of all stakeholders that are likely to be affected by the plan, including clearing members and, to the extent that the information is available, their direct and indirect clients; and (c) ensure that clearing members do not have unlimited exposures toward the CCP and stakeholders\u2019 potential losses and liquidity shortfalls are transparent, measurable, manageable and controllable. 12. ESMA shall, in cooperation with the ESRB, by 12 February 2022 issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 further specifying the range of scenarios to be considered for the purposes of paragraph 1 of this Article. In issuing such guidelines, ESMA shall take into account, where appropriate, supervisory stress testing exercises. 13. Where the CCP is part of a group and contractual parental or group support agreements form part of the recovery plan, the recovery plan shall contemplate scenarios in which those agreements cannot be honoured. 14. Following a default or a non-default event, a CCP shall use an additional amount of its pre-funded dedicated own resources, prior to the use of the arrangements and measures referred to in point 15 of Section A of the Annex to this Regulation. That amount shall not be lower than 10 % nor higher than 25 % of the risk-based capital requirements calculated in accordance with Article 16(2) of Regulation (EU) No 648/2012. To comply with that requirement, the CCP may use the amount of capital it holds, in addition to its minimum capital requirements, to comply with the notification threshold referred to in the delegated act adopted on the basis of Article 16(3) of Regulation (EU) No 648/2012. 15. ESMA shall, in close cooperation with EBA and after consulting the ESCB, develop draft regulatory technical standards specifying the methodology for calculation and maintenance of the additional amount of pre-funded dedicated own resources to be used in accordance with paragraph 14. When developing those technical standards, ESMA shall take into account all of the following: (a) the structure and the internal organisation of CCPs and the nature, scope and complexity of their activities; (b) the structure of incentives of the shareholders, management and clearing members of CCPs and of the clients of clearing members; (c) the appropriateness for CCPs, depending on the currencies in which the financial instruments they clear are denominated, the currencies accepted as collateral and the risk stemming from their activities, in particular where they do not clear OTC derivatives as defined in point (7) of Article 2 of Regulation (EU) No 648/2012, to invest that additional amount of dedicated own resources in assets other than those referred to in Article 47(1) of that Regulation; and (d) the rules applying to and the practices of third-country CCPs, as well as the international developments concerning the recovery and resolution of CCPs, in order to preserve the competitiveness of internationally active Union CCPs, and the competitiveness of Union CCPs compared to third-country CCPs providing clearing services in the Union. Where ESMA concludes, on the basis of the criteria referred to in point (c) of the first subparagraph, that it is appropriate for certain CCPs to invest that additional amount of pre-funded dedicated own resources in assets other than those referred to in Article 47(1) of Regulation (EU) No 648/2012, it shall also specify: (a) the procedure through which, in the event that those resources are not immediately available, CCPs may resort to recovery measures that require the financial contribution of non-defaulting clearing members; (b) the procedure that CCPs shall follow to subsequently reimburse the non-defaulting clearing members referred to in point (a) up to the amount to be used in accordance with paragraph 14 of this Article. ESMA shall submit the draft regulatory technical standards referred to in the first subparagraph to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 16. The CCP shall develop adequate mechanisms to involve linked FMIs and stakeholders which would bear losses, incur costs or contribute to cover liquidity shortfalls in the event that the recovery plan was implemented in the process of drawing-up of that plan. 17. The board of the CCP shall assess, taking into account the advice of the risk committee in accordance with Article 28(3) of Regulation (EU) No 648/2012, and approve the recovery plan before submitting it to the competent authority. 18. Where the board of the CCP has decided not to follow the advice of the risk committee, it shall promptly inform the competent authority in accordance with Article 28(5) of Regulation (EU) No 648/2012 and explain its decision in detail to the competent authority. 19. Recovery plans shall be integrated in the corporate governance and the overall risk management framework of the CCP. 20. The measures set out in the recovery plans that create financial or contractual obligations on clearing members and, where relevant, clients and indirect clients, linked FMIs or trading venues shall form part of the operating rules of CCPs. 21. CCPs shall ensure that the measures set out in the recovery plans are enforceable at all times in all jurisdictions where the clearing members, linked FMIs or trading venues are located. 22. The obligation of CCPs to include in their recovery plans the right to make a recovery cash call and, if applicable, to reduce the value of any gains payable by the CCPs to non-defaulting clearing members shall not be applicable to the entities referred to in Articles 1(4) and 1(5) of Regulation (EU) No 648/2012. 23. Clearing members shall communicate to their clients in a clear and transparent manner if and in what way measures in the CCP\u2019s recovery plan may affect them. Article 10 Assessment of recovery plans 1. CCPs shall submit their recovery plans to the competent authority. 2. The competent authority shall transmit each plan to the supervisory college and to the resolution authority without undue delay. The competent authority shall review the recovery plan and assess the extent to which it satisfies the requirements set out in Article 9 within six months of the submission of the plan and in coordination with the supervisory college in accordance with the procedure in Article 11. 3. When assessing the recovery plan, the competent authority and the supervisory college shall take into consideration the following factors: (a) the CCP\u2019s capital structure, its default waterfall, the level of complexity of the organisational structure, the substitutability of its activities and the risk profile of the CCP, including in terms of financial, operational and cyber risks; (b) the overall impact that the implementation of the recovery plan would have on: (i) clearing members, and to the extent the information is available, their clients and indirect clients, including where they have been designated as O-SIIs; (ii) any linked FMIs; (iii) financial markets, including trading venues, served by the CCP; and (iv) the financial system of any Member State and the Union as a whole; (c) whether the recovery tools and their sequence specified by the recovery plan create appropriate incentives for the CCP\u2019s owners, clearing members, and where possible their clients, as relevant, to control the amount of risk that they bring to or incur in the system, monitor the CCP\u2019s risk-taking and risk management activities and contribute to the CCP\u2019s default management process. 4. When assessing the recovery plan, the competent authority shall take parental support agreements into consideration as valid parts of the recovery plan only where those agreements are contractually binding. 5. The resolution authority shall examine the recovery plan in order to identify any measures which may adversely impact the resolvability of the CCP. Where any such measures are identified, the resolution authority shall bring them to the attention of the competent authority and make recommendations to the competent authority on ways to address the adverse impact of those measures on the resolvability of the CCP, within two months of the transmission of each recovery plan by the competent authority. 6. Where the competent authority decides not to act on the recommendations of the resolution authority pursuant to paragraph 5, it shall fully justify that decision to the resolution authority. 7. Where the competent authority agrees with the recommendations of the resolution authority, or considers in coordination with the supervisory college in accordance with Article 11 that there are material deficiencies in the recovery plan or material impediments to its implementation, it shall notify the CCP and shall give it the opportunity to submit its views. 8. The competent authority, taking into account the CCP\u2019s views, may require the CCP to submit, within two months, extendable by one month with the competent authority\u2019s approval, a revised plan demonstrating how those deficiencies or impediments are addressed. The revised plan shall be assessed in accordance with paragraphs 2 to 7. 9. Where the competent authority, after consulting the resolution authority and in coordination with the supervisory college in accordance with the procedure set out in Article 11, considers that the deficiencies and impediments have not been adequately addressed by the revised plan, or where the CCP has not submitted a revised plan, it shall require the CCP to make specific changes to the plan within a reasonable period, as defined by the competent authority. 10. Where it is not possible to adequately remedy the deficiencies or impediments through specific changes to the plan, the competent authority, after consulting the resolution authority and in coordination with the supervisory college in accordance with the procedure set out in Article 11, shall require the CCP to identify within a reasonable timeframe any changes to be made to its business in order to address the deficiencies in or impediments to the implementation of the recovery plan. Where the CCP fails to identify such changes within the timeframe set by the competent authority, or where the competent authority, after consulting the resolution authority and in coordination with the supervisory college in accordance with the procedures set out in Article 11, considers that the actions proposed would not adequately address the deficiencies or impediments to the implementation of the recovery plan, the competent authority shall require the CCP to take within a reasonable period, as defined by the competent authority, specified actions with regard to one or more of the following objectives, taking into account the seriousness of the deficiencies and impediments and the effect of the measures on the CCP\u2019s business and ability to remain in compliance with Regulation (EU) No 648/2012: (a) to reduce the risk profile of the CCP; (b) to enhance the CCP\u2019s ability to be recapitalised in a timely manner to meet its capital and prudential requirements; (c) to review the CCP\u2019s strategy and structure; (d) to make changes to the default waterfall, recovery measures and other loss allocation arrangements so as to improve resolvability and the resilience of critical functions; (e) to make changes to the governance structure of the CCP. 11. The request referred to in the second subparagraph of paragraph 10 shall be reasoned and notified in writing to the CCP. 12. ESMA, in cooperation with the ESCB and the ESRB, shall develop draft regulatory technical standards further specifying the factors referred to in points (a), (b) and (c) of paragraph 3. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 11 Coordination procedure for recovery plans 1. The supervisory college shall examine the recovery plan and, where any member of the college considers that there are material deficiencies in the recovery plan or any material impediment to its implementation, that member shall make recommendations to the competent authority of the CCP with regard to those matters within two months of the transmission of the recovery plan by the competent authority. 2. The supervisory college shall reach a joint decision on all of the following issues: (a) the review and assessment of the recovery plan; (b) the application of the measures referred to in Article 10(7), (8), (9) and (10). 3. The supervisory college shall reach a joint decision on the issues referred to in paragraph 2 within four months of the date of the transmission of the recovery plan by the competent authority. ESMA may, at the request of a competent authority within the supervisory college, assist the supervisory college in reaching a joint decision in accordance with point (c) of Article 31(2) of Regulation (EU) No 1095/2010. 4. Where, after four months from the date of transmission of the recovery plan, the college has failed to reach a joint decision on the issues referred to in paragraph 2, the competent authority of the CCP shall make its own decision. The competent authority of the CCP shall make the decision referred to in the first subparagraph taking into account the views of the other college members expressed during the four-month period. The competent authority of the CCP shall notify in writing that decision to the CCP and to the other members of the college. 5. Where, by the end of that four-month period, a joint decision has not been reached and a simple majority of the voting members disagree with the competent authority\u2019s proposal for a joint decision on a matter in relation to the assessment of recovery plans or implementation of the measures pursuant to points (a), (b) and (d) of Article 10(10) of this Regulation, any of the voting members concerned, based on that majority, may refer that matter to ESMA in accordance with Article 19 of Regulation (EU) No 1095/2010. The competent authority of the CCP shall await the decision taken by ESMA in accordance with Article 19(3) of Regulation (EU) No 1095/2010 and decide in accordance with the decision of ESMA. 6. The four-month period shall be deemed to be the conciliation phase within the meaning of Regulation (EU) No 1095/2010. ESMA shall take its decision within one month of the referral of the matter to it. The matter shall not be referred to ESMA after the end of the four-month period or after a joint decision has been reached. In the absence of an ESMA decision within one month, the decision of the competent authority of the CCP shall apply. Section 2 Resolution planning Article 12 Resolution plans 1. The resolution authority of the CCP shall, after consultation with the competent authority and in coordination with the resolution college, in accordance with the procedure set out in Article 14, draw up a resolution plan for the CCP. 2. The resolution plan shall provide for the resolution actions that the resolution authority may take where the CCP meets the conditions for resolution referred to in Article 22. 3. The resolution plan shall take into consideration at least the following: (a) the CCP\u2019s failure, including in situations of broader financial instability or system wide events, due to one of the following or their combination: (i) default events, and (ii) non-default events; (b) the impact that the implementation of the resolution plan would have on: (i) the clearing members, and to the extent the information is available, their clients and indirect clients, including where they have been designated as O-SIIs and those likely to be subject to recovery measures or resolution actions in accordance with Directive 2014/59/EU; (ii) any linked FMIs; (iii) financial markets, including trading venues, served by the CCP; and (iv) the financial system in any Member State or the Union as a whole, and, to the extent possible, in third countries where it provides services; (c) the manner and the circumstances under which a CCP may apply for the use of central bank facilities provided under standard collateralisation, tenor and interest rate terms and the identification of the assets that would be expected to qualify as collateral. 4. The resolution plan shall not assume any of the following: (a) extraordinary public financial support; (b) central bank emergency liquidity assistance; (c) central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. 5. The resolution plan shall make prudent assumptions regarding the financial resources available as resolution tools that may be required to achieve the resolution objectives and the resources that are expected to be available in accordance with the CCP\u2019s rules and arrangements at the time of entering into resolution. Those prudent assumptions shall take into account the relevant findings of latest stress tests carried out in accordance with Article 32(2) of Regulation (EU) No 1095/2010, specified in point (b) of Article 24a(7) of Regulation (EU) No 648/2012, as well as scenarios of extreme market conditions beyond those in the CCP\u2019s recovery plan. 6. The resolution authority of a CCP shall, after consultation with the competent authority and in coordination with the resolution college in accordance with the procedure in Article 14, review resolution plans and where appropriate update them, at least annually and in any case after changes to the legal or organisational structure of the CCP, its business or financial situation or any other change that materially affects the effectiveness of the plan. The CCP and the competent authority shall promptly inform the resolution authority of any such change. 7. The resolution plan shall specify the circumstances and different scenarios for applying the resolution tools and exercising the resolution powers. It shall clearly distinguish, in particular through different scenarios, between failure caused by default events, non-default events, and a combination of both, as well as between different types of non-default events. The resolution plan shall include the following, quantified whenever appropriate and possible: (a) a summary of the key elements of the plan, distinguishing between default events, non-default events and a combination of the two; (b) a summary of the material changes to the CCP that have occurred since the resolution plan was last updated; (c) a description of how the CCP\u2019s critical functions could be legally and economically separated, to the extent necessary, from its other functions so as to ensure the continuity of its critical functions in the resolution of the CCP; (d) an estimation of the timeframe for implementing each material aspect of the plan, including for replenishing the CCP\u2019s financial resources; (e) a detailed description of the assessment of resolvability carried out in accordance with Article 15; (f) a description of any measures required pursuant to Article 16 to address or remove impediments to resolvability identified as a result of the assessment carried out in accordance with Article 15; (g) a description of the processes for determining the value and marketability of the critical functions and assets of the CCP; (h) a detailed description of the arrangements for ensuring that the information required pursuant to Article 13 is up to date and available to the resolution authorities at all times; (i) an explanation as to how resolution actions could be financed without the assumption of the elements referred to in paragraph 4; (j) a detailed description of the different resolution strategies that could be applied according to the different possible scenarios and their related timeframes; (k) a description of critical interdependencies between the CCP and other market participants and between the CCP and critical service providers, interoperability arrangements and links with other FMIs, as well as ways to address all of those interdependencies; (l) a description of critical intra-group interdependencies as well as ways to address them; (m) a description of the different options to ensure: (i) access to payments and clearing services and other infrastructures; (ii) timely settlement of obligations due to clearing members and, where applicable, their clients and any linked FMIs; (iii) access of clearing members, and, where applicable, their clients on a transparent and non-discriminatory basis to securities or cash accounts provided by the CCP and securities or cash collateral posted to and held by the CCP that is owed to such participants; (iv) continuity in the operations of links between the CCP and other FMIs and between the CCP and trading venues; (v) preservation of the portability of the positions and related assets of direct and indirect clients; and (vi) preservation of the licenses, authorisations, recognitions and legal designations of a CCP where necessary for the continued performance of the CCP\u2019s critical functions including its recognition for the purposes of the application of the relevant settlement finality rules and the participation in or links with other FMIs or with trading venues; (n) a description of how the resolution authority will obtain the necessary information to perform the valuation referred to in Article 24; (o) an analysis of the impact of the plan on the employees of the CCP, including an assessment of any associated costs, and a description of envisaged procedures to consult with staff during the resolution process, taking into account any national rules and systems for dialogue with social partners; (p) a plan for communicating with the media and the public so as to be as transparent as possible; (q) a description of essential operations and systems for maintaining the continuous functioning of the CCP\u2019s operational processes; (r) a description of the arrangements for notifying the resolution college in accordance with Article 72(1); (s) a description of the measures to facilitate the portability of positions and related assets of the clearing members and clients of the defaulting CCP from the defaulting CCP to another CCP or a bridge CCP while not affecting the contractual relationships between the clearing members and their clients. 8. The information referred to in point (a) of paragraph 7 shall be disclosed to the CCP concerned. The CCP may express its opinion in writing on the resolution plan to the resolution authority. That opinion shall be included in the plan. 9. ESMA, after consulting the ESRB and taking into account the relevant provisions of the delegated acts adopted on the basis of Article 10(9) of Directive 2014/59/EU and respecting the principle of proportionality shall develop draft regulatory technical standards further specifying the contents of the resolution plan in accordance with paragraph 7 of this Article. When developing the draft regulatory technical standards, ESMA shall enable sufficient flexibility for resolution authorities to take into consideration the specificities of their national legal framework in the area of insolvency law, as well as the nature and complexity of the clearing business performed by the CCPs. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 13 CCPs\u2019 duty to cooperate and provide information 1. CCPs shall cooperate as necessary in the drawing up of resolution plans and provide their resolution authority, either directly or through their competent authority, with all the information necessary to draw up and implement those plans, including the information and analysis specified in Section B of the Annex. Competent authorities shall provide resolution authorities with any information referred to in the first subparagraph which is already available to them. 2. Resolution authorities may require CCPs to provide them with detailed records of the contracts referred to in Article 29 of Regulation (EU) No 648/2012 to which they are a party. Resolution authorities may specify a time limit to provide those records and may specify different time limits for different types of contracts. 3. A CCP shall exchange information in a timely manner with its competent authorities in order to facilitate the assessment of the risk profiles of the CCP and the interconnectedness with other FMIs, other financial institutions and with the financial system in general as referred to in Articles 9 and 10. Competent authorities shall transmit information to the supervisory college, where they deem such information significant. Article 14 Coordination procedure for resolution plans 1. The resolution authority shall transmit to the resolution college a draft resolution plan, the information provided in accordance with Article 13 and any additional information relevant to the resolution college. 2. The resolution college shall reach a joint decision regarding the resolution plan and any changes thereto within a four-month period from the date of the transmission of that plan by the resolution authority referred to in paragraph 1. The resolution authority shall ensure that ESMA is provided with all the information that is relevant to its role in accordance with this Article. 3. The resolution authority may, in accordance with Article 4(4), decide to involve third-country authorities when drawing up and reviewing the resolution plan, provided that they meet the confidentiality requirements laid down in Article 73 and are from jurisdictions in which any of the following entities are established: (a) the CCP\u2019s parent undertaking, where applicable; (b) the clearing members of the CCP where their contribution to the default fund of the CCP is, on an aggregate basis over a one-year period, higher than those of the third Member State with the largest contributions as referred to in point (c) of Article 18(2) of Regulation (EU) No 648/2012; (c) the CCP\u2019s subsidiaries, where applicable; (d) other providers of critical services to the CCP; (e) interoperable CCPs. 4. ESMA may, at the request of a resolution authority, assist the resolution college in reaching a joint decision in accordance with point (c) of Article 31(2) of Regulation (EU) No 1095/2010. 5. Where, after four months from the date of transmission of the resolution plan, the resolution college has failed to reach a joint decision, the resolution authority shall make its own decision on the resolution plan. The resolution authority shall make its decision taking into account the views of the other resolution college members expressed during the four-month period. The resolution authority shall notify in writing the decision to the CCP and to the other members of the resolution college. 6. Where, by the end of the four-month period referred to in paragraph 5 of this Article, a joint decision has not been reached and a simple majority of the voting members disagree with the resolution authority\u2019s proposal for a joint decision on a matter in relation to the resolution plan, any of the voting members concerned, based on that majority, may refer that matter to ESMA in accordance with Article 19 of Regulation (EU) No 1095/2010. The resolution authority of the CCP shall await the decision taken by ESMA in accordance with Article 19(3) of Regulation (EU) No 1095/2010 and decide in accordance with the decision of ESMA. The four-month period shall be deemed to be the conciliation phase within the meaning of Regulation (EU) No 1095/2010. ESMA shall take its decision within one month of the referral of the matter to it. The matter shall not be referred to ESMA after the end of the four-month period or after a joint decision has been reached. In the absence of an ESMA decision within one month, the decision of the resolution authority shall apply. 7. Where a joint decision is taken pursuant to paragraph 1 and any resolution authority or competent ministry considers under paragraph 6 that the subject matter of the disagreement impinges on the fiscal responsibilities of its Member State, the resolution authority of the CCP shall initiate a reassessment of the resolution plan. CHAPTER II Resolvability Article 15 Assessment of resolvability 1. The resolution authority, in coordination with the resolution college in accordance with the procedure set out in Article 17, and after consultation with the competent authority, shall assess the extent to which a CCP is resolvable without assuming any of the following: (a) extraordinary public financial support; (b) central bank emergency liquidity assistance; (c) central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. 2. A CCP shall be deemed resolvable where the resolution authority considers it feasible and credible to either liquidate it under normal insolvency proceedings or to resolve it applying the resolution tools and exercising the resolution powers while ensuring the continuity of the CCP\u2019s critical functions and avoiding any use of extraordinary public financial support and, to the maximum extent possible, any significant adverse effect on the financial system and the potential for undue disadvantage to affected stakeholders. The adverse effects referred to in the first subparagraph shall include broader financial instability or system wide events in any Member State. The resolution authority shall notify ESMA in a timely manner where it considers that a CCP is not resolvable. 3. Upon request by the resolution authority, a CCP shall demonstrate that: (a) there are no impediments to the reduction of the value of instruments of ownership following the exercise of resolution powers, regardless of whether outstanding contractual arrangements or other measures in the CCP\u2019s recovery plan have been fully exhausted; and (b) the contracts of the CCP with clearing members or third parties do not enable those clearing members or third parties to successfully challenge the exercise of resolution powers by a resolution authority or otherwise avoid being subject to those powers. 4. For the purposes of the assessment of resolvability referred to in paragraph 1, the resolution authority shall, as relevant, examine the matters specified in Section C of the Annex. 5. By 12 August 2022, ESMA, in close cooperation with the ESRB, shall issue guidelines to promote the convergence of resolution practices regarding the application of Section C of the Annex to this Regulation in accordance with Article 16 of Regulation (EU) No 1095/2010. 6. The resolution authority in coordination with the resolution college shall make the resolvability assessment at the same time as drawing up and updating the resolution plan in accordance with Article 12. Article 16 Addressing or removing impediments to resolvability 1. Where, following the assessment in Article 15, the resolution authority, in coordination with the resolution college in accordance with the procedure set out in Article 17, concludes that there are material impediments to the resolvability of a CCP, the resolution authority, in cooperation with the competent authority, shall prepare and submit a report to the CCP and to the resolution college. The report referred to in the first subparagraph shall analyse the material impediments to the effective application of the resolution tools and the exercise of the resolution powers in relation to the CCP, consider their impact on the business model of the CCP and recommend targeted measures to remove those impediments. 2. The requirement laid down in Article 14 for resolution colleges to reach a joint decision on resolution plans shall be suspended following the submission of the report referred to in paragraph 1 of this Article until the measures to remove the material impediments to resolvability have been accepted by the resolution authority pursuant to paragraph 3 of this Article or alternative measures have been decided pursuant to paragraph 4 of this Article. 3. Within four months of the date of receipt of the report submitted in accordance with paragraph 1 of this Article, the CCP shall propose to the resolution authority possible measures to address or remove the material impediments identified in the report. The resolution authority shall communicate to the resolution college any measure proposed by the CCP. The resolution authority and resolution college shall assess, in accordance with point (b) of Article 17(1), whether those measures effectively address or remove those impediments. 4. Where the resolution authority in coordination with the resolution college in accordance with the procedure set out in Article 17 concludes that the measures proposed by a CCP in accordance with paragraph 3 of this Article would not effectively reduce or remove the impediments identified in the report, the resolution authority shall identify alternative measures which it shall communicate to the resolution college for joint decision in accordance with point (c) of Article 17(1). The alternative measures referred to in the first subparagraph shall take into account the following: (a) the threat to financial stability of those material impediments to the resolvability of a CCP; (b) the likely effect of the alternative measures on: (i) the CCP, including its business model and operational efficiency; (ii) its clearing members, and to the extent the information is available, their clients and indirect clients, including where they have been designated as O-SIIs; (iii) any linked FMIs; (iv) financial markets, including trading venues, served by the CCP; (v) the financial system in any Member State or the Union as a whole; and (vi) the internal market; and (c) the effects on the provision of integrated clearing services for different products and portfolio margining across asset classes. For the purposes of points (a) and (b) of the second subparagraph, the resolution authority shall consult the competent authority and the resolution college and, where appropriate, relevant designated national macroprudential authorities. 5. The resolution authority shall notify the CCP in writing, either directly or indirectly through the competent authority, of the alternative measures to take in order to achieve the objective of removing impediments to resolvability. The resolution authority shall justify why the measures proposed by the CCP would not be able to remove the material impediments to resolvability and how the alternative measures would be effective in doing so. 6. The CCP shall propose within one month a plan to comply with the alternative measures, with a reasonable timeframe for the implementation of the plan. If deemed necessary by the resolution authority, the resolution authority may shorten or extend the proposed timeframe. 7. For the purposes of paragraph 4, the resolution authority may, after consulting the competent authority and while allowing for a reasonable timeframe for implementation: (a) require the CCP to revise or draw up service agreements, whether intra-group or with third parties, to cover the provision of critical functions; (b) require the CCP to limit its maximum individual and aggregate uncovered exposures; (c) require the CCP to make changes to how it collects and holds margins pursuant to Article 41 of Regulation (EU) No 648/2012; (d) require the CCP to make changes to the composition and number of its default funds referred to in Article 42 of Regulation (EU) No 648/2012; (e) impose on the CCP specific or regular additional information requirements; (f) require the CCP to divest specific assets; (g) require the CCP to limit or cease specific existing or proposed activities; (h) require the CCP to make changes to its recovery plan, operating rules and other contractual arrangements; (i) restrict or prevent the development of new or existing business lines or provision of new or existing services; (j) require changes to legal or operational structures of the CCP or any group entity directly or indirectly under its control to ensure that critical functions may be legally and operationally separated from other functions through the application of resolutions tools; (k) require the CCP to operationally and financially segregate its different clearing services so as to isolate some specific asset classes from other asset classes and where deemed appropriate, to restrict netting sets covering different asset classes; (l) require the CCP to set up a parent undertaking in the Union; (m) require the CCP to issue liabilities that can be written down and converted or to set aside other financial resources to increase the capacity for loss absorption, recapitalisation and the replenishment of pre-funded resources; (n) require the CCP to take other steps to enable capital, other liabilities and contracts to be able to absorb losses, to recapitalise the CCP or to replenish pre-funded resources. Actions considered may include in particular attempting to renegotiate any liability the CCP has issued or to revise contractual terms, with a view to ensuring that any decision of the resolution authority to write down, convert or restructure that liability, instrument or contract would be effected under the law of the jurisdiction governing that liability or instrument; (o) where the CCP is a subsidiary, coordinate with relevant authorities with a view to requiring the parent undertaking to set up a separate holding company to control the CCP, where that measure is necessary in order to facilitate the resolution of the CCP and to avoid the adverse effects that the application of the resolution tools and the exercise of the resolution powers could have on other entities of the group; (p) restrict or prohibit interoperability links of the CCP where such a restriction or prohibition is necessary in order to avoid adverse effects on the achievement of resolution objectives. Article 17 Coordination procedure to address or remove impediments to resolvability 1. The resolution college shall reach a joint decision regarding: (a) the identification of the material impediments to resolvability pursuant to Article 15(1); (b) the assessment of the measures proposed by the CCP pursuant to Article 16(3), as necessary; (c) the alternative measures required pursuant to Article 16(4). 2. The joint decision on the identification of material impediments to resolvability referred to in point (a) of paragraph 1 of this Article shall be adopted within four months of the submission of the report referred to in Article 16(1) to the resolution college. 3. The joint decision referred to in point (b) of paragraph 1 of this Article shall be adopted within four months of submission of the CCP\u2019s proposed measures to remove impediments to resolvability as referred to in Article 16(3). 4. The joint decision referred to in point (c) of paragraph 1 of this Article shall be adopted within four months of the communication of the alternative measures to the resolution college as referred to in Article 16(4). 5. The joint decisions referred to in paragraph 1 shall be reasoned and notified in writing by the resolution authority to the CCP and, where the resolution authority deems it relevant, its parent undertaking. 6. ESMA may, at the request of the resolution authority of the CCP, assist the resolution college in reaching a joint decision in accordance with point (c) of Article 31(2) of Regulation (EU) No 1095/2010. 7. Where, after four months from the date of transmission of the report provided for in Article 16(1), the resolution college has failed to adopt a joint decision, the resolution authority shall take its own decision on the appropriate measures to be taken in accordance with Article 16(5). The resolution authority shall take its decision having taken into account the views of the other resolution college members expressed during the four-month period. The resolution authority shall notify the decision to the CCP, to its parent undertaking where relevant, and to the other members of the resolution college in writing. 8. Where, by the end of the four-month period referred to in paragraph 7 of this Article, a joint decision has not been reached and a simple majority of the voting members disagree with the resolution authority\u2019s proposal for a joint decision on a matter referred to in point (j), (l) or (o) of Article 16(7) of this Regulation, any of the voting members concerned, based on that majority, may refer that matter to ESMA in accordance with Article 19 of Regulation (EU) No 1095/2010. The resolution authority of the CCP shall await the decision taken by ESMA in accordance with Article 19(3) of Regulation (EU) No 1095/2010 and decide in accordance with the decision of ESMA. The four-month period shall be deemed to be the conciliation phase within the meaning of Regulation (EU) No 1095/2010. ESMA shall take its decision within one month of the referral of the matter to it. The matter shall not be referred to ESMA after the end of the four-month period or after a joint decision has been reached. In the absence of an ESMA decision within one month, the decision of the resolution authority shall apply. TITLE IV EARLY INTERVENTION Article 18 Early intervention measures 1. Where a CCP infringes, or is likely to infringe in the near future, the capital and prudential requirements of Regulation (EU) No 648/2012, or poses a risk to financial stability in the Union or in one or more of its Member States, or where the competent authority has determined that there are other indications of an emerging crisis situation that could affect the operations of the CCP, in particular, its ability to provide clearing services, the competent authority may: (a) require the CCP to update the recovery plan in accordance with Article 9(6) of this Regulation, where the circumstances that required early intervention are different from the assumptions set out in the initial recovery plan; (b) require the CCP to implement one or more of the arrangements or measures set out in the recovery plan within a specific timeframe. Where the plan is updated pursuant to point (a), those arrangements or measures shall include any updated arrangements or measures; (c) require the CCP to identify the causes of the infringement or likely infringement as mentioned in paragraph 1 and draw up an action programme, including suitable measures and timeframes; (d) require the CCP to convene a meeting of its shareholders or, if the CCP fails to comply with that requirement, convene the meeting itself. In both cases the competent authority shall set the agenda, including the decisions to be considered for adoption by the shareholders; (e) require one or more members of the board or senior management to be removed or replaced where any of those persons is found unfit to perform their duties pursuant to Article 27 of Regulation (EU) No 648/2012; (f) require changes to the business strategy of the CCP; (g) require changes to the legal or operational structures of the CCP; (h) provide the resolution authority with all the information necessary to update the CCP\u2019s resolution plan in order to prepare for the possible resolution of the CCP and the valuation of its assets and liabilities in accordance with Article 24 of this Regulation, including any information acquired through on-site inspections; (i) require, where necessary and in accordance with paragraph 4, the implementation of the CCP\u2019s recovery measures; (j) require the CCP to abstain from the implementation of certain recovery measures where the competent authority has determined that the implementation of those measures may have an adverse effect on financial stability in the Union or in one or more of its Member States; (k) require the CCP to replenish its financial resources in a timely manner in order to comply or maintain compliance with its capital and prudential requirements; (l) require the CCP to instruct clearing members to invite their clients to participate directly in auctions organised by the CCP when the nature of the auction justifies this exceptional participation. Clearing members shall inform their clients comprehensively about the auction following the instructions received from the CCP. In particular, the CCP shall specify the deadline after which it will not be possible to participate in the auction. Clients shall directly inform the CCP before this deadline of their willingness to participate in the auction. The CCP shall then facilitate the bidding process for those clients. A client shall only be authorised to participate in the auction if it is able to demonstrate to the CCP that it has set up the appropriate contractual relationship with a clearing member to execute and clear the transactions that may result from the auction; (m) restrict or prohibit any remuneration of equity and instruments treated as equity to the fullest extent possible without triggering an event of default, including dividend payments and buybacks by the CCP, and it may restrict, prohibit or freeze any payments of variable remuneration as defined by the CCP\u2019s remuneration policy pursuant to Article 26(5) of Regulation (EU) No 648/2012, discretionary pension benefits or severance packages to senior management as defined in point 29 of Article 2 of Regulation (EU) No 648/2012. 2. For each of the measures referred to in paragraph 1, the competent authority shall set an appropriate deadline and evaluate the effectiveness of those measures once they have been taken. 3. The competent authority shall only apply the measures in points (a) to (m) of paragraph 1 after taking account of the impact of those measures in other Member States where the CCP operates or provides services and after informing the relevant competent authorities, in particular where the CCP\u2019s operations are critical or important for local financial markets, including the places in which clearing members, linked trading venues and FMIs are established. 4. The competent authority shall apply the measure in point (i) of paragraph 1 only where that measure is in the public interest and is necessary to achieve any of the following objectives: (a) to maintain the financial stability in the Union or in one or more of its Member States; (b) to maintain the continuity of the critical functions of the CCP and access to critical functions on a transparent and non-discriminatory basis; (c) to maintain or restore the financial resilience of the CCP. The competent authority shall not apply the measure in point (i) of paragraph 1 in relation to measures involving the transfer of property, rights or liabilities of another CCP. 5. Where a CCP uses contributions to the default fund of the non-defaulting clearing members in accordance with Article 45(3) of Regulation (EU) No 648/2012, it shall inform the competent authority and the resolution authority without undue delay and explain whether that event reflects weaknesses or problems of that CCP. 6. Where the conditions referred to in paragraph 1 are met, the competent authority shall notify ESMA and the resolution authority and consult the supervisory college on the envisaged measures provided for in paragraph 1. Following those notifications and the consultation of the supervisory college, the competent authority shall decide whether to apply any of the measures provided for in paragraph 1. The competent authority shall notify the decision on the measures to be taken to the supervisory college, the resolution authority and ESMA. 7. The resolution authority, following the notification of the first subparagraph of paragraph 6 of this Article, may require the CCP to contact potential purchasers in order to prepare for its resolution, subject to the conditions laid down in Article 41 and the confidentiality provisions laid down in Article 73. 8. ESMA shall, by 12 February 2022, issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 to promote the consistent application of the triggers for the use of the measures referred to in paragraph 1 of this Article. Article 19 Removal of senior management and board 1. Where there is a significant deterioration in the financial situation of a CCP, or the CCP infringes its legal requirements, including its operating rules, and other measures taken in accordance with Article 18 are not sufficient to reverse that situation, competent authorities may require total or partial removal of the senior management or board of the CCP. Where the competent authority requires complete or partial removal of the senior management or board of the CCP, it shall notify ESMA, the resolution authority and the supervisory college. 2. The appointment of the new senior management or board shall be done in accordance with Article 27 of Regulation (EU) No 648/2012 and be subject to the approval or consent of the competent authority. Where the competent authority considers that replacement of the senior management or board as referred to in this Article is insufficient, it may appoint one or more temporary administrators to the CCP to replace or to temporarily work with the board and senior management of the CCP. Any temporary administrator shall have the qualifications, ability and knowledge required to carry out his or her functions and be free of any conflict of interests. Article 20 Provision of recompense to non-defaulting clearing members 1. Without prejudice to the responsibility of clearing members to take losses which go beyond the default waterfall, where a CCP in recovery caused by a non-default event has applied the arrangements and measures to reduce the value of any gains payable by the CCP to non-defaulting clearing members set out in its recovery plan, and as a result has not entered into resolution, the competent authority of the CCP may require the CCP to recompense the clearing members for their loss through cash payments or, where appropriate, may require the CCP to issue instruments recognising a claim on the future profits of the CCP. The possibility to provide recompense to non-defaulting clearing members shall not apply to their contractually committed losses in the default management or recovery phases. The cash payments or the value of instruments recognising a claim on future profits of the CCP issued to each affected non-defaulting clearing member shall be proportionate to its loss in excess of its contractual commitments. The instruments recognising a claim on future profits of the CCP shall entitle the possessor to receive payments from the CCP on an annual basis until the loss has been recouped, if possible in full, subject to an appropriate maximum number of years from the date of issuance. If the non-defaulting clearing members have passed on the excess losses to their clients, the non-defaulting clearing members shall be obliged to pass the payments received by the CCP on to their clients, to the extent that the losses being recompensed are related to client positions. An appropriate maximum share of the CCP\u2019s annual profits shall be used towards payments relating to those instruments. 2. ESMA shall develop draft regulatory technical standards to specify the order in which recompense must be paid, the appropriate maximum number of years and the appropriate maximum share of the CCP\u2019s annual profits referred to in the second subparagraph of paragraph 1. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. TITLE V RESOLUTION CHAPTER I Objectives, conditions and general principles Article 21 Resolution objectives 1. When applying the resolution tools and exercising the resolution powers, the resolution authority shall have regard to all the following resolution objectives, which are of equal significance and shall balance them as appropriate to the nature and circumstances of each case: (a) to ensure the continuity of the CCP\u2019s critical functions, in particular: (i) the timely settlement of the CCP\u2019s obligations to its clearing members and, where applicable, their clients; (ii) continuous access of clearing members and, where applicable, their clients to securities or cash accounts provided by the CCP and collateral in the form of financial assets held by the CCP; (b) to ensure the continuity of the links with other FMIs which, if disrupted, would have a material negative impact on financial stability in the Union or in one or more of its Member States as well as the timely completion of payment, clearing, settlement and record-keeping functions; (c) to avoid a significant adverse effect on the financial system in the Union or in one or more of its Member States, in particular by preventing or mitigating contagion of financial distress to the CCP\u2019s clearing members, their clients or to the wider financial system, including other FMIs, and by maintaining market discipline and public confidence; and (d) to protect public funds by minimising reliance on extraordinary public financial support and the potential risk of losses for taxpayers. 2. When pursuing the objectives set out in paragraph 1, the resolution authority shall seek to minimise the cost of resolution on all affected stakeholders and avoid destruction of the CCP\u2019s value, unless such destruction is necessary to achieve the resolution objectives. Article 22 Conditions for resolution 1. The resolution authority shall take a resolution action in relation to a CCP provided that all of the following conditions are met: (a) the CCP is failing or is likely to fail as determined by any of the following: (i) the competent authority, after consulting the resolution authority; (ii) the resolution authority after consulting the competent authority, where the resolution authority has the necessary tools for reaching that conclusion; (b) there is no reasonable prospect that any alternative private sector measures, including the CCP\u2019s recovery plan or other contractual arrangements, or supervisory action, including early intervention measures taken, would prevent the failure of the CCP within a reasonable timeframe, having regard to all relevant circumstances; (c) a resolution action is necessary in the public interest to achieve, while being proportionate to, one or more of the resolution objectives, and winding up the CCP under normal insolvency procedures would not meet those resolution objectives to the same extent. 2. For the purposes of point (a)(ii) of paragraph 1, the competent authority shall provide the resolution authority on its own initiative and without delay with any information that may give an indication that the CCP is failing or likely to fail. The competent authority shall also provide the resolution authority upon request with any other information needed in order to perform its assessment. 3. For the purposes of point (a) of paragraph 1, a CCP shall be deemed to be failing or likely to fail where one or more of the following circumstances apply: (a) the CCP infringes, or is likely to infringe, its authorisation requirements in a way that would justify the withdrawal of its authorisation pursuant to Article 20 of Regulation (EU) No 648/2012; (b) the CCP is unable, or is likely to be unable, to provide a critical function; (c) the CCP is unable, or is likely to be unable, to restore its viability through the implementation of its recovery measures; (d) the CCP is unable, or is likely to be unable, to pay its debts or other liabilities as they fall due; (e) the CCP requires extraordinary public financial support. 4. For the purposes of point (e) of paragraph 3, public financial support shall not be considered extraordinary public financial support where it meets all of the following conditions: (a) it takes the form of a State guarantee to back liquidity facilities provided by a central bank according to the central bank\u2019s conditions, or the form of a State guarantee of newly issued liabilities; (b) the State guarantees referred to in point (a) of this paragraph are required to remedy a serious disturbance in the economy of a Member State and preserve financial stability; and (c) the State guarantees referred to in point (a) of this paragraph are confined to solvent CCPs, conditional on final approval under the Union State aid framework, are of a precautionary and temporary nature, proportionate to remedy the consequences of the serious disturbance referred to in point (b) of this paragraph and are not used to offset losses that the CCP has incurred or is likely to incur in the future. 5. The resolution authority may also take a resolution action where it considers that the CCP has applied or intends to apply recovery measures which could prevent the CCP\u2019s failure but cause significant adverse effects to the financial system of the Union or of one of more of its Member States. 6. ESMA shall issue guidelines to promote the convergence of supervisory and resolution practices regarding the application of the circumstances under which a CCP is deemed to be failing or likely to fail by 12 February 2022, taking into consideration, as appropriate, the nature, and complexity of the services provided by CCPs established in the Union. When developing those guidelines, ESMA shall take into account the guidelines issued in accordance with Article 32(6) of Directive 2014/59/EU. Article 23 General principles regarding resolution 1. The resolution authority shall take all appropriate measures to apply the resolution tools referred to in Article 27 and exercise the resolution powers referred to in Article 48 in accordance with the following principles: (a) all contractual obligations and other arrangements in the CCP\u2019s recovery plan are enforced, to the extent that they have not been exhausted before entry into resolution, unless the resolution authority determines that in order to achieve the resolution objectives in a timely manner any of the following or both are more appropriate: (i) to refrain from enforcing certain contractual obligations under the CCP\u2019s recovery plan or otherwise deviate from it; (ii) to apply resolution tools or exercise the resolution powers; (b) the shareholders of the CCP under resolution bear first losses following the enforcement of all obligations and arrangements referred to in point (a) and in accordance with that point; (c) creditors of the CCP under resolution bear losses after the shareholders in accordance with the order of priority of their claims under normal insolvency proceedings, unless expressly provided otherwise in this Regulation; (d) the CCP\u2019s creditors of the same class are treated in an equitable manner; (e) the CCP\u2019s shareholders, clearing members and other creditors should not incur greater losses than they would have incurred in the circumstances referred to in Article 60; (f) the board and senior management of the CCP under resolution are replaced, except where the resolution authority considers that the retention of the board and senior management, in whole or in part, is necessary for the achievement of the resolution objectives; (g) resolution authorities inform and consult employee representatives in accordance with their national laws, collective agreements or practice; (h) resolution tools are applied and resolution powers are exercised without prejudice to provisions on the representation of employees in management bodies as provided for in national laws, collective agreements or practice; and (i) where a CCP is part of a group, resolution authorities take account of the impact on other group entities, in particular where such group comprises other FMIs, and on the group as a whole. 2. Resolution authorities may take a resolution action which deviates from the principles set out in points (d) or (e) of paragraph 1 of this Article where it is justified in the public interest to achieve the resolution objectives and is proportionate to the risk addressed. However, where that deviation results in a shareholder, a clearing member or any other creditor incurring greater losses than it would have incurred in the circumstances referred to in Article 60, the entitlement to payment of the difference under Article 62 shall apply. 3. The board and senior management of a CCP under resolution shall provide the resolution authority with all necessary assistance for the achievement of the resolution objectives. CHAPTER II Valuation Article 24 Objectives of valuation 1. Resolution authorities shall ensure that any resolution action is taken on the basis of a valuation ensuring a fair, prudent and realistic assessment of the assets, liabilities, rights and obligations of the CCP. 2. Before the resolution authority places a CCP under resolution, it shall ensure that a first valuation is carried out to determine whether the conditions for resolution under Article 22(1) are met. 3. After the resolution authority has decided to place a CCP under resolution, it shall ensure that a second valuation is carried out to: (a) inform the decision on the appropriate resolution action to be taken; (b) ensure that any losses on the assets and rights of the CCP are fully recognised at the moment the resolution tools are applied; (c) inform the decision on the extent of the cancellation or dilution of instruments of ownership and the decision on the value and number of instruments of ownership issued or transferred as a result of the exercise of resolution powers; (d) inform the decision on the extent of the write-down or conversion of any unsecured liabilities, including debt instruments; (e) where the loss and position allocation tools are applied, inform the decision on the extent of losses to be applied against affected creditors\u2019 claims, outstanding obligations or positions in relation to the CCP and on the extent and necessity of a resolution cash call; (f) where the bridge CCP tool is applied, inform the decision on the assets, liabilities, rights and obligations or instruments of ownership that may be transferred to the bridge CCP and the decision on the value of any consideration that may be paid to the CCP under resolution or, where relevant, to the holders of the instruments of ownership; (g) where the sale of business tool is applied, inform the decision on the assets, liabilities, rights and obligations or instruments of ownership that may be transferred to the third party purchaser and to inform the resolution authority\u2019s understanding of what constitutes commercial terms for the purposes of Article 40. For the purposes of point (d), the valuation shall take into account any losses that would be absorbed by the enforcement of any outstanding obligations of the clearing members or other third parties owed to the CCP and the level of conversion to be applied to debt instruments. 4. The valuations referred to in paragraphs 2 and 3 of this Article may be subject to an appeal in accordance with Article 74 only together with the decision to apply a resolution tool or to exercise a resolution power. Article 25 Requirements for valuation 1. The resolution authority shall ensure that the valuations referred to in Article 24 are carried out: (a) by a person independent from any public authority and from the CCP; or (b) by the resolution authority, where those valuations cannot be carried out by a person as referred to in point (a). 2. The valuations referred to in Article 24 shall be considered definitive where they are carried out by the person referred to in point (a) of paragraph 1 of this Article and all the requirements laid down in this Article are fulfilled. 3. Without prejudice to the Union State aid framework, where applicable, a definitive valuation shall be based on prudent assumptions and shall not assume any potential provision of extraordinary public financial support, any central bank emergency liquidity assistance or any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms to the CCP from the point in time at which resolution action is taken. The valuation shall also take account of the potential recovery of any reasonable expenses incurred by the CCP under resolution in accordance with Article 27(10). 4. A definitive valuation shall be supplemented by the following information held by the CCP: (a) an updated balance sheet and a report on the financial position of the CCP, including the remaining available pre-funded resources and outstanding financial commitments; (b) the records of cleared contracts referred to in Article 29 of Regulation (EU) No 648/2012; and (c) any information on the market and accounting values of its assets, liabilities and positions, including relevant claims and outstanding obligations owed or due to the CCP. 5. A definitive valuation shall indicate the subdivision of the creditors in classes in accordance with their priority levels under the applicable insolvency law. It shall also include an estimate of the treatment that each class of shareholders and creditors would have been expected to receive in application of the principle specified in point (e) of Article 23(1). The estimate referred to in the first subparagraph shall not prejudice the valuation referred to in Article 61. 6. ESMA, taking into account the regulatory technical standards developed in accordance with Article 36(14) and (15) of Directive 2014/59/EU and adopted pursuant to Article 36(16) thereof, shall develop draft regulatory technical standards to specify: (a) the circumstances in which a person is deemed to be independent from both the resolution authority and from the CCP for the purposes of paragraph 1 of this Article; (b) the methodology for assessing the value of the assets and liabilities of the CCP; and (c) the separation of the valuations under Articles 24 and 61 of this Regulation. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 26 Provisional valuation 1. The valuations referred to in Article 24 that do not meet the requirements laid down in Article 25(2) shall be considered to be provisional valuations. Provisional valuations shall include a buffer for additional losses and an appropriate justification for that buffer. 2. Where resolution authorities take resolution action on the basis of a provisional valuation, they shall ensure that a definitive valuation is carried out as soon as practicable. The resolution authority shall ensure that the definitive valuation referred to in the first subparagraph: (a) allows for full recognition of any losses of the CCP in its books; (b) informs a decision to write back creditors\u2019 claims or to increase the value of the consideration paid, in accordance with paragraph 3. 3. Where the definitive valuation\u2019s estimate of the net asset value of the CCP is higher than the provisional valuation\u2019s estimate of the net asset value of the CCP, the resolution authority may: (a) increase the value of the claims of affected creditors which have been written down or restructured; (b) require a bridge CCP to make a further payment of consideration in respect of the assets, liabilities, rights and obligations to the CCP under resolution or, as the case may be, in respect of the instruments of ownership to the owners of those instruments. 4. ESMA, taking into account the regulatory technical standards developed in accordance with Article 36(15) of Directive 2014/59/EU and adopted pursuant to Article 36(16) thereof, shall develop draft regulatory technical standards to specify, for the purposes of paragraph 1 of this Article, the methodology for calculating the buffer for additional losses to be included in provisional valuations. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. CHAPTER III Resolution tools Section 1 General principles Article 27 General provisions on resolution tools 1. Resolution authorities shall take resolution actions referred to in Article 21 by applying any of the following resolution tools individually or in any combination: (a) the position and loss allocation tools; (b) the write-down and conversion tool; (c) the sale of business tool; (d) the bridge CCP tool. 2. In the event of a systemic crisis, a Member State may as a last resort provide extraordinary public financial support by applying government stabilisation tools in accordance with Articles 45, 46 and 47 on the condition of prior and final approval under the Union State aid framework and where credible arrangements for the timely and comprehensive recovery of the funds in accordance with paragraph 10 of this Article are provided for. 3. Prior to the application of the tools referred to in paragraph 1, the resolution authority shall enforce: (a) any existing and outstanding rights of the CCP, including any contractual obligations by clearing members to meet recovery cash calls, to provide additional resources to the CCP, or to take on positions of defaulting clearing members, whether through an auction or other agreed means in the CCP\u2019s operating rules; (b) any existing and outstanding contractual obligation committing parties other than clearing members to any forms of financial support. The resolution authority may partially enforce the contractual obligations referred to in points (a) and (b) where it is not possible to enforce those contractual obligations in full within a reasonable timeframe. 4. By way of derogation from paragraph 3, the resolution authority may refrain from enforcing the relevant existing and outstanding obligations either partially or in full to avoid significant adverse effects on the financial system or widespread contagion, or where the application of the tools referred to in paragraph 1 is more appropriate in order to achieve the resolution objectives in a timely manner. 5. In the event that the resolution authority refrains partially or fully from enforcing existing and outstanding obligations as set out in the second subparagraph of paragraph 3 or in paragraph 4 of this Article, the resolution authority may enforce the remaining obligations within 18 months after the CCP is considered to be failing or likely to fail in accordance with Article 22, provided that the reasons for refraining from enforcing those obligations no longer exist. The resolution authority shall notify the clearing member and other party three to six months before enforcing the remaining obligation. The proceeds from the enforced remaining obligations shall be used to recover the use of public funds. The resolution authority shall, after consultation with the competent authorities and resolution authorities of the affected clearing members and any other parties committed by existing and outstanding obligations, determine whether the reasons for refraining from enforcing the existing and outstanding obligations have ceased to exist and whether to enforce remaining obligations. Where the resolution authority deviates from the views expressed by the authorities consulted, it shall provide duly justified reasons, in writing, for doing so. The requirement to meet the remaining obligations in the circumstances referred to in this paragraph shall be included in the CCP\u2019s rules and other contractual arrangements. 6. The resolution authority may require the CCP to compensate non-defaulting clearing members for their losses stemming from the application of loss allocation tools, where those losses are in excess of the losses that the non-defaulting clearing member would have borne under their obligations under the CCP\u2019s operating rules, provided that the non-defaulting clearing member would have been entitled to the payment of the difference referred to in Article 62. The compensation referred to in the first subparagraph may take the form of instruments of ownership, debt instruments or instruments recognising a claim on the CCP\u2019s future profits. The amount of instruments issued to each affected non-defaulting clearing member shall be proportionate to the excess loss referred to in the first subparagraph. It shall take account of any outstanding contractual obligations of the clearing members toward the CCP and be deducted from any entitlement to the payment of the difference referred to in Article 62. The amount of instruments shall be based on the valuation conducted in accordance with Article 24(3). 7. Where one of the government stabilisation tools is applied, the resolution authority shall exercise the power to write down and convert any instruments of ownership and debt instruments or other unsecured liabilities before or together with the application of the government stabilisation tool. Where the application of a resolution tool other than the write-down and conversion tool results in financial losses being borne by clearing members, the resolution authority shall exercise the power to write down and convert any instruments of ownership and debt instruments or other unsecured liabilities immediately before or together with the application of the resolution tool, unless applying a different sequence would minimise deviations from the \u2018no creditor worse off\u2019 principle set out in Article 60 and better achieve the resolution objectives. 8. Where only the resolution tools referred to in points (c) and (d) of paragraph 1 of this Article are applied, and only part of the assets, rights, obligations or liabilities of the CCP under resolution are transferred in accordance with Articles 40 and 42, the residual part of that CCP shall be wound up in accordance with normal insolvency proceedings. 9. National insolvency law rules relating to the voidability or unenforceability of legal acts detrimental to creditors shall not apply to transfers of assets, rights, obligations or liabilities from a CCP in relation to which resolution tools or government financial stabilisation tools are applied. 10. Member States shall recover over an appropriate period any public funds used as government financial stabilisation tools as referred to in Section 7 of this Chapter and resolution authorities shall recover any reasonable expenses incurred by them in connection with the application of the resolution tools or powers. Such recovery shall, inter alia, come from: (a) the CCP under resolution, as a preferred creditor, including any of its claims against defaulting clearing members; (b) any consideration paid by the purchaser to the CCP, as a preferred creditor prior to the application of Article 40(4), where the sale of business tool has been applied; (c) any proceeds generated as a result of the termination of the bridge CCP, as a preferred creditor prior to the application of Article 42(5); (d) any proceeds generated by the application of the public equity support tool referred to in Article 46 and the temporary public ownership tool referred to in Article 47, including the proceeds generated from their sale. 11. When applying the resolution tools, resolution authorities shall ensure, on the basis of a valuation that complies with Article 25, the restoration of a matched book, the full allocation of losses, the replenishment of the pre-funded resources of the CCP or the bridge CCP, and the recapitalisation of the CCP or the bridge CCP. Resolution authorities shall ensure the replenishment of the pre-funded resources and the recapitalisation of the CCP or the bridge CCP as referred to in the first subparagraph, to an extent sufficient to restore the ability of the CCP or the bridge CCP to comply with the conditions for authorisation and to continue to carry out the critical functions of the CCP or the bridge CCP, taking into account the operating rules of the CCP or the bridge CCP. Notwithstanding the application of other resolution tools, resolution authorities may apply the tools referred to in Articles 30 and 31 to recapitalise the CCP. Section 2 Position allocation and loss allocation tools Article 28 Objective and scope of the position and loss allocation tools 1. Resolution authorities shall apply the position allocation tool in accordance with Article 29 and the loss allocation tools in accordance with Articles 30 and 31. 2. Resolution authorities shall apply the tools referred to in paragraph 1 in respect of contracts relating to clearing services and the collateral related to those services posted to the CCP. 3. Resolution authorities shall apply the position allocation tool referred to in Article 29 in order to rematch the book of the CCP or bridge CCP where relevant. Resolution authorities shall apply the loss allocation tools referred to in Articles 30 and 31 for any of the following purposes: (a) to cover the losses of the CCP assessed in accordance with Article 25; (b) to restore the ability of the CCP to meet payment obligations as they fall due; (c) to achieve the outcome referred to in points (a) and (b) in relation to a bridge CCP; (d) to support the transfer of the CCP\u2019s business by way of the sale of business tool to a solvent third party. The loss allocation tool referred to in Article 30 may be applied by the resolution authorities in relation to losses arising from a default event and in relation to losses arising from a non-default event. If the loss allocation tool referred to in Article 30 is applied in relation to losses arising from a non-default event, it shall only be applied up to a cumulative amount equivalent to the non-defaulting clearing members\u2019 contribution to the CCP\u2019s default funds and distributed among clearing members proportionally to their contributions to the default funds. 4. Resolution authorities shall not apply the loss allocation tools referred to in Articles 30 and 31 of this Regulation with regard to the entities referred to in Articles 1(4) and 1(5) of Regulation (EU) No 648/2012. Article 29 Termination of contracts \u2013 partial or full 1. The resolution authority may terminate some or all of the following contracts of the CCP under resolution: (a) the contracts with the clearing member in default; (b) the contracts of the affected clearing service or asset class; (c) the other contracts of the CCP under resolution. The resolution authority shall terminate the contracts referred to in point (a) of the first subparagraph of this paragraph only where the transfer of the assets and positions resulting from those contracts has not taken place within the meaning of Article 48(5) and (6) of Regulation (EU) No 648/2012. When using the power under the first subparagraph, the resolution authority shall terminate contracts referred to under each of points (a), (b) and (c) of the first subparagraph in a similar way, without discriminating between counterparties to those contracts, with the exception of those contractual obligations that cannot be enforced in a reasonable timeframe. 2. The resolution authority shall give notice to all relevant clearing members of the date on which any contract referred to in paragraph 1 is terminated. 3. Prior to the termination of any of the contracts referred to in paragraph 1, the resolution authority shall take the following steps: (a) require the CCP under resolution to value each contract, and update the account balances of each clearing member; (b) determine the net amount payable by or to each clearing member, taking account of any due but unpaid variation margin, including variation margin due as a result of the contract valuations referred to in point (a); and (c) notify each clearing member of the determined net amounts and require the CCP to pay or collect them accordingly. The clearing members shall, without undue delay, communicate the application of such tool to their clients and the way in which such application affects them. 4. The valuation referred in point (a) of paragraph 3 shall be based, as far as possible, on a fair market price determined on the basis of the CCP\u2019s own rules and arrangements, unless the resolution authority deems necessary the use of another appropriate price discovery method. 5. Where a non-defaulting clearing member is unable to pay the net amount determined in accordance with paragraph 3 of this Article, the resolution authority may, having regard to Article 21 of this Regulation, require the CCP to place the non-defaulting clearing member in default and use its initial margin and default fund contribution in accordance with Article 45 of Regulation (EU) No 648/2012. 6. Where the resolution authority has terminated one or more contracts of the types referred to in paragraph 1, it may temporarily prevent the CCP from clearing any new contract of the same type as the one terminated. The resolution authority may allow the CCP to resume the clearing of those types of contracts only where the following conditions are met: (a) the CCP complies with the requirements of Regulation (EU) No 648/2012; and (b) the resolution authority issues and publishes a notice to that effect using the means referred to in Article 72(3). 7. ESMA shall by 12 February 2022 issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 further specifying the methodology to be used by the resolution authority for determining the valuation referred in point (a) of paragraph 3 of this Article. Article 30 Reduction of the value of any gains payable by the CCP to non-defaulting clearing members 1. The resolution authority may reduce the amount of the CCP\u2019s payment obligations to non-defaulting clearing members where those obligations arise from gains due in accordance with the CCP\u2019s processes for paying variation margin or a payment that has the same economic effect. 2. The resolution authority shall calculate any reduction in payment obligations referred to in paragraph 1 of this Article using an equitable allocation mechanism determined in the valuation conducted in accordance with Article 24(3) and communicated to the clearing members as soon as the resolution tool is applied. The clearing members shall, without undue delay, communicate the application of such tool to their clients and the way in which such application affects them. The total net gains to be reduced for each clearing member shall be proportional to the amounts due from the CCP. 3. The reduction in the value of gains payable shall take effect and shall be immediately binding on the CCP and affected clearing members from the moment at which the resolution authority takes the resolution action. 4. A non-defaulting clearing member shall not have any claim in any subsequent proceedings against the CCP, or its successor entity, arising from the reduction in payment obligations referred to in paragraph 1. The first subparagraph of this paragraph shall not prevent resolution authorities from requiring the CCP to reimburse clearing members, where the level of reduction based on the provisional valuation referred to in Article 26(1) is found to exceed the level of reduction required based on the definitive valuation referred to in Article 26(2). 5. Where a resolution authority reduces only in part the value of gains payable, the residual outstanding payable amount shall still be owed to the non-defaulting clearing member. 6. The CCP shall include in its operating rules reference to the power to reduce payment obligations referred to in paragraph 1 in addition to any similar arrangements provided for in those operating rules at the recovery stage and shall ensure that contractual arrangements are concluded to allow the resolution authority to exercise its powers under this Article. Article 31 Resolution cash call 1. The resolution authority may require non-defaulting clearing members to make a contribution in cash to the CCP up to twice the amount equivalent to their contribution to the CCP\u2019s default fund. This obligation to make a contribution in cash shall also be included in the CCP\u2019s rules and other contractual arrangements as a resolution cash call reserved to the resolution authority taking resolution action. Where the resolution authority calls for an amount in excess of the contribution to the default fund, it shall do so after assessing the impact of this tool on non-defaulting clearing members and the financial stability of Member States, in cooperation with the resolution authorities of non-defaulting clearing members. Where the CCP operates multiple default funds and the tool is applied to address a default event, the amount of the contribution in cash referred to in the first subparagraph shall refer to the contribution of the clearing member to the default fund of the affected clearing service or asset class. Where the CCP operates multiple default funds and the tool is applied to address a non-default event, the amount of the contribution in cash referred to in the first subparagraph shall refer to the sum of the contributions of the clearing member to all default funds of the CCP. The resolution authority may exercise the resolution cash call regardless of whether all contractual obligations requiring cash contributions from non-defaulting clearing members have been exhausted. The resolution authority shall determine the amount of the cash contribution of each non-defaulting clearing member in proportion to its contribution to the default fund up to the limit referred in the first subparagraph. The resolution authority may require the CCP to reimburse clearing members the possible excess amount of a resolution cash call where the level of the resolution cash call applied based on a provisional valuation according to Article 26(1) is found to exceed the required level based on the definitive valuation referred to in Article 26(2). 2. If a non-defaulting clearing member does not pay the required amount, the resolution authority may require the CCP to place that clearing member in default and use its initial margin and default fund contribution in accordance with Article 45 of Regulation (EU) No 648/2012 up to the required amount. Section 3 Write-down and conversion of instruments of ownership and debt instruments or other unsecured liabilities Article 32 Requirement to write down and convert instruments of ownership and debt instruments or other unsecured liabilities 1. The resolution authority shall apply the write-down and conversion tool in accordance with Article 33 in respect of instruments of ownership and debt instruments issued by the CCP under resolution or other unsecured liabilities in order to absorb losses, recapitalise that CCP or a bridge CCP, or to support the application of the sale of business tool. 2. Based on the valuation carried out in accordance with Article 24(3), the resolution authority shall determine the following: (a) the amount by which the instruments of ownership and debt instruments or other unsecured liabilities must be written down taking into account any losses that are to be absorbed by the enforcement of any outstanding obligations of the clearing members or other third parties owed to the CCP; and (b) the amount by which debt instruments or other unsecured liabilities must be converted into instruments of ownership in order to restore the capital requirements of the CCP or the bridge CCP. Article 33 Provisions governing the write-down or conversion of instruments of ownership and debt instruments or other unsecured liabilities 1. The resolution authority shall apply the write-down and conversion tool in accordance with the priority of claims applicable under normal insolvency proceedings. 2. Prior to reducing or converting the principal amount of debt instruments or other unsecured liabilities, the resolution authority shall reduce the nominal amount of instruments of ownership in proportion to the losses and up to their full value, where necessary. Where, in accordance with the valuation carried out pursuant to Article 24(3), the CCP maintains a positive net value after the reduction of the nominal amount of instruments of ownership, the resolution authority shall cancel or dilute, as the case may be, those instruments of ownership. 3. The resolution authority shall reduce, convert, or both, the principal amount of debt instruments or other unsecured liabilities to the extent required to achieve the resolution objectives, and up to the full value of those instruments or liabilities, where necessary. 4. The resolution authority shall not apply the write-down and conversion tool in respect of the following liabilities: (a) liabilities to employees, in relation to accrued salary, pension benefits or other fixed remuneration, except for any variable component of remuneration that is not regulated by a collective bargaining agreement; (b) liabilities to commercial or trade creditors arising from the provision to the CCP of goods or services that are critical to the daily functioning of its operations, including IT services, utilities and the rental, servicing and upkeep of premises; (c) liabilities to tax and social security authorities, provided that those liabilities are preferred liabilities under the applicable insolvency law; (d) liabilities owed to systems or operators of systems designated according to Directive 98/26/EC, to participants to the extent that the liabilities result from their participation in such systems, to other CCPs, and to central banks; (e) initial margins. 5. Where the nominal amount of an instrument of ownership or the principal amount of a debt instrument or other unsecured liabilities is reduced, the following conditions shall apply: (a) that reduction shall be permanent; (b) the holder of the instrument shall have no claim in connection with that reduction, except for any liability already accrued, any liability for damages that may arise as a result of an appeal challenging the legality of that reduction, any claim based on instruments of ownership issued or transferred pursuant to paragraph 6 of this Article, or any claim for payment in accordance with Article 62; and (c) where that reduction is only partial, the agreement that created the original liability shall continue to apply in respect of the residual amount subject to any necessary amendments of the terms of that agreement due to the reduction. Point (a) of the first subparagraph shall not prevent resolution authorities from applying a write-up mechanism to reimburse holders of debt instruments or other unsecured liabilities and then holders of instruments of ownership, where the level of write-down applied based on the provisional valuation referred to in Article 26(1) is found to exceed the amounts required based on the definitive valuation referred to in Article 26(2). 6. Where converting debt instruments or other unsecured liabilities pursuant to paragraph 3, the resolution authority may require the CCP to issue or to transfer instruments of ownership to the holders of the debt instruments or other unsecured liabilities. 7. The resolution authority shall only convert debt instruments or other unsecured liabilities pursuant to paragraph 3 where the following conditions are met: (a) the instruments of ownership are issued prior to any issuance of instruments of ownership by the CCP for the purposes of provision of own funds by the State or a government entity; and (b) the conversion rate represents appropriate compensation to the affected debt holders for any loss incurred as a result of the exercise of the write-down and conversion powers, in line with their treatment under normal insolvency proceedings. Following any conversion of debt instruments or other unsecured liabilities to instruments of ownership, the latter shall be subscribed or transferred without delay after the conversion. 8. For the purposes of paragraph 7, the resolution authority shall ensure, in the context of drawing up and maintaining the CCP\u2019s resolution plan and as part of the powers to remove impediments to the resolvability of the CCP, that the CCP is at all times able to issue the necessary number of instruments of ownership. Article 34 Effect of write-down and conversion The resolution authority shall complete or require the completion of all the administrative and procedural tasks necessary to give effect to the application of the write-down and conversion tool, including: (a) the amendment of all relevant registers; (b) the delisting or removal from trading of instruments of ownership or debt instruments; (c) the listing or admission to trading of new instruments of ownership; and (d) the relisting or readmission of any debt instruments which have been written down, without the requirement for the issuing of a prospectus in accordance with Regulation (EU) 2017/1129 of the European Parliament and of the Council (24). Article 35 Removal of procedural obstacles for write-down and conversion 1. Where Article 32(1) is applied, the competent authority shall require the CCP to maintain at all times a sufficient amount of instruments of ownership to ensure that the CCP may issue sufficient new instruments of ownership and that the issuance of or conversion into instruments of ownership could be carried out effectively. 2. The resolution authority shall apply the write-down and conversion tool regardless of any provisions in the CCP\u2019s instruments of incorporation or statutes, including with respect to pre-emption rights for shareholders or requirements for the consent of shareholders to an increase of capital. Article 36 Submission of a business reorganisation plan 1. CCPs shall, within one month after the application of the tools referred to in Article 32, conduct a review of the causes of its failure and submit it to the resolution authority alongside a business reorganisation plan in accordance with Article 37. Where the Union State aid framework is applicable, that plan, including following any amendments in accordance with Article 38 and as implemented in accordance with Article 39, shall be compatible with the restructuring plan that the CCP is required to submit to the Commission in accordance with that framework. Where necessary for achieving the resolution objectives, the resolution authority may extend the period referred to in the first subparagraph up to a maximum of two months. 2. Where a restructuring plan is required to be notified under the Union State aid framework, the submission of the business reorganisation plan shall be without prejudice to the deadline laid down by that framework for the submission of that restructuring plan. 3. The resolution authority shall submit the review and the business reorganisation plan, and any revised plan in accordance with Article 38, to the competent authority and to the resolution college. Article 37 Content of the business reorganisation plan 1. The business reorganisation plan referred to in Article 36 shall set out measures aiming to restore the long-term viability of the CCP or parts of its business within a reasonable timeframe. Those measures shall be based on realistic assumptions as to the economic and financial market conditions under which the CCP will operate. The business reorganisation plan shall take account of the current and potential states of the financial markets and reflect best-case and worst-case assumptions, including a combination of events to identify the CCP\u2019s main vulnerabilities. Assumptions shall be compared with appropriate sector-wide benchmarks. 2. The business reorganisation plan shall include at least the following elements: (a) a detailed analysis of the factors and circumstances that caused the CCP to fail or to be likely to fail; (b) a description of the measures to be adopted to restore the CCP\u2019s long-term viability; and (c) a timetable for the implementation of those measures. 3. Measures aiming to restore the long-term viability of a CCP may include: (a) the reorganisation and restructuring of the activities of the CCP; (b) changes to the CCP\u2019s operational systems and infrastructure; (c) the sale of assets or of business lines; (d) changes to the CCP\u2019s risk management. 4. ESMA shall by 12 February 2023 develop draft regulatory technical standards to specify further the minimum elements that should be included in a business reorganisation plan pursuant to paragraph 2. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 38 Assessment and adoption of the business reorganisation plan 1. Within one month of the submission of the business reorganisation plan by the CCP pursuant to Article 36(1), the resolution authority and the competent authority shall assess whether the measures provided for in that plan would reliably restore the long-term viability of the CCP. Where the resolution authority and the competent authority are satisfied that the plan would restore the CCP\u2019s long-term viability, the resolution authority shall approve the plan. 2. Where the resolution authority or the competent authority are not satisfied that the measures provided for in the plan would restore the CCP\u2019s long-term viability, the resolution authority shall notify the CCP of their concerns and require it to resubmit an amended plan addressing those concerns within two weeks of the notification. 3. The resolution authority and the competent authority shall assess the resubmitted plan and the resolution authority shall notify the CCP within one week of the reception of that plan whether the concerns are appropriately addressed or whether further amendments are required. 4. ESMA shall by 12 February 2023 develop draft regulatory technical standards to specify the criteria that a business reorganisation plan is to fulfil for approval by the resolution authority pursuant to paragraph 1. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 39 Implementation and monitoring of the business reorganisation plan 1. The CCP shall implement the business reorganisation plan and shall submit a report to the resolution authority and the competent authority as requested and, at least, every six months on its progress in implementing that plan. 2. The resolution authority, in agreement with the competent authority, may require the CCP to revise the plan where necessary to achieve the aim referred to in Article 37(1). Section 4 Sale of business tool Article 40 Sale of business tool 1. The resolution authority may transfer the following to a purchaser that is not a bridge CCP: (a) instruments of ownership issued by a CCP under resolution; (b) any assets, rights, obligations or liabilities of a CCP under resolution. The transfer referred to in the first subparagraph shall take place without obtaining the consent of the shareholders of the CCP, or any third party other than the purchaser and without complying with any procedural requirements under company or securities law other than those provided for in Article 41. 2. A transfer made pursuant to paragraph 1 shall be made on commercial terms, having regard to the circumstances, and in accordance with the Union State aid framework. For the purposes of the first subparagraph of this paragraph, the resolution authority shall take all reasonable steps to obtain commercial terms that conform to the valuation conducted under Article 24(3). 3. Subject to Article 27(10), any consideration paid by the purchaser shall benefit: (a) the owners of the instruments of ownership where the sale of business has been effected by transferring instruments of ownership issued by the CCP under resolution from the holders of those instruments to the purchaser; (b) the CCP under resolution, where the sale of business has been effected by transferring some or all of the assets or liabilities of the CCP to the purchaser; (c) any non-defaulting clearing members that have suffered losses resulting from the application of the resolution tools in resolution, proportionate to their losses in resolution. 4. The allocation of any consideration paid by the purchaser in accordance with paragraph 3 of this Article shall be carried out as follows: (a) upon the occurrence of an event covered by the CCP\u2019s default waterfall as set out in Articles 43 and 45 of Regulation (EU) No 648/2012, in a reversal of the order in which the losses have been imposed by the CCP\u2019s default waterfall; or (b) upon the occurrence of an event not covered by the CCP\u2019s default waterfall as set out in Articles 43 and 45 of Regulation (EU) No 648/2012, in a reversal of the order in which the losses were allocated in accordance with any applicable rules of the CCP. The allocation of any remaining consideration shall then be carried out in accordance with the priority of claims under normal insolvency proceedings. 5. The resolution authority may exercise the transfer power referred to in paragraph 1 more than once in order to make supplemental transfers of instruments of ownership issued by the CCP or, as the case may be, the CCP\u2019s assets, rights, obligations, or liabilities. 6. The resolution authority may, with the consent of the purchaser, transfer the assets, rights, obligations or liabilities that had been transferred to the purchaser back to the CCP under resolution, or the instruments of ownership back to their original owners. Where the resolution authority uses the transfer power referred to in the first subparagraph, the CCP under resolution or original owners shall be obliged to take back any such assets, rights, obligations or liabilities, or instruments of ownership. 7. Any transfer made pursuant to paragraph 1 shall take place irrespective of whether the purchaser is authorised to provide the services and carry out the activities resulting from the acquisition. Where the purchaser is not authorised to provide the services and carry out the activities resulting from the acquisition, the resolution authority, in consultation with the competent authority, shall conduct an appropriate due diligence assessment of the purchaser and ensure that the purchaser has the professional and technical capacity to perform the functions of the purchased CCP and that it applies for authorisation as soon as practicable and, at the latest, within one month of the application of the sale of business tool. The competent authority shall ensure that any such application for authorisation is considered in an expedited manner. 8. Where the transfer of instruments of ownership referred to in paragraph 1 of this Article results in the acquisition of or increase in a qualifying holding referred to in Article 31(2) of Regulation (EU) No 648/2012, the competent authority shall carry out the assessment referred to in that Article within a period that neither delays the application of the sale of business tool nor prevents the resolution action from achieving the relevant resolution objectives. 9. Where the competent authority has not completed the assessment referred to in paragraph 8 by the date on which the transfer of instruments of ownership takes effect, the following shall apply: (a) the transfer of instruments of ownership shall have immediate legal effect from the date on which they are transferred; (b) during the assessment period and during any divestment period provided for in point (f) of this paragraph, the purchaser\u2019s voting rights attached to those instruments of ownership shall be suspended and vested solely in the resolution authority, which shall have no obligation to exercise them and, unless the act or omission implies gross negligence or serious misconduct, shall not be liable for exercising or refraining from exercising them; (c) during the assessment period and during any divestment period provided for in point (f) of this paragraph, any penalties provided for in Article 22(3) of Regulation (EU) No 648/2012 or measures for infringing the requirements for acquisitions or disposals of qualifying holdings provided for in Article 30 of Regulation (EU) No 648/2012 shall not apply to that transfer; (d) the competent authority shall notify the resolution authority and the purchaser in writing of the result of its assessment in accordance with Article 32 of Regulation (EU) No 648/2012 promptly after completing its assessment; (e) where the competent authority does not oppose the transfer, the voting rights attached to those instruments of ownership shall be deemed to be fully vested in the purchaser as from the notification referred to in point (d) of this paragraph; (f) where the competent authority opposes the transfer of instruments of ownership, point (b) shall continue to apply and the resolution authority may, having taken into account market conditions, establish a divestment period within which the purchaser shall divest such instruments of ownership. 10. For the purposes of exercising its right to provide services in accordance with Regulation (EU) No 648/2012, the purchaser shall be considered to be a continuation of the CCP under resolution, and may continue to exercise any such right that was exercised by the CCP under resolution in respect of the assets, rights, obligations or liabilities transferred. 11. The purchaser referred to in paragraph 1 shall not be prevented from exercising the CCP\u2019s rights of membership and accessing the payment and settlement systems and other linked FMIs and trading venues provided that the purchaser meets the criteria for membership or participation in those systems or infrastructures or trading venues. Notwithstanding the first subparagraph, the purchaser shall not be denied access to payment and settlement systems, and other linked FMIs and trading venues, on the ground that the purchaser does not possess a rating from a credit rating agency, or that that rating is below the rating levels required to be granted access to those systems or infrastructures or trading venues. Where the purchaser does not meet the criteria referred to in the first subparagraph, the purchaser may continue to exercise the CCP\u2019s rights of membership and accessing those systems and other infrastructures and trading venues for the period specified by the resolution authority. That period shall not exceed 12 months. 12. Unless otherwise provided for in this Regulation, shareholders, creditors, clearing members and clients of the CCP under resolution and other third parties whose assets, rights, obligations or liabilities are not transferred shall have no rights over, or in relation to, the assets, rights, obligations or liabilities transferred. Article 41 Sale of business tool: procedural requirements 1. Where applying the sale of business tool in relation to a CCP, the resolution authority shall advertise the availability, or make arrangements for the marketing, of the assets, rights, obligations, liabilities, or the instruments of ownership intended to be transferred. Pools of rights, assets, obligations and liabilities may be marketed separately. 2. Without prejudice to the Union State aid framework, where applicable, the marketing referred to in paragraph 1 shall be carried out in accordance with the following criteria: (a) it shall be as transparent as possible and not materially misrepresent the assets, rights, obligations, liabilities, or instruments of ownership of the CCP, having regard to the circumstances and in particular the need to maintain financial stability; (b) it shall not unduly favour or discriminate between potential purchasers; (c) it shall be free from any conflict of interest; (d) it shall take account of the need to effect a rapid resolution action; and (e) it shall aim to maximise, as far as possible, the sale price for the instruments of ownership, assets, rights, obligations or liabilities involved. The criteria referred to in the first subparagraph shall not prevent the resolution authority from soliciting particular potential purchasers. 3. By way of derogation from paragraphs 1 and 2, the resolution authority may apply the sale of business tool without complying with the requirement to market, or may market the assets, rights, obligations, liabilities or the instruments of ownership where it determines that compliance with that requirement or with those criteria would be likely to undermine one or more of the resolution objectives, including by creating a material threat to financial stability. Section 5 Bridge CCP tool Article 42 Bridge CCP tool 1. The resolution authority may transfer to a bridge CCP the following: (a) instruments of ownership issued by a CCP under resolution; (b) any assets, rights, obligations or liabilities of the CCP under resolution. The transfer referred to in the first subparagraph may take place without obtaining the consent of the shareholders of the CCP under resolution or any third party other than the bridge CCP and without complying with any procedural requirements under company or securities law other than those provided for in Article 43. 2. The bridge CCP shall be a legal person that: (a) is controlled by the resolution authority and is wholly or partially owned by one or more public authorities which may include the resolution authority; and (b) is established or used for the purpose of receiving and holding some or all of the instruments of ownership issued by a CCP under resolution or some or all of the assets, rights, obligations and liabilities of the CCP with a view to maintaining the critical functions of the CCP and subsequently selling the CCP. 3. When applying the bridge CCP tool, the resolution authority shall ensure that the total value of liabilities and obligations transferred to the bridge CCP does not exceed the total value of the rights and assets transferred from the CCP under resolution. 4. Subject to Article 27(10), any consideration paid by the bridge CCP shall benefit: (a) the owners of the instruments of ownership, where the transfer to the bridge CCP has been effected by transferring instruments of ownership issued by the CCP under resolution from the holders of those instruments to the bridge CCP; (b) the CCP under resolution, where the transfer to the bridge CCP has been effected by transferring some or all of the assets or liabilities of that CCP to the bridge CCP; (c) any non-defaulting clearing members that have suffered losses following the application of the resolution tools in resolution, proportionate to their losses in resolution. 5. The allocation of any consideration paid by the bridge CCP in accordance with paragraph 4 of this Article shall be carried out as follows: (a) upon the occurrence of an event covered by the CCP\u2019s default waterfall as set out in Articles 43 and 45 of Regulation (EU) No 648/2012, in a reversal of the order in which the losses have been imposed by the CCP\u2019s default waterfall; or (b) upon the occurrence of an event not covered by the CCP\u2019s default waterfall as set out in Articles 43 and 45 of Regulation (EU) No 648/2012, in a reversal of the order in which the losses were allocated in accordance with any applicable rules of the CCP. The allocation of any remaining consideration shall be carried out in accordance with the priority of claims under normal insolvency proceedings. 6. The resolution authority may exercise the transfer power referred to in paragraph 1 more than once in order to make supplemental transfers of instruments of ownership issued by a CCP or of its assets, rights, obligations or liabilities. 7. The resolution authority may transfer the rights, obligations, assets or liabilities that had been transferred to the bridge CCP back to the CCP under resolution, or the instruments of ownership back to their original owners where that transfer is expressly provided for in the instrument by which the transfer referred to in paragraph 1 is made. Where the resolution authority uses the transfer power referred to in the first subparagraph, the CCP under resolution or original owners shall be obliged to take back any such assets, rights, obligations or liabilities, or instruments of ownership, provided that the conditions in the first subparagraph of this paragraph or in paragraph 8 are met. 8. Where the specific instruments of ownership, assets, rights, obligations or liabilities do not fall within the classes of, or meet the conditions for transfer of, instruments of ownership, assets, rights, obligations or liabilities specified in the instrument by which the transfer was made, the resolution authority may transfer them from the bridge CCP back to the CCP under resolution or the original owners. 9. A transfer referred to in paragraphs 7 and 8 may be made at any time, and shall comply with any other conditions stated in the instrument by which the transfer was made for the relevant purpose. 10. The resolution authority may transfer instruments of ownership or assets, rights, obligations or liabilities from the bridge CCP to a third party. 11. For the purposes of exercising its right to provide services in accordance with Regulation (EU) No 648/2012, a bridge CCP shall be considered to be a continuation of the CCP under resolution and may continue to exercise any such right that was exercised by the CCP under resolution in respect of the assets, rights, obligations or liabilities transferred. For any other purposes, resolution authorities may require that a bridge CCP be considered to be a continuation of the CCP under resolution, and be able to continue to exercise any right that was exercised by the CCP under resolution in respect of the assets, rights, obligations or liabilities transferred. 12. The bridge CCP shall not be prevented from exercising the CCP\u2019s rights of membership and accessing payment and settlement systems and other linked FMIs and trading venues, provided that it meets the criteria for membership and participation in those systems or FMIs or trading venues. Notwithstanding the first subparagraph, the bridge CCP shall not be denied access to payment and settlement systems and other FMIs and trading venues on the ground that the bridge CCP does not possess a rating from a credit rating agency, or that that rating is below the rating levels required to be granted access to those systems or infrastructures or trading venues. Where the bridge CCP does not meet the criteria referred to in the first subparagraph, the bridge CCP may continue to exercise the CCP\u2019s rights of membership and accessing those systems and other infrastructures and trading venues for a period specified by the resolution authority. That period shall not exceed 12 months. 13. Shareholders, creditors, clearing members and clients of the CCP under resolution and other third parties whose assets, rights, obligations or liabilities are not transferred to the bridge CCP, shall have no rights over, or in relation to, the assets, rights, obligations or liabilities transferred to the bridge CCP, or against its board or senior management. 14. The bridge CCP shall have no duty or responsibility to shareholders or creditors of the CCP under resolution, and the board or senior management of the bridge CCP shall have no liability to those shareholders or creditors for acts and omissions in the discharge of their duties, unless the act or omission is due to gross negligence or serious misconduct in accordance with applicable national law. Article 43 Bridge CCP: procedural requirements 1. The bridge CCP shall comply with all of the following requirements: (a) the bridge CCP shall seek the approval of the resolution authority for all of the following: (i) the rules of incorporation of the bridge CCP; (ii) the members of the bridge CCP\u2019s board, where those members are not directly appointed by the resolution authority; (iii) the responsibilities and remuneration of the members of the bridge CCP\u2019s board, where the remuneration and the responsibilities are not determined by the resolution authority; and (iv) the strategy and risk profile of the bridge CCP; and (b) the bridge CCP shall take over the authorisations of the CCP under resolution to provide the services or carry out the activities resulting from the transfer referred to in Article 42(1) of this Regulation in accordance with Regulation (EU) No 648/2012. Notwithstanding point (b) of the first subparagraph and where necessary to meet the resolution objectives, the bridge CCP may be authorised without complying with Regulation (EU) No 648/2012 for a short period at the beginning of its operation. To that end, the resolution authority shall submit a request for such authorisation to the competent authority. If the competent authority decides to grant such authorisation, it shall indicate the period for which the bridge CCP\u2019s obligation to comply with the requirements of Regulation (EU) No 648/2012 is waived. That period shall not exceed 12 months. During that period, the bridge CCP shall be considered as a qualifying CCP as defined in point (88) of Article 4(1) of Regulation (EU) No 575/2013 for the purposes of that Regulation. Notwithstanding the period referred to in the second subparagraph, in the case of prudential requirements under Chapter 3 of Title IV of Regulation (EU) No 648/2012, the waiver shall only be for a period of up to three months. It may be extended for one or two further periods of up to three months if necessary to achieve the resolution objectives. 2. Subject to any restrictions imposed in accordance with Union or national competition rules, the management of the bridge CCP shall operate the bridge CCP with the objective of maintaining continuity of the bridge CCP\u2019s critical functions and selling the bridge CCP or any of its assets, rights, obligations and liabilities to one or more private sector purchasers. That sale shall take place when market conditions are appropriate, and within the period specified in paragraphs 5 and, where applicable, 6. 3. The resolution authority shall take a decision that the bridge CCP is no longer a bridge CCP within the meaning of Article 42(2) in any of the following cases: (a) the resolution objectives are fulfilled; (b) the bridge CCP merges with another entity; (c) the bridge CCP ceases to meet the requirements laid down in Article 42(2); (d) the bridge CCP or substantially all of its assets, rights, obligations or liabilities have been sold in accordance with paragraphs 2 and 4 of this Article; (e) the period specified in paragraph 5 of this Article or, where applicable, paragraph 6 of this Article expires; (f) the contracts cleared by the bridge CCP have been settled, have expired or have been closed out and the CCP\u2019s rights and obligations relating to those contracts are thereby completely discharged. 4. Before selling the bridge CCP or its assets, rights, obligations or liabilities, the resolution authority shall advertise the availability of the elements intended to be sold, and shall ensure that they are marketed openly and transparently, and that they are not materially misrepresented. The resolution authority shall carry out the sale referred to in the first subparagraph on commercial terms and shall not unduly favour or discriminate between potential purchasers. 5. The resolution authority shall terminate the operation of a bridge CCP two years after the date on which the last transfer from the CCP under resolution is made. Where the resolution authority terminates the operation of a bridge CCP, it shall request the competent authority to withdraw the bridge CCP\u2019s authorisation. 6. The resolution authority may extend the period referred to in paragraph 5 for one or more additional one-year periods where the extension is necessary to achieve the outcomes referred to in points (a) to (d) of paragraph 3. The decision to extend the period referred to in paragraph 5 shall be reasoned and shall contain a detailed assessment of the bridge CCP\u2019s situation in relation to relevant market conditions and market outlook. 7. Where the operations of a bridge CCP are terminated in the circumstances referred to in point (d) or (e) of paragraph 3, the bridge CCP shall be wound up under normal insolvency proceedings. Unless otherwise provided for in this Regulation, any proceeds generated as a result of the termination of the bridge CCP shall benefit its shareholders. Where a bridge CCP is used for the purpose of transferring assets and liabilities of more than one CCP under resolution, the proceeds referred to in the second subparagraph shall be attributed by reference to the assets and liabilities transferred from each of the CCPs under resolution. Section 6 Additional financing arrangements Article 44 Alternative funding means The resolution authority may enter into contracts to borrow or obtain other forms of financial support, including from pre-funded resources available in any non-depleted default funds in the CCP under resolution, where necessary to meet temporary liquidity needs in order to ensure the effective application of the resolution tools. Section 7 Government stabilisation tools Article 45 Government financial stabilisation tools 1. In the very extraordinary situation of a systemic crisis, Member States may apply the government stabilisation tools in accordance with Articles 46 and 47 for the purpose of resolving a CCP only where the following conditions are met: (a) the financial support is necessary to meet the resolution objectives referred to in Article 21; (b) the financial support is used only as a last resort in accordance with paragraph 3 of this Article after having assessed and exploited all resolution tools to the maximum extent practicable whilst maintaining financial stability; (c) the financial support is limited in time; (d) the financial support complies with the Union State aid framework; and (e) the Member State has, in advance, defined comprehensive and credible arrangements, in a manner consistent with the Union state aid framework, for recovering, over a suitable period, and in accordance with Article 27(10) the public funds deployed, to the extent not retrieved in full through the sale to private purchasers in accordance with Article 46(3) or 47(2). The application of government stabilisation tools shall be carried out in accordance with national law either under the leadership of the competent ministry or government in close cooperation with the resolution authority or under the leadership of the resolution authority. 2. To give effect to the government financial stabilisation tools, competent ministries or governments shall have the relevant resolution powers specified in Articles 48 to 58, and shall ensure that Articles 52, 54 and 72 are complied with. 3. Government financial stabilisation tools shall be deemed to be applied as a last resort for the purposes of point (b) of paragraph 1 where at least one of the following conditions is met: (a) the competent ministry or government and the resolution authority, after consulting the central bank and the competent authority, determine that the application of remaining resolution tools would not suffice to avoid a significant adverse effect on the financial system; (b) the competent ministry or government and the resolution authority determine that the application of remaining resolution tools would not suffice to protect the public interest, where extraordinary liquidity assistance from the central bank has previously been given to the CCP; (c) in respect of the temporary public ownership tool, the competent ministry or government, after consulting the competent authority and the resolution authority, determines that the application of remaining resolution tools would not suffice to protect the public interest, where public equity support through the equity support tool has previously been given to the CCP. Article 46 Public equity support tool 1. Public financial support may be provided for the recapitalisation of a CCP in exchange for instruments of ownership. 2. CCPs subject to the public equity support tool shall be managed on a commercial and professional basis. 3. The instruments of ownership referred to in paragraph 1 shall be sold to a private purchaser as soon as commercial and financial circumstances allow. Article 47 Temporary public ownership tool 1. A CCP may be taken into temporary public ownership by means of one or more transfer orders of instruments of ownership executed by a Member State to a transferee which is either of the following: (a) a nominee of the Member State; or (b) a company wholly owned by the Member State. 2. CCPs subject to the temporary public ownership tool shall be managed on a commercial and professional basis and, having regard to the possibility of recovering the cost of resolution, shall be sold to a private purchaser as soon as commercial and financial circumstances allow. In determining the timing of the sale of the CCP, the financial situation and relevant market conditions shall be taken into account. CHAPTER IV Resolution powers Article 48 General powers 1. The resolution authority shall have all the powers necessary to apply the resolution tools effectively, including all the following powers: (a) to require any person to provide the resolution authority with any information it requires to decide upon and prepare a resolution action, including updates and additional information to that provided in the resolution plan or required through on-site inspections; (b) to take control of a CCP under resolution and exercise all the rights and powers conferred upon holders of instruments of ownership and the CCP\u2019s board including the rights and powers under the operating rules of the CCP; (c) to transfer instruments of ownership issued by a CCP under resolution; (d) to transfer to another entity, with its consent, the CCP\u2019s rights, assets, obligations or liabilities; (e) to reduce, including to reduce to zero, the principal amount of or outstanding amount due in respect of debt instruments or other unsecured liabilities of a CCP under resolution; (f) to convert debt instruments or other unsecured liabilities of a CCP under resolution into instruments of ownership of that CCP or of a bridge CCP to which assets, rights, obligations or liabilities of the CCP under resolution have been transferred; (g) to cancel debt instruments issued by a CCP under resolution; (h) to reduce, including to reduce to zero, the nominal amount of instruments of ownership of a CCP under resolution and to cancel such instruments of ownership; (i) to require a CCP under resolution to issue new instruments of ownership, including preference shares and contingent convertible instruments; (j) with regards to debt instruments and other liabilities of the CCP, to amend or alter their maturity, amend the amount of interest payable, or amend the date on which interest becomes payable, including by suspending payment for a temporary period; (k) to close out and terminate financial contracts; (l) to remove or replace the board and senior management of a CCP under resolution; (m) to require the competent authority to assess the buyer of a qualifying holding in a timely manner by way of derogation from the time-limits laid down in Article 31 of Regulation (EU) No 648/2012; (n) to reduce, including to reduce to zero, the amount of variation margin due to a clearing member of a CCP under resolution; (o) to transfer open positions and any related assets, including relevant title transfer and security financial collateral arrangements, set-off arrangements, and netting arrangements, from the account of a defaulting clearing member to a non-defaulting clearing member in a manner consistent with Article 48 of Regulation (EU) No 648/2012; (p) to enforce any existing and outstanding contractual obligations of the clearing members of the CCP under resolution or, where necessary to achieve the resolution objectives, refrain from enforcing such contractual obligations or otherwise deviate from the CCP\u2019s operating rules; (q) to enforce any existing and outstanding obligations of the parent undertaking of the CCP under resolution including to provide the CCP with financial support by way of guarantees or credit lines; and (r) to require clearing members to provide further contributions in cash subject to the limit referred to in Article 31. Resolution authorities may exercise the powers referred to in the first subparagraph individually or in any combination. 2. Unless otherwise provided for in this Regulation and the Union State aid framework, the resolution authority shall not be subject to any of the following requirements where it exercises the powers referred to in paragraph 1: (a) requirement to obtain approval or consent from any public or private person; (b) requirements relating to the transfer of financial instruments, rights, obligations, assets or liabilities of a CCP under resolution or a bridge CCP; (c) requirement to notify any public or private person; (d) requirement to publish any notice or prospectus; (e) requirement to file or register any document with any other authority. Article 49 Ancillary powers 1. Where a power referred to in Article 48(1) of this Regulation is exercised, the resolution authority may also exercise any of the following ancillary powers: (a) subject to Article 67, to provide for a transfer to take effect free from any liability or encumbrance affecting the financial instruments, rights, obligations, assets or liabilities transferred; (b) to remove rights to acquire further instruments of ownership; (c) to require the relevant authority to discontinue or suspend the admission to trading on a regulated market, or the official listing, of any financial instruments issued by the CCP pursuant to Directive 2001/34/EC of the European Parliament and of the Council (25); (d) to provide for the purchaser or bridge CCP, pursuant to Articles 40 and 42 respectively, to be treated as if it were the CCP under resolution, for the purposes of any rights or obligations of, or actions taken by, the CCP under resolution, including any rights or obligations relating to participation in a market infrastructure; (e) to require the CCP under resolution or the purchaser or bridge CCP, where relevant, to provide the other with information and assistance; (f) to provide for the clearing member which is a recipient of any positions allocated to it by way of the powers in points (o) and (p) of Article 48(1) to assume any rights or obligations relating to participation in the CCP in relation to those positions; (g) to cancel or modify the terms of a contract to which the CCP under resolution is a party or substitute the purchaser or bridge CCP, in place of the CCP under resolution, as a party; (h) to modify or amend the operating rules of the CCP under resolution, including as regards its terms of access to clearing for its clearing members and other participants; (i) to transfer the membership of a clearing member from the CCP under resolution to a purchaser of the CCP or a bridge CCP. Any right of compensation provided for in this Regulation shall not be considered to be a liability or an encumbrance for the purposes of point (a) of the first subparagraph. 2. The resolution authority may provide for continuity arrangements necessary to ensure that the resolution action is effective and that the business transferred may be operated by the purchaser or bridge CCP. Those continuity arrangements may include: (a) the continuity of contracts entered into by the CCP under resolution, in order for the purchaser or bridge CCP to assume the rights and liabilities of the CCP under resolution relating to any financial instrument, right, obligation, asset or liability that has been transferred and to replace the CCP under resolution, expressly or implicitly, in all relevant contractual documents; (b) the replacement of the CCP under resolution by the purchaser or bridge CCP in any legal proceedings relating to any financial instrument, right, obligation, asset or liability that has been transferred. 3. The powers provided for in point (d) of paragraph 1, and point (b) of paragraph 2, of this Article shall not affect: (a) the right of an employee of the CCP to terminate a contract of employment; nor (b) subject to Articles 55, 56 and 57, the exercise of contractual rights of a party to a contract, including the right to terminate, where provided for in the terms of the contract, due to an act or omission by the CCP prior to the transfer, or by the purchaser or bridge CCP after the transfer. Article 50 Special management 1. The resolution authority may appoint one or more special managers to replace the board of a CCP under resolution. The special manager shall be of sufficiently good repute and shall have adequate expertise in financial services, risk management and clearing services in accordance with the second subparagraph of Article 27(2) of Regulation (EU) No 648/2012. 2. The special manager shall have all the powers of the shareholders and the board of the CCP. The special manager shall only exercise those powers under the control of the resolution authority. The resolution authority may limit the actions of the special manager or require prior consent for certain acts. The resolution authority shall make public the appointment referred to in paragraph 1 and the terms and conditions attached to that appointment. 3. The special manager shall be appointed for no more than one year. The resolution authority may renew that period where necessary to achieve the resolution objectives. 4. The special manager shall take all the measures necessary to promote the resolution objectives and implement resolution actions taken by the resolution authority. In the event of inconsistency or conflict, that statutory duty shall override any other duty of management in accordance with the statutes of the CCP or national law. 5. The special manager shall draw up reports for the appointing resolution authority at regular intervals set by the resolution authority and at the beginning and the end of the mandate. Those reports shall describe in detail the financial situation of the CCP and state the reasons for the measures taken. 6. The resolution authority may remove the special manager at any time. It shall in any case remove the special manager in the following cases: (a) where the special manager is failing to perform its duties in accordance with the terms and conditions set out by the resolution authority; (b) where the objectives of resolution would be better achieved by removing or replacing that special manager; or (c) where the conditions for the appointment are no longer fulfilled. Article 51 Power to require the provision of services and facilities 1. The resolution authority may require a CCP under resolution, any entity belonging to the same group as the CCP or any of the CCP\u2019s clearing members to provide any services or facilities that are necessary to enable a purchaser or bridge CCP to operate effectively the business transferred to it. The first subparagraph shall apply regardless of whether an entity in the same group as the CCP or one of the CCP\u2019s clearing members has entered into normal insolvency proceedings or is itself under resolution. 2. The resolution authority may enforce obligations imposed, pursuant to paragraph 1, by resolution authorities in other Member States where those powers are exercised in relation to entities belonging to the same group as the CCP under resolution, or in relation to the clearing members of that CCP. 3. The services and facilities referred to in paragraph 1 shall not include any form of financial support. 4. The services and facilities provided pursuant to paragraph 1 shall be provided: (a) on the same commercial terms on which they were provided to the CCP immediately before the resolution action was taken, where an agreement for the purposes of providing those services and facilities exists; or (b) on reasonable commercial terms, where there is no agreement for the purposes of providing those services and facilities or where that agreement has expired. Article 52 Power to enforce crisis prevention measures or resolution actions by other Member States 1. Where instruments of ownership, assets, rights, obligations or liabilities of a CCP under resolution are located in, or governed by the law of a Member State other than the Member State of the resolution authority, any transfer or resolution action in respect of those instruments, assets, rights, obligations or liabilities shall have effect in accordance with the law of that other Member State. 2. The resolution authority of a Member State shall be provided with all necessary assistance by the authorities of other relevant Member States to ensure that any instruments of ownership, assets, rights, obligations or liabilities are transferred to the purchaser or bridge CCP or any other resolution action becomes effective in accordance with the applicable national law. 3. Shareholders, creditors and third parties that are affected by the transfer of instruments of ownership, assets, rights, obligations or liabilities referred to in paragraph 1 shall not be entitled to prevent, challenge, or set aside that transfer under the law of the Member State where the assets are located or that governs the transfer of the instruments of ownership, assets, rights, obligations or liabilities. 4. Where the resolution authority of a Member State applies the resolution tools referred to in Articles 28 to 32, and the contracts, liabilities, instruments of ownership or debt instruments of the CCP under resolution include instruments, contracts or liabilities that are governed by the law of another Member State, or liabilities owed to creditors and contracts in respect of clearing members and, where applicable, their clients located in that other Member State, the relevant authorities in that other Member State shall ensure that any action resulting from those resolution tools takes effect. For the purposes of the first subparagraph, shareholders, creditors and clearing members and, where applicable, their clients affected by those resolution tools shall be entitled to challenge the reduction of the principal or payable amount of the instrument or liability or its conversion or restructuring, as the case may be, only under the law of the Member State of the resolution authority. 5. The following rights and safeguards shall be determined in accordance with the law of the Member State of the resolution authority: (a) the right for shareholders, creditors and third parties to appeal pursuant to Article 74 against the transfer of instruments of ownership, assets, rights, obligations or liabilities referred to in paragraph 1 of this Article; (b) the right for affected creditors to appeal pursuant to Article 74 against the reduction of the principal or payable amount or the conversion or restructuring of an instrument, liability or contract covered by paragraph 4 of this Article; and (c) the safeguards for partial transfers, as referred to in Chapter V, in relation to assets, rights, obligations or liabilities referred to in paragraph 1. Article 53 Power in respect of assets, contracts, rights, liabilities, obligations and instruments of ownership of persons located in or governed by the law of third countries 1. Where a resolution action concerns assets or contracts of persons located in a third country or instruments of ownership, rights, obligations or liabilities governed by the law of a third country, the resolution authority may require that: (a) the CCP under resolution and the recipient of those assets, contracts, instruments of ownership, rights, obligations or liabilities take all necessary steps to ensure that the action becomes effective; (b) the CCP under resolution holds the instruments of ownership, assets or rights or discharges the liabilities or obligations on behalf of the recipient until the action becomes effective; (c) the reasonable expenses of the recipient properly incurred in carrying out any action required under points (a) and (b) of this paragraph are reimbursed in any of the ways referred to in Article 27(10). 2. For the purposes of paragraph 1 of this Article, the resolution authority shall require the CCP to ensure the inclusion of a provision in its contracts and other agreements with clearing members and holders of instruments of ownership and debt instruments located in or governed by the law of third countries by which they agree to be bound by any action in respect of their assets, contracts, rights, obligations and liabilities taken by the resolution authority, including the application of Articles 28, 32, 55, 56 and 57. The resolution authority may require the CCP to ensure the inclusion of such a provision in its contracts and other agreements with holders of other liabilities located in or governed by the law of third countries. The resolution authority may require the CCP to provide it with a reasoned legal opinion by an independent legal expert confirming the legal enforceability and effectiveness of such provisions. 3. Where the resolution action referred to in paragraph 1 does not become effective, that action shall be void in relation to the instruments of ownership, assets, rights, obligations or liabilities concerned. Article 54 Exclusion of certain contractual terms in early intervention and resolution 1. A crisis prevention measure or a resolution action taken in accordance with this Regulation, or any event directly linked to the application of that action, shall not be deemed to be insolvency proceedings, an enforcement event or an event of default within the meaning of Directive 98/26/EC, Directive 2002/47/EC and Regulation (EU) No 575/2013 respectively provided that the substantive obligations under the contract, including payment and delivery obligations, and the provision of collateral, continue to be performed. For the purposes of the first subparagraph of this paragraph, third-country resolution proceedings recognised pursuant to Article 77, or otherwise where the resolution authority so decides, shall be considered a resolution action taken in accordance with this Regulation. 2. A crisis prevention measure or a resolution action referred to in paragraph 1 shall not be used to: (a) exercise any termination, suspension, modification, netting or set-off rights, including in relation to a contract entered into by any entity of the group to which the CCP belongs which includes cross-default provisions or obligations which are guaranteed or otherwise supported by any group entity; (b) obtain possession, exercise control or enforce any security over any property of the CCP concerned or any group entity in relation to a contract which includes cross-default provisions; or (c) affect any contractual rights of the CCP concerned or any group entity in relation to a contract which includes cross-default provisions. Article 55 Power to suspend certain obligations 1. The resolution authority may suspend any payment or delivery obligations of both counterparties to any contract entered into by a CCP under resolution from the publication of the notice of suspension in accordance with Article 72 until the end of the working day which follows that publication. For the purposes of the first subparagraph, the end of the working day shall mean midnight in the Member State of the resolution authority. 2. Where a payment or delivery obligation would have been due during the suspension period, the payment or delivery obligation shall be due immediately upon expiry of the suspension period. 3. The resolution authority shall not exercise the power referred to in paragraph 1 to payment and delivery obligations owed to systems or operators of systems designated for the purposes of Directive 98/26/EC, other CCPs, and central banks. Article 56 Power to restrict the enforcement of security interests 1. The resolution authority may prevent secured creditors of a CCP under resolution from enforcing security interests in relation to any assets of that CCP under resolution from the publication of the notice of the restriction in accordance with Article 72 until the end of the working day which follows that publication. For the purposes of the first subparagraph, the end of the working day shall mean midnight in the Member State of the resolution authority. 2. The resolution authority shall not exercise the power referred to in paragraph 1 in relation to any security interest of systems or operators of systems designated for the purposes of Directive 98/26/EC, other CCPs, and central banks over assets pledged or provided by way of margin or collateral by the CCP under resolution. Article 57 Power to temporarily suspend termination rights 1. The resolution authority may suspend the termination rights of any party to a contract with a CCP under resolution from the publication of the notice of the termination in accordance with Article 72 until the end of the working day which follows that publication, provided that the payment and delivery obligations and the provision of collateral continue to be performed. For the purposes of the first subparagraph, the end of the working day shall mean midnight in the Member State of the resolution. 2. The resolution authority shall not exercise the power referred to in paragraph 1 in relation to systems or operators of systems designated for the purposes of Directive 98/26/EC, other CCPs and central banks. 3. A party to a contract may exercise a termination right under that contract before the end of the period referred to in paragraph 1 where that party receives notice from the resolution authority that the rights and liabilities covered by the contract shall not be: (a) transferred to another entity; or (b) subject to write-down, conversion, or the application of a resolution tool to allocate losses or positions. 4. Where the notice referred to in paragraph 3 of this Article has not been given, termination rights may be exercised on the expiry of the period of suspension, subject to Article 54, as follows: (a) where the rights and liabilities covered by the contract have been transferred to another entity, a counterparty may exercise termination rights in accordance with the terms of that contract only if the recipient entity causes the enforcement event to occur or continue; (b) where the rights and liabilities covered by the contract remain with the CCP, a counterparty may exercise termination rights in accordance with the conditions for termination as set out in the contract between the CCP and the relevant counterparty only if the enforcement event occurs or continues after the expiry of a suspension under paragraph 1 of this Article. Article 58 Power to exercise control over the CCP 1. The resolution authority may exercise control over the CCP under resolution to: (a) manage the activities and services of the CCP, exercising the powers of its shareholders and board; (b) consult the risk committee; (c) manage and dispose of the assets and property of the CCP under resolution. The control referred to in the first subparagraph of this paragraph may be exercised directly by the resolution authority or indirectly by a special manager appointed by the resolution authority in accordance with Article 50(1). 2. Where the resolution authority exercises control over the CCP, the resolution authority shall not be deemed to be a shadow director or de facto director under national law. Article 59 Exercise of powers by the resolution authorities Without prejudice to Article 74, resolution authorities shall take resolution actions through executive orders in accordance with national administrative competences and procedures. CHAPTER V Safeguards Article 60 \u2018No creditor worse off\u2019 principle Where the resolution authority applies one or more resolution tools, it shall ensure that shareholders, clearing members and other creditors do not incur greater losses than they would have incurred had the resolution authority not taken resolution action in relation to the CCP at the time the resolution authority considered that the conditions for resolution pursuant to Article 22(1) were met and had the CCP instead been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations and other arrangements in its operating rules. Article 61 Valuation for the application of the \u2018no creditor worse off\u2019 principle 1. For the purposes of assessing compliance with the \u2018no creditor worse off\u2019 principle as laid down in Article 60, the resolution authority shall ensure that a valuation is carried out by an independent person as soon as possible after the resolution action or actions have been effected. 2. The valuation referred to in paragraph 1 shall include: (a) the treatment that shareholders, clearing members and other creditors would have received had the resolution authority not taken resolution action in relation to the CCP at the time the resolution authority considered that the conditions for resolution pursuant to Article 22(1) were met and had the CCP instead been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations and other arrangements in its operating rules; (b) the actual treatment that shareholders, clearing members and other creditors, have received in the resolution of the CCP; (c) whether there is any difference between the treatment referred to in point (a) of this paragraph and the treatment referred to in point (b) of this paragraph. 3. For the purposes of calculating the treatments referred to in point (a) of paragraph 2, the valuation referred to in paragraph 1 shall: (a) disregard any provision of extraordinary public financial support to the CCP under resolution or central bank emergency liquidity assistance or any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest terms; (b) be based on the losses that would have been realistically incurred by clearing members and other creditors, had the CCP been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations and other arrangements in its operating rules; (c) take into account a commercially reasonable estimate of the direct replacement costs, including any additional margin requirements, incurred by the clearing members to reopen within an appropriate period their comparable net positions in the market by considering effective market conditions, including market depth and ability of the market to transact the relevant volume of such net positions within that period; and (d) be based on the CCP\u2019s own pricing methodology unless such methodology for price determination does not reflect the effective market conditions. The length of the period referred to in point (c) of the first subparagraph shall reflect the implications of the applicable insolvency law and the characteristics of the relevant net positions. 4. The valuation referred to in paragraph 1 of this Article shall be distinct from the valuation carried out under Article 24(3). 5. ESMA, taking into account the regulatory technical standards adopted pursuant to Articles 49(5) and 74(4) of Directive 2014/59/EU, shall develop draft regulatory technical standards specifying the methodology for carrying out the valuation referred to in paragraph 1 of this Article including the calculation of the losses following liquidation resulting from the costs referred to in point (c) of the first subparagraph of paragraph 3 of this Article had the CCP been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations and other arrangements in its operating rules. ESMA shall submit those draft regulatory standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 62 Safeguard for shareholders, clearing members and other creditors Where, in accordance with the valuation carried out under Article 61, any shareholder, clearing member or other creditor has incurred greater losses than it would have incurred had the resolution authority not taken resolution action in relation to the CCP and had the CCP instead been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations or other arrangements in its operating rules, that shareholder, clearing member or other creditor shall be entitled to the payment of the difference. Article 63 Safeguard for clients and indirect clients 1. Contractual arrangements allowing clearing members to pass on to their clients the negative consequences of the resolution tools shall also include, on an equivalent and proportionate basis, the right of clients to any recompense or compensation clearing members receive in accordance with Article 27(6) or any cash equivalent of such recompense or compensation or any proceeds they receive following a claim made in accordance with Article 62 to the extent that such proceeds are related to client positions. Those provisions shall also apply to the contractual arrangements by clients and indirect clients offering indirect clearing services to their clients. 2. ESMA shall develop draft regulatory technical standards in order to specify, in a transparent manner, to the extent allowed by confidentiality of contractual arrangements, the conditions under which the passing on of compensation, cash equivalent of such compensation or any proceeds referred to in the paragraph 1 is required, and the conditions under which it is to be considered proportionate. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 64 Recoupment of payments The resolution authority shall recover, to the largest extent possible, any reasonable expenses incurred in connection with a payment as referred to in Article 62 in any of the following ways: (a) from the CCP under resolution, as a preferred creditor; (b) from any consideration paid by the purchaser where the sale of business tool has been applied; (c) from any proceeds generated as a result of the termination of the bridge CCP, as a preferred creditor. Article 65 Safeguard for counterparties in partial transfers The protections provided for in Articles 66, 67 and 68 shall apply in the following circumstances: (a) where the resolution authority transfers some but not all of the assets, rights, obligations or liabilities of a CCP under resolution to another entity or, in the application of a resolution tool, from a bridge CCP to a purchaser; and (b) where the resolution authority exercises the powers referred to in point (g) of Article 49(1). Article 66 Protection for financial collateral, set off and netting arrangements The resolution authority shall ensure that the application of a resolution tool, other than the position allocation tool referred to in Article 29, does not result in transferring some but not all of the rights and liabilities under a title transfer financial collateral arrangement, a set-off arrangement or a netting arrangement between a CCP under resolution and other parties to the arrangements, or in modifying or terminating the rights and liabilities under those arrangements through the use of ancillary powers. The arrangements referred to in the first subparagraph shall include any arrangement to which the parties are entitled to set-off or net those rights and liabilities. Article 67 Protection for security arrangements The resolution authority shall ensure that the application of a resolution tool does not result in any of the following with respect to security arrangements between a CCP under resolution and other parties to those arrangements: (a) the transfer of assets against which the liability is secured unless that liability and benefit of the security are also transferred; (b) the transfer of a secured liability unless the benefit of the security is also transferred; (c) the transfer of the benefit of the security unless the secured liability is also transferred; (d) the modification or termination of a security arrangement through the use of ancillary powers, if the effect of that modification or termination is that the liability ceases to be secured. Article 68 Protection for structured finance arrangements and covered bonds The resolution authority shall ensure that the application of a resolution tool does not result in any of the following with respect to structured finance arrangements, including covered bonds: (a) the transfer of some, but not all, of the assets, rights and liabilities which constitute or form part of a structured finance arrangement to which the CCP under resolution is a party; (b) the termination or modification through the use of ancillary powers of the assets, rights and liabilities which constitute or form part of a structured finance arrangement to which the CCP under resolution is a party. For the purposes of the first subparagraph, structured finance arrangements shall include securitisations and instruments used for hedging purposes which form an integral part of the cover pool and which according to national law are secured in a way similar to the covered bonds, which involve the granting and holding of security by a party to the arrangement or a trustee, agent or nominee. Article 69 Partial transfers: protection of trading, clearing and settlement systems 1. The resolution authority shall ensure that the application of a resolution tool does not affect the operation of systems and rules of systems covered by Directive 98/26/EC, where the resolution authority: (a) transfers some but not all of the assets, rights, obligations or liabilities of a CCP under resolution to another entity; (b) cancels or amends the terms of a contract to which the CCP under resolution is a party or substitutes a purchaser or bridge CCP as a party. 2. For the purposes of paragraph 1 of this Article, the resolution authority shall ensure that the application of a resolution tools does not result in any of the following outcomes: (a) revoking a transfer order in accordance with Article 5 of Directive 98/26/EC; (b) affecting the enforceability of transfer orders and netting as required by Articles 3 and 5 of Directive 98/26/EC; (c) affecting the use of funds, securities or credit facilities as required by Article 4 of Directive 98/26/EC; (d) affecting the protection of collateral security as required by Article 9 of Directive 98/26/EC. CHAPTER VI Procedural obligations Article 70 Notification requirements 1. The CCP shall notify the competent authority where it considers that it is failing or likely to fail as referred to in Article 22(2). 2. The competent authority shall inform the resolution authority of any notifications received under paragraph 1, and of any recovery or other measures in accordance with Title IV that the competent authority requires the CCP to take. The competent authority shall inform the resolution authority of any emergency situation referred to in Article 24 of Regulation (EU) No 648/2012 relating to a CCP and of any notification received in accordance with Article 48 of that Regulation. 3. Where a competent authority or resolution authority determines that the conditions referred to in points (a) and (b) of Article 22(1) or in Article 22(3) are met in relation to a CCP, it shall notify without undue delay the following bodies: (a) the competent authority or resolution authority for that CCP; (b) the competent authority for the parent undertaking of the CCP; (c) the central bank; (d) the competent ministry; (e) the ESRB and the designated national macro-prudential authority; and (f) the supervisory college and resolution college for that CCP. Article 71 Decision of the resolution authority 1. After a notification from the competent authority pursuant to Article 70(3), the resolution authority shall determine whether any resolution action is needed. 2. The decision whether or not to take resolution action in relation to a CCP shall contain information on the following: (a) the resolution authority\u2019s assessment of whether the CCP meets the conditions for resolution; and (b) any action that the resolution authority intends to take, including the decision to apply for winding up, the appointment of an administrator or any other measure under applicable normal insolvency proceedings. Article 72 Procedural obligations of resolution authorities 1. The resolution authority shall notify the resolution college of the resolution actions it intends to take. That notification shall also indicate whether the resolution actions deviate from the resolution plan. As soon as practicable after taking a resolution action, the resolution authority shall notify all of the following: (a) the CCP under resolution; (b) the resolution college; (c) the designated national macroprudential authority and the ESRB; (d) the Commission, ECB, and EIOPA; and (e) the operators of the systems covered by Directive 98/26/EC in which the CCP under resolution participates. 2. The notification referred to in the second subparagraph of paragraph 1 shall include a copy of any order or instrument by which the relevant action is taken and indicate the date from which the resolution action is effective. The notification to the resolution college pursuant to second subparagraph of paragraph 1 shall provide the reasons for any deviation from the resolution plan. 3. A copy of the order or instrument by which the resolution action is taken, or a notice summarising the effects of the resolution action and, if applicable, the terms and period of suspension or restriction referred to in Articles 55, 56 and 57 of this Regulation, shall be published on all of the following: (a) the website of the resolution authority; (b) the website of the competent authority, if different from the resolution authority, and the website of ESMA; (c) the website of the CCP under resolution; and (d) where the instruments of ownership or debt instruments of the CCP under resolution are admitted to trading on a regulated market, the means used for the disclosure of regulated information concerning the CCP under resolution in accordance with Article 21(1) of Directive 2004/109/EC of the European Parliament and of the Council (26). 4. Where the instruments of ownership or debt instruments are not admitted to trading on a regulated market, the resolution authority shall ensure that the documents providing proof of the order referred to in paragraph 3 are sent to the holders of the instruments of ownership and creditors of the CCP under resolution that are known through the registers or databases of the CCP under resolution which are available to the resolution authority. Article 73 Confidentiality 1. The requirements of professional secrecy shall be binding in respect of the following persons: (a) resolution authorities; (b) competent authorities, ESMA and EBA; (c) competent ministries; (d) special managers or temporary administrators appointed under this Regulation; (e) potential acquirers that are contacted by the competent authorities or solicited by the resolution authorities, irrespective of whether that contact or solicitation was made as preparation for the application of the sale of business tool, and irrespective of whether the solicitation resulted in an acquisition; (f) auditors, accountants, legal and professional advisors, valuers and other experts directly or indirectly engaged by the resolution authorities, competent authorities, competent ministries or by the potential acquirers referred to in point (e); (g) central banks and other authorities involved in the resolution process; (h) a bridge CCP; (i) the senior management and members of the board of the CCP, and employees of the bodies or entities referred to in points (a) to (k) before, during and after their appointment; (j) all other members of the resolution college not referred to in points (a), (b), (c) and (g); and (k) any other persons who provide or have provided services directly or indirectly, permanently or occasionally, to persons referred to in points (a) to (j). 2. With a view to ensuring that the confidentiality requirements laid down in paragraphs 1 and 3 are complied with, the persons referred to in points (a), (b), (c), (g), (h) and (j) of paragraph 1 shall ensure that there are internal rules in place, including rules to secure secrecy of information between persons directly involved in the resolution process. 3. The persons referred to in paragraph 1 shall be prohibited from disclosing confidential information received during the course of their professional activities or from a competent authority or resolution authority in connection with their functions under this Regulation, to any person or authority unless it is in the exercise of their functions under this Regulation, or in summary or aggregate form such that individual CCPs cannot be identified, or with the express and prior consent of the authority or the CCP which provided the information. Before disclosing any type of information, the persons referred to in paragraph 1 shall assess the effects that the disclosure may have on the public interest as regards financial, monetary or economic policy, on the commercial interests of natural and legal persons, on the purpose of inspections, on investigations and on audits. The procedure for checking the effects of disclosing information shall include a specific assessment of the effects of any disclosure of the contents and details of recovery and resolution plans as referred to in Articles 9 and 12 and the result of any assessment carried out under Articles 10 and 15. Any person or entity referred to in paragraph 1 shall be subject to civil liability in the event of an infringement of this Article, in accordance with national law. 4. By way of derogation from paragraph 3, the persons referred to in paragraph 1 may exchange confidential information with any of the following provided that the recipient is subject to requirements of confidentiality for the purposes of that exchange: (a) any other person where necessary for the purposes of planning or carrying out a resolution action; (b) parliamentary enquiry committees in their Member State, courts of auditors in their Member State and other entities in charge of enquiries in their Member State; (c) national authorities responsible for overseeing payment systems, authorities responsible for normal insolvency proceedings, authorities entrusted with the public duty of supervising other financial sector entities, authorities responsible for the supervision of financial markets and insurance undertakings and inspectors acting on their behalf, authorities responsible for maintaining the stability of the financial system in Member States through the use of macroprudential rules, authorities responsible for protecting the stability of the financial system, and persons responsible for carrying out statutory audits. 5. This Article shall not prevent: (a) employees and experts of the bodies or entities referred to in points (a) to (g), and in point (j), of paragraph 1 from sharing information among themselves within each body or entity; (b) resolution authorities and competent authorities, including their employees and experts, from sharing information with each other and with other Union resolution authorities, other Union competent authorities, competent ministries, central banks, authorities responsible for normal insolvency proceedings, authorities responsible for maintaining the stability of the financial system in Member States through the use of macroprudential rules, persons charged with carrying out statutory audits of accounts, EBA, ESMA, or, subject to Article 80, third-country authorities that carry out equivalent functions to resolution authorities, or, subject to strict confidentiality requirements, to a potential acquirer for the purposes of planning or carrying out a resolution action. 6. This Article shall be without prejudice to national law concerning the disclosure of information for the purpose of legal proceedings in criminal or civil cases. CHAPTER VII Right of appeal and exclusion of other actions Article 74 Ex-ante judicial approval and rights of appeal 1. A decision to take a crisis prevention measure or resolution action may be subject to ex-ante judicial approval where provided in national law, where the procedure relating to that approval and the court\u2019s consideration are expeditious. 2. All persons affected by a decision to take a crisis prevention measure or a decision to exercise any power, other than a resolution action, shall have the right of appeal against that decision. 3. All persons affected by a decision to take a resolution action shall have the right of appeal against that decision. 4. The right of appeal referred to in paragraph 3 shall be subject to the following conditions: (a) the lodging of an appeal shall not entail any automatic suspension of the effects of the challenged decision; (b) the decision of the resolution authority shall be immediately enforceable and it shall give rise to a rebuttable presumption that a suspension of its enforcement would be against the public interest; and (c) the procedure relating to the appeal shall be expeditious. 5. The court shall use the economic assessments of the facts carried out by the resolution authority as a basis for its own assessment. 6. Where necessary to protect the interests of third parties acting in good faith who have acquired instruments of ownership, assets, rights, obligations or liabilities of a CCP under resolution by virtue of a resolution action, the annulment of a decision of a resolution authority shall not affect any subsequent administrative acts or transactions concluded by the resolution authority concerned which were based on the annulled decision. For the purposes of the first subparagraph, the remedies available to the applicant where a decision of the resolution authority is annulled shall be limited to compensation for the loss suffered as a result of that decision. Article 75 Restrictions on other proceedings 1. Normal insolvency proceedings shall not be commenced in relation to a CCP except at the initiative of the resolution authority or with its consent in accordance with paragraph 3. 2. Competent authorities and resolution authorities shall be notified without delay of any application for the opening of normal insolvency proceedings in relation to a CCP, irrespective of whether the CCP is under resolution or a decision has been made public in accordance with Article 72(3). 3. The authorities responsible for normal insolvency proceedings shall only commence those proceedings after the resolution authority has notified them of its decision not to take any resolution action in relation to the CCP or where no notification has been received within seven days of the notification referred to in paragraph 2. Where necessary for the effective application of the resolution tools and powers, resolution authorities may request the court to apply a stay on any judicial action or proceeding in which a CCP under resolution is or may become a party for an appropriate period in accordance with the resolution objectives. TITLE VI RELATIONS WITH THIRD COUNTRIES Article 76 Agreements with third countries 1. In accordance with Article 218 TFEU, the Commission may submit to the Council recommendations for the negotiation of agreements with one or more third countries regarding the means of cooperation between the resolution authorities and the relevant third-country authorities in connection with recovery and resolution planning in relation to CCPs and third-country CCPs, with regard to the following situations: (a) where a third-country CCP provides services or has subsidiaries in one or more Member States; (b) where a CCP established in a Member State provides services or has one or more subsidiaries in a third country. 2. The agreements referred to in paragraph 1 of this Article shall, in particular, seek to ensure the establishment of processes and arrangements for cooperation in carrying out the tasks and exercising the powers referred to in Article 79, including the exchange of information necessary for those purposes. Article 77 Recognition and enforcement of third-country resolution proceedings 1. This Article shall apply in respect of third-country resolution proceedings unless and until an international agreement as referred to in Article 76(1) enters into force with the relevant third country. It shall also apply following the entry into force of an international agreement as referred to in Article 76(1) with the relevant third country to the extent that recognition and enforcement of third-country resolution proceedings is not governed by that agreement. 2. Relevant national authorities shall recognise third-country resolution proceedings relating to a third-country CCP in any of the following cases: (a) the third-country CCP provides services, or has subsidiaries established, in one or more Member States; (b) the third-country CCP has assets, rights, obligations or liabilities located in one or more Member States or are governed by the law of those Member States. Relevant national authorities shall ensure the enforcement of the recognised third-country resolution proceedings in accordance with their national law. 3. The relevant national authorities shall at least have the power to do the following: (a) exercise the resolution powers in relation to the following: (i) assets of a third-country CCP that are located in their Member State or governed by the law of their Member State; and (ii) rights or liabilities of a third-country CCP that are booked in their Member State or governed by the law of their Member State, or where claims in relation to such rights and liabilities are enforceable in their Member State; (b) perfect, including to require another person to take action to perfect, a transfer of instruments of ownership in a subsidiary established in the designating Member State; (c) exercise the powers in Article 55, 56 and 57 in relation to the rights of any party to a contract with an entity referred to in paragraph 2 of this Article, where such powers are necessary in order to enforce third-country resolution proceedings; and (d) render unenforceable any right to terminate, liquidate or accelerate contracts, or affect the contractual rights, of entities referred to in paragraph 2 and other group entities, where such a right arises from resolution action taken in respect of the third-country CCP, whether by the third-country resolution authority itself or otherwise pursuant to legal or regulatory requirements as to resolution arrangements in that country, provided that the substantive obligations under the contract, including payment and delivery obligations, and provision of collateral, continue to be performed. 4. The recognition and enforcement of third-country resolution proceedings shall be without prejudice to any normal insolvency proceedings applicable under national law. Article 78 Right to refuse recognition or enforcement of third-country resolution proceedings By way of derogation from Article 77(2), the relevant national authorities may refuse to recognise or to enforce third-country resolution proceedings in any of the following cases: (a) the third-country resolution proceedings would have adverse effects on financial stability in their Member State; (b) creditors, clearing members and, where applicable, their clients located in their Member State would not receive the same treatment as third-country creditors, clearing members and, where applicable, their clients with similar legal rights under the third-country home resolution proceedings; (c) recognition or enforcement of the third-country resolution proceedings would have material fiscal implications for their Member State; (d) the recognition or enforcement would be contrary to national law. Article 79 Cooperation with third-country authorities 1. This Article shall apply in respect of cooperation with a third country unless and until an international agreement as referred to in Article 76(1) enters into force with the relevant third country. It shall also apply following the entry into force of an international agreement provided for in Article 76(1) with the relevant third country to the extent that the subject matter of this Article is not governed by that agreement. 2. Competent authorities or resolution authorities, where appropriate, shall conclude cooperation arrangements with the following relevant third-country authorities, taking into account existing cooperation arrangements established pursuant to Article 25(7) of Regulation (EU) No 648/2012: (a) where a third-country CCP provides services or has subsidiaries in one or more Member States, the relevant third-country authorities where the CCP is established; (b) where a CCP provides services in or has one or more third-country subsidiaries, the relevant third-country authorities where those services are provided or where the subsidiaries are established. 3. The cooperation arrangements referred to in paragraph 2 of this Article shall establish processes and arrangements between the participating authorities for sharing the necessary information for, and cooperating in, carrying out the following tasks and exercising the following powers in relation to CCPs referred to in points (a) and (b) of that paragraph or groups including such CCPs: (a) the drawing up of resolution plans in accordance with Article 12 and similar requirements under the law of the relevant third countries; (b) the assessment of the resolvability of such institutions and groups, in accordance with Article 15 and similar requirements under the law of the relevant third countries; (c) the application of powers to address or remove impediments to resolvability pursuant to Article 16 and any similar powers under the law of the relevant third countries; (d) the application of early intervention measures pursuant to Article 18 and similar powers under the law of the relevant third countries; and (e) the application of resolution tools and exercise of resolution powers and similar powers conferred upon the relevant third-country authorities. 4. Cooperation arrangements concluded between resolution authorities and competent authorities of Member States and third countries pursuant to paragraph 2 may include provisions on the following matters: (a) the exchange of information necessary for the preparation and maintenance of resolution plans; (b) consultation and cooperation in drawing up resolution plans, including principles for the exercise of powers under Article 77 and similar powers under the law of the relevant third countries; (c) the exchange of information necessary for the application of resolution tools and exercise of resolution powers and similar powers under the law of the relevant third countries; (d) early warning to or consultation of parties to the cooperation arrangement before taking any significant action under this Regulation or relevant third-country law affecting the CCP or group to which the arrangement relates; (e) the coordination of public communication in the case of joint resolution actions; (f) procedures and arrangements for the exchange of information and cooperation under points (a) to (e) of this paragraph, including, where appropriate, through the establishment and operation of crisis management groups. In order to ensure the common, uniform and consistent application of paragraph 3, ESMA shall issue guidelines on the types and content of the provisions referred to in this paragraph by 12 August 2022. 5. Resolution authorities and competent authorities shall notify ESMA of any cooperation agreements that they have concluded in accordance with this Article. Article 80 Exchange of confidential information 1. Resolution authorities, competent authorities, competent ministries and, where applicable, other relevant national authorities shall exchange confidential information, including recovery plans, with relevant third-country authorities only if the following conditions are met: (a) those third-country authorities are subject to requirements and standards of professional secrecy at least considered to be equivalent, in the opinion of all the authorities concerned, to those imposed by Article 73; and (b) the information is necessary for the performance by the relevant third-country authorities of their functions under national law that are comparable to those under this Regulation and is not used for any other purposes. 2. In so far as the exchange of information relates to personal data, the handling and transmission of such personal data to third-country authorities shall be governed by the applicable Union and national data protection law. 3. Where confidential information originates in another Member State, resolution authorities, competent authorities and competent ministries shall not disclose that information to relevant third-country authorities unless the following conditions are met: (a) the relevant authority of the Member State where the information originated agrees to that disclosure; and (b) the information is disclosed only for the purposes permitted by the authority referred to in point (a). 4. For the purposes of this Article, information is deemed to be confidential if it is subject to confidentiality requirements under Union law. TITLE VII ADMINISTRATIVE MEASURES AND PENALTIES Article 81 Administrative penalties and other administrative measures 1. Without prejudice to the right of Member States to provide for and impose criminal penalties, Member States shall lay down rules on administrative penalties and other administrative measures applicable where this Regulation has not been complied with, and shall take all measures necessary to ensure that they are implemented. Where Member States decide not to lay down rules on administrative penalties for infringements which are subject to national criminal law, they shall communicate to the Commission and to ESMA the relevant criminal law provisions. The administrative penalties and other administrative measures shall be effective, proportionate and dissuasive. By 12 August 2022, Member States shall notify, in detail, the rules referred to in the first and second subparagraphs of this paragraph to the Commission and to ESMA. They shall notify the Commission and ESMA without delay of any subsequent amendments thereto. 2. Member States shall ensure that, where the obligations referred to in paragraph 1 apply to CCPs and clearing members, in the event of an infringement, the administrative penalties or other administrative measures referred to in that paragraph can be applied, subject to the conditions laid down in national law, to the board and the senior management of CCPs and of clearing members and to other natural persons who under national law are responsible for the infringement. 3. The powers to impose administrative penalties or other administrative measures provided for in this Regulation shall be attributed to resolution authorities or, where different, to competent authorities, depending on the type of infringement. Resolution authorities and competent authorities shall have all information-gathering and investigatory powers that are necessary for the exercise of their respective functions. In the exercise of their powers to impose penalties, resolution authorities and competent authorities shall cooperate closely to ensure that administrative penalties or other administrative measures produce the desired results and coordinate their action when dealing with cross-border cases. 4. Resolution authorities and competent authorities shall exercise their powers to impose administrative penalties or other administrative measures in accordance with this Regulation and national law in any of the following ways: (a) directly; (b) in collaboration with other authorities; (c) under their responsibility by delegation to such authorities; (d) by application to the competent judicial authorities. Article 82 Specific provisions 1. Member States shall ensure that their laws, regulations and administrative provisions provide for penalties and other administrative measures at least in respect of the following situations: (a) failure to draw up, maintain and update recovery plans, in breach of Article 9; (b) failure to provide all the information necessary for the development of resolution plans, in breach of Article 13; and (c) failure of the CCP to notify the competent authority when the CCP is failing or likely to fail, in breach of Article 70(1). 2. Member States shall ensure that, in the cases referred to in paragraph 1, the administrative penalties and other administrative measures that can be applied include at least the following: (a) a public statement which indicates the natural person, CCP, or other legal person responsible and the nature of the infringement; (b) an order requiring the natural or legal person responsible to cease the conduct and to desist from a repetition of that conduct; (c) a temporary ban against the members of the senior management of the CCP or any other natural person, who is held responsible, to exercise functions in a CCP; (d) in the case of a legal person, administrative fines of up to 10 % of the total annual turnover of that legal person in the preceding business year. Where the legal person is a subsidiary of a parent undertaking, the relevant turnover shall be the turnover resulting from the consolidated accounts of the ultimate parent undertaking in the preceding business year; (e) in the case of a natural person, administrative fines of up to EUR 5 000 000, or in the Member States where the euro is not the official currency, the corresponding value in the national currency on 11 February 2021; and (f) administrative fines of up to twice the amount of the benefit derived from the infringement where that benefit can be determined. Article 83 Publication of administrative penalties or other administrative measures 1. Resolution authorities or competent authorities shall publish on their official website any administrative penalties or administrative measures imposed by them for infringements of this Regulation where such penalties or measures have not been the subject of an appeal or where the right of appeal has been exhausted. Such publication shall take place without undue delay after the natural or legal person is informed of that penalty or measure and shall include information on the type and nature of the infringement and the identity of the natural or legal person on whom the penalty or measure is imposed. Where Member States permit publication of administrative penalties or other administrative measures against which there is an appeal, resolution authorities and competent authorities shall, without undue delay, publish on their official websites information on the status of that appeal and the outcome thereof. 2. Resolution authorities and competent authorities shall publish the administrative penalties or other administrative measures imposed by them on an anonymous basis, in a manner which is in accordance with national law, in any of the following circumstances: (a) where the administrative penalty or other administrative measure is imposed on a natural person and publication of personal data is shown to be disproportionate by an obligatory prior assessment of the proportionality of such publication; (b) where publication would jeopardise the stability of financial markets or an ongoing criminal investigation or proceedings; (c) where publication would cause, insofar as it can be determined, disproportionate damage to the CCP or natural persons involved. Alternatively, in such cases, the publication of the data in question may be postponed for a reasonable period, if it is foreseeable that the reasons for anonymous publication will cease to exist within that period. 3. Resolution authorities and competent authorities shall ensure that any publication in accordance with this Article shall remain on their official website for a period of at least five years. Personal data contained in the publication shall only be kept on the official website of the resolution authority or the competent authority for the period which is necessary in accordance with applicable data protection rules. 4. By 12 August 2022, ESMA shall submit a report to the Commission on the publication of administrative penalties and other administrative measures by Member States on an anonymous basis as provided for under paragraph 2 and in particular whether there have been significant divergences between Member States in that respect. That report shall also address any significant divergences in the duration of publication of administrative penalties or other administrative measures under national law of Member States for publication of administrative penalties and other administrative measures. Article 84 Maintenance of central database by ESMA 1. Subject to the professional secrecy requirements referred to in Article 73, resolution authorities and competent authorities shall inform ESMA of all administrative penalties imposed by them under Article 81 and of the status of any appeal against such penalties and the outcome thereof. 2. ESMA shall maintain a central database of administrative penalties reported to it solely for the purpose of exchange of information between resolution authorities which shall be accessible to resolution authorities only and shall be updated on the basis of the information provided by resolution authorities. 3. ESMA shall maintain a central database of administrative penalties reported to it solely for the purpose of exchange of information between competent authorities which shall be accessible to competent authorities only and shall be updated on the basis of the information provided by competent authorities. 4. ESMA shall maintain a webpage on its existing website with links to each resolution authority\u2019s publication of administrative penalties and each competent authority\u2019s publication of administrative penalties under Article 83 and indicate the period for which each Member State publishes penalties. Article 85 Exercise of powers to impose administrative penalties and other administrative measures and their effective application by competent authorities and resolution authorities Member States shall ensure that, when determining the type of administrative penalties or other administrative measures and the level of administrative fines, the competent authorities and resolution authorities take into account all relevant circumstances, including where appropriate: (a) the gravity and the duration of the infringement; (b) the degree of responsibility of the natural or legal person responsible; (c) the financial strength of the natural or legal person responsible, for example, as indicated by the total turnover of the responsible legal person or the annual income of the responsible natural person; (d) the amount of profits gained or losses avoided by the natural or legal person responsible, insofar as they can be determined; (e) the losses for third parties caused by the infringement, insofar as they can be determined; (f) the level of cooperation of the natural or legal person responsible with the competent authority and the resolution authority; (g) previous infringements by the natural or legal person responsible; (h) any potential systemic consequences of the infringement. TITLE VIII AMENDMENTS TO REGULATIONS (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 AND (EU) 2015/2365 AND DIRECTIVES 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU AND (EU) 2017/1132 Article 86 Amendments to Regulation (EU) No 1095/2010 Regulation (EU) No 1095/2010 is amended as follows: (1) in point (3) of Article 4, the following point is added: \u2018(iv) with regard to Regulation (EU) 2021/23 of the European Parliament and of the Council (*), a resolution authority as defined in point (3) of Article 2 of that Regulation. (*) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).\u2019;\" (2) in Article 40(5), the following subparagraph is added: \u2018For the purpose of acting within the scope of Regulation (EU) 2021/23, the member of the Board of Supervisors referred to in point (b) of paragraph 1 may, where appropriate, be accompanied by a representative from the resolution authority in each Member State, who shall be non-voting.\u2019. Article 87 Amendments to Regulation (EU) No 648/2012 Regulation (EU) No 648/2012 is amended as follows: (1) the following Article is inserted: \u2018Article 6b Suspension of clearing obligation in the case of resolution 1. Where a CCP meets the conditions under Article 22 of Regulation (EU) 2021/23 of the European Parliament and of the Council (*), the resolution authority of the CCP designated under Article 3(1) of that Regulation or the competent authority designated in accordance with Article 22(1) of this Regulation may, on their own initiative or at the request of a competent authority responsible for the supervision of a clearing member of the CCP under resolution, request that the Commission suspend the clearing obligation referred to in Article 4(1) of this Regulation for specific classes of OTC derivatives or for a specific type of counterparty where the following conditions are met: (a) the CCP under resolution is authorised to clear the specific classes of OTC derivatives subject to the clearing obligation for which the suspension is requested; and (b) the suspension of the clearing obligation for those specific classes of OTC derivatives or for a specific type of counterparty is necessary to avoid or address a serious threat to financial stability or to the orderly functioning of financial markets in the Union in connection with the resolution of the CCP, and that suspension is proportionate to those aims. The request referred to in the first subparagraph shall be accompanied by evidence that the conditions laid down in points (a) and (b) of that subparagraph are met. The authority referred to in the first subparagraph shall notify its reasoned request to ESMA and the ESRB at the same time that the request is submitted to the Commission. 2. ESMA shall, within 24 hours of notification of the request from the authority referred to in the first subparagraph of paragraph 1 of this Article, and, to the extent possible, after consulting the ESRB, issue an opinion on the intended suspension taking into account the necessity to avoid or address a serious threat to financial stability or to the orderly functioning of financial markets in the Union, the resolution objectives laid down in Article 21 of Regulation (EU) 2021/23 and the criteria set out in Article 5(4) and (5) of this Regulation. 3. Where the suspension of the clearing obligation is considered by ESMA to be a material change in the criteria for the trading obligation to take effect referred to in Article 32(5) of Regulation (EU) No 600/2014, ESMA may request the Commission to suspend the trading obligation laid down in Article 28(1) and (2) of that Regulation for the same specific classes of OTC derivatives that are subject to the request to suspend the clearing obligation. ESMA shall submit its reasoned request to the authority referred to in the first subparagraph of paragraph 1 and the ESRB at the same time the request is submitted to the Commission. 4. The requests referred to in paragraphs 1 and 3 and the opinion referred to in paragraph 2 shall not be made public. 5. The Commission shall, without undue delay after receipt of the request referred to in paragraph 1, on the basis of the reasons and evidence provided by the authority referred to in paragraph 1, either suspend the clearing obligation for the specific classes of OTC derivatives by way of an implementing act, or reject the requested suspension. In adopting the implementing act referred to in the first subparagraph, the Commission shall take into account the opinion issued by ESMA referred to in paragraph 2 of this Article, the resolution objectives referred to in Article 21 of Regulation (EU) 2021/23, the criteria set out in Article 5(4) and (5) of this Regulation regarding those OTC derivative classes and the necessity of the suspension to avoid or address a serious threat to financial stability or the orderly functioning of financial markets in the Union. Where the Commission rejects the requested suspension, it shall provide reasons therefor in writing to the requesting authority referred to in the first subparagraph of paragraph 1 and to ESMA. The Commission shall immediately inform the European Parliament and the Council thereof and forward them the reasons provided to the requesting authority referred to in the first subparagraph of paragraph 1 and to ESMA. Such information shall not be made public. The implementing act referred to in the first subparagraph of this paragraph shall be adopted in accordance with the procedure referred to in Article 86(3). 6. Where requested by ESMA in accordance with paragraph 3 of this Article, the implementing act suspending the clearing obligation may also suspend the trading obligation laid down in Article 28(1) and (2) of Regulation (EU) No 600/2014 for the same specific classes of OTC derivatives that are subject to the suspension of the clearing obligation. 7. The suspension of the clearing obligation and, where applicable, of the trading obligation shall be communicated to the requesting authority referred to in the first subparagraph of paragraph 1 of this Article and to ESMA and shall be published in the Official Journal of the European Union, on the Commission\u2019s website and in the public register referred to in Article 6. 8. The suspension of the clearing obligation pursuant to paragraph 5 shall be valid for an initial period of no more than three months from the date of application of that suspension. The suspension of the trading obligation referred to in paragraph 6 shall be valid for the same initial period. 9. Where the grounds for the suspension continue to apply, the Commission may, by way of an implementing act, extend the suspension referred to in paragraph 5 for additional periods of no more than three months, with the total period of the suspension of no more than 12 months. Any extensions of the suspension shall be published in accordance with paragraph 7. The implementing act referred to in the first subparagraph of this paragraph shall be adopted in accordance with the procedure referred to in Article 86(3). 10. Any of the authorities referred to in the first subparagraph of paragraph 1 may, in sufficient time before the end of the initial suspension period referred to in paragraph 5, or the extension period referred to in paragraph 9, issue a request to the Commission to extend the suspension of the clearing obligation. The request shall be accompanied by evidence that the conditions laid down in points (a) and (b) of the first subparagraph of paragraph 1 continue to be met. The authority referred to in the first subparagraph shall notify its reasoned request to ESMA and the ESRB at the same time that the request is notified to the Commission. The request referred to in the first subparagraph shall not be made public. ESMA shall without undue delay after the receipt of the notification of the request and, if it deems necessary, after consulting the ESRB, issue an opinion to the Commission on whether the grounds for the suspension continue to apply taking into account the necessity to avoid or address a serious threat to financial stability or the orderly functioning of financial markets in the Union, the resolution objectives laid down in Article 21 of Regulation (EU) 2021/23 and the criteria set out in Article 5(4) and (5) of this Regulation. ESMA shall send a copy of that opinion to the European Parliament and to the Council. That opinion shall not be made public. The implementing act extending the suspension of the clearing obligation may also extend the period of the suspension of the trading obligation referred to in paragraph 6. The extension of the suspension of the trading obligation shall be valid for the same period as the extension of the suspension of the clearing obligation. (*) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).\u2019;\" (2) the following Article is inserted: \u2018Article 13a Replacement of interest rate benchmarks in legacy trades 1. Counterparties referred to in Article 11(3) may continue to apply the risk-management procedures that they have in place at the date of application of this Regulation in respect of non-centrally cleared OTC derivative contracts entered into or novated before the date on which the obligation to have risk-management procedures pursuant to Article 11(3) takes effect where, after 11 February 2021, those contracts are novated for the sole purpose of replacing the interest rate benchmark they are referring to or of introducing fallback provisions in relation to that benchmark. 2. Transactions entered into or novated before the date on which the clearing obligation takes effect pursuant to Article 4 and which, after 11 February 2021, are subsequently novated for the sole purpose of replacing the interest rate benchmark they are referring to or of introducing fallback provisions in relation to that benchmark, shall not, for that reason, become subject to the clearing obligation referred to in Article 4.\u2019; (3) in Article 24a(7), point (b) is replaced by the following: \u2018(b) at least annually, initiate and coordinate Union-wide assessments of the resilience of CCPs to adverse market developments in accordance with Article 32(2) of Regulation (EU) No 1095/2010, taking into account, where possible, the aggregate effect of CCP recovery and resolution arrangements on Union financial stability;\u2019; (4) in Article 28, paragraph 3 is replaced by the following: \u20183. The risk committee shall advise the board on any arrangements that may impact the risk management of the CCP, such as a significant change in its risk model, the default procedures, the criteria for accepting clearing members, the clearing of new classes of instruments, or the outsourcing of functions. The risk committee shall inform the board in a timely manner of any new risk affecting the resilience of the CCP. The advice of the risk committee is not required for the daily operations of the CCP. Reasonable efforts shall be made to consult the risk committee on developments impacting the risk management of the CCP in emergency situations, including on developments relevant to clearing members\u2019 exposures to the CCP and interdependencies with other CCPs.\u2019; (5) in Article 28, paragraph 5 is replaced by the following: \u20185. A CCP shall promptly inform the competent authority and the risk committee of any decision in which the board decides not to follow the advice of the risk committee and explain such decision. The risk committee or any member of the risk committee may inform the competent authority of any areas in which it considers that the advice of the risk committee has not been followed.\u2019; (6) in Article 37(2), the following subparagraph is added: \u2018The CCP shall inform the competent authority of any significant negative development regarding the risk profile of any of its clearing members determined in the context of the CCP\u2019s assessment referred to in the first subparagraph or any other assessment with similar conclusion, including any increase in the risk that any of its clearing members brings to the CCP, which the CCP considers to have the potential of triggering a default procedure.\u2019; (7) in Article 38, the following paragraph is added: \u20188. The clearing members of the CCP shall clearly inform their existing and potential clients of the potential losses or other costs that they may bear as a result of the application of default management procedures and loss and position allocation arrangements under the CCP\u2019s operating rules, including the type of compensation they may receive, taking into account Article 48(7). Clients shall be provided with sufficiently detailed information to ensure that they understand the worst-case losses or other costs they could face should the CCP undertake recovery measures.\u2019; (8) the following Article is inserted: \u2018Article 45a Temporary restrictions in the case of a significant non-default event 1. In the case of a significant non-default event as defined in point (9) of Article 2 of Regulation (EU) 2021/23, the competent authority may require the CCP to refrain from any of the following actions for a period specified by the competent authority, that cannot exceed five years: (a) making a dividend distribution or give an irrevocable commitment to make a dividend distribution, except for rights to dividends specifically referred to in Regulation (EU) 2021/23 as a form of compensation; (b) buy-back of ordinary shares; (c) creating an obligation to pay variable remuneration as defined by the CCP\u2019s remuneration policy pursuant to Article 26(5) of this Regulation, discretionary pension benefits or severance packages to senior management as defined in point 29 of Article 2 of this Regulation. The competent authority shall not restrict the CCP from undertaking any of the actions referred to in the first subparagraph, if the CCP is legally obliged to undertake that action and the obligation predates the events pursuant to the first subparagraph. 2. The competent authority may decide to waive the restrictions in paragraph 1 where it deems that waiving those restrictions would not reduce the quantity or availability of the CCP\u2019s own resources, in particular own resources available for use as a recovery measure. 3. ESMA shall by 12 February 2022 draft guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 further specifying the circumstances in which the competent authority may require the CCP to refrain from undertaking any of the actions referred to in paragraph 1 of this Article.\u2019; (9) in Article 81(3), first subparagraph, the following point is added: \u2018(r) the resolution authorities designated under Article 3 of Regulation (EU) 2021/23.\u2019. Article 88 Amendment to Regulation (EU) 2015/2365 In Article 12(2), the following point is added: \u2018(n) the resolution authorities designated under Article 3 of Regulation (EU) 2021/23 of the European Parliament and of the Council (*). Article 89 Amendments to Directive 2002/47/EC Directive 2002/47/EC is amended as follows: (1) in Article 1, paragraph 6 is replaced by the following: \u20186. Articles 4 to 7 of this Directive shall not apply to any restriction on the enforcement of financial collateral arrangements or any restriction on the effect of a security financial collateral arrangement, any close out netting or set-off provision that is imposed by virtue of Title IV, Chapter V or VI of Directive 2014/59/EU of the European Parliament and of the Council (*), or of Title V, Chapter III, Section 3, or Chapter IV of Regulation (EU) 2021/23 of the European Parliament and of the Council (**) or to any such restriction that is imposed by virtue of similar powers in the law of a Member State to facilitate the orderly resolution of any entity referred to in point (c)(iv) or (d) of paragraph 2 of this Article which is subject to safeguards at least equivalent to those set out in Title IV, Chapter VII of Directive 2014/59/EU or in Title V, Chapter V of Regulation (EU) 2021/23. (*) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190).\" (**) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).\u2019;\" (2) Article 9a is replaced by the following: \u2018Article 9a Directive 2008/48/EC, Directive 2014/59/EU and Regulation (EU) 2021/23 This Directive shall be without prejudice to Directive 2008/48/EC, Directive 2014/59/EU and Regulation (EU) 2021/23.\u2019. Article 90 Amendment to Directive 2004/25/EC In Article 4(5), the third subparagraph is replaced by the following: \u2018Member States shall ensure that Article 5(1) of this Directive does not apply in the case of application of resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU of the European Parliament and of the Council (*) or in Title V of Regulation (EU) 2021/23 of the European Parliament and of the Council (**). Article 91 Amendments to Directive 2007/36/EC Directive 2007/36/EC is amended as follows: (1) in Article 1, paragraph 4 is replaced by the following: \u20184. Member States shall ensure that this Directive does not apply in the case of the application of resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU of the European Parliament and of the Council (*) or in Title V of Regulation (EU) 2021/23 of the European Parliament and of the Council (**). (*) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190).\" (**) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).\u2019;\" (2) in Article 5, paragraph 5 is replaced by the following: \u20185. Member States shall ensure that for the purposes of Directive 2014/59/EU and Regulation (EU) 2021/23 the general meeting may, by a majority of two-thirds of the votes validly cast, issue a convocation to a general meeting, or modify the statutes to prescribe that a convocation to a general meeting is issued, at shorter notice than as laid down in paragraph 1 of this Article, to decide on a capital increase, provided that that meeting does not take place within ten calendar days of the convocation, that the conditions of Article 27 or 29 of Directive 2014/59/EU or of Article 18 of Regulation (EU) 2021/23 are met, and that the capital increase is necessary to avoid the conditions for resolution laid down in Articles 32 and 33 of Directive 2014/59/EU or in Article 22 of Regulation (EU) 2021/23.\u2019. Article 92 Amendment to Directive (EU) 2017/1132 Directive (EU) 2017/1132 is amended as follows: (1) in Article 84, paragraph 3 is replaced by the following: \u20183. Member States shall ensure that Article 49, Article 58(1), Article 68(1), (2) and (3), the first subparagraph of Article 70(2), Articles 72 to 75, 79, 80 and 81 of this Directive do not apply in the case of application of the resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU of the European Parliament and of the Council (*) or in Title V of Regulation (EU) 2021/23 of the European Parliament and of the Council (**). (*) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190).\" (**) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).\u2019;\" (2) Article 86a is amended as follows: (a) point (b) of paragraph 3 is replaced by the following: \u2018(b) the company is subject to resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU or in Title V of Regulation (EU) 2021/23.\u2019; (b) point (c) of paragraph 4 is replaced by the following: \u2018(c) the subject of crisis prevention measures as defined in point (101) of Article 2(1) of Directive 2014/59/EU or in point (48) of Article 2 of Regulation (EU) 2021/23.\u2019; (3) in Article 87, paragraph 4 is replaced by the following: \u20184. Member States shall ensure that this Chapter does not apply to companies which are the subject of the application of resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU or in Title V of Regulation (EU) 2021/23.\u2019; (4) Article 120 is amended as follows: (a) point (b) of paragraph 4 is replaced by the following: \u2018(b) the company is subject to resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU or in Title V of Regulation (EU) 2021/23.\u2019; (b) point (c) of paragraph 5 is replaced by the following: \u2018(c) the subject of crisis prevention measures as defined in point (101) of Article 2(1) of Directive 2014/59/EU or in point (48) of Article 2 of Regulation (EU) 2021/23.\u2019; (5) Article 160a is amended as follows: (a) point (b) of paragraph 4 is replaced by the following: \u2018(b) the company is subject to resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU or in Title V of Regulation (EU) 2021/23.\u2019; (b) point (c) of paragraph 5 is replaced by the following: \u2018(c) the subject of crisis prevention measures as defined in point (101) of Article 2(1) of Directive 2014/59/EU or in point (48) of Article 2 of Regulation (EU) 2021/23.\u2019. Article 93 Amendment to Directive 2014/59/EU In Article 1, the following paragraph is added: \u20183. This Directive shall not apply to entities that are also authorised in accordance with Article 14 of Regulation (EU) No 648/2012.\u2019. Article 94 Amendment to Regulation (EU) No 806/2014 Article 2 is amended as follows: (a) the first subparagraph is numbered as paragraph 1; (b) the following paragraph is added: \u20182. This Regulation shall not apply to entities that are also authorised in accordance with Article 14 of Regulation (EU) No 648/2012.\u2019. Article 95 Amendment to Regulation (EU) No 600/2014 In Article 54(2), the first subparagraph is replaced by the following: \u2018If the Commission assesses that there is no need to exclude exchange-traded derivatives from the scope of Articles 35 and 36 in accordance with Article 52(12), a CCP or a trading venue may, before 11 February 2021, apply to its competent authority for permission to avail itself of transitional arrangements. The competent authority, taking into account the risks resulting from the application of the access rights under Article 35 or 36 as regards exchange-traded derivatives to the orderly functioning of the relevant CCP or trading venue, may decide that Article 35 or 36 would not apply to the relevant CCP or trading venue, respectively, in respect of exchange-traded derivatives, for a transitional period until 3 July 2021. Where such a transitional period is approved, the CCP or trading venue shall not benefit from the access rights under Article 35 or 36, as regards exchange-traded derivatives for the duration of that period. The competent authority shall notify ESMA and, in the case of a CCP, the college of competent authorities for that CCP, when a transitional period is approved.\u2019. TITLE IX FINAL PROVISIONS Article 96 Review By 12 February 2024, ESMA shall assess the staffing and resources needs arising from the assumption of its powers and duties in accordance with this Regulation and submit a report to the European Parliament, to the Council and to the Commission. By 12 February 2026, the Commission shall review the implementation of this Regulation and shall submit a report thereon to the European Parliament and to the Council. It shall assess at least the following: (a) the appropriateness and sufficiency of financial resources available to the resolution authority to cover losses arising from a non-default event; (b) the amount of own resources of the CCP to be used in recovery and in resolution and the means for its use; and (c) whether the resolution tools available to the resolution authority are adequate. Where appropriate, that report shall be accompanied by proposals for revision of this Regulation. By 31 December 2021, the Commission shall review the application of Article 27(7). The Commission shall assess in particular the need for any further amendments with regard to the application of the write-down and conversion tool in the event of resolution of CCPs in combination with other resolution tools that result in financial losses being borne by clearing members. The Commission shall submit a report thereon to the European Parliament and to the Council accompanied where appropriate by proposals for revision of this Regulation. By 12 August 2027, the Commission shall review this Regulation and its implementation and shall assess the effectiveness of the governance arrangements for the recovery and resolution of CCPs in the Union and submit a report thereon to the European Parliament and to the Council, accompanied where appropriate by proposals for revision of this Regulation. Article 97 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 12 August 2022 with the exception of: Article 95 which shall apply from 4 July 2020; Article 87(2) which shall apply from 11 February 2021; Articles 9(1), 9(2), 9(3), 9(4), 9(6), 9(7), 9(9), 9(10), 9(12), 9(13), 9(16), 9(17), 9(18), 9(19), 10(1), 10(2), 10(3), 10(8), 10(9), 10(10), 10(11), 10(12) and 11 which shall apply from 12 February 2022; Articles 9(14) and 20 which shall apply from 12 February 2023. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 December 2020. For the European Parliament President D. M. SASSOLI For the Council President M. ROTH (1) OJ C 209, 30.6.2017, p. 28. (2) OJ C 372, 1.11.2017, p. 6. (3) Position of the European Parliament of 27 March 2019 (not yet published in the Official Journal) and Position of the Council at first reading of 17 November 2020 (not yet published in the Official Journal). Position of the European Parliament of 14 December 2020 (not yet published in the Official Journal). (4) Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1). (5) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190). (6) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (7) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12). (8) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1). (9) Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (OJ L 166, 11.6.1998, p. 45). (10) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338). (11) Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84). (12) Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, p. 1). (13) Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (OJ L 168, 27.6.2002, p. 43). (14) Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, p. 46). (15) Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (OJ L 142, 30.4.2004, p. 12). (16) Directive 2007/36/EC of the European Parliament and of the Council of 11 July 2007 on the exercise of certain rights of shareholders in listed companies (OJ L 184, 14.7.2007, p. 17). (17) Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, p. 1). (18) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (19) Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, p. 1). (20) Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (OJ L 168, 27.6.2002, p. 43). (21) Directive (EU) 2019/2162 of the European Parliament and of the Council of 27 November 2019 on the issue of covered bonds and covered bond public supervision and amending Directives 2009/65/EC and 2014/59/EU (OJ L 328, 18.12.2019, p. 29). (22) Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring special tasks on the European Central Bank concerning policies to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63). (23) Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48). (24) Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12). (25) Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities (OJ L 184, 6.7.2001, p. 1). (26) Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (OJ L 390, 31.12.2004, p. 38). ANNEX SECTION A Requirements for recovery plans The recovery plan shall include the following items: (1) a summary of the key elements of the plan and a summary of overall recovery capacity; (2) a summary of the material changes to the CCP since the most recently filed recovery plan; (3) a communication and disclosure plan outlining how the CCP intends to keep its competent authority informed of the recovery situation and manage any potentially negative market reactions while acting in as transparent a manner as possible; (4) a comprehensive range of capital, loss allocation, position allocation and liquidity actions required to maintain or restore the viability and financial soundness of the CCP including to restore its matched book and capital, and replenish pre-funded resources and maintain access to sufficient sources of liquidity which are necessary for the CCP to maintain its viability as a going concern and to continue providing its critical services in accordance with the delegated acts adopted on the basis of Articles 16(3) and 44(2) of Regulation (EU) No 648/2012. Loss allocation actions may include recovery cash calls and a reduction in the value of gains payable by the CCP to non-defaulting clearing members, where defined in the operating rules of the CCP, and shall not use the initial margins posted by non-defaulting clearing members to allocate losses in accordance with Article 45(4) of Regulation (EU) No 648/2012; (5) an assessment of the recovery options with respect to: (i) the impact of their implementation on the solvency, liquidity, funding positions, profitability and operations of the CCP; (ii) the external impact and systemic consequences of their implementation on critical functions, shareholders, clearing members, creditors and other stakeholders of the CCP, and where applicable, the rest of the group, and to the extent the information is available, clients and indirect clients of the CCP; (iii) the feasibility of their implementation, following a detailed analysis of risks, impediments and solutions for the impediments; and (iv) the impact of their implementation on the continuity of operations, in particular human resources and IT, and access to other financial infrastructures. (6) appropriate conditions and procedures to ensure the timely implementation of recovery actions, including an estimation of the timeframe for implementing each material aspect of the plan; (7) a detailed description of any material impediment to the effective and timely implementation of the plan, including consideration of the impact on clearing members and clients including in cases where clearing members are likely to take measures in accordance with their recovery plans as referred to in Articles 5 and 7 of Directive 2014/59/EU, and where appropriate on the rest of the group; (8) an assessment of the appropriateness of the recovery options to address each relevant recovery plan scenario, based on how those options: (i) ensure transparency and allow those who could be exposed to losses and liquidity shortfalls to measure, manage and control such potential losses and shortfalls; (ii) provide incentives to shareholders, clearing members and their clients and the financial system; and (iii) minimise negative impact on clearing members and their clients and the financial system; (9) identification of critical functions; (10) a detailed description of the processes for determining the value and marketability of the core business lines, operations and assets of the CCP; (11) a detailed description of how recovery planning is integrated into the corporate governance structure of the CCP, how it forms part of the operating rules of the CCP agreed to by clearing members, as well as the policies and procedures governing the approval of the recovery plan and identification of the persons in the organisation responsible for drawing up and implementing the plan; (12) arrangements and measures incentivising non-defaulting clearing members to bid competitively in auctions of a defaulted members\u2019 positions; (13) arrangements and measures to ensure that the CCP has adequate access to contingency funding sources, including potential liquidity sources, to enable it to continue to carry out its operations and meet its obligations as they fall due; (14) an assessment of available collateral and an assessment of the possibility to transfer resources or liquidity across business lines; (15) arrangements and measures: (i) to reduce risk; (ii) to restructure contracts, rights, assets and liabilities; (iii) to restructure business lines; (iv) necessary to maintain continuous access to FMIs and trading venues; (v) necessary to maintain the continuous functioning of the CCP\u2019s operational processes, including infrastructure and IT services; (vi) to partially or fully terminate contracts; (vii) to reduce the value of any gains payable by the CCP to non-defaulting clearing members, if applicable, depending on the type of instruments that the CCP clears; and (viii) to oblige non-defaulting clearing members to make a contribution in cash to the CCP up to at least each clearing member\u2019s contribution to the default fund. This recovery cash call obligation shall also be included and referred to in the CCP\u2019s rules and other contractual arrangements; (16) preparatory arrangements to facilitate the sale of assets or business lines in a timeframe appropriate for the restoration of financial soundness, including an assessment of the potential impact of such a sale on the operations of the CCP; (17) where other management actions or strategies to restore financial soundness are envisaged, a description of those actions or strategies and their anticipated financial effect; (18) preparatory measures that the CCP has taken or plans to take in order to facilitate the implementation of the recovery plan, including those necessary to enable the timely recapitalisation of the CCP, restoring its matched book and replenishment of its pre-funded resources as well as its enforceability across borders; (19) a framework of quantitative and qualitative indicators which identifies the points at which appropriate actions referred to in the plan may be taken; (20) where applicable, an analysis of how and when the CCP may apply, in the conditions addressed in the plan, for the use of central bank facilities and identify those assets that would be expected to qualify as collateral under the terms of the central bank facility; (21) taking into account Article 49(1) of Regulation (EU) No 648/2012, a range of scenarios that would severely affect the financial soundness or operational viability of the CCP and be relevant to the CCP\u2019s specific conditions such as its product mix, business model and liquidity and risk governance framework, including scenarios involving system-wide events or events specific to the legal entity and any group to which it belongs and specific stress to the individual clearing members of the CCP or, where appropriate, a linked FMI; and (22) taking into account Article 34, and Article 49(1), of Regulation (EU) No 648/2012, a range of scenarios that would severely affect the financial soundness or operational viability of the CCP and result both from the stress or default of one or more of its members, including scenarios going beyond the stress or default of at least the two clearing members to which the CCP has the largest exposures under extreme but plausible market conditions, and from other reasons including losses from the CCP\u2019s investment activities or from operational problems, including severe external threats to a CCP\u2019s operations due to an external disruption, shock or cyber-related incident. SECTION B Information that resolution authorities may request CCPs to provide for the purposes of drawing up and maintaining resolution plans For the purposes of drawing up and maintaining resolution plans, resolution authorities may request CCPs to provide at least the following information: (1) a detailed description of the CCP\u2019s organisational structure including a list of all legal persons; (2) identification of the direct holders and the percentage of voting and non-voting rights of each legal person; (3) the location, jurisdiction of incorporation, licensing and key management associated with each legal person; (4) a mapping of the CCP\u2019s critical functions and core business lines, including balance sheet details of such functions and business lines, by reference to legal persons; (5) a detailed description of the components of the CCP\u2019s and all its legal entities\u2019 business activities, separating, at a minimum by types of services and respective amounts of cleared volumes, open interest, initial margin, variation margin flows, default funds and any associated assessment rights or other recovery actions pertaining to such business lines; (6) details of capital and debt instruments issued by the CCP and its legal entities; (7) an identification of from whom the CCP has received collateral and in what form (title transfer or security interest), and to whom it has pledged collateral and in what form and the person that holds the collateral, and in both cases the jurisdiction in which the collateral is located; (8) a description of the off balance sheet exposures of the CCP and its legal entities, including a mapping to its critical operations and core business lines; (9) the material hedges of the CCP including a mapping to legal persons; (10) identification of the relative exposures and importance of clearing members of the CCP as well as an analysis of the impact of the failure of major clearing members on the CCP; (11) each system on which the CCP conducts a material number or value amount of trades, including a mapping to the CCP\u2019s legal persons, critical operations and core business lines; (12) each payment, clearing or settlement system of which the CCP is directly or indirectly a member, including a mapping to the CCP\u2019s legal persons, critical operations and core business lines; (13) a detailed inventory and description of the key management information systems, including those for risk management, accounting and financial and regulatory reporting used by the CCP including a mapping to the CCP\u2019s legal persons, critical operations and core business lines; (14) an identification of the owners of the systems identified in point (13), service level agreements related thereto, and any software and systems or licenses, including a mapping to their legal entities, critical operations and core business lines; (15) an identification and mapping of the legal persons and the interconnections and interdependencies among the different legal persons such as: (i) common or shared personnel, facilities and systems; (ii) capital, funding or liquidity arrangements; (iii) existing or contingent credit exposures; (iv) cross-guarantee agreements, cross-collateral arrangements, cross-default provisions and cross-affiliate netting arrangements; (v) risks transfers and back-to-back trading arrangements; (vi) service level agreements; (16) the competent authority and resolution authority for each legal person, if different to those designated under Article 22 of Regulation (EU) No 648/2012 and under Article 3 of this Regulation; (17) the member of the board responsible for providing the information necessary to draw up the resolution plan of the CCP as well as those responsible, if different, for the different legal persons, critical operations and core business lines; (18) a description of the arrangements that the CCP has in place to ensure that, in the event of resolution, the resolution authority will have all the necessary information, as determined by the resolution authority, for applying the resolution tools and exercising the resolution powers; (19) all the agreements entered into by the CCP and their legal entities with third parties the termination of which may be triggered by a decision of the authorities to apply a resolution tool and whether the consequences of termination may affect the application of the resolution tool; (20) a description of possible liquidity sources for supporting resolution; (21) information on asset encumbrance, liquid assets, off-balance sheet activities, hedging strategies and booking practices. SECTION C Matters that the resolution authority is to consider when assessing the resolvability of a CCP When assessing the resolvability of a CCP, the resolution authority shall consider the following: (1) the extent to which the CCP is able to map core business lines and critical operations to legal persons; (2) the extent to which legal and corporate structures are aligned with core business lines and critical operations; (3) the extent to which the legal structure of the CCP inhibits the application of the resolution tools as a result of the number of legal persons, the complexity of the group structure or the difficulty in aligning business lines to group entities; (4) the extent to which there are arrangements in place to provide for essential staff, infrastructure, funding, liquidity and capital to support and maintain the core business lines and the critical operations; (5) the existence and robustness of service level agreements; (6) the extent to which the service agreements that the CCP maintains are fully enforceable in the event of resolution of the CCP; (7) the extent to which the governance structure of the CCP is adequate for managing and ensuring compliance with the CCP\u2019s internal policies with respect to its service level agreements; (8) the extent to which the CCP has a process for transitioning the services provided under service level agreements to third parties in the event of the separation of critical functions or of core business lines; (9) the extent to which there are contingency plans and measures in place to ensure continuity in access to payment and settlement systems; (10) the adequacy of the management information systems in ensuring that the resolution authorities are able to gather accurate and complete information regarding the core business lines and critical operations so as to facilitate rapid decision making; (11) the capacity of the management information systems to provide the information essential for the effective resolution of the CCP at all times even under rapidly changing conditions; (12) the extent to which the CCP has tested its management information systems under stress scenarios as defined by the resolution authority; (13) the extent to which the CCP can ensure the continuity of its management information systems both for the affected CCP and the new CCP in the case that the critical operations and core business lines are separated from the rest of the operations and business lines; (14) the extent to which any intra-group guarantees are provided at market conditions and the risk management systems concerning those guarantees are robust, where the CCP benefits from or is exposed to such guarantees; (15) the extent to which any intra-group transactions are performed at market conditions and the risk management systems concerning those transactions practices are robust, where the CCP engages in such transactions; (16) the extent to which the use of any intra-group guarantees or transactions increases contagion across the group; (17) the extent to which the resolution of the CCP could have a negative impact on another part of its group, in particular where such group comprises other FMIs, where applicable; (18) whether third-country authorities have the resolution tools necessary to support resolution actions by Union resolution authorities, and the scope for coordinated action between Union and third-country authorities; (19) the feasibility of applying resolution tools in such a way which meets the resolution objectives, given the tools available and the CCP\u2019s structure; (20) any specific requirements needed to issue new instruments of ownership as referred to in Article 33(1); (21) the arrangements and means through which resolution could be hampered in the cases of CCP that have clearing members or collateral arrangements established in different jurisdictions; (22) the credibility of applying resolution tools in such a way which meets the resolution objectives, given possible impacts on clearing members and, where applicable, their clients, other counterparties and employees and possible actions that third-country authorities may take; (23) the extent to which the impact of the CCP\u2019s resolution on the financial system and on financial market\u2019s confidence can be adequately evaluated; (24) the extent to which the resolution of the CCP could have a significant direct or indirect adverse effect on the financial system, market confidence or the economy; (25) the extent to which contagion to other CCPs or to the financial markets could be contained through the application of the resolution tools and the exercise of the resolution powers; and (26) the extent to which the resolution of the CCP could have a significant effect on the operation of payment and settlement systems.", "summary": "Recovery and resolution of central counterparties Recovery and resolution of central counterparties SUMMARY OF: Regulation (EU) 2021/23 on a framework for the recovery and resolution of central counterparties WHAT IS THE AIM OF THE REGULATION? It lays down rules and procedures for the recovery and resolution of central counterparties (CCPs)*. These are designed to ensure CCPs have measures to recover from financial distress or can continue their main tasks if they are failing, or likely to fail, while winding up other activities through normal insolvency procedures. The overall aim is to preserve financial stability and minimise the costs to taxpayers of any CCP failure. KEY POINTS Each European Union (EU) Member State has the following responsibilities. Appointing one or more resolution authorities. These:may be national central banks, ministries or public authorities with administrative powers;have the expertise, resources, operational capacity and extensive powers to act quickly and flexibly. Designating a single ministry with overall responsibility for exercising the functions entrusted to the ministries under the legislation. Applying penalties for breaches of the regulation. Resolution authorities establish, manage and chair a resolution college. This includes the relevant authorities and provides a framework to: share information; draw up resolution plans; assess a CCP\u2019s resolvability and possible obstacles; coordinate public information about resolution plans and strategies. The European Securities and Markets Authority (ESMA): drafts various regulatory technical standards that will be adopted by the European Commission; creates the ESMA Resolution Committee that will promote the drawing up and coordination of resolution plans and develop methods for the resolution of failing CCPs; cooperates with the European Insurance and Occupational Pensions Authority and the European Banking Authority; maintains a central database of national penalties applied for breaches of the legislation. Competent authorities, resolution authorities and ESMA: cooperate closely to carry out the tasks set out in the regulation; base decisions on principles such as: proportionality in view of the CCP\u2019s legal form, size, complexity and liquidity,the need for efficacy and timeliness, the need to keep down costs and, as far as possible, avoid use of public finance. Recovery planning requires CCPs to draw up and maintain a recovery plan. These: set out actions, with or without a default, to restore financial soundness; include measures to address all possible risks, absorb losses and replenish financial resources; contain indicators based on a CCP\u2019s risk profile; do not assume access to public finance or central bank liquidity; consider the interests of all stakeholders; ensure clearing members do not have unlimited exposure to the CCP. It also requires the competent authority, supervisory college and resolution authority to assess the recovery plans and consider any changes. Resolution planning requires the following. The resolution authority of the CCP has to draw up a resolution plan that: sets out how it would use its resolution powers to absorb losses and ensure the continuity of the CCP\u2019s critical functions;takes account of the impact of the plan on clearing members, financial markets and the financial system;does not assume access to public finance or central bank help;makes prudent assumptions about finance that might be available. CCPs under resolution have to cooperate with the resolution authority and provide all the necessary information; The resolution college has to agree on the plan, including any changes, within 4 months of receiving it. Assessing resolvability requires the resolution authority, coordinating with the resolution college, to: assess whether a CCP is resolvable, to enable it to continue operating its critical functions; identify any obstacles to resolvability and instruct the CCP to take action to remove them. Early intervention measures enable a competent authority to instruct a CCP it considers could be facing financial problems to: take corrective action; remove some or all of senior management or board members. Resolution authorities take special account of the following when implementing their plans. Objectives: continuity of the CCP\u2019s critical functions; avoidance of damage to the financial system; protection of public funds. Conditions: CCP actual or likely failure; absence of alternative private sector solution; importance of protecting the public interest. Valuation: two assessments to ensure a fair, prudent and realistic appreciation of the CCP\u2019s assets, liabilities, rights and obligations. Safeguards: shareholders, clearing members and other creditors should not lose more than if the resolution authority had not intervened (\u2018No creditor worse off\u2019 principle); clients and indirect clients have the right to compensation clearing members may receive; anyone affected by a crisis prevention order or resolution action has a right of appeal. Resolution authorities can apply the following measures, individually or collectively. Position and loss allocation. Terminating contracts, reducing a CCP\u2019s payment obligations to non-defaulting clearing members or requiring the latter to make a cash contribution to the CCP. Write-down and conversion. Reducing or converting the size of instruments of ownership, debt or other unsecured liabilities, requiring a CCP to provide and implement a business reorganisation plan. Sale of business. Selling ownership or any assets, rights, obligations or liabilities of a CCP in the resolution procedure. Bridge CCP. Transferring temporarily to another CCP (\u2018bridge CCP\u2019) ownership or any assets, rights, obligations or liabilities of a CCP in the resolution procedure. Alternative funding. Contracting to borrow or obtain other forms of financing to address temporary cash flow problems. Member States may, if a CCP failure threatens a systemic crisis, inject cash or take it into public ownership (government stabilisation tools), provided the measures are temporary and comply with EU State aid rules. The regulation amends the following: Regulations (EU) No 1095/2010 (see summary), (EU) No 648/2012 (see summary), (EU) No 600/2014 (see summary), (EU) No 806/2014 (see summary) and (EU) 2015/2365 (see summary); Directives 2002/47/EC (see summary), 2004/25/EC (see summary), 2007/36/EC (see summary), 2014/59/EU (see summary) and (EU) 2017/1132 (see summary). Under the review procedure: ESMA assesses its staffing and resources needs by 12 February 2024; the Commission submits a report on the legislation to the European Parliament and the Council of the European Union by 12 February 2026. FROM WHEN DOES THE REGULATION APPLY? It entered into force on 11 February 2021 and applies from 12 August 2022 with the exception of a few articles that apply earlier. BACKGROUND Central counterparties are an essential part of the financial system as they manage a significant amount of counterparty risk and act as a link between multiple banks, other financial counterparties and corporations. The adoption of the European market infrastructure regulation, Regulation (EU) No 648/2012, ensured CCPs helped increase market transparency following the 2008 financial crisis. For further information, see: Recovery and resolution of central counterparties (CCPs) (European Commission). KEY TERMS Central counterparty. An entity that interposes itself between the counterparties to the contracts traded on one or more financial markets, becoming the buyer to every seller and the seller to every buyer. MAIN DOCUMENT Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 22, 22.1.2021, pp. 1\u2013102). RELATED DOCUMENTS Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, pp. 46\u2013127). Successive amendments to Directive (EU) 2017/1132 have been incorporated in the original text. This consolidated version is of documentary value only. Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, pp. 1\u201334). Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, pp. 1\u201390). See consolidated version. Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, pp. 190\u2013348). See consolidated version. Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, pp. 84\u2013148). See consolidated version. Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, pp. 1\u201359). See consolidated version. Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, pp. 84\u2013119). See consolidated version. Directive 2007/36/EC of the European Parliament and of the Council of 11 July 2007 on the exercise of certain rights of shareholders in listed companies (OJ L 184, 14.7.2007, pp. 17\u201324). See consolidated version. Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (OJ L 142, 30.4.2004, pp. 12\u201323). See consolidated version. Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (OJ L 168, 27.6.2002, pp. 43\u201350). See consolidated version. last update 09.02.2022"}
{"article": "28.12.2020 EN Official Journal of the European Union L 437/108 DECISION (EU) 2020/2228 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 December 2020 on a European Year of Rail (2021) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) In its communication of 11 December 2019, entitled \u2018The European Green Deal\u2019 (the \u2018communication on the European Green Deal\u2019), the Commission set out a European Green Deal for the Union and its citizens. The European Green Deal is a new growth strategy that aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use. (2) In its conclusions of 12 December 2019, the European Council endorsed the objective of achieving a climate-neutral Union by 2050. (3) In its resolution of 15 January 2020, the European Parliament welcomed the communication on the European Green Deal and called for the necessary transition to a climate-neutral society by 2050. (4) In line with the objectives set out in the communication on the European Green Deal, there is a need to transform the Union economy and to rethink policies, in particular in the field of transport and mobility. Transport accounts for a quarter of the Union\u2019s greenhouse gas emissions, a share that is still growing. To achieve climate neutrality, a 90 % reduction in transport emissions is needed by 2050. Achieving sustainable intermodal transport requires putting users first and providing them with more affordable, accessible, healthier, cleaner and more energy-efficient alternatives to their current mobility habits, while encouraging those who are already using sustainable transport modes, such as walking, cycling and public transport. (5) The European Green Deal implies accelerating the shift to sustainable and smart mobility in order to address those challenges. In particular, a substantial part of the 75 % of inland freight carried today by road should be shifted onto rail and inland waterways. For that shift to take place, significant investments are needed, including investments made in the context of the recovery, and an essential part of them will relate to the implementation of the Trans-European Transport Network (TEN-T) and efforts to increase the efficiency of the rail freight corridors. (6) Rail has a significant role to play as a game changer in achieving the climate neutrality objective by 2050. It is one of the most environmentally friendly and energy-efficient transport modes. Rail is largely electrified and emits far less CO2 than equivalent travel by road or air. It is the only transport mode that has consistently reduced its greenhouse gas emissions and CO2 emissions since 1990. In addition, rail has decreased its energy consumption between 1990 and 2016 and increasingly uses renewable energy sources. (7) The COVID-19 crisis has hit the transport sector exceptionally hard. Despite operational and financial constraints, the sector has maintained crucial connections both for the transport of people and of essential goods. This has been possible mainly thanks to the employees who have continued working under difficult and uncertain conditions. The strategic role played by rail during the COVID-19 crisis has highlighted that achieving the single European railway area, established by Directive 2012/34/EU of the European Parliament and of the Council (4), is necessary both for facilitating the supply of essential goods, such as food, medicines and fuel, particularly in exceptional circumstances, and for achieving wider transport policy objectives. (8) By connecting the Union\u2019s main transport routes with its peripheral, mountainous and remote regions and territories, including at regional and local level, and by establishing and reinstating missing regional cross-border rail links, the rail sector contributes to social, economic and territorial cohesion on continental, national, regional and local level. Furthermore, in remote and rural areas, the networks that guarantee the provision of basic services to the population are often fewer in number and less well-developed. Peripheral regions are often faced with the doubly difficult situation of being rural in character and at the periphery of national networks. (9) While the share of rail passengers in Union land transport has only slightly increased since 2007, the share of rail freight has decreased. Many obstacles remain to achieving a true single European railway area. The rail sector is sometimes hampered inter alia by outdated business and operational practices, by ageing infrastructure and rolling stock and by noisy wagons. Overcoming those obstacles together with reducing costs, studying Union schemes to supplement national mechanisms for non-discriminatory support for rail operators, and accelerating innovation will allow rail to realise its full potential, while ensuring the functioning of the internal market, increasing rail traffic and further improving the already high safety levels. The rail sector therefore needs a further boost to become more attractive to travellers, employees and businesses alike. (10) Transport ministers from a majority of Member States expressed their commitment to supporting a European agenda for international passenger rail, through a political statement presented at the informal video conference of EU transport ministers on 4 June 2020. (11) In order to promote rail transport in line with the objectives set out in the communication on the European Green Deal, including with regard to sustainable and smart mobility, the year 2021 should be designated as the European Year of Rail (the \u2018European Year\u2019). The year 2021 will be important for the Union rail policy, since it will represent the first full year where the rules agreed under the Fourth Railway Package will be implemented throughout the Union, namely on the opening of the market of domestic passenger services, on reducing costs and administrative burden for railway undertakings operating across the Union and on providing the European Union Agency for Railways (ERA) with additional tasks that aim to lower technical barriers. There is a growing public interest in railways, including in night trains, in a number of Member States, as illustrated by the popularity of DiscoverEU. Moreover, the international arts festival Europalia will dedicate its 2021 edition to the influence of railways on the arts and highlight the role of rail as a powerful promotor of social, economic, industrial and ecological change. The European Year should contribute to a pan-European debate on the future of railways. (12) At Union level, the necessary financial allocation for the implementation of this Decision will involve appropriate funding to be determined in the context of the budgetary procedure for 2021 in accordance with the 2021 to 2027 multiannual financial framework. Without prejudice to the powers of the budgetary authority, the aim should be to provide funding for the implementation of this Decision from 1 January 2021 to 31 December 2022 of at least EUR 8 million. (13) Commuters account for 80 % to 90 % of all rail passengers. This means that urban agglomerations are significant contributors to the overall performance of passenger rail transport. Smart urban mobility depends on modernising and renovating under-used suburban and regional lines to deliver low ecological impact and social and economic cohesion. (14) During the European Year, the Commission should consider initiating a study on the feasibility of creating a European label to promote goods and products transported by rail so as to encourage businesses to switch their transport to rail. Likewise, the Commission should consider initiating a feasibility study with a view to introducing a rail connectivity index, with the aim of categorising the level of integration achieved through the use of services on the rail network. (15) The role of motivated staff cannot be overestimated, since they guarantee the smooth running of operations. In order to reach its full potential, the rail sector needs to diversify its workforce and, in particular, to attract women and young workers. That policy should be promoted at all institutional levels. (16) Enhancing the attractiveness of rail requires services to be user-centred and to be organised and designed in a way that delivers good value, consistent dependability, excellent quality of service and attractive pricing. (17) Since the objectives of this Decision, namely to promote rail transport as a sustainable, innovative, interconnected and intermodal, safe and affordable mode of transport and as an important element in maintaining and developing good relations between the Union and its neighbouring countries, as well as to highlight the European, cross-border dimension of rail and to enhance the contribution of rail to the Union economy, industry and society, cannot be sufficiently achieved by the Member States but can rather, by reason of the need for transnational exchange of information and Union-wide dissemination of best practices, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS DECISION: Article 1 Subject matter The year 2021 shall be designated as the \u2018European Year of Rail\u2019 (the \u2018European Year\u2019). Article 2 Objectives The general objective of the European Year shall be to encourage and support the efforts of the Union, Member States, regional and local authorities, and other organisations to increase the share of passengers and freight moving by rail. The specific objectives of the European Year shall be to: (a) promote rail as a sustainable, innovative, interconnected and intermodal, safe and affordable mode of transport, in particular by highlighting the role of rail: (i) as a game changer helping to achieve the Union\u2019s climate neutrality objective by 2050; (ii) as a pillar of an efficient logistic network, capable of guaranteeing essential services, even during unexpected crises; and (iii) as a transport mode that reaches out to the wider public, especially the young, inter alia presenting rail as an attractive career opportunity; (b) highlight the European, cross-border dimension of rail, that brings citizens closer together, allows them to explore the Union in all its diversity, fosters socio-economic and territorial cohesion and contributes to integrating the Union internal market, in particular by ensuring better connectivity within and with its geographical periphery, including through regional cross-border connections; (c) enhance the contribution of rail to the Union\u2019s economy, to its industry, including to its global competitiveness, to its commerce and to its society, in particular those aspects related to regional and local development, sustainable tourism, education, youth and culture, and to improving accessibility for persons with disabilities or persons with reduced mobility, and in particular paying attention to the needs of elderly people; (d) contribute to promoting rail as an important element in relations between the Union and its neighbouring countries, building on interests and needs in partner countries and on expertise in rail transport, both within and beyond the Union; (e) build on rail\u2019s power to stimulate the collective imagination, particularly through rail\u2019s history and its cultural heritage, recalling the contribution that rail has made to the creation of European prosperity and the role of the rail in developing cutting-edge technologies; (f) promote the attractiveness of the railway professions, in particular by highlighting the demand for new skills and the importance of fair and safe working conditions and of addressing the need to increase diversity in the workforce; (g) promote the key role of railways in international passenger transport within the Union; (h) promote a Union night train network and encourage initiatives that underline its cross-border nature by using symbols that represent the Union; (i) create public awareness of rail\u2019s potential role in the development of sustainable tourism in Europe; (j) promote the key role of railways in sustainable end-to-end mobility, connecting hubs and allowing attractive and smart transfer between modes of transport; (k) contribute to the implementation of the Fourth Railway Package and to raising awareness of the measures required to establish the single European railway area, based on a well-functioning TEN-T; (l) stimulate discussion on how to modernise rolling stock and on how to further develop and increase the capacity of railway infrastructure in order to facilitate the broader use of passenger and freight transport by rail, underlining in that context the importance of the cooperation among infrastructure managers, research and innovation and the role of the Shift2Rail Joint Undertaking established by Council Regulation (EU) No 642/2014 (5); (m) promote events and initiatives to disseminate information on the rights of rail passengers and to stimulate cooperation among all actors in order to improve customer information and ticketing, including the offer of through-tickets and developing innovative digital multi-modal tickets, as well as to provide information about current challenges in that respect, such as the need for data sharing among actors. Article 3 Content of measures 1. The measures to be taken to achieve the objectives set out in Article 2 shall be closely coordinated with on-going activities promoting rail transport. Those measures shall include the following activities at Union, national, regional or local level, organised in partnerships or individually, and linked to the objectives of the European Year: (a) initiatives and events to promote debate, build a positive image, raise awareness and facilitate the engagement of citizens, businesses and public authorities in order to increase trust in rail, particularly in the aftermath of the COVID-19 crisis, and to promote the attractiveness of rail for the transport of more people and goods as a means of combating climate change, through multiple channels and tools, including events in Member States, while also highlighting the safety and comfort of travelling by rail; (b) initiatives in Members States to encourage, in both the public and private sector, business-travel and commuting patterns by rail; (c) informative exhibitions, inspirational, educational and awareness-raising campaigns, as well as the use of demonstration and information trains to encourage changes in passenger, consumer and business behaviour and to stimulate the general public to actively contribute to achieving the objectives of more sustainable transport; (d) sharing the experience and best practices of national, regional and local authorities, civil society, businesses and schools as regards promoting the use of rail and on how to implement behavioural change at all levels; (e) undertaking studies and innovative activities, and disseminating their results on a European or national scale; (f) promoting projects and networks related to the European Year, including via the media, social networks and other online communities; (g) partnerships and events such as those set out in the Annex; (h) identifying and promoting best practices to create a level-playing field for different modes of transport; (i) promoting projects and activities to raise awareness of sustainable end-to-end mobility that delivers seamless \u2018door-to-door\u2019 travel solutions in combination with other modes of transport, including active travel, and sustainable and smart logistics; (j) promoting projects and activities fostering awareness of the importance of the single European railway area, in particular as regards its on-going implementation, actions facilitating international railway journeys and actions for digital passenger information, such as those providing real-time information about journey offers, fares and timetables, including from independent providers, facilitating comparison; and (k) promoting projects and activities with a view to the realisation of an extended, modernised and interoperable railway infrastructure, including a European Rail Traffic Management System (ERTMS), terminals offering modal shift options, as well as modernised rolling stock. 2. The Commission shall consider initiating, during the European Year: (a) a study on the feasibility of creating a European label to promote goods and products transported by rail so as to encourage businesses to switch their transport to rail; and (b) a feasibility study with a view to introducing a rail connectivity index, with the aim of categorising the level of integration achieved through the use of services on the rail network and showing the potential of rail to compete with other modes of transport. By 31 March 2021, the Commission shall inform the European Parliament and the Council of its plans. 3. The Union institutions and bodies, as well as Member States, at Union and national level respectively, may refer to the European Year and make use of its visual identity in promoting the activities referred to in paragraph 1. Article 4 Coordination at Member State level The organisation of participation in the European Year at national level is a responsibility of Member States. They shall ensure the coordination of relevant activities at national level and shall appoint national contact persons to ensure coordination at Union level. Article 5 Coordination at Union level 1. The Commission shall regularly convene meetings of the national contact persons in order to coordinate the running of the European Year. Those meetings shall also serve as opportunities to exchange information regarding the implementation of the European Year at Union and national level. Representatives of the European Parliament may participate in those meetings as observers. 2. The coordination of the European Year at Union level shall be transversal in approach with a view to creating synergies between the various Union programmes and initiatives that fund projects in the field of rail transport or that have a rail dimension. 3. The Commission shall convene regular meetings of stakeholders and representatives of organisations or bodies active in the field of rail transport, including existing transnational networks, relevant non-governmental organisations, universities and technology centres, as well as representatives of youth organisations and communities, organisations representing persons with disabilities and persons with reduced mobility, to assist it in implementing the European Year at Union level. 4. The Commission may, if the budget allows, organise calls for proposals and projects that can receive support for their outstanding contribution to the objectives of the European Year. Article 6 International cooperation For the purpose of the European Year, the Commission shall, where necessary, cooperate with competent international organisations, while ensuring the visibility of the Union\u2019s participation. Article 7 Monitoring and evaluation By 31 December 2022, the Commission shall submit a report to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions on the implementation, results and overall assessment of the initiatives provided for in this Decision. For the evaluation of the initiatives, the Commission shall establish key performance indicators. Those key performance indicators shall be set out in the Commission\u2019s report. For the purpose of that report, Member States shall provide information to the Commission on the activities for which they have been responsible. Article 8 Entry into force This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union. Done at Brussels, 23 December 2020. For the European Parliament The President D. M. SASSOLI For the Council The President M. ROTH (1) OJ C 364, 28.10.2020, p. 149. (2) Opinion of 14 October 2020 (not yet published in the Official Journal). (3) Position of the European Parliament of 15 December 2020 (not yet published in the Official Journal) and decision of the Council of 17 December 2020. (4) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32). (5) Council Regulation (EU) No 642/2014 of 16 June 2014 establishing the Shift2Rail Joint Undertaking (OJ L 177, 17.6.2014, p. 9). ANNEX PARTNERSHIPS AND EVENTS This Annex sets out the following indicative list of partnerships and events linked to the European Year: (1) partnerships with film festivals throughout Europe to highlight the prominent place of rail in cinema production; (2) cooperation with European railway museums and existing cultural events such as film festivals and art exhibitions; (3) partnerships with ERA to emphasise: (a) the performance of the rail sector in Europe; (b) the know-how of actors in the rail sector, in particular of rail workers; (c) the advantages of rail in terms of safety and environmental protection; and (d) career opportunities in the rail sector for pupils, students and apprentices; (4) mobile exhibition trains in the Union to inform the public about the objectives of the European Year and to highlight the attractiveness of its many messages; (5) provision of Interrail passes for young people in connection with Erasmus studies or competitions to extend the reach of the European Year; (6) the use of stations as places of art, urban meeting places and economic, cultural and civic hub, and the use of railway museums to relay the messages of the European Year.", "summary": "European Year of Rail (2021) European Year of Rail (2021) SUMMARY OF: Decision (EU) 2020/2228 on a European Year of Rail (2021) WHAT IS THE AIM OF THE DECISION? In line with the objectives of the European Green Deal (see summary), the main aim of the European Year of Rail is to encourage and support the efforts of the European Union (EU), EU countries, regional and local authorities and other organisations to increase the share of passengers and freight moving by rail. KEY POINTS Objectives The decision has a number of specific objectives, including: to promote rail as a sustainable, innovative, interconnected and intermodal, safe and affordable mode of transport, specifically by highlighting the role of rail: as a game changer helping to achieve the EU\u2019s climate-neutrality objective by 2050,as a pillar of an efficient logistics network, capable of guaranteeing essential services, even during unexpected crises,as a transport mode that reaches out to the wider public, especially the young, including by presenting rail as an attractive career opportunity; to highlight the European, cross-border dimension of rail, which brings citizens closer together; to enhance the contribution of rail to the EU\u2019s economy, industry and society; to promote the key role of railways in international passenger transport within the EU and beyond; to contribute to implementing the fourth railway package and to raising awareness of the measures required to establish the single European railway area (see summary), based on a properly functioning trans-European transport network. Measures A number of measures at the EU, national, regional and local levels are planned to achieve these objectives. They will be coordinated with existing efforts to promote rail transport. These measures include: initiatives and events to promote debate, build a positive image, raise awareness and facilitate the engagement of citizens, businesses and public authorities to increase trust in rail, particularly in the aftermath of the COVID-19 crisis, and to promote the attractiveness of rail for the transport of more people and goods as a means of combating climate change; initiatives in EU countries to encourage, in both the public and private sectors, business travel and commuting patterns by rail; informative exhibitions and inspirational, educational and awareness-raising campaigns. The European Commission will also consider feasibility studies on: creating a European label to promote goods and products transported by rail to encourage businesses to switch their transport to rail; introducing a rail connectivity index, with the aim of categorising the level of integration achieved through the use of services on the rail network and showing the potential of rail to compete with other modes of transport. FROM WHEN DOES THE DECISION APPLY? It has applied since 29 December 2020. BACKGROUND For further information, see: European Year of Rail (European Commission). MAIN DOCUMENT Decision (EU) 2020/2228 of the European Parliament and of the Council of 23 December 2020 on a European Year of Rail (2021) (OJ L 437, 28.12.2020, pp. 108-115) RELATED DOCUMENTS Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 The European Green Deal (COM(2019) 640 final, 11.12.2019) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, pp. 32-77) Successive amendments to Directive 2012/34/EU have been incorporated into the original text. This consolidated version is of documentary value only. last update 08.03.2021"}
{"article": "20.10.2020 EN Official Journal of the European Union L 348/1 COUNCIL DECISION (CFSP) 2020/1515 of 19 October 2020 establishing a European Security and Defence College, and repealing Decision (CFSP) 2016/2382 THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on European Union, and in particular Articles 28(1) and 42(4) thereof, Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy, Whereas: (1) On 18 July 2005, the Council adopted Joint Action 2005/575/CFSP (1) establishing the European Security and Defence College ('ESDC'). That Joint Action was replaced on 23 June 2008 by Council Joint Action 2008/550/CFSP (2), which, in turn, was replaced by Council Decision 2013/189/CFSP (3). Finally, Decision 2013/189/CFSP was replaced by Council Decision (CFSP) 2016/2382 (4). (2) On 10 and 11 November 2008, the Council adopted the European Young Officers Exchange Scheme, inspired by the Erasmus programme and agreed that an implementing working party will meet within the framework of the Executive Academic Board of the ESDC. (3) On 26 June 2020, the ESDC Steering Committee ('Steering Committee') agreed on recommendations on the future perspectives of the ESDC. (4) Whilst the staff of the ESDC should consist mainly of seconded national experts, it may be necessary to fill certain critical posts by contracted staff members. (5) Pursuant to Council Decision 2010/427/EU (5), which establishes the organisation and functioning of the European External Action Service (EEAS), the EEAS should provide the ESDC with the support previously provided by the General Secretariat of the Council. (6) Decision (CFSP) 2016/2382 should therefore be repealed, HAS ADOPTED THIS DECISION: CHAPTER I Establishment, mission, objectives and tasks Article 1 Establishment A European Security and Defence College (ESDC) is hereby established. Article 2 Mission The ESDC shall provide training and education in the field of the Union's Common Security and Defence Policy (CSDP) in the wider context of the Common Foreign and Security Policy (CFSP) at European level in order to develop and promote a common understanding of CFSP and CSDP among civilian and military personnel and to identify and disseminate best practices in relation to various CFSP and CSDP, issues through its training and education activities ('ESDC training and education activities'). Article 3 Objectives The ESDC shall have the following objectives: (a) to further enhance the common European security and defence culture within the Union and to promote the principles laid down in Article 21(1) of the Treaty on European Union (TEU) outside the Union; (b) to promote a better understanding of CSDP as an essential part of CFSP; (c) to provide Union instances with knowledgeable personnel able to work efficiently on all CSDP matters within the wider context of CFSP; (d) to provide Member States' administrations and staff with knowledgeable personnel familiar with Union policies, institutions and procedures in the field of CSDP; (e) to provide CSDP Missions' and Operations' personnel with a common understanding of CSDP Missions' and Operations' functioning principles and a sense of common European identity; (f) to provide training and education responding to training and educational needs of CSDP Missions and Operations; (g) to support Union partnerships in the field of CSDP, in particular partnerships with those countries participating in CSDP missions; (h) to support civilian crisis management including in the field of conflict prevention, and establishing or preserving the conditions necessary for sustainable development; (i) to promote the European Initiative for the Exchange of Young Officers; (j) to promote PhD-level research in domains related to CSDP; (k) to provide Member States' and Union administrations with knowledgeable personnel familiar with Union policies, institutions, procedures and best practices in the field of cyber security and defence; (l) to help promote professional relations and contacts among training and education participants. Where appropriate, attention shall be paid to ensuring consistency with other activities of the Union. Article 4 Tasks of the ESDC 1. The main tasks of the ESDC shall be, in accordance with its mission and objectives, to organise and conduct ESDC training and education activities in the field of the CSDP in the wider context of CFSP. 2. The ESDC training and education activities shall include: (a) basic and advanced level courses promoting generic understanding of CFSP and CSDP; (b) courses developing leadership; (c) courses directly supporting CSDP Missions and Operations, including pre\u2010deployment and in-mission/in-operation training and education; (d) courses supporting EU partnerships and countries participating in CSDP Missions and Operations; (e) modules supporting civilian and military training and education in the field of CSDP; (f) CSDP courses, seminars, programmes and conferences for specialised audiences or with specific focus; (g) common modules run under the European Initiative for the Exchange of Young Officers, inspired by the Erasmus programme; although formally not ESDC training and education activities, the ESDC will also support and promote European semesters and joint master's degrees making use of the common modules referred to in this point; (h) cyber awareness and advanced level courses, including in support of CSDP missions and operations; (i) courses and seminars aimed at supporting PhD-level research through exchange of best practices and experience. Other training and education activities shall be undertaken, as decided by the Steering Committee referred to in Article 9. 3. In addition to the activities referred to in paragraph 2 of this Article, the ESDC shall, in particular: (a) support the relations to be established between the institutes referred to in Article 5(1) engaged in the network referred to in that paragraph ('the network'); (b) run and further develop an e-Learning system to support CSDP training and education activities or, in exceptional circumstances, be used as stand-alone training and education activities; (c) develop and produce training and educational material in the field of CSDP also drawing on already existing relevant material; (d) support an Alumni Association between former training participants; (e) support exchange programmes in the field of CSDP between the Member States' training and educational institutes; (f) act as compartment administrator of the Schoolmaster module of the Goalkeeper project and provide contributions to the annual Union Training Programme in CSDP through this module; (g) act as administrator of the Union-instance of the CD-TXP platform for the exchange of cyber related training opportunities; (h) provide support to the management of training and education in the field of conflict prevention, civilian crisis management, establishing or preserving the conditions necessary for sustainable development and Security Sector Reform initiatives, as well as promotion of cyber security and hybrid threats' awareness; (i) organise and run an annual network conference bringing together civilian and military training and education experts in CFSP and CSDP from Member States' training and educational institutes and ministries, and relevant external training and education actors as appropriate; (j) maintain relationships with relevant actors in the field of Freedom Security and Justice, in the field of Development and Cooperation, and with relevant International Organisations; (k) support the Committee for Civilian Aspects of Crisis Management and the EU Civilian Training Group by administering and managing the travel and accommodation costs relating to the activities of the Civilian Coordinators for Training; (l) participate in the meetings of the Union civilian and military training groups, derive civilian/military training requirements from their output and take the results of the requirements analysis into account during the annual prioritisation exercise of ESDC activities and for the development of ESDC curricula; and (m) further elaborate, maintain and promote the sectoral qualification framework for military officers. CHAPTER II Organisation Article 5 Network 1. The ESDC shall be organised as a network bringing together civilian and military institutes, colleges, academies, universities, institutions, centres of excellence and other actors dealing with security and defence policy issues within the Union as identified by Member States, as well as the European Union Institute for Security Studies (EUISS). The ESDC shall establish close links with the Union institutions and relevant Union agencies, in particular with, but not limited to: \u2014 the Union Agency for law enforcement training (CEPOL), \u2014 the European Border and Coast Guard Agency (FRONTEX), \u2014 the European Defence Agency (EDA), \u2014 the European Satellite Centre (EU SatCen), and \u2014 the European Union Agency for Law Enforcement Cooperation (Europol). 2. Where appropriate, international, intergovernmental, governmental or non-governmental organisations may obtain the status of 'associate network partner' (ANP), the detailed arrangements for which will be agreed by the Steering Committee. 3. The ESDC shall work under the overall responsibility of the High Representative of the Union for Foreign Affairs and Security Policy ('HR'). Article 6 Role of European Union Institute for Security Studies 1. As part of the ESDC network, the EUISS shall cooperate with the ESDC by making its expertise and knowledge-gathering capabilities available for ESDC training activities, including through EUISS publications, within the limits of its own capabilities. 2. In particular, the EUISS shall provide lectures given by EUISS analysts and contribute to the further development of the ESDC e-Learning content. 3. The EUISS shall support the ESDC Alumni Association. Article 7 Legal capacity 1. The ESDC shall have the necessary legal capacity in order to: (a) fulfil its tasks and meet its objectives; (b) enter into contracts and administrative arrangements necessary for its functioning including to implement staff secondments and recruit contract staff; acquire equipment, in particular teaching equipment; (c) hold bank accounts; and (d) be a party to legal proceedings. 2. Any liability that may arise from contracts concluded by the ESDC, shall be covered by the funds available to it pursuant to Articles 16 and 17. Article 8 Structure The following structure shall be set up under the ESDC: (a) the Steering Committee with responsibility for the overall coordination and direction of the ESDC training and education activities; (b) the Executive Academic Board ('the Board') with responsibility for ensuring the quality and coherence of the ESDC training and education activities; (c) the Head of the ESDC ('the Head'), sole legal representative of the ESDC, with responsibility for the financial and administrative management of the ESDC, as well as advising the Steering Committee and the Board on the organisation and management of ESDC activities; (d) the ESDC Secretariat ('the Secretariat') which is to assist the Head in fulfilling the Head's tasks and in particular in assisting the Board to ensure the overall quality and coherence of the ESDC training and education activities. Article 9 Steering Committee 1. The Steering Committee shall be composed of one representative appointed by each Member State and shall be the decision-making body of the ESDC. Each member of the Committee may be represented or accompanied by an alternate member. 2. Members of the Steering Committee may be accompanied by experts to meetings of the Committee. 3. The Steering Committee shall be chaired by a representative of the HR who has appropriate experience. It shall meet at least four times a year. 4. Representatives from countries acceding to the Union may attend the Steering Committee's meetings as active observers. 5. The Head, other ESDC staff, the Chairperson of the Board and, when appropriate, the Chairpersons of its different configurations as well as a representative of the Commission and other Union institutions, including EEAS, shall participate in the meetings of the Steering Committee without the right to vote. 6. The tasks of the Steering Committee shall be to: (a) approve and keep under regular review the ESDC training and education activities reflecting the agreed CSDP training and education requirements; (b) approve the annual academic programme of the ESDC; (c) select and prioritise the training and education activities to be run under the ESDC, taking into account the resources made available to the ESDC and the training and education requirements identified; (d) select the Member State(s) hosting the ESDC training and education activities and the institutes conducting them; (e) decide on opening specific ESDC training and education activities to third- country participation within the general political framework set by the Political and Security Committee; (f) adopt the curricula for all ESDC training and education activities; (g) take note of the course evaluation reports; (h) take note of the general annual report on ESDC training and education activities and adopt the recommendations therein, to be forwarded to the relevant Council bodies; (i) provide overall guidance to the work of the Board; (j) appoint the Chairpersons of the Board and its different configurations; (k) take the necessary decisions with regard to the functioning of the ESDC in so far as these are not attributed to other bodies; (l) approve the annual budget and any amending budget, acting on proposals from the Head; (m) approve the annual accounts and give a discharge to the Head; (n) approve additional rules applicable to expenditure managed by the ESDC; (o) approve any financing agreement and/or technical arrangement with the Commission, the EEAS, a Union Agency or a Member State regarding the financing and/or the implementation of the ESDC expenditure; (p) contribute to the selection process of the Head as defined in Article 11(3); (q) evaluate the performance of his or her tasks by the Head as regards the potential extension of his or her mandate as referred in Article 11(4). 7. The Steering Committee shall approve its Rules of Procedure. 8. Except for the case provided for in Article 2(6) of the Financial Rules applicable to expenditure funded by the ESDC and to the financing of the expenditure of the ESDC, which are set out in the Annex to this Decision (the \"Financial Rules\"), the Steering Committee shall act by qualified majority, as defined in Article 16(4) TEU. Article 10 Executive Academic Board 1. The Board shall be composed of senior representatives from those civilian and military institutes and other actors identified by Member States to support the conduct of ESDC training and education activities and of the Director of EUISS or the Director's representative. 2. The Chairperson of the Board shall be appointed by the Steering Committee among the members of the Board. 3. Representatives of the Commission and of EEAS shall be invited to attend the meetings of the Board. 4. Senior representatives of the associate network partners shall be invited to attend the meetings of the Board as active observers. 5. Academic experts and senior officials from Union and national institutions may be invited to attend the meetings of the Board, as observers. When appropriate and on a case-by-case basis, academic experts and senior officials who are representatives of institutes that are not a member of the network may be invited to participate in the meetings of the Board. 6. The tasks of the Board shall be to: (a) provide academic advice and recommendations to the Steering Committee; (b) implement, through the network, the agreed annual academic programme; (c) oversee the e-Learning system; (d) develop curricula for all ESDC training and education activities; (e) ensure general coordination of ESDC training and education activities among all institutes; (f) review standards of the training and education activities undertaken in the previous academic year; (g) submit proposals to the Steering Committee for training and education activities in the next academic year; (h) ensure a systematic evaluation of all ESDC training and education activities and approve the course evaluation reports; (i) contribute to the draft general annual report on ESDC activities; (j) support the implementation of the European Initiative for the Exchange of Young Officers, inspired by the Erasmus programme. 7. To fulfil its tasks, the Board may meet in different project-focused configurations. The Board shall draw up the rules and arrangements governing the creation and functioning of these configurations to be agreed by the Steering Committee. Each configuration shall report its activities back to the overall Board at least once every year, after which its mandate may be extended. 8. Members of the Secretariat shall support and assist the Board and each of its configurations. Those members shall attend the meetings without the right to vote. If no other candidate can be identified, a member may, at the same time, chair the meetings. 9. The Rules of Procedure of the Board and each of its configurations shall be adopted by the Steering Committee. Article 11 Head of the ESDC 1. The Head shall: (a) be responsible for the ESDC activities; (b) be the sole legal representative of the ESDC; (c) be responsible for the financial and administrative management of the ESDC; (d) advise the Steering Committee and the Board and support their work; and (e) act as the representative of the ESDC for training and education activities within and outside the network. 2. Candidates for the position of Head shall be persons with recognised long\u2010standing expertise and experience in training and education. Member States may put forward candidates for the position of Head. Staff of the Union institutions and the EEAS may apply for this position, in accordance with the applicable rules. 3. The pre-selection process shall be organised under the responsibility of the HR. The pre-selection panel shall be composed of three representatives of the EEAS. It shall be chaired by the Chair of the Steering Committee. On the basis of the pre-selection results, the HR shall submit to that Committee a recommendation with a shortlist of at least three candidates, drawn-up in the order of the pre-selection panel's preference. At least half of the candidates on the shortlist should come from Member States. During the selection process, the candidates shall present their vision for the ESDC to that Committee, after which Member States shall be invited to rank the candidates in a written, secret vote. The Head shall be appointed by the HR as a member of the EEAS staff for a period not exceeding three years. 4. Before the end of the period referred to in paragraph 3, the performance of his or her tasks by the Head shall be evaluated by the Steering Committee, in particular against the objectives set in the vision he or she presented during the selection process. On the basis of this evaluation, that Committee shall then either propose to extend the mandate of the current head or to launch a new selection procedure to select a new Head. In the latter case, the current Head may not apply for that position. In case of extension, the total duration of the mandate of the Head shall not exceed five years. 5. The tasks of the Head shall in particular be to: (a) take all necessary steps, including the adoption of internal administrative instructions and the publication of notices, to ensure the effective functioning of ESDC activities; (b) draw up the preliminary draft annual report of the ESDC and its preliminary draft work programme to be submitted to the Steering Committee on the basis of the proposals submitted by the Board; (c) co-ordinate the implementation of the ESDC work programme; (d) maintain contacts with the relevant authorities in Member States; (e) maintain contacts with relevant external training and education actors in the field of CFSP and CSDP; (f) conclude where necessary technical arrangements on ESDC training and education activities with the relevant authorities and training and education actors in the field of CFSP and CSDP; (g) perform any other task attributed to him or her by the Steering Committee. 6. The Head shall be responsible for the financial and administrative management of the ESDC, and in particular shall: (a) draw up and submit to the Steering Committee any draft budget; (b) adopt the budgets after their approval by the Steering Committee; (c) be the authorising officer for the ESDC budget; (d) open one or more bank accounts on behalf of the ESDC; (e) negotiate, submit to the Steering Committee and conclude any financing agreement and/or technical arrangement with the Commission, the EEAS or a Member State regarding the financing and/or the implementation of the ESDC expenditure; (f) select the staff of the Secretariat, assisted by a selection panel; (g) negotiate and sign on behalf of the ESDC any Exchange of Letters for the secondment to the ESDC of Secretariat staff; (h) negotiate and sign on behalf of the ESDC any contract of employment for staff paid from the ESDC budget; (i) generally, represent the ESDC for the purpose of all legal acts with financial implications; (j) submit to the Steering Committee the ESDC annual accounts. 7. The Head shall be accountable to the Steering Committee for his or her activities. Article 12 ESDC Secretariat 1. The Secretariat shall assist the Head in fulfilling the tasks of the Head. 2. The Secretariat shall provide support to the Steering Committee, to the Board including its configurations and to institutes for the management, coordination and organisation of the ESDC training and education activities. 3. The Secretariat shall support and assist the Board in ensuring the overall quality and coherence of ESDC training and education activities and in ensuring that they remain in line with the Union's policy developments. In particular, they shall help to ensure that all steps in the delivery of a training and education activity, from curriculum development and the content to the methodologic approach, shall reflect the highest possible standards. 4. Each institute forming the ESDC network shall designate a point of contact with the Secretariat to deal with the organisational and administrative issues connected with the organisation of the ESDC training and education activities. 5. The Secretariat shall closely co-operate with the Commission and the EEAS. Article 13 ESDC Staff 1. The ESDC staff shall consist of: (a) staff seconded to the ESDC by Union institutions, the EEAS and Union agencies; (b) national experts seconded to the ESDC by Member States; (c) contracted staff when no national expert has been identified and following approval by the Steering Committee. 2. The ESDC may receive interns and visiting fellows. 3. The number of ESDC staff shall be decided by the Steering Committee together with the budget for the next year and have a clear link to the number of ESDC training and education activities and other tasks as defined in Article 4. 4. The Decision of the HR establishing the rules applicable to national experts seconded to the EEAS shall be applicable mutatis mutandis to national experts seconded to the ESDC by Member States. The Staff Regulations of Officials of the European Union and the Conditions for Employment of Other Servants of the European Union (6), shall apply for personnel seconded to the ESDC by Union institutions, including for contracted staff paid from the ESDC budget. 5. The Steering Committee, acting on a proposal from the HR, shall define in so far as necessary the conditions applicable to interns and visiting fellows. 6. ESDC staff cannot conclude contracts or engage in any kind of financial obligations on behalf of the ESDC without prior written authorisation by the Head. CHAPTER III Financing Article 14 Contributions in kind to training and education activities 1. Each Member State, Union institution, Union agency and institute, and EEAS shall bear all costs related to its participation in the ESDC, including salaries, allowances, travel and subsistence expenses and costs related to organisational and administrative support of the ESDC training and education activities. 2. Each participant in ESDC training and education activities shall bear all costs related to his or her participation. Article 15 Support by the EEAS 1. The EEAS shall bear the costs arising from the hosting of the Head and the Secretariat within its premises, including information technology costs, the secondment of the Head and the secondment of one assistant staff member to the Secretariat. 2. The EEAS shall provide the ESDC with the administrative support necessary to recruit and manage its staff and to implement its budget. Article 16 Contribution from the general budget of the European Union 1. The ESDC shall receive an annual or multi-annual contribution from the general budget of the European Union. That contribution may cover, in particular, costs of supporting training and education activities and the costs of national experts seconded by Member States to the ESDC and up to one contracted staff member. 2. The financial reference amount intended to cover the expenditure of the ESDC during the period from 1 January 2021 to 31 December 2021 shall be EUR 2 055 156. The financial reference amount intended to cover the expenditure of the ESDC for subsequent periods shall be decided by the Council. 3. Following the decision by the Council as referred to in paragraph 2, a financing agreement with the Commission shall be negotiated by the Head. Article 17 Voluntary contributions 1. For the purpose of financing specific activities, the ESDC may receive and manage voluntary contributions from Member States and institutes or other donors. Such contributions shall be specifically designated by the ESDC. 2. Technical arrangements for the contributions referred to in paragraph 1 shall be negotiated by the Head. Article 18 Implementation of projects 1. The ESDC can apply for research and other projects in the field of CFSP. The ESDC can act as a project coordinator or a member. The Head can be attached to the 'advisory board' of such a project. The Head may delegate this task to one of the Chairpersons of the Board configurations or to a member of the Secretariat. 2. Contribution coming from those projects has to be made visible in the amending budget of the ESDC and used according to the tasks and objectives of the ESDC. Article 19 Financial rules The Financial Rules shall apply to expenditure funded by the ESDC and to the financing of such expenditure. CHAPTER IV Miscellaneous provisions Article 20 Participation in ESDC training and education activities 1. All ESDC training and education activities shall be open to participation by nationals of all Member States and acceding States. The organising and conducting institutes shall ensure that this principle applies without any exception. 2. The ESDC training and education activities shall also be open in principle to participation by nationals of countries that are candidates for accession to the Union and, as appropriate, of other third States and organisations, in particular for those training and education activities referred to in point (d) of Article 4(2). 3. Participants shall be civilian/diplomatic/police/military personnel dealing with aspects in the field of CSDP and CFSP, and experts to be deployed in CSDP missions or operations. Representatives of, inter alia, international organisations, non-governmental organisations, academic institutions and the media, as well as members of the business community, may be invited to participate in ESDC training and education activities. 4. A certificate signed by the HR shall be awarded to a participant who has completed an ESDC course. The modalities of the certificate shall be kept under review by the Steering Committee. The certificate shall be recognised by Member States and by the Union institutions. Article 21 Cooperation The ESDC shall cooperate with and draw on the expertise of international organisations and other relevant actors, such as national training and education institutes of third States, in particular but not limited to those referred to in Article 5(2). Article 22 Security regulations Council Decision 2013/488/EU (7) shall apply to the ESDC. CHAPTER V Final provisions Article 23 Continuity The rules and regulations adopted for the implementation of Decision (CFSP) 2016/2382 shall remain in force for the purpose of implementing this Decision in so far as they are compatible with this Decision and until they are amended or repealed. Article 24 Repeal Decision (CFSP) 2016/2382 is hereby repealed. Article 25 Review 1. No later than 20 October 2024, the Head shall initiate a review of the training and education activities, consulting all stakeholders. 2. The review shall be submitted to the Steering Committee. Article 26 Entry into force This Decision shall enter into force upon the date of adoption. Article 27 Publication This Decision shall be published in the Official Journal of the European Union. Done at Luxembourg, 19 October 2020. For the Council The President J. KLOECKNER (1) Council Joint Action 2005/575/CFSP of 18 July 2005 establishing a European Security and Defence College (ESDC) (OJ L 194, 26.7.2005, p. 15). (2) Council Joint Action 2008/550/CFSP of 23 June 2008 establishing a European Security and Defence College (ESDC) and repealing Joint Action 2005/575/CFSP (OJ L 176, 4.7.2008, p. 20). (3) Council Decision 2013/189/CFSP of 22 April 2013 establishing a European Security and Defence College (ESDC) and repealing Joint Action 2008/550/CFSP (OJ L 112, 24.4.2013, p. 22). (4) Council Decision (CFSP) 2016/2382 of 21 December 2016 establishing a European Security and Defence College (ESDC) and repealing Decision 2013/189/CFSP (OJ L 352, 23.12.2016, p. 60). (5) Council Decision 2010/427/EU of 26 July 2010 establishing the organisation and functioning of the European External Action Service (OJ L 201, 3.8.2010, p. 30). (6) Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions for Employment of Other Servants of the European Communities and instituting special measures temporarily applicable to officials of the Commission (OJ L 56, 4.3.1968, p. 1). (7) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). ANNEX FINANCIAL RULES APPLICABLE TO EXPENDITURE FUNDED BY THE ESDC AND TO THE FINANCING OF THE EXPENDITURE OF THE ESDC Article 1 Budgetary principles 1. The ESDC budget, drawn up in euro, is the act which for each financial year lays down and authorises all the ESDC revenue and all expenditure funded by the ESDC. 2. Budget revenue and expenditure shall be in balance. 3. No revenue or expenditure funded by the ESDC may be implemented other than by allocation to a heading in the ESDC budget. Article 2 Adoption of budgets 1. Each year the Head shall draw up a draft budget for the following financial year, which begins on 1 January and ends on 31 December of the same year. The draft budget shall include the appropriations deemed necessary to cover the expenditure to be funded by the ESDC during that period and a forecast of the revenue expected to cover such expenditure. 2. Appropriations shall be classified as necessary by type or purpose in chapters and articles. Detailed comments by article shall be included in the draft. 3. Revenue shall consist of Member States' or other donors' voluntary contributions as well as the annual contribution from the general budget of the European Union. 4. The Head shall submit a detailed budget report on the previous financial year by 31 March. The Head shall propose the draft budget for the following financial year to the Steering Committee by 31 July. 5. The Steering Committee shall approve the draft budget by 31 October. 6. Where the ESDC receives a multi-annual contribution from the general budget of the European Union, the Steering Committee shall approve the annual budget by consensus. Article 3 Transfers of appropriations In the event of unforeseen circumstances, transfers of appropriations between budget lines or budget headings of the contribution referred to in Article 16, not exceeding 25 % of these budget lines or headings, may be decided by the Head, who shall keep the Steering Committee informed of such transfers. Transfers of appropriations between budget lines or headings exceeding 25 % of the budget lines or headings shall be submitted to the Steering Committee in an amending budget of the ESDC for approval. Article 4 Carryovers of appropriations 1. Appropriations necessary to pay for legal obligations entered into by 31 December of a financial year shall be carried over to the next financial year. 2. Appropriations coming from voluntary contributions shall be carried over to the next financial year. 3. Appropriations coming from projects shall be carried over to the next financial year. 4. The Head may carry over other appropriations in the budget to the next financial year with the approval of the Steering Committee. 5. Other appropriations shall be cancelled at the end of the financial year. Article 5 Implementation of the budget and staff management For the purpose of implementing its budget and managing its staff, the ESDC shall use existing administrative structures of the Union, in particular the EEAS, to the greatest possible extent. Article 6 Bank accounts 1. Any ESDC bank account shall be opened at a first-rate financial institution with its head office in a Member State and shall be a current or short-term account in euro. 2. No ESDC bank account shall be overdrawn. Article 7 Payments Any payment from an ESDC bank account shall require the joint signature of the Head and another member of the ESDC staff. Article 8 Accounting 1. The Head shall ensure that accounts showing the ESDC revenue, expenditure and inventory of assets are kept in accordance with the internationally accepted accounting standards for the public sector. 2. The Head shall submit to the Steering Committee the annual accounts for a given financial year no later than the following 31 March, together with the detailed report referred to in Article 2(4) of these Financial Rules. 3. If necessary, accounting services may be outsourced. Article 9 Auditing 1. An audit of the ESDC accounts shall be conducted annually. 2. The necessary auditing services shall be outsourced. 3. The audit reports shall be made available to the Steering Committee together with the detailed report referred to in Article 2(4) of these Financial Rules. Article 10 Discharge 1. The Steering Committee shall decide on the basis of the detailed report, the annual accounts and the annual audit report whether to grant the Head a discharge in respect of the implementation of the ESDC budget. 2. The Head shall take all appropriate steps to satisfy the Steering Committee that a discharge may be granted and to act on the observations in the decisions giving discharge, if any.", "summary": "European Security and Defence College European Security and Defence College SUMMARY OF: Decision (CFSP) 2020/1515 establishing a European Security and Defence College WHAT IS THE AIM OF THE DECISION? The decision sets up the European Security and Defence College (ESDC), which aims to develop and promote a common understanding among civilians and military personnel of the common security and defence policy (CSDP) and the common foreign and security policy (CFSP) of the European Union (EU) through training and education activities. KEY POINTS Objectives The ESDC has a number of objectives, including: further enhancing the common European security and defence culture within the EU and promoting the principles set out in Article 21 of the Treaty on European Union; promoting a better understanding of CSDP as an essential part of CFSP; providing EU Member States\u2019 administrations with people who are familiar with EU policies, institutions and procedures in the CSDP field; providing CSDP missions and operations personnel with a common understanding of the functioning principles and a sense of common European identity; providing training and education that meet the needs of CSDP missions and operations; supporting EU partnerships in the field of CSDP, in particular with those countries participating in CSDP missions; supporting civilian crisis management \u2014 including in the field of conflict prevention \u2014 and establishing or preserving the conditions necessary for sustainable development; promoting the European initiative for the exchange of young officers; helping to promote professional relations and contacts among the participants. Tasks of the ESDC The main task of the ESDC is to provide training and education. The decision sets out a number of specific tasks, including: basic- and advanced-level courses that promote a generic understanding of CFSP and CSDP; leadership courses; courses that directly support CSDP missions and operations, including pre\u2010deployment and in-mission / in-operation training and education; courses that support EU partnerships and the countries participating in CSDP missions and operations; modules that support civilian and military training and education in the field of CSDP; CSDP courses, seminars, programmes and conferences for specialised audiences; common modules that run under the European initiative for the exchange of young officers, which was inspired by the Erasmus+ programme; cyber awareness and advanced courses, including in support of CSDP missions and operations; courses and seminars that support PhD-level research through the exchange of best practices and experience. Network The ESDC is organised as a network of various educational institutions \u2014 including those dealing with security and defence policies within the EU, as identified by the Member States \u2014 and the European Union Institute for Security Studies. The ESDC is closely linked with several EU institutions and agencies, including: the European Border and Coast Guard Agency \u2014 Regulation (EU) 2019/1896, see summary; the EU Agency for Law Enforcement Cooperation (Europol) \u2014 Regulation (EU) 2016/794, see summary; the EU Agency for Law Enforcement Training \u2014 Regulation (EU) 2015/2219, see summary; the European Defence Agency \u2014 Decision (CFSP) 2015/1835, see summary; the European Union Satellite Centre \u2014 Decision 2014/401/CFSP, see summary.. The ESDC is under the overall responsibility of the High Representative of the Union for Foreign Affairs and Security Policy. FROM WHEN DOES THE DECISION APPLY? It has applied since 19 October 2020. Council Decision (CFSP) 2020/1515 repeals Council Decision (CFSP) 2016/2382. BACKGROUND For further information, see: European Security and Defence College (European Commission). MAIN DOCUMENT Council Decision (CFSP) 2020/1515 of 19 October 2020 establishing a European Security and Defence College, and repealing Decision (CFSP) 2016/2382 (OJ L 348, 20.10.2020, pp. 1\u201314). Successive amendments to Decision (CFSP) 2020/1515 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, pp. 1\u2013131). Consolidated version of the Treaty on European Union \u2014 Title V \u2014 General Provisions on the Union\u2019s External Action and Specific Provisions on the Common Foreign and Security Policy \u2014 Chapter 2 \u2014 Specific Provisions on the common foreign and security policy \u2014 Section 1 \u2014 Common provisions \u2014 Article 28 (ex Article 14 TEU) (OJ C 202, 7.6.2016, p. 32). Consolidated version of the Treaty on European Union \u2014 Title V \u2014 General Provisions on the Union\u2019s External Action and Specific Provisions on the Common Foreign and Security Policy \u2014 Chapter 2 \u2014 Specific Provisions on the common foreign and security policy \u2014 Section 2 \u2014 Provisions on the common security and defence policy \u2014 Article 42 (ex Article 17 TEU) (OJ C 202, 7.6.2016, pp. 38\u201339). Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, pp. 53\u2013114). Regulation (EU) 2015/2219 of the European Parliament and of the Council of 25 November 2015 on the European Union Agency for Law Enforcement Training (CEPOL) and replacing and repealing Council Decision 2005/681/JHA (OJ L 319, 4.12.2015, pp. 1\u201320). Council Decision (CFSP) 2015/1835 of 12 October 2015 defining the statute, seat and operational rules of the European Defence Agency (OJ L 266, 13.10.2015, pp. 55\u201374). See consolidated version. Council Decision 2014/75/CFSP of 10 February 2014 on the European Union Institute for Security Studies (OJ L 41, 12.2.2014, pp. 13\u201317). last update 08.12.2021"}
{"article": "5.6.2020 EN Official Journal of the European Union L 177/32 REGULATION (EU) 2020/741 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 May 2020 on minimum requirements for water reuse (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The water resources of the Union are increasingly coming under pressure, leading to water scarcity and a deterioration in water quality. In particular, climate change, unpredictable weather patterns and drought are contributing significantly to the strain on the availability of freshwater, arising from urban development and agriculture. (2) The Union\u2019s ability to respond to the increasing pressures on water resources could be improved by wider reuse of treated waste water, limiting extraction from surface water bodies and groundwater bodies, reducing the impact of discharge of treated waste water into water bodies, and promoting water savings through multiple uses for urban waste water, while ensuring a high level of environmental protection. Directive 2000/60/EC of the European Parliament and of the Council (4) mentions water reuse, in combination with the promotion of the use of water-efficient technologies in industry and water-saving irrigation techniques, as one of the supplementary measures Member States may choose to apply to achieve that Directive\u2019s objectives of good qualitative and quantitative water status for surface water bodies and groundwater bodies. Council Directive 91/271/EEC (5) requires that treated waste water be reused whenever appropriate. (3) The communication of the Commission of 14 November 2012\u2018A Blueprint to Safeguard Europe\u2019s Water Resources\u2019 points to the need to create an instrument to regulate standards at Union level for water reuse, in order to remove the obstacles to a widespread use of such an alternative water supply option, namely one that can help to reduce water scarcity and lessen the vulnerability of supply systems. (4) The communication of the Commission of 18 July 2007\u2018Addressing the challenge of water scarcity and droughts in the European Union\u2019 sets out the hierarchy of measures that Member States should consider in managing water scarcity and droughts. It states that in regions where all preventive measures have been implemented according to the water hierarchy and where demand for water still exceeds availability, additional water supply infrastructure can in some circumstances, and taking due account of the cost-benefit dimension, serve as an alternative approach to mitigate the impacts of severe drought. (5) In its resolution of 9 October 2008 on addressing the challenge of water scarcity and droughts in the European Union (6), the European Parliament recalls that a demand-side approach should be preferred when managing water resources, but considers that the Union should adopt a holistic approach when managing water resources, combining measures of demand management, measures to optimise existing resources within the water cycle and measures to create new resources, and that the approach needs to integrate environmental, social and economic considerations. (6) In its communication of 2 December 2015\u2018Closing the loop \u2013 An EU action plan for the Circular Economy\u2019, the Commission committed to taking a series of actions to promote the reuse of treated waste water, including the development of a legislative proposal on minimum requirements for water reuse. The Commission should update its action plan and keep water resources as a priority area in which to intervene. (7) The purpose of this Regulation is to facilitate the uptake of water reuse whenever it is appropriate and cost-efficient, thereby creating an enabling framework for those Member States who wish or need to practise water reuse. Water reuse is a promising option for many Member States, but currently only a small number of them practice water reuse and have adopted national legislation or standards in that regard. This Regulation should be flexible enough to allow the continuation of the practice of water reuse and at the same time to ensure that it is possible for other Member States to apply those rules when they decide to introduce this practice at a later stage. Any decision not to practise water reuse should be duly justified based on the criteria laid down in this Regulation and reviewed regularly. (8) Directive 2000/60/EC provides Member States with the necessary flexibility to include supplementary measures in the programmes of measures that they adopt to support their efforts to achieve the water quality objectives established by that Directive. The non-exclusive list of supplementary measures provided for in Part B of Annex VI to Directive 2000/60/EC contains, among others, water reuse measures. In this context and in line with a hierarchy of measures that could be considered by the Member States in managing water scarcity and droughts and that encourages measures ranging from water saving to water pricing policy and alternative solutions, and taking due account of the cost-benefit dimension, the minimum requirements for water reuse, as established by this Regulation, should be applicable whenever treated urban waste water from urban waste water treatment plants is reused, in accordance with Directive 91/271/EEC, for agricultural irrigation. (9) Reuse of properly treated waste water, for example from urban waste water treatment plants, is considered to have a lower environmental impact than other alternative water supply methods, such as water transfers or desalination. However, such water reuse, which could reduce water wastage and save water, is practised only to a limited extent in the Union. This appears to be partly due to the significant cost of waste water reuse systems and the lack of common Union environmental and health standards for water reuse, and, as regards, in particular, agricultural products, due to the potential health and environmental risks and potential obstacles to the free movement of such products which have been irrigated with reclaimed water. (10) Health standards in relation to food hygiene for agricultural products irrigated with reclaimed water can be achieved only if quality requirements for reclaimed water intended for agricultural irrigation do not differ significantly between the Member States. Harmonisation of requirements would also contribute to the efficient functioning of the internal market in relation to such products. It is therefore appropriate to introduce minimum levels of harmonisation by setting minimum requirements for water quality and monitoring. Those minimum requirements should consist of minimum parameters for reclaimed water that are based on the technical reports of the Commission\u2019s Joint Research Centre and reflect international standards on water reuse, and other stricter or additional quality requirements imposed, if necessary, by competent authorities together with any relevant preventive measures. (11) Water reuse for agricultural irrigation can also contribute to the promotion of the circular economy by recovering nutrients from the reclaimed water and applying them to crops, by means of fertigation techniques. Thus, water reuse could potentially reduce the need for supplemental applications of mineral fertiliser. End-users should be informed about the nutrient content of reclaimed water. (12) Water reuse could contribute to the recovery of the nutrients contained in treated urban waste water, and the use of reclaimed water for irrigation purposes in agriculture or forestry could be a way of restoring nutrients, such as nitrogen, phosphorus and potassium, to natural biogeochemical cycles. (13) The high investment needed to upgrade urban waste water treatment plants and the lack of financial incentives for practising water reuse in agriculture have been identified as being among the reasons for the low uptake of water reuse in the Union. It should be possible to address those issues by promoting innovative schemes and economic incentives to appropriately take account of the costs and the socioeconomic and environmental benefits of water reuse. (14) Compliance with minimum requirements for water reuse should be consistent with Union water policy and contribute to the achievement of the Sustainable Development Goals of the United Nations 2030 Agenda for Sustainable Development, in particular Goal 6, to ensure the availability and sustainable management of water and sanitation for all, as well as a substantial increase in recycling of water and safe water reuse globally with a view to contributing to achieving United Nations Sustainable Development Goal 12 on sustainable consumption and production. Furthermore, this Regulation should seek to ensure the application of Article 37 of the Charter of Fundamental Rights of the European Union on environmental protection. (15) In some cases, reclamation facility operators still transport and store reclaimed water beyond the outlet of the reclamation facility, prior to delivering it to the next actors in the chain, such as the reclaimed water distribution operator, the reclaimed water storage operator or the end-user. It is necessary to define the point of compliance, to clarify where the responsibility of the reclamation facility operator ends and where the responsibility of the next actor in the chain starts. (16) Risk management should comprise the identification and management of risks in a proactive way, and should incorporate the concept of producing reclaimed water of a specific quality required for particular uses. Risk assessment should be based on key elements of risk management and should identify any additional water quality requirements necessary to ensure sufficient protection of the environment and of human and animal health. For that purpose, water reuse risk management plans should ensure that reclaimed water is safely used and managed and that there are no risks to the environment or to human or animal health. In order to develop such risk management plans, existing international guidance or standards, such as ISO 20426:2018 Guidelines for health risk assessment and management for non-potable water reuse, ISO 16075:2015 Guidelines for treated waste water use for irrigation projects, or World Health Organisation (WHO) guidelines could be used. (17) The quality requirements for water intended for human consumption are laid down in Council Directive 98/83/EC (7). Member States should take appropriate measures to ensure that water reuse activities do not lead to a deterioration in the quality of water intended for human consumption. For that reason, the water reuse risk management plan should pay special attention to the protection of water bodies used for the abstraction of water intended for human consumption and relevant safeguard zones. (18) Cooperation and interaction between the various parties involved in the water reclamation process should be a precondition for setting up reclamation treatment procedures in accordance with the requirements for specific uses, and in order to be able to plan the supply of reclaimed water in line with demand from end-users. (19) In order to effectively protect the environment and human and animal health, reclamation facility operators should be primarily responsible for the quality of reclaimed water at the point of compliance. For the purposes of compliance with the minimum requirements laid down under this Regulation and with any additional conditions set by the competent authority, reclamation facility operators should monitor the quality of reclaimed water. It is therefore appropriate to establish the minimum requirements for monitoring, consisting of the frequencies of the routine monitoring and the timing and performance targets for validation monitoring. Certain requirements for routine monitoring are provided for in Directive 91/271/EEC. (20) This Regulation should cover reclaimed water which is obtained from waste water that has been collected in collecting systems, that has been treated in urban waste water treatment plants in accordance with Directive 91/271/EEC and that undergoes further treatment, either in the urban waste water treatment plant or in a reclamation facility, in order to meet the parameters set out in Annex I to this Regulation. In accordance with Directive 91/271/EEC, agglomerations of less than 2 000 population equivalent (p.e.) do not have to be provided with a collecting system. However, urban waste water from agglomerations of less than 2 000 p.e. that enters a collecting system should be subject to appropriate treatment before being discharged into fresh water or estuaries, in accordance with Directive 91/271/EEC. In that context, waste water from agglomerations of less than 2 000 p.e. should fall under the scope of this Regulation only when it enters a collecting system and is subject to treatment in an urban waste water treatment plant. Similarly, this Regulation should not concern biodegradable industrial waste water from plants belonging to the industrial sectors listed in Annex III to Directive 91/271/EEC, unless the waste water from those plants enters a collecting system and is subject to treatment in an urban waste water treatment plant. (21) The reuse of treated urban waste water for agricultural irrigation is a market-driven action, based on the demands and needs of the agricultural sector, in particular in certain Member States that face water resource shortages. The reclamation facility operators and the end-users should cooperate to ensure that reclaimed water produced in accordance with the minimum quality requirements established by this Regulation meets the needs of the end-users regarding crop categories. In cases where the quality classes of the water produced by the reclamation facility operators are not compatible with the crop category and irrigation method already in place in the area served, for example in a collective supply system, water quality requirements could be met by using, at a subsequent stage, several water treatment options alone or in combination with non-treatment options for the reclaimed water, in line with the multi-barrier approach. (22) In order to ensure optimal reuse of urban waste water resources, end-users should receive training to ensure that they use water of the appropriate reclaimed water quality class. Where the destination of a specific type of crop is unknown or where it has multiple destinations, reclaimed water of the highest quality class should be used, unless appropriate barriers are applied which enable the required quality to be achieved. (23) It is necessary to ensure that the use of reclaimed water is safe, thereby encouraging water reuse at Union level and enhancing public confidence in it. Production and supply of reclaimed water for agricultural irrigation should therefore only be permitted on the basis of a permit, granted by competent authorities of Member States. In order to ensure a harmonised approach at Union level, traceability of reclaimed water and transparency, the substantive rules for such permits should be laid down at Union level. However, the details of the procedures for granting permits, such as the designation of the competent authorities and deadlines, should be determined by Member States. Member States should be able to apply existing procedures for granting permits, which should be adapted to take account of the requirements introduced by this Regulation. When designating the parties responsible for the drawing up of the water reuse risk management plan and the competent authority for the granting of the permit for production and supply of reclaimed water, Member States should ensure that there is no conflict of interests. (24) If a reclaimed water distribution operator and a reclaimed water storage operator are needed, it should be possible to require such operators to have a permit. If all requirements for the permit are met, the competent authority in the Member State should grant a permit containing all the necessary conditions and measures established in the water reuse risk management plan. (25) For the purposes of this Regulation, it should be possible for treatment operations and urban waste water reclamation operations to take place in the same physical location, using the same facility, or different, separate facilities. In addition, it should be possible for the same actor to be both treatment plant operator and reclamation facility operator. (26) Competent authorities should verify compliance of reclaimed water with the conditions set out in the relevant permit. In cases of non-compliance, those authorities should require the responsible parties to take the necessary measures to ensure that the reclaimed water is in compliance. Supply of the reclaimed water should be suspended where non-compliance causes a significant risk to the environment or to human or animal health. (27) The provisions of this Regulation are intended to be complementary to the requirements of other Union legislation, in particular with regard to possible health and environmental risks. In order to ensure a holistic approach to addressing possible risks to the environment and to human and animal health, the reclamation facility operators and competent authorities should take into account the requirements laid down in other relevant Union legislation, in particular Council Directives 86/278/EEC (8) and 91/676/EEC (9), Directives 91/271/EEC, 98/83/EC and 2000/60/EC, Regulations (EC) No 178/2002 (10), (EC) No 852/2004 (11), (EC) No 183/2005 (12), (EC) No 396/2005 (13) and (EC) No 1069/2009 (14) of the European Parliament and of the Council, Directives 2006/7/EC (15), 2006/118/EC (16), 2008/105/EC (17) and 2011/92/EU (18) of the European Parliament and of the Council, and Commission Regulations (EC) No 2073/2005 (19), (EC) No 1881/2006 (20) and (EU) No 142/2011 (21). (28) Regulation (EC) No 852/2004 lays down general rules for food business operators and covers the production, processing, distribution and placing on the market of food intended for human consumption. That Regulation addresses the health quality of food and one of its main principles is that the primary responsibility for food safety is borne by the food business operator. That Regulation is also supported by detailed guidance. In this regard, the Commission notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene is of particular relevance. The minimum requirements for reclaimed water laid down in this Regulation do not preclude food business operators from obtaining the water quality required to comply with Regulation (EC) No 852/2004 using, at a subsequent stage, several water treatment options alone or in combination with non-treatment options. (29) There is great potential for the recycling and reuse of treated waste water. With a view to promoting and encouraging water reuse, the indication of specific uses within this Regulation should not preclude Member States from allowing the use of reclaimed water for other purposes, including industrial, amenity-related and environmental purposes, as considered necessary in the light of national circumstances and needs, provided a high level of protection of the environment and of human and animal health is ensured. (30) Competent authorities should cooperate with other relevant authorities, through the exchange of information, in order to ensure compliance with relevant Union and national requirements. (31) In order to increase confidence in water reuse, information should be provided to the public. Making available clear, comprehensive and updated information on water reuse would allow for increased transparency and traceability and could also be of particular use to other relevant authorities for whom the specific water reuse has implications. In order to encourage water reuse and with a view to making stakeholders aware of the benefits of water reuse and thereby promoting acceptance, Member States should ensure that information and awareness-raising campaigns, adapted to the scale of water reuse, are developed. (32) End-user education and training are of primary importance as components of implementing and maintaining preventive measures. Specific human exposure preventive measures should be considered in the water reuse risk management plan, such as use of personal protective equipment, handwashing and personal hygiene. (33) Directive 2003/4/EC of the European Parliament and of the Council (22) aims to guarantee the right of access to environmental information in the Member States in line with the Convention on access to information, public participation in decision-making and access to justice in environmental matters (23) (the Aarhus Convention). Directive 2003/4/EC lays down extensive obligations related both to making environmental information available upon request and actively disseminating such information. Directive 2007/2/EC of the European Parliament and of the Council (24) covers the sharing of spatial information, including data sets on different environmental topics. It is important that provisions of this Regulation related to access to information and data-sharing arrangements complement those Directives and do not create a separate legal regime. Therefore, the provisions of this Regulation on information to the public and on information about monitoring of implementation should be without prejudice to Directives 2003/4/EC and 2007/2/EC. (34) Data provided by Member States are essential to enable the Commission to monitor and assess this Regulation in relation to the objectives it pursues. (35) Pursuant to paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (25), the Commission should carry out an evaluation of this Regulation. The evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and Union value added and should provide the basis for impact assessments of possible further measures. The evaluation should take into account scientific progress, in particular as regards the potential impact of substances of emerging concern. (36) The minimum requirements for the safe reuse of treated urban waste water reflect available scientific knowledge and internationally recognised water reuse standards and practices and guarantee that such water can be safely used for agricultural irrigation, thereby ensuring a high level of protection of the environment and of human and animal health. In light of the results of the evaluation of this Regulation or whenever new scientific developments and technical progress so require, the Commission should be able to examine the need to review the minimum requirements set out in Section 2 of Annex I and, where appropriate, should submit a legislative proposal to amend this Regulation. (37) In order to adapt the key elements of risk management to technical and scientific progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the key elements of risk management provided for in this Regulation. Moreover, in order to ensure a high level of protection of the environment and of human and animal health, the Commission should also be able to adopt delegated acts supplementing the key elements of risk management provided for in this Regulation by laying down technical specifications. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (38) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission for the adoption of detailed rules regarding the format and presentation of the information relating to monitoring of the implementation of this Regulation to be provided by the Member States and regarding the format and presentation of the Union-wide overview drawn up by the European Environment Agency. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (26). (39) The aim of this Regulation is, inter alia, to protect the environment and human and animal health. As the Court of Justice has held on numerous occasions, it would be incompatible with the binding effect which the third paragraph of Article 288 of the Treaty on the Functioning of the European Union ascribes to a Directive, to exclude, in principle, the possibility of an obligation imposed by a Directive from being relied on by persons concerned. That consideration also applies in respect of a Regulation which has as its objective to guarantee that reclaimed water is safe for agricultural irrigation. (40) Member States should lay down the rules on penalties applicable to infringements of this Regulation and should take all measures necessary to ensure that they are implemented. The penalties should be effective, proportionate and dissuasive. (41) Since the objectives of this Regulation, namely the protection of the environment and of human and animal health, cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (42) It is necessary to provide for sufficient time for Member States to set up the administrative infrastructure necessary for the application of this Regulation as well as for operators to prepare for the application of the new rules. (43) With a view to developing and promoting the reuse of properly treated waste water as much as possible and in order to bring about a significant improvement in the reliability of properly treated waste water and in viable use methods, the Union should support research and development in this area through the Horizon Europe programme. (44) This Regulation seeks to encourage the sustainable use of water. With that aim in view, the Commission should undertake to use Union programmes, including the LIFE programme, to support local initiatives involving the reuse of properly treated waste water, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and purpose 1. This Regulation lays down minimum requirements for water quality and monitoring and provisions on risk management, for the safe use of reclaimed water in the context of integrated water management. 2. The purpose of this Regulation is to guarantee that reclaimed water is safe for agricultural irrigation, thereby ensuring a high level of protection of the environment and of human and animal health, promoting the circular economy, supporting adaptation to climate change, and contributing to the objectives of Directive 2000/60/EC by addressing water scarcity and the resulting pressure on water resources, in a coordinated way throughout the Union, thus also contributing to the efficient functioning of the internal market. Article 2 Scope 1. This Regulation applies whenever treated urban waste water is reused, in accordance with Article 12(1) of Directive 91/271/EEC, for agricultural irrigation as specified in Section 1 of Annex I to this Regulation. 2. A Member State may decide that it is not appropriate to reuse water for agricultural irrigation in one or more of its river basin districts or parts thereof, taking into account the following criteria: (a) the geographic and climatic conditions of the district or parts thereof; (b) the pressures on and the status of other water resources, including the quantitative status of groundwater bodies as referred to in Directive 2000/60/EC; (c) the pressures on and the status of the surface water bodies in which treated urban waste water is discharged; (d) the environmental and resource costs of reclaimed water and of other water resources. Any decision taken pursuant to the first subparagraph shall be duly justified on the basis of the criteria referred to in that subparagraph and submitted to the Commission. It shall be reviewed as necessary, in particular taking into account climate change projections and national climate change adaptation strategies, and at least every six years taking into account river basin management plans established pursuant to Directive 2000/60/EC. 3. By way of derogation from paragraph 1, research or pilot projects in relation to reclamation facilities may be exempted from this Regulation where the competent authority establishes that the following criteria are met: (a) the research or pilot project will not be carried out within a water body used for the abstraction of water intended for human consumption or a relevant safeguard zone designated pursuant to Directive 2000/60/EC; (b) the research or pilot project will be subject to appropriate monitoring. Any exemption pursuant to this paragraph shall be limited to a maximum period of five years. Crops resulting from a research or pilot project exempted pursuant to this paragraph shall not be placed on the market. 4. This Regulation applies without prejudice to Regulation (EC) No 852/2004 and does not preclude food business operators from obtaining the water quality required to comply with that Regulation by using, at a subsequent stage, several water treatment options alone or in combination with non-treatment options, or from using alternative water sources for agricultural irrigation. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018competent authority\u2019 means an authority or a body designated by a Member State to carry out its obligations under this Regulation regarding the granting of permits for the production or supply of reclaimed water, regarding exemptions for research or pilot projects and regarding compliance checks; (2) \u2018end-user\u2019 means a natural or legal person, whether a public or private entity, that uses reclaimed water for agricultural irrigation; (3) \u2018urban waste water\u2019 means urban waste water as defined in point (1) of Article 2 of Directive 91/271/EEC; (4) \u2018reclaimed water\u2019 means urban waste water that has been treated in compliance with the requirements set out in Directive 91/271/EEC and which results from further treatment in a reclamation facility in accordance with Section 2 of Annex I to this Regulation; (5) \u2018reclamation facility\u2019 means an urban waste water treatment plant or other facility that further treats urban waste water that complies with the requirements set out in Directive 91/271/EEC in order to produce water that is fit for a use specified in Section 1 of Annex I to this Regulation; (6) \u2018reclamation facility operator\u2019 means a natural or legal person, representing a private entity or a public authority, that operates or controls a reclamation facility; (7) \u2018hazard\u2019 means a biological, chemical, physical or radiological agent that has the potential to cause harm to people, animals, crops or plants, other terrestrial biota, aquatic biota, soils or the environment in general; (8) \u2018risk\u2019 means the likelihood of identified hazards causing harm in a specified timeframe, including the severity of the consequences; (9) \u2018risk management\u2019 means systematic management that consistently ensures that water reuse is safe in a specific context; (10) \u2018preventive measure\u2019 means an appropriate action or activity that can prevent or eliminate a health or environmental risk, or that can reduce such a risk to an acceptable level; (11) \u2018point of compliance\u2019 means the point where a reclamation facility operator delivers reclaimed water to the next actor in the chain; (12) \u2018barrier\u2019 is any means, including physical or process-related steps or conditions of use, that reduces or prevents a risk of human infection by preventing contact of reclaimed water with produce to be ingested and directly exposed persons, or other means that, for example, reduces the concentration of microorganisms in the reclaimed water or prevents their survival on the produce to be ingested; (13) \u2018permit\u2019 means a written authorisation issued by a competent authority to produce or supply reclaimed water for agricultural irrigation in accordance with this Regulation; (14) \u2018responsible party\u2019 means a party carrying out a role or activity in the water reuse system, including the reclamation facility operator, the urban waste water treatment plant operator where different from the reclamation facility operator, the relevant authority other than the designated competent authority, the reclaimed water distribution operator or the reclaimed water storage operator; (15) \u2018water reuse system\u2019 means the infrastructure and other technical elements necessary for producing, supplying and using reclaimed water; it comprises all the elements from the entry point of the urban waste water treatment plant to the point where reclaimed water is used for agricultural irrigation, including distribution and storage infrastructure, where relevant. Article 4 Obligations of the reclamation facility operator and obligations regarding reclaimed water quality 1. The reclamation facility operator shall ensure that, at the point of compliance, reclaimed water intended for agricultural irrigation as specified in Section 1 of Annex I complies with the following: (a) the minimum requirements for water quality laid down in Section 2 of Annex I; (b) any additional conditions set by the competent authority in the relevant permit pursuant to points (c) and (d) of Article 6(3), as regards water quality. Beyond the point of compliance, the quality of the water shall no longer be the responsibility of the reclamation facility operator. 2. In order to ensure compliance in accordance with paragraph 1, the reclamation facility operator shall monitor water quality in accordance with the following: (a) Section 2 of Annex I; (b) any additional conditions set by the competent authority in the relevant permit pursuant to points (c) and (d) of Article 6(3), as regards monitoring. Article 5 Risk management 1. For the purpose of producing, supplying and using reclaimed water, the competent authority shall ensure that a water reuse risk management plan is established. One water reuse risk management plan may cover one or more water reuse systems. 2. The water reuse risk management plan shall be prepared by the reclamation facility operator, other responsible parties and end-users, as appropriate. The responsible parties preparing the water reuse risk management plan shall consult all other relevant responsible parties and end-users, as appropriate. 3. The water reuse risk management plan shall be based on all the key elements of risk management set out in Annex II. It shall identify the risk management responsibilities of the reclamation facility operator and other responsible parties. 4. The water reuse risk management plan shall in particular: (a) set out any necessary requirements for the reclamation facility operator, in addition to those specified in Annex I, in accordance with point (B) of Annex II to further mitigate any risks before the point of compliance; (b) identify hazards, risks and appropriate preventive and/or possible corrective measures in accordance with point (C) of Annex II; (c) identify additional barriers in the water reuse system and set out any additional requirements, which are necessary after the point of compliance to ensure that the water reuse system is safe, including conditions related to distribution, storage and use where relevant, and identify the parties responsible for meeting those requirements. 5. The Commission is empowered to adopt delegated acts in accordance with Article 13 amending this Regulation in order to adapt to technical and scientific progress the key elements of risk management set out in Annex II. The Commission is also empowered to adopt delegated acts in accordance with Article 13 supplementing this Regulation in order to lay down technical specifications of the key elements of risk management set out in Annex II. Article 6 Reclaimed water permit obligations 1. The production and supply of reclaimed water intended for agricultural irrigation as specified in Section 1 of Annex I shall be subject to a permit. 2. The responsible parties in the water reuse system, including the end-user where relevant in accordance with national law, shall submit an application for a permit or for a modification of an existing permit to the competent authority of the Member State in which the reclamation facility operates or is planned to operate. 3. The permit shall set out the obligations of the reclamation facility operator and, where relevant, of any other responsible parties. The permit shall be based on the water reuse risk management plan and shall specify, inter alia, the following: (a) the reclaimed water quality class or classes and the agricultural use for which, in accordance with Annex I, the reclaimed water is permitted, the place of use, the reclamation facilities and the estimated yearly volume of the reclaimed water to be produced; (b) conditions in relation to the minimum requirements for water quality and monitoring set out in Section 2 of Annex I; (c) any conditions in relation to additional requirements for the reclamation facility operator, set out in the water reuse risk management plan; (d) any other conditions necessary to eliminate any unacceptable risks to the environment and to human and animal health so that any risks are of an acceptable level; (e) the validity period of the permit; (f) the point of compliance. 4. For the purpose of assessing an application, the competent authority shall consult and exchange relevant information with other relevant authorities, in particular the water and health authorities if different from the competent authority, and any other party which the competent authority considers relevant. 5. The competent authority shall decide without delay whether to grant a permit. Where, due to the complexity of an application, the competent authority needs more than 12 months from the receipt of a complete application to decide whether to grant a permit, it shall communicate the expected date of its decision to the applicant. 6. Permits shall be regularly reconsidered, and shall be updated where necessary, at least in the following cases: (a) there has been a substantial change in capacity; (b) equipment has been upgraded; (c) new equipment or processes have been added; or (d) there have been changes in climatic or other conditions which significantly affect the ecological status of surface water bodies. 7. Member States may require that storage, distribution and use of reclaimed water be subject to a specific permit in order to apply the additional requirements and barriers identified in the water reuse risk management plan as referred to in Article 5(4). Article 7 Compliance check 1. The competent authority shall verify whether there is compliance with the conditions set out in the permit. Compliance checks shall be carried out through the following means: (a) on-the-spot checks; (b) monitoring data obtained in particular pursuant to this Regulation; (c) any other adequate means. 2. In the event of non-compliance with the conditions set out in the permit, the competent authority shall require the reclamation facility operator and, where relevant, the other responsible parties to take any necessary measures to restore compliance without delay and immediately inform the end-users affected. 3. Where non-compliance with the conditions set out in the permit represents a significant risk to the environment or to human or animal health, the reclamation facility operator or any other responsible parties shall immediately suspend supply of the reclaimed water until the competent authority determines that compliance has been restored, following procedures defined in the water reuse risk management plan, in accordance with point (a) of Section 2 of Annex I. 4. If an incident affecting compliance with the conditions set out in the permit occurs, the reclamation facility operator or any other responsible parties shall immediately inform the competent authority and other parties which could potentially be affected, and communicate to the competent authority the information necessary for assessing the impact of such an incident. 5. The competent authority shall regularly verify compliance by the responsible parties with the measures and tasks set out in the water reuse risk management plan. Article 8 Cooperation between Member States 1. Where water reuse is of cross-border relevance, Member States shall designate a contact point for the purposes of cooperation with other Member States\u2019 contact points and competent authorities, as appropriate, or shall use existing structures stemming from international agreements. The role of contact points or existing structures shall be to: (a) receive and transmit requests for assistance; (b) provide assistance upon request; and (c) coordinate communication between competent authorities. Before granting a permit, competent authorities shall exchange information on the conditions set out in Article 6(3) with the contact point in the Member State in which reclaimed water is intended to be used. 2. Member States shall respond to requests for assistance without undue delay. Article 9 Information and awareness-raising Savings of water resources as a result of water reuse shall be the subject of general awareness-raising campaigns in Member States where reclaimed water is used for agricultural irrigation. Such campaigns may include the promotion of the benefits of safe water reuse. Those Member States may also set up information campaigns for end-users to ensure the optimal and safe use of reclaimed water, thereby ensuring a high level of protection of the environment and of human and animal health. Member States may adapt such information and awareness-raising campaigns to the scale of water reuse. Article 10 Information to the public 1. Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States in which reclaimed water is used for agricultural irrigation as specified in Section 1 of Annex I to this Regulation shall ensure that adequate and up-to-date information on water reuse is available to the public, online or by other means. That information shall include the following: (a) the quantity and the quality of the reclaimed water supplied in accordance with this Regulation; (b) the percentage of the reclaimed water in the Member State supplied in accordance with this Regulation compared to the total amount of treated urban waste water, where such data are available; (c) the permits granted or modified in accordance with this Regulation, including the conditions set by competent authorities in accordance with Article 6(3) of this Regulation; (d) the results of any compliance checks carried out in accordance with Article 7(1) of this Regulation; (e) the contact points designated in accordance with Article 8(1) of this Regulation. 2. The information referred to in paragraph 1 shall be updated every two years. 3. Member States shall ensure that any decision taken in accordance with Article 2(2) is made available to the public, online or by other means. Article 11 Information relating to monitoring of implementation 1. Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States in which reclaimed water is used for agricultural irrigation as specified in Section 1 of Annex I to this Regulation, assisted by the European Environment Agency, shall: (a) set up and publish by 26 June 2026, and update every six years thereafter, a data set containing information on the outcome of the compliance check performed in accordance with Article 7(1) of this Regulation and other information to be made available to the public, online or by other means, in accordance with Article 10 of this Regulation; (b) set up, publish and update annually thereafter, a data set containing information on cases of non-compliance with the conditions set out in the permit, which has been collected in accordance with Article 7(1) of this Regulation, and information on the measures taken in accordance with Article 7(2) and (3) of this Regulation. 2. Member States shall ensure that the Commission, the European Environment Agency and the European Centre for Disease Prevention and Control have access to the data sets referred to in paragraph 1. 3. On the basis of the data sets referred to in paragraph 1, the European Environment Agency, in consultation with Member States, shall draw up, publish and update, on a regular basis or following a request from the Commission, a Union-wide overview. That overview shall include, as appropriate, indicators for outputs, results and impacts of this Regulation, maps, and Member State reports. 4. The Commission may, by means of implementing acts, lay down detailed rules regarding the format and presentation of the information to be provided in accordance with paragraph 1 as well as detailed rules regarding the format and presentation of the Union-wide overview referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14. 5. By 26 June 2022, the Commission shall, in consultation with Member States, establish guidelines to support the application of this Regulation. Article 12 Evaluation and review 1. The Commission shall, by 26 June 2028, carry out an evaluation of this Regulation. The evaluation shall be based on at least the following: (a) the experience gathered from the implementation of this Regulation; (b) the data sets set up by Member States in accordance with Article 11(1) and the Union-wide overview drawn up by the European Environment Agency in accordance with Article 11(3); (c) relevant scientific, analytical and epidemiological data; (d) technical and scientific knowledge; (e) WHO recommendations, where available, or other international guidance or ISO standards. 2. In carrying out the evaluation, the Commission shall pay particular attention to the following aspects: (a) the minimum requirements set out in Annex I; (b) the key elements of risk management set out in Annex II; (c) the additional requirements set by competent authorities pursuant to points (c) and (d) of Article 6(3); (d) the impact of water reuse on the environment and on human and animal health, including the impact of substances of emerging concern. 3. As part of the evaluation, the Commission shall assess the feasibility of: (a) extending the scope of this Regulation to reclaimed water intended for further specific uses, including reuse for industrial purposes; (b) expanding the requirements of this Regulation to cover the indirect use of treated waste water. 4. Based on the results of the evaluation or whenever new technical and scientific knowledge so requires, the Commission may examine the need to review the minimum requirements set out in Section 2 of Annex I. 5. Where appropriate, the Commission shall submit a legislative proposal to amend this Regulation. Article 13 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 5(5) shall be conferred on the Commission for a period of five years from 25 June 2020. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 5(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 5(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 14 Committee procedure 1. The Commission shall be assisted by the Committee established by Directive 2000/60/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 15 Penalties Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 26 June 2024, notify the Commission of those rules and of those measures and shall notify it of any subsequent amendment affecting them. Article 16 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 June 2023. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 25 May 2020. For the European Parliament The President D. M. SASSOLI For the Council The President A. METELKO-ZGOMBI\u0106 (1) OJ C 110, 22.3.2019, p. 94. (2) OJ C 86, 7.3.2019, p. 353. (3) Position of the European Parliament of 12 February 2019 (not yet published in the Official Journal) and position of the Council at first reading of 7 April 2020 (OJ C 147, 4.5.2020, p. 1). Position of the European Parliament of 13 May 2020 (not yet published in the Official Journal). (4) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (5) Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (OJ L 135, 30.5.1991, p. 40). (6) OJ C 9 E, 15.1.2010, p. 33. (7) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32). (8) Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.1986, p. 6). (9) Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1). (10) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (11) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1). (12) Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1). (13) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). (14) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1). (15) Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality and repealing Directive 76/160/EEC (OJ L 64, 4.3.2006, p. 37). (16) Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19). (17) Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84). (18) Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1). (19) Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1). (20) Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5). (21) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1). (22) Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). (23) OJ L 124, 17.5.2005, p. 4. (24) Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1). (25) OJ L 123, 12.5.2016, p. 1. (26) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). ANNEX I USES AND MINIMUM REQUIREMENTS Section 1 Uses of reclaimed water Agricultural irrigation Agricultural irrigation means irrigation of the following types of crops: \u2014 food crops consumed raw, meaning crops which are intended for human consumption in a raw or unprocessed state; \u2014 processed food crops, meaning crops which are intended for human consumption after a treatment process (i.e. cooked or industrially processed); \u2014 non-food crops, meaning crops which are not intended for human consumption (e.g. pastures and forage, fibre, ornamental, seed, energy and turf crops). Without prejudice to other relevant Union law in the fields of the environment and of health, Member States may use reclaimed water for further uses such as: \u2014 industrial water reuse; and \u2014 amenity-related and environmental purposes. Section 2 Minimum requirements Minimum requirements applicable to reclaimed water intended for agricultural irrigation The reclaimed water quality classes and the permitted uses and irrigation methods for each class are set out in Table 1. The minimum requirements for water quality are set out in Table 2 of point (a). The minimum frequencies and performance targets for monitoring reclaimed water are set out in Table 3 (routine monitoring) and Table 4 (validation monitoring) of point (b). Crops belonging to a given category shall be irrigated with reclaimed water of the corresponding minimum reclaimed water quality class as set out in Table 1, unless appropriate additional barriers as referred to in point (c) of Article 5(4) are used, which result in achieving the quality requirements set out in Table 2 of point (a). Such additional barriers may be based on the indicative list of preventive measures referred to in point 7 of Annex II or in any other equivalent national or international standards, e.g. the standard ISO 16075-2. Table 1 \u2013 Classes of reclaimed water quality and permitted agricultural use and irrigation method Minimum reclaimed water quality class Crop category (*1) Irrigation method A All food crops consumed raw where the edible part is in direct contact with reclaimed water and root crops consumed raw All irrigation methods B Food crops consumed raw where the edible part is produced above ground and is not in direct contact with reclaimed water, processed food crops and non-food crops including crops used to feed milk- or meat-producing animals All irrigation methods C Food crops consumed raw where the edible part is produced above ground and is not in direct contact with reclaimed water, processed food crops and non-food crops including crops used to feed milk- or meat-producing animals Drip irrigation (*2) or other irrigation method that avoids direct contact with the edible part of the crop D Industrial, energy and seeded crops All irrigation methods (*3) (a) Minimum requirements for water quality Table 2 \u2013 Reclaimed water quality requirements for agricultural irrigation Reclaimed water quality class Indicative technology target Quality requirements E. coli (number/100 ml) BOD5 (mg/l) TSS (mg/l) Turbidity (NTU) Other A Secondary treatment, filtration, and disinfection \u2264 10 \u2264 10 \u2264 10 \u2264 5 Legionella spp.: < 1 000 cfu/l where there is a risk of aerosolisation Intestinal nematodes (helminth eggs): \u2264 1 egg/l for irrigation of pastures or forage B Secondary treatment, and disinfection \u2264 100 In accordance with Directive 91/271/EEC (Annex I, Table 1) In accordance with Directive 91/271/EEC (Annex I, Table 1) - C Secondary treatment, and disinfection \u2264 1 000 - D Secondary treatment, and disinfection \u2264 10 000 - Reclaimed water shall be considered to be in compliance with the requirements set out in Table 2 where the measurements for that reclaimed water meet all of the following criteria: \u2014 the indicated values for E. coli, Legionella spp. and intestinal nematodes are met in 90 % or more of the samples; none of the values of the samples exceed the maximum deviation limit of 1 log unit from the indicated value for E. coli and Legionella spp. and 100 % of the indicated value for intestinal nematodes; \u2014 the indicated values for BOD5, TSS, and turbidity in Class A are met in 90 % or more of the samples; none of the values of the samples exceed the maximum deviation limit of 100 % of the indicated value. (b) Minimum requirements for monitoring Reclamation facility operators shall perform routine monitoring to verify that the reclaimed water is in compliance with the minimum water quality requirements set out in point (a). The routine monitoring shall be included in the verification procedures of the water reuse system. The samples to be used to verify compliance with the microbiological parameters at the point of compliance shall be taken in accordance with standard EN ISO 19458 or with any other national or international standards that ensure equivalent quality. Table 3 \u2013 Minimum frequencies for routine monitoring of reclaimed water for agricultural irrigation Minimum monitoring frequencies Reclaimed water quality class E. coli BOD5 TSS Turbidity Legionella spp. (when applicable) Intestinal nematodes (when applicable) A Once a week Once a week Once a week Continuous Twice a month Twice a month or as determined by the reclamation facility operator according to the number of eggs in waste water entering the reclamation facility B Once a week In accordance with Directive 91/271/EEC (Annex I, Section D) In accordance with Directive 91/271/EEC (Annex I, Section D) - C Twice a month - D Twice a month - Validation monitoring shall be performed before a new reclamation facility is put into operation. Reclamation facilities that are already in operation and that meet the reclaimed water quality requirements set out in Table 2 of point (a) on 25 June 2020 shall be exempted from that validation monitoring obligation. However, validation monitoring shall be performed in all cases where equipment is upgraded, and when new equipment or processes are added. Validation monitoring shall be performed for the reclaimed water quality class with the most stringent requirements, Class A, to assess whether the performance targets (log10 reduction) are complied with. Validation monitoring shall entail the monitoring of the indicator microorganisms associated with each group of pathogens, namely bacteria, viruses and protozoa. The indicator microorganisms selected are E. coli for pathogenic bacteria, F-specific coliphages, somatic coliphages or coliphages for pathogenic viruses, and Clostridium perfringens spores or spore-forming sulfate-reducing bacteria for protozoa. Performance targets (log10 reduction) for the validation monitoring for the selected indicator microorganisms are set out in Table 4 and shall be met at the point of compliance, considering the concentrations of the raw waste water entering the urban waste water treatment plant. At least 90 % of validation samples shall reach or exceed the performance targets. If a biological indicator is not present in sufficient quantity in raw waste water to achieve the log10 reduction, the absence of such biological indicator in reclaimed water shall mean that the validation requirements are complied with. The compliance with the performance target may be established by analytical control, by addition of the performance granted to individual treatment steps based on scientific evidence for standard well-established processes, such as published data of testing reports or case studies, or tested in a laboratory under controlled conditions for innovative treatment. Table 4 \u2013 Validation monitoring of reclaimed water for agricultural irrigation Reclaimed water quality class Indicator microorganisms (*4) Performance targets for the treatment chain (log10 reduction) A E. coli \u2265 5,0 Total coliphages/F-specific coliphages/somatic coliphages/coliphages (*5) \u2265 6,0 Clostridium perfringens spores/spore-forming sulfate-reducing bacteria (*6) \u2265 4,0 (in case of Clostridium perfringens spores) \u2265 5,0 (in case of spore-forming sulfate-reducing bacteria) Methods of analysis for monitoring shall be validated and documented in accordance with EN ISO/IEC-17025 or other national or international standards that ensure an equivalent quality. (*1) If the same type of irrigated crop falls under multiple categories of Table 1, the requirements of the most stringent category shall apply. (*2) Drip irrigation (also called trickle irrigation) is a micro-irrigation system capable of delivering water drops or tiny streams to the plants and involves dripping water onto the soil or directly under its surface at very low rates (2\u201320 litres/hour) from a system of small-diameter plastic pipes fitted with outlets called emitters or drippers. (*3) In the case of irrigation methods which imitate rain, special attention should be paid to the protection of the health of workers or bystanders. For this purpose, appropriate preventive measures shall be applied. (*4) The reference pathogens Campylobacter, Rotavirus and Cryptosporidium may also be used for validation monitoring purposes instead of the proposed indicator microorganisms. The following log10 reduction performance targets shall then apply: Campylobacter (\u2265 5,0), Rotavirus (\u2265 6,0) and Cryptosporidium (\u2265 5,0). (*5) Total coliphages is selected as the most appropriate viral indicator. However, if analysis of total coliphages is not feasible, at least one of them (F-specific or somatic coliphages) shall be analysed. (*6) Clostridium perfringens spores is selected as the most appropriate protozoa indicator. However, spore-forming sulfate-reducing bacteria are an alternative if the concentration of Clostridium perfringens spores does not make it possible to validate the requested log10 removal. ANNEX II (A) Key elements of risk management Risk management shall comprise identifying and managing risks in a proactive way to ensure that reclaimed water is safely used and managed and that there is no risk to the environment or to human or animal health. For those purposes, a water reuse risk management plan shall be established on the basis of the following elements: 1. Description of the entire water reuse system, from the entry of waste water into the urban waste water treatment plant to the point of use, including the sources of waste water, the treatment steps and the technologies used at the reclamation facility, the supply, distribution and storage infrastructure, the intended use, the place and period of use (e.g. temporary or ad-hoc use), the irrigation method, the crop type, other water sources if a mix is intended to be used and the volume of reclaimed water to be supplied. 2. Identification of all parties involved in the water reuse system and a clear description of their roles and responsibilities. 3. Identification of potential hazards, in particular the presence of pollutants and pathogens, and the potential for hazardous events such as treatment failures or accidental leakages or contamination of the water reuse system. 4. Identification of the environments and populations at risk, and the exposure routes to the identified potential hazards, taking into account specific environmental factors, such as local hydrogeology, topology, soil type and ecology, and factors related to the type of crops and farming and irrigation practices. Consideration of possible irreversible or long-term negative environmental and health effects of the water reclamation operation, supported by scientific evidence. 5. Assessment of risks to the environment and to human and animal health, taking into account the nature of the identified potential hazards, the duration of the intended uses, the identified environments and populations at risk of exposure to those hazards and the severity of possible effects of the hazards considering the precautionary principle, as well as all relevant Union and national legislation, guidance documents and minimum requirements in relation to food and feed and worker safety. The risk assessment could be based on a review of available scientific studies and data. The risk assessment shall consist of the following elements: (a) an assessment of risks to the environment, including all of the following: (i) confirmation of the nature of the hazards, including, where relevant, the predicted no-effect level; (ii) assessment of the potential range of exposure; (iii) characterisation of the risks; (b) an assessment of risks to human and animal health, including all of the following: (i) confirmation of the nature of the hazards, including, where relevant, the dose-response relationship; (ii) assessment of the potential range of dose or exposure; (iii) characterisation of the risks. The risk assessment may be carried out using qualitative or semi-quantitative risk assessment. Quantitative risk assessment shall be used when there are sufficient supporting data or in projects having a potential high risk for the environment or public health. The following requirements and obligations shall, as a minimum, be taken into account in the risk assessment: (a) the requirement to reduce and prevent water pollution from nitrates in accordance with Directive 91/676/EEC; (b) the obligation for protected areas for water intended for human consumption to meet the requirements of Directive 98/83/EC; (c) the requirement to meet the environmental objectives set out in Directive 2000/60/EC; (d) the requirement to prevent groundwater pollution in accordance with Directive 2006/118/EC; (e) the requirement to meet the environmental quality standards for priority substances and certain other pollutants laid down in Directive 2008/105/EC; (f) the requirement to meet the environmental quality standards for pollutants of national concern, namely river basin specific pollutants, laid down in Directive 2000/60/EC; (g) the requirement to meet the bathing water quality standards laid down in Directive 2006/7/EC; (h) the requirements concerning the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture under Directive 86/278/EEC; (i) the requirements regarding hygiene of foodstuffs as laid down in Regulation (EC) No 852/2004 and the guidance provided in the Commission notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene; (j) the requirements for feed hygiene laid down in Regulation (EC) No 183/2005; (k) the requirement to comply with the relevant microbiological criteria set out in Regulation (EC) No 2073/2005; (l) the requirements regarding maximum levels for certain contaminants in foodstuffs set out in Regulation (EC) No 1881/2006; (m) the requirements regarding maximum residue levels of pesticides in or on food and feed set out in Regulation (EC) No 396/2005; (n) the requirements regarding animal health set out in Regulations (EC) No 1069/2009 and (EU) No 142/2011. (B) Conditions relating to the additional requirements 6. Consideration of requirements for water quality and monitoring that are additional to or stricter than those specified in Section 2 of Annex I, or both, when necessary and appropriate to ensure adequate protection of the environment and of human and animal health, in particular when there is clear scientific evidence that the risk originates from reclaimed water and not from other sources. Depending on the outcome of the risk assessment referred to in point 5, such additional requirements may in particular concern: (a) heavy metals; (b) pesticides; (c) disinfection by-products; (d) pharmaceuticals; (e) other substances of emerging concern, including micro pollutants and micro plastics; (f) anti-microbial resistance. (C) Preventive measures 7. Identification of preventive measures that are already in place or that should be taken to limit risks so that all identified risks can be adequately managed. Special attention shall be paid to water bodies used for the abstraction of water intended for human consumption and relevant safeguard zones. Such preventive measures may include: (a) access control; (b) additional disinfection or pollutant removal measures; (c) specific irrigation technology mitigating the risk of aerosol formation (e.g. drip irrigation); (d) specific requirements for sprinkler irrigation (e.g. maximum wind speed, distances between sprinkler and sensitive areas); (e) specific requirements for agricultural fields (e.g. slope inclination, field water saturation and karstic areas); (f) pathogen die-off support before harvest; (g) establishment of minimum safety distances (e.g. from surface water, including sources for livestock, or activities such as aquaculture, fish farming, shellfish aquaculture, swimming and other aquatic activities); (h) signage at irrigation sites, indicating that reclaimed water is being used and is not suitable for drinking. Specific preventive measures that may be relevant are set out in Table 1. Table 1 \u2013 Specific preventive measures Reclaimed water quality class Specific preventive measures A \u2014 Pigs must not be exposed to fodder irrigated with reclaimed water unless there are sufficient data to indicate that the risks for a specific case can be managed. B \u2014 Prohibition of harvesting of wet irrigated or dropped produce. \u2014 Exclude lactating dairy cattle from pasture until pasture is dry. \u2014 Fodder has to be dried or ensiled before packaging. \u2014 Pigs must not be exposed to fodder irrigated with reclaimed water unless there are sufficient data to indicate that the risks for a specific case can be managed. C \u2014 Prohibition of harvesting of wet irrigated or dropped produce. \u2014 Exclude grazing animals from pasture for five days after last irrigation. \u2014 Fodder has to be dried or ensiled before packaging. \u2014 Pigs must not be exposed to fodder irrigated with reclaimed water unless there are sufficient data to indicate that the risks for a specific case can be managed. D \u2014 Prohibition of harvesting of wet irrigated or dropped produce. 8. Adequate quality control systems and procedures, including monitoring the reclaimed water for relevant parameters, and adequate maintenance programmes for equipment. It is recommended that the reclamation facility operator set up and maintain a quality management system certified under ISO 9001 or equivalent. 9. Environmental monitoring systems to ensure that feedback from the monitoring is provided and that all processes and procedures are appropriately validated and documented. 10. Appropriate systems to manage incidents and emergencies, including procedures to inform all relevant parties of such events in an appropriate manner, and regular updates of emergency response plan. Member States could use existing international guidance or standards, such as ISO 20426:2018 Guidelines for health risk assessment and management for non-potable water reuse, ISO 16075:2015 Guidelines for treated waste water use for irrigation projects or other equivalent standards accepted at international level, or WHO guidelines, as instruments for the systematic identification of hazards, the evaluation and the management of risks, based on a priority approach applied to the whole chain (from the treatment of urban waste water for reuse, to the distribution and the utilisation for agricultural irrigation, to the control of the effects) and on site specific risk assessment. 11. Ensure that coordination mechanisms are established amongst different actors to guarantee the safe production and use of reclaimed water.", "summary": "Minimum requirements for water reuse Minimum requirements for water reuse SUMMARY OF: Regulation (EU) 2020/741 on minimum requirements for water reuse WHAT IS THE AIM OF THE REGULATION? It sets out harmonised parameters to guarantee the safety of water reuse in agricultural irrigation, with the aim of encouraging this practice and helping to address droughts and water stress. It also aims to contribute to the UN Sustainable Development Goals, in particular Goal 6 on the availability and sustainable management of water and sanitation for all, and Goal 12 on sustainable consumption and production. KEY POINTS The regulation sets out minimum requirements for water quality and monitoring and rules on risk management, for the safe use of reclaimed water for agricultural irrigation in the context of integrated water management. It builds on 2 European Commission communications: the 2012 Blueprint to Safeguard Europe\u2019s Water Resources (see summary); and the 2015 EU action plan for the Circular Economy which committed to a series of actions to promote the use of treated waste water and to a legal proposal setting out minimum requirements for water reuse. Scope The regulation applies whenever treated urban waste water is reused, according to Article 12(1) of Directive 91/271/EEC on urban waste water, for agricultural irrigation (see summary). An EU country can decide that it is not appropriate to reuse water for agricultural irrigation in one or more of its river basin districts or parts thereof, on the basis of specific criteria: the geographic and climatic conditions of the district or parts thereof;the pressures on and the status of other water resources;the pressures on and the status of the surface water bodies in which treated urban waste water is discharged;the environmental and resource costs of reclaimed water and of other water resources. Such decision must be duly justified and regularly reviewed to take into account changing circumstances, such as climate change projections and national climate change adaptation strategies, as well as the river basins management plans drawn up in accordance with the Water Framework Directive (Directive 2000/60/EC \u2014 see summary). The regulation allows for time-limited exemptions from the rules for research or pilot projects, subject to certain conditions. Reclaimed water quality The reclamation facility operator must ensure that reclaimed water intended for agricultural irrigation complies with: the minimum requirements for water quality set out in the annex 1 of the regulation \u2014 covering microbiological elements (such as levels of E. coli bacteria) and monitoring requirements for routine and validation monitoring; any additional conditions concerning water quality set by the competent authority in the relevant permit issued. Risk management The relevant national authority must ensure that a water reuse risk management plan to produce, supply and use reclaimed water is drawn up. The water reuse risk management plan can be drafted by the reclamation facility operator, other parties in the water reuse project or the end users, as appropriate, and it must identify the risk management responsibilities of all parties in the water reuse project. It must, in particular, set out any additional water quality requirements, identify appropriate preventive and/or corrective measures and any additional barriers or measures to ensure the safety of the system. Permit obligations The production and supply of reclaimed water for agricultural irrigation requires a permit. Parties concerned must submit an application to the relevant national authority. The permits sets out the obligations for the reclamation facility operator, and, where relevant, of other parties involved in the water reuse system, which are based on the risk management plan. They must specify a number of elements including: the reclaimed water quality class or classes and the agricultural use for which the reclaimed water is permitted, the place of use, the reclamation facilities and the estimated yearly volume of the reclaimed water to be produced;conditions in relation to the minimum requirements for water quality and monitoring;conditions in relation to additional requirements for the reclamation facility operator, set out in the water reuse risk management plan;any other conditions necessary to eliminate any unacceptable risks to the environment and to human and animal health so that any risks are of an acceptable level;the validity period of the permit;the point of compliance. Permits must be regularly reviewed and updated where necessary, and at least in the case of significant changes in the treatment processes or in the site conditions. Compliance checks The competent national authority must check compliance with the conditions set out in the permit. These can be carried out by: on-the-spot checks;monitoring data obtained, in particular pursuant to this regulation;any other adequate means. The regulation also sets out the measures to be taken in case of non-compliance. The competent national authority must also regularly check compliance with risk management plans. Transparency and information sharing National contact points must be established to facilitate cross-border coordination where necessary. To ensure transparency, the regulation also sets out rules on: awareness raising;information to be provided to the public;information on the monitoring of implementation. The Commission will carry out an evaluation of the regulation by 26 June 2028. FROM WHEN DOES THE REGULATION APPLY? It applies from 26 June 2023. BACKGROUND For more information, see: Water reuse (European Commission). MAIN DOCUMENT Regulation (EU) 2020/741 of the European Parliament and of the Council of 25 May 2020 on minimum requirements for water reuse (OJ L 177, 5.6.2020, pp. 32-55) RELATED DOCUMENTS Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 Closing the loop \u2014 An EU action plan for the Circular Economy (COM(2015) 614 final, 2.12.2015) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 A Blueprint to Safeguard Europe's Water Resources (COM(2012) 673 final, 14.11.2012) Communication from the Commission to the European Parliament and the Council \u2014 Addressing the challenge of water scarcity and droughts in the European Union (COM(2007) 414 final, 18.7.2007) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, pp. 1-54). Text republished in corrigendum (OJ L 226, 25.6.2004, pp. 3-21) Successive amendments to Regulation (EC) No 852/2004 have been incorporated into the original text. This consolidated version is of documentary value only. Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, pp. 1-73) See consolidated version. Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, pp. 32-54) See consolidated version. Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, pp. 40-52) See consolidated version. last update 07.09.2020"}
{"article": "28.10.2021 EN Official Journal of the European Union L 382/1 DIRECTIVE (EU) 2021/1883 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 October 2021 on the conditions of entry and residence of third-country nationals for the purpose of highly qualified employment, and repealing Council Directive 2009/50/EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 79(2), points (a) and (b), thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Commission communication of 3 March 2010 entitled \u2018Europe 2020: A strategy for smart, sustainable and inclusive growth\u2019 sets the objectives of the Union becoming an economy based on knowledge and innovation, reducing the administrative burden on companies and better matching labour supply with demand. That communication identifies the need for a comprehensive labour migration policy and for better integration of migrants. Measures to facilitate the admission of highly qualified third-country workers have to be seen in that broader context. (2) The conclusions of the European Council of 26 and 27 June 2014 state that in order to remain an attractive destination for talents and skills, Europe must compete in the global race for talent. Strategies to maximise opportunities for legal migration should therefore be developed, including the streamlining of existing rules. (3) The Commission communication of 13 May 2015 entitled \u2018European Agenda on Migration\u2019 calls for an attractive Union-wide scheme for highly qualified third-country nationals and specifies that a review of Council Directive 2009/50/EC (4) is needed to enable the Union to more effectively attract talent and thereby to address both the demographic challenges faced by the Union and labour and skills shortages in key sectors of the Union economy. The call to review that Directive is reiterated in the Commission communication of 23 September 2020\u2018on a New Pact on Migration and Asylum\u2019, which states that the reform of the EU Blue Card \u2018must bring real EU added value in attracting skills through an effective and flexible EU-wide instrument\u2019. (4) The European Parliament, in its resolution of 12 April 2016 (5), called for an ambitious and targeted review of Directive 2009/50/EC, including of its scope. (5) It is necessary to respond to the challenges identified in the Commission\u2019s communication of 22 May 2014 on the implementation of Directive 2009/50/EC. The Union should aim to establish a more attractive and effective Union-wide scheme for highly qualified workers from third countries. The Union approach to attracting such highly qualified workers should be further harmonised and the EU Blue Card should be made the primary tool in that regard, with faster procedures, more flexible and inclusive admission criteria, and more extensive rights, including facilitated intra-EU mobility. As this would entail substantial changes to Directive 2009/50/EC, that Directive should be repealed and replaced by a new Directive. (6) A clear and transparent Union-wide admission system to attract and retain highly qualified workers from third countries and to promote the mobility of those workers should be established. This Directive should apply regardless of whether the initial purpose of residence of the third-country national is highly qualified employment or is another purpose which then changes to the purpose of highly qualified employment. It is necessary to take into account Member States\u2019 priorities, the needs of their labour markets and their reception capacities. This Directive should be without prejudice to the competence of the Member States to issue national residence permits other than EU Blue Cards for the purpose of highly qualified employment. Moreover, this Directive should not affect the possibility for an EU Blue Card holder to enjoy additional rights and benefits under national law which are compatible with this Directive. (7) Member States should ensure a level playing field between EU Blue Cards and national residence permits for the purpose of highly qualified employment, in terms of procedural and equal treatment rights, procedures and access to information. In particular, Member States should ensure that the level of procedural safeguards and rights granted to EU Blue Card holders and their family members is not lower than the level of procedural safeguards and rights enjoyed by holders of national residence permits. Member States should also ensure that applicants for an EU Blue Card are not in a less favourable position than applicants for national residence permits with regard to recognition procedures for employers, and that they are not required to pay higher fees for the handling of their application. Finally, Member States should engage in the same level of information, promotion and advertisement activities with respect to the EU Blue Card as they do for national residence permits, for example with regard to information on national websites on legal migration, information campaigns and training programmes provided to the competent migration authorities. (8) In order to reinforce and promote the EU Blue Card scheme and to attract highly qualified workers from third-countries, Member States are encouraged to strengthen advertising activities and information campaigns concerning the EU Blue Card, including, where appropriate, activities and campaigns directed at third countries. (9) In implementing this Directive, Member States are not to discriminate on the basis of sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation, as required by Council Directives 2000/43/EC (6) and 2000/78/EC (7) in particular. For the principle of non-discrimination to be effective, EU Blue Card holders should be able to seek legal redress and to lodge complaints as provided for by national law if they face any kind of discrimination, including in the labour market. (10) Having regard to the Eurostat report of 21 February 2020 entitled \u2018Hard-to-fill ICT vacancies: an increasing challenge\u2019 and its conclusions regarding a widespread shortage of highly skilled workers in the information and communication technologies (ICT) sector in the labour markets of Member States, higher professional skills should be considered to be equivalent to higher education qualifications for the purpose of applying for an EU Blue Card in respect of two higher positions: Information and Communications Technology Services Managers (International Standard Classification of Occupation (ISCO)-08 classification 133) and Information and Communications Technology Professionals (ISCO-08 classification 25). Considering that a bachelor degree takes at least 3 years to complete, the relevant period of required professional experience should be 3 years. The length of that period is also justified given the fast pace of technological evolution in the ICT sector and the changing needs of employers. (11) Member States are encouraged to facilitate the assessment and validation of higher professional skills for the purposes of the EU Blue Card. (12) It is envisaged that the list of occupations set out in an annex to this Directive could be amended, in particular following assessments by the Commission to determine whether to do so, on the basis of, among other sources, the information provided by the Member States regarding the needs of their labour markets, for the purpose of recognising professional experience under this Directive in other fields of activity. The Commission should conduct such assessments every 2 years. (13) For occupations not listed in the annex, it should be possible for Member States to accept applications for an EU Blue Card on the basis of evidence of higher professional skills, attested by at least 5 years of professional experience at a level comparable to higher education qualifications and which is relevant to the profession or sector specified in the work contract or binding job offer. (14) The concept of highly qualified employment entails that the person employed not only has a high level of competence, as proven by higher professional qualifications, but also that the work to be carried out is inherently regarded as demanding such competence. While in the modern labour market a direct link between the qualifications and the job is not always and necessarily required, the tasks and duties related to the work contract for highly qualified employment should be so specialised and complex that the required level of competence to perform those duties is usually associated with the completion of educational programmes and the resulting qualifications at International Standard Classification of Education (ISCED) 2011 levels 6, 7 and 8, or, where appropriate, at the broadly equivalent European Qualifications Framework (EQF) levels 6, 7 and 8, in accordance with the law of the Member State concerned, or, for specific occupations, with comparable higher professional skills. (15) This Directive should not affect the right of Member States to determine volumes of admission of third-country nationals coming from third countries to their territory in order to seek work in accordance with Article 79(5) of the Treaty on the Functioning of the European Union (TFEU). On that basis, Member States should be able to either consider an application for an EU Blue Card to be inadmissible or to reject it. (16) Beneficiaries of international protection as defined in Article 2, point (a), of Directive 2011/95/EU of the European Parliament and of the Council (8) have a wide set of rights, including access to the labour market in the Member State that granted them international protection. In order to enhance their labour market opportunities across the Union, beneficiaries of international protection who are highly qualified should be entitled to apply for an EU Blue Card in Member States other than that which granted them international protection. In those other Member States, they should be subject to the same rules as any other third country national falling within the scope of this Directive, and this Directive should have no impact on their status in the Member State that granted them international protection. Beneficiaries of international protection are also entitled to apply for an EU Blue Card in the Member State that granted them international protection. In such cases, for reasons of legal clarity and coherence, the provisions on equal treatment and family reunification of this Directive should not apply. Those rights should remain regulated under the asylum acquis and, where applicable, under Council Directive 2003/86/EC (9). (17) The transfer of responsibility for beneficiaries of international protection is outside the scope of this Directive. The protected status and the rights associated with international protection should not be transferred to another Member State on the basis of the issuance of an EU Blue Card. (18) In order to facilitate the independent intra-EU mobility and business activities of highly qualified third-country nationals who are beneficiaries of the right to free movement, such third-country nationals should be given access to the EU Blue Card in accordance with the same rules as any other third-country national falling within the scope of this Directive. This entitlement concerns persons enjoying free movement rights based on family ties to a Union citizen in accordance with relevant legislation and should apply regardless of whether the Union citizen of reference has exercised the fundamental right to move and reside freely under Article 21 TFEU and regardless of whether the third-country national concerned was first an EU Blue Card holder or a beneficiary of the right to free movement. Such EU Blue Card holders should thus be entitled to engage in highly qualified employment, perform business trips and take up residence in different Member States regardless of whether the third-country national accompanies the Union citizen of reference. The rights that such third-country nationals acquire as EU Blue Card holders should be without prejudice to rights they may enjoy under Directive 2004/38/EC of the European Parliament and of the Council (10). For reasons of legal clarity and coherence, in terms of family reunification and equal treatment, the rules under Directive 2004/38/EC should prevail. All provisions regarding the beneficiaries of the right to free movement in this Directive should also apply to third-country nationals who enjoy rights of free movement equivalent to those of Union citizens under agreements either between the Union and the Member States on the one hand, and third countries on the other, or between the Union and third countries. (19) This Directive should not apply to third-country nationals who apply to reside in a Member State as researchers in order to carry out research projects, as they fall within the scope of Directive (EU) 2016/801 of the European Parliament and of the Council (11), which introduced a specific procedure for admitting third-country nationals for the purpose of research. However, legally residing third-country nationals admitted under Directive (EU) 2016/801 should be entitled to apply for an EU Blue Card under this Directive. Legally residing EU Blue Card holders should also be entitled to apply to reside as researchers under Directive (EU) 2016/801. In order to ensure such a possibility, Directive (EU) 2016/801 should be amended accordingly. (20) Although this Directive does not apply to third-country nationals who apply to be admitted to the Union as intra-corporate transferees pursuant to Directive 2014/66/EU of the European Parliament and of the Council (12), intra-corporate transferees legally residing in the Union should be entitled to apply for an EU Blue Card under this Directive for purposes other than those covered under Directive 2014/66/EU. (21) It is necessary to provide for a flexible, demand-driven, clear and balanced admission system based on objective criteria, such as the applicant having a work contract or binding offer for a job of at least 6 months duration, compliance with the applicable law, collective agreements or national practices in the relevant occupational branches, a salary threshold adaptable by the Member States to the situation in its labour market and the applicant having higher professional qualifications or, where appropriate, higher professional skills. (22) This Directive should be without prejudice to national procedures on the recognition of diplomas. In order to evaluate whether the third-country national concerned possesses higher education or equivalent qualifications, reference should be made to ISCED 2011 levels 6, 7 and 8 or, where appropriate, to the broadly equivalent EQF levels 6, 7 and 8, in accordance with the law of the Member State concerned. (23) Member States are encouraged to facilitate the recognition of documents attesting to the relevant higher professional qualifications of the third-country national concerned and, as regards beneficiaries of international protection who may not have the necessary documents, to establish arrangements for the appropriate assessment and validation of their prior higher education qualifications or, where relevant, higher professional skills. (24) In order to ensure a sufficient level of harmonisation of admission conditions throughout the Union, both a lower and an upper factor for the salary threshold should be determined. The lower and upper limits for setting the national salary threshold should be determined by multiplying those lower and upper factors by the average gross annual salary in the Member State concerned. A salary threshold should be chosen within the range of the lower and upper limits, after consulting the social partners in accordance with national practices. That salary threshold should determine the minimum salary which an EU Blue Card holder is to earn. Therefore, in order to obtain an EU Blue Card, applicants should earn a salary which is equal to or greater than the salary threshold chosen by the Member State concerned. (25) Member States should be able to provide for a lower salary threshold for specific professions where the Member State concerned considers that there is a particular shortage of available workers and where such professions belong to major group 1 or 2 of the ISCO classification. In any event, such a salary threshold should not be lower than 1,0 times the average gross annual salary in the Member State concerned. (26) In line with the priorities of the New Skills Agenda for Europe, set out in the Commission communication of 10 June 2016, in particular to improve skills matching and to tackle skills shortages, Member States are encouraged, where appropriate, after consulting the social partners, to compile lists of sectors of employment which face a shortage of highly qualified workers. (27) Member States should be able to provide for a lower salary threshold to benefit third-country nationals during a certain period following their graduation. That period should apply each time that the third-country national reaches a level of education relevant for the purposes of this Directive, namely ISCED 2011 level 6, 7 or 8 or, where appropriate, EQF level 6, 7 or 8, in accordance with the law of the Member State concerned. That period should apply where the third-country national applies for an initial or renewal of an EU Blue Card within 3 years from the date of obtaining the relevant qualifications and, in addition, where that third-country national applies for the renewal of an EU Blue Card within 24 months of the issuance of the initial EU Blue Card. After those grace periods, which could run in parallel, have elapsed, young professionals can reasonably be expected to have gained sufficient professional experience in order to fulfil the regular salary threshold. In any event, such a lower salary threshold should not be lower than 1,0 times the average gross annual salary in the Member State concerned. (28) The conditions of entry and residence of third-country nationals for the purpose of highly qualified employment, including the eligibility criteria related to a salary threshold, should be defined. The salary threshold set by the Member State should not aim to determine salaries and therefore should not derogate from the rules or practices at Member State level or from collective agreements, and should not be used to constitute any harmonisation in that field. The salary paid to the EU Blue Card holder should not be lower than the applicable salary threshold but may be higher, as agreed between the employer and the third-country national, in line with market conditions, labour law, collective agreements and practices in the Member State concerned. This Directive should fully respect the competences of Member States, particularly as regards employment, labour and social matters. (29) Member States should be able to require the third-country national to provide his or her address at the time of the application. In the event that the third-country national does not yet know his or her future address, Member States should accept a temporary address, which could be the address of the employer. (30) The period of validity of the EU Blue Card should be at least 24 months. However, where the duration of the work contract is shorter, the EU Blue Card should be issued for at least the duration of the work contract plus 3 months, subject to a maximum of 24 months. If the third-country national holds a travel document whose period of validity is shorter than 24 months or shorter than the duration of the work contract, the EU Blue Card should be issued for at least the period of validity of the travel document. Third-country nationals should be allowed to renew their travel document while holding an EU Blue Card. (31) Member States should reject applications for EU Blue Cards and should be allowed to withdraw or refuse to renew EU Blue Cards where there is a threat to public policy, public security or public health. A threat to public health is to be understood as that term is defined in Article 2, point 21, of Regulation (EU) 2016/399 of the European Parliament and of the Council (13). Any rejection of an application on grounds of public policy or public security should be based on the individual behaviour of the person concerned, in accordance with the principle of proportionality. Illness or disability suffered after the third-country national was admitted to the territory of the first Member State should not constitute the sole ground for withdrawing or refusing to renew an EU Blue Card or for not issuing an EU Blue Card in a second Member State. Moreover, Member States should have the possibility of not withdrawing or not refusing to renew an EU Blue Card where the obligation to present a valid work contract or to meet the applicable salary threshold is temporarily not met due to illness, disability or parental leave. (32) Member States should be able to withdraw or refuse to renew an EU Blue Card where the EU Blue Card holder has failed to comply with the conditions for mobility under this Directive, including in cases of the abusive use of mobility rights, for example where the holder has not respected the allowed period for carrying out a business activity, has not submitted an application for long-term mobility within the required time frame in second Member States, or has applied for an EU Blue Card in a second Member State and begun employment sooner than allowed where it was clear that the conditions for mobility would not be fulfilled and the application would be rejected. (33) Any decision to reject an application for an EU Blue Card or to withdraw or refuse to renew an EU Blue Card should take into consideration the specific circumstances of the case and should be proportionate. In particular, where the ground for rejection, withdrawal or refusal to renew relates to the conduct of the employer, the minor misconduct of the employer should in no case constitute the sole ground for rejecting an application for an EU Blue Card or withdrawing or refusing to renew an EU Blue Card. (34) A decision rejecting an application for an EU Blue Card does not affect the right of the third-country national concerned to submit another application. The submission of such a new application does not authorise the third-country national concerned to remain in the territory of the Member State concerned, except where provided for by national law. (35) Once all the conditions for admission are fulfilled, Member States should issue an EU Blue Card within a specified time limit. If a Member State only issues residence permits on its territory and all the conditions of this Directive relating to admission are fulfilled, the Member State should grant the third-country national concerned the requisite visa. It should be ensured that the competent authorities cooperate effectively for that purpose. In the event that the Member State does not issue visas, it should grant the third-country national concerned an equivalent permit allowing entry. (36) The rules on processing times for EU Blue Card applications should guarantee the swift issuance of permits in all cases. The processing time for examining an application for an EU Blue Card should not include the time required for the recognition of professional qualifications, where applicable, or the time required for issuing a visa, if required. In the event that an EU Blue Card expires during the renewal procedure, the third-country national should be entitled to stay, work and enjoy the rights provided for under this Directive in the territory of the Member State which issued the EU Blue Card, until the decision on the application is taken by the competent authorities, but that third-country national should not have the right to move to a second Member State. (37) Where a Member State has determined that an application for an EU Blue Card or for intra-EU mobility is to be made by the employer, that Member State should not restrict the procedural safeguards enjoyed by the third-country national concerned during the application procedure or the rights enjoyed by the EU Blue Card holder during the period of employment or the EU Blue Card renewal procedure. (38) The format of the EU Blue Card should comply with Council Regulation (EC) No 1030/2002 (14), thus enabling Member States to refer to the information on the conditions under which the person concerned is permitted to work. Member States should be able to provide additional information in paper form or to store such information in electronic form in accordance with Article 4 of that Regulation and point (a)(16) of the Annex to that Regulation, in order to provide more precise information on the employment activity concerned. The provision of such additional information should be optional for Member States and should not constitute an additional requirement that would compromise the single permit and the single application procedure. (39) The Member State concerned should ensure that applicants have the right to challenge, before a court or tribunal, any decision rejecting an application for an EU Blue Card or any decision not to renew or to withdraw an EU Blue Card. This should be without prejudice to the possibility of designating an administrative authority to carry out a prior administrative review of such decisions. (40) Since this Directive aims to address labour and skills shortages in key sectors in labour markets, a Member State should be able to check whether a vacancy which an applicant for an EU Blue Card intends to fill could instead be filled from the national or Union workforce, or by third-country nationals who are already lawfully resident in that Member State and who already form part of its labour market by virtue of Union or national law, or by EU long-term residents wishing to move to that Member State for highly qualified employment in accordance with Chapter III of Council Directive 2003/109/EC (15). In the event that Member States decide to make use of that possibility, they should communicate this in a clear, accessible and transparent way to applicants and employers, including through online media. Such checks should not be part of the EU Blue Card renewal procedure. In cases of long-term mobility, a Member State should only be able to take into account the labour market situation if that Member State has also introduced checks for applicants coming from third countries. (41) In implementing this Directive, Member States should refrain from pursuing active recruitment in developing countries in sectors suffering from a lack of personnel. Ethical recruitment policies and principles that apply to public and private sector employers should be developed in key sectors, for example in the health sector. This is consistent with the Union\u2019s commitment to the 2010 World Health Organization\u2019s Global Code on the International Recruitment of Health Personnel, as well as with the conclusions of the Council and the Member States of 14 May 2007 on the European Programme for Action to tackle the critical shortage of health workers in developing countries (2007-13), and to the education sector. It is appropriate to strengthen those principles and policies by the development and application of mechanisms, guidelines and other tools to facilitate, as appropriate, circular and temporary migration, as well as other measures that would minimise the negative impact, and maximise the positive impact, of highly qualified immigration on developing countries in order to turn brain drain into brain gain. (42) Member States should have the option of applying a simplified procedure for employers. That procedure should allow recognised employers to take advantage of simpler procedures and admission conditions under this Directive. However, Member States should include sufficient safeguards against abuse. In accordance with the principle of proportionality, those safeguards must take into account the gravity and nature of the misconduct. If, at the time of renewal of an EU Blue Card, the employer is no longer recognised, the regular admission conditions should apply to the renewal of that EU Blue Card, unless the third-country national concerned is employed by another recognised employer. (43) In order to ensure that the criteria for admission continue to be fulfilled, Member States should be allowed to require that, during the first 12 months of legal employment as an EU Blue Card holder, any change of employer or other significant changes be communicated to the competent authorities and that the competent authorities carry out a check of the labour market situation. After that 12-month period, Member States should only be allowed to require the EU Blue Card holder to inform competent authorities of a change of employer or a change that affects the fulfilment of the criteria for admission set out in this Directive, including, where necessary, the new work contract. No check of the labour market situation should be carried out. The assessment carried out by Member States should be limited to the elements that have changed. (44) In order to promote innovative entrepreneurship, Member States should be able to give third-country nationals admitted under this Directive the possibility of exercising a self-employed activity in parallel with their activity under this Directive without it affecting their rights of residence as EU Blue Card holders. This should be without prejudice to the continuing obligation to meet the conditions for admission under this Directive, and therefore the EU Blue Card holder should remain in highly qualified employment. Member States should be able to lay down the conditions for access to self-employed activity in their national law. Member States should also be entitled to limit the scope of the allowed self-employed activity. Member States should give EU Blue Card holders access to self-employed activities under conditions that are no less favourable than those provided for under existing national schemes. Any income derived from self-employment should not contribute towards meeting the salary threshold required to qualify as an EU Blue Card holder. (45) In order to enhance the EU Blue Card holder\u2019s contribution through his or her higher professional qualifications, Member States should also be able to lay down provisions in their national law allowing EU Blue Card holders to engage in other professional activities which are complementary to their main activity as an EU Blue Card holder. Any income derived from those professional activities should not contribute towards meeting the salary threshold required to qualify as an EU Blue Card holder. (46) Equal treatment should be granted to EU Blue Card holders in respect of the branches of social security listed in Article 3 of Regulation (EC) No 883/2004 of the European Parliament and of the Council (16). This Directive does not harmonise the social security legislation of Member States. It is limited to applying the principle of equal treatment in the field of social security to the third-country nationals falling within its scope. (47) In the event of mobility between Member States, Regulation (EU) No 1231/2010 of the European Parliament and of the Council (17) applies. This Directive should not confer more rights on the mobile EU Blue Card holder than those already provided for in existing Union law in the field of social security for third-country nationals who have cross-border interests between Member States. (48) Professional qualifications acquired by a third-country national in another Member State should be recognised in the same way as those of Union citizens. Qualifications acquired in a third country should be taken into account in accordance with Directive 2005/36/EC of the European Parliament and of the Council (18). This Directive should be without prejudice to the conditions set out under national law for the exercise of regulated professions. It should not prevent a Member State from maintaining national restrictions on access to employment which entails at least occasional involvement in the exercise of public authority and the responsibility for safeguarding the general interest of the State, or from maintaining national rules on activities that are reserved to nationals of that Member State, Union citizens or citizens of another country in the European Economic Area (EEA citizen), including in cases of mobility to other Member States, where such restrictions or rules existed at the time of the entry into force of this Directive. (49) The rights acquired by a beneficiary of international protection as an EU Blue Card holder should be without prejudice to the rights enjoyed by that person under Directive 2011/95/EU and under the Convention Relating to the Status of Refugees of 28 July 1951 as amended by the New York Protocol of 31 January 1967 (the \u2018Geneva Convention\u2019) in the Member State which granted the international protection. In that Member State, in order to avoid conflicting rules, the provisions on equal treatment and family reunification of this Directive should not apply. Persons who are beneficiaries of international protection in one Member State and EU Blue Card holders in another should enjoy the same rights as any other EU Blue Card holder in the latter Member State, including equality of treatment with nationals of the Member State of residence and family reunification rights. The status of a beneficiary of international protection is independent of whether the beneficiary is also an EU Blue Card holder and the validity of that EU Blue Card. (50) Favourable conditions for family reunification and access to work for spouses should be a fundamental element of this Directive in order to better attract highly qualified workers from third-countries. Specific derogations from Directive 2003/86/EC, which is applicable in the first and the second Member State of residence, should be provided for in order to reach that aim. Member States should be able to restrict the scope of self-employed activities in which spouses may engage under the same conditions as apply to EU Blue Card holders. Conditions related to integration or waiting periods should not be applied before allowing family reunification, as highly qualified workers and their families are likely to have a favourable starting point regarding integration in the host community. With the aim of facilitating the swift entry of highly qualified workers, residence permits to their family members should be issued at the same time as the EU Blue Card where the relevant conditions are fulfilled and the applications were lodged simultaneously. (51) Derogations from Directive 2003/109/EC should be provided for in order to attract highly qualified workers from third countries and to encourage their continued stay in the Union, while enabling mobility within the Union and circular migration. EU Blue Card holders who have availed themselves of the possibility of moving from one Member State to another Member State should be granted easier access to EU long-term resident status in a Member State, in particular by allowing them to cumulate periods of residence in different Member States, provided that they can demonstrate the number of years of legal and continuous residence required under Article 4(1) of Directive 2003/109/EC as holders of an EU Blue Card, of a national permit for highly qualified employment or of an authorisation as a student or researcher in accordance with Directive (EU) 2016/801, or as beneficiaries of international protection. They should also demonstrate 2 years of legal and continuous residence as an EU Blue Card holder immediately prior to the submission of the relevant application in the territory of the Member State where the application for EU long-term resident status in a Member State is submitted. As provided for in Directive 2003/109/EC, only half of the periods of residence for study purposes are allowed to be taken into account in the calculation of the 5 years of legal and continuous residence in the Member States where periods of residence for study purposes are taken into account for the calculation of continuous residence. (52) In order to foster the mobility of highly qualified workers from third countries between the Union and their countries of origin, derogations from Directive 2003/109/EC should be provided for in order to allow longer periods of absence than those provided for in that Directive after highly qualified third-country workers have acquired EU long-term resident status in a Member State. (53) The occupational and geographical mobility of highly qualified workers from third countries should be recognised as an important contributor to improving labour market efficiency across the Union, to addressing skills shortages and to offsetting regional imbalances. Mobility within the Union should be facilitated. (54) This Directive is without prejudice to the provisions of Directives 96/71/EC (19) and 2014/67/EU (20) of the European Parliament and of the Council. (55) Existing legal uncertainty surrounding business trips taken by highly qualified workers from third countries should be addressed by defining the notion of business trips and setting out a list of activities that in any case should be considered as business activities in all Member States. Those activities are to be directly linked to the interests of the employer in the first Member State and should be related to the duties of the EU Blue Card holder in the employment for which the EU Blue Card was granted. Second Member States should not be allowed to require EU Blue Card holders engaging in business activities to have a visa, work permit or any authorisation other than the EU Blue Card. Where the EU Blue Card is issued by a Member State that does not apply the Schengen acquis in full, its holder should be entitled to enter and stay in one or several second Member States for the purpose of business activities for up to 90 days in any 180-day period. (56) EU Blue Card holders should be allowed to move to a second Member State under simplified conditions where they intend to apply for a new EU Blue Card on the basis of an existing work contract or binding job offer. Second Member States should not be allowed to require that EU Blue Card holders have any authorisation other than the EU Blue Card issued by the first Member State. As soon as an EU Blue Card holder submits a complete application for a new EU Blue Card in a second Member State within the deadline provided for in this Directive, it should be possible for that Member State to allow the EU Blue Card holder to begin employment. EU Blue Card holders should be entitled to begin employment at the latest 30 days after submitting the application for a new EU Blue Card. Mobility should be demand-driven and therefore a work contract should always be required in the second Member State, all the conditions under the applicable law, set in collective agreements or established by practices in the relevant occupational branches should be met and the salary should satisfy the threshold set by the second Member State in accordance with this Directive. (57) Where EU Blue Card holders intend to apply for an EU Blue Card in a second Member State in order to exercise a regulated profession, their professional qualifications should be recognised in the same way as those of Union citizens exercising the right to free movement, in accordance with Directive 2005/36/EC and other applicable Union and national law. (58) While some special rules are laid down in this Directive regarding entry and stay in a second Member State for the purpose of business activities and moving to a second Member State to reside and work there under the EU Blue Card in its territory, all the other rules governing the movement of persons across borders as laid down in the relevant provisions of the Schengen acquis apply. (59) Where the EU Blue Card is issued by a Member State that does not apply the Schengen acquis in full, and the EU Blue Card holder, in cases of mobility as provided for in this Directive, crosses an external border within the meaning of Regulation (EU) 2016/399 into the territory of a second Member State, that Member State should be entitled to require evidence that the EU Blue Card holder is entering its territory either for the purpose of business activities or in order to reside and work there under the EU Blue Card on the basis of a work contract or binding job offer. In the case of mobility for carrying out business activities, that second Member State should be able to require evidence of the business purpose of the stay, such as invitations, entry tickets, or documents describing the business activities of the relevant company and the position of the EU Blue Card holder in that company. (60) Where the EU Blue Card holder moves to a second Member State to apply for an EU Blue Card and he or she is accompanied by family members, that Member State should be able to require those family members to present their residence permits that were issued in the first Member State. In addition, in cases of the crossing of an external border within the meaning of Regulation (EU) 2016/399, Members States that apply the Schengen acquis in full should consult the Schengen Information System and should refuse entry to, or object to the mobility of, persons for whom an alert for the purposes of refusing entry or stay, as referred to in Regulation (EC) No 1987/2006 of the European Parliament and of the Council (21), has been issued in that system. (61) Where an EU Blue Card holder moves to a second Member State on the basis of an EU Blue Card issued by the first Member State and the second Member State rejects that EU Blue Card holder\u2019s application for a new EU Blue Card, this Directive should allow the second Member State to request that the EU Blue Card holder leave its territory. Where the EU Blue Card holder still has a valid EU Blue Card issued by the first Member State, the second Member State should be able to request that the EU Blue Card holder go back to the first Member State in accordance with Directive 2008/115/EC of the European Parliament and of the Council (22). Where the EU Blue Card issued by the first Member State has been withdrawn or has expired during the examination of the application, it should be possible for the second Member State to decide either to return the EU Blue Card holder to a third country in accordance with Directive 2008/115/EC, or to request the first Member State to allow the re-entry of the EU Blue Card holder into its territory without unnecessary formalities or delay. In the latter case, the first Member State should issue the EU Blue Card holder with a document allowing re-entry into its territory. (62) For the purposes of the residence of beneficiaries of international protection, it is necessary to ensure that when such beneficiaries move to a Member State other than the Member State that granted them international protection, the other Member State is informed of the international protection background of the persons concerned in order to be able to comply with its obligations regarding the principle of non-refoulement. (63) Where a Member State intends to expel a person who has acquired an EU Blue Card in that Member State and who is a beneficiary of international protection in another Member State, that person should enjoy protection against refoulement in accordance with Directive 2011/95/EU and Article 33 of the Geneva Convention. (64) Where the expulsion of a beneficiary of international protection from the territory of a Member State is permitted under Directive 2011/95/EU, the Member State should ensure that all information is obtained from relevant sources, including, where appropriate, from the Member State that granted international protection, and that the information is thoroughly assessed with a view to guaranteeing that the decision to expel that beneficiary complies with Article 4 of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019). (65) Specific reporting provisions should be provided for to monitor the implementation of this Directive, with a view to identifying and possibly counteracting its possible impact in terms of brain drain in developing countries and in order to avoid brain waste. (66) Since the objectives of this Directive, namely the establishment of a special admission procedure and the adoption of conditions of entry and residence applicable to third-country nationals for the purpose of highly qualified employment and their family members, and the establishment of rights in relation thereto, cannot be sufficiently achieved by the Member States, especially as regards ensuring their mobility between Member States and offering a clear and single set of admission criteria across the Member States in order to better exploit the Union\u2019s overall attractiveness, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (67) This Directive respects the fundamental rights and observes the principles recognised by the Charter in accordance with Article 6 TEU. (68) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (69) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application. (70) In accordance with Articles 1 and 2 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the Area of Freedom, Security and Justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, Ireland is not taking part in the adoption of this Directive and is not bound by it or subject to its application. (71) Directive 2009/50/EC should therefore be repealed, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Directive lays down: (a) the conditions of entry and residence for more than 3 months in the territory of the Member States, and the rights, of third-country nationals for the purpose of highly qualified employment and of their family members; (b) the conditions of entry and residence, and the rights, of third-country nationals and of their family members, referred to in point (a), in Member States other than the Member State which first granted an EU Blue Card. Article 2 Definitions For the purposes of this Directive: (1) \u2018third-country national\u2019 means any person who is not a citizen of the Union within the meaning of Article 20(1) TFEU; (2) \u2018highly qualified employment\u2019 means the employment of a person who: (a) in the Member State concerned, is protected as an employee under national employment law or in accordance with national practice, irrespective of the legal relationship, for the purpose of exercising genuine and effective work for, or under the direction of, another person; (b) is paid for that work; and (c) has the required higher professional qualifications; (3) \u2018EU Blue Card\u2019 means a residence permit bearing the term \u2018EU Blue Card\u2019 that entitles its holder to reside and work in the territory of a Member State under the terms of this Directive; (4) \u2018first Member State\u2019 means the Member State which first grants a third-country national an EU Blue Card; (5) \u2018second Member State\u2019 means any Member State in which the EU Blue Card holder intends to exercise or exercises the right of mobility within the meaning of this Directive, other than the first Member State; (6) \u2018family members\u2019 means third-country nationals who are family members as referred to in Article 4(1) of Directive 2003/86/EC; (7) \u2018higher professional qualifications\u2019 means qualifications attested by evidence of higher education qualifications or higher professional skills; (8) \u2018higher education qualifications\u2019 means any diploma, certificate or other evidence of formal qualifications issued by a competent authority attesting to the successful completion of a post-secondary higher education or equivalent tertiary education programme, namely a set of courses provided by an educational establishment recognised as a higher education institution or equivalent tertiary educational institution by the State in which it is situated, where the studies needed to acquire those qualifications last at least 3 years and correspond at least to ISCED 2011 level 6 or, where appropriate, to EQF level 6, in accordance with national law; (9) \u2018higher professional skills\u2019 means: (a) as concerns the occupations listed in Annex I, knowledge, skills and competences attested by professional experience at a level comparable to higher education qualifications, which are relevant to the profession or sector specified in the work contract or binding job offer, and which have been acquired over the duration set out in Annex I for each relevant occupation; (b) as concerns other occupations, only where provided for by national law or national procedures, knowledge, skills and competences attested by at least 5 years of professional experience at a level comparable to higher education qualifications and which are relevant to the profession or sector specified in the work contract or binding job offer; (10) \u2018professional experience\u2019 means the actual and lawful pursuit of the profession concerned; (11) \u2018regulated profession\u2019 means a regulated profession as defined in Article 3(1), point (a), of Directive 2005/36/EC; (12) \u2018unregulated profession\u2019 means a profession that is not a regulated profession; (13) \u2018business activity\u2019 means a temporary activity directly related to the business interests of the employer and to the professional duties of the EU Blue Card holder based on the work contract in the first Member State, including attending internal or external business meetings, attending conferences or seminars, negotiating business deals, undertaking sales or marketing activities, exploring business opportunities, or attending and receiving training; (14) \u2018international protection\u2019 means international protection as defined in Article 2, point (a), of Directive 2011/95/EU. Article 3 Scope 1. This Directive applies to third-country nationals who apply to be admitted, or who have been admitted, to the territory of a Member State for the purpose of highly qualified employment under this Directive. 2. This Directive does not apply to third-country nationals: (a) who seek international protection and are awaiting a decision on their status or who are beneficiaries of temporary protection in accordance with Council Directive 2001/55/EC (23) in a Member State; (b) who seek protection in accordance with national law, international obligations or practice of a Member State and are awaiting a decision on their status, or who are beneficiaries of protection in accordance with national law, international obligations or practice of a Member State; (c) who apply to reside in a Member State as researchers within the meaning of Directive (EU) 2016/801 in order to carry out a research project; (d) who enjoy EU long-term resident status in a Member State in accordance with Directive 2003/109/EC and exercise their right to reside in another Member State in order to carry out an economic activity in an employed or self-employed capacity; (e) who enter a Member State under commitments contained in an international agreement facilitating the entry and temporary stay of certain categories of trade- and investment-related natural persons, with the exception of third-country nationals who have been admitted to the territory of a Member State as intra-corporate transferees pursuant to Directive 2014/66/EU; (f) whose expulsion has been suspended for reasons of fact or law; (g) who are covered by Directive 96/71/EC for the duration of their posting to the territory of the Member State concerned; or (h) who, under agreements between the Union and the Member States on the one hand, and third countries on the other, as nationals of those third countries, enjoy rights of free movement equivalent to those of Union citizens. 3. This Directive is without prejudice to the right of Member States to issue residence permits other than an EU Blue Card for the purpose of highly qualified employment. Such residence permits shall not confer a right of residence in other Member States as provided for in this Directive. Article 4 More favourable provisions 1. This Directive is without prejudice to more favourable provisions of: (a) Union law, including bilateral or multilateral agreements concluded between the Union or the Union and the Member States on the one hand, and one or more third countries on the other; and (b) bilateral or multilateral agreements concluded between one or more Member States and one or more third countries. 2. This Directive shall not affect the right of Member States to adopt or retain more favourable provisions in respect of Article 8(5), Article 11, Article 15(4), Articles 16 and 17 and Article 18(4). CHAPTER II CRITERIA FOR ADMISSION, REFUSAL AND WITHDRAWAL Article 5 Criteria for admission 1. As regards the admission of a third-country national under this Directive, an applicant for an EU Blue Card shall: (a) present a valid work contract or, as provided for in national law, a binding job offer for highly qualified employment for a period of at least 6 months in the Member State concerned; (b) for unregulated professions, present documents attesting to relevant higher professional qualifications in relation to the work to be carried out; (c) for regulated professions, present documents attesting to the fulfilment of the conditions set out under national law for the exercise by Union citizens of the regulated profession specified in the work contract or binding job offer, in accordance with national law; (d) present a valid travel document, as determined by national law, and, if required, an application for a visa, a valid visa or, where applicable, a valid residence permit or valid long-stay visa; (e) provide evidence of having or, if provided for by national law, having applied for, sickness insurance for all the risks normally covered for nationals of the Member State concerned for periods when no such insurance coverage or corresponding entitlement to benefits is provided for in connection with, or resulting from, the work contract. 2. Member States shall require that the conditions under the applicable law, set in collective agreements or established by practices in the relevant occupational branches for highly qualified employment are met. 3. In addition to the requirements laid down in paragraphs 1 and 2, the amount of gross annual salary resulting from the monthly or annual salary specified in the work contract or binding job offer shall not be lower than the salary threshold set and published for that purpose by the Member State concerned. The salary threshold referred to in the first subparagraph shall be set by the Member State concerned, after consulting the social partners according to national practices. It shall be at least 1,0 times, but not higher than 1,6 times, the average gross annual salary in the Member State concerned. 4. By way of derogation from paragraph 3, for employment in professions in which there is particular need of third-country national workers and which belong to major groups 1 and 2 of the ISCO classification, a Member State may apply a lower salary threshold that is at least 80 % of the salary threshold set by that Member State in accordance with paragraph 3, provided that the lower salary threshold is not lower than 1,0 times the average gross annual salary in that Member State. 5. By way of derogation from paragraph 3, as regards third-country nationals who have obtained a higher education qualification no more than 3 years before submitting the application for an EU Blue Card, a Member State may apply a lower salary threshold that is at least 80 % of the salary threshold set by that Member State in accordance with paragraph 3, provided that the lower salary threshold is not lower than 1,0 times the average gross annual salary in the Member State concerned. Where the EU Blue Card issued during the period of 3 years is renewed, the salary threshold referred to in the first subparagraph shall continue to apply if: (a) the initial period of 3 years has not elapsed; or (b) a period of 24 months after the issuance of the first EU Blue Card has not elapsed. 6. Where an application for an EU Blue Card concerns a third-country national who holds a national residence permit for the purpose of highly qualified employment issued by the same Member State, that Member State shall not: (a) require the applicant to present the documents provided for in paragraph 1, point (b) or (c), if the relevant higher professional qualifications were already verified in the context of the application for the national residence permit; (b) require the applicant to present the evidence provided for in paragraph 1, point (e), of this Article unless the application is submitted in the context of a change of employment, in which case Article 15 shall apply accordingly; and (c) apply Article 7(2), point (a), unless the application is submitted in the context of a change of employment, in which case Article 15 shall apply accordingly. 7. Member States may require the third-country national concerned to provide his or her address in their territory. Where the law of a Member State requires an address to be provided at the time of application, and the third-country national concerned does not yet know his or her future address, Member States shall accept a temporary address. In such cases, the third-country national shall provide his or her permanent address at the latest when the EU Blue Card is issued pursuant to Article 9. Article 6 Volumes of admission This Directive shall not affect the right of Member States to determine volumes of admission of third-country nationals in accordance with Article 79(5) TFEU. Article 7 Grounds for rejecting an application for an EU Blue Card 1. A Member State shall reject an application for an EU Blue Card where: (a) Article 5 is not complied with; (b) the documents presented have been fraudulently acquired, falsified or tampered with; (c) the third-country national concerned is considered to pose a threat to public policy, public security or public health; or (d) the employer\u2019s business was established or operates for the main purpose of facilitating the entry of third-country nationals. 2. A Member State may reject an application for an EU Blue Card: (a) where the competent authorities of the Member State, after checking the labour market situation, for example where there is a high level of unemployment, conclude that the vacancy concerned may be filled from the national or Union workforce, or by third-country nationals who are lawfully resident in that Member State and already form part of its labour market by virtue of Union or national law, or by EU long-term residents who wish to move to that Member State for highly qualified employment in accordance with Chapter III of Directive 2003/109/EC; (b) where the employer has failed to meet its legal obligations regarding social security, taxation, labour rights or working conditions; (c) where the employer\u2019s business is being, or has been, wound up under national insolvency laws or carries out no economic activity; (d) where the employer has been sanctioned for the employment of illegally staying third-country nationals in accordance with Article 9 of Directive 2009/52/EC of the European Parliament and of the Council (24), or for undeclared work or illegal employment according to national law; or (e) to ensure ethical recruitment in professions suffering from a lack of qualified workers in the countries of origin, including on the basis of an agreement listing professions for that purpose either between the Union and the Member States on the one hand, and one or more third countries on the other, or between the Member States on the one hand, and one or more third countries on the other. 3. Without prejudice to paragraph 1, any decision to reject an application shall take account of the specific circumstances of the case and shall respect the principle of proportionality. Article 8 Grounds for withdrawing or not renewing an EU Blue Card 1. A Member State shall withdraw or refuse to renew an EU Blue Card where: (a) the EU Blue Card or the documents presented have been fraudulently acquired, falsified or tampered with; (b) the third-country national concerned no longer holds a valid work contract for highly qualified employment; (c) the third-country national concerned no longer holds the qualifications referred to in Article 5(1), point (b) or (c); or (d) the salary of the third-country national concerned no longer meets the salary threshold set in accordance with Article 5(3), (4) or (5), as applicable. 2. A Member State may withdraw or refuse to renew an EU Blue Card: (a) for reasons of public policy, public security or public health; (b) where appropriate, where the employer has failed to meet its legal obligations regarding social security, taxation, labour rights or working conditions; (c) where the EU Blue Card holder does not have sufficient resources to maintain himself or herself and, where applicable, the members of his or her family without having recourse to the social assistance system of that Member State; (d) where the EU Blue Card holder is residing in that Member State for purposes other than those for which he or she was authorised to reside; (e) where the conditions under the applicable law, set in collective agreements or established by practices in the relevant occupational branches for highly qualified employment are no longer met; (f) where the EU Blue Card holder has not complied with the relevant procedures as provided for in Article 15(2), point (a), or in Article 15(3) or (4); (g) where the EU Blue Card holder no longer holds a valid travel document, provided that, prior to withdrawing the EU Blue Card, that Member State had set a reasonable deadline for that EU Blue Card holder to obtain and present a valid travel document; or (h) where the EU Blue Card holder fails to comply with the conditions of mobility under Chapter V. For the purposes of point (c) of the first subparagraph, a Member State shall evaluate the sufficiency of resources by reference to their nature and regularity and may take into account the level of minimum national wages, minimum income or minimum pensions as well as the number of family members of the EU Blue Card holder. Such evaluation shall take into account the contributions of the family members to the household income. 3. By way of derogation from paragraph 2, first subparagraph, point (f), of this Article, a failure to make a communication required under Article 15(2), point (a), or Article 15(3) or (4) shall not be considered to be a sufficient reason for withdrawing or not renewing the EU Blue Card if the EU Blue Card holder proves that the communication did not reach the competent authorities for a reason outside his or her control. 4. By way of derogation from paragraph 1, points (b) and (d), Member States may decide not to withdraw or not to refuse to renew an EU Blue Card where the EU Blue Card holder temporarily, in any case for no longer than 12 months, does not fulfil the criteria for admission set out in Article 5(1), point (a), Article 5(3) or, where applicable, Article 5(4) or (5), as a result of illness, disability or parental leave. 5. By way of derogation from paragraph 1, points (b) and (d), and paragraph 2, first subparagraph, point (c), the EU Blue Card shall not be withdrawn and its renewal shall not be refused in the event of the unemployment of the EU Blue Card holder, except where: (a) the EU Blue Card holder cumulates a period of unemployment exceeding 3 months and has held an EU Blue Card for less than 2 years; or (b) the EU Blue Card holder cumulates a period of unemployment exceeding 6 months and has held an EU Blue Card for at least 2 years. Member States may allow longer periods of unemployment to cumulate before withdrawing or not renewing the EU Blue Card. 6. Where a Member State intends to withdraw or not to renew an EU Blue Card in accordance with paragraph 2, first subparagraph, point (b) or (e), the competent authority shall notify the EU Blue Card holder in advance and shall set a reasonable deadline of at least 3 months for the EU Blue Card holder to seek new employment, subject to the conditions set out in Article 15(1), (2) and (3). The period for seeking employment shall be at least 6 months where the EU Blue Card holder has been previously employed for at least 2 years. 7. Without prejudice to paragraph 1, any decision to withdraw or to refuse to renew an EU Blue Card shall take account of the specific circumstances of the case and shall respect the principle of proportionality. CHAPTER III EU BLUE CARD AND PROCEDURE Article 9 EU Blue Card 1. Where a third-country national fulfils the criteria set out in Article 5 and where no grounds for rejection pursuant to Article 7 apply, he or she shall be issued with an EU Blue Card. Where a Member State only issues residence permits on its territory and the third-country national fulfils all the admission conditions laid down in this Directive, the Member State concerned shall issue him or her with the requisite visa to obtain an EU Blue Card. 2. Member States shall set a standard period of validity for the EU Blue Card, which shall be at least 24 months. If the EU Blue Card holder\u2019s work contract covers a shorter period, the EU Blue Card shall be valid for at least the duration of the work contract plus 3 months, but for no longer than the standard period referred to in the first sentence. However, if the period of validity of the EU Blue Card holder\u2019s travel document is shorter than the period of validity of the EU Blue Card that would apply under the first or second sentence, the EU Blue Card shall be valid at least for the period of validity of the travel document. 3. The EU Blue Card shall be issued by the competent authorities of the Member State concerned using the uniform format laid down in Regulation (EC) No 1030/2002. In accordance with point (a)(12) of the Annex to that Regulation, Member States may indicate on the EU Blue Card the conditions for access to the labour market set out in Article 15(1) of this Directive. Member States shall enter the words \u2018EU Blue Card\u2019 in the space reserved for the \u2018type of permit\u2019 in the residence permit. Member States may provide additional information related to the employment relationship of the EU Blue Card holder in paper form or store such data in electronic form in accordance with Article 4 of Regulation (EC) No 1030/2002 and point (a)(16) of the Annex thereto. 4. Where a Member State issues an EU Blue Card to a third-country national to whom it has granted international protection, it shall enter the following remark in the EU Blue Card issued to that third-country national, under the heading \u2018Remarks\u2019: \u2018International protection granted by [name of the Member State] on [date]\u2019. Where that Member State withdraws the international protection enjoyed by the EU Blue Card holder, it shall, where appropriate, issue a new EU Blue Card not containing that remark. 5. Where an EU Blue Card is issued by a Member State to a third-country national who is a beneficiary of international protection in another Member State, the Member State issuing the EU Blue Card shall enter the following remark in the EU Blue Card issued to that third-country national, under the heading \u2018Remarks\u2019: \u2018International protection granted by [name of the Member State] on [date]\u2019. Before the Member State enters that remark, it shall notify the Member State that is to be mentioned in that remark that it intends to issue the EU Blue Card and request that Member State to confirm that the EU Blue Card holder is still a beneficiary of international protection. The Member State that is to be mentioned in the remark shall reply no later than 1 month after receiving the request for information. Where international protection has been withdrawn by a final decision, the Member State issuing the EU Blue Card shall not enter that remark. Where, in accordance with the relevant international instruments or national law, responsibility for the international protection of the EU Blue Card holder was transferred to the Member State after it issued an EU Blue Card in accordance with the first subparagraph, that Member State shall amend the remark accordingly within 3 months after the transfer. 6. Where an EU Blue Card is issued by a Member State on the basis of higher professional skills in occupations not listed in Annex I, the Member State issuing the EU Blue Card shall enter the following remark in that EU Blue Card, under the heading \u2018Remarks\u2019: \u2018[Occupation not listed in Annex I]\u2019. 7. During the period of its validity, the EU Blue Card shall entitle its holder to: (a) enter, re-enter and stay in the territory of the Member State issuing the EU Blue Card; and (b) enjoy the rights provided for in this Directive. Article 10 Applications for admission 1. Member States shall determine whether applications for an EU Blue Card are to be made by the third-country national or by the employer. Alternatively, Member States may allow applications to be made by either of the two. 2. An application for an EU Blue Card shall be considered and examined either when the third-country national concerned is residing outside the territory of the Member State to which he or she wishes to be admitted, or when he or she is already residing in the territory of that Member State as holder of a valid residence permit or long-stay visa. 3. By way of derogation from paragraph 2, a Member State may accept, in accordance with its national law, an application for an EU Blue Card submitted by a third-country national who is not in possession of a valid residence permit or long-stay visa but is legally present in its territory. Article 11 Procedural safeguards 1. The competent authorities of the Member State concerned shall adopt a decision on the application for an EU Blue Card and notify the applicant in writing, in accordance with the notification procedures laid down in the law of that Member State. That decision shall be adopted and notified as soon as possible but not later than 90 days after the date of submission of the complete application. Where the employer has been recognised in accordance with Article 13, the decision on the application for an EU Blue Card shall be adopted and notified as soon as possible but not later than 30 days after the date on which the complete application was submitted. 2. Where the documents presented or information provided in support of the application are inadequate or incomplete, the competent authorities shall notify the applicant of the additional documents or information that are required and shall set a reasonable deadline for presenting or providing them. The period referred to in paragraph 1 shall be suspended until the authorities have received the additional documents or information required. If the additional documents or information required have not been provided within that deadline, the application may be rejected. 3. Any decision to reject an application for an EU Blue Card, to withdraw an EU Blue Card or not to renew an EU Blue Card shall be notified in writing to the third-country national concerned and, where relevant, to his or her employer in accordance with the notification procedures set out in the relevant national law. The notification shall specify the reasons for the decision and the competent authority to which an appeal may be submitted, as well as the time limit for submitting an appeal. Member States shall provide an effective judicial remedy, in accordance with national law. 4. An applicant shall be allowed to submit an application for the renewal of his or her EU Blue Card before it expires. Member States may set a deadline of no more than 90 days prior to the expiry of the EU Blue Card for submitting an application for renewal. 5. Where the validity of the EU Blue Card expires during the renewal procedure, Member States shall allow the third-country national to stay in their territory as if he or she were an EU Blue Card holder until the competent authorities have taken a decision on the application for renewal. 6. Where Member States issue national residence permits for the purpose of highly qualified employment, they shall grant EU Blue Card holders the same procedural safeguards as those provided for under their national schemes where the procedural safeguards under such national schemes are more favourable than those provided for in paragraphs 1 to 5. Article 12 Fees Member States may require the payment of fees for the handling of applications in accordance with this Directive. The level of fees imposed by a Member State for the processing of applications shall not be disproportionate or excessive. Where Member States issue national residence permits for the purpose of highly qualified employment, they shall not require EU Blue Card applicants to pay higher fees than those imposed on applicants for national permits. Article 13 Recognised employers 1. Member States may provide for recognition procedures for employers in accordance with their national law or administrative practice for the purposes of a simplified procedure for obtaining an EU Blue Card. Where a Member State provides for such recognition procedures, it shall provide clear and transparent information to the employers concerned in relation to, inter alia, the conditions and criteria for recognition, the period of validity of the recognition and the consequences of non-compliance with the conditions for recognition, including the possible withdrawal or non-renewal of the recognition, as well as any sanctions that apply. The recognition procedures shall not entail disproportionate or excessive administrative burdens or costs for employers, in particular for small and medium-sized enterprises. 2. The simplified procedure shall include the processing of applications in accordance with the second subparagraph of Article 11(1). Applicants shall be exempt from presenting or providing one or more pieces of evidence referred to in Article 5(1), point (b) or (e), or in Article 5(7). 3. Member States may refuse to recognise an employer pursuant to paragraph 1 where a sanction has been imposed on that employer for: (a) the employment of illegally staying third-country nationals in accordance with Directive 2009/52/EC; (b) undeclared work or illegal employment under national law; or (c) failing to meet its legal obligations regarding social security, taxation, labour rights or working conditions. Any decision to refuse to recognise an employer shall take account of the specific circumstances of the case, including the time that has passed since the sanction was imposed, and shall respect the principle of proportionality. 4. Member States may refuse to renew, or may decide to withdraw, the recognition of an employer where the employer has not fulfilled its obligations under this Directive or where the recognition has been fraudulently acquired. 5. Where Member States issue national residence permits for the purpose of highly qualified employment and have established recognition procedures for employers facilitating the issuance of such residence permits, they shall apply the same recognition procedures to applications for EU Blue Cards where the recognition procedures for the issuance of such permits are more favourable than those provided for in paragraphs 1 to 4. Article 14 Sanctions against employers 1. Member States shall provide for sanctions against employers who have not fulfilled their obligations under this Directive. Those sanctions shall be effective, proportionate and dissuasive. 2. Member States shall provide for measures to prevent possible abuses of this Directive. Those measures shall include monitoring, assessment and, where appropriate, inspection in accordance with national law or administrative practice. CHAPTER IV RIGHTS Article 15 Labour market access 1. EU Blue Card holders shall have access to highly qualified employment in the Member State concerned under the conditions provided for in this Article. 2. During the first 12 months of legal employment of the person concerned as an EU Blue Card holder, a Member State may: (a) require that a change of employer or a change which may affect the fulfilment of the criteria for admission as set out in Article 5 be communicated to the competent authorities in that Member State, in accordance with procedures laid down in national law; and (b) subject any change of employer to a check of the labour market situation, provided that that Member State carries out such a check in accordance with Article 7(2), point (a). The right of the EU Blue Card holder to change employment may be suspended for a maximum of 30 days while the Member State concerned checks that the conditions for admission laid down in Article 5 are fulfilled and that the vacancy concerned could not be filled by the persons listed in Article 7(2), point (a). The Member State concerned may oppose the change of employment within those 30 days. 3. After the expiry of the 12-month period referred to in paragraph 2, Member States may require only that a change of employer or a change affecting the fulfilment of the criteria for admission as set out in Article 5 be communicated in accordance with procedures laid down by national law. Such a requirement shall not suspend the right of the EU Blue Card holder to take up and carry out the new employment. 4. During a period of unemployment, the EU Blue Card holder shall be allowed to seek and take up employment in accordance with this Article. The EU Blue Card holder shall communicate the beginning and, where appropriate, the end of the period of unemployment to the competent authorities of the Member State of residence in accordance with the relevant national procedures. 5. Without prejudice to the criteria for admission set out in Article 5, Member States may allow EU Blue Card holders to engage in self-employed activity in parallel to the activity in highly qualified employment in accordance with conditions laid down in national law. This shall not affect the competence of the Member States for limiting the scope of the allowed self-employed activity. Any such self-employed activity shall be subsidiary to the main activity of the person concerned as an EU Blue Card holder. 6. Where Member States issue national residence permits for the purpose of highly qualified employment, they shall guarantee EU Blue Card holders access to self-employed activities under no less favourable conditions than those provided for under the relevant national scheme. 7. Without prejudice to the criteria for admission set out in Article 5, Member States may allow EU Blue Card holders to engage in professional activities other than their main activity as an EU Blue Card holder in accordance with conditions laid down in national law. 8. By way of derogation from paragraph 1, a Member State may retain restrictions on access to employment in accordance with existing national or Union law, provided that such employment activities entail at least occasional involvement in the exercise of public authority and the responsibility for safeguarding the general interest of the State or that such employment activities are reserved to nationals of that Member State, Union citizens or EEA citizens. 9. This Article is without prejudice to the principle of preference for Union citizens where applicable under the relevant Acts of Accession. Article 16 Equal treatment 1. EU Blue Card holders shall enjoy equal treatment with nationals of the Member State issuing the EU Blue Card as regards: (a) terms of employment, including the minimum working age, and working conditions, including pay and dismissal, working hours, leave and holidays, as well as health and safety requirements at the workplace; (b) freedom of association and affiliation and membership of an organisation representing workers or employers or of any organisation whose members are engaged in a specific occupation, including the rights and benefits conferred by such organisations, without prejudice to the national provisions on public policy and public security; (c) education and vocational training; (d) recognition of diplomas, certificates and other professional qualifications in accordance with the relevant national procedures; (e) branches of social security referred to in Article 3 of Regulation (EC) No 883/2004; and (f) access to goods and services and the supply of goods and services made available to the public, including procedures for obtaining housing, as well as information and counselling services provided by employment offices. 2. With respect to paragraph 1, point (c), Member States may restrict equal treatment as regards study and maintenance grants and loans or other grants and loans regarding secondary and higher education and vocational training. Access to university and post-secondary education may be subject to specific prerequisites in accordance with national law. With respect to paragraph 1, point (f), Member States may restrict equal treatment as regards procedures for obtaining housing. This shall be without prejudice to the freedom of contract in accordance with Union and national law. 3. EU Blue Card holders moving to a third country, or their survivors who reside in a third country and who derive rights from an EU Blue Card holder, shall receive, in relation to old age, invalidity and death, statutory pensions based on the EU Blue Card holder\u2019s previous employment that were acquired in accordance with the legislation referred to in Article 3 of Regulation (EC) No 883/2004, under the same conditions and at the same rates as nationals of the Member States concerned where such nationals move to a third country. 4. The right to equal treatment laid down in paragraph 1 is without prejudice to the right of a Member State to withdraw or to refuse to renew the EU Blue Card in accordance with Article 8. 5. This Article does not apply to EU Blue Card holders who are beneficiaries of the right to free movement under Union law in the Member State concerned. 6. This Article applies to EU Blue Card holders who are beneficiaries of international protection only when they reside in a Member State other than the Member State which granted them international protection. 7. Where Member States issue national residence permits for the purpose of highly qualified employment, they shall grant EU Blue Card holders the same equal treatment rights as those granted to holders of national residence permits, where such equal treatment rights are more favourable than those provided for in this Article. Article 17 Family members 1. Directive 2003/86/EC applies, subject to the derogations laid down in this Article. 2. By way of derogation from Article 3(1) and Article 8 of Directive 2003/86/EC, family reunification shall not be made dependent on the EU Blue Card holder having reasonable prospects of obtaining the right of permanent residence, holding a residence permit for a period of validity of 1 year or more, or having a minimum period of residence. 3. By way of derogation from the third subparagraph of Article 4(1) and from the second subparagraph of Article 7(2) of Directive 2003/86/EC, the integration conditions and measures referred to therein may be applied, but only after the persons concerned have been granted family reunification. 4. By way of derogation from the first subparagraph of Article 5(4) of Directive 2003/86/EC, where the conditions for family reunification are fulfilled and the complete applications were submitted simultaneously, the decisions on the applications of family members shall be adopted and notified at the same time as the decision on the application for an EU Blue Card. Where the family members join the EU Blue Card holder after the EU Blue Card has been granted and where the conditions for family reunification are fulfilled, the decision shall be adopted and notified as soon as possible but not later than 90 days after the date of submission of the complete application. Article 11(2) and (3) of this Directive shall apply accordingly. 5. By way of derogation from Article 13(2) and (3) of Directive 2003/86/EC, the duration of validity of the residence permits of family members shall be the same as that of the EU Blue Card insofar as the period of validity of their travel documents allows it. 6. By way of derogation from Article 14(2) of Directive 2003/86/EC, Member States shall not apply any time limit in respect of access to the labour market for family members. By way of derogation from Article 14(1), point (b), of that Directive, and without prejudice to the restrictions referred to in Article 15(8) of this Directive, family members shall have access to any employment, and to self-employed activity in accordance with applicable requirements under national law, in the Member State concerned. 7. By way of derogation from Article 15(1) of Directive 2003/86/EC, for the purposes of calculation of the duration of residence required for the acquisition of an autonomous residence permit, residence in different Member States shall be cumulated. Member States may require 2 years of legal and continuous residence in the territory of the Member State where the application for the autonomous residence permit is submitted immediately prior to the submission of the relevant application. 8. This Article does not apply to family members of EU Blue Card holders who are beneficiaries of the right to free movement under Union law in the Member State concerned. 9. This Article applies to family members of EU Blue Card holders who are beneficiaries of international protection only when those EU Blue Card holders reside in a Member State other than the Member State which granted them international protection. 10. Where Member States issue national residence permits for the purpose of highly qualified employment, they shall grant EU Blue Card holders and their family members the same rights as those granted to holders of national residence permits and their family members where such rights are more favourable than those provided for in this Article. Article 18 EU long-term resident status for EU Blue Card holders 1. Directive 2003/109/EC applies, subject to the derogations laid down in this Article. 2. By way of derogation from Article 4(1) of Directive 2003/109/EC, an EU Blue Card holder who has made use of the possibility provided for in Article 21 of this Directive may cumulate periods of residence in different Member States in order to fulfil the requirement concerning the duration of residence, provided that the EU Blue Card holder has accumulated: (a) the number of years of legal and continuous residence required under Article 4(1) of Directive 2003/109/EC as a holder of an EU Blue Card, a national residence permit for highly qualified employment, an authorisation as researcher or, where appropriate, an authorisation as a student in accordance with the second subparagraph of Article 4(2) of Directive 2003/109/EC or as a beneficiary of international protection within the territory of the Member States; and (b) 2 years of legal and continuous residence as an EU Blue Card holder within the territory of the Member State where the application for EU long-term resident status is submitted immediately prior to the submission of the relevant application. 3. For the purpose of calculating the duration of legal and continuous residence in the Union referred to in paragraph 2, point (a), of this Article, and by way of derogation from the first subparagraph of Article 4(3) of Directive 2003/109/EC, periods of absence from the territory of the Member State concerned shall not interrupt the duration of legal and continuous residence in the Union if those periods of absence are shorter than 12 consecutive months and do not exceed in total 18 months within that duration. 4. By way of derogation from Article 9(1), point (c), of Directive 2003/109/EC, Member States shall extend to 24 consecutive months the period of absence from the territory of the Union during which an EU long-term resident who holds a long-term residence permit bearing the remark referred to in Article 19(2) of this Directive and his or her family members having been granted EU long-term resident status are allowed to be absent. 5. Article 16(1), point (f), Article 16(3), Article 20 and, where applicable, Articles 17 and 22 apply to holders of a long-term residence permit bearing the remark referred to in Article 19(2). 6. Where an EU long-term resident who holds a long-term residence permit bearing the remark referred to in Article 19(2) of this Directive exercises his or her right to move to a second Member State pursuant to Chapter III of Directive 2003/109/EC, Article 14(3) and (4) of that Directive shall not apply. The second Member State may apply measures in accordance with Article 21(8) of this Directive. Article 19 Long-term residence permit 1. Member States shall issue EU Blue Card holders who fulfil the conditions set out in Article 18 of this Directive for the acquisition of EU long-term resident status with a residence permit in accordance with Regulation (EC) No 1030/2002. 2. Member States shall enter the words \u2018Former EU Blue Card holder\u2019 in the residence permit referred to in paragraph 1 under the heading \u2018remarks\u2019. CHAPTER V MOBILITY BETWEEN MEMBER STATES Article 20 Short-term mobility 1. Where a third-country national who holds a valid EU Blue Card issued by a Member State that applies the Schengen acquis in full enters and stays in one or several second Member States for a period of 90 days in any 180-day period for the purpose of carrying out a business activity, the second Member State shall not require any authorisation for exercising such activity other than the EU Blue Card. 2. A third-country national who holds a valid EU Blue Card issued by a Member State that does not apply the Schengen acquis in full shall be entitled to enter and stay for the purpose of carrying out a business activity in one or several second Member States for up to 90 days in any 180-day period on the basis of the EU Blue Card and a valid travel document. Where the EU Blue Card holder crosses an internal border for which controls have not yet been lifted into a second Member State that applies the Schengen acquis in full, the second Member State may require the EU Blue Card holder to provide evidence of the business purpose of the stay. The second Member State shall not require any authorisation for exercising the business activity other than the EU Blue Card. Article 21 Long-term mobility 1. After 12 months of legal residence in the first Member State as an EU Blue Card holder, the third-country national shall be entitled to enter, reside and work in a second Member State for the purpose of highly qualified employment on the basis of the EU Blue Card and a valid travel document under the conditions set out in this Article. 2. Where the EU Blue Card is issued by a Member State that does not apply the Schengen acquis in full and the EU Blue Card holder crosses, for the purpose of long-term mobility, an internal border for which controls have not yet been lifted into a second Member State that applies the Schengen acquis in full, the second Member State may require the EU Blue Card holder to present the valid EU Blue Card issued by the first Member State and a work contract or a binding job offer for highly qualified employment for a period of at least 6 months in that second Member State. 3. As soon as possible and no later than 1 month after the EU Blue Card holder has entered the territory of the second Member State, an application for an EU Blue Card shall be submitted to the competent authority of that Member State. That application shall be accompanied by all the documents proving the fulfilment of the conditions referred to in paragraph 4 for the second Member State. Member States shall determine whether applications are to be made by the third-country national or by the employer. Alternatively, Member States may allow applications to be made by either of the two. The EU Blue Card holder shall be allowed to commence work in the second Member State not later than 30 days after the date of submission of the complete application. The application may be submitted to the competent authorities of the second Member State while the EU Blue Card holder is still residing in the territory of the first Member State. 4. For the purposes of an application as referred to in paragraph 3, the applicant shall present: (a) the valid EU Blue Card issued by the first Member State; (b) a valid work contract or, as provided for in national law, a binding job offer for highly qualified employment for a period of at least 6 months in the second Member State; (c) for regulated professions, documents attesting to the fulfilment of the conditions set under national law for the exercise by Union citizens of the regulated profession specified in the work contract or binding job offer as provided for in national law; (d) a valid travel document, as specified by national law; and (e) evidence of meeting the salary threshold set in the second Member State in application of Article 5(3) or, where applicable, of Article 5(4) or (5). With regard to point (c) of the first subparagraph, for the purpose of applying for an EU Blue Card in a second Member State, EU Blue Card holders shall enjoy equal treatment with Union citizens as regards recognition of professional qualifications, in accordance with applicable Union and national law. For unregulated professions, where the first Member State has issued an EU Blue Card on the basis of higher professional skills for occupations not listed in Annex I, the applicant may be required to present documents attesting to higher professional qualifications in relation to the work to be carried out, as provided for in the law of the second Member State. 5. For the purposes of an application as referred to in paragraph 3, the Member State concerned may require the applicant: (a) for unregulated professions, where the EU Blue Card holder has worked for less than 2 years in the first Member State, to present documents attesting to higher professional qualifications in relation to the work to be carried out, as provided for in national law; (b) to provide evidence of having, or if provided for by national law, having applied for, sickness insurance for all the risks normally covered for nationals of the Member State concerned for periods when no such insurance coverage or corresponding entitlement to benefits is provided for in connection with, or resulting from, the work contract. 6. The second Member State shall reject an application for an EU Blue Card where: (a) paragraph 4 is not complied with; (b) the documents presented have been fraudulently acquired, falsified or tampered with; (c) the employment does not comply with the conditions laid down under the applicable law, set in collective agreements or established by practices as referred to in Article 5(2); or (d) the EU Blue Card holder poses a threat to public policy, public security or public health. 7. In respect of any application procedure for the purpose of long-term mobility, the procedural safeguards set out in Article 11(2) and (3) shall apply accordingly. Without prejudice to paragraph 4 of this Article, a decision to reject an application for long-term mobility shall take account of the specific circumstances of the case and shall respect the principle of proportionality. 8. The second Member State may reject an application for an EU Blue Card on the basis of a check carried out in accordance with Article 7(2), point (a), only if that Member State carries out such checks when it is the first Member State. 9. The second Member State shall adopt either of the following decisions on an application for an EU Blue Card: (a) where the conditions for mobility laid down in this Article are fulfilled, to issue an EU Blue Card and allow the third-country national to reside in its territory for the purpose of highly qualified employment; or (b) where the conditions for mobility laid down in this Article are not fulfilled, to reject the application and require the applicant and his or her family members, in accordance with the procedures provided for in national law, to leave its territory. By way of derogation from Article 11(1), the second Member State shall notify the applicant and the first Member State of its decision in writing as soon as possible, but not later than 30 days after the date of submission of the complete application. Under exceptional and duly justified circumstances linked to the complexity of the application, a Member State may extend the deadline referred to in the second subparagraph by 30 days. It shall inform the applicant of the extension not later than 30 days after the date of submission of the complete application. In its notification to the first Member State, the second Member State shall specify any grounds referred to in paragraph 6, points (b) and (d), for rejecting the application. 10. Where the EU Blue Card issued by the first Member State expires during the application procedure, the second Member State may issue a national temporary residence permit, or an equivalent authorisation, that allows the applicant to continue to stay legally in its territory until a decision on the application has been taken by the competent authorities. 11. From the second time that an EU Blue Card holder and, where applicable, his or her family members make use of the possibility of moving to another Member State under this Article and Article 22, \u2018first Member State\u2019 shall be understood as meaning the Member State from where the person concerned moves and \u2018second Member State\u2019 shall be understood as meaning the Member State in which he or she is applying to reside. Notwithstanding paragraph 1 of this Article, an EU Blue Card holder may move to another Member State a second time after 6 months of legal residence in the first Member State as an EU Blue Card holder. Article 22 Residence in the second Member State for family members 1. Where an EU Blue Card holder moves to a second Member State in accordance with Article 21 and where the EU Blue Card holder\u2019s family was already constituted in the first Member State, the members of his or her family shall be entitled to accompany or join the EU Blue Card holder. Directive 2003/86/EC and Article 17 of this Directive apply in the cases referred to in the first subparagraph of this paragraph, subject to the derogations provided for in paragraphs 2 to 7 of this Article. Where the family was not already constituted in the first Member State, Article 17 of this Directive applies. 2. By way of derogation from Article 13(1) of Directive 2003/86/EC, the EU Blue Card holder\u2019s family members shall be entitled to enter and stay in the second Member State on the basis of the valid residence permits obtained in the first Member State as family members of an EU Blue Card holder. Where the residence permits of the family members are issued by a Member State that does not apply the Schengen acquis in full and those family members join the EU Blue Card holder when crossing an internal border for which controls have not yet been lifted for the purpose of moving to a second Member State that applies the Schengen acquis in full, the second Member State may require the family members to present the residence permits they obtained in the first Member State as family members of the EU Blue Card holder. 3. By way of derogation from Article 5(3) of Directive 2003/86/EC, no later than 1 month after entering the territory of the second Member State, the family members concerned or the EU Blue Card holder, in accordance with national law, shall submit an application for a residence permit as a family member to the competent authorities of that Member State. Where the residence permit of a family member issued by the first Member State expires during the procedure or no longer entitles the holder to reside legally in the second Member State, the second Member State shall allow the family member to stay in its territory until a decision on the application has been taken by the competent authorities of the second Member State, if necessary by issuing a national temporary residence permit or an equivalent authorisation. 4. By way of derogation from Article 5(2) and Article 7(1) of Directive 2003/86/EC, the second Member State may require the family members concerned to present or provide with their application for a residence permit: (a) their residence permit in the first Member State and a valid travel document, or certified copies thereof; (b) evidence that they have resided as members of the family of the EU Blue Card holder in the first Member State; (c) documentary evidence as referred to in Article 7(1), point (b), of Directive 2003/86/EC. 5. Where the conditions set out in this Article are fulfilled and the applications were submitted simultaneously, the second Member State shall issue the residence permits for family members at the same time as the EU Blue Card. By way of derogation from Article 17(4), where the conditions set out in this Article are fulfilled and the family members join the EU Blue Card holder after the EU Blue Card has been granted, residence permits for the family members shall be granted not later than 30 days after the date of submission of the complete application. In duly justified circumstances linked to the complexity of the application, Member States may extend the deadline referred to in the second subparagraph by a maximum of 30 days. 6. This Article applies to family members of EU Blue Card holders who are beneficiaries of international protection only when those EU Blue Card holders move to reside in a Member State other than the Member State which granted them international protection. 7. This Article does not apply to family members of EU Blue Card holders who are beneficiaries of the right to free movement under Union law in the second Member State. Article 23 Safeguards and sanctions in cases of mobility 1. Notwithstanding Article 8(1), point (a), and Article 8(2), point (a), where an EU Blue Card holder moves to another Member State under Article 21, the first Member State shall not withdraw the EU Blue Card before the second Member State has taken a decision on the application for long-term mobility. 2. Where the second Member State rejects the application for an EU Blue Card in accordance with Article 21(9), point (b), the first Member State shall, at the request of the second Member State, allow the re-entry of the EU Blue Card holder and, where applicable, of his or her family members, without formalities and without delay. This shall also apply if the EU Blue Card issued by the first Member State has expired or has been withdrawn during the examination of the application. 3. The EU Blue Card holder or the employer in the second Member State may be held liable for the costs related to the re-entry of the EU Blue Card holder and of his or her family members as referred to in paragraph 2. 4. Member States may provide for sanctions in accordance with Article 14 against an employer of an EU Blue Card holder, where that employer is responsible for a failure to comply with the conditions of mobility laid down in this Chapter. 5. Where a Member State withdraws or does not renew an EU Blue Card which bears the remark referred to in Article 9(5) and decides to expel the third-country national, it shall request the Member State indicated in that remark to confirm that the person concerned is still a beneficiary of international protection in that Member State. The Member State indicated in that remark shall reply within 1 month after receiving the request for information. Where the third-country national is still a beneficiary of international protection in the Member State indicated in that remark, that person shall be expelled to that Member State which shall, without prejudice to the applicable Union or national law and to the principle of family unity, immediately allow the re-entry, without formalities, of that person and his or her family members. By way of derogation from the second subparagraph of this paragraph, the Member State which adopted the expulsion decision shall retain the right to remove the third-country national, in accordance with its international obligations, to a country other than the Member State which granted international protection, where the conditions specified in Article 21(2) of Directive 2011/95/EU are fulfilled with respect to that third-country national. 6. Where an EU Blue Card holder or his or her family members cross the external border of a Member State that applies the Schengen acquis in full, that Member State shall consult the Schengen Information System in accordance with Regulation (EU) 2016/399. That Member State shall refuse entry for persons for whom an alert for the purposes of refusing entry and stay has been issued in the Schengen Information System. CHAPTER VI FINAL PROVISIONS Article 24 Access to information and monitoring 1. Member States shall make easily accessible to applicants for an EU Blue Card information on the documentary evidence needed for an application, as well as information on entry and residence conditions applicable to third-country nationals falling under the scope of this Directive and to their family members, including their rights and obligations and the procedural safeguards. That information shall include information on the salary thresholds set in the Member State concerned in accordance with Article 5(3), (4) and (5) and on the applicable fees. That information shall also include information on: (a) business activities in the territory of the Member State concerned in which an EU Blue Card holder from another Member State as referred to in Article 20 is allowed to engage; and (b) the procedures applicable to obtaining an EU Blue Card and residence permits for family members in a second Member State, as referred to in Articles 21 and 22. Where Member States decide to introduce legislative or regulatory measures in accordance with Article 6 or to make use of the possibility provided for by Article 7(2), point (a), they shall communicate information about such decisions in the same way. Information regarding any checks of the labour market situation pursuant to Article 7(2), point (a), shall specify, where appropriate, the sectors, occupations and regions concerned. 2. Where Member States issue national residence permits for the purpose of highly qualified employment, they shall ensure the same access to information on the EU Blue Card as is provided with respect to national residence permits. 3. Member States shall communicate the following information to the Commission at least once per year and whenever the information is modified: (a) the factor they have set for determining the annual salary thresholds in accordance with Article 5(3) or, where applicable, Article 5(4) or (5), and the resulting nominal amounts; (b) the list of the professions for which a lower salary threshold in accordance with Article 5(4) applies; (c) a list of allowed business activities, for the purposes of Article 20; (d) information on legislative or regulatory measures as referred to in Article 6, where applicable; (e) information regarding any checks of the labour market situation provided for in Article 7(2), point (a), where applicable. Where Member States reject applications for an EU Blue Card based on ethical recruitment considerations in accordance with Article 7(2), point (e), they shall communicate and justify such rejections to the Commission and to the other Member States each year with respect to the countries and professions concerned. Member States shall inform the Commission of agreements with third countries concluded in accordance with Article 7(2), point (e). Article 25 Statistics 1. By 18 November 2025, and annually thereafter, Member States shall, in accordance with Regulation (EC) No 862/2007 of the European Parliament and of the Council (25), communicate to the Commission statistics on the number of third-country nationals who were granted an EU Blue Card and those whose applications were rejected during the previous calendar year, specifying the applications that were considered inadmissible on grounds of Article 6 of this Directive or that were rejected under Article 7(2), point (a), of this Directive, as well as statistics on the numbers of third-country nationals whose EU Blue Card was renewed or withdrawn during the previous calendar year. Those statistics shall be disaggregated by citizenship, length of validity of permits, sex and age and, where available, by occupation, the size of the employer\u2019s undertaking and economic sector. The statistics on third-country nationals who have been granted an EU Blue Card shall be further disaggregated with respect to beneficiaries of international protection, beneficiaries of the right to free movement and those who have acquired EU long-term resident status in a Member State in accordance with Article 18 of this Directive. Statistics on admitted family members shall be communicated in the same manner, except as regards information on their occupation and the economic sector. For EU Blue Card holders and their family members who have been granted residence permits in a second Member State in accordance with Articles 21 and 22 of this Directive, the information provided shall, in addition, specify the Member State of previous residence. 2. For the purpose of the implementation of Article 5(3), (4) and (5) of this Directive, reference shall be made to data provided by Member States to Eurostat in accordance with Regulation (EU) No 549/2013 of the European Parliament and of the Council (26) and, where appropriate, to national data. Article 26 List of occupations in Annex I 1. The occupations for which the knowledge, skills and competences attested by a number of required years of relevant professional experience are considered equivalent to the knowledge, skills and competence attested by higher education qualifications for the purpose of applying for an EU Blue Card shall be listed in Annex I. 2. By 18 November 2026, and every 2 years thereafter, the Commission shall submit a report to the European Parliament and to the Council on its assessment of the list of occupations in Annex I, taking into account the changing needs of the labour market. Those reports shall be drawn up after consulting national authorities, on the basis of a public consultation which shall include the social partners. On the basis of those reports, if appropriate, the Commission may submit legislative proposals for the amendment of Annex I. Article 27 Reporting By 18 November 2026, and every 4 years thereafter, the Commission shall submit a report to the European Parliament and to the Council on the application of this Directive in the Member States. Those reports shall, in particular, assess the impact of Articles 5 and 13 and Chapter V. The Commission shall propose any amendments that it considers to be necessary. The Commission shall specifically assess the relevance of the salary threshold set in Article 5 and of the derogations provided for in that Article, taking into account, inter alia, the diversity of the economic, sectoral and geographical situations. Article 28 Cooperation between contact points 1. Member States shall appoint contact points which shall be responsible for receiving and transmitting the information needed to implement Articles 18, 20, 21 and 24 and shall cooperate effectively with each other. 2. The contact points referred to in paragraph 1 of this Article shall in particular cooperate effectively regarding validation arrangements with stakeholders in the education, training, employment and youth sectors, as well as in other relevant policy areas, needed to implement Article 5(1), point (b). 3. Member States shall ensure appropriate cooperation in the exchange of the information referred to in paragraph 1. Member States shall give preference to exchanging information via electronic means. Article 29 Amendment of Directive (EU) 2016/801 In Article 2(2) of Directive (EU) 2016/801, point (g) is replaced by the following: \u2018(g) who apply to reside in a Member State for the purpose of highly qualified employment within the meaning of Directive (EU) 2021/1883 of the European Parliament and of the Council (*1). Article 30 Repeal of Directive 2009/50/EC Directive 2009/50/EC is repealed with effect from 19 November 2023. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex II. Article 31 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 18 November 2023. They shall immediately communicate the text of those measures to the Commission. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive. Article 32 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 33 Addressees This Directive is addressed to the Member States in accordance with the Treaties. Done at Strasbourg, 20 October 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. LOGAR (1) OJ C 75, 10.3.2017, p. 75. (2) OJ C 185, 9.6.2017, p. 105. (3) Position of the European Parliament of 15 September 2021 (not yet published in the Official Journal) and decision of the Council of 7 October 2021. (4) Council Directive 2009/50/EC of 25 May 2009 on the conditions of entry and residence of third-country nationals for the purposes of highly qualified employment (OJ L 155, 18.6.2009, p. 17). (5) OJ C 58, 15.2.2018, p. 9. (6) Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin (OJ L 180, 19.7.2000, p. 22). (7) Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation (OJ L 303, 2.12.2000, p. 16). (8) Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted (OJ L 337, 20.12.2011, p. 9). (9) Council Directive 2003/86/EC of 22 September 2003 on the right to family reunification (OJ L 251, 3.10.2003, p. 12). (10) Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77). (11) Directive (EU) 2016/801 of the European Parliament and of the Council of 11 May 2016 on the conditions of entry and residence of third-country nationals for the purposes of research, studies, training, voluntary service, pupil exchange schemes or educational projects and au pairing (OJ L 132, 21.5.2016, p. 21). (12) Directive 2014/66/EU of the European Parliament and of the Council of 15 May 2014 on the conditions of entry and residence of third-country nationals in the framework of an intra-corporate transfer (OJ L 157, 27.5.2014, p. 1). (13) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). (14) Council Regulation (EC) No 1030/2002 of 13 June 2002 laying down a uniform format for residence permits for third-country nationals (OJ L 157, 15.6.2002, p. 1). (15) Council Directive 2003/109/EC of 25 November 2003 concerning the status of third-country nationals who are long-term residents (OJ L 16, 23.1.2004, p. 44). (16) Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ L 166, 30.4.2004, p. 1). (17) Regulation (EU) No 1231/2010 of the European Parliament and of the Council of 24 November 2010 extending Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 to nationals of third countries who are not already covered by these Regulations solely on the ground of their nationality (OJ L 344, 29.12.2010, p. 1). (18) Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22). (19) Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (OJ L 18, 21.1.1997, p. 1). (20) Directive 2014/67/EU of the European Parliament and of the Council of 15 May 2014 on the enforcement of Directive 96/71/EC concerning the posting of workers in the framework of the provision of services and amending Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System (\u2018the IMI Regulation\u2019) (OJ L 159, 28.5.2014, p. 11). (21) Regulation (EC) No 1987/2006 of the European Parliament and of the Council of 20 December 2006 on the establishment, operation and use of the second generation Schengen Information System (SIS II) (OJ L 381, 28.12.2006, p. 4). (22) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (23) Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof (OJ L 212, 7.8.2001, p. 12). (24) Directive 2009/52/EC of the European Parliament and of the Council of 18 June 2009 providing for minimum standards on sanctions and measures against employers of illegally staying third-country nationals (OJ L 168, 30.6.2009, p. 24). (25) Regulation (EC) No 862/2007 of the European Parliament and of the Council of 11 July 2007 on Community statistics on migration and international protection and repealing Council Regulation (EEC) No 311/76 on the compilation of statistics on foreign workers (OJ L 199, 31.7.2007, p. 23). (26) Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union (OJ L 174, 26.6.2013, p. 1). ANNEX I List of occupations referred to in Article 2, point (9) Information and communications technology managers and professionals who have acquired at least 3 years of relevant professional experience within 7 years prior to the application for an EU Blue Card belonging to the following groups of the ISCO-08 classification: (1) 133 Information and Communications Technology Services Managers; (2) 25 Information and Communications Technology Professionals. ANNEX II CORRELATION TABLE Directive 2009/50/EC This Directive Article 1 Article 1 Article 2(a) Article 2, point (1) Article 2(b) Article 2, point (2) Article 2(c) Article 2, point (3) Article 2(d) Article 2, point (4) Article 2(e) Article 2, point (5) Article 2(f) Article 2, point (6) Article 2(g) Article 2, points (7) and (9) Article 2(h) Article 2, point (8) Article 2(i) Article 2, point (10) Article 2(j) Article 2, point (11) - Article 2, point (12) - Article 2, point (13) - Article 2, point (14) Article 3(1) Article 3(1) Article 3(2), introductory wording Article 3(2), introductory wording Article 3(2)(a) Article 3(2), point (a) Article 3(2)(b) - Article 3(2)(c) Article 3(2), point (b) Article 3(2)(d) Article 3(2), point (c) Article 3(2)(e) - Article 3(2)(f) Article 3(2), point (d) Article 3(2)(g) Article 3(2), point (e) Article 3(2)(h) - Article 3(2)(i) Article 3(2), point (f) Article 3(2)(j) Article 3(2), point (g) Article 3(2), last subparagraph Article 3(2), point (h) Article 3(3) Article 7(2), point (e) Article 3(4) Article 3(3) Article 4(1), introductory wording Article 4(1), introductory wording Article 4(1)(a) Article 4(1), point (a) Article 4(1)(b) Article 4(1), point (b) Article 4(2) Article 4(2) Article 5(1), introductory wording Article 5(1), introductory wording Article 5(1)(a) Article 5(1), point (a) Article 5(1)(b) Article 5(1), point (c) Article 5(1)(c) Article 5(1), point (b) Article 5(1)(d) Article 5(1), point (d) Article 5(1)(e) Article 5(1), point (e) Article 5(1)(f) Article 7(1), point (c) Article 5(2) Article 5(7), first subparagraph Article 5(3) Article 5(3) Article 5(4) Article 5(2) Article 5(5) Article 5(4) - Article 5(5) - Article 5(6) - Article 5(7), second subparagraph Article 5(6) - Article 6 Article 6 Article 7(1) Article 9(1) Article 7(2) Article 9(2) Article 7(3) Article 9(3) Article 7(4) Article 9(7) - Article 9(4) - Article 9(5) - Article 9(6) Article 8(1) Article 7(1), points (a) and (b) - Article 7(1), point (d) Article 8(2) Article 7(2), point (a) Article 8(3) - Article 8(4) Article 7(2), point (e) Article 8(5) Article 7(2), point (d) - Article 7(2), point (b) - Article 7(2), point (c) - Article 7(3) Article 9(1), introductory wording Article 8(1), introductory wording Article 9(1)(a) Article 8(1), point (a) Article 9(1)(b) Article 8(1), points (b), (c) and (d); Article 8(2), points (d), (e) and (g) Article 9(1)(c) Article 8(2), point (f) Article 9(2) Article 8(3) Article 9(3), introductory wording Article 8(2), introductory wording Article 9(3)(a) Article 8(2), point (a) - Article 8(2), point (b) Article 9(3)(b) Article 8(2), point (c) Article 9(3)(c) - Article 9(3)(d) - - Article 8(2), point (h) - Article 8(4) - Article 8(6) - Article 8(7) Article 10(1) Article 10(1) Article 10(2) Article 10(2) Article 10(3) Article 10(3) Article 10(4) - Article 11(1), first subparagraph Article 11(1), first subparagraph Article 11(1), second subparagraph - - Article 11(1), second subparagraph Article 11(2) Article 11(2) Article 11(3) Article 11(3) - Article 11(4) - Article 11(5) - Article 11(6) - Article 12 - Article 13 - Article 14 Article 12(1) - - Article 15(1) Article 12(2) Article 15(2) and (3) Article 12(3) and (4) Article 15(8) Article 12(5) Article 15(9) - Article 15(5), (6) and (7) Article 13(1) Article 8(5) Article 13(2) and (4) Article 15(4) Article 13(3) - Article 14(1), introductory wording Article 16(1), introductory wording Article 14(1)(a) Article 16(1), point (a) Article 14(1)(b) Article 16(1), point (b) Article 14(1)(c) Article 16(1), point (c) Article 14(1)(d) Article 16(1), point (d) Article 14(1)(e) Article 16(1), point (e) Article 14(1)(f) Article 16(3) Article 14(1)(g) Article 16(1), point (f) Article 14(1)(h) - Article 14(2), introductory wording, letter (a), and last subparagraph Article 16(2) Article 14(2)(b) - Article 14(3) Article 16(4) Article 14(4) - - Article 16(5), (6) and (7) Article 15(1) Article 17(1) Article 15(2) Article 17(2) Article 15(3) Article 17(3) Article 15(4) Article 17(4) Article 15(5) Article 17(5) Article 15(6) Article 17(6) Article 15(7) Article 17(7) Article 15(8) - - Article 17(8), (9) and (10) Article 16(1) Article 18(1) Article 16(2) Article 18(2) Article 16(3) Article 18(3) Article 16(4) Article 18(4) Article 16(5) - Article 16(6) Article 18(5) - Article 18(6) Article 17(1) Article 19(1) Article 17(2) Article 19(2) - Article 20 Article 18(1) Article 21(1) - Article 21(2) Article 18(2) Article 21(3), first two subparagraphs Article 18(3) Article 21(3), third subparagraph Article 18(4) Article 21(9) and Article 23(2) Article 18(5) Article 21(10) Article 18(6) Article 23(3) Article 18(7) - Article 18(8) Article 21(11) - Article 21(4) to (8) Article 19(1) Article 22(1), first subparagraph - Article 22(2) Article 19(2) Article 22(3) Article 19(3) Article 22(4) Article 19(4) - Article 19(5) Article 22(1), second subparagraph Article 19(6) Article 22(1), third subparagraph - Article 22(5), (6) and (7) - Article 23(1), (4), (5) and (6) - Article 24(1), first and second subparagraph Article 20(1) Article 24(1), third subparagraph - Article 24(2) and (3) Article 20(2) Article 25(1) Article 20(3) Article 25(2) - Article 26 Article 21 Article 27 Article 22(1) Article 28(1) - Article 28(2) Article 22(2) Article 28(3) - Article 29 - Article 30 Article 23 Article 31 Article 24 Article 32 Article 25 Article 33", "summary": "EU blue card \u2013 entry and residence of highly qualified workers (from 2023) EU blue card \u2013 entry and residence of highly qualified workers (from 2023) SUMMARY OF: Directive (EU) 2021/1883 \u2013 conditions of entry to and residence in the European Union of non-EU nationals for the purpose of highly qualified employment WHAT IS THE AIM OF THE DIRECTIVE? The directive lays down the entry and residence conditions for and rights of highly qualified third-country* nationals and their families: staying for more than 3 months in a European Union (EU) Member State; working in a Member State other than the one that first granted them an EU blue card. KEY POINTS The directive\u2019s scope is the following. It applies to non-EU nationals applying, or having applied, for highly qualified employment in a Member State. It does not apply to non-EU nationals: seeking international protection;carrying out a research project;who are granted long-term resident status in a Member State;who are covered by an international agreement allowing a temporary stay, rights of free movement or whose expulsion has been suspended. It does not affect: more favourable rules in EU law, including bilateral and multilateral agreements;the right of Member States to decide how many non-EU nationals may enter their territory. Applicants for an EU blue card must present: a valid work contract or a binding job offer for highly qualified employment for at least 6 months; documents confirming their professional qualifications; valid travel, and where required visa, documents; evidence of having applied for health insurance if this is not covered in the contract. Member States: require that conditions under relevant national law, collective agreements or established practices are met; ensure the salary threshold they set is at least equal to, but no higher than 1.6 times, the average gross national annual salary, a lower threshold of 80% applying to professions with shortages and recent non-EU graduates (no more than 3 years); decide whether applications are made by the non-EU national, the employer or either of the two; may charge fees, as long as they are not disproportionate or excessive, for handling applications; make easily accessible to applicants all the documentary evidence required and the attached conditions; appoint contact points to receive and transmit information. Rejection rules stipulate the following. Member States must reject applications where the: admission criteria are not complied with;documents presented are false;applicant is considered a threat to public policy, security or health;main purpose of the employer\u2019s business is to bring in non-EU nationals. Member States may reject applications where the: vacancy may be filled by a national, EU citizen or third-country citizen legally living in the EU;employer has not met tax and other legal obligations, is bankrupt, is facing insolvency or has illegally employed non-EU nationals;applicant\u2019s home country has a lack of qualified workers in the profession concerned. Withdrawal or non-renewal rules stipulate the following. Member States must withdraw or refuse to renew a blue card where: the card or documents are false;a non-EU national no longer has a valid work contract or the necessary qualifications, or no longer meets the salary threshold. Member States may withdraw or refuse to renew a blue card where: public policy, security or health are at risk;the employer has failed to meet their legal obligations;the blue card holder does not comply with the directive\u2019s personal finance, residence and other requirements. Blue cards: are valid for at least 24 months, or, if a work contract is for a shorter period, a further 3 months after the contract ends; entitle holders to enter, re-enter and stay in the Member State and enjoy all the rights under the directive. Employers: benefit from a simplified blue card procedure if a Member State gives them recognised status; face effective, proportionate and dissuasive national sanctions if they do not comply with the legislation. EU blue card holders: may have to inform national authorities of any change of employer or circumstances during the first 12 months of legal employment; enjoy equal treatment to EU nationals in areas such as employment conditions, freedom of association, educational and vocational training, mutual recognition of diplomas, social security and access to goods and services; can be accompanied by their family members, who also have the right to work; may acquire long-term EU resident status, subject to certain conditions; may, after living legally for 12 months in the Member State that issued the blue card, move, live and work with their family in another Member State. The directive requires the following. Member States must provide by 18 November 2025, and annually thereafter, detailed statistics on blue cards granted, refused and withdrawn and the reasons given. The European Commission must submit reports to the European Parliament and the Council of the European Union by 18 November 2026 on its assessment of the: list of highly skilled occupations in Annex I, and do so every 2 years thereafter taking account of changing needs in the labour market;application of the directive, proposing amendments if necessary, and to do so every 4 years. The directive: amends Directive (EU) 2016/801 on the entry and residence of non-EU nationals for research, studies, training, voluntary service, secondary education and au pairing (see summary); repeals the original blue card directive, Directive 2009/50/EC (see summary), as of 19 November 2023. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 17 November 2021 and has to become law in the Member States by 18 November 2023. BACKGROUND The directive updates previous blue card rules. It gives the EU a targeted legal migration scheme that can respond to skill shortages and makes it easier for highly skilled professionals to join the workforce. The directive provides an EU framework for attracting talent, while individual Member States decide how many people to admit to their labour market. For further information, see: Blue card \u2013 EU immigration portal (European Commission)EU blue card: Commission welcomes political agreement on new rules for highly skilled migrant workers \u2013 press release (European Commission). KEY TERMS Third-country national. Any person who is not a citizen of the EU. MAIN DOCUMENT Directive (EU) 2021/1883 of the European Parliament and of the Council of 20 October 2021 on the conditions of entry and residence of third-country nationals for the purpose of highly qualified employment, and repealing Council Directive 2009/50/EC (OJ L 382, 28.10.2021, pp. 1\u201338). RELATED DOCUMENTS Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on a New Pact on Migration and Asylum (COM(2020) 609 final, 23.9.2020). Directive (EU) 2016/801 of the European Parliament and of the Council of 11 May 2016 on the conditions of entry and residence of third-country nationals for the purposes of research, studies, training, voluntary service, pupil exchange schemes or educational projects and au pairing (OJ L 132, 21.5.2016, pp. 21\u201357). Successive amendments to Directive (EU) 2016/801 have been incorporated in the original text. This consolidated version is of documentary value only. Council Directive 2009/50/EC of 25 May 2009 on the conditions of entry and residence of third-country nationals for the purposes of highly qualified employment (OJ L 155, 18.6.2009, pp. 17\u201329). last update 16.12.2021"}
{"article": "15.7.2021 EN Official Journal of the European Union L 251/1 REGULATION (EU) 2021/1147 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2021 establishing the Asylum, Migration and Integration Fund THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 78(2) and Article 79(2) and (4) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) In the context of the evolving migratory challenges characterised by the need to support strong reception, asylum, integration and migration systems in the Member States, to prevent and adequately handle situations of pressure in solidarity, and to replace irregular and unsafe arrivals with legal and safe pathways, investing in efficient and coordinated migration management in the Union is key to realising the Union\u2019s objective of constituting an area of freedom, security and justice in accordance with Article 67(2) of the Treaty on the Functioning of the European Union (TFEU). (2) The importance of a coordinated approach by the Union and the Member States is reflected in the European Agenda on Migration of 13 May 2015, which stressed the need for a consistent and clear common policy in order to restore confidence in the Union\u2019s ability to bring together European and national efforts to address migration and to work together in an effective way, in accordance with the principle of solidarity and fair sharing of responsibility between the Member States as set out in Article 80 TFEU; this was confirmed in the mid-term review of 27 September 2017 and the progress reports of 14 March 2018 and 16 May 2018. (3) In its conclusions of 19 October 2017, the European Council reaffirmed the need to pursue a comprehensive, pragmatic and resolute approach to migration management that aims to ensure control of external borders and reduce irregular arrivals and the number of deaths at sea; that approach should be based on the flexible and coordinated use of all available Union and Member State instruments. The European Council further called for the ensuring of significantly enhanced returns through actions at both Union and Member State level, such as effective readmission agreements and arrangements. (4) In order to support efforts to ensure a comprehensive approach to the management of migration that is grounded on mutual trust, solidarity and fair sharing of responsibility among Member States and Union institutions, with the objective of ensuring a common sustainable Union policy on asylum and immigration, Member States should be supported by adequate financial resources in the form of an Asylum, Migration and Integration Fund (the \u2018Fund\u2019). (5) All actions funded under the Fund, including those carried out in third countries, should be implemented in full compliance with the rights and principles enshrined in the Union acquis and the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019), and should be in line with the international obligations of the Union and the Member States arising from the international instruments to which they are party, in particular by ensuring compliance with the principles of gender equality, non-discrimination and the best interests of the child. (6) The best interests of the child should be a primary consideration in all actions or decisions concerning children in migration, including returns, taking full account of the right of the child to express his or her views. (7) The Fund should build on the results achieved and investments made with the support of its predecessors: the European Refugee Fund established by Decision No 573/2007/EC of the European Parliament and of the Council (4) for the period 2008-2013, the European Fund for the Integration of third-country nationals established by Council Decision 2007/435/EC (5) for the period 2007-2013, the European Return Fund established by Decision No 575/2007/EC of the European Parliament and of the Council (6) for the period 2008-2013 and the Asylum, Migration and Integration Fund established by Regulation (EU) No 516/2014 of the European Parliament and of the Council (7) for the period 2014-2020. It should at the same time take into account all relevant new developments. (8) The Fund should support solidarity and fair sharing of responsibility between Member States and the efficient management of migration flows, inter alia, by promoting common measures in the area of asylum, including Member States\u2019 efforts in receiving persons in need of international protection through resettlement and humanitarian admission and the transfer between Member States of applicants for international protection or beneficiaries of international protection, by enhancing the protection of vulnerable asylum seekers such as children, by supporting integration strategies and by developing and strengthening legal migration policy, for example, through the provision of safe and legal avenues of entry to the Union, which should also help to ensure the Union\u2019s long-term competitiveness and the future of its social model and reduce incentives for irregular migration through a sustainable return and readmission policy. (9) Given the internal nature of the Fund and that the Fund is the main funding instrument for asylum and migration at Union level, the Fund should primarily support actions serving internal Union policy on asylum and migration in line with the Fund\u2019s objectives. However, given that certain actions taken outside the Union contribute to the achievement of the Fund\u2019s objectives and, under certain circumstances, may bring Union added value, the Fund should support the strengthening of cooperation and partnership with third countries for the purpose of managing migration in order to reinforce avenues of legal migration and enhance effective, safe and dignified return and readmission, as well as to promote initial reintegration in third countries. Support provided under the Fund would be without prejudice to the current voluntary nature of resettlement and relocation of applicants for international protection and beneficiaries of international protection under the legal framework of the Common European Asylum System that applies at the time of adoption of this Regulation. (10) In order to benefit from the expertise of relevant decentralised agencies, the Commission should ensure that their knowledge and experience is taken into account as regards the areas of their competence in the development of Member States\u2019 programmes. Furthermore, it should be possible for the Fund to complement the following activities supported by the European Asylum Support Office (EASO), established by Regulation (EU) No 439/2010 of the European Parliament and of the Council (8), with a view to facilitating and improving the functioning of the Common European Asylum System: strengthening practical cooperation, in particular information exchanges regarding asylum and good practices; promoting Union and international law and contributing to the uniform implementation of Union law on asylum on the basis of high standards for international protection procedures, for reception conditions and for the assessment of protection needs across the Union; enabling the sustainable and fair distribution of applications for international protection; facilitating convergence in the assessment of applications for international protection across the Union; supporting the resettlement efforts of the Member States; and providing operational and technical assistance to Member States for the management of their asylum and reception systems, in particular those whose systems are subject to disproportionate pressure. (11) The Fund should support the efforts of the Union and the Member States to enhance the Member States\u2019 capacity to develop, monitor and evaluate their asylum policies in the light of their obligations under Union law. (12) The Fund should support the Member States\u2019 and the Union\u2019s efforts to fully implement and further develop the Common European Asylum System, including its external dimension. (13) Partnerships and cooperation with third countries are an essential component of Union policy for managing migration. The Fund should contribute to replacing unsafe and irregular arrival with legal and safe arrival in the territory of the Member States of third-country nationals or stateless persons in need of international protection, expressing solidarity with countries in regions to which or within which a large number of persons in need of international protection have been displaced by helping to alleviate the pressure on those countries, and should effectively contribute to global resettlement initiatives with the Union and Member States speaking with one voice in international fora and with third countries. The Fund should provide support, in the form of financial incentives, to efforts made by Member States to provide international protection and a durable solution for refugees and displaced persons who have been admitted under resettlement or humanitarian admission programmes. (14) Considering the migration flows to the Union and the importance of ensuring integration and inclusion for persons coming to Europe for local communities and for the long-term well-being of our societies and the stability of our economies, it is crucial to support Member States\u2019 policies for the integration of legally-staying third-country nationals, including in the priority areas identified in the Action Plan on Integration and Inclusion 2021-2027. The Fund should support integration measures that are tailored to the needs of third-country nationals, as well as horizontal measures aimed at building Member States\u2019 capacity to develop integration strategies, to strengthen exchange and cooperation, and to promote contact, constructive dialogue and acceptance between third-country nationals and the receiving society. (15) In order to increase efficiency, to achieve the greatest Union added value and to ensure the consistency of the Union\u2019s response in terms of fostering the integration of third-country nationals, actions financed under the Fund should be consistent with and complementary to actions financed under other Union instruments, in particular external instruments, the European Social Fund Plus (ESF+), established by Regulation (EU) 2021/1057 of the European Parliament and of the Council (9), and the European Regional Development Fund (ERDF), established by Regulation (EU) 2021/1058 of the European Parliament and of the Council (10). The Fund should support measures tailored to the needs of third-country nationals that are generally implemented in the early stages of integration, as well as horizontal measures supporting Member States\u2019 capacities in the field of integration, whereas interventions for third-country nationals with a longer-term impact should be financed under the ESF+ and ERDF. In this context, the authorities of the Member States responsible for the implementation of the Fund should be required to cooperate and coordinate with the authorities identified by Member States for the purpose of the management of the interventions of the ESF+ and the ERDF and, wherever necessary, to cooperate and coordinate with their managing authorities and with the managing authorities of other Union funds contributing to the integration of third-country nationals. (16) The scope of the integration measures should also cover beneficiaries of international protection in order to ensure a comprehensive approach to integration, taking into account the specificities of that target group. Where integration measures are combined with reception, actions should, where appropriate, also allow asylum seekers to be included. (17) The implementation of the Fund in the area of integration should be consistent with the Union\u2019s common basic principles on integration, as specified in the Action Plan on Integration and Inclusion 2021-2027. (18) It should be possible for those Member States that so wish to provide in their programmes for integration measures to include immediate relatives of third-country nationals, thus supporting family unity, to the extent that doing so is necessary for the effective implementation of such measures. The term \u2018immediate relative\u2019 should be understood as meaning spouses, partners and any person having direct family links in the descending or ascending line with the third-country national targeted by the integration measure and who would not otherwise be covered by the scope of the Fund. (19) Considering the crucial role played by Member States\u2019 authorities and civil society organisations in the field of integration, and in order to facilitate the access of those entities to funding at Union level, the Fund should facilitate the implementation of actions in the field of integration by national, regional and local authorities and civil society organisations, including through the use of the thematic facility and through a higher co-financing rate for those actions. In that regard, a minimum of 5 % of the initial allocation to the thematic facility should target the implementation of integration measures by local and regional authorities. (20) In addition to the co-financing rate provided by the Fund for projects, Member States are encouraged to provide funding from the budgets of their public authorities where such funding is essential for a project to be carried out, particularly when the project is implemented by a civil society organisation. (21) Considering the long-term economic and demographic challenges faced by the Union and the increasingly globalised nature of migration, it is crucial to establish well-functioning channels for legal migration to the Union in order to maintain the Union as an attractive destination for regular migration, in accordance with Member States\u2019 economic and social needs, and to ensure the sustainability of welfare systems and growth of the Union economy, while protecting migrant workers from labour exploitation. (22) The Fund should support Member States in setting up strategies and strengthening and developing policies for legal migration, and in enhancing their capacity to develop, implement, monitor and evaluate immigration and integration strategies, policies and measures for legally staying third-country nationals, in particular Union legal instruments for legal migration. The Fund should also support the exchange of information, best practices and cooperation between different administrative departments and levels of government, and between Member States. (23) An efficient and dignified return policy is an integral part of the comprehensive migration approach pursued by the Union and its Member States. The Fund should support and encourage efforts by Member States with a view to the effective implementation and further development of common standards on return, in particular as set out in Directive 2008/115/EC of the European Parliament and of the Council (11), with an emphasis on voluntary returns, and of an integrated and coordinated approach to return management. For sustainable return policies, the Fund should equally support related measures in third countries, such as measures to facilitate and guarantee safe and dignified return and readmission and sustainable reintegration of returnees, including through the provision of cash or in-kind support. (24) Member States should give preference to voluntary return and should ensure effective, safe and dignified return. In order to promote voluntary return, Member States should envisage incentives such as preferential treatment in the form of enhanced return assistance and initial reintegration support. That kind of voluntary return is in the interest of both returnees and authorities in terms of its cost-effectiveness. (25) While voluntary return should take priority over forced return, they are nevertheless interlinked, with a mutually reinforcing effect, and Member States should therefore be encouraged to reinforce the complementarities between those two forms of return. The possibility of removals is an important element that contributes to the integrity of the asylum and legal migration systems. The Fund should therefore support actions by Member States to facilitate and carry out removals in accordance with standards laid down in Union law, where applicable, and with full respect for the fundamental rights and dignity of returnees. (26) Specific support measures for returnees, with particular attention to their humanitarian and protection needs in the Member States and in the countries of return, can improve conditions of return and enhance the reintegration of returnees. Particular attention should be paid to vulnerable persons. (27) Effective readmission of illegally staying third-country nationals by third countries is an integral component of the Union return policy and a central tool for the efficient management of migration flows, as it facilitates the swift return of irregular migrants. Readmission cooperation is an important element in the framework of dialogue and cooperation with third countries of origin and the transit of irregular migrants, and its implementation in third countries should be supported in the interests of effective return policies at national and Union level. (28) In addition to supporting the return of persons as provided for in this Regulation, the Fund should also support other measures to counter irregular migration and the trafficking of migrants and to encourage compliance with legal migration rules, thereby safeguarding the integrity of Member States\u2019 immigration systems. (29) The employment of irregular migrants undermines the development of a labour mobility policy built on legal migration schemes and endangers the rights of migrant workers, making them vulnerable to rights violations and abuse. The Fund should therefore support Member States, either directly or indirectly, in their implementation of Directive 2009/52/EC of the European Parliament and of the Council (12), which prohibits the employment of illegally staying third-country nationals and provides for sanctions against employers who infringe that prohibition. (30) The Fund should support Member States, either directly or indirectly, in their implementation of Directive 2011/36/EU of the European Parliament and of the Council (13), which sets out provisions on assistance, support and protection for victims of trafficking in human beings. Those measures, including measures for the early identification of victims of trafficking in human beings and their referral to specialised services, should take into account the gender-specific nature of trafficking in human beings and child victims. (31) The Fund should complement the activities undertaken in the field of return by the European Border and Coast Guard Agency, governed by Regulation (EU) 2019/1896 of the European Parliament and of the Council (14), without providing an additional funding stream to that Agency. (32) In keeping with the principle of efficiency, synergies and consistency should be sought with other Union funds, and overlap between actions should be avoided. (33) In order to optimise the added value from investments funded wholly or in part through the Union budget, synergies should be sought, in particular, between the Fund and other Union programmes, including those under shared management. To maximise those synergies, key enabling mechanisms should be ensured, including cumulative funding for an action from the Fund and from another Union programme. Such cumulative funding should not exceed the total eligible costs of that action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility of declaring the same cost or expenditure under both the Fund and another Union programme on a pro-rata basis. (34) Actions in and in relation to third countries supported under the Fund should be carried out in synergy and coherence with other activities outside the Union supported through the Union\u2019s external financing instruments. In particular, in implementing such actions, full coherence should be sought with the principles and general objectives of external Union policy, with the principle of policy coherence for development and consistency with the strategic programming documents for the country or region in question, and with the Union\u2019s international commitments. In relation to the external dimension, the Fund should focus on supporting actions that are not development-oriented and that serve the interest of internal Union policies and should be consistent with activities undertaken within the Union. The Fund should target support to enhance cooperation with third countries and to reinforce key aspects of migration management in areas of interest to the Union\u2019s migration policy. (35) Funding from the Union budget should concentrate on actions for which Union intervention can bring added value compared to actions by Member States alone. Financial support provided under this Regulation should contribute, in particular, to strengthening national and Union capabilities in the areas of asylum and migration in accordance with Article 80 TFEU. (36) When promoting actions supported by the Fund, the recipients of Union funding should provide information in the language or languages of the target audience. To ensure the visibility of Union funding, recipients of that funding should refer to its origin when communicating on the action. To that end, recipients should ensure that all communications to the media and the public display the Union emblem and explicitly mention the Union\u2019s financial support. (37) It should be possible for the Commission to use financial resources under the Fund to promote best practices and the exchange of information as regards the implementation of the Fund. (38) The Commission should publish information on the support provided from the thematic facility under direct or indirect management in a timely manner and should update such information where appropriate. It should be possible to sort the data by specific objective, name of beneficiary, the amount legally committed and the nature and purpose of the measure. (39) A Member State may be deemed not to be compliant with the relevant Union acquis, including as regards the use of operating support under the Fund, if it has failed to fulfil its obligations under the Treaties in the area of asylum and return, if there is a clear risk of a serious breach by that Member State of Union values when implementing the acquis on asylum and return, or if an evaluation report under the Schengen evaluation and monitoring mechanism laid down in Council Regulation (EU) No 1053/2013 (15) has identified deficiencies in the relevant area. (40) The Fund should ensure that there is a fair and transparent distribution of resources to meet the objectives laid down in this Regulation. In order to meet transparency requirements, the Commission should publish information on the annual and multiannual work programmes of the thematic facility. In line with Regulation (EU) 2021/1060 of the European Parliament and of the Council (16), each Member State should ensure that within six months of the approval of its programme, there is a website in place on which information on its programme is available, covering the programme\u2019s objectives, activities, available funding opportunities and achievements. (41) This Regulation should establish the initial amounts for Member States\u2019 programmes which consist of a fixed amount as set out in Annex I and an amount calculated on the basis of the criteria laid down in that Annex and which reflect the needs and pressure experienced by different Member States in the areas of asylum, migration, integration and return. In view of the special needs of those Member States which have experienced the highest number of asylum applications per capita in 2018 and 2019, it is appropriate to increase the fixed amounts for Cyprus, Malta and Greece. (42) The initial amounts for Member States\u2019 programmes should form the basis for Member States\u2019 long-term investments. To take account of changes in migration flows, to address needs in respect of the management of asylum and reception systems and in respect of the integration of legally staying third-country nationals, and to develop legal migration and counter irregular migration through effective, safe and dignified return, an additional amount should be allocated to the Member States at the mid-term of the programming period taking into account objective criteria. That amount should be based on statistical data, in accordance with Annex I, to reflect the changes in the baseline situation of Member States. (43) To contribute to the achievement of the policy objective of the Fund, Member States should ensure that their programmes include actions addressing the specific objectives of the Fund, that the priorities chosen are in accordance with the implementation measures set out in Annex II, and that the allocation of resources between the objectives ensures that the overall policy objective can be met. To that end, Member States should, in principle, ensure a minimum allocation for strengthening and developing the Common European Asylum System, for strengthening and developing legal migration to the Member States in accordance with their economic and social needs, and for promoting and contributing to the effective integration and social inclusion of third-country nationals. (44) As challenges in the area of migration are constantly evolving, there is a need to adapt the allocation of funding to the changes in migration flows. To respond to pressing needs and changes in policy and Union priorities, and to steer funding towards actions with a high level of Union added value, part of the funding should be periodically allocated, via a thematic facility, to specific actions, to Union actions, to actions of local and regional authorities, to emergency assistance, to resettlement and humanitarian admission, and to additional support for Member States contributing to solidarity and responsibility efforts. The thematic facility offers flexibility in the management of the Fund and could also be implemented through Member States\u2019 programmes. (45) Member States should be encouraged to use part of their programme allocation to fund the actions listed in Annex IV by benefiting from a greater Union contribution. (46) Part of the available resources under the Fund could be allocated to Member States\u2019 programmes for the implementation of specific actions, in addition to the initial allocation. Those specific actions should be identified at Union level and should concern actions which require cooperation or actions necessary to address developments in the Union which require additional funding to be made available to one or more Member States. (47) The Fund should contribute to supporting operating costs that relate to the specific objectives of the Fund in order to enable Member States to maintain capabilities which are crucial for tasks and services which constitute a public service for the Union as a whole. Such support should consist of the full reimbursement of specific costs that relate to the objectives of the Fund and should form an integral part of the Member States\u2019 programmes. (48) To complement the implementation of the policy objective of the Fund at national level through Member States\u2019 programmes, the Fund should also provide support for actions at Union level. Such actions should serve overall strategic purposes within the scope of intervention of the Fund in relation to policy analysis and innovation, transnational mutual learning and partnerships, and the testing of new initiatives and actions across the Union. (49) In order to strengthen the Union\u2019s capacity to immediately address exceptional migratory situations in one or more Member States characterised by a large or disproportionate influx of third-country nationals, which place significant and urgent demands on Member States\u2019 reception and detention facilities and on their systems and procedures for asylum and migration management, or to immediately address exceptional migratory situations in third countries due to political developments or conflicts, it should be possible to provide emergency assistance in accordance with the framework set out in this Regulation. (50) This Regulation should ensure the continuation of the European Migration Network set up by Council Decision 2008/381/EC (17) and should provide financial assistance in accordance with its objectives and tasks. (51) The policy objective of the Fund will also be addressed through financial instruments and budgetary guarantees under the policy windows of the InvestEU Programme established by Regulation (EU) 2021/523 of the European Parliament and of the Council (18). Financial support should be used to address market failures or sub-optimal investment situations in a proportionate manner, and actions should not duplicate or crowd out private financing or distort competition in the internal market. Actions should have clear Union added value. (52) Blending operations have a voluntary nature and are operations supported by the Union budget that combine non-repayable forms of support, repayable forms of support, or both, from the Union budget with repayable forms of support from promotional, development or other public finance institutions, as well as support from commercial finance institutions and investors. (53) This Regulation lays down a financial envelope for the entire duration of the Fund which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (19) for the European Parliament and the Council during the annual budgetary procedure. (54) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (20) (the \u2018Financial Regulation\u2019) applies to the Fund. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (55) For the purpose of implementation of actions under shared management, the Fund should form part of a coherent framework that consists of this Regulation, the Financial Regulation and Regulation (EU) 2021/1060. (56) Regulation (EU) 2021/1060 establishes the framework for action by ERDF, ESF+, the Cohesion Fund, the European Maritime, Fisheries and Aquaculture Fund, the Just Transition Fund, the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy, as part of the Integrated Border Management Fund, and it lays down, in particular, the rules concerning programming, monitoring and evaluation, management and control for Union funds implemented under shared management. Additionally, it is necessary to specify the objectives of the Fund in this Regulation, and to lay down specific provisions concerning the actions that may be financed under the Fund. (57) A pre-financing scheme for the Fund is set out in Regulation (EU) 2021/1060, and a specific pre-financing rate is set in this Regulation. In addition, in order to ensure that it is possible to react promptly to emergency situations, it is appropriate to set a specific pre-financing rate for emergency assistance. The pre-financing scheme should ensure that Member States have the means to provide support to beneficiaries as of the start of the implementation of their programmes. (58) The types of financing and methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, administrative burdens and the risk of non-compliance. When making that choice, use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation, should be considered. (59) In order to make the most use of the single audit principle, it is appropriate to set specific rules on the control and audit of projects in which international organisations, the internal control systems of which have been positively assessed by the Commission, are the beneficiaries. For such projects, managing authorities should have the possibility of limiting their management verifications, provided that the beneficiary delivers all necessary data and information on the progress of the project and on the eligibility of underlying expenditure in a timely manner. In addition, where a project implemented by such an international organisation is part of an audit sample, it should be possible for the audit authority to carry out its work in line with the principles of the International Standard on Related Services (ISRS) 4400, \u2018Engagements to Perform Agreed-upon Procedures Regarding Financial Information\u2019. (60) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (21) and Council Regulations (EC, Euratom) No 2988/95 (22), (Euratom, EC) No 2185/96 (23) and (EU) 2017/1939 (24), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (25). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. Member States should cooperate fully and provide all necessary assistance to Union institutions, bodies, offices and agencies in relation to the protection of the financial interests of the Union. (61) A third country which has concluded an agreement with the Union on the criteria and mechanisms for establishing the State responsible for examining a request for asylum lodged in a Member State or lodged in that third country should be allowed to participate in the Fund provided certain conditions are fulfilled. (62) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (63) Pursuant to Council Decision 2013/755/EU (26), persons and entities established in overseas countries or territories are eligible for funding subject to the rules and objectives of the Fund and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (64) Pursuant to Article 349 TFEU and in line with the communication of the Commission of 24 October 2017 entitled \u2018A stronger and renewed strategic partnership with the EU\u2019s outermost regions\u2019, endorsed by the Council in its conclusions of 12 April 2018, the relevant Member States should ensure that their national strategies and programmes address the specific challenges the outermost regions face in managing migration. The Fund should support those Member States with adequate resources to help those regions manage migration sustainably and handle possible situations of pressure. (65) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (27), the Fund should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Fund on the ground. In order to measure the achievements of the Fund, indicators and related targets should be established in relation to each specific objective of the Fund. Those indicators should include qualitative and quantitative indicators. (66) Through indicators and financial reporting, the Commission and the Member States should monitor the implementation of the Fund in accordance with the relevant provisions of Regulation (EU) 2021/1060 and this Regulation. Starting from 2023, Member States should submit to the Commission annual performance reports covering the latest accounting year. Those reports should contain information on the progress made in the implementation of Member States\u2019 programmes. The Member States should also submit summaries of those reports to the Commission. The Commission should translate those summaries into all official languages of the Union and make them publicly available on its website, together with the links to the Member States\u2019 websites referred to in Regulation (EU) 2021/1060. (67) Reflecting the importance of tackling climate change in accordance with the Union\u2019s commitments to implement the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (28), and the commitment to the United Nations\u2019 Sustainable Development Goals, the actions under this Regulation should contribute to the achievement of a 30 % target of all multiannual financial framework expenditure being spent on mainstreaming climate objectives and to working towards the ambition of 7,5 % of the budget reflecting biodiversity expenditure in 2024 and 10 % in 2026 and 2027 while considering the existing overlaps between climate and biodiversity goals. The Fund should support activities that respect the climate and environmental standards and priorities of the Union and would do no significant harm to the environmental objectives within the meaning of Article 17 of Regulation (EU) 2020/852 of the European Parliament and of the Council (29). (68) Regulation (EU) No 514/2014 of the European Parliament and of the Council (30) and any act applicable to the 2014\u20132020 programming period should continue to apply to programmes and projects supported under the Fund during the 2014\u20132020 programming period. Since the implementation period of Regulation (EU) No 514/2014 overlaps with the programming period covered by this Regulation, and in order to ensure continuity in the implementation of certain projects approved by that Regulation, provisions on the phasing of projects should be laid down. Each individual phase of the project should be implemented in accordance with the rules of the programming period under which it receives funding. (69) In order to supplement and amend non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the list of actions eligible for support under Annex III; the list of actions eligible for higher co-financing rates under Annex IV; operating support under Annex VII and the further development of the monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (70) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (31). The examination procedure should be used for the adoption of implementing acts that lay down common obligations on Member States, in particular obligations concerning the provision of information to the Commission, and the advisory procedure should be used for the adoption of implementing acts relating to the detailed arrangements for the provision of information to the Commission in the framework of programming and reporting, given their purely technical nature. The Commission should adopt immediately applicable implementing acts relating to the adoption of decisions to award emergency assistance provided for by this Regulation where, in duly justified cases relating to the nature and purpose of such assistance, imperative grounds of urgency so require. (71) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (72) In accordance with Articles 1 and 2 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, Ireland is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (73) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (74) In accordance with Article 193(2) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible for Union financing except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to the Union\u2019s interests, it should be possible, for a limited period of time at the beginning of the 2021-2027 multiannual financial framework, that costs incurred in respect of actions supported under this Regulation under direct management and which have already begun, be considered eligible for Union financing as of 1 January 2021, even if those costs were incurred before the grant application or the request for assistance was submitted. (75) It is appropriate to align the period of application of this Regulation with that of Council Regulation (EU, Euratom) 2020/2093 (32). (76) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the 2021-2027 multiannual financial framework, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the Asylum, Migration and Integration Fund (the \u2018Fund\u2019) for the period from 1 January 2021 to 31 December 2027. This Regulation lays down the objectives of the Fund, the budget for the period from 1 January 2021 to 31 December 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018applicant for international protection\u2019 means an applicant as defined in point (c) of Article 2 of Directive 2013/32/EU of the European Parliament and of the Council (33); (2) \u2018beneficiary of international protection\u2019 means a beneficiary of international protection as defined in point (b) of Article 2 of Directive 2011/95/EU of the European Parliament and of the Council (34); (3) \u2018blending operation\u2019 means actions supported by the Union budget, including within blending facilities within the meaning of point (6) of Article 2 of the Financial Regulation; (4) \u2018family member\u2019 means any third-country national defined as a family member under the Union law relevant to the policy area of action supported under the Fund; (5) \u2018humanitarian admission\u2019 means the admission following, where requested by a Member State, a referral from the European Asylum Support Office (EASO), the United Nations High Commissioner for Refugees (\u2018UNHCR\u2019), or another relevant international body, of third-country nationals or stateless persons from a third country to which they have been forcibly displaced to the territory of the Member States, and who are granted international protection or a humanitarian status under national law that provides for rights and obligations equivalent to those of Articles 20 to 34 of Directive 2011/95/EU for beneficiaries of subsidiary protection; (6) \u2018operating support\u2019 means a part of a Member State\u2019s allocation which may be used as support to the public authorities responsible for carrying out the tasks and providing the services which constitute a public service for the Union; (7) \u2018removal\u2019 means removal as defined in point (5) of Article 3 of Directive 2008/115/EC; (8) \u2018resettlement\u2019 means the admission following a referral from the UNHCR of third-country nationals or stateless persons from a third country to which they have been displaced, to the territory of the Member States, and who are granted international protection and have access to a durable solution in accordance with Union and national law; (9) \u2018return\u2019 means return as defined in point (3) of Article 3 of Directive 2008/115/EC; (10) \u2018specific actions\u2019 means transnational or national projects that bring Union added value in line with the objectives of the Fund for which one, several or all Member States may receive an additional allocation to their programmes; (11) \u2018third-country national\u2019 means any person, including a stateless person or a person with undetermined nationality, who is not a citizen of the Union as defined in Article 20(1) TFEU; (12) \u2018unaccompanied minor\u2019 means an unaccompanied minor as defined in point (l) of Article 2 of Directive 2011/95/EU; (13) \u2018Union actions\u2019 means transnational projects or projects of particular interest to the Union implemented in accordance with the objectives of the Fund; (14) \u2018vulnerable person\u2019 means any person defined as a vulnerable person under the Union law relevant to the policy area of action supported under the Fund. Article 3 Objectives of the Fund 1. The policy objective of the Fund is to contribute to the efficient management of migration flows and to the implementation, strengthening and development of the common policy on asylum and the common immigration policy, in accordance with the relevant Union acquis and fully respecting the international obligations of the Union and the Member States arising from the international instruments to which they are party. 2. Within the policy objective set out in paragraph 1, the Fund shall contribute to the following specific objectives: (a) strengthening and developing all aspects of the Common European Asylum System, including its external dimension; (b) strengthening and developing legal migration to the Member States in accordance with their economic and social needs, and promoting and contributing to the effective integration and social inclusion of third-country nationals; (c) contributing to countering irregular migration, enhancing effective, safe and dignified return and readmission, and promoting and contributing to effective initial reintegration in third countries; (d) enhancing solidarity and fair sharing of responsibility between the Member States, in particular as regards those most affected by migration and asylum challenges, including through practical cooperation. 3. Within the specific objectives set out in paragraph 2, the Fund shall be implemented through the implementation measures listed in Annex II. Article 4 Partnership For the purposes of the Fund, partnerships shall, pursuant to Article 8(1) of Regulation (EU) 2021/1060, include regional, local, urban and other public authorities or associations representing such authorities, relevant international organisations, non-governmental organisations, such as refugee organisations and migrant-led organisations, as well as national human rights institutions and equality bodies, and economic and social partners. Article 5 Scope of support 1. Within its objectives and in accordance with the implementation measures listed in Annex II, the Fund shall, in particular, support the actions listed in Annex III. To address unforeseen or new circumstances, the Commission is empowered to adopt delegated acts in accordance with Article 37 to amend the list of actions in Annex III in order to add new actions. 2. To achieve its objectives, the Fund may support, in line with the Union priorities, actions as referred to in Annex III in and in relation to third countries, where appropriate, in accordance with Article 7 or 24, as applicable. 3. As regards actions in and in relation to third countries, the Commission and the Member States, together with the European External Action Service, shall, in accordance with their respective responsibilities, ensure coordination with relevant Union policies, strategies and instruments. They shall, in particular, ensure that actions in and in relation to third countries: (a) are carried out in synergy and in coherence with other actions outside the Union supported through other Union instruments; (b) are coherent with external Union policy, respect the principle of policy coherence for development and are consistent with the strategic programming documents for the region or country in question; (c) focus on measures that are not development-oriented; and (d) serve the interests of internal Union policies and are consistent with activities undertaken within the Union. 4. The objectives of the Fund shall support actions focusing on one or more target groups within the scope of Articles 78 and 79 TFEU. Article 6 Gender equality and non-discrimination 1. The Member States and the Commission shall ensure the integration of the gender perspective and that gender equality and gender mainstreaming are taken into account and promoted throughout the preparation, implementation, monitoring, reporting and evaluation of programmes and projects supported under the Fund. 2. The Member States and the Commission shall take appropriate steps to exclude any form of discrimination prohibited by Article 21 of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019) during the preparation, implementation, monitoring, reporting and evaluation of programmes and projects supported under the Fund. Article 7 Third countries associated to the Fund 1. The Fund shall be open to third countries that fulfil the criteria listed in paragraph 2, in accordance with the conditions laid down in a specific agreement covering the participation of the third country in the Fund. 2. In order for a third country to be eligible to be associated to the Fund as referred to in paragraph 1, it shall have concluded with the Union an agreement on the criteria and mechanisms for establishing the State responsible for examining a request for asylum lodged in a Member State or lodged in that third country. 3. The specific agreement covering the participation of the third country in the Fund, shall at a minimum: (a) enable cooperation with the Member States and the Union institutions, bodies, offices and agencies in the area of asylum, migration and return in the spirit of the principle of solidarity and fair sharing of responsibility; (b) be underpinned, throughout the duration of the Fund, by the principles of non-refoulement, democracy, the rule of law and respect for human rights; (c) ensure a fair balance as regards the contributions made by, and the benefits received by, the third country participating in the Fund; (d) lay down the conditions of participation in the Fund, including the calculation of financial contributions to the Fund, and its administrative costs; (e) not confer on the third country any decision-making power in respect of the Fund; (f) guarantee the rights of the Union to ensure sound financial management and to protect its financial interests; (g) provide that the third country grants the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors in accordance with Article 8. The contributions referred to in point (d) of the first subparagraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. Article 8 Protection of the financial interests of the Union Where a third country participates in the Fund by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. CHAPTER II FINANCIAL AND IMPLEMENTATION FRAMEWORK SECTION 1 Common provisions Article 9 General principles 1. Support provided under the Fund shall complement national, regional and local intervention, and shall focus on bringing Union added value to the achievement of the objectives of the Fund. 2. The Commission and the Member States shall ensure that the support provided under the Fund and by the Member States is consistent with the relevant actions, policies and priorities of the Union, and is complementary to support provided under other Union instruments, in particular the external instruments, the European Social Fund Plus (ESF+) and the European Regional Development Fund (ERDF). 3. The Fund shall be implemented under direct, shared or indirect management in accordance with points (a), (b) and (c) of the first subparagraph of Article 62(1) of the Financial Regulation. Article 10 Budget 1. The financial envelope for the implementation of the Fund for the period from 1 January 2021 to 31 December 2027 shall be EUR 9 882 000 000 in current prices. 2. The financial envelope shall be used as follows: (a) EUR 6 270 000 000 shall be allocated to the Member States\u2019 programmes; (b) EUR 3 612 000 000 shall be allocated to the thematic facility referred to in Article 11. 3. Up to 0,42 % of the financial envelope shall be allocated to technical assistance at the initiative of the Commission, as referred to in Article 35 of Regulation (EU) 2021/1060. 4. In accordance with Article 26 of Regulation (EU) 2021/1060, up to 5 % of the initial allocation to a Member State from any of the funds under that Regulation under shared management may be transferred to the Fund under direct or indirect management at the request of that Member State. The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. Article 11 General provisions on the implementation of the thematic facility 1. The amount referred to in point (b) of Article 10(2) shall be allocated flexibly through a thematic facility using shared, direct or indirect management as set out in work programmes. Given the internal nature of the Fund, the thematic facility shall primarily serve internal Union policy in line with the specific objectives set out in Article 3(2). Funding from the thematic facility shall be used for its components, which are as follows: (a) specific actions; (b) Union actions; (c) emergency assistance as referred to in Article 31; (d) resettlement and humanitarian admission; (e) support to Member States for the transfer of applicants for international protection or of beneficiaries of international protection as a part of solidarity efforts as referred to in Article 20; and (f) the European Migration Network as referred to in Article 26. Technical assistance at the initiative of the Commission, as referred to in Article 35 of Regulation (EU) 2021/1060, shall also receive support from the amount referred to in point (b) of Article 10(2) of this Regulation. 2. Funding from the thematic facility shall address priorities with a high Union added value or be used to respond to urgent needs in line with agreed Union priorities as reflected in Annex II. The funding referred to in the first subparagraph of this paragraph, with the exception of funding used for emergency assistance in accordance with points (a) and (b) of the first subparagraph of Article 31(1), shall only support the actions listed in Annex III, including resettlement and humanitarian admission in accordance with Article 19 as part of the external dimension of the Union\u2019s migration policy. 3. The Commission shall engage with civil society organisations and relevant networks, in particular with a view to preparing and evaluating the work programmes for Union actions financed under the Fund. 4. A minimum of 20 % of the resources from the initial allocation to the thematic facility shall be allocated to the specific objective set out in point (d) of Article 3(2). 5. When funding from the thematic facility is provided under direct or indirect management to Member States, the Commission shall ensure that projects affected by a reasoned opinion delivered by the Commission in respect of infringement proceedings under Article 258 TFEU that put in doubt the legality and regularity of expenditure or the performance of those projects are not selected. 6. For the purposes of Article 23 and Article 24(2) of Regulation (EU) 2021/1060, where funding from the thematic facility is implemented under shared management, the Member State concerned shall ensure that, and the Commission shall assess whether, the envisaged actions are not affected by a reasoned opinion delivered by the Commission in respect of infringement proceedings under Article 258 TFEU that put in doubt the legality and regularity of expenditure or the performance of the actions. 7. The Commission shall establish the overall amount to be made available for the thematic facility under the annual appropriations of the Union budget. 8. The Commission shall, by means of implementing acts, adopt financing decisions as referred to in Article 110 of the Financial Regulation for the thematic facility identifying objectives and actions to be supported and specifying the amounts for each of the components referred to in the second subparagraph of paragraph 1 of this Article. Financing decisions shall set out, where applicable, the overall amount reserved for blending operations. Financing decisions may be annual or multiannual and may cover one or more components of the thematic facility referred to in the second subparagraph of paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 38(3) of this Regulation. 9. The thematic facility shall, in particular, support actions falling under implementation measure 2(d) of Annex II that are implemented by national, regional and local authorities or civil society organisations. In that regard, a minimum of 5 % of the initial allocation to the thematic facility shall target the implementation of integration measures by local and regional authorities. 10. The Commission shall ensure that the distribution of resources among the specific objectives set out in Article 3(2) is fair and transparent. The Commission shall report on the use and the distribution of the thematic facility between the components referred to in the second subparagraph of paragraph 1 of this Article, including on the support provided to actions in or in relation to third countries under the Union actions. 11. Following the adoption of a financing decision as referred to in paragraph 8, the Commission may amend the Member States\u2019 programmes accordingly. SECTION 2 Support and implementation under shared management Article 12 Scope 1. This section applies to the amount referred to in point (a) of Article 10(2) and additional resources to be implemented under shared management in accordance with the financing decision for the thematic facility referred to in Article 11. 2. Support under this section shall be implemented under shared management in accordance with Article 63 of the Financial Regulation and Regulation (EU) 2021/1060. Article 13 Budgetary resources 1. The amount referred to in point (a) of Article 10(2) shall be allocated to Member States\u2019 programmes indicatively as follows: (a) EUR 5 225 000 000 in accordance with Annex I; (b) EUR 1 045 000 000 for the adjustment of the allocations to the Member States\u2019 programmes referred to in Article 17(1). 2. Where the amount referred to in point (b) of paragraph 1 of this Article is not fully allocated, the remaining amount may be added to the amount referred to in point (b) of Article 10(2). Article 14 Pre-financing 1. In accordance with Article 90(4) of Regulation (EU) 2021/1060, the pre-financing for the Fund shall be paid in yearly instalments before 1 July of each year, subject to the availability of funds, as follows: (a) 2021: 4 %; (b) 2022: 3 %; (c) 2023: 5 %; (d) 2024: 5 %; (e) 2025: 5 %; (f) 2026: 5 %. 2. Where a Member State\u2019s programme is adopted after 1 July 2021, the earlier instalments shall be paid in the year of its adoption. Article 15 Co-financing rates 1. The contribution from the Union budget shall not exceed 75 % of the total eligible expenditure for a project. 2. The contribution from the Union budget may be increased to 90 % of the total eligible expenditure for projects implemented under specific actions. 3. The contribution from the Union budget may be increased to 90 % of the total eligible expenditure for actions listed in Annex IV. 4. The contribution from the Union budget may be increased to 100 % of the total eligible expenditure for operating support. 5. The contribution from the Union budget may be increased to 100 % of the total eligible expenditure for emergency assistance as referred to in Article 31. 6. The contribution from the Union budget may be increased to 100 % of the total eligible expenditure for technical assistance at the initiative of Member States within the limits set out in point (b)(vi) of Article 36(5) of the Regulation (EU) 2021/1060. 7. The Commission decision approving a Member State\u2019s programme shall set the co-financing rate and the maximum amount of support from the Fund for the types of action covered by the contribution referred to in paragraphs 1 to 6. 8. The Commission decision approving a Member State\u2019s programme shall set out for each type of action whether the co-financing rate is applied in respect of: (a) the total contribution, including the public and private contributions; or (b) the public contribution only. Article 16 Member States\u2019 programmes 1. Each Member State shall ensure that the priorities addressed in its programme are consistent with and respond to Union priorities and challenges in the area of asylum and migration management and are fully in accordance with the relevant Union acquis and agreed Union priorities, while fully respecting the international obligations of the Union and the Member States arising from the international instruments to which they are party. In defining the priorities of their programmes Member States shall ensure that the implementation measures listed in Annex II are adequately addressed in their programmes. Given the internal nature of the Fund, Member States\u2019 programmes shall primarily serve internal Union policy in line with the specific objectives set out in Article 3(2) of this Regulation. The Commission shall assess the Member States\u2019 programmes in accordance with Article 23 of Regulation (EU) 2021/1060. 2. Within the resources allocated in Article 13(1), and without prejudice to paragraph 3 of this Article, each Member State shall allocate within its programme: (a) a minimum of 15 % of its allocated resources to the specific objective set out in point (a) of Article 3(2); and (b) a minimum of 15 % of its allocated resources to the specific objective set out in point (b) of Article 3(2). 3. A Member State may allocate less than the minimum percentages referred to in paragraph 2 only if it provides a detailed explanation in its programme as to why allocating resources below that level would not jeopardise the achievement of the relevant objective. 4. The Commission shall ensure that the knowledge and expertise of the relevant decentralised agencies, in particular EASO, the European Border and Coast Guard Agency and the European Union Agency for Fundamental Rights, established by Council Regulation (EC) No 168/2007 (35), are taken into account as regards the areas of their competence, at an early stage and in a timely manner, in the development of the Member States\u2019 programmes. 5. The Commission may involve, where appropriate, relevant decentralised agencies, including those referred to in paragraph 4, in the monitoring and evaluation tasks as specified in Section 5, in particular with a view to ensuring that the actions implemented with the support of the Fund are compliant with the relevant Union acquis and agreed Union priorities. 6. Following the adoption of recommendations in accordance with Regulation (EU) No 1053/2013 which are within the scope of this Regulation, the Member State concerned shall examine, together with the Commission, how to address the findings and recommendations through its programme with the support of the Fund, where appropriate. The Commission may, where relevant, also draw on the expertise of decentralised agencies on specific issues falling within those agencies\u2019 competencies. 7. Where necessary, the programme of the Member State in question shall be amended in accordance with Article 24 of Regulation (EU) 2021/1060 to take into account the recommendations referred to in paragraph 6 of this Article. 8. In cooperation and consultation with the Commission and the relevant decentralised agencies as regards the areas of their competence, as applicable, the Member State concerned may reallocate resources under its programme with the aim of addressing the recommendations referred to in paragraph 6 where those recommendations have financial implications. 9. Member States shall in particular pursue the actions eligible for higher co-financing rates that are listed in Annex IV in their programmes. In the event of unforeseen or new circumstances or in order to ensure the effective implementation of funding, the Commission is empowered to adopt delegated acts in accordance with Article 37 to amend the list of actions eligible for higher co-financing rates in Annex IV. 10. Member States\u2019 programmes may allow for the inclusion of immediate relatives of persons covered by the integration measures referred to in Annex III to the extent necessary for the effective implementation of those measures. 11. Whenever a Member State decides to implement a project with or in a third country with the support of the Fund, the Member State concerned shall consult the Commission prior to the approval of the project. 12. Programming as referred to in Article 22(5) of Regulation (EU) 2021/1060 shall be based on the types of intervention set out in Table 1 of Annex VI to this Regulation and shall include an indicative breakdown of the programmed resources by type of intervention within each specific objective set out in Article 3(2) of this Regulation. Article 17 Mid-term review 1. In 2024, the Commission shall allocate to the programmes of the Member States concerned the additional amount referred to in point (b) of Article 13(1) in accordance with the criteria referred to in point (b) of paragraph 1 and paragraphs 2 to 5 of Annex I. Funding shall be effective as of 1 January 2025. 2. Where at least 10 % of the initial allocation to a programme referred to in point (a) of Article 13(1) of this Regulation has not been covered by payment applications submitted in accordance with Article 91 of Regulation (EU) 2021/1060, the Member State concerned shall not be eligible to receive the additional allocation for its programme referred to in point (b) of Article 13(1) of this Regulation. 3. When allocating the funds from the thematic facility referred to in Article 11 of this Regulation as of 1 January 2025, the Commission shall take into account the progress made by the Member States in achieving the milestones of the performance framework referred to in Article 16 of Regulation (EU) 2021/1060 and identified shortcomings in implementation. Article 18 Specific actions 1. A Member State may receive funding for specific actions in addition to its allocation under Article 13(1), provided that that funding is subsequently earmarked as such in its programme and is used to contribute to the implementation of the objectives of the Fund. 2. Funding for specific actions shall not be used for other actions in the Member State\u2019s programme, except in duly justified circumstances and as approved by the Commission through the amendment of the Member State\u2019s programme. Article 19 Resources for resettlement and humanitarian admission 1. Member States shall receive, in addition to their allocation under point (a) of Article 13(1), an amount of EUR 10 000 for each person admitted through resettlement. 2. Member States shall receive, in addition to their allocation under point (a) of Article 13(1), an amount of EUR 6 000 for each person admitted through humanitarian admission. 3. The amount referred to in paragraph 2 shall be increased to EUR 8 000 for each person admitted through humanitarian admission who belongs to one or more of the following vulnerable groups: (a) women and children at risk; (b) unaccompanied minors; (c) persons having medical needs that can be addressed only through humanitarian admission; (d) persons in need of humanitarian admission for legal or physical protection needs, including victims of violence or torture. 4. Where a Member State admits a person belonging to more than one of the categories referred to in paragraphs 2 and 3, it shall receive the amount only once in respect of that person. 5. Where appropriate, Member States may also be eligible to receive the respective amounts for family members of persons referred to in paragraphs 1, 2 and 3 if those family members are admitted to ensure family unity. 6. The amounts referred to in this Article shall take the form of financing not linked to costs in accordance with Article 125 of the Financial Regulation. 7. The amounts referred to in paragraphs 1, 2, 3 and 5 shall be allocated to the Member State\u2019s programme for the first time in the financing decision approving that programme. Those amounts shall not be used for other actions in the Member State\u2019s programme except in duly justified circumstances, as approved by the Commission through the amendment of that programme. Those amounts may be included in the payment applications to the Commission, provided that the person in respect of whom the amount is allocated was effectively resettled or admitted. 8. For the purposes of control and audit, Member States shall retain the information necessary to allow the proper identification of the persons resettled or admitted and of the date of their resettlement or admission. 9. To take account of current inflation rates, relevant developments in the field of resettlement, and other factors which might optimise the use of the financial incentive brought by the amounts referred to in paragraphs 1, 2 and 3 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 37 to adjust, if deemed appropriate, and within the limits of available resources, those amounts. Article 20 Resources for the transfer of applicants for international protection or of beneficiaries of international protection 1. A Member State shall receive, in addition to its allocation under Article 13(1) of this Regulation, an additional amount of EUR 10 000 for each applicant for international protection transferred from another Member State in accordance with Article 17 of Regulation (EU) No 604/2013 of the European Parliament and of the Council (36) or as a result of similar forms of relocation. 2. Where appropriate, Member States may also be eligible to receive the amount referred to in paragraph 1 of this Article for each family member of persons referred to in that paragraph, provided that those family members have been transferred to ensure family unity in accordance with Article 17 of Regulation (EU) No 604/2013 or have been transferred as a result of similar forms of relocation. 3. Member States shall receive, in addition to their allocation under Article 13(1), an additional amount of EUR 10 000 for each beneficiary of international protection transferred from another Member State. 4. Where appropriate, Member States may also be eligible to receive the respective amounts for family members of persons referred to in paragraph 3 if those family members have been transferred to ensure family unity. 5. The Member State covering the cost of transfers referred to in paragraphs 1 to 4 shall receive a contribution of EUR 500 for each applicant for international protection or beneficiary of international protection transferred to another Member State. 6. The amounts referred to in this Article shall take the form of financing not linked to costs in accordance with Article 125 of the Financial Regulation. 7. The amounts referred to in paragraphs 1 to 5 of this Article shall be allocated to the Member State\u2019s programme, provided that the person in respect of whom the amount is allocated was effectively transferred to a Member State or was registered as an applicant in the Member State responsible in accordance with Regulation (EU) No 604/2013, as applicable. Those amounts shall not be used for other actions in the Member State\u2019s programme except in duly justified circumstances, as approved by the Commission through the amendment of that programme. 8. For the purposes of control and audit, Member States shall retain the information necessary to allow the proper identification of the persons transferred and of the date of their transfer. 9. To take account of current inflation rates, relevant developments in the field of relocation and other factors which might optimise the use of the financial incentive brought by the amounts referred to in paragraphs 1, 3 and 5 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 37 to adjust, if deemed appropriate, and within the limits of available resources, those amounts. Article 21 Operating support 1. A Member State may use up to 15 % of the amount allocated to its programme under the Fund to finance operating support under the specific objectives of the Fund. 2. When using operating support, a Member State shall comply with the relevant Union acquis and the Charter. 3. A Member State shall explain, in its programme and in the annual performance report referred to in Article 35 of this Regulation, how the use of operating support contributes to the achievement of the objectives of the Fund. Before the approval of the Member State\u2019s programme, the Commission shall assess the baseline situation in the Member States which have indicated their intention to use operating support. The Commission shall take into account the information provided by those Member States and, where relevant, the information available as a result of the monitoring exercises which are carried out in accordance with Regulation (EU) No 1053/2013 and which are within the scope of this Regulation. 4. Operating support shall be concentrated on actions covered by expenditure as laid down in Annex VII. 5. To address unforeseen or new circumstances or to ensure the effective implementation of funding, the Commission is empowered to adopt delegated acts in accordance with Article 37 to amend the eligible actions listed in Annex VII. Article 22 Management verifications and audits of projects carried out by international organisations 1. This Article applies to international organisations or their agencies as referred to in point (c)(ii) of the first subparagraph of Article 62(1) of the Financial Regulation whose systems, rules and procedures have been positively assessed by the Commission pursuant to Article 154(4) and (7) of that Regulation for the purpose of indirectly implementing grants financed from the Union budget (\u2018international organisations\u2019). 2. Without prejudice to point (a) of the first paragraph of Article 83 of Regulation (EU) 2021/1060 and to Article 129 of the Financial Regulation, where the international organisation is a beneficiary as defined in point (9) of Article 2 of Regulation (EU) 2021/1060, the managing authority shall not be required to carry out the management verifications referred to in point (a) of the first subparagraph of Article 74(1) of Regulation (EU) 2021/1060, provided that the international organisation submits to the managing authority the documents referred to in points (a), (b) and (c) of the first subparagraph of Article 155(1) of the Financial Regulation. 3. Without prejudice to point (c) of the first subparagraph of Article 155(1) of the Financial Regulation, the management declaration to be submitted by the international organisation shall confirm that the project complies with applicable law and the conditions for support of the project. 4. In addition, where costs are to be reimbursed pursuant to point (a) of Article 53(1) of Regulation (EU) 2021/1060, the management declaration to be submitted by the international organisation shall confirm that: (a) invoices and proof of their payment by the beneficiary have been verified; (b) the accounting records or accounting codes maintained by the beneficiary for transactions linked to the expenditure declared to the managing authority have been verified. 5. Where costs are to be reimbursed pursuant to point (b), (c) or (d) of Article 53(1) of Regulation (EU) 2021/1060, the management declaration to be submitted by the international organisation shall confirm that the conditions for reimbursement of expenditure have been met. 6. The documents referred to in points (a) and (c) of the first subparagraph of Article 155(1) of the Financial Regulation shall be provided to the managing authority together with each payment claim submitted by the beneficiary. 7. The beneficiary shall submit the accounts to the managing authority each year by 15 October. The accounts shall be accompanied by an opinion of an independent audit body that has been drawn up in accordance with internationally accepted audit standards. That opinion shall establish whether the control systems in place function properly and are cost-effective and whether the underlying transactions are legal and regular. That opinion shall also state whether the audit work puts in doubt the assertions made in the management declarations submitted by the international organisation, including information on suspicions of fraud. That opinion shall provide assurance that the expenditure included in the payment claims submitted by the international organisation to the managing authority is legal and regular. 8. Without prejudice to existing possibilities for carrying out further audits as referred to in Article 127 of the Financial Regulation, the managing authority shall draw up the management declaration referred to in point (f) of the first subparagraph of Article 74(1) of Regulation (EU) 2021/1060. The managing authority shall do so by relying on the documents provided by the international organisation pursuant to paragraphs 2 to 5 and 7 of this Article, instead of by relying on the management verifications referred to in Article 74(1) of Regulation (EU) 2021/1060. 9. The document setting out the conditions for support referred to in Article 73(3) of Regulation (EU) 2021/1060 shall include the requirements set out in this Article. 10. Paragraph 2 shall not apply, and consequently a managing authority shall be required to carry out management verifications, where: (a) that managing authority identifies a specific risk of irregularity or an indication of fraud with respect to a project initiated or implemented by the international organisation; (b) the international organisation fails to submit to that managing authority the documents referred to in paragraphs 2 to 5 and 7; (c) the documents referred to in paragraphs 2 to 5 and 7 that have been submitted by the international organisation are incomplete. 11. Where a project, in which an international organisation is a beneficiary as defined in point (9) of Article 2 of Regulation (EU) 2021/1060, is part of a sample as referred to in Article 79 of that Regulation, the audit authority may perform its work on the basis of a sub-sample of transactions that relate to that project. Where errors are found in the sub-sample, the audit authority, if relevant, may request the auditor of the international organisation to assess the full scope and the total amount of errors in that project. SECTION 3 Support and implementation under direct or indirect management Article 23 Scope The Commission shall implement support under this Section either directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Article 24 Eligible entities 1. The following entities are eligible for Union financing: (a) legal entities established in: (i) a Member State or an overseas country or territory linked to it; (ii) a third country associated to the Fund pursuant to a specific agreement under Article 7, subject to it being covered by the work programme and conditions therein; (iii) a third country listed in the work programme, under the conditions specified in paragraph 3; (b) legal entities created under Union law or any international organisation relevant for the purposes of the Fund. 2. Natural persons are not eligible for Union financing. 3. Entities as referred to in point (a)(iii) of paragraph 1 shall participate as part of a consortium composed of at least two independent entities, at least one of which is established in a Member State. Entities participating as part of a consortium as referred to in the first subparagraph of this paragraph shall ensure that the actions in which they participate comply with the principles enshrined in the Charter and contribute to the achievement of the objectives of the Fund. Article 25 Union actions 1. At the Commission\u2019s initiative, the Fund may be used to finance Union actions related to the objectives of the Fund, in accordance with Annex III. 2. Union actions may provide funding in any of the forms laid down in the Financial Regulation, in particular grants, prizes and procurement. They may also provide funding in the form of financial instruments within blending operations. 3. Grants implemented under direct management shall be awarded and managed in accordance with Title VIII of the Financial Regulation. 4. Members of the evaluation committee assessing the proposals, referred to in Article 150 of the Financial Regulation, may be external experts. 5. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and shall be considered a sufficient guarantee under the Financial Regulation. Article 37(7) of Regulation (EU) 2021/695 of the European Parliament and of the Council (37) shall apply. Article 26 European Migration Network 1. The Fund shall support the European Migration Network and provide the financial assistance necessary for its activities and its future development. 2. The amount to be made available for the European Migration Network under the annual appropriations of the Fund and the work programme laying down the priorities for its activities shall be adopted by the Commission after approval by the Steering Board in accordance with point (a) of Article 4(5) of Decision 2008/381/EC. The decision of the Commission shall constitute a financing decision in accordance with Article 110 of the Financial Regulation. To ensure the timely availability of resources, the Commission may adopt the work programme for the European Migration Network in a separate financing decision. 3. Financial assistance provided for the activities of the European Migration Network shall take the form of grants to the National Contact Points referred to in Article 3 of Decision 2008/381/EC or procurements, as appropriate, in accordance with the Financial Regulation. Article 27 Blending operations Blending operations decided under the Fund shall be carried out in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. Article 28 Technical assistance at the initiative of the Commission In accordance with Article 35 of Regulation (EU) 2021/1060, the Fund may support technical assistance implemented at the initiative of, or on behalf of, the Commission, at a financing rate of 100 %. Article 29 Audits Audits of the use of the Union contribution carried out by persons or entities, including by persons or entities other than those mandated by the Union institutions, bodies, offices or agencies, shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. Article 30 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective, meaningful and proportionate targeted information to multiple audiences, including the media and the public. The visibility of Union funding shall be ensured and such information shall be provided, except in duly justified cases where it is not possible or appropriate to display such information publicly or where the release of such information is restricted by law, in particular for reasons of security, public order, criminal investigations or the protection of personal data. To ensure the visibility of Union funding, recipients of Union funding shall refer to the origin of that funding when publicly communicating on the action concerned, and shall display the Union emblem. 2. To reach the widest possible audience, the Commission shall implement information and communication actions relating to the Fund, to actions taken pursuant to the Fund and to the results obtained. Financial resources allocated to the Fund shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives of the Fund. 3. The Commission shall publish the work programmes of the thematic facility referred to in Article 11. For support provided under direct or indirect management, the Commission shall publish the information referred to in Article 38(2) of the Financial Regulation on a publicly available website and shall update that information regularly. That information shall be published in an open, machine-readable format which allows data to be sorted, searched, extracted and compared. SECTION 4 Support and implementation under shared, direct or indirect management Article 31 Emergency assistance 1. The Fund shall provide financial assistance to address urgent and specific needs in the event of duly justified emergency situations resulting from one or more of the following cases: (a) an exceptional migratory situation characterised by a large or disproportionate influx of third-country nationals into one or more Member States which places significant and urgent demands on those Member States\u2019 reception and detention facilities, and on their asylum and migration management systems and procedures; (b) an event of a mass influx of displaced persons within the meaning of Council Directive 2001/55/EC (38); (c) an exceptional migratory situation in a third country, including where persons in need of protection could be stranded due to political developments or conflicts, notably where it might have an impact on migration flows towards the Union. In response to such duly justified emergency situations, the Commission may decide to provide emergency assistance, including for voluntary relocation, within the limits of available resources. In such cases, the Commission shall inform the European Parliament and the Council in a timely manner. 2. Measures in third countries shall be implemented in accordance with Article 5(2) and (3). 3. Emergency assistance may be allocated to Member States\u2019 programmes in addition to the allocation under Article 13(1) and Annex I, provided that it is subsequently earmarked as such in the Member State\u2019s programme. That funding shall not be used for other actions in the Member State\u2019s programme except in duly justified circumstances and as approved by the Commission through the amendment of the Member State\u2019s programme. Pre-financing for emergency assistance may amount to 95 % of the Union contribution, subject to the availability of funds. 4. Grants implemented under direct management shall be awarded and managed in accordance with Title VIII of the Financial Regulation. 5. Where necessary for the implementation of an action, emergency assistance may cover expenditure which was incurred prior to the date of submission of the grant application or the request for assistance for that action, provided that that expenditure was not incurred prior to 1 January 2021. 6. On duly justified imperative grounds of urgency and to ensure that there is a timely availability of resources for emergency assistance, the Commission may separately adopt a financing decision, as referred to in Article 110 of the Financial Regulation, for emergency assistance by way of an immediately applicable implementing act in accordance with the procedure referred to in Article 38(4). Such an act shall remain in force for a period not exceeding 18 months. Article 32 Cumulative and alternative financing 1. An action that has received a contribution under the Fund may also receive a contribution from any other Union programme, including funds under shared management, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 2. In accordance with Article 73(4) of Regulation (EU) 2021/1060, the ERDF or the ESF+ may support actions attributed a Seal of Excellence label as defined in point (45) of Article 2 of that Regulation. In order to be attributed a Seal of Excellence label, the actions shall comply with the following cumulative conditions: (a) they have been assessed in a call for proposals under the Fund; (b) they comply with the minimum quality requirements of that call for proposals; (c) they cannot be financed under that call for proposals due to budgetary constraints. SECTION 5 Monitoring, reporting and evaluation Subsection 1 Common provisions Article 33 Monitoring and reporting 1. In compliance with its reporting requirements pursuant to point (h)(iii) of the first subparagraph of Article 41(3) of the Financial Regulation, the Commission shall present to the European Parliament and to the Council information on the core performance indicators listed in Annex V to this Regulation. 2. The Commission is empowered to adopt delegated acts in accordance with Article 37 to amend Annex V in order to make the necessary adjustments to core performance indicators listed in that Annex. 3. Indicators to report on the progress of the Fund towards the achievement of the specific objectives set out in Article 3(2) are set out in Annex VIII. For output indicators, the baselines shall be set at zero. The milestones set for 2024 and the targets set for 2029 shall be cumulative. 4. The performance reporting system shall ensure that data for monitoring the implementation and the results of the programme are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where appropriate, on Member States. 5. To ensure the effective assessment of the Fund\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts in accordance with Article 37 to amend Annex VIII to review or complement the indicators where considered necessary and to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework, including on project information to be provided by the Member States. Any amendment to Annex VIII shall apply only to projects selected after the entry into force of that amendment. Article 34 Evaluation 1. By 31 December 2024, the Commission shall carry out a mid-term evaluation of this Regulation. In addition to what is provided for in Article 45(1) of the Regulation (EU) 2021/1060, the mid-term evaluation shall assess the following: (a) the effectiveness of the Fund, including the progress made towards the achievement of its objectives, taking into account all relevant information already available, in particular the annual performance reports referred to in Article 35 and the output and result indicators set out in Annex VIII; (b) the efficiency of the use of resources allocated to the Fund and the efficiency of the management and control measures put in place to implement it; (c) the continued relevance and appropriateness of the implementation measures listed in Annex II; (d) the coordination, coherence and complementarity between the actions supported under the Fund and support provided by other Union funds; (e) the Union added value of actions implemented under the Fund. That mid-term evaluation shall take into account the results of the retrospective evaluation of the effects of the Asylum, Migration and Integration Fund for the 2014-2020 period. 2. In addition to what is provided for in Article 45(2) of Regulation (EU) 2021/1060, the retrospective evaluation shall include the elements listed in paragraph 1 of this Article. Moreover, the impact of the Fund shall also be evaluated. 3. The mid-term evaluation and the retrospective evaluation shall be carried out in a timely manner in order to contribute to the decision-making process, including, where appropriate, to the revision of this Regulation. 4. In the mid-term evaluation and retrospective evaluation, the Commission shall pay particular attention to the evaluation of actions implemented with, in or in relation to third countries in accordance with Article 7, Article 16(11) and Article 24. Subsection 2 Rules for shared management Article 35 Annual performance reports 1. By 15 February 2023 and by 15 February of each subsequent year up to and including 2031, Member States shall submit to the Commission an annual performance report as referred to in Article 41(7) of Regulation (EU) 2021/1060. The reporting period shall cover the last accounting year as defined in point (29) of Article 2 of Regulation (EU) 2021/1060 preceding the year of submission of the report. The report submitted by 15 February 2023 shall cover the period from 1 January 2021. 2. The annual performance reports shall, in particular, set out information on: (a) the progress in the implementation of the Member State\u2019s programme and in achieving the milestones and targets set out therein, taking into account the most recent data as required under Article 42 of Regulation (EU) 2021/1060; (b) any issues affecting the performance of the Member State\u2019s programme and the action taken to address them, including information on any reasoned opinions delivered by the Commission in respect of infringement proceedings under Article 258 TFEU linked to the implementation of the Fund; (c) the complementarity between the actions supported under the Fund and the support provided by other Union funds, in particular those actions taken in or in relation to third countries; (d) contribution of the Member State\u2019s programme to the implementation of the relevant Union acquis and action plans and to cooperation and solidarity between Member States; (e) the implementation of communication and visibility actions; (f) the fulfilment of the applicable enabling conditions and their application throughout the programming period, in particular compliance with fundamental rights; (g) the number of persons admitted through resettlement and humanitarian admission, by reference to the amounts set out in Article 19; (h) the number of applicants for international protection and of beneficiaries of international protection transferred from one Member State to another as referred to in Article 20; (i) the implementation of projects in or in relation to a third country. The annual performance reports shall include a summary covering all the points set out in the first subparagraph of this paragraph. The Commission shall ensure that the summaries provided by Member States are translated into all official languages of the Union and made publicly available. 3. The Commission may provide observations on annual performance reports within two months of the date of their receipt. Where the Commission does not provide observations by that deadline, the report shall be deemed to have been accepted. 4. On its website, the Commission shall provide the links to the websites referred to in Article 49(1) of Regulation (EU) 2021/1060. 5. In order to ensure uniform conditions for the implementation of this Article, the Commission shall adopt an implementing act establishing the template for the annual performance report. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 38(2). Article 36 Monitoring and reporting under shared management 1. Monitoring and reporting in accordance with Title IV of Regulation (EU) 2021/1060 shall use, as appropriate, the codes for the types of intervention set out in Annex VI to this Regulation. To address unforeseen or new circumstances and to ensure the effective implementation of the funding, the Commission is empowered to adopt delegated acts in accordance with Article 37 of this Regulation to amend Annex VI. 2. The indicators set out in Annex VIII to this Regulation shall be used in accordance with Article 16(1) and Articles 22 and 42 of Regulation (EU) 2021/1060. CHAPTER III TRANSITIONAL AND FINAL PROVISIONS Article 37 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in the second subparagraph of Article 5(1), Article 16(9), Article 19(9), Article 20(9), Article 21(5), Article 33(2) and (5) and Article 36(1) shall be conferred on the Commission until 31 December 2027. 3. The delegation of power referred to in the second subparagraph of Article 5(1), Article 16(9), Article 19(9), Article 20(9), Article 21(5), Article 33(2) and (5) and Article 36(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to the second subparagraph of Article 5(1), Article 16(9), Article 19(9), Article 20(9), Article 21(5), Article 33(2) or (5) or Article 36(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 38 Committee procedure 1. The Commission shall be assisted by the Committee for the Home Affairs Funds established by Article 32 of Regulation (EU) 2021/1148 of the European Parliament and of the Council (39). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. Article 39 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of the actions initiated pursuant to Regulation (EU) No 516/2014, which shall continue to apply to those actions until their closure. 2. The financial envelope for the Fund may also cover technical and administrative assistance expenses necessary to ensure the transition between the Fund and the measures adopted pursuant to Regulation (EU) No 516/2014. 3. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, taking into account the delayed entry into force of this Regulation, and in order to ensure continuity, for a limited period, costs incurred in respect of actions supported under this Regulation under direct management and which have already begun may be considered eligible for financing as of 1 January 2021, even if those costs were incurred before the grant application or the request for assistance was submitted. 4. Member States may continue after 1 January 2021 to support a project selected and started under Regulation (EU) No 516/2014, in accordance with Regulation (EU) No 514/2014, provided that all of the following conditions are met: (a) the project has two phases identifiable from a financial point of view with separate audit trails; (b) the total cost of the project exceeds EUR 500 000; (c) payments made by the responsible authority to beneficiaries for the first phase of the project shall be included in payment requests to the Commission under Regulation (EU) No 514/2014 and expenditure for the second phase of the project shall be included in payment applications under Regulation (EU) 2021/1060; (d) the second phase of the project complies with the applicable law and is eligible for support from the Fund under this Regulation and Regulation (EU) 2021/1060; (e) the Member State commits to complete the project, render it operational and report on it in the annual performance report submitted by 15 February 2024. The provisions of this Regulation and of Regulation (EU) 2021/1060 shall apply to the second phase of a project as referred to in the first subparagraph of this paragraph. This paragraph shall apply only to projects which have been selected under shared management pursuant to Regulation (EU) No 514/2014. Article 40 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 7 July 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. LOGAR (1) OJ C 62, 15.2.2019, p. 184. (2) OJ C 461, 21.12.2018, p. 147. (3) Position of the European Parliament of 13 March 2019 (OJ C 23, 21.1.2021, p. 356) and position of the Council at first reading of 14 June 2021 (OJ C 259, 2.7.2021, p. 1). Position of the European Parliament of 6 July 2021 (not yet published in the Official Journal). (4) Decision No 573/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the European Refugee Fund for the period 2008 to 2013 as part of the General programme \u2018Solidarity and Management of Migration Flows\u2019 and repealing Council Decision 2004/904/EC (OJ L 144, 6.6.2007, p. 1). (5) Council Decision 2007/435/EC of 25 June 2007 establishing the European Fund for the Integration of third-country nationals for the period 2007 to 2013 as part of the General programme \u2018Solidarity and Management of Migration Flows\u2019 (OJ L 168, 28.6.2007, p. 18). (6) Decision No 575/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the European Return Fund for the period 2008 to 2013 as part of the General Programme \u2018Solidarity and Management of Migration Flows\u2019 (OJ L 144, 6.6.2007, p. 45). (7) Regulation (EU) No 516/2014 of the European Parliament and of the Council of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC (OJ L 150, 20.5.2014, p. 168). (8) Regulation (EU) No 439/2010 of the European Parliament and of the Council of 19 May 2010 establishing a European Asylum Support Office (OJ L 132, 29.5.2010, p. 11). (9) Regulation (EU) 2021/1057 of the European Parliament and of the Council of 24 June 2021 establishing the European Social Fund Plus (ESF+) and repealing Regulation (EU) No 1296/2013 (OJ L 231, 30.6.2021, p. 21). (10) Regulation (EU) 2021/1058 of the European Parliament and of the Council of 24 June 2021 on the European Regional Development Fund and on the Cohesion Fund (OJ L 231, 30.6.2021, p. 60). (11) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (12) Directive 2009/52/EC of the European Parliament and of the Council of 18 June 2009 providing for minimum standards on sanctions and measures against employers of illegally staying third-country nationals (OJ L 168, 30.6.2009, p. 24). (13) Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, and replacing Council Framework Decision 2002/629/JHA (OJ L 101, 15.4.2011, p. 1). (14) Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, p. 1). (15) Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, p. 27). (16) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). (17) Council Decision 2008/381/EC of 14 May 2008 establishing a European Migration Network (OJ L 131, 21.5.2008, p. 7). (18) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (19) OJ L 433 I, 22.12.2020, p. 28. (20) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (21) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (22) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (23) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (24) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (25) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (26) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (\u2018Overseas Association Decision\u2019) (OJ L 344, 19.12.2013, p. 1). (27) OJ L 123, 12.5.2016, p. 1. (28) OJ L 282, 19.10.2016, p. 4. (29) Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13). (30) Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 150, 20.5.2014, p. 112). (31) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (32) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (33) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60). (34) Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted (OJ L 337, 20.12.2011, p. 9). (35) Council Regulation (EC) No 168/2007 of 15 February 2007 establishing a European Union Agency for Fundamental Rights (OJ L 53, 22.2.2007, p. 1). (36) Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person (OJ L 180, 29.6.2013, p. 31). (37) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (38) Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof (OJ L 212, 7.8.2001, p. 12). (39) Regulation (EU) 2021/1148 of the European Parliament and of the Council of 7 July 2021 establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy (see page 48 of this Official Journal). ANNEX I CRITERIA FOR THE ALLOCATION OF FUNDING TO THE MEMBER STATES\u2019 PROGRAMMES 1. The budgetary resources available under Article 13 shall be broken down between the Member States as follows: (a) at the start of the programming period, each Member State shall receive a fixed amount of EUR 8 000 000 from the Fund, with the exception of Cyprus, Malta and Greece, which shall each receive a fixed amount of EUR 28 000 000; (b) the remaining budgetary resources referred to in Article 13 shall be distributed based on the following criteria: \u2014 35 % for asylum; \u2014 30 % for legal migration and integration; \u2014 35 % for countering irregular migration including returns. 2. The following criteria in the area of asylum shall be taken into account and shall be weighted as follows: (a) 30 % in proportion to the number of persons who fall into one of the following categories: \u2014 any third-country national or stateless person having been granted the status defined by the Geneva Convention relating to the Status of Refugees of 28 July 1951 as amended by the New York Protocol of 31 January 1967; \u2014 any third-country national or stateless person enjoying a form of subsidiary protection within the meaning of Directive 2011/95/EU; \u2014 any third-country national or stateless person enjoying temporary protection within the meaning of Directive 2001/55/EC (1); (b) 60 % in proportion to the number of third-country nationals or stateless persons who have applied for international protection; (c) 10 % in proportion to the number of third-country nationals or stateless persons who are being or have been resettled in a Member State. 3. The following criteria in the area of legal migration and integration shall be taken into account and shall be weighted as follows: (a) 50 % in proportion to the total number of legally residing third-country nationals in a Member State; (b) 50 % in proportion to the number of third-country nationals who have obtained a first residence permit; however, the following categories of persons shall not be included: \u2014 third-country nationals issued with a work-related first residence permit valid for less than 12 months; \u2014 third-country nationals admitted for the purposes of studies, pupil exchange, unremunerated training or voluntary service in accordance with Council Directive 2004/114/EC (2) or, where applicable, Directive (EU) 2016/801 of the European Parliament and of the Council (3); \u2014 third-country nationals admitted for purposes of scientific research in accordance with Council Directive 2005/71/EC (4) or, where applicable, Directive (EU) 2016/801. 4. The following criteria in the area of countering irregular migration including returns shall be taken into account and shall be weighted as follows: (a) 70 % in proportion to the number of third-country nationals who do not or no longer fulfil the conditions for entry and stay in the territory of the Member State and who are subject to a return decision under national law, i.e. an administrative or judicial decision or act, stating or declaring the illegality of stay and imposing an obligation to return; (b) 30 % in proportion to the number of third-country nationals who have actually left the territory of the Member State following an administrative or judicial order to leave, whether undertaken voluntarily or under coercion. 5. For initial allocation the reference figures shall be based upon the annual statistical data produced by the Commission (Eurostat) covering the years 2017, 2018 and 2019 on the basis of data provided by Member States prior to the date of application of this Regulation in accordance with Union law. For the mid-term review, the reference figures shall be based upon the annual statistical data produced by the Commission (Eurostat) covering the years 2021, 2022 and 2023 on the basis of data provided by Member States in accordance with Union law. Where Member States have not supplied the Commission (Eurostat) with the statistical data concerned, they shall provide provisional data as soon as possible. 6. Before accepting the data referred to in paragraph 5 as reference figures, the Commission (Eurostat) shall evaluate the quality, comparability and completeness of the statistical information in accordance with normal operational procedures. At the request of the Commission (Eurostat), Member States shall provide it with all the necessary information to do so. (1) Data to be taken into account only in case of the activation of Directive 2001/55/EC. (2) Council Directive 2004/114/EC of 13 December 2004 on the conditions of admission of third-country nationals for the purposes of studies, pupil exchange, unremunerated training or voluntary service (OJ L 375, 23.12.2004, p. 12). (3) Directive (EU) 2016/801 of the European Parliament and of the Council of 11 May 2016 on the conditions of entry and residence of third-country nationals for the purposes of research, studies, training, voluntary service, pupil exchange schemes or educational projects and au pairing (OJ L 132, 21.5.2016, p. 21). (4) Council Directive 2005/71/EC of 12 October 2005 on a specific procedure for admitting third-country nationals for the purposes of scientific research (OJ L 289, 3.11.2005, p. 15). ANNEX II IMPLEMENTATION MEASURES 1. The Fund shall contribute to the specific objective set out in point (a) of Article 3(2) by focusing on the following implementation measures: (a) ensuring the uniform application of the Union acquis and of the priorities related to the Common European Asylum System; (b) supporting the capacity of Member States\u2019 asylum systems as regards infrastructures and services where necessary, including at local and regional level; (c) enhancing cooperation and partnership with third countries for the purpose of managing migration, including by enhancing their capacities to improve the protection of persons in need of international protection in the context of global cooperation efforts; (d) providing technical and operational assistance to one or several Member States, including in cooperation with EASO. 2. The Fund shall contribute to the specific objective set out in point (b) of Article 3(2) by focusing on the following implementation measures: (a) supporting the development and implementation of policies promoting legal migration and the implementation of the Union legal migration acquis, including family reunification and the enforcement of labour standards; (b) supporting measures to facilitate regular entry into and residence in the Union; (c) enhancing cooperation and partnership with third countries for the purpose of managing migration, including through legal avenues of entry to the Union, in the context of global cooperation efforts in the area of migration; (d) promoting integration measures for the social and economic inclusion of third-country nationals and protection measures for vulnerable persons in the context of integration measures, facilitating family reunification and preparing for the active participation of third-country nationals in, and their acceptance by, the receiving society, with the involvement of national and, in particular, regional or local authorities and civil society organisations, including refugee organisations and migrant-led organisations, and social partners. 3. The Fund shall contribute to the specific objective set out in point (c) of Article 3(2) by focusing on the following implementation measures: (a) ensuring the uniform application of the Union acquis and policy priorities regarding infrastructure, procedures and services; (b) supporting an integrated and coordinated approach to return management at the Union and Member State level, to the development of capacities for effective, dignified and sustainable return, and to reducing incentives for irregular migration; (c) supporting assisted voluntary return, family tracing and reintegration, while respecting the best interests of the child; (d) strengthening cooperation with third countries and their capacity, with respect to readmission and sustainable return. 4. The Fund shall contribute to the specific objective set out in point (d) of Article 3(2) by focusing on the following implementation measures: (a) enhancing solidarity and cooperation with third countries affected by migratory flows, including through resettlement in the Union and through other legal avenues to protection in the Union; (b) supporting transfers from one Member State to another of applicants for international protection or beneficiaries of international protection. ANNEX III SCOPE OF SUPPORT 1. Within the policy objective set out in Article 3(1), the Fund shall in particular support: (a) the establishment and development of national, regional and local strategies in relation to asylum, legal migration, integration, return and irregular migration in accordance with the relevant Union acquis; (b) the setting up of administrative structures, tools and systems, including ICT systems, and the training of staff, including the staff of local authorities and of other relevant stakeholders, in cooperation with relevant decentralised agencies, where appropriate; (c) the establishment of contact points at the national, regional and local levels to provide impartial guidance, practical information and assistance regarding all aspects of the Fund to potential beneficiaries and eligible entities; (d) the development, monitoring and evaluation of policies and procedures, including the collection, exchange and analysis of information and data; the dissemination of qualitative and quantitative data and statistics on migration and international protection; and the development and application of common statistical tools, methods and indicators for measuring progress and assessing policy developments; (e) the exchange of information, best practices and strategies; mutual learning, studies and research; the development and implementation of joint actions and operations; and the setting-up of transnational cooperation networks; (f) assistance and support services provided in a gender-sensitive manner that are consistent with the status and the needs of the person concerned, in particular vulnerable persons; (g) actions aimed at the effective protection of children in migration, including the implementation of assessments of the best interests of the child, the strengthening of guardianship systems, as well as the development, monitoring and evaluation of child safeguarding policies and procedures; (h) actions aimed at enhancing awareness among stakeholders and the general public of policies relating to asylum, integration, legal migration and return, with specific attention to vulnerable persons, including minors. 2. Within the specific objective set out in point (a) of Article 3(2), the Fund shall in particular support: (a) the provision of material aid, including assistance at the border; (b) the conducting of asylum procedures in accordance with the asylum acquis, including the provision of support services such as translation and interpretation, legal assistance, family tracing and other services which are consistent with the status of the person concerned; (c) the identification of applicants with special procedural or reception needs, including the early identification of victims of trafficking, with a view to their referral to specialised services such as psycho-social and rehabilitation services; (d) the provision of specialised services such as qualified psycho-social and rehabilitation services to applicants with special procedural or reception needs; (e) the establishment or improvement of reception accommodation infrastructure, such as small scale infrastructure addressing the needs of families with minors, including those provided by local and regional authorities and including the possible joint use of such facilities by more than one Member State; (f) the enhancement of the capacity of Member States to collect, analyse and share among their competent authorities country of origin information; (g) actions related to Union resettlement programmes or national resettlement and humanitarian admission schemes, including the conducting of procedures for their implementation; (h) the enhancement of the capacities of third countries to improve the protection of persons in need of protection, including through supporting the development of protection systems for children in migration; (i) the establishment, development and improvement of effective alternatives to detention, in particular in relation to unaccompanied minors and families, and including, where appropriate, non-institutionalised care integrated into national child protection systems. 3. Within the specific objective set out in point (b) of Article 3(2), the Fund shall in particular support: (a) information packages and campaigns to raise awareness of legal migration channels to the Union, including on the Union legal migration acquis; (b) the development of mobility schemes to the Union, such as circular or temporary migration schemes, including training to enhance employability; (c) cooperation between third countries and the recruitment agencies, the employment services and the immigration services of Member States; (d) the assessment and recognition of skills and qualifications, including professional experience, acquired in a third country, as well as their transparency, and their equivalence with those of a Member State; (e) assistance in the context of applications for family reunification to ensure a harmonised implementation of Council Directive 2003/86/EC (1); (f) assistance, including legal assistance and representation, in relation to a change of status for third-country nationals already legally residing in a Member State, in particular in relation to the acquisition of a legal residence status as defined at Union level; (g) assistance to third-country nationals seeking to exercise their rights, in particular related to mobility, under Union legal migration instruments; (h) integration measures, such as tailored support in accordance with the needs of third-country nationals, and integration programmes focusing on counselling, education, language and other training, such as civic orientation courses and professional guidance; (i) actions promoting equality in access to public and private services by third-country nationals and the provision of such services to third-country nationals, including access to education, healthcare and psycho-social support and adapting such services to the needs of the target group; (j) cooperation between governmental and non-governmental bodies in an integrated manner, including through coordinated integration-support centres, such as one-stop shops; (k) actions enabling and supporting the introduction of third-country nationals to, and their active participation in, the receiving society and actions promoting acceptance by the receiving society; (l) promoting exchanges and dialogue between third-country nationals, the receiving society and public authorities, including through consultation with third-country nationals, and intercultural and inter-religious dialogue; (m) building the capacity of integration services provided by local authorities and other relevant stakeholders. 4. Within the specific objective set out in point (c) of Article 3(2), the Fund shall in particular support: (a) the establishment or improvement of open reception or detention infrastructure, including the possible joint use of such facilities by more than one Member State; (b) the introduction, development, implementation and improvement of effective alternative measures to detention, including community-based case management, in particular in relation to unaccompanied minors and families; (c) the introduction and reinforcement of independent and effective forced-return monitoring systems, as laid down in Article 8(6) of Directive 2008/115/EC; (d) the countering of incentives for irregular migration, including the employment of irregular migrants, through effective and adequate inspections based on risk assessment, the training of staff, the setting-up and implementation of mechanisms through which irregular migrants can claim back payments and lodge complaints against their employers, and information and awareness-raising campaigns to inform employers and irregular migrants about their rights and obligations pursuant to Directive 2009/52/EC; (e) the preparation of returns, including measures leading to the issuing of return decisions, the identification of third-country nationals, the issuing of travel documents and family tracing; (f) cooperation with the consular authorities and immigration services or other relevant authorities and services of third countries with a view to obtaining travel documents, facilitating returns and ensuring readmission, including through the deployment of third-country liaison officers; (g) return assistance, in particular assisted voluntary return and information about assisted voluntary return programmes, including by providing specific guidance for children in return procedures; (h) removal operations, including related measures, in accordance with the standards laid down in Union law, with the exception of support for coercive equipment; (i) measures to support the returnee\u2019s sustainable return and reintegration, including cash-incentives, training, placement and employment assistance and start-up support for economic activities; (j) facilities and support services in third countries to ensure appropriate temporary accommodation and reception upon arrival and, where appropriate, a fast transition to community-based accommodation; (k) cooperation with third countries regarding countering irregular migration and regarding effective return and readmission; (l) measures aimed at raising awareness of the appropriate legal channels for migration and the risks of irregular immigration; (m) assistance and actions in third countries which help to improve effective cooperation between third countries and the Union and its Member States regarding return and readmission and to support reintegration into the society of origin. 5. Within the specific objective set out in point (d) of Article 3(2), the Fund shall in particular support: (a) the implementation of voluntary transfers from one Member State to another of either applicants for international protection or beneficiaries of international protection; (b) operational support in terms of seconded staff or financial assistance provided by a Member State to another Member State affected by migration challenges, including support provided to EASO; (c) the voluntary implementation of national resettlement or humanitarian admission schemes; (d) support by a Member State to another Member State affected by migration challenges in terms of establishment or improvement of reception infrastructure. (1) Council Directive 2003/86/EC of 22 September 2003 on the right to family reunification (OJ L 251, 3.10.2003, p. 12). ANNEX IV ACTIONS ELIGIBLE FOR HIGHER CO-FINANCING RATES IN ACCORDANCE WITH ARTICLES 15(3) AND 16(9) \u2014 Integration measures implemented by local and regional authorities and civil society organisations, including refugee organisations and migrant-led organisations; \u2014 Actions to develop and implement effective alternatives to detention; \u2014 Assisted voluntary return and reintegration programmes and related activities; \u2014 Measures targeting vulnerable persons and applicants for international protection with special reception or procedural needs, including measures to ensure effective protection of minors, in particular unaccompanied minors, including through alternative, non-institutionalised care systems. ANNEX V CORE PERFORMANCE INDICATORS AS REFERRED TO IN ARTICLE 33(1) All indicators related to persons shall be reported by age brackets (< 18, 18-60, > 60) and by gender. Specific objective set out in point (a) of Article 3(2) 1. Number of participants who consider the training useful for their work. 2. Number of participants who report three months after the training activity that they are using the skills and competences acquired during the training. 3. Number of persons placed in alternatives to detention, separately specifying: 3.1. the number of unaccompanied minors placed in alternatives to detention; 3.2. the number of families placed in alternatives to detention. Specific objective set out in point (b) of article 3(2) 1. Number of participants in language courses who, upon leaving the language course, have improved their proficiency level in the host-country language by at least one level in the Common European Framework of Reference for Languages or national equivalent. 2. Number of participants who report that the activity was helpful for their integration. 3. Number of participants who applied for the recognition or assessment of qualifications or skills acquired in a third country. 4. Number of participants who applied for a long-term residence status. Specific objective set out in point (c) of Article 3(2) 1. Number of returnees voluntarily returned. 2. Number of returnees who were removed. 3. Number of returnees subject to alternatives to detention. Specific objective set out in point (d) of Article 3(2) 1. Number of applicants for and beneficiaries of international protection transferred from one Member State to another. 2. Number of persons resettled. 3. Number of persons admitted through humanitarian admission. ANNEX VI TYPES OF INTERVENTION TABLE 1: CODES FOR THE INTERVENTION FIELD DIMENSION I. Common European Asylum System 001 Reception conditions 002 Asylum procedures 003 Implementation of the Union acquis 004 Children in migration 005 Persons with special reception and procedural needs 006 Union resettlement programmes or national resettlement and humanitarian admission schemes (Annex III, point 2(g)) 007 Operating support II. Legal migration and integration 001 Development of integration strategies 002 Victims of trafficking in human beings 003 Integration measures \u2013 information and orientation, one-stop shops 004 Integration measures \u2013 language training 005 Integration measures \u2013 civics and other training 006 Integration measures \u2013 introduction, participation, exchanges host society 007 Integration measures \u2013 basic needs 008 Pre-departure measures 009 Mobility schemes 010 Acquisition of legal residence 011 Vulnerable persons, including unaccompanied minors 012 Operating support III. Return 001 Alternatives to detention 002 Reception/detention conditions 003 Return procedures 004 Assisted voluntary return 005 Reintegration assistance 006 Removal/Return operations 007 Forced-return monitoring system 008 Vulnerable persons, including unaccompanied minors 009 Measures addressing incentives for irregular migration 010 Operating support IV. Solidarity and fair sharing of responsibility 001 Transfers to another Member State (\u2018relocation\u2019) 002 Support by a Member State to another Member State, including support provided to EASO 003 Resettlement (Article 19) 004 Humanitarian admission (Article 19) 005 Support, in terms of reception infrastructure, to another Member State 006 Operating support V. Technical assistance 001 Information and communication 002 Preparation, implementation, monitoring and control 003 Evaluation and studies, data collection 004 Capacity building TABLE 2: CODES FOR THE TYPE OF ACTION DIMENSION 001 Development of national strategies 002 Capacity building 003 Education and training for third-country nationals 004 Development of statistical tools, methods and indicators 005 Exchange of information and best practices 006 Joint actions/operations between Member States 007 Campaigns and information 008 Exchange and secondment of experts 009 Studies, pilot projects, risk assessments 010 Preparatory, monitoring, administrative and technical activities 011 Provision of assistance and support services to third-country nationals 012 Infrastructure 013 Equipment TABLE 3: CODES FOR THE IMPLEMENTATION DIMENSION 001 Actions covered by Article 15(1) 002 Specific actions 003 Actions listed in Annex IV 004 Operating support 005 Emergency assistance TABLE 4: CODES FOR THE PARTICULAR THEMES DIMENSION 001 Cooperation with third countries 002 Actions in or in relation to third countries 003 None of the above ANNEX VII EXPENDITURE ELIGIBLE FOR OPERATING SUPPORT Within all specific objectives set out in Article 3(2), operating support shall cover: \u2014 staff costs; \u2014 service costs, such as maintenance or replacement of equipment, including ICT systems; \u2014 service costs, such as maintenance and repair of infrastructure. ANNEX VIII OUTPUT AND RESULT INDICATORS AS REFERRED TO IN ARTICLE 33(3) All indicators relating to persons shall be reported by age brackets (< 18, 18-60, > 60) and by gender. Specific objective set out in point (a) of Article 3(2) Output indicators 1. Number of participants supported, separately specifying: 1.1. the number of participants who received legal assistance; 1.2. the number of participants benefiting from types of support other than legal assistance, including information and assistance throughout the asylum procedure (1); 1.3. the number of vulnerable participants assisted. 2. Number of participants in training activities. 3. Number of newly created places in reception infrastructure in accordance with Union acquis, separately specifying: 3.1. the number of newly created places for unaccompanied minors. 4. Number of renovated or refurbished places in reception infrastructure in accordance with Union acquis, separately specifying: 4.1. the number of renovated or refurbished places for unaccompanied minors. Result indicators 5. Number of participants who consider the training useful for their work. 6. Number of participants who report three months after the training activity that they are using the skills and competences acquired during the training. 7. Number of persons placed in alternatives to detention, separately specifying: 7.1. the number of unaccompanied minors placed in alternatives to detention; 7.2. the number of families placed in alternatives to detention. Specific objective set out in point (b) of Article 3(2) Output indicators 1. Number of participants in pre-departure measures. 2. Number of local and regional authorities supported to implement integration measures. 3. Number of participants supported, separately specifying: 3.1. the number of participants in a language course; 3.2. the number of participants in a civic orientation course; 3.3. the number of participants who received personalised professional guidance. 4. Number of information packages and campaigns to raise awareness of legal migration channels to the Union. 5. Number of participants receiving information or assistance in applying for family reunification. 6. Number of participants benefitting from mobility schemes. 7. Number of integration projects where local and regional authorities are the beneficiary. Result indicators 8. Number of participants in language courses who, upon leaving the language course, have improved their proficiency level in the host-country language by at least one level in the Common European Framework of Reference for Languages or national equivalent. 9. Number of participants who report that the activity was helpful for their integration. 10. Number of participants who applied for their qualification or skills acquired in a third country to be recognised or assessed. 11. Number of participants who applied for a long-term residence status. Specific objective set out in point (c) of Article 3(2) Output indicators 1. Number of participants in training activities. 2. Number of items of equipment purchased, including number of ICT systems purchased or updated. 3. Number of returnees who received reintegration assistance. 4. Number of places in detention centres created. 5. Number of places in detention centres refurbished or renovated. Result indicators 6. Number of returnees voluntarily returned. 7. Number of returnees who were removed. 8. Number of returnees subject to alternatives to detention. Specific objective set out in point (d) of Article 3(2) Output indicators 1. Number of staff trained. 2. Number of participants who received pre-departure support. Result indicators 3. Number of applicants for and beneficiaries of international protection transferred from one Member State to another. 4. Number of persons resettled. 5. Number of persons admitted through humanitarian admission. (1) This indicator is generated automatically for reporting purposes by the system by subtracting the number of participants who received legal assistance from the number of participants supported. The data for this indicator is generated by SFC2021 for reporting purposes. Member States do not need to report data for this indicator, nor do they need to set milestones or targets.", "summary": "Asylum, Migration and Integration Fund (2021-2027) Asylum, Migration and Integration Fund (2021-2027) SUMMARY OF: Regulation (EU) 2021/1147 establishing the Asylum, Migration and Integration Fund WHAT IS THE AIM OF THE REGULATION? It establishes the Asylum, Migration and Integration Fund, which aims to contribute to the efficient management of migration flows and to help implement, strengthen and develop the common asylum and immigration policies of the European Union (EU). KEY POINTS The regulation setting up the Asylum, Migration and Integration Fund (AMIF) 2021-2027 is one of several regulations adopted by the EU in the area of freedom, justice and security. These include: Regulation (EU) 2021/1148 establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy (see summary); Regulation (EU) 2021/1149 establishing the Internal Security Fund (see summary). Objectives The fund has 4 specific objectives: strengthening and developing the Common European Asylum System, including its external dimension; strengthening and developing legal migration to EU Member States, which includes promoting integration and social inclusion; contributing to efforts countering illegal migration and enhancing safe and dignified return and readmission; enhancing solidarity and the sharing of responsibility between Member States. Budget and allocation of funds The fund has a budget of \u20ac9.882 billion for the period of 1 January 2021 to 31 December 2027, the duration of the multiannual financial framework. \u20ac6.270 billion is allocated to Member State programmes and \u20ac3.612 billion to the \u2018thematic facility\u2019, which has several components including specific actionsdirect management actions at EU levelemergency assistance, resettlement and relocationthe European Migration Network. Each Member State receives a fixed sum of \u20ac8 million at the beginning of the programming period, with the exception of Cyprus, Greece and Malta which receive \u20ac28 million each. The remaining allocation is divided as follows 35% for asylum30% for legal migration and integration35% for illegal migration and returns. Member States must allocate at least 15% of their allocation to the asylum and legal migration and integration objectives. a minimum of 20% of the thematic facility should be assigned to the solidarity objective. Resettlement, humanitarian admission and relocation The fund grants lump sums to Member States for the following cases: \u20ac10,000 for each person admitted through resettlement, including family members; \u20ac6,000 for each person admitted through humanitarian admission, with the amount increased to \u20ac8,000 for vulnerable persons \u2014 family members may also be eligible; \u20ac10,000 for each applicant / beneficiary of international protection transferred from one Member State to another, including family members. Non-EU countries The fund can support actions in or in relation to non-EU countries if they: contribute to the fund\u2019s objectives;are not development-oriented;are coordinated with other EU actions; andare consistent with the EU\u2019s priorities and external policy. Specific actions concerning cooperation with non-EU countries and reintegration assistance can be supported through the thematic facility. Non-EU countries can also be associated with the fund, subject to specific guarantees and agreements. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND For more information, see: Asylum, Migration and Integration Fund (European Commission). MAIN DOCUMENT Regulation (EU) 2021/1147 of the European Parliament and of the Council of 7 July 2021 establishing the Asylum, Migration and Integration Fund (OJ L 251, 15.7.2021, pp. 1-47) RELATED DOCUMENTS Regulation (EU) 2021/1148 of the European Parliament and of the Council of 7 July 2021 establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy (OJ L 251, 15.7.2021, pp. 48-93) Regulation (EU) 2021/1149 of the European Parliament and of the Council of 7 July 2021 establishing the Internal Security Fund (OJ L 251, 15.7.2021, pp. 94-131) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, pp. 98-107) Council Decision 2008/381/EC of 14 May 2008 establishing a European Migration Network (OJ L 131, 21.5.2008, pp. 7-12) Successive amendments to Council Decision 2008/381/EC have been incorporated in the original text. This consolidated version is of documentary value only. last update 27.09.2021"}
{"article": "12.7.2019 EN Official Journal of the European Union L 188/79 DIRECTIVE (EU) 2019/1158 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on work-life balance for parents and carers and repealing Council Directive 2010/18/EU THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular point (b) of Article 153(2), in conjunction with point (i) of Article 153(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Point (i) of Article 153(1) of the Treaty on the Functioning of the European Union (TFEU) provides that the Union is to support and complement the activities of the Member States in the area of equality between men and women with regard to labour market opportunities and treatment at work. (2) Equality between men and women is a fundamental principle of the Union. The second subparagraph of Article 3(3) of the Treaty on European Union (TEU) provides that the Union is to promote equality between women and men. Similarly, Article 23 of the Charter of Fundamental Rights of the European Union (Charter) requires equality between men and women to be ensured in all areas, including employment, work and pay. (3) Article 33 of the Charter provides for the right to protection from dismissal for a reason connected with maternity and the right to paid maternity leave and to parental leave following the birth or adoption of a child, to reconcile family and professional life. (4) The Union has ratified the 2006 United Nations Convention on the Rights of Persons with Disabilities. That Convention is thus an integral part of the Union legal order, and Union legal acts must, as far as possible, be interpreted in a manner that is consistent with the Convention. The Convention provides, in particular in Article 7(1), that parties thereto are to take all necessary measures to ensure the full enjoyment by children with disabilities of all human rights and fundamental freedoms on an equal basis with other children. (5) The Member States have ratified the 1989 United Nations Convention on the Rights of the Child. Article 18(1) of the Convention provides that both parents have common responsibilities for the upbringing and development of the child and that the best interests of the child should be the parents' basic concern. (6) Work-life balance policies should contribute to the achievement of gender equality by promoting the participation of women in the labour market, the equal sharing of caring responsibilities between men and women, and the closing of the gender gaps in earnings and pay. Such policies should take into account demographic changes including the effects of an ageing population. (7) In light of the challenges that arise from demographic change, together with the resultant pressure on public expenditure in some Member States, the need for informal care is expected to increase. (8) At Union level, several directives in the areas of gender equality and working conditions already address certain issues that are relevant for work-life balance, in particular Directives 2006/54/EC (4) and 2010/41/EU (5) of the European Parliament and of the Council, and Council Directives 92/85/EEC (6), 97/81/EC (7) and 2010/18/EU (8). (9) The principles of gender equality and work-life balance are reaffirmed in Principles 2 and 9 of the European Pillar of Social Rights, which was proclaimed by the European Parliament, the Council and the Commission on 17 November 2017. (10) However, work-life balance remains a considerable challenge for many parents and workers with caring responsibilities, in particular because of the increasing prevalence of extended working hours and changing work schedules, which has a negative impact on women's employment. A major factor contributing to the underrepresentation of women in the labour market is the difficulty of balancing work and family obligations. When they have children, women are likely to work fewer hours in paid employment and to spend more time fulfilling unpaid caring responsibilities. Having a sick or dependent relative has also been shown to have a negative impact on women's employment and results in some women dropping out of the labour market entirely. (11) The current Union legal framework provides limited incentives for men to assume an equal share of caring responsibilities. The lack of paid paternity and parental leave in many Member States contributes to the low take-up of leave by fathers. The imbalance in the design of work-life balance policies between women and men reinforces gender stereotypes and differences between work and care. Policies on equal treatment should aim to address the issue of stereotypes in both men's and women's occupations and roles, and the social partners are encouraged to act upon their key role in informing both workers and employers and raising their awareness of tackling discrimination. Furthermore, the use of work-life balance arrangements by fathers, such as leave or flexible working arrangements, has been shown to have a positive impact in reducing the relative amount of unpaid family work undertaken by women and leaving them more time for paid employment. (12) In implementing this Directive, Member States should take into consideration that the equal uptake of family-related leave between men and women also depends on other appropriate measures, such as the provision of accessible and affordable childcare and long-term care services, which are crucial for the purpose of allowing parents, and other persons with caring responsibilities to enter, remain in, or return to the labour market. Removing economic disincentives can also encourage second earners, the majority of whom are women, to participate fully in the labour market. (13) In order to assess the impact of this Directive, the Commission and the Member States should continue to cooperate with one another in order to develop comparable statistics that are disaggregated by sex. (14) The Commission has consulted management and labour in a two-stage process with regard to challenges related to work-life balance, in accordance with Article 154 TFEU. There was no agreement among the social partners to enter into negotiations with regard to those matters, including with regard to parental leave. It is, however, important to take action in that area by modernising and adapting the current legal framework, taking into account the outcome of those consultations, as well as of the public consultation carried out to seek the views of stakeholders and citizens. (15) Directive 2010/18/EU regulates parental leave by putting into effect a framework agreement concluded between the social partners. This Directive builds on the rules laid down in Directive 2010/18/EU and complements them by strengthening existing rights and by introducing new rights. Directive 2010/18/EU should be repealed and replaced by this Directive. (16) This Directive lays down minimum requirements related to paternity leave, parental leave and carers' leave, and to flexible working arrangements for workers who are parents, or carers. By facilitating the reconciliation of work and family life for such parents and carers, this Directive should contribute to the Treaty-based goals of equality between men and women with regard to labour market opportunities, equal treatment at work and the promotion of a high level of employment in the Union. (17) This Directive applies to all workers who have employment contracts or other employment relationships, including contracts relating to the employment or the employment relationships of part-time workers, fixed-term contract workers or persons with a contract of employment or employment relationship with a temporary agency, as previously provided for by Directive 2010/18/EU. Taking into account the case-law of the Court of Justice of the European Union (Court of Justice) regarding the criteria for determining the status of a worker, it is for Member States to define employment contracts and employment relationships. (18) Member States have the competence to define marital and family status, as well as to establish which persons are to be considered to be a parent, a mother and a father. (19) In order to encourage a more equal sharing of caring responsibilities between women and men, and to allow for the early creation of a bond between fathers and children, a right to paternity leave for fathers or, where and insofar as recognised by national law, for equivalent second parents, should be introduced. Such paternity leave should be taken around the time of the birth of the child and should be clearly linked to the birth for the purposes of providing care. Member States are also able to grant paternity leave in the case of a stillbirth. It is for Member States to determine whether to allow part of the paternity leave to be taken before the birth of the child or to require all of it to be taken thereafter, the time frame within which paternity leave is to be taken, and whether and under which conditions to allow paternity leave to be taken on a part-time basis, in alternating periods, such as for a number of consecutive days of leave separated by periods of work, or in other flexible ways. Member States are able to specify whether paternity leave is expressed in working days, weeks or other time units, taking into account that ten working days correspond to two calendar weeks. In order to take account of differences between Member States, the right to paternity leave should be granted irrespective of marital or family status, as defined by national law. (20) As most fathers do not avail themselves of their right to parental leave, or transfer a considerable proportion of their leave entitlement to mothers, this Directive extends from one to two months the minimum period of parental leave which cannot be transferred from one parent to the other in order to encourage fathers to take parental leave, while maintaining the right of each parent to take at least four months of parental leave as provided for in Directive 2010/18/EU. The purpose of ensuring that at least two months of parental leave is available to each parent exclusively and that cannot be transferred to the other parent, is to encourage fathers to make use of their right to such leave. It also promotes and facilitates the reintegration of mothers in the labour market after they have taken a period of maternity and parental leave. (21) A minimum period of four months of parental leave is guaranteed under this Directive to workers who are parents. Member States are encouraged to grant the right to parental leave to all workers who exercise parental responsibilities in accordance with national legal systems. (22) Member States should be able to specify the period of notice to be given by the worker to the employer when applying for parental leave and should be able to decide whether the right to parental leave is subject to a certain period of service. In view of the growing diversity of contractual arrangements, the sum of successive fixed-term contracts with the same employer should be taken into account for the purpose of calculating such a period of service. To balance the needs of workers with those of employers, Member States should also be able to decide whether to allow employers to postpone the granting of parental leave under certain circumstances, subject to the requirement that the employers should provide reasons for such a postponement in writing. (23) Given that flexibility makes it more likely that each parent, in particular fathers, will take up their entitlement to parental leave, workers should be able to request that parental leave be granted on a full-time or a part-time basis, in alternating periods, such as for a number of consecutive weeks of leave separated by periods of work, or in other flexible ways. The employer should be able to accept or refuse such a request for parental leave in ways other than on a full-time basis. Member States should assess whether the conditions of access to and the detailed arrangements for parental leave should be adapted to the specific needs of parents in particularly disadvantaged situations. (24) The period within which workers should be entitled to take parental leave should be linked to the age of the child. That age should be set in such a way as to enable both parents to effectively take up their full entitlement to parental leave under this Directive. (25) In order to facilitate the return to work following a period of parental leave, workers and employers are encouraged to maintain voluntary contact during the period of leave and can make arrangements for any appropriate measures to facilitate reintegration into the work place. Such contact and arrangements are to be decided between the parties concerned, taking into account national law, collective agreements or practice. Workers should be informed of promotion processes and internal vacancies and should be able to participate in such processes and to apply for such vacancies. (26) Studies demonstrate that Member States that provide a significant portion of parental leave to fathers and that pay the worker a payment or allowance during that leave at a relatively high replacement rate, experience a higher take-up rate by fathers and a positive trend in the rate of employment of mothers. It is therefore appropriate to allow such systems to continue provided that they meet certain minimum criteria, instead of providing the payment or allowance for paternity leave as provided for in this Directive. (27) In order to provide men and women with caring responsibilities with greater opportunities to remain in the workforce, each worker should have the right to carers' leave of five working days per year. Member States may decide that such leave can be taken in periods of one or more working days per case. In order to take account of divergent national systems, Member States should be able to allocate carers' leave on the basis of a period other than a year, by reference to the person in need of care or support, or by case. A continued rise in care needs is predicted, because of an ageing population and, consequentially, the concomitant increase in the prevalence of age-related impairments. The rise in care needs should be taken into account by Member States when they develop their care policies, including with regard to carers' leave. Member States are encouraged to make the right to carers' leave available with regard to additional relatives, such as grandparents and siblings. Member States can require prior medical certification of the need for significant care or support for a serious medical reason. (28) In addition to the right to carers' leave provided for in this Directive, all workers should retain their right to take time off from work without the loss of employment rights that have been acquired or that are in the process of being acquired, on the grounds of force majeure for urgent and unexpected family reasons, as provided for in Directive 2010/18/EU, in accordance with the conditions established by the Member States. (29) To increase incentives to workers who are parents, and to men in particular, to take the periods of leave provided for in this Directive, workers should be provided with a right to an adequate allowance while on leave. (30) Member States should therefore set a level for the payment or allowance with respect to the minimum period of paternity leave that is at least equivalent to the level of national sick pay. Since granting rights to paternity and maternity leave pursue similar objectives, namely creating a bond between the parent and the child, Member States are encouraged to provide for a payment or an allowance for paternity leave that is equal to the payment or allowance provided for maternity leave at national level. (31) Member States should set the payment or allowance for the minimum non-transferable period of parental leave guaranteed under this Directive at an adequate level. When setting the level of the payment or allowance provided for the minimum non-transferable period of parental leave, Member States should take into account that the take-up of parental leave often results in a loss of income for the family and that first earners in a family are able to make use of their right to parental leave only if it is sufficiently well remunerated, with a view to allowing for a decent living standard. (32) Although Member States are free to decide whether to provide a payment or an allowance for carers' leave, they are encouraged to introduce such a payment or an allowance in order to guarantee the effective take-up of the right by carers, in particular by men. (33) This Directive is without prejudice to the coordination of social security systems under Regulations (EC) No 883/2004 (9) and (EU) No 1231/2010 (10) of the European Parliament and of the Council and Council Regulation (EC) No 859/2003 (11). The Member State competent for the social security of a worker is determined by those Regulations. (34) In order to encourage workers who are parents, and carers to remain in the work force, such workers should be able to adapt their working schedules to their personal needs and preferences. To that end and with a focus on workers' needs, they have the right to request flexible working arrangements for the purpose of adjusting their working patterns, including, where possible, through the use of remote working arrangements, flexible working schedules, or a reduction in working hours, for the purposes of providing care. (35) In order to address the needs of both workers and employers, it should be possible for Member States to limit the duration of flexible working arrangements, including any reduction in working hours or any remote working arrangements. While working part-time has been shown to be useful in allowing some women to remain in the labour market after having children or caring for relatives with care or support needs, long periods of reduced working hours can lead to lower social security contributions and thus reduced or non-existing pension entitlements. (36) When considering requests for flexible working arrangements, employers should be able to take into account, inter alia, the duration of the flexible working arrangements requested and the employers' resources and operational capacity to offer such arrangements. The employer should be able to decide whether to accept or refuse a worker's request for flexible working arrangements. Specific circumstances underlying the need for flexible working arrangements can change. Workers should therefore have the right not only to return to their original working pattern at the end of a mutually agreed period, but should also be able to request to do so earlier where required on the basis of a change in the underlying circumstances. (37) Notwithstanding the requirement to assess whether the conditions of access to and the detailed arrangements for parental leave should be adapted to the specific needs of parents in particularly disadvantaged situations, Member States are encouraged to assess whether conditions for access to, and the detailed arrangements for, exercising the right to paternity leave, carers' leave and flexible working arrangements should be adapted to particular needs, such as of those of single parents, adoptive parents, parents with a disability, parents of children with a disability or a long-term illness, or parents in particular circumstances, such as those related to multiple births and premature births. (38) Leave arrangements are intended to support workers who are parents, and carers during a specific period of time, and aim to maintain and promote the workers' continued attachment to the labour market. It is therefore appropriate to make express provision for the protection of the employment rights of workers who take the types of leave covered by this Directive. In particular, this Directive protects the right of workers to return to the same or to an an equivalent post after taking such leave and the right not to be subject to any detriment in the terms and conditions of their contract of employment or employment relationship as a result of taking such leave. Workers should retain their entitlement to relevant rights that are already acquired, or that are in the process of being acquired, until the end of such leave. (39) As provided for in Directive 2010/18/EU, Member States are required to define the status of the employment contract or employment relationship for the period of parental leave. According to the case-law of the Court of Justice, the employment relationship between the worker and the employer is maintained during the period of leave and, as a result, the beneficiary of such leave remains, during that period, a worker for the purposes of Union law. When defining the status of the employment contract or employment relationship during the period of the types of leave covered by this Directive, including with regard to the entitlement to social security, the Member States should therefore ensure that the employment relationship is maintained. (40) Workers who exercise their right to take leave or to request flexible working arrangements as provided for in this Directive should be protected against discrimination or any less favourable treatment on that ground. (41) Workers who exercise their right to take leave or to request flexible working arrangements as provided for in this Directive should enjoy protection from dismissal and any preparatory steps for a possible dismissal on the grounds that they have applied for, or have taken, such leave or that they have exercised their right to request such flexible working arrangements in accordance with the case law of the Court of Justice, including its judgment in Case C-460/06 (12). Workers who consider that they have been dismissed on the basis that they have exercised such rights should be able to ask the employer to provide duly substantiated grounds for the dismissal. Where a worker has applied for, or has taken, paternity leave, parental leave or carers' leave as referred to in this Directive, the employer should provide the grounds for dismissal in writing. (42) The burden of proving that there has been no dismissal on the grounds that workers have applied for, or have taken, paternity leave, parental leave or carers' leave as referred to in this Directive should be on the employer where a worker has established, before a court or another competent authority, facts capable of giving rise to a presumption that the worker has been dismissed on such grounds. (43) Member States should provide for effective, proportionate and dissuasive penalties in the event of infringements of national provisions adopted pursuant to this Directive or national provisions that are already in force on the date of entry into force of this Directive and that relate to the rights which are within its scope. Such penalties can include administrative and financial penalties, such as fines or the payment of compensation, as well as other types of penalties. (44) The effective implementation of the principles of equal treatment and equal opportunities requires the adequate judicial protection of workers against adverse treatment or adverse consequences resulting from a complaint or from proceedings relating to the rights under this Directive. It is possible that victims are deterred from exercising their rights on account of the risk of retaliation and therefore should be protected from any adverse treatment where they exercise their rights provided for in this Directive. Such protection is particularly relevant as regards the representatives of workers in the exercise of their functions. (45) With a view to further improving the level of protection of the rights provided for in this Directive, national equality bodies should be competent in regard to issues relating to discrimination that fall within the scope of this Directive, including the task of providing independent assistance to victims of discrimination in pursuing their complaints. (46) This Directive lays down minimum requirements, thus giving the Member States the option of introducing or maintaining provisions that are more favourable to workers. Allowing one parent to transfer to the other parent more than two months out of the four months of parental leave provided for in this Directive does not constitute a provision that is more favourable to the worker than the minimum provisions laid down in this Directive. Rights that are already acquired on the date of entry into force of this Directive should continue to apply unless this Directive provides for more favourable provisions. The implementation of this Directive should neither be used to reduce existing Union law rights, nor constitute valid grounds for reducing the general level of protection provided to workers, in the areas covered by this Directive. (47) In particular, nothing in this Directive should be interpreted as reducing the rights provided for in Directives 2010/18/EU, 92/85/EEC and 2006/54/EC, including Article 19 of Directive 2006/54/EC. (48) Micro, small and medium-sized enterprises (SMEs) as defined in the Annex to Commission Recommendation 2003/361/EC (13), which represent the large majority of enterprises in the Union, can have limited financial, technical and human resources. In implementing this Directive, Member States should strive to avoid imposing administrative, financial or legal constraints in a manner which would amount to a disincentive to the creation and development of SMEs or an excessive burden to employers. Member States are therefore invited to thoroughly assess the impact of their implementing measures on SMEs in order to ensure the equal treatment of all workers, that SMEs are not disproportionately affected by the measures, with particular focus on microenterprises, and that any unnecessary administrative burden is avoided. Member States are encouraged to provide incentives, guidance and advice to SMEs to assist them in complying with their obligations pursuant to this Directive. (49) Any kind of family-related time off work, in particular maternity leave, paternity leave, parental leave and carers' leave, that is available under national law or collective agreements should count towards fulfilling the requirements of one or more of the types of leave provided for in this Directive and in Directive 92/85/EEC, provided that the minimum requirements of those directives are fulfilled and that the general level of protection provided to workers in the areas covered by them is not reduced. In implementing this Directive, Member States are not required to rename or otherwise change the different types of family-related leave that are provided for under national law or collective agreements and which count towards compliance with this Directive. (50) Member States are encouraged, in accordance with national practice, to promote a social dialogue with the social partners with a view to fostering the reconciliation of work and private life, including by promoting work-life balance measures in the workplace, establishing voluntary certification systems, providing vocational training, raising awareness, and carrying out information campaigns. In addition, Member States are encouraged to engage in a dialogue with relevant stakeholders, such as non-governmental organisations, local and regional authorities and service providers, in order to promote work-life balance policies in accordance with national law and practice. (51) The social partners should be encouraged to promote voluntary certification systems assessing work-life balance at the workplace. (52) Since the objectives of this Directive, namely to ensure the implementation of the principle of equality between men and women with regard to labour market opportunities and treatment at work across the Union, cannot be sufficiently achieved by the Member States, but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS DIRECTIVE: Article 1 Subject matter This Directive lays down minimum requirements designed to achieve equality between men and women with regard to labour market opportunities and treatment at work, by facilitating the reconciliation of work and family life for workers who are parents, or carers. To that end, this Directive provides for individual rights related to the following: (a) paternity leave, parental leave and carers' leave; (b) flexible working arrangements for workers who are parents, or carers. Article 2 Scope This Directive applies to all workers, men and women, who have an employment contract or employment relationship as defined by the law, collective agreements or practice in force in each Member State, taking into account the case-law of the Court of Justice. Article 3 Definitions 1. For the purposes of this Directive, the following definitions apply: (a) \u2018paternity leave\u2019 means leave from work for fathers or, where and insofar as recognised by national law, for equivalent second parents, on the occasion of the birth of a child for the purposes of providing care; (b) \u2018parental leave\u2019 means leave from work for parents on the grounds of the birth or adoption of a child to take care of that child; (c) \u2018carers' leave\u2019 means leave from work for workers in order to provide personal care or support to a relative, or to a person who lives in the same household as the worker, and who is in need of significant care or support for a serious medical reason, as defined by each Member State; (d) \u2018carer\u2019 means a worker providing personal care or support to a relative, or to a person who lives in the same household as the worker, and who is in need of significant care or support for a serious medical reason, as defined by each Member State; (e) \u2018relative\u2019 means a worker's son, daughter, mother, father, spouse or, where such partnerships are recognised by national law, partner in civil partnership; (f) \u2018flexible working arrangements\u2019 means the possibility for workers to adjust their working patterns, including through the use of remote working arrangements, flexible working schedules, or reduced working hours. 2. The reference to working days in Articles 4 and 6 shall be understood as referring to the full-time working pattern, as defined in the Member State in question. A worker's entitlement to leave may be calculated proportionally to the worker's working time, in accordance with the working pattern specified in the worker's contract of employment or employment relationship. Article 4 Paternity leave 1. Member States shall take the necessary measures to ensure that fathers or, where and insofar as recognised by national law, equivalent second parents, have the right to paternity leave of 10 working days that is to be taken on the occasion of the birth of the worker's child. Member States may determine whether to allow paternity leave to be taken partly before or only after the birth of the child and whether to allow such leave to be taken in flexible ways. 2. The right to paternity leave shall not be made subject to a period of work qualification or to a length of service qualification. 3. The right to paternity leave shall be granted irrespective of the worker's marital or family status, as defined by national law. Article 5 Parental leave 1. Member States shall take the necessary measures to ensure that each worker has an individual right to parental leave of four months that is to be taken before the child reaches a specified age, up to the age of eight, to be specified by each Member State or by collective agreement. That age shall be determined with a view to ensuring that each parent is able to exercise their right to parental leave effectively and on an equal basis. 2. Member States shall ensure that two months of parental leave cannot be transferred. 3. Member States shall establish a reasonable period of notice that is to be given by workers to employers where they exercise their right to parental leave. In doing so, Member States shall take into account the needs of both the employers and the workers. Member States shall ensure that the worker's request for parental leave specifies the intended beginning and end of the period of leave. 4. Member States may make the right to parental leave subject to a period of work qualification or to a length of service qualification, which shall not exceed one year. In the case of successive fixed-term contracts within the meaning of Council Directive 1999/70/EC (14) with the same employer, the sum of those contracts shall be taken into account for the purpose of calculating the qualifying period. 5. Member States may establish the circumstances in which an employer, following consultation in accordance with national law, collective agreements or practice, is allowed to postpone the granting of parental leave for a reasonable period of time on the grounds that the taking of parental leave at the time requested would seriously disrupt the good functioning of the employer. Employers shall provide reasons for such a postponement of parental leave in writing. 6. Member States shall take the necessary measures to ensure that workers have the right to request that they take parental leave in flexible ways. Member States may specify the modalities of application thereof. The employer shall consider and respond to such requests, taking into account the needs of both the employer and the worker. The employer shall provide reasons for any refusal to accede to such a request in writing within a reasonable period after the request. 7. Member States shall take the necessary measures to ensure that when considering requests for full-time parental leave, employers shall, prior to any postponement in accordance with paragraph 5, offer, to the extent possible, flexible ways of taking parental leave pursuant to paragraph 6. 8. Member States shall assess the need for the conditions of access to and the detailed arrangements for the application of parental leave to be adapted to the needs of adoptive parents, parents with a disability and parents with children with a disability or a long-term illness. Article 6 Carers' leave 1. Member States shall take the necessary measures to ensure that each worker has the right to carers' leave of five working days per year. Member States may determine additional details regarding the scope and conditions of carers' leave in accordance with national law or practice. The use of that right may be subject to appropriate substantiation, in accordance with national law or practice. 2. Member States may allocate carers' leave on the basis of a reference period other than a year, per person in need of care or support, or per case. Article 7 Time off from work on grounds of force majeure Member States shall take the necessary measures to ensure that each worker has the right to time off from work on grounds of force majeure for urgent family reasons in the case of illness or accident making the immediate attendance of the worker indispensable. Member States may limit the right of each worker to time off from work on grounds of force majeure to a certain amount of time each year or by case, or both. Article 8 Payment or allowance 1. In accordance with national circumstances, such as national law, collective agreements or practice, and taking into account the powers delegated to the social partners, Member States shall ensure that workers who exercise their right to leave provided for in Article 4(1) or Article 5(2) receive a payment or an allowance in accordance with paragraphs 2 and 3 of this Article. 2. With regard to paternity leave as referred to in Article 4(1), such payment or allowance shall guarantee an income at least equivalent to that which the worker concerned would receive in the event of a break in the worker's activities on grounds connected with the worker's state of health, subject to any ceiling laid down in national law. Member States may make the right to a payment or an allowance subject to periods of previous employment, which shall not exceed six months immediately prior to the expected date of the birth of the child. 3. With regard to parental leave as referred to in Article 5(2), such payment or allowance shall be defined by the Member State or the social partners and shall be set in such a way as to facilitate the take-up of parental leave by both parents. Article 9 Flexible working arrangements 1. Member States shall take the necessary measures to ensure that workers with children up to a specified age, which shall be at least eight years, and carers, have the right to request flexible working arrangements for caring purposes. The duration of such flexible working arrangements may be subject to a reasonable limitation. 2. Employers shall consider and respond to requests for flexible working arrangements as referred to in paragraph 1 within a reasonable period of time, taking into account the needs of both the employer and the worker. Employers shall provide reasons for any refusal of such a request or for any postponement of such arrangements. 3. When flexible working arrangements as referred to in paragraph 1 are limited in duration, the worker shall have the right to return to the original working pattern at the end of the agreed period. The worker shall also have the right to request to return to the original working pattern before the end of the agreed period where justified on the basis of a change of circumstances. The employer shall consider and respond to a request for an early return to the original working pattern, taking into account the needs of both the employer and the worker. 4. Member States may make the right to request flexible working arrangements subject to a period of work qualification or to a length of service qualification, which shall not exceed six months. In the case of successive fixed-term contracts within the meaning of Directive 1999/70/EC with the same employer, the sum of those contracts shall be taken into account for the purpose of calculating the qualifying period. Article 10 Employment rights 1. Rights that have been acquired or that are in the process of being acquired by workers on the date on which leave provided for in Articles 4, 5 and 6 or time off from work provided for in Article 7 starts shall be maintained until the end of such leave or time off from work. At the end of such leave or time off from work, those rights, including any changes arising from national law, collective agreements or practice, shall apply. 2. Member States shall ensure that, at the end of leave provided for in Articles 4, 5 and 6, workers are entitled to return to their jobs or to equivalent posts on terms and conditions which are no less favourable to them, and to benefit from any improvement in working conditions to which they would have been entitled had they not taken the leave. 3. Member States shall define the status of the employment contract or employment relationship for the period of leave provided for in Articles 4, 5 and 6, or time off from work provided for in Article 7, including as regards entitlements to social security, including pension contributions, while ensuring that the employment relationship is maintained during that period. Article 11 Discrimination Member States shall take the necessary measures to prohibit less favourable treatment of workers on the ground that they have applied for, or have taken, leave provided for in Articles 4, 5 and 6 or time off from work provided for in Article 7, or that they have exercised the rights provided for in Article 9. Article 12 Protection from dismissal and burden of proof 1. Member States shall take the necessary measures to prohibit the dismissal and all preparations for the dismissal of workers, on the grounds that they have applied for, or have taken, leave provided for in Articles 4, 5 and 6, or have exercised the right to request flexible working arrangements referred to in Article 9. 2. Workers who consider that they have been dismissed on the grounds that they have applied for, or have taken, leave provided for in Articles 4, 5 and 6, or have exercised the right to request flexible working arrangements as referred to in Article 9, may request the employer to provide duly substantiated reasons for their dismissal. With respect to the dismissal of a worker who has applied for, or has taken, leave provided for in Article 4, 5 or 6, the employer shall provide reasons for the dismissal in writing. 3. Member States shall take the measures necessary to ensure that where workers who consider that they have been dismissed on the grounds that they have applied for, or have taken, leave provided for in Articles 4, 5 and 6 establish, before a court or other competent authority, facts capable of giving rise to a presumption that they have been dismissed on such grounds, it shall be for the employer to prove that the dismissal was based on other grounds. 4. Paragraph 3 shall not prevent Member States from introducing rules of evidence which are more favourable to workers. 5. Member States shall not be required to apply paragraph 3 to proceedings in which it is for the court or competent body to investigate the facts of the case. 6. Paragraph 3 shall not apply to criminal proceedings, unless otherwise provided by the Member States. Article 13 Penalties Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive, or the relevant provisions already in force concerning the rights which are within the scope of this Directive, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Article 14 Protection against adverse treatment or consequences Member States shall introduce measures necessary to protect workers, including workers who are employees' representatives, from any adverse treatment by the employer or adverse consequences resulting from a complaint lodged within the undertaking or any legal proceedings for the purpose of enforcing compliance with the requirements laid down in this Directive. Article 15 Equality bodies Without prejudice to the competence of labour inspectorates or other bodies that enforce the rights of workers, including the social partners, Member States shall ensure that the body or bodies designated, pursuant to Article 20 of Directive 2006/54/EC, for the promotion, analysis, monitoring and support of equal treatment of all persons without discrimination on grounds of sex, are competent with regard to issues relating to discrimination falling within the scope of this Directive. Article 16 Level of protection 1. Member States may introduce or maintain provisions that are more favourable to workers than those laid down in this Directive. 2. The implementation of this Directive shall not constitute grounds for justifying a reduction in the general level of protection of workers in the areas covered by this Directive. The prohibition of such a reduction in the level of protection shall be without prejudice to the right of Member States and the social partners to lay down, in light of changing circumstances, legislative, regulatory or contractual arrangements other than those in force on 1 August 2019, provided that the minimum requirements laid down in this Directive are complied with. Article 17 Dissemination of information Member States shall ensure that the national measures transposing this Directive, together with the relevant provisions already in force relating to the subject matter as set out in Article 1, are brought to the attention of workers and employers, including employers that are SMEs, by all appropriate means throughout their territory. Article 18 Reporting and review 1. By 2 August 2027, Member States shall communicate to the Commission all information concerning the implementation of this Directive that is necessary for the Commission to draw up a report. That information shall include available aggregated data on the take-up of different types of leave and flexible working arrangements, by men and women pursuant to this Directive, for the purposes of allowing the proper monitoring and assessment of the implementation of this Directive, in particular with regard to gender equality. 2. The Commission shall submit the report referred to in paragraph 1 to the European Parliament and to the Council. The report shall, if appropriate, be accompanied by a legislative proposal. The report shall also be accompanied by: (a) a study of the interaction between the different types of leave provided for in this Directive as well as other types of family-related leave, such as adoption leave; and (b) a study of the rights to family-related leave that are granted to self-employed persons. Article 19 Repeal 1. Directive 2010/18/EU is repealed with effect from 2 August 2022. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in the Annex. 2 Notwithstanding the repeal of Directive 2010/18/EU pursuant to paragraph 1 of this Article, any period or separate cumulative periods of parental leave taken or transferred by a worker pursuant to that Directive before 2 August 2022 may be deducted from that worker's parental leave entitlement under Article 5 of this Directive. Article 20 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 2 August 2022. They shall immediately inform the Commission thereof. 2. Notwithstanding paragraph 1 of this Article, for the payment or allowance corresponding to the last two weeks of parental leave as provided for in Article 8(3), Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 2 August 2024. They shall immediately inform the Commission thereof. 3. When Member States adopt the measures referred to in paragraphs 1 and 2, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 4. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the areas covered by this Directive. 5. The detailed rules and modalities for applying this Directive shall be established in accordance with national law, collective agreements or practice, as long as the minimum requirements and the objectives of this Directive are respected. 6. For the purposes of complying with Articles 4, 5, 6 and 8 of this Directive and with Directive 92/85/EEC, Member States may take into account any period of, and payment or allowance with respect to, family-related time off work, in particular maternity leave, paternity leave, parental leave and carers' leave, available at national level which is above the minimum standards provided for in this Directive or in Directive 92/85/EEC, provided that the minimum requirements for such leave are met and that the general level of protection provided to workers in the areas covered by those Directives is not reduced. 7. Where Member States ensure a payment or an allowance of at least 65 % of the worker's net wage, which may be subject to a ceiling, for at least six months of parental leave for each parent, they may decide to maintain such system rather than provide for the payment or allowance referred to in Article 8(2). 8. Member States may entrust the social partners with the implementation of this Directive, where the social partners jointly request to do so, provided that Member States take all the necessary steps to ensure that the results sought by this Directive are guaranteed at all times. Article 21 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 22 Addressees This Directive is addressed to the Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 129, 11.4.2018, p. 44. (2) OJ C 164, 8.5.2018, p. 62. (3) Position of the European Parliament of 4 April 2019 (not yet published in the Official Journal) and decision of the Council of 13 June 2019. (4) Directive 2006/54/EC of the European Parliament and of the Council of 5 July 2006 on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation (OJ L 204, 26.7.2006, p. 23). (5) Directive 2010/41/EU of the European Parliament and of the Council of 7 July 2010 on the application of the principle of equal treatment between men and women engaged in an activity in a self-employed capacity and repealing Council Directive 86/613/EEC (OJ L 180, 15.7.2010, p. 1). (6) Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (OJ L 348, 28.11.1992, p. 1). (7) Council Directive 97/81/EC of 15 December 1997 concerning the Framework Agreement on part-time work concluded by UNICE, CEEP and the ETUC (OJ L 14, 20.1.1998, p. 9). (8) Council Directive 2010/18/EU of 8 March 2010 implementing the revised Framework Agreement on parental leave concluded by BUSINESSEUROPE, UEAPME, CEEP and ETUC and repealing Directive 96/34/EC (OJ L 68, 18.3.2010, p. 13). (9) Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ L 166, 30.4.2004, p. 1). (10) Regulation (EU) No 1231/2010 of the European Parliament and of the Council of 24 November 2010 extending Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 to nationals of third countries who are not already covered by these Regulations solely on the ground of their nationality (OJ L 344, 29.12.2010, p. 1). (11) Council Regulation (EC) No 859/2003 of 14 May 2003 extending the provisions of Regulation (EEC) No 1408/71 and Regulation (EEC) No 574/72 to nationals of third countries who are not already covered by those provisions solely on the ground of their nationality (OJ L 124, 20.5.2003, p. 1). (12) Judgment of the Court of Justice of 11 October 2007, Nadine Paquay v Soci\u00e9t\u00e9 d'architectes Hoet + Minne SPRL, C-460/06, ECLI:EU:C:2007:601. (13) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (14) Council Directive 1999/70/EC of 28 June 1999 concerning the framework agreement on fixed-term work concluded by ETUC, UNICE and CEEP (OJ L 175, 10.7.1999, p. 43). ANNEX CORRELATION TABLE Directive 2010/18/EU This Directive Clause 1(1) Article 1 Clause 1(2) Article 2 Clause 1(3) Article 2 Clause 2(1) Article 5(1) Clause 2(2) Article 5(1) and (2) Clause 3(1)(a) Article 5(6) Clause 3(1)(b) Article 5(4) Clause 3(1)(c) Article 5(5) Clause 3(1)(d) \u2014 Clause 3(2) Article 5(3) Clause 3(3) Article 5(8) Clause 4(1) Article 5(8) Clause 5(1) Article 10(2) Clause 5(2) Article 10(1) Clause 5(3) Article 10(3) Clause 5(4) Article 11 Clause 5(5) first subparagraph Article 10(3) Clause 5(5) second subparagraph Article 8(3) Clause 6(1) Article 9 Clause 6(2) Recital 25 Clause 7(1) Article 7 Clause 7(2) Article 7 Clause 8(1) Article 16(1) Clause 8(2) Article 16(2) Clause 8(3) \u2014 Clause 8(4) \u2014 Clause 8(5) \u2014 Clause 8(6) \u2014 Clause 8(7) \u2014", "summary": "Work-life balance for parents and carers Work-life balance for parents and carers SUMMARY OF: Directive (EU) 2019/1158 on work-life balance for parents and carers WHAT IS THE AIM OF THE DIRECTIVE? It seeks to ensure gender equality with respect to labour market opportunities and treatment at work throughout the EU by facilitating the work-life balance for workers who are parents or carers. It sets out minimum requirements for family-related leaves (paternity, parental and carers\u2019 leave) and flexible working arrangements. It seeks to increase women\u2019s participation in the labour market and to achieve a better sharing of caring responsibilities between men and women. It creates incentives for men to assume an equal share of caring responsibilities by creating paid paternity and parental leave which is one of the reasons of the low take-up of leave by fathers. The imbalance in the design of work-life balance policies between women and men reinforces gender stereotypes and differences between work and care. Policies on equal treatment should aim to address the issue of stereotypes in both men's and women's occupations and roles. KEY POINTS Scope The directive relates to all men and women who have an employment contract or an employment relationship as defined by the law, collective agreements or practice in force in each EU country, taking into account the case-law of the Court of Justice of the EU. Minimum rights The directive provides for minimum individual rights related to the following: paternity leave, parental leave and carers\u2019 leave; flexible working arrangements for workers who are parents, or carers; and legal protection for those applying for or making use of family-related leave and flexible working arrangements. EU countries may choose to introduce or maintain rules that are more favourable to workers. Paternity leave Fathers or equivalent second parents have the right to take paternity leave of 10 working days on the birth of a child. Paternity leave has to be paid at the national sick pay level. The right to paternity leave must not be made subject to a period of work qualification or to a length of service qualification. EU countries may make the right to a payment or an allowance subject to periods of previous employment, which must not exceed 6 months immediately prior to the expected date of the birth of the child. Parental leave Each worker has an individual right to 4 months\u2019 paid parental leave, 2 months of which are non-transferable between the parents. At least 2 months of parental leave per parent need to be paid at an adequate level. EU countries may make the right to parental leave subject to a period of work qualification or to a length of service qualification, which must not exceed 1 year. EU countries must ensure that workers have the right to request that they take parental leave in a flexible way, such as on a part-time basis, or in alternating periods of leave separated by periods of work. Carers\u2019 leave The directive introduces rules for carers, namely workers caring for relatives requiring support due to serious medical reasons. These rules also cover care for a person who lives in the same household as the worker. Each carer is entitled to take 5 working days per year. Flexible working arrangements Workers with children up to a specified age, but at least 8, and carers have the right to request flexible working arrangements for caring purposes. These arrangements include the use of remote working arrangements, flexible working schedules, or a reduction in working hours. Employers must deal with these requests within a reasonable period of time and provide reasons for refusing or postponing such arrangements. EU countries may make the right to request flexible working arrangements subject to a period of work qualification or to a length of service qualification. This period must not exceed 6 months. Legal protection EU countries must introduce rules to ensure: workers are protected from discrimination and dismissal on the grounds that they have applied for, or have taken, family-related leave or flexible working arrangements; workers who consider that they have been dismissed on the basis that they have exercised such rights should be able to ask the employer to provide duly substantiated grounds for the dismissal; the previous job and the rights acquired or in the process of being acquired before leave by the worker are maintained after the leave. Repeal The directive repeals Directive 2010/18/EU on parental leave from 2 August 2022. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 1 August 2019 and has to become law in the EU countries by 2 August 2022 (except for the payment of the last 2 weeks of parental leave, for which the deadline is 2 August 2024). BACKGROUND For more information, see: Work-life balance (European Commission). MAIN DOCUMENT Directive (EU) 2019/1158 of the European Parliament and of the Council of 20 June 2019 on work-life balance for parents and carers and repealing Council Directive 2010/18/EU (OJ L 188, 12.7.2019, pp. 79-93) RELATED DOCUMENTS Council Directive 2010/18/EU of 8 March 2010 implementing the revised Framework Agreement on parental leave concluded by BUSINESSEUROPE, UEAPME, CEEP and ETUC and repealing Directive 96/34/EC (OJ L 68, 18.3.2010, pp. 13-20) Successive amendments to Directive 2010/18/EU have been incorporated into the original document. This consolidated version is of documentary value only. Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (OJ L 348, 28.11.1992, pp. 1-7) See consolidated version. last update 24.02.2020"}
{"article": "11.7.2019 EN Official Journal of the European Union L 186/105 DIRECTIVE (EU) 2019/1152 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on transparent and predictable working conditions in the European Union THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular point (b) of Article 153(2), in conjunction with point (b) of Article 153(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Article 31 of the Charter of Fundamental Rights of the European Union provides that every worker has the right to working conditions which respect his or her health, safety and dignity, to limitation of maximum working hours, to daily and weekly rest periods and to an annual period of paid leave. (2) Principle No 5 of the European Pillar of Social Rights, proclaimed at Gothenburg on 17 November 2017, provides that, regardless of the type and duration of the employment relationship, workers have the right to fair and equal treatment regarding working conditions, access to social protection and training, and that the transition towards open-ended forms of employment is to be fostered; that, in accordance with legislation and collective agreements, the necessary flexibility for employers to adapt swiftly to changes in the economic context is to be ensured; that innovative forms of work that ensure quality working conditions are to be fostered, that entrepreneurship and self-employment are to be encouraged and that occupational mobility is to be facilitated; and that employment relationships that lead to precarious working conditions are to be prevented, including by prohibiting abuse of atypical contracts, and that any probationary period is to be of a reasonable duration. (3) Principle No 7 of the European Pillar of Social Rights provides that workers have the right to be informed in writing at the start of employment about their rights and obligations resulting from the employment relationship, including any probationary period; that prior to any dismissal they are entitled to be informed of the reasons and given a reasonable period of notice; and that they have the right to access to effective and impartial dispute resolution and, in the case of unjustified dismissal, a right to redress, including adequate compensation. (4) Since the adoption of Council Directive 91/533/EEC (4), labour markets have undergone far-reaching changes due to demographic developments and digitalisation leading to the creation of new forms of employment, which have enhanced innovation, job creation and labour market growth. Some new forms of employment vary significantly from traditional employment relationships with regard to predictability, creating uncertainty with regard to the applicable rights and the social protection of the workers concerned. In this evolving world of work, there is therefore an increased need for workers to be fully informed about their essential working conditions, which should occur in a timely manner and in written form to which workers have easy access. In order adequately to frame the development of new forms of employment, workers in the Union should also be provided with a number of new minimum rights aiming to promote security and predictability in employment relationships while achieving upward convergence across Member States and preserving labour market adaptability. (5) Pursuant to Directive 91/533/EEC, the majority of workers in the Union have the right to receive written information about their working conditions. Directive 91/533/EEC does not however apply to all workers in the Union. Moreover, gaps in protection have emerged for new forms of employment created as a result of labour market developments since 1991. (6) Minimum requirements relating to information on the essential aspects of the employment relationship and relating to working conditions that apply to every worker should therefore be established at Union level in order to guarantee all workers in the Union an adequate degree of transparency and predictability as regards their working conditions, while maintaining reasonable flexibility of non-standard employment, thus preserving its benefits to workers and employers. (7) The Commission has undertaken a two-phase consultation with the social partners, in accordance with Article 154 of the Treaty on the Functioning of the European Union, on the improvement of the scope and effectiveness of Directive 91/533/EEC and the broadening of its objectives in order to establish new rights for workers. This did not result in an agreement among the social partners to enter into negotiations on those matters. However, as confirmed by the outcome of the open public consultations that sought the views of various stakeholders and citizens, it is important to take action at Union level in this area by modernising and adapting the current legal framework to new developments. (8) In its case law, the Court of Justice of the European Union (Court of Justice) has established criteria for determining the status of a worker (5). The interpretation of the Court of Justice of those criteria should be taken into account in the implementation of this Directive. Provided that they fulfil those criteria, domestic workers, on-demand workers, intermittent workers, voucher based-workers, platform workers, trainees and apprentices could fall within the scope of this Directive. Genuinely self-employed persons should not fall within the scope of this Directive since they do not fulfil those criteria. The abuse of the status of self-employed persons, as defined in national law, either at national level or in cross-border situations, is a form of falsely declared work that is frequently associated with undeclared work. Bogus self-employment occurs when a person is declared to be self-employed while fulfilling the conditions characteristic of an employment relationship, in order to avoid certain legal or fiscal obligations. Such persons should fall within the scope of this Directive. The determination of the existence of an employment relationship should be guided by the facts relating to the actual performance of the work and not by the parties\u2019 description of the relationship. (9) It should be possible for Member States to provide, where justified on objective grounds, for certain provisions of this Directive not to apply to certain categories of civil servants, public emergency services, the armed forces, police authorities, judges, prosecutors, investigators or other law enforcement services, given the specific nature of the duties that they are called on to perform or of their employment conditions. (10) The requirements laid down in this Directive with regard to the following matters should not apply to seafarers or sea fishermen, given the specificities of their employment conditions: parallel employment where incompatible with the work performed on board ships or fishing vessels, minimum predictability of work, the sending of workers to another Member State or to a third country, transition to another form of employment, and providing information on the identity of the social security institutions receiving the social contributions. For the purposes of this Directive, seafarers and sea fishermen as defined, respectively, in Council Directives 2009/13/EC (6) and (EU) 2017/159 (7) should be considered to be working in the Union when they work on board ships or fishing vessels registered in a Member State or flying the flag of a Member State. (11) In view of the increasing number of workers excluded from the scope of Directive 91/533/EEC on the basis of exclusions made by Member States under Article 1 of that directive, it is necessary to replace those exclusions with a possibility for Member States not to apply the provisions of this Directive to an employment relationship with predetermined and actual working hours that amount to an average of three hours per week or less in a reference period of four consecutive weeks. The calculation of those hours should include all time actually worked for an employer, such as overtime or work supplementary to that guaranteed or anticipated in the employment contract or employment relationship. From the moment when a worker crosses that threshold, the provisions of this Directive apply to him or her, regardless of the number of working hours that the worker works subsequently or the number of working hours provided for in the employment contract. (12) Workers who have no guaranteed working time, including those on zero-hour and some on-demand contracts, are in a particularly vulnerable situation. Therefore, the provisions of this Directive should apply to them regardless of the number of hours they actually work. (13) Several different natural or legal persons or other entities may in practice assume the functions and responsibilities of an employer. Member States should remain free to determine more precisely the persons who are considered to be wholly or partly responsible for the execution of the obligations that this Directive lays down for employers, as long as all those obligations are fulfilled. Member States should also be able to decide that some or all of those obligations are to be assigned to a natural or legal person who is not party to the employment relationship. (14) Member States should be able to establish specific rules to exclude individuals acting as employers for domestic workers in the household from the requirements laid down in this Directive, with regard to the following matters: to consider and respond to requests for different types of employment, to provide mandatory training that is free of cost, and to provide for redress mechanisms that are based on favourable presumptions in the case of information that is missing from the documentation that is to be provided to the worker under this Directive. (15) Directive 91/533/EEC introduced a list of essential aspects of the employment contract or employment relationship of which workers are to be informed in writing. It is necessary to adapt that list, which Member States can enlarge, in order to take account of developments in the labour market, in particular the growth of non-standard forms of employment. (16) Where the worker has no fixed or main place of work, he or she should receive information about arrangements, if any, for travel between the workplaces. (17) It should be possible for information on the training entitlement provided by the employer to take the form of information that includes the number of training days, if any, to which the worker is entitled per year, and information about the employer\u2019s general training policy. (18) It should be possible for information on the procedure to be observed by the employer and the worker if their employment relationship is terminated to include the deadline for bringing an action contesting dismissal. (19) Information on working time should be consistent with Directive 2003/88/EC of the European Parliament and of the Council (8), and should include information on breaks, daily and weekly rest periods and the amount of paid leave, thereby ensuring the protection of the safety and health of workers. (20) Information on remuneration to be provided should include all elements of the remuneration indicated separately, including, if applicable, contributions in cash or kind, overtime payments, bonuses and other entitlements, directly or indirectly received by the worker in respect of his or her work. The provision of such information should be without prejudice to the freedom for employers to provide for additional elements of remuneration such as one-off payments. The fact that elements of remuneration due by law or collective agreement have not been included in that information should not constitute a reason for not providing them to the worker. (21) If it is not possible to indicate a fixed work schedule because of the nature of the employment, such as in the case of an on-demand contract, employers should inform workers how their working time is to be established, including the time slots in which they may be called to work and the minimum notice period that they are to receive before the start of a work assignment. (22) Information on social security systems should include information on the identity of the social security institutions receiving the social security contributions, where relevant, with regard to sickness, maternity, paternity and parental benefits, benefits for accidents at work and occupational diseases, and old-age, invalidity, survivors\u2019, unemployment, pre-retirement and family benefits. Employers should not be required to provide that information where the worker chooses the social security institution. Information on the social security protection provided by the employer should include, where relevant, the fact of coverage by supplementary pension schemes within the meaning of Directive 2014/50/EU of the European Parliament and of the Council (9) and Council Directive 98/49/EC (10). (23) Workers should have the right to be informed about their rights and obligations resulting from the employment relationship in writing at the start of employment. The basic information should therefore reach them as soon as possible and at the latest within a calendar week from their first working day. The remaining information should reach them within one month from their first working day. The first working day should be understood to be the actual start of performance of work by the worker in the employment relationship. Member States should aim to have the relevant information on the employment relationship provided by the employers before the end of the initially agreed duration of the contract. (24) In light of the increasing use of digital communication tools, information that is to be provided in writing under this Directive can be provided by electronic means. (25) In order to help employers to provide timely information, Member States should be able to provide templates at national level including relevant and sufficiently comprehensive information on the legal framework applicable. Those templates could be further developed at sectoral or local level, by national authorities and the social partners. The Commission will support Member States in developing templates and models and make them widely available, as appropriate. (26) Workers sent abroad should receive additional information specific to their situation. For successive work assignments in several Member States or third countries, it should be possible for the information for several assignments to be collated before the first departure and subsequently modified in the case of any changes. Workers who qualify as posted workers under Directive 96/71/EC of the European Parliament and of the Council (11) should also be notified of the single official national website developed by the host Member State where they are able to find the relevant information on the working conditions applying to their situation. Unless Member States provide otherwise, those obligations apply if the duration of the work period abroad is longer than four consecutive weeks. (27) Probationary periods allow the parties to the employment relationship to verify that the workers and the positions for which they were engaged are compatible while providing workers with accompanying support. An entry into the labour market or a transition to a new position should not be subject to prolonged insecurity. As established in the European Pillar of Social Rights, probationary periods should therefore be of a reasonable duration. (28) A substantial number of Member States have established a general maximum duration of probation of between three and six months, which should be considered to be reasonable. Exceptionally, it should be possible for probationary periods to last longer than six months, where justified by the nature of the employment, such as for managerial or executive positions or public service posts, or where in the interests of the worker, such as in the context of specific measures promoting permanent employment, in particular for young workers. It should also be possible for probationary periods to be extended correspondingly in cases where the worker has been absent from work during the probationary period, for instance because of sickness or leave, to enable the employer to assess the suitability of the worker for the task in question. In the case of fixed-term employment relationships of less than 12 months, Member States should ensure that the length of the probationary period is adequate and proportionate to the expected duration of the contract and the nature of the work. Where provided for in national law or practice, workers should be able to accrue employment rights during the probationary period. (29) An employer should neither prohibit a worker from taking up employment with other employers, outside the work schedule established with that employer, nor subject a worker to adverse treatment for doing so. It should be possible for Member States to lay down conditions for the use of incompatibility restrictions, which are to be understood as restrictions on working for other employers for objective reasons, such as for the protection of the health and safety of workers including by limiting working time, the protection of business confidentiality, the integrity of the public service or the avoidance of conflicts of interests. (30) Workers whose work pattern is entirely or mostly unpredictable should benefit from a minimum level of predictability where the work schedule is determined mainly by the employer, be it directly, such as by allocating work assignments, or indirectly, such as by requiring the worker to respond to clients\u2019 requests. (31) Reference hours and days, which are to be understood as time slots during which work can take place at the request of the employer, should be established in writing at the start of the employment relationship. (32) A reasonable minimum notice period, which is to be understood as the period of time between the moment when a worker is informed of a new work assignment and the moment when the assignment starts, constitutes another necessary element of predictability of work for employment relationships with work patterns which are entirely or mostly unpredictable. The length of the notice period may vary according to the needs of the sector concerned, while ensuring the adequate protection of workers. The minimum notice period applies without prejudice to Directive 2002/15/EC of the European Parliament and of the Council (12). (33) Workers should have the possibility to refuse a work assignment if it falls outside of the reference hours and days or if they were not notified of the work assignment in accordance with the minimum notice period, without suffering adverse consequences for this refusal. Workers should also have the possibility to accept the work assignment if they so wish. (34) Where a worker whose work pattern is entirely or mostly unpredictable has agreed with his or her employer to undertake a specific work assignment, the worker should be able to plan accordingly. The worker should be protected against loss of income resulting from the late cancellation of an agreed work assignment by means of adequate compensation. (35) On-demand or similar employment contracts, including zero-hour contracts, under which the employer has the flexibility of calling the worker to work as and when needed, are particularly unpredictable for the worker. Member States that allow such contracts should ensure that effective measures to prevent their abuse are in place. Such measures could take the form of limitations to the use and duration of such contracts, of a rebuttable presumption of the existence of an employment contract or employment relationship with a guaranteed amount of paid hours based on hours worked in a preceding reference period, or of other equivalent measures that ensure the effective prevention of abusive practices. (36) Where employers have the possibility to offer full-time or open-ended employment contracts to workers in non-standard forms of employment, a transition to more secure forms of employment should be promoted in accordance with the principles established in the European Pillar of Social Rights. Workers should be able to request another more predictable and secure form of employment, where available, and receive a reasoned written response from the employer, which takes into account the needs of the employer and of the worker. Member States should have the possibility to limit the frequency of such requests. This Directive should not prevent Member States from establishing that, in the case of public service positions for which entry is by competitive examination, those positions are not to be considered to be available on the simple request of the worker, and so fall outside the scope of the right to request a form of employment with more predictable and secure working conditions. (37) Where employers are required by Union or national law or collective agreements to provide training to workers to carry out the work for which they are employed, it is important to ensure that such training is provided equally to all workers, including to those in non-standard forms of employment. The costs of such training should not be charged to the worker or withheld or deducted from the worker\u2019s remuneration. Such training should count as working time and, where possible, should be carried out during working hours. That obligation does not cover vocational training or training required for workers to obtain, maintain or renew a professional qualification as long as the employer is not required by Union or national law or collective agreement to provide it to the worker. Member States should take the necessary measures to protect workers from abusive practices regarding training. (38) The autonomy of the social partners and their capacity as representatives of workers and employers should be respected. It should therefore be possible for the social partners to consider that in specific sectors or situations different provisions are more appropriate, for the pursuit of the purpose of this Directive, than certain minimum standards set out in this Directive. Member States should therefore be able to allow the social partners to maintain, negotiate, conclude and enforce collective agreements which differ from certain provisions contained in this Directive, provided that the overall level of protection of workers is not lowered. (39) The public consultation on the European Pillar of Social Rights showed the need to strengthen enforcement of Union labour law to ensure its effectiveness. The evaluation of Directive 91/533/EEC conducted under the Commission\u2019s Regulatory Fitness and Performance Programme confirmed that strengthened enforcement mechanisms could improve the effectiveness of Union labour law. The consultation showed that redress systems based solely on claims for damages are less effective than systems that also provide for penalties, such as lump sums or loss of permits, for employers who fail to issue written statements. It also showed that employees rarely seek redress during the employment relationship, which jeopardises the goal of the provision of the written statement, which is to ensure that workers are informed about the essential features of the employment relationship. It is therefore necessary to introduce enforcement provisions which ensure the use of favourable presumptions where information about the employment relationship is not provided, or of a procedure under which the employer may be required to provide the missing information and may be subject to a penalty if the employer does not do so, or both. It should be possible for such favourable presumptions to include a presumption that the worker has an open-ended employment relationship, that there is no probationary period or that the worker has a full-time position, where the relevant information is missing. Redress could be subject to a procedure by which the employer is notified by the worker or by a third party such as a worker\u2019s representative or other competent authority or body that information is missing and to supply complete and correct information in a timely manner. (40) An extensive system of enforcement provisions for the social acquis in the Union has been adopted since Directive 91/533/EEC, in particular in the fields of equal treatment, elements of which should be applied to this Directive in order to ensure that workers have access to effective and impartial dispute resolution, such as a civil or labour court and a right to redress, which may include adequate compensation, reflecting the Principle No 7 of the European Pillar of Social Rights. (41) Specifically, having regard to the fundamental nature of the right to effective legal protection, workers should continue to enjoy such protection even after the end of the employment relationship giving rise to an alleged breach of the worker\u2019s rights under this Directive. (42) The effective implementation of this Directive requires adequate judicial and administrative protection against any adverse treatment as a reaction to an attempt to exercise rights provided for under this Directive, any complaint to the employer or any legal or administrative proceedings aimed at enforcing compliance with this Directive. (43) Workers exercising rights provided for in this Directive should enjoy protection from dismissal or equivalent detriment, such as an on-demand worker no longer being assigned work, or any preparations for a possible dismissal, on the grounds that they sought to exercise such rights. Where workers consider that they have been dismissed or have suffered equivalent detriment on those grounds, workers and competent authorities or bodies should be able to require the employer to provide duly substantiated grounds for the dismissal or equivalent measure. (44) The burden of proof with regard to establishing that there has been no dismissal or equivalent detriment on the grounds that workers have exercised their rights provided for in this Directive, should fall on employers when workers establish, before a court or other competent authority or body, facts from which it may be presumed that they have been dismissed, or have been subject to measures with equivalent effect, on such grounds. It should be possible for Member States not to apply that rule in proceedings, in which it would be for a court or other competent authority or body to investigate the facts, in particular in systems where dismissal has to be approved beforehand by such authority or body. (45) Member States should provide for effective, proportionate and dissuasive penalties for breaches of the obligations under this Directive. Penalties can include administrative and financial penalties, such as fines or the payment of compensation, as well as other types of penalties. (46) Since the objective of this Directive, namely to improve working conditions by promoting more transparent and predictable employment while ensuring labour market adaptability, cannot be sufficiently achieved by the Member States but can rather, by reason of the need to establish common minimum requirements, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (47) This Directive lays down minimum requirements, thus leaving untouched Member States\u2019 prerogative to introduce and maintain more favourable provisions. Rights acquired under the existing legal framework should continue to apply, unless more favourable provisions are introduced by this Directive. The implementation of this Directive cannot be used to reduce existing rights set out in existing Union or national law in this field, nor can it constitute valid grounds for reducing the general level of protection afforded to workers in the field covered by this Directive. In particular, it should not serve as grounds for the introduction of zero-hour contracts or similar types of employment contracts. (48) In implementing this Directive Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of micro, small and medium-sized enterprises. Member States are therefore invited to assess the impact of their transposition act on small and medium-sized enterprises in order to ensure that they are not disproportionately affected, giving specific attention to micro-enterprises and to the administrative burden, and to publish the results of such assessments. (49) The Member States may entrust the social partners with the implementation of this Directive, where the social partners jointly request to do so and provided that the Member States take all the necessary steps to ensure that they can at all times guarantee the results sought under this Directive. They should also, in accordance with national law and practice, take adequate measures to ensure the effective involvement of the social partners and to promote and enhance social dialogue with a view to implementing the provisions of this Directive. (50) Member States should take any adequate measure to ensure fulfilment of the obligations arising from this Directive, for example by carrying out inspections, as appropriate. (51) In view of the substantial changes introduced by this Directive with regard to the purpose, scope and content of Directive 91/533/EEC, it is not appropriate to amend that directive. Directive 91/533/EEC should therefore be repealed. (52) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (13), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I GENERAL PROVISIONS Article 1 Purpose, subject matter and scope 1. The purpose of this Directive is to improve working conditions by promoting more transparent and predictable employment while ensuring labour market adaptability. 2. This Directive lays down minimum rights that apply to every worker in the Union who has an employment contract or employment relationship as defined by the law, collective agreements or practice in force in each Member State with consideration to the case-law of the Court of Justice. 3. Member States may decide not to apply the obligations in this Directive to workers who have an employment relationship in which their predetermined and actual working time is equal to or less than an average of three hours per week in a reference period of four consecutive weeks. Time worked with all employers forming or belonging to the same enterprise, group or entity shall count towards that three-hour average. 4. Paragraph 3 shall not apply to an employment relationship where no guaranteed amount of paid work is predetermined before the employment starts. 5. Member States may determine which persons are responsible for the execution of the obligations for employers laid down by this Directive as long as all those obligations are fulfilled. They may also decide that all or part of those obligations are to be assigned to a natural or legal person who is not party to the employment relationship. This paragraph is without prejudice to Directive 2008/104/EC of the European Parliament and of the Council (14). 6. Member States may provide, on objective grounds, that the provisions laid down in Chapter III are not to apply to civil servants, public emergency services, the armed forces, police authorities, judges, prosecutors, investigators or other law enforcement services. 7. Member States may decide not to apply the obligations set out in Articles 12 and 13 and in point (a) of Article 15(1) to natural persons in households acting as employers where work is performed for those households. 8. Chapter II of this Directive applies to seafarers and sea fishermen without prejudice to Directives 2009/13/EC and Directive (EU) 2017/159, respectively. The obligations set out in points (m) and (o) of Article 4(2), and Articles 7, 9, 10 and 12 shall not apply to seafarers or sea fishermen. Article 2 Definitions For the purposes of this Directive, the following definitions apply: (a) \u2018work schedule\u2019 means the schedule determining the hours and days on which performance of work starts and ends; (b) \u2018reference hours and days\u2019 means time slots in specified days during which work can take place at the request of the employer; (c) \u2018work pattern\u2019 means the form of organisation of the working time and its distribution according to a certain pattern determined by the employer. Article 3 Provision of information The employer shall provide each worker with the information required pursuant to this Directive in writing. The information shall be provided and transmitted on paper or, provided that the information is accessible to the worker, that it can be stored and printed, and that the employer retains proof of transmission or receipt, in electronic form. CHAPTER II INFORMATION ABOUT THE EMPLOYMENT RELATIONSHIP Article 4 Obligation to provide information 1. Member States shall ensure that employers are required to inform workers of the essential aspects of the employment relationship. 2. The information referred to in paragraph 1 shall include at least the following: (a) the identities of the parties to the employment relationship; (b) the place of work; where there is no fixed or main place of work, the principle that the worker is employed at various places or is free to determine his or her place of work, and the registered place of business or, where appropriate, the domicile of the employer; (c) either: (i) the title, grade, nature or category of work for which the worker is employed or (ii) a brief specification or description of the work; (d) the date of commencement of the employment relationship; (e) in the case of a fixed-term employment relationship, the end date or the expected duration thereof; (f) in the case of temporary agency workers, the identity of the user undertakings, when and as soon as known; (g) the duration and conditions of the probationary period, if any; (h) the training entitlement provided by the employer, if any; (i) the amount of paid leave to which the worker is entitled or, where this cannot be indicated when the information is given, the procedures for allocating and determining such leave; (j) the procedure to be observed by the employer and the worker, including the formal requirements and the notice periods, where their employment relationship is terminated or, where the length of the notice periods cannot be indicated when the information is given, the method for determining such notice periods; (k) the remuneration, including the initial basic amount, any other component elements, if applicable, indicated separately, and the frequency and method of payment of the remuneration to which the worker is entitled; (l) if the work pattern is entirely or mostly predictable, the length of the worker\u2019s standard working day or week and any arrangements for overtime and its remuneration and, where applicable, any arrangements for shift changes; (m) if the work pattern is entirely or mostly unpredictable, the employer shall inform the worker of: (i) the principle that the work schedule is variable, the number of guaranteed paid hours and the remuneration for work performed in addition to those guaranteed hours; (ii) the reference hours and days within which the worker may be required to work; (iii) the minimum notice period to which the worker is entitled before the start of a work assignment and, where applicable, the deadline for cancellation referred to in Article 10(3); (n) any collective agreements governing the worker\u2019s conditions of work or in the case of collective agreements concluded outside the business by special joint bodies or institutions, the name of such bodies or institutions within which the agreements were concluded; (o) where it is the responsibility of the employer, the identity of the social security institutions receiving the social contributions attached to the employment relationship and any protection relating to social security provided by the employer. 3. The information referred to in paragraph 2(g) to (l) and (o) may, where appropriate, be given in the form of a reference to the laws, regulations and administrative or statutory provisions or collective agreements governing those points. Article 5 Timing and means of information 1. Where not previously provided, the information referred to in points (a) to (e), (g), (k), (l) and (m) of Article 4(2) shall be provided individually to the worker in the form of one or more documents during a period starting on the first working day and ending no later than the seventh calendar day. The other information referred to in Article 4(2) shall be provided individually to the worker in the form of a document within one month of the first working day. 2. Member States may develop templates and models for the documents referred to in paragraph 1 and put them at the disposal of worker and employer including by making them available on a single official national website or by other suitable means. 3. Member States shall ensure that the information on the laws, regulations and administrative or statutory provisions or universally applicable collective agreements governing the legal framework applicable which are to be communicated by employers is made generally available free of charge in a clear, transparent, comprehensive and easily accessible way at a distance and by electronic means, including through existing online portals. Article 6 Modification of the employment relationship 1. Member States shall ensure that any change in the aspects of the employment relationship referred to in Article 4(2) and any change to the additional information for workers sent to another Member State or to a third country referred to in Article 7 shall be provided in the form of a document by the employer to the worker at the earliest opportunity and at the latest on the day on which it takes effect. 2. The document referred to in paragraph 1 shall not apply to changes that merely reflect a change in the laws, regulations and administrative or statutory provisions or collective agreements cited in the documents referred to in Article 5(1), and, where relevant, in Article 7. Article 7 Additional information for workers sent to another Member State or to a third country 1. Member States shall ensure that, where a worker is required to work in a Member State or third country other than the Member State in which he or she habitually works, the employer shall provide the documents referred to in Article 5(1) before the worker\u2019s departure and the documents shall include at least the following additional information: (a) the country or countries in which the work abroad is to be performed and its anticipated duration; (b) the currency to be used for the payment of remuneration; (c) where applicable, the benefits in cash or kind relating to the work assignments; (d) information as to whether repatriation is provided for, and if so, the conditions governing the worker\u2019s repatriation. 2. Member States shall ensure that a posted worker covered by Directive 96/71/EC shall in addition be notified of: (a) the remuneration to which the worker is entitled in accordance with the applicable law of the host Member State; (b) where applicable, any allowances specific to posting and any arrangements for reimbursing expenditure on travel, board and lodging; (c) the link to the single official national website developed by the host Member State pursuant to Article 5(2) of Directive 2014/67/EU of the European Parliament and of the Council (15). 3. The information referred to in point (b) of paragraph 1 and point (a) of paragraph 2 may, where appropriate, be given in the form of a reference to specific provisions of laws, regulations and administrative or statutory acts or collective agreements governing that information. 4. Unless Member States provide otherwise, paragraphs 1 and 2 shall not apply if the duration of each work period outside the Member State in which the worker habitually works is four consecutive weeks or less. CHAPTER III MINIMUM REQUIREMENTS RELATING TO WORKING CONDITIONS Article 8 Maximum duration of any probationary period 1. Member States shall ensure that, where an employment relationship is subject to a probationary period as defined in national law or practice, that period shall not exceed six months. 2. In the case of fixed-term employment relationships, Member States shall ensure that the length of such a probationary period is proportionate to the expected duration of the contract and the nature of the work. In the case of the renewal of a contract for the same function and tasks, the employment relationship shall not be subject to a new probationary period. 3. Member States may, on an exceptional basis, provide for longer probationary periods where justified by the nature of the employment or in the interest of the worker. Where the worker has been absent from work during the probationary period, Member States may provide that the probationary period can be extended correspondingly, in relation to the duration of the absence. Article 9 Parallel employment 1. Member States shall ensure that an employer neither prohibits a worker from taking up employment with other employers, outside the work schedule established with that employer, nor subjects a worker to adverse treatment for doing so. 2. Member States may lay down conditions for the use of incompatibility restrictions by employers, on the basis of objective grounds, such as health and safety, the protection of business confidentiality, the integrity of the public service or the avoidance of conflicts of interests. Article 10 Minimum predictability of work 1. Member States shall ensure that where a worker\u2019s work pattern is entirely or mostly unpredictable the worker shall not be required to work by the employer unless both of the following conditions are fulfilled: (a) the work takes place within predetermined reference hours and days as referred to in point (m)(ii) of Article 4(2); and (b) the worker is informed by his or her employer of a work assignment within a reasonable notice period established in accordance with national law, collective agreements or practice as referred to in point (m)(iii) of Article 4(2). 2. Where one or both of the requirements laid down in paragraph 1 is not fulfilled, a worker shall have the right to refuse a work assignment without adverse consequences. 3. Where Member States allow an employer to cancel a work assignment without compensation, Member States shall take the measures necessary, in accordance with national law, collective agreements or practice, to ensure that the worker is entitled to compensation if the employer cancels, after a specified reasonable deadline, the work assignment previously agreed with the worker. 4. Member States may lay down modalities for the application of this Article, in accordance with national law, collective agreements or practice. Article 11 Complementary measures for on-demand contracts Where Member States allow for the use of on-demand or similar employment contracts, they shall take one or more of the following measures to prevent abusive practices: (a) limitations to the use and duration of on-demand or similar employment contracts; (b) a rebuttable presumption of the existence of an employment contract with a minimum amount of paid hours based on the average hours worked during a given period; (c) other equivalent measures that ensure effective prevention of abusive practices. Member States shall inform the Commission of such measures. Article 12 Transition to another form of employment 1. Member States shall ensure that a worker with at least six months\u2019 service with the same employer, who has completed his or her probationary period, if any, may request a form of employment with more predictable and secure working conditions where available and receive a reasoned written reply. Member States may limit the frequency of requests triggering the obligation under this Article. 2. Member States shall ensure that the employer provides the reasoned written reply referred to in paragraph 1 within one month of the request. With respect to natural persons acting as employers and micro, small, or medium enterprises, Member States may provide for that deadline to be extended to no more than three months and allow for an oral reply to a subsequent similar request submitted by the same worker if the justification for the reply as regards the situation of the worker remains unchanged. Article 13 Mandatory training Member States shall ensure that where an employer is required by Union or national law or by collective agreements to provide training to a worker to carry out the work for which he or she is employed, such training shall be provided to the worker free of cost, shall count as working time and, where possible, shall take place during working hours. Article 14 Collective agreements Member States may allow the social partners to maintain, negotiate, conclude and enforce collective agreements, in conformity with the national law or practice, which, while respecting the overall protection of workers, establish arrangements concerning the working conditions of workers which differ from those referred to in Articles 8 to 13. CHAPTER IV HORIZONTAL PROVISIONS Article 15 Legal presumptions and early settlement mechanism 1. Member States shall ensure that, where a worker has not received in due time all or part of the documents referred to in Article 5(1) or Article 6, one or both of the following shall apply: (a) the worker shall benefit from favourable presumptions defined by the Member State, which employers shall have the possibility to rebut; (b) the worker shall have the possibility to submit a complaint to a competent authority or body and to receive adequate redress in a timely and effective manner. 2. Member States may provide that the application of the presumptions and mechanism referred to in paragraph 1 is subject to the notification of the employer and the failure of the employer to provide the missing information in a timely manner. Article 16 Right to redress Member States shall ensure that workers, including those whose employment relationship has ended, have access to effective and impartial dispute resolution and a right to redress in the case of infringements of their rights arising from this Directive. Article 17 Protection against adverse treatment or consequences Member States shall introduce the measures necessary to protect workers, including those who are workers\u2019 representatives, from any adverse treatment by the employer and from any adverse consequences resulting from a complaint lodged with the employer or resulting from any proceedings initiated with the aim of enforcing compliance with the rights provided for in this Directive. Article 18 Protection from dismissal and burden of proof 1. Member States shall take the necessary measures to prohibit the dismissal or its equivalent and all preparations for dismissal of workers, on the grounds that they have exercised the rights provided for in this Directive. 2. Workers who consider that they have been dismissed, or have been subject to measures with equivalent effect, on the grounds that they have exercised the rights provided for in this Directive, may request the employer to provide duly substantiated grounds for the dismissal or the equivalent measures. The employer shall provide those grounds in writing. 3. Member States shall take the necessary measures to ensure that, when workers referred to in paragraph 2 establish, before a court or other competent authority or body, facts from which it may be presumed that there has been such a dismissal or equivalent measures, it shall be for the employer to prove that the dismissal was based on grounds other than those referred to in paragraph 1. 4. Paragraph 3 shall not prevent Member States from introducing rules of evidence which are more favourable to workers. 5. Member States shall not be required to apply paragraph 3 to proceedings in which it is for the court or other competent authority or body to investigate the facts of the case. 6. Paragraph 3 shall not apply to criminal proceedings, unless otherwise provided by the Member State. Article 19 Penalties Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive or the relevant provisions already in force concerning the rights which are within the scope of this Directive. The penalties provided for shall be effective, proportionate and dissuasive. CHAPTER V FINAL PROVISIONS Article 20 Non-regression and more favourable provisions 1. This Directive shall not constitute valid grounds for reducing the general level of protection already afforded to workers within Member States. 2. This Directive shall not affect Member States\u2019 prerogative to apply or to introduce laws, regulations or administrative provisions which are more favourable to workers or to encourage or permit the application of collective agreements which are more favourable to workers. 3. This Directive is without prejudice to any other rights conferred on workers by other legal acts of the Union. Article 21 Transposition and implementation 1. Member States shall take the necessary measures to comply with this Directive by 1 August 2022. They shall immediately inform the Commission thereof. 2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 3. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive. 4. Member States shall, in accordance with their national law and practice, take adequate measures to ensure the effective involvement of the social partners and to promote and enhance social dialogue with a view to implementing this Directive. 5. Member States may entrust the social partners with the implementation of this Directive, where the social partners jointly request to do so and provided that Member States take all necessary steps to ensure that they can at all times guarantee the results sought under this Directive. Article 22 Transitional arrangements The rights and obligations set out in this Directive shall apply to all employment relationships by 1 August 2022. However, an employer shall provide or complement the documents referred to in Article 5(1) and in Articles 6 and 7 only upon the request of a worker who is already employed on that date. The absence of such a request shall not have the effect of excluding a worker from the minimum rights established in Articles 8 to 13. Article 23 Review by the Commission By 1 August 2027, the Commission shall, after consulting the Member States and the social partners at Union level and taking into account the impact on micro, small and medium-sized enterprises, review the implementation of this Directive and propose, where appropriate, legislative amendments. Article 24 Repeal Directive 91/533/EEC shall be repealed with effect from 1 August 2022. References to the repealed Directive shall be construed as references to this Directive. Article 25 Entry into force This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 26 Addressees This Directive is addressed to the Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 283, 10.8.2018, p. 39. (2) OJ C 387, 25.10.2018, p. 53. (3) Position of the European Parliament of 16 April 2019 (not yet published in the Official Journal) and decision of the Council of 13 June 2019. (4) Council Directive 91/533/EEC of 14 October 1991 on an employer\u2019s obligation to inform employees of the conditions applicable to the contract or employment relationship (OJ L 288, 18.10.1991, p. 32). (5) Judgments of the Court of Justice of 3 July 1986, Deborah Lawrie-Blum v Land Baden-W\u00fcrttemberg, C-66/85, ECLI:EU:C:1986:284; 14 October 2010, Union Syndicale Solidaires Is\u00e8re v Premier ministre and Others, C-428/09, ECLI:EU:C:2010:612; 9 July 2015, Ender Balkaya v Kiesel Abbruch- und Recycling Technik GmbH, C-229/14, ECLI:EU:C:2015:455; 4 December 2014, FNV Kunsten Informatie en Media v Staat der Nederlanden, C-413/13, ECLI:EU:C:2014:2411; and 17 November 2016, Betriebsrat der Ruhrlandklinik gGmbH v Ruhrlandklinik gGmbH, C-216/15, ECLI:EU:C:2016:883. (6) Council Directive 2009/13/EC of 16 February 2009 implementing the Agreement concluded by the European Community Shipowners\u2019 Associations (ECSA) and the European Transport Workers\u2019 Federation (ETF) on the Maritime Labour Convention, 2006, and amending Directive 1999/63/EC (OJ L 124, 20.5.2009, p. 30). (7) Council Directive (EU) 2017/159 of 19 December 2016 implementing the Agreement concerning the implementation of the Work in Fishing Convention, 2007 of the International Labour Organisation, concluded on 21 May 2012 between the General Confederation of Agricultural Cooperatives in the European Union (Cogeca), the European Transport Workers\u2019 Federation (ETF) and the Association of National Organisations of Fishing Enterprises in the European Union (Europ\u00eache) (OJ L 25, 31.1.2017, p. 12). (8) Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time (OJ L 299, 18.11.2003, p. 9). (9) Directive 2014/50/EU of the European Parliament and of the Council of 16 April 2014 on minimum requirements for enhancing worker mobility between Member States by improving the acquisition and preservation of supplementary pension rights (OJ L 128, 30.4.2014, p. 1). (10) Council Directive 98/49/EC of 29 June 1998 on safeguarding the supplementary pension rights of employed and self-employed persons moving within the Community (OJ L 209, 25.7.1998, p. 46). (11) Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (OJ L 18, 21.1.1997, p. 1). (12) Directive 2002/15/EC of the European Parliament and of the Council of 11 March 2002 on the organisation of the working time of persons performing mobile road transport activities (OJ L 80, 23.3.2002, p. 35). (13) OJ C 369, 17.12.2011, p. 14. (14) Directive 2008/104/EC of the European Parliament and of the Council of 19 November 2008 on temporary agency work (OJ L 327, 5.12.2008, p. 9). (15) Directive 2014/67/EU of the European Parliament and of the Council of 15 May 2014 on the enforcement of Directive 96/71/EC concerning the posting of workers in the framework of the provision of services and amending Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System (\u2018the IMI Regulation\u2019) (OJ L 159, 28.5.2014, p. 11).", "summary": "Transparent and predictable working conditions in the EU Transparent and predictable working conditions in the EU SUMMARY OF: Directive (EU) 2019/1152 on transparent and predictable working conditions in the European Union WHAT IS THE AIM OF THE DIRECTIVE? It aims to improve working conditions by promoting more transparent and predictable employment while ensuring labour-market adaptability. It introduces minimum rights and updates the rules on the information to be provided to workers concerning their working conditions. The directive contributes to reinforcing Europe\u2019s social dimension as part of the European Pillar of Social Rights roll-out. KEY POINTS The directive is issued in the context of Article 31 of the Charter of Fundamental Rights of the EU which says that every worker has the right to working conditions which respect the worker\u2019s health, safety and dignity, which limit the maximum number of working hours, to daily and weekly rest periods and to an annual period of paid leave. It is also a concrete follow-up of Principles 5 and 7 of the European Pillar of Social Rights. Who is covered? The directive applies to those who work more than 3 hours per week over a 4-week period (i.e. more than 12 hours per month) who are bound by an employment contract or in an employment relationship as defined by national law, collective agreements or practice in force in each EU country \u2014 with consideration to the case-law of the Court of Justice of the EU. Persons covered could include workers on zero-hour contracts, such as fast-food-chain workers, workers in logistical centres, shelf-stackers in supermarkets, domestic or voucher-based workers* and platform-economy workers, such as on-demand drivers or couriers, provided they fulfil the above criteria defining a worker. Civil servants, the armed forces or members of emergency and law enforcement services may, on objective grounds, be excluded from Chapter III of the directive (Minimum requirements relating to working conditions). Employment relationship Employers must inform workers in writing, and at the latest within a week from the first working day, of the basic elements of the employment relationship, including: the identity of the parties to the employment relationship, the place of work and the nature of the activity; the start date and, if it is fixed-term, end date, as well as the duration and conditions of any probationary period; basic pay, any other component of remuneration, including overtime, and the frequency and method of payment; the duration of the normal workday or week when the work rhythm is predictable; where the pattern of work is unpredictable, employers must inform workers of the reference hours and days on which they may be called upon to work, the minimum notice before starting work and the number of guaranteed paid hours. For supplementary information as indicated just below, the deadline for employers to inform workers is at the latest 1 month from the first working day: the duration of paid leave; any training entitlement; any collective agreements governing the worker\u2019s conditions; the identity of the social security body receiving social contributions, where this is the employer\u2019s responsibility; notice periods where the employment relationship is terminated or the method for determining such notice periods; for temporary agency workers, the details of the user-undertakings (i.e. those making use of the agency workers\u2019 services) when and as soon as known. Workers relocated (\u2018posted\u2019) to another EU country or to a non-EU country Employers must provide relevant documents before departure including at least the following additional information: countries where the work is to be carried out and its expected duration; currency of payment; where applicable, benefits in cash or kind relating to the work assignments; information on whether repatriation is provided for, and the applicable conditions. Posted workers covered by Directive 96/71/EC (see summary here) must in addition be notified of, among other things: the applicable remuneration under the law of the host EU country; where applicable, any allowances specific to posting and any arrangements for reimbursing expenditure on travel and accommodation costs. Minimum requirements for the employment contract The directive sets a number of minimum rights for workers, including the right to: not have the probationary period exceed 6 months, unless it is in the worker\u2019s interest or when the activity justifies it; work for another employer outside the established working hours without unfavourable treatment, unless incompatibility restrictions are justified on objective grounds; for workers whose work pattern is decided by the employer and is entirely or mostly unpredictable, the right to refuse a work assignment outside previously defined reference hours and days without suffering adverse consequences; request, after six months\u2019 service with the same employer, a job with more predictable and secure working conditions; receive training cost free, when the employer is required by EU or national legislation or collective agreements to provide such training. EU countries may allow the social partners to conclude collective agreements which establish working conditions that differ from those referred to just above, provided that the overall protection of workers is respected. On-demand contracts * EU countries which allow the use of on-demand contracts or similar employment contracts (e.g. gig-economy or zero-hour contracts) must take measures to avoid abusive practices, such as: limiting the use and duration of on-demand employment or similar contracts; putting in place a rebuttable presumption* that an employment relationship exists, with a guaranteed number of paid hours based on hours worked in a preceding reference period. Complaints, redress, protections and dismissals EU countries must: ensure that workers who have not received the relevant information in due time have access to at least one of the following two measures: submit a complaint to a competent authority and receive redress in a timely and effective manner; orbenefit from favourable legal presumptions ensure that workers, including those whose employment relationship has ended, have access to effective and impartial dispute resolution and a right to redress*; introduce measures to protect workers from any adverse treatment by the employer and from any adverse consequences resulting from a complaint lodged with the employer; take measures to prohibit workers being dismissed because they have exercised the rights outlined in the directive. The directive does not constitute justification for reducing the general level of protection already enjoyed by workers in the EU, and does not prevent EU countries from adopting legislation that is more favourable to workers. Repeal The directive repeals Council Directive 91/533/EEC on Informing employees of their working conditions from 1 August 2022. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 31 July 2019 and has to become law in the EU countries by 1 August 2022. BACKGROUND See also: Transparent and predictable working conditions (European Commission) Factsheet: Towards transparent and predictable working conditions (European Commission). KEY TERMS Voucher-based worker: an employer acquires a voucher from a third party (generally a government authority) to be used, instead of cash, as payment to a worker providing a service. On-demand contract: a type of contract between an employer and a worker, such as a zero-hour contract, where the employer is not obliged to provide any minimum working hours, while the worker may or may not be obliged to accept any work offered. Rebuttable presumption: a presumption that a court holds to be true, unless someone comes forward to contest it and prove otherwise (\u2018presumed innocent until proven guilty\u2019 is a well-known rebuttable presumption). Right to redress: the right to ask for compensation. MAIN DOCUMENT Directive (EU) 2019/1152 of the European Parliament and of the Council of 20 June 2019 on transparent and predictable working conditions in the European Union (OJ L 186, 11.7.2019, pp. 105-121) RELATED DOCUMENTS Council Directive (EU) 2017/159 of 19 December 2016 implementing the Agreement concerning the implementation of the Work in Fishing Convention, 2007 of the International Labour Organisation, concluded on 21 May 2012 between the General Confederation of Agricultural Cooperatives in the European Union (Cogeca), the European Transport Workers' Federation (ETF) and the Association of National Organisations of Fishing Enterprises in the European Union (Europ\u00eache) (OJ L 25, 31.1.2017, pp. 12-35) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 Establishing a European Pillar of Social Rights (COM(2017) 250 final, 26.4.2017) Charter of Fundamental Rights of the European Union \u2014 Title IV \u2014 Solidarity \u2014 Article 31 \u2014 Fair and just working conditions (OJ C 202, 7.6.2016, p. 399) Directive 2014/50/EU of the European Parliament and of the Council of 16 April 2014 on minimum requirements for enhancing worker mobility between Member States by improving the acquisition and preservation of supplementary pension rights (OJ L 128, 30.4.2014, pp. 1-7) Council Directive 2009/13/EC of 16 February 2009 implementing the Agreement concluded by the European Community Shipowners\u2019 Associations (ECSA) and the European Transport Workers\u2019 Federation (ETF) on the Maritime Labour Convention, 2006, and amending Directive 1999/63/EC (OJ L 124, 20.5.2009, pp. 30-50) Successive amendments to Directive 2009/13/EC have been incorporated into the original text. This consolidated version is of documentary value only. Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time (OJ L 299, 18.11.2003, pp. 9-19) Council Directive 98/49/EC of 29 June 1998 on safeguarding the supplementary pension rights of employed and self-employed persons moving within the Community (OJ L 209, 25.7.1998, pp. 46-49) Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (OJ L 18, 21.1.1997, pp. 1-6) Council Directive 91/533/EEC of 14 October 1991 on an employer\u2019s obligation to inform employees of the conditions applicable to the contract or employment relationship (OJ L 288, 18.10.1991, pp. 32-35) last update 25.10.2019"}
{"article": "28.7.2017 EN Official Journal of the European Union L 198/29 DIRECTIVE (EU) 2017/1371 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 83(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the Committee of the Regions (1) Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The protection of the Union's financial interests concerns not only the management of budget appropriations, but extends to all measures which negatively affect or which threaten to negatively affect its assets and those of the Member States, to the extent that those measures are of relevance to Union policies. (2) The Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities' financial interests of 26 July 1995 (3), including the Protocols thereto of 27 September 1996 (4), of 29 November 1996 (5) and of 19 June 1997 (6) (the \u2018Convention\u2019) establishes minimum rules relating to the definition of criminal offences and sanctions in the area of fraud affecting the Union's financial interests. The Member States drew up the Convention, in which it was noted that fraud affecting Union revenue and expenditure in many cases was not confined to a single country and was often committed by organised criminal networks. On that basis, it was already recognised in the Convention that the protection of the Union's financial interests called for the criminal prosecution of fraudulent conduct injuring those interests. In parallel, Council Regulation (EC, Euratom) No 2988/95 (7) was adopted. That Regulation lays down general rules relating to homogenous checks and to administrative measures and penalties concerning irregularities with regard to Union law while, at the same time, referring to sectoral rules in that area, fraudulent actions as defined in the Convention and the application of the Member States' criminal law and proceedings. (3) Union policy in the area of the protection of the Union's financial interests has already been the subject of harmonisation measures such as Regulation (EC, Euratom) No 2988/95. In order to ensure the implementation of Union policy in this area, it is essential to continue to approximate the criminal law of the Member States by complementing the protection of the Union's financial interests under administrative and civil law for the most serious types of fraud-related conduct in that field, whilst avoiding inconsistencies, both within and among those areas of law. (4) The protection of the Union's financial interests calls for a common definition of fraud falling within the scope of this Directive, which should cover fraudulent conduct with respect to revenues, expenditure and assets at the expense of the general budget of the European Union (the \u2018Union budget\u2019), including financial operations such as borrowing and lending activities. The notion of serious offences against the common system of value added tax (\u2018VAT\u2019) as established by Council Directive 2006/112/EC (8) (the \u2018common VAT system\u2019) refers to the most serious forms of VAT fraud, in particular carrousel fraud, VAT fraud through missing traders, and VAT fraud committed within a criminal organisation, which create serious threats to the common VAT system and thus to the Union budget. Offences against the common VAT system should be considered to be serious where they are connected with the territory of two or more Member States, result from a fraudulent scheme whereby those offences are committed in a structured way with the aim of taking undue advantage of the common VAT system and the total damage caused by the offences is at least EUR 10 000 000. The notion of total damage refers to the estimated damage that results from the entire fraud scheme, both to the financial interests of the Member States concerned and to the Union, excluding interest and penalties. This Directive aims to contribute to the efforts to fight those criminal phenomena. (5) When the Commission implements the Union budget under shared or indirect management, it may delegate budget implementation tasks to the Member States or entrust them to bodies, offices or agencies established pursuant to the Treaties or to other entities or persons. In the event of such shared or indirect management, the Union's financial interests should benefit from the same level of protection as they do when under the direct management of the Commission. (6) For the purposes of this Directive, procurement-related expenditure is any expenditure in connection with the public contracts determined by Article 101(1) of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (9). (7) Union money laundering law is fully applicable to money laundering involving property derived from the criminal offences covered by this Directive. A reference made to that law should ensure that the sanctioning regime introduced by this Directive applies to all serious cases of criminal offences against the Union's financial interests. (8) Corruption constitutes a particularly serious threat to the Union's financial interests, which can in many cases also be linked to fraudulent conduct. Since all public officials have a duty to exercise judgment or discretion impartially, the giving of bribes in order to influence a public official's judgment or discretion and the taking of such bribes should be included in the definition of corruption, irrespective of the law or regulations applicable in the particular official's country or to the international organisation concerned. (9) The Union's financial interests can be negatively affected by certain types of conduct of a public official who is entrusted with the management of funds or assets, whether he or she is in charge or acts in a supervisory capacity, which types of conduct aim at misappropriating funds or assets, contrary to the intended purpose and whereby the Union's financial interests are damaged. There is therefore a need to introduce a precise definition of criminal offences covering such conduct. (10) As regards the criminal offences of passive corruption and misappropriation, there is a need to include a definition of public officials covering all relevant officials, whether holding a formal office in the Union, in the Member States or in third countries. Private persons are increasingly involved in the management of Union funds. In order to protect Union funds adequately from corruption and misappropriation, the definition of \u2018public official\u2019 therefore needs to cover persons who do not hold formal office but who are nonetheless assigned and exercise, in a similar manner, a public service function in relation to Union funds, such as contractors involved in the management of such funds. (11) With regard to the criminal offences provided for in this Directive, the notion of intention must apply to all the elements constituting those criminal offences. The intentional nature of an act or omission may be inferred from objective, factual circumstances. Criminal offences which do not require intention are not covered by this Directive. (12) This Directive does not oblige Member States to provide for sanctions of imprisonment for the commission of criminal offences that are not of a serious nature, in cases where intent is presumed under national law. (13) Some criminal offences against the Union's financial interests are in practice often closely related to the criminal offences covered by Article 83(1) of the Treaty on the Functioning of the European Union (TFEU) and Union legislative acts that are based on that provision. Coherence between such legislative acts and this Directive should therefore be ensured in the wording of this Directive. (14) Insofar as the Union's financial interests can be damaged or threatened by conduct attributable to legal persons, legal persons should be liable for the criminal offences, as defined in this Directive, which are committed on their behalf. (15) In order to ensure equivalent protection of the Union's financial interests throughout the Union by means of measures which should act as a deterrent, Member States should provide for certain types and levels of sanctions when the criminal offences defined in this Directive are committed. The levels of sanctions should not go beyond what is proportionate for the offences. (16) As this Directive provides for minimum rules, Member States are free to adopt or maintain more stringent rules for criminal offences affecting the Union's financial interests. (17) This Directive does not affect the proper and effective application of disciplinary measures or penalties other than of a criminal nature. Sanctions that cannot be equated to criminal sanctions, which are imposed on the same person for the same conduct, can be taken into account when sentencing that person for a criminal offence defined in this Directive. For other sanctions, the principle of prohibition of being tried or punished twice in criminal proceedings for the same criminal offence (ne bis in idem) should be fully respected. This Directive does not criminalise behaviour which is not also subject to disciplinary penalties or other measures concerning a breach of official duties, in cases where such disciplinary penalties or other measures can be applied to the persons concerned. (18) Sanctions with regard to natural persons should, in certain cases, provide for a maximum penalty of at least four years of imprisonment. Such cases should include at least those involving considerable damage done or advantage gained whereby the damage or advantage should be presumed to be considerable when it involves more than EUR 100 000. Where a Member State's law does not provide for an explicit threshold for considerable damage or advantage as a basis for a maximum penalty, the Member State should ensure that the amount of damage or advantage is taken into account by its courts in the determination of sanctions for fraud and other criminal offences affecting the Union's financial interests. This Directive does not prevent Member States from providing for other elements which would indicate the serious nature of a criminal offence, for instance when the damage or advantage is potential, but of very considerable nature. However, for offences against the common VAT system, the threshold as of which the damage or advantage should be presumed to be considerable is, in conformity with this Directive, EUR 10 000 000. The introduction of minimum levels of maximum imprisonment sanctions is necessary in order to ensure equivalent protection of the Union's financial interests throughout the Union. The sanctions are intended to serve as a strong deterrent for potential offenders, with effect throughout the Union. (19) Member States should ensure that the fact that a criminal offence is committed within a criminal organisation as defined in Council Framework Decision 2008/841/JHA (10) is considered to be an aggravating circumstance in accordance with the applicable rules established by their legal systems. They should ensure that the aggravating circumstance is made available to judges for their consideration when sentencing offenders, although there is no obligation on judges to take the aggravating circumstance into account in their sentence. Member States are not obliged to provide for the aggravating circumstance where national law provides for the criminal offences as defined in Framework Decision 2008/841/JHA to be punishable as a separate criminal offence and this may lead to more severe sanctions. (20) Given, in particular, the mobility of perpetrators and of the proceeds stemming from illegal activities at the expense of the Union's financial interests, as well as the complex cross-border investigations which this entails, each Member State should establish its jurisdiction in order to enable it to counter such activities. Each Member State should thereby ensure that its jurisdiction covers criminal offences which are committed using information and communication technology accessed from its territory. (21) Given the possibility of multiple jurisdictions for cross-border criminal offences falling under the scope of this Directive, the Member States should ensure that the principle of ne bis in idem is respected in full in the application of national law transposing this Directive. (22) Member States should lay down rules concerning limitation periods necessary in order to enable them to counter illegal activities at the expense of the Union's financial interests. In cases of criminal offences punishable by a maximum sanction of at least four years of imprisonment, the limitation period should be at least five years from the time when the criminal offence was committed. This should be without prejudice to those Member States which do not set limitation periods for investigation, prosecution and enforcement. (23) Without prejudice to the rules on cross-border cooperation and mutual legal assistance in criminal matters and to other rules under Union law, in particular under Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (11), there is a need for appropriate provision to be made for cooperation to ensure effective action against the criminal offences defined in this Directive affecting the Union's financial interests, including exchange of information between the Member States and the Commission as well as technical and operational assistance provided by the Commission to the competent national authorities as they may need to facilitate coordination of their investigations. Such assistance should not entail the participation of the Commission in the investigation or prosecution procedures of individual criminal cases conducted by the national authorities. The Court of Auditors and the auditors responsible for auditing the budgets of the Union institutions, bodies, offices and agencies should disclose to the European Anti-Fraud Office (OLAF) and to other competent authorities any fact which could be qualified as a criminal offence under this Directive, and Member States should ensure that national audit bodies within the meaning of Article 59 of Regulation (EU, Euratom) No 966/2012 do the same, in accordance with Article 8 of Regulation (EU, Euratom) No 883/2013. (24) The Commission should report to the European Parliament and to the Council on the measures taken by Member States to comply with this Directive. The report may be accompanied, if necessary, by proposals taking into consideration possible evolutions, in particular regarding the financing of the Union budget. (25) The Convention should be replaced by this Directive for the Member States bound by it. (26) For the application of point (d) of Article 3(4) of Directive (EU) 2015/849 of the European Parliament and of the Council (12), the reference to serious fraud affecting the Union's financial interests as defined in Article 1(1) and Article2(1) of the Convention should be construed as fraud affecting the Union's financial interests as defined in Article 3 and in Article 7(3) of this Directive or, as regards offences against the common VAT system, as defined in Article 2(2) of this Directive. (27) Proper implementation of this Directive by the Member States includes the processing of personal data by the competent national authorities, and the exchange of such data between Member States on the one hand, and between competent Union bodies on the other. The processing of personal data at national level between national competent authorities should be regulated by the acquis of the Union. The exchange of personal data between Member States should be carried out in accordance with Directive (EU) 2016/680 of the European Parliament and of the Council (13). To the extent that the Union institutions, bodies, offices and agencies process personal data, Regulation (EC) No 45/2001 of the European Parliament and of the Council (14) or, where applicable, other Union legal acts regulating the processing of personal data by those bodies, offices and agencies as well as the applicable rules concerning the confidentiality of judicial investigations, should apply. (28) The intended dissuasive effect of the application of criminal law sanctions requires particular caution with regard to fundamental rights. This Directive respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019) and in particular the right to liberty and security, the protection of personal data, the freedom to choose an occupation and right to engage in work, the freedom to conduct a business, the right to property, the right to an effective remedy and to a fair trial, the presumption of innocence and the right of defence, the principles of the legality and proportionality of criminal offences and sanctions, as well as the principle of ne bis in idem. This Directive seeks to ensure full respect for those rights and principles and must be implemented accordingly. (29) Member States should take the necessary measures to ensure the prompt recovery of sums and their transfer to the Union budget, without prejudice to the relevant Union sector-specific rules on financial corrections and recovery of amounts unduly spent. (30) Administrative measures and penalties play an important role in the protection of the Union's financial interests. This Directive does not exempt Member States from the obligation to apply and implement administrative Union measures and penalties within the meaning of Articles 4 and 5 of Regulation (EC, Euratom) No 2988/95. (31) This Directive should oblige Member States to provide in their national law for criminal penalties in respect of the acts of fraud and fraud-related criminal offences affecting the Union's financial interests to which this Directive applies. This Directive should not create obligations regarding the application of such penalties or any other available system of law enforcement to individual cases. Member States may in principle continue to apply administrative measures and penalties in parallel in the area covered by this Directive. In the application of national law transposing this Directive, Member States should, however, ensure that the imposition of criminal sanctions for criminal offences in accordance with this Directive and of administrative measures and penalties does not lead to a breach of the Charter. (32) This Directive should not affect the competences of Member States to structure and organise their tax administration as they see fit to ensure the correct determination, assessment and collection of value added tax, as well as the effective application of VAT law. (33) This Directive applies without prejudice to the provisions on the lifting of the immunities contained in the TFEU, Protocol No 3 on the Statute of the Court of Justice of the European Union and Protocol No 7 on the Privileges and Immunities of the European Union, annexed to the TFEU and to the Treaty on European Union(TEU), and the texts implementing them, or similar provisions incorporated in national law. In the transposition of this Directive into national law as well as in the application of national law transposing this Directive, those privileges and immunities, including the respect for the freedom of the Member's mandate, are fully taken into account. (34) This Directive is without prejudice to the general rules and principles of national criminal law on the application and execution of sentences in accordance with the concrete circumstances in each individual case. (35) Since the objective of this Directive cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective. (36) In accordance with Article 3 and Article 4a(1) of Protocol No 21 on the position of United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, Ireland has notified its wish to take part in the adoption and application of this Directive. (37) In accordance with Articles 1 and 2 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, the United Kingdom is not taking part in the adoption of this Directive and is not bound by it or subject to its application. (38) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application. (39) The European Court of Auditors has been consulted and has adopted an opinion (15), HAVE ADOPTED THIS DIRECTIVE: TITLE I SUBJECT MATTER, DEFINITIONS AND SCOPE Article 1 Subject matter This Directive establishes minimum rules concerning the definition of criminal offences and sanctions with regard to combatting fraud and other illegal activities affecting the Union's financial interests, with a view to strengthening protection against criminal offences which affect those financial interests, in line with the acquis of the Union in this field. Article 2 Definitions and scope 1. For the purposes of this Directive, the following definitions apply: (a) \u2018Union's financial interests\u2019 means all revenues, expenditure and assets covered by, acquired through, or due to: (i) the Union budget; (ii) the budgets of the Union institutions, bodies, offices and agencies established pursuant to the Treaties or budgets directly or indirectly managed and monitored by them; (b) \u2018legal person\u2019 means an entity having legal personality under the applicable law, except for States or public bodies in the exercise of State authority and for public international organisations. 2. In respect of revenue arising from VAT own resources, this Directive shall apply only in cases of serious offences against the common VAT system. For the purposes of this Directive, offences against the common VAT system shall be considered to be serious where the intentional acts or omissions defined in point (d) of Article 3(2) are connected with the territory of two or more Member States of the Union and involve a total damage of at least EUR 10 000 000. 3. The structure and functioning of the tax administration of the Member States are not affected by this Directive. TITLE II CRIMINAL OFFENCES WITH REGARD TO FRAUD AFFECTING THE UNION'S FINANCIAL INTERESTS Article 3 Fraud affecting the Union's financial interests 1. Member States shall take the necessary measures to ensure that fraud affecting the Union's financial interests constitutes a criminal offence when committed intentionally. 2. For the purposes of this Directive, the following shall be regarded as fraud affecting the Union's financial interests: (a) in respect of non-procurement-related expenditure, any act or omission relating to: (i) the use or presentation of false, incorrect or incomplete statements or documents, which has as its effect the misappropriation or wrongful retention of funds or assets from the Union budget or budgets managed by the Union, or on its behalf; (ii) non-disclosure of information in violation of a specific obligation, with the same effect; or (iii) the misapplication of such funds or assets for purposes other than those for which they were originally granted; (b) in respect of procurement-related expenditure, at least when committed in order to make an unlawful gain for the perpetrator or another by causing a loss to the Union's financial interests, any act or omission relating to: (i) the use or presentation of false, incorrect or incomplete statements or documents, which has as its effect the misappropriation or wrongful retention of funds or assets from the Union budget or budgets managed by the Union, or on its behalf; (ii) non-disclosure of information in violation of a specific obligation, with the same effect; or (iii) the misapplication of such funds or assets for purposes other than those for which they were originally granted, which damages the Union's financial interests; (c) in respect of revenue other than revenue arising from VAT own resources referred to in point (d), any act or omission relating to: (i) the use or presentation of false, incorrect or incomplete statements or documents, which has as its effect the illegal diminution of the resources of the Union budget or budgets managed by the Union, or on its behalf; (ii) non-disclosure of information in violation of a specific obligation, with the same effect; or (iii) misapplication of a legally obtained benefit, with the same effect; (d) in respect of revenue arising from VAT own resources, any act or omission committed in cross-border fraudulent schemes in relation to: (i) the use or presentation of false, incorrect or incomplete VAT-related statements or documents, which has as an effect the diminution of the resources of the Union budget; (ii) non-disclosure of VAT-related information in violation of a specific obligation, with the same effect; or (iii) the presentation of correct VAT-related statements for the purposes of fraudulently disguising the non-payment or wrongful creation of rights to VAT refunds. Article 4 Other criminal offences affecting the Union's financial interests 1. Member States shall take the necessary measures to ensure that money laundering as described in Article 1(3) of Directive (EU) 2015/849 involving property derived from the criminal offences covered by this Directive constitutes a criminal offence. 2. Member States shall take the necessary measures to ensure that passive and active corruption, when committed intentionally, constitute criminal offences. (a) For the purposes of this Directive, \u2018passive corruption\u2019 means the action of a public official who, directly or through an intermediary, requests or receives advantages of any kind, for himself or for a third party, or accepts a promise of such an advantage, to act or to refrain from acting in accordance with his duty or in the exercise of his functions in a way which damages or is likely to damage the Union's financial interests. (b) For the purposes of this Directive, \u2018active corruption\u2019 means the action of a person who promises, offers or gives, directly or through an intermediary, an advantage of any kind to a public official for himself or for a third party for him to act or to refrain from acting in accordance with his duty or in the exercise of his functions in a way which damages or is likely to damage the Union's financial interests. 3. Member States shall take the necessary measures to ensure that misappropriation, when committed intentionally, constitutes a criminal offence. For the purposes of this Directive, \u2018misappropriation\u2019 means the action of a public official who is directly or indirectly entrusted with the management of funds or assets to commit or disburse funds or appropriate or use assets contrary to the purpose for which they were intended in any way which damages the Union's financial interests. 4. For the purposes of this Directive, \u2018public official\u2019 means: (a) a Union official or a national official, including any national official of another Member State and any national official of a third country: (i) \u2018Union official\u2019 means a person who is: \u2014 an official or other servant engaged under contract by the Union within the meaning of the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Union laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (16) (the \u2018Staff Regulations\u2019), or \u2014 seconded to the Union by a Member State or by any public or private body, who carries out functions equivalent to those performed by Union officials or other servants. Without prejudice to the provisions on privileges and immunities contained in Protocols No 3 and No 7, Members of the Union institutions, bodies, offices and agencies, set up in accordance with the Treaties and the staff of such bodies shall be assimilated to Union officials, inasmuch as the Staff Regulations do not apply to them; (ii) \u2018national official\u2019 shall be understood by reference to the definition of \u2018official\u2019 or \u2018public official\u2019 in the national law of the Member State or third country in which the person in question carries out his or her functions. Nevertheless, in the case of proceedings involving a national official of a Member State, or a national official of a third country, initiated by another Member State, the latter shall not be bound to apply the definition of \u2018national official\u2019 except insofar as that definition is compatible with its national law. The term \u2018national official\u2019 shall include any person holding an executive, administrative or judicial office at national, regional or local level. Any person holding a legislative office at national, regional or local level shall be assimilated to a national official; (b) any other person assigned and exercising a public service function involving the management of or decisions concerning the Union's financial interests in Member States or third countries. TITLE III GENERAL PROVISIONS RELATING TO FRAUD AND OTHER CRIMINAL OFFENCES AFFECTING THE UNION'S FINANCIAL INTERESTS Article 5 Incitement, aiding and abetting, and attempt 1. Member States shall take the necessary measures to ensure that inciting, and aiding and abetting the commission of any of the criminal offences referred to in Articles 3 and 4 are punishable as criminal offences. 2. Member States shall take the necessary measures to ensure that an attempt to commit any of the criminal offences referred to in Article 3 and Article 4(3) is punishable as a criminal offence. Article 6 Liability of legal persons 1. Member States shall take the necessary measures to ensure that legal persons can be held liable for any of the criminal offences referred to in Articles 3, 4 and 5 committed for their benefit by any person, acting either individually or as part of an organ of the legal person, and having a leading position within the legal person, based on: (a) a power of representation of the legal person; (b) an authority to take decisions on behalf of the legal person; or (c) an authority to exercise control within the legal person. 2. Member States shall also take the necessary measures to ensure that legal persons can be held liable where the lack of supervision or control by a person referred to in paragraph 1 of this Article has made possible the commission, by a person under its authority, of any of the criminal offences referred to in Article 3, 4 or 5 for the benefit of that legal person. 3. Liability of legal persons under paragraphs 1 and 2 of this Article shall not exclude the possibility of criminal proceedings against natural persons who are perpetrators of the criminal offences referred to in Articles 3 and 4 or who are criminally liable under Article 5. Article 7 Sanctions with regard to natural persons 1. As regards natural persons, Member States shall ensure that the criminal offences referred to in Articles 3, 4 and 5 are punishable by effective, proportionate and dissuasive criminal sanctions. 2. Member States shall take the necessary measures to ensure that the criminal offences referred to in Articles 3 and 4 are punishable by a maximum penalty which provides for imprisonment. 3. Member States shall take the necessary measures to ensure that the criminal offences referred to in Articles 3 and 4 are punishable by a maximum penalty of at least four years of imprisonment when they involve considerable damage or advantage. The damage or advantage resulting from the criminal offences referred to in points (a), (b) and (c) of Article 3(2) and in Article 4 shall be presumed to be considerable where the damage or advantage involves more than EUR 100 000. The damage or advantage resulting from the criminal offences referred to in point (d) of Article 3(2) and subject to Article 2(2) shall always be presumed to be considerable. Member States may also provide for a maximum sanction of at least four years of imprisonment in other serious circumstances defined in their national law. 4. Where a criminal offence referred to in point (a), (b) or (c) of Article 3(2) or in Article 4 involves damage of less than EUR 10 000 or an advantage of less than EUR 10 000, Member States may provide for sanctions other than criminal sanctions. 5. Paragraph 1 shall be without prejudice to the exercise of disciplinary powers by the competent authorities against public officials. Article 8 Aggravating circumstance Member States shall take the necessary measures to ensure that where a criminal offence referred to in Article 3, 4 or 5 is committed within a criminal organisation in the sense of Framework Decision 2008/841/JHA, this shall be considered to be an aggravating circumstance. Article 9 Sanctions with regard to legal persons Member States shall take the necessary measures to ensure that a legal person held liable pursuant to Article 6 is subject to effective, proportionate and dissuasive sanctions, which shall include criminal or non-criminal fines and may include other sanctions, such as: (a) exclusion from entitlement to public benefits or aid; (b) temporary or permanent exclusion from public tender procedures; (c) temporary or permanent disqualification from the practice of commercial activities; (d) placing under judicial supervision; (e) judicial winding-up; (f) temporary or permanent closure of establishments which have been used for committing the criminal offence. Article 10 Freezing and confiscation Member States shall take the necessary measures to enable the freezing and confiscation of instrumentalities and proceeds from the criminal offences referred to in Articles 3, 4 and 5. Member States bound by Directive 2014/42/EU of the European Parliament and of the Council (17) shall do so in accordance with that Directive. Article 11 Jurisdiction 1. Each Member State shall take the necessary measures to establish its jurisdiction over the criminal offences referred to in Articles 3, 4 and 5 where: (a) the criminal offence is committed in whole or in part within its territory; or (b) the offender is one of its nationals. 2. Each Member State shall take the necessary measures to establish its jurisdiction over the criminal offences referred to in Articles 3, 4 and 5 where the offender is subject to the Staff Regulations at the time of the criminal offence. Each Member State may refrain from applying the rules on jurisdiction established in this paragraph or may apply them only in specific cases or only where specific conditions are fulfilled and shall inform the Commission thereof. 3. A Member State shall inform the Commission where it decides to extend its jurisdiction to criminal offences referred to in Article 3, 4 or 5 which have been committed outside its territory in any of the following situations: (a) the offender is a habitual resident in its territory; (b) the criminal offence is committed for the benefit of a legal person established in its territory; or (c) the offender is one of its officials who acts in his or her official duty. 4. In cases referred to in point (b) of paragraph 1, Member States shall take the necessary measures to ensure that the exercise of their jurisdiction is not subject to the condition that a prosecution can be initiated only following a report made by the victim in the place where the criminal offence was committed, or a denunciation from the State of the place where the criminal offence was committed. Article 12 Limitation periods for criminal offences affecting the Union's financial interests 1. Member States shall take the necessary measures to provide for a limitation period that enables the investigation, prosecution, trial and judicial decision of criminal offences referred to in Articles 3, 4 and 5 for a sufficient period of time after the commission of those criminal offences, in order for those criminal offences to be tackled effectively. 2. Member States shall take the necessary measures to enable the investigation, prosecution, trial and judicial decision of criminal offences referred to in Articles 3, 4 and 5 which are punishable by a maximum sanction of at least four years of imprisonment, for a period of at least five years from the time when the offence was committed. 3. By way of derogation from paragraph 2, Member States may establish a limitation period that is shorter than five years, but not shorter than three years, provided that the period may be interrupted or suspended in the event of specified acts. 4. Member States shall take the necessary measures to enable the enforcement of: (a) a penalty of more than one year of imprisonment; or alternatively (b) a penalty of imprisonment in the case of a criminal offence which is punishable by a maximum sanction of at least four years of imprisonment, imposed following a final conviction for a criminal offence referred to in Article 3, 4 or 5, for at least five years from the date of the final conviction. That period may include extensions of the limitation period arising from interruption or suspension. Article 13 Recovery This Directive shall be without prejudice to the recovery of the following: (1) at Union level of sums unduly paid in the context of the commission of the criminal offences referred to in point (a), (b) or (c) of Article 3(2), or in Article 4 or 5; (2) at national level, of any VAT not paid in the context of the commission of the criminal offences referred in point (d) of Article 3(2), or in Article 4 or 5. Article 14 Interaction with other applicable legal acts of the Union The application of administrative measures, penalties and fines as laid down in Union law, in particular those within the meaning of Articles 4 and 5 of Regulation (EC, Euratom) No 2988/95, or in national law adopted in compliance with a specific obligation under Union law, shall be without prejudice to this Directive. Member States shall ensure that any criminal proceedings initiated on the basis of national provisions implementing this Directive do not unduly affect the proper and effective application of administrative measures, penalties and fines that cannot be equated to criminal proceedings, laid down in Union law or national implementing provisions. TITLE IV FINAL PROVISIONS Article 15 Cooperation between the Member States and the Commission (OLAF) and other Union institutions, bodies, offices or agencies 1. Without prejudice to the rules on cross-border cooperation and mutual legal assistance in criminal matters, the Member States, Eurojust, the European Public Prosecutor's Office and the Commission shall, within their respective competences, cooperate with each other in the fight against the criminal offences referred to in Articles 3, 4 and 5. To that end the Commission, and where appropriate, Eurojust, shall provide such technical and operational assistance as the competent national authorities need to facilitate coordination of their investigations. 2. The competent authorities in the Member States may, within their competences, exchange information with the Commission so as to make it easier to establish the facts and to ensure effective action against the criminal offences referred to in Articles 3, 4 and 5. The Commission and the competent national authorities shall take into account in each specific case the requirements of confidentiality and the rules on data protection. Without prejudice to national law on access to information, a Member State may, to that end, when supplying information to the Commission, set specific conditions covering the use of information, whether by the Commission or by another Member State to which the information is passed. 3. The Court of Auditors and auditors responsible for auditing the budgets of the Union institutions, bodies, offices and agencies established pursuant to the Treaties, and the budgets managed and audited by the institutions, shall disclose to OLAF and to other competent authorities any fact of which they become aware when carrying out their duties, which could be qualified as a criminal offence referred to in Article 3, 4 or 5. Member States shall ensure that national audit bodies do the same. Article 16 Replacement of the Convention on the protection of the European Communities' financial interests The Convention on the protection of the European Communities' financial interests of 26 July 1995, including the Protocols thereto of 27 September 1996, of 29 November 1996 and of 19 June 1997, is hereby replaced by this Directive for the Member States bound by it, with effect from 6 July 2019. For the Member States bound by this Directive, references to the Convention shall be construed as references to this Directive. Article 17 Transposition 1. Member States shall adopt and publish, by 6 July 2019, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those measures to the Commission. They shall apply those measures from 6 July 2019. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that, for the Member States bound by this Directive, references in existing laws, regulations and administrative provisions to the Convention replaced by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 18 Reporting and assessment 1. The Commission shall by 6 July 2021 submit a report to the European Parliament and the Council, assessing the extent to which the Member States have taken the necessary measures in order to comply with this Directive. 2. Without prejudice to reporting obligations laid down in other Union legal acts, Member States shall, on an annual basis, submit the following statistics on the criminal offences referred to in Articles 3, 4 and 5 to the Commission, if they are available at a central level in the Member State concerned: (a) the number of criminal proceedings initiated, dismissed, resulting in an acquittal, resulting in a conviction and ongoing; (b) the amounts recovered following criminal proceedings and the estimated damage. 3. The Commission shall, by 6 July 2024 and taking into account its report submitted pursuant to paragraph 1 and the Member States' statistics submitted pursuant to paragraph 2, submit a report to the European Parliament and to the Council, assessing the impact of national law transposing this Directive on the prevention of fraud to the Union's financial interests. 4. The Commission shall, by 6 July 2022 and on the basis of the statistics submitted by Member States, pursuant to paragraph 2, submit a report to the European Parliament and to the Council, assessing, with regard to the general objective to strengthen the protection of the Union's financial interests, whether: (a) the threshold indicated in Article 2(2) is appropriate; (b) the provisions relating to limitation periods as referred to in Article 12 are sufficiently effective; (c) this Directive effectively addresses cases of procurement fraud. 5. The reports referred to in paragraphs 3 and 4 shall be accompanied, if necessary, by a legislative proposal, which may include a specific provision on procurement fraud. Article 19 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 20 Addressees This Directive is addressed to the Member States in accordance with the Treaties. Done at Strasbourg, 5 July 2017. For the European Parliament The President A. TAJANI For the Council The President M. MAASIKAS (1) OJ C 391, 18.12.2012, p. 134. (2) Position of the European Parliament of 16 April 2014 (not yet published in the Official Journal) and position of the Council at first reading of 25 April 2017 (OJ C 184, 9.6.2017, p. 1). Position of the European Parliament of 5 July 2017 (not yet published in the Official Journal). (3) OJ C 316, 27.11.1995, p. 48. (4) OJ C 313, 23.10.1996, p. 1. (5) OJ C 151, 20.5.1997, p. 1. (6) OJ C 221, 19.7.1997, p. 11. (7) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities' financial interests (OJ L 312, 23.12.1995, p. 1). (8) Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1). (9) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (10) Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (OJ L 300, 11.11.2008, p. 42). (11) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (12) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73). (13) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (14) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (15) OJ C 383, 12.12.2012, p. 1. (16) OJ L 56, 4.3.1968, p. 1. (17) Directive 2014/42/EU of the European Parliament and of the Council of 3 April 2014 on the freezing and confiscation of instrumentalities and proceeds of crime in the European Union (OJ L 127, 29.4.2014, p. 39).", "summary": "Fight against fraud to the EU\u2019s financial interests by means of criminal law Fight against fraud to the EU\u2019s financial interests by means of criminal law SUMMARY OF: Directive (EU) 2017/1371 \u2014 using criminal law to protect the EU\u2019s financial interests WHAT IS THE AIM OF THE DIRECTIVE? To create a stronger and more harmonised system, with minimum common rules, to fight crime affecting the EU budget. To better protect the EU\u2019s financial interests and taxpayers\u2019 money across the EU. KEY POINTS Scope The directive concerns: fraud and other criminal offences, such as corruption, misappropriation or money laundering, affecting the EU\u2019s financial interests \u2014 i.e. the EU budget, the budgets of the EU institutions, bodies, offices and agencies established by the treaties, or the budgets directly or indirectly managed and monitored by them; \u2018serious offences\u2019 against the common value added tax (VAT) system, like VAT carousels* (offences considered to be serious when they are connected with the territory of two or more EU countries and involve a total damage of at least \u20ac10,000,000). It also sets out common rules on sanctions and limitation periods in relation to the criminal offences covered by this directive. Definitions Each of the following offences is given a definition at EU level: fraud committed intentionally \u2014 what is regarded as fraud in respect of expenditure as procurement and non-procurement as well as of revenue arising from VAT own resources and other revenue; money laundering as defined in Directive (EU) 2015/849; passive and active corruption committed intentionally; misappropriation committed intentionally. What is meant by \u2018public officials\u2019 \u2014 EU and national (including in EU countries) \u2014 is specified in the definitions of money laundering, corruption and misappropriation. The criminal offences as defined in the directive fall within the material competence of the newly established European Public Prosecutor\u2019s Office, an independent EU body empowered to investigate and prosecute these crimes and bring them to judgment before competent national courts. Common approach In all EU countries (except Denmark and the United Kingdom (1)): these offences are all to be punished as criminal offences, as are their attempt as well as their incitement, aiding and abetting; legal persons* should be held liable for any of the criminal offences committed for their benefit \u2014 not excluding the possibility of criminal proceedings against natural persons who are the perpetrators or who are solely responsible. Sanctions The directive provides for minimum \u2018effective, proportionate and dissuasive\u2019 criminal sanctions. These include a maximum penalty of at least 4 years of imprisonment: where the financial damage to the EU budget is above the threshold of \u20ac100.000; in any case of serious offences against the common VAT system; other serious circumstances defined under national law. Where a criminal offence involves damages of below \u20ac10.000, EU countries may introduce sanctions that are not criminal. Regarding legal persons, the directive envisages various other types of sanctions in addition to fines (criminal and non-criminal). Offences committed within a criminal organisation within the meaning of Framework Decision 2008/841/JHA constitute an aggravating circumstance. These sanctions do not exclude: the possibility of more severe sanctions in national legislation; the exercise of disciplinary powers by the competent authorities against public officials. The directive also deals with the following: the freezing and confiscation of means and proceeds from the criminal offences that affect the EU budget; establishing jurisdiction for such offences; minimum limitation periods enabling investigations and prosecutions as well as allowing the enforcement of the penalties imposed following a conviction for a commission of these offences. Cooperation between EU countries and EU institutions, bodies, offices and agencies The EU countries, Eurojust, the European Public Prosecutor\u2019s Office and the Commission\u2019s European Anti-Fraud Office (OLAF) must cooperate against the criminal offences covered by this directive. OLAF and, where appropriate, Eurojust provide technical and operational assistance to facilitate the coordination of the EU countries\u2019 investigations. If the Court of Auditors and auditors responsible for auditing the budgets of the EU institutions, bodies, offices and agencies or other budgets managed and audited by the institutions, find anything that could qualify as a criminal offence under this directive, they must inform the European Public Prosecutor\u2019s Office, OLAF and the other competent authorities. EU countries must ensure that national audit bodies do the same. FROM WHEN DOES THE DIRECTIVE APPLY? EU countries have to incorporate it into national law by 6 July 2019. BACKGROUND Article 325 of the Treaty on the Functioning of the European Union obliges the EU and EU countries to counter fraud and any other illegal activities affecting the EU\u2019s financial interests with measures that act as a deterrent. More than 90% of the EU budget is managed nationally. Damage to the EU budget resulting from crime and other illegal activities amounts to hundreds of millions of euros each year and is of serious concern. In 2011, the Commission adopted a communication which contained proposals to improve the protection of EU financial interests (see IP/11/644). For more information: EU anti-fraud policy (European Commission \u2014 OLAF) EU criminal law policy (European Commission) \u2018Commission steps up its efforts in fighting fraud against the EU budget\u2019 \u2014 press release (European Commission). KEY TERMS VAT carousel: where fraudsters import goods VAT-free from other EU countries, then sell the goods to domestic buyers, charging them VAT. The sellers then disappear without paying the VAT to the tax authorities. Legal person: an entity recognised by the law as being entitled to rights and duties in the same way as a natural or human person, the common example being a company. MAIN DOCUMENT Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, pp. 29-41) RELATED DOCUMENTS Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union (OJ C 202, 7.6.2016, pp. 1-388) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, pp. 1-71) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, pp. 73-117) Directive 2014/42/EU of the European Parliament and of the Council of 3 April 2014 on the freezing and confiscation of instrumentalities and proceeds of crime in the European Union (OJ L 127, 29.4.2014, pp. 39-50) See consolidated version. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the protection of the financial interests of the European Union by criminal law and by administrative investigations \u2014 An integrated policy to safeguard taxpayers' money (COM(2011) 293 final, 26.5.2011) Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (OJ L 300, 11.11.2008, pp. 42-45) Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, pp. 1-118) See consolidated version. Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, pp. 1-4) Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities\u2019 financial interests (OJ C 316, 27.11.1995, pp. 49-57) last update 06.12.2017(1) The United Kingdom withdraws from the European Union and becomes a third country (non-EU country) as of 1 February 2020."}
{"article": "19.5.2015 EN Official Journal of the European Union L 123/1 REGULATION (EU) 2015/751 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2015 on interchange fees for card-based payment transactions (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Fragmentation of the internal market is detrimental to competitiveness, growth and job creation within the Union. Eliminating direct and indirect obstacles to the proper functioning and completion of an integrated market for electronic payments, with no distinction between national and cross-border payments, is necessary for the proper functioning of the internal market. (2) Directive 2007/64/EC of the European Parliament and of the Council (4) has provided a legal foundation for the creation of a Union-wide internal market for payments as it substantially facilitated the activity of payment service providers, creating uniform rules with respect to the provision of payment services. (3) Regulation (EC) No 924/2009 of the European Parliament and of the Council (5) established the principle that charges paid by users for a cross-border payment in euro are the same as for the corresponding payment within a Member State including card-based payment transactions covered by this Regulation. (4) Regulation (EU) No 260/2012 of the European Parliament and of the Council (6) provided the rules for the functioning of credit transfers and direct debits in euro in the internal market but excluded card-based payment transactions from its scope. (5) Directive 2011/83/EU of the European Parliament and of the Council (7) aims to harmonise certain rules on contracts concluded between consumers and traders, including rules on fees for the use of means of payment, on the basis of which Member States prohibit traders from charging consumers, in respect of the use of a given means of payment, fees that exceed the cost borne by the trader for the use of such means. (6) Secure, efficient, competitive and innovative electronic payments are crucial if consumers, merchants and companies are to enjoy the full benefits of the internal market, especially as the world moves towards e-commerce. (7) Some Member States have issued or are preparing legislation to regulate directly or indirectly interchange fees and covering a number of issues, including caps on interchange fees at various levels, merchant fees, the \u2018Honour All Cards\u2019 rule and steering measures. The existing administrative decisions in some Member States vary significantly. To make the levels of interchange fees more consistent, a further introduction of regulatory measures at national level aimed at addressing the levels of, or discrepancies between, those fees is anticipated. Such national measures would be likely to lead to significant barriers to the completion of the internal market in the area of card-based payments and internet and mobile payments based on cards and would therefore hinder the freedom to provide services. (8) Payment cards are the most frequently used electronic payment instrument for retail purchases. However, integration of the Union payment card market is far from complete as many payment solutions cannot develop beyond their national borders and new pan-Union players are prevented from entering the market. There is a need to remove obstacles to the efficient functioning of the card market, including in the area of card-based payments and internet and mobile payments based on cards. (9) To enable the internal market to function effectively, the use of electronic payments should be promoted and facilitated to the benefit of merchants and consumers. Cards and other electronic payments can be used in a more versatile manner, including possibilities to pay online in order to take advantage of the internal market and e-commerce, whilst electronic payments also provide merchants with potentially secure payments. Card-based payment transactions instead of payments in cash could therefore be beneficial for merchants and consumers, provided that the fees for the use of the payment card schemes are set at an economically efficient level, whilst contributing to fair competition, innovation and market entry of new operators. (10) Interchange fees are usually applied between the card-acquiring payment service providers and the card-issuing payment service providers belonging to a certain payment card scheme. Interchange fees are a main part of the fees charged to merchants by acquiring payment service providers for every card-based payment transaction. Merchants in turn incorporate those card costs, like all their other costs, in the general prices of goods and services. Competition between payment card schemes to convince payment service providers to issue their cards leads to higher rather than lower interchange fees on the market, in contrast with the usual price-disciplining effect of competition in a market economy. In addition to a consistent application of the competition rules to interchange fees, regulating such fees would improve the functioning of the internal market and contribute to reducing transaction costs for consumers. (11) The existing wide variety of interchange fees and their level prevent the emergence of new pan-Union players on the basis of business models with lower or no interchange fees, to the detriment of potential economies of scale and scope and their resulting efficiencies. This has a negative impact on merchants and consumers and prevents innovation. As pan-Union players would, as a minimum, have to offer issuing banks the highest level of interchange fee prevailing in the market they want to enter, it also results in persisting market fragmentation. Existing domestic schemes with lower or no interchange fees may also be forced to exit the market because of the pressure from banks to obtain higher interchange fees revenues. As a result, consumers and merchants face restricted choice, higher prices and lower quality of payment services, while their ability to use pan-Union payment solutions is also restricted. In addition, merchants cannot overcome the fee differences by making use of card acceptance services offered by banks in other Member States. Specific rules applied by the payment card schemes require the application of the interchange fee of the \u2018point of sale\u2019 (country of the merchant) for each payment transaction, on the basis of their territorial licensing policies. This requirement prevents acquirers from successfully offering their services on a cross-border basis. It can also prevent merchants from reducing their payment costs to the benefit of consumers. (12) The application of existing legislation by the Commission and national competition authorities has not been able to redress this situation. (13) Therefore, to avoid fragmentation of the internal market and significant distortions of competition through diverging laws and administrative decisions, there is a need, in line with Article 114 of the Treaty on the Functioning of the European Union, to take measures to address the problem of high and divergent interchange fees, to allow payment service providers to provide their services on a cross-border basis and for consumers and merchants to use cross-border services. (14) The application of this Regulation should be without prejudice to the application of Union and national competition rules. It should not prevent Member States from maintaining or introducing lower caps or measures of equivalent object or effect through national legislation. (15) In order to facilitate the smooth functioning of an internal market for card-based payments and internet and mobile payments based on cards, to the benefit of consumers and merchants, this Regulation should apply to cross-border and domestic issuing and acquiring of card-based payment transactions. If merchants can choose an acquirer outside their own Member State (\u2018cross-border acquiring\u2019), which will be facilitated by the imposition of the same maximum level of both domestic and cross-border interchange fees for acquired transactions and the prohibition of territorial licensing, it should be possible to provide the necessary legal clarity and to prevent distortions of competition between payment card schemes. (16) As a consequence of unilateral undertakings and commitments accepted in the framework of competition proceedings, many cross-border card-based payment transactions in the Union are already carried out respecting the maximum interchange fees. In order to provide for fair competition in the market for acquiring services, the provisions relating to cross-border and to domestic transactions should apply simultaneously and within a reasonable period after the entry into force of this Regulation, taking account of the difficulty and complexity of the migration of payment card schemes, which this Regulation necessitates. (17) There are two main types of credit cards available on the market. With deferred debit cards, the total amount of transactions is debited from the cardholder account at a pre-agreed specific date, usually once a month, without interest to be paid. With other credit cards, the cardholder can use a credit facility in order to reimburse part of the amounts due at a later date than specified, together with interest or other costs. (18) All debit and credit card-based payment transactions should be subject to a maximum interchange fee rate. (19) The impact assessment shows that a prohibition of interchange fees for debit card transactions would be beneficial for card acceptance, card usage, the development of the single market and generate more benefits to merchants and consumers than a cap set at any higher level. Moreover, it would avoid negative effects resulting from a higher cap in those national schemes that have very low or zero interchange fees for debit transactions due to cross-border expansion or new market entrants increasing fee levels to the level of the cap. A ban on interchange fees for debit card transactions also addresses the threat of exporting the interchange fee model to new, innovative payment services such as mobile and online systems. (20) The caps in this Regulation are based on the so-called \u2018Merchant Indifference Test\u2019 developed in economic literature, which identifies the fee level a merchant would be willing to pay if the merchant were to compare the cost of the customer's use of a payment card with those of non-card (cash) payments (taking into account the fee for service paid to acquiring banks, i.e. the merchant service charge and the interchange fee). It thereby stimulates the use of efficient payment instruments through the promotion of those cards that provide higher transactional benefits, while at the same time preventing disproportionate merchant fees, which would impose hidden costs on other consumers. Excessive merchant fees might otherwise arise due to the collective interchange fee arrangements, as merchants are reluctant to turn down costly payment instruments for fear of losing business. Experience has shown that those levels are proportionate, as they do not call into question the operation of international card schemes and payment service providers. They also provide benefits for merchants and consumers and provide legal certainty. (21) Nevertheless, as shown in the impact assessment, in certain Member States interchange fees have developed so as to allow consumers to benefit from efficient debit card markets in terms of card acceptance and card usage with lower interchange fees than the merchant indifference level. Member States should therefore be able to establish lower interchange fees for domestic debit card transactions. (22) In addition, to ensure that debit card fees are set at an economically efficient level, taking into account the structure of domestic debit card markets, the possibility to express interchange fee caps as a flat rate should be maintained. A flat rate may also promote the use of card-based payments of small value amounts (\u2018micropayments\u2019). It should also be possible to apply such a flat rate in combination with a percentage rate, provided that the sum of such interchange fees does not exceed the specified percentage of the total annual transaction value at domestic level within each payment card scheme. Furthermore it should be possible to define a lower per transaction percentage interchange fee cap, and to impose a fixed maximum fee amount as a limit to the fee amount resulting from the applicable per transaction percentage rate. (23) Furthermore, taking into account that this Regulation undertakes harmonisation for the first time of interchange fees in a context where existing debit card schemes and interchange fees are very different, it is necessary to provide for flexibility for domestic payment cards markets. Therefore, during a reasonable transition period, in relation to domestic debit card transactions, Member States should be able to apply to all domestic debit card transactions within each payment card scheme a weighted average interchange fee of no more than the 0,2 % of the annual average transaction value of all domestic debit card transactions within each payment card scheme. In relation to the interchange fee cap calculated on the annual average transaction value within one payment card scheme, it is sufficient that a payment service provider participates in a payment card scheme (or some other type of agreements among payment service providers) in which, for all domestic debit card transactions, a weighted average interchange fee of no more than the 0,2 % is applied. Here, too, a flat fee or a percentage fee or a combination of the two can be applied provided that the weighted average maximum cap is respected. (24) In order to define the relevant interchange fee caps for domestic debit card transactions, it is appropriate to allow national competent authorities entitled to ensure compliance with this Regulation to collect information regarding the volume and value of all debit card transactions within a payment card scheme or of the debit card transactions pertaining to one or more payment service providers. As a consequence, payment card schemes and payment service providers should be obliged to provide relevant data to national competent authorities as specified by those authorities and in accordance with the time limits set by them. Reporting obligations should extend to payment service providers such as issuers or acquirers and not only to payment card schemes, in order to ensure that any relevant information is made available to the competent authorities which should, in any case, be able to require that such information is collected through the payment card scheme. Moreover, it is important that Member States ensure an adequate level of disclosure of the relevant information concerning the applicable interchange fee caps. In light of the fact that payment card schemes are generally not payment service providers subject to prudential supervision, competent authorities may require that the information sent by these entities is certified by an independent auditor. (25) Some payment instruments at domestic level enable the payer to initiate card-based payment transactions that are not distinguishable as debit or credit card transactions by the payment card scheme. The choices made by the cardholder are unknown to the payment card scheme and to the acquirer; as a consequence, the payment card scheme does not have the possibility of applying the different caps imposed by this Regulation for debit and credit card transactions, which are distinguishable on the basis of the timing agreed for the debiting of the payment transactions. Taking into account the need to preserve the functionality of the existing business models while avoiding unjustified or excessive costs of legal compliance and, at the same time, considering the importance of ensuring an adequate level playing field between the different categories of payment cards, it is appropriate to apply the same rule provided by this Regulation for the debit card transactions to such domestic \u2018universal cards\u2019 payment transactions. Nevertheless, a longer time period for adaptation should be left to those payment instruments. Therefore, by way of exception and during a transition period of 18 months after the entry into force of this Regulation, Member States should be able to define a maximum share of domestic \u2018universal cards\u2019 payment transactions which are considered as being equivalent to credit card transactions. For example, the credit card cap could be applied to the defined share of the total value of the transactions for merchants or acquirers. The mathematical result of the provisions would then be equivalent to the application of a single interchange fee cap on domestic payment transactions carried out with universal cards. (26) This Regulation should cover all transactions where the payer's payment service provider and the payee's payment service provider are located in the Union. (27) In accordance with the principle of technological neutrality set out in the Digital Agenda for Europe, this Regulation should apply to card-based payment transactions regardless of the environment in which this transaction takes place, including through retail payment instruments and services which can be off-line, on-line or mobile. (28) Card-based payment transactions are generally carried out on the basis of two main business models, so-called \u2018three party payment card schemes\u2019 (cardholder \u2014 acquiring and issuing scheme \u2014 merchant) and \u2018four party payment card schemes\u2019 (cardholder \u2014 issuing bank \u2014 acquiring bank \u2014 merchant). Many four party payment card schemes use an explicit interchange fee, which is mostly multilateral. To acknowledge the existence of implicit interchange fees and contribute to the creation of a level playing field, three party payment card schemes using payment service providers as issuers or acquirers should be considered as four party payment card schemes and should follow the same rules, whilst transparency and other measures related to business rules should apply to all providers. However, taking into account the specificities which exist for such three party schemes, it is appropriate to allow for a transitional period during which Member States may decide not to apply the rules concerning the interchange fee cap if such schemes have a very limited market share in the Member State concerned. (29) The issuing service is based on a contractual relationship between the issuer of the payment instrument and the payer, irrespective of whether the issuer is holding the funds on behalf of the payer. The issuer makes payment cards available to the payer, authorises transactions at terminals or their equivalent and may guarantee payment to the acquirer for transactions that are in conformity with the rules of the relevant scheme. Therefore, the mere distribution of payment cards or technical services, such as the mere processing and storage of data, does not constitute issuing. (30) The acquiring service constitutes a chain of operations from the initiation of a card-based payment transaction to the transfer of the funds to the payment account of the payee. Depending on the Member State and the business model in place, the acquiring service is organised differently. Therefore the payment service provider paying the interchange fee does not always contract directly with the payee. Intermediaries providing part of the acquiring services but without direct contractual relationship with payees should nevertheless be covered in the definition of acquirer under this Regulation. The acquiring service is provided irrespective of whether the acquirer is holding the funds on behalf of the payee. Technical services, such as the mere processing and storage of data or the operation of terminals, do not constitute acquiring. (31) It is important to ensure that the provisions concerning the interchange fees to be paid or received by payment service providers are not circumvented by alternative flows of fees to issuers. To avoid this, the \u2018net compensation\u2019 of fees paid or received by the issuer, including possible authorisation charges, from or to a payment card scheme, an acquirer or any other intermediary should be considered as the interchange fee. When calculating the interchange fee, for the purpose of checking whether circumvention is taking place the total amount of payments or incentives received by an issuer from a payment card scheme with respect to the regulated transactions less the fees paid by the issuer to the payment card scheme should be taken into account. Payments, incentives and fees considered could be direct (i.e. volume-based or transaction-specific) or indirect (including marketing incentives, bonuses, rebates for meeting certain transaction volumes). In checking whether circumvention of the provisions of this Regulation is taking place, issuers' profits resulting from special programmes carried out jointly by issuers and payment card schemes and revenue from processing, licensing and other fees providing revenue to payment card schemes should, in particular, be taken into account. As appropriate, and if corroborated by further objective elements, the issuance of payment cards in third countries could also be taken into account when assessing potential circumvention of this Regulation. (32) Consumers tend to be unaware of the fees paid by merchants for the payment instrument they use. At the same time, a series of incentivising practices applied by issuers (such as travel vouchers, bonuses, rebates, charge backs, free insurances, etc.) may steer consumers towards the use of payment instruments, thereby generating high fees for issuers. To counter this, the measures imposing restrictions on interchange fees should only apply to payment cards that have become mass products and merchants generally have difficulty refusing due to their widespread issuance and use (i.e. consumer debit and credit cards). In order to enhance effective market functioning in the non-regulated parts of the sector and to limit the transfer of business from the regulated to the non-regulated parts of the sector, it is necessary to adopt a series of measures, including the separation of scheme and infrastructure, the steering of the payer by the payee and the selective acceptance of payment instruments by the payee. (33) A separation of scheme and infrastructure should allow all processors to compete for customers of the schemes. As the cost of processing is a significant part of the total cost of card acceptance, it is important for this part of the value chain to be opened to effective competition. On the basis of the separation of scheme and infrastructure, card schemes and processing entities should be independent in terms of accounting, organisation and decision-making process. They should not discriminate, for instance by providing each other with preferential treatment or privileged information which is not available to their competitors on their respective market segment, imposing excessive information requirements on their competitor in their respective market segment, cross-subsidising their respective activities or having shared governance arrangements. Such discriminatory practises contribute to market fragmentation, negatively impact market entry by new players and prevent pan-Union players from emerging, hence hindering the completion of the internal market in the area of card-based payments and internet and mobile payments based on cards, to the detriment of merchants, companies and consumers. (34) Scheme rules applied by payment card schemes and practices applied by payment service providers tend to keep merchants and consumers ignorant about fee differences and reduce market transparency, for instance by \u2018blending\u2019 fees or prohibiting merchants from choosing a cheaper card brand on co-badged cards or steering consumers to the use of such cheaper cards. Even if merchants are aware of the different costs, the scheme rules often prevent them from acting to reduce the fees. (35) Payment instruments entail different costs to the payee, with certain instruments being more expensive than others. Except where a particular payment instrument is imposed by law for certain categories of payments or cannot be refused due to its legal tender status, the payee should be free, in accordance with Directive 2007/64/EC, to steer payers towards the use of a specific payment instrument. Card schemes and payment service providers impose several restrictions on payees in this respect, examples of which include restrictions on the refusal by the payee of specific payment instruments for low amounts, on the provision of information to the payer on the fees incurred by the payee for specific payment instruments or limitation imposed on the payee of the number of tills in his or her shop which accept specific payment instruments. Those restrictions should be abolished. (36) In situations where the payee steers the payer towards the use of a specific payment instrument, no charges should be requested by the payee from the payer for the use of payment instruments of which interchange fees are regulated within the scope of this Regulation, as in such situations the advantages of surcharging become limited while creating complexity in the market. (37) The \u2018Honour all Cards\u2019 rule is a twofold obligation imposed by issuers and payment card schemes for payees to accept all the cards of the same brand, irrespective of the different costs of these cards (the \u2018Honour all Products\u2019 element) and irrespective of the individual issuing bank which has issued the card (the \u2018Honour all Issuers\u2019 element). It is in the interest of the consumer that for the same category of cards the payees cannot discriminate between issuers or cardholders, and payment card schemes and payment service providers can impose such an obligation on them. Therefore the \u2018Honour all Issuers\u2019 element of the \u2018Honour all Cards\u2019 rule is a justifiable rule within a payment card scheme, since it prevents payees from discriminating between individual banks which have issued a card. The \u2018Honour all Products\u2019 element is essentially a tying practice that has the effect of tying acceptance of low fee cards to the acceptance of high fee cards. A removal of the \u2018Honour all Products\u2019 element of the \u2018Honour all Cards\u2019 rule would allow merchants to limit the choice of payment cards they offer to low(er) cost payment cards only, which would also benefit consumers through reduced merchants' costs. Merchants accepting debit cards would then not be forced to accept credit cards, and those accepting credit cards would not be forced to accept commercial cards. However, to protect the consumer and the consumer's ability to use the payment cards as often as possible, merchants should be obliged to accept cards that are subject to the same regulated interchange fee only if issued within the same brand and of the same category (prepaid card, debit card or credit card). Such a limitation would also result in a more competitive environment for cards with interchange fees not regulated under this Regulation, as merchants would gain more negotiating power as regards the conditions under which they accept such cards. Those restrictions should be limited and considered acceptable only to enhance consumers' protection, giving to the consumers an adequate level of certainty about the fact that their payment cards will be accepted by the merchants. (38) A clear distinction between consumer and commercial cards should be ensured by the payment service providers both on a technical and on a commercial basis. It is therefore important to define a commercial card as a payment instrument used only for business expenses charged directly to the account of the undertaking or public sector entity or the self-employed natural person. (39) Payees and payers should have the means to identify the different categories of cards. Therefore, the various brands and categories should be identifiable electronically and for newly issued card-based payment instruments visibly on the device. In addition, the payer should be informed about the acceptance of the payer's payment instrument(s) at a given point of sale. It is necessary that any limitation on the use of a given brand be announced by the payee to the payer at the same time and under the same conditions as the information that a given brand is accepted. (40) In order to ensure that competition between brands is effective, it is important that the choice of payment application be made by users, not imposed by the upstream market, comprising payment card schemes, payment service providers or processors. Such an arrangement should not prevent payers and payees from setting a default choice of application, where technically feasible, provided that that choice can be changed for each transaction. (41) In order to ensure that redress is possible where this Regulation has been incorrectly applied, or where disputes occur between payment services users and payment service providers, Member States should establish adequate and effective out-of-court complaint and redress procedures or take equivalent measures. Member States should lay down rules on the penalties applicable to infringements of this Regulation and should ensure that those penalties are effective, proportionate and dissuasive and that they are applied. (42) The Commission should present a report studying various effects of this Regulation on the functioning of the market. It is necessary that the Commission has the possibility to collect the information required to establish this report and that the competent authorities cooperate closely with the Commission for the collection of data. (43) Since the objectives of this Regulation to lay down uniform requirements for card-based payment transactions and internet and mobile payments based on cards cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (44) This Regulation complies with the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, notably the right to an effective remedy or to a fair trial, the freedom to conduct a business, consumer protection and has to be applied in accordance with those rights and principles, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Scope 1. This Regulation lays down uniform technical and business requirements for card-based payment transactions carried out within the Union, where both the payer's payment service provider and the payee's payment service provider are located therein. 2. This Regulation does not apply to services based on specific payment instruments that can be used only in a limited way, that meet one of the following conditions: (a) instruments allowing the holder to acquire goods or services only in the premises of the issuer or within a limited network of service providers under direct commercial agreement with a professional issuer; (b) instruments which can be used only to acquire a very limited range of goods or services; (c) instruments valid only in a single Member State provided at the request of an undertaking or a public sector entity and regulated by a national or regional public authority for specific social or tax purposes to acquire specific goods or services from suppliers having a commercial agreement with the issuer. 3. Chapter II does not apply to the following: (a) transactions with commercial cards; (b) cash withdrawals at automatic teller machines or at the counter of a payment service provider; and (c) transactions with payment cards issued by three party payment card schemes. 4. Article 7 does not apply to three party payment card schemes. 5. When a three party payment card scheme licenses other payment service providers for the issuance of card-based payment instruments or the acquiring of card-based payment transactions, or both, or issues card-based payment instruments with a co-branding partner or through an agent, it is considered to be a four party payment card scheme. However, until 9 December 2018 in relation to domestic payment transactions, such a three party payment card scheme may be exempted from the obligations under Chapter II, provided that the card-based payment transactions made in a Member State under such a three party payment card scheme do not exceed on a yearly basis 3 % of the value of all card-based payment transactions made in that Member State. Article 2 Definitions For the purposes of this Regulation, the following definitions shall apply: (1) \u2018acquirer\u2019 means a payment service provider contracting with a payee to accept and process card-based payment transactions, which result in a transfer of funds to the payee; (2) \u2018issuer\u2019 means a payment service provider contracting to provide a payer with a payment instrument to initiate and process the payer's card-based payment transactions; (3) \u2018consumer\u2019 means a natural person who, in payment service contracts covered by this Regulation, is acting for purposes other than the trade, business or profession of that person; (4) \u2018debit card transaction\u2019 means a card-based payment transaction, including those with prepaid cards that is not a credit card transaction; (5) \u2018credit card transaction\u2019 means a card-based payment transaction where the amount of the transaction is debited in full or in part at a pre agreed specific calendar month date to the payer, in line with a prearranged credit facility, with or without interest; (6) \u2018commercial card\u2019 means any card-based payment instrument issued to undertakings or public sector entities or self-employed natural persons which is limited in use for business expenses where the payments made with such cards are charged directly to the account of the undertaking or public sector entity or self-employed natural person; (7) \u2018card-based payment transaction\u2019 means a service based on a payment card scheme's infrastructure and business rules to make a payment transaction by means of any card, telecommunication, digital or IT device or software if this results in a debit or a credit card transaction. Card-based payment transactions exclude transactions based on other kinds of payment services; (8) \u2018cross-border payment transaction\u2019 means a card-based payment transaction where the issuer and the acquirer are located in different Member States or where the card-based payment instrument is issued by an issuer located in a Member State different from that of the point of sale; (9) \u2018domestic payment transaction\u2019 means any card-based payment transaction which is not a cross-border payment transaction; (10) \u2018interchange fee\u2019 means a fee paid for each transaction directly or indirectly (i.e. through a third party) between the issuer and the acquirer involved in a card-based payment transaction. The net compensation or other agreed remuneration is considered to be part of the interchange fee; (11) \u2018net compensation\u2019 means the total net amount of payments, rebates or incentives received by an issuer from the payment card scheme, the acquirer or any other intermediary in relation to card-based payment transactions or related activities; (12) \u2018merchant service charge\u2019 means a fee paid by the payee to the acquirer in relation to card-based payment transactions; (13) \u2018payee\u2019 means a natural or legal person who is the intended recipient of funds which have been the subject of a payment transaction; (14) \u2018payer\u2019 means a natural or legal person who holds a payment account and allows a payment order from that payment account, or, where there is no payment account, a natural or legal person who gives a payment order; (15) \u2018payment card\u2019 means a category of payment instrument that enables the payer to initiate a debit or credit card transaction; (16) \u2018payment card scheme\u2019 means a single set of rules, practices, standards and/or implementation guidelines for the execution of card-based payment transactions and which is separated from any infrastructure or payment system that supports its operation, and includes any specific decision-making body, organisation or entity accountable for the functioning of the scheme; (17) \u2018four party payment card scheme\u2019 means a payment card scheme in which card-based payment transactions are made from the payment account of a payer to the payment account of a payee through the intermediation of the scheme, an issuer (on the payer's side) and an acquirer (on the payee's side); (18) \u2018three party payment card scheme\u2019 means a payment card scheme in which the scheme itself provides acquiring and issuing services and card-based payment transactions are made from the payment account of a payer to the payment account of a payee within the scheme. When a three party payment card scheme licenses other payment service providers for the issuance of card-based payment instruments or the acquiring of card-based payment transactions, or both, or issues card-based payment instruments with a co-branding partner or through an agent, it is considered to be a four party payment card scheme; (19) \u2018payment instrument\u2019 means any personalised device(s) and/or set of procedures agreed between the payment service user and the payment service provider and used in order to initiate a payment order; (20) \u2018card-based payment instrument\u2019 means any payment instrument, including a card, mobile phone, computer or any other technological device containing the appropriate payment application which enables the payer to initiate a card-based payment transaction which is not a credit transfer or a direct debit as defined by Article 2 of Regulation (EU) No 260/2012; (21) \u2018payment application\u2019 means computer software or equivalent loaded on a device enabling card-based payment transactions to be initiated and allowing the payer to issue payment orders; (22) \u2018payment account\u2019 means an account held in the name of one or more payment service users which is used for the execution of payment transactions, including through a specific account for electronic money as defined in point 2 of Article 2 of Directive 2009/110/EC of the European Parliament and of the Council (8); (23) \u2018payment order\u2019 means any instruction by a payer to its payment service provider requesting the execution of a payment transaction; (24) \u2018payment service provider\u2019 means any natural or legal person authorised to provide the payment services listed in the Annex to Directive 2007/64/EC or recognised as an electronic money issuer in accordance with Article 1(1) of Directive 2009/110/EC. A payment service provider can be an issuer or an acquirer or both; (25) \u2018payment service user\u2019 means a natural or legal person making use of a payment service in the capacity of either payer or payee, or both; (26) \u2018payment transaction\u2019 means an action, initiated by the payer or on its behalf or by the payee of transferring funds, irrespective of any underlying obligations between the payer and the payee; (27) \u2018processing\u2019 means the performance of payment transaction processing services in terms of the actions required for the handling of a payment instruction between the acquirer and the issuer; (28) \u2018processing entity\u2019 means any natural or legal person providing payment transaction processing services; (29) \u2018point of sale\u2019 means the address of the physical premises of the merchant at which the payment transaction is initiated. However: (a) in the case of distance sales or distance contracts (i.e. e-commerce) as defined in point 7 of Article 2 of Directive 2011/83/EU, the point of sale shall be the address of the fixed place of business at which the merchant conducts its business regardless of website or server locations through which the payment transaction is initiated; (b) in the event that the merchant does not have a fixed place of business, the point of sale shall be the address for which the merchant holds a valid business licence through which the payment transaction is initiated; (c) in the event that the merchant does not have a fixed place of business nor a valid business licence, the point of sale shall be the address for correspondence for the payment of its taxes relating to its sales activity through which the payment transaction is initiated; (30) \u2018payment brand\u2019 means any material or digital name, term, sign, symbol or combination thereof, capable of denoting under which payment card scheme card-based payment transactions are carried out; (31) \u2018co-badging\u2019 means the inclusion of two or more payment brands or payment applications of the same brand on the same card-based payment instrument; (32) \u2018co-branding\u2019 means the inclusion of at least one payment brand and at least one non-payment brand on the same card-based payment instrument; (33) \u2018debit card\u2019 means a category of payment instrument that enables the payer to initiate a debit card transaction excluding those with prepaid cards; (34) \u2018credit card\u2019 means a category of payment instrument that enables the payer to initiate a credit card transaction; (35) \u2018prepaid card\u2019 means a category of payment instrument on which electronic money, as defined in point 2 of Article 2 of Directive 2009/110/EC, is stored. CHAPTER II INTERCHANGE FEES Article 3 Interchange fees for consumer debit card transactions 1. Payment service providers shall not offer or request a per transaction interchange fee of more than 0,2 % of the value of the transaction for any debit card transaction. 2. For domestic debit card transactions Member States may either: (a) define a per transaction percentage interchange fee cap lower than the one provided for in paragraph 1 and may impose a fixed maximum fee amount as a limit on the fee amount resulting from the applicable percentage rate; or (b) allow payment service providers to apply a per transaction interchange fee of no more than EUR 0,05, or, in the Member States whose currency is not the euro, the corresponding value in the national currency on 8 June 2015, which shall be revised every five years or whenever there is a significant variation in exchange rates. This per transaction interchange fee may also be combined with a maximum percentage rate of no more than 0,2 %, provided always that the sum of interchange fees of the payment card scheme does not exceed 0,2 % of the total annual transaction value of the domestic debit card transactions within each payment card scheme. 3. Until 9 December 2020, in relation to domestic debit card transactions, Member States may allow payment service providers to apply a weighted average interchange fee of no more than the equivalent of 0,2 % of the annual average transaction value of all domestic debit card transactions within each payment card scheme. Member States may define a lower weighted average interchange fee cap applicable to all domestic debit card transactions. 4. The annual transaction values referred to in paragraphs 2 and 3 shall be calculated on a yearly basis, commencing on 1 January and ending on 31 December and shall be applied starting from 1 April of the following year. The reference period for the first calculation of such value shall commence 15 calendar months before the date of application of paragraphs 2 and 3 and shall end three calendar months before that date. 5. The competent authorities referred to in Article 13 shall, upon their written request, require payment card schemes and/or payment service providers to provide all information necessary to verify the correct application of paragraphs 3 and 4 of this Article. Such information shall be sent to the competent authority before 1 March of the year following the reference period referred to in the first sentence of paragraph 4. Any other information enabling the competent authorities to verify compliance with the provisions of this Chapter shall be sent to the competent authorities upon their written request and within the deadline set by them. The competent authorities may require that such information is certified by an independent auditor. Article 4 Interchange fees for consumer credit card transactions Payment service providers shall not offer or request a per transaction interchange fee of more than 0,3 % of the value of the transaction for any credit card transaction. For domestic credit card transactions Member States may define a lower per transaction interchange fee cap. Article 5 Prohibition of circumvention For the purposes of the application of the caps referred to in Articles 3 and 4, any agreed remuneration, including net compensation, with an equivalent object or effect of the interchange fee, received by an issuer from the payment card scheme, acquirer or any other intermediary in relation to payment transactions or related activities shall be treated as part of the interchange fee. CHAPTER III BUSINESS RULES Article 6 Licensing 1. Any territorial restrictions within the Union or rules with an equivalent effect in licensing agreements or in payment card scheme rules for issuing payment cards or acquiring card-based payment transactions shall be prohibited. 2. Any requirement or obligation to obtain a country specific licence or authorisation to operate on a cross-border basis or rule with an equivalent effect in licensing agreements or in payment card scheme rules for issuing payment cards or acquiring card-based payment transactions shall be prohibited. Article 7 Separation of payment card scheme and processing entities 1. Payment card schemes and processing entities: (a) shall be independent in terms of accounting, organisation and decision-making processes; (b) shall not present prices for payment card scheme and processing activities in a bundled manner and shall not cross-subsidise such activities; (c) shall not discriminate in any way between their subsidiaries or shareholders on the one hand and users of payment card schemes and other contractual partners on the other hand and shall not in particular make the provision of any service they offer conditional in any way on the acceptance by their contractual partner of any other service they offer. 2. The competent authority of the Member State where the registered office of the scheme is located may require a payment card scheme to provide an independent report confirming its compliance with paragraph 1. 3. Payment card schemes shall allow for the possibility that authorisation and clearing messages of single card-based payment transactions be separated and processed by different processing entities. 4. Any territorial discrimination in processing rules operated by payment card schemes shall be prohibited. 5. Processing entities within the Union shall ensure that their system is technically interoperable with other systems of processing entities within the Union through the use of standards developed by international or European standardisation bodies. In addition, payment card schemes shall not adopt or apply business rules that restrict interoperability among processing entities within the Union. 6. The European Banking Authority (EBA) may, after consulting an advisory panel as referred to in Article 41 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (9), develop draft regulatory technical standards establishing the requirements to be complied with by payment card schemes and processing entities to ensure the application of point (a) of paragraph 1 of this Article. EBA shall submit those draft regulatory technical standards to the Commission by 9 December 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. Article 8 Co-badging and choice of payment brand or payment application 1. Any payment card scheme rules and rules in licensing agreements or measures of equivalent effect that hinder or prevent an issuer from co-badging two or more different payment brands or payment applications on a card-based payment instrument shall be prohibited. 2. When entering into a contractual agreement with a payment service provider, the consumer may require two or more different payment brands on a card-based payment instrument provided that such a service is offered by the payment service provider. In good time before the contract is signed, the payment service provider shall provide the consumer with clear and objective information on all the payment brands available and their characteristics, including their functionality, cost and security. 3. Any difference in treatment of issuers or acquirers in scheme rules and rules in licensing agreements concerning co-badging of different payment brands or payment applications on a card-based payment instrument shall be objectively justified and non-discriminatory. 4. Payment card schemes shall not impose reporting requirements, obligations to pay fees or similar obligations with the same object or effect on card issuing and acquiring payment service providers for transactions carried out with any device on which their payment brand is present in relation to transactions for which their scheme is not used. 5. Any routing principles or equivalent measures aimed at directing transactions through a specific channel or process and other technical and security standards and requirements with respect to the handling of two or more different payment brands and payment applications on a card-based payment instrument shall be non-discriminatory and shall be applied in a non-discriminatory manner. 6. Payment card schemes, issuers, acquirers, processing entities and other technical service providers shall not insert automatic mechanisms, software or devices on the payment instrument or at equipment applied at the point of sale which limit the choice of payment brand or payment application, or both, by the payer or the payee when using a co-badged payment instrument. Payees shall retain the option of installing automatic mechanisms in the equipment used at the point of sale which make a priority selection of a particular payment brand or payment application but payees shall not prevent the payer from overriding such an automatic priority selection made by the payee in its equipment for the categories of cards or related payment instruments accepted by the payee. Article 9 Unblending 1. Each acquirer shall offer and charge its payee merchant service charges individually specified for different categories and different brands of payment cards with different interchange fee levels unless payees request the acquirer, in writing, to charge blended merchant service charges. 2. Acquirers shall include in their agreements with payees individually specified information on the amount of the merchant service charges, interchange fees and scheme fees applicable with respect to each category and brand of payment cards, unless the payee subsequently makes a different request in writing. Article 10 \u2018Honour All Cards\u2019 rule 1. Payment card schemes and payment service providers shall not apply any rule that obliges payees accepting a card-based payment instrument issued by one issuer also to accept other card-based payment instruments issued within the framework of the same payment card scheme. 2. Paragraph 1 shall not apply to consumer card-based payment instruments of the same brand and of the same category of prepaid card, debit card or credit card subject to interchange fees under Chapter II of this Regulation. 3. Paragraph 1 is without prejudice to the possibility for payment card schemes and payment service providers to provide that cards may not be refused on the basis of the identity of the issuer or of the cardholder. 4. Payees that decide not to accept all cards or other payment instruments of a payment card scheme shall inform consumers of this, in a clear and unequivocal manner, at the same time as they inform consumers of the acceptance of other cards and payment instruments of the payment card scheme. Such information shall be displayed prominently at the entrance of the shop and at the till. In the case of distance sales, this information shall be displayed on the payee's website or other applicable electronic or mobile medium. The information shall be provided to the payer in good time before the payer enters into a purchase agreement with the payee. 5. Issuers shall ensure that their payment instruments are electronically identifiable and, in the case of newly issued card-based payment instruments, also visibly identifiable, enabling payees and payers to unequivocally identify which brands and categories of prepaid cards, debit cards, credit cards or commercial cards are chosen by the payer. Article 11 Steering rules 1. Any rule in licensing agreements, in scheme rules applied by payment card schemes and in agreements entered into between card acquirers and payees preventing payees from steering consumers to the use of any payment instrument preferred by the payee shall be prohibited. This prohibition shall also cover any rule prohibiting payees from treating card-based payment instruments of a given payment card scheme more or less favourably than others. 2. Any rule in licensing agreements, in scheme rules applied by payment card schemes and in agreements entered into between card acquirers and payees preventing payees from informing payers about interchange fees and merchant service charges shall be prohibited. 3. Paragraphs 1 and 2 of this Article are without prejudice to the rules on charges, reductions or other steering mechanisms set out in Directive 2007/64/EC and Directive 2011/83/EU. Article 12 Information to the payee on individual card-based payment transactions 1. After the execution of an individual card-based payment transaction, the payee's payment service provider shall provide the payee with the following information: (a) the reference enabling the payee to identify the card-based payment transaction; (b) the amount of the payment transaction in the currency in which the payee's payment account is credited; (c) the amount of any charges for the card-based payment transaction, indicating separately the merchant service charge and the amount of the interchange fee. With the payee's prior and explicit consent, the information referred to in the first subparagraph may be aggregated by brand, application, payment instrument categories and rates of interchange fees applicable to the transaction. 2. Contracts between acquirers and payees may include a provision that the information referred to in the first subparagraph of paragraph 1 shall be provided or made available periodically, at least once a month, and in an agreed manner which allows payees to store and reproduce information unchanged. CHAPTER IV FINAL PROVISIONS Article 13 Competent authorities 1. Member States shall designate competent authorities that are empowered to ensure enforcement of this Regulation and that are granted investigation and enforcement powers. 2. Member States may designate existing bodies to act as competent authorities. 3. Member States may designate one or more competent authorities. 4. Member States shall notify the Commission of those competent authorities by 9 June 2016. They shall notify the Commission without delay of any subsequent change concerning those authorities. 5. The designated competent authorities referred to in paragraph 1 shall have adequate resources for the performance of their duties. 6. Member States shall require the competent authorities to monitor effectively compliance with this Regulation, including to counter attempts by the payment service providers to circumvent this Regulation, and take all necessary measures to ensure such compliance. Article 14 Penalties 1. Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are applied. 2. Member States shall notify those provisions to the Commission by 9 June 2016 and shall notify without delay of any subsequent amendment affecting them. Article 15 Settlement, out of court complaints and redress procedures 1. Member States shall ensure and promote adequate and effective out-of-court complaint and redress procedures or take equivalent measures for the settlement of disputes arising under this Regulation between payees and their payment service providers. For those purposes, Member States shall designate existing bodies, where appropriate, or establish new bodies. The bodies shall be independent from the parties. 2. Member States shall notify the Commission of those bodies by 9 June 2017. They shall notify the Commission without delay of any subsequent change concerning those bodies. Article 16 Universal cards 1. For the purposes of this Regulation, in relation to domestic payment transactions that are not distinguishable as debit or credit card transactions by the payment card scheme, the provisions on debit cards or debit card transactions are applied. 2. By derogation from paragraph 1, until 9 December 2016, Member States may define a share of no more than 30 % of the domestic payment transactions referred to in paragraph 1 of this Article that are considered to be equivalent to credit card transactions to which the interchange fee cap set in Article 4 shall apply. Article 17 Review clause By 9 June 2019, the Commission shall submit a report on the application of this Regulation to the European Parliament and to the Council. The Commission's report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges, taking into account the use and cost of the various means of payments and the level of entry of new players, new technology and innovative business models on the market. The assessment shall, in particular, consider: (a) the development of fees for payers; (b) the level of competition among payment card providers and payment card schemes; (c) the effects on costs for the payer and the payee; (d) the levels of merchant pass-through of the reduction in interchange fee levels; (e) the technical requirements and their implications for all the parties involved; (f) the effects of co-badging on user-friendliness, in particular for the elderly and other vulnerable users; (g) the effect on the market of the exclusion of commercial cards from Chapter II, comparing the situation in those Member States where surcharging is prohibited with those where it is permitted; (h) the effect on the market of the special provisions for interchange fees for domestic debit card transactions; (i) the development of cross-border acquiring and its effect on the single market, comparing the situation for cards with capped fees and cards which are not capped, to consider the possibility of clarifying which interchange fee applies to cross-border acquiring; (j) the application in practice of the rules on separation of payment card scheme and processing, and the need to reconsider legal unbundling; (k) the possible need, depending on the effect of Article 3(1) on the actual value of interchange fees for medium and high value debit card transactions, to revise that paragraph by providing that the cap should be limited to the lower amount of EUR 0,07 or 0,2 % of the value of the transaction. The report by the Commission shall, if appropriate, be accompanied by a legislative proposal that may include a proposed amendment of the maximum cap for interchange fees. Article 18 Entry into force 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 8 June 2015, with the exception of Articles 3, 4, 6 and 12, which shall apply from 9 December 2015, and of Articles 7, 8, 9 and 10, which shall apply from 9 June 2016 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 29 April 2015. For the European Parliament The President M. SCHULZ For the Council The President Z. KALNI\u0145A-LUKA\u0160EVICA (1) OJ C 193, 24.6.2014, p. 2. (2) OJ C 170, 5.6.2014, p. 78. (3) Position of the European Parliament of 10 March 2015 (not yet published in the Official Journal) and Decision of the Council of 20 April 2015. (4) Directive 2007/64/EC of the European Parliament and of the Council of 13 November 2007 on payment services in the internal market amending Directives 97/7/EC, 2002/65/EC, 2005/60/EC and 2006/48/EC and repealing Directive 97/5/EC (OJ L 319, 5.12.2007, p. 1). (5) Regulation (EC) No 924/2009 of the European Parliament and of the Council of 16 September 2009 on cross-border payments in the Community and repealing Regulation (EC) No 2560/2001 (OJ L 266, 9.10.2009, p. 11). (6) Regulation (EU) No 260/2012 of the European Parliament and of the Council of 14 March 2012 establishing technical and business requirements for credit transfers and direct debits in euro and amending Regulation (EC) No 924/2009 (OJ L 94, 30.3.2012, p. 22). (7) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (8) Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (OJ L 267, 10.10.2009, p. 7). (9) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).", "summary": "Fees for card-based payments Fees for card-based payments SUMMARY OF: Regulation (EU) 2015/751 on interchange fees for card-based payment transactions WHAT IS THE AIM OF THE REGULATION? This regulation caps interchange fees. It increases transparency on fees thus permitting retailers to know the level of fees paid when accepting cards. It enhances competition by providing consumers with more and better choices between different types of payment cards and service providers. KEY POINTS Specifically, the regulation: caps interchange fees at 0.2% of the transaction value for consumer debit cards and at 0.3% for consumer credit cards; as regards consumer credit cards, allows EU countries to define percentage caps lower than 0.3%; as regards consumer debit card transactions, allows EU countries to impose a fee of no more than 5 eurocents per transaction interchange fee in combination with the 0.2% cap; provides for a limited number of exemptions, such as business cards used only for business expenses being charged directly to the account of the company; increases transparency on the level of fees paid by retailers, thus enabling them more easily to select which payment cards to accept. The regulation is part of a package that includes also the revised Payment Services Directive (PSD2), on which political agreement was reached in May 2015. The package aims to promote the digital single market by making payments safer and cheaper and paves the way for innovative payment technologies. FROM WHEN DOES THE REGULATION APPLY? It has applied since 8 June 2015. BACKGROUND For more information, see: Card, internet and mobile payments (European Commission) Payment services (European Commission). MAIN DOCUMENT Regulation (EU) 2015/751 of the European Parliament and of the Council of 29 April 2015 on interchange fees for card-based payment transactions (OJ L 123, 19.5.2015, pp. 1-15) RELATED DOCUMENTS Commission Delegated Regulation (EU) 2018/72 of 4 October 2017 supplementing Regulation (EU) 2015/751 of the European Parliament and of the Council on interchange fees for card-based payment transactions with regard to regulatory technical standards establishing the requirements to be complied with by payment card schemes and processing entities to ensure the application of independence requirements in terms of accounting, organisation and decision-making process (OJ L 13, 18.1.2018, pp. 1-7) Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35-127) last update 30.08.2018"}
{"article": "2.5.2018 EN Official Journal of the European Union L 112/42 DECISION (EU) 2018/646 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 April 2018 on a common framework for the provision of better services for skills and qualifications (Europass) and repealing Decision No 2241/2004/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 165 and 166 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Individuals, when looking for a job, or making decisions on learning, studying or working, need access to information and guidance on what opportunities are available, on how to assess their skills and on ways to present information about their skills and qualifications. (2) Differences in definitions, document formats, languages as well as assessment and validation methods all pose considerable challenges for individuals, employers, competent authorities and bodies. Those challenges arise mainly when individuals move between countries, including third countries, but also when they are looking for a new job or engaging in learning and career management. Clear and widely disseminated information, a shared understanding and improved transparency of skills and qualifications are important in order to address those challenges. (3) The New Skills Agenda for Europe, adopted by the Commission on 10 June 2016, invites Member States, social partners, industry and other stakeholders to work together on ten actions to improve the quality and relevance of skills formation, to make skills more visible and comparable and to improve skills intelligence and especially information for better career choices. A revision of the Europass framework was proposed as one of the ten actions that offer a key route to achieving and supporting those objectives. (4) Decision No 2241/2004/EC of the European Parliament and of the Council (3) established a framework to address the challenges relating to job seeking, engaging in learning and career management. The aim of that Decision was to achieve better transparency of qualifications and competences through a portfolio of documents known as \u2018Europass\u2019, which individuals can use on a voluntary basis. That Decision also established national bodies, known as National Europass Centres, in order to implement the Europass framework. (5) To achieve its main objective, the Europass framework focuses on tools for the documentation of skills and qualifications. Those tools have become widely used through the Europass internet-based information system. (6) The National Europass Centres provide support to users and promote the documentation of skills and qualifications. The Euroguidance Network, which promotes the European dimension in guidance and provides high quality information on lifelong guidance and transnational mobility for learning purposes, has also contributed to the development of information provision regarding Union tools for skills and qualifications. The European Qualifications Framework National Coordination Points support national authorities in referencing national qualifications frameworks or systems to the European Qualifications Framework (\u2018EQF\u2019) and focus on bringing the EQF closer to individuals and organisations. Support for, and greater coordination of, those national services should be ensured in order to enhance their impact while respecting the diversity of national systems. (7) In its report to the European Parliament and the Council of 19 December 2013 on the evaluation of Europass, the Commission concluded that the National Europass Centres' mission of raising awareness of Europass and providing the necessary information to interested parties was a satisfactory model for the implementation of Europass. The Commission further concluded, however, that most Europass tools still did not reach all potential users and had an unequal reach in terms of geography and age group, and that better coordination and integration of services supporting guidance and mobility within the Europass framework would enable more potential users to be targeted. (8) Evidence shows that Europass is used by social groups with high digital literacy while less advantaged groups, such as people with lower levels of education, older persons or long-term unemployed persons are often not aware of the existence of Europass and its tools and therefore cannot benefit from it. (9) The Europass portfolio is one of a number of tools and instruments that have been put in place at Union level to improve transparency and understanding of skills and qualifications. (10) The Europass portfolio comprises five document templates. The Europass Curriculum Vitae (CV) template allows individuals to complete their CVs in a standardised format. Since the Europass CV was first established in 2004, more than 100 million Europass CVs have been created online. Two qualification supplement templates, namely the Europass Diploma Supplement and the Europass Certificate Supplement, offer information on the content and learning outcomes associated with a qualification and on the education system of the country issuing the qualification. The Europass Language Passport is used to describe language skills. The Europass Mobility template describes the skills acquired abroad on mobility experiences for learning or work. (11) The Council Recommendation of 22 May 2017 (4) provides a common reference framework to help individuals and organisations compare different qualification systems and the levels of qualifications from those systems. (12) The Council Recommendation of 20 December 2012 (5) invited Member States to have in place, by 2018, in accordance with national circumstances and specificities, and as they deem appropriate, arrangements for the validation of non-formal and informal learning, which enable individuals to have their knowledge, skills and competences, which have been acquired through non-formal and informal learning, validated, and to obtain a full qualification, or, where applicable, partial qualification. (13) The Council Resolution of 28 May 2004 on strengthening policies, systems and practices in the field of guidance throughout life sets out the key objectives of a lifelong guidance policy for all citizens of the Union. The Council Resolution of 21 November 2008 (6) highlights the importance of guidance for lifelong learning. (14) The Learning Opportunities and Qualifications in Europe portal gives access to information on learning opportunities and qualifications offered in different education systems in Europe and on the comparison of national qualifications frameworks using the EQF. (15) The EU Skills Panorama provides information on skills for different occupations and specific industries, including demand and supply at national level. (16) The analysis of job vacancies and of other labour market trends is an established way of developing skills intelligence to understand the issues of skills gaps and shortages as well as qualification mismatches. (17) The multilingual European Skills, Competences, Qualifications and Occupations classification (\u2018ESCO\u2019), developed and continuously updated by the Commission, in close cooperation with Member States and stakeholders, aims to promote the transparency of skills and qualifications for education and training, as well as for work-related purposes. Following appropriate testing, and having due regard for the position of Member States, ESCO could be used by the Commission within the Europass framework; the use of ESCO by Member States is on a voluntary basis, following testing with, and evaluation by, the Member States. (18) The European network of employment services (\u2018EURES\u2019), established by Regulation (EU) 2016/589 of the European Parliament and of the Council (7), is a cooperative network for exchanging information and facilitating interaction between jobseekers and employers. It provides free assistance to jobseekers who wish to move to another country and assists employers who wish to recruit workers from other countries. Synergies and cooperation between the Europass and EURES portals could reinforce the impact of both services. (19) Labour market processes such as the publication of job vacancies, job applications, skills assessments and recruitment are increasingly managed online through tools that use social media, big data and other technologies. Candidate selection is managed through tools and processes that seek information on skills and qualifications acquired in formal, non-formal and informal settings. (20) Formal, non-formal and informal learning currently also takes place in new forms and settings, and is offered by a variety of providers, particularly through the use of digital technologies and platforms, distance learning, e-learning, peer-to-peer learning, massive open online courses and open educational resources. Furthermore, skills, experiences and learning achievements are acknowledged in different forms, for example digital open badges. Digital technologies are also used for skills obtained through non-formal learning such as youth work and volunteering. (21) For the purposes of this Decision, skills are understood in a broad sense covering what a person knows, understands and can do. Skills refer to different types of learning outcomes, including knowledge and competences as well as ability to apply knowledge and to use knowhow in order to complete tasks and solve problems. In addition to the acknowledged importance of professional skills, there is an acknowledgement that transversal or soft skills, such as critical thinking, team work, problem solving and creativity, digital or language skills, are increasingly important and are essential prerequisites for personal and professional fulfilment and can be applied in different fields. Individuals could benefit from tools and guidance on assessing and describing those and other skills. (22) Traditionally, individuals have presented information on their acquired skills and qualifications in a CV and in supporting documents such as certificates or diplomas. Now, new tools are available which can facilitate the presentation of skills and qualifications by using varied online and digital formats. The new tools can also support self-assessment by individuals of skills acquired in different settings. (23) The Europass framework should respond to current and future needs. Users need tools to document their skills and qualifications. In addition, tools for assessment of skills and self-assessment of skills, as well as access to relevant information, including information on validation opportunities and guidance, can be beneficial for making decisions on employment and learning opportunities. (24) Union tools for skills and qualifications should adapt to changing practices and advances in technology in order to ensure they remain relevant and beneficial to users. This should be achieved by, among other things, creating innovative features, such as interactive tools, editing and design of documents, by seeking to ensure more comprehensive, effective and efficient tools and simplification, as well as increased technical interoperability and synergies between related tools, including those developed by third parties, and by taking into account the specific needs of people with disabilities. In addition, authentication measures could be used to support the verification of digital documents on skills and qualifications. (25) The Europass framework established by Decision No 2241/2004/EC should therefore be replaced by a new framework to address evolving needs. (26) The new Europass framework should meet the needs and expectations of all individual end-users, such as learners, job seekers, including unemployed persons and workers, as well as of other relevant stakeholders, such as employers (in particular small and medium-sized enterprises), chambers of commerce, civil society organisations, volunteers, guidance practitioners, public employment services, social partners, education and training providers, youth organisations, youth work providers, responsible national authorities and policy makers. It should also consider the needs of third country nationals arriving or residing in the Union to support their integration. (27) The Europass framework should evolve in order to allow for the description of different types of learning and skills and, in particular, those acquired through non-formal and informal learning. (28) The Europass framework should be developed through a user-centric approach based on feedback, and through requirements gathering, including through surveys and testing, with attention paid to the particular current and future needs of Europass target groups. Europass' features should in particular reflect the Member States' and the Union's commitment to ensure that persons with disabilities have equal access to the labour market and to information and communication technologies and systems. Europass tools should be perceivable, operable, understandable and robust, thereby enabling them to be more accessible to users, in particular to persons with disabilities. (29) Updates and changes to the Europass framework should be made in cooperation with relevant stakeholders, such as employment services, guidance practitioners, education and training providers, the social partners such as trade unions and employers' associations, and in full respect of ongoing political cooperation, such as the Bologna Process in the European Higher Education Area. Constructive collaboration between the Commission, Member States and stakeholders is of paramount importance to the successful development and implementation of the Europass framework. (30) Relevant Union law on personal data protection and national implementing measures should apply to the processing of personal data that are stored and processed pursuant to this Decision. Users should have the possibility to restrict access to their personal data. (31) Participation in the framework should be open to members of the European Economic Area which are not Member States of the Union, acceding States, candidate States and potential candidate States for accession to the Union, given their long-standing interest and cooperation with the Union in this field. Participation should be in accordance with the relevant provisions of the instruments governing relations between the Union and those countries. Information on skills and qualifications provided through the Europass framework should come from a wider range of countries and education systems than those of participating countries and reflect migration movements from and to other parts of the world. (32) The Commission should ensure the coherent implementation and monitoring of this Decision through a Europass advisory group composed of representatives of the Member States and relevant stakeholders. The advisory group should, in particular, develop a strategic approach to the implementation and future development of Europass, and advise on the development of web-based tools, including through testing, and on information provided through the Europass online platform, in cooperation with other groups, where relevant. (33) Co-funding for the implementation of this Decision is provided, inter alia, by the Union programme Erasmus+, as established by Regulation (EU) No 1288/2013 of the European Parliament and of the Council (8). The committee created under that Regulation is involved in strategic discussions on the progress of Europass implementation, and on future developments. (34) Since the objective of this Decision, namely the establishment of a comprehensive and interoperable framework of tools and information, in particular for transnational employment and learning mobility purposes, cannot be sufficiently achieved by the Member States but can rather, by reason of the effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Decision does not go beyond what is necessary in order to achieve that objective. (35) As a general principle, the obligations and administrative and financial burdens on the Member States should be balanced with regard to costs and benefits. (36) The activities carried out in the context of this Decision should be supported by the expertise of the Union agencies, in particular by the European Centre for the Development of Vocational Training, within their domains of competence. (37) Decision No 2241/2004/EC should therefore be repealed, without prejudice to the validity or status of previously issued Europass documents. All established Europass document templates should be maintained within the new framework until such time as necessary changes or updates are made in accordance with this Decision. In order to ensure a smooth transition to the Europass online platform, the Europass internet-based information system established by Decision No 2241/2004/EC should continue to operate until the Europass online platform is set up and becomes operational, HAVE ADOPTED THIS DECISION: Article 1 Subject matter and scope 1. This Decision establishes a European framework to support the transparency and understanding of skills and qualifications acquired in formal, non-formal and informal settings, including through practical experiences, mobility and volunteering (\u2018Europass\u2019). 2. Europass shall consist of web-based tools and relevant available information, including information to support the European dimension of guidance provided through an online platform and supported by national services intended to help users to better communicate and present skills and qualifications and to compare qualifications. 3. Europass shall be targeted at: (a) individual end-users, such as learners, job seekers, workers and volunteers, and (b) relevant stakeholders, such as education and training providers, guidance practitioners, employers, public employment services, social partners, youth work providers, youth organisations and policy makers. 4. The use of Europass shall be voluntary and shall not impose any obligations or confer any rights other than those defined in this Decision. Article 2 Definitions For the purposes of this Decision, the following definitions apply: (a) \u2018certificate supplement\u2019 means a document attached to a vocational education and training or professional certificate issued by the competent authorities or bodies, in order to make it easier for third persons \u2013 particularly in another country \u2013 to understand the learning outcomes acquired by the holder of the qualification, as well as the nature, level, context, content and status of the education and training completed and skills acquired; (b) \u2018diploma supplement\u2019 means a document attached to a higher education diploma issued by the competent authorities or bodies, in order to make it easier for third persons \u2013 particularly in another country \u2013 to understand the learning outcomes acquired by the holder of the qualification, as well as the nature, level, context, content and status of the education and training completed and skills acquired; (c) \u2018Europass supplements\u2019 means a set of documents, such as diploma supplements and certificate supplements, issued by the competent authorities or bodies; (d) \u2018guidance\u2019 means a continuous process that enables individuals to identify their capacities, skills and interests, through a range of individual and collective activities to make educational, training and occupational decisions and to manage their individual life paths in learning, work and other settings in which those capacities and skills are learned or used; (e) \u2018European dimension of guidance\u2019 means cooperation and support at Union level to strengthen policies, systems and practices for guidance within the Union; (f) \u2018qualification\u2019 means a formal outcome of an assessment and validation process which is obtained when a competent authority or body determines that an individual has achieved learning outcomes to given standards; (g) \u2018assessment of skills\u2019 means the process or method used to evaluate, measure and eventually describe, through self-assessment or assessment certified by a third party, or both, the skills of individuals acquired through formal, non-formal or informal settings; (h) \u2018self-assessment of skills\u2019 means the process of systematic reflection by individuals on their skills through reference to an established description of skills; (i) \u2018skills intelligence\u2019 means available quantitative or qualitative analysis of aggregated data on skills from existing sources in relation to the labour market and of corresponding learning opportunities in the education and training system which can contribute to guidance and counselling, recruitment processes, the choice of education, training and career paths; (j) \u2018authentication services\u2019 means technical processes, such as electronic signatures and website authentication, which allow users to verify information, such as their identity, through Europass; (k) \u2018technical interoperability\u2019 means the ability of information and communication technology systems to interact so as to enable the sharing of information, achieved through agreement by all parties and owners of the information; (l) \u2018validation\u2019 means the process by which a competent authority or body confirms that an individual has acquired learning outcomes, including those acquired in non-formal and informal learning settings, measured against a relevant standard, and which consists of four distinct phases, namely identification, documentation, assessment and certification of the results of the assessment in the form of a full qualification, credits or a partial qualification, as appropriate and in line with national circumstances; (m) \u2018open standards\u2019 means technical standards that have been developed in a collaborative process, and have been published for free use by any interested party; (n) \u2018online platform\u2019 means a web-based application that provides information and tools to end users and allows them to complete specific tasks online; (o) \u2018personal data\u2019 means any information relating to an identified or identifiable natural person. Article 3 Online platform 1. Europass shall provide, through an online platform, web-based tools for: (a) documenting and describing personal information in a variety of formats, including curriculum vitae (CV) templates; (b) documenting and describing skills and qualifications acquired through working and learning experiences, including through mobility and volunteering; (c) the assessment of skills and self-assessment of skills; (d) documenting the learning outcomes of qualifications, including the Europass supplement templates, as referred to in Article 5. The use of Europass tools for the assessment of skills and self-assessment of skills as referred to in point (c) shall not lead directly to formal recognition or the issuance of qualifications. 2. The Europass online platform shall provide available information or links to available information on the following topics: (a) learning opportunities; (b) qualifications and qualifications frameworks or systems; (c) opportunities for validation of non-formal and informal learning; (d) recognition practices and relevant legislation in different countries, including third countries; (e) services offering guidance for transnational learning mobility and career management; (f) skills intelligence as produced by relevant Union-level activities and agencies within their domains of competence; (g) information on skills and qualifications that could be relevant to the particular needs of third country nationals arriving or residing in the Union to support their integration. Article 4 Main principles and features 1. The Europass online platform and web-based tools, including their content and functionality, shall be user-friendly and secure and be made available free-of-charge to all users. 2. The Europass online platform and web-based tools, including their content and functionality, shall be accessible to persons with disabilities, in accordance with the accessibility requirements established in relevant Union law. 3. Europass web-based tools shall use open standards to be made available free of charge, for reuse by Member States and other stakeholders on a voluntary basis. 4. Europass web-based tools shall refer to the EQF in information on qualifications, descriptions of national education and training systems and other relevant topics, as appropriate and in line with national circumstances. 5. The Europass online platform may include an option for users to store personal data such as a personal profile. Union data protection law shall apply to the processing of such personal data. A number of options shall be made available to users to enable them to restrict access to their data or to certain attributes. 6. Europass shall support authentication services for any digital documents or representations of information on skills and qualifications. 7. Europass web-based tools shall be delivered in the official languages of the institutions of the Union. 8. Europass web-based tools shall support and ensure technical interoperability and synergies with other relevant instruments and services offered at Union and, where appropriate, national levels. Article 5 Europass supplements 1. Europass supplements shall be issued, in accordance with templates, by the competent authorities or bodies. In particular, the order of each item in the templates shall be respected, to ensure ease of understanding and the provision of complete information. 2. The templates referred to in paragraph 1 shall be developed and, when necessary, revised by the Commission, in close cooperation and consultation with the Member States and other stakeholders such as the Council of Europe and the United Nations Educational, Scientific and Cultural Organisation to ensure relevance and usability of the supplements. 3. Europass supplements shall be issued free of charge and, where possible, in electronic form. Europass supplements shall be issued in the national language and, where possible, in another European language. 4. Europass supplements shall not replace original diplomas or certificates and shall not amount to formal recognition of the original diploma or certificate by competent authorities or bodies of other countries. Article 6 The Commission's tasks 1. The Commission shall manage the Europass online platform. In that regard the Commission shall: (a) ensure the availability and high quality of Union-level information or links to such available information as referred to in Article 3(2); (b) develop, test and, when necessary, update the Europass online platform, including open standards, in line with user needs and technological advancements as well as changes in labour markets and in the provision of education and training; (c) keep up to date with and incorporate, where relevant, the latest technological developments that can improve the accessibility of Europass for older persons and persons with disabilities; (d) ensure that any development or updating of the Europass online platform, including open standards, supports consistency of information and demonstrates clear added value; (e) ensure that any web-based tools, in particular tools for assessment and self-assessment, are fully tested and quality-assured; and (f) ensure the quality and monitor the effectiveness of the Europass online platform including web-based tools in line with user needs. 2. The Commission shall ensure the effective implementation of this Decision. In that regard the Commission shall: (a) ensure the active participation and involvement of Member States in strategic planning, including setting and steering strategic objectives, quality assurance and financing, and take due regard of their positions; (b) ensure the active participation and involvement of Member States in the development, testing, updating and evaluation of the Europass online platform, including open standards, and take due regard of their positions; (c) ensure that, at Union level, relevant stakeholders are involved in the implementation and evaluation of this Decision; (d) set up learning activities and best practice exchanges between Member States and, where appropriate, facilitate peer counselling at the request of Member States; and (e) ensure that effective and adequate promotion, guidance and information activities are carried out at Union level in order to reach relevant users and stakeholders, including persons with disabilities. Article 7 Member States' tasks 1. Each Member State shall be responsible for the implementation of this Decision at national level through the relevant national services and without prejudice to national arrangements in terms of implementation and organisation. In that regard Member States shall: (a) coordinate the activities related to the implementation of Europass web-based tools; (b) promote the use and strengthen the awareness and visibility of Europass; (c) promote and provide information on services offering guidance for transnational learning mobility and career management, including, where appropriate, individual guidance services; (d) make information on learning opportunities, qualifications and recognition practices available on the Europass online platform, including through links to relevant national websites; (e) involve stakeholders from all relevant sectors, and promote cooperation among public and private stakeholders, in the activities under their responsibility. 2. The provision of information to the Europass online platform under Article 3(2) shall not create any additional obligations for Member States. Article 8 Data processing and protection The measures provided for in this Decision shall be carried out in accordance with Union law on protection of personal data, in particular Directive 95/46/EC of the European Parliament and of the Council (9) and Regulation (EC) No 45/2001 of the European Parliament and of the Council (10). Article 9 Monitoring and evaluation 1. The Commission shall report on progress and expected future developments following the adoption of this Decision, as appropriate, in the context of relevant education, training and employment policy frameworks. 2. By 23 May 2023, and every five years thereafter, the Commission shall submit to the European Parliament and to the Council an evaluation report on the implementation and impact of this Decision. 3. The evaluation shall be carried out by an independent body based on qualitative and quantitative indicators developed by the Commission in consultation with Member States. Article 10 Participating countries 1. Participation in the activities referred to in this Decision shall be open to members of the European Economic Area which are not Member States of the Union in accordance with the conditions laid down in the Agreement on the European Economic Area. 2. Participation shall also be open to acceding States, candidate States and potential candidate States for accession to the Union in accordance with their agreements concluded with the Union. Article 11 Financial provisions The implementation of this Decision at national level shall be co-financed through Union programmes. The annual appropriations shall be authorised by the European Parliament and the Council within the limits of the multiannual financial framework. Article 12 Repeal and transitional provisions 1. Decision No 2241/2004/EC is repealed. 2. The Europass internet-based information system established by Decision No 2241/2004/EC shall continue to operate until such time as the Europass online platform established by this Decision is set up and becomes operational. Article 13 Entry into force This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Done at Strasbourg, 18 April 2018. For the European Parliament The President A. TAJANI For the Council The President L. PAVLOVA (1) OJ C 173, 31.5.2017, p. 45. (2) Position of the European Parliament of 15 March 2018 (not yet published in the Official Journal) and decision of the Council of 12 April 2018. (3) Decision No 2241/2004/EC of the European Parliament and of the Council of 15 December 2004 on a single Community framework for the transparency of qualifications and competences (Europass) (OJ L 390, 31.12.2004, p. 6). (4) Council Recommendation of 22 May 2017 on the European Qualifications Framework for lifelong learning and repealing the recommendation of the European Parliament and of the Council of 23 April 2008 on the establishment of the European Qualifications Framework for lifelong learning (OJ C 189, 15.6.2017, p. 15). (5) Council Recommendation of 20 December 2012 on the validation of non-formal and informal learning (OJ C 398, 22.12.2012, p. 1). (6) Resolution of the Council and of the Representatives of the Governments of the Member States, meeting within the Council of 21 November 2008 on better integrating lifelong guidance into lifelong learning strategies (OJ C 319, 13.12.2008, p. 4). (7) Regulation (EU) 2016/589 of the European Parliament and of the Council of 13 April 2016 on a European network of employment services (EURES), workers' access to mobility services and the further integration of labour markets, and amending Regulations (EU) No 492/2011 and (EU) No 1296/2013 (OJ L 107, 22.4.2016, p. 1). (8) Regulation (EU) No 1288/2013 of the European Parliament and of the Council of 11 December 2013 establishing \u2018Erasmus+\u2019: the Union programme for education, training, youth and sport and repealing Decisions No 1719/2006/EC, No 1720/2006/EC and No 1298/2008/EC (OJ L 347, 20.12.2013, p. 50). (9) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (10) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).", "summary": "Europass \u2014 supporting learning and working in Europe Europass \u2014 supporting learning and working in Europe SUMMARY OF: Decision (EU) 2018/646 on a common framework for the provision of better services for skills and qualifications (Europass) WHAT IS THE AIM OF THE DECISION? It updates the Europass service to help people communicate their skills, qualifications and experience using standardised templates. This aims to meet the evolving needs of: individual users, such as learners, job-seekers, employers, workers and volunteers; relevant stakeholders, such as education, training and youth work providers, guidance providers, employers, public employment services, trades unions, youth organisations and policymakers. Europass is based on web-based tools and relevant available information. Its use is entirely voluntary. The decision repeals Decision No 2241/2004/EC. KEY POINTS Europass uses an online platform to provide: web-based tools to document and describe personal information in a variety of formats, including CV templates;document and describe skills* and qualifications acquired thorough work or education;assess and self-assess skills;access Europass supplement* templates; information on and links to learning opportunities;qualifications and their frameworks and systems;opportunities to validate non-formal and informal learning;mutual recognition practices in different countries;learning and career guidance for those looking abroad;resources of relevant EU-level activities and agencies;skills and qualifications of use to a non-EU national coming to, or living in, the EU. The online platform and the web-based tools and content: are user-friendly, secure, free of charge and accessible to people with disabilities; permit reuse by national authorities and other stakeholders; allow users to store data, such as a personal profile; exist in all EU official languages; support services to authenticate digital documents. Europass supplements: are issued by national authorities using the relevant template; are developed and updated by the European Commission in close cooperation with national governments, stakeholders, Council of Europe and the United Nations Educational, Scientific and Cultural Organisation (UNESCO); are issued free of charge, preferably electronically, in the national (or where possible another European) language; do not replace, or formally recognise, an original diploma or certificate. The Commission: manages the online platform; ensures the active participation of national authorities and stakeholders in implementing and developing the system; provides for exchange of best practice; ensures effective and adequate EU-wide promotion, guidance and information is available for users and stakeholders; must submit an evaluation report to the European Parliament and the Council by 23 May 2023 and again every 5 years. EU countries\u2019 national authorities are responsible for implementing the system and providing it with the necessary support and visibility, including links to relevant national websites. The Europass system: respects EU personal data protection legislation, especially Regulation (EU) 2016/679 on the protection of personal data and Regulation (EU) 2018/1725 on the protection of individuals with regard to the processing of personal data by EU institutions, bodies, offices and agencies; is open to other European countries; receives EU co-financing. FROM WHEN DOES THE DECISION APPLY? It has applied since 22 May 2018. BACKGROUND On 10 June 2016, the Commission issued a communication \u2018The New Skills Agenda for Europe\u2019. This was designed to make skills more visible and comparable to help individuals make better career choices. One of its 10 proposals was to update the original Europass framework adopted in 2004 (Decision No 2241/2004/EC). This contains a set of 5 templates to help people identify their skills and qualifications to create CVs and portfolios. Europass aims to reach all potential users, including the less-well educated, the elderly, the long-term unemployed and people with disabilities, as well as the highly educated and digitally literate. Since 2005, over 93 million document templates have been downloaded and over 60 million Europass CVs created online. For more information, see: Europass (European Commission). KEY TERMS Skills: what a person knows, understands and can do through formal, informal or non-formal learning. Europass supplements: documents, such as diplomas and certificates, issued by the relevant authority. MAIN DOCUMENT Decision (EU) 2018/646 of the European Parliament and of the Council of 18 April 2018 on a common framework for the provision of better services for skills and qualifications (Europass) and repealing Decision No 2241/2004/EC (OJ L 112, 2.5.2018, pp. 42-50) RELATED DOCUMENT Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 A New Skills Agenda for Europe: Working together to strengthen human capital, employability and competitiveness (COM(2016) 381 final, 10.6.2016) last update 28.06.2019"}
{"article": "16.7.2018 EN Official Journal of the European Union L 179/14 REGULATION (EU) 2018/974 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2018 on statistics of goods transport by inland waterways (codification) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 338(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Regulation (EC) No 1365/2006 of the European Parliament and of the Council (2) has been substantially amended several times (3). In the interests of clarity and rationality, that Regulation should be codified. (2) Inland waterways are an important part of the Union's transport networks and the promotion of inland waterways transport is one of the objectives of the common transport policy, both for reasons of economic efficiency and in order to reduce energy consumption and the environmental impact of transport. (3) The Commission needs statistics concerning the transport of goods by inland waterways in order to monitor and develop the common transport policy, as well as the transport elements of policies on the regions and on trans-European networks. (4) European statistics on all modes of transport should be collected according to common concepts and standards, with the aim of achieving the fullest practicable comparability between transport modes. (5) Inland waterways transport does not occur in all Member States and, therefore, the effect of this Regulation is limited to those Member States where this mode of transport exists. (6) Regulation (EC) No 223/2009 of the European Parliament and of the Council (4) provides a reference framework for the provisions laid down by this Regulation. (7) In order to take into account economic and technical trends and changes in definitions adopted at international level, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending this Regulation to raise the threshold above 1 000 000 tonnes for statistical coverage of inland waterways transport, to adapt definitions or provide for new ones, as well as to adapt the Annexes to this Regulation to reflect changes in coding and nomenclature at international level or in the relevant Union legislative acts. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (5). In particular, in order to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (8) The Commission should ensure that those delegated acts do not impose a significant additional burden on the Member States or on the respondents. (9) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission so as to enable it to adopt arrangements for transmitting data, including data interchange standards, for the dissemination of results by the Commission (Eurostat) and also to develop and to publish methodological requirements and criteria designed to ensure the quality of the data produced. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). (10) It is necessary for the Commission to arrange for pilot studies to be conducted on the availability of statistical data relating to passenger transport by inland waterways, including by cross border transport services. The Union should contribute to the cost of carrying out those pilot studies. Such contributions should take the form of grants awarded to the national statistical institutes and other national authorities referred to in Article 5 of Regulation (EC) No 223/2009, in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (7). (11) Since the objective of this Regulation, namely the creation of common statistical standards that permit the production of harmonised data, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale of that creation, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes common rules for the production of European statistics concerning inland waterways transport. Article 2 Scope 1. Member States shall transmit data relating to inland waterways transport on their national territory to the Commission (Eurostat). 2. Member States in which the total volume of goods transported annually by inland waterways as national, international or transit transport exceeds 1 000 000 tonnes shall supply the data referred to in Article 4(1). 3. By way of derogation from paragraph 2, Member States which do not have international or transit inland waterways transport but in which the total volume of goods transported annually by inland waterways as national transport exceeds 1 000 000 tonnes shall supply only the data required under Article 4(2). 4. This Regulation shall not apply to: (a) the carriage of goods by vessels of less than 50 deadweight tonnes; (b) vessels used principally for the carriage of passengers; (c) vessels used for ferrying purposes; (d) vessels used solely for non-commercial purposes by port administrations and public authorities; (e) vessels used solely for bunkering or storage; (f) vessels not used for the carriage of goods such as fishery vessels, dredgers, floating workshops, houseboats and pleasure craft. 5. The Commission is empowered to adopt delegated acts in accordance with Article 10 concerning the amendment of paragraph 2 of this Article in order to raise the threshold for statistical coverage of inland waterways transport referred to therein so as to take economic and technical trends into account. When exercising that power, the Commission shall ensure that the delegated acts do not impose a significant additional burden on the Member States or on the respondents. Furthermore, the Commission shall duly justify the statistical actions for which those delegated acts provide, using, where appropriate, a cost-effectiveness analysis, including an assessment of the burden on respondents and of the production costs as referred to in Article 14(3)(c) of Regulation (EC) No 223/2009. Article 3 Definitions For the purposes of this Regulation, the following definitions shall apply: (a) \u2018navigable inland waterway\u2019 means a watercourse, not part of the sea, which by natural or man-made features is suitable for navigation, primarily by inland waterway vessels; (b) \u2018inland waterway vessel\u2019 means a floating craft designed for the carriage of goods or public transport of passengers which navigates predominantly in navigable inland waterways or in waters within, or closely adjacent to sheltered waters or areas where port regulations apply; (c) \u2018nationality of the vessel\u2019 means the country where the vessel is registered; (d) \u2018inland waterways transport\u2019 means any movement of goods and/or passengers using inland waterways vessels which is undertaken wholly or partly in navigable inland waterways; (e) \u2018national inland waterways transport\u2019 means inland waterways transport between two ports of a national territory irrespective of the nationality of the vessel; (f) \u2018international inland waterways transport\u2019 means inland waterways transport between two ports located in different national territories; (g) \u2018transit inland waterways transport\u2019 means inland waterways transport through a national territory between two ports both located in another national territory or national territories provided that in the total journey within the national territory there is no transshipment; (h) \u2018inland waterways traffic\u2019 means any movement of a vessel on a given navigable inland waterway. The Commission is empowered to adopt delegated acts in accordance with Article 10 concerning the amendment of the first paragraph of this Article to adapt the definitions contained therein or to provide for new ones in order to take relevant definitions amended or adopted at international level into account. When exercising that power, the Commission shall ensure that the delegated acts do not impose a significant additional burden on the Member States or on the respondents. Furthermore, the Commission shall duly justify the statistical actions for which those delegated acts provide, using, where appropriate, a cost-effectiveness analysis, including an assessment of the burden on respondents and of the production costs as referred to in Article 14(3)(c) of Regulation (EC) No 223/2009. Article 4 Data collection 1. Data shall be collected in accordance with the tables set out in Annexes I to IV. 2. In the case referred to in Article 2(3), data shall be collected in accordance with the table set out in Annex V. 3. For the purposes of this Regulation, goods shall be classified in accordance with Annex VI. 4. The Commission is empowered to adopt delegated acts in accordance with Article 10 concerning the amendment of the Annexes to reflect changes in coding and nomenclature at international level or in the relevant Union legislative acts. When exercising that power, the Commission shall ensure that the delegated acts do not impose a significant additional burden on the Member States or on the respondents. Furthermore, the Commission shall duly justify the statistical actions for which those delegated acts provide, using, where appropriate, a cost-effectiveness analysis, including an assessment of the burden on respondents and of the production costs as referred to in Article 14(3)(c) of Regulation (EC) No 223/2009. Article 5 Pilot studies 1. By 8 December 2018, the Commission, in cooperation with the Member States, shall develop the appropriate methodology for compiling statistics on passenger transport by inland waterways, including by cross-border transport services. 2. By 8 December 2019, the Commission shall launch voluntary pilot studies to be carried out by Member States that provide data within the scope of this Regulation on the availability of statistical data relating to passenger transport by inland waterways, including by cross-border transport services. Those pilot studies shall aim to assess the feasibility of those new data collections, the costs of the related data collections and the statistical quality implied. 3. By 8 December 2020, the Commission shall submit a report to the European Parliament and to the Council on the results of such pilot studies. Depending on the results of that report, and within a reasonable period, the Commission shall submit, if appropriate, a legislative proposal to the European Parliament and to the Council to amend this Regulation with regard to statistics on passenger transport by inland waterways, including by cross-border transport services. 4. The general budget of the Union shall, where appropriate and taking into account the Union's added value, contribute to the financing of those pilot studies. Article 6 Transmission of data 1. The transmission of data shall take place as soon as possible and no later than five months after the end of the relevant period of observation. 2. The Commission shall adopt implementing acts laying down the arrangements for transmitting data to the Commission (Eurostat), including data interchange standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 7 Dissemination European statistics based on the data referred to in Article 4 shall be disseminated with a frequency similar to that laid down for the transmission of data by the Member States. The Commission shall adopt implementing acts laying down the arrangements for disseminating results. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 8 Quality of data 1. The Commission shall adopt implementing acts laying down the methodological requirements and criteria designed to ensure the quality of the data produced. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). 2. Member States shall take all measures necessary to ensure the quality of the data transmitted. 3. The Commission (Eurostat) shall assess the quality of the data transmitted. Member States shall supply the Commission (Eurostat) with a report containing such information and data as it may request in order to verify the quality of the data transmitted. 4. For the purposes of this Regulation, the quality criteria to be applied to the data to be transmitted are those referred to in Article 12(1) of Regulation (EC) No 223/2009. 5. The Commission shall adopt implementing acts laying down the detailed arrangements, structure, periodicity and comparability elements for the quality reports. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 9 Reports on implementation By 31 December 2020 and every five years thereafter, the Commission, after consulting the European Statistical System Committee, shall submit a report to the European Parliament and to the Council on the implementation of this Regulation and on future developments. In that report, the Commission shall take relevant information provided by Member States on potential improvements and on users' needs into account. In particular, that report shall assess: (a) the benefits accruing to the Union, the Member States and the providers and users of statistical information, of the statistics produced, in relation to their costs; (b) the quality of the data transmitted and the data collection methods used. Article 10 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 2(5), Article 3 and Article 4(4) shall be conferred on the Commission for a period of five years from 7 December 2016. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 2(5), Article 3 and Article 4(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 2(5), Article 3 or Article 4(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 11 Committee procedure 1. The Commission shall be assisted by the European Statistical System Committee established by Regulation (EC) No 223/2009. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 12 Repeal Regulation (EC) No 1365/2006 is hereby repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VIII. Article 13 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 4 July 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) Position of the European Parliament of 29 May 2018 (not yet published in the Official Journal) and Decision of the Council of 18 June 2018. (2) Regulation (EC) No 1365/2006 of the European Parliament and of the Council of 6 September 2006 on statistics of goods transport by inland waterways and repealing Council Directive 80/1119/EEC (OJ L 264, 25.9.2006, p. 1). (3) See Annex VII. (4) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (5) OJ L 123, 12.5.2016, p. 1. (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). ANNEX I Table I1. Goods transport by type of goods (annual data) Elements Coding Nomenclature Unit Table 2-alpha \u2018I1\u2019 Reporting country 2-letter NUTS0 (national code) Year 4-digit \u2018yyyy\u2019 Country/region of loading 4-alpha NUTS2 (1) Country/region of unloading 4-alpha NUTS2 (1) Type of transport 1-digit 1 = national 2 = international (except transit) 3 = transit Type of goods 2-digit NST 2007 Type of packaging 1-digit 1 = goods in containers 2 = goods not in containers and empty containers Tonnes transported tonnes Tonnes-km tonnes-km (1) When the regional code is unknown or not available, the following codification shall be used: \u2014 \u2018NUTS0 + ZZ\u2019 when the NUTS code exists for the partner country. \u2014 \u2018ISO code + ZZ\u2019 when the NUTS code does not exist for the partner country. \u2014 \u2018ZZZZ\u2019 when the partner country is completely unknown. ANNEX II Table II1. Transport by nationality of the vessel and type of vessel (annual data) Elements Coding Nomenclature Unit Table 3-alpha \u2018II1\u2019 Reporting country 2-letter NUTS0 (national code) Year 4-digit \u2018yyyy\u2019 Country/region of loading 4-alpha NUTS2 (1) Country/region of unloading 4-alpha NUTS2 (1) Type of transport 1-digit 1 = national 2 = international (except transit) 3 = transit Type of vessel 1-digit 1 = self-propelled barge 2 = barge not self-propelled 3 = self-propelled tanker barge 4 = tanker barge not self-propelled 5 = other goods-carrying vessel 6 = seagoing vessel Nationality of vessel 2-letter NUTS0 (national code) (2) Tonnes transported tonnes Tonnes-km tonnes-km Table II2. Vessel traffic (annual data) Elements Coding Nomenclature Unit Table 3-Alpha \u2018II2\u2019 Reporting country 2-letter NUTS0 (national code) Year 4-digit \u2018yyyy\u2019 Type of transport 1-digit 1 = national 2 = international (except transit) 3 = transit Number of movements of loaded vessels movements of vessels Number of movements of empty vessels movements of vessels Vessel-km (loaded vessels) vessel-km Vessel-km (empty vessels) vessel-km NOTE: The provision of Table II2 is optional. (1) When the regional code is unknown or not available, the following codification shall be used: \u2014 \u2018NUTS0 + ZZ\u2019 when the NUTS code exists for the partner country. \u2014 \u2018ISO code + ZZ\u2019 when the NUTS code does not exist for the partner country. \u2014 \u2018ZZZZ\u2019 when the partner country is completely unknown. (2) When a NUTS code does not exist for the country of registration of the vessel, the ISO national code shall be reported. Where the nationality of the vessel is unknown, the code to use is \u2018ZZ\u2019. ANNEX III Table III1. Container transport by type of goods (annual data) Elements Coding Nomenclature Unit Table 4-alpha \u2018III1\u2019 Reporting country 2-letter NUTS0 (national code) Year 4-digit \u2018yyyy\u2019 Country/region of loading 4-alpha NUTS2 (1) Country/region of unloading 4-alpha NUTS2 (1) Type of transport 1-digit 1 = national 2 = international (except transit) 3 = transit Size of containers 1-digit 1 = 20\u2032 freight units 2 = 40\u2032 freight units 3 = freight units > 20\u2032 and < 40\u2032 4 = freight units > 40\u2032 Loading status 1-digit 1 = loaded containers 2 = empty containers Type of goods 2-digit NST 2007 Tonnes transported tonnes tonnes-km tonnes-km TEU TEU TEU-km TEU-km (1) When the regional code is unknown or not available, the following codification shall be used: \u2014 \u2018NUTS0 + ZZ\u2019 when the NUTS code exists for the partner country. \u2014 \u2018ISO code + ZZ\u2019 when the NUTS code does not exist for the partner country. \u2014 \u2018ZZZZ\u2019 when the partner country is completely unknown. ANNEX IV Table IV1. Transport by nationality of vessels (quarterly data) Elements Coding Nomenclature Unit Table 3-alpha \u2018IV1\u2019 Reporting country 2-letter NUTS0 (national code) Year 4-digit \u2018yyyy\u2019 Quarter 2-digit 41 = quarter 1 42 = quarter 2 43 = quarter 3 44 = quarter 4 Type of transport 1-digit 1 = national 2 = international (except transit) 3 = transit Nationality of the vessel 2-letter NUTS0 (national code) (1) Tonnes transported tonnes Tonnes-km tonnes-km Table IV2. Container transport by nationality of vessels (quarterly data) Elements Coding Nomenclature Unit Table 3-alpha \u2018IV2\u2019 Reporting country 2-letter NUTS0 (national code) Year 4-digit \u2018yyyy\u2019 Quarter 2-digit 41 = quarter 1 42 = quarter 2 43 = quarter 3 44 = quarter 4 Type of transport 1-digit 1 = national 2 = international (except transit) 3 = transit Nationality of vessel 2-letter NUTS0 (national code) (2) Loading status 1-digit 1 = loaded containers 2 = empty containers Tonnes transported tonnes Tonnes-km tonnes-km TEU TEU TEU-km TEU-km (1) When a NUTS code does not exist for the country of registration of the vessel, the ISO national code shall be reported. Where the nationality of the vessel is unknown, the code to use is \u2018ZZ\u2019. (2) When a NUTS code does not exist for the country of registration of the vessel, the ISO national code shall be reported. Where the nationality of the vessel is unknown, the code to use is \u2018ZZ\u2019. ANNEX V Table V1. Goods transport (annual data) Elements Coding Nomenclature Unit Table 2-alpha \u2018V1\u2019 Reporting country 2-letter NUTS0 (national code) Year 4-digit \u2018yyyy\u2019 Type of transport 1-digit 1 = national 2 = international (except transit) 3 = transit Type of goods 2-digit NST 2007 Tonnes transported tonnes Tonnes-km tonnes-km ANNEX VI NST 2007 Division Description 01 Products of agriculture, hunting, and forestry; fish and other fishing products 02 Coal and lignite; crude petroleum and natural gas 03 Metal ores and other mining and quarrying products; peat; uranium and thorium 04 Food products, beverages and tobacco 05 Textiles and textile products; leather and leather products 06 Wood and products of wood and cork (except furniture); articles of straw and plaiting materials; pulp, paper and paper products; printed matter and recorded media 07 Coke and refined petroleum products 08 Chemicals, chemical products, and man-made fibres; rubber and plastic products; nuclear fuel 09 Other non-metallic mineral products 10 Basic metals; fabricated metal products, except machinery and equipment 11 Machinery and equipment n.e.c.; office machinery and computers; electrical machinery and apparatus n.e.c.; radio, television and communication equipment and apparatus; medical, precision and optical instruments; watches and clocks 12 Transport equipment 13 Furniture; other manufactured goods n.e.c. 14 Secondary raw materials; municipal wastes and other wastes 15 Mail, parcels 16 Equipment and material utilised in the transport of goods 17 Goods moved in the course of household and office removals; baggage transported separately from passengers; motor vehicles being moved for repair; other non-market goods n.e.c. 18 Grouped goods: a mixture of types of goods which are transported together 19 Unidentifiable goods: goods which for any reason cannot be identified and therefore cannot be assigned to groups 01\u201416 20 Other goods n.e.c. ANNEX VII REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Regulation (EC) No 1365/2006 of the European Parliament and of the Council (OJ L 264, 25.9.2006, p. 1). Commission Regulation (EC) No 425/2007 (OJ L 103, 20.4.2007, p. 26). Only Article 1 Commission Regulation (EC) No 1304/2007 (OJ L 290, 8.11.2007, p. 14). Only Article 4 Regulation (EU) 2016/1954 of the European Parliament and of the Council (OJ L 311, 17.11.2016, p. 20). ANNEX VIII Correlation Table Regulation (EC) No 1365/2006 This Regulation Articles 1 to 4 Articles 1 to 4 Article 4a Article 5 Article 5 Article 6 Article 6 Article 7 Article 7 Article 8 Article 8 Article 9 Article 10 Article 11 Article 11 \u2014 \u2014 Article 12 Article 12 Article 13 Annex A Annex I Annex B Annex II Annex C Annex III Annex D Annex IV Annex E Annex V Annex F Annex VI \u2014 Annex VII \u2014 Annex VIII", "summary": "EU statistics of goods transport by inland waterways EU statistics of goods transport by inland waterways SUMMARY OF: Regulation (EU) 2018/974 on statistics of goods transport by inland waterways WHAT IS THE AIM OF THE REGULATION? It sets out the rules for the production of comparable EU-wide statistics on inland waterways freight transport. It seeks to provide a picture of the volume and performance of freight transport on the EU inland waterway network. It codifies and repeals Regulation (EC) No 1365/2006 which had been substantially amended several times. KEY POINTS Scope EU countries must each compile and transmit to the European Commission (Eurostat) data relating to inland waterways transport. The regulation does not apply to the carriage of goods by vessels of less than 50 deadweight tonnes or to vessels: used mainly for transporting passengers; used for ferrying purposes; used solely for non-commercial purposes by port authorities and public authorities; used solely for bunkering or storage; not used to carry goods such as fishery vessels, dredgers, floating workshops, houseboats and pleasure craft. EU countries in which the total volume of goods transported annually by inland waterways \u2014 national, international or transit \u2014 exceeds 1 million tonnes must provide data stipulated in the tables in Annexes I to IV to the regulation. EU countries which do not have international or transit inland waterways transport, but in which the total volume of goods transported annually by inland waterways as national transport exceeds 1 million tonnes, shall supply only the data required by Annex V to the regulation. The effect of this regulation is limited to those countries in which this mode of transport exists. Pilot studies By 8 December 2018, the European Commission, in cooperation with EU countries, is to develop the appropriate methodology for compiling statistics on passenger transport by inland waterways, including by cross-border transport services. In 2019, the Commission will launch voluntary pilot studies to be carried out by EU countries that provide data within the scope of this regulation on the availability of statistical data relating to passenger transport by inland waterways. The studies shall assess the feasibility of those new data collections, the costs of the related data collections and the statistical quality implied. By 8 December 2020, the Commission shall submit a report to the European Parliament and to the Council on the results of the pilot studies. Data collection and transmission Data are reported on the basis of the territoriality principle whereby each country reports the loading, unloading and movements of goods that take place on its national territory. The tables in Annexes I to V to the regulation lay down the rules and formats for data collection. EU countries must transmit to Eurostat the data they have gathered no later than 5 months after the end of the relevant period of observation. The Commission is to adopt implementing acts laying down the arrangements for transmitting data to Eurostat. Dissemination of data Eurostat disseminates the data at a frequency similar to that laid down for the transmission of data (quarterly or annually). Quality of data The Commission is to adopt implementing acts laying down the methodological requirements and criteria designed to ensure the quality of the data produced. EU countries must ensure the quality of data transmitted and supply the Commission (Eurostat) with a report containing such information and data as it may request in order to verify the quality of the data transmitted. Reports on implementation The Commission (Eurostat) shall report for the first time by 31 December 2020, and thereafter every 5 years, to the European Parliament and the Council on the regulation\u2019s implementation and on future developments. Committee procedure The Commission is advised and assisted by the European Statistical System Committee established by Regulation (EC) No 223/2009 (How the European Statistical System works). FROM WHEN DOES THE REGULATION APPLY? It has applied since 5 August 2018. Regulation (EU) 2018/974 codifies and replaces Regulation (EC) No 1365/2006 and its subsequent amendments. BACKGROUND For more information, see: Inland waterways transport statistics (Eurostat). MAIN DOCUMENT Regulation (EU) 2018/974 of the European Parliament and of the Council of 4 July 2018 on statistics of goods transport by inland waterways (codification) (OJ L 179, 16.7.2018, pp. 14-29) RELATED DOCUMENTS Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, pp. 164-173) Successive amendments to Regulation (EC) No 223/2009 have been incorporated in the original text. This consolidated version is of documentary value only. Regulation (EC) No 1365/2006 of the European Parliament and of the Council of 6 September 2006 on statistics of goods transport by inland waterways and repealing Council Directive 80/1119/EEC (OJ L 264, 25.9.2006, pp. 1-11) See consolidated version. last update 19.09.2018"}
{"article": "2.5.2018 EN Official Journal of the European Union L 112/1 REGULATION (EU) 2018/643 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 April 2018 on rail transport statistics (recast) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 338(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Regulation (EC) No 91/2003 of the European Parliament and of the Council (3) has been substantially amended several times (4). Since further amendments are to be made, that Regulation should be recast in the interests of clarity. (2) Railways are an important part of the Union's transport networks. (3) Statistics on the transport of goods and passengers by rail are necessary to enable the Commission to monitor and develop the common transport policy, as well as the transport elements of policies relating to the regions and to trans-European networks. (4) Statistics on rail safety are also necessary to enable the Commission to prepare and monitor Union action in the field of transport safety. The European Union Agency for Railways collects data on accidents under Annex I to Directive 2004/49/EC of the European Parliament and of the Council (5) as regards common safety indicators and common methods of calculating accident costs. (5) Statistics at Union level on rail transport are also required in order to fulfil the monitoring tasks provided for in Article 15 of Directive 2012/34/EU of the European Parliament and of the Council (6). (6) Statistics at Union level on all modes of transport should be collected according to common concepts and standards, with the aim of achieving the fullest practicable comparability between transport modes. (7) It is important to avoid duplication of work and to optimise the use of existing information that is capable of being used for statistical purposes. To that end, and with a view to providing easily accessible and useful information to Union citizens and other stakeholders on rail transport safety and interoperability of the rail system, including the rail infrastructure, appropriate cooperation agreements on statistical activities should be established between the Commission's services and relevant entities, including at international level. (8) A balance should be struck between the needs of the users and the burden on respondents when producing European statistics. (9) In its report to the European Parliament and to the Council on its experience acquired in applying Regulation (EC) No 91/2003, the Commission referred to the fact that long-term developments will probably result in the suppression or the simplification of the data already collected under that Regulation, and that the aim is to reduce the data transmission period for annual data on rail passengers. The Commission should continue to provide reports at regular intervals on the implementation of this Regulation. (10) The coexistence of publicly and privately owned railway undertakings operating in a commercial rail transport market requires an explicit specification of the statistical information which should be provided by all railway undertakings and disseminated by Eurostat. (11) Since the objective of this Regulation, namely the creation of common statistical standards which permit the production of harmonised data and which are to be implemented in each Member State under the authority of the bodies and institutions in charge of producing official statistics, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (12) Regulation (EC) No 223/2009 of the European Parliament and of the Council (7) provides a reference framework for the provisions laid down by this Regulation. (13) In order to reflect new developments in the Member States while, at the same time, maintaining the harmonised collection of rail transport data across the Union, and with a view to maintaining the high quality of the data transmitted by the Member States, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending this Regulation to adapt the technical definitions and to provide for additional technical definitions. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (8). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (14) The Commission should ensure that those delegated acts do not impose a significant additional burden on the Member States or on the respondents. (15) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the specification of the information to be supplied for the reports on the quality and comparability of the results, and the arrangements for the dissemination of those results by the Commission (Eurostat). Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (9). (16) The European Statistical System Committee has been consulted, HAVE ADOPTED THIS REGULATION: Article 1 Objective The objective of this Regulation is to establish common rules for the production of rail transport statistics at Union level. Article 2 Scope This Regulation shall cover all railways in the Union. Each Member State shall report statistics which relate to rail transport on its national territory. Where a railway undertaking operates in more than one Member State, the national authorities concerned shall require the undertaking to provide data separately for each country in which it operates so as to enable national statistics to be compiled. Member States may exclude from the scope of this Regulation: (a) railway undertakings which operate entirely or mainly within industrial and similar installations, including harbours; (b) railway undertakings which mainly provide local tourist services, such as preserved historical steam railways. Article 3 Definitions 1. For the purposes of this Regulation, the following definitions apply: (1) \u2018reporting country\u2019 means the Member State transmitting data to Eurostat; (2) \u2018national authorities\u2019 means national statistical institutes and other bodies responsible in each Member State for producing European statistics; (3) \u2018railway\u2019 means a line of communication made up by rail exclusively for the use of railway vehicles; (4) \u2018railway vehicle\u2019 means mobile equipment running exclusively on rails, moving either under its own power (tractive vehicles) or hauled by another vehicle (coaches, railcar trailers, vans and wagons); (5) \u2018railway undertaking\u2019 means any public or private undertaking which provides services for the transport of goods and/or passengers by rail. Undertakings whose only business is to provide services for the transport of passengers by metro, tram and/or light rail are excluded; (6) \u2018transport of goods by rail\u2019 means the movement of goods using railway vehicles between the place of loading and the place of unloading; (7) \u2018transport of passengers by rail\u2019 means the movement of passengers using railway vehicles between the place of embarkation and the place of disembarkation. The transport of passengers by metro, tram and/or light rail is excluded; (8) \u2018metro\u2019 (also known as \u2018subway\u2019, \u2018metropolitan railway\u2019 or \u2018underground\u2019) means an electric railway for the transport of passengers with the capacity for a heavy volume of traffic and characterised by exclusive rights-of-way, multi-car trains, high speed and rapid acceleration, sophisticated signalling as well as the absence of level crossings to allow a high frequency of trains and high platform load. Metros are also characterised by closely spaced stations, normally meaning a distance of 700 to 1 200 m between the stations. \u2018High speed\u2019 refers to the comparison with trams and light rail, and means here approximately 30 to 40 km/h on shorter distances, 40 to 70 km/h on longer distances; (9) \u2018tram (streetcar)\u2019 means a passenger road vehicle designed to seat more than nine persons (including the driver), which is connected to electric conductors or powered by diesel engine and which is rail-borne; (10) \u2018light rail\u2019 means a railway for the transport of passengers that often uses electrically powered rail-borne cars operating singly or in short trains on fixed duo-rail lines. There is generally a distance of less than 1 200 m between stations/stops. In comparison to metros, light rail is more lightly constructed, is designed for lower traffic volumes and usually travels at lower speeds. It is sometimes difficult to make a precise distinction between light rail and trams; trams are generally not separated from road traffic, whereas light rail may be separated from other systems; (11) \u2018national transport\u2019 means rail transport between two places (a place of loading/embarkation and a place of unloading/disembarkation) located in the reporting country. It may involve transit through a second country; (12) \u2018international transport\u2019 means rail transport between a place (of loading/embarkation or unloading/disembarkation) in the reporting country and a place (of loading/embarkation or unloading/disembarkation) in another country; (13) \u2018transit\u2019 means rail transport through the reporting country between two places (a place of loading/embarkation and a place of unloading/disembarkation) outside the reporting country. Transport operations involving loading/embarkation or unloading/disembarkation of goods/passengers at the border of the reporting country from/onto another mode of transport are not considered as transit; (14) \u2018rail passenger\u2019 means any person, excluding members of the train crew, who makes a trip by rail. For accident statistics, passengers trying to embark/disembark onto/from a moving train are included; (15) \u2018number of passengers\u2019 means the number of trips by rail passengers, where each trip is defined as the movement from the place of embarkation to the place of disembarkation, with or without transfers from one rail vehicle to another. If passengers use the services of more than one railway undertaking, when possible they shall not be counted more than once; (16) \u2018passenger-km\u2019 means the unit of measure representing the transport of one passenger by rail over a distance of one kilometre. Only the distance on the national territory of the reporting country shall be taken into account; (17) \u2018weight\u2019 means the quantity of goods in tonnes (1 000 kilograms). The weight to be taken into consideration includes, in addition to the weight of the goods transported, the weight of packaging and the tare weight of containers, swap bodies, pallets as well as road vehicles transported by rail in the course of combined transport operations. If the goods are transported using the services of more than one railway undertaking, when possible the weight of goods shall not be counted more than once; (18) \u2018tonne-km\u2019 means the unit of measure of goods transport which represents the transport of one tonne (1 000 kilograms) of goods by rail over a distance of one kilometre. Only the distance on the national territory of the reporting country shall be taken into account; (19) \u2018train\u2019 means one or more railway vehicles hauled by one or more locomotives or railcars, or one railcar travelling alone, running under a given number or specific designation from an initial fixed point to a terminal fixed point. A light engine, that is to say, a locomotive travelling on its own, is not considered to be a train; (20) \u2018train-km\u2019 means the unit of measure representing the movement of a train over one kilometre. The distance used is the distance actually run, if available, otherwise the standard network distance between the origin and destination shall be used. Only the distance on the national territory of the reporting country shall be taken into account; (21) \u2018full train load\u2019 means any consignment comprising one or more wagonloads transported at the same time by the same sender at the same station and forwarded with no change in train composition to the address of the same consignee at the same destination station; (22) \u2018full wagon load\u2019 means any consignment of goods for which the exclusive use of a wagon is required, whether or not the total loading capacity is utilised; (23) \u2018TEU (Twenty-foot Equivalent Unit)\u2019 means a standard unit based on an ISO container of 20 feet length (6,10 m), used as a statistical measure of traffic flows or capacities. One standard 40' ISO Series 1 container equals 2 TEUs. Swap bodies under 20 feet correspond to 0,75 TEU, between 20 feet and 40 feet to 1,5 TEU and over 40 feet to 2,25 TEU. 2. The Commission is empowered to adopt delegated acts in accordance with Article 10 amending this Article to adapt the technical definitions set out in points (8), (9), (10), (21), (22) and (23) of paragraph 1 of this Article and to provide for additional technical definitions, when needed to take into account new developments which require a certain level of technical detail to be defined in order to ensure the harmonisation of statistics. When exercising that power the Commission shall ensure that the delegated acts do not impose a significant additional burden on the Member States or on the respondents. Furthermore, the Commission shall duly justify the statistical actions for which those delegated acts provide, using, where appropriate, cost-effectiveness analysis, including an assessment of the burden on respondents and of the production costs, as referred to in point (c) of Article 14(3) of Regulation (EC) No 223/2009. Article 4 Data collection 1. The statistics to be collected are set out in the Annexes to this Regulation. They shall cover the following types of data: (a) annual statistics on goods transport \u2014 detailed reporting (Annex I); (b) annual statistics on passenger transport \u2014 detailed reporting (Annex II); (c) quarterly statistics on goods and passenger transport (Annex III); (d) regional statistics on goods and passenger transport (Annex IV); (e) statistics on traffic flows on the rail network (Annex V). 2. Member States shall report under Annexes I and II data for undertakings that have: (a) a total volume of goods transport of at least 200 000 000 tonne-km or at least 500 000 tonnes; (b) a total volume of passenger transport of at least 100 000 000 passenger-km. Reporting under Annexes I and II shall be optional in respect of undertakings falling below the thresholds referred to in points (a) and (b). 3. Member States shall report under Annex VIII the total data for undertakings falling below the thresholds referred to in paragraph 2 if those data are not reported under Annexes I and II, as specified in Annex VIII. 4. For the purposes of this Regulation, goods shall be classified in accordance with Annex VI. Dangerous goods shall additionally be classified in accordance with Annex VII. Article 5 Data sources 1. Member States shall designate a public or private organisation to participate in collecting the data required in accordance with this Regulation. 2. The necessary data may be obtained using any combination of the following sources: (a) compulsory surveys; (b) administrative data, including data collected by regulatory authorities, in particular the rail freight waybill if one is available; (c) statistical estimation procedures; (d) data supplied by professional organisations in the rail industry; (e) ad hoc studies. 3. The national authorities shall take measures for the coordination of the data sources used and to ensure the quality of the statistics transmitted to Eurostat. Article 6 Transmission of statistics to Eurostat 1. Member States shall transmit the statistics referred to in Article 4 to Eurostat. 2. The Commission shall adopt implementing acts laying down the arrangements for the transmission of the statistics referred to in Article 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 7 Dissemination 1. Statistics based on the data specified in Annexes I to V and VIII shall be disseminated by the Commission (Eurostat). 2. The Commission shall adopt implementing acts laying down the arrangements for the dissemination of results. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 8 Quality of statistics 1. In order to assist Member States in maintaining the quality of statistics in the domain of rail transport, Eurostat shall develop and publish methodological recommendations. These recommendations shall take account of the best practices of national authorities, of railway undertakings and of professional organisations for the railway industry. 2. Member States shall take all measures necessary to ensure the quality of the data transmitted. 3. The quality of the statistical data shall be evaluated by Eurostat. To this end, on request by Eurostat, Member States shall supply information on the methods used in producing the statistics. 4. For the purposes of this Regulation, the quality criteria to be applied to the data to be transmitted are those referred to in Article 12(1) of Regulation (EC) No 223/2009. 5. The Commission shall adopt implementing acts specifying the detailed arrangements, structure, periodicity and comparability elements for the standard quality reports. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 9 Reports on implementation By 31 December 2020 and every four years thereafter, the Commission, after consulting the European Statistical System Committee, shall submit a report to the European Parliament and to the Council on the implementation of this Regulation and on future developments. In that report, the Commission shall take account of relevant information provided by Member States relating to the quality of the data transmitted, the data collection methods used and information on potential improvements and on users' needs. In particular, that report shall: (a) assess the benefits, accruing to the Union, the Member States and the providers and users of statistical information, of the statistics produced, in relation to their costs; (b) assess the quality of the data transmitted, the data collection methods used and the quality of the statistics produced. Article 10 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3(2) shall be conferred on the Commission for a period of five years from 13 December 2016. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 3(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 3(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 11 Committee procedure 1. The Commission shall be assisted by the European Statistical System Committee established by Regulation (EC) No 223/2009. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 12 Repeal Regulation (EC) No 91/2003 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex X. Article 13 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 18 April 2018. For the European Parliament The President A. TAJANI For the Council The President L. PAVLOVA (1) Opinion of 6 December 2017 (not yet published in the Official Journal). (2) Position of the European Parliament of 14 March 2018 (not yet published in the Official Journal), and decision of the Council of 12 April 2018. (3) Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics (OJ L 14, 21.1.2003, p. 1). (4) See Annex IX. (5) Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) (OJ L 164, 30.4.2004, p. 44). (6) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32). (7) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (8) OJ L 123, 12.5.2016, p. 1. (9) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). ANNEX I ANNUAL STATISTICS ON GOODS TRANSPORT \u2014 DETAILED REPORTING List of variables and units of measurement Goods transported in: \u2014 tonnes \u2014 tonne-km Goods train movements in: \u2014 train-km Number of intermodal transport units carried in: \u2014 number \u2014 TEU (20-foot-equivalent unit) (for containers and swap bodies) Reference period One year Frequency Every year List of tables with the breakdown for each table Table I1: goods transported, by type of transport Table I2: goods transported, by type of goods (Annex VI) Table I3: goods transported (for international and transit traffic) by country of loading and country of unloading Table I4: goods transported, by category of dangerous goods (Annex VII) Table I5: goods transported, by type of consignment (optional) Table I6: goods transported in intermodal transport units, by type of transport and by type of transport unit Table I7: number of loaded intermodal transport units carried, by type of transport and by type of transport unit Table I8: number of empty intermodal transport units carried, by type of transport and by type of transport unit Table I9: goods train movements Deadline for transmission of data Five months after end of reference period First reference period for tables I1, I2 and I3 2003 First reference period for tables I4, I5, I6, I7, I8 and I9 2004 Notes 1. Type of transport is broken down as follows: \u2014 national \u2014 international-incoming \u2014 international-outgoing \u2014 transit 2. Type of consignment may be broken down as follows: \u2014 full train loads \u2014 full wagon loads \u2014 other 3. Type of transport unit is broken down as follows: \u2014 containers and swap bodies \u2014 semi-trailers (unaccompanied) \u2014 road vehicles (accompanied) 4. For Table I3, Eurostat and the Member States may make arrangements to facilitate consolidation of data originating from undertakings in other Member States, in order to ensure the coherence of these data. 5. For Table I4, Member States shall indicate which categories of traffic, if any, are not covered by the data. 6. For tables I2 to I8 where complete information on transit transport is not available, Member States shall report all available data. ANNEX II ANNUAL STATISTICS ON PASSENGER TRANSPORT \u2014 DETAILED REPORTING List of variables and units of measurement Passengers transported in: \u2014 number of passengers \u2014 passenger-km Passenger train movements in: \u2014 train-km Reference period One year Frequency Every year List of tables with the breakdown for each table Table II1: passengers transported, by type of transport Table II2: international passengers transported, by country of embarkation and by country of disembarkation Table II3: passenger train movements Deadline for transmission of data Eight months after end of reference period First reference period 2016 Notes 1. Type of transport is broken down as follows: \u2014 national \u2014 international 2. For Tables II1 and II2, Member States shall report data including information from ticket sales outside the reporting country. This information may be obtained either directly from the national authorities of other countries or through international compensation arrangements for tickets. ANNEX III QUARTERLY STATISTICS ON GOODS AND PASSENGER TRANSPORT List of variables and units of measurement Goods transported in: \u2014 tonnes \u2014 tonne-km Passengers transported in: \u2014 number of passengers \u2014 passenger-km Reference period One quarter Frequency Every quarter List of tables with the breakdown for each table Table III1: goods transported Table III2: passengers transported Deadline for transmission of data Three months after end of reference period First reference period First quarter of 2004 Notes 1. Tables III1 and III2 may be reported on the basis of provisional data, including estimates. For Table III2, Member States may report data based on ticket sales in the reporting country or any other available source. 2. These statistics shall be supplied for the undertakings covered by Annexes I and II. ANNEX IV REGIONAL STATISTICS ON GOODS AND PASSENGER TRANSPORT List of variables and units of measurement Goods transported in: \u2014 tonnes Passengers transported in: \u2014 number of passengers Reference period One year Frequency Every five years List of tables with the breakdown for each table Table IV1: national goods transport by region of loading and region of unloading (NUTS 2) Table IV2: international goods transport by region of loading and unloading (NUTS 2) Table IV3: national passenger transport by region of embarkation and region of disembarkation (NUTS 2) Table IV4: international passenger transport by region of embarkation and region of disembarkation (NUTS 2) Deadline for transmission of data 12 months after end of reference period First reference period 2005 Notes 1. Where the place of loading or unloading (Tables IV1, IV2) or embarkation or disembarkation (Tables IV3, IV4) is outside the European Economic Area, Member States shall report only the country. 2. In order to assist Member States in the preparation of these tables, Eurostat shall provide Member States with a list of UIC station codes and the corresponding NUTS codes. 3. For Tables IV3 and IV4, Member States may report data based on ticket sales or any other available source. 4. These statistics shall be supplied for the undertakings covered by Annexes I and II. ANNEX V STATISTICS ON TRAFFIC FLOWS ON THE RAIL NETWORK List of variables and units of measurement Goods transport: \u2014 number of trains Passenger transport: \u2014 number of trains Other (service trains, etc.) (optional): \u2014 number of trains Reference period One year Frequency Every five years List of tables with the breakdown for each table Table V1: goods transport, by network segment Table V2: passenger transport, by network segment Table V3: other (service trains, etc.), by network segment (optional) Deadline for transmission of data 18 months after end of reference period First reference period 2005 Notes 1. Member States shall define a set of network segments to include at least the rail trans-European network (TEN) on their national territory. They shall communicate to Eurostat: \u2014 the geographical coordinates and other data needed to identify and map each network segment as well as the links between segments, \u2014 information on the characteristics (including the capacity) of the trains using each network segment. 2. Each network segment which is part of the rail TEN shall be identified by means of an additional attribute in the data record, in order to enable traffic on the rail TEN to be quantified. ANNEX VI NST 2007 Division Description 01 Products of agriculture, hunting, and forestry; fish and other fishing products 02 Coal and lignite; crude petroleum and natural gas 03 Metal ores and other mining and quarrying products; peat; uranium and thorium 04 Food products, beverages and tobacco 05 Textiles and textile products; leather and leather products 06 Wood and products of wood and cork (except furniture); articles of straw and plaiting materials; pulp, paper and paper products; printed matter and recorded media 07 Coke and refined petroleum products 08 Chemicals, chemical products, and man-made fibres; rubber and plastic products; nuclear fuel 09 Other non-metallic mineral products 10 Basic metals; fabricated metal products, except machinery and equipment 11 Machinery and equipment n.e.c.; office machinery and computers; electrical machinery and apparatus n.e.c.; radio, television and communication equipment and apparatus; medical, precision and optical instruments; watches and clocks 12 Transport equipment 13 Furniture; other manufactured goods n.e.c. 14 Secondary raw materials; municipal wastes and other wastes 15 Mail, parcels 16 Equipment and material utilised in the transport of goods 17 Goods moved in the course of household and office removals; baggage transported separately from passengers; motor vehicles being moved for repair; other non-market goods n.e.c. 18 Grouped goods: a mixture of types of goods which are transported together 19 Unidentifiable goods: goods which for any reason cannot be identified and therefore cannot be assigned to groups 01\u201316 20 Other goods n.e.c. ANNEX VII CLASSIFICATION OF DANGEROUS GOODS 1. Explosives 2. Gases, compressed, liquefied or dissolved under pressure 3. Flammable liquids 4.1. Flammable solids 4.2. Substances liable to spontaneous combustion 4.3. Substances which, in contact with water, emit flammable gases 5.1. Oxidising substances 5.2. Organic peroxides 6.1. Toxic substances 6.2. Substances liable to cause infections 7. Radioactive material 8. Corrosives 9. Miscellaneous dangerous substances Note: These categories are those defined in the regulations concerning the international carriage of dangerous goods by rail, usually known as the RID, as adopted under Directive 2008/68/EC of the European Parliament and of the Council (1). (1) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13). ANNEX VIII Table VIII.1 LEVEL OF TRANSPORT ACTIVITY IN GOODS TRANSPORT List of variables and units of measurement Goods transported in: \u2014 total tonnes \u2014 total tonne-km Goods train movements in: \u2014 total train-km Reference period One year Frequency Every year Deadline for transmission of data Five months after end of reference period First reference period 2017 Notes Only for undertakings with a total volume of freight transport of less than 200 million tonne-km and less than 500 000 tonnes and not reporting under Annex I (detailed reporting). Table VIII.2 LEVEL OF TRANSPORT ACTIVITY IN PASSENGER TRANSPORT List of variables and units of measurement Passengers transported in: \u2014 total passengers \u2014 total passenger-km Passenger train movements in: \u2014 total train-km Reference period One year Frequency Every year Deadline for transmission of data Eight months after end of reference period First reference period 2017 Notes Only for undertakings with a total volume of passenger transport of less than 100 million passenger-km and not reporting under Annex II (detailed reporting). ANNEX IX REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Regulation (EC) No 91/2003 of the European Parliament and of the Council (OJ L 14, 21.1.2003, p. 1) Commission Regulation (EC) No 1192/2003 (OJ L 167, 4.7.2003, p. 13) Commission Regulation (EC) No 1304/2007 (OJ L 290, 8.11.2007, p. 14) Only Article 3 Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ L 87, 31.3.2009, p. 109) Only point 4.4 of the Annex Regulation (EU) 2016/2032 of the European Parliament and of the Council (OJ L 317, 23.11.2016, p. 105) ANNEX X CORRELATION TABLE Regulation (EC) No 91/2003 This Regulation Articles 1, 2 and 3 Articles 1, 2 and 3 Article 4(1), introductory wording Article 4(1), introductory wording Article 4(1)(a) Article 4(1)(a) Article 4(1)(c) Article 4(1)(b) Article 4(1)(e) Article 4(1)(c) Article 4(1)(f) Article 4(1)(d) Article 4(1)(g) Article 4(1)(e) Article 4(2), (3) and (4) Article 4(2), (3) and (4) Article 4(5) \u2014 Articles 5, 6 and 7 Articles 5, 6 and 7 Article 8(1) Article 8(1) Article 8(1a) Article 8(2) Article 8(2) Article 8(3) Article 8(3) Article 8(4) Article 8(4) Article 8(5) Articles 9, 10 and 11 Articles 9, 10 and 11 \u2014 Article 12 Article 13 Article 13 Annex A Annex I Annex C Annex II Annex E Annex III Annex F Annex IV Annex G Annex V Annex J Annex VI Annex K Annex VII Annex L Annex VIII \u2014 Annex IX \u2014 Annex X", "summary": "EU rail transport statistics EU rail transport statistics SUMMARY OF: Regulation (EU) 2018/643 on rail transport statistics WHAT IS THE AIM OF THE REGULATION? It applies to all railways in the EU. It establishes common rules for producing EU-wide rail transport statistics. It recasts and repeals Regulation (EC) No 91/2003 which had been substantially amended several times. KEY POINTS EU countries: must report statistics for all rail transport on their territory and break these down by country if the service is international; may exclude from the statistics railways which operate within industrial zones or harboursprovide local tourist services, such as historical steam trains; coordinate the data sources used and ensure the quality of the statistics; send the statistics to Eurostat, the EU\u2019s statistical office. The statistics required cover: quarterly and annual data on goods and passengers carried, including per kilometre; an annual breakdown by region every 5 years of goods and passengers transported; traffic flows every 5 years on the number of goods and passenger trains; detailed classification of the different types of goods, including dangerous items. The national information collected by a public or private body may come from: compulsory surveys; administrative or regulatory data; statistical estimation procedures; professional rail organisations; ad hoc studies. Eurostat: sends out the statistics based on the data it receives; develops and publishes methodology to help national authorities collect quality data. The European Commission: presents a report to the European Parliament and the Council by 31 December 2020 \u2014 and then every 4 years \u2014 on the legislation\u2019s implementation; has the renewable 5-year power from 13 December 2016 to use delegated acts, in line with Article 290 of the Treaty on the Functioning of the European Union, to adapt technical definitions in the light of new developments; is assisted by the European Statistical System Committee. FROM WHEN DOES THE REGULATION APPLY? It has applied since 22 May 2018. Regulation (EU) 2018/643 revised and replaced Regulation (EC) No 91/2003 (and its subsequent amendments). BACKGROUND The Commission needs rail statistics to monitor and develop the common transport policy, including trans-European networks, and if necessary, to act to improve rail transport safety. Common concepts and standards ensure national statistics are comparable and help avoid duplication. MAIN DOCUMENT Regulation (EU) 2018/643 of the European Parliament and of the Council of 18 April 2018 on rail transport statistics (recast) (OJ L 112, 2.5.2018, pp. 1-18) RELATED DOCUMENTS Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, pp. 102-149) Successive changes to Directive (EU) 2016/798 have been incorporated into the original document. This consolidated version is of documentary value only. Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, pp. 32-77) See consolidated version. Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, pp. 164-173) See consolidated version. Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community\u2019s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) (OJ L 164, 30.4.2004, pp. 44-113). Text republished in corrigendum (OJ L 220, 21.6.2004, pp. 16-39) See consolidated version. last update 04.03.2019"}
{"article": "7.12.2018 EN Official Journal of the European Union L 312/1 REGULATION (EU) 2018/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 79(2)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) The return of third-country nationals who do not fulfil or no longer fulfil the conditions for entry, stay or residence in the Member States, in full respect of fundamental rights and in particular the principle of non-refoulement, and in accordance with Directive 2008/115/EC of the European Parliament and of the Council (2), is an essential part of the comprehensive efforts to tackle irregular migration and increase the rate of return of irregular migrants. (2) It is necessary to increase the effectiveness of the Union system to return illegally staying third-country nationals. This is essential for maintaining public trust in the Union migration and asylum policy and providing support to persons in need of international protection. (3) Member States should take all necessary measures to return illegally staying third-country nationals in an effective and proportionate manner, in accordance with the provisions of Directive 2008/115/EC. (4) Regulation (EU) 2018/1861 (3) and Regulation (EU) 2018/1862 (4) of the European Parliament and of the Council lay down the conditions for the establishment, operation and use of the Schengen Information System (SIS). (5) A system should be established for sharing information between Member States that use SIS pursuant to Regulation (EU) 2018/1861 concerning return decisions issued in respect of third-country nationals staying illegally on the territory of the Member States and for monitoring whether third-country nationals subject to those decisions have left the territory of the Member States. (6) This Regulation does not affect the rights and obligations of third-country nationals laid down in Directive 2008/115/EC. An alert entered into SIS for the purpose of return does not, in itself, constitute a determination of the status of the third-country national on the territory of Member States, especially in Member States other than the Member State which entered the alert into SIS. (7) Alerts on return entered into SIS and the exchange of supplementary information concerning those alerts should support competent authorities to take the necessary measures to enforce return decisions. SIS should contribute to the identification of and the information sharing between Member States on third-country nationals who are subject to such a return decision, who have absconded and are apprehended in another Member State. Those measures should help prevent and deter irregular migration and secondary movements and enhance cooperation between Member States' authorities. (8) To ensure the effectiveness of return and increase the added value of alerts on return, Member States should enter alerts into SIS in relation to return decisions they issue in respect of illegally staying third-country nationals in accordance with provisions respecting Directive 2008/115/EC. For this purpose, Member States should also enter an alert into SIS when decisions imposing or stating an obligation to return are issued in the situations described in Article 2(2) of that Directive, namely to third-country nationals who are subject to a refusal of entry in accordance with Regulation (EU) 2016/399 of the European Parliament and of the Council (5), or who are apprehended or intercepted by the competent authorities in connection with the irregular crossing by land, sea or air of the external border of a Member State and who have not subsequently obtained an authorisation or a right to stay in that Member State, and to third-country nationals who are subject to return as a criminal law sanction or as a consequence of a criminal law sanction, according to national law, or who are the subject of extradition procedures. In certain circumstances, Member States may refrain from entering alerts on return into SIS where the risk of the return decision not being complied with is low, namely during any period of detention or when the return decision is issued at the external border and is executed immediately, in order to reduce their administrative burden. (9) This Regulation should set out common rules for entering alerts on return into SIS. Alerts on return should be entered into SIS as soon as the underlying return decisions are issued. The alert should indicate whether a period for voluntary departure has been granted to the third-country national concerned, including whether such period has been extended and whether the decision has been suspended or removal has been postponed. (10) It is necessary to determine the categories of data to be entered into SIS in respect of a third-country national who is the subject of a return decision. Alerts on return should contain only those data that are necessary to identify the data subjects, to allow the competent authorities to take informed decisions without losing time and to ensure, where necessary, the protection of those authorities from persons who are, for example, armed, violent, have escaped or are involved in an activity as referred to in Articles 3 to 14 of Directive (EU) 2017/541 of the European Parliament and of the Council (6). Furthermore, in order to facilitate identification and detect multiple identities, the alert should include also a reference to the identification document of the person concerned and a copy of that document, where available. (11) Given the reliability of identifying persons using fingerprints and photographs or facial images, they should always be inserted in alerts on return. As they may not be available, for example, when a return decision is taken in absentia, it should exceptionally be possible to derogate from this requirement in such cases. (12) The exchange of supplementary information provided by the national competent authorities on third-country nationals subject to alerts on return, should always be carried out through the network of national offices called SIRENE Bureaux serving as point of contact and in accordance with Articles 7 and 8 of Regulation (EU) 2018/1861. (13) Procedures should be established to enable Member States to verify that the obligation to return has been complied with and to confirm the departure of the third-country national concerned to the Member State that entered the alert on return into SIS. This information should contribute to more comprehensive monitoring of the compliance with return decisions. (14) Alerts on return should be deleted as soon as the Member State or competent authority that issued the return decision receives confirmation that the return has taken place or where the competent authority has sufficient and convincing information that the third-country national has left the territory of the Member States. Where a return decision is accompanied by an entry ban, an alert for refusal of entry and stay should be entered into SIS in accordance with Regulation (EU) 2018/1861. In such cases Member States should take all necessary measures to ensure that no time-gap exists between the moment in which the third-country national leaves the Schengen area and the activation of the alert for refusal of entry and stay in SIS. If the data contained in SIS show that the return decision is accompanied by an entry ban, the enforcement of the entry ban should be ensured. (15) SIS should contain a mechanism for notifying the Member States of the non-compliance of third-country nationals with an obligation to return within a given period of voluntary departure. The mechanism should support the Member States in fulfilling their obligations to enforce return decisions and their obligations to issue an entry ban in accordance with Directive 2008/115/EC with regard to third-country nationals who have not complied with an obligation to return. (16) This Regulation should establish mandatory rules for consultation between Member States to avoid or reconcile conflicting instructions. Consultations should be carried out where third-country nationals who hold, or are being granted, a valid residence permit or a long-stay visa by a Member State are subject to an alert on return issued by another Member State, in particular if the return decision is accompanied by an entry ban, or where conflicting situations may arise at entry in the territories of the Member States. (17) Alerts should be kept in SIS only for the time required to fulfil the purposes for which they were entered. The relevant provisions of Regulation (EU) 2018/1861 on review periods should apply. Alerts on return should be automatically deleted as soon as they expire, in accordance with the review procedure referred to in that Regulation. (18) Personal data obtained by a Member State pursuant to this Regulation should not be transferred or made available to any third country. As a derogation to that rule, it should be possible to transfer such personal data to a third country where the transfer is subject to strict conditions and is necessary in individual cases in order to assist with the identification of a third-country national for the purposes of his or her return. The transfer of any personal data to third countries should be carried out in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (7) and be conducted with the agreement of the issuing Member State. It should be noted however, that third countries of return are often not subject to adequacy decisions adopted by the Commission under Article 45 of Regulation (EU) 2016/679. Furthermore, the extensive efforts of the Union in cooperating with the main countries of origin of illegally-staying third-country nationals subject to an obligation to return has not been able to ensure the systematic fulfilment by such third countries of the obligation established by international law to readmit their own nationals. Readmission agreements that have been concluded or are being negotiated by the Union or the Member States and which provide for appropriate safeguards for the transfer of data to third countries pursuant to Article 46 of Regulation (EU) 2016/679 cover a limited number of such third countries. Conclusion of any new agreement remains uncertain. In those circumstances, and as an exception to the requirement for an adequacy decision or appropriate safeguards, transfer of personal data to third-country authorities pursuant to this Regulation should be allowed for the purposes of implementing the return policy of the Union. It should be possible to use the derogation provided for in Article 49 of Regulation (EU) 2016/679, subject to the conditions set out in that Article. Under Article 57 of that Regulation, implementation of that Regulation, including with regard to transfers of personal data to third countries pursuant to this Regulation, should be subject to monitoring by independent supervisory authorities. (19) National authorities responsible for return might differ significantly among Member States, and such authorities might also vary within a Member State depending on the reasons for illegal stay. Judicial authorities might also issue return decisions, for instance as result of appeals against a refusal to grant an authorisation or right to stay or as a criminal sanction. All national authorities in charge of issuing and enforcing return decisions in accordance with Directive 2008/115/EC should be entitled to access SIS in order to enter, update, delete and search alerts on return. (20) Access to alerts on return should be granted to the national competent authorities referred to in Regulation (EU) 2018/1861 for the purpose of identification and return of third-country nationals. (21) Regulation (EU) 2016/794 of the European Parliament and of the Council (8) provides that Europol is to support and strengthen actions carried out by the national competent authorities and their cooperation in combating terrorism and serious crime and to provide analysis and threat assessments. In order to facilitate Europol in carrying out its tasks, in particular within the European Migrant Smuggling Centre, it is appropriate to allow Europol access to the category of alerts as provided for in this Regulation. (22) Regulation (EU) 2016/1624 of the European Parliament and of the Council (9) provides, for the purpose of that Regulation, that the host Member State is to authorise the members of the teams referred to in point (8) of Article 2 of that Regulation deployed by the European Border and Coast Guard Agency to consult Union databases where this consultation is necessary for fulfilling operational aims specified in the operational plan on border checks, border surveillance and return. The objective of the deployment of the teams referred to in points (8) and (9) of Article 2 of that Regulation is to provide technical and operational reinforcement to the requesting Member States, especially to those facing disproportionate migratory challenges. For the teams referred to in points (8) and (9) of Article 2 of that Regulation to fulfil their tasks, they require access to alerts on return in SIS through a technical interface of the European Border and Coast Guard Agency connecting to Central SIS. (23) The provisions on responsibilities of the Member States and the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice established by Regulation (EU) 2018/1726 of the European Parliament and of the Council (10) (\u2018eu-LISA\u2019), on the entry and processing of alerts, on the conditions for access to and retention of alerts, on data processing, on data protection, on liability and on monitoring and statistics in Regulation (EU) 2018/1861 should also apply to data contained and processed in SIS in accordance with this Regulation. (24) Since the objectives of this Regulation, namely to establish a system for sharing information about return decisions issued by the Member States in accordance with provisions respecting Directive 2008/115/EC in view of facilitating their enforcement and to monitor the compliance of illegally staying third-country nationals with their obligation to return, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (25) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union. (26) The application of this Regulation is without prejudice to the obligations deriving from the Geneva Convention relating to the Status of Refugees of 28 July 1951, as supplemented by the New York Protocol of 31 January 1967. (27) Member States should implement this Regulation in full respect of fundamental rights, including the respect of the principle of non-refoulement, and should always take into consideration the best interests of the child, family life, and the state of health or condition of vulnerability of the individuals concerned. (28) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark annexed to the TEU and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (29) This Regulation constitutes a development of provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (11); the United Kingdom is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (30) This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (12); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (31) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters' association with the implementation, application and development of the Schengen acquis (13), which fall within the area referred to in Article 1, point (C) of Council Decision 1999/437/EC (14). (32) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (15), which fall within the area referred to in Article 1, point (C) of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (16). (33) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (17), which fall within the area referred to in Article 1, point (C) of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (18). (34) As regards Bulgaria and Romania, this Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 4(2) of the 2005 Act of Accession and should be read in conjunction with Council Decisions 2010/365/EU (19) and (EU) 2018/934 (20). (35) As regards Croatia, this Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 4(2) of the 2011 Act of Accession and should be read in conjunction with Council Decision (EU) 2017/733 (21). (36) Concerning Cyprus this Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 3(2) of the 2003 Act of Accession. (37) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (22) and delivered an opinion on 3 May 2017, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope This Regulation lays down the conditions and procedures for the entry and processing of alerts in respect of third-country nationals subject to return decisions issued by the Member States in the Schengen Information System (SIS) established by Regulation (EU) 2018/1861, as well as for exchanging supplementary information on such alerts. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018return\u2019 means return as defined in point (3) of Article 3 of Directive 2008/115/EC; (2) \u2018third-country national\u2019 means a third-country national as defined in point (1) of Article 3 of Directive 2008/115/EC; (3) \u2018return decision\u2019 means an administrative or judicial decision or act, stating or declaring the stay of a third-country national to be illegal and imposing or stating an obligation to return that respects Directive 2008/115/EC; (4) \u2018alert\u2019 means an alert as defined in point (1) of Article 3 of Regulation (EU) 2018/1861; (5) \u2018supplementary information\u2019 means supplementary information as defined in point (2) of Article 3 of Regulation (EU) 2018/1861; (6) \u2018removal\u2019 means removal as defined in point (5) of Article 3 of Directive 2008/115/EC; (7) \u2018voluntary departure\u2019 means a voluntary departure as defined in point (8) of Article 3 of Directive 2008/115/EC; (8) \u2018issuing Member State\u2019 means an issuing Member State as defined in point (10) of Article 3 of Regulation (EU) 2018/1861; (9) \u2018granting Member State\u2019 means a granting Member State as defined in point (11) of Article 3 of Regulation (EU) 2018/1861; (10) \u2018executing Member State\u2019 means an executing Member State as defined in point (12) of Article 3 of Regulation (EU) 2018/1861; (11) \u2018personal data\u2019 means personal data as defined in point (1) of Article 4 of Regulation (EU) 2016/679; (12) \u2018CS-SIS\u2019 means the technical support function of the Central SIS as referred to in point (a) of Article 4(1) of Regulation (EU) 2018/1861; (13) \u2018residence permit\u2019 means a residence permit as defined in point (16) of Article 2 of Regulation (EU) 2016/399; (14) \u2018long-stay visa\u2019 means a long-stay visa as referred to in Article 18(1) of Convention of 19 June 1990 implementing the Schengen Agreement of 14 June 1985 between the governments of the States of the Benelux Economic Union, the Federal Republic of Germany and the French Republic on the gradual abolition of checks at their common borders (23); (15) a \u2018hit\u2019 means a hit as defined in point (8) of Article 3 of Regulation (EU) 2018/1861; (16) \u2018threat to public health\u2019 means a threat to public health as defined in point (21) of Article 2 of Regulation (EU) 2016/399; (17) \u2018external borders\u2019 means the external borders as defined in point (2) of Article 2 of Regulation (EU) 2016/399. Article 3 Entry of alerts on return into SIS 1. Member States shall enter into SIS alerts on third-country nationals subject to a return decision for the purpose of verifying that the obligation to return has been complied with and of supporting the enforcement of the return decisions. An alert on return shall be entered into SIS without delay following issue of a return decision. 2. Member States may refrain from entering alerts on return when the return decisions concern third-country nationals who are detained pending removal. If the third-country nationals concerned are released from detention without being removed, an alert on return shall be entered into SIS without delay. 3. Member States may refrain from entering alerts on return when the return decision is issued at the external border of a Member State and is executed immediately. 4. The period for voluntary departure granted in accordance with Article 7 of Directive 2008/115/EC shall be recorded in the alert on return immediately. Any extension of that period shall be recorded in the alert without delay. 5. Any suspension or postponement of the enforcement of the return decision, including as a result of the lodging of an appeal, shall immediately be recorded in the alert on return. Article 4 Categories of data 1. An alert on return entered into SIS in accordance with Article 3 of this Regulation shall contain only the following data: (a) surnames; (b) forenames; (c) names at birth; (d) previously used names and aliases; (e) place of birth; (f) date of birth; (g) gender; (h) any nationalities held; (i) whether the person concerned: (i) is armed; (ii) is violent; (iii) has absconded or escaped; (iv) poses a risk of suicide; (v) poses a threat to public health; or (vi) is involved in an activity referred to in Articles 3 to 14 of Directive (EU) 2017/541; (j) the reason for the alert; (k) the authority which created the alert; (l) a reference to the decision giving rise to the alert; (m) the action to be taken in the case of a hit; (n) links to other alerts pursuant to Article 48 of Regulation (EU) 2018/1861; (o) whether the return decision is issued in relation to a third-country national who poses a threat to public policy, to public security or to national security; (p) the type of offence; (q) the category of the person's identification documents; (r) the country of issue of the person's identification documents; (s) the number(s) of the person's identification documents; (t) the date of issue of the person's identification documents; (u) photographs and facial images; (v) dactyloscopic data; (w) a copy of the identification documents, in colour wherever possible; (x) last date of the period for voluntary departure, if granted; (y) whether the return decision has been suspended or the enforcement of the decision has been postponed, including as a result of the lodging of an appeal; (z) whether the return decision is accompanied by an entry ban constituting the basis for an alert for refusal of entry and stay pursuant to point (b) of Article 24(1) of Regulation (EU) 2018/1861. 2. The minimum set of data necessary to enter an alert into SIS shall be the data referred to in points (a), (f), (j), (l), (m), (x) and (z) of paragraph 1. The other data referred to in that paragraph shall also be entered into SIS, if available. 3. Dactyloscopic data referred to in point (v) of paragraph 1 may consist of: (a) one to ten flat fingerprints and one to ten rolled fingerprints of the third-country national concerned; (b) up to two palm prints in respect of third-country nationals from whom the collection of fingerprints is impossible; (c) up to two palm prints in respect of third-country nationals who are subject to return as a criminal law sanction or who have committed a criminal offence on the territory of the Member State which issued the return decision. Article 5 Authority responsible for the exchange of supplementary information The SIRENE Bureau designated under Article 7 of Regulation (EU) 2018/1861 shall ensure the exchange of all supplementary information on third-country nationals who are the subject of an alert on return, in accordance with Articles 7 and 8 of that Regulation. Article 6 Hits at the external borders at exit \u2014 Confirmation of return 1. In the event of a hit on an alert on return concerning a third-country national who is exiting the territory of the Member States through the external border of a Member State, the executing Member State shall communicate the following information to the issuing Member State through the exchange of supplementary information: (a) that the third-country national has been identified; (b) the location and time of the check; (c) that the third-country national has left the territory of the Member States; (d) that the third-country national has been subject to removal, if this is the case. Where a third-country national who is the subject of an alert on return exits the territory of the Member States through the external border of the issuing Member State, the confirmation of return shall be sent to the competent authority of that Member State in accordance with national procedures. 2. The issuing Member State shall delete the alert on return without delay following the receipt of the confirmation of return. Where applicable, an alert for refusal of entry and stay shall be entered without delay pursuant to point (b) of Article 24(1) of Regulation (EU) 2018/1861. 3. The Member States shall on a quarterly basis provide statistics to the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) on the number of confirmed returns and on the number of those confirmed returns where the third-country national was subject to removal. eu-LISA shall compile the quarterly statistics into the annual statistical report referred to in Article 16 of this Regulation. The statistics shall not contain personal data. Article 7 Non-compliance with return decisions 1. Upon expiry of the period for voluntary departure indicated in an alert on return, including any possible extensions, CS-SIS shall automatically notify the issuing Member State. 2. Without prejudice to the procedure referred to in Articles 6(1), 8 and 12, in the event of a hit on an alert on return, the executing Member State shall immediately contact the issuing Member State through the exchange of supplementary information in order to determine the measures to be taken. Article 8 Hits at the external borders upon entry In the event of a hit on an alert on return concerning a third-country national who is entering the territory of the Member States through the external borders, the following shall apply: (a) where the return decision is accompanied by an entry ban, the executing Member State shall immediately inform the issuing Member State through the exchange of supplementary information. The issuing Member State shall immediately delete the alert on return and enter an alert for refusal of entry and stay pursuant to point (b) of Article 24(1) of Regulation (EU) 2018/1861; (b) where the return decision is not accompanied by an entry ban, the executing Member State shall immediately inform the issuing Member State through the exchange of supplementary information, in order that the issuing Member State delete the alert on return without delay. The decision on the entry of the third-country national shall be taken by the executing Member State in accordance with Regulation (EU) 2016/399. Article 9 Prior consultation before granting or extending a residence permit or long-stay visa 1. Where a Member State considers granting or extending a residence permit or long-stay visa to a third-country national who is the subject of an alert on return entered by another Member State that is accompanied by an entry ban, the Member States involved shall consult each other through the exchange of supplementary information, in accordance with the following rules: (a) the granting Member State shall consult the issuing Member State prior to granting or extending the residence permit or long-stay visa; (b) the issuing Member State shall reply to the consultation request within 10 calendar days; (c) the absence of a reply by the deadline referred to in point (b) shall mean that the issuing Member State does not object to the granting or extending of the residence permit or long-stay visa; (d) when making the relevant decision, the granting Member State shall take into account the reasons for the decision of the issuing Member State and shall consider, in accordance with national law, any threat to public policy or to public security which the presence of the third-country national in question on the territory of the Member States may pose; (e) the granting Member State shall notify the issuing Member State of its decision; and (f) where the granting Member State notifies the issuing Member State that it intends to grant or extend the residence permit or long-stay visa or that it has decided to do so, the issuing Member State shall delete the alert on return. The final decision on whether to grant a residence permit or long-stay visa to a third-country national rests with the granting Member State. 2. Where a Member State considers granting or extending a residence permit or long-stay visa to a third-country national who is the subject of an alert on return entered by another Member State which is not accompanied by an entry ban, the granting Member State shall inform without delay the issuing Member State that it intends to grant or has granted a residence permit or a long-stay visa. The issuing Member State shall delete the alert on return without delay. Article 10 Prior consultation before entering an alert on return Where a Member State has issued a return decision in accordance with Article 6(2) of Directive 2008/115/EC and considers entering an alert on return concerning a third-country national who is the holder of a valid residence permit or long-stay visa granted by another Member State, the Member States involved shall consult each other, through the exchange of supplementary information, in accordance with the following rules: (a) the Member State that has taken the return decision shall inform the granting Member State of the decision; (b) the information exchanged under point (a) shall include sufficient detail on the reasons for the return decision; (c) on the basis of the information provided by the Member State that has taken the return decision, the granting Member State shall consider whether there are reasons for withdrawing the residence permit or long-stay visa; (d) when making the relevant decision, the granting Member State shall take into account the reasons for the decision of the Member State that has taken the return decision and shall consider, in accordance with national law, any threat to public policy or to public security which the presence of the third-country national in question on the territory of the Member States may pose; (e) within 14 calendar days of receipt of the request for consultation the granting Member State shall notify the Member State that has taken the return decision of its decision or, where it has been impossible for the granting Member State to take a decision within that period, shall make a reasoned request to extend exceptionally the time period for its response for a maximum of a further 12 calendar days; (f) where the granting Member State notifies the Member State that has taken the return decision that it is maintaining the residence permit or long-stay visa, the Member State that has taken the return decision shall not enter the alert on return. Article 11 A posteriori consultation after entering an alert on return Where it emerges that a Member State has entered an alert on return concerning a third-country national who is the holder of a valid residence permit or long-stay visa granted by another Member State, the issuing Member State may decide to withdraw the return decision. In the case of such withdrawal, it shall immediately delete the alert on return. However, where the issuing Member State decides to maintain the return decision issued in accordance with Article 6(2) of Directive 2008/115/EC, the Member States involved shall consult each other, through the exchange of supplementary information, in accordance with the following rules: (a) the issuing Member State shall inform the granting Member State of the return decision; (b) the information exchanged under point (a) shall include sufficient detail on the reasons for the alert on return; (c) on the basis of the information provided by the issuing Member State, the granting Member State shall consider whether there are reasons for withdrawing the residence permit or long-stay visa; (d) when making its decision, the granting Member State shall take into account the reasons for the decision of the issuing Member State and shall consider, in accordance with national law, any threat to public policy or to public security which the presence of the third-country national in question on the territory of the Member States may pose; (e) within 14 calendar days of receipt of the request for consultation the granting Member State shall notify the issuing Member State of its decision or, where it has been impossible for the granting Member State to take a decision within that period, shall make a reasoned request to extend exceptionally the time period for its response for a maximum of a further 12 calendar days; (f) where the granting Member State notifies the issuing Member State that it is maintaining the residence permit or long-stay visa, the issuing Member State shall immediately delete the alert on return. Article 12 Consultation in the case of a hit concerning a third-country national holding a valid residence permit or long-stay visa Where a Member State encounters a hit on an alert on return entered by a Member State concerning a third-country national who is the holder of a valid residence permit or long-stay visa granted by another Member State, the Member States involved shall consult each other through the exchange of supplementary information, in accordance with the following rules: (a) the executing Member State shall inform the issuing Member State of the situation; (b) the issuing Member State shall initiate the procedure laid down in Article 11; (c) the issuing Member State shall notify the executing Member State of the outcome following the consultation. Article 13 Statistics on exchange of information Member States shall provide statistics to eu-LISA on an annual basis on the exchanges of information carried out in accordance with Articles 8 to 12 and on the instances in which the deadlines provided for in those Articles were not met. Article 14 Deletion of alerts 1. In addition to Articles 6 and 8 to 12, alerts on return shall be deleted when the decision on the basis of which the alert was entered has been withdrawn or annulled by the competent authority. Alerts on return shall also be deleted when the third-country national concerned can demonstrate that he or she has left the territory of the Member States in compliance with the respective return decision. 2. Alerts on return concerning a person who has acquired citizenship of a Member State or of any State whose nationals are beneficiaries of the right of free movement under Union law shall be deleted as soon as the issuing Member State becomes aware, or is so informed pursuant to Article 44 of Regulation (EU) 2018/1861 that the person in question has acquired such citizenship. Article 15 Transfer of personal data to third countries for the purpose of return 1. By way of derogation from Article 50 of Regulation (EU) 2018/1861, the data referred to in points (a), (b), (c), (d), (e), (f), (g), (h), (q), (r), (s), (t), (u), (v) and (w) of Article 4(1) of this Regulation and the related supplementary information may be transferred or made available to a third country with the agreement of the issuing Member State. 2. The transfer of the data to a third country shall be carried out in accordance with the relevant provisions of Union law, in particular provisions on protection of personal data, including Chapter V of Regulation (EU) 2016/679, with readmission agreements where applicable, and with the national law of the Member State transferring the data. 3. The transfers of data to a third country shall take place only when the following conditions are met: (a) the data is transferred or made available solely for the purpose of identification of, and issuance of an identification or travel document to, an illegally staying third-country national in view of his or her return; (b) the third-country national concerned has been informed that his or her personal data and supplementary information may be shared with the authorities of a third country. 4. Transfers of personal data to third countries pursuant to this Article shall not prejudice the rights of applicants for and beneficiaries of international protection, in particular as regards non-refoulement, and the prohibition on disclosing or obtaining information set out in Article 30 of Directive 2013/32/EU of the European Parliament and of the Council (24). 5. Data processed in SIS and the related supplementary information exchanged pursuant to this Regulation shall not be made available to a third country where the enforcement of the return decision was suspended or postponed, including as a result of the lodging of an appeal, on grounds that such return would violate the principle of non-refoulement. 6. Application of Regulation (EU) 2016/679, including with regard to the transfer of personal data to third countries pursuant to this Article, and in particular the use, proportionality and necessity of transfers based on point (d) of Article 49(1) of that Regulation, shall be subject to monitoring by the independent supervisory authorities referred to in Article 51(1) of that Regulation. Article 16 Statistics eu-LISA shall produce daily, monthly and annual statistics, both for each Member State and in aggregate, on the number of alerts on return entered into SIS. The statistics shall include the data referred to in point (y) of Article 4(1), the number of notifications referred to in Article 7(1) and the number of alerts on return that have been deleted. eu-LISA shall produce statistics on the data provided by the Member States in accordance with Article 6(3) and Article 13. The statistics shall not contain any personal data. Those statistics shall be included in the annual statistical report provided for in Article 60(3) of Regulation (EU) 2018/1861. Article 17 Competent authorities having a right to access data in SIS 1. Access to data in SIS and the right to search such data shall be reserved to the national competent authorities referred to in Article 34(1), (2) and (3) of Regulation (EU) 2018/1861. 2. Europol shall within its mandate have the right to access and search data in SIS in accordance with Article 35 of Regulation (EU) 2018/1861 for the purpose of supporting and strengthening action by the competent authorities of the Member States and their mutual cooperation in preventing and combating migrant smuggling and facilitation of irregular migration. 3. Members of the teams referred to in points (8) and (9) of Article 2 of Regulation (EU) 2016/1624 shall within their mandate have the right to access and search data in SIS in accordance with Article 36 of Regulation (EU) 2018/1861 for the purpose of carrying out border checks, border surveillance and return operations through the technical interface set up and maintained by the European Border and Coast Guard Agency. Article 18 Evaluation The Commission shall evaluate the application of this Regulation within two years of the date of the start of its application. This evaluation shall include an assessment of the possible synergies between this Regulation and Regulation (EU) 2017/2226 of the European Parliament and of the Council (25). Article 19 Applicability of the provisions of Regulation (EU) 2018/1861 Insofar as not established in this Regulation, the entry, processing and updating of alerts, the provisions on responsibilities of the Member States and eu-LISA, the conditions concerning access and the review period for alerts, data processing, data protection, liability and monitoring and statistics, as laid down in Articles 6 to 19, Article 20(3) and (4), Articles 21, 23, 32, 33, 34(5) and 38 to 60 of Regulation (EU) 2018/1861, shall apply to data entered and processed in SIS in accordance with this Regulation. Article 20 Entry into force This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. It shall apply from the date set by the Commission in accordance with Article 66(2) of Regulation (EU) 2018/1861. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 28 November 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) Position of the European Parliament of 24 October 2018 (not yet published in the Official Journal) and decision of the Council of 19 November 2018. (2) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (3) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (see page 14 of this Official Journal). (4) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (see page 56 of this Official Journal). (5) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). (6) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, p. 6). (7) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (8) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53). (9) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1). (10) Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, p. 99). (11) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (12) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (13) OJ L 176, 10.7.1999, p. 36. (14) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (15) OJ L 53, 27.2.2008, p. 52. (16) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (17) OJ L 160, 18.6.2011, p. 21. (18) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (19) Council Decision 2010/365/EU of 29 June 2010 on the application of the provisions of the Schengen acquis relating to the Schengen Information System in the Republic of Bulgaria and Romania (OJ L 166, 1.7.2010, p. 17). (20) Council Decision (EU) 2018/934 of 25 June 2018 on the putting into effect of the remaining provisions of the Schengen acquis relating to the Schengen Information System in the Republic of Bulgaria and Romania (OJ L 165, 2.7.2018, p. 37). (21) Council Decision (EU) 2017/733 of 25 April 2017 on the application of the provisions of the Schengen acquis relating to the Schengen Information System in the Republic of Croatia (OJ L 108, 26.4.2017, p. 31). (22) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (23) OJ L 239, 22.9.2000, p. 19. (24) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60). (25) Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing the external borders of the Member States and determining the conditions for access to the EES for law enforcement purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).", "summary": "A strengthened Schengen Information System A strengthened Schengen Information System SUMMARY OF: Regulation (EU) 2018/1860 on the use of the Schengen Information System (SIS) for the return of illegally staying third-country nationals Regulation (EU) 2018/1861 on the establishment, operation and use of the SIS in the field of border checks, and amending the Convention implementing the Schengen Agreement Regulation (EU) 2018/1862 on the establishment, operation and use of the SIS in the field of police cooperation and judicial cooperation in criminal matters WHAT IS THE AIM OF THESE REGULATIONS? The Schengen Information System (SIS), created in 1995 following the abolition of internal border controls in the EU, is a large-scale database supporting external border control and law enforcement cooperation between member countries of the Schengen Agreement. The 3 regulations are designed to strengthen the existing measures in SIS II \u2014 established in 2006 and operational from 2013 \u2014 particularly in light of the new migration and security challenges. They will replace the current legislation laid down in Regulations (EC) No 1986/2006 and (EC) No 1987/2006, and Decision 2007/533/JHA. This summary describes how the SIS will operate once the 3 new regulations are fully in force. KEY POINTS Architecture SIS consists of: a central system (Central SIS) with a technical support function (CS-SIS), containing a database (SIS database) performing technical supervision and administrative tasks, and a backup CS-SIS;a uniform national interface (NI-SIS) in each country which members use to enter, update, delete and search SIS data;a national system (N.SIS) in each country to communicate with Central SIS, including at least one national or shared backup N.SIS. It is not possible to search data files in another N.SIS, unless the countries concerned have agreed to share the file; a communication infrastructure between CS-SIS, backup CS-SIS and NI-SIS provides an encrypted virtual network for SIS data and their exchange between SIRENE bureaux. The European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA): implements technical solutions to strengthen the uninterrupted availability of SIS; in exceptional circumstances, may develop an additional copy of the SIS database; must present a report no later than 28 December 2019 on options for technical solutions, containing an independent impact assessment and cost-benefit analysis; publishes a list of the N.SIS offices and SIRENE Bureaux. Procedural rules state: alerts* should remain in SIS only as long as required for their specific purpose and be deleted when they achieve their purpose; alerts must be reviewed within defined periods. The member country may then decide to prolong them, otherwise they are automatically deleted. The review periods are 5 years: persons wanted for arrest for surrender or extradition purposes and missing persons who may, or may not, need to be placed under protection3 years: people sought to assist with a judicial procedure and unknown wanted persons1 year: children at risk, vulnerable persons who need to be protected from travelling and persons for discreet, inquiry or specific checks10 years: objects for discreet inquiry or specific checks or for seizure or use as evidence in criminal proceedings; categories of data to be entered into the system. These are designed to help end-users take decisions quickly. They include minimum requirements (surname, date of birth, reason for the alert and action to be taken) and other data, such as type of offence, photographic and dactyloscopic* information, if available; use of biometric and dactyloscopic data must respect EU law and fundamental rights, and meet minimum quality standards and technical specifications; a case must be adequate, relevant and sufficiently important to warrant an SIS alert, for example, an alert linked to a terrorist offence meets these criteria; only the issuing member country may modify, add to, correct, update or delete data in SIS; a country which considers acting on an alert would be incompatible with its national law, international obligations or essential interests may attach a flag* to the alert. This indicates it will not take any action on its territory. Costs: the EU budget covers the operational, maintenance and development costs of Central SIS and the communication infrastructure; Schengen member countries cover the operational, maintenance and development costs of their own N.SIS. Alert categories per regulation Regulation (EU) 2018/1860 strengthens enforcement of the EU\u2019s return policy and reduces incentives for illegal immigration into the EU: it lays down common conditions and procedures for entering and processing alerts and exchanging supplementary information on non-EU nationals subject to return decisions*; it requires national authorities to enter alerts as soon as a return decision is taken; it establishes harmonised procedures on categories of data to be included in the alertverification if a return decision has been complied with and, if not, the follow-up between the relevant authoritiesretention and deletion of alerts to ensure there is no delay between the departure of a non-EU national and the activation of an entry bancompulsory consultation between national authorities before granting or extending a residence permit or long-stay visa for a non-EU national who may be the subject of a return alert in another EU countryentering an alert on a return decision if the person is legally staying elsewhere in the EU. Regulation (EU) 2018/1861 covers the use of SIS for entry bans and border checks: it establishes the conditions and procedures for entering and processing alerts and exchange of supplementary information* on non-EU nationals refused entry or the right to stay in the EU; it introduces harmonised procedures on categories of data to be included in the alertcompulsory entry of an alert when a non-EU national is refused entry or the right to stay because they pose a security threat or are subject to a restrictive order preventing entry into, or transit through, an EU countrynon-EU nationals with the right of free movement within the EUmandatory consultation between national authorities before granting or extending a residence permit or long-stay visa to a non-EU national refused the right of entry or stay in another EU country; it guarantees non-EU nationals the right to be informed in writing if they are the subject of an alert. Regulation 2018/1862 improves and extends the use of SIS for cooperation between police and judicial authorities: it establishes the conditions and procedures for entering and processing alerts in the SIS on people and objects, and for exchanging supplementary information and data in police and judicial cooperation on criminal matters; it covers procedures on alerts on: people wanted for arrest, for surrender or extradition purposes;missing persons;vulnerable persons who need to be prevented from travelling, either for their own protection or to prevent a threat to public order or security;children at risk, notably of abduction, trafficking or becoming involved in terrorism;individuals being sought to assist with a judicial procedure as witnesses or because they have been summoned in connection with criminal proceedings;unknown wanted persons whose identity is being sought;discreet or specific checks and inquiries to prevent, detect, investigate or prosecute criminal offences, execute a criminal sentence or prevent threats to public security;items to be seized or used as evidence in criminal proceedings, especially readily identifiable objects such as cars, boats, aircraft, firearms, identity documents and banknotes. Data rightsIndividuals have the right to: know whether or not their personal data are being processed, for what purposes and under what conditions; lodge a complaint with a supervisory authority; correction of inaccurate personal data without undue delay; erasure of personal data if their use is no longer necessary or these have been unlawfully processed; take action to access, rectify, erase, obtain information or compensation for an alert that concerns them; compensation from a member country for any material or non-material damage they suffer from unlawful processing of their personal data. SIS member governments: are committed to enforcing rulings on data protection rights; report annually to the European Data Protection Board on the number of requests they receive to access data and correct inaccuracies, and the volume of court cases and their outcome. Independent supervisory authorities monitor the legality of national processing of personal data in SIS; the European Data Protection Supervisor set up under Regulation (EU) 2018/1725 performs the same role for eu-LISA. The two cooperate to ensure coordinated supervision of SIS. Data processed in SIS and related supplementary information may not be transferred or made available to non-EU countries or international organisations. Regulation (EU) 2018/1725 applies to personal data processed by eu-LISA, the European Border and Coast Guard Agency and Eurojust. Regulation (EU) 2016/679 and Directive (EU) 2016/680 apply to personal data processed by national competent authorities and services. The following have access to data in SIS: National authorities responsible for border control, police and customs checks;prevention, detection, investigation or prosecution of terrorist acts or other serious criminal offences;decisions, including on residence permits and long-stay visas, on the entry, stay and return of non-EU nationals;security checks on non-EU nationals applying for international protection;naturalisation decisions;public prosecutions in criminal proceedings and judicial inquiries;issuing registration certificates for vehicles, boats, aircraft and firearms; the EU agencies below have the right to access and search for the data in SIS they require to carry out their responsibilities. They inform the issuing member country when a search reveals the existence of an alert. They may not connect parts of SIS or transfer any of its data to their own system Europol: may access all data, not just some as previously. SIS member countries must inform the law enforcement agency of any hits or alerts relating to terrorist offences;Eurojust, which handles judicial cooperation of criminal matters;European Border and Coast Guard, teams involved in return-related tasks and migration management support teams. The European Commission evaluates every 5 years the use these agencies make of SIS. ResponsibilitiesEach SIS member country: ensures the data are accurate, up-to-date and entered and stored in SIS lawfully, and respect general data processing rules; sets up, operates, maintains and develops its N.SIS, according to common standards, protocols and technical procedures, and connects it to NI-SIS; ensures the uninterrupted availability of SIS data to end-users; transmits its alerts through its N.SIS; designates an N.SIS Office with central responsibility to ensure the smooth operation and security of its N.SIS, access of the competent authorities to the SIS, overall compliance with the regulation and appropriate availability of the SIS for all end-users; appoints a national authority (the SIRENE Bureau) as a single contact point operational 24/7 for the exchange and availability of all supplementary information on alerts and to facilitate follow-up action; adopts security, business continuity and disaster recovery plans to protect data and prevent unauthorised access; applies professional secrecy and confidentiality rules, including close monitoring of external contractors. Private companies and organisations are banned from operational management of the N.SIS; keeps electronic logs, normally deleted after 3 years, on alerts, access and exchange of personal data to check whether the search was lawful and ensure data integrity and security; operates a national SIS training programme for staff with access to SIS on data security, fundamental rights, including data protection, and data processing rules and regulations. The Commission: adopts implementing and delegated acts on technical aspects of SIS and updates these as necessary; under Regulation (EU) No 1053/2013, has an overall coordinating role for the evaluation and monitoring mechanism it implements with EU governments to ensure Schengen rules are fully applied nationally. This includes evaluation of the SIS; will submit a report to the European Parliament and EU governments by 28 December 2019, and every year thereafter, until decides on the date for SIS operations to start, on the state of play of preparations for full implementation of the updated SIS regulation 2018/1862; carries out an overall evaluation of Central SIS, the supplementary information exchange between national authorities, including an assessment of the automated fingerprint identification system (AFIS) and the SIS information campaigns 3 years after the regulation comes into force and every 4 years thereafter. eu-LISA is responsible for: Central SIS: its operational management, including quality checks on the data it contains, and all the tasks necessary to ensure it functions 24/7 every day of the year; communication infrastructure: key aspects, notably supervision, security, coordination between member countries and providers, and budgetary and contractual issues; SIRENE Bureaux: coordinating, managing and supporting testing activities, maintaining and updating technical specifications on supplementary information exchange between the Bureaux and the communication infrastructure, and managing technical change; adopting the necessary measures to protect data and prevent unauthorised access or use, including security, business continuity and disaster recovery plans for Central SIS and the communication infrastructure; applying professional secrecy and confidentiality rules, and maintenance of electronic logs on the same conditions as national authorities; making publicly available via the EU\u2019s Official Journal a list of national authorities authorised to search for data in SIS; producing daily, monthly and annual statistics on the number of records per category of alerts, omitting any personal data. Its reports are made public. Information campaign The Commission, in cooperation with supervisory authorities and the European Data Protection Supervisor, runs the campaign. This is launched when the legislation comes into force and is repeated at regular intervals, to inform the public on: the aims of SIS;the data it holds;the authorities with access to it;individuals\u2019 data rights. The Commission maintains a publicly available website with all relevant information on SIS. EU countries, working with their supervisory authorities, must inform the public about SIS. FROM WHEN DO THE REGULATIONS APPLY? They shall apply gradually and in entirety they shall be fully operational byno later than 28 December 2021. The date is to be decided by the Commission after the verification that the following conditions have been met: implementing acts have been adopted; national authorities have made the necessary arrangements to process SIS data and the exchange of supplementary information; eu-LISA has successfully completed all its testing requirements. BACKGROUND While based on different pieces of legislation, the SIS is a single system for sharing data and requests among its members. It is the most widely used and largest security and border management information sharing system in Europe. In 2018, it contained some 82.2 million records, had been accessed more than 6.1 billion times and secured 267,239 hits. It operates in 30 European countries: all EU members apart from Cyprus and Ireland, and in Iceland, Liechtenstein, Norway and Switzerland. Communication from the Commission \u2014 COVID-19 Guidance on the implementation of the temporary restriction on non-essential travel to the EU, on the facilitation of transit arrangements for the repatriation of EU citizens, and on the effects on visa policy KEY TERMS Alert: a set of data enabling authorities to identify a person or object and act accordingly. Dactyloscopic data: data on palm and fingerprints. Flag: suspension of the validity of an alert at national level. Return decisions: judicial or administrative decision on a non-EU national considered to be staying illegally who should return to their home country. Supplementary information: information not forming part of the alert data in SIS, but connected to it. MAIN DOCUMENTS Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals(OJ L 312, 7.12.2018, pp. 1-13) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, pp. 14-55) Successive amendments to Regulation (EU) 2018/1861 have been incorporated into the original document. This consolidated version is of documentary value only. Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, pp. 56-106) See consolidated version. RELATED DOCUMENTS Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, pp. 99-137) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, pp. 6-21) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, pp. 1-76) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) See consolidated version. Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, pp. 1-52) See consolidated version. Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, pp. 27-37) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, pp. 98-107) The Schengen acquis as referred to in Article 1(2) of Council Decision 1999/435/EC of 20 May 1999 (OJ L 239, 22.9.2000, pp. 1-473) last update 04.05.2020"}
{"article": "28.11.2018 EN Official Journal of the European Union L 303/39 REGULATION (EU) 2018/1806 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 November 2018 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2)(a) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Council Regulation (EC) No 539/2001 (2) has been substantially amended several times (3). In the interests of clarity and rationality, that Regulation should be codified. (2) This Regulation provides for full harmonisation as regards the third countries whose nationals are subject to a requirement to be in possession of a visa for the crossing of Member States' external borders (also referred to herein as \u2018the visa requirement\u2019) and those whose nationals are exempt from that requirement. (3) The determination of the third countries whose nationals are subject to, or exempt from, the visa requirement should be made on the basis of a considered, case-by-case assessment of a variety of criteria. That assessment should be made periodically and could lead to legislative proposals to amend Annex I to this Regulation, which lists the third countries whose nationals are required to be in possession of a visa when crossing the external borders of the Member States, and Annex II to this Regulation, which lists the third countries whose nationals are exempt from the requirement to be in possession of a visa when crossing the external borders of the Member States for stays of no more than 90 days in any 180-day period, notwithstanding the possibility of having country-specific amendments to those Annexes in particular circumstances, for instance as a result of a visa liberalisation process or as the ultimate consequence of a temporary suspension of the exemption from the visa requirement (also referred to herein as \u2018the visa exemption\u2019). (4) The composition of the lists of third countries in Annexes I and II should be, and should remain, consistent with the criteria set out in this Regulation. References to third countries in respect of which the situation has changed as regards those criteria should be transferred from one Annex to the other. (5) Developments in international law entailing changes in the status or designation of certain States or entities should be reflected in Annexes I and II. (6) As the Agreement on the European Economic Area (4) exempts nationals of Iceland, Liechtenstein and Norway from the visa requirement, those countries should not be included in the list in Annex II. (7) Since the Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other part, on the free movement of persons (5) provides for free movement without visas for nationals of Switzerland and of the Member States, Switzerland should not be included in the list in Annex II. (8) As regards recognised refugees and stateless persons, without prejudice to obligations under international agreements signed by the Member States and in particular the European Agreement on the Abolition of Visas for Refugees of the Council of Europe, signed at Strasbourg on 20 April 1959, the decision as to the visa requirement or exemption should be based on the third country in which those persons reside and which issued their travel documents. However, given the differences in the national law applicable to recognised refugees and to stateless persons, Member States should be able to decide whether those categories of persons should be exempted, where the third country in which those persons reside and which issued their travel documents is a third country whose nationals are exempt from the visa requirement. (9) In accordance with Regulation (EC) No 1931/2006 of the European Parliament and of the Council (6) an exemption from the visa requirement should be laid down for holders of a local border traffic permit. (10) It should be possible for Member States to provide for exemptions from the visa requirement for holders of certain passports other than ordinary passports. (11) In specific cases where special visa rules are warranted, it should be possible for Member States to exempt certain categories of persons from the visa requirement or impose it on them in accordance with public international law or custom. (12) It should be possible for Member States to exempt from the visa requirement recognised refugees, all stateless persons, both those covered by the United Nations Convention relating to the Status of Stateless Persons of 28 September 1954 and those outside of the scope of that Convention, and school pupils travelling on school excursions, where the persons of these categories reside in a third country that is included in the list in Annex II to this Regulation. (13) The arrangements governing exemptions from the visa requirement should fully reflect actual practices. Certain Member States grant exemptions from the visa requirement for nationals of third countries included in the list of third countries whose nationals are required to be in possession of a visa when crossing the external borders of the Member States and who are members of the armed forces travelling on North Atlantic Treaty Organization (NATO) or Partnership for Peace business. For reasons of legal certainty, those exemptions, which are based on international obligations external to Union law, should be referred to in this Regulation. (14) Full visa reciprocity is an objective which the Union should pursue in a proactive manner in its relations with third countries, thus contributing to improving the credibility and consistency of the Union's external policy. (15) Provision should be made for a Union mechanism enabling the principle of reciprocity to be implemented if one of the third countries included in the list in Annex II decides to make the nationals of one or more Member States subject to a visa requirement. That mechanism should provide for a Union response as an act of solidarity, if such a third country applies a visa requirement for nationals of at least one Member State. (16) Upon receipt of a notification from a Member State that a third country included in the list in Annex II applies a visa requirement for nationals of that Member State, all Member States should react in common, thus providing a Union response to a situation which affects the Union as a whole and subjects its citizens to different treatment. (17) In order to ensure the appropriate involvement of the European Parliament and of the Council in the second phase of application of the reciprocity mechanism, given the particularly sensitive political nature of the suspension of the exemption from the visa requirement for all the nationals of a third country included in the list in Annex II and its horizontal implications for the Member States, the Schengen associated countries and the Union itself, in particular for their external relations and for the overall functioning of the Schengen area, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of certain elements of the reciprocity mechanism. Conferring such power on the Commission takes into account the need for political discussion on the Union policy on visas in the Schengen area. It reflects also the need to ensure sufficient transparency and legal certainty in the application of the reciprocity mechanism to all the nationals of the third country concerned, in particular through the corresponding temporary amendment of Annex II to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (7). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (18) This Regulation should provide for a mechanism for the temporary suspension of the exemption from the visa requirement for a third country included in the list in Annex II (\u2018the suspension mechanism\u2019) in an emergency situation, where an urgent response is needed in order to solve the difficulties faced by at least one Member State, and taking the overall impact of the emergency situation on the Union as a whole into account. (19) In order to ensure the efficient application of the suspension mechanism and of certain provisions of the reciprocity mechanism, and in particular in order to allow for all relevant factors and the possible implications of the application of those mechanisms to be adequately taken into account, implementing powers should be conferred on the Commission with regard to the determination of the categories of nationals of the third country concerned who should be subject to a temporary suspension of the exemption from the visa requirement within the framework of the reciprocity mechanism, and of the corresponding duration of that suspension, as well as with regard to the suspension mechanism. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (8). The examination procedure should be used for the adoption of such implementing acts. (20) It is necessary to avoid and counter any abuse resulting from an exemption from the visa requirement for short-stay visits for nationals of a third country where they pose a threat to the public policy (ordre public) and the internal security of the Member State concerned. (21) The suspension mechanism should make it possible for Member States to notify circumstances leading to a possible suspension and for the Commission to trigger the suspension mechanism on its own initiative. (22) In particular, the use of the suspension mechanism should be facilitated by short reference periods and deadlines, allowing for a fast procedure, and the possible grounds of suspension should include a decrease in cooperation on readmission as well as a substantial increase in risks to the public policy or internal security of Member States. That decrease in cooperation should cover a substantial increase in the refusal rate of readmission applications, including for third-country nationals having transited through the third country concerned, where a readmission agreement concluded between the Union or a Member State and that third country provides for such a readmission obligation. The Commission should also be able to trigger the suspension mechanism in the event that the third country fails to cooperate on readmission, in particular where a readmission agreement has been concluded between the third country concerned and the Union. (23) For the purposes of the suspension mechanism, a substantial increase indicates an increase exceeding a threshold of 50 %. It could also indicate a lower increase if the Commission deemed it applicable in the particular case notified by the Member State concerned. (24) For the purposes of the suspension mechanism, a low recognition rate indicates a recognition rate of asylum applications of around 3 or 4 %. It could also indicate a higher recognition rate if the Commission deemed it applicable in the particular case notified by the Member State concerned. (25) It is necessary to avoid and counter any abuse of the visa exemption where it leads to an increase in migratory pressure, resulting from, for example, an increase in unfounded asylum applications, and also when it leads to unfounded applications for residence permits. (26) With a view to ensuring that the specific requirements which were used to assess the appropriateness of a visa exemption, granted as a result of a successful conclusion of a visa liberalisation dialogue, continue to be fulfilled over time, the Commission should monitor the situation in the third countries concerned. The Commission should pay particular attention to the situation of human rights in the third countries concerned. (27) The Commission should report regularly to the European Parliament and to the Council, at least once a year, for a period of seven years after the entry into force of visa liberalisation for a particular third country, and thereafter whenever the Commission considers it necessary, or upon request by the European Parliament or by the Council. (28) The Commission should, before taking any decision to temporarily suspend the visa exemption for nationals of a third country, take into account the situation of human rights in that third country and the possible consequences of a suspension of the visa exemption for that situation. (29) The suspension of the exemption from the visa requirement by an implementing act should cover certain categories of nationals of the third country concerned, by reference to the relevant types of travel documents and, where appropriate, to additional criteria, such as persons travelling for the first time to the territory of the Member States. The implementing act should determine the categories of nationals to which the suspension should apply, taking into account the specific circumstances notified by one or several Member States or reported by the Commission and the principle of proportionality. (30) In order to ensure the appropriate involvement of the European Parliament and of the Council in the implementation of the suspension mechanism, given the politically sensitive nature of a suspension of an exemption from the visa requirement for all nationals of a third country included in the list in Annex II to this Regulation and its horizontal implications for the Member States and the Union itself, in particular for their external relations and for the overall functioning of the Schengen area, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the temporary suspension of the exemption from the visa requirement for the nationals of the third countries concerned. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (31) With a view to ensuring that the visa regime is administered openly and that the persons concerned are informed, Member States should communicate to the Commission and to the other Member States the measures which they take pursuant to this Regulation. For the same reasons, that information should also be published in the Official Journal of the European Union. (32) The conditions governing entry into the territory of the Member States or the issue of visas should not affect the rules governing the recognition of the validity of travel documents. (33) In accordance with the principle of proportionality as set out in Article 5 of the Treaty on European Union, the recourse to a Regulation listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement is both a necessary and an appropriate means of ensuring that the common policy on visas operates efficiently. (34) This Regulation should be without prejudice to the application of international agreements concluded by the European Community before the entry into force of Regulation (EC) No 539/2001 which give rise to the need to derogate from the common policy on visas, while taking into account the case-law of the Court of Justice of the European Union. (35) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters' association with the implementation, application and development of the Schengen acquis (9), which fall within the area referred to in point B of Article 1 of Council Decision 1999/437/EC (10). (36) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement signed between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (11), which fall within the area referred to in points B and C of Article 1 of Decision 1999/437/EC, read in conjunction with Article 3 of Council Decision 2008/146/EC (12). (37) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (13), which fall within the area referred to in points B and C of Article 1 of Decision 1999/437/EC, read in conjunction with Article 3 of Council Decision 2011/350/EU (14). (38) This Regulation constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (15); the United Kingdom is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (39) This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (16); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application, HAVE ADOPTED THIS REGULATION: Article 1 This Regulation determines the third countries whose nationals are subject to, or exempt from, the visa requirement, on the basis of a case-by-case assessment of a variety of criteria relating, inter alia, to illegal immigration, public policy and security, economic benefit, in particular in terms of tourism and foreign trade, and the Union's external relations with the relevant third countries, including, in particular, considerations of human rights and fundamental freedoms, as well as the implications of regional coherence and reciprocity. Article 2 For the purposes of this Regulation, \u2018visa\u2019 means a visa as defined in point (a) of Article 2(2) of Regulation (EC) No 810/2009 of the European Parliament and of the Council (17). Article 3 1. Nationals of third countries listed in Annex I shall be required to be in possession of a visa when crossing the external borders of the Member States. 2. Without prejudice to the requirements stemming from the European Agreement on the Abolition of Visas for Refugees of the Council of Europe signed at Strasbourg on 20 April 1959, recognised refugees and stateless persons shall be required to be in possession of a visa when crossing the external borders of the Member States if the third country where they are resident and which has issued them with their travel document is a third country listed in Annex I to this Regulation. Article 4 1. Nationals of third countries listed in Annex II shall be exempt from the requirement set out in Article 3(1) for stays of no more than 90 days in any 180-day period. 2. The following persons shall also be exempt from the visa requirement: (a) the nationals of third countries listed in Annex I to this Regulation who are holders of a local border traffic permit issued by the Member States pursuant to Regulation (EC) No 1931/2006 when those holders exercise their right within the context of the local border traffic regime; (b) school pupils who are nationals of a third country listed in Annex I to this Regulation, who reside in a Member State applying Council Decision 94/795/JHA (18) and who are travelling in the context of a school excursion as members of a group of school pupils accompanied by a teacher from the school in question; (c) recognised refugees and stateless persons and other persons who do not hold the nationality of any country, who reside in a Member State and who are holders of a travel document issued by that Member State. Article 5 Nationals of new third countries formerly part of third countries listed in Annexes I and II shall be subject respectively to Articles 3 and 4 unless and until the Council decides otherwise under the procedure laid down in the relevant provision of the TFEU. Article 6 1. A Member State may provide for exceptions from the visa requirement provided for in Article 3 or from the exemption from the visa requirement provided for in Article 4 as regards: (a) holders of diplomatic passports, service/official passports or special passports; (b) civilian air and sea crew members in the performance of their duties; (c) civilian sea crew members, when they go ashore, who hold a seafarer's identity document issued in accordance with the International Labour Organisation Conventions No 108 of 13 May 1958 or No 185 of 19 June 2003 or the International Maritime Organization Convention on Facilitation of International Maritime Traffic of 9 April 1965; (d) crew and members of emergency or rescue missions in the event of a disaster or an accident; (e) civilian crew of ships navigating in international inland waters; (f) holders of travel documents issued by intergovernmental international organisations of which at least one Member State is a member, or by other entities recognised by the Member State concerned as subjects of international law, to officials of those organisations or entities. 2. A Member State may exempt from the visa requirement provided for in Article 3: (a) a school pupil having the nationality of a third country listed in Annex I, who resides in a third country listed in Annex II or in Switzerland and Liechtenstein and who is travelling in the context of a school excursion as a member of a group of school pupils accompanied by a teacher from the school in question; (b) recognised refugees and stateless persons if the third country where they reside and which issued their travel document is one of the third countries listed in Annex II; (c) members of the armed forces travelling on NATO or Partnership for Peace business and holders of identification and movement orders provided for by the Agreement between the Parties to the North Atlantic Treaty regarding the Status of their Forces of 19 June 1951; (d) without prejudice to the requirements stemming from the European Agreement on the Abolition of Visas for Refugees of the Council of Europe signed at Strasbourg on 20 April 1959, recognised refugees and stateless persons and other persons who do not hold the nationality of any country who reside in the United Kingdom or in Ireland and are holders of a travel document issued by the United Kingdom or Ireland, which is recognised by the Member State concerned. 3. A Member State may provide for exceptions from the exemption from the visa requirement provided for in Article 4 as regards persons carrying out a paid activity during their stay. Article 7 Where a third country listed in Annex II applies a visa requirement for nationals of at least one Member State, the following provisions shall apply: (a) within 30 days of the implementation by the third country of the visa requirement, the Member State concerned shall notify the European Parliament, the Council and the Commission thereof in writing. That notification shall: (i) specify the date of implementation of the visa requirement and the types of travel documents and visas concerned; (ii) include a detailed explanation of the preliminary measures that the Member State concerned has taken with a view to ensuring visa-free travel with the third country in question and all relevant information. Information relating to that notification shall be published without delay by the Commission in the Official Journal of the European Union, including information on the date of implementation of the visa requirement and the types of travel documents and visas concerned. If the third country decides to lift the visa requirement before the expiry of the deadline referred to in the first subparagraph of this point, the notification shall not be made or shall be withdrawn and the information shall not be published; (b) the Commission shall, immediately following the date of the publication referred to in the third subparagraph of point (a) and in consultation with the Member State concerned, take steps with the authorities of the third country in question, in particular in the political, economic and commercial fields, in order to restore or introduce visa-free travel and shall inform the European Parliament and the Council of those steps without delay; (c) if within 90 days of the date of the publication referred to in the third subparagraph of point (a) and despite all the steps taken in accordance with point (b), the third country has not lifted the visa requirement, the Member State concerned may request the Commission to suspend the exemption from the visa requirement for certain categories of nationals of that third country. Where a Member State makes such a request, it shall inform the European Parliament and the Council thereof; (d) the Commission shall, when considering further steps in accordance with point (e), (f) or (h), take into account the outcome of the measures taken by the Member State concerned with a view to ensuring visa-free travel with the third country in question, the steps taken in accordance with point (b), and the consequences of the suspension of the exemption from the visa requirement for the external relations of the Union and its Member States with the third country in question; (e) if the third country concerned has not lifted the visa requirement, the Commission shall, at the latest within six months of the date of the publication referred to in the third subparagraph of point (a) and subsequently at intervals not exceeding six months within a total period which may not extend beyond the date on which the delegated act referred to in point (f) enters into force or is objected to: (i) adopt, at the request of the Member State concerned or on its own initiative, an implementing act temporarily suspending the exemption from the visa requirement for certain categories of nationals of the third country concerned for a period of up to six months. That implementing act shall fix a date, within 90 days of its entry into force, on which the suspension of the exemption from the visa requirement is to take effect, taking into account the available resources in the consulates of the Member States. When adopting subsequent implementing acts, the Commission may extend the period of that suspension by further periods of up to six months and may modify the categories of nationals of the third country in question for which the exemption from the visa requirement is suspended. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Without prejudice to the application of Article 6, during the periods of suspension all the categories of nationals of the third country referred to in the implementing act shall be required to be in possession of a visa when crossing the external borders of the Member States; or (ii) submit to the committee referred to in Article 11(1) a report assessing the situation and stating the reasons why it decided not to suspend the exemption from the visa requirement and inform the European Parliament and the Council thereof. All relevant factors, such as those referred to in point (d), shall be taken into account in that report. The European Parliament and the Council may have a political discussion on the basis of that report; (f) if within 24 months of the date of the publication referred to in the third subparagraph of point (a), the third country concerned has not lifted the visa requirement, the Commission shall adopt a delegated act in accordance with Article 10 temporarily suspending the exemption from the visa requirement for a period of 12 months for the nationals of that third country. The delegated act shall fix a date, within 90 days of its entry into force, on which the suspension of the exemption from the visa requirement is to take effect, taking into account the available resources in the consulates of the Member States and shall amend Annex II accordingly. That amendment shall be made by inserting next to the name of the third country in question a footnote indicating that the exemption from the visa requirement is suspended with regard to that third country and specifying the period of that suspension. From the date when the suspension of the exemption from the visa requirement for the nationals of the third country concerned takes effect or when an objection to the delegated act is expressed pursuant to Article 10(7), any implementing act adopted pursuant to point (e) of this Article concerning that third country shall expire. Where the Commission submits a legislative proposal as referred to in point (h), the period of suspension of the exemption from the visa requirement referred to in the first subparagraph of this point shall be extended by six months. The footnote referred to in that subparagraph shall be amended accordingly. Without prejudice to the application of Article 6, during the periods of that suspension the nationals of the third country concerned by the delegated act shall be required to be in possession of a visa when crossing the external borders of the Member States; (g) any subsequent notification made by another Member State pursuant to point (a) concerning the same third country during the period of application of measures adopted pursuant to point (e) or (f) with regard to that third country shall be merged into the ongoing procedures without the deadlines or periods set out in those points being extended; (h) if within six months of the entry into force of the delegated act referred to in point (f) the third country in question has not lifted the visa requirement, the Commission may submit a legislative proposal to amend this Regulation in order to transfer the reference to the third country from Annex II to Annex I; (i) the procedures referred to in points (e), (f) and (h) shall not affect the right of the Commission to submit at any time a legislative proposal to amend this Regulation in order to transfer the reference to the third country concerned from Annex II to Annex I; (j) where the third country in question lifts the visa requirement, the Member State concerned shall immediately notify the European Parliament, the Council and the Commission thereof. The notification shall be published without delay by the Commission in the Official Journal of the European Union. Any implementing or delegated act adopted pursuant to point (e) or (f) concerning the third country in question shall expire seven days after the publication referred to in the first subparagraph of this point. Where the third country in question has introduced a visa requirement for nationals of two or more Member States, the implementing or delegated act concerning that third country shall expire seven days after the publication of the notification concerning the last Member State whose nationals were subject to the visa requirement by that third country. The footnote referred to in the first subparagraph of point (f) shall be deleted upon expiry of the delegated act concerned. The information concerning that expiry shall be published without delay by the Commission in the Official Journal of the European Union. Where the third country in question lifts the visa requirement without the Member State concerned notifying it in accordance with the first subparagraph of this point, the Commission shall on its own initiative proceed without delay with the publication referred to in that subparagraph, and the second subparagraph of this point shall apply. Article 8 1. By way of derogation from Article 4, the exemption from the visa requirement for nationals of a third country listed in Annex II shall be temporarily suspended, based on relevant and objective data, in accordance with this Article. 2. A Member State may notify the Commission if it is confronted, over a two-month period, compared with the same period in the preceding year or compared with the last two months prior to the implementation of the exemption from the visa requirement for nationals of a third country listed in Annex II, with one or more of the following circumstances: (a) a substantial increase in the number of nationals of that third country refused entry or found to be staying in the Member State's territory without a right to do so; (b) a substantial increase in the number of asylum applications from the nationals of that third country for which the recognition rate is low; (c) a decrease in cooperation on readmission with that third country, substantiated by adequate data, in particular a substantial increase in the refusal rate of readmission applications submitted by the Member State to that third country for its own nationals or, where a readmission agreement concluded between the Union or that Member State and that third country so provides, for third-country nationals having transited through that third country; (d) an increased risk or imminent threat to the public policy or internal security of Member States, in particular a substantial increase in serious criminal offences, linked to the nationals of that third country, substantiated by objective, concrete and relevant information and data provided by the competent authorities. The notification referred to in the first subparagraph of this paragraph shall state the reasons on which it is based and shall include relevant data and statistics as well as a detailed explanation of the preliminary measures that the Member State concerned has taken with a view to remedying the situation. In its notification, the Member State concerned may specify the categories of nationals of the third country concerned which are to be covered by an implementing act under point (a) of paragraph 6, specifying the detailed reasons for doing so. The Commission shall inform the European Parliament and the Council immediately of such notification. 3. Where the Commission, taking into account the relevant data, reports and statistics, has concrete and reliable information that the circumstances referred to in point (a), (b), (c) or (d) of paragraph 2 are occurring in one or more Member States, or that the third country is not cooperating on readmission, in particular where a readmission agreement has been concluded between that third country and the Union, the Commission shall inform the European Parliament and the Council promptly of its analysis, and the provisions of paragraph 6 shall apply. For the purposes of the first subparagraph, non-cooperation on readmission may consist in, for instance: \u2014 refusing or failing to process readmission applications in due time; \u2014 failing to issue travel documents in due time for the purposes of returning within the deadlines set out in the readmission agreement or refusing to accept European travel documents issued following the expiry of the deadlines set out in the readmission agreement; or \u2014 terminating or suspending the readmission agreement. 4. The Commission shall monitor the continuous compliance with the specific requirements, which are based on Article 1 and which were used to assess the appropriateness of granting visa liberalisation, by the third countries whose nationals have been exempted from the visa requirement when travelling to the territory of Member States as a result of the successful conclusion of a visa liberalisation dialogue conducted between the Union and that third country. In addition, the Commission shall report regularly to the European Parliament and to the Council, at least once a year, for a period of seven years after the date of entry into force of visa liberalisation for that third country, and thereafter whenever the Commission considers it to be necessary, or upon request by the European Parliament or by the Council. The report shall focus on the third countries which the Commission considers, based on concrete and reliable information, are no longer complying with certain requirements. Paragraph 6 shall apply where a report of the Commission shows that one or more of the specific requirements is no longer complied with as regards a particular third country. 5. The Commission shall examine any notification made pursuant to paragraph 2, taking the following into account: (a) whether any of the circumstances referred to in paragraph 2 exist; (b) the number of Member States affected by any of the circumstances referred to in paragraph 2; (c) the overall impact of the circumstances referred to in paragraph 2 on the migratory situation in the Union as it appears from the data provided by the Member States or available to the Commission; (d) the reports prepared by the European Border and Coast Guard, the European Asylum Support Office or the European Union Agency for Law Enforcement Cooperation (Europol) or any other institution, body, office or agency of the Union or international organisation competent in matters covered by this Regulation, if the circumstances so require in the specific case; (e) the information which the Member State concerned may have given in its notification in relation to possible measures under point (a) of paragraph 6; (f) the overall question of public policy and internal security, in consultation with the Member State concerned. The Commission shall inform the European Parliament and the Council of the results of its examination. 6. Where, on the basis of the analysis referred to in paragraph 3, the report referred to in paragraph 4, or the examination referred to in paragraph 5, and taking into account the consequences of a suspension of the exemption from the visa requirement for the external relations of the Union and its Member States with the third country concerned, while working in close cooperation with that third country to find alternative long-term solutions, the Commission decides that action is needed, or where a simple majority of Member States have notified the Commission of the existence of circumstances referred to in point (a), (b), (c) or (d) of paragraph 2, the following provisions shall apply: (a) the Commission shall adopt an implementing act temporarily suspending the exemption from the visa requirement for the nationals of the third country concerned for a period of nine months. The suspension shall apply to certain categories of nationals of the third country concerned, by reference to the relevant types of travel documents and, where appropriate, to additional criteria. When deciding to which categories the suspension is to apply, the Commission shall, based on the information available, include categories that are broad enough in order to efficiently contribute to remedying the circumstances referred to in paragraphs 2, 3 and 4 in each specific case, while respecting the principle of proportionality. The Commission shall adopt the implementing act within one month of: (i) receiving the notification referred to in paragraph 2; (ii) being made aware of the information referred to in paragraph 3; (iii) presenting the report referred to in paragraph 4; or (iv) receiving the notification from a simple majority of Member States of the existence of circumstances referred to in point (a), (b), (c) or (d) of paragraph 2. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 11(2). It shall fix the date on which the suspension of the exemption from the visa requirement is to take effect. During the period of suspension, the Commission shall establish an enhanced dialogue with the third country concerned with a view to remedying the circumstances in question. (b) Where the circumstances referred to in paragraphs 2, 3 and 4 of this Article persist, the Commission shall adopt, at the latest two months before the expiry of the nine-month period referred to in point (a) of this paragraph, a delegated act in accordance with Article 10, temporarily suspending the application of Annex II for a period of 18 months for all nationals of the third country concerned. The delegated act shall take effect from the date of expiry of the implementing act referred to in point (a) of this paragraph and shall amend Annex II accordingly. That amendment shall be made by inserting a footnote next to the name of the third country in question, indicating that the exemption from the visa requirement is suspended with regard to that third country and specifying the period of that suspension. Where the Commission has submitted a legislative proposal pursuant to paragraph 7, the period of suspension of the exemption from the visa requirement provided for in the delegated act shall be extended by six months. The footnote shall be amended accordingly. Without prejudice to the application of Article 6, during the period of suspension, the nationals of the third country concerned shall be required to be in possession of a visa when crossing the external borders of the Member States. A Member State which, in accordance with Article 6, provides for new exemptions from the visa requirement for a category of nationals of the third country covered by the act suspending the exemption from the visa requirement shall communicate those measures in accordance with Article 12. 7. Before the end of the period of validity of the delegated act adopted pursuant to point (b) of paragraph 6, the Commission shall submit a report to the European Parliament and to the Council. The report may be accompanied by a legislative proposal to amend this Regulation in order to transfer the reference to the third country concerned from Annex II to Annex I. 8. Where the Commission has submitted a legislative proposal pursuant to paragraph 7, it may extend the validity of the implementing act adopted pursuant to point (a) of paragraph 6 of this Article by a period not exceeding 12 months. The decision to extend the validity of the implementing act shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 9 1. By 10 January 2018, the Commission shall submit a report to the European Parliament and to the Council assessing the effectiveness of the reciprocity mechanism provided for in Article 7 and shall, if necessary, submit a legislative proposal to amend this Regulation. The European Parliament and the Council shall act on any such proposal in accordance with the ordinary legislative procedure. 2. By 29 March 2021, the Commission shall submit a report to the European Parliament and to the Council assessing the effectiveness of the suspension mechanism provided for in Article 8 and shall, if necessary, submit a legislative proposal to amend this Regulation. The European Parliament and the Council shall act on any such proposal in accordance with the ordinary legislative procedure. Article 10 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in point (f) of Article 7 shall be conferred on the Commission for a period of five years from 9 January 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The power to adopt delegated acts referred to in point (b) of Article 8(6) shall be conferred on the Commission for a period of five years from 28 March 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 4. The delegation of power referred to in point (f) of Article 7 and in point (b) of Article 8(6) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 6. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 7. A delegated act adopted pursuant to point (f) of Article 7 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of four months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. 8. A delegated act adopted pursuant to point (b) of Article 8(6) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. Article 11 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 12 1. Member States shall communicate to the other Member States and the Commission the measures they take pursuant to Article 6, within five working days of the adoption of those measures. 2. The Commission shall publish the measures communicated pursuant to paragraph 1 in the Official Journal of the European Union for information. Article 13 This Regulation shall not affect the competence of Member States with regard to the recognition of States and territorial units and passports, travel and identity documents issued by their authorities. Article 14 Regulation (EC) No 539/2001 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IV. Article 15 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 14 November 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) Position of the European Parliament of 2 October 2018 (not yet published in the Official Journal) and decision of the Council of 6 November 2018. (2) Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (OJ L 81, 21.3.2001, p. 1). (3) See Annex III. (4) OJ L 1, 3.1.1994, p. 3. (5) OJ L 114, 30.4.2002, p. 6. (6) Regulation (EC) No 1931/2006 of the European Parliament and of the Council of 20 December 2006 laying down rules on local border traffic at the external land borders of the Member States and amending the provisions of the Schengen Convention (OJ L 405, 30.12.2006, p. 1). (7) OJ L 123, 12.5.2016, p. 1. (8) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (9) OJ L 176, 10.7.1999, p. 36. (10) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (11) OJ L 53, 27.2.2008, p. 52. (12) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (13) OJ L 160, 18.6.2011, p. 21. (14) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (15) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (16) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (17) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1). (18) Council Decision 94/795/JHA of 30 November 1994 on a joint action adopted by the Council on the basis of Article K.3.2.b of the Treaty on European Union concerning travel facilities for school pupils from third countries resident in a Member State (OJ L 327, 19.12.1994, p. 1). ANNEX I LIST OF THIRD COUNTRIES WHOSE NATIONALS ARE REQUIRED TO BE IN POSSESSION OF A VISA WHEN CROSSING THE EXTERNAL BORDERS OF THE MEMBER STATES 1. STATES Afghanistan Armenia Angola Azerbaijan Bangladesh Burkina Faso Bahrain Burundi Benin Bolivia Bhutan Botswana Belarus Belize Democratic Republic of the Congo Central African Republic Congo C\u00f4te d'Ivoire Cameroon China Cuba Cape Verde Djibouti Dominican Republic Algeria Ecuador Egypt Eritrea Eswatini Ethiopia Fiji Gabon Ghana The Gambia Guinea Equatorial Guinea Guinea-Bissau Guyana Haiti Indonesia India Iraq Iran Jamaica Jordan Kenya Kyrgyzstan Cambodia Comoros North Korea Kuwait Kazakhstan Laos Lebanon Sri Lanka Liberia Lesotho Libya Morocco Madagascar Mali Myanmar/Burma Mongolia Mauritania Maldives Malawi Mozambique Namibia Niger Nigeria Nepal Oman Papua New Guinea Philippines Pakistan Qatar Russia Rwanda Saudi Arabia Sudan Sierra Leone Senegal Somalia Suriname South Sudan S\u00e3o Tom\u00e9 and Pr\u00edncipe Syria Chad Togo Thailand Tajikistan Turkmenistan Tunisia Turkey Tanzania Uganda Uzbekistan Vietnam Yemen South Africa Zambia Zimbabwe 2. ENTITIES AND TERRITORIAL AUTHORITIES THAT ARE NOT RECOGNISED AS STATES BY AT LEAST ONE MEMBER STATE \u2014 Kosovo as defined by the United Nations Security Council Resolution 1244 of 10 June 1999 \u2014 The Palestinian Authority ANNEX II LIST OF THIRD COUNTRIES WHOSE NATIONALS ARE EXEMPT FROM THE REQUIREMENT TO BE IN POSSESSION OF A VISA WHEN CROSSING THE EXTERNAL BORDERS OF THE MEMBER STATES FOR STAYS OF NO MORE THAN 90 DAYS IN ANY 180-DAY PERIOD 1. STATES former Yugoslav Republic of Macedonia (1) Andorra United Arab Emirates (2) Antigua and Barbuda Albania (1) Argentina Australia Bosnia and Herzegovina (1) Barbados Brunei Brazil Bahamas Canada Chile Colombia Costa Rica Dominica (2) Micronesia (2) Grenada (2) Georgia (3) Guatemala Honduras Israel Japan Kiribati (2) Saint Kitts and Nevis South Korea Saint Lucia (2) Monaco Moldova (4) Montenegro (5) Marshall Islands (6) Mauritius Mexico Malaysia Nicaragua Nauru (6) New Zealand Panama Peru (6) Palau (6) Paraguay Serbia (excluding holders of Serbian passports issued by the Serbian Coordination Directorate (in Serbian: Koordinaciona uprava)) (5) Solomon Islands Seychelles Singapore San Marino El Salvador Timor-Leste (6) Tonga (6) Trinidad and Tobago Tuvalu (6) Ukraine (7) United States Uruguay Holy See Saint Vincent and the Grenadines (6) Venezuela Vanuatu (6) Samoa 2. SPECIAL ADMINISTRATIVE REGIONS OF THE PEOPLE'S REPUBLIC OF CHINA Hong Kong SAR (8) Macao SAR (9) 3. BRITISH CITIZENS WHO ARE NOT NATIONALS OF THE UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND FOR THE PURPOSES OF UNION LAW British nationals (Overseas) British overseas territories citizens (BOTC) British overseas citizens (BOC) British protected persons (BPP) British subjects (BS) 4. ENTITIES AND TERRITORIAL AUTHORITIES THAT ARE NOT RECOGNISED AS STATES BY AT LEAST ONE MEMBER STATE Taiwan (10) (1) The exemption from the visa requirement shall only apply to holders of biometric passports. (2) The exemption from the visa requirement shall apply from the date of entry into force of an agreement on visa exemption to be concluded with the European Union. (3) The exemption from the visa requirement shall be limited to the holders of biometric passports issued by Georgia in line with standards of the International Civil Aviation Organisation (ICAO). (4) The exemption from the visa requirement shall be limited to the holders of biometric passports issued by Moldova in line with standards of the International Civil Aviation Organisation (ICAO). (5) The exemption from the visa requirement shall only apply to holders of biometric passports. (6) The exemption from the visa requirement shall apply from the date of entry into force of an agreement on visa exemption to be concluded with the European Union. (7) The exemption from the visa requirement shall be limited to the holders of biometric passports issued by Ukraine in line with standards of the International Civil Aviation Organisation (ICAO). (8) The exemption from the visa requirement shall only apply to holders of a \u2018Hong Kong Special Administrative Region\u2019 passport. (9) The exemption from the visa requirement shall only apply to holders of a \u2018Regi\u00e3o Administrativa Especial de Macau\u2019 passport. (10) The exemption from the visa requirement shall only apply to holders of passports issued by Taiwan which include an identity card number. ANNEX III REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Council Regulation (EC) No 539/2001 (OJ L 81, 21.3.2001, p. 1) Council Regulation (EC) No 2414/2001 (OJ L 327, 12.12.2001, p. 1) Council Regulation (EC) No 453/2003 (OJ L 69, 13.3.2003, p. 10) Act of Accession of 2003, Annex II, point 18(B) Council Regulation (EC) No 851/2005 (OJ L 141, 4.6.2005, p. 3) Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1) Only the eleventh indent of Article 1(1) as regards Regulation (EC) No 539/2001, and point 11(B)(3) of the Annex Council Regulation (EC) No 1932/2006 (OJ L 405, 30.12.2006, p. 23) Council Regulation (EC) No 1244/2009 (OJ L 336, 18.12.2009, p. 1) Regulation (EU) No 1091/2010 of the European Parliament and of the Council (OJ L 329, 14.12.2010, p. 1) Regulation (EU) No 1211/2010 of the European Parliament and of the Council (OJ L 339, 22.12.2010, p. 6) Council Regulation (EU) No 517/2013 (OJ L 158, 10.6.2013, p. 1) Only the fourth indent of Article 1(1)(k) and point 13(B)(2) of the Annex Regulation (EU) No 610/2013 of the European Parliament and of the Council (OJ L 182, 29.6.2013, p. 1) Only Article 4 Regulation (EU) No 1289/2013 of the European Parliament and of the Council (OJ L 347, 20.12.2013, p. 74) Regulation (EU) No 259/2014 of the European Parliament and of the Council (OJ L 105, 8.4.2014, p. 9) Regulation (EU) No 509/2014 of the European Parliament and of the Council (OJ L 149, 20.5.2014, p. 67) Regulation (EU) 2017/371 of the European Parliament and of the Council (OJ L 61, 8.3.2017, p. 1) Regulation (EU) 2017/372 of the European Parliament and of the Council (OJ L 61, 8.3.2017, p. 7) Regulation (EU) 2017/850 of the European Parliament and of the Council (OJ L 133, 22.5.2017, p. 1) ANNEX IV CORRELATION TABLE Regulation (EC) No 539/2001 This Regulation Article -1 Article 1 Article 1(1), first subparagraph Article 3(1) Article 1(1), second subparagraph Article 3(2) Article 1(2), first subparagraph Article 4(1) Article 1(2), second subparagraph, introductory wording Article 4(2), introductory wording Article 1(2), second subparagraph, first indent Article 4(2)(a) Article 1(2), second subparagraph, second indent Article 4(2)(b) Article 1(2), second subparagraph, third indent Article 4(2)(c) Article 1(3) Article 5 Article 1(4) Article 7 Article 1a(1) and (2) Article 8(1) and (2) Article 1a(2a) Article 8(3) Article 1a(2b) Article 8(4) Article 1a(3) Article 8(5) Article 1a(4) Article 8(6) Article 1a(5) Article 8(7) Article 1a(6) Article 8(8) Article 1b Article 9(1) Article 1c Article 9(2) Article 2 Article 2 Article 4 Article 6 Article 4a Article 11 Article 4b(1) and (2) Article 10(1) and (2) Article 4b(2a) Article 10(3) Article 4b(3) Article 10(4) Article 4b(3a) Article 10(5) Article 4b(4) Article 10(6) Article 4b(5) Article 10(7) Article 4b(6) Article 10(8) Article 5 Article 12 Article 6 Article 13 Article 7 Article 14 Article 8 Article 15 Annex I Annex I Annex II Annex II \u2014 Annex III \u2014 Annex IV", "summary": "Visa requirements for non-EU nationals Visa requirements for non-EU nationals SUMMARY OF: Regulation (EU) 2018/1806 \u2014 list of non-EU countries whose nationals must be in possession of visas when entering the EU and those whose nationals are exempt from that requirement WHAT IS THE AIM OF THIS REGULATION? It lists the countries covered by this legislation and those that are exempt. The regulation repeals and codifies the much-amended Regulation (EC) No 539/2001. KEY POINTS The regulation develops from the Schengen Agreement and Convention in which neither the United Kingdom (1) nor Ireland take part, and are therefore not bound by it or subject to its application. The regulation lists, in its annex: the non-EU countries and territories whose nationals must hold a visa; and those countries and territories whose nationals are exempt from the visa requirements when entering the EU for stays of up to 90 days in any 180-day period. The regulation also allows for: exceptions: the possibility for EU countries to grant exceptions to the visa requirement for certain categories of persons such as holders of diplomatic or service passports, civilian air and sea crews, school pupils in groups, holders of local traffic permits, and exemptions for recognised refugees and stateless persons who live in the EU and hold a travel document issued by their country of residence; reciprocity: a mechanism allowing reciprocity if any visa-exempt non-EU country decides to impose a visa requirement on any EU country; temporary suspension: a mechanism for the temporary suspension of visa exemptions in an emergency situation such as a substantial increase of migratory or security risk. Decisions to amend the lists are on a case-by-case basis considering criteria including: illegal immigration, public policy and security; economic benefit, in particular in terms of tourism and foreign trade; the EU\u2019s external relations with the relevant non-EU country, in particular relating to human rights and fundamental freedoms, regional coherence and reciprocity. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 18 December 2018. The Regulation (EU) 2018/1806 codifies and replaces Regulation (EC) No 539/2001 and its subsequent amendments. BACKGROUND See also: Visa policy (European Commission). MAIN DOCUMENT Regulation (EU) 2018/1806 of the European Parliament and of the Council of 14 November 2018 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification) (OJ L 303, 28.11.2018, pp. 39-58) RELATED DOCUMENTS Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, pp. 19-20) Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (OJ L 160, 18.6.2011, pp. 21-36) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, pp. 1-58) Successive amendments to Regulation (EC) No 810/2009 have been incorporated into the original document. This consolidated version is of documentary value only. Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, pp. 1-2) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland\u2019s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, pp. 20-23) Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (OJ L 81, 21.3.2001, pp.1-7) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, pp. 43-47) See consolidated version. Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, pp. 31-33) last update 07.03.2019(1) The United Kingdom withdraws from the European Union and becomes a third country (non-EU country) as of 1 February 2020."}
{"article": "21.11.2018 EN Official Journal of the European Union L 295/138 REGULATION (EU) 2018/1727 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 85 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Eurojust was set up by Council Decision 2002/187/JHA (2) as a Union body with legal personality, to stimulate and to improve coordination and cooperation between competent judicial authorities of the Member States, particularly in relation to serious organised crime. Eurojust\u2019s legal framework has been amended by Council Decisions 2003/659/JHA (3) and 2009/426/JHA (4). (2) Article 85 of the Treaty on the Functioning of the European Union (TFEU) provides for Eurojust to be governed by a regulation, adopted in accordance with the ordinary legislative procedure. It also requires determining arrangements for involving the European Parliament and national parliaments in the evaluation of Eurojust\u2019s activities. (3) Article 85 TFEU also provides that Eurojust\u2019s mission is to support and strengthen coordination and cooperation between national investigating and prosecuting authorities in relation to serious crime affecting two or more Member States or requiring prosecution on common bases, on the basis of operations conducted and information supplied by the Member States\u2019 authorities and by the European Union Agency for Law Enforcement Cooperation (Europol). (4) This Regulation aims to amend and expand the provisions of Decision 2002/187/JHA. Since the amendments to be made are of substantial number and nature, Decision 2002/187/JHA should in the interests of clarity be replaced in its entirety in relation to the Member States bound by this Regulation. (5) As the European Public Prosecutor\u2019s Office (EPPO) has been established by means of enhanced cooperation, Council Regulation (EU) 2017/1939 (5) is binding in its entirety and directly applicable only to Member States that participate in enhanced cooperation. Therefore, for those Member States which do not participate in the EPPO, Eurojust remains fully competent for forms of serious crime listed in Annex I to this Regulation. (6) Article 4(3) of the Treaty on European Union (TEU) recalls the principle of sincere cooperation by virtue of which the Union and the Member States are, in full mutual respect, to assist each other in carrying out tasks which flow from the TEU and the TFEU. (7) In order to facilitate cooperation between Eurojust and the EPPO, Eurojust should address issues of relevance to the EPPO whenever necessary. (8) In light of the establishment of the EPPO by means of enhanced cooperation, the division of competences between the EPPO and Eurojust with respect to crimes affecting the financial interests of the Union needs to be clearly established. From the date on which the EPPO assumes its tasks, Eurojust should be able to exercise its competence in cases which concern crimes for which the EPPO is competent, where those crimes involve both Member States which participate in enhanced cooperation on the establishment of the EPPO and Member States which do not participate in such enhanced cooperation. In such cases, Eurojust should act at the request of the non-participating Member States or at the request of the EPPO. Eurojust should in any case remain competent for offences affecting the financial interests of the Union whenever the EPPO is not competent or where, although the EPPO is competent, it does not exercise its competence. The Members States which do not participate in enhanced cooperation on the establishment of the EPPO may continue to request Eurojust\u2019s support in all cases regarding offences affecting the financial interests of the Union. The EPPO and Eurojust should develop close operational cooperation in line with their respective mandates. (9) In order for Eurojust to fulfil its mission and develop its full potential in the fight against serious cross-border crime, its operational functions should be strengthened by reducing the administrative workload of national members, and its European dimension enhanced through the Commission\u2019s participation in the Executive Board and the increased involvement of the European Parliament and national parliaments in the evaluation of its activities. (10) Therefore, this Regulation should determine the arrangements for parliamentary involvement, modernising Eurojust\u2019s structure and simplifying its current legal framework, while maintaining those elements that have proven to be efficient in its operation. (11) The forms of serious crime affecting two or more Member States for which Eurojust is competent should be clearly laid down. In addition, cases which do not involve two or more Member States, but which require a prosecution on common bases, should be defined. Such cases may include investigations and prosecutions affecting only one Member State and a third country where an agreement has been concluded with that third country or where there may be a specific need for Eurojust\u2019s involvement. Such prosecution may also refer to cases which affect one Member State and have repercussions at Union level. (12) When exercising its operational functions in relation to concrete criminal cases, at the request of the competent authorities of Member States or on its own initiative, Eurojust should act either through one or more of the national members or as a College. By acting on its own initiative, Eurojust may take a more proactive role in coordinating cases, such as by supporting the national authorities in their investigations and prosecutions. This may include involving Member States that might not initially have been included in the case and discovering links between cases based on the information it receives from Europol, the European Anti-Fraud Office (OLAF), the EPPO and national authorities. This also allows Eurojust to produce guidelines, policy documents and casework-related analyses as part of its strategic work. (13) At the request of a Member State\u2019s competent authority or of the Commission, it should also be possible for Eurojust to assist with investigations involving only that Member State but which have repercussions at Union level. Examples of such investigations include cases where a member of a Union institution or body is involved. Such investigations also cover cases which involve a significant number of Member States and could potentially require a coordinated European response. (14) The written opinions of Eurojust are not binding on Member States, but should be responded to in accordance with this Regulation. (15) To ensure Eurojust can support and coordinate cross-border investigations appropriately, it is necessary that all national members have the necessary operational powers with respect to their Member State and in accordance with the law of that Member State in order to cooperate between themselves and with national authorities in a more coherent and effective way. National members should be granted those powers that allow Eurojust to appropriately achieve its mission. Those powers should include accessing relevant information in national public registers, directly contacting and exchanging information with competent authorities and participating in joint investigation teams. National members may, in accordance with their national law, retain the powers which are derived from their capacity as national authorities. In agreement with the competent national authority or in urgent cases, national members may also order investigative measures and controlled deliveries, and issue and execute requests for mutual legal assistance or mutual recognition. Since those powers are to be exercised in accordance with national law, the courts of Member States should be competent to review those measures, in accordance with the requirements and procedures laid down by national law. (16) It is necessary to provide Eurojust with an administrative and management structure that allows it to perform its tasks more effectively, complies with the principles applicable to Union agencies, and fully respects fundamental rights and freedoms, while maintaining Eurojust\u2019s special characteristics and safeguarding its independence in the exercise of its operational functions. To that end, the functions of the national members, the College and the Administrative Director should be clarified and an Executive Board established. (17) Provisions should be laid down to clearly distinguish between the operational and the management functions of the College, thus reducing the administrative burden on national members to a minimum so that the focus is put on Eurojust\u2019s operational work. The management tasks of the College should include in particular the adoption of Eurojust\u2019s work programmes, budget, annual activity report, and working arrangements with partners. The College should exercise the power of appointing authority with respect to the Administrative Director. The College should also adopt Eurojust\u2019s rules of procedure. Since those rules of procedure may have an impact on the judicial activities of the Member States, implementing powers should be conferred on the Council to approve those rules. (18) To improve Eurojust\u2019s governance and streamline procedures, an Executive Board should be established to assist the College in its management functions and to allow for streamlined decision-making on non-operational and strategic issues. (19) The Commission should be represented in the College when the College exercises its management functions. The Commission\u2019s representative in the College should be also its representative on the Executive Board, to ensure non-operational supervision of Eurojust and to provide it with strategic guidance. (20) In order to ensure the efficient day-to-day administration of Eurojust, the Administrative Director should be its legal representative and manager, accountable to the College. The Administrative Director should prepare and implement the decisions of the College and the Executive Board. The Administrative Director should be appointed on the basis of merit, and of his or her documented administrative and managerial skills, as well as relevant competence and experience. (21) A President and two Vice-Presidents of Eurojust should be elected by the College from among the national members for a term of office of four years. When a national member is elected President, the Member State concerned should be able to second another suitably qualified person to the national desk and to apply for compensation from Eurojust\u2019s budget. (22) Suitably qualified persons are persons who have the necessary qualifications and experience to perform the tasks required to ensure that the national desk functions effectively. They may have the status of a deputy or Assistant to the national member who has been elected President or they may have a more administrative or technical function. Each Member State should be able to decide on its own requirements in this regard. (23) Quorum and voting procedures should be regulated in Eurojust\u2019s rules of procedure. In exceptional cases, where a national member and his or her deputy are absent, the Assistant of the national member concerned should be entitled to vote in the College if the Assistant has the status of a magistrate, i.e. a prosecutor, judge or representative of a judicial authority. (24) Since the compensation mechanism has a budgetary impact, this Regulation should confer implementing powers to determine that mechanism on the Council. (25) The setting up of an on-call coordination mechanism within Eurojust is necessary to make Eurojust more efficient and enable it to be available around the clock to intervene in urgent cases. Each Member State should ensure that their representatives in the on-call coordination mechanism are available to act 24 hours a day, seven days a week. (26) Eurojust national coordination systems should be set up in the Member States to coordinate the work carried out by the national correspondents for Eurojust, the national correspondent for terrorism matters, any national correspondent for issues relating to the competence of the EPPO, the national correspondent for the European Judicial Network and up to three other contact points, as well as representatives in the network for joint investigation teams and representatives in the networks set up by Council Decisions 2002/494/JHA (6), 2007/845/JHA (7) and 2008/852/JHA (8). Member States may decide that one or more of those tasks are to be performed by the same national correspondent. (27) For the purposes of stimulating and strengthening coordination and cooperation between national investigating and prosecuting authorities, it is crucial that Eurojust receive information from national authorities that is necessary for the performance of its tasks. To that end, competent national authorities should inform their national members of the setting up and results of joint investigation teams without undue delay. Competent national authorities should also inform national members without undue delay of cases falling under the competence of Eurojust that directly involve at least three Member States and for which requests or decisions on judicial cooperation have been transmitted to at least two Member States. Under certain circumstances, they should also inform national members of conflicts of jurisdiction, controlled deliveries and repeated difficulties in judicial cooperation. (28) Directive (EU) 2016/680 of the European Parliament and of the Council (9) sets out harmonised rules for the protection and the free movement of personal data processed for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security. In order to ensure the same level of protection for natural persons through legally enforceable rights throughout the Union and to prevent divergences hampering the exchange of personal data between Eurojust and competent authorities in Member States, the rules for the protection and the free movement of operational personal data processed by Eurojust should be consistent with Directive (EU) 2016/680. (29) The general rules of the distinct Chapter of Regulation (EU) 2018/1725 of the European Parliament and of the Council (10) on the processing of operational personal data should apply without prejudice to the specific data protection rules of this Regulation. Such specific rules should be regarded as lex specialis to the provisions in that Chapter of Regulation (EU) 2018/1725 (lex specialis derogat legi generali). In order to reduce legal fragmentation, specific data protection rules in this Regulation should be consistent with the principles underpinning that Chapter of Regulation (EU) 2018/1725, as well as with the provisions of that Regulation relating to independent supervision, remedies, liability and penalties. (30) The protection of the rights and freedoms of data subjects requires a clear attribution of responsibilities for data protection under this Regulation. Member States should be responsible for the accuracy of data they have transmitted to Eurojust and which have been processed unaltered by Eurojust, for keeping such data up to date and for the legality of transmitting those data to Eurojust. Eurojust should be responsible for the accuracy of data provided by other data suppliers or resulting from Eurojust\u2019s own analyses or data collection and for keeping such data up to date. Eurojust should ensure that data are processed fairly and lawfully, and are collected and processed for a specific purpose. Eurojust should also ensure that the data are adequate, relevant, not excessive in relation to the purpose for which they are processed, stored no longer than is necessary for that purpose, and processed in a manner that ensures appropriate security of personal data and confidentiality of data processing. (31) Appropriate safeguards for the storage of operational personal data for archiving purposes in the public interest or statistical purposes should be included in Eurojust\u2019s rules of procedure. (32) A data subject should be able to exercise the right of access referred to in Regulation (EU) 2018/1725 to operational personal data relating to him or her which are processed by Eurojust. The data subject may make such a request at reasonable intervals, free of charge, to Eurojust or to the national supervisory authority in the Member State of the data subject\u2019s choice. (33) The data protection provisions of this Regulation are without prejudice to the applicable rules on the admissibility of personal data as evidence in criminal pre-trial and court proceedings. (34) All processing of personal data by Eurojust, within the framework of its competence, for the fulfilment of its tasks should be considered as processing of operational personal data. (35) As Eurojust also processes administrative personal data unrelated to criminal investigations, the processing of such data should be subject to the general rules of Regulation (EU) 2018/1725. (36) Where operational personal data are transmitted or supplied to Eurojust by the Member State, the competent authority, the national member or the national correspondent for Eurojust should have the right to request rectification or erasure of those operational personal data. (37) In order to demonstrate compliance with this Regulation, Eurojust or the authorised processor should maintain records regarding all categories of processing activities under its responsibility. Eurojust and each authorised processor should be obliged to cooperate with the European Data Protection Supervisor (the \u2018EDPS\u2019) and to make those records available to it on request, so that they might serve for monitoring those processing operations. Eurojust or its authorised processor, when processing personal data in non-automated processing systems, should have in place effective methods of demonstrating the lawfulness of the processing, of enabling self-monitoring and of ensuring data integrity and data security, such as logs or other forms of records. (38) The Executive Board of Eurojust should designate a Data Protection Officer who should be a member of the existing staff. The person designated as Data Protection Officer of Eurojust should have received specialised training in data protection law and practice for acquiring expert knowledge in that field. The necessary level of expert knowledge should be determined in relation to the data processing carried out and the protection required for the personal data processed by Eurojust. (39) The EDPS should be responsible for monitoring and ensuring the complete application of the data protection provisions of this Regulation with regard to processing of operational personal data by Eurojust. The EDPS should be granted powers allowing him or her to fulfil this duty effectively. The EDPS should have the right to consult Eurojust regarding submitted requests, to refer matters to Eurojust for the purpose of addressing concerns that have emerged regarding its processing of operational personal data, to make proposals for improving the protection of the data subjects, and to order Eurojust to carry out specific operations with regard to processing of operational personal data. As a result, the EDPS requires the means to have the orders complied with and executed. He or she should therefore also have the power to warn Eurojust. To warn means to issue an oral or written reminder of Eurojust\u2019s obligation to execute the EDPS\u2019 orders or to comply with the proposals of the EDPS and a reminder of the measures to be applied upon any non-compliance or refusal by Eurojust. (40) The duties and powers of the EDPS, including the power to order Eurojust to carry out the rectification, restriction of processing or erasure of operational personal data which have been processed in breach of the data protection provisions contained in this Regulation, should not extend to the personal data contained in national case files. (41) In order to facilitate cooperation between the EDPS and the national supervisory authorities, but without prejudice to the independence of the EDPS or to his or her responsibility for supervision of Eurojust with regard to data protection, the EDPS and national supervisory authorities should regularly meet within the European Data Protection Board, in line with the rules on coordinated supervision laid down in Regulation (EU) 2018/1725. (42) As the first recipient on the territory of the Union of data provided by or retrieved from third countries or international organisations, Eurojust should be responsible for the accuracy of such data. Eurojust should take measures to verify as far as possible the accuracy of the data upon receiving the data or when making data available to other authorities. (43) Eurojust should be subject to the general rules on contractual and non-contractual liability applicable to Union institutions, bodies, offices and agencies. (44) Eurojust should be able to exchange relevant personal data and maintain cooperative relations with other Union institutions, bodies, offices or agencies to the extent necessary for the fulfilment of its or their tasks. (45) To guarantee purpose limitation, it is important to ensure that personal data can be transferred by Eurojust to third countries and international organisations only if necessary for preventing and combating crime that falls within Eurojust\u2019s tasks. To this end, it is necessary to ensure that, when personal data are transferred, the recipient gives an undertaking that the data will be used by the recipient or transferred onward to a competent authority of a third country solely for the purpose for which they were originally transferred. Further onward transfer of the data should take place in compliance with this Regulation. (46) All Member States are affiliated to the International Criminal Police Organisation (Interpol). To fulfil its mission, Interpol receives, stores and circulates personal data to assist competent authorities in preventing and combating international crime. It is therefore appropriate to strengthen cooperation between the Union and Interpol by promoting an efficient exchange of personal data while ensuring respect for fundamental rights and freedoms regarding the automatic processing of personal data. Where operational personal data are transferred from Eurojust to Interpol, and to countries which have delegated members to Interpol, this Regulation, in particular the provisions on international transfers, should apply. This Regulation should be without prejudice to the specific rules laid down in Council Common Position 2005/69/JHA (11) and Council Decision 2007/533/JHA (12). (47) When Eurojust transfers operational personal data to an authority of a third country or to an international organisation by virtue of an international agreement concluded pursuant to Article 218 TFEU, adequate safeguards should be provided for with respect to the protection of privacy and fundamental rights and freedoms of individuals to ensure that the applicable data protection rules are complied with. (48) Eurojust should ensure that a transfer to a third country or to an international organisation takes place only if necessary for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security, and that the controller in the third country or international organisation is an authority competent within the meaning of this Regulation. A transfer should be carried out only by Eurojust acting as controller. Such a transfer may take place in cases where the Commission has decided that the third country or international organisation in question ensures an adequate level of protection, where appropriate safeguards have been provided, or where derogations for specific situations apply. (49) Eurojust should be able to transfer personal data to an authority of a third country or an international organisation on the basis of a Commission decision finding that the country or international organisation in question ensures an adequate level of data protection (\u2018adequacy decision\u2019), or, in the absence of an adequacy decision, an international agreement concluded by the Union pursuant to Article 218 TFEU, or a cooperation agreement allowing for the exchange of personal data concluded between Eurojust and the third country prior to the date of application of this Regulation. (50) Where the College identifies an operational need for cooperation with a third country or an international organisation, it should be able to suggest that the Council draw the attention of the Commission to the need for an adequacy decision or for a recommendation for the opening of negotiations on an international agreement pursuant to Article 218 TFEU. (51) Transfers not based on an adequacy decision should be allowed only where appropriate safeguards have been provided in a legally binding instrument which ensures the protection of personal data or where Eurojust has assessed all the circumstances surrounding the data transfer and, on the basis of that assessment, considers that appropriate safeguards with regard to the protection of personal data exist. Such legally binding instruments could, for example, be legally binding bilateral agreements which have been concluded by the Member States and implemented in their legal order and which could be enforced by their data subjects, ensuring compliance with data protection requirements and the rights of the data subjects, including the right to obtain effective administrative or judicial redress. Eurojust should be able to take into account cooperation agreements concluded between Eurojust and third countries which allow for the exchange of personal data when carrying out the assessment of all the circumstances surrounding the data transfer. Eurojust should be able to also take into account the fact that the transfer of personal data will be subject to confidentiality obligations and the principle of specificity, ensuring that the data will not be processed for other purposes than for the purposes of the transfer. In addition, Eurojust should take into account that the personal data will not be used to request, hand down or execute a death penalty or any form of cruel and inhuman treatment. While those conditions could be considered to be appropriate safeguards allowing the transfer of data, Eurojust should be able to require additional safeguards. (52) Where no adequacy decision or appropriate safeguards exist, a transfer or a category of transfers could take place only in specific situations, if necessary to protect the vital interests of the data subject or another person, or to safeguard legitimate interests of the data subject where the law of the Member State transferring the personal data so provides; for the prevention of an immediate and serious threat to the public security of a Member State or a third country; in an individual case for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; or in an individual case for the establishment, exercise or defence of legal claims. Those derogations should be interpreted restrictively and should not allow frequent, massive and structural transfers of personal data, or large-scale transfers of data, but should be limited to data strictly necessary. Such transfers should be documented and should be made available to the EDPS on request in order to monitor the lawfulness of the transfer. (53) In exceptional cases, Eurojust should be able to extend the deadlines for the storage of operational personal data in order to achieve its objectives, subject to observance of the purpose limitation principle applicable to processing of personal data in the context of all its activities. Such decisions should be taken following careful consideration of all interests at stake, including those of the data subjects. Any extension of a deadline for processing personal data in cases where prosecution is time-barred in all Member States concerned should be decided only where there is a specific need to provide assistance under this Regulation. (54) Eurojust should maintain privileged relations with the European Judicial Network based on consultation and complementarity. This Regulation should help clarify the respective roles of Eurojust and the European Judicial Network and their mutual relations, while maintaining the specificity of the European Judicial Network. (55) Eurojust should maintain cooperative relations with other Union institutions, bodies, offices and agencies, with the EPPO, with the competent authorities of third countries and with international organisations, to the extent required for the fulfilment of its tasks. (56) To enhance operational cooperation between Eurojust and Europol, and particularly to establish links between data already in the possession of either agency, Eurojust should enable Europol to have access, on the basis of a hit/no-hit system, to data held by Eurojust. Eurojust and Europol should ensure that the necessary arrangements are established to optimise their operational cooperation, taking due account of their respective mandates and any restrictions provided by the Member States. These working arrangements should ensure access to, and the possibility of searching, all information that has been provided to Europol for the purpose of cross-checking in accordance with the specific safeguards and data protection guarantees provided for in this Regulation. Any access by Europol to data held by Eurojust should be limited by technical means to information falling within the respective mandates of those Union agencies. (57) Eurojust and Europol should keep each other informed of any activity involving the financing of joint investigation teams. (58) Eurojust should be able to exchange personal data with Union institutions, bodies, offices and agencies to the extent necessary for the fulfilment of its tasks, with full respect for the protection of privacy and other fundamental rights and freedoms. (59) Eurojust should enhance its cooperation with competent authorities of third countries and international organisations on the basis of a strategy drawn up in consultation with the Commission. For that purpose, provision should be made for Eurojust to post liaison magistrates to third countries in order to achieve objectives similar to those assigned to liaison magistrates seconded by the Member States on the basis of Council Joint Action 96/277/JHA (13). (60) Provision should be made for Eurojust to coordinate the execution of requests for judicial cooperation issued by a third country, where those requests require execution in at least two Member States as part of the same investigation. Eurojust should only undertake such coordination with the agreement of the Member States concerned. (61) To guarantee the full autonomy and independence of Eurojust, it should be granted an autonomous budget sufficient to properly carry out its work, with revenue coming essentially from a contribution from the budget of the Union, except as regards the salaries and emoluments of the national members, deputies and Assistants, which are borne by their Member State. The Union budgetary procedure should be applicable as far as the Union contribution and other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors and approved by the Committee on Budgetary Control of the European Parliament. (62) In order to increase the transparency and democratic oversight of Eurojust, it is necessary to provide a mechanism pursuant to Article 85(1) TFEU for the joint evaluation of Eurojust\u2019s activities by the European Parliament and national parliaments. The evaluation should take place in the framework of an inter-parliamentary committee meeting in the premises of the European Parliament in Brussels, with the participation of members of the competent committees of the European Parliament and of the national parliaments. The interparliamentary committee meeting should fully respect Eurojust\u2019s independence as regards actions to be taken in specific operational cases and as regards the obligation of discretion and confidentiality. (63) It is appropriate to evaluate the application of this Regulation regularly. (64) Eurojust\u2019s functioning should be transparent in accordance with Article 15(3) TFEU. Specific provisions on how the right of public access to documents is ensured should be adopted by the College. Nothing in this Regulation is intended to restrict the right of public access to documents in so far as it is guaranteed in the Union and in the Member States, in particular under Article 42 of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019). The general rules on transparency that apply to Union agencies should also apply to Eurojust in a way that does not jeopardise in any manner the obligation of confidentiality in its operational work. Administrative inquiries conducted by the European Ombudsman should respect the obligation of confidentiality of Eurojust. (65) In order to increase Eurojust\u2019s transparency vis-\u00e0-vis Union citizens and its accountability, Eurojust should publish a list of its Executive Board members on its website and, where appropriate, summaries of the outcome of the meetings of the Executive Board, while respecting data protection requirements. (66) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (14) should apply to Eurojust. (67) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (15) should apply to Eurojust. (68) The necessary provisions regarding accommodation for Eurojust in the Member State in which it has its headquarters, that is to say in the Netherlands, and the specific rules applicable to all Eurojust\u2019s staff and members of their families should be laid down in a headquarters agreement. The host Member State should provide the best possible conditions to ensure the functioning of Eurojust, including multilingual, European-oriented schooling and appropriate transport connections, so as to attract high-quality human resources from as wide a geographical area as possible. (69) Eurojust as established by this Regulation should be the legal successor of Eurojust as established by Decision 2002/187/JHA with respect to all its contractual obligations, including employment contracts, liabilities and properties acquired. International agreements concluded by Eurojust as established by that Decision should remain in force. (70) Since the objective of this Regulation, namely the setting up of an entity responsible for supporting and strengthening coordination and cooperation between judicial authorities of the Member States in relation to serious crime affecting two or more Member States or requiring a prosecution on common bases, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (71) In accordance with Articles 1 and 2 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, those Member States are not taking part in the adoption of this Regulation and are not bound by it or subject to its application. (72) In accordance with Articles 1 and 2 of the Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (73) The EDPS was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (16) and delivered an opinion on 5 March 2014. (74) This Regulation fully respects the fundamental rights and safeguards and observes the principles recognised in particular by the Charter, HAVE ADOPTED THIS REGULATION: CHAPTER I ESTABLISHMENT, OBJECTIVES AND TASKS OF EUROJUST Article 1 Establishment of the European Union Agency for Criminal Justice Cooperation 1. The European Union Agency for Criminal Justice Cooperation (Eurojust) is hereby established. 2. Eurojust as established by this Regulation shall replace and succeed Eurojust as established by Decision 2002/187/JHA. 3. Eurojust shall have legal personality. Article 2 Tasks 1. Eurojust shall support and strengthen coordination and cooperation between national investigating and prosecuting authorities in relation to serious crime which Eurojust is competent to deal with in accordance with Article 3(1) and (3), where that crime affects two or more Member States, or requires prosecution on common bases, on the basis of operations conducted and information supplied by the Member States\u2019 authorities, by Europol, by the EPPO and by OLAF. 2. In carrying out its tasks, Eurojust shall: (a) take into account any request emanating from a competent authority of a Member State, any information provided by Union authorities, institutions, bodies, offices and agencies competent by virtue of provisions adopted within the framework of the Treaties and any information collected by Eurojust itself; (b) facilitate the execution of requests for, and decisions on, judicial cooperation, including requests and decisions based on instruments that give effect to the principle of mutual recognition. 3. Eurojust shall carry out its tasks at the request of the competent authorities of the Member States, on its own initiative or at the request of the EPPO within the limits of the EPPO\u2019s competence. Article 3 Competence of Eurojust 1. Eurojust shall be competent with respect to the forms of serious crime listed in Annex I. However, as of the date on which the EPPO assumes its investigative and prosecutorial tasks in accordance with Article 120(2) of Regulation (EU) 2017/1939, Eurojust shall not exercise its competence with regard to crimes for which the EPPO exercises its competence, except in those cases where Member States which do not participate in enhanced cooperation on the establishment of the EPPO are also involved and at the request of those Member States or at the request of the EPPO. 2. Eurojust shall exercise its competence for crimes affecting the financial interests of the Union in cases involving Member States which participate in enhanced cooperation on the establishment of the EPPO but in respect of which the EPPO does not have competence or decides not to exercise its competence. Eurojust, the EPPO and the Member States concerned shall consult and cooperate with each other to facilitate Eurojust\u2019s exercise of competence under this paragraph. The practical details of its exercise of competence under this paragraph shall be governed by a working arrangement as referred to in Article 47(3). 3. As regards forms of crime other than those listed in Annex I, Eurojust may also, in accordance with its tasks, assist with investigations and prosecutions where requested by a competent authority of a Member State. 4. Eurojust\u2019s competence shall cover criminal offences related to the criminal offences listed in Annex I. The following categories of offences shall be regarded as related criminal offences: (a) criminal offences committed in order to procure the means of committing the serious crimes listed in Annex I; (b) criminal offences committed in order to facilitate or commit the serious crimes listed in Annex I; (c) criminal offences committed in order to ensure the impunity of those committing the serious crimes listed in Annex I. 5. At the request of a Member State\u2019s competent authority, Eurojust may also assist with investigations and prosecutions that only affect that Member State and a third country, provided that a cooperation agreement or arrangement establishing cooperation pursuant to Article 52 has been concluded with that third country or provided that in a specific case there is an essential interest in providing such assistance. 6. At the request of either the competent authority of a Member State or the Commission, Eurojust may assist in investigations and prosecutions that only affect that Member State but which have repercussions at Union level. Before acting at the request of the Commission, Eurojust shall consult the competent authority of the Member State concerned. That competent authority may, within a deadline set by Eurojust, oppose the execution of the request by Eurojust, justifying its position in every case. Article 4 Operational functions of Eurojust 1. Eurojust shall: (a) inform the competent authorities of the Member States of investigations and prosecutions of which it has been informed which have repercussions at Union level or which might affect Member States other than those directly concerned; (b) assist the competent authorities of the Member States in ensuring the best possible coordination of investigations and prosecutions; (c) assist in improving cooperation between the competent authorities of the Member States, in particular on the basis of Europol\u2019s analyses; (d) cooperate and consult with the European Judicial Network in criminal matters, including by making use of and contributing to the improvement of the documentary database of the European Judicial Network; (e) cooperate closely with the EPPO on matters relating to its competence; (f) provide operational, technical and financial support to Member States\u2019 cross-border operations and investigations, including to joint investigation teams; (g) support, and where appropriate participate in, the Union centres of specialised expertise developed by Europol and other Union institutions, bodies, offices and agencies; (h) cooperate with Union institutions, bodies, offices and agencies, as well as networks established in the area of freedom, security and justice regulated under Title V of the TFEU; (i) support Member States\u2019 action in combating forms of serious crime listed in Annex I. 2. In carrying out its tasks, Eurojust may ask the competent authorities of the Member States concerned, giving its reasons, to: (a) undertake an investigation or prosecution of specific acts; (b) accept that one of them may be in a better position to undertake an investigation or to prosecute specific acts; (c) coordinate between the competent authorities of the Member States concerned; (d) set up a joint investigation team in accordance with the relevant cooperation instruments; (e) provide it with any information that is necessary for carrying out its tasks; (f) take special investigative measures; (g) take any other measure justified for the investigation or prosecution. 3. Eurojust may also: (a) provide Europol with opinions based on analyses carried out by Europol; (b) supply logistical support, including translation, interpretation and the organisation of coordination meetings. 4. Where two or more Member States cannot agree as to which of them should undertake an investigation or prosecution following a request under points (a) or (b) of paragraph 2, Eurojust shall issue a written opinion on the case. Eurojust shall send the opinion to the Member States concerned immediately. 5. At the request of a competent authority, or on its own initiative, Eurojust shall issue a written opinion on recurrent refusals or difficulties concerning the execution of requests for, and decisions on, judicial cooperation, including requests and decisions based on instruments giving effect to the principle of mutual recognition, provided that it is not possible to resolve such cases through mutual agreement between the competent national authorities or through the involvement of the national members concerned. Eurojust shall send the opinion to the Member States concerned immediately. 6. The competent authorities of the Member States concerned shall respond to requests from Eurojust under paragraph 2 and to the written opinions referred to in paragraph 4 or 5 without undue delay. The competent authorities of the Member States may refuse to comply with such requests or to follow the written opinion if doing so would harm essential national security interests, would jeopardise the success of an ongoing investigation or would jeopardise the safety of an individual. Article 5 Exercise of operational and other functions 1. Eurojust shall act through one or more of the national members concerned when taking any of the actions referred to in Article 4(1) or (2). Without prejudice to paragraph 2 of this Article, the College shall focus on operational issues and any other issues that are directly linked to operational matters. The College shall only be involved in administrative matters to the extent necessary to ensure that its operational functions are fulfilled. 2. Eurojust shall act as a College: (a) when taking any of the actions referred to in Article 4(1) or (2): (i) at the request of one or more of the national members concerned by a case dealt with by Eurojust; (ii) where the case involves investigations or prosecutions which have repercussions at Union level or which might affect Member States other than those directly concerned; (b) when taking any of the actions referred to in Article 4(3), (4) or (5); (c) where a general question relating to the achievement of its operational objectives is involved; (d) when adopting Eurojust\u2019s annual budget, in which case the decision shall be taken by a majority of two thirds of its members; (e) when adopting the programming document referred to in Article 15 or the annual report on Eurojust\u2019s activities, in which cases the decision shall be taken by a majority of two thirds of its members; (f) when electing or dismissing the President and Vice-Presidents under Article 11; (g) when appointing the Administrative Director or, where relevant, extending his or her term of office or removing him or her from office under Article 17; (h) when adopting working arrangements under Articles 47(3) and 52; (i) when adopting rules for the prevention and management of conflicts of interest in respect of its members, including in relation to their declaration of interests; (j) when adopting reports, policy papers, guidelines for the benefit of national authorities and opinions pertaining to the operational work of Eurojust, whenever those documents are of a strategic nature; (k) when appointing liaison magistrates in accordance with Article 53; (l) when taking any decision which is not expressly attributed to the Executive Board by this Regulation or which is not under the responsibility of the Administrative Director in accordance with Article 18; (m) when otherwise provided for in this Regulation. 3. When it fulfils its tasks, Eurojust shall indicate whether it is acting through one or more of the national members or as a College. 4. The College may assign additional administrative tasks to the Administrative Director and the Executive Board beyond those provided for in Articles 16 and 18, in accordance with its operational needs. Where exceptional circumstances so require, the College may decide to suspend temporarily the delegation of the appointing authority powers to the Administrative Director and of those powers that have been sub-delegated by the latter, and to exercise them itself or to delegate them to one of its members or to a staff member other than the Administrative Director. 5. The College shall adopt Eurojust\u2019s rules of procedure on the basis of a two-thirds majority of its members. In the event that agreement cannot be reached by a two-thirds majority, the decision shall be taken by simple majority. Eurojust\u2019s rules of procedure shall be approved by the Council by means of implementing acts. CHAPTER II STRUCTURE AND ORGANISATION OF EUROJUST SECTION I Structure Article 6 Structure of Eurojust Eurojust shall comprise: (a) the national members; (b) the College; (c) the Executive Board; (d) the Administrative Director. SECTION II National members Article 7 Status of national members 1. Eurojust shall have one national member seconded by each Member State in accordance with its legal system. That national member shall have his or her regular place of work at the seat of Eurojust. 2. Each national member shall be assisted by one deputy and by one Assistant. In principle, the deputy and the Assistant shall have their regular place of work at the seat of Eurojust. Each Member State may decide that the deputy or Assistant or both will have their regular place of work in their Member State. If a Member State takes such a decision, it shall notify the College. If the operational needs of Eurojust so require, the College may request the Member State to assign the deputy or Assistant or both to work at the seat of Eurojust for a specified period. The Member State shall comply with such a request from the College without undue delay. 3. Additional deputies or Assistants may assist the national member and, if necessary and with the agreement of the College, may have their regular place of work at Eurojust. Member States shall notify Eurojust and the Commission of the appointment of national members, deputies and Assistants. 4. National members and deputies shall have the status of a prosecutor, a judge or a representative of a judicial authority with competences equivalent to those of a prosecutor or judge under their national law. The Member States shall grant them at least the powers referred to in this Regulation in order to be able to fulfil their tasks. 5. The terms of office of the national members and their deputies shall be five years, renewable once. In cases where a deputy is unable to act on behalf of a national member or is unable to substitute for a national member, the national member shall remain in office upon expiry of his or her term of office until the renewal of his or her term or his or her replacement, subject to the consent of their Member State. 6. Member States shall appoint national members and deputies on the basis of a proven high level of relevant, practical experience in the field of criminal justice. 7. The deputy shall be able to act on behalf of or to substitute for the national member. An Assistant may also act on behalf of or substitute for the national member if he or she has a status referred to in paragraph 4. 8. Operational information exchange between Eurojust and Member States shall take place through the national members. 9. The salaries and emoluments of the national members, deputies and Assistants shall be borne by their Member State without prejudice to Article 12. 10. Where national members, deputies and Assistants act within the framework of Eurojust\u2019s tasks, the relevant expenditure related to those activities shall be regarded as operational expenditure. Article 8 Powers of national members 1. The national members shall have the power to: (a) facilitate or otherwise support the issuing or execution of any request for mutual legal assistance or mutual recognition; (b) directly contact and exchange information with any competent national authority of the Member State or any other competent Union body, office or agency, including the EPPO; (c) directly contact and exchange information with any competent international authority, in accordance with the international commitments of their Member State; (d) participate in joint investigation teams including in setting them up. 2. Without prejudice to paragraph 1, Member States may grant additional powers to national members in accordance with their national law. Those Member States shall notify the Commission and the College of these powers. 3. With the agreement of the competent national authority, national members may, in accordance with their national law: (a) issue or execute any request for mutual legal assistance or mutual recognition; (b) order, request or execute investigative measures, as provided for in Directive 2014/41/EU of the European Parliament and of the Council (17). 4. In urgent cases where it is not possible to identify or to contact the competent national authority in a timely manner, national members shall be competent to take the measures referred to in paragraph 3 in accordance with their national law, provided that they inform the competent national authority as soon as possible. 5. The national member may submit a proposal to the competent national authority to carry out the measures referred to in paragraphs 3 and 4 where the exercise of the powers referred to in paragraphs 3 and 4 by that national member would be in conflict with: (a) a Member State\u2019s constitutional rules; or (b) fundamental aspects of that Member State\u2019s national criminal justice system regarding: (i) the division of powers between the police, prosecutors and judges; (ii) the functional division of tasks between prosecution authorities; or (iii) the federal structure of the Member State concerned. 6. Member States shall ensure that, in cases referred to in paragraph 5, the proposal submitted by their national member is handled without undue delay by the competent national authority. Article 9 Access to national registers National members shall have access to, or at least be able to obtain the information contained in, the following types of registers of their Member State, in accordance with their national law: (a) criminal records; (b) registers of arrested persons; (c) investigation registers; (d) DNA registers; (e) other registers of public authorities of their Member State where such information is necessary to fulfil their tasks. SECTION III The College Article 10 Composition of the College 1. The College shall be composed of: (a) all the national members; and (b) one representative of the Commission when the College exercises its management functions. The representative of the Commission nominated under point (b) of the first subparagraph should be the same person as the Commission\u2019s representative on the Executive Board under Article 16(4). 2. The Administrative Director shall attend the management meetings of the College, without the right to vote. 3. The College may invite any person whose opinion may be of interest to attend its meetings as an observer. 4. The members of the College may, subject to the provisions of Eurojust\u2019s rules of procedure, be assisted by advisers or experts. Article 11 The President and Vice-President of Eurojust 1. The College shall elect a President and two Vice-Presidents from among the national members by a two-thirds majority of its members. In the event that a two-thirds majority cannot be reached after the second round of election, the Vice-Presidents shall be elected by a simple majority of the members of the College, while a two-thirds majority shall continue to be necessary for the election of the President. 2. The President shall exercise his or her functions on behalf of the College. The President shall: (a) represent Eurojust; (b) call and preside over the meetings of the College and the Executive Board and keep the College informed of any matters that are of interest to it; (c) direct the work of the College and monitor Eurojust\u2019s daily management by the Administrative Director; (d) exercise any other functions set out in Eurojust\u2019s rules of procedure. 3. The Vice-Presidents shall exercise the functions set out in paragraph 2 which the President entrusts to them. They shall replace the President if he or she is prevented from attending to his or her duties. The President and Vice-Presidents shall be assisted in the performance of their specific duties by the administrative staff of Eurojust. 4. The term of office of the President and the Vice-Presidents shall be four years. They may be re-elected once. 5. When a national member is elected President or Vice-President of Eurojust, his or her term of office shall be extended to ensure that he or she can fulfil his or her function as President or Vice-President. 6. If the President or Vice-President no longer fulfils the conditions required for the performance of his or her duties, he or she may be dismissed by the College acting on a proposal from one third of its members. The decision shall be adopted on the basis of a two-thirds majority of the members of the College, excluding the President or Vice-President concerned. 7. When a national member is elected President of Eurojust, the Member State concerned may second another suitably qualified person to reinforce the national desk for the duration of the former\u2019s mandate as President. A Member State which decides to second such a person shall be entitled to apply for compensation in accordance with Article 12. Article 12 Compensation mechanism for the election to the position of President 1. By 12 December 2019, the Council shall, acting on a proposal by the Commission and by means of implementing acts, determine a mechanism for compensation, for the purpose of Article 11(7), to be made available to Member States whose national member is elected President. 2. The compensation shall be available to any Member State if: (a) its national member has been elected President; and (b) it requests compensation from the College and provides justification for the need to reinforce its national desk on grounds of an increased workload. 3. The compensation provided shall equate to 50 % of the national salary of the seconded person. Compensation for living costs and other associated expenses shall be provided on a comparable basis to that provided to Union officials or other servants seconded abroad. 4. The costs of the compensation mechanism shall be borne by Eurojust\u2019s budget. Article 13 Meetings of the College 1. The President shall convene the meetings of the College. 2. The College shall hold at least one meeting per month. In addition, it shall meet on the initiative of the President, at the request of the Commission to discuss the administrative tasks of the College, or at the request of at least one third of its members. 3. Eurojust shall send the EPPO the agenda of College meetings whenever issues are discussed which are of relevance for the exercise of the tasks of the EPPO. Eurojust shall invite the EPPO to participate in such meetings, without the right to vote. When the EPPO is invited to a College meeting, Eurojust shall provide it with the relevant documents supporting the agenda. Article 14 Voting rules of the College 1. Unless stated otherwise, and where a consensus cannot be reached, the College shall take its decisions by a majority of its members. 2. Each member shall have one vote. In the absence of a voting member, the deputy shall be entitled to exercise the right to vote subject to the conditions set out in Article 7(7). In the absence of the deputy, the Assistant shall also be entitled to exercise the right to vote subject to the conditions set out in Article 7(7). Article 15 Annual and multi-annual programming 1. By 30 November each year, the College shall adopt a programming document containing annual and multi-annual programming, based on a draft prepared by the Administrative Director, taking into account the opinion of the Commission. The College shall forward the programming document to the European Parliament, the Council, the Commission and the EPPO. The programming document shall become definitive after final adoption of the general budget of the Union and shall be adjusted accordingly, if necessary. 2. The annual work programme shall comprise detailed objectives and expected results including performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual work programme shall be coherent with the multi-annual work programme referred to in paragraph 4. It shall clearly indicate which tasks have been added, changed or deleted in comparison with the previous financial year. 3. The College shall amend the adopted annual work programme when a new task is given to Eurojust. Any substantial amendment to the annual work programme shall be adopted by the same procedure as the initial annual work programme. The College may delegate to the Administrative Director the power to make non-substantial amendments to the annual work programme. 4. The multi-annual work programme shall set out overall strategic programming including objectives, the strategy for cooperation with the authorities of third countries and international organisations referred to in Article 52, expected results and performance indicators. It shall also set out resource programming including multi-annual budget and staff. The resource programming shall be updated annually. The strategic programming shall be updated where appropriate, and in particular to address the outcome of the evaluation referred to in Article 69. SECTION IV The executive board Article 16 Functioning of the Executive Board 1. The College shall be assisted by an Executive Board. The Executive Board shall be responsible for taking administrative decisions to ensure the proper functioning of Eurojust. It shall oversee the necessary preparatory work of the Administrative Director on other administrative matters for adoption by the College. It shall not be involved in the operational functions of Eurojust referred to in Articles 4 and 5. 2. The Executive Board may consult the College when carrying out its tasks. 3. The Executive Board shall also: (a) review Eurojust\u2019s programming document referred to in Article 15 based on the draft prepared by the Administrative Director and forward it to the College for adoption; (b) adopt an anti-fraud strategy for Eurojust, proportionate to the fraud risks, taking into account the costs and benefits of the measures to be implemented and based on a draft prepared by the Administrative Director; (c) adopt appropriate implementing rules giving effect to the Staff Regulations of Officials of the European Union (the \u2018Staff Regulations of Officials\u2019) and the Conditions of Employment of Other Servants of the European Union (\u2018Conditions of Employment of Other Servants\u2019), laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (18) in accordance with Article 110 of the Staff Regulations of Officials; (d) ensure adequate follow-up to the findings and recommendations stemming from the internal or external audit reports, evaluations and investigations, including those of the EDPS and OLAF; (e) take all decisions on the establishment and, where necessary, the modification of Eurojust\u2019s internal administrative structures; (f) without prejudice to the responsibilities of the Administrative Director set out in Article 18, assist and advise him or her on the implementation of the decisions of the College, with a view to reinforcing supervision of administrative and budgetary management; (g) undertake any additional administrative tasks assigned to it by the College under Article 5(4); (h) adopt the financial rules applicable to Eurojust in accordance with Article 64; (i) adopt, in accordance with Article 110 of the Staff Regulations of Officials, a decision based on Article 2(1) of the Staff Regulations of Officials and on Article 6 of the Conditions of Employment of Other Servants delegating the relevant appointing authority powers to the Administrative Director and establishing the conditions under which this delegation of powers can be suspended; the Administrative Director shall be authorised to sub-delegate those powers; (j) review Eurojust\u2019s draft annual budget for adoption by the College; (k) review the draft annual report on Eurojust\u2019s activities and forward it to the College for adoption; (l) appoint an accounting officer and a Data Protection Officer who are functionally independent in the performance of their duties. 4. The Executive Board shall be composed of the President and Vice-Presidents of Eurojust, one representative of the Commission and two other members of the College designated on a two-year rotation system in accordance with Eurojust\u2019s rules of procedure. The Administrative Director shall attend the meetings of the Executive Board without the right to vote. 5. The President of Eurojust shall be the chairperson of the Executive Board. The Executive Board shall take its decisions by a majority of its members. Each member shall have one vote. In the event of a tied vote, the President of Eurojust shall have a casting vote. 6. The term of office of members of the Executive Board shall end when their term as national members, President or Vice-President ends. 7. The Executive Board shall meet at least once a month. In addition, it shall meet on the initiative of its chairperson or at the request of the Commission or of at least two of its other members. 8. Eurojust shall send to the EPPO the agenda of the Executive Board meetings and consult with the EPPO on the need to participate in those meetings. Eurojust shall invite the EPPO to participate, without the right to vote, whenever issues are discussed which are of relevance for the functioning of the EPPO. When the EPPO is invited to an Executive Board meeting, Eurojust shall provide it with the relevant documents supporting the agenda. SECTION V The Administrative Director Article 17 Status of the Administrative Director 1. The Administrative Director shall be engaged as a temporary agent of Eurojust under point (a) of Article 2 of the Conditions of Employment of Other Servants. 2. The Administrative Director shall be appointed by the College from a list of candidates proposed by the Executive Board, following an open and transparent selection procedure in accordance with Eurojust\u2019s rules of procedure. For the purpose of concluding the employment contract with the Administrative Director, Eurojust shall be represented by the President of Eurojust. 3. The term of office of the Administrative Director shall be four years. By the end of that period, the Executive Board shall undertake an assessment that takes into account an evaluation of the performance of the Administrative Director. 4. The College, acting on a proposal from the Executive Board that takes into account the assessment referred to in paragraph 3, may extend the term of office of the Administrative Director once and for no more than four years. 5. An Administrative Director whose term of office has been extended shall not participate in another selection procedure for the same post at the end of the overall period. 6. The Administrative Director shall be accountable to the College. 7. The Administrative Director may be removed from the office only pursuant to a decision of the College acting on a proposal from the Executive Board. Article 18 Responsibilities of the Administrative Director 1. For administrative purposes, Eurojust shall be managed by its Administrative Director. 2. Without prejudice to the powers of the College or the Executive Board, the Administrative Director shall be independent in the performance of his or her duties and shall neither seek nor take instructions from any government or any other body. 3. The Administrative Director shall be the legal representative of Eurojust. 4. The Administrative Director shall be responsible for the implementation of the administrative tasks assigned to Eurojust, in particular: (a) the day-to-day administration of Eurojust and staff management; (b) implementing the decisions adopted by the College and the Executive Board; (c) preparing the programming document referred to in Article 15 and submitting it to the Executive Board for review; (d) implementing the programming document referred to in Article 15 and reporting to the Executive Board and College on its implementation; (e) preparing the annual report on Eurojust\u2019s activities and presenting it to the Executive Board for review and to the College for adoption; (f) preparing an action plan following up on conclusions of internal or external audit reports, evaluations and investigations, including those of the EDPS and OLAF and reporting on progress twice a year to the College, to the Executive Board, to the Commission and to the EDPS; (g) preparing an anti-fraud strategy for Eurojust and presenting it to the Executive Board for adoption; (h) preparing draft financial rules applicable to Eurojust; (i) preparing Eurojust\u2019s draft statement of estimates of revenue and expenditure and implementing its budget; (j) exercising, with respect to the staff of Eurojust, the powers conferred by the Staff Regulations of Officials on the appointing authority and by the Conditions of Employment of Other Servants on the authority empowered to conclude contracts of employment of other servants (\u2018the appointing authority powers\u2019); (k) ensuring that the necessary administrative support is provided to facilitate the operational work of Eurojust; (l) ensuring that support is provided to the President and Vice-Presidents as they carry out their duties; (m) preparing a draft proposal for Eurojust\u2019s annual budget, which shall be reviewed by the Executive Board before adoption by the College. CHAPTER III OPERATIONAL MATTERS Article 19 On-call coordination mechanism 1. In order to fulfil its tasks in urgent cases, Eurojust shall operate an on-call coordination mechanism (\u2018OCC\u2019) able to receive and process at all times the requests referred to it. The OCC shall be contactable 24 hours a day, seven days a week. 2. The OCC shall rely on one OCC representative per Member State who may be either the national member, his or her deputy, an Assistant entitled to replace the national member, or a seconded national expert. The OCC representative shall be available to act 24 hours a day, seven days a week. 3. The OCC representatives shall act efficiently and without delay in relation to the execution of a request in their Member State. Article 20 Eurojust national coordination system 1. Each Member State shall appoint one or more national correspondents for Eurojust. 2. All national correspondents appointed by the Member States under paragraph 1 shall have the skills and experience necessary for them to carry out their duties. 3. Each Member State shall set up a Eurojust national coordination system to ensure coordination of the work carried out by: (a) the national correspondents for Eurojust; (b) any national correspondents for issues relating to the competence of the EPPO; (c) the national correspondent for Eurojust for terrorism matters; (d) the national correspondent for the European Judicial Network in criminal matters and up to three other contact points of the European Judicial Network; (e) national members or contact points of the Network for joint investigation teams, and national members or contact points of the networks set up by Decisions 2002/494/JHA, 2007/845/JHA and 2008/852/JHA; (f) where applicable, any other relevant judicial authority. 4. The persons referred to in paragraphs 1 and 3 shall retain their position and status under national law, without this having a significant impact on the performance of their duties under this Regulation. 5. The national correspondents for Eurojust shall be responsible for the functioning of their Eurojust national coordination system. Where several correspondents for Eurojust are appointed, one of them shall be responsible for the functioning of their Eurojust national coordination system. 6. The national members shall be informed of all meetings of their Eurojust national coordination system where casework-related matters are discussed. The national members may attend such meetings as necessary. 7. Each Eurojust national coordination system shall facilitate the carrying out of Eurojust\u2019s tasks within the Member State concerned, in particular by: (a) ensuring that the case management system referred to in Article 23 receives information related to the Member State concerned in an efficient and reliable manner; (b) assisting in determining whether a request should be handled with the assistance of Eurojust or of the European Judicial Network; (c) assisting the national member in identifying relevant authorities for the execution of requests for, and decisions on, judicial cooperation, including requests and decisions based on instruments giving effect to the principle of mutual recognition; (d) maintaining close relations with the Europol national unit, other contact points of the European Judicial Network and other relevant competent national authorities. 8. In order to meet the objectives referred to in paragraph 7, the persons referred to in paragraph 1 and in points (a), (b) and (c) of paragraph 3 shall, and the persons or authorities referred to in points (d) and (e) of paragraph 3 may be connected to the case management system in accordance with this Article and with Articles 23, 24, 25 and 34. The cost of connection to the case management system shall be borne by the general budget of the Union. 9. The setting up of the Eurojust national coordination system and the appointment of national correspondents shall not prevent direct contacts between the national member and the competent authorities of his or her Member State. Article 21 Exchanges of information with the Member States and between national members 1. The competent authorities of the Member States shall exchange with Eurojust all information necessary for the performance of its tasks under Articles 2 and 4 in accordance with the applicable data protection rules. This shall at least include the information referred to in paragraphs 4, 5 and 6 of this Article. 2. The transmission of information to Eurojust shall only be interpreted as a request for the assistance of Eurojust in the case concerned if so specified by a competent authority. 3. The national members shall exchange all information necessary for the performance of Eurojust\u2019s tasks among themselves or with their competent national authorities, without prior authorisation. In particular, the competent national authorities shall promptly inform their national members of a case which concerns them. 4. The competent national authorities shall inform their national members of the setting up of joint investigation teams and of the results of the work of such teams. 5. The competent national authorities shall inform their national members without undue delay of any case affecting at least three Member States for which requests for or decisions on judicial cooperation, including requests and decisions based on instruments giving effect to the principle of mutual recognition, have been transmitted to at least two Member States, where one or more of the following apply: (a) the offence involved is punishable in the requesting or issuing Member State by a custodial sentence or a detention order, the maximum period of which is at least five or six years, to be decided by the Member State concerned, and is included in the following list: (i) trafficking in human beings; (ii) sexual abuse or sexual exploitation including child pornography and solicitation of children for sexual purposes; (iii) drug trafficking; (iv) illicit trafficking in firearms, their parts or components or ammunition or explosives; (v) corruption; (vi) crime against the financial interests of the Union; (vii) forgery of money or means of payment; (viii) money laundering activities; (ix) computer crime; (b) there are factual indications that a criminal organisation is involved; (c) there are indications that the case may have a serious cross-border dimension or may have repercussions at Union level, or that it may affect Member States other than those directly involved. 6. The competent national authorities shall inform their national members of: (a) cases in which conflicts of jurisdiction have arisen or are likely to arise; (b) controlled deliveries affecting at least three countries, at least two of which are Member States; (c) repeated difficulties or refusals regarding the execution of requests for, or decisions on, judicial cooperation, including requests and decisions based on instruments giving effect to the principle of mutual recognition. 7. The competent national authorities shall not be obliged to supply information in a particular case if doing so would harm essential national security interests or jeopardise the safety of individuals. 8. This Article is without prejudice to conditions set out in bilateral or multilateral agreements or arrangements between Member States and third countries, including any conditions set by third countries concerning the use of information once supplied. 9. This Article is without prejudice to other obligations regarding the transmission of information to Eurojust, including Council Decision 2005/671/JHA (19). 10. Information referred to in this Article shall be provided in a structured way determined by Eurojust. The competent national authority shall not be obliged to provide such information where it has already been transmitted to Eurojust in accordance with other provisions of this Regulation. Article 22 Information provided by Eurojust to competent national authorities 1. Eurojust shall provide competent national authorities with information on the results of the processing of information, including the existence of links with cases already stored in the case management system, without undue delay. That information may include personal data. 2. Where a competent national authority requests that Eurojust provide it with information within a certain timeframe, Eurojust shall transmit that information within that timeframe. Article 23 Case management system, index and temporary work files 1. Eurojust shall establish a case management system composed of temporary work files and of an index which contain the personal data referred to in Annex II and non-personal data. 2. The purpose of the case management system shall be to: (a) support the management and coordination of investigations and prosecutions for which Eurojust is providing assistance, in particular by cross-referencing information; (b) facilitate access to information on on-going investigations and prosecutions; (c) facilitate the monitoring of the lawfulness of Eurojust\u2019s processing of personal data and its compliance with the applicable data protection rules. 3. The case management system may be linked to the secure telecommunications connection referred to in Article 9 of Council Decision 2008/976/JHA (20). 4. The index shall contain references to temporary work files processed within the framework of Eurojust and may not contain any personal data other than those referred to in points (1)(a) to (i), (k) and (m) and (2) of Annex II. 5. In the performance of their duties, national members may process data on the individual cases on which they are working in a temporary work file. They shall allow the Data Protection Officer to have access to the temporary work file. The Data Protection Officer shall be informed by the national member concerned of the opening of each new temporary work file that contains personal data. 6. For the processing of operational personal data, Eurojust may not establish any automated data file other than the case management system. The national member may, however, temporarily store and analyse personal data for the purpose of determining whether such data are relevant to Eurojust\u2019s tasks and can be included in the case management system. That data may be held for up to three months. Article 24 Functioning of temporary work files and the index 1. A temporary work file shall be opened by the national member concerned for every case with respect to which information is transmitted to him or her in so far as that transmission is in accordance with this Regulation or other applicable legal instruments. The national member shall be responsible for the management of the temporary work files opened by that national member. 2. The national member who has opened a temporary work file shall decide, on a case-by-case basis, whether to keep the temporary work file restricted or to give access to it or to parts of it to other national members, to authorised Eurojust staff or to any other person working on behalf of Eurojust who has received the necessary authorisation from the Administrative Director. 3. The national member who has opened a temporary work file shall decide which information related to that temporary work file shall be introduced in the index in accordance with Article 23(4). Article 25 Access to the case management system at national level 1. In so far as they are connected to the case management system, persons referred to in Article 20(3) shall only have access to: (a) the index, unless the national member who has decided to introduce the data in the index expressly denied such access; (b) temporary work files opened by the national member of their Member State; (c) temporary work files opened by national members of other Member States and to which the national member of their Member States has received access, unless the national member who opened the temporary work file expressly denied such access. 2. The national member shall, within the limitations provided for in paragraph 1 of this Article, decide on the extent of access to the temporary work files which is granted in his or her Member State to the persons referred to in Article 20(3) in so far as they are connected to the case management system. 3. Each Member State shall decide, after consultation with its national member, on the extent of access to the index which is granted in that Member State to the persons referred to in Article 20(3) in so far as they are connected to the case management system. Member States shall notify Eurojust and the Commission of their decision regarding the implementation of this paragraph. The Commission shall inform the other Member States thereof. 4. Persons who have been granted access in accordance with paragraph 2 shall at least have access to the index to the extent necessary to access the temporary work files to which they have been granted access. CHAPTER IV PROCESSING OF INFORMATION Article 26 Processing of personal data by Eurojust 1. This Regulation and Article 3 and Chapter IX of Regulation (EU) 2018/1725 shall apply to the processing of operational personal data by Eurojust. Regulation (EU) 2018/1725 shall apply to the processing of administrative personal data by Eurojust, with the exception of Chapter IX of that Regulation. 2. References to \u2018applicable data protection rules\u2019 in this Regulation shall be understood as references to the provisions on data protection set out in this Regulation and in Regulation (EU) 2018/1725. 3. The data protection rules on processing of operational personal data contained in this Regulation shall be considered as specific data protection rules to the general rules laid down in Article 3 and Chapter IX of Regulation (EU) 2018/1725. 4. Eurojust shall determine the time limits for the storage of administrative personal data in the data protection provisions of its rules of procedure. Article 27 Processing of operational personal data 1. In so far as it is necessary to perform its tasks, Eurojust may, within the framework of its competence and in order to carry out its operational functions, process by automated means or in structured manual files in accordance with this Regulation only the operational personal data listed in point 1 of Annex II of persons who, under the national law of the Member States concerned, are persons with regard to whom there are serious grounds for believing that they have committed or are about to commit a criminal offence in respect of which Eurojust is competent or who have been convicted of such an offence. 2. Eurojust may process only the operational personal data listed in point 2 of Annex II of persons who, under the national law of the Member States concerned, are regarded as victims or other parties to a criminal offence, such as persons who might be called to testify in a criminal investigation or prosecution regarding one or more of the types of crime and the criminal offences referred to in Article 3, persons who are able to provide information on criminal offences, or contacts or associates of a person referred to in paragraph 1. The processing of such operational personal data may only take place if it is necessary for the fulfilment of the tasks of Eurojust, within the framework of its competence and in order to carry out its operational functions. 3. In exceptional cases, for a limited period of time which shall not exceed the time needed for the conclusion of the case in relation to which the data are processed, Eurojust may also process operational personal data other than the personal data referred to in Annex II relating to the circumstances of an offence, where such data are immediately relevant to and are included in ongoing investigations which Eurojust is coordinating or helping to coordinate and when their processing is necessary for the purposes specified in paragraph 1. The Data Protection Officer referred to in Article 36 shall be informed immediately when such operational personal data are processed, and shall be informed of the specific circumstances which justify the necessity of the processing of those operational personal data. Where such other data refer to witnesses or victims within the meaning of paragraph 2 of this Article, the decision to process them shall be taken jointly by the national members concerned. 4. Eurojust may process special categories of operational personal data in accordance with Article 76 of Regulation (EU) 2018/1725. Such data may not be processed in the index referred to in Article 23(4) of this Regulation. Where such other data refer to witnesses or victims within the meaning of paragraph 2 of this Article, the decision to process them shall be taken by the national members concerned. Article 28 Processing under the authority of Eurojust or processor The processor and any person acting under the authority of Eurojust or of the processor who has access to operational personal data shall not process those data except on instructions from Eurojust, unless required to do so by Union law or Member State law. Article 29 Time limits for the storage of operational personal data 1. Operational personal data processed by Eurojust shall be stored by Eurojust for only as long as is necessary for the performance of its tasks. In particular, without prejudice to paragraph 3 of this Article, the operational personal data referred to in Article 27 may not be stored beyond the first applicable date among the following dates: (a) the date on which prosecution is barred under the statute of limitations of all the Member States concerned by the investigation and prosecutions; (b) the date on which Eurojust is informed that the person has been acquitted and the judicial decision became final, in which case the Member State concerned shall inform Eurojust without delay; (c) three years after the date on which the judicial decision of the last of the Member States concerned by the investigation or prosecution became final; (d) the date on which Eurojust and the Member States concerned mutually established or agreed that it was no longer necessary for Eurojust to coordinate the investigation and prosecutions, unless there is an obligation to provide Eurojust with this information in accordance with Article 21(5) or (6); (e) three years after the date on which operational personal data were transmitted in accordance with Article 21(5) or (6). 2. Observance of the storage deadlines referred to in paragraph 1 of this Article shall be reviewed constantly by appropriate automated processing conducted by Eurojust, particularly from the moment in which the case is closed by Eurojust. A review of the need to store the data shall also be carried out every three years after they were entered; the results of such reviews shall apply to the case as a whole. If operational personal data referred to in Article 27(4) are stored for a period exceeding five years, the EDPS shall be informed. 3. Before one of the storage deadlines referred to in paragraph 1 expires, Eurojust shall review the need for the continued storage of the operational personal data where and as long as this is necessary to perform its tasks. It may decide by way of derogation to store those data until the following review. The reasons for the continued storage shall be justified and recorded. If no decision is taken on the continued storage of operational personal data at the time of the review, those data shall be deleted automatically. 4. Where, in accordance with paragraph 3, operational personal data have been stored beyond the storage deadlines referred to in paragraph 1, the EDPS shall also carry out a review of the need to store those data every three years. 5. Once the deadline for the storage of the last item of automated data from the file has expired, all documents in the file shall be destroyed with the exception of any original documents which Eurojust has received from national authorities and which need to be returned to their provider. 6. Where Eurojust has coordinated an investigation or prosecutions, the national members concerned shall inform each other whenever they receive information that the case has been dismissed or that all judicial decisions related to the case have become final. 7. Paragraph 5 shall not apply where: (a) this would damage the interests of a data subject who requires protection; in such cases, the operational personal data shall be used only with the express and written consent of the data subject; (b) the accuracy of the operational personal data is contested by the data subject; in such cases paragraph 5 shall not apply for a period enabling Member States or Eurojust, as appropriate, to verify the accuracy of such data; (c) the operational personal data are to be maintained for purposes of proof or for the establishment, exercise or defence of legal claims; (d) the data subject opposes the erasure of the operational personal data and requests the restriction of their use instead; or (e) the operational personal data are further needed for archiving purposes in the public interest or statistical purposes. Article 30 Security of operational personal data Eurojust and Member States shall define mechanisms to ensure that the security measures referred to in Article 91 of Regulation (EU) 2018/1725 are addressed across information system boundaries. Article 31 Right of access by the data subject 1. Any data subject who wishes to exercise the right of access referred to in Article 80 of Regulation (EU) 2018/1725 to operational personal data that relate to the data subject and which have been processed by Eurojust may make a request to Eurojust or to the national supervisory authority in the Member State of the data subject\u2019s choice. That authority shall refer the request to Eurojust without delay, and in any case within one month of its receipt. 2. The request shall be answered by Eurojust without undue delay and in any case within three months of its receipt by Eurojust. 3. The competent authorities of the Member States concerned shall be consulted by Eurojust on the decision to be taken in response to a request. The decision on access to data shall only be taken by Eurojust in close cooperation with the Member States directly concerned by the communication of such data. Where a Member State objects to Eurojust\u2019s proposed decision, it shall notify Eurojust of the reasons for its objection. Eurojust shall comply with any such objection. The national members concerned shall subsequently notify the competent authorities of the content of Eurojust\u2019s decision. 4. The national members concerned shall deal with the request and reach a decision on Eurojust\u2019s behalf. Where the national members concerned are not in agreement, they shall refer the matter to the College, which shall take its decision on the request by a two-thirds majority. Article 32 Limitations to the right of access In the cases referred to in Article 81 of Regulation (EU) 2018/1725, Eurojust shall inform the data subject after consulting the competent authorities of the Member States concerned in accordance with Article 31(3) of this Regulation. Article 33 Right to restriction of processing Without prejudice to the exceptions set out in Article 29(7) of this Regulation, where the processing of operational personal data has been restricted under Article 82(3) of Regulation (EU) 2018/1725, such operational personal data shall only be processed for the protection of the rights of the data subject or another natural or legal person who is a party to the proceedings to which Eurojust is a party, or for the purposes laid down in Article 82(3) of Regulation (EU) 2018/1725. Article 34 Authorised access to operational personal data within Eurojust Only national members, their deputies, their Assistants and authorised seconded national experts, the persons referred to in Article 20(3) in so far as those persons are connected to the case management system and authorised Eurojust staff may, for the purpose of achieving Eurojust\u2019s tasks, have access to operational personal data processed by Eurojust within the limits provided for in Articles 23, 24 and 25. Article 35 Records of categories of processing activities 1. Eurojust shall maintain a record of all categories of processing activities under its responsibility. That record shall contain all of the following information: (a) Eurojust\u2019s contact details and the name and the contact details of its Data Protection Officer; (b) the purposes of the processing; (c) the description of the categories of data subjects and of the categories of operational personal data; (d) the categories of recipients to whom the operational personal data have been or will be disclosed including recipients in third countries or international organisations; (e) where applicable, transfers of operational personal data to a third country or an international organisation, including the identification of that third country or international organisation; (f) where possible, the envisaged time limits for erasure of the different categories of data; (g) where possible, a general description of the technical and organisational security measures referred to in Article 91 of Regulation (EU) 2018/1725. 2. The records referred to in paragraph 1 shall be in writing, including in electronic form. 3. Eurojust shall make the record available to the EDPS on request. Article 36 Designation of the Data Protection Officer 1. The Executive Board shall designate a Data Protection Officer. The Data Protection Officer shall be a member of staff specifically appointed for this purpose. In the performance of his or her duties, the Data Protection Officer shall act independently and may not receive any instructions. 2. The Data Protection Officer shall be selected on the basis of his or her professional qualities and, in particular, expert knowledge of data protection law and practice, and ability to fulfil his or her tasks under this Regulation, in particular those referred to in Article 38. 3. The selection of the Data Protection Officer shall not be liable to result in a conflict of interests between his or her duty as Data Protection Officer and any other official duties he or she may have, in particular in relation to the application of this Regulation. 4. The Data Protection Officer shall be appointed for a term of four years and shall be eligible for reappointment up to a maximum total term of eight years. The Data Protection Officer may be dismissed from his or her post by the Executive Board only with the agreement of the EDPS, if he or she no longer fulfils the conditions required for the performance of his or her duties. 5. Eurojust shall publish the contact details of the Data Protection Officer and communicate them to the EDPS. Article 37 Position of the Data Protection Officer 1. Eurojust shall ensure that the Data Protection Officer is involved properly and in a timely manner in all issues which relate to the protection of personal data. 2. Eurojust shall support the Data Protection Officer in performing the tasks referred to in Article 38 by providing the resources and staff necessary to carry out those tasks and by providing access to personal data and processing operations, and to maintain his or her expert knowledge. 3. Eurojust shall ensure that the Data Protection Officer does not receive any instructions regarding the carrying out of his or her tasks. The Data Protection Officer shall not be dismissed or penalised by the Executive Board for performing his or her tasks. The Data Protection Officer shall report directly to the College in relation to operational personal data and report to the Executive Board in relation to administrative personal data. 4. Data subjects may contact the Data Protection Officer with regard to all issues related to processing of their personal data and to the exercise of their rights under this Regulation and under Regulation (EU) 2018/1725. 5. The Executive Board shall adopt implementing rules concerning the Data Protection Officer. Those implementing rules shall in particular concern the selection procedure for the position of the Data Protection Officer, his or her dismissal, tasks, duties and powers, and safeguards for the independence of the Data Protection Officer. 6. The Data Protection Officer and his or her staff shall be bound by the obligation of confidentiality in accordance with Article 72. 7. The Data Protection Officer may be consulted by the controller and the processor, by the staff committee concerned and by any individual on any matter concerning the interpretation or application of this Regulation and Regulation (EU) 2018/1725 without them going through the official channels. No one shall suffer prejudice on account of a matter brought to the attention of the Data Protection Officer alleging that a breach of this Regulation or Regulation (EU) 2018/1725 has taken place. 8. After his or her designation the Data Protection Officer shall be registered with the EDPS by Eurojust. Article 38 Tasks of the Data Protection Officer 1. The Data Protection Officer shall in particular have the following tasks regarding the processing of personal data: (a) ensuring in an independent manner the compliance of Eurojust with the data protection provisions of this Regulation and Regulation (EU) 2018/1725 and with the relevant data protection provisions in Eurojust\u2019s rules of procedure; this includes monitoring compliance with this Regulation, with Regulation (EU) 2018/1725, with other Union or national data protection provisions and with the policies of Eurojust in relation to the protection of personal data, including the assignment of responsibilities, awareness-raising and training of staff involved in processing operations, and related audits; (b) informing and advising Eurojust and staff who process personal data of their obligations pursuant to this Regulation, to Regulation (EU) 2018/1725 and to other Union or national data protection provisions; (c) providing advice where requested as regards the data protection impact assessment and monitoring its performance pursuant to Article 89 of Regulation (EU) 2018/1725; (d) ensuring that a record of the transfer and receipt of personal data is kept in accordance with the provisions to be laid down in Eurojust\u2019s rules of procedure; (e) cooperating with the staff of Eurojust who are responsible for procedures, training and advice concerning data processing; (f) cooperating with the EDPS; (g) ensuring that data subjects are informed of their rights under this Regulation and Regulation (EU) 2018/1725; (h) acting as the contact point for the EDPS on issues relating to processing, including the prior consultation referred to in Article 90 of Regulation (EU) 2018/1725, and consulting where appropriate, with regard to any other matter; (i) providing advice where requested as regards the necessity of a notification or communication of a personal data breach pursuant to Articles 92 and 93 of Regulation (EU) 2018/1725; (j) preparing an annual report and communicating that report to the Executive Board, to the College and to the EDPS. 2. The Data Protection Officer shall carry out the functions provided for in Regulation (EU) 2018/1725 with regard to administrative personal data. 3. The Data Protection Officer and the staff members of Eurojust assisting the Data Protection Officer in the performance of his or her duties shall have access to the personal data processed by Eurojust and to its premises, to the extent necessary for the performance of their tasks. 4. If the Data Protection Officer considers that the provisions of Regulation (EU) 2018/1725 related to the processing of administrative personal data or that the provisions of this Regulation or of Article 3 and of Chapter IX of Regulation (EU) 2018/1725 related to the processing of operational personal data have not been complied with, he or she shall inform the Executive Board, requesting that it resolve the non-compliance within a specified time. If the Executive Board does not resolve the non-compliance within the specified time, the Data Protection Officer shall refer the matter to the EDPS. Article 39 Notification of a personal data breach to the authorities concerned 1. In the event of a personal data breach, Eurojust shall without undue delay notify the competent authorities of the Member States concerned of that breach. 2. The notification referred to in paragraph 1 shall, as a minimum: (a) describe the nature of the personal data breach including, where possible and appropriate, the categories and number of data subjects concerned and the categories and number of data records concerned; (b) describe the likely consequences of the personal data breach; (c) describe the measures proposed or taken by Eurojust to address the personal data breach; and (d) where appropriate, recommend measures to mitigate the possible adverse effects of the personal data breach. Article 40 Supervision by the EDPS 1. The EDPS shall be responsible for monitoring and ensuring the application of the provisions of this Regulation and Regulation (EU) 2018/1725 relating to the protection of fundamental rights and freedoms of natural persons with regard to processing of operational personal data by Eurojust, and for advising Eurojust and data subjects on all matters concerning the processing of operational personal data. To that end, the EDPS shall fulfil the duties set out in paragraph 2 of this Article, shall exercise the powers granted in paragraph 3 of this Article and shall cooperate with the national supervisory authorities in accordance with Article 42. 2. The EDPS shall have the following duties under this Regulation and Regulation (EU) 2018/1725: (a) hearing and investigating complaints, and informing the data subject of the outcome within a reasonable period; (b) conducting inquiries either on his or her own initiative or on the basis of a complaint, and informing the data subjects of the outcome within a reasonable period; (c) monitoring and ensuring the application of the provisions of this Regulation and Regulation (EU) 2018/1725 relating to the protection of natural persons with regard to the processing of operational personal data by Eurojust; (d) advising Eurojust, either on his or her own initiative or in response to a consultation, on all matters concerning the processing of operational personal data, in particular before Eurojust draws up internal rules relating to the protection of fundamental rights and freedoms with regard to the processing of operational personal data. 3. The EDPS may under this Regulation and Regulation (EU) 2018/1725, taking into account the implications for investigations and prosecutions in the Member States: (a) give advice to data subjects on the exercise of their rights; (b) refer a matter to Eurojust in the event of an alleged breach of the provisions governing the processing of operational personal data, and, where appropriate, make proposals for remedying that breach and for improving the protection of the data subjects; (c) consult Eurojust where requests to exercise certain rights in relation to operational personal data have been refused in breach of Article 31, 32 or 33 of this Regulation or Articles 77 to 82 or Article 84 of Regulation (EU) 2018/1725; (d) warn Eurojust; (e) order Eurojust to carry out the rectification, restriction or erasure of operational personal data which have been processed by Eurojust in breach of the provisions governing the processing of operational personal data and to notify such actions to third parties to whom such data have been disclosed, provided that this does not interfere with the tasks of Eurojust set out in Article 2; (f) refer the matter to the Court of Justice of the European Union (the \u2018Court\u2019) under the conditions set out in the TFEU; (g) intervene in actions brought before the Court. 4. The EDPS shall have access to the operational personal data processed by Eurojust and to its premises to the extent necessary for the performance of his or her tasks. 5. The EDPS shall draw up an annual report on his or her supervisory activities in relation to Eurojust. That report shall be part of the annual report of the EDPS referred to in Article 60 of Regulation (EU) 2018/1725. The national supervisory authorities shall be invited to make observations on this report before it becomes part of the annual report of the EDPS referred to in Article 60 of Regulation (EU) 2018/1725. The EDPS shall take utmost account of the observations made by national supervisory authorities and, in any case, shall refer to them in the annual report. 6. Eurojust shall cooperate with the EDPS in the performance of his or her tasks at his or her request. Article 41 Professional secrecy of the EDPS 1. The EDPS and his or her staff shall, both during and after their term of office, be subject to a duty of professional secrecy with regard to any confidential information which has come to their knowledge in the course of their performance of official duties. 2. The EDPS shall, in the exercise of his or her supervision powers, take into utmost account the secrecy of judicial inquiries and criminal proceedings, in accordance with Union or Member State law. Article 42 Cooperation between the EDPS and national supervisory authorities 1. The EDPS shall act in close cooperation with national supervisory authorities with respect to specific issues requiring national involvement, in particular if the EDPS or a national supervisory authority finds major discrepancies between practices of the Member States or potentially unlawful transfers using Eurojust\u2019s communication channels, or in the context of questions raised by one or more national supervisory authorities on the implementation and interpretation of this Regulation. 2. In the cases referred to in paragraph 1, coordinated supervision shall be ensured in accordance with Article 62 of Regulation (EU) 2018/1725. 3. The EDPS shall keep national supervisory authorities fully informed of all issues that directly affect them or are otherwise relevant to them. Upon a request from one or more national supervisory authorities, the EDPS shall inform them on specific issues. 4. In cases relating to data originating from one or several Member States, including cases referred to in Article 43(3), the EDPS shall consult the national supervisory authorities concerned. The EDPS shall not decide on further action to be taken before those national supervisory authorities have informed the EDPS of their position, within a deadline specified by the EDPS. That deadline shall not be shorter than one month or longer than three months. The EDPS shall take utmost account of the position of the national supervisory authorities concerned. In cases where the EDPS intends not to follow their position, he or she shall inform them, provide a justification, and submit the matter to the European Data Protection Board. In cases which the EDPS considers to be extremely urgent, he or she may decide to take immediate action. In such cases, the EDPS shall immediately inform the national supervisory authorities concerned and substantiate the urgent nature of the situation and justify the action he or she has taken. 5. National supervisory authorities shall keep the EDPS informed of any actions they take with respect to the transfer, retrieval, or any other communication of operational personal data under this Regulation by the Member States. Article 43 Right to lodge a complaint with the EDPS with respect to operational personal data 1. Any data subject shall have the right to lodge a complaint with the EDPS, if he or she considers that the processing by Eurojust of operational personal data relating to him or her does not comply with this Regulation or Regulation (EU) 2018/1725. 2. Where a complaint relates to a decision referred to in Article 31, 32 or 33 of this Regulation or Article 80, 81 or 82 of Regulation (EU) 2018/1725, the EDPS shall consult the national supervisory authorities or the competent judicial body of the Member State that provided the data or the Member State directly concerned. In adopting his or her decision, which may extend to a refusal to communicate any information, the EDPS shall take into account the opinion of the national supervisory authority or of the competent judicial body. 3. Where a complaint relates to the processing of data provided by a Member State to Eurojust, the EDPS and the national supervisory authority of the Member State that provided the data, each acting within the scope of their respective competences shall ensure that the necessary checks on the lawfulness of the processing of the data have been carried out correctly. 4. Where a complaint relates to the processing of data provided to Eurojust by Union bodies, offices or agencies, by third countries or by international organisations or to the processing of data retrieved by Eurojust from publicly available sources, the EDPS shall ensure that Eurojust has correctly carried out the necessary checks on the lawfulness of the processing of the data. 5. The EDPS shall inform the data subject of the progress and outcome of the complaint, as well as the possibility of a judicial remedy pursuant to Article 44. Article 44 Right to judicial review against the EDPS Actions against the decisions of the EDPS concerning operational personal data shall be brought before the Court. Article 45 Responsibility in data protection matters 1. Eurojust shall process operational personal data in such a way that it can be established which authority provided the data or from where the data were retrieved. 2. Responsibility for the accuracy of operational personal data shall lie with: (a) Eurojust for operational personal data provided by a Member State, or by a Union institution, body, office or agency where the data provided has been altered in the course of processing by Eurojust; (b) the Member State or the Union institution, office, body or agency which provided the data to Eurojust, where the data provided has not been altered in the course of processing by Eurojust; (c) Eurojust for operational personal data provided by third countries or by international organisations, as well for operational personal data retrieved by Eurojust from publicly available sources. 3. Responsibility for compliance with Regulation (EU) 2018/1725 in relation to administrative personal data and for compliance with this Regulation and with Article 3 and Chapter IX of Regulation (EU) 2018/1725 in relation to operational personal data shall lie with Eurojust. Responsibility for the legality of a transfer of operational personal data shall lie: (a) where a Member State has provided the operational personal data concerned to Eurojust, with that Member State; (b) with Eurojust, where it has provided the operational personal data concerned to Member States, to Union institutions, bodies, offices or agencies, to third countries or to international organisations. 4. Subject to other provisions of this Regulation, Eurojust shall be responsible for all data processed by it. Article 46 Liability for unauthorised or incorrect processing of data 1. Eurojust shall be liable, in accordance with Article 340 TFEU, for any damage caused to an individual which results from the unauthorised or incorrect processing of data carried out by it. 2. Complaints against Eurojust on grounds of the liability referred to in paragraph 1 of this Article shall be heard by the Court in accordance with Article 268 TFEU. 3. Each Member State shall be liable, in accordance with its national law, for any damage caused to an individual which results from the unauthorised or incorrect processing carried out by it of data which were communicated to Eurojust. CHAPTER V RELATIONS WITH PARTNERS SECTION I Common provisions Article 47 Common provisions 1. In so far as necessary for the performance of its tasks, Eurojust may establish and maintain cooperative relations with Union institutions, bodies, offices and agencies in accordance with their respective objectives, and with the competent authorities of third countries and international organisations in accordance with the cooperation strategy referred to in Article 52. 2. In so far as relevant to the performance of its tasks and subject to any restrictions pursuant to Article 21(8) and Article 76, Eurojust may exchange any information with the entities referred to in paragraph 1 of this Article directly, with the exception of personal data. 3. For the purposes set out in paragraphs 1 and 2, Eurojust may conclude working arrangements with the entities referred to in paragraph 1. Such working arrangements shall not form the basis for allowing the exchange of personal data and shall not bind the Union or its Member States. 4. Eurojust may receive and process personal data received from the entities referred to in paragraph 1 in so far as necessary for the performance of its tasks, subject to the applicable data protection rules. 5. Personal data shall only be transferred by Eurojust to Union institutions, bodies, offices or agencies, to third countries or to international organisations if this is necessary for the performance of its tasks and is in accordance with Articles 55 and 56. If the data to be transferred have been provided by a Member State, Eurojust shall obtain the consent of the relevant competent authority in that Member State, unless the Member State has granted its prior authorisation to such onward transfer, either in general terms or subject to specific conditions. Such consent may be withdrawn at any time. 6. Where Member States, Union institutions, bodies, offices or agencies, third countries or international organisations have received personal data from Eurojust, onward transfers of such data to third parties shall be prohibited unless all of the following conditions have been met: (a) Eurojust has obtained prior consent from the Member State that provided the data; (b) Eurojust has given its explicit consent after considering the circumstances of the case at hand; (c) the onward transfer is only for a specific purpose that is not incompatible with the purpose for which the data were transmitted. SECTION II Relations with partners within the Union Article 48 Cooperation with the European Judicial Network and other Union networks involved in judicial cooperation in criminal matters 1. Eurojust and the European Judicial Network in criminal matters shall maintain privileged relations with each other, based on consultation and complementarity, especially between the national member, contact points of the European Judicial Network in the same Member State as the national member, and the national correspondents for Eurojust and the European Judicial Network. In order to ensure efficient cooperation, the following measures shall be taken: (a) on a case-by-case basis national members shall inform the contact points of the European Judicial Network of all cases which they consider the Network to be in a better position to deal with; (b) the Secretariat of the European Judicial Network shall form part of the staff of Eurojust; it shall function as a separate unit; it may draw on the administrative resources of Eurojust which are necessary for the performance of the European Judicial Network\u2019s tasks, including for covering the costs of the plenary meetings of the Network; (c) contact points of the European Judicial Network may be invited on a case-by-case basis to attend Eurojust meetings; (d) Eurojust and the European Judicial Network may make use of the Eurojust national coordination system when determining under point (b) of Article 20(7) whether a request should be handled with the assistance of Eurojust or the European Judicial Network. 2. The Secretariat of the Network for joint investigation teams and the Secretariat of the Network set up by Decision 2002/494/JHA shall form part of the staff of Eurojust. Those secretariats shall function as separate units. They may draw on the administrative resources of Eurojust which are necessary for the performance of their tasks. The coordination of the secretariats shall be ensured by Eurojust. This paragraph applies to the secretariat of any relevant network involved in judicial cooperation in criminal matters for which Eurojust is to provide support in the form of a secretariat. Eurojust may support relevant European networks and bodies involved in judicial cooperation in criminal matters, including where appropriate by means of a secretariat hosted at Eurojust. 3. The network set up by Decision 2008/852/JHA may request that Eurojust provide a secretariat of the network. If such request is made, paragraph 2 shall apply. Article 49 Relations with Europol 1. Eurojust shall take all appropriate measures to enable Europol, within Europol\u2019s mandate, to have indirect access, on the basis of a hit/no-hit system, to information provided to Eurojust, without prejudice to any restrictions indicated by the Member State, Union body, office or agency, third country or international organisation that provided the information in question. In the case of a hit, Eurojust shall initiate the procedure by which the information that generated the hit may be shared in accordance with the decision of the Member State, Union body, office or agency, third country or international organisation that provided the information to Eurojust. 2. Searches of information in accordance with paragraph 1 shall be carried out only for the purpose of identifying whether information available at Europol matches with information processed at Eurojust. 3. Eurojust shall allow searches in accordance with paragraph 1 only after obtaining from Europol information on which Europol staff members have been designated as authorised to perform such searches. 4. If during Eurojust\u2019s information processing activities in respect of an individual investigation, Eurojust or a Member State identifies the need for coordination, cooperation or support in accordance with Europol\u2019s mandate, Eurojust shall notify Europol thereof and shall initiate the procedure for sharing the information, in accordance with the decision of the Member State that provided the information. In such cases Eurojust shall consult with Europol. 5. Eurojust shall establish and maintain close cooperation with Europol to the extent relevant to performing the tasks of the two agencies and to achieving their objectives, taking account of the need to avoid duplication of effort. To that end, the Executive Director of Europol and the President of Eurojust shall meet on a regular basis to discuss issues of common concern. 6. Europol shall respect any restriction of access or use, whether in general or specific terms, that has been indicated by a Member State, Union body, office or agency, third country or international organisation, in relation to information that it has provided. Article 50 Relations with the EPPO 1. Eurojust shall establish and maintain a close relationship with the EPPO based on mutual cooperation within their respective mandates and competences and on the development of operational, administrative and management links between them as defined in this Article. To that end, the President of Eurojust and the European Chief Prosecutor shall meet on a regular basis to discuss issues of common interest. They shall meet at the request of the President of Eurojust or of the European Chief Prosecutor. 2. Eurojust shall treat requests for support from the EPPO without undue delay, and, where appropriate, shall treat such requests as if they had been received from a national authority competent for judicial cooperation. 3. Whenever necessary to support the cooperation established in accordance with paragraph 1 of this Article, Eurojust shall make use of the Eurojust national coordination system set up in accordance with Article 20, as well as the relations it has established with third countries, including its liaison magistrates 4. In operational matters relevant to the EPPO\u2019s competences, Eurojust shall inform the EPPO of and, where appropriate, associate it with its activities concerning cross-border cases, including by: (a) sharing information on its cases, including personal data, in accordance with the relevant provisions in this Regulation; (b) requesting the EPPO to provide support. 5. Eurojust shall have indirect access to information in the EPPO\u2019s case management system on the basis of a hit/no-hit system. Whenever a match is found between data entered into the case management system by the EPPO and data held by Eurojust, the fact that there is a match shall be communicated to both Eurojust and to the EPPO, as well as to the Member State which provided the data to Eurojust. Eurojust shall take appropriate measures to enable the EPPO to have indirect access to information in its case management system on the basis of a hit/no-hit system. 6. The EPPO may rely on the support and resources of the administration of Eurojust. To that end, Eurojust may provide services of common interest to the EPPO. The details shall be regulated by an arrangement. Article 51 Relations with other Union bodies, offices and agencies 1. Eurojust shall establish and maintain cooperative relations with the European Judicial Training Network. 2. OLAF shall contribute to Eurojust\u2019s coordination work regarding the protection of the financial interests of the Union, in accordance with its mandate under Regulation (EU, Euratom) No 883/2013. 3. The European Border and Coast Guard Agency shall contribute to Eurojust\u2019s work including by transmitting relevant information processed in accordance with its mandate and tasks under point (m) of Article 8(1) of Regulation (EU) 2016/1624 of the European Parliament and of the Council (21). The European Border and Coast Guard Agency\u2019s processing of any personal data in connection therewith shall be regulated by Regulation (EU) 2018/1725. 4. For the purposes of receiving and transmitting information between Eurojust and OLAF, without prejudice to Article 8 of this Regulation, Member States shall ensure that the national members of Eurojust are regarded as competent authorities of the Member States solely for the purposes of Regulation (EU, Euratom) No 883/2013. The exchange of information between OLAF and national members shall be without prejudice to obligations to provide the information to other competent authorities under those Regulations. SECTION III International cooperation Article 52 Relations with the authorities of third countries and international organisations 1. Eurojust may establish and maintain cooperation with authorities of third countries and international organisations. To that end, Eurojust shall prepare a cooperation strategy every four years in consultation with the Commission, which specifies the third countries and international organisations with which there is an operational need for cooperation. 2. Eurojust may conclude working arrangements with the entities referred to in Article 47(1). 3. Eurojust may designate contact points in third countries in agreement with the competent authorities concerned, in order to facilitate cooperation in accordance with the operational needs of Eurojust. Article 53 Liaison magistrates posted to third countries 1. For the purpose of facilitating judicial cooperation with third countries in cases in which Eurojust is providing assistance in accordance with this Regulation, the College may post liaison magistrates to a third country subject to the existence of a working arrangement as referred to in Article 47(3) with the competent authorities of that third country. 2. The tasks of the liaison magistrates shall include any activity designed to encourage and accelerate any form of judicial cooperation in criminal matters, in particular by establishing direct links with the competent authorities of the third country concerned. In the performance of their tasks, the liaison magistrates may exchange operational personal data with the competent authorities of the third country concerned in accordance with Article 56. 3. The liaison magistrate referred to in paragraph 1 shall have experience of working with Eurojust and adequate knowledge of judicial cooperation and how Eurojust operates. The posting of a liaison magistrate on behalf of Eurojust shall be subject to the prior consent of the magistrate and of his or her Member State. 4. Where the liaison magistrate posted by Eurojust is selected among national members, deputies or Assistants: (a) the Member State concerned shall replace him or her in his or her function as a national member, deputy or Assistant; (b) he or she shall cease to be entitled to exercise the powers granted to him or her under Article 8. 5. Without prejudice to Article 110 of the Staff Regulations of Officials, the College shall draw up the terms and conditions for the posting of liaison magistrates, including their level of remuneration. The College shall adopt the necessary implementing arrangements in this respect in consultation with the Commission. 6. The activities of liaison magistrates posted by Eurojust shall be subject to the supervision of the EDPS. The liaison magistrates shall report to the College, which shall inform the European Parliament and the Council in the annual report and in an appropriate manner of their activities. The liaison magistrates shall inform national members and competent national authorities of all cases concerning their Member State. 7. The competent authorities of the Member States and liaison magistrates referred to in paragraph 1 may contact each other directly. In such cases, the liaison magistrate shall inform the national member concerned of such contacts. 8. The liaison magistrates referred to in paragraph 1 shall be connected to the case management system. Article 54 Requests for judicial cooperation to and from third countries 1. Eurojust may, with the agreement of the Member States concerned, coordinate the execution of requests for judicial cooperation issued by a third country where such requests require execution in at least two Member States as part of the same investigation. Such requests may also be transmitted to Eurojust by a competent national authority. 2. In urgent cases and in accordance with Article 19, the OCC may receive and transmit the requests referred to in paragraph 1 of this Article if they have been issued by a third country which has concluded a cooperation agreement or working arrangement with Eurojust. 3. Without prejudice to Article 3(5), where requests for judicial cooperation which relate to the same investigation and which require execution in a third country are made by the Member State concerned, Eurojust shall facilitate judicial cooperation with that third country. SECTION IV Transfers of personal data Article 55 Transmission of operational personal data to Union institutions, bodies, offices and agencies 1. Subject to any further restrictions pursuant to this Regulation, in particular pursuant to Articles 21(8), 47(5) and 76, Eurojust shall only transmit operational personal data to another Union institution, body, office or agency if the data are necessary for the legitimate performance of tasks covered by the competence of the other Union institution, body, office or agency. 2. Where the operational personal data are transmitted following a request from another Union institution, body, office or agency, both the controller and the recipient shall bear the responsibility for the legitimacy of that transfer. Eurojust shall be required to verify the competence of the other Union institution, body, office or agency and to make a provisional evaluation of the necessity of the transmission of the operational personal data. If doubts arise as to this necessity, Eurojust shall seek further information from the recipient. The other Union institution, body, office or agency shall ensure that the necessity of the transmission of the operational personal data can be subsequently verified. 3. The other Union institution, body, office or agency shall process the operational personal data only for the purposes for which they were transmitted. Article 56 General principles for transfers of operational personal data to third countries and international organisations 1. Eurojust may transfer operational personal data to a third country or international organisation, subject to compliance with the applicable data protection rules and the other provisions of this Regulation, and only where the following conditions are met: (a) the transfer is necessary for the performance of Eurojust\u2019s tasks; (b) the authority of the third country or the international organisation to which the operational personal data are transferred is competent in law enforcement and criminal matters; (c) where the operational personal data to be transferred in accordance with this Article have been transmitted or made available to Eurojust by a Member State, Eurojust shall obtain prior authorisation for the transfer from the relevant competent authority of that Member State in compliance with its national law, unless that Member State has authorised such transfers in general terms or subject to specific conditions; (d) in the case of an onward transfer to another third country or international organisation by a third country or international organisation, Eurojust shall require the transferring third country or international organisation to obtain the prior authorisation of Eurojust for that onward transfer. Eurojust shall only provide authorisation under point (d) with the prior authorisation of the Member State from which the data originate after taking due account of all relevant factors, including the seriousness of the criminal offence, the purpose for which the operational personal data were originally transferred and the level of personal data protection in the third country or international organisation to which the operational personal data are to be transferred onward. 2. Subject to the conditions set out in paragraph 1 of this Article, Eurojust may transfer operational personal data to a third country or to an international organisation only where one of the following applies: (a) the Commission has decided pursuant to Article 57 that the third country or international organisation in question ensures an adequate level of protection, or in the absence of such an adequacy decision, appropriate safeguards have been provided for or exist in accordance with Article 58(1), or in the absence of both an adequacy decision and of such appropriate safeguards, a derogation for specific situations applies pursuant to Article 59(1); (b) a cooperation agreement allowing for the exchange of operational personal data has been concluded before 12 December 2019 between Eurojust and that third country or international organisation, in accordance with Article 26a of Decision 2002/187/JHA; or (c) an international agreement has been concluded between the Union and the third country or international organisation pursuant to Article 218 TFEU that provides for adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals. 3. The working arrangements referred to in Article 47(3) may be used to set out modalities to implement the agreements or adequacy decisions referred to in paragraph 2 of this Article. 4. Eurojust may in urgent cases transfer operational personal data without prior authorisation from a Member State in accordance with point (c) of paragraph 1. Eurojust shall only do so if the transfer of the operational personal data is necessary for the prevention of an immediate and serious threat to the public security of a Member State or of a third country or to the essential interests of a Member State, and where the prior authorisation cannot be obtained in good time. The authority responsible for giving prior authorisation shall be informed without delay. 5. Member States and Union institutions, bodies, offices and agencies shall not transfer operational personal data they have received from Eurojust onward to a third country or an international organisation,. As an exception, they may make such a transfer in cases where Eurojust has authorised it after taking into due account all relevant factors, including the seriousness of the criminal offence, the purpose for which the operational personal data were originally transmitted and the level of personal data protection in the third country or international organisation to which the operational personal data are transferred onward. 6. Articles 57, 58 and 59 shall apply in order to ensure that the level of protection of natural persons ensured by this Regulation and by Union law is not undermined. Article 57 Transfers on the basis of an adequacy decision Eurojust may transfer operational personal data to a third country or to an international organisation where the Commission has decided in accordance with Article 36 of Directive (EU) 2016/680 that the third country, a territory or one or more specified sectors within that third country, or the international organisation in question ensures an adequate level of protection. Article 58 Transfers subject to appropriate safeguards 1. In the absence of an adequacy decision, Eurojust may transfer operational personal data to a third country or an international organisation where: (a) appropriate safeguards with regard to the protection of operational personal data are provided for in a legally binding instrument; or (b) Eurojust has assessed all the circumstances surrounding the transfer of operational personal data and has concluded that appropriate safeguards exist with regard to the protection of operational personal data. 2. Eurojust shall inform the EDPS about categories of transfers under point (b) of paragraph 1. 3. When a transfer is based on point (b) of paragraph 1, such a transfer shall be documented and the documentation shall be made available to the EDPS on request. The documentation shall include a record of the date and time of the transfer and information about the receiving competent authority, about the justification for the transfer and about the operational personal data transferred. Article 59 Derogations for specific situations 1. In the absence of an adequacy decision, or of appropriate safeguards pursuant to Article 58, Eurojust may transfer operational personal data to a third country or an international organisation only on the condition that the transfer is necessary: (a) in order to protect the vital interests of the data subject or another person; (b) to safeguard legitimate interests of the data subject; (c) for the prevention of an immediate and serious threat to public security of a Member State or a third country; or (d) in individual cases for the performance of the tasks of Eurojust, unless Eurojust determines that the fundamental rights and freedoms of the data subject concerned override the public interest in the transfer. 2. Where a transfer is based on paragraph 1, such a transfer shall be documented and the documentation shall be made available to the EDPS on request. The documentation shall include a record of the date and time of the transfer, and information about the receiving competent authority, about the justification for the transfer and about the operational personal data transferred. CHAPTER VI FINANCIAL PROVISIONS Article 60 Budget 1. Estimates of all the revenue and expenditure of Eurojust shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in Eurojust\u2019s budget. 2. Eurojust\u2019s budget shall be balanced in terms of revenue and of expenditure. 3. Without prejudice to other resources, Eurojust\u2019s revenue shall comprise: (a) a contribution from the Union entered in the general budget of the Union; (b) any voluntary financial contribution from the Member States; (c) charges for publications and any service provided by Eurojust; (d) ad hoc grants. 4. The expenditure of Eurojust shall include staff remuneration, administrative and infrastructure expenses and operating costs, including funding for joint investigation teams. Article 61 Establishment of the budget 1. Each year the Administrative Director shall draw up a draft statement of estimates of Eurojust\u2019s revenue and expenditure for the following financial year, including the establishment plan, and shall send it to the Executive Board. The European Judicial Network and other Union networks involved in judicial cooperation in criminal matters referred to in Article 48 shall be informed of the parts related to their activities in due time before the estimate is forwarded to the Commission. 2. The Executive Board shall, on the basis of the draft statement of estimates, review the provisional draft estimate of Eurojust\u2019s revenue and expenditure for the following financial year, which it shall forward to the College for adoption. 3. The provisional draft estimate of Eurojust\u2019s revenue and expenditure shall be sent to the Commission by no later than 31 January each year. Eurojust shall send the final draft estimate, which shall include a draft establishment plan, to the Commission by 31 March of the same year. 4. The Commission shall send the statement of estimates to the European Parliament and to the Council (the \u2018budgetary authority\u2019) together with the draft general budget of the Union. 5. On the basis of the statement of estimates, the Commission shall enter in the draft general budget of the Union the estimates it considers necessary for the establishment plan and the amount of the contribution to be charged to the general budget, which it shall place before the budgetary authority in accordance with Articles 313 and 314 TFEU. 6. The budgetary authority shall authorise the appropriations for the contribution from the Union to Eurojust. 7. The budgetary authority shall adopt Eurojust\u2019s establishment plan. Eurojust\u2019s budget shall be adopted by the College. It shall become final following the final adoption of the general budget of the Union. Where necessary, Eurojust\u2019s budget shall be adjusted by the College accordingly. 8. Article 88 of Commission Delegated Regulation (EU) No 1271/2013 (22) shall apply to any building project likely to have significant implications for Eurojust\u2019s budget. Article 62 Implementation of the budget The Administrative Director shall act as the authorising officer of Eurojust and shall implement Eurojust\u2019s budget under his or her own responsibility, within the limits authorised in the budget. Article 63 Presentation of accounts and discharge 1. Eurojust\u2019s accounting officer shall send the provisional accounts for the financial year (year N) to the Commission\u2019s Accounting Officer and to the Court of Auditors by 1 March of the following financial year (year N + 1). 2. Eurojust shall send the report on the budgetary and financial management for year N to the European Parliament, the Council and the Court of Auditors by 31 March of year N + 1. 3. The Commission\u2019s Accounting Officer shall send Eurojust\u2019s provisional accounts for year N, consolidated with the Commission\u2019s accounts, to the Court of Auditors by 31 March of year N + 1. 4. In accordance with Article 246(1) of Regulation (EU, Euratom) 2018/1046, the Court of Auditors shall make its observations on Eurojust\u2019s provisional accounts by 1 June of year N + 1. 5. On receipt of the Court of Auditors\u2019 observations on Eurojust\u2019s provisional accounts pursuant to Article 246 of Regulation (EU, Euratom) 2018/1046, the Administrative Director shall draw up Eurojust\u2019s final accounts under his or her own responsibility and shall submit them to the Executive Board for an opinion. 6. The Executive Board shall deliver an opinion on Eurojust\u2019s final accounts. 7. The Administrative Director shall, by 1 July of year N + 1, send the final accounts for year N to the European Parliament, to the Council, to the Commission and to the Court of Auditors, together with the Executive Board\u2019s opinion. 8. The final accounts for year N shall be published in the Official Journal of the European Union by 15 November of year N + 1. 9. The Administrative Director shall send the Court of Auditors a reply to its observations by 30 September of year N + 1. The Administrative Director shall also send this reply to the Executive Board and to the Commission. 10. At the European Parliament\u2019s request, the Administrative Director shall submit to it any information required for the smooth application of the discharge procedure for the financial year in question in accordance with Article 261(3) of Regulation (EU, Euratom) 2018/1046. 11. On a recommendation from the Council acting by a qualified majority, the European Parliament shall, before 15 May of year N + 2, grant a discharge to the Administrative Director in respect of the implementation of the budget for year N. 12. The discharge of Eurojust\u2019s budget shall be granted by the European Parliament on a recommendation of the Council following a procedure comparable to that provided for in Article 319 TFEU and Articles 260, 261 and 262 of Regulation (EU, Euratom) 2018/1046, and based on the audit report of the Court of Auditors. If the European Parliament refuses to grant the discharge by 15 May of year N + 2, the Administrative Director shall be invited to explain his or her position to the College, which shall take its final decision on the position of the Administrative Director in light of the circumstances. Article 64 Financial rules 1. The financial rules applicable to Eurojust shall be adopted by the Executive Board in accordance with Delegated Regulation (EU) No 1271/2013 after consultation with the Commission. Those financial rules shall not depart from Delegated Regulation (EU) No 1271/2013 unless such departure is specifically required for Eurojust\u2019s operation and the Commission has given its prior consent. In respect of the financial support to be given to joint investigation teams\u2019 activities, Eurojust and Europol shall jointly establish the rules and conditions upon which applications for such support are to be processed. 2. Eurojust may award grants related to the fulfilment of its tasks under Article 4(1). Grants provided for tasks relating to point (f) of Article 4(1) may be awarded to the Member States without a call for proposals. CHAPTER VII STAFF PROVISIONS Article 65 General provisions 1. The Staff Regulations of Officials and the Conditions of Employment of Other Servants, as well as the rules adopted by agreement between the institutions of the Union for giving effect to the Staff Regulations of Officials and the Conditions of Employment of Other Servants shall apply to the staff of Eurojust. 2. Eurojust staff shall consist of staff recruited according to the rules and regulations applicable to officials and other servants of the Union, taking into account all the criteria referred to in Article 27 of the Staff Regulations of Officials, including their geographical distribution. Article 66 Seconded national experts and other staff 1. In addition to its own staff, Eurojust may make use of seconded national experts or other staff not employed by Eurojust. 2. The College shall adopt a decision laying down rules on the secondment of national experts to Eurojust and on the use of other staff, in particular to avoid potential conflicts of interest. 3. Eurojust shall take appropriate administrative measures, inter alia, through training and prevention strategies, to avoid conflicts of interest, including conflicts of interests relating to post-employment issues. CHAPTER VIII EVALUATION AND REPORTING Article 67 Involvement of the Union institutions and national parliaments 1. Eurojust shall transmit its annual report to the European Parliament, to the Council and to national parliaments, which may present observations and conclusions. 2. Upon his or her election, the newly elected President of Eurojust shall make a statement before the competent committee or committees of the European Parliament and answer questions put by its members. Discussions shall not refer directly or indirectly to concrete actions taken in relation to specific operational cases. 3. The President of Eurojust shall appear once a year for the joint evaluation of the activities of Eurojust by the European Parliament and national parliaments within the framework of an interparliamentary committee meeting, to discuss Eurojust\u2019s current activities and to present its annual report or other key documents of Eurojust. Discussions shall not refer directly or indirectly to concrete actions taken in relation to specific operational cases. 4. In addition to the other obligations of information and consultation set out in this Regulation, Eurojust shall transmit to the European Parliament and to national parliaments in their respective official languages for their information: (a) the results of studies and strategic projects elaborated or commissioned by Eurojust; (b) the programming document referred to in Article 15; (c) working arrangements concluded with third parties. Article 68 Opinions on proposed legislative acts The Commission and the Member States exercising their rights on the basis of point (b) of Article 76 TFEU may request Eurojust\u2019s opinion on all proposed legislative acts referred to in Article 76 TFEU. Article 69 Evaluation and review 1. By 13 December 2024, and every 5 years thereafter, the Commission shall commission an evaluation of the implementation and impact of this Regulation, and the effectiveness and efficiency of Eurojust and its working practices. The College shall be heard in the evaluation. The evaluation may, in particular, address the possible need to modify the mandate of Eurojust, and the financial implications of any such modification. 2. The Commission shall forward the evaluation report together with its conclusions to the European Parliament, to national parliaments, to the Council and to the College. The findings of the evaluation shall be made public. CHAPTER IX GENERAL AND FINAL PROVISIONS Article 70 Privileges and immunities Protocol No 7 on the privileges and immunities of the European Union, annexed to the TEU and to the TFEU, shall apply to Eurojust and its staff. Article 71 Language arrangements 1. Council Regulation No 1 (23) shall apply to Eurojust. 2. The College shall decide Eurojust\u2019s internal language arrangements by a two-thirds majority of its members. 3. The translation services required for the functioning of Eurojust shall be provided by the Translation Centre for the bodies of the European Union, as established by Council Regulation (EC) No 2965/94 (24), unless the unavailability of the Translation Centre requires another solution to be found. Article 72 Confidentiality 1. The national members and their deputies and Assistants referred to in Article 7, Eurojust staff, national correspondents, seconded national experts, liaison magistrates, the Data Protection Officer, and the members and staff of the EDPS shall be bound by an obligation of confidentiality with respect to any information which has come to their knowledge in the course of the performance of their tasks. 2. The obligation of confidentiality shall apply to all persons and to all bodies that work with Eurojust. 3. The obligation of confidentiality shall also apply after leaving office or employment and after the termination of the activities of the persons referred to in paragraphs 1 and 2. 4. The obligation of confidentiality shall apply to all information received or exchanged by Eurojust, unless that information has already lawfully been made public or is accessible to the public. Article 73 Conditions of confidentiality of national proceedings 1. Without prejudice to Article 21(3), where information is received or exchanged via Eurojust, the authority of the Member State which provided the information may stipulate conditions, pursuant to its national law, on the use by the receiving authority of that information in national proceedings. 2. The authority of the Member State which receives the information referred to in paragraph 1 shall be bound by those conditions. Article 74 Transparency 1. Regulation (EC) No 1049/2001 of the European Parliament and the Council (25) shall apply to documents held by Eurojust. 2. The Executive Board shall, within six months of the date of its first meeting, prepare the detailed rules for applying Regulation (EC) No 1049/2001 for adoption by the College. 3. Decisions taken by Eurojust under Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the European Ombudsman or of an action before the Court, under the conditions laid down in Articles 228 and 263 TFEU respectively. 4. Eurojust shall publish on its website a list of the Executive Board members and summaries of the outcome of the meetings of the Executive Board. The publication of those summaries shall be temporarily or permanently omitted or restricted if such publication would risk jeopardising the performance of Eurojust\u2019s tasks, taking into account its obligations of discretion and confidentiality and the operational character of Eurojust. Article 75 OLAF and the Court of Auditors 1. In order to facilitate the combating of fraud, corruption and other unlawful activities under Regulation (EU, Euratom) No 883/2013, within six months from the entry into force of this Regulation, Eurojust shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-fraud Office (OLAF) (26). Eurojust shall adopt appropriate provisions that apply to all national members, their deputies and Assistants, all seconded national experts and all Eurojust staff, using the template set out in the Annex to that Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds from Eurojust. 3. OLAF may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96 (27), with a view to establishing whether there have been any irregularities affecting the financial interests of the Union in connection with expenditure funded by Eurojust. 4. Without prejudice to paragraphs 1, 2 and 3, working arrangements with third countries or international organisations, the contracts, grant agreements and grant decisions of Eurojust shall contain provisions expressly empowering the Court of Auditors and OLAF to conduct such audits and investigations, according to their respective competences. 5. The staff of Eurojust, the Administrative Director and the members of the College and Executive Board shall, without delay and without their responsibility being called into question as a result, notify OLAF and the EPPO of any suspicion of irregular or illegal activity within their respective mandate, which has come to their attention in the fulfilment of their duties. Article 76 Rules on the protection of sensitive non-classified information and classified information 1. Eurojust shall establish internal rules on the handling and confidentiality of information and on the protection of sensitive non-classified information, including the creation and processing of such information at Eurojust. 2. Eurojust shall establish internal rules on the protection of EU classified information which shall be consistent with Council Decision 2013/488/EU (28) in order to ensure an equivalent level of protection for such information. Article 77 Administrative inquiries The administrative activities of Eurojust shall be subject to the inquiries of the European Ombudsman in accordance with Article 228 TFEU. Article 78 Liability other than liability for unauthorised or incorrect processing of data 1. Eurojust\u2019s contractual liability shall be governed by the law applicable to the contract in question. 2. The Court shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by Eurojust. 3. In the case of non-contractual liability, Eurojust shall, in accordance with the general principles common to the laws of the Member States and independently of any liability under Article 46, make good any damage caused by Eurojust or its staff in the performance of their duties. 4. Paragraph 3 shall also apply to damage caused through the fault of a national member, a deputy or an Assistant in the performance of their duties. However, when he or she is acting on the basis of the powers granted to him or her pursuant to Article 8, his or her Member State shall reimburse Eurojust the sums which Eurojust has paid to make good such damage. 5. The Court shall have jurisdiction in disputes over compensation for damages referred to in paragraph 3. 6. The national courts of the Member States competent to deal with disputes involving Eurojust\u2019s liability as referred to in this Article shall be determined by reference to Regulation (EU) No 1215/2012 of the European Parliament and of the Council (29). 7. The personal liability of Eurojust\u2019s staff towards Eurojust shall be governed by the applicable provisions laid down in the Staff Regulations of Officials and Conditions of Employment of Other Servants. Article 79 Headquarters agreement and operating conditions 1. The seat of Eurojust shall be The Hague, the Netherlands. 2. The necessary arrangements concerning the accommodation to be provided for Eurojust in the Netherlands and the facilities to be made available by the Netherlands together with the specific rules applicable in the Netherlands to the Administrative Director, members of the College, Eurojust staff and members of their families shall be laid down in a headquarters agreement between Eurojust and the Netherlands concluded once the College\u2019s approval is obtained. Article 80 Transitional arrangements 1. Eurojust as established by this Regulation shall be the general legal successor in respect of all contracts concluded by, liabilities incumbent upon, and properties acquired by Eurojust as established by Decision 2002/187/JHA. 2. The national members of Eurojust as established by Decision 2002/187/JHA who have been seconded by each Member State under that Decision shall take the role of national members of Eurojust under Section II of Chapter II of this Regulation. Their terms of office may be extended once under Article 7(5) of this Regulation after the entry into force of this Regulation, irrespective of a previous extension. 3. The President and Vice-Presidents of Eurojust as established by Decision 2002/187/JHA at the time of the entry into force of this Regulation shall take the role of the President and Vice-Presidents of Eurojust under Article 11 of this Regulation, until the expiry of their terms of office in accordance with that Decision. They may be re-elected once after the entry into force of this Regulation under Article 11(4) of this Regulation, irrespective of a previous re-election. 4. The Administrative Director who was last appointed under Article 29 of Decision 2002/187/JHA shall take the role of the Administrative Director under Article 17 of this Regulation until the expiry of his or her term of office as decided under that Decision. The term of office of that Administrative Director may be extended once after the entry into force of this Regulation. 5. This Regulation shall not affect the validity of agreements concluded by Eurojust as established by Decision 2002/187/JHA. In particular, all international agreements concluded by Eurojust before 12 December 2019 shall remain valid. 6. The discharge procedure in respect of the budgets approved on the basis of Article 35 of Decision 2002/187/JHA shall be carried out in accordance with the rules established by Article 36 thereof. 7. This Regulation shall not affect employment contracts which have been concluded under Decision 2002/187/JHA prior to the entry into force of this Regulation. The Data Protection Officer who was last appointed under Article 17 of that Decision shall take the role of the Data Protection Officer under Article 36 of this Regulation. Article 81 Replacement and repeal 1. Decision 2002/187/JHA is hereby replaced for the Member States bound by this Regulation with effect from 12 December 2019. Therefore, Decision 2002/187/JHA is repealed with effect from 12 December 2019. 2. With regard to the Member States bound by this Regulation, references to the Decision referred to in paragraph 1 shall be construed as references to this Regulation. Article 82 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 12 December 2019. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 14 November 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) Position of the European Parliament of 4 October 2018 (not yet published in the Official Journal) and decision of the Council of 6 November 2018. (2) Council Decision 2002/187/JHA of 28 February 2002 setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 63, 6.3.2002, p. 1). (3) Council Decision 2003/659/JHA of 18 June 2003 amending Decision 2002/187/JHA setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 245, 29.9.2003, p. 44). (4) Council Decision 2009/426/JHA of 16 December 2008 on the strengthening of Eurojust and amending Decision 2002/187/JHA setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 138, 4.6.2009, p. 14). (5) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (6) Council Decision 2002/494/JHA of 13 June 2002 setting up a European network of contact points in respect of persons responsible for genocide, crimes against humanity and war crimes (OJ L 167, 26.6.2002, p. 1). (7) Council Decision 2007/845/JHA of 6 December 2007 concerning cooperation between Asset Recovery Offices of the Member States in the field of tracing and identification of proceeds from, or other property related to, crime (OJ L 332, 18.12.2007, p. 103). (8) Council Decision 2008/852/JHA of 24 October 2008 on a contact-point network against corruption (OJ L 301, 12.11.2008, p. 38). (9) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (10) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002 (see page 39 of this Official Journal). (11) Council Common Position 2005/69/JHA of 24 January 2005 on exchanging certain data with Interpol (OJ L 27, 29.1.2005, p. 61). (12) Council Decision 2007/533/JHA of 12 June 2007 on the establishment, operation and use of the second generation Schengen Information System (SIS II) (OJ L 205, 7.8.2007, p. 63). (13) Council Joint Action 96/277/JHA of 22 April 1996 concerning a framework for the exchange of liaison magistrates to improve judicial cooperation between the Member States of the European Union (OJ L 105, 27.4.1996, p. 1). (14) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (15) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (16) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (17) Directive 2014/41/EU of the European Parliament and of the Council of 3 April 2014 regarding the European Investigation Order in criminal matters (OJ L 130, 1.5.2014, p. 1). (18) OJ L 56, 4.3.1968, p. 1. (19) Council Decision 2005/671/JHA of 20 September 2005 on the exchange of information and cooperation concerning terrorist offences (OJ L 253, 29.9.2005, p. 22). (20) Council Decision 2008/976/JHA of 16 December 2008 on the European Judicial Network (OJ L 348, 24.12.2008, p. 130). (21) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1). (22) Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (OJ L 328, 7.12.2013, p. 42). (23) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). (24) Council Regulation (EC) No 2965/94 of 28 November 1994 setting up a Translation Centre for bodies of the European Union (OJ L 314, 7.12.1994, p. 1). (25) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (26) OJ L 136, 31.5.1999, p. 15. (27) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (28) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). (29) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). ANNEX I List of forms of serious crime with which Eurojust is competent to deal in accordance with Article 3(1): \u2014 terrorism, \u2014 organised crime, \u2014 drug trafficking, \u2014 money-laundering activities, \u2014 crime connected with nuclear and radioactive substances, \u2014 immigrant smuggling, \u2014 trafficking in human beings, \u2014 motor vehicle crime, \u2014 murder and grievous bodily injury, \u2014 illicit trade in human organs and tissue, \u2014 kidnapping, illegal restraint and hostage taking, \u2014 racism and xenophobia, \u2014 robbery and aggravated theft, \u2014 illicit trafficking in cultural goods, including antiquities and works of art, \u2014 swindling and fraud, \u2014 crime against the financial interests of the Union, \u2014 insider dealing and financial market manipulation, \u2014 racketeering and extortion, \u2014 counterfeiting and product piracy, \u2014 forgery of administrative documents and trafficking therein, \u2014 forgery of money and means of payment, \u2014 computer crime, \u2014 corruption, \u2014 illicit trafficking in arms, ammunition and explosives, \u2014 illicit trafficking in endangered animal species, \u2014 illicit trafficking in endangered plant species and varieties, \u2014 environmental crime, including ship source pollution, \u2014 illicit trafficking in hormonal substances and other growth promoters, \u2014 sexual abuse and sexual exploitation, including child abuse material and solicitation of children for sexual purposes, \u2014 genocide, crimes against humanity and war crimes. ANNEX II CATEGORIES OF PERSONAL DATA REFERRED TO IN ARTICLE 27 1. (a) surname, maiden name, given names and any alias or assumed names; (b) date and place of birth; (c) nationality; (d) sex; (e) place of residence, profession and whereabouts of the person concerned; (f) social security number or other official numbers used in the Member State to identify individuals, driving licences, identification documents and passport data, customs and Tax Identification Numbers; (g) information concerning legal persons if it includes information relating to identified or identifiable individuals who are the subject of a judicial investigation or prosecution; (h) details of accounts held with banks or other financial institutions; (i) description and nature of the alleged offences, the date on which they were committed, the criminal category of the offences and the progress of the investigations; (j) the facts pointing to an international extension of the case; (k) details relating to alleged membership of a criminal organisation; (l) telephone numbers, email addresses, traffic data and location data, as well as any related data necessary to identify the subscriber or user; (m) vehicle registration data; (n) DNA profiles established from the non-coding part of DNA, photographs and fingerprints. 2. (a) surname, maiden name, given names and any alias or assumed names; (b) date and place of birth; (c) nationality; (d) sex; (e) place of residence, profession and whereabouts of the person concerned; (f) the description and nature of the offences involving the person concerned, the date on which the offences were committed, the criminal category of the offences and the progress of the investigations; (g) social security number or other official numbers used by the Member States to identify individuals, driving licences, identification documents and passport data, customs and Tax Identification Numbers; (h) details of accounts held with banks and other financial institutions; (i) telephone numbers, email addresses, traffic data and location data, as well as any related data necessary to identify the subscriber or user; (j) vehicle registration data.", "summary": "Eurojust (reform) Eurojust (reform) SUMMARY OF: Regulation (EU) 2018/1727 \u2014 the European Union Agency for Criminal Justice Cooperation (Eurojust) \u2014 replacing and repealing Council Decision 2002/187/JHA WHAT IS THE AIM OF THE REGULATION? It aims to tackle serious cross-border crime more efficiently by changing the structure of Eurojust and enabling the College of Eurojust to concentrate more on operational matters. It also takes into account the establishment of the European Public Prosecutor\u2019s Office (EPPO) and new rules for data protection in the European institutions and agencies. It also makes determining arrangements for involving the European Parliament and national parliaments in the evaluation of Eurojust\u2019s activities. It replaces and repeals Council Decision 2002/187/JHA. KEY POINTS Role of Eurojust Based on operations conducted and information supplied by the EU countries\u2019 authorities and by Europol, the EPPO and OLAF, supporting and strengthening coordination and cooperation between national investigating and prosecuting authorities in relation to serious crime which Eurojust is competent to deal with (see below), where that crime: affects 2 or more EU countries; orrequires prosecution on common bases. Carrying out its tasks at the request of the competent authorities of the EU countries, on its own initiative or at the request of the EPPO within the limits of the EPPO\u2019s competence. Eurojust\u2019s operational tasks include: cooperating closely with the EPPO on issues of competence; cooperating and consulting with the European Judicial Network in criminal matters; cooperating with EU institutions, bodies, offices and agencies, as well as networks established in the area of freedom, security and justice; supporting EU countries\u2019 action in combating forms of serious crime for which it is competent (e.g. terrorism; money laundering activities; trafficking in human beings; organ trafficking; drug and firearms trafficking); providing operational, technical and financial support to EU countries\u2019 cross-border operations and investigations, including to joint investigation teams. Competence Annex 1 of the Regulation sets out the forms of serious crime which Eurojust is competent to deal with in accordance with Article 3(1) of the Regulation. When the EPPO assumes its investigative and prosecutorial tasks, Eurojust will not exercise its competence for crimes for which the EPPO exercises its competence, except: in cases involving EU countries not participating in enhanced cooperation on the establishment of the EPPO; andat the request of those EU countries or at the request of the EPPO. Eurojust will exercise its competence for crimes affecting the financial interests of the EU in cases involving EU countries which participate in enhanced cooperation on the establishment of the EPPO, but for which the EPPO is not competent or decides not to exercise its competence. Eurojust will establish and maintain a close relationship with the EPPO based on mutual cooperation within their respective mandates. Structure and organisation Eurojust comprises: the national members;the College \u2014 consisting of all national members, plus 1 representative of the European Commission when the College is only carrying out its management functions, and not its operational functions;the Executive Board;the Administrative Director. The terms of office of the national members and their deputies is 5 years, renewable once. The Commission is represented on both the College and Executive Board. The Executive Board is responsible for taking administrative decisions to ensure the proper functioning of Eurojust. Processing of personal data The updated rules take into account the new data protection rules for EU institutions and agencies. EU countries are responsible for the accuracy of the data they transfer to Eurojust, for keeping those data up to date and for the legality of transmitting those data to Eurojust. Eurojust is responsible for the accuracy of data provided by other data suppliers or resulting from its own analyses or data collection and for keeping those data up to date. Eurojust should ensure that data are processed fairly and lawfully, and are collected and processed for a specific purpose. A data subject must have the right of access to operational personal data about him or her which are processed by Eurojust. Democratic control To increase the transparency and democratic oversight of Eurojust, its activities will be jointly evaluated by the European Parliament and national parliaments. FROM WHEN DOES THE REGULATION APPLY? It applies from 12 December 2019. BACKGROUND For further information, see: About Eurojust (Eurojust). MAIN DOCUMENT Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, pp. 138-183) RELATED DOCUMENTS Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, pp. 39-98) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, pp. 1-71) Council Decision 2009/426/JHA of 16 December 2008 on the strengthening of Eurojust and amending Decision 2002/187/JHA setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 138, 4.6.2009, pp. 14-32) Council Decision 2002/187/JHA of 28 February 2002 setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 63, 6.3.2002, pp. 1-13) Successive amendments to Decision 2002/187/JHA have been incorporated in the basic text. This consolidated version is of documentary value only. last update 21.03.2019"}
{"article": "12.11.2018 EN Official Journal of the European Union L 284/22 DIRECTIVE (EU) 2018/1673 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 October 2018 on combating money laundering by criminal law THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 83(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Money laundering and the related financing of terrorism and organised crime remain significant problems at Union level, thus damaging the integrity, stability and reputation of the financial sector and threatening the internal market and the internal security of the Union. In order to tackle those problems and to complement and reinforce the application of Directive (EU) 2015/849 of the European Parliament and of the Council (2), this Directive aims to combat money laundering by means of criminal law, enabling more efficient and swifter cross-border cooperation between competent authorities. (2) Measures adopted solely at national or even at Union level, without taking into account international coordination and cooperation, would have very limited effect. The measures adopted by the Union to combat money laundering should therefore be compatible with, and at least as stringent as, other actions undertaken in international fora. (3) Union action should continue to take particular account of the Financial Action Task Force (FATF) Recommendations and instruments of other international organisations and bodies active in the fight against money laundering and terrorist financing. The relevant Union legal acts should, where appropriate, be further aligned with the International Standards on Combating Money Laundering and the Financing of Terrorism and Proliferation adopted by the FATF in February 2012 (the \u2018revised FATF Recommendations\u2019). As a signatory to the Council of Europe Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and on the Financing of Terrorism, the Union should transpose the requirements of that Convention into its legal order. (4) Council Framework Decision 2001/500/JHA (3) lays down requirements with regard to the criminalisation of money laundering. However, that Framework Decision is not comprehensive enough and the current criminalisation of money laundering is not sufficiently coherent to effectively combat money laundering across the Union and results in enforcement gaps and in obstacles to cooperation between the competent authorities in different Member States. (5) The definition of criminal activities which constitute predicate offences for money laundering should be sufficiently uniform in all Member States. Member States should ensure that all offences that are punishable by a term of imprisonment as set out in this Directive are considered predicate offences for money laundering. Moreover, to the extent that the application of those penalty thresholds does not already do so, Member States should include a range of offences within each of the categories of offences listed in this Directive. In that case, Member States should be able to decide how to delimit the range of offences within each category. Where a category of offences, such as terrorism or environmental offences, includes offences set out in legal acts of the Union, this Directive should refer to those legal acts. Member States should, however, consider any offence set out in those legal acts as constituting a predicate offence for money laundering. Any kind of punishable involvement in the commission of a predicate offence as criminalised in accordance with national law should also be considered as a criminal activity for the purposes of this Directive. In cases where Union law allows Member States to provide for sanctions other than criminal sanctions, this Directive should not require Member States to classify the offences in those cases as predicate offences for the purposes of this Directive. (6) The use of virtual currencies presents new risks and challenges from the perspective of combating money laundering. Member States should ensure that those risks are addressed appropriately. (7) Due to the impact of money laundering offences committed by public office holders on the public sphere and on the integrity of public institutions, Member States should be able to consider including more severe penalties for public office holders in their national frameworks in accordance with their legal traditions. (8) Tax crimes relating to direct and indirect taxes should be covered by the definition of criminal activity, in line with the revised FATF Recommendations. Given that different tax crimes in each Member State can constitute a criminal activity punishable by the sanctions referred to in this Directive, the definitions of tax crimes might diverge in national law. The aim of this Directive, however, is not to harmonise the definitions of tax crimes in national law. (9) In criminal proceedings regarding money laundering, Member States should assist each other in the widest possible way and ensure that information is exchanged in an effective and timely manner in accordance with national law and the existing Union legal framework. Differences between the definitions of predicate offences in national law should not hinder international cooperation in criminal proceedings regarding money laundering. Cooperation with third countries should be intensified, in particular by encouraging and supporting the establishment of effective measures and mechanisms to combat money laundering and by ensuring better international cooperation in this field. (10) This Directive does not apply to money laundering involving property derived from criminal offences affecting the Union\u2019s financial interests, which is subject to specific rules as laid down in Directive (EU) 2017/1371 of the European Parliament and of the Council (4). This is without prejudice to the possibility for Member States to transpose this Directive and Directive (EU) 2017/1371 by means of a single comprehensive framework at national level. In accordance with Article 325(2) of the Treaty on the Functioning of the European Union (TFEU), the Member States are to take the same measures to counter fraud affecting the financial interests of the Union as they take to counter fraud affecting their own financial interests. (11) Member States should ensure that certain types of money laundering activities are also punishable when committed by the perpetrator of the criminal activity that generated the property (\u2018self-laundering\u2019). In such cases, where, the money laundering activity does not simply amount to the mere possession or use of property, but also involves the transfer, conversion, concealment or disguise of property and results in further damage than that already caused by the criminal activity, for instance by putting the property derived from criminal activity into circulation and, by doing so, concealing its unlawful origin, that money laundering activity should be punishable. (12) In order for criminal law measures to be effective against money laundering, a conviction should be possible without it being necessary to establish precisely which criminal activity generated the property, or for there to be a prior or simultaneous conviction for that criminal activity, while taking into account all relevant circumstances and evidence. It should be possible for Member States, in line with their national legal systems, to ensure this by means other than legislation. Prosecutions for money laundering should also not be impeded by the fact that the criminal activity was committed in another Member State or in a third country, subject to the conditions set out in this Directive. (13) This Directive aims to criminalise money laundering when it is committed intentionally and with the knowledge that the property was derived from criminal activity. In that context, this Directive should not distinguish between situations where property has been derived directly from criminal activity and situations where it has been derived indirectly from criminal activity, in line with the broad definition of \u2018proceeds\u2019 as laid down in Directive 2014/42/EU of the European Parliament and of the Council (5). In each case, when considering whether the property is derived from criminal activity and whether the person knew that, the specific circumstances of the case should be taken into account, such as the fact that the value of the property is disproportionate to the lawful income of the accused person and that the criminal activity and acquisition of property occurred within the same time frame. Intention and knowledge can be inferred from objective, factual circumstances. As this Directive provides for minimum rules concerning the definition of criminal offences and sanctions in the area of money laundering, Member States are free to adopt or maintain more stringent criminal law rules in that area. Member States should be able, for example, to provide that money laundering committed recklessly or by serious negligence constitutes a criminal offence. References in this Directive to money laundering committed by negligence should be understood as such for Member States that criminalise such conduct. (14) In order to deter money laundering throughout the Union, Member States should ensure that it is punishable by a maximum term of imprisonment of at least four years. That obligation is without prejudice to the individualisation and application of penalties and the execution of sentences in accordance with the concrete circumstances in each individual case. Member States should also provide for additional sanctions or measures, such as fines, temporary or permanent exclusion from access to public funding, including tender procedures, grants and concessions, temporary disqualifications from the practice of commercial activities or temporary bans on running for elected or public office. That obligation is without prejudice to the discretion of the judge or the court to decide whether to impose additional sanctions or measures or not, taking into account all the circumstances of the particular case. (15) While there is no obligation to increase sentences, Member States should ensure that the judge or the court is able to take the aggravating circumstances set out in this Directive into account when sentencing offenders. It remains within the discretion of the judge or the court to determine whether to increase the sentence due to the specific aggravating circumstances, taking into account all the facts of the particular case. Member States should not be obliged to provide for aggravating circumstances where national law provides for the criminal offences laid down in Council Framework Decision 2008/841/JHA (6) or for offences committed by natural persons acting as obliged entities in the exercise of their professional activities to be punishable as separate criminal offences and this may lead to more severe sanctions. (16) The freezing and confiscation of the instrumentalities and proceeds of crime remove the financial incentives which drive crime. Directive 2014/42/EU lays down minimum rules on the freezing and confiscation of the instrumentalities and proceeds of crime in criminal matters. That Directive also requires the Commission to report to the European Parliament and to the Council on its implementation and make adequate proposals if necessary. Member States should, as a minimum, ensure the freezing and confiscation of the instrumentalities and proceeds of crime in all cases provided for in Directive 2014/42/EU. Member States should also strongly consider enabling confiscation in all cases where it is not possible to initiate or conclude criminal proceedings, including in cases where the offender has died. As requested by the European Parliament and the Council in the statement accompanying Directive 2014/42/EU, the Commission will submit a report analysing the feasibility and possible benefits of introducing further common rules on the confiscation of property deriving from activities of a criminal nature, including in the absence of a conviction of a specific person or persons for those activities. Such analysis will take into account the differences between the legal traditions and systems of the Member States. (17) Given the mobility of perpetrators and proceeds stemming from criminal activities, as well as the complex cross-border investigations required to combat money laundering, all Member States should establish their jurisdiction in order to enable the competent authorities to investigate and prosecute such activities. Member States should thereby ensure that their jurisdiction includes situations where an offence is committed by means of information and communication technology from their territory, whether such technology is based on their territory or not. (18) Under Council Framework Decision 2009/948/JHA (7) and Council Decision 2002/187/JHA (8), the competent authorities of two or more Member States conducting parallel criminal proceedings in respect of the same facts involving the same person are, with the assistance of Eurojust, to enter into direct consultations with one another, in particular to ensure that all offences covered by this Directive are prosecuted. (19) To ensure the successful investigation and prosecution of money laundering offences, those responsible for investigating or prosecuting such offences should have the possibility to make use of effective investigative tools such as those which are used in combating organised crime or other serious crimes. It should thereby be ensured that sufficient personnel and targeted training, resources and up-to-date technological capacity are available. The use of such tools, in accordance with national law, should be targeted and take into account the principle of proportionality and the nature and seriousness of the offences under investigation and should respect the right to the protection of personal data. (20) This Directive replaces certain provisions of Framework Decision 2001/500/JHA for the Member States bound by this Directive. (21) This Directive respects the principles recognised by Article 2 of the Treaty on European Union (TEU), respects fundamental rights and freedoms and observes the principles recognised, in particular, by the Charter of Fundamental Rights of the European Union, including those set out in Titles II, III, V and VI thereof which encompass, inter alia, the right to respect for private and family life and the right to protection of personal data, the principles of legality and proportionality of criminal offences and penalties, covering also the requirement of precision, clarity and foreseeability in criminal law, the presumption of innocence, as well as the rights of suspects and accused persons to have access to a lawyer, the right not to incriminate oneself and the right to a fair trial. This Directive has to be implemented in accordance with those rights and principles, taking also into account the European Convention for the Protection of Human Rights and Fundamental Freedoms, the International Covenant on Civil and Political Rights, and other human rights obligations under international law. (22) Since the objective of this Directive, namely to subject money laundering in all Member States to effective, proportionate and dissuasive criminal penalties, cannot be sufficiently achieved by Member States but can rather, by reason of the scale and effects of this Directive, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the TEU. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective. (23) In accordance with Articles 1 and 2 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, the United Kingdom and Ireland are not taking part in the adoption of this Directive and are not bound by it or subject to its application. (24) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application. Framework Decision 2001/500/JHA continues to be binding upon and applicable to Denmark, HAVE ADOPTED THIS DIRECTIVE: Article 1 Subject matter and scope 1. This Directive establishes minimum rules concerning the definition of criminal offences and sanctions in the area of money laundering. 2. This Directive does not apply to money laundering as regards property derived from criminal offences affecting the Union\u2019s financial interests, which is subject to specific rules laid down in Directive (EU) 2017/1371. Article 2 Definitions For the purposes of this Directive, the following definitions apply: (1) \u2018criminal activity\u2019 means any kind of criminal involvement in the commission of any offence punishable, in accordance with national law, by deprivation of liberty or a detention order for a maximum of more than one year or, as regards Member States that have a minimum threshold for offences in their legal systems, any offence punishable by deprivation of liberty or a detention order for a minimum of more than six months. In any case, offences within the following categories are considered a criminal activity: (a) participation in an organised criminal group and racketeering, including any offence set out in Framework Decision 2008/841/JHA; (b) terrorism, including any offence set out in Directive (EU) 2017/541 of the European Parliament and of the Council (9); (c) trafficking in human beings and migrant smuggling, including any offence set out in Directive 2011/36/EU of the European Parliament and of the Council (10) and Council Framework Decision 2002/946/JHA (11); (d) sexual exploitation, including any offence set out in Directive 2011/93/EU of the European Parliament and of the Council (12); (e) illicit trafficking in narcotic drugs and psychotropic substances, including any offence set out in Council Framework Decision 2004/757/JHA (13); (f) illicit arms trafficking; (g) illicit trafficking in stolen goods and other goods; (h) corruption, including any offence set out in the Convention on the fight against corruption involving officials of the European Communities or officials of Member States of the European Union (14) and in Council Framework Decision 2003/568/JHA (15); (i) fraud, including any offence set out in Council Framework Decision 2001/413/JHA (16); (j) counterfeiting of currency, including any offence set out in Directive 2014/62/EU of the European Parliament and of the Council (17); (k) counterfeiting and piracy of products; (l) environmental crime, including any offence set out in Directive 2008/99/EC of the European Parliament and of the Council (18) or in Directive 2009/123/EC of the European Parliament and of the Council (19); (m) murder, grievous bodily injury; (n) kidnapping, illegal restraint and hostage-taking; (o) robbery or theft; (p) smuggling; (q) tax crimes relating to direct and indirect taxes, as laid down in national law; (r) extortion; (s) forgery; (t) piracy; (u) insider trading and market manipulation, including any offence set out in Directive 2014/57/EU of the European Parliament and of the Council (20); (v) cybercrime, including any offence set out in Directive 2013/40/EU of the European Parliament and of the Council (21). (2) \u2018property\u2019 means assets of any kind, whether corporeal or incorporeal, movable or immovable, tangible or intangible, and legal documents or instruments in any form, including electronic or digital, evidencing title to, or an interest in, such assets; (3) \u2018legal person\u2019 means any entity having legal personality under the applicable law, except for states or public bodies in the exercise of state authority and for public international organisations. Article 3 Money laundering offences 1. Member States shall take the necessary measures to ensure that the following conduct, when committed intentionally, is punishable as a criminal offence: (a) the conversion or transfer of property, knowing that such property is derived from criminal activity, for the purpose of concealing or disguising the illicit origin of the property or of assisting any person who is involved in the commission of such an activity to evade the legal consequences of that person\u2019s action; (b) the concealment or disguise of the true nature, source, location, disposition, movement, rights with respect to, or ownership of, property, knowing that such property is derived from criminal activity; (c) the acquisition, possession or use of property, knowing at the time of receipt, that such property was derived from criminal activity. 2. Member States may take the necessary measures to ensure that the conduct referred to in paragraph 1 is punishable as a criminal offence where the offender suspected or ought to have known that the property was derived from criminal activity. 3. Member States shall take the necessary measures to ensure that: (a) a prior or simultaneous conviction for the criminal activity from which the property was derived is not a prerequisite for a conviction for the offences referred to in paragraphs 1 and 2; (b) a conviction for the offences referred to in paragraphs 1 and 2 is possible where it is established that the property was derived from a criminal activity, without it being necessary to establish all the factual elements or all circumstances relating to that criminal activity, including the identity of the perpetrator; (c) the offences referred to in paragraphs 1 and 2 extend to property derived from conduct that occurred on the territory of another Member State or of a third country, where that conduct would constitute a criminal activity had it occurred domestically. 4. In the case of point (c) of paragraph 3 of this Article, Member States may further require that the relevant conduct constitutes a criminal offence under the national law of the other Member State or of the third country where that conduct was committed, except where that conduct constitutes one of the offences referred to in points (a) to (e) and (h) of point (1) of Article 2 and as defined in the applicable Union law. 5. Member States shall take the necessary measures to ensure that the conduct referred to in points (a) and (b) of paragraph 1 is punishable as a criminal offence when committed by persons who committed, or were involved in, the criminal activity from which the property was derived. Article 4 Aiding and abetting, inciting and attempting Member States shall take the necessary measures to ensure that aiding and abetting, inciting and attempting an offence referred to in Article 3(1) and (5) is punishable as a criminal offence. Article 5 Penalties for natural persons 1. Member States shall take the necessary measures to ensure that the offences referred to in Articles 3 and 4 are punishable by effective, proportionate and dissuasive criminal penalties. 2. Member States shall take the necessary measures to ensure that the offences referred to in Article 3(1) and (5) are punishable by a maximum term of imprisonment of at least four years. 3. Member States shall also take the necessary measures to ensure that natural persons who have committed the offences referred to in Articles 3 and 4 are, where necessary, subject to additional sanctions or measures. Article 6 Aggravating circumstances 1. Member States shall take the necessary measures to ensure that, in relation to the offences referred to in Article 3(1) and (5) and Article 4, the following circumstances are to be regarded as aggravating circumstances: (a) the offence was committed within the framework of a criminal organisation within the meaning of Framework Decision 2008/841/JHA; or (b) the offender is an obliged entity within the meaning of Article 2 of Directive (EU) 2015/849 and has committed the offence in the exercise of their professional activities. 2. Member States may provide that, in relation to the offences referred to in Article 3(1) and (5) and Article 4, the following circumstances are to be regarded as aggravating circumstances: (a) the laundered property is of considerable value; or (b) the laundered property derives from one of the offences referred to in points (a) to (e) and (h) of point (1) of Article 2. Article 7 Liability of legal persons 1. Member States shall take the necessary measures to ensure that legal persons can be held liable for any of the offences referred to in Article 3(1) and (5) and Article 4 committed for their benefit by any person, acting either individually or as part of an organ of the legal person and having a leading position within the legal person, based on any of the following: (a) a power of representation of the legal person; (b) an authority to take decisions on behalf of the legal person; or (c) an authority to exercise control within the legal person. 2. Member States shall take the necessary measures to ensure that legal persons can be held liable where the lack of supervision or control by a person referred to in paragraph 1 of this Article has made possible the commission of any of the offences referred to in Article 3(1) and (5) and Article 4 for the benefit of that legal person by a person under its authority. 3. Liability of legal persons under paragraphs 1 and 2 of this Article shall not preclude criminal proceedings from being brought against natural persons who are perpetrators, inciters or accessories in any of the offences referred to in Article 3(1) and (5) and Article 4. Article 8 Sanctions for legal persons Member States shall take the necessary measures to ensure that a legal person held liable pursuant to Article 7 is punishable by effective, proportionate and dissuasive sanctions, which shall include criminal or non-criminal fines and may include other sanctions, such as: (a) exclusion from entitlement to public benefits or aid; (b) temporary or permanent exclusion from access to public funding, including tender procedures, grants and concessions; (c) temporary or permanent disqualification from the practice of commercial activities; (d) placing under judicial supervision; (e) a judicial winding-up order; (f) temporary or permanent closure of establishments which have been used for committing the offence. Article 9 Confiscation Member States shall take the necessary measures to ensure, as appropriate, that their competent authorities freeze or confiscate, in accordance with Directive 2014/42/EU, the proceeds derived from and instrumentalities used or intended to be used in the commission or contribution to the commission of the offences as referred to in this Directive. Article 10 Jurisdiction 1. Each Member State shall take the necessary measures to establish its jurisdiction over the offences referred to in Articles 3 and 4 where: (a) the offence is committed in whole or in part on its territory; (b) the offender is one of its nationals. 2. A Member State shall inform the Commission where it decides to extend its jurisdiction to offences referred to in Articles 3 and 4 which have been committed outside its territory where: (a) the offender is a habitual resident on its territory; (b) the offence is committed for the benefit of a legal person established on its territory. 3. Where an offence referred to in Articles 3 and 4 falls within the jurisdiction of more than one Member State and where any of the Member States concerned can validly prosecute on the basis of the same facts, the Member States concerned shall cooperate in order to decide which of them will prosecute the offender, with the aim of centralising proceedings in a single Member State. Account shall be taken of the following factors: (a) the territory of the Member State on which the offence was committed; (b) the nationality or residency of the offender; (c) the country of origin of the victim or victims; and (d) the territory on which the offender was found. The matter shall, where appropriate and in accordance with Article 12 of Framework Decision 2009/948/JHA, be referred to Eurojust. Article 11 Investigative tools Member States shall take the necessary measures to ensure that effective investigative tools, such as those used in combating organised crime or other serious crimes are available to the persons, units or services responsible for investigating or prosecuting the offences referred to in Article 3(1) and (5) and Article 4. Article 12 Replacement of certain provisions of Framework Decision 2001/500/JHA Point (b) of Article 1 and Article 2 of Framework Decision 2001/500/JHA are replaced with regard to the Member States bound by this Directive, without prejudice to the obligations of those Member States with regard to the date for transposition of that Framework Decision into national law. With regard to the Member States bound by this Directive, references to the provisions of Framework Decision 2001/500/JHA referred to in the first paragraph shall be construed as references to this Directive. Article 13 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 3 December 2020. They shall immediately inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 14 Reporting The Commission shall, by 3 December 2022, submit a report to the European Parliament and to the Council, assessing the extent to which the Member States have taken the necessary measures to comply with this Directive. The Commission shall, by 3 December 2023, submit a report to the European Parliament and to the Council assessing the added value of this Directive with regard to combating money laundering as well as its impact on fundamental rights and freedoms. On the basis of that report, the Commission shall, if necessary, present a legislative proposal to amend this Directive. The Commission shall take into account the information provided by Member States. Article 15 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 16 Addressees This Directive is addressed to the Member States in accordance with the Treaties. Done at Strasbourg, 23 October 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) Position of the European Parliament of 12 September 2018 (not yet published in the Official Journal) and decision of the Council of 11 October 2018. (2) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73). (3) Council Framework Decision 2001/500/JHA of 26 June 2001 on money laundering, the identification, tracing, freezing, seizing and confiscation of instrumentalities and the proceeds of crime (OJ L 182, 5.7.2001, p. 1). (4) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (5) Directive 2014/42/EU of the European Parliament and of the Council of 3 April 2014 on the freezing and confiscation of instrumentalities and proceeds of crime in the European Union (OJ L 127, 29.4.2014, p. 39). (6) Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (OJ L 300, 11.11.2008, p. 42). (7) Council Framework Decision 2009/948/JHA of 30 November 2009 on prevention and settlement of conflicts of exercise of jurisdiction in criminal proceedings (OJ L 328, 15.12.2009, p. 42). (8) Council Decision 2002/187/JHA of 28 February 2002 setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 63, 6.3.2002, p. 1). (9) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, p. 6). (10) Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, and replacing Council Framework Decision 2002/629/JHA (OJ L 101, 15.4.2011, p. 1). (11) Council Framework Decision 2002/946/JHA of 28 November 2002 on the strengthening of the penal framework to prevent the facilitation of unauthorised entry, transit and residence (OJ L 328, 5.12.2002, p. 1). (12) Directive 2011/93/EU of the European Parliament and of the Council of 13 December 2011 on combating the sexual abuse and sexual exploitation of children and child pornography, and replacing Council Framework Decision 2004/68/JHA (OJ L 335, 17.12.2011, p. 1). (13) Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8). (14) Council Act of 26 May 1997 drawing up, on the basis of Article K.3 (2) (c) of the Treaty on European Union, the Convention on the fight against corruption involving officials of the European Communities or officials of Member States of the European Union (OJ C 195, 25.6.1997, p. 1). (15) Council Framework Decision 2003/568/JHA of 22 July 2003 on combating corruption in the private sector (OJ L 192, 31.7.2003, p. 54). (16) Council Framework Decision 2001/413/JHA of 28 May 2001 combating fraud and counterfeiting of non-cash means of payment (OJ L 149, 2.6.2001, p. 1). (17) Directive 2014/62/EU of the European Parliament and of the Council of 15 May 2014 on the protection of the euro and other currencies against counterfeiting by criminal law, and replacing Council Framework Decision 2000/383/JHA (OJ L 151, 21.5.2014, p. 1). (18) Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28). (19) Directive 2009/123/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2005/35/EC on ship-source pollution and on the introduction of penalties for infringements (OJ L 280, 27.10.2009, p. 52). (20) Directive 2014/57/EU of the European Parliament and of the Council of 16 April 2014 on criminal sanctions for market abuse (market abuse directive) (OJ L 173, 12.6.2014, p. 179). (21) Directive 2013/40/EU of the European Parliament and of the Council of 12 August 2013 on attacks against information systems and replacing Council Framework Decision 2005/222/JHA (OJ L 218, 14.8.2013, p. 8).", "summary": "Combating money laundering by criminal law Combating money laundering by criminal law SUMMARY OF: Directive (EU) 2018/1673 on combating money laundering by criminal law WHAT IS THE AIM OF THIS DIRECTIVE? It defines criminal offences and sanctions in the area of money laundering with the aim of: facilitating police and judicial cooperation between European Union (EU) Member States; andpreventing criminals from taking advantage of more lenient legal systems. It aims to criminalise money laundering when it is committed intentionally and with the knowledge that the property* came from criminal activity. It also allows Member States to criminalise money laundering where the offender suspected or ought to have known that the property came from criminal activity. KEY POINTS Criminal offences The following, if committed intentionally, are a criminal offences: transferring or converting property (assets of any kind), knowing that it came from criminal activity, to hide or disguise its illicit origin or to assist anybody involved to evade the legal consequences of their actions;hiding or disguising the true nature, source, location, disposition, movement, rights with respect to, or ownership of, property, knowing that it came from criminal activity;acquiring, possessing or using property knowing, at the time it was received, that it had come from criminal activity;aiding and abetting, inciting and attempting these offences. Criminal activity (or \u2018predicate offence\u2019) For the purposes of this directive, the following conduct is considered to be a criminal activity, i.e. relevant for the crime of money laundering: any kind of criminal involvement in the commissioning of any offence punishable, in accordance with national law, by imprisonment or a detention order for a minimum of more than 6 months or a maximum of more than 1 year; andin so far as not already covered by the category above, offences within a list of 22 designated categories of crime, including all the offences defined in EU legislation designated by this directive. Additional factors The offences extend to property derived from activity in another EU Member State or a non-EU country, where it would be considered a criminal activity if it had occurred domestically. Member States must ensure that persons who committed, or were involved in, this criminal activity are subject to punishment. Additional factors include: criminal liability extends also to those who launder the proceeds of their own crimes (\u2018self-laundering\u2019);a previous or simultaneous conviction for the criminal activity from which the property came is not a prerequisite for a conviction for money laundering;it is possible to convict without needing to establish all the facts about the criminal activity, including the perpetrator\u2019s identity. Aggravating circumstances which make offences more serious These include instances where: the offence was committed within the framework of a criminal organisation as defined in Framework Decision 2008/841/JHA; orthe offender committed the offence when carrying out their professional activities as \u2018obliged entities\u2019, as defined in Article 2 of Directive (EU) 2015/849 (see summary). Member States may also choose to regard the following as aggravating circumstances: where the laundered property is of high value; orwhere the laundered property comes from racketeering, terrorism, human trafficking, narcotics trafficking or corruption. Penalties and sanctions Punishment must be effective, proportionate and dissuasive. Member States should impose a maximum term of imprisonment of at least 4 years and, where necessary, apply additional sanctions or measures, including measures holding legal entities liable, such as: exclusion from entitlement to public benefits or aid;exclusion from access to public funding, including tendering, grants and concessions;disqualification from carrying out commercial activities;judicial supervision;judicial winding-up orders;closing premises used for committing the offence;freezing or confiscating the property concerned. Package of legislation The directive is part of a package of legislation which includes Regulation (EU) 2018/1672 on controls on cash entering or leaving the EU, and complements and reinforces the application of Directive (EU) 2015/849 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing. Investigation tools and cooperation Member States must ensure that effective investigative tools, such as those used in combating organised crime or other serious crimes, are available to those responsible for investigating or prosecuting the offences. The directive also removes obstacles to judicial and police cooperation between Member States by clarifying which country has jurisdiction, and how countries cooperate, as well as how to involve Eurojust. Money laundering affecting the EU\u2019s financial interests Directive (EU) 2017/1371 sets out rules concerning criminal offences and penalties on combatting fraud and other illegal activities detrimental to the Union\u2019s financial interests (see summary). These activities include money laundering. Article 22(1) of Regulation (EU) 2017/1939 establishing the European Public Prosecutor\u2019s Office (EPPO) (see summary) gives the EPPO powers in respect of the criminal offences affecting the financial interests of the Union that are set out in Directive (EU) 2017/1371. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 2 December 2018 and had to become law in the Member States by 3 December 2020. BACKGROUND The directive is also associated with legislation on: the fight against fraud; combating terrorism; prevention of the use of the financial system for the purposes of money laundering or terrorist financing; protection against counterfeiting; freezing and confiscating the proceeds of crime. KEY TERMS Property. Assets of any kind, whether physical or virtual, movable or immovable, tangible or intangible, and legal documents in any form, including electronic or digital, which are evidence of ownership or interest in such assets. MAIN DOCUMENT Directive (EU) 2018/1673 of the European Parliament and of the Council of 23 October 2018 on combating money laundering by criminal law (OJ L 284, 12.11.2018, pp. 22\u201330). RELATED DOCUMENTS Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, pp. 138\u2013183). Regulation (EU) 2018/1672 of the European Parliament and of the Council of 23 October 2018 on controls on cash entering or leaving the Union and repealing Regulation (EC) No 1889/2005 (OJ L 284, 12.11.2018, pp. 6\u201321). Successive amendments to Regulation (EU) 2018/1672 have been incorporated in the original text. This consolidated version is of documentary value only. Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, pp. 1\u201371). See consolidated version. Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, pp. 29\u201341). Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, pp. 6\u201321). Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, pp. 73\u2013117). See consolidated version. Directive 2014/62/EU of the European Parliament and of the Council of 15 May 2014 on the protection of the euro and other currencies against counterfeiting by criminal law, and replacing Council Framework Decision 2000/383/JHA (OJ L 151, 21.5.2014, pp. 1\u20138). Directive 2014/42/EU of the European Parliament and of the Council of 3 April 2014 on the freezing and confiscation of instrumentalities and proceeds of crime in the European Union (OJ L 127, 29.4.2014, pp. 39\u201350). See consolidated version. Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (OJ L 300, 11.11.2008, pp. 42\u201345). last update 02.03.2022"}
{"article": "16.9.2016 EN Official Journal of the European Union L 252/1 REGULATION (EU) 2016/1627 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 September 2016 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, and repealing Council Regulation (EC) No 302/2009 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The objective of the common fisheries policy (CFP), as set out in Regulation (EU) No 1380/2013 of the European Parliament and of the Council (3), is to ensure an exploitation of living aquatic resources that provides sustainable economic, environmental and social conditions. (2) The Union is Party to the International Convention for the Conservation of Atlantic Tunas (4) (\u2018the Convention\u2019). (3) At its 15th special meeting in 2006, the International Commission for the Conservation of Atlantic Tunas (\u2018ICCAT\u2019), established by the Convention, adopted Recommendation 06-05 establishing a multiannual recovery plan for bluefin tuna in the eastern Atlantic and Mediterranean ending in 2022 (\u2018the recovery plan\u2019). That Recommendation entered into force on 13 June 2007. (4) The recovery plan takes into account the specificities of the different types of gear and fishing techniques. When implementing the recovery plan, the Union and Member States should endeavour to promote coastal fishing activities and the use of fishing gear and techniques which are selective and have a reduced environmental impact, including gear and techniques used in traditional and artisanal fisheries, thereby contributing to a fair standard of living for local economies. (5) ICCAT Recommendation 06-05 was implemented into Union law by Council Regulation (EC) No 1559/2007 (5). (6) At its 16th special meeting in 2008, ICCAT adopted Recommendation 08-05 amending Recommendation 06-05. In order to rebuild the stock of bluefin tuna, Recommendation 08-05 provided for a gradual reduction in the total allowable catch level from 2007 to 2011, restrictions on fishing within certain areas and time periods, a new minimum size for bluefin tuna, measures concerning sport and recreational fishing activities, farming and fishing capacity measures, as well as reinforcing the ICCAT Scheme of Joint International Inspection. (7) ICCAT Recommendation 08-05 was implemented into Union law by Council Regulation (EC) No 302/2009 (6). (8) At its 17th special meeting in 2010, ICCAT adopted Recommendation 10-04 amending Recommendation 08-05. In order to rebuild the stock of bluefin tuna, Recommendation 10-04 established a further reduction of the total allowable catch and the fishing capacity and it reinforced the control measures, in particular those concerning transfer and caging operations. It also provided for additional advice by the Standing Committee on Research and Statistics of ICCAT (\u2018SCRS\u2019) in 2012 on the identification of spawning grounds and on the creation of sanctuaries. (9) In order to implement the revised international conservation measures set out in Recommendation 10-04 into Union law, Regulation (EC) No 302/2009 was amended by Regulation (EU) No 500/2012 of the European Parliament and of the Council (7). (10) At its 18th special meeting in 2012, ICCAT adopted Recommendation 12-03 amending Recommendation 10-04. In order to strengthen the effectiveness of the recovery plan, Recommendation 12-03 set up technical measures concerning the transfer and caging operations of live bluefin tuna, new catch reporting requirements, the implementation of the ICCAT regional observer programme and changes of the fishing seasons. Furthermore, it reinforced the role of the SCRS with regard to the assessment of bluefin tuna stock. (11) At its 23rd regular meeting in 2013, ICCAT adopted Recommendation 13-07 amending Recommendation 12-03 by introducing small changes on fishing seasons which do not affect the Union fleet. Furthermore, Recommendation 13-08 was adopted which complements the recovery plan. Recommendation 13-08 set up a common procedure for the use of stereoscopical camera systems to estimate the quantities of bluefin tuna at the point of caging and introduced a flexible starting date for the fishing season of baitboats and trolling boats in the eastern Atlantic. (12) In order to implement essential measures, such as those on fishing seasons, of Recommendations 12-03 and 13-08 into Union law, Regulation (EC) No 302/2009 was further amended by Regulation (EU) No 544/2014 of the European Parliament and of the Council (8). (13) At its 19th special meeting in 2014, ICCAT adopted Recommendation 14-04 amending Recommendation 13-07 and repealing Recommendation 13-08. Whilst some of the existing control provisions were rationalised, the procedures for the use of stereoscopic camera at the point of caging were further specified and measures specific to release operations and the treatment of dead fish were introduced in the recovery plan. (14) Recommendation 14-04 is binding on the Union. (15) All the amendments to the recovery plan adopted by ICCAT in 2012, 2013 and 2014, which have not yet been subject to implementation, should be implemented into Union law. As that implementation concerns the recovery plan whose objectives and measures were defined by ICCAT, this Regulation does not cover all the content of multiannual plans as set out in Articles 9 and 10 of Regulation (EU) No 1380/2013. (16) Regulation (EU) No 1380/2013 establishes the concept of minimum conservation reference sizes. In order to ensure consistency, the ICCAT concept of minimum sizes should be transposed into Union law as minimum conservation reference sizes. Consequently, the references in Commission Delegated Regulation (EU) 2015/98 (9) to minimum sizes of bluefin tuna should be read as references to minimum conservation reference sizes in this Regulation. (17) In order to ensure uniform conditions for the implementation of the provisions of this Regulation relating to transfer operations, caging operations and recording and reporting of trap and vessel activities, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (10). (18) Certain provisions of Regulation (EC) No 302/2009 have become obsolete, in particular since they are now covered by other Union acts. Other provisions should be updated in order to reflect changes in legislation, in particular those resulting from the adoption of Regulation (EU) No 1380/2013. (19) In particular, Council Regulation (EC) No 1224/2009 (11) establishes a Union system for control, inspection and enforcement with a global and integrated approach so as to ensure compliance with all the rules of the CFP, and Commission Implementing Regulation (EU) No 404/2011 (12) lays down detailed rules for the implementation of Regulation (EC) No 1224/2009. Council Regulation (EC) No 1005/2008 (13) establishes a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing. Those acts now cover some matters governed by Regulation (EC) No 302/2009 and, in particular, Article 33 thereof on enforcement measures and Annex VIII on vessel monitoring system (VMS) transmission. It is therefore not necessary to include those provisions in this Regulation. (20) In accordance with Implementing Regulation (EU) No 404/2011, the conversion factors adopted by the SCRS apply to calculate the equivalent round weight of processed bluefin tuna, including for the purpose of this Regulation. (21) Moreover, in accordance with Article 95 of Regulation (EC) No 1224/2009, Commission Implementing Decision 2014/156/EU (14) has been adopted. That Implementing Decision establishes, inter alia, target benchmarks and objectives for the control of the bluefin tuna fishery in the eastern Atlantic and the Mediterranean. (22) ICCAT Recommendation 06-07 set up a sampling programme for the estimation of the number-at-size in the context of bluefin tuna farming activities. That provision was implemented by Article 10 of Regulation (EC) No 302/2009. It is not necessary that this Regulation specifically provides for the sampling programme, as the needs of that sampling programme are now fully covered by the programmes set up by paragraph 83 of Recommendation 14-04, which is to be implemented by this Regulation. (23) For reasons of clarity, simplification and legal certainty, Regulation (EC) No 302/2009 should therefore be repealed. (24) For the purpose of the Union's compliance with its international obligations under the Convention, Delegated Regulation (EU) 2015/98 provides for derogations from the landing obligation for bluefin tuna set out in Article 15 of Regulation (EU) No 1380/2013. Delegated Regulation (EU) 2015/98 implements certain provisions of ICCAT Recommendation 13-07 that establish a discard and release obligation for vessels and traps catching bluefin tuna in the eastern Atlantic and the Mediterranean in certain cases. This Regulation therefore does not need to cover such discard and release obligations and will consequently be without prejudice to the corresponding provisions of Delegated Regulation (EU) 2015/98, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation lays down the general rules for the application by the Union of the recovery plan as defined in point (1) of Article 3. 2. This Regulation applies to bluefin tuna (Thunnus thynnus) in the eastern Atlantic and the Mediterranean. Article 2 Objective The objective of this Regulation, in accordance with the recovery plan as defined in point (1) of Article 3, is to achieve a biomass of bluefin tuna corresponding to the maximum sustainable yield by 2022 with at least a 60 % probability of achieving that objective. Article 3 Definitions For the purpose of this Regulation, the following definitions apply: (1) \u2018recovery plan\u2019 means the multiannual recovery plan for bluefin tuna, which applies from 2007 to 2022 and was recommended by ICCAT; (2) \u2018fishing vessel\u2019 means any powered vessel used or intended for use for the purposes of the commercial exploitation of bluefin tuna resources, including catching vessels, processing vessels, support vessels, towing vessels, vessels engaged in transhipment and transport vessels equipped for the transportation of tuna products and auxiliary vessels, except container vessels; (3) \u2018catching vessel\u2019 means a vessel used for the purposes of the commercial capture of bluefin tuna resources; (4) \u2018processing vessel\u2019 means a vessel on board of which fisheries products are subject to one or more of the following operations, prior to their packaging: filleting or slicing, freezing and/or processing; (5) \u2018auxiliary vessel\u2019 means any vessel used to transport dead bluefin tuna (not processed) from a transport/farming cage, a purse seine net or a trap to a designated port and/or to a processing vessel; (6) \u2018towing vessel\u2019 means any vessel used for towing cages; (7) \u2018support vessel\u2019 means any other fishing vessel referred to under point (2); (8) \u2018fishing actively\u2019 means, for any catching vessel and trap, the fact that it targets bluefin tuna during a given fishing season; (9) \u2018joint fishing operation\u2019 means any operation between two or more purse seiners where the catch of one purse seiner is attributed to one or more other purse seiners in accordance with an allocation key; (10) \u2018transfer operations\u2019 means: (i) any transfer of live bluefin tuna from the catching vessel's net to the transport cage; (ii) any transfer of live bluefin tuna from the transport cage to another transport cage; (iii) any transfer of the cage with bluefin tuna from a towing vessel to another towing vessel; (iv) any transfer of live bluefin tuna from one farm to another; (v) any transfer of live bluefin tuna from the trap to the transport cage; (11) \u2018control transfer\u2019 means any additional transfer being implemented at the request of the fishing/farming operators or the control authorities for the purpose of verifying the number of fish being transferred; (12) \u2018trap\u2019 means fixed gear anchored to the bottom, usually containing a guide net that leads bluefin tuna into an enclosure or series of enclosures where it is kept prior to harvesting; (13) \u2018caging\u2019 means the transfer of live bluefin tuna from the transport cage or trap to the farming cages; (14) \u2018farming\u2019 means caging of bluefin tuna in farms and subsequent feeding aiming to fatten and increase their total biomass; (15) \u2018farm\u2019 means an installation used for the farming of bluefin tuna caught by traps and/or purse seiners; (16) \u2018harvesting\u2019 means the killing of bluefin tuna in farms or traps; (17) \u2018transhipment\u2019 means the unloading of all or any of the fish on board a fishing vessel to another fishing vessel. Unloading of dead bluefin tuna from the purse seiner net or the towing vessel to an auxiliary vessel shall not be considered as a transhipment; (18) \u2018sport fishery\u2019 means non-commercial fisheries whose members adhere to a national sport organisation or are issued with a national sport licence; (19) \u2018recreational fishery\u2019 means non-commercial fisheries whose members do not adhere to a national sport organisation and are not issued with a national sport licence; (20) \u2018stereoscopic camera\u2019 means a camera with two or more lenses, with a separate image sensor or film frame for each lens, enabling the taking of three-dimensional images; (21) \u2018control camera\u2019 means a stereoscopic camera and/or conventional video camera for the purpose of the controls provided for in this Regulation; (22) \u2018BCD\u2019 or \u2018electronic BCD\u2019 means a bluefin catch document for bluefin tuna. As appropriate, the reference to BCD shall be replaced by eBCD; (23) \u2018responsible Member State\u2019 or \u2018Member State responsible\u2019 means the flag Member State or the Member State in whose jurisdiction the trap or farm is located or, if the farm or trap is located on the high seas, the Member State where the trap or farm operator is established; (24) \u2018Task II\u2019 means Task II as defined by ICCAT in the \u2018Field manual for statistics and sampling Atlantic tunas and tuna-like fish\u2019 (third edition, ICCAT, 1990); (25) \u2018CPC\u2019 means Contracting Parties to the Convention and cooperating non-contracting parties, entities or fishing entities; (26) \u2018Convention area\u2019 means the geographical area covered by ICCAT measures as set out in Article 1 of the Convention. Article 4 Length of vessels Lengths of vessels referred to in this Regulation shall be understood as overall lengths. CHAPTER II MANAGEMENT MEASURES Article 5 Conditions associated with management measures 1. Each Member State shall take the necessary measures to ensure that the fishing effort of its catching vessels and its traps are commensurate with the bluefin tuna fishing opportunities available to that Member State in the eastern Atlantic and the Mediterranean. 2. The carrying-over of any unused quota shall be prohibited. 3. The chartering of Union fishing vessels for bluefin tuna fishing in the eastern Atlantic and the Mediterranean shall be prohibited. Article 6 Submission of annual fishing plans, fishing capacity management plans and farming management plans 1. By 31 January each year, each Member State with a bluefin tuna quota shall transmit to the Commission: (a) an annual fishing plan for the catching vessels and traps fishing bluefin tuna in the eastern Atlantic and the Mediterranean; (b) an annual fishing capacity management plan ensuring that the Member State's fishing capacity is commensurate with its allocated quota. 2. The Commission shall compile the plans referred to in paragraph 1 and integrate them into the Union fishing and capacity management plan. The Commission shall transmit that plan to the ICCAT Secretariat by 15 February of each year for discussion and approval by ICCAT. 3. By 15 April of each year, each Member State that intends to modify the ICCAT plan for farming capacity in force shall transmit an annual farming management plan to the Commission, which shall transmit it to the ICCAT Secretariat. Article 7 Annual fishing plans 1. The annual fishing plan submitted by each Member State with a bluefin tuna quota shall identify the quotas allocated to each gear group referred to in Articles 11 and 12, including information on: (a) for catching vessels over 24 metres included in the vessel list referred to in point (a) of Article 20(1) \u2014 the individual quota allocated to them and the measures in place to ensure compliance with the individual quotas and by-catch allowances; (b) for catching vessels less than 24 metres and for traps \u2014 at least the quota allocated to producer organisations or groups of vessels fishing with a similar gear type. 2. By way of derogation from point (a) of paragraph 1, the individual quota allocated to each catching vessel over 24 metres may be submitted not later than 30 days before the start of the fishing season applicable to each such vessel. 3. Any subsequent modification to the annual fishing plan or the individual quotas allocated for catching vessels over 24 metres and included in the list referred to in point (a) of Article 20(1) shall be transmitted by the Member State concerned to the Commission at least three days before the exercise of the activity corresponding to that modification. The Commission shall transmit such modification to the ICCAT Secretariat at least 48 hours before the exercise of the activity corresponding to that modification. Article 8 Allocation of fishing opportunities In accordance with Article 17 of Regulation (EU) No 1380/2013, when allocating the fishing opportunities available to them, Member States shall use transparent and objective criteria, including those of an environmental, social and economic nature, and shall also endeavour to distribute national quotas fairly among the various fleet segments giving consideration to traditional and artisanal fisheries, and to provide incentives to Union fishing vessels deploying selective fishing gear or using fishing techniques with reduced environmental impact. Article 9 Fishing capacity management plans 1. The annual fishing capacity management plan submitted by each Member State with a bluefin tuna quota shall comply with the conditions set out in this Article. 2. The maximum number of traps registered in a Member State and of fishing vessels flying the flag of a Member State that may fish for, retain on board, tranship, transport, or land bluefin tuna, shall be determined in accordance with the Treaty on the Functioning of the European Union (\u2018TFEU\u2019) and Article 16 of Regulation (EU) No 1380/2013. 3. The maximum number and the corresponding gross tonnage of fishing vessels flying the flag of a Member State engaged in bluefin tuna fishery shall be limited to the number, and the total corresponding gross tonnage, of fishing vessels flying the flag of that Member State that fished for, retained on board, transhipped, transported or landed bluefin tuna from 1 January 2007 to 1 July 2008. That limit shall apply by gear type for catching vessels. 4. For vessels authorised to fish for bluefin tuna under the derogation referred to in Article 14(2), additional conditions to determine the maximum number of fishing vessels are set out in Annex I. 5. The maximum number of traps of a Member State engaged in bluefin tuna fishery shall be limited to the number of traps authorised by that Member State by 1 July 2008. 6. By way of derogation from paragraphs 3 and 5 of this Article, for the years 2016 and 2017, when a Member State can demonstrate that its fishing capacity might not allow the use of its full quota, that Member State may decide to include a higher number of vessels and traps in its annual fishing plans referred to in Article 7. 7. For the years 2016 and 2017, each Member State shall limit the numbers of its purse seiners to the numbers of purse seiners it authorised in 2013 or 2014. That shall not apply to purse seiners operating under the derogation provided for in point (b) of Article 14(2). 8. When setting up its fishing capacity management plans, calculation of the fishing capacity of each Member State shall be based on the best catch rates per vessel and gear estimated by the SCRS in its Report of 2009 and agreed by ICCAT in the 2010 Inter-sessional meeting of the ICCAT Compliance Committee (15). Following any revisions of those catch rates by the SCRS, Member States shall always apply the most recent catch rates agreed by the ICCAT. Article 10 Farming management plans 1. The annual farming management plan submitted by each Member State shall comply with the conditions set out in this Article. 2. The maximum bluefin tuna farming and fattening capacity for each Member State and the maximum input of wild-caught bluefin tuna that each Member State may allocate shall be determined in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 3. The maximum bluefin tuna farming and fattening capacity of a Member State shall be limited to the bluefin tuna farming and fattening capacity of the farms of that Member State that were registered in the ICCAT record of farming facilities or authorised and declared to ICCAT on 1 July 2008. 4. The maximum input of wild-caught bluefin tuna into the farms of a Member State shall be limited to the level of the input quantities registered with ICCAT by the farms of that Member State in the years 2005, 2006, 2007 or 2008. 5. Within the maximum input quantity of wild-caught bluefin tuna referred to in paragraph 4, each Member State shall allocate maximum annual inputs to its farms. CHAPTER III TECHNICAL MEASURES SECTION 1 Fishing seasons Article 11 Longliners, purse seiners, pelagic trawlers, traps and sport and recreational fisheries 1. Bluefin tuna fishing by large-scale pelagic longline catching vessels over 24 metres shall be permitted in the eastern Atlantic and the Mediterranean from 1 January to 31 May, with the exception of the area delimited by west of 10\u00b0 W and north of 42\u00b0 N as well as of the Norwegian exclusive economic zone, where such fishing shall be permitted from 1 August to 31 January. 2. Purse seine fishing for bluefin tuna shall be permitted in the eastern Atlantic and the Mediterranean from 26 May to 24 June, with the exception of the Norwegian exclusive economic zone, where such fishing shall be permitted from 25 June to 31 October. 3. Bluefin tuna fishing by pelagic trawlers shall be permitted in the eastern Atlantic from 16 June to 14 October. 4. Bluefin tuna sport and recreational fishing shall be permitted in the eastern Atlantic and the Mediterranean from 16 June to 14 October. 5. Fishing for bluefin tuna by gears other than those referred to in paragraphs 1 to 4 of this Article and Article 12, including traps, shall be permitted throughout the year in accordance with ICCAT conservation and management measures. Article 12 Baitboats and trolling boats 1. Bluefin tuna fishing by baitboats and trolling boats shall be permitted in the eastern Atlantic and the Mediterranean from 1 July to 31 October. 2. Provided that the protection of the spawning grounds is not affected and that the total duration of the fishing season for those fisheries does not exceed four months, each Member State may decide on a different starting date for baitboats and trolling boats flying their flag and operating in the eastern Atlantic. 3. Each Member State shall specify, in its annual fishing plan referred to in Article 7, whether the starting dates for those fisheries have been modified, as well as the coordinates of the areas concerned. SECTION 2 Minimum conservation reference size, incidental catch, by-catch Article 13 The landing obligation The provisions of this Section shall be without prejudice to Article 15 of Regulation (EU) No 1380/2013, including any applicable derogations thereto. Article 14 Minimum conservation reference size 1. The minimum conservation reference size for bluefin tuna caught in the eastern Atlantic and the Mediterranean shall be 30 kg or 115 cm fork length. 2. By way of derogation from paragraph 1, a minimum conservation reference size for bluefin tuna of 8 kg or 75 cm fork length shall apply to the following fisheries: (a) bluefin tuna caught in the eastern Atlantic by baitboats and trolling boats; (b) bluefin tuna caught in the Adriatic Sea for farming purposes; (c) bluefin tuna caught in the Mediterranean Sea by the coastal and artisanal fishery for fresh fish by baitboats, longliners and handliners. 3. The specific conditions applying to the derogation referred to in paragraph 2 are set out in Annex I. 4. Member States concerned shall issue specific authorisations to vessels fishing under the derogation referred to in paragraph 2 of this Article. The vessels concerned shall be indicated in the list of catching vessels referred to in point (a) of Article 20(1). For that purpose, the provisions laid down in Articles 20 and 21 shall apply. Article 15 Incidental catches 1. Without prejudice to Article 14(1), incidental catches of a maximum 5 % of bluefin tuna weighing between 8 and 30 kg or with a fork length between 75 and 115 cm shall be allowed for all catching vessels and traps fishing actively for bluefin tuna. 2. The percentage of 5 % referred to in paragraph 1 shall be calculated on the basis of the total catches of bluefin tuna in number of fish retained on board the vessel or inside the trap at any time after each fishing operation. 3. Incidental catches shall be deducted from the quota of the Member State responsible for the catching vessel or trap. 4. Incidental catches of bluefin tuna shall be subject to Articles 25, 30, 31 and 32. Article 16 By-catch 1. Each Member State shall make provision for by-catch of bluefin tuna within its quota and shall inform the Commission thereof when transmitting its fishing plan. Such provision shall ensure that all dead fish are deducted from the quota. 2. Union fishing vessels not fishing actively for bluefin tuna shall avoid by-catches of bluefin tuna exceeding, at any time following a fishing operation, 5 % of the total catch on board by weight or number of fish. The calculation of that percentage by number of fish shall only apply to tuna and tuna-like species managed by ICCAT. Each Member State shall deduct all dead fish within the by-catch from its quota. 3. For Member States without a bluefin tuna quota, the by-catches concerned shall be deducted from the specific Union bluefin tuna by-catch quota established in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 4. If the quota allocated to the Member State of the fishing vessel or trap concerned has already been exhausted, the catching of any bluefin tuna shall be avoided. Dead bluefin tuna shall be landed whole and unprocessed and shall be subject to confiscation and the appropriate follow-up action. In accordance with Article 29, each Member State shall provide information on the quantity of such dead bluefin tuna on an annual basis to the Commission who shall forward it to the ICCAT Secretariat. 5. The procedures referred to in Articles 27, 30, 31, 32 and 56 shall apply to by-catch. SECTION 3 Use of aerial means Article 17 Use of aerial means The use of any aerial means, including aircraft, helicopters or any types of unmanned aerial vehicles for searching for bluefin tuna shall be prohibited. CHAPTER IV SPORT AND RECREATIONAL FISHERIES Article 18 Specific quota for sport and recreational fisheries Each Member State with a bluefin tuna quota shall regulate sport and recreational fisheries by allocating a specific quota for the purpose of those fisheries and shall inform the Commission thereof when transmitting its fishing plan. Article 19 Sport and recreational fisheries 1. Each Member State with a bluefin tuna quota shall regulate sport and recreational fisheries by issuing fishing authorisations to vessels for the purpose of sport and recreational fishing. 2. For sport and recreational fisheries no more than one bluefin tuna shall be caught per vessel per day. 3. Any bluefin tuna landed shall be whole, gilled and/or gutted. Each Member State shall take the necessary measures to ensure, to the greatest extent possible, the release of bluefin tuna, especially juveniles, caught alive in the framework of sport and recreational fishing. 4. The marketing of bluefin tuna caught during sport and recreational fishing shall be prohibited. 5. Each Member State shall record catch data including weight and length of each bluefin tuna caught during sport and recreational fishing and communicate the data for the preceding year to the Commission by 30 June each year. The Commission shall forward that information to the SCRS. 6. Each Member State shall count dead catches from sport and recreational fisheries against the quota it allocated in accordance with Article 7(1) and Article 18. CHAPTER V CONTROL MEASURES SECTION 1 Records of vessels and traps Article 20 Records of vessels 1. Each Member State shall submit electronically each year to the Commission one month before the start of the fishing seasons referred to in Articles 11 and 12, where applicable, and otherwise one month before the start of the period of authorisation: (a) a list of all catching vessels flying its flag authorised to fish actively for bluefin tuna in the eastern Atlantic and the Mediterranean by the issuing of a fishing authorisation; (b) a list of all other fishing vessels, other than catching vessels, flying its flag authorised to operate for bluefin tuna in the eastern Atlantic and the Mediterranean. 2. Both lists shall be set up in accordance with the format set in the Guidelines by ICCAT for submitting the data and information required. 3. During a calendar year, a fishing vessel may be included in both of the lists referred to in paragraph 1 provided that it is not included in both lists at the same time. 4. The lists referred to in paragraph 1 of this Article shall contain the vessel's name and Union fleet register number (CFR) as defined in Annex I to Commission Regulation (EC) No 26/2004 (16). 5. No retroactive submission shall be accepted. Subsequent changes to the lists referred to in paragraph 1 during a calendar year shall only be accepted if the notified fishing vessel is prevented from participating due to legitimate operational reasons or force majeure. In such circumstances, the Member State concerned shall immediately inform the Commission of that fact, and shall provide: (a) full details of the fishing vessel(s) intended to replace a vessel included in the lists referred to in paragraph 1; and (b) a comprehensive account of the reasons justifying the replacement and any relevant supporting evidence or references. 6. The Commission shall send the information referred to in paragraphs 1 and 2 to the ICCAT Secretariat so that the vessels can be entered into the ICCAT record of catching vessels authorised to fish actively for bluefin tuna or in the ICCAT record of all other fishing vessels (catching vessels excluded) authorised to operate for bluefin tuna. 7. Article 8a(2), (6), (7) and (8) of Council Regulation (EC) No 1936/2001 (17) shall apply with the necessary modifications. Article 21 Relationship with Regulation (EC) No 1224/2009 The control measures provided for in this Chapter shall apply in addition to those provided for in Regulation (EC) No 1224/2009, except where otherwise provided for in this Chapter. Article 22 Fishing authorisations for vessels 1. Without prejudice to Article 16, Union fishing vessels not entered into the ICCAT records referred to in Article 20(1) shall not be authorised to fish for, retain on board, tranship, transport, transfer, process or land bluefin tuna in the eastern Atlantic and the Mediterranean. 2. The flag Member State shall withdraw the fishing authorisation for bluefin tuna and may require the vessel to proceed immediately to a port designated by it when the individual quota is deemed to be exhausted. Article 23 Records of traps authorised to fish for bluefin tuna 1. By 15 February each year, each Member State shall send to the Commission electronically a list of its traps authorised, by the issuing of a fishing authorisation, to fish for bluefin tuna in the eastern Atlantic and the Mediterranean. The list shall include the name of the traps and the register number and shall be set up in accordance with the format set in the Guidelines by ICCAT for submitting data and information required. 2. The Commission shall send the list to the ICCAT Secretariat so that those traps can be entered into the ICCAT record of traps authorised to fish for bluefin tuna. 3. Union traps that are not entered into the ICCAT record shall not be authorised to fish for, retain, transfer, cage or land bluefin tuna in the eastern Atlantic and the Mediterranean. 4. Article 8a(2), (4), (6), (7) and (8) of Regulation (EC) No 1936/2001 shall apply with the necessary modifications. Article 24 Joint fishing operation 1. Any joint fishing operation (\u2018JFO\u2019) for bluefin tuna shall only be authorised with the consent of the flag Member State(s) concerned. To be authorised, each purse seiner shall be equipped to fish for bluefin tuna and have an individual quota. JFOs with other CPCs shall not be permitted. 2. Each Member State shall take the necessary measures to obtain the following information from its fishing vessels applying for an authorisation to take part in the JFO: (a) the duration; (b) the identity of the operators involved; (c) the individual vessels' quotas; (d) the allocation key between the fishing vessels for the catches involved; and (e) information on the farms of destination. 3. At least 15 days before the start of the operation, each Member State shall send the information referred to in paragraph 2 to the Commission in the format set out in Annex VI. The Commission shall forward that information to the ICCAT Secretariat and to the flag State of other fishing vessels participating in the JFO at least 10 days before the start of the operation. 4. In the case of force majeure, the deadline set out in paragraph 3 shall not apply for the information requested under point (e) of paragraph 2. In that case, Member States may submit to the Commission an update of that information as soon as possible, together with a description of the events constituting force majeure. The Commission shall forward that information to the ICCAT Secretariat. SECTION 2 Catches Article 25 Recording requirements 1. In addition to complying with Articles 14, 15, 23 and 24 of Regulation (EC) No 1224/2009, the master of a Union catching vessel shall, if applicable, enter into the logbook the information listed in Part A of Annex II to this Regulation. 2. Masters of Union towing vessels, auxiliary vessels and processing vessels shall record their activities in accordance with the requirements set out in Parts B, C and D of Annex II. Article 26 Catch reports sent by masters and trap operators 1. Masters of catching vessels fishing actively for bluefin tuna shall send to the authorities of the flag Member State daily information from logbooks, including the ICCAT register number, the vessel name, the beginning and end of the period of authorisation, date, time, location (latitude and longitude) and the weight and number of bluefin tuna caught in the Convention area. They shall send that information electronically in the format set out in Annex V during the whole period in which the vessel is authorised to fish bluefin tuna. 2. Masters of purse seiners shall produce daily reports as referred to in paragraph 1 on a fishing operation by fishing operation basis, including operations where the catch was zero. 3. The reports referred to in paragraphs 1 and 2 shall be transmitted by the operator to its flag Member State authorities on a daily basis for purse seiners and vessels over 24 metres by 9.00 GMT for the preceding day and for other catching vessels by Monday 24.00 (midnight) for the preceding week ending Sunday 24.00 (midnight) GMT. 4. Trap operators fishing actively for bluefin tuna shall send a daily catch report including the ICCAT register number, date, time, catches (weight and number of fish), including zero catches. They shall send that information within 48 hours electronically in the format set out in Annex V to their Member State authorities during the whole period they are authorised to fish bluefin tuna. 5. The Commission may adopt implementing acts laying down detailed rules for the recording and reporting of vessel and trap activities referred to in paragraphs 1 to 4 of this Article and Annex V. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(2). Article 27 Weekly and monthly catch reports sent by the Member States 1. Each Member State shall, upon receipt of the catch reports referred to in Article 26, promptly forward them electronically to the Commission and shall provide promptly to the Commission weekly catch reports for all catching vessels and traps in accordance with the format set out in Annex V. The Commission shall forward that information on a weekly basis to the ICCAT Secretariat in accordance with the format set out in the Guidelines for submitting data and information required by ICCAT. 2. Each Member State shall inform the Commission, before the 15th day of each month, of the quantities of bluefin tuna caught in the eastern Atlantic and the Mediterranean which have been landed, transhipped, trapped or caged during the preceding month by the fishing vessels or traps flying the flag of or registered in that Member State. The information provided shall be structured by gear type including by-catch, catches in sport and recreational fisheries and zero catches. The Commission shall promptly forward that information to the ICCAT Secretariat. Article 28 Information on quota exhaustion 1. In addition to the provisions of Article 34 of Regulation (EC) No 1224/2009, each Member State shall inform the Commission when the quota allocated to a gear group referred to in Article 11 or Article 12 of this Regulation is deemed to have reached 80 %. 2. In addition to the provisions of Article 35 of Regulation (EC) No 1224/2009, each Member State shall inform the Commission when the quota allocated to a gear group referred to in Article 11 or Article 12 of this Regulation or to a JFO or to a purse seiner is deemed to be exhausted. 3. The information referred to in paragraph 2 shall be accompanied by official documentation proving the fishing stop or the call back to port issued by the Member State for the fleet, the gear group, the JFO, or the vessels with an individual quota including a clear indication of the date and the time of the closure. Article 29 Yearly reporting of catches by the Member States 1. By 15 March each year, each Member State shall submit to the Commission detailed information on any bluefin tuna catches in the eastern Atlantic and the Mediterranean in the preceding fishing year. That information shall include: (a) the name and ICCAT number of each catching vessel; (b) the period of authorisation(s) for each catching vessel; (c) the total catches of each catching vessel including when the catch was zero throughout the period of authorisation(s); (d) the total number of days each catching vessel fished in the eastern Atlantic and the Mediterranean throughout the period of authorisation(s); and (e) the total catch of each catching vessel outside the period of authorisation (by-catch), including when the catch was zero. 2. For vessels not authorised to fish actively for bluefin tuna in the eastern Atlantic and the Mediterranean but which caught bluefin tuna as by-catch, the information to be submitted to the Commission at the same date as referred to in paragraph 1 shall include: (a) the name and ICCAT number or national registry number of the vessel, if not registered with ICCAT; and (b) the total catches of bluefin tuna. 3. Each Member State shall notify to the Commission any information on vessels not subject to paragraphs 1 and 2 but known or presumed to have fished for bluefin tuna in the eastern Atlantic and the Mediterranean. 4. The Commission shall transmit to the ICCAT Secretariat the information received under paragraphs 1, 2 and 3. SECTION 3 Landings and transhipments Article 30 Designated ports 1. Each Member State shall designate ports or places close to the shore (designated ports) where landing or transhipping operations of bluefin tuna are permitted. 2. For a port to be determined as a designated port, the port Member State shall specify permitted landing and transhipping times and places. 3. By 15 February of each year, each Member State shall transmit a list of designated ports to the Commission which shall transmit that information to the ICCAT Secretariat. 4. It shall be prohibited to land or tranship from fishing vessels any quantity of bluefin tuna fished in the eastern Atlantic and the Mediterranean at any place other than ports or places close to the shore designated by CPCs and Member States in accordance with paragraphs 1 and 2. Article 31 Landings 1. Article 17 of Regulation (EC) No 1224/2009 shall apply to masters of Union fishing vessels of 12 metres' length overall or more included in the list of vessels referred to in Article 20 of this Regulation. The prior arrival notification under Article 17 of Regulation (EC) No 1224/2009 shall be sent to the competent authority of the Member State (including the flag Member State) or CPC whose ports or landing facility they wish to use. 2. In addition, masters of Union fishing vessels under 12 metres' length overall included in the list of vessels referred to in Article 20 shall, at least four hours before the estimated time of arrival at the port, notify the competent authority of the Member State (including the flag Member State) or the CPC whose ports or landing facility they wish to use, at least of the following: (a) estimated time of arrival; (b) estimated quantity of bluefin tuna retained on board; and (c) information on the geographical area where the catches were taken. 3. Where Member States are authorised under applicable Union legislation to apply a shorter notification period than that referred to in paragraphs 1 and 2, the estimated quantities of bluefin tuna retained on board may be notified at the thus applicable time of notification prior to arrival. If the fishing grounds are less than four hours from the port, the estimated quantities of bluefin tuna retained on board may be modified at any time prior to arrival. 4. Authorities of the port Member State shall keep a record of all prior notifications for the current year. 5. All landings shall be controlled, in accordance with Article 55(2), by the relevant control authorities of the port Member State and a percentage shall be inspected based on a risk assessment system involving quota, fleet size and fishing effort. Full details of such control system adopted by each Member State shall be detailed in the annual inspection plan referred to in Article 53. That control system shall also apply to harvest operations. 6. In addition to Article 23(1) of Regulation (EC) No 1224/2009, after each trip, masters of a Union catching vessel, whatever the length of the vessel, shall submit a landing declaration to the competent authorities of the flag Member State and, if the landing has taken place in a port of another Member State or CPC, to the competent authorities of the port Member State or CPC concerned. 7. All landed catches shall be weighed. Article 32 Transhipment 1. Transhipment at sea of bluefin tuna in the Convention area shall be prohibited in all circumstances. 2. Fishing vessels shall only tranship bluefin tuna catches in designated ports under the conditions set out in Article 30. 3. The port Member State shall ensure full inspection coverage during all transhipping times and at all transhipping places. 4. Prior to entry into any port, the masters or representatives of the receiving fishing vessels shall, at least 48 hours before the estimated time of arrival, provide the competent authorities of the Member State or CPC whose port they want to use with the following: (a) estimated date and time of arrival, and port of arrival; (b) estimated quantity of bluefin tuna retained on board, and information on the geographical area where it was taken; (c) the name of the transhipping fishing vessel and its number in the ICCAT record of catching vessels authorised to fish actively for bluefin tuna or in the ICCAT record of other fishing vessels authorised to operate for bluefin tuna in the eastern Atlantic and the Mediterranean; (d) the name of the receiving fishing vessel, its number in the ICCAT record of catching vessels authorised to fish actively for bluefin tuna or in the ICCAT record of other fishing vessels authorised to operate for bluefin tuna in the eastern Atlantic and the Mediterranean; and (e) the tonnage and the geographical area of the catch of bluefin tuna to be transhipped. 5. Fishing vessels shall not be allowed to tranship unless they have obtained prior authorisation from their flag State. 6. Masters of transhipping fishing vessels shall, before the transhipment starts, inform their flag State of the following: (a) the quantities of bluefin tuna to be transhipped; (b) the date and port of the transhipment; (c) the name, registration number and flag of the receiving fishing vessel and its number in the ICCAT record of catching vessels authorised to fish actively for bluefin tuna or in the ICCAT record of other fishing vessels authorised to operate for bluefin tuna in the eastern Atlantic and the Mediterranean; and (d) the geographical area of the catch of bluefin tuna. 7. All transhipments shall be inspected by the competent Member State authorities at the designated port. Those authorities shall: (a) inspect the receiving fishing vessel on arrival and check the cargo and documentation related to the transhipment operation; (b) send a record of the transhipment to the flag State authority of the transhipping fishing vessel, within five days after the transhipment has ended. 8. By way of derogation from Articles 21 and 22 of Regulation (EC) No 1224/2009, masters of a Union fishing vessel shall, whatever the length of the vessel, complete and send the ICCAT transhipment declaration to the competent authorities of the Member State whose flag the fishing vessel is flying. The declaration shall be transmitted no later than 48 hours after the date of transhipment in port in accordance with the format set out in Annex III to this Regulation. SECTION 4 Transfer operations Article 33 Transfer authorisation 1. Before any transfer operation, the master of a catching vessel or towing vessel or the operator of the farm or trap where the transfer in question originates shall send to the competent authorities of the relevant Member State a prior notification of transfer indicating: (a) the name of the catching vessel, towing vessel, farm or trap and the ICCAT register number; (b) the estimated time of transfer; (c) the estimate of the quantity of bluefin tuna to be transferred; (d) information on the position (latitude/longitude) where the transfer will take place as well as the identifiable cage numbers; (e) the name of the receiving towing vessel, the number of cages towed and, where appropriate, the ICCAT register number; (f) the port, farm or cage of destination of the bluefin tuna. 2. For the purpose referred to in paragraph 1, a unique cage number shall be assigned to each cage. Numbers shall be issued with a unique numbering system that includes at least three alfa-code letters corresponding to the flag of the towing vessel followed by three numbers. 3. Catching vessels, towing vessels, farms or traps shall not be allowed to transfer unless they have obtained prior authorisation from the relevant Member State. The authorities of that Member State shall decide for each transfer operation whether to grant authorisation. For that purpose, a unique identification number shall, for each transfer operation, be assigned and communicated to the master of the fishing vessel, the trap operator or the farm operator, as appropriate. Where authorisation is granted, that number shall comprise the three-letter code of the Member State, the four numbers indicating the year, and the three letters \u2018AUT\u2019 (authorisation), followed by sequential numbers. Where authorisation is refused, the number shall comprise the three-letter code of the Member State, the four numbers indicating the year, and the three letters \u2018NEG\u2019 (non-authorisation), followed by sequential numbers. 4. In the event that fish die during the transfer operation, the relevant Member States and operators involved in the transfer shall proceed in accordance with Annex XII. 5. The transfer authorisation shall be granted or refused by the Member State responsible for the catching vessel, towing vessel, farm or trap, as appropriate, within 48 hours following the submission of the prior notification of transfer. 6. The authorisation for transfer by the relevant Member State shall not prejudge the authorisation of the caging operation. Article 34 Refusal of transfer authorisation 1. The Member State responsible for the vessel, trap or farm shall not authorise the transfer if, on receipt of the prior notification of transfer, it considers that: (a) the catching vessel or the trap that is declared to have caught the fish does not have sufficient quota; (b) the quantity of fish has not been duly reported by the catching vessel or the trap operator or has not been authorised to be caged, or has not been taken into account for the consumption of the quota that may be applicable; (c) the catching vessel or trap that is declared to have caught the fish is not authorised to fish for bluefin tuna; or (d) the towing vessel declared to be the one to receive the transfer of fish is not registered in the ICCAT record of all other fishing vessels (catching vessels excluded) authorised to operate for bluefin tuna, as referred to in point (b) of Article 20(1), or is not equipped with a VMS. 2. If the transfer is not authorised: (a) the Member State responsible for the catching vessel or trap shall issue a release order to the master of the catching vessel or to the operator of the trap or farm as appropriate and inform them that the transfer is not authorised and that the fish have to be released into the sea; (b) the master of the catching vessel, the farm operator or the trap operator, as appropriate, shall release the fish; (c) the release of bluefin tuna shall be carried out in accordance with the procedures set out in Annex XI. Article 35 Monitoring by video camera 1. For transfer operations, the master of the catching vessel, towing vessel, farm operator or trap operator that transfers bluefin tuna shall ensure that the transfer operations are monitored by video camera in the water in order to verify the number of fish being transferred. The minimum standards and procedures for video recording shall be in accordance with Annex IX. 2. Each Member State responsible for the vessel, trap or farm shall ensure that the video records referred to in paragraph 1 are made available to the ICCAT inspectors and regional observers. 3. Each Member State responsible for the vessel, trap or farm shall ensure that the video records referred to in paragraph 1 are made available to Union inspectors and national observers. 4. Each Member State responsible for the vessel, trap or farm shall take the necessary measures to avoid any replacement, editing or manipulation of the original video record. Article 36 Verification by ICCAT regional observers and launching and conduct of investigation 1. ICCAT regional observers on board the catching vessel or present at a trap, as set out in Article 51 and Annex VII, shall record and report on the transfer operations carried out, observe and estimate catches transferred and verify entries made in the prior transfer authorisation referred to in Article 33 and in the ICCAT transfer declaration referred to in Article 38. 2. In cases where there is more than 10 % difference by number between the estimates of catch made by the ICCAT regional observer, relevant control authorities and/or the master of the catching vessel, or representative of the trap, or where the video record is of insufficient quality or clarity to make such estimations, the Member State responsible for the catching vessel, farm or trap shall launch an investigation which shall be concluded prior to the time of caging at the farm or in any case within 96 hours after being launched. Pending the results of that investigation, caging shall not be authorised and the catch section of the bluefin tuna catch document (\u2018BCD\u2019) shall not be validated. 3. However, when the video record is of insufficient quality or clarity to estimate the number, the operator may request authorisation from the flag State authorities of the vessel, trap or farm to conduct a new transfer operation and to provide the corresponding video record to the ICCAT regional observer. 4. Without prejudice to the verifications conducted by an inspector, ICCAT regional observers shall sign the ICCAT transfer declaration only when their observations are in accordance with the ICCAT conservation and management measures and when the information contained in the transfer declaration is consistent with their observations including a compliant video record as required under Article 35(1). They shall sign that declaration with clearly written name and ICCAT number. 5. ICCAT regional observers shall also verify that the ICCAT transfer declaration is transmitted to the master of the towing vessel or to the farm or trap representative. Article 37 Measures to estimate the number and weight of bluefin tuna to be caged Member States shall take the necessary measures and actions to further explore methodologies to improve the estimate of both the number and weight of bluefin tuna at the point of capture and caging. Each Member State shall report on the measures taken by 22 August of each year to the Commission who shall submit those reports to the SCRS. Article 38 Transfer declaration 1. Masters of catching or towing vessels, trap operators or farm operators shall, at the end of the transfer operation, complete and transmit to the competent authorities of their Member State the ICCAT transfer declaration, in accordance with the format set out in Annex IV. 2. Transfer declaration forms shall be numbered by the competent authorities of the Member State responsible for the vessels, farms or traps from which the transfers originate. The numbering system shall include the three-letter code of the Member State, followed by the four numbers indicating the year and three sequential numbers followed by the three letters \u2018ITD\u2019 (MS-20**/xxx/ITD). 3. The original transfer declaration shall accompany the transfer of the fish. A copy of the declaration shall be kept by the master of the catching vessel, the trap operator, the master of the towing vessel or the farm operator. 4. Masters of vessels carrying out transfer operations (including towing vessels) shall report their activities in accordance with the requirements set out in Annex II. Article 39 Implementing acts The Commission may adopt implementing acts laying down detailed rules for transfer operations referred to in Articles 33 to 38 and the Annexes referred to in those Articles. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(2). SECTION 5 Caging operations Article 40 Caging authorisation 1. Prior to the start of each caging operation the anchoring of transport cages within 0,5 nautical miles of farming facilities shall be prohibited. 2. Before any caging operation, the competent authority of the Member State responsible for the farm shall inform the Member State or CPC responsible for the catching vessel or trap of the quantities caught by that vessel or trap and request a caging authorisation. 3. The caging operation shall not begin without the prior authorisation by: (a) the Member State or CPC responsible for the catching vessel or trap; or (b) the Member State or CPC responsible for the farm if it has been agreed among the Member States involved or with the flag CPC involved. 4. The caging authorisation shall be granted or refused by the Member State or CPC responsible for the catching vessel, trap or, if applicable, farm, within one working day following the request and the submission of the information referred to in paragraph 2. If no response is received within one working day from the Member State or CPC responsible for the catching vessel or trap, the Member State or CPC responsible for the farm may authorise the caging. 5. Bluefin tuna shall be caged before 15 August, unless the Member State or CPC responsible for the farm receiving the fish provides duly justified reasons. Such reasons shall be submitted with the caging report. Article 41 Refusal of caging authorisation 1. The Member State responsible for the catching vessel, trap or, if applicable, farm, shall refuse the caging authorisation if it considers, on receipt of the information referred to in Article 40(2), that: (a) the catching vessel or trap that is declared to have caught the fish did not have sufficient quota for the bluefin tuna that were put into the cage; (b) the quantity of fish has not been duly reported by the catching vessel or trap or has not been taken into account for the calculation of the quota applicable; or (c) the catching vessel or trap that is declared to have caught the fish is not authorised to fish for bluefin tuna. 2. If the caging is not authorised, the Member State or CPC responsible for the catching vessel shall request the Member State or CPC responsible for the farm to seize the catches and to release the fish by issuing a release order. 3. Upon receipt of the release order, the farm operator shall proceed with the releases in accordance with Annex XI. Article 42 Bluefin tuna catch documentation Member States responsible for farms shall prohibit any placing of bluefin tuna in cages for the purpose of farming that is not accompanied by the documentation required by ICCAT and in accordance with Regulation (EU) No 640/2010 of the European Parliament and of the Council (18). The documentation shall be accurate, complete and confirmed and validated by the Member State or CPC authorities of the catching vessels or traps. Article 43 Inspections Member States responsible for farms shall take the necessary measures to inspect each caging operation in the farms. Article 44 Monitoring by video camera 1. Each Member State responsible for the farm shall ensure that caging operations are monitored by video camera in the water. A video record shall be produced for each caging operation in accordance with Annex IX. 2. Each Member State responsible for the farm shall ensure that the video records referred to in paragraph 1 are made available to the ICCAT inspectors and regional observers. 3. Each Member State responsible for the farm shall ensure that the video records referred to in paragraph 1 are made available to Union inspectors and national observers. 4. Each Member State responsible for the farm shall take the necessary measures to avoid any replacement, editing or manipulation of the original video record. Article 45 Launching and conduct of investigations 1. Where there is a difference of more than 10 % in the number of bluefin tuna between the estimates made by the ICCAT regional observer, the relevant Member State control authorities or the farm operator, the Member State responsible for the farm shall, in cooperation with the Member State or CPC responsible for the catching vessel or trap, launch an investigation. 2. Pending the results of that investigation, harvesting shall not take place and the farming section of the BCD shall not be validated. 3. The Member States responsible for the farm and for the catching vessel or trap which undertake the investigations may use other information at their disposal including the results of the programmes referred to in Article 46 to conclude the investigation. Article 46 Measures and programmes to estimate the number and weight of bluefin tuna to be caged 1. Member States shall take the necessary measures and actions as referred to in Article 37. 2. A programme using stereoscopic camera systems or alternative techniques that provide the equivalent precision shall cover 100 % of the caging operations in order to refine the number and weight of the fish in each caging operation. 3. That programme shall be implemented in accordance with the procedures set out in Section B of Annex X. 4. The results of that programme shall be communicated by the Member State responsible for the farm to the Member State or CPC responsible for the catching vessel or trap and to the Commission in accordance with Section B of Annex X. The Commission shall transmit them to the ICCAT Secretariat for transmission to the ICCAT regional observer. 5. When the results of the programme indicate that the quantities of bluefin tuna being caged differ from the quantities reported caught and transferred, the Member State responsible for the farm shall, in cooperation with the Member State or CPC responsible for the catching vessel or trap, launch an investigation. If the investigation is not concluded within 10 working days from the communication of the results referred to in paragraph 4 of this Article or if the outcome of the investigation indicates that the number or average weight of bluefin tuna is in excess of that reported caught and transferred, the flag Member State or CPC authorities of the catching vessel or trap shall issue a release order for the excess which must be released in accordance with the procedures laid down in Annex XI. 6. In accordance with the procedures set out in point 3 of Section B of Annex X and following the release, if applicable, the quantities derived from the programme shall be used to: (a) determine the final catch figures to be deducted from the national quota; (b) fill in those figures in the caging declarations and relevant sections of the BCD. 7. Each Member State responsible for the farm shall report on the results of those programmes by 30 August of each year to the Commission who shall submit those reports to the SCRS. 8. The transfer of live bluefin tuna from one farming cage to another farming cage shall not take place without the authorisation and the presence of the farm state control authorities. 9. A difference superior or equal to 10 % between the quantities of bluefin tuna reported caught by the vessel/trap and the quantities established by the control cameras, as referred to in paragraph 5 of this Article and Article 45, shall constitute a potential non-compliance by the vessel/trap concerned and Member States shall take the necessary measures to ensure the appropriate follow-up. Article 47 Caging report 1. Within one week of the completion of the caging operation, the Member State responsible for the farm shall submit a caging report containing the elements set up in Section B of Annex X to the Member State or CPC whose vessels or traps have caught the bluefin tuna, and to the Commission. The report shall also contain the information included in the caging declaration as set out in Article 4b of and Annex Ia to Regulation (EC) No 1936/2001. The Commission shall forward the report to the ICCAT Secretariat. 2. For the purposes of paragraph 1, a caging operation shall not be deemed to be completed until any investigation launched and, if applicable, any release operation ordered, is concluded. Article 48 Implementing acts The Commission may adopt implementing acts laying down detailed rules for caging operations referred to in Articles 40 to 47 and the Annexes referred to in those Articles. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(2). SECTION 6 Monitoring and surveillance Article 49 Vessel monitoring system 1. By way of derogation from Article 9(2) of Regulation (EC) No 1224/2009, the obligation concerning the VMS shall apply to all tug and towing vessels included in the ICCAT record of vessels referred to in Article 20(6) of this Regulation, irrespective of their length. 2. Fishing vessels over 15 metres length that are included in the list of vessels referred to in point (a) of Article 20(1) or in the list of vessels referred to in point (b) of Article 20(1) shall begin to transmit VMS data to ICCAT at least 15 days before the opening of the fishing season and shall continue to transmit those data for at least 15 days after the closure of the fishing season, unless a request is sent in advance to the Commission for the vessel to be removed from the ICCAT record of vessels. 3. For control purposes, the transmission of VMS data from catching vessels that are authorised to fish actively for bluefin tuna shall not be interrupted when vessels are in port. 4. Member States shall ensure that their fisheries monitoring centres forward to the Commission and a body designated by it, in real time and using the format \u2018https data feed\u2019, the VMS messages received from the fishing vessels flying their flag. The Commission shall send those messages electronically to the ICCAT Secretariat. 5. Member States shall ensure that: (a) VMS messages from the fishing vessels flying their flag are forwarded to the Commission at least every two hours; (b) in the event of technical malfunction of the VMS, alternative messages from the fishing vessels flying their flag received under Article 25(1) of Implementing Regulation (EU) No 404/2011 are forwarded to the Commission within 24 hours of receipt by their fisheries monitoring centres; (c) messages forwarded to the Commission are sequentially numbered (with a unique identifier) in order to avoid duplication; (d) messages forwarded to the Commission are in accordance with Article 24(3) of Implementing Regulation (EU) No 404/2011. 6. Each Member State shall take the necessary measures to ensure that all messages made available to its inspection vessels are treated in a confidential manner and are limited to inspection at sea operations. Article 50 National observer programme 1. In respect of vessels active in the bluefin tuna fishery, Member States shall ensure at least the following percentage levels of national observer coverage: (a) 20 % of its pelagic trawlers (over 15 metres); (b) 20 % of its long line vessels (over 15 metres); (c) 20 % of its bait boats (over 15 metres); (d) 100 % of towing vessels; (e) 100 % of harvesting operations from traps. 2. Member States shall issue national observers with an official identification document. 3. The national observer tasks shall be, in particular, to: (a) monitor compliance by fishing vessels and traps with this Regulation; (b) record, and report upon, the fishing activity which shall include the following: (i) amount of catch (including by-catch) that also includes species disposition, such as retained on board or discarded dead or alive; (ii) area of catch by latitude and longitude; (iii) measure of effort (such as the number of sets, number of hooks), as defined in the ICCAT Field Manual for different gears; (iv) date of catch; (c) observe and estimate catches and verify entries made in the logbook; (d) sight and record vessels which may be fishing contrary to ICCAT conservation and management measures. 4. National observers shall also carry out scientific work, such as collecting Task II data as defined by ICCAT, when required by ICCAT, based on the instructions from the SCRS. 5. For the purposes of paragraphs 1 to 4, each Member State shall also ensure: (a) representative temporal and spatial presence of national observers on its vessels and traps to ensure that the Commission receives adequate and appropriate data and information on catch, effort and other scientific and management aspects, taking into account characteristics of the fleets and fisheries; (b) robust data collection protocols; (c) that national observers are properly trained and approved before deployment; (d) to the extent possible, minimal disruption to the operations of fishing vessels and traps fishing in the Convention Area. 6. Data and information collected under each Member State's observer programme shall be provided to the Commission by 15 July each year. The Commission shall forward that data and information to the SCRS and the ICCAT Secretariat, as appropriate. Article 51 ICCAT regional observer programme 1. The ICCAT regional observer programme as set out in paragraphs 2 to 6 and as further specified in Annex VII shall apply in the Union. 2. Member States shall ensure that an ICCAT regional observer is present: (a) on all purse seiners authorised to fish bluefin tuna; (b) during all transfers of bluefin tuna from purse seiners; (c) during all transfers of bluefin tuna from traps to transport cages; (d) during all transfers from one farm to another; (e) during all caging operations of bluefin tuna in farms; (f) during all harvesting of bluefin tuna from farms. 3. Purse seiners without an ICCAT regional observer shall not be authorised to fish or to operate in the bluefin tuna fishery. 4. Member States responsible for farms shall ensure an ICCAT regional observer's presence during all caging operations and all harvesting of fish from those farms. 5. The tasks of ICCAT regional observers shall be, in particular, to: (a) observe and monitor that fishing and farming operations are in compliance with the relevant ICCAT conservation and management measures; (b) sign the ICCAT transfer declarations referred to in Article 38, caging reports referred to in Article 47 and BCDs when they agree that the information contained therein is consistent with their observations; (c) carry out scientific work, such as collecting samples, as required by ICCAT, based on the instructions from the SCRS. 6. The flag Member State shall ensure that masters, crew, farm, trap and vessel owners do not obstruct, intimidate, interfere with, influence, bribe or attempt to bribe ICCAT regional observers in the performance of their duties. SECTION 7 Inspections and cross-checks Article 52 ICCAT Scheme of Joint International Inspection 1. The ICCAT Scheme of Joint International Inspection (\u2018the ICCAT scheme\u2019) set out in Annex VIII shall apply in the Union. 2. Member States whose fishing vessels are authorised to fish bluefin tuna in the eastern Atlantic and the Mediterranean shall assign inspectors and carry out inspections at sea under the ICCAT scheme. 3. If, at any time, more than 15 fishing vessels flagged to a Member State are engaged in bluefin tuna fishing activities in the Convention area, that Member State shall deploy an inspection vessel for the purpose of inspection and control at sea in the Convention area throughout the period that those vessels are there. That obligation shall be deemed to have been complied with where Member States cooperate to deploy an inspection vessel or where a Union inspection vessel is deployed in the Convention area. 4. The Commission or a body designated by it may assign Union inspectors to the ICCAT scheme. 5. The Commission or a body designated by it shall coordinate the surveillance and inspection activities for the Union. The Commission may draw up, in coordination with the Member States concerned, joint inspection programmes to enable the Union to fulfil its obligation under the ICCAT scheme. Member States whose fishing vessels are engaged in the fishery of bluefin tuna shall adopt the necessary measures to facilitate the implementation of those programmes particularly as regards the human and material resources required and the periods and geographical areas when those resources are to be deployed. 6. Member States shall inform the Commission by 1 April of each year of the names of the inspectors and the inspection vessels they intend to assign to the ICCAT scheme during the year. Using that information, the Commission shall draw up, in collaboration with the Member States, a plan for the Union participation in the ICCAT scheme each year, which it shall send to the ICCAT Secretariat and the Member States. Article 53 Transmission of inspection plans 1. By 31 January each year, Member States shall transmit their inspection plans to the Commission. The inspection plans shall be set up in accordance with: (a) the objectives, priorities, and procedures as well as benchmarks for inspection activities set up in the Specific control and inspection programme for bluefin tuna in the eastern Atlantic and the Mediterranean established under Article 95 of Regulation (EC) No 1224/2009; (b) the National control action programme for bluefin tuna in the eastern Atlantic and the Mediterranean established under Article 46 of Regulation (EC) No 1224/2009. 2. The Commission shall compile the national inspection plans and integrate them into the Union inspection plan. That plan shall be transmitted by the Commission to the ICCAT Secretariat, for endorsement by ICCAT, together with the plans referred to in Article 6(1). Article 54 Inspections in case of infringements 1. The flag Member State shall take the action under paragraph 2 of this Article if a vessel flying its flag has: (a) failed in its reporting requirement referred to in Articles 25 and 26; or (b) committed an infringement of the provisions of this Regulation, Articles 89 to 93 of Regulation (EC) No 1224/2009 or Chapter IX of Regulation (EC) No 1005/2008. 2. The flag Member State shall ensure that a physical inspection takes place under its authority in its ports or by another person designated by the flag Member State when the vessel is not in one of its ports. Article 55 Cross-check 1. Each Member State shall verify, including by using inspection reports, observer reports and VMS data, the submission of logbooks and relevant information recorded in the logbooks of its fishing vessels, transfer or transhipment documents and BCDs, in accordance with Article 109 of Regulation (EC) No 1224/2009. 2. Each Member State shall carry out cross-checks on all landings, transhipments or cagings between the quantities by species recorded in the fishing vessels logbook or quantities by species recorded in the transfer or transhipment declaration and the quantities recorded in the landing declaration or caging declaration, and any other relevant document, such as an invoice and/or sales notes, in accordance with Article 109 of Regulation (EC) No 1224/2009. SECTION 8 Marketing Article 56 Marketing measures 1. Without prejudice to Regulations (EC) No 1224/2009, (EC) No 1005/2008 and Regulation (EU) No 1379/2013 of the European Parliament and of the Council (19), Union trade, landing, import, export, placing in cages for fattening or farming, re-export and transhipment of bluefin tuna that are not accompanied by accurate, complete and validated documentation set out in this Regulation, Regulation (EU) No 640/2010 and Article 4b of Regulation (EC) No 1936/2001, shall be prohibited. 2. Union trade, import, landing, placing in cages for fattening or farming, processing, export, re-export and transhipment of bluefin tuna shall be prohibited if: (a) the bluefin tuna was caught by fishing vessels or traps whose flag State does not have a quota, catch limit or allocation of fishing effort for bluefin tuna in the eastern Atlantic and the Mediterranean, under the terms of ICCAT conservation and management measures; or (b) the bluefin tuna was caught by a fishing vessel or a trap whose individual quota or whose state's fishing opportunities were exhausted at the time of the catch. 3. Without prejudice to Regulations (EC) No 1224/2009, (EC) No 1005/2008 and (EU) No 1379/2013, Union trade, imports, landings, processing and exports of bluefin tuna from fattening or farming farms that do not comply with the Regulations referred to in paragraph 1 shall be prohibited. CHAPTER VI FINAL PROVISIONS Article 57 Evaluation Member States shall submit to the Commission by 15 September each year a detailed report on their implementation of this Regulation. Based on the information received from Member States, the Commission shall submit by 15 October each year to the ICCAT Secretariat a detailed report on the implementation of ICCAT Recommendation 14-04. Article 58 Financing For the purposes of Regulation (EU) No 508/2014 of the European Parliament and of the Council (20), the multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean shall be deemed to be a multiannual plan within the meaning of Article 9 of Regulation (EU) No 1380/2013. Article 59 Implementation 1. The Commission shall be assisted by the Committee for Fisheries and Aquaculture established by Article 47 of Regulation (EU) No 1380/2013. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 60 Repeal 1. Regulation (EC) No 302/2009 is hereby repealed. 2. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex XIII. Article 61 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 14 September 2016. For the European Parliament The President M. SCHULZ For the Council The President I. KOR\u010cOK (1) OJ C 383, 17.11.2015, p. 100. (2) Position of the European Parliament of 23 June 2016 (not yet published in the Official Journal) and decision of the Council of 18 July 2016. (3) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (4) International Convention for the Conservation of Atlantic Tunas (OJ L 162, 18.6.1986, p. 34). (5) Council Regulation (EC) No 1559/2007 of 17 December 2007 establishing a multi-annual recovery plan for bluefin tuna in the Eastern Atlantic and Mediterranean and amending Regulation (EC) No 520/2007 (OJ L 340, 22.12.2007, p. 8). (6) Council Regulation (EC) No 302/2009 of 6 April 2009 concerning a multiannual recovery plan for bluefin tuna in the eastern Atlantic and Mediterranean, amending Regulation (EC) No 43/2009 and repealing Regulation (EC) No 1559/2007 (OJ L 96, 15.4.2009, p. 1). (7) Regulation (EU) No 500/2012 of the European Parliament and of the Council of 13 June 2012 amending Council Regulation (EC) No 302/2009 concerning a multiannual recovery plan for bluefin tuna in the eastern Atlantic and Mediterranean (OJ L 157, 16.6.2012, p. 1). (8) Regulation (EU) No 544/2014 of the European Parliament and of the Council of 15 May 2014 amending Council Regulation (EC) No 302/2009 concerning a multiannual recovery plan for Bluefin tuna in the eastern Atlantic and Mediterranean (OJ L 163, 29.5.2014, p. 7). (9) Commission Delegated Regulation (EU) 2015/98 of 18 November 2014 on the implementation of the Union's international obligations, as referred to in Article 15(2) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council, under the International Convention for the Conservation of Atlantic Tunas and the Convention on Future Multilateral Cooperation in the Northwest Atlantic Fisheries (OJ L 16, 23.1.2015, p. 23). (10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (11) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (12) Commission Implementing Regulation (EU) No 404/2011 of 8 April 2011 laying down detailed rules for the implementation of Council Regulation (EC) No 1224/2009 establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy (OJ L 112, 30.4.2011, p. 1). (13) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (14) Commission Implementing Decision 2014/156/EU of 19 March 2014 establishing a specific control and inspection programme for fisheries exploiting stocks of bluefin tuna in the Eastern Atlantic and the Mediterranean, swordfish in the Mediterranean and for fisheries exploiting stocks of sardine and anchovy in the Northern Adriatic Sea (OJ L 85, 21.3.2014, p. 15). (15) Report of the Inter-sessional meeting of the Compliance Committee (Madrid, Spain, 24 to 26 February 2010), point 5 and Appendix 3 to Annex 4.2. (16) Commission Regulation (EC) No 26/2004 of 30 December 2003 on the Community fishing fleet register (OJ L 5, 9.1.2004, p. 25). (17) Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263, 3.10.2001, p. 1). (18) Regulation (EU) No 640/2010 of the European Parliament and of the Council of 7 July 2010 establishing a catch documentation programme for bluefin tuna Thunnus thynnus and amending Council Regulation (EC) No 1984/2003 (OJ L 194, 24.7.2010, p. 1). (19) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, p. 1). (20) Regulation (EU) No 508/2014 of the European Parliament and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council (OJ L 149, 20.5.2014, p. 1). ANNEX I Specific conditions applicable to the fisheries referred to in Article 14(2) 1. In addition to the provisions set out in Article 9(3), the maximum number of baitboats and trolling boats authorised to fish for bluefin tuna in the eastern Atlantic under the specific conditions applying to the derogation referred to in point (a) of Article 14(2) is set at the number of Union catching vessels participating in the directed fishery for bluefin tuna in 2006. 2 In addition to the provisions set out in Article 9(3), the maximum number of catching vessels authorised to fish for bluefin tuna in the Adriatic sea for farming purposes under the specific conditions applying to the derogation referred to in point (b) of Article 14(2) is set at the number of Union catching vessels participating in the directed fishery for bluefin tuna in 2008. For that purpose, the number of Croatian catching vessels participating in the directed fishery for bluefin tuna in 2008 shall be taken into account. 3. In addition to the provisions set out in Article 9(3), the maximum number of baitboats, longliners and handliners authorised to fish for bluefin tuna in the Mediterranean under the specific conditions applying to the derogation referred to in point (c) of Article 14(2) is set at the number of Union catching vessels participating in the directed fishery for bluefin tuna in 2008. 4. The maximum number of catching vessels determined in accordance with points 1, 2 and 3 of this Annex shall be allocated among the Member States in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 5. No more than 7 % of the Union quota for bluefin tuna between 8 kg or 75 cm and 30 kg or 115 cm shall be allocated among the authorised catching vessels referred to in point (a) of Article 14(2) and in point 1 of this Annex. That quota shall be allocated among Member States in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 6. By way of derogation from point (a) of Article 14(2), within the quota of 7 % referred to in point 5 of this Annex, up to 100 tonnes may be allocated for the capture of bluefin tuna of no less than 6,4 kg or 70 cm by baitboats of less than 17 metres. 7. The maximum allocation of the Union quota among Member States to fish under the specific conditions applying to the derogation referred to in point (b) of Article 14(2) and point 2 of this Annex shall be determined in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 8. No more than 2 % of the Union quota for bluefin tuna between 8 kg or 75 cm and 30 kg or 115 cm shall be allocated among the authorised catching vessels referred to in point (c) of Article 14(2) and point 3 of this Annex. That quota shall be allocated among Member States in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 9. Each Member State whose baitboats, longliners, handliners and trolling boats are authorised to fish for bluefin tuna in accordance with Article 14(2) and this Annex shall establish the following tail tag requirements: (a) tail tags are affixed on each bluefin tuna immediately upon offloading; (b) each tail tag has a unique identification number which is included in bluefin tuna statistical documents and written on the outside of any package containing tuna. ANNEX II Logbook requirements A. CATCHING VESSELS Minimum specifications for fishing logbooks: 1. The logbook shall be numbered by sheet. 2. The logbook shall be completed every day (midnight) or before port arrival. 3. The logbook shall be completed in case of at-sea inspections. 4. One copy of the sheets shall remain attached to the logbook. 5. Logbooks shall be kept on board to cover a period of one year of operation. Minimum standard information for fishing logbooks: 1. Master's name and address. 2. Dates and ports of departure, dates and ports of arrival. 3. Vessel's name, register number, ICCAT number, international radio call sign and IMO number (if available). 4. Fishing gear: (a) type FAO code; (b) dimension (e.g. length, mesh size, number of hooks). 5. Operations at sea with one line (minimum) per day of trip, providing: (a) activity (e.g. fishing, steaming); (b) position: exact daily positions (in degree and minutes), recorded for each fishing operation or at midday when no fishing has been conducted during that day; (c) record of catches, including: (1) FAO code; (2) round (RWT) weight in kg per day; (3) number of pieces per day. For purse seiners that should be recorded by fishing operation, including nil return. 6. Master's signature. 7. Means of weight measure: estimation, weighing on board. 8. The logbook shall be kept in equivalent live weight of fish and shall mention the conversion factors used in the evaluation. Minimum information for fishing logbooks in case of landing or transhipment: 1. Dates and port of landing/transhipment. 2. Products: (a) species and presentation by FAO code; (b) number of fish or boxes and quantity in kg. 3. Signature of the master or vessel agent. 4. In case of transhipment: receiving vessel name, its flag and ICCAT number. Minimum information for fishing logbooks in case of transfer into cages: 1. Date, time and position (latitude/longitude) of transfer. 2. Products: (a) species identification by FAO code; (b) number of fish and quantity in kg transferred into cages. 3. Name of towing vessel, its flag and ICCAT number. 4. Name of the farm of destination and its ICCAT number. 5. In the case of a JFO, in addition to the information laid down in points 1 to 4, the masters shall record in their logbook: (a) as regards the catching vessel transferring the fish into cages: \u2014 amount of catches taken on board, \u2014 amount of catches counted against its individual quota, \u2014 the names of the other vessels involved in the JFO; (b) as regards the other catching vessels of the same JFO not involved in the transfer of the fish: \u2014 the name of those vessels, their international radio call signs and ICCAT numbers, \u2014 that no catches have been taken on board or transferred into cages, \u2014 amount of catches counted against their individual quotas, \u2014 the name and the ICCAT number of the catching vessel referred to in point (a). B. TOWING VESSELS 1. The master of a towing vessel shall record in the daily logbook the date, time and position of transfer, the quantities transferred (number of fish and quantity in kg), the cage number, as well as the catching vessel's name, flag and ICCAT number, the name of the other vessel(s) involved and their ICCAT number, the farm of destination and its ICCAT number, and the ICCAT transfer declaration number. 2. Further transfers to auxiliary vessels or to other towing vessel shall be reported, including the same information as in point 1, as well as the auxiliary or towing vessel's name, flag and ICCAT number and the ICCAT transfer declaration number. 3. The daily logbook shall contain the details of all transfers carried out during the fishing season. The daily logbook shall be kept on board and be accessible at any time for control purposes. C. AUXILIARY VESSELS 1. The master of an auxiliary vessel shall record the activities daily in the logbook, including the date, time and positions, the quantities of bluefin tuna taken on board, and the fishing vessel, farm or trap name he/she is operating in association with. 2. The daily logbook shall contain the details of all activities carried out during the fishing season. The daily logbook shall be kept on board and be accessible at any time for control purposes. D. PROCESSING VESSELS 1. The master of a processing vessel shall report in the daily logbook the date, time and position of the activities and the quantities transhipped and the number and weight of bluefin tuna received from farms, traps or catching vessels, where applicable. The master should also report the names and ICCAT numbers of those farms, traps or catching vessels. 2. The master of a processing vessel shall maintain a daily processing logbook specifying the round weight and number of fish transferred or transhipped, the conversion factor used, and the weights and quantities by product presentation. 3. The master of a processing vessel shall maintain a stowage plan that shows the location and the quantities of each species and presentation. 4. The daily logbook shall contain the details of all transhipments carried out during the fishing season. The daily logbook, processing logbook, stowage plan and the originals of ICCAT transhipment declarations shall be kept on board and be accessible at any time for control purposes. ANNEX III ICCAT Transhipment Declaration Text of image Document No Carrier vessel Name of vessel and radio call sign: Flag: Flag State authorisation No National Register No ICCAT Register No IMO No Fishing Vessel Name of the vessel and radio call sign: Flag: Flag State authorisation No. National Register No. ICCAT Register No. External identification: Fishing logbook sheet No Final destination: Port: Country: State: Day Month Hour Year |2_|0_||| F.V Master\u2019s name: Carrier vessel Master\u2019s name: Departure ||| ||| ||| From: || Return ||| ||| ||| To: || Signature: Signature: Tranship. ||| ||| ||| || For transhipment, indicate the weight in kilograms or the unit used (e.g. box, basket) and the landed weight in kilograms of this unit: || kilograms. Text of image LOCATION OF TRANSHIPMENT Port Sea Species Number of unit of fish Type of product live Type of product whole Type of product gutted Type of product head off Type of product filleted Type of product Further transhipments Date: || Place/Position: || Authorisation CP No Transfer vessel Master\u2019s signature: Name of receiver vessel: Flag ICCAT Register No IMO No Master\u2019s signature Date: || Place/Position: || Authorisation CP No Transfer vessel Master\u2019s signature: Name of receiver vessel: Flag ICCAT Register No IMO No Master\u2019s signature Lat. Long. Obligations in case of transhipment: 1. The original of the transhipment declaration shall be provided to the recipient vessel (processing/transport). 2. The copy of the transhipment declaration shall be kept by the correspondent catching vessel or trap. 3. Further transhipping operations shall be authorised by the relevant CPC which authorised the vessel to operate. 4. The original of the transhipment declaration has to be kept by the recipient vessel which holds the fish, up to the landing place. 5. The transhipping operation shall be recorded in the logbook of any vessel involved in the operation. ANNEX IV Text of image Document No ICCAT Transfer Declaration 1. TRANSFER OF LIVE BFT DESTINATED FOR FARMING Fishing vessel name: Call sign: Flag: Flag State transfer authorisation No ICCAT Register No External identification: Fishing logbook No JFO No Trap name: ICCAT Register No Tug vessel name: Call sign: Flag: ICCAT Register No: External identification: Name of destination farm: ICCAT Register No: Cage number: 2. TRANSFER INFORMATION Date: _ _ / _ _ / _ _ _ _ Place or position: Port: Lat: Long: Number of individuals: Species: Weight: Type of product: Live Whole Gutted Other (Specify): Master of fishing vessel trap operator/farm operator name and signature: Master of receiver vessel (tug, processing, carrier) name and signature: Observer names, ICCAT No and signature: 3. FURTHER TRANSFERS Date: _ _ / _ _ / _ _ _ _ Place or position: Port: Lat: Long: Tug vessel name: Call sign: Flag: ICCAT Register No Farm state transfer authorisation No: External identification: Master of receiver vessel name and signature: Text of image Date: _ _ / _ _ / _ _ _ _ Place or position: Port: Lat: Long: Tug vessel name: Call sign: Flag: ICCAT Register No Farm state transfer authorisation no: External identification: Master of receiver vessel name and signature: Date: _ _ / _ _ / _ _ _ _ Place or position: Port: Lat: Long: Tug vessel name: Call sign: Flag: ICCAT Register No Farm state transfer authorisation No: External identification: Master of receiver vessel name and signature: 4. SPLIT CAGES Donor cage No Kg: No of fish: Donor tug vessel name: Call sign: Flag: ICCAT Register No Receiving cage No Kg: No of fish: Receiving tug vessel name: Call sign: Flag: ICCAT Register No Receiving cage No Kg: No of fish: Receiving tug vessel name: Call sign: Flag: ICCAT Register No Receiving cage No Kg: No of fish: Receiving tug vessel name: Call sign: Flag: ICCAT Register No ANNEX V Catch report form Flag ICCAT Number Vessel name Report start date Report end date Report duration (d) Catch date Location of the catch Catch Attributed weight in case of a joint fishing operation (kg) Latitude Longitude Weight (kg) Number of pieces Average weight (kg) ANNEX VI Joint fishing operation Flag State Vessel name ICCAT No Duration of the operation Identity of the operators Vessel's individual quota Allocation key per vessel Fattening and farming farm destination CPC ICCAT No Date \u2026 Validation of the flag State \u2026 ANNEX VII ICCAT regional observer programme ASSIGNMENT OF ICCAT REGIONAL OBSERVERS 1. Each ICCAT regional observer shall have the following qualifications to accomplish their tasks: (a) sufficient experience to identify species and fishing gear; (b) satisfactory knowledge of the ICCAT conservation and management measures assessed by a certificate provided by the Member States and based on ICCAT training guidelines; (c) the ability to observe and record accurately; (d) a satisfactory knowledge of the language of the flag of the vessel or farm observed. OBLIGATIONS OF THE ICCAT REGIONAL OBSERVER 2. The ICCAT regional observers shall: (a) have completed the technical training required by the guidelines established by ICCAT; (b) be nationals of one of the Member States and, to the extent possible, not of the farm or trap state or the flag State of the purse seiner. If, however, bluefin tuna is harvested from the cage and traded as fresh products, the ICCAT regional observer that observes the harvest may be a national of the Member State responsible for the farm; (c) be capable of performing the tasks set out in point 3; (d) be included in the list of ICCAT regional observers maintained by ICCAT; (e) not have current financial or beneficial interests in the bluefin tuna fishery. ICCAT REGIONAL OBSERVER TASKS 3. The tasks of ICCAT regional observers shall be, in particular: (a) as regards observers on purse seine vessels, to monitor the purse seine vessels' compliance with the relevant conservation and management measures adopted by ICCAT. In particular, the regional observer shall: (1) in cases where the ICCAT regional observer observes what may constitute non-compliance with ICCAT recommendations, he/she shall submit that information without delay to the ICCAT regional observer implementing company who shall forward it without delay to the flag State authorities of the catching vessel; (2) record and report upon the fishing activities carried out; (3) observe and estimate catches and verify entries made in the logbook; (4) issue a daily report of the purse seine vessels' transfer activities; (5) sight and record vessels which may be fishing in contravention of ICCAT conservation and management measures; (6) record and report upon the transfer activities carried out; (7) verify the position of the vessel when engaged in transfer; (8) observe and estimate products transferred, including through the review of video recordings; (9) verify and record the name of the fishing vessel concerned and its ICCAT number; (10) carry out scientific work such as collecting Task II data when required by the ICCAT Commission, based on the directives from the SCRS; (b) as regards ICCAT regional observers in farms and traps, to monitor their compliance with the relevant conservation and management measures adopted by ICCAT. In particular, the ICCAT regional observer shall: (1) verify the data contained in the transfer declaration and caging declaration and BCD, including through the review of video records; (2) certify the data contained in the transfer declaration and caging declaration and BCDs; (3) issue a daily report of the farms' and traps' transfer activities; (4) countersign the transfer declaration and caging declaration and BCDs only when he/she agrees that the information contained within them is consistent with his/her observations including a compliant video record as per the requirements referred to in Article 35(1) and Article 44(1); (5) carry out such scientific work, for example collecting samples, as required by the Commission, based on the directives from the SCRS; (6) register and verify the presence of any type of tag, including natural marks, and notify any sign of recent tag removals; (c) establish general reports compiling the information collected in accordance with this point and provide the master and farm operator with the opportunity to include therein any relevant information; (d) submit to the Secretariat the general report referred to in point (c) within 20 days from the end of the period of observation; (e) exercise any other functions as defined by the ICCAT Commission. 4. The ICCAT regional observer shall treat as confidential all information with respect to the fishing and transfer operations of the purse seiners and of the farms and shall accept that requirement in writing as a condition of appointment as an ICCAT regional observer. 5. The ICCAT regional observer shall comply with requirements established in the laws and regulations of the flag or farm state which exercises jurisdiction over the vessel or farm to which the ICCAT regional observer is assigned. 6. The ICCAT regional observer shall respect the hierarchy and general rules of behaviour which apply to all vessel and farm personnel, provided such rules do not interfere with the duties of the ICCAT regional observer under this programme, and with the obligations of vessel and farm personnel set out in point 7 of this Annex and Article 51(6). OBLIGATIONS OF THE FLAG MEMBER STATES TOWARDS ICCAT REGIONAL OBSERVERS 7. Member States responsible for the purse seiner, farm or trap, shall ensure that ICCAT regional observers are: (a) allowed access to the vessel, farm and trap personnel and to the gear, cages and equipment; (b) allowed access, upon request, to the following equipment, if present on the vessels to which they are assigned, in order to facilitate the carrying out of their duties set out in point 3 of this Annex: (1) satellite navigation equipment, (2) radar display viewing screens when in use, (3) electronic means of communication; (c) provided with accommodation, including lodging, food and adequate sanitary facilities, equal to those of officers; (d) provided with adequate space on the bridge or pilot house for clerical work, as well as space on deck adequate for carrying out observer duties. COSTS ARISING FROM THE ICCAT REGIONAL OBSERVER PROGRAMME 8. All costs arising from the operation of ICCAT regional observers shall be borne by each farm operator or owner of purse seiners. ANNEX VIII ICCAT scheme of joint international inspection ICCAT agreed at its Fourth Regular Meeting (Madrid, November 1975) and at its Annual Meeting in 2008 in Marrakesh that: Pursuant to paragraph 3 of Article IX of the Convention, the ICCAT Commission recommends the establishment of the following arrangements for international control outside the waters under national jurisdiction for the purpose of ensuring the application of the Convention and the measures in force thereunder: I. SERIOUS VIOLATIONS 1. For the purposes of these procedures, a serious violation means the following violations of the provisions of the ICCAT conservation and management measures adopted by the ICCAT Commission: (a) fishing without a licence, permit or authorisation issued by the flag CPC; (b) failure to maintain sufficient records of catch and catch-related data in accordance with the ICCAT Commission's reporting requirements or significant misreporting of such catch and/or catch-related data; (c) fishing in a closed area; (d) fishing during a closed season; (e) intentional taking or retention of species in contravention of any applicable conservation and management measure adopted by ICCAT; (f) significant violation of catch limits or quotas in force pursuant to ICCAT rules; (g) using prohibited fishing gear; (h) falsifying or intentionally concealing the markings, identity or registration of a fishing vessel; (i) concealing, tampering with or disposing of evidence relating to the investigation of a violation; (j) multiple violations which, taken together, constitute a serious disregard of measures in force pursuant to ICCAT; (k) assault, resist, intimidate, sexually harass, interfere with, or unduly obstruct or delay an authorised inspector or observer; (l) intentionally tampering with or disabling the VMS; (m) such other violations as may be determined by the ICCAT, once those are included and circulated in a revised version of those procedures; (n) fishing with the assistance of spotter planes; (o) interference with the satellite monitoring system and/or operation of a vessel without the VMS; (p) transfer activity without transfer declaration; (q) transhipment at sea. 2. In the case of any boarding and inspection of a fishing vessel during which the authorised inspector observes an activity or condition that would constitute a serious violation, as defined in point 1, the authorities of the flag State of the inspection vessels shall immediately notify the flag State of the fishing vessel, directly as well as through the ICCAT Secretariat. In such situations, the inspector shall also inform any inspection ship of the flag State of the fishing vessel known to be in the vicinity. 3. The ICCAT inspector shall register, in the fishing vessel's logbook, the inspections undertaken and any infringements detected. 4. The flag Member State shall ensure that, following the inspection referred to in point 2, the fishing vessel concerned ceases all fishing activities. The flag Member State shall require the fishing vessel to proceed within 72 hours to a port designated by it, where an investigation shall be initiated. 5. If the vessel is not called to port, the flag Member State shall provide due justification in a timely manner to the European Commission which shall forward the information to the ICCAT Secretariat, who shall make it available on request to other Contracting Parties. II. CONDUCT OF INSPECTIONS 6. Inspections shall be carried out by inspectors designated by the Contracting Parties. The names of the authorised government agencies and each inspector designated for that purpose by their respective governments shall be notified to the ICCAT Commission. 7. Ships carrying out international boarding and inspection duties in accordance with this Annex shall fly a special flag or pennant approved by the ICCAT Commission and issued by the ICCAT Secretariat. The names of the ships so used shall be notified to the ICCAT Secretariat as soon as practical in advance of the commencement of inspection activities. The ICCAT Secretariat shall make information regarding designated inspection vessels available to all CPCs, including by posting on its password-protected website. 8. Each inspector shall carry an appropriate identity document issued by the authorities of the flag State, which shall be in the form shown in point 21 of this Annex. 9. Subject to the arrangements agreed under point 16, a vessel flagged to a Contracting Party and fishing for tuna or tuna-like fish in the Convention area outside the waters within its national jurisdiction shall stop when given the appropriate signal in the International Code of Signals by a ship flying the ICCAT pennant described in point 7 and carrying an inspector, unless the vessel is actually carrying out fishing operations, in which case it shall stop immediately once it has finished such operations. The master of the vessel shall permit the inspection party, as specified in point 10, to board it and shall provide a boarding ladder. The master shall enable the inspection party to make such examination of equipment, catch or gear and any relevant documents as an inspector deems necessary to verify the compliance with the ICCAT Commission's recommendations in force in relation to the flag State of the vessel being inspected. Further, an inspector may ask for any explanations that are deemed necessary. 10. The size of the inspection party shall be determined by the commanding officer of the inspection vessel, taking into account relevant circumstances. The inspection party shall be as small as possible to safely and securely accomplish the duties set out in this Annex. 11. Upon boarding the vessel, the inspector shall produce the identity documentation described in point 8. The inspector shall observe generally accepted international regulations, procedures and practices relating to the safety of the vessel being inspected and its crew, and shall minimise interference with fishing activities or stowage of product and, to the extent practicable, avoid action which would adversely affect the quality of the catch on board. Each inspector shall limit his/her enquiries to the ascertainment of the observance of the ICCAT Commission's recommendations in force in relation to the flag State of the vessel concerned. In making the inspection, an inspector may ask the master of the fishing vessel for any assistance that may be required. The inspector shall draw up a report of the inspection in a form approved by the ICCAT Commission. The inspector shall sign the report in the presence of the master of the vessel who shall be entitled to add or have added to the report any observations which he/she may think suitable and shall sign such observations. 12. Copies of the report shall be given to the master of the vessel and to the government of the inspection party, which shall transmit copies to the appropriate authorities of the flag State of the inspected vessel and to the ICCAT Commission. Where any infringement of ICCAT recommendations is discovered, the inspector shall, where possible, also inform any inspection ship of the flag State of the fishing vessel known to be in the vicinity. 13. Resistance to an inspector or failure to comply with his/her directions shall be treated by the flag State of the inspected vessel in a manner similar to such conduct committed with respect to a national inspector. 14. The inspector shall carry out his/her duties under these arrangements in accordance with the rules set out in this Regulation, but they shall remain under the operational control of their national authorities and shall be responsible to them. 15. Contracting Parties shall consider and act on inspection reports, sighting information sheets as per Recommendation 94-09 and statements resulting from documentary inspections of foreign inspectors under these arrangements on a similar basis in accordance with their national legislation to the reports of national inspectors. The provisions of this point shall not impose any obligation on a Contracting Party to give the report of a foreign inspector a higher evidential value than it would possess in the inspector's own country. Contracting Parties shall collaborate in order to facilitate judicial or other proceedings arising from a report of an inspector under these arrangements. 16. (a) Contracting Parties shall inform the ICCAT Commission by 15 February each year of their provisional plans for conducting inspection activities under this Regulation in that calendar year and the ICCAT Commission may make suggestions to Contracting Parties for the coordination of national operations in this field, including the number of inspectors and ships carrying inspectors. (b) The arrangements set out in this Regulation and the plans for participation shall apply between Contracting Parties unless otherwise agreed between them, and such agreement shall be notified to the ICCAT Commission. However, the implementation of the scheme shall be suspended between any two Contracting Parties if either of them has notified the ICCAT Commission to that effect, pending completion of such an agreement. 17. (a) The fishing gear shall be inspected in accordance with the regulations in force for the subarea in which the inspection takes place. The inspector shall state the subarea for which the inspection took place, and a description of any violations found in the inspection report. (b) The inspector shall be entitled to inspect all fishing gear in use or on board. 18. The inspector shall affix an identification mark approved by the ICCAT Commission to any fishing gear inspected which appears to be in contravention of the ICCAT Commission recommendations in force in relation to the flag State of the vessel concerned and shall record this fact in the inspection report. 19. The inspector may photograph the gear, equipment, documentation and any other element he/she consider necessary in such a way as to reveal those features which in his/her opinion are not in conformity with the regulation in force, in which case the subjects photographed shall be listed in the report and copies of the photographs shall be attached to the copy of the report to the flag State. 20. The inspector shall, as necessary, inspect all catch on board to determine compliance with ICCAT recommendations. 21. The model identity card for inspectors is as follows: ANNEX IX Minimum standards for video recording procedures Transfer operations 1. The electronic storage device containing the original video record shall be provided to the ICCAT regional observer as soon as possible after the end of the transfer operation, who shall immediately initialise it to avoid any further manipulation. 2. The original recording shall be kept on board the catching vessel or by the farm or trap operator, where appropriate, during its entire period of authorisation. 3. Two identical copies of the video record shall be produced. One copy shall be transmitted to the ICCAT regional observer on board the purse seiner and one to the national observer on board the towing vessel, the latter of which shall accompany the transfer declaration and the associated catches to which it relates. That procedure shall only apply to national observers in the case of transfers between towing vessels. 4. At the beginning and/or the end of each video, the ICCAT transfer authorisation number shall be displayed. 5. The time and the date of the video shall be continuously displayed throughout each video record. 6. Before the start of the transfer, the video shall include the opening and closing of the net/door and footage showing whether the receiving and donor cages already contain bluefin tuna. 7. The video recording shall be continuous without any interruptions and cuts and cover the entire transfer operation. 8. The video record shall be of sufficient quality to estimate the number of bluefin tuna being transferred. 9. If the video record is of insufficient quality to estimate the number of bluefin tuna being transferred, then a new transfer shall be requested by the control authorities. The new transfer shall include all the bluefin tuna in the receiving cage into another cage which must be empty. Caging operations 1. The electronic storage device containing the original video record shall be provided to the ICCAT regional observer as soon as possible after the end of the caging operation, who shall immediately initialise it to avoid any further manipulation. 2. The original recording shall be kept by the farm, where applicable, during their entire period of authorisation. 3. Two identical copies of the video record shall be produced. One copy shall be transmitted to the ICCAT regional observer deployed on the farm. 4. At the beginning and/or the end of each video, the ICCAT caging authorisation number shall be displayed. 5. The time and the date of the video shall be continuously displayed throughout each video record. 6. Before the start of the caging, the video shall include the opening and closing of the net/door and whether the receiving and donor cages already contain bluefin tuna. 7. The video recording shall be continuous without any interruptions and cuts and cover the entire caging operation. 8. The video record shall be of sufficient quality to estimate the number of bluefin tuna being transferred. 9. If the video record is of insufficient quality to estimate the number of bluefin tuna being transferred, then a new caging operation shall be requested by the control authorities. The new caging operation shall include all the bluefin tuna in the receiving farm cage into another farm cage which shall be empty. ANNEX X Standards and procedures for the programmes and reporting obligations referred to in Article 46(2) to (7) and Article 47(1) A. Use of stereoscopical cameras systems The use of stereoscopic cameras systems in the context of caging operations, as required by Article 46 of this Regulation, shall be conducted in accordance with the following: 1. The sampling intensity of live fish shall not be below 20 % of the amount of fish being caged. When technically possible, the sampling of live fish shall be sequential, one in every five specimens being measured; such a sample shall be made up of fish measured at a distance between 2 and 8 metres from the camera. 2. The dimensions of the transfer gate connecting the donor cage and the receiving cage shall be set at a maximum width of 10 metres and a maximum height of 10 metres. 3. When the length measurements of the fish present a multi-modal distribution (two or more cohorts of distinct sizes), it shall be possible to use more than one conversion algorithm for the same caging operation; the most up-to-date algorithm(s) established by SCRS shall be used to convert fork lengths into total weights, according to the size category of the fish measured during the caging operation. 4. Validation of the stereoscopical length measurements shall be undertaken prior to each caging operation using a scale bar at a distance of between 2 and 8 metres. 5. When the results of the stereoscopical programme are communicated, the information shall indicate the margin of error inherent to the technical specifications of the stereoscopic camera system, which shall not exceed a range of +/\u2013 5 %. 6. The report on the results of the stereoscopical programme shall include details on all the technical specifications above, including the sampling intensity, the way of sampling methodology, the distance from the camera, the dimensions of the transfer gate, and the algorithms (length-weight relationship). SCRS shall review those specifications and, if necessary, provide recommendations to modify them. 7. In cases where the stereoscopic camera footage is of insufficient quality to estimate the weight of bluefin tuna being caged, a new caging operation shall be ordered by the Member State authorities responsible for the catching vessel, trap or farm. B. Presentation and use of the results of the programmes 1. Decisions regarding differences between the catch report and the results from the stereoscopical system programme shall be taken at the level of the JFO or total trap catches, for JFOs and trap catches destined to a farm facility involving a single CPC and/or Member State. The decision regarding differences between the catch report and the results from the stereoscopical system programme shall be taken at the level of the caging operations for JFOs involving more than one CPC and/or Member State, unless otherwise agreed by all the flag CPC and/or Member State authorities of the catching vessels involved in the JFO. 2. The Member State responsible for the farm shall provide a report to the Member State or CPC responsible for the catching vessel or trap and to the Commission, including the following documents: (a) technical stereoscopical system report including: \u2014 general information: species, site, cage, date, algorithm, \u2014 sizing statistical information: average weight and length, minimum weight and length, maximum weight and length, number of fish sampled, weight distribution, size distribution; (b) detailed results of the programme, with the size and weight of every fish that was sampled; (c) caging report including: \u2014 general information on the operation: number of the caging operation, name of the farm, cage number, BCD number, ITD number, name and flag of the catching vessel or trap, name and flag of the towing vessel, date of the stereoscopical system operation and footage file name, \u2014 algorithm used to convert length into weight, \u2014 comparison between the amounts declared in the BCD and the amounts found with the stereoscopical system, in number of fish, average weight and total weight (the formula used to calculate the difference shall be: (stereoscopical system-BCD)/stereoscopical system * 100), \u2014 margin of error of the system, \u2014 for those caging reports relating to JFOs/traps, the last caging report shall also include a summary of all information in previous caging reports. 3. When receiving the caging report, the Member State authorities of the catching vessel or trap shall take all the necessary measures according to the following situations: (a) the total weight declared by the catching vessel or trap in the BCD is within the range of the stereoscopical system results: \u2014 no release shall be ordered, \u2014 the BCD shall be modified both in number (using the number of fish resulting from the use of the control cameras or alternative techniques) and average weight, while the total weight shall not be modified; (b) the total weight declared by the catching vessel or trap in the BCD is below the lowest figure of the range of the stereoscopical system results: \u2014 a release shall be ordered using the lowest figure in the range of the stereoscopical system results, \u2014 the release operations shall be carried out in accordance with the procedure laid down in Article 34(2) and Annex XI, \u2014 after the release operations took place, the BCD shall be modified both in number (using the number of fish resulting from the use of the control cameras, minus the number of fish released) and average weight, while the total weight shall not be modified; (c) the total weight declared by the catching vessel or trap in the BCD exceeds the highest figure of the range of the stereoscopical system results: \u2014 no release shall be ordered, \u2014 the BCD shall be modified for the total weight (using the highest figure in the range of the stereoscopical system results), for the number of fish (using the results from the control cameras) and average weight accordingly. 4. For any relevant modification of the BCD, the values (number and weight) entered in Section 2 shall be consistent with those in Section 6 and the values in Sections 3, 4 and 6, shall be not higher those in Section 2. 5. In case of compensation of differences found in individual caging reports across all cagings from a JFO/trap, whether or not a release operation is required, all relevant BCDs shall be modified on the basis of the lowest range of the stereoscopical system results. The BCDs related to the quantities of bluefin tuna released shall also be modified to reflect the weight/number released. The BCDs related to bluefin tuna not released but for which the results from the stereoscopical systems or alternative techniques differ from those reported caught and transferred shall also be amended to reflect those differences. The BCDs relating to the catches from where the release operation took place shall also be modified to reflect the weight/number released. ANNEX XI Release protocol 1. The release of bluefin tuna from farming cages into the sea shall be recorded by video camera and observed by an ICCAT regional observer, who shall draft and submit a report together with the video records to the ICCAT Secretariat. 2. When a release order has been issued, the farm operator shall request the deployment of an ICCAT regional observer. 3. The release of bluefin tuna from transport cages or traps into the sea shall be observed by a national observer of the Member State responsible for the towing vessel or trap, who shall draft and submit a report to the responsible Member State control authorities. 4. Before a release operation takes place, Member State control authorities might order a control transfer using standard and/or stereoscopic cameras to estimate the number and weight of the fish that need to be released. 5. Member State authorities may implement any additional measures they consider necessary to guarantee that the release operations take place at the most appropriate time and place in order to increase the probability of the fish going back to the stock. The operator shall be responsible for the fish survival until the release operation has taken place. Those release operations shall take place within three weeks of the completion of the caging operations. 6. Following completion of harvesting operations, fish remaining in a farm and not covered by the BCD shall be released in accordance with the procedures laid down in Article 34(2) and this Annex. ANNEX XII Treatment of dead fish During fishing operations by purse seiners, the quantities of fish found dead in the seine shall be recorded in the fishing vessel logbook and shall be deducted from the Member State quota accordingly. Recording/treating of dead fish during the first transfer (1) The BCD shall be provided to the operator of the towing vessel with Section 2 (Total catch), Section 3 (Live fish trade) and Section 4 (Transfer \u2014 including \u2018dead\u2019 fish) completed. The total quantities reported in Sections 3 and 4 shall be equal to the quantities reported in Section 2. The BCD shall be accompanied by the original ICCAT Transfer Declaration (ITD) in accordance with the provisions of this Regulation. The quantities reported in the ITD (transferred live), shall be equal to the quantities reported in Section 3 in the associated BCD. (2) A split of the BCD with Section 8 (Trade information) shall be completed and given to the operator of the auxiliary vessel which transports the dead bluefin tuna to shore (or retained on the catching vessel if landed directly to shore). The dead fish and split BCD shall be accompanied by a copy of the ITD. (3) The quantities of dead fish shall be recorded in the BCD of the catching vessel which made the catch or, in the case of JFOs, in the BCD of the catching vessels or of a vessel flying another flag participating in the JFO. ANNEX XIII Correlation table Regulation (EC) No 302/2009 This Regulation Article 1 Articles 1 and 2 Article 2 Article 3 Article 3 Article 4 Article 4(1) Article 5(1) Article 4(2) Article 6(1)(a) Article 4(3) and (5) Article 7 Article 4(4), second subparagraph Article 6(1)(a) and (2) Article 4(6)(a),(b) and second subparagraph Article 54 Article 4(6), third subparagraph Article 20(2) Article 4(7) to (12) \u2014 Article 4(13) Article 5(3) Article 4(15) Article 17 Article 5(1) Article 6(1)(b) Article 5(2) to (6) Article 9(1) to (6) Article 5(7),(8) and the first subparagraph of paragraph 9 \u2014 Article 5(9), second subparagraph Article 6(2) Article 6 Article 10 Article 7 Articles 11 and 12 Article 8 Article 17 Article 9(1) and (2) Article 14(1) and (2) Article 9(3),(4),(5) and (7) to (10) Annex I Article 9(6) \u2014 Article 9(11) Article 14(3) Article 9(12) to (15) Article 15 Article 10 \u2014 Article 11 Article 16(2),(3) and (5) Article 12(1) to (4) Article 19 Article 12(5) \u2014 Article 13(1),(2) and (3) Article 19 Article 13(4) \u2014 Article 14(1),(2),(3) and (5) Article 20 Article 14(4) Article 22(1) Article 15 Article 23 Article 16 Article 29(1),(3) and (4) Article 17 Article 30 Article 18(1) Article 25 Article 18(2) Annex II Article 19 Article 24(1),(2) and (3) Article 20(1) and (2) Article 26(1),(2) and (3) Article 20(3) and (4) Article 27 Article 21 Article 31(1) to (4) and (6) Article 22(1) and the first subparagraph of paragraph 2 Article 33(1),(3) and (5) Article 22(2), second subparagraph Article 34(1) Article 22(3) Article 34(2) Article 22(4) Article 38(1),(2) and (3) Article 22(5) Annex II Article 22(6) Article 33(6) Article 22(7) Article 35(1) and Annex IX Article 22(8) and the first subparagraph of paragraph 9 Article 36 Article 22(9), second subparagraph \u2014 Article 22(10) Article 39 Article 23 Article 32 Article 24(1) Article 47(1) Article 24(2),(4) and (6) Article 40(2) to (5) Article 24(3) Article 41(1) and (2) Article 24(5) Article 42 Article 24(7) Article 44(1) and Annex IX Article 24(8), first subparagraph Article 45(1) and (2) Article 24(9) \u2014 Article 24(10) Article 48 Article 24a Annex X Article 25 Article 49 Article 26(1) Article 26(4) Article 26(2) Article 27(1) Article 26(3) Article 26(5) Article 27(1) Article 31(5) Article 27(2) Article 41 Article 27(3) Article 3 point (24) Article 28 Article 55 Article 29 Article 52 Article 30 Article 50 Article 31(1) and (2)(a),(b),(c) and (h) Article 51 (2) to (6) Article 31(2)(d) to (g) Annex VII Article 31(3) and (4) Annex VII Article 32 Article 35(2),(3) and (4) Article 44(2),(3) and (4) Article 33 \u2014 Article 33a Article 53 Article 34 Article 56 Article 35 \u2014 Article 36 \u2014 Article 37 Article 57 Article 38 Article 58 Article 38a Article 59(1) and (2) Article 39 Article 60 Article 40 \u2014 Article 41 Article 61", "summary": "Multiannual recovery plan for bluefin tuna Multiannual recovery plan for bluefin tuna SUMMARY OF: Regulation (EU) 2016/1627 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean WHAT IS THE AIM OF THE REGULATION? It updates the rules of the European Union (EU) on applying the multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, which runs from 2007 to 2022, and is recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT), an intergovernmental fishery organisation to which the EU is a contracting party. It replaces and repeals Regulation (EC) No 302/2009. KEY POINTS The regulation\u2019s objective is to achieve a biomass* of bluefin tuna corresponding to the maximum sustainable yield by 2022 with at least a 60% probability of achieving that objective. Each EU Member State must: ensure that the fishing effort of its catching vessels and its traps are proportionate to the bluefin tuna fishing opportunities (total allowable catches allocated under Regulation (EU) No 1380/2013 \u2014 the EU\u2019s common fisheries policy) available to it in the eastern Atlantic and the Mediterranean; submit to the European Commission an annual fishing plan for its vessels and traps and annual fishing capacity and farming management plans that ensure its fishing capacity is in line with its allocated quota. The regulation contains rules on: minimum conservation reference sizes (generally, 30 kg or 115 cm fork length, although lower in certain fisheries); incidental catches (parts of catches which are not targeted) \u2014 up to maximum of 5% of bluefin tuna weighing between 8 and 30 kg or with a fork length between 75 and 115 cm; the use of (prohibited) aerial means, such as aircraft, to search for bluefin tuna; records of both fishing and non-catching vessels and traps \u2014 Member States have to supply these to the Commission each year; recording requirements \u2014 vessels must use logbooks to record information (Annex II, Part A); designated ports for landing or transhipping bluefin tuna \u2014 Member States must send a list of these ports to the Commission each year; caging operations, their authorisation and inspection; monitoring and surveillance \u2014 vessel monitoring, national observer programmes and the ICCAT regional observer programme; inspections and cross-checks \u2014 the ICCAT joint scheme of international inspection and Member States\u2019 inspection plans; marketing \u2014 trade, landing, import, export, pacing in cages for fattening or farming, re-export and transhipment of bluefin tuna are not permitted in the EU unless accompanied by accurate, complete and validated documentation, as set out in this regulation, Regulation (EU) No 640/2010 and Regulation (EC) No 1936/2001 (see summary); catches in the cases of sport or recreational fishing: no more than one bluefin tuna may be caught per vessel,any bluefin tuna landed must be whole, gilled and/or gutted,there are measures to be introduced in Member States to ensure the release of bluefin tuna, especially juveniles, caught alive in the course of sport and recreational fishing,the sale of bluefin tuna caught during sport and recreational fishing is banned. Amending Regulation (EU) 2019/833 Regulation (EU) 2019/833 amends Regulation (EU) 2016/1627, requiring Member States: to draw up an annual fishing capacity management plan to adjust the number of fishing vessels, in order to demonstrate that the fishing capacity is commensurate with the fishing opportunities allocated to the vessels in the relevant time period; with a bluefin tuna quota, to transmit to the Commission by 31 January each year an annual farming management plan which the Commission then compiles and integrates into the EU plan which must be forwarded to the ICCAT Secretariat by 15 February of each year for discussion and approval by ICCAT; in their annual farming management plan, to demonstrate that the total input capacity and the total farming capacity are commensurate with the estimated amount of bluefin tuna available for farming; to make provisions for by-catch of bluefin tuna within their quota and to inform the Commission thereof when transmitting their annual fishing plans. The amending regulation also sets new rules for fishing seasons for different types of vessels and on the level of by-catches of bluefin tuna (which must not exceed 20% of the total catches on board at the end of each fishing trip). The methodology used to calculate those by-catches, in relation to the total catch on board, must be clearly defined in Member States\u2019 annual fishing plans. FROM WHEN DOES THE REGULATION APPLY? It has applied since 6 October 2016. BACKGROUND For further information, see: Bluefin tuna: Council agrees on update of the multiannual recovery plan (Council of the European Union). KEY TERMS Biomass. The mass of tuna in a given body of water at a given time. MAIN DOCUMENT Regulation (EU) 2016/1627 of the European Parliament and of the Council of 14 September 2016 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, and repealing Council Regulation (EC) No 302/2009 (OJ L 252, 16.9.2016, pp. 1\u201352). Successive amendments to Regulation (EU) 2016/1627 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, pp. 22\u201361). See consolidated version. Regulation (EU) No 640/2010 of the European Parliament and of the Council of 7 July 2010 establishing a catch documentation programme for bluefin tuna Thunnus thynnus and amending Council Regulation (EC) No 1984/2003 (OJ L 194, 24.7.2010, pp. 1\u201322). Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263, 3.10.2001, pp. 1\u20138). See consolidated version. last update 29.10.2021"}
{"article": "30.6.2016 EN Official Journal of the European Union L 176/1 REGULATION (EU) 2016/1035 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2016 on protection against injurious pricing of vessels (codification) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Council Regulation (EC) No 385/96 (2) has been substantially amended (3). In the interests of clarity and rationality, that Regulation should be codified. (2) Multilateral negotiations conducted under the auspices of the Organisation for Economic Cooperation and Development led to the conclusion, on 21 December 1994, of an Agreement Respecting Normal Competitive Conditions in the Commercial Shipbuilding and Repair Industry (\u2018the Shipbuilding Agreement\u2019). (3) It has been recognised in the framework of the Shipbuilding Agreement that the special characteristics of ship-purchase transactions have made it impractical to apply countervailing and anti-dumping duties, as provided for under Article VI of the General Agreement on Tariffs and Trade, the Agreement on Subsidies and Countervailing Measures, and the Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 1994 (\u2018the 1994 Anti-Dumping Agreement\u2019) annexed to the Agreement establishing the World Trade Organisation. The need to provide for an effective means of protection against sales of ships below their normal value which cause injury has led to the conclusion of a Shipbuilding Injurious Pricing Code which, together with its Basic Principles, constitutes Annex III to the Shipbuilding Agreement (\u2018the IPI Code\u2019). (4) The text of the IPI Code is mainly based on the 1994 Anti-Dumping Agreement, but deviates from that Agreement when warranted by the specific nature of ship-purchase transactions. Therefore, the language of the IPI Code should be reflected in Union legislation, to the extent possible on the basis of the text of Regulation (EU) 2016/1036 of the European Parliament and of the Council (4). (5) The Shipbuilding Agreement and the legislative provisions deriving therefrom are of significant importance for Union law. (6) To maintain the balance of rights and obligations which the Shipbuilding Agreement establishes, action should be taken by the Union against any injuriously priced vessel whose sale at less than normal value causes injury to the Union industry. (7) As regards shipbuilders from Contracting Parties to the Shipbuilding Agreement, the sale of a vessel may be subject to an investigation by the Union only when the buyer of the vessel is a Union buyer, and provided the ship is not a military vessel. (8) It is desirable to set out clear and detailed rules on the calculation of the normal value. In particular, such value should, where possible, be based on a representative sale of a like vessel in the ordinary course of trade in the exporting country. It is expedient to define the circumstances in which a domestic sale may be considered to be made at a loss and may be disregarded, and in which recourse may be had to sale of a like vessel to a third country, or to constructed normal value. It is also desirable to provide for a proper allocation of costs, even in start-up situations. It is also necessary, when constructing the normal value, to indicate the methodology to be applied in determining the amounts for selling, general and administrative costs and the profit margin that should be included in such value. (9) In order to be able to apply correctly the instrument for combating injurious pricing, the Commission should take all necessary steps to ascertain, in the large conglomerates and holdings of third countries, the validity of accounting charges when the cost price structure needs to be estimated. (10) When determining the normal value for non-market economy countries, it appears prudent to set out rules for choosing the appropriate market-economy third country to be used for such purpose and, where it is not possible to find a suitable third country, to provide that the normal value may be established on any other reasonable basis. (11) It is expedient to define the export price and to enumerate the adjustments which should be made in those cases where a reconstruction of that price from the first open-market price is deemed necessary. (12) For the purpose of ensuring a fair comparison between the export price and the normal value, it is advisable to list the factors, including contractual penalties, which may affect prices and price comparability. (13) It is desirable to provide clear and detailed guidance as to the factors which may be relevant for the determination of whether the injuriously priced sale has caused material injury or is threatening to cause injury. In demonstrating that the price level of the sale concerned is responsible for injury sustained by the Union industry, attention should be given to the effect of other factors and, in particular, prevailing market conditions in the Union. (14) It is advisable to define the term \u2018Union industry\u2019 by reference to the capability to build a like vessel and to provide that parties related to exporters may be excluded from such an industry, and to define the term \u2018related\u2019. (15) It is necessary to set out the procedural and substantive conditions for lodging a complaint against injurious pricing, including the extent to which it should be supported by the Union industry, and the information on the buyer of the vessel, injurious pricing, injury and causation which such a complaint should contain. It is also expedient to specify the procedures for the rejection of complaints or the initiation of proceedings. (16) When the buyer of the injuriously priced vessel is established in the territory of another Contracting Party to the Shipbuilding Agreement, a complaint may also contain a request that an investigation be initiated by the authorities of that Contracting Party. Such request should be transmitted to the authorities of the Contracting Party, where warranted. (17) Where appropriate, an investigation may also be initiated upon a written complaint by the authorities of a Contracting Party to the Shipbuilding Agreement, in accordance with this Regulation and under the conditions of the Shipbuilding Agreement. (18) It is necessary to specify the manner in which interested parties should be given notice of the information which the authorities require. Interested parties should have ample opportunity to present all relevant evidence and to defend their interests. It is also desirable to set out clearly the rules and procedures to be followed during the investigation, in particular the rules whereby interested parties are to make themselves known, present their views and submit information within specified time limits, if such views and information are to be taken into account. It is also appropriate to set out the conditions under which an interested party may have access to, and comment on, information presented by other interested parties. There should also be cooperation between the Member States and the Commission in the collection of information. (19) It is necessary to provide that the termination of cases should, irrespective of whether an injurious pricing charge is imposed or not, take place no later than 1 year from the date of initiation or the date of delivery of the vessel, as the case may be. (20) Investigations or proceedings should be terminated where the margin of injurious pricing is de minimis. (21) The investigation may be terminated without the imposition of an injurious pricing charge if the sale of the injuriously priced vessel is definitively and unconditionally voided or if an alternative equivalent remedy is accepted. However, the need to avoid jeopardising achievement of the aim pursued under this Regulation should be given special consideration. (22) An injurious pricing charge equal to the amount of the injurious pricing margin should be imposed by decision on the shipbuilder whose injuriously priced sale of a vessel has caused injury to the Union industry, where all the conditions provided for in this Regulation are fulfilled. Precise and detailed rules should be laid down for the implementation of such decision, including all measures necessary for its actual enforcement, in particular the taking of countermeasures if the shipbuilder does not pay the injurious pricing charge within the applicable time limit. (23) It is necessary to set out precise rules for the denial of the right to load and unload in Union ports to vessels built by shipbuilders subject to countermeasures. (24) The obligation to pay the injurious pricing charge expires only when such charge is fully paid or at the end of the period during which the countermeasures are applicable. (25) Any action taken under this Regulation should not be contrary to the Union interest. (26) In acting pursuant to this Regulation, the Union should bear in mind the need for rapid and effective action. (27) It is expedient to provide for verification visits to check information submitted on injurious pricing and injury, such visits being, however, conditional on proper replies to questionnaires being received. (28) It is necessary to provide that, where parties do not cooperate satisfactorily, other information may be used to establish findings and that such information may be less favourable to the parties than if they had cooperated. (29) Provision should be made for the treatment of confidential information so that business secrets are not divulged. (30) It is essential that provision be made for the proper disclosure of the essential facts and considerations to parties which qualify for such treatment and that such disclosure be made, with due regard to the decision-making process in the Union, within a time period which permits parties to defend their interests. (31) The implementation of the procedures provided for in this Regulation requires uniform conditions for the adoption of measures necessary for its implementation in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (5), HAVE ADOPTED THIS REGULATION: Article 1 Principles and definitions 1. An injurious pricing charge may be imposed on the builder of any injuriously priced vessel whose sale to a buyer other than a buyer of the country in which the vessel originates causes injury. 2. A vessel is to be considered as being injuriously priced if the export price of the vessel sold is less than a comparable price for a like vessel, in the ordinary course of trade, when sold to a buyer of the exporting country. 3. For the purposes of this Regulation, the following definitions apply: (a) \u2018vessel\u2019 means any self-propelled sea-going vessel of 100 gross tonnes and above, used for transportation of goods or persons or for performance of a specialised service (for example, ice breakers and dredgers) and any tug of 365 kW and above; (b) \u2018like vessel\u2019 means any vessel of the same type, purpose and approximate size as the vessel under consideration and possessing characteristics closely resembling those of the vessel under consideration; (c) \u2018same general category of vessel\u2019 means any vessel of the same type and purpose, but of a significantly different size; (d) \u2018sale\u2019 covers the creation or transfer of an ownership interest in the vessel, except for an ownership interest created or acquired solely for the purpose of providing security for a normal commercial loan; (e) \u2018ownership interest\u2019 includes any contractual or proprietary interest which allows the beneficiary or beneficiaries of such interest to take advantage of the operation of the vessel in a manner substantially comparable to the way in which an owner may benefit from the operation of the vessel. In determining whether such substantial comparability exists, the following factors shall be considered, inter alia: (i) the terms and circumstances of the transaction; (ii) commercial practice within the industry; (iii) whether the vessel subject to the transaction is integrated into the operations of the beneficiary or beneficiaries; and (iv) whether in practice there is a likelihood that the beneficiary or beneficiaries of such interests will take advantage of, and the risk for, the operation of the vessel for a significant part of the life-time of the vessel; (f) \u2018buyer\u2019 means any person who, or any company which, acquires an ownership interest, including by way of lease or long-term bareboat charter, in conjunction with the original transfer from the shipbuilder, either directly or indirectly, including a person who, or company which, owns or controls a buyer, or gives instructions to the buyer. A person or company owns a buyer when it has more than a 50 % interest in the buyer. A person or company controls a buyer when the person or company is legally or operationally in a position to exercise restraint or direction over the buyer, which is presumed at a 25 % interest. If ownership of a buyer is shown, separate control of it is presumed not to exist unless established otherwise. There may be more than one buyer of any one vessel; (g) \u2018company\u2019 means any company or firm constituted under civil or commercial law, including cooperative societies, and other legal persons governed by public or private law, including those which are non-profitmaking; (h) \u2018Contracting Party\u2019 means any third country that is party to the Shipbuilding Agreement. Article 2 Determination of injurious pricing 1. The normal value shall normally be based on the price paid or payable, in the ordinary course of trade, for a like vessel by an independent buyer in the exporting country. 2. Prices between parties which appear to be associated or to have a compensatory arrangement with each other may not be considered to be in the ordinary course of trade and may not be used to establish the normal value unless it is determined that they are unaffected by the relationship. 3. When there are no sales of like vessels in the ordinary course of trade, or where, because of the particular market situation, such sales do not permit a proper comparison, the normal value of the like vessel shall be calculated on the basis of the export price of a like vessel, in the ordinary course of trade, to an appropriate third country, provided that this price is representative. If such sales to any appropriate third country do not exist or do not permit a proper comparison, the normal value of the like vessels shall be calculated on the basis of the cost of production in the country of origin plus a reasonable amount for selling, general and administrative costs and for profits. 4. Sales of like vessels in the domestic market of the exporting country, or export sales to a third country, at prices below unit production costs (fixed and variable) plus selling, general and administrative costs, may be treated as not being in the ordinary course of trade by reason of price, and may be disregarded in determining the normal value, only if it is determined that such sales are at prices which do not provide for the recovery of all costs within a reasonable period, which should normally be 5 years. 5. Costs shall normally be calculated on the basis of records kept by the shipbuilder under investigation, provided that such records are in accordance with the generally accepted accounting principles of the country concerned and that it is shown that the records reasonably reflect the costs associated with the production and sale of the vessel under consideration. Consideration shall be given to evidence submitted on the proper allocation of costs, provided that it is shown that such allocations have been historically utilised. In the absence of a more appropriate method, preference shall be given to the allocation of costs on the basis of turnover. Unless already reflected in the cost allocations under this subparagraph, costs shall be adjusted appropriately for those non-recurring items of cost which benefit future and/or current production, or for circumstances in which costs are affected by start-up operations. 6. The amounts for selling, for general and administrative costs and for profits shall be based on actual data pertaining to production and sales, in the ordinary course of trade, of like vessels by the shipbuilder under investigation. When such amounts cannot be determined on that basis, the amounts may be determined on the basis of: (a) the weighted average of the actual amounts determined for other shipbuilders of the country of origin in respect of production and sales of like vessels in that country's domestic market; (b) the actual amounts applicable to production and sales, in the ordinary course of trade, of the same general category of vessels for the shipbuilder in question in the domestic market of the country of origin; (c) any other reasonable method, provided that the amount for profit so established shall not exceed the profit normally realised by other shipbuilders on sales of vessels of the same general category in the domestic market of the country of origin. Furthermore, the profit added in constructing value shall, in all instances, be based upon the average profit realised over a reasonable period of time of normally 6 months both before and after the sale under investigation and shall reflect a reasonable profit at the time of such sale. In making such calculation, any distortion which is demonstrated to result in a profit which is not a reasonable one at the time of the sale shall be eliminated. 7. Given the long lead time between contract and delivery of vessels, a normal value shall not include actual costs which the shipbuilder demonstrates are due to force majeure and are significantly above the cost increase which the shipbuilder could reasonably have anticipated and taken into account when the material terms of sales were fixed. 8. In the case of sales from non-market-economy countries and, in particular, those to which Regulation (EU) 2015/755 of the European Parliament and of the Council (6) applies, the normal value shall be determined on the basis of the price or constructed value in a market-economy third country, or the price from such a third country to other countries, including the Union, or, where those are not possible, on any other reasonable basis, including the price actually paid or payable in the Union for the like vessel, duly adjusted if necessary to include a reasonable profit margin. An appropriate market-economy third country shall be selected in a not unreasonable manner, due account being taken of any reliable information made available at the time of selection. Account shall also be taken of time limits. The parties to the investigation shall be informed, shortly after its initiation, of the market-economy third country envisaged and shall be given 10 days to comment. 9. The export price shall be the price actually paid or payable for the vessel under consideration. 10. In cases where there is no export price or where it appears that the export price is unreliable because of an association or a compensatory arrangement between the shipbuilder and the buyer or a third party, the export price may be constructed on the basis of the price at which the vessel is first resold to an independent buyer, or, if the vessel is not resold to an independent buyer or is not resold in the condition in which it was originally sold, on any reasonable basis. In those cases, adjustment for all costs, including duties and taxes, incurred between the original sale and resale, and for profits accruing, shall be made so as to establish a reliable export price. The items for which adjustment shall be made shall include those normally borne by a buyer but paid by any party, either inside or outside the Union, which appears to be associated or to have a compensatory arrangement with the shipbuilder or buyer, including usual transport, insurance, handling, loading and ancillary costs, customs duties, and other taxes payable in the importing country by reason of the purchase of the vessel, and a reasonable margin for selling, general and administrative costs, and profit. 11. A fair comparison shall be made between the export price and the normal value. This comparison shall be made at the same level of trade and in respect of sales made at, as closely as possible, the same time, which will normally mean sales that take place within 3 months before or after the sale under investigation, or in the absence of such sales, any appropriate period. Due allowance shall be made in each case, on its merits, for differences which affect price comparability, including differences in conditions and terms of sale, contractual penalties, taxation, level of trade, quantities, physical characteristics, and any other differences which are also demonstrated to affect price comparability. Where, in cases referred to in paragraph 10, price comparability has been affected, the normal value shall be established at a level of trade equivalent to the level of trade of the constructed export price, or due allowance made, as warranted, under this paragraph. Any duplication when making adjustments shall be avoided, in particular in relation to discounts and contractual penalties. When the price comparison requires a conversion of currencies, such conversion shall be made using the rate of exchange on the date of sale, except that when a sale of foreign currency on forward markets is directly linked to the export sale involved the rate of exchange in the forward sale shall be used. For the purpose of this provision, the date of sale shall be the date on which the material terms of sale are established, normally the date of contract. However, if the material terms of sale are significantly changed on another date, the rate of exchange on the date of the change should be applied. In such a case, appropriate adjustments shall be made to take into account any unreasonable effect on the injurious pricing margin due solely to exchange rate fluctuations between the original date of sale and the date of the change. 12. Subject to the relevant provisions governing fair comparison, the existence of injurious pricing margins shall normally be established on the basis of a comparison of a weighted average normal value with a weighted average of prices of all sales, or by a comparison of individual normal values and individual export prices on a transaction-to-transaction basis. However, a normal value established on a weighted average basis may be compared to prices of all individual sales, if there is a significant difference in the pattern of export prices among different purchasers, regions or time periods, and should the methods specified in the first sentence of this paragraph not reflect the full degree of injurious pricing being practised. 13. The injurious pricing margin shall be the amount by which the normal value exceeds the export price. Where injurious pricing margins vary, a weighted average injurious pricing margin may be established. Article 3 Determination of injury 1. Pursuant to this Regulation, the term \u2018injury\u2019 shall, unless otherwise specified, be taken to mean material injury to the Union industry, threat of material injury to the Union industry or material retardation of the establishment of such an industry and shall be interpreted in accordance with the provisions of this Article. 2. A determination of injury shall be based on positive evidence and shall involve an objective examination of: (a) the effect of the sale at less than normal value on prices in the Union market for like vessels; and (b) the consequent impact of that sale on the Union industry. 3. With regard to the effect of the sale at less than normal value on prices, consideration shall be given to whether there has been significant price undercutting by the sale at less than normal value as compared with the price of like vessels of the Union industry, or whether the effect of such sale is otherwise to depress prices to a significant degree or prevent price increases, which would otherwise have occurred, to a significant degree. No one or more of those factors can necessarily give decisive guidance. 4. Where sales of vessels from more than one country are simultaneously subject to injurious pricing investigations, the effects of such sales shall be cumulatively assessed only if it is determined that: (a) the margin of injurious pricing established in relation to the purchases from each country is more than de minimis as defined in Article 7(3); and (b) a cumulative assessment of the effects of the sales is appropriate in the light of the conditions of competition between vessels sold by non-Union shipbuilders to the buyer and the conditions of competition between such vessels and the like Union vessels. 5. The examination of the impact of the sale at less than normal value on the Union industry concerned shall include an evaluation of all relevant economic factors and indices having a bearing on the state of the industry, including the fact that an industry is still in the process of recovering from the effects of past dumping, injurious pricing or subsidisation; the magnitude of the actual margin of injurious pricing; actual and potential decline in sales, profits, output, market share, productivity, return on investments and utilisation of capacity; factors affecting Union prices; actual and potential negative effects on cash flow, inventories, employment, wages, growth, ability to raise capital or investments. This list is not exhaustive, nor can any one or more of these factors necessarily give decisive guidance. 6. It must be demonstrated, from all the relevant evidence presented in relation to paragraph 2, that the sale at less than normal value is causing, or has caused, injury within the meaning of this Regulation. Specifically, that shall entail demonstrating that the price levels identified pursuant to paragraph 3 are responsible for an impact on the Union industry as provided for in paragraph 5, and that that impact exists to a degree which enables it to be classified as material. 7. Known factors, other than the sale at less than normal value, which at the same time are injuring the Union industry shall also be examined to ensure that the injury caused by those other factors is not attributed to the sale at less than normal value under paragraph 6. Factors which may be considered in that respect shall include: the volume and prices of sales by shipbuilders of countries other than the exporting country not realised at less than normal value; contraction in demand or changes in the patterns of consumption; restrictive trade practices of, and competition between, third country and Union producers; developments in technology; and the export performance and productivity of the Union industry. 8. The effect of the sale at less than normal value shall be assessed in relation to the production of the Union industry of like vessels when available data permit the separate identification of that production on the basis of criteria such as the production process, producers' sales and profits. If such separate identification of that production is not possible, the effects of the sale at less than normal value shall be assessed by examination of the production of the narrowest group or range of vessels, which includes the like vessel, for which the necessary information can be provided. 9. A determination of a threat of material injury shall be based on facts and not merely on allegation, conjecture or remote possibility. The change in circumstances which would create a situation in which the sale at less than normal value would cause injury must have been clearly foreseen and must be imminent. In making a determination regarding the existence of a threat of material injury, consideration should be given to factors such as: (a) whether there is sufficient freely disposable capacity on the part of the shipbuilder or an imminent and substantial increase in such capacity indicating the likelihood of substantially increased sales at less than normal value, account being taken of the availability of other export markets to absorb any additional exports; (b) whether vessels are being exported at prices that would, to a significant degree, depress prices or prevent price increases which otherwise would have occurred, and would probably increase demand for further purchases from other countries. No one of the factors listed above by itself can necessarily give decisive guidance, but the totality of the factors considered shall be such as to lead to the conclusion that further sales at less than normal value are imminent and that, unless protective action is taken, material injury will occur. Article 4 Definition of Union industry 1. For the purposes of this Regulation, the term \u2018Union industry\u2019 shall be interpreted as referring to the Union producers as a whole capable of producing a like vessel with their present facilities or whose facilities can be adapted in a timely manner to produce a like vessel, or to those of them whose collective capability to produce a like vessel constitutes a major proportion, as defined in Article 5(6), of the total Union capability to produce a like vessel. However, when producers are related to the shipbuilder, exporters or buyers, or are themselves buyers of the allegedly injuriously priced vessel, the term \u2018Union industry\u2019 may be interpreted as referring to the rest of the producers. 2. For the purpose of paragraph 1, producers shall be considered to be related to the shipbuilder, exporters or buyers only if: (a) one of them directly or indirectly controls the other; (b) both of them are directly or indirectly controlled by a third person; or (c) together they directly or indirectly control a third person, provided that there are grounds for believing or suspecting that the effect of the relationship is such as to cause the producer concerned to behave differently from non-related producers. For the purpose of this paragraph, one shall be deemed to control another when the former is legally or operationally in a position to exercise restraint or direction over the latter. 3. The provisions of Article 3(8) shall be applicable to this Article. Article 5 Initiation of proceedings 1. Except as provided for in paragraph 8, an investigation to determine the existence, degree and effect of any alleged injurious pricing shall be initiated upon a written complaint by any natural or legal person, or any association not having legal personality, acting on behalf of the Union industry. The complaint may be submitted to the Commission or to a Member State, which shall forward it to the Commission. The Commission shall send Member States a copy of any complaint it receives. The complaint shall be deemed to have been lodged on the first working day following its delivery to the Commission by registered mail or the issuing of an acknowledgement of receipt by the Commission. Where, in the absence of any complaint, a Member State is in possession of sufficient evidence of injurious pricing and of resultant injury to the Union industry, it shall immediately communicate such evidence to the Commission. 2. A complaint under paragraph 1 shall be filed no later than: (a) 6 months from the time that the complainant knew, or should have known, of the sale of the vessel, when: (i) the complainant was invited to tender a bid on the contract at issue through a broad multiple bid or any other bidding process; (ii) the complainant actually did tender a bid; and (iii) the bid of the complainant substantially met bid specifications; (b) 9 months from the time that the complainant knew, or should have known, of the sale of the vessel in the absence of an invitation to tender, provided that a notice of intent to apply, including information reasonably available to the complainant to identify the transaction concerned, had been submitted no later than 6 months from that time to the Commission or a Member State. In no event shall a complaint be filed later than 6 months from the date of delivery of the vessel. The complainant may be considered to have known of the sale of a vessel from the time of publication of the fact of the conclusion of the contract, along with very general information concerning the vessel, in the international trade press. For the purpose of this Article, a broad multiple bid shall be interpreted to mean a bid in which the proposed buyer extends an invitation to bid to at least all the shipbuilders known to the buyer to be capable of building the vessel in question. 3. A complaint under paragraph 1 shall include evidence: (a) of injurious pricing; (b) of injury; (c) of a causal link between the injuriously priced sale and the alleged injury; and (d) (i) that, if the vessel was sold through a broad multiple bid, the complainant was invited to tender a bid on the contract at issue, it actually did so, and the bid of the complainant substantially met bid specifications (namely, delivery date and technical requirements); or (ii) that, if the vessel was sold through any other bidding process and the complainant was invited to tender a bid on the contract at issue, it actually did so, and the bid of the complainant substantially met bid specifications; or (iii) that, in the absence of an invitation to tender a bid other than under a broad multiple bid, the complainant was capable of building the vessel concerned and, if the complainant knew, or should have known, of the proposed purchase, it made demonstrable efforts to conclude a sale with the buyer consistent with the bid specifications in question. The complainant may be considered to have known of the proposed purchase if it is demonstrated that the majority of the relevant industry has made efforts with that buyer to conclude a sale of the vessel in question, or if it is demonstrated that general information on the proposed purchase was available from brokers, financiers, classification societies, charterers, trade associations, or other entities normally involved in shipbuilding transactions with whom the complainant had regular contacts or dealings. 4. The complaint shall contain such information as is reasonably available to the complainant on the following: (a) the identity of the complainant and a description of the volume and value of the Union production of the like vessel by the complainant. Where a written complaint is made on behalf of the Union industry, the complaint shall identify the industry on behalf of which the complaint is made by a list of all known Union producers capable of building the like vessel and, to the extent possible, a description of the volume and value of Union production of the like vessel accounted for by such producers; (b) a complete description of the allegedly injuriously priced vessel, the names of the country or countries of origin or export in question, the identity of each known exporter or foreign producer and the identity of the buyer of the vessel in question; (c) the prices at which such vessels are sold in the domestic markets of the country or countries of origin or export (or, where appropriate, the prices at which such vessels are sold from the country or countries of origin or export to a third country or countries or the constructed value of the vessel) and the export prices or, where appropriate, the prices at which such vessels are first resold to an independent buyer; (d) the effect of the injuriously priced sale on prices of the like vessel on the Union market and the consequent impact of the sale on the Union industry, as demonstrated by relevant factors and indices having a bearing on the state of the Union industry, such as those listed in Article 3(3) and (5). 5. The Commission shall, as far as possible, examine the accuracy and adequacy of the evidence provided in the complaint, to determine whether there is sufficient evidence to justify the initiation of an investigation. 6. An investigation shall not be initiated pursuant to paragraph 1 unless it has been determined, on the basis of an examination as to the degree of support for, or opposition to, the complaint expressed by Union producers capable of building the like vessel, that the complaint has been made by, or on behalf of, the Union industry. The complaint shall be considered to have been made by, or on behalf of, the Union industry if it is supported by those Union producers whose collective capacity to produce the like vessel constitutes more than 50 % of the total capacity of that portion of the Union industry expressing either support for, or opposition to, the complaint. However, no investigation shall be initiated where Union producers expressly supporting the complaint account for less than 25 % of total capacity of the Union producers capable of producing the like vessel. 7. The authorities shall avoid, unless a decision has been taken to initiate an investigation, any publicising of the complaint seeking the initiation of an investigation. However, before proceeding to initiate an investigation, the government of the exporting country concerned shall be notified. 8. If, in special circumstances, the Commission decides to initiate an investigation without having received a written complaint by, or on behalf of, the Union industry for the initiation of such investigation, this shall be done on the basis of sufficient evidence of injurious pricing, injury, a causal link, and that a member of the allegedly injured Union industry met the criteria referred to in paragraph 3 (d), to justify such initiation. Where appropriate, an investigation may also be initiated upon a written complaint by the authorities of a Contracting Party. Such a complaint shall be supported by sufficient evidence to show that a vessel is being, or has been, injuriously priced and that the alleged sale to a Union buyer at less than normal value is causing, or has caused, injury to the domestic industry of the Contracting Party concerned. 9. The evidence of both injurious pricing and injury shall be considered simultaneously in the decision on whether or not to initiate an investigation. A complaint shall be rejected where there is insufficient evidence of either injurious pricing or of injury to justify proceeding with the case. 10. The complaint may be withdrawn prior to initiation, in which case it shall be considered not to have been lodged. 11. Where it is apparent that there is sufficient evidence to justify initiating proceedings, the Commission shall do so within 45 days of the date on which the complaint was lodged, or, in the case of initiation pursuant to paragraph 8, no later than 6 months from the time the sale of the vessel was known or should have been known, and shall publish a notice in the Official Journal of the European Union. Where insufficient evidence has been presented, the complainant shall be so informed within 45 days of the date on which the complaint is lodged with the Commission. The Commission shall provide information to the Member States once it has determined that there is a need to initiate such proceedings. 12. The notice of initiation of the proceedings shall announce the initiation of an investigation, indicate the name and country of the shipbuilder and the buyer or buyers and a description of the vessel concerned, give a summary of the information received, and provide that all relevant information is to be communicated to the Commission. It shall state the periods within which interested parties may make themselves known, present their views in writing and submit information if such views and information are to be taken into account during the investigation. It shall also state the period within which interested parties may apply to be heard by the Commission in accordance with Article 6(5). 13. The Commission shall advise the exporter, the buyer or buyers of the vessel and representative associations of producers, exporters or buyers of such vessels known to it to be concerned, as well as representatives of the country the vessel of which is subject to such investigation and the complainants, of the initiation of the proceedings and, with due regard to the protection of confidential information, provide the full text of the written complaint received pursuant to paragraph 1 to the exporter, and to the authorities of the exporting country, and make it available upon request to other interested parties involved. Article 6 The investigation 1. Following the initiation of the proceedings, the Commission, acting in cooperation with the Member States and, where appropriate, with the authorities of third countries, shall commence an investigation at Union level. Such an investigation shall cover both injurious pricing and injury, and they shall be investigated simultaneously. 2. Parties receiving questionnaires used in an injurious pricing investigation shall be given at least 30 days to reply. The time-limit for exporters shall be counted from the date of receipt of the questionnaire, which for this purpose shall be deemed to have been received 1 week from the day on which it was sent to the exporter or transmitted to the appropriate diplomatic representative of the exporting country. An extension to the 30-day period may be granted, due account being taken of the time limits of the investigation, provided that the party shows due cause for such an extension in terms of its particular circumstances. 3. The Commission may request the authorities of third countries, where appropriate, as well as the Member States, to supply information, and Member States shall take whatever steps are necessary in order to give effect to such requests. They shall send to the Commission the information requested together with the results of all inspections, checks or investigations carried out. Where that information is of general interest or where its transmission has been requested by a Member State, the Commission shall forward it to the Member States, provided that it is not confidential, in which case a non-confidential summary shall be forwarded. 4. The Commission may request the authorities of third countries, where appropriate, as well as the Member States, to carry out all necessary checks and inspections, particularly amongst Union producers, and to carry out investigations in third countries, provided that the firms concerned give their consent and that the government of the country in question has been officially notified and raises no objection. Member States shall take whatever steps are necessary in order to give effect to such requests from the Commission. Officials of the Commission shall be authorised, if the Commission or a Member State so requests, to assist the officials of Member States in carrying out their duties. Likewise, officials of the Commission may assist the officials of the authorities of third countries in carrying out their duties, upon agreement between the Commission and such authorities. 5. The interested parties which have made themselves known in accordance with Article 5(12) shall be heard if they have, within the period prescribed in the notice published in the Official Journal of the European Union, made a written request for a hearing showing that they are an interested party likely to be affected by the result of the proceedings and that there are particular reasons why they should be heard. 6. Opportunities shall, on request, be provided for the shipbuilder, the buyer or buyers, representatives of the government of the exporting country, the complainants, and other interested parties, which have made themselves known in accordance with Article 5(12), to meet those parties with adverse interests, so that opposing views may be presented and rebuttal arguments offered. Provision of such opportunities shall take account of the need to preserve confidentiality and of the convenience to the parties. There shall be no obligation on any party to attend a meeting, and failure to do so shall not be prejudicial to that party's case. Oral information provided under this paragraph shall be taken into account insofar as it is subsequently confirmed in writing. 7. The complainants, the shipbuilder, the buyer or buyers and other interested parties, which have made themselves known in accordance with Article 5(12), as well as the representatives of the exporting country, may, upon written request, inspect all information, made available by any party to an investigation, as distinct from internal documents prepared by the authorities of the Union or its Member States, which is relevant to the presentation of their cases and not confidential within the meaning of Article 13, and is used in the investigation. Such parties may respond to such information and their comments shall be taken into consideration, wherever they are sufficiently substantiated in the response. 8. Except in the circumstances provided for in Article 12, the information which is supplied by interested parties and upon which findings are based shall be examined for accuracy as far as possible. 9. For proceedings involving price to price comparison, where a like vessel has been delivered, the investigation shall be concluded no later than 1 year from the date of initiation. For proceedings in which the like vessel is under construction, the investigation shall be concluded no later than 1 year from the date of delivery of that like vessel. Investigations involving constructed value shall be concluded within 1 year of their initiation or within 1 year of delivery of the vessel, whichever is the later. Those time limits shall be suspended to the extent that Article 16(2) is applied. Article 7 Termination without measures, imposition and collection of injurious pricing charges 1. Where the complaint is withdrawn, the proceedings may be terminated. 2. Where measures are unnecessary, the investigation or proceedings shall be terminated. The Commission shall terminate the investigation in accordance with the examination procedure referred to in Article 10(2). 3. There shall be immediate termination of the proceedings where it is determined that the margin of injurious pricing is less than 2 %, expressed as a percentage of the export price. 4. Where the facts as finally established show that there is injurious pricing and injury caused thereby, an injurious pricing charge shall be imposed on the shipbuilder by the Commission acting in accordance with the examination procedure referred to in Article 10(2). The amount of the injurious pricing charge shall be equal to the margin of injurious pricing established. The Commission shall, after having informed the Member States, take the necessary measures for the implementation of its decision, in particular the collection of the injurious pricing charge. 5. The shipbuilder shall pay the injurious pricing charge within 180 days of notification to it of the imposition of the charge, which for this purpose shall be deemed to have been received 1 week from the day on which it was sent to the shipbuilder. The Commission may give the shipbuilder a reasonably extended period of time to pay where the shipbuilder demonstrates that payment within 180 days would render it insolvent or would be incompatible with a judicially supervised reorganisation, in which case interest shall accrue on any unpaid portion of the charge, at a rate equal to the secondary market yield on medium-term euro bonds in the Luxembourg stock exchange plus 50 basis points. Article 8 Alternative remedies The investigation may be terminated without the imposition of an injurious pricing charge if the shipbuilder definitively and unconditionally voids the sale of the injuriously priced vessel or complies with an alternative, equivalent remedy accepted by the Commission. A sale shall be considered to have been voided only where all contractual relationships between the parties concerned by the sale in question have been terminated, all consideration paid in connection with the sale is reimbursed and all rights in the vessel concerned or parts thereof are returned to the shipbuilder. Article 9 Countermeasures \u2014 denial of loading and unloading rights 1. If the shipbuilder concerned does not pay the injurious pricing charge imposed under Article 7, countermeasures under the form of denial of loading and unloading rights shall be imposed by the Commission on the vessels built by the shipbuilder in question. The Commission shall provide information to the Member States once the grounds for countermeasures referred to in the first subparagraph arise. 2. The decision imposing the countermeasures shall enter into force 30 days after its publication in the Official Journal of the European Union and shall be repealed on full payment of the injurious pricing charge by the shipbuilder. The countermeasure shall cover all vessels contracted for during a period of 4 years from the date of entry into force of the decision. Each vessel shall be subject to the countermeasure for a period of 4 years after its delivery. Such periods may be reduced only following and in accordance with the outcome of an international dispute settlement procedure concerning the countermeasures imposed. The vessels subject to the denial of loading and unloading rights shall be specified by decision to be adopted by the Commission and published in the Official Journal of the European Union. 3. The Member States' customs authorities shall not grant permission to load or unload to vessels subject to the denial of loading and unloading rights. Article 10 Committee procedure 1. The Commission shall be assisted by the Committee established by Regulation (EU) 2016/1036. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 11 Verification visits 1. The Commission shall, where it considers it appropriate, carry out visits to examine the records of exporters, shipbuilders, traders, agents, producers, trade associations and organisations, to verify information provided on injurious pricing and injury. In the absence of a proper and timely reply, the Commission may choose not to carry out a verification visit. 2. The Commission may carry out investigations in third countries as required, provided that it obtains the agreement of the firms concerned, that it notifies the representatives of the government of the country in question and that the latter does not object to the investigation. As soon as the agreement of the firms concerned has been obtained, the Commission shall notify the authorities of the exporting country of the names and addresses of the firms to be visited and the dates agreed. 3. The firms concerned shall be advised of the nature of the information to be verified during verification visits and of any further information which needs to be provided during such visits, though this does not preclude requests, made during the verification, for further details to be provided in the light of information obtained. 4. In investigations carried out under paragraphs 1, 2 and 3, the Commission shall be assisted by officials of those Member States which so request. Article 12 Non-cooperation 1. In cases in which any interested party refuses access to, or otherwise does not provide, necessary information within the time limits provided for in this Regulation, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made on the basis of the facts available. Where it is found that any interested party has supplied false or misleading information, that information shall be disregarded and use may be made of facts available. Interested parties shall be made aware of the consequences of non-cooperation. 2. Failure to give a computerised response shall not be deemed to constitute non-cooperation, provided that the interested party shows that presenting the response as requested would result in an unreasonable extra burden or unreasonable additional cost. 3. Where the information submitted by an interested party is not ideal in all respects, it shall nevertheless not be disregarded, provided that any deficiencies are not such as to cause undue difficulty in arriving at a reasonably accurate finding and that the information is appropriately submitted in good time and is verifiable, and that the party has acted to the best of its ability. 4. If evidence or information is not accepted, the supplying party shall be informed forthwith of the reasons therefor and shall be granted an opportunity to provide further explanations within the time limit specified. If the explanations are considered unsatisfactory, the reasons for rejection of such evidence or information shall be disclosed and given in published findings. 5. If determinations, including those regarding normal value, are based on the provisions of paragraph 1, including the information supplied in the complaint, it shall, where practicable and with due regard to the time limits of the investigation, be checked by reference to information from other independent sources which may be available, such as published price lists, official statistics of sales and customs returns, or information obtained from other interested parties during the investigation. 6. If an interested party does not cooperate, or cooperates only partially, so that relevant information is thereby withheld, the result of the investigation may be less favourable to the party than if it had cooperated. Article 13 Confidentiality 1. Any information which is by nature confidential (for example, because its disclosure would be of significant competitive advantage to a competitor or would have a significantly adverse effect upon a person supplying the information or upon a person from whom the person supplying the information has acquired the information) or which is provided on a confidential basis by parties to an investigation shall, if good cause is shown, be treated as such by the authorities. 2. Interested parties providing confidential information shall be required to provide non-confidential summaries thereof. Those summaries shall be in sufficient detail to permit a reasonable understanding of the substance of the information submitted in confidence. In exceptional circumstances, such parties may indicate that such information is not capable of being summarised. In such exceptional circumstances, a statement of the reasons why summarisation is not possible shall be provided. 3. If it is considered that a request for confidentiality is not warranted and if the supplier of the information is either unwilling to make the information available or to authorise its disclosure in generalised or summary form, such information may be disregarded unless it can be satisfactorily demonstrated from appropriate sources that the information is correct. Requests for confidentiality shall not be arbitrarily rejected. 4. This Article shall not preclude the disclosure of general information by the Union authorities, and, in particular, of the reasons on which decisions taken pursuant to this Regulation are based, or disclosure of the evidence relied on by the Union authorities insofar as is necessary to explain those reasons in court proceedings. Such disclosure shall take into account the legitimate interest of the parties concerned that their business secrets not be divulged. 5. The Commission and the Member States, including the officials of either, shall not reveal any information received pursuant to this Regulation for which confidential treatment has been requested by its supplier, without specific permission from that supplier. Exchanges of information between the Commission and Member States, or any internal documents prepared by the authorities of the Union or the Member States, shall not be divulged except as specifically provided for in this Regulation. 6. Information received pursuant to this Regulation shall be used only for the purpose for which it was requested. Article 14 Disclosure 1. The complainants, the shipbuilder, the exporter, the buyer or the buyers of the vessel and their representative associations, and representatives of the exporting country, may request disclosure of the details underlying the essential facts and considerations on the basis of which it is intended to recommend the imposition of an injurious pricing charge, or the termination of an investigation or proceedings without the imposition of a charge. 2. Requests for final disclosure, as defined in paragraph 1, shall be addressed to the Commission in writing and be received within time limits set by the Commission. 3. Final disclosure shall be given in writing. It shall be made, due regard being had to the need to protect confidential information, as soon as possible and, normally, not less than 1 month before a definitive decision. Where the Commission is not in a position to disclose certain facts or considerations at that time, they shall be disclosed as soon as possible thereafter. Disclosure shall not prejudice any subsequent decision which may be taken by the Commission, but where such a decision is based on any different facts and considerations they shall be disclosed as soon as possible. 4. Representations made after disclosure is given shall be taken into consideration only if received within a period to be set by the Commission in each case, which shall be at least 10 days, due consideration being given to the urgency of the matter. Article 15 Report The Commission shall include information on the implementation of this Regulation in its annual report on the application and implementation of trade defence measures presented to the European Parliament and to the Council pursuant to Article 23 of Regulation (EU) 2016/1036. Article 16 Final provisions 1. This Regulation shall not preclude the application of: (a) any special rules laid down in agreements concluded between the Union and third countries; (b) special measures, provided that such action does not run counter to obligations pursuant to the Shipbuilding Agreement. 2. An investigation pursuant to this Regulation shall not be carried out and measures shall not be imposed or maintained where such measures would be contrary to the Union's obligations emanating from the Shipbuilding Agreement or any other relevant international agreement. This Regulation shall not prevent the Union from fulfilling its obligations under the provisions of the Shipbuilding Agreement concerning dispute settlement. Article 17 Repeal Regulation (EC) No 385/96 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 18 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from the date of entry into force of the Shipbuilding Agreement (7). It shall not apply to vessels contracted for before the date of entry into force of the Shipbuilding Agreement, except for vessels contracted for after 21 December 1994 and for delivery more than 5 years from the date of the contract. Such vessels shall be subject to this Regulation, unless the shipbuilder demonstrates that the extended delivery date was for normal commercial reasons and not to avoid the application of this Regulation. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 8 June 2016. For the European Parliament The President M. SCHULZ For the Council The President A.G. KOENDERS (1) Position of the European Parliament of 7 July 2015 (not yet published in the Official Journal) and decision of the Council of 15 January 2016. (2) Council Regulation (EC) No 385/96 of 29 January 1996 on protection against injurious pricing of vessels (OJ L 56, 6.3.1996, p. 21). (3) See Annex I. (4) Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (see page 21 of this Official Journal). (5) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (6) Regulation (EU) 2015/755 of the European Parliament and of the Council of 29 April 2015 on common rules for imports from certain third countries (OJ L 123, 19.5.2015, p. 33). (7) The date of entry into force of the Shipbuilding Agreement will be published in the Official Journal of the European Union, L series. ANNEX I REPEALED REGULATION WITH THE AMENDMENT THERETO Council Regulation (EC) No 385/96 (OJ L 56, 6.3.1996, p. 21) Regulation (EU) No 37/2014 of the European Parliament and of the Council (OJ L 18, 21.1.2014, p. 1) Only point 5 of the Annex ANNEX II CORRELATION TABLE Regulation (EC) No 385/96 This Regulation Articles 1 to 4 Articles 1 to 4 Article 5(1) Article 5(1) Article 5(2), first subparagraph, introductory wording Article 5(2), first subparagraph, introductory wording Article 5(2), first subparagraph, point (a), introductory wording Article 5(2), first subparagraph, point (a), introductory wording Article 5(2), first subparagraph, point (a), first indent Article 5(2), first subparagraph, point (a)(i) Article 5(2), first subparagraph, point (a), second indent Article 5(2), first subparagraph, point (a)(ii) Article 5(2), first subparagraph, point (a), third indent Article 5(2), first subparagraph, point (a)(iii) Article 5(2), second, third and fourth subparagraph Article 5(2), second, third and fourth subparagraph Article 5(3) to (10) Article 5(3) to (10) Article 5(11), first subparagraph Article 5(11), first and second sentence Article 5(11), second subparagraph Article 5(11), third sentence Article 5(12), first sentence Article 5(12), first subparagraph Article 5(12), second and third sentence Article 5(12), second subparagraph Article 6(1) and (2) Article 6(1) and (2) Article 6(3), first sentence Article 6(3), first subparagraph Article 6(3), second sentence Article 6(3), second subparagraph Article 6(3), third sentence Article 6(3), third subparagraph Article 6(4), first sentence Article 6(4), first subparagraph Article 6(4), second sentence Article 6(4), second subparagraph Article 6(4), third and fourth sentence Article 6(4), third subparagraph Article 6(5) Article 6(5) Article 6(6), first sentence Article 6(6), first subparagraph Article 6(6), second sentence Article 6(6), second subparagraph Article 6(6), third sentence Article 6(6), third subparagraph Article 6(6), fourth sentence Article 6(6), fourth subparagraph Article 6(7), first sentence Article 6(7), first subparagraph Article 6(7), second sentence Article 6(7), second subparagraph Article 6(8) and (9) Article 6(8) and (9) Articles 7 to 11 Articles 7 to 11 Article 12(1), first sentence Article 12(1), first subparagraph Article 12(1), second sentence Article 12(1), second subparagraph Article 12(1), third sentence Article 12(1), third subparagraph Article 12(2) to (6) Article 12(2) to (6) Article 13 Article 13 Article 14(1) and (2) Article 14(1) and (2) Article 14(3), first, second and third sentence Article 14(3), first subparagraph Article 14(3), fourth sentence Article 14(3), second subparagraph Article 14(4) Article 14(4) Article 14a Article 15 Article 15 Article 16 \u2014 Article 17 Article 16 Article 18 \u2014 Annex I \u2014 Annex II", "summary": "Anti-dumping protection \u2014 shipbuilding industry Anti-dumping protection \u2014 shipbuilding industry SUMMARY OF: Regulation (EU) 2016/1035 \u2014 rules to ensure shipping vessels are not sold at prices below their true value WHAT IS THE AIM OF THIS REGULATION? It seeks to protect EU shipbuilders by ensuring that ships are not sold below their normal value* in the EU by their non-EU competitors. It codifies and repeals Regulation (EC) No 385/96 which had been amended a number of times. KEY POINTS The regulation translates into EU law the Shipbuilding Injurious Pricing (IPI) Code, which is annexed to the Organisation for Economic Cooperation and Development (OECD) Shipbuilding Agreement of 1994. The regulation is based on the principle that a harmful pricing charge may be levied on the builder of an injuriously priced* vessel whose sale to a buyer outside the country in which the vessel originates causes injury to EU industry. This means that an assessment needs to be made of the capability in the EU to produce a like vessel (i.e. of the same type, purpose and approximate size as the vessel under consideration and possessing characteristics closely resembling it). The regulation applies to all self-propelled sea-going vessels of 100 gross tonnes and above, used for transportation of goods or passengers or for the performance of a specialised service (for example, ice breakers and dredgers). It also covers tugboats of 365 kW and above. The regulation lays down: detailed rules on how to calculate normal value; guidance as to the possible relevant factors to determine whether the injuriously priced sale has caused material injury or is threatening to cause injury. EU market conditions need to be taken into account in order to demonstrate that the price level of the sale concerned is responsible for injury sustained by the EU industry; conditions \u2014 both procedural and substantive \u2014 for an EU shipbuilder to lodge a complaint against injurious pricing, including the extent to which it should be supported by the EU shipbuilding industry; procedures for the European Commission to reject complaints or initiate proceedings; rules and procedures governing the Commission\u2019s investigation, such as: how interested parties should make themselves known,present their views and submit information within specified time limits, if such views and information are to be taken into account; rules on the termination of cases. Whether or not an injurious pricing charge is imposed on a shipbuilder, an investigation should be terminated no later than 1 year from the date of its initiation or the date of delivery of the vessel, whichever is the later. The investigation may be terminated without imposing an injurious pricing charge if the sale of the injuriously priced vessel is definitively and unconditionally voided or if an alternative equivalent remedy is accepted; rules preventing vessels built by shipbuilders who are subject to sanctions from loading and unloading in EU ports; rules allowing the Commission to carry out visits to verify information about injurious pricing and injury; rules on confidentiality to ensure that parties\u2019 business secrets are not divulged in the course of the investigation. FROM WHEN DOES THE REGULATION APPLY? It applies from the date on which the Shipbuilding Agreement enters into force. BACKGROUND The goal of the Shipbuilding Agreement is to establish, in a legally binding manner, normal, i.e. subsidy and dumping-free, competitive conditions in the shipbuilding industries of OECD countries. The agreement has not, as yet, come into force. For more information, see: Shipbuilding sector (European Commission). KEY TERMS Normal value: the price paid or payable, in the ordinary course of trade, for a like vessel by an independent buyer in the exporting country. When there are no sales of like vessels in the ordinary course of trade, or where, because of the particular market situation, such sales do not permit a proper comparison, the normal value of the like vessel is calculated on the basis of the export price of a like vessel, in the ordinary course of trade, to an appropriate non-EU country, provided that this price is representative. If such sales to any appropriate non-EU country do not exist or do not permit a proper comparison, the normal value of the like vessels are calculated on the basis of the cost of production in the country of origin plus a reasonable amount for selling, general and administrative costs and for profits. Injuriously priced: where the export price of the vessel sold is less than a comparable price for a like vessel, when sold to a buyer of the exporting country under normal trading conditions. MAIN DOCUMENT Regulation (EU) 2016/1035 of the European Parliament and of the Council of 8 June 2016 on protection against injurious pricing of vessels (OJ L 176, 30.6.2016, pp. 1-20) last update 18.12.2017"}
{"article": "31.3.2016 EN Official Journal of the European Union L 81/1 REGULATION (EU) 2016/424 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Directive 2000/9/EC of the European Parliament and of the Council (3) lays down rules for cableway installations that are designed, constructed and operated with a view to transporting persons. (2) Directive 2000/9/EC is based on the \u2018new approach\u2019 principles, as set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (4). Thus, it sets out only the essential requirements applying to cableway installations, whereas technical details are adopted by the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (5). Conformity with the harmonised standards so set, the reference numbers of which are published in the Official Journal of the European Union, provides a presumption of conformity with the requirements of Directive 2000/9/EC. Experience has shown that those basic principles have worked well in that sector and should be maintained and even further promoted. (3) Experience acquired from the implementation of Directive 2000/9/EC has shown the need to modify some of its provisions in order to clarify and update them and thus ensure legal certainty, mainly as regards the scope and the conformity assessment of subsystems. (4) Since the scope, essential requirements and conformity assessment procedures have to be identical in all Member States, there is almost no flexibility in transposing a directive based on the new approach principles into national law. In order to simplify the regulatory framework, Directive 2000/9/EC should be replaced by a regulation, which is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for divergent transposition by Member States and thus ensures a uniform implementation throughout the Union. (5) Decision No 768/2008/EC of the European Parliament and of the Council (6) lays down common principles and reference provisions intended to apply across the legislation harmonising the conditions for the marketing of products in order to provide a coherent basis for revision or recasts of that legislation. Directive 2000/9/EC should therefore be adapted to that Decision. (6) Regulation (EC) No 765/2008 of the European Parliament and of the Council (7) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. (7) The scope of this Regulation should reflect the scope of Directive 2000/9/EC. This Regulation should apply to cableway installations designed to transport persons used in particular in high-altitude tourist resorts, in urban transport facilities or in sports facilities. Cableway installations are mainly lift systems, such as funicular railways, aerial ropeways (cable cars, gondolas, chairlifts) and drag lifts. Traction by cable and the passenger transport function are the essential criteria in determining whether a cableway installation is covered by this Regulation. (8) This Regulation should apply in its entirety to new cableway installations, to modifications of cableway installations requiring a new authorisation and covers subsystems and safety components which are new to the Union market when they are placed on it; that is to say, they are either new subsystems and safety components made by a manufacturer established in the Union or subsystems and safety components, whether new or second-hand, imported from a third country. This Regulation does not apply to the relocation of cableway installations installed on the territory of the Union or to the relocation of subsystems or safety components that were incorporated into such installations, except where such relocation implies a major modification of the cableway installation. (9) New types of cableway installations have been developed that are intended for both transport and leisure activities. Such installations should be covered by this Regulation. (10) It is appropriate to exclude certain cableway installations from the scope of this Regulation, either because they are subject to other specific Union harmonisation legislation or because they can be adequately regulated at national level. (11) Lifts, including cable-operated lifts, whether vertical or inclined, permanently serving specific levels of buildings and constructions and not operating between cableway stations, are subject to specific Union legislation and should be excluded from the scope of this Regulation. Cableway installations covered by this Regulation are excluded from the scope of Directive 2014/33/EU of the European Parliament and of the Council (8). (12) Cableway installations that are categorised by Member States as historic, cultural or heritage installations, that entered into service before 1 January 1986 and are still in operation, and that have not had any significant changes in design or construction, should be excluded from the scope of this Regulation. This exclusion also applies to subsystems and safety components specifically designed for such cableway installations. Member States should ensure a high level of protection of the health and safety of persons and of property concerning such cableway installations, if necessary by way of national legislation. (13) In order to ensure legal certainty, the exclusion of cable-operated ferries should cover all cable-operated installations where the users or carriers are waterborne, such as cable-operated waterski installations. (14) In order to ensure that cableway installations and their infrastructure, subsystems and safety components guarantee a high level of protection of the health and safety of persons and of property, it is necessary to lay down rules for the design and the construction of cableway installations. (15) Member States should ensure the safety of cableway installations at the time of their construction, entry into service and during their operation. (16) This Regulation should not affect the right of the Member States to specify the requirements they deem necessary as regards land use and regional planning, and in order to ensure the protection of the environment and of the health and safety of persons, and in particular workers and operating personnel, when using cableway installations. (17) This Regulation should not affect the right of the Member States to specify adequate procedures for the authorisation of planned cableway installations, the inspection of cableway installations prior to their entry into service and their monitoring during operation. (18) This Regulation should take into account the fact that the safety of cableway installations depends equally on the surrounding conditions, on the quality of the industrial goods supplied and on the way in which they are assembled, installed on-site and monitored during operation. The causes of serious accidents may be linked to the choice of site, to the system of transport itself, to the structures, or to the way in which the system is operated and maintained. (19) Although this Regulation does not cover the actual operation of cableway installations, it should provide a general framework intended to ensure that such installations situated on the territory of Member States are operated in such a way as to offer passengers, operating personnel and third parties a high degree of protection. (20) Member States should take the necessary steps to ensure that cableway installations enter into service only if they comply with this Regulation and are not liable to endanger the health or safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose. (21) Member States should lay down procedures for authorising the construction of planned cableway installations and the modification of such installations and for their entry into service in order to ensure that the cableway installation is safely constructed and assembled on-site, in accordance with the safety analysis, the results of which are included in the safety report, and all relevant regulatory requirements. (22) The safety analysis for planned cableway installations should identify the components on which the safety of the cableway installation depends. (23) The safety analysis for planned cableway installations should take into account the constraints linked to the operation of cableway installations, albeit not in such a way as to jeopardise the principle of free movement of goods for subsystems and safety components or the safety of the cableway installations themselves. (24) Rules on authorising the entry into service of cableway installations fall within the competence of Member States. Authorisation for entry into service is granted by the competent authorities or bodies. Monitoring of the operating safety of cableway installations also falls within the competence of Member States. Member States should therefore determine the person responsible for the cableway installation and, accordingly, for the safety analysis of a planned cableway installation. (25) This Regulation aims to ensure the functioning of the internal market for subsystems of cableway installations and for safety components for cableway installations. Subsystems and safety components complying with this Regulation should benefit from the principle of free movement of goods. (26) Subsystems and safety components should be allowed to be incorporated in a cableway installation provided that they permit the construction of cableway installations which comply with this Regulation and are not liable to endanger the health or safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose. (27) The essential requirements should be interpreted and applied so as to take account of the state of the art at the time of design and manufacture as well as of technical and economic considerations which are consistent with a high degree of health and safety protection. (28) Economic operators should be responsible for the compliance of subsystems and safety components with the requirements of this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as the health and safety of persons and protection of property, and to guarantee fair competition on the Union market. (29) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market subsystems and safety components which are in conformity with this Regulation. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain. (30) The manufacturer of subsystems or safety components, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer of the subsystem or the safety component. (31) In order to facilitate communication between economic operators and national market surveillance authorities, Member States should encourage economic operators to include a website address in addition to the postal address. (32) It is necessary to ensure that subsystems and safety components from third countries entering the Union market comply with the requirements of this Regulation, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those subsystems and safety components. Provision should therefore be made for importers to make sure that the subsystems or safety components they place on the market comply with the requirements of this Regulation and that they do not place on the market subsystems and safety components which do not comply with such requirements or present a risk. Provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that subsystem and safety component marking and documentation drawn up by manufacturers are available for inspection by the competent national authorities. (33) The distributor makes a subsystem or a safety component available on the market after it has been placed on the market by the manufacturer or the importer and should act with due care to ensure that its handling of the subsystem or the safety component does not adversely affect its compliance. (34) When placing on the market a subsystem or a safety component, every importer should indicate on the subsystem or safety component his name, registered trade name or registered trade mark and the postal address at which he can be contacted, as well as a website, where available. Exceptions should be provided for in cases where the size or nature of the subsystem or safety component does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the subsystem or safety component. (35) Any economic operator that either places a subsystem or a safety component on the market under his own name or trademark, or modifies a subsystem or a safety component in such a way that compliance with the requirements of this Regulation may be affected, should be considered to be the manufacturer and should assume the obligations of the manufacturer. (36) Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the subsystems or the safety components concerned. (37) Ensuring traceability of a subsystem or a safety component throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant subsystems or safety components available on the market. When keeping the information required under this Regulation for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with a subsystem or safety component or to whom they have supplied a subsystem or a safety component. (38) This Regulation should be limited to the expression of the essential requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for presumption of conformity for cableway installations, subsystems and safety components which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements, especially with regard to the design, construction and operation of cableway installations. (39) Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Regulation. (40) In order to enable economic operators to demonstrate and the competent authorities to ensure that subsystems and safety components made available on the market conform to the essential requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad hoc variants, conformity assessment procedures should be chosen from among those modules. (41) Manufacturers of subsystems and safety components should draw up an EU declaration of conformity to provide information required under this Regulation on the conformity of a subsystem or a safety component with the requirements of this Regulation and of other relevant Union harmonisation legislation. The EU declaration of conformity should accompany the subsystem or safety component. (42) To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts for a subsystem or a safety component should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of the relevant individual declarations of conformity. (43) The CE marking, indicating the conformity of a subsystem or a safety component, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship with other markings are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in this Regulation. (44) A check on compliance of subsystems and safety components with the essential requirements provided for in this Regulation is necessary in order to provide effective protection for passengers, operating personnel and third parties. (45) The conformity assessment procedures set out in this Regulation require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission. (46) Experience has shown that the criteria, set out in Directive 2000/9/EC, that conformity assessment bodies have to fulfil in order to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union. It is, however, essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services. (47) In order to ensure a consistent level of conformity assessment quality, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies. (48) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in this Regulation. (49) The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification. (50) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements. (51) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the subsystems and safety components to be placed on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries. (52) It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification. (53) Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies. (54) In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies. (55) Interested parties should have the right to appeal against the result of a conformity assessment carried out by a notified body. For that reason, it is important to ensure that an appeal procedure against decisions taken by notified bodies is available. (56) In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to subsystems and safety components covered by this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks. (57) Directive 2000/9/EC already provides for a safeguard procedure which is necessary to allow for the possibility of contesting the conformity of a subsystem or safety component. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States. (58) The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to subsystems and safety components presenting a risk to the health or safety of persons or to property. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such subsystems and safety components. (59) Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard. (60) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (9). (61) The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification. (62) The examination procedure should be used for the adoption of implementing acts with respect to compliant subsystems and safety components which present a risk to the health or safety of persons or to property. (63) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant subsystems or safety components which present a risk to the health or safety of persons, imperative grounds of urgency so require. (64) In line with established practice, the committee set up by this Regulation can play a useful role in examining matters concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure. (65) When matters relating to this Regulation, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and, where appropriate, an invitation to attend such meetings. (66) The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant subsystems or safety components are justified or not. (67) It is necessary to provide for reasonable transitional arrangements that allow the making available on the market, without the need to comply with further product requirements, of subsystems and safety components that have already been placed on the market in accordance with Directive 2000/9/EC. (68) It is necessary to provide for transitional arrangements that allow the entry into service of cableway installations that have already been installed in accordance with Directive 2000/9/EC. (69) Member States should lay down rules on penalties applicable to infringements of this Regulation and of national law adopted pursuant to this Regulation and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive. The penalties should have regard to the seriousness, the duration and, where applicable, the intentional character of the infringement. In addition, the penalties should have regard to whether the relevant economic operator has previously committed a similar infringement of this Regulation. (70) Since the objective of this Regulation, namely to ensure that cableway installations fulfil the requirements providing for a high level of protection of health and safety of persons and of property while guaranteeing the functioning of the internal market for subsystems and safety components, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (71) Directive 2000/9/EC should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down rules on the making available on the market and the free movement of subsystems and safety components for cableway installations. It also contains rules on the design, construction and entry into service of new cableway installations. Article 2 Scope 1. This Regulation applies to new cableway installations designed to transport persons, to modifications of cableway installations requiring a new authorisation, and to subsystems and safety components for cableway installations. 2. This Regulation does not apply to the following: (a) lifts covered by Directive 2014/33/EU; (b) cableway installations that are categorised by Member States as historic, cultural or heritage installations, that entered into service before 1 January 1986 and that are still in operation, and that have not had any significant changes in design or construction, including subsystems and safety components specifically designed for them; (c) installations intended for agricultural or forestry purposes; (d) cableway installations for the service of mountain shelters and huts intended only for the transport of goods and specifically designated persons; (e) on-site or mobile equipment exclusively designed for leisure and amusement purposes and not as a means for transporting persons; (f) mining installations or other industrial on-site installations used for industrial activities; (g) installations in which the users or their carriers are waterborne. Article 3 Definitions For the purposes of this Regulation the following definitions apply: (1) \u2018cableway installation\u2019 means a whole on-site system, consisting of infrastructure and subsystems, which is designed, constructed, assembled and put into service with the objective of transporting persons, where the traction is provided by cables positioned along the line of travel; (2) \u2018subsystem\u2019 means a system listed in Annex I, or a combination thereof, intended to be incorporated into a cableway installation; (3) \u2018infrastructure\u2019 means a station structure or a structure along the line specifically designed for each cableway installation and constructed on-site, which takes into account the layout and the data of the system and which is needed for the construction and the operation of the cableway installation, including the foundations; (4) \u2018safety component\u2019 means any component of equipment or any device intended to be incorporated into a subsystem or a cableway installation for the purpose of ensuring a safety function, the failure of which endangers the safety or health of passengers, operating personnel or third parties; (5) \u2018operability\u2019 means all the technical provisions and measures which have an impact on design and construction and are necessary in order for the cableway installation to operate safely; (6) \u2018maintainability\u2019 means all the technical provisions and measures which have an impact on design and construction and are necessary for maintenance, having been designed to ensure that the cableway installation operates safely; (7) \u2018cable car\u2019 means a cableway installation where the carriers are suspended from and propelled by one or more cables; (8) \u2018drag lift\u2019 means a cableway installation where passengers with appropriate equipment are towed along a prepared track; (9) \u2018funicular railway\u2019 means a cableway installation in which the carriers are hauled by one or more ropes along a track that may lie on the ground or be supported by fixed structures; (10) \u2018making available on the market\u2019 means any supply of a subsystem or a safety component for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (11) \u2018placing on the market\u2019 means the first making available of a subsystem or a safety component on the Union market; (12) \u2018entry into service\u2019 means the initial operation of a cableway installation with the explicit object of transporting persons; (13) \u2018manufacturer\u2019 means any natural or legal person who manufactures a subsystem or a safety component or who has such a subsystem or a safety component designed or manufactured, and markets that subsystem or safety component under his name or trade mark or incorporates it into a cableway installation; (14) \u2018authorised representative\u2019 means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; (15) \u2018importer\u2019 means any natural or legal person established within the Union who places a subsystem or a safety component from a third country on the Union market; (16) \u2018distributor\u2019 means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a subsystem or a safety component available on the market; (17) \u2018economic operators\u2019 means the manufacturer, the authorised representative, the importer and the distributor of a subsystem or a safety component; (18) \u2018technical specification\u2019 means a document that prescribes technical requirements to be fulfilled by a cableway installation, infrastructure, subsystem or safety component; (19) \u2018harmonised standard\u2019 means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012; (20) \u2018accreditation\u2019 means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008; (21) \u2018national accreditation body\u2019 means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008; (22) \u2018conformity assessment\u2019 means the process demonstrating whether the essential requirements of this Regulation relating to a subsystem or safety component have been fulfilled; (23) \u2018conformity assessment body\u2019 means a body that performs conformity assessment activities relating to a subsystem or safety component, including calibration, testing, certification and inspection; (24) \u2018recall\u2019 means any measure aimed at achieving the return of a subsystem or a safety component that has already been made available to the person responsible for the cableway installation; (25) \u2018withdrawal\u2019 means any measure aimed at preventing a subsystem or a safety component in the supply chain from being made available on the market; (26) \u2018Union harmonisation legislation\u2019 means any Union legislation harmonising the conditions for the marketing of products; (27) \u2018CE marking\u2019 means a marking by which the manufacturer indicates that the subsystem or the safety component is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing. Article 4 Making available on the market of subsystems and safety components Subsystems and safety components shall only be made available on the market if they comply with this Regulation. Article 5 Entry into service of cableway installations 1. Member States shall, in accordance with Article 9, take all appropriate measures to determine the procedures for ensuring that cableway installations enter into service only if they comply with this Regulation and are not liable to endanger the health or safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose. 2. Member States shall, in accordance with Article 9, take all appropriate measures to determine the procedures for ensuring that the subsystems and safety components are incorporated into cableway installations only if they enable the construction of cableway installations which comply with this Regulation and are not liable to endanger the health or safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose. 3. Cableway installations which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards or parts thereof. 4. This Regulation shall not affect Member States' entitlement to lay down such requirements as they may deem necessary to ensure that persons and, in particular, workers are protected when using the cableway installations in question, provided that this does not mean that the cableway installations are modified in a manner not covered by this Regulation. Article 6 Essential requirements The cableway installations and their infrastructure, subsystems and safety components shall meet the essential requirements set out in Annex II which apply to them. Article 7 Free movement of subsystems and safety components Member States shall not prohibit, restrict or impede the making available on the market of subsystems and safety components which comply with this Regulation. Article 8 Safety analysis and safety report for planned cableway installations 1. The person responsible for the cableway installation, determined by a Member State in accordance with national law, shall carry out a safety analysis of the planned cableway installation or have such a safety analysis carried out. 2. The safety analysis required for each cableway installation shall: (a) take into account all modes of operation envisaged; (b) follow a recognised or established method; (c) take into account the current state of the art and the complexity of the cableway installation in question; (d) ensure that the design and configuration of the cableway installation takes account of the local surroundings and the most adverse situations in order to ensure satisfactory safety conditions; (e) cover all safety aspects of the cableway installation and its external factors in the context of the design, construction and entry into service; (f) make it possible to identify from past experience risks liable to occur during the operation of the cableway installation. 3. The safety analysis shall also cover the safety devices and their effects on the cableway installation and related subsystems that they bring into action so that the safety devices: (a) are capable of reacting to an initial breakdown or failure detected so as to remain either in a state that guarantees safety, in a lower operating mode or in a fail-safe state; (b) are redundant and are monitored; or (c) are such that the probability of their failure can be evaluated and their effects are of a standard equivalent to that achieved by safety devices that meet the criteria set out in points (a) and (b). 4. The safety analysis shall be used to draw up the inventory of risks and dangerous situations, to recommend the measures envisaged to deal with such risks and to determine the list of subsystems and safety components to be incorporated into the cableway installation. 5. The result of the safety analysis shall be included in a safety report. Article 9 Authorisation of cableway installations 1. Each Member State shall lay down procedures for authorising the construction and the entry into service of cableway installations which are located within its territory. 2. The person responsible for the cableway installation, determined by a Member State in accordance with national law, shall submit the safety report referred to in Article 8, the EU declaration of conformity and the other documents relating to the conformity of subsystems and safety components as well as the documentation concerning the characteristics of the cableway installation to the authority or body responsible for authorising the cableway installation. The documentation concerning the cableway installation shall also include the necessary conditions, including the restrictions on operation, and full details for servicing, supervision, adjustment and maintenance of the cableway installation. A copy of those documents shall be kept at the cableway installation. 3. In the event that important characteristics, subsystems or safety components of existing cableway installations undergo modifications for which a new authorisation for entry into service is required by the Member State concerned, such modifications and their repercussions on the cableway installation as a whole shall satisfy the essential requirements set out in Annex II. 4. Member States shall not use the procedures referred to in paragraph 1 to prohibit, restrict or hinder, on grounds related to the aspects covered by this Regulation, the construction and the entry into service of cableway installations which comply with this Regulation and do not present a risk to the health or safety of persons or to property when properly installed in accordance with their intended purpose. 5. Member States shall not use the procedures referred to in paragraph 1 to prohibit, restrict or hinder the free movement of subsystems and safety components which comply with this Regulation. Article 10 Operation of cableway installations 1. Member States shall ensure that a cableway installation remains in operation only if it complies with the conditions set out in the safety report. 2. Where a Member State finds that an authorised cableway installation which is used in accordance with its intended purpose is liable to endanger the health or safety of persons or property, it shall take all appropriate measures to restrict the conditions of operation of the cableway installation or to prohibit the operation thereof. CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS Article 11 Obligations of manufacturers 1. When placing their subsystems or safety components on the market or when incorporating them into a cableway installation, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex II. 2. Manufacturers of subsystems or safety components shall draw up the technical documentation set out in Annex VIII (\u2018technical documentation\u2019) and carry out the relevant conformity assessment procedure referred to in Article 18 or have it carried out. Where compliance of a subsystem or a safety component with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking. 3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 30 years after the subsystem or the safety component has been placed on the market. 4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in subsystem or safety component design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the subsystem or the safety component is declared shall be adequately taken into account. When deemed appropriate with regard to the risks presented by a subsystem or a safety component, manufacturers shall, to protect the health and safety of passengers, operating personnel and third parties, carry out sample testing of subsystems or safety components made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming subsystems and safety components and recalls of such subsystems and safety components, and shall keep distributors informed of any such monitoring. 5. Manufacturers shall ensure that subsystems or safety components which they have placed on the market bear a type, batch or serial number or other element allowing their identification. Where the size or nature of the subsystem or safety component does not allow it, manufacturers shall ensure that the required information is provided on the packaging or in a document accompanying the subsystem or safety component. 6. Manufacturers shall indicate on the subsystem or the safety component their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a document accompanying the subsystem or safety component. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by users and the market surveillance authorities. Where the manufacturer indicates a website address, he shall ensure that the information on that website is accessible and kept updated. 7. Manufacturers shall ensure that the subsystem or the safety component is accompanied by a copy of the EU declaration of conformity and by instructions and safety information, in a language which can be easily understood by users, as determined by the Member State concerned. Such instructions and safety information shall be clear, understandable and intelligible. However, where a large number of subsystems or safety components are delivered to a single economic operator or user, the batch or consignment concerned may be accompanied by a single copy of the EU declaration of conformity. 8. Manufacturers who consider or have reason to believe that a subsystem or a safety component which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that subsystem or safety component into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the subsystem or the safety component presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the subsystem or the safety component available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the subsystem or the safety component with this Regulation, in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by subsystems or safety components which they have placed on the market. Article 12 Authorised representatives 1. A manufacturer may, by a written mandate, appoint an authorised representative. The obligations laid down in Article 11(1) and the obligation to draw up technical documentation shall not form part of the authorised representative's mandate. 2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following: (a) keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 30 years after the subsystem or the safety component has been placed on the market; (b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the subsystem or the safety component; (c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by subsystems or safety components covered by the authorised representative's mandate. Article 13 Obligations of importers 1. Importers shall place only compliant subsystems or safety components on the market. 2. Before placing on the market a subsystem or a safety component, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 18 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the subsystem or the safety component bears the CE marking and that it is accompanied by a copy of the EU declaration of conformity, by instructions and safety information, and, where appropriate, by other required documents, and that the manufacturer has complied with the requirements set out in Article 11(5) and (6). Where an importer considers or has reason to believe that a subsystem or a safety component is not in conformity with the applicable essential requirements set out in Annex II, he shall not place the subsystem or the safety component on the market until it has been brought into conformity. Furthermore, where the subsystem or the safety component presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect. 3. Importers shall indicate on the subsystem or the safety component their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the subsystem or safety component. The contact details shall be in a language easily understood by users and market surveillance authorities. Where the importer indicates a website address, he shall ensure that the information on that website is accessible and kept updated. 4. Importers shall ensure that the subsystem or the safety component is accompanied by instructions and safety information, in a language which can be easily understood by users, as determined by the Member State concerned. 5. Importers shall ensure that, while a subsystem or a safety component is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable essential requirements set out in Annex II. 6. When deemed appropriate with regard to the risks presented by a subsystem or a safety component, importers shall, to protect the health and safety of the passengers, operating personnel and third parties, carry out sample testing of subsystems or safety components made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming subsystems and safety components and recalls of such subsystems and safety components, and shall keep distributors informed of any such monitoring. 7. Importers who consider or have reason to believe that a subsystem or a safety component which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that subsystem or safety component into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the subsystem or the safety component presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the subsystem or the safety component available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 8. Importers shall, for 30 years after the subsystem or the safety component has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request. 9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a subsystem or a safety component, in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by subsystems or safety components which they have placed on the market. Article 14 Obligations of distributors 1. When making a subsystem or a safety component available on the market, distributors shall act with due care in relation to the requirements of this Regulation. 2. Before making a subsystem or a safety component available on the market, distributors shall verify that the subsystem or the safety component bears the CE marking and that it is accompanied by a copy of the EU declaration of conformity, by instructions and safety information, and, where appropriate, by other required documents, in a language which can be easily understood by users as determined by the Member State concerned, and that the manufacturer and the importer have complied with the requirements set out in Article 11(5) and (6) and Article 13(3) respectively. Where a distributor considers or has reason to believe that a subsystem or a safety component is not in conformity with the applicable essential requirements set out in Annex II, he shall not make the subsystem or the safety component available on the market until it has been brought into conformity. Furthermore, where the subsystem or the safety component presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities. 3. Distributors shall ensure that, while a subsystem or a safety component is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable essential requirements set out in Annex II. 4. Distributors who consider or have reason to believe that a subsystem or a safety component which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring that subsystem or safety component into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the subsystem or the safety component presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the subsystem or the safety component available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 5. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a subsystem or a safety component. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by subsystems or safety components which they have made available on the market. Article 15 Cases in which obligations of manufacturers apply to importers and distributors An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 11, where he places a subsystem or a safety component on the market under his name or trade mark or modifies a subsystem or a safety component already placed on the market in such a way that compliance with the requirements of this Regulation may be affected. Article 16 Identification of economic operators Economic operators shall, on request, identify the following to the market surveillance authorities: (a) any economic operator who has supplied them with a subsystem or a safety component; (b) any economic operator and any person responsible for a cableway installation to whom they have supplied a subsystem or a safety component. Economic operators shall be able to present the information referred to in the first paragraph for 30 years after they have been supplied with the subsystem or the safety component and for 30 years after they have supplied the subsystem or the safety component. CHAPTER III CONFORMITY OF SUBSYSTEMS AND SAFETY COMPONENTS Article 17 Presumption of conformity of subsystems and safety components Subsystems and safety components which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards or parts thereof. Article 18 Conformity assessment procedures 1. Before a subsystem or a safety component is placed on the market, the manufacturer shall submit the subsystem or the safety component to a conformity assessment procedure in accordance with paragraph 2. 2. The conformity of subsystems and safety components shall be assessed, at the choice of the manufacturer, by means of any of the following conformity assessment procedures: (a) EU-type examination (Module B \u2014 production type), set out in Annex III combined with one of the following: (i) conformity to type based on quality assurance of the production process (Module D), set out in Annex IV; (ii) conformity to type based on subsystem or safety component verification (Module F), set out in Annex V; (b) conformity based on unit verification (Module G), set out in Annex VI; (c) conformity based on full quality assurance plus design examination (Module H 1), set out in Annex VII. 3. Records and correspondence relating to the conformity assessment procedures shall be drawn up in an official language of the Member State where the notified body carrying out the procedures referred to in paragraph 2 is established or in a language accepted by that body. Article 19 EU declaration of conformity 1. The EU declaration of conformity for a subsystem or a safety component shall state that the fulfilment of the essential requirements set out in Annex II has been demonstrated. 2. The EU declaration of conformity shall have the model structure set out in Annex IX, shall contain the elements specified in the relevant modules set out in Annexes III to VII and shall be continuously updated. It shall accompany the subsystem or the safety component and shall be translated into the language or languages required by the Member State in which the subsystem or the safety component is placed or made available on the market. 3. Where a subsystem or a safety component is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references. 4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the subsystem or the safety component with the requirements laid down in this Regulation. Article 20 General principles of the CE marking The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. Article 21 Rules and conditions for affixing the CE marking 1. The CE marking shall be affixed visibly, legibly and indelibly to the subsystem or the safety component or to its data plate. Where that is not possible or not warranted on account of the nature of the subsystem or the safety component, it shall be affixed to the packaging and to the accompanying documents. 2. The CE marking shall be affixed before the subsystem or the safety component is placed on the market. 3. The CE marking shall be followed by the identification number of the notified body involved in the production control phase. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative. 4. The CE marking and the identification number referred to in paragraph 3 may be followed by any other mark indicating a special risk or use. 5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. CHAPTER IV NOTIFICATION OF CONFORMITY ASSESSMENT BODIES Article 22 Notification Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation. Article 23 Notifying authorities 1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 28. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008. 3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 24. In addition, it shall have arrangements to cover liabilities arising out of its activities. 4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3. Article 24 Requirements relating to notifying authorities 1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs. 2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities. 3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment. 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis. 5. A notifying authority shall safeguard the confidentiality of the information it obtains. 6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks. Article 25 Information obligation on notifying authorities Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available. Article 26 Requirements relating to notified bodies 1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. 2. A conformity assessment body shall be established under the national law of a Member State and have legal personality. 3. A conformity assessment body shall be a third-party body independent of the organisation or the subsystem or the safety component it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of subsystems or safety components which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. 4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the subsystems or the safety components which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed subsystems or safety components that are necessary for the operations of the conformity assessment body or the use of such subsystems or safety components for personal purposes. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of those subsystems or safety components, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services. Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. 5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. 6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes III to VII and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. At all times, and for each conformity assessment procedure and each kind or category of subsystems or safety components in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary: (a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities; (c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the subsystem or safety component technology in question and the mass or serial nature of the production process. A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. 7. The personnel responsible for carrying out conformity assessment tasks shall have the following: (a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; (b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding of the essential requirements set out in Annex II, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of national legislation; (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. 8. The impartiality of the conformity assessment bodies, their top-level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed. The remuneration of the top-level management and of the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out, nor on the results of those assessments. 9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment. 10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III to VII or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected. 11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under this Regulation, and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group. Article 27 Presumption of conformity of notified bodies Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 26 in so far as the applicable harmonised standards cover those requirements. Article 28 Subsidiaries of and subcontracting by notified bodies 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 26 and shall inform the notifying authority accordingly. 2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established. 3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. 4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III to VII. Article 29 Application for notification 1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the subsystem/safety component or subsystems/safety components for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 26. 3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 26. Article 30 Notification procedure 1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 26. 2. They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission. 3. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the subsystem/safety component or subsystems/safety components concerned and the relevant attestation of competence. 4. Where a notification is not based on an accreditation certificate as referred to in Article 29(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 26. 5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used. Only such a body shall be considered a notified body for the purposes of this Regulation. 6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification. Article 31 Identification numbers and lists of notified bodies 1. The Commission shall assign an identification number to a notified body. It shall assign a single such number even where the body is notified under several Union acts. 2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date. Article 32 Changes to notifications 1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 26 or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. 2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request. Article 33 Challenge of the competence of notified bodies 1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject. 2. The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned. 3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 44(2). Article 34 Operational obligations of notified bodies 1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII. 2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the subsystem or safety component technology in question and the mass or serial nature of the production process. In so doing, they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the subsystem or the safety component with this Regulation. 3. Where a notified body finds that the essential requirements set out in Annex II or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision. 4. Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, a notified body finds that a subsystem or a safety component no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision if necessary. 5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate. Article 35 Appeal against decisions of notified bodies Notified bodies shall ensure that an appeal procedure against their decisions is available. Article 36 Information obligation on notified bodies 1. Notified bodies shall inform the notifying authority of the following: (a) any refusal, restriction, suspension or withdrawal of a certificate or approval decision; (b) any circumstances affecting the scope of or the conditions for notification; (c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities; (d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting. 2. Notified bodies shall provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same subsystems or safety components with relevant information on issues relating to negative and, on request, positive conformity assessment results. Article 37 Exchange of experience The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy. Article 38 Coordination of notified bodies The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of the coordination group of notified bodies for cableway installations. Notified bodies shall participate in the work of that group, directly or by means of designated representatives. CHAPTER V UNION MARKET SURVEILLANCE, CONTROL OF SUBSYSTEMS AND SAFETY COMPONENTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE Article 39 Union market surveillance and control of subsystems and safety components entering the Union market Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to subsystems and safety components. Article 40 Procedure at national level for dealing with subsystems or safety components presenting a risk 1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a subsystem or safety component covered by this Regulation presents a risk to the health or safety of persons or to property, they shall carry out an evaluation in relation to the subsystem or safety component concerned, covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose. Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the subsystem or safety component does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the subsystem or safety component into compliance with those requirements, to withdraw the subsystem or safety component from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe. The market surveillance authorities shall inform the relevant notified body accordingly. Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph. 2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take. 3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the subsystems and safety components concerned that he has made available on the market throughout the Union. 4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the subsystem or safety component being made available on their national market, to withdraw the subsystem or safety component from that market or to recall it. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. 5. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant subsystem or safety component, the origin of the subsystem or safety component, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following: (a) failure of the subsystem or safety component to meet requirements relating to the health or safety of persons or the protection of property; or (b) shortcomings in the harmonised standards referred to in Article 17 conferring a presumption of conformity. 6. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the subsystem or safety component concerned, and, in the event of disagreement with the adopted national measure, of their objections. 7. Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. 8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the subsystem or safety component from the market, are taken in respect of the subsystem or safety component concerned without delay. Article 41 Union safeguard procedure 1. Where, on completion of the procedure set out in Article 40(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. 2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant subsystem or safety component is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure. 3. Where the national measure is considered justified and the non-compliance of the subsystem or safety component is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 40(5) of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012. Article 42 Compliant subsystems or safety components which present a risk 1. Where, having carried out an evaluation under Article 40(1), a Member State finds that although a subsystem or safety component is in compliance with this Regulation, it presents a risk to the health or safety of persons or to property, it shall require the relevant economic operator to take all appropriate measures to ensure that the subsystem or safety component concerned, when placed on the market, no longer presents that risk, to withdraw the subsystem or safety component from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe. 2. The economic operator shall ensure that corrective action is taken in respect of all the subsystems or safety components concerned that he has made available on the market throughout the Union. 3. The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the subsystem or safety component concerned, the origin and the supply chain of the subsystem or safety component, the nature of the risk involved and the nature and duration of the national measures taken. 4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide by means of implementing acts whether the national measure is justified or not and, where necessary, propose appropriate measures. The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 44(3). On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 44(4). 5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. Article 43 Formal non-compliance 1. Without prejudice to Article 40, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 21 of this Regulation; (b) the CE marking has not been affixed; (c) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 21 or has not been affixed; (d) the EU declaration of conformity does not accompany the subsystem or safety component; (e) the EU declaration of conformity has not been drawn up; (f) the EU declaration of conformity has not been drawn up correctly; (g) the technical documentation is either not available or not complete; (h) the information referred to in Article 11(6) or Article 13(3) is absent, false or incomplete; (i) any other administrative requirement provided for in Article 11 or Article 13 is not fulfilled. 2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the subsystem or safety component being made available on the market, or ensure that it is recalled or withdrawn from the market. CHAPTER VI COMMITTEE PROCEDURE, TRANSITIONAL AND FINAL PROVISIONS Article 44 Committee procedure 1. The Commission shall be assisted by the Committee on cableway installations. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. 5. The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by any other Union legislation. The committee may furthermore examine any other matter concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure. Article 45 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements by economic operators of the provisions of this Regulation and of national law adopted pursuant to this Regulation. Such rules may include criminal penalties for serious infringements. The penalties provided for shall be effective, proportionate and dissuasive and may be increased where the relevant economic operator has previously committed a similar infringement of this Regulation. Member States shall notify those rules to the Commission by 21 March 2018, and shall notify it without delay of any subsequent amendment affecting them. 2. Member States shall take all measures necessary to ensure that their rules on penalties applicable to infringements by economic operators of the provisions of this Regulation are enforced. Article 46 Transitional provisions Member States shall not impede the making available on the market of subsystems or safety components covered by Directive 2000/9/EC which are in conformity with that Directive and which were placed on the market before 21 April 2018. Member States shall not impede the entry into service of cableway installations covered by Directive 2000/9/EC which are in conformity with that Directive and which were installed before 21 April 2018. For safety components, certificates and approval decisions issued under Directive 2000/9/EC shall be valid under this Regulation. Article 47 Repeal Directive 2000/9/EC is repealed with effect from 21 April 2018. References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex X. Article 48 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. This Regulation shall apply from 21 April 2018, with the exception of: (a) Articles 22 to 38 and 44, which shall apply from 21 October 2016; (b) Article 45(1), which shall apply from 21 March 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 March 2016. For the European Parliament The President M. SCHULZ For the Council The President J.A. HENNIS-PLASSCHAERT (1) OJ C 451, 16.12.2014, p. 81. (2) Position of the European Parliament of 20 January 2016 (not yet published in the Official Journal) and decision of the Council of 12 February 2016. (3) Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2000 relating to cableway installations designed to carry persons (OJ L 106, 3.5.2000, p. 21). (4) OJ C 136, 4.6.1985, p. 1. (5) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European Standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (6) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). (7) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (8) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251). (9) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). ANNEX I SUBSYSTEMS A cableway installation is divided up into infrastructure and the subsystems listed below: 1. Cables and cable connections. 2. Drives and brakes. 3. Mechanical equipment: 3.1. Cable winding gear. 3.2. Station machinery. 3.3. Line engineering. 4. Vehicles: 4.1. Cabins, seats or drag devices. 4.2. Suspension gear. 4.3. Driving gear. 4.4. Connections to the cable. 5. Electrotechnical devices: 5.1. Monitoring, control and safety devices. 5.2. Communication and information equipment. 5.3. Lightning protection equipment. 6. Rescue equipment: 6.1. Fixed rescue equipment. 6.2. Mobile rescue equipment. ANNEX II ESSENTIAL REQUIREMENTS 1. Purpose This Annex sets out the essential requirements, including maintainability and operability, applicable to the design, construction and entry into service of cableway installations, and applicable to subsystems and safety components. 2. General requirements 2.1. Safety of persons The safety of passengers, operating personnel and third parties is a fundamental requirement for the design, construction and operation of cableway installations. 2.2. Principles of safety All cableway installations shall be designed, operated and serviced in accordance with the following principles, which are to be applied in the order given: \u2014 eliminate or, if that is not possible, reduce risks by means of design and construction features, \u2014 define and implement all necessary measures to protect against risks which cannot be eliminated by the design and construction features, \u2014 define and state the precautions which should be taken to avoid the risks which it has not been possible to eliminate completely by means of the provisions and measures referred to in the first and second indents. 2.3. Consideration of external factors Cableway installations must be so designed and constructed as to make it possible to operate them safely, taking into account the type of cableway installation, the nature and physical features of the terrain on which it is installed, its surroundings and atmospheric and meteorological factors, as well as possible structures and obstacles located in the vicinity either on the ground or in the air. 2.4. Dimensions The cableway installation, the subsystems and all its safety components shall be dimensioned, designed and constructed to withstand, with a sufficient degree of safety, all stresses encountered under all foreseeable conditions, including those which occur when not in operation, and taking account in particular of outside influences, dynamic effects and fatigue phenomena, while complying with the acknowledged rules of the art, in particular with regard to the choice of materials. 2.5. Assembly 2.5.1. The cableway installation, the subsystems and all the safety components shall be designed and constructed in such a way as to ensure that they can be safely assembled and put into place. 2.5.2. The safety components shall be so designed as to make assembly mistakes impossible, either as a result of construction or by means of appropriate markings on the components themselves. 2.6. Integrity of the cableway installation 2.6.1. The safety components shall be designed and constructed and be usable in such a way as to ensure that, in every case, their own operational integrity and/or the safety of the cableway installation is ensured, as defined in the safety analysis provided for in Article 8, so that their failure is highly improbable and with an adequate safety margin. 2.6.2. The cableway installation shall be designed and constructed in such a way as to ensure that, during its operation, any failure of a component which might endanger safety, is met by an appropriate measure being taken in good time. 2.6.3. The safeguards referred to in points 2.6.1 and 2.6.2 shall apply throughout the period between two scheduled inspections of the component concerned. The time period for the scheduled inspection of the safety components shall be clearly indicated in the instruction manual. 2.6.4. Safety components which are incorporated into cableway installations as spare parts shall satisfy the essential requirements of this Regulation and the conditions relating to the smooth interaction with the other parts of the cableway installations. 2.6.5. Measures shall be taken to ensure that the effects of a fire in the cableway installation do not endanger the safety of persons. 2.6.6. Special measures shall be taken to protect cableway installations and persons from the effects of lightning. 2.7. Safety devices 2.7.1. Any defect in the cableway installation which could result in a failure endangering safety shall, where practicable, be detected, reported and processed by a safety device. The same applies to any normally foreseeable external event which may endanger safety. 2.7.2. It shall be possible at all times to shut down the cableway installation manually. 2.7.3. After the cableway installation has been shut down by a safety device, it shall not be possible to restart it unless appropriate action has been taken. 2.8. Maintainability The cableway installation shall be designed and constructed so as to enable routine or special maintenance and repair operations and procedures to be carried out safely. 2.9. Nuisance The cableway installation shall be designed and constructed in such a way as to ensure that any internal or external nuisance resulting from noxious gases, noise emissions or vibrations falls within the prescribed limits. 3. Infrastructure requirements 3.1. Layout, speed, distance between vehicles 3.1.1. The cableway installation shall be designed to operate safely taking into account the characteristics of the terrain and its surroundings, atmospheric and meteorological conditions, any possible structures and obstacles located in the vicinity either on the ground or in the air in such a way as to cause no nuisance or pose no danger under any operational or servicing conditions or in the event of an operation to rescue persons. 3.1.2. Sufficient distance shall be maintained laterally and vertically between vehicles, towing devices, tracks, cables, etc., and possible structures and obstacles located in the vicinity either on the ground or in the air, taking account of the vertical, longitudinal and lateral movement of the cables and vehicles or of the towing devices under the most adverse foreseeable operating conditions. 3.1.3. The maximum distance between vehicles and ground shall take account of the nature of the cableway installation, the type of vehicles and the rescue procedures. In the case of open cars it shall also take account of the risk of fall as well as the psychological aspects associated with the distance between vehicles and ground. 3.1.4. The maximum speed of the vehicles or towing devices, the minimum distance between them and their acceleration and braking performance shall be chosen to ensure the safety of persons and the safe operation of the cableway installation. 3.2. Stations and structures along the line 3.2.1. Stations and structures along the line shall be designed, installed and equipped so as to ensure stability. They shall permit safe guidance of the cables, vehicles and the towing devices, and enable maintenance to be safely carried out, under all operating conditions. 3.2.2. The entry and exit areas of the cableway installation shall be designed so as to guarantee the safety of the traffic of vehicles, towing devices and persons. The movement of vehicles and towing devices in the stations shall be capable of taking place without risk to persons, taking into account their possible active collaboration to their movement. 4. Requirements relating to cables, drives and brakes and to mechanical and electrical installations 4.1. Cables and their supports 4.1.1. All measures shall be taken in line with the latest technological developments: \u2014 to avoid cables or their attachments breaking, \u2014 to cover their minimum and maximum stress values, \u2014 to ensure that they are safely mounted on their supports and prevent derailment, \u2014 to enable them to be monitored. 4.1.2. It is not possible to prevent all risk of cable derailment; measures shall be taken to ensure that cables can be retrieved and the cableway installations shut down without risk to persons in the event of derailment. 4.2. Mechanical installations 4.2.1. Drives The drive system of a cableway installation shall be of a suitable performance and capability, adapted to the various operating systems and modes. 4.2.2. Standby drive The cableway installation shall have a standby drive with an energy supply which is independent of that of the main drive system. A standby drive is not, however, necessary if the safety analysis shows that people can leave the vehicles and, in particular, towing devices easily, quickly and safely even if a standby drive is not available. 4.2.3. Braking 4.2.3.1. In an emergency, it shall be possible to shut down the cableway installation and/or the vehicles at any moment, under the most unfavourable conditions in terms of authorised load and pulley adhesion during operation. The stopping distance shall be as short as the security of the cableway installation dictates. 4.2.3.2. Deceleration values shall be within adequate limits fixed in such a way as to ensure both the safety of the persons and the satisfactory behaviour of the vehicles, cables and other parts of the cableway installation. 4.2.3.3. In all cableway installations there shall be two or more braking systems, each capable of bringing the cableway installation to a halt, and coordinated in such a way that they automatically replace the active system when its efficiency becomes inadequate. The cableway installation's last braking system shall act as close as possible to the traction cable. These provisions do not apply to drag lifts. 4.2.3.4. The cableway installation shall be fitted with an effective clamp and locking mechanism to guard against premature restarts. 4.3. Control devices The control devices shall be designed and constructed so as to be safe and reliable, to withstand normal operating stresses and external factors such as humidity, extreme temperatures or electromagnetic interference and so as not to cause dangerous situations, even in the event of operational error. 4.4. Communication devices Suitable facilities shall be provided to enable operational staff to communicate with one another at all times and to inform passengers in case of emergency. 5. Vehicles and towing devices 5.1. Vehicles and/or towing devices shall be designed and fitted out in such a way that under foreseeable operating conditions no passenger or operating personnel can fall out or encounter any other risks. 5.2. The fittings of vehicles and towing devices shall be dimensioned and constructed so as not to: \u2014 damage the cable, or \u2014 slip, except where slippage does not significantly affect the safety of the vehicle, the towing device or the installation, under the most unfavourable conditions. 5.3. Vehicle doors (on cars, cabins) shall be designed and constructed in such a way as to make it possible to close and lock them. The vehicle floor and walls shall be designed and constructed so as to withstand pressure and loads exerted by passengers and operating personnel under any circumstances. 5.4. If, for reasons of operational safety, an operator is required on board the vehicle, the vehicle shall be fitted with the equipment required for him to carry out his tasks. 5.5. Vehicles and/or towing devices and, in particular, their suspension mechanisms shall be designed and fitted so as to ensure the safety of workers servicing them in accordance with appropriate rules and instructions. 5.6. In the case of vehicles equipped with disconnectable fittings, all measures shall be taken to bring to a halt, without risk to passengers or operating personnel, at the moment of departure, any vehicle whose fitting has been incorrectly connected to the cable and, at the moment of arrival, any vehicle whose fitting has not been disconnected, and to prevent the vehicle from falling. 5.7. The installations which have their vehicles running on a fixed track (such as funicular vehicles and multi-rope cable cars) shall be equipped with an automatic braking device on the track, when the possibility of traction cable breaking cannot reasonably be excluded. 5.8. Where all risk of derailment of the vehicle cannot be eliminated by other measures, the vehicle shall be fitted with an anti-derailment device which enables the vehicle to be brought to a halt without risk to persons. 6. Equipment for passengers and operating personnel The access to embarkation areas and exit from disembarkation areas and the embarkation and disembarkation of passengers and operating personnel shall be organised with regard to the movement and stopping of vehicles in such a way as to ensure the safety of passengers and operating personnel, in particular in areas where there is a risk of falling. It must be possible for children and persons with reduced mobility to use the cableway installation safely if the cableway installation is designed for the transport of such persons. 7. Operability 7.1. Safety 7.1.1. All technical provisions and measures shall be taken to ensure that the cableway installation is used for its intended purpose according to its technical specification and to the specified operating conditions and that the instructions on safe operation and maintenance can be complied with. The instruction manual and the corresponding notes shall be drawn up in a language which can be easily understood by users, as determined by the Member State in the territory of which the cableway installation is constructed. 7.1.2. The persons responsible for operating the cableway installation shall be provided with the appropriate material resources and shall be qualified to carry out the task in hand. 7.2. Safety in the event of immobilisation of the cableway installation All technical provisions and measures shall be adopted to ensure that passengers and operating personnel can be brought to safety within a set time appropriate to the type of cableway installation and its surroundings when the cableway installation is immobilised and cannot be restarted quickly. 7.3. Other special provisions concerning safety 7.3.1. Operators' stands and workplaces Movable parts which are normally accessible in the stations shall be designed, constructed and installed in such a way as to preclude any risks or, where such risks exist, be fitted with protective devices so as to prevent any contact with parts of the cableway installation which may cause accidents. Those devices shall be of a type that cannot easily be removed or rendered inoperative. 7.3.2. Risk of falling Workplaces and working areas, including those used only occasionally, and the access to them, shall be designed and constructed in such a way as to prevent persons required to work or move in them from falling. Should the construction not be adequate, they shall also be provided with anchorage points for personal protective equipment to prevent falls. ANNEX III CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE B: EU-TYPE EXAMINATION \u2014 PRODUCTION TYPE 1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a subsystem or a safety component and verifies and attests that the technical design meets the requirements of this Regulation that apply to it. 2. EU-type examination shall be carried out by assessment of the adequacy of the technical design of the subsystem or the safety component through examination of the technical documentation referred to in point 3, plus examination of a specimen, representative of the production envisaged, of the complete subsystem or safety component (production type). 3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) the technical documentation for the subsystem or the safety component according to Annex VIII; (d) a representative specimen of the subsystem or the safety component envisaged or details of the premises where it can be examined. The notified body may request further specimens if needed for carrying out the test programme. 4. The notified body shall: 4.1. examine the technical documentation to assess the adequacy of the technical design of the subsystem or the safety component; 4.2. verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements that have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications; 4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly; 4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Regulation; 4.5. agree with the manufacturer on a location where the examinations and tests will be carried out. 5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-\u00e0-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. 6. Where the type meets the requirements of this Regulation, the notified body shall issue an EU-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, any conditions for its validity, the necessary data for identification of the approved type (subsystem or safety component) and if relevant, descriptions of its functioning. The certificate may have one or more annexes attached. The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems and safety components with the examined type to be evaluated and to allow for in-service control. It shall also indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved type. The certificate shall have a maximum validity period of 30 years from the date of its issue. Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Regulation and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of any modifications to the approved type that may affect the conformity of the subsystem or the safety component with the essential requirements of this Regulation or the conditions for validity of the certificate. The notified body shall examine the modification and inform the manufacturer whether the EU-type examination certificate remains valid or whether further examinations, verifications or tests are needed. As appropriate, the notified body shall issue an addition to the original EU-type examination certificate or ask for a new application for an EU-type examination to be submitted. 8. Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate. 9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. 10. The manufacturer's obligations set out in points 7 and 9, may be fulfilled by his authorised representative, provided that they are specified in the mandate. ANNEX IV CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS 1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them. 2. Manufacturing The manufacturer shall operate an approved quality system for production, final product inspection and testing of the subsystems or safety components concerned as specified in point 3, and shall be subject to surveillance as specified in point 4. 3. Quality system 3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) all relevant information for the subsystems or safety components approved under module B; (d) the documentation concerning the quality system; (e) the technical documentation of the approved type and a copy of the EU-type examination certificate(s); (f) details of the premises where the subsystem or the safety component is manufactured. 3.2. The quality system shall ensure that the subsystems or safety components are in conformity with the type(s) described in the EU-type examination certificate(s) and comply with the requirements of this Regulation that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the product quality; (b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out; (d) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.; (e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system. 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. The audit shall include an assessment visit to the premises where the subsystems or the safety components are manufactured, inspected and tested. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the field of cableway installations and in the technology of the subsystems or safety components concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.1(e), to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or safety components with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of the outcome of the evaluation. In case of a reassessment, it shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 4. Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. 4.3. The notified body shall carry out periodic audits of at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 5. CE marking and EU declaration of conformity 5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component model and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or safety component model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 6. The manufacturer shall, for a period of 30 years after the subsystem or safety component has been placed on the market, keep at the disposal of the national authorities: (a) the documentation referred to in point 3.1; (b) the information relating to the change referred to in point 3.5, as approved; (c) the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. 7. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, giving the reasons for its decision, and, upon request, of quality system approvals which it has issued. On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued. The notified body shall keep a copy of each approval decision issued and its annexes and additions. 8. Authorised representative The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. ANNEX V CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE F: CONFORMITY TO TYPE BASED ON SUBSYSTEM OR SAFETY COMPONENT VERIFICATION 1. Conformity to type based on subsystem or safety component verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, and ensures and declares on his sole responsibility that the subsystems or safety components concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them. 2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured subsystems or safety components with the approved type described in the EU-type examination certificate and with the requirements of this Regulation that apply to them. 3. Verification 3.1. The manufacturer shall lodge an application for subsystem or safety component verification with the notified body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) all relevant information for the subsystems or safety components approved under module B; (d) the technical documentation of the approved type and a copy of the EU-type examination certificate(s); (e) details of the premises where the subsystem or the safety component can be examined. 3.2. The notified body shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the subsystems or safety components with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation. The examinations and tests to check the conformity of the subsystems or safety components with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every subsystem or safety component as specified in point 4 or by examination and testing of the subsystems or safety components on a statistical basis as specified in point 5. 4. Verification of conformity by examination and testing of every subsystem or safety component 4.1. All subsystems or safety components shall be individually examined and appropriate tests set out in the relevant harmonised standard(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. 4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved subsystem or safety component or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 30 years after the subsystem or safety component has been placed on the market. 5. Statistical verification of conformity 5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his subsystem or safety component for verification in the form of homogeneous lots. 5.2. A random sample shall be taken from each lot. All the subsystems or safety components in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the EU-type examination certificate and with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. 5.3. If a lot is accepted, all the subsystems or safety components of the lot shall be considered approved, except for those subsystems or safety components from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved subsystem or safety component or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. 5.4. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent the placing on the market of that lot. In the event of the frequent rejection of lots, the notified body may suspend the statistical verification and take appropriate measures. 6. CE marking and EU declaration of conformity 6.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter's identification number to each individual subsystem or safety component that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation. 6.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component model and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or safety component model for which it has been drawn up. If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the subsystems or safety components. 7. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the subsystems or safety components during the manufacturing process. 8. Authorised representative The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the obligations set out in points 2 and 5.1. ANNEX VI CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE G: CONFORMITY BASED ON UNIT VERIFICATION 1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3.1 and 4, and ensures and declares on his sole responsibility that the subsystem or safety component concerned, which has been subject to the provisions of point 3, is in conformity with the requirements of this Regulation that apply to it. 2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured subsystem or safety component with the applicable requirements of this Regulation. 3. Verification 3.1. The manufacturer shall lodge an application for unit verification of a subsystem or a safety component with the notified body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) the technical documentation for the subsystem or the safety component according to Annex VIII; (d) details of the premises where the subsystem or the safety component can be examined. 3.2. The notified body shall examine the technical documentation for the subsystem or the safety component and shall carry out the appropriate examinations and tests set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the subsystem or the safety component with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved subsystem or safety component, or have it affixed under its responsibility. If the notified body refuses to issue a certificate of conformity, it shall state in detail the reasons for the refusal and indicate the necessary corrective measures to be taken. When the manufacturer reapplies for unit verification of the subsystem or the safety component concerned, he shall apply to the same notified body. On request, the notified body shall provide the Commission and the Member States with a copy of the certificate of conformity. The manufacturer shall keep the technical documentation and the certificate of conformity at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. 4. CE marking and EU declaration of conformity 4.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter's identification number to each subsystem or safety component that satisfies the applicable requirements of this Regulation. 4.2. The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or the safety component for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 5. Authorised representative The manufacturer's obligations set out in points 3.1 and 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. ANNEX VII CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE H 1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION 1. Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned satisfy the requirements of this Regulation that apply to them. 2. Manufacturing The manufacturer shall operate an approved quality system for the design, manufacture and final inspection and testing of subsystems or safety components as specified in point 3 and shall be subject to surveillance as specified in point 4. The adequacy of the technical design of the subsystems or safety components shall have been examined in accordance with point 3.6. 3. Quality system 3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the subsystems or safety components concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) all necessary information on the subsystems or safety components to be manufactured; (c) the technical documentation in accordance with Annex VIII for one representative type of each category of subsystem or safety component to be manufactured; (d) the documentation concerning the quality system; (e) the address of the premises where the subsystems or safety components are designed, manufactured, inspected and tested; (f) a written declaration that the same application has not been lodged with any other notified body. 3.2. The quality system shall ensure compliance of the subsystems or the safety components with the requirements of this Regulation that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the design and product quality; (b) the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means, including other relevant technical specifications, that will be used to ensure that the essential requirements of this Regulation will be met; (c) the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystems or the safety components; (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (e) the examinations and tests to be carried out before, during and after manufacture, and the frequency with which they will be carried out; (f) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.; (g) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. The audit shall include an assessment visit to the premises where the subsystems or the safety components are designed, manufactured, inspected and tested. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the field of cableway installations and in the technology of the subsystems or safety components concerned, and knowledge of the applicable requirements of this Regulation. The auditing team shall review the technical documentation referred to in point 3.1 to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or the safety components with those requirements. The notified body shall notify its decision to the manufacturer or his authorised representative. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer or the authorised representative of its decision. The notification shall contain the conclusions of the assessment and the reasoned assessment decision. 3.6. Design examination 3.6.1. The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1. 3.6.2. The application shall make it possible to understand the design, manufacture and operation of the subsystem or safety component, and to assess the conformity with the requirements of this Regulation that apply to it. It shall include: (a) the name and address of the manufacturer; (b) a written declaration that the same application has not been lodged with any other notified body; (c) the technical documentation as described in Annex VIII. 3.6.3. The notified body shall examine the application and, where the design meets the requirements of this Regulation that apply to the subsystem or safety component, it shall issue an EU design examination certificate to the manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. That certificate may have one or more annexes attached. That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems or safety components with the examined design to be evaluated and to allow for in-service control, where applicable. Where the design does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 3.6.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval from the notified body that issued the EU design examination certificate in the form of an addition to the original EU design examination certificate. 3.6.5. Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate. 3.6.6. The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 30 years after the subsystem or safety component has been placed on the market. 4. Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.; (c) the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 5. CE marking and EU declaration of conformity. 5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that satisfies the applicable requirements of this Regulation. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component model and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or the safety component model for which it has been drawn up and shall refer to the number of the EU design examination certificate. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 6. The manufacturer shall, for a period of 30 years after the subsystem or safety component has been placed on the market, keep at the disposal of the national authorities: (a) the technical documentation referred to in point 3.1(c); (b) the documentation concerning the quality system referred to in point 3.1(d); (c) the information relating to the change referred to in point 3.5 as approved; (d) the decisions and reports of the notified body referred to in points 3.3, 3.5, 4.3 and 4.4. 7. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn and, upon request, of quality system approvals which it has issued. On request, the notified body shall provide the Commission and the Member States with a copy of the quality system approval decision(s) issued. The notified body shall keep a copy of the quality system approval decision(s) issued, its annexes and additions, as well as the technical file, for a period of 30 years from the date of their issue. 8. Authorised representative The manufacturer's obligations set out in points 3.1, 3.6.4, 3.6.6, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. ANNEX VIII TECHNICAL DOCUMENTATION FOR SUBSYSTEMS AND SAFETY COMPONENTS 1. The technical documentation shall make it possible to assess the conformity of the subsystem or the safety component with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risks. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the conformity assessment, the design, manufacture and operation of the subsystem or safety component. 2. The technical documentation shall contain, at least the following elements: (a) a general description of the subsystem or the safety component; (b) design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc. and the descriptions and explanations necessary for the understanding of those drawings and diagrams and of the operation of the subsystem or safety component; (c) a list of the harmonised standards referred to in Article 17, applied in full or in part, the references of which have been published in the Official Journal of the European Union, and where those harmonised standards have not been applied descriptions of the solutions adopted to meet the essential requirements of this Regulation including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; (d) the supporting evidence for the adequacy of the design, including the results of any design calculations, examinations or tests carried out by or for the manufacturer and the related reports; (e) a copy of the instructions for the subsystem or the safety component; (f) for subsystems, copies of the EU declarations of conformity for the safety components incorporated into the subsystem. ANNEX IX EU DECLARATION OF CONFORMITY FOR SUBSYSTEMS AND SAFETY COMPONENTS No \u2026 (*) 1. Subsystem/safety component or subsystem/safety component model (product, type, batch, or serial number): 2. Name and address of the manufacturer and, where applicable, his authorised representative: 3. This declaration of conformity is issued under the sole responsibility of the manufacturer. 4. Object of the declaration (identification of the subsystem or safety component allowing traceability. It may, where necessary for the identification of the subsystem or safety component, include an image): \u2014 description of the subsystem or safety component, \u2014 all relevant provisions with which the safety component must comply and, in particular, the conditions of use. 5. The object of the declaration described in point 4 is in conformity with the relevant Union harmonisation legislation: \u2026 6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared: 7. The notified body \u2026 (name, address, number) \u2026 performed \u2026 (description of intervention) \u2026 and issued the certificate(s): \u2026 (details, including its date, and where appropriate, information on the duration and conditions of its validity). 8. Additional information: Signed for and on behalf of: \u2026 (place and date of issue): (name, function) (signature): (*) It is optional for the manufacturer to assign a number to the declaration of conformity. ANNEX X CORRELATION TABLE Directive 2000/9/EC This Regulation \u2014 Article 1 Article 1(1) Article 2(1) Article 1(2) Article 3, point 1 Article 1(3) Article 3, points 7 to 9 Article 1(4) first subparagraph Article 2(1) Article 1(4) second subparagraph \u2014 Article 1(4) third subparagraph Article 9(3) Article 1(5) Article 3, points 1, 3 to 6 Article 1(6) Article 2(2) Article 2 \u2014 Article 3(1) Article 6 Article 3(2) Article 17 \u2014 Article 3, points 10 to 27 Article 4 Article 8 Article 5(1) Article 4 and Article 5(1) Article 5(2) Article 5(4) Article 6 Article 7 Article 7(1) to (3) Articles 18 to 21 Article 7(4) Article 19(3) Article 8 Article 4 Article 9 Article 7 Article 10 Articles 18 to 21 Article 11(1) Article 9(1) Article 11(2) Article 9(4) Article 11(3) \u2014 Article 11(4) Article 5(1) Article 11(5) Article 7 Article 11(6) and (7) Article 9(2) \u2014 Articles 11 to 16 Article 12 Article 9(4) Article 13 Article 10(1) Article 14 Articles 39 to 43 Article 15 Article 10(2) Article 16 Articles 22 to 38 Article 17 Article 44 Article 18 Articles 20 and 21 Article 19 \u2014 Article 20 \u2014 Article 21(3) Article 46 Article 22 Article 48 \u2014 Article 45 \u2014 Article 47 Annex I Annex I Annex II Annex II Annex III Article 8 Annex IV Annex IX Annex V Annexes III to VII Annex VI Annex IX Annex VII Annexes III to VII Annex VIII Article 26 Annex IX Article 20 \u2014 Annex VIII", "summary": "Cableway installations for passengers Cableway installations for passengers SUMMARY OF: Regulation (EU) 2016/424 \u2014 cableway installations WHAT IS THE AIM OF THE REGULATION? It sets out rules on the essential safety requirements, design, construction and entry into service of new cableways carrying passengers. These ensure passenger safety and enable the equipment to be sold and used throughout the EU. The regulation replaces Directive 2000/9/EC. KEY POINTS The legislation applies to new cableway installations*, to modifications to existing cableway installations which require authorisation and to subsystems* and safety components* for cableways installations. They must all meet the essential safety requirements contained in Annex II of the regulation. Annex II contains essential requirements that cover all aspects of cableway installations, including maintenance and operability, ranging from dimensions and assembly to towing and control devices. The national person or authority responsible for cableway installations must carry out a comprehensive safety analysis of each planned installation and include the results in a safety report. EU countries must: ensure no operating cableway installation is liable to endanger the health or safety of people or property when they are properly installed, maintained and operated according to their intended purpose; set procedures for authorising the construction and entry into service of cableways installations under their jurisdiction; allow cableway installations to remain in operation only if they comply with the conditions in the safety report. Manufacturers of subsystems and safety components must: ensure these are designed and made according to the essential requirements set out in Annex II; keep technical documentation and the EU declaration of conformity for 30 years; give them an identifiable type, batch or serial number; indicate their contact details; provide easily understandable use and safety information; inform national authorities immediately if a subsystem or safety component presents a risk. Obligations are placed on importers and distributors to ensure that the subsystems or safety components satisfy the essential requirements. EU countries inform the European Commission of the various bodies which are authorised to carry out the conformity assessment tests. The Commission organises exchange of experience between national authorities. EU countries must have penalties in place for any violations of the law by 21 March 2018. The legislation does not apply to: lifts covered by separate EU legislation (Directive 2014/33/EU); pre-1 January 1986 cableways still operating and considered to be of historic, cultural or heritage interest, that have not had not any significant changes in design or construction, including subsystems and safety components specifically designed for them; installations used for agricultural or forestry purposes; cableways transporting goods and specifically designated people to mountain shelters and huts; leisure equipment in fairgrounds and amusement parks; mining and industrial installations; waterborne installations. FROM WHEN DOES THE REGULATION APPLY? It applies from 21 April 2018, apart from certain articles dealing largely with notification bodies and procedures. These apply from 21 October 2016. BACKGROUND The legislation covers cablecars, funiculars and chairlifts carrying people, particularly in high-altitude tourist resorts, urban transport and sport facilities. Traction by cable and passenger transport are the 2 essential criteria determining whether a cableway installation is covered by the legislation. For more information, see: \u2018Cableways\u2019 on the European Commission's website. * KEY TERMS Cableway installation: a whole on-site system, including infrastructure and subsystems, to transport people by cable. Subsystem: system or a combination of systems intended to be incorporated into a cableway installation, such as winding gear, suspension and electrotechnical devices. Safety component: component of equipment or any device intended to be incorporated into a subsystem or an installation for the purpose of ensuring a safety function. MAIN DOCUMENT Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, pp. 1-50) Successive amendments to Regulation (EU) 2016/424 have been incorporated in the original text. This consolidated version is of documentary value only. last update 13.12.2016"}
{"article": "7.6.2019 EN Official Journal of the European Union L 151/70 DIRECTIVE (EU) 2019/882 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 April 2019 on the accessibility requirements for products and services (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The purpose of this Directive is to contribute to the proper functioning of the internal market by approximating laws, regulations and administrative provisions of the Member States as regards accessibility requirements for certain products and services by, in particular, eliminating and preventing barriers to the free movement of certain accessible products and services arising from divergent accessibility requirements in the Member States. This would increase the availability of accessible products and services in the internal market and improve the accessibility of relevant information. (2) The demand for accessible products and services is high and the number of persons with disabilities is projected to increase significantly. An environment where products and services are more accessible allows for a more inclusive society and facilitates independent living for persons with disabilities. In this context, it should be borne in mind that the prevalence of disability in the Union is higher among women than among men. (3) This Directive defines persons with disabilities in line with the United Nations Convention on the Rights of Persons with Disabilities, adopted on 13 December 2006 (UN CRPD), to which the Union has been a Party since 21 January 2011 and which all Member States have ratified. The UN CRPD states that persons with disabilities \u2018include those who have long-term physical, mental, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others\u2019. This Directive promotes full and effective equal participation by improving access to mainstream products and services that, through their initial design or subsequent adaptation, address the particular needs of persons with disabilities. (4) Other persons who experience functional limitations, such as elderly persons, pregnant women or persons travelling with luggage, would also benefit from this Directive. The concept of \u2018persons with functional limitations\u2019, as referred to in this Directive, includes persons who have any physical, mental, intellectual or sensory impairments, age related impairments, or other human body performance related causes, permanent or temporary, which, in interaction with various barriers, result in their reduced access to products and services, leading to a situation that requires those products and services to be adapted to their particular needs. (5) The disparities between the laws, regulations and administrative provisions of Member States concerning the accessibility of products and services for persons with disabilities, create barriers to the free movement of products and services and distort effective competition in the internal market. For some products and services, those disparities are likely to increase in the Union after the entry into force of the UN CRPD. Economic operators, in particular small and medium-sized enterprises (SMEs), are particularly affected by those barriers. (6) Due to the differences in national accessibility requirements, individual professionals, SMEs and microenterprises in particular are discouraged from entering into business ventures outside their own domestic markets. The national, or even regional or local, accessibility requirements that Member States have put in place currently differ as regards both coverage and level of detail. Those differences negatively affect competitiveness and growth, due to the additional costs incurred in the development and marketing of accessible products and services for each national market. (7) Consumers of accessible products and services and of assistive technologies, are faced with high prices due to limited competition among suppliers. Fragmentation among national regulations reduces potential benefits derived from sharing with national and international peers experiences concerning responding to societal and technological developments. (8) The approximation of national measures at Union level is therefore necessary for the proper functioning of the internal market in order to put an end to fragmentation in the market of accessible products and services, to create economies of scale, to facilitate cross-border trade and mobility, as well as to help economic operators to concentrate resources on innovation instead of using those resources to cover expenses arising from fragmented legislation across the Union. (9) The benefits of harmonising accessibility requirements for the internal market have been demonstrated by the application of Directive 2014/33/EU of the European Parliament and of the Council (3) regarding lifts and Regulation (EC) No 661/2009 of the European Parliament and of the Council (4) in the area of transport. (10) In Declaration No 22, regarding persons with a disability, annexed to the Treaty of Amsterdam, the Conference of the Representatives of the Governments of the Member States agreed that, in drawing up measures under Article 114 of the Treaty on the Functioning of the European Union (TFEU), the institutions of the Union are to take account of the needs of persons with disabilities. (11) The overall aim of the communication of the Commission of 6 May 2015\u2018A Digital Single Market Strategy for Europe\u2019, is to deliver sustainable economic and social benefits from a connected digital single market, thereby facilitating trade and promoting employment within the Union. Union consumers still do not enjoy the full benefits of prices and choice that the single market can offer, because cross-border online transactions are still very limited. Fragmentation also limits demand for cross-border e-commerce transactions. There is also a need for concerted action to ensure that electronic content, electronic communications services and access to audiovisual media services are fully available to persons with disabilities. It is therefore necessary to harmonise accessibility requirements across the digital single market and to ensure that all Union citizens, regardless of their abilities, can enjoy its benefits. (12) Since the Union became a Party to the UN CRPD, its provisions have become an integral part of the Union legal order and are binding upon the institutions of the Union and on its Member States. (13) The UN CRPD requires its Parties to take appropriate measures to ensure that persons with disabilities have access, on an equal basis with others, to the physical environment, to transportation, to information and communications, including information and communications technologies and systems, and to other facilities and services open or provided to the public, both in urban and in rural areas. The United Nations Committee on the Rights of Persons with Disabilities has identified the need to create a legislative framework with concrete, enforceable and time-bound benchmarks for monitoring the gradual implementation of accessibility. (14) The UN CRPD calls on its Parties to undertake or promote research and development of, and to promote the availability and use of, new technologies, including information and communications technologies, mobility aids, devices and assistive technologies, suitable for persons with disabilities. The UN CRPD also calls for priority to be given to affordable technologies. (15) The entry into force of the UN CRPD in the Member States\u2019 legal orders entails the need to adopt additional national provisions on accessibility of products and services. Without Union action, those provisions would further increase disparities between the laws, regulations and administrative provisions of the Member States. (16) It is therefore necessary to facilitate the implementation in the Union of the UN CRPD by providing common Union rules. This Directive also supports Member States in their efforts to fulfil their national commitments, as well as their obligations under the UN CRPD regarding accessibility in a harmonised manner. (17) The communication of the Commission of 15 November 2010\u2018European Disability Strategy 2010-2020 \u2013 A Renewed Commitment to a Barrier-Free Europe\u2019 \u2013 in line with the UN CRPD, identifies accessibility as one of the eight areas of action, indicates that it is a basic precondition for participation in society, and aims to ensure the accessibility of products and services. (18) The determination of the products and services falling within the scope of this Directive is based on a screening exercise which was carried out during the preparation of the Impact Assessment that identified relevant products and services for persons with disabilities, and for which Member States have adopted or are likely to adopt diverging national accessibility requirements disruptive to the functioning of the internal market. (19) In order to ensure the accessibility of the services falling within the scope of this Directive, products used in the provision of those services with which the consumer interacts should also be required to comply with the applicable accessibility requirements of this Directive. (20) Even if a service, or part of a service, is subcontracted to a third party, the accessibility of that service should not be compromised and the service providers should comply with the obligations of this Directive. Service providers should also ensure proper and continuous training of their personnel in order to ensure that they are knowledgeable about how to use accessible products and services. That training should cover issues such as information provision, advice and advertising. (21) Accessibility requirements should be introduced in the manner that is least burdensome for the economic operators and the Member States. (22) It is necessary to specify accessibility requirements for the placing on the market of products and services which fall within the scope of this Directive, in order to ensure their free movement in the internal market. (23) This Directive should make functional accessibility requirements compulsory and they should be formulated in terms of general objectives. Those requirements should be precise enough to create legally binding obligations and sufficiently detailed so as to make it possible to assess conformity in order to ensure the good functioning of the internal market for the products and services covered by this Directive, as well as leave a certain degree of flexibility in order to allow for innovation. (24) This Directive contains a number of functional performance criteria related to modes of operations of products and services. Those criteria are not meant as a general alternative to the accessibility requirements of this Directive but should be used in very specific circumstances only. Those criteria should apply to specific functions or features of the products or services, to make them accessible, when the accessibility requirements of this Directive do not address one or more of those specific functions or features. In addition, in the event that an accessibility requirement contains specific technical requirements, and an alternative technical solution for those technical requirements is provided in the product or service, this alternative technical solution should still comply with the related accessibility requirements, and should result in equivalent or increased accessibility, by applying the relevant functional performance criteria. (25) This Directive should cover consumer general purpose computer hardware systems. For those systems to perform in an accessible manner, their operating systems should also be accessible. Such computer hardware systems are characterised by their multipurpose nature and their ability to perform, with the appropriate software, the most common computing tasks requested by consumers and are intended to be operated by consumers. Personal computers, including desktops, notebooks, smartphones and tablets are examples of such computer hardware systems. Specialised computers embedded in consumer electronics products do not constitute consumer general purpose computer hardware systems. This Directive should not cover, on an individual basis, single components with specific functions, such as a mainboard or a memory chip, that are used or that might be used in such a system. (26) This Directive should also cover payment terminals, including both their hardware and software, and certain interactive self-service terminals, including both their hardware and software, dedicated to be used for the provision of services covered by this Directive: for example automated teller machines; ticketing machines issuing physical tickets granting access to services such as travel ticket dispensers; bank office queuing ticket machines; check-in machines; and interactive self-service terminals providing information, including interactive information screens. (27) However, certain interactive self-service terminals providing information installed as integrated parts of vehicles, aircrafts, ships or rolling stock should be excluded from the scope of this Directive, since these form part of those vehicles, aircrafts, ships or rolling stock which are not covered by this Directive. (28) This Directive should also cover electronic communications services including emergency communications as defined in Directive (EU) 2018/1972 of the European Parliament and of the Council (5). At present, the measures taken by Member States to provide access to persons with disabilities are divergent and are not harmonised throughout the internal market. Ensuring that the same accessibility requirements apply throughout the Union will lead to economies of scale for economic operators active in more than one Member State and facilitate the effective access for persons with disabilities, both in their own Member State and when travelling between Member States. For electronic communications services including emergency communications to be accessible, providers should, in addition to voice, provide real time text, and total conversation services where video is provided by them, ensuring the synchronisation of all those communication means. Member States should, in addition to the requirements of this Directive, in accordance with Directive (EU) 2018/1972, be able to determine a relay service provider that could be used by persons with disabilities. (29) This Directive harmonises accessibility requirements for electronic communications services and related products and complements Directive (EU) 2018/1972 which sets requirements on equivalent access and choice for end-users with disabilities. Directive (EU) 2018/1972 also sets requirements under universal service obligations on the affordability of internet access and voice communications and on the affordability and availability of related terminal equipment, specific equipment and services for consumers with disabilities. (30) This Directive should also cover consumer terminal equipment with interactive computing capability foreseeably to be primarily used to access electronic communications services. For the purposes of this Directive that equipment should be deemed to include equipment used as part of the setup in accessing electronic communications services such as a router or a modem. (31) For the purposes of this Directive, access to audiovisual media services should mean that the access to audiovisual content is accessible, as well as mechanisms that allow users with disabilities to use their assistive technologies. Services providing access to audiovisual media services could include websites, online applications, set-top box-based applications, downloadable applications, mobile device-based services including mobile applications and related media players as well as connected television services. Accessibility of audiovisual media services is regulated in Directive 2010/13/EU of the European Parliament and of the Council (6), with the exception of the accessibility of electronic programme guides (EPGs) which are included in the definition of services providing access to audiovisual media services to which this Directive applies. (32) In the context of air, bus, rail and waterborne passenger transport services this Directive should cover, inter alia, the delivery of transport service information including real-time travel information through websites, mobile device-based services, interactive information screens and interactive self-service terminals, required by passengers with disabilities in order to travel. This could include information about the service provider\u2019s passenger transport products and services, pre-journey information, information during the journey and information provided when a service is cancelled or its departure is delayed. Other elements of information could also include information on prices and promotions. (33) This Directive should also cover websites, mobile device-based services including mobile applications developed or made available by operators of passenger transport services within the scope of this Directive or on their behalf, electronic ticketing services, electronic tickets and interactive self-service terminals. (34) The determination of the scope of this Directive with regard to air, bus, rail and waterborne passenger transport services should be based on the existing sectorial legislation relating to passenger rights. Where this Directive does not apply to certain types of transport services, Member States should encourage service providers to apply the relevant accessibility requirements of this Directive. (35) Directive (EU) 2016/2102 of the European Parliament and of the Council (7) already lays down obligations for public sector bodies providing transport services, including urban and suburban transport services and regional transport services, to make their websites accessible. This Directive contains exemptions for microenterprises providing services, including urban and suburban transport services and regional transport services. In addition, this Directive includes obligations to ensure that e-commerce websites are accessible. Since this Directive contains obligations for the large majority of private transport service providers to make their websites accessible, when selling tickets online, it is not necessary to introduce in this Directive further requirements for the websites of urban and suburban transport service providers and regional transport service providers. (36) Certain elements of the accessibility requirements, in particular in relation to the provision of information as set out in this Directive, are already covered by existing Union law in the field of passenger transport. This includes elements of Regulation (EC) No 261/2004 of the European Parliament and of the Council (8), Regulation (EC) No 1107/2006 of the European Parliament and of the Council (9), Regulation (EC) No 1371/2007 of the European Parliament and of the Council (10), Regulation (EU) No 1177/2010 of the European Parliament and of the Council (11) and Regulation (EU) No 181/2011 of the European Parliament and of the Council (12). This includes also relevant acts adopted on the basis of Directive 2008/57/EC of the European Parliament and of the Council (13). To ensure regulatory consistency, the accessibility requirements set out in those Regulations and those acts should continue to apply as before. However, additional requirements of this Directive would supplement the existing requirements, improving the functioning of the internal market in the area of transport and benefiting persons with disabilities. (37) Certain elements of transport services should not be covered by this Directive when provided outside the territory of the Member States even where the service has been directed towards the Union market. With regard to those elements, a passenger transport service operator should only be obliged to ensure that the requirements of this Directive are met with regard to the part of the service offered within the territory of the Union. However, in the case of air transport, Union air carriers should ensure that the applicable requirements of this Directive are also satisfied on flights departing from an airport situated in a third country and flying to an airport situated within the territory of a Member State. Furthermore, all air carriers, including those which are not licenced in the Union, should ensure that the applicable requirements of this Directive are satisfied in cases where the flights depart from a Union territory to a third country territory. (38) Urban authorities should be encouraged to integrate barrier-free accessibility to urban transport services in their Sustainable Urban Mobility Plans (SUMPs), as well as to regularly publish lists of best practices regarding barrier-free accessibility to urban public transport and mobility. (39) Union law on banking and financial services aims to protect and provide information to consumers of those services across the Union but does not include accessibility requirements. With a view to enabling persons with disabilities to use those services throughout the Union, including where provided through websites and mobile device-based services including mobile applications, to make well-informed decisions, and to feel confident that they are adequately protected on an equal basis with other consumers, as well as ensure a level playing field for service providers, this Directive should establish common accessibility requirements for certain banking and financial services provided to consumers. (40) The appropriate accessibility requirements should also apply to identification methods, electronic signature and payment services, since they are necessary for concluding consumer banking transactions. (41) E-book files are based on a electronic computer coding that enables the circulation and consultation of a mostly textual and graphical intellectual work. The degree of precision of this coding determines the accessibility of e-book files, in particular regarding the qualification of the different constitutive elements of the work and the standardised description of its structure. The interoperability in terms of accessibility should optimise the compatibility of those files with the user agents and with current and future assistive technologies. Specific features of special volumes like comics, children\u2019s books and art books should be considered in the light of all applicable accessibility requirements. Divergent accessibility requirements in Member States would make it difficult for publishers and other economic operators to benefit from the advantages of the internal market, could create interoperability problems with e-readers and would limit the access for consumers with disabilities. In the context of e-books, the concept of a service provider could include publishers and other economic operators involved in their distribution. It is recognised that persons with disabilities continue to face barriers to accessing content which is protected by copyright and related rights, and that certain measures have already been taken to address this situation for example through the adoption of Directive (EU) 2017/1564 of the European Parliament and of the Council (14) and Regulation (EU) 2017/1563 of the European Parliament and of the Council (15), and that further Union measures could be taken in this respect in the future. (42) This Directive defines e-commerce services as a service provided at a distance, through websites and mobile device-based services, by electronic means and at the individual request of a consumer, with a view to concluding a consumer contract. For the purposes of that definition \u2018at a distance\u2019 means that the service is provided without the parties being simultaneously present; \u2018by electronic means\u2019 means that the service is initially sent and received at its destination by means of electronic equipment for the processing (including digital compression) and storage of data, and transmitted, conveyed and received in its entirety by wire, by radio, by optical means or by other electromagnetic means; \u2018at the individual request of a consumer\u2019 means that the service is provided on individual request. Given the increased relevance of e-commerce services and their high technological nature, it is important to have harmonised requirements for their accessibility. (43) The e-commerce services accessibility obligations of this Directive should apply to the online sale of any product or service and should therefore also apply to the sale of a product or service covered in its own right under this Directive. (44) The measures related to the accessibility of the answering of emergency communications should be adopted without prejudice to, and should have no impact on, the organisation of emergency services, which remains in the exclusive competence of Member States. (45) In accordance with Directive (EU) 2018/1972, Member States are to ensure that access for end-users with disabilities to emergency services is available through emergency communications and is equivalent to that enjoyed by other end-users, in accordance with Union law harmonising accessibility requirements for products and services. The Commission and the national regulatory or other competent authorities are to take appropriate measures to ensure that, whilst travelling in another Member State, end-users with disabilities can access emergency services on an equivalent basis with other end-users, where feasible without any pre-registration. Those measures seek to ensure interoperability across Member States and are to be based, to the greatest extent possible, on European standards or specifications laid down in accordance with Article 39 of Directive (EU) 2018/1972. Such measures do not prevent Member States from adopting additional requirements in order to pursue the objectives set out in that Directive. As an alternative to fulfilling the accessibility requirements with regard to the answering of emergency communications for users with disabilities set out in this Directive, Member States should be able to determine a third party relay service provider to be used by persons with disabilities to communicate with the public safety answering point, until those public safety answering points are capable of using electronic communications services through internet protocols for ensuring accessibility of answering the emergency communications. In any case, obligations of this Directive should not be understood to restrict or lower any obligations for the benefit of end-users with disabilities, including equivalent access to electronic communications services and emergency services as well as accessibility obligations as set out in Directive (EU) 2018/1972. (46) Directive (EU) 2016/2102 defines accessibility requirements for websites and mobile applications of public sector bodies and other related aspects, in particular requirements relating to the compliance of the relevant websites and mobile applications. However, that Directive contains a specific list of exceptions. Similar exceptions are relevant for this Directive. Some activities that take place via websites and mobile applications of public sector bodies, such as passenger transport services or e-commerce services, which fall within the scope of this Directive, should in addition comply with the applicable accessibility requirements of this Directive in order to ensure that the online sale of products and services is accessible for persons with disabilities irrespective whether the seller is a public or private economic operator. The accessibility requirements of this Directive should be aligned to the requirements of Directive (EU) 2016/2102, despite differences, for example, in monitoring, reporting and enforcement. (47) The four principles of accessibility of websites and mobile applications, as used in Directive (EU) 2016/2102, are: perceivability, meaning that information and user interface components must be presentable to users in ways they can perceive; operability, meaning that user interface components and navigation must be operable; understandability, meaning that information and the operation of the user interface must be understandable; and robustness, meaning that content must be robust enough to be interpreted reliably by a wide variety of user agents, including assistive technologies. Those principles are also relevant for this Directive. (48) Member States should take all appropriate measures to ensure that, where the products and services covered by this Directive comply with the applicable accessibility requirements, their free movement within the Union is not impeded for reasons related to accessibility requirements. (49) In some situations, common accessibility requirements of the built environment would facilitate the free movement of the related services and of persons with disabilities. Therefore, this Directive should enable Member States to include the built environment used in the provision of the services under the scope of this Directive, ensuring compliance with the accessibility requirements set out in Annex III. (50) Accessibility should be achieved by the systematic removal and prevention of barriers, preferably through a universal design or \u2018design for all\u2019 approach, which contributes to ensuring access for persons with disabilities on an equal basis with others. According to the UN CRPD, that approach \u2018means the design of products, environments, programmes and services to be usable by all people, to the greatest extent possible, without the need for adaptation or specialized design\u2019. In line with the UN CRPD, \u2019\u2018universal design\u2019 shall not exclude assistive devices for particular groups of persons with disabilities where this is needed\u2019. Furthermore, accessibility should not exclude the provision of reasonable accommodation when required by Union law or national law. Accessibility and universal design should be interpreted in line with General Comment No 2(2014) \u2013 Article 9: Accessibility as written by the Committee on the Rights of Persons with Disabilities. (51) Products and services falling within the scope of this Directive do not automatically fall within the scope of Council Directive 93/42/EEC (16). However, some assistive technologies which are medical devices, might fall within the scope of that Directive. (52) Most jobs in the Union are provided by SMEs and microenterprises. They have a crucial importance for future growth, but very often face hurdles and obstacles in developing their products or services, in particular in the cross-border context. It is therefore necessary to facilitate the work of the SMEs and microenterprises by harmonising the national provisions on accessibility while maintaining the necessary safeguards. (53) For microenterprises and SMEs to benefit from this Directive they must genuinely fulfil the requirements of Commission Recommendation 2003/361/EC (17), and the relevant case law, aimed at preventing the circumvention of its rules. (54) In order to ensure the consistency of Union law, this Directive should be based on Decision No 768/2008/EC of the European Parliament and of the Council (18), since it concerns products already subject to other Union acts, while recognising the specific features of the accessibility requirements of this Directive. (55) All economic operators falling within the scope of this Directive and intervening in the supply and distribution chain should ensure that they make available on the market only products which are in conformity with this Directive. The same should apply to economic operators providing services. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution process. (56) Economic operators should be responsible for the compliance of products and services, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of accessibility and to guarantee fair competition on the Union market. (57) The obligations of this Directive should apply equally to economic operators from the public and private sectors. (58) The manufacturer having detailed knowledge of the design and production process is best placed to carry out the complete conformity assessment. While the responsibility for the conformity of products rests with the manufacturer, market surveillance authorities should play a crucial role in checking whether products made available in the Union are manufactured in accordance with Union law. (59) Importers and distributors and should be involved in market surveillance tasks carried out by national authorities, and should participate actively, providing the competent authorities with all necessary information relating to the product concerned. (60) Importers should ensure that products from third countries entering the Union market comply with this Directive and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those products. (61) When placing a product on the market, importers should indicate, on the product, their name, registered trade name or registered trade mark and the address at which they can be contacted. (62) Distributors should ensure that their handling of the product does not adversely affect the compliance of the product with the accessibility requirements of this Directive. (63) Any economic operator that either places a product on the market under its name or trademark or modifies a product already placed on the market in such a way that compliance with applicable requirements might be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer. (64) For reasons of proportionality, accessibility requirements should only apply to the extent that they do not impose a disproportionate burden on the economic operator concerned, or to the extent that they do not require a significant change in the products and services which would result in their fundamental alteration in the light of this Directive. Control mechanisms should nevertheless be in place in order to verify entitlement to exceptions to the applicability of accessibility requirements. (65) This Directive should follow the principle of \u2018think small first\u2019 and should take account of the administrative burdens that SMEs are faced with. It should set light rules in terms of conformity assessment and should establish safeguard clauses for economic operators, rather than providing for general exceptions and derogations for those enterprises. Consequently, when setting up the rules for the selection and implementation of the most appropriate conformity assessment procedures, the situation of SMEs should be taken into account and the obligations to assess conformity of accessibility requirements should be limited to the extent that they do not impose a disproportionate burden on SMEs. In addition, market surveillance authorities should operate in a proportionate manner in relation to the size of undertakings and to the small serial or non-serial nature of the production concerned, without creating unnecessary obstacles for SMEs and without compromising the protection of public interest. (66) In exceptional cases, where the compliance with accessibility requirements of this Directive would impose a disproportionate burden on economic operators, economic operators should only be required to comply with those requirements to the extent that they do not impose a disproportionate burden. In such duly justified cases, it would not be reasonably possible for an economic operator to fully apply one or more of the accessibility requirements of this Directive. However, the economic operator should make a service or a product that falls within the scope of this Directive as accessible as possible by applying those requirements to the extent that they do not impose a disproportionate burden. Those accessibility requirements which were not considered by the economic operator to impose a disproportionate burden should apply fully. Exceptions to compliance with one or more accessibility requirements due to the disproportionate burden that they impose should not go beyond what is strictly necessary in order to limit that burden with respect to the particular product or service concerned in each individual case. Measures that would impose a disproportionate burden should be understood as measures that would impose an additional excessive organisational or financial burden on the economic operator, while taking into account the likely resulting benefit for persons with disabilities in line with the criteria set out in this Directive. Criteria based on these considerations should be defined in order to enable both economic operators and relevant authorities to compare different situations and to assess in a systematic way whether a disproportionate burden exists. Only legitimate reasons should be taken into account in any assessment of the extent to which the accessibility requirements cannot be met because they would impose a disproportionate burden. Lack of priority, time or knowledge should not be considered to be legitimate reasons. (67) The overall assessment of a disproportionate burden should be done using the criteria set out in Annex VI. The assessment of disproportionate burden should be documented by the economic operator taking into account the relevant criteria. Service providers should renew their assessment of a disproportionate burden at least every five years. (68) The economic operator should inform the relevant authorities that it has relied on the provisions of this Directive related to fundamental alteration and/or disproportionate burden. Only upon a request from the relevant authorities should the economic operator provide a copy of the assessment explaining why its product or service is not fully accessible and providing evidence of the disproportionate burden or fundamental alteration, or both. (69) If on the basis of the required assessment, a service provider concludes that it would constitute a disproportionate burden to require that all self-service terminals, used in the provision of services covered by this Directive, comply with the accessibility requirements of this Directive, the service provider should still apply those requirements to the extent that those requirements do not impose such a disproportionate burden on it. Consequently, the service providers should assess the extent to which a limited level of accessibility in all self-service terminals or a limited number of fully accessible self-service terminals would enable them to avoid a disproportionate burden that would otherwise be imposed on them, and should be required to comply with the accessibility requirements of this Directive only to that extent. (70) Microenterprises are distinguished from all other undertakings by their limited human resources, annual turnover or annual balance sheet. The burden of complying with the accessibility requirements for microenterprises therefore, in general, takes a greater share of their financial and human resources than for other undertakings and is more likely to represent a disproportionate share of the costs. A significant proportion of cost for microenterprises comes from completing or keeping paperwork and records to demonstrate compliance with the different requirements set out in Union law. While all economic operators covered by this Directive should be able to assess the proportionality of complying with the accessibility requirements of this Directive and should only comply with them to the extent they are not disproportionate, demanding such an assessment from microenterprises providing services would in itself constitute a disproportionate burden. The requirements and obligations of this Directive should therefore not apply to microenterprises providing services within the scope of this Directive. (71) For microenterprises dealing with products falling within the scope of this Directive the requirements and obligations of this Directive should be lighter in order to reduce the administrative burden. (72) While some microenterprises are exempted from the obligations of this Directive, all microenterprises should be encouraged to manufacture, import or distribute products and to provide services that comply with the accessibility requirements of this Directive, in order to increase their competitiveness as well as their growth potential in the internal market. Member States should, therefore, provide guidelines and tools to microenterprises to facilitate the application of national measures transposing this Directive. (73) All economic operators should act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market or providing services on the market. (74) In order to facilitate the assessment of conformity with the applicable accessibility requirements it is necessary to provide for a presumption of conformity for products and services which are in conformity with voluntary harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (19) for the purpose of drawing up detailed technical specifications of those requirements. The Commission has already issued a number of standardisation requests to the European standardisation organisations on accessibility, such as standardisation mandates M/376, M/473 and M/420, which would be relevant for the preparation of harmonised standards. (75) Regulation (EU) No 1025/2012 provides for a procedure for formal objections to harmonised standards that are considered not to comply with the requirements of this Directive. (76) European standards should be market-driven, take into account the public interest, as well as the policy objectives clearly stated in the Commission\u2019s request to one or more European standardisation organisations to draft harmonised standards, and be based on consensus. In the absence of harmonised standards and where needed for internal market harmonisation purposes, the Commission should be able to adopt in certain cases implementing acts establishing technical specifications for the accessibility requirements of this Directive. Recourse to technical specifications should be limited to such cases. The Commission should be able to adopt technical specifications for instance when the standardisation process is blocked due to a lack of consensus between stakeholders or there are undue delays in the establishment of a harmonised standard, for example because the required quality is not reached. The Commission should leave enough time between the adoption of a request to one or more European standardisation organisations to draft harmonised standards and the adoption of a technical specification related to the same accessibility requirement. The Commission should not be allowed to adopt a technical specification if it has not previously tried to have the accessibility requirements covered through the European standardisation system, except where the Commission can demonstrate that the technical specifications respect the requirements laid down in Annex II of Regulation (EU) No 1025/2012. (77) With a view to establishing, in the most efficient way, harmonised standards and technical specifications that meet the accessibility requirements of this Directive for products and services, the Commission should, where this is feasible, involve European umbrella organisations of persons with disabilities and all other relevant stakeholders in the process. (78) To ensure effective access to information for market surveillance purposes, the information required to declare compliance with all applicable Union acts should be made available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, they should be able to include in the single EU declaration of conformity all relevant individual declarations of conformity. (79) For conformity assessment of products, this Directive should use the Internal production control of \u2018Module A\u2019, set out in Annex II to Decision No 768/2008/EC, as it enables economic operators to demonstrate, and the competent authorities to ensure, that products made available on the market conform to the accessibility requirements while not imposing an undue burden. (80) When carrying out market surveillance of products and checking compliance of services, authorities should also check the conformity assessments, including whether the relevant assessment of fundamental alteration or disproportionate burden was properly carried out. When carrying out their duties authorities should also do so in cooperation with persons with disabilities and the organisations that represent them and their interests. (81) For services, the information necessary to assess conformity with the accessibility requirements of this Directive should be provided in the general terms and conditions, or in an equivalent document, without prejudice to Directive 2011/83/EU of the European Parliament and of the Council (20). (82) The CE marking, indicating the conformity of a product with the accessibility requirements of this Directive, is the visible consequence of a whole process comprising conformity assessment in a broad sense. This Directive should follow the general principles governing the CE marking of Regulation (EC) No 765/2008 of the European Parliament and of the Council (21) setting out the requirements for accreditation and market surveillance relating to the marketing of products. In addition to making the EU declaration of conformity, the manufacturer should inform consumers in a cost-effective manner about the accessibility of their products. (83) In accordance with Regulation (EC) No 765/2008, by affixing the CE marking to a product, the manufacturer declares that the product is in conformity with all applicable accessibility requirements and that the manufacturer takes full responsibility therefor. (84) In accordance with Decision No 768/2008/EC, Member States are responsible for ensuring strong and efficient market surveillance of products in their territories and should allocate sufficient powers and resources to their market surveillance authorities. (85) Member States should check the compliance of services with the obligations of this Directive and should follow up complaints or reports related to non-compliance in order to ensure that corrective action has been taken. (86) Where appropriate the Commission, in consultation with stakeholders, could adopt non-binding guidelines to support coordination among market surveillance authorities and authorities responsible for checking compliance of services. The Commission and Member States should be able to set up initiatives for the purpose of sharing the resources and expertise of authorities. (87) Member States should ensure that market surveillance authorities and authorities responsible for checking compliance of services check the compliance of the economic operators with the criteria set out in Annex VI in accordance with Chapters VIII and IX. Member States should be able to designate a specialised body for carrying out the obligations of market surveillance authorities or authorities responsible for checking compliance of services under this Directive. Member States should be able to decide that the competences of such a specialised body should be limited to the scope of this Directive or certain parts thereof, without prejudice to the Member States\u2019 obligations under Regulation (EC) No 765/2008. (88) A safeguard procedure should be set up to apply in the event of disagreement between Member States over measures taken by a Member State under which interested parties are informed of measures intended to be taken with regard to products not complying with the accessibility requirements of this Directive. The safeguard procedure should allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such products. (89) Where the Member States and the Commission agree that a measure taken by a Member State is justified, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings in the harmonised standards or in the technical specifications. (90) Directives 2014/24/EU (22) and 2014/25/EU (23) of the European Parliament and of the Council on public procurement, defining procedures for the procurement of public contracts and design contests for certain supplies (products), services and works, establish that, for all procurement which is intended for use by natural persons, whether general public or staff of the contracting authority or entity, the technical specifications are, except in duly justified cases, to be drawn up so as to take into account accessibility criteria for persons with disabilities or design for all users. Furthermore, those Directives require that, where mandatory accessibility requirements are adopted by a legal act of the Union, technical specifications are, as far as accessibility for persons with disabilities or design for all users are concerned, to be established by reference thereto. This Directive should establish mandatory accessibility requirements for products and services covered by it. For products and services not falling under the scope of this Directive, the accessibility requirements of this Directive are not binding. However, the use of those accessibility requirements to fulfil the relevant obligations set out in Union acts other than this Directive would facilitate the implementation of accessibility and contribute to the legal certainty and to the approximation of accessibility requirements across the Union. Authorities should not be prevented from establishing accessibility requirements that go beyond the accessibility requirements set out in Annex I to this Directive. (91) This Directive should not change the compulsory or voluntary nature of the provisions related to accessibility in other Union acts. (92) This Directive should only apply to procurement procedures for which the call for competition has been sent or, in cases where a call for competition is not foreseen, where the contracting authority or contracting entity has commenced the procurement procedure after the date of application of this Directive. (93) In order to ensure the proper application of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of: further specifying the accessibility requirements that, by their very nature, cannot produce their intended effect unless they are further specified in binding legal acts of the Union; changing the period during which economic operators are to be able to identify any other economic operator who has supplied them with a product or to whom they have supplied a product; and further specifying the relevant criteria that are to be taken into account by the economic operator for the assessment of whether compliance with the accessibility requirements would impose a disproportionate burden. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (24). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (94) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission with regard to the technical specifications. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (25). (95) Member States should ensure that adequate and effective means exist to ensure compliance with this Directive and should therefore establish appropriate control mechanisms, such as a posteriori control by the market surveillance authorities, in order to verify that the exemption from the accessibility requirements application is justified. When dealing with complaints related to accessibility, Member States should comply with the general principle of good administration, and in particular with the obligation of officials to ensure that a decision on each complaint is taken within a reasonable time-limit. (96) In order to facilitate the uniform implementation of this Directive, the Commission should establish a working group consisting of relevant authorities and stakeholders to facilitate exchange of information and of best practices and to provide advice. Cooperation should be fostered between authorities and relevant stakeholders, including persons with disabilities and organisations that represent them, inter alia, to improve coherence in the application of provisions of this Directive concerning accessibility requirements and to monitor implementation of its provisions on fundamental alteration and disproportionate burden. (97) Given the existing legal framework concerning remedies in the areas covered by Directives 2014/24/EU and 2014/25/EU, the provisions of this Directive relating to enforcement and penalties should not be applicable to the procurement procedures subject to the obligations imposed by this Directive. Such exclusion is without prejudice to the obligations of Member States under the Treaties to take all measures necessary to guarantee the application and effectiveness of Union law. (98) Penalties should be adequate in relation to the character of the infringements and to the circumstances so as not to serve as an alternative to the fulfilment by economic operators of their obligations to make their products or services accessible. (99) Member States should ensure that, in accordance with existing Union law, alternative dispute resolutions mechanisms are in place that allow the resolution of any alleged non-compliance with this Directive prior to an action being brought before courts or competent administrative bodies. (100) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (26), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a Directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (101) In order to allow service providers sufficient time to adapt to the requirements of this Directive, it is necessary to provide for a transitional period of five years after the date of application of this Directive, during which products used for the provision of a service which were placed on the market before that date do not need to comply with the accessibility requirements of this Directive unless they are replaced by the service providers during the transitional period. Given the cost and long life-cycle of self-service terminals, it is appropriate to provide that, when such terminals are used in the provision of services, they may continue to be used until the end of their economic life, as long as they are not replaced during that period, but not for longer than 20 years. (102) The accessibility requirements of this Directive should apply to products placed on the market and services provided after the date of application of the national measures transposing this Directive, including used and second-hand products imported from a third country and placed on the market after that date. (103) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (\u2018the Charter\u2019). In particular, this Directive seeks to ensure full respect for the rights of persons with disabilities to benefit from measures designed to ensure their independence, social and occupational integration and participation in the life of the community and to promote the application of Articles 21, 25 and 26 of the Charter. (104) Since the objective of this Directive, namely, the elimination of barriers to the free movement of certain accessible products and services, in order to contribute to the proper functioning of the internal market, cannot be sufficiently achieved by the Member States because it requires the harmonisation of different rules currently existing in their respective legal systems, but can rather, by defining common accessibility requirements and rules for the functioning of the internal market, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I General provisions Article 1 Subject matter The purpose of this Directive is to contribute to the proper functioning of the internal market by approximating the laws, regulations and administrative provisions of the Member States as regards accessibility requirements for certain products and services by, in particular, eliminating and preventing barriers to the free movement of products and services covered by this Directive arising from divergent accessibility requirements in the Member States. Article 2 Scope 1. This Directive applies to the following products placed on the market after 28 June 2025: (a) consumer general purpose computer hardware systems and operating systems for those hardware systems; (b) the following self-service terminals: (i) payment terminals; (ii) the following self-service terminals dedicated to the provision of services covered by this Directive: \u2014 automated teller machines; \u2014 ticketing machines; \u2014 check-in machines; \u2014 interactive self-service terminals providing information, excluding terminals installed as integrated parts of vehicles, aircrafts, ships or rolling stock; (c) consumer terminal equipment with interactive computing capability, used for electronic communications services; (d) consumer terminal equipment with interactive computing capability, used for accessing audiovisual media services; and (e) e-readers. 2. Without prejudice to Article 32, this Directive applies to the following services provided to consumers after 28 June 2025: (a) electronic communications services with the exception of transmission services used for the provision of machine-to-machine services; (b) services providing access to audiovisual media services; (c) the following elements of air, bus, rail and waterborne passenger transport services, except for urban, suburban and regional transport services for which only the elements under point (v) apply: (i) websites; (ii) mobile device-based services including mobile applications; (iii) electronic tickets and electronic ticketing services; (iv) delivery of transport service information, including real-time travel information; this shall, with regard to information screens, be limited to interactive screens located within the territory of the Union; and (v) interactive self-service terminals located within the territory of the Union, except those installed as integrated parts of vehicles, aircrafts, ships and rolling stock used in the provision of any part of such passenger transport services; (d) consumer banking services; (e) e-books and dedicated software; and (f) e-commerce services. 3. This Directive applies to answering emergency communications to the single European emergency number \u2018112\u2019. 4. This Directive does not apply to the following content of websites and mobile applications: (a) pre-recorded time-based media published before 28 June 2025; (b) office file formats published before 28 June 2025; (c) online maps and mapping services, if essential information is provided in an accessible digital manner for maps intended for navigational use; (d) third-party content that is neither funded, developed by, or under the control of, the economic operator concerned; (e) content of websites and mobile applications qualifying as archives, meaning that they only contain content that is not updated or edited after 28 June 2025. 5. This Directive shall be without prejudice to Directive (EU) 2017/1564 and Regulation (EU) 2017/1563. Article 3 Definitions For the purposes of this Directive, the following definitions apply: (1) \u2018persons with disabilities\u2019 means persons who have long-term physical, mental, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others; (2) \u2018product\u2019 means a substance, preparation, or good produced through a manufacturing process, other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction; (3) \u2018service\u2019 means a service as defined in point 1 of Article 4 of Directive 2006/123/EC of the European Parliament and of the Council (27); (4) \u2018service provider\u2019 means any natural or legal person who provides a service on the Union market or makes offers to provide such a service to consumers in the Union; (5) \u2018audiovisual media services\u2019 means services as defined in point (a) of Article 1(1) of Directive 2010/13/EU; (6) \u2018services providing access to audiovisual media services\u2019 means services transmitted by electronic communications networks which are used to identify, select, receive information on, and view audiovisual media services and any provided features, such as subtitles for the deaf and hard of hearing, audio description, spoken subtitles and sign language interpretation, which result from the implementation of measures to make services accessible as referred to in Article 7 of Directive 2010/13/EU; and includes electronic programme guides (EPGs); (7) \u2018consumer terminal equipment with interactive computing capability, used for accessing audiovisual media services\u2019 means any equipment the main purpose of which is to provide access to audiovisual media services; (8) \u2018electronic communications service\u2019 means electronic communications service as defined in point 4 of Article 2 of Directive (EU) 2018/1972; (9) \u2018total conversation service\u2019 means total conversation service as defined in point 35 of Article 2 of Directive (EU) 2018/1972; (10) \u2018public safety answering point\u2019 or \u2018PSAP\u2019 means public safety answering point or PSAP as defined in point 36 of Article 2 of Directive (EU) 2018/1972; (11) \u2018most appropriate PSAP\u2019 means most appropriate PSAP as defined in point 37 of Article 2 of Directive (EU) 2018/1972; (12) \u2018emergency communication\u2019 means emergency communication as defined in point 38 of Article 2 of Directive (EU) 2018/1972; (13) \u2018emergency service\u2019 means emergency service as defined in point 39 of Article 2 of Directive (EU) 2018/1972; (14) \u2018real time text\u2019 means a form of text conversation in point to point situations or in multipoint conferencing where the text being entered is sent in such a way that the communication is perceived by the user as being continuous on a character-by-character basis; (15) \u2018making available on the market\u2019 means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (16) \u2018placing on the market\u2019 means the first making available of a product on the Union market; (17) \u2018manufacturer\u2019 means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark; (18) \u2018authorised representative\u2019 means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks; (19) \u2018importer\u2019 means any natural or legal person established within the Union who places a product from a third country on the Union market; (20) \u2018distributor\u2019 means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; (21) \u2018economic operator\u2019 means the manufacturer, the authorised representative, the importer, the distributor or the service provider; (22) \u2018consumer\u2019 means any natural person who purchases the relevant product or is a recipient of the relevant service for purposes which are outside his trade, business, craft or profession; (23) \u2018microenterprise\u2019 means an enterprise which employs fewer than 10 persons and which has an annual turnover not exceeding EUR 2 million or an annual balance sheet total not exceeding EUR 2 million; (24) \u2018small and medium-sized enterprises\u2019 or \u2018SMEs\u2019 means enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, or an annual balance sheet total not exceeding EUR 43 million, but excludes microenterprises; (25) \u2018harmonised standard\u2019 means a harmonised standard as defined in point 1(c) of Article 2 of Regulation (EU) No 1025/2012; (26) \u2018technical specification\u2019 means a technical specification as defined in point 4 of Article 2 of Regulation (EU) No 1025/2012 that provides a means to comply with the accessibility requirements applicable to a product or service; (27) \u2018withdrawal\u2019 means any measure aimed at preventing a product in the supply chain from being made available on the market; (28) \u2018consumer banking services\u2019 means the provision to consumers of the following banking and financial services: (a) credit agreements covered by Directive 2008/48/EC of the European Parliament and of the Council (28) or Directive 2014/17/EU of the European Parliament and of the Council (29); (b) services as defined in points 1, 2, 4 and 5 in Section A and points 1, 2, 4 and 5 in Section B of Annex I to Directive 2014/65/EU of the European Parliament and of the Council (30); (c) payment services as defined in point 3 of Article 4 of Directive (EU) 2015/2366 of the European Parliament and of the Council (31); (d) services linked to the payment account as defined in point 6 of Article 2 of Directive 2014/92/EU of the European Parliament and of the Council (32); and (e) electronic money as defined in point 2 of Article 2 of Directive 2009/110/EC of the European Parliament and of the Council (33); (29) \u2018payment terminal\u2019 means a device the main purpose of which is to allow payments to be made by using payment instruments as defined in point 14 of Article 4 of Directive (EU) 2015/2366 at a physical point of sale but not in a virtual environment; (30) \u2018e-commerce services\u2019 means services provided at a distance, through websites and mobile device-based services by electronic means and at the individual request of a consumer with a view to concluding a consumer contract; (31) \u2018air passenger transport services\u2019 means commercial passenger air services, as defined in point (l) of Article 2 of Regulation (EC) No 1107/2006, on departure from, on transit through, or on arrival at an airport, when the airport is situated in the territory of a Member State, including flights departing from an airport situated in a third country to an airport situated in the territory of a Member State where the services are operated by Union air carriers; (32) \u2018bus passenger transport services\u2019 means services covered by Article 2(1) and (2) of Regulation (EU) No 181/2011; (33) \u2018rail passenger transport services\u2019 means all rail passenger services as referred to in Article 2(1) of Regulation (EC) No 1371/2007, with the exception of services referred to in Article 2(2) thereof; (34) \u2018waterborne passenger transport services\u2019 means passenger services covered by Article 2(1) of Regulation (EU) No 1177/2010, with the exception of services referred to in Article 2(2) of that Regulation; (35) \u2018urban and suburban transport services\u2019 means urban and suburban services as defined in point 6 of Article 3 of Directive 2012/34/EU of the European Parliament and of the Council (34); but for the purposes of this Directive, it includes only the following modes of transport: rail, bus and coach, metro, tram and trolley bus; (36) \u2018regional transport services\u2019 means regional services as defined in point 7 of Article 3 of Directive 2012/34/EU; but for the purposes of this Directive, it includes only the following modes of transport: rail, bus and coach, metro, tram and trolley bus; (37) \u2018assistive technology\u2019 means any item, piece of equipment, service or product system including software that is used to increase, maintain, substitute or improve functional capabilities of persons with disabilities or for, alleviation and compensation of impairments, activity limitations or participation restrictions; (38) \u2018operating system\u2019 means software, which, inter alia, handles the interface to peripheral hardware, schedules tasks, allocates storage, and presents a default interface to the user when no application program is running including a graphical user interface, regardless of whether such software is an integral part of consumer general purpose computer hardware, or constitutes free-standing software intended to be run on consumer general purpose computer hardware, but excluding an operating system loader, basic input/output system, or other firmware required at boot time or when installing the operating system; (39) \u2018consumer general purpose computer hardware system\u2019 means the combination of hardware which forms a complete computer, characterised by its multipurpose nature, its ability to perform, with the appropriate software, most common computing tasks requested by consumers and intended to be operated by consumers, including personal computers, in particular desktops, notebooks, smartphones and tablets; (40) \u2018interactive computing capability\u2019 means functionality supporting human-device interaction allowing for processing and transmission of data, voice or video or any combination thereof; (41) \u2018e-book and dedicated software\u2019 means a service, consisting of the provision of digital files that convey an electronic version of a book, that can be accessed, navigated, read and used and the software including mobile device-based services including mobile applications dedicated to the accessing, navigation, reading and use of those digital files, and it excludes software covered under the definition in point (42); (42) \u2018e-reader\u2019 means dedicated equipment, including both hardware and software, used to access, navigate, read and use e-book files; (43) \u2018electronic tickets\u2019 means any system in which an entitlement to travel, in the form of single or multiple travel tickets, travel subscriptions or travel credit, is stored electronically on a physical transport pass or other device, instead of being printed on a paper ticket; (44) \u2018electronic ticketing services\u2019 means any system in which passenger transport tickets are purchased including online using a device with interactive computing capability, and delivered to the purchaser in electronic form, to enable them to be printed in paper form or displayed using a mobile device with interactive computing capability when travelling. CHAPTER II Accessibility requirements and free movement Article 4 Accessibility requirements 1. Member States shall ensure, in accordance with paragraphs 2, 3 and 5 of this Article and subject to Article 14, that economic operators only place on the market products and only provide services that comply with the accessibility requirements set out in Annex I. 2. All products shall comply with the accessibility requirements set out in Section I of Annex I. All products, except for self-service terminals, shall comply with the accessibility requirements set out in Section II of Annex I. 3. Without prejudice to paragraph 5 of this Article, all services, except for urban and suburban transport services and regional transport services, shall comply with the accessibility requirements set out in Section III of Annex I. Without prejudice to paragraph 5 of this Article, all services shall comply with the accessibility requirements set out in Section IV of Annex I. 4. Member States may decide, in the light of national conditions, that the built environment used by clients of services covered by this Directive shall comply with the accessibility requirements set out in Annex III, in order to maximise their use by persons with disabilities. 5. Microenterprises providing services shall be exempt from complying with the accessibility requirements referred to in paragraph 3 of this Article and any obligations relating to the compliance with those requirements. 6. Member States shall provide guidelines and tools to microenterprises to facilitate the application of the national measures transposing this Directive. Member States shall develop those tools in consultation with relevant stakeholders. 7. Member States may inform economic operators of the indicative examples, contained in Annex II, of possible solutions that contribute to meeting the accessibility requirements in Annex I. 8. Member States shall ensure that the answering of emergency communications to the single European emergency number \u2018112\u2019 by the most appropriate PSAP, shall comply with the specific accessibility requirements set out in Section V of Annex I in the manner best suited to the national organisation of emergency systems. 9. The Commission is empowered to adopt delegated acts in accordance with Article 26 to supplement Annex I by further specifying the accessibility requirements that, by their very nature, cannot produce their intended effect unless they are further specified in binding legal acts of the Union, such as requirements related to interoperability. Article 5 Existing Union law in the field of passenger transport Services complying with the requirements on the provision of accessible information and of information on accessibility laid down in Regulations (EC) No 261/2004, (EC) No 1107/2006, (EC) No 1371/2007, (EU) No 1177/2010, and (EU) No 181/2011 and relevant acts adopted on the basis of Directive 2008/57/EC shall be deemed to comply with the corresponding requirements of this Directive. Where this Directive provides for requirements additional to those provided in those Regulations and those acts, the additional requirements shall apply in full. Article 6 Free movement Member States shall not impede, for reasons related to accessibility requirements, the making available on the market in their territory of products or the provision of services in their territory that comply with this Directive. CHAPTER III Obligations of economic operators dealing with products Article 7 Obligations of manufacturers 1. When placing their products on the market, manufacturers shall ensure that the products have been designed and manufactured in accordance with the applicable accessibility requirements of this Directive. 2. Manufacturers shall draw up the technical documentation in accordance with Annex IV and carry out the conformity assessment procedure set out in that Annex or have it carried out. Where compliance of a product with the applicable accessibility requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking. 3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for five years after the product has been placed on the market. 4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in product design or characteristics and changes in the harmonised standards, or in technical specifications, by reference to which conformity of a product is declared shall be adequately taken into account. 5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product. 6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities. 7. Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible. 8. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it. Furthermore, where the product does not comply with the accessibility requirements of this Directive, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. In such cases, manufacturers shall keep a register of products which do not comply with applicable accessibility requirements and of the related complaints. 9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have placed on the market, in particular bringing the products into compliance with the applicable accessibility requirements. Article 8 Authorised representatives 1. A manufacturer may, by a written mandate, appoint an authorised representative. The obligations laid down in Article 7(1) and the drawing up of technical documentation shall not form part of the authorised representative\u2019s mandate. 2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following: (a) keep the EU declaration of conformity and the technical documentation at the disposal of market surveillance authorities for five years; (b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product; (c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products covered by their mandate. Article 9 Obligations of importers 1. Importers shall place only compliant products on the market. 2. Before placing a product on the market, importers shall ensure that the conformity assessment procedure set out in Annex IV has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation required by that Annex, that the product bears the CE marking and is accompanied by the required documents and that the manufacturer has complied with the requirements set out in Article 7(5) and (6). 3. Where an importer considers or has reason to believe that a product is not in conformity with the applicable accessibility requirements of this Directive, the importer shall not place the product on the market until it has been brought into conformity. Furthermore, where the product does not comply with the applicable accessibility requirements, the importer shall inform the manufacturer and the market surveillance authorities to that effect. 4. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The contact details shall be in a language easily understood by end-users and market surveillance authorities. 5. Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. 6. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable accessibility requirements. 7. Importers shall, for a period of five years keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and shall ensure that the technical documentation can be made available to those authorities upon request. 8. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it. Furthermore, where the product does not comply with the applicable accessibility requirements, importers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. In such cases, importers shall keep a register of products which do not comply with applicable accessibility requirements, and of the related complaints. 9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have placed on the market. Article 10 Obligations of distributors 1. When making a product available on the market distributors shall act with due care in relation to the requirements of this Directive. 2. Before making a product available on the market distributors shall verify that the product bears the CE marking, that it is accompanied by the required documents and by instructions and safety information in a language which can be easily understood by consumers and other end-users in the Member State in which the product is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in Article 7(5) and (6) and Article 9(4) respectively. 3. Where a distributor considers or has reason to believe that a product is not in conformity with the applicable accessibility requirements of this Directive, the distributor shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product does not comply with the applicable accessibility requirements, the distributor shall inform the manufacturer or the importer and the market surveillance authorities to that effect. 4. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable accessibility requirements. 5. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with this Directive shall make sure that the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it, are taken. Furthermore, where the product, does not comply with the applicable accessibility requirements, distributors shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 6. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have made available on the market. Article 11 Cases in which obligations of manufacturers apply to importers and distributors An importer or distributor shall be considered a manufacturer for the purposes of this Directive and shall be subject to the obligations of the manufacturer under Article 7, where it places a product on the market under its name or trademark or modifies a product already placed on the market in such a way that compliance with the requirements of this Directive may be affected. Article 12 Identification of economic operators dealing with products 1. Economic operators referred to in Articles 7 to 10 shall, upon request, identify to the market surveillance authorities, the following: (a) any other economic operator who has supplied them with a product; (b) any other economic operator to whom they have supplied a product. 2. Economic operators referred to in Articles 7 to 10 shall be able to present the information referred to in paragraph 1 of this Article for a period of five years after they have been supplied with the product and for a period of five years after they have supplied the product. 3. The Commission is empowered to adopt delegated acts in accordance with Article 26 to amend this Directive in order to change the period referred to in paragraph 2 of this Article for specific products. That amended period shall be longer than five years, and shall be in proportion to the economically useful life of the product concerned. CHAPTER IV Obligations of service providers Article 13 Obligations of service providers 1. Service providers shall ensure that they design and provide services in accordance with the accessibility requirements of this Directive. 2. Service providers shall prepare the necessary information in accordance with Annex V and shall explain how the services meet the applicable accessibility requirements. The information shall be made available to the public in written and oral format, including in a manner which is accessible to persons with disabilities. Service providers shall keep that information for as long as the service is in operation. 3. Without prejudice to Article 32, service providers shall ensure that procedures are in place so that the provision of services remains in conformity with the applicable accessibility requirements. Changes in the characteristics of the provision of the service, changes in applicable accessibility requirements and changes in the harmonised standards or in technical specifications by reference to which a service is declared to meet the accessibility requirements shall be adequately taken into account by the service providers. 4. In the case of non-conformity, service providers shall take the corrective measures necessary to bring the service into conformity with the applicable accessibility requirements. Furthermore, where the service is not compliant with applicable accessibility requirements, service providers shall immediately inform the competent national authorities of the Member States in which the service is provided, to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 5. Service providers shall, further to a reasoned request from a competent authority, provide it with all information necessary to demonstrate the conformity of the service with the applicable accessibility requirements. They shall cooperate with that authority, at the request of that authority, on any action taken to bring the service into compliance with those requirements. CHAPTER V Fundamental alteration of products or services and disproportionate burden to economic operators Article 14 Fundamental alteration and disproportionate burden 1. The accessibility requirements referred to in Article 4 shall apply only to the extent that compliance: (a) does not require a significant change in a product or service that results in the fundamental alteration of its basic nature; and (b) does not result in the imposition of a disproportionate burden on the economic operators concerned. 2. Economic operators shall carry out an assessment of whether compliance with the accessibility requirements referred to in Article 4 would introduce a fundamental alteration or, based on the relevant criteria set out in Annex VI, impose a disproportionate burden, as provided for in paragraph 1 of this Article. 3. Economic operators shall document the assessment referred to in paragraph 2. Economic operators shall keep all relevant results for a period of five years to be calculated from the last making available of a product on the market or after a service was last provided, as applicable. Upon a request from the market surveillance authorities or from the authorities responsible for checking compliance of services, as applicable, the economic operators shall provide the authorities with a copy of the assessment referred to in paragraph 2. 4. By way of derogation from paragraph 3, microenterprises dealing with products shall be exempted from the requirement to document their assessment. However, if a market surveillance authority so requests, microenterprises dealing with products and which have chosen to rely on paragraph 1 shall provide the authority with the facts relevant to the assessment referred to in paragraph 2. 5. Service providers relying on point (b) of paragraph 1 shall, with regard to each category or type of service, renew their assessment of whether the burden is disproportionate: (a) when the service offered is altered; or (b) when requested to do so by the authorities responsible for checking compliance of services; and (c) in any event, at least every five years. 6. Where economic operators receive funding from other sources than the economic operator\u2019s own resources, whether public or private, that is provided for the purpose of improving accessibility, they shall not be entitled to rely on point (b) of paragraph 1. 7. The Commission is empowered to adopt delegated acts in accordance with Article 26 to supplement Annex VI by further specifying the relevant criteria that are to be taken into account by the economic operator for the assessment referred to in paragraph 2 of this Article. When further specifying those criteria, the Commission shall take into account not only the potential benefits for persons with disabilities, but also those for persons with functional limitations. When necessary, the Commission shall adopt the first such delegated act by 28 June 2020. Such act shall start to apply, at the earliest, in 28 June 2025. 8. Where economic operators rely on paragraph 1 for a specific product or service they shall send information to that effect to the relevant market surveillance authorities, or authorities responsible for checking the compliance of services, of the Member State where the specific product is placed on the market or the specific service is provided. The first subparagraph shall not apply to microenterprises. CHAPTER VI Harmonised standards and technical specifications of products and services Article 15 Presumption of conformity 1. Products and services which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the accessibility requirements of this Directive in so far as those standards or parts thereof cover those requirements. 2. The Commission shall, in accordance with Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the product accessibility requirements set out in Annex I. The Commission shall submit the first such draft request to the relevant committee by 28 June 2021. 3. The Commission may adopt implementing acts establishing technical specifications that meet the accessibility requirements of this Directive where the following conditions have been fulfilled: (a) no reference to harmonised standards is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012; and (b) either: (i) the Commission has requested one or more European standardisation organisations to draft a harmonised standard and there are undue delays in the standardisation procedure or the request has not been accepted by any European standardisation organisations; or (ii) the Commission can demonstrate that a technical specification respects the requirements laid down in Annex II of Regulation (EU) No 1025/2012, except for the requirement that the technical specifications should have been developed by a non-profit making organisation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). 4. Products and services which are in conformity with the technical specifications or parts thereof shall be presumed to be in conformity with the accessibility requirements of this Directive in so far as those technical specifications or parts thereof cover those requirements. CHAPTER VII Conformity of products and CE marking Article 16 EU declaration of conformity of products 1. The EU declaration of conformity shall state that the fulfilment of the applicable accessibility requirements has been demonstrated. Where as an exception, Article 14 has been used, the EU declaration of conformity shall state which accessibility requirements are subject to that exception. 2. The EU declaration of conformity shall have the model structure set out in Annex III to Decision No 768/2008/EC. It shall contain the elements specified in Annex IV to this Directive and shall be continuously updated. The requirements concerning the technical documentation shall avoid imposing any undue burden for microenterprises and SMEs. It shall be translated into the language or languages required by the Member State in which the product is placed or made available on the market. 3. Where a product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the acts concerned including the publication references. 4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements of this Directive. Article 17 General principles of the CE marking of products The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. Article 18 Rules and conditions for affixing the CE marking 1. The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate. Where that is not possible, or not warranted, on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents. 2. The CE marking shall be affixed before the product is placed on the market. 3. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. CHAPTER VIII Market surveillance of products and Union safeguard procedure Article 19 Market surveillance of products 1. Article 15(3), Articles 16 to 19, Article 21, Articles 23 to 28 and Article 29(2) and (3) of Regulation (EC) No 765/2008 shall apply to products. 2. When carrying out market surveillance of products, the relevant market surveillance authorities shall, when the economic operator has relied on Article 14 of this Directive: (a) check that the assessment referred to in Article 14 has been conducted by the economic operator; (b) review that assessment and its results, including the correct use of the criteria set out in Annex VI; and (c) check compliance with the applicable accessibility requirements. 3. Member States shall ensure that information held by market surveillance authorities concerning the compliance of economic operators with the applicable accessibility requirements of this Directive and the assessment provided for in Article 14, is made available to consumers upon request and in an accessible format, except where that information cannot be provided for reasons of confidentiality as provided for in Article 19(5) of Regulation (EC) No 765/2008. Article 20 Procedure at national level for dealing with products not complying with the applicable accessibility requirements 1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a product covered by this Directive does not comply with the applicable accessibility requirements, they shall carry out an evaluation in relation to the product concerned covering all requirements laid down in this Directive. The relevant economic operators shall fully cooperate with the market surveillance authorities for that purpose. Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the product does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the product into compliance with those requirements within a reasonable period, commensurate with the nature of the non-compliance, as they may prescribe. Market surveillance authorities shall require the relevant economic operator to withdraw the product from the market, within an additional reasonable period, only if the relevant economic operator has failed to take adequate corrective action within the period referred to in the second subparagraph. Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second and third subparagraphs of this paragraph. 2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take. 3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union. 4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the third subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the product\u2019s being made available on their national markets or to withdraw the product from that market. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. 5. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the accessibility requirements with which the product does not comply, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either: (a) the failure of the product to meet the applicable accessibility requirements; or (b) the shortcomings in the harmonised standards or in the technical specifications referred to in Article 15 conferring a presumption of conformity. 6. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the notified national measure, of their objections. 7. Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. 8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the product from their market, are taken in respect of the product concerned without delay. Article 21 Union safeguard procedure 1. Where, on completion of the procedure set out in Article 20(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission has reasonable evidence to suggest that a national measure is contrary to Union law, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. 2. Where the national measure referred to in paragraph 1 is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant product is withdrawn from their market, and shall inform the Commission accordingly. Where the national measure is considered unjustified, the Member State concerned shall withdraw the measure. 3. Where the national measure referred to in paragraph 1 of this Article is considered justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 20(5), the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012. 4. Where the national measure referred to in paragraph 1 of this Article is considered justified and the non-compliance of the product is attributed to shortcomings in the technical specifications referred to in point (b) of Article 20(5), the Commission shall, without delay, adopt implementing acts amending or repealing the technical specification concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). Article 22 Formal non-compliance 1. Without prejudice to Article 20, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 18 of this Directive; (b) the CE marking has not been affixed; (c) the EU declaration of conformity has not been drawn up; (d) the EU declaration of conformity has not been drawn up correctly; (e) technical documentation is either not available or not complete; (f) the information referred to in Article 7(6) or Article 9(4) is absent, false or incomplete; (g) any other administrative requirement provided for in Article 7 or Article 9 is not fulfilled. 2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is withdrawn from the market. CHAPTER IX Compliance of services Article 23 Compliance of services 1. Member States shall establish, implement and periodically update adequate procedures in order to: (a) check the compliance of services with the requirements of this Directive, including the assessment referred to in Article 14 for which Article 19(2) shall apply mutatis mutandis; (b) follow up complaints or reports on issues relating to non-compliance of services with the accessibility requirements of this Directive; (c) verify that the economic operator has taken the necessary corrective action. 2. Member States shall designate the authorities responsible for the implementation of the procedures referred to in paragraph 1 with respect to the compliance of services. Member States shall ensure that the public is informed of the existence, responsibilities, identity, work and decisions of the authorities referred to in the first subparagraph. Those authorities shall make that information available in accessible formats upon request. CHAPTER X Accessibility requirements in other Union acts Article 24 Accessibility under other Union acts 1. As regards the products and services referred to in Article 2 of this Directive, the accessibility requirements set out in Annex I thereto shall constitute mandatory accessibility requirements within the meaning of Article 42(1) of Directive 2014/24/EU and of Article 60(1) of Directive 2014/25/EU. 2. Any product or service, the features, elements or functions of which comply with the accessibility requirements set out in Annex I to this Directive in accordance with Section VI thereof shall be presumed to fulfil the relevant obligations set out in Union acts other than this Directive, as regards accessibility, for those features, elements or functions, unless otherwise provided in those other acts. Article 25 Harmonised standards and technical specifications for other Union acts Conformity with harmonised standards and technical specifications or parts thereof which are adopted in accordance with Article 15, shall create a presumption of compliance with Article 24 in so far as those standards and technical specifications or parts thereof meet the accessibility requirements of this Directive. CHAPTER XI Delegated acts, implementing powers and final provisions Article 26 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 4(9) shall be conferred on the Commission for an indeterminate period of time from 27 June 2019. The power to adopt delegated acts referred to in Article 12(3) and Article 14(7) shall be conferred on the Commission for a period of five years from 27 June 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 4(9), Article 12(3) and Article 14(7) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 4(9), Article 12(3) and Article 14(7) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 27 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 28 Working Group The Commission shall establish a working group consisting of representatives of market surveillance authorities, authorities responsible for compliance of services and relevant stakeholders, including representatives of persons with disabilities organisations. The working group shall: (a) facilitate the exchange of information and best practices among the authorities and relevant stakeholders; (b) foster cooperation between authorities and relevant stakeholders on matters relating to the implementation of this Directive to improve coherence in the application of the accessibility requirements of this Directive and to monitor closely the implementation of Article 14; and (c) provide advice, in particular to the Commission, notably on the implementation of Article 4 and Article 14. Article 29 Enforcement 1. Member States shall ensure that adequate and effective means exist to ensure compliance with this Directive. 2. The means referred to in paragraph 1 shall include: (a) provisions whereby a consumer may take action under national law before the courts or before the competent administrative bodies to ensure that the national provisions transposing this Directive are complied with; (b) provisions whereby public bodies or private associations, organisations or other legal entities which have a legitimate interest, in ensuring that this Directive is complied with, may engage under national law before the courts or before the competent administrative bodies either on behalf or in support of the complainant, with his or her approval, in any judicial or administrative procedure provided for the enforcement of obligations under this Directive. 3. This Article shall not apply to procurement procedures which are subject to Directive 2014/24/EU or Directive 2014/25/EU. Article 30 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. 2. The penalties provided for shall be effective, proportionate and dissuasive. Those penalties shall also be accompanied by effective remedial action in case of non-compliance of the economic operator. 3. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them. 4. Penalties shall take into account the extent of the non-compliance, including its seriousness, and the number of units of non-complying products or services concerned, as well as the number of persons affected. 5. This Article shall not apply to procurement procedures which are subject to Directive 2014/24/EU or Directive 2014/25/EU. Article 31 Transposition 1. Member States shall adopt and publish, by 28 June 2022, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those measures to the Commission. 2. They shall apply those measures from 28 June 2025. 3. By way of derogation from paragraph 2 of this Article, Member States may decide to apply the measures regarding the obligations set out in Article 4(8) at the latest from 28 June 2027. 4. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 5. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive. 6. Member States using the possibility provided for in Article 4(4) shall communicate to the Commission the text of the main measures of national law which they adopt to that end and shall report to the Commission on the progress made in their implementation. Article 32 Transitional measures 1. Without prejudice to paragraph 2 of this Article, Member States shall provide for a transitional period ending on 28 June 2030 during which service providers may continue to provide their services using products which were lawfully used by them to provide similar services before that date. Service contracts agreed before 28 June 2025 may continue without alteration until they expire, but no longer than five years from that date. 2. Member States may provide that self-service terminals lawfully used by service providers for the provision of services before 28 June 2025 may continue to be used in the provision of similar services until the end of their economically useful life, but no longer than 20 years after their entry into use. Article 33 Report and review 1. By 28 June 2030, and every five years thereafter, the Commission shall submit to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions a report on the application of this Directive. 2. The reports shall, inter alia, address in the light of social, economic and technological developments the evolution of the accessibility of products and services, possible technology lock in or barriers to innovation and the impact of this Directive on economic operators and on persons with disabilities. The reports shall also assess whether the application of Article 4(4) has contributed to approximate diverging accessibility requirements of the built environment of passenger transport services, consumer banking services and customer service centres of shops of electronic communications service providers, where possible, with a view to allowing their progressive alignment to the accessibility requirements set out in Annex III. The reports shall also assess if the application of this Directive, in particular its voluntary provisions, has contributed to approximate accessibility requirements of the built environment constituting works falling within the scope of Directive 2014/23/EU of the European Parliament and of the Council (35), Directive 2014/24/EU and Directive 2014/25/EU. The reports shall also address the effects to the functioning of the internal market of the application of Article 14 of this Directive, including, where available, on the basis of information received in accordance with Article 14(8), as well as the exemptions for microenterprises. The reports shall conclude whether this Directive has achieved its objectives and whether it would be appropriate to include new products and services, or to exclude certain products or services from the scope of this Directive and they shall identify, where possible, areas for burden reduction with a view to a possible revision of this Directive. The Commission shall, if necessary, propose appropriate measures which could include legislative measures. 3. Member States shall communicate to the Commission in due time all the information necessary for the Commission to draw up such reports. 4. The Commission\u2019s reports shall take into account the views of the economic stakeholders and relevant non-governmental organisations, including organisations of persons with disabilities. Article 34 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 35 This Directive is addressed to the Member States. Done at Strasbourg, 17 April 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 303, 19.8.2016, p. 103. (2) Position of the European Parliament of 13 March 2019 (not yet published in the Official Journal) and decision of the Council of 9 April 2019. (3) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251). (4) Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1). (5) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36). (6) Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (OJ L 95, 15.4.2010, p. 1). (7) Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1). (8) Regulation (EC) No 261/2004 of the European Parliament and of the Council of 11 February 2004 establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, and repealing Regulation (EEC) No 295/91 (OJ L 46, 17.2.2004, p. 1). (9) Regulation (EC) No 1107/2006 of the European Parliament and of the Council of 5 July 2006 concerning the rights of disabled persons and persons with reduced mobility when travelling by air (OJ L 204, 26.7.2006, p. 1). (10) Regulation (EC) No 1371/2007 of the European Parliament and of the Council of 23 October 2007 on rail passengers\u2019 rights and obligations (OJ L 315, 3.12.2007, p. 14). (11) Regulation (EU) No 1177/2010 of the European Parliament and of the Council of 24 November 2010 concerning the rights of passengers when travelling by sea and inland waterway and amending Regulation (EC) No 2006/2004 (OJ L 334, 17.12.2010, p. 1). (12) Regulation (EU) No 181/2011 of the European Parliament and of the Council of 16 February 2011 concerning the rights of passengers in bus and coach transport and amending Regulation (EC) No 2006/2004 (OJ L 55, 28.2.2011, p. 1). (13) Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (OJ L 191, 18.7.2008, p. 1). (14) Directive (EU) 2017/1564 of the European Parliament and of the Council of 13 September 2017 on certain permitted uses of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled and amending Directive 2001/29/EC on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 242, 20.9.2017, p. 6). (15) Regulation (EU) 2017/1563 of the European Parliament and of the Council of 13 September 2017 on the cross-border exchange between the Union and third countries of accessible format copies of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled (OJ L 242, 20.9.2017, p. 1). (16) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). (17) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (18) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). (19) Regulation (EU) No 1025/2012 of 25 October 2012 of the European Parliament and of the Council on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (20) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (21) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (22) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (23) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (24) OJ L 123, 12.5.2016, p. 1. (25) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (26) OJ C 369, 17.12.2011, p. 14. (27) Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36). (28) Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66). (29) Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34). (30) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349). (31) Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35). (32) Directive 2014/92/EU of the European Parliament and of the Council of 23 July 2014 on the comparability of fees related to payment accounts, payment account switching and access to payment accounts with basic features (OJ L 257, 28.8.2014, p. 214). (33) Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (OJ L 267, 10.10.2009, p. 7). (34) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32). (35) Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (OJ L 94, 28.3.2014, p. 1). ANNEX I ACCESSIBILITY REQUIREMENTS FOR PRODUCTS AND SERVICES Section I General accessibility requirements related to all products covered by this directive in accordance with Article 2(1) Products must be designed and produced in such a way as to maximise their foreseeable use by persons with disabilities and shall be accompanied where possible in or on the product by accessible information on their functioning and on their accessibility features. 1. Requirements on the provision of information: (a) the information on the use of the product provided on the product itself (labelling, instructions and warning) shall be: (i) made available via more than one sensory channel; (ii) presented in an understandable way; (iii) presented to users in ways they can perceive; (iv) presented in fonts of adequate size and suitable shape, taking into account foreseeable conditions of use, and using sufficient contrast, as well as adjustable spacing between letters, lines and paragraphs; (b) the instructions for use of a product, where not provided on the product itself but made available through the use of the product or through other means such as a website, including the accessibility functions of the product, how to activate them and their interoperability with assistive solutions shall be publicly available when the product is placed on the market and shall: (i) be made available via more than one sensory channel; (ii) be presented in an understandable way; (iii) be presented to users in ways they can perceive; (iv) be presented in fonts of adequate size and suitable shape, taking into account foreseeable conditions of use and using sufficient contrast, as well as adjustable spacing between letters, lines and paragraphs; (v) with regard to content, be made available in text formats that can be used for generating alternative assistive formats to be presented in different ways and via more than one sensory channel; (vi) be accompanied by an alternative presentation of any non-textual content; (vii) include a description of the user interface of the product (handling, control and feedback, input and output) which is provided in accordance with point 2; the description shall indicate for each of the points in point 2 whether the product provides those features; (viii) include a description of the functionality of the product which is provided by functions aiming to address the needs of persons with disabilities in accordance with point 2; the description shall indicate for each of the points in point 2 whether the product provides those features; (ix) include a description of the software and hardware interfacing of the product with assistive devices; the description shall include a list of those assistive devices which have been tested together with the product. 2. User interface and functionality design: The product, including its user interface, shall contain features, elements and functions, that allow persons with disabilities to access, perceive, operate, understand and control the product by ensuring that: (a) when the product provides for communication, including interpersonal communication, operation, information, control and orientation, it shall do so via more than one sensory channel; this shall include providing alternatives to vision, auditory, speech and tactile elements; (b) when the product uses speech it shall provide alternatives to speech and vocal input for communication, operation control and orientation; (c) when the product uses visual elements it shall provide for flexible magnification, brightness and contrast for communication, information and operation, as well as ensure interoperability with programmes and assistive devices to navigate the interface; (d) when the product uses colour to convey information, indicate an action, require a response or identify elements, it shall provide an alternative to colour; (e) when the product uses audible signals to convey information, indicate an action, require a response or identify elements, it shall provide an alternative to audible signals; (f) when the product uses visual elements it shall provide for flexible ways of improving vision clarity; (g) when the product uses audio it shall provide for user control of volume and speed, and enhanced audio features including the reduction of interfering audio signals from surrounding products and audio clarity; (h) when the product requires manual operation and control, it shall provide for sequential control and alternatives to fine motor control, avoiding the need for simultaneous controls for manipulation, and shall use tactile discernible parts; (i) the product shall avoid modes of operation requiring extensive reach and great strength; (j) the product shall avoid triggering photosensitive seizures; (k) the product shall protect the user\u2019s privacy when he or she uses the accessibility features; (l) the product shall provide an alternative to biometrics identification and control; (m) the product shall ensure the consistency of the functionality and shall provide enough, and flexible amounts of, time for interaction; (n) the product shall provide software and hardware for interfacing with the assistive technologies; (o) the product shall comply with the following sector-specific requirements: (i) self-service terminals: \u2014 shall provide for text-to-speech technology; \u2014 shall allow for the use of personal headsets; \u2014 where a timed response is required, shall alert the user via more than one sensory channel; \u2014 shall give the possibility to extend the time given; \u2014 shall have an adequate contrast and tactilely discernible keys and controls when keys and controls are available; \u2014 shall not require an accessibility feature to be activated in order to enable a user who needs the feature to turn it on; \u2014 when the product uses audio or audible signals, it shall be compatible with assistive devices and technologies available at Union level, including hearing technologies such as hearing aids, telecoils, cochlear implants and assistive listening devices; (ii) e-readers shall provide for text-to-speech technology; (iii) consumer terminal equipment with interactive computing capability, used for the provision of electronic communications services: \u2014 shall, when such products have text capability in addition to voice, provide for the handling of real time text and support high fidelity audio; \u2014 shall, when they have video capabilities in addition to or in combination with text and voice, provide for the handling of total conversation including synchronised voice, real time text, and video with a resolution enabling sign language communication; \u2014 shall ensure effective wireless coupling to hearing technologies; \u2014 shall avoid interferences with assistive devices; (iv) consumer terminal equipment with interactive computing capability, used for accessing audio visual media services shall make available to persons with disabilities the accessibility components provided by the audiovisual media service provider, for user access, selection, control, and personalisation and for transmission to assistive devices. 3. Support services: Where available, support services (help desks, call centres, technical support, relay services and training services) shall provide information on the accessibility of the product and its compatibility with assistive technologies, in accessible modes of communication. Section II Accessibility requirements related to products in Article 2(1), except for the self-service terminals referred to in Article 2(1)(b) In addition to the requirements of Section I, the packaging and instructions of products covered by this Section shall be made accessible, in order to maximise their foreseeable use by persons with disabilities. This means that: (a) the packaging of the product including the information provided in it (e.g. about opening, closing, use, disposal), including, when provided, information about the accessibility characteristics of the product, shall be made accessible; and, when feasible, that accessible information shall be provided on the package; (b) the instructions for the installation and maintenance, storage and disposal of the product not provided on the product itself but made available through other means, such as a website, shall be publicly available when the product is placed on the market and shall comply with the following requirements: (i) be available via more than one sensory channel; (ii) be presented in an understandable way; (iii) be presented to users in ways they can perceive; (iv) be presented in fonts of adequate size and suitable shape, taking into account foreseeable conditions of use, and using sufficient contrast, as well as adjustable spacing between letters, lines and paragraphs; (v) content of instructions shall be made available in text formats that can be used for generating alternative assistive formats to be presented in different ways and via more than one sensory channel; and (vi) instructions containing any non-textual content shall be accompanied by an alternative presentation of that content. Section III General accessibility requirements related to all services covered by this Directive in accordance with Article 2(2) The provision of services in order to maximise their foreseeable use by persons with disabilities, shall be achieved by: (a) ensuring the accessibility of the products used in the provision of the service, in accordance with Section I of this Annex and, where applicable, Section II thereof; (b) providing information about the functioning of the service, and where products are used in the provision of the service, its link to these products as well as information about their accessibility characteristics and interoperability with assistive devices and facilities: (i) making the information available via more than one sensory channel; (ii) presenting the information in an understandable way; (iii) presenting the information to users in ways they can perceive; (iv) making the information content available in text formats that can be used to generate alternative assistive formats to be presented in different ways by the users and via more than one sensory channel; (v) presenting in fonts of adequate size and suitable shape, taking into account foreseeable conditions of use and using sufficient contrast, as well as adjustable spacing between letters, lines and paragraphs; (vi) supplementing any non-textual content with an alternative presentation of that content; and (vii) providing electronic information needed in the provision of the service in a consistent and adequate way by making it perceivable, operable, understandable and robust; (c) making websites, including the related online applications, and mobile device-based services, including mobile applications, accessible in a consistent and adequate way by making them perceivable, operable, understandable and robust; (d) where available, support services (help desks, call centres, technical support, relay services and training services) providing information on the accessibility of the service and its compatibility with assistive technologies, in accessible modes of communication. Section IV Additional accessibility requirements related to specific services The provision of services in order to maximise their foreseeable use by persons with disabilities, shall be achieved by including functions, practices, policies and procedures and alterations in the operation of the service targeted to address the needs of persons with disabilities and ensure interoperability with assistive technologies: (a) Electronic communications services, including emergency communications referred to in Article 109(2) of Directive (EU) 2018/1972: (i) providing real time text in addition to voice communication; (ii) providing total conversation where video is provided in addition to voice communication; (iii) ensuring that emergency communications using voice, text (including real time text) is synchronised and where video is provided is also synchronised as total conversation and is transmitted by the electronic communications service providers to the most appropriate PSAP. (b) Services providing access to audiovisual media services: (i) providing electronic programme guides (EPGs) which are perceivable, operable, understandable and robust and provide information about the availability of accessibility; (ii) ensuring that the accessibility components (access services) of the audiovisual media services such as subtitles for the deaf and hard of hearing, audio description, spoken subtitles and sign language interpretation are fully transmitted with adequate quality for accurate display, and synchronised with sound and video, while allowing for user control of their display and use. (c) Air, bus, rail and waterborne passenger transport services except for urban and suburban transport services and regional transport services: (i) ensuring the provision of information on the accessibility of vehicles, the surrounding infrastructure and the built environment and on assistance for persons with disabilities; (ii) ensuring the provision of information about smart ticketing (electronic reservation, booking of tickets, etc.), real-time travel information (timetables, information about traffic disruptions, connecting services, onwards travel with other transport modes, etc.), and additional service information (e.g. staffing of stations, lifts that are out of order or services that are temporarily unavailable). (d) Urban and suburban transport services and regional transport services: ensuring the accessibility of self-service terminals used in the provision of the service in accordance with Section I of this Annex. (e) Consumer banking services: (i) providing identification methods, electronic signatures, security, and payment services which are perceivable, operable, understandable and robust; (ii) ensuring that the information is understandable, without exceeding a level of complexity superior to level B2 (upper intermediate) of the Council of Europe\u2019s Common European Framework of Reference for Languages. (f) E-books: (i) ensuring that, when an e-book contains audio in addition to text, it then provides synchronised text and audio; (ii) ensuring that e-book digital files do not prevent assistive technology from operating properly; (iii) ensuring access to the content, the navigation of the file content and layout including dynamic layout, the provision of the structure, flexibility and choice in the presentation of the content; (iv) allowing alternative renditions of the content and its interoperability with a variety of assistive technologies, in such a way that it is perceivable, understandable, operable and robust; (v) making them discoverable by providing information through metadata about their accessibility features; (vi) ensuring that digital rights management measures do not block accessibility features. (g) E-Commerce services: (i) providing the information concerning accessibility of the products and services being sold when this information is provided by the responsible economic operator; (ii) ensuring the accessibility of the functionality for identification, security and payment when delivered as part of a service instead of a product by making it perceivable, operable, understandable and robust; (iii) providing identification methods, electronic signatures, and payment services which are perceivable, operable, understandable and robust. Section V Specific accessibility requirements related to the answering of emergency communications to the single European emergency number \u2018112\u2019 by the most appropriate PSAP In order to maximise their foreseeable use by persons with disabilities, the answering of emergency communications to the single European emergency number \u2018112\u2019 by the most appropriate PSAP, shall be achieved by including functions, practices, policies and procedures and alterations targeted to address the needs of persons with disabilities. Emergency communications to the single European emergency number \u2018112\u2019 shall be appropriately answered, in the manner best suited to the national organisation of emergency systems, by the most appropriate PSAP using the same communication means as received, namely by using synchronised voice and text (including real time text), or, where video is provided, voice, text (including real time text) and video synchronised as total conversation. Section VI Accessibility requirements for features, elements or functions of products and services in accordance with Article 24(2) The presumption to fulfil the relevant obligations set out in other Union acts concerning features, elements or functions of products and services requires the following: 1. Products: (a) the accessibility of the information concerning the functioning and accessibility features related to products complies with the corresponding elements set out in point 1 of Section I of this Annex, namely information on the use of the product provided on the product itself and the instructions for use of a product, not provided in the product itself but made available through the use of the product or other means such as a website; (b) the accessibility of features, elements and functions of the user interface and the functionality design of products complies with the corresponding accessibility requirements of such user interface or functionality design set out in point 2 of Section I of this Annex; (c) the accessibility of the packaging, including the information provided in it and instructions for the installation and maintenance, storage and disposal of the product not provided in the product itself but made available through other means such as a website, except for self-service terminals complies with the corresponding accessibility requirements set out in Section II of this Annex. 2. Services: the accessibility of the features, elements and functions of services complies with the corresponding accessibility requirements for those features, elements and functions set out in the services-related Sections of this Annex. Section VII Functional performance criteria In order to maximise the foreseeable use by persons with disabilities, when the accessibility requirements, set out in Sections I to VI of this Annex, do not address one or more functions of the design and production of products or the provision of services those functions or means shall be accessible by complying with the related functional performance criteria. Those functional performance criteria may only be used as an alternative to one or more specific technical requirements, when these are referred to in the accessibility requirements, if and only if the application of the relevant functional performance criteria complies with the accessibility requirements and it determines that the design and production of products and the provision of services results in equivalent or increased accessibility for the foreseable use by persons with disabilities. (a) Usage without vision Where the product or service provides visual modes of operation, it shall provide at least one mode of operation that does not require vision. (b) Usage with limited vision Where the product or service provides visual modes of operation, it shall provide at least one mode of operation that enables users to operate the product with limited vision. (c) Usage without perception of colour Where the product or service provides visual modes of operation, it shall provide at least one mode of operation that does not require user perception of colour. (d) Usage without hearing Where the product or service provides auditory modes of operation, it shall provide at least one mode of operation that does not require hearing. (e) Usage with limited hearing Where the product or service provides auditory modes of operation, it shall provide at least one mode of operation with enhanced audio features that enables users with limited hearing to operate the product. (f) Usage without vocal capability Where the product or service requires vocal input from users, it shall provide at least one mode of operation that does not require vocal input. Vocal input includes any orally-generated sounds like speech, whistles or clicks. (g) Usage with limited manipulation or strength Where the product or service requires manual actions, it shall provide at least one mode of operation that enables users to make use of the product through alternative actions not requiring fine motor control and manipulation, hand strength or operation of more than one control at the same time. (h) Usage with limited reach The operational elements of products shall be within reach of all users. Where the product or service provides a manual mode of operation, it shall provide at least one mode of operation that is operable with limited reach and limited strength. (i) Minimising the risk of triggering photosensitive seizures Where the product provides visual modes of operation, it shall avoid modes of operation that trigger photosensitive seizures. (j) Usage with limited cognition The product or service shall provide at least one mode of operation incorporating features that make it simpler and easier to use. (k) Privacy Where the product or service incorporates features that are provided for accessibility, it shall provide at least one mode of operation that maintains privacy when using those features that are provided for accessibility. ANNEX II INDICATIVE NON-BINDING EXAMPLES OF POSSIBLE SOLUTIONS THAT CONTRIBUTE TO MEETING THE ACCESSIBILITY REQUIREMENTS IN ANNEX I SECTION I: EXAMPLES RELATED TO GENERAL ACCESSIBILITY REQUIREMENTS FOR ALL PRODUCTS COVERED BY THIS DIRECTIVE IN ACCORDANCE WITH ARTICLE 2(1) REQUIREMENTS IN SECTION I OF ANNEX I EXAMPLES 1. The provision of information (a) (i) Providing visual and tactile information or visual and auditory information indicating the place where to introduce a card in a self-service terminal so that blind persons and deaf persons can use the terminal. (ii) Using the same words in a consistent manner, or in a clear and logical structure, so that persons with intellectual disabilities can better understand it. (iii) Providing tactile relief format or sound in addition to a text warning so that blind persons can perceive it. (iv) Allowing that text can be read by persons who are visually impaired. (b) (i) Providing electronic files which can be read by a computer using screen readers so that blind persons can use the information. (ii) Using the same words in a consistent manner, or in a clear and logical structure, so that persons with intellectual disabilities can better understand them. (iii) Providing subtitles when video instructions are provided. (iv) Allowing that the text can be read by persons who are visually impaired. (v) Printing in Braille, so that a blind person can use them. (vi) Accompanying a diagram with a text description identifying the main elements or describing key actions. (vii) No example provided (viii) No example provided (ix) Including a socket and software in automated teller machines which will allow the plugging of a headphone which will receive the text on the screen in the form of sound. 2. User interface and functionality design (a) Providing instructions in the form of voice and text, or by incorporating tactile signs in a keypad, so that persons who are blind or hard of hearing can interact with the product. (b) Offering in a self-service terminal in addition to the spoken instructions, for example, instructions in the form of text or images so that deaf persons can also perform the action required (c) Allowing users to enlarge a text, to zoom in on a particular pictogram or to increase the contrast, so that persons who are visually impaired can perceive the information. (d) In addition of giving a choice to press the green or the red button for selecting an option, providing in written on the buttons what the options are, in order to allow person who are colour blind to make the choice. (e) When a computer gives an error signal, providing a written text or an image indicating the error, so as to allow deaf persons to apprehend that an error is occurring. (f) Allowing for additional contrast in foreground images so that persons who have low vision can see them. (g) Allowing the user of a telephone to select the volume of the sound and reduce the interference with hearing aids so that persons who are hard of hearing can use the telephone. (h) Making touch screen buttons bigger and well separated so that persons with tremor can press them. (i) Ensuring that buttons to be pressed do not require much force so that persons who have motor impairments can use them. (j) Avoiding flickering images so that persons who get seizures are not at risk. (k) Allowing the use of headphones when spoken information is provided by automated teller machines. (l) As an alternative to fingerprint recognition, allowing users who cannot use their hands to select a password for locking and unlocking a phone. (m) Ensuring that the software reacts in a predictable way when a particular action is performed and providing enough time to enter a password so that is easy to use for persons with intellectual disabilities. (n) Offering a connection with a refreshable Braille display so that blind persons can use the computer. (o) Examples of sector-specific requirements (i) No example provided (ii) No example provided (iii) First indent Providing that a mobile phone should be able to handle real time text conversations so that persons who are hard of hearing can exchange information in an interactive way. (iii) Fourth indent Allowing the simultaneous use of video to display sign language and text to write a message, so that two deaf persons can communicate with each other or with a hearing person. (iv) Ensuring that subtitles are transmitted through the set top box for their use by deaf persons. 3. Support services: No example provided SECTION II: EXAMPLES RELATED TO ACCESSIBILITY REQUIREMENTS FOR PRODUCTS IN ARTICLE 2(1), EXCEPT FOR THE SELF-SERVICE TERMINALS REFERRED TO IN ARTICLE 2(1)(b) REQUIREMENTS IN SECTION II OF ANNEX I EXAMPLES Packaging and instructions of products (a) Indicating in the packaging that the phone contains accessibility features for persons with disabilities. (b) (i) Providing electronic files which can be read by a computer using screen readers so that blind persons can use the information. (ii) Using the same words in a consistent manner, or in a clear and logical structure, so that persons with intellectual disabilities can better understand it. (iii) Providing tactile relief format or sound when a text warning is present so that blind persons receive the warning. (iv) Providing that the text can be read by persons who are visually impaired. (v) Printing in Braille, so that a blind person can read it. (vi) Supplementing a diagram with a text description identifying the main elements or describing key actions. SECTION III: EXAMPLES RELATED TO GENERAL ACCESSIBILITY REQUIREMENTS FOR ALL SERVICES COVERED BY THIS DIRECTIVE IN ACCORDANCE WITH ARTICLE 2(2) REQUIREMENTS IN SECTION III OF ANNEX I EXAMPLES The provision of services (a) No example provided (b) (i) Providing electronic files which can be read by a computer using screen readers so that blind persons can use the information. (ii) Using the same words in a consistent manner or in a clear and logical structure so that persons with intellectual disabilities can better understand it. (iii) Including subtitles when a video with instructions is provided. (iv) Providing that a blind person can use a file by printing it in Braille. (v) Providing that the text can be read by persons who are visually impaired. (vi) Supplementing a diagram with a text description identifying the main elements or describing key actions. (vii) When a service provider offers a USB-key containing information about the service, providing that information is accessible. (c) Providing text description of pictures, making all functionality available from a keyboard, giving users enough time to read, making content appear and operate in a predictable way, and providing compatibility with assistive technologies, so that persons with diverse disabilities can read and interact with a website. (d) No example provided SECTION IV: EXAMPLES RELATED TO ADDITIONAL ACCESSIBILITY REQUIREMENTS FOR SPECIFIC SERVICES REQUIREMENTS IN SECTION IV OF ANNEX I EXAMPLES Specific services (a) (i) Providing that persons who are hard of hearing could write and receive text in an interactive manner and in real time. (ii) Providing that deaf persons can use sign language to communicate among themselves. (iii) Providing that a person who has speech and hearing impairments and chooses to use a combination of text, voice and video, knows that the communication is transmitted through the network to an emergency service. (b) (i) Providing that a blind person can select programmes on the television. (ii) Supporting the possibility to select, personalise and display \u2018access services\u2019 such as subtitles for deaf persons or persons who are hard of hearing, audio description, spoken subtitles and sign language interpretation, by providing means for effective wireless coupling to hearing technologies or by providing user controls to activate \u2018access services\u2019 for audiovisual media services at the same level of prominence as the primary media controls. (c) (i) No example provided (ii) No example provided (d) No example provided (e) (i) Making the identification dialogues on a screen readable by screen readers so that blind persons can use them. (ii) No example provided (f) (i) Providing that a person with dyslexia can read and hear the text at the same time. (ii) Enabling synchronized text and audio output or by enabling a refreshable Braille transcript. (iii) Providing that a blind person can access the index or change chapters. (iv) No example provided (v) Ensuring that information on their accessibility features is available in the electronic file so that persons with disabilities can be informed. (vi) Ensuring that there is no blocking, for example that technical protection measures, rights management information or interoperability issues do not prevent the text from being read aloud by the assistive devices, so that blind users can read the book. (g) (i) Ensuring that available information on the accessibility features of a product is not deleted. (ii) Making the payment service user interface available by voice so that blind persons can make online purchases independently. (iii) Making the identification dialogues on a screen readable by screen readers so that blind persons can use them. ANNEX III ACCESSIBILITY REQUIREMENTS FOR THE PURPOSE OF ARTICLE 4(4) CONCERNING THE BUILT ENVIRONMENT WHERE THE SERVICES UNDER THE SCOPE OF THIS DIRECTIVE ARE PROVIDED In order to maximise the foreseeable use in an independent manner by persons with disabilities of the built environment in which a service is provided and which is under the responsibility of the service provider, as referred to in Article 4(4), the accessibility of areas intended for public access shall include the following aspects: (a) use of related outdoor areas and facilities; (b) approaches to buildings; (c) use of entrances; (d) use of paths in horizontal circulation; (e) use of paths in vertical circulation; (f) use of rooms by the public; (g) use of equipment and facilities used in the provision of the service; (h) use of toilets and sanitary facilities; (i) use of exits, evacuation routes and concepts for emergency planning; (j) communication and orientation via more than one sensory channel; (k) use of facilities and buildings for their foreseeable purpose; (l) protection from hazards in the environment indoors and outdoors. ANNEX IV CONFORMITY ASSESSMENT PROCEDURE \u2013 PRODUCTS 1. Internal production control Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Annex, and ensures and declares on its sole responsibility that the product concerned satisfy the appropriate requirements of this Directive. 2. Technical documentation The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the product to the relevant accessibility requirements referred to in Article 4 and, in case the manufacturer relied on Article 14, to demonstrate that relevant accessibility requirements would introduce a fundamental alteration or impose a disproportionate burden. The technical documentation shall specify only the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements: (a) a general description of the product; (b) a list of the harmonised standards and technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the relevant accessibility requirements referred to in Article 4 where those harmonised standards or technical specifications have not been applied; in the event of partly applied harmonised standards or technical specifications, the technical documentation shall specify the parts which have been applied. 3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the products with the technical documentation referred to in point 2 of this Annex and with the accessibility requirements of this Directive. 4. CE marking and EU declaration of conformity 4.1. The manufacturer shall affix the CE marking referred to in this Directive to each individual product that satisfies the applicable requirements of this Directive. 4.2. The manufacturer shall draw up a written EU declaration of conformity for a product model. The EU declaration of conformity shall identify the product for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 5. Authorised representative The manufacturer\u2019s obligations set out in point 4 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate. ANNEX V INFORMATION ON SERVICES MEETING ACCESSIBILITY REQUIREMENTS 1. The service provider shall include the information assessing how the service meets the accessibility requirements referred to in Article 4 in the general terms and conditions, or equivalent document. The information shall describe the applicable requirements and cover, as far as relevant for the assessment the design and the operation of the service. In addition to the consumer information requirements of Directive 2011/83/EU, the information shall, where applicable, contain the following elements: (a) a general description of the service in accessible formats; (b) descriptions and explanations necessary for the understanding of the operation of the service; (c) a description of how the relevant accessibility requirements set out in Annex I are met by the service. 2. To comply with point 1 of this Annex the service provider may apply in full or in part the harmonised standards and technical specifications, for which references have been published in the Official Journal of the European Union. 3. The service provider shall provide information demonstrating that the service delivery process and its monitoring ensure compliance of the service with point 1 of this Annex and with the applicable requirements of this Directive. ANNEX VI CRITERIA FOR ASSESSMENT OF DISPROPORTIONATE BURDEN Criteria to carry out and document the assessment: 1. Ratio of the net costs of compliance with accessibility requirements to the overall costs (operating and capital expenditures) of manufacturing, distributing or importing the product or providing the service for the economic operators. Elements to use to assess the net costs of compliance with accessibility requirements: (a) criteria related to one-off organisational costs to take into account in the assessment: (i) costs related to additional human resources with accessibility expertise; (ii) costs related to training human resources and acquiring competences on accessibility; (iii) costs of development of a new process for including accessibility in the product development or service provision; (iv) costs related to development of guidance material on accessibility; (v) one-off costs of understanding the legislation on accessibility; (b) criteria related to on-going production and development costs to take into account in the assessment: (i) costs related to the design of the accessibility features of the product or service; (ii) costs incurred in the manufacturing processes; (iii) costs related to testing the product or service for accessibility; (iv) costs related to establishing documentation. 2. The estimated costs and benefits for the economic operators, including production processes and investments, in relation to the estimated benefit for persons with disabilities, taking into account the amount and frequency of use of the specific product or service. 3. Ratio of the net costs of compliance with accessibility requirements to the net turnover of the economic operator. Elements to use to assess the net costs of compliance with accessibility requirements: (a) criteria related to one-off organisational costs to take into account in the assessment: (i) costs related to additional human resources with accessibility expertise; (ii) costs related to training human resources and acquiring competences on accessibility; (iii) costs of development of a new process for including accessibility in the product development or service provision; (iv) costs related to development of guidance material on accessibility; (v) one off costs of understanding the legislation on accessibility; (b) criteria related to on-going production and development costs to take into account in the assessment: (i) costs related to the design of the accessibility features of the product or service; (ii) costs incurred in the manufacturing processes; (iii) costs related to testing the product or service for accessibility; (iv) costs related to establishing documentation.", "summary": "Accessibility of products and services Accessibility of products and services SUMMARY OF: Directive (EU) 2019/882 on the accessibility requirements for products and services WHAT IS THE AIM OF THE DIRECTIVE? It aims to harmonise accessibility* requirements for certain products* and services so the EU\u2019s internal market operates smoothly by eliminating and preventing any free-movement barriers that may exist because of divergent national legislation. It aims to bring benefits to businesses, people with disabilities* and the elderly. Applying accessibility requirements will clarify the existing accessibility obligation in EU law, particularly in public procurement and structural funds. It is known as the European accessibility act. KEY POINTS The legislation will apply from 28 June 2025 to the following. Products: computers and operating systems;payment terminals and certain self-service terminals such as ATMs, ticketing and check-in machines, interactive self-service information terminals;smartphones and other equipment for accessing telecommunication services;TV equipment involving digital television services;e-readers. Services: telephony services;services to access audiovisual media services;certain elements of air, bus, rail and water transport services such as websites, mobile services, electronic tickets, information;consumer banking;e-books;e-commerce;answer to emergency calls to the single European number \u2018112\u2019. The legislation does not apply to: pre-recorded time-based media, such as videos and slides or office file formats published before 28 June 2025; online maps if essential information is provided in an accessible digital way; websites and other forms of archive containing content not updated or edited after 28 June 2025; microenterprises providing services. Specific accessibility requirements apply to all products and services covered by the legislation, provided these do not alter their basic nature or impose a disproportionate burden on operators. Products must: be designed and produced to maximise their use by people with disabilities; comply with detailed rules on information and instructions, user interface and functionality design, support services and packaging. Services must: provide information about the service, its accessibility features and facilities; make websites and mobile devices easily accessible; support systems, such as help desks, call centres and training to provide information on accessibility; apply practices, policies and procedures to address the needs of people with disabilities. Specific rules apply to different services (electronic communications, audiovisual, air, bus, rail, water and urban transport, consumer banking, e-books, e-commerce and the answering to emergency 112 phone number). EU countries may decide to require the compliance of the built environment where services are provided with accessibility requirements. Annex II provides non-binding examples of how the various accessibility requirements may be met. The legislation requires the following. Manufacturers must: design and manufacture products according to the directive, taking into account any subsequent changes in the harmonised standards;draw up the necessary technical documentation, carry out the conformity procedure and keep the information for 5 years;provide clear identification on their products and their own contact details;accompany the product with easily understood instructions and safety information. Importers must: ensure the product has passed the conformity assessment procedure, has the necessary technical documentation, including instructions in a language users can easily understand, and bears the CE marking;refuse to place on the market a product they believe does not meet the accessibility requirements and to inform the manufacturer and market surveillance authorities. Service providers must: design and provide services according to the directive;make available to the public written and oral information easily accessible to people with disabilities on the service they offer and how this meets the accessibility requirements;ensure procedures are in place to continue conforming with the accessibility requirements and take into account any changes. Manufacturers, importers and distributors must act immediately if they discover the product no longer complies with the legislation. EU countries must: ensure all products and services covered by the legislation comply with its accessibility requirements; on request supply the public with information on how companies implement the requirements; implement and update procedures to: check the compliance of services with the directive,follow up complaints or reports on non-compliance,verify that the company has remedied the failing; provide ways, including legal action, to ensure compliance and penalties for any breach of the law. The European Commission: may adopt delegated and implementing acts to amend technical aspects of the directive; may request the European standardisation organisations to draft harmonised standards on accessibility requirements or adopt technical specifications under certain conditions; establishes a working group of representatives of authorities for market surveillance and services\u2019 compliance and of stakeholders including disability organisations to: promote exchange of information and best practice,foster cooperation between authorities and stakeholders,provide advice; submits, by 28 June 2030 and every 5 years thereafter, a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of the legislation. FROM WHEN DOES THE DIRECTIVE APPLY? It has to become law in the EU countries by 28 June 2022. EU countries must apply the measures from 28 June 2025. However, EU countries may: delay compliance for the European emergency 112 number until 28 June 2027; give service providers whose facilities were already lawfully in use by 28 June 2025 a further 5 years (until 28 June 2030); allow self-service terminals to operate until the end of their economically useful life, but no longer than 20 years after entering service. BACKGROUND Over 80 million people in the EU live with some kind of disability. With an ageing society, the number is increasing. The EU\u2019s Charter of Fundamental Rights recognises and respects the right of persons with disabilities to benefit from measures designed to ensure their independence, social and occupational integration and participation in the life of the community. The directive defines people with disabilities in line with the United Nations Convention on the Rights of Persons with Disabilities which has been ratified by all EU countries. KEY TERMS Accessibility: design of products, devices, services or environments to be used by people with disabilities on equal basis with others. Products: a substance, preparation or good produced through a manufacturing process (other than food, feed, living plants and animals or products of human, plant and animal origin for future reproduction). Person with disabilities: someone with long-term physical, mental, intellectual or sensory impairment which in interaction with various barriers may hinder their full, effective participation in society on equal basis with others. MAIN DOCUMENT Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, pp. 70-115) RELATED DOCUMENTS Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (recast) (OJ L 321, 17.12.2018, pp. 36-214) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82-128) last update 10.09.2019"}
{"article": "19.5.2017 EN Official Journal of the European Union L 130/1 REGULATION (EU) 2017/821 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2017 laying down supply chain due diligence obligations for Union importers of tin, tantalum and tungsten, their ores, and gold originating from conflict-affected and high-risk areas THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national Parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Although they hold great potential for development, natural mineral resources can, in conflict-affected or high-risk areas, be a cause of dispute where their revenues fuel the outbreak or continuation of violent conflict, undermining endeavours towards development, good governance and the rule of law. In those areas, breaking the nexus between conflict and illegal exploitation of minerals is a critical element in guaranteeing peace, development and stability. (2) The challenge posed by the desire to prevent the financing of armed groups and security forces in resource-rich areas has been taken up by governments and international organisations together with economic operators and civil society organisations, including women's organisations that are to the forefront of drawing attention to the exploitative conditions imposed by these groups and forces, as well as to rape and violence used to control local populations. (3) Human rights abuses are common in resource-rich conflict-affected and high-risk areas and may include child labour, sexual violence, the disappearance of people, forced resettlement and the destruction of ritually or culturally significant sites. (4) The Union has been actively engaged in an initiative of the Organisation for Economic Co-operation and Development (OECD) to advance the responsible sourcing of minerals from conflict areas, which has resulted in a government-backed multi-stakeholder process leading to the adoption of the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (\u2018OECD Due Diligence Guidance\u2019) including the Annexes and Supplements thereto. In May 2011, the OECD Ministerial Council recommended the active promotion of the observance of that Guidance. (5) The concept of responsible sourcing is referred to in the updated OECD Guidelines for Multinational Enterprises (2) and is in line with the UN Guiding Principles on Business and Human Rights (3). Those documents aim to advance supply chain due diligence practices when businesses source from areas affected by conflict and instability. At the highest international level, UN Security Council Resolution 1952 (2010) specifically targeted the Democratic Republic of Congo (the DRC) and its neighbours in Central Africa calling for supply chain due diligence to be observed. Following up on that Resolution, the UN Group of Experts on the DRC also advocated compliance with the OECD Due Diligence Guidance. (6) In addition to multilateral initiatives, on 15 December 2010, the Heads of State and Government of the African Great Lakes Region took a political commitment in Lusaka to fight the illegal exploitation of natural resources in the region and approved, inter alia, a regional certification mechanism based on the OECD Due Diligence Guidance. (7) This Regulation, by controlling trade in minerals from conflict areas, is one of the ways of eliminating the financing of armed groups. The Union's foreign and development policy action also contributes to fighting local corruption, to the strengthening of borders and to providing training for local populations and their representatives in order to help them highlight abuses. (8) In its communication of 4 November 2008 entitled \u2018The raw materials initiative \u2014 meeting our critical needs for growth and jobs in Europe\u2019, the Commission recognised that securing reliable and undistorted access to raw materials is an important factor for the Union's competitiveness. The raw materials initiative contained in that Commission communication is an integrated strategy aimed at responding to different challenges related to access to non-energy and non-agriculture raw materials. That initiative recognises and promotes financial as well as supply chain transparency, and the application of corporate social responsibility standards. (9) In its resolutions of 7 October 2010, of 8 March 2011, of 5 July 2011 and of 26 February 2014, the European Parliament called for the Union to legislate along the lines of the US law on conflict minerals, Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act. In its communications of 2 February 2011 entitled \u2018Tackling the challenges in commodity markets and on raw materials\u2019 and of 27 January 2012 entitled \u2018Trade, growth and development \u2014 Tailoring trade and investment policy for those countries most in need\u2019, the Commission announced its intention to explore ways of improving transparency throughout the supply chain, including aspects of due diligence. In the latter communication and in line with the commitment made by it at the May 2011 OECD Ministerial Council, the Commission also advocated greater support for and use of the OECD Guidelines for Multinational Enterprises, and of the OECD Due Diligence Guidance, even outside the OECD membership. (10) Union citizens and civil society actors have raised awareness with respect to Union economic operators not being held accountable for their potential connection to the illicit extraction of and trade in minerals from conflict areas. Such minerals, potentially present in consumer products, link consumers to conflicts outside the Union. As such, consumers are indirectly linked to conflicts that have severe impacts on human rights, in particular the rights of women, as armed groups often use mass rape as a deliberate strategy to intimidate and control local populations in order to preserve their interests. For this reason, Union citizens have requested, in particular through petitions, that the Commission make a legislative proposal to the European Parliament and to the Council to hold economic operators accountable under the relevant Guidelines as established by the UN and OECD. (11) In the context of this Regulation, and as set out in the OECD Due Diligence Guidance, supply chain due diligence is an ongoing, proactive and reactive process through which economic operators monitor and administer their purchases and sales with a view to ensuring that they do not contribute to conflict or the adverse impacts thereof. (12) Third-party auditing of an economic operator's supply chain due diligence practices ensures credibility for the benefit of downstream economic operators and contributes to the improvement of upstream due diligence practices. (13) Public reporting by an economic operator on its supply chain due diligence policies and practices provides the necessary transparency to generate public confidence in the measures economic operators are taking. (14) Union importers retain individual responsibility to comply with the due diligence obligations set out in this Regulation. However, many existing and future supply chain due diligence schemes (\u2018due diligence schemes\u2019) could contribute to achieving the aims of this Regulation. Due diligence schemes that are aimed at breaking the link between conflict and the sourcing of tin, tantalum, tungsten and gold already exist. Such schemes use independent third-party audits to certify smelters and refiners that have systems in place to ensure the responsible sourcing of minerals. It should be possible to recognise those schemes in the Union system for supply chain due diligence (\u2018Union system\u2019). The methodology and criteria for such schemes to be recognised as equivalent to the requirements of this Regulation should be established in a delegated act to allow for compliance with this Regulation by individual economic operators that are members of those schemes and to avoid double auditing. Such schemes should incorporate the overarching due diligence principles, ensure that requirements are aligned to the specific recommendations of the OECD Due Diligence Guidance and meet the procedural requirements such as stakeholders' engagement, grievance mechanisms and responsiveness. (15) Union economic operators have, through public consultations, expressed their interest in the responsible sourcing of minerals and reported on current due diligence schemes designed to pursue their corporate social responsibility objectives, customer requests, or the security of their supplies. However, Union economic operators have also reported countless difficulties and practical challenges in the exercise of supply chain due diligence because of lengthy and complex global supply chains involving a high number of economic operators that are often insufficiently aware or ethically unconcerned. The Commission should review the cost of responsible sourcing and of third-party auditing, the administrative consequences of such sourcing and auditing and their potential impact on competitiveness, in particular that of small and medium-sized enterprises (SMEs), and should report its findings to the European Parliament and to the Council. The Commission should ensure that micro, small and medium-sized enterprises benefit from adequate technical assistance and should facilitate the exchange of information in order to implement this Regulation. Micro, small and medium-sized enterprises established in the Union which import minerals and metals should therefore benefit from the COSME programme established by Regulation (EU) No 1287/2013 of the European Parliament and of the Council (4). (16) Smelters and refiners are an important stage in global mineral supply chains as they are typically the last stage in which due diligence can effectively be assured by collecting, disclosing and verifying information on the mineral's origin and chain of custody. After this stage of transformation, it is often considered to be unfeasible to trace back the origins of minerals. The same applies to recycled metals, which have undergone even further steps in the transformation process. A Union list of global responsible smelters and refiners could therefore provide transparency and certainty to downstream economic operators as regards supply chain due diligence practices. In accordance with the OECD Due Diligence Guidance, upstream economic operators such as smelters and refiners should undergo an independent third-party audit of their supply chain due diligence practices, with a view to also being included in the list of global responsible smelters and refiners. (17) It is essential that Union importers of minerals and metals who fall within the scope of this Regulation comply with its provisions, including Union smelters and refiners which import and process minerals and concentrates thereof. (18) To ensure the proper functioning of the Union system while guaranteeing that the vast majority of minerals and metals falling within the scope of this Regulation and imported into the Union are subject to its requirements, this Regulation should not apply in situations where the Union importers' annual import volumes of each mineral or metal concerned are below the volume thresholds listed in Annex I to this Regulation. (19) In order to ensure the proper functioning of the Union system and to facilitate the assessment of due diligence schemes that might be recognised under this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annex I to this Regulation by establishing and amending the volume thresholds of minerals and metals and in respect of setting out the methodology and criteria to be followed for that assessment acknowledging, in this regard, the work of the OECD. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (5). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (20) Member State competent authorities should be responsible for ensuring the uniform compliance of Union importers of minerals or metals who fall within the scope of this Regulation by carrying out appropriate ex-post checks. Records of such checks should be kept for at least five years. Member States should be required to establish the rules applicable to infringements of this Regulation. (21) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. The implementing powers relating to the recognition of due diligence schemes as equivalent, the withdrawal of equivalence in the case of deficiencies, as well as the establishment of the list of global responsible smelters and refiners should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). In view of the nature of those implementing acts, given the limited discretionary powers of the Commission, whereby those acts should be based on the methodology and criteria to be adopted by means of a delegated act for the recognition of due diligence schemes by the Commission, the advisory procedure is considered to be the appropriate procedure for the adoption of those implementing acts. (22) In order to guarantee the efficient implementation of this Regulation, provision should be made for a transitional period to allow for, inter alia, the establishment of Member States' competent authorities, for the Commission to recognise due diligence schemes and for economic operators to become familiar with their obligations under this Regulation. (23) The Commission and the High Representative of the Union for Foreign Affairs and Security Policy should regularly review their financial assistance to and political commitments with regard to conflict-affected and high-risk areas where tin, tantalum, tungsten and gold are mined, in particular in the African Great Lakes Region, in order to ensure policy coherence, and in order to incentivise and strengthen the respect for good governance, the rule of law and ethical mining. (24) The Commission should report regularly to the European Parliament and to the Council on the effects of the Union system laid down by this Regulation. By 1 January 2023 and every three years thereafter, the Commission should review the functioning and the effectiveness of the Union system, and its impact on the ground as regards the promotion of responsible sourcing of the minerals falling within the scope of this Regulation from conflict-affected and high-risk areas and on Union economic operators including SMEs, and should report to the European Parliament and to the Council. Those reports may be accompanied, if necessary, by appropriate legislative proposals, which may include further mandatory measures. (25) In their Joint Communication of 5 March 2014 entitled \u2018Responsible sourcing of minerals originating in conflict-affected and high-risk areas: Towards an integrated EU approach\u2019 (the \u2018Joint Communication of 5 March 2014\u2019), the Commission and the High Representative of the Union for Foreign Affairs and Security Policy committed to the implementation of accompanying measures leading to an integrated Union approach to responsible sourcing in parallel with this Regulation, with the aim not only of reaching a high level of participation by economic operators in the Union system provided for in this Regulation but also ensuring that a global, coherent and comprehensive approach is taken to promote responsible sourcing from conflict-affected and high-risk areas. (26) Preventing the profits from the trade in minerals and metals being used to fund armed conflict through due diligence and transparency will promote good governance and sustainable economic development. Therefore, this Regulation incidentally covers areas falling within the Union policy in the field of development cooperation in addition to the predominant area covered which falls under the common commercial policy of the Union, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. This Regulation establishes a Union system for supply chain due diligence (\u2018Union system\u2019) in order to curtail opportunities for armed groups and security forces to trade in tin, tantalum and tungsten, their ores, and gold. This Regulation is designed to provide transparency and certainty as regards the supply practices of Union importers, and of smelters and refiners sourcing from conflict-affected and high-risk areas. 2. This Regulation lays down the supply chain due diligence obligations of Union importers of minerals or metals containing or consisting of tin, tantalum, tungsten or gold, as set out in Annex I. 3. This Regulation shall not apply to Union importers of minerals or metals where their annual import volume of each of the minerals or metals concerned is below the volume thresholds set out in Annex I. All volume thresholds are set at a level that ensures that the vast majority, but no less than 95 %, of the total volumes imported into the Union of each mineral and metal under the Combined Nomenclature code is subject to the obligations of Union importers set out in this Regulation. 4. The Commission shall adopt a delegated act, in accordance with Articles 18 and 19, if feasible by 1 April 2020 but no later than 1 July 2020, to amend Annex I by establishing the volume thresholds for tantalum or niobium ores and concentrates, gold ores and concentrates, tin oxides and hydroxides, tantalates and carbides of tantalum. 5. The Commission is empowered to adopt delegated acts in accordance with Articles 18 and 19 to amend the existing thresholds listed in Annex I every three years after 1 January 2021. 6. With the exception of Article 7(4), this Regulation shall not apply to recycled metals. 7. This Regulation shall not apply to stocks where a Union importer demonstrates that those stocks were created in the current form on a verifiable date prior to 1 February 2013. 8. This Regulation shall apply to minerals and metals referred to in Annex I that are obtained as by-products as defined in Article 2(t). Article 2 Definitions For the purpose of this Regulation, the following definitions apply: (a) \u2018minerals\u2019 means the following, as listed in Part A of Annex I: \u2014 ores and concentrates containing tin, tantalum or tungsten, and \u2014 gold; (b) \u2018metals\u2019 means metals containing or consisting of tin, tantalum, tungsten or gold, as listed in Part B of Annex I; (c) \u2018mineral supply chain\u2019 means the system of activities, organisations, actors, technology, information, resources and services involved in moving and processing the minerals from the extraction site to their incorporation in the final product; (d) \u2018supply chain due diligence\u2019 means the obligations of Union importers of tin, tantalum and tungsten, their ores, and gold in relation to their management systems, risk management, independent third-party audits and disclosure of information with a view to identifying and addressing actual and potential risks linked to conflict-affected and high-risk areas to prevent or mitigate adverse impacts associated with their sourcing activities; (e) \u2018chain of custody or supply chain traceability system\u2019 means a record of the sequence of economic operators which have custody of minerals and metals as they move through a supply chain; (f) \u2018conflict-affected and high-risk areas\u2019 means areas in a state of armed conflict or fragile post-conflict as well as areas witnessing weak or non-existent governance and security, such as failed states, and widespread and systematic violations of international law, including human rights abuses; (g) \u2018armed groups and security forces\u2019 means groups referred to in Annex II to the OECD Due Diligence Guidance; (h) \u2018smelter and refiner\u2019 means any natural or legal person performing forms of extractive metallurgy involving processing steps with the aim to produce a metal from a mineral; (i) \u2018global responsible smelters and refiners\u2019 means smelters and refiners located inside or outside the Union that are deemed to fulfil the requirements of this Regulation; (j) \u2018upstream\u2019 means the mineral supply chain from the extraction sites to the smelters and refiners, inclusive; (k) \u2018downstream\u2019 means the metal supply chain from the stage following the smelters and refiners to the final product; (l) \u2018Union importer\u2019 means any natural or legal person declaring minerals or metals for release for free circulation within the meaning of Article 201 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (7) or any natural or legal person on whose behalf such declaration is made, as indicated in data elements 3/15 and 3/16 in accordance with Annex B to Commission Delegated Regulation (EU) 2015/2446 (8); (m) \u2018supply chain due diligence scheme\u2019 or \u2018due diligence scheme\u2019 means a combination of voluntary supply chain due diligence procedures, tools and mechanisms, including independent third-party audits, developed and overseen by governments, industry associations or groupings of interested organisations; (n) \u2018Member State competent authorities\u2019 means authorities designated by Member States in accordance with Article 10 with expertise as regards raw materials, industrial processes and auditing; (o) \u2018OECD Due Diligence Guidance\u2019 means the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (Second Edition, OECD 2013), including all its Annexes and Supplements; (p) \u2018grievance mechanism\u2019 means an early-warning risk awareness mechanism allowing any interested party, including whistle-blowers, to voice concerns regarding the circumstances of extraction, trade and handling of minerals in and export of minerals from conflict-affected and high-risk areas; (q) \u2018model supply chain policy\u2019 means a supply chain policy that conforms to Annex II to the OECD Due Diligence Guidance outlining the risks of significant adverse impacts which may be associated with the extraction, trade, and handling of minerals in and export of minerals from conflict-affected and high-risk areas; (r) \u2018risk management plan\u2019 means the written response of a Union importer to the identified supply chain risks based on Annex III to the OECD Due Diligence Guidance; (s) \u2018recycled metals\u2019 means reclaimed end-user or post-consumer products, or scrap processed metals created during product manufacturing, including excess, obsolete, defective, and scrap metal materials which contain refined or processed metals that are appropriate for recycling in the production of tin, tantalum, tungsten or gold. For the purposes of this definition, minerals partially processed, unprocessed or a by-product from another ore are not considered to be recycled metals; (t) \u2018by-product\u2019 means a mineral or metal falling within the scope of this Regulation that has been obtained from the processing of a mineral or metal falling outside the scope of this Regulation, and which would not have been obtained without the processing of the primary mineral or metal falling outside the scope of this Regulation; (u) \u2018verifiable date\u2019 means a date which can be verified by the inspection of physical date stamps on products or of inventory lists. Article 3 Compliance of Union importers with supply chain due diligence obligations 1. Union importers of minerals or metals shall comply with the supply chain due diligence obligations set out in this Regulation and shall keep documentation demonstrating their respective compliance with those obligations, including the results of the independent third-party audits. 2. Member State competent authorities shall be responsible for carrying out appropriate ex-post checks pursuant to Article 11. 3. Pursuant to Article 8(1), interested parties may submit supply chain due diligence schemes for recognition by the Commission with a view to facilitating the compliance of Union importers with the relevant requirements set out in Articles 4 to 7. Article 4 Management system obligations Union importers of minerals or metals shall: (a) adopt, and clearly communicate to suppliers and the public up-to-date information on, their supply chain policy for the minerals and metals potentially originating from conflict-affected and high-risk areas; (b) incorporate in their supply chain policy standards against which supply chain due diligence is to be conducted consistent with the standards set out in the model supply chain policy in Annex II to the OECD Due Diligence Guidance; (c) structure their respective internal management systems to support supply chain due diligence by assigning responsibility to senior management, in cases where the Union importer is not a natural person, to oversee the supply chain due diligence process as well as maintain records of those systems for a minimum of five years; (d) strengthen their engagement with suppliers by incorporating their supply chain policy into contracts and agreements with suppliers consistent with Annex II to the OECD Due Diligence Guidance; (e) establish a grievance mechanism as an early-warning risk-awareness system or provide such mechanism through collaborative arrangements with other economic operators or organisations, or by facilitating recourse to an external expert or body, such as an ombudsman; (f) as regards minerals, operate a chain of custody or supply chain traceability system that provides, supported by documentation, the following information: (i) description of the mineral, including its trade name and type; (ii) name and address of the supplier to the Union importer; (iii) country of origin of the minerals; (iv) quantities and dates of extraction, if available, expressed in volume or weight; (v) where minerals originate from conflict-affected and high-risk areas or, where other supply chain risks as listed in the OECD Due Diligence Guidance have been ascertained by the Union importer, additional information in accordance with the specific recommendations for upstream economic operators, as set out in the OECD Due Diligence Guidance, such as the mine of mineral origin, locations where minerals are consolidated, traded and processed, and taxes, fees and royalties paid; (g) as regards metals, operate a chain of custody or supply chain traceability system that provides, supported by documentation, the following information: (i) description of the metal, including its trade name and type; (ii) name and address of the supplier to the Union importer; (iii) name and address of the smelters and refiners in the supply chain of the Union importer; (iv) if available, records of the third-party audit reports of the smelters and refiners, or evidence of conformity with a supply chain due diligence scheme recognised by the Commission pursuant to Article 8; (v) if the records referred to in point (iv) are not available: \u2014 countries of origin of the minerals in the supply chain of the smelters and refiners, \u2014 where metals are based on minerals originating from conflict-affected and high-risk areas, or other supply chain risks as listed in the OECD Due Diligence Guidance have been ascertained by the Union importer, additional information in accordance with the specific recommendations for downstream economic operators set out in that Guidance; (h) as regards by-products, provide information supported by documentation as from the point of origin of those by-products, namely the point where the by-product is first separated from its primary mineral or metal falling outside the scope of this Regulation. Article 5 Risk management obligations 1. Union importers of minerals shall: (a) identify and assess the risks of adverse impacts in their mineral supply chain on the basis of the information provided pursuant to Article 4 against the standards of their supply chain policy, consistent with Annex II to, and the due diligence recommendations set out in, the OECD Due Diligence Guidance; (b) implement a strategy to respond to the identified risks designed so as to prevent or mitigate adverse impacts by: (i) reporting findings of the supply chain risk assessment to senior management designated for that purpose, in cases where the Union importer is not a natural person; (ii) adopting risk management measures consistent with Annex II to, and the due diligence recommendations set out in, the OECD Due Diligence Guidance, considering their ability to influence, and where necessary take steps to exert pressure on suppliers who can most effectively prevent or mitigate the identified risk, by making it possible either to: \u2014 continue trade while simultaneously implementing measurable risk mitigation efforts, \u2014 suspend trade temporarily while pursuing ongoing measurable risk mitigation efforts, or \u2014 disengage with a supplier after failed attempts at risk mitigation; (iii) implementing the risk management plan; monitoring and tracking performance of risk mitigation efforts; reporting back to senior management designated for this purpose, in cases where the Union importer is not a natural person; and considering suspending or discontinuing engagement with a supplier after failed attempts at mitigation; (iv) undertaking additional fact and risk assessments for risks requiring mitigation, or after a change of circumstances. 2. If a Union importer of minerals pursues risk mitigation efforts while continuing trade or temporarily suspending trade, it shall consult with suppliers and with the stakeholders concerned, including local and central government authorities, international or civil society organisations and affected third parties, and agree on a strategy for measurable risk mitigation in the risk management plan. 3. Union importers of minerals shall, in order to design conflict and high-risk sensitive strategies for mitigation in the risk management plan, rely on the measures and indicators referred to in Annex III to the OECD Due Diligence Guidance and measure progressive improvement. 4. Union importers of metals shall identify and assess, in accordance with Annex II to the OECD Due Diligence Guidance and the specific recommendations set out in that Guidance, the risks in their supply chain based on available third-party audit reports concerning the smelters and refiners in that chain, and, by assessing, as appropriate, the due diligence practices of those smelters and refiners. Those audit reports shall be in accordance with Article 6(1) of this Regulation. In the absence of such third-party audit reports from the smelters and refiners in their supply chain, Union importers of metals shall identify and assess the risks in their supply chain as part of their own risk management system. In such cases, Union importers of metals shall carry out audits of their own supply chain due diligence via an independent third-party in accordance with Article 6 of this Regulation. 5. In cases where they are not natural persons, Union importers of metals shall report the findings of the risk assessment referred to in paragraph 4 to their senior management designated for this purpose and they shall implement a response strategy designed to prevent or mitigate adverse impacts, consistent with Annex II to the OECD Due Diligence Guidance and with the specific recommendations set out in that Guidance. Article 6 Third-party audit obligations 1. Union importers of minerals or metals shall carry out audits via an independent third party (\u2018third-party audit\u2019). That third-party audit shall: (a) include in its scope all of the Union importer's activities, processes and systems used to implement supply chain due diligence regarding minerals or metals, including the Union importer's management system, risk management, and disclosure of information in accordance with Articles 4, 5 and 7 respectively; (b) have as its objective the determination of conformity of the Union importer's supply chain due diligence practices with Articles 4, 5 and 7; (c) make recommendations to the Union importer on how to improve its supply chain due diligence practices; and (d) respect the audit principles of independence, competence and accountability, as set out in the OECD Due Diligence Guidance. 2. Union importers of metals shall be exempted from the obligation to carry out third-party audits pursuant to paragraph 1 provided they make available substantive evidence, including third-party audit reports, demonstrating that all smelters and refiners in their supply chain comply with this Regulation. The requirement of substantive evidence shall be deemed to be fulfilled where Union importers of metals demonstrate that they are sourcing exclusively from smelters and refiners listed by the Commission pursuant to Article 9. Article 7 Disclosure obligations 1. Union importers of minerals or metals shall make available to Member State competent authorities the reports of any third-party audit carried out in accordance with Article 6 or evidence of conformity with a supply chain due diligence scheme recognised by the Commission pursuant to Article 8. 2. Union importers of minerals or metals shall make available to their immediate downstream purchasers all information gained and maintained pursuant to their supply chain due diligence with due regard for business confidentiality and other competitive concerns. 3. Union importers of minerals or metals shall, on an annual basis, publicly report as widely as possible, including on the internet, on their supply chain due diligence policies and practices for responsible sourcing. That report shall contain the steps taken by them to implement the obligations as regards their management system under Article 4, and their risk management under Article 5, as well as a summary report of the third-party audits, including the name of the auditor, with due regard for business confidentiality and other competitive concerns. 4. Where a Union importer can reasonably conclude that metals are derived only from recycled or scrap sources, it shall, with due regard for business confidentiality and other competitive concerns: (a) publicly disclose its conclusion; and (b) describe in reasonable detail the supply chain due diligence measures it exercised in reaching that conclusion. Article 8 Recognition of supply chain due diligence schemes 1. Governments, industry associations and groupings of interested organisations having due diligence schemes in place (\u2018scheme owners\u2019) may apply to the Commission to have the supply chain due diligence schemes that are developed and overseen by them recognised by the Commission. Such applications shall be supported by adequate evidence and information. 2. The Commission shall adopt delegated acts in accordance with Article 19, supplementing this Regulation by setting out the methodology and criteria allowing the Commission to assess whether supply chain due diligence schemes facilitate the fulfilment of the requirements of this Regulation by economic operators and allowing the Commission to recognise schemes. 3. Where, on the basis of the evidence and information provided pursuant to paragraph 1 and in accordance with the methodology and criteria for recognition established pursuant to paragraph 2, the Commission determines that the supply chain due diligence scheme, when effectively implemented by a Union importer of minerals or metals, enables that importer to comply with this Regulation, it shall adopt an implementing act granting that scheme a recognition of equivalence with the requirements of this Regulation. The OECD Secretariat shall, as appropriate, be consulted prior to the adoption of such implementing acts. When making a determination on the recognition of a due diligence scheme, the Commission shall take into account the diverse industry practices covered by that scheme and shall also have regard to the risk-based approach and method used by that scheme to identify conflict-affected and high-risk areas, and the listed results thereof. Those listed results shall be disclosed by the scheme owner. The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the advisory procedure referred to in Article 15(2). 4. The Commission shall also, as appropriate, periodically verify that recognised supply chain due diligence schemes continue to fulfil the criteria that led to a recognition of equivalence decision adopted pursuant to paragraph 3. 5. The owner of a supply chain due diligence scheme for which the recognition of equivalence was granted in accordance with paragraph 3 shall inform the Commission without delay of any changes or updates made to that scheme. 6. If there is evidence of repeated or significant cases where economic operators implementing a scheme recognised in accordance with paragraph 3 have failed to fulfil the requirements of this Regulation, the Commission shall examine, in consultation with the owner of the recognised scheme, whether those cases indicate deficiencies in the scheme. 7. Where the Commission identifies a failure to comply with this Regulation or deficiencies in a recognised supply chain due diligence scheme, it may grant the scheme owner an appropriate period of time to take remedial action. Where the scheme owner fails or refuses to take the necessary remedial action, and where the Commission has determined that the failure or deficiencies referred to in the first subparagraph of this paragraph compromise the ability of the Union importer implementing a scheme to comply with this Regulation or where repeated or significant cases of non-compliance by economic operators implementing a scheme are due to deficiencies in the scheme, the Commission shall adopt an implementing act in accordance with the advisory procedure referred to in Article 15(2), withdrawing the recognition of the scheme. 8. The Commission shall establish and keep up-to-date a register of recognised supply chain due diligence schemes. That register shall be made publicly available on the internet. Article 9 List of global responsible smelters and refiners 1. The Commission shall adopt implementing acts establishing or amending the list of the names and addresses of global responsible smelters and refiners. That list shall be drawn up taking into account global responsible smelters and refiners covered by supply chain due diligence schemes recognised by the Commission pursuant to Article 8 and the information submitted by Member States pursuant to Article 17(1). 2. The Commission shall use its best endeavours to identify those smelters and refiners included in the list referred to in paragraph 1 of this Article that source, at least partially, from conflict-affected and high-risk areas, in particular by drawing upon information provided by the owners of supply chain due diligence schemes recognised pursuant to Article 8. 3. The Commission shall establish or amend the list using the template in Annex II and in accordance with the advisory procedure referred to in Article 15(2). The OECD Secretariat shall, as appropriate, be consulted prior to the adoption of that list. 4. The Commission shall, by means of an implementing act, remove from the list the names and addresses of the smelters and refiners that are no longer recognised as responsible on the basis of information received pursuant to Article 8 and Article 17(1). That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 15(2). 5. The Commission shall, in a timely manner, update and make publicly available, including on the internet, the information included in the list of global responsible smelters and refiners. Article 10 Member State competent authorities 1. Each Member State shall designate one or more competent authorities responsible for the application of this Regulation. Member States shall inform the Commission of the names and addresses of the competent authorities by 9 December 2017. Member States shall inform the Commission of any changes to the names or addresses of the competent authorities. 2. The Commission shall make publicly available, including on the internet, a list of competent authorities using the template in Annex III. The Commission shall keep that list up-to-date. 3. Member State competent authorities shall be responsible for ensuring the effective and uniform implementation of this Regulation throughout the Union. Article 11 Ex-post checks on Union importers 1. Member State competent authorities shall be responsible for carrying out appropriate ex-post checks in order to ensure that Union importers of minerals or metals comply with the obligations set out in Articles 4 to 7. 2. The ex-post checks referred to in paragraph 1 shall be conducted by taking a risk-based approach, as well as in cases when a competent authority is in possession of relevant information, including on the basis of substantiated concerns provided by third parties, concerning the compliance by a Union importer with this Regulation. 3. The ex-post checks referred to in paragraph 1 shall include, inter alia: (a) examination of the Union importer's implementation of supply chain due diligence obligations under this Regulation, including regarding the management system, risk management, independent third-party audit and disclosure; (b) examination of documentation and records that demonstrate the proper compliance with the obligations referred to in point (a); (c) examination of audit obligations in accordance with the scope, objective and principles set out in Article 6. The ex-post checks referred to in paragraph 1 should include on-the-spot inspections, including at the premises of the Union importer. 4. Union importers shall offer all the assistance necessary to facilitate the performance of the ex-post checks referred to in paragraph 1, in particular as regards access to premises and the presentation of documentation and records. 5. In order to ensure clarity of tasks and consistency of action among Member State competent authorities, the Commission shall prepare non-binding guidelines in the form of a handbook detailing the steps to be followed by Member State competent authorities carrying out the ex-post checks referred to in paragraph 1. Those guidelines shall include, as appropriate, templates of documents facilitating the implementation of this Regulation. Article 12 Records of ex-post checks on Union importers Member State competent authorities shall keep records of the ex-post checks referred to in Article 11(1), indicating in particular the nature and results of such checks, as well as records of any notice of remedial action issued under Article 16(3). Records of the ex-post checks referred to in Article 11(1) shall be kept for at least five years. Article 13 Cooperation and information exchange 1. Member State competent authorities shall exchange information, including with their respective customs authorities, on matters pertaining to supply chain due diligence and ex-post checks carried out. 2. Member State competent authorities shall exchange information on shortcomings detected through the ex-post checks referred to in Article 11(1) and on the rules applicable to infringement in accordance with Article 16 with the competent authorities of other Member States and with the Commission. 3. Cooperation under paragraphs 1 and 2 shall fully respect Directive 95/46/EC of the European Parliament and of the Council (9) and Regulation (EC) No 45/2001 of the European Parliament and of the Council (10) as regards data protection and Regulation (EU) No 952/2013 as regards the disclosure of confidential information. Article 14 Guidelines 1. In order to create clarity and certainty for and consistency among the practices of economic operators, in particular SMEs, the Commission, in consultation with the European External Action Service and the OECD, shall prepare non-binding guidelines in the form of a handbook for economic operators, explaining how best to apply the criteria for the identification of conflict-affected and high-risk areas. That handbook shall be based on the definition of conflict-affected and high-risk areas set out in Article 2(f) of this Regulation and shall take into account the OECD Due Diligence Guidance in this field, including other supply chain risks triggering red flags as defined in the relevant supplements to that Guidance. 2. The Commission shall call upon external expertise that will provide an indicative, non-exhaustive, regularly updated list of conflict-affected and high-risk areas. That list shall be based on the external experts' analysis of the handbook referred to in paragraph 1 and existing information from, inter alia, academics and supply chain due diligence schemes. Union importers sourcing from areas which are not mentioned on that list shall also maintain their responsibility to comply with the due diligence obligations under this Regulation. Article 15 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so request. Article 16 Rules applicable to infringement 1. Member States shall lay down the rules applicable to infringements of this Regulation. 2. Member States shall notify the rules referred to in paragraph 1 to the Commission and shall notify it without delay of any subsequent amendment thereto. 3. In the case of an infringement of this Regulation, Member State competent authorities shall issue a notice of remedial action to be taken by the Union importer. Article 17 Reporting and review 1. By 30 June each year, Member States shall submit to the Commission a report on the implementation of this Regulation and, in particular, on notices of remedial action issued by their competent authorities pursuant to Article 16(3) and on the third-party audit reports made available pursuant to Article 7(1). 2. By 1 January 2023 and every three years thereafter, the Commission shall review the functioning and effectiveness of this Regulation. That review shall take into account the impact of this Regulation on the ground, including on the promotion and cost of responsible sourcing of the minerals within its scope from conflict-affected and high-risk areas and the impact of this Regulation on Union economic operators, including SMEs, as well as the accompanying measures outlined in the Joint Communication of 5 March 2014. The Commission shall discuss the review report with the European Parliament and with the Council. The review shall include an independent assessment of the proportion of total downstream Union economic operators with tin, tantalum, tungsten or gold in their supply chain, which have due diligence schemes in place. The review shall assess the adequacy and implementation of these due diligence schemes and the impact of the Union system on the ground as well as the need for additional mandatory measures in order to ensure sufficient leverage of the total Union market on the responsible global supply chain of minerals. 3. Based on the findings of the review under paragraph 2, the Commission shall assess whether Member State competent authorities should have competence to impose penalties upon Union importers in the event of persistent failure to comply with the obligations set out in this Regulation. It may, as appropriate, submit a legislative proposal to the European Parliament and to the Council in this regard. Article 18 Methodology for calculation of thresholds Unless otherwise provided in this Regulation, on the basis of customs information that shall be provided upon request of the Commission by the Member States on the annual import volumes by Union importer and by Combined Nomenclature code as listed in Annex I in their respective territories, the Commission shall select the highest annual import volume per Union importer and per Combined Nomenclature code corresponding to no less than 95 % of the total annual volume of imports into the Union for that Combined Nomenclature code as the new threshold to be inserted in Annex I. The Commission shall rely in doing so on the import information for each Union importer provided by the Member States for the previous two years. Article 19 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 1(4) and (5) and Article 8(2) shall be conferred on the Commission for a period of five years from 8 June 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power referred to in Article 1(5) and Article 8(2) shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 1(4) and (5) and Article 8(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 1(4) and (5) and Article 8(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 20 Entry into force and date of application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. With the exception of the provisions referred to in paragraph 3, this Regulation shall apply from 9 July 2017. 3. Article 1(5), Article 3(1) and (2), Articles 4 to 7, Article 8(6) and (7), Article 10(3), Article 11(1), (2), (3), and (4), Articles 12 and 13, Article 16(3), and Article 17 shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 17 May 2017. For the European Parliament The President A. TAJANI For the Council The President C. ABELA (1) Position of the European Parliament of 16 March 2017 (not yet published in the Official Journal) and decision of the Council of 3 April 2017. (2) OECD Guidelines for Multinational Enterprises, OECD 2011 edition. (3) Guiding Principles on Business and Human Rights: Implementing the United Nations \u2018Protect, Respect and Remedy\u2019 Framework, endorsed by the UN Human Rights Council in its resolution 17/4 of 6 July 2011 (A/HRC/RES/17/4). (4) Regulation (EU) No 1287/2013 of the European Parliament and of the Council of 11 December 2013 establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (COSME) (2014-2020) and repealing Decision No 1639/2006/EC (OJ L 347, 20.12.2013, p. 33). (5) OJ L 123, 12.5.2016, p. 1. (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (8) Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015 supplementing Regulation (EU) No 952/2013 of the European Parliament and of the Council as regards detailed rules concerning certain provisions of the Union Customs Code (OJ L 343, 29.12.2015, p. 1). (9) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (10) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). ANNEX I List of minerals and metals within the scope of Regulation (EU) 2017/821 classified under the Combined Nomenclature Part A: Minerals Description CN code TARIC subdivision Volume threshold (kg) Tin ores and concentrates 2609 00 00 5 000 Tungsten ores and concentrates 2611 00 00 250 000 Tantalum or niobium ores and concentrates ex 2615 90 00 10 Article 1(4) and Article 18 apply Gold ores and concentrates ex 2616 90 00 10 Article 1(4) and Article 18 apply Gold, unwrought or in semi-manufactured forms, or in powder with a gold concentration lower than 99,5 % that has not passed the refining stage ex 7108 (*1) 100 Part B: Metals Description CN code TARIC subdivision Volume threshold (kg) Tungsten oxides and hydroxides 2825 90 40 100 000 Tin oxides and hydroxides ex 2825 90 85 10 Article 1(4) and Article 18 apply Tin chlorides 2827 39 10 10 000 Tungstates 2841 80 00 100 000 Tantalates ex 2841 90 85 30 Article 1(4) and Article 18 apply Carbides of tungsten 2849 90 30 10 000 Carbides of tantalum ex 2849 90 50 10 Article 1(4) and Article 18 apply Gold, unwrought or in semi-manufactured forms, or in powder form with a gold concentration of 99,5 % or higher that has passed the refining stage ex 7108 (*2) 100 Ferrotungsten and ferro-silico-tungsten 7202 80 00 25 000 Tin, unwrought 8001 100 000 Tin bars, rods, profiles and wires 8003 00 00 1 400 Tin, other articles 8007 00 2 100 Tungsten, powders 8101 10 00 2 500 Tungsten, unwrought, including bars and rods obtained simply by sintering 8101 94 00 500 Tungsten wire 8101 96 00 250 Tungsten bars and rods, other than those obtained simply by sintering, profiles, plates, sheets, strip and foil, and other 8101 99 350 Tantalum, unwrought including bars and rods, obtained simply by sintering; powders 8103 20 00 2 500 Tantalum bars and rods, other than those obtained simply by sintering, profiles, wire, plates, sheets, strip and foil, and other 8103 90 150 (*1) For the purpose of amending this threshold, the imported volume obtained by applying the methodology and criteria of Article 18 shall be set as the threshold for both ex 7108 tariff lines included in Annex I. (*2) For the purpose of amending this threshold, the imported volume obtained by applying the methodology and criteria of Article 18 shall be set as the threshold for both ex 7108 tariff lines included in Annex I. ANNEX II List of global responsible smelters and refiners' template referred to in Article 9 Column A: Name of smelters and refiners in alphabetical order Column B: Address of the smelter or refiner Column C: * indicator, if the smelter or refiner sources minerals originating from conflict-affected and high-risk areas A B C ANNEX III List of Member State competent authorities template referred to in Article 10 Column A: Name of Member States in alphabetical order Column B: Name of the competent authority Column C: Address of the competent authority A B C", "summary": "Responsible trade in minerals from high-risk or conflict areas Responsible trade in minerals from high-risk or conflict areas SUMMARY OF: Regulation (EU) 2017/821 on the obligations of importers of tin, tantalum and tungsten, their ores, and gold from conflict-affected and high-risk areas WHAT IS THE AIM OF THE REGULATION? The European Union (EU) regulation aims to: ensure that EU importers of tin, tungsten, tantalum and gold (3TG) meet international responsible sourcing standards set by the Organisation for Economic Co-operation and Development (OECD); ensure that global and EU smelters and refiners* source 3TG responsibly; help break the link between conflict and the illegal exploitation of minerals; help put an end to the exploitation and abuse of local communities, including mine workers, and support local development. KEY POINTS In politically unstable areas, trade in minerals such as 3TG can be used to finance armed groups, lead to forced labour and other human rights abuses, and support corruption and money laundering. These conflict minerals are then used in everyday products, such as mobile phones, cars or jewellery. Due diligence The term due diligence means to act with reasonable care and investigate an issue before making a decision. It is an ongoing, proactive and reactive process by which companies put in place systems and processes to identify, manage and report on risks in their supply chains. For the minerals covered by the regulation, it means that companies must check that what they buy is sourced responsibly and does not contribute to conflict or other related illegal activities. Companies that practise due diligence initially check how risky it is to source raw materials from a fragile or conflict-affected area. They assess the likelihood that these raw materials could be financing conflict, forced labour or other risks set out in the regulation. By checking their supply chains, they can make sure that they manage these risks responsibly. The regulation builds on the 2011 OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas, which sets the international benchmark for supply chain due diligence, and the 2014 joint communication \u2018Responsible sourcing of minerals originating in conflict-affected and high-risk areas: Towards an integrated EU approach\u2019. Under the regulation, EU mineral importers must: identify and assess the risks in their mineral supply chain; implement a strategy to respond to these risks; carry out an independent third-party audit of supply chain due diligence; report annually on their policies and practices for responsible sourcing. The competent authorities of the EU Member States must carry out checks to ensure that EU mineral and metal importers comply with their due diligence obligations. Supply chain due diligence schemes Governments, industry associations and groups of interested organisations with due diligence schemes in place may apply to have their schemes recognised by the European Commission as complying with the regulation. A delegated act, Delegated Regulation (EU) 2019/429 sets out the methodology and criteria allowing the Commission to assess whether supply chain due diligence schemes concerning 3TG meet the requirements of Regulation (EU) 2017/821, and to recognise such schemes. The Commission will establish a register of recognised supply chain due diligence schemes, publicly available on the internet, and a list of global responsible smelters and refiners. Guidelines In consultation with the European External Action Service and the OECD, the Commission has prepared non-binding guidelines for economic operators that explain how best to apply the criteria for the identification of conflict-affected and high-risk areas. Recommendation (EU) 2018/1149 provides in its Annex non-binding guidelines for the identification of conflict-affected and high-risk areas and other supply chain risks under Regulation (EU) 2017/821 of the European Parliament and of the Council. Review By 1 January 2023 and every 3 years thereafter, the Commission will review the operation, effectiveness and impact of the new system, and will propose new measures in order to ensure a continuing responsible global supply chain for minerals. Amendment to Regulation (EU) 2017/821 Delegated Regulation (EU) 2020/1588 amends Annex I to Regulation (EU) 2017/821 by setting volume thresholds for tantalum or niobium ores and concentrates, gold ores and concentrates, tin oxides and hydroxides, and tantalates and carbides of tantalum. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND For more information, see: Conflict minerals \u2014 the regulation explained (European Commission) OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (OECD). KEY TERMS Smelters and refiners. Individuals or businesses performing forms of extractive metallurgy involving processing steps with the aim of producing a metal from a mineral. MAIN DOCUMENT Regulation (EU) 2017/821 of the European Parliament and of the Council of 17 May 2017 laying down supply chain due diligence obligations for Union importers of tin, tantalum and tungsten, their ores, and gold originating from conflict-affected and high-risk areas (OJ L 130, 19.5.2017, pp. 1\u201320). Successive amendments to Regulation (EU) 2017/821 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2019/429 of 11 January 2019 supplementing Regulation (EU) 2017/821 of the European Parliament and of the Council as regards the methodology and criteria for the assessment and recognition of supply chain due diligence schemes concerning tin, tantalum, tungsten and gold (OJ L 75, 19.3.2019, pp. 59\u201365). Commission Recommendation (EU) 2018/1149 of 10 August 2018 on non-binding guidelines for the identification of conflict-affected and high-risk areas and other supply chain risks under Regulation (EU) 2017/821 of the European Parliament and of the Council (OJ L 208, 17.8.2018, pp. 94\u2013106). Joint communication to the European Parliament and the Council \u2014 Responsible sourcing of minerals originating in conflict-affected and high-risk areas: Towards an integrated EU approach (JOIN(2014) 8 final, 5.3.2014). Commission staff working document assessment Part I (Impact Assessment) Accompanying the document Proposal for a Regulation of the European Parliament and of the Council setting up a Union system for supply chain due diligence self-certification of responsible importers of tin, tantalum and tungsten, their ores, and gold originating in conflict-affected and high-risk areas (SWD(2014) 53 final, 5.3.2014). Communication from the Commission to the European Parliament and the Council \u2014 The raw materials initiative: meeting our critical needs for growth and jobs in Europe (COM(2008) 699 final, 4.11.2008). last update 19.10.2021"}
{"article": "10.10.2013 EN Official Journal of the European Union L 269/1 REGULATION (EU) No 952/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 October 2013 laying down the Union Customs Code (recast) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33, 114 and 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) A number of amendments are to be made to Regulation (EC) No 450/2008 of the European Parliament and of the Council of 23 April 2008 laying down the Community Customs Code (Modernised Customs Code) (3). In the interests of clarity, that Regulation should be recast. (2) It is appropriate to ensure that Regulation (EC) No 450/2008 is consistent with the Treaty on the Functioning of the European Union (TFEU), in particular Articles 290 and 291 thereof. It is also appropriate that the Regulation take account of the evolution of Union law and that some of its provisions are adapted in order to facilitate their application. (3) In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (4) In particular, when preparing and drawing up delegated acts, the Commission should ensure that Member States' experts and the business community are consulted in a transparent manner, and well in advance. (5) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in order: to specify the format and code of the common data requirements for the purpose of the exchange of information between the customs authorities and between economic operators and customs authorities and the storage of such information and the procedural rules on the exchange and storage of information which can be made by means other than electronic data-processing techniques; to adopt decisions allowing one or several Member States to use means for the exchange and storage of information other than electronic data-processing techniques; to specify the customs authority which is responsible for the registration of economic operators and of other persons; to specify the technical arrangements for developing, maintaining and employing electronic systems; to specify the procedural rules on the conferral and proving of the entitlement for a customs representative to provide services in a Member State other than the one where he or she is established; the procedural rules on the submission and acceptance of an application for a decision relating to the application of the customs legislation, and on the taking and the monitoring of such a decision; the procedural rules on the annulment, revocation and amendment of favourable decisions; the procedural rules on the use of a decision relating to binding information after it ceases to be valid or is revoked; the procedural rules on the notification to the customs authorities that the taking of such decisions is suspended and on the withdrawal of such suspension; to adopt decisions requesting Member States to revoke decisions relating to binding information; to adopt the modalities for the application of the criteria for the granting of the status of authorised economic operator; to adopt measures to ensure uniform application of customs controls, including the exchange of risk information and analysis, common risk criteria and standards, control measures and priority control areas; to determine the ports or airports where customs controls and formalities are to be carried out on cabin and hold baggage; to lay down the rules on currency conversion; to adopt measures on the uniform management of tariff quota and tariff ceilings and the management of the surveillance of the release for free circulation or export of goods; to adopt measures to determine the tariff classification of goods; to specify the procedural rules on the provision and the verification of the proof of non-preferential origin; the procedural rules on the facilitation of the establishment in the Union of the preferential origin of goods; to adopt measures to determine the origin of specific goods; the granting of a temporary derogation from the rules on preferential origin of goods benefiting from preferential measures adopted unilaterally by the Union; the determination of the origin of specific goods; to specify the procedural rules on the determination of the customs value of goods; to specify the procedural rules on the provision of a guarantee, the determination of its amount, its monitoring and release and the revocation and cancellation of an undertaking given by a guarantor; to specify the procedural rules regarding temporary prohibitions of the use of comprehensive guarantees; to adopt measures to ensure mutual assistance between the customs authorities in the event of the incurrence of a customs debt; to specify the procedural rules on repayment and remission of an amount of import or export duty and the information to be provided to the Commission; to adopt decisions on repayment or remission of an amount of import or export duty; to specify the procedural rules on the lodging, amendment and invalidation of an entry summary declaration; to specify the time-limit within which a risk analysis is to be carried out on the basis of the entry summary declaration; to specify the procedural rules on the notification of arrival of sea-going vessels and aircraft and on the conveyance of goods to the appropriate place; to specify the procedural rules on the presentation of goods to customs; the procedural rules on the lodging, amendment and invalidation of the temporary storage declaration and on the movement of goods in temporary storage; the procedural rules for the provision and verification of the proof of the customs status of Union goods; the procedural rules on the determination of competent customs offices and on the lodging of the customs declaration where other means than electronic data processing techniques are used; the procedural rules on the lodging of a standard customs declaration and on the making available of supporting documents; the procedural rules on the lodging of a simplified declaration and a supplementary declaration; the procedural rules on the lodging of a customs declaration prior to the presentation of goods to customs, the acceptance of the customs declaration and the amendment of the customs declaration after the release of the goods; to adopt measures for the determination of the tariff subheading of the goods which are subject to the highest rate of import or export duty where a consignment is made of goods falling under different tariff subheadings; to specify the procedural rules on centralised clearance and on the waiver from the obligation for goods to be presented in that context; the procedural rules on entry in the declarant's records; the procedural rules on the customs formalities and controls to be carried out by the holder of the authorisation in the context of self-assessment; to adopt measures on the verification of the customs declaration, the examination and sampling of goods and the results of the verification; the procedural rules on the disposal of goods; the procedural rules on the provision of information establishing that the conditions for relief from import duty for returned goods are fulfilled and on the provision of evidence that the conditions for relief from import duty for products of sea-fishing and other products taken from the sea are fulfilled; the procedural rules on the examination of the economic conditions in the context of special procedures; the procedural rules on the discharge of a special procedure; the procedural rules on the transfer of rights and obligations and the movement of goods in the context of special procedures; the procedural rules on the use of equivalent goods in the context of special procedures; the procedural rules for the application of the provisions of international transit instruments in the customs territory of the Union; the procedural rules on the placing of goods under the Union transit procedure and on the end of that procedure, on the operation of the simplifications of that procedure and on the customs supervision of goods passing through the territory of a country or territory outside the customs territory of the Union under the external Union transit procedure; the procedural rules on the placing of goods under the customs warehousing or free zone procedure; to lay down the time-limit within which risk analysis is to be carried out on the basis of the pre-departure declaration; to specify the procedural rules on the exit of goods; the procedural rules on the lodging, amendment and invalidation of the exit summary declaration; the procedural rules on the lodging, amendment and invalidation of the re-export notification; to adopt a work programme supporting the development of related electronic systems and governing the setting up of transitional periods; to adopt decisions authorising Member States to test simplifications in the application of the customs legislation, especially when those simplifications are information technology (IT) related. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (4). (6) Considering the cooperation which is needed between the Member States and the Commission to develop, maintain and employ the electronic systems required for the implementation of the Union Customs Code (the Code), the Commission should not adopt the work programme supporting that development and governing the setting up of transitional periods where no opinion is delivered by the committee examining the draft implementing act. (7) The advisory procedure should be used for the adoption of: decisions allowing one or several Member States to use means for the exchange and storage of information other than electronic data-processing techniques, given that those decisions do not affect all Member States; decisions requesting Member States to revoke decisions relating to binding information, given that those decisions affect only one Member State and aim at ensuring compliance with the customs legislation; decisions on repayment or remission of an amount of import or export duty given that those decisions directly affect the applicant for that repayment or remission. (8) In duly justified cases, where imperative grounds of urgency so require, the Commission should adopt immediately applicable implementing acts relating to: measures to ensure uniform application of customs controls, including the exchange of risk information and analysis, common risk criteria and standards, control measures and priority control areas; the determination of the tariff classification of goods; the determination of the origin of specific goods; measures temporarily prohibiting the use of comprehensive guarantees. (9) The Union is based upon a customs union. It is advisable, in the interests both of economic operators and of the customs authorities in the Union, to assemble current customs legislation in a code. Based on the concept of an internal market, that code should contain the general rules and procedures which ensure the implementation of the tariff and other common policy measures introduced at Union level in connection with trade in goods between the Union and countries or territories outside the customs territory of the Union, taking into account the requirements of those common policies. Customs legislation should be better aligned on the provisions relating to the collection of import charges without change to the scope of the tax provisions in force. (10) In order to ensure effective administrative simplification, the views of economic operators should be taken into account when the customs legislation is further modernised. (11) In accordance with the Commission Communication of 9 August 2004 entitled \"Protecting the Communities' financial interests - Fight against fraud - Action Plan for 2004-2005\", it is appropriate to adapt the legal framework for the protection of the financial interests of the Union. (12) Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (5) was based upon integration of the customs procedures applied separately in the respective Member States during the 1980s. That Regulation has been repeatedly and substantially amended since its introduction, in order to address specific problems such as the protection of good faith or the taking into account of security requirements. Further amendments to that Regulation were introduced by Regulation (EC) No 648/2005 of the European Parliament and of the Council of 13 April 2005 (6) - and subsequently included in Regulation (EC) No 450/2008 - as a consequence of the important legal changes which have occurred in recent years, at both Union and international level, such as the expiry of the Treaty establishing the European Coal and Steel Community and the entry into force of the 2003, 2005 and 2011 Acts of Accession, as well as the amendment to the International Convention on the simplification and harmonisation of customs procedures (the Revised Kyoto Convention), the Union's accession to which was approved by Council Decision 2003/231/EC of 17 March 2003 (7). (13) It is appropriate to introduce in the Code a legal framework for the application of certain provisions of the customs legislation to trade in Union goods between parts of the customs territory to which the provisions of Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (8) or Council Directive 2008/118/EC of 16 December 2008 concerning the general arrangements for excise duty (9) apply and parts of that territory where those provisions do not apply, or to trade between parts where those provisions do not apply. Considering the fact that the goods concerned are Union goods and considering the fiscal nature of the measures at stake in that intra-Union trade, it is justified to introduce, appropriate simplifications to the customs formalities to be applied to those goods. (14) In order to take into account the special fiscal regime of certain parts of the customs territory of the Union, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the customs formalities and controls to be applied to the trade in Union goods between those parts and the rest of the customs territory of the Union. (15) The facilitation of legitimate trade and the fight against fraud require simple, rapid and standard customs procedures and processes. It is therefore appropriate, in line with the Commission Communication of 24 July 2003 entitled \"A simple and paperless environment for customs and trade\", to simplify customs legislation, to allow the use of modern tools and technology and to promote further the uniform application of customs legislation and modernised approaches to customs control, thus helping to ensure the basis for efficient and simple clearance procedures. Customs procedures should be merged or aligned and the number of procedures reduced to those that are economically justified, with a view to increasing the competitiveness of business. (16) The completion of the internal market, the reduction of barriers to international trade and investment and the reinforced need to ensure security and safety at the external borders of the Union have transformed the role of customs authorities giving them a leading role within the supply chain and, in their monitoring and management of international trade, making them a catalyst to the competitiveness of countries and companies. The customs legislation should therefore reflect the new economic reality and the new role and mission of customs authorities. (17) The use of information and communication technologies, as laid down in Decision No 70/2008/EC of the European Parliament and of the Council of 15 January 2008 on a paperless environment for customs and trade (10), is a key element in ensuring trade facilitation and, at the same time, the effectiveness of customs controls, thus reducing costs for business and risk for society. It is therefore necessary to establish in the Code the legal framework within which that Decision can be implemented, in particular the legal principle that all customs and trade transactions are to be handled electronically and that information and communication systems for customs operations are to offer, in each Member State, the same facilities to economic operators. (18) In order to ensure a paperless environment for customs and trade, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of common data requirements for the purpose of the exchange and storage of information using electronic data processing techniques, cases where other means may be used for such exchange and storage and registration of persons. Means other than electronic data processing techniques could be used in particular on a transitional basis, where the necessary electronic systems are not yet operational, but not beyond 31 December 2020. Insofar as centralised clearance is concerned, those transitional measures would consist, until the necessary electronic systems are operational, in maintaining the procedure currently known as the 'single authorisation for simplified procedures'. (19) Use of information and communication technologies should be accompanied by harmonised and standardised application of customs controls by the Member States, to ensure an equivalent level of customs control throughout the Union so as not to give rise to anti-competitive behaviour at the various Union entry and exit points. (20) In the interests of facilitating business, while at the same time providing for the proper levels of control of goods brought into or taken out of the customs territory of the Union, it is desirable that the information provided by economic operators be shared, taking account of the relevant data-protection provisions, between customs authorities and with other agencies involved in that control. Those controls should be harmonised, so that the economic operator need give the information only once and that goods are controlled by those authorities at the same time and at the same place. (21) In the interests of facilitating business, all persons should continue to have the right to appoint a representative in their dealings with the customs authorities. However, it should no longer be possible for that right of representation to be reserved under a law laid down by one of the Member States. Furthermore, a customs representative who complies with the criteria for the granting of the status of authorised economic operator for customs simplifications should be entitled to provide his or her services in a Member State other than the Member State where he or she is established. As a general rule, a customs representative should be established in the customs territory of the Union. That obligation should be waived where the customs representative acts on behalf of persons who are not required to be established within the customs territory of the Union or in other justified cases. (22) All decisions relating to the application of the customs legislation, including to binding information, should be covered by the same rules. Any such decisions should be valid throughout the Union and should be capable of being annulled, amended except where otherwise stipulated, or revoked where they do not conform to the customs legislation or its interpretation. (23) The streamlining of customs procedures within an electronic environment requires the sharing of responsibilities between the customs authorities of different Member States. It is necessary to ensure an appropriate level of effective, dissuasive and proportionate penalties throughout the internal market. (24) Compliant and trustworthy economic operators should enjoy the status of 'authorised economic operator' subject to the granting of an authorisation for customs simplifications or an authorisation for security and safety, or both. Depending on the type of authorisation granted, authorised economic operators should be able to take maximum advantage of widespread use of customs simplifications or benefit from facilitations relating to security and safety. They should also be given more favourable treatment in respect of customs controls, such as fewer physical and document-based controls. (25) Compliant and trustworthy economic operators should benefit from international mutual recognition of the status of 'authorised economic operator'. (26) In order to secure a balance between, on the one hand, the need for customs authorities to ensure the correct application of the customs legislation and, on the other, the right of economic operators to be treated fairly, the customs authorities should be granted extensive powers of control and economic operators a right of appeal. (27) In accordance with the Charter of Fundamental Rights of the European Union, it is necessary, in addition to the right of appeal against any decision taken by the customs authorities, to provide for the right of every person to be heard before any decision is taken which would adversely affect him or her. However, restrictions to that right may be justified in particular where the nature or the level of the threat to the security and safety of the Union and its residents, to human, animal or plant health, to the environment or to consumers so requires. (28) In order to minimise the risk to the Union, its citizens and its trading partners, the harmonised application of customs controls by the Member States should be based upon a common risk management framework and an electronic system for its implementation. The establishment of a risk management framework common to all Member States should not prevent them from controlling goods by random checks. (29) In order to ensure a consistent and equal treatment of persons concerned by customs formalities and controls, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of determining other cases where the customs representative is not obliged to be established in the customs territory of the Union and rules relating to decisions taken by the customs authorities, including those relating to binding information, authorised economic operator and simplifications. (30) It is necessary to establish the factors on the basis of which import or export duty and other measures in respect of trade in goods are applied. It is also appropriate to lay down more detailed provisions for issuing proofs of origin in the Union, where the exigencies of trade so require. (31) In order to supplement the factors on the basis of which import or export duty and other measures are applied, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules on origin of goods. (32) It is desirable to group together all cases of incurrence of a customs debt on import, other than following the submission of a customs declaration for release for free circulation or temporary admission with partial relief, in order to avoid difficulties in determining the legal basis on which the customs debt was incurred. The same should apply in cases of incurrence of a customs debt on export. (33) It is appropriate to establish the place where the customs debt is incurred and where the import or export duty should be recovered. (34) The rules for special procedures should allow for the use of a single guarantee for all categories of special procedures and for that guarantee to be comprehensive, covering a number of transactions. (35) A comprehensive guarantee with a reduced amount, including for customs debts and other charges which have been incurred, or a comprehensive guarantee with a guarantee waiver, should be authorised under certain conditions. A comprehensive guarantee with a reduced amount for customs debts and other charges which have been incurred should be equivalent to the provision of a guarantee for the whole amount of import or export duty payable, in particular for the purposes of the release of the goods concerned and of the entry in the accounts. (36) In order to ensure better protection of the financial interests of the Union and of the Member States, a guarantee should cover non-declared or incorrectly declared goods included in a consignment or in a declaration for which it is provided. For the same reason, the undertaking of the guarantor should also cover amounts of import or export duty which fall to be paid following post-release controls. (37) In order to safeguard the financial interests of the Union and of the Member States and to curb fraudulent practices, arrangements involving graduated measures for the application of a comprehensive guarantee are advisable. Where there is an increased risk of fraud it should be possible to prohibit temporarily the application of the comprehensive guarantee, taking account of the particular situation of the economic operators concerned. (38) It is appropriate to take account of the good faith of the person concerned in cases where a customs debt is incurred through non-compliance with the customs legislation and to minimise the impact of negligence on the part of the debtor. (39) In order to protect the financial interests of the Union and of the Member States and to supplement the rules concerning the customs debt and the guarantees, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the place of incurrence of the customs debt, the calculation of the amount of import and export duty, the guarantee of that amount and the recovery, repayment, remission and extinguishment of the customs debt. (40) It is necessary to lay down the principle of how to determine the customs status of Union goods and the circumstances pertaining to the loss of such status, and to provide a basis for determining when that status remains unaltered in cases where goods are temporarily taken out of the customs territory of the Union. (41) In order to ensure free movement of Union goods in the customs territory of the Union and customs treatment of non-Union goods brought into that territory, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the determination of the customs status of goods, the loss of the customs status of Union goods, the preservation of that status for goods temporarily leaving the customs territory of the Union and the duty relief for returned goods. (42) It is appropriate, where an economic operator has provided, in advance, the information necessary for risk-based controls on the admissibility of the goods, to ensure that quick release of goods is then the rule. Fiscal and trade policy controls should primarily be performed by the customs office competent in respect of the premises of the economic operator. (43) The rules for customs declarations and for the placing of goods under a customs procedure should be modernised and streamlined, in particular by requiring that, as a rule, customs declarations be made electronically and by providing for only one type of simplified declaration and for the possibility to lodge a customs declaration in the form of an entry in the declarant's records. (44) Since the Revised Kyoto Convention favours the lodging, registering and checking of the customs declaration prior to the arrival of the goods and, furthermore, the dissociation of the place where the declaration is lodged from the place where the goods are physically located, it is appropriate to provide for centralised clearance at the place where the economic operator is established. (45) It is appropriate to lay down at Union level the rules governing the destruction or disposal otherwise of goods by the customs authorities, since these are matters which previously required national legislation. (46) In order to supplement the rules regarding the placing of goods under a customs procedure and ensure equal treatment of the persons concerned, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the rules relating to the customs declaration and the release of goods. (47) It is appropriate to lay down common and simple rules for the special procedures, supplemented by a small set of rules for each category of special procedure, in order to make it simple for the operator to choose the right procedure, to avoid errors and to reduce the number of post-release recoveries and repayments. (48) The granting of authorisations for several special procedures with a single guarantee and a single supervising customs office should be facilitated and there should be simple rules on the incurrence of a customs debt in these cases. The basic principle should be that goods placed under a special procedure, or the products made from them, are to be assessed at the time when the customs debt is incurred. However, it should also be possible, where economically justified, to assess the goods at the time when they were placed under a special procedure. The same principles should apply to usual forms of handling. (49) In view of increased security-related measures, the placing of goods into free zones should become a customs procedure and the goods should be subject to customs controls at entry and with regard to records. (50) Given that the intention of re-export is no longer necessary, the inward processing suspension procedure should be merged with processing under customs control and the inward processing drawback procedure abandoned. This single inward processing procedure should also cover destruction, except where destruction is carried out by, or under the supervision of, customs. (51) In order to supplement the rules on special procedures and ensure equal treatment of the persons concerned, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the rules relating to cases where goods are placed under special procedures, movements, usual forms of handling and equivalence of those goods and discharge of those procedures. (52) Security-related measures relating to Union goods taken out of the customs territory of the Union should apply equally to the re-export of non-Union goods. The same rules should apply to all types of goods, with the possibility of exceptions where necessary, such as for goods only transiting through the customs territory of the Union. (53) In order to ensure the customs supervision of goods brought into and taken out of the customs territory of the Union and the application of security-related measures, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the rules relating to entry summary declaration and pre-departure declarations. (54) In order to explore further customs and trade facilitation, in particular by making use of the most recent tools and technology, Member States should be authorised, under certain conditions and upon application, to test for a limited period of time simplifications in the application of the customs legislation. That possibility should not jeopardise the application of the customs legislation or create new obligations for economic operators, who may take part in these tests on a purely voluntary basis. (55) In accordance with the principle of proportionality, as set out in Article 5 of the Treaty on European Union (TEU), it is necessary and appropriate, for the achievement of the basic objectives of enabling the customs union to function effectively and implementing the common commercial policy, to lay down the general rules and procedures applicable to goods brought into or taken out of the customs territory of the Union. In accordance with the first subparagraph of Article 5(4) TEU, this Regulation does not go beyond what is necessary in order to achieve those objectives. (56) In order to simplify and rationalise customs legislation, a number of provisions contained in autonomous Union acts have, for the sake of transparency, been incorporated into the Code. Council Regulation (EEC) No 3925/91 of 19 December 1991 concerning the elimination of controls and formalities applicable to the cabin and hold baggage of persons taking an intra-Community flight and the baggage of persons making an intra-Community sea crossing (11), Regulation (EEC) No 2913/92, Council Regulation (EC) No 1207/2001 of 11 June 2001 on procedures to facilitate the issue or the making out in the Community of proofs of origin and the issue of certain approved exporter authorisations under the provisions governing preferential trade between the European Community and certain countries (12), and Regulation (EC) No 450/2008 should therefore be repealed. (57) The provisions of this Regulation setting out the delegation of power and the conferral of implementing powers and the provisions on charges and costs should apply from the date of entry into force of this Regulation. The other provisions should apply from 1 June 2016. (58) This Regulation should be without prejudice to existing and future Union rules on access to documents adopted in accordance with Article 15(3) TFEU. It should also be without prejudice to national rules on access to documents. (59) The Commission should make every effort to ensure that the delegated and implementing acts provided for in this Regulation enter into force sufficiently in advance of the application date of the Code to allow its timely implementation by Member States, HAVE ADOPTED THIS REGULATION: TABLE OF CONTENTS TITLE I GENERAL PROVISIONS 11 CHAPTER 1 Scope of the customs legislation, mission of customs and definitions 11 CHAPTER 2 Rights and obligations of persons with regard to the customs legislation 15 Section 1 Provision of information 15 Section 2 Customs representation 18 Section 3 Decisions relating to the application of the customs legislation 19 Section 4 Authorised economic operator 24 Section 5 Penalties 25 Section 6 Appeals 26 Section 7 Control of goods 26 Section 8 Keeping of documents and other information, and charges and costs 28 CHAPTER 3 Currency conversion and time-limits 29 TITLE II FACTORS ON THE BASIS OF WHICH IMPORT OR EXPORT DUTY AND OTHER MEASURES IN RESPECT OF TRADE IN GOODS ARE APPLIED 29 CHAPTER 1 Common Customs Tariff and tariff classification of goods 29 CHAPTER 2 Origin of goods 31 Section 1 Non-preferential origin 31 Section 2 Preferential origin 31 Section 3 Determination of origin of specific goods 32 CHAPTER 3 Value of goods for customs purposes 33 TITLE III CUSTOMS DEBT AND GUARANTEES 35 CHAPTER 1 Incurrence of a customs debt 35 Section 1 Customs debt on import 35 Section 2 Customs debt on export 37 Section 3 Provisions common to customs debts incurred on import and export 38 CHAPTER 2 Guarantee for a potential or existing customs debt 39 CHAPTER 3 Recovery, payment, repayment and remission of the amount of import or export duty 42 Section 1 Determination of the amount of import or export duty, notification of the customs debt and entry in the accounts 42 Section 2 Payment of the amount of import or export duty 44 Section 3 Repayment and remission 47 CHAPTER 4 Extinguishment of a customs debt 50 TITLE IV GOODS BROUGHT INTO THE CUSTOMS TERRITORY OF THE UNION 51 CHAPTER 1 Entry summary declaration 51 CHAPTER 2 Arrival of goods 53 Section 1 Entry of goods into the customs territory of the union 53 Section 2 Presentation, unloading and examination of goods 54 Section 3 Temporary storage of goods 55 TITLE V GENERAL RULES ON CUSTOMS STATUS, PLACING GOODS UNDER A CUSTOMS PROCEDURE, VERIFICATION, RELEASE AND DISPOSAL OF GOODS 58 CHAPTER 1 Customs status of goods 58 CHAPTER 2 Placing goods under a customs procedure 59 Section 1 General provisions 59 Section 2 Standard customs declarations 60 Section 3 Simplified customs declarations 60 Section 4 Provisions applying to all customs declarations 61 Section 5 Other simplifications 63 CHAPTER 3 Verification and release of goods 65 Section 1 Verification 65 Section 2 Release 66 CHAPTER 4 Disposal of goods 66 TITLE VI RELEASE FOR FREE CIRCULATION AND RELIEF FROM IMPORT DUTY 68 CHAPTER 1 Release for free circulation 68 CHAPTER 2 Relief from import duty 68 Section 1 Returned goods 68 Section 2 Sea-fishing and products taken from the sea 69 TITLE VII SPECIAL PROCEDURES 70 CHAPTER 1 General provisions 70 CHAPTER 2 Transit 73 Section 1 External and internal transit 73 Section 2 Union transit 75 CHAPTER 3 Storage 76 Section 1 Common provisions 76 Section 2 Customs warehousing 76 Section 3 Free zones 77 CHAPTER 4 Specific use 78 Section 1 Temporary admission 78 Section 2 End-use 79 CHAPTER 5 Processing 80 Section 1 General provisions 80 Section 2 Inward processing 80 Section 3 Outward processing 81 TITLE VIII GOODS TAKEN OUT OF THE CUSTOMS TERRITORY OF THE UNION 82 CHAPTER 1 Formalities prior to the exit of goods 82 CHAPTER 2 Formalities on exit of goods 83 CHAPTER 3 Export and re-export 83 CHAPTER 4 Exit summary declaration 84 CHAPTER 5 Re-export notification 85 CHAPTER 6 Relief from export duty 86 TITLE IX ELECTRONIC SYSTEMS, SIMPLIFICATIONS, DELEGATION OF POWER, COMMITTEE PROCEDURE AND FINAL PROVISIONS 86 CHAPTER 1 Development of electronic systems 86 CHAPTER 2 Simplifications in the application of the customs legislation 86 CHAPTER 3 Delegation of power and committee procedure 87 CHAPTER 4 Final provisions 87 ANNEX CORRELATION TABLE 89 TITLE I GENERAL PROVISIONS CHAPTER 1 Scope of the customs legislation, mission of customs and definitions Article 1 Subject matter and scope 1. This Regulation establishes the Union Customs Code (the Code), laying down the general rules and procedures applicable to goods brought into or taken out of the customs territory of the Union. Without prejudice to international law and conventions and Union legislation in other fields, the Code shall apply uniformly throughout the customs territory of the Union. 2. Certain provisions of the customs legislation may apply outside the customs territory of the Union within the framework of legislation governing specific fields or of international conventions. 3. Certain provisions of the customs legislation, including the simplifications for which it provides, shall apply to the trade in Union goods between parts of the customs territory of the Union to which the provisions of Directive 2006/112/EC or of Directive 2008/118/EC apply and parts of that territory where those provisions do not apply, or to trade between parts of that territory where those provisions do not apply. Article 2 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284 specifying the provisions of the customs legislation and the simplifications thereof with respect to the customs declaration, the proof of the customs status, the use of the internal Union transit procedure insofar as it does not affect a proper application of the fiscal measures at stake, which apply to the trade in Union goods referred to in Article 1(3). Those acts may address particular circumstances pertaining to the trade in Union goods involving only one Member State. Article 3 Mission of customs authorities Customs authorities shall be primarily responsible for the supervision of the Union's international trade, thereby contributing to fair and open trade, to the implementation of the external aspects of the internal market, of the common trade policy and of the other common Union policies having a bearing on trade, and to overall supply chain security. Customs authorities shall put in place measures aimed, in particular, at the following: (a) protecting the financial interests of the Union and its Member States; (b) protecting the Union from unfair and illegal trade while supporting legitimate business activity; (c) ensuring the security and safety of the Union and its residents, and the protection of the environment, where appropriate in close cooperation with other authorities; and (d) maintaining a proper balance between customs controls and facilitation of legitimate trade. Article 4 Customs territory 1. The customs territory of the Union shall comprise the following territories, including their territorial waters, internal waters and airspace: \u2014 the territory of the Kingdom of Belgium, \u2014 the territory of the Republic of Bulgaria, \u2014 the territory of the Czech Republic, \u2014 the territory of the Kingdom of Denmark, except the Faroe Islands and Greenland, \u2014 the territory of the Federal Republic of Germany, except the Island of Heligoland and the territory of B\u00fcsingen (Treaty of 23 November 1964 between the Federal Republic of Germany and the Swiss Confederation), \u2014 the territory of the Republic of Estonia, \u2014 the territory of Ireland, \u2014 the territory of the Hellenic Republic, \u2014 the territory of the Kingdom of Spain, except Ceuta and Melilla, \u2014 the territory of the French Republic, except the French overseas countries and territories to which the provisions of Part Four of the TFEU apply, \u2014 the territory of the Republic of Croatia, \u2014 the territory of the Italian Republic, except the municipalities of Livigno and Campione d'Italia and the national waters of Lake Lugano which are between the bank and the political frontier of the area between Ponte Tresa and Porto Ceresio, \u2014 the territory of the Republic of Cyprus, in accordance with the provisions of the 2003 Act of Accession, \u2014 the territory of the Republic of Latvia, \u2014 the territory of the Republic of Lithuania, \u2014 the territory of the Grand Duchy of Luxembourg, \u2014 the territory of Hungary, \u2014 the territory of Malta, \u2014 the territory of the Kingdom of the Netherlands in Europe, \u2014 the territory of the Republic of Austria, \u2014 the territory of the Republic of Poland, \u2014 the territory of the Portuguese Republic, \u2014 the territory of Romania, \u2014 the territory of the Republic of Slovenia, \u2014 the territory of the Slovak Republic, \u2014 the territory of the Republic of Finland, \u2014 the territory of the Kingdom of Sweden, and \u2014 the territory of the United Kingdom of Great Britain and Northern Ireland and of the Channel Islands and the Isle of Man. 2. The following territories, including their territorial waters, internal waters and airspace, situated outside the territory of the Member States shall, taking into account the conventions and treaties applicable to them, be considered to be part of the customs territory of the Union: (a) FRANCE The territory of Monaco as defined in the Customs Convention signed in Paris on 18 May 1963 (Journal officiel de la R\u00e9publique fran\u00e7aise (Official Journal of the French Republic) of 27 September 1963, p. 8679); (b) CYPRUS The territory of the United Kingdom Sovereign Base Areas of Akrotiri and Dhekelia as defined in the Treaty concerning the Establishment of the Republic of Cyprus, signed in Nicosia on 16 August 1960 (United Kingdom Treaty Series No 4 (1961) Cmnd. 1252). Article 5 Definitions For the purposes of the Code, the following definitions shall apply: (1) \"customs authorities\" means the customs administrations of the Member States responsible for applying the customs legislation and any other authorities empowered under national law to apply certain customs legislation; (2) \"customs legislation\" means the body of legislation made up of all of the following: (a) the Code and the provisions supplementing or implementing it adopted at Union or national level; (b) the Common Customs Tariff; (c) the legislation setting up a Union system of reliefs from customs duty; (d) international agreements containing customs provisions, insofar as they are applicable in the Union; (3) \"customs controls\" means specific acts performed by the customs authorities in order to ensure compliance with the customs legislation and other legislation governing the entry, exit, transit, movement, storage and end-use of goods moved between the customs territory of the Union and countries or territories outside that territory, and the presence and movement within the customs territory of the Union of non-Union goods and goods placed under the end-use procedure; (4) \"person\" means a natural person, a legal person, and any association of persons which is not a legal person but which is recognised under Union or national law as having the capacity to perform legal acts; (5) \"economic operator\" means a person who, in the course of his or her business, is involved in activities covered by the customs legislation; (6) \"customs representative\" means any person appointed by another person to carry out the acts and formalities required under the customs legislation in his or her dealings with customs authorities; (7) \"risk\" means the likelihood and the impact of an event occurring, with regard to the entry, exit, transit, movement or end-use of goods moved between the customs territory of the Union and countries or territories outside that territory and to the presence within the customs territory of the Union of non-Union goods, which would: (a) prevent the correct application of Union or national measures; (b) compromise the financial interests of the Union and its Member States; or (c) pose a threat to the security and safety of the Union and its residents, to human, animal or plant health, to the environment or to consumers; (8) \"customs formalities\" means all the operations which must be carried out by a person and by the customs authorities in order to comply with the customs legislation; (9) \"entry summary declaration\" means the act whereby a person informs the customs authorities, in the prescribed form and manner and within a specific time-limit, that goods are to be brought into the customs territory of the Union; (10) \"exit summary declaration\" means the act whereby a person informs the customs authorities, in the prescribed form and manner and within a specific time-limit, that goods are to be taken out of the customs territory of the Union; (11) \"temporary storage declaration\" means the act whereby a person indicates, in the prescribed form and manner, that goods are in temporary storage; (12) \"customs declaration\" means the act whereby a person indicates, in the prescribed form and manner, a wish to place goods under a given customs procedure, with an indication, where appropriate, of any specific arrangements to be applied; (13) \"re-export declaration\" means the act whereby a person indicates, in the prescribed form and manner, a wish to take non-Union goods, with the exception of those under the free zone procedure or in temporary storage, out of the customs territory of the Union; (14) \"re-export notification\" means the act whereby a person indicates, in the prescribed form and manner, a wish to take non-Union goods which are under the free zone procedure or in temporary storage out of the customs territory of the Union; (15) \"declarant\" means the person lodging a customs declaration, a temporary storage declaration, an entry summary declaration, an exit summary declaration, a re-export declaration or a re-export notification in his or her own name or the person in whose name such a declaration or notification is lodged; (16) \"customs procedure\" means any of the following procedures under which goods may be placed in accordance with the Code: (a) release for free circulation; (b) special procedures; (c) export; (17) 'temporary storage' means the situation of non-Union goods temporarily stored under customs supervision in the period between their presentation to customs and their placing under a customs procedure or re-export; (18) \"customs debt\" means the obligation on a person to pay the amount of import or export duty which applies to specific goods under the customs legislation in force; (19) \"debtor\" means any person liable for a customs debt; (20) \"import duty\" means customs duty payable on the import of goods; (21) \"export duty\" means customs duty payable on the export of goods; (22) \"customs status\" means the status of goods as Union or non-Union goods; (23) \"Union goods\" means goods which fall into any of the following categories: (a) goods wholly obtained in the customs territory of the Union and not incorporating goods imported from countries or territories outside the customs territory of the Union; (b) goods brought into the customs territory of the Union from countries or territories outside that territory and released for free circulation; (c) goods obtained or produced in the customs territory of the Union, either solely from goods referred to in point (b) or from goods referred to in points (a) and (b); (24) \"non-Union goods\" means goods other than those referred to in point 23 or which have lost their customs status as Union goods; (25) \"risk management\" means the systematic identification of risk, including through random checks, and the implementation of all measures necessary for limiting exposure to risk; (26) \"release of goods\" means the act whereby the customs authorities make goods available for the purposes specified for the customs procedure under which they are placed; (27) \"customs supervision\" means action taken in general by the customs authorities with a view to ensuring that customs legislation and, where appropriate, other provisions applicable to goods subject to such action are observed; (28) \"repayment\" means the refunding of an amount of import or export duty that has been paid; (29) \"remission\" means the waiving of the obligation to pay an amount of import or export duty which has not been paid; (30) \"processed products\" means goods placed under a processing procedure which have undergone processing operations; (31) \"person established in the customs territory of the Union\" means: (a) in the case of a natural person, any person who has his or her habitual residence in the customs territory of the Union; (b) in the case of a legal person or an association of persons, any person having its registered office, central headquarters or a permanent business establishment in the customs territory of the Union; (32) \"permanent business establishment\" means a fixed place of business, where both the necessary human and technical resources are permanently present and through which a person's customs-related operations are wholly or partly carried out; (33) \"presentation of goods to customs\" means the notification to the customs authorities of the arrival of goods at the customs office or at any other place designated or approved by the customs authorities and the availability of those goods for customs controls; (34) \"holder of the goods\" means the person who is the owner of the goods or who has a similar right of disposal over them or who has physical control of them; (35) \"holder of the procedure\" means: (a) the person who lodges the customs declaration, or on whose behalf that declaration is lodged; or (b) the person to whom the rights and obligations in respect of a customs procedure have been transferred; (36) \"commercial policy measures\" means non-tariff measures established, as part of the common commercial policy, in the form of Union provisions governing international trade in goods; (37) \"processing operations\" means any of the following: (a) the working of goods, including erecting or assembling them or fitting them to other goods; (b) the processing of goods; (c) the destruction of goods; (d) the repair of goods, including restoring them and putting them in order; (e) the use of goods which are not to be found in the processed products, but which allow or facilitate the production of those products, even if they are entirely or partially used up in the process (production accessories); (38) \"rate of yield\" means the quantity or percentage of processed products obtained from the processing of a given quantity of goods placed under a processing procedure; (39) \"decision\" means any act by the customs authorities pertaining to the customs legislation giving a ruling on a particular case, and having legal effects on the person or persons concerned; (40) \"carrier\" means: (a) in the context of entry, the person who brings the goods, or who assumes responsibility for the carriage of the goods, into the customs territory of the Union. However, (i) in the case of combined transportation, \"carrier\" means the person who operates the means of transport which, once brought into the customs territory of the Union, moves by itself as an active means of transport; (ii) in the case of maritime or air traffic under a vessel-sharing or contracting arrangement, \"carrier\" means the person who concludes a contract and issues a bill of lading or air waybill for the actual carriage of the goods into the customs territory of the Union; (b) in the context of exit, the person who takes the goods, or who assumes responsibility for the carriage of the goods, out of the customs territory of the Union. However: (i) in the case of combined transportation, where the active means of transport leaving the customs territory of the Union is only transporting another means of transport which, after the arrival of the active means of transport at its destination, will move by itself as an active means of transport, 'carrier' means the person who will operate the means of transport which will move by itself once the means of transport leaving the customs territory of the Union has arrived at its destination; (ii) in the case of maritime or air traffic under a vessel-sharing or contracting arrangement, \"carrier\" means the person who concludes a contract, and issues a bill of lading or air waybill, for the actual carriage of the goods out of the customs territory of the Union; (41) \"buying commission\" means a fee paid by an importer to an agent for representing him or her in the purchase of goods being valued. CHAPTER 2 Rights and obligations of persons with regard to the customs legislation Section 1 Provision of information Article 6 Means for the exchange and storage of information and common data requirements 1. All exchanges of information, such as declarations, applications or decisions, between customs authorities and between economic operators and customs authorities, and the storage of such information, as required under the customs legislation, shall be made using electronic data-processing techniques. 2. Common data requirements shall be drawn up for the purpose of the exchange and storage of information referred to in paragraph 1. 3. Means for the exchange and storage of information, other than the electronic data-processing techniques referred to in paragraph 1, may be used as follows: (a) on a permanent basis where duly justified by the type of traffic or where the use of electronic data-processing techniques is not appropriate for the customs formalities concerned; (b) on a temporary basis, in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators. 4. By way of derogation from paragraph 1, the Commission may adopt in exceptional cases decisions allowing one or several Member States to use means for the exchange and storage of information other than electronic data-processing techniques. Such a decision on a derogation shall be justified by the specific situation of the Member State requesting it and the derogation shall be granted for a specific period of time. The derogation shall be reviewed periodically and may be extended for further specific periods of time upon further application by the Member State to which it is addressed. It shall be revoked where no longer justified. The derogation shall not affect the exchange of information between the Member State to which it is addressed and other Member States nor the exchange and storage of information in other Member States for the purpose of the application of the customs legislation. Article 7 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the following: (a) the common data requirements referred to in Article 6(2), taking into account the need to accomplish the customs formalities laid down in the customs legislation and the nature and purpose of the exchange and storage of information referred to in Article 6(1); (b) the specific cases where means for the exchange and storage of information, other than electronic data-processing techniques, may be used in accordance with point (a) of Article 6(3); (c) the type of information and the particulars that are to be contained in the records referred to in Articles 148(4) and 214(1). Article 8 Conferral of implementing powers 1. The Commission shall specify, by means of implementing acts: (a) where necessary, the format and code of the common data requirements referred to in Article 6(2); (b) the procedural rules on the exchange and storage of information which can be made by means other than the electronic data-processing techniques referred to in Article 6(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt the decisions on derogations referred to in Article 6(4) by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 285(2). Article 9 Registration 1. Economic operators established in the customs territory of the Union shall register with the customs authorities responsible for the place where they are established. 2. In specific cases, economic operators which are not established in the customs territory of the Union shall register with the customs authorities responsible for the place where they first lodge a declaration or apply for a decision. 3. Persons other than economic operators shall not be required to register with the customs authorities unless otherwise provided. Where persons referred to in the first subparagraph are required to register, the following shall apply: (a) where they are established in the customs territory of the Union, they shall register with the customs authorities responsible for the place where they are established; (b) where they are not established in the customs territory of the Union, they shall register with the customs authorities responsible for the place where they first lodge a declaration or apply for a decision. 4. In specific cases, the customs authorities shall invalidate the registration. Article 10 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the cases referred to in Article 9(2), where economic operators which are not established in the customs territory of the Union are required to register with the customs authorities; (b) the cases referred to in the first subparagraph of Article 9(3), where persons other than economic operators are required to register with the customs authorities; (c) the cases referred to in Article 9(4) where the customs authorities invalidate a registration. Article 11 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the customs authority responsible for the registration referred to in Article 9. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 12 Communication of information and data protection 1. All information acquired by the customs authorities in the course of performing their duty which is by its nature confidential or which is provided on a confidential basis shall be covered by the obligation of professional secrecy. Except as provided for in Article 47(2), such information shall not be disclosed by the competent authorities without the express permission of the person or authority that provided it. Such information may, however, be disclosed without permission where the customs authorities are obliged or authorised to do so pursuant to the provisions in force, particularly in respect of data protection, or in connection with legal proceedings. 2. Confidential information referred to in paragraph 1 may be communicated to the customs authorities and other competent authorities of countries or territories outside the customs territory of the Union for the purpose of customs cooperation with those countries or territories in the framework of an international agreement or Union legislation in the area of the common commercial policy. 3. Any disclosure or communication of information as referred to in paragraphs 1 and 2 shall ensure an adequate level of data protection in full compliance with data protection provisions in force. Article 13 Exchange of additional information between customs authorities and economic operators 1. Customs authorities and economic operators may exchange any information not specifically required under the customs legislation, in particular for the purpose of mutual cooperation in the identification and counteraction of risk. That exchange may take place under a written agreement and may include access to the computer systems of economic operators by the customs authorities. 2. Any information provided by one party to the other in the course of the cooperation referred to in paragraph 1 shall be confidential unless both parties agree otherwise. Article 14 Provision of information by the customs authorities 1. Any person may request information concerning the application of the customs legislation from the customs authorities. Such a request may be refused where it does not relate to an activity pertaining to international trade in goods that is actually envisaged. 2. Customs authorities shall maintain a regular dialogue with economic operators and other authorities involved in international trade in goods. They shall promote transparency by making the customs legislation, general administrative rulings and application forms freely available, wherever practical without charge, and through the Internet. Article 15 Provision of information to the customs authorities 1. Any person directly or indirectly involved in the accomplishment of customs formalities or in customs controls shall, at the request of the customs authorities and within any time-limit specified, provide those authorities with all the requisite documents and information, in an appropriate form, and all the assistance necessary for the completion of those formalities or controls. 2. The lodging of a customs declaration, temporary storage declaration, entry summary declaration, exit summary declaration, re-export declaration or re-export notification by a person to the customs authorities, or the submission of an application for an authorisation or any other decision, shall render the person concerned responsible for all of the following: (a) the accuracy and completeness of the information given in the declaration, notification or application; (b) the authenticity, accuracy and validity of any document supporting the declaration, notification or application; (c) where applicable, compliance with all of the obligations relating to the placing of the goods in question under the customs procedure concerned, or to the conduct of the authorised operations. The first subparagraph shall also apply to the provision of any information in any other form required by, or given to, the customs authorities. Where the declaration or notification is lodged, the application is submitted, or information is provided, by a customs representative of the person concerned, as referred to in Article 18, that customs representative shall also be bound by the obligations set out in the first subparagraph of this paragraph. Article 16 Electronic systems 1. Member States shall cooperate with the Commission to develop, maintain and employ electronic systems for the exchange of information between customs authorities and with the Commission and for the storage of such information, in accordance with the Code. 2. Member States to which a derogation has been granted in accordance with Article 6(4) shall not be required to develop, maintain and employ within the scope of that derogation the electronic systems referred to in paragraph 1 of this Article. Article 17 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the technical arrangements for developing, maintaining and employing the electronic systems referred to in Article 16(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Customs representation Article 18 Customs representative 1. Any person may appoint a customs representative. Such representation may be either direct, in which case the customs representative shall act in the name of and on behalf of another person, or indirect, in which case the customs representative shall act in his or her own name but on behalf of another person. 2. A customs representative shall be established within the customs territory of the Union. Except where otherwise provided, that requirement shall be waived where the customs representative acts on behalf of persons who are not required to be established within the customs territory of the Union. 3. Member States may determine, in accordance with Union law, the conditions under which a customs representative may provide services in the Member State where he or she is established. However, without prejudice to the application of less stringent criteria by the Member State concerned, a customs representative who complies with the criteria laid down in points (a) to (d) of Article 39 shall be entitled to provide such services in a Member State other than the one where he or she is established. 4. Member States may apply the conditions determined in accordance with the first sentence of paragraph 3 to customs representatives not established within the customs territory of the Union. Article 19 Empowerment 1. When dealing with the customs authorities, a customs representative shall state that he or she is acting on behalf of the person represented and shall specify whether the representation is direct or indirect. Persons who fail to state that they are acting as a customs representative or who state that they are acting as a customs representative without being empowered to do so shall be deemed to be acting in their own name and on their own behalf. 2. The customs authorities may require persons stating that they are acting as a customs representative to provide evidence of their empowerment by the person represented. In specific cases, the customs authorities shall not require such evidence to be provided. 3. The customs authorities shall not require a person acting as a customs representative, carrying out acts and formalities on a regular basis, to produce on every occasion evidence of empowerment, provided that such person is in a position to produce such evidence on request by the customs authorities. Article 20 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the cases where the waiver referred to in the second subparagraph of Article 18(2) does not apply; (b) the cases where the evidence of empowerment referred to in the first subparagraph of Article 19(2) is not required by the customs authorities. Article 21 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on the conferral and proving of the entitlement referred to in Article 18(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 3 Decisions relating to the application of the customs legislation Article 22 Decisions taken upon application 1. Where a person applies for a decision relating to the application of the customs legislation, that person shall supply all the information required by the competent customs authorities in order to enable them to take that decision. A decision may also be applied for by, and taken with regard to, several persons, in accordance with the conditions laid down in the customs legislation. Except where otherwise provided, the competent customs authority shall be that of the place where the applicant's main accounts for customs purposes are held or accessible, and where at least part of the activities to be covered by the decision are to be carried out. 2. Customs authorities shall, without delay and at the latest within 30 days of receipt of the application for a decision, verify whether the conditions for the acceptance of that application are fulfilled. Where the customs authorities establish that the application contains all the information required in order for them to be able to take the decision, they shall communicate its acceptance to the applicant within the period specified in the first subparagraph. 3. The competent customs authority shall take a decision as referred to in paragraph 1, and shall notify the applicant without delay, and at the latest within 120 days of the date of acceptance of the application, except where otherwise provided Where the customs authorities are unable to comply with the time-limit for taking a decision, they shall inform the applicant of that fact before the expiry of that time-limit, stating the reasons and indicating the further period of time which they consider necessary in order to take a decision. Except where otherwise provided, that further period of time shall not exceed 30 days. Without prejudice to the second subparagraph, the customs authorities may extend the time-limit for taking a decision, as laid down in the customs legislation, where the applicant requests an extension to carry out adjustments in order to ensure the fulfilment of the conditions and criteria. Those adjustments and the further period of time necessary to carry them out shall be communicated to the customs authorities, which shall decide on the extension. 4. Except where otherwise specified in the decision or in the customs legislation, the decision shall take effect from the date on which the applicant receives it, or is deemed to have received it. Except in the cases provided for in Article 45(2), decisions adopted shall be enforceable by the customs authorities from that date. 5. Except where otherwise provided in the customs legislation, the decision shall be valid without limitation of time. 6. Before taking a decision which would adversely affect the applicant, the customs authorities shall communicate the grounds on which they intend to base their decision to the applicant, who shall be given the opportunity to express his or her point of view within a period prescribed from the date on which he or she receives that communication or is deemed to have received it. Following the expiry of that period, the applicant shall be notified, in the appropriate form, of the decision. The first subparagraph shall not apply in any of the following cases: (a) where it concerns a decision referred to in Article 33(1); (b) in the event of refusal of the benefit of a tariff quota where the specified tariff quota volume is reached, as referred to in the first subparagraph of Article 56(4); (c) where the nature or the level of a threat to the security and safety of the Union and its residents, to human, animal or plant health, to the environment or to consumers so requires; (d) where the decision aims at securing the implementation of another decision for which the first subparagraph has been applied, without prejudice to the law of the Member State concerned; (e) where it would prejudice investigations initiated for the purpose of combating fraud; (f) in other specific cases. 7. A decision which adversely affects the applicant shall set out the grounds on which it is based and shall refer to the right of appeal provided for in Article 44. Article 23 Management of decisions taken upon application 1. The holder of the decision shall comply with the obligations resulting from that decision. 2. The holder of the decision shall inform the customs authorities without delay of any factor arising after the decision was taken, which may influence its continuation or content. 3. Without prejudice to provisions laid down in other fields which specify the cases in which decisions are invalid or become null and void, the customs authorities which took a decision may at any time annul, amend or revoke it where it does not conform to the customs legislation. 4. In specific cases the customs authorities shall carry out the following: (a) re-assess a decision; (b) suspend a decision which is not to be annulled, revoked or amended. 5. The customs authorities shall monitor the conditions and criteria to be fulfilled by the holder of a decision. They shall also monitor compliance with the obligations resulting from that decision. Where the holder of the decision has been established for less than three years, the customs authorities shall closely monitor it during the first year after the decision is taken. Article 24 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the exceptions to the third subparagraph of Article 22(1); (b) the conditions for the acceptance of an application, referred to in Article 22(2); (c) the time-limit to take a specific decision, including the possible extension of that time-limit, in accordance with Article 22(3); (d) the cases, referred to in Article 22(4), where the decision takes effect from a date which is different from the date on which the applicant receives it or is deemed to have received it; (e) the cases, referred to in Article 22(5), where the decision is not valid without limitation of time; (f) the duration of the period referred to in the first subparagraph of Article 22(6); (g) the specific cases, referred to in point (f) of the second subparagraph of Article 22(6), where the applicant is given no opportunity to express his or her point of view; (h) the cases and the rules for re-assessing and suspending decisions in accordance with Article 23(4); Article 25 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) the submission and the acceptance of the application for a decision, referred to in Article 22(1) and (2); (b) taking the decision referred to in Article 22, including, where appropriate, the consultation of the Member States concerned; (c) monitoring a decision, in accordance with Article 23(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 26 Union-wide validity of decisions Except where the effect of a decision is limited to one or several Member States, decisions relating to the application of the customs legislation shall be valid throughout the customs territory of the Union. Article 27 Annulment of favourable decisions 1. The customs authorities shall annul a decision favourable to the holder of the decision if all the following conditions are fulfilled: (a) the decision was taken on the basis of incorrect or incomplete information; (b) the holder of the decision knew or ought reasonably to have known that the information was incorrect or incomplete; (c) if the information had been correct and complete, the decision would have been different. 2. The holder of the decision shall be notified of its annulment. 3. Annulment shall take effect from the date on which the initial decision took effect, unless otherwise specified in the decision in accordance with the customs legislation. Article 28 Revocation and amendment of favourable decisions 1. A favourable decision shall be revoked or amended where, in cases other than those referred to in Article 27: (a) one or more of the conditions for taking that decision were not or are no longer fulfilled; or (b) upon application by the holder of the decision. 2. Except where otherwise provided, a favourable decision addressed to several persons may be revoked only in respect of a person who fails to fulfil an obligation imposed under that decision. 3. The holder of the decision shall be notified of its revocation or amendment. 4. Article 22(4) shall apply to the revocation or amendment of the decision. However, in exceptional cases where the legitimate interests of the holder of the decision so require, the customs authorities may defer the date on which revocation or amendment takes effect up to one year. That date shall be indicated in the revoking or amending decision. Article 29 Decisions taken without prior application Except when a customs authority acts as a judicial authority, Article 22(4), (5), (6) and (7), Article 23(3) and Articles 26, 27 and 28 shall also apply to decisions taken by the customs authorities without prior application by the person concerned. Article 30 Limitations applicable to decisions on goods placed under a customs procedure or in temporary storage Except where the person concerned so requests, the revocation, amendment or suspension of a favourable decision shall not affect goods which, at the moment where the revocation, amendment or suspension takes effect, have already been placed and are still under a customs procedure or in temporary storage by virtue of the revoked, amended or suspended decision. Article 31 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the cases, referred to in Article 28(2), where a favourable decision addressed to several persons may be revoked also in respect of persons other than the person who fails to fulfil an obligation imposed under that decision; (b) the exceptional cases, in which the customs authorities may defer the date on which revocation or amendment takes effect in accordance with the second subparagraph of Article 28(4). Article 32 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for annulling, revoking or amending favourable decisions. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 33 Decisions relating to binding information 1. The customs authorities shall, upon application, take decisions relating to binding tariff information (BTI decisions), or decisions relating to binding origin information (BOI decisions). Such an application shall not be accepted in any of the following circumstances: (a) where the application is made, or has already been made, at the same or another customs office, by or on behalf of the holder of a decision in respect of the same goods and, for BOI decisions, under the same circumstances determining the acquisition of origin; (b) where the application does not relate to any intended use of the BTI or BOI decision or any intended use of a customs procedure. 2. BTI or BOI decisions shall be binding, only in respect of the tariff classification or determination of the origin of goods: (a) on the customs authorities, as against the holder of the decision, only in respect of goods for which customs formalities are completed after the date on which the decision takes effect; (b) on the holder of the decision, as against the customs authorities, only with effect from the date on which he or she receives, or is deemed to have received, notification of the decision. 3. BTI or BOI decisions shall be valid for a period of three years from the date on which the decision takes effect. 4. For the application of a BTI or BOI decision in the context of a particular customs procedure, the holder of the decision shall be able to prove that: (a) in the case of a BTI decision, the goods declared correspond in every respect to those described in the decision; (b) in the case of a BOI decision, the goods in question and the circumstances determining the acquisition of origin correspond in every respect to the goods and the circumstances described in the decision. Article 34 Management of decisions relating to binding information 1. A BTI decision shall cease to be valid before the end of the period referred to in Article 33(3) where it no longer conforms to the law, as a result of either of the following: (a) the adoption of an amendment to the nomenclatures referred to in points (a) and (b) of Article 56(2); (b) the adoption of measures referred to in Article 57(4); with effect from the date of application of such amendment or measures. 2. A BOI decision shall cease to be valid before the end of the period referred to in Article 33(3) in any of the following cases: (a) where a regulation is adopted or an agreement is concluded by, and becomes applicable in, the Union, and the BOI decision no longer conforms to the law thereby laid down, with effect from the date of application of that regulation or agreement; (b) where it is no longer compatible with the Agreement on Rules of Origin established in the World Trade Organisation (WTO) or with the explanatory notes or an origin opinion adopted for the interpretation of that Agreement, with effect from the date of their publication in the Official Journal of the European Union. 3. BTI or BOI decisions shall not cease to be valid with retroactive effect. 4. By way of derogation from Article 23(3) and Article 27, BTI and BOI decisions shall be annulled where they are based on inaccurate or incomplete information from the applicants. 5. BTI and BOI decisions shall be revoked in accordance with Article 23(3) and Article 28. However, such decisions shall not be revoked upon application by the holder of the decision. 6. BTI and BOI decisions may not be amended. 7. The customs authorities shall revoke BTI decisions: (a) where they are no longer compatible with the interpretation of any of the nomenclatures referred to in points (a) and (b) of Article 56(2) resulting from any of the following: (i) explanatory notes referred to in the second indent of point (a) of Article 9(1) of Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (13), with effect from the date of their publication in the Official Journal of the European Union; (ii) a judgment of the Court of Justice of the European Union, with effect from the date of publication of the operative part of the judgment in the Official Journal of the European Union; (iii) classification decisions, classification opinions or amendments of the explanatory notes to the Nomenclature of the Harmonized Commodity Description and Coding System, adopted by the Organization set-up by the Convention establishing a Customs Co-operation Council, done at Brussels on 15 December 1950, with effect from the date of publication of the Commission Communication in the 'C' series of the Official Journal of the European Union; or (b) in other specific cases. 8. BOI decisions shall be revoked: (a) where they are no longer compatible with a judgment of the Court of Justice of the European Union, with effect from the date of publication of the operative part of the judgment in the Official Journal of the European Union; or (b) in other specific cases. 9. Where point (b) of paragraph 1 or paragraphs 2, 7 or 8 apply, a BTI or BOI decision may still be used in respect of binding contracts which were based upon that decision and were concluded before it ceased to be valid or was revoked. That extended use shall not apply where a BOI decision is taken for goods to be exported. The extended use referred to in the first subparagraph shall not exceed six months from the date on which the BTI or BOI decision ceases to be valid or is revoked. However, a measure referred to in Article 57(4) or in Article 67 may exclude that extended use or lay down a shorter period of time. In the case of products for which an import or export certificate is submitted when customs formalities are carried out, the period of six months shall be replaced by the period of validity of the certificate. In order to benefit from the extended use of a BTI or BOI decision, the holder of that decision shall lodge an application to the customs authority that took the decision within 30 days of the date on which it ceases to be valid or is revoked, indicating the quantities for which a period of extended use is requested and the Member State or Member States in which goods will be cleared under the period of extended use. That customs authority shall take a decision on the extended use and notify the holder, without delay, and at the latest within 30 days of the date on which it receives all the information required in order to enable it to take that decision. 10. The Commission shall notify the customs authorities where: (a) the taking of BTI and BOI decisions, for goods whose correct and uniform tariff classification or determination of origin is not ensured, is suspended; or (b) the suspension referred to in point (a) is withdrawn. 11. The Commission may adopt decisions requesting Member States to revoke BTI or BOI decisions, to ensure a correct and uniform tariff classification or determination of the origin of goods. Article 35 Decisions relating to binding information with regard to other factors In specific cases, the customs authorities shall, upon application, take decisions relating to binding information with regard to other factors referred to in Title II, on the basis of which import or export duty and other measures in respect of trade in goods are applied. Article 36 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the specific cases referred to in point (b) of Article 34(7) and point (b) of Article 34(8), where BTI and BOI decisions are to be revoked; (b) the cases referred to in Article 35, where decisions relating to binding information are taken with regard to other factors on the basis of which import or export duty and other measures in respect of trade in goods are applied. Article 37 Conferral of implementing powers 1. The Commission shall adopt, by means of implementing acts, the procedural rules for: (a) using a BTI or BOI decision after it ceases to be valid or is revoked, in accordance with Article 34(9); (b) the Commission to notify the customs authorities in accordance with points (a) and (b) of Article 34(10); (c) using decisions referred to in Article 35 and determined in accordance with point (b) of Article 36 after they cease to be valid; (d) suspending decisions referred to in Article 35 and determined in accordance with point (b) of Article 36 and notifying the suspension or the withdrawal of the suspension to the customs authorities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt, by means of implementing acts, the decisions requesting Member States to revoke: (a) decisions referred to in Article 34(11); (b) decisions referred to in Article 35 and determined in accordance with point (b) of Article 36. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 285(2). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. Section 4 Authorised economic operator Article 38 Application and authorisation 1. An economic operator who is established in the customs territory of the Union and who meets the criteria set out in Article 39 may apply for the status of authorised economic operator. The customs authorities shall, following consultation with other competent authorities if necessary, grant that status, which shall be subject to monitoring. 2. The status of authorised economic operator shall consist in the following types of authorisations: (a) that of an authorised economic operator for customs simplifications, which shall enable the holder to benefit from certain simplifications in accordance with the customs legislation; or (b) that of an authorised economic operator for security and safety that shall entitle the holder to facilitations relating to security and safety. 3. Both types of authorisations referred to in paragraph 2 may be held at the same time. 4. The status of authorised economic operator shall, subject to Articles 39, 40 and 41, be recognised by the customs authorities in all Member States. 5. Customs authorities shall, on the basis of the recognition of the status of authorised economic operator for customs simplifications and provided that the requirements related to a specific type of simplification provided for in the customs legislation are fulfilled, authorise the operator to benefit from that simplification. Customs authorities shall not re-examine those criteria which have already been examined when granting the status of authorised economic operator. 6. The authorised economic operator referred to in paragraph 2 shall enjoy more favourable treatment than other economic operators in respect of customs controls according to the type of authorisation granted, including fewer physical and document-based controls. 7. The customs authorities shall grant benefits resulting from the status of authorised economic operator to persons established in countries or territories outside the customs territory of the Union, who fulfil conditions and comply with obligations defined by the relevant legislation of those countries or territories, insofar as those conditions and obligations are recognised by the Union as equivalent to those imposed to authorised economic operators established in the customs territory of the Union. Such a granting of benefits shall be based on the principle of reciprocity unless otherwise decided by the Union, and shall be supported by an international agreement or Union legislation in the area of the common commercial policy. Article 39 Granting of status The criteria for the granting of the status of authorised economic operator shall be the following: (a) the absence of any serious infringement or repeated infringements of customs legislation and taxation rules, including no record of serious criminal offences relating to the economic activity of the applicant; (b) the demonstration by the applicant of a high level of control of his or her operations and of the flow of goods, by means of a system of managing commercial and, where appropriate, transport records, which allows appropriate customs controls; (c) financial solvency, which shall be deemed to be proven where the applicant has good financial standing, which enables him or her to fulfil his or her commitments, with due regard to the characteristics of the type of business activity concerned; (d) with regard to the authorisation referred to in point (a) of Article 38(2), practical standards of competence or professional qualifications directly related to the activity carried out; and (e) with regard to the authorisation referred to in point (b) of Article 38(2), appropriate security and safety standards, which shall be considered as fulfilled where the applicant demonstrates that he or she maintains appropriate measures to ensure the security and safety of the international supply chain including in the areas of physical integrity and access controls, logistical processes and handling of specific types of goods, personnel and identification of his or her business partners. Article 40 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the following: (a) the simplifications referred to in point (a) of Article 38(2); (b) the facilitations referred to in point (b) of Article 38(2); (c) the more favourable treatment referred to in Article 38(6). Article 41 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, the modalities for the application of the criteria referred to in Article 39. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 5 Penalties Article 42 Application of penalties 1. Each Member State shall provide for penalties for failure to comply with the customs legislation. Such penalties shall be effective, proportionate and dissuasive. 2. Where administrative penalties are applied, they may take, inter alia, one or both of the following forms: (a) a pecuniary charge by the customs authorities, including, where appropriate, a settlement applied in place of and in lieu of a criminal penalty; (b) the revocation, suspension or amendment of any authorisation held by the person concerned. 3. Member States shall notify the Commission, within 180 days from the date of application of this Article, as determined in accordance with Article 288(2), of the national provisions in force, as envisaged in paragraph 1 of this Article, and shall notify it without delay of any subsequent amendment affecting those provisions. Section 6 Appeals Article 43 Decisions taken by a judicial authority Articles 44 and 45 shall not apply to appeals lodged with a view to the annulment, revocation or amendment of a decision relating to the application of the customs legislation taken by a judicial authority, or by customs authorities acting as judicial authorities. Article 44 Right of appeal 1. Any person shall have the right to appeal against any decision taken by the customs authorities relating to the application of the customs legislation which concerns him or her directly and individually. Any person who has applied to the customs authorities for a decision and has not obtained a decision on that application within the time-limits referred to in Article 22(3) shall also be entitled to exercise the right of appeal. 2. The right of appeal may be exercised in at least two steps: (a) initially, before the customs authorities or a judicial authority or other body designated for that purpose by the Member States; (b) subsequently, before a higher independent body, which may be a judicial authority or an equivalent specialised body, according to the provisions in force in the Member States. 3. The appeal shall be lodged in the Member State where the decision was taken or was applied for. 4. Member States shall ensure that the appeals procedure enables the prompt confirmation or correction of decisions taken by the customs authorities. Article 45 Suspension of implementation 1. The submission of an appeal shall not cause implementation of the disputed decision to be suspended. 2. The customs authorities shall, however, suspend implementation of such a decision in whole or in part where they have good reason to believe that the disputed decision is inconsistent with the customs legislation or that irreparable damage is to be feared for the person concerned. 3. In the cases referred to in paragraph 2, where the disputed decision has the effect of causing import or export duty to be payable, suspension of implementation of that decision shall be conditional upon the provision of a guarantee, unless it is established, on the basis of a documented assessment, that such a guarantee would be likely to cause the debtor serious economic or social difficulties. Section 7 Control of goods Article 46 Risk management and customs controls 1. The customs authorities may carry out any customs controls they deem necessary. Customs controls may in particular consist of examining goods, taking samples, verifying the accuracy and completeness of the information given in a declaration or notification and the existence, authenticity, accuracy and validity of documents, examining the accounts of economic operators and other records, inspecting means of transport, inspecting luggage and other goods carried by or on persons and carrying out official enquiries and other similar acts. 2. Customs controls, other than random checks, shall primarily be based on risk analysis using electronic data-processing techniques, with the purpose of identifying and evaluating the risks and developing the necessary counter-measures, on the basis of criteria developed at national, Union and, where available, international level. 3. Customs controls shall be performed within a common risk management framework, based upon the exchange of risk information and risk analysis results between customs administrations and establishing common risk criteria and standards, control measures and priority control areas. Controls based upon such information and criteria shall be carried out without prejudice to other controls carried out in accordance with paragraph 1 or with other provisions in force. 4. Customs authorities shall undertake risk management to differentiate between the levels of risk associated with goods subject to customs control or supervision and to determine whether the goods will be subject to specific customs controls, and if so, where. The risk management shall include activities such as collecting data and information, analysing and assessing risk, prescribing and taking action and regularly monitoring and reviewing that process and its outcomes, based on international, Union and national sources and strategies. 5. Customs authorities shall exchange risk information and risk analysis results where: (a) the risks are assessed by a customs authority as being significant and requiring customs control and the results of the control establish that the event triggering the risks has occurred; or (b) the control results do not establish that the event triggering the risks has occurred, but the customs authority concerned considers the threat to present a high risk elsewhere in the Union. 6. For the establishment of the common risk criteria and standards, the control measures and the priority control areas referred to in paragraph 3, account shall be taken of all of the following: (a) the proportionality to the risk; (b) the urgency of the necessary application of the controls; (c) the probable impact on trade flow, on individual Member States and on control resources. 7. The common risk criteria and standards referred to in paragraph 3 shall include all of the following: (a) a description of the risks; (b) the factors or indicators of risk to be used to select goods or economic operators for customs control; (c) the nature of customs controls to be undertaken by the customs authorities; (d) the duration of the application of the customs controls referred to in point (c). 8. Priority control areas shall cover particular customs procedures, types of goods, traffic routes, modes of transport or economic operators which are subject to increased levels of risk analysis and customs controls during a certain period, without prejudice to other controls usually carried out by the customs authorities. Article 47 Cooperation between authorities 1. Where, in respect of the same goods, controls other than customs controls are to be performed by competent authorities other than the customs authorities, customs authorities shall, in close cooperation with those other authorities, endeavour to have those controls performed, wherever possible, at the same time and place as customs controls (one-stop-shop), with customs authorities having the coordinating role in achieving this. 2. In the framework of the controls referred to in this Section, customs and other competent authorities may, where necessary for the purposes of minimising risk and combating fraud, exchange with each other and with the Commission data received in the context of the entry, exit, transit, movement, storage and end-use of goods, including postal traffic, moved between the customs territory of the Union and countries or territories outside the customs territory of the Union, the presence and movement within the customs territory of the Union of non-Union goods and goods placed under the end-use procedure, and the results of any control. Customs authorities and the Commission may also exchange such data with each other for the purpose of ensuring a uniform application of the customs legislation. Article 48 Post-release control For the purpose of customs controls, the customs authorities may verify the accuracy and completeness of the information given in a customs declaration, temporary storage declaration, entry summary declaration, exit summary declaration, re-export declaration or re-export notification, and the existence, authenticity, accuracy and validity of any supporting document and may examine the accounts of the declarant and other records relating to the operations in respect of the goods in question or to prior or subsequent commercial operations involving those goods after having released them. Those authorities may also examine such goods and/or take samples where it is still possible for them to do so. Such controls may be carried out at the premises of the holder of the goods or of the holder's representative, of any other person directly or indirectly involved in those operations in a business capacity or of any other person in possession of those documents and data for business purposes. Article 49 Intra-Union flights and sea crossings 1. Customs controls or formalities shall be carried out in respect of the cabin and hold baggage of persons either taking an intra-Union flight, or making an intra-Union sea crossing, only where the customs legislation provides for such controls or formalities. 2. Paragraph 1 shall apply without prejudice to either of the following: (a) security and safety checks; (b) checks linked to prohibitions or restrictions. Article 50 Conferral of implementing powers 1. The Commission shall adopt, by means of implementing acts, measures to ensure uniform application of the customs controls, including the exchange of risk information and risk analysis results, the common risk criteria and standards, the control measures and the priority control areas referred to in Article 46(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). On imperative grounds of urgency relating to such measures, duly justified by the need to rapidly update the common risk management framework and adapt the exchange of risk information and analysis, common risk criteria and standards, control measures and priority control areas to the evolution of risks, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 285(5). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. 2. The Commission shall determine, by means of implementing acts, the ports or airports where, in accordance with Article 49, customs controls and formalities are applied to the following: (a) the cabin and hold baggage of persons: (i) taking a flight in an aircraft which comes from a non-Union airport and which, after a stopover at a Union airport, continues to another Union airport; (ii) taking a flight in an aircraft which stops over at a Union airport before continuing to a non-Union airport; (iii) using a maritime service provided by the same vessel and comprising successive legs departing from, calling at or terminating in a non-Union port; (iv) on board pleasure craft and tourist or business aircraft; (b) cabin and hold baggage: (i) arriving at a Union airport on board an aircraft coming from a non-Union airport and transferred at that Union airport to another aircraft proceeding on an intra-Union flight; (ii) loaded at a Union airport onto an aircraft proceeding on an intra-Union flight for transfer at another Union airport to an aircraft whose destination is a non-Union airport. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 8 Keeping of documents and other information, and charges and costs Article 51 Keeping of documents and other information 1. The person concerned shall, for the purposes of customs controls, keep the documents and information referred to in Article 15(1) for at least three years, by any means accessible by and acceptable to the customs authorities. In the case of goods released for free circulation in circumstances other than those referred to in the third subparagraph, or goods declared for export, that period shall run from the end of the year in which the customs declarations for release for free circulation or export are accepted. In the case of goods released for free circulation duty-free or at a reduced rate of import duty on account of their end-use, that period shall run from the end of the year in which they cease to be subject to customs supervision. In the case of goods placed under another customs procedure or of goods in temporary storage, that period shall run from the end of the year in which the customs procedure concerned has been discharged or temporary storage has ended. 2. Without prejudice to Article 103(4), where a customs control in respect of a customs debt shows that the relevant entry in the accounts has to be corrected and the person concerned has been notified of this, the documents and information shall be kept for three years beyond the time-limit provided for in paragraph 1 of this Article. Where an appeal has been lodged or where court proceedings have begun, the documents and information shall be kept for the period provided for in paragraph 1 or until the appeals procedure or court proceedings are terminated, whichever is the later. Article 52 Charges and costs 1. Customs authorities shall not impose charges for the performance of customs controls or any other application of the customs legislation during the official opening hours of their competent customs offices. 2. Customs authorities may impose charges or recover costs where specific services are rendered, in particular the following: (a) attendance, where requested, by customs staff outside official office hours or at premises other than customs premises; (b) analyses or expert reports on goods and postal fees for the return of goods to an applicant, particularly in respect of decisions taken pursuant to Article 33 or the provision of information in accordance with Article 14(1); (c) the examination or sampling of goods for verification purposes, or the destruction of goods, where costs other than the cost of using customs staff are involved; (d) exceptional control measures, where these are necessary due to the nature of the goods or to a potential risk. CHAPTER 3 Currency conversion and time-limits Article 53 Currency conversion 1. The competent authorities shall publish and/or make available on the Internet the rate of exchange applicable where the conversion of currency is necessary for one of the following reasons: (a) because factors used to determine the customs value of goods are expressed in a currency other than that of the Member State where the customs value is determined; (b) because the value of the euro is required in national currencies for the purposes of determining the tariff classification of goods and the amount of import and export duty, including value thresholds in the Common Customs Tariff. 2. Where the conversion of currency is necessary for reasons other than those referred to in paragraph 1, the value of the euro in national currencies to be applied within the framework of the customs legislation shall be fixed at least once a year. Article 54 Conferral of implementing powers The Commission shall lay down, by means of implementing acts, rules on currency conversions for the purposes referred to in Article 53(1) and (2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 55 Periods, dates and time-limits 1. Unless otherwise provided, where a period, date or time-limit is laid down in the customs legislation, such period shall not be extended or reduced and such date or time-limit shall not be deferred or brought forward. 2. The rules applicable to periods, dates and time-limits set out in Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time-limits (14) shall apply, except where otherwise provided for in the customs legislation. TITLE II FACTORS ON THE BASIS OF WHICH IMPORT OR EXPORT DUTY AND OTHER MEASURES IN RESPECT OF TRADE IN GOODS ARE APPLIED CHAPTER 1 Common Customs Tariff and tariff classification of goods Article 56 Common Customs Tariff and surveillance 1. Import and export duty due shall be based on the Common Customs Tariff. Other measures prescribed by Union provisions governing specific fields relating to trade in goods shall, where appropriate, be applied in accordance with the tariff classification of those goods. 2. The Common Customs Tariff shall comprise all of the following: (a) the Combined Nomenclature of goods as laid down in Regulation (EEC) No 2658/87; (b) any other nomenclature which is wholly or partly based on the Combined Nomenclature or which provides for further subdivisions to it, and which is established by Union provisions governing specific fields with a view to the application of tariff measures relating to trade in goods; (c) the conventional or normal autonomous customs duty applicable to goods covered by the Combined Nomenclature; (d) the preferential tariff measures contained in agreements which the Union has concluded with certain countries or territories outside the customs territory of the Union or groups of such countries or territories; (e) preferential tariff measures adopted unilaterally by the Union in respect of certain countries or territories outside the customs territory of the Union or groups of such countries or territories; (f) autonomous measures providing for a reduction in, or exemption from, customs duty on certain goods; (g) favourable tariff treatment specified for certain goods, by reason of their nature or end-use, in the framework of measures referred to under points (c) to (f) or (h); (h) other tariff measures provided for by agricultural or commercial or other Union legislation. 3. Where the goods concerned fulfil the conditions included in the measures laid down in points (d) to (g) of paragraph 2, the measures referred to in those provisions shall apply, upon application by the declarant, instead of those provided for in point (c) of that paragraph. Such application may be made retrospectively, provided that the time-limits and conditions laid down in the relevant measure or in the Code are complied with. 4. Where application of the measures referred to in points (d) to (g) of paragraph 2, or the exemption from measures referred to in point (h) thereof, is restricted to a certain volume of imports or exports, such application or exemption shall, in the case of tariff quotas, cease as soon as the specified volume of imports or exports is reached. In the case of tariff ceilings such application shall cease by virtue of a legal act of the Union. 5. The release for free circulation or the export of goods, to which the measures referred to in paragraphs 1 and 2 apply, may be made subject to surveillance. Article 57 Tariff classification of goods 1. For the application of the Common Customs Tariff, tariff classification of goods shall consist in the determination of one of the subheadings or further subdivisions of the Combined Nomenclature under which those goods are to be classified. 2. For the application of non-tariff measures, tariff classification of goods shall consist in the determination of one of the subheadings or further subdivisions of the Combined Nomenclature, or of any other nomenclature which is established by Union provisions and which is wholly or partly based on the Combined Nomenclature or which provides for further subdivisions to it, under which those goods are to be classified. 3. The subheading or further subdivision determined in accordance with paragraphs 1 and 2 shall be used for the purpose of applying the measures linked to that subheading. 4. The Commission may adopt measures to determine the tariff classification of goods in accordance with paragraphs 1 and 2. Article 58 Conferral of implementing powers 1. The Commission shall adopt, by means of implementing acts, measures on the uniform management of the tariff quotas and the tariff ceilings referred to in Article 56(4) and on the management of the surveillance of the release for free circulation or export of goods, referred to in Article 56(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt, by means of implementing acts, the measures referred to in Article 57(4). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). On imperative grounds of urgency relating to such measures, duly justified by the need to rapidly ensure the correct and uniform application of the Combined Nomenclature, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 285(5). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. CHAPTER 2 Origin of goods Section 1 Non-preferential origin Article 59 Scope Articles 60 and 61 shall lay down rules for the determination of the non-preferential origin of goods for the purposes of applying the following: (a) the Common Customs Tariff, with the exception of the measures referred to in points (d) and (e) of Article 56(2); (b) measures, other than tariff measures, established by Union provisions governing specific fields relating to trade in goods; and (c) other Union measures relating to the origin of goods. Article 60 Acquisition of origin 1. Goods wholly obtained in a single country or territory shall be regarded as having their origin in that country or territory. 2. Goods the production of which involves more than one country or territory shall be deemed to originate in the country or territory where they underwent their last, substantial, economically-justified processing or working, in an undertaking equipped for that purpose, resulting in the manufacture of a new product or representing an important stage of manufacture. Article 61 Proof of origin 1. Where an origin has been indicated in the customs declaration pursuant to the customs legislation, the customs authorities may require the declarant to prove the origin of the goods. 2. Where proof of origin of goods is provided pursuant to the customs legislation or other Union legislation governing specific fields, the customs authorities may, in the event of reasonable doubt, require any additional evidence needed in order to ensure that the indication of origin complies with the rules laid down by the relevant Union legislation. 3. Where the exigencies of trade so require, a document proving origin may be issued in the Union in accordance with the rules of origin in force in the country or territory of destination or any other method identifying the country where the goods were wholly obtained or underwent their last substantial transformation. Article 62 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, laying down the rules under which goods, whose determination of non-preferential origin is required for the purposes of applying the Union measures referred to in Article 59, are considered as wholly obtained in a single country or territory or to have undergone their last, substantial, economically-justified processing or working, in an undertaking equipped for that purpose, resulting in the manufacture of a new product or representing an important stage of manufacture in a country or territory, in accordance with Article 60. Article 63 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, the procedural rules for the provision and verification of the proof of origin referred to in Article 61. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Preferential origin Article 64 Preferential origin of goods 1. In order to benefit from the measures referred to in points (d) or (e) of Article 56(2) or from non-tariff preferential measures, goods shall comply with the rules on preferential origin referred to in paragraphs 2 to 5 of this Article. 2. In the case of goods benefiting from preferential measures contained in agreements which the Union has concluded with certain countries or territories outside the customs territory of the Union or with groups of such countries or territories, the rules on preferential origin shall be laid down in those agreements. 3. In the case of goods benefiting from preferential measures adopted unilaterally by the Union in respect of certain countries or territories outside the customs territory of the Union or groups of such countries or territories, other than those referred to in paragraph 5, the Commission shall adopt measures laying down the rules on preferential origin. Those rules shall be based either on the criterion that goods are wholly obtained or on the criterion that goods result from sufficient processing or working. 4. In the case of goods benefiting from preferential measures applicable in trade between the customs territory of the Union and Ceuta and Melilla, as contained in Protocol 2 to the 1985 Act of Accession, the rules on preferential origin shall be adopted in accordance with Article 9 of that Protocol. 5. In the case of goods benefiting from preferential measures contained in preferential arrangements in favour of the overseas countries and territories associated with the Union, the rules on preferential origin shall be adopted in accordance with Article 203 TFEU. 6. Upon its own initiative or at the request of a beneficiary country or territory, the Commission may, for certain goods, grant that country or territory a temporary derogation from the rules on preferential origin referred to in paragraph 3. The temporary derogation shall be justified by one of the following reasons: (a) internal or external factors temporarily deprive the beneficiary country or territory of the ability to comply with the rules on preferential origin; (b) the beneficiary country or territory requires time to prepare itself to comply with those rules. A request for derogation shall be made in writing to the Commission by the beneficiary country or territory concerned. The request shall state the reasons, as indicated in the second subparagraph, why derogation is required and shall contain appropriate supporting documents. The temporary derogation shall be limited to the duration of the effects of the internal or external factors giving rise to it or the length of time needed for the beneficiary country or territory to achieve compliance with the rules. Where a derogation is granted, the beneficiary country or territory concerned shall comply with any requirements laid down as to information to be provided to the Commission concerning the use of the derogation and the management of the quantities for which the derogation is granted. Article 65 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, laying down the rules on preferential origin referred to in Article 64(3). Article 66 Conferral of implementing powers The Commission shall adopt by means of implementing acts: (a) the procedural rules, referred to in Article 64(1), to facilitate the establishment in the Union of the preferential origin of goods; (b) a measure granting a beneficiary country or territory the temporary derogation referred to in Article 64(6). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 3 Determination of origin of specific goods Article 67 Measures taken by the Commission The Commission may adopt measures to determine the origin of specific goods in accordance with the rules of origin applicable to those goods. Article 68 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, the measures referred to in Article 67. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). On imperative grounds of urgency relating to such measures, duly justified by the need to rapidly ensure the correct and uniform application of rules of origin, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 285(5). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. CHAPTER 3 Value of goods for customs purposes Article 69 Scope The customs value of goods, for the purposes of applying the Common Customs Tariff and non-tariff measures laid down by Union provisions governing specific fields relating to trade in goods, shall be determined in accordance with Articles 70 and 74. Article 70 Method of customs valuation based on the transaction value 1. The primary basis for the customs value of goods shall be the transaction value, that is the price actually paid or payable for the goods when sold for export to the customs territory of the Union, adjusted, where necessary. 2. The price actually paid or payable shall be the total payment made or to be made by the buyer to the seller or by the buyer to a third party for the benefit of the seller for the imported goods and include all payments made or to be made as a condition of sale of the imported goods. 3. The transaction value shall apply provided that all of the following conditions are fulfilled: (a) there are no restrictions as to the disposal or use of the goods by the buyer, other than any of the following: (i) restrictions imposed or required by a law or by the public authorities in the Union; (ii) limitations of the geographical area in which the goods may be resold; (iii) restrictions which do not substantially affect the customs value of the goods; (b) the sale or price is not subject to some condition or consideration for which a value cannot be determined with respect to the goods being valued; (c) no part of the proceeds of any subsequent resale, disposal or use of the goods by the buyer will accrue directly or indirectly to the seller, unless an appropriate adjustment can be made; (d) the buyer and seller are not related or the relationship did not influence the price. Article 71 Elements of the transaction value 1. In determining the customs value under Article 70, the price actually paid or payable for the imported goods shall be supplemented by: (a) the following, to the extent that they are incurred by the buyer but are not included in the price actually paid or payable for the goods: (i) commissions and brokerage, except buying commissions; (ii) the cost of containers which are treated as being one, for customs purposes, with the goods in question; and (iii) the cost of packing, whether for labour or materials; (b) the value, apportioned as appropriate, of the following goods and services where supplied directly or indirectly by the buyer free of charge or at reduced cost for use in connection with the production and sale for export of the imported goods, to the extent that such value has not been included in the price actually paid or payable: (i) materials, components, parts and similar items incorporated into the imported goods; (ii) tools, dies, moulds and similar items used in the production of the imported goods; (iii) materials consumed in the production of the imported goods; and (iv) engineering, development, artwork, design work, and plans and sketches undertaken elsewhere than in the Union and necessary for the production of the imported goods; (c) royalties and licence fees related to the goods being valued that the buyer must pay, either directly or indirectly, as a condition of sale of the goods being valued, to the extent that such royalties and fees are not included in the price actually paid or payable; (d) the value of any part of the proceeds of any subsequent resale, disposal or use of the imported goods that accrues directly or indirectly to the seller; and (e) the following costs up to the place where goods are brought into the customs territory of the Union: (i) the cost of transport and insurance of the imported goods; and (ii) loading and handling charges associated with the transport of the imported goods. 2. Additions to the price actually paid or payable, pursuant to paragraph 1, shall be made only on the basis of objective and quantifiable data. 3. No additions shall be made to the price actually paid or payable in determining the customs value except as provided in this Article. Article 72 Elements not to be included in the customs value In determining the customs value under Article 70, none of the following shall be included: (a) the cost of transport of the imported goods after their entry into the customs territory of the Union; (b) charges for construction, erection, assembly, maintenance or technical assistance, undertaken after the entry into the customs territory of the Union of the imported goods such as industrial plants, machinery or equipment; (c) charges for interest under a financing arrangement entered into by the buyer and relating to the purchase of the imported goods, irrespective of whether the finance is provided by the seller or another person, provided that the financing arrangement has been made in writing and, where required, the buyer can demonstrate that the following conditions are fulfilled: (i) such goods are actually sold at the price declared as the price actually paid or payable; (ii) the claimed rate of interest does not exceed the level for such transactions prevailing in the country where, and at the time when, the finance was provided; (d) charges for the right to reproduce the imported goods in the Union; (e) buying commissions; (f) import duties or other charges payable in the Union by reason of the import or sale of the goods; (g) notwithstanding point (c) of Article 71(1), payments made by the buyer for the right to distribute or resell the imported goods, if such payments are not a condition of the sale for export to the Union of the goods. Article 73 Simplification The customs authorities may, upon application, authorise that the following amounts be determined on the basis of specific criteria, where they are not quantifiable on the date on which the customs declaration is accepted: (a) amounts which are to be included in the customs value in accordance with Article 70(2); and (b) the amounts referred to in Articles 71 and 72. Article 74 Secondary methods of customs valuation 1. Where the customs value of goods cannot be determined under Article 70, it shall be determined by proceeding sequentially from points (a) to (d) of paragraph 2, until the first point under which the customs value of goods can be determined. The order of application of points (c) and (d) of paragraph 2 shall be reversed if the declarant so requests. 2. The customs value, pursuant to paragraph 1, shall be: (a) the transaction value of identical goods sold for export to the customs territory of the Union and exported at or about the same time as the goods being valued; (b) the transaction value of similar goods sold for export to the customs territory of the Union and exported at or about the same time as the goods being valued; (c) the value based on the unit price at which the imported goods, or identical or similar imported goods, are sold within the customs territory of the Union in the greatest aggregate quantity to persons not related to the sellers; or (d) the computed value, consisting of the sum of: (i) the cost or value of materials and fabrication or other processing employed in producing the imported goods; (ii) an amount for profit and general expenses equal to that usually reflected in sales of goods of the same class or kind as the goods being valued which are made by producers in the country of export for export to the Union; (iii) the cost or value of the elements referred to in point (e) of Article 71(1). 3. Where the customs value cannot be determined under paragraph 1, it shall be determined on the basis of data available in the customs territory of the Union, using reasonable means consistent with the principles and general provisions of all of the following: (a) the agreement on implementation of Article VII of the General Agreement on Tariffs and Trade; (b) Article VII of the General Agreement on Tariffs and Trade; (c) this Chapter. Article 75 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the conditions for granting the authorisation referred to in Article 73. Article 76 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) determining the customs value in accordance with Articles 70(1) and (2) and Articles 71 and 72, including those for adjusting the price actually paid or payable; (b) the application of the conditions referred to in Article 70(3); (c) determining the customs value referred to in Article 74. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). TITLE III CUSTOMS DEBT AND GUARANTEES CHAPTER 1 Incurrence of a customs debt Section 1 Customs debt on import Article 77 Release for free circulation and temporary admission 1. A customs debt on import shall be incurred through the placing of non-Union goods liable to import duty under either of the following customs procedures: (a) release for free circulation, including under the end-use provisions; (b) temporary admission with partial relief from import duty. 2. A customs debt shall be incurred at the time of acceptance of the customs declaration. 3. The declarant shall be the debtor. In the event of indirect representation, the person on whose behalf the customs declaration is made shall also be a debtor. Where a customs declaration in respect of one of the procedures referred to in paragraph 1 is drawn up on the basis of information which leads to all or part of the import duty not being collected, the person who provided the information required to draw up the declaration and who knew, or who ought reasonably to have known, that such information was false shall also be a debtor. Article 78 Special provisions relating to non-originating goods 1. Where a prohibition of drawback of, or exemption from, import duty applies to non-originating goods used in the manufacture of products for which a proof of origin is issued or made out in the framework of a preferential arrangement between the Union and certain countries or territories outside the customs territory of the Union or groups of such countries or territories, a customs debt on import shall be incurred in respect of those non-originating goods, through the acceptance of the re-export declaration relating to the products in question. 2. Where a customs debt is incurred pursuant to paragraph 1, the amount of import duty corresponding to that debt shall be determined under the same conditions as in the case of a customs debt resulting from the acceptance, on the same date, of the customs declaration for release for free circulation of the non-originating goods used in the manufacture of the products in question for the purpose of ending the inward processing procedure. 3. Article 77(2) and (3) shall apply. However, in the case of non-Union goods as referred to in Article 270 the person who lodges the re-export declaration shall be the debtor. In the event of indirect representation, the person on whose behalf the declaration is lodged shall also be a debtor. Article 79 Customs debt incurred through non-compliance 1. For goods liable to import duty, a customs debt on import shall be incurred through non-compliance with any of the following: (a) one of the obligations laid down in the customs legislation concerning the introduction of non-Union goods into the customs territory of the Union, their removal from customs supervision, or the movement, processing, storage, temporary storage, temporary admission or disposal of such goods within that territory; (b) one of the obligations laid down in the customs legislation concerning the end-use of goods within the customs territory of the Union; (c) a condition governing the placing of non-Union goods under a customs procedure or the granting, by virtue of the end-use of the goods, of duty exemption or a reduced rate of import duty. 2. The time at which the customs debt is incurred shall be either of the following: (a) the moment when the obligation the non-fulfilment of which gives rise to the customs debt is not met or ceases to be met; (b) the moment when a customs declaration is accepted for the placing of goods under a customs procedure where it is established subsequently that a condition governing the placing of the goods under that procedure or the granting of a duty exemption or a reduced rate of import duty by virtue of the end-use of the goods was not in fact fulfilled. 3. In cases referred to under points (a) and (b) of paragraph 1, the debtor shall be any of the following: (a) any person who was required to fulfil the obligations concerned; (b) any person who was aware or should reasonably have been aware that an obligation under the customs legislation was not fulfilled and who acted on behalf of the person who was obliged to fulfil the obligation, or who participated in the act which led to the non-fulfilment of the obligation; (c) any person who acquired or held the goods in question and who was aware or should reasonably have been aware at the time of acquiring or receiving the goods that an obligation under the customs legislation was not fulfilled. 4. In cases referred to under point (c) of paragraph 1, the debtor shall be the person who is required to comply with the conditions governing the placing of the goods under a customs procedure or the customs declaration of the goods placed under that customs procedure or the granting of a duty exemption or reduced rate of import duty by virtue of the end-use of the goods. Where a customs declaration in respect of one of the customs procedures referred to in point (c) of paragraph 1 is drawn up, and any information required under the customs legislation relating to the conditions governing the placing of the goods under that customs procedure is given to the customs authorities, which leads to all or part of the import duty not being collected, the person who provided the information required to draw up the customs declaration and who knew, or who ought reasonably to have known, that such information was false shall also be a debtor. Article 80 Deduction of an amount of import duty already paid 1. Where a customs debt is incurred, pursuant to Article 79(1) in respect of goods released for free circulation at a reduced rate of import duty on account of their end-use, the amount of import duty paid when the goods were released for free circulation shall be deducted from the amount of import duty corresponding to the customs debt. The first subparagraph shall apply where a customs debt is incurred in respect of scrap and waste resulting from the destruction of such goods. 2. Where a customs debt is incurred, pursuant to Article 79(1) in respect of goods placed under temporary admission with partial relief from import duty, the amount of import duty paid under partial relief shall be deducted from the amount of import duty corresponding to the customs debt. Section 2 Customs debt on export Article 81 Export and outward processing 1. A customs debt on export shall be incurred through the placing of goods liable to export duty under the export procedure or the outward processing procedure. 2. The customs debt shall be incurred at the time of acceptance of the customs declaration. 3. The declarant shall be the debtor. In the event of indirect representation, the person on whose behalf the customs declaration is made shall also be a debtor. Where a customs declaration is drawn up on the basis of information which leads to all or part of the export duty not being collected, the person who provided the information required for the declaration and who knew, or who should reasonably have known, that such information was false shall also be a debtor. Article 82 Customs debt incurred through non-compliance 1. For goods liable to export duty, a customs debt on export shall be incurred through non-compliance with either of the following: (a) one of the obligations laid down in the customs legislation for the exit of the goods; (b) the conditions under which the goods were allowed to be taken out of the customs territory of the Union with total or partial relief from export duty. 2. The time at which the customs debt is incurred shall be one of the following: (a) the moment at which the goods are actually taken out of the customs territory of the Union without a customs declaration; (b) the moment at which the goods reach a destination other than that for which they were allowed to be taken out of the customs territory of the Union with total or partial relief from export duty; (c) should the customs authorities be unable to determine the moment referred to in point (b), the expiry of the time-limit set for the production of evidence that the conditions entitling the goods to such relief have been fulfilled. 3. In cases referred to under point (a) of paragraph 1, the debtor shall be any of the following: (a) any person who was required to fulfil the obligation concerned; (b) any person who was aware or should reasonably have been aware that the obligation concerned was not fulfilled and who acted on behalf of the person who was obliged to fulfil the obligation; (c) any person who participated in the act which led to the non-fulfilment of the obligation and who was aware or should reasonably have been aware that a customs declaration had not been lodged but should have been. 4. In cases referred to under point (b) of paragraph 1, the debtor shall be any person who is required to comply with the conditions under which the goods were allowed to be taken out of the customs territory of the Union with total or partial relief from export duty. Section 3 Provisions common to customs debts incurred on import and export Article 83 Prohibitions and restrictions 1. The customs debt on import or export shall be incurred even if it relates to goods which are subject to measures of prohibition or restriction on import or export of any kind. 2. However, no customs debt shall be incurred on either of the following: (a) the unlawful introduction into the customs territory of the Union of counterfeit currency; (b) the introduction into the customs territory of the Union of narcotic drugs and psychotropic substances other than where strictly supervised by the competent authorities with a view to their use for medical and scientific purposes. 3. For the purposes of penalties as applicable to customs offences, the customs debt shall nevertheless be deemed to have been incurred where, under the law of a Member State, import or export duty or the existence of a customs debt provide the basis for determining penalties. Article 84 Several debtors Where several persons are liable for payment of the amount of import or export duty corresponding to one customs debt, they shall be jointly and severally liable for payment of that amount. Article 85 General rules for calculating the amount of import or export duty 1. The amount of import or export duty shall be determined on the basis of those rules for calculation of duty which were applicable to the goods concerned at the time at which the customs debt in respect of them was incurred. 2. Where it is not possible to determine precisely the time at which the customs debt is incurred, that time shall be deemed to be the time at which the customs authorities conclude that the goods are in a situation in which a customs debt has been incurred. However, where the information available to the customs authorities enables them to establish that the customs debt had been incurred prior to the time at which they reached that conclusion, the customs debt shall be deemed to have been incurred at the earliest time that such a situation can be established. Article 86 Special rules for calculating the amount of import duty 1. Where costs for storage or usual forms of handling have been incurred within the customs territory of the Union in respect of goods placed under a customs procedure or in temporary storage, such costs or the increase in value shall not be taken into account for the calculation of the amount of import duty where satisfactory proof of those costs is provided by the declarant. However, the customs value, quantity, nature and origin of non-Union goods used in the operations shall be taken into account for the calculation of the amount of import duty. 2. Where the tariff classification of goods placed under a customs procedure changes as a result of usual forms of handling within the customs territory of the Union, the original tariff classification for the goods placed under the procedure shall be applied at the request of the declarant. 3. Where a customs debt is incurred for processed products resulting from the inward processing procedure, the amount of import duty corresponding to such debt shall, at the request of the declarant, be determined on the basis of the tariff classification, customs value, quantity, nature and origin of the goods placed under the inward processing procedure at the time of acceptance of the customs declaration relating to those goods. 4. In specific cases, the amount of import duty shall be determined in accordance with paragraphs 2 and 3 of this Article without a request of the declarant in order to avoid the circumvention of tariff measures referred to in point (h) of Article 56(2). 5. Where a customs debt is incurred for processed products resulting from the outward processing procedure or replacement products as referred to in Article 261(1), the amount of import duty shall be calculated on the basis of the cost of the processing operation undertaken outside the customs territory of the Union. 6. Where the customs legislation provides for a favourable tariff treatment of goods, or for relief or total or partial exemption from import or export duty pursuant to points (d) to (g) of Article 56(2), Articles 203, 204, 205 and 208 or Articles 259 to 262 of this Regulation or pursuant to Council Regulation (EC) No 1186/2009 of 16 November 2009 setting up a Community system of reliefs from customs duty (15) such favourable tariff treatment, relief or exemption shall also apply in cases where a customs debt is incurred pursuant to Articles 79 or 82 of this Regulation, on condition that the failure which led to the incurrence of a customs debt did not constitute an attempt at deception. Article 87 Place where the customs debt is incurred 1. A customs debt shall be incurred at the place where the customs declaration or the re-export declaration referred to in Articles 77, 78 and 81 is lodged. In all other cases, the place where a customs debt is incurred shall be the place where the events from which it arises occur. If it is not possible to determine that place, the customs debt shall be incurred at the place where the customs authorities conclude that the goods are in a situation in which a customs debt is incurred. 2. If the goods have been placed under a customs procedure which has not been discharged or when a temporary storage did not end properly, and the place where the customs debt is incurred cannot be determined pursuant to the second or third subparagraphs of paragraph 1 within a specific time-limit, the customs debt shall be incurred at the place where the goods were either placed under the procedure concerned or were introduced into the customs territory of the Union under that procedure or were in temporary storage. 3. Where the information available to the customs authorities enables them to establish that the customs debt may have been incurred in several places, the customs debt shall be deemed to have been incurred at the place where it was first incurred. 4. If a customs authority establishes that a customs debt has been incurred under Article 79 or Article 82 in another Member State and the amount of import or export duty corresponding to that debt is lower than EUR 10 000, the customs debt shall be deemed to have been incurred in the Member State where the finding was made. Article 88 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the rules for the calculation of the amount of import or export duty applicable to goods for which a customs debt is incurred in the context of a special procedure, which supplement the rules laid down in Articles 85 and 86; (b) the cases referred to in Article 86(4); (c) the time-limit referred to in Article 87(2). CHAPTER 2 Guarantee for a potential or existing customs debt Article 89 General provisions 1. This Chapter shall apply to guarantees both for customs debts which have been incurred and for those which may be incurred, unless otherwise specified. 2. Where the customs authorities require a guarantee for a potential or existing customs debt to be provided, that guarantee shall cover the amount of import or export duty and the other charges due in connection with the import or export of the goods where: (a) the guarantee is used for the placing of goods under the Union transit procedure; or (b) the guarantee may be used in more than one Member State. A guarantee which may not be used outside the Member State where it is required shall be valid only in that Member State and shall cover at least the amount of import or export duty. 3. Where the customs authorities require a guarantee to be provided, it shall be required from the debtor or the person who may become the debtor. They may also permit the guarantee to be provided by a person other than the person from whom it is required. 4. Without prejudice to Article 97, the customs authorities shall require only one guarantee to be provided in respect of specific goods or a specific declaration. The guarantee provided for a specific declaration shall apply to the amount of import or export duty corresponding to the customs debt and other charges in respect of all goods covered by or released against that declaration, whether or not that declaration is correct. If the guarantee has not been released, it may also be used, within the limits of the secured amount, for the recovery of amounts of import or export duty and other charges payable following post-release control of those goods. 5. Upon application by the person referred to in paragraph 3 of this Article, the customs authorities may, in accordance with Article 95(1), (2) and (3), authorise the provision of a comprehensive guarantee to cover the amount of import or export duty corresponding to the customs debt in respect of two or more operations, declarations or customs procedures. 6. The customs authorities shall monitor the guarantee. 7. No guarantee shall be required from States, regional and local government authorities or other bodies governed by public law, in respect of the activities in which they engage as public authorities. 8. No guarantee shall be required in any of the following situations: (a) goods carried on the Rhine, the Rhine waterways, the Danube or the Danube waterways; (b) goods carried by a fixed transport installation; (c) in specific cases where goods are placed under the temporary admission procedure; (d) goods placed under the Union transit procedure using the simplification referred to in point (e) of Article 233(4) and carried by sea or air between Union ports or between Union airports. 9. The customs authorities may waive the requirement for provision of a guarantee where the amount of import or export duty to be secured does not exceed the statistical value threshold for declarations laid down in Article 3(4) of Regulation (EC) No 471/2009 of the European Parliament and of the Council of 6 May 2009 on Community statistics relating to external trade with non-member countries (16). Article 90 Compulsory guarantee 1. Where it is compulsory for a guarantee to be provided, the customs authorities shall fix the amount of such guarantee at a level equal to the precise amount of import or export duty corresponding to the customs debt and of other charges where that amount can be established with certainty at the time when the guarantee is required. Where it is not possible to establish the precise amount, the guarantee shall be fixed at the maximum amount, as estimated by the customs authorities, of import or export duty corresponding to the customs debt and of other charges which have been or may be incurred. 2. Without prejudice to Article 95 where a comprehensive guarantee is provided for the amount of import or export duty corresponding to customs debts and other charges which vary in amount over time, the amount of such guarantee shall be set at a level enabling the amount of import or export duty corresponding to customs debts and other charges to be covered at all times. Article 91 Optional guarantee Where the provision of a guarantee is optional, such guarantee shall in any case be required by the customs authorities if they consider that the amount of import or export duty corresponding to a customs debt and other charges are not certain to be paid within the prescribed period. Its amount shall be fixed by those authorities so as not to exceed the level referred to in Article 90. Article 92 Provision of a guarantee 1. A guarantee may be provided in one of the following forms: (a) by a cash deposit or by any other means of payment recognised by the customs authorities as being equivalent to a cash deposit, made in euro or in the currency of the Member State in which the guarantee is required; (b) by an undertaking given by a guarantor; (c) by another form of guarantee which provides equivalent assurance that the amount of import or export duty corresponding to the customs debt and other charges will be paid. 2. A guarantee in the form of a cash deposit or any other equivalent means of payment shall be given in accordance with the provisions in force in the Member State in which the guarantee is required. Where a guarantee is given by making a cash deposit or any other equivalent means of payment, no interest thereon shall be payable by the customs authorities. Article 93 Choice of guarantee The person required to provide a guarantee may choose between the forms of guarantee laid down in Article 92(1). However, the customs authorities may refuse to accept the form of guarantee chosen where it is incompatible with the proper functioning of the customs procedure concerned. The customs authorities may require that the form of guarantee chosen be maintained for a specific period. Article 94 Guarantor 1. The guarantor referred to in point (b) of Article 92(1) shall be a third person established in the customs territory of the Union. The guarantor shall be approved by the customs authorities requiring the guarantee, unless the guarantor is a credit institution, financial institution or insurance company accredited in the Union in accordance with Union provisions in force. 2. The guarantor shall undertake in writing to pay the secured amount of import or export duty corresponding to a customs debt and other charges. 3. The customs authorities may refuse to approve the guarantor or the type of guarantee proposed where either does not appear certain to ensure payment within the prescribed period of the amount of import or export duty corresponding to the customs debt and of other charges. Article 95 Comprehensive guarantee 1. The authorisation referred to in Article 89(5) shall be granted only to persons who satisfy all of the following conditions: (a) they are established in the customs territory of the Union; (b) they fulfil the criteria laid down in point (a) of Article 39; (c) they are regular users of the customs procedures involved or operators of temporary storage facilities or they fulfil the criteria laid down in point (d) of Article 39. 2. Where a comprehensive guarantee is to be provided for customs debts and other charges which may be incurred, an economic operator may be authorised to use a comprehensive guarantee with a reduced amount or to have a guarantee waiver, provided that he or she fulfils the criteria laid down in points (b) and (c) of Article 39. 3. Where a comprehensive guarantee is to be provided for customs debts and other charges which have been incurred, an authorised economic operator for customs simplification shall, upon application, be authorised to use a comprehensive guarantee with a reduced amount. 4. The comprehensive guarantee with a reduced amount referred to in paragraph 3 shall be equivalent to the provision of a guarantee. Article 96 Temporary prohibitions relating to the use of comprehensive guarantees 1. In the context of special procedures or temporary storage, the Commission may decide to temporarily prohibit recourse to any of the following: (a) the comprehensive guarantee for a reduced amount or a guarantee waiver referred to in Article 95(2); (b) the comprehensive guarantee referred to in Article 95, in respect of goods which have been identified as being subject to large-scale fraud. 2. Where point (a) or point (b) of paragraph 1 of this Article applies, recourse to the comprehensive guarantee for a reduced amount or a guarantee waiver or recourse to the comprehensive guarantee referred to in Article 95 may be authorised where the person concerned fulfils either of the following conditions: (a) that person can show that no customs debt has arisen in respect of the goods in question in the course of operations which that person has undertaken in the two years preceding the decision referred to in paragraph 1; (b) where customs debts have arisen in the two years preceding the decision referred to in paragraph 1, the person concerned can show that those debts were fully paid by the debtor or debtors or the guarantor within the prescribed time-limit. To obtain authorisation to use a temporarily prohibited comprehensive guarantee, the person concerned must also fulfil the criteria laid down in points (b) and (c) of Article 39. Article 97 Additional or replacement guarantee Where the customs authorities establish that the guarantee provided does not ensure, or is no longer certain or sufficient to ensure, payment within the prescribed period of the amount of import or export duty corresponding to the customs debt and other charges, they shall require any of the persons referred to in Article 89(3) either to provide an additional guarantee or to replace the original guarantee with a new guarantee, according to his choice. Article 98 Release of the guarantee 1. The customs authorities shall release the guarantee immediately when the customs debt or liability for other charges is extinguished or can no longer arise. 2. Where the customs debt or liability for other charges has been extinguished in part, or may arise only in respect of part of the amount which has been secured, a corresponding part of the guarantee shall be released accordingly at the request of the person concerned, unless the amount involved does not justify such action. Article 99 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the specific cases, referred to in point (c) of Article 89(8), where no guarantee is required for goods placed under the temporary admission procedure; (b) the form of the guarantee, referred to in point (c) of Article 92(1), and the rules concerning the guarantor referred to in Article 94; (c) the conditions for the granting of an authorisation to use a comprehensive guarantee with a reduced amount or to have a guarantee waiver referred to in Article 95(2); (d) time-limits for the release of a guarantee. Article 100 Conferral of implementing powers 1. The Commission shall specify, by means of implementing acts, the procedural rules: (a) for determining the amount of the guarantee, including the reduced amount referred to in Article 95(2) and (3); (b) regarding the provision and the monitoring of the guarantee referred to in Article 89, the revocation and cancellation of the undertaking given by the guarantor referred to in Article 94, and the release of the guarantee referred to in Article 98; (c) regarding the temporary prohibitions referred to in Article 96. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt the measures referred to in Article 96 by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). On imperative grounds of urgency relating to such measures, duly justified by the need to rapidly enhance the protection of the financial interests of the Union and of its Member States, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 285(5). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. CHAPTER 3 Recovery, payment, repayment and remission of the amount of import or export duty Section 1 Determination of the amount of import or export duty, notification of the customs debt and entry in the accounts Article 101 Determination of the amount of import or export duty 1. The amount of import or export duty payable shall be determined by the customs authorities responsible for the place where the customs debt is incurred, or is deemed to have been incurred in accordance with Article 87, as soon as they have the necessary information. 2. Without prejudice to Article 48, the customs authorities may accept the amount of import or export duty payable determined by the declarant. 3. Where the amount of import or export duty payable does not result in a whole number, that amount may be rounded. Where the amount referred in the first subparagraph is expressed in euros, rounding may not be more than a rounding up or down to the nearest whole number. A Member State whose currency is not the euro may either apply mutatis mutandis the provisions of the second subparagraph or derogate from that subparagraph, provided that the rules applicable on rounding do not have a greater financial impact than the rule set out in the second subparagraph. Article 102 Notification of the customs debt 1. The customs debt shall be notified to the debtor in the form prescribed at the place where the customs debt is incurred, or is deemed to have been incurred in accordance with Article 87. The notification referred to in the first subparagraph shall not be made in any of the following cases: (a) where, pending a final determination of the amount of import or export duty, a provisional commercial policy measure taking the form of a duty has been imposed; (b) where the amount of import or export duty payable exceeds that determined on the basis of a decision made in accordance with Article 33; (c) where the original decision not to notify the customs debt or to notify it with an amount of import or export duty at a figure less than the amount of import or export duty payable was taken on the basis of general provisions invalidated at a later date by a court decision; (d) where the customs authorities are exempted under the customs legislation from notification of the customs debt. 2. Where the amount of import or export duty payable is equal to the amount entered in the customs declaration, release of the goods by the customs authorities shall be equivalent to notifying the debtor of the customs debt. 3. Where paragraph 2 does not apply, the customs debt shall be notified to the debtor by the customs authorities when they are in a position to determine the amount of import or export duty payable and take a decision thereon. However, where the notification of the customs debt would prejudice a criminal investigation, the customs authorities may defer that notification until such time as it no longer prejudices the criminal investigation. 4. Provided that payment has been guaranteed, the customs debt corresponding to the total amount of import or export duty relating to all the goods released to one and the same person during a period fixed by the customs authorities may be notified at the end of that period. The period fixed by the customs authorities shall not exceed 31 days. Article 103 Limitation of the customs debt 1. No customs debt shall be notified to the debtor after the expiry of a period of three years from the date on which the customs debt was incurred. 2. Where the customs debt is incurred as the result of an act which, at the time it was committed, was liable to give rise to criminal court proceedings, the three-year period laid down in paragraph 1 shall be extended to a period of a minimum of five years and a maximum of 10 years in accordance with national law. 3. The periods laid down in paragraphs 1 and 2 shall be suspended where: (a) an appeal is lodged in accordance with Article 44; such suspension shall apply from the date on which the appeal is lodged and shall last for the duration of the appeal proceedings; or (b) the customs authorities communicate to the debtor, in accordance with Article 22(6), the grounds on which they intend to notify the customs debt; such suspension shall apply from the date of that communication until the end of the period within which the debtor is given the opportunity to express his or her point of view. 4. Where a customs debt is reinstated pursuant to Article 116(7), the periods laid down in paragraphs 1 and 2 shall be considered as suspended from the date on which the application for repayment or remission was submitted in accordance with Article 121, until the date on which the decision on the repayment or remission was taken. Article 104 Entry in the accounts 1. The customs authorities referred to in Article 101 shall enter in their accounts, in accordance with the national legislation, the amount of import or export duty payable as determined in accordance with that Article. The first subparagraph shall not apply in cases referred to in the second subparagraph of Article 102(1). 2. The customs authorities need not enter in the accounts amounts of import or export duty which, pursuant to Article 103, correspond to a customs debt which could no longer be notified to the debtor. 3. Member States shall determine the practical procedures for the entry in the accounts of the amounts of import or export duty. Those procedures may differ according to whether, in view of the circumstances in which the customs debt was incurred, the customs authorities are satisfied that those amounts will be paid. Article 105 Time of entry in the accounts 1. Where a customs debt is incurred as a result of the acceptance of the customs declaration of goods for a customs procedure, other than temporary admission with partial relief from import duty, or of any other act having the same legal effect as such acceptance, the customs authorities shall enter the amount of import or export duty payable in the accounts within 14 days of the release of the goods. However, provided that payment has been guaranteed, the total amount of import or export duty relating to all the goods released to one and the same person during a period fixed by the customs authorities, which may not exceed 31 days, may be covered by a single entry in the accounts at the end of that period. Such entry in the accounts shall take place within 14 days of the expiry of the period concerned. 2. Where goods may be released subject to certain conditions which govern either the determination of the amount of import or export duty payable or its collection, entry in the accounts shall take place within 14 days of the day on which the amount of import or export duty payable is determined or the obligation to pay that duty is fixed. However, where the customs debt relates to a provisional commercial policy measure taking the form of a duty, the amount of import or export duty payable shall be entered in the accounts within two months of the date of publication in the Official Journal of the European Union of the Regulation establishing the definitive commercial policy measure. 3. Where a customs debt is incurred in circumstances not covered by paragraph 1, the amount of import or export duty payable shall be entered in the accounts within 14 days of the date on which the customs authorities are in a position to determine the amount of import or export duty in question and take a decision. 4. Paragraph 3 shall apply with regard to the amount of import or export duty to be recovered or which remains to be recovered where the amount of import or export duty payable has not been entered in the accounts in accordance with paragraphs 1, 2 and 3, or has been determined and entered in the accounts at a level lower than the amount payable. 5. The time-limits for entry in the accounts laid down in paragraphs 1, 2 and 3 shall not apply in unforeseeable circumstances or in cases of force majeure. 6. The entry in the accounts may be deferred in the case referred to in the second subparagraph of Article 102(3), until such time as the notification of the customs debt no longer prejudices a criminal investigation. Article 106 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the cases referred to in point (d) of Article 102(1) where the customs authorities are exempted from notification of the customs debt. Article 107 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, measures to ensure mutual assistance between the customs authorities in case of incurrence of a customs debt. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Payment of the amount of import or export duty Article 108 General time-limits for payment and suspension of the time-limit for payment 1. Amounts of import or export duty, corresponding to a customs debt notified in accordance with Article 102, shall be paid by the debtor within the period prescribed by the customs authorities. Without prejudice to Article 45(2), that period shall not exceed 10 days following notification to the debtor of the customs debt. In the case of aggregation of entries in the accounts under the conditions laid down in the second subparagraph of Article 105(1), it shall be so fixed as not to enable the debtor to obtain a longer period for payment than if he or she had been granted deferred payment in accordance with Article 110. The customs authorities may extend that period upon application by the debtor where the amount of import or export duty payable has been determined in the course of post-release control as referred to in Article 48. Without prejudice to Article 112(1), such extensions shall not exceed the time necessary for the debtor to take the appropriate steps to discharge his or her obligation. 2. If the debtor is entitled to any of the payment facilities laid down in Articles 110 to 112, payment shall be made within the period or periods specified in relation to those facilities. 3. The time-limit for payment of the amount of import or export duty corresponding to a customs debt shall be suspended in any of the following cases: (a) where an application for remission of duty is made in accordance with Article 121; (b) where goods are to be confiscated, destroyed or abandoned to the State; (c) where the customs debt was incurred pursuant to Article 79 and there is more than one debtor. Article 109 Payment 1. Payment shall be made in cash or by any other means with similar discharging effect, including by adjustment of a credit balance, in accordance with national legislation. 2. Payment may be made by a third person instead of the debtor. 3. The debtor may in any case pay all or part of the amount of import or export duty without awaiting expiry of the period he or she has been granted for payment. Article 110 Deferment of payment The customs authorities shall, upon application by the person concerned and upon provision of a guarantee, authorise deferment of payment of the duty payable in any of the following ways: (a) separately in respect of each amount of import or export duty entered in the accounts in accordance with the first subparagraph of Article 105(1), or Article 105(4); (b) globally in respect of all amounts of import or export duty entered in the accounts in accordance with the first subparagraph of Article 105(1) during a period fixed by the customs authorities and not exceeding 31 days; (c) globally in respect of all amounts of import or export duty forming a single entry in accordance with the second subparagraph of Article 105(1). Article 111 Periods for which payment is deferred 1. The period for which payment is deferred under Article 110 shall be 30 days. 2. Where payment is deferred in accordance with point (a) of Article 110, the period shall begin on the day following that on which the customs debt is notified to the debtor. 3. Where payment is deferred in accordance with point (b) of Article 110, the period shall begin on the day following that on which the aggregation period ends. It shall be reduced by the number of days corresponding to half the number of days covered by the aggregation period. 4. Where payment is deferred in accordance with point (c) of Article 110, the period shall begin on the day following the end of the period fixed for release of the goods in question. It shall be reduced by the number of days corresponding to half the number of days covered by the period concerned. 5. Where the number of days in the periods referred to in paragraphs 3 and 4 is an odd number, the number of days to be deducted from the 30-day period pursuant to those paragraphs shall be equal to half the next lowest even number. 6. Where the periods referred to in paragraphs 3 and 4 are weeks, Member States may provide that the amount of import or export duty in respect of which payment has been deferred is to be paid on the Friday of the fourth week following the week in question at the latest. If those periods are months, Member States may provide that the amount of import or export duty in respect of which payment has been deferred is to be paid by the 16th day of the month following the month in question. Article 112 Other payment facilities 1. The customs authorities may grant the debtor payment facilities other than deferred payment on condition that a guarantee is provided. 2. Where facilities are granted pursuant to paragraph 1, credit interest shall be charged on the amount of import or export duty. For a Member State whose currency is the euro, the rate of credit interest shall be equal to the interest rate as published in the Official Journal of the European Union, C series, which the European Central Bank applied to its main refinancing operations, on the first day of the month in which the due date fell, increased by one percentage point. For a Member State whose currency is not the euro, the rate of credit interest shall be equal to the rate applied on the first day of the month in question by the National Central Bank for its main refinancing operations, increased by one percentage point, or, for a Member State for which the National Central Bank rate is not available, the most equivalent rate applied on the first day of the month in question on the Member State's money market, increased by one percentage point. 3. The customs authorities may refrain from requiring a guarantee or from charging credit interest where it is established, on the basis of a documented assessment of the situation of the debtor, that this would create serious economic or social difficulties. 4. The customs authorities shall refrain from charging credit interest where the amount for each recovery action is less than EUR 10. Article 113 Enforcement of payment Where the amount of import or export duty payable has not been paid within the prescribed period, the customs authorities shall secure payment of that amount by all means available to them under the law of the Member State concerned. Article 114 Interest on arrears 1. Interest on arrears shall be charged on the amount of import or export duty from the date of expiry of the prescribed period until the date of payment. For a Member State whose currency is the euro, the rate of interest on arrears shall be equal to the interest rate as published in the Official Journal of the European Union, C series, which the European Central Bank applied to its main refinancing operations, on the first day of the month in which the due date fell, increased by two percentage points. For a Member State whose currency is not the euro, the rate of interest on arrears shall be equal to the rate applied on the first day of the month in question by the National Central Bank for its main refinancing operations, increased by two percentage points, or, for a Member State for which the National Central Bank rate is not available, the most equivalent rate applied on the first day of the month in question on the Member State's money market, increased by two percentage points. 2. Where the customs debt is incurred on the basis of Article 79 or 82, or where the notification of the customs debt results from a post-release control, interest on arrears shall be charged over and above the amount of import or export duty, from the date on which the customs debt was incurred until the date of its notification. The rate of interest on arrears shall be set in accordance with paragraph 1. 3. The customs authorities may refrain from charging interest on arrears where it is established, on the basis of a documented assessment of the situation of the debtor, that to charge it would create serious economic or social difficulties. 4. The customs authorities shall refrain from charging interest on arrears where the amount for each recovery action is less than EUR 10. Article 115 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the rules for the suspension of the time-limit for payment of the amount of import or export duty corresponding to a customs debt referred to in Article 108(3) and the period of suspension. Section 3 Repayment and remission Article 116 General provisions 1. Subject to the conditions laid down in this Section, amounts of import or export duty shall be repaid or remitted on any of the following grounds: (a) overcharged amounts of import or export duty; (b) defective goods or goods not complying with the terms of the contract; (c) error by the competent authorities; (d) equity. Where an amount of import or export duty has been paid and the corresponding customs declaration is invalidated in accordance with Article 174, that amount shall be repaid. 2. The customs authorities shall repay or remit the amount of import or export duty referred to in paragraph 1 where it is EUR 10 or more, except where the person concerned requests the repayment or remission of a lower amount. 3. Where the customs authorities consider that repayment or remission should be granted on the basis of Article 119 or 120, the Member State concerned shall transmit the file to the Commission for decision in any of the following cases: (a) where the customs authorities consider that the special circumstances are the result of the Commission failing in its obligations; (b) where the customs authorities consider that the Commission committed an error within the meaning of Article 119; (c) where the circumstances of the case relate to the findings of a Union investigation carried out under Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters (17), or under any other Union legislation or any agreement concluded by the Union with countries or groups of countries in which provision is made for carrying out such Union investigations; (d) where the amount for which the person concerned may be liable in respect of one or more import or export operations equals or exceeds EUR 500 000 as a result of an error or special circumstances. Notwithstanding the first subparagraph, files shall not be transmitted in either of the following situations: (a) where the Commission has already adopted a decision on a case involving comparable issues of fact and of law; (b) where the Commission is already considering a case involving comparable issues of fact and of law. 4. Subject to the rules of competence for a decision, where the customs authorities themselves discover within the periods referred to in Article 121(1) that an amount of import or export duty is repayable or remissible pursuant to Articles 117, 119 or 120 they shall repay or remit on their own initiative. 5. No repayment or remission shall be granted when the situation which led to the notification of the customs debt results from deception by the debtor. 6. Repayment shall not give rise to the payment of interest by the customs authorities concerned. However, interest shall be paid where a decision granting repayment is not implemented within three months of the date on which that decision was taken, unless the failure to meet the deadline was outside the control of the customs authorities. In such cases, the interest shall be paid from the date of expiry of the three-month period until the date of repayment. The rate of interest shall be established in accordance with Article 112. 7. Where the customs authorities have granted repayment or remission in error, the original customs debt shall be reinstated insofar as it is not time-barred under Article 103. In such cases, any interest paid under the second subparagraph of paragraph 5 shall be reimbursed. Article 117 Overcharged amounts of import or export duty 1. An amount of import or export duty shall be repaid or remitted insofar as the amount corresponding to the customs debt initially notified exceeds the amount payable, or the customs debt was notified to the debtor contrary to points (c) or (d) of Article 102(1). 2. Where the application for repayment or remission is based on the existence, at the time when the declaration for release for free circulation was accepted, of a reduced or zero rate of import duty on the goods under a tariff quota, a tariff ceiling or other favourable tariff measures, repayment or remission shall be granted provided that, at the time of lodging the application accompanied by the necessary documents, either of the following conditions are fulfilled: (a) in the case of a tariff quota, its volume has not been exhausted; (b) in other cases, the rate of duty normally due has not been re-established. Article 118 Defective goods or goods not complying with the terms of the contract 1. An amount of import duty shall be repaid or remitted if the notification of the customs debt relates to goods which have been rejected by the importer because, at the time of release, they were defective or did not comply with the terms of the contract on the basis of which they were imported. Defective goods shall be deemed to include goods damaged before their release. 2. Notwithstanding paragraph 3, repayment or remission shall be granted provided the goods have not been used, except for such initial use as may have been necessary to establish that they were defective or did not comply with the terms of the contract and provided they are taken out of the customs territory of the Union. 3. Repayment or remission shall not be granted where: (a) the goods, before being released for free circulation, were placed under a special procedure for testing, unless it is established that the fact that the goods were defective or did not comply with the terms of the contract could not normally have been detected in the course of such tests; (b) the defective nature of the goods was taken into consideration in drawing up the terms of the contract, in particular the price, before the goods were placed under a customs procedure involving the incurrence of a customs debt; or (c) the goods are sold by the applicant after it has been ascertained that they are defective or do not comply with the terms of the contract. 4. Instead of being taken out of the customs territory of the Union, and upon application by the person concerned, the customs authorities shall authorise that the goods be placed under the inward processing procedure, including for destruction, or the external transit, the customs warehousing or the free zone procedure. Article 119 Error by the competent authorities 1. In cases other than those referred to in the second subparagraph of Article 116(1) and in Articles 117, 118 and 120, an amount of import or export duty shall be repaid or remitted where, as a result of an error on the part of the competent authorities, the amount corresponding to the customs debt initially notified was lower than the amount payable, provided the following conditions are met: (a) the debtor could not reasonably have detected that error; and (b) the debtor was acting in good faith. 2. Where the conditions laid down in Article 117(2) are not fulfilled, repayment or remission shall be granted where failure to apply the reduced or zero rate of duty was as a result of an error on the part of the customs authorities and the customs declaration for release for free circulation contained all the particulars and was accompanied by all the documents necessary for application of the reduced or zero rate. 3. Where the preferential treatment of the goods is granted on the basis of a system of administrative cooperation involving the authorities of a country or territory outside the customs territory of the Union, the issue of a certificate by those authorities, should it prove to be incorrect, shall constitute an error which could not reasonably have been detected within the meaning of point (a) of paragraph 1. The issue of an incorrect certificate shall not, however, constitute an error where the certificate is based on an incorrect account of the facts provided by the exporter, except where it is evident that the issuing authorities were aware or should have been aware that the goods did not satisfy the conditions laid down for entitlement to the preferential treatment. The debtor shall be considered to be in good faith if he or she can demonstrate that, during the period of the trading operations concerned, he or she has taken due care to ensure that all the conditions for the preferential treatment have been fulfilled. The debtor may not rely on a plea of good faith if the Commission has published a notice in the Official Journal of the European Union stating that there are grounds for doubt concerning the proper application of the preferential arrangements by the beneficiary country or territory. Article 120 Equity 1. In cases other than those referred to in the second subparagraph of Article 116(1) and in Articles 117, 118 and 119 an amount of import or export duty shall be repaid or remitted in the interest of equity where a customs debt is incurred under special circumstances in which no deception or obvious negligence may be attributed to the debtor. 2. The special circumstances referred to in paragraph 1 shall be deemed to exist where it is clear from the circumstances of the case that the debtor is in an exceptional situation as compared with other operators engaged in the same business, and that, in the absence of such circumstances, he or she would not have suffered disadvantage by the collection of the amount of import or export duty. Article 121 Procedure for repayment and remission 1. Applications for repayment or remission in accordance with Article 116 shall be submitted to the customs authorities within the following periods: (a) in the case of overcharged, amounts of import or export duty, error by the competent authorities or equity, within three years of the date of notification of the customs debt; (b) in the case of defective goods or goods not complying with the terms of the contract, within one year of the date of notification of the customs debt; (c) in the case of invalidation of a customs declaration, within the period specified in the rules applicable to invalidation. The period specified in points (a) and (b) of the first subparagraph shall be extended where the applicant provides evidence that he or she was prevented from submitting an application within the prescribed period as a result of unforeseeable circumstances or force majeure. 2. Where the customs authorities are not in a position, on the basis of the grounds adduced, to grant repayment or remission of an amount of import or export duty, it is required to examine the merits of an application for repayment or remission in the light of the other grounds for repayment or remission referred to in Article 116. 3. Where an appeal has been lodged under Article 44 against the notification of the customs debt, the relevant period specified in the first subparagraph of paragraph 1 shall be suspended, from the date on which the appeal is lodged, for the duration of the appeal proceedings. 4. Where a customs authority grants repayment or remission in accordance with Articles 119 and 120, the Member State concerned shall inform the Commission thereof. Article 122 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, laying down the rules with which it has to comply when taking a decision referred to in Article 116(3) and in particular on the following: (a) the conditions for the acceptance of the file; (b) the time-limit to take a decision and the suspension of that time-limit; (c) the communication of the grounds on which the Commission intends to base its decision, before taking a decision which would adversely affect the person concerned; (d) the notification of the decision; (e) the consequences of a failure to take a decision or to notify such decision. Article 123 Conferral of implementing powers 1. The Commission shall specify, by means of implementing acts, the procedural rules for: (a) repayment and remission, as referred to in Article 116; (b) informing the Commission in accordance with Article 121(4) and the information to be provided. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt the decision referred to in Article 116(3) by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 285(2). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. CHAPTER 4 Extinguishment of a customs debt Article 124 Extinguishment 1. Without prejudice to the provisions in force relating to non-recovery of the amount of import or export duty corresponding to a customs debt in the event of the judicially established insolvency of the debtor, a customs debt on import or export shall be extinguished in any of the following ways: (a) where the debtor can no longer be notified of the customs debt, in accordance with Article 103; (b) by payment of the amount of import or export duty; (c) subject to paragraph 5, by remission of the amount of import or export duty; (d) where, in respect of goods declared for a customs procedure entailing the obligation to pay import or export duty, the customs declaration is invalidated; (e) where goods liable to import or export duty are confiscated or seized and simultaneously or subsequently confiscated; (f) where goods liable to import or export duty are destroyed under customs supervision or abandoned to the State; (g) where the disappearance of the goods or the non-fulfilment of obligations arising from the customs legislation results from the total destruction or irretrievable loss of those goods as a result of the actual nature of the goods or unforeseeable circumstances or force majeure, or as a consequence of instruction by the customs authorities; for the purpose of this point, goods shall be considered as irretrievably lost when they have been rendered unusable by any person; (h) where the customs debt was incurred pursuant to Article 79 or 82 and where the following conditions are fulfilled: (i) the failure which led to the incurrence of a customs debt had no significant effect on the correct operation of the customs procedure concerned and did not constitute an attempt at deception; (ii) all of the formalities necessary to regularise the situation of the goods are subsequently carried out; (i) where goods released for free circulation duty-free, or at a reduced rate of import duty by virtue of their end-use, have been exported with the permission of the customs authorities; (j) where it was incurred pursuant to Article 78 and where the formalities carried out in order to enable the preferential tariff treatment referred to in that Article to be granted are cancelled; (k) where, subject to paragraph 6, the customs debt was incurred pursuant to Article 79 and evidence is provided to the satisfaction of the customs authorities that the goods have not been used or consumed and have been taken out of the customs territory of the Union. 2. In the cases referred to in point (e) of paragraph 1, the customs debt shall, nevertheless, for the purposes of penalties applicable to customs offences, be deemed not to have been extinguished where, under the law of a Member State, import or export duty or the existence of a customs debt provide the basis for determining penalties. 3. Where, in accordance with point (g) of paragraph 1, a customs debt is extinguished in respect of goods released for free circulation duty-free or at a reduced rate of import duty on account of their end-use, any scrap or waste resulting from their destruction shall be deemed to be non-Union goods. 4. The provisions in force pertaining to standard rates for irretrievable loss due to the nature of goods shall apply where the person concerned fails to show that the real loss exceeds that calculated by applying the standard rate for the goods in question. 5. Where several persons are liable for payment of the amount of import or export duty corresponding to the customs debt and remission is granted, the customs debt shall be extinguished only in respect of the person or persons to whom the remission is granted. 6. In the case referred to in point (k) of paragraph 1, the customs debt shall not be extinguished in respect of any person or persons who attempted deception. 7. Where the customs debt was incurred pursuant to Article 79, it shall be extinguished with regard to the person whose behaviour did not involve any attempt at deception and who contributed to the fight against fraud. Article 125 Application of penalties Where the customs debt is extinguished on the basis of point (h) of Article 124(1), Member States shall not be precluded from the application of penalties for failure to comply with the customs legislation. Article 126 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the list of failures with no significant effect on the correct operation of the customs procedure concerned and to supplement point (i) of point (h) of Article 124(1). TITLE IV GOODS BROUGHT INTO THE CUSTOMS TERRITORY OF THE UNION CHAPTER 1 Entry summary declaration Article 127 Lodging of an entry summary declaration 1. Goods brought into the customs territory of the Union shall be covered by an entry summary declaration. 2. The obligation referred to in paragraph 1 shall be waived: (a) for means of transport and the goods carried thereon only passing through the territorial waters or the airspace of the customs territory of the Union without a stop within that territory; and (b) in other cases, where duly justified by the type of goods or traffic, or where required by international agreements. 3. The entry summary declaration shall be lodged at the customs office of first entry within a specific time-limit, before the goods are brought into the customs territory of the Union. Customs authorities may allow the entry summary declaration to be lodged at another customs office, provided that the latter immediately communicates or makes available electronically the necessary particulars to the customs office of first entry. 4. The entry summary declaration shall be lodged by the carrier. Notwithstanding the obligations of the carrier, the entry summary declaration may be lodged instead by one of the following persons: (a) the importer or consignee or other person in whose name or on whose behalf the carrier acts; (b) any person who is able to present the goods in question or have them presented at the customs office of entry. 5. The entry summary declaration shall contain the particulars necessary for risk analysis for security and safety purposes. 6. In specific cases, where all the particulars referred to in paragraph 5 cannot be obtained from the persons referred to in paragraph 4, other persons holding those particulars and the appropriate rights to provide them may be required to provide those particulars. 7. Customs authorities may accept that commercial, port or transport information systems are used for the lodging of an entry summary declaration provided such systems contain the necessary particulars for such declaration and those particulars are available within a specific time-limit, before the goods are brought into the customs territory of the Union. 8. Customs authorities may accept, instead of the lodging of the entry summary declaration, the lodging of a notification and access to the particulars of an entry summary declaration in the economic operator's computer system. Article 128 Risk analysis The customs office referred to in Article 127(3) shall, within a specific time-limit, ensure that a risk analysis is carried out, primarily for security and safety purposes, on the basis of the entry summary declaration referred to in Article 127(1) or the particulars referred to in Article 127(8) and shall take the necessary measures based on the results of that risk analysis. Article 129 Amendment and invalidation of an entry summary declaration 1. The declarant may, upon application, be permitted to amend one or more particulars of the entry summary declaration after it has been lodged. No amendment shall be possible after any of the following: (a) the customs authorities have informed the person who lodged the entry summary declaration that they intend to examine the goods; (b) the customs authorities have established that the particulars of the entry summary declaration are incorrect; (c) the goods have already been presented to customs. 2. When the goods for which an entry summary declaration has been lodged are not brought into the customs territory of the Union, the customs authorities shall invalidate that declaration in either of the following cases: (a) upon application by the declarant; (b) within 200 days after the lodging of the declaration. Article 130 Declarations lodged instead of an entry summary declaration 1. The customs office referred to in Article 127(3) may waive the lodging of an entry summary declaration in respect of goods for which, prior to the expiry of the time-limit for lodging that declaration, a customs declaration is lodged. In that case, the customs declaration shall contain at least the particulars necessary for the entry summary declaration. Until such time as the customs declaration is accepted in accordance with Article 172, it shall have the status of an entry summary declaration. 2. The customs office referred to in Article 127(3) may waive the lodging of an entry summary declaration in respect of goods for which, prior to the expiry of the time-limit for lodging that declaration, a temporary storage declaration is lodged. That declaration shall contain at least the particulars necessary for the entry summary declaration. Until such time as the goods declared are presented to customs in accordance with Article 139, the temporary storage declaration shall have the status of an entry summary declaration. Article 131 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the cases where the obligation to lodge an entry summary declaration is waived, in accordance with point (c) of Article 127(2); (b) the specific time-limit referred to in Article 127(3) and (7), within which the entry summary declaration is to be lodged before the goods are brought into the customs territory of the Union, taking into account the type of goods or traffic; (c) the cases referred to in Article 127(6) and the other persons who may be required to provide particulars of the entry summary declaration in those cases. Article 132 Conferral of implementing powers The Commission shall specify, by means of implementing acts: (a) the procedural rules for lodging the entry summary declaration referred to in Article 127; (b) the procedural rules and the provision of particulars of the entry summary declaration by the other persons referred to in Article 127(6); (c) the time-limit within which a risk analysis is to be carried out and the necessary measures to be taken, in accordance with Article 128; (d) the procedural rules for amending the entry summary declaration, in accordance with Article 129(1); (e) the procedural rules for invalidating the entry summary declaration in accordance with Article 129(2), taking into account the proper management of the entry of the goods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 2 Arrival of goods Section 1 Entry of goods into the customs territory of the Union Article 133 Notification of arrival of a sea-going vessel or of an aircraft 1. The operator of a sea-going vessel or of an aircraft entering the customs territory of the Union shall notify the arrival to the customs office of first entry upon arrival of the means of transport. Where information on arrival of a sea-going vessel or of an aircraft is available to the customs authorities they may waive the notification referred to in the first subparagraph. 2. Customs authorities may accept that port or airport systems or other available methods of information be used to notify the arrival of the means of transport. Article 134 Customs supervision 1. Goods brought into the customs territory of the Union shall, from the time of their entry, be subject to customs supervision and may be subject to customs controls. Where applicable, they shall be subject to such prohibitions and restrictions as are justified on grounds of, inter alia, public morality, public policy or public security, the protection of the health and life of humans, animals or plants, the protection of the environment, the protection of national treasures possessing artistic, historic or archaeological value and the protection of industrial or commercial property, including controls on drug precursors, goods infringing certain intellectual property rights and cash, as well as to the implementation of fishery conservation and management measures and of commercial policy measures. They shall remain under such supervision for as long as is necessary to determine their customs status and shall not be removed therefrom without the permission of the customs authorities. Without prejudice to Article 254, Union goods shall not be subject to customs supervision once their customs status is established. Non-Union goods shall remain under customs supervision until their customs status is changed, or they are taken out of the customs territory of the Union or destroyed. 2. The holder of goods under customs supervision may, with the permission of the customs authorities, at any time examine the goods or take samples, in particular in order to determine their tariff classification, customs value or customs status. Article 135 Conveyance to the appropriate place 1. The person who brings goods into the customs territory of the Union shall convey them without delay, by the route specified by the customs authorities and in accordance with their instructions, if any, to the customs office designated by the customs authorities, or to any other place designated or approved by those authorities, or into a free zone. 2. Goods brought into a free zone shall be brought into that free zone directly, either by sea or air or, if by land, without passing through another part of the customs territory of the Union, where the free zone adjoins the land frontier between a Member State and a third country. 3. Any person who assumes responsibility for the carriage of goods after they have been brought into the customs territory of the Union shall become responsible for compliance with the obligations laid down in paragraphs 1 and 2. 4. Goods which, although still outside the customs territory of the Union, may be subject to customs controls by the customs authority of a Member State as a result of an agreement concluded with the relevant country or territory outside the customs territory of the Union, shall be treated in the same way as goods brought into the customs territory of the Union. 5. Paragraphs 1 and 2 shall not preclude application of special rules with respect to goods transported within frontier zones or in pipelines and wires as well as for traffic of negligible economic importance such as letters, postcards and printed matter and their electronic equivalents held on other media or to goods carried by travellers, provided that customs supervision and customs control possibilities are not thereby jeopardised. 6. Paragraph 1 shall not apply to means of transport and goods carried thereon only passing through the territorial waters or the airspace of the customs territory of the Union without a stop within that territory. Article 136 Intra-Union air and sea services Articles 127 to 130 and 133, Article 135(1) and Articles 137, 139 to 141, and 144 to 149 shall not apply to non-Union goods and goods referred to in Article 155, which have temporarily left the customs territory of the Union while moving between two points in that territory by sea or air, provided they have been carried by direct route without a stop outside the customs territory of the Union. Article 137 Conveyance under special circumstances 1. Where, by reason of unforeseeable circumstances or force majeure, the obligation laid down in Article 135(1) cannot be complied with, the person bound by that obligation or any other person acting on that person's behalf shall inform the customs authorities of the situation without delay. Where the unforeseeable circumstances or force majeure do not result in total loss of the goods, the customs authorities shall also be informed of their precise location. 2. Where, by reason of unforeseeable circumstances or force majeure, a vessel or aircraft covered by Article 135(6) is forced to put into port or to land temporarily in the customs territory of the Union and the obligation laid down in Article 135(1) cannot be complied with, the person who brought the vessel or aircraft into the customs territory of the Union, or any other person acting on that person's behalf, shall inform the customs authorities of the situation without delay. 3. The customs authorities shall determine the measures to be taken in order to permit customs supervision of the goods referred to in paragraph 1, or of the vessel or aircraft and any goods thereon in the circumstances specified in paragraph 2, and to ensure, where appropriate, that they are subsequently conveyed to a customs office or other place designated or approved by the authorities. Article 138 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on: (a) the notification of arrival referred to in Article 133; (b) the conveyance of goods referred to in Article 135(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Presentation, unloading and examination of goods Article 139 Presentation of goods to customs 1. Goods brought into the customs territory of the Union shall be presented to customs immediately upon their arrival at the designated customs office or any other place designated or approved by the customs authorities or in the free zone by one of the following persons: (a) the person who brought the goods into the customs territory of the Union; (b) the person in whose name or on whose behalf the person who brought the goods into that territory acts; (c) the person who assumed responsibility for carriage of the goods after they were brought into the customs territory of the Union. 2. Goods which are brought into the customs territory of the Union by sea or air and which remain on board the same means of transport for carriage, shall be presented to customs only at the port or airport where they are unloaded or transhipped. However, goods brought into the customs territory of the Union which are unloaded and reloaded onto the same means of transport during its voyage in order to enable the unloading or loading of other goods, shall not be presented to customs at that port or airport. 3. Notwithstanding the obligations of the person described in paragraph 1, presentation of the goods may be effected instead by one of the following persons: (a) any person who immediately places the goods under a customs procedure; (b) the holder of an authorisation for the operation of storage facilities or any person who carries out an activity in a free zone. 4. The person presenting the goods shall make a reference to the entry summary declaration or, in the cases referred to in Article 130, the customs declaration or temporary storage declaration which has been lodged in respect of the goods, except where the obligation to lodge an entry summary declaration is waived. 5. Where non-Union goods presented to customs are not covered by an entry summary declaration, and except where the obligation to lodge such declaration is waived, one of the persons referred to in Article 127(4) shall, without prejudice to Article 127(6), lodge immediately such declaration or shall instead lodge a customs declaration or temporary storage declaration. 6. Paragraph 1 shall not preclude application of special rules with respect to goods transported within frontier zones or in pipelines and wires as well as for traffic of negligible economic importance such as letters, postcards and printed matter and their electronic equivalents held on other media or to goods carried by travellers, provided that customs supervision and customs control possibilities are not thereby jeopardised. 7. Goods presented to customs shall not be removed from the place where they have been presented without the permission of the customs authorities. Article 140 Unloading and examination of goods 1. Goods shall be unloaded or trans-shipped from the means of transport carrying them solely with the authorisation of the customs authorities in places designated or approved by those authorities. However, such authorisation shall not be required in the event of an imminent danger necessitating the immediate unloading of all or part of the goods. In that case, the customs authorities shall immediately be informed accordingly. 2. The customs authorities may at any time require goods to be unloaded and unpacked for the purpose of examining them, taking samples or examining the means of transport carrying them. Article 141 Goods moved under transit 1. Article 135(2) to (6) and Articles 139, 140 and 144 to 149 shall not apply when goods already under a transit procedure are brought into the customs territory of the Union. 2. Articles 140 and 144 to 149 shall apply to non-Union goods moved under a transit procedure, once such goods have been presented to the customs office of destination in the customs territory of the Union in accordance with the rules governing the transit procedure. Article 142 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine the conditions for approving the places referred to in Article 139(1). Article 143 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules regarding the presentation of goods to customs referred to in Article 139. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 3 Temporary storage of goods Article 144 Goods in temporary storage Non-Union goods shall be in temporary storage from the moment they are presented to customs. Article 145 Temporary storage declaration 1. Non-Union goods presented to customs shall be covered by a temporary storage declaration containing all the particulars necessary for the application of the provisions governing temporary storage. 2. Documents related to goods in temporary storage shall be provided to the customs authorities where Union legislation so requires or where necessary for customs controls. 3. The temporary storage declaration shall be lodged by one of the persons referred to in Article 139(1) or (2) at the latest at the time of the presentation of the goods to customs. 4. The temporary storage declaration shall, unless the obligation to lodge an entry summary declaration is waived, include a reference to any entry summary declaration lodged for the goods presented to customs, except where they have already been in temporary storage or have been placed under a customs procedure and have not left the customs territory of the Union. 5. Customs authorities may accept that the temporary storage declaration also takes one of the following forms: (a) a reference to any entry summary declaration lodged for the goods concerned, supplemented by the particulars of a temporary storage declaration; (b) a manifest or another transport document, provided that it contains the particulars of a temporary storage declaration, including a reference to any entry summary declaration for the goods concerned. 6. Customs authorities may accept that commercial, port or transport information systems are used to lodge a temporary storage declaration provided that they contain the necessary particulars for such declaration and these particulars are available in accordance with paragraph 3. 7. Articles 188 to 193 shall apply to the temporary storage declaration. 8. The temporary storage declaration may be used also for the purpose of: (a) the notification of arrival referred to in Article 133; or (b) the presentation of the goods to customs referred to in Article 139, insofar as it fulfils the conditions laid down in those provisions. 9. A temporary storage declaration shall not be required where, at the latest at the time of the presentation of the goods to customs, their customs status as Union goods is determined in accordance with Articles 153 to 156. 10. The temporary storage declaration shall be kept by, or be accessible to, the customs authorities for the purpose of verifying that the goods to which it relates are subsequently placed under a customs procedure or re-exported in accordance with Article 149. 11. For the purpose of paragraphs 1 to 10, where non-Union goods moved under a transit procedure are presented to customs at an office of destination within the customs territory of the Union, the particulars for the transit operation concerned shall be deemed to be the temporary storage declaration, provided they meet the requirements for that purpose. However, the holder of the goods may lodge a temporary storage declaration after the end of the transit procedure. Article 146 Amendment and invalidation of a temporary storage declaration 1. The declarant shall, upon application, be permitted to amend one or more particulars of the temporary storage declaration after it has been lodged. The amendment shall not render the declaration applicable to goods other than those which it originally covered. No amendment shall be possible after any of the following: (a) the customs authorities have informed the person who lodged the declaration that they intend to examine the goods; (b) the customs authorities have established that particulars of the declaration are incorrect. 2. Where the goods for which a temporary storage declaration has been lodged are not presented to customs, the customs authorities shall invalidate that declaration in either of the following cases: (a) upon application by the declarant; (b) within 30 days after the lodging of the declaration. Article 147 Conditions and responsibilities for the temporary storage of goods 1. Goods in temporary storage shall be stored only in temporary storage facilities in accordance with Article 148 or, where justified, in other places designated or approved by the customs authorities. 2. Without prejudice to Article 134(2), goods in temporary storage shall be subject only to such forms of handling as are designed to ensure their preservation in an unaltered state without modifying their appearance or technical characteristics. 3. The holder of the authorisation referred to in Article 148 or the person storing the goods in the cases where the goods are stored in other places designated or approved by the customs authorities, shall be responsible for all of the following: (a) ensuring that goods in temporary storage are not removed from customs supervision; (b) fulfilling the obligations arising from the storage of goods in temporary storage. 4. Where, for any reason, goods cannot be maintained in temporary storage, the customs authorities shall without delay take all measures necessary to regularise the situation of the goods in accordance with Articles 197, 198 and 199. Article 148 Authorisation for the operation of temporary storage facilities 1. An authorisation from the customs authorities shall be required for the operation of temporary storage facilities. Such authorisation shall not be required where the operator of the temporary storage facility is the customs authority itself. The conditions under which the operation of temporary storage facilities is permitted shall be set out in the authorisation. 2. The authorisation referred to in paragraph 1 shall be granted only to persons who satisfy all of the following conditions: (a) they are established in the customs territory of the Union; (b) they provide the necessary assurance of the proper conduct of the operations; an authorised economic operator for customs simplifications shall be deemed to fulfil that condition insofar as the operation of temporary storage facilities is taken into account in the authorisation referred to in point (a) of Article 38(2); (c) they provide a guarantee in accordance with Article 89. Where a comprehensive guarantee is provided, compliance with the obligations attached to that guarantee shall be monitored by appropriate audit. 3. The authorisation referred to in paragraph 1 shall be granted only where the customs authorities are able to exercise customs supervision without having to introduce administrative arrangements which are disproportionate to the economic needs involved. 4. The holder of the authorisation shall keep appropriate records in a form approved by the customs authorities. The records shall contain the information and the particulars which enable the customs authorities to supervise the operation of the temporary storage facilities, in particular with regard to the identification of the goods stored, their customs status and their movements. An authorised economic operator for customs simplifications shall be deemed to comply with the obligation referred to in the first and second subparagraphs, insofar as his or her records are appropriate for the purpose of the operation of temporary storage. 5. The customs authorities may authorise the holder of the authorisation to move goods in temporary storage between different temporary storage facilities under the condition that such movements would not increase the risk of fraud, as follows: (a) such movement takes place under the responsibility of one customs authority; (b) such movement is covered by only one authorisation, issued to an authorised economic operator for customs simplifications; or (c) in other cases of movement. 6. The customs authorities may, where an economic need exists and customs supervision will not be adversely affected, authorise the storage of Union goods in a temporary storage facility. Those goods shall not be regarded as goods in temporary storage. Article 149 End of temporary storage Non-Union goods in temporary storage shall be placed under a customs procedure or re-exported within 90 days. Article 150 Choice of a customs procedure Except where otherwise provided, the declarant shall be free to choose the customs procedure under which to place the goods, under the conditions for that procedure, irrespective of their nature or quantity, or their country of origin, consignment or destination. Article 151 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the conditions for approving the places referred to in Article 147(1); (b) the conditions for granting the authorisation for the operation of temporary storage facilities, referred to in Article 148; (c) the cases of movement referred to in point (c) of Article 148(5). Article 152 Conferral of implementing power The Commission shall specify, by means of implementing acts, the procedural rules for: (a) lodging the temporary storage declaration referred to in Article 145; (b) amending the temporary storage declaration, in accordance with Article 146(1); (c) invalidating the temporary storage declaration, in accordance with Article 146(2); (d) the movement of goods in temporary storage referred to in Article 148(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). TITLE V GENERAL RULES ON CUSTOMS STATUS, PLACING GOODS UNDER A CUSTOMS PROCEDURE, VERIFICATION, RELEASE AND DISPOSAL OF GOODS CHAPTER 1 Customs status of goods Article 153 Presumption of customs status of Union goods 1. All goods in the customs territory of the Union shall be presumed to have the customs status of Union goods, unless it is established that they are not Union goods. 2. In specific cases, where the presumption laid down in paragraph 1 does not apply, the customs status of Union goods shall need to be proven. 3. In specific cases, goods wholly obtained in the customs territory of the Union do not have the customs status of Union goods if they are obtained from goods in temporary storage or placed under the external transit procedure, a storage procedure, the temporary admission procedure or the inward processing procedure. Article 154 Loss of customs status of Union goods Union goods shall become non-Union goods in the following cases: (a) where they are taken out of the customs territory of the Union, insofar as the rules on internal transit do not apply; (b) where they have been placed under the external transit procedure, a storage procedure or the inward processing procedure, insofar as the customs legislation so allows; (c) where they have been placed under the end-use procedure and are either subsequently abandoned to the State, or are destroyed and waste remains; (d) where the declaration for release for free circulation is invalidated after release of the goods. Article 155 Union goods leaving the customs territory of the Union temporarily 1. In the cases referred to in points (b) to (f) of Article 227(2), goods shall keep their customs status as Union goods only if that status is established under certain conditions and by means laid down in the customs legislation. 2. In specific cases, Union goods may move, without being subject to a customs procedure, from one point to another within the customs territory of the Union and temporarily out of that territory without alteration of their customs status. Article 156 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the cases where the presumption laid down in Article 153(1) does not apply; (b) the conditions for granting facilitation in the establishment of the proof of customs status of Union goods; (c) the cases where the goods referred to in Article 153(3) do not have the customs status of Union goods; (d) the cases where the customs status of goods referred to in Article 155(2) is not altered. Article 157 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the provision and verification of the proof of the customs status of Union goods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 2 Placing goods under a customs procedure Section 1 General provisions Article 158 Customs declaration of goods and customs supervision of Union goods 1. All goods intended to be placed under a customs procedure, except for the free zone procedure, shall be covered by a customs declaration appropriate for the particular procedure. 2. In specific cases, other than those referred to in Article 6(2), a customs declaration may be lodged using means other than electronic data-processing techniques. 3. Union goods declared for export, internal Union transit or outward processing shall be subject to customs supervision from the time of acceptance of the declaration referred to in paragraph 1 until such time as they are taken out of the customs territory of the Union or are abandoned to the State or destroyed or the customs declaration is invalidated. Article 159 Competent customs offices 1. Except where Union legislation provides otherwise, Member States shall determine the location and competence of the various customs offices situated in their territory. 2. Member States shall ensure that official opening hours are fixed for those offices that are reasonable and appropriate, taking into account the nature of the traffic and of the goods and the customs procedures under which they are to be placed, so that the flow of international traffic is neither hindered nor distorted. 3. Except where otherwise provided, the competent customs office for placing the goods under a customs procedure shall be the customs office responsible for the place where the goods are presented to customs. Article 160 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the cases where a customs declaration may be lodged using means other than electronic data-processing techniques in accordance with Article 158(2). Article 161 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) determining the competent customs offices other than the one referred to in Article 159(3), including customs offices of entry and customs offices of exit; (b) lodging the customs declaration in the cases referred to in Article 158(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Standard customs declarations Article 162 Content of a standard customs declaration Standard customs declarations shall contain all the particulars necessary for application of the provisions governing the customs procedure for which the goods are declared. Article 163 Supporting documents 1. The supporting documents required for the application of the provisions governing the customs procedure for which the goods are declared shall be in the declarant's possession and at the disposal of the customs authorities at the time when the customs declaration is lodged. 2. Supporting documents shall be provided to the customs authorities where Union legislation so requires or where necessary for customs controls. 3. In specific cases, economic operators may draw up the supporting documents provided they are authorised to do so by the customs authorities. Article 164 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, laying down the rules for granting the authorisation referred to in Article 163(3). Article 165 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules: (a) for lodging the standard customs declaration referred to in Article 162; (b) on the making available of the supporting documents referred to in Article 163(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 3 Simplified customs declarations Article 166 Simplified declaration 1. The customs authorities may accept that a person has goods placed under a customs procedure on the basis of a simplified declaration which may omit certain of the particulars referred to in Article 162 or the supporting documents referred to in Article 163. 2. The regular use of a simplified declaration referred to in paragraph 1 shall be subject to an authorisation from the customs authorities. Article 167 Supplementary declaration 1. In the case of a simplified declaration pursuant to Article 166 or of an entry in the declarant's records pursuant to Article 182, the declarant shall lodge a supplementary declaration containing the particulars necessary for the customs procedure concerned at the competent customs office within a specific time-limit. In the case of a simplified declaration pursuant to Article 166, the necessary supporting documents shall be in the declarant's possession and at the disposal of the customs authorities within a specific time-limit. The supplementary declaration may be of a general, periodic or recapitulative nature. 2. The obligation to lodge a supplementary declaration shall be waived in the following cases: (a) where the goods are placed under a customs warehousing procedure; (b) in other specific cases. 3. The customs authorities may waive the requirement to lodge a supplementary declaration where the following conditions apply: (a) the simplified declaration concerns goods the value and quantity of which is below the statistical threshold; (b) the simplified declaration already contains all the information needed for the customs procedure concerned; and (c) the simplified declaration is not made by entry in the declarant's records. 4. The simplified declaration referred to in Article 166 or the entry in the declarant's records referred to in Article 182, and the supplementary declaration shall be deemed to constitute a single, indivisible instrument taking effect, respectively, on the date on which the simplified declaration is accepted in accordance with Article 172 and on the date on which the goods are entered in the declarant's records. 5. The place where the supplementary declaration is to be lodged shall be deemed, for the purposes of Article 87, to be the place where the customs declaration has been lodged. Article 168 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the conditions for granting the authorisation referred to in Article 166(2); (b) the specific time-limit referred to in the first subparagraph of Article 167(1) within which the supplementary declaration is to be lodged; (c) the specific time-limit referred to in the second subparagraph of Article 167(1) within which supporting documents are to be in the possession of the declarant; (d) the specific cases where the obligation to lodge a supplementary declaration is waived in accordance with point (b) of Article 167(2). Article 169 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for lodging: (a) the simplified declaration referred to in Article 166; (b) the supplementary declaration referred to in Article 167. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 4 Provisions applying to all customs declarations Article 170 Lodging a customs declaration 1. Without prejudice to Article 167(1), a customs declaration may be lodged by any person who is able to provide all of the information which is required for the application of the provisions governing the customs procedure in respect of which the goods are declared. That person shall also be able to present the goods in question or to have them presented to customs. However, where acceptance of a customs declaration imposes particular obligations on a specific person, that declaration shall be lodged by that person or by his or her representative. 2. The declarant shall be established in the customs territory of the Union. 3. By way of derogation from paragraph 2, the following declarants shall not be required to be established in the customs territory of the Union: (a) persons who lodge a customs declaration for transit or temporary admission; (b) persons, who occasionally lodge a customs declaration, including for end-use or inward processing, provided that the customs authorities consider this to be justified; (c) persons who are established in a country the territory of which is adjacent to the customs territory of the Union, and who present the goods to which the customs declaration refers at a Union border customs office adjacent to that country, provided that the country in which the persons are established grants reciprocal benefits to persons established in the customs territory of the Union. 4. Customs declarations shall be authenticated. Article 171 Lodging a customs declaration prior to the presentation of the goods A customs declaration may be lodged prior to the expected presentation of the goods to customs. If the goods are not presented within 30 days of lodging of the customs declaration, the customs declaration shall be deemed not to have been lodged. Article 172 Acceptance of a customs declaration 1. Customs declarations which comply with the conditions laid down in this Chapter shall be accepted by the customs authorities immediately, provided that the goods to which they refer have been presented to customs. 2. The date of acceptance of the customs declaration by the customs authorities shall, except where otherwise provided, be the date to be used for the application of the provisions governing the customs procedure for which the goods are declared and for all other import or export formalities. Article 173 Amendment of a customs declaration 1. The declarant shall, upon application, be permitted to amend one or more of the particulars of the customs declaration after that declaration has been accepted by customs. The amendment shall not render the customs declaration applicable to goods other than those which it originally covered. 2. No such amendment shall be permitted where it is applied for after any of the following events: (a) the customs authorities have informed the declarant that they intend to examine the goods; (b) the customs authorities have established that the particulars of the customs declaration are incorrect; (c) the customs authorities have released the goods. 3. Upon application by the declarant, within three years of the date of acceptance of the customs declaration, the amendment of the customs declaration may be permitted after release of the goods in order for the declarant to comply with his or her obligations relating to the placing of the goods under the customs procedure concerned. Article 174 Invalidation of a customs declaration 1. The customs authorities shall, upon application by the declarant, invalidate a customs declaration already accepted in either of the following cases: (a) where they are satisfied that the goods are immediately to be placed under another customs procedure; (b) where they are satisfied that, as a result of special circumstances, the placing of the goods under the customs procedure for which they were declared is no longer justified. However, where the customs authorities have informed the declarant of their intention to examine the goods, an application for invalidation of the customs declaration shall not be accepted before the examination has taken place. 2. The customs declaration shall not be invalidated after the goods have been released unless where otherwise provided. Article 175 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the cases where the customs declaration is invalidated after the release of the goods, as referred to in Article 174(2). Article 176 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) lodging a customs declaration in accordance with Article 171; (b) accepting a customs declaration as referred to in Article 172, including the application of those rules in the cases referred to in Article 179; (c) amending the customs declaration after the release of the goods in accordance with Article 173(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 5 Other simplifications Article 177 Simplification of the drawing-up of customs declarations for goods falling under different tariff subheadings 1. Where a consignment is made up of goods falling within different tariff subheadings, and dealing with each of those goods in accordance with its tariff subheading for the purpose of drawing-up the customs declaration would entail a burden of work and expense disproportionate to the import or export duty chargeable, the customs authorities may, upon application by the declarant, agree that import or export duty be charged on the whole consignment on the basis of the tariff subheading of the goods which are subject to the highest rate of import or export duty. 2. Customs authorities shall refuse the use of the simplification referred to in paragraph 1 to goods subject to prohibitions or restrictions or excise duty where the correct classification is necessary to apply the measure. Article 178 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, measures for the determination of the tariff subheading for the application of Article 177(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 179 Centralised clearance 1. The customs authorities may, upon application, authorise a person to lodge at a customs office responsible for the place where such person is established, a customs declaration for goods which are presented to customs at another customs office. The requirement for the authorisation referred to in the first subparagraph may be waived where the customs declaration is lodged and the goods presented to customs offices under the responsibility of one customs authority. 2. The applicant for the authorisation referred to in paragraph 1 shall be an authorised economic operator for customs simplifications. 3. The customs office at which the customs declaration is lodged shall: (a) supervise the placing of the goods under the customs procedure concerned; (b) carry out the customs controls for the verification of the customs declaration, referred to in points (a) and (b) of Article 188; (c) where justified, request that the customs office at which the goods are presented carry out the customs controls for the verification of the customs declaration referred to in points (c) and (d) of Article 188; and (d) carry out the customs formalities for the recovery of the amount of import or export duty corresponding to any customs debt. 4. The customs office at which the customs declaration is lodged and the customs office at which the goods are presented shall exchange the information necessary for the verification of the customs declaration and for the release of the goods. 5. The customs office at which the goods are presented shall, without prejudice to its own controls pertaining to goods brought into or taken out of the customs territory of the Union, carry out the customs controls referred to in point (c) of paragraph 3 and provide the customs office at which the customs declaration is lodged with the results of these controls. 6. The customs office at which the customs declaration is lodged shall release the goods in accordance with Articles 194 and 195, taking into account: (a) the results of its own controls for the verification of the customs declaration; (b) the results of the controls carried out by the customs office at which the goods are presented for the verification of the customs declaration and the controls pertaining to goods brought into or taken out of the customs territory of the Union. Article 180 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the conditions for granting the authorisation referred to in the first subparagraph of Article 179(1). Article 181 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules concerning: (a) the centralised clearance, including the relevant customs formalities and controls, referred to in Article 179; (b) the waiver from the obligation for goods to be presented referred to in Article 182(3) in the context of centralised clearance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 182 Entry in the declarant's records 1. The customs authorities may, upon application, authorise a person to lodge a customs declaration, including a simplified declaration, in the form of an entry in the declarant's records, provided that the particulars of that declaration are at the disposal of the customs authorities in the declarant's electronic system at the time when the customs declaration in the form of an entry in the declarant's records is lodged. 2. The customs declaration shall be deemed to have been accepted at the moment at which the goods are entered in the records. 3. The customs authorities may, upon application, waive the obligation for the goods to be presented. In that case, the goods shall be deemed to have been released at the moment of entry in the declarant's records. That waiver may be granted where all of the following conditions are fulfilled: (a) the declarant is an authorised economic operator for customs simplifications; (b) the nature and flow of the goods concerned so warrant and are known by the customs authority; (c) the supervising customs office has access to all the information it considers necessary to enable it to exercise its right to examine the goods should the need arise; (d) at the time of the entry into the records, the goods are no longer subject to prohibitions or restrictions, except where otherwise provided in the authorisation. However, the supervising customs office may, in specific situations, request that the goods be presented. 4. The conditions under which the release of the goods is allowed shall be set out in the authorisation. Article 183 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the conditions for granting the authorisation referred to in Article 182(1). Article 184 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on entry in the declarant's records referred to in Article 182, including the relevant customs formalities and controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 185 Self-assessment 1. Customs authorities may, upon application, authorise an economic operator to carry out certain customs formalities which are to be carried out by the customs authorities, to determine the amount of import and export duty payable, and to perform certain controls under customs supervision. 2. The applicant for the authorisation referred to in paragraph 1 shall be an authorised economic operator for customs simplifications. Article 186 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the conditions for granting the authorisation referred to in Article 185(1); (b) the customs formalities and the controls to be carried out by the holder of the authorisation referred to in Article 185(1). Article 187 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules regarding the customs formalities and the controls to be carried out by the holder of the authorisation in accordance with Article 185(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 3 Verification and release of goods Section 1 Verification Article 188 Verification of a customs declaration The customs authorities may, for the purpose of verifying the accuracy of the particulars contained in a customs declaration which has been accepted: (a) examine the declaration and the supporting documents; (b) require the declarant to provide other documents; (c) examine the goods; (d) take samples for analysis or for detailed examination of the goods. Article 189 Examination and sampling of goods 1. Transport of the goods to the places where they are to be examined and where samples are to be taken, and all the handling necessitated by such examination or taking of samples, shall be carried out by or under the responsibility of the declarant. The costs incurred shall be borne by the declarant. 2. The declarant shall have the right to be present or represented when the goods are examined and when samples are taken. Where the customs authorities have reasonable grounds for so doing, they may require the declarant to be present or represented when the goods are examined or samples are taken or to provide them with the assistance necessary to facilitate such examination or taking of samples. 3. Provided that samples are taken in accordance with the provisions in force, the customs authorities shall not be liable for payment of any compensation in respect thereof but shall bear the costs of their analysis or examination. Article 190 Partial examination and sampling of goods 1. Where only part of the goods covered by a customs declaration is examined, or samples are taken, the results of the partial examination, or of the analysis or examination of the samples, shall be taken to apply to all the goods covered by the same declaration. However, the declarant may request a further examination or sampling of the goods if he or she considers that the results of the partial examination, or of the analysis or examination of the samples taken, are not valid as regards the remainder of the goods declared. The request shall be granted provided that the goods have not been released or, if they have been released, that the declarant proves that they have not been altered in any way. 2. For the purposes of paragraph 1, where a customs declaration covers goods falling under two or more items, the particulars relating to goods falling under each item shall be deemed to constitute a separate declaration. Article 191 Results of the verification 1. The results of verifying the customs declaration shall be used for the application of the provisions governing the customs procedure under which the goods are placed. 2. Where the customs declaration is not verified, paragraph 1 shall apply on the basis of the particulars contained in that declaration. 3. The results of the verification made by the customs authorities shall have the same conclusive force throughout the customs territory of the Union. Article 192 Identification measures 1. The customs authorities or, where appropriate, economic operators authorised to do so by the customs authorities, shall take the measures necessary to identify the goods where identification is required in order to ensure compliance with the provisions governing the customs procedure for which those goods have been declared. Those identification measures shall have the same legal effect throughout the customs territory of the Union. 2. Means of identification affixed to the goods, packaging or means of transport shall be removed or destroyed only by the customs authorities or, where they are authorised to do so by the customs authorities, by economic operators, unless, as a result of unforeseeable circumstances or force majeure, their removal or destruction is essential to ensure the protection of the goods or the means of transport. Article 193 Conferral of implementing powers The Commission shall specify, by means of implementing acts, measures on the verification of the customs declaration, the examination and sampling of goods and the results of the verification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Release Article 194 Release of the goods 1. Where the conditions for placing the goods under the procedure concerned are fulfilled and provided that any restriction has been applied and the goods are not subject to any prohibition, the customs authorities shall release the goods as soon as the particulars in the customs declaration have been verified or are accepted without verification. The first subparagraph shall also apply where verification as referred to in Article 188 cannot be completed within a reasonable period of time and the goods are no longer required to be present for verification purposes. 2. All the goods covered by the same declaration shall be released at the same time. For the purposes of the first subparagraph, where a customs declaration covers goods falling under two or more items the particulars relating to goods falling under each item shall be deemed to constitute a separate customs declaration. Article 195 Release dependent upon payment of the amount of import or export duty corresponding to the customs debt or provision of a guarantee 1. Where the placing of goods under a customs procedure gives rise to a customs debt, the release of the goods shall be conditional upon the payment of the amount of import or export duty corresponding to the customs debt or the provision of a guarantee to cover that debt. However, without prejudice to the third subparagraph, the first subparagraph shall not apply to temporary admission with partial relief from import duty. Where, pursuant to the provisions governing the customs procedure for which the goods are declared, the customs authorities require the provision of a guarantee, those goods shall not be released for the customs procedure in question until such guarantee is provided. 2. In specific cases, the release of the goods shall not be conditional upon the provision of a guarantee in respect of goods which are the subject of a drawing request on a tariff quota. 3. Where a simplification as referred to in Articles 166, 182 and 185 is used and a comprehensive guarantee is provided, release of the goods shall not be conditional upon a monitoring of the guarantee by the customs authorities. Article 196 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the cases referred to in Article 195(2). CHAPTER 4 Disposal of goods Article 197 Destruction of goods Where the customs authorities have reasonable grounds for so doing, they may require goods which have been presented to customs to be destroyed and shall inform the holder of the goods accordingly. The costs of the destruction shall be borne by the holder of the goods. Article 198 Measures to be taken by the customs authorities 1. The customs authorities shall take any necessary measures, including confiscation and sale, or destruction, to dispose of goods in the following cases: (a) where one of the obligations laid down in the customs legislation concerning the introduction of non-Union goods into the customs territory of the Union has not been fulfilled, or the goods have been withheld from customs supervision; (b) where the goods cannot be released for any of the following reasons: (i) it has not been possible, for reasons attributable to the declarant, to undertake or continue examination of the goods within the period prescribed by the customs authorities; (ii) the documents which must be provided before the goods can be placed under, or released for, the customs procedure requested have not been provided; (iii) payments or a guarantee which should have been made or provided in respect of import or export duty, as the case may be, have not been made or provided within the prescribed period; (iv) the goods are subject to prohibitions or restrictions; (c) where the goods have not been removed within a reasonable period after their release; (d) where after their release, the goods are found not to have fulfilled the conditions for that release; or (e) where goods are abandoned to the State in accordance with Article 199. 2. Non-Union goods which have been abandoned to the State, seized or confiscated shall be deemed to be placed under the customs warehousing procedure. They shall be entered in the records of the customs warehousing operator, or, where they are held by the customs authorities, by the latter. Where goods to be destroyed, abandoned to the State, seized or confiscated are already subject to a customs declaration, the records shall include a reference to the customs declaration. Customs authorities shall invalidate that customs declaration. 3. The costs of the measures referred to in paragraph 1 shall be borne: (a) in the case referred to in point (a) of paragraph 1, by any person who was required to fulfil the obligations concerned or who withheld the goods from customs supervision; (b) in the cases referred to in points (b) and (c) of paragraph 1, by the declarant; (c) in the case referred to in point (d) of paragraph 1, by the person who is required to comply with the conditions governing the release of the goods; (d) in the case referred to in point (e) of paragraph 1, by the person who abandons the goods to the State. Article 199 Abandonment Non-Union goods and goods placed under the end-use procedure may with prior permission of the customs authorities be abandoned to the State by the holder of the procedure or, where applicable, the holder of the goods. Article 200 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on: (a) the destruction of goods, referred to in Article 197; (b) the sale of goods, referred to in Article 198(1); (c) abandonment of goods to the State in accordance with Article 199. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). TITLE VI RELEASE FOR FREE CIRCULATION AND RELIEF FROM IMPORT DUTY CHAPTER 1 Release for free circulation Article 201 Scope and effect 1. Non-Union goods intended to be put on the Union market or intended for private use or consumption within the customs territory of the Union shall be placed under release for free circulation. 2. Release for free circulation shall entail the following: (a) the collection of any import duty due; (b) the collection, as appropriate, of other charges, as provided for under relevant provisions in force relating to the collection of those charges; (c) the application of commercial policy measures and prohibitions and restrictions insofar as they do not have to be applied at an earlier stage; and (d) completion of the other formalities laid down in respect of the import of the goods. 3. Release for free circulation shall confer on non-Union goods the customs status of Union goods. Article 202 Commercial policy measures 1. Where processed products obtained under inward processing are released for free circulation and the calculation of the amount of import duty is made in accordance with Article 86(3), the commercial policy measures to be applied shall be those applicable to the release for free circulation of the goods which were placed under inward processing. 2. Paragraph 1 shall not apply to waste and scrap. 3. Where processed products obtained under inward processing are released for free circulation and the calculation of the amount of import duty is made in accordance with Article 85(1), the commercial policy measures applicable to those goods shall be applied only where the goods which were placed under inward processing are subject to such measures. 4. Where Union legislation establishes commercial policy measures on release for free circulation, such measures shall not apply to processed products released for free circulation following outward processing where: (a) the processed products retain their Union origin within the meaning of Article 60; (b) the outward processing involves repair, including the standard exchange system referred to in Article 261; or (c) the outward processing follows further processing operations in accordance with Article 258. CHAPTER 2 Relief from import duty Section 1 Returned goods Article 203 Scope and effect 1. Non-Union goods which, having originally been exported as Union goods from the customs territory of the Union, are returned to that territory within a period of three years and declared for release for free circulation shall, upon application by the person concerned, be granted relief from import duty. The first subparagraph shall apply even where the returned goods represent only a part of the goods previously exported from the customs territory of the Union. 2. The three-year period referred to in paragraph 1 may be exceeded in order to take account of special circumstances. 3. Where, prior to their export from the customs territory of the Union, the returned goods had been released for free circulation duty-free or at a reduced rate of import duty because of a particular end-use, relief from duty under paragraph 1 shall be granted only if they are to be released for free circulation for the same end-use. Where the end-use for which the goods in question are to be released for free circulation is no longer the same, the amount of import duty shall be reduced by any amount collected on the goods when they were first released for free circulation. Should the latter amount exceed that levied on the release for free circulation of the returned goods, no repayment shall be granted. 4. Where Union goods have lost their customs status as Union goods pursuant to Article 154 and are subsequently released for free circulation, paragraphs 1, 2 and 3 shall apply. 5. The relief from import duty shall be granted only if goods are returned in the state in which they were exported. 6. The relief from import duty shall be supported by information establishing that the conditions for the relief are fulfilled. Article 204 Goods which benefited from measures laid down under the common agricultural policy Relief from import duty provided for in Article 203 shall not be granted to goods which have benefited from measures laid down under the common agricultural policy involving their export out of the customs territory of the Union, except where otherwise provided in specific cases. Article 205 Goods previously placed under the inward processing procedure 1. Article 203 shall apply to processed products which were originally re-exported from the customs territory of the Union subsequent to an inward processing procedure. 2. Upon application by the declarant and provided the declarant submits the necessary information, the amount of import duty on the goods covered by paragraph 1 shall be determined in accordance with Article 86(3). The date of acceptance of the re-export declaration shall be regarded as the date of release for free circulation. 3. The relief from import duty provided for in Article 203 shall not be granted for processed products which were exported in accordance with point (c) of Article 223(2), unless it is ensured that no goods will be placed under the inward processing procedure. Article 206 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the cases where goods are considered to be returned in the state in which they were exported; (b) the specific cases referred to in Article 204. Article 207 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the provision of information referred to in Article 203(6). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Sea-fishing and products taken from the sea Article 208 Products of sea-fishing and other products taken from the sea 1. Without prejudice to Article 60(1), the following shall be granted relief from import duty when they are released for free circulation: (a) products of sea-fishing and other products taken from the territorial sea of a country or territory outside the customs territory of the Union by vessels solely registered or recorded in a Member State and flying the flag of that State; (b) products obtained from products referred to in point (a) on board factory-ships fulfilling the conditions laid down in that point. 2. The relief from import duty referred to in paragraph 1 shall be supported by evidence that the conditions laid down in that paragraph are fulfilled. Article 209 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the provision of the evidence referred to in Article 208(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). TITLE VII SPECIAL PROCEDURES CHAPTER 1 General provisions Article 210 Scope Goods may be placed under any of the following categories of special procedures: (a) transit, which shall comprise external and internal transit; (b) storage, which shall comprise customs warehousing and free zones; (c) specific use, which shall comprise temporary admission and end-use; (d) processing, which shall comprise inward and outward processing. Article 211 Authorisation 1. An authorisation from the customs authorities shall be required for the following: (a) the use of the inward or outward processing procedure, the temporary admission procedure or the end-use procedure; (b) the operation of storage facilities for the customs warehousing of goods, except where the storage facility operator is the customs authority itself. The conditions under which the use of one or more of the procedures referred to in the first subparagraph or the operation of storage facilities is permitted shall be set out in the authorisation. 2. The customs authorities shall grant an authorisation with retroactive effect, where all of the following conditions are fulfilled: (a) there is a proven economic need; (b) the application is not related to attempted deception; (c) the applicant has proven on the basis of accounts or records that: (i) all the requirements of the procedure are met; (ii) where appropriate, the goods can be identified for the period involved; (iii) such accounts or records allow the procedure to be controlled; (d) all the formalities necessary to regularise the situation of the goods can be carried out, including, where necessary, the invalidation of the customs declarations concerned; (e) no authorisation with retroactive effect has been granted to the applicant within three years of the date on which the application was accepted; (f) an examination of the economic conditions is not required, except where an application concerns renewal of an authorisation for the same kind of operation and goods; (g) the application does not concern the operation of storage facilities for the customs warehousing of goods; (h) where an application concerns renewal of an authorisation for the same kind of operation and goods, the application is submitted within three years of expiry of the original authorisation. Customs authorities may grant an authorisation with retroactive effect also where the goods which were placed under a customs procedure are no longer available at the time when the application for such authorisation was accepted. 3. Except where otherwise provided, the authorisation referred to in paragraph 1 shall be granted only to persons who satisfy all of the following conditions: (a) they are established in the customs territory of the Union; (b) they provide the necessary assurance of the proper conduct of the operations; an authorised economic operator for customs simplifications shall be deemed to fulfil this condition, insofar as the activity pertaining to the special procedure concerned is taken into account in the authorisation referred to in point (a) of Article 38(2); (c) where a customs debt or other charges may be incurred for goods placed under a special procedure, they provide a guarantee in accordance with Article 89; (d) in the case of the temporary admission or inward processing procedure, they use the goods or arrange for their use or they carry out processing operations on the goods or arrange for them to be carried out, respectively. 4. Except where otherwise provided and in addition to paragraph 3, the authorisation referred to in paragraph 1 shall be granted only where all of the following conditions are fulfilled: (a) the customs authorities are able to exercise customs supervision without having to introduce administrative arrangements disproportionate to the economic needs involved; (b) the essential interests of Union producers would not be adversely affected by an authorisation for a processing procedure (economic conditions). 5. The essential interests of Union producers shall be deemed not to be adversely affected, as referred to in point (b) of paragraph 4, except where evidence to the contrary exists or where the economic conditions are deemed to be fulfilled. 6. Where evidence exists that the essential interests of Union producers are likely to be adversely affected, an examination of the economic conditions shall take place at Union level. Article 212 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the conditions for granting the authorisation for the procedures referred to in Article 211(1); (b) the exceptions to the conditions referred to in Article 211(3) and (4); (c) the cases in which the economic conditions are deemed to be fulfilled as referred to in Article 211(5). Article 213 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for examining the economic conditions referred to in Article 211(6). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 214 Records 1. Except for the transit procedure, or where otherwise provided, the holder of the authorisation, the holder of the procedure, and all persons carrying on an activity involving the storage, working or processing of goods, or the sale or purchase of goods in free zones, shall keep appropriate records in a form approved by the customs authorities. The records shall contain the information and the particulars which enable the customs authorities to supervise the procedure concerned, in particular with regard to identification of the goods placed under that procedure, their customs status and their movements. 2. An authorised economic operator for customs simplifications shall be deemed to comply with the obligation laid down in paragraph 1 insofar as his or her records are appropriate for the purpose of the special procedure concerned. Article 215 Discharge of a special procedure 1. In cases other than the transit procedure and without prejudice to Article 254, a special procedure shall be discharged when the goods placed under the procedure, or the processed products, are placed under a subsequent customs procedure, have been taken out of the customs territory of the Union, or have been destroyed with no waste remaining, or are abandoned to the State in accordance with Article 199. 2. The transit procedure shall be discharged by the customs authorities when they are in a position to establish, on the basis of a comparison of the data available to the customs office of departure and those available to the customs office of destination, that the procedure has ended correctly. 3. The customs authorities shall take all the measures necessary to regularise the situation of the goods in respect of which a procedure has not been discharged under the conditions prescribed. 4. The discharge of the procedure shall take place within a certain time-limit, unless otherwise provided. Article 216 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the time-limit referred to in Article 215(4). Article 217 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the discharge of a special procedure, referred to in Article 216. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 218 Transfer of rights and obligations The rights and obligations of the holder of a procedure with regard to goods which have been placed under a special procedure other than transit may be fully or partially transferred to another person who fulfils the conditions laid down for the procedure concerned. Article 219 Movement of goods In specific cases, goods placed under a special procedure other than transit or in a free zone may be moved between different places in the customs territory of the Union. Article 220 Usual forms of handling Goods placed under customs warehousing or a processing procedure or in a free zone may undergo usual forms of handling intended to preserve them, improve their appearance or marketable quality or prepare them for distribution or resale. Article 221 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284: (a) laying down the cases and the conditions for the movement of goods placed under a special procedure other than transit or in a free zone in accordance with Article 219; (b) determining the usual forms of handling for goods placed under customs warehousing or a processing procedure or in a free zone as referred to in Article 220. Article 222 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) transferring the rights and obligations of the holder of the procedure with regard to goods which have been placed under a special procedure other than transit in accordance with Article 218; (b) the movement of goods placed under a special procedure other than transit or in a free zone in accordance with Article 219. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 223 Equivalent goods 1. Equivalent goods shall consist in Union goods which are stored, used or processed instead of the goods placed under a special procedure. Under the outward processing procedure, equivalent goods shall consist in non-Union goods which are processed instead of Union goods placed under the outward processing procedure. Except where otherwise provided, equivalent goods shall have the same eight-digit Combined Nomenclature code, the same commercial quality and the same technical characteristics as the goods which they are replacing. 2. The customs authorities shall, upon application, authorise the following, provided that the proper conduct of the procedure, in particular as regards customs supervision, is ensured: (a) the use of equivalent goods under customs warehousing, free zones, end-use and a processing procedure; (b) the use of equivalent goods under the temporary admission procedure, in specific cases; (c) in the case of the inward processing procedure, the export of processed products obtained from equivalent goods before the import of the goods they are replacing; (d) in the case of the outward processing procedure, the import of processed products obtained from equivalent goods before the export of the goods they are replacing. An authorised economic operator for customs simplifications shall be deemed to fulfil the condition that the proper conduct of the procedure is ensured, insofar as the activity pertaining to the use of equivalent goods for the procedure concerned is taken into account in the authorisation referred to in point (a) of Article 38(2). 3. The use of equivalent goods shall not be authorised in any of the following cases: (a) where only usual forms of handling as defined in Article 220 are carried out under the inward processing procedure; (b) where a prohibition of drawback of, or exemption from, import duty applies to non-originating goods used in the manufacture of processed products under the inward processing procedure, for which a proof of origin is issued or made out in the framework of a preferential arrangement between the Union and certain countries or territories outside the customs territory of the Union or groups of such countries or territories; (c) where it would lead to an unjustified import duty advantage or where provided for in Union legislation. 4. In the case referred to in point (c) of paragraph 2, and where the processed products would be liable to export duty if they were not being exported in the context of the inward processing procedure, the holder of the authorisation shall provide a guarantee to ensure payment of the export duty should the non-Union goods not be imported within the period referred to in Article 257(3). Article 224 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the exceptions from the third subparagraph of Article 223(1); (b) the conditions under which equivalent goods are used in accordance with Article 223(2); (c) the specific cases where equivalent goods are used under the temporary admission procedure, in accordance with point (b) of Article 223(2); (d) the cases where the use of equivalent goods is not authorised in accordance with point (c) of Article 223(3). Article 225 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the use of equivalent goods authorised in accordance with Article 223(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 2 Transit Section 1 External and internal transit Article 226 External transit 1. Under the external transit procedure, non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to any of the following: (a) import duty; (b) other charges as provided for under other relevant provisions in force; (c) commercial policy measures, insofar as they do not prohibit the entry or exit of goods into or from the customs territory of the Union. 2. In specific cases, Union goods shall be placed under the external transit procedure. 3. Movement as referred to in paragraph 1 shall take place in one of the following ways: (a) under the external Union transit procedure; (b) in accordance with the TIR Convention, provided that such movement: (i) began or is to end outside the customs territory of the Union; (ii) is effected between two points in the customs territory of the Union through the territory of a country or territory outside the customs territory of the Union; (c) in accordance with the ATA Convention/Istanbul Convention, where a transit movement takes place; (d) under cover of the Rhine Manifest (Article 9 of the Revised Convention for the Navigation of the Rhine); (e) under cover of form 302 provided for in the Agreement between the Parties to the North Atlantic Treaty regarding the Status of their Forces, signed in London on 19 June 1951; (f) under the postal system in accordance with the acts of the Universal Postal Union, when the goods are carried by or for holders of rights and obligations under such acts. Article 227 Internal transit 1. Under the internal transit procedure, and under the conditions laid down in paragraph 2, Union goods may be moved from one point to another within the customs territory of the Union, and pass through a country or territory outside that customs territory, without any change in their customs status. 2. The movement referred to in paragraph 1 shall take place in one of the following ways: (a) under the internal Union transit procedure provided that such a possibility is provided for in an international agreement; (b) in accordance with the TIR Convention; (c) in accordance with the ATA Convention/Istanbul Convention, where a transit movement takes place; (d) under cover of the Rhine Manifest (Article 9 of the Revised Convention for the Navigation of the Rhine); (e) under cover of form 302 as provided for in the Agreement between the Parties to the North Atlantic Treaty regarding the Status of their Forces, signed in London on 19 June 1951; (f) under the postal system in accordance with the acts of the Universal Postal Union, when the goods are carried by or for holders of rights and obligations under such acts. Article 228 Single territory for transit purposes Where goods are moved from one point in the customs territory of the Union to another in accordance with the TIR Convention, the ATA Convention / Istanbul Convention, under cover of form 302 or under the postal system, the customs territory of the Union shall, for the purposes of such transport, be considered to form a single territory. Article 229 Exclusion of persons from TIR operations 1. Where the customs authorities of a Member State decide to exclude a person from TIR operations under Article 38 of the TIR Convention, that decision shall apply throughout the customs territory of the Union and TIR carnets lodged by that person shall not be accepted by any customs office. 2. A Member State shall communicate its decision referred to in paragraph 1, together with the date of its application, to the other Member States and to the Commission. Article 230 Authorised consignee for TIR purposes The customs authorities may, upon application, authorise a person, referred to as an 'authorised consignee' to receive goods moved in accordance with the TIR Convention at an authorised place, so that the procedure is terminated in accordance with point (d) of Article 1 of the TIR Convention. Article 231 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the specific cases where Union goods are to be placed under the external transit procedure in accordance with Article 226(2); (b) the conditions for the granting of the authorisation referred to in Article 230. Article 232 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules to apply points (b) to (f) of Article 226(3) and points (b) to (f) of Article 227(2) in the customs territory of the Union, taking into account the needs of the Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Union transit Article 233 Obligations of the holder of the Union transit procedure and of the carrier and recipient of goods moving under the Union transit procedure 1. The holder of the Union transit procedure shall be responsible for all of the following: (a) presentation of the goods intact and the required information at the customs office of destination within the prescribed time-limit and in compliance with the measures taken by the customs authorities to ensure their identification; (b) observance of the customs provisions relating to the procedure; (c) unless otherwise provided for in the customs legislation, provision of a guarantee in order to ensure payment of the amount of import or export duty corresponding to any customs debt or other charges, as provided for under other relevant provisions in force, which may be incurred in respect of the goods. 2. The obligation of the holder of the procedure shall be met and the transit procedure shall end when the goods placed under the procedure and the required information are available at the customs office of destination in accordance with the customs legislation. 3. A carrier or recipient of goods who accepts goods knowing that they are moving under the Union transit procedure shall also be responsible for presentation of the goods intact at the customs office of destination within the prescribed time-limit and in compliance with the measures taken by the customs authorities to ensure their identification. 4. Upon application, the customs authorities may authorise any of the following simplifications regarding the placing of goods under the Union transit procedure or the end of that procedure: (a) the status of authorised consignor, allowing the holder of the authorisation to place goods under the Union transit procedure without presenting them to customs; (b) the status of authorised consignee, allowing the holder of the authorisation to receive goods moved under the Union transit procedure at an authorised place, to end the procedure in accordance with Article 233(2); (c) the use of seals of a special type, where sealing is required to ensure the identification of the goods placed under the Union transit procedure; (d) the use of a customs declaration with reduced data requirements to place goods under the Union transit procedure; (e) the use of an electronic transport document as customs declaration to place goods under the Union transit procedure, provided it contains the particulars of such declaration and those particulars are available to the customs authorities at departure and at destination to allow the customs supervision of the goods and the discharge of the procedure. Article 234 Goods passing through the territory of a country or territory outside the customs territory of the Union under the external Union transit procedure 1. The external Union transit procedure shall apply to goods passing through a country or a territory outside the customs territory of the Union if one of the following conditions is fulfilled: (a) provision is made to that effect under an international agreement; (b) carriage through that country or territory is effected under cover of a single transport document drawn up in the customs territory of the Union. 2. In the case referred to in point (b) of paragraph 1, the operation of the external Union transit procedure shall be suspended while the goods are outside the customs territory of the Union. Article 235 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the conditions for granting the authorisations referred to in Article 233(4). Article 236 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on: (a) the placing of goods under the Union transit procedure and the end of that procedure; (b) the operation of the simplifications referred to in Article 233(4); (c) the customs supervision of goods passing through the territory of a country or territory outside the customs territory of the Union under the external Union transit procedure, referred to in Article 234. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 3 Storage Section 1 Common provisions Article 237 Scope 1. Under a storage procedure, non-Union goods may be stored in the customs territory of the Union without being subject to any of the following: (a) import duty; (b) other charges as provided for under other relevant provisions in force; (c) commercial policy measures, insofar as they do not prohibit the entry or exit of goods into or from the customs territory of the Union. 2. Union goods may be placed under the customs warehousing or free zone procedure in accordance with Union legislation governing specific fields, or in order to benefit from a decision granting repayment or remission of import duty. 3. The customs authorities may, where an economic need exists and customs supervision will not be adversely affected, authorise the storage of Union goods in a storage facility for customs warehousing. Those goods shall not be regarded as being under the customs warehousing procedure. Article 238 Duration of a storage procedure 1. There shall be no limit to the length of time goods may remain under a storage procedure. 2. In exceptional circumstances, the customs authorities may set a time-limit by which a storage procedure must be discharged in particular where the type and nature of the goods may, in the case of long-term storage, pose a threat to human, animal or plant health or to the environment. Article 239 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the placing of Union goods under the customs warehousing or free zone procedure as referred to in Article 237(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Customs warehousing Article 240 Storage in customs warehouses 1. Under the customs warehousing procedure non-Union goods may be stored in premises or any other location authorised for that procedure by the customs authorities and under customs supervision ('customs warehouses'). 2. Customs warehouses may be available for use by any person for the customs warehousing of goods ('public customs warehouse'), or for the storage of goods by the holder of an authorisation for customs warehousing ('private customs warehouse'). 3. Goods placed under the customs warehousing procedure may be temporarily removed from the customs warehouse. Such removal shall, except in case of force majeure, be authorised in advance by the customs authorities. Article 241 Processing 1. The customs authorities may, where an economic need exists and customs supervision is not adversely affected, authorise the processing of goods under the inward processing or end-use procedure to take place in a customs warehouse, subject to the conditions provided for by those procedures. 2 The goods referred to in paragraph 1 shall not be regarded as being under the customs warehousing procedure. Article 242 Responsibilities of the holder of the authorisation or procedure 1. The holder of the authorisation and the holder of the procedure shall be responsible for the following: (a) ensuring that goods under the customs warehousing procedure are not removed from customs supervision; and (b) fulfilling the obligations arising from the storage of goods covered by the customs warehousing procedure. 2. By way of derogation from paragraph 1, where the authorisation concerns a public customs warehouse, it may provide that the responsibilities referred to in points (a) or (b) of paragraph 1 devolve exclusively upon the holder of the procedure. 3. The holder of the procedure shall be responsible for fulfilling the obligations arising from the placing of the goods under the customs warehousing procedure. Section 3 Free zones Article 243 Designation of free zones 1. Member States may designate parts of the customs territory of the Union as free zones. For each free zone the Member State shall determine the area covered and define the entry and exit points. 2. Member States shall communicate to the Commission information on their free zones which are in operation. 3. Free zones shall be enclosed. The perimeter and the entry and exit points of the area of free zones shall be subject to customs supervision. 4. Persons, goods and means of transport entering or leaving free zones may be subject to customs controls. Article 244 Buildings and activities in free zones 1. The construction of any building in a free zone shall require the prior approval of the customs authorities. 2. Subject to the customs legislation, any industrial, commercial or service activity shall be permitted in a free zone. The carrying on of such activities shall be subject to notification, in advance, to the customs authorities. 3. The customs authorities may impose prohibitions or restrictions on the activities referred to in paragraph 2, having regard to the nature of the goods in question, or the requirements of customs supervision, or security and safety requirements. 4. The customs authorities may prohibit persons who do not provide the necessary assurance of compliance with the customs provisions from carrying on an activity in a free zone. Article 245 Presentation of goods and their placing under the procedure 1. Goods brought into a free zone shall be presented to customs and undergo the prescribed customs formalities in any of the following cases: (a) where they are brought into the free zone directly from outside the customs territory of the Union; (b) where they have been placed under a customs procedure which is ended or discharged when they are placed under the free zone procedure; (c) where they are placed under the free zone procedure in order to benefit from a decision granting repayment or remission of import duty; (d) where legislation other than the customs legislation provides for such formalities. 2. Goods brought into a free zone in circumstances other than those covered by paragraph 1 shall not be presented to customs. 3. Without prejudice to Article 246, goods brought into a free zone are deemed to be placed under the free zone procedure: (a) at the moment of their entry into a free zone, unless they have already been placed under another customs procedure; or (b) at the moment when a transit procedure is ended, unless they are immediately placed under a subsequent customs procedure. Article 246 Union goods in free zones 1. Union goods may be entered, stored, moved, used, processed or consumed in a free zone. In such cases the goods shall not be regarded as being under the free zone procedure. 2. Upon application by the person concerned, the customs authorities shall establish the customs status as Union goods of any of the following goods: (a) Union goods which enter a free zone; (b) Union goods which have undergone processing operations within a free zone; (c) goods released for free circulation within a free zone. Article 247 Non-Union goods in free zones 1. Non-Union goods may, while they remain in a free zone, be released for free circulation or be placed under the inward processing, temporary admission or end-use procedure, under the conditions laid down for those procedures. In such cases the goods shall not be regarded as being under the free zone procedure. 2. Without prejudice to the provisions applicable to supplies or to victualling storage, where the procedure concerned so provides, paragraph 1 shall not preclude the use or consumption of goods of which the release for free circulation or temporary admission would not entail application of import duty or measures laid down under the common agricultural or commercial policies. In the case of such use or consumption, no customs declaration for the release for free circulation or temporary admission procedure shall be required. Such declaration shall, however, be required if such goods are subject to a tariff quota or ceiling. Article 248 Taking goods out of a free zone 1. Without prejudice to legislation in fields other than customs, goods in a free zone may be exported or re-exported from the customs territory of the Union, or brought into another part of the customs territory of the Union. 2. Articles 134 to 149 shall apply to goods taken out of a free zone into other parts of the customs territory of the Union. Article 249 Customs status Where goods are taken out of a free zone into another part of the customs territory of the Union or placed under a customs procedure, they shall be regarded as non-Union goods unless their customs status as Union goods has been proven. However, for the purposes of applying export duty and export licences or export control measures laid down under the common agricultural or commercial policies, such goods shall be regarded as Union goods, unless it is established that they do not have the customs status of Union goods. CHAPTER 4 Specific use Section 1 Temporary admission Article 250 Scope 1. Under the temporary admission procedure non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to any of the following: (a) other charges as provided for under other relevant provisions in force; (b) commercial policy measures, insofar as they do not prohibit the entry or exit of goods into or from the customs territory of the Union. 2. The temporary admission procedure may only be used provided that the following conditions are met: (a) the goods are not intended to undergo any change, except normal depreciation due to the use made of them; (b) it is possible to ensure that the goods placed under the procedure can be identified, except where, in view of the nature of the goods or of the intended use, the absence of identification measures is not liable to give rise to any abuse of the procedure or, in the case referred to in Article 223, where compliance with the conditions laid down in respect of equivalent goods can be verified; (c) the holder of the procedure is established outside the customs territory of the Union, except where otherwise provided; (d) the requirements for total or partial duty relief laid down in the customs legislation are met. Article 251 Period during which goods may remain under the temporary admission procedure 1. The customs authorities shall determine the period within which goods placed under the temporary admission procedure must be re-exported or placed under a subsequent customs procedure. Such period shall be long enough for the objective of authorised use to be achieved. 2. Except where otherwise provided, the maximum period during which goods may remain under the temporary admission procedure for the same purpose and under the responsibility of the same authorisation holder shall be 24 months, even where the procedure was discharged by placing the goods under another special procedure and subsequently placing them under the temporary admission procedure again. 3. Where, in exceptional circumstances, the authorised use cannot be achieved within the period referred to in paragraphs 1 and 2, the customs authorities may grant an extension, of reasonable duration of that period, upon justified application by the holder of the authorisation. 4. The overall period during which goods may remain under the temporary admission procedure shall not exceed 10 years, except in the case of an unforeseeable event. Article 252 Amount of import duty in case of temporary admission with partial relief from import duty 1. The amount of import duty in respect of goods placed under the temporary admission procedure with partial relief from import duty shall be set at 3 % of the amount of import duty which would have been payable on those goods had they been released for free circulation on the date on which they were placed under the temporary admission procedure. That amount shall be payable for every month or fraction of a month during which the goods have been placed under the temporary admission procedure with partial relief from import duty. 2. The amount of import duty shall not exceed that which would have been payable if the goods in question had been released for free circulation on the date on which they were placed under the temporary admission procedure. Article 253 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 243, in order to determine: (a) the specific use referred to in Article 250(1); (b) the requirements referred to in point (d) of Article 250(2). Section 2 End-use Article 254 End-use procedure 1. Under the end-use procedure, goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use. 2. Where the goods are at a production stage which would allow economically the prescribed end-use only, the customs authorities may establish in the authorisation the conditions under which the goods shall be deemed to have been used for the purposes laid down for applying the duty exemption or reduced rate of duty. 3. Where goods are suitable for repeated use and the customs authorities consider it appropriate in order to avoid abuse, customs supervision shall continue for a period not exceeding two years after the date of their first use for the purposes laid down for applying the duty exemption or reduced rate of duty. 4. Customs supervision under the end-use procedure shall end in any of the following cases: (a) where the goods have been used for the purposes laid down for the application of the duty exemption or reduced rate of duty; (b) where the goods have been taken out of the customs territory of the Union, destroyed or abandoned to the State; (c) where the goods have been used for purposes other than those laid down for the application of the duty exemption or reduced duty rate and the applicable import duty has been paid. 5. Where a rate of yield is required, Article 255 shall apply to the end-use procedure. 6. Waste and scrap which result from the working or processing of goods according to the prescribed end-use and losses due to natural wastage shall be considered as goods assigned to the prescribed end-use. 7. Waste and scrap resulting from the destruction of goods placed under the end-use procedure shall be deemed to be placed under the customs warehousing procedure. CHAPTER 5 Processing Section 1 General provisions Article 255 Rate of yield Except where a rate of yield has been specified in Union legislation governing specific fields, the customs authorities shall set either the rate of yield or average rate of yield of the processing operation or where appropriate, the method of determining such rate. The rate of yield or average rate of yield shall be determined on the basis of the actual circumstances in which processing operations are, or are to be, carried out. That rate may be adjusted, where appropriate, in accordance with Article 28. Section 2 Inward processing Article 256 Scope 1. Without prejudice to Article 223, under the inward processing procedure non-Union goods may be used in the customs territory of the Union in one or more processing operations without such goods being subject to any of the following: (a) import duty; (b) other charges as provided for under other relevant provisions in force; (c) commercial policy measures, insofar as they do not prohibit the entry or exit of goods into or from the customs territory of the Union. 2. The inward processing procedure may be used in cases other than repair and destruction only where, without prejudice to the use of production accessories, the goods placed under the procedure can be identified in the processed products. In the case referred to in Article 223, the procedure may be used where compliance with the conditions laid down in respect of equivalent goods can be verified. 3. In addition to paragraphs 1 and 2, the inward processing procedure may also be used for any of the following goods: (a) goods intended to undergo operations to ensure their compliance with technical requirements for their release for free circulation; (b) goods which have to undergo usual forms of handling in accordance with Article 220. Article 257 Period for discharge 1. The customs authorities shall specify the period within which the inward processing procedure is to be discharged, in accordance with Article 216. That period shall run from the date on which the non-Union goods are placed under the procedure and shall take account of the time required to carry out the processing operations and to discharge the procedure. 2. The customs authorities may grant an extension, of reasonable duration, of the period specified pursuant to paragraph 1, upon justified application by the holder of the authorisation. The authorisation may specify that a period which commences in the course of a month, quarter or semester shall end on the last day of a subsequent month, quarter or semester respectively. 3. In the case of prior export in accordance with point (c) of Article 223(2), the authorisation shall specify the period within which the non-Union goods shall be declared for the inward processing procedure, taking account of the time required for procurement and transport to the customs territory of the Union. The period referred to in the first subparagraph shall be set in months and shall not exceed six months. It shall run from the date of acceptance of the export declaration relating to the processed products obtained from the corresponding equivalent goods. 4. At the request of the holder of the authorisation, the period of six months referred to in paragraph 3 may be extended, even after its expiry, provided that the total period does not exceed 12 months. Article 258 Temporary re-export for further processing Upon application, the customs authorities may authorise some or all of the goods placed under the inward -processing procedure, or the processed products, to be temporarily re-exported for the purpose of further processing outside the customs territory of the Union, in accordance with the conditions laid down for the outward processing procedure. Section 3 Outward processing Article 259 Scope 1. Under the outward processing procedure Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duty upon application by the holder of the authorisation or any other person established in the customs territory of the Union provided that that person has obtained the consent of the holder of the authorisation and the conditions of the authorisation are fulfilled. 2. Outward processing shall not be allowed for any of the following Union goods: (a) goods the export of which gives rise to repayment or remission of import duty; (b) goods which, prior to export, were released for free circulation under a duty exemption or at a reduced rate of duty by virtue of their end-use, for as long as the purposes of such end-use have not been fulfilled, unless those goods have to undergo repair operations; (c) goods the export of which gives rise to the granting of export refunds; (d) goods in respect of which a financial advantage other than refunds referred to in point (c) is granted under the common agricultural policy by virtue of the export of those goods. 3. The customs authorities shall specify the period within which goods temporarily exported must be re-imported into the customs territory of the Union in the form of processed products, and released for free circulation, in order to be able to benefit from total or partial relief from import duty. They may grant an extension, of reasonable duration, of that period, upon justified application by the holder of the authorisation. Article 260 Goods repaired free of charge 1. Where it is established to the satisfaction of the customs authorities that goods have been repaired free of charge, either because of a contractual or statutory obligation arising from a guarantee or because of a manufacturing or material defect, they shall be granted total relief from import duty. 2. Paragraph 1 shall not apply where account was taken of the manufacturing or material defect at the time when the goods in question were first released for free circulation. Article 261 Standard exchange system 1. Under the standard exchange system an imported product ('replacement product') may, in accordance with paragraphs 2 to 5, replace a processed product. 2. The customs authorities shall, upon application authorise the standard exchange system to be used where the processing operation involves the repair of defective Union goods other than those subject to measures laid down under the common agricultural policy or to the specific arrangements applicable to certain goods resulting from the processing of agricultural products. 3. Replacement products shall have the same eight-digit Combined Nomenclature code, the same commercial quality and the same technical characteristics as the defective goods had the latter undergone repair. 4. Where the defective goods have been used before export, the replacement products must also have been used. The customs authorities shall, however, waive the requirement set out in the first subparagraph if the replacement product has been supplied free of charge, either because of a contractual or statutory obligation arising from a guarantee or because of a material or manufacturing defect. 5. The provisions which would be applicable to the processed products shall apply to the replacement products. Article 262 Prior import of replacement products 1. The customs authorities shall, under the conditions they lay down, upon application by the person concerned, authorise replacement products to be imported before the defective goods are exported. In the event of such prior import of a replacement product, a guarantee shall be provided, covering the amount of the import duty that would be payable should the defective goods not be exported in accordance with paragraph 2. 2. The defective goods shall be exported within a period of two months from the date of acceptance by the customs authorities of the declaration for the release for free circulation of the replacement products. 3. Where, in exceptional circumstances, the defective goods cannot be exported within the period referred to in paragraph 2, the customs authorities may grant an extension, of a reasonable duration, of that period, upon justified application by the holder of the authorisation. TITLE VIII GOODS TAKEN OUT OF THE CUSTOMS TERRITORY OF THE UNION CHAPTER 1 Formalities prior to the exit of goods Article 263 Lodging a pre-departure declaration 1. Goods to be taken out of the customs territory of the Union shall be covered by a pre-departure declaration to be lodged at the competent customs office within a specific time-limit before the goods are taken out of the customs territory of the Union. 2. The obligation referred to in paragraph 1 shall be waived: (a) for means of transport and the goods carried thereon only passing through the territorial waters or the airspace of the customs territory of the Union without a stop within that territory; or (b) in other specific cases, where duly justified by the type of goods or traffic or where required by international agreements. 3. The pre-departure declaration shall take the form of one of the following: (a) a customs declaration, where the goods to be taken out of the customs territory of the Union are placed under a customs procedure for which such declaration is required; (b) a re-export declaration, in accordance with Article 270; (c) an exit summary declaration, in accordance with Article 271. 4. The pre-departure declaration shall contain the particulars necessary for risk analysis for security and safety purposes. Article 264 Risk analysis The customs office to which the pre-departure declaration referred to in Article 263 is lodged shall ensure that, within a specific time-limit, a risk analysis is carried out, primarily for security and safety purposes, on the basis of that declaration and shall take the necessary measures based on the results of that risk analysis. Article 265 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the specific time-limit, referred to in Article 263(1), within which the pre-departure declaration is to be lodged before the goods are taken out of the customs territory of the Union taking into account the type of traffic; (b) the specific cases where the obligation to lodge a pre-departure declaration is waived in accordance with point (c) of Article 263(2). Article 266 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the time-limit referred to in Article 264, within which risk analysis is to be carried out taking into account the time-limit referred to in Article 263(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 2 Formalities on exit of goods Article 267 Customs supervision and formalities on exit 1. Goods to be taken out of the customs territory of the Union shall be subject to customs supervision and may be subject to customs controls. Where appropriate, the customs authorities may determine the route to be used, and the time-limit to be respected when goods are to be taken out of the customs territory of the Union. 2. Goods to be taken out of the customs territory of the Union shall be presented to customs on exit by one of the following persons: (a) the person who takes the goods out of the customs territory of the Union; (b) the person in whose name or on whose behalf the person who takes the goods out of the customs territory of the Union acts; (c) the person who assumes responsibility for the carriage of the goods prior to their exit from the customs territory of the Union. 3. Goods to be taken out of the customs territory of the Union shall be subject, as appropriate, to the following: (a) the repayment or remission of import duty; (b) the payment of export refunds; (c) the collection of export duty; (d) the formalities required under provisions in force with regard to other charges; (e) the application of prohibitions and restrictions justified on grounds of, inter alia, public morality, public policy or public security, the protection of the health and life of humans, animals or plants, the protection of the environment, the protection of national treasures possessing artistic, historic or archaeological value and the protection of industrial or commercial property, including controls against drug precursors, goods infringing certain intellectual property rights and cash, as well as the implementation of fishery conservation and management measures and of commercial policy measures. 4. Release for exit shall be granted by the customs authorities on condition that the goods in question will be taken out of the customs territory of the Union in the same condition as when: (a) the customs or re-export declaration was accepted; or (b) the exit summary declaration was lodged. Article 268 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on the exit referred to in Article 267. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 3 Export and re-export Article 269 Export of Union goods 1. Union goods to be taken out of the customs territory of the Union shall be placed under the export procedure. 2. Paragraph 1 shall not apply to any of the following Union goods: (a) goods placed under the outward processing procedure; (b) goods taken out of the customs territory of the Union after having been placed under the end-use procedure; (c) goods delivered, VAT or excise duty exempted, as aircraft or ship supplies, regardless of the destination of the aircraft or ship, for which a proof of such supply is required; (d) goods placed under the internal transit procedure; (e) goods moved temporarily out of the customs territory of the Union in accordance with Article 155. 3. The formalities concerning the export customs declaration laid down in the customs legislation shall apply in the cases referred to in points (a), (b) and (c) of paragraph 2. Article 270 Re-export of non-Union goods 1. Non-Union goods to be taken out of the customs territory of the Union shall be subject to a re-export declaration to be lodged at the competent customs office. 2. Articles 158 to 195 shall apply to the re-export declaration. 3. Paragraph 1 shall not apply to any of the following goods: (a) goods placed under the external transit procedure which only pass through the customs territory of the Union; (b) goods trans-shipped within, or directly re-exported from, a free zone; (c) goods in temporary storage which are directly re-exported from a temporary storage facility. CHAPTER 4 Exit summary declaration Article 271 Lodging an exit summary declaration 1. Where goods are to be taken out of the customs territory of the Union and a customs declaration or a re-export declaration is not lodged as pre-departure declaration, an exit summary declaration shall be lodged at the customs office of exit. Customs authorities may allow the exit summary declaration to be lodged at another customs office, provided that the latter immediately communicates or makes available electronically the necessary particulars to the customs office of exit. 2. The exit summary declaration shall be lodged by the carrier. Notwithstanding the obligations of the carrier, the exit summary declaration may be lodged instead by one of the following persons: (a) the exporter or consignor or other person in whose name or on whose behalf the carrier acts; (b) any person who is able to present the goods in question or have them presented at the customs office of exit. 3. Customs authorities may accept that commercial, port or transport information systems may be used to lodge an exit summary declaration, provided that they contain the necessary particulars for such declaration and that these particulars are available within a specific time-limit, before the goods are taken out of the customs territory of the Union. 4. Customs authorities may accept, instead of the lodging of the exit summary declaration, the lodging of a notification and access to the particulars of an exit summary declaration in the economic operator's computer system. Article 272 Amendment and invalidation of the exit summary declaration 1. The declarant may, upon application, be permitted to amend one or more particulars of the exit summary declaration after it has been lodged. No amendment shall be possible after any of the following: (a) the customs authorities have informed the person who lodged the exit summary declaration that they intend to examine the goods; (b) the customs authorities have established that one or more particulars of the exit summary declaration are inaccurate or incomplete; (c) the customs authorities have already granted the release of the goods for exit. 2. Where the goods for which an exit summary declaration has been lodged are not taken out of the customs territory of the Union, the customs authorities shall invalidate that declaration in either of the following cases: (a) upon application by the declarant; (b) within 150 days after the lodging of the declaration. Article 273 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) lodging the exit summary declaration referred to in Article 271; (b) amending the exit summary declaration, in accordance with the first subparagraph of Article 272(1); (c) invalidating the exit summary declaration, in accordance with Article 272(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 5 Re-export notification Article 274 Lodging a re-export notification 1. Where non-Union goods referred to in points (b) and (c) of Article 270(3) are taken out of the customs territory of the Union and the obligation to lodge an exit summary declaration for those goods is waived, a re-export notification shall be lodged. 2. The re-export notification shall be lodged at the customs office of exit of the goods by the person responsible for the presentation of goods on exit in accordance with Article 267(2). 3. The re-export notification shall contain the particulars necessary to discharge the free zone procedure or to end the temporary storage. Customs authorities may accept that commercial, port or transport information systems may be used to lodge a re-export notification, provided that they contain the necessary particulars for such notification and these particulars are available before the goods are taken out of the customs territory of the Union. 4. Customs authorities may accept, instead of the lodging of the re-export notification, the lodging of a notification and access to the particulars of a re-export notification in the economic operator's computer system. Article 275 Amendment and invalidation of the re-export notification 1. The declarant may, upon application, be permitted to amend one or more particulars of the re-export notification after it has been lodged. No amendment shall be possible after any of the following: (a) the customs authorities have informed the person who lodged the re-export notification that they intend to examine the goods; (b) the customs authorities have established that one or more particulars of the re-export notification are inaccurate or incomplete; (c) the customs authorities have already granted the release of the goods for exit. 2. Where the goods for which a re-export notification has been lodged are not taken out of the customs territory of the Union, the customs authorities shall invalidate that notification in either of the following cases: (a) upon application by the declarant; (b) within 150 days after the lodging of the notification. Article 276 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) lodging the re-export notification referred to in Article 274; (b) amending the re-export notification, in accordance with the first sub-paragraph of Article 275(1); (c) invalidating the re-export notification in accordance with Article 275(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 6 Relief from export duty Article 277 Relief from export duty for Union goods temporarily exported Without prejudice to Article 259, Union goods which are temporarily exported from the customs territory of the Union shall benefit from export duty relief, conditional upon their re-import. TITLE IX ELECTRONIC SYSTEMS, SIMPLIFICATIONS, DELEGATION OF POWER, COMMITTEE PROCEDURE AND FINAL PROVISIONS CHAPTER 1 Development of electronic systems Article 278 Transitional measures Means for the exchange and storage of information, other than the electronic data-processing techniques referred to in Article 6(1), may be used on a transitional basis, until 31 December 2020 at the latest, where the electronic systems which are necessary for the application of the provisions of the Code are not yet operational. Article 279 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284 specifying the rules on the exchange and storage of data in the situation referred to in Article 278. Article 280 Work programme 1. In order to support the development of the electronic systems referred to in Article 278 and govern the setting up of transitional periods, the Commission shall, by 1 May 2014, draw up a work programme relating to the development and deployment of the electronic systems referred to in Article 16(1). 2. The work programme referred to in paragraph 1 shall have the following priorities: (a) the harmonised exchange of information on the basis of internationally accepted data models and message formats; (b) the reengineering of customs and customs related processes in view of enhancing their efficiency, effectiveness and uniform application and reducing compliance costs; and (c) the offering to economic operators of a wide range of electronic customs services, enabling them to interact in the same way with the customs authorities of any Member State. 3. The work programme referred to in paragraph 1 shall be updated regularly. Article 281 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, the work programme referred to in Article 280. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Where the committee delivers no opinion, the Commission shall not adopt the implementing acts referred to in paragraph 1 and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. CHAPTER 2 Simplifications in the application of the customs legislation Article 282 Tests The Commission may authorise one or more Member States, upon application, to test for a limited period of time simplifications in the application of the customs legislation, especially when IT-related. The test shall not affect the application of the customs legislation in those Member States that are not participating in such test and shall be evaluated periodically. Article 283 Conferral of implementing powers The Commission shall adopt, by means of implementing act, the decisions referred to in Article 282. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 3 Delegation of power and committee procedure Article 284 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 2, 7, 10, 20, 24, 31, 36, 40, 62, 65, 75, 88, 99, 106, 115, 122, 126, 131, 142, 151, 156, 160, 164, 168, 175, 180, 183, 186, 196, 206, 212, 213, 221, 224, 231, 235, 253, 265, and 279 shall be conferred on the Commission for a period of five years from 30 October 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 2, 7, 10, 20, 24, 31, 36, 40, 62, 65, 75, 88, 99, 106, 115, 122, 126, 131, 142, 151, 156, 160, 164, 168, 175, 180, 183, 186, 196, 206, 212, 213, 221, 224, 231, 235, 253, 265, and 279 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 2, 7, 10, 20, 24, 31, 36, 40, 62, 65, 75, 88, 99, 106, 115, 122, 126, 131, 142, 151, 156, 160, 164, 168, 175, 180, 183, 186, 196, 206, 212, 213, 221, 224, 231, 235, 253, 265, or 279 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 285 Committee procedure 1. The Commission shall be assisted by the Customs Code Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 in conjunction with Article 4 thereof shall apply. 4. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 5. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 in conjunction with Article 5 thereof shall apply. 6. Where the opinion of the committee is to be obtained by written procedure and reference is made to this paragraph, that procedure shall be terminated without result only when, within the time-limit for delivery of the opinion, the chair of the committee so decides. CHAPTER 4 Final provisions Article 286 Repeal and amendment of legislation in force 1. Regulation (EC) No 450/2008 is repealed. 2. Regulation (EEC) No 3925/91, Regulation (EEC) No 2913/92 and Regulation (EC) No 1207/2001 are repealed from the date referred to in Article 288(2). 3. References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation tables set out in the Annex. 4. In the sixth indent of Article 3(1) of Regulation (EEC) No 2913/92, the phrase 'and Mayotte' is deleted as from 1 January 2014. 5. The first indent of point (a) of Article 9(1) of Regulation (EEC) No 2658/87 is deleted from the date referred to in Article 288(2). Article 287 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 288 Application 1. Articles 2, 7, 8, 10, 11, 17, 20, 21, 24, 25, 31, 32, 36, 37, 40, 41, 50, 52, 54, 58, 62, 63, 65, 66, 68, 75, 76, 88, 99, 100, 106, 107, 115, 122, 123, 126, 131, 132, 138, 142, 143, 151, 152, 156, 157, 160, 161, 164, 165, 168, 169, 175, 176, 178, 180, 181, 183, 184, 186, 187, 193, 196, 200, 206, 207, 209, 212, 213, 216, 217, 221, 222, 224, 225, 231, 232, 235, 236, 239, 253, 265, 266, 268, 273, 276, 279, 280, 281, 283, 284, 285 and 286 shall apply as from 30 October 2013. 2. Articles other than those referred to in paragraph 1 shall apply as from 1 June 2016. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 October 2013. For the European Parliament The President M. SCHULZ For the Council The President V. LE\u0160KEVI\u010cIUS (1) OJ C 229, 31.7.2012, p. 68. (2) Position of the European Parliament of 11 September 2013 (not yet published in the Official Journal) and decision of the Council of 27 September 2013. (3) OJ L 145, 4.6.2008, p. 1. (4) OJ L 55, 28.2.2011, p. 13. (5) OJ L 302, 19.10.1992, p. 1. (6) OJ L 117, 4.5.2005, p. 13. (7) OJ L 86, 3.4.2003, p. 21. (8) OJ L 347, 11.12.2006, p. 1. (9) OJ L 9, 14.1.2009, p. 12. (10) OJ L 23, 26.1.2008, p. 21. (11) OJ L 374, 31.12.1991, p. 4. (12) OJ L 165, 21.6.2001, p. 1. (13) OJ L 256, 7.9.1987, p. 1. (14) OJ L 124, 8.6.1971, p. 1. (15) OJ L 324, 10.12.2009, p. 23. (16) OJ L 152, 16.6.2009, p. 23 (17) OJ L 82, 22.3.1997, p. 1. ANNEX CORRELATION TABLE Regulation (EC) No 450/2008 This Regulation Article 1(1) and (2) Article 1(1) and (2) Article 1(3), first subparagraph Article 1(3) Article 1(3), second subparagraph Article 2 Article 2 Article 3 Article 3 Article 4 Article 4, points 1 to 8 Article 5, points 1 to 8 Article 4, point 9 Article 5, points 9 and 10 Article 4, point 10 Article 5, point 12 Article 4, points 11 and 12 Article 5, points 15 and 16 Article 4, points 13 to 17 Article 5, points 18 to 22 Article 4, point 18(a), first sentence Article 5, point 23(a) Article 4, point 18(a), second sentence Article 130(3) Article 4, point 18(b) and (c) Article 5, point 23(b) and (c) Article 4, points 19 to 26 Article 5, points 24 to 31 Article 4, point 27 to 32 Article 5, points 33 to 38 Article 4, point 33 \u2014 Article 5(1), first subparagraph Article 6(1) Article 5(1), second and third subparagraphs Articles 6(3) and 7(b) Article (5)(2) Articles 6(2), 7(a) and 8(1)(a) Article 6 Article 12 Article 7 Article 13 Article 8 Article 14 Article 9 Article 15 Article 10(1) Articles 9 and 16(1) Article 10(2) Articles 10, 11 and 17 Article 11(1), first and second subparagraphs Article 18 Article 11(1), third subparagraph Article 18(2), first subparagraph Article 11(2) Article 18(3) Article 11(3)(a) Article 18(2), second subparagraph and Article 21 Article 11(3)(b) Article 21 Article 11(3)(c) \u2014 Article 12(1) Article 19(1) Article 12(2), first subparagraph Article 19(2), first subparagraph Article 12(2), second subparagraph Article 19(2), second subparagraph and Article 20(b) Article 13(1) Article 38(1) Article 13(2) Article 38(2) and (3) Article 13(3) Article 38(4) Article 13(4) Article 38(5), first sentence Article 13(5) \u2014 Article 13(6) Article 23(2) Article 14 Article 39 Article 15(1)(a) Article 22, Article 24(a) to (g) and Article 25(a) and (b) Article 15(1)(b) Articles 23(4)(b) and 24(h) Article 15(1)(c) \u2014 Article 15(1)(d) Article 22(1), third subparagraph and 24(a) Article 15(1)(e) Article 40(b) Article 15(1)(f) Article 25(b) Article 15(1)(g) Articles 23(4)(b), 24(h), 24(c), 28, 31(b) and 32 Article 15(1)(h) \u2014 Article 15(2) \u2014 Article 16(1) Article 22(1), first and second subparagraphs Article 16(2) Article 22(3), first and second subparagraphs Article 16(3) Article 22(2) Article 16(4), first subparagraph Article 22(6), first subparagraph, first sentence Article 16(4), second subparagraph Article 22(6), first subparagraph, second sentence and Article 22(7) Article 16(5)(a) Article 22(6), second subparagraph and Article 24(g) Article 16(5)(b) Article 24(f) Article 16(6) Article 23(3) Article 16(7) Article 29 Article 17 Article 26 Article 18(1) to (3) Article 27 Article 18(4) Article 32 Article 19(1) Article 28(1)(a) Article 19(2) and (3) Article 28(2) and (3) Article 19(4) Article 28(4), first subparagraph and second subparagraph, first sentence Article 19(5) Article 31(a) Article 20(1) to (4) Article 33 Article 20(5) Article 34(4) Article 20(6), first subparagraph Article 34(5), first sentence Article 20(6), second subparagraph Article 34(6) Article 20(7) Articles 22, 23, 24, 25 and 32 Article 20(8)(a) Article 34(1) to (3) Article 20(8)(b) Article 34(9) and Article 37(1)(a) Article 20(8)(c) Article 34(11) and 37(2) Article 20(9) Articles 35, 36(b) and 37(1)(c) and (d) Article 21 Article 42 Article 22 Article 43 Article 23 Article 44 Article 24(1) and (2) Article 45(1) and (2) Article 24(3), first subparagraph Article 45(3) Article 24(3), second subparagraph \u2014 Article 25(1) Article 46(1) Article 25(2), first subparagraph Article 46(2) Article 25(2), second and third subparagraphs Article 46(3) Article 25(3) Article 46(4) to (8) and Article 50(1) Article 26 Article 47 Article 27 Article 48 Article 28(1) and (2) Article 49 Article 28(3) Article 50(2) Article 29 Article 51 Article 30(1) Article 52 Article 30(2) \u2014 Article 31(1) Article 53(1) Article 31(2) Article 53(3) Article 31(3) Article 54 Article 32 Article 55 Article 33(1) to (4) Article 56(1) to (4) Article 33(5) Articles 56(5) and 58(1) Article 34 Article 57(1),(2) and (3) Article 35 Article 59 Article 36 Article 60 Article 37 Article 61 Article 38 Articles 62, 63, 67 and 68 Article 39(1) and (2) Article 64(1) and (2) Article 39(3) Article 64(3), first subparagraph Article 39(4) and (5) Article 64(4) and (5) Article 39(6) Article 64(3), second subparagraph, Article 64(6) and Articles 63 to 68 Article 40 Article 69 Article 41 Article 70 Article 42(1) Article 74(1) Article 42(2) Article 74(2)(a) to (c) and the introductory sentence of point (d) Article 42(3) Article 74(3) Article 43(a) Articles 71, 72 and 76(a) Article 43(b) Article 74(2)(d), points (i), (ii) and (iii) Article 43(c) \u2014 Article 43(d) Articles 73 and 75 and Article 76(b) and (c) Article 44 Article 77 Article 45 Article 78 Article 46 Article 79 Article 47 Article 80 Article 48 Article 81 Article 49 Article 82 Article 50 Article 83 Article 51 Article 84 Article 52 Article 85 Article 53(1) to (3) Article 86(1) to (3) Article 53(4) Article 86(6) Article 54(a) and (b) Article 86(5) and Article 88(a) Article 54(c) Article 86(4) and Article 88(b) Article 55(1) Article 87(1) Article 55(2), first subparagraph Article 87(2) Article 55(2), second subparagraph Article 88(c) Article 55(3) and (4) Article 87(3) and (4) Article 56(1) to (5) Article 89(1) to (5) Article 56(6) Article 89(7) Article 56(7) Article 89(9) Article 56(8) Article 89(2), second subparagraph Article 56(9), first indent Article 100(1)(b) Article 56(9), second indent Articles 89(8) and 99(a) Article 56(9), third indent Article 89(2), second subparagraph Article 57(1) and (2) Article 90 Article 57(3) Article 100(1)(a) Article 58, first paragraph Article 91 Article 58, second paragraph \u2014 Article 59(1), first subparagraph Article 100(1) Article 59(1), second subparagraph Article 99(b) Article 59(2) Article 92(2) Article 60 Article 93 Article 61 Article 94 Article 62(1) and (2) Article 95(1) and (2) Article 62(3) Article 22, Article 24(a) to (g), Article 25(a) and (b) and Article 99(c) Article 63(1) and (2) \u2014 Article 63(3)(a) \u2014 Article 63(3)(b) Articles 96(1)(a), 96(2), 100(1)(c) and 100(2) Article 63(3)(c) Article 96(1)(b),96(2), 100(1)(c) and 100(2) Article 64 Article 97 Article 65(1) and (2) Article 98 Article 65(3) Articles 99(d) and 100(1)(b) Article 66 Article 101(1) and (2) Article 67(1), first and second subparagraphs Article 102(1) Article 67(1), third subparagraph Article 106 Article 67(2) and (3) Article 102(2) and (3), first subparagraph Article 68(1) and (2) Article 103(1) and (2) Article 68(3) Article 103(3)(a) Article 68(4) Article 103(4) Article 69 Article 104 Article 70 Article 105(1) to (5) Article 71 Article 105(6) Article 72(1) and (2) Article 108(1) and (2) Article 72(3) Articles 108(3) and 115 Article 73 Article 109 Article 74 Article 110 Article 75 Article 111 Article 76 \u2014 Article 77(1), first subparagraph Article 112(1) Article 77(1), second and third subparagraphs Article 112(2) Article 77(2) Article 112(3) Article 77(3) Article 112(4) Article 78(1), first subparagraph Article 113 Article 78(1), second subparagraph Articles 99(d) and 100(1)(b) Article 78(2) to (4) Article 114(1) to (3) Article 78(5) Article 114(4) Article 79(1) Article 116(1) Article 79(2) to (5) Article 116(4) to (7) Article 80 Article 117(1) Article 81(1) and (2) Article 118(1) and (2) Article 81(3) Article 118(4) Article 82(1) Article 119(1) Article 82(2) Article 119(3) Article 83 Article 120(1) Article 84(1) Article 121(1) Article 84(2) Article 121(3) Article 85, first sentence Articles 116(2), 117(2), 118(3), 119(2), 120(2), 121(2) and 123(1) Article 85, second sentence Articles 106(3), 122 and 123(2) Article 86(1) introductory sentence Article 124(1) introductory sentence and point (a) Article 86(1) (a) to (c) Article 124(1) (b) to (d) Article 86(1) (d) and (e) Article 124(1) (e) Article 86(1) (f) to (k) Article 124(1) (f) to (k) Article 86(2) and (3) Article 124(2) and (3) Article 86(4) to (6) Article 124(5) to (7) Article 86(7) Article 126 Article 87(1) Articles 127(1) and 127(2)(a) Article 87(2), first subparagraph Article 127(3), first subparagraph Article 87(2), second subparagraph Article 127(8) Article 87(3), first subparagraph, point (a) Articles 127(2)(b) and 131(a) Article 87(3), first subparagraph, points (b) and (c) Article 131(b) Article 87(3), first subparagraph, point (d) Articles 127(3) and 161(a) Article 87(3), second subparagraph \u2014 Article 88(1), first subparagraph, first sentence Article 6(1) Article 88(1), first subparagraph, second sentence Article 127(7) Article 88(1), second subparagraph Article 6(2) Article 88(2) Article 127(4), first subparagraph Article 88(3) Article 127(4), second subparagraph and (6) Article 88(4), first subparagraph Article 133(1), first subparagraph Article 88(4), second and third subparagraphs Articles 6(2) and 7(a) Article 89(1) Article 129(1) Article 89(2) \u2014 Article 90 Article 130(1) Article 91 Article 134 Article 92(1), first subparagraph Article 135(1) Article 92(1), second subparagraph Article 135(2) Article 92(1), third subparagraph \u2014 Article 92(2) to (5) Article 135(3) to (6) Article 93(1) Article 136 Article 93(2) \u2014 Article 94 Article 137 Article 95(1) Article 139(1) Article 95(2) and (3) Article 139(3) and (4) Article 95(4) Article 139(6) Article 96(1) and (2) Article 140 Article 96(3) Article 139(7) Article 97(1) Article 149 Article 97(2) Article 150 Article 98(1) Article 144 Article 98(2) Article 139(5) Article 99 Article 141(1) Article 100 Article 141(2) Article 101(1) Article 153(1) Article 101(2)(a) Articles 153(2) and 156(a) Article 101(2)(b) Articles 156(b) and 157 Article 101(2)(c) Articles 153(3) and 156(c) Article 102 Article 154 Article 103 Articles 155(2) and 156(d) Article 104(1) Article 158(1) Article 104(2) Article 158(3) Article 105(1) Article 159(1) and (2) Article 105(2)(a) and (b) Articles 159(3) and 161(a) Article 105(2)(c) Articles 22(1), third subparagraph, and 25(c) Article 106(1), first subparagraph, first sentence Article 179(1), first subparagraph Article 106(1), first subparagraph, second sentence \u2014 Article 106(2) Article 179(3) and (6) Article 106(3) Article 179(5) Article 106(4), first subparagraph, point (a) Article 22, Article 24(a) to (g) and Article 25(a) and (b) Article 106(4), first subparagraph, point (b) Articles 23(4)(a) and 24(h) Article 106(4), first subparagraph, point (c) Article 179(1), second subparagraph, Article 179(2) and Article 180 Article 106(4), first subparagraph, point (d) Article 22(1), third subparagraph and 24(a) Article 106(4), first subparagraph, point (e) Article 25(b) Article 106(4), first subparagraph, point (f) Articles 23(4)(b), 24(h), 28, 31(b) and 32 Article 106(4), first subparagraph, points (g) and (h) Article 181 Article 106(4), second subparagraph \u2014 Article 107(1), first sentence Article 6(1) Article 107(1), second sentence Article 182(1) Article 107(2) Article 158(2) Article 107(3) Articles 160, 161(b), 182(2) to (4), 183 and 184 Article 108(1), first subparagraph, first sentence Article 162 Article 108(1), first subparagraph, second and third sentences Article 170(4) Article 108(1), second subparagraph Articles 6(2), 7(a) and 8(1)(a) Article 108(2) Article 163(1) and (2) Article 108(3), first subparagraph Article 6(1) Article 108(3), second subparagraph \u2014 Article 108(4) Articles 163(3), 164 and 165(b) Article 109(1) Article 166(1) Article 109(2) Articles 166(2) and 168 (a) Article 109(3) Articles 6(2), 7(a), 8(1)(a) and 165(a) Article 110(1), first subparagraph Article 167(1), first subparagraph Article 110(1), second subparagraph Article 167(1), third subparagraph Article 110(1), third subparagraph Article 167(2) and (3) and Article 168(d) Article 110(2) and (3) Article 167(4) and (5) Article 111(1) Article 170(1) Article 111(2), first sentence Article 170(2) Article 111(2), second sentence Article 170(3)(a) and (b) Article 111(3) Articles 170(3)(c) Article 112(1), first subparagraph Article 172(1) Article 112(1), second subparagraph, first sentence Article 182(2) Article 112(1), second subparagraph, second sentence Article 182(3) Article 112(2) \u2014 Article 112(3) Article 172(2) Article 112(4) Articles 176(b) Article 113(1) and (2) Article 173(1) and (2) Article 113(3) Articles 173(3) and 176(c) Article 114(1) Article 174(1) Article 114(2), first subparagraph Article 174(2) Article 114(2), second subparagraph Article 175 Article 115, first paragraph Article 177(1) Article 115, second paragraph Articles 177(2) and 178 Article 116(1) Article 185(1) Article 116(2), first subparagraph, point (a) Article 22, Article 24(a) to (g) and Article 25(a) and (b) Article 116(2), first subparagraph, point (b) Articles 23(4)(a), 23(5), 24(h) and 25(c) Article 116(2), first subparagraph, points (c) and (d) Articles 185(2) and 186(a) Article 116(2), first subparagraph, point (e) Article 22(1), third subparagraph and 24(a) Article 116(2), first subparagraph, point (f) Article 25(b) Article 116(2), first subparagraph, point (g) Articles 23(4)(b), 24(h), 28, 31(b) and 32 Article 116(2), first subparagraph, points (h) and (i) Articles 186(b) and 187 Article 116(2), second subparagraph \u2014 Article 117 Article 188 Article 118 Article 189 Article 119(1) and (2) Article 190 Article 119(3) Article 193 Article 120 Article 191 Article 121 Article 192 Article 122 Article 193 Article 123(1) and (2) Article 194 Article 123(3) Article 179(4) Article 124(1) Article 195(1) Article 124(2) Article 195(2) and (3) and Article 196 Article 125 Article 197 Article 126(1) Article 198(1) Article 126(2) Article 198(2), first subparagraph, first sentence Article 127(1) Article 199 Article 127(2) Article 198(3)(d) Article 128 Article 198(2), first subparagraph, second sentence and second subparagraph, Article 198(3)(a) to (c) and Article 200 Article 129 Article 201 Article 130(1) Article 203(1), first subparagraph Article 130(2) to (5) Article 203(2) to (5) Article 131(a) \u2014 Article 131(b) Article 204 Article 132 Article 205 Article 133 Article 208(1) Article 134 Articles 202, 203(1), second subparagraph, 203(6), 206, 207 and 209 Article 135 Article 210 Article 136(1) Article 211(1) Article 136(2), first subparagraph, point (a) Article 22, Article 24(a) to (g) and Article 25(a) and (b) Article 136(2), first subparagraph, point (b) Articles 23(4)(a) and 24(h) Article 136(2), first subparagraph, point (c) Article 212(a) Article 136(2), first subparagraph, point (d) Article 22(1), third subparagraph and 24(a) Article 136(2), first subparagraph, point (e) Article 25(b) Article 136(2), first subparagraph, point (f) Articles 23(4)(b), 24(h), 28, 31(b) and 32 Article 136(2), first subparagraph, point (g) \u2014 Article 136(2), first subparagraph, point (h) \u2014 Article 136(2), second subparagraph \u2014 Article 136(3), first subparagraph, point (a) Article 211(3), first subparagraph, point (a) Article 136(3), first subparagraph, point (b) Article 211(3), first subparagraph, points (b) and (c) Article 136(3), first subparagraph, point (c) Article 211(3), first subparagraph, point (d) Article 136(3), second subparagraph Article 212(b) Article 136(4), first subparagraph Article 211(4) Article 136(4), second subparagraph Article 211(5) Article 136(4), third subparagraph Article 211(6) Article 136(4), fourth subparagraph, points (a) and (b) Article 213 Article 136(4), fourth subparagraph, point (c) Article 212(c) Article 136(5) Article 23(2) Article 137(1) Article 214(1) Article 137(2) Article 214(2) and Article 7(c) Article 138 Article 215(1) to (3) Article 139 Article 218 Article 140(1) Article 219 Article 140(2) Articles 221(a) and 222(b) Article 141 Article 220 Article 142(1), first, second and third subparagraphs Article 223(1) Article 142(1), fourth subparagraph Article 224(a) Article 142(2), first subparagraph, point (a) Article 223(2), first subparagraph, point (a) Article 142(2), first subparagraph, points (b) and (c) Article 223(2), first subparagraph, points (c) and (d) Article 142(2), second subparagraph Article 223(2), first subparagraph, point (b) and Article 224(c) Article 142(3), first subparagraph Article 223(3) Article 142(3), second subparagraph Article 224(d) Article 142(4) Article 223(4) Article 143 Articles 211(2), 216, 217, 221(b), 222(b), 224(b), 225, 228, 229, 230, 231(b), 232, 233(4), 235, 236, 243(2), 251(4), 254(2), (3), (6) and (7) and 257(4) Article 144(1) Article 226(1) Article 144(2) Articles 226(2) and 231(a) Article 144(3) Article 226(3) Article 144(4) \u2014 Article 145(1) and (2) Article 227 Article 145(3), first subparagraph Article 155(1) Article 145(3), second subparagraph Article 157 Article 146 Article 233(1) to (3) Article 147 Article 234 Article 148(1) Article 237(1) Article 148(2), first subparagraph Article 237(2) Article 148(2), second subparagraph Articles 237(3) and 239 Article 149 Article 242 Article 150(1) Article 238(1) Article 150(2)(a) \u2014 Article 150(2)(b) Article 238(2) Article 150(3) \u2014 Article 151(1), first subparagraph Article 144 Article 151(1), second subparagraph Article 145(3) Article 151(2) Article 145(5) and (11) Article 151(3) \u2014 Article 151(4) Article 147(4) Article 151(5) Article 145(1), (2), (4) and (6) to (10), Article 146, Article 147(3) and (4) and Article 148 and 151 Article 152 Article147(1) and (2) Article 153 Article 240 Article 154(1)(a) Article 237(3), first sentence Article 154(1)(b) Article 241(1) Article 154(2) Article 237(3), second sentence and Article 241(2) Article 155(1) Article 243(1) Article 155(2) and (3) Article 243(3) and (4) Article 156 Article 244 Article 157 Article 245 Article 158 Article 246 Article 159 Article 247 Article 160 Article 248 Article 161 Article 249 Article 162 Article 250 Article 163 Article 251(1) to (3) Article 164, first paragraph Article 253 Article 164, second paragraph \u2014 Article 165 Article 252 Article 166(1) Article 254(1) Article 166(2) and (3) Article 254(4) and (5) Article 167 Article 255 Article 168 Article 256 Article 169 Article 257(1) to (3) Article 170 Article 258 Article 171(1) and (2) Article 259(1) and (2) Article 171(3) Article 86(5) Article 171(4) Article 259(3) Article 172 Article 260 Article 173 Article 261 Article 174 Article 262 Article 175(1), first subparagraph Article 263(1) Article 175(1), second subparagraph Article 263(2)(a) Article 175(2) and (3) Article 263(3) and (4) Article 176(1)(a) and (b) Article 263(2)(b) and Article 265(b) Article 176(1)(c) and (d) Article 265(b) Article 176(1)(e) Article 161(a) Article 176(2) \u2014 Article 177(1) and (2) Article 267(1) and (3) Article 177(3) Article 267(2) Article 177(4) Article 267(2) Article 177(5) Article 268 Article 178(1) Article 269(1) Article 178(2)(a) Article 269(2)(a) and (b) Article 178(2)(b) Article 269(2)(d) and (e) Article 178(3) Articles 269(3) Article 179 Article 270 Article 180(1) Article 271(1), first subparagraph Article 180(2), first sentence Article 6(1) Article 180(2), second sentence Article 271(3) Article 180(3), first subparagraph Article 6(2) Article 180(3), second subparagraph Article 271(4) Article 180(4) Article 271(2) Article 181, first and second paragraphs Article 272(1) Article 181, second paragraph and third paragraph \u2014 Article 182(1) Article 277 Article 182(2) \u2014 Article 183(1) Articles 16(1) and 17 Article 183(2)(a) and (b) \u2014 Article 183(2)(c) Articles 280 and 283 Article 184 Article 285 Article 185 \u2014 Article 186 Article 286(2) and (3) Article 187 Article 287 Article 188(1) Article 288(1) Article 188(2) Article 288(2) Article 188(3) Article 288(1)", "summary": "Union Customs Code Union Customs Code SUMMARY OF: Regulation (EU) No 952/2013 \u2014 laying down the Union Customs Code WHAT IS THE AIM OF THE REGULATION? The regulation establishes the Union Customs Code (UCC), setting out the general rules and procedures applicable to goods brought into or taken out of the customs territory of the European Union, adapted to modern trade models and communication tools. KEY POINTS The UCC and the related delegated and implementing acts (adopted by the European Commission under the regulation) aim to: offer greater legal certainty and uniformity to businesses; increase clarity for customs officials throughout the EU; complete the shift by customs to a paperless and fully electronic environment; simplify customs rules and procedures and facilitate more-efficient customs transactions in line with modern-day needs; reinforce swifter customs procedures for compliant and trustworthy businesses (authorised economic operators); safeguard the financial and economic interests of the EU and of the EU Member States, as well as the safety and security of EU citizens. Amendments The regulation has been amended on a number of occasions. The amendments include: Regulation (EU) 2016/2339, providing exemptions from customs declarations for goods that have temporarily left the EU customs territory by sea or air; Regulation (EU) 2019/474, which amended the scope of the customs territory at the request of a Member State and introduced some technical amendments; Regulation (EU) 2019/632, allowing customs authorities and businesses to continue using existing IT systems or paper-based arrangements for a limited number of customs formalities until 2025 at the latest, when new or upgraded IT systems will be in place. The delegated and implementing acts have also been amended on several occasions (see consolidated versions in the section \u2018Related documents\u2019 below). Electronic customs systems Implementing Regulation (EU) 2021/414 sets out the technical arrangements for developing, maintaining and employing electronic customs systems. As of 29 March 2021, it replaced and repealed Implementing Regulation (EU) 2019/1026. It applies to: the Customs Decisions System (CDS); the Uniform User Management and Digital Signature (UUM & DS) system; the European Binding Tariff Information (EBTI) system; the Economic Operators Registration and Identification (EORI) system; the Authorised Economic Operator (AEO) system; the Import Control System 2 (ICS2); the Automated Export System (AES); the New Computerised Transit System (NCTS); the Information Sheets for Special Procedures (INF SP) system; the Centralised Clearance for Import (CCI) system. It also applies to the following electronic systems: the European Union Customs Trader Portal; the Customs Risk Management System (CRMS). FROM WHEN DOES THE REGULATION APPLY? It has applied in its entirety since 1 May 2016. Regulation (EU) No 952/2013 revised and replaced Regulation (EC) No 450/2008 and its subsequent amendments. BACKGROUND For further information: Union Customs Code (UCC) (European Commission) EU Customs facts and figures (European Commission) UCC \u2014 Legislation (European Commission). MAIN DOCUMENT Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (recast) (OJ L 269, 10.10.2013, pp. 1-101) Successive amendments to Regulation (EU) No 952/2013 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) 2021/414 of 8 March 2021 on technical arrangements for developing, maintaining and employing electronic systems for the exchange and storage of information under Regulation (EU) No 952/2013 of the European Parliament and of the Council (OJ L 81, 9.3.2021, pp. 37-64) Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee \u2014 Taking the Customs Union to the next level: a plan for action (COM(2020) 581 final, 28.9.2020) Commission staff working document \u2014 2nd Biennial Report on Progress in Developing the EU Customs Union and its Governance (SWD(2020) 213 final, 28.9.2020) Commission Implementing Decision (EU) 2019/2151 of 13 December 2019 establishing the work programme relating to the development and deployment of the electronic systems provided for in the Union Customs Code (OJ L 325, 16.12.2019, pp. 168-182) Communication from the Commission to the Council and the European Parliament \u2014 First Biennial Report on Progress in Developing the EU Customs Union and its Governance (COM(2018) 524 final, 5.7.2018) Report from the Commission to the European Parliament and the Council on the implementation of the Union Customs Code and on the exercise of the power to adopt delegated acts pursuant to Article 284 thereunder (COM(2018) 39 final, 22.1.2018) Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee \u2014 Developing the EU Customs Union and its governance (COM(2016) 813 final, 21.12.2016) Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015 supplementing Regulation (EU) No 952/2013 of the European Parliament and of the Council as regards detailed rules concerning certain provisions of the Union Customs Code (OJ L 343, 29.12.2015, pp. 1-557) See consolidated version. Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, pp. 558-893) See consolidated version. last update 17.05.2021"}
{"article": "29.6.2013 EN Official Journal of the European Union L 181/15 REGULATION (EU) No 608/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) The Council requested, in its Resolution of 25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan, that Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (2), be reviewed. (2) The marketing of goods infringing intellectual property rights does considerable damage to right-holders, users or groups of producers, and to law-abiding manufacturers and traders. Such marketing could also be deceiving consumers, and could in some cases be endangering their health and safety. Such goods should, in so far as is possible, be kept off the Union market and measures should be adopted to deal with such unlawful marketing without impeding legitimate trade. (3) The review of Regulation (EC) No 1383/2003 showed that, in the light of economic, commercial and legal developments, certain improvements to the legal framework are necessary to strengthen the enforcement of intellectual property rights by customs authorities, as well as to ensure appropriate legal certainty. (4) The customs authorities should be competent to enforce intellectual property rights with regard to goods, which, in accordance with Union customs legislation, are liable to customs supervision or customs control, and to carry out adequate controls on such goods with a view to preventing operations in breach of intellectual property rights laws. Enforcing intellectual property rights at the border, wherever the goods are, or should have been, under customs supervision or customs control is an efficient way to quickly and effectively provide legal protection to the right-holder as well as the users and groups of producers. Where the release of goods is suspended or goods are detained by customs authorities at the border, only one legal proceeding should be required, whereas several separate proceedings should be required for the same level of enforcement for goods found on the market, which have been disaggregated and delivered to retailers. An exception should be made for goods released for free circulation under the end-use regime, as such goods remain under customs supervision, even though they have been released for free circulation. This Regulation should not apply to goods carried by passengers in their personal luggage provided that those goods are for their own personal use and there are no indications that commercial traffic is involved. (5) Regulation (EC) No 1383/2003 does not cover certain intellectual property rights and certain infringements are excluded from its scope. In order to strengthen the enforcement of intellectual property rights, customs intervention should be extended to other types of infringements not covered by Regulation (EC) No 1383/2003. This Regulation should therefore, in addition to the rights already covered by Regulation (EC) No 1383/2003, also include trade names in so far as they are protected as exclusive property rights under national law, topographies of semiconductor products and utility models and devices which are primarily designed, produced or adapted for the purpose of enabling or facilitating the circumvention of technological measures. (6) Infringements resulting from so-called illegal parallel trade and overruns are excluded from the scope of Regulation (EC) No 1383/2003. Goods subject to illegal parallel trade, namely goods that have been manufactured with the consent of the right-holder but placed on the market for the first time in the European Economic Area without his consent, and overruns, namely goods that are manufactured by a person duly authorised by a right-holder to manufacture a certain quantity of goods, in excess of the quantities agreed between that person and the right-holder, are manufactured as genuine goods and it is therefore not appropriate that customs authorities focus their efforts on such goods. Illegal parallel trade and overruns should therefore also be excluded from the scope of this Regulation. (7) Member States should, in cooperation with the Commission, provide appropriate training for customs officials, in order to ensure the correct implementation of this Regulation. (8) This Regulation, when fully implemented, will further contribute to an internal market which ensures right-holders a more effective protection, fuels creativity and innovation and provides consumers with reliable and high-quality products, which should in turn strengthen cross-border transactions between consumers, businesses and traders. (9) Member States face increasingly limited resources in the field of customs. Therefore, the promotion of risk management technologies and strategies to maximise resources available to customs authorities should be supported. (10) This Regulation solely contains procedural rules for customs authorities. Accordingly, this Regulation does not set out any criteria for ascertaining the existence of an infringement of an intellectual property right. (11) Under the \u2018Declaration on the TRIPS Agreement and Public Health\u2019 adopted by the Doha WTO Ministerial Conference on 14 November 2001, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) can and should be interpreted and implemented in a manner supportive of WTO Members\u2019 right to protect public health and, in particular, to promote access to medicines for all. Consequently, in line with the Union\u2019s international commitments and its development cooperation policy, with regard to medicines, the passage of which across the customs territory of the Union, with or without transhipment, warehousing, breaking bulk, or changes in the mode or means of transport, is only a portion of a complete journey beginning and terminating beyond the territory of the Union, customs authorities should, when assessing a risk of infringement of intellectual property rights, take account of any substantial likelihood of diversion of such medicines onto the market of the Union. (12) This Regulation should not affect the provisions on the competence of courts, in particular, those of Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (3). (13) Persons, users, bodies or groups of producers, who are in a position to initiate legal proceedings in their own name with respect to a possible infringement of an intellectual property right, should be entitled to submit an application. (14) In order to ensure that intellectual property rights are enforced throughout the Union, it is appropriate to allow persons or entities seeking enforcement of Union-wide rights to apply to the customs authorities of a single Member State. Such applicants should be able to request that those authorities decide that action be taken to enforce the intellectual property right both in their own Member State and in any other Member State. (15) In order to ensure the swift enforcement of intellectual property rights, it should be provided that, where the customs authorities suspect, on the basis of reasonable indications, that goods under their supervision infringe intellectual property rights, they may suspend the release of or detain the goods whether at their own initiative or upon application, in order to enable a person or entity entitled to submit an application to initiate proceedings for determining whether an intellectual property right has been infringed. (16) Regulation (EC) No 1383/2003 allowed Member States to provide for a procedure allowing the destruction of certain goods without there being any obligation to initiate proceedings to establish whether an intellectual property right has been infringed. As recognised in the European Parliament Resolution of 18 December 2008 on the impact of counterfeiting on international trade (4), such procedure has proved very successful in the Member States where it has been available. Therefore, the procedure should be made compulsory with regard to all infringements of intellectual property rights and should be applied, where the declarant or the holder of the goods agrees to destruction. Furthermore, the procedure should provide that customs authorities may deem that the declarant or the holder of the goods has agreed to the destruction of the goods where he has not explicitly opposed destruction within the prescribed period. (17) In order to reduce the administrative burden and costs to a minimum, a specific procedure should be introduced for small consignments of counterfeit and pirated goods, which should allow for such goods to be destroyed without the explicit agreement of the applicant in each case. However, a general request made by the applicant in the application should be required in order for that procedure to be applied. Furthermore, customs authorities should have the possibility to require that the applicant covers the costs incurred by the application of that procedure. (18) For further legal certainty, it is appropriate to modify the timelines for suspending the release of or detaining goods suspected of infringing an intellectual property right and the conditions in which information about detained goods is to be passed on to persons and entities concerned by customs authorities, as provided for in Regulation (EC) No 1383/2003. (19) Taking into account the provisional and preventive character of the measures adopted by the customs authorities when applying this Regulation and the conflicting interests of the parties affected by the measures, some aspects of the procedures should be adapted to ensure the smooth application of this Regulation, whilst respecting the rights of the concerned parties. Thus, with respect to the various notifications envisaged by this Regulation, the customs authorities should notify the relevant person, on the basis of the documents concerning the customs treatment or of the situation in which the goods are placed. Furthermore, since the procedure for destruction of goods implies that both the declarant or the holder of the goods and the holder of the decision should communicate their possible objections to destruction in parallel, it should be ensured that the holder of the decision is given the possibility to react to a potential objection to destruction by the declarant or the holder of the goods. It should therefore be ensured that the declarant or the holder of the goods is notified of the suspension of the release of the goods or their detention before, or on the same day as, the holder of the decision. (20) Customs authorities and the Commission are encouraged to cooperate with the European Observatory on Infringements of Intellectual Property Rights in the framework of their respective competences. (21) With a view to eliminating international trade in goods infringing intellectual property rights, the TRIPS Agreement provides that WTO Members are to promote the exchange of information between customs authorities on such trade. Accordingly, it should be possible for the Commission and the customs authorities of the Member States to share information on suspected breaches of intellectual property rights with the relevant authorities of third countries, including on goods which are in transit through the territory of the Union and originate in or are destined for those third countries. (22) In the interest of efficiency, the provisions of Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs or agricultural matters (5), should apply. (23) The liability of the customs authorities should be governed by the legislation of the Member States, though the granting by the customs authorities of an application should not entitle the holder of the decision to compensation in the event that goods suspected of infringing an intellectual property right are not detected by the customs authorities and are released or no action is taken to detain them. (24) Given that customs authorities take action upon application, it is appropriate to provide that the holder of the decision should reimburse all the costs incurred by the customs authorities in taking action to enforce his intellectual property rights. Nevertheless, this should not preclude the holder of the decision from seeking compensation from the infringer or other persons that might be considered liable under the legislation of the Member State where the goods were found. Such persons might include intermediaries, where applicable. Costs and damages incurred by persons other than customs authorities as a result of a customs action, where the release of goods is suspended or the goods are detained on the basis of a claim of a third party based on intellectual property, should be governed by the specific legislation applicable in each particular case. (25) This Regulation introduces the possibility for customs authorities to allow goods which are to be destroyed to be moved, under customs supervision, between different places within the customs territory of the Union. Customs authorities may furthermore decide to release such goods for free circulation with a view to further recycling or disposal outside commercial channels including for awareness-raising, training and educational purposes. (26) Customs enforcement of intellectual property rights entails the exchange of data on decisions relating to applications. Such processing of data covers also personal data and should be carried out in accordance with Union law, as set out in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (6) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by Community institutions and bodies and on the free movement of such data (7). (27) The exchange of information relating to decisions on applications and to customs actions should be made via a central electronic database. The entity which will control and manage that database and the entities in charge of ensuring the security of the processing of the data contained in the database should be defined. Introducing any type of possible interoperability or exchange should first and foremost comply with the purpose limitation principle, namely that data should be used for the purpose for which the database has been established, and no further exchange or interconnection should be allowed other than for that purpose. (28) In order to ensure that the definition of small consignments can be adapted if it proves to be impractical, taking into account the need to ensure the effective operation of the procedure, or where necessary to avoid any circumvention of this procedure as regards the composition of consignments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the non-essential elements of the definition of small consignments, namely the specific quantities set out in that definition. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (29) In order to ensure uniform conditions for the implementation of the provisions concerning defining the elements of the practical arrangements for the exchange of data with third countries and the provisions concerning the forms for the application and for requesting the extension of the period during which customs authorities are to take action, implementing powers should be conferred on the Commission, namely to define those elements of the practical arrangements and to establish standard forms. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (8). For establishing the standard forms, although the subject of the provisions of this Regulation to be implemented falls within the scope of the common commercial policy, given the nature and impacts of those implementing acts, the advisory procedure should be used for their adoption, because all details of what information to include in the forms follows directly from the text of this Regulation. Those implementing acts will therefore only establish the format and structure of the form and will have no further implications for the common commercial policy of the Union. (30) Regulation (EC) No 1383/2003 should be repealed. (31) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 12 October 2011 (9), HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter and scope 1. This Regulation sets out the conditions and procedures for action by the customs authorities where goods suspected of infringing an intellectual property right are, or should have been, subject to customs supervision or customs control within the customs territory of the Union in accordance with Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (10), particularly goods in the following situations: (a) when declared for release for free circulation, export or re-export; (b) when entering or leaving the customs territory of the Union; (c) when placed under a suspensive procedure or in a free zone or free warehouse. 2. In respect of the goods subject to customs supervision or customs control, and without prejudice to Articles 17 and 18, the customs authorities shall carry out adequate customs controls and shall take proportionate identification measures as provided for in Article 13(1) and Article 72 of Regulation (EEC) No 2913/92 in accordance with risk analysis criteria with a view to preventing acts in breach of intellectual property laws applicable in the territory of the Union and in order to cooperate with third countries on the enforcement of intellectual property rights. 3. This Regulation shall not apply to goods that have been released for free circulation under the end-use regime. 4. This Regulation shall not apply to goods of a non-commercial nature contained in travellers\u2019 personal luggage. 5. This Regulation shall not apply to goods that have been manufactured with the consent of the right-holder or to goods manufactured, by a person duly authorised by a right-holder to manufacture a certain quantity of goods, in excess of the quantities agreed between that person and the right-holder. 6. This Regulation shall not affect national or Union law on intellectual property or the laws of the Member States in relation to criminal procedures. Article 2 Definitions For the purposes of this Regulation: (1) \u2018intellectual property right\u2019 means: (a) a trade mark; (b) a design; (c) a copyright or any related right as provided for by national or Union law; (d) a geographical indication; (e) a patent as provided for by national or Union law; (f) a supplementary protection certificate for medicinal products as provided for in Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (11); (g) a supplementary protection certificate for plant protection products as provided for in Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (12); (h) a Community plant variety right as provided for in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (13); (i) a plant variety right as provided for by national law; (j) a topography of semiconductor product as provided for by national or Union law; (k) a utility model in so far as it is protected as an intellectual property right by national or Union law; (l) a trade name in so far as it is protected as an exclusive intellectual property right by national or Union law; (2) \u2018trade mark\u2019 means: (a) a Community trade mark as provided for in Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (14); (b) a trade mark registered in a Member State, or, in the case of Belgium, Luxembourg or the Netherlands, at the Benelux Office for Intellectual Property; (c) a trade mark registered under international arrangements which has effect in a Member State or in the Union; (3) \u2018design\u2019 means: (a) a Community design as provided for in Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (15); (b) a design registered in a Member State, or, in the case of Belgium, Luxembourg or the Netherlands, at the Benelux Office for Intellectual Property; (c) a design registered under international arrangements which has effect in a Member State or in the Union; (4) \u2018geographical indication\u2019 means: (a) a geographical indication or designation of origin protected for agricultural products and foodstuff as provided for in Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (16); (b) a designation of origin or geographical indication for wine as provided for in Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (17); (c) a geographical designation for aromatised drinks based on wine products as provided for in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine-based drinks and aromatized wine-product cocktails (18); (d) a geographical indication of spirit drinks as provided for in Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks (19); (e) a geographical indication for products not falling under points (a) to (d) in so far as it is established as an exclusive intellectual property right by national or Union law; (f) a geographical indication as provided for in Agreements between the Union and third countries and as such listed in those Agreements; (5) \u2018counterfeit goods\u2019 means: (a) goods which are the subject of an act infringing a trade mark in the Member State where they are found and bear without authorisation a sign which is identical to the trade mark validly registered in respect of the same type of goods, or which cannot be distinguished in its essential aspects from such a trade mark; (b) goods which are the subject of an act infringing a geographical indication in the Member State where they are found and, bear or are described by, a name or term protected in respect of that geographical indication; (c) any packaging, label, sticker, brochure, operating instructions, warranty document or other similar item, even if presented separately, which is the subject of an act infringing a trade mark or a geographical indication, which includes a sign, name or term which is identical to a validly registered trade mark or protected geographical indication, or which cannot be distinguished in its essential aspects from such a trade mark or geographical indication, and which can be used for the same type of goods as that for which the trade mark or geographical indication has been registered; (6) \u2018pirated goods\u2019 means goods which are the subject of an act infringing a copyright or related right or a design in the Member State where the goods are found and which are, or contain copies, made without the consent of the holder of a copyright or related right or a design, or of a person authorised by that holder in the country of production; (7) \u2018goods suspected of infringing an intellectual property right\u2019 means goods with regard to which there are reasonable indications that, in the Member State where those goods are found, they are prima facie: (a) goods which are the subject of an act infringing an intellectual property right in that Member State; (b) devices, products or components which are primarily designed, produced or adapted for the purpose of enabling or facilitating the circumvention of any technology, device or component that, in the normal course of its operation, prevents or restricts acts in respect of works which are not authorised by the holder of any copyright or any right related to copyright and which relate to an act infringing those rights in that Member State; (c) any mould or matrix which is specifically designed or adapted for the manufacture of goods infringing an intellectual property right, if such moulds or matrices relate to an act infringing an intellectual property right in that Member State; (8) \u2018right-holder\u2019 means the holder of an intellectual property right; (9) \u2018application\u2019 means a request made to the competent customs department for customs authorities to take action with respect to goods suspected of infringing an intellectual property right; (10) \u2018national application\u2019 means an application requesting the customs authorities of a Member State to take action in that Member State; (11) \u2018Union application\u2019 means an application submitted in one Member State and requesting the customs authorities of that Member State and of one or more other Member States to take action in their respective Member States; (12) \u2018applicant\u2019 means the person or entity in whose name an application is submitted; (13) \u2018holder of the decision\u2019 means the holder of a decision granting an application; (14) \u2018holder of the goods\u2019 means the person who is the owner of the goods suspected of infringing an intellectual property right or who has a similar right of disposal, or physical control, over such goods; (15) \u2018declarant\u2019 means the declarant as defined in point (18) of Article 4 of Regulation (EEC) No 2913/92; (16) \u2018destruction\u2019 means the physical destruction, recycling or disposal of goods outside commercial channels, in such a way as to preclude damage to the holder of the decision; (17) \u2018customs territory of the Union\u2019 means the customs territory of the Community as defined in Article 3 of Regulation (EEC) No 2913/92; (18) \u2018release of the goods\u2019 means the release of the goods as defined in point (20) of Article 4 of Regulation (EEC) No 2913/92; (19) \u2018small consignment\u2019 means a postal or express courier consignment, which: (a) contains three units or less; or (b) has a gross weight of less than two kilograms. For the purpose of point (a), \u2018units\u2019 means goods as classified under the Combined Nomenclature in accordance with Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (20) if unpackaged, or the package of such goods intended for retail sale to the ultimate consumer. For the purpose of this definition, separate goods falling in the same Combined Nomenclature code shall be considered as different units and goods presented as sets classified in one Combined Nomenclature code shall be considered as one unit; (20) \u2018perishable goods\u2019 means goods considered by customs authorities to deteriorate by being kept for up to 20 days from the date of their suspension of release or detention; (21) \u2018exclusive licence\u2019 means a licence (whether general or limited) authorising the licensee to the exclusion of all other persons, including the person granting the licence, to use an intellectual property right in the manner authorised by the licence. CHAPTER II APPLICATIONS SECTION 1 Submission of applications Article 3 Entitlement to submit an application The following persons and entities shall, to the extent they are entitled to initiate proceedings, in order to determine whether an intellectual property right has been infringed, in the Member State or Member States where the customs authorities are requested to take action, be entitled to submit: (1) a national or a Union application: (a) right-holders; (b) intellectual property collective rights management bodies as referred to in point (c) of Article 4(1) of Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (21); (c) professional defence bodies as referred to in point (d) of Article 4(1) of Directive 2004/48/EC; (d) groups within the meaning of point (2) of Article 3, and Article 49(1) of Regulation (EU) No 1151/2012, groups of producers within the meaning of Article 118e of Regulation (EC) No 1234/2007 or similar groups of producers provided for in Union law governing geographical indications representing producers of products with a geographical indication or representatives of such groups, in particular Regulations (EEC) No 1601/91 and (EC) No 110/2008 and operators entitled to use a geographical indication as well as inspection bodies or authorities competent for such a geographical indication; (2) a national application: (a) persons or entities authorised to use intellectual property rights, which have been authorised formally by the right-holder to initiate proceedings in order to determine whether the intellectual property right has been infringed; (b) groups of producers provided for in the legislation of the Member States governing geographical indications representing producers of products with geographical indications or representatives of such groups and operators entitled to use a geographical indication, as well as inspection bodies or authorities competent for such a geographical indication; (3) a Union application: holders of exclusive licenses covering the entire territory of two or more Member States, where those licence holders have been authorised formally in those Member States by the right-holder to initiate proceedings in order to determine whether the intellectual property right has been infringed. Article 4 Intellectual property rights covered by Union applications A Union application may be submitted only with respect to intellectual property rights based on Union law producing effects throughout the Union. Article 5 Submission of applications 1. Each Member State shall designate the customs department competent to receive and process applications (\u2018competent customs department\u2019). The Member State shall inform the Commission accordingly and the Commission shall make public a list of competent customs departments designated by the Member States. 2. Applications shall be submitted to the competent customs department. The applications shall be completed using the form referred to in Article 6 and shall contain the information required therein. 3. Where an application is submitted after notification by the customs authorities of the suspension of the release or detention of the goods in accordance with Article 18(3), that application shall comply with the following: (a) it is submitted to the competent customs department within four working days of the notification of the suspension of the release or detention of the goods; (b) it is a national application; (c) it contains the information referred to in Article 6(3). The applicant may, however, omit the information referred to in point (g), (h) or (i) of that paragraph. 4. Except in the circumstances referred to in point (3) of Article 3, only one national application and one Union application may be submitted per Member State for the same intellectual property right protected in that Member State. In the circumstances referred to in point (3) of Article 3, more than one Union application shall be allowed. 5. Where a Union application is granted for a Member State already covered by another Union application granted to the same applicant and for the same intellectual property right, the customs authorities of that Member State shall take action on the basis of the Union application first granted. They shall inform the competent customs department of the Member State where any subsequent Union application was granted, which shall, amend or revoke the decision granting that subsequent Union application. 6. Where computerised systems are available for the purpose of receiving and processing applications, applications as well as attachments shall be submitted using electronic data-processing techniques. Member States and the Commission shall develop, maintain and employ such systems in accordance with the multi-annual strategic plan referred to in Article 8(2) of Decision No 70/2008/EC of the European Parliament and of the Council of 15 January 2008 on a paperless customs environment for customs and trade (22). Article 6 Application form 1. The Commission shall establish an application form by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 34(2). 2. The application form shall specify the information that has to be provided to the data subject pursuant to Regulation (EC) No 45/2001 and national laws implementing Directive 95/46/EC. 3. The Commission shall ensure that the following information is required of the applicant in the application form: (a) details concerning the applicant; (b) the status, within the meaning of Article 3, of the applicant; (c) documents providing evidence to satisfy the competent customs department that the applicant is entitled to submit the application; (d) where the applicant submits the application by means of a representative, details of the person representing him and evidence of that person\u2019s powers to act as representative, in accordance with the legislation of the Member State in which the application is submitted; (e) the intellectual property right or rights to be enforced; (f) in the case of a Union application, the Member States in which customs action is requested; (g) specific and technical data on the authentic goods, including markings such as bar-coding and images where appropriate; (h) the information needed to enable the customs authorities to readily identify the goods in question; (i) information relevant to the customs authorities\u2019 analysis and assessment of the risk of infringement of the intellectual property right or the intellectual property rights concerned, such as the authorised distributors; (j) whether information provided in accordance with point (g), (h) or (i) of this paragraph is to be marked for restricted handling in accordance with Article 31(5); (k) the details of any representative designated by the applicant to take charge of legal and technical matters; (l) an undertaking by the applicant to notify the competent customs department of any of the situations laid down in Article 15; (m) an undertaking by the applicant to forward and update any information relevant to the customs authorities\u2019 analysis and assessment of the risk of infringement of the intellectual property right(s) concerned; (n) an undertaking by the applicant to assume liability under the conditions laid down in Article 28; (o) an undertaking by the applicant to bear the costs referred to in Article 29 under the conditions laid down in that Article; (p) an agreement by the applicant that the data provided by him may be processed by the Commission and by the Member States; (q) whether the applicant requests the use of the procedure referred to in Article 26 and, where requested by the customs authorities, agrees to cover the costs related to destruction of goods under that procedure. SECTION 2 Decisions on applications Article 7 Processing of incomplete applications 1. Where, on receipt of an application, the competent customs department considers that the application does not contain all the information required by Article 6(3), the competent customs department shall request the applicant to supply the missing information within 10 working days of notification of the request. In such cases, the time-limit referred to in Article 9(1) shall be suspended until the relevant information is received. 2. Where the applicant does not provide the missing information within the period referred to in the first subparagraph of paragraph 1, the competent customs department shall reject the application. Article 8 Fees The applicant shall not be charged a fee to cover the administrative costs resulting from the processing of the application. Article 9 Notification of decisions granting or rejecting applications 1. The competent customs department shall notify the applicant of its decision granting or rejecting the application within 30 working days of the receipt of the application. In the event of rejection, the competent customs department shall provide reasons for its decision and include information on the appeal procedure. 2. If the applicant has been notified of the suspension of the release or the detention of the goods by the customs authorities before the submission of an application, the competent customs department shall notify the applicant of its decision granting or rejecting the application within two working days of the receipt of the application. Article 10 Decisions concerning applications 1. A decision granting a national application and any decision revoking or amending it shall take effect in the Member State in which the national application was submitted from the day following the date of adoption. A decision extending the period during which customs authorities are to take action shall take effect in the Member State in which the national application was submitted on the day following the date of expiry of the period to be extended. 2. A decision granting a Union application and any decision revoking or amending it shall take effect as follows: (a) in the Member State in which the application was submitted, on the day following the date of adoption; (b) in all other Member States where action by the customs authorities is requested, on the day following the date on which the customs authorities are notified in accordance with Article 14(2), provided that the holder of the decision has fulfilled his obligations under Article 29(3) with regard to translation costs. A decision extending the period during which customs authorities are to take action shall take effect in the Member State in which the Union application was submitted and in all other Member States where action by the customs authorities is requested the day following the date of expiry of the period to be extended. Article 11 Period during which the customs authorities are to take action 1. When granting an application, the competent customs department shall specify the period during which the customs authorities are to take action. That period shall begin on the day the decision granting the application takes effect, pursuant to Article 10, and shall not exceed one year from the day following the date of adoption. 2. Where an application submitted after notification by the customs authorities of the suspension of the release or detention of the goods in accordance with Article 18(3) does not contain the information referred to in point (g), (h) or (i) of Article 6(3), it shall be granted only for the suspension of the release or detention of those goods, unless that information is provided within 10 working days after the notification of the suspension of the release or detention of the goods. 3. Where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be entitled to submit an application, no action shall be taken by the customs authorities. The decision granting the application shall be revoked or amended accordingly by the competent customs department that granted the decision. Article 12 Extension of the period during which the customs authorities are to take action 1. On expiry of the period during which the customs authorities are to take action, and subject to the prior discharge by the holder of the decision of any debt owed to the customs authorities under this Regulation, the competent customs department which adopted the initial decision may, at the request of the holder of the decision, extend that period. 2. Where the request for extension of the period during which the customs authorities are to take action is received by the competent customs department less than 30 working days before the expiry of the period to be extended, it may refuse that request. 3. The competent customs department shall notify its decision on the extension to the holder of the decision within 30 working days of the receipt of the request referred to in paragraph 1. The competent customs department shall specify the period during which the customs authorities are to take action. 4. The extended period during which the customs authorities are to take action shall run from the day following the date of expiry of the previous period and shall not exceed one year. 5. Where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be entitled to submit an application, no action shall be taken by the customs authorities. The decision granting the extension shall be revoked or amended accordingly by the competent customs department that granted the decision. 6. The holder of the decision shall not be charged a fee to cover the administrative costs resulting from the processing of the request for extension. 7. The Commission shall establish an extension request form by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 34(2). Article 13 Amending the decision with regard to intellectual property rights. The competent customs department that adopted the decision granting the application may, at the request of the holder of that decision, modify the list of intellectual property rights in that decision. Where a new intellectual property right is added, the request shall contain the information referred to in points (c), (e), (g), (h) and (i) of Article 6(3). In the case of a decision granting a Union application, any modification consisting of the addition of intellectual property rights shall be limited to intellectual property rights covered by Article 4. Article 14 Notification obligations of the competent customs department 1. The competent customs department to which a national application has been submitted shall forward the following decisions to the customs offices of its Member State, immediately after their adoption: (a) decisions granting the application; (b) decisions revoking decisions granting the application; (c) decisions amending decisions granting the application; (d) decisions extending the period during which the customs authorities are to take action. 2. The competent customs department to which a Union application has been submitted shall forward the following decisions to the competent customs department of the Member State or Member States indicated in the Union application, immediately after their adoption: (a) decisions granting the application; (b) decisions revoking decisions granting the application; (c) decisions amending decisions granting the application; (d) decisions extending the period during which the customs authorities are to take action. The competent customs department of the Member State or Member States indicated in the Union application shall immediately after receiving those decisions forward them to their customs offices. 3. The competent customs department of the Member State or Member States indicated in the Union application may request the competent customs department that adopted the decision granting the application to provide them with additional information deemed necessary for the implementation of that decision. 4. The competent customs department shall forward its decision suspending the actions of the customs authorities under point (b) of Article 16(1) and Article 16(2) to the customs offices of its Member State, immediately after its adoption. Article 15 Notification obligations of the holder of the decision The holder of the decision shall immediately notify the competent customs department that granted the application of any of the following: (a) an intellectual property right covered by the application ceases to have effect; (b) the holder of the decision ceases for other reasons to be entitled to submit the application; (c) modifications to the information referred to in Article 6(3). Article 16 Failure of the holder of the decision to fulfil his obligations 1. Where the holder of the decision uses the information provided by the customs authorities for purposes other than those provided for in Article 21, the competent customs department of the Member State where the information was provided or misused may: (a) revoke any decision adopted by it granting a national application to that holder of the decision, and refuse to extend the period during which the customs authorities are to take action; (b) suspend in their territory, during the period during which the customs authorities are to take action, any decision granting a Union application to that holder of the decision. 2. The competent customs department may decide to suspend the actions of the customs authorities until the expiry of the period during which those authorities are to take action, where the holder of the decision: (a) does not fulfil the notification obligations set out in Article 15; (b) does not fulfil the obligation on returning samples set out in Article 19(3); (c) does not fulfil the obligations on costs and translation set out in Article 29(1) and (3); (d) without valid reason does not initiate proceedings as provided for in Article 23(3) or Article 26(9). In the case of a Union application, the decision to suspend the actions of the customs authorities shall have effect only in the Member State where such decision is taken. CHAPTER III ACTION BY THE CUSTOMS AUTHORITIES SECTION 1 Suspension of the release or detention of goods suspected of infringing an intellectual property right Article 17 Suspension of the release or detention of the goods following the grant of an application 1. Where the customs authorities identify goods suspected of infringing an intellectual property right covered by a decision granting an application, they shall suspend the release of the goods or detain them. 2. Before suspending the release of or detaining the goods, the customs authorities may ask the holder of the decision to provide them with any relevant information with respect to the goods. The customs authorities may also provide the holder of the decision with information about the actual or estimated quantity of goods, their actual or presumed nature and images thereof, as appropriate. 3. The customs authorities shall notify the declarant or the holder of the goods of the suspension of the release of the goods or the detention of the goods within one working day of that suspension or detention. Where the customs authorities opt to notify the holder of the goods and two or more persons are considered to be the holder of the goods, the customs authorities shall not be obliged to notify more than one of those persons. The customs authorities shall notify the holder of the decision of the suspension of the release of the goods or the detention on the same day as, or promptly after, the declarant or the holder of the goods is notified. The notifications shall include information on the procedure set out in Article 23. 4. The customs authorities shall inform the holder of the decision and the declarant or the holder of the goods of the actual or estimated quantity and the actual or presumed nature of the goods, including available images thereof, as appropriate, whose release has been suspended or which have been detained. The customs authorities shall also, upon request and where available to them, inform the holder of the decision of the names and addresses of the consignee, the consignor and the declarant or the holder of the goods, of the customs procedure and of the origin, provenance and destination of the goods whose release has been suspended or which have been detained. Article 18 Suspension of the release or detention of the goods before the grant of an application 1. Where the customs authorities identify goods suspected of infringing an intellectual property right, which are not covered by a decision granting an application, they may, except for in the case of perishable goods, suspend the release of those goods or detain them. 2. Before suspending the release of or detaining the goods suspected of infringing an intellectual property right, the customs authorities may, without disclosing any information other than the actual or estimated quantity of goods, their actual or presumed nature and images thereof, as appropriate, request any person or entity potentially entitled to submit an application concerning the alleged infringement of the intellectual property rights to provide them with any relevant information. 3. The customs authorities shall notify the declarant or the holder of the goods of the suspension of the release of the goods or their detention within one working day of that suspension or detention. Where the customs authorities opt to notify the holder of the goods and two or more persons are considered to be the holder of the goods, the customs authorities shall not be obliged to notify more than one of those persons. The customs authorities shall notify persons or entities entitled to submit an application concerning the alleged infringement of the intellectual property rights, of the suspension of the release of the goods or their detention on the same day as, or promptly after, the declarant or the holder of the goods is notified. The customs authorities may consult the competent public authorities in order to identify the persons or entities entitled to submit an application. The notifications shall include information on the procedure set out in Article 23. 4. The customs authorities shall grant the release of the goods or put an end to their detention immediately after completion of all customs formalities in the following cases: (a) where they have not identified any person or entity entitled to submit an application concerning the alleged infringement of intellectual property rights within one working day from the suspension of the release or the detention of the goods; (b) where they have not received an application in accordance with Article 5(3), or where they have rejected such an application. 5. Where an application has been granted, the customs authorities shall, upon request and where available to them, inform the holder of the decision of the names and addresses of the consignee, the consignor and the declarant or the holder of the goods, of the customs procedure and of the origin, provenance and destination of the goods whose release has been suspended or which have been detained. Article 19 Inspection and sampling of goods whose release has been suspended or which have been detained 1. The customs authorities shall give the holder of the decision and the declarant or the holder of the goods the opportunity to inspect the goods whose release has been suspended or which have been detained. 2. The customs authorities may take samples that are representative of the goods. They may provide or send such samples to the holder of the decision, at the holder\u2019s request and strictly for the purposes of analysis and to facilitate the subsequent procedure in relation to counterfeit and pirated goods. Any analysis of those samples shall be carried out under the sole responsibility of the holder of the decision. 3. The holder of the decision shall, unless circumstances do not allow, return the samples referred to in paragraph 2 to the customs authorities on completion of the analysis, at the latest before the goods are released or their detention is ended. Article 20 Conditions for storage The conditions of storage of goods during a period of suspension of release or detention shall be determined by the customs authorities. Article 21 Permitted use of certain information by the holder of the decision Where the holder of the decision has received the information referred to in Article 17(4), Article 18(5), Article 19 or Article 26(8), he may disclose or use that information only for the following purposes: (a) to initiate proceedings to determine whether an intellectual property right has been infringed and in the course of such proceedings; (b) in connection with criminal investigations related to the infringement of an intellectual property right and undertaken by public authorities in the Member State where the goods are found; (c) to initiate criminal proceedings and in the course of such proceedings; (d) to seek compensation from the infringer or other persons; (e) to agree with the declarant or the holder of the goods that the goods be destroyed in accordance with Article 23(1); (f) to agree with the declarant or the holder of the goods of the amount of the guarantee referred to in point (a) of Article 24(2). Article 22 Sharing of information and data between customs authorities 1. Without prejudice to applicable provisions on data protection in the Union and for the purpose of contributing to eliminating international trade in goods infringing intellectual property rights, the Commission and the customs authorities of the Member States may share certain data and information available to them with the relevant authorities in third countries according to the practical arrangements referred to in paragraph 3. 2. The data and information referred to in paragraph 1 shall be exchanged to swiftly enable effective enforcement against shipments of goods infringing an intellectual property right. Such data and information may relate to seizures, trends and general risk information, including on goods which are in transit through the territory of the Union and which have originated in or are destined for the territory of third countries concerned. Such data and information may include, where appropriate, the following: (a) nature and quantity of goods; (b) suspected intellectual property right infringed; (c) origin, provenance and destination of the goods; (d) information on movements of means of transport, in particular: (i) name of vessel or registration of means of transport; (ii) reference numbers of freight bill or other transport document; (iii) number of containers; (iv) weight of load; (v) description and/or coding of goods; (vi) reservation number; (vii) seal number; (viii) place of first loading; (ix) place of final unloading; (x) places of transhipment; (xi) expected date of arrival at place of final unloading; (e) information on movements of containers, in particular: (i) container number; (ii) container loading status; (iii) date of movement; (iv) type of movement (loaded, unloaded, transhipped, entered, left, etc.); (v) name of vessel or registration of means of transport; (vi) number of voyage/journey; (vii) place; (viii) freight bill or other transport document. 3. The Commission shall adopt implementing acts defining the elements of the necessary practical arrangements concerning the exchange of data and information referred to in paragraphs 1 and 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). SECTION 2 Destruction of goods, initiation of proceedings and early release of goods Article 23 Destruction of goods and initiation of proceedings 1. Goods suspected of infringing an intellectual property right may be destroyed under customs control, without there being any need to determine whether an intellectual property right has been infringed under the law of the Member State where the goods are found, where all of the following conditions are fulfilled: (a) the holder of the decision has confirmed in writing to the customs authorities, within 10 working days, or three working days in the case of perishable goods, of notification of the suspension of the release or the detention of the goods, that, in his conviction, an intellectual property right has been infringed; (b) the holder of the decision has confirmed in writing to the customs authorities, within 10 working days, or three working days in the case of perishable goods, of notification of the suspension of the release or the detention of the goods, his agreement to the destruction of the goods; (c) the declarant or the holder of the goods has confirmed in writing to the customs authorities, within 10 working days, or three working days in the case of perishable goods, of notification of the suspension of the release or the detention of the goods, his agreement to the destruction of the goods. Where the declarant or the holder of the goods has not confirmed his agreement to the destruction of the goods nor notified his opposition thereto to the customs authorities, within those deadlines, the customs authorities may deem the declarant or the holder of the goods to have confirmed his agreement to the destruction of those goods. The customs authorities shall grant the release of the goods or put an end to their detention, immediately after completion of all customs formalities, where within the periods referred to in points (a) and (b) of the first subparagraph, they have not received both the written confirmation from the holder of the decision that, in his conviction, an intellectual property right has been infringed and his agreement to destruction, unless those authorities have been duly informed about the initiation of proceedings to determine whether an intellectual property right has been infringed. 2. The destruction of the goods shall be carried out under customs control and under the responsibility of the holder of the decision, unless otherwise specified in the national law of the Member State where the goods are destroyed. Samples may be taken by competent authorities prior to the destruction of the goods. Samples taken prior to destruction may be used for educational purposes. 3. Where the declarant or the holder of the goods has not confirmed his agreement to the destruction in writing and where the declarant or the holder of the goods has not been deemed to have confirmed his agreement to the destruction, in accordance with point (c) of the first subparagraph of paragraph 1 within the periods referred to therein, the customs authorities shall immediately notify the holder of the decision thereof. The holder of the decision shall, within 10 working days, or three working days in the case of perishable goods, of notification of the suspension of the release or the detention of the goods, initiate proceedings to determine whether an intellectual property right has been infringed. 4. Except in the case of perishable goods the customs authorities may extend the period referred to in paragraph 3 by a maximum of 10 working days upon a duly justified request by the holder of the decision in appropriate cases. 5. The customs authorities shall grant the release of the goods or put an end to their detention, immediately after completion of all customs formalities, where, within the periods referred to in paragraphs 3 and 4, they have not been duly informed, in accordance with paragraph 3, on the initiation of proceedings to determine whether an intellectual property right has been infringed. Article 24 Early release of goods 1. Where the customs authorities have been notified of the initiation of proceedings to determine whether a design, patent, utility model, topography of semiconductor product or plant variety has been infringed, the declarant or the holder of the goods may request the customs authorities to release the goods or put an end to their detention before the completion of those proceedings. 2. The customs authorities shall release the goods or put an end to their detention only where all the following conditions are fulfilled: (a) the declarant or the holder of the goods has provided a guarantee that is of an amount sufficient to protect the interests of the holder of the decision; (b) the authority competent to determine whether an intellectual property right has been infringed has not authorised precautionary measures; (c) all customs formalities have been completed. 3. The provision of the guarantee referred to in point (a) of paragraph 2 shall not affect the other legal remedies available to the holder of the decision. Article 25 Goods for destruction 1. Goods to be destroyed under Article 23 or 26 shall not be: (a) released for free circulation, unless customs authorities, with the agreement of the holder of the decision, decide that it is necessary in the event that the goods are to be recycled or disposed of outside commercial channels, including for awareness-raising, training and educational purposes. The conditions under which the goods can be released for free circulation shall be determined by the customs authorities; (b) brought out of the customs territory of the Union; (c) exported; (d) re-exported; (e) placed under a suspensive procedure; (f) placed in a free zone or free warehouse. 2. The customs authorities may allow the goods referred to in paragraph 1 to be moved under customs supervision between different places within the customs territory of the Union with a view to their destruction under customs control. Article 26 Procedure for the destruction of goods in small consignments 1. This Article shall apply to goods where all of the following conditions are fulfilled: (a) the goods are suspected of being counterfeit or pirated goods; (b) the goods are not perishable goods; (c) the goods are covered by a decision granting an application; (d) the holder of the decision has requested the use of the procedure set out in this Article in the application; (e) the goods are transported in small consignments. 2. When the procedure set out in this Article is applied, Article 17(3) and (4) and Article 19(2) and (3) shall not apply. 3. The customs authorities shall notify the declarant or the holder of the goods of the suspension of the release of the goods or their detention within one working day of the suspension of the release or of the detention of the goods. The notification of the suspension of the release or the detention of the goods shall include the following information: (a) that the customs authorities intend to destroy the goods; (b) the rights of the declarant or the holder of the goods under paragraphs 4, 5 and 6. 4. The declarant or the holder of the goods shall be given the opportunity to express his point of view within 10 working days of notification of the suspension of the release or the detention of the goods. 5. The goods concerned may be destroyed where, within 10 working days of notification of the suspension of the release or the detention of the goods, the declarant or the holder of the goods has confirmed to the customs authorities his agreement to the destruction of the goods. 6. Where the declarant or the holder of the goods has not confirmed his agreement to the destruction of the goods nor notified his opposition thereto to the customs authorities, within the period referred to in paragraph 5, the customs authorities may deem the declarant or the holder of the goods to have confirmed his agreement to the destruction of the goods. 7. The destruction shall be carried out under customs control. The customs authorities shall, upon request and as appropriate, provide the holder of the decision with information about the actual or estimated quantity of destroyed goods and their nature. 8. Where the declarant or the holder of the goods has not confirmed his agreement to the destruction of the goods and where the declarant or the holder of the goods has not been deemed to have confirmed such agreement, in accordance with paragraph 6, the customs authorities shall immediately notify the holder of the decision thereof and of the quantity of goods and their nature, including images thereof, where appropriate. The customs authorities shall also, upon request and where available to them, inform the holder of the decision of the names and addresses of the consignee, the consignor and the declarant or the holder of the goods, of the customs procedure and of the origin, provenance and destination of the goods whose release has been suspended or which have been detained. 9. The customs authorities shall grant the release of the goods or put an end to their detention immediately after completion of all customs formalities where they have not received information from the holder of the decision on the initiation of proceedings to determine whether an intellectual property right has been infringed within 10 working days of the notification referred to in paragraph 8. 10. The Commission shall be empowered to adopt delegated acts in accordance with Article 35 concerning the amendment of quantities in the definition of small consignments in the event that the definition is found to be impractical in the light of the need to ensure the effective operation of the procedure set out in this Article, or where necessary in order to avoid any circumvention of this procedure as regards the composition of consignments. CHAPTER IV LIABILITY, COSTS AND PENALTIES Article 27 Liability of the customs authorities Without prejudice to national law, the decision granting an application shall not entitle the holder of that decision to compensation in the event that goods suspected of infringing an intellectual property right are not detected by a customs office and are released, or no action is taken to detain them. Article 28 Liability of the holder of the decision Where a procedure duly initiated pursuant to this Regulation is discontinued owing to an act or omission on the part of the holder of the decision, where samples taken pursuant to Article 19(2) are either not returned or are damaged and beyond use owing to an act or omission on the part of the holder of the decision, or where the goods in question are subsequently found not to infringe an intellectual property right, the holder of the decision shall be liable towards any holder of the goods or declarant, who has suffered damage in that regard, in accordance with specific applicable legislation. Article 29 Costs 1. Where requested by the customs authorities, the holder of the decision shall reimburse the costs incurred by the customs authorities, or other parties acting on behalf of customs authorities, from the moment of detention or suspension of the release of the goods, including storage and handling of the goods, in accordance with Article 17(1), Article 18(1) and Article 19(2) and (3), and when using corrective measures such as destruction of goods in accordance with Articles 23 and 26. The holder of a decision to whom the suspension of release or detention of goods has been notified shall, upon request, be given information by the customs authorities on where and how those goods are being stored and on the estimated costs of storage referred to in this paragraph. The information on estimated costs may be expressed in terms of time, products, volume, weight or service depending on the circumstances of storage and the nature of the goods. 2. This Article shall be without prejudice to the right of the holder of the decision to seek compensation from the infringer or other persons in accordance with the legislation applicable. 3. The holder of a decision granting a Union application shall provide and pay for any translation required by the competent customs department or customs authorities which are to take action concerning the goods suspected of infringing an intellectual property right. Article 30 Penalties The Member States shall ensure that the holders of decisions comply with the obligations set out in this Regulation, including, where appropriate, by laying down provisions establishing penalties. The penalties provided for shall be effective, proportionate and dissuasive. The Member States shall notify those provisions and any subsequent amendment affecting them to the Commission without delay. CHAPTER V EXCHANGE OF INFORMATION Article 31 Exchange of data on decisions relating to applications and detentions between the Member States and the Commission 1. The competent customs departments shall notify without delay the Commission of the following: (a) decisions granting applications, including the application and its attachments; (b) decisions extending the period during which the customs authorities are to take action or decisions revoking the decision granting the application or amending it; (c) the suspension of a decision granting the application. 2. Without prejudice to point (g) of Article 24 of Regulation (EC) No 515/97, where the release of the goods is suspended or the goods are detained, the customs authorities shall transmit to the Commission any relevant information, except personal data, including information on the quantity and type of the goods, value, intellectual property rights, customs procedures, countries of provenance, origin and destination, and transport routes and means. 3. The transmission of the information referred to in paragraphs 1 and 2 of this Article and all exchanges of data on decisions concerning applications as referred to in Article 14 between customs authorities of the Member States shall be made via a central database of the Commission. The information and data shall be stored in that database. 4. For the purposes of ensuring processing of the information referred to in paragraphs 1 to 3 of this Article, the central database referred to in paragraph 3 shall be established in an electronic form. The central database shall contain the information, including personal data, referred to in Article 6(3), Article 14 and this Article. 5. The customs authorities of the Member States and the Commission shall have access to the information contained in the central database as appropriate for the fulfilment of their legal responsibilities in applying this Regulation. The access to information marked for restricted handling in accordance with Article 6(3) is restricted to the customs authorities of the Member States where action is requested. Upon justified request by the Commission, the customs authorities of the Member States may give access to the Commission to such information where it is strictly necessary for the application of this Regulation. 6. The customs authorities shall introduce into the central database information related to the applications submitted to the competent customs department. The customs authorities which have introduced information into the central database shall, where necessary, amend, supplement, correct or delete such information. Each customs authority that has introduced information in the central database shall be responsible for the accuracy, adequacy and relevancy of this information. 7. The Commission shall establish and maintain adequate technical and organisational arrangements for the reliable and secure operation of the central database. The customs authorities of each Member State shall establish and maintain adequate technical and organisational arrangements to ensure the confidentiality and security of processing with respect to the processing operations carried out by their customs authorities and with respect to terminals of the central database located on the territory of that Member State. Article 32 Establishment of a central database The Commission shall establish the central database referred to in Article 31. That database shall be operational as soon as possible and not later than 1 January 2015. Article 33 Data protection provisions 1. The processing of personal data in the central database of the Commission shall be carried out in accordance with Regulation (EC) No 45/2001 and under the supervision of the European Data Protection Supervisor. 2. Processing of personal data by the competent authorities in the Member States shall be carried out in accordance with Directive 95/46/EC and under the supervision of the public independent authority of the Member State referred to in Article 28 of that Directive. 3. Personal data shall be collected and used solely for the purposes of this Regulation. Personal data so collected shall be accurate and shall be kept up to date. 4. Each customs authority that has introduced personal data into the central database shall be the controller with respect to the processing of this data. 5. A data subject shall have a right of access to the personal data relating to him or her that are processed through the central database and, where appropriate, the right to the rectification, erasure or blocking of personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC. 6. All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the customs authorities. Where a data subject has submitted a request for the exercise of that right to the Commission, the Commission shall forward such request to the customs authorities concerned. 7. Personal data shall not be kept longer than six months from the date the relevant decision granting the application has been revoked or the relevant period during which the customs authorities are to take action has expired. 8. Where the holder of the decision has initiated proceedings in accordance with Article 23(3) or Article 26(9) and has notified the customs authorities of the initiation of such proceedings, personal data shall be kept for six months after proceedings have determined in a final way whether an intellectual property right has been infringed. CHAPTER VI COMMITTEE, DELEGATION AND FINAL PROVISIONS Article 34 Committee procedure 1. The Commission shall be assisted by the Customs Code Committee established by Articles 247a and 248a of Regulation (EEC) No 2913/92. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 35 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 26(10) shall be conferred on the Commission for an indeterminate period of time from 19 July 2013. 3. The delegation of power referred to in Article 26(10) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 26(10) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months on the initiative of the European Parliament or of the Council. Article 36 Mutual administrative assistance The provisions of Regulation (EC) No 515/97 shall apply mutatis mutandis to this Regulation. Article 37 Reporting By 31 December 2016, the Commission shall submit to the European Parliament and to the Council a report on the implementation of this Regulation. If necessary, that report shall be accompanied by appropriate recommendations. That report shall refer to any relevant incidents concerning medicines in transit across the customs territory of the Union that might occur under this Regulation, including an assessment of its potential impact on the Union commitments on access to medicines under the \u2018Declaration on the TRIPS Agreement and Public Health\u2019 adopted by the Doha WTO Ministerial Conference on 14 November 2001, and the measures taken to address any situation creating adverse effects in that regard. Article 38 Repeal Regulation (EC) No 1383/2003 is repealed with effect from 1 January 2014. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in the Annex. Article 39 Transitional provisions Applications granted in accordance with Regulation (EC) No 1383/2003 shall remain valid for the period specified in the decision granting the application during which the customs authorities are to take action and shall not be extended. Article 40 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 1 January 2014, with the exception of: (a) Article 6, Article 12(7) and Article 22(3), which shall apply from 19 July 2013; (b) Article 31(1) and (3) to (7) and Article 33, which shall apply from the date on which the central database referred to in Article 32 is in place. The Commission shall make that date public. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 12 June 2013. For the European Parliament The President M. SCHULZ For the Council The President L. CREIGHTON (1) Position of the European Parliament of 3 July 2012 (not yet published in the Official Journal) and position of the Council at first reading of 16 May 2013 (not yet published in the Official Journal). Position of the European Parliament of 11 June 2013 (not yet published in the Official Journal). (2) OJ L 196, 2.8.2003, p. 7. (3) OJ L 351, 20.12.2012, p. 1. (4) OJ C 45 E, 23.2.2010, p. 47. (5) OJ L 82, 22.3.1997, p. 1. (6) OJ L 281, 23.11.1995, p. 31. (7) OJ L 8, 12.1.2001, p. 1. (8) OJ L 55, 28.2.2011, p. 13. (9) OJ C 363, 13.12.2011, p. 3. (10) OJ L 302, 19.10.1992, p. 1. (11) OJ L 152, 16.6.2009, p. 1. (12) OJ L 198, 8.8.1996, p. 30. (13) OJ L 227, 1.9.1994, p. 1. (14) OJ L 78, 24.3.2009, p. 1. (15) OJ L 3, 5.1.2002, p. 1. (16) OJ L 343, 14.12.2012, p. 1. (17) OJ L 299, 16.11.2007, p. 1. (18) OJ L 149, 14.6.1991, p. 1. (19) OJ L 39, 13.2.2008, p. 16. (20) OJ L 256, 7.9.1987, p. 1. (21) OJ L 157, 30.4.2004, p. 45. (22) OJ L 23, 26.1.2008, p. 21. ANNEX Correlation table Regulation (EC) No 1383/2003 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 Article 1 Article 4 Article 18 Article 5 Articles 3 to 9 Article 6 Articles 6 and 29 Article 7 Article 12 Article 8 Articles 10, 11, 12, 14 and 15 Article 9 Articles 17 and 19 Article 10 \u2014 Article 11 Article 23 Article 12 Articles 16 and 21 Article 13 Article 23 Article 14 Article 24 Article 15 Article 20 Article 16 Article 25 Article 17 \u2014 Article 18 Article 30 Article 19 Articles 27 and 28 Article 20 Articles 6, 12, 22 and 26 Article 21 Article 34 Article 22 Articles 31 and 36 Article 23 \u2014 Article 24 Article 38 Article 25 Article 40", "summary": "Intellectual property rights \u2014 customs enforcement Intellectual property rights \u2014 customs enforcement SUMMARY OF: Regulation (EU) No 608/2013 on customs enforcement of intellectual property rights WHAT IS THE AIM OF THE REGULATION? The regulation provides revised procedural rules for customs authorities to enforce intellectual property rights (IPR) on goods liable to customs supervision or customs control. It replaces Regulation (EC) No 1383/2003. KEY POINTS This regulation particularly covers goods in the following situations: when declared for release for free circulation, export or re-export; when entering or leaving the customs territory of the EU; when the goods are suspended from customs clearance or are in a free zone or free warehouse*. It sets out procedures for applications to determine whether an IPR has been infringed. For the purposes of the regulation, an IPR could include: a trade mark; a design; a copyright under national or EU law; a geographical indication (such as Champagne or Parma ham); a patent under national or EU law; a supplementary protection certificate for medicinal products; a supplementary protection certificate for pesticides; an plant variety right under national or EU law; a semiconductor product design under national or EU law; an IPR that protects inventions under national or EU law; a trade name protected as an exclusive IPR under national or EU law. The regulation: sets out the conditions for customs action where goods are merely suspected of infringing IPRs; sets out measures to be taken against goods that have been found to infringe IPRs; expands the range of IPR infringements covered and reinforces the competence of customs authorities to control all goods under customs supervision \u2014 this does not apply to non-commercial goods in travellers\u2019 personal luggage; ensures that high-quality information is provided to customs to enable a comprehensive assessment of the risk of IPR infringement; sets out the legal basis for a central database for recording the applications for customs action and detentions of IPR-infringing goods as well as the exchange of information between customs authorities. To reduce administrative burden, the regulation: sets out a common procedure for all kinds of IPR infringements falling within the scope of the regulation, under which goods may be destroyed without the need for the rightsholder to initiate legal proceedings, on condition that: the rightsholder confirms in writing that in their conviction there is an infringement and that they agree to their destruction, andthe declarant or holder of the goods does not object to destruction; states that the procedure for small consignments applies only on prior request from the applicant and that the customs authorities may require the applicant to cover the costs \u2014 a small consignment is defined as a postal or express courier consignment, which either contains three units or fewer or weighs less than 2 kg. In addition, the regulation: stipulates that national laws apply when granting the right to be heard of the persons concerned by the detention of goods; broadens and clarifies the cases where the rightsholder may use the information that customs disclose following a detention of goods; includes rules on data collection, processing, data retention periods and the exercise of rights and responsibilities in relation to existing legislation on data protection. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014, with some exceptions. BACKGROUND A Commission notice relates to the trade mark package adopted in 2015: Part 1: although Regulation (EU) 2015/2424 amended Council Regulation (EC) No 207/2009 (as cited in the Commission notice), the latter was subsequently repealed and replaced by Regulation (EU) 2017/1001 \u2014 which is a codification; Part 2: relates to Directive (EU) 2015/2436 See also: \u2018Enforcement of intellectual property rights\u2019 (European Commission) \u2018Counterfeit, piracy and other IPR violations\u2019 (European Commission). KEY TERMS Free zone or warehouse: special area or warehouse within the customs territory of the EU which is exempt from custom duties. For more information, please check the relevant list. MAIN DOCUMENT Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, pp. 15-34) RELATED DOCUMENTS Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (codification) (OJ L 154, 16.6.2017, pp. 1-99) Commission notice on the customs enforcement of Intellectual Property Rights concerning goods brought into the customs territory of the Union without being released for free circulation including goods in transit (OJ C 244, 5.7.2016, pp. 4-9) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (general data protection regulation) (OJ L 119, 4.5.2016, pp. 1-88) Successive amendments to Regulation (EU) No 2016/679 have been incorporated into the original text. This consolidated version is of documentary value only. Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (recast) (OJ L 336, 23.12.2015, pp. 1-26) See consolidated version. Council resolution of 25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan (OJ C 253, 4.10.2008, pp. 1-2) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, pp. 45-86). Text republished in corrigendum (OJ L 195, 2.6.2004, pp. 16-25) See consolidated version. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 A single market for intellectual property rights: boosting creativity and innovation to provide economic growth, high-quality jobs and first-class products and services in Europe (COM(2011) 287 final, 24.5.2011) last update 08.12.2017"}
{"article": "15.3.2021 EN Official Journal of the European Union L 87/1 REGULATION (EU) 2021/444 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2021 establishing the Customs programme for cooperation in the field of customs and repealing Regulation (EU) No 1294/2013 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33, 114, and 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Customs 2020 programme set up under Regulation (EU) No 1294/2013 (3) and its predecessor programmes have significantly contributed to facilitating and enhancing customs cooperation between customs authorities, as well as to building their administrative, human and information technology (IT) capacity. Since many of the activities of the customs authorities are of a cross-border nature, a more effective and efficient way of developing such cooperation is to offer Member States a framework within which it can take place by establishing a customs programme at Union level, implemented by the Commission. Moreover, the Customs 2020 programme has proved to be cost-efficient and has added real value to other customs cooperation frameworks set up on a bilateral or multilateral basis. In addition, the Customs 2020 programme has contributed to safeguarding the financial interests of the Union and of the Member States by supporting the effective collection of customs duties. Furthermore, harmonised customs procedures are important to achieve equivalent results in the prevention of fraud and of illegal cross-border flows of goods. It is therefore appropriate, efficient and in the interest of the Union to continue financing activities in the field of customs cooperation by establishing a new programme, the Customs programme (\u2018the Programme\u2019). (2) For 50 years, the customs union has been one of the cornerstones of the Union, which is one of the largest trading blocks in the world. The customs union is a significant example of successful Union integration, and is essential for the proper functioning of the internal market for the benefit of both businesses and citizens. The customs union has evolved considerably over this period and customs authorities are successfully carrying out a wide range of tasks at the borders. Working together, they strive to facilitate legitimate and fair trade, reduce bureaucracy, collect revenue for national and Union budgets, and help to protect the citizens against terrorist, health, environmental and other threats. In particular, by introducing a common risk management framework at Union level and by controlling cash flows to combat money laundering and terrorist financing, the customs authorities play an important role in the fight against terrorism, organised crime and unfair competition. Given their extensive mandate, the customs authorities are effectively the leading authorities for the control of goods at the Union\u2019s external borders. A stronger and a more ambitious Union can only be achieved if the necessary resources are available. In that context, the Programme should not only cover customs cooperation, but should also provide support for the wider mission of customs authorities, as provided for in Article 3 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (4), namely the supervision of the Union\u2019s international trade, thereby contributing to the implementation of the external aspects of the internal market, of the common commercial policy and of the other common Union policies having a bearing on trade, and to overall supply chain security. The legal basis of this Regulation should therefore cover customs cooperation as provided for in Article 33 of the Treaty on the Functioning of the European Union (TFEU), the internal market, as provided for in Article 114 TFEU and the common commercial policy, as provided for in Article 207 TFEU. (3) The Programme should assist the Member States and the Commission by providing a framework for actions that aim to support the customs union and the customs authorities working together and acting as one; to contribute to protecting the financial and economic interests of the Union and its Member States; to ensure the security and safety of the Union and its residents, thereby contributing to consumer protection; to protect the Union from unfair and illicit commercial practices, while facilitating legitimate business activity; and to facilitate legitimate trade so that businesses and citizens can benefit from the full potential of the internal market and world trade. (4) Customs is a dynamic policy area facing new challenges, such as globalisation, new patterns in fraud and smuggling, and digitalisation. These challenges increase the demand for support to customs authorities and call for innovative solutions. They further underline the need to reinforce cooperation between customs authorities. (5) In order to ensure cost-effectiveness, the Programme should exploit possible synergies with other Union measures in related fields, such as the Fiscalis programme, which is to be established by a Regulation of the European Parliament and of the Council establishing the \u2018Fiscalis\u2019 programme for cooperation in the field of taxation, the instrument for financial support for customs control equipment, which is to be established by a Regulation of the European Parliament and of the Council establishing, as part of the Integrated Border Management Fund, the instrument for financial support for customs control equipment (the \u2018Customs Control Equipment Instrument Regulation\u2019), the Union Anti-Fraud Programme, which is to be established by a Regulation of the European Parliament and of the Council establishing the Union Anti-Fraud Programme, the instrument for financial support for border management and visa, which is to be established by a Regulation of the European Parliament and of the Council establishing, as part of the Integrated Border Management Fund, the instrument for financial support for border management and visa (BMVI), the Internal Security Fund, which is to be established by a Regulation of the European Parliament and of the Council establishing the Internal Security Fund, the Single Market Programme, which is to be established by a Regulation of the European Parliament and of the Council establishing the Programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme), the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (5) and the Technical Support Instrument established by Regulation (EU) 2021/240 of the European Parliament and of the Council (6). (6) In view of the importance of tackling climate change, and in line with the Union\u2019s commitments to implement the Paris Agreement (7) and to achieve the United Nations Sustainable Development Goals of the 2030 Agenda for Sustainable Development adopted on 25 September 2015, the actions under this Regulation should contribute to the achievement of the Union\u2019s goal of spending at least 30 % of the total amount of Union budget on supporting climate objectives and of the Union\u2019s ambition to spend 7,5 % of the annual Union budget, on biodiversity in 2024 and 10 % in both 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. (7) This Regulation lays down a financial envelope for the Programme, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (8), for the European Parliament and the Council during the annual budgetary procedure. To be considered eligible for funding, any unforeseen expenditure should be directly related to the objectives of the Programme. The financial envelope of the Programme should cover necessary and duly justified expenses for managing the Programme and evaluating its performance, provided that those activities are related to the general and specific objectives of the Programme. (8) In order to support the process of accession and association by third countries, the Programme should, if certain conditions are fulfilled, be open to the participation of acceding countries, candidate countries, potential candidates and countries covered by the European Neighbourhood Policy. It might also be open to other third countries, in accordance with the conditions laid down in specific agreements between the Union and those countries covering their participation in any Union programme. (9) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (9) (the \u2018Financial Regulation\u2019) applies to the Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (10) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (11) The actions which applied under the Customs 2020 programme have proved to be adequate and should therefore be maintained. In order to provide greater simplicity and flexibility in the execution of the Programme and thereby better deliver on its objectives, the actions should be defined only in terms of overall categories with a list of illustrative examples of concrete activities. Through cooperation and capacity building, the Programme should also promote and support the uptake and leverage of innovation to further improve the capabilities to deliver on core customs priorities. Actions financed by this Programme should be terminated or adjusted in order to make them more effective or relevant if they prove to be inadequate at any point in time. (12) The Customs Control Equipment Instrument Regulation will be soon adopted. In order to preserve the coherence and horizontal coordination of all cooperation actions relating to customs and customs control equipment, it is appropriate to implement all such actions under a single legal act, namely, this Regulation, containing a single set of rules. Therefore, the instrument for financial support for customs control equipment should support only the purchase, maintenance and upgrade of the eligible customs control equipment, while this Programme should support all other related actions, such as cooperation actions for the assessment of equipment needs or, where appropriate, training in relation to the equipment purchased. (13) The exchange of customs information and other related information is key for the proper functioning of customs and goes well beyond the exchanges within the customs union. Adaptations of, or extensions to, the European electronic systems to enable cooperation with third countries that are not participating in the Programme and with international organisations could be of interest to the Union. Therefore, when duly justified by such an interest, the corresponding adaptations or extensions to the European electronic systems should be eligible for funding under the Programme. (14) Considering the importance of globalisation, the Programme should continue to provide for the possibility of involving external experts within the meaning of Article 238 of the Financial Regulation. Such external experts should mainly include representatives of governmental authorities, including governmental authorities of third countries that are not participating in the Programme, as well as academics and representatives of international organisations, of economic operators or of civil society. The selection of external experts for expert groups should be based on Commission Decision of 30 May 2016 establishing horizontal rules on the creation and operation of Commission expert groups. External experts participating in their personal capacity in ad hoc events under the Programme, such as one-off meetings and conferences, should be selected by the Commission, including from experts proposed by the participating countries. It is necessary to ensure that external experts who are appointed in their personal capacity and required to act independently and in the public interest act impartially and that there is no possible conflict of interest with their professional responsibilities. Information about the selection of all external experts and their participation should be publicly available. The objective of ensuring a balanced representation of stakeholders and the principle of gender equality should be taken into account when selecting external experts. (15) In accordance with the Commission\u2019s commitment to ensure the coherence and simplification of funding programmes, set out in its Communication of 19 October 2010 entitled \u2018The EU Budget Review\u2019, resources should be shared with other Union funding instruments if the actions envisaged under the Programme pursue objectives that are common to various funding instruments, provided that this does not result in double financing. Actions under the Programme should ensure coherence in the use of the Union\u2019s resources supporting the customs union and customs authorities. (16) IT capacity-building actions are expected to attract the greatest share of the budget under the Programme. Among those IT capacity-building actions, top priority should be given to those actions related to electronic systems that are necessary for the implementation of the customs union and for customs authorities to carry out their mission. The common and national components of the European electronic systems should be defined in this Regulation. Combinations of common and national components are possible. Moreover, the scope of actions and the responsibilities of the Commission and the Member States should be clearly defined. (17) This Regulation should be implemented by means of work programmes. In view of the mid- to long-term nature of the objectives pursued and building on experience gained over time, it should be possible for work programmes to cover several years. A shift from annual to multiannual work programmes would reduce the administrative burden for both the Commission and the Member States. Multiannual work programmes should be for a maximum of three years. (18) The actions implemented under the Programme should take into account the findings and recommendations of the European Court of Auditors in the field of customs, in particular the special report No 19/2017 of 5 December 2017 entitled \u2018Import procedures: shortcomings in the legal framework and an ineffective implementation impact the financial interests of the EU\u2019, and the special report No 26/2018 of 10 October 2018 entitled \u2018A series of delays in Customs IT systems: what went wrong?\u2019. (19) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (10). (20) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (11), the Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating, in a comparable and complete manner, the effects of the Programme on the ground. The interim and final evaluations, which should be performed no later than four years after the start of the implementation and the completion of the Programme, respectively, should contribute to the efficient decision-making process concerning cooperation in the field of customs under the next multiannual financial frameworks. It is therefore of the utmost importance that the interim and final evaluations include satisfactory and sufficient information and that those evaluations are delivered in due time. In addition to the interim and final evaluations of the Programme, annual progress reports should, as part of the performance reporting system, be issued to monitor the implementation of the Programme. Those reports should include a summary of the lessons learnt and, where appropriate, of the obstacles and shortfalls encountered, in the context of the activities of the Programme that took place in the year in question. Those annual progress reports should be communicated to the European Parliament and to the Council. (21) In order to respond appropriately to changes in policy priorities, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the list of indicators to measure the achievement of the specific objectives of the Programme and in respect of supplementing this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (22) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (12) and Council Regulations (EC, Euratom) No 2988/95 (13), (Euratom, EC) No 2185/96 (14) and (EU) 2017/1939 (15), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (16). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors, and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (23) Third countries may participate in the Programme on the basis of a decision adopted pursuant to an international agreement or on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. (24) The eligible costs should be determined by reference to the nature of the eligible actions and including, inter alia, travel and subsistence costs for participants to meetings and similar events or costs linked to the organisation of events. Funding under the Programme should be subject to the principles referred to in the Financial Regulation, such as equal treatment, proportionality, transparency and should ensure the optimal use of its financial resources in achieving its objectives. (25) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver the intended results, taking into account, in particular, the costs of controls, the administrative burden and the expected risk of non-compliance. Those types of financing and methods of implementation should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (26) Since the objective of this Regulation, namely the establishment of a Union programme for cooperation in the field of customs, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (27) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the multi-annual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021. (28) This Regulation replaces Regulation (EU) No 1294/2013, which should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the Customs programme for cooperation in the field of customs (the \u2018Programme\u2019) for the period from 1 January 2021 to 31 December 2027. The duration of the Programme shall be aligned to the duration of the multiannual financial framework. This Regulation lays down the objectives of the Programme, the budget for the period 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018customs authorities\u2019 means the customs authorities as defined in point (1) of Article 5 of Regulation (EU) No 952/2013; (2) \u2018European electronic systems\u2019 means electronic systems necessary for the customs union and for the execution of the mission of customs authorities, in particular the electronic systems referred to in Article 16(1) and Articles 278 and 280 of Regulation (EU) No 952/2013, Article 8 of Regulation (EU) 2019/880 of the European Parliament and of the Council (17), and in other provisions of Union law governing electronic systems for customs purposes, including international agreements, such as the Customs Convention on the international transport of goods under cover of TIR carnets (TIR Convention) (18); (3) \u2018common component\u2019 means a component of the European electronic systems, developed at Union level, which is available for all Member States or identified as common by the Commission for reasons of efficiency, security and rationalisation; (4) \u2018national component\u2019 means a component of the European electronic systems, developed at national level, which is available in the Member State that created that component or contributed to its joint creation; (5) \u2018third country\u2019 means a country that is not a Member State of the Union. Article 3 Programme objectives 1. The general objective of the Programme is to support the customs union and customs authorities working together and acting as one to protect the financial and economic interests of the Union and its Member States, to ensure security and safety within the Union and to protect the Union from unfair and illegal trade, while facilitating legitimate business activity. 2. The specific objectives of the Programme are to support: (a) the preparation and uniform implementation of customs legislation and policy; (b) customs cooperation; (c) administrative and IT capacity building, including human competency and training, as well as the development and operation of European electronic systems; (d) innovation in the area of customs policy. Article 4 Budget 1. The financial envelope for the implementation of the Programme for the period 2021\u20132027 shall be EUR 950 000 000 in current prices. 2. The amount referred to in paragraph 1 may also cover expenses for preparation, monitoring, control, audit, evaluation and other activities for managing the Programme and evaluating the achievement of its objectives. It may also cover expenses linked to studies, meetings of experts, information and communication actions that are related to the objectives of the Programme, as well as expenses linked to information technology networks focusing on information processing and exchange, including corporate information technology tools and other technical and administrative assistance needed in connection with the management of the Programme. Article 5 Participation of third countries in the Programme The Programme shall be open to the participation of the following third countries: (a) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (b) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country any decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. The contributions referred to in point (c)(ii) of the first paragraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. Article 6 Implementation and forms of Union funding 1. The Programme shall be implemented under direct management in accordance with the Financial Regulation. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular by means of grants, prizes, procurement and the reimbursement of travel and subsistence expenses incurred by external experts. CHAPTER II ELIGIBILITY Article 7 Eligible actions 1. Only actions implementing the objectives set out in Article 3 shall be eligible for funding. 2. Actions complementing or supporting the actions implementing the objectives set out in the Customs Control Equipment Instrument Regulation shall also be eligible for funding under the Programme. 3. The actions referred to in paragraphs 1 and 2 shall include the following: (a) meetings and similar ad hoc events; (b) project-based structured collaboration, such as collaborative IT development by a group of Member States; (c) IT capacity-building actions, in particular the development and operation of European electronic systems; (d) human-competency and other capacity-building actions, including training and exchange of best practices; (e) support actions and other actions, including: (i) studies; (ii) innovation activities, in particular proof-of-concepts, pilot projects, prototyping initiatives, smart data mining and collaboration among systems; (iii) jointly developed communication actions; (iv) any other actions provided for in the work programmes referred to in Article 12, which are necessary for attaining, or are in support of, the objectives set out in Article 3. Annex I contains a non-exhaustive list of possible forms of actions as referred to in points (a), (b) and (d) of the first subparagraph. 4. Actions consisting in the development, deployment, maintenance and operation of adaptations of or extensions to the common components of the European electronic systems to enable cooperation with third countries that are not participating in the Programme or with international organisations shall be eligible for funding when they are of interest to the Union. The Commission shall put in place the necessary administrative arrangements, which may include a requirement for the third parties concerned to contribute financially to those actions. 5. Where an IT capacity-building action as referred to in point (c) of the first subparagraph of paragraph 3 of this Article concerns the development and operation of a European electronic system, only the costs related to the responsibilities conferred on the Commission pursuant to Article 11(2) shall be eligible for funding under the Programme. Member States shall bear the costs related to the responsibilities conferred on them pursuant to Article 11(3). Article 8 External experts 1. Where beneficial for the completion of an action implementing the objectives set out in Article 3, representatives of governmental authorities, including those from third countries that are not participating in the Programme, academics and representatives of international and other relevant organisations, representatives of economic operators, representatives of organisations representing economic operators and representatives of civil society may take part as external experts in such action. 2. Costs incurred by the external experts referred to in paragraph 1 of this Article shall be eligible for reimbursement under the Programme in accordance with Article 238 of the Financial Regulation. 3. External experts for expert groups shall be selected by the Commission, including from experts proposed by the Member States. External experts participating in their personal capacity in ad hoc events under the Programme, such as one-off meetings and conferences, shall be selected by the Commission, including from experts proposed by participating countries. External experts shall be selected on the basis of their skills, experience and knowledge relevant to the specific action and according to needs. The Commission shall assess, inter alia, the impartiality of external experts who are appointed in their personal capacity and required to act independently and in the public interest, and the absence of conflicts of interest with their professional responsibilities. CHAPTER III GRANTS Article 9 Award, complementarity and combined funding 1. Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation. 2. An action that has received a contribution under the Programme may also receive a contribution from another Union programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 3. In accordance with point (f) of the first paragraph of Article 195 of the Financial Regulation, grants shall be awarded without a call for proposals where the eligible entities are customs authorities of participating countries, provided that the conditions set out in Article 5 of this Regulation are met. 4. The work of the evaluation committee referred to in Article 150 of the Financial Regulation shall be based on the general principles applicable to grants laid down in Article 188 of the Financial Regulation and in particular, on the principles of equal treatment and transparency laid down in points (a) and (b) of Article 188 of the Financial Regulation, as well as on the principle of non-discrimination. 5. The evaluation committee shall evaluate proposals on the basis of the award criteria, taking into account, where appropriate, the relevance of the proposed action in view of the objectives pursued, the quality of the proposed action, its impact, including its economic, social and environmental impact, and its budget and cost-effectiveness. Article 10 Co-financing rate 1. By way of derogation from Article 190 of the Financial Regulation, the Programme may finance up to 100 % of the total eligible costs of an action. 2. The applicable co-financing rate where actions require the awarding of grants shall be set out in the multiannual work programmes referred to in Article 12. CHAPTER IV SPECIFIC PROVISIONS FOR IT CAPACITY-BUILDING ACTIONS Article 11 Responsibilities 1. The Commission and the Member States shall jointly, and in accordance with the relevant provisions of Union law referred to in the definition in point (2) of Article 2, ensure the development and operation of the European electronic systems, including their design, specification, conformance testing, deployment, maintenance, evolution, modernisation, security, quality assurance and quality control. 2. The Commission shall, in particular, ensure the following: (a) the development and operation of common components; (b) the overall coordination of the development and operation of European electronic systems with a view to achieving their operability, cyber-resilience, interconnectivity, continuous improvement and synchronised implementation, and, as part of that overall coordination, the facilitation of an efficient and swift communication with and between Member States on matters related to those systems; (c) the coordination of European electronic systems at Union level with a view to their promotion and implementation at national level; (d) the coordination of the development and operation of European electronic systems as regards their interactions with third parties, excluding actions designed to meet national requirements; (e) the coordination of European electronic systems with other relevant actions relating to eGovernment at Union level; (f) the timely and transparent communication with the stakeholders that are concerned with the implementation of European electronic systems at Union and Member State level, in particular about delays in the implementation of common and national components. 3. The Member States shall, in particular, ensure the following: (a) the development and operation of national components; (b) the coordination of the development and operation of the national components at national level; (c) the coordination of European electronic systems with other relevant actions relating to eGovernment at national level; (d) the regular provision to the Commission of information on the measures taken to enable the customs authorities or economic operators concerned to make full and effective use of the European electronic systems; (e) the implementation at national level of European electronic systems. 4. The Commission shall publish and regularly update, for information purposes, an indicative list of the European electronic systems financed under the Programme. CHAPTER V PROGRAMMING, MONITORING, EVALUATION AND CONTROL Article 12 Work programme 1. The Programme shall be implemented through multiannual work programmes as referred to in Article 110(2) of the Financial Regulation. 2. In order to ensure the implementation of the Programme, and without prejudice to the Financial Regulation, the Commission shall adopt implementing acts to establish multiannual work programmes. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(2). 3. The multiannual work programmes shall aim to achieve the objectives set out in Article 3 through the actions in accordance with Article 7. They shall set out, where appropriate, the total amount of the financing plan for all actions and shall set out: (a) for each action: (i) the objectives pursued and the expected results, in accordance with the general and specific objectives set out in Article 3; (ii) a description of the actions to be financed; (iii) where appropriate, an indication of the amount allocated to each action; and (iv) the method of implementation and an indicative implementation timetable; (b) for grants, the maximum rate of co-financing referred to in Article 10(2), and where appropriate, the essential award criteria to be applied. Article 13 Monitoring and reporting 1. Indicators to report on the progress of the Programme towards the achievement of the general and specific objectives set out in Article 3 are listed in Annex II. 2. To ensure effective assessment of the Programme\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 16, to amend Annex II with regard to the indicators where considered necessary, as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 3. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements shall be imposed on the recipients of Union funds. Article 14 Evaluation 1. Evaluations shall be carried out in a timely manner so that they can be used in the decision-making process. 2. An interim evaluation of the Programme shall be carried out by the Commission once there is sufficient information available about its implementation, but no later than four years after the start of that implementation. In its interim evaluation, the Commission shall assess the performance of the Programme, including aspects such as effectiveness, efficiency, coherence, relevance, synergies within the Programme and Union added-value. 3. At the end of the implementation of the Programme, but no later than four years after the end of the period specified in Article 1, a final evaluation of the Programme shall be carried out by the Commission. 4. The Commission shall communicate the conclusions of the evaluations, accompanied by its observations and lessons learned, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 15 Protection of the financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. CHAPTER VI EXERCISE OF THE DELEGATION AND COMMITTEE PROCEDURE Article 16 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 13(2) shall be conferred on the Commission until 31 December 2027. The Commission shall draw up a report in respect of the delegation of power not later than nine months before that date. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 13(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 13(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 17 Committee procedure 1. The Commission shall be assisted by a committee referred to as the Customs Programme Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. CHAPTER VII TRANSITIONAL AND FINAL PROVISIONS Article 18 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the Programme, to actions taken pursuant to the Programme and to the results obtained. 3. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. Article 19 Repeal Regulation (EU) No 1294/2013 is repealed with effect from 1 January 2021. Article 20 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulation (EU) No 1294/2013, which shall continue to apply to those actions until their closure. 2. The financial envelope for the Programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted pursuant to Regulation (EU) No 1294/2013. 3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 4(2), to enable the management of actions not completed by 31 December 2027. Article 21 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 March 2021 For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 62, 15.2.2019, p. 45. (2) Position of the European Parliament of 16 April 2019 (not yet published in the Official Journal) and Position of the Council at first reading of 1 March 2021 (OJ C 86, 12.3.2021, p. 1). Position of the European Parliament of 10 March 2021 (not yet published in the Official Journal). (3) Regulation (EU) No 1294/2013 of the European Parliament and of the Council of 11 December 2013 establishing an action programme for customs in the European Union for the period 2014-2020 (Customs 2020) and repealing Decision No 624/2007/EC (OJ L 347, 20.12.2013, p. 209). (4) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (5) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17). (6) Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (OJ L 57, 18.2.2021, p. 1). (7) OJ L 282, 19.10.2016, p. 4. (8) OJ L 433 I, 22.12.2020, p. 28. (9) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (11) OJ L 123, 12.5.2016, p. 1. (12) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (13) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (14) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (15) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (16) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (17) Regulation (EU) 2019/880 of the European Parliament and of the Council of 17 April 2019 on the introduction and the import of cultural goods (OJ L 151, 7.6.2019, p. 1). (18) OJ L 165, 26.6.2009, p. 3. ANNEX I NON-EXHAUSTIVE LIST OF POSSIBLE FORMS OF ACTIONS AS REFERRED TO IN POINTS (A), (B) AND (D) OF THE FIRST SUBPARAGRAPH OF ARTICLE 7(3) Actions referred to in points (a), (b) and (d) of the first subparagraph of Article 7(3) may, inter alia, take the following forms: 1. Meetings and similar ad hoc events \u2014 seminars and workshops, generally attended by participants from all participating countries, at which presentations are made and participants engage in intensive discussions on and activities relating to a particular subject;, \u2014 working visits, organised to enable officials to acquire or increase their expertise or knowledge in customs matters; 2. Project-based structured collaboration \u2014 project groups, generally composed of a limited number of participating countries, that are operational during a limited period of time for the purpose of pursuing a predefined objective with a precisely defined outcome, including coordination or benchmarking, \u2014 task forces, namely structured forms of cooperation, permanent or non-permanent in nature, that pool expertise to perform tasks in specific domains or to carry out operational activities, possibly with the support of online collaboration services, administrative assistance and infrastructure and equipment facilities, \u2014 monitoring activities, carried out by joint teams made up of Commission officials and officials of the eligible authorities to analyse customs practices, to identify any difficulties in implementing rules and, where appropriate, to make suggestions for the adaptation of Union rules and working methods; 3. Human competency and other capacity-building actions \u2014 common training or development of e-learning to support the acquisition of necessary professional skills and knowledge relating to customs, \u2014 technical support aimed at improving administrative procedures, enhancing administrative capacity and improving the functioning and operations of customs authorities through the development and sharing of best practices. ANNEX II INDICATORS AS REFERRED TO IN ARTICLE 13(1) To report on the progress of the Programme towards the achievement of the general and specific objectives set out in Article 3, the following indicators shall be used: A. Capacity building (administrative, human and IT capacity) 1. the Union Law and Policy Application and Implementation Index (the number of actions under the Programme organised in connection with the application and implementation of Union law and policy relating to customs and the number of recommendations issued following those actions); 2. the Learning Index (the number of learning modules used, the number of officials trained and the quality score given by participants); 3. the availability of European electronic systems (in terms of percentage of time); 4. the availability of the Common Communications Network (in terms of percentage of time); 5. the use of key European electronic systems aimed at increasing interconnectivity and moving to a paper-free customs union (number of messages exchanged and consultations carried out); 6. the Union Customs Code (UCC) completion rate (percentage of milestones reached in the implementation of the UCC electronic systems); B. Knowledge sharing and networking 1. the Collaboration Robustness Index (the degree of networking generated, the number of face-to-face meetings and the number of on-line collaboration groups); 2. best Practice and Guideline Index (the number of actions under the Programme organised in connection with the application and implementation of the best practice and guidelines relating to customs and the percentage of participants that made use of guidelines on working practices that have been developed with the support of the Programme).", "summary": "Customs programme \u2014 cooperation in the field of customs Customs programme \u2014 cooperation in the field of customs SUMMARY OF: Regulation (EU) 2021/444 establishing the EU\u2019s programme for cooperation in the field of customs WHAT IS THE AIM OF THE REGULATION? It sets up the Customs programme, the EU\u2019s programme for cooperation in the field of customs, for the period 2021-2027. The main aim of the programme is to further modernise the EU\u2019s Customs Union. The programme supports the EU customs authorities in obtaining the necessary administrative capacity and the related IT environment to carry out their work: to make it easier to handle increasing trade volumes and to deal with new types of trade;to better protect the EU from harmful products and substances;to better protect EU businesses;to make legitimate trade flows easier. KEY POINTS Specific objectives The programme aims to support: the development and uniform implementation of customs legislation and policy; customs cooperation; administrative and IT capacity-building, including human skills and training, and the development and operation of EU electronic systems; innovation in customs policy. Budget The budget allocation for the programme\u2019s implementation is \u20ac950 million for the 2021-2027 period. Participation of non-EU countries and external experts Accession countries, candidate countries and potential candidate countries, countries covered by the European Neighbourhood Policy, and other non-EU countries, may participate in the programme if they meet the conditions laid down in an agreement about non-EU countries\u2019 participation in EU programmes. Representatives of governmental authorities, including those from non-EU countries not participating in the programme, academics and representatives of international and other relevant organisations, representatives of business and representatives of civil society organisations may take part in specific programme activities as external experts, mainly on an ad hoc basis. Eligible actions Meetings and other collaborative actions (e.g. workshops, project groups, study visits). development and operation of IT systems for customs (only the common components and not the national systems). Common training concepts, products and activities (e.g. eLearning modules). Work programme The programme is implemented by means of multiannual work programmes drawn up and adopted by the European Commission by means of implementing acts. Monitoring, reporting and evaluation Annex II lists the indicators used to report on the progress of the programme in achieving its general and specific objectives. The Commission may amend this list by means of delegated acts. The Commission is responsible for carrying out an interim evaluation of the programme no more than 4 years after its launch and a final evaluation within 4 years of its completion. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND The legal basis of this regulation covers customs cooperation as laid down in Article 33 of the Treaty on the Functioning of the European Union (TFEU), the internal market (Article 114 TFEU) and the common commercial policy (Article 207 TFEU). Regulation (EU) No 952/2013 establishes the Union Customs Code, setting out the general rules and procedures that apply to goods brought into or taken out of the EU\u2019s customs territory (see summary). For more information, see: EU Customs Strategy (European Commission) Customs co-operation programmes (European Commission) Customs 2021-2027 (European Commission) EU Customs Union \u2014 Facts and figures (European Commission). MAIN DOCUMENT Regulation (EU) 2021/444 of the European Parliament and of the Council of 11 March 2021 establishing the Customs programme for cooperation in the field of customs and repealing Regulation (EU) No 1294/2013 (OJ L 87, 15.3.2021, pp. 1-16) RELATED DOCUMENTS Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Three \u2014 Union policies and internal actions \u2014 Title II \u2014 Free movement of goods \u2014 Chapter 2 \u2014 Customs cooperation \u2014 Article 33 (ex Article 135 TEC) (OJ C 202, 7.6.2016, p. 61) Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Three \u2014 Union policies and internal actions \u2014 Title VII \u2014 Common rules on competition, taxation and approximation of laws \u2014 Chapter 3 \u2014 Approximation of laws \u2014 Article 114 (ex Article 95 TEC) (OJ C 202, 7.6.2016, pp. 94-95) Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Five \u2014 The Union\u2019s external action \u2014 Title II \u2014 Common commercial policy \u2014 Article 207 (ex Article 133 TEC) (OJ C 202, 7.6.2016, pp. 140-141) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, pp. 1-101) Successive amendments to Regulation (EU) No 952/2013 have been incorporated into the original text. This consolidated version is of documentary value only. last update 04.06.2021"}
{"article": "30.6.2021 EN Official Journal of the European Union L 231/21 REGULATION (EU) 2021/1057 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 June 2021 establishing the European Social Fund Plus (ESF+) and repealing Regulation (EU) No 1296/2013 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 46, point (d), Article 149, Article 153(2), point (a), Article 164, Article 175, third paragraph, and Article 349 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) On 17 November 2017, the European Pillar of Social Rights (the \u2018Pillar\u2019) was jointly proclaimed by the European Parliament, the Council and the Commission as a response to social challenges in Europe. The 20 key principles of the Pillar are structured in three categories: equal opportunities and access to the labour market; fair working conditions; and social protection and inclusion. The 20 principles of the Pillar should guide the actions under the European Social Fund Plus (ESF+). In order to contribute to the implementation of the Pillar, the ESF+ should support investments in people and systems in the policy areas of employment, education and social inclusion, thereby supporting economic, territorial and social cohesion in accordance with Article 174 of the Treaty on the Functioning of the European Union (TFEU). (2) At Union level, the European Semester for economic policy coordination (the \u2018European Semester\u2019) is the framework to identify national reform priorities and monitor their implementation. Member States develop their own national multiannual investment strategies in support of those reform priorities. Those strategies should be presented alongside the yearly national reform programmes in order to outline and coordinate priority investment projects to be supported by Union or national funding. They should also help to use Union funding in a coherent manner and to maximise the added value of the financial support to be received, in particular from the programmes supported by the Union under, where relevant, the European Regional Development Fund (ERDF) and Cohesion Fund the specific objectives and scope of support of which are set out in Regulation (EU) 2021/1058 of the European Parliament and of the Council (4), the ESF+, the European Maritime, Fisheries and Aquaculture Fund (EMFAF) established by a Regulation of the European Parliament and of the Council, the European Agricultural Fund for Rural Development (EAFRD) established by Regulation (EU) No 1305/2013 of the European Parliament and of the Council (5) and the InvestEU Programme established by Regulation (EU) 2021/523 of the European Parliament and of the Council (6) (InvestEU Programme). (3) Revised guidelines for the employment policies of Member States were adopted by means of Council Decision (EU) 2020/1512 (7). The text of those guidelines has been aligned with the principles of the Pillar, with a view to improving Europe\u2019s competitiveness and making it a better place to invest, create jobs and foster social cohesion. In order to ensure the full alignment of the ESF+ with the objectives of those guidelines, particularly as regards employment, education, training and the fight against social exclusion, poverty and discrimination, the ESF+ should support Member States by taking into account the relevant integrated guidelines and relevant country-specific recommendations adopted pursuant to Article 121(2) and Article 148(2) and (4) TFEU and, where appropriate, the national reform programmes underpinned by national strategies. The ESF+ should also contribute to relevant aspects of the implementation of key Union initiatives and activities, in particular the Commission communications of 10 June 2016 entitled \u2018A new Skills Agenda for Europe\u2019, of 30 September 2020 entitled \u2018European Education Area\u2019, and of 7 October 2020 entitled \u2018A Union of Equality: EU Roma strategic framework for equality, inclusion and participation\u2019 as well as the Council Recommendations of 15 February 2016 on the integration of the long-term unemployed into the labour market, of 19 December 2016 on Upskilling Pathways, of 30 October 2020 on A Bridge to Jobs \u2013 Reinforcing the Youth Guarantee and of 12 March 2021 on Roma equality, inclusion and participation. (4) On 20 June 2017, the Council adopted conclusions entitled \u2018A sustainable European future: the EU response to the 2030 Agenda for Sustainable Development\u2019. The Council underlined the importance of achieving sustainable development across the three dimensions (economic, social and environmental) in a balanced and integrated way. It is vital that sustainable development is mainstreamed into all Union internal and external policy areas and that the Union is ambitious in its policies that address global challenges. The Council welcomed the Commission communication of 22 November 2016 entitled \u2018Next steps for a sustainable European future\u2019 as a first step in mainstreaming the United Nations (UN) Sustainable Development Goals (SDGs) and applying sustainable development as an essential guiding principle for all Union policies, including through its financing instruments. The ESF+ should contribute to the implementation of the SDGs by, inter alia, eradicating extreme forms of poverty (SDG 1); promoting quality and inclusive education (SDG 4); promoting gender equality (SDG 5); promoting sustained, inclusive and sustainable economic growth, full and productive employment and decent work for all (SDG 8); and reducing inequality (SDG 10). (5) Recent and ongoing developments have aggravated the structural challenges arising from economic globalisation, social inequalities, the management of migration flows and the increased security threat, clean energy transition, technological change, demographic decline, unemployment, in particular youth unemployment, and an increasingly ageing workforce as well as challenges stemming from growing mismatches between demand and supply of skills and labour in some sectors and regions, experienced especially by small and medium-sized enterprises (SMEs). The green and digital transitions and the transformation of European industrial ecosystems are likely to entail many new opportunities, if accompanied by the right skill sets and employment and social policies and actions. Taking into account the changing realities of the world of work, the Union should be prepared for current and future challenges by investing in relevant skills, education, training and lifelong learning making growth more inclusive and by improving employment and social policies, while taking into account economic and industrial sustainability, labour mobility and aiming to establish a gender balanced labour market. (6) Regulation (EU) 2021/1060 of the European Parliament and of the Council (8) establishes the framework for action by the ERDF, the ESF+, the Cohesion Fund, the Just Transition Fund (JTF) established by Regulation (EU) 2021/1056 of the European Parliament and of the Council (9), the EMFAF, the Asylum, Migration and Integration Fund (AMIF), the Internal Security Fund (ISF) and the Instrument for Financial Support for Border Management and Visa Policy as a part of the Integrated Border Management Fund and lays down, in particular, the policy objectives and the rules concerning programming, monitoring and evaluation, management and control for Union funds implemented under shared management. It is therefore necessary to specify the general objectives of the ESF+ and to lay down specific provisions concerning the type of activities that may be financed by the ESF+. (7) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (10) (the \u2018Financial Regulation\u2019) lays down rules on the implementation of the general budget of the Union (Union budget), including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. Co-financing for grants may be provided from beneficiaries\u2019 own resources, income generated by the project or financial or in-kind contributions from third parties. In order to ensure consistency in the implementation of Union programmes, the Financial Regulation is to apply to the actions to be implemented under direct or indirect management under the ESF+. (8) The forms of Union funding and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. For grants, this should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1), point (a), of the Financial Regulation. To implement measures linked to the socio-economic integration of third-country nationals, and in accordance with Article 94 of the Regulation (EU) 2021/1060, the Commission may reimburse Member States using simplified cost options including lump sums. (9) In order to streamline and simplify the funding landscape and create additional opportunities for synergies through integrated funding approaches, the actions which were supported by the Fund for European Aid to the Most Deprived established by Regulation (EU) No 223/2014 of the European Parliament and of the Council (11), and by the European Union Programme for Employment and Social Innovation established by Regulation (EU) No 1296/2013 of the European Parliament and of the Council (12) should be integrated into the ESF+. The ESF+ should comprise of two strands: the strand under shared management (the \u2018ESF+ strand under shared management\u2019), to be implemented under shared management, and the Employment and Social Innovation strand (the \u2018EaSI strand\u2019), to be implemented under direct and indirect management. This should contribute to reducing the administrative burden linked to the management of different funds, in particular for Member States and beneficiaries, while maintaining simpler rules for simpler operations such as the distribution of food and/or basic material assistance. (10) In view of the wider scope of the ESF+, it is appropriate that the aims to enhance the effectiveness of labour markets, promote equal access to quality employment, improve equal access to and quality of education and training to aid reintegration into education systems, promote social inclusion, facilitate access to healthcare for vulnerable persons and contribute to eradicating poverty, are not only implemented under shared management under ESF+ strand under shared management, but also, for actions required at Union level, under direct and indirect management under the EaSI strand. (11) This Regulation lays down a financial envelope for the entire duration of the ESF+, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (13), for the European Parliament and the Council during the annual budgetary procedure. It should specify the allocation for the ESF+ strand under shared management and the allocation for actions to be implemented under the EaSI strand. (12) With a view to facilitating the implementation of the specific and operational objectives of the EaSI strand, the ESF+ should support activities related to technical and administrative assistance, such as preparatory, monitoring, control, audit and evaluation activities, while communication and dissemination activities should be part of the actions eligible under the EaSI strand. (13) The ESF+ should aim to promote employment by means of active interventions enabling integration and reintegration into the labour market, in particular for young people, especially through the implementation of the reinforced Youth Guarantee, for long-term unemployed people, for disadvantaged groups on the labour market and for inactive people, as well as by means of promoting self\u2013employment and the social economy. The ESF+ should aim to improve the functioning of labour markets by supporting the modernisation of labour market institutions such as the public employment services in order to improve their capacity to provide intensified targeted counselling and guidance during the job search and the transition to employment and to enhance the mobility of workers. The ESF+ should promote a gender-balanced participation in the labour market through measures that aim to ensure, inter alia, equal working conditions, improved work-life balance and access to childcare, including early childhood education and care. The ESF+ should also aim to provide a healthy and well-adapted working environment in order to respond to health risks related to changing forms of work, and the needs of the ageing workforce. (14) The ESF+ should provide support for the improvement of the quality, inclusiveness, effectiveness and labour market relevance of education and training systems, including by the promotion of digital learning, the validation of non-formal and informal learning and the professional development of teaching staff, in order to facilitate the acquisition of key competences in particular as regards basic skills, including health literacy, media literacy, entrepreneurial skills, language skills, digital skills and competencies for sustainable development, which all individuals need for personal fulfilment and development, employment, social inclusion and active citizenship. The ESF+ should help progression within education and training and transition to work, should support lifelong learning and employability with a view to facilitating full participation in society for all, and should contribute to competitiveness, including through graduate tracking, and to societal and economic innovation by supporting sustainable initiatives that are capable of being scaled up in those fields and adapted to different target groups such as persons with disabilities. Such help, support and contribution could be achieved, for example, by means of online learning, work-based training, traineeships, dual education and training systems, and apprenticeships as defined in the Council Recommendation of 15 March 2018 on a European Framework for Quality and Effective Apprenticeships, lifelong guidance, skills anticipation in close cooperation with industry, up-to-date training materials and delivery methods, forecasting and graduate tracking, training of educators, validation of learning outcomes and recognition of qualifications and industry-based certifications. (15) Support from the ESF+ should be used to promote equal access for all, in particular for disadvantaged groups, to quality, non-segregated and inclusive education and training from early childhood education and care, while paying special attention to children coming from a socio-economically disadvantaged background, by means of general and vocational education and training, in particular apprenticeships, to tertiary level, as well as by means of adult education and learning, including through sport and cultural activities. The ESF+ should provide targeted support to learners in need and reduce educational inequalities, including the digital divide, prevent and reduce early school leaving, foster permeability between the education and training sectors, reinforce links with non-formal and informal learning and facilitate learning mobility for all and accessibility for persons with disabilities. Synergies with Erasmus+ established by Regulation (EU) 2021/817 of the European Parliament and of the Council (14), in particular to facilitate the participation of disadvantaged learners in learning mobility, should be supported in this context. (16) The ESF+ should promote flexible opportunities for upgrading of skills and acquiring new and different skills by all, in particular entrepreneurial and digital skills, skills for key enabling technologies and skills for the green economy as well as industrial ecosystems in line with the Commission communication of 10 March 2020 entitled \u2018A New Industrial Strategy for Europe\u2019. In line with the Skills Agenda for Europe and the Council Recommendation on Upskilling Pathways (15), the ESF+ should support flexible pathways, including accessible, short, targeted, modular training leading to credentials, with a view to providing people with the skills that are adjusted to labour market and industrial ecosystems needs, the green and digital transitions, innovation and social and economic change, the facilitation of reskilling and upskilling and employability, career transitions, geographic and sectoral mobility and supporting in particular low-skilled persons, persons with disabilities and poorly qualified adults. The ESF+ should also facilitate the provision of support to individuals with regard to integrated skills, including employed, self-employed and unemployed persons, through instruments such as individual learning accounts. (17) Synergies with Horizon Europe \u2013 the Framework Programme for Research and Innovation \u2013 established by Regulation (EU) 2021/695 of the European Parliament and of the Council (16) (Horizon Europe) should ensure that the ESF+ is able to mainstream and scale up innovative curricula supported by Horizon Europe in order to equip people with the skills and competences needed for the jobs of the future. (18) The ESF+ should support the efforts of Member States to contribute to the eradication of poverty with a view to breaking the cycle of disadvantage across generations and promote social inclusion by ensuring equal opportunities for all, reducing barriers, tackling discrimination and addressing health inequalities. Such support implies mobilising a range of policies targeting the most disadvantaged people regardless of their sex, sexual orientation, age, religion or belief, racial or ethnic origin, in particular marginalised communities such as Roma people, people with disabilities or chronic diseases, homeless people, children and elderly people. The ESF+ should promote the active inclusion of people far from the labour market with a view to ensuring their socio-economic integration. The ESF+ should also be used to enhance timely and equal access to affordable, sustainable and high-quality services that promote the access to housing and person-centred care such as healthcare and long-term care, in particular family and community-based care services. The ESF+ should contribute to the modernisation of social protection systems with a particular focus on children and disadvantaged groups and with a view, in particular, to promoting the accessibility of such systems, including for persons with disabilities. (19) The ESF+ should contribute to the eradication of poverty by supporting national schemes aiming to alleviate food and material deprivation and promote social integration of people at risk of poverty or social exclusion and the most deprived persons. With the overall aim that, at Union level, a minimum of 4 % of the resources of the ESF+ strand under shared management support the most deprived persons, Member States should allocate at least 3 % of their resources of the ESF+ strand under shared management to address the forms of extreme poverty with the greatest social exclusion impact, such as homelessness, child poverty and food deprivation. The provision of food and/or basic material assistance to the most deprived persons should not replace existing social benefits provided to them under national social systems or pursuant to national law. Due to the nature of the operations and the type of end recipients, it is necessary that simpler rules apply to support which addresses material deprivation of the most deprived persons. (20) In light of the persistent need to enhance efforts to address the management of migration flows in the Union as a whole and in order to ensure a coherent, strong and consistent support to solidarity and responsibility-sharing efforts, the ESF+ should provide support to promote the socio-economic integration of third-country nationals, including migrants, which may include initiatives at local level, complementary to the actions financed under the AMIF, the ERDF and other Union funds which can have a positive effect on the inclusion of third-country nationals. (21) Due to the importance of access to healthcare, the ESF+ should ensure synergies and complementarities with the EU4Health Programme established by Regulation (EU) 2021/522 of the European Parliament and of the Council (17) and the scope of the ESF+ should include access to healthcare for people in vulnerable situations. (22) The ESF+ should support policy and system reforms in the fields of employment, social inclusion, access to healthcare for vulnerable persons, long-term care, education and training, contributing to poverty eradication. In order to strengthen alignment with the European Semester, Member States should allocate an appropriate amount of their resources of the ESF+ strand under shared management to implement relevant country-specific recommendations relating to structural challenges which it is appropriate to address through multiannual investments falling within the scope of the ESF+, taking into account the Pillar, the Social Scoreboard of indicators, as revised following the adoption of the new targets set out in the Social Pillar Action Plan, and regional specificities. The Commission and Member States should ensure coherence, coordination and complementarity between the ESF+ strand under shared management and other Union funds, programmes and instruments such as the JTF, the ERDF, the EU4Health Programme, the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (18), the European Globalisation Adjustment Fund for Displaced Workers established by Regulation (EU) 2021/691 of the European Parliament and of the Council (19), the EMFAF, Erasmus+, the AMIF, Horizon Europe, the EAFRD, the Digital Europe Programme established by Regulation (EU) 2021/694 of the European Parliament and of the Council (20), InvestEU Programme, the Creative Europe Programme established by Regulation (EU) 2021/818 of the European Parliament and of the Council (21), the European Solidarity Corps established by Regulation (EU) 2021/888 of the European Parliament and of the Council (22), and the Technical Support Instrument established by Regulation (EU) 2021/240 of the European Parliament and of the Council (23). In particular, the Commission and Member States should ensure, in all stages of the process, effective coordination in order to safeguard the consistency, coherence, complementarity and synergy among sources of funding, including technical assistance thereof. (23) By supporting the specific objectives set out in this Regulation, inter alia, by contributing to the policy objective \u2018a more social and inclusive Europe implementing the European Pillar of Social Rights\u2019 as referred to in Regulation (EU) 2021/1060, the ESF+ will continue to contribute to territorial and local development strategies in order to implement the Pillar. It will support the tools set out in Article 28 of that Regulation and thereby also contribute to the delivery of the policy objective \u2018a Europe closer to citizens by fostering the sustainable and integrated development of all types of territories and local initiatives\u2019 as referred to in Regulation (EU) 2021/1060, including through poverty reduction and social inclusion measures, taking into account the specificities of urban, rural and coastal regions in view of tackling the socio-economic inequalities in cities and regions. (24) In order to ensure that the social dimension of Europe, as set out in the Pillar, is duly put forward and that a minimum amount of resources is targeting those that are most in need, Member States should allocate at least 25 % of their resources of the ESF+ strand under shared management to foster social inclusion. (25) In order to address the persistently high level of child poverty in the Union, and in line with principle 11 of the Pillar, which states that children have the right to protection from poverty and that children from disadvantaged backgrounds have the right to specific measures to enhance equal opportunities, Member States should programme an appropriate amount of their resources of the ESF+ strand under shared management for the implementation of the Child Guarantee for activities addressing child poverty in line with the specific objectives of the ESF+ that allow for programming resources towards actions directly supporting children\u2019s equal access to childcare, education, healthcare, decent housing and adequate nutrition. Member States that had an average rate above the Union average of children of less than 18 years old at risk of poverty or social exclusion for the period between 2017 and 2019, on the basis of Eurostat data, should allocate at least 5 % of their resources of the ESF+ strand under shared management to those activities. Operations contributing to this thematic concentration requirement should count towards the 25 % of thematic concentration requirement for social inclusion when programmed under the relevant specific objectives. (26) In order to facilitate an inclusive economic recovery after a major crisis and to support youth employment in a changing world of work and in light of persistently high levels of youth unemployment and inactivity in a number of Member States and regions, it is necessary that Member States invest an appropriate amount of their ESF+ resources in measures to support youth employment and skills, including through the implementation of schemes under the Youth Guarantee. Building on the actions supported by the Youth Employment Initiative in the 2014 to 2020 programming period under Regulation (EU) No 1304/2013 of the European Parliament and of the Council (24), which target individuals and on the lessons learnt, Member States should further promote quality employment and education reintegration pathways and invest in early prevention and effective outreach by prioritising, where relevant, long-term unemployed, inactive and disadvantaged young people including through youth work. Member States should also invest in measures aiming to facilitate the transition from school to work as well as adequate capacities of employment services to provide tailor-made and holistic support and better-targeted offers to young people. By fully integrating the Youth Employment Initiative into the ESF+, the delivery of targeted actions for youth employment will be more effective and efficient and the scope will be extended to structural measures and reforms, thus ensuring a better match between support from Union funding and the implementation of the reinforced Youth Guarantee. Upgrading of skills and acquiring new and different skills should help young people seize the opportunities of growing sectors and prepare them for the changing nature of work, while harnessing the opportunities arising from the digital and green transitions and the transformation of the Union industrial ecosystems. Therefore, Member States that had an average rate above the Union average of young people of 15 to 29 years of age who are not in employment, education or training for the period between 2017 and 2019, on the basis of Eurostat data, should allocate at least 12,5 % of their resources of the ESF+ strand under shared management to those actions. (27) In accordance with Article 349 TFEU and Article 2 of Protocol No 6 on special provisions for Objective 6 in the framework of the Structural Funds in Finland, Norway and Sweden annexed to the 1994 Act of Accession (25), the outermost regions and the northern sparsely populated regions are entitled to specific measures under common policies and Union programmes. Due to the permanent constraints, such as depopulation, those regions require specific support. (28) Efficient and effective implementation of actions supported by the ESF+ depends on good governance and partnership between all actors at the relevant territorial levels and the socio-economic actors, in particular the social partners and civil society organisations. It is therefore essential that Member States allocate an appropriate amount of their resources of the ESF+ strand under shared management to ensure meaningful participation of the social partners and civil society organisations in the implementation of the ESF+ strand under shared management. That participation should include relevant bodies representing civil society, such as environmental partners, non-governmental organisations, and bodies responsible for promoting social inclusion, fundamental rights, the rights of persons with disabilities, gender equality and non-discrimination. Member States with a country-specific recommendation on capacity building of the social partners or civil society organisations should allocate at least 0,25 % of their resources of the ESF+ strand under shared management for that purpose due to the specific needs they have in that area. (29) With a view to rendering policies more responsive to social change as well as to encouraging and supporting innovative solutions, support for social innovation is crucial. In particular, testing and evaluating innovative solutions before scaling them up is instrumental in improving the efficiency of the policies and thus specific support from the ESF+ is justified. Social economy enterprises could play a key role in delivering on social innovation and contributing to economic and social resilience. The definition of a social economy enterprise should be in line with the definitions provided in national law and the Council conclusions of 7 December 2015 on the promotion of the social economy as a key driver of economic and social development in Europe. Moreover, with a view to enhancing mutual learning and exchange of knowledge and practices, Member States should be encouraged to continue their transnational cooperation actions under shared management in the areas of employment, education and training, and social inclusion in line with the specific objectives of the ESF+. (30) Member States and the Commission should ensure that the ESF+ contributes to the promotion of equality between women and men in accordance with Article 8 TFEU to foster equality of treatment and opportunities between women and men in all areas, including participation in the labour market, terms and conditions of employment and career progression. They should also ensure that the ESF+ promotes equal opportunities for all, without discrimination in accordance with Article 10 TFEU, promotes the inclusion in society of persons with disabilities on equal basis with others and contributes to the implementation of the UN Convention on the Rights of Persons with Disabilities adopted on 13 December 2006 in New York. The ESF+ should contribute to the promotion of accessibility for persons with disabilities with a view to improving integration into employment, education and training, thereby enhancing their inclusion in all spheres of life. The promotion of such accessibility should be taken into account in all dimensions and in all stages of the preparation, monitoring, implementation and evaluation of programmes, in a timely and consistent manner while ensuring that specific actions are taken to promote gender equality and equal opportunities. The ESF+ should also promote the transition from residential or institutional care to family- and community-based care, in particular for those who face multiple discrimination. The ESF+ should not support any action that contributes to segregation or to social exclusion. Regulation (EU) 2021/1060 provides that rules on eligibility of expenditure are to be established at national level, with certain exceptions for which it is necessary to lay down specific provisions with regard to the ESF+ strand under shared management. (31) All operations should be selected and implemented respecting the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019). The Commission should do its utmost to ensure that complaints are assessed in a timely manner, including complaints related to infringements of the Charter, and should inform the complainant of the result of the assessment in line with the Commission communication of 19 January 2017 entitled \u2018EU law: Better results through better application\u2019. (32) In order to reduce the administrative burden for the collection of data, reporting requirements should be kept as simple as possible. Where data are available in registers or equivalent sources, Member States should be able to allow managing authorities to collect data from registers. (33) With regard to the processing of personal data within the framework of this Regulation, national data controllers should carry out their tasks for the purposes of this Regulation in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (26). The dignity of and respect for the privacy of end recipients of operations under the specific objective \u2018addressing material deprivation through food and/or basic material assistance to the most deprived persons, including children, and providing accompanying measures supporting their social inclusion\u2019 should be guaranteed. In order to avoid any stigmatisation, the persons receiving food and/or basic material assistance should not be required to identify themselves when receiving the support and when taking part in surveys on the most deprived persons who have benefitted from the ESF+. (34) Social experimentation is a small-scale project testing which allows gathering of evidence on the feasibility of social innovations. It should be possible and encouraged for ideas to be tested at local level and for those ideas that are feasible to be pursued on a wider scale, where appropriate, or transferred to other contexts in different regions or Member States with financial support from the ESF+ or in combination with other sources. (35) The ESF+ lays down provisions intended to achieve freedom of movement for workers on a non-discriminatory basis by ensuring close cooperation of the public employment services of Member States, the Commission and the social partners. The European network of employment services should promote better functioning of the labour markets by facilitating the cross-border mobility of workers, in particular through cross-border partnerships, and a greater transparency of information on the labour markets. The scope of the ESF+ should include developing and supporting targeted mobility schemes with a view to filling vacancies where labour market shortcomings have been identified. (36) The lack of access to finance of microenterprises, social enterprises and social economy is one of the main obstacles to business creation, especially among people furthest from the labour market. Under the EaSI strand, this Regulation should lay down provisions in order to create a market ecosystem to increase the supply of and access to finance for social enterprises as well as to meet demand from those who need it most, and, in particular, the unemployed, women and vulnerable people who wish to start up or develop a microenterprise. That objective will also be addressed through financial instruments and budgetary guarantees under the social investment and skills policy window of the InvestEU Fund. Social economy enterprises, where they are defined under national law, should be regarded as social enterprises within the context of the EaSI strand, regardless of their legal status, insofar as those enterprises fall within the definition of a social enterprise provided for in this Regulation. (37) Social investment market players, including philanthropic actors, could play a key role in achieving several ESF+ objectives, as they offer financing as well as innovative and complementary approaches to combatting social exclusion and poverty, reducing unemployment and contributing to the SDGs. Therefore, philanthropic actors such as foundations and donors should be involved in ESF+ actions, as appropriate and provided that they do not have a political or social agenda that is in conflict with Union ideals, in particular in those actions that aim to develop the social investment market ecosystem. (38) Guidance under the EaSI strand is needed with regard to the development of social infrastructures and related services, in particular for social housing, childcare and education, healthcare and long-term care, including facilities to assist transitions from institutional- to family- and community-based care services and taking into account accessibility requirements for persons with disabilities. (39) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement, adopted under the UN Framework Convention on Climate Change (27), and the SDGs, this Regulation will contribute to mainstream climate actions and to the achievement of an overall target of 30 % of Union budget expenditure supporting climate objectives. Relevant actions will be identified during the preparation and implementation, and reassessed in the context of the mid-term evaluation. (40) Pursuant to Council Decision 2013/755/EU (28), persons and entities established in overseas countries and territories are to be eligible for funding subject to the rules and objectives of the EaSI strand and arrangements applicable to the Member State to which the relevant overseas countries and territories are linked. (41) Third countries which are members of the European Economic Area may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (29), which provides for the implementation of the programmes on the basis of a decision under that agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, the European Anti-Fraud Office (OLAF) and the Court of Auditors to comprehensively exercise their respective competences. (42) It is appropriate to lay down indicators for the purposes of reporting under the EaSI strand. Those indicators should be output-based, objective, easy to retrieve, and proportionate to the share of the EaSI strand within the entire ESF+. They should cover the operational objectives and funding activities under the EaSI strand, without requiring the setting of corresponding targets. (43) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (30) and Council Regulations (EC, Euratom) No 2988/95 (31), (Euratom, EC) No 2185/96 (32) and (EU) 2017/1939 (33), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, OLAF has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union, as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (34). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation, pursuant to Regulation (EU) 2017/1939, the EPPO and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (44) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, prizes, procurement, indirect management, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (45) Since the objectives of this Regulation, namely enhancing the effectiveness of labour markets, promoting equal access to quality employment, improving equal access to, and the quality of, education and training, promoting social inclusion and contributing to the eradication of poverty, as well as the objectives pursued under the EaSI strand cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (46) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending and supplementing the annexes on the indictors. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (35). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (47) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. The implementing powers relating to the model for the structured survey of end recipients should be exercised in accordance with the advisory procedure referred to in Article 4 of Regulation (EU) No 182/2011 of European Parliament and of the Council (36) given the nature of this model. (48) In order to allow for a rapid response to exceptional or unusual circumstances, as referred to in the Stability and Growth Pact, that may arise during the programming period, implementing powers should be conferred on the Commission to adopt temporary measures to facilitate the use of support from the ESF+ in response to such circumstances, with a maximum time limit of 18 months. The Commission should adopt the measures that are most appropriate in light of the exceptional or unusual circumstances that a Member State is facing while preserving the objectives of the ESF+, but this should not include amendments to the thematic concentration requirements. Furthermore, the implementing powers in relation to the temporary measures for the use of support from the ESF+ in response to exceptional or unusual circumstances should be conferred on the Commission without committee procedures, given that the scope of application of those measures is determined by the Stability and Growth Pact and is limited to the measures set out in this Regulation. The Commission should also monitor the implementation and assess the appropriateness of the temporary measures. Where the Commission deems it to be necessary to amend this Regulation due to the exceptional or unusual circumstances, the scope of the amendment should not include the thematic concentration requirements related to youth employment nor support for the most deprived persons due to the fact that young people and the most deprived persons are often most adversely affected by such crisis situations. Therefore it is necessary to ensure that those target groups continue to receive an adequate amount of support. (49) In the administration of the ESF+, the Commission should be assisted by a Committee as referred to in Article 163 TFEU (the \u2018ESF+ Committee\u2019). In order to enable the ESF+ Committee to have all the necessary information at its disposal and obtain a wide range of views of relevant stakeholders, the ESF+ Committee should be able to invite representatives without a voting right provided that the agenda of the meeting requires their participation, including representatives of the European Investment Bank and the European Investment Fund and relevant civil society organisations. (50) In order to ensure that the specificities of each ESF+ strand continue to be addressed, the ESF+ Committee should establish working groups for each ESF+ strand. Composition and tasks of those working groups are to be established by the ESF+ Committee. The working groups should have the possibility to invite civil society representatives as well as other stakeholders to their meetings. The tasks of the working groups may include ensuring coordination and cooperation between Member State authorities and the Commission on the implementation of the ESF+, including consultation on the work programme of the EaSI strand, monitoring the implementation of each ESF+ strand, exchanging experience and good practice within and across the ESF+ strands and fostering potential synergies with other Union programmes. (51) In order to ensure a greater transparency regarding the implementation of this Regulation, the Commission should establish the necessary links with relevant policy committees active in the social and employment field, such as the Employment Committee, the Social Protection Committee or the Advisory Committee on Safety and Health at Work. (52) In accordance with Article 193(2) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to the signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to Union\u2019s interests, it should be possible to provide in the financing decision, during a limited period of time at the beginning of the multiannual financial framework 2021 to 2027, and only in duly justified cases, for eligibility of activities and costs from the beginning of the 2021 financial year, even if they were implemented and incurred before the grant application was submitted. (53) Regulation (EU) No 1296/2013 should therefore be repealed. (54) In order to ensure continuity in providing support in the relevant policy area and to allow implementation as of the beginning of the multiannual financial framework 2021 to 2027, this Regulation should enter info force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union and should apply, with retroactive effect with regard to the EaSI strand, from 1 January 2021, HAVE ADOPTED THIS REGULATION: TABLE OF CONTENTS Part I General provisions Article 1 Subject matter Article 2 Definitions Article 3 General objectives of the ESF+ and methods of implementation Article 4 Specific objectives of the ESF+ Article 5 Budget Article 6 Gender equality, equal opportunities and non-discrimination Part II Implementation under shared management Chapter I Common provisions on programming Article 7 Consistency and thematic concentration Article 8 Respect for the Charter Article 9 Partnership Article 10 Support for the most deprived persons Article 11 Support for youth employment Article 12 Support for relevant country-specific recommendations Chapter II General support from the ESF+ strand under shared management Article 13 Scope Article 14 Social innovative actions Article 15 Transnational cooperation Article 16 Eligibility Article 17 Indicators and reporting Chapter III ESF+ support for addressing material deprivation Article 18 Scope Article 19 Principles Article 20 Content of the priority Article 21 Eligibility of operations Article 22 Eligibility of expenditure Article 23 Indicators and reporting Article 24 Audit Part III Implementation under direct and indirect management Chapter I Operational objectives Article 25 Operational objectives Chapter II Eligibility Article 26 Eligible actions Article 27 Eligible entities Article 28 Horizontal principles Article 29 Participation of third countries Chapter III General provisions Article 30 Forms of Union funding and methods of implementation Article 31 Work programme Article 32 Monitoring and reporting Article 33 Protection of the financial interests of the Union Article 34 Evaluation Article 35 Audits Article 36 Information, communication and publicity Part IV Final Provisions Article 37 Exercise of the delegation Article 38 Committee procedure for the ESF+ strand under shared management Article 39 Committee set up under Article 163 TFEU Article 40 Transitional provisions for the ESF+ strand under shared management Article 41 Transitional provisions for the EaSI strand Article 42 Entry into force ANNEX I Common indicators for general support from the ESF+ strand under shared management ANNEX II Common indicators for the ESF+ actions targeting social inclusion of the most deprived persons within the specific objective set out in Article 4(1), point (l), in line with Article 7(5), first subparagraph ANNEX III Common indicators for ESF+ support for addressing material deprivation ANNEX IV Indicators for the EaSI strand PART I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the European Social Fund Plus (ESF+), which consists of two strands: the strand under shared management (the \u2018ESF+ strand under shared management\u2019) and the Employment and Social Innovation strand (the \u2018EaSI strand\u2019). This Regulation lays down the objectives of the ESF+, its budget for the period 2021 to 2027, the methods of implementation, the forms of Union funding and the rules for providing such funding. Article 2 Definitions 1. For the purposes of this Regulation, the following definitions apply: (1) \u2018lifelong learning\u2019 means learning in all its forms, namely, formal, non-formal and informal learning, that takes place at all stages in life and results in an improvement or an update in knowledge, skills, competences and attitudes or in participation in society in a personal, civic, cultural, social or employment-related perspective, including the provision of counselling and guidance services, including early childhood education and care, general education, vocational education and training, higher education, adult education, youth work and other learning settings outside formal education and training and it typically promotes cross-sectoral cooperation and flexible learning pathways; (2) \u2018third-country national\u2019 means a person who is not a citizen of the Union, including stateless persons and persons with an undetermined nationality; (3) \u2018basic material assistance\u2019 means goods which fulfil the basic needs of a person for a life with dignity, such as clothing, hygiene goods, including feminine hygiene products, and school material; (4) \u2018disadvantaged group\u2019 means a group of people in vulnerable situations, including people experiencing or at risk of poverty, social exclusion or discrimination in its multiple dimensions; (5) \u2018key competences\u2019 means the knowledge, skills and competences all individuals need, at any stage of their lives, for their personal fulfilment and development, employment, social inclusion and active citizenship, namely, literacy; multilingualism; mathematics, science, technology, arts and engineering; digital skills; media skills; personal, social and learning to learn skills; active citizenship skills; entrepreneurship; cultural and intercultural awareness and expression; and critical thinking; (6) \u2018most deprived persons\u2019 means natural persons, whether individuals, families, households or groups of persons, including children in vulnerable situations and homeless people, whose need for assistance has been established according to the objective criteria which are set by the national competent authorities in consultation with relevant stakeholders while avoiding conflicts of interest, and which may include elements that allow for the targeting of the most deprived persons in certain geographical areas; (7) \u2018end recipients\u2019 means the most deprived persons receiving the support as laid down in Article 4(1), point (m); (8) \u2018social innovation\u2019 means an activity, that is social both as to its ends and its means and in particular an activity which relates to the development and implementation of new ideas concerning products, services, practices and models, that simultaneously meets social needs and creates new social relationships or collaborations between public, civil society or private organisations, thereby benefiting society and boosting its capacity to act; (9) \u2018accompanying measure\u2019 means an activity provided in addition to the distribution of food and/or basic material assistance with the aim of addressing social exclusion and contributing to the eradication of poverty, such as referrals to or providing social and health services, including psychological support, or providing relevant information on public services or advice on managing a household budget; (10) \u2018social experimentation\u2019 means a policy intervention that aims to provide an innovative response to social needs, implemented on a small scale and in conditions that enable its impact to be measured, prior to being implemented in other contexts including geographical and sectorial ones, or implemented on a larger scale, if the results prove to be positive; (11) \u2018cross-border partnership\u2019 means a structure of cooperation between public employment services, the social partners or civil society located in at least two Member States; (12) \u2018microenterprise\u2019 means an enterprise with fewer than 10 employees and an annual turnover or balance sheet below EUR 2 000 000; (13) \u2018social enterprise\u2019 means an undertaking, regardless of its legal form, including social economy enterprises, or a natural person which: (a) in accordance with its articles of association, statutes or with any other legal document that may result in liability under the rules of the Member State where a social enterprise is located, has the achievement of measurable, positive social impacts, which may include environmental impacts, as its primary social objective rather than the generation of profit for other purposes, and which provides services or goods that generate a social return or employs methods of production of goods or services that embody social objectives; (b) uses its profits first and foremost to achieve its primary social objective, and has predefined procedures and rules that ensure that the distribution of profits does not undermine the primary social objective; (c) is managed in an entrepreneurial, participatory, accountable and transparent manner, in particular by involving workers, customers and stakeholders on whom its business activities have an impact; (14) \u2018reference value\u2019 means a value which is used to set targets for common and programme specific result indicators and based on existing or previous, similar interventions; (15) \u2018cost of purchasing food and/or basic material assistance\u2019 means the actual costs which are linked to the purchase of food and/or basic material assistance by the beneficiary and are not limited to the price of the food and/or basic material assistance; (16) \u2018microfinance\u2019 includes guarantees, microcredit, equity and quasi-equity, coupled with accompanying business development services such as those provided in the form of individual counselling, training and mentoring, extended to persons and microenterprises that experience difficulties accessing credit for the purpose of professional and revenue-generating activities; (17) \u2018blending operation\u2019 means an action supported by the Union budget, including within a blending facility or platform as defined in Article 2, point (6), of the Financial Regulation, combining non-repayable forms of support or financial instruments from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; (18) \u2018legal entity\u2019 means a natural person, or a legal person created and recognised as such under Union, national, or international law, which has legal personality and the capacity to act in its own name, exercise rights and be subject to obligations, or an entity which does not have legal personality as referred to in Article 197(2), point (c), of the Financial Regulation; (19) \u2018common immediate result indicator\u2019 means a common result indicator which captures effects within four weeks from the day on which the participant has left the operation; (20) \u2018common longer-term result indicator\u2019 means a common result indicator which captures effects six months after the participant has left the operation. 2. The definitions set out in Article 2 of Regulation (EU) 2021/1060 also apply to the ESF+ strand under shared management. Article 3 General objectives of the ESF+ and methods of implementation 1. The ESF+ aims to support Member States and regions to achieve high employment levels, fair social protection and a skilled and resilient workforce ready for the future world of work, as well as inclusive and cohesive societies aiming to eradicating poverty and delivering on the principles set out in the European Pillar of Social Rights. 2. The ESF+ shall support, complement and add value to the policies of Member States to ensure equal opportunities, equal access to the labour market, fair and quality working conditions, social protection and inclusion, in particular focussing on quality and inclusive education and training, lifelong learning, investment in children and young people and access to basic services. 3. The ESF+ shall be implemented: (a) under shared management, for the part of the assistance which corresponds to the specific objectives set out in Article 4(1) (ESF+ strand under shared management); and (b) under direct and indirect management, for the part of the assistance which corresponds to the objectives set out in Article 4(1) and Article 25 (EaSI strand). Article 4 Specific objectives of the ESF+ 1. The ESF+ shall support the following specific objectives in the policy areas of employment and labour mobility, education, social inclusion, including contributing to poverty eradication, and thereby also contributing to the policy objective \u2018a more social and inclusive Europe implementing the European Pillar of Social Rights\u2019 referred to in Article 5, point (d), of Regulation (EU) 2021/1060: (a) improving access to employment and activation measures for all jobseekers, in particular young people, especially through the implementation of the Youth Guarantee, for long-term unemployed and disadvantaged groups on the labour market, and for inactive people, as well as through the promotion of self-employment and the social economy; (b) modernising labour market institutions and services to assess and anticipate skills needs and ensure timely and tailor-made assistance and support for labour market matching, transitions and mobility; (c) promoting a gender-balanced labour market participation, equal working conditions, and a better work-life balance including through access to affordable childcare, and care for dependent persons; (d) promoting the adaptation of workers, enterprises and entrepreneurs to change, active and healthy ageing and a healthy and well-adapted working environment that addresses health risks; (e) improving the quality, inclusiveness, effectiveness and labour market relevance of education and training systems including through validation of non-formal and informal learning, to support acquisition of key competences including entrepreneurial and digital skills, and by promoting the introduction of dual-training systems and apprenticeships; (f) promoting equal access to and completion of quality and inclusive education and training, in particular for disadvantaged groups, from early childhood education and care through general and vocational education and training, to tertiary level, as well as adult education and learning, including facilitating learning mobility for all and accessibility for persons with disabilities; (g) promoting lifelong learning, in particular flexible upskilling and reskilling opportunities for all taking into account entrepreneurial and digital skills, better anticipating change and new skills requirements based on labour market needs, facilitating career transitions and promoting professional mobility; (h) fostering active inclusion with a view to promoting equal opportunities, non-discrimination and active participation, and improving employability, in particular for disadvantaged groups; (i) promoting socio-economic integration of third-country nationals, including migrants; (j) promoting the socio-economic integration of marginalised communities, such as Roma people; (k) enhancing equal and timely access to quality, sustainable and affordable services, including services that promote the access to housing and person-centred care including healthcare; modernising social protection systems, including promoting access to social protection, with a particular focus on children and disadvantaged groups; improving accessibility including for persons with disabilities, effectiveness and resilience of healthcare systems and long-term care services; (l) promoting social integration of people at risk of poverty or social exclusion, including the most deprived persons and children; (m) addressing material deprivation through food and/or basic material assistance to the most deprived persons, including children, and providing accompanying measures supporting their social inclusion. 2. Through the actions implemented under the ESF+ strand under shared management to achieve the specific objectives referred to in paragraph 1 of this Article, the ESF+ shall aim to contribute to the other policy objectives listed in Article 5 of Regulation (EU) 2021/1060, in particular the objectives related to: (a) a smarter Europe through the development of skills for smart specialisation, skills for key enabling technologies, industrial transition, sectorial cooperation on skills and entrepreneurship, the training of researchers, networking activities and partnerships between higher education institutions, vocational and educational training institutions, research and technological centres and enterprises and clusters, and support for micro, small and medium-sized enterprises and the social economy; (b) a greener, low carbon Europe through the improvement of education and training systems necessary for the adaptation of skills and qualifications, the upskilling of all, including the labour force, the creation of new jobs in sectors related to the environment, climate, energy, the circular economy and the bioeconomy. 3. Where strictly necessary as a temporary measure to respond to exceptional or unusual circumstances as referred to in Article 20 of Regulation (EU) 2021/1060, and limited to a period of 18 months, the ESF+ may support: (a) the financing of short-time work schemes without the requirement that they be combined with active measures; (b) access to healthcare including for people who are not in imminent socio-economic vulnerability. 4. Where, upon a request submitted by the Member States concerned, the Commission finds that the conditions laid down in paragraph 3 are fulfilled, it shall adopt an implementing decision specifying the period during which the temporary additional support from the ESF+ is authorised. 5. The Commission shall monitor the implementation of paragraph 3 of this Article and assess whether the temporary additional support from ESF+ is sufficient to facilitate the use of support from the ESF+ in response to the exceptional or unusual circumstances. On the basis of its assessment, the Commission shall, where appropriate, make proposals for amendments to this Regulation, including on the thematic concentration requirements set out in Article 7, except the thematic concentration requirement as specified in Article 7(5) and (6). Article 5 Budget 1. The financial envelope for the implementation of the ESF+ for the period 2021 to 2027 shall be EUR 87 995 063 417, in 2018 prices. 2. The part of the financial envelope for the implementation of the ESF+ strand under shared management to contribute to the investment for jobs and growth goal in Member States and regions as referred to Article 5(2), point (a), of Regulation (EU) 2021/1060 shall be EUR 87 319 331 844, in 2018 prices, of which EUR 175 000 000 shall be allocated for transnational cooperation to accelerate the transfer, and facilitate the scaling up, of innovative solutions as referred to in Article 25, point (i), of this Regulation and EUR 472 980 447, in 2018 prices, as additional funding to the outermost regions identified in Article 349 TFEU and the NUTS level 2 regions fulfilling the criteria laid down in Article 2 of Protocol No 6 on special provisions for Objective 6 in the framework of the Structural Funds in Finland, Norway and Sweden annexed to the 1994 Act of Accession (Protocol No 6). 3. The part of the financial envelope for the implementation of the EaSI strand for the period 2021 to 2027 shall be EUR 675 731 573, in 2018 prices. 4. The amount referred to in paragraph 3 may also be used for technical and administrative assistance for the implementation of the EaSI strand, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems. Article 6 Gender equality, equal opportunities and non-discrimination Member States and the Commission shall support specific targeted actions to promote the horizontal principles referred to in Article 9(2) and (3) of Regulation (EU) 2021/1060 and Article 28 of this Regulation that fall within any of the objectives of the ESF+. Those actions may include actions for ensuring accessibility for persons with disabilities, including in terms of information and communication technologies, and promoting the transition from residential or institutional care to family and community-based care. Through the ESF+, Member States and the Commission shall aim to increase the participation of women in employment as well as conciliation between working and personal life, combat the feminisation of poverty and gender discrimination in the labour market and in education and training. PART II IMPLEMENTATION UNDER SHARED MANAGEMENT CHAPTER I Common provisions on programming Article 7 Consistency and thematic concentration 1. Member States shall programme their resources of the ESF+ strand under shared management by prioritising interventions that address the challenges identified in the European Semester, including in their national reform programmes as well as in the relevant country-specific recommendations adopted in accordance with Article 121(2) and Article 148(4) TFEU, and take into account the principles and rights set out in the European Pillar of Social Rights and the national and regional strategies relevant for ESF+ objectives, thereby contributing to the goals set out in Article 174 TFEU. Member States and, where appropriate, the Commission shall foster synergies and ensure coordination, complementarity and coherence between the ESF+ and other Union funds, programmes and instruments, both in the planning phase and during implementation. Member States and, where appropriate, the Commission shall optimise mechanisms for coordination to avoid duplication of efforts and ensure close cooperation between entities responsible for implementation to deliver coherent and streamlined support actions. 2. Member States shall allocate an appropriate amount of their resources of the ESF+ strand under shared management to address challenges identified in relevant country-specific recommendations adopted in accordance with Article 121(2) and Article 148(4) TFEU and in the European Semester falling within the scope of the specific objectives of the ESF+ set out in Article 4(1) of this Regulation. 3. Member States shall allocate an appropriate amount of their resources of the ESF+ strand under shared management for the implementation of the Child Guarantee through targeted actions and structural reforms to tackle child poverty under the specific objectives set out in Article 4(1), points (f) and (h) to (l). Member States that had an average rate above the Union average of children of less than 18 years old at risk of poverty or social exclusion for the period between 2017 and 2019, on the basis of Eurostat data, shall allocate at least 5 % of their resources of the ESF+ strand under shared management to support targeted actions and structural reforms to tackle child poverty as set out in the first subparagraph. 4. Member States shall allocate at least 25 % of their resources of the ESF+ strand under shared management to the specific objectives for the social inclusion policy area set out in Article 4(1), points (h) to (l), including the promotion of the socio-economic integration of third-country nationals. 5. Member States shall allocate at least 3 % of their resources of the ESF+ strand under shared management to support the most deprived persons under the specific objective set out in Article 4(1), point (m), or, in duly justified cases, either the specific objective set out in Article 4(1), point (l), or both of those specific objectives. The resources shall not be taken into account for verifying compliance with the minimum allocations set out in paragraphs 3 and 4. 6. Member States shall allocate an appropriate amount of their resources of the ESF+ strand under shared management to targeted actions and structural reforms to support youth employment, vocational education and training, in particular apprenticeships, and the transition from school to work, pathways to reintegrate into education or training and second chance education, in particular in the context of implementing schemes under the Youth Guarantee. Member States that had an average rate above the Union average of young people of 15 to 29 years of age who are not in employment, education or training for the period between 2017 and 2019, on the basis of Eurostat data, shall allocate at least 12,5 % of their resources of the ESF+ strand under shared management for the years 2021 to 2027 to support the targeted actions and structural reforms as set out in the first subparagraph. Outermost regions fulfilling the conditions set out in the second subparagraph shall allocate at least 12,5 % of their resources of the ESF+ strand under shared management in their programmes to the targeted actions and structural reforms as set out in the first subparagraph. This allocation shall be taken into account for verifying compliance with the minimum percentage at national level set out in the second subparagraph when applicable. When implementing targeted actions and structural reforms referred to in this paragraph, Member States shall give priority to inactive and long-term unemployed young people and put in place targeted outreach measures. 7. Paragraphs 2 to 6 of this Article shall not apply to the specific additional allocation received by the outermost regions and the NUTS level 2 regions fulfilling the criteria laid down in Article 2 of Protocol No 6. 8. Paragraphs 1 to 6 shall not apply to technical assistance. Article 8 Respect for the Charter 1. All operations shall be selected and implemented while respecting the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019) and in accordance with the relevant provisions of Regulation (EU) 2021/1060. 2. In accordance with Article 69(7) of Regulation (EU) 2021/1060, Member States shall ensure the effective examination of complaints. This is without prejudice to the general possibility of citizens and stakeholders to address complaints to the Commission, including with regard to infringements of the Charter. 3. Where the Commission finds that there has been an infringement of the Charter, the Commission shall take into account the gravity of the infringement in its determination of the corrective measures to be applied in line with the relevant provisions of Regulation (EU) 2021/1060. Article 9 Partnership 1. Member States shall ensure meaningful participation of the social partners and civil society organisations in the delivery of employment, education and social inclusion policies supported by the ESF+ strand under shared management. 2. Member States shall allocate an appropriate amount of their resources of the ESF+ strand under shared management in each programme to capacity building of the social partners and civil society organisations, including in the form of training, networking measures, and strengthening of the social dialogue, and to activities jointly undertaken by the social partners. Where capacity building of the social partners and civil society organisations is identified by a relevant country-specific recommendation adopted in accordance with Article 121(2) and Article 148(4) TFEU, the Member State concerned shall allocate an appropriate amount of at least 0,25 % of its resources of the ESF+ strand under shared management for that purpose. Article 10 Support for the most deprived persons The resources referred to in Article 7(5) under specific objectives set out in Article 4(1), points (l) and (m), shall be programmed under a dedicated priority or programme. The co-financing rate for that priority or programme shall be 90 %. Article 11 Support for youth employment Support in accordance with the second and third subparagraphs of Article 7(6) shall be programmed under a dedicated priority or programme and it shall at least include support contributing to the specific objective set out in Article 4(1), point (a), and may include support contributing to the specific objectives set out in Article 4(1), points (f) and (l). Article 12 Support for relevant country-specific recommendations The actions addressing the challenges identified in relevant country-specific recommendations and in the European Semester as referred to in Article 7(2) shall be programmed under any of the specific objectives set out in Article 4(1) to support the implementation of the European Pillar of Social Rights and under one or more priorities, which can be a multi-fund priority. CHAPTER II General support from the ESF+ strand under shared management Article 13 Scope This Chapter applies to support from the ESF+ strand under shared management contributing to specific objectives set out in Article 4(1), points (a) to (l) (general support from the ESF+ strand under shared management). Article 14 Social innovative actions 1. Member States shall support actions of social innovation and social experimentation, including actions with a socio-cultural component or strengthening bottom-up approaches based on partnerships involving public authorities, the social partners, social enterprises, the private sector and civil society. 2. Member States may support the scaling up of innovative approaches tested on a small scale and developed under the EaSI strand and other Union programmes. 3. Innovative actions and approaches may be programmed under any of the specific objectives set out in Article 4(1), points (a) to (l). 4. Member States shall dedicate at least one priority to the implementation of paragraph 1 or 2, or both. The maximum co-financing rate for such priorities may be increased to 95 % for a maximum of 5 % of the national resources under the ESF+ strand under shared management. 5. Member States shall identify, either in their programmes or at a later stage during implementation, fields for social innovation and social experimentation that correspond to specific needs of Member States. 6. The Commission shall facilitate capacity building for social innovation, in particular through supporting mutual learning, establishing networks, and disseminating and promoting good practices and methodologies. Article 15 Transnational cooperation Member States may support transnational cooperation actions under any of the specific objectives set out in Article 4(1), points (a) to (l). Article 16 Eligibility 1. In addition to the non-eligible costs referred to in Article 64 of Regulation (EU) 2021/1060, the following costs shall not be eligible for general support from the ESF+ strand under shared management: (a) the purchase of land and real estate as well as infrastructure; and (b) the purchase of furniture, equipment and vehicles, except where such purchase is necessary for achieving the objective of the operation, or those items are fully depreciated during the operation, or the purchase of those items is the most economic option. 2. Contributions in kind in the form of allowances or salaries disbursed by a third party for the benefit of the participants in an operation may be eligible for a contribution from general support from the ESF+ strand under shared management provided that the contributions in kind are incurred in accordance with national rules, including accountancy rules, and do not exceed the cost borne by the third party. 3. The specific additional allocation received by the outermost regions and the NUTS level 2 regions fulfilling the criteria laid down in Article 2 of Protocol No 6 shall be used to support the achievement of the specific objectives set out in Article 4(1). 4. Direct staff costs shall be eligible for a contribution from general support from the ESF+ strand under shared management if they are in line with the beneficiary\u2019s usual remuneration practice for the category of function concerned or in line with applicable national law, collective agreements or official statistics. Article 17 Indicators and reporting 1. Programmes benefitting from general support from the ESF+ strand under shared management shall use common output and result indicators, as set out in Annex I to monitor progress in implementation. The programmes may also use programme-specific indicators. 2. Where a Member State allocates its resources to the specific objective set out in Article 4(1), point (l), to target the most deprived persons, in line with the first subparagraph of Article 7(5), the common indicators as set out in Annex II shall apply. 3. The baseline for common and programme-specific output indicators shall be set at zero. Where relevant to the nature of the operations supported, cumulative quantified milestones and target values of those indicators shall be set in absolute numbers. The reported values of the output indicators shall be expressed in absolute numbers. 4. The reference value of common and programme-specific result indicators for which a target value for 2029 have been set, shall be fixed using the latest available data or other relevant sources of information. Targets for common result indicators shall be fixed in absolute numbers or as a percentage. Programme-specific result indicators and related targets may be expressed in quantitative or qualitative terms. The reported values of common result indicators shall be expressed in absolute numbers. 5. Data on the indicators for participants shall only be transmitted when all data required under point 1.1 of Annex I relating to that participant are available. 6. Where data are available in registers or equivalent sources, Member States may enable the managing authorities and other bodies entrusted with data collection necessary for the monitoring and the evaluation of general support from the ESF+ strand under shared management to obtain data from those registers or equivalent sources, in accordance with Article 6(1), points (c) and (e), of Regulation (EU) 2016/679. 7. The Commission is empowered to adopt delegated acts in accordance with Article 37 to amend the indicators in Annexes I and II where considered necessary to ensure effective assessment of progress in the implementation of programmes. Such amendments shall be proportionate, taking into account the administrative burden borne by Member States and beneficiaries. Delegated acts in accordance with this paragraph shall not change the methodology for data collection as laid down in Annexes I and II. CHAPTER III ESF+ support for addressing material deprivation Article 18 Scope This Chapter applies to ESF+ support contributing to the specific objective set out in Article 4(1), point (m). Article 19 Principles 1. The ESF+ support for addressing material deprivation shall be used only to support the distribution of food and goods that are in conformity with the Union law on consumer product safety. 2. Member States and beneficiaries shall choose the food and/or the basic material assistance on the basis of objective criteria related to the needs of the most deprived persons. The selection criteria for the food, and where appropriate for goods, shall also take into consideration climate-related and environmental aspects, in particular with a view to reduction of food waste and single-use plastics. Where appropriate, the choice of the type of food to be distributed shall be made having considered their contribution to the balanced diet of the most deprived persons. The food and/or basic material assistance may be provided directly to the most deprived persons or indirectly, for example, through vouchers or cards, in electronic or other form, provided that they can be redeemed only against food and/or basic material assistance. Support for the most deprived persons shall be additional to any social benefit that may be provided to end recipients by national social systems or according to national law. The food provided for the most deprived persons may be obtained from the use, processing or sale of the products disposed of in accordance with Article 16(2) of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (37), provided that this is economically the most favourable option and does not unduly delay the delivery of food to the most deprived persons. Any amount derived from such a transaction shall be used for the benefit of the most deprived persons, in addition to the amounts already available to the programme. 3. The Commission and Member States shall ensure that aid provided in the framework of the ESF+ support for addressing material deprivation respects the dignity and prevents stigmatisation of the most deprived persons. 4. Member States shall complement the delivery of food and/or basic material assistance by accompanying measures, such as referrals to competent services, under the specific objective set out in Article 4(1), point (m), or by promoting the social integration of the most deprived persons under the specific objective set out in Article 4(1), point (l). Article 20 Content of the priority 1. A priority concerning support contributing to the specific objective set out in Article 4(1), point (m), shall set out: (a) the type of support; (b) the main target groups; and (c) a description of the national or regional schemes of support. 2. In the case of programmes limited to support as referred to in paragraph 1 and the related technical assistance, the priority shall also include the criteria for the selection of operations. Article 21 Eligibility of operations 1. The food and/or basic material assistance provided to the most deprived persons may be purchased by or on behalf of the beneficiary or made available free of charge to the beneficiary. 2. The food and/or basic material assistance shall be distributed free of charge to the most deprived persons. Article 22 Eligibility of expenditure 1. The eligible costs of the ESF+ support for addressing material deprivation shall be: (a) the cost of purchasing food and/or basic material assistance, including costs related to transporting food and/or basic material assistance to the beneficiaries delivering the food and/or basic material assistance to the end recipients; (b) where the transport of the food and/or basic material assistance to the beneficiaries distributing them to the end recipients is not covered by point (a), the costs borne by the purchasing body related to transporting food and/or basic material assistance to the storage depots or the beneficiaries and storage costs at a flat-rate of 1 % of the costs referred to in point (a) or, in duly justified cases, costs actually incurred and paid; (c) the administrative, transport, storage and preparation costs borne by the beneficiaries involved in the distribution of the food and/or basic material assistance to the most deprived persons at a flat-rate of 7 % of the costs referred to in point (a) or 7 % of the costs of the value of the food disposed of in accordance with Article 16 of Regulation (EU) No 1308/2013; (d) the cost of collection, transport, storage and distribution of food donations and directly related awareness raising activities; and (e) the costs of accompanying measures undertaken by or on behalf of beneficiaries and declared by the beneficiaries delivering the food and/or basic material assistance to the most deprived persons at a flat- rate of 7 % of the costs referred to in point (a). 2. Costs for the preparation of voucher or card schemes in electronic or other form, and corresponding operating costs are eligible under technical assistance provided they are borne by the managing authority or another public body which is not a beneficiary that distributes the vouchers or cards to end recipients, or provided they are not covered by the costs set out in of paragraph 1, point (c). 3. A reduction of the eligible costs referred to in paragraph 1, point (a) because the body responsible for the purchase of food and/or basic material assistance did not comply with the applicable law, shall not lead to a reduction of the eligible costs set out in points (c) and (e) of that paragraph. 4. The following costs shall not be eligible: (a) interest on debt; (b) purchase of infrastructure; and (c) costs of second-hand goods. Article 23 Indicators and reporting 1. Priorities addressing material deprivation shall use common output and result indicators, as set out in Annex III to monitor progress in implementation. Those priorities may also use programme-specific indicators. 2. The reference values of common and programme-specific result indicators shall be established. 3. Managing authorities shall report twice to the Commission the results of a structured survey of the end recipients regarding the support received from the ESF+ and also focusing on their living conditions and the nature of their material deprivation, carried out during the previous year. That survey shall be based on the model which shall be established by the Commission by means of an implementing act. The first such reporting shall take place by 30 June 2025 and the second by 30 June 2028. 4. The Commission shall adopt an implementing act establishing the model to be used for the structured survey of end recipients in accordance with the advisory procedure referred to in Article 38(2) in order to ensure uniform conditions for the implementation of this Article. 5. The Commission is empowered to adopt delegated acts in accordance with Article 37 to amend the indicators in Annex III where considered to be necessary to ensure effective assessment of progress in the implementation of programmes. Such amendments shall be proportionate taking into account the administrative burden borne by Member States and beneficiaries. Delegated acts in accordance with this paragraph shall not change the methodology for data collection as laid down in Annex III. Article 24 Audit Audit of operations may cover all stages of their implementation and all levels of the distribution chain, with the sole exception of control of the end recipients, unless a risk assessment establishes a specific risk of irregularity or fraud. PART III IMPLEMENTATION UNDER DIRECT AND INDIRECT MANAGEMENT CHAPTER I Operational objectives Article 25 Operational objectives The EaSI strand shall have the following operational objectives: (a) to develop high-quality comparative analytical knowledge in order to ensure that policies to achieve the specific objectives set out in Article 4(1) are based on sound evidence and are relevant to needs, challenges and local conditions; (b) to facilitate effective and inclusive information sharing, mutual learning, peer reviews and dialogue on policies in the policy areas set out in Article 4(1) in order to assist the design of appropriate policy measures; (c) to support social experimentation in the policy areas set out in Article 4(1) and build up the stakeholders\u2019 capacity at national and local levels to prepare, design and implement, transfer or scale up the tested social policy innovations, in particular with regard to the scaling up of projects developed by local stakeholders in the field of the socio-economic integration of third-country nationals; (d) to facilitate the voluntary geographical mobility of workers and increase employment opportunities through developing and providing specific support services to employers and jobseekers with a view to the development of integrated European labour markets, ranging from pre-recruitment preparation to post-placement assistance in order to fill vacancies in certain sectors, professions, countries, border regions or for particular groups, such as people in vulnerable situations; (e) to support the development of the market ecosystem around the provision of microfinance to microenterprises in start-up and development phases, in particular those that are created by or employ people in vulnerable situations; (f) to support networking at Union level and dialogue with and among relevant stakeholders in the policy areas set out in Article 4(1) and contribute to build up the institutional capacity of involved stakeholders, including the public employment services, public social security and health insurance institutions, civil society, microfinance institutions and institutions providing finance to social enterprises and the social economy; (g) to support the development of social enterprises and the emergence of a social investment market, facilitating public and private interactions and the participation of foundations and philanthropic actors in that market; (h) to provide guidance for the development of social infrastructure needed for the implementation of the European Pillar of Social Rights; (i) to support transnational cooperation in order to accelerate the transfer and facilitate the scaling up, of innovative solutions, in particular for the policy areas set out in Article 4(1); and (j) to support the implementation of relevant international social and labour standards in the context of harnessing globalisation and the external dimension of Union policies in the policy areas set out in Article 4(1). CHAPTER II Eligibility Article 26 Eligible actions 1. Only actions pursuing the objectives referred to in Article 3(1) and (2), Article 4(1) and Article 25 shall be eligible for funding. 2. The EaSI strand may support the following actions: (a) analytical activities, including in relation to third countries, in particular: (i) surveys, studies, statistical data, methodologies, classifications, micro-simulations, indicators and support for European-level observatories and benchmarks; (ii) social experimentation evaluating social innovations; (iii) monitoring and assessment of the transposition and application of Union law; (b) policy implementation, in particular: (i) cross-border partnerships, in particular between public employment services, the social partners and civil society, and support services in cross-border regions; (ii) a Union-wide labour-targeted mobility scheme at Union level to fill job vacancies where labour market shortcomings have been identified; (iii) support for microfinance institutions and institutions providing finance to social enterprises, including through blending operations such as asymmetric risk sharing or the reduction of transaction costs, as well as support for the development of social infrastructure and skills; (iv) support for transnational cooperation and partnership with a view to transferring and scaling up innovative solutions; (c) capacity building, in particular of: (i) networks at Union level related to the policy areas set out in Article 4(1); (ii) national contact points providing guidance, information and assistance related to the implementation of the EaSI strand; (iii) the administrations, social security institutions and employment services responsible for promoting labour mobility, of microfinance institutions and institutions providing finance to social enterprises or other social investment actors, as well as networking, in Member States or third countries associated to the EaSI strand pursuant to Article 29; (iv) stakeholders, including the social partners and civil society organisations, in view of transnational cooperation; (d) communication and dissemination activities, in particular: (i) mutual learning through exchange of good practices, innovative approaches, results of analytical activities, peer reviews, and benchmarking; (ii) guides, reports, informative material and media coverage of initiatives related to the policy areas set out in Article 4(1); (iii) information systems disseminating evidence related to the policy areas set out in Article 4(1); (iv) events of the Presidency of the Council and conferences, seminars and awareness-raising activities. Article 27 Eligible entities 1. Subject to the criteria set out in Article 197 of the Financial Regulation, the following entities shall be eligible: (a) legal entities established in any of the following countries or territories: (i) a Member State or an overseas country or territory linked to it; (ii) a third country which is associated to the EaSI strand pursuant to Article 29; (iii) a third country listed in the work programme, subject to conditions specified in paragraphs 2 and 3 of this Article; (b) any legal entity established under Union law or any international organisation. 2. Legal entities established in a third country which is not associated to the EaSI strand pursuant to Article 29 shall be exceptionally eligible to participate where necessary for the achievement of the objectives of a given action. 3. Legal entities established in a third country which is not associated to the EaSI strand pursuant to Article 29 shall, in principle, bear the cost of their participation. Article 28 Horizontal principles 1. The Commission shall ensure that gender equality, gender mainstreaming and the integration of gender perspective are taken into account and promoted throughout the preparation, implementation, monitoring, reporting, and evaluation of the operations supported from the EaSI strand. 2. The Commission shall take appropriate steps to prevent any discrimination based on gender, racial or ethnic origin, religion or belief, disability, age or sexual orientation during the preparation, implementation, monitoring, reporting, and evaluation of the operations supported from the EaSI strand. In particular, accessibility for persons with disabilities shall be taken into account throughout the preparation and implementation of the EaSI strand. Article 29 Participation of third countries The EaSI strand shall be open to the participation of the following third countries by means of an agreement with the Union: (a) members of the European Free Trade Association which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country in the EaSI strand, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes or strands of programmes, and their administrative costs; (iii) does not confer to the third country a decisional power on the EaSI strand; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. The contributions referred to in this Article, first paragraph, point (c)(ii), shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. CHAPTER III General provisions Article 30 Forms of Union funding and methods of implementation 1. The EaSI strand may provide funding in any of the forms laid down in the Financial Regulation for financial contributions, in particular grants, prizes, procurement and voluntary payments to international organisations of which the Union is a member or in whose work it participates. 2. The EaSI strand shall be implemented directly as provided for in Article 62(1), first subparagraph, point (a), of the Financial Regulation or indirectly with bodies referred to in Article 62(1), first subparagraph, point (c), of that Regulation. When awarding grants, the evaluation committee referred to in Article 150 of the Financial Regulation may be composed of external experts. 3. Blending operations under the EaSI strand shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. Article 31 Work programme 1. The EaSI strand shall be implemented on the basis of work programmes referred to in Article 110 of Financial Regulation. The content of those work programmes shall be established in line with the operational objectives set out in Article 25 of this Regulation and with the eligible actions set out in Article 26 of this Regulation. Work programmes shall set out, where applicable, the overall amount reserved for blending operations. 2. The Commission shall gather expertise on the preparation of the work programmes by consulting the working group referred to in Article 39(8). 3. The Commission shall foster synergies and ensure effective coordination between ESF+ and other relevant Union instruments as well as between the ESF+ strands. Article 32 Monitoring and reporting Indicators to report on the progress of the EaSI strand towards the achievement of the specific objectives set out in Article 4(1) and the operational objectives set out in Article 25 are set out in Annex IV. The performance reporting system shall ensure that data for monitoring the implementation and results of the EaSI strand are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where relevant, Member States. Article 33 Protection of the financial interests of the Union Where a third country participates in the EaSI strand by means of a decision adopted pursuant to an international agreement, or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 34 Evaluation 1. Evaluations shall be carried out in a timely manner to feed into the decision-making process. 2. By 31 December 2024, the Commission shall carry out a mid-term evaluation of the EaSI strand, on the basis of sufficient information available about its implementation. The Commission shall assess the performance of the programme pursuant to Article 34 of the Financial Regulation, and in particular its effectiveness, efficiency, coherence, relevance and Union added value, including vis-\u00e0-vis the horizontal principles referred to in Article 28 of this Regulation, and measure, on a qualitative and quantitative basis, progress made in meeting the objectives of the EaSI strand. The mid-term evaluation shall be based on the information generated by the monitoring arrangements and indicators established pursuant to Article 32, with a view to making any adjustments needed to the policy and funding priorities. 3. By 31 December 2031, at the end of the implementation period a final evaluation of the EaSI strand shall be carried out by the Commission. 4. The Commission shall submit the conclusions of the mid-term and final evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 35 Audits Audits on the use of the Union contribution carried out by persons or entities, including by other than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. Article 36 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the EaSI strand, to actions taken pursuant to the EaSI strand and to the results obtained. Financial resources allocated to the EaSI strand shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3(1) and (2), Article 4(1) and Article 25. PART IV FINAL PROVISIONS Article 37 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 17(7) and Article 23(5) shall be conferred on the Commission for an indeterminate period of time from 1 July 2021. 3. The delegation of power referred to in Article 17(7) and Article 23(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 17(7) or Article 23(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 38 Committee procedure for the ESF+ strand under shared management 1. The Commission shall be assisted by the committee referred to in Article 115(1) of Regulation (EU) 2021/1060. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 39 Committee set up under Article 163 TFEU 1. The Commission shall be assisted by the Committee set up under Article 163 TFEU (the \u2018ESF+ Committee\u2019). 2. Each Member State shall appoint one government representative, one representative of the workers\u2019 organisations, one representative of the employers\u2019 organisations and one alternate for each member for a maximum period of seven years. In the absence of a member, the alternate shall be automatically entitled to take part in the proceedings. 3. The ESF+ Committee shall include one representative from each of the organisations representing workers\u2019 organisations and employers\u2019 organisations at Union level. 4. The ESF+ Committee, including its working groups referred to in paragraph 7, may invite non-voting representatives of stakeholders to attend its meetings. This may include representatives of the European Investment Bank and the European Investment Fund as well as relevant civil society organisations. 5. The ESF+ Committee shall be consulted on the planned use of technical assistance referred to in Article 35 of Regulation (EU) 2021/1060 in the case of support from the ESF+ strand under shared management, as well as on other issues having an impact on the implementation of strategies at Union level relevant to the ESF+. 6. The ESF+ Committee may deliver opinions on: (a) questions related to the ESF+ contribution to the implementation of the European Pillar of Social Rights, including country-specific recommendations and European Semester-related priorities, such as national reform programmes; (b) issues concerning Regulation (EU) 2021/1060 relevant for the ESF+; (c) questions related to the ESF+ referred to it by the Commission other than those referred to in paragraph 5. The opinions of the ESF+ Committee shall be adopted by an absolute majority of the votes validly cast, and shall be communicated to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, for information. The Commission shall inform the ESF+ Committee in writing of the manner in which it has taken account of its opinions. 7. The ESF+ Committee shall set up working groups for each ESF+ strand. 8. The Commission shall consult the working group dealing with the EaSI strand on the work programme. It shall inform that working group of the manner in which it has taken account of the results of that consultation. That working group shall ensure that a consultation of the work programme with stakeholders, including with representatives of civil society, takes place. Article 40 Transitional provisions for the ESF+ strand under shared management Regulation (EU) No 1304/2013, Regulation (EU) No 223/2014 or any act adopted under those Regulations shall continue to apply to programmes and operations supported under those Regulations during the 2014 to 2020 programming period. Article 41 Transitional provisions for the EaSI strand 1. Regulation (EU) No 1296/2013 is repealed with effect from 1 January 2021. Any references to Regulation (EU) No 1296/2013 shall be construed as references to this Regulation. 2. The financial envelope for the implementation of the EaSI strand may also cover technical and administrative assistance expenses necessary to ensure the transition between the ESF+ and the measures adopted pursuant to Regulation (EU) No 1296/2013. 3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 5(4), to enable the management of actions not completed by 31 December 2027. 4. Repayments from financial instruments established by Regulation (EU) No 1296/2013 shall be invested in the financial instruments of the social investment and skills policy window referred to in Article 8(1), point (d), of Regulation (EU) 2021/523. 5. In accordance with Article 193(2), second subparagraph, point (a), of the Financial Regulation, in duly justified cases specified in the financing decision and for a limited period, activities supported under this Regulation and the underlying costs may be considered eligible as of 1 January 2021, even if they were implemented and incurred before the grant application was submitted. Article 42 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021 with regard to the EaSI strand. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 June 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 429, 11.12.2020, p. 245. (2) OJ C 86, 7.3.2019, p. 84. (3) Position of the European Parliament of 16 January 2019 (OJ C 411, 27.11.2020, p. 324) and position of the Council at first reading of 27 May 2021 (not yet published in the Official Journal). Position of the European Parliament of 23 June 2021 (not yet published in the Official Journal). (4) Regulation (EU) 2021/1058 of the European Parliament and of the Council of 24 June 2021 on the European Regional Development Fund and on the Cohesion Fund (see page 60 of this Official Journal). (5) Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, p. 487). (6) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (7) Council Decision (EU) 2020/1512 of 13 October 2020 on guidelines for the employment policies of the Member States (OJ L 344, 19.10.2020, p. 22). (8) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (see page 159 of this Official Journal). (9) Regulation (EU) 2021/1056 of the European Parliament and of the Council of 24 June 2021 establishing the Just Transition Fund (see page 1 of this Official Journal). (10) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (11) Regulation (EU) No 223/2014 of the European Parliament and of the Council of 11 March 2014 on the Fund for European Aid to the Most Deprived (OJ L 72, 12.3.2014, p. 1). (12) Regulation (EU) No 1296/2013 of the European Parliament and of the Council of 11 December 2013 on a European Union Programme for Employment and Social Innovation (\u2018EaSI\u2019) and amending Decision No 283/2010/EU establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 347, 20.12.2013, p. 238). (13) OJ L 433 I, 22.12.2020, p. 28. (14) Regulation (EU) 2021/817 of the European Parliament and of the Council of 20 May 2021 establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 (OJ L 189, 28.5.2021, p. 1). (15) Council Recommendation of 19 December 2016 on Upskilling Pathways: New Opportunities for Adults (OJ C 484, 24.12.2016, p. 1). (16) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (17) Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union\u2019s action in the field of health (\u2018EU4Health Programme\u2019) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1). (18) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17). (19) Regulation (EU) 2021/691 of the European Parliament and of the Council of 28 April 2021 on the European Globalisation Adjustment Fund for Displaced Workers (EGF) and repealing Regulation (EU) No 1309/2013 (OJ L 153, 3.5.2021, p. 48). (20) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, p. 1). (21) Regulation (EU) 2021/818 of the European Parliament and of the Council of 20 May 2021 establishing the Creative Europe Programme (2021 to 2027) and repealing Regulation (EU) No 1295/2013 (OJ L 189, 28.5.2021, p. 34). (22) Regulation (EU) 2021/888 of the European Parliament and of the Council of 20 May 2021 establishing the European Solidarity Corps Programme and repealing Regulations (EU) 2018/1475 and (EU) No 375/2014 (OJ L 202, 8.6.2021, p. 32). (23) Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (OJ L 57, 18.2.2021, p. 1). (24) Regulation (EU) No 1304/2013 of the European Parliament and of the Council of 17 December 2013 on the European Social Fund and repealing Council Regulation (EC) No 1081/2006 (OJ L 347, 20.12.2013, p. 470). (25) OJ C 241, 29.8.1994, p. 9. (26) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (27) OJ L 282, 19.10.2016, p. 4. (28) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (\u2018Overseas Association Decision\u2019) (OJ L 344, 19.12.2013, p. 1). (29) OJ L 1, 3.1.1994, p. 3. (30) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (31) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (32) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (33) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (34) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (35) OJ L 123, 12.5.2016, p. 1. (36) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (37) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). ANNEX I COMMON INDICATORS FOR GENERAL SUPPORT FROM THE ESF+ STRAND UNDER SHARED MANAGEMENT Personal data are to be broken down by gender (women, men, non-binary persons (1)). If certain results are not possible, data for those results do not have to be collected or reported. Where appropriate, common output indicators can be reported based on the target group of the operation. 1. Common output indicators related to operations targeting people 1.1. Common output indicators for participants are: \u2014 unemployed, including long-term unemployed (*1), \u2014 long-term unemployed (*1), \u2014 inactive (*1), \u2014 employed, including self-employed (*1), \u2014 number of children below 18 years of age (*1), \u2014 young people between 18 and 29 years of age (*1), \u2014 number of participants of 55 years of age and above (*1), \u2014 with lower secondary education or less (ISCED 0-2) (*1), \u2014 with upper secondary (ISCED 3) or post-secondary education (ISCED 4) (*1), \u2014 with tertiary education (ISCED 5 to 8) (*1), \u2014 total number of participants (2). Indicators listed under this point do not apply to ESF+ support contributing to the specific objective set out in Article 4(1), point (l), except the following indicators: \u2018number of children below 18 years of age\u2019, \u2018young people between 18 and 29 years of age\u2019, \u2018number of participants of 55 years of age and above\u2019 and \u2018total number of participants\u2019. Where data are collected from registers or equivalent sources, Member States may use national definitions. 1.2. Other common output indicators for participants are: \u2014 participants with disabilities (*2), \u2014 third-country nationals (*1), \u2014 participants with a foreign background (*1), \u2014 minorities (including marginalised communities, such as Roma people) (*2), \u2014 homeless or affected by housing exclusion (*1), \u2014 participants from rural areas (*1) (3). Data collection is necessary only where applicable and relevant. Values of the indicators listed under point 1.2 can be determined based on informed estimates provided by the beneficiary. For indicators listed under point 1.2 Member States may apply national definitions, except for the following indicators: \u2018third-country nationals\u2019 and \u2018participants from rural areas\u2019. 2. Common output indicators for entities Common output indicators for entities are: \u2014 number of supported public administrations or public services at national, regional or local level, \u2014 number of supported micro, small and medium-sized enterprises (including cooperative enterprises and social enterprises). Where data are collected from registers or equivalent sources, Member States may use national definitions. 3. The common immediate result indicators for participants The common immediate result indicators for participants are: \u2014 participants engaged in job searching upon leaving (*1), \u2014 participants in education or training upon leaving (*1), \u2014 participants gaining a qualification upon leaving (*1), \u2014 participants in employment, including self-employment, upon leaving (*1). Indicators listed under this point do not apply to ESF+ support contributing to the specific objective set out in Article 4(1), point (l). Where data are collected from registers or equivalent sources, Member States may use national definitions. 4. Common longer-term result indicators for participants Common longer-term result indicators for participants are: \u2014 participants in employment, including self-employment, six months after leaving (*1), \u2014 participants with an improved labour market situation six months after leaving (*1). Indicators listed under this point do not apply to ESF+ support contributing to the specific objective set out in Article 4(1), point (l). Where data are collected from registers or equivalent sources, Member States may use national definitions. Common longer-term result indicators for participants shall be reported by 31 January 2026 in accordance with Article 42(1) of Regulation (EU) 2021/1060 and in the final performance report referred to in Article 43 of that Regulation. As a minimum requirement, common longer-term indicators for participants shall be based on a representative sample of participants within the specific objectives set out in Article 4(1), points (a) to (k). Internal validity of the sample is to be ensured in such a way that the data can be generalised at the level of the specific objective. (1) According to national law. (*1) Data reported are personal data according to Article 4(1) of Regulation (EU) 2016/679. (2) This indicator shall be calculated automatically on the basis of the common output indicators relating to employment status, except for ESF+ support contributing to the specific objective set out in Article 4(1), point (l), in which case the total number of participants is to be reported. (*2) Data reported comprise a special category of personal data as referred to in Article 9 of Regulation (EU) 2016/679. (3) This indicator does not apply to ESF+ support contributing to the specific objective set out in Article 4(1), point (l). ANNEX II COMMON INDICATORS FOR THE ESF+ ACTIONS TARGETING SOCIAL INCLUSION OF THE MOST DEPRIVED PERSONS WITHIN THE SPECIFIC OBJECTIVE SET OUT IN ARTICLE 4(1), POINT (L), IN LINE WITH THE FIRST SUBPARAGRAPH OF ARTICLE 7(5) Personal data are to be broken down by gender (women, men, non-binary persons (1)). 1. Common output indicators related to operations targeting people 1.1. Common output indicators for participants are: \u2014 total number of participants, \u2014 number of children below 18 years of age (*1), \u2014 number of young people between 18 and 29 years of age (*1), \u2014 number of participants of 65 years of age and above (*1). Values of the indicators listed under point 1.1 can be determined based on informed estimates provided by the beneficiary. 1.2. Other common output indicators are: \u2014 participants with disabilities (*2), \u2014 third-country nationals (*1), \u2014 number of participants with a foreign background (*1), minorities (including marginalised communities, such as Roma people) (*2), \u2014 homeless or affected by housing exclusion (*1). Data collection is necessary only where applicable and relevant. Values of the indicators listed under point 1.2 can be determined based on informed estimates provided by the beneficiary. (1) According to national law. (*1) Data reported are personal data according to Article 4(1) of Regulation (EU) 2016/679. (*2) Data reported comprise a special category of personal data as referred to in Article 9 of Regulation (EU) 2016/679. ANNEX III COMMON INDICATORS FOR ESF+ SUPPORT FOR ADDRESSING MATERIAL DEPRIVATION 1. Output indicators 1.1. Total monetary value of distributed food and goods: 1.1.1. total value of the food support (1); 1.1.1.1. total monetary value of food for the homeless; 1.1.1.2. total monetary value of food for other target groups; 1.1.2. total value of goods distributed (2); 1.1.2.1. total monetary value of goods for children; 1.1.2.2. total monetary value of goods for the homeless; 1.1.2.3. total monetary value of goods for other target groups. 1.2. Total quantity of food support distributed (in tonnes) (3): 1.2.1. share of food for which only transport, distribution and storage were paid for by the programme (in %); 1.2.2. proportion of the ESF+ co-financed food in the total volume of food distributed the beneficiaries (in %). Values of the indicators listed under points 1.2.1 and 1.2.2 shall be determined based on informed estimates provided by the beneficiary. 2. Common result indicators 2.1. Number of the end recipients receiving food support \u2014 number of children below 18 years of age, \u2014 number of young people between 18 and 29 years of age, \u2014 number of women, \u2014 number of end recipients of 65 years of age and above, \u2014 number of end recipients with disabilities (*1), \u2014 number of third-country nationals (*1), \u2014 number of end recipients with a foreign background and minorities (including marginalised communities such as Roma people) (*1), \u2014 number of homeless end recipients or end-recipients affected by housing exclusion (*1). 2.2. Number of the end recipients receiving material support \u2014 number of children below 18 years of age, \u2014 number of young people between 18 and 29 years of age, \u2014 number of women, \u2014 number of end recipients of 65 years of age and above, \u2014 number of end recipients with disabilities (*1), \u2014 number of third-country nationals (*1), \u2014 number of end recipients with a foreign background and minorities (including marginalised communities, such as Roma people) (*1), \u2014 number of homeless end recipients or end-recipients affected by housing exclusion (*1). 2.3. Number of the end recipients benefiting from vouchers or cards \u2014 number of children below 18 years of age, \u2014 number of young people between 18 and 29 years of age, \u2014 number of end recipients of 65 years of age and above, \u2014 number of women, \u2014 number of end recipients with disabilities (*1), \u2014 number of third-country nationals (*1), \u2014 number of end recipients with a foreign background and minorities (including marginalised communities, such as Roma people) (*1), \u2014 number of homeless end recipients or end recipients affected by housing exclusion (*1). Values of the indicators listed under point 2 shall be determined based on informed estimates provided by the beneficiary. (1) These indicators do not apply to food assistance provided indirectly through vouchers or cards. (2) These indicators do not apply to goods provided indirectly through vouchers or cards. (3) These indicators do not apply to food assistance provided indirectly through vouchers or cards. (*1) National definitions may be used. ANNEX IV INDICATORS FOR THE EaSI STRAND Indicators for the EaSI strand \u2014 number of analytical activities, \u2014 number of information sharing and mutual learning activities, \u2014 number of social experimentation, \u2014 number of capacity building and networking activities, \u2014 number of job placements under targeted mobility schemes. Data for the indicator \u2018number of job placements under targeted mobility schemes\u2019 shall be collected only every two years.", "summary": "European Social Fund Plus \u2014 ESF+ (2021-2027) European Social Fund Plus \u2014 ESF+ (2021-2027) SUMMARY OF: Regulation (EU) 2021/1057 establishing the European Social Fund Plus (ESF+) WHAT IS THE AIM OF THE REGULATION? The Regulation establishes the European Social Fund Plus (ESF+) and lays down the fund\u2019s objectives, its budget for 2021-2027, the methods of implementation, the forms of European Union (EU) funding and the rules for providing such funding. KEY POINTS The ESF+ integrates the former European Social Fund, the youth employment initiative, the Fund for European Aid to the Most Deprived and the EU programme for employment and social innovation. Strands The ESF+ consists of 2 strands: the shared management* strand; and the employment and social innovation (EaSI) strand under direct* and indirect management*. Objectives The ESF+ has 2 general objectives. To help EU Member States and regions achieve high employment levels, fair social protection and a skilled and resilient workforce ready for the future, as well as inclusive and fair societies that aim to eradicate poverty and deliver on the principles set out in the European Pillar of Social Rights. To support, complement and add value to the policies of Member States to ensure equal opportunities, equal access to the labour market, fair and quality working conditions, social protection and inclusion. Priority areas The ESF+ will focus on a number of priority areas, including: supporting young people who have been particularly affected by the socioeconomic crisis triggered by the COVID-19 pandemic by providing resources to help them get a qualification, a quality job and improve their education and skills; helping children in need by allocating resources to targeted actions aimed at combating child poverty and supporting the most vulnerable in society suffering from job losses and income reductions, including with the provision of food and basic material assistance to the most deprived; reskilling and upskilling people for the transition to a green and digital economy and improving the quality of education and training systems; promoting gender equality, equal opportunities and non-discrimination; building capacity for social partners and civil-society organisations; promoting social innovation across the EU through transnational cooperation; providing direct support to social innovation through the EaSI strand. Allocation of resources The regulation includes certain minimum requirements for the allocation of ESF+ shared management resources by Member States: at least 25% to foster social inclusion; at least 3% to support the most deprived persons; Member States whose average rate of children at risk of poverty or social exclusion for 2017-2019 was above the EU average must allocate at least 5% of their resources to tackling child poverty; Member States whose average rate of young people aged 15-29 not in employment, education or training in 2017-2019 was above the EU average must allocate at least 12.5% of their resources to targeted actions and structural reforms to support youth employment, vocational education and training, in particular apprenticeships, and the transition from school to work, pathways to reintegrate into education or training and second chance education, in particular in the context of implementing schemes under the youth guarantee. Budget and management The ESF+ has a budget of just under \u20ac88 billion (2018 prices) for 2021-2027. The majority of funding (\u20ac87.3 billion in 2018 prices) under the ESF+ is allocated under the shared management strand with the Member States. The ESF+ managing authorities in each Member State will dispense the money to relevant projects run by a range of public and private organisations. The European Commission directly manages a smaller share (around \u20ac676 million in 2018 prices) under the EaSI strand. To accelerate the transfer and facilitate the scaling up of innovative solutions, \u20ac175 million are allocated for transnational cooperation. Common EU rules on the management of funds, applicable to all cohesion policy funds, are set out in Regulation (EU) 2021/1060 (see summary). FROM WHEN DOES THE REGULATION APPLY? It has applied partially, for the EaSI strand, since 1 January 2021, and fully since 1 July 2021. BACKGROUND For more information, see: European Social Fund Plus (European Commission). KEY TERMS Shared management: the EU entrusts the Member States with implementing programmes at the national or the regional level. The Member States\u2019 administrations (at national, regional and local levels) choose which projects to finance and are responsible for their day-to-day management. The Member State is primarily responsible for setting up a management and control system and for preventing, detecting and correcting irregularities. Working together with the Member States, the Commission makes sure that the projects are successfully concluded, and that the money is well spent. Direct management: the European Commission launches the calls for proposals to award grants to projects and calls for tenders to award service and/or supply contracts. Indirect management: a managing authority is chosen by the European Commission to manage the project concerned on its behalf. MAIN DOCUMENT Regulation (EU) 2021/1057 of the European Parliament and of the Council of 24 June 2021 establishing the European Social Fund Plus (ESF+) and repealing Regulation (EU) No 1296/2013 (OJ L 231, 30.6.2021, pp. 21-59) RELATED DOCUMENTS Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, pp. 159-706) last update 04.08.2021"}
{"article": "8.6.2021 EN Official Journal of the European Union L 202/32 REGULATION (EU) 2021/888 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 May 2021 establishing the European Solidarity Corps Programme and repealing Regulations (EU) 2018/1475 and (EU) No 375/2014 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 165(4), 166(4) and 214(5) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Union is built on solidarity, both among its citizens and among the Member States. That universal and common value guides the actions of the Union and provides the unity necessary to cope with current and future societal challenges, which young Europeans are willing to help address by expressing their solidarity in practice. Article 2 of the Treaty on European Union (TEU) highlights solidarity as one of the principles key to the Union. The principle of solidarity is also referred to in Article 21(1) TEU as one of the foundations of the Union\u2019s external action. (2) Given the significant increase in global humanitarian needs and with a view to enhancing the promotion of solidarity and the visibility of humanitarian aid among Union citizens, there is a need to develop solidarity between Member States and with third countries affected by man-made or natural disasters. (3) Humanitarian aid volunteering actions should contribute to a needs-based humanitarian response and be guided by the European Consensus on Humanitarian Aid set out in the Joint Statement by the Council and the Representatives of the Governments of the Member States meeting within the Council, the European Parliament and the European Commission entitled \u2018The European Consensus on Humanitarian Aid\u2019 (4). International humanitarian law and human rights law should be promoted. (4) Where appropriate, the central and overall coordinating role of the United Nations (UN) Office for the Coordination of Humanitarian Affairs in promoting a coherent international response to humanitarian crises should be taken into account. (5) Humanitarian aid volunteering actions should contribute to an adequate humanitarian response that strengthens the gender perspective in Union humanitarian aid policy and promotes adequate humanitarian responses to the specific needs of women and men of all ages. Humanitarian aid volunteering actions should take into account the needs and capacities of people in the most vulnerable situations, including women and children, and people most at risk. (6) Humanitarian aid volunteering actions should strive to contribute to enhancing the effectiveness and efficiency of Union humanitarian aid, in line with the Good Humanitarian Donorship principles. (7) The State of the Union address of 14 September 2016 emphasised the need to invest in young people and announced the establishment of a European Solidarity Corps with a view to creating opportunities for young people across the Union to make a meaningful contribution to society, show solidarity and develop their skills, enabling them to obtain not only work experience but also an invaluable human experience. (8) In its communication of 7 December 2016 entitled \u2018A European Solidarity Corps\u2019, the Commission emphasised the need to strengthen the foundations for solidarity work across Europe, to provide young people with more and better opportunities for solidarity activities covering a broad range of areas, and to support national, regional and local actors in their efforts to cope with different challenges and crises. That communication launched a first phase of the European Solidarity Corps whereby resources under different Union programmes were mobilised to offer volunteering, traineeship or job opportunities to young people across the Union. (9) Within the context of this Regulation, \u2018solidarity\u2019 is understood as a sense of individual and collective responsibility for the common good, expressed through concrete action. (10) Contributing assistance to people and communities outside the Union that are in need of humanitarian aid, based on the fundamental principles of humanity, neutrality, impartiality and independence, is an important expression of solidarity. (11) There is a need to further develop solidarity with victims of crises and disasters in third countries and to raise both the awareness and the visibility of humanitarian aid, and volunteering in general, as a lifelong activity among Union citizens. (12) The Union and the Member States have committed to implementing the UN 2030 Agenda for Sustainable Development and the Sustainable Development Goals thereof, both internally and through external actions. (13) In its conclusions of 19 May 2017 on operationalising the humanitarian-development nexus, the Council recognised the need to strengthen resilience by better linking humanitarian assistance and development cooperation and to further strengthen the operational links between the complementary approaches of humanitarian assistance, development cooperation and conflict prevention. (14) Young people should be provided with easily accessible and inclusive opportunities to engage in solidarity activities, which could enable them to express their commitment to benefitting communities while acquiring useful experience, knowledge, skills and competences for their personal, educational, social, civic and professional development, thereby improving their employability. Those solidarity activities should also support the mobility of young volunteers, intercultural awareness and intercultural dialogue. (15) The solidarity activities offered to young people should allow for concrete and beneficial contributions of young people. Solidarity activities should respond to unmet societal needs and contribute to strengthening communities and civic participation. Solidarity activities should offer young people the opportunity to acquire valuable knowledge, skills and competences. Solidarity activities should be financially accessible to young people and be carried out in safe and healthy conditions. (16) The European Solidarity Corps Programme (the \u2018Programme\u2019) provides a single entry point for solidarity activities throughout the Union and beyond. In order to maximise the effectiveness of Union funding and the impact of the Programme, the Commission should seek to establish synergies across all relevant programmes in a coherent manner, but without such synergies leading to funds being used to pursue objectives other than those set out in this Regulation. Consistency and complementarity should be ensured with other relevant Union policies, such as the European Union Youth Strategy 2019-2027 (5), and other relevant Union programmes, in particular the Erasmus+ Programme, established by Regulation (EU) 2021/817 of the European Parliament and of the Council (6). The Programme is built on the strengths and synergies of previous and existing programmes, in particular the European Voluntary Service, established by Regulation (EU) No 1288/2013 of the European Parliament and of the Council (7), and the EU Aid Volunteers initiative, established by Regulation (EU) No 375/2014 of the European Parliament and of the Council (8). Complementarity with existing Union-level networks pertinent to Programme activities, such as the Eurodesk network, should also be ensured. Furthermore, complementarity between existing related schemes, in particular national solidarity schemes, such as volunteering, civic service, and mobility schemes for young people, and the Programme should be ensured to mutually enhance and enrich the impact and qualities of such schemes and, where appropriate, to build upon good practices. The Programme should not be a substitute for similar national schemes. Equal access for all young people to national solidarity activities should be ensured. (17) In order to align its duration with that of the multiannual financial framework for the period from 1 January 2021 to 31 December 2027 (the \u20182021-2027 MFF\u2019) laid down in Council Regulation (EU, Euratom) 2020/2093 (9), the Programme should be established for a period of seven years. (18) With respect to the interpretation of related legal acts of the Union, it is appropriate that both cross-border volunteering and volunteering that continues to be supported under Regulation (EU) No 1288/2013 be considered equivalent to volunteering undertaken under the European Voluntary Service. (19) The Programme is designed to open up new opportunities for young people to undertake volunteering activities in solidarity-related areas, as well as to devise and develop solidarity projects based on their own initiative. Those opportunities contribute to enhancing the personal, educational, social, civic and professional development of young people. The Programme should also support networking activities for participants and participating organisations and measures to ensure the quality of the supported activities and to enhance the validation of the learning outcomes of participants. The Programme thereby also aims to contribute to European cooperation relevant to young people and to raising awareness of its positive impact. It is appropriate that solidarity activities offered follow a clear and detailed procedure addressed to participants and participating organisations, establishing the steps of all phases of the solidarity activities. (20) Solidarity activities should present potential European added value and should benefit communities and foster participants\u2019 personal, educational, social, civic and professional development. Solidarity activities should be developed in relation to different areas, such as: education and training; youth work; employment; gender equality; entrepreneurship and, in particular, social entrepreneurship; citizenship and democratic participation; intercultural awareness and intercultural dialogue; social inclusion; inclusion of people with disabilities; environment and nature protection; climate action; disaster prevention, preparedness and recovery; agriculture and rural development; the provision of food and non-food items; health and wellbeing; culture, including cultural heritage; creativity; physical education and sport; social assistance and welfare; the reception and integration of third-country nationals, taking into account the challenges faced by people with a migrant background; territorial cooperation and cohesion; and cooperation across borders. Solidarity activities should include a solid learning and training dimension through relevant activities that are offered to participants before, during and after the solidarity activity. (21) Volunteering, both within and beyond the Union, constitutes a rich experience in a non-formal and informal learning context and enhances young people\u2019s personal, socio-educational and professional development, active citizenship, civic participation and employability. Volunteering should not have an adverse effect on potential or existing paid employment and it should not be considered a substitute for it. The Commission and the Member States should cooperate regarding volunteering policies in the youth field via the open method of coordination. (22) Young people\u2019s spirit of initiative is an important asset for society and for the labour market. The Programme contributes to fostering that spirit of initiative by offering young people the opportunity to devise and implement their own solidarity projects with the aim of addressing specific challenges to the benefit of their local communities. Solidarity projects are an opportunity to try out ideas concerning, and innovative solutions to, common challenges through a bottom-up approach and they support young people to be drivers of solidarity actions themselves. Solidarity projects also serve as a springboard for further engagement in solidarity activities and are a first step towards encouraging participants to engage in self-employment and to continue to be active citizens as volunteers, trainees or employees in associations, non-governmental organisations or other bodies active in the solidarity, non-profit and youth sectors. (23) Participants in volunteering (\u2018volunteers\u2019) can contribute to strengthening the Union\u2019s capacity to provide needs-based and principled humanitarian aid and can contribute to enhancing the effectiveness of the humanitarian sector provided that they are adequately selected, trained and prepared for deployment so as to ensure that they have the necessary skills and competences to help people in need in the most effective way and provided that they can count on sufficient on-site support and supervision. Therefore, highly skilled, highly trained and experienced coaches, mentors and experts play an important role in contributing to the effectiveness of the humanitarian response on the ground as well as towards supporting volunteers as part of the volunteering. Such coaches, mentors and experts can be involved in volunteering in order to guide and accompany volunteers and help to support the development and capacity-building components of the volunteering, thereby strengthening local networks and communities. Particular attention should be paid to the capacity of hosting organisations in third countries and the need to embed the volunteering within the local context and to facilitate volunteers\u2019 interaction with local humanitarian actors, the hosting community and civil society. (24) It is important that participants and participating organisations feel that they belong to a community of individuals and entities committed to enhancing solidarity across Europe. At the same time, participating organisations need support to strengthen their capacity to offer good quality solidarity activities to an increasing number of participants. The Programme should support networking activities that aim to strengthen the engagement of participants and of participating organisations in such a community, to foster a Programme spirit and to encourage the exchange of useful practices and experience. Networking activities should also contribute to raising awareness about the Programme among public and private actors and to facilitating the collection of feedback from participants and participating organisations on the implementation of the Programme. (25) Particular attention should be paid to ensuring the quality of solidarity activities and the opportunities offered under the Programme, in particular by offering online or offline training, language support and administrative support to participants before, during and after the solidarity activity in question, as well as insurance, including coverage for accidents, sickness and third-party liability. The validation of the knowledge, skills and competences acquired by participants through their experience under the Programme should be ensured. The security and safety of the participants, participating organisations and intended beneficiaries remains of paramount importance. Such security and safety should include appropriate clearance requirements for participants working with vulnerable groups in accordance with applicable national law. All solidarity activities should comply with the \u2018do no harm\u2019 principle and should be implemented with due consideration for the impact of unforeseen circumstances such as environmental crises, conflicts or pandemics. Volunteers should not be deployed in operations conducted in areas of international and non-international armed conflicts or in facilities that contravene international human rights standards. (26) The Programme should respect the principles set out in the 2017 EU Guidelines for the Promotion and Protection of the Rights of the Child and in Article 9 of the UN Convention on the Rights of Persons with Disabilities. (27) To ensure the impact of Programme activities on the personal, educational, social, cultural, civic and professional development of the participants, the knowledge, skills and competences that constitute the learning outcomes of the activity in question should be properly identified and documented. To that end, the use of effective instruments at Union and national level for the recognition of non-formal and informal learning, such as Youthpass and Europass, should be encouraged, as appropriate, in accordance with national circumstances and specificities, as recommended in the Council Recommendation of 20 December 2012 (10). (28) The Commission and the national agencies should also encourage former participants to share their experiences through youth networks, educational establishments and workshops in roles such as ambassadors or as members of a network. Former participants could also contribute to the training of participants. (29) A quality label should ensure that participating organisations comply with the principles and requirements of the Programme as regards their rights and responsibilities during all stages of the solidarity experience. (30) Any entity that wishes to participate in the Programme should receive a quality label provided that it complies with appropriate conditions. The Programme implementing bodies should conduct the process that leads to the attribution of a quality label on a continuous basis. The Programme implementing bodies should periodically reassess whether entities continue to comply with the conditions that led to the attribution of their quality labels. A quality label should be revoked where it is found, in the context of the checks performed by the Programme implementing bodies, that the entity in question no longer complies with those conditions. The administrative process for the attribution of a quality label should be reduced to a minimum in order to avoid discouraging smaller organisations. (31) An entity that wishes to apply for funding to offer solidarity activities under the Programme should first receive a quality label. Such a precondition should not apply to natural persons seeking financial support on behalf of an informal group of participants for their solidarity projects. Obtaining a quality label, however, should not automatically lead to funding under the Programme. (32) As a general rule, grant applications should be submitted to the national agency of the country in which the participating organisation is based. Grant applications for activities with a Union-wide or international dimension, including solidarity activities of volunteering teams in priority areas identified at Union level and solidarity activities in support of humanitarian aid operations in third countries, may be centrally managed if appropriate. (33) Participating organisations may perform several functions in the framework of the Programme. In a host capacity, participating organisations should carry out activities in relation to receiving participants, including organising activities and providing guidance and support to participants during the solidarity activity, as appropriate. In a support capacity, they should carry out activities in relation to sending participants, as well to preparing participants before and guiding them during and after the solidarity activity, including training participants and guiding them to local organisations after the solidarity activity in order to increase opportunities for further solidarity experiences. The quality label should reflect the fact that specific requirements vary depending on the type of solidarity activity provided, and certify that the organisation is able to ensure the quality of solidarity activities during all stages of the solidarity experience, in accordance with the principles and objectives of the Programme. Any entity which substantially changes its activities should inform the competent Programme implementing body, which can reassess whether that entity continues to comply with the conditions that led to the attribution of the quality label. (34) In order to support solidarity activities among young people, participating organisations could be public or private entities or international organisations, non-profit or profit-making, and could include youth organisations, religious institutions, charity associations, secular humanistic organisations, non-governmental organisations or other actors from civil society. (35) The scaling-up of Programme projects should be facilitated. Specific measures should be put in place to help promoters of Programme projects to apply for grants or develop synergies through the support of the European Structural and Investment Funds and the Union programmes relating to migration, security, justice and citizenship, health and culture. (36) European Solidarity Corps Resource Centres should assist the Programme implementing bodies, the participating organisations and the participants in order to raise the quality of the implementation of the Programme activities and to enhance the identification and validation of competences acquired through those activities, including through Youthpass. (37) The European Solidarity Corps Portal should be continuously developed in order to ensure easy access to the Programme in accordance with the standards established by Directive (EU) 2016/2102 of the European Parliament and of the Council (11) and to provide a one-stop shop for both interested individuals and organisations as regards, inter alia, the registration, identification and matching of profiles and opportunities, networking and virtual exchanges, online training, language and post-activity support and other useful functions which might arise in the future. (38) The European Solidarity Corps Portal should be further developed taking into account the European Interoperability Framework, set out in the communication of the Commission of 23 March 2017 entitled \u2018European Interoperability Framework \u2013 Implementation Strategy\u2019, which provides specific guidance on how to set up interoperable digital public services and is implemented in the Member States and other members of the European Economic Area through national interoperability frameworks. The European Interoperability Framework offers public administrations 47 concrete recommendations on how to improve the governance of their interoperability activities, to establish cross-organisational relationships, to streamline processes supporting end-to-end digital services and to ensure that neither existing nor new legal acts compromise interoperability efforts. (39) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (12) (the \u2018Financial Regulation\u2019) applies to the Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (40) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (13) and Council Regulations (EC, Euratom) No 2988/95 (14), (Euratom, EC) No 2185/96 (15) and (EU) 2017/1939 (16), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (17). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (41) The Programme is targeted at young people aged between 18 and 30. In order to participate in the activities offered by the Programme, such young people should be required to first register in the European Solidarity Corps Portal. (42) In view of the specific challenges of the humanitarian action, participants volunteering in support of humanitarian aid operations should be at least 18 years of age and not older than 35 years of age. (43) Particular attention should be paid to ensuring that solidarity activities are accessible to all young people, and in particular young people with fewer opportunities. Special measures should be put in place to promote social inclusion and, in particular, the participation of disadvantaged young people, including the provision of reasonable accommodation to enable people with disabilities to effectively participate in solidarity activities on an equal basis with others in accordance with Article 27 of the UN Convention on the Rights of Persons with Disabilities and with Council Directive 2000/78/EC (18). Such special measures should take into account the constraints imposed by the remoteness of a number of rural areas, of the outermost regions of the Union and of the overseas countries and territories and by the poverty of some peri-urban areas. Similarly, Member States, overseas countries and territories and third countries associated to the Programme should endeavour to adopt all appropriate measures to remove legal and administrative obstacles to the proper functioning of the Programme. Those measures should resolve, where possible and without prejudice to the Schengen acquis and Union law on the entry and residence of third-country nationals, administrative issues that create difficulties in obtaining visas and residence permits and, in the case of cross-border activities within the Union, obtaining a European Health Insurance Card. (44) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement adopted under the United Nations Framework Convention on Climate Change and to achieve the UN Sustainable Development Goals, the Programme is intended to contribute to mainstreaming climate actions in and to the achievement of an overall target of 30 % of the Union budget expenditure supporting climate objectives. In line with the European Green Deal as a blueprint for sustainable growth, the actions under this Regulation should respect the \u2018do no harm\u2019 principle without changing the fundamental character of the Programme. During the implementation of the Programme, relevant actions should be identified and put in place and reassessed in the context of the relevant evaluations and review process. It is also appropriate to measure relevant actions that contribute to climate objectives, including those intended to reduce the environmental impact of the Programme. (45) This Regulation lays down a financial envelope for the Programme which is to constitute the prime reference amount, within the meaning of Point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (19), for the European Parliament and the Council during the annual budgetary procedure. (46) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. When making that choice in relation to grants, the use of lump sums, flat rates and scales of unit costs should be considered. (47) Third countries which are members of the European Economic Area may participate in Union Programmes in the framework of the cooperation established under the Agreement on the European Economic Area (20), which provides for the implementation of those programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. The full participation of third countries in the Programme should be subject to the conditions laid down in specific agreements covering the participation of the third country concerned in the Programme. Full participation entails, moreover, the obligation to set up a national agency and the management of some of the Programme actions under indirect management. Legal entities from third countries that are not associated to the Programme should be able to participate in some of the Programme actions, as defined in the work programmes and the calls for proposals published by the Commission. When implementing the Programme, specific arrangements could be taken into account with regard to the participation of legal entities from Andorra, Liechtenstein, Monaco, San Marino and the Holy See. (48) In order to maximise the impact of the Programme, provisions should be made to allow Member States and third countries associated to the Programme and other Union programmes to make additional funding available in accordance with the rules of the Programme. (49) Pursuant to Council Decision 2013/755/EU (21), persons and entities established in overseas countries and territories are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (50) In view of Article 349 of the Treaty on the Functioning of the European Union (TFEU) and in line with the communication of the Commission of 24 October 2017 entitled \u2018A stronger and renewed strategic partnership with the EU\u2019s outermost regions\u2019, the Programme should take into account the specific situation of the outermost regions referred to in that Article. Measures should be taken to increase the participation of the outermost regions in all actions, including by means of financial support, where relevant, for mobility actions. Mobility exchanges and cooperation between people and organisations from those regions and third countries, in particular their neighbours, should be fostered. Such measures should be monitored and evaluated regularly. (51) In accordance with the Financial Regulation, the Commission should adopt work programmes and inform the European Parliament and the Council thereof. Work programmes should set out the measures needed for their implementation in line with the general and specific objectives of the Programme, the selection and award criteria for grants, as well as all other elements required. Work programmes and any amendments thereto should be adopted by means of implementing acts in accordance with the examination procedure. (52) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (22), the Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Programme on the ground, including effects on societal and humanitarian challenges. (53) Appropriate outreach, publicity and dissemination of the opportunities and results of the actions supported by the Programme should be ensured at local, national and European level. Particular attention should be paid to social enterprises, encouraging them to support the Programme activities. The outreach, publicity and dissemination activities should rely on all the Programme implementing bodies and should, where relevant, have the support of other key stakeholders. Furthermore, the Commission should engage with a broad range of stakeholders, including participating organisations, on a regular basis across the life cycle of the Programme, in order to facilitate the sharing of good practices and project results and gather feedback on the Programme. The national agencies should be invited to participate in that process. (54) In order to better achieve the objectives of the Programme, the Commission, national authorities and national agencies should preferably work closely together and, where appropriate, in partnership with non-governmental organisations, social enterprises, youth organisations, organisations representing people with disabilities, and local stakeholders that have expertise in solidarity actions. (55) In order to ensure greater efficiency in communication to the public at large and stronger synergies between the communication activities undertaken at the initiative of the Commission, the financial resources allocated to communication under this Regulation should also contribute to covering the corporate communication of the political priorities of the Union, insofar as those priorities are related to the general objective of the Programme. (56) In order to ensure that this Regulation is efficiently and effectively implemented, the Programme should make maximum use of management arrangements already in place. The overall implementation of the Programme should therefore be entrusted to existing structures, namely the Commission and the national agencies designated for the management of the actions referred to in the chapter on youth in Regulation (EU) 2021/817. Actions under the \u2018participation of young people in humanitarian aid related solidarity activities\u2019 strand, however, should be primarily managed directly. The Commission should regularly consult key stakeholders, including participating organisations, on the implementation of the Programme. (57) In order to ensure sound financial management and legal certainty in Member States and third countries associated to the Programme, each national authority should designate an independent audit body. Where feasible, and in order to maximise efficiency, the independent audit bodies should be the same as those designated for the actions referred to in chapter on youth in Regulation (EU) 2021/817. (58) Member States should endeavour to adopt all appropriate measures to remove legal and administrative obstacles to the proper functioning of the Programme. That includes resolving, where possible and without prejudice to Union law on the entry and residence of third-country nationals, issues that create difficulties in obtaining visas and residence permits. (59) The performance reporting system should ensure that data for monitoring Programme implementation and evaluation are collected efficiently, effectively, in a timely manner, and at the appropriate level of detail. Such data should be communicated to the Commission in a way that complies with relevant data protection rules. (60) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (23). (61) In order to simplify requirements for beneficiaries, simplified grants in the form of lump sums, flat-rate financing and unit costs should be used to the maximum possible extent. The simplified grants to support the mobility actions under the Programme, as defined by the Commission, should take into account the living and subsistence costs in the host country. In accordance with national law, Member States should also be encouraged to exempt those grants from any taxes and social levies; grants awarded to individuals by public or private legal entities should be treated in the same manner. (62) In order to ensure the effective assessment of the Programme\u2019s progress towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annex with regard to the Programme\u2019s performance indicators. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (63) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019). In particular, this Regulation seeks to ensure full respect for the right to equality between men and women and the right to non-discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, socioeconomic background, and to promote the application of Articles 21 and 23 of the Charter. (64) Horizontal financial rules adopted by the European Parliament and by the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (65) Since the objective of this Regulation, namely to enhance the engagement of young people and organisations in accessible and high-quality solidarity activities, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (66) In accordance with the Financial Regulation, it is possible to award a grant for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible for Union financing, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to the Union\u2019s interests, it should be possible to provide in the financing decision, for a limited period of time at the beginning of the 2021-2027 MFF, and only in duly justified cases, for eligibility of activities and costs from 1 January 2021, even if those activities were implemented and those costs incurred before the grant application was submitted. (67) Actions or initiatives that are not supported under this Regulation cannot be included in the work programmes. (68) In order to optimise the added value from investments funded wholly or in part through the budget of the Union, synergies should be sought in particular between the Programme and other Union programmes, including Funds implemented under shared management. To maximise those synergies, key enabling mechanisms should be ensured, including cumulative funding in an action from the Programme and another Union programme, as long as such cumulative funding does not exceed the total eligible costs of the action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility to declare the same cost or expenditure on a pro-rata basis to the Programme and another Union programme. (69) Regulation (EU) 2018/1475 of the European Parliament and of the Council (24) should be repealed with effect from 1 January 2021. (70) In order to ensure continuity in providing support in the relevant policy area and to allow implementation of the Programme to start from the beginning of the 2021-2027 MFF, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject matter 1. This Regulation establishes the European Solidarity Corps Programme (the \u2018Programme\u2019) for the period of the 2021-2027 MFF. 2. The Programme sets up the following two strands of actions: (a) the \u2018participation of young people in solidarity activities\u2019 strand; and (b) the \u2018participation of young people in humanitarian aid related solidarity activities\u2019 strand (the \u2018European Voluntary Humanitarian Aid Corps\u2019). 3. This Regulation lays down the objectives of the Programme, the budget for the period from 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018solidarity activity\u2019 means a high-quality, inclusive activity that addresses important societal challenges, that contributes to the achievement of the Programme objectives, that takes the form of volunteering, a solidarity project or a networking activity in various fields, including in the field of humanitarian aid, that ensures European added value and that complies with occupational health and safety regulations and relevant security rules; (2) \u2018registered candidate\u2019 means an individual aged between 17 and 30 years or, in the case of volunteering under the European Voluntary Humanitarian Aid Corps, between 17 and 35 years who is legally residing in a Member State, in a third country associated to the Programme or in another participating country under this Regulation and who has registered in the European Solidarity Corps Portal to express his or her interest in engaging in a solidarity activity but who is not yet participating in such an activity; (3) \u2018participant\u2019 means an individual aged between 18 and 30 years or, in the case of volunteering under the European Voluntary Humanitarian Aid Corps, between 18 and 35 years who is legally residing in a Member State, in a third country associated to the Programme or in another participating country under this Regulation, who has registered in the European Solidarity Corps Portal and who takes part in a solidarity activity; (4) \u2018young people with fewer opportunities\u2019 means young people who, for economic, social, cultural, geographical or health reasons, due to their migrant background, or for reasons such as a disability or educational difficulties or for any other reason, including a reason that could give rise to discrimination under Article 21 of the Charter, face obstacles that prevent them from having effective access to opportunities under the Programme; (5) \u2018participating organisation\u2019 means a local, regional, national or international public or private entity, whether non-profit or profit-making, that has been attributed a quality label; (6) \u2018volunteering\u2019 means a solidarity activity that takes place, for a period of up to 12 months, as a voluntary unpaid activity that contributes to the achievement of the common good; (7) \u2018solidarity project\u2019 means an unpaid solidarity activity that takes place for a period of up to 12 months and that is carried out by groups of at least five participants with a view to addressing key challenges within their communities while presenting a clear European added value; (8) \u2018quality label\u2019 means the certification attributed, on the basis of varying specific requirements depending on the type of solidarity activity provided, to a participating organisation willing to provide solidarity activities under the Programme in a host capacity, in a support capacity, or in both capacities; (9) \u2018European Solidarity Corps Resource Centres\u2019 means the additional functions performed by designated national agencies to support the development, implementation and quality of solidarity activities under the Programme as well as the identification of the competences acquired by the participants through their solidarity activities; (10) \u2018European Solidarity Corps Portal\u2019 means an interactive web-based tool, in all official languages of the Union, managed under the responsibility of the Commission, that provides relevant online services to support the quality implementation of the Programme, that complements the activities of participating organisations, including providing information about the Programme, that registers participants, that searches for participants, that advertises and searches for solidarity activities, that searches for potential project partners, that supports contact making and offers for solidarity activities, training and communication and networking activities, that informs and notifies users about opportunities, that provides a feedback mechanism regarding the quality of solidarity activities and that allows other functions to be added in response to relevant developments related to the Programme; (11) \u2018Union transparency and recognition tool\u2019 means an instrument that helps stakeholders to understand, appreciate and, as appropriate, recognise non-formal and informal learning outcomes throughout the Union; (12) \u2018humanitarian aid activity\u2019 means an activity that supports post-crisis and long-term humanitarian aid operations in third countries, that is intended to provide needs-based assistance aimed at preserving life, preventing and alleviating human suffering, and maintaining human dignity in the face of man-made crises or natural disasters, and that includes assistance, relief and protection operations in ongoing humanitarian crises or their aftermath, supporting measures to ensure access to people in need and to facilitate the free flow of assistance, and actions that aim to reinforce disaster preparedness and disaster risk reduction, link relief, rehabilitation and development and contribute towards strengthening the resilience and capacity of vulnerable or disaster-affected communities to cope with and recover from crises; (13) \u2018third country\u2019 means a country that is not member of the Union. Article 3 Programme objectives 1. The general objective of the Programme is to enhance the engagement of young people and organisations in accessible and high-quality solidarity activities, primarily volunteering, as a means to strengthen cohesion, solidarity, democracy, European identity and active citizenship in the Union and beyond, addressing societal and humanitarian challenges on the ground, with a particular focus on the promotion of sustainable development, social inclusion and equal opportunities. 2. The specific objective of the Programme is to provide young people, including young people with fewer opportunities, with easily accessible opportunities for engagement in solidarity activities that induce positive societal changes in the Union and beyond, while improving and properly validating their competences, as well as facilitating their continuous engagement as active citizens. 3. The Programme objectives shall be implemented under the strands of actions set out in Article 1(2). CHAPTER II Programme actions Article 4 Programme actions 1. The Programme shall support the following actions: (a) volunteering as set out in Articles 7 and 10; (b) solidarity projects as set out in Article 8; (c) networking activities as set out in Article 5(1); and (d) quality and support measures as set out in Article 5(2). 2. The Programme shall support solidarity activities which present a clear European added value, for example through their: (a) transnational character, particularly with regard to learning mobility and cooperation; (b) ability to complement other programmes and policies at local, regional, national, Union and international level; (c) European dimension regarding their themes and aims, approaches, expected outcomes and other aspects of those solidarity activities; (d) approach to involving young people from different backgrounds; (e) contribution to the effective use of Union transparency and recognition tools. 3. Solidarity activities shall be implemented in accordance with specific requirements set for each type of activity carried out in the framework of the Programme as referred to in Articles 5, 7, 8 and 10, as well as with applicable regulatory frameworks in Member States and third countries associated to the Programme. 4. References to the European Voluntary Service in the legal acts of the Union shall be read as including references to volunteering under both Regulation (EU) No 1288/2013 and this Regulation. Article 5 Actions common to both strands 1. Networking activities shall be carried out in-country or cross-border and shall aim to: (a) reinforce the capacities of participating organisations to offer high-quality, easily accessible projects to an increasing number of participants; (b) attract new participants and new participating organisations; (c) provide participants and participating organisations with opportunities to give feedback on solidarity activities and to promote the Programme; and (d) contribute to the exchange of experiences and strengthening of a sense of belonging among participants and participating organisations, thereby supporting the wider positive impact of the Programme, including through activities such as the exchange of best practices and the creation of networks. 2. Quality and support measures shall include: (a) appropriate measures to provide clearance requirements in accordance with applicable national law; (b) measures taken before, during or after the solidarity activities that aim to ensure the quality and accessibility of those activities, including online and offline training, adapted, where appropriate, to the solidarity activity in question and its context, language support, insurance, including accident and sickness insurance, the further use of Youthpass, which identifies and documents the competences acquired by participants during the solidarity activities, capacity building, and administrative support for participating organisations; (c) the development and maintenance of a quality label; (d) the activities of European Solidarity Corps Resource Centres to support and raise the quality of the implementation of the Programme actions and enhance the validation of their outcomes; and (e) the establishment, maintenance and updating of an accessible European Solidarity Corps Portal and of other relevant online services, as well as necessary IT support systems and web-based tools. CHAPTER III Participation of young people in solidarity activities Article 6 Purpose and types of actions 1. Actions implemented under the \u2018participation of young people in solidarity activities\u2019 strand shall, in particular, contribute to strengthening cohesion, solidarity, active citizenship and democracy within and outside the Union, while also responding to societal challenges with a particular focus on the promotion of social inclusion and equal opportunities. 2. The \u2018participation of young people in solidarity activities\u2019 strand shall support the following actions: (a) volunteering as set out in Article 7; (b) solidarity projects as set out in Article 8; (c) networking activities for individuals and organisations participating in this strand as set out in Article 5(1); (d) quality and support measures as set out in Article 5(2). Article 7 Volunteering under the \u2018participation of young people in solidarity activities\u2019 strand 1. Volunteering shall: (a) include a learning and training component; (b) not be a substitute for traineeships or jobs; (c) not be equated with employment; and (d) be based on a written volunteering agreement. The agreement referred to in point (d) of the first subparagraph shall set out the rights and obligations of the parties to that agreement, the duration and location of deployment and a description of the tasks involved. Such an agreement shall refer to the terms of the participants\u2019 insurance coverage and, where appropriate, to the relevant clearance requirements, in accordance with applicable national law. 2. Volunteering may take place in a country other than the participant\u2019s country of residence (\u2018cross-border volunteering\u2019) or in the participant\u2019s country of residence (\u2018in-country volunteering\u2019). In-country volunteering shall be open to the participation of all young people, in particular young people with fewer opportunities. Article 8 Solidarity projects Solidarity projects shall not be a substitute for traineeships or jobs. CHAPTER IV European Voluntary Humanitarian Aid Corps Article 9 Purpose, principles and types of actions 1. Actions under the European Voluntary Humanitarian Aid Corps shall, in particular, contribute to providing needs-based humanitarian aid aimed at preserving life, preventing and alleviating human suffering and maintaining human dignity and to strengthening the capacity and resilience of vulnerable or disaster-affected communities. 2. The actions under the European Voluntary Humanitarian Aid Corps shall: (a) be carried out in compliance with the humanitarian principles of humanity, neutrality, impartiality and independence, as well as with the \u2018do no harm\u2019 principle; (b) respond to the humanitarian needs of local communities identified in cooperation with humanitarian and other relevant partners within the hosting country or region; (c) be planned on the basis of risk assessments and undertaken in a way that ensures that there is a high level of safety and security for volunteers; (d) where relevant, facilitate the transition from the humanitarian response to long-term sustainable and inclusive development; (e) facilitate the active involvement of local staff and volunteers from the countries and communities in which they are implemented; (f) wherever relevant, take into account the specific needs of women and seek to involve women and groups and networks of women; and (g) contribute to efforts to strengthen local preparedness or the response to humanitarian crises. 3. The European Voluntary Humanitarian Aid Corps shall support the following actions: (a) volunteering as set out in Article 10; (b) networking activities for individuals and organisations participating in the European Voluntary Humanitarian Aid Corps as set out in Article 5(1); (c) quality and support measures as set out in Article 5(2), with a particular focus on measures to ensure the safety and security of participants. Article 10 Volunteering under the European Voluntary Humanitarian Aid Corps 1. Volunteering under the European Voluntary Humanitarian Aid Corps shall: (a) include a learning and training component, including on the principles set out in Article 10(2), and, where appropriate, development and capacity building components, with the involvement of highly skilled, highly trained and experienced coaches, mentors and experts; (b) not be a substitute for traineeships or jobs; (c) not be equated with employment; and (d) be based on a written volunteering agreement. The agreement referred to in point (d) of the first subparagraph shall set out the rights and obligations of the parties to that agreement, the duration and location of deployment and a description of the tasks involved. Such an agreement shall refer to the terms of the participants\u2019 insurance coverage and, where appropriate, to the relevant clearance requirements, in accordance with applicable national law. 2. Volunteering under the European Voluntary Humanitarian Aid Corps may only take place in those regions of third countries in which: (a) humanitarian aid activities and operations take place; and (b) there are no ongoing international or non-international armed conflicts. CHAPTER V Financial provisions Article 11 Budget 1. The financial envelope for the implementation of the Programme for the period from 2021 to 2027 shall be EUR 1 009 000 000 in current prices. 2. With a maximum of 20 % for in-country volunteering, the indicative distribution of the amount set out in paragraph 1 for the actions referred to in points (a), (b) and (c) of Article 4(1) shall be: (a) 94 % for volunteering as set out in Article 7 and solidarity projects; (b) 6 % for volunteering as set out in Article 10. 3. The amount set out in paragraph 1 may be used for technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities, including corporate information technology systems. 4. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme, subject to the conditions set out in Article 26 of a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the \u2018Common Provisions Regulation for 2021-2027\u2019). The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. Article 12 Forms of Union funding and methods of implementation 1. The Programme shall be implemented, in a consistent manner, under direct management in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or under indirect management with bodies as referred to in point (c) of the first subparagraph of Article 62(1) of that Regulation. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular grants, prizes and procurement. 3. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and shall be considered a sufficient guarantee under the Financial Regulation. Article 37(7) of Regulation (EU) 2021/695 of the European Parliament and of the Council (25) shall apply. 4. For selections under both direct and indirect management, members of the evaluation committee may be external experts as provided for in the third subparagraph of Article 150(3) of the Financial Regulation. CHAPTER VI Participation in the programme Article 13 Third countries associated to the Programme 1. The Programme shall be open to the participation of the following third countries: (a) members of the European Free Trade Association which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidate countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes and their administrative costs; (iii) does not confer on the third country any decision-making power in respect of the Union programme; and (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. The contributions referred to in point (d)(ii) of the first subparagraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. 2. The countries listed in paragraph 1 may only participate in the Programme in its entirety and provided that they fulfil all the obligations which this Regulation imposes on Member States. Article 14 Other participating countries 1. The Programme shall be open to the participation of overseas countries and territories. 2. In duly justified cases in the Union\u2019s interest, the actions referred to in Article 5 and volunteering as referred to in Article 7 may also be open to participation of legal entities of third countries not associated to the Programme. Article 15 Participation of individuals 1. Young people aged between 17 and 30 years or, in the case of volunteering under the European Voluntary Humanitarian Aid Corps as set out in Article 10, between 17 and 35 years who wish to participate in the Programme shall register in the European Solidarity Corps Portal. 2. At the moment of commencing volunteering or a solidarity project under the \u2018participation of young people in solidarity activities\u2019 strand, a participant shall be at least 18 years of age and not older than 30 years of age. At the moment of commencing volunteering under the European Voluntary Humanitarian Aid Corps as set out in Article 10, a participant shall be at least 18 years of age and not older than 35 years of age. Article 16 Inclusion of young people with fewer opportunities 1. When implementing this Regulation, the Commission, the Member States and third countries associated to the Programme shall ensure that specific and effective measures are taken to promote social inclusion and equal access conditions, in particular for the participation of young people with fewer opportunities. 2. The Commission shall, by 9 December 2021, develop a framework of inclusion measures to increase participation rates among people with fewer opportunities and guidance for the implementation of such measures. That guidance shall be updated as necessary over the duration of the Programme. Based on the framework of inclusion measures, and with particular attention to the specific Programme access challenges within the national contexts, inclusion action plans shall be developed and shall form an integral part of the national agencies\u2019 work programmes. The Commission shall monitor the implementation of those inclusion action plans on a regular basis. 3. The Commission shall, where relevant, and safeguarding sound financial management, ensure that financial support measures, including pre-financing, are put in place to facilitate the participation of young people with fewer opportunities in the Programme. The level of support shall be based on objective criteria. Article 17 Participating organisations 1. The Programme shall be open to the participation of public or private entities, whether non-profit or profit-making, and international organisations, provided that they have received a quality label. 2. The competent Programme implementing body shall assess an application from an entity to become a participating organisation based on the principles of: (a) equal treatment; (b) equal opportunities and non-discrimination; (c) the avoidance of job substitution; (d) the avoidance of harmful activities; (e) the provision of high quality, easily accessible and inclusive activities with a learning dimension focusing on personal, socio-educational and professional development; (f) adequate volunteering arrangements; (g) safe and decent environments and conditions, with internal mechanisms for conflict resolution to protect the participant; and (h) \u2018no-profit\u2019 in accordance with the Financial Regulation. The competent Programme implementing body shall use the principles referred to in the first subparagraph to ascertain whether the activities of the entity applying to become a participating organisation meet the requirements and objectives of the Programme. 3. As a result of the assessment referred to in paragraph 2, the entity may be attributed a quality label. The competent Programme implementing body shall periodically reassess whether the entity continues to comply with the conditions that led to the attribution of the quality label. Where the entity no longer complies with those conditions, the competent Programme implementing body shall take remedial measures until such time as the conditions and quality requirements are met. In the event of continued failure to comply with those conditions and quality requirements, the quality label shall be revoked. 4. Any entity which has received a quality label shall be given access to the European Solidarity Corps Portal in a host capacity, in a support capacity, or in both capacities, and shall be able to make offers of solidarity activities to registered candidates. 5. The quality label shall not automatically lead to funding under the Programme. 6. The solidarity activities and related quality and support measures offered by a participating organisation may receive funding under the Programme or from other funding sources which do not depend on the Union budget. 7. For participating organisations under the European Voluntary Humanitarian Aid Corps, the safety and security of volunteers, based on risk assessments, shall be a priority. 8. After completion of the solidarity activity and if requested by the participant, a participating organisation shall provide the participant with a certification stating the learning outcomes of, and skills developed during, the solidarity activity, such as Youthpass or Europass. Article 18 Access to the funding under the Programme Any public or private entity established in a Member State, overseas country or territory or third country associated to the Programme, as well as any international organisation, may apply for funding under the Programme. In the case of volunteering as set out in Articles 7 and 10, the participating organisation shall, as a pre-condition, have obtained a quality label in order to receive funding under the Programme. In the case of the solidarity projects referred to in Article 8, natural persons may also apply for funding on behalf of informal groups of participants. As a general rule, the grant application shall be submitted to the national agency of the country in which the entity, organisation or natural person is based. CHAPTER VII Programming, monitoring and evaluation Article 19 Work programme The Programme shall be implemented by work programmes as referred to in Article 110 of the Financial Regulation. Work programmes shall give an indication of the amount allocated to each action and of the distribution of funds between the Member States and third countries associated to the Programme for the actions to be managed through the national agency. The Commission shall adopt work programmes by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31. Article 20 Monitoring and reporting 1. Indicators to report on the progress of the Programme towards the achievement of the general and specific objectives laid down in Article 3 are set out in the Annex. 2. To ensure the effective assessment of the Programme\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 30, to amend the Annex with regard to the indicators, where considered necessary, and to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 3. The performance reporting system shall ensure that data for monitoring the implementation and results of the Programme are collected efficiently, effectively, in a timely manner and at the appropriate level of detail. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where appropriate, on Member States. Article 21 Evaluation 1. The Commission shall carry out evaluations in a timely manner to feed into the decision-making process. 2. Once sufficient information about the implementation of the Programme is available but, in any event, no later than 31 December 2024, the Commission shall carry out an interim evaluation of the Programme. That interim evaluation shall also be accompanied by a final evaluation of the 2018-2020 European Solidarity Corps Programme, which shall feed into the interim evaluation. The interim evaluation of the Programme shall assess the overall effectiveness and performance of the Programme, as well as the delivery of the inclusion measures. 3. Without prejudice to the requirements set out in Chapter IX and the obligations of national agencies set out in Article 24, Member States shall submit to the Commission, by 31 May 2024, a report on the implementation and the impact of the Programme in their respective territories. 4. Where appropriate, and on the basis of the interim evaluation, the Commission shall put forward a legislative proposal to amend this Regulation. 5. After 31 December 2027 but, in any event, no later than 31 December 2031, the Commission shall carry out a final evaluation of the results and impact of the Programme. 6. The Commission shall transmit any evaluations carried out under this Article, including the interim evaluation, accompanied by its observations, to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions. CHAPTER VIII Information, communication and dissemination Article 22 Information, communication and dissemination 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the Programme, to actions taken pursuant to the Programme and to the results obtained. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. 3. In cooperation with the Commission, the national agencies shall develop a consistent strategy with regard to effective outreach, and the dissemination and exploitation of the results of activities supported under the actions they manage within the Programme. The national agencies shall assist the Commission in its general task of disseminating information concerning the Programme, including information in respect of actions and activities managed at national and Union level, and its results. National agencies shall inform relevant target groups about the actions and activities undertaken in their respective countries. 4. Participating organisations shall use the name \u2018European Solidarity Corps\u2019 for the purposes of communicating and disseminating information related to the Programme. CHAPTER IX Management and audit system Article 23 National authority In each Member State and third country associated to the Programme, the national authorities designated for the management of actions referred to in Chapter III of Regulation (EU) 2021/817 shall also act as national authorities in the framework of the Programme. Article 26(1), (2), (6), (7), (9), (10), (11), (12), (13) and (14) of Regulation (EU) 2021/817 shall apply mutatis mutandis to national authorities under the Programme. Article 24 National agency 1. In each Member State and third country associated to the Programme, the national agencies designated for the management of the actions referred to in Chapter III of Regulation (EU) 2021/817 in their respective countries shall also act as national agencies in the framework of the Programme. Article 27(1) and (2) and (4) to (8) of Regulation (EU) 2021/817 shall apply mutatis mutandis to the national agencies under the Programme. 2. Without prejudice to Article 27(2) of Regulation (EU) 2021/817, the national agency shall also be responsible for managing all stages of the project lifecycle of those Programme actions listed in the implementing acts referred to in Article 19 of this Regulation, in accordance with point (c) of the first subparagraph of Article 62(1) of the Financial Regulation. 3. Where a national agency has not been designated for a third country as referred to in Article 13(1) of this Regulation, it shall be established in accordance with Article 27 of Regulation (EU) 2021/817. Article 25 European Commission 1. The rules applying to the relationship between the Commission and a national agency shall be laid down, in accordance with Article 27 of Regulation (EU) 2021/817, in a written document which shall: (a) set out the internal control standards for the national agency concerned and the rules for the management of the Union funds for grant support by the national agencies; (b) include the national agency work programme comprising the management tasks of the national agency to which Union support is provided; and (c) specify the reporting requirements for the national agency. 2. Each year, the Commission shall make the following funds available to the national agency: (a) funds for grant support in the Member State or third country associated to the Programme concerned for Programme actions the management of which is entrusted to the national agency; (b) a financial contribution in support of the national agency\u2019s management tasks, which shall be established in accordance with the arrangements set out in point (b) of Article 28(3) of Regulation (EU) 2021/817. 3. The Commission shall lay down the requirements for the national agency\u2019s work programme. The Commission shall not make Programme funds available to the national agency before having formally approved the national agency\u2019s work programme. 4. On the basis of the compliance requirements for national agencies referred to in Article 26(3) of Regulation (EU) 2021/817, the Commission shall review the national management and control systems, the national agency\u2019s yearly management declaration and the opinion of the independent audit body thereon, taking due account of the information provided by the national authority on its monitoring and supervision activities with regard to the Programme. 5. After assessing the yearly management declaration and the opinion of the independent audit body thereon, the Commission shall address its opinion and observations to the national agency and the national authority. 6. In the event that the Commission cannot accept the yearly management declaration or the independent audit opinion thereon, or in the event of unsatisfactory implementation by the national agency of the Commission\u2019s observations, the Commission may implement any precautionary and corrective measures necessary to safeguard the Union\u2019s financial interests in accordance with point (c) of the first subparagraph of Article 131(3) of the Financial Regulation. Article 26 Independent audit body 1. The independent audit body shall issue an audit opinion on the yearly management declaration as referred to in point (c) of Article 155(1) of the Financial Regulation. It shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. 2. The independent audit body shall: (a) have the necessary professional competence to carry out public sector audits; (b) ensure that its audits take account of internationally accepted audit standards; and (c) not be in a position of conflict of interest with regard to the legal entity of which the national agency forms part and shall be independent, in terms of its functions, of the legal entity of which the national agency forms part. 3. The independent audit body shall give the Commission and its representatives and the Court of Auditors full access to all documents and reports in support of the audit opinion that it issues on the national agency\u2019s yearly management declaration. CHAPTER X Control system Article 27 Principles of the control system 1. The Commission shall be responsible for the supervisory controls with regard to the Programme actions managed by the national agencies. It shall set the minimum requirements for the controls by the national agency and the independent audit body. 2. National agencies shall be responsible for the primary controls of grant beneficiaries for the Programme actions which are entrusted to them. Those controls shall provide reasonable assurance that the grants awarded are used as intended and in compliance with the applicable Union rules. 3. With regard to the Programme funds transferred to the national agencies, the Commission shall ensure proper coordination of its controls with the national authorities and the national agencies on the basis of the single audit principle and following a risk-based analysis. This paragraph shall not apply to investigations carried out by OLAF. Article 28 Protection of the financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. CHAPTER XI Complementarity Article 29 Complementarity of Union action 1. The Programme actions shall be consistent with and complementary to the relevant policies, instruments and programmes at Union level, in particular the Erasmus+ Programme, as well as to existing networks at Union level relevant to the activities of the Programme. 2. The Programme actions shall also be consistent with and complementary to the relevant policies, programmes and instruments at national level in the Member States and third countries associated to the Programme. To that end, the Commission, national authorities and national agencies shall exchange information on existing national schemes and priorities related to solidarity and youth, on the one hand, and actions under the Programme, on the other hand, with a view to building on relevant good practices and achieving efficiency and effectiveness. 3. Volunteering as set out in Article 10 shall, in particular, be consistent with and complementary to other areas of Union external action, in particular humanitarian aid policy, development cooperation policy, enlargement policy, neighbourhood policy and the Union Civil Protection Mechanism. 4. An action that has received a contribution under the Programme may also receive a contribution from another Union programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 5. Project proposals may receive support from the European Regional Development Fund or the European Social Fund Plus, in accordance with Article 73(4) of the Common Provisions Regulation for 2021-2027, where they have been awarded a Seal of Excellence label under the Programme by virtue of complying with the following cumulative conditions: (a) they have been assessed in a call for proposals under the Programme; (b) they comply with the minimum quality requirements of that call for proposals; and (c) they cannot be financed under that call for proposals due to budgetary constraints. CHAPTER XII Transitional and final provisions Article 30 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 20 shall be conferred on the Commission for the duration of the Programme. 3. The delegation of power referred to in Article 20 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 20 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 31 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 32 Repeal Regulations (EU) 2018/1475 and (EU) No 375/2014 are repealed with effect from 1 January 2021. Article 33 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulation (EU) 2018/1475 or (EU) No 375/2014, which shall continue to apply to those actions until their closure. 2. The financial envelope for the Programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted pursuant to Regulation (EU) 2018/1475 or (EU) No 375/2014. 3. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, and by way of derogation from Article 193(4) of that Regulation, in duly justified cases specified in the financing decision, activities supported under this Regulation and the underlying costs incurred in 2021 may be considered eligible as of 1 January 2021, even if those activities were implemented and those costs incurred before the grant application was submitted. 4. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 11(3) in order to enable the management of actions and activities not completed by 31 December 2027. 5. Member States shall ensure, at national level, the unimpeded transition between the actions implemented under the 2018-2020 European Solidarity Corps Programme and those to be implemented under the Programme. Article 34 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 May 2021. For the European Parliament The President D.M. SASSOLI For the Council The President A.P. ZACARIAS (1) OJ C 62, 15.2.2019, p. 201. (2) OJ C 86, 7.3.2019, p. 282. (3) Position of the European Parliament of 12 March 2019 (OJ C 23, 21.1.2021, p. 218) and position of the Council at first reading of 20 April 2021 (not yet published in the Official Journal). Position of the European Parliament of 18 May 2021 (not yet published in the Official Journal). (4) OJ C 25, 30.1.2008, p. 1. (5) OJ C 456, 18.12.2018, p. 1. (6) Regulation (EU) 2021/817 of the European Parliament and of the Council of 20 May 2021 establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 (OJ L 189, 28.5.2021, p. 1). (7) Regulation (EU) No 1288/2013 of the European Parliament and of the Council of 11 December 2013 establishing \u2018Erasmus+\u2019: the Union programme for education, training, youth and sport and repealing Decisions No 1719/2006/EC, No 1720/2006/EC and No 1298/2008/EC (OJ L 347, 20.12.2013, p. 50). (8) Regulation (EU) No 375/2014 of the European Parliament and of the Council of 3 April 2014 establishing the European Voluntary Humanitarian Aid Corps (\u2018EU Aid Volunteers initiative\u2019) (OJ L 122, 24.4.2014, p. 1). (9) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (10) Council Recommendation of 20 December 2012 on the validation of non-formal and informal learning (OJ C 398, 22.12.2012, p. 1). (11) Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1). (12) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (13) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (14) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (15) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (16) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (17) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (18) Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation (OJ L 303, 2.12.2000, p. 16). (19) OJ L 433 I, 22.12.2020, p. 28. (20) OJ L 1, 3.1.1994, p. 3. (21) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (\u2018Overseas Association Decision\u2019) (OJ L 344, 19.12.2013, p. 1). (22) OJ L 123, 12.5.2016, p. 1. (23) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (24) Regulation (EU) 2018/1475 of the European Parliament and of the Council of 2 October 2018 laying down the legal framework of the European Solidarity Corps and amending Regulation (EU) No 1288/2013, Regulation (EU) No 1293/2013 and Decision No 1313/2013/EU (OJ L 250, 4.10.2018, p. 1). (25) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). ANNEX The measurements of quantitative indicators shall be disaggregated, where appropriate, by country, professional background, level of educational attainment, gender and type of action and activity. The following areas are to be monitored: (a) the number of participants in solidarity activities; (b) the share of participants with fewer opportunities; (c) the number of organisations holding a quality label; (d) the number of participants who are young people with fewer opportunities; (e) the share of participants reporting positive learning outcomes; (f) the share of participants whose learning outcomes have been documented through a Union transparency and recognition tool such as Youthpass, Europass or a national tool; (g) the overall satisfaction rate of participants with regard to the quality of activities; (h) the share of activities that address climate objectives; (i) the degree of satisfaction of volunteers deployed in the humanitarian aid field and of participating organisations with regard to the effective humanitarian contribution of the activities on the ground; (j) the number of activities in third countries that contribute to strengthening local actors and local communities and complementing volunteering under the European Voluntary Humanitarian Aid Corps.", "summary": "European Solidarity Corps programme 2021-2027 European Solidarity Corps programme 2021-2027 SUMMARY OF: Regulation (EU) 2021/888 establishing the European Solidarity Corps programme WHAT IS THE AIM OF THE REGULATION? The European Solidarity Corps (ESC) programme aims to enhance the engagement of young people and organisations in accessible and high-quality solidarity activities, primarily volunteering, as a means to strengthen cohesion, solidarity, democracy, European identity and active citizenship in the European Union (EU) and beyond. KEY POINTS The ESC replaces the European Voluntary Service, the EU volunteering programme, with an increased focus on social issues. The programme is required to be consistent and complementary with other EU policies, in particular with the EU youth strategy and with Erasmus+ established by Regulation (EU) 2021/817 (see summary). Specific objective The ESC programme aims to provide young people, including those with fewer opportunities, with easily accessible opportunities for engagement in solidarity activities that induce positive societal changes in the EU and beyond, while also improving and properly validating their competences, and facilitating their continuous engagement as active citizens. Action strands The programme sets up two strands of action for the participation of young people: solidarity activities* \u2014 actions envisaged under this strand include volunteering, solidarity projects and networking opportunities; humanitarian aid activities, the European Voluntary Humanitarian Aid Corps \u2014 actions must contribute to providing needs-based humanitarian aid aimed at preserving life, preventing and alleviating human suffering and maintaining human dignity, while also strengthening the capacity and resilience of vulnerable or disaster-affected communities. The programme will be implemented through work programmes adopted by the European Commission by means of implementing acts. Participation The ESC offers voluntary activities to young people between 18 and 30 years of age. The upper age limit for volunteers in the field of humanitarian aid is 35, with the possibility of hiring experts and coaches without an upper age limit. Projects can last up to 12 months. The programme allows young people to volunteer for more than one project, provided that the total time on the programme is not more than 12 months. At the end of the experience, the young people will be given a \u2018Youthpass\u2019 explaining the activities carried out while volunteering, showing the skills acquired by the volunteers and reflecting their learning process. Budget The programme runs from 1 January 2021 to 31 December 2027, the duration of the multiannual financial framework. The financial envelope for the implementation of the programme for 2021-2027 is set at \u20ac1.009 billion in current prices. With a maximum of 20% allocated to national volunteering, the amount is broken down as follows: 94% for volunteering and solidarity projects;6% for volunteering under the European Voluntary Humanitarian Aid Corps. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND European Solidarity Corps guide (European Commission). KEY TERMS Solidarity activity: a high-quality, inclusive activity that addresses important societal challenges, that contributes to the achievement of the programme objectives, that takes the form of volunteering, a solidarity project or a networking activity in various fields, including in the field of humanitarian aid, that ensures European added value, and that complies with occupational health and safety regulations and follows the relevant security rules. MAIN DOCUMENT Regulation (EU) 2021/888 of the European Parliament and of the Council of 20 May 2021 establishing the European Solidarity Corps Programme and repealing Regulations (EU) 2018/1475 and (EU) No 375/2014 (OJ L 202, 8.6.2021, pp. 32-54) RELATED DOCUMENTS Regulation (EU) 2021/817 of the European Parliament and of the Council of 20 May 2021 establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 (OJ L 189, 28.5.2021, pp. 1-33) Resolution of the Council of the European Union and the Representatives of the Governments of the Member States meeting within the Council on a framework for European cooperation in the youth field: The European Union Youth Strategy 2019-2027 (OJ C 456, 18.12.2018, pp. 1-22) European Parliament legislative resolution P8_TA(2018)0328 European Solidarity Corps ***I of 11 September 2018 on the proposal for a regulation of the European Parliament and of the Council laying down the legal framework of the European Solidarity Corps and amending Regulations (EU) No 1288/2013, (EU) No 1293/2013, (EU) No 1303/2013, (EU) No 1305/2013, (EU) No 1306/2013 and Decision No 1313/2013/EU (COM(2017) 262 \u2014 C8-0162/2017 \u2014 2017/0102(COD)) P8_TC1-COD(2017)0102 \u2014 Position of the European Parliament adopted at first reading on 11 September 2018 with a view to the adoption of Regulation (EU) 2018/\u2026 of the European Parliament and of the Council laying down the legal framework of the European Solidarity Corps and amending Regulation (EU) No 1288/2013, Regulation (EU) No 1293/2013 and Decision No 1313/2013/EU (OJ C 433, 23.12.2019, pp. 222-224) last update 28.07.2021"}
{"article": "3.5.2021 EN Official Journal of the European Union L 153/48 REGULATION (EU) 2021/691 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 April 2021 on the European Globalisation Adjustment Fund for Displaced Workers (EGF) and repealing Regulation (EU) No 1309/2013 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the third paragraph of Article 175 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The horizontal principles set out in Article 3 of the Treaty on European Union (TEU) and in Articles 9 and 10 of the Treaty on the Functioning of the European Union (TFEU), including the principles of subsidiarity and proportionality set out in Article 5 TEU, are to be respected in the implementation of Union funds, taking into account the Charter of Fundamental Rights of the European Union. Pursuant to Articles 8 and 10 TFEU, the Union is to aim to eliminate inequalities and promote equality between men and women as well as to combat discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation. The Commission and Member States should aim to integrate the gender perspective in the implementation of the funds. The objectives of Union funds should be pursued in the framework of sustainable development and the Union\u2019s objectives of preserving, protecting and improving the quality of the environment as set out in Article 11 and Article 191(1) TFEU, taking into account the polluter-pays principle. (2) On 17 November 2017, the European Pillar of Social Rights (the \u2018Pillar\u2019) was jointly proclaimed by the European Parliament, the Council and the Commission as a response to social challenges in Europe. Taking into account the changing realities of the world of work, it is necessary for the Union to prepare for the current and future challenges of globalisation and digitisation, by making growth more inclusive and by improving employment and social policies. The 20 key principles of the Pillar are structured in three categories: equal opportunities and access to the labour market; fair working conditions; and social protection and inclusion. The Pillar acts as an overarching guiding framework for the European Globalisation Adjustment Fund for Displaced Workers (EGF) established by this Regulation, allowing the Union to put the relevant principles into practice in the case of major restructuring events. (3) On 20 June 2017, the Council endorsed the Union response to the United Nations (UN) 2030 Agenda for Sustainable Development. The Council underlined the importance of achieving sustainable development across the three dimensions \u2013 economic, social and environmental \u2013 in a balanced and integrated way. It is vital that sustainable development be mainstreamed in the Union policy framework and that the Union be ambitious in the policies that it uses to address global challenges. The Council welcomed the Commission communication of 22 November 2016 entitled \u2018Next steps for a sustainable European future\u2019 as a first step in mainstreaming the UN\u2019s Sustainable Development Goals and applying sustainable development as an essential guiding principle to all Union policies, including through its financing instruments. (4) In February 2018, the Commission adopted a communication entitled \u2018A new, modern Multiannual Financial Framework for a European Union that delivers efficiently on its priorities post-2020\u2019. The communication stresses that the Union budget supports Europe\u2019s unique social market economy. It is of the utmost importance to improve employment opportunities and to address skills challenges, especially those linked to digitisation, automation and a transition towards a resource-efficient and sustainable economy, in full compliance with the Paris Agreement, adopted under the UN\u2019s Framework Convention on Climate Change (the \u2018Paris Agreement\u2019). Budgetary flexibility will be a key principle in the multiannual financial framework 2021 to 2027 (MFF 2021 to 2027) established by Council Regulation (EU, Euratom) 2020/2093 (4). Flexibility mechanisms will remain in place to allow the Union to react in a more timely manner and to ensure that budgetary resources are used where most urgently needed. (5) In its \u2018White Paper on the Future of Europe\u2019 of 1 March 2017, the Commission expresses concerns regarding isolationist movements and growing doubts over the benefits of open trade and the Union\u2019s social market economy in general. (6) In its \u2018Reflection Paper on Harnessing Globalisation\u2019 of 10 May 2017, the Commission identifies the combination of trade-related globalisation and technological change as the major driver of increased demand for skilled labour and the reduction in the number of jobs that require lower qualifications. While acknowledging the advantages of more open trade, the Commission finds that appropriate means are needed to address related negative side effects. As the current benefits of globalisation are already unequally distributed among people and regions, causing a significant impact on those adversely affected, there is a danger that technological and environmental changes will further fuel those effects. Therefore, in line with the principles of solidarity and sustainability, it will be necessary to ensure that the benefits of globalisation are shared more fairly by reconciling economic growth and technological advance with adequate social protection and active support for access to employment and self-employment opportunities. (7) In its \u2018Reflection Paper on the Future of Union Finances\u2019 of 28 June 2017, the Commission underlines the need to reduce economic and social divergences between and within Member States and finds that, therefore, a key priority is to invest in sustainable development, equality, social inclusion, education and training as well as health. (8) Globalisation, technological change and climate change are likely to further increase the interconnectedness and interdependence of world economies. Labour reallocation is an integral and inevitable part of such change. If the benefits of change are to be distributed fairly, offering assistance to displaced workers and those threatened by displacement is of the utmost importance. The main Union instruments to assist affected workers are the European Social Fund Plus (ESF+), which is to be established by a Regulation of the European Parliament and of the Council and is designed to offer assistance in an anticipatory manner, and the EGF, which is designed to offer assistance in a reactive manner in the case of major restructuring events. The Commission\u2019s communication entitled \u2018EU Quality Framework for anticipation of change and restructuring\u2019 of 13 December 2013 is the Union policy instrument that sets the framework of best practice for anticipating and dealing with corporate restructuring. It offers a comprehensive framework on how the challenges of economic adjustment and restructuring and their employment and social impact are to be addressed by adequate policy means. It also calls upon Member States to use Union and national funding in a way that ensures that the social impact of restructuring, especially the adverse effects on employment, can be cushioned more effectively. (9) The European Globalisation Adjustment Fund, established by Regulation (EC) No 1927/2006 of the European Parliament and of the Council (5) for the MFF 2007 to 2013 (the \u2018Fund\u2019), was set up to enable the Union to show solidarity towards workers who had lost their jobs as a result of major structural changes in world trade patterns due to globalisation. (10) The scope of Regulation (EC) No 1927/2006 was broadened by Regulation (EC) No 546/2009 of the European Parliament and of the Council (6) as part of the European Economic Recovery Plan, set out in the Commission communication of 26 November 2008, in order to include workers who had lost their jobs as a direct consequence of the global financial and economic crisis. (11) For the duration of the MFF 2014 to 2020, Regulation (EU) No 1309/2013 of the European Parliament and of the Council (7) extended the scope of the Fund to cover job displacements resulting not only from a serious economic disruption caused by a continuation of the global financial and economic crisis addressed in Regulation (EC) No 546/2009, but also from any new global financial and economic crisis. Furthermore, Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (8) (the \u2018Financial Regulation\u2019) amended Regulation (EU) No 1309/2013 to introduce, inter alia, rules allowing the Fund, exceptionally, to cover collective applications involving small and medium-sized enterprises (SMEs) located in one region which operate in different economic sectors defined at NACE Revision 2 division level, where the applicant Member State demonstrates that SMEs are the main or only type of business in that region. (12) As a response to the possible withdrawal of the United Kingdom from the Union without a withdrawal agreement, Regulation (EU) 2019/1796 of the European Parliament and of the Council (9) amended Regulation (EU) No 1309/2013 to specify that redundancies resulting from such a withdrawal would fall within the scope of the Fund. Due to the withdrawal of the United Kingdom with a withdrawal agreement, that Regulation did not apply. (13) The Commission carried out a mid-term evaluation of the Fund to assess how and to what extent it had achieved its objectives. The Fund proved to be effective, attaining a higher reintegration rate of displaced workers than in the previous programming period. The evaluation also found that the Fund generated Union added value. This is particularly true in terms of its volume effects, meaning that Fund assistance not only increased the number and variety of services offered, but also the level of intensity of those services. Moreover, the Fund interventions had high visibility and demonstrated the Union added value directly to the public. However, several challenges were identified. The mobilisation procedure was considered to be too long. In addition, many Member States reported problems in putting together the extensive background analysis of the event that triggered the redundancies. The main reason why Member States were discouraged from applying for support from the Fund were financial and institutional capacity problems. This could simply be due to a lack of personnel: currently, Member States can ask for technical assistance only once they implement the Fund support. Since redundancies can happen unexpectedly, it is important to ensure that Member States are ready to react immediately and are able to submit an application without delay. Moreover, in certain Member States, more profound institutional capacity-building efforts seem to be necessary in order to ensure the efficient and effective implementation of EGF cases. Moreover, the threshold of 500 displaced jobs has been criticised as being too high, especially in less-populated regions. (14) The EGF\u2019s role continues to be important as a flexible instrument to support workers who lose their jobs in large-scale restructuring events and to help them to find other jobs as quickly as possible. The Union should continue to provide specific, one-off support to facilitate the reintegration into decent and sustainable employment of displaced workers in areas, sectors, territories or labour markets suffering a shock of serious economic disruption. Considering the interplay and mutual effects of open trade and economic and financial developments such as asymmetric economic shocks, technological change, digitisation, significant changes in the trade relations of the Union or the composition of the internal market, as well as other factors including the transition to a low-carbon economy, and considering the fact that it is increasingly difficult to single out a specific factor that causes job displacements, the mobilisation of the EGF should be based only on the significant impact of a restructuring event. Given the purpose of the EGF, which is to provide support in emergencies, complementing the more anticipatory assistance offered by ESF+, the EGF should remain a flexible and special instrument outside the budgetary ceilings of the MFF, as set out in the Commission communication entitled \u2018A Modern Budget for a Union that Protects, Empowers and Defends The Multiannual Financial Framework for 2021-2027\u2019 of 2 May 2018 and the Annex thereto. (15) In order to retain the European nature of the EGF, an application for support should be triggered when a major restructuring event has a significant impact on the local or regional economy. Such an impact should be determined by reference to a minimum number of job displacements within a specific reference period. Taking into account the findings of the mid-term evaluation, the threshold should be set at 200 job displacements within a reference period of four months (or six months in sectoral cases). Considering that waves of dismissals in different sectors within the same region have an equally significant impact on the local labour market, regional applications should also be possible. In small labour markets, such as in small Member States or remote regions, including the outermost regions as referred in Article 349 TFEU, or in exceptional circumstances, it should be possible for applications to be submitted in cases with a lower number of job displacements. In general, Member State should not submit their applications for EGF assistance later than 12 weeks after the end of the reference period. However, in order to prevent a funding gap due to the fact that this Regulation will enter into force after 1 January 2021 and in order to provide legal certainty, that time limit should be suspended between 1 January 2021 and the entry into force of this Regulation. (16) The EGF, as a fund designed for major restructuring events, should not be mobilised in cases of dismissal in the public sector which are the consequence of budgetary cuts. However, the EGF should be able to support workers displaced from enterprises active on a competitive market that provide goods or services to publicly financed entities affected by budgetary cuts. The EGF should also be able to support self-employed persons whose activity has ceased as a result of budgetary cuts. (17) In order to express Union solidarity towards unemployed persons, the co-financing rate of the EGF, as a reactive fund, should be aligned with the highest co-financing rate of ESF+, as a proactive fund, in the Member State concerned, but in any case should not be lower than 60 %. (18) Part of the budget of the Union allocated to the EGF should be implemented by the Commission under shared management with Member States within the meaning of the Financial Regulation. Therefore, when implementing the EGF under shared management, the Commission and the Member States should respect the principles referred to in the Financial Regulation, such as sound financial management, transparency and non-discrimination. (19) The European Monitoring Centre on Change, which is based in the European Foundation for the Improvement of Living and Working Conditions in Dublin, assists the Commission and the Member States with qualitative and quantitative analyses in order to help in the assessment of trends of globalisation, technological and environmental changes, restructuring and the use of the EGF. The European Restructuring Monitor, updated on a daily basis, follows the reporting of large-scale restructuring events throughout the Union, on the basis of a network of national correspondents. It could help identify potential cases for intervention at an early stage. (20) Displaced workers and self-employed persons whose activity has ceased should have equal access to the EGF, independently of their type of employment contract or relationship. Therefore, displaced workers and self-employed persons whose activity has ceased should be regarded as possible EGF beneficiaries for the purposes of this Regulation. (21) Financial contributions from the EGF should be primarily directed at active labour market policy measures and personalised services that aim to reintegrate beneficiaries rapidly into decent and sustainable employment within or outside their initial sector of activity, while preparing them for a greener and more digital European economy. The support should also seek to promote self-employment and enterprise creation, including through the establishment of cooperatives. Measures should reflect the prospective needs of the local or regional labour market. However, where relevant, the mobility of displaced workers should also be supported in order to help them find new employment elsewhere. There should be a particular focus on the dissemination of skills required in the digital age and on overcoming gender stereotypes in employment, where appropriate. The inclusion of pecuniary allowances in coordinated packages of personalised services should be restricted. The measures supported by the EGF should not replace passive social protection measures. Employers could be encouraged to participate in the national co-funding for the EGF-supported measures in addition to the measures which they are required to provide by virtue of national law or collective agreements. (22) When implementing and designing a coordinated package of personalised services aiming to facilitate the reintegration of the targeted beneficiaries, Member States should address the objectives of the Digital Agenda and the Digital Single Market Strategy. Particular attention should be paid to the gender pay gap within the sectors of information and communication technologies (ICT) and science, technology, engineering and mathematics (STEM) by promoting the retraining and requalification of women into those sectors. When implementing and designing a coordinated package of personalised services, Member States should aim to increase the representation of the less represented gender, thus contributing towards the reduction of the gender pay gap and the pension gap. (23) Given that the digital transformation of the economy requires a certain level of digital competence of the workforce, the dissemination of skills required in the digital age should be considered to be a horizontal element of any coordinated package of personalised services offered. (24) When drawing up active labour market policy measures, Member States should favour measures that significantly contribute to the employability of the beneficiaries. Member States should strive towards the reintegration into sustainable employment of the largest possible number of beneficiaries participating in these measures as soon as possible within six months of the end of the implementation period. The design of the coordinated package of personalised services should take into account the reasons for the redundancies where relevant and anticipate future labour market perspectives and required skills. The coordinated package of personalised services should be compatible with the transition towards a resource-efficient and sustainable economy. (25) When drawing up active labour market policy measures, Member States should pay particular attention to disadvantaged beneficiaries, including persons with disabilities, persons with dependent relatives, young and older unemployed persons, persons with a low level of qualifications, persons with a migrant background and persons at risk of poverty, given that those groups experience particular problems in re-entering the labour market. Nevertheless, the principles of gender equality and of non-discrimination, which are among the Union\u2019s core values and are enshrined in the Pillar, should be respected and promoted when implementing the EGF. (26) In order to support beneficiaries effectively and rapidly, Member States should do their utmost to submit complete applications when applying for a financial contribution from the EGF. Where the Commission requires further information for the assessment of an application, the provision of such information should be subject to a deadline. Both Member States and the Union institutions should aim to process applications as quickly as possible. (27) In the interests of the beneficiaries and the bodies responsible for implementation of the measures, the applicant Member State should keep all actors involved in the application procedure informed of the progress of the application and should engage them where possible during the implementation of measures. (28) In compliance with the principle of sound financial management, financial contributions from the EGF should not replace support measures which are available for beneficiaries within the Union funds or other Union policies or programmes, but should, where possible, complement such measures. (29) Special provisions should be included for information and communication actions on EGF cases and outcomes. Member States and EGF stakeholders should raise awareness of the achievements of Union funding by informing the public. Transparency and communication activities are essential in making Union action visible on the ground and should be based on accurate and up-to-date information. With the aim of promoting the EGF and demonstrating its added value as part of the Union budget, communication and visibility material developed by Member States should be made available to Union institutions, bodies or agencies upon request. Therefore, a royalty-free, non-exclusive and irrevocable licence to use such material and any pre-existing rights attached to it should be granted to the Union. (30) To facilitate the implementation of this Regulation, expenditure should be eligible for a financial contribution from the EGF either from the date on which a Member State starts to provide personalised services or from the date on which a Member State incurs administrative expenditure in implementing the EGF. (31) In order to cover needs that arise, especially during the first months of each year, when the possibilities for transfers from other budget lines are particularly difficult, an adequate amount of payment appropriations should be made available on the EGF budget line in the annual budgetary procedure. (32) The MFF 2021-2027 and the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (10) determine the budgetary framework of the EGF. (33) In the interests of the beneficiaries, assistance should be made available as quickly and efficiently as possible. The Member States and the Union institutions involved in the EGF decision-making process should do their utmost to reduce processing time and simplify procedures so as to ensure the smooth and rapid adoption of decisions on the mobilisation of the EGF. (34) SMEs are the backbone of the Union\u2019s economy. Therefore, promoting entrepreneurship and supporting SMEs is key to ensuring economic growth, innovation, job creation and social integration. The Union actively promotes entrepreneurship by encouraging people to start their own business. In the case of major restructuring events, it should be possible to help displaced workers to launch their own business. In the event of an enterprise closing down, it should also be possible to help displaced workers to take over some or all of the activities of their former employer. (35) For transparency and information purposes, Member States should disclose in the final reports details of any State aid or Union funding that the enterprise dismissing the workers received in the five years preceding the report. However, this requirement should not apply to microenterprises or SMEs, in particular start-ups and scale-ups, in order to avoid any disproportionate administrative burden on Member States, particularly in the case of sectoral EGF applications involving more than one microenterprise or SME. (36) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 for Better Law-Making (11), the EGF should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the EGF on the ground. (37) In order to enable political scrutiny by the European Parliament and continuous monitoring by the Commission of results obtained with EGF assistance, the Member States concerned should submit a final report on the implementation of the EGF. (38) Member States should support the Commission in carrying out evaluations by providing relevant data at their disposal. (39) In order to facilitate future evaluations, a beneficiary survey should be conducted after the implementation of each financial contribution from the EGF. The beneficiary survey should be open to participants for at least four weeks and should be launched during the sixth month after the end of the implementation period. Member States should assist the Commission in conducting the beneficiary survey, encouraging beneficiaries to participate by sending out the invitation to take part and at least one reminder. Member States should inform the Commission about the efforts made to contact the beneficiaries. The Commission should use the collected data for evaluation purposes. To ensure comparability between cases, the Commission should design the beneficiary survey template in close cooperation with the Member States and should provide translation into all official languages of the institutions of the Union. (40) In accordance with the objective of eliminating inequalities and promoting equality between men and women, analyses and reports related to the EGF should include gender-disaggregated information. (41) A list of indicators should be set out in an annex to this Regulation for the purpose of monitoring the use of the EGF and, in particular, progress towards the achievement of its objectives. Where necessary, the Commission may submit a legislative proposal to amend those indicators. (42) The Member States should remain responsible for the implementation of the financial contribution and for the management and control of the actions supported by Union funding, in accordance with the relevant provisions of the Financial Regulation. The Member States should justify the use made of the financial contribution received from the EGF. In view of the short implementation period for EGF interventions, reporting obligations should reflect the particular nature of those interventions. (43) Member States should prevent, detect and deal effectively with any irregularities, including fraud, committed by beneficiaries. Moreover, in accordance with Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (12) and Council Regulations (EC, Euratom) No 2988/95 (13) and (Euratom, EC) No 2185/96 (14), the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Council Regulation (EU) 2017/1939 (15), to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (16). Member States should take the necessary measures to ensure that any person or entity receiving Union funds fully cooperates in the protection of the financial interests of the Union, grants the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensures that any third parties involved in the implementation of Union funds grant equivalent rights. Member States should report to the Commission any irregularities detected, including fraud, and any follow-up action they have taken with regard to such irregularities and with regard to any OLAF investigations. Member States should cooperate with the Commission, OLAF, the Court of Auditors and, where applicable, the EPPO, in accordance with point (d) of Article 63(2) of the Financial Regulation on all matters related to suspected or established fraud. (44) To enhance the protection of the Union\u2019s budget, the Commission should make available an integrated and interoperable information and monitoring system including a single data-mining and risk-scoring tool to access and analyse the relevant data, and the Commission should encourage its use with a view to generalised application by Member States. (45) The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (46) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement, and the commitment to the UN Sustainable Development Goals, the actions under this Regulation should contribute to the achievement of a target of 30 % of the Union budget expenditure supporting climate objectives and the ambition of 7,5 % of the Union budget reflecting biodiversity expenditures in 2024 and 10 % in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. (47) In order to allow better monitoring of the use of the EGF, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in order to supplement this Regulation by setting out the criteria for determining the cases of irregularity to be reported and the data to be provided by Member States for the purpose of preventing, detecting and correcting irregularities, including fraud and recovering amounts unduly paid together with interest on late payments. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (48) In order to ensure uniform conditions for the implementation of this Regulation with regard to the conduct of beneficiary surveys and the format for reporting irregularities, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (17). (49) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (50) In order to ensure continuity in providing support in the relevant policy area and to allow implementation as of the beginning of the MFF 2021 to 2027, it is necessary to provide for the application of this Regulation from the beginning of the 2021 financial year. However, the Commission should initiate the budgetary procedure only upon the entry into force of this Regulation. (51) Regulation (EU) No 1309/2013 should therefore be repealed, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. This Regulation establishes the European Globalisation Adjustment Fund for Displaced Workers (EGF) for the period of the MFF 2021 to 2027. It lays down the objectives of the EGF, the forms of Union funding and the rules for providing such funding, including applications by the Member States for financial contributions from the EGF for measures targeting the beneficiaries referred to in Article 6. 2. In accordance with Article 4, the EGF shall offer support to displaced workers and self-employed persons whose activity has ceased in the course of major restructuring events. Article 2 Mission and objectives 1. The EGF shall support socioeconomic transformations that are the result of globalisation and of technological and environmental changes by helping displaced workers and self-employed persons whose activity has ceased to adapt to structural change. The EGF shall constitute an emergency fund that operates reactively. As such, the EGF shall contribute to the implementation of the principles set out in the European Pillar of Social Rights and shall enhance social and economic cohesion among regions and Member States. 2. The objectives of the EGF are to demonstrate solidarity and promote decent and sustainable employment in the Union by offering assistance in the case of major restructuring events, in particular those caused by challenges related to globalisation, such as changes in world trade patterns, trade disputes, significant changes in the trade relations of the Union or the composition of the internal market and financial or economic crises, as well as the transition to a low-carbon economy, or as a consequence of digitisation or automation. The EGF shall support beneficiaries in returning to decent and sustainable employment as soon as possible. Particular emphasis shall be placed on measures that help the most disadvantaged groups. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018displaced worker\u2019 means a worker, regardless of the type or duration of his or her employment relationship, whose employment contract or relationship is ended prematurely by redundancy, or whose employment contract or relationship is not renewed, for economic reasons; (2) \u2018self-employed person\u2019 means a natural person who employs fewer than 10 workers; (3) \u2018beneficiary\u2019 means a natural person who participates in EGF co-funded measures; (4) \u2018irregularity\u2019 means a breach of applicable law, resulting from an act or omission by an economic operator involved in the implementation of the EGF, which has, or would have, the effect of prejudicing the budget of the Union by charging unjustified expenditures to that budget; (5) \u2018implementation period\u2019 means the period beginning on the dates referred to in point (j) of Article 8(7) and ending 24 months after the date of entry into force of the decision on the financial contribution pursuant to Article 15(2). Article 4 Intervention criteria 1. Member States may apply for financial contributions from the EGF for measures targeting displaced workers and self-employed persons in accordance with the provisions laid down in this Article. 2. In the case of major restructuring events, a financial contribution from the EGF shall be provided where one of the following circumstances applies: (a) the cessation of activity of at least 200 displaced workers or self-employed persons, over a reference period of four months, in an enterprise in a Member State, including where that cessation of activity applies to its suppliers or downstream producers; (b) the cessation of activity of at least 200 displaced workers or self-employed persons, over a reference period of six months, particularly in SMEs, where all operate in the same economic sector defined at NACE Revision 2 division level and are located in one region or two contiguous regions defined at NUTS 2 level or in more than two contiguous regions defined at NUTS 2 level provided that there are at least 200 workers or self-employed persons affected in two of the regions combined; (c) the cessation of activity of at least 200 displaced workers or self-employed persons, over a reference period of four months, particularly in SMEs, where all operate in the same or different economic sectors defined at NACE Revision 2 division level and located in the same region defined at NUTS 2 level. 3. In small labour markets, in particular with regard to applications involving SMEs, where duly substantiated by the applicant Member State, an application for a financial contribution under this Article shall be considered to be admissible even if the criteria laid down in paragraph 2 are not entirely met, provided that the redundancies have a serious impact on employment and the local, regional or national economy. In such cases, the applicant Member State shall specify which of the intervention criteria set out in paragraph 2 are not entirely met. 4. In exceptional circumstances, paragraph 3 shall also apply to labour markets other than small labour markets. The aggregated amount of financial contributions in such cases shall not exceed 15 % of the annual ceiling of the EGF. 5. The EGF shall not be mobilised where public-sector employees are dismissed as a result of budgetary cuts by a Member State. Article 5 Calculation of displacements and of cessation of activity The applicant Member State shall specify the method used for calculating the number of displaced workers and self-employed persons for the purpose of Article 4 as at one or more of following dates: (a) the date on which the employer notifies the competent public authority in writing of the projected collective redundancies in accordance with Article 3(1) of Council Directive 98/59/EC (18); (b) the date of the employer\u2019s individual notice to make the worker redundant or to terminate the employment contract or relationship of the worker; (c) the date of the de facto termination or the expiry of the employment contract or relationship; (d) the date of the end of the assignment of the worker to the user undertaking; (e) with regard to self-employed persons, the date of cessation of the activities as determined in accordance with national law or administrative provisions. In the cases referred to in point (a) of the first paragraph of this Article, the applicant Member State shall provide the Commission with additional information about the actual number of redundancies effected in accordance with Article 4, prior to the completion of the assessment by the Commission. Article 6 Eligible beneficiaries The applicant Member State may provide eligible beneficiaries with a coordinated package of personalised services (\u2018coordinated package\u2019) in accordance with Article 7 that is co-financed by the EGF. Such eligible beneficiaries may include: (a) displaced workers and self-employed persons whose activity has ceased, determined in accordance with Article 5, within the reference periods provided for in Article 4(1) to (4); (b) displaced workers and self-employed persons whose activity has ceased, determined in accordance with Article 5, outside the reference period provided for in Article 4, namely six months before the start of the reference period or between the end of the reference period and the last day before the date of the completion of the assessment by the Commission. Workers and self-employed persons as referred to in point (b) of the first paragraph shall be considered to be eligible beneficiaries provided that a clear causal link can be established with the event which triggered the redundancies during the reference period. Article 7 Eligible measures 1. A financial contribution from the EGF may be made for active labour market policy measures that form part of a coordinated package, designed to facilitate the reintegration of the targeted beneficiaries, in particular the most disadvantaged among them, into employment or self-employment. 2. Given the importance of skills required in the digital industrial age and in a resource-efficient economy, the dissemination of such skills shall be considered to be a horizontal element for the design of coordinated packages. The need for and level of training shall be adapted to the qualifications and skills of each beneficiary. The coordinated package may include: (a) tailor-made training and retraining, including with regard to information and communication technology and other skills required in the digital age, certification of acquired knowledge and skills, individual job-search assistance services and targeted group activities, occupational guidance, advisory services, mentoring, outplacement assistance, entrepreneurship promotion, aid for self-employment, business creation, employee take-overs, and cooperation activities; (b) special time-limited measures, such as job-search allowances, employers\u2019 recruitment incentives, mobility allowances, childcare allowances, training allowances, subsistence allowances, and allowances for carers. The costs of the measures referred to in point (b) of the second subparagraph shall not exceed 35 % of the total cost of the coordinated package. The investments for self-employment, business creation and employee take-overs shall not exceed EUR 22 000 per beneficiary. The design of the coordinated package shall anticipate future labour market perspectives and required skills. The coordinated package shall be compatible with the shift towards a resource-efficient and sustainable economy, shall focus on the dissemination of skills required in the digital industrial age, and shall take into account the demand on the local labour market. 3. The following measures shall not be eligible for a financial contribution from the EGF: (a) special time-limited measures, as referred to in point (b) of the second subparagraph of paragraph 2, if those measures are not conditional on the active participation of the targeted beneficiaries in job-search or training activities; (b) measures which are the responsibility of enterprises by virtue of national law or collective agreements. The measures supported by the EGF shall not replace passive social protection measures. 4. The coordinated package shall be drawn up in consultation with the targeted beneficiaries, their representatives or the social partners, as applicable. 5. At the initiative of the applicant Member State, a financial contribution from the EGF may be made for preparatory, management, information and publicity, and control and reporting activities. Article 8 Applications 1. The applicant Member State shall submit an application for a financial contribution from the EGF to the Commission within 12 weeks of the date on which the criteria set out in Article 4(2), (3) or (4) are met. 2. The time limit referred to in paragraph 1 shall be suspended between 1 January 2021 and 3 May 2021. 3. If requested by the applicant Member State, the Commission shall provide guidance throughout the application procedure. 4. Within 10 working days of the date of submission of the application, or, where applicable, within 10 working days of the date on which the Commission is in possession of a translation of the application, whichever is the later, the Commission shall acknowledge receipt of the application and request from the applicant Member State any additional information that it requires in order to assess the application. 5. Where the Commission requests additional information, the Member State shall reply within 15 working days of the date of the request. The Commission shall extend that deadline by 10 working days at the request of the applicant Member State. Any such requests for extension shall be duly reasoned. 6. On the basis of the information provided by the applicant Member State, the Commission shall complete its assessment of the compliance of the application with the conditions for providing a financial contribution within 50 working days of the receipt of the complete application or, where applicable, of the translation of the application. Where the Commission is not able to meet that deadline, it shall inform the applicant Member State before that deadline, explaining the reasons for the delay and setting a new date for the completion of its assessment. That new date shall be no later than 20 working days after the deadline under the first subparagraph. 7. An application shall contain the following information: (a) an assessment of the number of redundancies in accordance with Article 5, as well as the method of calculation; (b) where the dismissing enterprise has continued its activities after the redundancies, confirmation that it has complied with its legal obligations governing those redundancies and has provided for its workers accordingly; (c) an explanation of the extent to which the recommendations set out in the EU Quality Framework for anticipation of change and restructuring were taken into account, and how the coordinated package complements actions funded by other Union or national funds, including information about measures that are mandatory for the dismissing enterprises concerned by virtue of national law or collective agreements, and information about the activities already undertaken by the Member State for the assistance of displaced workers; (d) a brief description of the events that led to the displacement of the workers; (e) where applicable, the identification of the dismissing enterprises, suppliers or downstream producers and sectors; (f) an estimated breakdown of the composition of the targeted beneficiaries by gender, age group and educational level, used in the design of the coordinated package; (g) the expected impact of the redundancies as regards the local, regional or national economy and employment; (h) a detailed description of the coordinated package and related expenditure, including, in particular, any measures in support of employment initiatives for disadvantaged, young and older beneficiaries; (i) the estimated budget for each of the components of the coordinated package in support of the targeted beneficiaries and for any preparatory, management, information and publicity, control and reporting activities; (j) the dates on which the provision of the coordinated package to the targeted beneficiaries and the activities to implement the EGF, as set out in Article 7, were started or are due to be started; (k) the procedures followed for consulting the targeted beneficiaries or their representatives or the social partners as well as local and regional authorities or other relevant stakeholders as applicable; (l) a statement that the requested EGF support complies with the procedural and material Union rules on State aid as well as a statement outlining why thecoordinated package does not replace measures that are the responsibility of employers by virtue of national law or collective agreements; (m) the sources of national pre-financing or national co-funding and other co-funding, if applicable. Article 9 Complementarity, compliance and coordination 1. A financial contribution from the EGF shall not replace measures which are the responsibility of employers by virtue of national law or collective agreements. 2. Support for targeted beneficiaries shall complement measures of the Member States at national, regional and local level, including such measures that also receive other financial support from the Union budget, in line with the recommendations set out in the EU Quality Framework for anticipation of change and restructuring. 3. The financial contribution from the EGF shall be limited to what is necessary to provide temporary, one-off support for targeted beneficiaries. The measures supported by the EGF shall comply with Union and national law, including State aid rules. 4. In accordance with their respective responsibilities, the Commission and the applicant Member State shall ensure the coordination of the assistance from other financial support from the Union budget. 5. The applicant Member State shall ensure that the specific measures receiving a financial contribution from the EGF do not receive other financial support from the Union budget. Article 10 Equality between men and women, and non-discrimination The Commission and the Member States shall ensure that equality between men and women and the integration of the gender perspective are an integral part of and are promoted throughout the implementation period. The Commission and the Member States shall take all appropriate steps to prevent any discrimination based on gender, gender identity, racial or ethnic origin, religion or belief, disability, age or sexual orientation in access to the EGF and during the various stages of the implementation period. Article 11 Technical assistance at the initiative of the Commission 1. At the initiative of the Commission, a maximum of 0,5 % of the annual ceiling of the EGF may be used for technical and administrative expenditure for its implementation, such as preparatory, monitoring, control, audit and evaluation activities, as well as data gathering, including in relation to corporate information technology systems, communication activities and those enhancing the EGF\u2019s visibility as a fund or with regard to specific projects and other technical assistance measures. Such measures may cover future and previous programming periods. 2. Subject to the ceiling set out in paragraph 1 of this Article, the Commission shall submit a request for a transfer of appropriations for technical assistance to the relevant budgetary lines in accordance with Article 31 of the Financial Regulation. 3. The Commission shall implement technical assistance at its own initiative under direct or indirect management in accordance with points (a) and (c) of Article 62(1) of the Financial Regulation. Where the Commission implements technical assistance under indirect management, it shall ensure a transparent procedure for designating the third party responsible for carrying out the tasks assigned to it in accordance with the Financial Regulation. It shall inform the European Parliament and the Council as well as the public of the subcontractor selected for that purpose. 4. The Commission\u2019s technical assistance shall include the provision of information and guidance to the Member States on using, monitoring and evaluating the EGF. The Commission shall also provide information along with clear guidance to the social partners at Union and national level on the use of the EGF. Guidance measures may also include the creation of taskforces in cases of severe economic disruptions in a Member State. Article 12 Information, communication and publicity 1. The Member States shall acknowledge the origin and ensure the visibility of the Union funding and highlight the Union added value of the intervention, by providing coherent, effective and targeted information to multiple audiences, including targeted information to beneficiaries, local and regional authorities, the social partners, the media and the public. Member States shall use the EU emblem in accordance with Annex IX to the Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the \u2018Common Provisions Regulation for 2021-2027\u2019) together with the simple funding statement, \u2018co-funded by the European Union\u2019. 2. The Commission shall maintain and update regularly an online presence, accessible in all official languages of the institutions of the Union, to provide updated information about the EGF, guidance on the submission of applications, examples of eligible measures and a regularly updated list of Member State contacts as well as information about accepted and rejected applications and on the role of the European Parliament and the Council in the budgetary procedure. 3. The Commission shall promote the broad dissemination of existing best practices and shall carry out information and communication actions with the aim of raising the awareness of Union citizens and workers, including people who have difficulties in accessing information, of the EGF. The Member States shall ensure that communication and visibility material is made available upon request to Union institutions, bodies or agencies and that a royalty-free, non-exclusive and irrevocable licence to use such material and any pre-existing rights attached to it is granted to the Union, to publicise the EGF or in relation to reporting on the use of the Union budget. That obligation shall not require Member States to take on significant additional costs or significant administrative burdens. The licence shall grant the Union the rights set out in Annex I. 4. The resources allocated to communication actions under this Regulation shall also contribute to covering the corporate communication of the political priorities of the Union provided that such priorities are related to the objectives laid down in Article 2. Article 13 Determination of the financial contribution 1. On the basis of the assessment carried out in accordance with Article 8, in particular taking into account the number of targeted beneficiaries, the proposed measures and the estimated costs, the Commission shall evaluate and propose the amount of a financial contribution from the EGF, if any, that may be made within the limits of the resources available. The Commission shall complete its evaluation and submit its proposal by the deadline laid down in Article 8(6). 2. The co-financing rate of the EGF for the measures offered shall be the highest co-financing rate of ESF+ in the relevant Member State, as set out in Article 112(3) of the Common Provisions Regulation for 2021-2027 or 60 %, whichever is the higher. 3. Where, on the basis of the assessment carried out in accordance with Article 8, the Commission concludes that the conditions for a financial contribution under this Regulation are met, it shall immediately initiate the procedure set out in Article 15. 4. Where, on the basis of the assessment carried out in accordance with Article 8, the Commission concludes that the conditions for a financial contribution under this Regulation are not met, it shall immediately notify the applicant Member State, the European Parliament and the Council. Article 14 Eligibility period 1. Expenditure shall be eligible for a financial contribution from the EGF from the dates set out in the application in accordance with point (j) of Article 8(7) on which the Member State concerned starts, or is due to start, providing the coordinated package to the targeted beneficiaries or on which it incurs the administrative expenditure to implement the EGF in accordance with Article 7(1) and (5). 2. The Member State shall start implementing the eligible measures set out in Article 7 without undue delay and shall carry out those measures as soon as possible, and in any event within 24 months of the date of entry into force of the decision on the financial contribution. 3. Where a beneficiary accesses an education or training course the duration of which is at least two years, the expenditure for that course shall be eligible for EGF co-funding up to the date on which the final report referred to in Article 20(1) is due, provided that the relevant expenditure is incurred before that date. 4. Expenditure pursuant to Article 7(5) shall be eligible for EGF co-funding until the deadline for submission of the final report in accordance with Article 20(1). Article 15 Budgetary procedure and implementation 1. Where the Commission has concluded that the conditions for providing a financial contribution from the EGF are met, it shall submit a proposal to mobilise the EGF to the European Parliament and to the Council. The decision to mobilise the EGF shall be taken jointly by the European Parliament and the Council within six weeks of the submission of the Commission\u2019s proposal to them. At the same time as it submits its proposal for a decision to mobilise the EGF, the Commission shall submit to the European Parliament and to the Council a proposal for a transfer to the relevant budgetary lines. Transfers related to the EGF shall be made in accordance with Article 31 of the Financial Regulation. 2. The Commission shall adopt a decision on a financial contribution, which shall enter into force on the date on which the Commission is notified of the approval of the budgetary transfer by the European Parliament and the Council. That decision shall constitute a financing decision within the meaning of Article 110 of the Financial Regulation. 3. A proposal for a decision to mobilise the EGF pursuant to paragraph 1 shall include the following: (a) the assessment carried out in accordance with Article 8(6), together with a summary of the information on which that assessment is based; and (b) the reasons justifying the amounts proposed in accordance with Article 13(1). Article 16 Insufficient funds By way of derogation from the deadlines set out in Articles 8 and 15, in exceptional cases and provided that the remaining commitment appropriations available in the EGF are not sufficient to cover the amount of assistance that is necessary according to the Commission proposal, the Commission may postpone the proposal to mobilise the EGF and the subsequent budgetary transfer request until commitment appropriations are available in the following year. The annual budgetary ceiling of the EGF shall be respected in all circumstances. Article 17 Payment and use of the financial contribution 1. The Commission shall pay the financial contribution to the Member State concerned in a single 100 % pre-financing payment, in principle within 15 working days of the entry into force of a decision on a financial contribution in accordance with Article 15(2). The pre-financing shall be cleared once the Member State submits the certified statement of expenditure in accordance with Article 20(1). The unspent amount shall be reimbursed to the Commission. 2. The financial contribution referred to in paragraph 1 of this Article shall be implemented under shared management in accordance with Article 63 of the Financial Regulation. 3. Detailed technical terms of the financing shall be determined by the Commission in the decision on a financial contribution referred to in Article 15(2). 4. When carrying out the measures contained in the coordinated package, the Member State concerned may submit a proposal to the Commission to amend the actions by adding other eligible measures as listed in points (a) and (b) of Article 7(2), provided that such amendments are duly justified and the total does not exceed the financial contribution referred to in Article 15(2). The Commission shall assess the proposed amendments and, if it agrees, shall amend the decision on the financial contribution accordingly. 5. The Member State concerned may reallocate amounts between the budget items laid down in the decision on a financial contribution pursuant to Article 15(2). If such a reallocation exceeds a 20 % increase for one or more of the items specified, the Member State shall notify the Commission beforehand. Article 18 Use of the euro Amounts referred to in applications, decisions on financial contributions and reports under this Regulation, as well as any other related documents, shall be expressed in euro. Article 19 Indicators 1. Indicators to report on the progress of the EGF towards the achievement of the objectives laid down in Article 2 are set out in Annex II. Personal data relating to those indicators shall be collected on the basis of this Regulation solely for the purposes of this Regulation. They shall be processed in compliance with Regulation (EU) 2016/679 of the European Parliament and of the Council (19). 2. The performance reporting system shall ensure that data for monitoring the implementation and the results of the EGF are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements shall be imposed on Member States. Article 20 Final report and closure 1. Not later than at the end of the seventh month after the expiry of the implementation period, the Member State concerned shall present a final report to the Commission on the implementation of the relevant financial contribution, including information about: (a) the type of measures and results, explaining the challenges, the lessons learned, synergies and complementarities with other Union funds, particularly ESF+, and indicating, where possible, the complementarity of the measures with measures funded by other Union or national programmes in line with the EU Quality Framework for anticipation of change and restructuring; (b) the names of the bodies that delivered the coordinated package in the Member State; (c) the indicators set out in points (1) and (2) of Annex II; (d) whether the dismissing enterprise, except where it is a microenterprise or an SME, has been a beneficiary of State aid or previous funding from Union cohesion or structural funds in the preceding five years; and (e) a statement justifying the expenditure. 2. No later than six months after the Commission has received all the information required under paragraph 1 of this Article, it shall wind up the financial contribution by determining the final amount of the financial contribution from the EGF and the balance due, if any, by the Member State concerned in accordance with Article 24. Article 21 Biennial report 1. By 1 August 2021 and every two years thereafter, the Commission shall submit to the European Parliament and to the Council a comprehensive, quantitative and qualitative report on the activities under this Regulation and Regulation (EU) No 1309/2013 in the preceding two years. The report shall focus mainly on the results achieved by the EGF and in particular shall contain information relating to applications submitted, processing time, decisions adopted, measures funded, including statistics on the indicators set out in Annex II, and the complementarity of such measures with measures funded by other Union funds, in particular ESF+, and information relating to the winding-up of financial contributions made. The report shall also document applications that have been rejected due to non-eligibility or for which the amount has been reduced due to insufficient appropriations. 2. The report shall also be submitted for information to the Court of Auditors, the European Economic and Social Committee, the Committee of the Regions and the social partners. Article 22 Evaluations 1. On its own initiative and in close cooperation with the Member States, the Commission shall carry out: (a) a mid-term evaluation by 30 June 2025; and (b) a retrospective evaluation by 31 December 2029. 2. The results of the evaluations referred to in paragraph 1 shall be submitted to the European Parliament, the Council, the Court of Auditors, the European Economic and Social Committee, the Committee of the Regions and the social partners for information. The recommendations of the evaluations shall be taken into account for the design of new programmes in the area of employment and social affairs or the further development of existing programmes. 3. The evaluations referred to in paragraph 1 shall include relevant statistics on the financial contributions, broken down by sector and Member State. 4. A beneficiary survey shall be launched during the sixth month after the end of each implementation period. The beneficiary survey shall be open to participation for at least four weeks. Member States shall distribute the beneficiary survey to the beneficiaries, send out at least one reminder and inform the Commission of the distribution and reminder sent. The responses to the beneficiary surveys shall be collated and analysed by the Commission for the use in future evaluations. 5. Beneficiary surveys shall be used to collect data on the perceived change in the employability of beneficiaries, or, for those who have already found employment, on the quality of the employment found, such as changes in working hours, the type of employment contract or relationship (full time or part time; fixed term or open-ended), the level of responsibility or change of salary level in comparison to previous employment, and the sector in which the person found employment. That information shall be broken down by gender, age group, education level and level of professional experience. 6. In order to ensure uniform conditions for the implementation of this Article, the Commission shall adopt an implementing act setting out when and how a beneficiary survey is to be conducted and the template to be used. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 26(2). Article 23 Management and financial control 1. Without prejudice to the Commission\u2019s responsibility for implementing the general budget of the Union, Member States shall take responsibility for the management of measures supported by the EGF and for the financial control of the measures. They shall take at least the following steps: (a) verifying that management and control arrangements have been set up and are being implemented in such a way as to ensure that Union funds are being used efficiently and correctly, in accordance with the principle of sound financial management; (b) ensuring that the delivery of monitoring data is a mandatory requirement in contracts with bodies delivering the coordinated packages; (c) verifying that the financed measures have been properly carried out; (d) ensuring that expenditure funded is based on verifiable supporting documents, and is legal and regular; (e) preventing, detecting and correcting irregularities including fraud and recovering amounts unduly paid together with interest on late payments where appropriate. The Member States shall report irregularities including fraud, as referred to in point (e) of the first subparagraph, to the Commission. 2. Member States shall ensure the legality and regularity of expenditure included in the accounts submitted to the Commission and shall take all required actions to prevent, detect and correct and report on irregularities, including fraud. Such actions shall include the collection of information about the beneficial owners of the recipients of funding in accordance with Annex XVII to the Common Provisions Regulation for 2021-2027. The rules related to the collection and processing of such data shall comply with applicable data protection rules. The Commission, OLAF and the Court of Auditors shall have the necessary access to that information. 3. For the purposes of Article 63(3) of the Financial Regulation, Member States shall identify bodies responsible for the management and control of the measures supported by the EGF. Those bodies shall provide the Commission with the information set out in Article 63(5), (6) and (7) of the Financial Regulation on the implementation of the financial contribution when submitting the final report referred to in Article 20(1) of this Regulation. Where authorities designated in accordance with Regulation (EU) No 1309/2013 have provided sufficient guarantees that payments are legal and regular, and properly accounted for, the Member State concerned may notify to the Commission that those authorities are confirmed under this Regulation. On making such a notification, that Member State shall indicate which authorities are confirmed and their functions. 4. Member States shall make the required financial corrections where an irregularity is ascertained. The corrections made by the Member States shall consist of cancelling all or part of the financial contribution. The Member States shall recover any amount unduly paid as a result of an irregularity detected and repay that amount to the Commission. Where the amount is not repaid by the relevant Member State in the time allowed, default interest shall be due. 5. The Commission, in its responsibility for the implementation of the general budget of the Union, shall take every step necessary to verify that the actions financed are carried out in accordance with the principle of sound financial management. It is the responsibility of the Member State concerned to ensure that it has smoothly functioning management and control systems. The Commission shall satisfy itself that such systems are in place. To that end, without prejudice to the powers of the Court of Auditors or the checks carried out by the Member State in accordance with national laws, regulations and administrative provisions, Commission officials or servants may carry out on-the-spot checks, including sample checks, on the measures financed by the EGF with a minimum notice of 12 working days. The Commission shall give notice to the Member State concerned with a view to obtaining all the assistance necessary. Officials or servants of the Member State concerned may take part in such checks. 6. The Commission is empowered to adopt delegated acts in accordance with Article 25 in order to supplement point (e) of paragraph 1 of this Article by setting out the criteria for determining the cases of irregularity to be reported and the data to be provided. 7. In order to ensure uniform conditions for the implementation of this Article, the Commission shall adopt an implementing act setting out the format to be used for reporting of irregularities. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 26(2). 8. Member States shall ensure that all supporting documents regarding expenditure incurred are kept available for the Commission and the Court of Auditors for a period of three years following the winding-up of a financial contribution received from the EGF. Article 24 Recovery of the financial contribution 1. Where the actual cost of the coordinated package is less than the amount of the financial contribution pursuant to Article 15, the Commission shall recover the corresponding amount after having given the Member State concerned the possibility to submit its observations. 2. If, after completing the necessary verifications, the Commission concludes that a Member State either has failed to comply with the obligations stated in the decision on a financial contribution or is not complying with its obligations under Article 23(1), it shall give the Member State concerned the possibility to submit its observations. If no agreement has been reached, the Commission shall, within 12 months of receipt of the observations from the Member State, adopt a decision to make the financial corrections required by cancelling all or part of the financial contribution of the EGF to the measure in question. The Member State concerned shall recover any amount unduly paid as a result of an irregularity and, where the amount is not repaid by that Member State in the time allowed, default interest shall be due. Article 25 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 23(6) shall be conferred on the Commission for the duration of the EGF. 3. The delegation of power referred to in Article 23(6) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 23(6) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 26 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 27 Repeal 1. Regulation (EU) No 1309/2013 is repealed with effect from 1 January 2021. 2. Notwithstanding paragraph 1 of this Article, point (b) of Article 20(1) of Regulation (EU) No 1309/2013 shall continue to apply until the ex post evaluation referred to in that point has been carried out. Article 28 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulation (EU) No 1309/2013, which shall continue to apply to those actions until their closure. 2. The financial envelope for the EGF may also cover the technical assistance expenses necessary to ensure the transition between the EGF and the measures adopted pursuant to Regulation (EU) No 1309/2013. 3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the eligible measures provided for in Article 7(1) and (5), to enable the management of actions not completed by 31 December 2027. Article 29 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021, with the exception of Article 15, which shall apply from 3 May 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 28 April 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 110, 22.3.2019, p. 82. (2) OJ C 86, 7.3.2019, p. 239. (3) Position of the European Parliament of 16 January 2019 (not yet published in the Official Journal) and position of the Council at first reading of 19 April 2021 (not yet published in the Official Journal). Position of the European Parliament of 27 April 2021 (not yet published in the Official Journal). (4) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (5) Regulation (EC) No 1927/2006 of the European Parliament and of the Council of 20 December 2006 on establishing the European Globalisation Adjustment Fund (OJ L 406, 30.12.2006, p. 1). (6) Regulation (EC) No 546/2009 of the European Parliament and of the Council of 18 June 2009 amending Regulation (EC) No 1927/2006 on establishing the European Globalisation Adjustment Fund (OJ L 167, 29.6.2009, p. 26). (7) Regulation (EU) No 1309/2013 of the European Parliament and of the Council of 17 December 2013 on the European Globalisation Adjustment Fund (2014-2020) and repealing Regulation (EC) No 1927/2006 (OJ L 347, 20.12.2013, p. 855). (8) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (9) Regulation (EU) 2019/1796 of the European Parliament and of the Council of 24 October 2019 amending Regulation (EU) No 1309/2013 on the European Globalisation Adjustment Fund (2014-2020) (OJ L 279 I, 31.10.2019, p. 4). (10) OJ L 433 I, 22.12.2020, p. 28. (11) OJ L 123, 12.5.2016, p. 1. (12) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (13) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (14) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (15) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (16) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (17) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (18) Council Directive 98/59/EC of 20 July 1998 on the approximation of the laws of the Member States relating to collective redundancies (OJ L 225, 12.8.1998, p. 16). (19) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). ANNEX I COMMUNICATION AND VISIBILITY The licence referred to in the second subparagraph of Article 12(3) shall grant the Union at least the following rights: (1) internal use, namely the right to reproduce, copy and make available the communication and visibility materials to Union and Member State institutions and agencies and their staff; (2) the reproduction of the communication and visibility materials by any means and in any form, in whole or in part; (3) the communication to the public of the communication and visibility materials by any and all means of communication; (4) the distribution to the public of the communication and visibility materials (or copies thereof) in any and all forms; (5) the storage and archiving of the communication and visibility materials; (6) the sublicensing of the rights on the communication and visibility materials to third parties. ANNEX II COMMON OUTPUT AND RESULT INDICATORS FOR EGF APPLICATIONS (referred to in Article 19(1), in point (c) of Article 20(1) and in Article 21(1)) All personal data (1) are to be broken down by gender (female, male, non-binary (2)) (3). (1) Common output indicators on beneficiaries: (a) unemployed*; (b) inactive*; (c) employed*; (d) self-employed*; (e) below 30 years of age*; (f) above 54 years of age*; (g) with lower secondary education or less (ISCED 0-2)*; (h) with upper secondary (ISCED 3) or post-secondary education (ISCED 4)*; (i) with tertiary education (ISCED 5-8)*. The total number of beneficiaries is to be calculated automatically on the basis of the common output indicators relating to employment status (4). (2) Common long-term result indicators for beneficiaries: (a) percentage of EGF beneficiaries in employment and self-employment six months after the end of the implementation period*; (b) percentage of EGF beneficiaries who gained a qualification by six months after the end of the implementation period*; (c) percentage of EGF beneficiaries in education or training six months after the end of the implementation period*. Those data are to cover the calculated total number of beneficiaries as reported under the common output indicators set out in point (1). The percentages shall thus also relate to this calculated total. (1) Managing authorities are to establish a system that records and stores individual participant data in computerised form. The data processing arrangements put in place by the Member States are to be in line with the provisions of Regulation (EU) 2016/679, in particular Articles 4, 6 and 9 thereof. (2) According to national legislation. (3) Data reported under the indicators marked with an asterisk (*) are personal data as defined in point (1) of Article 4 of Regulation (EU) 2016/679. Their processing is necessary for compliance with the legal obligation to which the controller is subject (point (c) of Article 6(1) of Regulation (EU) 2016/679). (4) Unemployed, inactive, employed, self-employed.", "summary": "European Globalisation Adjustment Fund for Displaced Workers (2021-2027) European Globalisation Adjustment Fund for Displaced Workers (2021-2027) SUMMARY OF: Regulation (EU) 2021/691 on the European Globalisation Adjustment Fund for Displaced Workers (EGF) WHAT IS THE AIM OF THE REGULATION? The aim of the regulation is to renew the European Globalisation Adjustment Fund (EGF) for the period covered by the multiannual financial framework (MFF) 2021-2027. Subsequently, the fund has been renamed the European Globalisation Adjustment Fund for Displaced Workers (EGF). It offers support for employees and self-employed persons who have lost their jobs because of major restructuring events. KEY POINTS Mission and objectives The EGF is a solidarity fund financing active labour market measures (such as training, job searches and business start-ups) when there are unexpected and significant job losses arising from major restructuring events. It is an emergency fund outside of the MFF ceilings. Intervention criteria EGF support is triggered if more than 200 (reduced from the previous 500 during the 2014-2020 period) jobs are lost \u2014 salaried or self-employed \u2014 over a 4-month period (for dismissals in the same enterprise, or dismissals in the same region), or over a 6-month period in an enterprise or for a group of businesses (particularly small and medium-sized enterprises) in the same sector and geographical area. For dismissals in an enterprise, this threshold may include suppliers and downstream producers. In small labour markets, applications that do not meet this threshold may be accepted if the redundancies have a serious impact on employment and the local, regional or national economy. Exceptionally, this could also apply to larger labour markets, but the financial help for all such cases in a given year must not exceed 15% of the annual EGF ceiling. The EGF does not apply to workers dismissed as a result of budgetary cuts by an EU Member State (public sector dismissals). Eligible measures A financial contribution from the EGF may be made for active labour market policies forming part of a coordinated package of personalised services, designed to reintegrate the displaced worker into employment or self-employment. This could include the following: training and retraining, including in information and communication technology and other digital skills; certification of acquired knowledge and skills; job-search assistance; targeted group activities; occupational guidance and advisory services; mentoring; outplacement assistance; promoting entrepreneurship; aid for self-employment, business creation, employee takeovers and cooperation activities; time-limited measures (no more than 35% of the total package), such as allowances for mobility, childcare, training, subsistence and carers, along with employers\u2019 recruitment incentives \u2014 on the condition that the beneficiaries actively participate in job-searches or training. The dissemination of skills required in the digital industrial age and in a resource-efficient economy shall be considered as a horizontal element in the design of the coordinated packages. The EGF will not support measures that are the responsibility of enterprises under national law or collective agreements. Member States may apply for aid for preparatory, management, information and publicity, and control and reporting activities. Approved EGF applications are valid for 24 months. Investment in self-employment, business start-ups or employee takeovers may not exceed \u20ac22,000 per beneficiary. The financial contribution from the EGF is limited to what is necessary to provide temporary, one-off support for targeted beneficiaries. Applications Member States must make an EGF application within 12 weeks of the reference period in which the job losses occur, to be analysed by the European Commission, which proposes the mobilisation of the EGF to the budgetary authority (European Parliament and Council). This is necessary as the EGF is outside and above the MFF ceilings. The decision on whether to mobilise EGF funding is taken by the budgetary authority within 6 weeks of receipt of the Commission\u2019s proposal. Co-financing rate The co-financing rate of the EGF is aligned with the highest co-financing rate of the European Social Fund Plus (ESF+) in the Member State concerned, but will not be lower than 60%. Repeal The regulation repeals Regulation (EU) No 1309/2013 with effect from 1 January 2021. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021, with the exception of Article 15 (budgetary procedure and implementation), which has applied since 3 May 2021. BACKGROUND The European Monitoring Centre on Change assists the Commission and the Member States with qualitative and quantitative analyses to help assess trends of globalisation, technological and environmental changes, restructuring and the use of the EGF. The European Pillar of Social Rights, created as a response to social challenges in Europe, acts as a guiding framework for the EGF allowing the EU to put the principles into practice in the case of major restructuring events. The EU Quality Framework for anticipation of change and restructuring is the EU policy instrument that sets the framework for best practice for anticipating and dealing with corporate restructuring. See also: Funding (European Commission)European Globalisation Adjustment Fund for Displaced Workers (EGF) (European Commission). MAIN DOCUMENT Regulation (EU) 2021/691 of the European Parliament and of the Council of 28 April 2021 on the European Globalisation Adjustment Fund for Displaced Workers (EGF) and repealing Regulation (EU) No 1309/2013 (OJ L 153, 3.5.2021, pp. 48-70) RELATED DOCUMENT European Pillar of Social Rights Action Plan, European Commission, 4 March 2021 last update 18.06.2021"}
{"article": "11.6.2021 EN Official Journal of the European Union L 207/1 INTERINSTITUTIONAL AGREEMENT of 20 May 2021 between the European Parliament, the Council of the European Union and the European Commission on a mandatory transparency register THE EUROPEAN PARLIAMENT, THE COUNCIL OF THE EUROPEAN UNION AND THE EUROPEAN COMMISSION Having regard to the Treaty on the Functioning of the European Union, and in particular Article 295 thereof, Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a thereof, Whereas: (1) The European Parliament, the Council of the European Union and the European Commission (\u2018the signatory institutions\u2019) maintain an open, transparent and regular dialogue with representative associations and civil society in accordance with the Treaty on European Union (TEU), and in particular Article 11(1) and (2) thereof. (2) That dialogue enables stakeholders to present their views on decisions that may affect them and hence to contribute effectively to the evidence base on which policy proposals are made. Engaging with stakeholders enhances the quality of decision-making by providing channels for external views and expertise to be given. (3) Transparency and accountability are essential for maintaining the trust of Union citizens in the legitimacy of the political, legislative and administrative processes of the Union. (4) The signatory institutions recognise the importance of coordinating their approach through the adoption of a joint framework for their cooperation, in order to further promote interest representation that is transparent and ethical. (5) Transparency concerning interest representation is especially important in order to allow citizens to follow the activities and be aware of the potential influence of interest representatives, including influence exercised through financial support and sponsorship. Such transparency is best ensured by means of a code of conduct which contains the rules and principles to be observed by interest representatives that sign up to a transparency register (the \u2018register\u2019). (6) In view of the positive experience with the transparency register for organisations and self-employed individuals engaged in EU policy-making and policy implementation established by the agreement between the European Parliament and the European Commission of 16 April 2014 (1) (\u2018the 2014 Agreement\u2019), the signatory institutions consider that the scope of the 2014 Agreement should be expanded. (7) It is necessary to make the register mandatory by putting in place, by means of individual decisions adopted by each of the signatory institutions, measures of equivalent effect that make registration of interest representatives in the register a necessary precondition for carrying out certain types of interest representation activities. (8) In order to further strengthen the joint framework and build on the progress made in establishing a common transparency culture, the signatory institutions should publish on the website of the register conditionality and complementary transparency measures that they put in place to encourage registration, such as dedicated mailing lists, the recommendation that certain decision-makers meet only registered interest representatives, or the publication of information on meetings between certain decision-makers and interest representatives. (9) In order to promote this Agreement beyond the signatory institutions, it should provide for arrangements that allow Union institutions, bodies, offices and agencies, other than the signatory institutions, and Member States\u2019 permanent representations that voluntarily wish to apply the operating principles of the joint framework to benefit from the assistance of the secretariat of the register and its helpdesk support. (10) In order to avoid an unnecessary administrative burden and in line with current practice as regards registration, activities carried out by interest representatives exclusively on behalf of an association or network of which they are part should be considered to be activities of that network or association. (11) Activities of public authorities of Member States, as well as of any association or network of such public authorities that acts on their behalf at Union, national or subnational level, should not be covered by this Agreement, although associations and networks of public authorities at Union, national or subnational level engaging in interest representation activities should be allowed to register. (12) The practice of adopting an annual report on the functioning of the register should be maintained as a tool to ensure appropriate visibility for the coordinated approach of the signatory institutions and to bolster citizens\u2019 trust. The scope of the annual report should be expanded to cover conditionality and complementary transparency measures put in place by the signatory institutions. (13) The functioning of the register should not impinge on the competences of any of the signatory institutions or affect their respective powers of internal organisation. (14) In the exercise of their respective powers of internal organisation, the signatory institutions should delegate to the secretariat and the management board of the register the power to act on their behalf for the adoption of individual decisions concerning applicants and registrants, in accordance with this Agreement. The signatory institutions should be co-defendants in any legal action brought before the Court of Justice of the European Union against final decisions of the management board of the register that adversely affect applicants or registrants. (15) The signatory institutions should act in mutual sincere cooperation in implementing this Agreement. (16) Any of the signatory institutions should be able to pursue other good governance and transparency policies outside the framework of this Agreement, to the extent that such policies do not interfere with the implementation of and the objectives pursued by this Agreement. (17) This Agreement is without prejudice to the exercise of rights under Article 11(4) TEU, concerning the European citizens\u2019 initiative, and Article 227 of the Treaty on the functioning of the European Union (TFEU), concerning the right to petition the European Parliament, AGREE AS FOLLOWS: Article 1 Purpose and scope This Agreement establishes a framework and operating principles for a coordinated approach on the part of the signatory institutions as regards transparent and ethical interest representation. By means of individual decisions taken on the basis of their powers of internal organisation, the signatory institutions agree to implement the coordinated approach referred to in the first paragraph with regard to the activities covered by this Agreement (\u2018covered activities\u2019) and to set out those covered activities that they decide to make conditional upon registration in the register. Article 2 Definitions For the purposes of this Agreement, the following definitions apply: (a) \u2018interest representative\u2019 means any natural or legal person, or formal or informal group, association or network, that engages in covered activities; (b) \u2018applicant\u2019 means any interest representative that applies to be entered in the register; (c) \u2018registrant\u2019 means any interest representative with an entry in the register; (d) \u2018client\u2019 means any interest representative that has entered into a contractual relationship with an intermediary for the purpose of that intermediary advancing that interest representative\u2019s interests by carrying out covered activities; (e) \u2018intermediary\u2019 means any interest representative that advances the interests of a client by carrying out covered activities; (f) \u2018client-intermediary relationship\u2019 means any contractual relationship between a client and an intermediary concerning the carrying out of covered activities; (g) \u2018staff\u2019 means staff subject to the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (2), employed by any of the signatory institutions, irrespective of the category to which they belong; (h) \u2018conditionality\u2019 means the principle whereby registration in the register is a necessary precondition for interest representatives to be able to carry out certain covered activities. Article 3 Covered activities 1. This Agreement shall cover activities carried out by interest representatives with the objective of influencing the formulation or implementation of policy or legislation, or the decision-making processes of the signatory institutions or other Union institutions, bodies, offices and agencies (together referred to as \u2018Union institutions\u2019), without prejudice to Article 4. 2. In particular, covered activities referred to in paragraph 1 include inter alia: (a) organising or participating in meetings, conferences or events, as well as engaging in any similar contacts with Union institutions; (b) contributing to or participating in consultations, hearings or other similar initiatives; (c) organising communication campaigns, platforms, networks and grassroots initiatives; (d) preparing or commissioning policy and position papers, amendments, opinion polls and surveys, open letters and other communication or information material, and commissioning and carrying out research. Article 4 Activities not covered 1. This Agreement shall not cover the following activities: (a) the provision of legal and other professional advice, where: (i) it consists of representing clients in the context of a conciliation or mediation procedure aimed at preventing a dispute from being brought before a judicial or administrative body; (ii) the advice is given to clients to help them ensure that their activities comply with the existing legal framework; or (iii) it consists of representing clients and safeguarding their fundamental or procedural rights, such as the right to be heard, the right to a fair trial, and the right of defence in administrative proceedings, and includes activities carried out by lawyers or by any other professionals involved in representing clients and safeguarding their fundamental or procedural rights; (b) making submissions as a party or a third party in the framework of a legal or administrative procedure established by Union law or by international law applicable to the Union, and submissions based on a contractual relationship with any of the signatory institutions or based on a grant agreement financed by Union funds; (c) activities of the social partners acting as participants in social dialogue pursuant to Article 152 TFEU; (d) making submissions in response to direct and specific requests from any of the Union institutions, their representatives or staff, for factual information, data or expertise; (e) activities carried out by natural persons acting in a strictly personal capacity and not in association with others; (f) spontaneous meetings, meetings of a purely private or social character and meetings taking place in the context of an administrative procedure established by the TEU or TFEU or legal acts of the Union. 2. This Agreement shall not cover activities carried out by the following bodies: (a) public authorities of Member States, including their permanent representations and embassies, at national and subnational level; (b) associations and networks of public authorities at Union, national or subnational level, on condition that they act exclusively on behalf of the relevant public authorities; (c) intergovernmental organisations, including agencies and bodies emanating from them; (d) public authorities of third countries, including their diplomatic missions and embassies, except where such authorities are represented by legal entities, offices or networks without diplomatic status or are represented by an intermediary; (e) political parties, with the exception of any organisations created by or affiliated with political parties; (f) churches and religious associations or communities as well as philosophical and non-confessional organisations referred to in Article 17 TFEU, with the exception of offices, legal entities, or networks created to represent churches, religious communities or philosophical and non-confessional organisations in their relations with the Union institutions, as well as their associations. Article 5 Conditionality and complementary transparency measures 1. The signatory institutions commit to the principle of conditionality, which they shall implement by means of individual decisions on the basis of their powers of internal organisation. 2. When adopting conditionality or complementary transparency measures to encourage registration and strengthen the joint framework established by this Agreement, the signatory institutions shall ensure that such measures are consistent with this Agreement and that they reinforce the objective of the coordinated approach referred to in Article 1, namely, to set a high standard of transparent and ethical interest representation at Union level. 3. Conditionality and complementary transparency measures adopted by the signatory institutions shall be made public on the website of the register, which shall be regularly updated. Article 6 Eligibility and code of conduct 1. Applicants that submit a complete application for registration shall be eligible to be entered in the register if they carry out covered activities and observe the code of conduct set out in Annex I (\u2018code of conduct\u2019). 2. When submitting an application for registration, applicants shall provide the information listed in Annex II and shall agree to that information being made available in the public domain. 3. Applicants may be requested to substantiate their eligibility to be entered in the register and the accuracy of the information submitted by them. 4. The secretariat of the register (\u2018the Secretariat\u2019) shall activate an applicant\u2019s registration once the applicant\u2019s eligibility has been established and the registration is considered to satisfy the requirements set out in Annex II. 5. Once an applicant\u2019s registration has been activated, the applicant shall become a registrant. 6. The Secretariat shall monitor registrations and evaluate registrants\u2019 ongoing eligibility and observance of the code of conduct, in accordance with the procedures set out in Annex III. 7. The Secretariat may carry out investigations on the basis of a complaint alleging that a registrant has not observed the code of conduct, as well as on its own initiative in the light of information that the registrant may no longer satisfy the requirements for eligiblity under paragraph 1. 8. In the context of monitoring or of an investigation by the Secretariat, registrants shall in particular: (a) present, if requested, supporting material demonstrating that the information relating to their registration continues to be accurate; and (b) cooperate sincerely and constructively in accordance with the procedures set out in Annex III. Article 7 Management Board 1. The management board of the register (\u2018Management Board\u2019) shall consist of the Secretaries-General of the signatory institutions, who shall chair it on a rotating basis for a term of one year. 2. The Management Board shall: (a) oversee the overall implementation of this Agreement; (b) determine the annual priorities for the register as well as the budget estimates and share required for the implementation of those priorities; (c) issue general instructions to the Secretariat; (d) adopt the annual report referred to in Article 13; (e) examine and decide upon reasoned requests for review of the Secretariat\u2019s decisions in accordance with point 9 of Annex III. 3. The Management Board shall meet at least annually at the initiative of its Chair. It may also meet upon the request of one of its members. 4. The Management Board shall decide by consensus. Article 8 Secretariat 1. The Secretariat shall be a joint operational structure set up to manage the functioning of the register. It shall be made up of the heads of unit, or equivalent, responsible for transparency issues in each signatory institution (\u2018heads of unit\u2019) and their respective staff. 2. One of the heads of unit shall be designated to act as \u2018Coordinator\u2019 by the Management Board for a renewable term of one year. The Secretariat shall operate under the coordination of the Coordinator. The Coordinator shall represent the Secretariat and oversee its day-to-day work, in the common interest of the signatory institutions. 3. The Secretariat shall: (a) report to the Management Board, prepare its meetings and assist it in its tasks; (b) establish guidelines for registrants, to ensure that this Agreement is applied consistently; (c) decide upon the eligibility of applicants and monitor the content of the register, with the aim of achieving an optimal level of data quality in the register, on the understanding, however, that registrants are ultimately responsible for the accuracy of the information they have provided; (d) provide helpdesk support to applicants and registrants; (e) carry out investigations and apply measures in accordance with Annex III; (f) undertake communication and awareness-raising actions aimed at stakeholders; (g) draft the annual report referred to in Article 13; (h) be responsible for IT development and maintenance of the register; (i) exchange best practice and experience with similar bodies concerning the transparency of interest representation; (j) carry out any other activities necessary for the implementation of this Agreement. 4. The Secretariat shall decide by consensus of the heads of unit. Article 9 Empowerment The Management Board and the Secretariat shall carry out the tasks assigned to them pursuant to Articles 7 and 8 and, in carrying out those tasks, shall be empowered to adopt decisions on behalf of the signatory institutions. Article 10 Resources 1. The signatory institutions shall ensure that the necessary human, administrative, technical and financial resources are made available, including adequate staffing for the Secretariat, so as to ensure that implementation of this Agreement is effective. 2. Without prejudice to point (b) of Article 7(2) and taking into due consideration the different size of the institutions\u2019 establishment plans, the signatory institutions shall take the necessary steps to finance the maintenance, development and promotion of the register. Article 11 Voluntary involvement of Union institutions, bodies, offices and agencies, other than the signatory institutions 1. Union institutions, bodies, offices and agencies, other than the signatory institutions, may notify the Management Board of measures by means of which they decide to make certain activities conditional upon registration in the register, or of any complementary transparency measures that they take. 2. Where the Management Board considers that the measures referred to in paragraph 1 are consistent with the objectives pursued by this Agreement, it may, with the Union institution, body, office or agency concerned, agree conditions under which that institution, body, office or agency may benefit from the Secretariat\u2019s assistance and helpdesk support. Any measures notified under paragraph 1 shall be published on the website of the register. Article 12 Voluntary involvement of Member States\u2019 permanent representations Member States may notify the Management Board of measures taken, in accordance with national law, by means of which they decide to make certain activities targeting their permanent representations conditional upon registration in the register, or of any complementary transparency measures that they take. Any measures so notified shall be published on the website of the register. Article 13 Annual report 1. The Management Board shall adopt an annual report on the functioning of the register during the preceding year. 2. The annual report shall include: (a) a chapter on factual information on the register, its content and any changes concerning the register; (b) a chapter on the conditionality and complementary transparency measures, referred to in Article 5, which are in force. 3. The Management Board shall submit the annual report to the signatory institutions and shall ensure that it is published on the website of the register. Article 14 Review 1. The signatory institutions shall assess the implementation of measures taken pursuant to Article 5 by 2 July 2022, and regularly thereafter, with a view, where appropriate, to making recommendations on the improvement and reinforcement of such measures. 2. This Agreement shall be subject to a review no later than 2 July 2025. Article 15 Final and transitional provisions 1. This Agreement shall be of a binding nature for the signatory institutions. 2. For the purposes of Article 9, each signatory institution commits to adopting a decision which shall read as follows: \u2018The Management Board and the Secretariat shall be empowered to adopt on behalf of the [name of the institution] individual decisions concerning applicants and registrants, in accordance with the Interinstitutional Agreement of 20 May 2021 on a mandatory transparency register (OJ L 207, 11.6.2021, p. 1).\u2019. Those decisions shall enter into force on the date of entry into force of this Agreement. 3. This Agreement shall replace the 2014 Agreement, the effects of which shall cease to apply from the date of entry into force of this Agreement. 4. This Agreement shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 5. Registrants who were entered in the register before the date of entry into force of this Agreement shall, for a period of six months from the date of entry into force of this Agreement, be entitled to amend their registration to satisfy the new requirements resulting from this Agreement in order to remain on the register. 6. Any investigations of alerts or complaints opened under the 2014 Agreement shall be carried out in accordance with the procedure laid down in that Agreement. Done at Brussels, 20 May 2021. For the European Parliament The President David Maria SASSOLI For the Council The President Ana Paula ZACARIAS For the Commission On behalf of the President V\u011bra JOUROV\u00c1 (1) Agreement between the European Parliament and the European Commission on the transparency register for organisations and self-employed individuals engaged in EU policy-making and policy implementation (OJ L 277, 19.9.2014, p. 11.). (2) OJ L 56, 4.3.1968, p. 1. ANNEX I CODE OF CONDUCT Registrants shall operate in line with the rules and principles set out in this Annex. In particular, registrants shall: (a) in their relations with any of the signatory institutions and other Union institutions, bodies, offices or agencies (together referred to as \u2018Union institutions\u2019), always identify themselves by name, by registration number and by the entity or entities they work for or represent; (b) declare the interests and objectives they promote, and specify the clients or members whom they represent as well as, where applicable, the registration number of those clients or members; (c) not obtain or try to obtain information or decisions dishonestly or by use of undue pressure, improper behaviour or offensive language; (d) not abuse their registration for commercial gain or distort or misrepresent the effect of registration; (e) not damage the reputation of the register or cause prejudice to the Union institutions or use their logos without express authorisation; (f) ensure that the information that they provide upon registration, and subsequently administer in the framework of their covered activities, is complete, up-to-date, accurate and not misleading, and agree to that information being made available in the public domain; (g) respect, and avoid obstructing the implementation and application of, the relevant publicly available rules, codes and guidelines established by the Union institutions; (h) not induce Members of the European Parliament, members of the Commission or staff of the Union institutions to contravene the rules and standards of behaviour applicable to them; (i) if employing former Members of the European Parliament, members of the Commission or staff of the Union institutions, take the confidentiality requirements and rules applicable to those individuals after leaving the respective institution duly into account, with a view to preventing conflicts of interest; (j) where engaged in a client-intermediary relationship: (i) ensure that the parties in such a relationship are entered in the register; and (ii) as clients or intermediaries, ensure that the relevant information concerning the relationship entered in the register pursuant to Annex II is published; (k) where, for the purpose of carrying out covered activities, they outsource certain tasks to third parties that are not themselves registered, ensure that such parties adhere to ethical standards that are at least equivalent to those that apply to registrants; (l) present to the Secretariat, if requested, supporting material demonstrating their eligibility and the accuracy of the information submitted, and cooperate sincerely and constructively with the Secretariat; (m) acknowledge that they may be subject to the investigation procedures and, where applicable, measures provided for in Annex III; (n) take appropriate steps to ensure that any of their employees engaged in covered activities are informed about their commitment as registrants to observe this code of conduct; (o) inform the clients or members they represent in the framework of covered activities of their commitment as registrants to observe this code of conduct; (p) respect, and avoid obstructing, the specific access and security rules and arrangements established by the signatory institutions. ANNEX II INFORMATION TO BE ENTERED IN THE REGISTER This Annex sets out the information that shall be available in the register. That information shall be provided by applicants or, as the case may be, registrants, except where it is entered automatically. I. GENERAL INFORMATION (a) name of the entity; address of the head office and the office in charge of relations with the Union, if different from the head office; phone number; e-mail address (1); website; (b) form of the entity; (c) interests represented; (d) confirmation that the applicant operates in accordance with the code of conduct; (e) name of the person legally responsible for the entity and of the person in charge of relations with the Union; (f) an annual estimate of the full-time equivalents for the persons involved in covered activities according to the following percentages of a full-time activity: 10 %, 25 %, 50 %, 75 % or 100 %; (g) goals, remit, fields of interest and geographical level of engagement; (h) organisations of which the registrant is a member and entities with which the registrant is affiliated; (i) registrant\u2019s members and/or affiliation with relevant networks and associations. II. LINKS TO UNION INSTITUTIONS (a) Union legislative proposals, policies or initiatives targeted by the covered activities; (b) membership of Commission expert groups (2) and other Union supported forums and platforms; (c) membership or support of, or participation in, intergroups and other unofficial grouping activities organised on the European Parliament\u2019s premises; (d) names of persons with authorisation to access the European Parliament\u2019s premises (3). III. FINANCIAL INFORMATION Registrants, including intermediaries, shall declare the amount and source of any Union grants contributing to their operating costs. The amounts declared shall be in euros. (a) Registrants promoting their own interests or the collective interests of their members vis-\u00e0-vis any of the signatory institutions shall provide an up-to-date estimate of the annual costs related to covered activities according to the grid below. The estimate of annual costs shall cover a full year of operations and refer to the most recent financial year closed, as of the date of registration or the date of the annual update of the registration details. Bracket size of annual costs, in euros: < 10 000 10 000 \u2013 24 999 25 000 \u2013 49 999 50 000 \u2013 99 999 100 000 \u2013 199 999 200 000 \u2013 299 999 300 000 \u2013 399 999 400 000 \u2013 499 999 500 000 \u2013 599 999 600 000 \u2013 699 999 700 000 \u2013 799 999 800 000 \u2013 899 999 900 000 \u2013 999 999 1 000 000 \u2013 1 249 999 1 250 000 \u2013 1 499 999 1 500 000 \u2013 1 749 999 1 750 000 \u2013 1 999 999 2 000 000 \u2013 2 249 999 2 250 000 \u2013 2 499 999 2 500 000 \u2013 2 749 999 2 750 000 \u2013 2 999 999 3 000 000 \u2013 3 499 999 3 500 000 \u2013 3 999 999 4 000 000 \u2013 4 499 999 4 500 000 \u2013 4 999 999 5 000 000 \u2013 5 499 999 5 500 000 \u2013 5 999 999 6 000 000 \u2013 6 499 999 6 500 000 \u2013 6 999 999 7 000 000 \u2013 7 999 999 8 000 000 \u2013 8 999 999 9 000 000 \u2013 9 999 999 \u2265 10 000 000 Clients shall declare the intermediaries carrying out covered activities on their behalf and the cost for each individual intermediary according to the grid below. The estimate of annual costs shall cover a full year of operations and refer to the most recent financial year closed, as of the date of registration or the date of the annual update of the registration details. Any current intermediaries that are not covered by the most recent financial year closed shall be declared separately by name. Bracket size of representation costs per intermediary, in euros: < 10 000 10 000 \u2013 24 999 25 000 \u2013 49 999 50 000 \u2013 99 999 100 000 \u2013 199 999 200 000 \u2013 299 999 300 000 \u2013 399 999 400 000 \u2013 499 999 500 000 \u2013 599 999 600 000 \u2013 699 999 700 000 \u2013 799 999 800 000 \u2013 899 999 900 000 \u2013 999 999 \u2265 1 000 000 (b) Intermediaries shall declare the estimated total annual revenue generated that is attributable to covered activities according to the grid below. The estimated total annual revenue generated shall cover a full year of operations and refer to the most recent financial year closed, as of the date of registration or the date of the annual update of the registration details. Revenue from individual clients for covered activities shall also be listed according to the grid below, accompanied by an indication of the Union legislative proposals, policies or initiatives targeted by the covered activities: Bracket size of revenue generated per client, in euros: < 10 000 10 000 \u2013 24 999 25 000 \u2013 49 999 50 000 \u2013 99 999 100 000 \u2013 199 999 200 000 \u2013 299 999 300 000 \u2013 399 999 400 000 \u2013 499 999 500 000 \u2013 599 999 600 000 \u2013 699 999 700 000 \u2013 799 999 800 000 \u2013 899 999 900 000 \u2013 999 999 \u22651 000 000 The estimated total annual revenue generated for covered activities shall be calculated automatically by the register based on the aggregate of the estimated revenue generated per client. Intermediaries shall declare on the register the clients on behalf of whom covered activities are carried out. Any current clients that are not covered by the most recent financial year closed shall be declared on the register separately by name. (c) Registrants that do not represent commercial interests shall provide the following financial information: (i) their total budget for the most recent financial year closed; (ii) their main sources of funding by category: Union funding, public financing, grants, donations, their members\u2019 contributions etc.; (iii) the amount of each contribution they received exceeding 10 % of their total budget, if the contributions are above EUR 10 000, and the name of the contributor. (1) Email address provided will not be published. (2) Membership of expert groups shall be inserted in the register automatically. Registration shall not confer an automatic entitlement to such membership. (3) Registrants can request authorisation for access to the European Parliament\u2019s premises at the end of the registration process. The names of individuals who receive access passes to the European Parliament\u2019s premises shall be automatically inserted in the register. Registration shall not confer an automatic entitlement to such an access pass. ANNEX III MONITORING, INVESTIGATIONS AND MEASURES 1. General principles 1.1. The Secretariat may open an investigation on the basis of a complaint alleging that a registrant has not observed the code of conduct (\u2018non-observance\u2019) as well as on its own initiative in the light of information that the registrant may be ineligible. 1.2. An investigation is an administrative procedure involving the Secretariat and the registrant concerned, as well as, where the investigation was not opened on the Secretariat\u2019s own initiative, the third party that lodged the complaint (\u2018complainant\u2019). 1.3. When an investigation has been opened, the Secretariat may suspend the registration concerned as a precaution. The Secretariat shall immediately inform the registrant concerned of its decision to suspend the registration, providing a reasoned explanation for its decision. 2. Admissibility of complaints 2.1. Any natural or legal person may lodge a complaint with the Secretariat concerning a registrant\u2019s alleged non-observance. Complaints shall be submitted in writing. In order to be admissible, the complaint shall: (a) identify the registrant concerned and clearly set out the details of the complaint; (b) provide the name and contact details of the complainant; (c) be lodged within one year of the alleged non-observance; (d) be supported by evidence demonstrating a reasonable probability of non-observance. 2.2. Where a complaint is inadmissible, the Secretariat shall notify the complainant accordingly, providing a reasoned explanation for its decision. 3. Complaints procedure 3.1. Following receipt of an admissible complaint, the Secretariat shall open an investigation and notify the complainant and the registrant concerned. 3.2. The registrant concerned shall receive a copy of the complaint, including any annexes, and be asked to provide a reasoned response within 20 working days. 3.3. The Secretariat shall take into account any reasoned response received under point 3.2, gather any relevant information, and draft a report on its findings. 3.4. Where the report finds that the registrant concerned has not observed the code of conduct, the Secretariat shall notify the registrant accordingly. That notification may also contain: (a) instructions to remedy the non-observance within 20 working days of receipt of the notification; and (b) a formal warning that measures may be taken if the non-observance is not remedied or recurs. 3.5. The Secretariat shall declare the registrant concerned eligible to remain on the register and close the investigation, where one of the following applies: (a) the alleged non-observance primarily concerns point (f) of the code of conduct and is remedied within 20 working days of receipt of the notification under point 3.1; (b) the report finds that the registrant has observed the code of conduct; (c) the registrant remedies the non-observance after being notified under point (a) of point 3.4; (d) a formal warning under point (b) of point 3.4 is deemed sufficient. 3.6. The Secretariat shall declare the registrant concerned ineligible and close the investigation, where the report finds that the registrant has not observed the code of conduct and one of the following applies: (a) the registrant has not remedied the non-observance after being notified under point (a) of point 3.4; (b) a formal warning under point (b) of point 3.4 is deemed insufficient. 3.7. Once the Secretariat has drafted its report, it shall provide the registrant concerned with a copy of that report upon request. 4. Monitoring and own-initiative investigations 4.1. The Secretariat may request that registrants amend their registrations where it has reason to believe that those registrations do not accurately provide the information specified in Annex II. 4.2. Where a request under point 4.1 is made, the Secretariat may suspend the registration concerned as a precaution. 4.3. Where the registrant concerned does not cooperate sincerely and constructively, the Secretariat may remove from the register a registration that is subject to a request under point 4.1. 4.4. The Secretariat may open an investigation on its own initiative in the light of information that a registrant may be ineligible. 4.5. Where the Secretariat opens an investigation on its own initiative, it shall notify the registrant concerned and ask the registrant to provide a reasoned response within 20 working days. 4.6. The Secretariat shall take into account any reasoned response received under point 4.5, gather any relevant information, and draft a report on its findings. 4.7. Where the report finds that the registrant concerned is ineligible, the Secretariat shall notify the registrant accordingly. That notification may also contain: (a) instructions to remedy the ineligibility within 20 working days of receipt of the notification; and (b) a formal warning that measures may be imposed if the ineligibility is not remedied or recurs. 4.8. The Secretariat shall declare the registrant concerned eligible and close the investigation, where one of the following applies: (a) the investigation primarily concerns a suspected absence of covered activities and the registrant concerned demonstrates, within 20 working days of receipt of the notification under point 4.5, that they carry out covered activities; (b) the report finds that the registrant is eligible; (c) the registrant remedies the ineligibility after being notified under point (a) of point 4.7; (d) a formal warning under point (b) of point 4.7 is deemed sufficient. 4.9. The Secretariat shall declare the registrant concerned ineligible and close the investigation where the investigation primarily concerns a suspected absence of covered activities and the registrant concerned does not demonstrate, within 20 working days of receipt of the notification under point 4.5, that they carry out covered activities. 4.10. The Secretariat shall declare the registrant concerned ineligible and close the investigation where the report referred to in point 4.6 finds that the registrant is ineligible and one of the following applies: (a) the registrant does not remedy the ineligibility after being notified under point (a) of point 4.7; (b) a formal warning under point (b) of point 4.7 is deemed insufficient. 4.11. Once the Secretariat has drafted its report, it shall provide the registrants concerned with a copy of that report upon request. 5. Cooperation with the Secretariat during investigations 5.1. The Secretariat shall, where necessary, request the parties to an investigation to provide information relevant to the investigation within 20 working days of the request. The parties concerned may indicate which information provided by them should be considered sensitive. 5.2. The Secretariat may decide to hear the parties to an investigation. 5.3. The Secretariat may decide to extend the deadlines set in accordance with this Annex, where requested by registrants and justified by reasonable grounds. That decision may also involve suspending the registration concerned for the duration of the investigation. 5.4. If the Secretariat considers that a registrant concerned by an investigation is not cooperating sincerely and constructively in the investigation, it may, after having given the registrant the possibility to make their views known in writing, close the investigation and remove the registration concerned from the register. 6. Right to be heard The registrant shall have the possibility to make known their own views in writing before any decision establishing ineligibility is taken. 7. Decision 7.1. The Secretariat shall close an investigation with a reasoned decision. The Secretariat shall notify the parties concerned in writing of that decision. That decision shall specify whether ineligibility was established. Where applicable, the decision shall also specify the form of ineligibility and what measure was taken by the Secretariat as well as the relevant remedies. 7.2. Where the Secretariat establishes that a registrant is ineligible in accordance with point 7.1, it shall remove the registration concerned from the register. 7.3. The Secretariat may consider a request to reopen an investigation up to 20 working days after the parties concerned have been informed of its decision. 7.4. An investigation may only be reopened where information that was available before the Secretariat made its decision was, through no fault or oversight of the party making the request under point 7.3, not considered by the Secretariat when it made its decision. 8. Measures 8.1. Where the Secretariat removes a registration under point 7.2 due to it having established that the ineligibility relates to non-observance, it may also, where appropriate in the light of the seriousness of the non-observance: (a) prohibit the interest representative concerned from registering again for a period of between 20 working days and two years; and (b) publish the measure taken on the website of the register. 8.2. When deciding on the severity of the measure taken pursuant to point 8.1, the Secretariat shall duly take into account the relevant circumstances of an investigation, in the light of the objectives pursued by this Agreement. 8.3. Interest representatives subject to a prohibition under point (a) of point 8.1 may not register again until the period of removal has expired and the registrant has satisfactorily remedied the grounds that led to the removal. 9. Review 9.1. Registrants that are subject to measures taken under point 8.1 may lodge a reasoned request for review by the Management Board. 9.2. The request for review shall be sent to the Secretariat within 20 working days of receipt of the notification of the measure taken by the Secretariat. 9.3. Requests for review submitted in accordance with points 9.1 and 9.2 shall be forwarded to the Chair of the Management Board, who may refer the case to the full Management Board where appropriate or where requested by one of the other members of the Management Board. 9.4. A request for review shall not suspend the measure taken by the Secretariat, unless the Management Board decides otherwise on the basis of specific grounds set out in the request for review. 9.5. The Chair of the Management Board shall notify the registrants concerned of the Management Board\u2019s decision on the review within 40 working days of receipt of the request for review. 10. Remedies Registrants that are not satisfied with a decision of the Management Board under point 9 may appeal to the Court of Justice of the European Union in accordance with Article 263 TFEU or submit a complaint to the European Ombudsman in accordance with Article 228 TFEU.", "summary": "Lobbying regulation \u2014 the EU mandatory transparency register Lobbying regulation \u2014 the EU mandatory transparency register SUMMARY OF: Interinstitutional Agreement on a mandatory transparency register WHAT IS THE AIM OF THE AGREEMENT? The agreement aims to reinforce a common transparency culture and set high standards of transparent and ethical interest representation at the European Union (EU) level by establishing: a joint framework for cooperation between the European Parliament, the Council and the European Commission (\u2018the signatory institutions\u2019) regarding their dealings with interest representatives*; a transparency register (\u2018the register\u2019), in which interest representatives must register in order to be able to carry out certain interest representation activities (principle of conditionality); a code of conduct that interest representatives must observe and information requirements that they must comply with in order to be eligible for registration; a procedure for monitoring the application of the code of conduct, investigating alleged violations of that code and taking action in the event of non-observance. KEY POINTS The agreement: applies to various activities (\u2018covered activities\u2019) carried out by interest representatives to influence the formulation or implementation of EU policy or legislation, or the decision-making processes of the signatory institutions or other EU institutions, bodies, offices and agencies; identifies covered activities including: organising or participating in meetings, conferences and events, and engaging in any similar contacts with EU institutions,contributing to, or participating in, consultations, hearings or similar initiatives,organising communication campaigns, platforms, networks and grassroots initiatives,preparing or commissioning policy and position papers, amendments, opinion polls, surveys, open letters, other communication or information material, or commissioning and carrying out research; exempts a range of activities, such as: the provision of legal and other professional advice to clients in specific circumstances,activities by employers and trade unions acting as participants in social dialogue,activities carried out by individuals acting in a strictly personal capacity and not in association with others,spontaneous, purely private or social meetings and meetings taking place in the context of an administrative procedure established by the treaties or legal acts of the EU; does not apply to the activities of the following bodies: EU Member State public authorities, including their national and subnational embassies and permanent representations,intergovernmental organisations and their agencies and bodies; does not apply either, subject to some exceptions, to activities of the following bodies: EU, national or subnational associations and networks of public authorities,public authorities, including diplomatic missions and embassies, of non-EU countries,political parties,churches and religious associations or communities, and philosophical and non-confessional organisations. The signatory institutions agree to apply the principle of conditionality, whereby registration in the register is a necessary precondition for interest representatives to be able to carry out certain covered activities. To that end, they adopt conditionality measures by means of individual decisions on the basis of their powers of internal organisation. The signatory institutions may further adopt complementary transparency measures to encourage registration and strengthen the joint framework. Interest representatives that apply to be entered in the register must: provide a wide range of information listed in Annex II to the agreement and agree to make that information publicly available, notably: their name, contact details, staff numbers, legal representative and interests represented, along with the organisations or entities of which the registrant is a member and the registrant\u2019s members,the EU legislative proposals, policies or initiatives they target, membership of Commission expert groups and other EU-supported forums and platforms or of intergroups or other unofficial groupings of Members of the European Parliament (MEPs),financial information, including, within specific bands, annual costs of their activities, costs for intermediaries carrying out activities on their behalf, revenue from individual clients (for intermediaries) or total budget and sources of funding (for registrants that do not represent commercial interests); observe the code of conduct set out in Annex I to the agreement, with its 16 rules and principles, which requires that registrants: declare the interests and objectives they promote and specify the clients or members whom they represent,not obtain or try to obtain information dishonestly or persuade MEPs, members of the Commission or EU staff to break the rules and standards of behaviour applicable to them,not abuse their registration for commercial gain,ensure the information they provide for registration purposes is complete, up to date and accurate. The agreement establishes: a management board of the register \u2014 consisting of the secretaries-general of the signatory institutions \u2014 to: determine the register\u2019s priorities and the budget and share required for the implementation of those priorities,adopt an annual report and oversee the overall implementation of the agreement; a secretariat of the register \u2014 consisting of the heads of unit responsible for transparency issues in the signatory institutions and their staff \u2014 to manage the register, which involves: establishing guidelines for registrants and providing help-desk support to applicants and registrants,deciding upon the eligibility of applicants and monitoring the content of the register,carrying out investigations and applying measures in accordance with the procedure in Annex III to the agreement. The management board and the secretariat of the register are empowered to adopt, on behalf of the signatory institutions, individual decisions concerning applicants and registrants. The signatory institutions ensure the secretariat of the register has the necessary human, administrative, technical and financial resources. Other EU institutions, bodies, offices and agencies and Member States (for their permanent representations) may notify the management board of the register of measures they take to make certain activities conditional upon registration in the register or of any complementary transparency measures they take on a voluntary basis. Conditionality and complementary transparency measures adopted by the signatory institutions and other EU institutions, bodies, offices or agencies or Member States (for their permanent representations) are made public on the website of the register. The agreement replaces its 2014 predecessor and will be reviewed no later than 2 July 2025. FROM WHEN DOES THE AGREEMENT ENTER INTO FORCE? It has been in force since 1 July 2021. BACKGROUND The agreement is complemented by a political statement of the European Parliament, the Council and the Commission: recognising the importance of the principle of conditionality and emphasising the aim of the three institutions\u2019 coordinated approach, namely to reinforce a common transparency culture, while setting high standards of transparent and ethical interest representation at the EU level;listing the conditionality and complementary transparency measures already in place for each of the signatory institutions that are acknowledged to be consistent with the agreement. In addition, the Council adopted a decision on 6 May 2021 establishing the rules for contact between its general secretariat and interest representatives. The agreement replaces a 2014 agreement between the European Parliament and the Commission (the Council was an observer) on a transparency register for organisations and self-employed individuals engaged in EU policymaking and policy implementation. It expands the scope of the previous register and makes the registration of interest representatives in the transparency register a prerequisite for certain interest representation activities, such as meeting certain decision-makers or staff of the signatory institutions or getting access to the institutions\u2019 premises. For further information, see: Transparency register (European Commission). KEY TERMS Interest representative. Any natural or legal person, formal or informal group, association or network engaged in lobbying (described as \u2018covered activities\u2019 in the agreement). MAIN DOCUMENT Interinstitutional Agreement of 20 May 2021 between the European Parliament, the Council of the European Union and the European Commission on a mandatory transparency register (OJ L 207, 11.6.2021, pp. 1\u201317). RELATED DOCUMENTS Political statement of the European Parliament, the Council of the European Union and the European Commission on the occasion of the adoption of the Interinstitutional Agreement on a Mandatory Transparency Register (OJ L 207, 11.6.2021, p. 18). Council Decision (EU) 2021/929 of 6 May 2021 on the regulation of contacts between the General Secretariat of the Council and interest representatives (OJ L 207, 11.6.2021, pp. 19\u201321). last update 29.09.2021"}
{"article": "22.12.2020 EN Official Journal of the European Union LI 433/28 INTERINSTITUTIONAL AGREEMENT BETWEEN THE EUROPEAN PARLIAMENT, THE COUNCIL OF THE EUROPEAN UNION AND THE EUROPEAN COMMISSION ON BUDGETARY DISCIPLINE, ON COOPERATION IN BUDGETARY MATTERS AND ON SOUND FINANCIAL MANAGEMENT, AS WELL AS ON NEW OWN RESOURCES, INCLUDING A ROADMAP TOWARDS THE INTRODUCTION OF NEW OWN RESOURCES INTERINSTITUTIONAL AGREEMENT of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources THE EUROPEAN PARLIAMENT, THE COUNCIL OF THE EUROPEAN UNION AND THE EUROPEAN COMMISSION, hereinafter referred to as the \"Institutions\", Having regard to the Treaty on the Functioning of the European Union, and in particular Article 295 thereof, HAVE AGREED AS FOLLOWS: 1. The purpose of this Agreement is to implement budgetary discipline, to improve the functioning of the annual budgetary procedure and cooperation between the Institutions on budgetary matters as well as to ensure sound financial management, and to implement a cooperation and establish a roadmap towards the introduction, over the period of the multiannual financial framework 2021-2027 (\"MFF 2021-2027\"), of new own resources that are sufficient to cover the repayment of the European Union Recovery Instrument established under Council Regulation (EU) 2020/2094 (1) (the \"EURI Regulation\"). 2. Budgetary discipline as referred to in this Agreement covers all expenditure. This Agreement is binding on the Institutions for as long as it is in force. The Annexes to this Agreement form an integral part thereof. 3. This Agreement does not alter the respective budgetary and legislative powers of the Institutions as laid down in the Treaties, in Council Regulation (EU, Euratom) 2020/2093 (2) (the \"MFF Regulation\"), in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (3) (the \"Financial Regulation\") and in Council Decision (EU, Euratom) 2020/2053 (4) (the \"Own Resources Decision\"), and is without prejudice to the powers of national parliaments in respect of own resources. 4. Any amendment of this Agreement requires the common agreement of the Institutions. 5. This Agreement is in four parts: \u2014 Part I contains provisions related to the multiannual financial framework (MFF) and to the thematic and non-thematic special instruments; \u2014 Part II relates to interinstitutional cooperation in budgetary matters; \u2014 Part III contains provisions related to the sound financial management of Union funds; \u2014 Part IV contains provisions related to the quality and comparability of data on beneficiaries in the context of the protection of the Union budget. 6. This Agreement enters into force on 16 December 2020 and replaces the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (5). PART I MFF AND SPECIAL INSTRUMENTS A. PROVISIONS RELATED TO THE MFF 7. The Institutions shall, for the purposes of sound financial management, ensure as far as possible during the budgetary procedure and at the time the general budget of the Union is adopted that sufficient margins are left available beneath the ceilings for the various headings of the MFF, except for the sub-heading \"Economic, social and territorial cohesion\". Updating of forecasts for payment appropriations 8. Every year, the Commission shall update the forecasts for payment appropriations for the period at least until 2027. That update shall take into account all relevant information, including the real implementation of budget appropriations for commitments and budget appropriations for payments, as well as the implementation forecasts. It shall also consider the rules designed to ensure that payment appropriations develop in an orderly manner compared to commitment appropriations and to the growth forecasts of the Union's gross national income (GNI). B. PROVISIONS RELATED TO THE THEMATIC AND NON-THEMATIC SPECIAL INSTRUMENTS European Globalisation Adjustment Fund 9. Where the conditions for mobilising the European Globalisation Adjustment Fund set out in the relevant basic act are met, the Commission shall submit a proposal to mobilise it, and the decision to mobilise the European Globalisation Adjustment Fund shall be taken jointly by the European Parliament and by the Council. At the same time as it presents its proposal for a decision to mobilise the European Globalisation Adjustment Fund, the Commission shall present a proposal to the European Parliament and to the Council for a transfer to the relevant budget lines. Transfers related to the European Globalisation Adjustment Fund shall be made in accordance with the Financial Regulation. Solidarity and Emergency Aid Reserve 10. Where the Commission considers that the conditions for mobilising the Solidarity and Emergency Aid Reserve are met, it shall submit a proposal to the European Parliament and to the Council for a transfer from that Reserve to the corresponding budget lines in accordance with the Financial Regulation. The decision to mobilise amounts under point (a) of Article 9(1) of the MFF Regulation shall be taken jointly by the European Parliament and by the Council on a proposal from the Commission in accordance with the relevant basic act. Before making any proposal for a transfer from the Solidarity and Emergency Aid Reserve for assistance under point (b) of Article 9(1) of the MFF Regulation, the Commission shall examine the scope for reallocating appropriations. Brexit Adjustment Reserve 11. Where the conditions for mobilising the Brexit Adjustment Reserve set out in the relevant instrument are met, the Commission shall submit a proposal to the European Parliament and to the Council for a transfer to the relevant budget lines. Transfers related to the Brexit Adjustment Reserve shall be made in accordance with the Financial Regulation. Single Margin Instrument 12. The Commission may propose to mobilise the amounts corresponding to all or a part of the margins referred to in points (a) and (c) of the first subparagraph of Article 11(1) of the MFF Regulation, in relation to a draft budget or a draft amending budget. The mobilisation of any amounts referred to in point (c) of the first subparagraph of Article 11(1) of that Regulation shall be proposed by the Commission after a thorough analysis of all other financial possibilities. Those amounts may be mobilised by the European Parliament and by the Council in the framework of the budgetary procedure set out in Article 314 of the Treaty on the Functioning of the European Union (TFEU). Flexibility Instrument 13. The Commission shall submit a proposal for the mobilisation of the Flexibility Instrument after it has examined all possibilities for reallocating appropriations under the heading requiring additional expenditure. That proposal shall identify the needs to be covered and the amount. Such a proposal may be made in relation to a draft budget or a draft amending budget. The Flexibility Instrument may be mobilised by the European Parliament and by the Council in the framework of the budgetary procedure set out in Article 314 TFEU. PART II IMPROVEMENT OF INTERINSTITUTIONAL COOPERATION IN BUDGETARY MATTERS A. INTERINSTITUTIONAL COOPERATION PROCEDURE 14. The details of interinstitutional cooperation during the budgetary procedure are set out in Annex I. 15. In line with Article 312(5) TFEU, the Institutions shall take any measure necessary to facilitate the adoption of a new MFF or a revision thereof, in accordance with the special legislative procedure referred to in Article 312(2) of the TFEU. Such measures will include regular meetings and exchange of information between the European Parliament and the Council and, on the initiative of the Commission, meetings of the Presidents of the Institutions as set out in Article 324 TFEU in order to promote consultation and the reconciliation of the positions of the Institutions. Where a proposal for a new MFF or for a substantial revision has been presented, the Institutions will seek to determine specific arrangements for cooperation and dialogue between them throughout the procedure leading to its adoption. Budgetary transparency 16. The Commission shall prepare an annual report to accompany the general budget of the Union, bringing together available non-confidential information relating to: (a) the assets and liabilities of the Union, including those arising from borrowing and lending operations carried out by the Union in accordance with its powers under the Treaties; (b) the revenue, expenditure, assets and liabilities of the European Development Fund (6), the European Financial Stability Facility, the European Stability Mechanism, and other possible future mechanisms; (c) the expenditure incurred by Member States in the framework of enhanced cooperation, to the extent that it is not included in the general budget of the Union; (d) climate expenditure, on the basis of an effective methodology set out by the Commission and, where relevant, in accordance with sectoral legislation, for monitoring climate spending and its performance with a view to achieving an overall target of at least 30 % of the total amount of the Union budget and the European Union Recovery Instrument expenditures supporting climate objectives, taking into consideration the effects of the phasing out of the funding under the European Union Recovery Instrument and differentiating between climate change mitigation and adaptation, where feasible. Where there is insufficient progress towards the climate spending target in one or more of the relevant programmes, the Institutions, in accordance with their responsibilities and the relevant legislation, will consult each other on appropriate measures to be taken to ensure that Union spending on climate objectives over the entire MFF 2021-2027 corresponds to at least 30 % of the total amount of the Union budget and the European Union Recovery Instrument expenditures; (e) expenditure contributing to halting and reversing the decline of biodiversity, on the basis of an effective, transparent and comprehensive methodology set out by the Commission, in cooperation with the European Parliament and with the Council, and, where relevant, in accordance with sectoral legislation, with a view to working towards the ambition of providing 7,5 % in 2024 and 10 % in 2026 and in 2027 of annual spending under the MFF to biodiversity objectives, while considering the existing overlaps between climate and biodiversity goals; (f) the promotion of equality between women and men as well as rights and equal opportunities for all throughout the implementation and monitoring of the relevant programmes, and the mainstreaming of those objectives as well as gender mainstreaming, including by strengthening the assessment of gender impact in impact assessments and evaluations under the Better Law-Making framework. The Commission will examine how to develop a methodology to measure the relevant expenditure at programme level in the MFF 2021-2027. The Commission will use that methodology as soon as it is available. No later than 1 January 2023, the Commission will implement that methodology for certain centrally managed programmes to test its feasibility. At mid-term, it will be explored whether the methodology can be extended to other programmes for the remainder of the MFF 2021-2027; (g) the implementation of the United Nations Sustainable Development Goals in all relevant Union programmes of the MFF 2021-2027. The effective methodologies referred to in points (d) and (e) of the first paragraph will, as far as possible include a reference to the contribution of the Union budget to the European Green Deal, which includes the \"do no harm\" principle. The effective methodology referred to in point (d) of the first paragraph will be transparent, comprehensive, result-oriented and performance-based, will include annual consultation by the Commission of the European Parliament and of the Council, and will identify relevant measures to be taken in case of insufficient progress towards achieving applicable targets. None of the methodologies referred to in this point should lead to an excessive administrative burden on project holders or on beneficiaries. 17. The Commission shall prepare an annual report on the implementation of the European Union Recovery Instrument. That annual report shall bring together available non-confidential information relating to: \u2014 assets and liabilities arising from borrowing and lending operations carried out under Article 5 of the Own Resources Decision; \u2014 the aggregate amount of proceeds assigned to Union programmes in implementation of the European Union Recovery Instrument in the previous year, broken down by programme and budget line; \u2014 the contribution of the borrowed funds to the achievements of the objectives of the European Union Recovery Instrument and the specific Union programmes. B. INCORPORATION OF FINANCIAL PROVISIONS IN LEGISLATIVE ACTS 18. Each legislative act, concerning a multiannual programme, adopted in accordance with the ordinary legislative procedure shall contain a provision in which the legislator lays down the financial envelope for the programme. That amount shall constitute the prime reference amount for the European Parliament and for the Council during the annual budgetary procedure. For programmes referred to in Annex II to the MFF Regulation, the prime reference amount is automatically increased by the additional allocations referred to in Article 5(1) of the MFF Regulation. The European Parliament and the Council, and the Commission when it draws up the draft budget, undertake not to depart by more than 15 % from that amount for the entire duration of the programme concerned, unless new, objective, long-term circumstances arise for which explicit and precise reasons are given, with account being taken of the results obtained from implementing the programme, in particular on the basis of assessments. Any increase resulting from such variation shall remain beneath the existing ceiling for the heading concerned, without prejudice to the use of instruments referred to in the MFF Regulation and in this Agreement. The fourth paragraph does not apply to the additional allocations referred to in the third paragraph. This point does not apply to appropriations for cohesion adopted in accordance with the ordinary legislative procedure and pre-allocated per Member State which contain a financial envelope for the entire duration of the programme or to the large-scale projects referred to in Article 18 of the MFF Regulation. 19. Legally binding Union acts concerning multiannual programmes that are not adopted in accordance with the ordinary legislative procedure shall not contain an \"amount deemed necessary\". Should the Council wish to include a financial reference amount, that amount shall be taken as illustrating the will of the legislator and shall not affect the budgetary powers of the European Parliament and of the Council as set out in the TFEU. A provision to that effect shall be included in all legally binding Union acts which contain such a financial reference amount. C. EXPENDITURE RELATING TO FISHERIES AGREEMENTS 20. Expenditure on fisheries agreements shall be subject to the following specific rules. The Commission undertakes to keep the European Parliament regularly informed about the preparation and conduct of the negotiations on fisheries agreements, including the budgetary implications of those agreements. In the course of the legislative procedure relating to fisheries agreements, the Institutions undertake to make every effort to ensure that all procedures are carried out as quickly as possible. Amounts provided for in the budget for new fisheries agreements or for the renewal of fisheries agreements which enter into force after 1 January of the financial year concerned shall be put in reserve. If appropriations relating to fisheries agreements, including the reserve, prove insufficient, the Commission shall provide the European Parliament and the Council with the necessary information on the causes of the situation and on measures which might be adopted under established procedures. Where necessary, the Commission shall propose appropriate measures. Each quarter, the Commission shall present to the European Parliament and to the Council detailed information about the implementation of fisheries agreements in force and a financial forecast for the remainder of the year. 21. Without prejudice to the relevant procedure governing the negotiation of fisheries agreements, the European Parliament and the Council commit themselves, in the framework of budgetary cooperation, to arrive at a timely agreement on the adequate financing of fisheries agreements. D. FINANCING OF THE COMMON FOREIGN AND SECURITY POLICY (CFSP) 22. The total amount of CFSP operating expenditure shall be entered entirely in one budget chapter, entitled CFSP. That amount shall cover the real predictable needs, assessed in the framework of the establishment of the draft budget, on the basis of forecasts drawn up annually by the High Representative of the Union for Foreign Affairs and Security Policy (the \"High Representative\"). A reasonable margin shall be allowed to cover unforeseen actions. No funds may be entered in a reserve. 23. As regards CFSP expenditure which is charged to the Union budget in accordance with Article 41 of the Treaty on European Union, the Institutions shall endeavour, in the Conciliation Committee as referred to in Article 314(5) TFEU, and on the basis of the draft budget established by the Commission, to secure agreement each year on the amount of the operating expenditure, and on the distribution of that amount between the articles of the CFSP budget chapter. In the absence of agreement, it is understood that the European Parliament and the Council shall enter in the budget the amount contained in the previous budget or the amount proposed in the draft budget, whichever is the lower. The total amount of CFSP operating expenditure shall be distributed between the articles of the CFSP budget chapter as suggested in the third paragraph. Each article shall cover actions already adopted, actions which are foreseen but not yet adopted and amounts for future \u2013 that is unforeseen \u2013 actions to be adopted by the Council during the financial year concerned. Within the CFSP budget chapter, the articles into which the CFSP actions are to be entered could read along the following lines: \u2014 single major missions as referred to in point (g) of Article 52(1) of the Financial Regulation; \u2014 other missions (for crisis management operations, conflict prevention, resolution and stabilisation, and monitoring and implementation of peace and security processes); \u2014 non-proliferation and disarmament; \u2014 emergency measures; \u2014 preparatory and follow-up measures; \u2014 European Union Special Representatives. Since, under the Financial Regulation, the Commission has the authority to transfer appropriations autonomously between articles within the CFSP budget chapter, the flexibility deemed necessary for speedy implementation of CFSP actions shall accordingly be assured. In the event of the amount of the CFSP budget chapter during the financial year being insufficient to cover the necessary expenses, the European Parliament and the Council shall seek a solution as a matter of urgency, on a proposal from the Commission. 24. Each year, the High Representative shall consult the European Parliament on a forward-looking document, which shall be transmitted by 15 June of the year in question, setting out the main aspects and basic choices of the CFSP, including the financial implications for the Union budget, an evaluation of the measures launched in year n-1 and an assessment of the coordination and complementarity of CFSP with the Union's other external financial instruments. Furthermore, the High Representative shall keep the European Parliament regularly informed by holding joint consultation meetings at least five times a year, in the framework of the regular political dialogue on the CFSP, to be agreed at the latest on 30 November each year. Participation in those meetings shall be determined by the European Parliament and by the Council respectively, bearing in mind the objective, and the nature of the information exchanged in those meetings. The Commission shall be invited to participate in those meetings. If the Council adopts a decision in the field of the CFSP entailing expenditure, the High Representative shall immediately, and in any event no later than five working days thereafter, send the European Parliament an estimate of the costs envisaged (a \"financial statement\"), in particular those costs regarding time-frame, staff employed, use of premises and other infrastructure, transport facilities, training requirements and security arrangements. Once a quarter, the Commission shall inform the European Parliament and the Council about the implementation of CFSP actions and the financial forecasts for the remainder of the financial year. E. INVOLVEMENT OF THE INSTITUTIONS AS REGARDS DEVELOPMENT POLICY ISSUES 25. The Commission shall establish an informal dialogue with the European Parliament on development policy issues. PART III SOUND FINANCIAL MANAGEMENT OF UNION FUNDS A. FINANCIAL PROGRAMMING 26. The Commission shall submit twice a year, the first time together with the documents accompanying the draft budget and the second time after the adoption of the general budget of the Union, a complete financial programming for headings 1, 2 (except for the sub-heading \"Economic, social and territorial cohesion\"), 3 (for \"Environment and climate action\" and \"Maritime policy and fisheries\"), 4, 5 and 6 of the MFF. That programming, structured by heading, policy area and budget line, should identify: (a) the legislation in force, with a distinction being drawn between multiannual programmes and annual actions: (i) for multiannual programmes, the Commission should indicate the procedure under which they were adopted (ordinary or special legislative procedure), their duration, the total financial envelope and the share allocated to administrative expenditure; (ii) for multiannual programmes referred to in Annex II to the MFF Regulation, the Commission should indicate transparently the additional allocations under Article 5 of the MFF Regulation; (iii) for annual actions (relating to pilot projects, preparatory actions and agencies) and actions financed under the prerogatives of the Commission, the Commission should provide multiannual estimates; (b) pending legislative proposals: ongoing Commission proposals, with the latest update. The Commission should consider ways of cross-referencing the financial programming with its legislative programming to provide more precise and reliable forecasts. For each legislative proposal, the Commission should indicate whether it is included in the programming communicated at the time of the presentation of the draft budget or after the final adoption of the budget. The Commission should inform the European Parliament and the Council in particular of: (a) all new legislative acts adopted and all pending proposals presented but not included in programming communicated at the time of the draft budget or after the final adoption of the budget (with the corresponding amounts); (b) legislation foreseen in the Commission's annual legislative work programme, with an indication of whether the actions are likely to have a financial impact. Whenever necessary, the Commission should indicate the reprogramming entailed by new legislative proposals. B. AGENCIES AND EUROPEAN SCHOOLS 27. Before presenting a proposal for the creation of a new agency, the Commission should produce a sound, complete and objective impact assessment, taking into account, inter alia, the critical mass of staff and competencies, cost-benefit aspects, subsidiarity and proportionality, the impact on national and Union activities, and the budgetary implications for the expenditure heading concerned. On the basis of that information and without prejudice to the legislative procedures governing the setting up of the agency, the European Parliament and the Council commit themselves, in the framework of budgetary cooperation, to arrive at a timely agreement on the financing of the proposed agency. The following procedural steps shall be applied: \u2014 firstly, the Commission shall systematically present any proposal for setting up a new agency to the first trilogue following the adoption of its proposal, and shall present the financial statement accompanying the legislative proposal for the creation of the agency and shall illustrate the consequences thereof for the remaining period of the financial programming; \u2014 secondly, during the legislative process, the Commission shall assist the legislator in assessing the financial consequences of the amendments proposed. Those financial consequences should be considered during the relevant legislative trilogues; \u2014 thirdly, before the conclusion of the legislative process, the Commission shall present an updated financial statement taking into account potential amendments by the legislator; that final financial statement shall be placed on the agenda of the final legislative trilogue and formally endorsed by the legislator. It shall also be placed on the agenda of a subsequent budgetary trilogue (in urgent cases, in simplified form), in view of reaching an agreement on the financing; \u2014 fourthly, the agreement reached during a trilogue, taking into account the Commission's budgetary assessment with regard to the content of the legislative process, shall be confirmed in a joint declaration. That agreement shall be subject to approval by the European Parliament and by the Council, each in accordance with its own rules of procedure. The same procedure would be applied to any amendment to a legal act concerning an agency which would have an impact on the resources of the agency in question. Should the tasks of an agency be altered substantially without an amendment to the legal act setting up the agency in question, the Commission shall inform the European Parliament and the Council by means of a revised financial statement, so as to allow the European Parliament and the Council to arrive at a timely agreement on the financing of the agency. 28. Relevant provisions from the Common Approach annexed to the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies signed on 19 July 2012 should be duly taken into account in the budgetary procedure. 29. When the creation of a new European school is envisaged by the Board of Governors, a similar procedure is to be applied, mutatis mutandis, for its budgetary implications on the Union budget. PART IV PROTECTION OF THE UNION BUDGET: QUALITY AND COMPARABILITY OF DATA ON BENEFICIARIES 30. In line with the requests of the European Parliament and in response to point 24 of the European Council conclusions of 17 to 21 July 2020, in order to enhance the protection of the Union budget and the European Union Recovery Instrument against fraud and irregularities, the Institutions agree on the introduction of standardised measures to collect, compare and aggregate information and figures on the final recipients and beneficiaries of Union funding, for the purposes of control and audit. 31. To ensure effective controls and audits, it is necessary to collect data on those ultimately benefitting, directly or indirectly, from Union funding under shared management and from projects and reforms supported under Regulation of the European Parliament and of the Council establishing a Recovery and Resilience Facility, including data on beneficial owners of the recipients of the funding. The rules related to the collection and processing of such data will have to comply with applicable data protection rules. 32. To enhance the protection of the Union budget, the Commission will make available an integrated and interoperable information and monitoring system, including a single data-mining and risk-scoring tool, to access and analyse the data referred to in point 31 with a view to a generalised application by Member States. That system would ensure efficient checks on conflicts of interests, irregularities, issues of double funding, and any misuse of the funds. The Commission, the European Anti-Fraud Office (OLAF) and other Union investigative and control bodies should have the necessary access to that data in order to exercise their supervisory functions in relation to the controls and audits that are to be carried out by the Member States in the first place to detect irregularities and conduct administrative investigations into the misuse of the Union funding concerned, and to get a precise overview of its distribution. 33. Without prejudice to the prerogatives of the Institutions under the Treaties, in the course of the legislative procedure relating to the relevant basic acts, the Institutions undertake to sincerely cooperate to ensure the follow-up to the European Council conclusions of 17 to 21 July 2020, in line with the approach described in this Part. Done at Brussels, 16 December 2020. For the European Parliament The President David Maria SASSOLI For the Council The President Michael ROTH For the Commission On behalf of the President Johannes HAHN (1) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (see page 23 of this Official Journal). (2) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (see page 11 of this Official Journal). (3) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (4) Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, p. 1). (5) OJ C 373, 20.12.2013, p. 1. (6) As set out in the Internal Agreement between the Representatives of the Governments of the Member States of the European Union, meeting within the Council, on the financing of European Union aid under the multiannual financial framework for the period 2014 to 2020, in accordance with the ACP-EU Partnership Agreement, and on the allocation of financial assistance for the Overseas Countries and Territories to which Part Four of the Treaty on the Functioning of the European Union applies (OJ L 210, 6.8.2013, p. 1) and the preceding Internal Agreements. ANNEX I INTERINSTITUTIONAL COOPERATION DURING THE BUDGETARY PROCEDURE Part A. Calendar of the budgetary procedure 1. The Institutions shall agree a pragmatic calendar each year in due time before the start of the budgetary procedure on the basis of present practice. 2. In order to ensure that the European Parliament and the Council are able to exercise their budgetary prerogatives in an effective manner, budgetary positions, transfers or other notifications entailing the activation of deadlines shall be submitted taking due account of any recess periods, the dates of which those institutions have informed each other in due time through their respective services. Part B. Priorities for the budgetary procedure 3. In due time before the Commission adopts the draft budget, a trilogue shall be convened to discuss the possible priorities for the budget of the coming financial year and any questions arising from the implementation of the budget of the current financial year, on the basis of the information provided by the Commission in accordance with point 37. Part C. Establishment of the draft budget and updating of estimates 4. The institutions, other than the Commission, are invited to adopt their statement of estimates before the end of March. 5. The Commission shall, each year, present a draft budget showing the Union's actual financing requirements. It shall take into account: (a) forecasts provided by the Member States in relation to the Structural Funds; (b) the capacity for utilising appropriations, while endeavouring to maintain a strict relationship between appropriations for commitments and appropriations for payments; (c) possibilities for starting up new policies through pilot projects, new preparatory actions or both, or for continuing multiannual actions which are coming to an end, after assessing whether it is possible to secure a basic act, within the meaning of the Financial Regulation (definition of a basic act, necessity of a basic act for implementation and exceptions); (d) the need to ensure that any change in expenditure in relation to the previous year is in accordance with the constraints of budgetary discipline. 6. The Institutions shall, as far as possible, avoid entering items in the budget involving insignificant amounts of expenditure on operations. 7. The European Parliament and the Council also undertake to bear in mind the assessment of the possibilities for implementing the budget made by the Commission in its drafts and in connection with the implementation of the budget for the current financial year. 8. In the interests of sound financial management and owing to the effect of major changes in the titles and chapters of the budget nomenclature on the management reporting responsibilities of Commission departments, the European Parliament and the Council undertake to discuss any major changes with the Commission during the conciliation. 9. In the interest of loyal and sound institutional cooperation, the European Parliament and the Council commit to maintaining regular and active contacts at all levels, through their respective negotiators, throughout the whole budgetary procedure and, in particular, during the whole conciliation period with a view to reaching an agreement. The European Parliament and the Council undertake to ensure the timely and constant mutual exchange of relevant information and documents at both formal and informal levels, as well as to hold technical or informal meetings as needed, during the conciliation period, in cooperation with the Commission. The Commission shall ensure timely and equal access to information and documents for the European Parliament and for the Council. 10. Until such time as the Conciliation Committee is convened, the Commission may, if necessary, submit letters of amendment to the draft budget in accordance with Article 314(2) TFEU, including a letter of amendment updating, in particular expenditure estimates for agriculture. The Commission shall submit information on updates to the European Parliament and to the Council for their consideration as soon as it is available. It shall supply the European Parliament and the Council with all the duly justified reasons they may require. Part D. Budgetary procedure before the conciliation procedure 11. A trilogue shall be convened in due time before the Council's reading, to allow the Institutions to exchange their views on the draft budget. 12. In order for the Commission to be able to assess in due time the executability of amendments, envisaged by the European Parliament and by the Council, which create new preparatory actions or pilot projects or which prolong existing ones, the European Parliament and the Council shall inform the Commission of their intentions in that regard, so that a first discussion may already take place at that trilogue. 13. A trilogue may be convened before the votes in plenary of the European Parliament. Part E. Conciliation procedure 14. If the European Parliament adopts amendments to the Council's position, the President of the Council shall, during the same plenary sitting, take note of the differences in the position of the two institutions and give his/her agreement for the President of the European Parliament to convene the Conciliation Committee immediately. The letter convening the Conciliation Committee shall be sent at the latest on the first working day of the week following the end of the parliamentary part-session during which the plenary vote was delivered, and the conciliation period shall start on the following day. The 21-day period shall be calculated in accordance with Regulation (EEC, Euratom) No 1182/71 of the Council (1). 15. If the Council cannot agree on all the amendments adopted by the European Parliament, it should confirm its position by letter sent before the first meeting foreseen during the conciliation period. In such case, the Conciliation Committee shall proceed in accordance with the conditions laid down in the following points. 16. The Conciliation Committee shall be chaired jointly by representatives of the European Parliament and of the Council. Meetings of the Conciliation Committee shall be chaired by the co-chair from the institution hosting the meeting. Each institution, in accordance with its own rules of procedure, shall designate its participants for each meeting and set out its mandate for the negotiations. The European Parliament and the Council shall be represented at an appropriate level in the Conciliation Committee, such that each delegation can commit politically its respective institution, and that actual progress towards the final agreement may be made. 17. In accordance with the second subparagraph of Article 314(5) TFEU, the Commission shall take part in the Conciliation Committee's proceedings and shall take all the necessary initiatives with a view to reconciling the positions of the European Parliament and of the Council. 18. Trilogues shall take place throughout the conciliation procedure, at different levels of representation, with the aim of resolving outstanding issues and preparing the ground for an agreement to be reached in the Conciliation Committee. 19. Meetings of the Conciliation Committee and trilogues shall be held alternately at the premises of the European Parliament and of the Council, with a view to an equal sharing of facilities, including interpretation facilities. 20. The dates of the meetings of the Conciliation Committee and the trilogues shall be set in advance by agreement of the Institutions. 21. A common set of documents (\"input documents\") comparing the various steps of the budgetary procedure shall be made available to the Conciliation Committee (2). Those documents shall include \"line by line\" figures, totals by MFF headings and a consolidated document with figures and remarks for all budget lines deemed technically \"open\". Without prejudice to the final decision of the Conciliation Committee, a specific document shall list all budget lines deemed technically closed (3). Those documents shall be classified by budgetary nomenclature. Other documents shall also be attached to the input documents for the Conciliation Committee, including a letter of executability from the Commission on the Council's position and the European Parliament's amendments, and any letters from other institutions concerning the Council's position or the European Parliament's amendments. 22. With a view to reaching agreement by the end of the conciliation period, trilogues shall: (a) define the scope of the negotiations on the budgetary issues to be addressed; (b) endorse the list of the budget lines deemed technically closed, subject to the final agreement on the entire budget of the financial year; (c) discuss issues identified under point (a) with a view to reaching possible agreements to be endorsed by the Conciliation Committee; (d) address thematic issues, including by headings of the MFF. Tentative conclusions shall be drawn jointly during or immediately after each trilogue, and, simultaneously, the agenda of the following meeting shall be agreed. Those conclusions shall be registered by the institution hosting the trilogue and shall be deemed provisionally approved after 24 hours, without prejudice to the final decision of the Conciliation Committee. 23. The conclusions of trilogues and a document for possible endorsement shall be available to the Conciliation Committee at its meetings, together with the budget lines in respect of which an agreement has been tentatively reached during the trilogues. 24. The joint text provided for in Article 314(5) TFEU shall be established by the secretariats of the European Parliament and of the Council with the assistance of the Commission. It shall consist of a letter of transmission addressed by the chairs of the two delegations to the Presidents of the European Parliament and of the Council, containing the date of the agreement at the Conciliation Committee, and annexes which shall include: (a) line by line figures for all budget items and summary figures by MFF headings; (b) a consolidated document, indicating the figures and final text of all lines that have been amended during the conciliation procedure; (c) the list of the lines not amended with regard to the draft budget or the Council's position on it. The Conciliation Committee may also approve conclusions and possible joint statements in relation to the budget. 25. The joint text shall be translated into the official languages of the institutions of the Union (by the services of the European Parliament) and shall be submitted for approval of the European Parliament and of the Council within a period of 14 days from the date of the agreement on the joint text referred to point 24. The budget shall be subject to legal-linguistic revision after the adoption of the joint text by integrating the annexes of the joint text with the budget lines not amended during the conciliation procedure. 26. The institution hosting the meeting (trilogue or conciliation) shall provide interpretation facilities with a full linguistic regime applicable to the Conciliation Committee meetings and an ad hoc linguistic regime for the trilogues. The institution hosting the meeting shall provide for the copying and distribution of room documents. The services of the Institutions shall cooperate in the encoding of the results of the negotiations in order to finalise the joint text. Part F. Amending budgets General principles 27. Bearing in mind that amending budgets are frequently focused on specific and sometimes urgent issues, the Institutions agree on the following principles to ensure appropriate interinstitutional cooperation for a smooth and swift decision-making process for amending budgets while avoiding, insofar as possible, having to convene a conciliation meeting for amending budgets. 28. As far as possible, the Institutions shall endeavour to limit the number of amending budgets. Calendar 29. The Commission shall inform the European Parliament and the Council in advance of the possible dates of adoption of draft amending budgets, without prejudice to the final date of adoption. 30. The European Parliament and the Council, each in accordance with its internal rules of procedure, shall endeavour to examine the draft amending budget proposed by the Commission at an early opportunity after its adoption by the Commission. 31. In order to speed up the procedure, the European Parliament and the Council shall ensure that their respective calendars of work are coordinated as far as possible in order to enable proceedings to be conducted in a coherent and convergent way. They shall therefore seek as soon as possible to establish an indicative timetable for the various stages leading to the final adoption of the amending budget. The European Parliament and the Council shall take into account the relative urgency of the amending budget and the need to approve it in due time to be effective during the financial year concerned. Cooperation during the readings 32. The Institutions shall cooperate in good faith throughout the procedure, clearing the way, as far as possible, for the adoption of amending budgets at an early stage of the procedure. Where appropriate, and when there is a potential divergence, the European Parliament or the Council, before each takes its final position on the amending budget, or the Commission at any time, may propose that a specific trilogue be convened to discuss the divergences and to try to reach a compromise. 33. All draft amending budgets proposed by the Commission and not yet finally approved shall be entered systematically on the agenda of trilogues planned for the annual budgetary procedure. The Commission shall present the draft amending budgets and the European Parliament and the Council shall, as far as possible, make known their respective positions ahead of the trilogue. 34. If a compromise is reached during a trilogue, the European Parliament and the Council undertake to consider the results of the trilogue when deliberating on the amending budget in accordance with the TFEU and their rules of procedure. Cooperation after the readings 35. If the European Parliament approves the position of the Council without amendments, the amending budget shall be adopted in accordance with the TFEU. 36. If the European Parliament adopts amendments by a majority of its component members, point (c) of Article 314(4) TFEU shall apply. However, before the Conciliation Committee meets, a trilogue shall be called: (a) if an agreement is reached during that trilogue and subject to the agreement of the European Parliament and of the Council on the results of the trilogue, the conciliation shall be closed by an exchange of letters without a meeting of the Conciliation Committee; (b) if no agreement is reached during that trilogue, the Conciliation Committee shall meet and organise its work in accordance with the circumstances, with a view to completing the decision-making process as much as possible before the 21-day deadline laid down in Article 314(5) TFEU. The Conciliation Committee may conclude by an exchange of letters. Part G. Budget implementation, payments and reste \u00e0 liquider (RAL) 37. Given the need to ensure an orderly progression of the total appropriations for payments in relation to the appropriations for commitments so as to avoid any abnormal shift of RAL from one year to another, the Institutions agree to monitor closely the payment forecasts and the level of the RAL so as to mitigate the risk of hampering the implementation of Union programmes because of a lack of payment appropriations at the end of the MFF. In order to ensure a manageable level and profile for the payments in all headings, de-commitment rules shall be applied strictly in all headings, in particular the rules for automatic de-commitments. In the course of the budgetary procedure, the Institutions shall meet regularly with a view to jointly assessing the state of play and the outlook for budgetary implementation in the current and future financial years. That assessment shall take the form of dedicated interinstitutional meetings at the appropriate level, before which the Commission shall provide the detailed state of play, broken down by fund and Member State, on payment implementation, on transfers, on reimbursement claims received and revised forecasts, including long-term forecasts, where applicable. In particular, in order to ensure that the Union can fulfil all its financial obligations stemming from existing and future commitments in the period 2021-2027 in accordance with Article 323 TFEU, the European Parliament and the Council shall analyse and discuss the Commission's estimates as to the required level of payment appropriations. Part H. Cooperation as regards the European Union Recovery Instrument (4) 38. For the sole purpose of addressing the consequences of the COVID-19 crisis, the Commission will be empowered to borrow funds on capital markets on behalf of the Union up to EUR 750 000 million in 2018 prices, of which up to EUR 390 000 million in 2018 prices may be used for expenditure and up to EUR 360 000 million in 2018 prices may be used for providing loans in accordance with Article 5(1) of the Own Resources Decision. As provided for in the EURI Regulation, the amount to be used for expenditure constitutes external assigned revenue for the purposes of Article 21(5) of the Financial Regulation. 39. The Institutions agree that the role of the European Parliament and of the Council, where acting in their capacity of budgetary authority, needs to be enhanced in relation to the external assigned revenue under the European Union Recovery Instrument, with a view to ensuring a proper oversight of and involvement in the use of such revenue, within the limits set out in the EURI Regulation and, as appropriate, in the relevant sectoral legislation. The Institutions also agree on the need to ensure full transparency and visibility of all funds under the European Union Recovery Instrument. External assigned revenue under the European Union Recovery Instrument 40. Given the need to ensure an appropriate involvement of the European Parliament and of the Council in the governance of external assigned revenue under the European Union Recovery Instrument, the Institutions agree on the procedure set out in points 41 to 46. 41. The Commission will provide detailed information with its draft estimates in the context of the budgetary procedure. Such information shall include detailed estimates of commitment appropriations and payment appropriations as well as of legal commitments, broken down by heading and by programme that receives assigned revenue under the EURI Regulation. The Commission will provide any additional relevant information requested by the European Parliament or by the Council. The Commission will attach to the draft budget a document compiling all relevant information concerning the European Union Recovery Instrument, including summary tables aggregating budget appropriations and assigned revenue under the European Union Recovery Instrument. That document will be part of the annex to the general budget of the Union on external assigned revenue provided for in point 44. 42. The Commission will present regular updates of the information referred to in point 41 throughout the financial year and at least ahead of each dedicated meeting as referred to in point 45. The Commission will make the relevant information available to the European Parliament and to the Council in time to allow meaningful discussions and deliberations on corresponding planning documents, including before the Commission adopts relevant decisions. 43. The Institutions will meet regularly in the context of the budgetary procedure with a view to jointly assessing the implementation of external assigned revenue under the European Union Recovery Instrument, in particular the state of play and outlook and to discuss the annual estimates provided with the respective draft budgets and their distribution, with due regard to the limitations and conditions set out in the EURI Regulation and, as appropriate, in relevant sectoral legislation. 44. The European Parliament and the Council will attach to the general budget of the Union in the form of an annex a document setting out all the budget lines that receive assigned revenue under the European Union Recovery Instrument. Moreover, they will use the budget structure for accommodating the assigned revenue under the European Union Recovery Instrument, and in particular the budgetary remarks, to exercise due control over the use of that revenue. In accordance with Article 22 of the Financial Regulation, the European Parliament and the Council will include in the statement of expenditure remarks, including general remarks, showing which budget lines may receive the appropriations corresponding to the revenue assigned on the basis of the EURI Regulation and indicating relevant amounts. The Commission, in exercising its responsibility for implementing the assigned revenue, undertakes to take due account of such remarks. 45. The Institutions agree to organise dedicated interinstitutional meetings at the appropriate level with a view to assessing the state of play and outlook for external assigned revenue under the European Union Recovery Instrument. Those meetings will take place at least three times in a financial year soon before or after the budgetary trilogues. Furthermore, the Institutions shall meet on an ad hoc basis if one institution provides a reasoned request. The European Parliament and the Council may at any time present written observations concerning the implementation of external assigned revenue. The Commission undertakes to take due account of any remarks and suggestions made by the European Parliament and by the Council. Those meetings may address significant deviations in European Union Recovery Instrument expenditure, in line with point 46. 46. The Commission shall provide detailed information about any deviation from its initial forecasts prior to a dedicated interinstitutional meeting as referred to in point 45 and on an ad hoc basis in case of a significant deviation. A deviation from forecasted European Union Recovery Instrument expenditure is significant if the expenditure deviates from the forecast for a given financial year and for a given programme by more than 10 %. In case of significant deviations from initial forecasts, the Institutions will discuss the matter, if either the European Parliament or the Council requests to do so within two weeks after notice of such a significant deviation. The Institutions will jointly assess the matter with a view to finding common ground within three weeks of the request for a meeting. The Commission will take utmost account of any comments received. The Commission undertakes not to take any decision until the deliberations have been concluded or the period of three weeks has expired. In the latter case, the Commission shall duly justify its decision. In the event of urgency, the Institutions may agree to shorten the deadlines by one week. Loans provided under the European Union Recovery Instrument 47. In order to ensure full information as well as transparency and visibility as regards the loan component of the European Union Recovery Instrument, the Commission will provide detailed information about loans provided to Member States under the European Union Recovery Instrument together with its draft estimates, while paying particular attention to sensitive information, which is protected. 48. Information about loans under the European Union Recovery Instrument will be shown in the budget in accordance with the requirements in point (d) of Article 52(1) of the Financial Regulation and will also include the annex referred to in point (iii) of that point. (1) Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits (OJ L 124, 8.6.1971, p. 1). (2) The various steps include: the budget of the current financial year (including adopted amending budgets); the initial draft budget; the Council's position on the draft budget; the European Parliament's amendments to the Council's position and the letters of amendment presented by the Commission (if not yet fully approved by the Institutions). (3) A budget line deemed technically closed is a line for which there is no disagreement between the European Parliament and the Council, and for which no letter of amendment has been presented. (4) Where the Commission submits a proposal for an act of the Council under Article 122 TFEU with potential appreciable budgetary implications, the procedure as set out in the joint declaration of the European Parliament, the Council and the Commission of 16 December 2020 on budgetary scrutiny of new proposals based on Article 122 TFEU with potential appreciable implications for the Union budget (OJ C 444, 22.12.2020, p. 5) is applicable. ANNEX II INTERINSTITUTIONAL COOPERATION ON A ROADMAP TOWARDS THE INTRODUCTION OF NEW OWN RESOURCES Preamble A. The Institutions are committed to sincere and transparent cooperation and the work towards the implementation of a roadmap for the introduction of new own resources over the duration of the MFF 2021-2027. B. The Institutions recognise the importance of the context of the European Union Recovery Instrument, in which the new own resources should be introduced. C. For the sole purpose of addressing the consequences of the COVID-19 crisis, the Commission will be empowered, under Article 5(1) of the Own Resources Decision, to borrow funds on capital markets on behalf of the Union up to EUR 750 000 million in 2018 prices, of which up to EUR 390 000 million in 2018 prices may be used for expenditure in accordance with point (b) of Article 5(1) of that Decision. D. The repayment of the principal of such funds to be used for expenditure under the European Union Recovery Instrument and the related interest due will have to be financed by the general budget of the Union, including by sufficient proceeds from new own resources introduced after 2021. All related liabilities will be fully repaid by 31 December 2058 at the latest as provided for in the second subparagraph of Article 5(2) of the Own Resources Decision. The annual amounts payable will depend on the maturities of the bonds issued and the debt repayment strategy, while respecting the limit for the repayment of the principal of the funds referred to in the third subparagraph of that paragraph set at 7,5 % of the maximum amount to be used for expenditure referred to in point (b) of Article 5(1) of that Decision. E. The expenditure from the Union budget related to the repayment of the European Union Recovery Instrument should not lead to an undue reduction in programme expenditure or investment instruments under the MFF. It is also desirable to mitigate the increases in the GNI-based own resource for the Member States. F. Therefore, and in order to enhance the credibility and sustainability of the European Union Recovery Instrument repayment plan, the Institutions will work towards introducing sufficient new own resources with a view to covering an amount corresponding to the expected expenditure related to the repayment. In accordance with the principle of universality, this would not imply an earmarking or assignment of any particular own resource to cover a specific type of expenditure. G. The Institutions acknowledge that the introduction of a basket of new own resources should support the adequate financing of Union expenditure in the MFF, while reducing the share of national GNI-based contributions in the financing of the Union's annual budget. The diversification of revenue sources in turn could facilitate the attainment of a better focus of expenditure at Union level on priority areas and on common public goods with high efficiency gains compared to national spending. H. Therefore, new own resources should be aligned with Union policy objectives and should support Union priorities such as the European Green Deal and a Europe fit for the Digital Age, and should contribute to fair taxation and the strengthening of the fight against tax fraud and tax evasion. I. The Institutions agree that new own resources should preferably be created in a way that allows generating \"fresh money\". In parallel, they aim at reducing red tape and the burden for companies, especially for small and medium-sized enterprises (SMEs), and for citizens. J. New own resources should fulfil the criteria of simplicity, transparency, predictability and fairness. The calculation, transfer and control of the new own resources should not lead to an excessive administrative burden for Union institutions and national administrations. K. Considering the heavy procedural requirements for the introduction of new own resources, the Institutions agree that the necessary reform of the own resources system should be achieved with a limited number of revisions of the Own Resources Decision. L. The Institutions therefore agree to cooperate during the period 2021-2027 on the basis of the principles set out in this Annex in order to work towards the introduction of new own resources in line with the roadmap set out in Part B and with the dates set out therein. M. The Institutions also recognise the importance of the tools for Better Law-Making set out in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (1), in particular of the impact assessment. Part A. Principles for the implementation 1. The Commission will make the necessary legislative proposals for new own resources and for potential other new own resources as referred to in point 10 in accordance with Better Law-Making principles. It will in that context take due account of suggestions made by the European Parliament and by the Council. Those legislative proposals will be accompanied by the relevant own resources implementing legislation. 2. The Institutions agree on the following guiding principles for the introduction of a basket of new own resources: (a) raising an amount through the new own resources that is sufficient to cover the level of overall expected expenditure for the repayment of the principal and the interest of the funds borrowed to be used for expenditure referred to in point (b) of Article 5(1) of the Own Resources Decision, while respecting the principle of universality. Revenue from own resources in excess of the needs for repayment shall continue to fund the Union budget as general revenue in accordance with the principle of universality; (b) expenditure covering the financing costs of the European Union Recovery Instrument shall aim at not reducing expenditure for Union programmes and funds; (c) aligning the own resources with the Union priorities, such as the fight against climate change, the circular economy, Europe fit for the Digital Age and contributing to fair taxation and to the strengthening of the fight against tax fraud and tax evasion; (d) respecting the criteria of simplicity, transparency, and fairness; (e) ensuring stability and predictability of the revenue flow; (f) not leading to an excessive administrative burden for Union institutions and national administrations; (g) preferably generating additional \"fresh\" revenues; (h) in parallel, aiming at reducing red tape and the burden for companies, especially for SMEs, and for citizens. 3. The European Parliament and the Council will analyse, discuss and proceed without undue delay with the legislative proposals referred to in point 1 in accordance with their internal procedures with a view to facilitating a swift decision. After the Commission has presented its proposals, members of the European Parliament and representatives of the Council will in the course of their deliberations meet in the presence of the Commission representatives in order to inform each other about the respective state of play. In addition, the Institutions will enter into a regular dialogue to take stock of progress as regards the roadmap. Part B. Roadmap towards the introduction of new own resources First step: 2021 4. As a first step, a new own resource will be introduced to apply as of 1 January 2021 composed of a share of revenues from national contributions calculated on the weight of non-recycled plastic packaging waste as provided for in the Own Resources Decision. That decision is scheduled to enter into force in January 2021, subject to approval by Member States in accordance with their respective constitutional requirements. 5. The Commission will accelerate its work and, following impact assessments launched in 2020, put forward proposals on a carbon border adjustment mechanism and on a digital levy as well as an accompanying proposal to introduce new own resources on that basis by June 2021 with a view to their introduction at the latest by 1 January 2023. 6. The Commission will review the EU Emissions Trading System in spring 2021, including its possible extension to aviation and maritime. It will propose an own resource based on the EU Emissions Trading System by June 2021. 7. The Institutions agree that the carbon border adjustment mechanism and the EU Emissions Trading System are thematically interlinked and that it would therefore be warranted to discuss them in the same spirit. Second step: 2022 and 2023 8. Following the applicable procedures under the Treaties and subject to approval by Member States in accordance with their respective constitutional requirements, these new own resources are envisaged to be introduced by 1 January 2023. 9. The Council will deliberate on these new own resources by 1 July 2022 at the latest in view of their introduction by 1 January 2023. Third step: 2024-2026 10. The Commission will, based on impact assessments, propose additional new own resources, which could include a Financial Transaction Tax and a financial contribution linked to the corporate sector or a new common corporate tax base. The Commission shall endeavour to make a proposal by June 2024. 11. Following the applicable procedures under the Treaties and subject to approval by Member States in accordance with their respective constitutional requirements, such additional new own resources are envisaged to be introduced by 1 January 2026. 12. The Council will deliberate on these new own resources by 1 July 2025 at the latest in view of their introduction by 1 January 2026. (1) Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1).", "summary": "Interinstitutional agreement on budgetary discipline, cooperation, sound financial management and own resources Interinstitutional agreement on budgetary discipline, cooperation, sound financial management and own resources SUMMARY OF: Interinstitutional Agreement between the European Parliament, the Council and the European Commission on budgetary discipline, cooperation in budgetary matters and sound financial management WHAT IS THE AIM OF THIS INTERINSTITUTIONAL AGREEMENT? Over the period of the multiannual financial framework (MFF) 2021-2027, the interinstitutional agreement (IIA) aims to: set out rules on cooperation between the European Parliament, the Council and the European Commission on budgetary matters, in line with the principles of budgetary discipline and sound financial management; improve the functioning of the European Union (EU) annual budgetary procedure and the cooperation between the 3 relevant institutions during this procedure; implement cooperation and draw up a roadmap towards introducing new own resources. These may contribute to covering the repayment of the expected expenditure mobilised through the EU Recovery Instrument under Regulation (EU) 2020/2094 (see summary), which supports recovery in the aftermath of the COVID-19 crisis. KEY POINTS The agreement is made up of 4 parts. Part I: The MFF and special instruments This part contains complementary details regarding the 2021-2027 MFF, including the mobilisation procedures of special instruments not included in the MFF: the European Globalisation Adjustment Fund; the Solidarity and Emergency Aid Reserve, designed to tackle, among other things, major disasters in the EU or in candidate countries under the EU Solidarity Fund (see summary); the Brexit Adjustment Reserve; the Single Margin Instrument; the Flexibility Instrument. Part II: Interinstitutional cooperation in budgetary matters This part aims to improve the cooperation between the Parliament, the Council and the Commission in relation to budgetary matters. This includes the following. The 3 institutions agree to facilitate the adoption of a proposed new MFF or a proposed revision to the current MFF by taking necessary measures, such as meetings and exchange of information. Budgetary transparency means the Commission must prepare an annual report on: the assets and liabilities of the EU, including those arising from borrowing and lending operations,EU financial interventions which are not included in the EU\u2019s general budget (such as the previous European Development Fund),the expenditure incurred by Member States in the context of enhanced cooperation, where it is not included in the general budget,how the EU budget contributes to: the fight against climate change,halting and reversing the decline of biodiversity,promoting equality between women and men, and rights and equal opportunities for all,the implementation of the UN sustainable development goals. The Commission will also prepare an annual report on the implementation of the European Union Recovery Instrument (NextGenerationEU). How financial rules are incorporated in legislative acts and how these are dealt with in the annual budget procedure. Specific rules on expenditure relating to fisheries agreements and the financing of the common foreign and security policy (CFSP). Part III: Sound financial management of EU funds This part deals with financial programming, which means the Commission must submit to the Council and the Parliament financial programming for the MFF twice a year (with some category exemptions), structured by heading, policy area and budget line, and should identify the legislation in force, distinguishing between multiannual programmes and annual actions. This part also deals with the cooperation procedures which apply when a new agency is created, or when an amendment to a legal act concerning an agency would have an impact on that agency\u2019s resources. A similar procedure applies when the creation of a new European school is envisaged. Part IV: Protecting the EU budget: data on beneficiaries To enhance the protection of the EU budget and the EU Recovery Instrument against fraud and irregularities, the institutions agree to introduce standardised measures to collect, compare and aggregate data on the final recipients and beneficiaries of EU funding for the purposes of controls and audits. In particular: to ensure effective controls and audits, it is necessary to collect data on those ultimately benefitting, directly or indirectly, from EU funding under shared management and from projects and reforms supported under the Recovery and Resilience Facility; the Commission will make available an integrated and interoperable information and monitoring system, including a single data-mining and risk-scoring tool to access and analyse the data. The Commission, the European Anti-Fraud Office (OLAF) and other EU investigative and control bodies should have access to the data to exercise their supervision over Member States\u2019 audits. Two Annexes form an integral part of the IIA. Annex I lays down additional detailed rules for cooperation between the institutions during the budgetary procedure. These cover: agreement on a pragmatic calendar; priority setting; establishing the draft budget and updating of estimates; specific decision-making procedures at different stages of the budget process; amending budgets; the issue of outstanding commitments (not yet translated into payments); cooperation as regards the European Union Recovery Instrument. Annex II sets out principles of the interinstitutional cooperation in order to introduce new own resources with a view to covering the expected expenditure related to the repayment of NextGenerationEU. As a first step, a new own resource will be introduced from 1 January 2021 made up of a share of revenues from national contributions, calculated on the weight of non-recycled plastic packaging waste. Moreover, the Commission will propose to the Council the introduction of new own resources based on a digital levy and on a carbon border adjustment mechanism. The Commission will also review the Emissions Trading System in spring 2021 and propose to the Council a new own resource on that basis in June 2021. These 3 new own resources are envisaged to be introduced by 1 January 2023, provided the necessary legislative procedures are completed. This would constitute the second step. As a third step, the Commission aims to propose to the Council by June 2024 an additional new own resource. This proposal could take the form of a Financial Transaction Tax and a financial contribution linked to the corporate sector or a new common corporate tax base. These are envisaged to be introduced by 2026, provided the necessary legislative procedures are completed. FROM WHEN DOES THE AGREEMENT APPLY? The IIA entered into force on 16 December 2020. BACKGROUND In December 2020, the European Parliament, the Council and the Commission concluded an IIA on budgetary discipline, cooperation on budgetary matters and sound financial management as well as on new own resources, including a roadmap towards the introduction of new own resources. The IIA was adopted in parallel to the multiannual financial framework (MFF) Regulation, the EU\u2019s 7-year plan covering the 2021-2027 period. The IIA forms part of a package of legislation associated with the MFF: The MFF 2021-2027 is set out in detail in Regulation (EU, Euratom) 2020/2093 (see summary). New rules on how the EU is funded are set out in the decision on own resources: Decision (EU, Euratom) 2020/2053 (see summary). The EU Recovery Instrument is set out in Regulation (EU) 2020/2094 and supports recovery in the aftermath of the COVID-19 pandemic. For more information, see: 2021-2027 long-term EU budget (European Commission) Multiannual financial framework 2021-2027 (European Commission) EU\u2019s next long-term budget & NextGenerationEU: Key facts and figures (European Commission) Recovery plan for Europe (European Commission). MAIN DOCUMENT Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (OJ L 433I, 22.12.2020, pp. 28-46) RELATED DOCUMENTS Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, pp. 11-22) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I, 22.12.2020, pp. 23-27) Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, pp. 1-10) Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (OJ L 311, 14.11.2002, pp. 3-8) Successive amendments to Regulation (EC) No 2012/2002 have been incorporated into the original text. This consolidated version is of documentary value only. last update 06.04.2021"}
{"article": "22.12.2020 EN Official Journal of the European Union LI 433/23 COUNCIL REGULATION (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 122 thereof, Having regard to the proposal from the European Commission, Whereas: (1) In order to contain the spread of COVID-19, which on 11 March 2020 was declared a pandemic by the World Health Organization, Member States have adopted a set of unprecedented measures. (2) The unprecedented measures taken in response to the exceptional situation caused by COVID-19, which is beyond the control of Member States, have caused significant disturbances to economic activity which are reflected in a steep decline in gross domestic product and a significant impact on employment, social conditions, poverty and inequalities. In particular, those measures have disrupted supply chains and production and caused absences from the workplace. In addition, the provision of many services has become very difficult or impossible. At the same time, consumer demand has dropped. Many businesses are experiencing liquidity shortages, and their solvency is at risk, while the financial markets are very volatile. Key sectors like travel and tourism are particularly hard hit. More broadly, those measures have already led or will lead to severe deterioration of the financial situation of many businesses in the Union. (3) The crisis caused by COVID-19 has spread quickly in the Union and in third countries. A sharp contraction of growth in the Union is foreseen for 2020. Recovery risks being very uneven in different Member States, increasing the divergence between national economies. The different fiscal abilities of Member States to provide financial support where it is needed most for recovery and the divergence between Member States\u2019 measures endanger the single market as well as social and territorial cohesion. (4) A comprehensive set of measures is needed for economic recovery. That set of measures requires substantial amounts of public and private investment to set the Union firmly on the path towards a sustainable and resilient recovery, create high-quality jobs, support social inclusion and repair the immediate damage brought by the COVID-19 crisis, whilst supporting the Union\u2019s green and digital priorities. (5) The exceptional situation caused by COVID-19, which is beyond the control of Member States, calls for a coherent and unified approach at Union level. In order to prevent further deterioration of the economy, employment and social cohesion and to boost a sustainable and resilient recovery of economic activity, an exceptional and coordinated programme of economic and social support should be put in place, in a spirit of solidarity between Member States, in particular for those Member States that have been particularly hard hit. (6) As this Regulation is an exceptional response to temporary but extreme circumstances, the support provided under it should only be made available for the purposes of addressing the adverse economic consequences of the COVID-19 crisis or the immediate funding needs to avoid a re-emergence of the COVID-19 crisis. (7) The support under the instrument established by this Regulation (the \u2018Instrument\u2019) should in particular focus on measures to restore labour markets and social protection as well as health care systems, to reinvigorate potential for sustainable growth and employment in order to strengthen cohesion among Member States and support their transition towards a green and digital economy, to provide support to businesses affected by the impact of the COVID-19 crisis, in particular small and medium-sized enterprises, as well as support for investment in activities that are essential for strengthening sustainable growth in the Union including direct financial investment in enterprises, measures for research and innovation in response to the COVID-19 crisis, for capacity building at Union level to enhance future crisis preparedness, for maintaining efforts to ensure a just transition to a climate-neutral economy, and support for agriculture and development in rural areas in addressing the impact of the COVID-19 crisis. (8) To ensure a sustainable and resilient recovery throughout the Union and facilitate the implementation of economic support, the established mechanisms of spending through Union programmes under the multiannual financial framework are to be used. Support under those programmes is to be provided in the form of non-repayable support, loans, and provisioning for budgetary guarantees. The allocation of financial resources should reflect the extent to which those programmes are capable of contributing to the objectives of the Instrument. Contributions to those programmes under the Instrument should be subject to strict compliance with the objectives of the Instrument, which are linked to supporting recovery in the aftermath of the COVID-19 crisis. (9) In view of the nature of the measures to be financed, one part of the amounts available under the Instrument should be used for loans to Member States, whereas the other part of the amounts should constitute external assigned revenue for the purpose of Article 21(5) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (1) (the \u2018Financial Regulation\u2019) and should be used for non-repayable support, support through financial instruments or provisioning for budgetary guarantees and related expenditure by the Union. To that effect, as part of the necessary measures under this Regulation, it is appropriate to enable Article 21(5) of the Financial Regulation to comprise the assigning under this Regulation, as a basic act, of a part of the revenue provided for under the exceptional and temporary empowerment provided for in the Council Decision on the system of own resources of the European Union and repealing Council Decision 2014/335/EU, Euratom (2) (the \u2018Own Resources Decision\u2019). (10) While point (c) of Article 12(4) and Article 14(3) of the Financial Regulation apply to commitment and payment appropriations made available in relation to the external assigned revenue under this Regulation, in view of the time limits set for the different types of support, commitment appropriations resulting from that external assigned revenue should not be automatically carried over beyond the respective end dates, except for commitment appropriations necessary for technical and administrative assistance for implementation of the measures set out in the Instrument. (11) Commitment appropriations for non-repayable support should be made available automatically up to the authorised amount. Liquidity should be managed effectively, so that funds are raised only when legal commitments need to be honoured through corresponding payment appropriations. (12) Given the importance of using the amounts during the first years of the implementation of the Instrument, it is appropriate to review the progress achieved in the implementation of the Instrument and the use of the support allocated in accordance with this Regulation. To that effect, the Commission should prepare a report by 31 October 2022. (13) Article 135(2) of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (3) (the \u2018Withdrawal Agreement\u2019) provides that amendments to Decision 2014/335/EU, Euratom that are adopted on or after the date of entry into force of the Withdrawal Agreement are not to apply to the United Kingdom insofar as those amendments have an impact on the United Kingdom\u2019s financial obligations. The support under this Regulation and the corresponding increase of the own resources ceiling of the Union would have an impact on the United Kingdom\u2019s financial obligations. Article 143(1) of the Withdrawal Agreement limits the liability of the United Kingdom for its share of the contingent financial liabilities of the Union to those contingent financial liabilities of the Union arising from financial operations taken by the Union before the date of entry into force of the Withdrawal Agreement. Any contingent financial liability of the Union arising from support under this Regulation would be subsequent to the date of entry into force of the Withdrawal Agreement. Therefore, this Regulation should not apply to and in the United Kingdom, HAS ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. In order to support the recovery in the aftermath of the COVID-19 crisis, this Regulation establishes the European Union Recovery Instrument (the \u2018Instrument\u2019). 2. Support under the Instrument shall in particular finance the following measures to tackle the adverse economic consequences of the COVID-19 crisis or the immediate funding needs to avoid a re-emergence of that crisis: (a) measures to restore employment and job creation; (b) measures in the form of reforms and investments to reinvigorate the potential for sustainable growth and employment in order to strengthen cohesion among Member States and increase their resilience; (c) measures for businesses affected by the economic impact of the COVID-19 crisis, in particular measures that benefit small and medium-sized enterprises as well as support for investment in activities that are essential for strengthening sustainable growth in the Union, including direct financial investment in enterprises; (d) measures for research and innovation in response to the COVID-19 crisis; (e) measures for increasing the level of the Union\u2019s crisis preparedness and enabling a quick and effective Union response in the event of major emergencies, including measures such as stockpiling of essential supplies and medical equipment and acquiring the necessary infrastructures for rapid crisis response; (f) measures to ensure that a just transition to a climate-neutral economy will not be undermined by the COVID-19 crisis; (g) measures to address the impact of the COVID-19 crisis on agriculture and rural development. 3. The measures referred to in paragraph 2 shall be carried out under specific Union programmes and in accordance with the relevant Union acts laying down rules for those programmes whilst fully respecting the objectives of the Instrument. Those measures shall include technical and administrative assistance for their implementation. Article 2 Financing of the Instrument and allocation of funds 1. The Instrument shall be financed up to an amount of EUR 750 000 million in 2018 prices on the basis of the empowerment provided for in Article 5 of the Own Resources Decision. For the purposes of implementation under the specific Union programmes, the amount referred to in the first subparagraph shall be adjusted on the basis of a fixed deflator of 2 % per year. For commitment appropriations that deflator shall apply to the annual instalments. 2. The amount referred to in paragraph 1 shall be allocated as follows: (a) support of up to EUR 384 400 million in 2018 prices in the form of non-repayable support and repayable support through financial instruments shall be allocated as follows: (i) up to EUR 47 500 million in 2018 prices for structural and cohesion programmes of the multiannual financial framework 2014-2020 as reinforced until 2022, including support through financial instruments; (ii) up to EUR 312 500 million in 2018 prices for a programme financing recovery and economic and social resilience via support to reforms and investments; (iii) up to EUR 1 900 million in 2018 prices for programmes related to civil protection; (iv) up to EUR 5 000 million in 2018 prices for programmes related to research and innovation, including support through financial instruments; (v) up to EUR 10 000 million in 2018 prices for programmes supporting territories in their transition towards a climate-neutral economy; (vi) up to EUR 7 500 million in 2018 prices for development in rural areas; (b) up to EUR 360 000 million in 2018 prices in loans to Member States for a programme financing recovery and economic and social resilience via support to reforms and investments; (c) up to EUR 5 600 million in 2018 prices for provisioning for budgetary guarantees and related expenditure for programmes aiming at supporting investment operations in the field of Union internal policies. Article 3 Rules for budgetary implementation 1. For the purpose of Article 21(5) of the Financial Regulation, EUR 384 400 million in 2018 prices, of the amount referred to in Article 2(1) of this Regulation, shall constitute external assigned revenue to the Union programmes referred to in point (a) of Article 2(2) of this Regulation and EUR 5 600 million in 2018 prices of that amount shall constitute external assigned revenue to the Union programmes referred to in point (c) of Article 2(2) of this Regulation. 2. EUR 360 000 million in 2018 prices, of the amount referred to in Article 2(1), shall be used for loans to Member States under the Union programmes referred to in point (b) of Article 2(2). 3. Commitment appropriations covering support to the Union programmes referred to in points (a) and (c) of Article 2(2) shall be made available automatically up to the respective amounts referred to in those points as of the date of entry into force of the Own Resources Decision which provides for the empowerment referred to in Article 2(1) of this Regulation. 4. Legal commitments giving rise to expenditure for support as referred to in point (a) of Article 2(2), and, where appropriate, in point (c) of Article 2(2), shall be entered into by the Commission or by its executive agencies by 31 December 2023. Legal commitments of at least 60 % of the amount referred to in point (a) of Article 2(2) shall be entered into by 31 December 2022. 5. Decisions on the granting of the loans referred to in point (b) of Article 2(2) shall be adopted by 31 December 2023. 6. The Union\u2019s budgetary guarantees up to an amount which, in accordance with the relevant provisioning rate set out in the respective basic acts, corresponds to the provisioning for budgetary guarantees referred to in point (c) of Article 2(2), depending on the risk profiles of the supported financing and investment operations, shall be granted only for supporting operations which have been approved by the counterparts by 31 December 2023. The respective budgetary guarantee agreements shall contain provisions requiring that financial operations corresponding to at least 60 % of the amount of those budgetary guarantees are approved by the counterparts by 31 December 2022. Where provisioning for budgetary guarantees is used for non-repayable support related to the financing and investment operations referred to in point (c) of Article 2(2), the related legal commitments shall be entered into by the Commission by 31 December 2023. 7. Paragraphs 4 to 6 of this Article shall not apply to technical and administrative assistance referred to in Article 1(3). 8. Costs from technical and administrative assistance for the implementation of the Instrument, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems for the purposes of this Regulation, shall be financed from the Union budget. 9. Payments related to the legal commitments entered into, decisions adopted and the provisions regarding financial operations approved in accordance with paragraphs 4 to 6 of this Article shall be made by 31 December 2026, with the exception of technical and administrative assistance referred to in Article 1(3) and of cases where, exceptionally, although the legal commitment has been entered into, the decision has been adopted or the operation has been approved, on terms compliant with the deadline applicable under this paragraph, payments after 2026 are necessary for the Union to be able to honour its obligations towards third parties, including as a result of a definitive judgment against the Union. Article 4 Reporting By 31 October 2022, the Commission shall submit to the Council a report on the progress achieved in the implementation of the Instrument and the use of the funds allocated in accordance with Article 2(2). Article 5 Applicability 1. This Regulation shall not be applicable to or in the United Kingdom. 2. References to \u2018Member States\u2019 in this Regulation shall not be understood to include the United Kingdom. Article 6 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 14 December 2020. For the Council The President M. ROTH (1) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (2) Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (OJ L 168, 7.6.2014, p. 105). (3) OJ L 29, 31.1.2020, p. 7.", "summary": "EU Recovery Instrument NextGenerationEU EU Recovery Instrument NextGenerationEU SUMMARY OF: Regulation (EU) 2020/2094 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis WHAT IS THE AIM OF THE REGULATION? It sets up the European Union Recovery Instrument NextGenerationEU to support the recovery from the COVID-19 crisis and sets out how it will operate. KEY POINTS NextGenerationEU is a temporary recovery instrument worth up to \u20ac750 billion in 2018 prices. It is at the heart of the European Union (EU) response to the COVID-19 crisis and aims to support the recovery and build a greener, more digital and more resilient future, in particular to reinvigorate potential for sustainable growth and employment in order to support EU Member States\u2019 transition towards a green and digital economy. The instrument will also help repair the immediate economic and social damage brought about by the COVID-19 crisis and build a post-COVID-19 Europe that is better equipped to deal with current and forthcoming challenges. The centrepiece of NextGenerationEU is the allocation of financing to the Recovery and Resilience Facility \u2014 by offering grants and loans to support reforms and investments in the Member States with a total value of \u20ac672.5 billion in 2018 prices: up to \u20ac312.5 billion will be provided in the form of grants; up to \u20ac360 billion will provide EU loans to individual Member States. These loans will be repaid by those Member States. In addition, NextGenerationEU will reinforce several EU programmes as follows: Cohesion, under the Recovery Assistance for Cohesion and the Territories of Europe (REACT-EU), to help tackle the economic consequences of COVID-19 in the first years of the recovery \u2014 with \u20ac47.5 billion; Just Transition Fund with \u20ac10 billion; Rural development with \u20ac7.5 billion; InvestEU with \u20ac5.6 billion; Union Civil Protection Mechanism, under rescEU, with \u20ac1.9 billion; Horizon Europe, with \u20ac5 billion. To finance NextGenerationEU, the Own Resources Decision (Decision (EU, Euratom) 2020/2053) (see summary) will enable the European Commission to borrow on the capital markets on behalf of the EU. As set out by the Own Resources Decision, repayment can take place over the long term, at the latest until 2058. This will avoid placing immediate pressure on Member States\u2019 national finances and enable them to focus their efforts on the recovery. Additional information: commitment appropriations* for all expenditure, apart from the \u20ac360 billion of loans, should be available as soon as the Own Resources Decision enters into force, with at least 60% committed by 31 December 2022 and any remaining amount by 31 December 2023; decisions on granting the \u20ac360 billion in loans should be adopted by 31 December 2023; specific conditions apply to the EU\u2019s budgetary and investment guarantees. The regulation does not apply to the United Kingdom. The Commission shall submit a report to the Council by 31 October 2022 on how the funds allocated under this instrument are being used. FROM WHEN DOES THE REGULATION APPLY? It has applied since 23 December 2020. BACKGROUND With their combined \u20ac1.8 trillion, NextGenerationEU, and the long-term EU budget 2021-2027, form the largest stimulus package ever financed through the EU budget. The package will also help rebuild a post-COVID-19 Europe, which will be greener, more digital, more resilient and better equipped for the current and forthcoming challenges. In addition to this Regulation, the package also includes: the 2021-2027 multiannual financial framework (Regulation (EU, Euratom) 2020/2093) \u2014 see summary; the interinstitutional agreement on budgetary discipline (see summary); Regulation (EU, Euratom) 2020/2092 on a general regime of conditionality for the protection of the EU budget \u2014 see summary; the Own Resources Decision (Decision (EU, Euratom) 2020/2053). KEY TERMS Commitment appropriations: total cost of legal obligations (contracts, grants agreements/decisions) that may be signed in the current financial year. MAIN DOCUMENT Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I, 22.12.2020, pp. 23-27) RELATED DOCUMENTS Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (OJ L 433I, 22.12.2020, pp. 28-46) Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, pp. 1-10) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222) last update 20.05.2021"}
{"article": "23.11.2011 EN Official Journal of the European Union L 306/1 REGULATION (EU) No 1173/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 November 2011 on the effective enforcement of budgetary surveillance in the euro area THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 136, in combination with Article 121(6) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Member States whose currency is the euro have a particular interest in and a responsibility to conduct economic policies that promote the proper functioning of the economic and monetary union and to avoid policies that jeopardise that functioning. (2) The Treaty on the Functioning of the European Union (TFEU) allows the adoption of specific measures in the euro area which go beyond the provisions applicable to all Member States, for the purpose of ensuring the proper functioning of the economic and monetary union. (3) Experience gained and mistakes made during the first decade of the economic and monetary union show a need for improved economic governance in the Union, which should be built on stronger national ownership of commonly agreed rules and policies and on a more robust framework at the level of the Union for the surveillance of national economic policies. (4) The improved economic governance framework should rely on several interlinked and coherent policies for sustainable growth and jobs, in particular a Union strategy for growth and jobs, with particular focus on developing and strengthening the internal market, fostering international trade and competitiveness, a European Semester for strengthened coordination of economic and budgetary policies, an effective framework for preventing and correcting excessive government deficits (the Stability and Growth Pact (SGP)), a robust framework for preventing and correcting macroeconomic imbalances, minimum requirements for national budgetary frameworks, and enhanced financial market regulation and supervision, including macroprudential supervision by the European Systemic Risk Board. (5) The SGP and the complete economic governance framework should complement and be compatible with the Union strategy for growth and jobs. The interlinks between different strands should not provide for exemptions from the provisions of the SGP. (6) Achieving and maintaining a dynamic internal market should be considered an element of the proper and smooth functioning of the economic and monetary union. (7) The Commission should play a stronger role in the enhanced surveillance procedure as regards assessments that are specific to each Member State, monitoring, on-site missions, recommendations and warnings. When taking decisions on sanctions, the role of the Council should be limited, and reversed qualified majority voting should be used. (8) In order to ensure a permanent dialogue with the Member States aiming at achieving the objectives of this Regulation, the Commission should carry out surveillance missions. (9) A broad evaluation of the economic governance system, in particular of the effectiveness and adequacy of its sanctions, should be undertaken by the Commission at regular intervals. Such evaluations should be complemented by relevant proposals if necessary. (10) When implementing this Regulation, the Commission should take into account the current economic situation of the Member States concerned. (11) The strengthening of economic governance should include a closer and a more timely involvement of the European Parliament and the national parliaments. (12) An economic dialogue with the European Parliament may be established, enabling the Commission to make its analyses public and the President of the Council, the Commission and, where appropriate, the President of the European Council or the President of the Eurogroup to discuss. Such a public debate could enable discussion of the spill-over effects of national decisions and enable public peer pressure to be brought to bear on the relevant actors. While recognising that the counterparts of the European Parliament in the framework of that dialogue are the relevant institutions of the Union and their representatives, the competent committee of the European Parliament may offer an opportunity to participate in an exchange of views to a Member State which is the subject of a Council decision taken pursuant to Articles 4, 5 and 6 of this Regulation. The Member State\u2019s participation in such an exchange of views is voluntary. (13) Additional sanctions are necessary to make the enforcement of budgetary surveillance in the euro area more effective. Those sanctions should enhance the credibility of the fiscal surveillance framework of the Union. (14) The rules laid down in this Regulation should ensure fair, timely, graduated and effective mechanisms for compliance with the preventive and the corrective parts of the SGP, in particular Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (4) and Council Regulation (EC) No 1467/97 of 7 July 1997 on speeding up and clarifying the implementation of the excessive deficit procedure (5), where compliance with the budgetary discipline is examined on the basis of the government deficit and government debt criteria. (15) Sanctions under this Regulation and based upon the preventive part of the SGP in respect of Member States whose currency is the euro should provide incentives for adjusting to and maintaining the medium-term budgetary objective. (16) In order to deter against the misrepresentation, whether intentional or due to serious negligence, of government deficit and debt data, which data is an essential input to economic policy coordination in the Union, fines should be imposed on Member States responsible. (17) In order to supplement the rules on calculation of the fines for manipulation of statistics as well as the rules on the procedure to be followed by the Commission for the investigation of such actions, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of detailed criteria for establishing the amount of the fine and for conducting the Commission\u2019s investigations. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. (18) In respect of the preventive part of the SGP, adjustment and adherence to the medium-term budgetary objective should be ensured through an obligation imposed on a Member State whose currency is the euro that is making insufficient progress with budgetary consolidation to lodge temporarily an interest-bearing deposit. This should be the case when a Member State, including a Member State with a deficit below the 3 % of Gross Domestic Product (GDP) reference value, deviates significantly from the medium-term budgetary objective or the appropriate adjustment path towards that objective and fails to correct the deviation. (19) The interest-bearing deposit imposed should be released to the Member State concerned together with the interest accrued on it once the Council has been satisfied that the situation giving rise to the obligation to lodge that deposit has come to an end. (20) In respect of the corrective part of the SGP, sanctions for Member States whose currency is the euro should take the form of an obligation to lodge a non-interest-bearing deposit linked to a Council decision establishing the existence of an excessive deficit if an interest-bearing deposit has already been imposed on the Member State concerned in the preventive part of the SGP or in cases of particularly serious non-compliance with the budgetary policy obligations laid down in the SGP, or the obligation to pay a fine in the event of non-compliance with a Council recommendation to correct an excessive government deficit. (21) In order to avoid the retroactive application of the sanctions under the preventive part of the SGP provided for in this Regulation, they should apply only in respect of the relevant decisions adopted by the Council under Regulation (EC) No 1466/97 after the entry into force of this Regulation. Similarly, in order to avoid the retroactive application of the sanctions under the corrective part of the SGP provided for in this Regulation, they should apply only in respect of the relevant recommendations and decisions to correct an excessive government deficit adopted by the Council after the entry into force of this Regulation. (22) The amount of the interest-bearing deposits, of the non-interest-bearing deposits and of the fines provided for in this Regulation should be set in such a way as to ensure a fair graduation of sanctions in the preventive and corrective parts of the SGP and to provide sufficient incentives for the Member States whose currency is the euro to comply with the fiscal framework of the Union. Fines under Article 126(11) TFEU and as specified in Article 12 of Regulation (EC) No 1467/97 are composed of a fixed component that equals 0,2 % of GDP and of a variable component. Thus, graduation and equal treatment between Member States are ensured if the interest-bearing deposit, the non-interest-bearing deposit and the fine specified in this Regulation are equal to 0,2 % of GDP, that being the amount of the fixed component of the fine under Article 126(11) TFEU. (23) A possibility should be provided for the Council to reduce or to cancel the sanctions imposed on Member States whose currency is the euro on the basis of a Commission recommendation following a reasoned request by the Member State concerned. In the corrective part of the SGP, the Commission should also be able to recommend reducing the amount of a sanction or cancelling it on grounds of exceptional economic circumstances. (24) The non-interest-bearing deposit should be released upon correction of the excessive deficit, while the interest on such deposits and the fines collected should be assigned to stability mechanisms to provide financial assistance, created by Member States whose currency is the euro in order to safeguard the stability of the euro area as a whole. (25) The power to adopt individual decisions for the application of the sanctions provided for in this Regulation should be conferred on the Council. As part of the coordination of the economic policies of the Member States conducted within the Council as provided for in Article 121(1) TFEU, those individual decisions are an integral follow-up to the measures adopted by the Council in accordance with Articles 121 and 126 TFEU and Regulations (EC) No 1466/97 and (EC) No 1467/97. (26) Since this Regulation contains general rules for the effective enforcement of Regulations (EC) No 1466/97 and (EC) No 1467/97, it should be adopted in accordance with the ordinary legislative procedure referred to in Article 121(6) TFEU. (27) Since the objective of this Regulation, namely to create a system of sanctions for enhancing the enforcement of the preventive and corrective parts of the SGP in the euro area, cannot be sufficiently achieved at the level of the Member States, the Union may adopt measures in accordance with the principles of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter and scope 1. This Regulation sets out a system of sanctions for enhancing the enforcement of the preventive and corrective parts of the Stability and Growth Pact in the euro area. 2. This Regulation shall apply to Member States whose currency is the euro. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018preventive part of the Stability and Growth Pact\u2019 means the multilateral surveillance system as organised by Regulation (EC) No 1466/97; (2) \u2018corrective part of the Stability and Growth Pact\u2019 means the procedure for the avoidance of Member States\u2019 excessive deficit as regulated by Article 126 TFEU and Regulation (EC) No 1467/97; (3) \u2018exceptional economic circumstances\u2019 means circumstances where an excess of a government deficit over the reference value is considered exceptional within the meaning of the second indent of point (a) of Article 126(2) TFEU and as specified in Regulation (EC) No 1467/97. CHAPTER II ECONOMIC DIALOGUE Article 3 Economic dialogue In order to enhance the dialogue between the institutions of the Union, in particular the European Parliament, the Council and the Commission, and to ensure greater transparency and accountability, the competent committee of the European Parliament may invite the President of the Council, the Commission and, where appropriate, the President of the European Council or the President of the Eurogroup to appear before the committee to discuss decisions taken pursuant to Articles 4, 5 and 6 of this Regulation. The competent committee of the European Parliament may offer the opportunity to the Member State concerned by such decisions to participate in an exchange of views. CHAPTER III SANCTIONS IN THE PREVENTIVE PART OF THE STABILITY AND GROWTH PACT Article 4 Interest-bearing deposits 1. If the Council adopts a decision establishing that a Member State failed to take action in response to the Council recommendation referred to in the second subparagraph of Article 6(2) of Regulation (EC) No 1466/97, the Commission shall, within 20 days of adoption of the Council\u2019s decision, recommend that the Council, by a further decision, require the Member State in question to lodge with the Commission an interest-bearing deposit amounting to 0,2 % of its GDP in the preceding year. 2. The decision requiring a lodgement shall be deemed to be adopted by the Council unless it decides by a qualified majority to reject the Commission\u2019s recommendation within 10 days of the Commission\u2019s adoption thereof. 3. The Council, acting by a qualified majority, may amend the Commission\u2019s recommendation and adopt the text so amended as a Council decision. 4. The Commission may, following a reasoned request by the Member State concerned addressed to the Commission within 10 days of adoption of the Council\u2019s decision establishing that a Member State failed to take action referred to in paragraph 1, recommend that the Council reduce the amount of the interest-bearing deposit or cancel it. 5. The interest-bearing deposit shall bear an interest rate reflecting the Commission\u2019s credit risk and the relevant investment period. 6. If the situation giving rise to the Council\u2019s recommendation referred to in the second subparagraph of Article 6(2) of Regulation (EC) No 1466/97 no longer exists, the Council, on the basis of a further recommendation from the Commission, shall decide that the deposit and the interest accrued thereon be returned to the Member State concerned. The Council may, acting by a qualified majority, amend the Commission\u2019s further recommendation. CHAPTER IV SANCTIONS IN THE CORRECTIVE PART OF THE STABILITY AND GROWTH PACT Article 5 Non-interest-bearing deposits 1. If the Council, acting under Article 126(6) TFEU, decides that an excessive deficit exists in a Member State which has lodged an interest-bearing deposit with the Commission in accordance with Article 4(1) of this Regulation, or where the Commission has identified particularly serious non-compliance with the budgetary policy obligations laid down in the SGP, the Commission shall, within 20 days of adoption of the Council\u2019s decision, recommend that the Council, by a further decision, require the Member State concerned to lodge with the Commission a non-interest-bearing deposit amounting to 0,2 % of its GDP in the preceding year. 2. The decision requiring a lodgement shall be deemed to be adopted by the Council unless it decides by a qualified majority to reject the Commission\u2019s recommendation within 10 days of the Commission\u2019s adoption thereof. 3. The Council, acting by a qualified majority, may amend the Commission\u2019s recommendation and adopt the text so amended as a Council decision. 4. The Commission may, on grounds of exceptional economic circumstances or following a reasoned request by the Member State concerned addressed to the Commission within 10 days of adoption of the Council\u2019s decision under Article 126(6) TFEU referred to in paragraph 1, recommend that the Council reduce the amount of the non-interest-bearing deposit or cancel it. 5. The deposit shall be lodged with the Commission. If the Member State has lodged an interest-bearing deposit with the Commission in accordance with Article 4, that interest-bearing deposit shall be converted to a non-interest-bearing deposit. If the amount of an interest-bearing deposit lodged in accordance with Article 4 and of the interest accrued thereon exceeds the amount of the non-interest-bearing deposit to be lodged under paragraph 1 of this Article, the excess shall be returned to the Member State. If the amount of the non-interest-bearing deposit exceeds the amount of an interest-bearing deposit lodged in accordance with Article 4 and the interest accrued thereon, the Member State shall make up the shortfall when it lodges the non-interest-bearing deposit. Article 6 Fines 1. If the Council, acting under Article 126(8) TFEU, decides that a Member State has not taken effective action to correct its excessive deficit, the Commission shall, within 20 days of that decision, recommend that the Council, by a further decision, impose a fine, amounting to 0,2 % of the Member State\u2019s GDP in the preceding year. 2. The decision imposing a fine shall be deemed to be adopted by the Council unless it decides by a qualified majority to reject the Commission\u2019s recommendation within 10 days of the Commission\u2019s adoption thereof. 3. The Council, acting by a qualified majority, may amend the Commission\u2019s recommendation and adopt the text so amended as a Council decision. 4. The Commission may, on grounds of exceptional economic circumstances or following a reasoned request by the Member State concerned addressed to the Commission within 10 days of adoption of the Council\u2019s decision under Article 126(8) TFEU referred to in paragraph 1, recommend that the Council reduce the amount of the fine or cancel it. 5. If the Member State has lodged a non-interest-bearing deposit with the Commission in accordance with Article 5, the non-interest-bearing deposit shall be converted into the fine. If the amount of a non-interest-bearing deposit lodged in accordance with Article 5 exceeds the amount of the fine, the excess shall be returned to the Member State. If the amount of the fine exceeds the amount of a non-interest-bearing deposit lodged in accordance with Article 5, or if no non-interest-bearing deposit has been lodged, the Member State shall make up the shortfall when it pays the fine Article 7 Return of non-interest-bearing deposits If the Council, acting under Article 126(12) TFEU, decides to abrogate some or all of its decisions, any non-interest-bearing deposit lodged with the Commission shall be returned to the Member State concerned. CHAPTER V SANCTIONS CONCERNING THE MANIPULATION OF STATISTICS Article 8 Sanctions concerning the manipulation of statistics 1. The Council, acting on a recommendation by the Commission, may decide to impose a fine on a Member State that intentionally or by serious negligence misrepresents deficit and debt data relevant for the application of Articles 121 or 126 TFEU, or for the application of the Protocol on the excessive deficit procedure annexed to the TEU and to the TFEU. 2. The fines referred to in paragraph 1 shall be effective, dissuasive and proportionate to the nature, seriousness and duration of the misrepresentation. The amount of the fine shall not exceed 0,2 % of GDP of the Member State concerned. 3. The Commission may conduct all investigations necessary to establish the existence of the misrepresentations referred to in paragraph 1. It may decide to initiate an investigation when it finds that there are serious indications of the existence of facts liable to constitute such a misrepresentation. The Commission shall investigate the putative misrepresentations taking into account any comments submitted by the Member State concerned. In order to carry out its tasks, the Commission may request the Member State to provide information, and may conduct on-site inspections and accede to the accounts of all government entities at central, state, local and social-security level. If the law of the Member State concerned requires prior judicial authorisation for on-site inspections, the Commission shall make the necessary applications. Upon completion of its investigation, and before submitting any proposal to the Council, the Commission shall give to the Member State concerned the opportunity of being heard in relation to the matters under investigation. The Commission shall base any proposal to the Council only on facts on which the Member State concerned has had the opportunity to comment. The Commission shall fully respect the rights of defence of the Member State concerned during the investigations. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 11 concerning: (a) detailed criteria establishing the amount of the fine referred to in paragraph 1; (b) detailed rules concerning the procedures for the investigations referred to in paragraph 3, the associated measures and the reporting on the investigations; (c) detailed rules of procedure aimed at guaranteeing the rights of the defence, access to the file, legal representation, confidentiality and provisions as to timing and the collection of the fines referred to in paragraph 1. 5. The Court of Justice of the European Union shall have unlimited jurisdiction to review the decisions of the Council imposing fines under paragraph 1. It may annul, reduce or increase the fine so imposed. CHAPTER VI ADMINISTRATIVE NATURE OF THE SANCTIONS AND DISTRIBUTION OF THE INTEREST AND FINES Article 9 Administrative nature of the sanctions The sanctions imposed pursuant to Articles 4 to 8 shall be of an administrative nature. Article 10 Distribution of the interest and fines The interest earned by the Commission on deposits lodged in accordance with Article 5 and the fines collected in accordance with Articles 6 and 8 shall constitute other revenue, as referred to in Article 311 TFEU, and shall be assigned to the European Financial Stability Facility. When the Member States whose currency is the euro create another stability mechanism to provide financial assistance in order to safeguard the stability of the euro area as a whole, the interest and the fines shall be assigned to that mechanism. CHAPTER VII GENERAL PROVISIONS Article 11 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 8(4) shall be conferred on the Commission for a period of 3 years from 13 December 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of that 3-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 8(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 8(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 12 Voting in the Council 1. For the measures referred to in Articles 4, 5, 6 and 8, only members of the Council representing Member States whose currency is the euro shall vote, and the Council shall act without taking into account the vote of the member of the Council representing the Member State concerned. 2. A qualified majority of the members of the Council referred to in paragraph 1 shall be defined in accordance with point (b) of Article 238(3) TFEU. Article 13 Review 1. By 14 December 2014 and every 5 years thereafter, the Commission shall publish a report on the application of this Regulation. That report shall evaluate, inter alia: (a) the effectiveness of this Regulation, including the possibility to enable the Council and the Commission to act in order to address situations which risk jeopardising the proper functioning of the monetary union; (b) the progress in ensuring closer coordination of economic policies and sustained convergence of economic performances of the Member States in accordance with the TFEU. 2. Where appropriate, that report shall be accompanied by a proposal for amendments to this Regulation. 3. The report shall be forwarded to the European Parliament and to the Council. 4. Before the end of 2011 the Commission shall present a report to the European Parliament and to the Council on the possibility of introducing euro-securities. Article 14 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 16 November 2011. For the European Parliament The President J. BUZEK For the Council The President W. SZCZUKA (1) OJ C 150, 20.5.2011, p. 1. (2) OJ C 218, 23.7.2011, p. 46. (3) Position of the European Parliament of 28 September 2011 (not yet published in the Official Journal) and decision of the Council of 8 November 2011. (4) OJ L 209, 2.8.1997, p. 1. (5) OJ L 209, 2.8.1997, p. 6.", "summary": "Stability and Growth Pact enforcement Stability and Growth Pact enforcement SUMMARY OF: Regulation (EU) No 1173/2011 \u2014 the effective enforcement of budgetary surveillance in the euro area WHAT IS THE AIM OF THE REGULATION? It sets out a gradual system of sanctions for euro area countries that either fail to comply with the Stability and Growth Pact or manipulate their economic statistics. The rules are mainly designed to encouragegovernments to stick to their medium-term budgetary goals. KEY POINTS Euro area countries which: fail to act toto correct a significant deviation of their structural budget deficit from what is required to achieve their medium-term objective, following a warning from the European Commission, may have to lodge with the Commission an interest-bearing deposit equivalent to 0.2% of their previous year\u2019s gross domestic product (GDP); are deemed to be in excessive deficit by the Council, may have to lodge with the Commission a non-interestbearing deposit equivalent to 0.2% of their previous year\u2019s GDP; do not act effectivelyto correct an excessive deficit, may be fined 0.2% of their previous year\u2019s GDP. The procedures for adopting the abovementioned sanctions are identical. Following a Council decision about the lack of effective action or establishing the existence of an excessive deficit, the Commission proposes the relevant sanction within 20 days. This is adopted unless a qualified majority of euro area countries rejects it. The Commission may recommend the Council reduce or cancel the sanction in the light of exceptional economic circumstances or following the reasoned request by the country concerned. The Council, following a recommendation from the Commission, may also fine a euro area country up to 0.2% of its GDP if it intentionally, or by serious negligence, misrepresents its deficit and debt data. Income generated from fines and non-interest-bearing deposits is transferred to the European Stability Mechanism to help euro area members requiring financial assistance. The Commission, publishes a report every 5 years, starting from 14 December 2014, evaluating the: effectiveness of this regulation in tackling potential risks to the proper functioning of the monetary union; progress made in ensuring closer coordination and convergence of national economic policies and performance. FROM WHEN DOES THE REGULATION APPLY? It has applied since 13 December 2011. BACKGROUND The regulation is one of 6 pieces of legislation (known as the Six-pack) designed to strengthen economic governance in the EU, and more specifically, in the euro area. The others are: a regulation amending Regulation (EC) No 1466/97 on the surveillance of national budgets and economic policies; a regulation amending Regulation (EC) No 1467/97 on the EU\u2019s excessive deficit procedure; a regulation on the prevention and correction of macroeconomic imbalances; a regulation on enforcement measures to correct excessive macroeconomic imbalances in the euro area; and a directive on requirements for national budgets of euro countries. For more information, see: EU economic governance \u2018Six-Pack\u2019 enters into force \u2014 press release (European Commission). MAIN DOCUMENT Regulation (EU) No 1173/2011 of the European Parliament and of the Council of 16 November 2011 on the effective enforcement of budgetary surveillance in the euro area (OJ L 306, 23.11.2011, pp. 1-7) RELATED DOCUMENTS Regulation (EU) No 1174/2011 of the European Parliament and of the Council of 16 November 2011 on enforcement measures to correct excessive macroeconomic imbalances in the euro area (OJ L 306, 23.11.2011, pp. 8-11) Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances (OJ L 306, 23.11.2011, pp. 25-32) Council Directive 2011/85/EU of 8 November 2011 on requirements for budgetary frameworks of the Member States (OJ L 306, 23.11.2011, pp. 41-47) Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (OJ L 209, 2.8.1997, pp. 1-5) Successive amendments to Regulation (EC) No 1466/97 have been incorporated into the original document. This consolidated version is of documentary value only. Council Regulation (EC) No 1467/97 of 7 July 1997 on speeding up and clarifying the implementation of the excessive deficit procedure (OJ L 209, 2.8.1997, pp. 6-11) See consolidated version. last update 06.12.2017"}
{"article": "15.9.2009 EN Official Journal of the European Union L 243/1 REGULATION (EC) No 810/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 July 2009 establishing a Community Code on Visas (Visa Code) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 62(2)(a) and (b)(ii) thereof, Having regard to the proposal from the Commission, Acting in accordance with the procedure laid down in Article 251 of the Treaty (1), Whereas: (1) In accordance with Article 61 of the Treaty, the creation of an area in which persons may move freely should be accompanied by measures with respect to external border controls, asylum and immigration. (2) Pursuant to Article 62(2) of the Treaty, measures on the crossing of the external borders of the Member States shall establish rules on visas for intended stays of no more than three months, including the procedures and conditions for issuing visas by Member States. (3) As regards visa policy, the establishment of a \u2018common corpus\u2019 of legislation, particularly via the consolidation and development of the acquis (the relevant provisions of the Convention implementing the Schengen Agreement of 14 June 1985 (2) and the Common Consular Instructions (3), is one of the fundamental components of \u2018further development of the common visa policy as part of a multi-layer system aimed at facilitating legitimate travel and tackling illegal immigration through further harmonisation of national legislation and handling practices at local consular missions\u2019, as defined in the Hague Programme: strengthening freedom, security and justice in the European Union (4). (4) Member States should be present or represented for visa purposes in all third countries whose nationals are subject to visa requirements. Member States lacking their own consulate in a given third country or in a certain part of a given third country should endeavour to conclude representation arrangements in order to avoid a disproportionate effort on the part of visa applicants to have access to consulates. (5) It is necessary to set out rules on the transit through international areas of airports in order to combat illegal immigration. Thus nationals from a common list of third countries should be required to hold airport transit visas. Nevertheless, in urgent cases of mass influx of illegal immigrants, Member States should be allowed to impose such a requirement on nationals of third countries other than those listed in the common list. Member States\u2019 individual decisions should be reviewed on an annual basis. (6) The reception arrangements for applicants should be made with due respect for human dignity. Processing of visa applications should be conducted in a professional and respectful manner and be proportionate to the objectives pursued. (7) Member States should ensure that the quality of the service offered to the public is of a high standard and follows good administrative practices. They should allocate appropriate numbers of trained staff as well as sufficient resources in order to facilitate as much as possible the visa application process. Member States should ensure that a \u2018one-stop\u2019 principle is applied to all applicants. (8) Provided that certain conditions are fulfilled, multiple-entry visas should be issued in order to lessen the administrative burden of Member States\u2019 consulates and to facilitate smooth travel for frequent or regular travellers. Applicants known to the consulate for their integrity and reliability should as far as possible benefit from a simplified procedure. (9) Because of the registration of biometric identifiers in the Visa Information System (VIS) as established by Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (VIS Regulation) (5), the appearance of the applicant in person \u2014 at least for the first application \u2014 should be one of the basic requirements for the application for a visa. (10) In order to facilitate the visa application procedure of any subsequent application, it should be possible to copy fingerprints from the first entry into the VIS within a period of 59 months. Once this period of time has elapsed, the fingerprints should be collected again. (11) Any document, data or biometric identifier received by a Member State in the course of the visa application process shall be considered a consular document under the Vienna Convention on Consular Relations of 24 April 1963 and shall be treated in an appropriate manner. (12) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (6) applies to the Member States with regard to the processing of personal data pursuant to this Regulation. (13) In order to facilitate the procedure, several forms of cooperation should be envisaged, such as limited representation, co-location, common application centres, recourse to honorary consuls and cooperation with external service providers, taking into account in particular data protection requirements set out in Directive 95/46/EC. Member States should, in accordance with the conditions laid down in this Regulation, determine the type of organisational structure which they will use in each third country. (14) It is necessary to make provision for situations in which a Member State decides to cooperate with an external service provider for the collection of applications. Such a decision may be taken if, in particular circumstances or for reasons relating to the local situation, cooperation with other Member States in the form of representation, limited representation, co-location or a Common Application Centre proves not to be appropriate for the Member State concerned. Such arrangements should be established in compliance with the general principles for issuing visas and with the data protection requirements set out in Directive 95/46/EC. In addition, the need to avoid visa shopping should be taken into consideration when establishing and implementing such arrangements. (15) Where a Member State has decided to cooperate with an external service provider, it should maintain the possibility for all applicants to lodge applications directly at its diplomatic missions or consular posts. (16) A Member State should cooperate with an external service provider on the basis of a legal instrument which should contain provisions on its exact responsibilities, on direct and total access to its premises, information for applicants, confidentiality and on the circumstances, conditions and procedures for suspending or terminating the cooperation. (17) This Regulation, by allowing Member States to cooperate with external service providers for the collection of applications while establishing the \u2018one-stop\u2019 principle for the lodging of applications, creates a derogation from the general rule that an applicant must appear in person at a diplomatic mission or consular post. This is without prejudice to the possibility of calling the applicant for a personal interview. (18) Local Schengen cooperation is crucial for the harmonised application of the common visa policy and for proper assessment of migratory and/or security risks. Given the differences in local circumstances, the operational application of particular legislative provisions should be assessed among Member States\u2019 diplomatic missions and consular posts in individual locations in order to ensure a harmonised application of the legislative provisions to prevent visa shopping and different treatment of visa applicants. (19) Statistical data are an important means of monitoring migratory movements and can serve as an efficient management tool. Therefore, such data should be compiled regularly in a common format. (20) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7). (21) In particular, the Commission should be empowered to adopt amendments to the Annexes to this Regulation. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (22) In order to ensure the harmonised application of this Regulation at operational level, instructions should be drawn up on the practice and procedures to be followed by Member States when processing visa applications. (23) A common Schengen visa Internet site is to be established to improve the visibility and a uniform image of the common visa policy. Such a site will serve as a means to provide the general public with all relevant information in relation to the application for a visa. (24) Appropriate measures should be adopted for the monitoring and evaluation of this Regulation. (25) The VIS Regulation and Regulation (EC) No 562/2006 of the European Parliament and of the Council of 15 March 2006 establishing a Community Code on the rules governing the movement of persons across borders (Schengen Borders Code) (8) should be amended in order to take account of the provisions of this Regulation. (26) Bilateral agreements concluded between the Community and third countries aiming at facilitating the processing of applications for visas may derogate from the provisions of this Regulation. (27) When a Member State hosts the Olympic Games and the Paralympic Games, a particular scheme facilitating the issuing of visas to members of the Olympic family should apply. (28) Since the objective of this Regulation, namely the establishment of the procedures and conditions for issuing visas for transit through or intended stays in the territory of the Member States not exceeding three months in any six-month period, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (29) This Regulation respects fundamental rights and observes the principles recognised in particular by the Council of Europe\u2019s Convention for the Protection of Human Rights and Fundamental Freedoms and by the Charter of Fundamental Rights of the European Union. (30) The conditions governing entry into the territory of the Member States or the issue of visas do not affect the rules currently governing recognition of the validity of travel documents. (31) In accordance with Articles 1 and 2 of the Protocol on the Position of Denmark annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark does not take part in the adoption of this Regulation and is not bound by it, or subject to its application. Given that this Regulation builds on the Schengen acquis under the provisions of Title IV of Part Three of the Treaty establishing the European Community, Denmark shall, in accordance with Article 5 of that Protocol, decide within a period of six months after the date of adoption of this Regulation whether it will implement it in its national law. (32) As regards Iceland and Norway, this Regulation constitutes a development of provisions of the Schengen acquis within the meaning of the Agreement concluded between the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (9) which fall within the area referred to in Article 1, point B of Council Decision 1999/437/EC (10) on certain arrangements for the application of that Agreement. (33) An arrangement should be made to allow representatives of Iceland and Norway to be associated with the work of committees assisting the Commission in the exercise of its implementing powers under this Regulation. Such an arrangement has been contemplated in the Exchange of Letters between the Council of the European Union and Iceland and Norway concerning committees which assist the European Commission in the exercise of its executive powers (11), annexed to the abovementioned Agreement. The Commission has submitted to the Council a draft recommendation with a view to negotiating this arrangement. (34) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (12), which fall within the area referred to in Article 1, point B, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (13) on the conclusion of that Agreement. (35) As regards Liechtenstein, this Regulation constitutes a development of provisions of the Schengen acquis within the meaning of the Protocol signed between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement concluded between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis, which fall within the area referred to in Article 1, point B, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/261/EC (14) on the signing of that Protocol. (36) This Regulation constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (15). The United Kingdom is therefore not taking part in its adoption and is not bound by it or subject to its application. (37) This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC of 28 February 2002 concerning Ireland\u2019s request to take part in some of the provisions of the Schengen acquis (16). Ireland is therefore not taking part in the adoption of the Regulation and is not bound by it or subject to its application. (38) This Regulation, with the exception of Article 3, constitutes provisions building on the Schengen acquis or otherwise relating to it within the meaning of Article 3(2) of the 2003 Act of Accession and within the meaning of Article 4(2) of the 2005 Act of Accession, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Objective and scope 1. This Regulation establishes the procedures and conditions for issuing visas for transit through or intended stays in the territory of the Member States not exceeding three months in any six-month period. 2. The provisions of this Regulation shall apply to any third-country national who must be in possession of a visa when crossing the external borders of the Member States pursuant to Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (17), without prejudice to: (a) the rights of free movement enjoyed by third-country nationals who are family members of citizens of the Union; (b) the equivalent rights enjoyed by third-country nationals and their family members, who, under agreements between the Community and its Member States, on the one hand, and these third countries, on the other, enjoy rights of free movement equivalent to those of Union citizens and members of their families. 3. This Regulation also lists the third countries whose nationals are required to hold an airport transit visa by way of exception from the principle of free transit laid down in Annex 9 to the Chicago Convention on International Civil Aviation, and establishes the procedures and conditions for issuing visas for the purpose of transit through the international transit areas of Member States\u2019 airports. Article 2 Definitions For the purpose of this Regulation the following definitions shall apply: 1. \u2018third-country national\u2019 means any person who is not a citizen of the Union within the meaning of Article 17(1) of the Treaty; 2. \u2018visa\u2019 means an authorisation issued by a Member State with a view to: (a) transit through or an intended stay in the territory of the Member States of a duration of no more than three months in any six-month period from the date of first entry in the territory of the Member States; (b) transit through the international transit areas of airports of the Member States; 3. \u2018uniform visa\u2019 means a visa valid for the entire territory of the Member States; 4. \u2018visa with limited territorial validity\u2019 means a visa valid for the territory of one or more Member States but not all Member States; 5. \u2018airport transit visa\u2019 means a visa valid for transit through the international transit areas of one or more airports of the Member States; 6. \u2018visa sticker\u2019 means the uniform format for visas as defined by Council Regulation (EC) No 1683/95 of 29 May 1995 laying down a uniform format for visas (18); 7. \u2018recognised travel document\u2019 means a travel document recognised by one or more Member States for the purpose of affixing visas; 8. \u2018separate sheet for affixing a visa\u2019 means the uniform format for forms for affixing the visa issued by Member States to persons holding travel documents not recognised by the Member State drawing up the form as defined by Council Regulation (EC) No 333/2002 of 18 February 2002 on a uniform format for forms for affixing the visa issued by Member States to persons holding travel documents not recognised by the Member State drawing up the form (19); 9. \u2018consulate\u2019 means a Member State\u2019s diplomatic mission or a Member State\u2019s consular post authorised to issue visas and headed by a career consular officer as defined by the Vienna Convention on Consular Relations of 24 April 1963; 10. \u2018application\u2019 means an application for a visa; 11. \u2018commercial intermediary\u2019 means a private administrative agency, transport company or travel agency (tour operator or retailer). TITLE II AIRPORT TRANSIT VISA Article 3 Third-country nationals required to hold an airport transit visa 1. Nationals of the third countries listed in Annex IV shall be required to hold an airport transit visa when passing through the international transit areas of airports situated on the territory of the Member States. 2. In urgent cases of mass influx of illegal immigrants, individual Member States may require nationals of third countries other than those referred to in paragraph 1 to hold an airport transit visa when passing through the international transit areas of airports situated on their territory. Member States shall notify the Commission of such decisions before their entry into force and of withdrawals of such an airport transit visa requirement. 3. Within the framework of the Committee referred to in Article 52(1), those notifications shall be reviewed on an annual basis for the purpose of transferring the third country concerned to the list set out in Annex IV. 4. If the third country is not transferred to the list set out in Annex IV, the Member State concerned may maintain, provided that the conditions in paragraph 2 are met, or withdraw the airport transit visa requirement. 5. The following categories of persons shall be exempt from the requirement to hold an airport transit visa provided for in paragraphs 1 and 2: (a) holders of a valid uniform visa, national long-stay visa or residence permit issued by a Member State; (b) third-country nationals holding the valid residence permits listed in Annex V issued by Andorra, Canada, Japan, San Marino or the United States of America guaranteeing the holder\u2019s unconditional readmission; (c) third-country nationals holding a valid visa for a Member State or for a State party to the Agreement on the European Economic Area of 2 May 1992, Canada, Japan or the United States of America, or when they return from those countries after having used the visa; (d) family members of citizens of the Union as referred to in Article 1(2)(a); (e) holders of diplomatic passports; (f) flight crew members who are nationals of a contracting Party to the Chicago Convention on International Civil Aviation. TITLE III PROCEDURES AND CONDITIONS FOR ISSUING VISAS CHAPTER I Authorities taking part in the procedures relating to applications Article 4 Authorities competent for taking part in the procedures relating to applications 1. Applications shall be examined and decided on by consulates. 2. By way of derogation from paragraph 1, applications may be examined and decided on at the external borders of the Member States by the authorities responsible for checks on persons, in accordance with Articles 35 and 36. 3. In the non-European overseas territories of Member States, applications may be examined and decided on by the authorities designated by the Member State concerned. 4. A Member State may require the involvement of authorities other than the ones designated in paragraphs 1 and 2 in the examination of and decision on applications. 5. A Member State may require to be consulted or informed by another Member State in accordance with Articles 22 and 31. Article 5 Member State competent for examining and deciding on an application 1. The Member State competent for examining and deciding on an application for a uniform visa shall be: (a) the Member State whose territory constitutes the sole destination of the visit(s); (b) if the visit includes more than one destination, the Member State whose territory constitutes the main destination of the visit(s) in terms of the length or purpose of stay; or (c) if no main destination can be determined, the Member State whose external border the applicant intends to cross in order to enter the territory of the Member States. 2. The Member State competent for examining and deciding on an application for a uniform visa for the purpose of transit shall be: (a) in the case of transit through only one Member State, the Member State concerned; or (b) in the case of transit through several Member States, the Member State whose external border the applicant intends to cross to start the transit. 3. The Member State competent for examining and deciding on an application for an airport transit visa shall be: (a) in the case of a single airport transit, the Member State on whose territory the transit airport is situated; or (b) in the case of double or multiple airport transit, the Member State on whose territory the first transit airport is situated. 4. Member States shall cooperate to prevent a situation in which an application cannot be examined and decided on because the Member State that is competent in accordance with paragraphs 1 to 3 is neither present nor represented in the third country where the applicant lodges the application in accordance with Article 6. Article 6 Consular territorial competence 1. An application shall be examined and decided on by the consulate of the competent Member State in whose jurisdiction the applicant legally resides. 2. A consulate of the competent Member State shall examine and decide on an application lodged by a third-country national legally present but not residing in its jurisdiction, if the applicant has provided justification for lodging the application at that consulate. Article 7 Competence to issue visas to third-country nationals legally present within the territory of a Member State Third-country nationals who are legally present in the territory of a Member State and who are required to hold a visa to enter the territory of one or more other Member States shall apply for a visa at the consulate of the Member State that is competent in accordance with Article 5(1) or (2). Article 8 Representation arrangements 1. A Member State may agree to represent another Member State that is competent in accordance with Article 5 for the purpose of examining applications and issuing visas on behalf of that Member State. A Member State may also represent another Member State in a limited manner solely for the collection of applications and the enrolment of biometric identifiers. 2. The consulate of the representing Member State shall, when contemplating refusing a visa, submit the application to the relevant authorities of the represented Member State in order for them to take the final decision on the application within the time limits set out in Article 23(1), (2) or (3). 3. The collection and transmission of files and data to the represented Member State shall be carried out in compliance with the relevant data protection and security rules. 4. A bilateral arrangement shall be established between the representing Member State and the represented Member State containing the following elements: (a) it shall specify the duration of such representation, if only temporary, and procedures for its termination; (b) it may, in particular when the represented Member State has a consulate in the third country concerned, provide for the provision of premises, staff and payments by the represented Member State; (c) it may stipulate that applications from certain categories of third-country nationals are to be transmitted by the representing Member State to the central authorities of the represented Member State for prior consultation as provided for in Article 22; (d) by way of derogation from paragraph 2, it may authorise the consulate of the representing Member State to refuse to issue a visa after examination of the application. 5. Member States lacking their own consulate in a third country shall endeavour to conclude representation arrangements with Member States that have consulates in that country. 6. With a view to ensuring that a poor transport infrastructure or long distances in a specific region or geographical area does not require a disproportionate effort on the part of applicants to have access to a consulate, Member States lacking their own consulate in that region or area shall endeavour to conclude representation arrangements with Member States that have consulates in that region or area. 7. The represented Member State shall notify the representation arrangements or the termination of such arrangements to the Commission before they enter into force or are terminated. 8. Simultaneously, the consulate of the representing Member State shall inform both the consulates of other Member States and the delegation of the Commission in the jurisdiction concerned about representation arrangements or the termination of such arrangements before they enter into force or are terminated. 9. If the consulate of the representing Member State decides to cooperate with an external service provider in accordance with Article 43, or with accredited commercial intermediaries as provided for in Article 45, such cooperation shall include applications covered by representation arrangements. The central authorities of the represented Member State shall be informed in advance of the terms of such cooperation. CHAPTER II Application Article 9 Practical modalities for lodging an application 1. Applications shall be lodged no more than three months before the start of the intended visit. Holders of a multiple-entry visa may lodge the application before the expiry of the visa valid for a period of at least six months. 2. Applicants may be required to obtain an appointment for the lodging of an application. The appointment shall, as a rule, take place within a period of two weeks from the date when the appointment was requested. 3. In justified cases of urgency, the consulate may allow applicants to lodge their applications either without appointment, or an appointment shall be given immediately. 4. Applications may be lodged at the consulate by the applicant or by accredited commercial intermediaries, as provided for in Article 45(1), without prejudice to Article 13, or in accordance with Article 42 or 43. Article 10 General rules for lodging an application 1. Without prejudice to the provisions of Articles 13, 42, 43 and 45, applicants shall appear in person when lodging an application. 2. Consulates may waive the requirement referred to in paragraph 1 when the applicant is known to them for his integrity and reliability. 3. When lodging the application, the applicant shall: (a) present an application form in accordance with Article 11; (b) present a travel document in accordance with Article 12; (c) present a photograph in accordance with the standards set out in Regulation (EC) No 1683/95 or, where the VIS is operational pursuant to Article 48 of the VIS Regulation, in accordance with the standards set out in Article 13 of this Regulation; (d) allow the collection of his fingerprints in accordance with Article 13, where applicable; (e) pay the visa fee in accordance with Article 16; (f) provide supporting documents in accordance with Article 14 and Annex II; (g) where applicable, produce proof of possession of adequate and valid travel medical insurance in accordance with Article 15. Article 11 Application form 1. Each applicant shall submit a completed and signed application form, as set out in Annex I. Persons included in the applicant\u2019s travel document shall submit a separate application form. Minors shall submit an application form signed by a person exercising permanent or temporary parental authority or legal guardianship. 2. Consulates shall make the application form widely available and easily accessible to applicants free of charge. 3. The form shall be available in the following languages: (a) the official language(s) of the Member State for which a visa is requested; (b) the official language(s) of the host country; (c) the official language(s) of the host country and the official language(s) of the Member State for which a visa is requested; or (d) in case of representation, the official language(s) of the representing Member State. In addition to the language(s) referred to in point (a), the form may be made available in another official language of the institutions of the European Union. 4. If the application form is not available in the official language(s) of the host country, a translation of it into that/those language(s) shall be made available separately to applicants. 5. A translation of the application form into the official language(s) of the host country shall be produced under local Schengen cooperation provided for in Article 48. 6. The consulate shall inform applicants of the language(s) which may be used when filling in the application form. Article 12 Travel document The applicant shall present a valid travel document satisfying the following criteria: (a) its validity shall extend at least three months after the intended date of departure from the territory of the Member States or, in the case of several visits, after the last intended date of departure from the territory of the Member States. However, in a justified case of emergency, this obligation may be waived; (b) it shall contain at least two blank pages; (c) it shall have been issued within the previous 10 years. Article 13 Biometric identifiers 1. Member States shall collect biometric identifiers of the applicant comprising a photograph of him and his 10 fingerprints in accordance with the safeguards laid down in the Council of Europe\u2019s Convention for the Protection of Human Rights and Fundamental Freedoms, in the Charter of Fundamental Rights of the European Union and in the United Nations Convention on the Rights of the Child. 2. At the time of submission of the first application, the applicant shall be required to appear in person. At that time, the following biometric identifiers of the applicant shall be collected: \u2014 a photograph, scanned or taken at the time of application, and \u2014 his 10 fingerprints taken flat and collected digitally. 3. Where fingerprints collected from the applicant as part of an earlier application were entered in the VIS for the first time less than 59 months before the date of the new application, they shall be copied to the subsequent application. However, where there is reasonable doubt regarding the identity of the applicant, the consulate shall collect fingerprints within the period specified in the first subparagraph. Furthermore, if at the time when the application is lodged, it cannot be immediately confirmed that the fingerprints were collected within the period specified in the first subparagraph, the applicant may request that they be collected. 4. In accordance with Article 9(5) of the VIS Regulation, the photograph attached to each application shall be entered in the VIS. The applicant shall not be required to appear in person for this purpose. The technical requirements for the photograph shall be in accordance with the international standards as set out in the International Civil Aviation Organization (ICAO) document 9303 Part 1, 6th edition. 5. Fingerprints shall be taken in accordance with ICAO standards and Commission Decision 2006/648/EC of 22 September 2006 laying down the technical specifications on the standards for biometric features related to the development of the Visa Information System (20). 6. The biometric identifiers shall be collected by qualified and duly authorised staff of the authorities competent in accordance with Article 4(1), (2) and (3). Under the supervision of the consulates, the biometric identifiers may also be collected by qualified and duly authorised staff of an honorary consul as referred to in Article 42 or of an external service provider as referred to in Article 43. The Member State(s) concerned shall, where there is any doubt, provide for the possibility of verifying at the consulate fingerprints which have been taken by the external service provider. 7. The following applicants shall be exempt from the requirement to give fingerprints: (a) children under the age of 12; (b) persons for whom fingerprinting is physically impossible. If the fingerprinting of fewer than 10 fingers is possible, the maximum number of fingerprints shall be taken. However, should the impossibility be temporary, the applicant shall be required to give the fingerprints at the following application. The authorities competent in accordance with Article 4(1), (2) and (3) shall be entitled to ask for further clarification of the grounds for the temporary impossibility. Member States shall ensure that appropriate procedures guaranteeing the dignity of the applicant are in place in the event of there being difficulties in enrolling; (c) heads of State or government and members of a national government with accompanying spouses, and the members of their official delegation when they are invited by Member States\u2019 governments or by international organisations for an official purpose; (d) sovereigns and other senior members of a royal family, when they are invited by Member States\u2019 governments or by international organisations for an official purpose. 8. In the cases referred to in paragraph 7, the entry \u2018not applicable\u2019 shall be introduced in the VIS in accordance with Article 8(5) of the VIS Regulation. Article 14 Supporting documents 1. When applying for a uniform visa, the applicant shall present: (a) documents indicating the purpose of the journey; (b) documents in relation to accommodation, or proof of sufficient means to cover his accommodation; (c) documents indicating that the applicant possesses sufficient means of subsistence both for the duration of the intended stay and for the return to his country of origin or residence, or for the transit to a third country into which he is certain to be admitted, or that he is in a position to acquire such means lawfully, in accordance with Article 5(1)(c) and (3) of the Schengen Borders Code; (d) information enabling an assessment of the applicant\u2019s intention to leave the territory of the Member States before the expiry of the visa applied for. 2. When applying for an airport transit visa, the applicant shall present: (a) documents in relation to the onward journey to the final destination after the intended airport transit; (b) information enabling an assessment of the applicant\u2019s intention not to enter the territory of the Member States. 3. A non-exhaustive list of supporting documents which the consulate may request from the applicant in order to verify the fulfilment of the conditions listed in paragraphs 1 and 2 is set out in Annex II. 4. Member States may require applicants to present a proof of sponsorship and/or private accommodation by completing a form drawn up by each Member State. That form shall indicate in particular: (a) whether its purpose is proof of sponsorship and/or of accommodation; (b) whether the host is an individual, a company or an organisation; (c) the host\u2019s identity and contact details; (d) the invited applicant(s); (e) the address of the accommodation; (f) the length and purpose of the stay; (g) possible family ties with the host. In addition to the Member State\u2019s official language(s), the form shall be drawn up in at least one other official language of the institutions of the European Union. The form shall provide the person signing it with the information required pursuant to Article 37(1) of the VIS Regulation. A specimen of the form shall be notified to the Commission. 5. Within local Schengen cooperation the need to complete and harmonise the lists of supporting documents shall be assessed in each jurisdiction in order to take account of local circumstances. 6. Consulates may waive one or more of the requirements of paragraph 1 in the case of an applicant known to them for his integrity and reliability, in particular the lawful use of previous visas, if there is no doubt that he will fulfil the requirements of Article 5(1) of the Schengen Borders Code at the time of the crossing of the external borders of the Member States. Article 15 Travel medical insurance 1. Applicants for a uniform visa for one or two entries shall prove that they are in possession of adequate and valid travel medical insurance to cover any expenses which might arise in connection with repatriation for medical reasons, urgent medical attention and/or emergency hospital treatment or death, during their stay(s) on the territory of the Member States. 2. Applicants for a uniform visa for more than two entries (multiple entries) shall prove that they are in possession of adequate and valid travel medical insurance covering the period of their first intended visit. In addition, such applicants shall sign the statement, set out in the application form, declaring that they are aware of the need to be in possession of travel medical insurance for subsequent stays. 3. The insurance shall be valid throughout the territory of the Member States and cover the entire period of the person\u2019s intended stay or transit. The minimum coverage shall be EUR 30 000. When a visa with limited territorial validity covering the territory of more than one Member State is issued, the insurance cover shall be valid at least in the Member States concerned. 4. Applicants shall, in principle, take out insurance in their country of residence. Where this is not possible, they shall seek to obtain insurance in any other country. When another person takes out insurance in the name of the applicant, the conditions set out in paragraph 3 shall apply. 5. When assessing whether the insurance cover is adequate, consulates shall ascertain whether claims against the insurance company would be recoverable in a Member State. 6. The insurance requirement may be considered to have been met where it is established that an adequate level of insurance may be presumed in the light of the applicant\u2019s professional situation. The exemption from presenting proof of travel medical insurance may concern particular professional groups, such as seafarers, who are already covered by travel medical insurance as a result of their professional activities. 7. Holders of diplomatic passports shall be exempt from the requirement to hold travel medical insurance. Article 16 Visa fee 1. Applicants shall pay a visa fee of EUR 60. 2. Children from the age of six years and below the age of 12 years shall pay a visa fee of EUR 35. 3. The visa fee shall be revised regularly in order to reflect the administrative costs. 4. The visa fee shall be waived for applicants belonging to one of the following categories: (a) children under six years; (b) school pupils, students, postgraduate students and accompanying teachers who undertake stays for the purpose of study or educational training; (c) researchers from third countries travelling for the purpose of carrying out scientific research as defined in Recommendation No 2005/761/EC of the European Parliament and of the Council of 28 September 2005 to facilitate the issue by the Member States of uniform short-stay visas for researchers from third countries travelling within the Community for the purpose of carrying out scientific research (21); (d) representatives of non-profit organisations aged 25 years or less participating in seminars, conferences, sports, cultural or educational events organised by non-profit organisations. 5. The visa fee may be waived for: (a) children from the age of six years and below the age of 12 years; (b) holders of diplomatic and service passports; (c) participants aged 25 years or less in seminars, conferences, sports, cultural or educational events, organised by non-profit organisations. Within local Schengen cooperation, Members States shall aim to harmonise the application of these exemptions. 6. In individual cases, the amount of the visa fee to be charged may be waived or reduced when to do so serves to promote cultural or sporting interests as well as interests in the field of foreign policy, development policy and other areas of vital public interest or for humanitarian reasons. 7. The visa fee shall be charged in euro, in the national currency of the third country or in the currency usually used in the third country where the application is lodged, and shall not be refundable except in the cases referred to in Articles 18(2) and 19(3). When charged in a currency other than euro, the amount of the visa fee charged in that currency shall be determined and regularly reviewed in application of the euro foreign exchange reference rate set by the European Central Bank. The amount charged may be rounded up and consulates shall ensure under local Schengen cooperation that they charge similar fees. 8. The applicant shall be given a receipt for the visa fee paid. Article 17 Service fee 1. An additional service fee may be charged by an external service provider referred to in Article 43. The service fee shall be proportionate to the costs incurred by the external service provider while performing one or more of the tasks referred to in Article 43(6). 2. The service fee shall be specified in the legal instrument referred to in Article 43(2). 3. Within the framework of local Schengen cooperation, Member States shall ensure that the service fee charged to an applicant duly reflects the services offered by the external service provider and is adapted to local circumstances. Furthermore, they shall aim to harmonise the service fee applied. 4. The service fee shall not exceed half of the amount of the visa fee set out in Article 16(1), irrespective of the possible reductions in or exemptions from the visa fee as provided for in Article 16(2), (4), (5) and (6). 5. The Member State(s) concerned shall maintain the possibility for all applicants to lodge their applications directly at its/their consulates. CHAPTER III Examination of and decision on an application Article 18 Verification of consular competence 1. When an application has been lodged, the consulate shall verify whether it is competent to examine and decide on it in accordance with the provisions of Articles 5 and 6. 2. If the consulate is not competent, it shall, without delay, return the application form and any documents submitted by the applicant, reimburse the visa fee, and indicate which consulate is competent. Article 19 Admissibility 1. The competent consulate shall verify whether: \u2014 the application has been lodged within the period referred to in Article 9(1), \u2014 the application contains the items referred to in Article 10(3)(a) to (c), \u2014 the biometric data of the applicant have been collected, and \u2014 the visa fee has been collected. 2. Where the competent consulate finds that the conditions referred to in paragraph 1 have been fulfilled, the application shall be admissible and the consulate shall: \u2014 follow the procedures described in Article 8 of the VIS Regulation, and \u2014 further examine the application. Data shall be entered in the VIS only by duly authorised consular staff in accordance with Articles 6(1), 7, 9(5) and 9(6) of the VIS Regulation. 3. Where the competent consulate finds that the conditions referred to in paragraph 1 have not been fulfilled, the application shall be inadmissible and the consulate shall without delay: \u2014 return the application form and any documents submitted by the applicant, \u2014 destroy the collected biometric data, \u2014 reimburse the visa fee, and \u2014 not examine the application. 4. By way of derogation, an application that does not meet the requirements set out in paragraph 1 may be considered admissible on humanitarian grounds or for reasons of national interest. Article 20 Stamp indicating that an application is admissible 1. When an application is admissible, the competent consulate shall stamp the applicant\u2019s travel document. The stamp shall be as set out in the model in Annex III and shall be affixed in accordance with the provisions of that Annex. 2. Diplomatic, service/official and special passports shall not be stamped. 3. The provisions of this Article shall apply to the consulates of the Member States until the date when the VIS becomes fully operational in all regions, in accordance with Article 48 of the VIS Regulation. Article 21 Verification of entry conditions and risk assessment 1. In the examination of an application for a uniform visa, it shall be ascertained whether the applicant fulfils the entry conditions set out in Article 5(1)(a), (c), (d) and (e) of the Schengen Borders Code, and particular consideration shall be given to assessing whether the applicant presents a risk of illegal immigration or a risk to the security of the Member States and whether the applicant intends to leave the territory of the Member States before the expiry of the visa applied for. 2. In respect of each application, the VIS shall be consulted in accordance with Articles 8(2) and 15 of the VIS Regulation. Member States shall ensure that full use is made of all search criteria pursuant to Article 15 of the VIS Regulation in order to avoid false rejections and identifications. 3. While checking whether the applicant fulfils the entry conditions, the consulate shall verify: (a) that the travel document presented is not false, counterfeit or forged; (b) the applicant\u2019s justification for the purpose and conditions of the intended stay, and that he has sufficient means of subsistence, both for the duration of the intended stay and for the return to his country of origin or residence, or for the transit to a third country into which he is certain to be admitted, or is in a position to acquire such means lawfully; (c) whether the applicant is a person for whom an alert has been issued in the Schengen Information System (SIS) for the purpose of refusing entry; (d) that the applicant is not considered to be a threat to public policy, internal security or public health as defined in Article 2(19) of the Schengen Borders Code or to the international relations of any of the Member States, in particular where no alert has been issued in Member States\u2019 national databases for the purpose of refusing entry on the same grounds; (e) that the applicant is in possession of adequate and valid travel medical insurance, where applicable. 4. The consulate shall, where applicable, verify the length of previous and intended stays in order to verify that the applicant has not exceeded the maximum duration of authorised stay in the territory of the Member States, irrespective of possible stays authorised under a national long-stay visa or a residence permit issued by another Member State. 5. The means of subsistence for the intended stay shall be assessed in accordance with the duration and the purpose of the stay and by reference to average prices in the Member State(s) concerned for board and lodging in budget accommodation, multiplied by the number of days stayed, on the basis of the reference amounts set by the Member States in accordance with Article 34(1)(c) of the Schengen Borders Code. Proof of sponsorship and/or private accommodation may also constitute evidence of sufficient means of subsistence. 6. In the examination of an application for an airport transit visa, the consulate shall in particular verify: (a) that the travel document presented is not false, counterfeit or forged; (b) the points of departure and destination of the third-country national concerned and the coherence of the intended itinerary and airport transit; (c) proof of the onward journey to the final destination. 7. The examination of an application shall be based notably on the authenticity and reliability of the documents submitted and on the veracity and reliability of the statements made by the applicant. 8. During the examination of an application, consulates may in justified cases call the applicant for an interview and request additional documents. 9. A previous visa refusal shall not lead to an automatic refusal of a new application. A new application shall be assessed on the basis of all available information. Article 22 Prior consultation of central authorities of other Member States 1. A Member State may require the central authorities of other Member States to consult its central authorities during the examination of applications lodged by nationals of specific third countries or specific categories of such nationals. Such consultation shall not apply to applications for airport transit visas. 2. The central authorities consulted shall reply definitively within seven calendar days after being consulted. The absence of a reply within this deadline shall mean that they have no grounds for objecting to the issuing of the visa. 3. Member States shall notify the Commission of the introduction or withdrawal of the requirement of prior consultation before it becomes applicable. This information shall also be given within local Schengen cooperation in the jurisdiction concerned. 4. The Commission shall inform Member States of such notifications. 5. From the date of the replacement of the Schengen Consultation Network, as referred to in Article 46 of the VIS Regulation, prior consultation shall be carried out in accordance with Article 16(2) of that Regulation. Article 23 Decision on the application 1. Applications shall be decided on within 15 calendar days of the date of the lodging of an application which is admissible in accordance with Article 19. 2. That period may be extended up to a maximum of 30 calendar days in individual cases, notably when further scrutiny of the application is needed or in cases of representation where the authorities of the represented Member State are consulted. 3. Exceptionally, when additional documentation is needed in specific cases, the period may be extended up to a maximum of 60 calendar days. 4. Unless the application has been withdrawn, a decision shall be taken to: (a) issue a uniform visa in accordance with Article 24; (b) issue a visa with limited territorial validity in accordance with Article 25; (c) refuse a visa in accordance with Article 32; or (d) discontinue the examination of the application and transfer it to the relevant authorities of the represented Member State in accordance with Article 8(2). The fact that fingerprinting is physically impossible, in accordance with Article 13(7)(b), shall not influence the issuing or refusal of a visa. CHAPTER IV Issuing of the visa Article 24 Issuing of a uniform visa 1. The period of validity of a visa and the length of the authorised stay shall be based on the examination conducted in accordance with Article 21. A visa may be issued for one, two or multiple entries. The period of validity shall not exceed five years. In the case of transit, the length of the authorised stay shall correspond to the time necessary for the purpose of the transit. Without prejudice to Article 12(a), the period of validity of the visa shall include an additional \u2018period of grace\u2019 of 15 days. Member States may decide not to grant such a period of grace for reasons of public policy or because of the international relations of any of the Member States. 2. Without prejudice to Article 12(a), multiple-entry visas shall be issued with a period of validity between six months and five years, where the following conditions are met: (a) the applicant proves the need or justifies the intention to travel frequently and/or regularly, in particular due to his occupational or family status, such as business persons, civil servants engaged in regular official contacts with Member States and EU institutions, representatives of civil society organisations travelling for the purpose of educational training, seminars and conferences, family members of citizens of the Union, family members of third-country nationals legally residing in Member States and seafarers; and (b) the applicant proves his integrity and reliability, in particular the lawful use of previous uniform visas or visas with limited territorial validity, his economic situation in the country of origin and his genuine intention to leave the territory of the Member States before the expiry of the visa applied for. 3. The data set out in Article 10(1) of the VIS Regulation shall be entered into the VIS when a decision on issuing such a visa has been taken. Article 25 Issuing of a visa with limited territorial validity 1. A visa with limited territorial validity shall be issued exceptionally, in the following cases: (a) when the Member State concerned considers it necessary on humanitarian grounds, for reasons of national interest or because of international obligations, (i) to derogate from the principle that the entry conditions laid down in Article 5(1)(a), (c), (d) and (e) of the Schengen Borders Code must be fulfilled; (ii) to issue a visa despite an objection by the Member State consulted in accordance with Article 22 to the issuing of a uniform visa; or (iii) to issue a visa for reasons of urgency, although the prior consultation in accordance with Article 22 has not been carried out; or (b) when for reasons deemed justified by the consulate, a new visa is issued for a stay during the same six-month period to an applicant who, over this six-month period, has already used a uniform visa or a visa with limited territorial validity allowing for a stay of three months. 2. A visa with limited territorial validity shall be valid for the territory of the issuing Member State. It may exceptionally be valid for the territory of more than one Member State, subject to the consent of each such Member State. 3. If the applicant holds a travel document that is not recognised by one or more, but not all Member States, a visa valid for the territory of the Member States recognising the travel document shall be issued. If the issuing Member State does not recognise the applicant\u2019s travel document, the visa issued shall only be valid for that Member State. 4. When a visa with limited territorial validity has been issued in the cases described in paragraph 1(a), the central authorities of the issuing Member State shall circulate the relevant information to the central authorities of the other Member States without delay, by means of the procedure referred to in Article 16(3) of the VIS Regulation. 5. The data set out in Article 10(1) of the VIS Regulation shall be entered into the VIS when a decision on issuing such a visa has been taken. Article 26 Issuing of an airport transit visa 1. An airport transit visa shall be valid for transiting through the international transit areas of the airports situated on the territory of Member States. 2. Without prejudice to Article 12(a), the period of validity of the visa shall include an additional \u2018period of grace\u2019 of 15 days. Member States may decide not to grant such a period of grace for reasons of public policy or because of the international relations of any of the Member States. 3. Without prejudice to Article 12(a), multiple airport transit visas may be issued with a period of validity of a maximum six months. 4. The following criteria in particular are relevant for taking the decision to issue multiple airport transit visas: (a) the applicant\u2019s need to transit frequently and/or regularly; and (b) the integrity and reliability of the applicant, in particular the lawful use of previous uniform visas, visas with limited territorial validity or airport transit visas, his economic situation in his country of origin and his genuine intention to pursue his onward journey. 5. If the applicant is required to hold an airport transit visa in accordance with the provisions of Article 3(2), the airport transit visa shall be valid only for transiting through the international transit areas of the airports situated on the territory of the Member State(s) concerned. 6. The data set out in Article 10(1) of the VIS Regulation shall be entered into the VIS when a decision on issuing such a visa has been taken. Article 27 Filling in the visa sticker 1. When the visa sticker is filled in, the mandatory entries set out in Annex VII shall be inserted and the machine-readable zone filled in, as provided for in ICAO document 9303, Part 2. 2. Member States may add national entries in the \u2018comments\u2019 section of the visa sticker, which shall not duplicate the mandatory entries in Annex VII. 3. All entries on the visa sticker shall be printed, and no manual changes shall be made to a printed visa sticker. 4. Visa stickers may be filled in manually only in case of technical force majeure. No changes shall be made to a manually filled in visa sticker. 5. When a visa sticker is filled in manually in accordance with paragraph 4 of this Article, this information shall be entered into the VIS in accordance with Article 10(1)(k) of the VIS Regulation. Article 28 Invalidation of a completed visa sticker 1. If an error is detected on a visa sticker which has not yet been affixed to the travel document, the visa sticker shall be invalidated. 2. If an error is detected after the visa sticker has been affixed to the travel document, the visa sticker shall be invalidated by drawing a cross with indelible ink on the visa sticker and a new visa sticker shall be affixed to a different page. 3. If an error is detected after the relevant data have been introduced into the VIS in accordance with Article 10(1) of the VIS Regulation, the error shall be corrected in accordance with Article 24(1) of that Regulation. Article 29 Affixing a visa sticker 1. The printed visa sticker containing the data provided for in Article 27 and Annex VII shall be affixed to the travel document in accordance with the provisions set out in Annex VIII. 2. Where the issuing Member State does not recognise the applicant\u2019s travel document, the separate sheet for affixing a visa shall be used. 3. When a visa sticker has been affixed to the separate sheet for affixing a visa, this information shall be entered into the VIS in accordance with Article 10(1)(j) of the VIS Regulation. 4. Individual visas issued to persons who are included in the travel document of the applicant shall be affixed to that travel document. 5. Where the travel document in which such persons are included is not recognised by the issuing Member State, the individual stickers shall be affixed to the separate sheets for affixing a visa. Article 30 Rights derived from an issued visa Mere possession of a uniform visa or a visa with limited territorial validity shall not confer an automatic right of entry. Article 31 Information of central authorities of other Member States 1. A Member State may require that its central authorities be informed of visas issued by consulates of other Member States to nationals of specific third countries or to specific categories of such nationals, except in the case of airport transit visas. 2. Member States shall notify the Commission of the introduction or withdrawal of the requirement for such information before it becomes applicable. This information shall also be given within local Schengen cooperation in the jurisdiction concerned. 3. The Commission shall inform Member States of such notifications. 4. From the date referred to in Article 46 of the VIS Regulation, information shall be transmitted in accordance with Article 16(3) of that Regulation. Article 32 Refusal of a visa 1. Without prejudice to Article 25(1), a visa shall be refused: (a) if the applicant: (i) presents a travel document which is false, counterfeit or forged; (ii) does not provide justification for the purpose and conditions of the intended stay; (iii) does not provide proof of sufficient means of subsistence, both for the duration of the intended stay and for the return to his country of origin or residence, or for the transit to a third country into which he is certain to be admitted, or is not in a position to acquire such means lawfully; (iv) has already stayed for three months during the current six-month period on the territory of the Member States on the basis of a uniform visa or a visa with limited territorial validity; (v) is a person for whom an alert has been issued in the SIS for the purpose of refusing entry; (vi) is considered to be a threat to public policy, internal security or public health as defined in Article 2(19) of the Schengen Borders Code or to the international relations of any of the Member States, in particular where an alert has been issued in Member States\u2019 national databases for the purpose of refusing entry on the same grounds; or (vii) does not provide proof of holding adequate and valid travel medical insurance, where applicable; or (b) if there are reasonable doubts as to the authenticity of the supporting documents submitted by the applicant or the veracity of their contents, the reliability of the statements made by the applicant or his intention to leave the territory of the Member States before the expiry of the visa applied for. 2. A decision on refusal and the reasons on which it is based shall be notified to the applicant by means of the standard form set out in Annex VI. 3. Applicants who have been refused a visa shall have the right to appeal. Appeals shall be conducted against the Member State that has taken the final decision on the application and in accordance with the national law of that Member State. Member States shall provide applicants with information regarding the procedure to be followed in the event of an appeal, as specified in Annex VI. 4. In the cases referred to in Article 8(2), the consulate of the representing Member State shall inform the applicant of the decision taken by the represented Member State. 5. Information on a refused visa shall be entered into the VIS in accordance with Article 12 of the VIS Regulation. CHAPTER V Modification of an issued visa Article 33 Extension 1. The period of validity and/or the duration of stay of an issued visa shall be extended where the competent authority of a Member State considers that a visa holder has provided proof of force majeure or humanitarian reasons preventing him from leaving the territory of the Member States before the expiry of the period of validity of or the duration of stay authorised by the visa. Such an extension shall be granted free of charge. 2. The period of validity and/or the duration of stay of an issued visa may be extended if the visa holder provides proof of serious personal reasons justifying the extension of the period of validity or the duration of stay. A fee of EUR 30 shall be charged for such an extension. 3. Unless otherwise decided by the authority extending the visa, the territorial validity of the extended visa shall remain the same as that of the original visa. 4. The authority competent to extend the visa shall be that of the Member State on whose territory the third-country national is present at the moment of applying for an extension. 5. Member States shall notify to the Commission the authorities competent for extending visas. 6. Extension of visas shall take the form of a visa sticker. 7. Information on an extended visa shall be entered into the VIS in accordance with Article 14 of the VIS Regulation. Article 34 Annulment and revocation 1. A visa shall be annulled where it becomes evident that the conditions for issuing it were not met at the time when it was issued, in particular if there are serious grounds for believing that the visa was fraudulently obtained. A visa shall in principle be annulled by the competent authorities of the Member State which issued it. A visa may be annulled by the competent authorities of another Member State, in which case the authorities of the Member State that issued the visa shall be informed of such annulment. 2. A visa shall be revoked where it becomes evident that the conditions for issuing it are no longer met. A visa shall in principle be revoked by the competent authorities of the Member State which issued it. A visa may be revoked by the competent authorities of another Member State, in which case the authorities of the Member State that issued the visa shall be informed of such revocation. 3. A visa may be revoked at the request of the visa holder. The competent authorities of the Member States that issued the visa shall be informed of such revocation. 4. Failure of the visa holder to produce, at the border, one or more of the supporting documents referred to in Article 14(3), shall not automatically lead to a decision to annul or revoke the visa. 5. If a visa is annulled or revoked, a stamp stating \u2018ANNULLED\u2019 or \u2018REVOKED\u2019 shall be affixed to it and the optically variable feature of the visa sticker, the security feature \u2018latent image effect\u2019 as well as the term \u2018visa\u2019 shall be invalidated by being crossed out. 6. A decision on annulment or revocation of a visa and the reasons on which it is based shall be notified to the applicant by means of the standard form set out in Annex VI. 7. A visa holder whose visa has been annulled or revoked shall have the right to appeal, unless the visa was revoked at his request in accordance with paragraph 3. Appeals shall be conducted against the Member State that has taken the decision on the annulment or revocation and in accordance with the national law of that Member State. Member States shall provide applicants with information regarding the procedure to be followed in the event of an appeal, as specified in Annex VI. 8. Information on an annulled or a revoked visa shall be entered into the VIS in accordance with Article 13 of the VIS Regulation. CHAPTER VI Visas issued at the external borders Article 35 Visas applied for at the external border 1. In exceptional cases, visas may be issued at border crossing points if the following conditions are satisfied: (a) the applicant fulfils the conditions laid down in Article 5(1)(a), (c), (d) and (e) of the Schengen Borders Code; (b) the applicant has not been in a position to apply for a visa in advance and submits, if required, supporting documents substantiating unforeseeable and imperative reasons for entry; and (c) the applicant\u2019s return to his country of origin or residence or transit through States other than Member States fully implementing the Schengen acquis is assessed as certain. 2. Where a visa is applied for at the external border, the requirement that the applicant be in possession of travel medical insurance may be waived when such travel medical insurance is not available at that border crossing point or for humanitarian reasons. 3. A visa issued at the external border shall be a uniform visa, entitling the holder to stay for a maximum duration of 15 days, depending on the purpose and conditions of the intended stay. In the case of transit, the length of the authorised stay shall correspond to the time necessary for the purpose of the transit. 4. Where the conditions laid down in Article 5(1)(a), (c), (d) and (e) of the Schengen Borders Code are not fulfilled, the authorities responsible for issuing the visa at the border may issue a visa with limited territorial validity, in accordance with Article 25(1)(a) of this Regulation, for the territory of the issuing Member State only. 5. A third-country national falling within a category of persons for whom prior consultation is required in accordance with Article 22 shall, in principle, not be issued a visa at the external border. However, a visa with limited territorial validity for the territory of the issuing Member State may be issued at the external border for such persons in exceptional cases, in accordance with Article 25(1)(a). 6. In addition to the reasons for refusing a visa as provided for in Article 32(1) a visa shall be refused at the border crossing point if the conditions referred to in paragraph 1(b) of this Article are not met. 7. The provisions on justification and notification of refusals and the right of appeal set out in Article 32(3) and Annex VI shall apply. Article 36 Visas issued to seafarers in transit at the external border 1. A seafarer who is required to be in possession of a visa when crossing the external borders of the Member States may be issued with a visa for the purpose of transit at the border where: (a) he fulfils the conditions set out in Article 35(1); and (b) he is crossing the border in question in order to embark on, re-embark on or disembark from a ship on which he will work or has worked as a seafarer. 2. Before issuing a visa at the border to a seafarer in transit, the competent national authorities shall comply with the rules set out in Annex IX, Part 1, and make sure that the necessary information concerning the seafarer in question has been exchanged by means of a duly completed form for seafarers in transit, as set out in Annex IX, Part 2. 3. This Article shall apply without prejudice to Article 35(3), (4) and (5). TITLE IV ADMINISTRATIVE MANAGEMENT AND ORGANISATION Article 37 Organisation of visa sections 1. Member States shall be responsible for organising the visa sections of their consulates. In order to prevent any decline in the level of vigilance and to protect staff from being exposed to pressure at local level, rotation schemes for staff dealing directly with applicants shall be set up, where appropriate. Particular attention shall be paid to clear work structures and a distinct allocation/division of responsibilities in relation to the taking of final decisions on applications. Access to consultation of the VIS and the SIS and other confidential information shall be restricted to a limited number of duly authorised staff. Appropriate measures shall be taken to prevent unauthorised access to such databases. 2. The storage and handling of visa stickers shall be subject to adequate security measures to avoid fraud or loss. Each consulate shall keep an account of its stock of visa stickers and register how each visa sticker has been used. 3. Member States\u2019 consulates shall keep archives of applications. Each individual file shall contain the application form, copies of relevant supporting documents, a record of checks made and the reference number of the visa issued, in order for staff to be able to reconstruct, if need be, the background for the decision taken on the application. Individual application files shall be kept for a minimum of two years from the date of the decision on the application as referred to in Article 23(1). Article 38 Resources for examining applications and monitoring of consulates 1. Member States shall deploy appropriate staff in sufficient numbers to carry out the tasks relating to the examining of applications, in such a way as to ensure reasonable and harmonised quality of service to the public. 2. Premises shall meet appropriate functional requirements of adequacy and allow for appropriate security measures. 3. Member States\u2019 central authorities shall provide adequate training to both expatriate staff and locally employed staff and shall be responsible for providing them with complete, precise and up-to-date information on the relevant Community and national law. 4. Member States\u2019 central authorities shall ensure frequent and adequate monitoring of the conduct of examination of applications and take corrective measures when deviations from the provisions of this Regulation are detected. Article 39 Conduct of staff 1. Member States\u2019 consulates shall ensure that applicants are received courteously. 2. Consular staff shall, in the performance of their duties, fully respect human dignity. Any measures taken shall be proportionate to the objectives pursued by such measures. 3. While performing their tasks, consular staff shall not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation. Article 40 Forms of cooperation 1. Each Member State shall be responsible for organising the procedures relating to applications. In principle, applications shall be lodged at a consulate of a Member State. 2. Member States shall: (a) equip their consulates and authorities responsible for issuing visas at the borders with the required material for the collection of biometric identifiers, as well as the offices of their honorary consuls, whenever they make use of them, to collect biometric identifiers in accordance with Article 42; and/or (b) cooperate with one or more other Member States, within the framework of local Schengen cooperation or by other appropriate contacts, in the form of limited representation, co-location, or a Common Application Centre in accordance with Article 41. 3. In particular circumstances or for reasons relating to the local situation, such as where: (a) the high number of applicants does not allow the collection of applications and of data to be organised in a timely manner and in decent conditions; or (b) it is not possible to ensure a good territorial coverage of the third country concerned in any other way; and where the forms of cooperation referred to in paragraph 2(b) prove not to be appropriate for the Member State concerned, a Member State may, as a last resort, cooperate with an external service provider in accordance with Article 43. 4. Without prejudice to the right to call the applicant for a personal interview, as provided for in Article 21(8), the selection of a form of organisation shall not lead to the applicant being required to appear in person at more than one location in order to lodge an application. 5. Member States shall notify to the Commission how they intend to organise the procedures relating to applications in each consular location. Article 41 Cooperation between Member States 1. Where \u2018co-location\u2019 is chosen, staff of the consulates of one or more Member States shall carry out the procedures relating to applications (including the collection of biometric identifiers) addressed to them at the consulate of another Member State and share the equipment of that Member State. The Member States concerned shall agree on the duration of and conditions for the termination of the co-location as well as the proportion of the visa fee to be received by the Member State whose consulate is being used. 2. Where \u2018Common Application Centres\u2019 are established, staff of the consulates of two or more Member States shall be pooled in one building in order for applicants to lodge applications (including biometric identifiers). Applicants shall be directed to the Member State competent for examining and deciding on the application. Member States shall agree on the duration of and conditions for the termination of such cooperation as well as the cost-sharing among the participating Member States. One Member State shall be responsible for contracts in relation to logistics and diplomatic relations with the host country. 3. In the event of termination of cooperation with other Member States, Member States shall assure the continuity of full service. Article 42 Recourse to honorary consuls 1. Honorary consuls may also be authorised to perform some or all of the tasks referred to in Article 43(6). Adequate measures shall be taken to ensure security and data protection. 2. Where the honorary consul is not a civil servant of a Member State, the performance of those tasks shall comply with the requirements set out in Annex X, except for the provisions in point D(c) of that Annex. 3. Where the honorary consul is a civil servant of a Member State, the Member State concerned shall ensure that requirements comparable to those which would apply if the tasks were performed by its consulate are applied. Article 43 Cooperation with external service providers 1. Member States shall endeavour to cooperate with an external service provider together with one or more Member States, without prejudice to public procurement and competition rules. 2. Cooperation with an external service provider shall be based on a legal instrument that shall comply with the requirements set out in Annex X. 3. Member States shall, within the framework of local Schengen cooperation, exchange information about the selection of external service providers and the establishment of the terms and conditions of their respective legal instruments. 4. The examination of applications, interviews (where appropriate), the decision on applications and the printing and affixing of visa stickers shall be carried out only by the consulate. 5. External service providers shall not have access to the VIS under any circumstances. Access to the VIS shall be reserved exclusively to duly authorised staff of consulates. 6. An external service provider may be entrusted with the performance of one or more of the following tasks: (a) providing general information on visa requirements and application forms; (b) informing the applicant of the required supporting documents, on the basis of a checklist; (c) collecting data and applications (including collection of biometric identifiers) and transmitting the application to the consulate; (d) collecting the visa fee; (e) managing the appointments for appearance in person at the consulate or at the external service provider; (f) collecting the travel documents, including a refusal notification if applicable, from the consulate and returning them to the applicant. 7. When selecting an external service provider, the Member State(s) concerned shall scrutinise the solvency and reliability of the company, including the necessary licences, commercial registration, company statutes, bank contracts, and ensure that there is no conflict of interests. 8. The Member State(s) concerned shall ensure that the external service provider selected complies with the terms and conditions assigned to it in the legal instrument referred to in paragraph 2. 9. The Member State(s) concerned shall remain responsible for compliance with data protection rules for the processing of data and shall be supervised in accordance with Article 28 of Directive 95/46/EC. Cooperation with an external service provider shall not limit or exclude any liability arising under the national law of the Member State(s) concerned for breaches of obligations with regard to the personal data of applicants or the performance of one or more of the tasks referred to in paragraph 6. This provision is without prejudice to any action which may be taken directly against the external service provider under the national law of the third country concerned. 10. The Member State(s) concerned shall provide training to the external service provider, corresponding to the knowledge needed to offer an appropriate service and sufficient information to applicants. 11. The Member State(s) concerned shall closely monitor the implementation of the legal instrument referred to in paragraph 2, including: (a) the general information on visa requirements and application forms provided by the external service provider to applicants; (b) all the technical and organisational security measures required to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the cooperation involves the transmission of files and data to the consulate of the Member State(s) concerned, and all other unlawful forms of processing personal data; (c) the collection and transmission of biometric identifiers; (d) the measures taken to ensure compliance with data protection provisions. To this end, the consulate(s) of the Member State(s) concerned shall, on a regular basis, carry out spot checks on the premises of the external service provider. 12. In the event of termination of cooperation with an external service provider, Member States shall ensure the continuity of full service. 13. Member States shall provide the Commission with a copy of the legal instrument referred to in paragraph 2. Article 44 Encryption and secure transfer of data 1. In the case of representation arrangements between Member States and cooperation of Member States with an external service provider and recourse to honorary consuls, the represented Member State(s) or the Member State(s) concerned shall ensure that the data are fully encrypted, whether electronically transferred or physically transferred on an electronic storage medium from the authorities of the representing Member State to the authorities of the represented Member State(s) or from the external service provider or from the honorary consul to the authorities of the Member State(s) concerned. 2. In third countries which prohibit encryption of data to be electronically transferred from the authorities of the representing Member State to the authorities of the represented Member State(s) or from the external service provider or from the honorary consul to the authorities of the Member State(s) concerned, the represented Members State(s) or the Member State(s) concerned shall not allow the representing Member State or the external service provider or the honorary consul to transfer data electronically. In such a case, the represented Member State(s) or the Member State(s) concerned shall ensure that the electronic data are transferred physically in fully encrypted form on an electronic storage medium from the authorities of the representing Member State to the authorities of the represented Member State(s) or from the external service provider or from the honorary consul to the authorities of the Member State(s) concerned by a consular officer of a Member State or, where such a transfer would require disproportionate or unreasonable measures to be taken, in another safe and secure way, for example by using established operators experienced in transporting sensitive documents and data in the third country concerned. 3. In all cases the level of security for the transfer shall be adapted to the sensitive nature of the data. 4. The Member States or the Community shall endeavour to reach agreement with the third countries concerned with the aim of lifting the prohibition against encryption of data to be electronically transferred from the authorities of the representing Member State to the authorities of the represented Member State(s) or from the external service provider or from the honorary consul to the authorities of the Member State(s) concerned. Article 45 Member States\u2019 cooperation with commercial intermediaries 1. Member States may cooperate with commercial intermediaries for the lodging of applications, except for the collection of biometric identifiers. 2. Such cooperation shall be based on the granting of an accreditation by Member States\u2019 relevant authorities. The accreditation shall, in particular, be based on the verification of the following aspects: (a) the current status of the commercial intermediary: current licence, the commercial register, contracts with banks; (b) existing contracts with commercial partners based in the Member States offering accommodation and other package tour services; (c) contracts with transport companies, which must include an outward journey, as well as a guaranteed and fixed return journey. 3. Accredited commercial intermediaries shall be monitored regularly by spot checks involving personal or telephone interviews with applicants, verification of trips and accommodation, verification that the travel medical insurance provided is adequate and covers individual travellers, and wherever deemed necessary, verification of the documents relating to group return. 4. Within local Schengen cooperation, information shall be exchanged on the performance of the accredited commercial intermediaries concerning irregularities detected and refusal of applications submitted by commercial intermediaries, and on detected forms of travel document fraud and failure to carry out scheduled trips. 5. Within local Schengen cooperation, lists shall be exchanged of commercial intermediaries to which accreditation has been given by each consulate and from which accreditation has been withdrawn, together with the reasons for any such withdrawal. Each consulate shall make sure that the public is informed about the list of accredited commercial intermediaries with which it cooperates. Article 46 Compilation of statistics Member States shall compile annual statistics on visas, in accordance with the table set out in Annex XII. These statistics shall be submitted by 1 March for the preceding calendar year. Article 47 Information to the general public 1. Member States\u2019 central authorities and consulates shall provide the general public with all relevant information in relation to the application for a visa, in particular: (a) the criteria, conditions and procedures for applying for a visa; (b) the means of obtaining an appointment, if applicable; (c) where the application may be submitted (competent consulate, Common Application Centre or external service provider); (d) accredited commercial intermediaries; (e) the fact that the stamp as provided for in Article 20 has no legal implications; (f) the time limits for examining applications provided for in Article 23(1), (2) and (3); (g) the third countries whose nationals or specific categories of whose nationals are subject to prior consultation or information; (h) that negative decisions on applications must be notified to the applicant, that such decisions must state the reasons on which they are based and that applicants whose applications are refused have a right to appeal, with information regarding the procedure to be followed in the event of an appeal, including the competent authority, as well as the time limit for lodging an appeal; (i) that mere possession of a visa does not confer an automatic right of entry and that the holders of visa are requested to present proof that they fulfil the entry conditions at the external border, as provided for in Article 5 of the Schengen Borders Code. 2. The representing and represented Member State shall inform the general public about representation arrangements as referred to in Article 8 before such arrangements enter into force. TITLE V LOCAL SCHENGEN COOPERATION Article 48 Local Schengen cooperation between Member States\u2019 consulates 1. In order to ensure a harmonised application of the common visa policy taking into account, where appropriate, local circumstances, Member States\u2019 consulates and the Commission shall cooperate within each jurisdiction and assess the need to establish in particular: (a) a harmonised list of supporting documents to be submitted by applicants, taking into account Article 14 and Annex II; (b) common criteria for examining applications in relation to exemptions from paying the visa fee in accordance with Article 16(5) and matters relating to the translation of the application form in accordance with Article 11(5); (c) an exhaustive list of travel documents issued by the host country, which shall be updated regularly. If in relation to one or more of the points (a) to (c), the assessment within local Schengen cooperation confirms the need for a local harmonised approach, measures on such an approach shall be adopted pursuant to the procedure referred to in Article 52(2). 2. Within local Schengen cooperation a common information sheet shall be established on uniform visas and visas with limited territorial validity and airport transit visas, namely, the rights that the visa implies and the conditions for applying for it, including, where applicable, the list of supporting documents as referred to in paragraph 1(a). 3. The following information shall be exchanged within local Schengen cooperation: (a) monthly statistics on uniform visas, visas with limited territorial validity, and airport transit visas issued, as well as the number of visas refused; (b) with regard to the assessment of migratory and/or security risks, information on: (i) the socioeconomic structure of the host country; (ii) sources of information at local level, including social security, health insurance, fiscal registers and entry-exit registrations; (iii) the use of false, counterfeit or forged documents; (iv) illegal immigration routes; (v) refusals; (c) information on cooperation with transport companies; (d) information on insurance companies providing adequate travel medical insurance, including verification of the type of coverage and possible excess amount. 4. Local Schengen cooperation meetings to deal specifically with operational issues in relation to the application of the common visa policy shall be organised regularly among Member States and the Commission. These meetings shall be convened within the jurisdiction by the Commission, unless otherwise agreed at the request of the Commission. Single-topic meetings may be organised and sub-groups set up to study specific issues within local Schengen cooperation. 5. Summary reports of local Schengen cooperation meetings shall be drawn up systematically and circulated locally. The Commission may delegate the drawing up of the reports to a Member State. The consulates of each Member State shall forward the reports to their central authorities. On the basis of these reports, the Commission shall draw up an annual report within each jurisdiction to be submitted to the European Parliament and the Council. 6. Representatives of the consulates of Member States not applying the Community acquis in relation to visas, or of third countries, may on an ad hoc basis be invited to participate in meetings for the exchange of information on issues relating to visas. TITLE VI FINAL PROVISIONS Article 49 Arrangements in relation to the Olympic Games and Paralympic Games Member States hosting the Olympic Games and Paralympic Games shall apply the specific procedures and conditions facilitating the issuing of visas set out in Annex XI. Article 50 Amendments to the Annexes Measures designed to amend non-essential elements of this Regulation and amending Annexes I, II, III, IV, V, VI, VII, VIII and XII shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(3). Article 51 Instructions on the practical application of the Visa Code Operational instructions on the practical application of the provisions of this Regulation shall be drawn up in accordance with the procedure referred to in Article 52(2). Article 52 Committee procedure 1. The Commission shall be assisted by a committee (the Visa Committee). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof and provided that the implementing measures adopted in accordance with this procedure do not modify the essential provisions of this Regulation. The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months. 3. Where reference is made to this paragraph, Articles 5a(1) to (4) and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 53 Notification 1. Member States shall notify the Commission of: (a) representation arrangements referred to in Article 8; (b) third countries whose nationals are required by individual Member States to hold an airport transit visa when passing through the international transit areas of airports situated on their territory, as referred to in Article 3; (c) the national form for proof of sponsorship and/or private accommodation referred to in Article 14(4), if applicable; (d) the list of third countries for which prior consultation referred to in Article 22(1) is required; (e) the list of third countries for which information referred to in Article 31(1) is required; (f) the additional national entries in the \u2018comments\u2019 section of the visa sticker, as referred to in Article 27(2); (g) authorities competent for extending visas, as referred to in Article 33(5); (h) the forms of cooperation chosen as referred to in Article 40; (i) statistics compiled in accordance with Article 46 and Annex XII. 2. The Commission shall make the information notified pursuant to paragraph 1 available to the Member States and the public via a constantly updated electronic publication. Article 54 Amendments to Regulation (EC) No 767/2008 Regulation (EC) No 767/2008 is hereby amended as follows: 1. Article 4(1) shall be amended as follows: (a) point (a) shall be replaced by the following: \u2018(a) \u201cuniform visa\u201d as defined in Article 2(3) of Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community code on Visas (Visa Code) (22); (b) point (b) shall be deleted; (c) point (c) shall be replaced by the following: \u2018(c) \u201cairport transit visa\u201d as defined in Article 2(5) of Regulation (EC) No 810/2009;\u2019; (d) point (d) shall be replaced by the following: \u2018(d) \u201cvisa with limited territorial validity\u201d as defined in Article 2(4) of Regulation (EC) No 810/2009;\u2019; (e) point (e) shall be deleted; 2. in Article 8(1), the words \u2018On receipt of an application\u2019, shall be replaced by the following: \u2018When the application is admissible according to Article 19 of Regulation (EC) No 810/2009\u2019; 3. Article 9 shall be amended as follows: (a) the heading shall be replaced by the following: \u2018Data to be entered on application\u2019; (b) paragraph 4 shall be amended as follows: (i) point (a) shall be replaced by the following: \u2018(a) surname (family name), surname at birth (former family name(s)), first name(s) (given name(s)); date of birth, place of birth, country of birth, sex;\u2019; (ii) point (e) shall be deleted; (iii) point (g) shall be replaced by the following: \u2018(g) Member State(s) of destination and duration of the intended stay or transit;\u2019; (iv) point (h) shall be replaced by the following: \u2018(h) main purpose(s) of the journey;\u2019; (v) point (i) shall be replaced by the following: \u2018(i) intended date of arrival in the Schengen area and intended date of departure from the Schengen area;\u2019; (vi) point (j) shall be replaced by the following: \u2018(j) Member State of first entry;\u2019; (vii) point (k) shall be replaced by the following: \u2018(k) the applicant\u2019s home address;\u2019; (viii) in point (l), the word \u2018school\u2019 shall be replaced by: \u2018educational establishment\u2019; (ix) in point (m), the words \u2018father and mother\u2019 shall be replaced by \u2018parental authority or legal guardian\u2019; 4. the following point shall be added to Article 10(1): \u2018(k) if applicable, the information indicating that the visa sticker has been filled in manually.\u2019; 5. in Article 11, the introductory paragraph shall be replaced by the following: \u2018Where the visa authority representing another Member State discontinues the examination of the application, it shall add the following data to the application file:\u2019; 6. Article 12 shall be amended as follows: (a) in paragraph 1, point (a) shall be replaced by the following: \u2018(a) status information indicating that the visa has been refused and whether that authority refused it on behalf of another Member State;\u2019; (b) paragraph 2 shall be replaced by the following: \u20182. The application file shall also indicate the ground(s) for refusal of the visa, which shall be one or more of the following: (a) the applicant: (i) presents a travel document which is false, counterfeit or forged; (ii) does not provide justification for the purpose and conditions of the intended stay; (iii) does not provide proof of sufficient means of subsistence, both for the duration of the intended stay and for the return to his country of origin or residence, or for the transit to a third country into which he is certain to be admitted, or is not in a position to acquire such means lawfully; (iv) has already stayed for three months during the current six-month period on the territory of the Member States on a basis of a uniform visa or a visa with limited territorial validity; (v) is a person for whom an alert has been issued in the SIS for the purpose of refusing entry; (vi) is considered to be a threat to public policy, internal security or public health as defined in Article 2(19) of the Schengen Borders Code or to the international relations of any of the Member States, in particular where an alert has been issued in Member States\u2019 national databases for the purpose of refusing entry on the same grounds; (vii) does not provide proof of holding adequate and valid travel medical insurance, where applicable; (b) the information submitted regarding the justification for the purpose and conditions of the intended stay was not reliable; (c) the applicant\u2019s intention to leave the territory of the Member States before the expiry of the visa could not be ascertained; (d) sufficient proof that the applicant has not been in a position to apply for a visa in advance justifying application for a visa at the border was not provided.\u2019; 7. Article 13 shall be replaced by the following: \u2018Article 13 Data to be added for a visa annulled or revoked 1. Where a decision has been taken to annul or to revoke a visa, the visa authority that has taken the decision shall add the following data to the application file: (a) status information indicating that the visa has been annulled or revoked; (b) authority that annulled or revoked the visa, including its location; (c) place and date of the decision. 2. The application file shall also indicate the ground(s) for annulment or revocation, which shall be: (a) one or more of the ground(s) listed in Article 12(2); (b) the request of the visa holder to revoke the visa.\u2019; 8. Article 14 shall be amended as follows: (a) paragraph 1 shall be amended as follows: (i) the introductory paragraph shall be replaced by the following: \u20181. Where a decision has been taken to extend the period of validity and/or the duration of stay of an issued visa, the visa authority which extended the visa shall add the following data to the application file:\u2019; (ii) point (d) shall be replaced by the following: \u2018(d) the number of the visa sticker of the extended visa;\u2019; (iii) point (g) shall be replaced by the following: \u2018(g) the territory in which the visa holder is entitled to travel, if the territorial validity of the extended visa differs from that of the original visa;\u2019; (b) in paragraph 2, point (c) shall be deleted; 9. in Article 15(1), the words \u2018extend or shorten the validity of the visa\u2019 shall be replaced by \u2018or extend the visa\u2019; 10. Article 17 shall be amended as follows: (a) point 4 shall be replaced by the following: \u20184. Member State of first entry;\u2019; (b) point 6 shall be replaced by the following: \u20186. the type of visa issued;\u2019; (c) point 11 shall be replaced by the following: \u201811. main purpose(s) of the journey;\u2019; 11. in Article 18(4)(c), Article 19(2)(c), Article 20(2)(d), Article 22(2)(d), the words \u2018or shortened\u2019 shall be deleted; 12. in Article 23(1)(d), the word \u2018shortened\u2019 shall be deleted. Article 55 Amendments to Regulation (EC) No 562/2006 Annex V, Part A of Regulation (EC) No 562/2006 is hereby amended as follows: (a) point 1(c), shall be replaced by the following: \u2018(c) annul or revoke the visas, as appropriate, in accordance with the conditions laid down in Article 34 of Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community code on visas (Visa Code) (23); (b) point 2 shall be deleted. Article 56 Repeals 1. Articles 9 to 17 of the Convention implementing the Schengen Agreement of 14 June 1985 shall be repealed. 2. The following shall be repealed: (a) Decision of the Schengen Executive Committee of 28 April 1999 on the definitive versions of the Common Manual and the Common Consular Instructions (SCH/Com-ex (99) 13 (the Common Consular Instructions, including the Annexes); (b) Decisions of the Schengen Executive Committee of 14 December 1993 extending the uniform visa (SCH/Com-ex (93) 21) and on the common principles for cancelling, rescinding or shortening the length of validity of the uniform visa (SCH/Com-ex (93) 24), Decision of the Schengen Executive Committee of 22 December 1994 on the exchange of statistical information on the issuing of uniform visas (SCH/Com-ex (94) 25), Decision of the Schengen Executive Committee of 21 April 1998 on the exchange of statistics on issued visas (SCH/Com-ex (98) 12) and Decision of the Schengen Executive Committee of 16 December 1998 on the introduction of a harmonised form providing proof of invitation, sponsorship and accommodation (SCH/Com-ex (98) 57); (c) Joint Action 96/197/JHA of 4 March 1996 on airport transit arrangements (24); (d) Council Regulation (EC) No 789/2001 of 24 April 2001 reserving to the Council implementing powers with regard to certain detailed provisions and practical procedures for examining visa applications (25); (e) Council Regulation (EC) No 1091/2001 of 28 May 2001 on freedom of movement with a long-stay visa (26); (f) Council Regulation (EC) No 415/2003 of 27 February 2003 on the issue of visas at the border, including the issue of such visas to seamen in transit (27); (g) Article 2 of Regulation (EC) No 390/2009 of the European Parliament and of the Council of 23 April 2009 amending the Common Consular Instructions on visas for diplomatic and consular posts in relation to the introduction of biometrics including provisions on the organisation of the reception and processing of visa applications (28). 3. References to repealed instruments shall be construed as references to this Regulation and read in accordance with the correlation table in Annex XIII. Article 57 Monitoring and evaluation 1. Two years after all the provisions of this Regulation have become applicable, the Commission shall produce an evaluation of its application. This overall evaluation shall include an examination of the results achieved against objectives and of the implementation of the provisions of this Regulation, without prejudice to the reports referred to in paragraph 3. 2. The Commission shall transmit the evaluation referred to in paragraph 1 to the European Parliament and the Council. On the basis of the evaluation, the Commission shall submit, if necessary, appropriate proposals with a view to amending this Regulation. 3. The Commission shall present, three years after the VIS is brought into operation and every four years thereafter, a report to the European Parliament and to the Council on the implementation of Articles 13, 17, 40 to 44 of this Regulation, including the implementation of the collection and use of biometric identifiers, the suitability of the ICAO standard chosen, compliance with data protection rules, experience with external service providers with specific reference to the collection of biometric data, the implementation of the 59-month rule for the copying of fingerprints and the organisation of the procedures relating to applications. The report shall also include, on the basis of Article 17(12), (13) and (14) and of Article 50(4) of the VIS Regulation, the cases in which fingerprints could factually not be provided or were not required to be provided for legal reasons, compared with the number of cases in which fingerprints were taken. The report shall include information on cases in which a person who could factually not provide fingerprints was refused a visa. The report shall be accompanied, where necessary, by appropriate proposals to amend this Regulation. 4. The first of the reports referred to in paragraph 3 shall also address the issue of the sufficient reliability for identification and verification purposes of fingerprints of children under the age of 12 and, in particular, how fingerprints evolve with age, on the basis of the results of a study carried out under the responsibility of the Commission. Article 58 Entry into force 1. This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. 2. It shall apply from 5 April 2010. 3. Article 52 and Article 53(1)(a) to (h) and (2) shall apply from 5 October 2009. 4. As far as the Schengen Consultation Network (Technical Specifications) is concerned, Article 56(2)(d) shall apply from the date referred to in Article 46 of the VIS Regulation. 5. Article 32(2) and (3), Article 34(6) and (7) and Article 35(7) shall apply from 5 April 2011. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaty establishing the European Community. Done at Brussels, 13 July 2009. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President E. ERLANDSSON (1) Opinion of the European Parliament of 2 April 2009 (not yet published in the Official Journal) and Council Decision of 25 June 2009. (2) OJ L 239, 22.9.2000, p. 19. (3) OJ C 326, 22.12.2005, p. 1. (4) OJ C 53, 3.3.2005, p. 1. (5) OJ L 218, 13.8.2008, p. 60. (6) OJ L 281, 23.11.1995, p. 31. (7) OJ L 184, 17.7.1999, p. 23. (8) OJ L 105, 13.4.2006, p. 1. (9) OJ L 176, 10.7.1999, p. 36. (10) OJ L 176, 10.7.1999, p. 31. (11) OJ L 176, 10.7.1999, p. 53. (12) OJ L 53, 27.2.2008, p. 52. (13) OJ L 53, 27.2.2008, p. 1. (14) OJ L 83, 26.3.2008, p. 3. (15) OJ L 131, 1.6.2000, p. 43. (16) OJ L 64, 7.3.2002, p. 20. (17) OJ L 81, 21.3.2001, p. 1. (18) OJ L 164, 14.7.1995, p. 1. (19) OJ L 53, 23.2.2002, p. 4. (20) OJ L 267, 27.9.2006, p. 41. (21) OJ L 289, 3.11.2005, p. 23. (22) OJ L 243, 15.9.2009, p. 1.\u2019; (23) OJ L 243, 15.9.2009, p. 1.\u2019; (24) OJ L 63, 13.3.1996, p. 8. (25) OJ L 116, 26.4.2001, p. 2. (26) OJ L 150, 6.6.2001, p. 4. (27) OJ L 64, 7.3.2003, p. 1. (28) OJ L 131, 28.5.2009, p. 1. ANNEX I ANNEX II Non-exhaustive list of supporting documents The supporting documents referred to in Article 14, to be submitted by visa applicants may include the following: A. DOCUMENTATION RELATING TO THE PURPOSE OF THE JOURNEY 1. for business trips: (a) an invitation from a firm or an authority to attend meetings, conferences or events connected with trade, industry or work; (b) other documents which show the existence of trade relations or relations for work purposes; (c) entry tickets for fairs and congresses, if appropriate; (d) documents proving the business activities of the company; (e) documents proving the applicant\u2019s employment status in the company; 2. for journeys undertaken for the purposes of study or other types of training: (a) a certificate of enrolment at an educational establishment for the purposes of attending vocational or theoretical courses within the framework of basic and further training; (b) student cards or certificates of the courses to be attended; 3. for journeys undertaken for the purposes of tourism or for private reasons: (a) documents relating to accommodation: \u2014 an invitation from the host if staying with one, \u2014 a document from the establishment providing accommodation or any other appropriate document indicating the accommodation envisaged; (b) documents relating to the itinerary: \u2014 confirmation of the booking of an organised trip or any other appropriate document indicating the envisaged travel plans, \u2014 in the case of transit: visa or other entry permit for the third country of destination; tickets for onward journey; 4. for journeys undertaken for political, scientific, cultural, sports or religious events or other reasons: \u2014 invitation, entry tickets, enrolments or programmes stating (wherever possible) the name of the host organisation and the length of stay or any other appropriate document indicating the purpose of the journey; 5. for journeys of members of official delegations who, following an official invitation addressed to the government of the third country concerned, participate in meetings, consultations, negotiations or exchange programmes, as well as in events held in the territory of a Member State by intergovernmental organisations: \u2014 a letter issued by an authority of the third country concerned confirming that the applicant is a member of the official delegation travelling to a Member State to participate in the abovementioned events, accompanied by a copy of the official invitation; 6. for journeys undertaken for medical reasons: \u2014 an official document of the medical institution confirming necessity for medical care in that institution and proof of sufficient financial means to pay for the medical treatment. B. DOCUMENTATION ALLOWING FOR THE ASSESSMENT OF THE APPLICANT\u2019S INTENTION TO LEAVE THE TERRITORY OF THE MEMBER STATES 1. reservation of or return or round ticket; 2. proof of financial means in the country of residence; 3. proof of employment: bank statements; 4. proof of real estate property; 5. proof of integration into the country of residence: family ties; professional status. C. DOCUMENTATION IN RELATION TO THE APPLICANT\u2019S FAMILY SITUATION 1. consent of parental authority or legal guardian (when a minor does not travel with them); 2. proof of family ties with the host/inviting person. ANNEX III UNIFORM FORMAT AND USE OF THE STAMP INDICATING THAT A VISA APPLICATION IS ADMISSIBLE \u2026 visa \u2026 (1) xx/xx/xxxx (2) \u2026 (3) Example: C visa FR 22.4.2009 Consulat de France Djibouti The stamp shall be placed on the first available page that contains no entries or stamps in the travel document. (1) Code of the Member State examining the application. The codes as set out in Annex VII point 1.1 are used. (2) Date of application (eight digits: xx day, xx month, xxxx year). (3) Authority examining the visa application. ANNEX IV Common list of third countries listed in Annex I to Regulation (EC) No 539/2001, whose nationals are required to be in possession of an airport transit visa when passing through the international transit area of airports situated on the territory of the Member States AFGHANISTAN BANGLADESH DEMOCRATIC REPUBLIC OF THE CONGO ERITREA ETHIOPIA GHANA IRAN IRAQ NIGERIA PAKISTAN SOMALIA SRI LANKA ANNEX V LIST OF RESIDENCE PERMITS ENTITLING THEIR HOLDERS TO TRANSIT THROUGH THE AIRPORTS OF MEMBER STATES WITHOUT BEING REQUIRED TO HOLD AN AIRPORT TRANSIT VISA ANDORRA: \u2014 Tarjeta provisional de estancia y de trabajo (provisional residence and work permit) (white). These are issued to seasonal workers; the period of validity depends on the duration of employment, but never exceeds six months. This permit is not renewable, \u2014 Tarjeta de estancia y de trabajo (residence and work permit) (white). This permit is issued for six months and may be renewed for another year, \u2014 Tarjeta de estancia (residence permit) (white). This permit is issued for six months and may be renewed for another year, \u2014 Tarjeta temporal de residencia (temporary residence permit) (pink). This permit is issued for one year and may be renewed twice, each time for another year, \u2014 Tarjeta ordinaria de residencia (ordinary residence permit) (yellow). This permit is issued for three years and may be renewed for another three years, \u2014 Tarjeta privilegiada de residencia (special residence permit) (green). This permit is issued for five years and is renewable, each time for another five years, \u2014 Autorizaci\u00f3n de residencia (residence authorisation) (green). This permit is issued for one year and is renewable, each time for another three years, \u2014 Autorizaci\u00f3n temporal de residencia y de trabajo (temporary residence and work authorisation) (pink). This permit is issued for two years and may be renewed for another two years, \u2014 Autorizaci\u00f3n ordinaria de residencia y de trabajo (ordinary residence and work authorisation) (yellow). This permit is issued for five years, \u2014 Autorizaci\u00f3n privilegiada de residencia y de trabajo (special residence and work authorisation) (green). This permit is issued for 10 years and is renewable, each time for another 10 years. CANADA: \u2014 Permanent resident card (plastic card). JAPAN: \u2014 Re-entry permit to Japan. SAN MARINO: \u2014 Permesso di soggiorno ordinario (validit\u00e0 illimitata) (ordinary residence permit (no expiry date)), \u2014 Permesso di soggiorno continuativo speciale (validit\u00e0 illimitata) (special permanent residence permit (no expiry date)), \u2014 Carta d\u2019identit\u00e0 de San Marino (validit\u00e0 illimitata) (San Marino identity card (no expiry date)). UNITED STATES OF AMERICA: \u2014 Form I-551 permanent resident card (valid for 2 to 10 years), \u2014 Form I-551 Alien registration receipt card (valid for 2 to 10 years), \u2014 Form I-551 Alien registration receipt card (no expiry date), \u2014 Form I-327 Re-entry document (valid for two years \u2014 issued to holders of a I-551), \u2014 Resident alien card (valid for 2 or 10 years or no expiry date. This document guarantees the holder\u2019s return only if his stay outside the USA has not exceeded one year), \u2014 Permit to re-enter (valid for two years. This document guarantees the holder\u2019s return only if his stay outside the USA has not exceeded two years), \u2014 Valid temporary residence stamp in a valid passport (valid for one year from the date of issue). ANNEX VI ANNEX VII FILLING IN THE VISA STICKER 1. Mandatory entries section 1.1. \u2018VALID FOR\u2019 heading: This heading indicates the territory in which the visa holder is entitled to travel. This heading may be completed in one of the following ways only: (a) Schengen States; (b) Schengen State or Schengen States to whose territory the validity of the visa is limited (in this case the following abbreviations are used): BE BELGIUM CZ CZECH REPUBLIC DK DENMARK DE GERMANY EE ESTONIA GR GREECE ES SPAIN FR FRANCE IT ITALY LV LATVIA LT LITHUANIA LU LUXEMBOURG HU HUNGARY MT MALTA NL NETHERLANDS AT AUSTRIA PL POLAND PT PORTUGAL SI SLOVENIA SK SLOVAKIA FI FINLAND SE SWEDEN IS ICELAND NO NORWAY CH SWITZERLAND 1.2. When the sticker is used to issue a uniform visa this heading is filled in using the words \u2018Schengen States\u2019, in the language of the issuing Member State. 1.3. When the sticker is used to issue a visa with limited territorial validity pursuant to Article 25(1) of this Regulation this heading is filled in with the name(s) of the Member State(s) to which the visa holder\u2019s stay is limited, in the language of the issuing Member State. 1.4. When the sticker is used to issue a visa with limited territorial validity pursuant to Article 25(3) of this Regulation, the following options for the codes to be entered may be used: (a) entry of the codes for the Member States concerned; (b) entry of the words \u2018Schengen States\u2019, followed in brackets by the minus sign and the codes of the Member States for whose territory the visa is not valid; (c) in case the \u2018valid for\u2019 field is not sufficient for entering all codes for the Member States (not) recognising the travel document concerned the font size of the letters used is reduced. 2. \u2018FROM ... TO\u2019 heading: This heading indicates the period of the visa holder\u2019s stay as authorised by the visa. The date from which the visa holder may enter the territory for which the visa is valid is written as below, following the word \u2018FROM\u2019: \u2014 the day is written using two digits, the first of which is a zero if the day in question is a single digit, \u2014 horizontal dash, \u2014 the month is written using two digits, the first of which is a zero if the month in question is a single digit, \u2014 horizontal dash, \u2014 the year is written using two digits, which correspond with the last two digits of the year. For example: 05-12-07 = 5 December 2007. The date of the last day of the period of the visa holder\u2019s authorised stay is entered after the word \u2018TO\u2019 and is written in the same way as the first date. The visa holder must have left the territory for which the visa is valid by midnight on that date. 3. \u2018NUMBER OF ENTRIES\u2019 heading: This heading shows the number of times the visa holder may enter the territory for which the visa is valid, i.e. it refers to the number of periods of stay which may be spread over the entire period of validity, see 4. The number of entries may be one, two or more. This number is written to the right-hand side of the preprinted part, using \u201801\u2019, \u201802\u2019 or the abbreviation \u2018MULT\u2019, where the visa authorises more than two entries. When a multiple airport transit visa is issued pursuant to Article 26(3) of this Regulation, the visa\u2019s validity is calculated as follows: first date of departure plus six months. The visa is no longer valid when the total number of exits made by the visa holder equals the number of authorised entries, even if the visa holder has not used up the number of days authorised by the visa. 4. \u2018DURATION OF VISIT ... DAYS\u2019 heading: This heading indicates the number of days during which the visa holder may stay in the territory for which the visa is valid. This stay may be continuous or, depending on the number of days authorised, spread over several periods between the dates mentioned under 2, bearing in mind the number of entries authorised under 3. The number of days authorised is written in the blank space between \u2018DURATION OF VISIT\u2019 and \u2018DAYS\u2019, in the form of two digits, the first of which is a zero if the number of days is less than 10. The maximum number of days that may be entered under this heading is 90. When a visa is valid for more than six months, the duration of stays is 90 days in every six-month period. 5. \u2018ISSUED IN ... ON \u2026\u2019 heading: This heading gives the name of the location where the issuing authority is situated. The date of issue is indicated after \u2018ON\u2019. The date of issue is written in the same way as the date referred to in 2. 6. \u2018PASSPORT NUMBER\u2019 heading: This heading indicates the number of the travel document to which the visa sticker is affixed. In case the person to whom the visa is issued is included in the passport of the spouse, parental authority or legal guardian, the number of the travel document of that person is indicated. When the applicant\u2019s travel document is not recognised by the issuing Member State, the uniform format for the separate sheet for affixing visas is used for affixing the visa. The number to be entered under this heading, if the visa sticker is affixed to the separate sheet, is not the passport number but the same typographical number as appears on the form, made up of six digits. 7. \u2018TYPE OF VISA\u2019 heading: In order to facilitate matters for the control authorities, this heading specifies the type of visa using the letters A, C and D as follows: A : airport transit visa (as defined in Article 2(5) of this Regulation) C : visa (as defined in Article 2(2) of this Regulation) D : long-stay visa 8. \u2018SURNAME AND FIRST NAME\u2019 heading: The first word in the \u2018surname\u2019 box followed by the first word in the \u2018first name\u2019 box of the visa holder\u2019s travel document is written in that order. The issuing authority verifies that the name and first name which appear in the travel document and which are to be entered under this heading and in the section to be electronically scanned are the same as those appearing in the visa application. If the number of characters of the surname and first name exceeds the number of spaces available, the excess characters are replaced by a dot (.). (a) Mandatory entries to be added in the \u2018COMMENTS\u2019 section \u2014 in the case of a visa issued on behalf of another Member State pursuant to Article 8, the following mention is added: \u2018R/[Code of represented Member State]\u2019, \u2014 in the case of a visa issued for the purpose of transit, the following mention is added: \u2018TRANSIT\u2019; (b) National entries in \u2018COMMENTS\u2019 section This section also contains the comments in the language of the issuing Member State relating to national provisions. However, such comments shall not duplicate the mandatory comments referred to in point 1; (c) Section for the photograph The visa holder\u2019s photograph, in colour, shall be integrated in the space reserved for that purpose. The following rules shall be observed with respect to the photograph to be integrated into the visa sticker. The size of the head from chin to crown shall be between 70 % and 80 % of the vertical dimension of the surface of the photograph. The minimum resolution requirements shall be: \u2014 300 pixels per inch (ppi), uncompressed, for scanning, \u2014 720 dots per inch (dpi) for colour printing of photos. 10. Machine-readable zone This section is made up of two lines of 36 characters (OCR B-10 cpi). First line: 36 characters (mandatory) Positions Number of characters Heading contents Specifications 1-2 2 Type of document First character: V Second character: code indicating type of visa (A, C or D) 3-5 3 Issuing State ICAO alphabetic code 3-character: BEL, CHE, CZE, DNK, D<<, EST, GRC, ESP, FRA, ITA, LVA, LTU, LUX, HUN, MLT, NLD, AUT, POL, PRT, SVN, SVK, FIN, SWE, ISL, NOR 6-36 31 Surname and first name The surname should be separated from the first names by 2 symbols (<<); individual components of the name should be separated by one symbol (<); spaces which are not needed should be filled in with one symbol (<) Second line: 36 characters (mandatory) Positions Number of characters Heading contents Specifications 1 9 Visa number This is the number printed in the top right-hand corner of the sticker 10 1 Control character This character is the result of a complex calculation, based on the previous area according to an algorithm defined by the ICAO 11 3 Applicant\u2019s nationality Alphabetic coding according to ICAO 3-character codes 14 6 Date of birth The order followed is YYMMDD where: YY = year (mandatory) MM = month or << if unknown DD = day or << if unknown 20 1 Control character This character is the result of a complex calculation, based on the previous area according to an algorithm defined by the ICAO 21 1 Sex F = Female, M = Male, < = Not specified 22 6 Date on which the visa\u2019s validity ends The order followed is YYMMDD without a filler 28 1 Control character This character is the result of a complex calculation, based on the previous area according to an algorithm defined by the ICAO 29 1 Territorial validity (a) For LTV visas, insert the letter T (b) For uniform visas insert the filler < 30 1 Number of entries 1, 2, or M 31 2 Duration of stay (a) Short stay: number of days should be inserted in the visual reading area (b) Long stay: << 33 4 Start of validity The structure is MMDD without any filler. ANNEX VIII AFFIXING THE VISA STICKER 1. The visa sticker shall be affixed to the first page of the travel document that contains no entries or stamps \u2014 other than the stamp indicating that an application is admissible. 2. The sticker shall be aligned with and affixed to the edge of the page of the travel document. The machine-readable zone of the sticker shall be aligned with the edge of the page. 3. The stamp of the issuing authorities shall be placed in the \u2018COMMENTS\u2019 section in such a manner that it extends beyond the sticker onto the page of the travel document. 4. Where it is necessary to dispense with the completion of the section to be scanned electronically, the stamp may be placed in this section to render it unusable. The size and content of the stamp to be used shall be determined by the national rules of the Member State. 5. To prevent re-use of a visa sticker affixed to the separate sheet for affixing a visa, the seal of the issuing authorities shall be stamped to the right, straddling the sticker and the separate sheet, in such a way as neither to impede reading of the headings and the comments nor to enter the machine-readable zone. 6. The extension of a visa, pursuant to Article 33 of this Regulation, shall take the form of a visa sticker. The seal of the issuing authorities shall be affixed to the visa sticker. ANNEX IX PART 1 Rules for issuing visas at the border to seafarers in transit subject to visa requirements These rules relate to the exchange of information between the competent authorities of the Member States with respect to seafarers in transit subject to visa requirements. Insofar as a visa is issued at the border on the basis of the information that has been exchanged, the responsibility lies with the Member State issuing the visa. For the purposes of these rules: \u2018Member State port\u2019: means a port constituting an external border of a Member State; \u2018Member State airport\u2019: means an airport constituting an external border of a Member State. I. Signing on a vessel berthed or expected at a Member State port (entry into the territory of the Member States) \u2014 the shipping company or its agent shall inform the competent authorities at the Member State port where the ship is berthed or expected that seafarers subject to visa requirements are due to enter via a Member State airport, land or sea border. The shipping company or its agent shall sign a guarantee in respect of those seafarers that all expenses for the stay and, if necessary, for the repatriation of the seafarers will be covered by the shipping company, \u2014 those competent authorities shall verify as soon as possible whether the information provided by the shipping company or its agent is correct and shall examine whether the other conditions for entry into the territory of the Member States have been satisfied. The travel route within the territory of the Member States shall also be verified e.g. by reference to the (airline) tickets, \u2014 when seafarers are due to enter via a Member State airport, the competent authorities at the Member State port shall inform the competent authorities at the Member State airport of entry, by means of a duly completed form for seafarers in transit who are subject to visa requirements (as set out in Part 2), sent by fax, electronic mail or other means, of the results of the verification and shall indicate whether a visa may in principle be issued at the border. When seafarers are due to enter via a land or a sea border, the competent authorities at the border post via which the seafarer concerned enters the territory of the Member States shall be informed by the same procedure, \u2014 where the verification of the available data is positive and the outcome is clearly consistent with the seafarer\u2019s declaration or documents, the competent authorities at the Member State airport of entry or exit may issue a visa at the border the authorised stay of which shall correspond to what is necessary for the purpose of the transit. Furthermore, in such cases the seafarer\u2019s travel document shall be stamped with a Member State entry or exit stamp and given to the seafarer concerned. II. Leaving service from a vessel that has entered a Member State port (exit from the territory of the Member States) \u2014 the shipping company or its agent shall inform the competent authorities at that Member State port of entry of seafarers subject to visa requirements who are due to leave their service and exit from the Member States territory via a Member State airport, land or sea border. The shipping company or its agent shall sign a guarantee in respect of those seafarers that all expenses for the stay and, if necessary, for the repatriation costs of the seafarers will be covered by the shipping company, \u2014 the competent authorities shall verify as soon as possible whether the information provided by the shipping company or its agent is correct and shall examine whether the other conditions for entry into the territory of the Member States have been satisfied. The travel route within the territory of the Member States shall also be verified e.g. by reference to the (airline) tickets, \u2014 where the verification of the available data is positive, the competent authorities may issue a visa the authorised stay of which shall correspond to what is necessary for the purpose of the transit. III. Transferring from a vessel that entered a Member State port to another vessel \u2014 the shipping company or its agent shall inform the competent authorities at that Member State port of entry of seafarers subject to visa requirements who are due to leave their service and exit from the territory of the Member States via another Member State port. The shipping company or its agent shall sign a guarantee in respect of those seafarers that all expenses for the stay and, if necessary, for the repatriation of the seafarers will be covered by the shipping company, \u2014 the competent authorities shall verify as soon as possible whether the information provided by the shipping company or its agent is correct and shall examine whether the other conditions for entry into the territory of the Member States have been satisfied. The competent authorities at the Member State port from which the seafarers will leave the territory of the Member States by ship shall be contacted for the examination. A check shall be carried out to establish whether the ship they are joining is berthed or expected there. The travel route within the territory of the Member States shall also be verified, \u2014 where the verification of the available data is positive, the competent authorities may issue a visa the authorised stay of which shall correspond to what is necessary for the purpose of the transit. PART 2 DETAILED DESCRIPTION OF FORM Points 1-4: the identity of the seafarer (1) A. Surname(s) B. Forename(s) C. Nationality D. Rank/Grade (2) A. Place of birth B. Date of birth (3) A. Passport number B. Date of issue C. Period of validity (4) A. Seaman\u2019s book number B. Date of issue C. Period of validity As to points 3 and 4: depending on the nationality of the seafarer and the Member State being entered, a travel document or a seaman\u2019s book may be used for identification purposes. Points 5-8: the shipping agent and the vessel concerned (5) Name of shipping agent (the individual or corporation that represents the ship owner on the spot in all matters relating to the ship owner\u2019s duties in fitting out the vessel) under 5A and telephone number (and other contact details as fax number, electronic mail address) under 5B (6) A. Name of vessel B. IMO-number (this number consists of 7 numbers and is also known as \u2018Lloyds-number\u2019) C. Flag (under which the merchant vessel is sailing) (7) A. Date of arrival of vessel B. Origin (port) of vessel Letter \u2018A\u2019 refers to the vessel\u2019s date of arrival in the port where the seafarer is to sign on (8) A. Date of departure of vessel B. Destination of vessel (next port) As to points 7A and 8A: indications regarding the length of time for which the seafarer may travel in order to sign on. It should be remembered that the route followed is very much subject to unexpected interferences and external factors such as storms, breakdowns, etc. Points 9-12: purpose of the seafarer\u2019s journey and his destination (9) The \u2018final destination\u2019 is the end of the seafarer\u2019s journey. This may be either the port at which he is to sign on or the country to which he is heading if he is leaving service. (10) Reasons for application (a) In the case of signing on, the final destination is the port at which the seafarer is to sign on. (b) In the case of transfer to another vessel within the territory of the Member States, it is also the port at which the seafarer is to sign on. Transfer to a vessel situated outside the territory of the Member States must be regarded as leaving service. (c) In the case of leaving service, this can occur for various reasons, such as end of contract, accident at work, urgent family reasons, etc. (11) Means of transport List of means used within the territory of the Member States by the seafarer in transit who is subject to a visa requirement, in order to reach his final destination. On the form, the following three possibilities are envisaged: (a) car (or coach); (b) train; (c) aeroplane. (12) Date of arrival (on the territory of the Member States) Applies primarily to a seafarer at the first Member State airport or border crossing point (since it may not always be an airport) at the external border via which he wishes to enter the territory of the Member States. Date of transit This is the date on which the seafarer signs off at a port in the territory of the Member States and heads towards another port also situated in the territory of the Member States. Date of departure This is the date on which the seafarer signs off at a port in the territory of the Member States to transfer to another vessel at a port situated outside the territory of the Member States, or the date on which the seafarer signs off at a port in the territory of the Member States to return to his home (outside the territory of the Member States). After determining the three means of travel, available information should also be provided concerning those means: (a) car, coach: registration number; (b) train: name, number, etc.; (c) flight data: date, time, number. (13) Formal declaration signed by the shipping agent or the ship owner confirming his responsibility for the expenses for the stay and, if necessary, for the repatriation of the seafarer. ANNEX X LIST OF MINIMUM REQUIREMENTS TO BE INCLUDED IN THE LEGAL INSTRUMENT IN THE CASE OF COOPERATION WITH EXTERNAL SERVICE PROVIDERS A. In relation to the performance of its activities, the external service provider shall, with regard to data protection: (a) prevent at all times any unauthorised reading, copying, modification or deletion of data, in particular during their transmission to the diplomatic mission or consular post of the Member State(s) competent for processing an application; (b) in accordance with the instructions given by the Member State(s) concerned, transmit the data, \u2014 electronically, in encrypted form, or \u2014 physically, in a secured way; (c) transmit the data as soon as possible: \u2014 in the case of physically transferred data, at least once a week, \u2014 in the case of electronically transferred encrypted data, at the latest at the end of the day of their collection; (d) delete the data immediately after their transmission and ensure that the only data that might be retained shall be the name and contact details of the applicant for the purposes of the appointment arrangements, as well as the passport number, until the return of the passport to the applicant, where applicable; (e) ensure all the technical and organisational security measures required to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the cooperation involves the transmission of files and data to the diplomatic mission or consular post of the Member State(s) concerned and all other unlawful forms of processing personal data; (f) process the data only for the purposes of processing the personal data of applicants on behalf of the Member State(s) concerned; (g) apply data protection standards at least equivalent to those set out in Directive 95/46/EC; (h) provide applicants with the information required pursuant to Article 37 of the VIS Regulation. B. In relation to the performance of its activities, the external service provider shall, with regard to the conduct of staff: (a) ensure that its staff are appropriately trained; (b) ensure that its staff in the performance of their duties: \u2014 receive applicants courteously, \u2014 respect the human dignity and integrity of applicants, \u2014 do not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, and \u2014 respect the rules of confidentiality which shall also apply once members of staff have left their job or after suspension or termination of the legal instrument; (c) provide identification of the staff working for the external service provider at all times; (d) prove that its staff do not have criminal records and have the requisite expertise. C. In relation to the verification of the performance of its activities, the external service provider shall: (a) provide for access by staff entitled by the Member State(s) concerned to its premises at all times without prior notice, in particular for inspection purposes; (b) ensure the possibility of remote access to its appointment system for inspection purposes; (c) ensure the use of relevant monitoring methods (e.g. test applicants; webcam); (d) ensure access to proof of data protection compliance, including reporting obligations, external audits and regular spot checks; (e) report to the Member State(s) concerned without delay any security breaches or any complaints from applicants on data misuse or unauthorised access, and coordinate with the Member State(s) concerned in order to find a solution and give explanatory responses promptly to the complaining applicants. D. In relation to general requirements, the external service provider shall: (a) act under the instructions of the Member State(s) competent for processing the application; (b) adopt appropriate anti-corruption measures (e.g. provisions on staff remuneration; cooperation in the selection of staff members employed on the task; two-man-rule; rotation principle); (c) respect fully the provisions of the legal instrument, which shall contain a suspension or termination clause, in particular in the event of breach of the rules established, as well as a revision clause with a view to ensuring that the legal instrument reflects best practice. ANNEX XI SPECIFIC PROCEDURES AND CONDITIONS FACILITATING THE ISSUING OF VISAS TO MEMBERS OF THE OLYMPIC FAMILY PARTICIPATING IN THE OLYMPIC GAMES AND PARALYMPIC GAMES CHAPTER I Purpose and definitions Article 1 Purpose The following specific procedures and conditions facilitate the application for and issuing of visas to members of the Olympic family for the duration of the Olympic and Paralympic Games organised by a Member State. In addition, the relevant provisions of the Community acquis concerning procedures for applying for and issuing visas shall apply. Article 2 Definitions For the purposes of this Regulation: 1. \u2018Responsible organisations\u2019 relate to measures envisaged to facilitate the procedures for applying for and issuing visas for members of the Olympic family taking part in the Olympic and/or Paralympic Games, and they mean the official organisations, in terms of the Olympic Charter, which are entitled to submit lists of members of the Olympic family to the Organising Committee of the Member State hosting the Olympic and Paralympic Games with a view to the issue of accreditation cards for the Games; 2. \u2018Member of the Olympic family\u2019 means any person who is a member of the International Olympic Committee, the International Paralympic Committee, International Federations, the National Olympic and Paralympic Committees, the Organising Committees of the Olympic Games and the national associations, such as athletes, judges/referees, coaches and other sports technicians, medical personnel attached to teams or individual sportsmen/women and media-accredited journalists, senior executives, donors, sponsors or other official invitees, who agree to be guided by the Olympic Charter, act under the control and supreme authority of the International Olympic Committee, are included on the lists of the responsible organisations and are accredited by the Organising Committee of the Member State hosting the Olympic and Paralympic Games as participants in the [year] Olympic and/or Paralympic Games; 3. \u2018Olympic accreditation cards\u2019 which are issued by the Organising Committee of the Member State hosting the Olympic and Paralympic Games in accordance with its national legislation means one of two secure documents, one for the Olympic Games and one for the Paralympic Games, each bearing a photograph of its holder, establishing the identity of the member of the Olympic family and authorising access to the facilities at which competitions are held and to other events scheduled throughout the duration of the Games; 4. \u2018Duration of the Olympic Games and Paralympic Games\u2019 means the period during which the Olympic Games and the period during which the Paralympic Games take place; 5. \u2018Organising Committee of the Member State hosting the Olympic and Paralympic Games\u2019 means the Committee set up on by the hosting Member State in accordance with its national legislation to organise the Olympic and Paralympic Games, which decides on accreditation of members of the Olympic family taking part in those Games; 6. \u2018Services responsible for issuing visas\u2019 means the services designated by the Member State hosting the Olympic Games and Paralympic Games to examine applications and issue visas to members of the Olympic family. CHAPTER II Issuing of visas Article 3 Conditions A visa may be issued pursuant to this Regulation only where the person concerned: (a) has been designated by one of the responsible organisations and accredited by the Organising Committee of the Member State hosting the Olympic and Paralympic Games as a participant in the Olympic and/or Paralympic Games; (b) holds a valid travel document authorising the crossing of the external borders, as referred to in Article 5 of the Schengen Borders Code; (c) is not a person for whom an alert has been issued for the purpose of refusing entry; (d) is not considered to be a threat to public policy, national security or the international relations of any of the Member States. Article 4 Filing of the application 1. Where a responsible organisation draws up a list of the persons selected to take part in the Olympic and/or Paralympic Games, it may, together with the application for the issue of an Olympic accreditation card for the persons selected, file a collective application for visas for those persons selected who are required to be in possession of a visa in accordance with Regulation (EC) No 539/2001, except where those persons hold a residence permit issued by a Member State or a residence permit issued by the United Kingdom or Ireland, in accordance with Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States (1). 2. A collective application for visas for the persons concerned shall be forwarded at the same time as applications for the issue of an Olympic accreditation card to the Organising Committee of the Member State hosting the Olympic and Paralympic Games in accordance with the procedure established by it. 3. Individual visa applications shall be submitted for each person taking part in the Olympic and/or Paralympic Games. 4. The Organising Committee of the Member State hosting the Olympic and Paralympic Games shall forward to the services responsible for issuing visas, a collective application for visas as quickly as possible, together with copies of applications for the issue of an Olympic accreditation card for the persons concerned, bearing their full name, nationality, sex and date and place of birth and the number, type and expiry date of their travel document. Article 5 Examination of the collective application for visas and type of the visa issued 1. The visa shall be issued by the services responsible for issuing visas following an examination designed to ensure that the conditions set out in Article 3 are met. 2. The visa issued shall be a uniform, multiple-entry visa authorising a stay of not more than three months for the duration of the Olympic and/or Paralympic Games. 3. Where the member of the Olympic family concerned does not meet the conditions set out in point (c) or (d) of Article 3, the services responsible for issuing visas may issue a visa with limited territorial validity in accordance with Article 25 of this Regulation. Article 6 Form of the visa 1. The visa shall take the form of two numbers entered on the Olympic accreditation card. The first number shall be the visa number. In the case of a uniform visa, that number shall be made up of seven (7) characters comprising six (6) digits preceded by the letter \u2018C\u2019. In the case of a visa with limited territorial validity, that number shall be made up of eight (8) characters comprising six (6) digits preceded by the letters \u2018XX\u2019 (2). The second number shall be the number of the travel document of the person concerned. 2. The services responsible for issuing visas shall forward the visa numbers to the Organising Committee of the Member State hosting the Olympic and Paralympic Games for the purpose of issuing Olympic accreditation cards. Article 7 Waiver of fees The examination of visa applications and the issue of visas shall not give rise to any fees being charged by the services responsible for issuing visas. CHAPTER III General and final provisions Article 8 Cancellation of a visa Where the list of persons put forward as participants in the Olympic and/or Paralympic Games is amended before the Games begin, the responsible organisations shall inform without any delay the Organising Committee of the Member State hosting the Olympic and Paralympic Games thereof so that the Olympic accreditation cards of the persons removed from the list may be revoked. The Organising Committee shall notify the services responsible for issuing visas thereof and shall inform them of the numbers of the visas in question. The services responsible for issuing visas shall cancel the visas of the persons concerned. They shall immediately inform the authorities responsible for border checks thereof, and the latter shall without delay forward that information to the competent authorities of the other Member States. Article 9 External border checks 1. The entry checks carried out on members of the Olympic family who have been issued visas in accordance with this Regulation shall, when such members cross the external borders of the Member States, be limited to checking compliance with the conditions set out in Article 3. 2. For the duration of the Olympic and/or Paralympic Games: (a) entry and exit stamps shall be affixed to the first free page of the travel document of those members of the Olympic family for whom it is necessary to affix such stamps in accordance with Article 10(1) of the Schengen Borders Code. On first entry, the visa number shall be indicated on that same page; (b) the conditions for entry provided for in Article 5(1)(c) of the Schengen Borders Code shall be presumed to be fulfilled once a member of the Olympic family has been duly accredited. 3. Paragraph 2 shall apply to members of the Olympic family who are third-country nationals, whether or not they are subject to the visa requirement under Regulation (EC) No 539/2001. (1) OJ L 158, 30.4.2004, p. 77. (2) Reference to the ISO code of the organising Member State. ANNEX XII ANNUAL STATISTICS ON UNIFORM VISAS, VISAS WITH LIMITED TERRITORIAL VALIDITY AND AIRPORT TRANSIT VISAS Data to be submitted to the Commission within the deadline set out in Article 46 for each location where individual Member States issue visas: \u2014 total of A visas applied for (including multiple A visas), \u2014 total of A visas issued (including multiple A visas), \u2014 total of multiple A visas issued, \u2014 total of A visas not issued (including multiple A visas), \u2014 total of C visas applied for (including multiple-entry C visas), \u2014 total of C visas issued (including multiple-entry C visas), \u2014 total of multiple-entry C visas issued, \u2014 total of C visas not issued (including multiple-entry C visas), \u2014 total of LTV visas issued. General rules for the submission of data: \u2014 the data for the complete previous year shall be compiled in one single file, \u2014 the data shall be provided using the common template provided by the Commission, \u2014 data shall be available for the individual locations where the Member State concerned issue visas and grouped by third country, \u2014 \u2018Not issued\u2019 covers data on refused visas and applications where the examination has been discontinued as provided for in Article 8(2). In the event of data being neither available nor relevant for one particular category and a third country, Member States shall leave the cell empty (and not enter \u20180\u2019 (zero), \u2018N.A.\u2019 (non-applicable) or any other value). ANNEX XIII CORRELATION TABLE Provision of this Regulation Provision of the Schengen Convention (CSA), Common Consular Instructions (CCI) or of the Schengen Executive Committee (SCH/Com-ex) replaced TITLE I GENERAL PROVISIONS Article 1 Objective and scope CCI, Part I.1. Scope (CSA Articles 9 and 10) Article 2 Definitions (1)-(4) CCI: Part I. 2. Definitions and types of visas CCI: Part IV \u2018Legal basis\u2019 CSA: Articles 11(2), 14(1), 15, 16 TITLE II AIRPORT TRANSIT VISA Article 3 Third-country nationals required to hold an airport transit visa Joint Action 96/197/JHA, CCI, Part I. 2.1.1 TITLE III PROCEDURES AND CONDITIONS FOR ISSUING VISAS CHAPTER I Authorities taking part in the procedures relating to applications Article 4 Authorities competent for taking part in the procedures relating to applications CCI Part II. 4., CSA, Art. 12(1), Regulation (EC) No 415/2003 Article 5 Member State competent for examining and deciding on an application CCI, Part II 1.1(a) (b), CSA Article 12(2) Article 6 Consular territorial competence CCI, Part II, 1.1 and 3 Article 7 Competence to issue visas to third-country nationals legally present within the territory of a Member State \u2014 Article 8 Representation agreements CCI, Part II, 1.2 CHAPTER II Application Article 9 Practical modalities for lodging an application CCI, Annex 13, note (Article 10(1)) Article 10 General rules for lodging an application \u2014 Article 11 Application form CCI, Part III. 1.1. Article 12 Travel document CCI, Part III. 2. (a), CSA, Article 13(1) and (2) Article 13 Biometric identifiers CCI, Part III. 1.2 (a) and (b) Article 14 Supporting documents CCI, Part III.2(b) and Part V.1.4, Com-ex (98) 57 Article 15 Travel medical insurance CCI, Part V, 1.4 Article 16 Visa fee CCI Part VII. 4. and Annex 12 Article 17 Service fee CCI, Part VII, 1.7 CHAPTER III Examination of and decision on an application Article 18 Verification of consular competence \u2014 Article 19 Admissibility \u2014 Article 20 Stamp indicating that an application is admissible CCI, Part VIII, 2 Article 21 Verification of entry conditions and risk assessment CCI, Part III.4 and Part V.1. Article 22 Prior consultation of central authorities of other Member States CCI, Part II, 2.3 and Part V, 2.3(a)-(d) Article 23 Decision on the application CCI, Part V. 2.1 (second indent), 2.2, CCI CHAPTER IV Issuing of the visa Article 24 Issuing of a uniform visa CCI, Part V, 2.1 Article 25 Issuing of a visa with limited territorial validity CCI, Part V, 3, Annex 14, CSA 11(2), 14(1) and 16 Article 26 Issuing of an airport transit visa CCI, Part I, 2.1.1 \u2014 Joint Action 96/197/JHA Article 27 Filling in the visa sticker CCI, Part VI.1-2-3-4 Article 28 Invalidation of a completed visa sticker CCI, Part VI, 5.2 Article 29 Affixing a visa sticker CCI, Part VI, 5.3 Article 30 Rights derived from an issued visa CCI, Part I, 2.1, last sentence Article 31 Information of central authorities of other Member States \u2014 Article 32 Refusal of a visa \u2014 CHAPTER V Modification of an issued visa Article 33 Extension Com-ex (93) 21 Article 34 Annulment and revocation Com-ex (93) 24 and Annex 14 to the CCI CHAPTER VI Visas issued at the external borders Article 35 Visas applied for at the external border Regulation (EC) No 415/2003 Article 36 Visas issued to seafarers in transit at the external border TITLE IV ADMINISTRATIVE MANAGEMENT AND ORGANISATION Article 37 Organisation of visa sections CCI, VII, 1-2-3 Article 38 Resources for examining applications and monitoring of consulates \u2014 CCI, Part VII, 1A Article 39 Conduct of staff CCI, Part III.5 Article 40 Forms of cooperation CCI, Part VII, 1AA Article 41 Cooperation between Member States Article 42 Recourse to honorary consuls CCI, Part VII, AB Article 43 Cooperation with external service providers CCI, Part VII, 1B Article 44 Encryption and secure transfer of data CCI, Part II, 1.2, PART VII, 1.6, sixth, seventh, eighth and ninth subparagraphs Article 45 Member States\u2019 cooperation with commercial intermediaries CCI, VIII, 5.2 Article 46 Compilation of statistics SCH Com-ex (94) 25 and (98) 12 Article 47 Information to the general public \u2014 TITLE V LOCAL SCHENGEN COOPERATION Article 48 Local Schengen cooperation between Member States\u2019 consulates CCI, VIII, 1-3-4 TITLE VI FINAL PROVISIONS Article 49 Arrangements in relation to the Olympic Games and Paralympic Games \u2014 Articles 50 Amendments to the Annexes \u2014 Article 51 Instructions on the practical application of the Visa Code \u2014 Article 52 Committee procedure \u2014 Article 53 Notification \u2014 Article 54 Amendments to Regulation (EC) No 767/2008 \u2014 Article 55 Amendments to Regulation (EC) No 562/2006 \u2014 Article 56 Repeals \u2014 Article 57 Monitoring and evaluation \u2014 Article 58 Entry into force \u2014 ANNEXES Annex I Harmonised application form CCI, Annex 16 Annex II Non-exhaustive list of supporting documents Partially CCI, V, 1.4. Annex III Uniform format and use of the stamp indicating that a visa application is admissible CCI, VIII, 2 Annex IV Common list of third countries, listed in Annex I to Regulation (EC) No 539/2001whose nationals are required to be in possession of an airport transit visa when passing through the international transit area of airports situated on the territory of the Member States CCI, Annex 3, Part I Annex V List of residence permits entitling their holders to transit through the airports of Member States without being required to hold an airport transit visa CCI, Annex 3, Part III Annex VI Standard form for notifying and motivating refusal, annulment or revocation of a visa \u2014 Annex VII Filling in the visa sticker CCI, Part VI, 1-4, Annex 10 Annex VIII Affixing the visa sticker CCI, Part VI, 5.3 Annex IX Rules for issuing visas at the border to seafarers in transit subject to visa requirements Regulation (EC) No 415/2003, Annexes I and II Annex X List of minimum requirements to be included in the legal instrument in the case of cooperation with external service providers CCI, Annex 19 Annex XI Specific procedures and conditions facilitating the issuing of visas to members of the Olympic Family participating in the Olympic Games and Paralympic Games \u2014 Annex XII Annual statistics on uniform visas, visas with limited territorial validity and airport transit visas \u2014", "summary": "Visa Code Visa Code SUMMARY OF: Regulation (EC) No 810/2009 establishing the EU\u2019s Visa Code WHAT IS THE AIM OF THE REGULATION? It sets out procedures and conditions for issuing short-stay visas for visits to the Schengen area of no more than 90 days in any 180-day period. It also sets out rules on airport transit visas. KEY POINTS Procedures and conditions for issuing visas The European Union (EU) Member State that is the sole or main destination of the visit is responsible for examining the visa application. If the main destination cannot be determined, it becomes the responsibility of the country of first entry into the Schengen area. Applications A visa application may be submitted by the applicant, an accredited commercial intermediary or a professional, cultural, sports or educational association or institution on behalf of its members. Applications must generally be submitted within 6 months to 15 days of the intended visit (9 months for seafarers). A uniform visa (valid for the whole Schengen area) may be for multiple entries with a maximum validity of 5 years. A visa with limited territorial validity (limited to particular Member States) may exceptionally be issued in cases where the applicant does not fulfil all the entry conditions, on humanitarian grounds, for reasons of national interest, because of international obligations, or in situations where other Schengen countries consulted object to the issuing of a visa. Admissibility After verifying whether the application is admissible (i.e. submitted following the rules), the competent authority must: create an entry in the Visa Information System (VIS) under Regulation (EC) No 767/2008; carry out a further examination of the application to check that the applicant: fulfils the entry conditions as set out in Regulation (EU) 2016/399 setting out the Schengen Borders Code (see summary),does not pose a risk of illegal immigration or a threat to the security of the country, andintends to leave before the visa expires. Under amending Regulation (EU) 2021/1134, background checks on applicants would be reinforced before a decision is taken on granting a visa. Rules and procedures for searches in sensitive and non-sensitive EU databases containing security and migration information are set out. Once in effect, Member States would be required to collect biometric identifiers of the applicant comprising a facial image and 10 fingerprints (for storage in the VIS) and, at the time of submission of the first application and subsequently at least every 59 months thereafter, the applicant must appear in person. If the application is inadmissible, the authority would have to: return the application form and supporting documents without having examined them further; destroy any biometric data collected; and reimburse the visa fee. Airport transit visas Nationals of non-EU countries listed in Annex IV need an airport transit visa to pass through the international transit areas of airports in the Schengen area. In urgent cases of mass influx of illegal immigrants, any Member State may extend this requirement to nationals of other non-EU countries. When applying for an airport transit visa, the applicant must present proof of the points of departure and destination, coherence of the itinerary and proof of the onward journey to the final destination. Multiple-entry visas Multiple-entry visas with long validity may be issued for one, two or multiple entries. The Visa Code sets out rules on the issuing of multiple entry visas with a progressively longer length of validity: 1 year, if the applicant has used three visas within the previous 2 years; 2 years, if the applicant has already used a 1-year multiple-entry visa within the previous 2 years; 5 years, if the applicant has already used a 2-year multiple-entry visa within the previous 3 years. Airport transit visas and visas limited to particular countries are not taken into account when taking decisions on the issuing of multiple-entry visas with a long validity. Visas issued at the external borders Exceptionally, a visa application for a maximum stay of 15 days, or to cover the time needed for transit, may be applied for at the external border of the Schengen country of destination. A non-EU national for whom the verification of hits resulting from automated checks in EU databases has not been completed is not, in principle, issued a visa at the external border. However, a visa with limited territorial validity for the territory of the issuing Member State may be issued for such persons in exceptional cases. Decisions on visa applications The authority assesses whether the entry conditions set out in the Schengen Borders Code are met. A visa is refused if the applicant: presents a false travel document;gives inadequate justification for the intended stay;provides insufficient proof of means for the stay or for the return home;has been the subject of an alert in the Schengen information system set up under Regulation (EU) 2018/1860 (see summary) for the purpose of refusing entry;is considered a threat to the public policy, internal security, public health or internal relations of EU countries;presents insufficient travel medical insurance. The general deadline for a decision is a maximum of 15 days, which may be extended up to a maximum of 45 days in individual cases, notably where further scrutiny of the application is needed. A decision on refusal and the reasons on which it is based is notified to the applicant using the standard form set out in Annex VI. Persons whose visa has been refused have the right to appeal. Cooperation on readmission The European Commission assesses cooperation by non-EU countries on readmission of irregular migrants, taking into account border management and prevention, control of migrant smuggling and the transit of irregular migrants. Where a non-EU country is not cooperating, the Commission may submit a proposal for a Council decision to temporarily apply certain rules in a restrictive manner. Conversely, where a country is cooperating sufficiently, certain rules may be applied in a more generous manner. Respect for human dignity and fundamental rights Amending Regulation (EU) 2021/1134 also introduces stipulations that Member States\u2019 consular and central authorities\u2019 staff must fully respect human dignity and the fundamental rights and principles recognised by the EU\u2019s Charter of Fundamental Rights when performing their duties. They shall not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation. Amendments and repeals Amending Regulation (EU) 2021/1134 also amends the VIS regulation set up under Regulation (EC) No 767/2008 (see summary) and the Schengen Borders Code, as well as Articles 9\u201317 of the convention implementing the Schengen Agreement and the Common Consular Instructions. The regulation has been successively amended by Regulations (EU) No 977/2011, (EU) No 154/2012, (EU) No 610/2013, (EU) 2016/399, (EU) 2019/1155 and (EU) 2021/1134. FROM WHEN DOES THE REGULATION APPLY? Regulation (EC) No 810/2009 has applied since 5 April 2010. It should be noted that amendments introduced by Regulation (EU) 2021/1134 are expected to be applied only from 2024. BACKGROUND See also: Visa policy (European Commission). MAIN DOCUMENT Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, pp. 1\u201358). Successive amendments to Regulation (EC) No 810/2009 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2021/1134 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EC) No 767/2008, (EC) No 810/2009, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1860, (EU) 2018/1861, (EU) 2019/817 and (EU) 2019/1896 of the European Parliament and of the Council and repealing Council Decisions 2004/512/EC and 2008/633/JHA, for the purpose of reforming the Visa Information System (OJ L 248, 13.7.2021, pp. 11\u201387). Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312, 7.12.2018, pp. 1\u201313). See consolidated version. Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, pp. 14\u201355). See consolidated version. Regulation (EU) 2018/1806 of the European Parliament and of the Council of 14 November 2018 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (OJ L 303, 28.11.2018, pp. 39\u201358). See consolidated version. Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, pp. 1\u201371). See consolidated version. Regulation (EU) 2016/1953 of the European Parliament and of the Council of 26 October 2016 on the establishment of a European travel document for the return of illegally staying third-country nationals, and repealing the Council Recommendation of 30 November 1994 (OJ L 311, 17.11.2016, pp. 13\u201319). Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, pp. 1\u201352). See consolidated version. Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning the Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (VIS Regulation) (OJ L 218, 13.8.2008, pp. 60\u201381). See consolidated version. Regulation (EC) No 1987/2006 of the European Parliament and of the Council of 20 December 2006 on the establishment, operation and use of the second generation Schengen Information System (SIS II) (OJ L 381, 28.12.2006, pp. 4\u201323). See consolidated version. last update 11.11.2021"}
{"article": "13.8.2008 EN Official Journal of the European Union L 218/14 REGULATION (EC) No 763/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 on population and housing censuses (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof, Having regard to the proposal from the Commission, Acting in accordance with the procedure laid down in Article 251 of the Treaty (1), Whereas: (1) The Commission (Eurostat) needs to be in possession of sufficiently reliable, detailed and comparable data on the population and housing, in order to enable the Community to fulfil the tasks assigned to it, in particular by Articles 2 and 3 of the Treaty. Sufficient comparability must be ensured at Community level as regards methodology, definitions and the programme of the statistical data and the metadata. (2) Periodic statistical data on the population and the main family, social, economic and housing characteristics of persons are necessary for the study and definition of regional, social and environmental policies affecting particular sectors of the Community. In particular, there is a need to collect detailed information on housing in support of various Community activities, such as the promotion of social inclusion and the monitoring of social cohesion at regional level, or the protection of the environment and the promotion of energy efficiency. (3) In view of methodological and technological developments, best practices should be identified and the enhancement of the data sources and methodologies used for censuses in the Member States should be fostered. (4) In order to ensure the comparability of the data provided by the Member States and for reliable overviews to be drawn up at Community level, the data used should refer to the same reference year. (5) In accordance with Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (2), which constitutes the reference framework for the provisions of this Regulation, it is necessary for the collection of statistics to conform to the principles of impartiality, in particular objectivity and scientific independence, as well as transparency, reliability, relevance, cost-effectiveness and statistical confidentiality. (6) The transmission of data subject to statistical confidentiality is governed by Regulation (EC) No 322/97 and Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (3). Measures that are taken in accordance with those Regulations ensure the physical and logical protection of confidential data and that no unlawful disclosure or non-statistical use occurs when Community statistics are produced and disseminated. (7) In the production and dissemination of Community statistics under this Regulation, the national and Community statistical authorities should take account of the principles set out in the European Statistics Code of Practice adopted on 24 February 2005 by the Statistical Programme Committee, established by Council Decision 89/382/EEC, Euratom (4) and attached to the Recommendation of the Commission on the independence, integrity and accountability of the national and Community statistical authorities. (8) Since the objectives of this Regulation, namely the collection and compilation of comparable and comprehensive Community statistics on population and housing, cannot be sufficiently achieved by the Member States, due to the absence of common statistical features and quality requirements as well as a lack of methodological transparency, and can therefore, by way of a common statistical framework, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (9) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5). (10) In particular, the Commission should be empowered to establish the conditions for the establishment of subsequent reference years and the adoption of the programme of the statistical data and the metadata. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (11) The Statistical Programme Committee has been consulted in accordance with Article 3 of Decision 89/382/EEC, Euratom, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes common rules for the decennial provision of comprehensive data on population and housing. Article 2 Definitions For the purpose of this Regulation, the following definitions shall apply: (a) \u2018population\u2019 shall mean the national, regional and local population at its usual residence at the reference date; (b) \u2018housing\u2019 shall mean living quarters and buildings as well as housing arrangements and the relationship between the population and living quarters at the national, regional and local levels at the reference date; (c) \u2018buildings\u2019 shall mean permanent buildings that contain living quarters designed for human habitation, or conventional dwellings that are reserved for seasonal or secondary use or that are vacant; (d) \u2018usual residence\u2019 shall mean the place where a person normally spends the daily period of rest, regardless of temporary absences for purposes of recreation, holidays, visits to friends and relatives, business, medical treatment or religious pilgrimage. The following persons alone shall be considered to be usual residents of the geographical area in question: (i) those who have lived in their place of usual residence for a continuous period of at least 12 months before the reference date; or (ii) those who arrived in their place of usual residence during the 12 months before the reference date with the intention of staying there for at least one year. Where the circumstances described in point (i) or (ii) cannot be established, \u2018usual residence\u2019 shall mean the place of legal or registered residence; (e) \u2018reference date\u2019 shall mean the date to which the data of the respective Member State refer, in accordance with Article 5(1); (f) \u2018national\u2019 shall mean on the territory of a Member State; (g) \u2018regional\u2019 shall mean at NUTS level 1, NUTS level 2 or NUTS level 3, as defined in the classification of territorial units for statistics (NUTS), established by Regulation (EC) No 1059/2003 of the European Parliament and of the Council (6) in its version applicable at the reference date; (h) \u2018local\u2019 shall mean at Local Administrative Units level 2 (LAU level 2); (i) \u2018essential features of population and housing censuses\u2019 shall mean individual enumeration, simultaneity, universality within a defined territory, availability of small-area data and defined periodicity. Article 3 Data submission Member States shall submit to the Commission (Eurostat) data on the population covering determined demographic, social and economic characteristics of persons, families and households, as well as on housing at a national, regional and local level, as set out in the Annex. Article 4 Data sources 1. Member States may base the statistics on different data sources, in particular on: (a) conventional censuses; (b) register-based censuses; (c) a combination of conventional censuses and sample surveys; (d) a combination of register-based censuses and sample surveys; (e) a combination of register-based censuses and conventional censuses; (f) a combination of register-based censuses, sample surveys and conventional censuses; and (g) appropriate surveys with rotating samples (rolling censuses). 2. Member States shall take all measures necessary to meet the requirements of data protection. The Member States' own data protection provisions shall not be affected by this Regulation. 3. Member States shall inform the Commission (Eurostat) of any revision or correction of the statistics supplied under this Regulation, as well as of any changes in the chosen data sources and methodology, no later than one month before the release of the revised data. 4. Member States shall ensure that the data sources and the methodology used to satisfy the requirements of this Regulation meet, to the highest possible extent, the essential features of population and housing censuses, as defined in Article 2(i). They shall make continuous efforts to enhance compliance with those essential features. Article 5 Data transmission 1. Each Member State shall determine a reference date. The reference date shall fall in a year specified on the basis of this Regulation (reference year). The first reference year shall be 2011. The Commission (Eurostat) shall establish subsequent reference years in accordance with the regulatory procedure with scrutiny referred to in Article 8(3). Reference years shall fall during the beginning of every decade. 2. Member States shall provide the Commission (Eurostat) with final, validated and aggregated data and with metadata, as required by this Regulation, within 27 months of the end of the reference year. 3. The Commission (Eurostat) shall adopt a programme of the statistical data and of the metadata to be transmitted to fulfil the requirements of this Regulation, in accordance with the regulatory procedure with scrutiny referred to in Article 8(3). 4. The Commission (Eurostat) shall adopt the technical specifications of the topics as required by this Regulation as well as of their breakdowns, in accordance with the regulatory procedure referred to in Article 8(2). 5. Member States shall transmit to the Commission (Eurostat) the validated data and metadata in electronic form. The Commission (Eurostat) shall adopt the appropriate technical format to be used for the transmission of the required data, in accordance with the regulatory procedure referred to in Article 8(2). 6. In the event of a revision or correction in accordance with Article 4(3), Member States shall transmit the modified data to the Commission (Eurostat) no later than on the date of release of the revised data. Article 6 Quality assessment 1. For the purpose of this Regulation, the following quality assessment dimensions shall apply to the data to be transmitted: \u2014 \u2018relevance\u2019 shall refer to the degree to which statistics meet the current and potential needs of users, \u2014 \u2018accuracy\u2019 shall refer to the closeness of estimates to the unknown true values, \u2014 \u2018timeliness\u2019 and \u2018punctuality\u2019 shall refer to the delay between the reference period and the availability of results, \u2014 \u2018accessibility\u2019 and \u2018clarity\u2019 shall refer to the conditions under and modalities by which users can obtain, use and interpret data, \u2014 \u2018comparability\u2019 shall refer to the measurement of the impact of differences in applied statistical concepts and measurement tools and procedures when statistics are compared between geographical areas, sectoral domains, or over time, and \u2014 \u2018coherence\u2019 shall refer to the adequacy of the data to be reliably combined in different ways and for various uses. 2. Member States shall provide the Commission (Eurostat) with a report on the quality of the data transmitted. In this context, Member States shall report on the extent to which the chosen data sources and methodology meet the essential features of population and housing censuses as defined in Article 2(i). 3. In applying the quality assessment dimensions laid down in paragraph 1 to the data covered by this Regulation, the modalities and structure of the quality reports shall be defined in accordance with the regulatory procedure referred to in Article 8(2). The Commission (Eurostat) shall assess the quality of the data transmitted. 4. The Commission (Eurostat), in cooperation with the competent authorities of the Member States, shall provide methodological recommendations designed to ensure the quality of the data and metadata produced, acknowledging, in particular, the Conference of European Statisticians Recommendations for the 2010 Censuses of Population and Housing. Article 7 Implementing measures 1. The following measures necessary for the implementation of this Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 8(2): (a) technical specifications of the topics as required by this Regulation as well as of their breakdowns as provided for in Article 5(4); (b) the establishment of the appropriate technical format as provided for in Article 5(5); and (c) modalities and structure of the quality reports as provided for in Article 6(3). 2. The following measures necessary for the implementation of this Regulation, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 8(3): (a) the establishment of the reference years, as provided for in Article 5(1); and (b) the adoption of the programme of the statistical data and the metadata, as provided for in Article 5(3). 3. Consideration shall be given to the principles that the benefits of the measures taken must outweigh their costs and that additional costs and burdens must remain within a reasonable limit. Article 8 Committee procedure 1. The Commission shall be assisted by the Statistical Programme Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 9 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 July 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J.-P. JOUYET (1) Opinion of the European Parliament of 20 February 2008 (not yet published in the Official Journal) and Council Decision of 23 June 2008. (2) OJ L 52, 22.2.1997, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). (3) OJ L 151, 15.6.1990, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003. (4) OJ L 181, 28.6.1989, p. 47. (5) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (6) OJ L 154, 21.6.2003, p. 1. Regulation as last amended by Regulation (EC) No 176/2008 of the European Parliament and of the Council (OJ L 61, 5.3.2008, p. 1). ANNEX Topics to be covered in Population and Housing Censuses 1. Population topics 1.1. Obligatory topics for the geographical levels: NUTS 3, LAU 2 1.1.1. Non-derived topics \u2014 Place of usual residence, \u2014 sex, \u2014 age, \u2014 legal marital status, \u2014 country/place of birth, \u2014 country of citizenship, \u2014 previous place of usual residence and date of arrival in the current place; or place of usual residence one year prior to the census, \u2014 relationships between household members 1.1.2. Derived topics \u2014 Total population, \u2014 locality, \u2014 household status, \u2014 family status, \u2014 type of family nucleus, \u2014 size of family nucleus, \u2014 type of private household, \u2014 size of private household 1.2. Obligatory topics for the geographical levels: national level, NUTS 1, NUTS 2 1.2.1. Non-derived topics \u2014 Place of usual residence, \u2014 location of place of work, \u2014 sex, \u2014 age, \u2014 legal marital status, \u2014 current activity status, \u2014 occupation, \u2014 industry (branch of economic activity), \u2014 status in employment, \u2014 educational attainment, \u2014 country/place of birth, \u2014 country of citizenship, \u2014 ever resided abroad and year of arrival in the country (from 1980), \u2014 previous place of usual residence and date of arrival in the current place; or place of usual residence one year prior to the census, \u2014 relationships between household members, \u2014 tenure status of households 1.2.2. Derived topics \u2014 Total population, \u2014 locality, \u2014 household status, \u2014 family status, \u2014 type of family nucleus, \u2014 size of family nucleus, \u2014 type of private household, \u2014 size of private household 2. Housing topics 2.1. Obligatory topics for the geographical levels: NUTS 3, LAU 2 2.1.1. Non-derived topics \u2014 Type of living quarters, \u2014 location of living quarters, \u2014 occupancy status of conventional dwellings, \u2014 number of occupants, \u2014 useful floor space and/or number of rooms of housing units, \u2014 dwellings by type of building, \u2014 dwellings by period of construction 2.1.2. Derived topics \u2014 Density standard 2.2. Obligatory topics for the geographical levels: national level, NUTS 1, NUTS 2 2.2.1. Non-derived topics \u2014 Housing arrangements, \u2014 type of living quarters, \u2014 location of living quarters, \u2014 occupancy status of conventional dwellings, \u2014 type of ownership, \u2014 number of occupants, \u2014 useful floor space and/or number of rooms of housing units, \u2014 water supply system, \u2014 toilet facilities, \u2014 bathing facilities, \u2014 type of heating, \u2014 dwellings by type of building, \u2014 dwellings by period of construction 2.2.2. Derived topics \u2014 Density standard", "summary": "Common rules for the collection of census data on population and housing Common rules for the collection of census data on population and housing SUMMARY OF Regulation (EC) No 763/2008 on population and housing censuses WHAT IS THE AIM OF THIS REGULATION? It sets out common rules for the provision of census statistics on population and housing in the EU. It aims to achieve comprehensive and flexible dissemination of census data as well as transparency regarding their quality. KEY POINTS Data submission EU countries are required to submit to the European Commission (Eurostat) data on the population covering: various demographic, social and economic characteristics of persons, families and households; housing at a national, regional and local level. These data are as set out in the regulation\u2019s annex and its implementing regulations. Data sources The regulation sets out the data sources on which EU countries must base their statistics. These include: conventional censuses; register-based censuses; a combination of conventional censuses and sample surveys; a combination of register-based censuses and sample surveys; a combination of register-based censuses and conventional censuses; a combination of register-based censuses, sample surveys and conventional censuses; and appropriate surveys with rotating samples (rolling censuses). Data protection EU countries must take all measures necessary to meet the requirements of data protection. Their own data protection rules are not affected by this regulation. Data transmission Each EU country must determine a date to which its data refer (a reference date), which must fall in the reference year. The first reference year is 2011. Reference years fall on the first year of each decade. EU countries must inform Eurostat of any revision or correction of the statistics transmitted as well as of any changes in the chosen data sources and methodology. This must be done no later than 1 month before the release of the revised data. EU countries must provide Eurostat with final, validated and aggregated data and metadata within 27 months of the end of the reference year. To fulfil the requirements of this regulation, in 2010 the European Commission adopted a first programme of the statistical data and of the metadata to be transmitted for the reference year 2011 and, in 2017, it adopted a second programme for the reference year 2021. EU countries transmit to Eurostat the data in accordance with the EU law on data transmission subject to statistical confidentiality as set out in Regulation (EC) No 223/2009. They must ensure that the transmitted data do not permit the direct identification of the statistical units. Transmission is in electronic format and is in accordance with the specifications agreed by the European Statistical System Committee, the committee that assists and advises the Commission (Eurostat). Quality assessment EU countries must ensure that the data sources and the methodology used to satisfy the requirements of the regulation meet the essential features of population and housing censuses as laid down in the regulation, i.e.: individual enumeration, simultaneity, universality within a defined territory, availability of small-area data, and defined periodicity. EU countries must provide Eurostat with a report on the quality of the data transmitted, outlining the extent to which the chosen data sources and methodology meet the essential features of population and housing censuses. The Commission assesses the quality of the data transmitted. In cooperation with the EU countries\u2019 competent authorities, it provides methodological recommendations designed to ensure the quality of the data and the metadata produced, in particular acknowledging the Conference of European Statisticians \u2014 Recommendations for the 2010 Censuses of Population and Housing. FROM WHEN DOES THE REGULATION APPLY? It has applied since 2 September 2008. BACKGROUND For the EU to be able to develop its regional, social and environmental policies, it needs to have at its disposal comparable and reliable data on population and the main family, social, economic and housing characteristics of persons. For more information, see: Population and housing census \u2014 Overview (Eurostat) Population and housing census \u2014 2011 Census (Eurostat). MAIN DOCUMENT Regulation (EC) No 763/2008 of the European Parliament and of the Council of 9 July 2008 on population and housing censuses (OJ L 218, 13.8.2008, pp. 14-20) RELATED DOCUMENTS Commission Implementing Regulation (EU) 2017/881 of 23 May 2017 implementing Regulation (EC) No 763/2008 of the European Parliament and of the Council on population and housing censuses, as regards the modalities and structure of the quality reports and the technical format for data transmission, and amending Regulation (EU) No 1151/2010 (OJ L 135, 24.5.2017, pp. 6-14) Commission Regulation (EU) 2017/712 of 20 April 2017 establishing the reference year and the programme of the statistical data and metadata for population and housing censuses provided for by Regulation (EC) No 763/2008 of the European Parliament and of the Council (OJ L 105, 21.4.2017, pp. 1-11) Commission Implementing Regulation (EU) 2017/543 of 22 March 2017 laying down rules for the application of Regulation (EC) No 763/2008 of the European Parliament and of the Council on population and housing censuses as regards the technical specifications of the topics and of their breakdowns (OJ L 78, 23.3.2017, pp. 13-58) Commission Regulation (EU) No 1151/2010 of 8 December 2010 implementing Regulation (EC) No 763/2008 of the European Parliament and of the Council on population and housing censuses, as regards the modalities and structure of the quality reports and the technical format for data transmission (OJ L 324, 9.12.2010, pp. 1-12) Successive amendments to Regulation (EU) No 1151/2010 have been incorporated into the original document. This consolidated version is of documentary value only. Commission Regulation (EU) No 519/2010 of 16 June 2010 adopting the programme of the statistical data and of the metadata for population and housing censuses provided for by Regulation (EC) No 763/2008 of the European Parliament and of the Council (OJ L 151, 17.6.2010, pp. 1-13) Commission Regulation (EC) No 1201/2009 of 30 November 2009 implementing Regulation (EC) No 763/2008 of the European Parliament and of the Council on population and housing censuses as regards the technical specifications of the topics and of their breakdowns (OJ L 329, 15.12.2009, pp. 29-68) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, pp. 164-173) See consolidated version. last update 07.11.2017"}
{"article": "22.11.2019 EN Official Journal of the European Union L 302/1 RULES OF PROCEDURE 9th parliamentary term July 2019 Note to the reader: In accordance with Parliament's decisions on the use of gender-neutral language in its documents, the Rules of Procedure have been adapted to take account of the guidelines on that subject approved by the High Level Group on Gender Equality and Diversity on 11 April 2018. Interpretations of the Rules (pursuant to Rule 236) are shown in italic script. CONTENTS TITLE I MEMBERS, PARLIAMENT BODIES AND POLITICAL GROUPS 11 CHAPTER 1 MEMBERS OF THE EUROPEAN PARLIAMENT 11 Rule 1 European Parliament 11 Rule 2 Independent mandate 12 Rule 3 Verification of credentials 12 Rule 4 Term of office of Members 13 Rule 5 Privileges and immunities 13 Rule 6 Waiver of immunity 14 Rule 7 Defence of privileges and immunity 14 Rule 8 Urgent action by the President to assert immunity 15 Rule 9 Procedures on immunity 15 Rule 10 Standards of conduct 16 Rule 11 Members' financial interests and Transparency register 17 Rule 12 Internal investigations conducted by the European Anti-Fraud Office (OLAF) 18 Rule 13 Observers 18 CHAPTER 2 OFFICERS OF PARLIAMENT 18 Rule 14 Provisional Chair 18 Rule 15 Nominations and general provisions 18 Rule 16 Election of President \u2014 opening address 19 Rule 17 Election of Vice-Presidents 19 Rule 18 Election of Quaestors 19 Rule 19 Term of office of Officers 19 Rule 20 Vacancies 20 Rule 21 Early termination of an office 20 CHAPTER 3 BODIES AND DUTIES 20 Rule 22 Duties of the President 20 Rule 23 Duties of the Vice-Presidents 20 Rule 24 Composition of the Bureau 21 Rule 25 Duties of the Bureau 21 Rule 26 Composition of the Conference of Presidents 22 Rule 27 Duties of the Conference of Presidents 22 Rule 28 Duties of the Quaestors 23 Rule 29 Conference of Committee Chairs 23 Rule 30 Conference of Delegation Chairs 23 Rule 31 Continuity of an office during the election period 23 Rule 32 Accountability of the Bureau and the Conference of Presidents 23 CHAPTER 4 POLITICAL GROUPS 23 Rule 33 Establishment and dissolution of political groups 23 Rule 34 Activities and legal situation of the political groups 24 Rule 35 Intergroups 25 Rule 36 Non-attached Members 25 Rule 37 Allocation of seats in the Chamber 25 TITLE II LEGISLATIVE, BUDGETARY, DISCHARGE AND OTHER PROCEDURES 26 CHAPTER 1 LEGISLATIVE PROCEDURES \u2014 GENERAL PROVISIONS 26 Rule 38 Annual programming 26 Rule 39 Respect for fundamental rights 26 Rule 40 Verification of legal basis 27 Rule 41 Delegation of legislative powers and conferral of implementing powers 27 Rule 42 Verification of financial compatibility 27 Rule 43 Examination of respect for the principles of subsidiarity and proportionality 28 Rule 44 Access to documents and provision of information to Parliament 28 Rule 45 Representation of Parliament in Council meetings 28 Rule 46 Right of Parliament to submit proposals 28 Rule 47 Requests to the Commission for submission of proposals 29 Rule 48 Consideration of legally binding acts 29 Rule 49 Acceleration of legislative procedures 30 Rule 50 Legislative procedures on initiatives originating from institutions other than the Commission or from Member States 30 CHAPTER 2 PROCEDURE IN COMMITTEE 30 Rule 51 Legislative reports 30 Rule 52 Simplified procedure 31 Rule 53 Non-legislative reports 31 Rule 54 Own-initiative reports 31 Rule 55 Drafting of reports 32 Rule 56 Opinions of committees 32 Rule 57 Associated committee procedure 33 Rule 58 Joint committee procedure 34 CHAPTER 3 ORDINARY LEGISLATIVE PROCEDURE 34 SECTION 1 \u2014 FIRST READING 34 Rule 59 Vote in Parliament \u2014 first reading 34 Rule 60 Referral back to the committee responsible 35 Rule 61 Renewed referral to Parliament 36 Rule 62 First-reading agreement 36 SECTION 2 \u2014 SECOND READING 36 Rule 63 Communication of the Council's position 36 Rule 64 Extension of time limits 36 Rule 65 Procedure in the committee responsible 37 Rule 66 Submission to Parliament 37 Rule 67 Vote in Parliament \u2014 second reading 37 Rule 68 Admissibility of amendments to the Council's position 38 Rule 69 Second-reading agreement 38 SECTION 3 \u2014 INTERINSTITUTIONAL NEGOTIATIONS DURING THE ORDINARY LEGISLATIVE PROCEDURE 39 Rule 70 General provisions 39 Rule 71 Negotiations ahead of Parliament's first reading 39 Rule 72 Negotiations ahead of Council's first reading 39 Rule 73 Negotiations ahead of Parliament's second reading 39 Rule 74 Conduct of negotiations 40 SECTION 4 \u2014 CONCILIATION AND THIRD READING 40 Rule 75 Extension of time limits 40 Rule 76 Convening of the Conciliation Committee 40 Rule 77 Delegation to the Conciliation Committee 40 Rule 78 Joint text 41 SECTION 5 \u2014 CONCLUSION OF THE PROCEDURE 41 Rule 79 Signing and publication of adopted acts 41 CHAPTER 4 PROVISIONS SPECIFIC TO THE CONSULTATION PROCEDURE 41 Rule 80 Modified proposal for a legally binding act 41 Rule 81 Commission position on amendments 42 Rule 82 Vote in Parliament 42 Rule 83 Follow-up to Parliament's position 42 Rule 84 Renewed referral to Parliament 42 CHAPTER 5 CONSTITUTIONAL MATTERS 42 Rule 85 Ordinary Treaty revision 42 Rule 86 Simplified Treaty revision 43 Rule 87 Accession treaties 43 Rule 88 Withdrawal from the Union 43 Rule 89 Breach by a Member State of fundamental principles and values 44 Rule 90 Composition of Parliament 44 Rule 91 Enhanced cooperation between Member States 44 CHAPTER 6 BUDGETARY PROCEDURES 45 Rule 92 Multiannual financial framework 45 Rule 93 Annual budgetary procedure 45 Rule 94 Parliament's position on the draft budget 45 Rule 95 Budgetary conciliation 46 Rule 96 Definitive adoption of the budget 46 Rule 97 Provisional twelfths system 46 Rule 98 Implementation of the budget 47 Rule 99 Discharge to the Commission in respect of implementation of the budget 47 Rule 100 Other discharge procedures 47 Rule 101 Interinstitutional cooperation 47 CHAPTER 7 INTERNAL BUDGETARY PROCEDURES 47 Rule 102 Estimates of Parliament 47 Rule 103 Procedure to be applied when drawing up Parliament's estimates 48 Rule 104 Power to incur and settle expenditure, to approve accounts and to grant discharge 48 CHAPTER 8 CONSENT PROCEDURE 48 Rule 105 Consent procedure 48 CHAPTER 9 OTHER PROCEDURES 49 Rule 106 Procedure for delivering opinions on derogations to the adoption of the euro 49 Rule 107 Procedures relating to dialogue between management and labour 49 Rule 108 Procedures for scrutiny of envisaged voluntary agreements 49 Rule 109 Codification 50 Rule 110 Recasting 50 CHAPTER 10 DELEGATED AND IMPLEMENTING ACTS 51 Rule 111 Delegated acts 51 Rule 112 Implementing acts and measures 52 Rule 113 Consideration under the associated committee procedure or the joint committee procedure 53 TITLE III EXTERNAL RELATIONS 53 CHAPTER 1 INTERNATIONAL AGREEMENTS 53 Rule 114 International agreements 53 Rule 115 Provisional application or suspension of the application of international agreements or establishment of the Union's position in a body set up by an international agreement 54 CHAPTER 2 EXTERNAL REPRESENTATION OF THE UNION AND THE COMMON FOREIGN AND SECURITY POLICY 55 Rule 116 Special representatives 55 Rule 117 International representation 55 CHAPTER 3 RECOMMENDATIONS ON THE UNION'S EXTERNAL ACTION 55 Rule 118 Recommendations on the Union's external policies 55 Rule 119 Consultation of, and provision of information to, Parliament within the framework of the common foreign and security policy 56 Rule 120 Breach of human rights 56 TITLE IV TRANSPARENCY OF BUSINESS 56 Rule 121 Transparency of Parliament's activities 56 Rule 122 Public access to documents 56 Rule 123 Access to Parliament 57 TITLE V RELATIONS WITH OTHER INSTITUTIONS AND BODIES 58 CHAPTER 1 APPOINTMENTS 58 Rule 124 Election of the President of the Commission 58 Rule 125 Election of the Commission 58 Rule 126 Multiannual programming 59 Rule 127 Motion of censure on the Commission 59 Rule 128 Nomination of Judges and Advocates-General at the Court of Justice of the European Union 60 Rule 129 Appointment of the Members of the Court of Auditors 60 Rule 130 Appointment of the Members of the Executive Board of the European Central Bank 60 Rule 131 Appointments to the economic governance bodies 60 CHAPTER 2 STATEMENTS 61 Rule 132 Statements by the Commission, Council and European Council 61 Rule 133 Statements explaining Commission decisions 61 Rule 134 Statements by the Court of Auditors 62 Rule 135 Statements by the European Central Bank 62 CHAPTER 3 PARLIAMENTARY QUESTIONS 62 Rule 136 Questions for oral answer with debate 62 Rule 137 Question Time 63 Rule 138 Questions for written answer 63 Rule 139 Major interpellations for written answer 64 Rule 140 Questions for written answer to the European Central Bank 64 Rule 141 Questions for written answer concerning the Single Supervisory Mechanism and the Single Resolution Mechanism 64 CHAPTER 4 REPORTS OF OTHER INSTITUTIONS AND BODIES 65 Rule 142 Annual and other reports of other institutions or bodies 65 CHAPTER 5 RESOLUTIONS AND RECOMMENDATIONS 65 Rule 143 Motions for resolutions 65 Rule 144 Debates on cases of breaches of human rights, democracy and the rule of law 66 CHAPTER 6 CONSULTATION OF OTHER INSTITUTIONS AND BODIES 67 Rule 145 Consultation of the European Economic and Social Committee 67 Rule 146 Consultation of the Committee of the Regions 67 Rule 147 Requests to European Agencies 67 CHAPTER 7 INTERINSTITUTIONAL AGREEMENTS 67 Rule 148 Interinstitutional agreements 67 CHAPTER 8 REFERRALS TO THE COURT OF JUSTICE OF THE EUROPEAN UNION 68 Rule 149 Proceedings before the Court of Justice of the European Union 68 TITLE VI RELATIONS WITH NATIONAL PARLIAMENTS 69 Rule 150 Exchange of information, contacts and reciprocal facilities 69 Rule 151 Conference of Parliamentary Committees for Union Affairs (COSAC) 69 Rule 152 Conferences of parliaments 69 TITLE VII SESSIONS 70 CHAPTER 1 SESSIONS OF PARLIAMENT 70 Rule 153 Parliamentary term, sessions, part-sessions, sittings 70 Rule 154 Convening of Parliament 70 Rule 155 Venue of sittings and meetings 70 Rule 156 Attendance of Members at sittings 70 CHAPTER 2 ORDER OF BUSINESS OF PARLIAMENT 71 Rule 157 Draft agenda 71 Rule 158 Adopting and amending the agenda 71 Rule 159 Procedure in plenary without amendment and debate 71 Rule 160 Short presentation 72 Rule 161 Extraordinary debate 72 Rule 162 Topical debate requested by a political group 72 Rule 163 Urgent procedure 73 Rule 164 Joint debate 73 Rule 165 Time limits 73 CHAPTER 3 GENERAL RULES FOR THE CONDUCT OF SITTINGS 73 Rule 166 Access to the Chamber 73 Rule 167 Languages 73 Rule 168 Transitional arrangement 74 Rule 169 Distribution of documents 74 Rule 170 Electronic handling of documents 74 Rule 171 Allocation of speaking time and list of speakers 74 Rule 172 One-minute speeches 75 Rule 173 Personal statements 76 Rule 174 Prevention of obstruction 76 CHAPTER 4 MEASURES TO BE TAKEN IN THE EVENT OF NON-COMPLIANCE WITH THE STANDARDS OF CONDUCT OF MEMBERS 76 Rule 175 Immediate measures 76 Rule 176 Penalties 77 Rule 177 Internal appeal procedures 78 CHAPTER 5 QUORUM, AMENDMENTS AND VOTING 78 Rule 178 Quorum 78 Rule 179 Thresholds 78 Rule 180 Tabling and presenting amendments 79 Rule 181 Admissibility of amendments 80 Rule 182 Voting procedure 81 Rule 183 Order of voting on amendments 81 Rule 184 Committee filter of plenary amendments 82 Rule 185 Split voting 82 Rule 186 Right to vote 82 Rule 187 Voting 82 Rule 188 Final vote 83 Rule 189 Tied votes 83 Rule 190 Voting by roll call 83 Rule 191 Voting by secret ballot 84 Rule 192 Use of electronic voting system 84 Rule 193 Disputes on voting 84 Rule 194 Explanations of votes 84 CHAPTER 6 POINTS OF ORDER AND PROCEDURAL MOTIONS 85 Rule 195 Points of order 85 Rule 196 Procedural motions 85 Rule 197 Motions calling for a matter to be declared inadmissible 86 Rule 198 Referral back to committee 86 Rule 199 Closure of a debate 86 Rule 200 Adjournment of a debate or vote 86 Rule 201 Suspension or closure of the sitting 87 CHAPTER 7 PUBLIC RECORD OF PROCEEDINGS 87 Rule 202 Minutes 87 Rule 203 Texts adopted 87 Rule 204 Verbatim reports 88 Rule 205 Audiovisual record of proceedings 88 TITLE VIII COMMITTEES AND DELEGATIONS 88 CHAPTER 1 COMMITTEES 88 Rule 206 Setting-up of standing committees 88 Rule 207 Special committees 88 Rule 208 Committees of inquiry 89 Rule 209 Composition of committees 90 Rule 210 Duties of committees 91 Rule 211 Questions of competence 91 Rule 212 Subcommittees 91 Rule 213 Committee bureaux 91 Rule 214 Committee coordinators 92 Rule 215 Shadow Rapporteurs 92 Rule 216 Committee meetings 92 Rule 217 Minutes of committee meetings 93 Rule 218 Voting in committee 93 Rule 219 Provisions concerning plenary sittings applicable in committee 93 Rule 220 Question Time in committee 93 Rule 221 Procedure for the consultation by a committee of confidential information in a committee meeting in camera 94 Rule 222 Public hearings and debates on citizens' initiatives 94 CHAPTER 2 INTERPARLIAMENTARY DELEGATIONS 95 Rule 223 Setting-up and duties of interparliamentary delegations 95 Rule 224 Joint parliamentary committees 96 Rule 225 Cooperation with the Parliamentary Assembly of the Council of Europe 96 TITLE IX PETITIONS 96 Rule 226 Right of petition 96 Rule 227 Examination of petitions 98 Rule 228 Fact-finding visits 98 Rule 229 Notice of petitions 99 Rule 230 Citizens' initiative 99 TITLE X OMBUDSMAN 99 Rule 231 Election of the Ombudsman 99 Rule 232 Activities of the Ombudsman 100 Rule 233 Dismissal of the Ombudsman 100 TITLE XI PARLIAMENT'S SECRETARIAT 101 Rule 234 Parliament's Secretariat 101 TITLE XII POWERS AND RESPONSIBILITIES RELATING TO EUROPEAN POLITICAL PARTIES AND EUROPEAN POLITICAL FOUNDATIONS 101 Rule 235 Powers and responsibilities relating to European political parties and European political foundations 101 TITLE XIII APPLICATION AND AMENDMENT OF THE RULES OF PROCEDURE 102 Rule 236 Application of the Rules of Procedure 102 Rule 237 Amendment of the Rules of Procedure 103 TITLE XIV MISCELLANEOUS PROVISIONS 103 Rule 238 The symbols of the Union 103 Rule 239 Gender Mainstreaming 103 Rule 240 Unfinished business 103 Rule 241 Corrigenda 104 ANNEX I CODE OF CONDUCT FOR MEMBERS OF THE EUROPEAN PARLIAMENT WITH RESPECT TO FINANCIAL INTERESTS AND CONFLICTS OF INTEREST 105 ANNEX II CODE OF APPROPRIATE BEHAVIOUR FOR MEMBERS OF THE EUROPEAN PARLIAMENT IN EXERCISING THEIR DUTIES 109 ANNEX III CRITERIA FOR QUESTIONS FOR WRITTEN ANSWER UNDER RULES 138, 140 AND 141 110 ANNEX IV GUIDELINES AND GENERAL PRINCIPLES TO BE FOLLOWED WHEN CHOOSING THE SUBJECTS TO BE INCLUDED ON THE AGENDA FOR THE DEBATE ON CASES OF BREACHES OF HUMAN RIGHTS, DEMOCRACY AND THE RULE OF LAW PROVIDED FOR UNDER RULE 144 111 ANNEX V PROCEDURE FOR THE CONSIDERATION AND ADOPTION OF DECISIONS ON THE GRANTING OF DISCHARGE 112 ANNEX VI POWERS AND RESPONSIBILITIES OF STANDING COMMITTEES 115 ANNEX VII APPROVAL OF THE COMMISSION AND MONITORING OF COMMITMENTS MADE DURING THE HEARINGS 124 ANNEX VIII REQUIREMENTS FOR THE DRAFTING OF ACTS ADOPTED IN ACCORDANCE WITH THE ORDINARY LEGISLATIVE PROCEDURE 128 TITLE I MEMBERS, PARLIAMENT BODIES AND POLITICAL GROUPS CHAPTER 1 Members of the European Parliament Rule 1 European Parliament 1. The European Parliament is the assembly elected pursuant to the Treaties, the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage and national legislation deriving from the Treaties. 2. Persons elected to the European Parliament shall be referred to as: \u2018\u0427\u043b\u0435\u043d\u043e\u0432\u0435 \u043d\u0430 \u0415\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u044f \u043f\u0430\u0440\u043b\u0430\u043c\u0435\u043d\u0442\u2019 in Bulgarian, \u2018Diputados al Parlamento Europeo\u2019 in Spanish, \u2018Poslanci Evropsk\u00e9ho parlamentu\u2019 in Czech, \u2018Medlemmer af Europa-Parlamentet\u2019 in Danish, \u2018Mitglieder des Europ\u00e4ischen Parlaments\u2019 in German, \u2018Euroopa Parlamendi liikmed\u2019 in Estonian, \u2018\u0392o\u03c5\u03bb\u03b5\u03c5\u03c4\u03ad\u03c2 \u03c4o\u03c5 \u0395\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03bao\u03cd \u039ao\u03b9vo\u03b2o\u03c5\u03bb\u03afo\u03c5\u2019 in Greek, \u2018Members of the European Parliament\u2019 in English, \u2018D\u00e9put\u00e9s au Parlement europ\u00e9en\u2019 in French, \u2018Feisir\u00ed de Pharlaimint na hEorpa\u2019 in Irish, \u2018Zastupnici u Europskom parlamentu\u2019 in Croatian, \u2018Deputati al Parlamento europeo\u2019 in Italian, \u2018Eiropas Parlamenta deput\u0101ti\u2019 in Latvian, \u2018Europos Parlamento nariai\u2019 in Lithuanian, \u2018Eur\u00f3pai Parlamenti K\u00e9pvisel\u0151k\u2019 in Hungarian, \u2018Membri tal-Parlament Ewropew\u2019 in Maltese, \u2018Leden van het Europees Parlement\u2019 in Dutch, \u2018Pos\u0142owie do Parlamentu Europejskiego\u2019 in Polish, \u2018Deputados ao Parlamento Europeu\u2019 in Portuguese, \u2018Deputa\u0163i \u00een Parlamentul European\u2019 in Romanian, \u2018Poslanci Eur\u00f3pskeho parlamentu\u2019 in Slovak, \u2018Poslanci Evropskega parlamenta\u2019 in Slovenian, \u2018Euroopan parlamentin j\u00e4senet\u2019 in Finnish, \u2018Ledam\u00f6ter av Europaparlamentet\u2019 in Swedish. Rule 2 Independent mandate In accordance with Article 6(1) of the Act of 20 September 1976 and with Article 2(1) and Article 3(1) of the Statute for Members of the European Parliament, Members shall exercise their mandate freely and independently, shall not be bound by any instructions and shall not receive a binding mandate. Rule 3 Verification of credentials 1. Following general elections to the European Parliament, the President shall invite the competent authorities of the Member States to notify Parliament without delay of the names of the elected Members so that all Members may take their seats in Parliament with effect from the opening of the first sitting following the elections. At the same time, the President shall draw the attention of those authorities to the relevant provisions of the Act of 20 September 1976 and invite them to take the necessary measures to avoid any incompatibility with the office of Member of the European Parliament. 2. Members whose election has been notified to Parliament shall declare in writing, before taking their seat in Parliament, that they do not hold any office incompatible with that of Member of the European Parliament within the meaning of Article 7(1) or (2) of the Act of 20 September 1976. Following general elections, the declaration shall be made, where possible, no later than six days prior to Parliament's first sitting following the elections. Until such time as Members' credentials have been verified or a ruling has been given on any dispute, and provided that they have previously signed the above-mentioned written declaration, they shall take their seat in Parliament and on its bodies and shall enjoy all the rights attaching thereto. Where it is established from facts verifiable from sources available to the public that a Member holds an office incompatible with that of Member of the European Parliament, within the meaning of Article 7(1) or (2) of the Act of 20 September 1976, Parliament, on the basis of the information provided by its President, shall establish that there is a vacancy. 3. On the basis of a report by the committee responsible, Parliament shall verify credentials without delay and rule on the validity of the mandate of each of its newly elected Members and also on any disputes referred to it pursuant to the provisions of the Act of 20 September 1976, other than those which, under that Act, fall exclusively under the national provisions to which that Act refers. The committee's report shall be based on the official notification by each Member State of the full results of the election, specifying the names of the candidates elected and those of any substitutes, together with their ranking in accordance with the results of the vote. The validity of the mandate of a Member may not be confirmed unless the written declarations required under this Rule and Annex I to these Rules of Procedure have been made. 4. On the basis of a proposal by the committee responsible, Parliament shall, without delay, verify the credentials of individual Members who are replacing outgoing Members and may at any time rule on any dispute as to the validity of the mandate of any of its Members. 5. Where the appointment of a Member is due to the withdrawal of candidates from the same list, the committee responsible shall ensure that the withdrawal in question has taken place in accordance with the spirit and the letter of the Act of 20 September 1976 and Rule 4(2). 6. The committee responsible shall ensure that any information which may affect the eligibility of the Member or the eligibility or the ranking of the substitutes is forwarded to Parliament without delay by the authorities of the Member States or of the Union, with, in the case of an appointment, an indication of the date on which it will take effect. Should the competent authorities of the Member States initiate a procedure which might lead to the disqualification of a Member from holding office, the President shall ask them to keep him or her regularly informed of the stage reached in the procedure and shall refer the matter to the committee responsible. On a proposal from that committee, Parliament may adopt a position on the matter. Rule 4 Term of office of Members 1. A Member's term of office begins and ends as laid down in Articles 5 and 13 of the Act of 20 September 1976. 2. Members who resign shall notify the President of their resignation and of the date on which that resignation is to take effect, which may not be more than three months after notification. This notification shall take the form of an official record drawn up in the presence of the Secretary-General or his or her representative, signed by the latter and by the Member concerned and immediately submitted to the committee responsible, which shall enter it on the agenda of its first meeting following receipt of the document. If the committee responsible considers that the resignation is in compliance with the Act of 20 September 1976, a vacancy shall be declared with effect from the date indicated by the resigning Member in the official record, and the President shall inform Parliament thereof. If the committee responsible considers that the resignation is not in compliance with the Act of 20 September 1976, it shall propose to Parliament that it not declare a vacancy. 3. Where no meeting of the committee responsible is scheduled before the next part-session, the rapporteur of the committee responsible shall immediately examine any resignation that has been duly notified. Where delay in considering the notification would be prejudicial, the rapporteur shall refer the matter to the committee Chair, requesting, pursuant to paragraph 2, that: \u2014 the President be informed on behalf of the committee that a vacancy may be declared, or \u2014 an extraordinary meeting of the committee be convened to examine specific difficulties noted by the rapporteur. 4. Where either the competent authorities of the Member States or of the Union or the Member concerned notifies the President of an appointment or election to an office that is incompatible with the office of Member of the European Parliament within the meaning of Article 7(1) or (2) of the Act of 20 September 1976, the President shall inform Parliament thereof, and Parliament shall declare that a vacancy exists from the date of the incompatibility. Where the competent authorities of the Member States notify the President of the end of the term of office of a Member of the European Parliament as a result either of an additional incompatibility established by the law of that Member State in accordance with Article 7(3) of the Act of 20 September 1976 or of the withdrawal of the Member's mandate pursuant to Article 13(3) of that Act, the President shall inform Parliament that the term of office of that Member ended on the date communicated by competent authorities of the Member State. Where no such date is communicated, the date of the end of the term of office shall be the date of the notification by that Member State. 5. Where the authorities of the Member States or of the Union inform the President of an assignment they intend to entrust to a Member, the President shall refer to the committee responsible the question of the compatibility of the proposed assignment with the Act of 20 September 1976 and shall inform Parliament, the Member and the authorities concerned of the conclusions reached by that committee. 6. When Parliament has established a vacancy, the President shall inform the Member State concerned thereof, and invite it to fill the seat without delay. 7. Where acceptance or termination of office appears to be based on material inaccuracy or vitiated consent, Parliament may declare the appointment under consideration to be invalid or may refuse to establish the vacancy. Rule 5 Privileges and immunities 1. Members enjoy the privileges and immunities laid down in the Protocol No 7 on the Privileges and Immunities of the European Union. 2. In exercising its powers on privileges and immunities, Parliament shall act to uphold its integrity as a democratic legislative assembly and to ensure the independence of its Members in the performance of their duties. Parliamentary immunity is not a Member's personal privilege but a guarantee of the independence of Parliament as a whole, and of its Members. 3. A laissez-passer of the European Union allowing a Member to circulate freely in the Member States and in other countries which recognise it as a valid travel document shall be issued by the European Union to a Member at his or her request, on condition that the President of the Parliament gives his or her authorisation. 4. For the purpose of performing their parliamentary duties, all Members shall have the right to participate actively in the work of Parliament's committees and delegations in accordance with the provisions of these Rules of Procedure. 5. Members shall be entitled to inspect any files held by Parliament or a committee, other than personal files and accounts, which only the Members concerned shall be allowed to inspect. Exceptions to this rule, concerning the handling of documents to which public access may be denied, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council (1), are laid down in Rule 221. With the approval of the Bureau, a Member may, on the basis of a reasoned decision, be denied the right to inspect a Parliament document if, after hearing the Member concerned, the Bureau comes to the conclusion that such an inspection would cause unacceptable damage to Parliament's institutional interests or to the public interest, and that the Member concerned is seeking to inspect the document for private and personal reasons. The Member may lodge a written appeal against such a decision within one month of the notification thereof. In order to be admissible, written appeals must include reasons. Parliament shall reach a decision on the appeal without debate during the part-session that follows its lodging. Access to confidential information is subject to the rules laid down in interinstitutional agreements concluded by Parliament relating to the treatment of confidential information (2) and to the internal rules for their implementation adopted by Parliament's competent bodies (3). Rule 6 Waiver of immunity 1. Any request for waiver of immunity shall be evaluated in accordance with Articles 7, 8 and 9 of the Protocol No 7 on the Privileges and Immunities of the European Union and with the principles referred to in Rule 5(2). 2. Where Members are required to appear as witnesses or expert witnesses, there is no need to request a waiver of immunity, provided: \u2014 that they will not be obliged to appear on a date or at a time which prevents them from performing their parliamentary duties, or makes it difficult for them to perform those duties, or that they will be able to provide a statement in writing or in any other form which does not make it difficult for them to perform their parliamentary duties, and \u2014 that they are not obliged to testify concerning information obtained confidentially in the performance of their parliamentary duties which they do not see fit to disclose. Rule 7 Defence of privileges and immunity 1. In cases where it is alleged that an infringement of the privileges and immunities of a Member or former Member by the authorities of a Member State has occurred or is about to occur, a request for a Parliament decision as to whether those privileges and immunities have been or are likely to be breached may be made in accordance with Rule 9(1). 2. In particular, such a request for the defence of privileges and immunities may be made if it is considered that the circumstances would constitute an administrative or other restriction on the free movement of Members travelling to or from the place of meeting of Parliament or an administrative or other restriction on an opinion expressed or a vote cast in the performance of their duties, or that the circumstances would fall within the scope of Article 9 of the Protocol No 7 on the Privileges and Immunities of the European Union. 3. A request for the defence of the privileges and immunities of a Member shall not be admissible if a request for the waiver or defence of that Member's immunity has already been received in respect of the same facts, whether or not that earlier request led to a decision. 4. No further consideration shall be given to a request for the defence of the privileges and immunities of a Member if a request for the waiver of that Member's immunity is received in respect of the same facts. 5. In cases where a decision has been taken not to defend the privileges and immunities of a Member, the Member may exceptionally make a request for reconsideration of the decision, by submitting new evidence in accordance with Rule 9(1). The request for reconsideration shall be inadmissible if proceedings have been instituted against the decision under Article 263 of the Treaty on the Functioning of the European Union, or if the President considers that the new evidence submitted is insufficiently substantiated to warrant reconsideration. Rule 8 Urgent action by the President to assert immunity 1. As a matter of urgency, in circumstances where a Member is arrested or has his or her freedom of movement curtailed in apparent breach of his or her privileges and immunities, the President may, after consulting the Chair and rapporteur of the committee responsible, take an initiative to assert the privileges and immunities of the Member concerned. The President shall notify the committee of that initiative and inform Parliament. 2. When the President makes use of the powers conferred on him or her by paragraph 1, the committee shall take cognisance of the President's initiative at its next meeting. Where the committee deems it necessary, it may prepare a report for submission to Parliament. Rule 9 Procedures on immunity 1. Any request addressed to the President by a competent authority of a Member State for the immunity of a Member to be waived, or by a Member or a former Member for privileges and immunities to be defended, shall be announced in Parliament and referred to the committee responsible. 2. With the agreement of the Member or the former Member concerned, the request may be made by another Member, who shall be permitted to represent the Member or former Member concerned at all stages of the procedure. The Member representing the Member or the former Member concerned shall not be involved in the decisions taken by the committee. 3. The committee shall consider, without delay but having regard to their relative complexity, requests for the waiver of immunity or requests for the defence of privileges and immunities. 4. The committee shall make a proposal for a reasoned decision which recommends the adoption or rejection of the request for the waiver of immunity or for the defence of privileges and immunities. Amendments shall not be admissible. If a proposal is rejected, the contrary decision shall be deemed to have been adopted. 5. The committee may ask the authority concerned to provide any information or explanation which the committee deems necessary in order for it to form an opinion on whether immunity should be waived or defended. 6. The Member concerned shall be given an opportunity to be heard and may present any documents or other written evidence deemed by that Member to be relevant. The Member concerned shall not be present during debates on the request for waiver or defence of his or her immunity, except for the hearing itself. The Chair of the committee shall invite the Member to be heard, indicating a date and time. The Member concerned may renounce the right to be heard. If the Member concerned fails to attend the hearing pursuant to that invitation, he or she shall be deemed to have renounced the right to be heard, unless he or she has asked to be excused from being heard on the date and at the time proposed, and has given his or her reasons. The Chair of the committee shall rule on whether such a request to be excused is to be accepted in view of the reasons given. The Member concerned shall not be permitted to appeal that ruling. If the Chair of the committee grants the request to be excused, he or she shall invite the Member concerned to be heard at a new date and time. If the Member concerned fails to comply with the second invitation to be heard, the procedure shall continue without the Member being heard. No further requests to be excused, or to be heard, may then be accepted. 7. Where the request seeks the waiver or the defence of immunity on several counts, each of these may be the subject of a separate decision. The committee's report may, exceptionally, propose that the waiver or the defence of immunity should apply solely to prosecution proceedings and that, until a final sentence is passed, the Member should be immune from any form of detention or remand or any other measure which prevents that Member from performing the duties proper to the mandate. 8. The committee may offer a reasoned opinion as to the competence of the authority in question and the admissibility of the request, but shall not, under any circumstances, pronounce on the guilt, or otherwise, of the Member, nor shall it pronounce on whether or not the opinions or acts attributed to the Member justify prosecution, even if the committee, in considering the request, acquires detailed knowledge of the facts of the case. 9. The committee's proposal for a decision shall be placed on the agenda of the first sitting following the day on which it was tabled. No amendments may be tabled to such a proposal. Discussion shall be confined to the reasons for and against each proposal to waive or uphold immunity, or to defend a privilege or immunity. Without prejudice to Rule 173, the Member whose privileges or immunities are under consideration shall not speak in the debate. The proposal or proposals for a decision contained in the report shall be put to the vote at the first voting time following the debate. After Parliament has considered the matter, a separate vote shall be taken on each of the proposals contained in the report. If a proposal is rejected, the contrary decision shall be deemed to have been adopted. 10. The President shall immediately communicate Parliament's decision to the Member concerned and to the competent authority of the Member State concerned, with a request that the President be informed of any developments and judicial rulings in the relevant proceedings. When the President receives this information, he or she shall transmit it to Parliament in the way he or she considers most appropriate, if necessary after consulting the committee responsible. 11. The committee shall treat these matters, and handle any documents received with the utmost confidentiality. The committee shall always consider requests relating to procedures on immunity in camera. 12. Parliament shall only examine requests for the waiver of a Member's immunity that have been transmitted to it by the judicial authorities or by the Permanent Representations of the Member States. 13. The committee shall lay down principles for the application of this Rule. 14. Any inquiry as to the scope of Members' privileges or immunities made by a competent authority shall be dealt with in accordance with the above rules. Rule 10 Standards of conduct 1. The conduct of Members shall be characterised by mutual respect and shall be based on the values and principles laid down in the Treaties, and particularly in the Charter of Fundamental Rights. Members shall respect Parliament's dignity and shall not harm its reputation. 2. Members shall not compromise the smooth conduct of parliamentary business and shall not compromise the maintenance of security and order on Parliament's premises or the functioning of its equipment. 3. Members shall not disrupt the good order of the Chamber and shall refrain from improper behaviour. They shall not display banners. 4. In parliamentary debates in the Chamber, Members shall not resort to offensive language. The assessment of whether the language used by a Member in a parliamentary debate is offensive or not should take into consideration, inter alia, the identifiable intentions of the speaker, the perception of the statement by the public, the extent to which it harms the dignity and reputation of Parliament, and the freedom of speech of the Member concerned. By way of example, defamatory language, \u2018hate speech\u2019 and incitement to discrimination based, in particular, on any ground referred to in Article 21 of the Charter of Fundamental Rights, would ordinarily constitute cases of \u2018offensive language\u2019 within the meaning of this Rule. 5. Members shall comply with Parliament's rules on the treatment of confidential information. 6. Members shall refrain from any type of psychological or sexual harassment and shall respect the Code of appropriate behaviour for Members of the European Parliament in exercising their duties which is attached to these Rules of Procedure as an annex (4). Members may not be elected as office-holders of Parliament or one of its bodies, be appointed as rapporteur or participate in an official delegation or interinstitutional negotiations, if they have not signed the declaration relating to that Code. 7. Where a person working for a Member, or another person for whom the Member has arranged access to Parliament's premises or equipment, fails to comply with the standards of conduct set out in this Rule, this behaviour may, where appropriate, be imputable to the Member concerned. 8. The application of this Rule shall not otherwise detract from the liveliness of parliamentary debates, nor shall it undermine Members' freedom of speech. 9. This Rule shall apply, mutatis mutandis, in Parliament's bodies, committees and delegations. Rule 11 Members' financial interests and Transparency register 1. Parliament shall lay down rules governing the transparency of its Members' financial interests in the form of a Code of Conduct which shall be adopted by a majority of its component Members and attached to these Rules of Procedure as an annex (5). Those rules shall not otherwise prejudice or restrict Members in the exercise of their office or of any related political or other activity. 2. Members should adopt the systematic practice of only meeting interest representatives that have registered in the Transparency Register established by means of the Agreement between the European Parliament and the European Commission (6). 3. Members should publish online all scheduled meetings with interest representatives falling under the scope of the Transparency register. Without prejudice to Article 4(6) of Annex I, rapporteurs, shadow rapporteurs and committee chairs shall, for each report, publish online all scheduled meetings with interest representatives falling under the scope of the Transparency register. The Bureau shall provide for necessary infrastructure on Parliament's website. 4. The Bureau shall provide the necessary infrastructure on Members' online page on Parliament's website for those Members who wish to publish a voluntary audit or confirmation, as provided for under the applicable rules of the Statute for Members and its implementing rules, that their use of the General Expenditure Allowance complies with the applicable rules of the Statute for Members and its implementing measures. 5. These rules shall not otherwise prejudice or restrict Members in the exercise of their office or of any related political or other activity. 6. The code of conduct and the rights and privileges of former Members shall be laid down by a decision of the Bureau. No distinction shall be made in the treatment of former Members. Rule 12 Internal investigations conducted by the European Anti-Fraud Office (OLAF) The common rules laid down in the Interinstitutional Agreement concerning internal investigations by the European Anti-Fraud Office (OLAF) (7) comprising the measures that are needed to facilitate the smooth running of investigations conducted by the Office shall be applicable within Parliament, pursuant to Parliament Decision of 18 November 1999 (8). Rule 13 Observers 1. Where a Treaty on the accession of a State to the European Union has been signed, the President may, after obtaining the agreement of the Conference of Presidents, invite the parliament of the acceding State to appoint, from among its own members, a number of observers equal to the number of seats in the European Parliament to be allocated to that State upon accession. 2. Those observers shall take part in the proceedings of Parliament pending the entry into force of the Treaty of Accession, and shall have a right to speak in committees and political groups. They shall not have the right to vote or to stand for election to positions in Parliament, nor shall they represent the Parliament externally. Their participation shall not have any legal effect on Parliament's proceedings. 3. Their treatment shall be assimilated to that of a Member as regards the use of Parliament's facilities and the reimbursement of travel and subsistence expenses incurred in their activities as observers. CHAPTER 2 Officers of Parliament Rule 14 Provisional Chair (9) 1. At the sitting provided for under Rule 154(2), and at any other sitting held for the purpose of electing the President and the Bureau, the outgoing President or, failing him or her, one of the outgoing Vice-Presidents, determined in accordance with their order of precedence, or, in the absence of any of them, the Member having held office for the longest period shall take the chair until the President has been elected. 2. No business shall be transacted while a Member is provisionally in the chair by virtue of paragraph 1 unless it concerns the election of the President or the verification of credentials under the second subparagraph of Rule 3(2). Any other matter relating to the verification of credentials raised when he or she is in the chair shall be referred to the committee responsible. Rule 15 Nominations and general provisions (10) 1. The President shall be elected by secret ballot, followed by the Vice-Presidents and the Quaestors, in accordance with Rule 191. Nominations shall be with consent of the nominee, and may only be made by a political group or Members reaching at least the low threshold. New nominations may be handed in before each ballot. If the number of nominations does not exceed the number of seats to be filled, the candidates shall be elected by acclamation, unless Members or a political group or groups reaching at least the high threshold request a secret ballot. In the event of a single ballot for more than one officer, the ballot paper shall only be valid if more than half of the available votes have been cast. 2. When electing the President, Vice-Presidents and Quaestors, account should be taken of the need to ensure an overall fair representation of political views, as well as gender and geographical balance. Rule 16 Election of President \u2014 opening address (11) 1. Nominations for President shall be handed to the Member provisionally in the chair by virtue of Rule 14, who shall announce them to Parliament. If after three ballots no candidate has obtained an absolute majority of the votes cast, the fourth ballot shall, by way of derogation from Rule 15(1), be confined to the two Members who have obtained the highest number of votes in the third ballot. In the event of a tie, the older candidate shall be declared to have been elected. 2. As soon as the President has been elected, the Member who is provisionally in the chair by virtue of Rule 14 shall vacate the chair. Only the elected President may deliver an opening address. Rule 17 Election of Vice-Presidents 1. The Vice-Presidents shall then be elected on a single ballot. Those who on the first ballot, up to the number of 14, secure an absolute majority of the votes cast shall be declared to have been elected in order of the number of votes obtained. If the number of candidates elected is less than the number of seats to be filled, a second ballot shall be held under the same conditions to fill the remaining seats. If a third ballot is necessary, a relative majority shall suffice for election to the remaining seats. In the event of a tie, the oldest candidates shall be declared to have been elected. 2. Subject to the provisions of Rule 20(1), the Vice-Presidents shall take precedence in the order in which they were elected and, in the event of a tie, by age. If Vice-Presidents are elected by acclamation, a secret ballot shall be held to determine their order of precedence. Rule 18 Election of Quaestors Parliament shall elect five Quaestors by the same procedure as that used for the election of the Vice-Presidents. Rule 19 Term of office of Officers (12) 1. The term of office of the President, Vice-Presidents and Quaestors shall be two-and-a-half years. When Members change political groups they shall retain, for the remainder of their two-and-a- half-year term of office, any seat they hold in the Bureau or as Quaestors. 2. If a vacancy for one of these positions occurs before the expiry of this term of office, the Member elected shall serve only the remaining period of his or her predecessor's term of office. Rule 20 Vacancies (13) 1. If it becomes necessary for the President, a Vice-President or a Quaestor to be replaced, a successor shall be elected in accordance with the respective rules for elections to the office concerned. A newly elected Vice-President shall take the place of his or her predecessor in the order of precedence. 2. If the office of President becomes vacant, a Vice-President, determined in accordance with the order of precedence, shall act as President until a new President is elected. Rule 21 Early termination of an office The Conference of Presidents may, acting by a majority of three-fifths of the votes cast, representing at least three political groups, propose to Parliament that it bring to an end the term of office of the President, a Vice-President, a Quaestor, a Chair or Vice-Chair of a committee, a Chair or Vice-Chair of an interparliamentary delegation, or of any other office holder elected within the Parliament, where it considers that the Member in question has been guilty of serious misconduct. Parliament shall take a decision on that proposal by a majority of two-thirds of the votes cast, constituting a majority of its component Members. Where a rapporteur breaches the provisions of the Code of Conduct for Members of the European Parliament with respect to financial interests and conflicts of interest (14), the committee which appointed him or her may, at the initiative of the President and on a proposal by the Conference of Presidents, terminate the holding of that office. The majorities laid down in the first paragraph shall apply mutatis mutandis to each stage of this procedure. CHAPTER 3 Bodies and duties Rule 22 Duties of the President 1. The President shall direct all the activities of Parliament and its bodies in accordance with these Rules and shall enjoy all powers that are necessary to preside over the proceedings of Parliament and to ensure that they are properly conducted. 2. The duties of the President shall be to open, suspend and close sittings; to rule on the admissibility of amendments and other texts put to the vote, as well as on the admissibility of parliamentary questions; to ensure observance of these Rules; to maintain order; to call upon speakers; to close debates; to put matters to the vote and to announce the results of votes; as well as to refer to committees any communications that concern them. 3. The President may speak in a debate only to sum up or to call speakers to order. Should the President wish to take part in a debate, he or she shall vacate the chair and shall not reoccupy it until the debate is over. 4. Parliament shall be represented in international relations, on ceremonial occasions and in administrative, legal and financial matters by the President, who may delegate these powers. 5. The President is responsible for the security and the inviolability of the premises of the European Parliament. Rule 23 Duties of the Vice-Presidents 1. If the President is absent or unable to discharge his or her duties, or if the President wishes to take part in a debate pursuant to Rule 22(3), he or she shall be replaced by one of the Vice-Presidents determined in accordance with the order of precedence. 2. The Vice-Presidents shall also carry out the duties conferred upon them under Rules 25, 27(3) and (5), and 77(3). 3. The President may delegate any duties to the Vice-Presidents, such as representing Parliament at specific ceremonies or acts. In particular, the President may designate a Vice-President to carry out the duties of the President laid down in Rules 137 and 138(2). Rule 24 Composition of the Bureau 1. The Bureau shall consist of the President and the 14 Vice-Presidents of Parliament. 2. The Quaestors shall be members of the Bureau in an advisory capacity. 3. If voting in the Bureau results in a tie, the President shall have the casting vote. Rule 25 Duties of the Bureau 1. The Bureau shall carry out the duties assigned to it under these Rules of Procedure. 2. The Bureau shall take financial, organisational and administrative decisions on matters concerning the internal organisation of Parliament, its Secretariat and its bodies. 3. The Bureau shall take financial, organisational and administrative decisions on matters concerning Members on a proposal of the Secretary-General or of a political group. 4. The Bureau shall take decisions on matters relating to the conduct of sittings. 5. The Bureau shall adopt the provisions referred to in Rule 36 concerning non-attached Members. 6. The Bureau shall decide the establishment plan of the Parliament's Secretariat and shall lay down regulations concerning the administrative and financial situation of officials and other servants. 7. The Bureau shall draw up Parliament's preliminary draft budget estimates. 8. The Bureau shall adopt the guidelines for the Quaestors, and may request that they carry out certain tasks. 9. The Bureau shall be the authority responsible for authorising meetings or missions of committees away from the usual places of work, hearings as well as study and fact-finding journeys by rapporteurs. Where such meetings or missions are authorised, the language arrangements shall be determined on the basis of the Code of Conduct on multilingualism adopted by the Bureau. The same rule shall apply to delegations. 10. The Bureau shall appoint the Secretary-General in accordance with Rule 234. 11. The Bureau shall lay down the implementing rules relating to the regulations governing political parties and foundations at European level and the rules regarding their funding. 12. The Bureau shall lay down rules concerning the treatment of confidential information by Parliament and its bodies, office-holders and other Members, taking into account any interinstitutional agreement concluded on such matters. Those rules shall be published in the Official Journal of the European Union. 13. The President and/or the Bureau may entrust one or more members of the Bureau with general or specific tasks lying within the competence of the President and/or the Bureau. At the same time the ways and means of carrying them out shall be laid down. 14. The Bureau shall nominate two Vice-Presidents who shall be entrusted with the implementation of relations with the national parliaments. 15. The Bureau shall nominate a Vice-President who shall be entrusted with the implementation of structured consultation with European civil society on major topics. 16. The Bureau shall be responsible for the application of the Statute for Members and shall decide on the amounts of the allowances on the basis of the annual budget. Rule 26 Composition of the Conference of Presidents 1. The Conference of Presidents shall consist of the President of Parliament and the Chairs of the political groups. The Chair of a political group may arrange to be represented by a member of that group. 2. The President of Parliament shall, after giving the opportunity to non-attached Members to express their views, invite one of them to attend meetings of the Conference of Presidents, without the right to vote. 3. The Conference of Presidents shall endeavour to reach a consensus on the matters referred to it. Where a consensus cannot be reached, the matter shall be put to a vote subject to a weighting based on the number of Members in each political group. Rule 27 Duties of the Conference of Presidents 1. The Conference of Presidents shall carry out the duties assigned to it under these Rules of Procedure. 2. The Conference of Presidents shall take decisions on the organisation of Parliament's work and on matters of legislative planning. 3. The Conference of Presidents shall be the authority responsible for matters concerning Parliament's relations with the other institutions and bodies of the European Union and with the national parliaments of Member States. Decisions concerning the mandate and composition of the delegation from Parliament which is to participate in consultations within the Council and in other European Union Institutions on fundamental issues concerning the development of the European Union (Sherpa process) shall be taken on the basis of relevant positions adopted by Parliament and taking into account the diversity of political views represented within Parliament. The Vice-Presidents who have been entrusted with the implementation of Parliament's relations with the national parliaments shall regularly report back to the Conference of Presidents on their activities in that regard. 4. The Conference of Presidents shall be the authority responsible for matters concerning relations with non-member countries and with non-Union institutions and organisations. 5. The Conference of Presidents shall be responsible for organising structured consultation with European civil society on major topics. That consultation may include holding public debates on subjects of general European interest in which interested citizens may participate. The Vice-President responsible for the implementation of such consultation shall report back regularly to the Conference of Presidents on his or her activities in this regard. 6. The Conference of Presidents shall draw up the draft agenda of Parliament's part-sessions. 7. The Conference of Presidents shall make proposals to Parliament concerning the composition and competence of committees, committees of inquiry, joint parliamentary committees and standing delegations. The Conference of Presidents shall be responsible for authorising ad hoc delegations. 8. The Conference of Presidents shall decide pursuant to Rule 37 how seats in the Chamber are to be allocated. 9. The Conference of Presidents shall be the authority responsible for authorising the drawing up of own-initiative reports. 10. The Conference of Presidents shall submit to the Bureau proposals on administrative and budgetary matters concerning the political groups. Rule 28 Duties of the Quaestors The Quaestors shall be responsible for administrative and financial matters directly concerning Members, in accordance with guidelines laid down by the Bureau, as well as for other tasks entrusted to them. Rule 29 Conference of Committee Chairs 1. The Conference of Committee Chairs shall consist of the Chairs of all standing or special committees. It shall elect its chair. 2. In the absence of the Chair, the meeting of the Conference shall be chaired by the oldest Member present. 3. The Conference of Committee Chairs may make recommendations to the Conference of Presidents about the work of committees and the drafting of the agendas of part-sessions. 4. The Bureau and the Conference of Presidents may instruct the Conference of Committee Chairs to carry out specific tasks. Rule 30 Conference of Delegation Chairs 1. The Conference of Delegation Chairs shall consist of the Chairs of all standing interparliamentary delegations. It shall elect its chair. 2. In the absence of the Chair, the meeting of the Conference shall be chaired by the oldest Member present. 3. The Conference of Delegation Chairs may make recommendations to the Conference of Presidents about the work of the delegations. 4. The Bureau and the Conference of Presidents may instruct the Conference of Delegation Chairs to carry out specific tasks. Rule 31 Continuity of an office during the election period When a new Parliament is elected, all bodies and office holders of the outgoing Parliament shall continue to be in office until the first sitting of the new Parliament. Rule 32 Accountability of the Bureau and the Conference of Presidents 1. The minutes of the Bureau and the Conference of Presidents shall be translated into the official languages and distributed to all Members of Parliament. They shall be accessible to the public, unless the Bureau or the Conference of Presidents exceptionally, for reasons of confidentiality, subject to Article 4(1) to (4) of Regulation (EC) No 1049/2001, decides otherwise with regard to certain items of the minutes. 2. Any Member of Parliament may ask questions concerning the performance by the Bureau, the Conference of Presidents and the Quaestors of their respective duties. Such questions shall be submitted to the President in writing, notified to Members and published on Parliament's website within 30 days of tabling, together with the answers given. CHAPTER 4 Political groups Rule 33 Establishment and dissolution of political groups 1. Members may form themselves into groups according to their political affinities. Parliament need not normally evaluate the political affinity of members of a group. In forming a group together under this Rule, the Members concerned accept by definition that they have political affinity. Only when this is denied by the Members concerned is it necessary for Parliament to evaluate whether the group has been constituted in accordance with the Rules. 2. A political group shall consist of Members elected in at least one-quarter of the Member States. The minimum number of Members required to form a political group shall be 25. 3. If a group falls below one of the required thresholds, the President, with the agreement of the Conference of Presidents, may allow it to continue to exist until Parliament's next constitutive sitting, provided the following conditions are met: \u2014 the members continue to represent at least one-fifth of the Member States; \u2014 the group has been in existence for a period that is longer than a year. The President shall not apply this derogation where there is sufficient evidence to suspect that it is being abused. 4. A Member may not belong to more than one political group. 5. The President shall be notified in a statement when a political group is set up. That statement shall specify: \u2014 the name of the group, \u2014 a political declaration, setting out the purpose of the group, and The political declaration of a group shall set out the values that the group stands for and the main political objectives which its members intend to pursue together in the framework of the exercise of their mandate. The declaration shall describe the common political orientation of the group in a substantial, distinctive and genuine way. \u2014 the names of its members and bureau members. All members of the group shall declare in writing in an annex to the statement that they share the same political affinity. 6. The statement shall be annexed to the minutes of the part-session during which the announcement of the establishment of the political group is made. 7. The President shall announce the establishment of political groups in Parliament. Such announcement shall have retroactive legal effect from the moment when the group notified its establishment to the President in accordance with this Rule. The President shall also announce the dissolution of political groups in Parliament. Such an announcement will take legal effect on the day following that on which the political group no longer met the conditions for existence. Rule 34 Activities and legal situation of the political groups 1. The political groups shall carry out their duties as part of the activities of the Union, including the tasks allocated to them by these Rules of Procedure. The political groups shall be provided with a secretariat on the basis of the establishment plan of the Parliament's Secretariat, with administrative facilities and with the appropriations entered for that purpose in Parliament's budget. 2. At the beginning of each parliamentary term, the Conference of Presidents shall endeavour to agree procedures for reflecting the political diversity of Parliament in the committees and delegations, as well as in the decision-making bodies. 3. The Bureau shall, having regard to any proposal made by the Conference of Presidents, lay down the rules relating to the provision, implementation and monitoring of the facilities and appropriations referred to in paragraph 1, as well as to the related delegations of budget implementation powers and the consequences of any failure to respect those rules. 4. Those rules shall determine the administrative and financial consequences in the event of the dissolution of a political group. Rule 35 Intergroups 1. Individual Members may form Intergroups or other unofficial groupings of Members, for the purpose of holding informal exchanges of views on specific issues across different political groups, drawing on members of different parliamentary committees, and of promoting contact between Members and civil society. 2. Intergroups as well as other unofficial groupings shall be fully transparent in their actions and shall not engage in any activities which might result in confusion with the official activities of Parliament or of its bodies. They may not organise events in third countries that coincide with a mission of an official Parliament body, including an official election observation delegation. 3. Provided that the conditions laid down in Parliament's internal rules governing the establishment of such groupings are complied with, a political group may facilitate their activities by providing them with logistical support. 4. Intergroups shall be required to make an annual declaration of any support, whether in cash or in kind (e.g. secretarial assistance), which, if offered to Members as individuals, would have had to be declared under Annex I. Other unofficial groupings shall also be required to declare, by the end of the following month, any support, whether in cash or in kind, which Members have not declared individually in accordance with their obligations under Annex I. 5. Only interest representatives who are registered in the Transparency register may participate in intergroup or other unofficial grouping activities organised on Parliament's premises, for instance by attending meetings or events of the intergroup or other unofficial grouping, by offering support to it, or by co-hosting its events. 6. The Quaestors shall keep a register of the declarations referred to in paragraph 4. The Quaestors shall adopt detailed rules on those declarations and their publication on Parliament's website. 7. The Quaestors shall ensure the effective enforcement of this Rule. Rule 36 Non-attached Members 1. Members who do not belong to a political group shall be provided with a secretariat. The detailed arrangements concerning such provision of secretariats shall be laid down by the Bureau on a proposal from the Secretary-General. 2. The Bureau shall determine the status and parliamentary rights of non-attached Members. 3. The Bureau shall lay down the rules relating to the provision, implementation and auditing of appropriations entered in Parliament's budget to cover the secretarial expenses and administrative facilities for non-attached Members. Rule 37 Allocation of seats in the Chamber The Conference of Presidents shall decide how seats in the Chamber are to be allocated to the political groups, the non-attached Members and the institutions of the Union. TITLE II LEGISLATIVE, BUDGETARY, DISCHARGE AND OTHER PROCEDURES CHAPTER 1 Legislative procedures \u2014 general provisions Rule 38 Annual programming 1. Parliament shall work together with the Commission and the Council to determine the legislative planning of the Union. Parliament and the Commission shall cooperate in preparing the Commission Work Programme \u2014 which is the Commission's contribution to the Union's annual and multiannual programming \u2014 in accordance with the timetable and arrangements agreed between the two institutions (15). 2. After the adoption of the Commission Work Programme, the Parliament, the Council and the Commission will, pursuant to paragraph 7 of the Interinstitutional Agreement on Better Law-Making (16), exchange views and agree on a joint declaration on annual interinstitutional programming that sets out broad objectives and priorities. Before negotiating with the Council and the Commission on the joint declaration, the President shall hold an exchange of views with the Conference of Presidents and the Conference of Committee Chairs regarding Parliament's broad objectives and priorities. Before signing the joint declaration, the President shall seek the approval of the Conference of Presidents. 3. The President shall forward any resolution adopted by Parliament concerning legislative planning and priorities to the other institutions which participate in the Union's legislative procedure and to the parliaments of the Member States. 4. If the Commission intends to withdraw a proposal, the relevant Commissioner shall be invited by the committee responsible to a meeting to discuss that intention. The Presidency of the Council may also be invited to that meeting. If the committee responsible disagrees with the intended withdrawal, it may request that the Commission make a statement to Parliament. Rule 132 shall apply. Rule 39 Respect for fundamental rights 1. In all of its activities, Parliament shall fully respect the rights, freedoms and principles recognised by Article 6 of the Treaty on European Union, and the values enshrined in Article 2 thereof. 2. Where the committee responsible for the subject matter, a political group or Members reaching at least the low threshold are of the opinion that a proposal for a legislative act, in whole or in part, does not comply with the fundamental rights of the European Union, the matter shall, at their request, be referred to the committee responsible for the protection of fundamental rights. 3. That request shall be submitted within four working weeks of the announcement in Parliament of the referral to the committee responsible for the subject matter. 4. The opinion of the committee responsible for the protection of fundamental rights shall be annexed to the report of the committee responsible for the subject-matter. Rule 40 Verification of legal basis 1. When a proposal for a legally binding act is referred to the committee responsible for the subject-matter, that committee shall first verify its legal basis. 2. If that committee disputes the validity or the appropriateness of the legal basis, including in the context of the verification of compliance with Article 5 of the Treaty on European Union, it shall request the opinion of the committee responsible for legal affairs. 3. In addition, the committee responsible for legal affairs may, on its own initiative, take up at any stage of the legislative procedure questions concerning the legal basis. In such cases it shall duly inform the committee responsible for the subject-matter. 4. If, where appropriate after the exchange of views with the Council and the Commission in accordance with the arrangements agreed at interinstitutional level (17), the committee responsible for legal affairs decides to dispute the validity or the appropriateness of the legal basis, it shall report its conclusions to Parliament. Without prejudice to Rule 61, Parliament shall vote on this before voting on the substance of the proposal. 5. If the committee responsible for the subject-matter or the committee responsible for legal affairs have not disputed the validity or appropriateness of the legal basis, amendments tabled in Parliament to change the legal basis shall be inadmissible. Rule 41 Delegation of legislative powers and conferral of implementing powers 1. When scrutinising a proposal for a legislative act which delegates powers to the Commission as provided for in Article 290 of the Treaty on the Functioning of the European Union, Parliament shall pay particular attention to the objectives, content, scope and duration of the delegation, and to the conditions to which it is subject. 2. When scrutinising a proposal for a legislative act which confers implementing powers pursuant to Article 291 of the Treaty on the Functioning of the European Union, Parliament shall pay particular attention to the fact that, in exercising an implementing power, the Commission may neither amend nor supplement the legislative act, even in respect of its non-essential elements. 3. The committee responsible for the subject-matter may at any time request the opinion of the committee that is responsible for the interpretation and application of Union law. 4. In addition, the committee responsible for the interpretation and application of Union law may, on its own initiative, take up questions concerning the delegation of legislative powers and the conferral of implementing powers. In such cases, it shall duly inform the committee responsible for the subject-matter. Rule 42 Verification of financial compatibility 1. Where a proposal for a legally binding act has financial implications, Parliament shall establish whether sufficient financial resources are provided. 2. The committee responsible for the subject-matter shall check that any proposal for a legally binding act is financially compatible with the multiannual financial framework regulation. 3. When the committee responsible for the subject-matter amends the financial endowment of the act it is considering, it shall request the opinion of the committee responsible for budgetary issues. 4. In addition, the committee responsible for budgetary issues may, on its own initiative, take up questions concerning the financial compatibility of proposals for legally binding acts. In such cases, it shall duly inform the committee responsible for the subject-matter. 5. If the committee responsible for budgetary issues decides to dispute the financial compatibility of the proposal, it shall report its conclusions to Parliament before Parliament votes on the proposal. Rule 43 Examination of respect for the principles of subsidiarity and proportionality 1. During the examination of a proposal for a legislative act, Parliament shall pay particular attention to whether that proposal respects the principles of subsidiarity and proportionality. 2. Only the committee responsible for respect for the principle of subsidiarity may make recommendations, for the attention of the committee responsible for the subject-matter, in respect of a proposal for a legislative act. 3. Except in the cases of urgency referred to in Article 4 of Protocol No 1 on the role of national parliaments in the European Union, the committee responsible for the subject-matter shall not proceed to its final vote before the expiry of the deadline of eight weeks laid down in Article 6 of Protocol No 2 on the application of the principles of subsidiarity and proportionality. 4. If a national parliament sends the President a reasoned opinion in accordance with Article 3 of Protocol No 1, that document shall be referred to the committee responsible for the subject-matter and forwarded, for information, to the committee responsible for respect for the principle of subsidiarity. 5. Where reasoned opinions on the non-compliance of a proposal for a legislative act with the principle of subsidiarity represent at least one third of all the votes allocated to the national parliaments in accordance with the second subparagraph of Article 7(1) of Protocol No 2, or a quarter in the case of a proposal for a legislative act submitted on the basis of Article 76 of the Treaty on the Functioning of the European Union, Parliament shall not take a decision until the author of the proposal has stated how it intends to proceed. 6. Where, under the ordinary legislative procedure, reasoned opinions on the non-compliance of a proposal for a legislative act with the principle of subsidiarity represent at least a simple majority of the votes allocated to the national parliaments in accordance with the second subparagraph of Article 7(1) of Protocol No 2, the committee responsible for the subject-matter, having considered the reasoned opinions submitted by the national parliaments and the Commission, and having heard the views of the committee responsible for respect for the principle of subsidiarity, may recommend to Parliament that it reject the proposal on the grounds of infringement of the principle of subsidiarity or submit to Parliament any other recommendation, which may include suggestions for amendments related to respect of the principle of subsidiarity. The opinion given by the committee responsible for respect for the principle of subsidiarity shall be annexed to any such recommendation. The recommendation shall be submitted to Parliament for debate and a vote. If a recommendation to reject the proposal is adopted by a majority of the votes cast, the President shall declare the procedure to be closed. Where Parliament does not reject the proposal, the procedure shall continue, taking into account any recommendations approved by Parliament. Rule 44 Access to documents and provision of information to Parliament 1. Throughout the legislative procedure, Parliament and its committees shall request access to all documents relating to proposals for legislative acts under the same conditions as the Council and its working parties. 2. During the examination of a proposal for a legislative act, the committee responsible shall ask the Commission and the Council to keep it informed of the progress of that proposal in the Council and its working parties, and in particular to inform it of any emerging compromises which would substantially amend the original proposal or of the author's intention to withdraw its proposal. Rule 45 Representation of Parliament in Council meetings When the Council invites Parliament to take part in a Council meeting, the President shall ask the Chair or rapporteur of the committee responsible for the subject matter, or another Member designated by that committee, to represent Parliament. Rule 46 Right of Parliament to submit proposals In cases where the Treaties confer a right of initiative on Parliament, the committee responsible may decide to draw up an own-initiative report in accordance with Rule 54. The report shall include: (a) a motion for a resolution; (b) a draft proposal; (c) an explanatory statement including, where appropriate, a financial statement. Where the adoption of an act by Parliament requires the approval or the consent of the Council and the opinion or the consent of the Commission, Parliament may, following the vote on the proposed act, and on a proposal by the rapporteur, decide to postpone the vote on the motion for a resolution until the Council or the Commission have stated their position. Rule 47 Requests to the Commission for submission of proposals 1. Parliament may request the Commission, pursuant to Article 225 of the Treaty on the Functioning of the European Union, to submit any appropriate proposal to it for the adoption of a new act or the amendment of an existing act. Parliament shall do so by adopting a resolution on the basis of an own-initiative report drawn up by the committee responsible in accordance with Rule 54. The resolution shall be adopted by a majority of the component Members of Parliament in the final vote. Parliament may, at the same time, set a deadline for the submission of such a proposal. 2. Any Member may table a proposal for a Union act on the basis of the right of initiative granted to Parliament pursuant to Article 225 of the Treaty on the Functioning of the European Union. Such a proposal may be tabled jointly by up to 10 Members. The proposal shall indicate the legal basis on which it is made and may be accompanied by an explanatory statement of no more than 150 words. The proposal shall be submitted to the President, who shall verify whether the legal requirements are fulfilled. The President may refer the proposal for an opinion on the appropriateness of the legal basis to the committee responsible for such verification. If the President declares the proposal to be admissible, he or she shall announce it in plenary and refer it to the committee responsible for the subject matter. Before such referral to the committee responsible for the subject matter, the proposal shall be translated into those official languages which the Chair of that committee considers to be necessary in order for summary consideration to be possible. The committee responsible for the subject matter shall take a decision on further action within three months of the referral, after giving the authors of the proposal the opportunity to address the committee. The authors of the proposal shall be named in the title of the report. 3. Parliament's resolution shall indicate the appropriate legal basis and shall be accompanied by recommendations concerning the content of the required proposal. 4. Where a proposal has financial implications, Parliament shall indicate how sufficient financial resources can be provided. 5. The committee responsible for the subject matter shall monitor the progress of preparation of any proposed Union legal act drawn up following a particular request by Parliament. 6. The Conference of Committee Chairs shall regularly monitor whether the Commission is complying with paragraph 10 of the Interinstitutional Agreement on Better Law-Making, according to which the Commission is to reply to requests for the submission of proposals within three months by adopting a specific communication stating the intended follow-up actions to be taken. The Conference of Committee Chairs shall regularly report on the results of such monitoring to the Conference of Presidents. Rule 48 Consideration of legally binding acts 1. The President shall refer proposals for legally binding acts received from other institutions or Member States to the committee responsible, for consideration. 2. In cases of doubt, the President may, before the announcement in Parliament of a referral to the committee responsible, submit a question concerning competence to the Conference of Presidents. The Conference of Presidents shall adopt its decision on the basis of a recommendation from the Conference of Committee Chairs, or the chair of the Conference of Committee Chairs, in accordance with Rule 211(2). 3. The committee responsible may, at any time, decide to appoint a rapporteur to follow the preparatory phase of a proposal. It shall give particular consideration to doing so where the proposal is listed in the Commission Work Programme. 4. In the event of a conflict between a provision of the Rules of Procedure relating to the second and third readings and any other provision of the Rules, the provision relating to the second and third readings shall take precedence. Rule 49 Acceleration of legislative procedures The acceleration of legislative procedures in coordination with the Council and Commission regarding specific proposals, selected in particular from among those identified as priorities in the joint declaration on annual interinstitutional programming pursuant to Rule 38(2), may be agreed by the committee or committees responsible. Rule 50 Legislative procedures on initiatives originating from institutions other than the Commission or from Member States 1. When dealing with initiatives originating from institutions other than the Commission or originating from Member States, the committee responsible may invite representatives of the institutions or those originating Member States to present their initiative to the committee. The representatives of the originating Member States may be accompanied by the Presidency of the Council. 2. Before the committee responsible proceeds to the vote, it shall ask the Commission whether it is preparing an opinion on the initiative, or if it intends to submit an alternative proposal within a short period of time. If the answer that it receives is in the affirmative, the committee shall not adopt its report before receiving that opinion or alternative proposal. 3. When two or more proposals originating from the Commission and/or another institution and/or the Member States with the same legislative objective have been submitted to Parliament simultaneously or within a short period of time, Parliament shall deal with them in a single report. In its report, the committee responsible shall indicate to which text it has proposed amendments and it shall refer to all other texts in the legislative resolution. CHAPTER 2 Procedure in committee Rule 51 Legislative reports 1. The Chair of the committee to which a proposal for a legally binding act is referred shall propose to the committee the procedure to be followed. 2. After taking a decision on the procedure to be followed, and if the simplified procedure under Rule 52 does not apply, the committee shall appoint a rapporteur on the proposal for a legally binding act from among its members or permanent substitutes if it has not yet done so on the basis of Rule 48(3). 3. The committee's report shall include: (a) amendments, if any, to the proposal, accompanied, if appropriate, by short justifications, which shall be the responsibility of the author and which shall not be put to the vote; (b) a draft legislative resolution, in accordance with Rule 59(5); (c) if appropriate, an explanatory statement including, where necessary, a financial statement which establishes the magnitude of the financial impact of the report, if any, and its compatibility with the multiannual financial framework; (d) if available, a reference to the Impact Assessment by Parliament. Rule 52 Simplified procedure 1. Following a first discussion of a proposal for a legally binding act, the Chair may propose that it be approved without amendment. Unless members or a political group or groups reaching at least the medium threshold in the committee object, the proposed procedure shall be deemed to have been approved. The Chair, or, if one has been appointed, the rapporteur, shall present to Parliament a report approving the proposal. The second subparagraph of Rule 159(1) and Rule 159(2) and (4) shall apply. 2. Alternatively, the Chair may propose that a set of amendments be drafted by the Chair or by the rapporteur reflecting the committee's discussion. Unless members or a political group or groups reaching at least the medium threshold in the committee object, the proposed procedure shall be deemed to have been approved and the amendments shall be sent to the members of the committee. Unless members or a political group or groups reaching at least the medium threshold in the committee object to the amendments within a set time limit, which shall not be less than 10 working days from the date of dispatch, the report shall be deemed to have been adopted by the committee. In this case, the draft legislative resolution and the amendments shall be submitted to Parliament without debate pursuant to the second subparagraph of Rule 159(1) and Rule 159(2) and (4). If members or a political group or groups reaching at least the medium threshold in the committee object to the amendments, they shall be put to the vote at the next meeting of the committee. 3. With the exception of the provisions concerning the submission to Parliament, this Rule shall apply mutatis mutandis to committee opinions within the meaning of Rule 56. Rule 53 Non-legislative reports 1. Where a committee draws up a non-legislative report, it shall appoint a rapporteur from among its members or permanent substitutes. 2. The committee's report shall include: (a) a motion for a resolution; (b) an explanatory statement including, where necessary, a financial statement which establishes the magnitude of the financial impact of the report, if any, and its compatibility with the multiannual financial framework; (c) the texts of any motions for resolutions to be included under Rule 143(7). Rule 54 Own-initiative reports 1. A committee intending to draw up a non-legislative report or a report under Rule 46 or 47 on a subject within its competence on which no referral has taken place, may do so only with the authorisation of the Conference of Presidents. The Conference of Presidents shall take a decision on requests for authorisation to draw up reports submitted pursuant to the first subparagraph on the basis of implementing provisions, which it shall lay down. 2. Where the Conference of Presidents decides to withhold such authorisation, it shall state its reasons for doing so. Where the subject matter of the report falls within Parliament's right of initiative referred to in Rule 46, the Conference of Presidents may only decide to withhold such authorisation if the conditions set out in the Treaties are not met. 3. In the cases referred to in Rules 46 and 47, the Conference of Presidents shall take a decision within two months. 4. Motions for resolutions submitted to Parliament shall be examined under the short presentation procedure set out in Rule 160. Amendments to such motions for resolutions and requests for split votes or separate votes shall only be admissible for consideration in plenary if they are tabled either by the rapporteur, in order to take account of new information, or by at least one-tenth of the Members. Political groups may table alternative motions for resolutions in accordance with Rule 181(3). Rule 190 shall apply to the committee's motion for a resolution and amendments thereto. Rule 190 shall also apply to the single vote on alternative motions for resolutions. 5. Paragraph 4 shall not apply where the subject of the report qualifies for a key debate in plenary, where the report is drawn up pursuant to the right of initiative referred to in Rule 46 or 47, or where the report has been authorised as a strategic report (18). Rule 55 Drafting of reports 1. The rapporteur shall be responsible for preparing the committee's report and for presenting it to Parliament on behalf of that committee. 2. The explanatory statement shall be the responsibility of the rapporteur and shall not be put to the vote. It must, however, accord with the text of the motion for a resolution as adopted and any amendments proposed by the committee. If it fails to do so, the Chair of the committee may delete the explanatory statement. 3. The report shall state the result of the vote taken on the report as a whole and shall indicate, in line with Rule 218(3), how each member voted. 4. Minority positions may be expressed when the vote on the text as a whole is taken and may, at the request of their authors, be the subject of a written declaration not exceeding 200 words in length, which shall be annexed to the explanatory statement. The Chair shall settle any disputes which may arise as a result of the application of this paragraph. 5. On a proposal from its Chair, the committee may set a deadline within which the rapporteur must submit the draft report. This deadline may be extended or a new rapporteur appointed. 6. Once the deadline has expired, the committee may instruct its Chair to ask for the matter that has been referred to it to be placed on the agenda of one of the next sittings of Parliament. The debates and votes may then be conducted on the basis of an oral report by the committee concerned. Rule 56 Opinions of committees 1. If the committee to which a matter was first referred wishes to hear the views of another committee, or if another committee wishes to make known its views to the committee to which a matter was first referred, such committees may ask the President in accordance with Rule 210(2) for one committee to be named as the committee responsible and the other as the opinion-giving committee. The opinion giving committee may appoint a rapporteur for opinion from among its members or permanent substitutes or send its views in the form of a letter from the Chair. 2. Where the opinion concerns a proposal for a legally binding act, it shall consist of amendments to the text referred to the committee, accompanied, where appropriate, by short justifications. Such justifications shall be the responsibility of their author and shall not be put to the vote. If necessary, the opinion-giving committee may submit a short written justification for the opinion as a whole. That short written justification shall be the responsibility of the rapporteur for the opinion. Where the opinion does not concern a proposal for a legally binding act, it shall consist of suggestions for parts of the motion for a resolution submitted by the committee responsible. The committee responsible shall put these amendments or suggestions to the vote. The opinions shall deal solely with those matters that fall within the areas of responsibility of the opinion-giving committee. 3. The committee responsible shall set a deadline within which the opinion-giving committee must deliver its opinion if it is to be taken into account by the committee responsible. Any changes to the announced timetable shall be immediately communicated by the committee responsible to the opinion-giving committee or opinion giving committees. The committee responsible shall not reach its final conclusions before that time-limit has expired. 4. Alternatively, the opinion-giving committee may decide to present its position in the form of amendments to be tabled directly in the committee responsible following their adoption. These amendments shall be tabled by the Chair or the rapporteur on behalf of the opinion-giving committee. 5. The opinion-giving committee shall table the amendments referred to in paragraph 4 within the deadline for amendments set by the committee responsible. 6. All opinions and amendments adopted by the opinion-giving committee shall be annexed to the report of the committee responsible. 7. Opinion-giving committees within the meaning of this Rule cannot table amendments for consideration by Parliament. 8. The Chair and rapporteur of the opinion-giving committee shall be invited to take part in an advisory capacity in meetings of the committee responsible, insofar as these relate to the matter of common concern. Rule 57 Associated committee procedure 1. Where a question of competence is referred to the Conference of Presidents pursuant to Rule 211, and the Conference of Presidents, on the basis of Annex VI, considers that the matter falls almost equally within the competence of two or more committees, or that different parts of the matter fall within the competence of two or more committees, Rule 56 shall apply with the following additional provisions: \u2014 the timetable shall be jointly agreed by the committees concerned, \u2014 the rapporteurs concerned shall keep each other informed and shall endeavour to agree on the texts they propose to their committees and on their position regarding amendments, \u2014 the Chairs and rapporteurs concerned are bound by the principle of good and sincere cooperation; they shall jointly identify areas of the text falling within their exclusive or shared competence and agree on the precise arrangements for their cooperation; in the event of disagreement about the delimitation of competences the matter shall be submitted, at the request of one of the committees involved, to the Conference of Presidents; the Conference of Presidents may decide on the question of the respective competences or decide that the joint committee procedure under Rule 58 is to apply; it shall take its decision in accordance with the procedure and within the deadline set out in Rule 211, \u2014 the committee responsible shall accept without a vote amendments from an associated committee where they concern matters which fall within the exclusive competence of that associated committee; if the committee responsible fails to respect the exclusive competence of the associated committee, that associated committee may table amendments directly in plenary; if amendments on matters which fall within the shared competence of the committee responsible and an associated committee are not adopted by the committee responsible, the associated committee may table those amendments directly in plenary, \u2014 in the event of a conciliation procedure in respect of the proposal, Parliament's delegation shall include the rapporteur of any associated committee. A decision by the Conference of Presidents to apply the associated committee procedure applies at all stages of the procedure in question. The rights attaching to the status of \u2018committee responsible\u2019 are exercised by the lead committee. In exercising those rights, the lead committee must take due account of the prerogatives of the associated committee. In particular, the lead committee must comply with the obligation to observe the principle of sincere cooperation as regards the timetable and respect the right of the associated committee to determine the amendments submitted in plenary which fall within its exclusive competence. 2. The procedure laid down in this Rule shall not apply to the recommendations to be adopted by the committee responsible under Rule 105. Rule 58 Joint committee procedure 1. When a question of competence is referred to it pursuant to Rule 211, the Conference of Presidents may decide that the procedure with joint meetings of committees and a joint vote is to be applied, provided that: \u2014 by virtue of Annex VI, the matter falls indissociably within the competences of several committees, and \u2014 it is satisfied that the question is of major importance. 2. In that event, the respective rapporteurs shall draw up a single draft report, which shall be examined and voted on by the committees involved, under the joint chairmanship of the committee Chairs. At all stages of the procedure, the rights attaching to the status of committee responsible may be exercised by the committees involved only when they are acting jointly. The committees involved may set up working groups to prepare the meetings and votes. 3. At the second-reading stage of the ordinary legislative procedure, the Council position shall be considered at a joint meeting of the committees involved, which, should no agreement be reached between their Chairs, shall be held on the Wednesday of the first week set aside for meetings of parliamentary bodies following the communication of the Council's position to Parliament. If no agreement is reached on the convening of a further meeting, any such meeting shall be convened by the Chair of the Conference of Committee Chairs. The vote on the recommendation for second reading shall be taken at a joint meeting on the basis of a joint text drafted by the respective rapporteurs of the committees involved or, in the absence of a joint text, on the basis of the amendments tabled in the committees involved. At the third-reading stage of the ordinary legislative procedure, the Chairs and rapporteurs of the committees involved shall be members ex officio of the delegation to the Conciliation Committee. CHAPTER 3 Ordinary legislative procedure SECTION 1 \u2014 FIRST READING Rule 59 Vote in Parliament \u2014 first reading 1. Parliament may approve, amend or reject the draft legislative act. 2. Parliament shall first vote on any proposal for the immediate rejection of the draft legislative act that has been tabled in writing by the committee responsible, a political group or Members reaching at least the low threshold. If that proposal for rejection is adopted, the President shall ask the originating institution to withdraw the draft legislative act. If the originating institution does so, the President shall declare the procedure closed. If the originating institution does not withdraw the draft legislative act, the President shall announce that the first reading of Parliament is concluded, unless, on a proposal of the Chair or rapporteur of the committee responsible or of a political group or Members reaching at least the low threshold, Parliament decides to refer the matter back to the committee responsible for reconsideration. If that proposal for rejection is not adopted, Parliament shall then proceed in accordance with paragraphs 3, 4 and 5. 3. Any provisional agreement tabled by the committee responsible under Rule 74(4) shall be given priority in voting and shall be put to a single vote, unless, at the request of a political group or Members reaching at least the low threshold, Parliament decides instead to proceed with the vote on amendments in accordance with paragraph 4. In that case, Parliament shall also decide whether to hold the vote on the amendments immediately. If not, Parliament shall set a new deadline for amendments and the vote shall take place at a subsequent sitting. If, in that single vote, the provisional agreement is adopted, the President shall announce that the first reading of Parliament has been concluded. If, in that single vote, the provisional agreement fails to secure the majority of the votes cast, the President shall set a new deadline for amendments to the draft legislative act. Such amendments shall then be put to the vote at a subsequent sitting in order for Parliament to conclude its first reading. 4. Save where a proposal for rejection has been adopted in accordance with paragraph 2 or a provisional agreement has been adopted in accordance with paragraph 3, any amendments to the draft legislative act shall then be put to the vote, including, where applicable, individual parts of the provisional agreement where requests have been made for split or separate votes, or competing amendments have been tabled. Before Parliament votes on the amendments, the President may ask the Commission to state its position and the Council to comment. After it has voted on those amendments, Parliament shall vote on the whole draft legislative act, amended or otherwise. If the whole draft legislative act, amended or otherwise, is adopted, the President shall announce that the first reading has been concluded, unless, on a proposal of the Chair or the rapporteur of the committee responsible or of a political group or Members reaching at least the low threshold, Parliament decides to refer the matter back to the committee responsible, for interinstitutional negotiations in accordance with Rules 60 and 74. If the whole draft legislative act, as amended or otherwise, fails to secure a majority of the votes cast, the President shall announce that the first reading has been concluded, unless, on a proposal of the Chair or rapporteur of the committee responsible or of a political group or Members reaching at least the low threshold, Parliament decides to refer the matter back to the committee responsible for reconsideration. 5. After the votes taken under paragraphs 2, 3 and 4, and the votes subsequently taken on amendments to the draft legislative resolution relating to procedural requests, if any, the legislative resolution shall be deemed to have been adopted. If necessary, the legislative resolution shall be modified pursuant to Rule 203(2), in order to reflect the outcome of the votes taken under paragraphs 2, 3 and 4. The text of the legislative resolution and of Parliament's position shall be forwarded, by the President, to the Council and the Commission, as well as, where the draft legislative act originates from them, to the originating group of Member States, the Court of Justice or the European Central Bank. Rule 60 Referral back to the committee responsible If, in accordance with Rule 59, a matter is referred back to the committee responsible for reconsideration or for interinstitutional negotiations in accordance with Rule 74, the committee responsible shall, orally or in writing, report to Parliament within four months. That period may be extended by the Conference of Presidents. Following a referral back to committee, the lead committee must, before taking a decision on the procedure to be followed, allow an associated committee, as Rule 57 provides, to make choices as to the amendments which fall within its exclusive competence, and in particular to choose which amendments are to be resubmitted in plenary. Nothing prevents Parliament from deciding to hold, if appropriate, a concluding debate following the report by the committee responsible, to which the matter was referred back. Rule 61 Renewed referral to Parliament 1. The President shall, at the request of the committee responsible, ask the Commission to refer its proposal again to Parliament where: \u2014 the Commission replaces, substantially amends or intends to substantially amend its initial proposal after Parliament has adopted its position, except where this is done in order to take account of Parliament's position, \u2014 the nature of the problem with which the proposal is concerned substantially changes as a result of the passage of time or changes in circumstances, or \u2014 new elections to Parliament have taken place since it adopted its position, and the Conference of Presidents considers it desirable. 2. If a modification of the legal basis of a proposal is envisaged which would result in the ordinary legislative procedure no longer applying to that proposal, the Parliament, Council and Commission will, pursuant to paragraph 25 of the Interinstitutional Agreement on Better Law Making, acting through their respective Presidents or their representatives, exchange views thereon. 3. Following the exchange of views referred to in paragraph 2, the President shall, at the request of the committee responsible, ask the Council to refer the draft legally binding act to Parliament again, where the Commission or the Council intends to modify the legal basis provided for in Parliament's position at first reading, with the result that the ordinary legislative procedure would no longer apply. Rule 62 First-reading agreement Where, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, the Council has informed Parliament that it has approved Parliament's position, the President, following finalisation in accordance with Rule 203, shall announce in Parliament that the legislative act has been adopted in the wording which corresponds to the position of Parliament. SECTION 2 \u2014 SECOND READING Rule 63 Communication of the Council's position 1. Communication of the Council's position pursuant to Article 294 of the Treaty on the Functioning of the European Union takes place when it is announced by the President in Parliament. The President shall make the announcement after receiving the documents which contain the position itself, all declarations made in the Council minutes when it adopted the position, the reasons which led the Council to adopt its position, and the Commission's position, duly translated into the official languages of the European Union. The President's announcement shall be made during the part-session following the receipt of those documents. Before making the announcement, the President establishes, after consulting the Chair of the committee responsible, or the rapporteur, or both of them, that the text received is indeed Council's first reading position and that the circumstances described in Rule 61 do not apply. Failing this, the President, together with the committee responsible and, where possible, in agreement with the Council, seeks an appropriate solution. 2. On the day of its announcement in Parliament, the Council's position shall be deemed to have been referred automatically to the committee responsible at first reading. 3. A list of such communications shall be published in the minutes of the sitting together with the names of the committees responsible. Rule 64 Extension of time limits 1. The President shall, at the request of the Chair of the committee responsible, extend the time-limits for second reading in accordance with Article 294(14) of the Treaty on the Functioning of the European Union. 2. The President shall notify Parliament of any extension of time limits under Article 294(14) of the Treaty on the Functioning of the European Union, whether such extensions occur at the initiative of Parliament or of the Council. Rule 65 Procedure in the committee responsible 1. The Council's position shall be entered as a priority item on the agenda of the first meeting of the committee responsible to take place after its communication. The Council may be invited to present its position. 2. Unless the committee responsible decides otherwise, the rapporteur at second reading shall be the same as the rapporteur at first reading. 3. The provisions of Rule 68(2) and (3) that concern the admissibility of the amendments to the Council's position shall apply to the proceedings in the committee responsible; only members or permanent substitutes of that committee may table proposals for rejection and amendments. The committee shall decide by a majority of the votes cast. 4. The committee responsible shall submit a recommendation for second reading, proposing the approval, amendment or rejection of the position adopted by the Council. The recommendation shall include a short justification for the decision proposed. 5. Rules 51, 52, 56 and 198 shall not apply during second reading. Rule 66 Submission to Parliament The Council's position and, where available, the committee responsible's recommendation for second reading shall be automatically placed on the draft agenda for the part-session the Wednesday of which falls before and closest to the day that the three month period or, if extended in accordance with Rule 64, the four month period, expires, unless the matter has been dealt with at an earlier part-session. Rule 67 Vote in Parliament \u2014 second reading 1. Parliament shall first vote on any proposal for the immediate rejection of Council's position that has been tabled in writing by the committee responsible, a political group or Members reaching at least the low threshold. For it to be adopted, such a proposal for rejection shall require the votes of a majority of the component Members of Parliament. If that proposal for rejection is adopted, the Council's position is rejected and the President shall announce in Parliament that the legislative procedure is closed. If that proposal for rejection is not adopted, Parliament shall then proceed in accordance with paragraphs 2 to 5. 2. Any provisional agreement tabled under Rule 74(4) by the committee responsible shall be given priority in voting and put to a single vote, unless, at the request of a political group or Members reaching at least the low threshold, Parliament decides to proceed immediately with the vote on amendments in accordance with paragraph 3. If, in a single vote, the provisional agreement secures the votes of a majority of the component Members of Parliament, the President shall announce in Parliament that the second reading of Parliament has been concluded. If, in a single vote, the provisional agreement fails to secure the majority of the component Members of Parliament, Parliament shall then proceed in accordance with paragraphs 3, 4 and 5. 3. Except where a proposal for rejection has been adopted in accordance with paragraph 1 or a provisional agreement has been adopted in accordance with paragraph 2, any amendments to the Council's position, including those contained in the provisional agreement tabled in accordance with Rule 74(4) by the committee responsible, shall then be put to the vote. Any amendment to the Council's position shall be adopted only if it secures the votes of a majority of the component Members of Parliament. Before voting on the amendments, the President may ask the Commission to state its position and the Council to comment. 4. Notwithstanding a vote by Parliament against the initial proposal to reject the Council's position under paragraph 1, Parliament may, on the proposal of the Chair or the rapporteur of the committee responsible or of a political group or Members reaching at least the low threshold, consider a further proposal for rejection after voting on the amendments under paragraphs 2 or 3. For it to be adopted, such a proposal shall require the votes of a majority of the component Members of Parliament. If the Council's position is rejected, the President shall announce in Parliament that the legislative procedure is closed. 5. After the votes taken under paragraphs 1 to 4 and the votes subsequently taken on amendments to the draft legislative resolution relating to procedural requests, the President shall announce that the second reading of Parliament has been concluded and the legislative resolution shall be deemed to have been adopted. If necessary, the legislative resolution shall be modified, pursuant to Rule 203(2), in order to reflect the outcome of the votes taken under paragraphs 1 to 4 or the application of Rule 69. The text of the legislative resolution and of Parliament's position, if any, shall be forwarded by the President to the Council and to the Commission. Where no proposal to reject or amend the Council's position has been tabled, it shall be deemed to have been approved. Rule 68 Admissibility of amendments to the Council's position 1. The committee responsible, a political group or Members reaching at least the low threshold may table amendments to the Council's position for consideration in Parliament. 2. An amendment to the Council's position shall be admissible only if it complies with Rules 180 and 181 and seeks: (a) to restore wholly or partly the position adopted by Parliament at its first reading; or (b) to reach a compromise between the Council and Parliament; or (c) to amend a part of the text of a Council position which was not included in \u2014 or differs in content from \u2014 the proposal submitted at first reading; or (d) to take account of a new fact or legal situation which has arisen since the adoption of Parliament's position at first reading. The President's discretion to declare an amendment admissible or inadmissible may not be questioned. 3. If new elections have taken place since the first reading, but Rule 61 has not been invoked, the President may decide to waive the restrictions on admissibility laid down in paragraph 2. Rule 69 Second-reading agreement Where no proposal to reject the Council's position and no amendments to that position have been tabled under Rules 67 and 68 within the time limits set for tabling and voting on amendments or on proposals to reject, the President shall announce in Parliament that the proposed act has been adopted. SECTION 3 \u2014 INTERINSTITUTIONAL NEGOTIATIONS DURING THE ORDINARY LEGISLATIVE PROCEDURE Rule 70 General provisions Negotiations with the other institutions aimed at reaching an agreement in the course of a legislative procedure may only be entered into following a decision taken in accordance with Rule 71, Rule 72 or Rule 73 or following a referral back by Parliament for interinstitutional negotiations. Such negotiations shall be conducted having regard to the Code of Conduct laid down by the Conference of Presidents (19). Rule 71 Negotiations ahead of Parliament's first reading 1. Where a committee has adopted a legislative report pursuant to Rule 51, it may decide, by a majority of its members, to enter into negotiations on the basis of that report. 2. Decisions to enter into negotiations shall be announced at the beginning of the part-session following their adoption in committee. By the end of the day following the announcement in Parliament, Members or a political group or groups reaching at least the medium threshold may request in writing that a committee decision to enter into negotiations be put to the vote. Parliament shall then proceed to that vote during the same part-session. If no such request is received by the expiry of the deadline laid down in the first subparagraph, the President shall inform Parliament that this is the case. If a request is made, the President may, immediately prior to the vote, give the floor to one speaker in favour of the committee's decision to enter into negotiations and to one speaker against that decision. Each speaker may make a statement lasting no more than two minutes. 3. If Parliament rejects the committee's decision to enter into negotiations, the draft legislative act and the report of the committee responsible shall be placed on the agenda of the following part-session, and the President shall set a deadline for amendments. Rule 59(4) shall apply. 4. Negotiations may start at any time after the deadline laid down in the first subparagraph of paragraph 2 has expired without a request for a vote in Parliament on the decision to enter into negotiations having been made. If such a request has been made, negotiations may start at any time after the committee decision to enter into negotiations has been approved in Parliament. Rule 72 Negotiations ahead of Council's first reading Where Parliament has adopted its position at first reading, that position shall constitute the mandate for any negotiations with other institutions. The committee responsible may decide, by a majority of its members, to enter into negotiations at any time thereafter. Such decisions shall be announced in Parliament during the part-session following the vote in committee and a reference to them shall be included in the minutes. Rule 73 Negotiations ahead of Parliament's second reading Where the Council position at first reading has been referred to the committee responsible, Parliament's position at first reading shall, subject to Rule 68, constitute the mandate for any negotiations with other institutions. The committee responsible may decide to enter into negotiations at any time thereafter. Where the Council position at first reading contains elements not covered by the draft legislative act or by Parliament's position at first reading, the committee may adopt guidelines, including in the form of amendments to the Council position, for the negotiating team. Rule 74 Conduct of negotiations 1. Parliament's negotiating team shall be led by the rapporteur and shall be presided over by the Chair of the committee responsible or by a Vice-Chair designated by the Chair. It shall at least consist of the shadow rapporteurs from each political group that wishes to participate. 2. Any document intended to be discussed at a meeting with the Council and the Commission (\u2018trilogue\u2019) shall be circulated to the negotiating team at least 48 hours or, in cases of urgency, at least 24 hours in advance of that trilogue. 3. After each trilogue, the Chair of the negotiating team and the rapporteur shall, on behalf of the negotiating team, report back to the next meeting of the committee responsible. Where it is not feasible to convene a meeting of the committee in a timely manner, the Chair of the negotiating team and the rapporteur shall, on behalf of the negotiating team, report back to a meeting of the committee coordinators. 4. If negotiations lead to a provisional agreement, the committee responsible shall be informed without delay. Documents reflecting the outcome of the concluding trilogue shall be made available to the committee responsible and shall be published. The provisional agreement shall be submitted to the committee responsible, which shall decide, by way of a single vote by a majority of the votes cast, whether to approve it. If approved, it shall be tabled for consideration by Parliament, in a presentation which clearly indicates the modifications to the draft legislative act. 5. In the event of a disagreement between the committees concerned under Rules 57 and 58, the detailed rules for the opening of negotiations and the conduct of such negotiations shall be determined by the Chair of the Conference of Committee Chairs in accordance with the principles set out in those Rules. SECTION 4 \u2014 CONCILIATION AND THIRD READING Rule 75 Extension of time limits 1. The President shall, at the request of Parliament's delegation to the conciliation committee, extend the time limits for third reading in accordance with Article 294(14) of the Treaty on the Functioning of the European Union. 2. The President shall notify Parliament of any extension of time limits under Article 294(14) of the Treaty on the Functioning of the European Union, whether such extensions occur on the initiative of Parliament or of the Council. Rule 76 Convening of the Conciliation Committee Where the Council informs Parliament that it is unable to approve all of Parliament's amendments to the Council's position, the President shall, together with the Council, agree on a time and place for a first meeting of the Conciliation Committee. The six-week, or, if extended, eight-week, deadline provided for in Article 294(10) of the Treaty on the Functioning of the European Union shall run from the day on which the Committee first meets. Rule 77 Delegation to the Conciliation Committee 1. Parliament's delegation to the Conciliation Committee shall consist of a number of members equal to the number of members of the Council delegation. 2. The political composition of the delegation shall correspond to the composition of Parliament by political groups. The Conference of Presidents shall determine the exact number of Members from each political group that are to serve as members of Parliament's delegation. 3. The members of the delegation shall be appointed by the political groups for each conciliation case, preferably from among the members of the committee responsible, except for three members who shall be appointed as permanent members of successive delegations for a period of 12 months. The three permanent members shall be appointed by the political groups from among the Vice-Presidents and shall represent at least two different political groups. The Chair and the rapporteur in second reading of the committee responsible as well as the rapporteur of any associated committee shall in each case be members of the delegation. 4. The political groups represented on the delegation shall appoint substitutes. 5. Political groups not represented on the delegation may each send one representative to any internal preparatory meeting of the delegation. If the delegation does not include any non-attached Members, one non-attached Member may attend any internal preparatory meetings of the delegation. 6. The delegation shall be led by the President or by one of the three permanent members. 7. The delegation shall decide by a majority of its members. Its deliberations shall not be public. The Conference of Presidents shall lay down further procedural guidelines for the work of the delegation to the Conciliation Committee. 8. The delegation shall report back the results of the conciliation to Parliament. Rule 78 Joint text 1. Where agreement on a joint text is reached within the Conciliation Committee, the matter shall be placed on the agenda of a sitting of Parliament to be held within six or, if extended, eight weeks of the date of approval of the joint text by the Conciliation Committee. 2. The Chair or another designated member of Parliament's delegation to the Conciliation Committee shall make a statement on the joint text, which shall be accompanied by a report. 3. No amendments may be tabled to the joint text. 4. The joint text as a whole shall be the subject of a single vote. The joint text shall be approved if it secures a majority of the votes cast. 5. If no agreement is reached on a joint text within the Conciliation Committee, the Chair or another designated member of Parliament's delegation to the Conciliation Committee shall make a statement. That statement shall be followed by a debate. 6. During the conciliation procedure between Parliament and the Council following the second reading, no referral back to committee shall take place. 7. Rules 51, 52 and 56 shall not apply during third reading. SECTION 5 \u2014 CONCLUSION OF THE PROCEDURE Rule 79 Signing and publication of adopted acts After finalisation of the text adopted in accordance with Rule 203 and Annex VIII and once it has been verified that all the procedures have been duly completed, acts adopted in accordance with the ordinary legislative procedure shall be signed by the President and the Secretary-General. After signature of the act, the Secretaries-General of Parliament and of the Council shall arrange for its publication in the Official Journal of the European Union. CHAPTER 4 Provisions specific to the consultation procedure Rule 80 Modified proposal for a legally binding act If the Commission intends to replace or modify its proposal for a legally binding act, the committee responsible may postpone its examination of the matter until it has received the new proposal or the amendments of the Commission. Rule 81 Commission position on amendments Before the committee responsible proceeds to the final vote on a proposal for a legally binding act, it may ask the Commission to state its position on all the amendments to the proposal that the committee has adopted. If appropriate, that position shall be included in the report. Rule 82 Vote in Parliament Rule 59(1), (2), (4) and (5) shall apply mutatis mutandis. Rule 83 Follow-up to Parliament's position 1. In the period following the adoption by Parliament of its position on a draft legally binding act, the Chair and the rapporteur of the committee responsible shall monitor the progress of that draft act over the course of the procedure leading to its adoption by the Council, in particular in order to ensure that any undertakings given by the Council or the Commission to Parliament concerning its position are properly observed. The Chair and the rapporteur of the committee responsible shall report back to the committee regularly. 2. The committee responsible may invite the Commission and the Council to discuss the matter with it. 3. At any stage of the follow-up procedure, the committee responsible may, if it deems it to be necessary, table a motion for a resolution recommending that Parliament: \u2014 call upon the Commission to withdraw its proposal, \u2014 call upon the Commission or the Council to refer the matter to Parliament once again, pursuant to Rule 84, or call upon the Commission to present a new proposal, or \u2014 decide to take any other action that it deems to be appropriate. Such motion shall be placed on the draft agenda of the part-session following the adoption of the motion by the committee. Rule 84 Renewed referral to Parliament 1. At the request of the committee responsible, the President shall call on the Council to reconsult Parliament in the same circumstances and under the same conditions as those set out in Rule 61(1). At the request of the committee responsible, the President shall also call on the Council to reconsult Parliament where the Council substantially amends or intends to substantially amend the draft legally binding act on which Parliament originally delivered its position, except where this is done in order to incorporate Parliament's amendments. 2. The President shall also request that a draft legally binding act be referred again to Parliament in the circumstances defined in this Rule where, on a proposal from a political group or Members reaching at least the low threshold, Parliament so decides. CHAPTER 5 Constitutional matters Rule 85 Ordinary Treaty revision 1. In accordance with Rules 46 and 54, the committee responsible may submit to Parliament a report containing proposals, addressed to the Council, for the amendment of the Treaties. 2. Where Parliament is consulted, in accordance with Article 48(3) of the Treaty on European Union, on a proposal for a decision of the European Council in favour of examining amendments to the Treaties, the matter shall be referred to the committee responsible. The committee shall draw up a report comprising: \u2014 a motion for a resolution which states whether Parliament approves or rejects the proposed decision and which may contain proposals for the attention of the Convention or of the conference of representatives of the governments of the Member States, \u2014 if appropriate, an explanatory statement. 3. If the European Council decides to convene a Convention, Parliament shall, on a proposal by the Conference of Presidents, appoint Parliament's representatives to that Convention. Parliament's delegation shall elect its leader and its candidates for membership of any steering group or bureau set up by the Convention. 4. Where the European Council requests Parliament's consent to a decision not to convene a Convention for the examination of proposed amendments of the Treaties, this request shall be referred to the committee responsible in accordance with Rule 105. Rule 86 Simplified Treaty revision 1. In accordance with Rules 46 and 54, the committee responsible may submit to Parliament, in accordance with the procedure laid down in Article 48(6) of the Treaty on European Union, a report containing proposals, addressed to the European Council, for the revision of all or part of the provisions of Part Three of the Treaty on the Functioning of the European Union. 2. Where Parliament is consulted, in accordance with Article 48(6) of the Treaty on European Union, on a proposal for a decision of the European Council amending Part Three of the Treaty on the Functioning of the European Union, Rule 85(2) shall apply mutatis mutandis. In that event, the motion for a resolution may contain proposals for amendments only of provisions of Part Three of the Treaty on the Functioning of the European Union. Rule 87 Accession treaties 1. Any application by a European State to become a member of the European Union, in accordance with Article 49 of the Treaty on European Union, shall be referred for consideration to the committee responsible. 2. Parliament may, on a proposal from the committee responsible, a political group or Members reaching at least the low threshold, decide to request the Commission and the Council to take part in a debate before any accession negotiations with the applicant State commence. 3. The committee responsible shall request the Commission and the Council to provide it with full and regular information about the progress of the accession negotiations, if necessary on a confidential basis. 4. At any stage of the accession negotiations, Parliament may, on the basis of a report from the committee responsible, adopt recommendations and require that those recommendations be taken into account before the conclusion of a Treaty for the accession of an applicant State to the European Union. 5. When the accession negotiations have been completed, but before any agreement is signed, the draft agreement shall be submitted to Parliament for its consent, in accordance with Rule 105. In accordance with Article 49 of the Treaty on European Union, the consent of Parliament shall require the votes of a majority of its component members. Rule 88 Withdrawal from the Union If a Member State decides, pursuant to Article 50 of the Treaty on European Union, to withdraw from the Union, the matter shall be referred to the committee responsible. Rule 87 shall apply mutatis mutandis. Parliament shall decide whether to give its consent to an agreement on the withdrawal by a majority of the votes cast. Rule 89 Breach by a Member State of fundamental principles and values 1. Parliament may, on the basis of a specific report of the committee responsible drawn up in accordance with Rules 46 and 54: (a) vote on a reasoned proposal calling on the Council to act pursuant to Article 7(1) of the Treaty on European Union; (b) vote on a proposal calling on the Commission or the Member States to submit a proposal pursuant to Article 7(2) of the Treaty on European Union; (c) vote on a proposal calling on the Council to act pursuant to Article 7(3) or, subsequently, Article 7(4) of the Treaty on European Union. 2. Any request from the Council for consent in relation to a proposal submitted pursuant to Article 7(1) and (2) of the Treaty on European Union shall, along with any observations submitted by the Member State in question, be announced to Parliament and referred to the committee responsible, in accordance with Rule 105. Except in urgent and justified circumstances, Parliament shall take its decision on a proposal from the committee responsible. 3. In accordance with Article 354 of the Treaty on the Functioning of the European Union, the adoption by Parliament of decisions on proposals referred to in paragraphs 1 and 2 of this Rule shall require a two-thirds majority of the votes cast, representing a majority of its component Members. 4. Subject to the authorisation of the Conference of Presidents, the committee responsible may submit an accompanying motion for a resolution. That motion for a resolution shall set out Parliament's views on a serious breach by a Member State, on the appropriate measures to be taken and on varying or revoking those measures. 5. The committee responsible shall ensure that Parliament is kept fully informed and, where necessary, asked for its views on all follow-up measures to its consent as given pursuant to paragraph 3. The Council shall be invited to outline developments as appropriate. On a proposal from the committee responsible, drawn up with the authorisation of the Conference of Presidents, Parliament may adopt recommendations for the Council. Rule 90 Composition of Parliament In good time before the end of a parliamentary term, Parliament may, on the basis of a report drawn up by its committee responsible, in accordance with Article 14(2) of the Treaty on European Union and with Rules 46 and 54, make a proposal to modify its composition. The European Council's draft decision establishing the composition of Parliament shall be examined by Parliament in accordance with Rule 105. Rule 91 Enhanced cooperation between Member States 1. Requests for the introduction of enhanced cooperation between Member States pursuant to Article 20 of the Treaty on European Union shall be referred by the President to the committee responsible for consideration. Rule 105 shall apply. 2. The committee responsible shall verify compliance with Article 20 of the Treaty on European Union and Articles 326 to 334 of the Treaty on the Functioning of the European Union. 3. Acts subsequently proposed under enhanced cooperation, once it is established, shall be dealt with in Parliament in accordance with the same procedures as those which would have applied if no enhanced cooperation had been established. Rule 48 shall apply. CHAPTER 6 Budgetary procedures Rule 92 Multiannual financial framework Where the Council requests Parliament's consent to the proposal for a regulation laying down the multiannual financial framework, the matter shall be dealt with in accordance with Rule 105. In accordance with the first subparagraph of Article 312(2) of the Treaty on the Functioning of the European Union, Parliament's consent shall require the votes of a majority of its component Members. Rule 93 Annual budgetary procedure The committee responsible may decide to draw up any report that is deemed to be appropriate concerning the budget, having regard to the Annex to the Interinstitutional Agreement on budgetary discipline, on cooperation in budgetary matters and on sound financial management (20). Any other committee may deliver an opinion within the time limit set by the committee responsible. Rule 94 Parliament's position on the draft budget 1. Individual Members may table amendments to the Council's position on the draft budget in the committee responsible. A political group or Members reaching at least the low threshold or a committee may table in Parliament amendments to the Council's position on the draft budget. 2. Amendments shall be presented and justified in writing, bear the signature of their authors and specify the budget line to which they refer. 3. The President shall set the time limit for the tabling of amendments. 4. The committee responsible shall vote on the amendments before they are discussed in Parliament. 5. Amendments tabled in Parliament which have been rejected in the committee responsible may only be put to the vote if this has been requested in writing, before a deadline to be set by the President, by a committee or by a political group or Members reaching at least the low threshold. That deadline shall not be less than 24 hours before the start of the vote. 6. In the case of amendments to the estimates of Parliament which are similar to those already rejected by Parliament at the time when the estimates were drawn up, Parliament shall discuss them only where the committee responsible has delivered a favourable opinion. 7. Parliament shall take successive votes: \u2014 on the amendments to Council's position on the draft budget, section by section, \u2014 on a motion for a resolution concerning the draft budget. However, Rule 183(4) to (10) shall apply. 8. Articles, chapters, titles and sections of the draft budget in respect of which no amendments have been tabled shall be deemed to have been adopted. 9. In accordance with Article 314(4)(c) of the Treaty on the Functioning of the European Union, amendments shall require for adoption the votes of a majority of the component Members of Parliament. 10. If Parliament has amended the Council's position on the draft budget, the position as amended shall be forwarded to the Council and the Commission, together with the justifications and the minutes of the sitting at which the amendments were adopted. Rule 95 Budgetary conciliation 1. The President shall convene the Conciliation Committee in accordance with Article 314(4) of the Treaty on the Functioning of the European Union. 2. The delegation representing Parliament at meetings of the Conciliation Committee in the budgetary procedure shall consist of a number of members equal to that of the Council delegation. 3. Each year, prior to Parliament's vote on the Council's position, the political groups shall appoint the members of Parliament's delegation to the Conciliation Committee, preferably from amongst the members of the committee responsible for budgetary issues and other committees concerned. The delegation shall be led by the President of Parliament. The President may delegate this role to a Vice-President who has experience of budgetary matters or to the Chair of the committee responsible for budgetary issues. 4. Rule 77(2), (4), (5), (7) and (8) shall apply. 5. Where agreement on a joint text is reached within the Conciliation Committee, the matter shall be placed on the agenda of a sitting of Parliament to be held within 14 days from the date of that agreement. The joint text shall be made available to all Members. Rule 78(2) and (3) shall apply. 6. The joint text as a whole shall be put to a single vote. The vote shall be taken by roll-call vote. The joint text shall be deemed to have been approved unless it is rejected by a majority of the component Members of Parliament. 7. If Parliament approves the joint text whilst the Council rejects it, the committee responsible may table all or some of Parliament's amendments to the Council's position for a confirmation in accordance with point (d) of Article 314(7) of the Treaty on the Functioning of the European Union. The vote on the confirmation shall be placed on the agenda of a sitting of Parliament to be held within 14 days from the date of the communication by the Council of its rejection of the joint text. The amendments shall be deemed to be confirmed if they are approved by a majority of the component Members of Parliament and three fifths of the votes cast. Rule 96 Definitive adoption of the budget Where the President considers that the budget has been adopted in accordance with the provisions of Article 314 of the Treaty on the Functioning of the European Union, he or she shall declare in Parliament that the budget has been definitively adopted. The President shall arrange for its publication in the Official Journal of the European Union. Rule 97 Provisional twelfths system 1. Any decision by the Council authorising expenditure in excess of the provisional one twelfth of the budget appropriations for the preceding financial year shall be referred to the committee responsible. 2. The committee responsible may table a draft decision to reduce the expenditure referred to in paragraph 1. Parliament shall decide on it within 30 days after the adoption of the Council's decision. 3. Parliament shall act by a majority of its component Members. Rule 98 Implementation of the budget 1. Parliament shall monitor the implementation of the current year's budget. It shall entrust this task to the committees responsible for the budget and budgetary control and to the other committees concerned. 2. Each year, before its reading of the draft budget for the following financial year, Parliament shall consider the problems involved in the implementation of the current budget, where appropriate on the basis of a motion for a resolution tabled by its committee responsible. Rule 99 Discharge to the Commission in respect of implementation of the budget The provisions governing the procedure for granting discharge to the Commission in respect of the implementation of the budget in accordance with the financial provisions of the Treaty on the Functioning of the European Union and Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (21) (the \u2018Financial Regulation\u2019) are attached to these Rules as an annex (22). Rule 100 Other discharge procedures The provisions governing the procedure for granting discharge to the Commission in accordance with Article 319 of the Treaty on the Functioning of the European Union, in respect of the implementation of the budget, shall also apply to the procedure for granting discharge to: \u2014 the President of the European Parliament in respect of the implementation of the budget of the European Parliament; \u2014 the persons responsible for the implementation of the budgets of other institutions and bodies of the European Union such as the Council, the Court of Justice of the European Union, the Court of Auditors, the European Economic and Social Committee and the Committee of the Regions; \u2014 the Commission in respect of the implementation of the budget of the European Development Fund; \u2014 the bodies responsible for the budgetary management of legally independent entities which carry out Union tasks, insofar as their activities are subject to legal provisions requiring discharge by the European Parliament. Rule 101 Interinstitutional cooperation In accordance with Article 324 of the Treaty on the Functioning of the European Union, the President shall participate in regular meetings between the Presidents of the European Parliament, the Council and the Commission convened, on the initiative of the Commission, under the budgetary procedures referred to in Title II of Part Six of the Treaty on the Functioning of the European Union. The President shall take all the necessary steps to promote consultation and the reconciliation of the positions of the institutions in order to facilitate the implementation of the procedures aforementioned. The President of Parliament may delegate this task to a Vice-President who has experience of budgetary matters or to the Chair of the committee responsible for budgetary issues. CHAPTER 7 Internal budgetary procedures Rule 102 Estimates of Parliament 1. The Bureau shall draw up the preliminary draft estimates on the basis of a report prepared by the Secretary-General. 2. The President shall forward the preliminary draft estimates to the committee responsible, which shall draw up the draft estimates and report to Parliament. 3. The President shall set a time limit for tabling amendments to the draft estimates. The committee responsible shall give its opinion on these amendments. 4. Parliament shall adopt the estimates. 5. The President shall forward the estimates to the Commission and the Council. 6. The foregoing provisions shall also apply to estimates for amending budgets. Rule 103 Procedure to be applied when drawing up Parliament's estimates 1. As regards Parliament's budget, the Bureau and the committee responsible for budgetary issues shall take decisions in successive stages on: (a) the establishment plan; (b) the preliminary draft and the draft estimates. 2. The decisions concerning the establishment plan will be taken in accordance with the following procedure: (a) the Bureau shall draw up the establishment plan for each financial year; (b) a conciliation procedure between the Bureau and the committee responsible for budgetary issues shall be opened in cases where the opinion of that committee diverges from the initial decisions taken by the Bureau; (c) at the end of the procedure, the Bureau shall take the final decision on the estimates for the establishment plan, in accordance with Rule 234(3), without prejudice to decisions taken pursuant to Article 314 of the Treaty on the Functioning of the European Union. 3. As regards the estimates proper, the procedure for drawing up the estimates will begin as soon as the Bureau has taken a final decision on the establishment plan. The stages of that procedure will be those laid down in Rule 102. A conciliation procedure shall be opened in cases where the positions of the committee responsible for budgetary issues and of the Bureau are widely divergent. Rule 104 Power to incur and settle expenditure, to approve accounts and to grant discharge 1. The President shall incur and settle, or cause to be incurred and settled, the expenditure covered by the internal financial regulations issued by the Bureau after consulting the appropriate committee. 2. The President shall forward the draft annual accounts to the committee responsible. 3. On the basis of a report by the committee responsible, Parliament shall approve its accounts and decide on the granting of a discharge. CHAPTER 8 Consent procedure Rule 105 Consent procedure 1. Where Parliament is asked to give its consent to a legally binding act, the committee responsible shall submit to Parliament a recommendation to approve or reject the proposed act. The recommendation shall include citations but shall not include recitals. Amendments in committee shall be admissible only if they aim to reverse the recommendation proposed by the rapporteur. The recommendation may be accompanied by a short explanatory statement. That statement shall be the sole responsibility of the rapporteur and shall not be put to the vote. Rule 55(2) shall apply mutatis mutandis. 2. The committee responsible may also, if necessary, table a report, including a motion for a non-legislative resolution setting out the reasons why Parliament should give or refuse its consent and, where appropriate, making recommendations for the implementation of the proposed act. 3. The committee responsible shall deal with the request for consent without undue delay. If the committee responsible has not adopted its recommendation within six months after the request for consent was referred to it, the Conference of Presidents may either place the matter on the agenda for consideration at a subsequent part-session or, in duly justified cases, decide to extend the six-month period. 4. Parliament shall decide on the proposed act by means of a single vote on consent, regardless of whether the recommendation from the committee responsible is to approve or reject the act, and no amendments may be tabled. If the majority required is not obtained, the proposed act shall be deemed to have been rejected. 5. Where Parliament's consent is required, the committee responsible may, at any time, present an interim report to Parliament, including a motion for a resolution containing recommendations for the modification or the implementation of the proposed act. CHAPTER 9 Other procedures Rule 106 Procedure for delivering opinions on derogations to the adoption of the euro 1. When Parliament is consulted pursuant to Article 140(2) of the Treaty on the Functioning of the European Union, the committee responsible shall submit a report to Parliament advocating approval or rejection of the proposed act on the basis of which Parliament shall deliberate. 2. Parliament shall take a single vote on the proposed act, to which no amendments may be tabled. Rule 107 Procedures relating to dialogue between management and labour 1. The President shall refer any document drawn up by the Commission pursuant to Article 154 of the Treaty on the Functioning of the European Union or agreements reached by management and labour pursuant to Article 155(1) of that Treaty, as well as any proposals submitted by the Commission under Article 155(2) of that Treaty, to the committee responsible, for consideration. 2. Where management and labour inform the Commission of their wish to initiate the process provided for in Article 155 of the Treaty on the Functioning of the European Union, the committee responsible may draw up a report on the substantive issue in question. 3. Where management and labour have reached an agreement and have requested jointly that their agreement be implemented by a Council decision on a proposal from the Commission in accordance with Article 155(2) of the Treaty on the Functioning of the European Union, the committee responsible shall table a motion for a resolution recommending the adoption or rejection of the request. Rule 108 Procedures for scrutiny of envisaged voluntary agreements 1. Where the Commission informs Parliament of its intention to explore the use of voluntary agreements as an alternative to legislation, the committee responsible may draw up a report on the substantive issue in question pursuant to Rule 54. 2. Where the Commission announces that it intends to enter into a voluntary agreement, the committee responsible may table a motion for a resolution recommending that Parliament approve or reject the proposal, and under what conditions. Rule 109 Codification 1. When a proposal for codification of Union legislation is submitted to Parliament, it shall be referred to the committee responsible for legal affairs. That committee shall examine the proposal in accordance with the arrangements agreed at interinstitutional level (23) in order to ascertain that the proposal is a straightforward codification, with no changes of a substantive nature. 2. The committee which was responsible for the acts to be codified may, at its own request or at the request of the committee responsible for legal affairs, be asked to deliver an opinion on the desirability of codification. 3. Amendments to the text of the proposal shall be inadmissible. However, the Chair of the committee responsible for legal affairs may, at the rapporteur's request, submit, for that committee's approval, technical adaptations, provided that those adaptations do not involve any substantive change to the proposal and are necessary in order to ensure that the proposal complies with the codification rules. 4. If the committee responsible for legal affairs concludes that the proposal does not entail any substantive change to Union legislation, it shall refer it to Parliament for approval. If the committee responsible for legal affairs takes the view that the proposal entails a substantive change, it shall propose that Parliament reject the proposal. In either of those two cases, Parliament shall adopt a decision by means of a single vote, without amendment or debate. Rule 110 Recasting 1. Where a proposal recasting Union legislation is submitted to Parliament, it shall be referred to the committee responsible for legal affairs and to the committee responsible for the subject-matter. 2. The committee responsible for legal affairs shall examine the proposal in accordance with the arrangements agreed at interinstitutional level (24) in order to check that it entails no substantive changes other than those identified as such in the proposal. For the purpose of that examination, amendments to the text of the proposal shall be inadmissible. However, the second subparagraph of Rule 109(3) shall apply to provisions which remain unchanged in the recasting proposal. 3. If the committee responsible for legal affairs considers that the proposal does not entail any substantive changes other than those identified as such in the proposal, it shall inform the committee responsible for the subject matter thereof. In such a case, over and above the conditions laid down in Rules 180 and 181, amendments shall be admissible within the committee responsible for the subject-matter only if they concern those parts of the proposal which contain changes. However, amendments to parts of the proposal which remain unchanged may, by way of exception and on a case-by-case basis, be accepted by the Chair of the committee responsible for the subject matter if he or she considers that this is necessary for pressing reasons relating to the internal logic of the text or because the amendments are inextricably linked to other admissible amendments. Such reasons must be stated in a written justification to the amendments. 4. If the committee responsible for legal affairs considers that the proposal entails substantive changes other than those which have been identified as such in the proposal, it shall propose that Parliament reject the proposal and shall inform the committee responsible for the subject-matter that it has done so. In such a case the President shall ask the Commission to withdraw it. If the Commission does so, the President shall declare that the procedure in Parliament is superfluous and shall inform the Council accordingly. If the Commission does not withdraw its proposal, Parliament shall refer it back to the committee responsible for the subject-matter, which shall consider it in accordance with the normal procedure. CHAPTER 10 Delegated and implementing acts Rule 111 Delegated acts 1. When the Commission forwards a delegated act to Parliament, the President shall refer it to the committee responsible for the basic legislative act, which may decide to designate one of its members to consider one or more delegated acts. 2. During the part-session following its reception, the President shall announce to Parliament the date on which the delegated act was received in all the official languages and the period during which objections may be raised. The period in question shall commence on the date of reception. The announcement shall be published in the minutes of the sitting, together with the name of the committee responsible. 3. In accordance with the provisions of the basic legislative act and \u2014 if the committee responsible considers it appropriate to do so \u2014 after consulting any other committees concerned, the committee responsible may table a reasoned motion for a resolution objecting to the delegated act. If, 10 working days before the start of the part-session of which the Wednesday falls before and closest to the day of expiry of the deadline referred to in paragraph 5, the committee responsible has not tabled such a motion for a resolution, a political group or Members reaching at least the low threshold may table a motion for a resolution on the matter for inclusion on the agenda for the part-session referred to above. 4. Any motion for a resolution tabled in accordance with paragraph 3 shall state the reasons for Parliament's objections and may incorporate a request calling on the Commission to submit a new delegated act which takes account of Parliament's recommendations. 5. Parliament shall approve such a motion by the deadline laid down in the basic legislative act and, in accordance with the second subparagraph of Article 290(2) of the Treaty on the Functioning of the European Union, by a majority of its component Members. Where the committee responsible considers that it is appropriate to extend the deadline for raising objections to the delegated act in accordance with the provisions of the basic legislative act, the committee Chair shall notify the Council and the Commission, on behalf of Parliament, of that extension. 6. If the committee responsible recommends that, prior to the expiry of the deadline set in the basic legislative act, Parliament should declare that it has no objections to the delegated act: \u2014 the committee responsible shall inform the Chair of the Conference of Committee Chairs by means of a letter setting out its reasons and table a recommendation to that effect, \u2014 if no objections are raised at the next meeting of the Conference of Committee Chairs, or, on grounds of urgency, by written procedure, the Chair of that body shall inform the President of Parliament, who shall in turn inform the plenary as soon as possible, \u2014 if, within 24 hours following the announcement in Parliament, a political group or Members reaching at least the low threshold object to the recommendation, it shall be put to the vote, \u2014 if, within the same period, no objections are raised, the proposed recommendation shall be deemed to have been approved, \u2014 the adoption of such a recommendation shall render inadmissible any subsequent proposal objecting to the delegated act. 7. The committee responsible may, in accordance with the provisions of the basic legislative act, submit to Parliament a motion for a resolution revoking, in full or in part, that delegation of powers or opposing the tacit extension of that delegation of powers. In accordance with the second subparagraph of Article 290(2) of the Treaty on the Functioning of the European Union, a decision to revoke the delegation of powers shall require the votes of a majority of Parliament's component Members. 8. The President shall inform the Council and Commission of the positions taken under this Rule. Rule 112 Implementing acts and measures 1. When the Commission forwards a draft implementing act or measure to Parliament, the President shall refer it to the committee responsible for the basic legislative act, which may decide to designate one of its members to consider one or more draft implementing acts or measures. 2. The committee responsible may table a reasoned motion for a resolution stating that a draft implementing act or measure goes beyond the implementing powers conferred in the basic legislative act or is not consistent with Union law in other respects. 3. The motion for a resolution may incorporate a request to the Commission to withdraw the draft implementing act or measure, to amend it in keeping with the objections raised by Parliament, or to submit a new legislative proposal. The President shall inform the Council and the Commission of the decision taken. 4. If the implementing acts envisaged by the Commission fall under the regulatory procedure with scrutiny provided for by Council Decision 1999/468/EC (25), the following additional provisions shall apply: (a) the time for scrutiny shall start to run when the draft implementing measure has been submitted to Parliament in all the official languages. Where the shorter time limit for scrutiny provided for in Article 5a(5)(b) of Decision 1999/468/EC applies, and in the urgent cases provided for in Article 5a(6) of that Decision, the time for scrutiny shall, unless the Chair of the committee responsible objects, start to run from the date of receipt by Parliament of the final draft implementing measure in the language versions submitted to the members of the committee set up in accordance with that Decision. Rule 167 shall not apply in the two instances mentioned in the previous sentence; (b) if the draft implementing measure is based on paragraph 5 or 6 of Article 5a of Decision 1999/468/EC, which prescribes curtailed time limits for opposition by Parliament, a motion for a resolution opposing the adoption of the draft measure may be tabled by the Chair of the committee responsible if that committee has not been able to meet in the time available; (c) Parliament, acting by a majority of its component Members, may adopt a resolution opposing the adoption of the draft implementing measure and indicating that the draft exceeds the implementing powers conferred in the basic act, is not compatible with the aim or the content of the basic act or does not respect the principles of subsidiarity or proportionality. If, 10 working days prior to the start of the part-session of which the Wednesday falls before and closest to the day of expiry of the deadline for opposing the adoption of the draft implementing measure, the committee responsible has not tabled a motion for such a resolution, a political group or Members reaching at least the low threshold may table a motion for a resolution on the matter for inclusion on the agenda for the part-session referred to above; (d) if the committee responsible recommends, by means of a letter to the Chair of the Conference of Committee Chairs setting out its reasons, that Parliament should declare that it has no objections to the proposed measure prior to the expiry of the normal time limit laid down in Article 5a(3)(c) and/or Article 5a(4)(e) of Decision 1999/468/EC, the procedure provided for in Rule 111(6) shall apply (26). Rule 113 Consideration under the associated committee procedure or the joint committee procedure 1. If the basic legislative act was adopted by Parliament under the procedure provided for in Rule 57, the following additional provisions shall apply to the consideration of the delegated acts or draft implementing acts or measures: \u2014 the delegated act or draft implementing act or measure shall be forwarded to the committee responsible and to the associated committee, \u2014 the Chair of the committee responsible shall set a deadline by which the associated committee may draw up proposals on matters falling within its exclusive competence or within the joint competence of the two committees, \u2014 if the delegated act or draft implementing act or measure falls mainly within the exclusive competence of the associated committee, the committee responsible shall accept its proposals without a vote; if the committee responsible fails to respect this rule, the President may authorise the associated committee to table a motion for a resolution in plenary. 2. If the basic legislative act was adopted by Parliament under the procedure provided for in Rule 58, the following additional provisions shall apply to the consideration of delegated acts and draft implementing acts or measures: \u2014 upon receipt of the delegated act or draft implementing act or measure, the President shall determine which committee is responsible or which committees are jointly responsible for it, in accordance with the criteria laid down in Rule 58 and with any agreements reached between the Chairs of the committees concerned, \u2014 if a delegated act or a draft implementing act or measure has been forwarded for consideration under the joint committee procedure, each committee may request that a joint meeting be convened to consider a motion for a resolution. If the Chairs of the committees concerned fail to reach agreement, the joint meeting shall be convened by the Chair of the Conference of Committee Chairs. TITLE III EXTERNAL RELATIONS CHAPTER 1 International agreements Rule 114 International agreements 1. When it is intended to open negotiations on the conclusion, renewal or amendment of an international agreement, the committee responsible may decide to draw up a report or otherwise monitor the preparatory phase. It shall inform the Conference of Committee Chairs of its decision. 2. The committee responsible shall, as soon as possible, ascertain from the Commission the chosen legal basis for concluding the international agreements referred to in paragraph 1. The committee responsible shall verify that chosen legal basis in accordance with Rule 40. 3. Parliament may, on a proposal from the committee responsible, a political group or Members reaching at least the low threshold, ask the Council not to authorise the opening of negotiations until Parliament has stated its position on the proposed negotiating mandate on the basis of a report from the committee responsible. 4. At any stage of the negotiations and from the end of the negotiations to the conclusion of the international agreement, Parliament may, on the basis of a report from the committee responsible, drawn up by that committee on its own initiative or after considering any relevant proposal tabled by a political group or Members reaching at least the low threshold, adopt recommendations to the Council, the Commission or the Vice President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy and require them to be taken into account before the conclusion of that agreement. 5. Requests by the Council for Parliament's consent or opinion shall be referred by the President to the committee responsible for consideration in accordance with Rule 105 or Rule 48(1). 6. At any time before Parliament votes on a request for consent or opinion, the committee responsible or at least one-tenth of Parliament's component Members may propose that Parliament seek an opinion from the Court of Justice on the compatibility of an international agreement with the Treaties. Before Parliament votes on that proposal, the President may request the opinion of the committee responsible for legal affairs, which shall report its conclusions to Parliament. If Parliament approves the proposal to seek an opinion from the Court of Justice, the vote on a request for consent or opinion shall be adjourned until the Court has delivered its opinion. 7. Where the Council requests that Parliament give its consent to the conclusion, renewal or amendment of an international agreement, Parliament shall decide by a single vote in accordance with Rule 105. If Parliament declines to give its consent, the President shall inform the Council that the agreement in question cannot be concluded, renewed or amended. Without prejudice to Rule 105(3), Parliament may decide, on the basis of a recommendation from the committee responsible, to postpone its decision on the consent procedure for no longer than one year. 8. Where the Council requests that Parliament gives its opinion on the conclusion, renewal or amendment of an international agreement, no amendments to the text of the agreement shall be admissible. Without prejudice to Rule 181(1), amendments to the draft Council decision shall be admissible. If that opinion adopted by Parliament is unfavourable, the President shall ask the Council not to conclude the agreement in question. 9. The Chairs and rapporteurs of the committee responsible, and of any associated committees, shall jointly check that, in accordance with Article 218(10) of the Treaty on the Functioning of the European Union, the Council, the Commission and the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy immediately and regularly provide Parliament with full information, if necessary on a confidential basis, at all stages of the preparations for the negotiation, the negotiation and the conclusion of international agreements, including information on the draft and the finally adopted text of negotiating directives, as well as information relating to the implementation of those agreements. Rule 115 Provisional application or suspension of the application of international agreements or establishment of the Union's position in a body set up by an international agreement Where the Commission or the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy informs Parliament and the Council of its intention to propose the provisional application or suspension of an international agreement, Parliament may invite the Council, the Commission or the Vice-President/High Representative to make a statement, following which there shall be a debate. Parliament may issue recommendations on the basis of a report by the committee responsible or pursuant to Rule 118, which may include, in particular, a request to the Council not to provisionally apply an agreement until the Parliament has given consent. That procedure shall also apply when the Commission or the Vice-President/High Representative proposes positions to be adopted on the Union's behalf in a body set up by an international agreement. CHAPTER 2 External representation of the Union and the common foreign and security policy Rule 116 Special representatives 1. Where the Council intends to appoint a special representative under Article 33 of the Treaty on European Union, the President, at the request of the committee responsible, shall invite the Council to make a statement, and to answer questions, concerning the mandate, the objectives and other relevant matters relating to the tasks and role to be performed by the special representative. 2. After the special representative has been appointed, but before he or she has taken up that position, he or she may be invited to appear before the committee responsible to make a statement and answer questions. 3. Within two months after the hearing, the committee responsible may make recommendations to the Council, to the Commission or to the Vice President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy relating directly to the appointment. 4. The special representative shall be invited to keep Parliament fully and regularly informed concerning the practical implementation of the mandate. Rule 117 International representation 1. Before appointment, the nominee for a post of head of a Union external delegation may be invited to appear before the committee responsible in order to make a statement and to answer questions. 2. Within two months of the hearing provided for in paragraph 1, the committee responsible may adopt a resolution or make a recommendation, as appropriate, relating directly to the appointment. CHAPTER 3 Recommendations on the Union's external action Rule 118 Recommendations on the Union's external policies 1. The committee responsible may draw up draft recommendations for the Council, for the Commission or for the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy on subjects under Title V of the Treaty on European Union (the Union's external action), or in cases where an international agreement falling within the scope of Rule 114 has not been referred to Parliament or Parliament has not been informed thereof under Rule 115. 2. In urgent cases, the President may authorise an emergency meeting of the committee concerned. 3. During the procedure for adopting those draft recommendations at committee stage, it shall be necessary for a written text to be put to the vote. 4. In the urgent cases referred to in paragraph 2, Rule 167 shall not apply at committee stage, and oral amendments shall be admissible. Members may not object to oral amendments being put to the vote in committee. 5. The draft recommendations drawn up by the committee shall be included on the agenda for the next part-session. In urgent cases decided upon by the President, recommendations may be included on the agenda for a current part-session. 6. Recommendations shall be deemed to have been adopted unless, before the beginning of the part-session, a political group or Members reaching at least the low threshold submit a written objection. Where such an objection is submitted, the committee's draft recommendations shall be included on the agenda of the same part-session. Such recommendations shall be the subject of a debate, and any amendment tabled by a political group or Members reaching at least the low threshold shall be put to the vote. Rule 119 Consultation of, and provision of information to, Parliament within the framework of the common foreign and security policy 1. When Parliament is consulted pursuant to Article 36 of the Treaty on European Union, the matter shall be referred to the committee responsible, which may draw up draft recommendations pursuant to Rule 118. 2. The committees concerned shall seek to ensure that the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy provides them, regularly and in a timely manner, with information on the development and implementation of the Union's common foreign and security policy, on the costs envisaged each time that a decision entailing expenditure is adopted under that policy and on any other financial considerations relating to the implementation of actions under that policy. Exceptionally, at the request of the Vice-President/High Representative, a committee may decide to hold its proceedings in camera. 3. Twice a year, a debate shall be held on the consultative document drawn up by the Vice-President/High Representative on the main aspects and basic choices of the common foreign and security policy, including the common security and defence policy and the financial implications for the Union budget. The procedures laid down in Rule 132 shall apply. 4. The Vice-President/High Representative shall be invited to every plenary debate that involves either foreign, security or defence policy. Rule 120 Breach of human rights At each part-session, the committees responsible may, without requiring authorisation, each table a motion for a resolution under the same procedure as that laid down in Rule 118(5) and (6) concerning cases of breaches of human rights. TITLE IV TRANSPARENCY OF BUSINESS Rule 121 Transparency of Parliament's activities 1. Parliament shall ensure that its activities are conducted with the utmost transparency, in accordance with the second paragraph of Article 1 of the Treaty on European Union, Article 15 of the Treaty on the Functioning of the European Union and Article 42 of the Charter of Fundamental Rights of the European Union. 2. Debates in Parliament shall be public. 3. Committees shall normally meet in public. At the latest when the agenda for a meeting is adopted, they may, however, decide to divide that agenda into items open to the public and items closed to the public. However, if a meeting is held in camera, the committee may decide to make documents from the meeting available for public access. Rule 122 Public access to documents 1. Any citizen of the Union and any natural or legal person residing or having its registered office in a Member State has a right of access to Parliament documents in accordance with Article 15 of the Treaty on the Functioning of the European Union. Such access to Parliament documents is subject to the principles, conditions and limits laid down in Regulation (EC) No 1049/2001. Access to Parliament documents shall as far as possible be granted to other natural or legal persons in the same way. 2. For the purpose of access to documents, the term \u2018Parliament documents\u2019 means any content within the meaning of Article 3(a) of Regulation (EC) No 1049/2001 which has been drawn up or received by officers of Parliament within the meaning of Title I, Chapter 2, of these Rules, by Parliament's governing bodies, committees or interparliamentary delegations, or by Parliament's Secretariat. In accordance with Article 4 of the Statute for Members of the European Parliament, documents drawn up by individual Members or political groups are Parliament documents for the purposes of access to documents only if they are tabled in accordance with the Rules of Procedure. The Bureau shall lay down rules to ensure that all Parliament documents are registered. 3. Parliament shall establish a public register website for Parliament documents. Legislative documents and certain other categories of documents shall, in accordance with Regulation (EC) No 1049/2001, be made directly accessible through Parliament's public register website. References to other Parliament documents shall, as far as possible, be included in Parliament's public register website. The categories of documents which are to be directly accessible through Parliament's public register website shall be set out in a list adopted by the Bureau and published on Parliament's public register website. That list shall not restrict the right of access to documents not falling within the categories listed; those documents may be made available on written application in accordance with Regulation (EC) No 1049/2001. The Bureau shall adopt rules for access to documents, pursuant to Regulation (EC) No 1049/2001, which shall be published in the Official Journal of the European Union 4. The Bureau shall designate the bodies responsible for the handling of initial applications (Article 7 of Regulation (EC) No 1049/2001) and for the adoption of decisions on confirmatory applications (Article 8 of that Regulation) and on applications for access to sensitive documents (Article 9 of that Regulation). 5. One of the Vice-Presidents shall be responsible for supervising the handling of applications for access to documents. 6. The Bureau shall adopt the annual report referred to in Article 17(1) of Regulation (EC) No 1049/2001. 7. Parliament's committee responsible shall regularly examine the transparency of Parliament's activities and shall submit a report with its conclusions and recommendations to the plenary. The committee responsible may also examine and evaluate the reports adopted by the other institutions and agencies in accordance with Article 17 of Regulation (EC) No 1049/2001. 8. The Conference of Presidents shall designate Parliament's representatives on the interinstitutional committee established pursuant to Article 15(2) of Regulation (EC) No 1049/2001. Rule 123 Access to Parliament 1. Access badges for Members, Members' assistants and third persons shall be issued on the basis of the rules laid down by the Bureau. Those rules shall also govern the use and withdrawal of access badges. 2. Badges shall not be issued to individuals within a Member's entourage who fall within the scope of the Agreement between the European Parliament and the European Commission on the transparency register. 3. Entities listed in the transparency register, and their representatives who have been issued with long-term access badges to the European Parliament must respect: \u2014 the Code of Conduct for Registrants annexed to the agreement, \u2014 the procedures and other obligations laid down by the agreement, and \u2014 the provisions implementing this Rule. Without prejudice to the applicability of the general rules governing the withdrawal or temporary de-activation of long-term access badges, and unless there are significant arguments to the contrary, the Secretary-General shall, with the authorisation of the Quaestors, withdraw or de- activate a long-term access badge where its holder has been disbarred from the transparency register for a breach of the Code of Conduct for Registrants, has been guilty of a serious breach of the obligations laid down in this paragraph, or has refused, without offering a sufficient justification, to comply with a formal summons to attend a hearing or committee meeting or to cooperate with a committee of inquiry. 4. The Quaestors may determine to what extent the Code of Conduct referred to in paragraph 3 is applicable to persons who, whilst in possession of a long-term access badge, do not fall within the scope of the agreement. 5. The Bureau, acting on a proposal from the Secretary-General, shall lay down the measures needed to implement the transparency register, in accordance with the provisions of the agreement on the establishment of that register. TITLE V RELATIONS WITH OTHER INSTITUTIONS AND BODIES CHAPTER 1 Appointments Rule 124 Election of the President of the Commission 1. When the European Council proposes a candidate for President of the Commission, the President shall request the candidate to make a statement and to present his or her political guidelines to Parliament. The statement shall be followed by a debate. The European Council shall be invited to take part in the debate. 2. In accordance with Article 17(7) of the Treaty on European Union, Parliament shall elect the President of the Commission by a majority of its component Members. The vote shall be taken by secret ballot. 3. If the candidate is elected, the President shall inform the Council accordingly, asking it and the President-elect of the Commission to propose, by common accord, the nominees for the various posts of Commissioners. 4. If the candidate does not obtain the required majority, the President shall invite the European Council to propose a new candidate within one month for election in accordance with the same procedure. Rule 125 Election of the Commission 1. The President shall invite the President-elect of the Commission to inform Parliament about the allocation of responsibilities (portfolios) in the proposed College of Commissioners in accordance with the political guidelines of the President-elect. 2. The President shall, after consulting the President-elect of the Commission, request the nominees proposed by the President-elect of the Commission and by the Council for the various posts of Commissioner to appear before the appropriate committees or bodies according to their prospective fields of responsibility. 3. The hearings shall be conducted by the committees. Exceptionally, a hearing may be carried out in a different format when the responsibilities of a Commissioner-designate are primarily horizontal in nature, provided that such a hearing involves the committees responsible. The hearings shall be held in public. 4. The appropriate committee or committees shall invite the Commissioner-designate to make a statement and to answer questions. The hearings shall be organised in such a way as to enable Commissioners-designate to disclose to Parliament all relevant information. Provisions relating to the organisation of such hearings shall be laid down in an annex to these Rules of Procedure (27). 5. The President-elect shall be invited to present the college of Commissioners and their programme at a sitting of Parliament. The President of the European Council and the President of the Council shall be invited to attend. The statement shall be followed by a debate. 6. In order to wind up that debate, a political group or Members reaching at least the low threshold may table a motion for a resolution. Rule 132(3) to (8) shall apply. 7. Following the vote on the motion for a resolution, Parliament shall elect or reject the Commission by a majority of the votes cast, by roll call. Parliament may defer the vote until the next sitting. 8. The President shall inform the Council of the election or rejection of the Commission. 9. In the event of a substantial portfolio change or a change in the composition of the Commission during the Commission's term of office, the Commissioners concerned or any other Commissioners designate shall be invited to participate in a hearing held in accordance with paragraphs 3 and 4. 10. In the event of a change in the Commissioner's portfolio or in the financial interests of a Commissioner during his or her term of office, this situation shall be subject to scrutiny by Parliament in accordance with Annex VII. If a conflict of interests is identified during a Commissioner's term of office and the President of the Commission fails to implement Parliament's recommendations for resolving that conflict of interests, Parliament may ask the President of the Commission to withdraw confidence in the Commissioner in question, pursuant to paragraph 5 of the Framework agreement on relations between the European Parliament and the European Commission and, where appropriate, to take action with a view to depriving the Commissioner in question of his or her right to a pension or other benefits in lieu of pension in accordance with the second paragraph of Article 245 of the Treaty on the Functioning of the European Union. Rule 126 Multiannual programming Upon the appointment of a new Commission, the Parliament, the Council and the Commission will, pursuant to paragraph 5 of the Interinstitutional Agreement on Better Law-Making, exchange views and agree on joint conclusions on multiannual programming. To that effect, and before negotiating with the Council and the Commission on the joint conclusions on multiannual programming, the President shall hold an exchange of views with the Conference of Presidents regarding the principal policy objectives and priorities for the new legislative term. This exchange of views will take into consideration, inter alia, the priorities presented by the President-elect of the Commission, as well as the replies given by Commissioners-designate during the hearings provided for in Rule 125. Before signing the joint conclusions, the President shall seek the approval of the Conference of Presidents. Rule 127 Motion of censure on the Commission 1. A motion of censure in respect of the Commission may be submitted to the President by one tenth of the component Members of Parliament. If a motion of censure has been voted on in the preceding two months, any new one tabled by less than one fifth of the component Members of Parliament shall be inadmissible. 2. The motion shall be called a \u2018motion of censure\u2019 and shall state reasons. It shall be forwarded to the Commission. 3. The President shall announce to Members that a motion of censure has been tabled immediately after he or she has received it. 4. The debate on censure shall not take place until at least 24 hours after the receipt of a motion of censure is announced to Members. 5. The vote on the motion shall be by roll call and shall not be taken until at least 48 hours after the beginning of the debate. 6. Without prejudice to paragraphs 4 and 5, the debate and the vote shall take place, at the latest, during the part-session following the submission of the motion. 7. In accordance with Article 234 of the Treaty on the Functioning of the European Union, the motion of censure shall be adopted if it secures a two-thirds majority of the votes cast, representing a majority of the component Members of Parliament. The President of the Council and the President of the Commission shall be notified of the result of the vote. Rule 128 Nomination of Judges and Advocates-General at the Court of Justice of the European Union On a proposal from the committee responsible, Parliament shall appoint its nominee to the panel of seven persons charged with scrutinising the suitability of candidates to hold the office of Judge or Advocate-General of the Court of Justice and the General Court. The committee responsible shall select the nominee that it wishes to propose by holding a vote by simple majority. For that purpose, the coordinators of that committee shall establish a shortlist of candidates. Rule 129 Appointment of the Members of the Court of Auditors 1. Candidates nominated as Members of the Court of Auditors shall be invited to make a statement before the committee responsible and to answer questions put by its members. The committee shall vote on each nomination separately by secret ballot. 2. The committee responsible shall make a recommendation to Parliament as to whether the nomination should be approved. 3. The vote in plenary shall take place within two months of receipt of the nomination unless Parliament, at the request of the committee responsible, a political group or Members reaching at least the low threshold, decides otherwise. Parliament shall vote on each nomination separately by secret ballot. 4. If the opinion, adopted by Parliament, on an individual nomination, is unfavourable, the President shall ask the Council to withdraw its nomination and to submit a new nomination to Parliament. Rule 130 Appointment of the Members of the Executive Board of the European Central Bank 1. The candidate nominated as President, Vice-President or Member of the Executive Board of the European Central Bank shall be invited to make a statement before the committee responsible and to answer questions put by its members. 2. The committee responsible shall make a recommendation to Parliament as to whether the nomination should be approved. 3. The vote shall take place within two months of receipt of the nomination unless Parliament, at the request of the committee responsible, a political group or Members reaching at least the low threshold, decides otherwise. Parliament shall vote on each nomination separately, by secret ballot. 4. If the opinion adopted by Parliament on a nomination is unfavourable, the President shall ask for the withdrawal of the nomination and for the submission to Parliament of a new nomination. Rule 131 Appointments to the economic governance bodies 1. This Rule shall apply to the appointment of: \u2014 the Chair and the Vice-Chair of the Supervisory Board of the European Central Bank, \u2014 the Chair, the Vice-Chair and the full-time members of the Single Resolution Board of the Single Resolution Mechanism, \u2014 the Chairs and Executive Directors of the European Supervisory Authority (European Banking Authority, European Securities and Markets Authority, European Insurance and Occupational Pensions Authority), and \u2014 the Managing Director and Deputy Managing Director of the European Fund for Strategic Investments. 2. Each candidate shall be invited to make a statement before the committee responsible and to answer questions put by its members. 3. The committee responsible shall make a recommendation to Parliament on each proposal for appointment. 4. The vote shall take place within two months of receipt of the proposal for appointment unless Parliament, at the request of the committee responsible, a political group or Members reaching at least the low threshold, decides otherwise. Parliament shall vote on each appointment separately, by secret ballot. 5. If the decision adopted by Parliament on a proposal for appointment is unfavourable, the President shall ask for its withdrawal and for the submission to Parliament of a new proposal. CHAPTER 2 Statements Rule 132 Statements by the Commission, Council and European Council 1. Members of the Commission, the Council and the European Council may, at any time, ask the President of Parliament for permission to make a statement. The President of the European Council shall make a statement after each of its meetings. The President of Parliament shall decide when the statement may be made and whether it is to be followed by a full debate or by a period of brief and concise questions from Members lasting 30 minutes. 2. When placing a statement with debate on its agenda, Parliament shall decide whether or not to wind up the debate with a resolution. It shall not do so if a report on the same matter is scheduled for the same or the next part-session, unless the President, for exceptional reasons, proposes otherwise. If Parliament decides to wind up a debate with a resolution, a committee, a political group or Members reaching at least the low threshold may table a motion for a resolution. 3. Motions for resolutions shall be put to the vote at the earliest possible voting time. The President shall decide on any exceptions. Explanations of vote shall be admissible. 4. A joint motion for a resolution shall replace the motions for resolutions tabled previously by its signatories, but not those tabled by other committees, political groups or Members. 5. If a joint motion for a resolution is tabled by political groups representing a clear majority, the President may put that motion to the vote first. 6. After a resolution has been adopted, no further motions may be put to the vote unless the President, in exceptional circumstances, decides otherwise. 7. The author or authors of a motion for a resolution tabled under paragraph 2 or Rule 144(2) shall be entitled to withdraw it before the final vote. 8. A motion for a resolution which has been withdrawn may be taken over and retabled immediately by a group, a committee or the same number of Members as is entitled to table it. This paragraph and paragraph 7 shall also apply to resolutions tabled under Rules 111 and 112. Rule 133 Statements explaining Commission decisions The President shall invite the President of the Commission, the Commissioner responsible for relations with the European Parliament or, by agreement, another Commissioner, to make a statement to Parliament, after each meeting of the Commission, explaining the main decisions taken, unless, for timetabling reasons or because of the relative political relevance of the subject- matter, the Conference of Presidents decides that this is not necessary. The statement shall be followed by a debate of at least 30 minutes in which Members may put brief and concise questions. Rule 134 Statements by the Court of Auditors 1. In the context of the discharge procedure or of Parliament's activities in the sphere of budgetary control, the President of the Court of Auditors may be invited to make a statement to Parliament in order to present the comments contained in the Annual Report, special reports or opinions of the Court, or in order to explain the Court's work programme. 2. Parliament may decide to hold a separate debate, with the participation of the Commission and the Council, on any questions raised in such statements in particular when irregularities in financial management have been reported. Rule 135 Statements by the European Central Bank 1. The President of the European Central Bank shall be invited to present to Parliament the Bank's Annual Report on the activities of the European System of Central Banks and on the monetary policy of both the previous and the current year. 2. This presentation shall be followed by a general debate. 3. The President of the European Central Bank shall be invited to attend meetings of the committee responsible at least four times a year in order to make a statement and to answer questions. 4. If they or Parliament so request, the President, Vice-President and other Members of the Executive Board of the European Central Bank shall be invited to attend additional meetings. 5. A verbatim report of the proceedings under paragraphs 3 and 4 shall be drawn up. CHAPTER 3 Parliamentary questions Rule 136 Questions for oral answer with debate 1. Questions to the Council, to the Commission or to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy may be put by a committee, a political group or Members reaching at least the low threshold, accompanied with a request that they be placed on the agenda of Parliament. Such questions shall be submitted in writing to the President. The President shall immediately refer them to the Conference of Presidents. The Conference of Presidents shall decide whether or not to place those questions on the draft agenda in accordance with Rule 157. Questions not placed on Parliament's draft agenda within three months of being submitted shall lapse. 2. Questions to the Commission and to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy shall be referred to the addressee at least one week before the sitting on the agenda of which they are to appear and questions to the Council at least three weeks before that date. 3. Where the questions concern the common security and defence policy, the time limits provided for in paragraph 2 shall not apply, and the reply must be given sufficiently promptly for Parliament to be kept properly informed. 4. A Member designated in advance by the questioners shall move the question in Parliament. If that Member is not present, the question shall lapse. The addressee shall answer. 5. Rule 132(2) to (8) concerning the tabling and voting of motions for resolutions shall apply mutatis mutandis. Rule 137 Question Time 1. Question Time with the Commission may be held at each part-session for a duration of up to 90 minutes on one or more specific horizontal themes to be decided upon by the Conference of Presidents one month in advance of the part-session. 2. The Commissioners invited to participate by the Conference of Presidents shall have a portfolio related to the specific horizontal theme or themes on which questions are to be put to them. The number of Commissioners to be invited shall be limited to two per part-session. However, it shall be possible to invite a third Commissioner, depending on the specific horizontal theme or themes chosen for the Question Time. 3. In accordance with guidelines established by the Conference of Presidents, specific question hours may be held with the Council, with the President of the Commission, with the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy and with the President of the Eurogroup. 4. Question time shall not be specifically allocated in advance. The President shall, as far as possible, ensure that Members that hold different political views and that come from different Member States are given the opportunity to put a question in turn. 5. The Member shall be given one minute in which to formulate the question and the Commissioner two minutes in which to reply. That Member may put a supplementary question, lasting no longer than 30 seconds and having a direct bearing on the main question. The Commissioner shall then be given two minutes in which to give a supplementary reply. Questions and supplementary questions must be directly related to the specific horizontal theme decided under paragraph 1. The President may rule on their admissibility. Rule 138 Questions for written answer 1. Any Member, a political group or a committee may put questions for written answer to the President of the European Council, to the Council, to the Commission or to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy in accordance with criteria laid down in an annex to these Rules of Procedure (28). The content of questions shall be the sole responsibility of their authors. 2. Questions shall be submitted in electronic form to the President. Issues concerning the admissibility of a question shall be decided by the President. The President's decision shall not be based exclusively on the provisions of the annex referred to in paragraph 1 but on the provisions of these Rules of Procedure in general. The questioner shall be notified of the President's reasoned decision. 3. Each Member, political group or committee may submit a maximum of twenty questions over a rolling period of three months. As a general rule, the questions shall be answered by the addressee within six weeks of being forwarded to it. However, any Member, political group or committee may every month designate one of its questions as a \u2018priority question\u2019 to be answered by the addressee within three weeks of being forwarded to it. 4. A question may be supported by Members other than the author. Such questions shall only count towards the author's and not the supporter's maximum number of questions under paragraph 3. 5. If a question was not answered by the addressee within the deadline provided for in paragraph 3, the committee responsible may decide to place it on the agenda for its next meeting. 6. Questions, and answers, including their related annexes, thereto, shall be published on Parliament's website. Rule 139 Major interpellations for written answer 1. Major interpellations shall consist of questions for written answer put to the Council, the Commission or the Vice-President of the Commission/High-Representative of the Union for Foreign Affairs and Security Policy by a political group. 2. The major interpellation shall be of general interest and shall be submitted in writing to the President. It shall not exceed 500 words. Provided that the major interpellation is in accordance with the provisions of the Rules in general, the President shall immediately transmit it to the addressee for a written answer. 3. There shall be maximum 30 major interpellations every year. The Conference of Presidents shall ensure a fair distribution of such interpellations among the political groups, and no political group shall submit more than one per month. 4. If the addressee fails to answer the major interpellation within six weeks of being forwarded to it, the interpellation shall, at the request of the author, be placed on the final draft agenda of Parliament in accordance with the procedure provided for in Rule 157 and subject to paragraph 6. 5. On receipt of the written answer, if Members or a political group or groups reaching at least the medium threshold so request, the major interpellation shall be placed on the final draft agenda of Parliament in accordance with the procedure provided for in Rule 157 and subject to paragraph 6. 6. The number of major interpellations debated during the same part-session shall not exceed three. If debates are requested for more than three major interpellations during the same part-session, the Conference of Presidents shall include them in the final draft agenda in the order it has received those requests for debate. 7. A Member designated in advance by the author, or by those requesting the debate in accordance with paragraph 5, shall move the major interpellation in Parliament. If that Member is not present, the major interpellation shall lapse. The addressee shall answer. Rule 132(2) to (8) concerning the tabling of, and voting on, motions for resolutions shall apply mutatis mutandis. 8. Such interpellations, as well as the answers to them, shall be published on Parliament's website. Rule 140 Questions for written answer to the European Central Bank 1. Any Member may put a maximum of six questions for written answer per month to the European Central Bank in accordance with criteria laid down in an annex to these Rules of Procedure (29). The content of questions shall be the sole responsibility of their authors. 2. Such questions shall be submitted in writing to the Chair of the committee responsible. On receiving such questions, the Chair of the committee responsible shall notify them to the European Central Bank. Issues concerning the admissibility of a question shall be decided by the Chair of the committee responsible. The questioner shall be notified of any such decision. 3. Such questions, as well as the answers to them, shall be published on Parliament's website. 4. If a question for written answer has not received a reply within six weeks, it may, at the request of its author, be included on the agenda for the next meeting of the committee responsible with the President of the European Central Bank. Rule 141 Questions for written answer concerning the Single Supervisory Mechanism and the Single Resolution Mechanism 1. Rule 140 (1), (2) and (3) shall, with regard to questions for written answer concerning the Single Supervisory Mechanism and the Single Resolution Mechanism, apply mutatis mutandis. The number of such questions shall be subtracted from the maximum of six per month provided for in Rule 140(1). 2. If a question for written answer has not received a reply within five weeks, it may, at the request of its author, be included on the agenda for the next meeting of the committee responsible with the Chair of the Board of the addressee. CHAPTER 4 Reports of other institutions and bodies Rule 142 Annual and other reports of other institutions or bodies 1. Annual and other reports of other institutions or bodies in respect of which the Treaties provide for consultation of Parliament, or in respect of which other legal provisions require an opinion by Parliament, shall be dealt with in a report submitted to the plenary. 2. Annual and other reports of other institutions or bodies not covered by paragraph 1 shall be referred to the committee responsible, which shall examine them, and which may submit a short motion for resolution to Parliament or propose the drawing up of a report under Rule 54 if it considers that Parliament should take a position on an important matter covered in the reports. CHAPTER 5 Resolutions and recommendations Rule 143 Motions for resolutions 1. Any Member may table a motion for a resolution on a matter falling within the spheres of activity of the European Union. That motion may not be more than 200 words long. 2. Such a motion may not: \u2014 contain any decision on matters for which other specific procedures and competences are laid down in these Rules of Procedure, in particular Rule 47, or \u2014 deal with the subject of ongoing proceedings in Parliament. 3. Each Member may table no more than one such motion per month. 4. The motion for a resolution shall be submitted to the President, who shall verify whether it fulfils the applicable criteria. If the President declares the motion to be admissible, he or she shall announce it in plenary and refer it to the committee responsible. 5. The committee responsible shall decide what procedure is to be followed, which may include the combination of the motion for a resolution with other motions for a resolution or with reports; the adoption of an opinion, which may take the form of a letter; or the drawing up of a report under Rule 54. The committee responsible may also decide not to follow up the motion for a resolution. 6. The authors of a motion for a resolution shall be informed of the decisions of the President, of the committee and of the Conference of Presidents. 7. The report referred to in paragraph 5 shall contain the text of the motion for a resolution. 8. Opinions in the form of a letter referred to in paragraph 5 that are addressed to other institutions of the European Union shall be forwarded to them by the President. 9. A motion for a resolution tabled in accordance with paragraph 1 may be withdrawn by its author or authors or by its first signatory before the committee responsible has decided, in accordance with paragraph 5, to draw up a report on it. Once that motion for a resolution has been thus taken over by the committee responsible, only that committee shall have the power to withdraw it. The committee responsible shall retain that power of withdrawal until the opening of the final vote in plenary. Rule 144 Debates on cases of breaches of human rights, democracy and the rule of law 1. A committee, an interparliamentary delegation, a political group or Members reaching at least the low threshold may ask the President in writing for a debate to be held on an urgent case of a breach of human rights, democracy and the rule of law. 2. The Conference of Presidents shall draw up a list of subjects to be included in the final draft agenda for the next debate on cases of breaches of human rights, democracy and the rule of law on the basis of the requests referred to in paragraph 1 and in accordance with the provisions of Annex IV. The total number of subjects included in the agenda shall not exceed three, including sub-chapters. In accordance with Rule 158, Parliament may abandon a topic due to be debated and replace it with an unscheduled topic. Motions for resolutions on the subjects chosen may be tabled by a committee, a political group or Members reaching at least the low threshold by the evening of the day on which the agenda is adopted. The President shall set the precise deadline for tabling such motions for resolutions. 3. The total speaking time for the political groups and non-attached Members shall be allocated in accordance with the procedure laid down in Rule 171(4) and (5), up to a maximum time for debates of 60 minutes per part-session. Any time remaining after the time required to introduce the motions for resolutions and any speaking time allocated to the Commission and Council has been deducted shall be divided among the political groups and the non-attached Members. 4. At the end of the debate there shall be an immediate vote. Rule 194, concerning explanations of vote, shall not apply. Votes taken under this Rule may be organised on a collective basis under the responsibility of the President and the Conference of Presidents. 5. If two or more motions for resolutions are tabled on the same subject, the procedure set out in Rule 132(4) and (5) shall apply. 6. The President and the Chairs of the political groups may decide that a motion for a resolution is to be put to the vote without debate. Such a decision shall require the unanimous agreement of all the Chairs of the political groups. The provisions of Rules 197 and 198 do not apply to motions for resolutions included on the agenda for a debate on cases of breaches of human rights, democracy and the rule of law. Motions for resolutions are tabled for a debate on cases of breaches of human rights, democracy and the rule of law only after the list of subjects has been adopted. Motions for resolutions that cannot be dealt with in the time allocated for the debate lapse. The same applies to motions for resolutions for which it is established, following a request under Rule 178(3), that a quorum is not present. The authors are entitled to retable such motions either for consideration in committee under Rule 143 or for the debate on cases of breaches of human rights, democracy and the rule of law at the next part-session. A subject may not be included on the agenda for a debate on cases of breaches of human rights, democracy and the rule of law if it is already on the agenda for that part-session. There are no provisions in the Rules to allow a joint debate on a motion for a resolution, tabled in accordance with the second subparagraph of paragraph 2, and a committee report on the same subject. When a request is made under Rule 178(3) to establish whether a quorum is present, that request shall be valid only for the motion for a resolution which is to be put to the vote and not for those which follow. CHAPTER 6 Consultation of other institutions and bodies Rule 145 Consultation of the European Economic and Social Committee 1. Where the Treaty on the Functioning of the European Union provides for the consultation of the Economic and Social Committee, the President shall initiate the consultation procedure and inform Parliament thereof. 2. A committee may request that the European Economic and Social Committee be consulted on matters of a general nature or on specific points. The committee shall indicate, in its request, the deadline for delivery by the European Economic and Social Committee of its opinion. A request for consultation of the European Economic and Social Committee shall be announced to Parliament at its next part-session and shall be deemed to have been approved, unless, within 24 hours from the announcement, a political group or Members reaching at least the low threshold request that it be put to the vote. 3. Opinions forwarded by the Economic and Social Committee shall be referred to the committee responsible. Rule 146 Consultation of the Committee of the Regions 1. Where the Treaty on the Functioning of the European Union provides for the consultation of the Committee of the Regions, the President shall initiate the consultation procedure and inform Parliament thereof. 2. A committee may request that the Committee of the Regions be consulted on matters of a general nature or on specific points. The committee shall indicate, in its request, the deadline for delivery by the Committee of the Regions of its opinion. A request for consultation of the Committee of the Regions shall be announced to Parliament at its next part-session and shall be deemed to have been approved, unless within 24 hours from the announcement a political group or Members reaching at least the low threshold request that it be put to the vote. 3. Opinions forwarded by the Committee of the Regions shall be referred to the committee responsible. Rule 147 Requests to European Agencies 1. Where Parliament has the right to submit a request to a European Agency, any Member may submit that request in writing to the President of Parliament. Such requests shall be on matters that fall within the remit of the Agency concerned and shall be accompanied by background information explaining the issue and the Union interest. 2. The President shall, after consulting the committee responsible, either forward the request to the Agency or take any other appropriate course of action. The Member submitting the request shall be notified immediately. Any request sent by the President to an Agency shall include a time-limit for response. 3. If the Agency considers itself to be unable to respond to the request as formulated, or seeks to have it modified, it shall forthwith inform the President, who shall take any appropriate course of action, after consulting the committee responsible if necessary. CHAPTER 7 Interinstitutional agreements Rule 148 Interinstitutional agreements 1. Parliament may enter into agreements with other institutions in the context of the application of the Treaties, or in order to improve or clarify procedures. Such agreements may take the form of joint declarations, exchanges of letters, codes of conduct or other appropriate instruments. After they have been examined by the committee responsible for constitutional affairs and approved by Parliament, they shall be signed by the President. 2. Where such agreements necessitate changes to existing procedural rights or obligations, establish new procedural rights or obligations for Members or bodies of Parliament, or otherwise necessitate amendment or interpretation of the Rules of Procedure, the matter shall be referred to the committee responsible for the subject matter for its consideration in accordance with Rule 236(2) to (6) before the agreement is signed. CHAPTER 8 Referrals to the Court of Justice of the European Union Rule 149 Proceedings before the Court of Justice of the European Union 1. Parliament shall, within the time limits specified, by the Treaties and the Statute of the Court of Justice of the European Union, for action by the institutions of the Union and by natural or legal persons, examine Union legislation and its implementation in order to ensure that the Treaties have been fully complied with, in particular where Parliament's rights are concerned. 2. If it suspects a breach of Union law, the committee responsible for legal affairs shall report to Parliament, orally if necessary. Where appropriate, the committee responsible for legal affairs may hear the views of the committee responsible for the subject matter. 3. The President shall bring an action on behalf of Parliament in accordance with the recommendation of the committee responsible for legal affairs. At the start of the following part-session, the President may ask Parliament to decide whether the action should be maintained. If Parliament rules against the action by a majority of the votes cast, the President shall withdraw the action. If the President brings an action contrary to the recommendation of the committee responsible for legal affairs, he or she shall, at the start of the following part-session, ask Parliament to decide whether the action should be maintained. 4. The President shall, after consulting the committee responsible for legal affairs, submit observations or intervene in court proceedings on behalf of Parliament. If the President intends to depart from the recommendation of the committee responsible for legal affairs, he or she shall inform the committee accordingly and shall refer the matter to the Conference of Presidents, stating his or her reasons. If the Conference of Presidents takes the view that Parliament should, exceptionally, not submit observations or intervene in a case before the Court of Justice of the European Union in which the legal validity of an act of Parliament is being questioned, the matter shall be submitted to Parliament without delay. Nothing in the Rules prevents the committee responsible for legal affairs from deciding on appropriate procedural arrangements for the timely transmission of its recommendation in urgent cases. Where it is necessary to take a decision as to whether Parliament should exercise its rights vis-\u00e0-vis the Court of Justice of the European Union, and the act in question is not covered by Rule 149 of these Rules of Procedure, the procedure provided for in this rule should apply mutatis mutandis. 5. In urgent cases, the President may, after consulting, where possible, the Chair and the rapporteur of the committee responsible for legal affairs, take precautionary action in order to comply with the relevant time-limits. In such cases, the procedures provided for in paragraphs 3 or 4 shall, as applicable, be implemented at the earliest opportunity. 6. The committee responsible for legal affairs shall lay down the principles that it will use in its application of this Rule. TITLE VI RELATIONS WITH NATIONAL PARLIAMENTS Rule 150 Exchange of information, contacts and reciprocal facilities 1. Parliament shall keep the national parliaments of the Member States regularly informed of its activities. 2. The organisation and promotion of effective and regular interparliamentary cooperation within the Union, pursuant to Article 9 of the Protocol No 1 on the role of national parliaments in the European Union, shall be negotiated on the basis of a mandate given by the Conference of Presidents, after consulting the Conference of Committee Chairs. Parliament shall approve any agreements on such matters in accordance with the procedure set out in Rule 148. 3. A committee may directly engage in dialogue with national parliaments at committee level within the limits of the budgetary appropriations set aside for that purpose. This may include appropriate forms of pre-legislative and post-legislative cooperation. 4. Any document concerning a legislative procedure at Union level that is officially transmitted by a national parliament to the European Parliament shall be forwarded to the committee responsible for the subject-matter dealt with in that document. 5. The Conference of Presidents may give a mandate to the President to negotiate facilities for the national parliaments of the Member States, on a reciprocal basis, and to propose any other measures to facilitate contacts with those national parliaments. Rule 151 Conference of Parliamentary Committees for Union Affairs (COSAC) 1. On a proposal from the President, the Conference of Presidents shall name the members of, and may grant a mandate to, Parliament's delegation to COSAC. The delegation shall be headed by a Vice-President of the European Parliament who is responsible for the implementation of relations with the national parliaments and by the Chair of the committee responsible for constitutional affairs. 2. The other members of the delegation shall be chosen in the light of the subjects to be discussed at the COSAC meeting and shall include, as far as possible, representatives of the committees responsible for those subjects. 3. When choosing members of the delegation, due account shall be taken of the overall political balance within Parliament. 4. The delegation shall, after each COSAC meeting, submit a report to the Conference of Presidents. Rule 152 Conferences of parliaments The Conference of Presidents shall designate the members of Parliament's delegation to any conference or similar body attended by representatives of parliaments and shall grant a mandate to that delegation that conforms to any relevant Parliament resolutions. The delegation shall elect its Chair and, where appropriate, one or more Vice-Chairs. TITLE VII SESSIONS CHAPTER 1 Sessions of Parliament Rule 153 Parliamentary term, sessions, part-sessions, sittings 1. The parliamentary term shall run concurrently with the term of office of Members provided for in the Act of 20 September 1976. 2. The session shall be the annual period prescribed by the Act and the Treaties. 3. The part-session shall be the meeting of Parliament convened as a rule each month and subdivided into daily sittings. Sittings of Parliament held on the same day shall be deemed to be a single sitting. Rule 154 Convening of Parliament 1. In accordance with the first paragraph of Article 229 of the Treaty on the Functioning of the European Union, Parliament shall meet, without requiring to be convened, on the second Tuesday in March each year. It shall itself determine the duration of adjournments of the session. 2. In addition, Parliament shall meet, without requiring to be convened, on the first Tuesday after expiry of an interval of one month from the end of the period referred to in Article 10(1) of the Act of 20 September 1976. 3. The Conference of Presidents, stating its reasons, may alter the duration of the adjournments decided pursuant to paragraph 1 at least two weeks before the date previously fixed by Parliament for resuming the session. The resumption of the session shall not, however, be postponed by more than two weeks. 4. At the request of a majority of its component Members or at the request of the Commission or the Council, the President shall, after consulting the Conference of Presidents, convene Parliament on an exceptional basis. The President shall have the right, with the approval of the Conference of Presidents, to convene Parliament on an exceptional basis in cases of urgency. Rule 155 Venue of sittings and meetings 1. Parliament shall hold its sittings and its committee meetings in accordance with the provisions of the Treaties. Proposals for additional part-sessions in Brussels and any amendments thereto will require only a majority of the votes cast. 2. Any committee may decide to request that one or more meetings be held elsewhere. Such a request, which shall be supported by reasons, shall be made to the President, who shall place it before the Bureau. If the matter is urgent, the President may take the decision himself or herself. If the request is rejected by the Bureau or the President, the reasons for the rejection shall be stated. Rule 156 Attendance of Members at sittings 1. An attendance register shall be open for signature by Members at each sitting. 2. The names of the Members recorded as being present in the attendance register shall be indicated in the minutes of each sitting as \u2018present\u2019. The names of the Members excused by the President shall be indicated in the minutes of each sitting as \u2018excused\u2019. CHAPTER 2 Order of business of Parliament Rule 157 Draft agenda 1. Before each part-session the draft agenda shall be drawn up by the Conference of Presidents on the basis of recommendations by the Conference of Committee Chairs. The Commission and the Council may, at the invitation of the President, attend the deliberations of the Conference of Presidents on the draft agenda. 2. The draft agenda may indicate voting times for certain items down for consideration. 3. The final draft agenda shall be made available to Members at least three hours before the beginning of the part-session. Rule 158 Adopting and amending the agenda 1. At the beginning of each part-session, Parliament shall adopt its agenda. Amendments to the final draft agenda may be proposed by a committee, a political group or Members reaching at least the low threshold. Any such proposals must be received by the President at least one hour before the opening of the part-session. The President may give the floor to the mover and to one speaker against, and in each case for not more than one minute. 2. Once adopted, the agenda may not be amended, except pursuant to Rules 163, 197, 198, 199, 200 or 201, or on a proposal from the President. If a procedural motion to amend the agenda is rejected, it may not be tabled again during the same part-session. The drafting or amendment of the title of a resolution tabled to wind up a debate under Rules 132, 136 or 144 does not constitute a change to the agenda, provided that the title remains within the scope of the subject being debated. 3. Before closing the sitting, the President shall announce the date, time and agenda of the next sitting. Rule 159 Procedure in plenary without amendment and debate 1. Where a report was adopted in committee with fewer than one tenth of the members of the committee voting against, it shall be placed on the draft agenda of Parliament for vote without amendment. The item shall then be subject to a single vote unless, before the drawing up of the final draft agenda, Members or a political group or groups reaching at least the medium threshold have requested in writing that the item be open to amendment, in which case the President shall set a deadline for tabling amendments. 2. Items placed on the final draft agenda for vote without amendment shall also be put to the vote without debate unless Parliament, when adopting its agenda at the start of a part-session, decides otherwise on a proposal from the Conference of Presidents or at the request of a political group or Members reaching at least the low threshold. 3. When drawing up the final draft agenda for a part-session, the Conference of Presidents may propose that other items be put to the vote without amendment or without debate. When adopting its agenda, Parliament may not accept any such proposal if a political group or Members reaching at least the low threshold have tabled their opposition in writing at least one hour before the opening of the part-session. 4. When an item is put to the vote without debate, the rapporteur or the Chair of the committee responsible may, immediately prior to the vote, make a statement, which shall last no more than two minutes. Rule 160 Short presentation At the request of the rapporteur or on a proposal from the Conference of Presidents, Parliament may also decide that an item that does not need a full debate will be dealt with by means of a short presentation in plenary by the rapporteur. In that event, the Commission shall have the opportunity to respond, followed by up to ten minutes of debate in which the President may give the floor, for up to one minute each, to Members who catch his or her eye. Rule 161 Extraordinary debate 1. A political group or Members reaching at least the low threshold may request that an extraordinary debate on a matter of major interest relating to European Union policy be placed on Parliament's agenda. As a rule, no more than one extraordinary debate shall be held during each part-session. 2. The request shall be submitted to the President in writing at least three hours before the start of the part-session at which the extraordinary debate is to take place. The vote on this request shall be taken at the start of the part-session when Parliament adopts its agenda. 3. In response to events that take place after the adoption of the agenda for a part-session, the President, after consulting the Chairs of the political groups, may propose an extraordinary debate. Any such proposal shall be voted on at the start of a sitting or at a scheduled voting time. Members shall be notified of any such proposal for an extraordinary debate at least one hour before the vote. 4. The President shall determine the time at which such a debate is to be held. The overall duration of the debate shall not exceed 60 minutes. Speaking time shall be allocated to the political groups and the non-attached Members in accordance with Rule 171(4) and (5). 5. The debate shall be wound up without the adoption of a resolution. Rule 162 Topical debate requested by a political group 1. At each part-session, one or two periods of at least 60 minutes each shall be set aside in the draft agenda for debates on a topical matter of major interest for European Union policy. 2. Each political group shall have the right to propose a topical matter of its choice for at least one such debate per year. The Conference of Presidents shall ensure, over a rolling period of one year, a fair distribution among the political groups of the exercise of that right. 3. The political groups shall transmit the topical matter of their choice to the President in writing before the drawing up of the final draft agenda by the Conference of Presidents. Rule 39(1) concerning the rights, freedoms and principles recognised by Article 6 of the Treaty on European Union and the values enshrined in its Article 2 shall be fully respected. 4. The Conference of Presidents shall determine the time at which such a debate is to be held. It may, by a majority representing four-fifths of the Parliament Members, decide to reject a matter put forward by a group. 5. The debate shall be introduced by a representative of the political group having proposed the topical matter. Speaking time following this introduction shall be allocated in accordance with Rule 171 (4) and (5). 6. The debate shall be wound up without the adoption of a resolution. Rule 163 Urgent procedure 1. A request to treat a debate on a proposal submitted to Parliament pursuant to Rule 48(1) as urgent may be made to Parliament by the President, a committee, a political group, Members reaching at least the low threshold, the Commission or the Council. Such requests shall be made in writing and supported by reasons. 2. As soon as the President has received a request for urgent debate this shall be announced in Parliament. The vote on the request shall be taken at the beginning of the sitting following that during which the announcement was made, provided that the proposal to which the request relates has been distributed to Members in the official languages. Where there are several requests for urgent debate on the same subject, the approval or rejection of the request for urgent debate shall apply to all such requests that are on the same subject. 3. Before the vote, only the mover, and one speaker against may be heard, along with the Chair or rapporteur of the committee responsible, or both. None of those speakers may speak for more than three minutes. 4. Questions to be dealt with by urgent procedure shall be given priority over other items on the agenda. The President shall determine the time of the debate and vote. 5. An urgent procedure may be held without a report or, exceptionally, on the basis of an oral report by the committee responsible. Where an urgent procedure is used and interinstitutional negotiations take place, Rules 70 and 71 shall not apply. Rule 74 shall apply mutatis mutandis. Rule 164 Joint debate A decision may be taken at any time for similar or factually related items of business to be debated jointly. Rule 165 Time limits Except in the cases of urgency referred to in Rules 144 and 163, a debate and vote shall not be held on a text unless it has been made available to Members at least 24 hours earlier. CHAPTER 3 General rules for the conduct of sittings Rule 166 Access to the Chamber 1. No person may enter the Chamber except Members of Parliament, Members of the Commission or Council, the Secretary-General of Parliament, members of staff whose duties require them to be there, and any person invited by the President. 2. Only holders of an admission card duly issued by the President or Secretary-General of Parliament shall be admitted to the galleries. 3. Members of the public admitted to the galleries shall remain seated and keep silent. Any person expressing approval or disapproval shall immediately be removed by the ushers. Rule 167 Languages 1. All documents of Parliament shall be drawn up in the official languages. 2. All Members shall have the right to speak in Parliament in the official language of their choice. Speeches delivered in one of the official languages shall be simultaneously interpreted into the other official languages and into any other language that the Bureau may consider to be necessary. 3. Interpretation shall be provided in committee and delegation meetings from and into the official languages that are used and requested by the members and substitutes of that committee or delegation. 4. At committee and delegation meetings away from the usual places of work, interpretation shall be provided from and into the languages of those members who have confirmed that they will attend the meeting. These arrangements may exceptionally be made more flexible. The Bureau shall adopt the necessary provisions. 5. After the result of a vote has been announced, the President shall rule on any requests concerning alleged discrepancies between the different language versions. Rule 168 Transitional arrangement 1. During a transitional period expiring at the end of the ninth parliamentary term (30), derogations from Rule 167 shall be permissible if and to the extent that, despite adequate precautions having been taken, interpreters or translators for an official language are not available in sufficient numbers. 2. The Bureau, on a proposal from the Secretary-General and having due regard to the arrangements referred to in paragraph 3, shall ascertain with respect to each of the official languages concerned whether the conditions set out in paragraph 1 are fulfilled. The Bureau shall, on the basis of a progress report from the Secretary-General, review its decision to permit a derogation at six-monthly intervals. The Bureau shall adopt the necessary implementing rules. 3. The temporary special arrangements adopted by the Council on the basis of the Treaties concerning the drafting of legal acts shall apply. 4. Parliament may, on the basis of a reasoned recommendation from the Bureau, decide at any time to repeal this Rule early or, at the end of the period indicated in paragraph 1, to extend it. Rule 169 Distribution of documents The documents that form the basis for Parliament's debates and decisions shall be made available to Members. Without prejudice to the first paragraph, Members and political groups shall have direct access to the European Parliament's internal computer system for the purpose of consulting any non-confidential preparatory document (draft report, draft recommendation, draft opinion, working document, amendments tabled in committee). Rule 170 Electronic handling of documents Parliament documents may be prepared, signed and distributed in electronic form. The Bureau shall decide on the technical specifications, and on the presentation, of the electronic form. Rule 171 Allocation of speaking time and list of speakers (31) 1. The Conference of Presidents may propose to Parliament that speaking time be allocated for a particular debate. Parliament shall decide on this proposal without debate. 2. Members may not speak unless called upon to do so by the President. Members shall speak from their places and shall address the President. If speakers depart from the subject matter of the debate, the President shall call them to order. 3. The President may draw up, for the first part of a particular debate, a list of speakers that includes one or more rounds of speakers from each political group wishing to speak, in the order of the relative size of those political groups. 4. Speaking time for this part of a debate shall be allocated in accordance with the following criteria: (a) a first fraction of speaking time shall be divided equally among all the political groups; (b) a second fraction shall be divided among the political groups in proportion to the total number of their members; (c) the non-attached Members shall be allocated an overall speaking time based on the fractions allocated to each political group under points (a) and (b); (d) the allocation of speaking time in the plenary shall take into consideration the fact that Members with disabilities might need more time. 5. Where a total speaking time is allocated for several items on the agenda, the political groups shall inform the President of the fractions of their speaking time to be used for each individual item. The President shall ensure that these speaking times are respected. 6. The remaining part of the time for a debate shall not be specifically allocated in advance. Instead, the President may call on Members to speak, as a general rule for no more than one minute. The President shall, as far as possible, ensure that speakers who hold different political views and who come from different Member States are heard in turn. 7. On request, the President may give priority to the Chair and to the rapporteur of the committee responsible, as well as to those Chairs of political groups who wish to speak on their groups' behalf, or to speakers who are deputising for them. 8. The President may give the floor to Members who indicate, by raising a blue card, their wish to put to another Member, during that Member's speech, a question of no longer than half a minute's duration related to what that Member has said. The President shall only do so if the speaker agrees to the question and if the President is satisfied that this will lead neither to disruption of the debate nor, through the putting of successive questions by raising a blue card, to a gross imbalance in the political group affinities of Members speaking in that debate. 9. No Member may speak for more than one minute on any of the following subject matters: the minutes of the sitting, procedural motions, or amendments to the final draft agenda or the agenda. 10. In the debate on a report, the Commission and the Council shall, as a rule, be heard immediately after the presentation, by the rapporteur, of his or her report. The Commission, the Council and the rapporteur may be heard again, in particular in order to respond to the statements made by Members. 11. Members who have not spoken in a debate may, no more than once per part-session, hand in a written statement of not more than 200 words, which shall be appended to the verbatim report of the debate. 12. Having due regard to Article 230 of the Treaty on the Functioning of the European Union, the President shall seek to reach an understanding with the Commission, the Council and the President of the European Council on an appropriate allocation to them of speaking time. Rule 172 One-minute speeches For a period of not more than 30 minutes during the first sitting of each part-session, the President shall call Members who wish to draw Parliament's attention to a matter of political importance to speak. Speaking time for each Member shall not exceed one minute. The President may allow a further such period later during the same part-session. Rule 173 Personal statements 1. Members who ask to make a personal statement shall be heard at the end of the discussion of the agenda item which is being dealt with, or when the minutes of the sitting to which the request for leave to speak refers are considered for approval. The Members concerned may not speak on substantive matters but shall confine their observations to rebutting any remarks that have been made concerning their person in the course of the debate or opinions that have been attributed to them, or correcting observations that they themselves have made. 2. Unless Parliament decides otherwise, no personal statement shall last for more than three minutes. Rule 174 Prevention of obstruction (32) The President shall have the power to put an end to the excessive use of motions such as points of order, procedural motions or explanations of vote, or of requests for separate, split or roll-call votes, where he or she is convinced that those motions or requests are manifestly intended to cause, and would result in, a prolonged and serious obstruction of the procedures of Parliament or the rights of the Members. CHAPTER 4 Measures to be taken in the event of non-compliance with the standards of conduct of members Rule 175 Immediate measures 1. The President shall call to order any Member who breaches the standards of conduct defined in Rule 10 (3) or (4). 2. If the breach is repeated, the President shall call the Member to order a second time, and the fact shall be recorded in the minutes. 3. If the breach continues, or if a further breach is committed, the Member may be denied the right to speak and may be excluded from the Chamber by the President for the remainder of the sitting. In cases of exceptional seriousness, the President may also resort to exclusion of the Member concerned from the Chamber for the remainder of the sitting immediately and without a second call to order. The Secretary-General shall, without delay, see to it that such disciplinary measures are carried out, with the assistance of the ushers and, if necessary, of Parliament's Security Service. 4. Should disturbances threaten to obstruct the business of the House, the President shall close or suspend the sitting for a specific period in order to restore order. If the President cannot make himself or herself heard, he or she shall leave the chair; this shall have the effect of suspending the sitting. The President shall reconvene the sitting. 5. The President may decide to interrupt the live broadcasting of the sitting in the case of a breach of Rule 10 (3) or (4) by a Member. 6. The President may order the deletion from the audiovisual record of the proceedings of those parts of a speech by a Member that breach Rule 10 (3) or (4). That order shall take immediate effect. It shall, however, be subject to confirmation by the Bureau not later than four weeks thereafter, or, if the Bureau does not meet during that period, at its next meeting. 7. The powers provided for in paragraphs 1 to 6 shall be vested, mutatis mutandis, in the presiding officers of bodies, committees and delegations as provided for in the Rules of Procedure. 8. Where appropriate, and bearing in mind the seriousness of the breach of the standards of conduct of Members, the Member in the chair of a part-session, body, committee or delegation may, no later than the following part-session or the following meeting of the body, committee or delegation concerned, ask the President to apply Rule 176. Rule 176 Penalties 1. In serious cases of breach of Rule 10 (2) to (9), the President shall adopt a reasoned decision imposing upon the Member concerned the appropriate penalty in accordance with this Rule. In relation to Rule 10 (3) or (4), the President may adopt a reasoned decision under this Rule regardless of whether or not an immediate measure within the meaning of Rule 175 had previously been imposed upon the Member concerned. In relation to Rule 10 (6), the President may only adopt a reasoned decision under this Rule following the establishment of the occurrence of a harassment in accordance with the applicable internal administrative procedure on harassment and its prevention. The President may impose a penalty upon a Member in cases in which provision is made, by these Rules of Procedure or by a decision adopted by the Bureau under Rule 25, for the application of this Rule. 2. The Member concerned shall be invited by the President to submit written observations before the decision is adopted. The President may decide to convene an oral hearing instead whenever it is more appropriate. The decision imposing the penalty shall be notified to the Member concerned by registered letter or, in urgent cases, via the ushers. After that decision has been notified to the Member concerned, any penalty imposed on a Member shall be announced by the President in Parliament. The presiding officers of the bodies, committees and delegations on which the Member serves shall be informed. Once the penalty becomes final, it shall be published prominently on Parliament's website, and shall remain there for the rest of the parliamentary term. 3. When assessing the conduct observed, account shall be taken of its exceptional, recurrent or permanent nature and of its seriousness. Account shall also be taken, if applicable, of possible damage inflicted on the dignity and reputation of Parliament. 4. The penalty may consist of one or more of the following measures: (a) a reprimand; (b) forfeiture of entitlement to the daily subsistence allowance for a period of between two and thirty days; (c) without prejudice to the right to vote in plenary, and subject, in this instance, to strict compliance with the Members' standards of conduct, temporary suspension from participation in all or some of the activities of Parliament for a period of between two and thirty days on which Parliament or any of its bodies, committees or delegations meet; (d) prohibition of the Member from representing the Parliament on an inter-parliamentary delegation, inter-parliamentary conference or any interinstitutional forum, for up to one year; (e) in the case of a breach of confidentiality, a limitation in the rights to access confidential or classified information for up to one year. 5. The measures laid down in points (b) to (e) of paragraph 4 may be doubled in the case of repeated breaches, or if the Member refuses to comply with a measure taken under Rule 175(3). 6. In addition, the President may submit a proposal to the Conference of Presidents for the suspension or removal of the Member from one or more of the offices held by that Member in Parliament, in accordance with the procedure laid down in Rule 21. Rule 177 Internal appeal procedures The Member concerned may lodge an internal appeal with the Bureau within two weeks of notification of the penalty imposed by the President by virtue of Rule 176(1) to (5). Such an appeal shall have the effect of suspending the application of that penalty. The Bureau may, not later than four weeks after the lodging of the appeal or, if it does not meet in that period, at its next meeting, annul, confirm or modify the penalty imposed, without prejudice to the external rights of appeal open to the Member concerned. If the Bureau fails to take a decision within the time limit laid down, the penalty shall be deemed to be null and void. CHAPTER 5 Quorum, amendments and voting Rule 178 Quorum 1. Parliament may deliberate, settle its agenda and approve its minutes, irrespective of the number of Members present. 2. A quorum shall exist when one third of the component Members of Parliament are present in the Chamber. 3. All votes shall be valid whatever the number of Members voting unless the President, on a request made by at least 40 Members before voting began, establishes that a quorum is not present. If the number of Members required to make up a quorum is not present, the President shall declare that a quorum is not present, and the vote shall be placed on the agenda for the next sitting. The electronic voting system may be used in order to check the threshold of 40 Members, but it may not be used for checking the quorum. The doors of the Chamber may not be closed. 4. Members who ask for the quorum to be established must be present in the Chamber when the request is made, and shall be counted as being present within the meaning of paragraphs 2 and 3, even if they then leave the Chamber. 5. If fewer than 40 Members are present, the President may rule that there is no quorum. Rule 179 Thresholds (33) 1. For the purposes of these Rules, and unless specified otherwise, the following definitions shall apply: (a) \u2018low threshold\u2019 means one-twentieth of Parliament's component Members or a political group; (b) \u2018medium threshold\u2019 means one-tenth of Parliament's component Members, made up of one or more political groups or individual Members, or a combination of the two; (c) \u2018high threshold\u2019 means one-fifth of Parliament's component Members made up of one or more political groups or individual Members, or a combination of the two. 2. Where, for the purpose of determining whether an applicable threshold has been reached, a Member's signature is required, that signature may be either handwritten or in electronic form, in which case it shall be produced by the electronic signature system of Parliament. Within the relevant time-limits, a Member may withdraw, but may not subsequently renew, his or her signature. 3. Where the support of a political group is necessary in order for a threshold to be reached, the group shall act through its Chair or through a person duly designated by him or her for that purpose. 4. For the application of the medium and high thresholds, the support of a political group shall be counted as follows: \u2014 where a Rule laying down such a threshold is invoked in the course of a sitting or meeting: all Members who belong to the supporting group and are physically present, \u2014 in all other cases: all Members who belong to the supporting group. Rule 180 Tabling and presenting amendments (34) 1. Amendments for consideration in Parliament may be tabled by the committee responsible, a political group or Members reaching at least the low threshold. The names of all co-signatories shall be published. Amendments shall be tabled in writing and signed by their authors. Amendments to proposals for legally binding acts may be accompanied by a short justification. Such justifications shall be the responsibility of the author and shall not be put to the vote. 2. Subject to the limitations laid down in Rule 181, an amendment may seek to change any part of a text. It may be directed to deleting, adding or replacing words or figures. In this Rule and Rule 181, the term \u2018text\u2019 means the whole of a motion for a resolution/draft legislative resolution, of a proposal for a decision or of a proposal for a legally binding act. 3. The President shall set a deadline for the tabling of amendments. 4. An amendment may be presented during the debate by its author or by any other Member appointed by the author to replace him or her. 5. Where an amendment is withdrawn by its author, it shall fall unless it is immediately taken over by another Member. 6. Amendments shall be put to the vote only after they have been made available in all the official languages, unless Parliament decides otherwise. Parliament may not decide otherwise if at least 40 Members object. Parliament shall avoid taking decisions which would place Members who use a particular language at an unacceptable disadvantage. Where fewer than 100 Members are present, Parliament may not decide otherwise if at least one tenth of the Members present object. On a proposal from the President, an oral amendment, or any other oral modification, shall be treated in the same way as an amendment not made available in all the official languages. If the President considers that it is admissible under Rule 181(2), and save in the case of objection under Rule 180(6), it shall be put to the vote in accordance with the order of voting established. In committee, the number of votes needed to object to such an amendment or such a modification is established on the basis of Rule 219 proportionally to that applicable in plenary, rounded up, where necessary, to the nearest complete number. Rule 181 Admissibility of amendments (35) 1. Without prejudice to the additional conditions laid down in Rule 54(4) concerning own initiative reports and Rule 68(2) concerning amendments to the Council's position, no amendment shall be admissible if: (a) it does not directly relate to the text which it seeks to amend; (b) it seeks to delete or replace the whole of a text; (c) it seeks to amend more than one of the individual articles or paragraphs of the text to which it relates with the exception of compromise amendments and amendments which seek to make identical changes to a particular form of words throughout the text; (d) it seeks to amend a proposal for codification of Union legislation; however, the second subparagraph of Rule 109(3) shall apply mutatis mutandis; (e) it seeks to amend those parts of a proposal recasting Union legislation which remain unchanged in such proposal; however, the second subparagraph of Rule 110(2) and the third subparagraph of Rule 110(3) shall apply mutatis mutandis; (f) it only seeks to ensure the linguistic correctness, or address the terminological consistency, of the text in the language in which the amendment is tabled; in this case, the President shall seek a suitable linguistic remedy together with those concerned. 2. The President shall decide whether amendments are admissible. The President's decision under paragraph 2 concerning the admissibility of amendments is not based exclusively on the provisions of paragraph 1 of this Rule but on the provisions of the Rules in general. 3. A political group or Members reaching at least the low threshold may table an alternative motion for a resolution seeking to replace a motion for a non-legislative resolution contained in a committee report. In such a case, the group or the Members concerned may not table amendments to the motion for a resolution by the committee responsible. The alternative motion for a resolution may not be longer than the committee's motion for a resolution. It shall be put to a single vote in Parliament without amendment. Rule 132(4) and (5) concerning joint motions for resolutions shall apply mutatis mutandis. 4. With the agreement of the President, amendments may, exceptionally, be tabled after the close of the deadline for amendments if they are compromise amendments, or if there are technical problems. The President shall decide on the admissibility of such amendments. The President shall obtain the agreement of Parliament to do so before putting such amendments to the vote. The following general criteria for admissibility of compromise amendments may be applied: \u2014 as a general rule, the compromise amendments relate to parts of the text which have been the subject of amendments prior to the deadline for tabling amendments, \u2014 as a general rule, the compromise amendments are tabled by political groups representing a majority in Parliament, the Chairs or rapporteurs of the committees concerned or the authors of other amendments, \u2014 as a general rule, the compromise amendments entail the withdrawal of other amendments to the same passage. Only the President may propose that a compromise amendment be considered. In order for a compromise amendment to be put to the vote, the President must obtain the agreement of Parliament by asking whether there are any objections to such a vote being held. If an objection is raised, Parliament shall decide on the matter by a majority of the votes cast. Rule 182 Voting procedure (36) 1. Save where these Rules specifically provide otherwise, the following voting procedure shall apply to texts submitted to Parliament: (a) first, where applicable, voting any amendment to the proposal for a legally binding act; (b) second, where applicable, voting on that proposal as a whole, amended or otherwise; If the proposal for a legally binding act, as amended or otherwise, does not secure a majority of the votes cast in committee, then the committee shall propose to Parliament that the proposal be rejected. (c) third, voting on any amendment to the motion for a resolution/draft legislative resolution; (d) finally, voting on the motion for a resolution as a whole (final vote). Parliament shall not vote on any explanatory statement contained in a report. 2. In voting on proposals for legally binding acts and on motions for non-legislative resolutions, votes relating to substantive parts shall be taken first, followed by votes relating to citations and recitals. 3. An amendment shall fall if it is inconsistent with decisions previously taken on the text during the same vote. 4. The only Member permitted to speak during the vote shall be the rapporteur, or, in his or her place, the Chair of the committee. He or she shall have the opportunity of expressing briefly the views of the committee responsible on the amendments put to the vote. Rule 183 Order of voting on amendments (37) 1. Amendments shall have priority over the text to which they relate and shall be put to the vote before that text. 2. If two or more mutually exclusive amendments have been tabled to the same part of a text, the amendment that departs furthest from the original text shall have priority and shall be put to the vote first. If it is adopted, the other amendments shall be deemed to have been rejected; if it is rejected, the amendment next in priority shall be put to the vote, and this procedure shall be repeated for each of the remaining amendments. Where there is a doubt as to priority, the President shall decide. If all amendments are rejected, the original text shall be deemed to have been adopted unless a separate vote has been requested within the deadline specified. 3. However, where the President considers that this will facilitate the vote, he or she may put the original text to the vote first, or put an amendment that is closer to the original text to the vote before the amendment that departs furthest from the original text. If either of these secures a majority, all other amendments tabled to the same part of the text shall fall. 4. Where compromise amendments are put to the vote, they shall be given priority in voting. 5. A split vote shall not be admissible in the case of a vote on a compromise amendment. 6. Where the committee responsible has tabled a set of amendments to the text with which the report is concerned, the President shall put them to the vote collectively, unless on particular points a political group or Members reaching at least the low threshold have requested separate or split votes or unless other competing amendments have been tabled. 7. The President may put other amendments to the vote collectively where they are complementary, unless a political group or Members reaching at least the low threshold have requested separate or split votes. Authors of amendments may also propose collective votes on their amendments. 8. The President may decide, following the adoption or rejection of a particular amendment, that several other amendments of similar content or with similar objectives shall be put to the vote collectively. The President may seek the agreement of Parliament before doing so. Such a set of amendments may relate to different parts of the original text. 9. Where two or more identical amendments are tabled by different authors, they shall be put to the vote as one. 10. Amendments in respect of which a roll-call vote has been requested shall be put to the vote separately from other amendments. Rule 184 Committee filter of plenary amendments When more than 50 amendments or requests for a split or separate vote have been tabled concerning a text tabled by a committee for consideration in Parliament, the President may, after consulting its Chair, ask that committee to meet to vote on each of those amendments or requests. Any amendment or request for a split or separate vote that does not receive votes in favour at this stage from at least one-third of the members of the committee shall not be put to the vote in Parliament. Rule 185 Split voting (38) 1. Where the text to be put to the vote contains two or more provisions or references to two or more points, or lends itself to division into two or more parts that have a distinct meaning and/or normative value, a split vote may be requested by a political group or Members reaching at least the low threshold. 2. The request shall be made at the latest on the evening before the vote, unless the President sets a different deadline. The President shall decide on the request. Rule 186 Right to vote (39) The right to vote is a personal right. Members shall cast their votes individually and in person. Any infringement of this Rule is considered a serious breach of Rule 10(3). Rule 187 Voting (40) 1. As a general rule, Parliament shall vote by show of hands. However, the President may, at any time, decide that the voting operations will be carried out by means of the electronic voting system. 2. The President shall declare votes open and closed. Once the President has declared a vote open, no-one except the President shall be allowed to speak until the vote is declared to be closed. 3. In calculating whether a text has been adopted or rejected, account shall be taken only of votes cast for and against, except in those cases for which the Treaties lay down a specific majority. 4. If the President decides that the result of a vote by show of hands is doubtful, a fresh vote shall be taken using the electronic voting system and, if the latter is not working, by sitting and standing. 5. The President shall establish the result of the vote and announce it. 6. The result of the vote shall be recorded. Rule 188 Final vote When deciding on the basis of a report, Parliament shall take any single and/or final vote by roll call in accordance with Rule 190(3). The provisions of Rule 188 on voting by roll call do not apply to the reports provided for in Rule 8(2) and Rule 9(4), (7) and (9) in the context of procedures relating to the immunity of a Member. Rule 189 Tied votes (41) 1. In the event of a tied vote under Rule 182(1)(b) or (d), the text as a whole shall be referred back to committee. This shall also apply to votes under Rules 3 and 9. 2. In the event of a tied vote on a text put to a split vote under Rule 185, the text shall be deemed to have been adopted. 3. In all other cases where there is a tied vote, without prejudice to those Rules which require qualified majorities, the text or proposal shall be deemed to have been rejected. Rule 189(3) is to be interpreted as meaning that, where there is a tied vote on a draft recommendation under Rule 149(4) not to intervene in proceedings before the Court of Justice of the European Union, such a tie does not signify the adoption of a recommendation according to which Parliament should intervene in those proceedings. In such a case, the committee responsible is to be deemed not to have expressed any recommendation. The President may vote, but shall not have a casting vote. Rule 190 Voting by roll call (42) 1. In addition to the cases provided for in these Rules, the vote shall be taken by roll call if this is requested in writing by a political group or Members reaching at least the low threshold at the latest the evening before the vote unless the President sets a different deadline. The provisions of Rule 190 on voting by roll call do not apply to the reports provided for in Rule 8(2) and Rule 9(4), (7) and (9) in the context of procedures relating to the immunity of a Member. 2. Each political group may table no more than one hundred requests for roll call votes per part-session. 3. The roll call vote shall be taken using the electronic voting system. Where the latter cannot be used for technical reasons, the roll may be called in alphabetical order, beginning with the name of a Member drawn by lot. The President shall be the last to be called to vote. Voting shall be oral and shall be expressed by saying the words \u2018Yes\u2019, \u2018No\u2019, or \u2018I abstain\u2019. 4. Votes shall be recorded in the minutes of the sitting by political group in the alphabetical order of Members' names, with an indication of how they voted. Rule 191 Voting by secret ballot (43) 1. In the case of appointments, voting shall be by secret ballot without prejudice to Rules 15(1) and 213(2), first subparagraph. Only ballot papers bearing the names of candidates who have been nominated shall be taken into account in calculating the number of votes cast. 2. Voting shall also be by secret ballot if this is requested by Members or a political group or groups reaching at least the high threshold. Such requests must be made before voting begins. 3. A request for a secret ballot shall take priority over a request for a vote by roll call. 4. Between two and eight Members chosen by lot shall count the votes cast in a secret ballot, unless an electronic vote is taken. In the case of votes under paragraph 1, candidates shall not act as tellers. The names of Members who have taken part in a secret ballot shall be recorded in the minutes of the sitting at which the ballot was held. Rule 192 Use of electronic voting system (44) 1. The technical arrangements for using the electronic voting system shall be governed by instructions from the Bureau. 2. Where an electronic vote is taken, unless it concerns a roll call vote, only the numerical result of the vote shall be recorded. 3. The President may at any time decide to use the electronic voting system in order to check a threshold. Rule 193 Disputes on voting (45) 1. Points of order concerning the validity of a vote may be raised after the President has declared that vote to be closed. 2. After the result of a vote by show of hands has been announced, a Member may request that that result be checked using the electronic voting system. 3. The President shall decide whether the result announced is valid. His or her decision shall be final. Rule 194 Explanations of votes 1. Once the voting session has been concluded, any Member may give an oral explanation on the single and/or final vote on an item submitted to Parliament for not longer than one minute. Each Member may give a maximum of three oral explanations of vote per part-session. Any Member may, on such vote, hand in a written explanation of vote of no more than 200 words which shall be included on the Member's page on Parliament's website. Any political group may give an explanation of vote lasting not more than two minutes. No further requests to give explanations of votes shall be accepted once the first explanation of vote on the first item has begun. Explanations of votes are admissible on the single and/or final vote on any item submitted to Parliament. For the purposes of this Rule, the term \u2018final vote\u2019 does not refer to the type of vote, but means the last vote on any item. 2. Explanations of votes shall not be admissible in the case of secret ballot or votes on procedural matters. 3. Where an item has been included on the agenda of Parliament without amendments or without debate, Members may only submit written explanations of votes in accordance with paragraph 1. Explanations of votes given either orally or in writing must have a direct bearing on the item submitted to Parliament. CHAPTER 6 Points of order and procedural motions Rule 195 Points of order (46) 1. Members may be allowed to speak in order to draw the attention of the President to any failure to comply with Parliament's Rules of Procedure. They shall first specify to which Rule they are referring. 2. A request to raise a point of order shall take precedence over all other requests to speak or procedural motions. 3. Speaking time shall not exceed one minute. 4. The President shall take an immediate decision on points of order in accordance with the Rules of Procedure and shall announce it immediately after the point of order has been raised. No vote shall be taken concerning the President's decision. 5. Exceptionally, the President may state that he or she will announce the decision later, but the President shall not do so more than 24 hours after the point of order was raised. Postponement of the ruling shall not entail the adjournment of the debate. The President may refer the matter to the committee responsible. A request to raise a point of order must relate to the agenda item under discussion. The President may take a point of order concerning a different matter at an appropriate time, e.g. after the discussion of the agenda item in question is closed or before the sitting is suspended. Rule 196 Procedural motions 1. Requests to move a procedural motion, namely: (a) the inadmissibility of a matter (Rule 197); (b) referral back to committee (Rule 198); (c) the closure of a debate (Rule 199); (d) the adjournment of a debate or vote (Rule 200); or (e) the suspension or closure of the sitting (Rule 201); shall take precedence over other requests to speak. In addition to the mover, only the following Members shall be heard on these motions: one speaker against and the Chair or rapporteur of the committee responsible. 2. The speaking time shall not exceed one minute. Rule 197 Motions calling for a matter to be declared inadmissible 1. At the beginning of the debate on a specific item on the agenda, a political group or Members reaching at least the low threshold may present a motion calling for it to be declared inadmissible. Such a motion shall be put to the vote immediately. The intention to present an inadmissibility motion shall be notified at least 24 hours in advance to the President who shall inform Parliament immediately. 2. If the motion is carried, Parliament shall immediately proceed to the next item on the agenda. Rule 198 Referral back to committee 1. Referral back to committee may be requested by a political group or Members reaching at least the low threshold when the agenda is fixed or before the start of the debate. The intention to present a motion calling for referral back to committee shall be notified at least 24 hours in advance to the President, who shall inform Parliament immediately. 2. A motion calling for referral back to committee may also be presented by a political group or Members reaching at least the low threshold before or during a vote. Such a motion shall be put to the vote immediately. 3. Such a motion may be made only once at each of the procedural stages referred to in paragraphs 1 and 2. 4. Referral back to committee shall entail suspension of the consideration of the item. 5. Parliament may set a time limit for the committee to report its conclusions. Rule 199 Closure of a debate 1. A debate may, on a proposal from the President or at the request of a political group or Members reaching at least the low threshold, be closed before the list of speakers has been exhausted. Such a proposal or request shall be put to the vote immediately. 2. If the proposal or request is carried, one Member only may speak from each political group which has not yet provided a speaker in that debate. 3. After the speeches referred to in paragraph 2, the debate shall be closed and Parliament shall vote on the matter under debate, except where the time for the vote has been set in advance. 4. If the proposal or request is rejected, it may not be tabled again during the same debate, except by the President. Rule 200 Adjournment of a debate or vote (47) 1. At the start of a debate on an item on the agenda, a political group or Members reaching at least the low threshold may move that the debate be adjourned to a specific date and time. Such a motion shall be put to the vote immediately. The intention to move adjournment shall be notified to the President at least 24 hours in advance. The President shall immediately inform Parliament of any notification. 2. If the motion is carried, Parliament shall proceed to the next item on the agenda. The adjourned debate shall be resumed at the specified date and time. 3. If the motion is rejected, it may not be tabled again during the same part-session. 4. Before or during a vote, a political group or Members reaching at least the low threshold may present a motion calling for the vote to be adjourned. Such a motion shall be put to the vote immediately. Rule 201 Suspension or closure of the sitting (48) The sitting may be suspended or closed during a debate or a vote if Parliament so decides on a proposal from the President or at the request of Members or a political group or groups reaching at least the high threshold. Such a proposal or request shall be put to the vote immediately. If a request to suspend or close the sitting is presented, the procedure to vote on that request is to be initiated without undue delay. The usual means of announcing plenary votes should be used and, in accordance with existing practice, sufficient time should be given for Members to reach the Chamber. By analogy with the second subparagraph of Rule 158(2), if such a request has been rejected, a similar request cannot be tabled again during the same day. In accordance with Rule 174, the President has the right to put an end to excessive use of requests presented under this Rule. CHAPTER 7 Public record of proceedings Rule 202 Minutes 1. The minutes of each sitting, detailing the proceedings, the names of speakers and the decisions of Parliament, including the result of any vote on any amendment, shall be made available at least half an hour before the beginning of the afternoon period of the next sitting. 2. A list of documents forming the basis for Parliament's debates and decisions shall be published in the minutes. 3. At the beginning of the afternoon period of each sitting, the President shall place before Parliament, for its approval, the minutes of the previous sitting. 4. If any objections to the minutes are raised, Parliament shall, if necessary, decide whether the changes requested should be taken into account. No Member may speak on the subject for more than one minute. 5. The minutes shall be signed by the President and the Secretary-General and preserved in the records of Parliament. They shall be published in the Official Journal of the European Union. Rule 203 Texts adopted 1. Texts adopted by Parliament shall be published immediately after the vote. They shall be placed before Parliament in conjunction with the minutes of the relevant sitting and preserved in the records of Parliament. 2. Texts adopted by Parliament shall be subject to legal-linguistic finalisation, under the responsibility of the President. Where such texts are adopted on the basis of an agreement reached between Parliament and the Council, such finalisation shall be carried out by those two institutions, acting in close cooperation and by mutual agreement. 3. The procedure laid down in Rule 241 shall apply where, in order to ensure the coherence and quality of the text in accordance with the will expressed by Parliament, adaptations are required which go beyond corrections of typographical errors or corrections necessary to ensure the concordance of all language versions, their linguistic correctness and their terminological consistency. 4. Positions adopted by Parliament under the ordinary legislative procedure shall take the form of a consolidated text. Where the vote in Parliament is not based on an agreement with the Council, the consolidated text shall identify any amendments that were adopted. 5. After finalisation, the texts adopted shall be signed by the President and the Secretary-General and published in the Official Journal of the European Union. Rule 204 Verbatim reports (49) 1. A verbatim report of the proceedings of each sitting shall be drawn up as a multilingual document in which all oral contributions appear in the original official language. 2. Without prejudice to his or her other disciplinary powers, the President may cause to be deleted from the verbatim reports the speeches of Members who have not been called upon to speak or who continue to speak beyond the time allotted to them. 3. Speakers may make corrections to typescripts of their oral contributions within five working days. Corrections shall be sent within that deadline to the Secretariat. 4. The multilingual verbatim report shall be published as an annex to the Official Journal of the European Union and preserved in the records of Parliament. 5. A translation into any official language of an extract from the verbatim report shall be made if it is requested by a Member. If necessary, the translation shall be provided at short notice. Rule 205 Audiovisual record of proceedings 1. The proceedings of Parliament in the languages in which they are conducted, as well as the multilingual soundtrack from all active interpretation booths, shall be broadcast in real time on its website. 2. Immediately after the sitting, an indexed audiovisual record of the proceedings in the languages in which they were conducted, as well as the multilingual soundtrack from all active interpretation booths, shall be produced and made available on Parliament's website for the remainder of the parliamentary term and during the following parliamentary term, after which it shall be preserved in the records of Parliament. That audiovisual record shall be linked to the multilingual verbatim reports of the proceedings as soon as they are available. TITLE VIII COMMITTEES AND DELEGATIONS CHAPTER 1 Committees Rule 206 Setting-up of standing committees Parliament shall, on a proposal from the Conference of Presidents, set up standing committees. Their responsibilities shall be defined in an annex to these Rules of Procedure (50). That annex shall be adopted by a majority of the votes cast. Their members shall be appointed during the first part-session following the re-election of Parliament. The responsibilities of standing committees can also be redefined at a time other than that at which the committee is set up. Rule 207 Special committees 1. On a proposal from the Conference of Presidents, Parliament may, at any time, set up special committees, the responsibilities, numerical strength and term of office of which shall be defined at the same time as the decision to set them up is taken. 2. The term of office of special committees may not exceed 12 months except where Parliament extends that period before its expiry. Unless otherwise decided in Parliament's decision setting up the special committee, its term of office shall start running from the date of its constitutive meeting. 3. Special committees shall not have the right to deliver opinions to other committees. Rule 208 Committees of inquiry 1. In accordance with Article 226 of the Treaty on the Functioning of the European Union and Article 2 of Decision 95/167/EC, Euratom, ECSC of the European Parliament, the Council and the Commission (51), Parliament may, at the request of one quarter of its component Members, set up a committee of inquiry to investigate alleged contraventions or maladministration in implementation of Union law which would appear to be the act of an institution or body of the European Union, of a public administrative body of a Member State, or of persons empowered by Union law to implement that law. The subject of the inquiry, as defined by one quarter of Parliament's component Members, and the period laid down in paragraph 11 shall not be open to amendments. 2. The decision to set up a committee of inquiry shall be published in the Official Journal of the European Union within one month of being taken. 3. The modus operandi of a committee of inquiry shall be governed by the provisions of the Rules relating to committees, save as otherwise specifically provided for in this Rule and in Decision 95/167/EC, Euratom, ECSC. 4. The request to set up a committee of inquiry must precisely specify the subject of the inquiry and include a detailed statement of the grounds for it. Parliament, on a proposal from the Conference of Presidents, shall decide whether to set up a committee and, if so, its numerical strength. 5. Committees of inquiry shall not have the right to deliver opinions to other committees. 6. At any stage of its proceedings, only full members or, in their absence, substitutes may vote in a committee of inquiry. 7. A committee of inquiry shall elect its Chair and Vice-Chairs and appoint one or more rapporteurs. The committee may also assign responsibilities, duties or specific tasks to its members who must subsequently report to the committee in detail thereon. 8. In the interval between one meeting and another, the coordinators of the committee shall, in cases of urgency or need, exercise the committee's powers, subject to ratification by that committee at its next meeting. 9. With regard to the languages used, a committee of inquiry shall apply the provisions of Rule 167. However, the bureau of the committee: \u2014 may restrict interpretation to the official languages of those members of the committee taking part in the deliberations, if it deems this to be necessary for reasons of confidentiality, \u2014 shall decide about the translation of the documents received in such a way as to ensure that the committee can carry out its deliberations efficiently and rapidly, as well as to ensure that the necessary secrecy and confidentiality are respected. 10. Where alleged contraventions or maladministration in the implementation of Union law suggest that a body or authority of a Member State could be responsible, the committee of inquiry may ask the parliament of the Member State concerned to cooperate in the investigation. 11. A committee of inquiry shall conclude its work by presenting to Parliament a report on the results of its work within no more than 12 months from its constitutive meeting. Parliament may twice decide to extend this period by three months. The report may, if appropriate, contain minority positions in accordance with the conditions laid down in Rule 55. The report shall be published. At the request of the committee of inquiry, Parliament shall hold a debate on the report at the part- session following its submission. 12. The committee may also submit to Parliament a draft recommendation addressed to institutions or bodies of the European Union or to the Member States. 13. The President shall instruct the committee responsible under Annex VI to monitor the action taken on the results of the work of the committee of inquiry and, if appropriate, to report thereon. The President shall take any further steps which are deemed to be appropriate in order to ensure that the conclusions of the inquiry are acted upon in practice. Rule 209 Composition of committees 1. Members of committees, special committees and committees of inquiry shall be appointed by the political groups and the non-attached Members. The Conference of Presidents shall set a deadline by which political groups and the non-attached Members are to communicate their appointments to the President, who shall then announce them to Parliament. 2. The composition of the committees shall, as far as possible, reflect the composition of Parliament. The distribution of committee seats among political groups must be either the nearest whole number above or the nearest whole number below the proportional calculation. Where there is no agreement among the political groups on their proportional weight within one or more specific committees, the Conference of Presidents shall decide. 3. If a political group decides not to take seats on a committee, or fails to appoint its members within the deadline set by the Conference of Presidents, the seats in question shall remain vacant. Exchange of seats between political groups is not allowed. 4. Where a Member's change of political group has the effect of disturbing the proportional distribution of committee seats as defined in paragraph 2, and there is no agreement among political groups to ensure compliance with the principles set out therein, the Conference of Presidents shall take the necessary decisions. 5. Any modifications decided to the appointments by political groups and non-attached Members shall be communicated to the President, who shall announce them to Parliament at the latest at the beginning of the next sitting. These decisions shall take effect from the day of the announcement. 6. The political groups and the non-attached Members may appoint a number of substitutes for each committee which shall not exceed the number of full members that the political group or the non-attached Members are entitled to appoint in the committee. The President shall be informed accordingly. These substitutes shall be entitled to attend and to speak at committee meetings and, if the full member is absent, to take part in the vote. 7. In the absence of the full member and where substitutes either have not been appointed or are absent, the full member may arrange to be represented at meetings by another member of the same political group, or, where the member is a non-attached Member, by another non-attached Member, who shall be entitled to vote. The Chair of the committee shall be notified at the latest by the beginning of the voting session. The advance notification provided for in the last sentence of paragraph 7 must be given before the end of the debate or before the opening of the vote on the item or items for which the full member is to be replaced. In accordance with this Rule: \u2014 the status of a full or substitute member of a committee shall depend exclusively on membership of a given political group, \u2014 if the number of a political group's full members in a committee changes, the maximum number of permanent substitutes which it can appoint to that committee shall change accordingly, \u2014 Members who change their political group may not keep the status of full or substitute member of a committee which they had as members of their original group, \u2014 a committee member may not under any circumstances be a substitute for a colleague who belongs to another political group. Rule 210 Duties of committees 1. Standing committees shall examine questions referred to them by Parliament or, during an adjournment of the session, the President on behalf of the Conference of Presidents. 2. Should two or more standing committees be competent to deal with a question, one committee shall be named as the committee responsible and the others as committees asked for opinions. A question shall not, however, be referred simultaneously to more than three committees, unless it is decided to depart from this rule under the conditions laid down in paragraph 1. 3. Any two or more committees or subcommittees may jointly consider matters falling within their competence, but they may not take a decision jointly, except where Rule 58 applies. 4. Any committee may, with the agreement of Parliament's relevant bodies, instruct one or more of its members to undertake a study or fact-finding mission. Rule 211 Questions of competence 1. If a standing committee declares itself not to be competent to consider an item, or if a conflict arises over the competence of two or more standing committees, the question of competence shall be submitted to the Conference of Committee Chairs within four weeks of the announcement in Parliament of the referral to committee. 2. The Conference of Presidents shall take a decision within six weeks after the submission of the question on the basis of a recommendation from the Conference of Committee Chairs, or, if no such recommendation is forthcoming, from the latter's Chair. If the Conference of Presidents fails to take a decision within that period, the recommendation shall be deemed to have been approved. 3. The committee Chairs may enter into agreements with other committee Chairs concerning the allocation of an item to a particular committee, subject, where necessary, to the authorisation of an associated committee procedure under Rule 57. Rule 212 Subcommittees 1. Subcommittees may be set up in accordance with Rule 206. A standing or special committee may also, in the interests of its work and subject to prior authorisation by the Conference of Presidents, appoint one or more subcommittees, at the same time determining their composition, in accordance with the relevant provisions laid down in Rule 209, as well as their areas of responsibility, which must fall within the areas of responsibility of the parent committee. Subcommittees shall report to their parent committee. 2. Unless otherwise specified in these Rules, the procedure for subcommittees shall be the same as for committees. 3. Full members of a subcommittee shall be chosen from among the members of the parent committee. 4. Substitutes shall be allowed to sit on subcommittees under the same conditions as on committees. 5. The Chair of the parent committee may involve the Chairs of the subcommittees in the work of the coordinators or may allow them to chair debates in the parent committee on issues specifically dealt with by the subcommittees in question, provided that this way of proceeding is submitted to the committee bureau for its consideration and approved. Rule 213 Committee bureaux 1. At the first committee meeting after the appointment of committee members pursuant to Rule 209, and again two and a half years thereafter, the committee shall elect a bureau consisting of a Chair and of Vice-Chairs from among its full members in separate ballots. The number of Vice-Chairs to be elected shall be determined by Parliament upon a proposal by the Conference of Presidents. The diversity of Parliament must be reflected in the composition of the bureau of each committee; it shall not be permissible to have an all male or all female bureau or for all of the Vice-Chairs to come from the same Member State. 2. Where the number of nominations corresponds to the number of seats to be filled, the election shall take place by acclamation. However, if there is more than one candidate on a given ballot, or members or a political group or groups reaching at least the high threshold in the committee requested a vote, the election shall take place by secret ballot. If there is only one candidate, the election shall be by an absolute majority of the votes cast, for and against. If there is more than one candidate, the candidate who obtains an absolute majority of the votes cast at the first ballot shall be elected. At the second ballot, the candidate who obtains the highest number of votes shall be elected. In the event of a tie, the oldest candidate shall be elected. 3. The following Rules concerning the Officers of Parliament shall apply mutatis mutandis to committees: Rule 14 (Provisional Chair), Rule 15 (Nominations and general provisions), Rule 16 (Election of President \u2014 opening address), Rule 19 (Term of office of Officers) and Rule 20 (Vacancies). Rule 214 Committee coordinators 1. The political groups may designate one of their members in each committee to be a coordinator. 2. A meeting of the committee coordinators shall if necessary be convened by the committee Chair to prepare decisions to be taken by the committee, in particular decisions on procedure and on the appointment of rapporteurs. The committee may delegate the power to take certain decisions to the coordinators, with the exception of decisions concerning the adoption of reports, motions for resolutions, opinions or amendments. The Vice-Chairs may be invited to participate in the meetings of committee coordinators in a consultative role. When consensus cannot be attained, the coordinators may only act by a majority that clearly represents a large majority of the committee, having regard to the respective strengths of the various political groups. The Chair shall announce in committee all decisions and recommendations of the coordinators, which shall be deemed to have been adopted if they have not been contested. They shall be duly mentioned in the minutes of the committee meeting. Non-attached Members do not constitute a political group within the meaning of Rule 33 and they cannot therefore designate coordinators, who are the only Members entitled to attend coordinator meetings. In all cases, non-attached Members must be guaranteed access to information, in accordance with the principle of non-discrimination, through the supply of information and the presence of a member of the non-attached Members' secretariat at coordinator meetings. Rule 215 Shadow Rapporteurs The political groups may designate a shadow rapporteur for each report to follow the progress of the relevant report and find compromises within the committee on behalf of the group. Their names shall be communicated to the committee Chair. Rule 216 Committee meetings 1. A committee shall meet when convened by its Chair or at the request of the President. When convening the meeting, the Chair shall submit a draft agenda. The committee shall take a decision on the agenda at the beginning of the meeting. 2. The Commission, the Council and other Union institutions may take the floor in committee meetings if invited to do so on behalf of a committee by its Chair. By decision of a committee, any other person may be invited to attend and to take the floor at a meeting. The committee responsible may, subject to approval by the Bureau, organise a hearing of experts if it considers such a hearing to be essential for the effective conduct of its work on a particular subject. 3. Without prejudice to Rule 56(8) and unless the committee concerned decides otherwise, Members who attend meetings of committees to which they do not belong, may not take part in their deliberations. They may, however, be allowed by the committee to take part in its meetings in an advisory capacity. 4. Rule 171(2) on allocation of speaking time shall apply mutatis mutandis to committees. 5. Where a verbatim report is drawn up, Rule 204 (2), (3) and (5) shall apply mutatis mutandis. Rule 217 Minutes of committee meetings The minutes of each meeting of a committee shall be made available to all its members and submitted to the committee for its approval. Rule 218 Voting in committee 1. Without prejudice to Rule 65(3) on second readings, amendments or draft proposals for rejection tabled for consideration in committee shall always be signed by a full or substitute member of the committee concerned or co-signed by at least one such member. 2. A committee may validly vote when one quarter of its members are actually present. However, if so requested by members or a political group or groups reaching at least the high threshold in the committee before voting begins, the vote shall be valid only if the majority of its members have taken part in it. 3. Any single and/or final vote in committee on a report or opinion shall be taken by roll call in accordance with Rule 190(3) and (4). The vote on amendments and other votes shall be taken by a show of hands, unless the Chair decides to proceed to an electronic vote or members or a political group or groups reaching at least the high threshold in the committee request a vote by roll call. The provisions of Rule 218(3) on voting by roll call do not apply to the reports provided for in Rule 8(2) and Rule 9(4), (7) and (9) in the context of procedures relating to the immunity of a Member. 4. In the light of the amendments tabled, the committee may, instead of proceeding to a vote, ask the rapporteur to submit a new draft taking account of as many of the amendments as possible. A new deadline shall then be set for amendments. Rule 219 Provisions concerning plenary sittings applicable in committee The following Rules concerning voting, points of order and procedural motions shall apply mutatis mutandis to committees: Rule 174 (Prevention of obstruction), Rule 179 (Thresholds), Rule 180 (Tabling and presenting amendments), Rule 181 (Admissibility of amendments), Rule 182 (Voting procedure), Rule 183 (Order of voting on amendments), Rule 185(1) (Split voting), Rule 186 (Right to vote), Rule 187 (Voting), Rule 189 (Tied votes), Rule 190(3) and (4) (Voting by roll call), Rule 191 (Voting by secret ballot), Rule 192 (Use of electronic voting system), Rule 193 (Disputes on voting), Rule 195 (Points of order), Rule 200 (Adjournment of a debate or vote) and Rule 201 (Suspension or closure of the sitting). Rule 220 Question Time in committee Question Time may be held in committee if a committee so decides. Each committee shall decide on its own rules for the conduct of Question Time. Rule 221 Procedure for the consultation by a committee of confidential information in a committee meeting in camera 1. When Parliament is under a legal obligation to treat information received as confidential information, the Chair of the committee responsible shall automatically apply the confidential procedure laid down in paragraph 3. 2. Without prejudice to paragraph 1, in the absence of any legal obligation to treat the information received as confidential information, any committee may apply the confidential procedure laid down in paragraph 3 on its own motion to an item of information or a document indicated by one of its members in a written or oral request. A majority of two-thirds of the members present shall be required for the adoption of a decision to apply the confidential procedure in such a case. 3. Once the Chair of the committee has declared that the confidential procedure is to be applied, the meeting shall be in camera and may be attended only by members of the committee, including substitute members. The committee may decide, in compliance with the applicable inter-institutional legal framework, that other Members may attend the meeting pursuant to Rule 216(3). The meeting may also be attended by those persons who have been designated in advance by the Chair, as having a need-to-know, in due respect of any restrictions stemming from the applicable rules governing the treatment of confidential information by Parliament. As regards the consultation of classified information at the level of CONFIDENTIEL UE/EU CONFIDENTIAL and above, or in case of specific limitations of access stemming from the interinstitutional legal framework, additional restrictions may apply. The documents shall be distributed at the beginning of the meeting and collected again at the end. They shall be numbered. No notes and no photocopies may be taken. The minutes of the meeting shall make no mention of the discussion of the item dealt with under the confidential procedure. Only the relevant decision, if any, may be recorded. 4. Without prejudice to the applicable rules on breach of confidentiality in general, Members or a political group or groups reaching at least the medium threshold in the committee which has applied the confidential procedure may request consideration of a breach of confidentiality. This request may be placed on the agenda of the next committee meeting. By a majority of its members, the committee may decide to submit the matter to the President for further consideration under Rules 10 and 176. This Rule applies to the extent that the applicable legal framework relating to the treatment of confidential information provides for the possibility of consulting the confidential information at a meeting in camera outside the secure facilities. Rule 222 Public hearings and debates on citizens' initiatives 1. When the Commission has published a citizens' initiative in the relevant register pursuant to point (a) of Article 10(1) of Regulation (EU) No 211/2011 of the European Parliament and of the Council (52), the President of the European Parliament, on a proposal from the Chair of the Conference of Committee Chairs: (a) shall task the committee responsible for the subject-matter according to Annex VI with organising the public hearing provided for in Article 11 of Regulation (EU) No 211/2011; the committee responsible for petitions shall be automatically associated under Rule 57; (b) may, where two or more citizens' initiatives published in the relevant register pursuant to point (a) of Article 10(1) of Regulation (EU) No 211/2011 have a similar subject-matter, decide, after consulting the organisers, that a joint public hearing is to be organised at which all of the citizens' initiatives involved shall be dealt with on an equal footing. 2. The committee responsible for the subject-matter: (a) shall ascertain whether the Commission has received the organisers at an appropriate level in accordance with point (b) of Article 10(1) of Regulation (EU) No 211/2011; (b) shall ensure, if necessary with the support of the Conference of Committee Chairs, that the Commission is properly involved in organising the public hearing and that it is represented at an appropriate level at the hearing. 3. The Chair of the committee responsible for the subject-matter shall convene the public hearing at an appropriate date within three months of the submission of the initiative to the Commission pursuant to Article 9 of Regulation (EU) No 211/2011. 4. The committee responsible for the subject matter shall organise the public hearing at Parliament, if appropriate together with such other institutions and bodies of the Union that wish to participate. It may invite other stakeholders to attend. The committee responsible for the subject matter shall invite a representative group of organisers, including at least one of the contact persons referred to in the second subparagraph of Article 3(2) of Regulation (EU) No 211/2011, to present the initiative at the hearing. 5. The Bureau shall, in accordance with the arrangements agreed with the Commission, adopt rules concerning the reimbursement of incurred costs. 6. The President of Parliament and the Chair of the Conference of Committee Chairs may delegate their powers under this Rule to a Vice-President and another committee Chair respectively. 7. If the conditions laid down in Rule 57 or Rule 58 are met, those provisions shall also apply, mutatis mutandis, to other committees. Rules 210 and 211 shall also apply. Rule 25(9) shall not apply to public hearings on citizens' initiatives. 8. Parliament shall hold a debate on a citizens' initiative published in the relevant register pursuant to point (a) of Article 10(1) of Regulation (EU) No 211/2011, at a part-session following the public hearing and shall, when placing the debate on its agenda, decide whether or not to wind up the debate with a resolution. It shall not wind up the debate with a resolution if a report on an identical or similar subject matter is scheduled for the same or the next part-session, unless the President, for exceptional reasons, proposes otherwise. If Parliament decides to wind up a debate with a resolution, the committee responsible for the subject matter or a political group or Members reaching at least the low threshold may table a motion for a resolution. Rule 132(3) to (8) concerning the tabling and voting of motions for resolutions shall apply mutatis mutandis. 9. Following the Commission's communication setting out its legal and political conclusions on a specific citizens' initiative, Parliament shall assess the actions taken by the Commission as a result of such communication. In the event that the Commission fails to submit an appropriate proposal on a citizens' initiative, the committee responsible for the subject matter may organise a hearing in consultation with the citizens' initiative organisers. Furthermore, Parliament may decide whether to hold a plenary debate and whether to wind up this debate with a resolution. The procedure set out in paragraph 8 shall apply mutatis mutandis. Parliament may also decide to exercise the right conferred on it by Article 225 of the Treaty on the Functioning of the European Union, thereby activating the procedure laid down in Rule 47. CHAPTER 2 Interparliamentary delegations Rule 223 Setting-up and duties of interparliamentary delegations 1. On a proposal from the Conference of Presidents, Parliament shall set up standing interparliamentary delegations and decide on their nature and the number of their members in the light of their duties. The members shall be appointed by the political groups and the non-attached Members during the first or second part-session following the re-election of Parliament for the duration of the parliamentary term. 2. The political groups shall ensure as far as possible that Member States, political views and gender are fairly represented. It shall not be permissible for more than one third of the members of a delegation to have the same nationality. Rule 209 shall apply mutatis mutandis. 3. The bureaux of the delegations shall be constituted in accordance with the procedure laid down for the standing committees in Rule 213. 4. Parliament shall determine the general powers of the individual delegations. It may at any time decide to increase or restrict those powers. 5. The implementing provisions needed to enable the delegations to carry out their work shall be adopted by the Conference of Presidents on a proposal from the Conference of Delegation Chairs. 6. The Chair of a delegation shall regularly report back to the committee responsible for foreign affairs on the activities of the delegation. 7. The Chair of a delegation shall be given an opportunity to be heard by a committee when an item on the agenda touches on the delegation's area of responsibility. The same shall apply to the Chair or rapporteur of that committee in the case of meetings of the delegation. Rule 224 Joint parliamentary committees 1. The European Parliament may set up joint parliamentary committees with the parliaments of States associated with the Union or States with which the Union has commenced accession negotiations. Such committees may formulate recommendations for the parliaments involved. In the case of the European Parliament, these recommendations shall be referred to the committee responsible, which shall put forward proposals on the action to be taken. 2. The general responsibilities of the various joint parliamentary committees shall be defined by the European Parliament, in accordance with the agreements with the third countries. 3. Joint parliamentary committees shall be governed by the procedures laid down in the relevant agreement. Such procedures shall be based on the principle of parity between the delegation of the European Parliament and that of the parliament involved. 4. Joint parliamentary committees shall draw up their own rules of procedure and submit them for approval, within the European Parliament to its Bureau, and within the third country parliament involved to the latter's relevant body. 5. The appointment of the members of the European Parliament's delegations to joint parliamentary committees and the constitution of the bureaux of these delegations shall take place in accordance with the procedure laid down for interparliamentary delegations. Rule 225 Cooperation with the Parliamentary Assembly of the Council of Europe 1. Parliament's bodies, and in particular its committees, shall cooperate with their counterparts at the Parliamentary Assembly of the Council of Europe in fields of mutual interest, with the aim in particular of improving the efficiency of their work and avoiding duplication of effort. 2. The Conference of Presidents, in agreement with the competent authorities of the Parliamentary Assembly of the Council of Europe, shall decide on the arrangements for that cooperation. TITLE IX PETITIONS Rule 226 Right of petition 1. In accordance with Article 227 of the Treaty on the Functioning of the European Union, any citizen of the European Union and any natural or legal person residing or having its registered office in a Member State shall have the right to address, individually or in association with other citizens or persons, a petition to Parliament on a matter which comes within the European Union's fields of activity and which affects him, her or it directly. 2. Petitions to Parliament shall show the name and the permanent address of each petitioner. 3. Submissions to Parliament that are clearly not intended to be a petition shall not be registered as petitions; instead, they shall be forwarded without delay to the appropriate service for further treatment. 4. Where a petition is signed by several natural or legal persons, the signatories shall designate a representative and deputy representatives who shall be regarded as the petitioners for the purposes of this Title. If no such representatives have been designated the first signatory or another appropriate person shall be regarded as the petitioner. 5. Each petitioner may at any time withdraw his, her or its signature from the petition. If all petitioners withdraw their signatures, the petition shall become null and void. 6. Petitions must be written in an official language of the European Union. Petitions written in any other language will be considered only if the petitioner has attached a translation in an official language. Parliament's correspondence with the petitioner shall employ the official language in which the translation is drawn up. The Bureau may decide that petitions and correspondence with petitioners may be drafted in other languages which, in accordance with the constitutional order of the Member States concerned, enjoy official status in all or part of their territory. 7. Petitions can be submitted either by post or through the Petitions portal, which shall be made available on Parliament's website and which shall guide the petitioner to formulate the petition in a manner that complies with paragraphs 1 and 2. 8. Where several petitions are received on a similar subject matter, they may be dealt with jointly. 9. Petitions shall be entered in a register in the order in which they are received if they comply with the conditions laid down in paragraph 2. Petitions that do not comply with those conditions shall be filed, and the petitioner shall be informed of the reasons for this. 10. Petitions entered in the register shall be forwarded by the President to the committee responsible for petitions, which shall first establish the admissibility of the petition in accordance with Article 227 of the Treaty on the Functioning of the European Union. If the committee fails to reach a consensus on the admissibility of the petition, it shall, at the request of at least one-third of the members of the committee, be declared admissible. 11. Petitions that have been declared inadmissible by the committee shall be filed. The petitioner shall be informed of the decision and the reasons for it. Where possible, alternative means of redress may be recommended. 12. Petitions, once registered, shall become public documents, and the name of the petitioner, possible co-petitioners and possible supporters and the contents of the petition may be published by Parliament for reasons of transparency. The petitioner, co-petitioners and supporters shall be informed accordingly. 13. Notwithstanding paragraph 12, the petitioner, a co-petitioner or a supporter may request that his, her or its name be withheld in order to protect his, her or its privacy, in which case Parliament shall comply with the request. Where the petitioner's complaint cannot be investigated because of the petitioner's anonymity, the petitioner shall be consulted on the further steps to be taken. 14. In order to protect the rights of third parties, Parliament may, on its own motion or at the request of the third party concerned, anonymise a petition and/or other data contained therein, if it sees fit to do so. 15. Petitions addressed to Parliament by natural or legal persons who are neither citizens of the European Union nor reside in a Member State nor have their registered office in a Member State shall be registered and filed separately. The President shall send a monthly record of such petitions received during the previous month, indicating their subject-matter, to the committee. The committee may ask to see those which it wishes to consider. Rule 227 Examination of petitions 1. Admissible petitions shall be considered by the committee responsible for petitions in the course of its normal activity, either through discussion at a regular meeting or by written procedure. Petitioners may be invited to participate in meetings of the committee if their petition is to be the subject of discussion, or they may ask to be present. The right to speak shall be granted to petitioners at the discretion of the Chair. 2. With regard to an admissible petition, the committee may decide to submit a short motion for a resolution to Parliament, provided that the Conference of Committee Chairs is informed in advance and there is no objection by the Conference of Presidents. Such motions for resolutions shall be placed on the draft agenda of the part-session to be held no later than eight weeks after the adoption of those motions for resolutions in the committee. They shall be put to a single vote. The Conference of Presidents may propose to apply Rule 160, failing which those motions for resolutions shall be put to the vote without debate. 3. Where, with regard to an admissible petition, the committee intends to draw up under Rule 54(1) an own initiative report dealing with, in particular, the application or interpretation of Union law or proposed changes to existing law, the committee responsible for the subject-matter shall be associated in accordance with Rule 56 and Rule 57. The committee shall without a vote accept suggestions for parts of the motion for a resolution received from the committee responsible for the subject-matter where those suggestions deal with the application or interpretation of Union law or changes to existing law. If the committee does not accept such suggestions, the committee responsible for the subject matter may table them directly in plenary. 4. Signatories may lend support to, or withdraw support from, an admissible petition on the Petitions Portal. That portal shall be made available on Parliament's website. 5. The committee may request assistance from the Commission particularly in the form of information on the application of, or compliance with, Union law and information or documents relevant to the petition. Representatives of the Commission shall be invited to attend meetings of the committee. 6. The committee may ask the President to forward its opinion or recommendation to the Commission, the Council or the Member State authority concerned for its action or response. 7. The committee shall report to Parliament annually on the outcome of its deliberations and, where appropriate, on the measures taken by the Council or the Commission on petitions referred to them by Parliament. When consideration of an admissible petition has been concluded, it shall be declared closed by a decision of the committee. 8. The petitioner shall be informed of all relevant decisions taken by the committee and the reasons thereof. 9. A petition may be re-opened by committee decision, if relevant new facts relating to the petition have been brought to its attention and the petitioner so requests. 10. By a majority of its members, the committee shall adopt guidelines for the treatment of petitions in accordance with these Rules of Procedure. Rule 228 Fact-finding visits 1. When investigating petitions, establishing facts or seeking solutions the committee may organise fact-finding visits to the Member State or region that are concerned by admissible petitions that have been already debated in the committee. As a general rule, fact-finding visits shall cover issues raised in several petitions. The Bureau Rules governing committee delegations within the European Union shall apply. 2. Members elected in the Member State of destination shall not be part of the delegation. They may be allowed to accompany the fact-finding visit delegation in an ex officio capacity. 3. After each visit, a mission report shall be drafted by the official members of the delegation. The Head of the delegation shall coordinate the drafting of the report and shall seek consensus on its content among the official members on an equal footing. Failing such a consensus, the mission report shall set out the divergent assessments. Members taking part in the delegation ex officio shall not participate in the drafting of the report. 4. The mission report, including possible recommendations, shall be submitted to the committee. Members may table amendments to the recommendations, but not to the parts of the report concerning the facts established by the delegation. The committee shall first vote on the amendments to the recommendations, if any, then on the mission report as a whole. The mission report, if approved, shall be forwarded to the President, for information. Rule 229 Notice of petitions 1. Notice shall be given in Parliament of the petitions entered in the register referred to in Rule 226(9) and the main decisions on the procedure to be followed in relation to specific petitions. Such announcements shall be entered in the minutes of proceedings. 2. The title and a summary of the texts of petitions entered in the register, together with the texts of the opinions and the most important decisions forwarded in connection with the examination of the petitions, shall be made available to the public on the Petitions Portal on Parliament's website. Rule 230 Citizens' initiative 1. When Parliament is informed that the Commission has been invited to submit a proposal for a legal act under Article 11(4) of the Treaty on European Union and in accordance with Regulation (EU) No 211/2011, the committee responsible for petitions shall ascertain whether this is likely to affect its work and, if need be, shall inform those petitioners who have addressed petitions on related subjects. 2. Proposed citizens' initiatives which have been registered in accordance with Article 4 of Regulation (EU) No 211/2011, but which cannot be submitted to the Commission in accordance with Article 9 of that Regulation since not all the relevant procedures and conditions laid down have been complied with, may be examined by the committee responsible for petitions if it considers that follow-up is appropriate. Rules 226, 227, 228 and 229 shall apply mutatis mutandis. TITLE X OMBUDSMAN Rule 231 Election of the Ombudsman 1. At the start of each parliamentary term or in the case of death, resignation or dismissal of the Ombudsman, the President shall call for nominations for the office of Ombudsman and set a time limit for their submission. A notice calling for nominations shall be published in the Official Journal of the European Union. 2. Nominations must have the support of at least 40 Members who are nationals of at least two Member States. Each Member may support only one nomination. Nominations shall include all the supporting documents needed to show conclusively that the nominee fulfils the conditions laid down in Article 6(2) of Decision 94/262/ECSC, EC, Euratom of the European Parliament (53). 3. Nominations shall be forwarded to the committee responsible. A full list of the Members who have given their support to the nominees shall be made available to the public in due time. 4. The committee responsible may ask to hear the nominees. Such hearings shall be open to all Members. 5. A list of admissible nominations in alphabetical order shall then be submitted to the vote of Parliament. 6. The Ombudsman shall be elected by a majority of the votes cast. If no candidate is elected after the first two ballots, only the two candidates obtaining the largest number of votes in the second ballot may continue to stand. In the event of any tie the oldest candidate shall be appointed. 7. Before opening the vote, the President shall ensure that at least half of Parliament's component Members are present. 8. The Ombudsman shall exercise his or her duties until his or her successor takes office, except in the case of his or her death or dismissal. Rule 232 Activities of the Ombudsman 1. The committee responsible shall examine cases of maladministration that it has been informed of by the Ombudsman pursuant to Article 3(6) and (7) of Decision 94/262/ECSC, EC, Euratom, following which it may decide to draw up a report under Rule 54. The committee responsible shall examine the report submitted by the Ombudsman at the end of each annual session on the outcome of his or her inquiries, in accordance with Article 3(8) of Decision 94/262/ECSC, EC, Euratom. The committee responsible may submit a motion for resolution to Parliament if it considers that Parliament needs to take a position in respect of any aspect of that report. 2. The Ombudsman may also provide the committee responsible with information at its request, or be heard by it on his or her own initiative. Rule 233 Dismissal of the Ombudsman 1. One tenth of Parliament's component Members may request the dismissal of the Ombudsman if he or she no longer fulfils the conditions required for the performance of his or her duties or is guilty of serious misconduct. Where such a request for dismissal has been voted on in the preceding two months, a new one may only be tabled by one fifth of the component Members of Parliament. 2. The request shall be forwarded to the Ombudsman and to the committee responsible, which, if it decides by a majority of its members that the reasons are well founded, shall submit a report to Parliament. If he or she so requests, the Ombudsman shall be heard before the report is put to the vote. Parliament shall, following a debate, take a decision by secret ballot. 3. Before taking the vote, the President shall ensure that at least half of Parliament's component Members are present. 4. If the vote is in favour of the Ombudsman's dismissal and he or she does not resign, the President shall, at the latest by the part-session following that at which the vote was held, apply to the Court of Justice to have the Ombudsman dismissed and request that a ruling be given without delay. Resignation by the Ombudsman shall terminate the procedure. TITLE XI PARLIAMENT'S SECRETARIAT Rule 234 Parliament's Secretariat 1. Parliament shall be assisted by a Secretary-General appointed by the Bureau. The Secretary-General shall give a solemn undertaking before the Bureau to perform his or her duties conscientiously and with absolute impartiality. 2. The Secretary-General shall head a Secretariat the composition and organisation of which shall be determined by the Bureau. 3. The Bureau shall decide on the establishment plan of Parliament's Secretariat and lay down regulations relating to the administrative and financial situation of officials and other servants. The President of Parliament shall inform the appropriate institutions of the European Union accordingly. TITLE XII POWERS AND RESPONSIBILITIES RELATING TO EUROPEAN POLITICAL PARTIES AND EUROPEAN POLITICAL FOUNDATIONS Rule 235 Powers and responsibilities relating to European political parties and European political foundations (54) 1. Where, in accordance with Article 65(1) of the Financial Regulation, Parliament decides to reserve to itself the right to authorise expenditure, it shall act through its Bureau. On this basis, the Bureau shall be competent to adopt decisions under Articles 17, 18, 24, 27(3) and 30 of Regulation (EU, Euratom) No 1141/2014 of the European Parliament and of the Council (55). Individual decisions adopted by the Bureau on the basis of this paragraph shall be signed by the President on its behalf and shall be notified to the applicant or to the beneficiary in accordance with Article 297 of the Treaty on the Functioning of the European Union. Individual decisions shall state the reasons on which they are based in accordance with the second paragraph of Article 296 of that Treaty. The Bureau may at any time consult the Conference of Presidents. 2. At the request of one quarter of the component Members of Parliament representing at least three political groups, Parliament shall vote on the decision to request, in accordance with Article 10(3) of Regulation (EU, Euratom) No 1141/2014, the Authority for European Political Parties and European Political Foundations to verify whether a registered European political party or a registered European political foundation complies with the conditions laid down in point (c) of Article 3(1) and point (c) of Article 3(2) of Regulation (EU, Euratom) No 1141/2014. 3. On the basis of the first subparagraph of Article 10(3) of Regulation (EU, Euratom) No 1141/2014, a group of at least 50 citizens may submit a reasoned request inviting Parliament to request the verification mentioned in paragraph 2. That reasoned request shall not be launched or signed by Members. It shall include substantial factual evidence showing that the European political party or European political foundation in question does not comply with the conditions referred to in paragraph 2. The President shall forward admissible requests from groups of citizens to the committee responsible for further examination. Following that examination, which should take place within four months from the President's referral, the committee responsible may, by a majority of its component members representing at least three political groups, submit a proposal to follow up the request and inform the President thereof. The group of citizens shall be informed of the outcome of the committee's examination. Upon reception of the committee proposal, the President shall communicate the request to Parliament. Following such a communication, Parliament shall, by a majority of the votes cast, decide on whether or not to lodge a request to the Authority for European Political Parties and European Political Foundations. The committee shall adopt guidelines for the treatment of such requests from groups of citizens. 4. At the request of one quarter of the component Members of Parliament representing at least three political groups, Parliament shall vote on a proposal for a reasoned decision to object, pursuant to Article 10(4) of Regulation (EU, Euratom) No 1141/2014, to the decision of the Authority for European Political Parties and European Political Foundations to deregister a European political party or a European political foundation within three months of the communication of the decision. The committee responsible shall submit a proposal for a reasoned decision. If this proposal is rejected, the contrary decision shall be deemed to have been adopted. 5. On the basis of a proposal by the committee responsible, the Conference of Presidents shall appoint two members of the committee of independent eminent persons pursuant to Article 11(1) of Regulation (EU, Euratom) No 1141/2014. TITLE XIII APPLICATION AND AMENDMENT OF THE RULES OF PROCEDURE Rule 236 Application of the Rules of Procedure 1. If doubt arises over the application or interpretation of these Rules of Procedure, the President may refer the matter to the committee responsible for examination. Committee Chairs may do so when such a doubt arises in the course of the committee's work and is related to it. 2. The committee shall decide whether it is necessary to propose an amendment to the Rules of Procedure. If this should be the case, it shall proceed in accordance with Rule 237. 3. If the committee decides that an interpretation of the existing Rules is sufficient, it shall forward its interpretation to the President, who shall inform Parliament thereof at its next part-session. 4. If a political group or Members reaching at least the low threshold contest the committee's interpretation within a period of 24 hours following its announcement, the matter shall be put to the vote in Parliament. Adoption of the text shall be by a majority of the votes cast, provided that at least one third of Parliament's component Members are present. In the event of rejection, the matter shall be referred back to the committee. 5. Uncontested interpretations and interpretations adopted by Parliament shall be appended in italic print as explanatory notes to the appropriate Rule or Rules. 6. Interpretations shall constitute precedents for the future application and interpretation of the Rules concerned. 7. The Rules of Procedure and interpretations shall be reviewed regularly by the committee responsible. 8. Where these Rules confer rights on a specific number of Members, that number shall be automatically adjusted to the nearest whole number representing the same percentage of Parliament's membership whenever the total size of Parliament is modified, in particular following enlargements of the European Union. Rule 237 Amendment of the Rules of Procedure 1. Any Member may propose amendments to these Rules and to their annexes accompanied, where appropriate, by short justifications. The committee responsible shall examine them and decide whether to submit them to Parliament. For the purpose of applying Rules 180, 181 and 183 to consideration of such proposed amendments in Parliament, references made in those Rules to the \u2018original text\u2019 or the proposal for a legally binding act shall be considered as referring to the provision in force at the time. 2. In accordance with Article 232 of the Treaty on the Functioning of the European Union, amendments to these Rules shall be adopted only if they secure the votes of a majority of the component Members of Parliament. 3. Unless otherwise specified when the vote is taken, amendments to these Rules and to their annexes shall enter into force on the first day of the part-session following that of their adoption. TITLE XIV MISCELLANEOUS PROVISIONS Rule 238 The symbols of the Union 1. Parliament shall recognise and espouse the following symbols of the Union: \u2014 the flag showing a circle of twelve golden stars on a blue background, \u2014 the anthem based on the \u2018Ode to Joy\u2019 from the Ninth Symphony by Ludwig van Beethoven, \u2014 the motto \u2018United in diversity\u2019. 2. Parliament shall celebrate Europe Day on 9 May. 3. The flag shall be flown at all Parliament premises and on the occasion of official events. The flag shall be used in each meeting room of the Parliament. 4. The anthem shall be performed at the opening of each constitutive sitting and at other solemn sittings, particularly those to welcome heads of State or government or to greet new Members following enlargements. 5. The motto shall be reproduced on Parliament's official documents. 6. The Bureau shall examine the further use of the symbols within the Parliament. The Bureau shall lay down detailed provisions for the implementation of this Rule. Rule 239 Gender Mainstreaming The Bureau shall adopt a gender action plan aimed at incorporating a gender perspective in all Parliament's activities, at all levels and all stages. The gender action plan shall be monitored bi-annually and reviewed at least every five years. Rule 240 Unfinished business At the end of the last part-session before elections, all Parliament's unfinished business shall be deemed to have lapsed, subject to the provisions of the second paragraph. At the beginning of each parliamentary term, the Conference of Presidents shall take a decision on reasoned requests from parliamentary committees and other institutions to resume or continue the consideration of such unfinished business. These provisions shall not apply to petitions, citizens' initiatives and communications that do not require a decision. Rule 241 Corrigenda 1. If an error is identified in a text adopted by Parliament, the President shall, where appropriate, refer a draft corrigendum to the committee responsible. 2. If an error is identified in a text adopted by Parliament and agreed with other institutions, the President shall seek the agreement of those institutions on the necessary corrections before proceeding in accordance with paragraph 1. 3. The committee responsible shall examine the draft corrigendum and submit it to Parliament if it is satisfied that an error has occurred which can be corrected in the proposed manner. 4. The corrigendum shall be announced at the following part-session. It shall be deemed to have been approved unless, not later than 24 hours after its announcement, a request is made by a political group or Members reaching at least the low threshold that it be put to the vote. If the corrigendum is not approved, it shall be referred back to the committee responsible. The committee responsible may propose an amended corrigendum or close the procedure. 5. Approved corrigenda shall be published in the same way as the text to which they refer. Rule 79 shall apply mutatis mutandis. (1) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (2) Interinstitutional Agreement of 20 November 2002 between the European Parliament and the Council concerning access by the European Parliament to sensitive information of the Council in the field of security and defence policy (OJ C 298, 30.11.2002, p. 1). Framework Agreement of 20 October 2010 on relations between the European Parliament and the European Commission (OJ L 304, 20.11.2010, p. 47). Interinstitutional Agreement of 12 March 2014 between the European Parliament and the Council concerning the forwarding to and handling by the European Parliament of classified information held by the Council on matters other than those in the area of the common foreign and security policy (OJ C 95, 1.4.2014, p. 1). (3) Decision of the European Parliament of 23 October 2002 on the implementation of the Interinstitutional Agreement governing European Parliament access to sensitive Council information in the sphere of security and defence policy (OJ C 298, 30.11.2002, p. 4). Decision of the Bureau of 15 April 2013 concerning the rules governing the treatment of confidential information by the European Parliament (OJ C 96, 1.4.2014, p. 1). (4) See Annex II. (5) See Annex I. (6) Agreement of 16 April 2014 between the European Parliament and the European Commission on the transparency register for organisations and self-employed individuals engaged in EU policy-making and policy implementation (OJ L 277, 19.9.2014, p. 11). (7) Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-fraud Office (OLAF) (OJ L 136, 31.5.1999, p. 15). (8) Parliament Decision of 18 November 1999 concerning the terms and conditions for internal investigations in relation to the prevention of fraud corruption and any illegal activity detrimental to the Communities' interests. (9) Rule 14 applies mutatis mutandis to committees (see Rule 213(3)). (10) Rule 15 applies mutatis mutandis to committees (see Rule 213(3)). (11) Rule 16 applies mutatis mutandis to committees (see Rule 213(3)). (12) Rule 19 applies mutatis mutandis to committees (see Rule 213(3)). (13) Rule 20 applies mutatis mutandis to committees (see Rule 213(3)). (14) See Annex I. (15) Framework Agreement of 20 October 2010 on relations between the European Parliament and the European Commission (OJ L 304, 20.11.2010, p. 47). (16) Interinstitutional Agreement of 13 April 2016 between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1). (17) Interinstitutional Agreement on Better-Law Making, paragraph 25. (18) See the relevant decision of the Conference of Presidents. (19) Code of Conduct for negotiating in the context of the ordinary legislative procedures. (20) Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (OJ C 373, 20.12.2013, p. 1). (21) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (22) See Annex V. (23) Interinstitutional Agreement of 20 December 1994, Accelerated working method for official codification of legislative texts, point 4 (OJ C 102, 4.4.1996, p. 2). (24) Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts (OJ C 77, 28.3.2002, p. 1), point 9. (25) Council Decision 1999/468/EC of 28 June 1999 laying down procedures for the exercise of the implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23). (26) Rule 112(4) shall be deleted from the Rules of Procedure as soon as the regulatory procedure with scrutiny has been totally removed from existing legislation. (27) See Annex VII. (28) See Annex III. (29) See Annex III. (30) Extended by Parliament's decision of 12 March 2019. (31) Rule 171(2) applies mutatis mutandis to committees (see Rule 216(4)). (32) Rule 174 applies mutatis mutandis to committees (see Rule 219). (33) Rule 179 applies mutatis mutandis to committees (see Rule 219). (34) Rule 180 applies mutatis mutandis to committees (see Rule 219). (35) Rule 181 applies mutatis mutandis to committees (see Rule 219). (36) Rule 182 applies mutatis mutandis to committees (see Rule 219). (37) Rule 183 applies mutatis mutandis to committees (see Rule 219). (38) Rule 185(1) applies mutatis mutandis to committees (see Rule 219). (39) Rule 186 applies mutatis mutandis to committees (see Rule 219). (40) Rule 187 applies mutatis mutandis to committees (see Rule 219). (41) Rule 189 applies mutatis mutandis to committees (see Rule 219). (42) Rule 190(3) and (4) applies mutatis mutandis to committees (see Rule 219). (43) Rule 191 applies mutatis mutandis to committees (see Rule 219). (44) Rule 192 applies mutatis mutandis to committees (see Rule 219). (45) Rule 193 applies mutatis mutandis to committees (see Rule 219). (46) Rule 195 applies mutatis mutandis to committees (see Rule 219). (47) Rule 200 applies mutatis mutandis to committees (see Rule 219). (48) Rule 201 applies mutatis mutandis to committees (see Rule 219). (49) Rule 204 (2), (3) and (5) applies mutatis mutandis to committees where a verbatim report is drawn up (see Rule 216(5)). (50) See Annex VI. (51) Decision 95/167/EC, Euratom, ECSC of the European Parliament, the Council and the Commission of 19 April 1995 on the detailed provisions governing the exercise of the European Parliament's right of inquiry (OJ L 113, 19.5.1995, p. 1.). (52) Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens' initiative (OJ L 65, 11.3.2011, p. 1). (53) Decision 94/262/ECSC, EC, Euratom of the European Parliament of 9 March 1994 on the regulations and general conditions governing the performance of the Ombudsman's duties (OJ L 113, 4.5.1994, p. 15). (54) Rule 235 shall only apply to European political parties and European political foundations within the meaning of Article 2 (3) and (4) of Regulation (EU, Euratom) No 1141/2014. (55) Regulation (EU, Euratom) No 1141/2014 of the European Parliament and of the Council of 22 October 2014 on the statute and funding of European political parties and European political foundations (OJ L 317, 4.11.2014, p. 1). ANNEX I CODE OF CONDUCT FOR MEMBERS OF THE EUROPEAN PARLIAMENT WITH RESPECT TO FINANCIAL INTERESTS AND CONFLICTS OF INTEREST Article 1 Guiding principles In exercising their duties, Members of the European Parliament: (a) are guided by and observe the following general principles of conduct: disinterest, integrity, openness, diligence, honesty, accountability and respect for Parliament's reputation; (b) act solely in the public interest and refrain from obtaining or seeking to obtain any direct or indirect financial benefit or other reward. Article 2 Main duties of Members In exercising their duties, Members of the European Parliament shall: (a) not enter into any agreement to act or vote in the interest of any other legal or natural person that would compromise their voting freedom, as enshrined in Article 6 of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage and Article 2 of the Statute for Members of the European Parliament; (b) not solicit, accept or receive any direct or indirect benefit or other reward, whether in cash or in kind, in exchange for specific behaviour in the scope of the Member's parliamentary work, and shall consciously seek to avoid any situation which might imply bribery, corruption, or undue influence; (c) not engage in paid professional lobbying directly linked to the Union decision-making process. Article 3 Conflicts of interest 1. A conflict of interest exists where a Member of the European Parliament has a personal interest that could improperly influence the performance of his or her duties as a Member. A conflict of interest does not exist where a Member benefits only as a member of the general public or of a broad class of persons. 2. Any Member who finds that he or she has a conflict of interest shall immediately take the necessary steps to address it, in accordance with the principles and provisions of this Code of Conduct. If the Member is unable to resolve the conflict of interest, he or she shall report this to the President in writing. In cases of ambiguity, the Member may seek advice in confidence from the Advisory Committee on the Conduct of Members, established under Article 7. 3. Without prejudice to paragraph 2, Members shall disclose, before speaking or voting in plenary or in one of Parliament's bodies, or if proposed as a rapporteur, any actual or potential conflict of interest in relation to the matter under consideration, where such conflict is not evident from the information declared pursuant to Article 4. Such disclosure shall be made in writing or orally to the chair during the parliamentary proceedings in question. Article 4 Declaration by Members 1. For reasons of transparency, Members of the European Parliament shall be personally responsible for submitting a declaration of financial interests to the President by the end of the first part-session after elections to the European Parliament (or within 30 days of taking up office with the Parliament in the course of a parliamentary term), in accordance with a form to be adopted by the Bureau pursuant to Article 9. They shall notify the President of any changes that have an influence on their declaration by the end of the month following each change occurring. 2. The declaration of financial interests shall contain the following information, which shall be provided in a precise manner: (a) the Member's occupation or occupations during the three-year period before he or she took up office with the Parliament, and his or her membership during that period of any boards or committees of companies, non-governmental organisations, associations or other bodies established in law; (b) any salary which the Member receives for the exercise of a mandate in another parliament; (c) any regular remunerated activity which the Member undertakes alongside the exercise of his or her office, whether as an employee or as a self-employed person; (d) membership of any boards or committees of any companies, non-governmental organisations, associations or other bodies established in law, or any other relevant outside activity that the Member undertakes, whether the membership or activity in question is remunerated or unremunerated; (e) any occasional remunerated outside activity (including writing, lecturing or the provision of expert advice), if the total remuneration of all the Member's occasional outside activities exceeds EUR 5 000 in a calendar year; (f) any holding in any company or partnership, where there are potential public policy implications or where that holding gives the Member significant influence over the affairs of the body in question; (g) any support, whether financial or in terms of staff or material, additional to that provided by Parliament and granted to the Member in connection with his or her political activities by third parties, whose identity shall be disclosed; (h) any other financial interests which might influence the performance of the Member's duties. For any item to be declared in accordance with the first subparagraph, Members shall, where appropriate, indicate whether it is remunerated or not; for items (a), (c), (d), (e) and (f), Members shall also indicate one of the following income categories: \u2014 Unremunerated, \u2014 EUR 1 to EUR 499 a month, \u2014 EUR 500 to EUR 1 000 a month, \u2014 EUR 1 001 to EUR 5 000 a month, \u2014 EUR 5 001 to EUR 10 000 a month, \u2014 above EUR 10 000 a month, with an indication of the nearest EUR 10 000 amount. Any income that Members receive in respect of each item declared in accordance with the first subparagraph, but not on a regular basis, shall be calculated on an annual basis, divided by twelve and placed in one of the categories set out in the second subparagraph. 3. The information provided to the President in accordance with this Article shall be published on Parliament's website in an easily accessible manner. 4. Members may not be elected as office-holders of Parliament or of one of its bodies, be appointed as a rapporteur or participate in an official delegation or interinstitutional negotiations, if they have not submitted their declaration of financial interests. 5. If the President receives information, which leads him or her to believe that the declaration of financial interests of a Member is substantially incorrect or out of date, the President may consult the advisory committee provided for in Article 7. Where appropriate, the President shall request the Member to correct his or her declaration within 10 days. The Bureau may adopt a decision applying paragraph 4 to Members who do not comply with the President's correction request. 6. Rapporteurs may voluntarily list in the explanatory statement to their report outside interests who have been consulted on matters pertaining to the subject of the report (1). Article 5 Gifts or similar benefits 1. Members of the European Parliament shall refrain from accepting, in the performance of their duties, any gifts or similar benefits, other than those with an approximate value of less than EUR 150 given in accordance with courtesy usage or those given to them in accordance with courtesy usage when they are representing Parliament in an official capacity. 2. Any gifts presented to Members in accordance with paragraph 1 when they are representing Parliament in an official capacity shall be handed over to the President and dealt with in accordance with implementing measures to be laid down by the Bureau pursuant to Article 9. 3. The provisions of paragraphs 1 and 2 shall not apply to the reimbursement of travel, accommodation and subsistence expenses of Members, or to the direct payment of such expenses by third parties, when Members attend, pursuant to an invitation and in the performance of their duties, at any events organised by third parties. The scope of this paragraph, and in particular the rules designed to ensure transparency, shall be specified in the implementing measures to be laid down by the Bureau pursuant to Article 9. Article 6 Activities of former Members Former Members of the European Parliament who engage in professional lobbying or representational activities directly linked to the European Union decision-making process should inform the European Parliament thereof and may not, throughout the period in which they engage in those activities, benefit from the facilities granted to former Members under the rules laid down by the Bureau to that effect (2). Article 7 Advisory Committee on the Conduct of Members 1. An Advisory Committee on the Conduct of Members (\u2018the Advisory Committee\u2019) is hereby established. 2. The Advisory Committee shall be composed of five members, appointed by the President at the beginning of his or her term of office from amongst the members of the Committee on Constitutional Affairs and the Committee on Legal Affairs, taking due account of the Members' experience and of political balance. Each member of the Advisory Committee shall serve as chair for six months on a rotating basis. 3. The President shall also, at the beginning of his or her term of office, appoint reserve members for the Advisory Committee, one for each political group not represented in the Advisory Committee. In the event of an alleged breach of this Code of Conduct by a member of a political group not represented in the Advisory Committee, the relevant reserve member shall serve as a sixth full member of the Advisory Committee for the purposes of investigation of that alleged breach. 4. Upon request by a Member, the Advisory Committee shall give him or her, in confidence and within 30 calendar days, guidance on the interpretation and implementation of the provisions of this Code of Conduct. The Member in question shall be entitled to rely on such guidance. At the request of the President, the Advisory Committee shall also assess alleged breaches of this Code of Conduct and advise the President on possible action to be taken. 5. The Advisory Committee may, after consulting the President, seek advice from outside experts. 6. The Advisory Committee shall publish an annual report of its work. Article 8 Procedure in the event of possible breaches of the Code of Conduct 1. Where there is reason to think that a Member of the European Parliament may have breached this Code of Conduct, the President shall, except in manifestly vexatious cases, refer the matter to the Advisory Committee. 2. The Advisory Committee shall examine the circumstances of the alleged breach, and may hear the Member concerned. Based on its findings, it shall make a recommendation to the President concerning a possible decision. In case of an alleged breach of the Code of Conduct by a permanent member or by a reserve member of the Advisory Committee, the member or reserve member concerned shall refrain from taking part in the proceedings of the Advisory Committee on that alleged breach. 3. If, taking into account that recommendation, and having invited the Member concerned to submit written observations, the President concludes that the Member concerned has breached the Code of Conduct, he or she shall adopt a reasoned decision laying down a penalty. The President shall notify that Member of the reasoned decision. The penalty may consist of one or more of the measures listed in Rule 176(4) to (6) of the Rules of Procedure. 4. The internal appeal procedures defined in Rule 177 of the Rules of Procedure shall be available to the Member concerned. Article 9 Implementation The Bureau shall lay down implementing measures for this Code of Conduct, including a monitoring procedure, and shall, when necessary, update the amounts referred to in Articles 4 and 5. The Bureau may bring forward proposals for revision of this Code of Conduct. (1) See Bureau Decision of 12 September 2016 on the implementation of the Inter-Institutional Agreement on the Transparency Register. (2) Bureau Decision of 12 April 1999 on facilities granted to former Members of the European Parliament. ANNEX II CODE OF APPROPRIATE BEHAVIOUR FOR MEMBERS OF THE EUROPEAN PARLIAMENT IN EXERCISING THEIR DUTIES 1. In exercising their duties, Members of the European Parliament will behave towards everyone working in the European Parliament with dignity, courtesy and respect and without prejudice or discrimination. 2. In exercising their duties, Members will behave in a professional manner and must refrain, in their relations with staff, from, in particular, degrading, insulting, offensive or discriminatory language or any other actions which are unethical, demeaning or unlawful. 3. Members may not, by their actions, incite or encourage staff to violate, circumvent or ignore the legislation in force, Parliament\u2019s internal rules or this Code, or tolerate such behaviour by staff under their responsibility. 4. With the aim of ensuring that the European Parliament functions effectively, Members will seek to ensure, exercising appropriate discretion, that any disagreements or conflicts involving staff under their responsibility are handled promptly, fairly and effectively. 5. Where necessary, Members will cooperate promptly and fully with the procedures in place for managing situations of conflict or harassment (psychological or sexual), including responding promptly to any allegations of harassment. Members should take part in specialised training organised for them on preventing conflict and harassment in the workplace and on good office management. 6. Members will sign a declaration confirming their commitment to complying with this Code. All declarations, whether signed or not, will be published on Parliament\u2019s website. 7. Members who have not signed the declaration relating to this Code may not be elected as office-holders of Parliament or of one of its bodies, be appointed as a rapporteur or participate in an official delegation or interinstitutional negotiations. ANNEX III CRITERIA FOR QUESTIONS FOR WRITTEN ANSWER UNDER RULES 138, 140 AND 141 1. Questions for written answer shall: \u2014 clearly specify the addressee to whom they are to be transmitted through the usual interinstitutional channels, \u2014 fall exclusively within the limits of the competences of the addressee, as laid down in the relevant Treaties or in legal acts of the Union, or within its sphere of activity, \u2014 be of general interest, \u2014 be concise and contain an understandable interrogation, \u2014 not exceed 200 words, \u2014 not contain offensive language, \u2014 not relate to strictly personal matters, \u2014 not contain more than three sub-questions. 2. Questions to the Council may not deal with the subject of an ongoing ordinary legislative procedure or with Council\u2019s budgetary functions. 3. Upon request, the Secretariat shall provide authors with advice on how to comply in an individual case with the criteria laid down in paragraph 1. 4. If an identical or similar question has been put and answered during the preceding six months, or to the extent that a question merely seeks information on the follow-up to a specific resolution of Parliament of a kind which the Commission has already provided in a written follow-up communication during the preceding six months, the Secretariat shall transmit to the author a copy of the previous question and answer or follow-up communication. The renewed question shall not be forwarded to the addressee unless the President so decides in the light of significant new developments and in response to a reasoned request by the author. 5. If a question seeks factual or statistical information that is already available to Parliament\u2019s research services, it shall not be forwarded to the addressee but rather to those services, unless the President decides otherwise upon request by the author. 6. Questions concerning related matters may be merged into a single question by the Secretariat and answered together. ANNEX IV GUIDELINES AND GENERAL PRINCIPLES TO BE FOLLOWED WHEN CHOOSING THE SUBJECTS TO BE INCLUDED ON THE AGENDA FOR THE DEBATE ON CASES OF BREACHES OF HUMAN RIGHTS, DEMOCRACY AND THE RULE OF LAW PROVIDED FOR UNDER RULE 144 Fundamental principles 1. Priority shall be given to motions for resolutions intended to lead to a vote in Parliament addressed to the Council, the Commission, the Member States, third countries or international bodies, before a particular event, provided that the current part-session is the only part-session of the European Parliament at which a vote can be held in time. 2. Motions for resolutions shall not exceed 500 words. 3. Subjects relating to the responsibilities of the European Union as laid down by the Treaties shall be given priority, provided they are of major importance. 4. The number of subjects chosen shall be such as to allow a debate commensurate with their importance and should not exceed three, including sub-chapters. Practical details 5. The fundamental principles applied in determining the choice of subjects to be included in the debate on cases of breaches of human rights, democracy and the rule of law shall be notified to Parliament and the political groups. Limitation and allocation of speaking time 6. In order to make better use of the time available, the President, after consulting the political group Chairs, shall reach agreement with the Council and the Commission on the limitation of the speaking time for their respective statements, if any, in the debate on cases of breaches of human rights, democracy and the rule of law. Deadline for tabling amendments 7. The deadline for tabling amendments shall allow sufficient time between their distribution in the official languages and the time set for the debate on the motions for resolutions to enable Members and political groups to give them due consideration. ANNEX V PROCEDURE FOR THE CONSIDERATION AND ADOPTION OF DECISIONS ON THE GRANTING OF DISCHARGE Article 1 Documents 1. The following documents shall be printed and distributed: (a) the revenue and expenditure account, the financial analysis and the balance sheet forwarded by the Commission; (b) the Annual Report and special reports of the Court of Auditors, accompanied by the Institutions' answers; (c) the statement of assurance as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors pursuant to Article 287 of the Treaty on the Functioning of the European Union; (d) the Council recommendation. 2. These documents shall be referred to the committee responsible. Any committee concerned may deliver an opinion. 3. If other committees wish to deliver opinions, the President shall set the time-limit within which these shall be communicated to the committee responsible. Article 2 Consideration of report 1. Parliament shall consider a report from the committee responsible concerning discharge by 30 April of the year following the adoption of the Court of Auditors' Annual Report as required by the Financial Regulation. 2. Parliament's Rules relating to amendments and voting shall apply unless otherwise provided in this Annex. Article 3 Content of the Report 1. The discharge report drawn up by the committee responsible shall comprise: (a) a proposal for a decision granting discharge or postponing the discharge decision (April part-session vote) or a proposal for a decision granting or refusing to grant discharge (October part-session vote); (b) a proposal for a decision closing the accounts of all the Union's revenue, expenditure, assets and liabilities; (c) a motion for a resolution containing comments accompanying the proposal for a decision referred to in point (a) including both an assessment of the Commission's budgetary management over the financial year and observations relating to the implementation of expenditure for the future; (d) as an Annex, a list of the documents received from the Commission and those requested but not received; (e) the opinions of the committees concerned. 2. If the committee responsible proposes postponing the discharge decision, the relevant motion for a resolution shall also set out, inter alia: (a) the reasons for postponement; (b) the further action that the Commission is expected to take and the deadlines for doing so; (c) the documents required for Parliament to take an informed decision. Article 4 Consideration and vote in Parliament 1. Any report by the committee responsible concerning the discharge shall be included on the agenda of the first part-session following its tabling. 2. Amendments shall be admissible only to the motion for a resolution tabled in accordance with Article 3(1)(c). 3. Unless otherwise stipulated in Article 5, the vote on the proposals for decisions and the motion for a resolution shall follow the order of Article 3. 4. Parliament shall decide by a majority of the votes cast, in accordance with Article 231 of the Treaty on the Functioning of the European Union. Article 5 Procedural variants 1. April part-session vote In the first instance, the discharge report shall propose either to grant or to postpone discharge. (a) If a proposal to grant discharge secures a majority, discharge is granted. This shall also constitute closure of the accounts. If a proposal to grant discharge fails to secure a majority, discharge shall be deemed to have been postponed and the committee responsible shall table a new report within six months containing a new proposal to grant or refuse to grant discharge. (b) If a proposal to postpone discharge is adopted, the committee responsible shall table a new report within six months containing a new proposal to grant or refuse to grant discharge. In this case the closure of accounts shall also be postponed and retabled with the new report. If a proposal to postpone discharge fails to secure a majority, discharge shall be deemed to have been granted. In this instance the decision shall also constitute closure of the accounts. The motion for resolution may still be put to the vote. 2. October part-session vote In the second instance, the discharge report shall propose either to grant or to refuse to grant discharge. (a) If a proposal to grant discharge secures a majority, discharge is granted. This shall also constitute closure of the accounts. If a proposal to grant discharge fails to secure a majority, this shall constitute refusal of discharge. A formal proposal to close the accounts for the year in question shall be submitted at a subsequent part-session at which the Commission shall be invited to make a statement. (b) If a proposal to refuse discharge secures a majority, a formal proposal to close the accounts for the year in question shall be submitted at a subsequent part-session at which the Commission shall be invited to make a statement. If a proposal to refuse discharge fails to secure a majority, discharge shall be deemed to have been granted. In this instance the decision shall also constitute closure of accounts. The motion for resolution may still be put to the vote. 3. In the event that the motion for resolution or the proposal on closure contains provisions which contradict Parliament's vote on the discharge, the President, after consulting the Chair of the committee responsible, may postpone that vote and fix a new deadline for tabling amendments. Article 6 Implementation of discharge decisions 1. The President shall forward any decision or resolution of Parliament adopted pursuant to Article 3 to the Commission and to each of the other institutions and shall arrange for their publication in the Official Journal of the European Union in the series appropriate to acts of a legislative character. 2. The committee responsible shall report to Parliament at least annually on the action taken by the institutions in response to the comments accompanying the discharge decisions and the other comments contained in Parliament's resolutions concerning the implementation of expenditure. 3. On the basis of a report by the committee responsible for budgetary control, the President, acting on behalf of Parliament, may bring an action before the Court of Justice of the European Union against the institution concerned, pursuant to Article 265 of the Treaty on the Functioning of the European Union, for failure to comply with the obligations deriving from the comments accompanying the discharge decision or the other resolutions concerning implementation of expenditure. ANNEX VI POWERS AND RESPONSIBILITIES OF STANDING COMMITTEES (1) I. Committee on Foreign Affairs Committee responsible for the promotion, implementation and monitoring of the Union's foreign policy as regards: 1. the common foreign and security policy (CFSP) and the common security and defence policy (CSDP); in this context the committee is assisted by a subcommittee on security and defence; 2. relations with other Union institutions and bodies, the UNO and other international organisations and interparliamentary assemblies for matters falling under its responsibility; 3. oversight of the European External Action Service; 4. the strengthening of political relations with third countries by means of comprehensive cooperation and assistance programmes or international agreements such as association and partnership agreements; 5. the opening, monitoring and concluding of negotiations concerning the accession of European States to the Union; 6. all legislation, programming and scrutiny of actions carried out under the European Instrument for Democracy and Human Rights, the European Neighbourhood Instrument, the Instrument for Pre-Accession Assistance, the Instrument contributing to Stability and Peace and the Partnership Instrument for cooperation with third countries, and the policies underpinning them; 7. the monitoring and follow-up of, inter alia, the European Neighbourhood Policy (ENP), in particular with regard to ENP Annual Progress Reports; 8. issues concerning democracy, the rule of law, human rights, including the rights of minorities, in third countries and the principles of international law; in this context the committee is assisted by a subcommittee on human rights, which should ensure coherence between all the Union's external policies and its human rights policy; without prejudice to the relevant rules, members from other committees and bodies with responsibilities in this field shall be invited to attend the meetings of the subcommittee. 9. Parliament's involvement in election observation missions, where appropriate in cooperation with other relevant committees and delegations. The committee provides political oversight to, and coordinates the work of, joint parliamentary committees and parliamentary cooperation committees as well as that of the interparliamentary delegations and ad hoc delegations falling within its remit. II. Committee on Development Committee responsible for: 1. the promotion, implementation and monitoring of the development and cooperation policy of the Union, notably: (a) political dialogue with developing countries, bilaterally and in the relevant international organisations and interparliamentary for a; (b) aid to, and cooperation agreements with, developing countries, notably oversight of effective aid funding and evaluation of output, including in relation to poverty eradication; (c) monitoring of the relationship between the policies of the Member States and those implemented at Union level; (d) promotion of democratic values, good governance and human rights in developing countries; (e) the implementation, monitoring and advancement of policy coherence with regard to development policy; 2. all legislation, programming and scrutiny of actions carried out under the Development Cooperation Instrument (DCI), the European Development Fund (EDF) \u2014 in close cooperation with national parliaments \u2014 and the Humanitarian Aid Instrument, as well as all matters related to humanitarian aid in developing countries and the policy underpinning them; 3. matters relating to the ACP-EU Partnership Agreement and relations with the relevant bodies; 4. matters relating to Overseas Countries and Territories (OCTs); 5. Parliament's involvement in election observation missions, when appropriate in cooperation with other relevant committees and delegations. The committee coordinates the work of the interparliamentary delegations and ad hoc delegations falling within its remit. III. Committee on International Trade Committee responsible for matters relating to the establishment, implementation and monitoring of the Union's common commercial policy and its external economic relations, in particular: 1. financial, economic and trade relations with third countries and regional organisations; 2. the common external tariff and trade facilitation as well as the external aspects of customs provisions and management; 3. the opening, monitoring, conclusion and follow-up of bilateral, multilateral and plurilateral trade agreements governing economic, trade and investment relations with third countries and regional organisations; 4. measures of technical harmonisation or standardisation in fields covered by instruments of international law; 5. relations with the relevant international organisations and international fora on trade-related matters, and with organisations promoting regional economic and commercial integration outside the Union; 6. relations with the WTO, including its parliamentary dimension. The committee liaises with the relevant interparliamentary and ad hoc delegations for the economic and trade aspects of relations with third countries. IV. Committee on Budgets Committee responsible for: 1. the multiannual financial framework of the Union's revenue and expenditure and the Union's system of own resources; 2. Parliament's budgetary prerogatives, namely the budget of the Union as well as the negotiation and implementation of interinstitutional agreements in this field; 3. Parliament's estimates according to the procedure defined in the Rules; 4. the budget of the decentralised bodies; 5. the financial activities of the European Investment Bank which are not part of European economic governance; 6. the budgetisation of the European Development Fund, without prejudice to the powers of the committee responsible for the ACP-EU Partnership Agreement; 7. financial implications and compatibility with the multiannual financial framework of all Union acts, without prejudice to the powers of the relevant committees; 8. keeping track of and assessing the implementation of the current budget notwithstanding Rule 98(1), transfers of appropriations, procedures relating to the establishment plans, administrative appropriations and opinions concerning buildings-related projects with significant financial implications; 9. the Financial Regulation, excluding matters relating to the implementation, management and control of the budget. V. Committee on Budgetary Control Committee responsible for: 1. the control of the implementation of the budget of the Union and of the European Development Fund, and the decisions on discharge to be taken by Parliament, including the internal discharge procedure and all other measures accompanying or implementing such decisions; 2. the closure, presenting and auditing of the accounts and balance sheets of the Union, its institutions and any bodies financed by it, including the establishment of appropriations to be carried over and the settling of balances; 3. the control of the financial activities of the European Investment Bank; 4. monitoring of the cost-effectiveness of the various forms of Union financing in the implementation of the Union's policies, involving, upon the Committee on Budgetary Control's request, the specialised committees and acting, upon the Committee on Budgetary Control's request, in cooperation with the specialised committees for the examination of special reports of the Court of Auditors; 5. relations with the European Anti-Fraud Office (OLAF), consideration of fraud and irregularities in the implementation of the budget of the Union, measures aimed at preventing and prosecuting such cases, the strict protection of the Union's financial interests and the relevant actions by the European Public Prosecutor in this field; 6. relations with the Court of Auditors, the appointment of its members and consideration of its reports; 7. the Financial Regulation as far as the implementation, management and control of the budget are concerned. VI. Committee on Economic and Monetary Affairs Committee responsible for: 1. the economic and monetary policies of the Union, the functioning of Economic and Monetary Union and the European monetary and financial system (including relations with the relevant institutions or organisations); 2. the free movement of capital and payments (cross-border payments, single payment area, balance of payments, capital movements and borrowing and lending policy, control of movements of capital originating in third countries, measures to encourage the export of the Union's capital); 3. the international monetary and financial system (including relations with financial and monetary institutions and organisations); 4. rules on competition and State or public aid; 5. tax provisions; 6. the regulation and supervision of financial services, institutions and markets including financial reporting, auditing, accounting rules, corporate governance and other company law matters specifically concerning financial services; 7. the relevant financial activities of the European Investment Bank as part of European economic governance in the euro area. VII. Committee on Employment and Social Affairs Committee responsible for: 1. employment policy and all aspects of social policy including working conditions, social security, social inclusion and social protection; 2. workers' rights; 3. health and safety measures at the workplace; 4. the European Social Fund; 5. vocational training policy, including professional qualifications; 6. the free movement of workers and pensioners; 7. social dialogue; 8. all forms of discrimination at the workplace and in the labour market except those based on sex; 9. relations with: \u2014 the European Centre for the Development of Vocational Training (Cedefop), \u2014 the European Foundation for the Improvement of Living and Working Conditions, \u2014 the European Training Foundation, \u2014 the European Agency for Safety and Health at Work; as well as relations with other relevant Union bodies and international organisations. VIII. Committee on the Environment, Public Health and Food Safety Committee responsible for: 1. environmental policy and environmental protection measures, in particular concerning: (a) climate change; (b) air, soil and water pollution, waste management and recycling, dangerous substances and preparations, noise levels and the protection of biodiversity; (c) sustainable development; (d) international and regional measures and agreements aimed at protecting the environment; (e) restoration of environmental damage; (f) civil protection; (g) the European Environment Agency; (h) the European Chemicals Agency; 2. public health, in particular: (a) programmes and specific actions in the field of public health; (b) pharmaceutical and cosmetic products; (c) health aspects of bioterrorism; (d) the European Medicines Agency and the European Centre for Disease Prevention and Control; 3. food safety issues, including in particular: (a) the labelling and safety of foodstuffs; (b) veterinary legislation concerning protection against risks to human health; public health checks on foodstuffs and food production systems; (c) the European Food Safety Authority and the European Food and Veterinary Office. IX. Committee on Industry, Research and Energy Committee responsible for: 1. the Union's industrial policy and related measures, and the application of new technologies, including measures related to SMEs; 2. the Union's research and innovation policy, including science and technology as well as the dissemination and exploitation of research findings; 3. European space policy; 4. the activities of the Joint Research Centre, the European Research Council, the European Institute of Innovation and Technology and the Institute for Reference Materials and Measurements, as well as JET, ITER and other projects in the same area; 5. Union measures relating to energy policy in general and in the context of the establishment and functioning of the internal energy market, including measures relating to: (a) the security of energy supply in the Union; (b) the promotion of energy efficiency and energy saving and the development of new and renewable forms of energy; (c) the promotion of interconnection of energy networks and energy efficiency including the establishment and development of trans-European networks in the energy infrastructure sector; 6. the Euratom Treaty and Euratom Supply Agency; nuclear safety, decommissioning and waste disposal in the nuclear sector; 7. the information society, information technology and communications networks and services, including technologies and security aspects and the establishment and development of trans-European networks in the telecommunication infrastructure sector as well as the activities of the European Union Agency for Network and Information Security (ENISA). X. Committee on the Internal Market and Consumer Protection Committee responsible for: 1. coordination at Union level of national legislation in the sphere of the internal market and for the customs union, in particular: (a) the free movement of goods including the harmonisation of technical standards; (b) the right of establishment; (c) freedom to provide services except in the financial and postal sectors; 2. the functioning of the Single Market, including measures aimed at the identification and removal of potential obstacles to the implementation of the Single Market, including the Digital Single Market; 3. the promotion and protection of the economic interests of consumers, except for public health and food safety issues; 4. policy and legislation regarding the enforcement of Single Market rules and consumer rights. XI. Committee on Transport and Tourism Committee responsible for: 1. matters relating to the development of a common policy for rail, road, inland waterway, maritime and air transport, in particular: (a) common rules applicable to transport within the European Union; (b) the establishment and development of trans-European networks in the area of transport infrastructure; (c) the provision of transport services and relations in the field of transport with third countries; (d) transport safety; (e) relations with international transport bodies and organisations; (f) the European Maritime Safety Agency, the European Union Agency for Railways, the European Union Aviation Safety Agency and the SESAR Joint Undertaking; 2. postal services; 3. tourism. XII. Committee on Regional Development Committee responsible for: 1. the operation and development of the Union's regional development and cohesion policy, as established in the Treaties; 2. the European Regional Development Fund, the Cohesion Fund and the other instruments of the Union's regional policy; 3. assessment of the impact of other Union policies on economic and social cohesion; 4. coordination of the Union's structural instruments; 5. the urban dimension of the cohesion policy; 6. outermost regions and islands as well as trans-frontier and interregional cooperation; 7. relations with the Committee of the Regions, interregional cooperation organisations and local and regional authorities. XIII. Committee on Agriculture and Rural Development Committee responsible for: 1. the operation and development of the common agricultural policy; 2. rural development, including the activities of the relevant financial instruments; 3. legislation on: (a) veterinary and plant-health matters and animal feeding stuffs provided such measures are not intended to protect against risks to human health; (b) animal husbandry and welfare; 4. improvement of the quality of agricultural products; 5. supplies of agricultural raw materials; 6. the Community Plant Variety Office; 7. forestry and agroforestry. XIV. Committee on Fisheries Committee responsible for: 1. the operation and development of the common fisheries policy and its management; 2. the conservation of fishery resources, the management of fisheries and fleets exploiting such resources and marine and applied fisheries research; 3. the common organisation of the market in fishery and aquaculture products and the processing and marketing thereof; 4. structural policy in the fisheries and aquaculture sectors, including the financial instruments and funds for fisheries guidance to support these sectors; 5. the integrated maritime policy as regards fishing activities; 6. sustainable fisheries partnership agreements, regional fisheries organisations and the implementation of international obligations in the field of fisheries. XV. Committee on Culture and Education Committee responsible for: 1. the cultural aspects of the European Union, and in particular: (a) improving the knowledge and dissemination of culture; (b) the protection and promotion of cultural and linguistic diversity; (c) the conservation and safeguarding of cultural heritage, cultural exchanges and artistic creation; 2. the Union's education policy, including the European higher education area, the promotion of the system of European schools and lifelong learning; 3. audiovisual policy and the cultural and educational aspects of the information society; 4. youth policy; 5. the development of a sports and leisure policy; 6. information and media policy; 7. cooperation with third countries in the areas of culture and education and relations with the relevant international organisations and institutions. XVI. Committee on Legal Affairs Committee responsible for: 1. the interpretation, application and monitoring of Union law and compliance of Union acts with primary law, notably the choice of legal bases and respect for the principles of subsidiarity and proportionality; 2. the interpretation and application of international law, in so far as the European Union is affected; 3. better law-making and the simplification of Union law; 4. the legal protection of Parliament's rights and prerogatives, including its involvement in actions before the Court of Justice of the European Union; 5. Union acts which affect the Member States' legal order, namely in the fields of: (a) civil and commercial law; (b) company law; (c) intellectual property law; (d) procedural law; 6. measures concerning judicial and administrative cooperation in civil matters; 7. environmental liability and sanctions against environmental crime; 8. ethical questions related to new technologies, applying the associated committee procedure with the relevant committees; 9. the Statute for Members and the Staff Regulations of the European Union; 10. privileges and immunities as well as verification of Members' credentials; 11. the organisation and statute of the Court of Justice of the European Union; 12. the European Union Intellectual Property Office. XVII. Committee on Civil Liberties, Justice and Home Affairs Committee responsible for: 1. the protection within the territory of the Union of citizens' rights, human rights and fundamental rights, including the protection of minorities, as laid down in the Treaties and in the Charter of Fundamental Rights of the European Union; 2. the measures needed to combat all forms of discrimination other than those based on sex or those occurring at the workplace and in the labour market; 3. legislation in the areas of transparency and of the protection of natural persons with regard to the processing of personal data; 4. the establishment and development of an area of freedom, security and justice while respecting the principles of subsidiarity and proportionality, in particular: (a) measures concerning the entry and movement of persons, asylum and migration; (b) measures concerning an integrated management of the common borders; (c) measures relating to police and judicial cooperation in criminal matters, including terrorism, and substantive and procedural measures relating to the development of a more coherent Union approach to criminal law; 5. the European Monitoring Centre for Drugs and Drug Addiction and the European Union Agency for Fundamental Rights, Europol, Eurojust, CEPOL, the European Public Prosecutor's Office and other bodies and agencies in the same area; 6. the determination of a clear risk of a serious breach by a Member State of the principles common to the Member States. XVIII. Committee on Constitutional Affairs Committee responsible for: 1. the institutional aspects of the European integration process, in particular the preparation, initiation and proceedings of ordinary and simplified Treaty revision procedures; 2. the implementation of the Treaties and the assessment of their operation; 3. the institutional consequences of enlargement negotiations of or withdrawal from the Union; 4. interinstitutional relations, including, with a view to their approval by Parliament, examination of interinstitutional agreements pursuant to Rule 148(2) of the Rules of Procedure; 5. uniform electoral procedure; 6. political parties and political foundations at European level, without prejudice to the competences of the Bureau; 7. the determination of the existence of a serious and persistent breach by a Member State of the principles common to the Member States; 8. the interpretation and application of the Rules of Procedure and proposals for amendments thereto. XIX. Committee on Women's Rights and Gender Equality Committee responsible for: 1. the definition, promotion and protection of women's rights in the Union and related Union measures; 2. the promotion of women's rights in third countries; 3. equal opportunities policy, including the promotion of equality between men and women with regard to labour market opportunities and treatment at work; 4. the removal of all forms of violence and discrimination based on sex; 5. the implementation and further development of gender mainstreaming in all policy sectors; 6. the follow-up and implementation of international agreements and conventions involving the rights of women; 7. the encouragement of awareness of women's rights. XX. Committee on Petitions Committee responsible for: 1. petitions; 2. the organisation of public hearings on citizens' initiatives pursuant to Rule 222; 3. relations with the European Ombudsman. (1) Adopted by decision of Parliament of 15 January 2014. ANNEX VII APPROVAL OF THE COMMISSION AND MONITORING OF COMMITMENTS MADE DURING THE HEARINGS Part I \u2014 Parliament's consent with regard to the entire College of the Commission Article 1 Basis for assessment 1. Parliament shall evaluate Commissioners-designate based on their general competence, European commitment and personal independence. It shall assess knowledge of their prospective portfolio and their communication skills. 2. Parliament shall have particular regard to gender balance. It may express itself on the allocation of portfolio responsibilities by the President-elect. 3. Parliament may seek any information relevant to its reaching a decision on the aptitude of the Commissioners-designate. It shall expect full disclosure of information relating to their financial interests. The declarations of interest of the Commissioners-designate shall be sent for scrutiny to the committee responsible for legal affairs. Article 2 Examination of declaration of financial interests 1. The committee responsible for legal affairs shall examine the declarations of financial interests and assess whether the content of the declaration made by a commissioner-designate is accurate and complete and whether it is possible to infer a conflict of interests. 2. The confirmation by the committee responsible for legal affairs of the absence of any conflict of interests is an essential precondition for the holding of the hearing by the committee responsible for the subject matter. In the absence of such confirmation, the procedure for appointing the Commissioner-designate shall be suspended while the procedure laid down in paragraph 3(c) is followed. 3. The following guidelines shall be applied when the declarations of financial interests are scrutinised by the committee responsible for legal affairs: (a) if, when scrutinising a declaration of financial interests, the committee responsible for legal affairs deems, on the basis of the documents presented, the declaration to be accurate, complete and to contain nothing indicating an actual or potential conflict of interests in connection with the portfolio of the Commissioner-designate, its Chair shall send a letter confirming this finding to the committees responsible for the hearing or to the committees involved in the event of a procedure taking place during a Commissioner's term of office; (b) if the committee responsible for legal affairs considers that the declaration of interests of a Commissioner-designate contains information which is incomplete or contradictory, or that there is a need for further information, it shall, pursuant to the Framework Agreement on relations between the European Parliament and the European Commission, request the Commissioner-designate to provide supplementary information without undue delay and shall consider and properly analyse it before making its decision; the committee responsible for legal affairs may decide, where appropriate, to invite the Commissioner-designate to a discussion; (c) if the committee responsible for legal affairs identifies a conflict of interests based on the declaration of financial interests or the supplementary information supplied by the Commissioner-designate, it shall draw up recommendations aimed at resolving the conflict of interests; the recommendations may include renouncing the financial interests in question or changes to the portfolio of the Commissioner-designate by the President of the Commission; in more serious cases, if no solution is found to the conflict of interests, and as a last resort, the committee responsible for legal affairs may conclude that the Commissioner-designate is unable to exercise his or her functions in accordance with the Treaties and the Code of Conduct; the President of Parliament shall then ask the President of the Commission what further steps the latter intends to take. Article 3 Hearings 1. Each Commissioner-designate shall be invited to appear before the appropriate committee or committees for a single hearing. 2. The hearings shall be organised by the Conference of Presidents on a recommendation of the Conference of Committee Chairs. The Chair and coordinators of each committee shall be responsible for the detailed arrangements. Rapporteurs may be appointed. 3. Appropriate arrangements shall be made to associate relevant committees where portfolios are mixed. There are three options: (a) if the portfolio of the Commissioner-designate falls within the remit of a single committee, the Commissioner-designate shall be heard by that committee alone (the committee responsible); (b) if the portfolio of the Commissioner-designate falls more or less equally within the remit of more than one committee, the Commissioner-designate shall be heard jointly by those committees (joint committees); and (c) if the portfolio of the Commissioner-designate falls mainly within the remit of one committee and only to a small extent within the remit of at least one other committee, the Commissioner-designate shall be heard by the committee mainly responsible, with the association of the other committee or committees (associated committees). 4. The President-elect of the Commission shall be fully consulted on the arrangements. 5. The committees shall submit written questions to the Commissioners-designate in good time before the hearings. For each Commissioner-designate there shall be two common questions drafted by the Conference of Committee Chairs, the first relating to the issues of general competence, European commitment and personal independence, and the second relating to the management of the portfolio and cooperation with Parliament. The committee responsible shall submit five other questions; sub-questions shall not be allowed. In the case of joint committees, they shall each be given the right to submit three questions. The curriculum vitae of the Commissioners-designate and their response to the written questions shall be published on Parliament's website in advance of the hearing. 6. Each hearing shall be scheduled to last three hours. Hearings shall take place in circumstances, and under conditions, in which Commissioners-designate enjoy an equal and fair opportunity to present themselves and their opinions. 7. Commissioners-designate shall be invited to make an opening oral statement of no longer than 15 minutes. Up to 25 questions, grouped together by theme whenever possible, shall be put during the course of the hearing. One follow up question may be asked immediately within the allocated time. The bulk of the speaking time shall be allotted to political groups, mutatis mutandis in accordance with Rule 171. The conduct of the hearings shall aim to develop a pluralistic political dialogue between the Commissioners-designate and the Members. Before the end of the hearing, the Commissioners-designate shall be given the opportunity to make a brief closing statement. 8. There shall be a live audio-visual transmission of the hearings made available free of charge to the public and media. An indexed recording of the hearings shall be made available to the public within 24 hours. Article 4 Evaluation 1. The Chair and coordinators shall meet without delay after the hearing to evaluate the individual Commissioners-designate. Those meetings shall be held in camera. The coordinators shall be invited to state whether, in their opinion, the Commissioners-designate are qualified both to be members of the College and to carry out the particular duties they have been assigned. The Conference of Committee Chairs shall design a pro forma template to assist the evaluation. 2. In the case of joint committees the Chair and the coordinators of the committees concerned shall act jointly throughout the procedure. 3. There shall be a single evaluation letter for each Commissioner-designate. The opinions of all the committees associated with the hearing shall be included. 4. The following principles shall apply to the coordinators' evaluation: (a) If the coordinators unanimously approve the Commissioner-designate, the Chair shall submit a letter of approval on their behalf. (b) If the coordinators unanimously reject the Commissioner-designate, the Chair shall submit a letter of rejection on their behalf. (c) If coordinators representing a majority of at least two-thirds of the committee membership approve the Commissioner-designate, the Chair shall submit a letter on their behalf stating that a large majority approve the Commissioner-designate. Minority views shall be mentioned upon request. (d) If coordinators cannot reach a majority of at least two-thirds of the committee membership to approve the candidate, they shall \u2014 first request additional information through further written questions, \u2014 if coordinators are still dissatisfied, request a resumed hearing of 1,5 hours subject to the approval of the Conference of Presidents; (e) If, further to the application of point (d), coordinators representing a majority of at least two-thirds of the committee membership approve the Commissioner-designate, the Chair shall submit a letter on their behalf stating that a large majority approve the Commissioner-designate. Minority views shall be mentioned upon request. (f) If, further to the application of point (d), there is still no majority of coordinators representing at least two-thirds of the committee membership to approve the Commissioner-designate, the Chair shall convene a committee meeting and put to vote the two questions mentioned in paragraph 1. The Chair shall submit a letter stating the committee's evaluation. 5. The committees' letters of evaluation shall be transmitted within 24 hours after the completion of the evaluation process. The letters shall be examined by the Conference of Committee Chairs and conveyed subsequently to the Conference of Presidents. Unless it decides to seek further information, the Conference of Presidents, following an exchange of views, shall declare the hearings closed and authorise the publication of all letters of evaluation. Article 5 Presentation of the college 1. The President-elect of the Commission shall be invited to present the whole College of Commissioners-designate and their programme at a sitting of Parliament which the President of the European Council and the President of the Council shall be invited to attend. The presentation shall be followed by a debate. In order to wind up the debate, a political group or Members reaching at least the low threshold may table a motion for resolution. Rule 132(3) to (8) shall apply. 2. Following the vote on the motion for resolution, Parliament shall vote on whether or not to give its consent to the appointment, as a body, of the President-elect and Commissioners-designate. Parliament shall decide by a majority of the votes cast, by roll call. It may defer the vote until the following sitting. Article 6 Monitoring of commitments made during the hearings The commitments made and priorities referred to by Commissioners-designate during the hearings shall be reviewed, throughout his or her mandate, by the committee responsible in the context of the annual structured dialogue with the Commission undertaken in accordance with paragraph 1 of Annex 4 to the Framework Agreement on relations between the European Parliament and the European Commission. Part II \u2014 Substantial portfolio change or change in the composition of the College of Commissioners during its term of office Article 7 Vacancy When a vacancy caused by resignation, compulsory retirement or death is to be filled, Parliament, acting with dispatch, shall invite the Commissioner-designate to participate in a hearing under the same conditions as those laid down in Part I. Article 8 Accession of a new Member State In the event of the accession of a new Member State, Parliament shall invite the Commissioner-designate to participate in a hearing under the same conditions as those laid down in Part I. Article 9 Substantial portfolio change In the event of a substantial portfolio change during the Commission's term of office, the Commissioners affected shall be invited to participate in a hearing under the same conditions as those laid down in Part I before taking up their new responsibilities Article 10 Vote in plenary By way of derogation from the procedure laid down in Rule 125(7), when the vote in plenary concerns the appointment of a single Commissioner, the vote shall be by secret ballot. ANNEX VIII REQUIREMENTS FOR THE DRAFTING OF ACTS ADOPTED IN ACCORDANCE WITH THE ORDINARY LEGISLATIVE PROCEDURE 1. Acts shall indicate the type of the act followed by the reference number, the names of both institutions which adopted it, the date of their signature and an indication of their subject-matter. 2. Acts shall contain the following: (a) \u2018The European Parliament and the Council of the European Union\u2019; (b) a reference to the provisions under which the act is adopted, preceded by the words \u2018Having regard to\u2019; (c) a citation containing a reference to proposals submitted, opinions obtained and consultations held; (d) a statement of the reasons on which the act is based, introduced by the word \u2018Whereas\u2019; (e) a phrase such as \u2018have adopted this Regulation\u2019 or \u2018have adopted this Directive\u2019 or \u2018have adopted this Decision\u2019, followed by the body of the act. 3. Acts shall be divided into articles, if appropriate grouped into parts, titles, chapters and sections. 4. The last article of an act shall specify the date of entry into force, where that date is before or after the twentieth day following publication. 5. The last article of an act shall be followed by: \u2014 the appropriate formulation, according to the relevant provisions of the Treaties, as to its applicability, \u2014 \u2018Done at \u2026\u2019, followed by the date on which the act was signed, \u2014 \u2018For the European Parliament The President\u2019, \u2018For the Council The President\u2019, followed by the name of the President of Parliament and of the President-in-Office of the Council at the time when the act was signed.", "summary": "European Parliament Rules of Procedure European Parliament Rules of Procedure SUMMARY OF: Rules of Procedure \u2014 9th parliamentary term WHAT IS THE AIM OF THE RULES? They establish the internal organisation and workings of the EU\u2019s only pan-European directly-elected institution. Under Article 232 of the Treaty on the Functioning of the European Union, the European Parliament has the power to adopt its own Rules of Procedure. The document covers all procedural aspects of parliamentary works. KEY POINTS The rules cover the following aspects of parliamentary life: Members of the European Parliament (MEPs): must exercise their mandate independently; enjoy certain privileges and immunities; must respect the MEPs\u2019 statute and several other legal obligations, including rules on the transparency of their financial interests. Parliamentary officers MEPs elect the President, 14 Vice-Presidents and 5 Questors by secret ballot for a term of 2.5 years. The President: has overall direction of the Parliament and its various operations;represents Parliament;ensures observance of the rules and maintains order;opens, suspends and closes sittings, chairs the debates and supervises voting;rules on the admissibility of amendments, of other texts put to the vote and of parliamentary questions; andrefers to parliamentary committees matters that concern them. Vice-Presidents have specific responsibilities and replace the President when necessary. Questors are responsible for administrative and financial matters directly concerning MEPs. The Bureau consists of the President and 14 Vice-Presidents. It decides on financial, organisational and administrative matters affecting the Parliament. The Conference of Presidents consists of the President and the Chairs of the political groups (see below). It organises the Parliament\u2019s political work and decides legislative planning. The Conference of Committee Chairs consists of the chairs of all standing and special parliamentary committees. It may make recommendations on committee work and plenary session agendas. The Conference of Delegation Chairs consists of the chairs of all Parliament delegations to parliaments elsewhere in the world. It may make recommendations on the work of delegations. Political groups are formed by MEPs on the basis of their political affinities. A minimum of 23 MEPs, elected in at least a quarter of EU Member States, is required to form a group. They receive financial and administrative support depending on their size. Some MEPs do not belong to a political group. They receive support for their parliamentary activities.Individual MEPs from different political groups may form a cross-party intergroup on specific issues such as animal welfare or public health. Legislative procedures ordinary legislative procedures (1st, 2nd and 3rd readings), where Parliament acts as co-legislator with the Council; consultation procedures, where Parliament submits an opinion on a draft legal act; consent procedures, where Parliament\u2019s agreement is necessary before adoption of a legal act. In the course of those legislative procedures, Parliament pays specific attention to issues like the respect for fundamental rights, the legal basis, the delegation of legislative powers, the financial compatibility and the respect for subsidiarity. Own-initiative procedures In the case of legislative own-initiative reports, Parliament requests the European Commission to submit proposals (Rule 47) or submits proposals in the cases provided for by the Treaties (Rule 46). Non-legislative reports Parliament can also prepare non-legislative own-initiative reports on specific subject matters: Constitutional matters, where rules cover the Parliament\u2019s role when the EU\u2019s treaties are amended, a new country joins the EU or an EU Member State decides to leave the EU. Budgetary procedures, where rules cover both the consideration of the annual EU budget and its multiannual financial framework. International agreements, where the Parliament\u2019s approval or opinion is required for international agreements. It may also be consulted on aspects of the EU\u2019s common foreign and security policy. Relations with other EU institutions and bodies The Parliament: elects the Commission President and the whole Commission; may adopt a motion of censure against the Commission; is involved in appointments to institutions like the European Central Bank and the Court of Auditors. Parliamentary questions MEPs may table written questions to the: the Council; the Commission; or the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy. They can also table oral questions, which are followed by a debate, to the Council or the Commission. Relations with national parliaments Parliament keeps national parliaments regularly informed of its activities. MEPs and national MPs meet occasionally in the Conference of Parliamentary Committees for Union Affairs. Sessions of Parliament Parliament holds 4-day plenary part-sessions 12 times a year in Strasbourg and additional part-sessions in Brussels. Detailed rules cover issues such as: speaking time;use of languages;distribution of documents;voting. Committees Standing committees prepare Parliament\u2019s decisions at plenary level by submitting reports and other documents in their specific field of competence. Special committees may be established for a given term and a specific subject area. Committees of inquiry may be set up to investigate alleged contraventions of EU law or possible maladministration. Interparliamentary delegations Parliament establishes joint committees with national parliaments around the world and cooperates with the Parliamentary Assembly of the Council of Europe. Petitions Any EU citizen may address a petition to Parliament on a matter which comes within the EU\u2019s fields of activity and which affects the petitioner directly. DATE OF ENTRY INTO FORCE They entered into force on 2 July 2019. BACKGROUND For the latest iteration of the rules of procedure, see: Rules of Procedure of the European Parliament (European Parliament) For more information, see: Compendium of the main legal acts related to the Rules of Procedure (European Parliament). MAIN DOCUMENTS Rules of Procedure \u2014 9th parliamentary term \u2014 July 2019 (OJ L 302, 22.11.2019, pp. 1-128) Rules of Procedure of the European Parliament 9th parliamentary term \u2014 June 2020 last update 03.07.2020"}
{"article": "26.6.2020 EN Official Journal of the European Union L 204/49 DECISION OF THE EUROPEAN DATA PROTECTION SUPERVISOR of 15 May 2020 adopting the Rules of Procedure of the EDPS THE EUROPEAN DATA PROTECTION SUPERVISOR Having regard to Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (1), and in particular Article 57(1)(q) thereof, Whereas: (1) Article 8 of the Charter of Fundamental Rights of the European Union and Article 16 of the Treaty on the Functioning of the European Union provide that compliance with the rules relating to the protection of individuals with regard to the processing of personal data concerning them shall be subject to control by an independent authority. (2) Regulation (EU) 2018/1725 provides for the establishment of an independent authority, referred to as the European Data Protection Supervisor (EDPS), responsible for ensuring that the fundamental rights and freedoms of natural persons, and in particular their right to data protection, with respect to the processing of personal data, are respected by the Union institutions, bodies, offices and agencies. (3) Regulation (EU) 2018/1725 also provides for the duties and powers of the EDPS as well as for the appointment of the European Data Protection Supervisor. (4) Regulation (EU) 2018/1725 further provides that the European Data Protection Supervisor should be assisted by a Secretariat and lays down a number of provisions concerning staff and budgetary matters. (5) Other provisions of Union law also provide for tasks and powers for the EDPS, in particular, Regulation (EU) 2016/679 of the European Parliament and of the Council (2), Directive (EU) 2016/680 of the European Parliament and of the Council (3), Regulation (EU) 2016/794 of the European Parliament and of the Council (4), Regulation (EU) 2018/1727 of the European Parliament and of the Council (5) and Regulation (EU) 2017/1939 of the European Parliament and of the Council (6). (6) After consulting the Staff Committee of the EDPS, HAS ADOPTED THIS DECISION: TITLE I MISSION, DEFINITIONS, GUIDING PRINCIPLES AND ORGANISATION CHAPTER I Mission and definitions Article 1 The EDPS The EDPS shall act in accordance with the provisions of Regulation (EU) 2018/1725, any other relevant Union legal act and this Decision, and follow the strategic priorities which the European Data Protection Supervisor may set out. Article 2 Definitions For the purposes of this Decision, the following definitions apply: (a) \u2018the Regulation\u2019 means Regulation (EU) 2018/1725; (b) \u2018GDPR\u2019 means Regulation (EU) 2016/679; (c) \u2018\u201binstitution\u2019 means a Union institution, body, office or agency subject to the Regulation or to any other Union legal act providing for tasks and powers for the European Data Protection Supervisor; (d) \u2018EDPS\u2019 means the European Data Protection Supervisor as a body of the Union; (e) \u2018European Data Protection Supervisor\u2019 means the European Data Protection Supervisor appointed by the European Parliament and the Council in accordance with Article 53 of the Regulation; (f) \u2018EDPB\u2019 means the European Data Protection Board as a body of the Union established by Article 68(1) of the GDPR; (g) \u2018EDPB\u2019 secretariat\u2019 means the secretariat of the EDPB established by Article 75 of the GDPR. CHAPTER II Guiding principles Article 3 Good governance, integrity and good administrative behaviour 1. The EDPS shall act in the public\u2019s interest as an expert as well as an independent, reliable, proactive and authoritative body in the field of privacy and personal data protection. 2. The EDPS shall act in accordance with the EDPS Ethics Framework. Article 4 Accountability and transparency 1. The EDPS shall periodically publish its strategic priorities and an Annual Report. 2. The EDPS, as a data controller, shall lead by example in respecting the applicable law on the protection of personal data. 3. The EDPS shall engage openly and transparently with the media and stakeholders and explain its activities to the public in a clear language. Article 5 Efficiency and effectiveness 1. The EDPS shall use state-of-the-art administrative and technical means to maximise the efficiency and effectiveness in carrying out its tasks, including internal communication and appropriate delegation of tasks. 2. The EDPS shall implement appropriate mechanisms and tools to ensure the highest level of quality management, such as internal control standards, a risk management process and the annual activity report. Article 6 Cooperation The EDPS shall promote cooperation among data protection supervisory authorities as well as with any other public authority whose activities may have an impact on privacy and personal data protection. CHAPTER III Organisation Article 7 Role of the European Data Protection Supervisor The European Data Protection Supervisor shall decide the strategic priorities of the EDPS and adopt the policy documents corresponding to the tasks and powers of the EDPS. Article 8 EDPS secretariat The European Data Protection Supervisor shall determine the organisational structure of the EDPS secretariat. Without prejudice to the Memorandum of Understanding between the EDPS and the EDPB of 25 May 2018, in particular relating to the EDPB secretariat, the structure shall reflect the strategic priorities set by the European Data Protection Supervisor. Article 9 The Director and the Appointing Authority 1. Without prejudice to the Memorandum of Understanding between the EDPS and the EDPB of 25 May 2018, in particular point VI(5) thereof, the Director shall exercise the powers vested in the Appointing Authority within the meaning of Article 2 of the Staff Regulations of officials of the European Union laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 (7) and the powers vested in who is authorised to conclude contracts of employment within the meaning of Article 6 of the Conditions of Employment of other servants of the European Union laid down by Regulation (EEC, Euratom, ECSC) No 259/68 and any other related powers resulting from other administrative decisions both internal to the EDPS or of an inter-institutional nature, insofar as the decision of the European Data Protection Supervisor on the exercise of the powers vested in the Appointing Authority and in who is authorised to conclude contracts of employment does not provide otherwise. 2. The Director may delegate the exercise of the powers referred to in paragraph 1 to the official responsible for the management of human resources. 3. The Director shall be the reporting officer for the Data Protection Officer, the Local Security Officer, the Local Information Security Officer, the Transparency Officer, the Legal Service Officer, the Ethics Officer and the Internal Control Coordinator for the tasks relating to these functions. 4. The Director shall assist the European Data Protection Supervisor to ensure consistency and overall coordination of the EDPS and on any other tasks delegated to him or her by the European Data Protection Supervisor. 5. The Director may adopt the EDPS decisions on the application of the restrictions based on the EDPS internal rules implementing Article 25 of the Regulation. Article 10 Management Meeting 1. The Management Meeting shall comprise the European Data Protection Supervisor, the Director and the Heads of Units and Sectors and shall ensure strategic oversight of the work of the EDPS. 2. Where the Management Meeting concerns issues relating to human resources, budget, finance or administrative matters relevant for the EDPB or the EDPB secretariat, it shall also comprise the Head of the EDPB secretariat. 3. The Management Meeting shall be chaired by the European Data Protection Supervisor, or in cases he or she is unable to attend the meeting, by the Director. As a rule, the Management Meeting shall take place once per week. 4. The Director shall ensure the proper functioning of the secretariat of the Management Meeting. 5. The meetings shall not be public. Discussions shall be confidential. Article 11 Delegation of tasks and deputising 1. The European Data Protection Supervisor may delegate to the Director, where appropriate and in accordance with the Regulation, the power to adopt and sign legally binding decisions, the substance of which has already been determined by the European Data Protection Supervisor. 2. The European Data Protection Supervisor may also delegate, where appropriate and in accordance with the Regulation, to the Director or to the Head of Unit or Head of Sector concerned, the power to adopt and sign other documents. 3. Where powers have been delegated to the Director pursuant to paragraphs 1 or 2, the Director may sub-delegate them to the Head of Unit or Head of Sector concerned. 4. Where the European Data Protection Supervisor is prevented from exercising his or her functions or the post is vacant and no European Data Protection Supervisor has been appointed, the Director, where appropriate and in accordance with the Regulation, shall perform tasks and duties of the European Data Protection Supervisor which are necessary and urgent to ensure business continuity. 5. Where the Director is prevented from exercising his or her functions or the post is vacant and no official has been designated by the European Data Protection Supervisor, the functions of the Director shall be exercised by the Head of Unit or Head of Sector with the highest grade or, in the event of equal grade, by the Head of Unit or Head of Sector with the highest seniority within the grade or, in the event of equal seniority, by the eldest. 6. If there is no Head of Unit or Head of Sector available to exercise the duties of the Director as specified under paragraph 5 and no official has been designated by the European Data Protection Supervisor, the official with the highest grade or, in the event of equal grade, the official with the highest seniority in the grade or, in the event of equal seniority, the one who is eldest, shall deputise. 7. Where any other hierarchical superior is prevented from exercising his/her duties, and no official has been designated by the European Data Protection Supervisor, the Director shall designate an official in agreement with the European Data Protection Supervisor. If no replacement has been designated by the Director, the official in the Unit or Sector concerned with the highest grade, or in the event of equal grade, the official with the highest seniority in the grade or, in the event of equal seniority, the one who is eldest, shall deputise. 8. Paragraphs 1 to 7 shall be without prejudice to the rules concerning delegation in respect of the powers conferred on the Appointing Authority or of the powers concerning financial matters as provided for in Articles 9 and 12. Article 12 Authorising Officer and Accounting Officer 1. The European Data Protection Supervisor shall delegate the powers of Authorising Officer to the Director in accordance with the charter of tasks and responsibilities concerning budget and administration of the EDPS provided in accordance with Article 72(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (8). 2. As regards budget matters relating to the EDPB, the Authorising Officer shall exercise his or her function in accordance with the Memorandum of Understanding between the EDPS and the EDPB. 3. The function of Accounting Officer of the EDPS, in accordance with the Decision of the European Data Protection Supervisor of 1 March 2017 (9), shall be performed by the Accounting Officer of the Commission. TITLE II MONITORING AND ENSURING THE APPLICATION OF THE REGULATION Article 13 Monitoring and ensuring the application of the Regulation The EDPS shall guarantee effective protection of rights and freedoms of individuals through monitoring and enforcement of the Regulation and of any other Union legal act providing for tasks and powers for the European Data Protection Supervisor. To that end, in the exercise of the investigative, corrective, authorisation and advisory powers, the EDPS may conduct compliance visits, surveys, bi-monthly visits, informal consultations or facilitate amicable settlements of complaints. Article 14 Transparency of replies to consultations by institutions on their processing of personal data and to requests for authorisations The EDPS may publish the replies to consultation by institutions on their processing of personal data in full or in part, taking applicable confidentiality and information security requirements into account. Authorisation decisions shall be published, taking applicable confidentiality and information security requirements into account. Article 15 Data Protection Officers notified by the institutions 1. A register of the appointments of Data Protection Officers notified to the EDPS by the institutions in accordance with the Regulation shall be kept by the EDPS. 2. The updated list of the Data Protection Officers of the institutions shall be published on the website of the EDPS. 3. The EDPS shall provide guidance to Data Protection Officers, in particular by participating in the meetings organised by the network of the Data Protection Officers of the institutions. Article 16 Handling of complaints 1. The EDPS shall not handle anonymous complaints. 2. The EDPS shall handle complaints submitted in writing, including in electronic form, in any official language of the Union and which provide details necessary for the complaint to be understood. 3. Where a complaint relating to the same facts has been lodged by the complainant with the European Ombudsman, the EDPS shall examine the admissibility of the complaint in accordance with the Memorandum of Understanding between the EDPS and the European Ombudsman. 4. The EDPS shall decide how to handle a complaint taking into account: (a) the nature and gravity of the alleged violations of data protection rules; (b) the importance of the damage that one or more data subjects have or may have suffered as result of the violation; (c) the potential overall importance of the case, also in relation to other public and private interests involved; (d) the likelihood of establishing that the violation has occurred; (e) the exact date on which the underlying events occurred, the conduct in question stopped generating effects, the effects were removed or an appropriate guarantee of such a removal was provided. 5. Where appropriate, the EDPS shall facilitate an amicable settlement of the complaint. 6. The EDPS shall suspend the investigation of a complaint pending a ruling by a court or a decision of another judicial or administrative body on the same matter. 7. The EDPS shall only disclose the identity of the complainant to the extent necessary for the proper conduct of the investigation. The EDPS shall not disclose any document related to the complaint, except for anonymised excerpts or summaries of the final decision, unless the person concerned consents to such disclosure. 8. If required by the circumstances of the complaint, the EDPS shall cooperate with the competent oversight authorities, including competent national supervisory authorities acting within the scope of their respective competences. Article 17 Outcome of complaints 1. The EDPS shall inform the complainant as soon as possible of the outcome of a complaint and of the action taken. 2. Where a complaint is found to be inadmissible or the investigation is discontinued, the EDPS shall, where appropriate, advise the complainant to refer to another competent authority. 3. The EDPS may decide to discontinue an investigation at the request of the complainant. This shall not prevent the EDPS from further investigating the subject matter of the complaint. 4. The EDPS may close an investigation where the complainant has failed to provide the information requested. The EDPS shall inform the complainant about this decision. Article 18 Review of complaints and judicial remedies 1. Where the EDPS issues a decision on a complaint, the complainant or institution concerned may request that the EDPS review its decision. Such a request shall be made within one month of the decision. The EDPS shall review its decision where the complainant or institution advances new factual evidence or legal arguments. 2. Upon issuing its decision on a complaint, the EDPS shall inform the complainant and the institution concerned that they have the right both to request a review of its decision and to challenge the decision before the Court of Justice of the European Union in accordance with Article 263 of the Treaty on the Functioning of the European Union. 3. Where following a request that it review its decision on a complaint, the EDPS issues a new, revised decision, the EDPS shall inform the complainant and the institution concerned that they may challenge this new decision before the Court of Justice of the European Union in accordance with Article 263 of the Treaty on the Functioning of the European Union. Article 19 Notification of a personal data breach to the EDPS by institutions 1. The EDPS shall provide a secure platform for the notification of a personal data breach by an institution and implement security measures for the exchange of information regarding a personal data breach. 2. Upon notification the EDPS shall acknowledge receipt to the institution concerned. TITLE III LEGISLATIVE CONSULTATION, TECHNOLOGY MONITORING, RESEARCH PROJECTS, COURT PROCEEDINGS Article 20 Legislative consultation 1. In response to requests from the Commission pursuant to Article 42(1) of the Regulation, the EDPS shall issue opinions or formal comments. 2. The opinions shall be published on the website of the EDPS in English, French and German. Summaries of opinions shall be published in the Official Journal of the European Union (C Series). Formal comments shall be published on the website of the EDPS. 3. The EDPS may decline to respond to a consultation where the conditions set out in Article 42 of the Regulation are not met, including where there is no impact on the protection of individuals\u2019 rights and freedoms with regard to data protection. 4. Where despite best efforts a joint opinion of the EDPS and the EDPB pursuant to Article 42(2) of the Regulation cannot be issued within the set deadline, the EDPS may issue an opinion on the same matter. 5. Where the Commission shortens a deadline applicable to a legislative consultation pursuant to Article 42(3) of the Regulation, the EDPS shall strive to respect the deadline set in so far as is reasonable and practicable, taking into account in particular the complexity of the subject matter, the length of the documentation and the completeness of the information provided by the Commission. Article 21 Technology monitoring The EDPS, in monitoring the development of information and communication technologies insofar as they have an impact on the protection of personal data, shall promote awareness and advise in particular on the principles of data protection by design and data protection by default. Article 22 Research projects The EDPS may decide to contribute to the Union\u2019s Framework Programmes and to serve on the advisory committees of research projects. Article 23 Action against institutions for breach of the Regulation The EDPS may refer the matter to the Court of Justice of the European Union, in case of non-compliance by an institution with the Regulation, in particular where the EDPS has not been consulted in cases provided for by Article 42(1) of the Regulation and in case of failure to effectively respond to enforcement action taken by the EDPS under Article 58 of the Regulation. Article 24 EDPS intervention in actions brought before the Court of Justice of the European Union 1. The EDPS may intervene in actions brought before the Court of Justice of the European Union in accordance with Article 58(4) of the Regulation, Article 43(3)(i) of Regulation (EU) 2016/794, Article 85(3)(g) of Regulation (EU) 2017/1939, and Article 40(3)(g) of Regulation (EU) 2018/1727. 2. When deciding whether to request leave to intervene or whether to accept an invitation from the Court of Justice of the European Union to do so, the EDPS shall take into account in particular: (a) whether the EDPS has been directly involved in the facts of the case in performing its supervisory tasks; (b) whether the case raises data protection issues that are either substantial in themselves or decisive to its outcome; and (c) whether intervention by the EDPS is likely to affect the outcome of the proceedings. TITLE IV COOPERATION WITH NATIONAL SUPERVISORY AUTHORITIES AND INTERNATIONAL COOPERATION Article 25 EDPS as a member of the European Data Protection Board The EDPS as a member of the EDPB shall aim to promote the Union perspective, and in particular the shared values referred to in Article 2 of the Treaty of the European Union. Article 26 Cooperation with national supervisory authorities under Article 61 of the Regulation 1. The EDPS shall cooperate with national supervisory authorities and with the joint supervisory authority established under Article 25 of Council Decision 2009/917/JHA (10) with a view to, in particular: (a) exchanging all relevant information, including best practices, as well as information in relation to requests to exercise monitoring, investigative and enforcement powers by competent national supervisory authorities; (b) developing and maintaining contact with relevant members and staff of the national supervisory authorities. 2. Where relevant, the EDPS shall engage in mutual assistance and take part in joint operations with national supervisory authorities, each acting within the scope of their respective competences as set out in the Regulation, the GDPR and other relevant acts of Union law. 3. The EDPS may take part upon invitation in an investigation by a supervisory authority or invite a supervisory authority to take part in an investigation in accordance with the legal and procedural rules applicable to the inviting party. Article 27 International cooperation 1. The EDPS shall promote best practices, convergence and synergies on the protection of personal data between the European Union and third countries and international organisations, including through participation in relevant regional and international networks and events. 2. Where appropriate, the EDPS shall engage in mutual assistance in the investigative and enforcement actions of supervisory authorities of third countries or international organisations. TITLE V GENERAL PROVISIONS Article 28 Consultation with the Staff Committee 1. The Staff Committee, representing the staff of the EDPS, including the EDPB secretariat, shall be consulted in good time on draft decisions relating to the implementation of the Staff Regulations of officials of the European Union and the Conditions of Employment of other servants of the European Union laid down by Regulation (EEC, Euratom, ECSC) No 259/68 and may be consulted on any other question of general interest concerning the staff. The Staff Committee shall be informed of any question related to the execution of its tasks. It shall issue its opinions within 10 working days of being consulted. 2. The Staff Committee shall contribute to the good functioning of the EDPS, including the EDPB secretariat by making proposals on organisational matters and working conditions. 3. The Staff Committee shall be composed of three members and three deputies, and elected for a period of two years by all staff of the EDPS, including the EDPB secretariat. Article 29 Data Protection Officer 1. The EDPS shall appoint a Data Protection Officer (DPO). 2. The DPO shall be consulted, in particular, when the EDPS as controller intends to apply a restriction based on the internal rules implementing Article 25 of the Regulation. 3. In accordance with point IV(2)(viii) of the Memorandum of Understanding between the EDPS and the EDPB, the EDPB has a separate DPO. In accordance with point IV(4) of the Memorandum of Understanding between the EDPS and the EDPB, the DPO of the EDPS and of the EDPB shall meet regularly in order to ensure that their decisions remain consistent. Article 30 Public access to documents and Transparency Officer of the EDPS The EDPS shall designate a Transparency Officer to ensure compliance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council (11), without prejudice to the handling of public access to documents requests by the EDPB secretariat in accordance with point IV(2)(iii) of the Memorandum of Understanding between the EDPS and the EDPB. Article 31 Languages 1. The EDPS is committed to the principle of multilingualism, as cultural and linguistic diversity is one of the cornerstones and assets of the European Union. The EDPS strives to find a balance between the principle of multilingualism and the obligation to ensure sound financial management and savings for the budget of the European Union, hence making a pragmatic use of its limited resources. 2. The EDPS shall respond to any person addressing it on a matter falling within its competence in one of the official languages of the European Union in the same language used to address it. All complaints, requests for information and any other requests may be sent to the EDPS in any of the official languages of the European Union, and shall be answered in the same language. 3. The website of the EDPS shall be available in English, French and German. Strategic documents of the EDPS, such as the strategy for the mandate of the European Data Protection Supervisor, shall be published in English, French and German. Article 32 Support services The EDPS may enter into cooperation agreements or service level agreements with other institutions, and may participate in inter-institutional calls for tenders resulting in framework contracts with third parties for the provision of support services to the EDPS and the EDPB. The EDPS may also sign contract with external service providers in accordance with the procurement rules applicable to the institutions. Article 33 Authentication of decisions 1. The decisions of the EDPS shall be authenticated by the apposition of the signature by the European Data Protection Supervisor or the Director as provided for in this Decision. Such signature may be handwritten or in electronic form. 2. In case of delegation or deputising in accordance with Article 11, the decisions shall be authenticated by the apposition of the signature of the person to whom the power has been delegated or of the person deputising. Such signature may be handwritten or in electronic form. Article 34 Remote working at EDPS and electronic documents 1. By decision of the European Data Protection Supervisor, the EDPS may implement a system of remote working by all or part of its staff. This decision shall be communicated to the staff and published on the EDPS and EDPB websites. 2. By decision of the European Data Protection Supervisor, the EDPS may determine the conditions of validity of electronic documents, electronic procedures and electronic means of transmission of documents for the EDPS\u2019 purposes. This decision shall be communicated to the staff and published on the EDPS website. 3. The Chair of the EDPB shall be consulted where those decisions concern the EDPB Secretariat. Article 35 Rules for the calculation of periods, dates and time limits The EDPS shall apply the rules for calculation of periods, dates and time limits established under Regulation (EEC, Euratom) No 1182/71 of the Council (12). TITLE VI FINAL PROVISIONS Article 36 Supplementary measures The European Data Protection Supervisor may further specify the provisions of this Decision by adopting implementing rules and supplementary measures relating to the functioning of the EDPS. Article 37 Repeal of Decision 2013/504/EU of the European Data Protection Supervisor Decision 2013/504/EU of the European Data Protection Supervisor (13) is repealed and replaced by this Decision. Article 38 Entry into force This Decision shall enter into force on the day following its publication in the Official Journal of the European Union. Done at Brussels, 15 May 2020. For the EDPS Wojciech Rafa\u0142 WIEWI\u00d3ROWSKI European Data Protection Supervisor (1) OJ L 295, 21.11.2018, p. 39. (2) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (3) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (4) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53). (5) Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, p. 138). (6) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (7) Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities and instituting special measures temporarily applicable to officials of the Commission (Conditions of Employment of Other Servants) (OJ L 56, 4.3.1968, p. 1). (8) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (9) Decision of the European Data Protection Supervisor (EDPS) of 1 March 2017 on the appointment of the European Commission Accounting Officer as the Accounting Officer of the EDPS. (10) Council Decision 2009/917/JHA of 30 November 2009 on the use of information technology for customs purposes (OJ L 323, 10.12.2009, p. 20). (11) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (12) Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits OJ L 124, 8.6.1971, p. 1). (13) Decision 2013/504/EU of the European Data Protection Supervisor of 17 December 2012 on the adoption of Rules of Procedure (OJ L 273, 15.10.2013, p. 41).", "summary": "Rules of Procedure of the European Data Protection Supervisor Rules of Procedure of the European Data Protection Supervisor SUMMARY OF: Decision of the European Data Protection Supervisor adopting the Rules of Procedure of the EDPS WHAT IS THE AIM OF THE RULES OF PROCEDURE? They replace the former rules of procedure for the European Data Protection Supervisor (EDPS) set out in Decision 2013/504/EU which it repeals. They set out the guiding principles of the EDPS, along with rules on internal decision-making processes, the organisation and working of the Secretariat, planning, internal administration, and the openness and transparency of the institution. KEY POINTS The role of EDPS is set out in Regulation (EU) 2018/1725 \u2014 see summary. The new rules take into account changes in EU data protection legislation, specifically: Regulation (EU) 2016/679, the General Data Protection Regulation \u2014 see summary; Directive (EU) 2016/680 on data protection by police and criminal justice authorities \u2014 see summary; Regulation (EU) 2018/1727 on Eurojust \u2014 see summary; Regulation (EU) 2018/1241 on ETIAS \u2014 see summary; Regulation (EU) 2017/1939 on the European Public Prosecutor\u2019s Office \u2014 see summary; Regulation (EU) 2016/794 on Europol \u2014 see summary. Guiding principles The rules require the EDPS to follow a number of guiding principles covering: good governance, integrity and good administrative behaviour \u2014 the EPDS must act in the public\u2019s interest as an expert, as well as an independent, reliable, proactive and authoritative body in the field of privacy and personal data protection; accountability and transparency; efficiency and effectiveness; cooperation. Role of the Supervisor The Supervisor\u2019s tasks include: deciding the strategic priorities of the EDPS; adopting policy documents corresponding to the tasks and powers of the EDPS; deciding on the organisational structure of the EDPS secretariat, reflecting the strategic priorities. Monitoring data protection The EDPS must guarantee effective protection of rights and freedoms of individuals through the monitoring and enforcement of Regulation (EU) 2018/1725 and any other EU law that sets out tasks and powers for the EDPS. In carrying out its investigative, corrective, authorisation and advisory powers, the EDPS may carry out compliance visits, surveys, bi-monthly visits and informal consultations or encourage amicable settlements of complaints. Complaints The EDPS handles written complaints taking into account a number of factors including: the nature and gravity of the alleged violations;the importance of the damage suffered;the potential overall importance of the case. It must inform the complainant as soon as possible. The complainant or institution concerned can ask the EDPS to review its decision. FROM WHEN DOES THE DECISION APPLY? It has applied since 27 June 2020. BACKGROUND Article 7 of the Charter of Fundamental Rights states that everyone has the right to respect for his or her private and family life, home and communications. Article 8 of the Charter of Fundamental Rights states that everyone has the right to personal data protection. Article 16 of the Treaty on the Functioning of the EU further develops that right. This article is the legal basis for any EU legislation on data protection. For more information, see: Data protection in the EU (European Commission)European Data Protection Supervisor. MAIN DOCUMENT Decision of the European Data Protection Supervisor of 15 May 2020 adopting the Rules of Procedure of the EDPS (OJ L 204, 26.6.2020, pp. 49-59) RELATED DOCUMENTS Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, pp. 138-183) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, pp. 39-98) Regulation (EU) 2018/1241 of the European Parliament and of the Council of 12 September 2018 amending Regulation (EU) 2016/794 for the purpose of establishing a European Travel Information and Authorisation System (ETIAS) (OJ L 236, 19.9.2018, pp. 72-73) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, pp. 1-71) Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part One \u2014 Principles \u2014 Title II \u2014 Provisions having general application \u2014 Article 16 (ex Article 286 TEC) (OJ C 202, 7.6.2016, p. 55) Charter of Fundamental Rights of the European Union \u2014 Title II \u2014 Freedoms \u2014 Article 8 \u2014 Protection of personal data (OJ C 202, 7.6.2016, p. 395) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, pp. 53-114) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) Successive amendments to Regulation (EU) 2016/679 have been incorporated into the original text. This consolidated version is of documentary value only. Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, pp. 89-131) See consolidated version. last update 31.07.2020"}
{"article": "15.12.2020 EN Official Journal of the European Union L 424/1 COUNCIL DECISION (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the third paragraph of Article 311 thereof, Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Parliament (1), Acting in accordance with a special legislative procedure, Whereas: (1) The system of own resources of the Union must ensure adequate resources for the orderly development of the policies of the Union, subject to the need for strict budgetary discipline. The development of the system of own resources can and should also contribute, to the greatest extent possible, to the development of the policies of the Union. (2) The Lisbon Treaty introduced changes to the provisions related to the system of own resources of the Union which enable the abolition of an existing category of own resources and the establishment of a new category. (3) The European Council of 7 and 8 February 2013 called upon the Council to continue working on the proposal of the Commission for a new own resource based on value added tax (VAT) to make it as simple and transparent as possible, to strengthen the link with Union VAT policy and the actual VAT receipts, and to ensure equal treatment of taxpayers in all Member States. (4) In June 2017 the Commission adopted a reflection paper on the future of EU finances. In it, the Commission proposed a range of options linking own resources more visibly to Union policies, in particular to the single market and to sustainable growth. According to the paper, in introducing new own resources, attention should be paid to their transparency, simplicity and stability, their consistency with Union policy objectives, their impact on competitiveness and sustainable growth, and their equitable breakdown among Member States. (5) The present system for determining the VAT-based own resource has been criticised repeatedly by the Court of Auditors, the European Parliament and Member States as overly complex. The European Council of 17 to 21 July 2020 has therefore concluded that it is appropriate to simplify the calculation of that own resource. (6) In order to better align the Union\u2019s financing instruments with its policy priorities, to better reflect the role of the general budget of the Union (\u2018the Union budget\u2019) in the functioning of the single market, to better support the objectives of Union policies and to reduce Member States\u2019 contributions based on gross national income (GNI) to the Union\u2019s annual budget, the European Council of 17 to 21 July 2020 concluded that over the coming years the Union would work towards reforming the system of own resources and introduce new own resources. (7) As a first step, a new category of own resources based on national contributions calculated on the basis of non-recycled plastic packaging waste should be introduced. In accordance with the European strategy for plastics, the Union budget can contribute to reduce pollution from plastic packaging waste. An own resource which is based on national contributions that are proportional to the quantity of plastic packaging waste that is not recycled in each Member State will provide an incentive to reduce the consumption of single-use plastics, foster recycling and boost the circular economy. At the same time, Member States will be free to take the most suitable measures to achieve those goals, in line with the principle of subsidiarity. In order to avoid an excessively regressive impact on national contributions, an adjustment mechanism with an annual lump sum reduction should be applied to contributions of Member States with a GNI per capita in 2017 below the EU average. The reduction should correspond to 3,8 kilograms multiplied by the population in 2017 of the Member States concerned. (8) The European Council of 17 to 21 July 2020 noted that, as a basis for additional own resources, the Commission will put forward in the first semester of 2021 proposals on a carbon border adjustment mechanism and on a digital levy with a view to their introduction at the latest by 1 January 2023. The European Council invited the Commission to put forward a revised proposal on the EU Emissions Trading System, possibly extending it to the aviation and maritime sectors. It concluded that the Union will, in the course of the multiannual financial framework for the period 2021-2027 (\u2018MFF 2021-2027\u2019), work towards the introduction of other own resources, which may include a Financial Transaction Tax. (9) The European Council of 17 to 21 July 2020 concluded that the own resources arrangements should be guided by the overall objectives of simplicity, transparency and equity, including fair burden-sharing. It also concluded that Denmark, the Netherlands, Austria and Sweden, and, in the context of the support for the recovery and resilience, as well as Germany, are to benefit from lump sum corrections to their annual GNI-based contributions for the period 2021-2027. (10) Member States should retain, by way of collection costs, 25 % of the amounts of traditional own resources collected by them. (11) The integration of the European Development Fund into the Union budget should be accompanied by an increase in the own resources ceilings established in this Decision. A sufficient margin between the payments and the own resources ceiling is necessary to ensure that the Union is able \u2013 under any circumstances \u2013 to fulfil its financial obligations, even in times of economic downturn. (12) A sufficient margin should be preserved under the own resources ceilings for the Union to cover all of its financial obligations and contingent liabilities falling due in any given year. The total amount of own resources allocated to the Union to cover annual appropriations for payments should not exceed 1,40 % of the sum of all the Member States\u2019 GNIs. The total annual amount of appropriations for commitments entered in the Union budget should not exceed 1,46 % of the sum of all the Member States\u2019 GNIs. (13) In order to keep the amount of financial resources put at the disposal of the Union unchanged, it is appropriate to adjust the own resources ceiling for appropriations for payments and for appropriations for commitments expressed as a percentage of GNI, in the event of amendments to Regulation (EU) No 549/2013 of the European Parliament and of the Council (2) which result in significant changes in the level of GNI. (14) The economic impact of the COVID-19 crisis underlines the importance of ensuring that the Union has sufficient financial capacity in the event of economic shocks. The Union needs to provide itself with the means to attain its objectives. Financial resources on an exceptional scale are required in order to address the consequences of the COVID-19 crisis without increasing the pressure on the finances of the Member States at a moment where their budgets are already under enormous pressure to finance national economic and social measures in relation to the crisis. An exceptional response should therefore take place at Union level. For that reason, it is appropriate to empower the Commission on an exceptional basis to borrow temporarily up to EUR 750 000 million in 2018 prices on capital markets on behalf of the Union. Up to EUR 360 000 million in 2018 prices of the funds borrowed would be used for providing loans and up to EUR 390 000 million in 2018 prices of the funds borrowed would be used for expenditure, both for the sole purpose of addressing the consequences of the COVID-19 crisis. (15) This exceptional response should address the consequences of the COVID-19 crisis and avoid its re-emergence. Therefore, support should be limited in time and the majority of the funding should be provided in the immediate aftermath of the crisis, meaning that legal commitments of a programme financed by these additional resources should be made by 31 December 2023. The approval of payments under the Recovery and Resilience Facility will be subject to the satisfactory fulfilment of the relevant milestones and targets set out in the Recovery and Resilience Plan, which will be assessed in accordance with the relevant procedure set out in the Regulation establishing a Recovery and Resilience Facility, which reflects the conclusions of the European Council of 17 to 21 July 2020. (16) To bear the liability related to the envisaged borrowing of funds, an extraordinary and temporary increase in the own resources ceilings is necessary. Therefore, for the sole purpose of covering all liabilities of the Union resulting from its borrowing to address the consequences of the COVID-19 crisis, the ceiling for appropriations for payments and the ceiling for appropriations for commitments should each be increased by 0,6 percentage points. The empowerment of the Commission to borrow funds on capital markets on behalf of the Union for the sole and exclusive purpose of financing measures to address the consequences of the COVID-19 crisis is closely related to the increase in the own resources ceilings foreseen in this Decision and, ultimately, to the functioning of the system of own resources of the Union. Accordingly, that empowerment should be included in this Decision. The unprecedented nature of this operation and the exceptional amount of the funds to be borrowed call for certainty about the overall volume of the Union\u2019s liability and the essential features of its repayment, as well as for the implementation of a diversified borrowing strategy. (17) The increase in the own resources ceilings is necessary since the ceilings would otherwise not be sufficient to ensure the availability of adequate resources that the Union needs to meet the liabilities resulting from the exceptional and temporary empowerment to borrow funds. The need to have recourse to this additional allocation will also only be temporary since the relevant financial obligations and contingent liabilities will decrease over time as the borrowed funds are repaid and the loans mature. Therefore, the increase should expire when all funds borrowed have been repaid and all contingent liabilities relating to loans provided on the basis of those funds have ceased, which should be by 31 December 2058 at the latest. (18) Activities of the Union to address the consequences of the COVID-19 crisis need to be significant and must take place over a relatively short period. The borrowing of funds needs to follow this timing. Therefore, new net borrowing activity should stop at the latest at the end of 2026. After 2026 borrowing operations should be strictly limited to refinancing operations to ensure an efficient debt management. The Commission, when implementing the operations through a diversified funding strategy, should make the best use of the capacity of the markets to absorb the borrowing of such significant amounts of funds with different maturities, including short-term financing for the purpose of cash management, and ensuring the most advantageous repayment conditions. In addition, the Commission should regularly and comprehensively inform the European Parliament and the Council about all aspects of its debt management. Once the payment schedules for the policies to be funded by the borrowing are known, the Commission will communicate an issuance calendar containing the expected issuance dates and expected volumes for the forthcoming year as well as a plan setting out the expected principal and interest payments to the European Parliament and the Council. The Commission should update that calendar regularly. (19) The repayment of funds borrowed for the purpose of providing non-repayable support, providing repayable support through financial instruments or provisioning for budgetary guarantees, as well as payment of the interest due, should be funded by the Union budget. The borrowed funds which are used to provide loans to Member States should be repaid using the sums received from the beneficiary Member States. The necessary resources need to be allocated and made available to the Union for it to be able to cover all of its financial obligations and contingent liabilities resulting from the exceptional and temporary empowerment to borrow funds in any given year and under any circumstances, in compliance with Article 310(4) and Article 323 of the Treaty on the Functioning of the European Union (TFEU). (20) Amounts not used for interest payments as foreseen will be used for early repayments before the end of the MFF 2021-2027, with a minimum amount, and can be increased above this level provided that new own resources have been introduced after 2021 in accordance with the procedure set out in the third paragraph of Article 311 TFEU. All liabilities incurred by the exceptional and temporary empowerment to borrow funds should be fully repaid by 31 December 2058. In order to ensure the efficient budgetary management of the appropriations needed to cover repayments for the funds borrowed, it is appropriate to provide for the possibility of underlying budgetary commitments being broken down in annual instalments. (21) The schedule of repayments should respect the principle of sound financial management and cover the entire volume of funds borrowed under the empowerment of the Commission with a view to achieving a steady and predictable reduction of liabilities during the overall period. For that purpose, the amounts due by the Union in a given year for the repayment of the principal should not exceed 7,5 % of the maximum amount of EUR 390 000 million for expenditure. (22) Given the features of the exceptional, temporary and limited empowerment of the Commission to borrow funds for the purpose of addressing the consequences of the COVID-19 crisis, it should be clarified that, as a rule, the Union should not use funds borrowed on capital markets for the financing of operational expenditure. (23) In order to ensure that the Union is always able to fulfil its legal obligations in respect of third parties in a timely manner, specific rules should be provided by this Decision authorising the Commission, during the period of the temporary increase in the own resources ceilings, to call on Member States to provisionally make available the relevant cash resources if the authorised appropriations entered in the Union budget are not sufficient to cover liabilities arising from the borrowing linked to that temporary increase. The Commission should, as its last resort, only be able to call cash resources if it cannot generate the necessary liquidity by activating other measures of active cash management, including, if necessary, through a recourse to short-term financing on capital markets, in order to ensure timely compliance with the Union\u2019s obligations towards lenders. It is appropriate to provide that such calls should be announced by the Commission to Member States duly in advance and should be strictly pro rata to the estimated budget revenue of each Member State, and in any case, limited to their share of the temporarily increased own resources ceiling, that is 0,6 % of Member States\u2019 GNI. However, if a Member State fails, in full or in part, to honour a call on time, or if it notifies the Commission that it will not be able to honour a call, the Commission should nevertheless be authorised on a provisional basis to make additional calls on other Member States on a pro rata basis. It is appropriate to provide a maximum amount that the Commission may annually call from a Member State. The Commission is expected to submit the necessary proposals for the purpose of entering the expenditure covered by the amounts of cash resources provisionally provided by the Member States in the Union budget in order to ensure that those resources are taken into account as early as possible for the purpose of crediting own resources to accounts by the Member States, i.e. in accordance with the applicable legal framework and thus on the basis of the respective GNI keys and without prejudice to other own resources and other revenues. (24) Under the fourth paragraph of Article 311 TFEU, a Council regulation laying down implementing measures for the system of own resources of the Union will be adopted. Those measures should include provisions of a general and technical nature that are applicable to all categories of own resources. Those measures should include detailed rules for the calculation and budgeting of the balance, as well as the provisions and arrangements necessary for controlling and supervising the collection of own resources. (25) This Decision should enter into force only once it has been approved by all Member States in accordance with their respective constitutional requirements thus fully respecting national sovereignty. The European Council of 17 to 21 July 2020 noted the intention of Member States to proceed with the approval of this Decision as soon as possible. (26) For reasons of consistency, continuity and legal certainty, it is necessary to lay down provisions to ensure a smooth transition from the system introduced by Council Decision 2014/335 EU, Euratom (3) to that provided for in this Decision. (27) Decision 2014/335/EU, Euratom should be repealed. (28) For the purposes of this Decision, all monetary amounts should be expressed in euro. (29) Due to the need to urgently enable borrowing with a view to financing measures to address the consequences of the COVID-19 crisis, this Decision should enter into force on the first day of the first month following receipt of the last of the notifications of the completion of the procedures for the adoption of this Decision. (30) In order to ensure the transition to the revised system of own resources and to make this Decision coincide with the financial year, this Decision should apply from 1 January 2021, HAS ADOPTED THIS DECISION: Article 1 Subject matter This Decision lays down rules on the allocation of own resources to the Union in order to ensure the financing of the Union\u2019s annual budget. Article 2 Categories of own resources and specific methods for their calculation 1. Revenue from the following shall constitute own resources entered in the Union budget: (a) traditional own resources consisting of levies, premiums, additional or compensatory amounts, additional amounts or factors, Common Customs Tariff duties and other duties established or to be established by the institutions of the Union in respect of trade with third countries, customs duties on products under the expired Treaty establishing the European Coal and Steel Community, as well as contributions and other duties provided for within the framework of the common organisation of the markets in sugar; (b) the application of a uniform call rate of 0,30 % for all Member States to the total amount of VAT receipts collected in respect of all taxable supplies divided by the weighted average VAT rate calculated for the relevant calendar year as stipulated in Council Regulation (EEC, Euratom) No 1553/89 (4). For each Member State the VAT base to be taken into account for this purpose shall not exceed 50 % of GNI; (c) the application of a uniform call rate to the weight of plastic packaging waste generated in each Member State that is not recycled. The uniform call rate shall be EUR 0,80 per kilogram. An annual lump sum reduction for certain Member States as defined in the third subparagraph of paragraph 2 shall apply; (d) the application of a uniform call rate, to be determined pursuant to the budgetary procedure in the light of the total of all other revenue, to the sum of GNI of all the Member States. 2. For the purposes of point (c) of paragraph 1 of this Article, \u2018plastic\u2019 shall mean a polymer within the meaning of point (5) of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (5), to which additives or other substances may have been added; \u2018packaging waste\u2019 and \u2018recycling\u2019 shall have the meaning assigned to those terms in points (2) and (2c) of Article 3 of European Parliament and Council Directive 94/62/EC (6) respectively, and as used in Commission Decision 2005/270/EC (7). The weight of plastic packaging waste that is not recycled shall be calculated as the difference between the weight of the plastic packaging waste generated in a Member State in a given year and the weight of the plastic packaging waste recycled in that year that is determined pursuant to Directive 94/62/EC. The following Member States shall be entitled to annual lump sum reductions, expressed in current prices, to be applied to their respective contributions under point (c) of paragraph 1 in the amount of EUR 22 million for Bulgaria, EUR 32,1876 million for Czechia, EUR 4 million for Estonia, EUR 33 million for Greece, EUR 142 million for Spain, EUR 13 million for Croatia, EUR 184,0480 million for Italy, EUR 3 million for Cyprus, EUR 6 million for Latvia, EUR 9 million for Lithuania, EUR 30 million for Hungary, EUR 1,4159 million for Malta, EUR 117 million for Poland, EUR 31,3220 million for Portugal, EUR 60 million for Romania, EUR 6,2797 million for Slovenia and EUR 17 million for Slovakia. 3. For the purposes of point (d) of paragraph 1, the uniform call rate shall apply to the GNI of each Member State. GNI as referred to in point (d) of paragraph 1 means annual GNI at market prices, as provided by the Commission in application of Regulation (EU) No 549/2013. 4. For the period 2021-2027, the following Member States shall benefit from a gross reduction in their annual GNI-based contributions under point (d) of paragraph 1 in the amount of EUR 565 million for Austria, EUR 377 million for Denmark, EUR 3 671 million for Germany, EUR 1 921 million for the Netherlands and EUR 1 069 million for Sweden. Those amounts shall be measured in 2020 prices and adjusted to current prices by applying the most recent gross domestic product deflator for the Union expressed in euro, as provided by the Commission, which is available when the draft budget is drawn up. Those gross reductions shall be financed by all Member States. 5. If, at the beginning of the financial year, the Union budget has not been adopted, the previous uniform call rates based on GNI shall continue to apply until the entry into force of the new rates. Article 3 Own resources ceilings 1. The total amount of own resources allocated to the Union to cover annual appropriations for payments shall not exceed 1,40 % of the sum of all the Member States\u2019 GNIs. 2. The total annual amount of appropriations for commitments entered in the Union budget shall not exceed 1,46 % of the sum of all the Member States\u2019 GNIs. 3. An orderly ratio between appropriations for commitments and appropriations for payments shall be maintained to guarantee their compatibility and to enable the ceiling set in paragraph 1 to be complied with in subsequent years. 4. Where amendments to Regulation (EU) No 549/2013 result in significant changes in the level of GNI, the Commission shall recalculate the ceilings set out in paragraphs 1 and 2 as temporarily increased in accordance with Article 6 on the basis of the following formula: where: \u2014 \u2018x %\u2019 is the own resources ceiling for appropriations for payments; \u2014 \u2018y %\u2019 is the own resources ceiling for appropriations for commitments; \u2014 \u2018t\u2019 is the latest full year for which the data defined by Regulation (EU) 2019/516 (8) is available, \u2014 \u2018ESA\u2019 is the European system of national and regional accounts in the Union. Article 4 Use of funds borrowed on capital markets The Union shall not use funds borrowed on capital markets for the financing of operational expenditure. Article 5 Extraordinary and temporary additional means to address the consequences of the COVID-19 crisis 1. For the sole purpose of addressing the consequences of the COVID-19 crisis through the Council Regulation establishing a European Union Recovery Instrument and the sectoral legislation referred to therein: (a) the Commission shall be empowered to borrow funds on capital markets on behalf of the Union up to EUR 750 000 million in 2018 prices. The borrowing operations shall be carried out in euro; (b) up to EUR 360 000 million in 2018 prices of the funds borrowed may be used for providing loans and, by way of derogation from Article 4, up to EUR 390 000 million in 2018 prices of the funds borrowed may be used for expenditure. The amount referred to in point (a) of the first subparagraph shall be adjusted on the basis of a fixed deflator of 2 % per year. Each year the Commission shall communicate to the European Parliament and the Council the amount as adjusted. The Commission shall manage the borrowing referred to in point (a) of the first subparagraph so that no new net borrowing takes place after 2026. 2. The repayment of the principal of the funds borrowed to be used for expenditure as referred to in point (b) of the first subparagraph of paragraph 1 of this Article and the related interest due shall be borne by the Union budget. The budgetary commitments may be broken down over several years into annual instalments in accordance with Article 112(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (9). The repayment of the funds referred to in point (a) of the first subparagraph of paragraph 1 of this Article shall be scheduled, in accordance with the principle of sound financial management, so as to ensure the steady and predictable reduction of liabilities. Repayments of the principal of the funds shall start before the end of the MFF 2021-2027 period, with a minimum amount, insofar as amounts not used for interest payments due under the borrowing referred to in paragraph 1 of this Article allow it, with due regard to the procedure set out in Article 314 TFEU. All liabilities incurred by the exceptional and temporary empowerment of the Commission to borrow funds referred to in paragraph 1 of this Article shall be fully repaid at the latest by 31 December 2058. The amounts due by the Union in a given year for the repayment of the principal of the funds referred to in the first subparagraph of this paragraph shall not exceed 7,5 % of the maximum amount to be used for expenditure referred to in point (b) of the first subparagraph of paragraph 1. 3. The Commission shall establish the necessary arrangements for the administration of the borrowing operations. The Commission shall regularly and comprehensively inform the European Parliament and the Council about all aspects of its debt management strategy. The Commission shall establish an issuance calendar containing the expected issuance dates and volumes for the forthcoming year as well as a plan setting out the expected principal and interest payments, and communicate it to the European Parliament and the Council. The Commission shall update that calendar regularly. Article 6 Extraordinary and temporary increase in the own resources ceilings for the allocation of the resources necessary for addressing the consequences of the COVID-19 crisis The ceilings set out in Article 3(1) and (2) shall each be temporarily increased by 0,6 percentage points for the sole purpose of covering all liabilities of the Union resulting from the borrowing referred to in Article 5 until all such liabilities have ceased to exist, and at the latest by 31 December 2058. The increase in the own resources ceilings shall not be used to cover any other liabilities of the Union. Article 7 Universality principle The revenue referred to in Article 2 shall be used without distinction to finance all expenditure entered in the Union\u2019s annual budget. Article 8 Carry-over of surplus Any surplus of the Union\u2019s revenue over total actual expenditure during a financial year shall be carried over to the following financial year. Article 9 Collecting own resources and making them available to the Commission 1. The own resources referred to in point (a) of Article 2(1) shall be collected by the Member States in accordance with the national provisions imposed by law, regulation or administrative action. Member States shall, where appropriate, adapt those provisions to meet the requirements of Union rules. The Commission shall examine the relevant national provisions communicated to it by Member States, transmit to Member States the adjustments it deems necessary in order to ensure that they comply with Union rules and report, if necessary, to the European Parliament and the Council. 2. Member States shall retain, by way of collection costs, 25 % of the amounts referred to in point (a) of Article 2(1). 3. Member States shall make the own resources provided for in Article 2(1) of this Decision available to the Commission, in accordance with regulations adopted under Article 322(2) TFEU. 4. Without prejudice to Article 14(2) of Council Regulation (EU, Euratom) No 609/2014 (10), if the authorised appropriations entered in the Union budget are not sufficient for the Union to comply with its obligations resulting from the borrowing referred to in Article 5 of this Decision and the Commission cannot generate the necessary liquidity by activating other measures provided for by the financial arrangements applying to such borrowing in time to ensure compliance with the Union\u2019s obligations, including through active cash management and, if necessary, through a recourse to short-term financing on capital markets consistent with the conditions and limits set out in point (a) of the first subparagraph of Article 5(1) and Article 5(2) of this Decision, the Member States, as the Commission\u2019s last resort, shall make the resources necessary for that purpose available to the Commission. In such cases, paragraphs 5 to 9 of this Article shall apply by way of derogation from Article 14(3) and from the first subparagraph of Article 14(4) of Regulation (EU, Euratom) No 609/2014. 5. Subject to the second subparagraph of Article 14(4) of Regulation (EU, Euratom) No 609/2014, the Commission may call on the Member States to provisionally provide the difference between the overall assets and the cash resource requirements, in proportion (\u2018pro rata\u2019) to the estimated budget revenue of each of them. The Commission shall announce such calls to Member States duly in advance. The Commission will establish a structured dialogue with national debt management offices and treasuries in respect of its issuance and repayment schedules. If a Member State fails, in full or in part, to honour a call on time, or if it notifies the Commission that it will not be able to honour a call, in order to cover for the part corresponding to the Member State concerned, the Commission shall provisionally have the right to make additional calls on the other Member States. Such calls shall be pro rata to the estimated budget revenue of each of the other Member States. The Member State which failed to honour a call shall remain liable to honour it. 6. The maximum total annual amount of cash resources that may be called from a Member State under paragraph 5 shall in all circumstances be limited to its GNI-based relative share in the extraordinary and temporary increase in the own resources ceiling as referred to in Article 6. For this purpose, the GNI-based relative share shall be calculated as the share in the total GNI of the Union, as resulting from the respective column in the revenue part of the last adopted annual Union budget. 7. Any provision of cash resources pursuant to paragraphs 5 and 6 shall be compensated without delay in line with the applicable legal framework for the Union budget. 8. The expenditure covered by the amounts of cash resources provisionally provided by Member States in accordance with paragraph 5 shall be entered in the Union budget without delay in order to ensure that the related revenue is taken into account as early as possible for the purpose of crediting own resources to accounts by the Member States in accordance with the relevant provisions of Regulation (EU, Euratom) No 609/2014. 9. On an annual basis, the application of paragraph 5 shall not lead to calling cash resources in excess of the own resources ceilings referred to in Article 3 as increased in accordance with Article 6. Article 10 Implementing measures The Council shall lay down implementing measures in accordance with the procedure set out in the fourth paragraph of Article 311 TFEU as regards the following elements of the system of own resources of the Union: (a) the procedure for calculating and budgeting the annual budgetary balance as set out in Article 8; (b) the provisions and arrangements necessary for controlling and supervising the collection of the own resources referred to in Article 2(1) and any relevant reporting requirements. Article 11 Final and transitional provisions 1. Subject to paragraph 2, Decision 2014/335/EU, Euratom is repealed. Any references to Council Decision 70/243/ECSC, EEC, Euratom (11), to Council Decision 85/257/EEC, Euratom (12), to Council Decision 88/376/EEC, Euratom (13), to Council Decision 94/728/EC, Euratom (14), to Council Decision 2000/597/EC, Euratom (15), to Council Decision 2007/436/EC, Euratom (16) or to Decision 2014/335/EU, Euratom shall be construed as references to this Decision; references to the repealed Decision shall be read in accordance with the correlation table in the Annex to this Decision. 2. Articles 2, 4 and 5 of Decision 94/728/EC, Euratom, Articles 2, 4 and 5 of Decision 2000/597/EC, Euratom, Articles 2, 4 and 5 of Decision 2007/436/EC, Euratom and Articles 2, 4 and 5 of Decision 2014/335/EU, Euratom shall continue to apply to the calculation and adjustment of revenue accruing from the application of the rate of call to the VAT base determined in a uniform manner and limited to between 50 % and 55 % of the GNP or GNI of each Member State, depending on the relevant year, to the calculation of the correction of budgetary imbalances granted to the United Kingdom in the years 1995 to 2020 and to the calculation of the financing of the corrections granted to the United Kingdom by other Members States. 3. Member States shall continue to retain, by way of collection costs, 10 % of the amounts referred to in point (a) of Article 2(1) which should have been made available by the Member States before 28 February 2001 in accordance with the applicable Union rules. 4. Member States shall continue to retain, by way of collection costs, 25 % of the amounts referred to in point (a) of Article 2(1) which should have been made available by the Member States between 1 March 2001 and 28 February 2014 in accordance with the applicable Union rules. 5. Member States shall continue to retain, by way of collection costs, 20 % of the amounts referred to in point (a) of Article 2(1) which should have been made available by the Member States between 1 March 2014 and 28 February 2021 in accordance with the applicable Union rules. 6. For the purposes of this Decision, all monetary amounts shall be expressed in euro. Article 12 Entry into force The Secretary-General of the Council shall notify the Member States of this Decision. Member States shall notify the Secretary-General of the Council without delay of the completion of the procedures for the adoption of this Decision in accordance with their respective constitutional requirements. This Decision shall enter into force on the first day of the first month following receipt of the last of the notifications referred to in the second paragraph. It shall apply from 1 January 2021. Article 13 Addressees This Decision is addressed to the Member States. Done at Brussels, 14 December 2020. For the Council The President M. ROTH (1) Opinion of 16 September 2020 (not yet published in the Official Journal). (2) Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union (OJ L 174, 26.6.2013, p. 1). (3) Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (OJ L 168, 7.6.2014, p. 105). (4) Council Regulation (EEC, Euratom) No 1553/89 of 29 May 1989 on the definitive uniform arrangements for the collection of own resources accruing from value added tax (OJ L 155, 7.6.1989, p. 9). (5) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). (6) European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10). (7) Commission Decision 2005/270/EC of 22 March 2005 establishing the formats relating to the database system pursuant to Directive 94/62/EC of the European Parliament and of the Council on packaging and packaging waste (OJ L 86, 5.4.2005, p. 6). (8) Regulation (EU) 2019/516 of the European Parliament and of the Council of 19 March 2019 on the harmonisation of gross national income at market prices and repealing Council Directive 89/130/EEC, Euratom and Council Regulation (EC, Euratom) No 1287/2003 (GNI Regulation) (OJ L 91, 29.3.2019, p. 19). (9) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (10) Council Regulation (EU, Euratom) No 609/2014 of 26 May 2014 on the methods and procedure for making available the traditional, VAT and GNI-based own resources and on the measures to meet cash requirements (OJ L 168, 7.6.2014, p. 39). (11) Council Decision 70/243/ECSC, EEC, Euratom of 21 April 1970 on the replacement of financial contributions from Member States by the Communities\u2019 own resources (OJ L 94, 28.4.1970, p. 19). (12) Council Decision 85/257/EEC, Euratom of 7 May 1985 on the Communities\u2019 system of own resources (OJ L 128, 14.5.1985, p. 15). (13) Council Decision 88/376/EEC, Euratom of 24 June 1988 on the system of the Communities\u2019 own resources (OJ L 185, 15.7.1988, p. 24). (14) Council Decision 94/728/EC, Euratom of 31 October 1994 on the system of the European Communities\u2019 own resources (OJ L 293, 12.11.1994, p. 9). (15) Council Decision 2000/597/EC, Euratom of 29 September 2000 on the system of the European Communities\u2019 own resources (OJ L 253, 7.10.2000, p. 42). (16) Council Decision 2007/436/EC, Euratom of 7 June 2007 on the system of the European Communities\u2019 own resources (OJ L 163, 23.6.2007, p. 17). ANNEX CORRELATION TABLE Decision 2014/335/EU, Euratom This Decision Article 1 Article 1 Article 2(1)(a) Article 2(1)(a) Article 2(1)(b) Article 2(1)(b) - Article 2(1)(c) Article 2(1)(c) Article 2(1)(d) Article 2(2) - - Article 2(2) Article 2(3) Article 9(2) Article 2(4) Article 2(1)(b) Article 2(5) Article 2(3), first subparagraph and Article 2(4) Article 2(6) Article 2(5) Article 2(7) Article 2(3), second subparagraph and Article 3(4) Article 3(1) Article 3(1) Article 3(2) Article 3(2) and (3) Article 3(3) - Article 3(4) Article 3(4) Article 4 - - Article 4 Article 5 - - Article 5 - Article 6 Article 6 Article 7 Article 7 Article 8 Article 8(1) Article 9(1) Article 8(2) Article 9(3) - Article 9(4) to (9) Article 9 Article 10 Article 10(1) Article 11(1) Article 10(2) Article 11(2) Article 10(3) Article 11(3) Article 10(3), second subparagraph Article 11(4) - Article 11(5) Article 10(4) Article 11(6) Article 11 Article 12 Article 12 - - Article 13", "summary": "The EU\u2019s own resources The EU\u2019s own resources SUMMARY OF: Decision (EU, Euratom) 2020/2053 on the system of own resources of the European Union WHAT IS THE AIM OF THE DECISION? The decision sets out how the EU\u2019s annual budget is financed by: amending some existing rules; updating the own resources ceiling; introducing a new income source (based on plastic packaging waste that is not recycled); allowing the European Commission to borrow on capital markets for the sole purpose of tackling the COVID crisis. KEY POINTS The annual EU budget is financed by EU Member States from the following own resources: traditional income sources: although they used to be the main source of income before 1970, these are now limited to customs duties on imports; value added tax (VAT): a uniform rate of 0.30% is applied to each Member State\u2019s harmonised VAT base, which is capped at 50% of its Gross National Income; Gross National Income (GNI)*: a uniform rate on national GNI to be agreed annually (with annual lump sum reductions for Austria, Denmark, Germany, the Netherlands and Sweden); plastic packaging waste: a uniform rate of \u20ac0.80 per kg is applied to the difference between the quantity of plastic packaging waste generated and recycled (with annual lump sum reductions for 17 Member States whose GNI is below EU average). The maximum size of the annual budget (\u2018own resources ceiling\u2019) is increased from 1.20% to 1.40% of EU GNI for payments* and to 1.46% for commitments* reflecting in particular the departure of the UK from the EU. The following special conditions apply to measures to tackle the COVID-19 crisis through the European Union Recovery Instrument (EURI) \u2014 Regulation (EU) 2020/2094 (see summary): the Commission may borrow up to \u20ac750,000 million (2018 prices) on capital markets; the sum is divided into \u20ac360,000 million for loans and \u20ac390,000 million for expenditure; repayments of the amount borrowed are made from the EU budget, starting before the end of the 2021-2027 multiannual financial framework (Regulation (EU, Euratom) 2020/2093 \u2014 see summary) and fully completed by 31 December 2058 at the latest; the Commission administers the borrowing operations and keeps the European Parliament and the Council regularly informed about its debt management strategy; the ceilings for payments (1.40%) and commitments (1.46%) shall be temporarily increased by 0.6% to cover the liabilities resulting from the borrowing, but not for any other expenditure; the Commission may, as a last resort, ask Member States to make an extra financial contribution if necessary to cover its EURI obligations. The revenues from the own resources are used to finance all elements of EU expenditure in its annual budget and any surplus during one year is carried over to the following one. Member States are responsible for making available the own resources and also for collecting customs duties on behalf of the EU. Member States keep 25% of the traditional income sources to cover their costs. The decision repeals Decision 2014/335/EU, Euratom. FROM WHEN DOES THE DECISION APPLY? It will apply retroactively from 1 January 2021 as soon as it is ratified by all 27 Member States. BACKGROUND The decision needs to be approved/ratified by all 27 Member States to take effect. It is part of a wider financial package that includes: the multiannual financial framework 2021-2027 \u2014 Regulation (EU, Euratom) 2020/2093; the interinstitutional agreement on budgetary discipline, on cooperation in budgetary matters and on sound financial management (see summary) containing a roadmap for introducing new own resources; the Recovery Instrument \u2014 Regulation (EU) 2020/2094. KEY TERMS Gross National Income: gross domestic product plus net receipts from abroad of compensation of employees, property income and net taxes less production subsidies. Payments: expenditure due in the current year from legal commitments made in that year or earlier. Commitments: total cost of legal obligations (contracts, grants agreements/decisions) that may be signed in the current financial year. MAIN DOCUMENT Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, pp. 1-10) RELATED DOCUMENTS Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, pp. 11-22) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433 I , 22.12.2020, pp. 23-27) Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (OJ L 433 I , 22.12.2020, pp. 28-46) last update 23.03.2021"}
{"article": "5.6.2020 EN Official Journal of the European Union L 177/1 REGULATION (EU) 2020/740 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 May 2020 on the labelling of tyres with respect to fuel efficiency and other parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Union is committed to building an Energy Union with a forward\u2010looking climate policy. Fuel efficiency is a crucial element of the Union\u2019s 2030 climate and energy policy framework and is key to moderating energy demand. (2) The Commission has reviewed Regulation (EC) No 1222/2009 of the European Parliament and of the Council (3) and has identified the need to update its provisions to improve its effectiveness. (3) It is appropriate to replace Regulation (EC) No 1222/2009 in order to clarify and update some of its provisions, taking into account technological progress with regard to tyres. (4) The transport sector accounts for a third of the Union\u2019s energy consumption. Road transport was responsible for about 22 % of the Union\u2019s total greenhouse gas emissions in 2015. Tyres, mainly because of their rolling resistance, account for 20 to 30 % of the fuel consumption of vehicles. A reduction in the rolling resistance of tyres would therefore contribute significantly to the fuel efficiency of road transport and thus to the reduction of greenhouse gas emissions and to the decarbonisation of the transport sector. (5) In order to meet the challenge of reducing the CO2 emissions of road transport, it is appropriate that Member States, in cooperation with the Commission, provide for incentives to innovate with regard to fuel\u2010efficient and safe C1 tyres, C2 tyres and C3 tyres. (6) Tyres are characterised by a number of interrelated parameters. Improving one parameter, such as rolling resistance, may have an adverse impact on other parameters, such as wet grip, while improving wet grip performance may have an adverse impact on external rolling noise. Tyre manufacturers should be encouraged to optimise all parameters beyond the current standards. (7) Fuel\u2010efficient tyres can be cost\u2010effective, since the fuel savings that they generate more than offset the increased purchase price resulting from the higher production costs of such tyres. (8) Regulation (EC) No 661/2009 of the European Parliament and of the Council (4) lays down minimum requirements for the rolling resistance of tyres. Technological developments make it possible to reduce the energy losses that are due to tyre rolling resistance significantly beyond those minimum requirements. To reduce the environmental impact of road transport, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase more fuel\u2010efficient tyres by providing them with harmonised information on the rolling resistance parameter. (9) Improving the labelling of tyres will enable consumers to obtain more relevant and more comparable information on fuel efficiency, safety and noise and to take cost\u2010effective and environmentally friendly decisions when purchasing tyres. (10) Traffic noise is a significant nuisance and has a harmful effect on health. Regulation (EC) No 661/2009 lays down minimum requirements for the external rolling noise of tyres. Technological developments make it possible to reduce external rolling noise significantly beyond those minimum requirements. To reduce traffic noise, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase tyres with lower external rolling noise by providing them with harmonised information on the external rolling noise parameter. (11) The provision of harmonised information on external rolling noise also facilitates the implementation of measures to limit traffic noise and contributes to increased awareness of the effect of tyres on traffic noise within the framework of Directive 2002/49/EC of the European Parliament and of the Council (5). (12) Regulation (EC) No 661/2009 also lays down minimum requirements for the wet grip of tyres. Technological developments make it possible to improve wet grip significantly beyond those minimum requirements, and thus to reduce wet braking distances. To improve road safety, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase tyres with higher wet grip performance by providing them with harmonised information on the wet grip parameter. (13) In order to ensure alignment with the international framework, Regulation (EC) No 661/2009 refers to Regulation No 117 of the Economic Commission for Europe of the United Nations (UNECE) (6), which sets out the relevant measurement methods for the rolling resistance, external rolling noise, and wet and snow grip performance of tyres. (14) Information on the performance of tyres that are specifically designed for use in severe snow and ice conditions should be included on the tyre label. Information on snow grip performance should be based on Regulation No 117 of the Economic Commission for Europe of the United Nations (UNECE), in its most up\u2010to\u2010date version applicable to the Union, (UNECE Regulation No 117), and the \u2018Alpine Symbol\u2019 pictogram contained therein should be included on the tyre label of a tyre which satisfies the minimum snow grip index values set out in that Regulation. Information on ice grip performance should, once the standard is formally adopted, be based on ISO standard ISO 19447 and the ice grip pictogram should be included on the tyre label of a tyre which satisfies the minimum ice grip index values set out in that ISO standard. Until adoption of ISO standard ISO 19447, ice grip performance should be assessed against reliable, accurate and reproducible methods, which take into account the generally recognised state of the art. The tyre label of a tyre which satisfies the minimum ice grip performance standards should show the ice grip pictogram set out in Annex I. (15) The abrasion of tyres during use is a significant source of microplastics, which are harmful to the environment and human health. The Commission\u2019s Communication \u2018A European Strategy for Plastics in a Circular Economy\u2019 therefore mentions the need to address the unintentional release of microplastics from tyres, inter alia through information measures such as labelling and through minimum requirements for tyres. Linked to tyre abrasion is the concept of mileage, namely the number of kilometres a tyre will last before it needs to be replaced because of tread wear. In addition to tyre abrasion and tread wear, the lifespan of a tyre depends on a range of factors, such as the wear resistance of the tyre, including the compound, tread pattern and structure, road conditions, maintenance, tyre pressure and driving behaviour. (16) However, a suitable testing method to measure tyre abrasion and mileage is not currently available. Therefore, the Commission should mandate the development of such a testing method, taking into full consideration the state of the art and internationally developed or proposed standards and regulations, as well as the work carried out by industry. (17) Re\u2010treaded tyres constitute a substantial part of the market for heavy\u2010duty vehicle tyres. The re\u2010treading of tyres extends their lifespan and contributes to circular economy objectives, such as waste reduction. Applying labelling requirements to such tyres would bring substantial energy savings. This Regulation should provide for the future inclusion of a suitable testing method to measure the performance of re\u2010treaded tyres, which is not currently available. (18) The energy label provided for under Regulation (EU) 2017/1369 of the European Parliament and of the Council (7), which ranks the energy consumption of products on a scale from \u2018A\u2019 to \u2018G\u2019, is recognised by over 85 % of Union consumers as a clear and transparent information tool and has proven to be effective in promoting more efficient products. The tyre label should be of the same design to the extent possible, while recognising the specificities of tyre parameters. (19) The provision of comparable information on tyre parameters in the form of a standard tyre label is likely to influence purchasing decisions by end-users in favour of more fuel\u2010efficient, longer\u2010lasting, safer and quieter tyres. This, in turn, is likely to encourage tyre manufacturers to optimise tyre parameters, which would pave the way for a more sustainable consumption and production of tyres. (20) The need for greater information on fuel efficiency and other parameters is relevant for all end-users, including purchasers of replacement tyres, purchasers of tyres fitted on new vehicles, and fleet managers and transport undertakings, who cannot easily compare the parameters of different tyre brands in the absence of a labelling and harmonised testing regime. It is therefore appropriate to require that a tyre label be provided for all tyres offered with or fitted on vehicles. (21) Currently, tyre labels are required for tyres for cars (C1 tyres) and vans (C2 tyres) but not for heavy\u2010duty vehicles (C3 tyres). C3 tyres consume more fuel and cover more kilometres per year than C1 tyres or C2 tyres, and therefore the potential to reduce fuel consumption and greenhouse gas emissions from heavy\u2010duty vehicles is significant. Therefore, C3 tyres should be included in the scope of this Regulation. Including C3 tyres fully in the scope of this Regulation is also in line with Regulation (EU) 2018/956 of the European Parliament and of the Council (8), which provides for the monitoring and reporting of CO2 emissions from and fuel consumption of new heavy\u2010duty vehicles, and with Regulation (EU) 2019/1242 of the European Parliament and of the Council (9), which sets CO2 emission performance standards for new heavy\u2010duty vehicles. (22) Many end-users make tyre purchasing decisions without seeing the actual tyre and therefore do not see the tyre label affixed to it. In such situations, end-users should be shown the tyre label before taking their purchasing decisions. The display of a tyre label on tyres at the point of sale, as well as in technical promotional material, should ensure that distributors as well as potential end-users receive harmonised information on the relevant tyre parameters at the time and place of the purchasing decision. (23) Some end-users make tyre purchasing decisions before arriving at the point of sale, or purchase tyres by mail order or on the internet. To ensure that those end-users can also make an informed choice on the basis of harmonised information on, inter alia, fuel efficiency, wet grip and external rolling noise, tyre labels should be displayed in all technical promotional material and visual advertisements for specific tyre types, including where such material is made available on the internet. Where visual advertisements pertain to a tyre family, and not only to a specific tyre type, the tyre label does not have to be shown. (24) Potential end-users should be provided with information explaining each component of the tyre label and its relevance. That information should be provided in all technical promotional material, for example on suppliers\u2019 websites, but should not be required in visual advertisements. Technical promotional material should not be understood to include advertisements via billboards, newspapers, magazines or radio or television broadcasts. (25) Without prejudice to the market surveillance obligations of Member States or to the obligation of suppliers to check product conformity, suppliers should make the requisite product compliance information electronically available in the product database. The information that is relevant to consumers and distributors should be made publicly available in the public part of the product database. That information should be made available as open data so as to give mobile application developers and comparison tools the opportunity to use it. Easy direct access to the public part of the product database should be facilitated by user\u2010oriented tools that are included on the printed tyre label, such as a dynamic quick response code (QR code). (26) The compliance part of the product database should be subject to strict data protection rules. The required specific parts of the technical documentation in the compliance part of the product database should be made available both to market surveillance authorities and to the Commission. Where technical information is too sensitive to include it in the category of technical documentation, market surveillance authorities should have access to that information when necessary in accordance with the duty of cooperation on suppliers or by way of additional parts of the technical documentation uploaded to the product database by suppliers on a voluntary basis. (27) The sale of tyres through internet sales platforms, rather than directly from suppliers, is growing. Therefore, hosting service providers should enable the display of the tyre label and product information sheet provided by the supplier close to the price indication. They should inform the distributor of the obligation to display the tyre label and product information sheet, but should not be responsible for the accuracy or content of that tyre label or product information sheet. The obligations imposed on hosting service providers under this Regulation should remain limited to what is reasonable and should not amount to a general obligation to monitor the information that they store or to actively seek facts or circumstances indicating activities that do not comply with the requirements of this Regulation. However, Article 14(1) of Directive 2000/31/EC of the European Parliament and of the Council (10) requires hosting service providers that wish to benefit from the liability exemption contained in that provision to act expeditiously to remove or disable access to information that they store at the request of recipients of their services where such information does not comply with the requirements of this Regulation, such as those relating to missing, incomplete or incorrect tyre labels or product information sheets. They should do so as soon as they obtain actual knowledge of such information or, as regards claims for damages, as soon as they become aware of such information, for example through specific information provided by a market surveillance authority. Suppliers selling directly to end-users via their own website are subject to the same distance selling obligations as distributors. (28) Rolling resistance, wet grip, external rolling noise and other parameters should be measured in accordance with reliable, accurate and reproducible methods that take into account the generally recognised state\u2010of\u2010the\u2010art measurement and calculation methods. As far as possible, such methods should reflect average consumer behaviour and be robust in order to deter both intentional and unintentional circumvention. Tyre labels should reflect the comparative performance of the tyres in actual use, within the constraints arising from the need for reliable, accurate and reproducible laboratory testing, in order to enable end-users to compare different tyres and to limit testing costs for manufacturers. (29) Where they have sufficient reason to believe that a supplier has not ensured the accuracy of the tyre label and in order to give additional confidence to consumers, national authorities as defined in point (37) of Article 3 of Regulation (EU) 2018/858 of the European Parliament and of the Council (11) should check whether the classes for rolling resistance, wet grip and external rolling noise displayed on the tyre label, as well as the pictograms for other parameters, correspond to the documentation provided by the supplier based on test results and calculations. Such checks may take place during the type\u2010approval process and do not necessarily require the physical testing of the tyre. (30) Compliance by suppliers, wholesalers, dealers and other distributors with the provisions on the labelling of tyres is essential in order to ensure a level playing field in the Union. Member States should therefore monitor such compliance through regular ex\u2010post controls and market surveillance in accordance with Regulation (EU) 2019/1020 of the European Parliament and of the Council (12). (31) In order to facilitate the monitoring of compliance, to provide a useful tool to end-users and to allow alternative ways for distributors to receive product information sheets, tyres should be included in the product database established under Regulation (EU) 2017/1369. That Regulation should therefore be amended accordingly. (32) In order for end-users to have confidence in the tyre label, other labels that mimic the tyre label should not be allowed. For the same reason, other labels, marks, symbols or inscriptions that are likely to mislead or confuse end-users with respect to the parameters covered by the tyre label should not be allowed. (33) The penalties applicable to infringements of this Regulation and of the delegated acts adopted pursuant thereto should be effective, proportionate and dissuasive. (34) In order to promote energy efficiency, climate change mitigation, road safety and environmental protection, Member States should be able to create incentives for the use of energy\u2010efficient and safe tyres. Member States are free to decide on the nature of such incentives. Such incentives should comply with Union State aid rules and should not constitute unjustifiable market barriers. This Regulation does not prejudice the outcome of any State aid procedures that may be undertaken in accordance with Articles 107 and 108 of the Treaty on the Functioning of the European Union (TFEU) in respect of such incentives. (35) In order to amend the content and format of the tyre label, to introduce requirements with respect to re\u2010treaded tyres, tyre abrasion and mileage, and to adapt the Annexes to technological progress, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law\u2010Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (36) Once reliable, accurate and reproducible methods to test and measure tyre abrasion and mileage are available, the Commission should assess the feasibility of adding information on tyre abrasion and mileage to the tyre label. When proposing a delegated act to add tyre abrasion and mileage to the tyre label, the Commission should take that assessment into account, and should collaborate closely with industry, relevant standardisation organisations, such as the European Committee for Standardization (CEN), the United Nations Economic Commission for Europe (UNECE) or the International Organisation for Standardisation (ISO), and representatives of other stakeholders interested in the development of suitable testing methods. Information on tyre abrasion and mileage should be unambiguous and should not negatively affect the clear intelligibility and effectiveness of the tyre label as a whole towards end-users. Such information would also enable end-users to make an informed choice with regard to tyres, their lifespan and the unintentional release of microplastics. This would help protect the environment and at the same time allow end-users to estimate the operating costs of tyres over a longer period. (37) Tyres which were already placed on the market before the date of application of this Regulation should not need to be provided with a new tyre label. (38) The size of the tyre label should remain the same as that set out in Regulation (EC) No 1222/2009. Details regarding snow grip and ice grip, and the QR code, should be included on the tyre label. (39) The Commission should carry out an evaluation of this Regulation. In accordance with paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law\u2010Making, that evaluation should be based on efficiency, effectiveness, relevance, coherence and value added and should provide the basis for impact assessments of options for further action. (40) Since the objective of this Regulation, namely to increase safety, the protection of health, and the economic and environmental efficiency of road transport by providing information to end-users to allow them to choose more fuel\u2010efficient, longer\u2010lasting, safer and quieter tyres, cannot be sufficiently achieved by the Member States because it requires harmonised information for end-users, but can rather, by reason of the need for a harmonised regulatory framework and a level playing field for manufacturers, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). A Regulation remains the appropriate legal instrument as it imposes clear and detailed rules which preclude divergent transposition by Member States and thus ensures a higher degree of harmonisation across the Union. A harmonised regulatory framework at Union rather than at Member State level reduces costs for suppliers, ensures a level playing field and ensures the free movement of goods across the internal market. In accordance with the principle of proportionality, as set out in Article 5 TEU, this Regulation does not go beyond what is necessary in order to achieve that objective. (41) Regulation (EC) No 1222/2009 should therefore be repealed with effect from the date of the application of this Regulation, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes a framework for the provision of harmonised information on tyre parameters through labelling to allow end-users to make an informed choice when purchasing tyres, for the purpose of increasing safety, the protection of health, and the economic and environmental efficiency of road transport, by promoting fuel\u2010efficient, long\u2010lasting and safe tyres with low noise levels. Article 2 Scope 1. This Regulation applies to C1 tyres, C2 tyres and C3 tyres that are placed on the market. Requirements for re\u2010treaded tyres apply once a suitable testing method to measure the performance of such tyres is available in accordance with Article 13. 2. This Regulation does not apply to: (a) off\u2010road professional tyres; (b) tyres designed to be fitted only on vehicles registered for the first time before 1 October 1990; (c) T\u2010type temporary\u2010use spare tyres; (d) tyres whose speed rating is less than 80 km/h; (e) tyres whose nominal rim diameter does not exceed 254 mm or is 635 mm or more; (f) tyres fitted with additional devices to improve traction properties, such as studded tyres; (g) tyres designed only to be fitted on vehicles intended exclusively for racing; (h) second\u2010hand tyres, unless such tyres are imported from a third country. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018C1 tyres\u2019, \u2018C2 tyres\u2019 and \u2018C3 tyres\u2019 means tyres belonging to the respective classes set out in Article 8(1) of Regulation (EC) No 661/2009; (2) \u2018re\u2010treaded tyre\u2019 means a used tyre that is reconditioned by replacing the worn tread with new material; (3) \u2018T\u2010type temporary\u2010use spare tyre\u2019 means a temporary\u2010use spare tyre designed for use at inflation pressures higher than those established for standard and reinforced tyres; (4) \u2018off\u2010road professional tyre\u2019 means a special\u2010use tyre used primarily in severe off\u2010road conditions; (5) \u2018tyre label\u2019 means a graphic diagram, in printed or electronic form, including in the form of a sticker, which includes symbols in order to inform end-users about the performance of a tyre or batch of tyres in relation to the parameters set out in Annex I; (6) \u2018point of sale\u2019 means a location where tyres are displayed or stored and are offered for sale, including car show rooms where tyres that are not fitted on vehicles are offered for sale to end-users; (7) \u2018technical promotional material\u2019 means documentation, in printed or electronic form, that is produced by a supplier to supplement advertising material with the information set out in Annex IV; (8) \u2018product information sheet\u2019 means a standard document containing the information set out in Annex III in printed or electronic form; (9) \u2018technical documentation\u2019 means documentation sufficient to enable market surveillance authorities to assess the accuracy of the tyre label and the product information sheet, including the information set out in point (2) of Annex VII; (10) \u2018product database\u2019 means the product database established pursuant to Article 12 of Regulation (EU) 2017/1369; (11) \u2018distance selling\u2019 means the offer for sale, hire or hire purchase by mail order, catalogue, internet, telemarketing or by any other method by which the potential end-user cannot be expected to see the tyre displayed; (12) \u2018manufacturer\u2019 means a manufacturer as defined in point (8) of Article 3 of Regulation (EU) 2019/1020; (13) \u2018importer\u2019 means an importer as defined in point (9) of Article 3 of Regulation (EU) 2019/1020; (14) \u2018authorised representative\u2019 means a natural or legal person established within the Union who has received a written mandate from a manufacturer to act on the manufacturer\u2019s behalf in relation to specified tasks with regard to the manufacturer\u2019s obligations under the requirements of this Regulation; (15) \u2018supplier\u2019 means a manufacturer established in the Union, an authorised representative of a manufacturer who is not established in the Union, or an importer, who places a product on the Union market; (16) \u2018distributor\u2019 means a natural or legal person in the supply chain, other than the supplier, who makes a product available on the market; (17) \u2018making available on the market\u2019 means making available on the market as defined in point (1) of Article 3 of Regulation (EU) 2019/1020; (18) \u2018placing on the market\u2019 means placing on the market as defined in point (2) of Article 3 of Regulation (EU) 2019/1020; (19) \u2018end-user\u2019 means a consumer, fleet manager or road transport undertaking that buys or is expected to buy a tyre; (20) \u2018parameter\u2019 means a tyre characteristic that has a significant impact on the environment, road safety or health during the use of the tyre, such as tyre abrasion, mileage, rolling resistance, wet grip, external rolling noise, snow grip or ice grip; (21) \u2018tyre type\u2019 means a version of a tyre for which the technical characteristics on the tyre label, the product information sheet and the tyre type identifier are the same for all units of that version; (22) \u2018verification tolerance\u2019 means the maximum admissible deviation between the measurement and calculation results of the verification tests performed by, or on behalf of, market surveillance authorities, and the values of the declared or published parameters, reflecting deviation arising from interlaboratory variation; (23) \u2018tyre type identifier\u2019 means a code, usually alphanumeric, which distinguishes a specific tyre type from other tyre types that have the same trade name or the same trademark as that of the supplier; (24) \u2018equivalent tyre type\u2019 means a tyre type which is placed on the market by the same supplier as another tyre type with a different tyre type identifier and which has the same technical characteristics that are relevant to the tyre label and the same product information sheet. Article 4 Obligations of tyre suppliers 1. Suppliers shall ensure that C1 tyres, C2 tyres and C3 tyres that are placed on the market are accompanied free of charge: (a) for each individual tyre, by a tyre label, in the form of a sticker, that complies with the requirements set out in Annex II, indicating the information and class for each of the parameters set out in Annex I, and by a product information sheet; or (b) for each batch of one or more identical tyres, by a printed tyre label that complies with the requirements set out in Annex II, indicating the information and class for each of the parameters set out in Annex I, and by a product information sheet. 2. For tyres sold or offered for sale by distance selling, suppliers shall ensure that the tyre label is displayed close to the price indication and that the product information sheet can be accessed, including, upon request from the end-user, in printed form. The size of the tyre label shall be such that it is clearly visible and legible and shall be proportionate to the size specified in point 2.1 of Annex II. For tyres sold or offered for sale on the internet, suppliers may make the tyre label for a specific tyre type available in a nested display. 3. Suppliers shall ensure that any visual advertisement for a specific tyre type shows the tyre label. If the visual advertisement indicates the price of that tyre type, the tyre label shall be displayed close to the price indication. For visual advertisements on the internet, suppliers may make the tyre label available in a nested display. 4. Suppliers shall ensure that any technical promotional material concerning a specific tyre type displays the tyre label of that tyre type and includes the information set out in Annex IV. 5. Suppliers shall provide to a relevant national authority as defined in point (37) of Article 3 of Regulation (EU) 2018/858 the values used to determine the related classes and any additional performance information that the supplier declares on the tyre label of tyre types in accordance with Annex I to this Regulation, as well as the tyre label that complies with the requirements set out in Annex II to this Regulation. That information shall be submitted to the relevant national authority on the basis of Article 5(1) and (2) of this Regulation before the placing on the market of the tyre types in question, so that the authority may verify the accuracy of the tyre label. 6. Suppliers shall ensure the accuracy of the tyre labels and product information sheets that they provide. 7. Suppliers may make technical documentation available to the authorities of Member States other than those authorities indicated in paragraph 5 or to relevant national accredited bodies on request. 8. Suppliers shall cooperate with market surveillance authorities and shall take immediate action to remedy any case of non\u2010compliance with this Regulation for which they are responsible, at their own initiative or when required to do so by market surveillance authorities. 9. Suppliers shall not provide or display other labels, marks, symbols or inscriptions that do not comply with this Regulation and that would be likely to mislead or confuse end-users with respect to the parameters set out in Annex I. 10. Suppliers shall not provide or display labels that mimic the tyre label provided for under this Regulation. Article 5 Obligations of tyre suppliers in relation to the product database 1. From 1 May 2021, suppliers shall enter the information set out in Annex VII into the product database before placing on the market a tyre produced after that date. 2. For tyres that are produced between 25 June 2020 and 30 April 2021, the supplier shall enter the information set out in Annex VII into the product database by 30 November 2021. 3. For tyres that are placed on the market before 25 June 2020, the supplier may enter the information set out in Annex VII into the product database. 4. Until the information referred to in paragraphs 1 and 2 has been entered into the product database, the supplier shall make an electronic version of the technical documentation available for inspection within 10 working days of receiving a request from a market surveillance authority. 5. Where type\u2010approval authorities or market surveillance authorities need information other than that set out in Annex VII in order to carry out their tasks under this Regulation, the supplier shall provide them with that information on request. 6. A tyre for which changes are made that are relevant for the tyre label or the product information sheet shall be considered to be a new tyre type. The supplier shall indicate in the product database when it has ceased to place on the market units of a certain tyre type. 7. After the final unit of a tyre type has been placed on the market, the supplier shall keep the information concerning that tyre type in the compliance part of the product database for a period of five years. Article 6 Obligations of tyre distributors 1. Distributors shall ensure that: (a) at the point of sale, tyres bear a tyre label, in the form of a sticker, that complies with the requirements set out in Annex II, provided by the supplier in accordance with point (a) of Article 4(1) in a clearly visible position and legible in its entirety, and that the product information sheet is available, including, upon request, in printed form; or (b) before the sale of a tyre that is part of a batch of one or more identical tyres, a printed tyre label that complies with the requirements set out in Annex II, is shown to the end-user and is clearly displayed close to the tyre at the point of sale, and that the product information sheet is available. 2. Distributors shall ensure that any visual advertisement for a specific tyre type shows the tyre label. If the visual advertisement indicates the price of that tyre type, the tyre label shall be displayed close to the price indication. For visual advertisements on the internet for a specific tyre type, distributors may make the tyre label available in a nested display. 3. Distributors shall ensure that any technical promotional material concerning a specific tyre type displays the tyre label and includes the information set out in Annex IV. 4. Distributors shall ensure that where tyres offered for sale are not visible to the end-user at the time of sale, they provide the end-user with a copy of the tyre label before the sale. 5. Distributors shall ensure that any paper\u2010based distance selling shows the tyre label and that end-users can access the product information sheet through a free access website, and can request a printed copy of the product information sheet. 6. Distributors that use telemarketing\u2010based distance selling shall inform end-users of the classes for each of the parameters on the tyre label, and inform end-users that they can access the tyre label and the product information sheet through a free access website, and by requesting a printed copy. 7. For tyres sold or offered for sale on the internet, distributors shall ensure that the tyre label is displayed close to the price indication and that the product information sheet can be accessed. The size of the tyre label shall be such that it is clearly visible and legible and shall be proportionate to the size specified in point 2.1 of Annex II. Distributors may make the tyre label for a specific tyre type available in a nested display. Article 7 Obligations of vehicle suppliers and vehicle distributors Where end-users intend to acquire a new vehicle, vehicle suppliers and vehicle distributors shall provide, before the sale, those end-users with the tyre label for the tyres offered with or fitted on the vehicle and any relevant technical promotional material, and shall ensure that the product information sheet is available. Article 8 Obligations of hosting service providers Where a service provider as referred to in Article 14 of Directive 2000/31/EC allows the selling of tyres through its internet site, that service provider shall enable the display of the tyre label and the product information sheet provided by the supplier close to the price indication and shall inform the distributor of the obligation to display the tyre label and the product information sheet. Article 9 Testing and measurement methods The information to be provided under Articles 4, 6 and 7 on the parameters indicated on the tyre label shall be obtained in accordance with the testing methods referred to in Annex I and the laboratory alignment procedure referred to in Annex V. Article 10 Verification procedure For each of the parameters set out in Annex I, Member States shall apply the verification procedure set out in Annex VI when assessing the conformity of the declared classes with this Regulation. Article 11 Obligations of Member States 1. Member States shall not impede the placing on the market or putting into service of tyres within their territories, where such tyres comply with this Regulation. 2. Where Member States provide incentives with regard to tyres, such incentives shall target only tyres in class A or B with respect to rolling resistance or wet grip within the meaning of Parts A and B of Annex I, respectively. Taxation and fiscal measures shall not constitute incentives for the purposes of this Regulation. 3. Without prejudice to Regulation (EU) 2019/1020, where the relevant national authority as defined in point (37) of Article 3 of Regulation (EU) 2018/858 has sufficient reason to believe that a supplier has not ensured the accuracy of the tyre label in accordance with Article 4(6) of this Regulation, it shall verify that the classes and any additional performance information declared on the tyre label correspond to the values and to the documentation submitted by the supplier, in accordance with Article 4(5) of this Regulation. 4. In accordance with Regulation (EU) 2019/1020, Member States shall ensure that the national market surveillance authorities establish a system of routine and ad hoc inspections of points of sale for the purposes of ensuring compliance with this Regulation. 5. Member States shall lay down the rules on penalties and enforcement mechanisms applicable to infringements of this Regulation and of the delegated acts adopted pursuant thereto, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 1 May 2021, notify the Commission of those rules and of those measures that have not previously been notified to the Commission, and shall notify it, without delay, of any subsequent amendment affecting them. Article 12 Union market surveillance and control of products entering the Union market 1. Regulation (EU) 2019/1020 shall apply to the tyres covered by this Regulation and the relevant delegated acts adopted pursuant thereto. 2. The Commission shall encourage and support cooperation and the exchange of information on market surveillance relating to the labelling of tyres between the authorities of the Member States that are responsible for market surveillance or are in charge of the control of tyres entering the Union market, and between those authorities and the Commission, in particular by involving the Administrative Cooperation Group for the Labelling of Tyres more closely. 3. Member States\u2019 national market surveillance strategies established pursuant to Article 13 of Regulation (EU) 2019/1020 shall include actions to ensure the effective enforcement of this Regulation. 4. Market surveillance authorities may recover the costs of document inspection and physical product testing from the supplier in cases of non\u2010compliance by the supplier with this Regulation or the relevant delegated acts adopted pursuant thereto. Article 13 Delegated acts 1. The Commission is empowered to adopt delegated acts in accordance with Article 14 in order to amend: (a) Annex II with regard to the content and format of the tyre label; (b) parts D and E of Annex I and Annexes II, III, IV, V, VI and VII, by adapting the values, calculation methods and requirements set out therein to technological progress. 2. By 26 June 2022, the Commission shall adopt delegated acts in accordance with Article 14 in order to supplement this Regulation by introducing new information requirements for re\u2010treaded tyres in the Annexes, provided that a suitable testing method is available. 3. The Commission is also empowered to adopt delegated acts in accordance with Article 14 in order to include parameters or information requirements for tyre abrasion and mileage, as soon as reliable, accurate and reproducible methods to test and measure tyre abrasion and mileage are available for use by European or international standardisation organisations and provided that the following conditions are met: (a) a thorough impact assessment has been carried out by the Commission; and (b) a proper consultation of the relevant stakeholders has been conducted by the Commission. 4. Where appropriate, when preparing delegated acts, the Commission shall test the content and format of tyre labels with representative groups of Union customers to ensure that the tyre labels are clearly understandable, and shall publish the results. Article 14 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 13 shall be conferred on the Commission for a period of five years from 25 June 2020. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five\u2010year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 13 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law\u2010Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 13 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 15 Evaluation and report By 1 June 2025, the Commission shall carry out an evaluation of this Regulation and submit a report to the European Parliament, the Council and the European Economic and Social Committee. That report shall assess how effectively this Regulation and the delegated acts adopted pursuant thereto have led end-users to choose higher\u2010performing tyres, taking into account the impact of this Regulation and the delegated acts adopted pursuant thereto on business, fuel consumption, safety, greenhouse gas emissions, consumer awareness and market surveillance activities. The report shall also assess the costs and benefits of mandatory independent third\u2010party verification of the information provided in the tyre label, taking into account experience gained with regard to the broader framework provided by Regulation (EC) No 661/2009. Article 16 Amendment to Regulation (EU) 2017/1369 In Article 12(2) of Regulation (EU) 2017/1369, point (a) is replaced by the following: \u2018(a) to support market surveillance authorities in carrying out their tasks under this Regulation and the relevant delegated acts, including enforcement thereof, and under Regulation (EU) 2020/740 of the European Parliament and of the Council (*1). Article 17 Repeal of Regulation (EC) No 1222/2009 Regulation (EC) No 1222/2009 is repealed with effect from 1 May 2021. References to the repealed Regulation shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VIII to this Regulation. Article 18 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 May 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 25 May 2020. For the European Parliament The President D. M. SASSOLI For the Council The President A. METELKO-ZGOMBI\u0106 (1) OJ C 62, 15.2.2019, p. 280. (2) Position of the European Parliament of 26 March 2019 (not yet published in the Official Journal) and position of the Council at first reading of 25 February 2020 (OJ C 105, 31.3.2020, p. 1). Position of the European Parliament of 13 May 2020 (not yet published in the Official Journal). (3) Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46). (4) Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1). (5) Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (OJ L 189, 18.7.2002, p. 12). (6) Regulation No 117 of the Economic Commission for Europe of the United Nations (UNECE) \u2013 Uniform provisions concerning the approval of tyres with regard to rolling sound emissions and/or to adhesion on wet surfaces and/or to rolling resistance [2016/1350] (OJ L 218, 12.8.2016, p. 1). (7) Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1). (8) Regulation (EU) 2018/956 of the European Parliament and of the Council of 28 June 2018 on the monitoring and reporting of CO2 emissions from and fuel consumption of new heavy-duty vehicles (OJ L 173, 9.7.2018, p. 1). (9) Regulation (EU) 2019/1242 of the European Parliament and of the Council of 20 June 2019 setting CO2 emission performance standards for new heavy-duty vehicles and amending Regulations (EC) No 595/2009 and (EU) 2018/956 of the European Parliament and of the Council and Council Directive 96/53/EC (OJ L 198, 25.7.2019, p. 202). (10) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). (11) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1). (12) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). (13) OJ L 123, 12.5.2016, p. 1. ANNEX I TESTING, GRADING AND MEASUREMENT OF TYRE PARAMETERS Part A: Fuel efficiency classes and rolling resistance coefficient The fuel efficiency class shall be determined and illustrated on the tyre label on the basis of the rolling resistance coefficient (RRC in N/kN) according to the \u2018A\u2019 to \u2018E\u2019 scale specified in the table below and measured in accordance with Annex 6 to UNECE Regulation No 117 and aligned in accordance with the laboratory alignment procedure set out in Annex V. If a tyre type belongs to more than one tyre class (e.g. C1 and C2), the grading scale used to determine the fuel efficiency class of that tyre type shall be that which is applicable to the highest tyre class (e.g. C2, not C1). C1 tyres C2 tyres C3 tyres Fuel efficiency class RRC in N/kN RRC in N/kN RRC in N/kN A RRC \u2264 6,5 RRC \u2264 5,5 RRC \u2264 4,0 B 6,6 \u2264 RRC \u2264 7,7 5,6 \u2264 RRC \u2264 6,7 4,1 \u2264 RRC \u2264 5,0 C 7,8 \u2264 RRC \u2264 9,0 6,8 \u2264 RRC \u2264 8,0 5,1 \u2264 RRC \u2264 6,0 D 9,1 \u2264 RRC \u2264 10,5 8,1 \u2264 RRC \u2264 9,0 6,1 \u2264 RRC \u2264 7,0 E RRC \u2265 10,6 RRC \u2265 9,1 RRC \u2265 7,1 Part B: Wet grip classes 1. The wet grip class shall be determined and illustrated on the tyre label on the basis of the wet grip index (G) according to the \u2018A\u2019 to \u2018E\u2019 scale specified in the table below, calculated in accordance with point 2 and measured in accordance with Annex 5 to UNECE Regulation No 117. 2. Calculation of wet grip index (G) G = G(T)\u20130,03 where: G(T) = wet grip index of the candidate tyre as measured in one test cycle C1 tyres C2 tyres C3 tyres Wet grip class G G G A 1,55 \u2264 G 1,40 \u2264 G 1,25 \u2264 G B 1,40 \u2264 G \u2264 1,54 1,25 \u2264 G \u2264 1,39 1,10 \u2264 G \u2264 1,24 C 1,25 \u2264 G \u2264 1,39 1,10 \u2264 G \u2264 1,24 0,95 \u2264 G \u2264 1,09 D 1,10 \u2264 G \u2264 1,24 0,95 \u2264 G \u2264 1,09 0,80 \u2264 G \u2264 0,94 E G \u2264 1,09 G \u2264 0,94 G \u2264 0,79 Part C: External rolling noise classes and measured value The external rolling noise measured value (N, in dB(A)) shall be declared in decibels and calculated in accordance with Annex 3 to UNECE Regulation No 117. The external rolling noise class shall be determined and illustrated on the tyre label on the basis of the limit values (LV) set out in Part C of Annex II to Regulation (EC) No 661/2009 as follows: N \u2264 LV \u2013 3 LV \u2013 3 < N \u2264 LV N > LV Part D: Snow grip The snow grip performance shall be tested in accordance with Annex 7 to UNECE Regulation No 117. A tyre which satisfies the minimum snow grip index values set out in UNECE Regulation No 117 shall be classified as a tyre for use in severe snow conditions and the following pictogram shall be included on the tyre label. Part E: Ice grip The ice grip performance shall be tested in accordance with reliable, accurate and reproducible methods, including, where appropriate, international standards, which take into account the generally recognised state of the art. The tyre label of a tyre which satisfies the relevant minimum ice grip index values shall include the following pictogram. ANNEX II CONTENT AND FORMAT OF THE TYRE LABEL 1. Content of the tyre label 1.1. Information to be included in the upper part of the tyre label: 1.2. Information to be included in the bottom part of the tyre label for all tyres other than tyres which satisfy the minimum snow grip index values set out in UNECE Regulation No 117, or the relevant minimum ice grip index values, or both: 1.3. Information to be included in the bottom part of the tyre label for tyres which satisfy the minimum snow grip index values set out in UNECE Regulation No 117: 1.4. Information to be included in the bottom part of the tyre label for tyres which satisfy the relevant minimum ice grip index values: 1.5. Information to be included in the bottom part of the tyre label for tyres which satisfy both the relevant minimum snow grip index values set out in UNECE Regulation No 117 and the minimum ice grip index values: 2. Format of the tyre label 2.1. Format of the upper part of the tyre label: 2.1.1. Format of the bottom part of the tyre label for all tyres other than tyres which satisfy the minimum snow grip index values set out in UNECE Regulation No 117, or the relevant minimum ice grip index values, or both: 2.1.2. Format of the bottom part of the tyre label for tyres which satisfy the minimum snow grip index values set out in UNECE Regulation No 117: 2.1.3. Format of the bottom part of the tyre label for tyres which satisfy the minimum ice grip index values: 2.1.4. Format of the bottom part of the tyre label for tyres which satisfy both the relevant minimum snow grip index values set out in UNECE Regulation No 117 and the minimum ice grip index values: 2.2. For the purposes of point 2.1: (a) Tyre label minimal size: 75 mm wide and 110 mm high. Where the tyre label is printed in a larger format, its content shall nevertheless remain proportionate to the specifications above; (b) Background of the tyre label: 100 % white; (c) Typefaces: Verdana and Calibri; (d) Dimensions and specifications of the elements constituting the tyre label: as specified above; (e) Colour codes, using CMYK \u2013 cyan, magenta, yellow and black, shall fulfil all the following requirements: \u2014 colours of the EU logo as follows: \u2014 background: 100,80,0,0; \u2014 stars: 0,0,100,0; \u2014 colour of the energy logo: 100,80,0,0; \u2014 QR code: 100 % black; \u2014 trade name or trademark of the supplier: 100 % black and in Verdana Bold 7 pt; \u2014 tyre type identifier: 100 % black and in Verdana Regular 7 pt; \u2014 tyre size designation, load\u2010capacity index and speed category symbol: 100 % black and in Verdana Regular 10 pt; \u2014 tyre class: 100 % black and in Verdana Regular 7 pt, aligned to the right; \u2014 letters of the fuel efficiency scale and of the wet grip scale: 100 % white and in Calibri Bold 19 pt; the letters shall be centred on an axis at 4,5 mm from the left side of the arrows; \u2014 CMYK colour codes of arrows for the A to E fuel efficiency scale as follows: \u2014 A\u2010class: 100,0,100,0; \u2014 B\u2010class: 45,0,100,0; \u2014 C\u2010class: 0,0,100,0; \u2014 D\u2010class: 0,30,100,0; \u2014 E\u2010class: 0,100,100,0; \u2014 CMYK colour codes of arrows for the A to E wet grip scale as follows: \u2014 A: 100,60,0,0; \u2014 B: 90,40,0,0; \u2014 C: 65,20,0,0; \u2014 D: 50,10,0,0; \u2014 E: 30,0,0,0; \u2014 internal dividers: weight of 0,5 pts, colour shall be 100 % black; \u2014 letter of the fuel efficiency class: 100 % white and in Calibri Bold 33 pt. Fuel efficiency and wet grip class arrows and the corresponding arrows in the A to E scale shall be positioned in such a way that their tips are aligned. The letter in the fuel efficiency class and in the wet grip class arrow shall be positioned in the centre of the rectangular part of the arrow which shall be 100 % black; \u2014 fuel efficiency pictogram: width 16 mm, height 14 mm, weight 1 pts, colour: 100 % black; \u2014 wet grip pictogram: width 20 mm, height 14 mm, weight 1 pts, colour: 100 % black; \u2014 external rolling noise pictogram: width 24 mm, height 18 mm, weight 1 pts, colour: 100 % black. Number of decibels in the loudspeaker in Verdana Bold 12 pt, the unit \u2018dB\u2019 in Regular 9 pt; the range of external rolling noise classes (A to C) centred under the pictogram, with the letter of the applicable external rolling noise class in Verdana Bold 16 pt and the other letters of the external rolling noise classes in Verdana Regular 10 pt; \u2014 snow grip pictogram: width 15 mm, height 13 mm, weight 1 pts, colour: 100 % black; \u2014 ice grip pictogram: width 15 mm, height 13 mm, weight 1 pts, weight of oblique bars 0,5 pts, colour: 100 % black; \u2014 the number of the regulation shall be 100 % black and in Verdana Regular 6 pt. (1) Regulation No 30 of the Economic Commission for Europe of the United Nations (UN/ECE) \u2013 Uniform provisions concerning the approval of pneumatic tyres for motor vehicles and their trailers (OJ L 201, 30.7.2008, p. 70). (2) Regulation No 54 of the Economic Commission for Europe of the United Nations (UNECE) \u2013 Uniform provisions concerning the approval of pneumatic tyres for commercial vehicles and their trailers (OJ L 183, 11.7.2008, p. 41). ANNEX III PRODUCT INFORMATION SHEET The information in the product information sheet of tyres shall be included in the product brochure or other literature provided with the tyre and shall include the following: (a) the trade name or trademark of the supplier or of the manufacturer if it is not the same as that of the supplier; (b) the tyre type identifier; (c) the tyre size designation, load\u2010capacity index and speed category symbol, as indicated in UNECE Regulation No 30 or in UNECE Regulation No 54 for C1 tyres, C2 tyres and C3 tyres, as applicable; (d) the fuel efficiency class of the tyre in accordance with Annex I; (e) the wet grip class of the tyre in accordance with Annex I; (f) the external rolling noise class and value in decibels in accordance with Annex I; (g) an indication of whether the tyre is a tyre for use in severe snow conditions; (h) an indication of whether the tyre is an ice grip tyre; (i) the date of start of production of the tyre type (two digits for the week and two digits for the year); (j) the date of end of production of the tyre type, once known (two digits for the week and two digits for the year). ANNEX IV INFORMATION PROVIDED IN TECHNICAL PROMOTIONAL MATERIAL 1. Information on tyres included in technical promotional material shall be provided in the following order: (a) the fuel efficiency class (letter \u2018A\u2019 to \u2018E\u2019); (b) the wet grip class (letter \u2018A\u2019 to \u2018E\u2019); (c) the external rolling noise class and measured value in dB; (d) an indication of whether the tyre is a tyre for use in severe snow conditions; (e) an indication of whether the tyre is an ice grip tyre. 2. The information referred to in point 1 shall meet the following requirements: (a) it shall be easy to read; (b) it shall be easy to understand; (c) if within a tyre family tyre types are classified differently depending on dimension or other characteristics, the range between the lowest performing and highest performing tyre types shall be stated. 3. Suppliers shall also make the following available on their websites: (a) a link to the relevant Commission webpage dedicated to this Regulation; (b) an explanation of the pictograms printed on the tyre label; (c) a statement highlighting the fact that actual fuel savings and road safety depend heavily on the behaviour of drivers, and in particular on the following: \u2014 eco\u2010driving can significantly reduce fuel consumption; \u2014 tyre pressure needs to be regularly checked to optimise fuel efficiency and wet grip; \u2014 stopping distances must always be respected. 4. Suppliers and distributors shall also, where relevant, make available on their websites a statement highlighting the fact that ice grip tyres are specifically designed for road surfaces covered with ice and compact snow, and should only be used in very severe climate conditions (e.g. cold temperatures) and that using ice grip tyres in less severe climate conditions (e.g. wet conditions or warmer temperatures) could result in sub\u2010optimal performance, in particular for wet grip, handling and wear. ANNEX V LABORATORY ALIGNMENT PROCEDURE FOR THE MEASUREMENT OF ROLLING RESISTANCE 1. Definitions For the purposes of the laboratory alignment procedure for the measurement of rolling resistance, the following definitions apply: (1) \u2018reference laboratory\u2019 means a laboratory that is part of the network of laboratories, the names of which have been published in the Official Journal of the European Union for the purpose of the laboratory alignment procedure, and that is able to achieve the accuracy of test results determined in Section 3 with its reference machine; (2) \u2018candidate laboratory\u2019 means a laboratory participating in the laboratory alignment procedure that is not a reference laboratory; (3) \u2018alignment tyre\u2019 means a tyre that is tested for the purpose of performing the laboratory alignment procedure; (4) \u2018alignment tyre set\u2019 means a set of five or more alignment tyres for the alignment of one single machine; (5) \u2018assigned value\u2019 means a theoretical value of the rolling resistance coefficient (RRC) of one alignment tyre as measured by a theoretical laboratory which is representative of the network of reference laboratories that is used for the laboratory alignment procedure; (6) \u2018machine\u2019 means every tyre testing spindle in one specific measurement method; for example, two spindles acting on the same drum shall not be considered as one machine. 2. General provisions 2.1. Principle The measured (m) rolling resistance coefficient obtained in a reference laboratory (l), (RRCm,l ), shall be aligned to the assigned values of the network of reference laboratories. The measured (m) rolling resistance coefficient obtained by a machine in a candidate laboratory (c), (RRCm,c ), shall be aligned through one reference laboratory of the network of its choice. 2.2. Tyre selection requirements Alignment tyre sets shall be selected for the laboratory alignment procedure in accordance with the following criteria. One alignment tyre set shall be selected for C1 tyres and C2 tyres together, and one set for C3 tyres: (a) the alignment tyre set shall be selected so as to cover the range of different RRCs of C1 tyres and C2 tyres together, or of C3 tyres; in any event, the difference between the highest RRCm of the alignment tyre set, and the lowest RRCm of the alignment tyre set shall be, before and after alignment, at least equal to: (i) 3 N/kN for C1 tyres and C2 tyres; and (ii) 2 N/kN for C3 tyres; (b) the RRCm in the candidate or reference laboratories (RRCm,c or RRCm,l ) based on declared RRC values of each alignment tyre of the alignment tyre set shall be distributed evenly; (c) load index values shall adequately cover the range of the tyres to be tested, ensuring that the rolling resistance values also cover the range of the tyres to be tested. Each alignment tyre shall be checked prior to use and shall be replaced when: (a) the alignment tyre shows a condition which makes it unusable for further tests; or (b) there are deviations of RRCm,c or RRCm,l greater than 1,5 % relative to earlier measurements after correction for any machine drift. 2.3. Measurement method The reference laboratory shall measure each alignment tyre four times and retain the three last results for further analysis, in accordance with paragraph 4 of Annex 6 to UNECE Regulation No 117 and under the conditions set out in paragraph 3 of Annex 6 to UNECE Regulation No 117. The candidate laboratory shall measure each alignment tyre (n + 1) times, with n being specified in Section 5 of this Annex and retain the n last results for further analysis, in accordance with paragraph 4 of Annex 6 to UNECE Regulation No 117 and applying the conditions set out in paragraph 3 of Annex 6 to UNECE Regulation No 117. Each time an alignment tyre is measured, the tyre/wheel assembly shall be removed from the machine and the entire test procedure referred to in paragraph 4 of Annex 6 to UNECE Regulation No 117 shall be followed again from the start. The candidate or reference laboratory shall calculate: (a) the measured value of each alignment tyre for each measurement as specified in paragraphs 6.2 and 6.3 of Annex 6 to UNECE Regulation No 117 (i.e. corrected for a temperature of 25 \u00b0C and a drum diameter of 2 m); (b) the mean value of the three last measured values of each alignment tyre (in the case of reference laboratories) or the mean value of the n last measured values of each alignment tyre (in the case of candidate laboratories); and (c) the standard deviation (\u03c3m ) as follows: where: i is the counter from 1 to p for the alignment tyres; j is the counter from 2 to n + 1 for the n last repetitions of each measurement of a given alignment tyre; n + 1 is the number of repetitions of tyre measurements (n + 1 = 4 for reference laboratories and n + 1 \u2265 4 for candidate laboratories); p is the number of alignment tyres (p \u2265 5). 2.4. Data formats to be used for the computations and results The measured RRC values corrected from drum diameter and temperature shall be rounded to two decimal places. Then the computations shall be made with all digits: there shall be no further rounding except on the final alignment equations. All standard deviation values shall be displayed to three decimal places. All RRC values will be displayed to two decimal places. All alignment coefficients (A1 l , B1 l , A2 c and B2 c ) shall be rounded and displayed to four decimal places. 3. Requirements applicable to the reference laboratories and determination of the assigned values The assigned values of each alignment tyre shall be determined by a network of reference laboratories. Every second year the network shall assess the stability and validity of the assigned values. Each reference laboratory participating in the network shall comply with the specifications of Annex 6 to UNECE Regulation No 117 and have a standard deviation (\u03c3m ) as follows: (a) not greater than 0,05 N/kN for C1 tyres and C2 tyres; and (b) not greater than 0,05 N/kN for C3 tyres. The alignment tyre sets that have been selected in accordance with Section 2.2 shall be measured in accordance with Section 2.3 by each reference laboratory of the network. The assigned value of each alignment tyre is the average of the measured values given by the reference laboratories of the network for this alignment tyre. 4. Procedure for the alignment of a reference laboratory to the assigned values Each reference laboratory (l) shall align itself to each new set of assigned values and always after any significant machine change or any drift in machine control tyre monitoring data. The alignment shall use a linear regression technique on all individual data. The regression coefficients, A1 l and B1 l , shall be calculated as follows: RRC = A1 l \u00d7 RRCm,l + B1 l where: RRC l is the assigned value of the rolling resistance coefficient; RRCm, l is the individual measured value of the rolling resistance coefficient by the reference laboratory \u2018l\u2019 (including temperature and drum diameter corrections). 5. Requirements applicable to candidate laboratories Candidate laboratories shall repeat the alignment procedure at least once every second year for every machine and always after any significant machine change or any drift in machine control tyre monitoring data. A common set of five different tyres that have been selected in accordance with Section 2.2 shall be measured in accordance with Section 2.3 first by the candidate laboratory and then by one reference laboratory. More than five alignment tyres may be tested at the request of the candidate laboratory. The candidate laboratory shall provide the alignment tyre set to the selected reference laboratory. The candidate laboratory (c) shall comply with the specifications of Annex 6 to UNECE Regulation No 117 and preferably have standard deviations (\u03c3m ) as follows: (a) not greater than 0,075 N/kN for C1 tyres and C2 tyres; and (b) not greater than 0,06 N/kN for C3 tyres. If the standard deviation (\u03c3m ) of the candidate laboratory is higher than those values after four measurements, the last three being used for the computations, then the number n + 1 of measurement repetitions shall be increased as follows for the entire batch: n + 1 = 1 + (\u03c3m /\u03b3)2, rounded up to the nearest higher integer value where: \u03b3 = 0,043 N/kN for C1 tyres and C2 tyres; \u03b3 = 0,035 N/kN for C3 tyres. 6. Procedure for the alignment of a candidate laboratory One reference laboratory (l) of the network shall calculate the linear regression function on all individual data of the candidate laboratory (c). The regression coefficients, A2 c and B2 c , shall be calculated as follows: RRCm,l = A2 c \u00d7 RRCm,c + B2 c where: RRCm,l is the individual measured value of the rolling resistance coefficient by the reference laboratory (l) (including temperature and drum diameter corrections); RRCm,c is the individual measured value of the rolling resistance coefficient by the candidate laboratory (c) (including temperature and drum diameter corrections) If the coefficient of determination R2 is lower than 0,97, the candidate laboratory shall not be aligned. The aligned RRC of tyres tested by the candidate laboratory shall be calculated as follows: RRC = (A1 l \u00d7 A2 c ) \u00d7 RRCm,c + (A1 l \u00d7 B2 c + B1 l ) ANNEX VI VERIFICATION PROCEDURE The conformity with this Regulation of the declared fuel efficiency, wet grip and external rolling noise classes, as well as the declared values, and any additional performance information on the tyre label, shall be assessed for each tyre type or each grouping of tyres as determined by the supplier, according to one of the following procedures: 1. A single tyre or tyre set is tested first. If the measured values meet the declared classes or the declared external rolling noise value within the verification tolerances referred to in the table below, the tyre label shall be considered to comply with this Regulation. If the measured values do not meet the declared classes or the declared external rolling noise value within the verification tolerances referred to in the table below, three additional tyres or tyre sets are to be tested; the average measurement value stemming from the three additional tyres or tyre sets tested is to be used to verify the declared information, taking into account the verification tolerances referred to in the table below. 2. Where the classes or values on the tyre label are derived from type\u2010approval test results obtained in accordance with Regulation (EC) No 661/2009, or UNECE Regulation No 117, Member States may use measurement data obtained from the conformity of production tests on tyres that were carried out under the type\u2010approval procedure established by Regulation (EU) 2018/858. Assessments of the measurement data obtained from the conformity of production tests shall take into account the verification tolerances referred to in the table below. Measured parameter Verification tolerances RRC (fuel efficiency) The aligned measured value shall not be greater than the upper limit (the highest RRC) of the declared class by more than 0,3 N/kN. External rolling noise The measured value shall not be greater than the declared value of N by more than 1 dB(A). Wet grip The measured value G(T) shall not be lower than the lower limit (the lowest value of G) of the declared class. Snow grip The measured value shall not be lower than the minimum snow grip index. Ice grip The measured value shall not be lower than the minimum ice grip index. ANNEX VII INFORMATION TO BE ENTERED INTO THE PRODUCT DATABASE BY THE SUPPLIER 1. Information to be entered into the public part of the product database: (a) the trade name or trademark, address, contact details and other legal identification of the supplier; (b) the tyre type identifier; (c) the tyre label in electronic format; (d) the class(es) and other parameters of the tyre label; and (e) the parameters of the product information sheet in electronic format. 2. Information to be entered into the compliance part of the product database: (a) the tyre type identifier of all equivalent tyre types that are already placed on the market; (b) a general description of the tyre type, including its dimensions, load index and speed rating, sufficient for it to be unequivocally and easily identified; (c) protocols of the testing, grading and measurement of the tyre parameters set out in Annex I; (d) specific precautions, if any, that shall be taken when the tyre type is assembled, installed, maintained or tested; (e) the measured technical parameters of the tyre type, where relevant; and (f) the calculations performed with the measured technical parameters. ANNEX VIII CORRELATION TABLE Regulation (EC) No 1222/2009 This Regulation Article 1(1) \u2014 Article 1(2) Article 1 Article 2(1) Article 2(1) Article 2(2) Article 2(2) Article 3, point (1) Article 3, point (1) \u2014 Article 3, point (2) Article 3, point (2) Article 3, point (3) \u2014 Article 3, point (4) \u2014 Article 3, point (5) Article 3, point (3) Article 3, point (6) Article 3, point (4) Article 3, point (7) \u2014 Article 3, point (8) Article 3, point (5) Article 3, point (9) \u2014 Article 3, point (10) \u2014 Article 3, point (11) Article 3, point (6) Article 3, point (12) Article 3, point (7) Article 3, point (13) Article 3, point (8) Article 3, point (14) Article 3, point (9) Article 3, point (15) Article 3, point (10) Article 3, point (16) Article 3, point (11) Article 3, point (17) \u2014 Article 3, point (18) Article 3, point (12) Article 3, point (19) Article 3, point (13) Article 3, point (20) \u2014 Article 3, point (21) \u2014 Article 3, point (22) \u2014 Article 3, point (23) \u2014 Article 3, point (24) Article 4 Article 4 Article 4(1) Article 4(1) Article 4(1), point (a) Article 4(1), point (a) Article 4(1), point (b) Article 4(1), point (b) Article 4(2) \u2014 \u2014 Article 4(2) \u2014 Article 4(3) Article 4(3) Article 4(4) Article 4(4) Article 4(5) \u2014 Article 4(6) \u2014 Article 4(7) \u2014 Article 4(8) \u2014 Article 4(9) \u2014 Article 4(10) \u2014 Article 5 Article 5(1) Article 6(1) Article 5(1), point (a) Article 6(1), point (a) Article 5(1), point (b) Article 6(1), point (b) \u2014 Article 6(2) \u2014 Article 6(3) Article 5(2) Article 6(4) Article 5(3) \u2014 \u2014 Article 6(5) \u2014 Article 6(6) \u2014 Article 6(7) Article 6 Article 7 \u2014 Article 8 Article 7 Article 9 Article 8 Article 10 Article 9(1) Article 11(1) Article 9(2) Article 11(1) Article 9(2), 2nd sentence Article 4(5) Article 10 Article 11(2) \u2014 Article 11(3) Article 11, point (a) \u2014 Article 11, point (b) \u2014 Article 11, point (c) Article 13(1), point (b) Article 12 Article 11(4) \u2014 Article 11(5) \u2014 Article 12 \u2014 Article 13 \u2014 Article 13(1) \u2014 Article 13(2) \u2014 Article 13(3) \u2014 Article 13(4) \u2014 Article 14 Article 13 \u2014 Article 14 \u2014 \u2014 Article 15 Article 15 \u2014 \u2014 Article 16 \u2014 Article 17 Article 16 Article 18 Annex I Annex I Annex II Annex II \u2014 Annex III Annex III Annex IV Annex IV Annex VI Annex IVa Annex V Annex V \u2014 \u2014 Annex VII \u2014 Annex VIII", "summary": "Information on tyre fuel efficiency, braking capacity and noise levels Information on tyre fuel efficiency, braking capacity and noise levels SUMMARY OF: Regulation (EU) 2020/740 on the labelling of tyres with respect to fuel efficiency and other parameters WHAT IS THE AIM OF THE REGULATION? It aims to give consumers more information when choosing new tyres for their vehicles. It makes labels about a tyre\u2019s characteristics and performance, in snow and ice for instance, more visible and informative. This will help end-users* take into account features such as safety, health protection and economic and environmental efficiency. The legislation is designed to promote fuel-efficient, long-lasting and safe tyres with low noise levels. It amends Regulation (EU) 2017/1369 (see summary). KEY POINTS The regulation: applies to tyres for passenger cars (C1 tyres), buses and coaches, light and heavy goods vehicles, and light and heavy trailers (C2 and C3 tyres), as well as to retreads* once a suitable performance test is available; does not apply to certain specalised categories of tyre, such as those for off-road professional use, to vehicles first registered before 1 October 1990 or to second-hand tyres, unless imported from a non-EU country. Tyre suppliers must: attach a sticker label to individual tyres and a printed label to a batch of tyres, containing the information set out in Annexes I and II, and provide a product information sheet containing the details specified in Annex III; make the tyre label visible, preferably close to the price, in advertisements and distance selling or internet sales; ensure the tyre labels and product information sheets are accurate; cooperate with market surveillance authorities, which may carry out routine and ad hoc inspections, and act immediately if any infringements are discovered; provide their national authorities, via a product database, with technical details of the tyres and their performance before they are offered for sale, enabling authorities to check the accuracy of the tyre labels \u2014 the information will have to be supplied from 1 May 2021 (and by 30 November 2021 for tyres produced between 25 June 2020 and 30 April 2021); not provide or display labels, marks, symbols or inscriptions that do not comply with the regulation. Tyre distributors must: attach a sticker label to individual tyres and a printed label to a batch of tyres at the point of sale, containing the information required; ensure the tyre label is displayed close to the price on any technical promotional material, paper-based distances sales, and advertisements and internet sales; provide customers with a copy of the tyre label before a sale, if the tyres are not visible; inform customers where they can access the product information sheet. Suppliers and distributors of new vehicles must provide customers with the tyre label, product information sheet and any relevant technical promotional material before a purchase is made. Internet service providers must ensure that suppliers selling tyres on their sites display the necessary label as well as the information sheet. National authorities must: allow the sale and use of tyres that comply with the legislation; verify the accuracy of the information on the tyre labels; lay down penalty and enforcement rules for any infringements. The European Commission: encourages and supports cooperation and information exchange between market surveillance authorities; may adopt delegated acts to amend some of the annexes to take account of technical improvements; submits a report evaluating the regulation to the European Parliament, the Council and the European Economic and Social Committee by 1 June 2025. Repeal Regulation (EU) 2020/740 repeals the tyre-labelling Regulation (EC) No 1222/2009 (see summary). FROM WHEN DOES THE REGULATION APPLY? It applies from 1 May 2021. BACKGROUND The tyre-labelling system aims to reduce greenhouse gas emissions and noise pollution and improve road safety. Tyres account for 20-30% of a vehicle\u2019s fuel consumption. Reducing their rolling resistance helps cut emissions and increase savings for drivers through lower fuel consumption. For more information, see: Tyres \u2014 Energy label (European Commission). KEY TERMS End-user: an individual consumer, fleet manager or road transport company. Retread: a reconditioned tyre where the worn tread is replaced with new material. MAIN DOCUMENT Regulation (EU) 2020/740 of the European Parliament and of the Council of 25 May 2020 on the labelling of tyres with respect to fuel efficiency and other parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009 (OJ L 177, 5.6.2020, pp. 1-31) Successive amendments to Regulation (EU) 2020/740 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1-44) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, pp. 1-218) Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, pp. 1-23) Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, pp. 46-58) See consolidated version. Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, pp. 1-24) See consolidated version. last update 02.12.2020"}
{"article": "2.7.2021 EN Official Journal of the European Union L 234/1 REGULATION (EU) 2021/1077 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 June 2021 establishing, as part of the Integrated Border Management Fund, the instrument for financial support for customs control equipment THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33, 114 and 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The 2 140 customs offices situated at the external borders of the Union need to be properly equipped to ensure the efficient and effective operation of the customs union. The need for adequate customs controls with equivalent results is ever more pressing, not only because of the traditional function of customs, which is to collect revenue, but also increasingly because of the need to significantly reinforce the control of goods entering and exiting the Union\u2019s external borders in order to ensure both safety and security. However, at the same time, such controls on the movement of goods across the external borders should not impair but rather facilitate legitimate trade with third countries. (2) The customs union is one of the cornerstones of the Union, which is one of the largest trading blocks in the world. Since the customs union is essential for the proper functioning of the internal market, and for businesses and citizens to benefit from it, continuous steps to strengthen the customs union are needed. (3) There is currently an imbalance in the performance of customs control by Member States. This imbalance is due to differences between Member States both in terms of their geographic features, and their capacities and resources. The ability of Member States to react to challenges generated by the constantly evolving global business models and supply chains depends not only on the human component but also on the availability, and on the proper functioning, of modern and reliable customs control equipment. Challenges, such as the surge in e-commerce, increasing digitalisation and the need to improve resilience to cyber-attacks, will also increase demand for effective customs controls. The provision of equivalent customs control equipment is therefore an important element in addressing that current imbalance. It will improve equivalence in the performance of customs controls across the Member States and thereby contribute to preventing the diversion of flows of goods towards the weakest points in the customs control system, often referred to as \u2018import point shopping\u2019. Consequently, goods entering the customs territory of the Union should be subject to risk-based controls in accordance with Regulation (EU) No 952/2013 of the European Parliament and of the Council (3) (\u2018the Union Customs Code\u2019). (4) Member States have repeatedly expressed the need for financial support, and have requested an in-depth analysis of the equipment needed. In its conclusions on customs funding on 23 March 2017, the Council invited the Commission to evaluate the possibility of funding technical equipment needs from future Commission financial programmes and improve coordination and cooperation between customs authorities and other law enforcement authorities for funding purposes. (5) Under the Union Customs Code, customs controls are to be understood not only as the enforcement of customs legislation but also as the enforcement of other legislation governing the entry, exit, transit, movement, storage and end-use of goods moved between the customs territory of the Union and countries or territories outside the customs territory of the Union, and the presence and movement within the customs territory of the Union of non-Union goods and goods placed under the end-use procedure. That other legislation empowers customs authorities to carry out specific control tasks and contains provisions on taxation, in particular as regards excise duties and value added tax, on the external aspects of the internal market, on the common trade policy and other common Union policies having a bearing on trade, on the overall supply chain security and on the protection of the financial and economic interests of the Union and its Member States. (6) Supporting the achievement of an adequate and equivalent level of customs control results at the Union\u2019s external borders enables the benefits of the customs union to be maximised, thereby giving additional support to customs authorities acting as one to protect the interests of the Union. A dedicated Union fund for customs control equipment to correct current imbalances would contribute to the overall cohesion between Member States. That dedicated fund would take account of the different needs experienced at the different types of border, namely those at sea and on other waterways, in the air, and on land, including rail and road borders, as well as postal hubs. In view of the challenges facing the world, in particular the continued need to protect the financial and economic interests of the Union and its Member States while easing the flow of legitimate trade, the availability of modern and reliable control equipment at the external borders is indispensable. (7) It is therefore appropriate to establish a new Instrument for financial support for customs control equipment intended to be used at all types of borders. The Instrument should support the customs union and the work of the customs authorities, in particular helping them to protect the Union\u2019s financial and economic interests, to ensure security and safety within the Union and to protect the Union from unfair and illegal trade, such as counterfeiting of goods, while facilitating legitimate business activity. It should contribute to adequate and equivalent results of customs controls. Furthermore, customs control equipment financed under this Instrument should support the implementation of the customs risk management framework as referred to in the Union Customs Code. This objective should be achieved through the transparent purchase, maintenance and upgrading of relevant, state-of-the-art and reliable customs control equipment, taking due account of the protection of data, cyber-resilience, and safety and environmental considerations, including the environmentally friendly disposal of the replaced equipment. (8) Customs authorities of the Member States have been taking on an increasing number of responsibilities which are carried out at the external border and which often extend into the security field. It is therefore important to provide Union financial support to the Member States in order to enable them to ensure equivalence in the performance of border control and customs control at the external borders of the Union. It is equally important to promote, at Union borders, as regards controls of goods and controls of persons, inter-agency cooperation among the national authorities in each Member State that are responsible for border control or for other tasks carried out at the border, with a view to maximising Union added value in the field of border management and customs controls. (9) It is therefore necessary to establish an Integrated Border Management Fund (\u2018the Fund\u2019). (10) Due to the legal particularities of Title V of the Treaty on the Functioning of the European Union (TFEU), as well as the different applicable legal bases regarding the policies on external borders and on customs control, it is not legally possible to establish the Fund as a single instrument. (11) The Fund should therefore be established as a comprehensive framework for Union financial support in the field of border management, consisting of the Instrument for financial support for customs control equipment (\u2018the Instrument\u2019) established by this Regulation and the Instrument for Financial Support for Border Management and Visa Policy established by the Regulation of the European Parliament and of the Council establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy. (12) In view of the importance of tackling climate change and in line with the Union\u2019s commitments to implement the Paris Agreement under the United Nations Framework Convention on Climate Change (4), and to achieve the United Nations Sustainable Development Goals of the 2030 Agenda for Sustainable Development adopted on 25 September 2015, the actions under this Regulation should contribute to the achievement of the Union\u2019s goal of spending at least 30 % of the total amount of the Union budget on supporting climate objectives and of the Union\u2019s ambition to spend 7,5 % of the annual Union budget on biodiversity in 2024 and 10 % both in 2026 and in 2027, while taking into account the existing overlaps between climate and biodiversity goals. (13) This Regulation lays down a financial envelope for the entire duration of the Instrument, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (5), for the European Parliament and the Council during the annual budgetary procedure. It should be possible for that financial envelope to cover necessary and duly justified expenses for activities for managing the Instrument and evaluating its performance, insofar as those activities are related to the general and specific objectives of the Instrument. (14) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (6) (the \u2018Financial Regulation\u2019) applies to this Instrument. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (15) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. These rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. Funding under this Instrument should be subject to the principles referred to in the Financial Regulation and should ensure the optimal use of financial resources in achieving its objectives. (16) Regulation (EU) 2021/444 of the European Parliament and of the Council (7) establishes the Customs programme for cooperation in the field of customs (the \u2018Customs programme\u2019) to support the customs union and customs authorities. In order to preserve the coherence and horizontal coordination of cooperation actions relating to customs and customs control equipment, it is appropriate to implement such actions under a single legal act, namely, the Customs programme, containing a single set of rules. Therefore, only the purchase, maintenance and upgrade of the eligible customs control equipment should be supported under this Instrument, while all other related actions, such as cooperation actions for the assessment of needs or training relating to the equipment concerned, should be supported by the Customs programme. (17) In addition, and where appropriate, the Instrument should also support the purchase or upgrade of customs control equipment for testing new pieces of equipment or new functionalities for existing pieces of equipment in operational conditions before Member States start large-scale purchases of such new equipment. Testing in operational conditions should follow up in particular on the outcomes of research of customs control equipment in the framework of Regulation (EU) 2021/695 of the European Parliament and of the Council (8). The Commission should encourage the joint procurement and joint testing of customs control equipment by two or more Member States, making use of the cooperation tools under the Customs programme. (18) Most customs control equipment may be equally or incidentally fit for controls of compliance with other Union law, such as that on border management, visa or police cooperation. The Fund has therefore been conceived as two complementary instruments for the purchase of equipment, each with a distinct but complementary scope. On the one hand, the Instrument for Financial Support for Border Management and Visa Policy will only financially support the costs of equipment of which the primary aim or effect is integrated border management, but will also allow that equipment to be used for additional purposes, such as customs controls. On the other hand, the instrument for financial support for customs control equipment established by this Regulation will only financially support the costs of equipment of which the primary aim or effect is customs controls but will also allow that equipment to be used for additional purposes, such as border controls and security. This distribution of roles between the two instruments will foster inter-agency cooperation, as referred to in point (e) of Article 3(1) of Regulation (EU) 2019/1896 of the European Parliament and of the Council (9), as a component of the European integrated border management approach, thereby enabling customs and border authorities to work together and maximising the impact of the Union budget through co-sharing and inter-operability of control equipment. The sharing of equipment between customs and other border authorities should not be systematic. (19) In accordance with Article 193(2) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. While in such cases the costs incurred prior to the date of submission of the grant application would in principle not be eligible, this should exceptionally be possible in view of the delayed entry into force of this Regulation as compared to the beginning of the multiannual financial framework 2021-2027. In order to allow implementation from the beginning of the multiannual financial framework 2021-2027 and to avoid any delay in Union support which could be prejudicial to the Union\u2019s interest in being properly equipped to ensure the efficient and effective operation of the customs union, it should be possible, for a limited period of time at the beginning of the multiannual financial framework 2021-2027, to provide in the financing decision for costs incurred in respect of actions supported under this Regulation which have already begun to be considered eligible as of 1 January 2021, even if those actions were implemented and those costs were incurred before the grant application was submitted. (20) By way of derogation from the Financial Regulation, funding of an action by several Union programmes or instruments should be possible in order to allow and support, where appropriate, cooperation and interoperability across domains. However, in accordance with the principle of prohibition of double funding established by the Financial Regulation, in such cases, the contributions are not permitted to cover the same costs. If a Member State has already been awarded or has received contributions from another Union programme or support from a Union fund for the acquisition of the same equipment, that contribution or support should be communicated to the Commission, in accordance with Article 191 of the Financial Regulation. (21) Any funding in excess of the co-financing rate ceiling should be granted only in duly justified cases, which might include cases of joint procurement and of joint testing of customs control equipment by two or more Member States. (22) In view of the rapid evolution of technologies, threats and customs priorities, work programmes should not extend over longer periods. At the same time, annual work programmes would not be necessary for the implementation of the Instrument and would increase the administrative burden on the Commission and Member States. Against that backdrop, work programmes should in principle cover more than one budgetary year, but not more than three. (23) In order to ensure uniform conditions for the implementation of the work programmes under this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (10). (24) Although central implementation is indispensable if the specific objective of ensuring equivalent results of customs controls is to be achieved, the technical nature of this Instrument means that preparatory work is required at technical level. Therefore, implementation should be supported by assessments of needs. Those assessments of needs are dependent on national expertise and experience through the involvement of customs authorities. They should be based on a clear methodology that includes a minimum number of steps ensuring the collection of the relevant information. The Commission should use this information to determine the allocation of the funds to Member States, taking into consideration in particular the volume of trade, the relevant risks and the administrative capacity of the customs authorities to use and maintain the equipment, with a view to achieving the most efficient use of the customs control equipment financed under the Instrument. To contribute to budgetary discipline, the conditions for the prioritisation of grants should be clearly defined and based on such an assessment of needs. (25) To ensure regular monitoring and reporting, a proper framework for monitoring the results achieved by the Instrument and actions under it should be put in place. Such monitoring and reporting should be based on quantitative and qualitative indicators for measuring the effects of the actions under the Instrument. Reporting requirements should include a requirement to provide the Commission with information on customs control equipment where the cost of a piece of customs control equipment exceeds EUR 10 000 exclusive of taxes. That information should be distinguished from the information required to be provided to the general public and to the media in order to promote the actions and the results of the Instrument. (26) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (11), the Instrument should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating, in a comparable and complete manner, the effects of the Instrument on the ground. The interim and final evaluations, which should be performed no later than four years after the start of the implementation and the completion of the Instrument, respectively, should contribute to the efficient decision-making process concerning financial support for customs control equipment under the next multiannual financial frameworks. It is therefore of the utmost importance that the interim and final evaluations include satisfactory and sufficient information and that those evaluations are delivered in due time. The Commission should include in the interim and final evaluations details of the sharing between customs and other border authorities of equipment financed under the Instrument to the extent that relevant information has been provided by the Member States. In addition to the interim and final evaluations of the Instrument, annual progress reports should, as part of the performance reporting system, be issued to monitor the implementation of the Instrument. Those reports should include a summary of the lessons learnt and, where appropriate, of the obstacles encountered, and shortfalls discovered in the context of the activities of the Instrument that took place in the year in question. Those annual progress reports should be communicated to the European Parliament and the Council. (27) In order to respond appropriately to evolving policy priorities, threats and technologies, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the indicative list of customs control equipment that may be used to achieve the customs control purposes and the list of indicators to measure the achievement of the specific objective. It is of particular importance that the Commission carry out appropriate and fully transparent consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (28) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (12) and Council Regulations (EC, Euratom) No 2988/95 (13), (Euratom, EC) No 2185/96 (14) and (EU) 2017/1939 (15), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union, as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (16). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (29) The forms of funding and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objective of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. Those forms and methods should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (30) Since the objective of this Regulation, which is to establish an Instrument that supports the customs union and customs authorities by providing financial support for the purchase, maintenance and upgrading of customs control equipment, cannot be sufficiently achieved by the Member States alone further to objective imbalances existing at geographical level amongst them, but can rather, by reason of the equivalent level and quality of results of customs controls that a coordinated approach and a centralised funding will help providing, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (31) The recipients of Union funding should acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. Such information should show the added value of the Instrument in supporting the customs union, and in particular, how it helps customs authorities to fulfil their missions, as well as the efforts of the Commission to ensure budgetary transparency. Furthermore, in order to ensure transparency the Commission should regularly provide information to the public relating to the Instrument, its actions and results, referring to, inter alia, the work programmes adopted under this Regulation. (32) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the multiannual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter Jointly with the Regulation establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy, this Regulation establishes an Integrated Border Management Fund (the \u2018Fund\u2019) for the period from 1 January 2021 to 31 December 2027. As part of that Fund, this Regulation establishes an Instrument to provide financial support for the purchase, maintenance and upgrading of customs control equipment (the \u2018Instrument\u2019) for the period from 1 January 2021 to 31 December 2027. The duration of the Instrument shall be aligned to the duration of the multiannual financial framework. This Regulation lays down the objectives of the Instrument, the budget for the period 2021 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018customs authorities\u2019 means the customs authorities as defined in point (1) of Article 5 of Regulation (EU) No 952/2013; (2) \u2018customs controls\u2019 means the customs controls as defined in point (3) of Article 5 of Regulation (EU) No 952/2013; (3) \u2018customs control equipment\u2019 means equipment intended primarily for performing customs controls; (4) \u2018mobile customs control equipment\u2019 means any means of transport that, beyond its mobile capacities, is itself intended to be a piece of customs control equipment or that is fully equipped with customs control equipment; (5) \u2018maintenance\u2019 means preventive, corrective and predictive interventions, including operational and functional checks, servicing, repair and overhaul of a piece of customs control equipment necessary in order for it to retain, or to be restored to, its specified operable condition with a view to it achieving its maximum useful life, but excluding any upgrading; (6) \u2018upgrade\u2019 means evolutive interventions necessary for bringing an existing piece of customs control equipment from an outdated to a state-of-the-art specified operable condition. Article 3 Instrument objectives 1. As part of the Fund and with a view to achieving the long-term aim of the harmonised application of customs controls by the Member States, the general objective of the Instrument is to support the customs union and customs authorities in their mission to protect the financial and economic interests of the Union and its Member States, to ensure security and safety within the Union and to protect the Union from illegal trade while facilitating legitimate business activity. 2. The specific objective of the Instrument is to contribute to adequate and equivalent results of customs controls through the transparent purchase, maintenance and upgrading of relevant and reliable state-of-the-art customs control equipment that is secure, safe and environmental-friendly, thereby helping the customs authorities act as one to protect the interests of the Union. Article 4 Budget 1. The financial envelope for the implementation of the Instrument for the period 2021\u20132027 shall be EUR 1 006 407 000 in current prices. 2. The amount referred to in paragraph 1 may also cover expenses for preparation, monitoring, control, audit, evaluation and other activities for managing the Instrument and evaluating the achievement of its objectives. It may also cover expenses linked to studies, meetings of experts, information and communication actions that are related to the objectives of the Instrument, as well as expenses linked to information technology networks focusing on information processing and exchange, including corporate information technology tools and other technical and administrative assistance needed in connection with the management of the Instrument. Article 5 Implementation and forms of Union funding 1. The Instrument shall be implemented under direct management in accordance with the Financial Regulation. 2. The Instrument may provide funding in any of the forms laid down in the Financial Regulation and in particular by means of grants. 3. When the action that is supported under the Instrument involves the purchase or upgrade of customs control equipment, the Commission shall set up a coordination mechanism to ensure the interoperability of the customs control equipment purchased with the support of Union programmes and instruments, and therefore its efficient use. CHAPTER II ELIGIBILITY Article 6 Eligible actions 1. In order for actions to be eligible for funding under the Instrument, those actions must comply with the following requirements: (a) implement the objectives set out in Article 3; and (b) support the purchase, maintenance or upgrading of customs control equipment including innovative detection technology equipment, that has one or more of the following customs control purposes: (1) non-intrusive inspection; (2) indication of hidden objects on humans; (3) radiation detection and nuclide identification; (4) analysis of samples in laboratories; (5) sampling and field analysis of samples; (6) handheld search. Annex I contains an indicative list of customs control equipment that may be used to achieve the customs control purposes referred to in points (1) to (6) of the first subparagraph. 2. In duly justified cases, actions under the first subparagraph of paragraph 1 may also cover the transparent purchase, maintenance and upgrading of customs control equipment for testing new pieces of equipment or new functionalities for existing pieces of equipment in operational conditions. 3. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, taking into account the delayed entry into force of this Regulation and in order to avoid any delay in Union support which could be prejudicial to the Union\u2019s interest in being properly equipped to ensure the efficient and effective operation of the customs union, costs incurred in respect of actions supported under this Regulation may, for a limited period, exceptionally be considered eligible from 1 January 2021, even if those actions were implemented and those costs incurred before the grant application was submitted. 4. The Commission is empowered to adopt delegated acts in accordance with Article 14 to amend this Regulation by updating, where necessary, the indicative list of customs control equipment set out in Annex I. 5. Customs control equipment financed under this Instrument should be used primarily for customs controls, but may also be used for additional purposes, including, in support of the national border management authorities and investigation, for the control of persons. Such customs control equipment shall not be systematically shared between customs and other border authorities. 6. The Commission shall encourage the joint procurement and joint testing of customs control equipment by two or more Member States. Article 7 Eligible entities By way of derogation from Article 197 of the Financial Regulation, the eligible entities shall be the customs authorities on condition that they provide the information necessary for the assessment of needs referred to in Article 11(4) of this Regulation. Article 8 Co-financing rate 1. The Instrument may finance up to 80 % of the total eligible costs of an action. 2. Any funding in excess of that ceiling shall be granted only in duly justified exceptional circumstances. Article 9 Eligible costs The costs directly related to actions referred to in Article 6 shall be eligible for funding under the Instrument. The following costs shall not be eligible for funding under the Instrument: (a) costs related to the purchase of land; (b) costs relating to training or the upgrading of skills, other than the introductory training included in the purchase or upgrade contract; (c) costs relating to infrastructure, such as buildings or outdoor facilities, as well as to furniture; (d) costs associated with electronic systems, with the exception of software and software updates directly necessary to use the customs control equipment and with the exception of the electronic software and programming necessary to interlink existing software with the customs control equipment; (e) costs of networks, such as secured or unsecured communication channels, or subscriptions, with the exception of networks or subscriptions exclusively necessary to use the customs control equipment; (f) costs of transport means, such as vehicles, aircrafts or ships, with the exception of mobile customs control equipment; (g) costs of consumables, including reference or calibration material, for customs control equipment; (h) costs relating to personal protective equipment. CHAPTER III GRANTS Article 10 Award, complementarity and combined funding 1. Grants under the Instrument shall be awarded and managed in accordance with Title VIII of the Financial Regulation. 2. In accordance with point (f) of the first paragraph of Article 195 of the Financial Regulation, grants shall be awarded without a call for proposals to the entities that are eligible under Article 7 of this Regulation. 3. An action that has received a contribution under the Instrument may also receive a contribution from the Customs programme or from another Union programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 4. The work of the evaluation committee referred to in Article 150 of the Financial Regulation shall be based on the general principles applicable to grants laid down in Article 188 of that Regulation and, in particular, on the principles of equal treatment and transparency laid down in points (a) and (b) of that Article, as well as on the principle of non-discrimination. 5. The evaluation committee shall evaluate proposals on the basis of the award criteria, taking into account, where appropriate, the relevance of the proposed action in view of the objectives pursued, the quality of the proposed action, its impact, including its economic, social and environmental impact, and its budget and cost-effectiveness. CHAPTER IV PROGRAMMING, MONITORING AND EVALUATION Article 11 Work programme 1. The Instrument shall be implemented through work programmes as referred to in Article 110(2) of the Financial Regulation. 2. The Commission shall adopt implementing acts establishing those work programmes. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2). 3. The work programmes shall aim to achieve the objectives set out in Article 3 through actions in accordance with Article 6. The work programmes shall set out the total amount of the financing plan for all actions. In addition, they shall set out: (a) for each action: (i) the objectives pursued and the expected results, in accordance with the general and specific objectives set out in Article 3; (ii) a description of the actions to be financed; (iii) where appropriate, an indication of the amount allocated to each action; and (iv) the method of implementation and an indicative implementation timetable; (b) for grants, the maximum rate of co-financing referred to in Article 8. 4. The preparation of the work programmes referred to in paragraph 1 shall be supported by an assessment of the needs of the customs authorities. That assessment of needs shall be based on the following: (a) a common categorisation of border crossing points; (b) a comprehensive description of available customs control equipment; (c) a common list of customs control equipment that should be available, by reference to the category of border crossing points; and (d) an estimate of financial needs. The assessment of needs shall be based on actions carried out under the Customs 2020 programme established by Regulation (EU) No 1294/2013 of the European Parliament and of the Council (17) or under the Customs programme, and shall be updated regularly at least every three years. Article 12 Monitoring and reporting 1. Indicators to report on the progress of the Instrument towards the achievement of the general and specific objectives set out in Article 3 are listed in Annex II. 2. To ensure the effective assessment of the Instrument\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts in accordance with Article 14 to amend Annex II with regard to the indicators where considered necessary, as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 3. The performance reporting system shall ensure that data for monitoring the implementation and results of the Instrument are collected efficiently, effectively and in a timely manner. To that end, proportionate reporting requirements shall be imposed on the recipients of Union funds. 4. Where the cost of a piece of customs control equipment exceeds EUR 10 000 exclusive of taxes, the reporting requirements referred to in paragraph 3 shall include at least the annual communication to the Commission of the following information: (a) a detailed list of the customs control equipment financed under the Instrument; (b) information on the use of the customs control equipment, including any related results, and supported, where appropriate, by relevant statistics. Article 13 Evaluation 1. Evaluations shall be carried out in a timely manner so that they can be used in the decision-making process. 2. An interim evaluation of the Instrument shall be carried out by the Commission once there is sufficient information available about its implementation, but no later than four years after the start of that implementation. In its interim evaluation, the Commission shall assess the performance of the Instrument, including aspects such as its effectiveness, efficiency, coherence and relevance, as well as the synergies within the Instrument and Union added value. 3. At the end of the implementation of the Instrument, but no later than four years after the end of the period specified in Article 1, a final evaluation of the Instrument shall be carried out by the Commission. 4. The Commission shall communicate the conclusions of the evaluations, accompanied by its observations and lessons learnt, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. CHAPTER V EXERCISE OF THE DELEGATION AND COMMITTEE PROCEDURE Article 14 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 6(4) and 12(2) shall be conferred on the Commission until 31 December 2027. The Commission shall draw up a report in respect of the delegation of power not later than nine months before that date. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 6(4) and 12(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 6(4) and 12(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 15 Committee procedure 1. The Commission shall be assisted by the Customs Programme Committee established by Article 17 of Regulation (EU) 2021/444. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. CHAPTER VI TRANSITIONAL AND FINAL PROVISIONS Article 16 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the Instrument, to actions taken pursuant to the Instrument and to the results obtained. 3. Financial resources allocated to the Instrument shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. Article 17 Transitional provision If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 4(2), to enable the management of actions not completed by 31 December 2027. Article 18 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 June 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 62, 15.2.2019, p. 67. (2) Position of the European Parliament of 16 April 2019 (OJ C 158, 30.4.2021, p. 133) and position of the Council at first reading of 27 May 2021 (OJ C 227, 14.6.2021, p. 1). Position of the European Parliament of 23 June 2021 (not yet published in the Official Journal). (3) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (4) OJ L 282, 19.10.2016, p. 4. (5) OJ L 433 I, 22.12.2020, p. 28. (6) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (7) Regulation (EU) 2021/444 of the European Parliament and of the Council of 11 March 2021 establishing the Customs programme for cooperation in the field of customs and repealing Regulation (EU) No 1294/2013 (OJ L 87, 15.3.2021, p. 1). (8) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (9) Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, p. 1). (10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (11) OJ L 123, 12.5.2016, p. 1. (12) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (13) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (14) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (15) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (16) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (17) Regulation (EU) No 1294/2013 of the European Parliament and of the Council of 11 December 2013 establishing an action programme for customs in the European Union for the period 2014-2020 (Customs 2020) and repealing Decision No 624/2007/EC (OJ L 347, 20.12.2013, p. 209). ANNEX I INDICATIVE LIST OF CUSTOMS CONTROL EQUIPMENT THAT MAY BE USED TO ACHIEVE THE CUSTOMS CONTROL PURPOSES LISTED IN POINT (B) OF THE FIRST SUBPARAGRAPH OF ARTICLE 6(1) CUSTOMS CONTROL PURPOSE CUSTOMS CONTROL EQUIPMENT CATEGORY APPLICATION 1. Non-intrusive inspection X-ray scanner \u2013 High energy Containers, trucks, rail wagons and vehicles X-ray scanner \u2013 Low energy Pallets, boxes and parcels Passenger baggage Vehicles X-ray backscatter Containers Trucks Vehicles Other Automatic Number Plate/Container Recognition Systems Vehicle weighting scales Forklifts and similar mobile customs control equipment 2. Indication of hidden objects on humans (1) X-ray based backscatter portal Mainly used in airports to detect hidden objects on humans (drugs, explosives, cash) Body scanner Millimetre wave-based security scanner 3. Radiation detection and nuclide identification Radiological and Nuclear Detectors Personal Radiation Monitor/detector (PRM) Handheld Radiation detector Isotope Identification Device (RIID) Radiation Portal Monitor (RPM) Spectrometric Portal Monitor for isotope identification (SPM) 4. Analysis of samples in laboratories Equipment for the identification, quantification and verification of all possible goods Gas and liquid chromatography (GC, LC, HPLC etc.) Spectrometry and techniques combined with spectrometry (IR, Raman, UV-VIS, Fluorescence, GC-MS etc.) X-ray equipment (XRF etc.) NMR spectrometry and Stable isotope analyses Other laboratory equipment (AAS, Distillation Analyser, DSC, Electrophoresis, Microscope, LSC, Smoking machine etc.) 5. Sampling and field analysis of samples Trace detection based on Ion Mobility Spectrometry (IMS) Portable equipment to screen traces of specific threat materials Canine trace detection Applied to a range of risks on small and larger objects Sampling Tools to take samples, fume hood, glovebox Mobile laboratories Vehicle fully housing equipment for field analysis of samples Handheld detectors Analysis of organic materials, metals and alloys Chemical colorimetric tests Raman spectroscopy Infrared spectroscopy X-ray fluorescence Gas detectors for containers 6. Handheld search Personal hand tools Pocket tools Mechanics tool kit Telescoping mirror Devices Endoscope Stationary or handed metal detector Cameras to check the under-side of vehicles Ultrasonic device Density meter Other Underwater search (1) Subject to applicable legislative provisions and other recommendations as regards the protection of health and the respect of privacy. ANNEX II INDICATORS FOR REPORTING ON THE PROGRESS OF THE INSTRUMENT IN ACHIEVING THE GENERAL AND SPECIFIC OBJECTIVES SET OUT IN ARTICLE 3 To report on the progress of the Instrument towards the achievement of the general and specific objectives set out in Article 3, the following indicators shall be used: Equipment (a) Availability at land border crossing points of customs control equipment meeting agreed standards (by type of equipment) (b) Availability at sea border crossing points of customs control equipment meeting agreed standards (by type of equipment) (c) Availability at air border crossing points of customs control equipment meeting agreed standards (by type of equipment (d) Availability at postal border crossing points of customs control equipment meeting agreed standards (by type of equipment) (e) Availability at rail border crossing points of customs control equipment meeting agreed standards (by type of equipment)", "summary": "EU instrument for financial support for customs control equipment (2021\u20132027) EU instrument for financial support for customs control equipment (2021\u20132027) SUMMARY OF: Regulation (EU) 2021/1077 establishing, as part of the Integrated Border Management Fund, the instrument for financial support for customs control equipment WHAT IS THE AIM OF THE REGULATION? It establishes a fund to support European Union (EU) Member States in the purchase, maintenance and upgrading of customs control equipment. It sets out the general and specific objectives and the size, form and rules of EU funding from 1 January 2021 to 31 December 2027 \u2013 the period covered by the current multiannual financial framework. KEY POINTS The fund\u2019s general objectives are to support customs authorities\u2019 efforts to: protect EU and national financial and economic interests; ensure security and safety within the EU; protect the EU from illegal trade; facilitate legitimate business activity. The fund\u2019s specific objective is to contribute to adequate and equivalent customs controls by purchasing, maintaining and upgrading state-of-the-art customs control equipment that is reliable, secure, safe and environmentally friendly. The budget for the 7-year fund is \u20ac1,006,407,000 (current prices). The financing may be used for preparation, monitoring, control, audit, evaluation and other activities, including legitimate expenses such as information technology networks. To be eligible for funding, activities must: implement the regulation\u2019s general and specific aims; support the purchase, maintenance or upgrading of equipment, such as X-ray scanners and automated number plate detection systems (Annex I provides an indicative list of items), that serves one or more of the following purposes: non-intrusive inspection,indication of hidden objects on humans,radiation detection and nuclide identification,analysis of laboratory samples,sampling and field analysis,handheld search. Eligible costs The fund may finance up to 80% of total eligible costs. The following are not eligible: land purchase; training or upgrading skills, apart from introductory training; infrastructure, such as buildings, furniture and outdoor facilities; electronic systems apart from software, programming and updates necessary for the use or interlinking of the equipment; networks or subscriptions, unless necessary for the use of the equipment; transport, such as vehicles, aircraft or ships, except for mobile customs control equipment; personal protective equipment. Recipients of the fund\u2019s support must acknowledge the origin and ensure the visibility of the financing. The European Commission: adopts implementing acts to establish work programmes for each of the fund\u2019s activities; adopts delegated acts to amend as necessary the list of indicators (Annex II), such as customs control equipment at different land, sea, air and postal borders, to measure progress made towards the different objectives; undertakes regular evaluations, with an interim one no later than 4 years after the start of the fund and a final one by the end of 2031. It sends these, along with its comments, to the European Parliament, the Council of the European Union, the European Economic and Social Committee and the Committee of the Regions. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND The customs control equipment fund is one component of the EU\u2019s integrated border management fund; the other is the border management and visa instrument set up under Regulation (EU) 2021/1148 (see summary). The first relates to checks on goods, the second to checks on people. The fund contributes to implementing the customs action plan adopted in September 2020 and to the customs programme (2021\u20132027) set up under Regulation (EU) 2021/444 (see summary). For further information, see: Customs control equipment instrument (European Commission). MAIN DOCUMENT Regulation (EU) 2021/1077 of the European Parliament and of the Council of 24 June 2021 establishing, as part of the Integrated Border Management Fund, the instrument for financial support for customs control equipment (OJ L 234, 2.7.2021, pp. 1\u201317). RELATED DOCUMENTS Regulation (EU) 2021/1148 of the European Parliament and of the Council of 7 July 2021 establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy (OJ L 251, 15.7.2021, pp. 48\u201393). Regulation (EU) 2021/444 of the European Parliament and of the Council of 11 March 2021 establishing the Customs programme for cooperation in the field of customs and repealing Regulation (EU) No 1294/2013 (OJ L 87, 15.3.2021, pp. 1\u201316). Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee \u2013 Taking the Customs Union to the Next Level: a Plan for Action (COM(2020) 581 final, 28.9.2020). Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, pp. 1\u2013101). Successive amendments to Regulation (EU) No 952/2013 have been incorporated in the original text. This consolidated version is of documentary value only. last update 24.11.2021"}
{"article": "14.6.2019 EN Official Journal of the European Union L 158/125 DIRECTIVE (EU) 2019/944 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) A number of amendments are to be made to Directive 2009/72/EC of the European Parliament and of the Council (4). In the interests of clarity, that Directive should be recast. (2) The internal market for electricity, which has been progressively implemented throughout the Union since 1999, aims, by organising competitive electricity markets across country borders, to deliver real choice for all Union final customers, be they citizens or businesses, new business opportunities, competitive prices, efficient investment signals and higher standards of service, and to contribute to security of supply and sustainability. (3) Directive 2003/54/EC of the European Parliament and of the Council (5) and Directive 2009/72/EC have made a significant contribution towards the creation of the internal market for electricity. However, the Union's energy system is in the middle of a profound change. The common goal of decarbonising the energy system creates new opportunities and challenges for market participants. At the same time, technological developments allow for new forms of consumer participation and cross-border cooperation. There is a need to adapt the Union market rules to a new market reality. (4) The Commission Communication of 25 February 2015, entitled \u2018A Framework Strategy for a Resilient Energy Union with a Forward-Looking Climate Change Policy\u2019, sets out a vision of an Energy Union with citizens at its core, where citizens take ownership of the energy transition, benefit from new technologies to reduce their bills and participate actively in the market, and where vulnerable consumers are protected. (5) The Commission Communication of 15 July 2015, entitled \u2018Delivering a New Deal for Energy Consumers\u2019, put forward the Commission's vision for a retail market that better serves energy consumers, including by better linking wholesale and retail markets. By taking advantage of new technology, new and innovative energy service companies should enable all consumers to fully participate in the energy transition, managing their consumption to deliver energy efficient solutions which save them money and contribute to the overall reduction of energy consumption. (6) The Commission Communication of 15 July 2015, entitled \u2018Launching the public consultation process on a new energy market design\u2019, highlighted that the move away from generation in large central generating installations towards decentralised production of electricity from renewable sources and towards decarbonised markets requires adapting the current rules of electricity trading and changing the existing market roles. The Communication underlined the need to organise electricity markets in a more flexible manner and to fully integrate all market players \u2013 including producers of renewable energy, new energy service providers, energy storage and flexible demand. It is equally important for the Union to invest urgently in interconnection at Union level for the transfer of energy through high-voltage electricity transmission systems. (7) With a view to creating an internal market for electricity, Member States should foster the integration of their national markets and cooperation among system operators at Union and regional level, and incorporate isolated systems that form electricity islands that persist in the Union. (8) In addition to addressing new challenges, this Directive seeks to address the persisting obstacles to the completion of the internal market for electricity. The refined regulatory framework needs to contribute to overcoming the current problems of fragmented national markets which are still often determined by a high degree of regulatory interventions. Such interventions have led to obstacles to the supply of electricity on equal terms as well as higher costs in comparison to solutions based on cross-border cooperation and market-based principles. (9) The Union would most effectively meet its renewable energy targets through the creation of a market framework that rewards flexibility and innovation. A well-functioning electricity market design is the key factor enabling the uptake of renewable energy. (10) Consumers have an essential role to play in achieving the flexibility necessary to adapt the electricity system to variable and distributed renewable electricity generation. Technological progress in grid management and the generation of renewable electricity has unlocked many opportunities for consumers. Healthy competition in retail markets is essential to ensuring the market-driven deployment of innovative new services that address consumers' changing needs and abilities, while increasing system flexibility. However, the lack of real-time or near real-time information provided to consumers about their energy consumption has prevented them from being active participants in the energy market and the energy transition. By empowering consumers and providing them with the tools to participate more in the energy market, including participating in new ways, it is intended that citizens in the Union benefit from the internal market for electricity and that the Union's renewable energy targets are attained. (11) The freedoms which the Treaty on the Functioning of the European Union (TFEU) guarantees the citizens of the Union \u2014 inter alia, the free movement of goods, the freedom of establishment and the freedom to provide services \u2014 are achievable only in a fully open market, which enables all consumers freely to choose their suppliers and all suppliers freely to deliver to their customers. (12) Promoting fair competition and easy access for different suppliers is of the utmost importance for Member States in order to allow consumers to take full advantage of the opportunities of a liberalised internal market for electricity. Nonetheless, it is possible that market failure persists in peripheral small electricity systems and in systems not connected with other Member States, where electricity prices fail to provide the right signal to drive investment, and therefore requires specific solutions to ensure an adequate level of security of supply. (13) In order to foster competition and ensure the supply of electricity at the most competitive price, Member States and regulatory authorities should facilitate cross-border access for new suppliers of electricity from different energy sources as well as for new providers of generation, energy storage and demand response. (14) Member States should ensure that no undue barriers exist within the internal market for electricity as regards market entry, operation and exit. At the same time, it should be clarified that that obligation is without prejudice to the competence that Member States retain in relation to third countries. That clarification should not be interpreted as enabling a Member State to exercise the exclusive competence of the Union. It should also be clarified that market participants from third countries who operate within the internal market are to comply with the applicable Union and national law in the same manner as other market participants. (15) Market rules allow for the entry and exit of producers and suppliers based on their assessment of the economic and financial viability of their operations. That principle is not incompatible with the possibility for Member States to impose on undertakings operating in the electricity sector public service obligations in the general economic interest in accordance with the Treaties, in particular with Article 106 TFEU, and with this Directive and Regulation (EU) 2019/943 of the European Parliament and of the Council (6). (16) The European Council of 23 and 24 October 2014 stated in its conclusions that the Commission, supported by the Member States, is to take urgent measures in order to ensure the achievement of a minimum target of 10 % of existing electricity interconnections, as a matter of urgency, and no later than 2020, at least for Member States which have not yet attained a minimum level of integration in the internal energy market, which are the Baltic States, Portugal and Spain, and for Member States which constitute their main point of access to the internal energy market. It further stated that the Commission is also to report regularly to the European Council with the objective of arriving at a 15 % target by 2030. (17) Sufficient physical interconnection with neighbouring countries is important to enable Member States and neighbouring countries to benefit from the positive effects of the internal market as stressed in the Commission Communication of 23 November 2017, entitled \u2018Communication on strengthening Europe's energy networks\u2019, and as reflected in Member States' integrated national energy and climate plans under Regulation (EU) 2018/1999 of the European Parliament and of the Council (7). (18) Electricity markets differ from other markets such as those for natural gas, for example because they involve the trading in a commodity which cannot currently be easily stored and which is produced using a large variety of generating installations, including through distributed generation. This has been reflected in the different approaches to the regulatory treatment of interconnectors in the electricity and gas sectors. The integration of electricity markets requires a high degree of cooperation among system operators, market participants and regulatory authorities, in particular where electricity is traded via market coupling. (19) Securing common rules for a true internal market and a broad supply of electricity that is accessible to all should also be one of the main goals of this Directive. To that end, undistorted market prices would provide incentives for cross-border interconnections and for investments in new electricity generation while leading to price convergence in the long term. (20) Market prices should give the right incentives for the development of the network and for investing in new electricity generation. (21) Different types of market organisation exist in the internal market for electricity. The measures that Member States could take in order to ensure a level playing field should be based on overriding requirements of general interest. The Commission should be consulted on the compatibility of those measures with the TFEU and with other Union law. (22) Member States should maintain wide discretion to impose public service obligations on electricity undertakings in pursuing objectives of general economic interest. Member States should ensure that household customers and, where Member States consider it to be appropriate, small enterprises, enjoy the right to be supplied with electricity of a specified quality at clearly comparable, transparent and competitive prices. Nevertheless, public service obligations in the form of price setting for the supply of electricity constitute a fundamentally distortive measure that often leads to the accumulation of tariff deficits, the limitation of consumer choice, poorer incentives for energy saving and energy efficiency investments, lower standards of service, lower levels of consumer engagement and satisfaction, and the restriction of competition, as well as to there being fewer innovative products and services on the market. Consequently, Member States should apply other policy tools, in particular targeted social policy measures, to safeguard the affordability of electricity supply to their citizens. Public interventions in price setting for the supply of electricity should be carried out only as public service obligations and should be subject to specific conditions set out in this Directive. A fully liberalised, well-functioning retail electricity market would stimulate price and non-price competition among existing suppliers and provide incentives to new market entrants, thereby improving consumer choice and satisfaction. (23) Public service obligations in the form of price setting for the supply of electricity should be used without overriding the principle of open markets in clearly defined circumstances and beneficiaries and should be limited in duration. Such circumstances might occur for example where supply is severely constrained, causing significantly higher electricity prices than normal, or in the event of a market failure where interventions by regulatory authorities and competition authorities have proven to be ineffective. This would disproportionately affect households and, in particular, vulnerable customers who typically expend a higher share of their disposable income on energy bills compared to high-income consumers. In order to mitigate the distortive effects of public service obligations in price setting for the supply of electricity, Member States applying such interventions should put in place additional measures, including measures to prevent distortions of price setting in the wholesale market. Member States should ensure that all beneficiaries of regulated prices are able to benefit fully from the offers available on the competitive market when they choose to do so. To that end, those beneficiaries need to be equipped with smart metering systems and have access to dynamic electricity price contracts. In addition, they should be directly and regularly informed of the offers and savings available on the competitive market, in particular relating to dynamic electricity price contracts, and should be provided with assistance to respond to and benefit from market-based offers. (24) The entitlement of beneficiaries of regulated prices to receive individual smart meters without extra costs should not prevent Member States from modifying the functionality of smart metering systems where smart meter infrastructure does not exist because the cost-benefit assessment regarding the deployment of smart metering systems was negative. (25) Public interventions in price setting for the supply of electricity should not lead to direct cross-subsidisation between different categories of customer. According to that principle, price systems must not explicitly make certain categories of customer bear the cost of price interventions that affect other categories of customer. For example, a price system, in which the cost is borne by suppliers or other operators in a non-discriminatory manner, should not be considered to be direct cross-subsidisation. (26) In order to ensure the maintenance of the high standards of public service in the Union, all measures taken by Member States to achieve the objective of this Directive should be regularly notified to the Commission. The Commission should regularly publish a report analysing measures taken at national level to achieve public service objectives and comparing their effectiveness, with a view to making recommendations as regards measures to be taken at national level to achieve high standards of public service. (27) It should be possible for Member States to appoint a supplier of last resort. That supplier might be the sales division of a vertically integrated undertaking which also performs distribution functions, provided that it meets the unbundling requirements of this Directive. (28) It should be possible for measures implemented by Member States for the purpose of achieving the objectives of social and economic cohesion to include, in particular, the provision of adequate economic incentives, using, where appropriate, any existing national and Union tools. Such tools may include liability mechanisms to guarantee the necessary investment. (29) To the extent that measures taken by Member States to fulfil public service obligations constitute State aid under Article 107(1) TFEU, there is an obligation under Article 108(3) TFEU to notify them to the Commission. (30) Cross\u2013sectorial law provides a strong basis for consumer protection for a wide range of energy services that exist, and is likely to evolve. Nevertheless, certain basic contractual rights of customers should be clearly established. (31) Plain and unambiguous information should be made available to consumers concerning their rights in relation to the energy sector. The Commission has established, after consulting relevant stakeholders, including Member States, regulatory authorities, consumer organisations and electricity undertakings, an energy consumer checklist that provides consumers with practical information about their rights. That checklist should be kept up to date, provided to all consumers and made publicly available. (32) Several factors impede consumers from accessing, understanding and acting upon the various sources of market information available to them. It follows that the comparability of offers should be improved and barriers to switching should be minimised to the greatest practicable extent without unduly limiting consumer choice. (33) Smaller customers are still being charged a broad range of fees directly or indirectly as a result of switching supplier. Such fees make it more difficult to identify the best product or service and diminish the immediate financial advantage of switching. Although removing such fees might limit consumer choice by eliminating products based on rewarding consumer loyalty, restricting their use further should improve consumer welfare, consumer engagement and competition in the market. (34) Shorter switching times are likely to encourage consumers to search for better energy deals and switch supplier. With the increased deployment of information technology, by the year 2026, the technical switching process of registering a new supplier in a metering point at the market operator should typically be possible to complete within 24 hours on any working day. Notwithstanding other steps in the switching process that are to be completed before the technical process of switching is initiated, ensuring that it is possible by that date for the technical process of switching to take place within 24 hours would minimise switching times, helping to increase consumer engagement and retail competition. In any event, the total duration of the switching process should not exceed three weeks from the date of the customer's request. (35) Independent comparison tools, including websites, are an effective means for smaller customers to assess the merits of the different energy offers that are available on the market. Such tools lower search costs as customers no longer need to collect information from individual suppliers and service providers. Such tools can provide the right balance between the need for information to be clear and concise and the need for it to be complete and comprehensive. They should aim to include the broadest possible range of available offers, and to cover the market as completely as is feasible so as to give the customer a representative overview. It is crucial that smaller customers have access to at least one comparison tool and that the information given on such tools be trustworthy, impartial and transparent. To that end, Member States could provide for a comparison tool that is operated by a national authority or a private company. (36) Greater consumer protection is guaranteed by the availability of effective, independent out-of-court dispute settlement mechanisms for all consumers, such as an energy ombudsman, a consumer body or a regulatory authority. Member States should introduce speedy and effective complaint-handling procedures. (37) All consumers should be able to benefit from directly participating in the market, in particular by adjusting their consumption according to market signals and, in return, benefiting from lower electricity prices or other incentive payments. The benefits of such active participation are likely to increase over time, as the awareness of otherwise passive consumers is raised about their possibilities as active customers and as the information on the possibilities of active participation becomes more accessible and better known. Consumers should have the possibility of participating in all forms of demand response. They should therefore have the possibility of benefiting from the full deployment of smart metering systems and, where such deployment has been negatively assessed, of choosing to have a smart metering system and a dynamic electricity price contract. This should allow them to adjust their consumption according to real-time price signals that reflect the value and cost of electricity or transportation in different time periods, while Member States should ensure the reasonable exposure of consumers to wholesale price risk. Consumers should be informed about benefits and potential price risks of dynamic electricity price contracts. Member States should also ensure that those consumers who choose not to actively engage in the market are not penalised. Instead, their ability to make informed decisions on the options available to them should be facilitated in the manner that is the most suited to domestic market conditions. (38) In order to maximise the benefits and effectiveness of dynamic electricity pricing, Member States should assess the potential for making more dynamic or reducing the share of fixed components in electricity bills, and where such potential exists, should take appropriate action. (39) All customer groups (industrial, commercial and households) should have access to the electricity markets to trade their flexibility and self-generated electricity. Customers should be allowed to make full use of the advantages of aggregation of production and supply over larger regions and benefit from cross-border competition. Market participants engaged in aggregation are likely to play an important role as intermediaries between customer groups and the market. Member States should be free to choose the appropriate implementation model and approach to governance for independent aggregation while respecting the general principles set out in this Directive. Such a model or approach could include choosing market-based or regulatory principles which provide solutions to comply with this Directive, such as models where imbalances are settled or where perimeter corrections are introduced. The chosen model should contain transparent and fair rules to allow independent aggregators to fulfil their roles as intermediaries and to ensure that the final customer adequately benefits from their activities. Products should be defined on all electricity markets, including ancillary services and capacity markets, so as to encourage the participation of demand response. (40) The Commission Communication of 20 July 2016, entitled \u2018European Strategy for Low-Emission Mobility\u2019, stresses the need for the decarbonisation of the transport sector and the reduction of its emissions, especially in urban areas, and highlights the important role that electromobility can play in contributing to those objectives. Moreover, the deployment of electromobility constitutes an important element of the energy transition. Market rules set out in this Directive should therefore contribute to creating favourable conditions for electric vehicles of all kinds. In particular, they should ensure the effective deployment of publicly accessible and private recharging points for electric vehicles and should ensure the efficient integration of vehicle charging into the system. (41) Demand response is pivotal to enabling the smart charging of electric vehicles and thereby enabling the efficient integration of electric vehicles into the electricity grid which will be crucial for the process of decarbonising transport. (42) Consumers should be able to consume, to store and to sell self-generated electricity to the market and to participate in all electricity markets by providing flexibility to the system, for instance through energy storage, such as storage using electric vehicles, through demand response or through energy efficiency schemes. New technology developments will facilitate those activities in the future. However, legal and commercial barriers exist, including, for example, disproportionate fees for internally consumed electricity, obligations to feed self-generated electricity to the energy system, and administrative burdens, such as the need for consumers who self-generate electricity and sell it to the system to comply with the requirements for suppliers, etc. Such obstacles, which prevent consumers from self-generating electricity and from consuming, storing or selling self-generated electricity to the market, should be removed while it should be ensured that such consumers contribute adequately to system costs. Member States should be able to have different provisions in their national law with respect to taxes and levies for individual and jointly-acting active customers, as well as for household and other final customers. (43) Distributed energy technologies and consumer empowerment have made community energy an effective and cost-efficient way to meet citizens' needs and expectations regarding energy sources, services and local participation. Community energy offers an inclusive option for all consumers to have a direct stake in producing, consuming or sharing energy. Community energy initiatives focus primarily on providing affordable energy of a specific kind, such as renewable energy, for their members or shareholders rather than on prioritising profit-making like a traditional electricity undertaking. By directly engaging with consumers, community energy initiatives demonstrate their potential to facilitate the uptake of new technologies and consumption patterns, including smart distribution grids and demand response, in an integrated manner. Community energy can also advance energy efficiency at household level and help fight energy poverty through reduced consumption and lower supply tariffs. Community energy also enables certain groups of household customers to participate in the electricity markets, who otherwise might not have been able to do so. Where they have been successfully operated such initiatives have delivered economic, social and environmental benefits to the community that go beyond the mere benefits derived from the provision of energy services. This Directive aims to recognise certain categories of citizen energy initiatives at the Union level as \u2018citizen energy communities\u2019, in order to provide them with an enabling framework, fair treatment, a level playing field and a well-defined catalogue of rights and obligations. Household customers should be allowed to participate voluntarily in community energy initiatives as well as to leave them, without losing access to the network operated by the community energy initiative or losing their rights as consumers. Access to a citizen energy community's network should be granted on fair and cost-reflective terms. (44) Membership of citizen energy communities should be open to all categories of entities. However, the decision-making powers within a citizen energy community should be limited to those members or shareholders that are not engaged in large-scale commercial activity and for which the energy sector does not constitute a primary area of economic activity. Citizen energy communities are considered to be a category of cooperation of citizens or local actors that should be subject to recognition and protection under Union law. The provisions on citizen energy communities do not preclude the existence of other citizen initiatives such as those stemming from private law agreements. It should therefore be possible for Member States to provide that citizen energy communities take any form of entity, for example that of an association, a cooperative, a partnership, a non-profit organisation or a small or medium-sized enterprise, provided that the entity is entitled to exercise rights and be subject to obligations in its own name. (45) The provisions of this Directive on citizen energy communities provide for rights and obligations, which are possible to deduce from other, existing rights and obligations, such as the freedom of contract, the right to switch supplier, the responsibilities of the distribution system operator, the rules on network charges, and balancing obligations. (46) Citizen energy communities constitute a new type of entity due to their membership structure, governance requirements and purpose. They should be allowed to operate on the market on a level playing field without distorting competition, and the rights and obligations applicable to the other electricity undertakings on the market should be applied to citizen energy communities in a non-discriminatory and proportionate manner. Those rights and obligations should apply in accordance with the roles that they undertake, such as the roles of final customers, producers, suppliers or distribution system operators. Citizen energy communities should not face regulatory restrictions when they apply existing or future information and communications technologies to share electricity produced using generation assets within the citizen energy community among their members or shareholders based on market principles, for example by offsetting the energy component of members or shareholders using the generation available within the community, even over the public network, provided that both metering points belong to the community. Electricity sharing enables members or shareholders to be supplied with electricity from generating installations within the community without being in direct physical proximity to the generating installation and without being behind a single metering point. Where electricity is shared, the sharing should not affect the collection of network charges, tariffs and levies related to electricity flows. The sharing should be facilitated in accordance with the obligations and correct timeframes for balancing, metering and settlement. The provisions of this Directive on citizen energy communities do not interfere with the competence of Member States to design and implement policies relating to the energy sector in relation to network charges and tariffs, or to design and implement energy policy financing systems and cost sharing, provided that those policies are non-discriminatory and lawful. (47) This Directive empowers Member States to allow citizen energy communities to become distribution system operators either under the general regime or as \u2018closed distribution system operators\u2019. Once a citizen energy community is granted the status of a distribution system operator, it should be treated as, and be subject to the same obligations as, a distribution system operator. The provisions of this Directive on citizen energy communities only clarify aspects of distribution system operation that are likely to be relevant for citizen energy communities, while other aspects of distribution system operation apply in accordance with the rules relating to distribution system operators. (48) Electricity bills are an important means by which final customers are informed. As well as providing data on consumption and costs, they can also convey other information that helps consumers to compare their current arrangements with other offers. However, disputes over bills are a very common source of consumer complaints, a factor which contributes to the persistently low levels of consumer satisfaction and engagement in the electricity sector. It is therefore necessary to make bills clearer and easier to understand, as well as to ensure that bills and billing information prominently display a limited number of important items of information that are necessary to enable consumers to regulate their energy consumption, compare offers and switch supplier. Other items of information should be made available to final customers in, with or signposted to within their bills. Such items should be displayed on the bill or be in a separate document attached to the bill, or the bill should contain a reference to where the final customer is easily able to find the information on a website, through a mobile application or by other means. (49) The regular provision of accurate billing information based on actual electricity consumption, facilitated by smart metering, is important for helping customers to control their electricity consumption and costs. Nevertheless, customers, in particular household customers, should have access to flexible arrangements for the actual payment of their bills. For example, it could be possible for customers to be provided with frequent billing information, while paying only on a quarterly basis, or there could be products for which the customer pays the same amount every month, independently of the actual consumption. (50) The provisions on billing in Directive 2012/27/EU of the European Parliament and of the Council (8) should be updated, streamlined and moved to this Directive, where they fit more coherently. (51) Member States should encourage the modernisation of distribution networks, such as through the introduction of smart grids, which should be built in a way that encourages decentralised generation and energy efficiency. (52) Engaging consumers requires appropriate incentives and technologies such as smart metering systems. Smart metering systems empower consumers because they allow them to receive accurate and near real-time feedback on their energy consumption or generation, and to manage their consumption better, to participate in and reap benefits from demand response programmes and other services, and to lower their electricity bills. Smart metering systems also enable distribution system operators to have better visibility of their networks, and as a consequence, to reduce their operation and maintenance costs and to pass those savings on to the consumers in the form of lower distribution tariffs. (53) When it comes to deciding at national level on the deployment of smart metering systems, it should be possible to base this decision on an economic assessment. That economic assessment should take into account the long-term benefits of the deployment of smart metering systems to consumers and the whole value chain, such as better network management, more precise planning and identification of network losses. Should that assessment conclude that the introduction of such metering systems is cost-effective only for consumers with a certain amount of electricity consumption, Member States should be able to take that conclusion into account when proceeding with the deployment of smart metering systems. However, such assessments should be reviewed regularly in response to significant changes in the underlying assumptions, or at least every four years, given the fast pace of technological developments. (54) Member States that do not systematically deploy smart metering systems should allow consumers to benefit from the installation of a smart meter, upon request and under fair and reasonable conditions, and should provide them with all the relevant information. Where consumers do not have smart meters, they should be entitled to meters that fulfil the minimum requirements necessary to provide them with the billing information specified in this Directive. (55) In order to assist consumers' active participation in the electricity markets, the smart metering systems to be deployed by Member States in their territory should be interoperable, and should be able to provide data required for consumer energy management systems. To that end, Member States should have due regard to the use of relevant available standards, including standards that enable interoperability on the level of the data model and the application layer, to best practices and the importance of the development of data exchange, to future and innovative energy services, to the deployment of smart grids and to the internal market for electricity. Moreover, the smart metering systems that are deployed should not represent a barrier to switching supplier, and should be equipped with fit-for-purpose functionalities that allow consumers to have near real-time access to their consumption data, to modulate their energy consumption and, to the extent that the supporting infrastructure permits, to offer their flexibility to the network and to electricity undertakings and to be rewarded for it, and to obtain savings in their electricity bills. (56) A key aspect of supplying customers is providing access to objective and transparent consumption data. Thus, consumers should have access to their consumption data and to the prices and service costs associated with their consumption, so that they can invite competitors to make offers based on that information. Consumers should also have the right to be properly informed about their energy consumption. Prepayments should not place a disproportionate disadvantage on their users, while different payment systems should be non-discriminatory. The information on energy costs that is provided to consumers sufficiently frequently would create incentives for energy savings because it would give customers direct feedback on the effects of investment in energy efficiency and on changes of behaviour. In that respect, the full implementation of Directive 2012/27/EU will help consumers to reduce their energy costs. (57) Currently, different models for the management of data have been developed or are under development in Member States following deployment of smart metering systems. Independently of the data management model it is important that Member States put in place transparent rules under which data can be accessed under non-discriminatory conditions and ensure the highest level of cybersecurity and data protection as well as the impartiality of the entities which process data. (58) Member States should take the necessary measures to protect vulnerable and energy poor customers in the context of the internal market for electricity. Such measures may differ according to the particular circumstances in the Member States in question and may include social or energy policy measures relating to the payment of electricity bills, to investment in the energy efficiency of residential buildings, or to consumer protection such as disconnection safeguards. Where universal service is also provided to small enterprises, measures to ensure universal service provision may differ according to whether those measures are aimed at household customers or small enterprises. (59) Energy services are fundamental to safeguarding the well-being of the Union citizens. Adequate warmth, cooling and lighting, and energy to power appliances are essential services to guarantee a decent standard of living and citizens' health. Furthermore, access to those energy services enables Union citizens to fulfil their potential and enhances social inclusion. Energy poor households are unable to afford those energy services due to a combination of low income, high expenditure on energy and poor energy efficiency of their homes. Member States should collect the right information to monitor the number of households in energy poverty. Accurate measurement should assist Member States in identifying households that are affected by energy poverty in order to provide targeted support. The Commission should actively support the implementation of the provisions of this Directive on energy poverty by facilitating the sharing of good practices between Member States. (60) Where Member States are affected by energy poverty and have not developed national action plans or other appropriate frameworks to tackle energy poverty, they should do so, with the aim of decreasing the number of energy poor customers. Low income, high expenditure on energy, and poor energy efficiency of homes are relevant factors in establishing criteria for the measurement of energy poverty. In any event, Member States should ensure the necessary supply for vulnerable and energy poor customers. In doing so, an integrated approach, such as in the framework of energy and social policy, could be used and measures could include social policies or energy efficiency improvements for housing. This Directive should enhance national policies in favour of vulnerable and energy poor customers. (61) Distribution system operators have to cost-efficiently integrate new electricity generation, especially installations generating electricity from renewable sources, and new loads such as loads that result from heat pumps and electric vehicles. For that purpose, distribution system operators should be enabled, and provided with incentives, to use services from distributed energy resources such as demand response and energy storage, based on market procedures, in order to efficiently operate their networks and to avoid costly network expansions. Member States should put in place appropriate measures such as national network codes and market rules, and should provide incentives to distribution system operators through network tariffs which do not create obstacles to flexibility or to the improvement of energy efficiency in the grid. Member States should also introduce network development plans for distribution systems in order to support the integration of installations generating electricity from renewable energy sources, facilitate the development of energy storage facilities and the electrification of the transport sector, and provide to system users adequate information regarding the anticipated expansions or upgrades of the network, as currently such procedures do not exist in the majority of Member States. (62) System operators should not own, develop, manage or operate energy storage facilities. In the new electricity market design, energy storage services should be market-based and competitive. Consequently, cross-subsidisation between energy storage and the regulated functions of distribution or transmission should be avoided. Such restrictions on the ownership of energy storage facilities is to prevent distortion of competition, to eliminate the risk of discrimination, to ensure fair access to energy storage services to all market participants and to foster the effective and efficient use of energy storage facilities, beyond the operation of the distribution or transmission system. That requirement should be interpreted and applied in accordance with the rights and principles established under the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019), in particular the freedom to conduct a business and the right to property guaranteed by Articles 16 and 17 of the Charter. (63) Where energy storage facilities are fully integrated network components that are not used for balancing or for congestion management, they should not, subject to approval by the regulatory authority, be required to comply with the same strict limitations for system operators to own, develop, manage or operate those facilities. Such fully integrated network components can include energy storage facilities such as capacitors or flywheels which provide important services for network security and reliability, and contribute to the synchronisation of different parts of the system. (64) With the objective of progress towards a completely decarbonised electricity sector that is fully free of emissions, it is necessary to make progress in seasonal energy storage. Such energy storage is an element that would serve as a tool for the operation of the electricity system to allow for short-term and seasonal adjustment, in order to cope with variability in the production of electricity from renewable sources and the associated contingencies in those horizons. (65) Non-discriminatory access to the distribution network determines downstream access to customers at retail level. To create a level playing field at retail level, the activities of distribution system operators should therefore be monitored so that distribution system operators are prevented from taking advantage of their vertical integration as regards their competitive position on the market, in particular in relation to household customers and small non-household customers. (66) Where a closed distribution system is used to ensure the optimal efficiency of an integrated supply that requires specific operational standards, or where a closed distribution system is maintained primarily for the use of the owner of the system, it should be possible to exempt the distribution system operator from obligations which would constitute an unnecessary administrative burden because of the particular nature of the relationship between the distribution system operator and the system users. Industrial sites, commercial sites or shared services sites such as train station buildings, airports, hospitals, large camping sites with integrated facilities, and chemical industry sites can include closed distribution systems because of the specialised nature of their operations. (67) Without the effective separation of networks from activities of generation and supply (effective unbundling), there is an inherent risk of discrimination not only in the operation of the network but also in the incentives for vertically integrated undertakings to invest adequately in their networks. (68) Only the removal of the incentive for vertically integrated undertakings to discriminate against competitors as regards network access and investment can ensure effective unbundling. Ownership unbundling, which implies the appointment of the network owner as the system operator and its independence from any supply and production interests, is clearly an effective and stable way to solve the inherent conflict of interests and to ensure security of supply. For that reason, the European Parliament, in its resolution of 10 July 2007 on prospects for the internal gas and electricity market, referred to ownership unbundling at transmission level as the most effective tool for promoting investments in infrastructure in a non-discriminatory way, fair access to the network for new entrants and transparency in the market. Under ownership unbundling, Member States should therefore be required to ensure that the same person or persons are not entitled to exercise control over a producer or supplier and, at the same time, exercise control or any right over a transmission system operator or transmission system. Conversely, control over a transmission system operator or transmission system should preclude the possibility of exercising control or any right over a producer or supplier. Within those limits, a producer or supplier should be able to have a minority shareholding in a transmission system operator or transmission system. (69) Any system for unbundling should be effective in removing any conflict of interests between producers, suppliers and transmission system operators, in order to create incentives for the necessary investments and to guarantee the access of new market entrants under a transparent and efficient regulatory regime and should not create an overly onerous regulatory regime for regulatory authorities. (70) Since ownership unbundling requires the restructuring of undertakings in some instances, Member States that decide to implement ownership unbundling should be granted additional time to apply the relevant provisions. In view of the vertical links between the electricity and gas sectors, the unbundling provisions should apply across the two sectors. (71) Under ownership unbundling, to ensure full independence of network operation from supply and generation interests, and to prevent exchanges of any confidential information, the same person should not be a member of the managing board of both a transmission system operator or a transmission system and an undertaking performing any of the functions of generation or supply. For the same reason, the same person should not be entitled to appoint members of the managing boards of a transmission system operator or a transmission system and to exercise control or any right over a producer or supplier. (72) The setting up of a system operator or transmission operator that is independent from supply and generation interests should enable a vertically integrated undertaking to maintain its ownership of network assets while ensuring the effective separation of interests, provided that such independent system operator or independent transmission operator performs all of the functions of a system operator, and provided that detailed regulation and extensive regulatory control mechanisms are put in place. (73) Where, on 3 September 2009, an undertaking owning a transmission system was part of a vertically integrated undertaking, Member States should be given a choice between ownership unbundling and setting up a system operator or transmission operator which is independent from supply and generation interests. (74) To preserve fully the interests of the shareholders of vertically integrated undertakings, Member States should have the choice of implementing ownership unbundling either by direct divestments or by splitting the shares of the integrated undertaking into shares of a network undertaking and shares of a remaining supply and generation undertaking, provided that the requirements resulting from ownership unbundling are complied with. (75) The full effectiveness of the independent system operator or independent transmission operator solutions should be ensured by way of specific additional rules. The rules on independent transmission operators provide an appropriate regulatory framework to guarantee fair competition, sufficient investment, access for new market entrants and integration of electricity markets. Effective unbundling through provisions on independent transmission operators should be based on a pillar of organisational measures and measures relating to the governance of transmission system operators and on a pillar of measures relating to investment, to connecting new production capacities to the network and to market integration through regional cooperation. The independence of transmission operators should also be ensured, inter alia, through certain \u2018cooling-off\u2019 periods during which no management or other relevant activity giving access to the same information that could have been obtained in a managerial position is exercised in the vertically integrated undertaking. (76) Member States have the right to opt for full ownership unbundling in their territory. Where a Member State has exercised that right, an undertaking does not have the right to set up an independent system operator or an independent transmission operator. Furthermore, an undertaking performing any of the functions of generation or supply cannot directly or indirectly exercise control or any right over a transmission system operator from a Member State that has opted for full ownership unbundling. (77) The implementation of effective unbundling should respect the principle of non-discrimination between the public and private sectors. To that end, the same person should not be able to exercise control or any right, in violation of the rules of ownership unbundling or the independent system operator option, solely or jointly, over the composition, voting or decisions of both the bodies of the transmission system operators or the transmission systems and the bodies of the producer or supplier. With regard to ownership unbundling and the independent system operator solution, provided that the relevant Member State is able to demonstrate that the relevant requirements have been complied with, two separate public bodies should be able to control generation and supply activities, on the one hand, and transmission activities, on the other. (78) Fully effective separation of network activities from supply and generation activities should apply throughout the Union to both Union and non-Union undertakings. To ensure that network activities and supply and generation activities throughout the Union remain independent from each other, regulatory authorities should be empowered to refuse to certify transmission system operators that do not comply with the unbundling rules. To ensure the consistent application of those rules across the Union, the regulatory authorities should take the utmost account of Commission opinions when they take decisions on certification. In addition, to ensure respect for the international obligations of the Union, and to ensure solidarity and energy security within the Union, the Commission should have the right to give an opinion on certification in relation to a transmission system owner or a transmission system operator which is controlled by a person or persons from a third country or third countries. (79) Authorisation procedures should not lead to administrative burdens that are disproportionate to the size and potential impact of the producers. Unduly lengthy authorisation procedures may constitute a barrier to access for new market entrants. (80) Regulatory authorities need to be able to take decisions in relation to all relevant regulatory issues if the internal market for electricity is to function properly, and need to be fully independent from any other public or private interests. This precludes neither judicial review nor parliamentary supervision in accordance with the constitutional laws of the Member States. In addition, the approval of the budget of the regulatory authority by the national legislator does not constitute an obstacle to budgetary autonomy. The provisions relating to the autonomy in the implementation of the allocated budget of the regulatory authority should be implemented in the framework defined by national budgetary law and rules. While contributing to the regulatory authorities' independence from any political or economic interest through an appropriate rotation scheme, it should be possible for Member States to take due account of the availability of human resources and of the size of the board. (81) Regulatory authorities should be able to fix or approve tariffs, or the methodologies underlying the calculation of the tariffs, on the basis of a proposal by the transmission system operator or distribution system operators, or on the basis of a proposal agreed between those operators and the users of the network. In carrying out those tasks, regulatory authorities should ensure that transmission and distribution tariffs are non-discriminatory and cost-reflective, and should take account of the long-term, marginal, avoided network costs from distributed generation and demand-side management measures. (82) Regulatory authorities should fix or approve individual grid tariffs for transmission and distribution networks or a methodology, or both. In either case, the independence of the regulatory authorities in setting network tariffs pursuant to point (b)(ii) of Article 57(4) should be preserved. (83) Regulatory authorities should ensure that transmission system operators and distribution system operators take appropriate measures to make their network more resilient and flexible. To that end, they should monitor those operators' performance based on indicators such as the capability of transmission system operators and distribution system operators to operate lines under dynamic line rating, the development of remote monitoring and real-time control of substations, the reduction of grid losses and the frequency and duration of power interruptions. (84) Regulatory authorities should have the power to issue binding decisions in relation to electricity undertakings and to impose effective, proportionate and dissuasive penalties on electricity undertakings which fail to comply with their obligations or to propose that a competent court impose such penalties on them. To that end, regulatory authorities should be able to request relevant information from electricity undertakings, to conduct appropriate and sufficient investigations, and to settle disputes. Regulatory authorities should also be granted the power to decide, irrespective of the application of competition rules, on appropriate measures that ensure customer benefits through the promotion of effective competition necessary for the proper functioning of the internal market for electricity. (85) Regulatory authorities should coordinate among themselves when carrying out their tasks to ensure that the European Network of Transmission System Operators for Electricity (the \u2018ENTSO for Electricity\u2019), the European Entity for Distribution System Operators (the \u2018EU DSO entity\u2019), and the regional coordination centres comply with their obligations under the regulatory framework of the internal market for electricity, and with decisions of the Agency for the Cooperation of Energy Regulators (ACER), established by Regulation (EU) 2019/942 of the European Parliament and of the Council (9). With the expansion of the operational responsibilities of the ENTSO for Electricity, the EU DSO entity and the regional coordination centres, it is necessary to enhance oversight with regard to entities that operate at Union or regional level. Regulatory authorities should consult each other and should coordinate their oversight to jointly identify situations where the ENTSO for Electricity, the EU DSO entity or the regional coordination centres do not comply with their respective obligations. (86) Regulatory authorities should also be granted the power to contribute to ensuring high standards of universal and public service obligations in accordance with market opening, to the protection of vulnerable customers, and to the full effectiveness of consumer protection measures. Those provisions should be without prejudice to both the Commission's powers concerning the application of competition rules, including the examination of mergers with a Union dimension, and the rules on the internal market, such as the rules on the free movement of capital. The independent body to which a party affected by the decision of a regulatory authority has a right to appeal could be a court or another tribunal that is empowered to conduct a judicial review. (87) This Directive and Directive 2009/73/EC of the European Parliament and of the Council (10) do not deprive Member States of the possibility of establishing and issuing their national energy policy. It follows that, depending on a Member State's constitutional arrangements, it might be within Member State's competence to determine the policy framework in which the regulatory authorities are to operate, for example concerning security of supply. However, the general energy policy guidelines issued by the Member State should not impinge on the independence or autonomy of the regulatory authorities. (88) Regulation (EU) 2019/943 provides for the Commission to adopt guidelines or network codes to achieve the necessary degree of harmonisation. Such guidelines and network codes constitute binding implementing measures and, with regard to certain provisions of this Directive, are a useful tool that can be adapted quickly where necessary. (89) Member States and the Contracting Parties to the Treaty establishing the Energy Community (11) should cooperate closely on all matters concerning the development of an integrated electricity trading region and should take no measures that endanger the further integration of electricity markets or the security of supply of Member States and Contracting Parties. (90) This Directive should be read together with Regulation (EU) 2019/943, which lays down the key principles of the new market design for electricity which will enable better rewards for flexibility, provide adequate price signals, and ensure the development of functioning integrated short-term markets. Regulation (EU) 2019/943 also sets out new rules in various areas, including on capacity mechanisms and cooperation between transmission system operators. (91) This Directive respects the fundamental rights and observes the principles recognised in the Charter. Accordingly, this Directive should be interpreted and applied in accordance with those rights and principles, in particular the right to the protection of personal data guaranteed by Article 8 of the Charter. It is essential that any processing of personal data under this Directive comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (12). (92) In order to provide the minimum degree of harmonisation required to achieve the aim of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to establish rules on the extent of the duties of the regulatory authorities to cooperate with each other and with ACER and setting out the details of the procedure for compliance with the network codes and guidelines. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of the delegated acts. (93) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission to determine interoperability requirements and non-discriminatory and transparent procedures for access to metering data, consumption data, as well as data required for customer switching, demand response and other services. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (14). (94) Where a derogation applies pursuant to Article 66(3), (4) or (5), that derogation should also cover any provisions in this Directive that are ancillary to, or that require the prior application of, any of the provisions from which it has been granted a derogation. (95) The provisions of Directive 2012/27/EU related to electricity markets, such as the provisions on metering and billing of electricity, demand response, priority dispatch and grid access for high-efficiency cogeneration, are updated by the provisions laid down in this Directive and in Regulation (EU) 2019/943. Directive 2012/27/EU should therefore be amended accordingly. (96) Since the objective of this Directive, namely the creation of a fully operational internal market for electricity, cannot be sufficiently achieved by the Member States but can rather, by the reasons of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (97) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (15), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (98) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to Directive 2009/72/EC. The obligation to transpose the provisions which are unchanged arises under Directive 2009/72/EC. (99) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law and the date of application of Directive 2009/72/EC set out in Annex III, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I SUBJECT MATTER AND DEFINITIONS Article 1 Subject matter This Directive establishes common rules for the generation, transmission, distribution, energy storage and supply of electricity, together with consumer protection provisions, with a view to creating truly integrated competitive, consumer-centred, flexible, fair and transparent electricity markets in the Union. Using the advantages of an integrated market, this Directive aims to ensure affordable, transparent energy prices and costs for consumers, a high degree of security of supply and a smooth transition towards a sustainable low-carbon energy system. It lays down key rules relating to the organisation and functioning of the Union electricity sector, in particular rules on consumer empowerment and protection, on open access to the integrated market, on third-party access to transmission and distribution infrastructure, unbundling requirements, and rules on the independence of regulatory authorities in the Member States. This Directive also sets out modes for Member States, regulatory authorities and transmission system operators to cooperate towards the creation of a fully interconnected internal market for electricity that increases the integration of electricity from renewable sources, free competition and security of supply. Article 2 Definitions For the purposes of this Directive, the following definitions apply: (1) \u2018customer\u2019 means a wholesale or final customer of electricity; (2) \u2018wholesale customer\u2019 means a natural or legal person who purchases electricity for the purpose of resale inside or outside the system where that person is established; (3) \u2018final customer\u2019 means a customer who purchases electricity for own use; (4) \u2018household customer\u2019 means a customer who purchases electricity for the customer's own household consumption, excluding commercial or professional activities; (5) \u2018non-household customer\u2019 means a natural or legal person who purchases electricity that is not for own household use, including producers, industrial customers, small and medium-sized enterprises, businesses and wholesale customers; (6) \u2018microenterprise\u2019 means an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million; (7) \u2018small enterprise\u2019 means an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million; (8) \u2018active customer\u2019 means a final customer, or a group of jointly acting final customers, who consumes or stores electricity generated within its premises located within confined boundaries or, where permitted by a Member State, within other premises, or who sells self-generated electricity or participates in flexibility or energy efficiency schemes, provided that those activities do not constitute its primary commercial or professional activity; (9) \u2018electricity markets\u2019 means markets for electricity, including over-the-counter markets and electricity exchanges, markets for the trading of energy, capacity, balancing and ancillary services in all timeframes, including forward, day-ahead and intraday markets; (10) \u2018market participant\u2019 means market participant as defined in point (25) of Article 2 of Regulation (EU) 2019/943; (11) \u2018citizen energy community\u2019 means a legal entity that: (a) is based on voluntary and open participation and is effectively controlled by members or shareholders that are natural persons, local authorities, including municipalities, or small enterprises; (b) has for its primary purpose to provide environmental, economic or social community benefits to its members or shareholders or to the local areas where it operates rather than to generate financial profits; and (c) may engage in generation, including from renewable sources, distribution, supply, consumption, aggregation, energy storage, energy efficiency services or charging services for electric vehicles or provide other energy services to its members or shareholders; (12) \u2018supply\u2019 means the sale, including the resale, of electricity to customers; (13) \u2018electricity supply contract\u2019 means a contract for the supply of electricity, but does not include electricity derivatives; (14) \u2018electricity derivative\u2019 means a financial instrument specified in point (5), (6) or (7) of Section C of Annex I to Directive 2014/65/EU of the European Parliament and of the Council (16), where that instrument relates to electricity; (15) \u2018dynamic electricity price contract\u2019 means an electricity supply contract between a supplier and a final customer that reflects the price variation in the spot markets, including in the day-ahead and intraday markets, at intervals at least equal to the market settlement frequency; (16) \u2018contract termination fee\u2019 means a charge or penalty imposed on customers by suppliers or market participants engaged in aggregation, for terminating an electricity supply or service contract; (17) \u2018switching-related fee\u2019 means a charge or penalty for changing suppliers or market participants engaged in aggregation, including contract termination fees, that is directly or indirectly imposed on customers by suppliers, market participants engaged in aggregation or system operators; (18) \u2018aggregation\u2019 means a function performed by a natural or legal person who combines multiple customer loads or generated electricity for sale, purchase or auction in any electricity market; (19) \u2018independent aggregator\u2019 means a market participant engaged in aggregation who is not affiliated to the customer's supplier; (20) \u2018demand response\u2019 means the change of electricity load by final customers from their normal or current consumption patterns in response to market signals, including in response to time-variable electricity prices or incentive payments, or in response to the acceptance of the final customer's bid to sell demand reduction or increase at a price in an organised market as defined in point (4) of Article 2 of Commission Implementing Regulation (EU) No 1348/2014 (17), whether alone or through aggregation; (21) \u2018billing information\u2019 means the information provided on a final customer's bill, apart from a request for payment; (22) \u2018conventional meter\u2019 means an analogue or electronic meter with no capability to both transmit and receive data; (23) \u2018smart metering system\u2019 means an electronic system that is capable of measuring electricity fed into the grid or electricity consumed from the grid, providing more information than a conventional meter, and that is capable of transmitting and receiving data for information, monitoring and control purposes, using a form of electronic communication; (24) \u2018interoperability\u2019 means, in the context of smart metering, the ability of two or more energy or communication networks, systems, devices, applications or components to interwork to exchange and use information in order to perform required functions; (25) \u2018imbalance settlement period\u2019 means imbalance settlement period as defined in point (15) of Article 2 of Regulation (EU) 2019/943; (26) \u2018near real-time\u2019 means, in the context of smart metering, a short time period, usually down to seconds or up to the imbalance settlement period in the national market; (27) \u2018best available techniques\u2019 means, in the context of data protection and security in a smart metering environment, the most effective, advanced and practically suitable techniques for providing, in principle, the basis for complying with the Union data protection and security rules; (28) \u2018distribution\u2019 means the transport of electricity on high-voltage, medium-voltage and low-voltage distribution systems with a view to its delivery to customers, but does not include supply; (29) \u2018distribution system operator\u2019 means a natural or legal person who is responsible for operating, ensuring the maintenance of and, if necessary, developing the distribution system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the distribution of electricity; (30) \u2018energy efficiency\u2019 means the ratio of output of performance, service, goods or energy, to input of energy; (31) \u2018energy from renewable sources\u2019 or \u2018renewable energy\u2019 means energy from renewable non-fossil sources, namely wind, solar (solar thermal and solar photovoltaic) and geothermal energy, ambient energy, tide, wave and other ocean energy, hydropower, biomass, landfill gas, sewage treatment plant gas, and biogas; (32) \u2018distributed generation\u2019 means generating installations connected to the distribution system; (33) \u2018recharging point\u2019 means an interface that is capable of charging one electric vehicle at a time or exchanging the battery of one electric vehicle at a time; (34) \u2018transmission\u2019 means the transport of electricity on the extra high-voltage and high-voltage interconnected system with a view to its delivery to final customers or to distributors, but does not include supply; (35) \u2018transmission system operator\u2019 means a natural or legal person who is responsible for operating, ensuring the maintenance of and, if necessary, developing the transmission system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the transmission of electricity; (36) \u2018system user\u2019 means a natural or legal person who supplies to, or is supplied by, a transmission system or a distribution system; (37) \u2018generation\u2019 means the production of electricity; (38) \u2018producer\u2019 means a natural or legal person who generates electricity; (39) \u2018interconnector\u2019 means equipment used to link electricity systems; (40) \u2018interconnected system\u2019 means a number of transmission and distribution systems linked together by means of one or more interconnectors; (41) \u2018direct line\u2019 means either an electricity line linking an isolated generation site with an isolated customer or an electricity line linking a producer and an electricity supply undertaking to supply directly their own premises, subsidiaries and customers; (42) \u2018small isolated system\u2019 means any system that had consumption of less than 3 000 GWh in the year 1996, where less than 5 % of annual consumption is obtained through interconnection with other systems; (43) \u2018small connected system\u2019 means any system that had consumption of less than 3 000 GWh in the year 1996, where more than 5 % of annual consumption is obtained through interconnection with other systems; (44) \u2018congestion\u2019 means congestion as defined in point (4) of Article 2 of Regulation (EU) 2019/943; (45) \u2018balancing\u2019 means balancing as defined in point (10) of Article 2 of Regulation (EU) 2019/943; (46) \u2018balancing energy\u2019 means balancing energy as defined in point (11) of Article 2 of Regulation (EU) 2019/943; (47) \u2018balance responsible party\u2019 means balance responsible party as defined in point (14) of Article 2 of Regulation (EU) 2019/943; (48) \u2018ancillary service\u2019 means a service necessary for the operation of a transmission or distribution system, including balancing and non-frequency ancillary services, but not including congestion management; (49) \u2018non-frequency ancillary service\u2019 means a service used by a transmission system operator or distribution system operator for steady state voltage control, fast reactive current injections, inertia for local grid stability, short-circuit current, black start capability and island operation capability; (50) \u2018regional coordination centre\u2019 means a regional coordination centre established pursuant to Article 35 of Regulation (EU) 2019/943; (51) \u2018fully integrated network components\u2019 means network components that are integrated in the transmission or distribution system, including storage facilities, and that are used for the sole purpose of ensuring a secure and reliable operation of the transmission or distribution system, and not for balancing or congestion management; (52) \u2018integrated electricity undertaking\u2019 means a vertically integrated undertaking or a horizontally integrated undertaking; (53) \u2018vertically integrated undertaking\u2019 means an electricity undertaking or a group of electricity undertakings where the same person or the same persons are entitled, directly or indirectly, to exercise control, and where the undertaking or group of undertakings performs at least one of the functions of transmission or distribution, and at least one of the functions of generation or supply; (54) \u2018horizontally integrated undertaking\u2019 means an electricity undertaking performing at least one of the functions of generation for sale, or transmission, or distribution, or supply, and another non-electricity activity; (55) \u2018related undertaking\u2019 means affiliated undertakings as defined in point (12) of Article 2 of Directive 2013/34/EU of the European Parliament and of the Council (18), and undertakings which belong to the same shareholders; (56) \u2018control\u2019 means rights, contracts or other means which, either separately or in combination and having regard to the considerations of fact or law involved, confer the possibility of exercising decisive influence on an undertaking, in particular by: (a) ownership or the right to use all or part of the assets of an undertaking; (b) rights or contracts which confer decisive influence on the composition, voting or decisions of the organs of an undertaking; (57) \u2018electricity undertaking\u2019 means a natural or legal person who carries out at least one of the following functions: generation, transmission, distribution, aggregation, demand response, energy storage, supply or purchase of electricity, and who is responsible for the commercial, technical or maintenance tasks related to those functions, but does not include final customers; (58) \u2018security\u2019 means both security of supply and provision of electricity, and technical safety; (59) \u2018energy storage\u2019 means, in the electricity system, deferring the final use of electricity to a moment later than when it was generated, or the conversion of electrical energy into a form of energy which can be stored, the storing of such energy, and the subsequent reconversion of such energy into electrical energy or use as another energy carrier; (60) \u2018energy storage facility\u2019 means, in the electricity system, a facility where energy storage occurs. CHAPTER II GENERAL RULES FOR THE ORGANISATION OF THE ELECTRICITY SECTOR Article 3 Competitive, consumer-centred, flexible and non-discriminatory electricity markets 1. Member States shall ensure that their national law does not unduly hamper cross-border trade in electricity, consumer participation, including through demand response, investments into, in particular, variable and flexible energy generation, energy storage, or the deployment of electromobility or new interconnectors between Member States, and shall ensure that electricity prices reflect actual demand and supply. 2. When developing new interconnectors, Member States shall take into account the electricity interconnection targets set out in point (1) of Article 4(d) of Regulation (EU) 2018/1999. 3. Member States shall ensure that no undue barriers exist within the internal market for electricity as regards market entry, operation and exit, without prejudice to the competence that Member States retain in relation to third countries. 4. Member States shall ensure a level playing field where electricity undertakings are subject to transparent, proportionate and non-discriminatory rules, fees and treatment, in particular with respect to balancing responsibility, access to wholesale markets, access to data, switching processes and billing regimes and, where applicable, licensing. 5. Member States shall ensure that market participants from third countries, when operating within the internal market for electricity, comply with applicable Union and national law, including that concerning environmental and safety policy. Article 4 Free choice of supplier Member States shall ensure that all customers are free to purchase electricity from the supplier of their choice and shall ensure that all customers are free to have more than one electricity supply contract at the same time, provided that the required connection and metering points are established. Article 5 Market-based supply prices 1. Suppliers shall be free to determine the price at which they supply electricity to customers. Member States shall take appropriate actions to ensure effective competition between suppliers. 2. Member States shall ensure the protection of energy poor and vulnerable household customers pursuant to Articles 28 and 29 by social policy or by other means than public interventions in the price setting for the supply of electricity. 3. By way of derogation from paragraphs 1 and 2, Member States may apply public interventions in the price setting for the supply of electricity to energy poor or vulnerable household customers. Such public interventions shall be subject to the conditions set out in paragraphs 4 and 5. 4. Public interventions in the price setting for the supply of electricity shall: (a) pursue a general economic interest and not go beyond what is necessary to achieve that general economic interest; (b) be clearly defined, transparent, non-discriminatory and verifiable; (c) guarantee equal access for Union electricity undertakings to customers; (d) be limited in time and proportionate as regards their beneficiaries; (e) not result in additional costs for market participants in a discriminatory way. 5. Any Member State applying public interventions in the price setting for the supply of electricity in accordance with paragraph 3 of this Article shall also comply with point (d) of Article 3(3) and with Article 24 of Regulation (EU) 2018/1999, regardless of whether the Member State concerned has a significant number of households in energy poverty. 6. For the purpose of a transition period to establish effective competition for electricity supply contracts between suppliers, and to achieve fully effective market-based retail pricing of electricity in accordance with paragraph 1, Member States may apply public interventions in the price setting for the supply of electricity to household customers and to microenterprises that do not benefit from public interventions pursuant to paragraph 3. 7. Public interventions pursuant to paragraph 6 shall comply with the criteria set out in paragraph 4 and shall: (a) be accompanied by a set of measures to achieve effective competition and a methodology for assessing progress with regard to those measures; (b) be set using a methodology that ensures non-discriminatory treatment of suppliers; (c) be set at a price that is above cost, at a level where effective price competition can occur; (d) be designed to minimise any negative impact on the wholesale electricity market; (e) ensure that all beneficiaries of such public interventions have the possibility to choose competitive market offers and are directly informed at least every quarter of the availability of offers and savings in the competitive market, in particular of dynamic electricity price contracts, and shall ensure that they are provided with assistance to switch to a market-based offer; (f) ensure that, pursuant to Articles 19 and 21, all beneficiaries of such public interventions are entitled to, and are offered to, have smart meters installed at no extra upfront cost to the customer, are directly informed of the possibility of installing smart meters and are provided with necessary assistance; (g) not lead to direct cross-subsidisation between customers supplied at free market prices and those supplied at regulated supply prices. 8. Member States shall notify the measures taken in accordance with paragraphs 3 and 6 to the Commission within one month after their adoption and may apply them immediately. The notification shall be accompanied by an explanation of why other instruments were not sufficient to achieve the objective pursued, of how the requirements set out in paragraphs 4 and 7 are fulfilled and of the effects of the notified measures on competition. The notification shall describe the scope of the beneficiaries, the duration of the measures and the number of household customers affected by the measures, and shall explain how the regulated prices have been determined. 9. By 1 January 2022 and 1 January 2025, Member States shall submit reports to the Commission on the implementation of this Article, the necessity and proportionality of public interventions under this Article, and an assessment of the progress towards achieving effective competition between suppliers and the transition to market-based prices. Member States that apply regulated prices in accordance with paragraph 6 shall report on the compliance with the conditions set out in paragraph 7, including on compliance by suppliers that are required to apply such interventions, as well as on the impact of regulated prices on the finances of those suppliers. 10. By 31 December 2025, the Commission shall review and submit a report to the European Parliament and to the Council on the implementation of this Article for the purpose of achieving market-based retail pricing of electricity, together with or followed by a legislative proposal, if appropriate. That legislative proposal may include an end date for regulated prices. Article 6 Third-party access 1. Member States shall ensure the implementation of a system of third-party access to the transmission and distribution systems based on published tariffs, applicable to all customers and applied objectively and without discrimination between system users. Member States shall ensure that those tariffs, or the methodologies underlying their calculation, are approved in accordance with Article 59 prior to their entry into force and that those tariffs, and the methodologies \u2014 where only methodologies are approved \u2014 are published prior to their entry into force. 2. The transmission or distribution system operator may refuse access where it lacks the necessary capacity. Duly substantiated reasons shall be given for such refusal, in particular having regard to Article 9, and based on objective and technically and economically justified criteria. Member States or, where Member States have so provided, the regulatory authorities of those Member States, shall ensure that those criteria are consistently applied and that the system user who has been refused access can make use of a dispute settlement procedure. The regulatory authorities shall also ensure, where appropriate and when refusal of access takes place, that the transmission system operator or distribution system operator provides relevant information on measures that would be necessary to reinforce the network. Such information shall be provided in all cases when access for recharging points has been denied. The party requesting such information may be charged a reasonable fee reflecting the cost of providing such information. 3. This Article shall also apply to citizen energy communities that manage distribution networks. Article 7 Direct lines 1. Member States shall take the measures necessary to enable: (a) all producers and electricity supply undertakings established within their territory to supply their own premises, subsidiaries and customers through a direct line, without being subject to disproportionate administrative procedures or costs; (b) all customers within their territory, individually or jointly, to be supplied through a direct line by producers and electricity supply undertakings. 2. Member States shall lay down the criteria for the grant of authorisations for the construction of direct lines in their territory. Those criteria shall be objective and non-discriminatory. 3. The possibility of supplying electricity through a direct line as referred to in paragraph 1 of this Article shall not affect the possibility of contracting electricity in accordance with Article 6. 4. Member States may issue authorisations to construct a direct line, subject either to the refusal of system access on the basis, as appropriate, of Article 6 or to the opening of a dispute settlement procedure under Article 60. 5. Member States may refuse to authorise a direct line if the granting of such an authorisation would obstruct the application of the provisions on public service obligations in Article 9. Duly substantiated reasons shall be given for such a refusal. Article 8 Authorisation procedure for new capacity 1. For the construction of new generating capacity, Member States shall adopt an authorisation procedure, which shall be conducted in accordance with objective, transparent and non-discriminatory criteria. 2. Member States shall lay down the criteria for the grant of authorisations for the construction of generating capacity in their territory. In determining appropriate criteria, Member States shall consider: (a) the safety and security of the electricity system, installations and associated equipment; (b) the protection of public health and safety; (c) the protection of the environment; (d) land use and siting; (e) the use of public ground; (f) energy efficiency; (g) the nature of the primary sources; (h) the characteristics particular to the applicant, such as technical, economic and financial capabilities; (i) compliance with measures adopted pursuant to Article 9; (j) the contribution of generating capacity to meeting the overall Union target of at least a 32 % share of energy from renewable sources in the Union's gross final consumption of energy in 2030 referred to in Article 3(1) of Directive (EU) 2018/2001 of the European Parliament and of the Council (19); (k) the contribution of generating capacity to reducing emissions; and (l) the alternatives to the construction of new generating capacity, such as demand response solutions and energy storage. 3. Member States shall ensure that specific, simplified and streamlined authorisation procedures exist for small decentralised and/or distributed generation, which take into account their limited size and potential impact. Member States may set guidelines for that specific authorisation procedure. Regulatory authorities or other competent national authorities, including planning authorities, shall review those guidelines and may recommend amendments thereto. Where Member States have established particular land use permit procedures applying to major new infrastructure projects in generation capacity, Member States shall, where appropriate, include the construction of new generation capacity within the scope of those procedures and shall implement them in a non-discriminatory manner and within an appropriate time frame. 4. The authorisation procedures and criteria shall be made public. Applicants shall be informed of the reasons for any refusal to grant an authorisation. Those reasons shall be objective, non-discriminatory, well-founded and duly substantiated. Appeal procedures shall be made available to applicants. Article 9 Public service obligations 1. Without prejudice to paragraph 2, Member States shall ensure, on the basis of their institutional organisation and with due regard to the principle of subsidiarity, that electricity undertakings operate in accordance with the principles of this Directive with a view to achieving a competitive, secure and environmentally sustainable market for electricity, and shall not discriminate between those undertakings as regards either rights or obligations. 2. Having full regard to the relevant provisions of the TFEU, in particular Article 106 thereof, Member States may impose on undertakings operating in the electricity sector, in the general economic interest, public service obligations which may relate to security, including the security of supply, regularity, quality and price of supplies and environmental protection, including energy efficiency, energy from renewable sources and climate protection. Such obligations shall be clearly defined, transparent, non-discriminatory and verifiable, and shall guarantee equality of access for electricity undertakings of the Union to national consumers. Public service obligations which concern the price setting for the supply of electricity shall comply with the requirements set out in Article 5 of this Directive. 3. Where financial compensation, other forms of compensation and exclusive rights which a Member State grants for the fulfilment of the obligations set out in paragraph 2 of this Article or for the provision of universal service as set out in Article 27 are provided, this shall be done in a non-discriminatory and transparent way. 4. Member States shall, upon implementation of this Directive, inform the Commission of all measures adopted to fulfil universal service and public service obligations, including consumer protection and environmental protection, and their possible effect on national and international competition, whether or not such measures require a derogation from this Directive. They shall subsequently inform the Commission every two years of any changes to those measures, whether or not they require a derogation from this Directive. 5. Member States may decide not to apply Articles 6, 7 and 8 of this Directive insofar as their application would obstruct, in law or in fact, the performance of the obligations imposed on electricity undertakings in the general economic interest and insofar as the development of trade would not be affected to such an extent as would be contrary to the interests of the Union. The interests of the Union include, inter alia, competition with regard to customers in accordance with Article 106 TFEU and this Directive. CHAPTER III CONSUMER EMPOWERMENT AND PROTECTION Article 10 Basic contractual rights 1. Member States shall ensure that all final customers are entitled to have their electricity provided by a supplier, subject to the supplier's agreement, regardless of the Member State in which the supplier is registered, provided that the supplier follows the applicable trading and balancing rules. In that regard, Member States shall take all measures necessary to ensure that administrative procedures do not discriminate against suppliers already registered in another Member State. 2. Without prejudice to Union rules on consumer protection, in particular Directive 2011/83/EU of the European Parliament and of the Council (20) and Council Directive 93/13/EEC (21), Member States shall ensure that final customers have the rights provided for in paragraphs 3 to 12 of this Article. 3. Final customers shall have the right to a contract with their supplier that specifies: (a) the identity and address of the supplier; (b) the services provided, the service quality levels offered, as well as the time for the initial connection; (c) the types of maintenance service offered; (d) the means by which up-to-date information on all applicable tariffs, maintenance charges and bundled products or services may be obtained; (e) the duration of the contract, the conditions for renewal and termination of the contract and services, including products or services that are bundled with those services, and whether terminating the contract without charge is permitted; (f) any compensation and the refund arrangements which apply if contracted service quality levels are not met, including inaccurate or delayed billing; (g) the method of initiating an out-of-court dispute settlement procedure in accordance with Article 26; (h) information relating to consumer rights, including information on complaint handling and all of the information referred to in this paragraph, that is clearly communicated on the bill or the electricity undertaking's web site. Conditions shall be fair and well known in advance. In any case, this information shall be provided prior to the conclusion or confirmation of the contract. Where contracts are concluded through intermediaries, the information relating to the matters set out in this paragraph shall also be provided prior to the conclusion of the contract. Final customers shall be provided with a summary of the key contractual conditions in a prominent manner and in concise and simple language. 4. Final customers shall be given adequate notice of any intention to modify contractual conditions and shall be informed about their right to terminate the contract when the notice is given. Suppliers shall notify their final customers, in a transparent and comprehensible manner, directly of any adjustment in the supply price and of the reasons and preconditions for the adjustment and its scope, at an appropriate time no later than two weeks, or no later than one month in the case of household customers, before the adjustment comes into effect. Member States shall ensure that final customers are free to terminate contracts if they do not accept the new contractual conditions or adjustments in the supply price notified to them by their supplier. 5. Suppliers shall provide final customers with transparent information on applicable prices and tariffs and on standard terms and conditions, in respect of access to and use of electricity services. 6. Suppliers shall offer final customers a wide choice of payment methods. Such payment methods shall not unduly discriminate between customers. Any difference in charges related to payment methods or prepayment systems shall be objective, non-discriminatory and proportionate and shall not exceed the direct costs borne by the payee for the use of a specific payment method or a prepayment system, in line with Article 62 of Directive (EU) 2015/2366 of the European Parliament and of the Council (22). 7. Pursuant to paragraph 6, household customers who have access to prepayment systems shall not be placed at a disadvantage by the prepayment systems. 8. Suppliers shall offer final customers fair and transparent general terms and conditions, which shall be provided in plain and unambiguous language and shall not include non-contractual barriers to the exercise of customers' rights, such as excessive contractual documentation. Customers shall be protected against unfair or misleading selling methods. 9. Final customers shall have the right to a good standard of service and complaint handling by their suppliers. Suppliers shall handle complaints in a simple, fair and prompt manner. 10. When accessing universal service under the provisions adopted by Member States pursuant to Article 27, final customers shall be informed about their rights regarding universal service. 11. Suppliers shall provide household customers with adequate information on alternative measures to disconnection sufficiently in advance of any planned disconnection. Such alternative measures may refer to sources of support to avoid disconnection, prepayment systems, energy audits, energy consultancy services, alternative payment plans, debt management advice or disconnection moratoria and not constitute an extra cost to the customers facing disconnection. 12. Suppliers shall provide final customers with a final closure account after any switch of supplier no later than six weeks after such a switch has taken place. Article 11 Entitlement to a dynamic electricity price contract 1. Member States shall ensure that the national regulatory framework enables suppliers to offer dynamic electricity price contracts. Member States shall ensure that final customers who have a smart meter installed can request to conclude a dynamic electricity price contract with at least one supplier and with every supplier that has more than 200 000 final customers. 2. Member States shall ensure that final customers are fully informed by the suppliers of the opportunities, costs and risks of such dynamic electricity price contracts, and shall ensure that suppliers are required to provide information to the final customers accordingly, including with regard to the need to have an adequate electricity meter installed. Regulatory authorities shall monitor the market developments and assess the risks that the new products and services may entail and deal with abusive practices. 3. Suppliers shall obtain each final customer's consent before that customer is switched to a dynamic electricity price contract. 4. For at least a ten-year period after dynamic electricity price contracts become available, Member States or their regulatory authorities shall monitor, and shall publish an annual report on the main developments of such contracts, including market offers and the impact on consumers' bills, and specifically the level of price volatility. Article 12 Right to switch and rules on switching-related fees 1. Switching supplier or market participant engaged in aggregation shall be carried out within the shortest possible time. Member States shall ensure that a customer wishing to switch suppliers or market participants engaged in aggregation, while respecting contractual conditions, is entitled to such a switch within a maximum of three weeks from the date of the request. By no later than 2026, the technical process of switching supplier shall take no longer than 24 hours and shall be possible on any working day. 2. Member States shall ensure that at least household customers and small enterprises are not charged any switching-related fees. 3. By way of derogation from paragraph 2, Member States may permit suppliers or market participants engaged in aggregation to charge customers contract termination fees where those customers voluntarily terminate fixed-term, fixed-price electricity supply contracts before their maturity, provided that such fees are part of a contract that the customer has voluntarily entered into and that such fees are clearly communicated to the customer before the contract is entered into. Such fees shall be proportionate and shall not exceed the direct economic loss to the supplier or the market participant engaged in aggregation resulting from the customer's termination of the contract, including the costs of any bundled investments or services that have already been provided to the customer as part of the contract. The burden of proving the direct economic loss shall be on the supplier or market participant engaged in aggregation, and the permissibility of contract termination fees shall be monitored by the regulatory authority, or by an other competent national authority. 4. Member States shall ensure that the right to switch supplier or market participants engaged in aggregation is granted to customers in a non-discriminatory manner as regards cost, effort and time. 5. Household customers shall be entitled to participate in collective switching schemes. Member States shall remove all regulatory or administrative barriers for collective switching, while providing a framework that ensures the utmost consumer protection to avoid any abusive practices. Article 13 Aggregation contract 1. Member States shall ensure that all customers are free to purchase and sell electricity services, including aggregation, other than supply, independently from their electricity supply contract and from an electricity undertaking of their choice. 2. Member States shall ensure that, where a final customer wishes to conclude an aggregation contract, the final customer is entitled to do so without the consent of the final customer's electricity undertakings. Member States shall ensure that market participants engaged in aggregation fully inform customers of the terms and conditions of the contracts that they offer to them. 3. Member States shall ensure that final customers are entitled to receive all relevant demand response data or data on supplied and sold electricity free of charge at least once every billing period if requested by the customer. 4. Member States shall ensure that the rights referred to in paragraphs 2 and 3 are granted to final customers in a non-discriminatory manner as regards cost, effort or time. In particular, Member States shall ensure that customers are not subject to discriminatory technical and administrative requirements, procedures or charges by their supplier on the basis of whether they have a contract with a market participant engaged in aggregation. Article 14 Comparison tools 1. Member States shall ensure that at least household customers, and microenterprises with an expected yearly consumption of below 100 000 kWh, have access, free of charge, to at least one tool comparing the offers of suppliers, including offers for dynamic electricity price contracts. Customers shall be informed of the availability of such tools in or together with their bills or by other means. The tools shall meet at least the following requirements: (a) they shall be independent from market participants and ensure that electricity undertakings are given equal treatment in search results; (b) they shall clearly disclose their owners and the natural or legal person operating and controlling the tools, as well as information on how the tools are financed; (c) they shall set out clear and objective criteria on which the comparison is to be based, including services, and disclose them; (d) they shall use plain and unambiguous language; (e) they shall provide accurate and up-to-date information and state the time of the last update; (f) they shall be accessible to persons with disabilities, by being perceivable, operable, understandable and robust; (g) they shall provide an effective procedure for reporting incorrect information on published offers; and (h) they shall perform comparisons, while limiting the personal data requested to that strictly necessary for the comparison. Member States shall ensure that at least one tool covers the entire market. Where multiple tools cover the market, those tools shall include, as complete as practicable, a range of electricity offers covering a significant part of the market and, where those tools do not completely cover the market, a clear statement to that effect, before displaying results. 2. The tools referred to in paragraph 1 may be operated by any entity, including private companies and public authorities or bodies. 3. Member States shall appoint a competent authority to be responsible for issuing trust marks for comparison tools that meet the requirements set out in paragraph 1, and for ensuring that comparison tools bearing a trust mark continue to meet the requirements set out in paragraph 1. That authority shall be independent of any market participants and comparison tool operators. 4. Member States may require comparison tools referred to in paragraph 1 to include comparative criteria relating to the nature of the services offered by the suppliers. 5. Any tool comparing the offers of market participants shall be eligible to apply for a trust mark in accordance with this Article on a voluntary and non-discriminatory basis. 6. By way of derogation from paragraphs 3 and 5, Member States may choose not to provide for the issuance of trust marks to comparison tools if a public authority or body provides a comparison tool that meets the requirements set out in paragraph 1. Article 15 Active customers 1. Member States shall ensure that final customers are entitled to act as active customers without being subject to disproportionate or discriminatory technical requirements, administrative requirements, procedures and charges, and to network charges that are not cost-reflective. 2. Member States shall ensure that active customers are: (a) entitled to operate either directly or through aggregation; (b) entitled to sell self-generated electricity, including through power purchase agreements; (c) entitled to participate in flexibility schemes and energy efficiency schemes; (d) entitled to delegate to a third party the management of the installations required for their activities, including installation, operation, data handling and maintenance, without that third party being considered to be an active customer; (e) subject to cost-reflective, transparent and non-discriminatory network charges that account separately for the electricity fed into the grid and the electricity consumed from the grid, in accordance with Article 59(9) of this Directive and Article 18 of Regulation (EU) 2019/943, ensuring that they contribute in an adequate and balanced way to the overall cost sharing of the system; (f) financially responsible for the imbalances they cause in the electricity system; to that extent they shall be balance responsible parties or shall delegate their balancing responsibility in accordance with Article 5 of Regulation (EU) 2019/943. 3. Member States may have different provisions applicable to individual and jointly-acting active customers in their national law, provided that all rights and obligations under this Article apply to all active customers. Any difference in the treatment of jointly-acting active customers shall be proportionate and duly justified. 4. Member States that have existing schemes that do not account separately for the electricity fed into the grid and the electricity consumed from the grid, shall not grant new rights under such schemes after 31 December 2023. In any event, customers subject to existing schemes shall have the possibility at any time to opt for a new scheme that accounts separately for the electricity fed into the grid and the electricity consumed from the grid as the basis for calculating network charges. 5. Member States shall ensure that active customers that own an energy storage facility: (a) have the right to a grid connection within a reasonable time after the request, provided that all necessary conditions, such as balancing responsibility and adequate metering, are fulfilled; (b) are not subject to any double charges, including network charges, for stored electricity remaining within their premises or when providing flexibility services to system operators; (c) are not subject to disproportionate licensing requirements or fees; (d) are allowed to provide several services simultaneously, if technically feasible. Article 16 Citizen energy communities 1. Member States shall provide an enabling regulatory framework for citizen energy communities ensuring that: (a) participation in a citizen energy community is open and voluntary; (b) members or shareholders of a citizen energy community are entitled to leave the community, in which case Article 12 applies; (c) members or shareholders of a citizen energy community do not lose their rights and obligations as household customers or active customers; (d) subject to fair compensation as assessed by the regulatory authority, relevant distribution system operators cooperate with citizen energy communities to facilitate electricity transfers within citizen energy communities; (e) citizen energy communities are subject to non-discriminatory, fair, proportionate and transparent procedures and charges, including with respect to registration and licensing, and to transparent, non-discriminatory and cost-reflective network charges in accordance with Article 18 of Regulation (EU) 2019/943, ensuring that they contribute in an adequate and balanced way to the overall cost sharing of the system. 2. Member States may provide in the enabling regulatory framework that citizen energy communities: (a) are open to cross-border participation; (b) are entitled to own, establish, purchase or lease distribution networks and to autonomously manage them subject to conditions set out in paragraph 4 of this Article; (c) are subject to the exemptions provided for in Article 38(2). 3. Member States shall ensure that citizen energy communities: (a) are able to access all electricity markets, either directly or through aggregation, in a non-discriminatory manner; (b) are treated in a non-discriminatory and proportionate manner with regard to their activities, rights and obligations as final customers, producers, suppliers, distribution system operators or market participants engaged in aggregation; (c) are financially responsible for the imbalances they cause in the electricity system; to that extent they shall be balance responsible parties or shall delegate their balancing responsibility in accordance with Article 5 of Regulation (EU) 2019/943; (d) with regard to consumption of self-generated electricity, citizen energy communities are treated like active customers in accordance with point (e) of Article 15(2); (e) are entitled to arrange within the citizen energy community the sharing of electricity that is produced by the production units owned by the community, subject to other requirements laid down in this Article and subject to the community members retaining their rights and obligations as final customers. For the purposes of point (e) of the first subparagraph, where electricity is shared, this shall be without prejudice to applicable network charges, tariffs and levies, in accordance with a transparent cost-benefit analysis of distributed energy resources developed by the competent national authority. 4. Member States may decide to grant citizen energy communities the right to manage distribution networks in their area of operation and establish the relevant procedures, without prejudice to Chapter IV or to other rules and regulations applying to distribution system operators. If such a right is granted, Member States shall ensure that citizen energy communities: (a) are entitled to conclude an agreement on the operation of their network with the relevant distribution system operator or transmission system operator to which their network is connected; (b) are subject to appropriate network charges at the connection points between their network and the distribution network outside the citizen energy community and that such network charges account separately for the electricity fed into the distribution network and the electricity consumed from the distribution network outside the citizen energy community in accordance with Article 59(7); (c) do not discriminate or harm customers who remain connected to the distribution system. Article 17 Demand response through aggregation 1. Member States shall allow and foster participation of demand response through aggregation. Member States shall allow final customers, including those offering demand response through aggregation, to participate alongside producers in a non-discriminatory manner in all electricity markets. 2. Member States shall ensure that transmission system operators and distribution system operators, when procuring ancillary services, treat market participants engaged in the aggregation of demand response in a non-discriminatory manner alongside producers on the basis of their technical capabilities. 3. Member States shall ensure that their relevant regulatory framework contains at least the following elements: (a) the right for each market participant engaged in aggregation, including independent aggregators, to enter electricity markets without the consent of other market participants; (b) non-discriminatory and transparent rules that clearly assign roles and responsibilities to all electricity undertakings and customers; (c) non-discriminatory and transparent rules and procedures for the exchange of data between market participants engaged in aggregation and other electricity undertakings that ensure easy access to data on equal and non-discriminatory terms while fully protecting commercially sensitive information and customers' personal data; (d) an obligation on market participants engaged in aggregation to be financially responsible for the imbalances that they cause in the electricity system; to that extent they shall be balance responsible parties or shall delegate their balancing responsibility in accordance with Article 5 of Regulation (EU) 2019/943; (e) provision for final customers who have a contract with independent aggregators not to be subject to undue payments, penalties or other undue contractual restrictions by their suppliers; (f) a conflict resolution mechanism between market participants engaged in aggregation and other market participants, including responsibility for imbalances. 4. Member States may require electricity undertakings or participating final customers to pay financial compensation to other market participants or to the market participants' balance responsible parties, if those market participants or balance responsible parties are directly affected by demand response activation. Such financial compensation shall not create a barrier to market entry for market participants engaged in aggregation or a barrier to flexibility. In such cases, the financial compensation shall be strictly limited to covering the resulting costs incurred by the suppliers of participating customers or the suppliers' balance responsible parties during the activation of demand response. The method for calculating compensation may take account of the benefits brought about by the independent aggregators to other market participants and, where it does so, the aggregators or participating customers may be required to contribute to such compensation but only where and to the extent that the benefits to all suppliers, customers and their balance responsible parties do not exceed the direct costs incurred. The calculation method shall be subject to approval by the regulatory authority or by another competent national authority. 5. Member States shall ensure that regulatory authorities or, where their national legal system so requires, transmission system operators and distribution system operators, acting in close cooperation with market participants and final customers, establish the technical requirements for participation of demand response in all electricity markets on the basis of the technical characteristics of those markets and the capabilities of demand response. Such requirements shall cover participation involving aggregated loads. Article 18 Bills and billing information 1. Member States shall ensure that bills and billing information are accurate, easy to understand, clear, concise, user-friendly and presented in a manner that facilitates comparison by final customers. On request, final customers shall receive a clear and understandable explanation of how their bill was derived, especially where bills are not based on actual consumption. 2. Member States shall ensure that final customers receive all their bills and billing information free of charge. 3. Member States shall ensure that final customers are offered the option of electronic bills and billing information and are offered flexible arrangements for the actual payment of the bills. 4. If the contract provides for a future change of the product or price, or a discount, this shall be indicated on the bill together with the date on which the change takes place. 5. Member States shall consult consumer organisations when they consider changes to the requirements for the content of bills. 6. Member States shall ensure that bills and billing information fulfil the minimum requirements set out in Annex I. Article 19 Smart metering systems 1. In order to promote energy efficiency and to empower final customers, Member States or, where a Member State has so provided, the regulatory authority shall strongly recommend that electricity undertakings and other market participants optimise the use of electricity, inter alia, by providing energy management services, developing innovative pricing formulas, and introducing smart metering systems that are interoperable, in particular with consumer energy management systems and with smart grids, in accordance with the applicable Union data protection rules. 2. Member States shall ensure the deployment in their territories of smart metering systems that assist the active participation of customers in the electricity market. Such deployment may be subject to a cost-benefit assessment which shall be undertaken in accordance with the principles laid down in Annex II. 3. Member States that proceed with the deployment of smart metering systems shall adopt and publish the minimum functional and technical requirements for the smart metering systems to be deployed in their territories, in accordance with Article 20 and Annex II. Member States shall ensure the interoperability of those smart metering systems, as well as their ability to provide output for consumer energy management systems. In that respect, Member States shall have due regard to the use of the relevant available standards, including those enabling interoperability, to best practices and to the importance of the development of smart grids and the development of the internal market for electricity. 4. Member States that proceed with the deployment of smart metering systems shall ensure that final customers contribute to the associated costs of the deployment in a transparent and non-discriminatory manner, while taking into account the long-term benefits to the whole value chain. Member States or, where a Member State has so provided, the designated competent authorities, shall regularly monitor such deployment in their territories to track the delivery of benefits to consumers. 5. Where the deployment of smart metering systems has been negatively assessed as a result of the cost-benefit assessment referred to in paragraph 2, Member States shall ensure that this assessment is revised at least every four years, or more frequently, in response to significant changes in the underlying assumptions and in response to technological and market developments. Member States shall notify to the Commission the outcome of their updated cost-benefit assessment as it becomes available. 6. The provisions in this Directive concerning smart metering systems shall apply to future installations and to installations that replace older smart meters. Smart metering systems that have already been installed, or for which the \u2018start of works\u2019 began, before 4 July 2019, may remain in operation over their lifetime but, in the case of smart metering systems that do not meet the requirements of Article 20 and Annex II, shall not remain in operation after 5 July 2031. For the purpose of this paragraph, \u2018start of works\u2019 means either the start of construction works on the investment or the first firm commitment to order equipment or other commitment that makes the investment irreversible, whichever is the first in time. Buying of land and preparatory works such as obtaining permits and conducting preliminary feasibility studies are not considered as start of works. For take-overs, \u2018start of works\u2019 means the moment of acquiring the assets directly linked to the acquired establishment. Article 20 Functionalities of smart metering systems Where the deployment of smart metering systems is positively assessed as a result of the cost-benefit assessment referred to in Article 19(2), or where smart metering systems are systematically deployed after 4 July 2019, Member States shall deploy smart metering systems in accordance with European standards, Annex II and the following requirements: (a) the smart metering systems shall accurately measure actual electricity consumption and shall be capable of providing to final customers information on actual time of use. Validated historical consumption data shall be made easily and securely available and visualised to final customers on request and at no additional cost. Non-validated near real-time consumption data shall also be made easily and securely available to final customers at no additional cost, through a standardised interface or through remote access, in order to support automated energy efficiency programmes, demand response and other services; (b) the security of the smart metering systems and data communication shall comply with relevant Union security rules, having due regard of the best available techniques for ensuring the highest level of cybersecurity protection while bearing in mind the costs and the principle of proportionality; (c) the privacy of final customers and the protection of their data shall comply with relevant Union data protection and privacy rules; (d) meter operators shall ensure that the meters of active customers who feed electricity into the grid can account for electricity fed into the grid from the active customers' premises; (e) if final customers request it, data on the electricity they fed into the grid and their electricity consumption data shall be made available to them, in accordance with the implementing acts adopted pursuant to Article 24, through a standardised communication interface or through remote access, or to a third party acting on their behalf, in an easily understandable format allowing them to compare offers on a like-for-like basis; (f) appropriate advice and information shall be given to final customers prior to or at the time of installation of smart meters, in particular concerning their full potential with regard to the management of meter reading and the monitoring of energy consumption, and concerning the collection and processing of personal data in accordance with the applicable Union data protection rules; (g) smart metering systems shall enable final customers to be metered and settled at the same time resolution as the imbalance settlement period in the national market. For the purposes of point (e) of the first subparagraph, it shall be possible for final customers to retrieve their metering data or transmit them to another party at no additional cost and in accordance with their right to data portability under Union data protection rules. Article 21 Entitlement to a smart meter 1. Where the deployment of smart metering systems has been negatively assessed as a result of the cost-benefit assessment referred to in Article 19(2) and where smart metering systems are not systematically deployed, Member States shall ensure that every final customer is entitled on request, while bearing the associated costs, to have installed or, where applicable, to have upgraded, under fair, reasonable and cost-effective conditions, a smart meter that: (a) is equipped, where technically feasible, with the functionalities referred to in Article 20, or with a minimum set of functionalities to be defined and published by Member States at national level in accordance with Annex II; (b) is interoperable and able to deliver the desired connectivity of the metering infrastructure with consumer energy management systems in near real-time. 2. In the context of a customer request for a smart meter pursuant to paragraph 1, Member States or, where a Member State has so provided, the designated competent authorities shall: (a) ensure that the offer to the final customer requesting the installation of a smart meter explicitly states and clearly describes: (i) the functions and interoperability that can be supported by the smart meter and the services that are feasible as well as the benefits that can be realistically attained by having that smart meter at that moment in time; (ii) any associated costs to be borne by the final customer; (b) ensure that it is installed within a reasonable time, no later than four months after the customer's request; (c) regularly, and at least every two years, review and make publicly available the associated costs, and trace the evolution of those costs as a result of technology developments and potential metering system upgrades. Article 22 Conventional meters 1. Where final customers do not have smart meters, Member States shall ensure that final customers are provided with individual conventional meters that accurately measure their actual consumption. 2. Member States shall ensure that final customers are able to easily read their conventional meters, either directly or indirectly through an online interface or through another appropriate interface. Article 23 Data management 1. When laying down the rules regarding the management and exchange of data, Member States or, where a Member State has so provided, the designated competent authorities shall specify the rules on the access to data of the final customer by eligible parties in accordance with this Article and the applicable Union legal framework. For the purpose of this Directive, data shall be understood to include metering and consumption data as well as data required for customer switching, demand response and other services. 2. Member States shall organise the management of data in order to ensure efficient and secure data access and exchange, as well as data protection and data security. Independently of the data management model applied in each Member State, the parties responsible for data management shall provide access to the data of the final customer to any eligible party, in accordance with paragraph 1. Eligible parties shall have the requested data at their disposal in a non-discriminatory manner and simultaneously. Access to data shall be easy and the relevant procedures for obtaining access to data shall be made publicly available. 3. The rules on access to data and data storage for the purpose of this Directive shall comply with the relevant Union law. The processing of personal data within the framework of this Directive shall be carried out in accordance with Regulation (EU) 2016/679. 4. Member States or, where a Member State has so provided, the designated competent authorities, shall authorise and certify or, where applicable, supervise the parties responsible for the data management, in order to ensure that they comply with the requirements of this Directive. Without prejudice to the tasks of the data protection officers under Regulation (EU) 2016/679, Member States may decide to require that parties responsible for the data management appoint compliance officers who are to be responsible for monitoring the implementation of measures taken by those parties to ensure non-discriminatory access to data and compliance with the requirements of this Directive. Member States may appoint compliance officers or bodies referred to in point (d) of Article 35(2) of this Directive to fulfil the obligations under this paragraph. 5. No additional costs shall be charged to final customers for access to their data or for a request to make their data available. Member States shall be responsible for setting the relevant charges for access to data by eligible parties. Member States or, where a Member State has so provided, the designated competent authorities shall ensure that any charges imposed by regulated entities that provide data services are reasonable and duly justified. Article 24 Interoperability requirements and procedures for access to data 1. In order to promote competition in the retail market and to avoid excessive administrative costs for the eligible parties, Member States shall facilitate the full interoperability of energy services within the Union. 2. The Commission shall adopt, by means of implementing acts, interoperability requirements and non-discriminatory and transparent procedures for access to data referred to in Article 23(1). Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). 3. Member States shall ensure that electricity undertakings apply the interoperability requirements and procedures for access to data referred to in paragraph 2. Those requirements and procedures shall be based on existing national practices. Article 25 Single points of contact Member States shall ensure the provision of single points of contact, to provide customers with all necessary information concerning their rights, the applicable law and dispute settlement mechanisms available to them in the event of a dispute. Such single points of contact may be part of general consumer information points. Article 26 Right to out-of-court dispute settlement 1. Member States shall ensure that final customers have access to simple, fair, transparent, independent, effective and efficient out-of-court mechanisms for the settlement of disputes concerning rights and obligations established under this Directive, through an independent mechanism such as an energy ombudsman or a consumer body, or through a regulatory authority. Where the final customer is a consumer within the meaning of Directive 2013/11/EU of the European Parliament and of the Council (23), such out-of-court dispute settlement mechanisms shall comply with the quality requirements of Directive 2013/11/EU and shall provide, where warranted, for systems of reimbursement and compensation. 2. Where necessary, Member States shall ensure that alternative dispute resolution entities cooperate to provide simple, fair, transparent, independent, effective and efficient out-of-court dispute settlement mechanisms for any dispute that arises from products or services that are tied to, or bundled with, any product or service falling under the scope of this Directive. 3. The participation of electricity undertakings in out-of-court dispute settlement mechanisms for household customers shall be mandatory unless the Member State demonstrates to the Commission that other mechanisms are equally effective. Article 27 Universal service 1. Member States shall ensure that all household customers, and, where Member States deem it to be appropriate, small enterprises, enjoy universal service, namely the right to be supplied with electricity of a specified quality within their territory at competitive, easily and clearly comparable, transparent and non-discriminatory prices. To ensure the provision of universal service, Member States may appoint a supplier of last resort. Member States shall impose on distribution system operators an obligation to connect customers to their network under terms, conditions and tariffs set in accordance with the procedure laid down in Article 59(7). This Directive does not prevent Member States from strengthening the market position of the household customers and small and medium-sized non-household customers by promoting the possibilities for the voluntary aggregation of representation for that class of customers. 2. Paragraph 1 shall be implemented in a transparent and non-discriminatory way, and shall not impede the free choice of supplier provided for in Article 4. Article 28 Vulnerable customers 1. Member States shall take appropriate measures to protect customers and shall ensure, in particular, that there are adequate safeguards to protect vulnerable customers. In this context, each Member State shall define the concept of vulnerable customers which may refer to energy poverty and, inter alia, to the prohibition of disconnection of electricity to such customers in critical times. The concept of vulnerable customers may include income levels, the share of energy expenditure of disposable income, the energy efficiency of homes, critical dependence on electrical equipment for health reasons, age or other criteria. Member States shall ensure that rights and obligations linked to vulnerable customers are applied. In particular, they shall take measures to protect customers in remote areas. They shall ensure high levels of consumer protection, particularly with respect to transparency regarding contractual terms and conditions, general information and dispute settlement mechanisms. 2. Member States shall take appropriate measures, such as providing benefits by means of their social security systems to ensure the necessary supply to vulnerable customers, or providing for support for energy efficiency improvements, to address energy poverty where identified pursuant to point (d) of Article 3(3) of Regulation (EU) 2018/1999, including in the broader context of poverty. Such measures shall not impede the effective opening of the market set out in Article 4 or market functioning and shall be notified to the Commission, where relevant, in accordance with Article 9(4). Such notifications may also include measures taken within the general social security system. Article 29 Energy poverty When assessing the number of households in energy poverty pursuant to point (d) of Article 3(3) of Regulation (EU) 2018/1999, Member States shall establish and publish a set of criteria, which may include low income, high expenditure of disposable income on energy and poor energy efficiency. The Commission shall provide guidance on the definition of \u2018significant number of households in energy poverty\u2019 in this context and in the context of Article 5(5), starting from the premise that any proportion of households in energy poverty can be considered to be significant. CHAPTER IV DISTRIBUTION SYSTEM OPERATION Article 30 Designation of distribution system operators Member States shall designate or shall require undertakings that own or are responsible for distribution systems to designate one or more distribution system operators for a period of time to be determined by the Member States, having regard to considerations of efficiency and economic balance. Article 31 Tasks of distribution system operators 1. The distribution system operator shall be responsible for ensuring the long-term ability of the system to meet reasonable demands for the distribution of electricity, for operating, maintaining and developing under economic conditions a secure, reliable and efficient electricity distribution system in its area with due regard for the environment and energy efficiency. 2. In any event, the distribution system operator shall not discriminate between system users or classes of system users, particularly in favour of its related undertakings. 3. The distribution system operator shall provide system users with the information they need for efficient access to, including use of, the system. 4. A Member State may require the distribution system operator, when dispatching generating installations, to give priority to generating installations using renewable sources or using high-efficiency cogeneration, in accordance with Article 12 of Regulation (EU) 2019/943. 5. Each distribution system operator shall act as a neutral market facilitator in procuring the energy it uses to cover energy losses in its system in accordance with transparent, non-discriminatory and market-based procedures, where it has such a function. 6. Where a distribution system operator is responsible for the procurement of products and services necessary for the efficient, reliable and secure operation of the distribution system, rules adopted by the distribution system operator for that purpose shall be objective, transparent and non-discriminatory, and shall be developed in coordination with transmission system operators and other relevant market participants. The terms and conditions, including rules and tariffs, where applicable, for the provision of such products and services to distribution system operators shall be established in accordance with Article 59(7) in a non-discriminatory and cost-reflective way and shall be published. 7. In performing the tasks referred to in paragraph 6, the distribution system operator shall procure the non-frequency ancillary services needed for its system in accordance with transparent, non-discriminatory and market-based procedures, unless the regulatory authority has assessed that the market-based provision of non-frequency ancillary services is economically not efficient and has granted a derogation. The obligation to procure non-frequency ancillary services does not apply to fully integrated network components. 8. The procurement of the products and services referred to in paragraph 6 shall ensure the effective participation of all qualified market participants, including market participants offering energy from renewable sources, market participants engaged in demand response, operators of energy storage facilities and market participants engaged in aggregation, in particular by requiring regulatory authorities and distribution system operators in close cooperation with all market participants, as well as transmission system operators, to establish the technical requirements for participation in those markets on the basis of the technical characteristics of those markets and the capabilities of all market participants. 9. Distribution system operators shall cooperate with transmission system operators for the effective participation of market participants connected to their grid in retail, wholesale and balancing markets. Delivery of balancing services stemming from resources located in the distribution system shall be agreed with the relevant transmission system operator in accordance with Article 57 of Regulation (EU) 2019/943 and Article 182 of Commission Regulation (EU) 2017/1485 (24). 10. Member States or their designated competent authorities may allow distribution system operators to perform activities other than those provided for in this Directive and in Regulation (EU) 2019/943, where such activities are necessary for the distribution system operators to fulfil their obligations under this Directive or Regulation (EU) 2019/943, provided that the regulatory authority has assessed the necessity of such a derogation. This paragraph shall be without prejudice to the right of the distribution system operators to own, develop, manage or operate networks other than electricity networks where the Member State or the designated competent authority has granted such a right. Article 32 Incentives for the use of flexibility in distribution networks 1. Member States shall provide the necessary regulatory framework to allow and provide incentives to distribution system operators to procure flexibility services, including congestion management in their areas, in order to improve efficiencies in the operation and development of the distribution system. In particular, the regulatory framework shall ensure that distribution system operators are able to procure such services from providers of distributed generation, demand response or energy storage and shall promote the uptake of energy efficiency measures, where such services cost-effectively alleviate the need to upgrade or replace electricity capacity and support the efficient and secure operation of the distribution system. Distribution system operators shall procure such services in accordance with transparent, non-discriminatory and market-based procedures unless the regulatory authorities have established that the procurement of such services is not economically efficient or that such procurement would lead to severe market distortions or to higher congestion. 2. Distribution system operators, subject to approval by the regulatory authority, or the regulatory authority itself, shall, in a transparent and participatory process that includes all relevant system users and transmission system operators, establish the specifications for the flexibility services procured and, where appropriate, standardised market products for such services at least at national level. The specifications shall ensure the effective and non-discriminatory participation of all market participants, including market participants offering energy from renewable sources, market participants engaged in demand response, operators of energy storage facilities and market participants engaged in aggregation. Distribution system operators shall exchange all necessary information and shall coordinate with transmission system operators in order to ensure the optimal utilisation of resources, to ensure the secure and efficient operation of the system and to facilitate market development. Distribution system operators shall be adequately remunerated for the procurement of such services to allow them to recover at least their reasonable corresponding costs, including the necessary information and communication technology expenses and infrastructure costs. 3. The development of a distribution system shall be based on a transparent network development plan that the distribution system operator shall publish at least every two years and shall submit to the regulatory authority. The network development plan shall provide transparency on the medium and long-term flexibility services needed, and shall set out the planned investments for the next five-to-ten years, with particular emphasis on the main distribution infrastructure which is required in order to connect new generation capacity and new loads, including recharging points for electric vehicles. The network development plan shall also include the use of demand response, energy efficiency, energy storage facilities or other resources that the distribution system operator is to use as an alternative to system expansion. 4. The distribution system operator shall consult all relevant system users and the relevant transmission system operators on the network development plan. The distribution system operator shall publish the results of the consultation process along with the network development plan, and submit the results of the consultation and the network development plan to the regulatory authority. The regulatory authority may request amendments to the plan. 5. Member States may decide not to apply the obligation set out in paragraph 3 to integrated electricity undertakings which serve less than 100 000 connected customers or which serve small isolated systems. Article 33 Integration of electromobility into the electricity network 1. Without prejudice to Directive 2014/94/EU of the European Parliament and of the Council (25), Member States shall provide the necessary regulatory framework to facilitate the connection of publicly accessible and private recharging points to the distribution networks. Member States shall ensure that distribution system operators cooperate on a non-discriminatory basis with any undertaking that owns, develops, operates or manages recharging points for electric vehicles, including with regard to connection to the grid. 2. Distribution system operators shall not own, develop, manage or operate recharging points for electric vehicles, except where distribution system operators own private recharging points solely for their own use. 3. By way of derogation from paragraph 2, Member States may allow distribution system operators to own, develop, manage or operate recharging points for electric vehicles, provided that all of the following conditions are fulfilled: (a) other parties, following an open, transparent and non-discriminatory tendering procedure that is subject to review and approval by the regulatory authority, have not been awarded a right to own, develop, manage or operate recharging points for electric vehicles, or could not deliver those services at a reasonable cost and in a timely manner; (b) the regulatory authority has carried out an ex ante review of the conditions of the tendering procedure under point (a) and has granted its approval; (c) the distribution system operator operates the recharging points on the basis of third-party access in accordance with Article 6 and does not discriminate between system users or classes of system users, and in particular in favour of its related undertakings. The regulatory authority may draw up guidelines or procurement clauses to help distribution system operators ensure a fair tendering procedure. 4. Where Member States have implemented the conditions set out in paragraph 3, Member States or their designated competent authorities shall perform, at regular intervals or at least every five years, a public consultation in order to re-assess the potential interest of other parties in owning, developing, operating or managing recharging points for electric vehicles. Where the public consultation indicates that other parties are able to own, develop, operate or manage such points, Member States shall ensure that distribution system operators' activities in this regard are phased-out, subject to the successful completion of the tendering procedure referred to in point (a) of paragraph 3. As part of the conditions of that procedure, regulatory authorities may allow the distribution system operator to recover the residual value of its investment in recharging infrastructure. Article 34 Tasks of distribution system operators in data management Member States shall ensure that all eligible parties have non-discriminatory access to data under clear and equal terms, in accordance with the relevant data protection rules. In Member States where smart metering systems have been deployed in accordance with Article 19 and where distribution system operators are involved in data management, the compliance programmes referred to in point (d) of Article 35(2) shall include specific measures in order to exclude discriminatory access to data from eligible parties as provided for in Article 23. Where distribution system operators are not subject to Article 35(1), (2) or (3), Member States shall take all necessary measures to ensure that vertically integrated undertakings do not have privileged access to data for the conduct of their supply activities. Article 35 Unbundling of distribution system operators 1. Where the distribution system operator is part of a vertically integrated undertaking, it shall be independent at least in terms of its legal form, organisation and decision-making from other activities not relating to distribution. Those rules shall not create an obligation to separate the ownership of assets of the distribution system operator from the vertically integrated undertaking. 2. In addition to the requirements under paragraph 1, where the distribution system operator is part of a vertically integrated undertaking, it shall be independent in terms of its organisation and decision-making from the other activities not related to distribution. In order to achieve this, the following minimum criteria shall apply: (a) the persons responsible for the management of the distribution system operator must not participate in company structures of the integrated electricity undertaking responsible, directly or indirectly, for the day-to-day operation of the generation, transmission or supply of electricity; (b) appropriate measures must be taken to ensure that the professional interests of the persons responsible for the management of the distribution system operator are taken into account in a manner that ensures that they are capable of acting independently; (c) the distribution system operator must have effective decision-making rights, independent from the integrated electricity undertaking, with respect to assets necessary to operate, maintain or develop the network. In order to fulfil those tasks, the distribution system operator shall have at its disposal the necessary resources including human, technical, physical and financial resources. This should not prevent the existence of appropriate coordination mechanisms to ensure that the economic and management supervision rights of the parent company in respect of return on assets, regulated indirectly in accordance with Article 59(7), in a subsidiary are protected. In particular, this shall enable the parent company to approve the annual financial plan, or any equivalent instrument, of the distribution system operator and to set global limits on the levels of indebtedness of its subsidiary. It shall not permit the parent company to give instructions regarding day-to-day operations, nor with respect to individual decisions concerning the construction or upgrading of distribution lines, that do not exceed the terms of the approved financial plan, or any equivalent instrument; and (d) the distribution system operator must establish a compliance programme, which sets out measures taken to ensure that discriminatory conduct is excluded, and ensure that observance of it is adequately monitored. The compliance programme shall set out the specific obligations of employees to meet that objective. An annual report, setting out the measures taken, shall be submitted by the person or body responsible for monitoring the compliance programme, the compliance officer of the distribution system operator, to the regulatory authority referred to in Article 57(1) and shall be published. The compliance officer of the distribution system operator shall be fully independent and shall have access to all the necessary information of the distribution system operator and any affiliated undertaking to fulfil its task. 3. Where the distribution system operator is part of a vertically integrated undertaking, the Member States shall ensure that the activities of the distribution system operator are monitored by regulatory authorities or other competent bodies so that it cannot take advantage of its vertical integration to distort competition. In particular, vertically integrated distribution system operators shall not, in their communication and branding, create confusion with respect to the separate identity of the supply branch of the vertically integrated undertaking. 4. Member States may decide not to apply paragraphs 1, 2 and 3 to integrated electricity undertakings which serve less than 100 000 connected customers, or serving small isolated systems. Article 36 Ownership of energy storage facilities by distribution system operators 1. Distribution system operators shall not own, develop, manage or operate energy storage facilities. 2. By way of derogation from paragraph 1, Member States may allow distribution system operators to own, develop, manage or operate energy storage facilities, where they are fully integrated network components and the regulatory authority has granted its approval, or where all of the following conditions are fulfilled: (a) other parties, following an open, transparent and non-discriminatory tendering procedure that is subject to review and approval by the regulatory authority, have not been awarded a right to own, develop, manage or operate such facilities, or could not deliver those services at a reasonable cost and in a timely manner; (b) such facilities are necessary for the distribution system operators to fulfil their obligations under this Directive for the efficient, reliable and secure operation of the distribution system and the facilities are not used to buy or sell electricity in the electricity markets; and (c) the regulatory authority has assessed the necessity of such a derogation and has carried out an assessment of the tendering procedure, including the conditions of the tendering procedure, and has granted its approval. The regulatory authority may draw up guidelines or procurement clauses to help distribution system operators ensure a fair tendering procedure. 3. The regulatory authorities shall perform, at regular intervals or at least every five years, a public consultation on the existing energy storage facilities in order to assess the potential availability and interest in investing in such facilities. Where the public consultation, as assessed by the regulatory authority, indicates that third parties are able to own, develop, operate or manage such facilities in a cost-effective manner, the regulatory authority shall ensure that the distribution system operators' activities in this regard are phased out within 18 months. As part of the conditions of that procedure, regulatory authorities may allow the distribution system operators to receive reasonable compensation, in particular to recover the residual value of their investment in the energy storage facilities. 4. Paragraph 3 shall not apply to fully integrated network components or for the usual depreciation period of new battery storage facilities with a final investment decision until 4 July 2019, provided that such battery storage facilities are: (a) connected to the grid at the latest two years thereafter; (b) integrated into the distribution system; (c) used only for the reactive instantaneous restoration of network security in the case of network contingencies where such restoration measure starts immediately and ends when regular re-dispatch can solve the issue; and (d) not used to buy or sell electricity in the electricity markets, including balancing. Article 37 Confidentiality obligation of distribution system operators Without prejudice to Article 55 or another legal requirement to disclose information, the distribution system operator shall preserve the confidentiality of commercially sensitive information obtained in the course of carrying out its business, and shall prevent information about its own activities which may be commercially advantageous from being disclosed in a discriminatory manner. Article 38 Closed distribution systems 1. Member States may provide for regulatory authorities or other competent authorities to classify a system which distributes electricity within a geographically confined industrial, commercial or shared services site and does not, without prejudice to paragraph 4, supply household customers, as a closed distribution system if: (a) for specific technical or safety reasons, the operations or the production process of the users of that system are integrated; or (b) that system distributes electricity primarily to the owner or operator of the system or their related undertakings. 2. Closed distribution systems shall be considered to be distribution systems for the purposes of this Directive. Member States may provide for regulatory authorities to exempt the operator of a closed distribution system from: (a) the requirement under Article 31(5) and (7) to procure the energy it uses to cover energy losses and the non-frequency ancillary services in its system in accordance with transparent, non-discriminatory and market-based procedures; (b) the requirement under Article 6(1) that tariffs, or the methodologies underlying their calculation, are approved in accordance with Article 59(1) prior to their entry into force; (c) the requirements under Article 32(1) to procure flexibility services and under Article 32(3) to develop the operator's system on the basis of network development plans; (d) the requirement under Article 33(2) not to own, develop, manage or operate recharging points for electric vehicles; and (e) the requirement under Article 36(1) not to own, develop, manage or operate energy storage facilities. 3. Where an exemption is granted under paragraph 2, the applicable tariffs, or the methodologies underlying their calculation, shall be reviewed and approved in accordance with Article 59(1) upon request by a user of the closed distribution system. 4. Incidental use by a small number of households with employment or similar associations with the owner of the distribution system and located within the area served by a closed distribution system shall not preclude an exemption under paragraph 2 being granted. Article 39 Combined operator Article 35(1) shall not prevent the operation of a combined transmission and distribution system operator, provided that the operator complies with Article 43(1), Articles 44 and 45, or Section 3 of Chapter VI, or that the operator falls under Article 66(3). CHAPTER V GENERAL RULES APPLICABLE TO TRANSMISSION SYSTEM OPERATORS Article 40 Tasks of transmission system operators 1. Each transmission system operator shall be responsible for: (a) ensuring the long-term ability of the system to meet reasonable demands for the transmission of electricity, operating, maintaining and developing under economic conditions secure, reliable and efficient transmission system with due regard to the environment, in close cooperation with neighbouring transmission system operators and distribution system operators; (b) ensuring adequate means to meet its obligations; (c) contributing to security of supply through adequate transmission capacity and system reliability; (d) managing electricity flows on the system, taking into account exchanges with other interconnected systems. To that end, the transmission system operator shall be responsible for ensuring a secure, reliable and efficient electricity system and, in that context, for ensuring the availability of all necessary ancillary services, including those provided by demand response and energy storage facilities, insofar as such availability is independent from any other transmission systems with which its system is interconnected; (e) providing to the operator of other systems with which its system is interconnected sufficient information to ensure the secure and efficient operation, coordinated development and interoperability of the interconnected system; (f) ensuring non-discrimination as between system users or classes of system users, particularly in favour of its related undertakings; (g) providing system users with the information they need for efficient access to the system; (h) collecting congestion rents and payments under the inter-transmission system operator compensation mechanism, in accordance with Article 49 of Regulation (EU) 2019/943, granting and managing third-party access and giving reasoned explanations when it denies such access, which shall be monitored by the regulatory authorities; in carrying out their tasks under this Article transmission system operators shall primarily facilitate market integration; (i) procuring ancillary services to ensure operational security; (j) adopting a framework for cooperation and coordination between the regional coordination centres; (k) participating in the establishment of the European and national resource adequacy assessments pursuant to Chapter IV of Regulation (EU) 2019/943; (l) the digitalisation of transmission systems; (m) data management, including the development of data management systems, cybersecurity and data protection, subject to the applicable rules, and without prejudice to the competence of other authorities. 2. Member States may provide that one or several responsibilities listed in paragraph 1 of this Article be assigned to a transmission system operator other than the one which owns the transmission system to which the responsibilities concerned would otherwise be applicable. The transmission system operator to which the tasks are assigned shall be certified under the ownership unbundling, the independent system operator or the independent transmission system operator model, and fulfil the requirements provided for in Article 43, but shall not be required to own the transmission system it is responsible for. The transmission system operator which owns the transmission system shall fulfil the requirements provided for in Chapter VI and be certified in accordance with Article 43. This shall be without prejudice to the possibility for transmission system operators which are certified under the ownership unbundling, the independent system operator or the independent transmission system operator model to delegate, on their own initiative and under their supervision, certain tasks to other transmission system operators which are certified under the ownership unbundling, the independent system operator or the independent transmission system operator model where that delegation of tasks does not endanger the effective and independent decision-making rights of the delegating transmission system operator. 3. In performing the tasks referred to in paragraph 1, transmission system operators shall take into account the recommendations issued by the regional coordination centres. 4. In performing the task referred to in point (i) of paragraph 1, transmission system operators shall procure balancing services subject to the following: (a) transparent, non-discriminatory and market-based procedures; (b) the participation of all qualified electricity undertakings and market participants, including market participants offering energy from renewable sources, market participants engaged in demand response, operators of energy storage facilities and market participants engaged in aggregation. For the purpose of point (b) of the first subparagraph, regulatory authorities and transmission system operators shall, in close cooperation with all market participants, establish technical requirements for participation in those markets, on the basis of the technical characteristics of those markets. 5. Paragraph 4 shall apply to the provision of non-frequency ancillary services by transmission system operators, unless the regulatory authority has assessed that the market-based provision of non-frequency ancillary services is economically not efficient and has granted a derogation. In particular, the regulatory framework shall ensure that transmission system operators are able to procure such services from providers of demand response or energy storage and shall promote the uptake of energy efficiency measures, where such services cost-effectively alleviate the need to upgrade or replace electricity capacity and support the efficient and secure operation of the transmission system. 6. Transmission system operators, subject to approval by the regulatory authority, or the regulatory authority itself, shall, in a transparent and participatory process that includes all relevant system users and the distribution system operators, establish the specifications for the non-frequency ancillary services procured and, where appropriate, standardised market products for such services at least at national level. The specifications shall ensure the effective and non-discriminatory participation of all market participants, including market participants offering energy from renewable sources, market participants engaged in demand response, operators of energy storage facilities and market participants engaged in aggregation. Transmission system operators shall exchange all necessary information and shall coordinate with distribution system operators in order to ensure the optimal utilisation of resources, to ensure the secure and efficient operation of the system and to facilitate market development. Transmission system operators shall be adequately remunerated for the procurement of such services to allow them to recover at least the reasonable corresponding costs, including the necessary information and communication technology expenses and infrastructure costs. 7. The obligation to procure non-frequency ancillary services referred to in paragraph 5 does not apply to fully integrated network components. 8. Member States or their designated competent authorities may allow transmission system operators to perform activities other than those provided for in this Directive and in Regulation (EU) 2019/943 where such activities are necessary for the transmission system operators to fulfil their obligations under this Directive or Regulation (EU) 2019/943, provided that the regulatory authority has assessed the necessity of such a derogation. This paragraph shall be without prejudice to the right of the transmission system operators to own, develop, manage or operate networks other than electricity networks where the Member State or the designated competent authority has granted such a right. Article 41 Confidentiality and transparency requirements for transmission system operators and transmission system owners 1. Without prejudice to Article 55 or another legal duty to disclose information, each transmission system operator and each transmission system owner shall preserve the confidentiality of commercially sensitive information obtained in the course of carrying out its activities, and shall prevent information about its own activities which may be commercially advantageous from being disclosed in a discriminatory manner. In particular it shall not disclose any commercially sensitive information to the remaining parts of the undertaking, unless such disclosure is necessary for carrying out a business transaction. In order to ensure the full respect of the rules on information unbundling, Member States shall ensure that the transmission system owner and the remaining part of the undertaking do not use joint services, such as joint legal services, apart from purely administrative or IT functions. 2. Transmission system operators shall not, in the context of sales or purchases of electricity by related undertakings, misuse commercially sensitive information obtained from third parties in the context of providing or negotiating access to the system. 3. Information necessary for effective competition and the efficient functioning of the market shall be made public. That obligation shall be without prejudice to preserving the confidentiality of commercially sensitive information. Article 42 Decision-making powers regarding the connection of new generating installations and energy storage facilities to the transmission system 1. The transmission system operator shall establish and publish transparent and efficient procedures for non-discriminatory connection of new generating installations and energy storage facilities to the transmission system. Those procedures shall be subject to approval by the regulatory authorities. 2. The transmission system operator shall not be entitled to refuse the connection of a new generating installation or energy storage facility on the grounds of possible future limitations to available network capacities, such as congestion in distant parts of the transmission system. The transmission system operator shall supply necessary information. The first subparagraph shall be without prejudice to the possibility for transmission system operators to limit the guaranteed connection capacity or to offer connections subject to operational limitations, in order to ensure economic efficiency regarding new generating installations or energy storage facilities, provided that such limitations have been approved by the regulatory authority. The regulatory authority shall ensure that any limitations in guaranteed connection capacity or operational limitations are introduced on the basis of transparent and non-discriminatory procedures and do not create undue barriers to market entry. Where the generating installation or energy storage facility bears the costs related to ensuring unlimited connection, no limitation shall apply. 3. The transmission system operator shall not be entitled to refuse a new connection point, on the ground that it would lead to additional costs resulting from the necessary capacity increase of system elements in the close-up range to the connection point. CHAPTER VI UNBUNDLING OF TRANSMISSION SYSTEM OPERATORS Section 1 Ownership unbundling Article 43 Ownership unbundling of transmission systems and transmission system operators 1. Member States shall ensure that: (a) each undertaking which owns a transmission system acts as a transmission system operator; (b) the same person or persons are not entitled either: (i) directly or indirectly to exercise control over an undertaking performing any of the functions of generation or supply, and directly or indirectly to exercise control or exercise any right over a transmission system operator or over a transmission system; or (ii) directly or indirectly to exercise control over a transmission system operator or over a transmission system, and directly or indirectly to exercise control or exercise any right over an undertaking performing any of the functions of generation or supply; (c) the same person or persons are not entitled to appoint members of the supervisory board, the administrative board or bodies legally representing the undertaking, of a transmission system operator or a transmission system, and directly or indirectly to exercise control or exercise any right over an undertaking performing any of the functions of generation or supply; and (d) the same person is not entitled to be a member of the supervisory board, the administrative board or bodies legally representing the undertaking, of both an undertaking performing any of the functions of generation or supply and a transmission system operator or a transmission system. 2. The rights referred to in points (b) and (c) of paragraph 1 shall include, in particular: (a) the power to exercise voting rights; (b) the power to appoint members of the supervisory board, the administrative board or bodies legally representing the undertaking; or (c) the holding of a majority share. 3. For the purpose of point (b) of paragraph 1, the notion \u2018undertaking performing any of the functions of generation or supply\u2019 shall include \u2018undertaking performing any of the functions of production and supply\u2019 within the meaning of Directive 2009/73/EC, and the terms \u2018transmission system operator\u2019 and \u2018transmission system\u2019 shall include \u2018transmission system operator\u2019 and \u2018transmission system\u2019 within the meaning of that Directive. 4. The obligation set out in point (a) of paragraph 1 shall be deemed to be fulfilled in a situation where two or more undertakings which own transmission systems have created a joint venture which acts as a transmission system operator in two or more Member States for the transmission systems concerned. No other undertaking may be part of the joint venture, unless it has been approved under Article 44 as an independent system operator or as an independent transmission operator for the purposes of Section 3. 5. For the implementation of this Article, where the person referred to in points (b), (c) and (d) of paragraph 1 is the Member State or another public body, two separate public bodies exercising control over a transmission system operator or over a transmission system on the one hand, and over an undertaking performing any of the functions of generation or supply on the other, shall be deemed not to be the same person or persons. 6. Member States shall ensure that neither commercially sensitive information referred to in Article 41 held by a transmission system operator which was part of a vertically integrated undertaking, nor the staff of such a transmission system operator, is transferred to undertakings performing any of the functions of generation and supply. 7. Where on 3 September 2009, the transmission system belongs to a vertically integrated undertaking a Member State may decide not to apply paragraph 1. In such case, the Member State concerned shall either: (a) designate an independent system operator in accordance with Article 44; or (b) comply with Section 3. 8. Where, on 3 September 2009, the transmission system belongs to a vertically integrated undertaking and there are arrangements in place which guarantee more effective independence of the transmission system operator than Section 3, a Member State may decide not to apply paragraph 1. 9. Before an undertaking is approved and designated as a transmission system operator under paragraph 8 of this Article, it shall be certified in accordance with the procedures laid down in Article 52(4), (5), and (6) of this Directive and in Article 51 of Regulation (EU) 2019/943, pursuant to which the Commission shall verify that the arrangements in place clearly guarantee more effective independence of the transmission system operator than Section 3 of this Chapter. 10. Vertically integrated undertakings which own a transmission system shall not in any event be prevented from taking steps to comply with paragraph 1. 11. Undertakings performing any of the functions of generation or supply shall not in any event be able to directly or indirectly take control over or exercise any right over unbundled transmission system operators in Member States which apply paragraph 1. Section 2 Independent system operator Article 44 Independent system operator 1. Where the transmission system belongs to a vertically integrated undertaking on 3 September 2009, Member States may decide not to apply Article 43(1) and designate an independent system operator upon a proposal from the transmission system owner. Such designation shall be subject to approval by the Commission. 2. The Member State may approve and designate an independent system operator provided that: (a) the candidate operator has demonstrated that it complies with the requirements laid down in points (b), (c) and (d) of Article 43(1); (b) the candidate operator has demonstrated that it has at its disposal the required financial, technical, physical and human resources to carry out its tasks under Article 40; (c) the candidate operator has undertaken to comply with a ten-year network development plan monitored by the regulatory authority; (d) the transmission system owner has demonstrated its ability to comply with its obligations under paragraph 5. To that end, it shall provide all the draft contractual arrangements with the candidate operator and any other relevant entity; and (e) the candidate operator has demonstrated its ability to comply with its obligations under Regulation (EU) 2019/943, including the cooperation of transmission system operators at European and regional level. 3. Undertakings which have been certified by the regulatory authority as having complied with the requirements of Article 53 and paragraph 2 of this Article shall be approved and designated as independent system operators by Member States. The certification procedure in either Article 52 of this Directive and Article 51 of Regulation (EU) 2019/943 or in Article 53 of this Directive shall be applicable. 4. Each independent system operator shall be responsible for granting and managing third-party access, including the collection of access charges, congestion charges, and payments under the inter-transmission system operator compensation mechanism in accordance with Article 49 of Regulation (EU) 2019/943, as well as for operating, maintaining and developing the transmission system, and for ensuring the long-term ability of the system to meet reasonable demand through investment planning. When developing the transmission system, the independent system operator shall be responsible for planning (including authorisation procedure), construction and commissioning of the new infrastructure. For this purpose, the independent system operator shall act as a transmission system operator in accordance with this Section. The transmission system owner shall not be responsible for granting and managing third-party access, nor for investment planning. 5. Where an independent system operator has been designated, the transmission system owner shall: (a) provide all the relevant cooperation and support to the independent system operator for the fulfilment of its tasks, including in particular all relevant information; (b) finance the investments decided by the independent system operator and approved by the regulatory authority, or give its agreement to financing by any interested party including the independent system operator. The relevant financing arrangements shall be subject to approval by the regulatory authority. Prior to such approval, the regulatory authority shall consult the transmission system owner together with the other interested parties; (c) provide for the coverage of liability relating to the network assets, excluding the liability relating to the tasks of the independent system operator; and (d) provide guarantees to facilitate financing any network expansions with the exception of those investments where, pursuant to point (b), it has given its agreement to financing by any interested party including the independent system operator. 6. In close cooperation with the regulatory authority, the relevant national competition authority shall be granted all relevant powers to effectively monitor compliance of the transmission system owner with its obligations under paragraph 5. Article 45 Unbundling of transmission system owners 1. A transmission system owner, where an independent system operator has been appointed, which is part of a vertically integrated undertaking shall be independent at least in terms of its legal form, organisation and decision-making from other activities not relating to transmission. 2. In order to ensure the independence of the transmission system owner referred to in paragraph 1, the following minimum criteria shall apply: (a) persons responsible for the management of the transmission system owner shall not participate in company structures of the integrated electricity undertaking responsible, directly or indirectly, for the day-to-day operation of the generation, distribution and supply of electricity; (b) appropriate measures shall be taken to ensure that the professional interests of persons responsible for the management of the transmission system owner are taken into account in a manner that ensures that they are capable of acting independently; and (c) the transmission system owner shall establish a compliance programme, which sets out measures taken to ensure that discriminatory conduct is excluded, and ensure that observance of it is adequately monitored. The compliance programme shall set out the specific obligations of employees to meet those objectives. An annual report, setting out the measures taken, shall be submitted by the person or body responsible for monitoring the compliance programme to the regulatory authority and shall be published. Section 3 Independent transmission operators Article 46 Assets, equipment, staff and identity 1. Transmission system operators shall be equipped with all human, technical, physical and financial resources necessary for fulfilling their obligations under this Directive and carrying out the activity of electricity transmission, in particular: (a) assets that are necessary for the activity of electricity transmission, including the transmission system, shall be owned by the transmission system operator; (b) personnel, necessary for the activity of electricity transmission, including the performance of all corporate tasks, shall be employed by the transmission system operator; (c) leasing of personnel and rendering of services, to and from other parts of the vertically integrated undertaking shall be prohibited. A transmission system operator may, however, render services to the vertically integrated undertaking, provided that: (i) the provision of those services does not discriminate between system users, is available to all system users on the same terms and conditions and does not restrict, distort or prevent competition in generation or supply; and (ii) the terms and conditions of the provision of those services are approved by the regulatory authority; (d) without prejudice to the decisions of the Supervisory Body under Article 49, appropriate financial resources for future investment projects and/or for the replacement of existing assets shall be made available to the transmission system operator in due time by the vertically integrated undertaking after an appropriate request from the transmission system operator. 2. The activity of electricity transmission shall include at least the following tasks in addition to those listed in Article 40: (a) the representation of the transmission system operator and contacts to third parties and the regulatory authorities; (b) the representation of the transmission system operator within the ENTSO for Electricity; (c) granting and managing third-party access on a non-discriminatory basis between system users or classes of system users; (d) the collection of all the transmission system related charges including access charges, energy for losses and ancillary services charges; (e) the operation, maintenance and development of a secure, efficient and economic transmission system; (f) investment planning ensuring the long-term ability of the system to meet reasonable demand and guaranteeing security of supply; (g) the setting up of appropriate joint ventures, including with one or more transmission system operators, power exchanges, and the other relevant actors pursuing the objectives to develop the creation of regional markets or to facilitate the liberalisation process; and (h) all corporate services, including legal services, accountancy and IT services. 3. Transmission system operators shall be organised in a legal form as referred to in Annex I to Directive (EU) 2017/1132 of the European Parliament and of the Council (26). 4. The transmission system operator shall not, in its corporate identity, communication, branding and premises, create confusion with respect to the separate identity of the vertically integrated undertaking or any part thereof. 5. The transmission system operator shall not share IT systems or equipment, physical premises and security access systems with any part of the vertically integrated undertaking nor use the same consultants or external contractors for IT systems or equipment, and security access systems. 6. The accounts of transmission system operators shall be audited by an auditor other than the one auditing the vertically integrated undertaking or any part thereof. Article 47 Independence of the transmission system operator 1. Without prejudice to the decisions of the Supervisory Body under Article 49, the transmission system operator shall have: (a) effective decision-making rights, independent from the vertically integrated undertaking, with respect to assets necessary to operate, maintain or develop the transmission system; and (b) the power to raise money on the capital market in particular through borrowing and capital increase. 2. The transmission system operator shall at all times act so as to ensure it has the resources it needs in order to carry out the activity of transmission properly and efficiently and develop and maintain an efficient, secure and economic transmission system. 3. Subsidiaries of the vertically integrated undertaking performing functions of generation or supply shall not have any direct or indirect shareholding in the transmission system operator. The transmission system operator shall neither have any direct or indirect shareholding in any subsidiary of the vertically integrated undertaking performing functions of generation or supply, nor receive dividends or other financial benefits from that subsidiary. 4. The overall management structure and the corporate statutes of the transmission system operator shall ensure effective independence of the transmission system operator in accordance with this Section. The vertically integrated undertaking shall not determine, directly or indirectly, the competitive behaviour of the transmission system operator in relation to the day-to-day activities of the transmission system operator and management of the network, or in relation to activities necessary for the preparation of the ten-year network development plan developed pursuant to Article 51. 5. In fulfilling their tasks in Article 40 and Article 46(2) of this Directive, and in complying with obligations set out in Articles 16, 18, 19 and 50 of Regulation (EU) 2019/943, transmission system operators shall not discriminate against different persons or entities and shall not restrict, distort or prevent competition in generation or supply. 6. Any commercial and financial relations between the vertically integrated undertaking and the transmission system operator, including loans from the transmission system operator to the vertically integrated undertaking, shall comply with market conditions. The transmission system operator shall keep detailed records of such commercial and financial relations and make them available to the regulatory authority upon request. 7. The transmission system operator shall submit for approval by the regulatory authority all commercial and financial agreements with the vertically integrated undertaking. 8. The transmission system operator shall inform the regulatory authority of the financial resources, referred to in point (d) of Article 46(1), available for future investment projects and/or for the replacement of existing assets. 9. The vertically integrated undertaking shall refrain from any action impeding or prejudicing the transmission system operator from complying with its obligations in this Chapter and shall not require the transmission system operator to seek permission from the vertically integrated undertaking in fulfilling those obligations. 10. An undertaking which has been certified by the regulatory authority as being in accordance with the requirements of this Chapter shall be approved and designated as a transmission system operator by the Member State concerned. The certification procedure in either Article 52 of this Directive and Article 51 of Regulation (EU) 2019/943 or in Article 53 of this Directive shall apply. Article 48 Independence of the staff and the management of the transmission system operator 1. Decisions regarding the appointment and renewal, working conditions including remuneration, and termination of the term of office of the persons responsible for the management and/or members of the administrative bodies of the transmission system operator shall be taken by the Supervisory Body of the transmission system operator appointed in accordance with Article 49. 2. The identity and the conditions governing the term, the duration and the termination of office of the persons nominated by the Supervisory Body for appointment or renewal as persons responsible for the executive management and/or as members of the administrative bodies of the transmission system operator, and the reasons for any proposed decision terminating such term of office, shall be notified to the regulatory authority. Those conditions and the decisions referred to in paragraph 1 shall become binding only if the regulatory authority has raised no objections within three weeks of notification. The regulatory authority may object to the decisions referred to in paragraph 1 where: (a) doubts arise as to the professional independence of a nominated person responsible for the management and/or member of the administrative bodies; or (b) in the case of premature termination of a term of office, doubts exist regarding the justification of such premature termination. 3. No professional position or responsibility, interest or business relationship, directly or indirectly, with the vertically integrated undertaking or any part of it or its controlling shareholders other than the transmission system operator shall be exercised for a period of three years before the appointment of the persons responsible for the management and/or members of the administrative bodies of the transmission system operator who are subject to this paragraph. 4. The persons responsible for the management and/or members of the administrative bodies, and employees of the transmission system operator shall have no other professional position or responsibility, interest or business relationship, directly or indirectly, with another part of the vertically integrated undertaking or with its controlling shareholders. 5. The persons responsible for the management and/or members of the administrative bodies, and employees of the transmission system operator shall hold no interest in or receive any financial benefit, directly or indirectly, from any part of the vertically integrated undertaking other than the transmission system operator. Their remuneration shall not depend on activities or results of the vertically integrated undertaking other than those of the transmission system operator. 6. Effective rights of appeal to the regulatory authority shall be guaranteed for any complaints by the persons responsible for the management and/or members of the administrative bodies of the transmission system operator against premature terminations of their term of office. 7. After termination of their term of office in the transmission system operator, the persons responsible for its management and/or members of its administrative bodies shall have no professional position or responsibility, interest or business relationship with any part of the vertically integrated undertaking other than the transmission system operator, or with its controlling shareholders for a period of not less than four years. 8. Paragraph 3 shall apply to the majority of the persons responsible for the management and/or members of the administrative bodies of the transmission system operator. The persons responsible for the management and/or members of the administrative bodies of the transmission system operator who are not subject to paragraph 3 shall have exercised no management or other relevant activity in the vertically integrated undertaking for a period of at least six months before their appointment. The first subparagraph of this paragraph and paragraphs 4 to 7 shall be applicable to all the persons belonging to the executive management and to those directly reporting to them on matters related to the operation, maintenance or development of the network. Article 49 Supervisory Body 1. The transmission system operator shall have a Supervisory Body which shall be in charge of taking decisions which may have a significant impact on the value of the assets of the shareholders within the transmission system operator, in particular decisions regarding the approval of the annual and longer-term financial plans, the level of indebtedness of the transmission system operator and the amount of dividends distributed to shareholders. The decisions falling under the remit of the Supervisory Body shall exclude those that are related to the day-to-day activities of the transmission system operator and management of the network, and to activities necessary for the preparation of the ten-year network development plan developed pursuant to Article 51. 2. The Supervisory Body shall be composed of members representing the vertically integrated undertaking, members representing third-party shareholders and, where the relevant national law so provides, members representing other interested parties such as employees of the transmission system operator. 3. The first subparagraph of Article 48(2) and Article 48(3) to (7) shall apply to at least half of the members of the Supervisory Body minus one. Point (b) of the second subparagraph of Article 48(2) shall apply to all the members of the Supervisory Body. Article 50 Compliance programme and compliance officer 1. Member States shall ensure that transmission system operators establish and implement a compliance programme which sets out the measures taken in order to ensure that discriminatory conduct is excluded, and ensure that the compliance with that programme is adequately monitored. The compliance programme shall set out the specific obligations of employees to meet those objectives. It shall be subject to approval by the regulatory authority. Without prejudice to the powers of the regulatory authority, compliance with the programme shall be independently monitored by a compliance officer. 2. The compliance officer shall be appointed by the Supervisory Body, subject to approval by the regulatory authority. The regulatory authority may refuse the approval of the compliance officer only for reasons of lack of independence or professional capacity. The compliance officer may be a natural or legal person. Article 48(2) to (8) shall apply to the compliance officer. 3. The compliance officer shall be in charge of: (a) monitoring the implementation of the compliance programme; (b) elaborating an annual report, setting out the measures taken in order to implement the compliance programme and submitting it to the regulatory authority; (c) reporting to the Supervisory Body and issuing recommendations on the compliance programme and its implementation; (d) notifying the regulatory authority on any substantial breaches with regard to the implementation of the compliance programme; and (e) reporting to the regulatory authority on any commercial and financial relations between the vertically integrated undertaking and the transmission system operator. 4. The compliance officer shall submit the proposed decisions on the investment plan or on individual investments in the network to the regulatory authority. This shall occur at the latest when the management and/or the competent administrative body of the transmission system operator submits them to the Supervisory Body. 5. Where the vertically integrated undertaking, in the general assembly or through the vote of the members of the Supervisory Body it has appointed, has prevented the adoption of a decision with the effect of preventing or delaying investments, which under the ten-year network development plan was to be executed in the following three years, the compliance officer shall report this to the regulatory authority, which then shall act in accordance with Article 51. 6. The conditions governing the mandate or the employment conditions of the compliance officer, including the duration of its mandate, shall be subject to approval by the regulatory authority. Those conditions shall ensure the independence of the compliance officer, including by providing all the resources necessary for fulfilling the compliance officer's duties. During his or her mandate, the compliance officer shall have no other professional position, responsibility or interest, directly or indirectly, in or with any part of the vertically integrated undertaking or with its controlling shareholders. 7. The compliance officer shall report regularly, either orally or in writing, to the regulatory authority and shall have the right to report regularly, either orally or in writing, to the Supervisory Body of the transmission system operator. 8. The compliance officer may attend all meetings of the management or administrative bodies of the transmission system operator, and those of the Supervisory Body and the general assembly. The compliance officer shall attend all meetings that address the following matters: (a) conditions for access to the network, as laid down in Regulation (EU) 2019/943, in particular regarding tariffs, third-party access services, capacity allocation and congestion management, transparency, ancillary services and secondary markets; (b) projects undertaken in order to operate, maintain and develop the transmission system, including interconnection and connection investments; (c) energy purchases or sales necessary for the operation of the transmission system. 9. The compliance officer shall monitor the compliance of the transmission system operator with Article 41. 10. The compliance officer shall have access to all relevant data and to the offices of the transmission system operator and to all the information necessary for the fulfilment of his task. 11. The compliance officer shall have access to the offices of the transmission system operator without prior announcement. 12. After prior approval by the regulatory authority, the Supervisory Body may dismiss the compliance officer. It shall dismiss the compliance officer for reasons of lack of independence or professional capacity upon request of the regulatory authority. Article 51 Network development and powers to make investment decisions 1. At least every two years, transmission system operators shall submit to the regulatory authority a ten-year network development plan based on existing and forecast supply and demand after having consulted all the relevant stakeholders. That network development plan shall contain efficient measures in order to guarantee the adequacy of the system and the security of supply. The transmission system operator shall publish the ten-year network development plan on its website. 2. The ten-year network development plan shall in particular: (a) indicate to market participants the main transmission infrastructure that needs to be built or upgraded over the next ten years; (b) contain all the investments already decided and identify new investments which have to be executed in the next three years; and (c) provide for a time frame for all investment projects. 3. When elaborating the ten-year network development plan, the transmission system operator shall fully take into account the potential for the use of demand response, energy storage facilities or other resources as alternatives to system expansion, as well as expected consumption, trade with other countries and investment plans for Union-wide and regional networks. 4. The regulatory authority shall consult all actual or potential system users on the ten-year network development plan in an open and transparent manner. Persons or undertakings claiming to be potential system users may be required to substantiate such claims. The regulatory authority shall publish the result of the consultation process, in particular possible needs for investments. 5. The regulatory authority shall examine whether the ten-year network development plan covers all investment needs identified during the consultation process, and whether it is consistent with the non-binding Union-wide ten-year network development plan (\u2018Union-wide network development plan\u2019) referred to in point (b) of Article 30(1) of Regulation (EU) 2019/943. If any doubt arises as to the consistency with the Union-wide network development plan, the regulatory authority shall consult ACER. The regulatory authority may require the transmission system operator to amend its ten-year network development plan. The competent national authorities shall examine the consistency of the ten-year network development plan with the national energy and climate plan submitted in accordance with Regulation (EU) 2018/1999. 6. The regulatory authority shall monitor and evaluate the implementation of the ten-year network development plan. 7. In circumstances where the transmission system operator, other than for overriding reasons beyond its control, does not execute an investment, which, under the ten-year network development plan, was to be executed in the following three years, Member States shall ensure that the regulatory authority is required to take at least one of the following measures to ensure that the investment in question is made if such investment is still relevant on the basis of the most recent ten-year network development plan: (a) to require the transmission system operator to execute the investments in question; (b) to organise a tender procedure open to any investors for the investment in question; or (c) to oblige the transmission system operator to accept a capital increase to finance the necessary investments and allow independent investors to participate in the capital. 8. Where the regulatory authority has made use of its powers under point (b) of paragraph 7, it may oblige the transmission system operator to agree to one or more of the following: (a) financing by any third party; (b) construction by any third party; (c) building the new assets concerned itself; (d) operating the new asset concerned itself. The transmission system operator shall provide the investors with all information needed to realise the investment, shall connect new assets to the transmission network and shall generally make its best efforts to facilitate the implementation of the investment project. The relevant financial arrangements shall be subject to approval by the regulatory authority. 9. Where the regulatory authority has made use of its powers under paragraph 7, the relevant tariff regulations shall cover the costs of the investments in question. Section 4 Designation and certification of transmission system operators Article 52 Designation and certification of transmission system operators 1. Before an undertaking is approved and designated as transmission system operator, it shall be certified in accordance with the procedures laid down in paragraphs 4, 5 and 6 of this Article and in Article 51 of Regulation (EU) 2019/943. 2. Undertakings which have been certified by the regulatory authority as having complied with the requirements of Article 43 pursuant to the certification procedure below, shall be approved and designated as transmission system operators by Member States. The designation of transmission system operators shall be notified to the Commission and published in the Official Journal of the European Union. 3. Transmission system operators shall notify to the regulatory authority any planned transaction which may require a reassessment of their compliance with the requirements of Article 43. 4. Regulatory authorities shall monitor the continuing compliance of transmission system operators with the requirements of Article 43. They shall open a certification procedure to ensure such compliance: (a) upon notification by the transmission system operator pursuant to paragraph 3; (b) on their own initiative where they have knowledge that a planned change in rights or influence over transmission system owners or transmission system operators may lead to an infringement of Article 43, or where they have reason to believe that such an infringement may have occurred; or (c) upon a reasoned request from the Commission. 5. The regulatory authorities shall adopt a decision on the certification of a transmission system operator within four months of the date of the notification by the transmission system operator or from the date of the Commission request. After expiry of that period, the certification shall be deemed to be granted. The explicit or tacit decision of the regulatory authority shall become effective only after conclusion of the procedure set out in paragraph 6. 6. The explicit or tacit decision on the certification of a transmission system operator shall be notified without delay to the Commission by the regulatory authority, together with all the relevant information with respect to that decision. The Commission shall act in accordance with the procedure laid down in Article 51 of Regulation (EU) 2019/943. 7. The regulatory authorities and the Commission may request from transmission system operators and undertakings performing any of the functions of generation or supply any information relevant for the fulfilment of their tasks under this Article. 8. Regulatory authorities and the Commission shall preserve the confidentiality of commercially sensitive information. Article 53 Certification in relation to third countries 1. Where certification is requested by a transmission system owner or a transmission system operator which is controlled by a person or persons from a third country or third countries, the regulatory authority shall notify the Commission. The regulatory authority shall also notify to the Commission without delay any circumstances that would result in a person or persons from a third country or third countries acquiring control of a transmission system or a transmission system operator. 2. The transmission system operator shall notify to the regulatory authority any circumstances that would result in a person or persons from a third country or third countries acquiring control of the transmission system or the transmission system operator. 3. The regulatory authority shall adopt a draft decision on the certification of a transmission system operator within four months of the date of notification by the transmission system operator. It shall refuse the certification if it has not been demonstrated: (a) that the entity concerned complies with the requirements of Article 43; and (b) to the regulatory authority or to another competent national authority designated by the Member State that granting certification will not put at risk the security of energy supply of the Member State and the Union. In considering that question the regulatory authority or other competent national authority shall take into account: (i) the rights and obligations of the Union with respect to that third country arising under international law, including any agreement concluded with one or more third countries to which the Union is a party and which addresses the issues of security of energy supply; (ii) the rights and obligations of the Member State with respect to that third country arising under agreements concluded with it, insofar as they comply with Union law; and (iii) other specific facts and circumstances of the case and the third country concerned. 4. The regulatory authority shall notify the decision to the Commission without delay, together with all the relevant information with respect to that decision. 5. Member States shall provide for the regulatory authority or the designated competent authority referred to in point (b) of paragraph 3, before the regulatory authority adopts a decision on the certification, to request an opinion from the Commission on whether: (a) the entity concerned complies with the requirements of Article 43; and (b) granting certification will not put at risk the security of energy supply to the Union. 6. The Commission shall examine the request referred to in paragraph 5 as soon as it is received. Within two months of receiving the request, it shall deliver its opinion to the regulatory authority or, if the request was made by the designated competent authority, to that authority. In preparing the opinion, the Commission may request the views of ACER, the Member State concerned, and interested parties. In the event that the Commission makes such a request, the two-month period shall be extended by two months. In the absence of an opinion by the Commission within the period referred to in the first and second subparagraphs, the Commission shall be deemed not to raise objections to the decision of the regulatory authority. 7. When assessing whether the control by a person or persons from a third country or third countries will put at risk the security of energy supply to the Union, the Commission shall take into account: (a) the specific facts of the case and the third country or third countries concerned; and (b) the rights and obligations of the Union with respect to that third country or third countries arising under international law, including an agreement concluded with one or more third countries to which the Union is a party and which addresses the issues of security of supply. 8. The regulatory authority shall, within two months of the expiry of the period referred to in paragraph 6, adopt its final decision on the certification. In adopting its final decision the regulatory authority shall take utmost account of the Commission's opinion. In any event Member States shall have the right to refuse certification where granting certification puts at risk the Member State's security of energy supply or the security of energy supply of another Member State. Where the Member State has designated another competent national authority to make the assessment referred to in point (b) of paragraph 3, it may require the regulatory authority to adopt its final decision in accordance with the assessment of that competent national authority. The regulatory authority's final decision and the Commission's opinion shall be published together. Where the final decision diverges from the Commission's opinion, the Member State concerned shall provide and publish, together with that decision, the reasoning underlying such decision. 9. Nothing in this Article shall affect the right of Member States to exercise, in accordance with Union law, national legal controls to protect legitimate public security interests. 10. This Article, with exception of point (a) of paragraph 3 thereof, shall also apply to Member States which are subject to a derogation under Article 66. Article 54 Ownership of energy storage facilities by transmission system operators 1. Transmission system operators shall not own, develop, manage or operate energy storage facilities. 2. By way of derogation from paragraph 1, Member States may allow transmission system operators to own, develop, manage or operate energy storage facilities, where they are fully integrated network components and the regulatory authority has granted its approval, or where all of the following conditions are fulfilled: (a) other parties, following an open, transparent and non-discriminatory tendering procedure that is subject to review and approval by the regulatory authority, have not been awarded a right to own, develop, manage or operate such facilities, or could not deliver those services at a reasonable cost and in a timely manner; (b) such facilities or non-frequency ancillary services are necessary for the transmission system operators to fulfil their obligations under this Directive for the efficient, reliable and secure operation of the transmission system and they are not used to buy or sell electricity in the electricity markets; and (c) the regulatory authority has assessed the necessity of such a derogation, has carried out an ex ante review of the applicability of a tendering procedure, including the conditions of the tendering procedure, and has granted its approval. The regulatory authority may draw up guidelines or procurement clauses to help transmission system operators ensure a fair tendering procedure. 3. The decision to grant a derogation shall be notified to the Commission and ACER together with relevant information about the request and the reasons for granting the derogation. 4. The regulatory authorities shall perform, at regular intervals or at least every five years, a public consultation on the existing energy storage facilities in order to assess the potential availability and interest of other parties in investing in such facilities. Where the public consultation, as assessed by the regulatory authority, indicates that other parties are able to own, develop, operate or manage such facilities in a cost-effective manner, the regulatory authority shall ensure that transmission system operators' activities in this regard are phased-out within 18 months. As part of the conditions of that procedure, regulatory authorities may allow the transmission system operators to receive reasonable compensation, in particular to recover the residual value of their investment in the energy storage facilities. 5. Paragraph 4 shall not apply to fully integrated network components or for the usual depreciation period of new battery storage facilities with a final investment decision until 2024, provided that such battery storage facilities are: (a) connected to the grid at the latest two years thereafter; (b) integrated into the transmission system; (c) used only for the reactive instantaneous restoration of network security in the case of network contingencies where such restoration measure starts immediately and ends when regular re-dispatch can solve the issue; and (d) not used to buy or sell electricity in the electricity markets, including balancing. Section 5 Unbundling and transparency of accounts Article 55 Right of access to accounts 1. Member States or any competent authority that they designate, including the regulatory authorities referred to in Article 57, shall, insofar as necessary to carry out their functions, have right of access to the accounts of electricity undertakings as set out in Article 56. 2. Member States and any designated competent authority, including the regulatory authorities, shall preserve the confidentiality of commercially sensitive information. Member States may provide for the disclosure of such information where such disclosure is necessary in order for the competent authorities to carry out their functions. Article 56 Unbundling of accounts 1. Member States shall take the necessary steps to ensure that the accounts of electricity undertakings are kept in accordance with paragraphs 2 and 3. 2. Electricity undertakings, whatever their system of ownership or legal form, shall draw up, submit to audit and publish their annual accounts in accordance with the rules of national law concerning the annual accounts of limited liability companies adopted pursuant to Directive 2013/34/EU. Undertakings which are not legally obliged to publish their annual accounts shall keep a copy of these at the disposal of the public in their head office. 3. Electricity undertakings shall, in their internal accounting, keep separate accounts for each of their transmission and distribution activities as they would be required to do if the activities in question were carried out by separate undertakings, with a view to avoiding discrimination, cross-subsidisation and distortion of competition. They shall also keep accounts, which may be consolidated, for other electricity activities not relating to transmission or distribution. Revenue from ownership of the transmission or distribution system shall be specified in the accounts. Where appropriate, they shall keep consolidated accounts for other, non-electricity activities. The internal accounts shall include a balance sheet and a profit and loss account for each activity. 4. The audit referred to in paragraph 2 shall, in particular, verify that the obligation to avoid discrimination and cross-subsidisation referred to in paragraph 3 is respected. CHAPTER VII REGULATORY AUTHORITIES Article 57 Designation and independence of regulatory authorities 1. Each Member State shall designate a single regulatory authority at national level. 2. Paragraph 1 shall be without prejudice to the designation of other regulatory authorities at regional level within Member States, provided that there is one senior representative for representation and contact purposes at Union level within ACER's Board of Regulators in accordance with Article 21(1) of Regulation (EU) 2019/942. 3. By way of derogation from paragraph 1, a Member State may designate regulatory authorities for small systems in a geographically separate region whose consumption, in 2008, accounted for less than 3 % of the total consumption of the Member State of which it is part. That derogation shall be without prejudice to the appointment of one senior representative for representation and contact purposes at Union level within ACER's Board of Regulators in accordance with Article 21(1) of Regulation (EU) 2019/942. 4. Member States shall guarantee the independence of the regulatory authority and shall ensure that it exercises its powers impartially and transparently. For that purpose, Member States shall ensure that, when carrying out the regulatory tasks conferred upon it by this Directive and related legislation, the regulatory authority: (a) is legally distinct and functionally independent from other public or private entities; (b) ensures that its staff and the persons responsible for its management: (i) act independently from any market interest; and (ii) do not seek or take direct instructions from any government or other public or private entity when carrying out the regulatory tasks. That requirement is without prejudice to close cooperation, as appropriate, with other relevant national authorities or to general policy guidelines issued by the government not related to the regulatory powers and duties under Article 59. 5. In order to protect the independence of the regulatory authority, Member States shall in particular ensure that: (a) the regulatory authority can take autonomous decisions, independently from any political body; (b) the regulatory authority has all the necessary human and financial resources it needs to carry out its duties and exercise its powers in an effective and efficient manner; (c) the regulatory authority has a separate annual budget allocation and autonomy in the implementation of the allocated budget; (d) the members of the board of the regulatory authority or, in the absence of a board, the regulatory authority's top management are appointed for a fixed term of five up to seven years, renewable once; (e) the members of the board of the regulatory authority or, in the absence of a board, the regulatory authority's top management are appointed based on objective, transparent and published criteria, in an independent and impartial procedure, which ensures that the candidates have the necessary skills and experience for the relevant position in the regulatory authority; (f) conflict of interest provisions are in place and confidentiality obligations extend beyond the end of the mandate of the members of the board of the regulatory authority or, in the absence of a board, the end of the mandate of the regulatory authority's top management; (g) the members of the board of the regulatory authority or, in the absence of a board, the regulatory authority's top management can be dismissed only based on transparent criteria in place. In regard to point (d) of the first subparagraph, Member States shall ensure an appropriate rotation scheme for the board or the top management. The members of the board or, in the absence of a board, members of the top management may be relieved from office during their term only if they no longer fulfil the conditions set out in this Article or have been guilty of misconduct under national law. 6. Member States may provide for the ex post control of the regulatory authorities' annual accounts by an independent auditor. 7. By 5 July 2022 and every four years thereafter, the Commission shall submit a report to the European Parliament and the Council on the compliance of national authorities with the principle of independence set out in this Article. Article 58 General objectives of the regulatory authority In carrying out the regulatory tasks specified in this Directive, the regulatory authority shall take all reasonable measures in pursuit of the following objectives within the framework of its duties and powers as laid down in Article 59, in close consultation with other relevant national authorities, including competition authorities, as well as authorities, including regulatory authorities, from neighbouring Member States and neighbouring third countries, as appropriate, and without prejudice to their competence: (a) promoting, in close cooperation with regulatory authorities of other Member States, the Commission and ACER, a competitive, flexible, secure and environmentally sustainable internal market for electricity within the Union, and effective market opening for all customers and suppliers in the Union, and ensuring appropriate conditions for the effective and reliable operation of electricity networks, taking into account long-term objectives; (b) developing competitive and properly functioning regional cross-border markets within the Union with a view to achieving the objectives referred to in point (a); (c) eliminating restrictions on trade in electricity between Member States, including developing appropriate cross-border transmission capacities to meet demand and enhancing the integration of national markets which may facilitate electricity flows across the Union; (d) helping to achieve, in the most cost-effective way, the development of secure, reliable and efficient non-discriminatory systems that are consumer-oriented, and promoting system adequacy and, in accordance with general energy policy objectives, energy efficiency, as well as the integration of large and small-scale production of electricity from renewable sources and distributed generation in both transmission and distribution networks, and facilitating their operation in relation to other energy networks of gas or heat; (e) facilitating access to the network for new generation capacity and energy storage facilities, in particular removing barriers that could prevent access for new market entrants and of electricity from renewable sources; (f) ensuring that system operators and system users are granted appropriate incentives, in both the short and the long term, to increase efficiencies, especially energy efficiency, in system performance and to foster market integration; (g) ensuring that customers benefit through the efficient functioning of their national market, promoting effective competition and helping to ensure a high level of consumer protection, in close cooperation with relevant consumer protection authorities; (h) helping to achieve high standards of universal service and of public service in electricity supply, contributing to the protection of vulnerable customers and contributing to the compatibility of necessary data exchange processes for customer switching. Article 59 Duties and powers of the regulatory authorities 1. The regulatory authority shall have the following duties: (a) fixing or approving, in accordance with transparent criteria, transmission or distribution tariffs or their methodologies, or both; (b) ensuring the compliance of transmission system operators and distribution system operators and, where relevant, system owners, as well as the compliance of any electricity undertakings and other market participants, with their obligations under this Directive, Regulation (EU) 2019/943, the network codes and the guidelines adopted pursuant to Articles 59, 60 and 61 of Regulation (EU) 2019/943, and other relevant Union law, including as regards cross-border issues, as well as with ACER's decisions; (c) in close coordination with the other regulatory authorities, ensuring the compliance of the ENTSO for Electricity and the EU DSO entity with their obligations under this Directive, Regulation (EU) 2019/943, the network codes and guidelines adopted pursuant to Articles 59, 60 and 61 of Regulation (EU) 2019/943, and other relevant Union law, including as regards cross-border issues, as well as with ACER's decisions, and jointly identifying non-compliance of the ENTSO for Electricity and the EU DSO entity with their respective obligations; where the regulatory authorities have not been able to reach an agreement within a period of four months after the start of consultations for the purpose of jointly identifying non-compliance, the matter shall be referred to the ACER for a decision, pursuant to Article 6(10) of Regulation (EU) 2019/942; (d) approving products and procurement process for non-frequency ancillary services; (e) implementing the network codes and guidelines adopted pursuant to Articles 59, 60 and 61 of Regulation (EU) 2019/943 through national measures or, where so required, coordinated regional or Union-wide measures; (f) cooperating in regard to cross-border issues with the regulatory authority or authorities of the Member States concerned and with ACER, in particular through participation in the work of ACER's Board of Regulators pursuant to Article 21 of Regulation (EU) 2019/942; (g) complying with, and implementing, any relevant legally binding decisions of the Commission and of ACER; (h) ensuring that transmission system operators make available interconnector capacities to the utmost extent pursuant to Article 16 of Regulation (EU) 2019/943; (i) reporting annually on its activity and the fulfilment of its duties to the relevant authorities of the Member States, the Commission and ACER, including on the steps taken and the results obtained as regards each of the tasks listed in this Article; (j) ensuring that there is no cross-subsidisation between transmission, distribution and supply activities or other electricity or non-electricity activities; (k) monitoring investment plans of the transmission system operators and providing in its annual report an assessment of the investment plans of the transmission system operators as regards their consistency with the Union-wide network development plan; such assessment may include recommendations to amend those investment plans; (l) monitoring and assessing the performance of transmission system operators and distribution system operators in relation to the development of a smart grid that promotes energy efficiency and the integration of energy from renewable sources, based on a limited set of indicators, and publish a national report every two years, including recommendations; (m) setting or approving standards and requirements for quality of service and quality of supply or contributing thereto together with other competent authorities and monitoring compliance with and reviewing the past performance of network security and reliability rules; (n) monitoring the level of transparency, including of wholesale prices, and ensuring compliance of electricity undertakings with transparency obligations; (o) monitoring the level and effectiveness of market opening and competition at wholesale and retail levels, including on electricity exchanges, prices for household customers including prepayment systems, the impact of dynamic electricity price contracts and of the use of smart metering systems, switching rates, disconnection rates, charges for maintenance services, the execution of maintenance services, the relationship between household and wholesale prices, the evolution of grid tariffs and levies, and complaints by household customers, as well as any distortion or restriction of competition, including by providing any relevant information, and bringing any relevant cases to the relevant competition authorities; (p) monitoring the occurrence of restrictive contractual practices, including exclusivity clauses which may prevent customers from contracting simultaneously with more than one supplier or restrict their choice to do so, and, where appropriate, informing the national competition authorities of such practices; (q) monitoring the time taken by transmission system operators and distribution system operators to make connections and repairs; (r) helping to ensure, together with other relevant authorities, that the consumer protection measures are effective and enforced; (s) publishing recommendations, at least annually, in relation to compliance of supply prices with Article 5, and providing those recommendations to the competition authorities, where appropriate; (t) ensuring non-discriminatory access to customer consumption data, the provision, for optional use, of an easily understandable harmonised format at national level for consumption data, and prompt access for all customers to such data pursuant to Articles 23 and 24; (u) monitoring the implementation of rules relating to the roles and responsibilities of transmission system operators, distribution system operators, suppliers, customers and other market participants pursuant to Regulation (EU) 2019/943; (v) monitoring investment in generation and storage capacities in relation to security of supply; (w) monitoring technical cooperation between Union and third-country transmission system operators; (x) contributing to the compatibility of data exchange processes for the most important market processes at regional level; (y) monitoring the availability of comparison tools that meet the requirements set out in Article 14; (z) monitoring the removal of unjustified obstacles to and restrictions on the development of consumption of self-generated electricity and citizen energy communities. 2. Where a Member State has so provided, the monitoring duties set out in paragraph 1 may be carried out by other authorities than the regulatory authority. In such a case, the information resulting from such monitoring shall be made available to the regulatory authority as soon as possible. While preserving their independence, without prejudice to their own specific competence and consistent with the principles of better regulation, the regulatory authority shall, as appropriate, consult transmission system operators and, as appropriate, closely cooperate with other relevant national authorities when carrying out the duties set out in paragraph 1. Any approvals given by a regulatory authority or ACER under this Directive are without prejudice to any duly justified future use of its powers by the regulatory authority under this Article or to any penalties imposed by other relevant authorities or the Commission. 3. Member States shall ensure that regulatory authorities are granted the powers enabling them to carry out the duties referred to in this Article in an efficient and expeditious manner. For this purpose, the regulatory authority shall have at least the following powers: (a) to issue binding decisions on electricity undertakings; (b) to carry out investigations into the functioning of the electricity markets, and to decide upon and impose any necessary and proportionate measures to promote effective competition and ensure the proper functioning of the market. Where appropriate, the regulatory authority shall also have the power to cooperate with the national competition authority and the financial market regulators or the Commission in conducting an investigation relating to competition law; (c) to require any information from electricity undertakings relevant for the fulfilment of its tasks, including the justification for any refusal to grant third-party access, and any information on measures necessary to reinforce the network; (d) to impose effective, proportionate and dissuasive penalties on electricity undertakings not complying with their obligations under this Directive, Regulation (EU) 2019/943 or any relevant legally binding decisions of the regulatory authority or of ACER, or to propose that a competent court impose such penalties, including the power to impose or propose the imposition of penalties of up to 10 % of the annual turnover of the transmission system operator on the transmission system operator or of up to 10 % of the annual turnover of the vertically integrated undertaking on the vertically integrated undertaking, as the case may be, for non-compliance with their respective obligations pursuant to this Directive; and (e) appropriate rights of investigation and relevant powers of instruction for dispute settlement under Article 60(2) and (3). 4. The regulatory authority located in the Member State in which the ENTSO for Electricity or the EU DSO entity has its seat shall have the power to impose effective, proportionate and dissuasive penalties on those entities where they do not comply with their obligations under this Directive, Regulation (EU) 2019/943 or any relevant legally binding decisions of the regulatory authority or of ACER, or to propose that a competent court impose such penalties. 5. In addition to the duties conferred upon it under paragraphs 1 and 3 of this Article, when an independent system operator has been designated under Article 44, the regulatory authority shall: (a) monitor the transmission system owner's and the independent system operator's compliance with their obligations under this Article, and issue penalties for non-compliance in accordance with point (d) of paragraph 3; (b) monitor the relations and communications between the independent system operator and the transmission system owner so as to ensure compliance of the independent system operator with its obligations, and in particular approve contracts and act as a dispute settlement authority between the independent system operator and the transmission system owner with respect to any complaint submitted by either party pursuant to Article 60(2); (c) without prejudice to the procedure under point (c) of Article 44(2), for the first ten-year network development plan, approve the investments planning and the multi-annual network development plan submitted at least every two years by the independent system operator; (d) ensure that network access tariffs collected by the independent system operator include remuneration for the network owner or network owners, which provides for adequate remuneration of the network assets and of any new investments made therein, provided they are economically and efficiently incurred; (e) have the powers to carry out inspections, including unannounced inspections, at the premises of transmission system owner and independent system operator; and (f) monitor the use of congestion charges collected by the independent system operator in accordance with Article 19(2) of Regulation (EU) 2019/943. 6. In addition to the duties and powers conferred on it under paragraphs 1 and 3 of this Article, when a transmission system operator has been designated in accordance with Section 3 of Chapter VI, the regulatory authority shall be granted at least the following duties and powers: (a) to impose penalties in accordance with point (d) of paragraph 3 for discriminatory behaviour in favour of the vertically integrated undertaking; (b) to monitor communications between the transmission system operator and the vertically integrated undertaking so as to ensure compliance of the transmission system operator with its obligations; (c) to act as dispute settlement authority between the vertically integrated undertaking and the transmission system operator with respect to any complaint submitted pursuant to Article 60(2); (d) to monitor commercial and financial relations including loans between the vertically integrated undertaking and the transmission system operator; (e) to approve all commercial and financial agreements between the vertically integrated undertaking and the transmission system operator on the condition that they comply with market conditions; (f) to request a justification from the vertically integrated undertaking when notified by the compliance officer in accordance with Article 50(4), such justification including, in particular, evidence demonstrating that no discriminatory behaviour to the advantage of the vertically integrated undertaking has occurred; (g) to carry out inspections, including unannounced ones, on the premises of the vertically integrated undertaking and the transmission system operator; and (h) to assign all or specific tasks of the transmission system operator to an independent system operator appointed in accordance with Article 44 in the case of a persistent breach by the transmission system operator of its obligations under this Directive, in particular in the case of repeated discriminatory behaviour to the benefit of the vertically integrated undertaking. 7. The regulatory authorities, except where ACER is competent to fix and approve the terms and conditions or methodologies for the implementation of network codes and guidelines under Chapter VII of Regulation (EU) 2019/943 pursuant to Article 5(2) of Regulation (EU) 2019/942 because of their coordinated nature, shall be responsible for fixing or approving sufficiently in advance of their entry into force at least the national methodologies used to calculate or establish the terms and conditions for: (a) connection and access to national networks, including transmission and distribution tariffs or their methodologies, those tariffs or methodologies shall allow the necessary investments in the networks to be carried out in a manner allowing those investments to ensure the viability of the networks; (b) the provision of ancillary services which shall be performed in the most economic manner possible and provide appropriate incentives for network users to balance their input and off-takes, such ancillary services shall be provided in a fair and non-discriminatory manner and be based on objective criteria; and (c) access to cross-border infrastructures, including the procedures for the allocation of capacity and congestion management. 8. The methodologies or the terms and conditions referred to in paragraph 7 shall be published. 9. With a view to increasing transparency in the market and providing all interested parties with all necessary information and decisions or proposals for decisions concerning transmission and distribution tariffs as referred in Article 60(3), regulatory authorities shall make publicly available the detailed methodology and underlying costs used for the calculation of the relevant network tariffs, while preserving the confidentiality of commercially sensitive information. 10. The regulatory authorities shall monitor congestion management of national electricity systems including interconnectors, and the implementation of congestion management rules. To that end, transmission system operators or market operators shall submit their congestion management rules, including capacity allocation, to the regulatory authorities. Regulatory authorities may request amendments to those rules. Article 60 Decisions and complaints 1. Regulatory authorities shall have the authority to require transmission system operators and distribution system operators, if necessary, to modify the terms and conditions, including tariffs or methodologies referred to Article 59 of this Directive, to ensure that they are proportionate and applied in a non-discriminatory manner, in accordance with Article 18 of Regulation (EU) 2019/943. In the event of delay in the fixing of transmission and distribution tariffs, regulatory authorities shall have the power to fix or approve provisional transmission and distribution tariffs or methodologies and to decide on the appropriate compensatory measures if the final transmission and distribution tariffs or methodologies deviate from those provisional tariffs or methodologies. 2. Any party having a complaint against a transmission or distribution system operator in relation to that operator's obligations under this Directive may refer the complaint to the regulatory authority which, acting as dispute settlement authority, shall issue a decision within two months of receipt of the complaint. That period may be extended by two months where additional information is sought by the regulatory authority. That extended period may be further extended with the agreement of the complainant. The regulatory authority's decision shall have binding effect unless and until overruled on appeal. 3. Any party who is affected and who has a right to complain concerning a decision on methodologies taken pursuant to Article 59 or, where the regulatory authority has a duty to consult, concerning the proposed tariffs or methodologies, may, within two months, or within a shorter period as provided for by Member States, after publication of the decision or proposal for a decision, submit a complaint for review. Such a complaint shall not have suspensive effect. 4. Member States shall create appropriate and efficient mechanisms for regulation, control and transparency so as to avoid any abuse of a dominant position, in particular to the detriment of consumers, and any predatory behaviour. Those mechanisms shall take account of the provisions of the TFEU, and in particular Article 102 thereof. 5. Member States shall ensure that the appropriate measures are taken, including administrative action or criminal proceedings in conformity with their national law, against the natural or legal persons responsible where confidentiality rules imposed by this Directive have not been respected. 6. Complaints referred to in paragraphs 2 and 3 shall be without prejudice to the exercise of rights of appeal under Union or national law. 7. Decisions taken by regulatory authorities shall be fully reasoned and justified to allow for judicial review. The decisions shall be available to the public while preserving the confidentiality of commercially sensitive information. 8. Member States shall ensure that suitable mechanisms exist at national level under which a party affected by a decision of a regulatory authority has a right of appeal to a body independent of the parties involved and of any government. Article 61 Regional cooperation between regulatory authorities on cross-border issues 1. Regulatory authorities shall closely consult and cooperate with each other, in particular within ACER, and shall provide each other and ACER with any information necessary for the fulfilment of their tasks under this Directive. With respect to the information exchanged, the receiving authority shall ensure the same level of confidentiality as that required of the originating authority. 2. Regulatory authorities shall cooperate at least at a regional level to: (a) foster the creation of operational arrangements in order to enable an optimal management of the network, promote joint electricity exchanges and the allocation of cross-border capacity, and to enable an adequate level of interconnection capacity, including through new interconnection, within the region and between regions to allow for development of effective competition and improvement of security of supply, without discriminating between suppliers in different Member States; (b) coordinate the joint oversight of entities performing functions at regional level; (c) coordinate, in cooperation with other involved authorities, the joint oversight of national, regional and European resource adequacy assessments; (d) coordinate the development of all network codes and guidelines for the relevant transmission system operators and other market actors; and (e) coordinate the development of the rules governing the management of congestion. 3. Regulatory authorities shall have the right to enter into cooperative arrangements with each other to foster regulatory cooperation. 4. The actions referred to in paragraph 2 shall be carried out, as appropriate, in close consultation with other relevant national authorities and without prejudice to their specific competence. 5. The Commission is empowered to adopt delegated acts in accordance with Article 67 in order to supplement this Directive by establishing guidelines on the extent of the duties of regulatory authorities to cooperate with each other and with ACER. Article 62 Duties and powers of regulatory authorities with respect to regional coordination centres 1. The regional regulatory authorities of the system operation region in which a regional coordination centre is established shall, in close coordination with each other: (a) approve the proposal for the establishment of regional coordination centres in accordance with Article 35(1) of Regulation (EU) 2019/943; (b) approve the costs related to the activities of the regional coordination centres, which are to be borne by the transmission system operators and to be taken into account in the calculation of tariffs, provided that they are reasonable and appropriate; (c) approve the cooperative decision-making process; (d) ensure that the regional coordination centres are equipped with all the necessary human, technical, physical and financial resources for fulfilling their obligations under this Directive and carrying out their tasks independently and impartially; (e) propose jointly with other regulatory authorities of a system operation region possible additional tasks and additional powers to be assigned to the regional coordination centres by the Member States of the system operation region; (f) ensure compliance with the obligations under this Directive and other relevant Union law, in particular as regards cross-border issues, and jointly identify non-compliance of the regional coordination centres with their respective obligations; where the regulatory authorities have not been able to reach an agreement within a period of four months after the start of consultations for the purpose of jointly identifying non-compliance, the matter shall be referred to ACER for a decision, pursuant to Article 6(10) of Regulation (EU) 2019/942; (g) monitor the performance of system coordination and report annually to ACER in this respect in accordance with Article 46 of Regulation (EU) 2019/943. 2. Member States shall ensure that regulatory authorities are granted the powers enabling them to carry out the duties referred to in paragraph 1 in an efficient and expeditious manner. For this purpose, the regulatory authorities shall have at least the following powers: (a) to request information from the regional coordination centres; (b) to carry out inspections, including unannounced inspections, at the premises of the regional coordination centres; (c) to issue joint binding decisions on the regional coordination centres. 3. The regulatory authority located in the Member State in which a regional coordination centre has its seat shall have the power to impose effective, proportionate and dissuasive penalties on the regional coordination centre where it does not comply with its obligations under this Directive, Regulation (EU) 2019/943 or any relevant legally binding decisions of the regulatory authority or of ACER, or shall have the power to propose that a competent court impose such penalties. Article 63 Compliance with the network codes and guidelines 1. Any regulatory authority and the Commission may request the opinion of ACER on the compliance of a decision taken by a regulatory authority with the network codes and guidelines referred to in this Directive or in Chapter VII of Regulation (EU) 2019/943. 2. ACER shall provide its opinion to the regulatory authority which has requested it or to the Commission, respectively, and to the regulatory authority which has taken the decision in question within three months of the date of receipt of the request. 3. Where the regulatory authority which has taken the decision does not comply with ACER's opinion within four months of the date of receipt of that opinion, ACER shall inform the Commission accordingly. 4. Any regulatory authority may inform the Commission where it considers that a decision relevant for cross-border trade taken by another regulatory authority does not comply with the network codes and guidelines referred to in this Directive or in Chapter VII of Regulation (EU) 2019/943 within two months of the date of that decision. 5. Where the Commission, within two months of having been informed by ACER in accordance with paragraph 3, or by a regulatory authority in accordance with paragraph 4, or, on its own initiative, within three months of the date of the decision, finds that the decision of a regulatory authority raises serious doubts as to its compatibility with the network codes and guidelines referred to in this Directive or in Chapter VII of Regulation (EU) 2019/943, the Commission may decide to examine the case further. In such a case, it shall invite the regulatory authority and the parties to the proceedings before the regulatory authority to submit observations. 6. Where the Commission takes a decision to examine the case further, it shall, within four months of the date of such decision, issue a final decision: (a) not to raise objections against the decision of the regulatory authority; or (b) to require the regulatory authority concerned to withdraw its decision on the basis that network codes and guidelines have not been complied with. 7. Where the Commission has not taken a decision to examine the case further or a final decision within the time-limits set in paragraphs 5 and 6 respectively, it shall be deemed not to have raised objections to the decision of the regulatory authority. 8. The regulatory authority shall comply with the Commission decision requiring it to withdraw its decision within two months and shall inform the Commission accordingly. 9. The Commission is empowered to adopt delegated acts in accordance with Article 67 supplementing this Directive by establishing guidelines setting out the details of the procedure to be followed for the application of this Article. Article 64 Record keeping 1. Member States shall require suppliers to keep at the disposal of the national authorities, including the regulatory authority, the national competition authorities and the Commission, for the fulfilment of their tasks, for at least five years, the relevant data relating to all transactions in electricity supply contracts and electricity derivatives with wholesale customers and transmission system operators. 2. The data shall include details on the characteristics of the relevant transactions such as duration, delivery and settlement rules, the quantity, the dates and times of execution and the transaction prices and means of identifying the wholesale customer concerned, as well as specified details of all unsettled electricity supply contracts and electricity derivatives. 3. The regulatory authority may decide to make available to market participants elements of that information provided that commercially sensitive information on individual market players or individual transactions is not released. This paragraph shall not apply to information about financial instruments which fall within the scope of Directive 2014/65/EU. 4. This Article shall not create additional obligations towards the authorities referred to in paragraph 1 for entities falling within the scope of Directive 2014/65/EU. 5. In the event that the authorities referred to in paragraph 1 need access to data kept by entities falling within the scope of Directive 2014/65/EU, the authorities responsible under that Directive shall provide them with the required data. CHAPTER VIII FINAL PROVISIONS Article 65 Level playing field 1. Measures that the Member States may take pursuant to this Directive in order to ensure a level playing field shall be compatible with the TFEU, in particular Article 36 thereof, and with Union law. 2. The measures referred to in paragraph 1 shall be proportionate, non-discriminatory and transparent. Those measures may be put into effect only following the notification to and approval by the Commission. 3. The Commission shall act on the notification referred to in paragraph 2 within two months of the receipt of the notification. That period shall begin on the day after receipt of the complete information. In the event that the Commission has not acted within that two-month period, it shall be deemed not to have raised objections to the notified measures. Article 66 Derogations 1. Member States which can demonstrate that there are substantial problems for the operation of their small connected systems and small isolated systems, may apply to the Commission for derogations from the relevant provisions of Articles 7 and 8 and of Chapters IV, V and VI. Small isolated systems and France, for the purpose of Corsica, may also apply for a derogation from Articles 4, 5 and 6. The Commission shall inform the Member States of such applications before taking a decision, taking into account respect for confidentiality. 2. Derogations granted by the Commission as referred to in paragraph 1 shall be limited in time and subject to conditions that aim to increase competition in and the integration of the internal market and to ensure that the derogations do not hamper the transition towards renewable energy, increased flexibility, energy storage, electromobility and demand response. For outermost regions within the meaning of Article 349 TFEU, that cannot be interconnected with the Union electricity markets, the derogation shall not be limited in time and shall be subject to conditions aimed to ensure that the derogation does not hamper the transition towards renewable energy. Decisions to grant derogations shall be published in the Official Journal of the European Union. 3. Article 43 shall not apply to Cyprus, Luxembourg and Malta. In addition, Articles 6 and 35 shall not apply to Malta and Articles 44, 45, 46, 47, 48, 49, 50 and 52 shall not apply to Cyprus. For the purposes of point (b) of Article 43(1), the notion \u2018undertaking performing any of the functions of generation or supply\u2019 shall not include final customers who perform any of the functions of generation and/or supply of electricity, either directly or via undertakings over which they exercise control, either individually or jointly, provided that the final customers including their shares of the electricity produced in controlled undertakings are, on an annual average, net consumers of electricity and provided that the economic value of the electricity they sell to third parties is insignificant in proportion to their other business operations. 4. Until 1 January 2025, or until a later date set out in a decision pursuant to paragraph 1 of this Article, Article 5 shall not apply to Cyprus and Corsica. 5. Article 4 shall not apply to Malta until 5 July 2027. That period may be extended for a further additional period, not exceeding eight years. The extension for a further additional period shall be made by means of a decision pursuant to paragraph 1. Article 67 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 61(5) and Article 63(9) shall be conferred on the Commission for an indeterminate period of time from 4 July 2019. 3. The delegation of power referred to in Article 61(5) and Article 63(9) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 61(5) and Article 63(9) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 68 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 69 Commission monitoring, reviewing and reporting 1. The Commission shall monitor and review the implementation of this Directive and shall submit a progress report to the European Parliament and the Council as an annex to the State of the Energy Union Report referred to in Article 35 of Regulation (EU) 2018/1999. 2. By 31 December 2025, the Commission shall review the implementation of this Directive and shall submit a report to the European Parliament and to the Council. If appropriate, the Commission shall submit a legislative proposal together with or after submitting the report. The Commission's review shall, in particular, assess whether customers, especially those who are vulnerable or in energy poverty, are adequately protected under this Directive. Article 70 Amendments to Directive 2012/27/EU Directive 2012/27/EU is amended as follows: (1) Article 9 is amended as follows: (a) the title is replaced by the following: \u2018Metering for natural gas\u2019; (b) in paragraph 1, the first subparagraph is replaced by the following: \u20181. Member States shall ensure that, in so far as it is technically possible, financially reasonable, and proportionate to the potential energy savings, for natural gas final customers are provided with competitively priced individual meters that accurately reflect the final customer's actual energy consumption and that provide information on actual time of use.\u2019; (c) paragraph 2 is amended as follows: (i) the introductory part is replaced by the following: \u20182. Where, and to the extent that, Member States implement intelligent metering systems and roll out smart meters for natural gas in accordance with Directive 2009/73/EC:\u2019; (ii) points (c) and (d) are deleted; (2) Article 10 is amended as follows: (a) the title is replaced by the following: \u2018Billing information for natural gas\u2019; (b) in paragraph 1, the first subparagraph is replaced by the following: \u20181. Where final customers do not have smart meters as referred to in Directive 2009/73/EC, Member States shall ensure, by 31 December 2014, that billing information for natural gas is reliable, accurate and based on actual consumption, in accordance with point 1.1 of Annex VII, where that is technically possible and economically justified.\u2019; (c) in paragraph 2, the first subparagraph is replaced by the following: \u20182. Meters installed in accordance with Directive 2009/73/EC shall enable the provision of accurate billing information based on actual consumption. Member States shall ensure that final customers have the possibility of easy access to complementary information on historical consumption allowing detailed self-checks.\u2019; (3) in Article 11, the title is replaced by the following: \u2018Cost of access to metering and billing information for natural gas\u2019; (4) in Article 13, the words \u2018Articles 7 to 11\u2019 are replaced by the words \u2018Articles 7 to 11a\u2019; (5) Article 15 is amended as follows: (a) paragraph 5 is amended as follows: (i) the first and second subparagraphs are deleted; (ii) the third subparagraph is replaced by the following: \u2018Transmission system operators and distribution system operators shall comply with the requirements set out in Annex XII.\u2019; (b) paragraph 8 is deleted; (6) in Annex VII, the title is replaced by the following: \u2018Minimum requirements for billing and billing information based on actual consumption of natural gas\u2019. Article 71 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Articles 2 to 5, Article 6(2) and (3), Article 7(1), point (j) and (l) of Article 8(2), Article 9(2), Article 10(2) to (12), Articles 11 to 24, Articles 26, 28 and 29, Articles 31 to 34 and 36, Article 38(2), Articles 40 and 42, point (d) of Article 46(2), Articles 51 and 54, Articles 57 to 59, Articles 61 to 63, points (1) to (3), (5)(b) and (6) of Article 70 and Annexes I and II by 31 December 2020. They shall immediately communicate the text of those provisions to the Commission. However, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with: (a) point (5)(a) of Article 70 by 31 December 2019; (b) point (4) of Article 70 by 25 October 2020. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 72 Repeal Directive 2009/72/EC is repealed with effect from 1 January 2021, without prejudice to the obligations of Member States relating to the time-limit for the transposition into national law and the date of application of the Directive set out in Annex III. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex IV. Article 73 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 6(1), Article 7 (2) to (5), Article 8(1), points (a) to (i) and (k) of Article 8(2) and Article 8(3) and (4), Article 9(1), (3), (4) and (5), Article 10(2) to (10), Articles 25, 27, 30, 35 and 37, Article 38(1), (3) and (4), Articles 39, 41, 43, 44 and 45, Article 46(1), points (a), (b) and (c) and (e) to (h) of Article 46(2), Article 46(3) to (6), Article 47 to 50, Articles 52, 53, 55, 56, 60, 64 and 65 shall apply from 1 January 2021. Points (1) to (3), (5)(b) and (6) of Article 70 shall apply from 1 January 2021. Point (5)(a) of Article 70 shall apply from 1 January 2020. Point (4) of Article 70 shall apply from 26 October 2020. Article 74 Addressees This Directive is addressed to the Member States. Done at Brussels, 5 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 288, 31.8.2017, p. 91. (2) OJ C 342, 12.10.2017, p. 79. (3) Position of the European Parliament of 26 March 2019 (not yet published in the Official Journal) and Decision of the Council of 22 May 2019. (4) Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJ L 211, 14.8.2009, p. 55). (5) Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity and repealing Directive 96/92/EC (OJ L 176, 15.7.2003, p. 37), repealed and replaced, with effect from 2 March 2011, by Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJ L 211, 14.8.2009, p. 55). (6) Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (see page 54 of this Official Journal). (7) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1). (8) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1). (9) Regulation (EU) 2019/942 of the European Parliament and of the Council of 5 June 2019 establishing a European Union Agency for the Cooperation of Energy Regulators (see page 22 of this Official Journal). (10) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94). (11) OJ L 198, 20.7.2006, p. 18. (12) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (13) OJ L 123, 12.5.2016, p. 1. (14) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (15) OJ C 369, 17.12.2011, p. 14. (16) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349). (17) Commission Implementing Regulation (EU) No 1348/2014 of 17 December 2014 on data reporting implementing Article 8(2) and Article 8(6) of Regulation (EU) No 1227/2011 of the European Parliament and the Council on wholesale energy market integrity and transparency (OJ L 363, 18.12.2014, p. 121). (18) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19). (19) Directive (EU) 2018/2001 of the European Parliament and the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). (20) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (21) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29). (22) Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35). (23) Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Directive on consumer ADR) (OJ L 165, 18.6.2013, p. 63). (24) Commission Regulation (EU) 2017/1485 of 2 August 2017 establishing a guideline on electricity transmission system operation (OJ L 220, 25.8.2017, p. 1). (25) Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1). (26) Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, p. 46). ANNEX I MINIMUM REQUIREMENTS FOR BILLING AND BILLING INFORMATION 1. Minimum information to be contained on the bill and in the billing information 1.1. The following key information shall be prominently displayed to final customers in their bills, distinctly separate from other parts of the bill: (a) the price to be paid and a breakdown of the price where possible, together with a clear statement that all energy sources may also benefit from incentives that were not financed through the levies indicated in the breakdown of the price; (b) the date on which payment is due. 1.2. The following key information shall be prominently displayed to final customers in their bills and billing information, distinctly separate from other parts of the bill and billing information: (a) electricity consumption for the billing period; (b) the name and contact details of the supplier, including a consumer support hotline and email address; (c) the tariff name; (d) the end date of the contract, if applicable; (e) the information on the availability and benefits of switching; (f) the final customer's switching code or unique identification code for the final customer's supply point; (g) information on final customers' rights as regards out-of-court dispute settlement, including the contact details of the entity responsible pursuant to Article 26; (h) the single point of contact referred to in Article 25; (i) a link or reference to where comparison tools referred to in Article 14 can be found. 1.3. Where bills are based on actual consumption or remote reading by the operator, the following information shall be made available to final customers in, with or signposted to within their bills and periodic settlement bills: (a) comparisons of the final customer's current electricity consumption with the final customer's consumption for the same period in the previous year in graphic form; (b) contact information for consumer organisations, energy agencies or similar bodies, including website addresses, from which information may be obtained on available energy efficiency improvement measures for energy-using equipment; (c) comparisons with an average normalised or benchmarked final customer in the same user category. 2. Frequency of billing and the provision of billing information: (a) billing on the basis of actual consumption shall take place at least once a year; (b) where the final customer does not have a meter that allows remote reading by the operator, or where the final customer has actively chosen to disable remote reading in accordance with national law, accurate billing information based on actual consumption shall be made available to the final customer at least every six months, or once every three months, if requested or where the final customer has opted to receive electronic billing; (c) where the final customer does not have a meter that allows remote reading by the operator, or where the final customer has actively chosen to disable remote reading in accordance with national law, the obligations in points (a) and (b) may be fulfilled by means of a system of regular self-reading by the final customer, whereby the final customer communicates readings from the meter to the operator; billing or billing information may be based on estimated consumption or a flat rate only where the final customer has not provided a meter reading for a given billing interval; (d) where the final customer has a meter that allows remote reading by the operator, accurate billing information based on actual consumption shall be provided at least every month; such information may also be made available via the internet, and shall be updated as frequently as allowed by the measurement devices and systems used. 3. Breakdown of the final customer's price The customer's price is the sum of the following three components: the energy and supply component, the network component (transmission and distribution) and the component comprising taxes, levies, fees and charges. Where a breakdown of the final customer's price is presented in bills, the common definitions of the three components in that breakdown established under Regulation (EU) 2016/1952 of the European Parliament and of the Council (1) shall be used throughout the Union. 4. Access to complementary information on historical consumption Member States shall require that, to the extent that complementary information on historical consumption is available, such information is made available, at the request of the final customer, to the supplier or service provider designated by the final customer. Where the final customer has a meter that allows remote reading by the operator installed, the final customer shall have easy access to complementary information on historical consumption allowing detailed self-checks. Complementary information on historical consumption shall include: (a) cumulative data for at least the three previous years or the period since the start of the electricity supply contract, if that period is shorter. The data shall correspond to the intervals for which frequent billing information has been produced; and (b) detailed data according to the time of use for any day, week, month and year, which is made available to the final customer without undue delay via the internet or the meter interface, covering the period of at least the previous 24 months or the period since the start of the electricity supply contract, if that period is shorter. 5. Disclosure of energy sources Suppliers shall specify in bills the contribution of each energy source to the electricity purchased by the final customer in accordance with the electricity supply contract (product level disclosure). The following information shall be made available to final customers in, with, or signposted to within their bills and billing information: (a) the contribution of each energy source to the overall energy mix of the supplier (at national level, namely in the Member State in which the electricity supply contract has been concluded, as well as at the level of the supplier if the supplier is active in several Member States) over the preceding year in a comprehensible and clearly comparable manner; (b) information on the environmental impact, in at least terms of CO2 emissions and the radioactive waste resulting from the electricity produced by the overall energy mix of the supplier over the preceding year. As regards point (a) of the second subparagraph, with respect to electricity obtained via an electricity exchange or imported from an undertaking situated outside the Union, aggregate figures provided by the exchange or the undertaking in question over the preceding year may be used. For the disclosure of electricity from high efficiency cogeneration, guarantees of origin issued under Article 14(10) of Directive 2012/27/EU may be used. The disclosure of electricity from renewable sources shall be done by using guarantees of origin, except in the cases referred to in points (a) and (b) of Article 19(8) of Directive (EU) 2018/2001. The regulatory authority or another competent national authority shall take the necessary steps to ensure that the information provided by suppliers to final customers pursuant to this point is reliable and is provided at a national level in a clearly comparable manner. (1) Regulation (EU) 2016/1952 of the European Parliament and of the Council of 26 October 2016 on European statistics on natural gas and electricity prices and repealing Directive 2008/92/EC (OJ L 311, 17.11.2016, p. 1). ANNEX II SMART METERING SYSTEMS 1. Member States shall ensure the deployment of smart metering systems in their territories that may be subject to an economic assessment of all of the long-term costs and benefits to the market and the individual consumer or which form of smart metering is economically reasonable and cost-effective and which time frame is feasible for their distribution. 2. Such assessment shall take into consideration the methodology for the cost-benefit analysis and the minimum functionalities for smart metering systems provided for in Commission Recommendation 2012/148/EU (1) as well as the best available techniques for ensuring the highest level of cybersecurity and data protection. 3. Subject to that assessment, Member States or, where a Member State has so provided, the designated competent authority, shall prepare a timetable with a target of up to ten years for the deployment of smart metering systems. Where the deployment of smart metering systems is assessed positively, at least 80 % of final customers shall be equipped with smart meters either within seven years of the date of the positive assessment or by 2024 for those Member States that have initiated the systematic deployment of smart metering systems before 4 July 2019. (1) Commission Recommendation 2012/148/EU of 9 March 2012 on preparations for the roll-out of smart metering systems (OJ L 73, 13.3.2012, p. 9). ANNEX III TIME-LIMIT FOR TRANSPOSITION INTO NATIONAL LAW AND DATE OF APPLICATION (REFERRED TO IN ARTICLE 72) Directive Time-limit for transposition Date of application Directive 2009/72/EC of the European Parliament and of the Council (OJ L 211, 14.8.2009, p. 55) 3 March 2011 3 September 2009 ANNEX IV CORRELATION TABLE Directive 2009/72/EC This Directive Article 1 Article 1 Article 2 Article 2 \u2014 Article 3 Articles 33 and 41 Article 4 \u2014 Article 5 Article 32 Article 6 Article 34 Article 7 Article 7 Article 8 Article 8 \u2014 Article 3(1) Article 9(1) Article 3(2) Article 9(2) Article 3(6) Article 9(3) Article 3(15) Article 9(4) Article 3(14) Article 9(5) Article 3(16) \u2014 Article 3(4) Article 10(1) Annex I. 1(a) Article 10(2) and (3) Annex I. 1(b) Article 10(4) Annex I. 1(c) Article 10(5) Annex I. 1(d) Article 10(6) and (8) \u2014 Article 10(7) Annex I. 1(f) Article 10(9) Annex I. 1(g) Article 10(10) Article 3(7) Article 10(11) Annex I. 1(j) Article 10(12) Article 3(10) \u2014 Article 4 \u2014 Article 5 \u2014 Article 6 \u2014 \u2014 Article 11 Article 3(5)(a) and Annex I. 1(e) Article 12 \u2014 Article 13 \u2014 Article 14 \u2014 Article 15 \u2014 Article 16 \u2014 Article 17 \u2014 Article 18 Article 3(11) Article 19(1) \u2014 Article 19(2) to (6) \u2014 Article 20 \u2014 Article 21 \u2014 Article 22 \u2014 Article 23 \u2014 Article 24 Article 3(12) Article 25 Article 3(13) Article 26 Article 3(3) Article 27 Article 3(7) Article 28(1) Article 3(8) Article 28(2) \u2014 Article 29 Article 24 Article 30 Article 25 Article 31 \u2014 Article 32 \u2014 Article 33 \u2014 Article 34 Article 26 Article 35 \u2014 Article 36 Article 27 Article 37 Article 28 Article 38 Article 29 Article 39 Article 12 Article 40(1) \u2014 Article 40(2) to (8) Article 16 Article 41 Article 23 Article 42 Article 9 Article 43 Article 13 Article 44 Article 14 Article 45 Article 17 Article 46 Article 18 Article 47 Article 19 Article 48 Article 20 Article 49 Article 21 Article 50 Article 22 Article 51 Article 10 Article 52 Article 11 Article 53 \u2014 Article 54 Article 30 Article 55 Article 31 Article 56 Article 35 Article 57 Article 36 Article 58 Article 37(1) Article 59(1) Article 37(2) Article 59(2) Article 37(4) Article 59(3) \u2014 Article 59(4) Article 37(3) Article 59(5) Article 37(5) Article 59(6) Article 37(6) Article 59(7) Article 37(8) \u2014 Article 37(7) Article 59(8) \u2014 Article 59(9) Article 37(9) Article 59(10) Article 37(10) Article 60(1) Article 37(11) Article 60(2) Article 37(12) Article 60(3) Article 37(13) Article 60(4) Article 37(14) Article 60(5) Article 37(15) Article 60(6) Article 37(16) Article 60(7) Article 37(17) Article 60(8) Article 38 Article 61 \u2014 Article 62 Article 39 Article 63 Article 40 Article 64 Article 42 \u2014 Article 43 Article 65 Article 44 Article 66 Article 45 \u2014 \u2014 Article 67 Article 46 Article 68 Article 47 Article 69 \u2014 Article 70 Article 49 Article 71 Article 48 Article 72 Article 50 Article 73 Article 51 Article 74 \u2014 Annex I, points 1 to 4 Article 3(9) Annex I. 5 Annex I. 2 Annex II \u2014 Annex III \u2014 Annex IV", "summary": "Internal market in electricity (from 2021) Internal market in electricity (from 2021) SUMMARY OF: Directive (EU) 2019/944 on common rules for the internal market for electricity WHAT IS THE AIM OF THE DIRECTIVE? It outlines rules for the generation, transmission, distribution, supply and storage of electricity, together with consumer protection aspects, aiming to create integrated competitive, consumer-centred, flexible, fair and transparent electricity markets in the EU. Among other things, it contains rules on retail markets for electricity, whereas Regulation (EU) 2019/943, which was adopted at the same time, mainly contains rules on the wholesale market and network operation. It repeals Directive 2009/72/EC (see summary Internal market in electricity) as of 1 January 2021. KEY POINTS Customer rights The directive clarifies and reinforces existing customer rights and introduces new ones: right to freely choose a supplier and restrictions on switching and exit fees, except where fixed-price fixed-term contracts are terminated before their end date; right to access to at least one price comparison tool fulfilling certain trust requirements; compliant privately run tools may be issued a trust mark; right to join a citizen energy community while retaining full consumer rights, including the right to leave the community without penalties; right to a dynamic price contract (based on prices in the spot or day-ahead market) from at least one supplier and every supplier with more than 200,000 customers, and right to be provided information about the opportunities and risks involved; right to an aggregation contract independent of electricity supply; right to produce, consume, store and sell electricity, individually or through an aggregator*; right to request the installation of a smart meter within 4 months, while EU countries must ensure a roll-out of smart metering systems, except where it is not yet considered cost-effective; right of energy-poor or vulnerable customers to targeted protection, but with regulated price-setting only allowed under certain conditions; right of customers facing disconnection to be given information about alternatives, such as payment plans or a moratorium, well in advance. Billing Bills should be clear, correct, concise and presented in a way that makes comparisons easy. Billing information should be provided at least every 6 months or once every 3 months, if requested, or, where the final customer has opted to receive electronic billing, and at least once a month if meters can be read remotely. Aggregators EU countries must: ensure that aggregators can offer aggregation contracts to customers without those customers having to obtain the consent of their supplier; ensure the fair participation of aggregators in all electricity markets and that transmission and distribution system operators treat aggregators equally with other market participants, including when they procure services; establish transparent rules assigning roles and responsibilities to all market participants and set out rules for data exchange between market participants; establish rules for compensation between aggregators and suppliers where the activation of demand response causes an imbalance; such compensation shall strictly cover resulting costs and the calculation of such compensation may take into account the systemic benefits of demand response. Citizen energy communities are shareholder- or member-controlled entities based on voluntary and open participation, which have the right to engage in generation, distribution, supply, consumption, energy efficiency services or charging services for electric vehicles, or provide other energy services to its members or shareholders; have the right to be connected to distribution grids and be treated in a non-discriminatory manner in terms of regulation or access to all electricity markets; have the right to share their own electricity production with their members in accordance with a cost-benefit analysis of distributed energy resources; have the right, where so permitted by the EU country in question, to own, establish, purchase or lease distribution networks subject to the applicable regulations. Access to data and interoperability The directive updates rules on access to metering and consumption/generation data by network operators, consumers, suppliers and service providers. Moreover, it envisages that the European Commission will set up in secondary law interoperability rules to facilitate the exchange of data. Data managers must ensure non-discriminatory access to data from smart metering systems while complying with the data protection rules. Electromobility EU countries must establish a regulatory framework to facilitate the connection of electric vehicle recharging points to the distribution network. Distribution system operators* (DSOs) would only be allowed to own, develop, manage or operate recharging points if no other body has expressed interest in an open tendering procedure, subject to regulatory approval and in line with third-party access rules. Distribution system operators (DSOs): are responsible for ensuring the long-term ability of the system to meet demands for the distribution of electricity, including the cost-efficient integration of new electricity generation installations and especially the ones which produce electricity from renewable sources, as well as for providing system users with the information needed for efficient access and use of the system; must publish network development plans setting out the planned investments for the following 5 to 10 years; where part of a vertically integrated undertaking, must be independent at least in terms of its legal form, organisation and decision-making from other activities not relating to distribution; are not allowed to own, develop, manage or operate storage facilities except where certain specific conditions are met. Transmission system operators* (TSOs): must ensure the long-term ability of the system to meet demands for the transmission of electricity, in close cooperation with neighbouring TSOs and DSOs. shall manage the secure operation of the system including keeping the balance between electricity supply and demand. are not allowed to own, develop, manage or operate energy storage facilities, under similar conditions as apply to DSOs. National energy regulators: must cooperate with neighbouring regulators and with the Agency for cooperation between EU energy regulators on issues including risk-preparedness, allocation of cross-border capacity and to ensure an adequate level of interconnector capacities. have revised oversight responsibility for regional operating centres and other entities at regional level. Clean energy This directive is part of the Clean Energy for all Europeans package. FROM WHEN DOES THE DIRECTIVE APPLY? It applies from 1 January 2021. Directive (EU) 2019/944 revises and replaces Directive 2009/72/EC and has to become law in the EU countries by 31 December 2020. The original Directive 2009/72/EC had to become law in the EU countries by 2011. BACKGROUND For more information, see: Energy union for Europe (European Council) Clean energy for all Europeans (European Commission). KEY TERMS Aggregator: a natural or legal person who combines multiple customer loads or generated electricity for sale, purchase or auction in any electricity market. Distribution system operator: a natural or legal person responsible for operating and developing the electricity distribution system in an area, and its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the distribution of electricity. Transmission system operator: a natural or legal person who is responsible for operating and developing the electricity transmission system in an area, and its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the transmission of electricity. MAIN DOCUMENT Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU (recast) (OJ L 158, 14.6.2019, pp. 125-199) RELATED DOCUMENTS Regulation (EU) 2019/941 of the European Parliament and of the Council of 5 June 2019 on risk-preparedness in the electricity sector and repealing Directive 2005/89/EC (OJ L 158, 14.6.2019, pp. 1-21) Regulation (EU) 2019/942 of the European Parliament and of the Council of 5 June 2019 establishing a European Union Agency for the Cooperation of Energy Regulators (OJ L 158, 14.6.2019, pp. 22-53) Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (OJ L 158, 14.6.2019, pp. 54-124) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, pp. 1-77) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, pp. 82-209) Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJ L 211, 14.8.2009, pp. 55-93) last update 01.10.2019"}
{"article": "19.7.2021 EN Official Journal of the European Union L 256/3 COUNCIL REGULATION (EU) 2021/1173 of 13 July 2021 on establishing the European High Performance Computing Joint Undertaking and repealing Regulation (EU) 2018/1488 THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 187 and the first paragraph of Article 188 thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the European Economic and Social Committee (2), Whereas: (1) Regulation (EU) 2021/695 of the European Parliament and of the Council (3) establishes Horizon Europe \u2013 the Framework Programme for Research and Innovation (\u2018Horizon Europe\u2019). Parts of Horizon Europe may be implemented through European Partnerships, with private and/or public sector partners, in order to achieve the greatest possible impact of Union funding and the most effective contribution to the Union\u2019s policy objectives. (2) In accordance with Regulation (EU) 2021/695 support may be provided to Joint Undertakings established in the framework of Horizon Europe. Such partnerships should be implemented only where other parts of Horizon Europe, including other forms of European Partnerships, would not achieve its objectives or would not generate the necessary expected impacts, and if justified by a long-term perspective and high degree of integration. The conditions under which such partnerships are created are specified in that Regulation. (3) Regulation (EU) 2021/694 of the European Parliament and of the Council (4) establishes the Digital Europe Programme. The Digital Europe Programme supports the implementation of projects of common interest which aim at the acquisition, deployment and operation of a world-class supercomputing, quantum and data infrastructure, at federation and interconnection, and at widening the use of supercomputing services and the development of key skills. (4) Regulation (EU) 2021/1153 of the European Parliament and of the Council (5) establishes the Connecting Europe Facility. The Connecting Europe Facility enables projects of common interest to be prepared and implemented within the framework of the trans-European networks policy in the sectors of transport, telecommunications and energy. In particular, the Connecting Europe Facility supports the implementation of those projects of common interest which aim at the development and construction of new infrastructures and services, or at the upgrading of existing infrastructures and services, in the transport, telecommunications and energy sectors. The Connecting Europe Facility contributes to supporting digital connectivity infrastructures of common interest bringing significant spillover societal benefits. (5) The Communication from the Commission of 19 February 2020 entitled \u2018A European Strategy for Data\u2019 outlines Europe\u2019s strategy for policy measures and investments to enable the data economy for the coming five years. It emphasises the creation of European public common data spaces that will boost growth and create value. Support for the creation of such common European data spaces and federated, secure cloud infrastructures would ensure that more data becomes available for use in the economy and society, while keeping companies and individuals who generate the data in control. High Performance Computing and quantum computing are essential components of the seamless provision of computing resources with different performance characteristics required to maximise the growth and exploitation of European public common data spaces and federated, secure cloud infrastructures for public, industrial and scientific applications. (6) The Communication from the Commission of 19 February 2020 entitled \u2018Shaping Europe\u2019s digital future\u2019 presents Europe\u2019s digital strategy and focuses on key objectives to ensure that digital solutions help Europe to pursue its own way towards a digital transformation that works for the benefit of people. Among the key actions it proposes is investing in building and deploying cutting-edge joint digital capacities, including in supercomputing and quantum technologies, and expanding Europe\u2019s supercomputing capacity to develop innovative solutions for medicine, transport and the environment. (7) The Communication from the Commission of 10 March 2020 entitled \u2018A new Industrial Strategy for Europe\u2019 reflects an ambitious industrial strategy for Europe to lead the twin transitions towards climate neutrality and digital leadership. The Communication stresses the support, among others, to the development of key enabling technologies that are strategically important for Europe\u2019s industrial future, including High Performance Computing and quantum technologies. (8) The Communication from the Commission of 27 May 2020 entitled \u2018Europe\u2019s moment: Repair and Prepare for the Next Generation\u2019 identified a number of strategic digital capacities and capabilities that included High Performance Computers and quantum technologies as a priority in the Recovery and Resilience Facility, InvestEU and the Strategic Investment Facility. (9) Europe\u2019s leading role in the data economy, its scientific excellence, and its industrial strength increasingly depend on its ability to develop key High Performance Computing technologies, to provide access to world-class supercomputing and data infrastructures, and to maintain its present leadership in High Performance Computing applications. High Performance Computing is a mainstream technology for the digital transformation of the European economy, enabling many traditional industrial sectors to innovate with higher value products and services. In combination with other advanced digital technologies such as artificial intelligence, big data and cloud technologies, High Performance Computing is paving the way towards innovative societal and industrial applications in critical areas for Europe such as personalised medicine, weather forecast and climate change, smart and green development and transport, new materials for clean energy, drug design and virtual testing, sustainable agriculture, or engineering and manufacturing. (10) High Performance Computing is a strategic resource for policy making, powering applications that provide the means to understand and design efficient solutions to address many complex global challenges and for crisis management. High Performance Computing contributes to key policies such as the European Green Deal with models and tools for transforming the increasing number of complex environmental challenges into opportunities for social innovation and economic growth. An example is the Destination Earth initiative announced in the Communications from the Commission of 11 December 2019 entitled \u2018The European Green Deal\u2019, and of 19 February 2020 entitled \u2018A European strategy for data\u2019 and \u2018Shaping Europe\u2019s digital future\u2019. (11) Global events such as the COVID-19 pandemic have shown the importance of investing in High Performance Computing and health-related modelling platforms and tools, as they are playing a key role in the fight against the pandemic, often in combination with other digital technologies such as big data and artificial intelligence. High Performance Computing is being used to accelerate the identification and production of treatments, including vaccines, to predict the virus\u2019 spread, to help plan the distribution of medical supplies and resources, and to simulate post-epidemic exit measures in order to evaluate different scenarios. High Performance Computing modelling platforms and tools are critical tools for the current and future pandemics, and they will play a key role in health and personalised medicine. (12) Council Regulation (EU) 2018/1488 (6) established the European High Performance Computing Joint Undertaking (\u2018EuroHPC Joint Undertaking\u2019) with a mission to develop, deploy, extend and maintain in the Union an integrated world-class supercomputing and data infrastructure and to develop and support a highly competitive and innovative High Performance Computing ecosystem. (13) In light of developments in High Performance Computing, a revision of Regulation (EU) 2018/1488 to ensure the continuation of the initiative is necessary in order to define a new mission and objectives for the EuroHPC Joint Undertaking, taking into consideration the analysis of the key socioeconomic and technological drivers affecting the future evolution of High Performance Computing and data infrastructures, technologies and applications in the Union and worldwide, and the lessons learnt from the current activities of the EuroHPC Joint Undertaking. The revision would also allow for the alignment of the EuroHPC Joint Undertaking\u2019s rules with the new legal framework, in particular Regulation (EU) 2021/695, as well as Regulations (EU) 2021/694 and (EU) 2021/1153. (14) In order to equip the Union with the computing performance needed to maintain its research and industrial capacities at a leading edge, Member States\u2019 investment in High Performance Computing and quantum computing should be coordinated and the industrial and market take-up of High Performance Computing and quantum computing technologies be reinforced both in the public and private sectors. The Union should increase its effectiveness in turning the technology developments into demand-oriented and application-driven European High Performance Computing and quantum computing systems of the highest quality, establishing an effective link between technology supply, co-design with users, and a joint procurement of world-class systems, and creating a world-class ecosystem in High Performance Computing and quantum computing technologies and applications across Europe. At the same time, the Union should provide an opportunity for its supply industry to leverage on such investments, leading to their uptake in large-scale and emerging application fields such as personalised medicine, climate change, connected and automated driving or other lead markets that are underpinned by artificial intelligence, blockchain technologies, edge computing or more broadly by the digitalisation of the European industry. (15) In order for the Union and its Member States to achieve leadership in key digital technologies such as High Performance Computing and quantum computing, they should invest in next generation low-power and energy efficient supercomputing technologies, innovative software and advanced supercomputing systems for exascale and post-exascale computing and quantum computing, and for innovative supercomputing and data applications. This should allow the European supply industry to thrive in a wide range of key technology and application areas that reach beyond High Performance Computing and quantum computing and, in the long run, feed broader ICT markets with such technologies. It would also support the High Performance Computing and quantum computing science and user industry to undergo a digital transformation and boost its innovation potential. (16) Pursuing a common strategic Union vision in High Performance Computing and quantum computing is essential for realising the ambition of the Union and of its Member States to ensure a leading role in the digital economy. The objective would be to establish in Europe a world-leading hyper-connected, federated and secure High Performance Computing and quantum computing service and data infrastructure ecosystem, and to be in a position to produce innovative and competitive High Performance Computing and quantum computing systems based on a supply chain that is more resilient and will ensure the availability of components, technologies and knowledge, limiting the risk of disruptions. (17) A Joint Undertaking represents the best instrument capable of implementing the strategic EU vision in High Performance Computing and quantum computing, thus ensuring that the Union enjoys world-class supercomputing, quantum computing and data capabilities according to its economic potential, matching the needs of European users. The Joint Undertaking is the best instrument to overcome the present limitations, while offering the highest economic, societal, and environmental impact and best safeguarding the Union\u2019s interests in High Performance Computing and quantum computing. It can pool resources from the Union, Member States and third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility and the private sector. It can implement a procurement framework and operate world-class High Performance Computing and quantum computing systems. It can launch research and innovation programmes for developing European technologies and their subsequent integration in world-class supercomputing systems. (18) The Joint Undertaking will be part of the Institutionalised Partnerships portfolio under Horizon Europe which should strive to strengthen Union\u2019s scientific capacities to deal with emerging threats and future challenges in a reinforced European Research Area, secure sustainability-driven Union\u2019s value chains and Union\u2019s strategic autonomy, and enhance the uptake of innovative solutions addressing climate, environmental, health and other global societal challenges in line with Union strategic priorities, including to reach climate neutrality in the Union by 2050. (19) The Joint Undertaking should be financed by the Union programmes under the multiannual financial framework for the years 2021 to 2027 (the \u2018MFF 2021-2027\u2019). It should be established in 2021 and operate until 31 December 2033 to equip the Union with a world-class federated, secure and hyper-connected supercomputing infrastructure, and to develop the necessary technologies, applications and skills for reaching exascale capabilities around 2022-2024, and post exascale around 2025 \u2013 2027, while promoting a world-class European High Performance Computing and quantum computing innovation ecosystem. In accordance with Article 10(2)(c) of Regulation (EU) 2021/695, Joint Undertakings are to have a clear life cycle approach. In order to adequately protect the financial interests of the Union, the Joint Undertaking should be set up for a period ending 31 December 2033 to allow it to exercise its responsibilities with regard to grant implementation until the last indirect actions launched have been completed and with regard to finalising the activities related to the operation of the EuroHPC supercomputers. (20) The public-private partnership in the form of the Joint Undertaking should combine the financial and technical means that are essential to master the complexity of the ever escalating pace of innovation in this area. Therefore, the members of the Joint Undertaking should be the Union, Member States and third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility agreeing on a joint European initiative in High Performance Computing and quantum computing, and associations representing their constituent entities and other organisations with an explicit and active engagement to produce research and innovation results, to develop and deploy high performance computing or quantum computing capabilities, or contributing to address the skills gap and keep the know-how in the field of High Performance Computing and quantum computing in Europe. The Joint Undertaking should be open to new members. (21) In accordance with Annex III to Regulation (EU) 2021/695, the financial contributions from members other than the Union should be at least equal to 50 % and should be able to reach up to 75 % of the aggregated Joint Undertaking budgetary commitments. Conversely, the Union contribution, including any additional funds from third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility, should not exceed 50 % of the aggregated Joint Undertaking budgetary commitments. (22) The Union contribution should cover the administrative costs of the Joint Undertaking. (23) In accordance with point (c) of Article 10(1) of Regulation (EU) 2021/695, the Joint Undertaking is to implement a central management of all financial contributions through a coordinated approach. Accordingly, each Participating State should conclude one or more administrative agreements with the Joint Undertaking laying down the coordination mechanism for the payment of and reporting on contributions to applicants established in that Participating State. In order to ensure coherence with their national strategic priorities, Participating States should be provided with a right of veto over the use of their national financial contributions for applicants established in those Participating States. In order to minimise the administrative burden for beneficiaries, achieve simplification and ensure a more efficient implementation, each Participating State should strive to synchronise its payment schedule, reporting and audits with those of the Joint Undertaking and to converge its cost eligibility with Horizon Europe rules. Beneficiaries established in Participating States that entrusted the payment activities to the Joint Undertaking should sign a single grant agreement with the Joint Undertaking following Horizon Europe rules. (24) With a view to regaining a leading position in High Performance Computing technologies, and developing a full High Performance Computing and quantum computing ecosystem for the Union, in 2014, the industrial and research stakeholders in the European Technology Platform for High Performance Computing (ETP4HPC) Association established a contractual public private partnership with the Union. Its mission is to build a European world-class High Performance Computing technology value chain that would be globally competitive, fostering synergies between the three main components of the High Performance Computing ecosystem, namely technology development, applications and supercomputing infrastructure. Considering its expertise, and its role in bringing together the relevant private stakeholders in High Performance Computing, the ETP4HPC should be eligible for membership in the Joint Undertaking. (25) With a view to strengthening the data value chain, enhancing community building around data and setting the grounds for a thriving data-driven economy in the Union, in 2014, the industrial and research stakeholders in the Big Data Value Association (BDVA) established a contractual public private partnership with the Union. In 2020 BDVA changed its name to Data, AI and Robotics (DAIRO). Considering its expertise and its role in bringing together the relevant private stakeholders of big data, DAIRO should be eligible for membership in the Joint Undertaking. (26) The private associations ETP4HPC and DAIRO have expressed, in writing, their willingness to contribute to the Joint Undertaking\u2019s multiannual strategic programme and bring their expertise into the realisation of the objectives of the Joint Undertaking. It is appropriate that those private associations accept the Statutes set out in the Annex to this Regulation by means of a letter of endorsement. (27) The Joint Undertaking should address clearly defined topics that would enable academia and European industries at large to design, develop and use the most innovative technologies in High Performance Computing and quantum computing, and to establish an integrated and federated, secure networked infrastructure across the Union with world-class High Performance Computing and quantum computing capability, high-speed connectivity and leading-edge applications and data and software services for its scientists and for other lead users from industry, including small and medium-sized enterprises (SMEs) and the public sector. The Joint Undertaking should aim at the development and use of top class technologies and infrastructures, addressing the demanding requirements of European scientific, industrial and public sector users. (28) The mission of the Joint Undertaking should be structured in one administrative pillar and six technical pillars addressing respectively the infrastructure activities, the activities federating the supercomputing services, the technology-related activities, the supercomputing applications related activities, the activities to widen the usage and skills, and the international cooperation activities. The Digital Europe Programme should be used to fund the infrastructure pillar, part of the federation of supercomputing services pillar and the widening usage and skills pillar. The Connecting Europe Facility should be used to fund the remaining activities of the federation of supercomputing services pillar, i.e. the interconnection of the High Performance Computing, quantum computing and data resources, as well as the interconnection with the Union\u2019s common European data spaces and secure cloud infrastructures. Horizon Europe should be used to fund the technology pillar, the application pillar and the international cooperation pillar. (29) The Joint Undertaking should be able to cooperate with the Partnership for Advanced Computing in Europe (PRACE) for providing and managing access to a federated and interconnected supercomputing and data infrastructure and its services, as well as for training facilities and skills development opportunities. It should also be able to cooperate with the G\u00c9ANT network for the connectivity between the supercomputers of the Joint Undertaking, as well as with other European supercomputing and data infrastructures. (30) The Joint Undertaking should contribute to reducing the specific skills gap across the Union by engaging in awareness raising measures and assisting in the building of new knowledge and human capital. This includes the design and support of specific educational and training activities in close cooperation with the relevant public and private actors. (31) In line with the external policy objectives and international commitments of the Union, the Joint Undertaking should facilitate cooperation between the Union and international actors by defining a cooperation strategy, including identifying and promoting areas for cooperation in research and development and skills development and implementing actions where there is a mutual benefit, as well as ensuring an access policy of respective High Performance Computing and quantum computing capabilities and applications mainly based on reciprocity. (32) The Joint Undertaking should aim at promoting the exploitation of any resulting High Performance Computing technologies in the Union. It should also aim at safeguarding the investments in the supercomputers it acquires. In doing so, it should take appropriate measures to ensure the security of the supply chain of acquired technologies that should cover the whole lifetime of these supercomputers. (33) The Joint Undertaking should lay the ground for a longer-term vision and build the first hybrid High Performance Computing infrastructure in Europe, integrating classical computing architectures with quantum computing devices. Structured and coordinated financial support at European level is necessary to help research teams and European industries produce world-class results to ensure the fast and broad industrial exploitation of European research and technology across the Union, generating important spillovers for society, to share risk-taking and joining of forces by aligning strategies and investments towards a common European interest. (34) In order to achieve its objectives to design, develop and use the most innovative technologies in High Performance Computing and quantum computing, the Joint Undertaking should provide financial support in particular in the form of grants and procurement following open and competitive calls for proposals and calls for tenders based on annual work programmes. Such financial support should be targeted in particular at proven market failures that prevent the development of the programme concerned, should not crowd out private investments and should have an incentive effect in that it changes the behaviour of the recipient. (35) In order to achieve its objectives to increase the innovation potential of industry, and in particular of SMEs, to contribute to reducing the specific skills gap, to support the increase of knowledge and human capital and to upraise High Performance Computing and quantum computing capabilities, the Joint Undertaking should support the creation, and in particular the networking and coordination, of national High Performance Computing Competence Centres across Participating States. Those competence centres should provide High Performance Computing and quantum computing services to industry, academia and public administrations on their demand. They should primarily promote and enable access to the High Performance Computing innovation ecosystem, facilitate access to the supercomputers and quantum computers, address the significant shortages in skilled technical experts by undertaking awareness raising, training and outreach activities, and embark on networking activities with stakeholders and other national High Performance Computing Competence Centres to foster wider innovations, for example by exchanging and promoting best practice use cases or application experiences, by sharing their training facilities and experiences, by facilitating the co-development and exchange of parallel codes, or by supporting the sharing of innovative applications and tools for public and private users, in particular SMEs. (36) The Joint Undertaking should provide a demand-oriented and user-driven framework and enable a co-design approach for the acquisition of an integrated, world-class federated, secure and hyper-connected supercomputing and quantum computing service and data infrastructure in the Union, in order to equip users with the strategic computation resource they need to develop new, innovative solutions and to solve societal, environmental, economic and security challenges. For that purpose, the Joint Undertaking should contribute to the acquisition of world-class supercomputers. The supercomputers of the Joint Undertaking, including quantum computers, should be installed in a Participating State that is a Member State. (37) For a cost effective implementation of the Joint Undertaking\u2019s mission to develop, deploy, extend and maintain in the Union a world-leading supercomputing ecosystem, the Joint Undertaking should seize the opportunity to upgrade the supercomputers it owns, where appropriate. Thus, the upgrades should lead to an extension of the supercomputers\u2019 lifetime, increase the operational performance, and provide new functionalities to address the evolution of user needs. For the purpose of upgrading its supercomputers, the Joint Undertaking should be able to launch a call for expressions of interest as part of the infrastructure pillar. The calls for expression of interest should define the specific eligibility conditions that should apply to a hosting entity which is already hosting a EuroHPC supercomputer. (38) The Joint Undertaking should hyper-connect all the supercomputers and data infrastructures it owns or co-owns with state-of-the-art networking technologies, making them widely accessible across the Union, and should interconnect and federate its supercomputing and quantum computing data infrastructure, as well as national, regional and other computing infrastructures with a common platform. The Joint Undertaking should also ensure the interconnection of the federated, secure supercomputing, and quantum computing service and data infrastructures with the common European data spaces, including the European Open Science Cloud, and federated, secure cloud infrastructures announced in the Communication from the Commission of 19 February 2020 entitled \u2018A European Strategy for Data\u2019, for seamless service provisioning to a wide range of public and private users across Europe. (39) Horizon Europe and the Digital Europe Programme should, respectively, contribute to the closing of the research and innovation divide within the Union and to deploying wide-range supercomputing capabilities by promoting synergies with the European Regional Development Fund (ERDF), the European Social Fund+ (ESF+), the European Maritime, Fisheries and Aquaculture Fund (EMFAF) and the European Agricultural Fund for Rural Development (EAFRD), as well as the Recovery and Resilience Facility (RRF). Therefore, the Joint Undertaking should seek to develop close interactions with those funds which can specifically help to strengthen local, regional and national research and innovation capabilities. (40) The Joint Undertaking should provide a favourable framework for Participating States that are Member States to use financial contributions under the programmes co-financed by ERDF, ESF+, EMFAF and EAFRD for the acquisition of High Performance Computing and quantum computing and data infrastructures and their interconnection. The use of those financial contributions in the Joint Undertaking activities is essential for developing in the Union an integrated, federated, secure and hyper-connected world-class High Performance Computing, quantum computing service and data infrastructure, since the benefits for such infrastructure extend well beyond the users of the Member States. If Member States decide to use those financial contributions for the activities of the Joint Undertaking, those contributions should be considered as national contributions of the Participating States that are Member States to the budget of the Joint Undertaking, provided that Article 106 and other applicable provisions of Regulation (EU) 2021/1060 of the European Parliament and of the Council (7) and the fund-specific regulations are complied with. (41) The Joint Undertaking can facilitate the use of RRF funds by Participating States that are Member States. The RRF funds can complement the actions funded by the Joint Undertaking, provided that support under the RRF is additional to the support provided by the Union funds of the Joint Undertaking and that it does not cover the same cost. The use of RRF should not be accounted as national contribution to the budget of the Joint Undertaking, particularly in regard to High Performance Computing and quantum computing service and data infrastructures, as well as on technology, applications and skills development projects. (42) The Union\u2019s contribution from the Digital Europe Programme funds should partly cover the acquisition costs of high-end supercomputers, quantum computers, industrial-grade supercomputers and mid-range supercomputers to align with the Joint Undertaking\u2019s objective to contribute to the pooling of resources for equipping the Union with top-class supercomputers and quantum computers. The complementary costs of these supercomputers and quantum computers should be covered by the Participating States, the Private Members or consortia of private partners. The share of the Union\u2019s access time to these supercomputers or quantum computers should be directly proportional to the financial contribution of the Union made for the acquisition of these supercomputers and quantum computers and should not exceed 50 % of the total access time of these supercomputers or quantum computers. (43) The Joint Undertaking should be the owner of the high-end supercomputers and quantum computers it has acquired. The operation of each high-end supercomputer or quantum computer should be entrusted to a hosting entity. The hosting entity should be able to represent a single Participating State that is a Member State or a hosting consortium of Participating States. The hosting entity should be able to provide an accurate estimate and to verify the operating costs of the supercomputer, by ensuring, for example, the functional separation, and to the extent possible, the physical separation of the Joint Undertaking\u2019s high-end supercomputers or quantum computers and any national or regional computing systems it operates. The hosting entity should be selected by the Governing Board of the Joint Undertaking (the \u2018Governing Board\u2019) following a call for expression of interest evaluated by independent experts. Once a hosting entity is selected, the Participating State where the hosting entity is established or the hosting consortium should be able to decide to call for other Participating States to join and contribute to the funding of the high-end supercomputer or quantum computer to be installed in the selected hosting entity. If additional Participating States join the selected hosting consortium, this should be without prejudice to the Union\u2019s access time to the supercomputers. The contributions of the Participating States in a hosting consortium to the supercomputer or quantum computer should be translated into shares of access time to that supercomputer or quantum computer. The Participating States should agree among themselves the distribution of their share of access time to the supercomputer or the quantum computer. (44) The Joint Undertaking should remain the owner of supercomputers or quantum computers it acquires until they are depreciated. The Joint Undertaking should be able to transfer this ownership to the hosting entity for decommissioning, disposal or any other use. When the ownership is transferred to the hosting entity or when the Joint Undertaking is being wound up, the hosting entity should reimburse the Joint Undertaking the residual value of the supercomputer or the quantum computer. (45) The Joint Undertaking should jointly with Participating States acquire the mid-range supercomputers. The operation of each mid-range supercomputer should be entrusted to a hosting entity. The hosting entity should be able to represent a single Participating State that is a Member State or a hosting consortium of Participating States. The Joint Undertaking should own the part that corresponds to the Union\u2019s share of the financial contribution to the acquisition costs from Digital Europe Programme funds. The hosting entity should be selected by the Governing Board following a call for expression of interest evaluated by independent experts. The share of the Union\u2019s access time to each mid-range supercomputer should be directly proportional to the financial contribution of the Union from Digital Europe Programme funds to the acquisition costs of that mid-range supercomputer. The Joint Undertaking should be able to transfer its ownership to the hosting entity at the earliest five years after the successful acceptance test by the Joint Undertaking or when it is being wound up. The hosting entity should reimburse the Joint Undertaking the residual value of the supercomputer. (46) To promote an equitable and balanced distribution across the Union of EuroHPC supercomputers and the emergence of a federated infrastructure ecosystem approach, the calls for expression of interest of a EuroHPC supercomputer should define the eligibility conditions that should apply to a Participating State which is already hosting a EuroHPC supercomputer. (47) The Joint Undertaking should be able to acquire together with a consortium of private partners industrial-grade supercomputers. The operation of each such supercomputer should be entrusted to an existing hosting entity. The hosting entity should be able to associate itself with the consortium of private partners for the acquisition and operation of such a supercomputer. The Joint Undertaking should own the part that corresponds to the Union\u2019s share of financial contribution to the acquisition costs from the Digital Europe Programme funds. The hosting entity and its associated consortium of private partners should be selected by the Governing Board following a call for expression of interest evaluated by independent experts. The share of the Union\u2019s access time to such supercomputer should be directly proportional to the financial contribution of the Union from the Digital Europe Programme funds to the acquisition costs of that industrial-grade supercomputer. The Joint Undertaking should be able to reach an agreement with the consortium of private partners to sell such a supercomputer to another entity or decommission it. Alternatively, the Joint Undertaking should be able to transfer the ownership of such a supercomputer to the consortium of private partners. In that case or when the Joint Undertaking is being wound-up, the consortium of private partners should reimburse the Joint Undertaking the residual value of the Union\u2019s share of the supercomputer. In the case that the Joint Undertaking and the consortium of private partners decide to proceed to the decommissioning of the supercomputer after the full depreciation of its operation, such costs should be covered by the consortium of private partners. (48) For industrial-grade supercomputers the Joint Undertaking should take into account the specific needs of industrial users, for example access procedures, quality and type of services, protection of data, protection of industrial innovation, and intellectual property, usability, trust, and other confidentiality and security requirements. (49) The design and operation of the supercomputers supported by the Joint Undertaking should take into consideration energy efficiency and environmental sustainability, using for example low-power technology, dynamic power-saving and re-use techniques like advanced cooling and heat recycling. (50) The use of the supercomputers of the Joint Undertaking should focus on civilian applications for public and private users residing, established or located in a Member State or in a third country associated to the Digital Europe Programme or to Horizon Europe, including applications in cybersecurity that may be of dual use. Users should be granted the Union\u2019s share of access time according to access policy rules defined by the Governing Board. The use of these supercomputers should also respect international agreements concluded by the Union. (51) User allocation of access time to the supercomputers of the Joint Undertaking should be free of charge for public users. It should also be free of charge for private users for their applications related to research and innovation activities funded by Horizon Europe or the Digital Europe Programme, as well as for private innovation activities of SMEs, where appropriate. Such allocation of access time should primarily be based on open calls for expression of interest launched by the Joint Undertaking and evaluated by independent experts. With the exception of SME users undertaking private innovation activities, all users benefiting from free-of-charge access time to the supercomputers of the Joint Undertaking should adopt an open science approach and disseminate knowledge gained through that access, in accordance with Regulation (EU) 2021/695. User allocation of access time for economic activities other than private innovation activities of SMEs, which face particular market failures, should be granted on a pay-per-use basis, based on market prices. Allocation of access time for such economic activities should be allowed but limited and the level of the fee to be paid should be established by the Governing Board. The access rights should be allocated in a transparent manner. The Governing Board should define specific rules to grant access time free of charge, where appropriate, and without a call for expression of interest to initiatives that are considered strategic for the Union. Representative examples of strategic initiatives of the Union include: Destination Earth, the Human Brain Project Flagship, the \u20181+ Million Genomes\u2019 initiative, the common European data spaces operating in domains of public interest, and in particular the health data space, the Centres of Excellence in High Performance Computing, national High Performance Computing Competence Centres and the Digital Innovation Hubs. Upon the Union\u2019s request, the Joint Undertaking should grant direct access time on a temporary or permanent basis to strategic initiatives and existing or future application platforms that it considers essential for providing health-related or other crucial emergency support services for the public good, to emergency and crisis management situations or to cases that the Union considers essential for its security and defence. The Joint Undertaking should be allowed to carry out some limited economic activities for commercial purposes. Access should be granted to users residing, established or located in a Member State or a third country associated to the Digital Europe Programme or to Horizon Europe. The access rights should be equitable to any user and allocated in a transparent manner. The Governing Board should define and monitor the access rights to the Union\u2019s share of access time for each supercomputer. (52) Access to the Union\u2019s share of access time of the precursors to exascale and petascale supercomputers acquired by the EuroHPC Joint Undertaking established under Regulation (EU) 2018/1488 should continue to be granted to users established in the Union or a third country associated to Horizon 2020. (53) The supercomputers of the Joint Undertaking should be operated and used in compliance with Regulation (EU) 2016/679 of the European Parliament and of the Council (8) and Directives 2002/58/EC (9) and (EU) 2016/943 (10) of the European Parliament and of the Council. (54) Governance of the Joint Undertaking should be assured by two bodies: a Governing Board, and an Industrial and Scientific Advisory Board. The Governing Board should be composed of representatives of the Union and of Participating States. The Governing Board should be responsible for strategic policy-making and funding decisions related to the activities of the Joint Undertaking, including all the public procurement activities. The Industrial and Scientific Advisory Board should include representatives of academia and industry as users and technology suppliers. It should provide independent advice to the Governing Board on the Strategic Research and Innovation Agenda, on the acquisition and operation of the supercomputers owned by the Joint Undertaking, the capability building and widening activities programme and the federation, connectivity and international cooperation activities programme. (55) For the general administrative tasks of the Joint Undertaking, the voting rights of the Participating States should be distributed equally among them. For the tasks corresponding to the setting up of the part of the work programme related to the acquisition of the supercomputers and quantum computers, the selection of the hosting entity, the federation and connectivity activities and the research and innovation activities of the Joint Undertaking, the voting rights of the Participating States that are Member States should be based on the principle of qualified majority. The Participating States that are third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility should also hold voting rights for the respective activities that are supported with budgetary envelopes from each of those programmes. For the tasks corresponding to the acquisition and operation of the supercomputers and quantum computers, only those Participating States and the Union that contribute resources to those tasks should have voting rights. (56) The Union\u2019s financial contribution should be managed in accordance with the principle of sound financial management and with the relevant rules on indirect management set out in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (11). The rules applicable for the Joint Undertaking to enter into public procurement procedures should be set out in its financial rules. (57) To foster an innovative and competitive European High Performance Computing and quantum computing ecosystem of recognised excellence across Europe, the Joint Undertaking should make appropriate use of the procurement and grant instruments, including joint procurement, pre-commercial procurement and public procurement of innovative solutions. This aims at creating links between technologies primarily developed in the Union, co-design with users and the acquisition of first-of-a-kind world-class supercomputing and quantum computing systems. (58) In assessing the overall impact of the Joint Undertaking, investments in indirect actions from the Private Members should be taken into account as in-kind contributions consisting of the eligible costs incurred by them in implementing actions, less the contributions by the Joint Undertaking, the Participating States or any other Union contribution to those costs. In assessing the overall impact of the Joint Undertaking, investments in other actions from the Private Members should be taken into account as in-kind contributions consisting of the eligible costs incurred by them in implementing the actions, less the contributions by the Joint Undertaking, the Participating States or any other Union contribution to those costs. (59) In order to maintain a level playing field for all undertakings active in the internal market, funding from the Union programmes should be consistent with State aid principles so as to ensure the effectiveness of public spending and prevent market distortions such as crowding out of private funding, the creation of ineffective market structures, the preservation of inefficient firms or the creation of a subsidies-reliant culture. (60) Participation in indirect actions funded by the Joint Undertaking should comply with Regulation (EU) 2021/695. The Joint Undertaking should, moreover, ensure the consistent application of those rules based on relevant measures adopted by the Commission. In order to ensure appropriate co-financing of indirect actions by the Participating States, in compliance with Regulation (EU) 2021/695, the Participating States should contribute an amount at least equal to the reimbursement provided by the Joint Undertaking for the eligible costs incurred by beneficiaries in implementing the actions. To that effect, the maximum funding rates set out in the annual work programme of the Joint Undertaking should be fixed by the Governing Board in accordance with Article 34 of Regulation (EU) 2021/695. (61) In order to ensure the right balance of stakeholders\u2019 participation in the actions funded by the Joint Undertaking, a derogation from Article 34 of Regulation (EU) 2021/695 is necessary to allow a differentiation of reimbursement rates depending on the type of participant, namely SMEs, and the type of action, to be applied invariably across beneficiaries from all Participating States. For activities funded under the Digital Europe Programme, the Joint Undertaking should allow reimbursement rates depending on the type of participant, namely SMEs, and the type of action, to be applied invariably across beneficiaries from all Participating States. (62) Provision of financial support to activities from the Digital Europe Programme should comply with Regulation (EU) 2021/694. In particular, in relation to classified information, actions funded under the Digital Europe Programme should comply with Article 12(1) of that Regulation. (63) Provision of financial support to activities from the Connecting Europe Facility should comply with Regulation (EU) 2021/1153. (64) Beneficiaries from third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility that are Participating States should be eligible for participation in actions only where a Participating State is a third country associated to one or more programmes related to that action. (65) The financial interests of the Union and of the other members of the Joint Undertaking should be protected by proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of lost, wrongly paid or incorrectly used funds and, where appropriate, the application of administrative and financial penalties in accordance with Regulation (EU, Euratom) 2018/1046. (66) The Joint Undertaking should operate in an open and transparent way providing all relevant information in a timely manner as well as promoting its activities, including information and dissemination activities, to the wider public. The rules of procedure of the bodies of the Joint Undertaking should be made publicly available. (67) For the purpose of simplification, the administrative burden should be reduced for all parties. Double audits and disproportionate amounts of documentation and reporting should be avoided. (68) The Commission\u2019s internal auditor should exercise the same powers over the Joint Undertaking as those exercised in respect of the Commission. (69) The Commission, the Joint Undertaking, the Court of Auditors and the European Anti-Fraud Office (OLAF) and the European Public Prosecutor\u2019s Office (EPPO) should have access to all necessary information and the premises to conduct audits and investigations on the grants, contracts and agreements signed by the Joint Undertaking. (70) All calls for proposals and all calls for tenders under this Regulation should take into account the duration of Horizon Europe, of the Digital Europe Programme and of the Connecting Europe Facility, as appropriate, except in duly justified cases. Procurement procedures for the acquisition of the supercomputers and quantum computers of the Joint Undertaking should be in accordance with the applicable provisions of the Digital Europe Programme. In duly justified cases related to availability of remaining budget stemming from the MFF 2021-2027, the Joint Undertaking should be able to launch calls for proposals or calls for tenders by 31 December 2028. (71) An interim and a final evaluation of the Joint Undertaking should be conducted by the Commission with the assistance of independent experts. In a spirit of transparency, the relevant independent experts\u2019 report should be made publicly available, in compliance with the applicable rules. (72) Since the objectives of this Regulation, namely the strengthening of research and innovation capabilities, the development of supercomputing capability building and widening activities, the federation, connectivity and international cooperation and the acquisition of world-class supercomputers, and access to High Performance Computing, quantum computing service and data infrastructure across the Union by means of a Joint Undertaking, cannot be sufficiently achieved by the Member States, but can rather, by reason of avoiding unnecessary duplication, retaining critical mass and ensuring that public financing is used in an optimal way, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAS ADOPTED THIS REGULATION: Article 1 Establishment 1. For the implementation of the initiative on European High Performance Computing, a Joint Undertaking within the meaning of Article 187 of the Treaty on the Functioning of the European Union (TFEU) (the \u2018European High Performance Computing Joint Undertaking\u2019, the \u2018Joint Undertaking\u2019) is hereby established for a period until 31 December 2033. 2. In order to take into account the duration of the MFF 2021-2027 and of Horizon Europe, the Digital Europe Programme and the Connecting Europe Facility, calls for proposals and calls for tenders under this Regulation shall be launched by 31 December 2027. In duly justified cases, calls for proposals or calls for tenders may be launched by 31 December 2028. 3. The Joint Undertaking shall have legal personality. In each Member State, it shall enjoy the most extensive legal capacity accorded to legal persons under the laws of that Member State. It may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings. 4. The seat of the Joint Undertaking shall be located in Luxembourg. 5. The Statutes of the Joint Undertaking (\u2018the Statutes\u2019) are set out in the Annex. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018acceptance test\u2019 means a test conducted to determine if the requirements of the system specification are met by a EuroHPC supercomputer; (2) \u2018access time\u2019 means the computing time of a supercomputer that is made available to a user or a group of users to execute their computer programmes; (3) \u2018affiliated entity\u2019 means any legal entity as defined in Article 187(1) of Regulation (EU, Euratom) 2018/1046; (4) \u2018Centre of Excellence in High Performance Computing\u2019 means a collaborative project selected in an open and competitive call for proposals to promote the use of upcoming extreme performance computing capabilities enabling user communities in collaboration with other High Performance Computing stakeholders to scale up existing parallel codes towards exascale and extreme scaling performance; (5) \u2018co-design\u2019 means a collective approach between technology suppliers and users engaged in a collaborative and iterative design process for developing new technologies, applications and systems; (6) \u2018conflict of interest\u2019 means a situation involving a financial actor or other person as referred to in Article 61 of Regulation (EU, Euratom) 2018/1046; (7) \u2018constituent entity\u2019 means an entity that constitutes a Private Member of the Joint Undertaking, pursuant to the statutes of each Private Member; (8) \u2018consortium of private partners\u2019 means an association of Union legal entities coming together for the purpose of acquiring jointly with the Joint Undertaking an industrial-grade supercomputer; one or more of these private partners may be participating in the Private Members of the Joint Undertaking; (9) \u2018EuroHPC supercomputer\u2019 means any computing system fully owned by the Joint Undertaking or co-owned with other Participating States or a consortium of private partners; it can be a classical supercomputer (high-end supercomputer, industrial-grade supercomputer, or mid-range supercomputer), a hybrid classical-quantum computer, a quantum computer or a quantum simulator; (10) \u2018exascale\u2019 means a performance level capable of executing ten to the power of eighteen operations per second (or 1 Exaflop); (11) \u2018high-end supercomputer\u2019 means a world-class computing system developed with the most advanced technology available at a given point in time and achieving at least exascale levels of performance or beyond (i.e. post-exascale) for applications addressing problems of greater complexity; (12) \u2018hosting consortium\u2019 means a group of Participating States or a consortium of private partners that have agreed to contribute to the acquisition and operation of a EuroHPC supercomputer, including any organisations representing these Participating States; (13) \u2018hosting entity\u2019 means a legal entity which includes facilities to host and operate a EuroHPC supercomputer and which is established in a Participating State that is a Member State; (14) \u2018hyper-connected\u2019 means a communication capability of transferring data at 10 to the power of twelve bits per second (1 Terabit per second) or beyond; (15) \u2018industrial-grade supercomputer\u2019 means at least a mid-range supercomputer specifically designed with security, confidentiality and data integrity requirements for industrial users that are more demanding than for a scientific use; (16) \u2018in-kind contributions to indirect actions\u2019 funded from Horizon Europe means contributions by the Participating State or the Private Members of the Joint Undertaking or their constituent entities or their affiliated entities, consisting of the eligible costs incurred by them in implementing indirect actions less the contribution of that Joint Undertaking, of the Participating States of that Joint Undertaking and of any other Union contribution to those costs; (17) \u2018in-kind contributions to actions\u2019 funded from the Digital Europe Programme or the Connecting Europe Facility means contributions by the Participating State or the Private Members of the Joint Undertaking or their constituent entities or their affiliated entities, consisting of the eligible costs incurred by them in implementing part of the activities of the Joint Undertaking less the contribution of that Joint Undertaking, of the Participating States of that Joint Undertaking and of any other Union contribution to those costs; (18) \u2018mid-range supercomputer\u2019 means a world-class supercomputer with at most one order of magnitude lower performance level than a high-end supercomputer; (19) \u2018national High Performance Computing Competence Centre\u2019 means a legal entity, or a consortium of legal entities, established in a Participating State, associated with a national supercomputing centre of that Participating State, providing users from industry, including SMEs, academia, and public administrations with access on demand to the supercomputers and to the latest High Performance Computing technologies, tools, applications and services, and offering expertise, skills, training, networking and outreach; (20) \u2018observer State\u2019 means a country eligible to participate in the actions of the Joint Undertaking funded by Horizon Europe or the Digital Europe Programme that is not a Participating State; (21) \u2018Participating State\u2019 means a country that is a member of the Joint Undertaking; (22) \u2018performance level\u2019 means the number of floating point operations per second (flops) that a supercomputer can execute; (23) \u2018Private Member\u2019 means any member of the Joint Undertaking other than the Union or Participating States; (24) \u2018quantum computer\u2019 means a computing device that harnesses the laws of quantum mechanics to solve certain particular tasks using therefore fewer computational resources than classical computers; (25) \u2018quantum simulator\u2019 means a highly controllable quantum device that allows to obtain insights into properties of complex quantum systems or to solve specific computational problems inaccessible to classical computers; (26) \u2018security of the supply chain\u2019 of a EuroHPC supercomputer means the measures to include in the selection of any supplier of this supercomputer to ensure the availability of components, technologies, systems and knowhow required in the acquisition and operation of this supercomputer; this includes measures for mitigating the risks related to eventual disruptions in the supply of such components, technologies, and systems, including price changes or lower performance or alternative sources of supply; it covers the whole lifetime of the EuroHPC supercomputer; (27) \u2018Strategic Research and Innovation Agenda\u2019 means the document covering the duration of Horizon Europe that identifies the key priorities and the essential technologies and innovations required to achieve the objectives of the Joint Undertaking; (28) \u2018multiannual strategic programme\u2019 means a document laying out a strategy for all the activities of the Joint Undertaking; (29) \u2018supercomputing\u2019 means computing at performance levels requiring the massive integration of individual computing elements, including quantum components, for solving problems which cannot be handled by standard computing systems; (30) \u2018total cost of ownership\u2019 of a EuroHPC supercomputer means the acquisition costs plus the operating costs, including maintenance, until the ownership of the supercomputer is transferred to the hosting entity or is sold, or until the supercomputer is decommissioned without transfer of ownership; (31) \u2018work programme\u2019 means the document referred to in Article 2, point (25), of Regulation (EU) 2021/695 or, where relevant, the document which also functions as the work programme referred to in Article 24 of Regulation (EU) 2021/694, or Article 19 of Regulation (EU) 2021/1153. Article 3 Mission and objectives 1. The mission of the Joint Undertaking shall be: to develop, deploy, extend and maintain in the Union a world-leading federated, secure and hyper-connected supercomputing, quantum computing, service and data infrastructure ecosystem; to support the development and uptake of demand-oriented and user-driven innovative and competitive supercomputing systems based on a supply chain that will ensure components, technologies and knowledge limiting the risk of disruptions and the development of a wide range of applications optimised for these systems; and, to widen the use of that supercomputing infrastructure to a large number of public and private users, and support the twin transition and the development of key skills for European science and industry. 2. The Joint Undertaking shall have the following overall objectives: (a) to contribute to the implementation of Regulation (EU) 2021/695 and in particular Article 3 thereof, to deliver scientific, economic, environmental, technological and societal impact from the Union\u2019s investments in research and innovation, so as to strengthen the scientific and technological bases of the Union, deliver on the Union strategic priorities and contribute to the realisation of Union objectives and policies, and to contribute to tackling global challenges, including the Sustainable Development Goals by following the principles of the United Nations Agenda 2030 and the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (12); (b) to develop close cooperation and ensure coordination with other European Partnerships, including through joint calls, as well as to seek synergies with relevant activities and programmes at Union, national, and regional level, in particular with those supporting the deployment of innovative solutions, education and regional development, where relevant; (c) to develop, deploy, extend and maintain in the Union an integrated, demand-oriented and user-driven hyper-connected world-class supercomputing and data infrastructure; (d) to federate the hyper-connected supercomputing and data infrastructure and interconnect it with the European data spaces and cloud ecosystem for providing computing and data services to a wide range of public and private users in Europe; (e) to promote scientific excellence and support the uptake and systematic use of research and innovation results generated in the Union; (f) to further develop and support a highly competitive and innovative supercomputing and data ecosystem broadly distributed in Europe contributing to the scientific and digital leadership of the Union, capable of autonomously producing computing technologies and architectures and their integration on leading computing systems, and advanced applications optimised for these systems; (g) to widen the use of supercomputing services and the development of key skills that European science and industry need. 3. The Joint Undertaking shall contribute to safeguarding the interests of the Union when procuring supercomputers and supporting the development and uptake of High Performance Computing technologies, systems and applications. It shall enable a co-design approach for the acquisition of world-class supercomputers, while safeguarding the security of the supply chain of procured technologies and systems. It shall contribute to the Union\u2019s strategic autonomy, support the development of technologies and applications reinforcing the European High Performance Computing supply chain and promote their integration in supercomputing systems that address a large number of scientific, societal, environmental and industrial needs. Article 4 Pillars of activity 1. The Joint Undertaking shall implement the mission referred to in Article 3 according to the following pillars of activities: (a) administration pillar, covering the general activities for the operation and management of the Joint Undertaking; (b) infrastructure pillar, encompassing the activities for the acquisition, deployment, upgrading and operation of the secure, hyper-connected world-class supercomputing, quantum computing and data infrastructure, including the promotion of the uptake and systematic use of research and innovation results generated in the Union; (c) federation of supercomputing services pillar, covering all activities for providing Union-wide access to federated, secure supercomputing and data resources and services throughout Europe for the research and scientific community, industry, including SMEs, and the public sector, in particular in cooperation with PRACE and G\u00c9ANT; those activities shall include: (i) support to the interconnection of the High Performance Computing, quantum computing and data resources owned fully or partially by the Joint Undertaking or made available on a voluntary basis by the Participating States; (ii) support to the interconnection of the supercomputing, and quantum computing data infrastructures with the Union\u2019s common European data spaces and federated, secure cloud and data infrastructures; (iii) support to the development, acquisition and operation of a platform for the seamless federation and secure service provisioning of supercomputing and quantum computing service and data infrastructure, establishing a one-stop shop access point for any supercomputing or data service managed by the Joint Undertaking, providing any user with a single point of entry; (d) technology pillar, addressing ambitious research and innovation activities for developing a world-class, competitive and innovative supercomputing ecosystem across Europe addressing hardware and software technologies, and their integration into computing systems, covering the whole scientific and industrial value chain, for contributing to the Union\u2019s strategic autonomy; it shall also focus on energy-efficient High Performance Computing technologies, contributing to environmental sustainability; those activities shall address inter alia: (i) low-power micro-processing components, interconnection components, system architecture and related technologies such as novel algorithms, software codes, tools, and environments; (ii) emerging computing paradigms and their integration into leading supercomputing systems through a co-design approach; these technologies shall be linked with the development, acquisition and deployment of high-end supercomputers, including quantum computers, and infrastructures; (iii) technologies and systems for the interconnection and operation of classical supercomputing systems with other, often complementary computing technologies, such as quantum computing or other emerging computing technologies and ensure their effective operation; (iv) new algorithms and software technologies that offer substantial performance increases; (e) application pillar, addressing activities for achieving and maintaining European excellence in key computing and data applications and codes for science, industry, including SMEs, and the public sector; those activities shall address inter alia: (i) applications, including new algorithms and software developments, for public and private users that benefit from the exploitation of the resources and capabilities of high-end supercomputers and their convergence with advanced digital technologies such as artificial intelligence, high performance data analytics, cloud technologies, etc. through the co-design, development and optimisation of High Performance Computing-enabled large-scale and emerging lead-market codes and applications; (ii) support, among others, to Centres of Excellence in High Performance Computing in applications and large-scale High Performance Computing-enabled pilot demonstrators and test-beds for big data applications and advanced digital services in a wide range of scientific, public and industrial sectors; (f) widening usage and skills pillar, aiming at developing capabilities and skills that foster excellence in supercomputing, quantum computing, and data use, taking into account synergies with other programmes and instruments, in particular Digital Europe Programme, widening the scientific and industrial use of supercomputing resources and data applications and fostering the industrial access and use of supercomputing and data infrastructures for innovation adapted to industrial needs, as well as providing Europe with a knowledgeable leading scientific community and a skilled workforce for scientific leadership and digital transformation of industry and public administration, including the support and networking of national High Performance Computing Competence Centres and Centres of Excellence in High Performance Computing; (g) international cooperation pillar, in line with the external policy objectives and international commitments of the Union, defining, implementing and participating in activities relevant to the promotion of international collaboration in supercomputing to solve global scientific and societal challenges, while promoting competitiveness of the European High Performance Computing supply and user ecosystem. 2. In addition to the activities referred to in paragraph 1, the Joint Undertaking may be entrusted with the implementation of additional tasks in the event of cumulative, complementary or combined funding between Union programmes in accordance with the relevant Commission work programme. Article 5 Union\u2019s financial contribution 1. The Union financial contribution to the Joint Undertaking including EEA appropriations shall be up to EUR 3 081 300 000, including EUR 92 000 000 for administrative costs, on the condition that that amount is at least matched by the contribution of Participating States, distributed as follows: (a) up to EUR 900 000 000 from Horizon Europe; (b) up to EUR 1 981 300 000 from the Digital Europe Programme; (c) up to EUR 200 000 000 from the Connecting Europe Facility. 2. The Union financial contribution referred to in paragraph 1 shall be paid from the appropriations in the general budget of the Union allocated to each relevant programme. 3. Additional Union funds complementing the contribution referred to in paragraph 1 of this Article may be allocated to the Joint Undertaking to support its pillars of activities referred to in Article 4, except those referred to in Article 4(1)(a). 4. Contributions from Union programmes corresponding to additional activities entrusted to the Joint Undertaking in accordance with paragraph 3 shall not be accounted for in the calculation of the Union maximum financial contribution. 5. Additional Union funds complementing the contribution referred to in paragraph 1 of this Article may be allocated to the Joint Undertaking from third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility in accordance with their respective association agreements. Those additional Union funds shall not affect the Participating States\u2019 contribution referred to in Article 7(1), unless the Participating States agree otherwise. 6. The Union financial contribution referred to in paragraph 1(a) of this Article shall be used for the Joint Undertaking to provide financial support to indirect actions as defined in Article 2, point (43), of Regulation (EU) 2021/695, corresponding to the research and innovation activities of the Joint Undertaking. 7. The Union financial contribution referred to in paragraph 1(b) shall be used for capability building across the whole Union, including the acquisition, upgrade and operation of High Performance Computers, quantum computers or quantum simulators, the federation of the High Performance Computing and quantum computing service and data infrastructure and the widening of its use, and the development of advanced skills and training. 8. The Union financial contribution referred to in paragraph 1(c) shall be used for the interconnection of the High Performance Computing and data resources and the creation of an integrated pan-European hyper-connected High Performance Computing and data infrastructure. Article 6 Other Union contributions Contributions from Union programmes other than those referred to in Article 5(1) that are part of a Union co-financing to a programme implemented by one of the Participating States that is a Member State shall not be accounted for in the calculation of the Union maximum financial contribution referred to in Article 5. Article 7 Contributions of members other than the Union 1. The Participating States shall make a total contribution that is commensurate to the Union\u2019s contribution referred to in Article 5(1). The Participating States shall arrange among them their collective contributions and how they will deliver them. This shall not affect the ability of each Participating State to define its national financial contribution in accordance with Article 8. 2. The Private Members of the Joint Undertaking shall make or arrange for their constituent entities and affiliated entities to make contributions for at least EUR 900 000 000 to the Joint Undertaking. 3. The contributions referred to in paragraphs 1 and 2 of this Article shall consist of contributions as set out in Article 15 of the Statutes. 4. The contributions referred to in Article 15(3)(f) of the Statutes may be provided by each Participating State to beneficiaries established in that Participating State. Participating States may complement the Joint Undertaking\u2019s contribution, within the applicable maximum reimbursement rate set out in Article 34 of Regulation (EU) 2021/695, Article 14 of Regulation (EU) 2021/694 and in Article 14 of Regulation (EU) 2021/1153. Such contributions shall be without prejudice to State aid rules. 5. The members of the Joint Undertaking other than the Union shall report by 31 January of each year to the Governing Board as defined in Article 15 of the Statutes, on the value of the contributions referred to in paragraphs 1 and 2 of this Article made in the previous financial year. 6. For the purpose of valuing the contributions referred to in points Article 15(3)(b) to (f) of the Statutes, the costs shall be determined in accordance with the usual cost accounting practices of the entities concerned, with the applicable accounting standards of the country where the entity is established and with the applicable International Accounting Standards and International Financial Reporting Standards. The costs shall be certified by an independent external auditor appointed by the entity concerned or by the audit authorities of the Participating States. The valuation method may be verified by the Joint Undertaking, should there be any uncertainty arising from the certification. If there are remaining uncertainties, the valuation method may be audited by the Joint Undertaking. 7. The Commission may terminate, proportionally reduce or suspend the Union financial contribution to the Joint Undertaking or trigger the winding up procedure referred to in Article 23 of the Statutes in the following cases: (a) if the Joint Undertaking fails to meet the conditions for the Union contribution; or (b) if the members other than the Union or their constituent entities or their affiliated entities fail to contribute, contribute only partially or do not respect the time frames with regard to the contribution referred to in paragraphs 1 and 2 of this Article; or (c) as a result of the evaluations referred to in Article 24. The Commission\u2019s decision to terminate, proportionally reduce or suspend the Union financial contribution shall not hinder the reimbursement of eligible costs incurred by the members other than the Union before the decision is notified to the Joint Undertaking. Article 8 Management of contributions from the Participating States 1. Each Participating State shall make an indicative commitment of the amount of their national financial contributions in indirect actions to the Joint Undertaking. Such a commitment shall be made annually to the Joint Undertaking prior to the adoption of the work programme. In addition to the criteria set out in Article 22 of Regulation (EU) 2021/695, in Article 18 of Regulation (EU) 2021/694 or in Article 11 of Regulation (EU) 2021/1153, the work programme may include, as an annex, eligibility criteria regarding the participation of national legal entities. Each Participating State shall entrust the Joint Undertaking with the evaluation of the proposals in accordance with Horizon Europe rules. The selection of proposals shall be based on the ranking list provided by the evaluation committee. The Governing Board may deviate from that list in duly justified cases as set out in the work programme to ensure the overall consistency of the portfolio approach. Each Participating State shall have a right of veto on all issues concerning the use of its own national financial contributions to the Joint Undertaking for applicants established in those Participating States, on the basis of national strategic priorities. 2. Each Participating State shall conclude one or more administrative agreements with the Joint Undertaking laying down the coordination mechanism for the payment of and reporting on contributions to applicants established in that Participating State. Such an agreement shall include the schedule, conditions of payment, reporting and audit requirements. Each Participating State shall strive to synchronise its payment schedule, reporting and audits, with those of the Joint Undertaking and to converge its cost eligibility rules with Horizon Europe\u2019s rules. 3. In the agreement referred to in paragraph 2, each Participating State may entrust the Joint Undertaking with the payment of its contribution to its beneficiaries. After the selection of proposals, the Participating State shall commit the amount necessary for payments. The audit authorities of the Participating State may audit their respective national contributions. Article 9 Hosting entity 1. EuroHPC supercomputers shall be located in a Participating State that is a Member State. In case a Participating State is already hosting a EuroHPC supercomputer which is a high-end or a mid-range supercomputer, it shall not be eligible to participate in a new call for expression of interest for the incremental generation of such supercomputers before at least five years from the selection date following a previous call for expression of interest. In the case of the acquisition of quantum computers and quantum simulators, or the upgrade of a EuroHPC supercomputer with quantum accelerators, that period is reduced to two years. 2. For the EuroHPC supercomputers referred to in Articles 11, 12 and 14, the hosting entity may represent a Participating State that is a Member State or a hosting consortium. The hosting entity and the competent authorities of the Participating State or Participating States in a hosting consortium shall enter into an agreement to that effect. 3. The Joint Undertaking shall entrust to a hosting entity the operation of each individual EuroHPC supercomputer fully owned by the Joint Undertaking, or jointly owned in accordance with Articles 11, 12 and 14. 4. Hosting entities referred to in paragraph 2 of this Article shall be selected in accordance with paragraph 5 of this Article and the Joint Undertaking\u2019s financial rules referred to in Article 19. 5. Following a call for expression of interest, the hosting entity referred to in paragraph 2 of this Article and the corresponding Participating State where the hosting entity is established or the corresponding hosting consortium shall be selected by the Governing Board through a fair and transparent process based, inter alia, on the following criteria: (a) compliance with the general system specifications defined in the call for expression of interest; (b) total cost of ownership of the EuroHPC supercomputer, including an accurate estimate and a verification method of the operating costs of this supercomputer during its lifetime; (c) experience of the hosting entity in installing and operating similar systems; (d) quality of the hosting facility\u2019s physical and IT infrastructure, its security and its connectivity with the rest of the Union; (e) quality of service to the users, namely capability to comply with the service level agreement provided among the documents accompanying the selection procedure; (f) provision of an appropriate supporting document proving the commitment of the Member State where the hosting entity is established or of the competent authorities of the Participating States of the hosting consortium to cover the share of the total cost of ownership of the EuroHPC supercomputer that is not covered by the Union contribution as set out in Article 5 or any other Union contribution as set out in Article 6, either until its ownership is transferred by the Joint Undertaking to that hosting entity or until the supercomputer is sold or decommissioned if there is no transfer of ownership. 6. For the industrial-grade EuroHPC supercomputers referred to in Article 13, the hosting entity shall enter into an agreement with a consortium of private partners for preparing the acquisition and for operating such supercomputers or partitions of EuroHPC supercomputers. Hosting an industrial-grade supercomputer shall respect the following conditions: (a) the Joint Undertaking shall entrust to the hosting entity the operation of each individual industrial-grade EuroHPC supercomputer jointly owned in accordance with Article 13; (b) hosting entities shall be selected in accordance with paragraph 5 of this Article and the Joint Undertaking\u2019s financial rules referred to in Article 19; (c) following a call for expression of interest, the hosting entity and its associated consortium of private partners shall be selected by the Governing Board through a fair and transparent process based, inter alia, on the following: (i) the criteria set out in paragraphs 5(a) to 5(e) of this Article; and (ii) the provision of an appropriate supporting document proving the commitment of the consortium of private partners to cover the share of the total cost of ownership of the EuroHPC supercomputer that is not covered by the Union contribution as set out in Article 5 or any other Union contribution as set out in Article 6. 7. The selected hosting entity may decide to invite, subject to the prior agreement of the Commission, additional Participating States, or a consortium of private partners, to join the hosting consortium. The financial or in-kind contribution or any other commitment of the joining Participating States, or Private Members, shall not affect the Union financial contribution and the corresponding ownership rights and percentage of access time allocated to the Union with regard to that EuroHPC supercomputer as defined in Articles 11, 12, 13, and 14. Article 10 Hosting agreement 1. The Joint Undertaking shall conclude a hosting agreement with each selected hosting entity prior to launching the procedure for the acquisition of a EuroHPC supercomputer. 2. The hosting agreement shall address in particular the following elements regarding the EuroHPC supercomputers: (a) the rights and obligations during the procedure for acquisition of the supercomputer, including the acceptance tests of the supercomputer; (b) the liability conditions for operating the supercomputer; (c) the quality of service offered to the users when operating the supercomputer, as set out in the service level agreement; (d) the plans regarding the supercomputer\u2019s energy efficiency and environmental sustainability; (e) the access conditions of the Union\u2019s share of access time to the supercomputer, as decided by the Governing Board in accordance with Article 17; (f) the accounting modalities of the access times; (g) the share of the total cost of ownership that the hosting entity shall arrange to be covered by the Participating State where the hosting entity is established or by the Participating States in the hosting consortium; (h) the conditions for the transfer of ownership referred to in Articles 11(5), 12(7), 13(6) and 14(6), including, in the case of EuroHPC supercomputers, provisions for the calculation of their residual value and for their decommissioning; (i) the obligation of the hosting entity to provide access to the EuroHPC supercomputers, while ensuring the security of the supercomputers, the protection of personal data in accordance with Regulation (EU) 2016/679, the protection of privacy of electronic communications in accordance with Directive 2002/58/EC, the protection of trade secrets in accordance with Directive (EU) 2016/943 and the protection of confidentiality of other data covered by the obligation of professional secrecy; (j) the obligation of the hosting entity to put in place a certified audit procedure covering the costs of operation of the EuroHPC supercomputer and the access times of the users; (k) the obligation of the hosting entity to submit by 31 January of each year to the Governing Board an audit report and data on the use of access time in the previous financial year; (l) the specific conditions applicable when the hosting entity operates a EuroHPC supercomputer for industrial usage. 3. The hosting agreement shall be governed by Union law, supplemented, for any matter not covered by this Regulation or by other Union legal acts, by the law of the Member State where the hosting entity is established. 4. The hosting agreement shall contain an arbitration clause, within the meaning of Article 272 TFEU, granting jurisdiction over all matters covered by the hosting agreement to the Court of Justice of the European Union. 5. After the hosting agreement is concluded, and without prejudice to paragraph 2 of this Article, the Joint Undertaking, supported by the selected hosting entity, shall launch the procedures for the acquisition of the EuroHPC supercomputer in accordance with the financial rules of the Joint Undertaking referred to in Article 19. 6. For mid-range supercomputers, after the hosting agreement is concluded, the Joint Undertaking, or the hosting entity shall launch on behalf of both contracting parties the procedures for the acquisition of the EuroHPC supercomputer in accordance with the financial rules of the Joint Undertaking referred to in Article 19. Article 11 Acquisition and ownership of high-end supercomputers 1. The Joint Undertaking shall acquire the high-end supercomputers and shall own them. 2. The Union financial contribution referred to in Article 5(1) shall cover up to 50 % of the acquisition costs plus up to 50 % of the operating costs of the high-end supercomputers. The remaining total cost of ownership of the high-end supercomputers shall be covered by the Participating State where the hosting entity is established or by the Participating States in the hosting consortium, possibly supplemented by the contributions referred to in Article 6. 3. The selection of the supplier of the high-end supercomputer shall be based on tender specifications that shall take into account the user requirements and the general system specifications provided by the selected hosting entity in its application for the call for expression of interest. The selection shall also address the security of the supply chain. 4. The Joint Undertaking may act as first user and acquire high-end supercomputers that integrate demand-oriented, user driven and competitive technologies primarily developed in the Union. 5. The Governing Board may decide in the work programme, if duly justified for security reasons, to condition the participation of suppliers in the acquisition of the high-end supercomputers in accordance with Article 12(6) of Regulation (EU) 2021/694 or to limit the participation of suppliers for security reasons or actions directly related to the Union\u2019s strategic autonomy, in accordance with Article 18(4) of that Regulation. 6. Without prejudice to the winding up of the Joint Undertaking, as referred to in Article 23(4) of the Statutes, at the earliest five years after the successful acceptance test by the Joint Undertaking of the high-end supercomputers installed in a hosting entity, the ownership of the high-end supercomputer may be transferred to the respective hosting entity, sold to another entity or decommissioned upon decision of the Governing Board and in accordance with the hosting agreement. In the case of transfer of ownership of a high-end supercomputer, the hosting entity shall reimburse the Joint Undertaking the residual value of the supercomputer that is transferred. If there is no transfer of ownership to the hosting entity but a decision for decommissioning, the relevant costs shall be shared equally by the Joint Undertaking and the hosting entity. The Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of the high-end supercomputer or after its sale or decommissioning. Article 12 Acquisition and ownership of quantum computers and quantum simulators 1. The Joint Undertaking shall acquire quantum computers and quantum simulators, that could range from pilots and experimental systems to prototypes and operational systems as stand-alone machines or hybridised with high-end or mid-range High Performance Computing machines and accessible via the cloud, and shall own them. 2. The Union financial contribution referred to in Article 5(1) shall cover up to 50 % of the acquisition costs plus up to 50 % of the operating costs of the quantum computers and quantum simulators. The remaining total cost of ownership of the quantum computers and quantum simulators shall be covered by the Participating State where the hosting entity is established or by the Participating States in the hosting consortium, possibly supplemented by the contributions referred to in Article 6. 3. The selection of the supplier of the quantum computers and quantum simulators shall be based on tender specifications that shall take into account the user requirements and the general system specifications provided by the selected hosting entity in its application for the call for expression of interest. The selection shall also address the security of the supply chain. 4. The Joint Undertaking may act as first user and acquire quantum computers and quantum simulators that integrate technologies primarily developed in the Union. 5. The Governing Board may decide in the work programme, if duly justified for security reasons, to condition the participation of suppliers in the acquisition of the quantum computers and quantum simulators in accordance with Article 12(6) of Regulation (EU) 2021/694 or to limit the participation of suppliers for security reasons or actions directly related to the Union\u2019s strategic autonomy, in accordance with Article 18(4) of that Regulation. 6. The quantum computers and quantum simulators shall be located in a hosting entity of a EuroHPC supercomputer or a supercomputing centre located in the Union. 7. Without prejudice to the winding up of the Joint Undertaking, as referred to in Article 23(4) of the Statutes, at the earliest four years after the successful acceptance test by the quantum computer or quantum simulator installed in a hosting entity, the ownership of the quantum computer or quantum simulator may be transferred to that hosting entity, sold to another entity or decommissioned upon decision of the Governing Board and in accordance with the hosting agreement. In the case of transfer of ownership of a quantum computer or quantum simulator, the hosting entity shall reimburse the Joint Undertaking the residual value of the supercomputer that is transferred. If there is no transfer of ownership to the hosting entity but a decision for decommissioning, the relevant costs shall be shared equally by the Joint Undertaking and the hosting entity. The Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of the quantum computer or quantum simulator or after its sale or decommissioning. Article 13 Acquisition and ownership of industrial-grade EuroHPC supercomputers 1. The Joint Undertaking shall acquire, together with a consortium of private partners, at least mid-range supercomputers, or partitions of EuroHPC supercomputers, primarily destined for use by industry, and shall own them or co-own them with a consortium of private partners. 2. The Union financial contribution referred to in Article 5(1) shall cover up to 35 % of the acquisition costs of the EuroHPC supercomputers, or the partitions of the EuroHPC supercomputers. The remaining total cost of ownership of the EuroHPC supercomputers, or the partitions of the EuroHPC supercomputers, shall be covered by the consortium of private partners. 3. The selection of the supplier of an industrial-grade EuroHPC supercomputer shall be based on tender specifications that shall take into account the user requirements and the general system specifications provided by the selected hosting entity in its application for the call for expression of interest. The selection shall also address the security of the supply chain. 4. The Governing Board may decide in the work programme, if duly justified for security reasons, to condition the participation of suppliers in the acquisition of the industrial grade EuroHPC supercomputers in accordance with Article 12(6) of Regulation (EU) 2021/694 or to limit the participation of suppliers for security reasons or actions directly related to the Union\u2019s strategic autonomy, in accordance with Article 18(4) of that Regulation. 5. The EuroHPC supercomputers or the EuroHPC supercomputer partitions for industrial use shall be hosted in a hosting entity of a EuroHPC supercomputer. 6. Without prejudice to the winding up of the Joint Undertaking, as referred to in Article 23(4) of the Statutes, at the earliest four years after the successful acceptance test by the Joint Undertaking of the EuroHPC supercomputers installed in a hosting entity, the ownership of the EuroHPC supercomputer may be transferred to the consortium of private partners, sold to another entity or decommissioned upon decision of the Governing Board and in accordance with the consortium of private partners. In the case of transfer of ownership of a EuroHPC supercomputer, the consortium of private partners shall reimburse the Joint Undertaking the residual value of the EuroHPC supercomputer that is transferred. If there is no transfer of ownership to the consortium of private partners but a decision for decommissioning, the relevant costs shall be covered by the consortium of private partners. The Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of the EuroHPC supercomputer or after its sale or decommissioning. Article 14 Acquisition and ownership of the mid-range supercomputers 1. The Joint Undertaking shall acquire, jointly with the contracting authorities of the Participating State where the hosting entity is established or with the contracting authorities of the Participating States in the hosting consortium, the mid-range supercomputers and shall co-own them. 2. The Union financial contribution referred to in Article 5(1) shall cover up to 35 % of the acquisition costs and up to 35 % of operating costs of the mid-range supercomputers. The remaining total cost of ownership of the mid-range supercomputers shall be covered by the Participating State where the hosting entity is established or the Participating States in the hosting consortium, possibly supplemented by the contributions referred to in Article 6. 3. The selection of the supplier of the mid-range supercomputer shall be based on tender specifications that shall take into account the user requirements and the general system specifications provided by the selected hosting entity in its application for the call for expression of interest. The selection shall also address the security of the supply chain. 4. The Joint Undertaking may act as first user and acquire mid-range supercomputers that integrate demand-oriented, user driven and competitive technologies primarily developed in the Union. 5. The Governing Board may decide in the work programme, if duly justified for security reasons, to condition the participation of suppliers in the acquisition of the mid-range supercomputers in accordance with Article 12(6) of Regulation (EU) 2021/694 or to limit the participation of suppliers for security reasons or actions directly related to the Union\u2019s strategic autonomy, in accordance with Article 18(4) of that Regulation. 6. Without prejudice to the winding up of the Joint Undertaking, as referred to in Article 23(4) of the Statutes, the part of the ownership of the supercomputer owned by the Joint Undertaking shall be transferred to the hosting entity after the full depreciation of the supercomputer. The hosting entity shall reimburse the Joint Undertaking the residual value of the supercomputer that is transferred. The Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of the mid-range supercomputer. Article 15 Upgrading of supercomputers 1. The Joint Undertaking may launch a call for expressions of interest to upgrade the EuroHPC supercomputers it owns or co-owns. The maximum EU contribution to such upgrades may not exceed EUR 150 million for the period 2021-2027. 2. A hosting entity shall be eligible to respond to this call for expressions of interest at the earliest one year after the selection date of the hosting entity of the EuroHPC supercomputer, and no later than three years after this date. A EuroHPC supercomputer may be upgraded only once. 3. The hosting entity shall be selected by the Governing Board through a fair and transparent process based, inter alia, on the following criteria: (a) justification of the upgrade; (b) compatibility with the original EuroHPC supercomputer; (c) increase in operational capacity performance of the EuroHPC supercomputer; (d) provision of an appropriate supporting document proving the commitment of the Member State where the hosting entity is established or of the competent authorities of the Participating States of the hosting consortium to cover the share of the upgrading cost of the EuroHPC supercomputer that is not covered by the Union contribution as set out in Article 5 or any other Union contribution as set out in Article 6, either until its ownership is transferred by the Joint Undertaking to that hosting entity or until the supercomputer is sold or decommissioned if there is no transfer of ownership. 4. The Joint Undertaking shall acquire, jointly with the contracting authorities of the Participating State where the selected hosting entity is established or with the contracting authorities of the Participating States in the selected hosting consortium, the upgrade of the supercomputer and shall own it under the same conditions of ownership of the original EuroHPC supercomputer. 5. The Union financial contribution for the upgrade shall cover up to 35 % of the acquisition costs of the upgrade, depreciated over the expected remaining lifetime of the original supercomputer and up to 35 % of the additional operating costs. The total cost of the upgrade shall not exceed 30 % of the total acquisition cost of the original EuroHPC supercomputer. 6. The share of the Union\u2019s access time to the upgraded EuroHPC supercomputer shall remain unchanged over the lifetime of the machine. If the upgrade entails an increase of capacity, the additional access time shall be directly proportional to the Union contribution. Article 16 Use of EuroHPC supercomputers 1. Without prejudice to Article 17(9), the use of EuroHPC supercomputers shall be open to users from the public and private sectors and shall focus on civilian applications. Except for the industrial-grade EuroHPC supercomputers, their use shall be primarily for research and innovation purposes falling under public funding programmes, for public sector applications and for private innovation activities of SMEs, where appropriate. 2. The Governing Board shall define the general access conditions for using the EuroHPC supercomputers in accordance with Article 17 and may define specific access conditions for different types of users or applications. The security and quality of service shall be the same for all users within each user category, except for the industrial-grade EuroHPC supercomputers, whose security and quality of service shall be compliant with industrial requirements, in accordance with Article 13(1). 3. Users residing, established or located in a Member State or in a third country associated to Horizon 2020 shall be granted access to the Union\u2019s share of access time of the supercomputers acquired by the EuroHPC Joint Undertaking established by Regulation (EU) 2018/1488. 4. Users residing, established or located in a Member State or in a third country associated to the Digital Europe Programme or to Horizon Europe shall be granted the Union\u2019s share of access time to EuroHPC supercomputers acquired after 2020. 5. In duly justified cases, taking into account the interests of the Union, the Governing Board shall decide to grant access time to EuroHPC supercomputers to entities residing, established or located in any third country and to international organisations. Article 17 Allocation of Union\u2019s access time to the EuroHPC supercomputers 1. The share of the Union\u2019s access time to each high-end and quantum EuroHPC supercomputer shall be directly proportional to the financial contribution of the Union referred to in Article 5(1) to the total cost of ownership of the EuroHPC supercomputer and shall thus not exceed 50 % of the total access time of the EuroHPC supercomputer. 2. The share of the Union\u2019s access time to each mid-range EuroHPC supercomputer shall be directly proportional to the financial contribution of the Union, referred to in Article 5(1), to the acquisition and operating cost of the supercomputer and shall not exceed 35 % of the total access time of the supercomputer. 3. The share of the Union\u2019s access time to each industrial-grade EuroHPC supercomputer shall be directly proportional to the financial contribution of the Union, referred to in Article 5(1), to the acquisition cost of the supercomputer and shall not exceed 35 % of the total access time of the supercomputer. 4. Each Participating State where a hosting entity is established or each Participating State in a hosting consortium shall be allocated the remaining access time to each EuroHPC supercomputer. In the case of a hosting consortium, the Participating States shall agree among themselves the distribution of access time to the supercomputer. 5. The Governing Board shall define the access rights to the Union\u2019s share of access time to the EuroHPC supercomputers. 6. Use of the Union\u2019s share of access time to the EuroHPC supercomputers shall be free of charge for the users from the public sector referred to in Article 16(4). It shall also be free of charge for industrial users for applications related to research and innovation activities funded by Horizon Europe or the Digital Europe Programme as well as those awarded a Seal of Excellence under Horizon Europe or the Digital Europe Programme and for private innovation activities of SMEs, where appropriate. As a guiding principle, allocation of access time for such activities shall be based on a fair and transparent peer review process defined by the Governing Board following continuously open calls for expression of interest launched by the Joint Undertaking. 7. With the exception of SME users undertaking private innovation activities, other users shall adopt an open science approach to disseminating knowledge gained through access to the supercomputers of the Joint Undertaking, in accordance with Article 14 of Regulation (EU) 2021/695. The Governing Board shall define further the applicable open science rules. 8. The Governing Board shall define specific rules for access conditions that depart from the guiding principles referred to in paragraph 6. These concern the allocation of access time for projects and activities considered as strategic for the Union. 9. Upon request of the Union, the Executive Director shall grant direct access to the EuroHPC supercomputers to initiatives that the Union considers essential for providing health- or climate-related or other crucial emergency support services for the public good, to emergency and crisis management situations or to cases that the Union considers essential for its security and defence. The modalities and conditions for the implementation of such access shall be defined in the access conditions adopted by the Governing Board. 10. The Governing Board shall define the conditions that apply for industrial use to provide access to the Union\u2019s share of access time to secure High Performance Computing and data resources for applications other than those specified in paragraph 6. 11. The Governing Board shall regularly monitor the Union\u2019s share of access time granted per Participating State and per user category, including for commercial purposes. It may decide among others to: (a) re-adapt access times per category of activity or user, with the aim to optimise the use capabilities of the EuroHPC supercomputers; (b) propose additional support measures for providing fair access opportunities to users that would aim to raise their level of skills and expertise in High Performance Computing systems. Article 18 Union\u2019s access time to EuroHPC supercomputers for commercial purposes 1. Specific conditions shall apply to all industry users for commercial purposes on the Union\u2019s share of access time. This service for commercial use shall be a pay-per-use service, based on market prices. The level of the fee shall be established by the Governing Board. 2. The fees generated by the commercial use of the Union\u2019s share of access time shall constitute revenue to the Joint Undertaking budget and shall be used to cover operational costs of the Joint Undertaking. 3. The access time allocated to commercial services shall not exceed 20 % of the Union\u2019s total access time of each EuroHPC supercomputer. The Governing Board shall decide on the allocation of the Union\u2019s access time for the users of commercial services, taking into account the outcome of the monitoring referred to in Article 17(11). 4. The quality of commercial services shall be the same for all users. Article 19 Financial rules 1. The Joint Undertaking shall adopt its specific financial rules in accordance with Article 71 of Regulation (EU, Euratom) 2018/1046. 2. The financial rules shall be published on the website of the Joint Undertaking. Article 20 Staff 1. The Staff Regulations of Officials of the European Union (\u2018Staff Regulations\u2019) and the Conditions of Employment of Other Servants of the European Union (\u2018Conditions of Employment\u2019), laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (13), and the rules adopted jointly by the institutions of the Union for the purpose of applying the Staff Regulations and Conditions of Employment shall apply to the staff of the Joint Undertaking. 2. The Governing Board shall exercise, with respect to the staff of the Joint Undertaking, the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment on the Authority empowered to conclude contracts (\u2018the appointing authority powers\u2019). 3. The Governing Board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment delegating the relevant appointing authority powers to the Executive Director and defining the conditions under which that delegation may be suspended. The Executive Director shall be authorised to sub-delegate those powers. 4. Where exceptional circumstances so require, the Governing Board may decide to temporarily suspend the delegation of the appointing authority powers to the Executive Director and any subsequent sub-delegation of those powers by the latter. In such cases, the Governing Board shall exercise the appointing authority powers itself or shall delegate them to one of its members or to a staff member of the Joint Undertaking other than the Executive Director. 5. The Governing Board shall adopt appropriate implementing rules giving effect to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations. 6. The staff resources shall be set out in the staff establishment plan of the Joint Undertaking, indicating the number of temporary posts by function group and by grade, as well as by the number of contract staff expressed in full-time equivalents, in accordance with its annual budget. 7. The staff of the Joint Undertaking shall consist of temporary staff and contract staff. 8. All costs related to staff shall be borne by the Joint Undertaking. Article 21 Seconded national experts and trainees 1. The Joint Undertaking may make use of seconded national experts and trainees not employed by the Joint Undertaking. The number of seconded national experts expressed in full-time equivalents shall be added to the information on staff resources as referred to in Article 20(6) in accordance with the annual budget. 2. The Governing Board shall adopt a decision laying down rules on the secondment of national experts to the Joint Undertaking and on the use of trainees. Article 22 Privileges and Immunities Protocol No 7 on the privileges and immunities of the European Union, annexed to the TEU and the TFEU, shall apply to the Joint Undertaking and its staff. Article 23 Liability of the Joint Undertaking 1. The contractual liability of the Joint Undertaking shall be governed by the relevant contractual provisions and by the law applicable to the agreement, decision or contract in question. 2. In the case of non-contractual liability, the Joint Undertaking shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its staff in the performance of their duties. 3. Any payment by the Joint Undertaking in respect of the liability referred to in paragraphs 1 and 2, and the costs and expenses incurred in that respect, shall be considered as expenditure of the Joint Undertaking and shall be covered by its resources. 4. The Joint Undertaking shall be solely responsible for meeting its obligations. 5. The Joint Undertaking shall not be held liable for any damage resulting from the actions of the hosting entity regarding the operation by the hosting entity of the supercomputers owned by the EuroHPC Joint Undertaking. Article 24 Monitoring and evaluation 1. The activities of the Joint Undertaking shall be subject to continuous monitoring and periodic reviews in accordance with its financial rules, to ensure the highest impact and excellence, as well as the most effective and efficient use of resources. The outcomes of monitoring and periodic reviews shall feed into the monitoring of European Partnerships and evaluations of the Joint Undertaking as part of the Horizon Europe evaluations referred to in Articles 50 and 52 of Regulation (EU) 2021/695. 2. The Joint Undertaking shall organise the continuous monitoring of its management and implementation activities and periodic reviews of the outputs, results and impacts of the projects implemented in line with Article 50 of, and Annex III to, Regulation (EU) 2021/695. 3. Evaluations of the Joint Undertakings\u2019 operations shall be carried out in a timely manner to feed into the interim evaluation and final evaluation of Horizon Europe and the related decision-making process as specified in Article 52 of Regulation (EU) 2021/695. 4. The Commission shall carry out an interim and a final evaluation of the Joint Undertaking as part of the Horizon Europe evaluations referred to in Article 52 of Regulation (EU) 2021/695. The interim evaluation shall be performed with the assistance of independent experts on the basis of a transparent process once there is sufficient information available about the implementation of Horizon Europe, but no later than four years after the start of the implementation of Horizon Europe. The evaluations shall examine how the Joint Undertaking fulfils its mission in accordance with its economic, technological, scientific, societal and policy objectives, including climate-related objectives, and evaluate the effectiveness, efficiency, relevance, coherence, and Union added value of its activities as part of Horizon Europe, its synergies and complementarities with relevant European, national and, where relevant, regional initiatives, including synergies with other parts of Horizon Europe, such as missions, clusters or thematic or specific programmes. The evaluations shall take into account the views of stakeholders, at both European and national levels, and shall, where relevant, also include an assessment of the long-term scientific, societal, economic and policy-relevant impact of the Joint Undertaking. They shall also include an assessment of the most effective policy intervention mode for any future action, as well as the relevance and coherence of any possible renewal of the Joint Undertaking in the overall European Partnerships landscape and its policy priorities. 5. On the basis of the conclusions of the interim evaluation referred to in paragraph 4 of this Article, the Commission may act in accordance with Article 7(7) or take any other appropriate action. 6. The Commission may carry out further evaluations of themes or topics of strategic relevance, with the assistance of external independent experts selected on the basis of a transparent process, to examine the progress made by the Joint Undertaking towards the objectives set, identify the factors contributing to the implementation of the activities and identify best practices. By carrying out those further evaluations, the Commission shall fully consider the administrative impact on the Joint Undertaking. 7. The Joint Undertaking shall perform periodic reviews of its activities to inform the interim evaluation and final evaluation of the Joint Undertaking as part of Horizon Europe evaluations referred to in Article 52 of Regulation (EU) 2021/695. 8. Periodic reviews and evaluations shall inform the winding up or possible renewal of the Joint Undertaking, in line with Annex III to Regulation (EU) 2021/695. Within six months after the winding-up of the Joint Undertaking, but no later than two years after the triggering of the winding-up procedure referred to in Article 23 of the Statutes, the Commission shall conduct a final evaluation of the Joint Undertaking. The results of that final evaluation shall be presented to the European Parliament and to the Council. 9. The Commission shall publish and communicate the results of the evaluations of the Joint Undertaking, which shall include conclusions of the evaluation and observations by the Commission, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions as part of the Horizon Europe evaluations referred to in Article 52 of Regulation (EU) 2021/695. Article 25 Jurisdiction of the Court of Justice of the European Union and applicable law 1. The Court of Justice of the European Union shall have jurisdiction: (a) pursuant to any arbitration clause contained in agreements or contracts concluded by the Joint Undertaking, or in its decisions; (b) in disputes relating to compensation for damage caused by the staff of the Joint Undertaking in the performance of their duties; (c) in any dispute between the Joint Undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations or the Conditions of Employment. 2. With regard to any matter not covered by this Regulation or by other Union legal acts, the law of the Member State where the seat of the Joint Undertaking is located shall apply. Article 26 Complaints to the Ombudsman Decisions taken by the Joint Undertaking in implementing this Regulation may form the subject of a complaint to the Ombudsman in accordance with Article 228 TFEU. Article 27 Ex post audits 1. Ex post audits of expenditure on actions funded by the Horizon Europe budget shall be carried out in accordance with Article 53 of Regulation (EU) 2021/695 as part of the Horizon Europe indirect actions, in particular in line with the audit strategy referred to in Article 53(2) of that Regulation. 2. Ex post audits of expenditure on activities funded by the Digital Europe Programme budget shall be carried out by the Joint Undertaking in accordance with Article 27 of Regulation (EU) 2021/694. 3. Ex post audits of expenditure on activities funded by the Connecting Europe Facility budget shall be carried out by the Joint Undertaking in accordance with Article 26 of Regulation (EU) 2021/1153 as part of the Connecting Europe Facility actions. Article 28 Protection of the financial interests of the members 1. The Joint Undertaking shall grant Commission staff and other persons authorised by the respective Joint Undertaking or the Commission, as well as the Court of Auditors or, for the purpose of the audit referred to in Article 8(3), the audit authorities of the Participating States, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits. 2. OLAF and EPPO may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 (14) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (15) and with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with an agreement, a decision or a contract funded under this Regulation. 3. Without prejudice to paragraphs 1 and 2 of this Article, agreements, decisions and contracts resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the respective Joint Undertaking, the Court of Auditors, EPPO and OLAF, and, for the purpose of the audit referred to in Article 8(3), the audit authorities of the Participating States, to conduct such audits, on-the spot checks and investigations in accordance with their respective competences. 4. The Joint Undertaking shall ensure that the financial interests of its members are adequately protected by carrying out or commissioning appropriate internal and external controls. 5. The Joint Undertaking shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-fraud Office (OLAF) (16). The Joint Undertaking shall adopt the necessary measures needed to facilitate internal investigations conducted by OLAF. Article 29 Confidentiality The Joint Undertaking shall ensure the protection of sensitive information the disclosure of which could damage the interests of its members or of participants in the activities of the Joint Undertaking. Article 30 Transparency Regulation (EC) No 1049/2001 of the European Parliament and of the Council (17) shall apply to documents held by the Joint Undertaking. Article 31 Processing of personal data Where the implementation of this Regulation requires the processing of personal data, they shall be processed in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (18). Article 32 Access to results and information on proposals 1. The Joint Undertaking shall provide the Union institutions, bodies, offices or agencies, as well as the authorities of Participating States, access to all information related to the indirect actions it funds. Such information shall include results of beneficiaries participating in indirect actions of the Joint Undertaking or any other information deemed necessary for developing, implementing, monitoring and evaluating Union policies or programmes. Such access rights are limited to non-commercial and non-competitive use and shall comply with applicable confidentiality rules. 2. For the purposes of developing, implementing, monitoring and evaluating Union policies or programmes, the Joint Undertaking shall provide the Commission with information included in submitted proposals. This shall apply mutatis mutandis to Participating States regarding proposals which include applicants established in their territories, limited to non-commercial and non-competitive use and in accordance with applicable confidentiality rules. Article 33 Rules for participation and dissemination applicable to indirect actions funded under Horizon Europe 1. Regulation (EU) 2021/695 shall apply to the indirect actions funded by the Joint Undertaking under Horizon Europe. In accordance with that Regulation, the Joint Undertaking shall be considered as a funding body and shall provide financial support to indirect actions as set out in Article 1 of the Statutes. 2. Regulation (EU) 2021/695 shall also apply to the indirect actions funded by the Participating State contributions referred to in Article 15(3)(f) of the Statutes. Article 34 Reimbursement rates For indirect actions funded under Horizon Europe, by way of derogation from Article 34 of Regulation (EU) 2021/695, and for activities funded under the Digital Europe Programme, the Joint Undertaking may apply different reimbursement rates for Union funding within an action depending on the type of participant, namely SMEs, and the type of action. The reimbursement rates shall be indicated in the work programme. Article 35 Rules applicable to the activities funded under the Connecting Europe Facility Regulation (EU) 2021/1153 shall apply to the activities funded by the Joint Undertaking under the Connecting Europe Facility. Article 36 Rules applicable to the activities funded under the Digital Europe Programme Regulation (EU) 2021/694 shall apply to the activities funded by the Joint Undertaking under the Digital Europe Programme. Article 37 Support from the host Member State An administrative agreement may be concluded between the Joint Undertaking and the Member State where its seat is located concerning privileges and immunities and other support to be provided by that State to the Joint Undertaking. Article 38 Repeal 1. Without prejudice to actions initiated under Regulation (EU) 2018/1488, including annual implementation plans and financial obligations related to those actions, Regulation (EU) 2018/1488 is repealed. As regards the actions initiated under Articles 10, 11, 13 and 14 of Regulation (EU) 2018/1488, as well as Articles 6 and 7 of the Statutes annexed to that Regulation, it shall continue to apply until their completion and to the extent necessary. Actions arising from calls for proposals and calls for tenders provided for in annual implementation plans adopted under Regulation (EU) 2018/1488 shall also be regarded as actions initiated under that Regulation. 2. References to Regulation (EU) 2018/1488 shall be construed as references to this Regulation. Article 39 Transitional provisions 1. This Regulation shall not affect the rights and obligations of staff engaged under Regulation (EU) 2018/1488. To that effect, the employment contracts of staff shall continue under this Regulation in accordance with the Staff Regulations and Conditions of Employment. 2. The Executive Director appointed under Regulation (EU) 2018/1488 shall, for the remaining period of the term of office, be assigned to the functions of the Executive Director provided for in this Regulation with effect from the entry into force of this Regulation. The other conditions of contract shall remain unchanged. 3. Unless otherwise agreed between members, all rights and obligations, including assets, debts or liabilities of the members held pursuant to Regulation (EU) 2018/1488, shall be transferred to the members pursuant to this Regulation. 4. At its first meeting after the entry into force of this Regulation, the Governing Board shall adopt a list of decisions adopted under Regulation (EU) 2018/1488 that shall continue to apply under this Regulation. Any unused appropriations under Regulation (EU) 2018/1488 shall be transferred to the Joint Undertaking established under this Regulation. 5. All rights and obligations including assets, debts or liabilities of the Joint Undertaking and any unused appropriations under Regulation (EU) 2018/1488 shall be transferred to the Joint Undertaking established under this Regulation. Article 40 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 13 July 2021. For the Council The President A. \u0160IRCELJ (1) Opinion of 24 June 2021 (not yet published in the Official Journal). (2) Opinion of 27 January 2021 (OJ C 123, 9.4.2021, p. 7). (3) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (4) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, p. 1). (5) Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (OJ L 249, 14.7.2021, p. 38). (6) Council Regulation (EU) 2018/1488 of 28 September 2018 establishing the European High Performance Computing Joint Undertaking (OJ L 252, 8.10.2018, p. 1). (7) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). (8) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (9) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (10) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1). (11) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (12) OJ L 282, 19.10.2016, p. 4. (13) OJ L 56, 4.3.1968, p. 1. (14) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (15) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (16) OJ L 136, 31.5.1999, p. 15. (17) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (18) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). ANNEX STATUTES OF THE EUROPEAN HIGH PERFORMANCE COMPUTING JOINT UNDERTAKING Article 1 Tasks The Joint Undertaking shall carry out the following tasks: (a) mobilise public and private sector funds for the financing of the activities of the Joint Undertaking; (b) support the implementation of the mission, the objectives and the pillars of activities of the Joint Undertaking listed in Articles 3 and 4 of this Regulation; those activities will be funded by the Union\u2019s budget stemming from Regulation (EU) 2021/695 establishing Horizon Europe, Regulation (EU) 2021/694 establishing Digital Europe Programme and Regulation (EU) 2021/1153 establishing the Connecting Europe Facility, in accordance with the scope of their respective Regulations and by contributions from the relevant Participating States to the Joint Undertaking; for that purpose the Joint Undertaking shall launch calls for proposals, calls for tenders, and any other instrument or procedure provided for in Horizon Europe, the Digital Europe Programme, and the Connecting Europe Facility; (c) initiate and manage the calls for expression of interest for hosting or upgrading EuroHPC supercomputers and evaluate the offers received, with the support of independent external experts; (d) select the hosting entity of the EuroHPC supercomputers in a fair, open and transparent manner, in accordance with Article 9 of this Regulation; (e) conclude a hosting agreement in accordance with Article 10 of this Regulation with the hosting entity for the operation and maintenance of the EuroHPC supercomputers and monitor the contractual compliance with the hosting agreement, including the acceptance test of the acquired supercomputers; (f) define general and specific conditions for allocating the Union\u2019s share of access time to the EuroHPC supercomputers and monitor access to those supercomputers in accordance with Article 17 of this Regulation; (g) ensure the contribution of its operations to the achievement of the objectives of Horizon Europe, the strategic multiannual planning, reporting, monitoring and evaluation and other requirements of that programme such as the implementation of the common policy feedback framework; (h) initiate open calls for proposals and award funding in accordance with Regulation (EU) 2021/695, and within the limits of available funds, to indirect actions, mainly in the form of grants; (i) initiate open calls for proposals and calls for tenders and award funding in accordance with Regulation (EU) 2021/694 and Regulation (EU) 2021/1153 within the limits of available funds; (j) monitor the implementation of the actions and manage grant agreements and procurement contracts; (k) ensure the efficiency of the European High Performance Computing initiative, on the basis of a set of appropriate measures; (l) monitor overall progress towards achieving the objectives of the Joint Undertaking; (m) develop close cooperation and ensure coordination with Union and national activities, bodies and stakeholders, creating synergies and improving exploitation of research and innovation results in the area of High Performance Computing; (n) develop close cooperation and ensure coordination with other European Partnerships, as well as operational synergies in common back office functions with other Joint Undertakings; (o) define the multiannual strategic programme, draw up and implement the corresponding annual work programmes for their execution and make any necessary adjustments to the multiannual strategic programme; (p) engage in information, communication, exploitation and dissemination activities by applying mutatis mutandis Article 51 of Regulation (EU) 2021/695, including making the detailed information on results from calls for proposals available and accessible in a common Horizon Europe e-database; (q) perform any other task needed to achieve the objectives set out in Article 3 of this Regulation. Article 2 Members 1. The members of the Joint Undertaking shall be: (a) the Union, represented by the Commission; (b) Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden; (c) Montenegro, North Macedonia, Switzerland and Turkey, on the condition that those third countries are associated to at least one of the relevant programmes referred to in Article 5(1) of this Regulation; (d) upon acceptance of these Statutes by means of a letter of endorsement, the European Technology Platform for High Performance Computing (ETP4HPC) Association registered under Dutch law with its registered office in Amsterdam (the Netherlands) and Data, AI and Robotics (DAIRO) registered under Belgian law with its registered office in Brussels (Belgium). 2. Each Participating State shall appoint its representative in the Governing Board and shall designate the national entity or entities responsible for fulfilling its obligations under this Regulation. Article 3 Changes to membership 1. Provided that they contribute in accordance with Article 7 of this Regulation or to the financing referred to in Article 15 of these Statutes to achieve the mission and objectives of the Joint Undertaking set out in Article 3 of this Regulation, Member States or third countries associated to Horizon Europe or the Digital Europe Programme that are not listed in Article 2(1)(b) of these Statutes may apply to become members of the Joint Undertaking. 2. Any application of a Member State or a third country associated to Horizon Europe or the Digital Europe Programme for membership of the Joint Undertaking shall be addressed to the Governing Board. The candidate countries shall provide a written acceptance of these Statutes, and of any other provisions governing the functioning of the Joint Undertaking. The candidates shall also provide their motivation for requesting membership to the Joint Undertaking and indicate how their national supercomputing strategy is aligned with the Joint Undertaking\u2019s objectives. The Governing Board shall assess the application, taking into account the relevance and the potential added value of the candidate as regards the achievement of the mission and objectives of the Joint Undertaking and may decide to ask for clarifications regarding the candidature before endorsing the application. 3. Provided that it contributes to the financing referred to in Article 15 of these Statutes to achieve the mission and objectives of the Joint Undertaking set out in Article 3 of this Regulation, and that it accepts these Statutes, any legal entity that is not listed in Article 2(1)(c) of these Statutes and is established in a Member State that directly or indirectly supports research and innovation in a Member State may apply to become a Private Member of the Joint Undertaking in accordance with paragraph 4 of this Article. 4. Any application for membership to become a Private Member of the Joint Undertaking made in accordance with paragraph 3 shall be addressed to the Governing Board. The Governing Board shall assess the application, taking into account the relevance and the potential added value of the applicant as regards the achievement of the mission and objectives of the Joint Undertaking and shall decide on the application. 5. Any member may terminate its membership in the Joint Undertaking. Such termination shall become effective and irrevocable six months after notification to the Executive Director, who shall inform the other members of the Governing Board and the Private Members thereof. As from the date of termination, the former member shall be discharged from any obligations other than those approved or incurred by the Joint Undertaking prior to the notification of termination of the membership. 6. Each Private Member shall inform the Joint Undertaking once a year of any significant changes in the composition of the Private Member. Where the Commission considers that the change in composition is likely to affect the Union\u2019s or the Joint Undertaking\u2019s interests on grounds of security, it may propose to the Governing Board to terminate the membership of the concerned Private Member. The termination shall become effective and irrevocable within six months of the decision of the Governing Board or on the date specified in that decision, whichever is earlier. 7. Membership in the Joint Undertaking may not be transferred to a third party without the prior agreement of the Governing Board. 8. Upon any change to the membership pursuant to this Article, the Joint Undertaking shall immediately publish on its website an updated list of the members together with the date of such change. Article 4 Bodies of the Joint Undertaking 1. The bodies of the Joint Undertaking shall be: (a) the Governing Board; (b) the Executive Director; (c) the Industrial and Scientific Advisory Board composed of the Research and Innovation Advisory Group and the Infrastructure Advisory Group. 2. When carrying out its tasks, each body of the Joint Undertaking shall only pursue the objectives set out in this Regulation and shall only act within the scope of the activities of the Joint Undertaking for the purpose of which it was established. Article 5 Composition of the Governing Board 1. The Governing Board shall be composed of representatives of the Commission, on behalf of the Union, and of the Participating States. 2. The Commission and each Participating State shall appoint one representative to the Governing Board. Article 6 Functioning of the Governing Board 1. The representatives of the members of the Governing Board shall make every effort to achieve consensus. Failing consensus, a vote shall be held. 2. The Union shall hold 50 % of the voting rights. The voting rights of the Union shall be indivisible. 3. For the tasks referred to in Article 7(3) of these Statutes, the remaining 50 % of the voting rights shall be distributed equally among all Participating States. For the purpose of this paragraph, decisions of the Governing Board shall be taken by a majority consisting of the Union\u2019s vote and at least 50 % of all votes of the Participating States, including the votes of the members who are absent. 4. For the tasks referred to in Article 7(4) of these Statutes, except points (f), (g) and (h), the remaining 50 % of the voting rights shall be held by the Participating States that are Member States. For the purpose of this paragraph, decisions of the Governing Board shall be taken by a qualified majority. Qualified majority shall be deemed established if it represents the Union and at least 55 % of the Participating States that are Member States, comprising at least 65 % of the total population of these States. To determine the population, the figures set out in Annex III to Council Decision 2009/937/EU (1) shall be used. 5. For the tasks referred to in Article 7(4)(f), (g) and (h) of these Statutes, and for each EuroHPC supercomputer, the voting rights of the Participating States shall be distributed in proportion to their committed financial contributions and to their in-kind contributions to that supercomputer until either its ownership is transferred to the hosting entity in accordance with Article 9(3) of this Regulation or until it is sold or decommissioned; the in-kind contributions shall only be taken into account if they have been certified ex ante by an independent expert or auditor. For the purpose of this paragraph, decisions of the Governing Board shall be taken by a majority of at least 75 % of all votes, including the votes of the members who are absent. 6. For the tasks referred to in Article 7(5), 7(6) and 7(7) of these Statutes, decisions of the Governing Board shall be taken in two stages. At the first stage, the remaining 50 % of the voting rights shall be distributed equally among all Participating States. Decisions of the Governing Board shall be taken by a majority consisting of the Union\u2019s vote and at least 55 % of all votes of Participating States, including the votes of the members who are absent. At the second stage, the Governing Board shall decide by the qualified majority referred to in paragraph 4 of this Article. 7. Without prejudice to the previous paragraphs, countries that were members of the Joint Undertaking under Regulation (EU) 2018/1488 and contributed to the acquisition or operation of the supercomputers acquired by the EuroHPC Joint Undertaking, established under that Regulation, but which are no longer members of the EuroHPC Joint Undertaking, shall maintain voting rights limited exclusively to decisions relating to those supercomputers in accordance with Articles 6(5) and 7(5) of the Statutes of the EuroHPC Joint Undertaking annexed to Regulation (EU) 2018/1488. 8. The Governing Board shall elect a chair for a period of two years. The mandate of the chairperson may be extended only once, following a decision by the Governing Board. 9. The vice chair of the Governing Board shall be the representative of the Commission, substituting the chair where necessary. 10. The Governing Board shall hold its ordinary meetings at least twice a year. It may hold extraordinary meetings at the request of the Commission, of a majority of the representatives of the Participating States, at the request of the chair, or at the request of the Executive Director in accordance with Article 15(5) of these Statutes. The meetings of the Governing Board shall be convened by its chair and shall usually take place at the seat of the Joint Undertaking. The Executive Director shall have the right to attend the meetings and take part in the deliberations but shall have no voting rights. The Governing Board may invite, on a case-by-case basis, other persons to attend its meetings as observers. Each observer State may appoint one delegate in the Governing Board, who shall receive all relevant documents and may participate in the deliberations of the Governing Board unless decided otherwise by the Governing Board on a case-by-case basis. Those delegates shall have no voting rights and shall ensure the confidentiality of sensitive information in accordance with Article 29 of this Regulation and be subject to the rules of conflict of interest. 11. The representatives of the members shall not be personally liable for any actions they have taken in their capacity as representatives on the Governing Board. 12. The Governing Board shall adopt and publish its own rules of procedure. Those rules shall include specific procedures for identifying and avoiding conflicts of interest and for ensuring the confidentiality of sensitive information. 13. The chairs of the Research and Innovation Advisory Group and of the Infrastructure Advisory Group of the Joint Undertaking shall be invited, whenever issues falling within their tasks are discussed, to attend meetings of the Governing Board as observers and take part in its deliberations, but shall have no voting rights. They shall ensure the confidentiality of sensitive information in accordance with Article 29 of this Regulation and be subject to the rules of conflict of interest. 14. The chairs of the Private Members of the Joint Undertaking shall be invited to attend the meetings of the Governing Board as observers and take part in its deliberations, but shall have no voting rights. They shall ensure the confidentiality of sensitive information in accordance with Article 29 of this Regulation and be subject to the rules of conflict of interest. Article 7 Tasks of the Governing Board 1. The Governing Board shall have overall responsibility for the strategic orientation and the operations of the Joint Undertaking and shall supervise the implementation of its activities. It shall ensure that the principles of fairness and transparency are properly applied in the allocation of public funding. 2. The Commission, in its role in the Governing Board, shall seek to ensure coordination between the activities of the Joint Undertaking and the relevant activities of Union funding programmes with a view to promoting synergies when developing an integrated supercomputing and data infrastructure ecosystem and when identifying priorities covered by collaborative research. 3. The Governing Board shall, in particular, carry out the following general administrative tasks of the Joint Undertaking: (a) assess, accept or reject applications for membership in accordance with Article 3(2) of these Statutes; (b) decide on the termination of membership in the Joint Undertaking of any member that does not fulfil its obligations; (c) discuss and adopt the financial rules of the Joint Undertaking in accordance with Article 19 of this Regulation; (d) discuss and adopt the annual administrative budget of the Joint Undertaking, including the corresponding staff establishment plan indicating the number of temporary posts by function group and by grade, the number of contract staff and seconded national experts expressed in full-time equivalents; (e) appoint, dismiss, extend the term of office of, provide guidance to and monitor the performance of the Executive Director; (f) discuss and approve the consolidated annual activity report, including the corresponding expenditure referred to in Article 18(1) of these Statutes; (g) exercise the powers of the appointing authority with respect to staff in accordance with Article 20 of this Regulation; (h) where appropriate, establish implementing rules to the Staff Regulations and the Conditions of Employment in accordance with Article 20(3) of this Regulation; (i) where appropriate, lay down rules on the secondment of national experts to the Joint Undertaking and on the use of trainees in accordance with Article 21(2) of this Regulation; (j) where appropriate, set up advisory groups in addition to the bodies of the Joint Undertaking referred to in Article 4 of these Statutes; (k) lay down rules and specific criteria for the selection, appointment and dismissal of members of the advisory groups set up in accordance with point (j), including considerations of gender and geographical diversity, and approve the rules of procedure laid down autonomously by these advisory groups; (l) discuss and approve the organisational structure of the Programme Office upon recommendation of the Executive Director; (m) where appropriate, submit to the Commission a request to amend this Regulation proposed by a member of the Joint Undertaking; (n) define the general and specific access conditions to use the Union\u2019s share of access time of the EuroHPC supercomputers, in accordance with Article 17 of this Regulation; (o) establish the level of the fee of the commercial services referred to in Article 18 of this Regulation, and decide on the allocation of the access time for those services; (p) discuss and approve the Joint Undertaking\u2019s communication policy upon recommendation by the Executive Director; (q) be responsible for any task that is not specifically allocated to a particular body of the Joint Undertaking; it may assign such tasks to any body of the Joint Undertaking. 4. The Governing Board shall, in particular, carry out the following tasks related to the acquisition and operation of the EuroHPC supercomputers and generated revenues referred to in Article 16 of this Regulation: (a) discuss and adopt the part of the multiannual strategic programme that is related to the acquisition of EuroHPC supercomputers referred to in Article 18(1) of these Statutes; (b) discuss and adopt the part of the annual work programme that is related to the acquisition of EuroHPC supercomputers and the selection of hosting entities and the corresponding expenditure estimates referred to in Article 18(4) of these Statutes; (c) approve the launch of calls for expression of interest, in accordance with the annual work programme; (d) approve the selection of the hosting entities for the EuroHPC supercomputers selected through a fair, open and transparent process in accordance with Article 9 of this Regulation; (e) decide annually on the use of any revenue generated by the fees for commercial services referred to in Article 18 of this Regulation; (f) approve the launch of calls for tenders, in accordance with the annual work programme; (g) approve the tenders selected for funding; (h) decide on the possible transfer of ownership of the EuroHPC supercomputers to a hosting entity, their sale to another entity or their decommissioning, in accordance with Articles 11(5), 12(7) and 14(6) of this Regulation; (i) decide on the possible transfer of ownership of the EuroHPC supercomputers to a consortium of private partners, their sale to another entity or their decommissioning, in accordance with Article 13(6) of this Regulation. 5. The Governing Board shall, in particular, carry out the following tasks related to the research and innovation activities, as well as the data use and skills activities of the Joint Undertaking: (a) discuss and adopt the part of the multiannual strategic programme that is related to the research and innovation activities referred to in Article 18(1) of these Statutes at the beginning of the initiative and amend it throughout the duration of Horizon Europe, if necessary; the multiannual strategic programme shall identify, inter alia, the other European partnerships with which the Joint Undertaking shall establish a formal and regular collaboration, as well as possibilities for synergies between the Joint Undertaking\u2019s actions and national or regional initiatives and policies based on information received by the Participating States; (b) discuss and adopt the part of the annual work programme that is related to the research and innovation activities and the corresponding expenditure estimates referred to in Article 18(4) of these Statutes to implement the multiannual strategic programme, including the content of the calls for proposals, the applicable funding rate per call topic, as well as the related rules for submission, evaluation, selection, award and review procedures; (c) approve the launch of calls for proposals, in accordance with the annual work programme; (d) approve the list of actions selected for funding on the basis of the recommendation of the Executive Director pursuant to Article 8 of this Regulation; (e) be responsible for the close and timely monitoring of the progress of the Joint Undertaking\u2019s research and innovation programme and individual actions in relation to the priorities of the Commission and the multiannual strategic programme and take corrective measures where needed to ensure that the Joint Undertaking meets its objectives. 6. The Governing Board shall, in particular, carry out the following tasks related to the capability building and widening activities of the Joint Undertaking: (a) discuss and adopt the part of the multiannual strategic programme that is related to the capability building and widening activities referred to in Article 18(1) of these Statutes; (b) discuss and adopt the part of the annual work programme that is related to the capability building and widening activities and the corresponding expenditure estimates referred to in Article 18(4) of these Statutes; (c) approve the launch of calls for proposals and calls for tenders, in accordance with the annual work programme; (d) approve the list of actions selected for funding on the basis of the recommendation of the Executive Director. 7. The Governing Board shall, in particular, carry out the following tasks related to the federation and connectivity of the High Performance Computing and data infrastructure activities, as well as the international cooperation activities of the Joint Undertaking: (a) discuss and adopt the part of the multiannual strategic programme that is related to the federation and connectivity of the High Performance Computing and data infrastructure activities, as well as the international cooperation activities referred to in Article 18(1) of these Statutes; (b) discuss and adopt the part of the annual work programme that is related to the federation and connectivity of the High Performance Computing and data infrastructure activities, as well as to the international cooperation activities and the corresponding expenditure estimates referred to in Article 18(4) of these Statutes; (c) approve the launch of calls for proposals and calls for tenders, in accordance with the annual work programme; (d) approve the list of actions selected for funding on the basis of the recommendation of the Executive Director. Article 8 Appointment, dismissal or extension of the term of office of the Executive Director 1. The Commission shall propose a list of candidates for Executive Director after consultation of the members of the Joint Undertaking other than the Union. For the purpose of such consultation the members of the Joint Undertaking other than the Union shall appoint by common accord their representatives as well as an observer on behalf of the Governing Board. The Executive Director shall be appointed by the Governing Board from a list of candidates proposed by the Commission following an open and transparent selection procedure. 2. The Executive Director shall be a member of staff and shall be engaged as a temporary agent of the Joint Undertaking under Article 2(a) of the Conditions of Employment. For the purpose of concluding the contract of the Executive Director, the Joint Undertaking shall be represented by the chair of the Governing Board. 3. The term of office of the Executive Director shall be four years. By the end of that period, the Commission, associating the members other than the Union as appropriate, shall undertake an assessment of the performance of the Executive Director and the Joint Undertaking\u2019s future tasks and challenges. 4. The Governing Board, acting on a proposal from the Commission which takes into account the assessment referred to in paragraph 3, may extend the term of office of the Executive Director once, for a period of no more than four years. 5. An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period. 6. The Executive Director may be dismissed only upon a decision of the Governing Board pursuant to Article 7(3)(e) of these Statutes acting on a proposal from the Commission associating the members other than the Union as appropriate. 7. The Commission may designate a Commission official to act as interim Executive Director and exercise the duties assigned to the Executive Director for any period that the position of Executive Director is vacant. Article 9 Tasks of the Executive Director 1. The Executive Director shall be the chief executive responsible for the day-to-day management of the Joint Undertaking in accordance with the decisions of the Governing Board. 2. The Executive Director shall be the legal representative of the Joint Undertaking. The Executive Director shall be accountable to the Governing Board and perform his or her duties with complete independence within the powers assigned to him or her. 3. The Executive Director shall implement the budget of the Joint Undertaking. 4. The Executive Director shall carry out, in particular, the following tasks in an independent manner: (a) submit for discussion and adoption to the Governing Board the draft multiannual strategic programme referred to in Article 18(1) of these Statutes; (b) prepare and submit to the Governing Board for discussion and adoption the draft annual budget, including the corresponding staff establishment programme indicating the number of temporary posts in each grade and function group and the number of contract staff and seconded national experts expressed in full-time equivalents; (c) prepare and submit to the Governing Board for discussion and adoption the draft annual work programme including the scope of the calls for proposals, calls for expression of interest and calls for tenders needed to implement the research and innovation activities programme, the procurement programme, the capability building and widening activities programme and the federation, connectivity and international cooperation activities programme, as proposed by the Industrial and Scientific Advisory Board, and the corresponding expenditure estimates, as proposed by the Participating States and the Commission; (d) submit the annual accounts to the Governing Board for its opinion; (e) prepare and submit for approval to the Governing Board the consolidated annual activity report, including the information on corresponding expenditure; (f) sign individual grant agreements, contracts and decisions in his or her remit on behalf of the Joint Undertaking; (g) sign procurement contracts; (h) monitor the operations of the EuroHPC supercomputers owned or funded by the Joint Undertaking, including the allocation of the Union\u2019s share of access time, compliance with the access rights for academic and industrial users and quality of provided services; (i) propose the Joint Undertaking\u2019s communication policy to the Governing Board; (j) organise, direct and supervise the operations and the staff of the Joint Undertaking within the limits of the delegation by the Governing Board as provided for in Article 20(2) of this Regulation; (k) establish and ensure the functioning of an effective and efficient internal control system and report any significant change to it to the Governing Board; (l) ensure that risk assessment and risk management are performed; (m) arrange, as appropriate, for the establishment of an internal audit capability of the Joint Undertaking; (n) allocate access time for emergencies and crisis management, in agreement with the access policy defined by the Governing Board; (o) take any other measures needed to assess the progress of the Joint Undertaking towards its objectives, as set out in Article 3 of this Regulation; (p) perform any other tasks entrusted or delegated to the Executive Director by the Governing Board. 5. The Executive Director shall set up a Programme Office for the execution, under his or her responsibility, of all support tasks arising from this Regulation. The Programme Office shall be composed of the staff of the Joint Undertaking and shall in particular carry out the following tasks: (a) provide support in establishing and managing an appropriate accounting system in accordance with the financial rules referred to in Article 19 of this Regulation; (b) manage the calls for proposals as provided for in the annual work programme and administer the grant agreements and decisions; (c) manage the calls for tenders as provided for in the annual work programme and administer the contracts; (d) manage the process for the selection of the hosting entities and administer the hosting agreements; (e) provide the members and the other bodies of the Joint Undertaking with all relevant information and support necessary for them to perform their duties, as well as respond to their specific requests; (f) act as the secretariat of the bodies of the Joint Undertaking and provide support to advisory groups set up by the Governing Board. Article 10 Composition of the Industrial and Scientific Advisory Board 1. The Industrial and Scientific Advisory Board shall be composed of a Research and Innovation Advisory Group and an Infrastructure Advisory Group. 2. The Research and Innovation Advisory Group shall consist of no more than twelve members, of which up to six shall be appointed by the Private Members taking into account their commitments to the Joint Undertaking and up to six shall be appointed by the Governing Board, in accordance with Article 7(3)(k) of these Statutes. 3. The Research and Innovation Advisory Group may include up to six observers proposed by Participating States and appointed by the Governing Board. 4. The Infrastructure Advisory Group shall consist of twelve members. The Governing Board shall appoint the members of the Infrastructure Advisory Group, in accordance with Article 7(3)(k) of these Statutes. 5. The members of the Research and Innovation Advisory Group and of the Infrastructure Advisory Group shall be appointed for a period of up to two years, renewable once. 6. The Research and Innovation Advisory Group and the Infrastructure Advisory Group shall meet at least once a year in order to coordinate their activities. Article 11 Functioning of the Research and Innovation Advisory Group 1. The Research and Innovation Advisory Group shall meet at least twice a year. 2. The Research and Innovation Advisory Group may appoint working groups where necessary under the overall coordination of one or more members. 3. The Research and Innovation Advisory Group shall elect its chair. 4. The Research and Innovation Advisory Group shall adopt its rules of procedure, including the nomination of the constituent entities that shall represent the Advisory Group and the duration of their nomination. Article 12 Functioning of the Infrastructure Advisory Group 1. The Infrastructure Advisory Group shall meet at least twice a year. 2. The Infrastructure Advisory Group may appoint working groups where necessary under the overall coordination of one or more members. 3. The Infrastructure Advisory Group shall elect its chair. 4. The Infrastructure Advisory Group shall adopt its rules of procedure, including the nomination of the constituent entities that shall represent the Advisory Group and the duration of their nomination. Article 13 Tasks of the Research and Innovation Advisory Group 1. The Research and Innovation Advisory Group shall: (a) draw up its contribution to the draft multiannual strategic programme in relation to research and innovation activities referred to in Article 18(1) of these Statutes and review it regularly in accordance with the evolution of the scientific and industrial demand; (b) organise public consultations open to all public and private stakeholders having an interest in the fields of High Performance Computing and quantum computing to inform them about, and collect feedback on, the draft multiannual strategic programme and the related draft activities of the research and innovation work programme for a given year. 2. The contribution to the draft multiannual strategic programme referred to in paragraph 1 shall include: (a) the strategic research and innovation agenda identifying the research and innovation priorities for the development and uptake of technologies and end-user applications for High Performance Computing across different application areas, in order to support the development of an integrated High Performance Computing, quantum computing and data ecosystem in the Union, to increase the Union\u2019s resilience and to help create new markets and societal applications and measures to promote the development and uptake of European technology; (b) potential international cooperation activities in research and innovation that add value and are of mutual interest; (c) training and education priorities for addressing key competences and the skills gap in High Performance Computing and quantum computing technologies and applications, in particular for industry. Article 14 Tasks of the Infrastructure Advisory Group 1. The Infrastructure Advisory Group shall provide advice to the Governing Board for the acquisition and operation of the EuroHPC supercomputers. For that purpose, it shall: (a) draw up its contribution to the draft multiannual strategic programme referred to in Article 18(1) of these Statutes in relation to acquisition of EuroHPC computers and capability building and widening activities and review it regularly in accordance with the evolution of scientific and industrial demand; (b) organise public consultations open to all public and private stakeholders having an interest in the field of High Performance Computing, including quantum computing, to inform them about, and collect feedback on, the draft multiannual strategic programme for the acquisition and operation of the EuroHPC supercomputers and the related draft activities of the work programme for a given year. 2. The contribution to the draft multiannual strategic programme referred to in paragraph 1 shall address: (a) the acquisition of the EuroHPC supercomputers taking into account, inter alia, the planning of the acquisition, the needed capacity increases, the types of applications and user communities to be addressed, the relevant user requirements and appropriate system architectures, the user requirements, and the architecture of the infrastructure; (b) the federation and interconnection of this infrastructure, taking into account, inter alia, the integration with national High Performance Computing or quantum computing infrastructures, and the architecture of the hyper-connected and federated infrastructure; and (c) the capability building, including the national High Performance Computing Competence Centres and widening and training activities for end-users, as well as opportunities for promoting the take-up and use of European technology solutions notably by the national High Performance Computing Competence Centres. Article 15 Sources of financing 1. The Joint Undertaking shall be jointly funded by its members through financial contributions paid in instalments and in-kind contributions as set out in paragraphs 2 and 3. 2. The administrative costs of the Joint Undertaking shall not exceed EUR 92 000 000 and shall be covered by means of the financial contributions referred to in Article 5(1) of this Regulation. If part of the Union contribution for administrative costs is not used, it may be made available to cover the operational costs of the Joint Undertaking. 3. The operational costs of the Joint Undertaking shall be covered by means of: (a) the Union\u2019s financial contribution; (b) financial contributions by the Participating State where the hosting entity is established or by the Participating States in a hosting consortium to the Joint Undertaking, including the Union contributions that are considered to be contributions of the Participating State pursuant to Article 15(3) of Regulation (EU) 2021/695, for the acquisition of the high-end EuroHPC supercomputers or quantum machines and for their operation until their ownership is transferred to the hosting entity, they are sold or decommissioned in accordance with Articles 11(5) and 12(7) of this Regulation, less the contributions by the Joint Undertaking and any other Union contribution to those costs; (c) in-kind contributions by the Participating State where the hosting entity is established or by the Participating States in a hosting consortium, including the Union contributions that are considered to be contributions of the Participating State pursuant to Article 15(3) of Regulation (EU) 2021/695, consisting of the operating costs of the EuroHPC supercomputers owned by the Joint Undertaking, incurred by the hosting entities, less the contributions by the Joint Undertaking and any other Union contribution to those costs; (d) financial contributions by the Participating State where the hosting entity is established or by the Participating States in a hosting consortium, including the Union contributions that are considered to be contributions of the Participating State pursuant to Article 15(3) of Regulation (EU) 2021/695, consisting of the costs incurred for the acquisition, jointly with the Joint Undertaking, of the mid-range EuroHPC supercomputers, less the contributions by the Joint Undertaking and any other Union contribution to those costs; (e) financial contributions by a consortium of private partners consisting of the costs incurred for the acquisition and operation, jointly with the Joint Undertaking, of the industrial-grade EuroHPC supercomputers, less the contributions by the Joint Undertaking and any other Union contribution to those costs, until their ownership is transferred to the hosting entity, they are sold or decommissioned in accordance with Article 13(6) of this Regulation; (f) financial contributions by Participating States to the eligible costs incurred by beneficiaries established in that Participating State, including the Union contributions that are considered to be contributions of the Participating State pursuant to Article 15(3) of Regulation (EU) 2021/695, in implementing indirect actions corresponding to the research and innovation agenda as a complement to the reimbursement of these costs made by the Joint Undertaking, less the contributions by the Joint Undertaking and any other Union contribution to those costs. Such contributions shall be without prejudice to state-aid rules; (g) in-kind contributions by the Private Members or their constituent entities and affiliated entities as defined in Article 9(7) of this Regulation. 4. The resources of the Joint Undertaking entered in its budget shall be composed of the following contributions: (a) Union financial contributions to the administrative costs; (b) members\u2019 financial contributions to the operational costs; (c) any revenue generated by the Joint Undertaking; (d) any other financial contributions, resources and revenues; (e) any interest yielded by the contributions paid to the Joint Undertaking shall be considered to be its revenue. 5. Should any member of the Joint Undertaking be in default of its commitments concerning its financial contribution, the Executive Director shall put this in writing and shall set a reasonable period within which such default shall be remedied. If the situation is not remedied within that period, the Executive Director shall convene a meeting of the Governing Board to decide whether the defaulting member\u2019s membership is to be revoked or whether any other measures are to be taken until its obligations have been met. The defaulting member\u2019s voting rights shall be suspended until the default of its commitments is remedied. The Joint Undertaking or any of its members shall not be obliged to cover the defaulting members\u2019 financial contribution. 6. The resources and activities of the Joint Undertaking shall be intended for the achievement of the objectives set out in Article 3 of this Regulation. 7. The Joint Undertaking shall own all assets generated by it or transferred to it for the achievement of its objectives set out in Article 3 of this Regulation. This shall not include the EuroHPC supercomputers whose ownership the Joint Undertaking has transferred to a hosting entity in accordance with Articles 11(5), 12(7), 13(6) and 14(6) of this Regulation. 8. Except when the Joint Undertaking is wound up, any excess revenue over expenditure shall not be paid to the members of the Joint Undertaking. Article 16 Financial commitments The financial commitments of the Joint Undertaking shall not exceed the amount of financial resources available or committed to its budget by its members. The Commission may provide multi-annual commitments. Article 17 Financial year The financial year shall run from 1 January to 31 December. Article 18 Operational and financial planning 1. The multiannual strategic programme shall specify the strategy and plans for achieving the objectives of the Joint Undertaking set out in Article 3 of this Regulation. It shall include the following: the acquisition of supercomputers; the research and innovation activities including the strategic research and innovation agenda; the capability building and widening activities; the federation, connectivity and international cooperation activities. It shall also include the multiannual financial perspectives received from the Participating States and the Commission. 2. Private Members shall draft the Strategic Research and Innovation Agenda and shall submit it to the Research and Innovation Advisory Group. 3. The Industrial and Scientific Advisory Board shall consolidate the multiannual strategic programme and submit it to the Executive Director. It shall be the basis for the Executive Director to draft the annual work programme. 4. The draft annual work programme shall include the research and innovation activities, the procurement activities, the capability building and widening activities, the federation and connectivity activities, the international cooperation activities, the administrative activities and the corresponding expenditure estimates for the following year. 5. The Executive Director shall submit to the Governing Board the administrative agreements referred to in Article 8(2) of this Regulation supporting the expenditure estimates. 6. The annual work programme shall be adopted by the end of the year prior to its implementation. The annual work programme shall be made publicly available. 7. The Executive Director shall prepare the draft annual budget for the following year and shall submit it to the Governing Board for adoption. 8. The annual budget for a particular year shall be adopted by the Governing Board by the end of the year prior to its implementation. 9. The annual budget shall be adapted in order to take into account the amount of the Union\u2019s financial contribution as set out in the general budget of the Union. Article 19 Operational and financial reporting 1. The Executive Director shall report annually to the Governing Board on the performance of his or her duties in accordance with the financial rules of the Joint Undertaking referred to in Article 19 of this Regulation. The consolidated annual activity report shall include, inter alia, information on the following matters: (a) research, innovation and other actions carried out and the corresponding expenditure; (b) acquisition and operation of infrastructure, including the use of and access to the infrastructure, including the access time effectively used by each Participating State; (c) the proposals and tenders submitted, including a breakdown by participant type, including SMEs, and by country; (d) the indirect actions selected for funding, with a breakdown by participant type, including SMEs, and by country, and indicating the contributions of the Joint Undertaking to the individual participants and actions; (e) the tenders selected for funding, with a breakdown by type of contractor, including SMEs, and by country, and indicating the contributions of the Joint Undertaking to the individual contractors and procurement actions; (f) the outcome of the procurement activities; (g) progress towards the achievement of the objectives set out in Article 3 of this Regulation and proposals for further necessary work to achieve those objectives. 2. The accounting officer of the Joint Undertaking shall send the provisional accounts to the Commission\u2019s accounting officer and the Court of Auditors in accordance with the financial rules of the Joint Undertaking. 3. The Executive Director shall send the report on the budgetary and financial management to the European Parliament, the Council and the Court of Auditors in accordance with the financial rules of the Joint Undertaking. 4. The discharge procedure shall be carried out in accordance with the financial rules of the Joint Undertaking. Article 20 Internal audit 1. The Commission\u2019s internal auditor shall exercise the same powers over the Joint Undertaking as those exercised in respect of the Commission. 2. The Joint Undertaking shall be capable of performing its own internal audit. Article 21 Liability of members and insurance 1. The financial liability of the members of the Joint Undertaking for the debts of the Joint Undertaking shall be limited to their financial contributions made to the Joint Undertaking. 2. The Joint Undertaking shall take out and maintain appropriate insurance. Article 22 Conflict of interest 1. The Joint Undertaking, its bodies and staff shall avoid any conflict of interest in carrying out their activities. 2. The Governing Board shall adopt rules for the prevention and management of conflicts of interest in respect of the persons serving in the Governing Board and in the other bodies or groups of the Joint Undertaking. Article 23 Winding-up 1. The Joint Undertaking shall be wound up at the end of the period laid down in Article 1 of this Regulation. 2. In addition to paragraph 1, the winding-up procedure shall be automatically triggered if the Union or all members other than the Union withdraw from the Joint Undertaking. 3. For the purpose of conducting the proceedings to wind up the Joint Undertaking, the Governing Board shall appoint one or more liquidators, who shall comply with the decisions of the Governing Board. 4. When the Joint Undertaking is being wound up, its assets shall be used to cover its liabilities and the expenditure relating to its winding-up. The supercomputers owned by the Joint Undertaking shall be transferred to the respective hosting entities or consortium of private partners, sold or decommissioned upon decision of the Governing Board and in accordance with the hosting agreement. The members of the Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of a supercomputer or its sale or decommissioning. In the event of transfer of ownership, the hosting entity or the consortium of private partners shall reimburse the Joint Undertaking the residual value of the supercomputers that are transferred. Any surplus shall be distributed among the members at the time of the winding-up in proportion to their financial contribution to the Joint Undertaking. Any such surplus distributed to the Union shall be returned to the general budget of the Union. 5. An ad hoc procedure shall be set up to ensure the appropriate management of any agreement concluded or decision adopted by the Joint Undertaking, as well as any procurement contract with a duration longer than the duration of the Joint Undertaking. (1) Council Decision 2009/937/EU of 1 December 2009 adopting the Council\u2019s Rules of Procedure (OJ L 325, 11.12.2009, p. 35).", "summary": "European High-Performance Computing Joint Undertaking European High-Performance Computing Joint Undertaking SUMMARY OF: Regulation (EU) 2021/1173 establishing the European High-Performance Computing Joint Undertaking WHAT IS THE AIM OF THE REGULATION? As provided for in Article 187 of the Treaty on the Functioning of the European Union, in order to implement the European high-performance computing initiative, the regulation establishes the European High-Performance Computing Joint Undertaking (EuroHPC JU) between the European Union (EU), EU Member States and private partners, for a period until 31 December 2033. Its mission is to develop, deploy, extend and maintain a world-leading consolidated, secure and hyper-connected supercomputing*, quantum-computing*, service and data infrastructure ecosystem. KEY POINTS The regulation builds upon and repeals Regulation (EU) 2018/1488. Objectives and activities The joint undertaking aims to: deliver scientific, economic, environmental, technological and societal results from the EU\u2019s investment in research and innovation; deliver on the EU\u2019s strategic priorities and contribute to its objectives and policies; tackle global challenges, including the United Nations sustainable development goals, by following the principles of the United Nations sustainable development agenda 2030 and the Paris Agreement adopted under the United Nations framework convention on climate change; closely cooperate and coordinate with other European partnership and relevant programmes at EU, national, and regional level; develop, deploy and maintain a hyper-connected supercomputing and data infrastructure in the EU and federate it with European data spaces and a cloud ecosystem; promote scientific excellence and support the uptake and systematic use of research and innovation results generated in the EU; further develop and support a highly competitive and innovative supercomputing and data ecosystem to be broadly distributed in Europe, which contributes to the EU\u2019s scientific and digital leadership, and which is capable of autonomously producing computing systems and advanced applications; widen the use of supercomputing services and develop key skills needed in European science and industry. Joint undertaking members The joint undertaking members are: the EU, represented by the European Commission; Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden; Montenegro, North Macedonia, Switzerland and Turkey, on the condition that they are associated with Horizon Europe, the Digital Europe programme or the Connecting Europe Facility; the European technology platform for high-performance computing (ETP4HPC) association (subject to EU endorsement); DAIRO \u2014 the Data, AI and Robotics Association, formerly known as the Big Data Value Association (BVDA) (subject to endorsement). Governance The governance structure comprises: a governing board, composed of representatives of the EU and participating countries, responsible for strategic policymaking and funding decisions; an industrial and scientific advisory board, with academic and industry representatives as users and technology suppliers, to provide independent advice to the governing board on the strategic research and innovation agenda and on acquiring and operating the supercomputers owned by the joint undertaking. Financial contribution The EU\u2019s financial contribution to the joint undertaking, including European Economic Area (EEA) appropriations, is up to \u20ac3,081,300,000, including \u20ac92,000,000 for administration, on condition that it is matched by the contribution of participating countries, distributed as follows: Horizon Europe: up to \u20ac900,000,000; Digital Europe programme: up to \u20ac1,981,300,000; Connecting Europe Facility: up to \u20ac200,000,000. Private members of the joint undertaking must contribute at least \u20ac900,000,000. Acquisition and ownership of computer equipment The joint undertaking acquires the following elements under the regulation. High-end supercomputers, quantum computers and quantum simulators*, retaining ownership. The EU covers up to 50% of the acquisition costs plus up to 50% of the operating costs. The remaining total cost of ownership is covered by the participating state where the hosting company is established. Industrial-grade EuroHPC supercomputers, retaining ownership. The EU covers up to 35% of the acquisition costs plus up to 35% of the operating costs, the remainder covered by the consortium of private partners. Mid-range supercomputers, jointly with participating countries, with joint ownership. The EU covers up to 35% of the acquisition costs plus up to 35% of the operating costs. The remaining total cost of ownership is covered by the participating state where the hosting company is established. The joint undertaking may launch a call to upgrade the EuroHPC supercomputers it owns or co-owns. The maximum EU contribution to such upgrades may not exceed \u20ac150,000,000 for the period 2021\u20132027. FROM WHEN DOES THE REGULATION APPLY? It has applied since 8 August 2021 and covers the period up to 31 December 2033. BACKGROUND For more information, see: European technology platform for high-performance computing (ETP4HPC) (European Commission) Horizon Europe (European Commission) Digital Europe programme (European Commission) Connecting Europe Facility (European Commission). KEY TERMS Supercomputing. The term generally applied to mean the fastest high-performance systems available at any given time. Supercomputers are used primarily for scientific and engineering work requiring exceedingly high-speed computations. Quantum-computing. The study of how to use phenomena in quantum physics to create new ways of computing. Quantum computers perform calculations based on the probability of an object\u2019s state before it is measured. Quantum simulators. Devices that actively use quantum effects to answer questions about model systems and, through them, real systems. MAIN DOCUMENT Council Regulation (EU) 2021/1173 of 13 July 2021 on establishing the European High Performance Computing Joint Undertaking and repealing Regulation (EU) 2018/1488 (OJ L 256, 19.7.2021, pp. 3\u201351). RELATED DOCUMENTS Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (OJ L 249, 14.7.2021, pp. 38\u201381). Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, pp. 159\u2013706). Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, pp. 1\u201334). Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2014 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1\u201368). Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 The European Green Deal (COM(2019) 640 final, 11.12.2019). Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Three \u2014 Union policies and internal actions \u2014 Title XIX \u2014 Research and technological development and space \u2014 Article 187 (ex Article 171 TEC) (OJ C 202, 7.6.2016, p. 131). last update 29.10.2021"}
{"article": "9.7.2021 EN Official Journal of the European Union L 243/1 REGULATION (EU) 2021/1119 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (\u2018European Climate Law\u2019) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinions of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The existential threat posed by climate change requires enhanced ambition and increased climate action by the Union and the Member States. The Union is committed to stepping up efforts to tackle climate change and to delivering on the implementation of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (the \u2018Paris Agreement\u2019) (4), guided by its principles and on the basis of the best available scientific knowledge, in the context of the long-term temperature goal of the Paris Agreement. (2) The Commission has, in its communication of 11 December 2019 entitled \u2018The European Green Deal\u2019 (the \u2018European Green Deal\u2019), set out a new growth strategy that aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy, where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use. The European Green Deal also aims to protect, conserve and enhance the Union\u2019s natural capital, and protect the health and well-being of citizens from environment-related risks and impacts. At the same time, this transition must be just and inclusive, leaving no one behind. (3) The Intergovernmental Panel on Climate Change (IPCC) provides in its 2018 Special Report on the impacts of global warming of 1,5 \u00b0C above pre-industrial levels and related global greenhouse gas emission pathways, in the context of strengthening the global response to the threat of climate change, sustainable development, and efforts to eradicate poverty, a strong scientific basis for tackling climate change and illustrates the need to rapidly step up climate action and to continue the transition to a climate-neutral economy. That report confirms that greenhouse gas emissions need to be urgently reduced, and that climate change needs to be limited to 1,5 \u00b0C, in particular to reduce the likelihood of extreme weather events and of reaching tipping points. The Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES) has shown in its 2019 Global Assessment Report on Biodiversity and Ecosystem Services a worldwide erosion of biodiversity, with climate change as the third most important driver of biodiversity loss. (4) A fixed long-term objective is crucial to contribute to economic and societal transformation, high-quality jobs, sustainable growth, and the achievement of the United Nations Sustainable Development Goals, as well as to reach in a just, socially balanced, fair and cost-effective manner the long-term temperature goal of the Paris Agreement. (5) It is necessary to address the growing climate-related risks to health, including more frequent and intense heatwaves, wildfires and floods, food and water safety and security threats, and the emergence and spread of infectious diseases. As announced in its communication of 24 February 2021 entitled \u2018Forging a climate-resilient Europe \u2013 the new EU Strategy on Adaptation to Climate Change\u2019, the Commission has launched a European climate and health observatory under the European Climate Adaptation Platform Climate-ADAPT, to better understand, anticipate and minimise the health threats caused by climate change. (6) This Regulation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, in particular Article 37 thereof which seeks to promote the integration into the policies of the Union of a high level of environmental protection and the improvement of the quality of the environment in accordance with the principle of sustainable development. (7) Climate action should be an opportunity for all sectors of the economy in the Union to help secure industry leadership in global innovation. Driven by the Union\u2019s regulatory framework and efforts made by industry, it is possible to decouple economic growth from greenhouse gas emissions. For example, Union greenhouse gas emissions were reduced by 24 % between 1990 and 2019, while the economy grew by 60 % over the same period. Without prejudice to binding legislation and other initiatives adopted at Union level, all sectors of the economy \u2013 including energy, industry, transport, heating and cooling and buildings, agriculture, waste and land use, land-use change and forestry, irrespective of whether those sectors are covered by the system for greenhouse gas emission allowance trading within the Union (\u2018EU ETS\u2019) \u2013 should play a role in contributing to the achievement of climate neutrality within the Union by 2050. In order to enhance involvement of all economic actors, the Commission should facilitate sector-specific climate dialogues and partnerships by bringing together key stakeholders in an inclusive and representative manner, so as to encourage sectors themselves to draw up indicative voluntary roadmaps and to plan their transition towards achieving the Union\u2019s climate-neutrality objective by 2050. Such roadmaps could make a valuable contribution in assisting sectors in planning the necessary investments towards the transition to a climate-neutral economy and could also serve to strengthen sectoral engagement in the pursuit of climate-neutral solutions. Such roadmaps could also complement existing initiatives, including the European Battery Alliance and the European Clean Hydrogen Alliance, which foster industrial collaboration in the transition to climate neutrality. (8) The Paris Agreement sets out a long-term temperature goal in point (a) of Article 2(1) thereof, and aims to strengthen the global response to the threat of climate change by increasing the ability to adapt to the adverse impacts of climate change as set out in point (b) of Article 2(1) thereof and by making finance flows consistent with a pathway towards low greenhouse gas emissions and climate-resilient development as set out in point (c) of Article 2(1) thereof. As the overall framework for the Union\u2019s contribution to the Paris Agreement, this Regulation should ensure that both the Union and the Member States contribute to the global response to climate change as referred to in the Paris Agreement. (9) The Union\u2019s and Member States\u2019 climate action aims to protect people and the planet, welfare, prosperity, the economy, health, food systems, the integrity of eco-systems and biodiversity against the threat of climate change, in the context of the United Nations 2030 agenda for sustainable development and in pursuit of the objectives of the Paris Agreement, and to maximise prosperity within the planetary boundaries and to increase resilience and reduce vulnerability of society to climate change. In light of this, the Union\u2019s and Member States\u2019 actions should be guided by the precautionary and \u2018polluter pays\u2019 principles established in the Treaty on the Functioning of the European Union, and should also take into account the \u2018energy efficiency first\u2019 principle of the Energy Union and the \u2018do no harm\u2019 principle of the European Green Deal. (10) Achieving climate neutrality should require a contribution from all economic sectors for which emissions or removals of greenhouse gases are regulated in Union law. (11) In light of the importance of energy production and consumption for the level of greenhouse gas emissions, it is essential to ensure a transition to a safe, sustainable, affordable and secure energy system relying on the deployment of renewables, a well-functioning internal energy market and the improvement of energy efficiency, while reducing energy poverty. Digital transformation, technological innovation, and research and development are also important drivers for achieving the climate-neutrality objective. (12) The Union has in place a regulatory framework to achieve the 2030 greenhouse gas emission reduction target agreed in 2014, before the entry into force of the Paris Agreement. The legislation implementing that target consists, inter alia, of Directive 2003/87/EC of the European Parliament and of the Council (5), which establishes the EU ETS, Regulation (EU) 2018/842 of the European Parliament and of the Council (6), which introduced national targets for reduction of greenhouse gas emissions by 2030, and Regulation (EU) 2018/841 of the European Parliament and of the Council (7), which requires Member States to balance greenhouse gas emissions and removals from land use, land use change and forestry. (13) The EU ETS is a cornerstone of the Union\u2019s climate policy and constitutes its key tool for reducing greenhouse gas emissions in a cost-effective way. (14) The Commission has, in its communication of 28 November 2018 entitled \u2018A Clean Planet for all \u2013 A European strategic long-term vision for a prosperous, modern, competitive and climate-neutral economy\u2019, presented a vision for achieving net-zero greenhouse gas emissions in the Union by 2050 through a socially-fair and cost-efficient transition. (15) Through the \u2018Clean Energy for All Europeans\u2019 package of 30 November 2016 the Union has been pursuing an ambitious decarbonisation agenda, in particular by constructing a robust Energy Union, which includes the 2030 goals for energy efficiency and deployment of renewable energy in Directives 2012/27/EU (8) and (EU) 2018/2001 (9) of the European Parliament and of the Council, and by reinforcing relevant legislation, including Directive 2010/31/EU of the European Parliament and of the Council (10). (16) The Union is a global leader in the transition towards climate neutrality, and it is determined to help raise global ambition and to strengthen the global response to climate change, using all tools at its disposal, including climate diplomacy. (17) The Union should continue its climate action and international climate leadership after 2050, in order to protect people and the planet against the threat of dangerous climate change, in pursuit of the long-term temperature goal set out in the Paris Agreement and following the scientific assessments of the IPCC, IPBES, and the European Scientific Advisory Board on Climate Change, as well as the assessments of other international bodies. (18) The risk of carbon leakage remains in respect of those international partners that do not share the same standards of climate protection as those of the Union. The Commission therefore intends to propose a carbon border adjustment mechanism for selected sectors, to reduce such risks in a way which is compatible with the rules of the World Trade Organization. Furthermore, it is important to maintain effective policy incentives in support of technological solutions and innovations which enable the transition to a competitive climate-neutral Union economy, while providing investment certainty. (19) The European Parliament called, in its resolution of 15 January 2020 on the European Green Deal, for the necessary transition to a climate-neutral society by 2050 at the latest and for this to be made into a European success story and has, in its resolution of 28 November 2019 on the climate and environment emergency, declared a climate and environment emergency. It has also repeatedly called on the Union to increase its 2030 climate target, and for that increased target to be part of this Regulation. The European Council, in its conclusions of 12 December 2019, has agreed on the objective of achieving a climate-neutral Union by 2050, in line with the objectives of the Paris Agreement, while also recognising that it is necessary to put in place an enabling framework that benefits all Member States and encompasses adequate instruments, incentives, support and investments to ensure a cost-efficient, just, as well as socially balanced and fair transition, taking into account different national circumstances in terms of starting points. It also noted that the transition will require significant public and private investment. On 6 March 2020, the Union submitted its long-term low greenhouse gas emission development strategy and, on 17 December 2020, its nationally determined contribution, to the United Nations Framework Convention on Climate Change (UNFCCC), following their approval by the Council. (20) The Union should aim to achieve a balance between anthropogenic economy-wide emissions by sources and removals by sinks of greenhouse gases domestically within the Union by 2050 and, as appropriate, achieve negative emissions thereafter. That objective should encompass Union-wide greenhouse gas emissions and removals regulated in Union law. It should be possible to address such emissions and removals in the context of the review of the relevant climate and energy legislation. Sinks include natural and technological solutions, as reported in the Union\u2019s greenhouse gas inventories to the UNFCCC. Solutions that are based on carbon capture and storage (CCS) and carbon capture and use (CCU) technologies can play a role in decarbonisation, especially for the mitigation of process emissions in industry, for the Member States that choose this technology. The Union-wide 2050 climate-neutrality objective should be pursued by all Member States collectively, and Member States, the European Parliament, the Council and the Commission should take the necessary measures to enable its achievement. Measures at Union level will constitute an important part of the measures needed to achieve the objective. (21) In its conclusions of 8 and 9 March 2007 and of 23 and 24 October 2014, the European Council endorsed the Union\u2019s greenhouse gas emission reduction target for 2020 and the 2030 climate and energy policy framework, respectively. The provisions of this Regulation on the determination of the Union\u2019s climate target for 2040 are without prejudice to the role of the European Council, as set out in the Treaties, in defining the Union\u2019s general political direction and priorities for the development of the Union\u2019s climate policy. (22) Carbon sinks play an essential role in the transition to climate neutrality in the Union, and in particular the agriculture, forestry and land use sectors make an important contribution in that context. As announced in its communication of 20 May 2020 entitled \u2018A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system\u2019, the Commission will promote a new green business model to reward land managers for greenhouse gas emission reductions and carbon removals in the upcoming carbon farming initiative. Furthermore, in its communication of 11 March 2020 entitled \u2018A new Circular Economy Action Plan for a cleaner and more competitive Europe\u2019, the Commission has committed itself to developing a regulatory framework for certification of carbon removals based on robust and transparent carbon accounting to monitor and verify the authenticity of carbon removals, while ensuring that there are no negative impacts on the environment, in particular biodiversity, on public health or on social or economic objectives. (23) The restoration of ecosystems would assist in maintaining, managing and enhancing natural sinks and promote biodiversity while fighting climate change. Furthermore, the \u2018triple role\u2019 of forests, namely, as carbon sinks, storage and substitution, contributes to the reduction of greenhouse gases in the atmosphere, while ensuring that forests continue to grow and provide many other services. (24) Scientific expertise and the best available, up-to-date evidence, together with information on climate change that is both factual and transparent, are imperative and need to underpin the Union\u2019s climate action and efforts to reach climate neutrality by 2050. A European Scientific Advisory Board on Climate Change (the \u2018Advisory Board\u2019) should be established to serve as a point of reference on scientific knowledge relating to climate change by virtue of its independence and scientific and technical expertise. The Advisory Board should complement the work of the European Environment Agency (EEA) while acting independently in discharging its tasks. Its mission should avoid any overlap with the mission of the IPCC at international level. Regulation (EC) No 401/2009 of the European Parliament and of the Council (11) should therefore be amended in order to establish the Advisory Board. National climate advisory bodies can play an important role in, inter alia, providing expert scientific advice on climate policy to the relevant national authorities as prescribed by the Member State concerned in those Member States where they exist. Therefore, Member States that have not already done so are invited to establish a national climate advisory body. (25) The transition to climate neutrality requires changes across the entire policy spectrum and a collective effort of all sectors of the economy and society, as highlighted in the European Green Deal. The European Council, in its conclusions of 12 December 2019, stated that all relevant Union legislation and policies need to be consistent with, and contribute to, the fulfilment of the climate-neutrality objective while respecting a level playing field, and invited the Commission to examine whether this requires an adjustment of the existing rules. (26) As announced in the European Green Deal, the Commission assessed the Union\u2019s 2030 target for greenhouse gas emission reduction, in its communication of 17 September 2020 entitled \u2018Stepping up Europe\u2019s 2030 climate ambition \u2013 Investing in a climate-neutral future for the benefit of our people\u2019. The Commission did so on the basis of a comprehensive impact assessment and taking into account its analysis of the integrated national energy and climate plans submitted to it in accordance with Regulation (EU) 2018/1999 of the European Parliament and of the Council (12). In light of the 2050 climate-neutrality objective, by 2030 greenhouse gas emissions should be reduced and removals enhanced, so that net greenhouse gas emissions, that is emissions after the deduction of removals, are reduced economy-wide and domestically by at least 55 % by 2030 compared to 1990 levels. The European Council endorsed that target in its conclusions of 10 and 11 December 2020. It also provided initial guidance on its implementation. That new Union 2030 climate target is a subsequent target for the purposes of point (11) of Article 2 of Regulation (EU) 2018/1999, and therefore replaces the 2030 Union-wide target for greenhouse gas emissions set out in that point. In addition, the Commission should, by 30 June 2021, assess how the relevant Union legislation implementing the Union 2030 climate target would need to be amended in order to achieve such net emission reductions. In view of this, the Commission has announced a revision of the relevant climate and energy legislation which will be adopted in a package covering, inter alia, renewables, energy efficiency, land use, energy taxation, CO2 emission performance standards for light-duty vehicles, effort sharing and the EU ETS. The Commission intends to assess the impacts of the introduction of additional Union measures that could complement existing measures, such as market-based measures that include a strong solidarity mechanism. (27) According to Commission assessments, the existing commitments under Article 4 of Regulation (EU) 2018/841 result in a net carbon sink of 225 million tonnes of CO2 equivalent in 2030. In order to ensure that sufficient mitigation efforts are deployed until 2030, it is appropriate to limit the contribution of net removals to the Union 2030 climate target to that level. This is without prejudice to the review of the relevant Union legislation in order to enable the achievement of the target. (28) Expenditure under the Union budget and the European Union Recovery Instrument established by Council Regulation (EU) 2020/2094 (13) contributes to climate objectives, by dedicating at least 30 % of the total amount of the expenditure to supporting climate objectives, on the basis of an effective methodology and in accordance with sectoral legislation. (29) In light of the objective of achieving climate neutrality by 2050 and in view of the international commitments under the Paris Agreement, continued efforts are necessary to ensure the phasing out of energy subsidies which are incompatible with that objective, in particular for fossil fuels, without impacting efforts to reduce energy poverty. (30) In order to provide predictability and confidence for all economic actors, including businesses, workers, investors and consumers, to ensure a gradual reduction of greenhouse gas emissions over time and that the transition towards climate neutrality is irreversible, the Commission should propose a Union intermediate climate target for 2040, as appropriate, at the latest within six months of the first global stocktake carried out under the Paris Agreement. The Commission can make proposals to revise the intermediate target, taking into account the findings of the assessments of Union progress and measures and of national measures as well as the outcomes of the global stocktake and of international developments, including on common time frames for nationally determined contributions. As a tool to increase the transparency and accountability of the Union\u2019s climate policies, the Commission should, when making its legislative proposal for the Union 2040 climate target, publish the projected indicative Union greenhouse gas budget for the 2030-2050 period, defined as the indicative total volume of net greenhouse gas emissions that are expected to be emitted in that period without putting at risk the Union\u2019s commitments under the Paris Agreement, as well as the methodology underlying that indicative budget. (31) Adaptation is a key component of the long-term global response to climate change. The adverse effects of climate change can potentially exceed the adaptive capacities of Member States. Therefore, Member States and the Union should enhance their adaptive capacity, strengthen resilience and reduce vulnerability to climate change, as provided for in Article 7 of the Paris Agreement, as well as maximise the co-benefits with other policies and legislation. The Commission should adopt a Union strategy on adaptation to climate change in line with the Paris Agreement. Member States should adopt comprehensive national adaptation strategies and plans based on robust climate change and vulnerability analyses, progress assessments and indicators, and guided by the best available and most recent scientific evidence. The Union should seek to create a favourable regulatory environment for national policies and measures put in place by Member States to adapt to climate change. Improving climate resilience and adaptive capacities to climate change requires shared efforts by all sectors of the economy and society, as well as policy coherence and consistency in all relevant legislation and policies. (32) Ecosystems, people and economies in all regions of the Union will face major impacts from climate change, such as extreme heat, floods, droughts, water scarcity, sea level rise, thawing glaciers, forest fires, windthrows and agricultural losses. Recent extreme events have already had substantial impacts on ecosystems, affecting carbon sequestration and storage capacities of forest and agricultural land. Enhancing adaptive capacities and resilience, taking into account the United Nations Sustainable Development Goals, help to minimise climate change impacts, to address unavoidable impacts in a socially balanced manner and to improve living conditions in impacted areas. Preparing early for such impacts is cost-effective and can also bring considerable co-benefits for ecosystems, health and the economy. Nature-based solutions, in particular, can benefit climate change mitigation, adaptation and biodiversity protection. (33) The relevant programmes established under the Multiannual Financial Framework provide for the screening of projects to ensure that such projects are resilient to the potential adverse impacts of climate change through a climate vulnerability and risk assessment, including through relevant adaptation measures, and that they integrate the costs of greenhouse gas emissions and the positive effects of climate mitigation measures in the cost-benefit analysis. This contributes to the integration of climate change-related risks as well as climate change vulnerability and adaptation assessments into investment and planning decisions under the Union budget. (34) In taking the relevant measures at Union and national level to achieve the climate-neutrality objective, Member States and the European Parliament, the Council and the Commission should, inter alia, take into account: the contribution of the transition to climate neutrality to public health, the quality of the environment, the well-being of citizens, the prosperity of society, employment and the competitiveness of the economy; the energy transition, strengthened energy security and the tackling of energy poverty; food security and affordability; the development of sustainable and smart mobility and transport systems; fairness and solidarity across and within Member States, in light of their economic capability, national circumstances, such as the specificities of islands, and the need for convergence over time; the need to make the transition just and socially fair through appropriate education and training programmes; best available and most recent scientific evidence, in particular the findings reported by the IPCC; the need to integrate climate change related risks into investment and planning decisions; cost-effectiveness and technological neutrality in achieving greenhouse gas emission reductions and removals and increasing resilience; and progression over time in environmental integrity and level of ambition. (35) As indicated in the European Green Deal, the Commission adopted on 9 December 2020 a communication entitled \u2018Sustainable and Smart Mobility Strategy \u2013 putting European transport on track for the future\u2019. The strategy sets out a roadmap for a sustainable and smart future for European transport, with an action plan towards an objective to deliver a 90 % reduction in emissions from the transport sector by 2050. (36) To ensure that the Union and the Member States remain on track to achieve the climate-neutrality objective and progress on adaptation, the Commission should regularly assess progress, building upon information as set out in this Regulation, including information submitted and reported under Regulation (EU) 2018/1999. In order to allow for a timely preparation for the global stocktake referred to in Article 14 of the Paris Agreement, the conclusions of this assessment should be published by 30 September every five years, starting in 2023. This implies that the reports under Article 29(5) and Article 35 of that Regulation and, in the applicable years, the related reports under Article 29(1) and Article 32 of that Regulation should be submitted to the European Parliament and to the Council at the same time as the conclusions of that assessment. In the event that the collective progress made by Member States towards the achievement of the climate-neutrality objective or on adaptation is insufficient or that Union measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience or reduce vulnerability, the Commission should take the necessary measures in accordance with the Treaties. The Commission should also regularly assess relevant national measures, and issue recommendations where it finds that a Member State\u2019s measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience and reduce vulnerability to climate change. (37) The Commission should ensure a robust and objective assessment based on the most up-to-date scientific, technical and socioeconomic findings, and representative of a broad range of independent expertise, and base its assessment on relevant information including information submitted and reported by Member States, reports of the EEA, of the Advisory Board and of the Commission\u2019s Joint Research Centre, the best available and most recent scientific evidence, including the latest reports of the IPCC, IPBES and other international bodies, as well as the Earth observation data provided by the European Earth Observation Programme Copernicus. The Commission should further base its assessments on an indicative, linear trajectory linking the Union\u2019s climate targets for 2030 and 2040, when adopted, with the Union\u2019s climate-neutrality objective and serving as an indicative tool to estimate and evaluate collective progress towards the achievement of the Union\u2019s climate-neutrality objective. The indicative, linear trajectory is without prejudice to any decision to determine a Union climate target for 2040. Given that the Commission has committed itself to exploring how the EU taxonomy can be used in the context of the European Green Deal by the public sector, this should include information on environmentally sustainable investment, by the Union or by Member States, consistent with Regulation (EU) 2020/852 of the European Parliament and of the Council (14) when such information becomes available. The Commission should use European and global statistics and data where available and seek expert scrutiny. The EEA should assist the Commission, as appropriate and in accordance with its annual work programme. (38) As citizens and communities have a powerful role to play in driving the transformation towards climate neutrality forward, strong public and social engagement on climate action should be both encouraged and facilitated at all levels, including at national, regional and local level in an inclusive and accessible process. The Commission should therefore engage with all parts of society, including stakeholders representing different sectors of the economy, to enable and empower them to take action towards a climate-neutral and climate-resilient society, including through the European Climate Pact. (39) In line with the Commission\u2019s commitment to the principles on Better Law-Making, coherence of the Union instruments as regards greenhouse gas emission reductions should be sought. The system of measuring the progress towards the achievement of the climate-neutrality objective as well as the consistency of measures taken with that objective should build upon and be consistent with the governance framework laid down in Regulation (EU) 2018/1999, taking into account all five dimensions of the Energy Union. In particular, the system of reporting on a regular basis and the sequencing of the Commission\u2019s assessment and actions on the basis of the reporting should be aligned to the requirements to submit information and provide reports by Member States laid down in Regulation (EU) 2018/1999. Regulation (EU) 2018/1999 should therefore be amended in order to include the climate-neutrality objective in the relevant provisions. (40) Climate change is by definition a trans-boundary challenge and coordinated action at Union level is needed to effectively supplement and reinforce national policies. Since the objective of this Regulation, namely to achieve climate neutrality in the Union by 2050, cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope This Regulation establishes a framework for the irreversible and gradual reduction of anthropogenic greenhouse gas emissions by sources and enhancement of removals by sinks regulated in Union law. This Regulation sets out a binding objective of climate neutrality in the Union by 2050 in pursuit of the long-term temperature goal set out in point (a) of Article 2(1) of the Paris Agreement, and provides a framework for achieving progress in pursuit of the global adaptation goal established in Article 7 of the Paris Agreement. This Regulation also sets out a binding Union target of a net domestic reduction in greenhouse gas emissions for 2030. This Regulation applies to anthropogenic emissions by sources and removals by sinks of the greenhouse gases listed in Part 2 of Annex V to Regulation (EU) 2018/1999. Article 2 Climate-neutrality objective 1. Union-wide greenhouse gas emissions and removals regulated in Union law shall be balanced within the Union at the latest by 2050, thus reducing emissions to net zero by that date, and the Union shall aim to achieve negative emissions thereafter. 2. The relevant Union institutions and the Member States shall take the necessary measures at Union and national level, respectively, to enable the collective achievement of the climate-neutrality objective set out in paragraph 1, taking into account the importance of promoting both fairness and solidarity among Member States and cost-effectiveness in achieving this objective. Article 3 Scientific advice on climate change 1. The European Scientific Advisory Board on Climate Change established under Article 10a of Regulation (EC) No 401/2009 (the \u2018Advisory Board\u2019) shall serve as a point of reference for the Union on scientific knowledge relating to climate change by virtue of its independence and scientific and technical expertise. 2. The tasks of the Advisory Board shall include: (a) considering the latest scientific findings of the IPCC reports and scientific climate data, in particular with regard to information relevant to the Union; (b) providing scientific advice and issuing reports on existing and proposed Union measures, climate targets and indicative greenhouse gas budgets, and their coherence with the objectives of this Regulation and the Union\u2019s international commitments under the Paris Agreement; (c) contributing to the exchange of independent scientific knowledge in the field of modelling, monitoring, promising research and innovation which contribute to reducing emissions or increasing removals; (d) identifying actions and opportunities needed to successfully achieve the Union climate targets; (e) raising awareness on climate change and its impacts, as well as stimulating dialogue and cooperation between scientific bodies within the Union, complementing existing work and efforts. 3. The Advisory Board shall be guided in its work by the best available and most recent scientific evidence, including the latest reports of the IPCC, IPBES and other international bodies. It shall follow a fully transparent process and make its reports publicly available. It may take into account, where available, the work of the national climate advisory bodies referred to in paragraph 4. 4. In the context of enhancing the role of science in the field of climate policy, each Member State is invited to establish a national climate advisory body, responsible for providing expert scientific advice on climate policy to the relevant national authorities as prescribed by the Member State concerned. Where a Member State decides to establish such an advisory body, it shall inform the EEA thereof. Article 4 Intermediate Union climate targets 1. In order to reach the climate-neutrality objective set out in Article 2(1), the binding Union 2030 climate target shall be a domestic reduction of net greenhouse gas emissions (emissions after deduction of removals) by at least 55 % compared to 1990 levels by 2030. When implementing the target referred to in the first subparagraph, the relevant Union institutions and the Member States shall prioritise swift and predictable emission reductions and, at the same time, enhance removals by natural sinks. In order to ensure that sufficient mitigation efforts are deployed up to 2030, for the purpose of this Regulation and without prejudice to the review of Union legislation referred to in paragraph 2, the contribution of net removals to the Union 2030 climate target shall be limited to 225 million tonnes of CO2 equivalent. In order to enhance the Union\u2019s carbon sink in line with the objective of achieving climate neutrality by 2050, the Union shall aim to achieve a higher volume of its net carbon sink in 2030. 2. By 30 June 2021, the Commission shall review relevant Union legislation in order to enable the achievement of the target set out in paragraph 1 of this Article and the climate-neutrality objective set out in Article 2(1) and consider taking the necessary measures, including the adoption of legislative proposals, in accordance with the Treaties. Within the framework of the review referred to in the first subparagraph and future reviews, the Commission shall assess in particular the availability under Union law of adequate instruments and incentives to mobilise the investments needed, and propose measures as necessary. From the adoption of the legislative proposals by the Commission, it shall monitor the legislative procedures for the different proposals and may report to the European Parliament and to the Council on whether the foreseen outcome of those legislative procedures, considered together, would achieve the target set out in paragraph 1. If the foreseen outcome would not deliver a result in line with the target set out in paragraph 1, the Commission may take the necessary measures, including the adoption of legislative proposals, in accordance with the Treaties. 3. With a view to achieving the climate-neutrality objective set out in Article 2(1) of this Regulation, a Union-wide climate target for 2040 shall be set. To that end, at the latest within six months of the first global stocktake referred to in Article 14 of the Paris Agreement, the Commission shall make a legislative proposal, as appropriate, based on a detailed impact assessment, to amend this Regulation to include the Union 2040 climate target, taking into account the conclusions of the assessments referred to in Articles 6 and 7 of this Regulation and the outcomes of the global stocktake. 4. When making its legislative proposal for the Union 2040 climate target as referred to in paragraph 3, the Commission shall, at the same time, publish in a separate report the projected indicative Union greenhouse gas budget for the 2030-2050 period, defined as the indicative total volume of net greenhouse gas emissions (expressed as CO2 equivalent and providing separate information on emissions and removals) that are expected to be emitted in that period without putting at risk the Union\u2019s commitments under the Paris Agreement. The projected indicative Union greenhouse gas budget shall be based on the best available science, take into account the advice of the Advisory Board as well as, where adopted, the relevant Union legislation implementing the Union 2030 climate target. The Commission shall also publish the methodology underlying the projected indicative Union greenhouse gas budget. 5. When proposing the Union 2040 climate target in accordance with paragraph 3, the Commission shall consider the following: (a) the best available and most recent scientific evidence, including the latest reports of the IPCC and the Advisory Board; (b) the social, economic and environmental impacts, including the costs of inaction; (c) the need to ensure a just and socially fair transition for all; (d) cost-effectiveness and economic efficiency; (e) competiveness of the Union\u2019s economy, in particular small and medium-sized enterprises and sectors most exposed to carbon leakage; (f) best available cost-effective, safe and scalable technologies; (g) energy efficiency and the \u2018energy efficiency first\u2019 principle, energy affordability and security of supply; (h) fairness and solidarity between and within Member States; (i) the need to ensure environmental effectiveness and progression over time; (j) the need to maintain, manage and enhance natural sinks in the long term and protect and restore biodiversity; (k) investment needs and opportunities; (l) international developments and efforts undertaken to achieve the long-term objectives of the Paris Agreement and the ultimate objective of the UNFCCC; (m) existing information on the projected indicative Union greenhouse gas budget for the 2030-2050 period referred to in paragraph 4. 6. Within six months of the second global stocktake referred to in Article 14 of the Paris Agreement, the Commission may propose to revise the Union 2040 climate target in accordance with Article 11 of this Regulation. 7. The provisions of this Article shall be kept under review in light of international developments and efforts undertaken to achieve the long-term objectives of the Paris Agreement, including with regard to the outcomes of international discussions on common time frames for nationally determined contributions. Article 5 Adaptation to climate change 1. The relevant Union institutions and the Member States shall ensure continuous progress in enhancing adaptive capacity, strengthening resilience and reducing vulnerability to climate change in accordance with Article 7 of the Paris Agreement. 2. The Commission shall adopt a Union strategy on adaptation to climate change in line with the Paris Agreement and shall regularly review it in the context of the review provided for in point (b) of Article 6(2) of this Regulation. 3. The relevant Union institutions and the Member States shall also ensure that policies on adaptation in the Union and in Member States are coherent, mutually supportive, provide co-benefits for sectoral policies, and work towards better integration of adaptation to climate change in a consistent manner in all policy areas, including relevant socioeconomic and environmental policies and actions, where appropriate, as well as in the Union\u2019s external action. They shall focus, in particular, on the most vulnerable and impacted populations and sectors, and identify shortcomings in this regard in consultation with civil society. 4. Member States shall adopt and implement national adaptation strategies and plans, taking into consideration the Union strategy on adaptation to climate change referred to in paragraph 2 of this Article and based on robust climate change and vulnerability analyses, progress assessments and indicators, and guided by the best available and most recent scientific evidence. In their national adaptation strategies, Member States shall take into account the particular vulnerability of the relevant sectors, inter alia, agriculture, and of water and food systems, as well as food security, and promote nature-based solutions and ecosystem-based adaptation. Member States shall regularly update the strategies and include the related updated information in the reports to be submitted under Article 19(1) of Regulation (EU) 2018/1999. 5. By 30 July 2022, the Commission shall adopt guidelines setting out common principles and practices for the identification, classification and prudential management of material physical climate risks when planning, developing, executing and monitoring projects and programmes for projects. Article 6 Assessment of Union progress and measures 1. By 30 September 2023, and every five years thereafter, the Commission shall assess, together with the assessment provided for under Article 29(5) of Regulation (EU) 2018/1999: (a) the collective progress made by all Member States towards the achievement of the climate-neutrality objective set out in Article 2(1) of this Regulation; (b) the collective progress made by all Member States on adaptation as referred to in Article 5 of this Regulation. The Commission shall submit the conclusions of that assessment, together with the State of the Energy Union report prepared in the respective calendar year in accordance with Article 35 of Regulation (EU) 2018/1999, to the European Parliament and to the Council. 2. By 30 September 2023, and every five years thereafter, the Commission shall review: (a) the consistency of Union measures with the climate-neutrality objective set out in Article 2(1); (b) the consistency of Union measures with ensuring progress on adaptation as referred to in Article 5. 3. Where, based on the assessments referred to in paragraphs 1 and 2 of this Article, the Commission finds that Union measures are inconsistent with the climate-neutrality objective set out in Article 2(1) or inconsistent with ensuring progress on adaptation as referred to in Article 5, or that the progress towards that climate-neutrality objective or on adaptation as referred to in Article 5 is insufficient, it shall take the necessary measures in accordance with the Treaties. 4. The Commission shall assess the consistency of any draft measure or legislative proposal, including budgetary proposals, with the climate-neutrality objective set out in Article 2(1) and the Union 2030 and 2040 climate targets before adoption, and include that assessment in any impact assessment accompanying these measures or proposals, and make the result of that assessment publicly available at the time of adoption. The Commission shall also assess whether those draft measures or legislative proposals, including budgetary proposals, are consistent with ensuring progress on adaptation as referred to in Article 5. When making its draft measures and legislative proposals, the Commission shall endeavour to align them with the objectives of this Regulation. In any case of non-alignment, the Commission shall provide the reasons as part of the consistency assessment referred to in this paragraph. Article 7 Assessment of national measures 1. By 30 September 2023, and every five years thereafter, the Commission shall assess: (a) the consistency of national measures identified, on the basis of the integrated national energy and climate plans, national long-term strategies and the biennial progress reports submitted in accordance with Regulation (EU) 2018/1999, as relevant for the achievement of the climate-neutrality objective set out in Article 2(1) of this Regulation with that objective; (b) the consistency of relevant national measures with ensuring progress on adaptation as referred to in Article 5, taking into account the national adaptation strategies referred to in Article 5(4). The Commission shall submit the conclusions of that assessment, together with the State of the Energy Union report prepared in the respective calendar year in accordance with Article 35 of Regulation (EU) 2018/1999, to the European Parliament and to the Council. 2. Where the Commission finds, after due consideration of the collective progress assessed in accordance with Article 6(1), that a Member State\u2019s measures are inconsistent with the climate-neutrality objective set out in Article 2(1) or inconsistent with ensuring progress on adaptation as referred to in Article 5, it may issue recommendations to that Member State. The Commission shall make such recommendations publicly available. 3. Where recommendations are issued in accordance with paragraph 2, the following principles shall apply: (a) the Member State concerned shall, within six months of receipt of the recommendations, notify the Commission on how it intends to take due account of the recommendations in a spirit of solidarity between Member States and the Union and between Member States; (b) after the submission of the notification referred to in point (a) of this paragraph, the Member State concerned shall set out, in its following integrated national energy and climate progress report submitted in accordance with Article 17 of Regulation (EU) 2018/1999, in the year following the year in which the recommendations were issued, how it has taken due account of the recommendations; if the Member State concerned decides not to address the recommendations or a substantial part thereof, that Member State shall provide the Commission its reasoning; (c) the recommendations shall be complementary to the latest country-specific recommendations issued in the context of the European Semester. Article 8 Common provisions on Commission assessment 1. The Commission shall base its first and second assessments referred to in Articles 6 and 7 on an indicative, linear trajectory which sets out the pathway for the reduction of net emissions at Union level and which links the Union 2030 climate target referred to in Article 4(1), the Union 2040 climate target, when adopted, and the climate-neutrality objective set out in Article 2(1). 2. Following the first and second assessments referred to in paragraph 1, the Commission shall base any subsequent assessment on an indicative, linear trajectory linking the Union 2040 climate target, when adopted, and the climate-neutrality objective set out in Article 2(1). 3. In addition to the national measures referred to in point (a) of Article 7(1), the Commission shall base its assessments referred to in Articles 6 and 7 on at least the following: (a) information submitted and reported under Regulation (EU) 2018/1999; (b) reports of the EEA, the Advisory Board and the Commission\u2019s Joint Research Centre; (c) European and global statistics and data, including statistics and data from the European Earth Observation Programme Copernicus, data on reported and projected losses from adverse climate impacts and estimates on the costs of inaction or delayed action, where available; (d) the best available and most recent scientific evidence, including the latest reports of the IPCC, IPBES and other international bodies; and (e) any supplementary information on environmentally sustainable investment by the Union or by Member States, including, when available, investment consistent with Regulation (EU) 2020/852. 4. The EEA shall assist the Commission in the preparation of the assessments referred to in Articles 6 and 7, in accordance with its annual work programme. Article 9 Public participation 1. The Commission shall engage with all parts of society to enable and empower them to take action towards a just and socially fair transition to a climate-neutral and climate-resilient society. The Commission shall facilitate an inclusive and accessible process at all levels, including at national, regional and local level and with social partners, academia, the business community, citizens and civil society, for the exchange of best practice and to identify actions to contribute to the achievement of the objectives of this Regulation. The Commission may also draw on the public consultations and on the multilevel climate and energy dialogues as set up by Member States in accordance with Articles 10 and 11 of Regulation (EU) 2018/1999. 2. The Commission shall use all appropriate instruments, including the European Climate Pact, to engage citizens, social partners and stakeholders, and foster dialogue and the diffusion of science-based information about climate change and its social and gender equality aspects. Article 10 Sectoral roadmaps The Commission shall engage with sectors of the economy within the Union that choose to prepare indicative voluntary roadmaps towards achieving the climate-neutrality objective set out in Article 2(1). The Commission shall monitor the development of such roadmaps. Its engagement shall involve the facilitation of dialogue at Union level, and the sharing of best practice among relevant stakeholders. Article 11 Review Within six months of each global stocktake referred to in Article 14 of the Paris Agreement, the Commission shall submit a report to the European Parliament and to the Council, together with the conclusions of the assessments referred to in Articles 6 and 7 of this Regulation, on the operation of this Regulation, taking into account: (a) the best available and most recent scientific evidence, including the latest reports of the IPCC and the Advisory Board; (b) international developments and efforts undertaken to achieve the long-term objectives of the Paris Agreement. The Commission\u2019s report may be accompanied, where appropriate, by legislative proposals to amend this Regulation. Article 12 Amendments to Regulation (EC) No 401/2009 Regulation (EC) No 401/2009 is amended as follows: (1) the following article is inserted: \u2018Article 10a 1. A European Scientific Advisory Board on Climate Change (the \u201cAdvisory Board\u201d) is hereby established. 2. The Advisory Board shall be composed of 15 senior scientific experts covering a broad range of relevant disciplines. Members of the Advisory Board shall meet the criteria set out in paragraph 3. No more than two members of the Advisory Board shall hold the nationality of the same Member State. The independence of the members of the Advisory Board shall be beyond doubt. 3. The Management Board shall designate the members of the Advisory Board for a term of four years, which shall be renewable once, following an open, fair and transparent selection procedure. In its selection of the members of the Advisory Board, the Management Board shall seek to ensure a varied disciplinary and sectoral expertise, as well as gender and geographical balance. The selection shall be based on the following criteria: (a) scientific excellence; (b) experience in carrying out scientific assessments and providing scientific advice in the fields of expertise; (c) broad expertise in the field of climate and environment sciences or other scientific fields relevant for the achievement of the Union\u2019s climate objectives; (d) professional experience in an inter-disciplinary environment in an international context. 4. The members of the Advisory Board shall be appointed in a personal capacity and shall give their positions completely independently of the Member States and the Union institutions. The Advisory Board shall elect its chairperson from among its members for a period of four years and it shall adopt its rules of procedure. 5. The Advisory Board shall complement the work of the Agency while acting independently in discharging its tasks. The Advisory Board shall establish its annual work programme independently, and when doing so it shall consult the Management Board. The chairperson of the Advisory Board shall inform the Management Board and the Executive Director of that programme and its implementation.\u2019; (2) in Article 11, the following paragraph is added: \u20185. The Agency\u2019s budget shall also include the expenditure relating to the Advisory Board.\u2019. Article 13 Amendments to Regulation (EU) 2018/1999 Regulation (EU) 2018/1999 is amended as follows: (1) in Article 1(1), point (a) is replaced by the following: \u2018(a) implement strategies and measures designed to meet the objectives and targets of the Energy Union and the long-term Union greenhouse gas emissions commitments consistent with the Paris Agreement, in particular the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119 of the European Parliament and of the Council (*1), and, for the first ten-year period, from 2021 to 2030, in particular the Union\u2019s 2030 targets for energy and climate; (*1) Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (\u201cEuropean Climate Law\u201d) (OJ L 243, 9.7.2021, p. 1).\u2019;\" (2) in Article 2, point (7) is replaced by the following: \u2018(7) \u201cprojections\u201d means forecasts of anthropogenic greenhouse gas emissions by sources and removals by sinks or developments of the energy system, including at least quantitative estimates for a sequence of six future years ending with 0 or 5, immediately following the reporting year;\u2019; (3) in Article 3(2), point (f) is replaced by the following: \u2018(f) an assessment of the impacts of the planned policies and measures to meet the objectives referred to in point (b) of this paragraph, including their consistency with the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119, the long-term greenhouse gas emission reduction objectives under the Paris Agreement and the long-term strategies as referred to in Article 15 of this Regulation;\u2019; (4) in Article 8(2), the following point is added: \u2018(e) the manner in which existing policies and measures and planned policies and measures contribute to the achievement of the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119.\u2019; (5) Article 11 is replaced by the following: \u2018Article 11 Multilevel climate and energy dialogue Each Member State shall establish a multilevel climate and energy dialogue pursuant to national rules, in which local authorities, civil society organisations, business community, investors and other relevant stakeholders and the general public are able actively to engage and discuss the achievement of the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119 and the different scenarios envisaged for energy and climate policies, including for the long term, and review progress, unless it already has a structure which serves the same purpose. Integrated national energy and climate plans may be discussed within the framework of such a dialogue.\u2019; (6) Article 15 is amended as follows: (a) paragraph 1 is replaced by the following: \u20181. By 1 January 2020, and subsequently by 1 January 2029 and every 10 years thereafter, each Member State shall prepare and submit to the Commission its long-term strategy with a 30-year perspective and consistent with the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119. Member States should, where necessary, update those strategies every five years.\u2019; (b) in paragraph 3, point (c) is replaced by the following: \u2018(c) achieving long-term greenhouse gas emission reductions and enhancements of removals by sinks in all sectors in accordance with the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119, in the context of necessary greenhouse gas emission reductions and enhancements of removals by sinks according to the Intergovernmental Panel on Climate Change (IPCC) to reduce the Union\u2019s greenhouse gas emissions in a cost-effective manner and enhance removals by sinks in pursuit of the long-term temperature goal in the Paris Agreement so as to achieve a balance between anthropogenic emissions by sources and removals by sinks of greenhouse gases within the Union and, as appropriate, achieve negative emissions thereafter;\u2019; (7) Article 17 is amended as follows: (a) in paragraph 2, point (a) is replaced by the following: \u2018(a) information on the progress accomplished towards reaching the objectives, including progress towards the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119, targets and contributions set out in the integrated national energy and climate plan, and towards financing and implementing the policies and measures necessary to meet them, including a review of actual investment against initial investment assumptions;\u2019; (b) in paragraph 4, the first subparagraph is replaced by the following: \u2018The Commission, assisted by the Energy Union Committee referred to in point (b) of Article 44(1), shall adopt implementing acts to set out the structure, format, technical details and process for the information referred to in paragraphs 1 and 2 of this Article, including a methodology for the reporting on the phasing out of energy subsidies, in particular for fossil fuels, pursuant to point (d) of Article 25.\u2019; (8) in Article 29(1), point (b) is replaced by the following: \u2018(b) the progress made by each Member State towards meeting its objectives, including progress towards the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119, targets and contributions and implementing the policies and measures set out in its integrated national energy and climate plan;\u2019; (9) Article 45 is replaced by the following: \u2018Article 45 Review The Commission shall report to the European Parliament and to the Council within six months of each global stocktake agreed under Article 14 of the Paris Agreement on the operation of this Regulation, its contribution to governance of the Energy Union, its contribution to the long-term goals of the Paris Agreement, progress towards the achievement of the 2030 climate and energy targets and the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119, additional Energy Union objectives and the conformity of the planning, reporting and monitoring provisions laid down in this Regulation with other Union law or decisions relating to the UNFCCC and the Paris Agreement. The Commission reports may be accompanied by legislative proposals where appropriate.\u2019; (10) Part 1 of Annex I is amended as follows: (a) in point 3.1.1 of Section A, point (i) is replaced by the following: \u2018i. Policies and measures to achieve the target set under Regulation (EU) 2018/842 as referred to in point 2.1.1 of this Section and policies and measures to comply with Regulation (EU) 2018/841, covering all key emitting sectors and sectors for the enhancement of removals, with an outlook to the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119\u2019; (b) in Section B, the following point is added: \u20185.5. The contribution of planned policies and measures to the achievement of the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119\u2019; (11) in point (c) of Annex VI, point (viii) is replaced by the following: \u2018(viii) an assessment of the contribution of the policy or measure to the achievement of the Union\u2019s climate-neutrality objective set out in Article 2(1) of Regulation (EU) 2021/1119 and to the achievement of the long-term strategy referred to in Article 15 of this Regulation;\u2019. Article 14 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 30 June 2021. For the European Parliament The President D. M. SASSOLI For the Council The President J. P. MATOS FERNANDES (1) OJ C 364, 28.10.2020, p. 143, and OJ C 10, 11.1.2021, p. 69. (2) OJ C 324, 1.10.2020, p. 58. (3) Position of the European Parliament of 24 June 2021 (not yet published in the Official Journal) and decision of the Council of 28 June 2021. (4) OJ L 282, 19.10.2016, p. 4. (5) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a system for greenhouse gas emission allowance trading within the Union and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32). (6) Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26). (7) Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1). (8) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1). (9) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). (10) Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13). (11) Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network (OJ L 126, 21.5.2009, p. 13). (12) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1). (13) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433 I, 22.12.2020, p. 23). (14) Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).", "summary": "European Climate Law European Climate Law SUMMARY OF: Regulation (EU) 2021/1119 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (\u2018European Climate Law\u2019) WHAT IS THE AIM OF THE REGULATION? The regulation: establishes a framework for achieving climate neutrality within the European Union (EU) by 2050 (that is, a balance of EU-wide greenhouse-gas* emissions and their removal regulated in EU law); includes, in addition to the binding objective of climate neutrality in the EU by 2050, the aim of achieving negative emissions in the EU thereafter; provides for a binding EU target of a net domestic reduction in greenhouse-gas emissions by at least 55% (compared to 1990 levels) by 2030, and to set a climate target for 2040 within six months of the first global stocktake under the Paris Agreement; introduces rules to ensure continuous progress towards the global adaptation goal in the Paris Agreement (see summary). KEY POINTS EU institutions and EU Member States must take all necessary measures to meet the regulation\u2019s aims, while taking fairness, solidarity and cost-effectiveness into account. The regulation establishes an independent European Scientific Advisory Board on Climate Change. The Management Board of the European Environment Agency designates the 15 members of the Advisory Board for a term of 4 years following an open selection procedure. They are selected on the basis of their scientific excellence, broad expertise and professional experience in the field of climate and environment science. The 15 senior scientific experts are appointed in a personal capacity. The board\u2019s tasks include: considering the latest scientific findings of the Intergovernmental Panel on Climate Change (IPCC) reports and scientific climate data, in particular with regard to information relevant to the EU; providing scientific advice and issuing reports on existing and proposed EU measures; contributing to the exchange of independent scientific knowledge; identifying action and opportunities to meet the EU\u2019s targets; raising awareness on climate change and its impact. Member States must also: set up a climate advisory body to provide expert scientific advice to the relevant national authorities; establish a multilevel climate and energy dialogue involving local authorities, the civil society, the business community, investors, other relevant stakeholders and the public; submit their 30-year strategy to the European Commission by 1 January 2029, and every 10 years after that, updating this every 5 years if necessary. The regulation defines the following intermediate EU measures, which aim to help the EU meet its 2050 climate-neutrality objective. Reducing net EU greenhouse-gas emissions by at least 55% (compared to 1990 levels) by 2030; in July 2021, the Commission tabled a set of legislative proposals upgrading existing EU legislation and including new initiatives in the implementation of this new target. It will thereafter monitor the progress of the legislative proposals to determine whether the new target will be achieved. Limiting the contribution of net removals to a maximum of 225 million tonnes of CO2 equivalent to ensure sufficient mitigation efforts are made leading up to 2030. With the aim of enhancing the EU\u2019s carbon sink* in line with the 2050 climate-neutrality objective, the regulation also provides for the EU to aim for a higher volume of its net carbon sink in 2030. Allowing for the Commission to propose a climate target for 2040 within 6 months of the first global stocktake under the Paris Agreement. The proposal is to be accompanied by a report containing the projected indicative EU greenhouse-gas budget for 2030-2050. Requiring the Commission to report to the European Parliament and the Council, within 6 months of each global stocktake under the Paris Agreement, on the progress the EU and Member States are making towards meeting the objectives of the regulation. Adaptation to climate change requires: EU institutions and Member States to enhance adaptive capacity, strengthen resilience and reduce vulnerability to climate changeensure adaptation policies are coherent, mutually supportive, provide benefits for sectoral policies, help integrate these measures into all policy areas and focus especially on the most vulnerable people and sectors; the Commission to adopt an EU adaptation strategyguidelines, by 30 July 2022, setting out common principles and practices to identify, classify and manage climate risk when planning, developing, executing and monitoring projects and programmes; Member States to adopt and implement national adaptation strategies and plans, taking into account particularly vulnerable sectors such as agriculture, water and food systems and food security, along with the need to promote nature- and ecosystem-based solutions. Assessment of EU and national progress requires the Commission to: assess by 30 September 2023, and every 5 years thereafter, the progress that the EU and the Member States have made towards the 2050 and adaptation objectives, and whether the EU and national measures towards those objectives are consistent; evaluate whether draft EU measures and legislation, including budgetary proposals, are consistent with the 2030 and 2040 targets and the 2050 climate-neutrality objectives; regularly assess relevant national measures and issue recommendations to a Member State where it finds inconsistencies in ensuring the climate-neutrality objective or inadequate progress made towards enhancing adaptive capacity, strengthening resilience and reducing vulnerability to climate change. The Commission engages with all: parts of society, including the public, social partners and stakeholders, to enable and empower them to contribute towards a just, socially fair, climate-neutral and resilient society; sectors of the economy that prepare indicative voluntary roadmaps towards climate neutrality. The regulation amends: Regulation (EC) No 401/2009 on the European Environment Agency and European Environment Information and Observation Network (see summary) and Regulation (EU) 2018/1999 on the governance of the Energy Union (see summary). FROM WHEN DOES THE REGULATION APPLY? It has applied since 29 July 2021. BACKGROUND In December 2019, the European Council endorsed the objective of a climate-neutral EU by 2050 in line with the objectives of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change. On 4 March 2020, the Commission adopted its proposal for a European Climate Law as an important element of the European Green Deal (see summary). EU action to reduce greenhouse-gas emissions in a cost-effective way is already strongly developed. Between 1990 and 2019, emissions fell by 24%, while the economy grew by 60%. A major cornerstone of the EU\u2019s climate policy is the emissions trading system set up by Directive 2003/87/EC (see summary). For more information, see: European Climate Law (European Commission). KEY TERMS Greenhouse gases: any gas capable of absorbing infrared radiation from the earth\u2019s surface and reradiating it back to earth. Sink: a reservoir that removes carbon dioxide from the atmosphere. MAIN DOCUMENT Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (\u2018European Climate Law\u2019) (OJ L 243, 9.7.2021, pp. 1-17) RELATED DOCUMENTS Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 The European Green Deal (COM(2019) 640 final, 11.12.2019) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, pp. 1-77) Successive amendments to Regulation (EU) 2018/1999 have been incorporated into the original text. This consolidated version is of documentary value only. Communication from the Commission to the European Parliament and the Council \u2014 The Road from Paris: assessing the implications of the Paris Agreement and accompanying the proposal for a Council decision on the signing, on behalf of the European Union, of the Paris agreement adopted under the United Nations Framework Convention on Climate Change (COM(2016) 110 final, 2.3.2016) Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network (Codified version) (OJ L 126, 21.5.2009, pp. 13-22) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, pp. 32-46) See consolidated version. last update 29.07.2021"}
{"article": "26.3.2021 EN Official Journal of the European Union L 107/1 REGULATION (EU) 2021/522 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 March 2021 establishing a Programme for the Union\u2019s action in the field of health (\u2018EU4Health Programme\u2019) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) According to Article 3(1) of the Treaty on European Union (TEU), among the aims of the Union is the promotion of the well-being of its peoples. (2) According to Articles 9 and 168 of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union, a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. (3) Article 168 TFEU provides that the Union is to complement and support national health policies, encourage cooperation between Member States and promote the coordination between their programmes, in full respect of the responsibilities of Member States for the definition of their health policies and for the organisation, management and delivery of health services and medical care. (4) Actions have been taken in particular under the previous programmes of Union action in the field of public health, namely those provided for by Decisions No 1786/2002/EC (4) and No 1350/2007/EC (5) of the European Parliament and of the Council and by Regulation (EU) No 282/2014 of the European Parliament and of the Council (6), to meet the requirements set out in Article 168 TFEU. (5) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, which particularly affect people with chronic conditions. In addition, staff in health care settings, who have been essential during the COVID-19 crisis, have been exposed to great health risks. (6) While Member States are responsible for their health policies, they should protect public health in a spirit of European solidarity, as called for in the communication of the Commission of 13 March 2020 on coordinated economic response to the COVID-19 outbreak. Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for further action at Union level to support cooperation and coordination among the Member States. That cooperation should improve preparedness for, and the prevention and control of, the spread of severe human infections and diseases across borders in order to combat other serious cross-border threats to health and to safeguard and improve the health and well-being of all people in the Union. Preparedness is the key to improving resilience to future threats. In that regard, Member States should be given the possibility of carrying out stress tests on a voluntary basis to improve preparedness and increase resilience. (7) It is therefore appropriate to establish a new and reinforced programme for Union action in the field of health, called the \u2018EU4Health Programme\u2019 (the \u2018Programme\u2019), for the period 2021-2027. In line with the goals of the Union\u2019s action and the Union\u2019s competences in the area of public health, the Programme should emphasise actions in relation to which there are advantages and efficiency gains from collaboration and cooperation at Union level, and actions that have an impact on the internal market. (8) The Programme should be a means of promoting actions in areas where there is a Union added value that can be demonstrated. Such actions should include, inter alia, strengthening the exchange of best practices between Member States, supporting networks for the sharing of knowledge or for mutual learning, addressing cross-border threats to health so as to reduce the risks of such threats and to mitigate their consequences, addressing certain issues relating to the internal market in relation to which the Union can achieve Union-wide high-quality solutions, thereby unlocking the potential of innovation in health, and improving efficiency by avoiding the duplication of activities and optimising the use of financial resources. The Programme should also support capacity-building actions to strengthen strategic planning, access to multisource financing and the capacity to invest in and implement actions of the Programme. In that respect, the Programme should provide country-specific tailor-made assistance to the Member States, or groups of Member States, with the greatest needs. (9) This Regulation lays down a financial envelope for the Programme which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (7), for the European Parliament and the Council during the annual budgetary procedure. This financial envelope comprises an amount of EUR 500 000 000 in 2018 prices in line with the joint declaration by the European Parliament, Council and Commission on the reinforcement of specific programmes and adaptation of basic acts of 22 December 2020 (8). (10) In order for the Programme to be balanced and focused, minimum and maximum shares of the overall budget should be laid down in this Regulation, for certain areas of action, with a view to providing guidance for the allocation of resources in relation to the implementation of the Programme. (11) Due to the serious nature of cross-border threats to health, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthening the capability in the Union to prepare for, respond to and manage any future health crises, the Programme should provide support to actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council (9) and other relevant mechanisms and structures referred to in the communication of the Commission of 11 November 2020 entitled \u2018Building a European Health Union: Reinforcing the EU\u2019s resilience for cross-border health threats\u2019, including actions directed at strengthening preparedness planning and response capacity at national and Union level, at reinforcing the role of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), and at establishing a health emergency preparedness and response authority. Such actions could include building capacity for responding to health crises, preventive measures related to vaccination and immunisation, strengthened surveillance programmes, provision of health information, and platforms to share best practices. In this context, the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness and surveillance, and the management capacity and response capacity of actors at Union and Member State levels, including contingency planning and preparedness exercises, in keeping with the \u2018One Health\u2019 and \u2018Health in All Policies\u2019 approaches. The Programme should facilitate the setting up of an integrated cross-cutting risk communication framework for all phases of a health crisis, namely prevention, preparedness and response. (12) With a view to strengthening capabilities in the Union to prevent, prepare for, respond to and manage health crises, the Programme should provide support to actions taken in the framework of the mechanisms and structures established under relevant Union legislation. That support could include capacity building in health crisis response, including contingency planning and preparedness, preventive measures such as those related to vaccination and immunisation, strengthened surveillance programmes and improved coordination and cooperation. (13) In the context of public health crises, clinical trials and health technology assessment (HTA) can contribute to speeding up the development and identification of effective medical countermeasures. It should therefore be possible for the Programme to provide support to facilitate actions in those fields. (14) With a view to protecting people in vulnerable situations, including those suffering from mental illness and those living with or most affected by communicable or non-communicable diseases and chronic diseases, the Programme should also promote actions which address and prevent the collateral impact of health crises on people belonging to such vulnerable groups and actions which improve mental health. (15) The COVID-19 crisis has highlighted many challenges, including the dependence of the Union on third countries in ensuring the supply of raw materials, active pharmaceutical ingredients, medicinal products, medical devices and personal protective equipment needed in the Union during health crises, in particular pandemics. The Programme should therefore provide support to actions that foster the production, procurement and management of crisis-relevant products within the Union to mitigate the risk of shortages, while ensuring complementarity with other Union instruments. (16) In order to minimise the public health consequences of serious cross-border threats to health, it should be possible for actions supported under the Programme to improve the interoperability of Member States\u2019 health systems through cooperation and the exchange of best practices and also by increasing the number of joint actions. Those actions should ensure that Member States are able to respond to health emergencies, including by undertaking contingency planning, preparedness exercises and the upskilling of the healthcare and public health workforce as well as the establishment, in accordance with national strategies, of mechanisms for the efficient monitoring and needs-driven distribution or allocation of goods and services needed in times of crisis. (17) The provision of information to individuals plays an important role in preventing and responding to diseases. The Programme should therefore support communication activities addressed to the general public or to specific groups of people or professionals, in order to promote disease prevention and healthy lifestyles, to counter misinformation and disinformation as regards the prevention, cause and treatment of diseases, to address vaccine hesitancy and to support efforts to strengthen altruistic behaviour, such as organ and blood donations, in a manner that complements national campaigns on those matters. (18) In synergy with other Union programmes, such as the Digital Europe programme established by a Regulation of the European Parliament and of the Council establishing the Digital Europe programme and repealing Decision (EU) 2015/2240, Horizon Europe - the Framework Programme for Research and Innovation established by a Regulation of the European Parliament and of the Council establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (\u2018Horizon Europe\u2019), the European Regional Development Fund (\u2018ERDF\u2019) established by a Regulation of the European Parliament and of the Council on the European Regional Development Fund and on the Cohesion Fund, the European Social Fund Plus (ESF+) established by a Regulation of the European Parliament and of the Council on the European Social Fund Plus (ESF+), the InvestEU Programme established by Regulation (EU) 2021/523 of the European Parliament and of the Council (10), and the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (11), actions that advance the digital transformation of health services and increase the interoperability of such services, including the development of a European health data space, could be supported under the Programme. (19) Health is an investment, and the Programme should have this concept at its core. Keeping people healthy and active longer and empowering them to take an active role in managing their health by improving their health literacy will have positive effects on health, health inequalities and inequities, access to sexual and reproductive healthcare, quality of life, workers\u2019 health, productivity, competitiveness and inclusiveness, while reducing pressures on national healthcare systems and national budgets. The Programme should also support actions to reduce inequalities in the provision of healthcare, in particular in rural and remote areas, including in the outermost regions, for the purposes of achieving inclusive growth. The Commission has committed to helping Member States to reach the sustainable development targets set in the UN resolution of 25 September 2015 entitled \u2018Transforming our world: the 2030 Agenda for Sustainable Development\u2019(the \u2018UN 2030 Agenda\u2019), in particular Sustainable Development Goal 3 \u2018Ensure healthy lives and promote well-being for all at all ages\u2019. The Programme should therefore contribute to the actions towards reaching those targets. (20) Non-communicable diseases are often the result of a combination of genetic, physiological, environmental and behavioural factors. Non-communicable diseases such as cardiovascular disease, cancer, mental illness, neurological disorders, chronic respiratory disease and diabetes represent major causes of disability, ill-health, health-related retirement, and premature death in the Union, and cause a considerable social and economic impact. To decrease the impact of non-communicable diseases on individuals and society in the Union and to reach Goal 3 of the UN 2030 Agenda Sustainable Development Goals, in particular but not exclusively Target 3.4 of that Goal, namely to reduce premature mortality from non-communicable diseases by one third by 2030, it is essential to provide an integrated response that focuses on health promotion and disease prevention across relevant sectors. (21) The Programme therefore should support health promotion and disease prevention and improve mental health throughout the lifetime of an individual by addressing health risk factors, and health determinants, which would also contribute to the attainment of Goal 3 of the UN 2030 Agenda Sustainable Development Goals. The Programme should also therefore contribute to the objectives set out in the Commission communication of 11 December 2019 entitled \u2018The European Green Deal\u2019 (the \u2018European Green Deal\u2019). (22) The Programme should continue to support actions in the area of reducing and preventing alcohol-related harm, with particular emphasis on protecting the young. (23) The burden of chronic diseases is significant in the Union. It is well acknowledged that prevention and early detection are important in that regard. The Programme should support actions in those areas and should support the development of specific Union preventive and disease management guidelines and therefore aim to reduce the burden of Member States by working together to achieve better and more effective management of chronic diseases. Demographic changes, in particular the ageing of society, challenge the sustainability of health systems. Age-related diseases and disorders, such as dementia, and age-related disabilities, necessitate specific attention. (24) Cancer is the second leading cause of mortality in the Member States after cardiovascular disease. It is also one of the non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. Poor nutrition, physical inactivity, obesity, tobacco use and harmful use of alcohol are risk factors common to other chronic diseases, such as cardiovascular disease, and therefore cancer prevention programmes should be implemented within the context of an integrated approach to preventing chronic diseases. Relevant measures in the \u2018Europe\u2019s Beating Cancer Plan\u2019 set out in the communication of the Commission of 3 February 2021 should benefit from the Programme and from Horizon Europe\u2019s mission on cancer, and should contribute to fostering an integrated approach that covers prevention, screening, early diagnosis, monitoring, treatment and care, as well as improving the quality of life of patients and survivors. (25) It should be possible to support studies on the influence of gender on the characteristics of diseases in order to contribute to improving knowledge and education in that area, thereby improving prevention, diagnosis, monitoring and treatment. (26) The Programme should work in synergy with and in a manner that complements other Union policies, programmes and funds, such as the Digital Europe Programme, Horizon Europe, the rescEU reserve under the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council (12) (the \u2018rescEU reserve\u2019), the Emergency Support Instrument established by Council Regulation (EU) 2016/369 (13), the ESF+, of which the Employment and Social Innovation strand forms part, including as regards synergies in relation to better protecting the health and safety of millions of workers in the Union, the InvestEU Programme, the Single Market Programme established by a Regulation of the European Parliament and of the Council establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014, the ERDF, the Recovery and Resilience Facility, Erasmus+ established by a Regulation of the European Parliament and of the Council establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013, the European Solidarity Corps Programme established by a Regulation of the European Parliament and of the Council establishing the European Solidarity Corps Programme and repealing Regulations (EU) 2018/1475 and (EU) No 375/2014, and external action instruments of the Union, such as the Neighbourhood, Development and International Cooperation Instrument established by a Regulation of the European Parliament and of the Council establishing the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009, and the Instrument for Pre-accession Assistance III established by a Regulation of the European Parliament and of the Council establishing the Instrument for Pre-accession Assistance (IPA III). Where appropriate, common rules should be established with a view to ensuring that there is consistency and complementarity between Union policies, programmes and funds, while ensuring that the specificities of those policies are respected, and with a view to aligning with the strategic requirements of those policies, programmes and funds, such as the enabling conditions under the ERDF and ESF+. The Commission and the Member States should ensure that such synergies and complementarities are duly taken into consideration when drafting the annual work programmes as provided for in this Regulation. (27) The Commission should consult the Member States through a \u2018EU4Health Steering Group\u2019 to be established by this Regulation on the priorities and strategic orientations of the Programme, in order to ensure that there is consistency and complementarity between the Programme and other policies, instruments and actions of the Union, as well as on the implementation of the Programme. (28) The Programme should contribute to the establishment of a reserve of essential crisis-relevant products, in synergy and complementarity with the rescEU reserve, with the emergency support established under Regulation (EU) 2016/369, with the Recovery and Resilience Facility and with other Union policies, programmes and funds, complementing national stockpiles at Union level where needed. (29) Given rising healthcare demand, Member States\u2019 healthcare systems face challenges regarding the availability and affordability of medicinal products. To ensure that there is better public health protection, as well as that patients in the Union are safe and empowered, it is essential that patients and health systems have access to sustainable, efficient, equitable, affordable and high-quality medicinal products, including in the cross-border context, and that they can fully benefit from those medicinal products on the basis of transparent, consistent, and patient-oriented medical information. (30) Given rising healthcare demand, inter alia, the Programme should support the development of a Union system for the monitoring, reporting and notification of shortages of medicinal products and medical devices in order to avoid fragmentation of the internal market and to ensure greater availability and affordability of those medicinal products and medical devices while limiting the extent to which their supply chains depend on third countries. The Programme should therefore encourage the production of medicinal products and medical devices within the Union. In particular, in order to address unmet medical needs, the Programme should provide support to the generation of clinical and real-world evidence to enable the development of, authorisation of, evaluation of and access to effective medicinal products, including generics and biosimilars, to medical devices and to treatment, should promote research and development with respect to new medicinal products, with particular attention to be given to antimicrobials and vaccines to tackle antimicrobial resistance and vaccine-preventable diseases, respectively, should promote incentives to boost the production capacity for antimicrobials, personalised treatment and vaccination, and should foster the digital transformation of healthcare products and platforms for monitoring and collecting information on medicinal products. The Programme should also strengthen decision-making regarding medicinal products by enabling access to and the analysis of real-world healthcare data. The Programme should also help to ensure that the best use is made of research results and facilitate the uptake, scaling-up and deployment of health innovations in healthcare systems and clinical practice. (31) As the optimal delivery and use of medicinal products, and of antimicrobials in particular, yield benefits for individuals and health systems, the Programme should promote their prudent and efficient use in accordance with the One Health approach, with the \u2018European One Health Action Plan against Antimicrobial Resistance (AMR)\u2019 set out in the communication of the Commission of 29 June 2017, and with the \u2018European Union Strategic Approach to Pharmaceuticals in the Environment\u2019 set out in the communication of the Commission of 11 March 2019. The Programme should also foster measures to strengthen the assessment and appropriate management of environmental risks associated with the production, use and disposal of medicinal products. (32) Union health legislation has an immediate impact on public health, on the lives of people, on the efficiency and resilience of health systems and on the proper functioning of the internal market. The regulatory framework for medical products and technologies, including medicinal products, medical devices and substances of human origin, and the regulatory frameworks for tobacco, patients\u2019 rights in cross-border healthcare and serious cross-border threats to health, are essential to the protection of health in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and, in conjunction with relevant bodies such as EMA and ECDC, should provide high-quality, comparable and reliable data, including real-world healthcare data, to support policymaking and monitoring, set targets and develop tools to measure progress. (33) European Reference Networks (ERNs), which were established pursuant to Directive 2011/24/EU of the European Parliament and of the Council (14), are virtual networks of healthcare providers across Europe. They aim to facilitate discussion regarding complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As ERNs can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through ERNs and other transnational networks. (34) ERNs and cross-border cooperation in the provision of healthcare to patients moving between Member States are examples of areas where integrated work between Member States has been shown to have strong added value and great potential to increase the efficiency of health systems and thus to improve public health in general. Collaboration as regards HTA is another area that is bringing added value to Member States. The Programme should therefore support activities that enable integrated and sustained coordinated work, thereby also serving to foster the implementation of best practices that are aimed at distributing the available resources to the population and areas concerned in the most effective way so as to maximise their impact. (35) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (15) (the \u2018Financial Regulation\u2019) applies to this Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (36) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions concerned and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. That choice should include consideration of the use of lump sums, flat-rate financing and unit costs, as well as the use of financing that is not linked to costs as envisaged in Article 125(1) of the Financial Regulation. Technical and financial reporting requirements for the beneficiaries should be such as to ensure that there is compliance with applicable financial provisions while minimising the administrative burden. (37) In order to optimise the added value and impact from investments funded wholly or in part through the budget of the Union, synergies should be sought in particular between the Programme and other Union programmes, including those under shared-management. To maximise those synergies, and avoid duplications, appropriate mechanisms should be provided for, including cumulative funding in an action from the Programme and another Union programme, as long as such cumulative funding does not exceed the total eligible costs of the action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility of declaring the same cost or expenditure on a pro-rata basis under the Programme and another Union programme, in order to ensure that there is detailed and transparent reporting. (38) Given the specific nature of the objectives and actions covered by the Programme, the respective competent authorities of the Member States will be best placed, in some cases, to implement actions related to the Programme. Those authorities, designated by the Member States, should therefore be considered to be identified beneficiaries for the purpose of Article 195 of the Financial Regulation and grants should therefore be awarded to those authorities without the prior publication of calls for proposals. Investments under the Programme should be implemented in close cooperation with Member States. (39) Under Article 193(2) of the Financial Regulation, a grant may be awarded for an action, which has already begun, provided that the applicant can demonstrate the need to start the action prior to the signature of the grant agreement. However, costs incurred prior to the date of submission of the grant application are not eligible costs, except in duly justified exceptional cases. In order to avoid any disruption to Union support which could be prejudicial to the Union\u2019s interests, it should be possible to provide for the eligibility of activities and costs from the beginning of the 2021 financial year in the financing decision, for a limited period at the beginning of the multiannual financial framework 2021-2027, and only in duly justified cases, even if those activities were implemented and those costs were incurred before the grant application was submitted. (40) ERNs are approved by the Board of Member States of the ERNs, following the approval procedure set out in Commission Implementing Decision 2014/287/EU (16). ERNs should therefore be considered to be identified beneficiaries for the purpose of Article 195 of the Financial Regulation, and the grants to ERNs should therefore be awarded without prior publication of calls for proposals. Direct grants should also be awarded to other entities that have been designated in accordance with Union rules, for example reference laboratories and centres, centres of excellence and transnational networks. (41) Given the commonly agreed values of solidarity in relation to equitable and universal coverage of quality health services as a basis for the Union\u2019s policies in this area and the fact that the Union has a central role to play in accelerating progress, coordination and cooperation in tackling global health challenges as set out in the Council conclusions of 10 May 2010 on the EU role in Global Health, and as expressed in the UN 2030 Agenda Sustainable Development Goals, the Programme should reinforce the Union\u2019s support for international and global health initiatives, in particular for initiatives by the WHO, with a view to improving health, addressing health inequalities and strengthening protection against global health threats. (42) In order to maximise the effectiveness and efficiency of actions at Union and international level, cooperation should be developed with relevant international organisations such as the United Nations and the World Bank, as well as with the Council of Europe and the Organisation for Economic Co-operation and Development (OECD), when implementing the Programme. In order to increase impact, synergies should also be sought with the national organisations of Member States that are active in global health. In accordance with Council Decision 2013/755/EU (17), persons and entities established in Overseas Countries and Territories (OCTs) should be eligible for funding under the Programme, subject to the rules and objectives of the Programme and to possible arrangements applicable to the Member State to which the relevant OCTs are linked. (43) The implementation of the Programme should be supported by extensive outreach activities to ensure that the views and needs of civil society are duly represented and taken into account. To this end, the Commission should seek feedback on the Programme\u2019s priorities and strategic orientations and on the needs to be addressed through its actions from relevant stakeholders once a year, including from representatives of civil society and patients\u2019 associations, academics and organisations of healthcare professionals. Each year, before the end of the preparatory work for the work programmes, the Commission should also inform the European Parliament about the progress regarding such preparatory work and on the outcome of its outreach activities towards stakeholders. (44) Third countries which are members of the European Economic Area (EEA) are able to participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (18), which provides for the implementation of such programmes on the basis of a decision adopted under that agreement. A specific provision should be introduced in this Regulation requiring third countries that participate in the Programme to grant the necessary rights and access required for the authorising officer responsible, the European Anti-Fraud Office (OLAF) and the Court of Auditors to comprehensively exercise their respective competences. (45) Cooperation with third countries should be strengthened as regards the exchange of knowledge and best practices in order to improve health systems\u2019 preparedness and response capacity. (46) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (19) and Council Regulations (EC, Euratom) No 2988/95 (20), (Euratom, EC) No 2185/96 (21) and (EU) 2017/1939 (22), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, OLAF has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union, as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (23). (47) In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (48) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (49) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement adopted under the United Nations Framework Convention on Climate Change and the UN Agenda 2030 Sustainable Development Goals, the Programme should contribute to mainstreaming climate action in the Union\u2019s policies and to the achievement of an overall target of at least 30 % of the total amount of the Union budget and the European Union Recovery Instrument, established by Council Regulation (EU) 2020/2094 (24), expenditures, supporting climate objectives. The Programme should support activities that would respect the climate and environmental standards and priorities of the Union and the \u2018do no harm\u2019 principle of the European Green Deal. Relevant actions should be identified during the Programme\u2019s preparation and implementation, and reassessed in the context of its interim evaluation. (50) According to Article 8 TFEU, in all its activities, the Union shall aim to eliminate inequalities and to promote equality between men and women. Gender equality, as well as rights and equal opportunities for all, and the mainstreaming of those objectives should be taken into account and promoted throughout the assessment, preparation, implementation and monitoring of the Programme. (51) It should be possible for the policy objectives of the Programme to also be addressed through financial instruments and budgetary guarantees under the InvestEU Fund provided for by the InvestEU Programme. Financial support should be used to address market failures and sub-optimal investment situations, in a proportionate manner. Actions funded by the Programme should not duplicate or crowd out private financing or distort competition in the internal market. In general, actions should have Union added value. (52) The implementation of the Programme should be such that the responsibilities of the Member States for the definition of their health policies and for the organisation and delivery of health services and medical care are respected. Strong involvement of Member States in the governance and implementation of the Programme should be ensured. (53) Given the nature and potential scale of cross-border threats to health, the objectives of protecting people in the Union from such threats and increasing health crisis prevention and preparedness cannot be sufficiently achieved by the Member States acting alone. In accordance with the principle of subsidiarity as set out in Article 5 TEU, action at Union level can also be taken to support Member States\u2019 efforts in the pursuit of a high level of protection of public health, to improve the availability, sustainability, acceptability, accessibility, safety and affordability in the Union of medicinal products, medical devices and crisis-relevant products and services, to support innovation, to support integrated and coordinated work and the implementation of best practices among Member States, and to address inequalities and inequities in access to healthcare throughout the Union in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level, while respecting the Member States\u2019 competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (54) In order to allow possible adjustments necessary to achieve the Programme\u2019s objectives to be made, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the review, amendment and addition of the indicators set out in Annex II to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (25). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (55) Member States and participating countries have designated National Focal Points to assist the Commission in the promotion of the third Programme for the Union\u2019s action in the field of health (2014-2020) established by Regulation (EU) No 282/2014, and, where relevant, in the dissemination of its results and the information available on its impact in the Member States and participating countries. Given the importance of such activities, it is appropriate to support such activities under the Programme in order to continue them. (56) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt implementing acts establishing annual work programmes in accordance with the criteria set out in this Regulation, approving certain eligible actions and establishing rules on technical and administrative arrangements necessary for the implementation of the actions of the Programme and on uniform templates for the collection of data necessary to monitor the implementation of the Programme. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of European Parliament and of the Council (26). The examination procedure should be used for the adoption of those implementing acts given that they relate to a programme with substantial implications. (57) The value and impact of the Programme should be regularly and closely monitored and evaluated. The evaluation should focus on the goals of the Programme and take into account the fact that the achievement of the Programme\u2019s objectives could require a period that is longer than the length of the Programme. To that end, an interim evaluation report should be drawn up, as well as an evaluation report at the end of the Programme, in order to assess the implementation of the priorities of the Programme. (58) As the third Programme for the Union\u2019s action in the field of health (2014-2020) has come to an end, Regulation (EU) No 282/2014 has become obsolete and should be repealed. (59) In order to ensure continuity in providing support in the field of health and to allow implementation to start from the beginning of the multiannual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the EU4Health Programme (the \u2018Programme\u2019) for the period of the multiannual financial framework 2021 to 2027. The duration of the Programme is aligned with the duration of the multiannual financial framework. This Regulation also lays down the objectives of the Programme, the budget for the period from 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018associated country\u2019 means a third country which is party to an agreement with the Union that allows for its participation in the Programme, in accordance with Article 6; (2) \u2018blending operations\u2019 means actions supported by the Union budget, including within blending facilities pursuant to point (6) of Article 2 of the Financial Regulation, combining non-repayable forms of support, and/or financial instruments from the Union budget with repayable forms of support from development institutions or other public finance institutions, as well as from commercial finance institutions and commercial investors; (3) \u2018health crisis\u2019 means a crisis or serious incident arising from a threat of human, animal, plant, food, biological, chemical, environmental or unknown origin, which has a public health dimension and which requires urgent action by authorities; (4) \u2018crisis-relevant products\u2019 means products, tools and substances that are necessary, in the context of a health crisis, for the prevention, diagnosis or treatment of a disease and its consequences, or for the monitoring and the epidemiological surveillance of diseases and infections, including, but not limited to, medicinal products, such as vaccines and their intermediates, active pharmaceutical ingredients and raw materials, as well as medical devices and hospital and medical equipment, such as ventilators, protective clothing and equipment, diagnostic materials and tools, personal protective equipment, disinfectants and their intermediary products, and the raw materials necessary for their production; (5) \u2018One Health approach\u2019 means a multisectoral approach which recognises that human health is connected to animal health and to the environment, and that actions to tackle threats to health must take into account those three dimensions; (6) \u2018European Reference Networks (ERNs)\u2019 means the networks referred to in Article 12 of Directive 2011/24/EU; (7) \u2018legal entity\u2019 means a natural person, or a legal person created and recognised as such under national, Union or international law which has legal personality and which can, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (8) \u2018third country\u2019 means a country that is not a Member State of the European Union; (9) \u2018serious cross-border threat to health\u2019 means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection; (10) \u2018Health in All Policies\u2019 means an approach to the development, implementation and review of public policies, regardless of the sector, whereby the health implications of decisions are taken into account, and which seeks to achieve synergies and to avoid harmful health impacts being caused by such policies, in order to improve the health of the population and health equity; (11) \u2018health determinants\u2019 means a range of factors that influence the health status of a person, such as behaviour-related, biological, socio-economic and environmental factors; (12) \u2018emergency support\u2019 means a needs-based emergency response that complements the response of the affected Member States and is aimed at preserving life, preventing and alleviating human suffering, and maintaining human dignity, wherever the need arises as a result of serious cross-border threats to health. Article 3 General objectives The Programme shall have a Union added value and complement the policies of the Member States, in order to improve human health throughout the Union and to ensure a high level of protection of human health in all Union policies and activities. It shall pursue the following general objectives in keeping with the One Health approach, where applicable: (a) improving and fostering health in the Union to reduce the burden of communicable and non-communicable diseases, by supporting health promotion and disease prevention, by reducing health inequalities, by fostering healthy lifestyles and by promoting access to healthcare; (b) protecting people in the Union from serious cross-border threats to health and strengthening the responsiveness of health systems and coordination among the Member States in order to cope with serious cross-border threats to health; (c) improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and supporting innovation regarding such products; (d) strengthening health systems by improving their resilience and resource efficiency, in particular through: (i) supporting integrated and coordinated work between Member States; (ii) promoting the implementation of best practices and promoting data sharing; (iii) reinforcing the healthcare workforce; (iv) tackling the implications of demographic challenges; and (v) advancing digital transformation. Article 4 Specific objectives The general objectives referred to in Article 3 shall be pursued through the following specific objectives, ensuring a high level of human health protection in all Union policies and activities in keeping with the One Health approach, where applicable: (a) in synergy with other relevant Union actions, supporting actions for disease prevention, for health promotion and for addressing health determinants, including through the reduction of damage to health resulting from illicit drug use and addiction, supporting actions to address inequalities in health, to improve health literacy, to improve patient rights, patient safety, quality of care and cross-border healthcare, and supporting actions for the improvement of the surveillance, diagnosis and treatment of communicable and non-communicable diseases, in particular cancer and paediatric cancer, as well as supporting actions to improve mental health, with special attention given to new care models and the challenges of long term care, in order to strengthen the resilience of the health systems in the Union; (b) strengthening the capability of the Union for prevention of, preparedness for, and rapid response to, serious cross-border threats to health in accordance with relevant Union legislation, and improving the management of health crises, particularly through the coordination, provision and deployment of emergency healthcare capacity, supporting data gathering, information exchange, surveillance, the coordination of voluntary stress testing of national healthcare systems, and the development of quality healthcare standards at national level; (c) supporting actions to enhance the availability, accessibility and affordability of medicinal products, medical devices and crisis-relevant products by encouraging sustainable production and supply chains and innovation in the Union, while supporting the prudent and efficient use of medicinal products, in particular antimicrobials, and actions to support the development of medicinal products that are less harmful for the environment, as well as the environmentally friendly production and disposal of medicinal products and medical devices; (d) in synergy with other Union instruments, programmes and funds, without prejudice to Member State competences, and in close cooperation with relevant Union bodies, supporting actions complementing national stockpiling of essential crisis-relevant products, at Union level, where needed; (e) in synergy with other Union instruments, programmes and funds, without prejudice to Member State competences and in close cooperation with the ECDC, establishing a structure and training resources for a reserve of medical, healthcare and support staff allocated voluntarily by Member States for its mobilisation in the event of a health crisis; (f) strengthening the use and re-use of health data for the provision of healthcare and for research and innovation, promoting the uptake of digital tools and services, as well as the digital transformation of healthcare systems, including by supporting the creation of a European health data space; (g) enhancing access to quality, patient-centred, outcome-based healthcare and related care services, with the aim of achieving universal health coverage; (h) supporting the development, implementation and enforcement and, where necessary, the revision of Union health legislation and supporting the provision of valid, reliable and comparable high-quality data for evidence-based decision-making and monitoring, and promoting the use of health impact assessments of other relevant Union policies; (i) supporting integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, supporting work on HTA, and strengthening and scaling up networking through ERNs and other transnational networks, including in relation to diseases other than rare diseases, to increase the coverage of patients and improve the response to low prevalence and complex communicable and non-communicable diseases; (j) supporting global commitments and health initiatives by reinforcing the Union\u2019s support for actions by international organisations, in particular actions by the WHO, and fostering cooperation with third countries. Article 5 Budget 1. The financial envelope for the implementation of the Programme for the period 2021 - 2027 shall be EUR 2 446 000 000 in current prices. 2. As a result of the Programme-specific adjustment provided for in Article 5 of Council Regulation (EU, Euratom) 2020/2093 (27), the amount referred to in paragraph 1 of this Article shall be increased by an additional allocation of EUR 2 900 000 000 in 2018 prices as specified in Annex II to that Regulation. 3. The amounts referred to in paragraphs 1 and 2 may also be used for technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems. 4. The distribution of the amounts referred to in paragraphs 1 and 2 shall comply with the following: (a) a minimum of 20 % of the amounts shall be reserved for health promotion and disease prevention actions as referred to in point (a) of Article 4; (b) a maximum of 12,5 % of the amounts shall be reserved for procurement complementing national stockpiling of essential crisis-relevant products at Union level as referred to in point (d) of Article 4; (c) a maximum of 12,5 % of the amounts shall be reserved for supporting global commitments and health initiatives as referred to in point (j) of Article 4; (d) a maximum of 8 % of the amounts shall be reserved for covering administrative expenses as referred to in paragraph 3. 5. Appropriations related to activities under point (c) of Article 9(1) of this Regulation, shall constitute assigned revenue within the meaning of point (a) of paragraph 3, and paragraph 5, of Article 21 of the Financial Regulation. 6. Budgetary commitments extending over more than one financial year may be broken down over several years into annual instalments. 7. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, for a limited period in duly justified cases specified in the financing decision, activities supported under this Regulation and their underlying costs may be considered eligible as of 1 January 2021, even if those activities were implemented and those costs were incurred before the grant application was submitted. 8. If necessary, appropriations may be entered in the budget beyond 31 December 2027 to cover the expenses referred to in paragraph 3 to enable the management of actions not completed by 31 December 2027. Article 6 Third countries associated to the Programme 1. The Programme shall be open to the participation of the following third countries: (a) members of the European Free Trade Association which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country in any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programme; (ii) lays down the conditions of participation in the Union programme, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country a decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. 2. The contributions referred to in point (d)(ii) of paragraph 1 shall constitute assigned revenue in accordance with Article 21(5) of the Financial Regulation. CHAPTER II FUNDING Article 7 Implementation and forms of Union funding 1. The Programme shall be implemented in direct management in accordance with the Financial Regulation or in indirect management with the bodies referred to in point (c) of Article 62(1) of that Regulation. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular in the form of grants, prizes and procurement. 3. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and may be considered as a sufficient guarantee under the Financial Regulation. The Commission shall lay down specific rules for the operation of the mechanism. 4. Where the Commission implements emergency support operations through a non-governmental organisation, the criteria concerning financial and operational capacity shall be deemed to be satisfied if there is a framework partnership agreement in force between that organisation and the Commission pursuant to Council Regulation (EC) No 1257/96 (28). Article 8 Grants 1. Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation. 2. Grants may be used in combination with financing from the European Investment Bank, from national promotional banks or from other development or public financial institutions, as well as in combination with financing from private-sector finance institutions and from public-sector or private-sector investors, including through public-public or public-private partnerships. 3. Grants paid by the Union shall not exceed 60 % of eligible costs for an action relating to an objective of the Programme or for the functioning of a non-governmental body. In cases of exceptional utility, the contribution by the Union may be up to 80 % of eligible costs. Actions with a clear Union added value shall be considered to have exceptional utility, inter alia, where: (a) at least 30 % of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90 % of the Union average; or (b) bodies from at least 14 participating Member States participate in the action, of which at least four are Member States whose GNI per inhabitant is less than 90 % of the Union average. 4. In the case of the direct grants referred to in Article 13(6) and (7), such grants may be up to 100 % of eligible costs. Article 9 Procurement in health emergency situations 1. In cases where the emergence or development of a serious cross-border threat to health has been notified under Article 9 of Decision No 1082/2013/EU, or where a situation of public health emergency has been recognised under Article 12 of that Decision, procurement under this Regulation may take any of the following forms: (a) joint procurement with the Member States as referred to in Article 165(2) of the Financial Regulation whereby Member States may acquire, rent or lease fully the jointly procured capacities; (b) procurement by the Commission on behalf of the Member States on the basis of an agreement between the Commission and the Member States; (c) procurement by the Commission acting as wholesaler by buying, stocking and reselling or donating supplies and services, including rentals, for the benefit of Member States or partner organisations selected by the Commission. 2. In the event of the procurement procedure referred to in point (b) of paragraph 1 being used, the ensuing contracts shall be concluded by either of the following: (a) by the Commission, where the services or goods are to be provided or delivered to Member States or to partner organisations selected by the Commission; (b) by the participant Member States, where they are to directly acquire, rent or lease the capacities procured for them by the Commission. 3. In the event of the procurement procedures referred to in points (b) and (c) of paragraph 1 being used, the Commission shall comply with the Financial Regulation for its own procurement. Article 10 Blending operations Blending operations under the Programme shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. Article 11 Cumulative funding 1. An action that has received a contribution under the Programme may also receive a contribution from any other Union programme, including Funds under shared management, provided that the contributions do not cover the same costs. 2. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. 3. The cumulative funding shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. CHAPTER III ACTIONS Article 12 Eligible actions Only actions that implement the objectives listed in Articles 3 and 4, in particular the actions set out in Annex I, shall be eligible for funding. Article 13 Eligible legal entities 1. In order to be eligible for funding, legal entities shall, in addition to the criteria set out in Article 197 of the Financial Regulation: (a) be established in any of the following: (i) a Member State or an overseas country or territory linked to it; (ii) a third country associated to the Programme; or (iii) a third country listed in the annual work programme established in accordance with Article 17 (\u2018annual work programme\u2019) under the conditions specified in paragraphs 2 and 3; or (b) be a legal entity created under Union law or an international organisation. 2. Legal entities that are established in a third country which is not associated to the Programme may in exceptional cases be eligible to participate in the Programme where such participation is necessary for the achievement of the objectives of a given action. The assessment of that necessity shall be duly reflected in the funding decision. 3. Legal entities that are established in a third country which is not associated to the Programme shall bear the cost of their participation. 4. Natural persons shall not be eligible for grants under the Programme. 5. Under the Programme, direct grants may be awarded without a call for proposals to fund actions, if such grants are duly justified, and if those actions have a Union added value that is explicitly provided for in the annual work programmes and are co-financed by the competent authorities that are responsible for health in the Member States or in third countries associated to the Programme, by relevant international health organisations, or by public sector bodies or non-governmental bodies that are mandated by those competent authorities, regardless of whether those bodies act individually or as a network. 6. Under the Programme, direct grants shall be awarded without a call for proposals to ERNs. Direct grants may also be awarded to other transnational networks set out in accordance with Union law. 7. Under the Programme, direct grants may be awarded without a call for proposals to fund actions of the WHO where financial support is necessary for the implementation of one or more of the specific objectives of the Programme that have a Union added value that is explicitly provided for in the annual work programmes. 8. Under the Programme, grants may be awarded without a call for proposals to fund the functioning of non-governmental bodies where financial support is necessary for the implementation of one or more of the specific objectives of the Programme that have a Union added value that is explicitly provided for in the annual work programmes, as long as those bodies fulfil all of the following criteria: (a) they are non-profit-making and independent of industry, commercial and business or other conflicting interests; (b) they work in the public health area, pursue at least one of the specific objectives of the Programme and play an effective role at Union level; (c) they are active at Union level and in at least half of the Member States, with a balanced geographical coverage of the Union. The Commission shall duly reflect the analysis of the fulfilment of those criteria in the funding decision. Article 14 Eligible costs 1. Subject to Article 186 of the Financial Regulation, and point (a) of the second subparagraph of Article 193(2) of that Regulation, costs incurred prior to the date of submission of the grant application shall be eligible for funding with respect to actions: (a) implementing the objective referred to in point (b) of Article 3 of this Regulation; or (b) implementing objectives other than those referred to in point (a) of this paragraph, in duly justified exceptional cases, provided that those costs are directly linked to the implementation of the supported actions and activities. 2. Costs eligible under point (a) of paragraph 1 that relate to measures aiming to address suspected occurrences of a disease that could trigger a cross-border threat to health shall be eligible from the date of notification of the suspected occurrence of that disease to the Commission, provided that the occurrence or presence of that disease is subsequently confirmed. 3. In exceptional cases, during a health crisis caused by a serious cross-border threat to health as defined in point (g) of Article 3 of Decision No 1082/2013/EU, costs incurred by entities established in non-associated countries may be considered eligible if those costs are duly justified for reasons concerning countering the spread of the risk for the protection of the health of people in the Union. CHAPTER IV GOVERNANCE Article 15 Joint policy implementation 1. A EU4Health Steering Group shall be established. 2. The Members of the EU4Health Steering Group shall be the Commission and the Member States. Each Member State shall appoint one member and one alternate member to the EU4Health Steering Group. The Commission shall provide the secretariat of the EU4Health Steering Group. 3. The Commission shall consult the EU4Health Steering Group: (a) on the Commission\u2019s preparatory work for the annual work programmes; (b) each year, at least 6 months in advance of the presentation of the draft of the annual work programme to the committee referred to in Article 23(1), on the priorities and strategic orientations of the annual work programme. 4. The EU4Health Steering Group shall: (a) work towards ensuring that there is consistency and complementarity between the Member States\u2019 health policies as well as between the Programme and other policies, instruments and actions of the Union, including those relevant to the Union agencies; (b) follow up the implementation of the Programme and propose any necessary adjustments based on evaluations; (c) adopt its rules of procedure, which shall contain provisions to ensure that the group will meet at least three times a year, in person where appropriate, thus allowing for a regular and transparent exchange of views among Member States. Article 16 Stakeholder consultation and information of the European Parliament 1. The Commission shall consult with relevant stakeholders, including representatives of civil society and patient organisations, to seek their views on: (a) the priorities and strategic orientation of the annual work programme; (b) the needs to be addressed through the annual work programme and the results achieved through it. 2. For the purposes of paragraph 1, the Commission shall organise the consultation and information of stakeholders at least once a year, in the six months preceding the presentation of the draft work programme to the committee referred to in Article 23(1). 3. The Commission may at any time seek the views of relevant decentralised agencies and of independent experts in the field of health on technical or scientific matters of relevance for the implementation of the Programme. 4. Each year, prior to the last meeting of the EU4Health Steering Group, the Commission shall present to the European Parliament the outcomes of the proceedings of the EU4Health Steering Group and the consultation of stakeholders referred to in paragraphs 1 and 2. Article 17 Implementation of the Programme 1. The Commission shall implement the Programme by establishing annual work programmes in accordance with the Financial Regulation. 2. The Commission shall adopt, by means of implementing acts: (a) the annual work programmes, which shall set out, in particular: (i) the actions to be undertaken, including the indicative allocation of financial resources; (ii) the overall amount reserved for blending operations; (iii) eligible actions falling under Article 7(3) and (4); (iv) eligible actions by legal entities referred to in point (b) of Article 13(1); (v) eligible actions by legal entities from a third country not associated to the Programme but listed in the annual work programme under the conditions laid down in Article 13(2) and (3); (b) decisions approving actions with a cost of EUR 20 000 000 or more; (c) rules establishing: (i) the technical and administrative arrangements necessary for the implementation of the actions of the Programme; (ii) uniform templates for the collection of data necessary to monitor the implementation of the Programme. 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2). Article 18 Data protection In managing and implementing the Programme, the Commission and the Member States shall ensure that there is compliance with all relevant legal provisions regarding personal data protection and, where appropriate, that mechanisms are introduced to ensure that such data remain confidential and safe. CHAPTER V MONITORING, EVALUATION AND CONTROL Article 19 Monitoring and reporting 1. Indicators to report on progress of the Programme towards the achievement of the general and specific objectives listed in Articles 3 and 4 are set out in Annex II. 2. The Commission is empowered to adopt delegated acts in accordance with Article 25 to amend Annex II with regard to the indicators where considered necessary. 3. The performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently, effectively, and in a timely manner. To that end, the Commission shall adopt implementing acts establishing proportionate reporting requirements for recipients of Union funds and, where appropriate, for Member States. Article 20 Evaluation 1. Evaluations provided for in Article 34(3) of the Financial Regulation shall be carried out by the Commission in a sufficiently timely manner to feed into the decision-making process. 2. The Commission shall present an interim evaluation of the Programme no later than 31 December 2024. The interim evaluation shall be the basis for adjusting the implementation of the Programme as appropriate. 3. The Commission shall present a final evaluation at the end of the Programme and no later than four years after the end of the period referred to in Article 1. 4. The Commission shall publish and communicate the conclusions of both the interim and final evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 21 Audits Audits of the use of Union contributions, including audits carried out by persons or entities other than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance referred to in Article 127 of the Financial Regulation. Article 22 Protection of the financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF, and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 23 Committee procedure 1. The Commission shall be assisted by a EU4Health Programme Committee. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 24 Consistency and complementarity with other Union policies, instruments and actions The Commission and the Member States shall ensure that there is overall consistency, synergy and complementarity between the Programme and other Union policies, instruments and actions, including those relevant to the Union agencies, including through their common work in the EU4Health Steering Group. Article 25 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 19(2) shall be conferred on the Commission for a period of seven years from 26 March 2021. 3. The delegation of power referred to in Article 19(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 19(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. CHAPTER VI TRANSITIONAL AND FINAL PROVISIONS Article 26 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions related to the Programme, to actions taken pursuant to the Programme and to the results obtained. 3. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Articles 3 and 4. Article 27 Repeal Regulation (EU) No 282/2014 is repealed with effect from 1 January 2021, without prejudice to Article 28 of this Regulation. Article 28 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulation (EU) No 282/2014 which shall continue to apply to those actions until their closure. 2. The financial envelope for the Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the measures adopted under Regulation (EU) No 282/2014 and the Programme. Article 29 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 March 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A.P. ZACARIAS (1) OJ C 429, 11.12.2020, p. 251. (2) OJ C 440, 18.12.2020, p. 131. (3) Position of the European Parliament of 9 March 2021 (not yet published in the Official Journal) and decision of the Council of 17 March 2021. (4) Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) (OJ L 271, 9.10.2002, p. 1). (5) Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the field of health (2008-13) (OJ L 301, 20.11.2007, p. 3). (6) Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme for the Union\u2019s action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC (OJ L 86, 21.3.2014, p. 1). (7) OJ L 433I, 22.12.2020, p. 28. (8) OJ C 444I, 22.12.2020, p. 1. (9) Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). (10) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (see page 30 of this Official Journal). (11) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17). (12) Decision (EU) 2019/420 of the European Parliament and of the Council of 13 March 2019 amending Decision No 1313/2013/EU on a Union Civil Protection Mechanism (OJ L 77I , 20.3.2019, p. 1). (13) Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union (OJ L 70, 16.3.2016, p. 1). (14) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients\u2019 rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). (15) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (16) Commission Implementing Decision 2014/287/EU of 10 March 2014 setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks (OJ L 147, 17.5.2014, p. 79). (17) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (\u2018Overseas Association Decision\u2019) (OJ L 344, 19.12.2013, p. 1). (18) OJ L 1, 3.1.1994, p. 3. (19) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (20) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (21) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (22) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (23) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (24) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I , 22.12.2020, p. 23). (25) OJ L 123, 12.5.2016, p. 1. (26) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (27) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, p. 11). (28) Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid (OJ L 163, 2.7.1996, p. 1). ANNEX I LIST OF POSSIBLE ELIGIBLE ACTIONS PROVIDED FOR IN ARTICLE 12 1. Actions meeting the objective laid down in point (a) of Article 4 (a) Supporting the establishment and implementation of programmes assisting Member States and supporting the actions of Member States to improve health promotion and disease prevention; (b) Supporting the implementation and further development of surveys, studies, collection of comparable data and statistics, where relevant including disaggregated data by gender and age, methodologies, classifications, microsimulations, pilot studies, indicators, knowledge brokering and benchmark exercises; (c) Supporting Member States\u2019 actions to put in place healthy and safe urban, work and school environments, to enable healthy life choices, to promote healthy diets and regular physical activity, taking into account the needs of vulnerable groups at every stage of their life, with the aim of promoting life-long health; (d) Supporting Member States in delivering effective responses to communicable diseases, and in the prevention, surveillance, diagnosis and treatment of such diseases; (e) Supporting Member States\u2019 actions in health promotion and disease prevention throughout the lifetime of an individual and by addressing health risk factors, such as obesity, unhealthy diets and physical inactivity; (f) Supporting actions to improve mental health; (g) Supporting actions to complement measures of Member States in reducing damage to health due to illicit drug use and addiction, including information and prevention; (h) Supporting implementing policies and actions to reduce health inequalities and inequities in relation to healthcare; (i) Supporting actions to enhance health literacy; (j) Supporting the promotion and implementation of the recommendations of the European Code against Cancer and supporting the revision of the current edition of that Code; (k) Actions to support the implementation of cancer registries in all Member States; (l) Furthering the cooperation among relevant national bodies of participating Member States with a view to supporting the creation of a virtual European network of excellence in order to strengthen research on all types of cancer, including paediatric cancer, and further the collection and exchange of clinical data and the translation of research findings into everyday care and treatment of cancer patients; (m) Supporting actions to improve the quality of cancer care, including as regards prevention, screening, early diagnosis, monitoring and treatment, supportive and palliative care, in an integrative and patient-centred approach and supporting the establishment of quality assurance schemes for cancer centres or other centres treating cancer patients, including those treating paediatric cancer; (n) Supporting the establishment of quality assurance schemes for cancer centres and centres treating cancer patients; (o) Supporting mechanisms for cross-specialty capacity building and continuous education, in particular in the area of cancer care; (p) Actions supporting the quality of life of cancer survivors and caregivers, including provision of psychological support, pain management and health-related aspects of professional reintegration; (q) Strengthening collaboration on patient rights, patient safety and quality of care; (r) Supporting actions regarding epidemiological surveillance, thus contributing to assessment of factors that affect or determine the health of people; (s) Supporting, in synergy with other programmes, actions to improve the geographical distribution of the healthcare workforce and actions for the avoidance of \u2018medical deserts\u2019, without prejudice to Member State competences; (t) Supporting the development of guidelines for preventing and managing communicable and non-communicable diseases, and of tools and networks for the exchange of best practices in that area; (u) Supporting Member States\u2019 actions to address health determinants, including reducing alcohol-related harm and tobacco use; (v) Supporting tools and platforms to collect real-world evidence on the safety, effectiveness and impact of vaccines after use; (w) Supporting initiatives to improve vaccination coverage rates in the Member States; (x) Communication activities addressed to the public and stakeholders to promote Union action in the areas mentioned in this Annex; (y) Awareness-raising campaigns and communications activities for the general public as well as for targeted groups, aimed at preventing and addressing vaccine hesitancy, misinformation and disinformation as regards prevention, causes and treatment of diseases, in a manner that complements national campaigns and communications activities on those matters; (z) Communication activities addressed to the public on health risks and health determinants; (za) Supporting actions to reduce the risk of healthcare-acquired infections. 2. Actions meeting the objective laid down in point (b) of Article 4 (a) Strengthening the critical health infrastructure to cope with health crises, by supporting the setup of tools for surveillance, forecast, prevention and management of outbreaks; (b) Supporting actions to foster Union-wide health crisis prevention and preparedness, and the management capacity and response capacity of actors at Union and national level, including voluntary stress tests, contingency planning and preparedness exercises; supporting the development of quality health standards at national level, mechanisms for the efficient coordination of preparedness and response, and the coordination of those actions at Union level; (c) Supporting actions for setting up an integrated cross-cutting risk communication framework covering all phases of a health crisis, namely prevention, preparedness, response and recovery; (d) Supporting preventive actions to protect vulnerable groups from health threats and actions to adapt the response to and the management of health crises to the needs of those vulnerable groups such as actions to secure basic care for patients with chronic or rare diseases; (e) Supporting actions to address the collateral health consequences of a health crisis, in particular the consequences for mental health, on patients suffering from cancer, from chronic diseases and other vulnerable situations, including people living with addiction, with HIV/AIDS, or suffering from hepatitis and tuberculosis; (f) Supporting, in synergy with other programmes, training and educational programmes for the upskilling of healthcare and public health workforces, and programmes for temporary exchanges of staff, in particular with the aim of improving their digital skills; (g) Supporting the establishment and coordination of Union Reference Laboratories, Union Reference Centres, and Centres of Excellence; (h) Auditing Member States\u2019 preparedness and response arrangements, for example regarding health crisis management, antimicrobial resistance and vaccination; (i) Communicating to the public in the context of risk management and health crisis preparedness; (j) Supporting upwards convergence of national systems\u2019 performance through health indicator development, analysis and knowledge brokering and the organisation of voluntary stress tests of national healthcare systems; (k) Supporting investigation, risk assessment and risk management work on the link between animal health, environmental factors, and human diseases, including during health crises. 3. Actions meeting the objective laid down in point (c) of Article 4 (a) Supporting actions to strengthen laboratory capacity and the production, research, development, and deployment of health products and crisis-relevant niche products within the Union; (b) Supporting actions and interoperable IT tools to monitor, prevent, manage, report and notify shortages of medicinal products and medical devices, while contributing to their affordability; (c) Supporting, in synergy with other programmes, clinical trials to speed up the development, market authorisation and access to innovative, safe and effective medicinal products and vaccines; (d) Supporting actions to encourage the development of innovative medicinal products and vaccines to meet rising healthcare challenges and patients\u2019 needs, and of less commercially profitable products such as antimicrobials; (e) Supporting actions to improve the environmentally friendly production and disposal of medicinal products and medical devices and actions to support the development of medicinal products that are less harmful for the environment; (f) Supporting actions to promote the prudent and efficient use of medicinal products, in particular of antimicrobials; (g) Supporting actions aimed at stimulating the increase in the production of essential active pharmaceutical ingredients and medicinal products in the Union, including by diversifying supply chain production of active pharmaceutical ingredients and generics within the Union, to reduce Member States\u2019 dependence on certain third countries; (h) Supporting actions to enhance the availability, accessibility and affordability of medicinal products and medical devices; (i) Supporting actions to foster innovation in repurposing, reformulation and combining of off-patent medicinal products, in synergy with other programmes; (j) Actions to strengthen the environmental risk assessment of medicinal products; (k) Supporting the establishment and operation of a mechanism for cross-sectorial coordination following the One-Health approach. 4. Actions meeting the objective laid down in point (d) of Article 4 (a) Monitoring of information on national stockpiling activities regarding essential crisis-relevant products to identify potential needs for additional stockpiling at Union level; (b) Ensuring consistent management of stockpiling of essential crisis-relevant products at Union level, in a manner that complements other Union instruments, programmes and funds and in close coordination with relevant Union bodies; (c) Supporting actions for the procurement and supply of essential crisis-relevant products, which contribute to their affordability, in a manner that complements Member States\u2019 stockpiling actions. 5. Actions meeting the objective laid down in point (e) of Article 4 Supporting actions for the preparatory work for mobilising and training at Union level a reserve of medical, healthcare and support staff to be mobilised in the event of a health crisis, in close collaboration with the ECDC, in synergy with other Union instruments, and in full respect of Member State competences; facilitating the exchange of best practices between existing national reserves of medical, healthcare and support staff. 6. Actions meeting the objective laid down in point (f) of Article 4 (a) Supporting a Union framework and the respective interoperable digital tools for cooperation among Member States and cooperation in networks, including those needed for HTA cooperation; (b) Supporting the deployment, operation and maintenance of mature, secure and interoperable digital service infrastructure and data quality assurance processes for the exchange of, access to, and use and reuse of, data; supporting cross-border networking, including through the use and interoperability of electronic health records, registries and other databases; developing appropriate governance structures and interoperable health information systems; (c) Supporting the digital transformation of healthcare and health systems, including through benchmarking and capacity building, for the uptake of innovative tools and technologies such as artificial intelligence, and supporting the digital upskilling of healthcare professionals; (d) Supporting the optimal use of telemedicine and telehealth, including through satellite communication for remote areas, fostering digitally-driven organisational innovation in healthcare facilities and promoting digital tools to support citizen empowerment and patient-centred care; (e) Supporting the development, operation and maintenance of databases and digital tools and their interoperability, including already established projects, where appropriate, with other sensing technologies, such as space-based technologies and artificial intelligence; (f) Supporting actions to strengthen citizens\u2019 access to and control over their health data; (g) Supporting the deployment and interoperability of digital tools and infrastructure within and between Member States and with Union institutions, agencies and bodies; (h) Supporting preparatory activities and projects for the European health data space; (i) Actions to support e-health, such as the transition to telemedicine and at-home administration of medication; (j) Supporting the establishment of interoperable electronic health records, in line with the European Electronic Health Record Exchange format in order to increase the use of e-health and improve the sustainability and resilience of healthcare systems. 7. Actions meeting the objective laid down in point (g) of Article 4 (a) Actions promoting access to health services and related facilities and care for people with disabilities; (b) Supporting the strengthening of primary care and reinforcing the integration of care, with a view to providing universal health coverage and equal access to good quality healthcare; (c) Supporting Member States\u2019 actions to promote access to sexual and reproductive healthcare and supporting integrated and intersectional approaches to prevention, diagnosis, treatment and care. 8. Actions meeting the objective laid down in point (h) of Article 4 (a) Supporting the establishment and operation of a health intelligence and knowledge infrastructure; (b) Supporting the implementation, enforcement, monitoring of Union health legislation and action; and providing technical support for the implementation of legal requirements; (c) Supporting studies and analysis, health impact assessment of other Union policy actions and the provision of scientific advice to support evidence-based policymaking; (d) Supporting expert groups and panels providing advice, data and information to support health policy development and implementation, including follow-up evaluations of the implementation of health policies; (e) Supporting national contact and focal points in providing guidance, information and assistance related to the promotion and implementation of Union health legislation and of the Programme; (f) Auditing and assessment work in accordance with Union legislation, where appropriate; (g) Supporting the implementation and further development of the Union\u2019s tobacco control policy and legislation; (h) Supporting national systems as regards the implementation of legislation on substances of human origin, and as regards the promotion of the sustainable and safe supply of such substances through networking activities; (i) Supporting Member States to strengthen the administrative capacity of their healthcare systems through cooperation and exchange of best practices; (j) Supporting knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience of health systems, while linking available Union funding; (k) Supporting capacity building for investing in and implementing health system reforms, including strategic planning and access to multi-source financing. 9. Actions meeting the objective laid down in point (i) of Article 4 (a) Supporting the transfer, adaptation and roll-out of best practices and innovative solutions with established Union level added-value between Member States, and in particular providing country-specific tailor-made assistance to the Member States, or groups of Member States, with the greatest needs, through the funding of specific projects including twinning, expert advice and peer support; (b) Supporting cross-border collaboration and partnerships, including in cross-border regions, with a view to transferring and upscaling innovative solutions; (c) Strengthening cross-sectoral collaboration and coordination; (d) Supporting the functioning of ERNs and the establishment and operation of new transnational networks as provided for in Union health legislation, and supporting Member States\u2019 actions to coordinate the activities of such networks with the operation of national health systems; (e) Supporting further the implementation of ERNs in Member States and fostering their strengthening, inter alia, by continuous assessment, monitoring, evaluation and improvement; (f) Supporting the creation of new ERNs, to cover rare, complex and low prevalence diseases, where appropriate, and supporting collaboration among ERNs to address the multi-systemic needs arising from low prevalence diseases and rare diseases and to facilitate diagonal networking between different specialities and disciplines; (g) Support Member States to improve and further develop and implement ERN registries; (h) Stakeholder consultation activities. 10. Actions meeting the objective laid down in point (j) of Article 4 (a) Supporting actions contributing to the objectives of the programme presented by the WHO, as the directing and coordinating authority for health within the United Nations; (b) Supporting collaboration among Union institutions, Union agencies, and international organisations and networks, and supporting the Union\u2019s contribution to global initiatives; (c) Supporting collaboration with third countries as regards the areas covered by the Programme; (d) Supporting actions to foster international regulatory convergence on medicinal products and medical devices. ANNEX II INDICATORS FOR THE EVALUATION OF THE PROGRAMME Programme indicators: 1. Preparedness and response planning of the Union and of Member States for serious cross-border threats to health 2. Access to centrally authorised medicinal products, for example the number of existing and new orphan authorisations, advanced therapy medicinal products (ATMPs), medicinal products for paediatric use or vaccines, for unmet needs 3. Number of actions contributing to the reduction of avoidable mortality in the area of non-communicable diseases and risk factors 4. Number of Member States implementing best practices regarding health promotion, disease prevention and addressing health inequalities 5. Number of Member States participating in the European health data space 6. Number of Member States with improved preparedness and response planning 7. Vaccination coverage by age for vaccine-preventable-diseases such as measles, flu, HPV and COVID-19 8. EU Laboratory capacity index (EULabCap) 9. Age-standardised five-year net survival rate for paediatric cancer by type, age, gender and Member State (to the extent available) 10. Screening coverage for breast, cervical and colorectal cancer screening programmes, by type, target population, and Member State 11. Percentage of population covered by Cancer Registries and number of Member States reporting information on cervical, breast, colorectal and paediatric cancer stage at diagnosis 12. Number of actions addressing the prevalence of major chronic diseases per Member State, by disease, gender and age 13. Number of actions addressing the age prevalence of tobacco use, if possible differentiated by gender 14. Number of actions addressing the prevalence of harmful use of alcohol, if possible differentiated by gender and age 15. Number of shortages of medicinal products in the Member States as reported through the single point of contact network 16. Number of actions aimed at increasing the security and continuity of the global supply chains and addressing dependence on imports from third countries for the production of essential active pharmaceutical ingredients and medicinal products in the Union 17. Number of audits conducted in the Union and in third countries to ensure good manufacturing practices and good clinical practices (Union control) 18. Antimicrobial consumption for systemic use ATC (group J01) per Member State 19. Number of healthcare units involved in ERNs and of patients diagnosed and treated by the members of ERNs 20. Number of HTA reports jointly carried out 21. Number of health impact assessments of Union policies 22. Number of actions addressing the fight against communicable diseases 23. Number of actions addressing environmental risk factors for health", "summary": "EU4Health Programme (2021-2027) EU4Health Programme (2021-2027) SUMMARY OF: Regulation (EU) 2021/522 establishing a Programme for the EU\u2019s action in the field of health (EU4Health Programme) for the period 2021-2027 WHAT IS THE AIM OF THE REGULATION? It establishes the EU4Health programme which, like the European Union (EU)\u2019s multiannual financial framework (MFF), runs from 2021 to 2027. It sets out the programme\u2019s: general and specific objectives; forms and rules of EU funding. KEY POINTS The programme brings EU added value, creating efficiency gains and value-added impacts that could not be achieved by actions taken only at national level. It supports and complements national policies to promote and improve human health in Europe and ensures human health protection in all EU policies and activities in line with the One Health approach*. The 4 general objectives are to: improve and foster health in the EU; protect people from serious cross-border health threats; improve medicines, medical devices and crisis-relevant products; strengthen health systems by improving their resilience and resource efficiency. These are implemented through 10 specific objectives as follows: to improve and foster health in the EU, the programme will support disease prevention and health promotioninternational health initiatives and cooperation; to reinforce EU Member States and the EU\u2019s abilities to tackle cross-border health threats, the programme will support prevention, preparedness and response to cross-border health threatscomplementing national stockpiling of essential crisis-relevant productssetting up a reserve of medical, healthcare and support staff; to contribute to responding to the rising demand for healthcare and to fairer public health protection by supporting the improved availability, accessibility and affordability of medicinal products, medical devices and crisis-relevant products; to improve the resilience and resource efficiency of health systems, EU4Health will support actions that contribute to strengthening health data, digital tools and services, and the digital transformation of healthcareenhancing access to healthcaredeveloping and implementing EU health legislation and evidence-based decision-makingintegrated work among Member States\u2019 health systems. Annex I to the regulation lists the many different activities eligible for EU funding under each of the 10 specific objectives. Recipients must acknowledge and ensure visibility of the EU finance they receive. In cases of a serious cross-border threat to health or a public health emergency, procurement under the programme may take the following forms and the European Commission may: jointly procure with Member States when they acquire, rent or lease fully the items procured; carry on procurement on behalf of Member States on the basis of an agreement; procure as a wholesaler buying, stocking and selling or donating supplies and services, for the benefit of the Member States and selected partner organisations. The 7-year programme\u2019s budget is \u20ac2,446,000,000 (current prices). This is increased by an additional \u20ac2,900,000,000 (2018 prices) from the MFF. The total \u20ac5.3 billion of funds are distributed according to the following criteria: health promotion and disease prevention: minimum of 20%; procurement to complement national stockpiling of essential crisis products: maximum of 12.5%; global commitments and health initiatives: maximum of 12.5%; administrative expenses: maximum of 8%. The programme may provide funding in any of the forms laid down in the Financial Regulation, in particular in the form of grants, prizes and procurement. Grants should not exceed 60% of a project\u2019s eligible costs, but this may rise to 80% where there is \u2018exceptional utility\u2019, as defined in Article 8. The grants may finance 100% of the eligible costs for actions of European Reference Networks (ERNs) or other transnational networks defined by EU law and, under certain conditions, for actions of the World Health Organisation (WHO). Non-EU countries may take part in the programme under certain conditions and only if they are associated with the programme. Governance rules provide for a consultative EU4Health steering groupcomposed of Commission and national representatives. This: ensures consistency and complementarity between national health policies, and between the programme and other EU measures; follows the programme\u2019s implementation, proposing any necessary adjustments; meets at least 3 times a year so Member States can exchange views. The Commission is assisted by a EU4Health Programme Committee, which gives an opinion prior the adoption of the annual work programme by the Commission. If the Committee has no opinion or a negative opinion, the Commission cannot adopt the work programme. The Commission: consults the steering group when preparing the annual work programmes and informs the European Parliament before the last meeting of the steering group on the outcome of those meetings; seeks the views of relevant stakeholders, including civil society and patient organisations on the annual work programme\u2019s priorities and strategic orientation as well as on the needs to be addressed and the achieved results; implements EU4Health through annual work programmes, which it adopts after a positive opinion of the Member States in the Programme Committee; will present an interim evaluation of the programme no later than 31 December 2024 and a final evaluation no later than the end of 2031 to the European Parliament, Council, European Economic and Social Committee and the Committee of the Regions; is assisted by an EU4Health Programme Committee; implements information and communication campaigns about the programme; has the power to adopt implementing and delegated acts. Annex II sets out the 23 indicators used to evaluate the programme\u2019s progress. The regulation repeals Regulation (EU) No 282/2014 from 1 January 2021 with transitional rules to cover the transition to EU4Health. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND EU4Health is the EU\u2019s response to the COVID-19 pandemic which has had a major impact on patients, medical and healthcare staff and health systems in Europe. It goes further than crisis response, to strengthen the resilience of healthcare systems with a strong focus on long-term health issues. For more information, see: EU4Health 2021-2027 \u2014 a vision for a healthier European Union (European Commission). KEY TERMS One Health approach: an approach which recognises that human health is closely linked to that of animals and the environment. MAIN DOCUMENT Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union\u2019s action in the field of health (\u2018EU4Health Programme\u2019) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, pp. 1-29) RELATED DOCUMENTS Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients\u2019 rights in cross-border healthcare (OJ L 88, 4.4.2011, pp. 45-65) Successive amendments to Directive 2011/24/EU have been incorporated into the original text. This consolidated version is of documentary value only. last update 06.09.2021"}
{"article": "28.5.2021 EN Official Journal of the European Union L 189/34 REGULATION (EU) 2021/818 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 May 2021 establishing the Creative Europe Programme (2021 to 2027) and repealing Regulation (EU) No 1295/2013 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular, Article 167(5), and Article 173(3) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Culture, arts, cultural heritage and cultural diversity are of great value to European society from a cultural, educational, democratic, environmental, social, human rights and economic point of view and should be promoted and supported. The Rome Declaration of 25 March 2017 and the European Council of 14 and 15 December 2017 stated that education and culture are key to building inclusive and cohesive societies for all and to sustaining European competitiveness. (2) Pursuant to Article 2 of the Treaty on European Union (TEU), the Union is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and the respect for human rights, including the rights of persons belonging to a minority. Those values are common to the Member States in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail. Those values are further reaffirmed and articulated in the rights, freedoms and principles enshrined in the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019), which has the same legal value as the Treaties under Article 6 TEU. In particular, the freedom of expression and information and the freedom of the arts and science are enshrined, respectively, in Articles 11 and 13 of the Charter. (3) Article 3 TEU further specifies that the Union\u2019s aim is to promote peace, its values and the well-being of its peoples and that, inter alia, it is to respect its rich cultural and linguistic diversity and ensure that Europe\u2019s cultural heritage is safeguarded and enhanced. (4) The communication of the Commission of 22 May 2018 entitled \u2018A New European Agenda for Culture\u2019 sets out objectives for the cultural and creative sectors. It aims to harness the power of culture and cultural diversity for social cohesion and societal well-being by fostering the cross-border dimension of cultural and creative sectors and fostering their capacity to grow, to encourage culture-based creativity in education and innovation, and for jobs and growth, and to strengthen international cultural relations. The Creative Europe Programme (the \u2018Programme\u2019), together with other Union programmes and funds, will support the New European Agenda for Culture. The intrinsic value of culture and of artistic expression should be preserved and promoted, and artistic creation should be at the heart of the Programme. That is also consistent with the 2005 Unesco Convention on the Protection and Promotion of the Diversity of Cultural Expressions, which entered into force on 18 March 2007 and to which the Union and its Member States are parties. (5) In order to foster the shared area of cultural diversity for the peoples of Europe, it is important to promote the transnational circulation of artistic and cultural works, collections and products, thereby encouraging dialogue and cultural exchanges, and the transnational mobility of artists and of cultural and creative professionals. (6) Safeguarding and enhancing cultural heritage facilitates free participation in cultural life, in line with the United Nations (UN) Universal Declaration of Human Rights and the International Covenant on Economic, Social and Cultural Rights. Therefore, cultural heritage plays an important role in the construction of a peaceful and democratic society, in processes of sustainable development and in the promotion of cultural diversity. (7) The promotion of European cultural diversity is based on the freedom of artistic expression, the capabilities and competences of artists and cultural operators, the existence of flourishing and resilient cultural and creative sectors and the ability of artists and cultural operators to create, innovate and produce their works and distribute them to a larger and more diverse European audience. This thereby enlarges the business potential of the cultural and creative sectors, increases access to and the promotion of creative content, artistic research and creativity, and contributes to sustainable growth and job creation. In addition, the promotion of creativity and new knowledge contributes to boosting competitiveness and sparking innovation in industrial value chains. The Union\u2019s rich cultural and linguistic diversity is a key asset for the European project. At the same time, the European cultural and creative market is characterised by geographical specificities, linguistic specificities, or both, which can cause market fragmentation. Continuing efforts are therefore required to ensure that the cultural and creative sectors fully benefit from the Union\u2019s single market and, in particular, from the Digital Single Market. (8) The digital shift represents a paradigm change for cultural and creative sectors. It has reshaped habits, relations, and production and consumption models. This presents a number of challenges. At the same time, the digital shift offers new opportunities for cultural and creative sectors in terms of the creation of, distribution of and access to European works, which benefits European society as a whole. The Programme should encourage cultural and creative sectors to take advantage of those opportunities. (9) The Programme should take into account the dual nature of the cultural and creative sectors, recognising, on the one hand, the intrinsic and artistic value of culture and, on the other, the economic value of those sectors, including the broader contribution of those sectors to growth, competitiveness, creativity and innovation. The Programme should also take into account the positive impact of culture on intercultural dialogue, social cohesion and the dissemination of knowledge. This requires strong European cultural and creative sectors, in particular a vibrant European audiovisual industry, given its capacity to reach diverse audiences and its economic importance, including its economic importance for other creative sectors. However, competition in global audiovisual markets has been further intensified by the deepening digital shift, for example changes in media production and consumption and the growing position of global platforms in the distribution of content. Therefore, there is a need to step up support for the European industry. (10) As exemplified by the Union action for the European Capitals of Culture, established by Decision No 445/2014/EU of the European Parliament and of the Council (4) (the \u2018European Capitals of Culture\u2019), the cultural and creative sectors have an important role in enhancing and revitalising the Union\u2019s territories. In that way, the cultural and creative sectors are key drivers for boosting quality-based tourism and regional, local and urban development across the Union. (11) In order to be effective, the Programme should take into account the specific nature and challenges of the different cultural and creative sectors, their different target groups and their particular needs through tailor-made approaches within a strand dedicated to the audiovisual sector (the \u2018Media strand\u2019), a strand dedicated to the other cultural and creative sectors (the \u2018Culture strand\u2019) and a cross-sectoral strand (the \u2018Cross-sectoral strand\u2019). (12) The Programme should support actions and activities with European added value, which complement regional, national, international and other Union programmes and policies and positively impact European citizens, and should support the development and promotion of transnational cooperation and exchanges within the cultural and creative sectors. Through such actions and activities, the Programme contributes to the strengthening of European identity and values while promoting cultural and linguistic diversity. (13) Music, in all its forms and expressions, and in particular contemporary and live music, is an important component of the cultural, artistic and economic landscape of the Union and its heritage. It is an element of social cohesion and it serves as a key instrument to enhance economic and cultural development. The Culture strand should therefore pay attention to the music sector. (14) The Culture strand should promote the networking of creative communities and foster cross-border and multi-disciplinary collaboration with the use of different skillsets, such as artistic, creative, digital and technological skillsets. (15) The Cross-sectoral strand aims to exploit the potential of collaboration among different cultural and creative sectors and to address the common challenges they face. There are benefits in terms of knowledge transfer and administrative efficiencies to be gained from a joint transversal approach. In that context, the Programme desks contribute to the achievement of the objectives of the Programme and its implementation. (16) Union intervention is needed in the audiovisual sector to accompany the Union\u2019s Digital Single Market policies. That concerns, in particular, the modernisation of the copyright framework by means of Directives (EU) 2019/789 (5) and (EU) 2019/790 (6) of the European Parliament and of the Council, and Directive 2010/13/EU of the European Parliament and of the Council (7), as amended by Directive (EU) 2018/1808 of the European Parliament and of the Council (8). Directives (EU) 2019/789 and (EU) 2019/790 seek to strengthen the capacity of European audiovisual operators to create, finance, produce and disseminate works that are prominently displayed on different media, for example TV, cinema or Video On Demand, that are available and attractive to audiences in a more open and competitive market within Europe and beyond. Those Directives also aim to achieve a well-functioning market place for creators and right holders, especially for press publications and online platforms, and to ensure fair remuneration of authors and performers, which are dimensions that should be taken into account across the Programme. Furthermore, support should be scaled up in order to address recent market developments, in particular the stronger position of global platforms of distribution in comparison to national broadcasters that traditionally invest in the production of European works. As the market conditions and audiovisual operators continue to evolve, specific criteria to define what constitutes an independent production company should be provided in the context of the implementation of the Programme. (17) The Programme should allow for the broadest possible participation of organisations in the cultural and creative sectors in it and for those organisations to access the Programme in the broadest way possible, regardless of their geographical origin. The Programme should support those organisations and the best talent, wherever located, to operate across borders and internationally. The Media strand should take into account the differences across countries regarding the production and distribution of audiovisual content and access to audiovisual content and trends relating to the consumption of audiovisual content, and, in particular, their linguistic and geographical specificities, thereby providing a more level playing field, broadening the participation of, and increasing collaboration among, Member States with different audiovisual capacities and supporting European talent, wherever located, to operate across borders and internationally. The specificities of the outermost regions referred to in Article 349 of the Treaty on the Functioning of the European Union (TFEU) should also be taken into account. (18) The special actions under the Programme such as the Union action for the European Heritage Label established by Decision No 1194/2011/EU of the European Parliament and of the Council (9) (the \u2018European Heritage Label\u2019), the European Heritage Days, European prizes in the areas of contemporary, rock and pop music, literature, heritage and architecture and the European Capitals of Culture have directly reached millions of European citizens, have demonstrated the social and economic benefits of European cultural policies, and should therefore be continued and whenever possible expanded. The Culture strand should support the networking activities of the European Heritage Label sites. Consideration should also be paid to the possibility of extending the European prizes to new fields and sectors, notably theatre. (19) Culture is key to strengthening inclusive and cohesive communities. In the context of migration issues and integration challenges, culture plays a fundamental role in providing opportunities for intercultural dialogue and in integrating migrants and refugees, helping them to feel part of host societies, and in developing good relations between migrants and new communities. (20) In order to contribute to an inclusive society, the Programme should promote and increase cultural participation across the Union, in particular with regard to people with disabilities and people from disadvantaged backgrounds. (21) In accordance with the Davos Declaration of 22 January 2018 entitled \u2018Towards a high-quality Baukultur for Europe\u2019, steps should be taken to promote a new integrated approach to the shaping of a high-quality built environment which is anchored in culture, which strengthens social cohesion, which guarantees a sustainable environment and which contributes to the health and well-being of the population as a whole. That approach should not only place an emphasis on urban areas, but also on the interconnectivity of peripheral and rural areas. The concept of Baukultur encompasses all factors which have a direct impact on the quality of life of citizens and communities, thereby fostering inclusivity, cohesion and sustainability in a very concrete way. (22) Freedom of expression and artistic freedom are at the core of vibrant cultural and creative sectors. In particular, the news media sector needs a free, diverse and pluralistic media environment. In conjunction with Directive 2010/13/EU, the Programme should therefore promote a free, diverse and pluralistic media environment, encouraging crossovers and cross-cutting activities supporting the news media sector. The Programme should provide support for new media professionals and enhance the development of critical thinking among citizens by means of promoting media literacy. (23) The Programme should also stimulate interest in and improve access to European audiovisual works, in particular through audience development measures, including film literacy. (24) The mobility of artists and cultural workers beyond borders under the Culture strand can contribute to better linked, stronger and more sustainable cultural and creative sectors in the Union because this is a way to accelerate the development of skills and the learning curve within the cultural and creative sectors, to improve intercultural awareness and to foster the transnational co-creation, co-production, circulation and dissemination of works. (25) Cooperation projects, in particular small-scale projects, given the specificities of the cultural and creative sectors, should be at the core of the Culture strand. Therefore, the Commission should facilitate participation in the Programme by achieving substantial simplification of bureaucratic procedures, mostly in the application stage, and, for small-scale projects, by allowing higher co-financing rates. (26) In line with Articles 8 and 10 TFEU, the Programme, in all its activities, should support gender mainstreaming and the mainstreaming of non-discrimination objectives and should, where applicable, define appropriate gender-balance criteria. Women are actively engaged in cultural and creative sectors as authors, professionals, teachers, artists and audience members. However, it is less likely that women occupy decision-making positions in cultural, artistic and creative institutions. Therefore, the Programme should promote female talent in order to support women\u2019s artistic and professional careers. (27) Taking into account the joint communication of 8 June 2016 entitled \u2018Towards an EU strategy for international cultural relations\u2019, endorsed by the resolution of the European Parliament of 5 July 2017 on the mandate for the trilogue on the 2018 draft budget (10), and the Council conclusions of 24 May 2017 on an EU strategic approach to international cultural relations, European funding instruments and, in particular, the Programme should recognise the relevance of culture in international relations and its role in promoting European values by dedicated and targeted actions designed to have a clear Union impact on the global scene. (28) In line with the communication of the Commission of 22 July 2014 entitled \u2018Towards an integrated approach to cultural heritage for Europe\u2019, relevant policies and instruments should ensure the legacy of the 2018 European Year of Cultural Heritage, which successfully and efficiently mainstreamed culture into other policy fields, in particular through a participatory governance approach, in drawing out the long term and sustainability value of Europe\u2019s cultural heritage, developing a more integrated approach to its preservation and valorisation and supporting the sustainable safeguarding, the regeneration, the adaptive reuse and the promotion of its values through awareness-raising and networking activities. In the culture sector, consideration should be given to supporting artists, creators and artistic craftspeople skilled in the traditional trades related to cultural heritage restoration. In the audiovisual sector, in particular, heritage works are a crucial source of memory and cultural diversity and represent potential market opportunities. In this context, audiovisual archives and libraries contribute to the preservation and re-use of, and new market developments for, heritage works. (29) In line with the communication of the Commission of 10 March 2020 entitled \u2018A New Industrial Strategy for Europe\u2019, the Union should rely on its strengths, in particular its diversity, its talents, its values, its way of life and its innovators and creators. (30) The success of the Programme relies on the development of innovative and effective projects that generate good practices in terms of transnational European cooperation in the cultural and creative sectors. Wherever possible, such success stories should be promoted, encouraging the support of new business models and skills, fostering traditional know-how and translating creative and interdisciplinary solutions into economic and social value. (31) The Programme should be open, subject to certain conditions, to the participation of Members of the European Free Trade Association, acceding countries, candidate countries and potential candidates benefiting from a pre-accession strategy, European Neighbourhood Policy countries and the Union\u2019s strategic partners. (32) Third countries which are members of the European Economic Area may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (11), which provides for the implementation of the programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, the European Anti-Fraud Office (OLAF) and the Court of Auditors to comprehensively exercise their respective competences. (33) Third countries should aim to participate fully in the Programme. However, third countries that do not fulfil the conditions for participating in the Media and Cross-sectoral strands but participate in the Culture strand should be able to set up and support Programme desks to promote the Programme in their country and to stimulate cross-border cooperation within the cultural and creative sectors. (34) Derogations from the obligation to fulfil the conditions set out in Directive 2010/13/EU should be subject to scrutiny and granted to European Neighbourhood Policy countries in duly justified cases, taking into account the specific situation of the audiovisual market in the country concerned and the level of integration in the European audiovisual policy framework. Progress towards the achievement of the objectives set out in Directive 2010/13/EU should be monitored on a regular basis. Moreover, participation in actions funded by the Media strand should be set out on a case-by-case basis in the relevant work programmes. (35) The Programme should foster the cooperation between the Union and international organisations such as Unesco, the Council of Europe, including Eurimages and the European Audiovisual Observatory (the \u2018Observatory\u2019), the Organisation for Economic Co-operation and Development (OECD) and the World Intellectual Property Organisation. The Programme should also support the Union commitment relating to the UN Sustainable Development Goals, in particular its cultural dimension. As regards the audiovisual sector, the Programme should ensure the Union\u2019s contribution to the work of the Observatory. (36) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement adopted under the United Nations Framework Convention on Climate Change and to achieve the UN Sustainable Development Goals, the Programme is intended to contribute to mainstreaming climate actions and to the achievement of an overall target of 30 % of Union budget expenditure supporting climate objectives. In line with the European Green Deal as a blueprint for sustainable growth, the actions under this Regulation should respect the \u2018do no harm\u2019 principle. During the implementation of the Programme, relevant actions should be identified and put in place without changing the fundamental character of the Programme, and should be reassessed in the context of the relevant evaluations and review process. (37) For simplification and efficiency, the Commission should be able to divide budgetary commitments into annual instalments. In that case, the Commission should commit the annual instalments during the Programme\u2019s implementation, taking into account the progress of the actions that receive financial assistance, their estimated needs and the budget available. The Commission should communicate to the beneficiaries of grants an indicative timetable covering the commitment of the individual annual instalments. (38) Horizontal financial rules adopted by the European Parliament and by the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (12) (the \u2018Financial Regulation\u2019) and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (39) \u2018LUX - the European Audience Film Award by the European Parliament and the European Film Academy\u2019 has established itself as a distinctive European prize, promoting and disseminating European films that reflect European identity and values beyond national borders, and building on collaborations with a community of renowned film creators and European film organisations and networks. (40) Since its creation, the European Union Youth Orchestra has developed a unique expertise in promoting access to music, as well as intercultural dialogue, mutual respect and understanding through culture, while also favouring the international career development and training of young musicians. The particularity of the European Union Youth Orchestra lies in the fact that it is a European orchestra, created by a resolution of the European Parliament, that transcends cultural boundaries and is composed of young musicians selected across Europe in accordance with demanding artistic criteria through a rigorous and transparent annual audition process in all Member States. This special contribution to Europe\u2019s cultural diversity and identity should be acknowledged by, for example, providing for actions in which the European Union Youth Orchestra and similar European cultural entities can apply to participate. The possibility of multiannual funding for such entities should be provided for in order to ensure the stability of their functioning. (41) Organisations in the cultural and creative sectors with a large European geographical coverage and whose activities entail delivering cultural services directly to the European citizens and that thus have the potential to have direct impact on European identity should be eligible for Union support. (42) In order to ensure the efficient allocation of funds from the general budget of the Union, it is necessary that all actions and activities carried out under the Programme provide European added value. It is also necessary to ensure that they complement Member States\u2019 activities. Consistency, complementarity and synergies should be sought with funding programmes that support policy areas with close links to each other, ensuring that potential beneficiaries are aware of the different funding opportunities, and with horizontal policies such as Union competition policy. (43) Financial support should be used to address market failures or sub-optimal investment situations in a proportionate manner, and actions should not duplicate or crowd out private financing or distort competition in the internal market. (44) It is important that the Programme address the structural challenges of Europe\u2019s cultural and creative sectors, which have been exacerbated by the COVID-19 pandemic. The Programme encompasses the fundamental role of European culture and media in citizens\u2019 well-being and in empowering them to take informed decisions. The Programme, together with other relevant Union funding programmes and Next Generation EU, should support the short-term recovery of the cultural and creative sectors, enhance their longer-term resilience and competitiveness in order to best address potential major crises in the future and accompany their digital and ecological transition. (45) The policy objectives of the Programme are also addressed through financial instruments and budgetary guarantees under the policy windows of the 2021-2027 Invest EU Programme established by Regulation (EU) 2021/523 of the European Parliament and of the Council (13), which, inter alia, continue to facilitate access to finance for small and medium-sized enterprises and organisations in the cultural and creative sectors. (46) Impact, quality and efficiency in the implementation of projects under the Programme should constitute key evaluation criteria for the selection of the projects in question. Taking into account the technical expertise required to assess proposals under specific actions of the Programme, members of committees to evaluate such proposals (\u2018evaluation committees\u2019) may be external experts. When selecting the external experts, due consideration should be paid to their professional backgrounds and to the gender balance of the committee in question. (47) The Programme should include a realistic and manageable system of qualitative and quantitative performance indicators to accompany its actions and to monitor its performance on a continuous basis. Such monitoring and information and communication actions relating to the Programme and its actions should build on the three strands of the Programme. (48) Considering the importance and complexity of gathering and analysing data and of measuring the impact of cultural policies, the Commission should help to gather evidence and statistical data on the trends and developments of the cultural and creative sectors by making use of its expertise and that of other relevant research institutions and should regularly report to the European Parliament and to the Council on the data gathered. (49) The Programme should be established for a period of seven years to align its duration with that of the multiannual financial framework for the years 2021 to 2027 laid down in Council Regulation (EU, Euratom) 2020/2093 (14) (the \u20182021-2027 MFF\u2019). (50) This Regulation lays down a financial envelope for the Programme which is to constitute the prime reference amount within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (15), for the European Parliament and the Council during the annual budgetary procedure. (51) The Financial Regulation applies to this Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, including those to third parties, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (52) The forms of funding and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the need for administrative simplification, in particular in the application process, for the benefit of all parties involved, and the expected risk of non-compliance. When making that choice, the use of lump sums, unit costs and flat rates, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation, should be considered. (53) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (16) and Council Regulations (EC, Euratom) No 2988/95 (17), (Euratom, EC) No 2185/96 (18) and (EU) 2017/1939 (19), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, OLAF has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (20). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (54) It should be possible to award quality proposals for actions that are eligible under the Programme but cannot be financed under it due to budgetary constraints with a Seal of Excellence label, based on a specific set of criteria. The Seal of Excellence label recognises the quality of the proposal and simplifies the search for alternative funding under the European Regional Development Fund or the European Social Fund Plus. For actions in respect of which a Seal of Excellence label could be awarded, additional information should be provided in the relevant calls for proposals. (55) In view of Article 349 TFEU, and taking into account the communication of the Commission of 24 October 2017 entitled \u2018A stronger and renewed strategic partnership with the EU\u2019s outermost regions\u2019, the specific contribution of the regions referred to in that Article to the cultural diversity of the Union, as well as their role in promoting exchanges of, including through mobility, and cooperation with people and organisations from third countries, in particular from their neighbouring countries, should be valued. Pursuant to Council Decision 2013/755/EU (21) and taking into account the contribution of overseas countries and territories to the international cultural influence of the Union, persons and entities established in overseas countries and territories are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. It should thus be possible for people to benefit equally from the competitive advantages that the cultural and creative industries can offer, in particular economic growth and employment. (56) In order to ensure the effective assessment of the Programme\u2019s progress towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of developing a monitoring and evaluation framework and of reviewing the Programme indicators. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (22). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (57) In accordance with Article 193(2) of the Financial Regulation, it is possible to award a grant for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible for Union financing, except in duly justified exceptional cases. In accordance with Article 193(4) of the Financial Regulation, the costs incurred prior to the date of submission of the grant application are also not eligible for Union financing in the case of operating grants and the grant agreement is to be signed within four months of the start of the beneficiary\u2019s financial year. In order to avoid any disruption in Union support which could be prejudicial to Union\u2019s interests, it should be possible to provide in the financing decision, for a limited period of time at the beginning of the 2021-2027 MFF, and only in duly justified cases, for the eligibility of activities and costs from 1 January 2021, even if those activities were implemented and those costs incurred before the grant application was submitted. (58) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Programme on the ground. (59) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt the work programmes. Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (23). In particular, as provided for by this Regulation, time limits should be proportionate and should afford committee members early and effective opportunities to examine the draft implementing act and express their views. (60) It is necessary to ensure that the 2014-2020 Creative Europe Programme established by Regulation (EU) No 1295/2013 of the European Parliament and of the Council (24) (the \u20182014-2020 Programme\u2019) is closed correctly, in particular as regards the continuation of multiannual arrangements for its management, such as the financing of technical and administrative assistance. As from 1 January 2021, technical and administrative assistance should ensure, where necessary, the management of actions that have not yet been finalised under the 2014-2020 Programme by 31 December 2020. (61) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter. In particular, this Regulation seeks to ensure full respect for the right to equality between men and women and the right to non-discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, as enshrined in Articles 21 and 23 of the Charter. This Regulation is also in line with the UN Convention on the Rights of Persons with Disabilities. (62) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of their transnational character, the high volume and wide geographical scope of the mobility and cooperation activities funded, their effects on access to learning mobility and more generally on Union integration, and their reinforced international dimension, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (63) Regulation (EU) No 1295/2013 should therefore be repealed with effect from 1 January 2021. (64) In order to ensure continuity in providing support in the relevant policy area and to allow the implementation to start from the beginning of the 2021-2027 MFF, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the Creative Europe Programme (the \u2018Programme\u2019) for the duration of the 2021-2027 MFF. It lays down the objectives of the Programme, the budget for the period from 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018cultural and creative sectors\u2019 means all sectors: (a) whose activities, many of which have potential to generate innovation and jobs in particular from intellectual property: (i) are based on cultural values and artistic and other individual or collective creative expressions; and (ii) include the development, the creation, the production, the dissemination and the preservation of goods and services which embody cultural, artistic or other creative expressions, as well as related functions such as education or management; (b) irrespective of: (i) whether the activities of those sectors are market-oriented or non-market-oriented; (ii) the type of structure that carries out those activities; and (iii) how that structure is financed; those sectors include, inter alia, architecture, archives, libraries and museums, artistic crafts, audiovisual (including film, television, video games and multimedia), tangible and intangible cultural heritage, design (including fashion design), festivals, music, literature, performing arts (including theatre and dance), books and publishing, radio, and visual arts; (2) \u2018legal entity\u2019 means a natural person or a legal person which is created and recognised as such under national law, Union law or international law, which has legal personality and which may exercise rights and be subject to obligations when acting in its own name, or an entity which does not have legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (3) \u2018blending operation\u2019 means actions supported by the Union budget, including within blending facilities pursuant to Article 2(6) of the Financial Regulation, that combine non-repayable forms of support and financial instruments from the Union budget with repayable forms of support from development or other public finance institutions, or from commercial finance institutions and investors. Article 3 Programme objectives 1. The general objectives of the Programme are to: (a) safeguard, develop and promote European cultural and linguistic diversity and heritage; (b) increase the competitiveness and the economic potential of the cultural and creative sectors, in particular the audiovisual sector. 2. The Programme has the following specific objectives: (a) to enhance artistic and cultural cooperation at the European level in order to support the creation of European works and strengthen the economic, social and external dimension of and innovation and mobility in Europe\u2019s cultural and creative sectors; (b) to promote competitiveness, scalability, cooperation, innovation and sustainability, including through mobility, in the European audiovisual sector; (c) to promote policy cooperation and innovative actions supporting all strands of the Programme and to promote a diverse, independent and pluralistic media environment, and media literacy, thereby fostering freedom of artistic expression, intercultural dialogue and social inclusion. 3. The Programme shall cover the following strands: (a) the Culture strand, which covers cultural and creative sectors with the exception of the audiovisual sector; (b) the Media strand, which covers the audiovisual sector; (c) the Cross-sectoral strand, which covers actions across all cultural and creative sectors. 4. Recognising the intrinsic and economic value of culture, the Programme objectives shall be pursued through actions with European added value. European added value shall be ensured, inter alia, through: (a) the transnational character of actions and activities, which complement regional, national, international and other Union programmes and policies, thereby promoting European common roots and cultural diversity; (b) cross-border cooperation, including through mobility, among organisations and professionals in the cultural and creative sectors, and the potential of such cooperation to address common challenges, including the digital shift, and to promote access to culture, active engagement of citizens and intercultural dialogue; (c) the economies of scale and growth and jobs which Union support fosters, creating a leverage effect for additional funds; (d) providing a more level playing field through actions with European added value under the Media strand that take into account the specificities of different countries, in particular regarding the production and distribution of content, access to content, the size and specificities of their markets and their cultural and linguistic diversity, in a way that broadens the participation of countries with different audiovisual capacities and strengthens collaboration between those countries. 5. The Programme objectives shall be pursued in a way that encourages inclusion, equality, diversity and participation, which, where appropriate, shall be achieved through specific incentives that: (a) ensure that people with disabilities, people belonging to minorities and people belonging to socially marginalised groups have access to the cultural and creative sectors and that encourage their active participation in those sectors, including in both the creative process and audience development; and (b) foster gender equality, in particular as a driver of creativity, economic growth and innovation. Article 4 Programme actions The Programme shall support actions that are in accordance with the priorities set out in Articles 5, 6 and 7 and the descriptions set out in Annex I. Article 5 Culture strand 1. In line with the Programme objectives referred to in Article 3, the Culture strand shall have the following priorities: (a) to strengthen transnational cooperation and the cross-border dimension of the creation, circulation and visibility of European works and the mobility of operators in the cultural and creative sectors; (b) to increase access to and participation in culture and to increase audience engagement and improve audience development across Europe; (c) to promote societal resilience and to enhance social inclusion and intercultural dialogue through culture and cultural heritage; (d) to enhance the capacity of the European cultural and creative sectors, including the capacity of individuals working in those sectors, to nurture talent, to innovate, to prosper and to generate jobs and growth; (e) to strengthen European identity and values through cultural awareness, arts education and culture-based creativity in education; (f) to promote capacity-building within the European cultural and creative sectors, including grassroots organisations and micro-organisations, so that they are able to be active at the international level; (g) to contribute to the Union\u2019s global strategy for international relations through culture. 2. The actions through which the priorities set out in paragraph 1 of this Article are to be pursued are set out in Section 1 of Annex I. Article 6 Media strand 1. In line with the Programme objectives referred to in Article 3, the Media strand shall have the following priorities: (a) to nurture talent, competence and skills and to stimulate cross-border cooperation, mobility, and innovation in the creation and production of European audiovisual works, thereby encouraging collaboration across Member States with different audiovisual capacities; (b) to enhance the circulation, promotion, online distribution and theatrical distribution of European audiovisual works within the Union and internationally in the new digital environment, including through innovative business models; (c) to promote European audiovisual works, including heritage works, and to support the engagement and development of audiences of all ages, in particular young audiences, across Europe and beyond. 2. The priorities set out in paragraph 1 of this Article shall be addressed through support for the development, production, promotion, and dissemination of European works and support for access to those works, with the objective of reaching diverse audiences within Europe and beyond, thereby adapting to new market developments and accompanying the implementation of Directive 2010/13/EU. 3. The actions through which the priorities set out in paragraph 1 of this Article are to be pursued are set out in Section 2 of Annex I. Article 7 Cross-sectoral strand 1. In line with the Programme objectives referred to in Article 3, the Cross-sectoral strand shall have the following priorities: (a) to support cross-sectoral transnational policy cooperation, including cooperation on the promotion of the role of culture in social inclusion and cooperation on artistic freedom, to promote the visibility of the Programme and to support the transferability of the results of the Programme; (b) to encourage innovative approaches to the creation, distribution and promotion of, and access to, content across cultural and creative sectors and other sectors, including by taking into account the digital shift, covering both market and non-market dimensions; (c) to promote cross-sectoral activities that aim at adjusting to the structural and technological changes faced by the media, including enhancing a free, diverse, and pluralistic media environment, quality journalism and media literacy, including in the digital environment; (d) to support the establishment of Programme desks in participating countries and the activities of Programme desks and to stimulate cross-border cooperation and the exchange of best practices within the cultural and creative sectors. 2. The actions through which the priorities set out in paragraph 1 of this Article are to be pursued are set out in Section 3 of Annex I. Article 8 Budget 1. The financial envelope for the implementation of the Programme for the period from 1 January 2021 to 31 December 2027 shall be EUR 1 842 000 000 in current prices. 2. As a result of the programme-specific adjustment provided for in Article 5 of Regulation (EU, Euratom) 2020/2093, the amount set out in paragraph 1 of this Article shall be increased by an additional allocation of EUR 600 000 000 in 2018 prices as specified in Annex II to that Regulation. 3. The indicative distribution of the amount set out in paragraph 1 of this Article shall be: (a) at least 33 % for the objective referred to in point (a) of Article 3(2) (Culture strand); (b) at least 58 % for the objective referred to in point (b) of Article 3(2) (Media strand); (c) up to 9 % for the objective referred to in point (c) of Article 3(2) (Cross- sectoral strand). 4. The indicative distribution of the amount set out in paragraph 2 of this Article shall be: (a) at least 33 % for the objective referred to in point (a) of Article 3(2) (Culture strand); (b) at least 58 % for the objective referred to in point (b) of Article 3(2) (Media strand); (c) up to 9 % for the objective referred to in point (c) of Article 3(2) (Cross-sectoral strand). 5. The amounts set out in paragraphs 1 and 2 may be used for technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities, including corporate information technology systems. 6. In addition to the amounts set out in paragraphs 1 and 2 of this Article, and in order to promote the international dimension of the Programme, additional financial contributions may be made available from a Regulation of the European Parliament and of the Council establishing the Neighbourhood, Development and International Cooperation Instrument \u2013Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009, and from a Regulation of the European Parliament and of the Council establishing the Instrument for Pre-accession Assistance (IPA III) to support actions that are implemented and managed in accordance with this Regulation. Such contributions shall be financed in accordance with the Regulations establishing those instruments. 7. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme subject to the conditions set out in Article 26 of a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the \u2018Common Provisions Regulation for 2021-2027\u2019). The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. 8. Budgetary commitments for actions extending over more than one financial year may be broken down over several years into annual instalments. Those commitments shall not exceed 40 % of the amount set out in paragraph 1. Article 9 Third countries associated to the Programme 1. The Programme shall be open to the participation of the following third countries, provided that they contribute financially to the Programme: (a) Members of the European Free Trade Association which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country a decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. The contributions referred to in point (d)(ii) of the first subparagraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. 2. The participation of the countries referred to in paragraph 1 of this Article in the Media strand and Cross-sectoral strand shall be subject to the fulfilment of the conditions set out in Directive 2010/13/EU. 3. The agreements concluded with countries as referred to in point (c) of paragraph 1 may derogate from the obligations set out in paragraph 2 in duly justified cases. 4. Countries as referred to in points (a) and (b) of paragraph 1 of this Article that fully participated in the 2014-2020 Programme may fully participate in the Programme on a provisional basis if they can show that they have taken tangible steps to align their national law to Directive 2010/13/EU, as amended by Directive (EU) 2018/1808. 5. Countries as referred to in point (b) of paragraph 1 of this Article shall be allowed to continue to participate in the Programme beyond 31 December 2022 provided that they provide the Commission with evidence showing that they have fulfilled the conditions set out in Directive 2010/13/EU. 6. Access to the actions corresponding to the priority referred to in point (d) of Article 7(1) shall be ensured for countries that exceptionally participate in the Culture strand but do not fulfil the conditions for participating in the Media strand and Cross-sectoral strand under paragraph 2 of this Article. Article 10 Other third countries Where it is in the Union\u2019s interest, the Programme may support cooperation with third countries other than those referred to in Article 9 with regard to actions financed through additional financial contributions from the external financing instruments in accordance with Article 8(6). Article 11 Cooperation with international organisations and the European Audiovisual Observatory 1. Access to the Programme shall be open to international organisations that are active in the areas covered by the Programme, in accordance with the Financial Regulation. 2. The Union shall be a member of the Observatory for the duration of the Programme. The Union\u2019s participation in the Observatory shall contribute to the achievement of the priorities of the Media strand. The Commission shall represent the Union in its dealings with the Observatory. The Media strand shall support the payment of the contribution fee for Union membership of the Observatory and data collection and analysis in the audiovisual sector. Article 12 Data gathering on cultural and creative sectors To strengthen the evidence base for the development of the cultural and creative sectors and to measure and analyse their contribution to Europe\u2019s economy and society, the Commission shall gather appropriate data and information, making use of its own expertise and that of the Council of Europe, the OECD, Unesco and relevant research institutions, as appropriate. The Commission shall report regularly to the European Parliament and to the Council on the data gathered. The Commission shall share relevant findings on the data gathered with stakeholders. Article 13 Forms of Union funding and methods of implementation 1. The Programme shall be implemented under direct management in accordance with the Financial Regulation or under indirect management with bodies as referred to in point (c) of Article 62 (1) of that Regulation. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular grants, prizes and procurement. The Programme may also provide financing in the form of financial instruments within blending operations. 3. Blending operations under the Programme shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. 4. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and shall be considered a sufficient guarantee under the Financial Regulation. Article 37 of Regulation (EU) 2021/695 of the European Parliament and of the Council (25) shall apply. 5. Entities active in cultural and creative sectors that have received over 50 % of their annual revenue from public sources over the last two years shall be considered as having the necessary financial, professional and administrative capacity to carry out activities under the Programme. They shall not be required to present further documentation to demonstrate that capacity. Article 14 Protection of the Union\u2019s financial interests Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, that third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 15 Work programmes 1. The Programme shall be implemented through annual work programmes as referred to in Article 110 of the Financial Regulation. Annual work programmes shall give an indication of the amount allocated to each action and set out, where applicable, the overall amount reserved for blending operations. Annual work programmes shall also contain an indicative timetable for implementation. 2. The Commission shall adopt annual work programmes by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24(2). CHAPTER II GRANTS AND ELIGIBLE ENTITIES Article 16 Grants 1. Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation. 2. In order to ensure that applications are properly evaluated, members of evaluation committees may be external experts. External experts shall have a professional background related to the field assessed and, where relevant, knowledge of the geographical area concerned by the application. 3. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, and by way of derogation from Article 193(4) of that Regulation, in duly justified cases specified in the financing decision, activities supported under this Regulation and the underlying costs incurred in 2021 may be considered eligible as of 1 January 2021 even if those activities were implemented and those costs were incurred before the grant application was submitted. The grant agreements for the operating grants of the 2021 financial year may exceptionally be signed within six months of the start of the beneficiary\u2019s financial year. 4. Where applicable, the Programme actions shall set out appropriate criteria to achieve gender equality. Article 17 Eligible entities 1. The eligibility criteria set out in this Article shall apply in addition to the criteria set out in Article 197 of the Financial Regulation. 2. The following entities are eligible to participate in the Programme if they are active in cultural and creative sectors: (a) legal entities established in: (i) a Member State or an overseas country or territory linked to that Member State; (ii) a third country associated to the Programme; or (iii) a third country listed in the work programme, subject to the conditions set out in paragraphs 3 and 4; (b) legal entities created under Union law; (c) international organisations. 3. Legal entities active in the cultural and creative sectors established in a third country which is not associated to the Programme shall exceptionally be eligible to participate in the Programme where such participation is necessary for the achievement of the objectives of a given action. 4. Legal entities active in the cultural and creative sectors established in a third country which is not associated to the Programme shall in principle bear the cost of their participation. Where it is in the Union\u2019s interest, additional contributions from the external financing instruments in accordance with Article 8(6) may cover the costs of the participation of such legal entities. CHAPTER III SYNERGIES AND COMPLEMENTARITY Article 18 Complementarity The Commission, in cooperation with the Member States, shall ensure the overall consistency and complementarity of the Programme with the relevant Union policies and programmes, in particular those relating to gender balance, education, in particular digital education and media literacy, youth and solidarity, employment and social inclusion, in particular for socially marginalised groups and minorities, research, technology and innovation, including social innovation, industry and enterprise, agriculture and rural development, environment and climate action, cohesion, regional and urban policy, sustainable tourism, State aid, mobility and international cooperation and development. Article 19 Cumulative and alternative funding 1. An action that has received a contribution under the Programme may also receive a contribution from any other Union programme, including Funds under the Common Provisions Regulation for 2021-2027, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action, and the support from the different Union programmes may be calculated on a pro-rata basis. 2. A project may be awarded a Seal of Excellence label as defined in point (45) of Article 2 of the Common Provisions Regulation for 2021-2027 under the Programme where it complies with the following cumulative conditions: (a) it has been assessed in a call for proposals under the Programme; (b) it complies with the minimum quality requirements of that call for proposals; and (c) it cannot be financed under that call for proposals due to budgetary constraints. A project that has been awarded a Seal of Excellence label in accordance with the first subparagraph of this paragraph may receive support from the European Regional Development Fund or the European Social Fund Plus in accordance with Article 73(4) of the Common Provisions Regulation for 2021-2027. CHAPTER IV MONITORING, EVALUATION AND CONTROL Article 20 Monitoring and reporting 1. Qualitative and quantitative indicators to report on the progress of the Programme towards the achievement of the objectives laid down in Article 3 are set out in Annex II. 2. To ensure the effective assessment of the Programme\u2019s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 22, to develop the provisions for a monitoring and evaluation framework, including amendments to Annex II in order to review or supplement the indicators where necessary for monitoring and evaluation. 3. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively, and in a timely manner. 4. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where appropriate, on Member States. Article 21 Evaluation 1. The Commission shall carry out evaluations based on the regular collection of data and consultation of stakeholders and beneficiaries, in a timely manner to feed into the decision-making process. 2. Once sufficient information about the implementation of the Programme is available but, in any event, no later than 31 December 2024, the Commission shall carry out an interim evaluation of the Programme, which shall be based, inter alia, on external and independent analyses. The Commission shall submit a report on the interim evaluation to the European Parliament and to the Council no later than six months after the interim evaluation has been carried out. 3. After 31 December 2027 but, in any event, no later than 31 December 2029, the Commission shall carry out a final evaluation of the Programme, which shall be based on external and independent expertise. The Commission shall submit a report on the final evaluation to the European Parliament and to the Council no later than six months after the final evaluation has been carried out. 4. The Commission shall communicate the conclusions of the evaluations referred to in paragraphs 2 and 3, together with its observations on those evaluations, to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions. 5. The evaluation reporting system shall ensure that data for Programme evaluation are collected efficiently, effectively, in a timely manner and at the appropriate level of detail. The recipients of Union funds shall communicate such data and information to the Commission in a way that complies with other legal provisions. For example, personal data shall be made anonymous where necessary. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds. Article 22 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 20 is conferred on the Commission for a period of seven years from 1 January 2021. 3. The delegation of power referred to in Article 20 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 20 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council, or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. CHAPTER V TRANSITIONAL AND FINAL PROVISIONS Article 23 Information, communication and publicity 1. The recipients of Union funds shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public, in particular the name of the Programme and, for actions funded under the Media strand, the Media logo, as set out in Annex III. 2. The Commission shall implement information and communication actions relating to the Programme, to actions taken pursuant to the Programme and to the results obtained. 3. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. Article 24 Committee procedure 1. The Commission shall be assisted by a committee (the \u2018Creative Europe Committee\u2019). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. The Creative Europe Committee may meet in specific configurations to deal with concrete issues relating to the individual strands of the Programme. Article 25 Repeal Regulation (EU) No 1295/2013 is repealed with effect from 1 January 2021. Article 26 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulation (EU) No 1295/2013, which shall continue to apply to those actions until their closure. 2. The financial envelope for the Programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted pursuant to Regulation (EU) No 1295/2013. 3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses for the assistance referred to in Article 8(5), to enable the management of actions not completed by 31 December 2027. Article 27 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 May 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 110, 22.3.2019, p. 87. (2) OJ C 168, 16.5.2019, p. 37. (3) Position of the European Parliament of 28 March 2019 (OJ C 108, 26.3.2021, p. 934) and position of the Council at first reading of 13 April 2021 (OJ C 169, 5.5.2021, p. 1). Position of the European Parliament of 18 May 2021 (not yet published in the Official Journal). (4) Decision No 445/2014/EU of the European Parliament and of the Council of 16 April 2014 establishing a Union action for the European Capitals of Culture for the years 2020 to 2033 and repealing Decision No 1622/2006/EC (OJ L 132, 3.5.2014, p. 1). (5) Directive (EU) 2019/789 of the European Parliament and of the Council of 17 April 2019 laying down rules on the exercise of copyright and related rights applicable to certain online transmissions of broadcasting organisations and retransmissions of television and radio programmes, and amending Council Directive 93/83/EEC (OJ L 130, 17.5.2019, p. 82). (6) Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92). (7) Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, p. 1). (8) Directive (EU) 2018/1808 of the European Parliament and of the Council of 14 November 2018 amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) in view of changing market realities (OJ L 303, 28.11.2018, p. 69). (9) Decision No 1194/2011/EU of the European Parliament and of the Council of 16 November 2011 establishing a European Union action for the European Heritage Label (OJ L 303, 22.11.2011, p. 1). (10) OJ C 334, 19.9.2018, p. 253. (11) OJ L 1, 3.1.1994, p. 3. (12) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (13) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (14) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (15) OJ L 433 I, 22.12.2020, p. 28. (16) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (17) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p.1). (18) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (19) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor's Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (20) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (21) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (Overseas Association Decision) (OJ L 344, 19.12.2013, p. 1). (22) OJ L 123, 12.5.2016, p. 1. (23) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (24) Regulation (EU) No 1295/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Creative Europe Programme (2014 to 2020) and repealing Decisions No 1718/2006/EC, No 1855/2006/EC and No 1041/2009/EC (OJ L 347, 20.12.2013, p. 221). (25) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). ANNEX I DESCRIPTION OF THE PROGRAMME ACTIONS SECTION 1 CULTURE STRAND The priorities of the Culture strand referred to in Article 5 shall be pursued, including with the aim of strengthening the circulation of European works in a digital and multilingual environment, and where appropriate, by means of translation, regardless of the type of medium used, through the following actions, the details of which, including possible higher co-financing rates for small-scale projects, shall be defined in the work programmes: Horizontal actions: Horizontal actions aim to support all the cultural and creative sectors, with the exception of the audiovisual sector, in addressing common challenges they face at European level. In particular, horizontal actions shall co-finance transnational projects for collaboration, networking, mobility and internationalisation, including through residency programmes, touring, events, exhibitions and festivals. The following horizontal actions shall be supported under the Programme: (a) transnational cooperation projects that bring together organisations in the cultural and creative sectors of all sizes, including micro-organisations and small-sized organisations, and from different countries to undertake sectoral or cross-sectoral activities; (b) European networks of organisations in the cultural and creative sectors from different countries; (c) cultural and creative pan-European platforms; (d) transnational mobility of artists and operators in the cultural and creative sectors and the transnational circulation of artistic and cultural works; (e) support, including in terms of capacity building, to organisations in the cultural and creative sectors in order to help them operate at the international level; (f) policy development, cooperation and implementation in the field of culture, including through the provision of data and the exchange of best practices, pilot projects and incentives to promote gender equality. Sectoral actions: To respond to shared needs within the Union, the following sectoral actions shall be supported in those cultural and creative sectors, notably the music sector, whose specificities or specific challenges require a more targeted approach that complements the horizontal actions: (a) support to the music sector: actions that promote diversity, creativity and innovation in the field of music, including live performance, in particular, the distribution and promotion of all musical repertoires in Europe and beyond, training actions, participation in and access to music, and audience development for all European repertoires, and support for data gathering and analysis; those actions shall build on and continue to support the experiences and expertise gained within the \u2018Music moves Europe\u2019 initiative; (b) support to the book and publishing sector: targeted actions that promote diversity, creativity and innovation, the promotion of European literature across borders in Europe and beyond, including in libraries, training and exchanges for sector professionals, authors and translators and transnational projects for collaboration, innovation and development in that sector; targeted actions that promote the translation of literature and, where possible, the adaptation of literature into accessible formats for people with disabilities; (c) support to architecture and cultural heritage for a quality built environment: targeted actions for the mobility, capacity-building and internationalisation of architecture and cultural heritage operators; the promotion of Baukultur, peer learning and audience engagement in order to disseminate high-quality principles in contemporary architecture and cultural heritage interventions; support to the sustainable safeguarding, the regeneration and the adaptive reuse of cultural heritage and the promotion of its values through awareness-raising and networking activities; (d) support to other sectors of artistic creation where specific needs are identified, including targeted actions for the development of the creative aspects of sustainable cultural tourism and of the design and fashion sectors and for the promotion and representation of those other sectors of artistic creation outside the Union. Special actions that aim to render European cultural diversity and heritage visible and tangible and to nurture intercultural dialogue: (a) financial support to the European Capitals of Culture; (b) financial support to the European Heritage Label and networking activities between the sites awarded the European Heritage Label; (c) Union cultural prizes; (d) European Heritage Days; (e) support to European cultural entities such as orchestras that aim to train and promote young, high-potential artists and have an inclusive approach with a large geographical coverage, or entities that deliver direct cultural services to European citizens with a large geographical coverage. SECTION 2 MEDIA STRAND The priorities of the Media strand referred to in Article 6 shall take into account the requirements of Directive (EU) 2018/1808 and the differences across countries regarding the production and distribution of, and access to, audiovisual content and the size and specificities of their respective markets and linguistic diversity, and shall be pursued through the following actions, the details of which shall be defined in the work programmes: (a) the development of audiovisual works by European independent production companies, covering a variety of formats (such as feature films, short films, series, documentaries and narrative video games) and genres, and targeting diverse audiences, including children and young people; (b) the production of innovative and quality TV content and serial storytelling, addressing diverse audiences, by European independent production companies; (c) promotion and marketing tools, including online and through the use of data analytics, to increase the prominence, visibility, cross-border access, and audience reach of European works; (d) support to international sales and circulation of non-national European works on all platforms (e.g. cinema theatres, online) targeting both small and large-sized productions, including through coordinated distribution strategies covering several countries and encouraging the use of subtitling, dubbing and, where applicable, audio description tools; (e) support to the multilingual access to cultural TV programmes online through subtitling; (f) support to networking activities for audiovisual professionals, including creators, and business-to-business exchanges to nurture and promote talent in the European audiovisual sector, and facilitate the development and distribution of European and international co-creations and co-productions; (g) support to activities of European audiovisual operators at industry events and fairs in Europe and beyond; (h) support to the visibility and outreach of European films and audiovisual creations aimed at wide European audiences beyond national borders, especially young people and multipliers, including through the organisation of screenings, communication, dissemination and promotion activities in support of European Awards, in particular \u2018LUX - the European Audience Film Award by the European Parliament and the European Film Academy\u2019; (i) initiatives promoting audience development and engagement, including film education activities, addressing in particular young audiences; (j) training and mentoring activities to enhance the capacity of audiovisual professionals to adapt to new creative processes, market developments and digital technologies that affect the whole value chain; (k) a network or networks of European Video on Demand operators, screening a significant proportion of non-national European works; (l) European festivals and a European festivals\u2019 network or European festivals\u2019 networks screening a significant proportion of non-national European works, while preserving their identity and unique profile; (m) a European cinema operators\u2019 network, with a broad geographic coverage, screening a significant proportion of non-national European films, fostering the role of European cinemas in the circulation of European works; (n) specific measures to contribute to a more balanced gender participation in the audiovisual sector, including studies, mentoring, training and networking activities; (o) support to policy dialogue, innovative policy actions and exchange of best practices \u2013 including through analytical activities and the provision of reliable data; (p) transnational exchange of experiences and know-how, peer learning activities and networking among the audiovisual sector and policy makers. SECTION 3 CROSS-SECTORAL STRAND The priorities of the Cross-sectoral strand referred to in Article 7 shall be pursued through the following actions, the details of which shall be defined in the work programmes: Policy cooperation and outreach actions that: (a) support policy development, the transnational exchange of experiences and know-how, peer learning and awareness raising activities, networking, and regular cross-sectoral dialogue among organisations in the cultural and creative sectors and policy makers; (b) support analytical cross-sectoral activities; (c) aim to foster cross-border policy cooperation and policy development with regard to the role of social inclusion through culture; (d) enhance knowledge of the Programme and the topics it covers, foster citizen outreach and assist with the transferability of results beyond Member State level. The \u2018creative innovation lab\u2019 actions, which shall: (a) encourage new forms of creation at the crossroads between different cultural and creative sectors, for example through experimental approaches and the use of innovative technologies; (b) foster innovative cross-sectoral approaches and tools which shall, where possible, encompass multilingual and social dimensions to facilitate the distribution, promotion and monetisation of, and access to, culture and creativity, including cultural heritage. The \u2018Programme desks\u2019 actions, which shall: (a) promote the Programme at national level, provide relevant information on the various types of financial support available under Union policy, and assist operators in the cultural and creative sectors to apply for support under the Programme, including by informing them of the requirements and procedures related to the various calls for proposals and by sharing good practices; (b) support potential beneficiaries in application processes and provide peer mentoring for newcomers to the Programme, stimulate cross-border cooperation and the exchange of best practices between professionals, institutions, platforms and networks within and across the policy areas covered by the Programme and cultural and creative sectors; (c) support the Commission in ensuring proper communication and dissemination of the results of the Programme to citizens and operators in the cultural and creative sectors. Cross-cutting actions that support the news media sector, which shall: (a) address the structural and technological changes faced by the media sector by promoting an independent and pluralistic media environment, including by supporting independent monitoring for assessing risks and challenges to media pluralism and freedom, and by supporting awareness-raising activities; (b) support high-quality media production standards by fostering cooperation, digital skills, cross-border collaborative journalism, and quality content, thereby contributing to professional ethics in journalism; (c) promote media literacy in order to enable citizens to use, and develop a critical understanding of, the media and support knowledge sharing and exchanges on media literacy policies and practices; (d) include specific measures to contribute to a more balanced gender participation in the news media sector. ANNEX II COMMON QUALITATIVE AND QUANTITATIVE IMPACT PROGRAMME INDICATORS The number and scale of transnational partnerships created with the support of the Programme, including the country of origin of the beneficiary organisations. Qualitative evidence of success stories in the artistic, business and technological innovation fields due to Programme support. Indicators Culture strand: The number and scale of transnational partnerships created with the support of the Programme. The number of artists and operators in the cultural and creative sectors that have moved beyond national borders due to Programme support, indicating the country of origin and the proportion of women. The number of people who have accessed European cultural and creative works supported by the Programme, including works from countries other than their own. The number of projects supported by the Programme addressed to socially marginalised groups. The number of projects supported by the Programme involving organisations from third countries. Media strand: The number of people who have accessed European audiovisual works supported by the Programme from countries other than their own. The number of participants in learning activities supported by the Programme who have assessed that they have improved their competences and increased their employability, indicating the proportion of women. The number, budget and geographical origins of co-productions developed, created and distributed with the support of the Programme and co-productions with partners from countries with different audiovisual capacities. The number of audiovisual works in lesser-used languages developed, produced and distributed with the support of the Programme. The number of people reached by Business to Business promotional activities in major markets. Cross-sectoral strand: The number and scale of transnational partnerships formed (composite indicator for the \u2018creative innovation lab\u2019 action and cross-cutting actions that support the news media sector). The number of events or activities promoting the Programme organised by the Programme desks. The number of participants in the \u2018creative innovation lab\u2019 action and cross-cutting actions that support the news media sector, indicating the proportion of women. ANNEX III MEDIA STRAND LOGO The Media strand logo shall be as follows:", "summary": "Creative Europe Creative Europe SUMMARY OF: Regulation (EU) 2021/818 establishing the creative Europe programme (2021 to 2027) WHAT IS THE AIM OF THE REGULATION? The creative Europe programme aims to: safeguard, develop and promote European cultural and linguistic diversity and heritage; increase the competitiveness and the economic potential of the cultural and creative sectors, in particular the audiovisual sector. KEY POINTS The programme has three specific objectives: to enhance artistic and cultural cooperation at the European Union (EU) level in order to support the creation of European works and strengthen the economic, social and external dimensions of \u2014 and innovation and mobility in \u2014 Europe\u2019s cultural and creative sectors; to promote competitiveness, scalability, cooperation, innovation and sustainability, including through mobility, in the European audiovisual sector; to promote policy cooperation and innovative actions supporting all strands of the programme and to promote a diverse, independent and pluralistic media environment, along with media literacy, thereby fostering freedom of artistic expression, intercultural dialogue and social inclusion. Action strands The programme consists of three distinct strands, each with defined priorities: a culture strand covering the cultural and creative sectors, with the exception of the audiovisual sector \u2014 its priorities include the strengthening of the transnational cooperation and the cross-border dimension of creation, circulation and visibility of European works; a media strand covering the audiovisual sector \u2014 its priorities include stimulating cross-border cooperation, mobility and innovation in the creation and production of European audiovisual works; a cross-sectoral strand covering actions across all cultural and creative sectors \u2014 its priorities include supporting cross-sectoral transnational policy cooperation on promoting the role of culture for social inclusion and on artistic freedom, along with quality journalism and media literacy. Budget The programme lasts from 1 January 2021 to 31 December 2027, i.e. the duration of the multiannual financial framework. It has a budget of \u20ac1.842 billion at current prices, with a further \u20ac600 million at 2018 prices. At least 33% of this amount is allocated to culture, at least 58% to media and up to 9% to cross-sectoral actions. The regulation includes the forms of EU funding available and the rules for granting such funding. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND Creative Europe (European Commission). MAIN DOCUMENT Regulation (EU) 2021/818 of the European Parliament and of the Council of 20 May 2021 establishing the Creative Europe Programme (2021 to 2027) and repealing Regulation (EU) No 1295/2013 (OJ L 189, 28.5.2021, pp. 34-60) RELATED DOCUMENTS Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222) last update 19.07.2021"}
{"article": "28.5.2021 EN Official Journal of the European Union L 189/91 DECISION (EU) 2021/820 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 May 2021 on the Strategic Innovation Agenda of the European Institute of Innovation and Technology (EIT) 2021-2027: Boosting the Innovation Talent and Capacity of Europe and repealing Decision No 1312/2013/EU (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 173(3) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Regulation (EU) 2021/819 of the European Parliament and of the Council (3), and in particular Article 4 thereof, provides for the adoption of a Strategic Innovation Agenda (SIA). (2) The SIA should set out the priority fields and the strategy for the European Institute of Innovation and Technology (EIT) for the seven-year period concerned in accordance with Regulation (EU) 2021/695 of the European Parliament and of the Council (4), should establish the EIT\u2019s key actions and should include an assessment of the EIT\u2019s expected social, economic and environmental impact, its outreach activities and its capacity to generate best innovation added-value. The SIA should take into account the results of the continuous monitoring and periodic independent evaluation of the EIT. (3) The SIA should also take into account the strategic planning of Horizon Europe \u2013 the Framework Programme for Research and Innovation (Horizon Europe), established by Regulation (EU) 2021/695, establish and foster appropriate synergies and complementarities between EIT activities and other relevant Union, national and regional initiatives, instruments and programmes, and ensure consistency with Union priorities and commitments, including those referred to in the communications of the Commission of 11 December 2019 on the European Green Deal, of 27 May 2020 on EU budget powering the recovery plan for Europe (Recovery Plan for Europe), of 19 February 2020 on a European strategy for data, of 10 March 2020 on an SME Strategy for a sustainable and digital Europe and of 10 March 2020 on a New Industrial Strategy for Europe and those related to achieving Europe\u2019s strategic autonomy, while retaining an open economy. (4) The SIA should include an estimate of financial needs and sources for the future activities of the EIT. It should also include an indicative financial plan covering the period of the relevant multiannual financial framework (MFF). (5) In order to ensure the continuity of the activities of the EIT and the Knowledge and Innovation Communities (KICs) in compliance with the relevant provisions of Regulation (EU) 2021/695, this Decision should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021. (6) Since the objectives of this Decision cannot be sufficiently achieved by the Member States but can rather, by reason of scale and transnationality, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives. (7) Decision No 1312/2013/EU of the European Parliament and of the Council (5) should be repealed, HAVE ADOPTED THIS DECISION: Article 1 The Strategic Innovation Agenda of the European Institute of Innovation and Technology for the period from 2021 to 2027 (SIA 2021-2027) as set out in the Annex is hereby adopted. Article 2 SIA 2021-2027 shall be implemented in accordance with Regulation (EU) 2021/819. Article 3 Decision No 1312/2013/EU is repealed with effect from 1 January 2021. Article 4 This Decision shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. Done at Brussels, 20 May 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 47, 11.2.2020, p. 69. (2) Position of the European Parliament of 27 April 2021 (not yet published in the Official Journal) and decision of the Council of 10 May 2021. (3) Regulation (EU) 2021/819 of the European Parliament and of the Council of 20 May 2021 on the European Institute of Innovation and Technology (see page 61 of this Official Journal). (4) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2013 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1)). (5) Decision No 1312/2013/EU of the European Parliament and of the Council of 11 December 2013 on the Strategic Innovation Agenda of the European Institute of Innovation and Technology (EIT): the contribution of the EIT to a more innovative Europe (OJ L 347, 20.12.2013, p. 892). ANNEX THE STRATEGIC INNOVATION AGENDA OF THE EUROPEAN INSTITUTE OF INNOVATION AND TECHNOLOGY FOR THE PERIOD FROM 2021 TO 2027 Table of contents 1. Introduction 94 1.1. Background 94 1.2. Key challenges 95 1.3. Positioning in Horizon Europe 97 2. Raising the bar: EIT strategy and objectives for 2021-2027 98 3. Boosting the Innovation Talent and Capacity of Europe: Key actions 98 3.1. Support for existing KICs 98 3.2. Increasing the regional impact of KICs 99 3.3. Launch of new KICs 100 3.4. Supporting the innovation and entrepreneurial capacity of higher education institutions 101 3.5. EIT cross-cutting activities 102 3.5.1. Communication and dissemination 102 3.5.2. Identify and share good practices with stakeholders 103 3.5.3. International cooperation and global outreach activities 103 3.6. Making it work: mode of operation 104 3.6.1. KIC operational model 104 3.6.2. KIC funding model 105 3.6.3. Reducing the administrative burden 106 3.6.4. EIT relation with KICs after the termination of the partnership agreement 106 3.7. Synergies and complementarities with other Union programmes 106 4. Tackling the crisis resulting from the outbreak of COVID-19 108 5. Resources 108 5.1. Budget needs 108 5.2. Impact (monitoring and evaluation) 109 5.2.1. Reporting and monitoring 109 5.2.2. Evaluation, interim review and comprehensive assessment 111 Appendix 1 112 Appendix 2 115 1. INTRODUCTION This Strategic Innovation Agenda sets out the priority fields and strategy of the European Institute of Innovation and Technology (EIT) for 2021-2027 (SIA 2021-2027). It establishes the EIT\u2019s objectives, key actions, mode of operation, expected results and impact, as well as an estimate of the resources needed. SIA 2021-2027 ensures the necessary consistency of the EIT with Horizon Europe. SIA 2021-2027 is informed by an impact assessment carried out by the Commission. It takes into account the draft SIA prepared by the EIT and submitted to the Commission on 20 December 2017, in accordance with Regulation (EC) No 294/2008 of the European Parliament and of the Council (1). It also reflects Regulation (EU) 2021/695, and, in particular, the key role of the EIT as part of Pillar III \u2018Innovative Europe\u2019 of Horizon Europe, and its contribution to addressing global and societal challenges, including established targets and commitments to climate objectives and the United Nations (UN) Sustainable Development Goals (SDGs), and to Pillar I \u2018Excellent Science\u2019 and Pillar II \u2018Global Challenges and European Industrial Competitiveness\u2019 of Horizon Europe. SIA 2021-2027 builds on the lessons learnt over the previous years of operation of the EIT and the results of a wide consultation process with key stakeholders. SIA 2021-2027 takes into account the strategic planning of Horizon Europe to ensure consistency with the Horizon Europe activities, as well as synergies with other relevant Union programmes and consistency with Union priorities and commitments, including those related to the European Green Deal, the Recovery Plan for Europe, the European strategy for data, the SME Strategy for a sustainable and digital Europe and the New Industrial Strategy for Europe and those related to achieving the Union\u2019s strategic autonomy, while retaining an open economy. Furthermore, it contributes to tackling global and societal challenges, including the SDGs by following the principles of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (2), and to achieving a net-zero greenhouse gas economy by 2050 at the latest. It also aims to increase complementarity and synergies between the EIT activities and national and regional funding programmes and priorities. 1.1. Background The EIT was established in 2008 in order to contribute to sustainable economic growth and competitiveness by reinforcing the innovation capacity of the Union and Member States. It pioneered the integration of higher education, research and innovation (the \u2018knowledge triangle') together with a strong emphasis on entrepreneurial talent, business creation and innovation skills. Since its establishment, the EIT has gradually established itself as a unique instrument addressing societal challenges through the integration of the knowledge triangle. The EIT operates mainly through Knowledge and Innovation Communities (KICs) (3). There are currently eight KICs that operate in the areas of climate change, digital transformation, energy, food, health, raw materials, urban mobility and added-value manufacturing. Each KIC has to date been organised around five to ten co-location centres (CLCs) (4), which are intended to act as geographical hubs that also provide a physical space for local interaction within the innovation ecosystem and for the practical integration of the knowledge triangle. CLCs are organised and structured according to their relevant national and regional innovation context and build on a pan-European network of existing labs, offices or campuses of a KIC partner. The KICs aim to run portfolios of knowledge triangle activities through: (a) education and training activities with strong entrepreneurship components to train the next generation of talents, including the design and implementation of programmes, in particular at master\u2019s and doctoral level, awarded the EIT label, namely a quality seal awarded by the EIT to a KIC\u2019s educational programme which complies with specific quality criteria related, inter alia, to entrepreneurial education and innovative \u2018learning-by-doing\u2019 curricula, the EIT\u2019s education agenda being key to developing highly entrepreneurial and skilled innovators, hence the importance of programmes and activities aiming to develop entrepreneurship and digital skills and re-skill and up-skill human resources in a lifelong learning perspective; (b) activities that support research and innovation to develop innovative and sustainable products, processes, technologies, services and non-technological solutions that address a specific business opportunity or social objective; (c) business creation and support activities, such as accelerator schemes to help entrepreneurs translate their ideas into successful ventures and speed up the growth and development process. The focus on global and societal challenges through the integration of the knowledge triangle, integrating higher education activities in the innovation value chain, is a distinctive feature of the EIT compared to other innovation instruments. The EIT approach helps to build resilience and increase sustainability and contributes to the creation of incremental and disruptive innovations, in order to effectively address market failures and help transform industries and support the creation of start-ups, spin-offs and small and medium-sized enterprises (SMEs). The EIT enables the creation of long-term business strategies for addressing global challenges and helps create the framework conditions that are essential for a well-functioning innovation ecosystem to grow and for innovation to thrive. Regulation (EU) 2021/819 provides for the objective that the KICs become financially sustainable (5), which is a unique feature, aiming to create a business and results-oriented innovation. In that context, the KICs are to develop and implement revenue-creating strategies in order to maintain their innovation ecosystem and knowledge triangle activities beyond the period covered by the grant agreements. The EIT thus offers a dynamic platform for launching, scaling up, monitoring and supporting KICs with strong network effects and positive spill-overs. The KICs in the first wave (EIT Digital, EIT Climate-KIC and EIT InnoEnergy), launched in 2009, are established and mature and their partnership agreements are to be terminated after 2024, in line with the maximum grant duration. A second and third generation of KICs (EIT Health and EIT Raw Materials, launched in 2014, and EIT Food, launched in 2016) are maturing. The KICs EIT Urban Mobility and EIT Manufacturing were both launched in December 2018 and started their operations in 2019. By 2019, there were more than 600 businesses, 250 higher education institutions (HEIs) (6), 200 research organisations (7), and more than 50 civil society organisations and authorities participating in the eight KICs. Against the backdrop of persisting regional disparities in innovation performance in Europe, the EIT launched a regional innovation scheme (RIS) (8) in 2014 to widen its regional outreach to modest and moderate innovator countries. Through the RIS, the EIT has expanded its activities across Europe and offers opportunities for countries (and regions in those countries) with modest and moderate innovation performance as classified in the European Innovation Scoreboard (EIS) to engage in knowledge triangle activities as part of a KIC community. The EIT has been able to stay agile and to develop the governance principles and rules for the successful management of the KICs under the overall umbrella of Horizon 2020 established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council (9), in accordance with Regulation (EC) No 294/2008. Its operational independence has allowed it to test and effectively implement a number of novelties in the management of its beneficiaries, such as a competitive funding mechanism, financial sustainability targets and specific key performance indicators. 1.2. Key challenges In recent years, the pace of innovation has accelerated dramatically. Innovation is reshaping economic sectors, disrupting existing businesses and creating unprecedented opportunities. With a shifting global economic order and international competition on the rise, the Union needs, inter alia, to involve all talents, increase the participation of women and foster a swift transfer of the results of research and innovation activities to the market and society, with the aim of increasing innovation capacity across the Union. Co-design, collaboration and co-creation across disciplines and between higher education, research and business have never been so important in contributing to address global challenges related to climate change, biodiversity loss and unsustainable use of natural resources, digital and social transformation, demographic shifts and the future of healthcare and food. First, the spread of COVID-19 has had a major impact on our economies and societies, disrupting economic activities, affecting healthcare systems, jobs and well-being. In order to address the crisis, a combination of short-term and forward-looking measures are required in order to provide immediate support to the economies and stakeholders, while ensuring the necessary conditions for the recovery to take place. It is therefore important to identify and tackle crisis-related challenges, including access to finance, in order to rebuild trust and confidence among all stakeholders as well as support the development and implementation of solutions to ease the impact of crises on society. At the same time, programmes supporting innovation, business creation and upgrade, entrepreneurial and innovation skills are key to putting the Union economy on the right track and propelling a swift recovery. Stronger innovation ecosystems have proved to respond more quickly and resolutely to crises. In order to accelerate the recovery and be able to tackle future emergencies, investments in improving coordination capacities within innovation ecosystems are essential to increase their resilience and their responsiveness to deliver promptly the needed solutions. In the medium and long term, all the KICs need to adapt to the impacts of the shock and ensure agility and flexibility in order to find and pursue new opportunities. Thanks to their \u2018place-based\u2019 approach through CLCs and RIS hubs (10) across Europe, the KICs contribute to strengthening local innovation ecosystems, inter alia, by fostering closer interactions between the actors of the knowledge triangle and by favouring better coordinated relations with financial and public institutions, as well as with citizens. Second, today\u2019s societies and economies are increasingly driven by the skills and abilities of people and organisations to turn ideas into novel products, processes, services, businesses and societal models. Innovation, entrepreneurial culture, market uptake of innovative solutions and increased investments in education, research and innovation will make all the difference if the Union is to succeed in its transition towards a competitive, digital, climate-neutral and inclusive society. There is a strong need to further boost collaboration between disciplines and interdisciplinary learning, as well as the innovation capacity of HEIs across the Union. The EIT is in a unique position to fulfil that need in the Horizon Europe framework. Third, physical proximity is one of the key factors enabling innovation. Initiatives aiming to develop innovation networks and providing services that support the creation, sharing and transfer of knowledge play a key role in fostering interactions between academia, research organisations, business, public authorities and individuals. Still, research and innovation performances across the Union, as reflected in the annual EIS, vary considerably. It is of crucial importance that innovation is inclusive and rooted in local territories with a particular attention to the increased involvement of SMEs and third sector organisations. EIT activities are well suited to contribute to strengthening local innovation ecosystems with a strong European dimension and provide new models for a sustainable economy. The activities of the EIT and the KICs have yet to become increasingly linked to regional strategies and smart specialisation strategies (11). Fourth, vibrant innovation ecosystems require a mix of knowledge, investment, infrastructure and talent. Framework conditions for cooperation between European research, education and innovation along with strong synergies need to be in place in order to ensure proper and efficient investment of scarce resources and to leverage other sources of funding aiming to achieve financial sustainability. Strengthening the knowledge triangle integration through KICs, including through the involvement of new partners in other sectors, countries and regions, is a proven way to foster an environment conducive to innovation and is a guiding objective of the EIT. 1.3. Positioning in Horizon Europe In the context of Regulation (EU) 2021/695, the Commission made a firm commitment to raise Europe\u2019s innovation potential further in order to be able to respond to future challenges. The EIT\u2019s distinctive role in fostering innovation by bringing together business, education, research, public authorities and civil society is reinforced by its positioning in Pillar III \u2018Innovative Europe\u2019 of Horizon Europe. Regulation (EU) 2021/695 reflects the growing Union ambition of innovation and the need to deliver on that ambition. The strategic planning of Horizon Europe aims to ensure coherence between the EIT activities and other activities under Regulation (EU) 2021/695. The EIT shall contribute to the strategic coordinating process for European Partnerships. The EIT shall continue to work closely with other implementing bodies under the Pillar III \u2018Innovative Europe\u2019 of Horizon Europe and use best efforts to contribute to a one-stop shop for innovation. The EIT shall continue to strengthen innovation ecosystems that help to tackle global challenges by fostering the integration of the knowledge triangle in the thematic areas of activity of the KICs. Strong synergies, including through cooperation at governance level, between the implementing bodies of the Pillar III \u2018Innovative Europe\u2019 of Horizon Europe are required. The EIT and the European Innovation Council (EIC) shall run complementary activities aiming to streamline the support provided to innovative businesses, including business acceleration services and training. The EIC may help start-ups supported by KICs with a high growth potential to rapidly scale-up. In particular, the most innovative ventures supported by the KICs may benefit from simplified and thereby faster access to EIC actions, in particular to the support offered by the EIC Accelerator and by the financial support offered by the InvestEU Programme established by Regulation (EU) 2021/523 of the European Parliament and of the Council (12). Furthermore, the EIT shall facilitate the access of EIC beneficiaries to the KICs\u2019 innovation ecosystems and relevant actors of the knowledge triangle. EIC beneficiaries can thus become actively involved in the KICs\u2019 activities and benefit from the KICs\u2019 services. The EIT shall ensure consistency with the European innovation ecosystems component of Pillar III \u2018Innovative Europe\u2019 of Horizon Europe. In particular, the EIT shall take an active part in the activities of the EIC Forum referred to in Council Decision (EU) 2021/764 (13) and shall establish links between the EIT Community (14) and relevant activities supporting innovation ecosystems in order to avoid duplication and to ensure the consistency and complementarity between actions of the EIT and of the EIC. The EIT shall also ensure stronger synergies between its actions and the programmes and initiatives of the Pillar I \u2018Excellent Science\u2019 of Horizon Europe, to accelerate the transfer of knowledge resulting from blue sky research into concrete applications benefiting society. In particular, with regard to the Marie Sk\u0142odowska-Curie Actions (MSCA) and the European Research Council (ERC), the EIT shall collaborate on the development of innovation and entrepreneurial skills of MSCA fellows and ERC grantees at all stages of their career. That collaboration shall remain voluntary and shall not increase the administrative burden on the beneficiaries. The EIT shall contribute to the Pillar II \u2018Global Challenges and European Industrial Competitiveness\u2019 of Horizon Europe, complement relevant activities to tackle global and societal challenges, and foster the sustainable growth and competitiveness of the Union on a global scale. In particular, through the KICs, the EIT shall seek to contribute to and ensure stronger synergies with relevant missions and thematic clusters and other European Partnerships, such as by supporting demand-side measures and providing exploitation services to boost technology transfer and accelerate the commercialisation of results achieved. The EIT shall explore opportunities for synergies between the \u2018Widening Participation and Strengthening the European Research Area\u2019 part of Horizon Europe, including the teaming and twinning activities and the outreach activities that it supports. In particular, target entities of the \u2018Widening Participation and Strengthening the European Research Area\u2019 part of Horizon Europe, as well as EIT outreach activities, may leverage EIT expertise and support. 2. RAISING THE BAR: EIT STRATEGY AND OBJECTIVES FOR 2021-2027 During the period 2021-2027, the EIT shall continue to support the KICs in order to strengthen the innovation ecosystems that help to tackle global and societal challenges, in full complementarity with Horizon Europe and other Union programmes. It shall do so by fostering the integration of higher education, research and innovation, thereby creating environments conducive to innovation, and by promoting and supporting a new generation of entrepreneurs, contributing also to closing the entrepreneurial gender gap and to stimulating the creation of innovative businesses, with a particular focus on SMEs, in close synergy and complementarity with the EIC. Particular attention shall also be paid to gender balance and gender-sensitive approaches, in particular in areas where women remain underrepresented, such as information and communications technologies, science, technology, engineering and mathematics. In doing so, on the basis of the areas of intervention established in Regulation (EU) 2021/695, the EIT shall, in particular: (1) strengthen sustainable innovation ecosystems across Europe; (2) foster innovation and entrepreneurial skills in a lifelong learning perspective, including increasing capacities of HEIs across Europe; (3) create new solutions to the market to address global challenges; and (4) ensure synergies and value added within Horizon Europe. In line with the challenges that the EIT is facing and in order to contribute to its general objectives as set out in Article 3 of Regulation (EU) 2021/819 and thereby to the scientific, economic, technological and societal impact of Horizon Europe, the EIT\u2019s specific objectives for 2021-2027 shall be to: (a) increase the openness, impact and transparency of the KICs and the integration of the knowledge triangle across the Union; (b) increase the entrepreneurial and innovation capacity of higher education across Europe by promoting and supporting institutional change in HEIs and the integration of HEIs in innovation ecosystems; (c) increase the regional and local outreach of the EIT and the KICs, in particular by including a wider range of stakeholders in order to address disparities in innovation capacity and to enhance knowledge and innovation diffusion across the Union. The EIT may, where relevant, respond to the COVID-19 crisis and potential future crises with the necessary flexibility by integrating relevant initiatives in its strategy in order to contribute to protecting the innovation ecosystems and to help EIT stakeholders prepare for the economic recovery. 3. BOOSTING THE INNOVATION TALENT AND CAPACITY OF EUROPE: KEY ACTIONS The EIT strategy for 2021-2027 shall focus on actions adding value at Union level and contributing to achieving the objectives of Horizon Europe. First, the EIT shall continue to support the innovation capacity and ecosystems across the Union through the KICs, their further development, openness to new partners, enhanced transparency, compliance with good governance principles and expansion. Second, building on its experience with the knowledge triangle integration, the EIT shall steer the support and development of entrepreneurial and innovation capacity of HEIs, which will be implemented through the KICs. Third, through more effective cross-cutting measures, the EIT shall make all necessary efforts to ensure that its visibility and impact at Union level increase. In addition, the EIT shall improve its operations in order to increase its effectiveness, efficiency and impact, including in areas such as guiding the KICs towards financial sustainability, the openness, outreach, transparency, quality and sustainability of its own activities and the activities of the KICs, a higher involvement of SMEs and start-ups, and gender balance. 3.1. Support for existing KICs The EIT shall strengthen innovation ecosystems by continuing to support existing KICs in addressing global challenges through the integration of the knowledge triangle at Union, national, regional and local level. To that end, a large share of the EIT budget is to be dedicated to support the KICs, and the EIT shall further strengthen its platform for launching, growing and monitoring the KICs. The EIT shall ensure that the KICs continue to pursue financial sustainability, in order to achieve financial independence from the EIT grant at the latest after 15 years following their launch by leveraging public and private investment, while still focusing on the integration of knowledge triangle activities. The EIT shall ensure that the KICs develop and implement a strategy to collaborate and create interfaces and synergies with relevant European Partnerships, missions and the EIC, as well as with other relevant Union and international initiatives and programmes. In addition to financial support, based on lessons learned, the EIT shall provide strategic supervision and guidance to the KICs. On the basis of the indicators listed, inter alia, in Annex V to Regulation (EU) 2021/695, the EIT shall monitor and analyse the performance, the leverage investments and the different qualitative and quantitative impacts. The EIT shall make best efforts to streamline the terminology related to the structure of each KIC, with the purpose of further simplifying and enhancing the recognisability of the EIT. The EIT shall establish areas of, and promote stronger cross-KIC collaboration on, topics of strategic and policy relevance. The EIT shall strengthen coordination between KICs in areas of common interest, in particular by fostering exchanges of experiences and good practices between KICs and collaboration between them (cross-KIC activities (15)) on both thematic and horizontal topics. Cross-KIC activities have the highest potential where several KICs already address common Union policy priorities where no dedicated KICs exist. Bringing together the different KICs communities in dedicated joint actions of mutual benefit has high potential for synergies and interdisciplinary benefits. The EIT shall encourage such activities and take an active part in defining the content and structure of the cross-KIC activities. It shall monitor the implementation of cross-KIC activities as well as the results achieved, with the aim of making those activities an integral part of the KICs\u2019 multiannual strategies. The EIT shall also facilitate the establishment of cross-KIC shared services with the purpose of jointly handling operational tasks common for all the KICs. 3.2. Increasing the regional impact of KICs The EIT shall further increase its regional impact through an enhanced openness and inclusive approach of the KICs towards a wide range of potential partners and stakeholders, a strengthened dissemination and exploitation of results and a better integrated regional strategy of KICs. Each KIC will be required to develop and implement a regional strategy as an integral part of its business plans with the aim of strengthening the relationship with national, regional and local innovation actors, including SMEs. Where relevant, the KICs shall demonstrate links with smart specialisation strategies and with the activities of thematic platforms and interregional initiatives, including with the managing authorities of European structural and investment funds (ESIF). The EIT shall continuously monitor the implementation of those strategies, including the leverage effect on the ESIF. A so-called \u2018place-based\u2019 innovation approach is to be integrated within the KICs\u2019 multiannual strategy and business plan and build on its CLCs and RIS hubs, thus leveraging their role as a gateway for accessing a KIC community, and interacting with the co-located partners, as well as with other local innovation actors. The EIT shall monitor how CLCs and RIS hubs operate and how they integrate in the local innovation ecosystems. The EIT shall ensure that RIS activities are used to attract and facilitate integration of potential new partners that add value to the KICs, thus extending the EIT\u2019s pan-European coverage, and are fully integrated in KICs\u2019 multiannual strategies. The RIS, steered by the EIT and implemented by KICs, has been run on a voluntary basis to date. From 2021, the RIS activities shall become mandatory and an integral part of the KICs\u2019 multiannual strategies. The EIT shall ensure that RIS activities are used as a bridge towards relevant research and innovation smart specialisation strategies. In addition, KICs shall enhance such integration through the establishment of RIS hubs. A RIS hub shall be established following a thorough needs analysis and an open call. It shall be part of the structure of the KICs and serve as focal point for their activities. Its objective is to mobilise and involve local knowledge triangle actors in the KICs\u2019 activities, establishing synergies at local level, identifying funding and collaboration opportunities and promoting their active integration in ecosystems. In accordance with the KIC expansion strategy, RIS hubs could pave the way to the establishment of a CLC in the targeted region. The EIT shall continue to provide guidance and support to KICs in the preparation and implementation of multiannual RIS strategies. RIS activities shall continue to support the innovation capacity of countries (and regions in those countries) that have modest and moderate innovation performances according to the EIS, as well as of the outermost regions within the meaning of Article 349 of the Treaty on the Functioning of the European Union, in order to foster their integration in the KICs\u2019 communities. The following are countries and regions eligible for RIS activities (RIS countries and regions): (1) the countries (and the regions in those countries) that are classified as either \u2018moderate\u2019 or \u2018modest\u2019 innovators in at least one of the three EIS annual reports issued in: (a) 2018, 2019 and 2020 for 2021-2024; and (b) in 2021, 2022 and 2023 for 2025-2027; and (2) the outermost regions. The EIT budget devoted to implementing RIS activities shall be at least 10 % and a maximum of 15 % of the overall EIT funding for existing and new KICs, thereby allowing an increase in the number of KIC partners from targeted regions. Activities supported through the RIS shall aim to: (1) contribute to improving the innovation capacities of regional and local ecosystems across the Union, via capacity building activities and closer interactions between the local innovation actors, such as clusters, networks, public authorities, HEIs, research organisations, vocational education and training providers and SMEs, as well as the activities of those actors; (2) support the objective of attracting new partners in the KICs and link local innovation ecosystems to pan-European innovation ecosystems; and (3) leverage additional private and public funding, with particular attention to ESIF. 3.3. Launch of new KICs In order to contribute to addressing new and emerging global challenges, the EIT shall launch open and transparent calls for proposals to create new KICs in priority fields selected among thematic areas of strategic importance and based on criteria assessing, inter alia, their relevance to the Union policy priorities with regard to addressing global and societal challenges, and their potential and added value to be addressed through the EIT model. The launch of new KICs shall take into account the strategic planning of Horizon Europe and the budget allocated to the EIT for the period from 1 January 2021 to 31 December 2027. The relevant selection criteria for European Partnerships set out in Annex III of Regulation (EU) 2021/695 shall be included in the KIC call for proposals and shall be assessed during the evaluation. Based on a proposal from the Governing Board and an analysis thereof, a first new KIC, in the field of Cultural and Creative Sectors and Industries (CCSI), is proposed to be launched as soon as possible in 2022 or 2023, with a call for proposals to be published if feasible in 2021. This priority field has the strongest complementarity with the eight existing KICs, as well as with the potential priority areas for other European Partnerships to be launched in the framework of Horizon Europe. A factsheet summarising the challenges in the CCSI field and the expected impact of the new KIC is included in Appendix 1. A second new KIC, in the field of Water, Marine and Maritime Sectors and Ecosystems (WMM), is proposed to be launched in 2026, with a call for proposals to be published in 2025. The Commission, with the assistance of independent external experts, shall carry out an ex-ante analysis by 2024 to evaluate the relevance of the WMM field. If the analysis results in a negative conclusion, the Commission may submit a proposal to amend SIA 2021-2027, taking into account the contribution of the Governing Board and the strategic planning of Horizon Europe. A factsheet summarising the challenges in the WMM field and the expected impact of the new KIC is included in Appendix 2. Other new KICs may be selected if budget allocations additional to those of the EIT become available and shall take into account the contribution of the Governing Board, the strategic planning of Horizon Europe and the criteria set for the selection of European Partnerships, in particular openness, transparency, Union added value, contribution to the SDGs, coherence and synergies. 3.4. Supporting the innovation and entrepreneurial capacity of higher education institutions In cooperation with the Commission, and after consulting the KICs, the EIT shall design and launch a pilot initiative supporting the innovation and entrepreneurial capacities of higher education institutions and their integration in innovation ecosystems (pilot higher education initiative), which will be implemented through the KICs, starting in 2021. Through the knowledge triangle integration model, the EIT is bridging the persistent gap between higher education, research and innovation. In particular, the EIT and the KICs are key tools for the development of human capital through their distinctive focus on innovation and entrepreneurial education. However, the impact of the EIT shall be further extended beyond the KICs\u2019 partners. HEIs across Europe need to be innovative and entrepreneurial in their approach to education, research, and engagement with businesses and the broader regional and local innovation ecosystem, including civil society, public institutions and third sector organisations, in the most inclusive and gender balanced way, which is possible to be achieved through a clear strategy, a methodological framework and commitment of resources. The KICs\u2019 activities relating to the pilot higher education initiative shall be implemented through open and transparent calls for proposals, which will aim to increase the innovation capacity in higher education, targeting mainly HEIs that are not KIC partners in innovation value chains and ecosystems across the Union. The activities shall address primarily the capacity development of HEIs, including: (1) the exchange and implementation of best practices in knowledge triangle integration, including organisational learning, training for up-skilling and re-skilling, coaching and mentoring; (2) the development of action plans on how to address identified needs in areas such as innovation management, start-up creation and development, technology transfer including intellectual property rights management, sustainability and climate neutrality by design, people and organisational management, the integration of gender approaches in innovation and engagement with local stakeholders and civil society; and (3) the implementation of innovation capacity development action plans and follow-up actions. Those activities shall involve other actors in the knowledge triangle, such as vocational education and training providers, research and technology organisations, SMEs and start-ups, and shall complement the intervention of the EIT on education as a core part of the knowledge triangle integration activities of the KICs. The EIT shall promote stronger cross-KIC collaboration within the pilot higher education initiative. The eligibility criteria to be included in the calls for proposals shall ensure that the majority of funding will go to HEIs from outside of the KICs. The aim of the pilot higher education initiative is that the impact of the EIT reach beyond the KICs and contribute to the EIT\u2019s core mission of boosting sustainable economic growth and competitiveness by reinforcing the innovation capacity of Member States, in line with the Horizon Europe goals of fostering entrepreneurial and innovation skills in a lifelong learning perspective, including increasing the capacities of HEIs across Europe. The EIT support shall also build on policy initiatives such as the HEInnovate (16) and RIIA (17) frameworks that have proven their value in a number of HEIs and Member States across the Union. The EIT shall design the support activities in close collaboration with the Commission, and after consulting the KICs, ensuring full coherence and complementarity with relevant activities within Horizon Europe, Erasmus+, established by Regulation (EU) 2021/817 of the European Parliament and of the Council (18), and other Union programmes. The specific details of the implementation and delivery mechanism process shall be further developed and fine-tuned in the first three years and shall be subject to monitoring and evaluation during this pilot phase. The evaluation of the pilot phase shall be conducted by independent external experts and the results shall be communicated to the Member State Representatives Group (MSRG) and to the European Parliament. Based on the results of that evaluation, the Governing Board shall decide whether the pilot higher education initiative is to be either continued and scaled-up or discontinued. The Governing Board shall steer and supervise the implementation and monitoring of the activities of the KICs. Particular attention shall be paid to ensuring an open and inclusive approach to attract HEIs beyond the KICs\u2019 partners aiming for wide geographical coverage; an inter-disciplinary and inter-sectoral approach; a broader participation of women in sectors where they are underrepresented; and a link with the RIS, relevant thematic platforms and smart specialisation strategies, and the Policy Support Facility when appropriate. The EIT shall strengthen and widen the scope of the EIT label beyond the KICs to include the HEIs participating in the action. With the involvement of actors from across the knowledge triangle, the EIT shall strive to link its support for developing innovation capacity in higher education to the EIT label, which is currently awarded to the KICs\u2019 education programmes. The EIT shall extend the EIT label to lifelong learning activities, such as mentoring, vocational training, skilling, re-skilling and up-skilling programmes, massive open online courses, involving and reaching out to a wider target group of students, adult learners and institutions, including vocational education and training institutions, beyond the KICs. The application of the EIT label beyond the EIT Community is expected to have a more structuring effect at all levels (individual, programme and institution). The EIT shall monitor the award and expansion of the EIT label to KICs\u2019 education and training programmes and explore a more effective quality assurance mechanism, including external recognition and accreditation of the EIT label. To ensure the success of the pilot higher education initiative, the EIT shall provide specific guidance, expertise and coaching to participating HEIs and target HEIs from across Europe, paying particular attention to HEIs from countries (and regions in those countries) that are moderate and modest innovators and other low performing regions that wish to develop their innovation capacities and strengthen their innovation footprint and smart specialisation strategies. 3.5. EIT cross-cutting activities 3.5.1. Communication and dissemination The EIT and the KICs shall strive to improve and reinforce their communication and visibility, and apply an improved branding strategy with regard to their main stakeholders in Member States and beyond, in line with the communication approach used with regard to Horizon Europe. With a growing number of KICs and the pilot higher education initiative, the EIT shall boost its efforts to increase the recognition of Union support as a quality brand for innovation. This brand management and improved communication is crucial, in particular with regard to citizens and national and regional authorities, as the innovations coming out of the EIT contribute to demonstrating the concrete impact of Union investments through Horizon Europe. The EIT shall strive to increase the use of existing Union information networks and provide coordination to their activities in order to ensure better advice and guidance to potential KIC partners. Such increased use and coordination may include the support of the national and regional authorities in identifying the necessary synergies with the multiannual strategies of the KICs. In order to ensure wider dissemination and better understanding of the opportunities offered by the EIT, the EIT shall reinforce guidance and assistance on aspects related to participation in KICs across Europe by building on existing networks of information and structures across Europe, in particular the National Contact Points referred to in Regulation (EU) 2021/695. In order to ensure that a large stakeholder community across the knowledge triangle at Union, national, regional and local level is aware of all EIT (and KIC) calls and funded projects, they will appear also in the European Funding and Tender Opportunities Portal, under Regulation (EU) 2021/695. The EIT shall organise regular meetings of the MSRG and of Commission related services, at least twice a year, to ensure appropriate communication and flow of information with Member States and at Union level. The European Parliament and the Council shall be kept duly informed of the performance, achievements and activities of the EIT and the KICs. In addition, the MSRG shall advise the EIT on strategically important issues. The MSRG, together with the EIT, shall ensure appropriate support to liaise and promote synergies about EIT-supported activities with national or regional programmes and initiatives, and share information about the potential national and regional co-financing of those activities. The EIT shall further increase the visibility of its action towards citizens and the EIT Community through the Stakeholder Forum (19), the EIT Awards and the EIT Alumni Community (20) with the aim of promoting the interactions with European actors of the knowledge triangle and recognise the most promising innovators and entrepreneurs in Europe. The EIT shall continue to steer and provide strategic guidance to the EIT Alumni Community (in collaboration with the EIT Alumni Board) to maximise its entrepreneurial and societal impact and the continuous involvement of its members in EIT-supported activities. In the course of 2021-2027 the EIT Alumni Community will continue to grow and will also include the alumni taking part in the actions supporting the innovation capacities of HEIs. 3.5.2. Identify and share good practices with stakeholders The EIT shall identify, codify, effectively share, and disseminate learning and good practices emerging from EIT-funded activities and, for that purpose, engage with Member State authorities at both national and regional level, with the Commission and the European Parliament, in particular with its Science and Technology Panel, establishing a structured dialogue and coordinating efforts. The KICs and the projects supporting innovation and entrepreneurial capacity of HEI are expected to be a valuable source of evidence and experimental learning for policy-makers in the field of research, innovation and higher education, as well as in different thematic domains. To date, the good practices and learning stemming from the KICs have not been pooled or codified sufficiently or disseminated effectively. The EIT shall further develop its role as an innovation institute with the ability to detect, analyse, codify, share and ensure the take-up of innovative practices, learning and results from the EIT-funded activities (support for education and training, research and innovation and entrepreneurship) on a broader scale. That EIT activity shall build on the links and synergies with the other initiatives within Horizon Europe, in particular the EIC, the missions and the European Partnerships. 3.5.3. International cooperation and global outreach activities The EIT shall develop broad lines of international cooperation of the EIT and the KICs under the supervision of the Governing Board, in compliance with the Horizon Europe approach to international cooperation as referred to in Regulation (EU) 2021/695 and other relevant Union policies, and in consultation with the respective Commission services. The EIT shall seek to ensure that its activities have a greater impact through international cooperation and shall coordinate international EIT-funded activities by the KICs. Its focus shall be to align closely with relevant policy objectives of the Union as well as its research and innovation priorities, and to ensure Union added value. When a physical presence of the EIT Community in a third country is deemed to be necessary to increase the impact and deliver more efficiently on its objectives, the EIT shall ensure coordination of the intervention, and provide incentives for joint KIC efforts. In its international cooperation and global outreach activities, the EIT, in cooperation with the Commission, shall focus on effective tackling of global challenges, contributing to relevant international initiatives and the SDGs, ensuring access to talent and enhanced supply and demand of innovative solutions. The EIT shall closely monitor those activities and ensure that they comply with the Horizon Europe approach to international cooperation as referred to in Regulation (EU) 2021/695 and other relevant Union policies. 3.6. Making it work: mode of operation This section includes a number of measures that aim to adapt and improve the current functioning of the EIT and the KICs. An effective, empowered and strategic Governing Board shall monitor the implementation of those measures at the EIT level, and shall provide the necessary incentives and control, including through the performance-based funding allocation process, to ensure that the KICs implement them. 3.6.1. KIC operational model The EIT shall ensure that the implementation of the KICs is in full compliance with the relevant requirements provided for in Regulation (EU) 2021/695, including ensuring the transition of the eight existing KICs towards the delivery of the new implementation criteria for European Partnerships set out in that Regulation. Therefore, the EIT shall provide strengthened operational guidance to the KICs and continuously monitor the KICs\u2019 performance to ensure compliance with sound management, good governance, monitoring and evaluation principles set out in Regulation (EU) 2021/819, as well as the principles and criteria for European Partnerships set out in Regulation (EU) 2021/695 and alignment with the requirements stemming from Horizon Europe priorities and indicators in order to maximise their performance and impact, based on a long-term collaboration strategy between the EIT and the KICs. Appropriate corrective measures shall be taken if a KIC underperforms, delivers inadequate results, fails to achieve the expected impact or lacks Union added value. The EIT shall ensure that the measures ensuring continuous openness of the KICs to new members as well as transparency during implementation be improved, in particular by adopting and applying transparent, clear and consistent accession and exit criteria for new members that add value to the partnerships, as well as other provisions such as transparent procedures for preparation of their business plans, and by systemically monitoring the KICs\u2019 activities. The KICs shall also run their activities in a fully transparent way, including through open calls for identifying and selecting their projects, partners and other activities and shall remain open and dynamic partnerships that new partners across the Union, including an increasing share of SMEs and start-ups, that add value to the partnership are able to join on the basis of excellence and innovation relevance. In order to limit the concentration of funding and ensure that the KICs\u2019 activities benefit from a wide network of partners, the procedure for the preparation of their business plans (including the identification of priorities, the selection of activities and the allocation of funds) and related funding decisions shall be made more transparent and inclusive. The KICs\u2019 multiannual strategies shall address the expansion of the partnership, including the establishment of new CLCs for which the Governing Board shall allocate an adequate budget. When deciding on the funding, the Governing Board shall take into account the progress towards the targets indicated in the multiannual strategies, inter alia, the number of CLCs. KICs shall make broader use of competitive funding mechanisms and increase the openness of calls, in particular for projects that are open to third parties. All those measures will increase the number of participating entities involved in the KICs\u2019 activities. Finally, the KICs shall report on the involvement of new partners in their regular reporting as one of the elements of their performance-based funding. As KICs operate across the entire value chain of innovation, they shall ensure an appropriate and continuous balance between the three sides of the knowledge triangle and related activities in their business plan portfolio. The EIT shall monitor the KICs\u2019 operations to ensure that they are implemented through a lean, efficient and cost-effective structure that keeps administrative, management and overhead costs to a minimum. The EIT shall ensure that the KICs achieve their expected impacts through a broad range of activities, identified in their business plans, which effectively support the fulfilment of their objectives, including their potential impact on innovation ecosystems at Union, national, regional and local level. Commitments from each KIC\u2019s partner shall be ensured by regularly monitoring the actual partner\u2019s contributions against the original commitments. The EIT shall ensure that the KICs have a risk management system in place for cases where some partners are not able to meet their original commitments. In pursuing the financial sustainability of their activities, the KICs shall look to a wide range of revenue and investment sources. To that end, the KICs shall ensure that the conditions of access to the partnership remain attractive to a wide range of potential partners. Any membership or tuition fees should not constitute a barrier for the participation of relevant partners in a KIC, in particular for SMEs, start-ups and students. 3.6.2. KIC funding model Through a lean and simplified funding model, the EIT is expected to enhance the impact of the KICs and their contribution towards reaching the objectives of the EIT and Horizon Europe, as well as encourage the commitment of the KICs\u2019 partners. In order to increase the added value of its support, the EIT shall adapt its funding model. The EIT shall make best efforts to facilitate a smooth transition between MFF periods, in particular for the ongoing activities. There are three main areas where the EIT shall implement improvements. First, the EIT shall gradually decrease the funding rate for KIC added-value activities (21) in order to increase the levels of private and public investments other than revenues from their partners. The adaptation of the funding model is expected to facilitate the ability of the KICs to manage the transition towards financial sustainability. It is expected that KICs be encouraged to gradually decrease the share of EIT funding in their business plan during the duration of the partnership agreements, while increasing the level of co-investment from non-EIT sources. Decreasing EIT funding rates for KIC added-value activities shall be applicable across phases of the KICs\u2019 entire life cycle (start-up, ramp-up, maturity, exit from the EIT grant), as presented in the following table: Start-up Ramp-up Maturity Exit from EIT grant Years 1 \u2013 4 5 \u2013 7 8 \u2013 11 12 \u2013 15 EIT funding rate Up to 100 % Up to 80 % Up to 70 % Up to 50 % at year 12, decreasing by 10 % per annum Figure 1: EIT funding rates 2021-2027 The activities of some of the KICs, due to their specific nature, might need extra incentives to be performed. To that end, the Governing Board might decide to apply more favourable funding conditions for cross-KIC activities, RIS activities and the pilot higher education initiative. Second, the EIT shall ensure that the grant allocation process will follow a performance-based funding model. The use of multiannual grants shall be increased to the extent possible. The EIT funding shall be directly tied to progress made in the areas listed in Article 10 and Article 11(5) of Regulation (EU) 2021/819 and to the KICs\u2019 objectives as laid down in their business plans, and could be reduced, modified or discontinued in the event of a lack of results. The EIT shall, inter alia, provide stronger incentives to the KICs to strive for new partners and shall take corrective measures, in particular based on the KIC\u2019s individual performance, in order to ensure the highest level of impact. Third, the EIT shall apply strict rules for reinforcing the comprehensive assessment mechanism prior to the expiry of the initial seven-year period of the KIC\u2019s operations in accordance with Articles 10 and 11 of Regulation (EU) 2021/819. That comprehensive assessment, to be undertaken with the help of independent external experts, shall be in line with best international practice and with the monitoring and evaluation criteria for European Partnerships set out in Regulation (EU) 2021/695. It shall take place before the expiry of the initial seven-year period. As a result of the comprehensive assessment, the Governing Board shall decide to continue, modify or discontinue (thus not extending the partnership agreement with that KIC) the financial contribution to a KIC and reallocate the resources to better performing activities. The Governing Board shall seek the opinion of the MSRG prior to adopting that decision. 3.6.3. Reducing the administrative burden The EIT shall intensify its efforts towards simplification in order to reduce the administrative burden on the KICs, allowing the implementation of their business plans and multiannual strategies in an agile and efficient way. Such simplification may include the use of lump sum or unit costs for relevant KIC activities. Moreover, in order to provide for better planning of resources, in particular of innovation activities, as well as facilitate stronger commitment and long-term investment from participating partners in the activities of the KICs, the EIT shall sign multiannual grant agreements with KICs, when appropriate including provisions for performance-based funding, under the respective partnership agreements. Those multiannual grant agreements shall not exceed three years. 3.6.4. EIT relation with KICs after the termination of the partnership agreement The EIT shall develop the general principles for the relation with KICs after the termination of the partnership agreement in line with the framework for European Partnerships provided for in Regulation (EU) 2021/695. Based on an in-depth independent study, to be conducted by the end of 2023, the EIT shall establish, in close cooperation with the Commission, the overall framework for its relations with the KICs whose partnership agreement is terminated or expired in the course of the 2021-2027 programming period. That in-depth independent study shall include an assessment of the KIC\u2019s efforts to achieve financial sustainability, the revenues generated and KIC\u2019s financial outlook and shall identify any activities, the continuation of which might be at risk due to a lack of resources. Subject to a positive outcome of a final review, the EIT may conclude a memorandum of cooperation (22) with a KIC, aiming to maintain active cooperation with it after the termination of the partnership agreement. The memorandum of cooperation shall include: (a) rights and obligations linked to the continuation of the knowledge triangle activities as well as the maintenance of the KIC\u2019s ecosystem and network; (b) conditions for the use of the EIT brand and participation in EIT Awards and in other initiatives organised by the EIT; (c) conditions for the participation in higher education and training activities including the use of the EIT label for education and training programmes and relations with the EIT Alumni Community; (d) conditions for participation in EIT competitive calls for some specific activities, including cross-KIC activities and shared services; (e) conditions for additional support from the EIT for transnational coordination activities among the CLCs with a high Union added value. Taking into account the results of an in-depth independent study, the Governing Board shall establish the duration, content and structure of the memorandum of cooperation, including the specific activities of the KICs that can be supported under points (a) to (e) of the second paragraph. The KICs shall be entitled to participate in the activities of the EIT in accordance with the conditions set out in the memorandum of cooperation, including the participation in competitive calls. 3.7. Synergies and complementarities with other Union programmes Building on its broad scope of action and distinctive role as an integral part of Horizon Europe, the EIT is well placed to create synergies and provide complementarities, while avoiding duplications, with other Union programmes or instruments, including by reinforcing its support for KICs in their planning and implementing activities. The EIT is expected to contribute to synergies in the mid to long term, inter alia with regard to the following: Erasmus+ \u2014 The EIT shall seek to establish synergies between Erasmus+ and EIT communities. Cooperation is to be geared towards ensuring access for Erasmus+ students participating in KIC partner HEIs to KIC summer schools or other relevant training activities (for instance, on entrepreneurship and innovation management) and establishing contacts with the KICs\u2019 alumni network. \u2014 Cooperation activities may also include delivery of training by the EIT or the KICs to academic staff (from any HEIs, beyond the KICs) for curricula integrating entrepreneurship and innovation, as well as testing, adoption and scaling-up of innovative practices developed within Erasmus+ networks (such as the alliances for innovation between HEIs and businesses) by KICs and vice versa. \u2014 Synergies are to be ensured, where possible, with the European Universities initiative that could help mainstream the EIT\u2019s education activities to reach a systemic impact. Digital Europe Programme, established by Regulation (EU) 2021/694 of the European Parliament and of the Council (23) \u2014 The KICs, in particular the CLCs, shall collaborate with the European Digital Innovation Hubs in accordance with Regulation (EU) 2021/694 to support the digital transformation of the industry and public sector organisations. \u2014 Feasibilities shall be explored to use infrastructures and capacities developed under the Digital Europe Programme (such as data resources and libraries of artificial intelligence algorithms and high performance computing competence centres in Member States) by the KICs in education and training, as well as for testing and demonstration purposes in innovation projects. Cohesion Policy Funds (in particular the European Regional Development Fund and the Cohesion Fund, established by a Regulation of the European Parliament and of the Council on the European Regional Development Fund and on the Cohesion Fund and the European Social Fund Plus, established by a Regulation of the European Parliament and of the Council on the European Social Fund Plus (ESF+)) \u2014 The KICs, through the CLCs and RIS hubs, shall promote regional and cross-regional cooperation between the knowledge triangle actors and managing authorities, in synergy with interregional cooperation and investments along value chains in related smart specialisation priority areas, and the work of the thematic smart specialisation platforms. Such cooperation with managing authorities may lead to including KIC activities in the operational programmes. The EIT shall also explore contributing to the skills development initiatives under the Cohesion Policy Funds through the exchange of best practices. \u2014 The EIT shall promote the collaboration between relevant KICs and the smart specialisation platforms, in order to facilitate synergies between EIT resources, Cohesion Policy Funds and other Union, national and regional programmes. The aim is to reach a broader representation of EIT activities across the Union, to strengthen links with smart specialisation strategies and to better use the RIS to leverage ESIF in EIT and KIC activities. InvestEU Programme \u2014 The KICs shall seek the collaboration of the InvestEU Advisory Hub to provide technical support and assistance to KIC-backed ventures for the preparation, development, and implementation of projects. \u2014 The KICs shall strive to contribute to feed the InvestEU Portal in order to bring investors and financial intermediaries closer to KIC-backed ventures, in close collaboration with Commission services and in synergy with the EIC. Creative Europe Programme, established by Regulation (EU) 2021/818 of the European Parliament and of the Council (24) The Creative Europe Programme is relevant, inter alia, to the activities of a new KIC on CCSI. Strong synergies and complementarities are to be developed with the Creative Europe Programme in areas such as creative skills, jobs and business models. Single Market Programme, established by Regulation (EU) 2021/690 of the European Parliament and of the Council (25). KICs shall seek cooperation with the Enterprise Europe Network (EEN) and its Sector Groups to facilitate business-to-business cooperation, technology transfer and innovation partnerships for entrepreneurs wishing to develop their activities across the Union and beyond in accordance with Regulation (EU) 2021/690. EEN organisations will promote the KICs\u2019 activities among their SME clients. The EIT shall explore cooperation on the mobility programmes for new entrepreneurs to improve their entrepreneurial skills. 4. TACKLING THE CRISIS RESULTING FROM THE OUTBREAK OF COVID-19 Major social, economic, environmental and technological changes arising from the COVID-19 crisis will require the collaboration of all Union institutions, bodies, offices and agencies. The EIT should contribute to the necessary innovation efforts by providing a coherent response to the COVID-19 crisis. The EIT will ensure that the KICs support and promote the delivery of innovative solutions in different fields of action in accordance with the priorities of the Recovery Plan for Europe, the European Green Deal, the New Industrial Strategy for Europe and the SDGs, thus contributing to the recovery of Europe\u2019s societies and economy and strengthening their sustainability and resilience. In particular, the EIT should ensure that the KICs are able to operate with the necessary flexibility to adapt to the challenges arising from the COVID-19 crisis, as well as to new and unexpected challenges and priorities. Under the supervision and control of the EIT, the KICs could create measures that are fit for the purpose of supporting and increasing the resilience of their ecosystems, namely their partners and beneficiaries and beyond their existing communities. Specific attention should be paid to actions aiming to increase the resilience of microenterprises, SMEs and start-ups, as well as students, researchers, entrepreneurs and employees who have been hit particularly hard by the COVID-19 crisis. The KICs are also invited to exploit synergies with other Union initiatives and partnerships, with a view to supporting the strength of Europe\u2019s innovation ecosystems. In adapting to the new situation, the KICs may make use of innovative collaborative tools, instruments, information and support services to ensure collaboration and interaction within their communities. The EIT, seeking synergies with other Union programmes and agencies, may propose initiatives based on the integration of the knowledge triangle aiming to support innovation ecosystems in the Union. To that end, the EIT may promote new cross-KIC activities to tackle challenges arising from the COVID-19 crisis. 5. RESOURCES 5.1. Budget needs The EIT\u2019s budget needs in the period 2021-2027 are EUR 2 965 000 000 and are based on three main components: (1) expenditure for the existing eight KICs (reflecting that for three of them the partnership agreements will come to an end by 2024) and the launch of two new KICs (one in 2022 or 2023 and a second one in 2026); (2) EIT administrative expenditure; and (3) expenses for preparation, monitoring, control, audit, evaluation and other activities and expenditures necessary for managing and implementing the activities of the EIT, as well as evaluating the achievement of its objectives in accordance with Article 12(6) of Regulation (EU) 2021/695. Around EUR 2 854 000 000 (96 % of the total EIT budget) is envisaged to fund existing and new KICs of which: (a) at least 10 % and a maximum of 15 % shall be dedicated to the RIS; (b) a maximum of 7 % shall be dedicated to cross-KIC activities, including support for KICs for which the partnership agreement is expired or terminated; (c) a maximum of 3 % shall be dedicated to a pilot higher education initiative of three years. Through the introduction of a gradually decreasing EIT funding rate, the KICs are expected to mobilise a further EUR 1 500 000 000 of other public and private sources. The budget for the launch of two new KICs (one to be launched as soon as possible in 2022 or 2023 and a second to be launched in 2026) will be around EUR 300 000 000. If budget allocations additional to those of the EIT become available, the EIT may launch additional KICs. The EIT shall continue to be a lean and dynamic organisation. The costs of EIT administrative expenditure, covering necessary staff, administrative, infrastructure and operational expenses, shall, on average, not exceed 3 % of the EIT budget. Part of the administrative expenditure is covered by Hungary through the provision of office space free of charge until the end of 2029. To that end, a major effort shall be made to decrease the KICs\u2019 administrative costs which, in any event, shall be kept to a reasonable minimum. 5.2. Impact (monitoring and evaluation) The measurement of the EIT\u2019s impact is expected to be continuously improved over the next programming period taking into account the lessons learnt and the experiences gained so far and the need to streamline its practices with those of Horizon Europe. The EIT shall apply an evaluation, reporting and monitoring framework in accordance with Articles 10, 11 and 20 of Regulation (EU) 2021/819, ensuring coherence with the overall approach taken for Horizon Europe while catering for flexibility. In particular, feedback loops between the Commission, the EIT and the KICs shall be improved in order to address the objectives in a consistent, coherent and efficient manner. 5.2.1. Reporting and monitoring The EIT shall improve its current monitoring system and introduce a reporting and monitoring framework including key performance indicators, aligned with the impact pathway indicators of Horizon Europe. The reporting and monitoring of the KICs\u2019 operational performance, including their administrative expenditure and their results, will be a primary task of the EIT and shall be implemented in cooperation with Horizon Europe common corporate services within the Commission. The reporting and monitoring system for the KICs shall be built into the overall Horizon Europe monitoring system, in particular by implementing common data models including data collection stored in the Horizon Europe database. The Commission shall take part in the co-design of all relevant impact and monitoring indicators and tools developed or applied by the EIT in order to ensure coherence with the overall Horizon Europe monitoring system, including the impact pathway indicators, the criteria for European Partnerships and the strategic planning of Horizon Europe. Continuous monitoring procedures, as well as interim review and comprehensive assessment procedures, including the establishment of a sound set of quantitative and qualitative indicators and their related baseline and targets, shall be established by the Governing Board. Furthermore, the EIT shall take into account the deployment of the innovation radar methodology in Horizon Europe, and shall explore how innovation radar could be leveraged by the KICs in order to enhance its monitoring activities. The results of such monitoring shall feed into the KICs\u2019 multiannual business planning processes and determine the allocation of the EIT\u2019s performance-based funding of the KICs\u2019 activities and the preparation of the partnership agreements and grant agreements with the KICs as beneficiaries. Furthermore, the results of the monitoring of the KICs is expected to feed into the strategic coordinating process for the European Partnerships. The EIT\u2019s activities, including those managed through the KICs, are expected to have: (1) a technological, economic and innovation impact by influencing the creation and growth of businesses, as well as the creation of new innovative solutions to address global challenges, creating direct and indirect jobs and mobilising additional public and private investments; (2) a scientific and educational impact by strengthening human capital in research and innovation, enhancing innovative and entrepreneurial skills both at individual and organisational levels and fostering the creation and diffusion of knowledge and innovation openly within society; (3) a societal impact, including an impact derived by the delivery of systemic solutions within and beyond the EIT Community, also through cross-KIC activities, by addressing Union policy priorities in the fields of climate change (such as mitigation, adaptation and resilience), energy, raw materials, health, added value manufacturing, digital, urban mobility, food, culture and creativity, or water through innovative solutions, engagement with citizens and end-users and by strengthening the uptake of innovative solutions in those areas of society. The EIT shall ensure the development of specific societal indicators in the areas of activity of the KICs and shall carry out regular monitoring in line with the Horizon Europe framework for societal impact. The impacts referred to in the third paragraph shall be measured, inter alia, in accordance with the impact pathway indicators set out in Annex V to Regulation (EU) 2021/695. Additional indicators, including societal impact indicators in the areas of activity of the KICs, shall be developed by the EIT together with the Commission in line with the development of the Horizon Europe indicator framework and shall reflect the overall approach for European Partnerships to contribute to scientific, economic and societal impact. The alignment of the impact indicators with Horizon Europe aims to monitor progress towards the EIT\u2019s objectives over time, ensuring a comparative evidence-base on results and impacts generated by the KICs vis-\u00e0-vis Horizon Europe. In addition, the EIT shall ensure that the monitoring system captures progress in relation to activities specific to the KIC model, such as knowledge triangle integration and entrepreneurial skills. The indicators on EIT education-related activities (including those supporting the capacities of HEIs) shall monitor for example: (1) human capital skill acquisition and HEI engagement and capacity improvement (short term); (2) career and the role and performance of HEIs in local innovation ecosystems (medium term); and (3) working conditions and the role and performance HEIs in local innovation ecosystems (long term). The continuous monitoring of the KICs shall be performed in an efficient way and address, inter alia, the following: (1) progress towards financial sustainability in particular leveraging new sources of investments; (2) progress towards pan-European coverage and openness, as well as transparency of governance; (3) effectiveness in business acceleration (namely, created and supported high-growth ventures); (4) each KIC\u2019s administrative and management costs; (5) the operations of CLCs and the RIS hubs and entities and their integration in the local innovation ecosystems; (6) the implementation of education and training activities, including the extended use of the EIT label. The following table sets out a non-exhaustive list of key performance indicators and targets that are expected to be monitored by the EIT in the period 2021-2027. Those indicators provide the main input and output orientations for monitoring the achievement of the EIT\u2019s key objectives for 2021-2027, such as fostering innovation and entrepreneurship through better education, increasing its regional and local impact and openness towards potential partners and stakeholders, ensuring balance between revenues and costs, establishment of new CLCs and bringing new innovative solutions to global challenges to market. EIT Management Indicators Target 2023 (baseline 2020) Target 2027 (baseline 2020) Number of entities/organisations participating in activities of the EIT and the KICs 20 % increase 50 % increase Number of innovations (products and services) launched on the market 1 500 4 000 HEIs involved in activities of the EIT and the KICs 285 680 Number of students involved in education activities of the EIT and the KICs 8 500 25 500 Number of start-ups supported 300 700 KICs\u2019 funding EUR 700 000 000 EUR 1 500 000 000 Number of entities/organisations participating in activities of the EIT and the KICs from regions outside the KICs\u2019 CLC regions 50 % increase 100 % increase In order to improve openness and transparency, the EIT shall ensure that the project data collected through its internal monitoring system, including the results from the KICs, is fully accessible and integrated in the overall data management system of Horizon Europe. The EIT shall ensure that detailed information arising from its monitoring and evaluation process is made available in a timely manner and is accessible in the Horizon Europe database. In addition, the EIT shall ensure dedicated reporting on quantitative and qualitative impacts, including on committed and actually provided financial contributions. 5.2.2. Evaluation, interim review and comprehensive assessment The periodic independent evaluations of EIT activities, including those managed through the KICs, shall be carried out by the Commission in accordance with Regulations (EU) 2021/819 and (EU) 2021/695. In accordance with Article 20 of Regulation (EU) 2021/819, the interim evaluation shall assess, inter alia, the result and impacts of the pilot higher education initiative, the effectiveness of the KICs\u2019 financial sustainability strategies, the impact of RIS activities and the collaboration between the EIT and the implementing bodies under Pillar III \u2018Innovative Europe\u2019 of Horizon Europe. In that respect, the EIT evaluations shall, in particular, assess the effectiveness, efficiency, relevance, coherence and Union added value of the EIT activities, including through the KICs. They shall be carried out by the Commission, with the assistance of independent external experts, and they shall feed into the Horizon Europe evaluations carried out by the Commission, also in view of a systemic assessment of the Pillar III \u2018Innovative Europe\u2019 of Horizon Europe, in particular with respect to the one-stop shop for innovation. Each KIC shall be subject to a comprehensive assessment conducted by the EIT, under the supervision of the Governing Board and with the support of independent external experts, before the end of the seven-year period of the partnership agreement, as well as to a final review before its end. On the basis of a comprehensive assessment, the Governing Board shall decide on whether to extend the partnership agreement beyond the first seven years, while the final review shall be used as a basis on which to negotiate a possible memorandum of cooperation. When conducting those evaluations, in accordance with Article 11(5) of Regulation (EU) 2021/819, the Governing Board shall take into account the implementing, monitoring and evaluation criteria for the European Partnerships set out in Regulation (EU) 2021/695, the achievement of the KIC\u2019s objectives, its coordination with other relevant research and innovation initiatives, its level of financial sustainability, its capacity to ensure openness to new members, the transparency of its governance, and its achievement in attracting new members, within the limits of the Union contribution referred to in Article 21 of Regulation (EU) 2021/819, the Union added value and relevance with regard to the objectives of the EIT. In addition, in accordance with Article 11(2) of Regulation (EU) 2021/819, the EIT shall, under the supervision of the Governing Board, conduct interim reviews of the KICs\u2019 performance and activities covering their first three years of the partnership agreement (namely, the KICs\u2019 start-up phase) and, if it is the case, the three years following its extension (namely, the maturity phase). Those reviews shall be based on the continuous monitoring performed by the EIT. They shall help the Governing Board to get early indications on the KICs\u2019 performance with respect to their strategy and targets, as well as compliance with Governing Board indications. In accordance with Article 11(6) of Regulation (EU) 2021/819, in the event that the continuous monitoring, an interim review or the comprehensive assessment of a KIC shows inadequate progress in areas referred to in Article 10 of that Regulation or a lack of Union added value, the Governing Board shall take appropriate corrective measures. The corrective measures may take the form of a reduction, modification or withdrawal of the EIT\u2019s financial contribution or the termination of a partnership agreement, as well as binding recommendations related to the KIC\u2019s activities, or suggestions for adaptations of its delivery and operational models. The results of those interim reviews and evaluations shall be made publicly available, communicated to the European Parliament and to the Council and reported to the strategic coordinating process for European Partnerships. Appendix 1 Factsheet on the KIC on Cultural and Creative Sectors and Industries (CCSI) I. The Challenge A KIC on CCSI (26) can bring a horizontal solution to an array of rising challenges, which are of a permanent nature and may be addressed through education, research and innovation activities. Those challenges may be grouped into four pillars: (1) European creativity, cultural and linguistic diversity; (2) European identity and cohesion; (3) European employment, economic resilience and smart growth; and (4) Europe as a global actor. European creativity and cultural diversity depends on resilient and robust CCSI. However those sectors are facing a number of challenges as a result of the increased competition from global players and the digital shift. \u2014 Producers, creators, distributors, broadcasters, cinema, theatres and all types of cultural organisations and businesses need to innovate in order to attract new audiences and expand, and to develop new processes, services, contents and practices that provide societal value. \u2014 The shortage of entrepreneurship and cross-cutting skills in cultural and creative sectors (27) concerns both emerging sub-sectors and very mature ones that undergo a profound digital transformation. Those skills are needed for innovation and are crucial in light of labour market changes that the sector is facing. \u2014 Cultural heritage is an undisputed expression of cultural identity, an important public good and a source of innovation, providing good return on investment and significant economic revenues, but its potential is still largely untapped. As a catalyst for sustainable heritage-led regeneration and an essential stimulus to education and lifelong learning, fostering cooperation and social cohesion, it is likely to benefit greatly from a KIC on CCSI. Societal challenges related to European identity and cohesion can generally be described in terms of a lack of \u2018bridges\u2019 connecting different parts of society and connecting different territories. They include issues related to social exclusion, the need to build closer intercultural links, protect linguistic diversity, including minority languages, and develop a sense of common belonging based on our cultural diversity and common heritage that could be addressed through more inclusive and accessible community participation, innovations in design, architecture and the use of public spaces, as well as culture-led societal innovation. In particular: \u2014 there is limited cooperation among researchers, between research and industry, and between public and third sector organisations, as well as insufficient coordination and unnecessary duplication of research and development efforts, sharing of methods, results, and best practices; \u2014 the level of integration of creative clusters and innovation hubs is insufficient; \u2014 a significant share of regional smart specialisation priorities in Europe refers to culture under different angles (such as cultural heritage, creative industries and the arts); \u2014 given the important role of culture and creativity for the economic and social development of cities and regions and their ability to further help address disparity issues across Europe, the potential of a KIC on CCSI is high. Current challenges related to European employment, economic resilience, and smart growth, include socio-economic issues such as tackling unemployment (in particular youth unemployment), improving skills and working environments and facing global competition. \u2014 There is a high market concentration: in 2013, around 50 % of the total Union turnover and added value was generated in the United Kingdom, Germany and France. \u2014 Globalisation, digitisation and technological innovation have a strong impact on European industries. Those developments have changed the way in which artists produce and distribute their works and relate to their audiences, changing the traditional business models of CCSIs, and they have fundamentally altered consumer expectations and behaviour. In addition, the increasing power of non-European content production companies has had a huge impact on the traditional value chain. \u2014 Creative, cultural and artistic productions often face the challenge of monetising their output and products, thereby creating highly precarious areas of work. New innovative ways of supporting micro, small and medium-sized creative and cultural organisations and enterprises are to be found. The role of Europe as a global actor includes the need to enhance the dissemination of European cultural content. Europe needs to remain competitive in the global digital race for the creation of new technologies (such as Artificial Intelligence, the Internet of Things and blockchain) for which CCSI are important generators of content, products and services. Moreover, on a global scale, CCSI (such as design and architecture) contribute actively to the sustainable development and drive green innovation, while cultural content (literature, film and the arts) can, in addition to its intrinsic value, raise awareness of ecological problems and inform public opinion. II. Relevance and impact A KIC on CCSI \u2013 with its holistic and integrated approach \u2013 will help address all the challenges set out in Section I. By covering nearly all sectors of our lives, society and economy, that KIC is likely to be highly relevant in terms of its economic and societal impact, unlocking strategic opportunities for economic, technological and social innovation. It is also likely to be instrumental in allowing HEIs in the arts to play a more active role in developing hybrid competences and an entrepreneurial mindset that better meets the needs of industry. Culture-based and creativity-driven innovations boost European competitiveness either directly by creating new enterprises and jobs or indirectly by creating cross-sector benefits to the wider economy, improving quality of life and increasing the attractiveness of Europe. Cultural and creative sectors (such as cultural heritage and the arts) are increasingly seen as new sources of smart, sustainable and inclusive growth and jobs. Those sectors are already employing more than 12 million people in the Union, which amounts to more than 7,5 % of all persons employed in the Union. Cultural heritage is a key component of the cultural and creative sectors and a major contributor to the attractiveness of Europe\u2019s regions, cities, towns and rural areas. It is a driver for private sector investments, for talent attraction, for business generation and for direct and indirect job creation. The contribution of culture and creativity to innovation is increasingly driven by non-technological factors such as creativity, design and new organisational processes or business models. In particular, the sectors with distinct value chains (namely, music, the arts, design, fashion, audiovisual, video games and architecture) have a strong innovation capacity in economic terms and are able to drive innovation in other sectors of the economy. Culture and participation in cultural activities have a direct impact on the well-being of citizens and social inclusion. Cultural and creative industries enhance societal values of identity, democracy and community participation. Culture has a great potential to reinforce a European sense of belonging, where diversity represents an asset. This is of fundamental importance to enable resilience, social access, societal cohesion, anti-radicalisation and gender equality, and to tackle Europe\u2019s political uncertainties and the need for unity. A KIC on CCSI is to empower network opportunities, collaboration, co-creation and knowhow transfer between education, research, business, public and third-sector organisations, within the cultural and creative sectors and with other sectors of the society and the economy. It is intended to: \u2014 catalyse bottom-up and top-down initiatives at Union, national and regional level. It will develop the necessary framework conditions for the creation and scale-up of new ventures in innovative ecosystems; \u2014 provide researchers and students in many disciplines (including the arts, humanities, social sciences, applied hard sciences and business) and entrepreneurs of the cultural and creative industries and other sectors with the knowledge and skills necessary to deliver innovative solutions and to turn them into new cultural, societal and business opportunities; and \u2014 allow further cross-fertilisation with other economic and industrial sectors, acting as an accelerator for innovation. III. Synergies and complementarities with existing initiatives A KIC on CCSI would be complementary to a number of other Union initiatives, as well as such at the level of Member States. The main synergies expected at Union level are presented in this Section. A KIC on CCSI is expected to establish strong synergies with relevant policy initiatives under Horizon Europe, and in particular under Pillar II \u2018Global Challenges and European Industrial Competitiveness\u2019 with the cluster \u2018Culture, Creativity and Inclusive Society\u2019 and its areas of intervention on cultural heritage and democracy. A KIC on CCSI could also provide valuable horizontal inputs across various activities to be carried out in the cluster \u2018Digital, Industry and Space\u2019, in particular as regards the manufacturing technologies in which the need to develop new products relies heavily on CCSI. Furthermore, it could efficiently complement other parts of Horizon Europe, the intervention of the existing EIT Digital and the actions planned under other Union programmes such as InvestEU Programme, Erasmus+, Creative Europe Programme, Digital Europe Programme or the Cohesion Policy Funds. The Creative Europe Programme will be highly relevant for the activities of a KIC on CCSI. The Creative Europe Programme elects strands and special calls reflecting some of the challenges facing the cultural and creative sector (such as skills and employment and business models) and aims to develop strong synergies and complementarities. Under the InvestEU Programme, and in the context of limited access to finance for the cultural and creative sectors, synergies are expected with the financial mechanism helping to scale up cultural and creative projects by providing insurance to financial intermediaries. The Smart Specialisation Strategy (S3 strategy) platform on Industrial Modernisation has identified a number of research and innovation strategies that focus on CCSI and explore new links between local assets, potential markets and societal challenges through the involvement of a large set of entrepreneurial actors. In particular, the promotion of new partnerships between research organisations, enterprises and public authorities is a major concern of the S3 strategy, calling for the set-up of new collaborative platforms. IV. Conclusion A KIC on CCSI is most suited to address the major economic and societal challenges referred to in this Appendix. Creativity is a key driver of innovation and a KIC on CCSI has the capacity to unleash the potential of artistic, culture-based creativity and to help strengthen Europe\u2019s competitiveness, sustainability, prosperity and smart growth. Appendix 2 Factsheet on the KIC on Water, Marine and Maritime Sectors and Ecosystems (WMM) This Appendix presents an overview of the WMM field at the time of preparation of the SIA 2021-2027. Prior to the launch of a KIC on WMM, the Commission shall perform an analysis to reflect developments in scientific, technological and socio-economic trends, and ensure: (1) full alignment with the strategic planning of Horizon Europe; (2) full alignment with the criteria for European Partnerships set out in Annex III of Regulation (EU) 2021/695; and (3) coherence with existing initiatives at Union, national and regional level, including European Partnerships and missions. I. The challenge Seas, oceans and inland waters play a central role in human life, health and wellbeing, in the provision of food, critical ecosystem services, renewable energy and other resources, as well as in climate-related dynamics and in the preservation of biodiversity. During the last 100 years, the overuse and mismanagement of natural resources have placed a great pressure on freshwater and marine ecosystems. Therefore, the creation of a circular and sustainable blue economy that develops within ecological limits and that is based on the reliable availability of an acceptable quantity and quality of water as well as on healthy and functioning freshwater and marine ecosystems is a challenge. That challenge encompasses mainly: (1) water scarcity, drought and floods; (2) marine and freshwater ecosystem degradation; and (3) the circular and sustainable blue economy. 1. Water scarcity, drought and floods Continued climate change and over-extraction of fresh water are increasing the severity and frequency of water scarcity and droughts. Without innovative methods and technologies to gather, predict, prepare and disseminate information and solutions about waterbody safety, potential threats and mitigation of risks, the Union is exposed to severe economic and social harm. Water scarcity accompanies the pressure on land driven by the need to increase biomass production, carbon sequestration and wilderness to achieve decarbonisation and biodiversity targets. The Commission\u2019s impact assessment (28) indicates that shifting protein production to non-fed aquaculture and to integrated multi-trophic aquaculture and aquaponics, could relieve pressure on land and freshwater. 2. Marine and freshwater ecosystem degradation Coastal, marine and freshwater ecosystems are subject to pressure from direct human activity and accelerating climate change. The damage includes the loss of biodiversity, the depletion of fish stocks, damage to the sea floor, including from the use of harmful devices such as fishing gear, obstruction of rivers, eutrophication pollution, and the accumulation of marine litter including a high level of fishing gear and microplastics that are discarded in the oceans. Poor ecological health not only compromises biodiversity targets but also harms those communities and businesses that depend on clean water and healthy ecosystems. The global market for goods and services for measuring and mitigating that degradation is growing and is highly competitive. Innovation that can enhance, restore and recover marine, coastal and freshwater capital and innovation into sustainable fishing gear and methods is key for the competitiveness of Union businesses and to supporting jobs and growth across the Union. 3. The circular and sustainable blue economy The circular economy path not only safeguards human health and resource efficiency, but is also an engine of sustainable growth. The planned unprecedented growth in offshore wind energy and other innovative ocean energy technologies, which must not undermine environmental protection, offer opportunities both for the enhancement of biodiversity (such as artificial reefs and oyster beds) and for new activities that make use of the space and renewable electricity such as aquaculture and hydrogen electrolysis. Non-fed aquaculture is able to recycle the excess nutrients that would otherwise cause eutrophication. New targets for emissions reduction and renewable fuel in maritime transport require innovation in propulsion and logistics. The reuse of wastewater prevents shortages that may be exacerbated by a changing climate. II. Relevance and impact A KIC on WMM \u2013 with a holistic and integrated approach \u2013 will help address the challenges referred to in Section I. This field has a relatively strong knowledge base and high market potential. European countries have produced more research papers on water science and technology in the past 15 years than both the United States of America and the rest of the world. Moreover, the Union, together with China and the United States of America, is one of the leading maritime economies. According to the most recent figures from 2018, the established sectors of the blue economy employed over five million people in the Union, and generated EUR 750 billion of turnover and EUR 218 billion of gross value added. However, there is a clear fragmentation of efforts and disconnections between education, research and innovation activities. For example, less than 20 % of research and development organisations in water sciences have an effective cooperation with industries or enterprises. Newly emerging innovation sectors (such as biotechnologies and offshore energy production) open new market opportunities for new technologies and new business and highly skilled jobs. Those sectors and the technological transition of the more traditional marine-related sectors would require trans-disciplinary approaches and new types of education across discipline boundaries. In particular, academic programmes tend to be rather broad, whereas the sectors require specific knowledge and skills. Additionally, curricula in areas such as engineering, urban design and architecture do not sufficiently cover issues related to ecology, marine engineering and management of water. Establishing a KIC on WMM is intended to comprise a real contribution to strengthening innovation ecosystems and stimulating cooperation across the knowledge triangle, in order to accelerate the uptake of new technologies and approaches and boost the development of more sustainable products and methods, in particular as far as fishing gear is concerned. The establishment of a pan-European multi-disciplinary community of knowledge triangle partners would help to promote the blue economy vision and boost worldwide competitiveness of European marine and maritime science and technology. Such a community would help bring to the market innovative projects of blue science and technology that would provide solutions to urgent practical challenges of sustainability and contribute to an \u2018Ecosystem-based Blue Economy\u2019 not only at a European but also at a global level. A KIC on WMM would lead to better management of human interactions with water-marine ecosystems directly contributing to a sustainable blue economy that develops within ecological limits, in particular by ensuring the sustainable management of marine ecosystems. III. Synergies and complementarities with existing initiatives The KIC on WMM shall establish the strongest possible synergies with relevant Union policy initiatives as well as within Horizon Europe, and interact at an international level with relevant UN initiatives and the SDGs, in particular SDG 6 \u2018Clean Water and Sanitation\u2019, SDG 11 \u2018Sustainable Cities and Communities\u2019, SDG 13 \u2018Climate Action\u2019 and SDG 14 \u2018Life below Water\u2019. The KIC on WMM shall be aligned with the priorities established in Directive (EU) 2020/2184 of the European Parliament and of the Council (29), Directive 2008/56/EC of the European Parliament and of the Council (30), Directive 2014/89/EU of the European Parliament and of the Council (31), Regulation (EU) No 1380/2013 of the European Parliament and of the Council (32), the communication of the Commission of 10 October 2007 on An integrated Maritime Policy for the European Union and international commitments. The KIC on WMM shall contribute to priorities established in the European Green Deal, in particular the \u2018Farm to Fork Strategy\u2019, the \u2018Zero pollution action plan for air, water and soil\u2019, the \u2018initiatives to increase and better manage the capacity of inland waterways\u2019 and the EU Biodiversity Strategy for 2030. Some regional S3 strategies have identified a number of research and innovation strategies that focus on marine and aquatic industries and explore new links between local assets, potential markets and societal challenges through the involvement of a large set of entrepreneurial actors. Strong complementarities with the components of Horizon Europe are to be ensured and duplications are to be avoided, in particular with: (1) the possible mission on \u2018healthy oceans, seas, coastal and inland waters\u2019; (2) relevant European Partnerships, in particular the ones on \u2018a climate-neutral, sustainable and productive Blue Economy\u2019, \u2018Rescuing biodiversity to safeguard life on Earth\u2019, \u2018Water4All\u2019, \u2018Clean energy transition\u2019, \u2018Driving urban transition\u2019, \u2018Food systems\u2019 and \u2018Research and Innovation in the Mediterranean Area\u2019 (Horizon 2020); (3) all clusters of Pillar II \u2018Global Challenges and European Industrial Competitiveness\u2019; (4) research infrastructures; and (5) the EIC. Strong complementarities with the European Investment Bank (EIB) and BlueInvest are also to be ensured for the uptake of promising innovations and duplications are to be avoided. IV. Conclusion The KIC on WMM is best suited to addressing the major economic, environmental and societal challenges referred to in this Appendix. That KIC is needed, in particular, to strengthen the innovation ecosystems throughout Europe tackling the water-related challenges, train the next generation of innovators and entrepreneurs, and find and support innovative solutions for those challenges. The KIC on WMM shall: (1) reduce the fragmentation of the water, maritime and marine sectors\u2019 innovation landscape by fostering the creation of innovation ecosystems that will connect actors and networks across sectors and disciplines at Union, national, regional and local level; (2) promote an integrated and multidisciplinary approach through collaboration among HEIs, research organisations, innovative businesses, public and third-sector organisations in the blue economy sectors in order to deliver on the Union objectives on green and digital transitions; (3) connect actors and networks across sectors and disciplines at Union, national regional and local level, in particular by identifying the relevant S3 strategy and further regional strategies which include blue economy sectors; (4) train and develop the next generation of innovators and entrepreneurs in the blue economy sectors by equipping them with the necessary entrepreneurial and technological skills needed for sustainable and competitive development; (5) contribute to the development of the appropriate framework conditions to transform ideas into new technological developments and social innovation, and to their market deployment in view of improving the quality of life and benefitting Union citizens; (6) establish synergies with other European Partnerships, missions, the EIC, the EIB and BlueInvest, in order to scale up innovations, allow other sectors to prosper in a sustainable manner and increase the market deployment and societal acceptance of innovative solutions; and (7) strengthen the Union\u2019s position as a global actor in ocean science, inland waters management and ecosystem protection and restoration. (1) Regulation (EC) No 294/2008 of the European Parliament and of the Council of 11 March 2008 establishing the European Institute of Innovation and Technology (OJ L 97, 9.4.2008, p. 1). (2) OJ L 282, 19.10.2016, p. 4. (3) As defined in point (2) of Article 2 of Regulation (EU) 2021/819. (4) As defined in point (3) of Article 2 of Regulation (EU) 2021/819. (5) As defined in point (16) of Article 2 of Regulation (EU) 2021/819. (6) As defined in point (7) of Article 2 of Regulation (EU) 2021/819. (7) As defined in point (6) of Article 2 of Regulation (EU) 2021/819. (8) As defined in point (10) of Article 2 of Regulation (EU) 2021/819 and Section 3.2 of this Annex. (9) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 \u2013 the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104). (10) As defined in point (4) of Article 2 of Regulation (EU) 2021/819. (11) As defined in point (2) of Article 2 of Regulation (EU) 2021/695. (12) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (13) Council Decision (EU) 2021/764 of 10 May 2021 on establishing the Specific Programme implementing Horizon Europe \u2013 the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (OJ L 167 I, 12.5.2021, p. 1). (14) As defined in point (8) of Article 2 of Regulation (EU) 2021/819. (15) As defined in point (14) of Article 2 of Regulation (EU) 2021/819. (16) HEInnovate is a policy framework developed by the Commission and the Organisation for Economic Co-operation and Development (OECD). HEInnovate offers HEIs a methodology to identify innovation capacity areas for further development and to shape relevant strategies and actions in order to achieve the desired impact. HEInnovate is based on sound methodological evidence with eight capacity development areas: Leadership and Governance; Digital Transformation; Organisational Capacity; Entrepreneurial Teaching and Learning; Preparing and Supporting Entrepreneurs; Knowledge Exchange; Internationalisation; and Measuring Impact. OECD has published a number of HEInnovate-based country reports, see OECD Skills Studies series athttps://www.oecd-ilibrary.org/education/ (17) The Regional Innovation Impact Assessment framework (RIIA) was developed by the Commission as a first step in guiding assessments of the innovation impact of universities through the elaboration of metrics based case studies. Assessing the innovation impact, e.g. through the RIIA framework, could potentially be tied to innovation performance based funding instruments at the Union, national or regional level. (18) Regulation (EU) 2021/817 of the European Parliament and of the Council of 20 May 2021 establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 (see page 1 of this Official Journal). (19) As defined in point (11) of Article 2 of Regulation (EU) 2021/819. (20) The EIT Alumni Community brings together entrepreneurs and change agents who have participated in an education or entrepreneurship programme delivered by a KIC. The Community represents a network of over 5 000 members. (21) As defined in point (13) of Article 2 of Regulation (EU) 2021/819. (22) As defined in point (15) of Article 2 of Regulation (EU) 2021/819. (23) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, p. 1). (24) Regulation (EU) 2021/818 of the European Parliament and of the Council of 20 May 2021 establishing the Creative Europe Programme (2021 to 2027) and repealing Regulation (EU) No 1295/2013 (see page 34 of this Official Journal). (25) Regulation (EU) 2021/690 of the European Parliament and of the Council of 28 April 2021 establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014 (OJ L 153, 3.5.2021, p. 1). (26) CCSI relate to all sectors and industries whose activities are based on cultural values, cultural diversity and individual and/or collective artistic and other creative expressions, whether those activities are market or non-market oriented, whatever the type of structure that carries them out, and irrespective of how that structure is financed. Those activities include the development of skills and talent with the potential to generate innovation, the creation of wealth and jobs through the production of social and economic value, including from intellectual property management. Those activities relate also to the development, the production, the creation, the dissemination and the preservation of goods and services which embody cultural, artistic or other creative expressions, as well as related functions such as education and management. The cultural and creative sectors include, inter alia, architecture, archives, the arts, libraries and museums, artistic crafts, audiovisual (including film, television, software, video games, multimedia and recorded music), tangible and intangible cultural heritage, design, creativity-driven high-end industries and fashion, festivals, music, literature, performing arts (including theatre and dance), books and publishing (newspapers and magazines), radio and visual arts, and advertising. (27) Cultural and creative studies in European universities are mostly focused on the \u2018creative part\u2019 and their graduates are not always ready to enter the modern labour market as they lack cross-sectoral (entrepreneurial, digital and financial management) skills. With regard to HEIs, the Union is trailing behind the United States of America in communication and media studies (while Union universities are performing better in more traditional disciplines such as art and design or performing arts). (28) Impact assessment accompanying the communication of the Commission of 17 September 2020 on Stepping up Europe\u2019s 2030 climate ambition. Investing in a climate-neutral future for the benefit of our people. (29) Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1). (30) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (31) Directive 2014/89/EU of the European Parliament and of the Council of 23 July 2014 establishing a framework for maritime spatial planning (OJ L 257, 28.8.2014, p. 135). (32) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).", "summary": "European Institute of Innovation and Technology (EIT) European Institute of Innovation and Technology (EIT) SUMMARY OF: Regulation (EU) 2021/819 on the European Institute of Innovation and Technology Decision (EU) 2021/820 on the Strategic Innovation Agenda of the European Institute of Innovation and Technology (EIT) 2021-2027 WHAT IS THE AIM OF THE REGULATION AND DECISION? The regulation establishes the European Institute of Innovation and Technology (EIT), originally created in 2008. The decision formally adopts the EIT\u2019s Strategic Innovation Agenda (SIA) for the period from 2021 to 2027. They set the agenda for the EIT from 2021 to 2027 and aim to improve aspects of the Knowledge and Innovation Communities (KICs), including their: funding model openness and transparency integration in local innovation ecosystems. KEY POINTS EIT mission The regulation sets out EIT\u2019s priorities and financial needs for 2021-2027 in an SIA in line with Horizon Europe \u2014 the Framework Programme for Research and Innovation, set up by Regulation (EU) 2021/695 (see summary). The EIT\u2019s mission is to contribute to sustainable economic growth and competitiveness by improving the capacity of the European Union (EU) and EU Member States to innovate and tackle major challenges faced by society. The key feature of the EIT is integrating the knowledge triangle (education, research and innovation). The key features of the agreed SIA are the following: KICs must be more open, inclusive and transparent; improving the scope of support for entrepreneurial and innovation capacity in higher education; extending the eligibility and the budget for activities under the Regional Innovation Scheme (RIS) to countries with more modest innovation scores; a simplified performance-based funding model for KICs; a continuous monitoring and evaluation system for KICs, including closer monitoring of their openness; clarifying the EIT\u2019s relations with KICs after the end of the framework partnership agreement; the launch of new KICs in the cultural and creative sectors in 2022 or 2023in industries; water, marine and maritime sectors; and ecosystems in 2026. The EIT is designed to carry out its activities independently of national authorities and external pressures. KIC roles and responsibilities The KICs carry out at least the following: innovation activities and investments including facilitating the creation of innovative start-ups and the development of innovative businesses fully integrating higher education and research; innovation-driven research in areas of key economic, environmental and societal interest and drawing on EU and national research; education and training activities, in particular at master\u2019s and doctoral level, and professional training courses, in areas with the potential to meet future European socio-economic and socio-ecological needs; outreach activities and the dissemination of best practices in innovation with a focus on the development of cooperation between higher education, research and business, including the service and financial sectors, and, where relevant, public and third-sector organisations; RIS activities in countries with more modest innovation scores, fully integrated in the KICs\u2019 multiannual strategy to strengthen innovation capacity and to develop sustainable innovation ecosystems; mobilise funds from public and private sources, in particular aiming to raise an increasing proportion from private sources and from income generated by their own activities; information on demand on research and innovation outputs and results, and related intellectual property rights. EIT budget The EU contributes \u20ac2,726,000,000 from Horizon Europe funds at 2021 prices, plus an additional \u20ac210,000,000 at 2018 prices, for the period 2021-2027. The EIT may receive additional finance from other EU programmes. EIT monitoring and evaluation The European Commission evaluates the EIT and the KICs\u2019 performance with the assistance of independent external experts and taking into account the views of stakeholders. WHEN DOES THE REGULATION APPLY? Regulation (EU) 2021/819 has applied since 28 May 2021 except for a number of articles which have applied since 1 January 2021. Regulation (EU) 2021/819 revised and replaced Regulation (EC) No 294/2008 and its subsequent amendments. Decision (EU) 2021/820 has applied since 1 January 2021. BACKGROUND See also: Making innovation happen (EIT) EIT Strategy 2021-2027 (EIT) Horizon Europe (European Commission). MAIN DOCUMENTS Regulation (EU) 2021/819 of the European Parliament and of the Council of 20 May 2021 on the European Institute of Innovation and Technology (recast) (OJ L 189, 28.5.2021, pp. 61-90) Decision (EU) 2021/820 of the European Parliament and of the Council of 20 May 2021 on the Strategic Innovation Agenda of the European Institute of Innovation and Technology (EIT) 2021-2027: Boosting the Innovation Talent and Capacity of Europe and repealing Decision No 1312/2013/EU (OJ L 189, 28.5.2021, pp. 91-118) RELATED DOCUMENTS Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe \u2014 the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1-68) last update 19.07.2021"}
{"article": "20.3.2014 EN Official Journal of the European Union L 84/14 REGULATION (EU) No 251/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) and Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Council Regulation (EEC) No 1601/91 (3) and Commission Regulation (EC) No 122/94 (4) have proved successful in regulating aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails (\u2018aromatised wine products\u2019). However, in the light of technologic innovation, market developments and evolving consumer expectations it is necessary to update the rules applicable to the definition, description, presentation, labelling and protection of geographical indications of certain aromatised wine products, while taking into account traditional production methods. (2) Further amendments are needed as a consequence of the entry into force of the Lisbon Treaty, in order to align the powers conferred upon the Commission pursuant to Regulation (EEC) No 1601/91 to Articles 290 and 291 of the Treaty on the Functioning of the European Union (TFEU). In view of the scope of those amendments, it is appropriate to repeal Regulation (EEC) No 1601/91 and to replace it with this Regulation. Regulation (EC) No 122/94 introduced rules on flavouring and addition of alcohol applicable to some aromatised wine products, and in order to ensure clarity, those rules should be incorporated into this Regulation. (3) Regulation (EU) No 1169/2011 of the European Parliament and of the Council (5) applies to the presentation and labelling of aromatised wine products, save as otherwise provided for in this Regulation. (4) Aromatised wine products are important for consumers, producers and the agricultural sector in the Union. The measures applicable to aromatised wine products should contribute to the attainment of a high level of consumer protection, the prevention of deceptive practices and the attainment of market transparency and fair competition. By doing so, the measures will safeguard the reputation that the Union\u2019s aromatised wine products have achieved in the internal market and on the world market by continuing to take into account the traditional practices used in the production of aromatised wine products as well as increased demand for consumer protection and information. Technological innovation should also be taken into account in respect of the products for which such innovation serves to improve quality, without affecting the traditional character of the aromatised wine products concerned. (5) The production of aromatised wine products constitutes a major outlet for the agricultural sector of the Union, which should be emphasised by the regulatory framework. (6) In the interest of consumers, this Regulation should apply to all aromatised wine products placed on the market in the Union, whether produced in the Member States or in third countries. In order to maintain and improve the reputation of the Union\u2019s aromatised wine products on the world market, the rules provided for in this Regulation should also apply to aromatised wine products produced in the Union for export. (7) To ensure clarity and transparency in Union law governing aromatised wine products, it is necessary to clearly define the products covered by that law, the criteria for the production, description, presentation and labelling of aromatised wine products and in particular, the sales denomination. Specific rules on the voluntary indication of the provenance supplementing those laid down in Regulation (EU) No 1169/2011 should also be laid down. By laying down such rules, all stages in the production chain are regulated and consumers are protected and properly informed. (8) The definitions of aromatised wine products should continue to respect traditional quality practices but should be updated and improved in the light of technological developments. (9) Aromatised wine products should be produced in accordance with certain rules and restrictions, which guarantee that consumer expectations as regards quality and production methods are met. In order to meet the international standards in this field, the production methods should be established and the Commission should as a general rule take into account the standards recommended and published by the International Organisation of Vine and Wine (OIV). (10) Regulation (EC) No 1333/2008 of the European Parliament and of the Council (6) and Regulation (EC) No 1334/2008 of the European Parliament and of the Council (7) should apply to aromatised wine products. (11) Moreover, the ethyl alcohol used for the production of aromatised wine products should be exclusively of agricultural origin, so as to meet consumer expectations and conform to traditional quality practices. This will also ensure an outlet for basic agricultural products. (12) Given the importance and complexity of the aromatised wine products sector, it is appropriate to lay down specific rules on the description and presentation of aromatised wine products supplementing the labelling provisions laid down in Regulation (EU) No 1169/2011. Those specific rules should also prevent the misuse of sales denominations of aromatised wine products in the case of products which do not meet the requirements set out in this Regulation. (13) With a view to facilitating consumers\u2019 understanding, it should be possible to supplement the sales denominations laid down in this Regulation with the customary name of the product within the meaning of Regulation (EU) No 1169/2011. (14) Council Regulation (EC) No 834/2007 (8) applies, inter alia, to processed agricultural products for use as food, which includes aromatised wine products. Accordingly, aromatised wine products which meet the requirements laid down in that Regulation and the acts adopted pursuant to it may be placed on the market as organic aromatised wine products. (15) In applying a quality policy and in order to allow a high level of quality of aromatised wine products with a geographical indication, Member States should be allowed to adopt stricter rules than those laid down in this Regulation on the production, description, presentation and labelling of aromatised wine products with a geographical indication that are produced in their own territory, in so far as such rules are compatible with Union law. (16) Given that Regulation (EC) No 110/2008 of the European Parliament and of the Council (9), Regulation (EU) No 1151/2012 of the European Parliament and of the Council (10), and the provisions on geographical indications in Regulation (EU) No 1308/2013 of the European Parliament and of the Council (11) do not apply to aromatised wine products, specific rules on protection of geographical indications for aromatised wine products should be laid down. Geographical indications should be used to identify aromatised wine products as originating in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of the aromatised wine product is essentially attributable to its geographical origin and such geographical indications should be registered by the Commission. (17) A procedure for the registration, compliance, alteration and possible cancellation of third country and Union geographical indications should be laid down in this Regulation. (18) Member State authorities should be responsible for ensuring compliance with this Regulation, and arrangements should be made for the Commission to be able to monitor and verify such compliance. (19) In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the TFEU should be delegated to the Commission in respect of the establishment of production processes for obtaining aromatised wine products; criteria for the demarcation of geographical areas and rules, restrictions and derogations related to production in such areas; the conditions under which a product specification may include additional requirements; the determination of the cases in which a single producer may apply for the protection of a geographical indication and the restrictions governing the type of applicant that may apply for such protection; the establishment of the conditions to be complied with in respect of an application for the protection of a geographical indication, scrutiny by the Commission, the objection procedure and procedures for amendment and cancellation of geographical indications; the establishment of the conditions applicable to trans-border applications; the setting of the date for the submission of an application or a request, the date from which the protection applies and the date on which an amendment to a protection applies; the establishment of the conditions relating to amendments to product specifications, including the conditions when an amendment is considered minor and the conditions relating to the applications for, and approval of, amendments, which do not involve any change to the single document; the restrictions regarding the protected name; the nature and type of information to be notified in the exchange of information between Member States and the Commission, the methods of notification, the rules related to the access rights to information or information systems made available and the modalities of publication of the information. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (20) In order to ensure uniform conditions for the implementation of this Regulation with regard to the methods of analysis for determining the composition of aromatised wine products; decisions on conferring protection on geographical indications and on rejecting applications for such protection; decisions on cancelling the protection of geographical indications and of existing geographical designations; decisions on approval of application for amendments in the case of minor amendments to the product specifications; the information to be provided in the product specification with regard to the definition of geographical indication; the means of making decisions on protection or rejection of geographical indications available to the public; relating to the submission of trans-border applications; checks and verifications to be carried out by Member States; the procedure, including admissibility, for the examination of applications for protection or for the approval of an amendment of a geographical indication, and the procedure, including admissibility, for requests for objection, cancellation or conversion and the submission of information relating to existing geographical designations; administrative and physical checks to be carried out by Member States; and rules on providing the information necessary for the application of the provision concerning the exchange of information between Member States and the Commission, the arrangements for the management of the information to be notified, the content, form, timing, frequency and deadlines of the notifications and arrangements for transmitting or making information and documents available to the Member States, the competent authorities in third countries, or the public; implementing power should be conferred on the Commission. Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (12). (21) The Commission should, by means of implementing acts and, given their special nature, acting without applying Regulation (EU) No 182/2011, publish the single document in the Official Journal of the European Union, decide whether to reject an application for protection of a geographical indication on grounds of inadmissibility and establish and maintain a register of geographical indications protected under this Regulation, including the listing of existing geographical designations in that register or their removal from the register. (22) The transition from the rules provided for in Regulation (EEC) No 1601/91 to those laid down in this Regulation could give rise to difficulties which are not dealt with in this Regulation. For that purpose, the power to adopt the necessary transitional measures should be delegated to the Commission. (23) Sufficient time and appropriate arrangements should be allowed to facilitate a smooth transition from the rules provided for in Regulation (EEC) No 1601/91 to the rules laid down in this Regulation. In any event the marketing of existing stocks should be allowed after the application of this Regulation, until those stocks are exhausted. (24) Since the objectives of this Regulation, namely the establishment of the rules on the definition, description, presentation and labelling of aromatised wine products and rules on the protection of geographical indications of aromatised wine products, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER I SCOPE AND DEFINITIONS Article 1 Subject matter and scope 1. This Regulation lays down rules on the definition, description, presentation and labelling of aromatised wine products as well as on the protection of geographical indications of aromatised wine products. 2. Regulation (EU) No 1169/2011 shall apply to the presentation and labelling of aromatised wine products, save as otherwise provided for in this Regulation. 3. This Regulation shall apply to all aromatised wine products placed on the market in the Union whether produced in the Member States or in third countries, as well as to those produced in the Union for export. Article 2 Definitions For the purpose of this Regulation, the following definitions apply: (1) \u2018sales denomination\u2019 means the name of any of the aromatised wine products laid down in this Regulation; (2) \u2018description\u2019 means the list of the specific characteristics of an aromatised wine product; (3) \u2018geographical indication\u2019 means an indication which identifies an aromatised wine product as originating in a region, a specific place, or a country, where a given quality, reputation or other characteristics of that product is essentially attributable to its geographical origin. CHAPTER II DEFINITION, DESCRIPTION, PRESENTATION AND LABELLING OF AROMATISED WINE PRODUCTS Article 3 Definition and classification of aromatised wine products 1. Aromatised wine products are products obtained from products of the wine sector as referred to in Regulation (EU) No 1308/2013 that have been flavoured. They are classified into the following categories: (a) aromatised wines; (b) aromatised wine-based drinks; (c) aromatised wine-product cocktails. 2. Aromatised wine is a drink: (a) obtained from one or more of the grapevine products defined in point 5 of Part IV of Annex II and in points 1 and 3 to 9 of Part II of Annex VII to Regulation (EU) No 1308/2013, with the exception of \u2018Retsina\u2019 wine; (b) in which the grapevine products referred to in point (a) represent at least 75 % of the total volume; (c) to which alcohol may have been added; (d) to which colours may have been added; (e) to which grape must, partially fermented grape must or both may have been added; (f) which may have been sweetened; (g) which has an actual alcoholic strength by volume of not less than 14,5 % vol. and less than 22 % vol. and a total alcoholic strength by volume of not less than 17,5 % vol. 3. Aromatised wine-based drink is a drink: (a) obtained from one or more of the grapevine products defined in points 1, 2 and 4 to 9 of Part II of Annex VII to Regulation (EU) No 1308/2013, with the exception of wines produced with the addition of alcohol and \u2018Retsina\u2019 wine; (b) in which the grapevine products referred to in point (a) represent at least 50 % of the total volume; (c) to which no alcohol has been added, except where Annex II provides otherwise; (d) to which colours may have been added; (e) to which grape must, partially fermented grape must or both may have been added; (f) which may have been sweetened; (g) which has an actual alcoholic strength by volume of not less than 4,5 % vol. and less than 14,5 % vol. 4. Aromatised wine-product cocktail is a drink: (a) obtained from one or more of the grapevine products defined in points 1, 2 and 4 to 11 of Part II of Annex VII to Regulation (EU) No 1308/2013, with the exception of wines produced with the addition of alcohol and \u2018Retsina\u2019 wine; (b) in which the grapevine products referred to in point (a) represent at least 50 % of the total volume; (c) to which no alcohol has been added; (d) to which colours may have been added; (e) which may have been sweetened; (f) which has an actual alcoholic strength by volume of more than 1,2 % vol. and less than 10 % vol. Article 4 Production processes and methods of analysis for aromatised wine products 1. Aromatised wine products shall be produced in accordance with the requirements, restrictions and descriptions laid down in Annexes I and II. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 33 concerning the establishment of authorised production processes for obtaining aromatised wine products, taking into account consumers\u2019 expectations. In establishing the authorised production processes referred to in the first subparagraph, the Commission shall take into account the production processes recommended and published by the OIV. 3. The Commission shall, where necessary, adopt, by means of implementing acts, methods of analysis for determining the composition of aromatised wine products. Those methods shall be based on any relevant methods recommended and published by the OIV, unless they would be ineffective or inappropriate in view of the objective pursued. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Pending the adoption of such methods by the Commission, the methods to be used shall be those allowed by the Member State concerned. 4. The oenological practices and restrictions laid down in accordance with Articles 74, 75(4) and 80 of Regulation (EU) No 1308/2013 shall apply to the grapevine products used in the production of aromatised wine products. Article 5 Sales denominations 1. The sales denominations set out in Annex II shall be used for any aromatised wine product placed on the market in the Union, provided that it complies with the requirements for the corresponding sales denomination laid down in that Annex. Sales denominations may be supplemented by a customary name as defined in Article 2(2)(o) of Regulation (EU) No 1169/2011. 2. Where aromatised wine products comply with the requirements of more than one sales denomination, the use of only one of those sales denominations is authorised, except where Annex II provides otherwise. 3. An alcoholic beverage not fulfilling the requirements laid down in this Regulation shall not be described, presented or labelled by associating words or phrases such as \u2018like\u2019, \u2018type\u2019, \u2018style\u2019, \u2018made\u2019, \u2018flavour\u2019 or any other term similar to any of the sales denominations. 4. Sales denominations may be supplemented or replaced by a geographical indication protected under this Regulation. 5. Without prejudice to Article 26, sales denominations shall not be supplemented by protected designations of origin or protected geographical indications allowed for wine products. Article 6 Additional particulars to the sales denominations 1. The sales denominations referred to in Article 5 may also be supplemented by the following particulars concerning the sugar content of the aromatised wine product: (a) \u2018extra-dry\u2019: in the case of products with a sugar content of less than 30 grams per litre and, for the category of aromatised wines and by way of derogation from Article 3(2)(g), a minimum total alcoholic strength by volume of 15 % vol.; (b) \u2018dry\u2019: in the case of products with a sugar content of less than 50 grams per litre and, for the category of aromatised wines and by way of derogation from Article 3(2)(g), a minimum total alcoholic strength by volume of 16 % vol.; (c) \u2018semi-dry\u2019: in the case of products with a sugar content of between 50 and less than 90 grams per litre; (d) \u2018semi-sweet\u2019: in the case of products with a sugar content of between 90 and less than 130 grams per litre; (e) \u2018sweet\u2019: in the case of products with a sugar content of 130 grams per litre or more. The sugar content indicated in points (a) to (e) of the first subparagraph is expressed as invert sugar. The particulars \u2018semi-sweet\u2019 and \u2018sweet\u2019 may be accompanied by an indication of the sugar content, expressed in grams of invert sugar per litre. 2. Where the sales denomination is supplemented by or includes the particular \u2018sparkling\u2019, the quantity of sparkling wine used shall be not less than 95 %. 3. Sales denominations may also be supplemented by a reference to the main flavouring used. Article 7 Indication of provenance Where the provenance of aromatised wine products is indicated, it shall correspond to the place where the aromatised wine product is produced. The provenance shall be indicated with the words \u2018produced in (\u2026)\u2019, or expressed in equivalent terms, supplemented by the name of the corresponding Member State or third country. Article 8 Use of language in the presentation and labelling of aromatised wine products 1. The sales denominations set out in italics in Annex II shall not be translated on the label or in the presentation of aromatised wine products. Additional particulars provided for in this Regulation shall, where expressed in words, appear in at least one of the official languages of the Union. 2. The name of the geographical indication protected under this Regulation shall appear on the label in the language or languages in which it is registered, even where the geographical indication replaces the sales denomination in accordance with Article 5(4). Where the name of a geographical indication protected under this Regulation is written in a non-Latin alphabet, it may also appear in one or more of the official languages of the Union. Article 9 Stricter rules decided by Member States In applying a quality policy for aromatised wine products with geographical indications protected under this Regulation which are produced on their own territory or for the establishment of new geographical indications, Member States may lay down rules on production and description which are stricter than those referred to in Article 4 and in Annexes I and II in so far as they are compatible with Union law. CHAPTER III GEOGRAPHICAL INDICATIONS Article 10 Content of applications for protection 1. Applications for the protection of names as geographical indications shall include a technical file containing: (a) the name to be protected; (b) the name and address of the applicant; (c) a product specification as referred to in paragraph 2; and (d) a single document summarising the product specification referred to in paragraph 2. 2. To be eligible for a geographical indication protected under this Regulation a product shall comply with the corresponding product specification which shall include at least: (a) the name to be protected; (b) a description of the product, in particular its principal analytical characteristics as well as an indication of its organoleptic characteristics; (c) where applicable, the particular production processes and specifications as well as the relevant restrictions on making the product; (d) the demarcation of the geographical area concerned; (e) the details bearing out the link referred to in point (3) of Article 2; (f) the applicable requirements laid down in Union or national law or, where provided for by Member States, by an organisation which manages the protected geographical indication, having regard to the fact that such requirements shall be objective, and non-discriminatory and compatible with Union law; (g) an indication of the main raw material from which the aromatised wine product is obtained; (h) the name and address of the authorities or bodies verifying compliance with the provisions of the product specification and their specific tasks. Article 11 Application for protection relating to a geographical area in a third country 1. Where the application for protection concerns a geographical area in a third country, it shall contain in addition to the elements provided for in Article 10, proof that the name in question is protected in its country of origin. 2. The application for protection shall be sent to the Commission, either directly by the applicant or via the authorities of the third country concerned. 3. The application for protection shall be filed in one of the official languages of the Union or accompanied by a certified translation into one of those languages. Article 12 Applicants 1. Any interested group of producers, or in exceptional cases a single producer, may lodge an application for protection of a geographical indication. Other interested parties may participate in the application for protection. 2. Producers may lodge an application for protection only for aromatised wine products which they produce. 3. In the case of a name designating a trans-border geographical area, a joint application for protection may be lodged. Article 13 Preliminary national procedure 1. Applications for protection of a geographical indication of aromatised wine products originating in the Union shall be subject to a preliminary national procedure in accordance with paragraphs 2 to 7 of this Article. 2. The application for protection shall be filed with the Member State in whose territory the geographical indication originates. 3. The Member State shall examine the application for protection in order to verify whether it meets the conditions set out in this Chapter. The Member State shall, by means of a national procedure, ensure the adequate publication of the application for protection and shall provide for a period of at least two months from the date of publication within which any natural or legal person with a legitimate interest and resident or established on its territory may object to the proposed protection by lodging a duly substantiated statement with the Member State. 4. If the Member State considers that the geographical indication does not meet the relevant requirements or is incompatible with Union law in general, it shall reject the application. 5. If the Member State considers that the relevant requirements are met, it shall: (a) publish the single document and the product specification at least on the internet; and (b) forward to the Commission an application for protection containing the following information: (i) the name and address of the applicant; (ii) the product specification referred in Article 10(2); (iii) the single document referred to in Article 10(1)(d); (iv) a declaration by the Member State that it considers that the application lodged by the applicant meets the conditions required; and (v) the reference to the publication, as referred to in point (a). The information referred to in point (b) of the first subparagraph shall be forwarded in one of the official languages of the Union or accompanied by a certified translation into one of those languages. 6. Member States shall adopt the laws, regulations or administrative provisions necessary to comply with this Article by 28 March 2015. 7. Where a Member State has no national legislation concerning the protection of geographical indications, it may, on a transitional basis only, grant protection to the name in accordance with the terms of this Chapter at national level. Such protection shall take effect from the date the application is lodged with the Commission and shall cease on the date on which a decision on registration or refusal under this Chapter is taken. Article 14 Scrutiny by the Commission 1. The Commission shall make the date of submission of the application for protection public. 2. The Commission shall examine whether the applications for protection referred to in Article 13(5) meet the conditions laid down in this Chapter. 3. Where the Commission considers that the conditions laid down in this Chapter are met, it shall, by means of implementing acts adopted without applying the procedure referred to in Article 34(2), publish in the Official Journal of the European Union the single document referred to in Article 10(1)(d) and the reference to the publication of the product specification referred to in Article 13(5)(a). 4. Where the Commission considers that the conditions laid down in this Chapter are not met, it shall, by means of implementing acts, decide to reject the application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Article 15 Objection procedure Within two months from the date of publication provided for in Article 14(3), any Member State or third country, or any natural or legal person with a legitimate interest, resident or established in a Member State other than that applying for the protection or in a third country, may object to the proposed protection by lodging with the Commission a duly substantiated statement relating to the conditions of eligibility as laid down in this Chapter. In the case of natural or legal persons resident or established in a third country, such statement shall be lodged, either directly or via the authorities of the third country concerned, within the time limit of two months referred to in the first paragraph. Article 16 Decision on protection On the basis of the information available to the Commission upon the completion of the objection procedure referred to in Article 15, the Commission shall, by means of implementing acts, either confer protection on the geographical indication which meets the conditions laid down in this Chapter and is compatible with Union law, or reject the application where those conditions are not met. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Article 17 Homonyms 1. A name, for which an application for protection is lodged, and which is wholly or partially homonymous with that of a name already registered under this Regulation, shall be registered with due regard for local and traditional usage and for any risk of confusion. 2. A homonymous name which misleads the consumer into believing that products come from another territory shall not be registered even if the name is accurate as far as the actual territory, region or place of origin of the products in question is concerned. 3. The use of a registered homonymous name shall be subject to there being a sufficient distinction in practice between the homonym registered subsequently and the name already on the register, having regard to the need to treat the producers concerned in an equitable manner and not to mislead the consumer. Article 18 Grounds for refusal of protection 1. Names that have become generic shall not be protected as a geographical indication. For the purposes of this Chapter, a \u2018name that has become generic\u2019 means the name of an aromatised wine product which, although relating to the place or the region where this product was originally produced or placed on the market, has become the common name of an aromatised wine product in the Union. To establish whether or not a name has become generic, account shall be taken of all relevant factors, in particular: (a) the existing situation in the Union, notably in areas of consumption; (b) the relevant Union or national law. 2. A name shall not be protected as a geographical indication where, in the light of a trademark\u2019s reputation and renown, protection is liable to mislead the consumer as to the true identity of the aromatised wine product. Article 19 Relationship with trademarks 1. Where a geographical indication is protected under this Regulation, the registration of a trademark the use of which falls under Article 20(2) and relating to an aromatised wine product shall be refused if the application for registration of the trademark is submitted after the date of submission of the application for protection of the geographical indication to the Commission and the geographical indication is subsequently protected. Trademarks registered in breach of the first subparagraph shall be invalidated. 2. Without prejudice to Article 17(2), a trademark the use of which falls under Article 20(2), which has been applied for, registered or established by use, if that possibility is provided for by the legislation concerned, in the territory of the Union before the date on which the application for protection of the geographical indication is submitted to the Commission, may continue to be used and renewed notwithstanding the protection of a geographical indication, provided that no grounds for the trademark\u2019s invalidity or revocation exist as specified by the Directive 2008/95/EC of the European Parliament of the Council (13) or by Council Regulation (EC) No 207/2009 (14). In such cases the use of the geographical indication shall be permitted alongside the relevant trademarks. Article 20 Protection 1. Geographical indications protected under this Regulation may be used by any operator marketing an aromatised wine product which has been produced in conformity with the corresponding product specification. 2. Geographical indications protected under this Regulation and the aromatised wine products using those protected names in conformity with the product specification shall be protected against: (a) any direct or indirect commercial use of a protected name: (i) by comparable products not complying with the product specification of the protected name; or (ii) in so far as such use exploits the reputation of a geographical indication; (b) any misuse, imitation or evocation, even if the true origin of the product or service is indicated or if the protected name is translated, transcribed or transliterated or accompanied by an expression such as \u2018style\u2019, \u2018type\u2019, \u2018method\u2019, \u2018as produced in\u2019, \u2018imitation\u2019, \u2018flavour\u2019, \u2018like\u2019 or similar; (c) any other false or misleading indication as to the provenance, origin, nature or essential qualities of the product, on the inner or outer packaging, advertising material or documents relating to the wine product concerned, and the packing of the product in a container liable to convey a false impression as to its origin; (d) any other practice liable to mislead the consumer as to the true origin of the product. 3. Geographical indications protected under this Regulation shall not become generic in the Union within the meaning of Article 18(1). 4. Member States shall take the appropriate administrative and judicial measures to prevent or to stop unlawful use of geographical indications protected under this Regulation as referred to in paragraph 2. Article 21 Register The Commission shall, by means of implementing acts adopted without applying the procedure referred to in Article 34(2), establish and maintain an electronic register of geographical indications protected under this Regulation for aromatised wine products which shall be publicly accessible. Geographical indications pertaining to products of third countries that are protected in the Union pursuant to an international agreement to which the Union is a contracting party may be entered in the register referred to in the first paragraph as geographical indications protected under this Regulation. Article 22 Designation of competent authority 1. Member States shall designate the competent authority or authorities responsible for checks in respect of the obligations established by this Chapter in accordance with the criteria laid down in Article 4 of Regulation (EC) No 882/2004 of the European Parliament and of the Council (15). 2. Member States shall ensure that any operator complying with this Chapter is entitled to be covered by a system of checks. 3. Member States shall inform the Commission of the competent authority or authorities referred to in paragraph 1. The Commission shall make their names and addresses public and update them periodically. Article 23 Verification of compliance with specifications 1. In respect of geographical indications protected under this Regulation relating to a geographical area within the Union, annual verification of compliance with the product specification, during the production and during or after conditioning of the aromatised wine product, shall be ensured by: (a) the competent authority or authorities referred to in Article 22; or (b) one or more control bodies responsible for the verification within the meaning of point 5 of the second paragraph of Article 2 of Regulation (EC) No 882/2004 operating as a product certification body in accordance with the requirements laid down in Article 5 of that Regulation. The costs of such verification shall be borne by the operators subject to it. 2. In respect of geographical indications protected under this Regulation relating to a geographical area in a third country, annual verification of compliance with the product specification, during the production and during or after conditioning of the aromatised wine product, shall be ensured by: (a) one or more public authorities designated by the third country; or (b) one or more certification bodies. 3. The bodies referred to in point (b) of paragraph 1 and point (b) of paragraph 2 shall comply with, and be accredited in accordance with, the Standard EN ISO/IEC 17065:2012 (Conformity assessments \u2014 Requirements for bodies certifying products processes and services). 4. Where the authority or authorities referred to in point (a) of paragraph 1 and point (a) of paragraph 2 verify compliance with the product specification, they shall offer adequate guarantees of objectivity and impartiality, and have at their disposal the qualified staff and resources needed to carry out their tasks. Article 24 Amendments to product specifications 1. An applicant satisfying the conditions of Article 12 may apply for approval of an amendment to the product specification of a geographical indication protected under this Regulation, in particular in order to take account of developments in scientific and technical knowledge or to redefine the geographical area referred to in point (d) of Article 10(2). Applications shall describe and give reasons for the amendments requested. 2. Where the proposed amendment involves one or more changes to the single document referred to in point (d) of Article 10(1), Articles 13 to 16 shall apply mutatis mutandis to the application for amendment. However, if the proposed amendment is only minor, the Commission shall, by means of implementing acts, decide whether to approve the application without following the procedure laid down in Article 14(2) and Article 15 and in the case of approval, the Commission shall proceed to the publication of the elements referred to in Article 14(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Article 25 Cancellation The Commission may, on its own initiative or at the duly substantiated request of a Member State, of a third country or of a natural or legal person having a legitimate interest, decide, by means of implementing acts, to cancel the protection of a geographical indication if compliance with the corresponding product specification is no longer ensured. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Articles 13 to 16 shall apply mutatis mutandis. Article 26 Existing geographical designations 1. Geographical designations of aromatised wine products listed in Annex II to Regulation (EEC) No 1601/91 and any geographical designation submitted to a Member State and approved by that Member State before 27 March 2014, shall automatically be protected as geographical indications under this Regulation. The Commission shall, by means of implementing acts adopted without applying the procedure referred to in Article 34(2) of this Regulation, list them in the register provided for in Article 21 of this Regulation. 2. Member States shall, in respect of existing geographical designations referred to in paragraph 1, transmit to the Commission: (a) the technical files as provided for in Article 10(1); (b) the national decisions of approval. 3. Existing geographical designations referred to in paragraph 1, for which the information referred to in paragraph 2 is not submitted by 28 March 2017, shall lose protection under this Regulation. The Commission shall, by means of implementing acts adopted without applying the procedure referred to in Article 34(2), take the corresponding formal step of removing such names from the register provided for in Article 21. 4. Article 25 shall not apply in respect of existing geographical designations referred to in paragraph 1 of this Article. Until 28 March 2018 the Commission may, by means of implementing acts, on its own initiative, decide to cancel the protection of existing geographical designations referred to in paragraph 1 of this Article if they do not comply with point (3) of Article 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Article 27 Fees Member States may charge a fee to cover their costs, including those incurred in examining applications for protection, statements of objections, applications for amendments and requests for cancellations under this Chapter. Article 28 Delegated powers 1. In order to take account of the specific characteristics of the production in the demarcated geographical area, the Commission shall be empowered to adopt delegated acts in accordance with Article 33 concerning: (a) criteria for the demarcation of the geographical area; and (b) rules, restrictions and derogations related to the production in the demarcated geographical area. 2. In order to ensure product quality and traceability, the Commission shall be empowered to adopt delegated acts in accordance with Article 33 in order to establish the conditions under which product specifications may include additional requirements to those referred to in Article 10(2)(f). 3. In order to ensure the rights or legitimate interests of producers or operators, the Commission shall be empowered to adopt delegated acts in accordance with Article 33 in order to: (a) determine the cases in which a single producer may apply for the protection of a geographical indication; (b) determine the restrictions governing the type of applicant that may apply for the protection of a geographical indication; (c) establish the conditions to be followed in respect of an application for the protection of a geographical indication, scrutiny by the Commission, the objection procedure, and procedures for amendment and cancellation of geographical indications; (d) establish the conditions applicable to transborder applications; (e) set the date of submission of an application or a request; (f) set the date from which protection shall run; (g) establish the conditions under which an amendment is to be considered as minor as referred to in Article 24(2); (h) set the date on which an amendment shall enter into force; (i) establish the conditions relating to the applications for, and approval of, amendments to the product specification of a geographical indication protected under this Regulation, where such amendments do not involve any change to the single document referred to in point (d) of Article 10(1). 4. In order to ensure adequate protection, the Commission shall be empowered to adopt delegated acts in accordance with Article 33 concerning the restrictions regarding the protected name. Article 29 Implementing powers 1. The Commission may, by means of implementing acts, adopt all necessary measures related to this Chapter regarding: (a) the information to be provided in the product specification with regard to the link referred to in point (3) of Article 2 between the geographical area and the final product; (b) the means of making the decisions on protection or rejection referred to in Article 16 available to the public; (c) the submission of trans-border applications; (d) checks and verification to be carried out by the Member States, including testing. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). 2. The Commission may, by means of implementing acts, adopt all necessary measures related to this Chapter as regards the procedure, including admissibility, for the examination of applications for protection or for the approval of an amendment of a geographical indication, as well as the procedure, including admissibility, for requests for objection, cancellation, or conversion, and the submission of information relating to existing protected geographical designations, in particular with respect to: (a) models for documents and the transmission format; (b) time limits; (c) the details of the facts, evidence and supporting documents to be submitted in support of the application or request. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Article 30 Inadmissible application or request Where an application or a request submitted under this Chapter is deemed inadmissible, the Commission shall, by means of implementing acts adopted without applying the procedure referred to in Article 34(2), decide to reject it as inadmissible. CHAPTER IV GENERAL, TRANSITIONAL AND FINAL PROVISIONS Article 31 Checks and verification of aromatised wine products 1. Member States shall be responsible for the checks of aromatised wine products. They shall take the measures necessary to ensure compliance with the provisions of this Regulation and in particular they shall designate the competent authority or authorities responsible for checks in respect of the obligations established by this Regulation in accordance with Regulation (EC) No 882/2004. 2. The Commission shall, when necessary, by means of implementing acts, adopt the rules concerning administrative and physical checks to be conducted by the Member States with regard to the respect of obligations resulting from the application of this Regulation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Article 32 Exchange of information 1. Member States and the Commission shall notify each other of any information necessary for the application of this Regulation and for complying with the international obligations concerning the aromatised wine products. That information may, where appropriate, be transmitted or made available to the competent authorities of third countries and may be made public. 2. In order to make the notifications referred to in paragraph 1 fast, efficient, accurate, and cost effective, the Commission shall be empowered to adopt delegated acts in accordance with Article 33 to lay down: (a) the nature and type of the information to be notified; (b) the methods of notification; (c) the rules related to the access rights to the information or information systems made available; (d) the conditions and means of publication of the information. 3. The Commission shall, by means of implementing acts, adopt: (a) rules on providing the information necessary for the application of this Article; (b) arrangements for the management of the information to be notified, as well as rules on content, form, timing, frequency and deadlines of the notifications; (c) arrangements for transmitting or making information and documents available to the Member States, the competent authorities in third countries, or the public. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Article 33 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 4(2), 28, 32(2) and 36(1) shall be conferred on the Commission for a period of five years from 27 March 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 4(2), 28, 32(2) and 36(1) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 4(2), 28, 32(2) and 36(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months on the initiative of the European Parliament or the Council. Article 34 Committee procedure 1. The Commission shall be assisted by the Committee on aromatised wine products. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. In the case of implementing acts referred to in the first subparagraph of Article 4(3) and Article 29(1)(b), where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 35 Repeal Regulation (EEC) No 1601/91 is hereby repealed as from 28 March 2015. References made to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex III to this Regulation. Article 36 Transitional measures 1. In order to facilitate the transition from the rules provided for in Regulation (EEC) No 1601/91 to those established by this Regulation, the Commission shall be empowered to adopt, where appropriate, delegated acts in accordance with Article 33 concerning the adoption of measures to amend or derogate from this Regulation, which shall remain in force until 28 March 2018. 2. Aromatised wine products not meeting the requirements of this Regulation but which have been produced in accordance with Regulation (EEC) No 1601/91 prior to 27 March 2014 may be placed on the market until stocks are exhausted. 3. Aromatised wine products which comply with Articles 1 to 6 and Article 9 of this Regulation and which have been produced prior to 27 March 2014 may be placed on the market until stocks are exhausted, provided that such products comply with Regulation (EEC) No 1601/91 in respect of all aspects not regulated by Articles 1 to 6 and Article 9 of this Regulation. Article 37 Entry into force This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union. It shall apply from 28 March 2015. However, Article 36(1) and (3) shall apply from 27 March 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 26 February 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 43, 15.2.2012, p. 67. (2) Position of the European Parliament of 14 January 2014 (not yet published in the Official Journal) and decision of the Council of 17 February 2014. (3) Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails (OJ L 149, 14.6.1991, p. 1). (4) Commission Regulation (EC) No 122/94 of 25 January 1994 laying down certain detailed rules for the application of Council Regulation (EEC) No 1601/91 on the definition, description and presentation of aromatized wines, aromatized wine-based drinks, and aromatized wine-product cocktails (OJ L 21, 26.1.1994, p. 7). (5) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). (6) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16). (7) Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34). (8) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1). (9) Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (OJ L 39, 13.2.2008, p. 16). (10) Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1). (11) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). (12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (13) Directive 2008/95/EC of the European Parliament of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks (OJ L 299, 8.11.2008, p. 25). (14) Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (OJ L 78, 24.3.2009, p. 1). (15) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). ANNEX I TECHNICAL DEFINITIONS, REQUIREMENTS AND RESTRICTIONS (1) Flavouring (a) The following products are authorised for the flavouring of aromatised wines: (i) natural flavouring substances and/or flavouring preparations as defined in Article 3(2)(c) and (d) of Regulation (EC) No 1334/2008; (ii) flavourings as defined in Article 3(2)(a) of Regulation (EC) No 1334/2008, which: \u2014 are identical to vanillin, \u2014 smell and/or taste of almonds, \u2014 smell and/or taste of apricots, \u2014 smell and/or taste of eggs; and (iii) aromatic herbs and/or spices and/or flavouring foodstuffs. (b) The following products are authorised for the flavouring of aromatised wine-based drinks and aromatised wine-product cocktails: (i) flavouring substances and/or flavouring preparations as defined in Article 3(2)(b) and (d) of Regulation (EC) No 1334/2008; and (ii) aromatic herbs and/or spices and/or flavouring foodstuffs. Addition of such substances confers on the final product organoleptic characteristics other than those of wine. (2) Sweetening The following products are authorised for the sweetening of aromatised wine products: (a) semi-white sugar, white sugar, extra-white sugar, dextrose, fructose, glucose syrup, sugar solution, invert sugar solution, invert sugar syrup, as defined in Council Directive 2001/111/EC (1); (b) grape must, concentrated grape must and rectified concentrated grape must, as defined in points 10, 13 and 14 of Part II of Annex VII to Regulation (EU) No 1308/2013; (c) burned sugar, which is the product obtained exclusively from the controlled heating of sucrose without bases, mineral acids or other chemical additives; (d) honey as defined in Council Directive 2001/110/EC (2); (e) carob syrup; (f) any other natural carbohydrate substances having a similar effect to those products. (3) Addition of alcohol The following products are authorised for the preparation of some aromatised wines and, some aromatised wine-based drinks: (a) ethyl alcohol of agricultural origin, as defined in Annex I, point 1, to Regulation (EC) No 110/2008, including viticultural origin; (b) wine alcohol or dried grape alcohol; (c) wine distillate or dried grape distillate; (d) distillate of agricultural origin, as defined in Annex I, point 2, to Regulation (EC) No 110/2008; (e) wine spirit, as defined in Annex II, point 4, to Regulation (EC) No 110/2008; (f) grape-marc spirit, as defined in Annex II, point 6, to Regulation (EC) No 110/2008; (g) spirit drinks distilled from fermented dried grapes. The ethyl alcohol used to dilute or dissolve colorants, flavourings or any other authorised additives used in the preparation of aromatised wine products must be of agricultural origin and must be used in the dose strictly necessary and is not considered as addition of alcohol for the purpose of production of an aromatised wine product. (4) Additives and colouring The rules on food additives, including colours, laid down in Regulation (EC) No 1333/2008 apply to aromatised wine products. (5) Addition of water For the preparation of aromatised wine products, the addition of water is authorised provided that it is used in the dose necessary: \u2014 to prepare flavouring essence, \u2014 to dissolve colorants and sweeteners, \u2014 to adjust the final composition of the product. The quality of the water added has to be in conformity with Directive 2009/54/EC of the European Parliament and of the Council (3) and Council Directive 98/83/EC (4), and it should not change the nature of the product. This water may be distilled, demineralised, permuted or softened. (6) For the preparation of aromatised wine products, the addition of carbon dioxide is authorised. (7) Alcoholic strength \u2018Alcoholic strength by volume\u2019 means the ratio of the volume of pure alcohol contained in the product in question at a temperature of 20 \u00b0C to the total volume of that product at the same temperature. \u2018Actual alcoholic strength by volume\u2019 means the number of volumes of pure alcohol contained at a temperature of 20 \u00b0C in 100 volumes of the product at that temperature. \u2018Potential alcoholic strength by volume\u2019 means the number of volumes of pure alcohol at a temperature of 20 \u00b0C capable of being produced by total fermentation of the sugars contained in 100 volumes of the product at the same temperature. \u2018Total alcoholic strength by volume\u2019 means the sum of the actual and potential alcoholic strengths by volume. (1) Council Directive 2001/111/EC of 20 December 2001 relating to certain sugars intended for human consumption (OJ L 10, 12.1.2002, p. 53). (2) Council Directive 2001/110/EC of 20 December 2001 relating to honey (OJ L 10, 12.1.2002, p. 47). (3) Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (recast) (OJ L 164, 26.6.2009, p. 45). (4) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32). ANNEX II SALES DENOMINATIONS AND DESCRIPTIONS OF AROMATISED WINE PRODUCTS A. SALES DENOMINATIONS AND DESCRIPTIONS OF AROMATISED WINES (1) Aromatised wine Products complying with the definition set out in Article 3(2). (2) Wine-based aperitif Aromatised wine to which alcohol may have been added. The use of the term \u2018aperitif\u2019 in this connection is without prejudice to its use to define products which do not fall within the scope of this Regulation. (3) Vermouth Aromatised wine: \u2014 to which alcohol has been added, and \u2014 whose characteristic taste has been obtained by the use of appropriate substances of Artemisia species. (4) Bitter aromatised wine Aromatised wine with a characteristic bitter flavour to which alcohol has been added. The sales denomination \u2018bitter aromatised wine\u2019 is followed by the name of the main bitter-flavouring substance. The sales denomination \u2018bitter aromatised wine\u2019 may be supplemented or replaced by the following terms: \u2014 \u2018Quinquina wine\u2019, whose main flavouring is natural quinine flavouring, \u2014 \u2018Bitter vino\u2019, whose main flavouring is natural gentian flavouring and which has been coloured with authorised yellow and/or red colour; the use of the word \u2018bitter\u2019 in this connection is without prejudice to its use to define products which do not fall within the scope of this Regulation, \u2014 \u2018Americano\u2019, where the flavouring is due to the presence of natural flavouring substances derived from wormwood and gentian and which has been coloured with authorised yellow and/or red colours. (5) Egg-based aromatised wine Aromatised wine: \u2014 to which alcohol has been added, \u2014 to which good-quality egg yolk or extracts thereof have been added, \u2014 which has a sugar content expressed in terms of invert sugar of more than 200 grams, and \u2014 in the preparation of which the minimum quantity of egg yolk used in the mixture is 10 grams per litre. The sales denomination \u2018egg-based aromatised wine\u2019 may be accompanied by the term \u2018cremovo\u2019 where such product contains wine of the protected designation of origin \u2018Marsala\u2019 in a proportion of not less than 80 %. The sales denomination \u2018egg-based aromatised wine\u2019 may be accompanied by the term \u2018cremovo zabaione\u2019, where such product contains wine of the protected designation of origin \u2018Marsala\u2019 in a proportion of not less than 80 % and has an egg yolk content of not less than 60 grams per litre. (6) V\u00e4kev\u00e4 viinigl\u00f6gi/Starkvinsgl\u00f6gg An aromatised wine: \u2014 to which alcohol has been added, and \u2014 whose characteristic taste has been obtained by the use of cloves and/or cinnamon. B. SALES DENOMINATIONS AND DESCRIPTIONS OF AROMATISED WINE BASED DRINKS (1) Aromatised wine-based drink Products complying with the definition set out in Article 3(3). (2) Aromatised fortified wine-based drink Aromatised wine-based drink \u2014 to which alcohol has been added, \u2014 which has actual alcoholic strength by volume not less than 7 % vol., \u2014 which has been sweetened, \u2014 which is obtained from white wine, \u2014 to which dried grape distillate has been added, and \u2014 which has been flavoured exclusively by cardamom extract; or \u2014 to which alcohol has been added, \u2014 which has actual alcoholic strength by volume not less than 7 % vol., \u2014 which has been sweetened, \u2014 which is obtained from red wine, and \u2014 to which flavouring preparations obtained exclusively from spices, ginseng, nuts, citrus fruit essences and aromatic herbs, have been added. (3) Sangr\u00eda/Sangria Aromatised wine-based drink \u2014 which is obtained from wine, \u2014 which is aromatised with the addition of natural citrus-fruit extracts or essences, with or without the juice of such fruit, \u2014 to which spices may have been added, \u2014 to which carbon dioxide may have been added, \u2014 which has not been coloured, \u2014 which have an actual alcoholic strength by volume of not less than 4,5 % vol., and less than 12 % vol., and \u2014 which may contain solid particles of citrus-fruit pulp or peel and its colour must come exclusively from the raw materials used. \u2018Sangr\u00eda\u2019 or \u2018Sangria\u2019 may be used as a sales denomination only when the product is produced in Spain or Portugal. When the product is produced in other Member States, \u2018Sangr\u00eda\u2019 or \u2018Sangria\u2019 may only be used to supplement the sales denomination \u2018aromatised wine-based drink\u2019, provided that it is accompanied by the words: \u2018produced in \u2026\u2019, followed by the name of the Member State of production or of a more restricted region. (4) Clarea Aromatised wine-based drink, which is obtained from white wine under the same conditions as for Sangr\u00eda/Sangria. \u2018Clarea\u2019 may be used as a sales denomination only when the product is produced in Spain. When the product is produced in other Member States, \u2018Clarea\u2019 may only be used to supplement the sales denomination \u2018aromatised wine-based drink\u2019, provided that it is accompanied by the words: \u2018produced in \u2026\u2019, followed by the name of the Member State of production or of a more restricted region. (5) Zurra Aromatised wine-based drink obtained by adding brandy or wine spirit as defined in Regulation (EC) No 110/2008 to Sangr\u00eda/Sangria and Clarea, possibly with the addition of pieces of fruit. The actual alcoholic strength by volume must be not less than 9 % vol. and less than 14 % vol. (6) Bitter soda Aromatised wine-based drink \u2014 which is obtained from \u2018bitter vino\u2019 the content of which in the finished product must not be less than 50 % by volume, \u2014 to which carbon dioxide or carbonated water has been added, and \u2014 which has an actual alcoholic strength by volume of not less than 8 % vol., and less than 10,5 % vol.. The use of the word \u2018bitter\u2019 in this context shall be without prejudice to its use to define products which do not fall within the scope of this Regulation. (7) Kalte Ente Aromatised wine-based drink \u2014 which is obtained by mixing wine, semi-sparkling wine or aerated semi-sparkling wine with sparkling wine or aerated sparkling wine, \u2014 to which natural lemon substances or extracts thereof have been added, and \u2014 which has an actual alcoholic strength by volume of not less than 7 % vol.. The finished product must contain not less than 25 % by volume of the sparkling wine or aerated sparkling wine. (8) Gl\u00fchwein Aromatised wine-based drink \u2014 which is obtained exclusively from red or white wine, \u2014 which is flavoured mainly with cinnamon and/or cloves, and \u2014 which has an actual alcoholic strength by volume of not less than 7 % vol.. Without prejudice to the quantities of water resulting from the application of Annex I, point 2, the addition of water is forbidden. Where it has been prepared from white wine, the sales denomination \u2018Gl\u00fchwein\u2019 must be supplemented by words indicating white wine, such as the word \u2018white\u2019. (9) Viinigl\u00f6gi/Vingl\u00f6gg/Kar\u0161tas vynas Aromatised wine-based drink \u2014 which is obtained exclusively from red or white wine, \u2014 which is flavoured mainly with cinnamon and/or cloves, and \u2014 which has an actual alcoholic strength by volume of not less than 7 % vol.. Where it has been prepared from white wine, the sales denomination \u2018Viinigl\u00f6gi/Vingl\u00f6gg/Kar\u0161tas vynas\u2019 must be supplemented by words indicating white wine, such as the word \u2018white\u2019. (10) Maiwein Aromatised wine-based drink \u2014 which is obtained from wine in which Galium odoratum (L.) Scop. (Asperula odorata L.), plants or extracts thereof has been added so as to ensure a predominant taste of Galium odoratum (L.) Scop. (Asperula odorata L.), and \u2014 which has an actual alcoholic strength by volume of not less than 7 % vol.. (11) Maitrank Aromatised wine-based drink \u2014 which is obtained from white wine in which Galium odoratum (L.) Scop. (Asperula odorata L.) plants have been macerated or to which extracts thereof have been added with the addition of oranges and/or other fruits, possibly in the form of juice, concentrated or extracts, and with maximum 5 % sugar sweetening, and \u2014 which has an actual alcoholic strength by volume of not less than 7 % vol.. (12) Pelin Aromatised wine-based drink \u2014 which is obtained from red or white wine and specific mixture of herbs, \u2014 which has an actual alcoholic strength by volume of not less than 8,5 % vol., and \u2014 which has a sugar content expressed as invert sugar of 45-50 grams per litre, and a total acidity of not less than 3 grams per litre expressed as tartaric acid. (13) Aromatizovan\u00fd dezert Aromatised wine-based drink \u2014 which is obtained from white or red wine, sugar and dessert spices mixture, \u2014 which has an actual alcoholic strength by volume of not less than 9 % vol. and less than 12 % vol., and \u2014 which has a sugar content expressed as invert sugar of 90-130 grams per litre and a total acidity of at least 2,5 grams per litre expressed as tartaric acid. \u2018Aromatizovan\u00fd dezert\u2019 may be used as a sales denomination only when the product is produced in the Czech Republic. When the product is produced in other Member States, \u2018Aromatizovan\u00fd dezert\u2019 may only be used to supplement the sales denomination \u2018aromatised wine-based drink\u2019 provided that it is accompanied by the words \u2018produced in \u2026\u2019 followed by the name of the Member State of production or of a more restricted region. C. SALES DENOMINATIONS AND DESCRIPTIONS OF AROMATISED WINE-PRODUCT COCKTAILS (1) Aromatised wine-product cocktail Product complying with the definition set out in Article 3(4). The use of the term \u2018cocktail\u2019 in this connection is without prejudice to its use to define products which do not fall within the scope of this Regulation. (2) Wine-based cocktail Aromatised wine-product cocktail \u2014 in which the proportion of concentrated grape must does not exceed 10 % of the total volume of the finished product, \u2014 which has an actual alcoholic strength by volume less than 7 % vol., and \u2014 in which the sugar content, expressed as invert sugar, is less than 80 grams per litre. (3) Aromatised semi-sparkling grape-based cocktail Aromatised wine-product cocktail \u2014 which is obtained exclusively from grape must, \u2014 which has an actual alcoholic strength by volume less than 4 % vol., and \u2014 which contains carbon dioxide obtained exclusively from fermentation of the products used. (4) Sparkling wine cocktail Aromatised wine-product cocktail, which is mixed with sparkling wine. ANNEX III CORRELATION TABLE Regulation (EEC) No 1601/91 This Regulation Article 1 Article 1 Article 2(1) to (4) Article 3 and Annex II Article 2(5) Article 6(1) Article 2(6) Article 6(2) Article 2(7) \u2014 Article 3 Article 4(1) and Annex I Article 4(1) to (3) Article 4(1) and Annex I Article 4(4) Article 4(3) Article 5 Article 4(2) Article 6(1) Article 5(1) and (2) Article 6(2)(a) Article 5(4) Article 6(2)(b) Article 20(1) Article 6(3) Article 5(5) Article 6(4) Article 9 Article 7(1) and (3) \u2014 Article 7(2) Article 5(3) Article 8(1) \u2014 Article 8(2) Article 5(1) and (2) Article 8(3) Article 6(3) \u2014 Article 7 Article 8(4), first and second paragraphs \u2014 Article 8(4) third paragraph Annex I, point 3, second paragraph Article 8(4a) \u2014 Article 8(5) to (8) Article 8 Article 8(9) \u2014 Article 9(1) to (3) Article 31 Article 9(4) Article 32 Article 10 Article 11 Article 10a Article 2, point 3, and Articles 10 to 30 Article 11 Article 1(3) Articles 12 to 15 Articles 33 and 34 \u2014 Article 35 Article 16 Article 36 Article 17 Article 37 Annex I Annex I(3)(a) Annex II \u2014", "summary": "Aromatised wine products Aromatised wine products SUMMARY OF: Regulation (EU) No 251/2014 \u2014 definition, description, presentation, labelling and protection of geographical indications of aromatised wine products SUMMARY WHAT DOES THIS REGULATION DO? This regulation stipulates the specifications of aromatised wine products and protection of their geographical indications. It seeks to ensure high levels of consumer protection, product authenticity, market transparency and fair competition. It applies to all aromatised wine products placed on the market in the EU (whether produced in EU or non-EU countries) and products produced in the EU for export. KEY POINTS \u2014 This regulation establishes specific presentation and labelling rules for aromatised wine products, which apply in addition to other rules in the earlier Regulation (EU) No 1169/2011 on food information to consumers. \u2014 Aromatised wine products include 3 categories: \u2014 aromatised wine*, \u2014 aromatised wine-based drinks*, and \u2014 aromatised wine-product cocktails*. \u2014 Aromatised wine products must be produced in accordance with the requirements, restrictions and descriptions laid down in Annexes I and II of this regulation. \u2014 EU countries can apply for the EU protection of geographical indications for aromatised wine products. FROM WHEN DOES THE REGULATION APPLY? It applies from 27 March 2014. BACKGROUND Council Regulation (EEC) No 1601/91 and Commission Regulation (EC) No 122/94, regulating aromatised wine products proved successful. However, due to technological innovation, market developments and evolving consumer expectations, it was necessary to update the rules on the definition, description, presentation, labelling and protection of geographical indications for these products. KEY TERMS * Aromatised wines: drinks in which the grapevine products represent at least 75 % of the total volume. They have an alcoholic strength of between 14.5 % and 22 % volume. An example is vermouth. * Aromatised wine-based drink: drinks in which the grapevine products represent at least 50 % of the total volume. They have an alcoholic strength of between 4.5 % and 14.5 % volume. Examples include sangria and gl\u00fchwein. * Aromatised wine-product cocktails: drinks in which the grapevine products represent at least 50 % of the total volume. They have an alcoholic strength of between 1.2 % and 10 % volume. ACT Regulation (EU) No 251/2014 of the European Parliament and of the Council of 26 February 2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91 (OJ L 84, 20.3.2014, pp. 14-34) Corrections to Regulation (EU) No 251/2014 have been incorporated in the basic text. This consolidated version is of documentary value only. last update 14.01.2016"}
{"article": "30.1.2020 EN Official Journal of the European Union L 25/1 COUNCIL REGULATION (EU) 2020/123 of 27 January 2020 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(3) thereof, Having regard to the proposal from the European Commission, Whereas: (1) Article 43(3) of the Treaty provides that the Council, on a proposal from the Commission, is to adopt measures on the fixing and allocation of fishing opportunities. (2) Regulation (EU) No 1380/2013 of the European Parliament and of the Council (1) requires that conservation measures be adopted, taking into account available scientific, technical and economic advice, including, where relevant, reports drawn up by the Scientific, Technical and Economic Committee for Fisheries (STECF) and other advisory bodies, as well as any advice received from advisory councils. (3) It is incumbent upon the Council to adopt measures on the fixing and allocation of fishing opportunities, including certain conditions functionally linked thereto, as appropriate. In accordance with Article 16(4) of Regulation (EU) No 1380/2013, fishing opportunities should be fixed in accordance with the objectives of the Common Fisheries Policy (CFP) established in Article 2(2) of that Regulation. In accordance with Article 16(1) of that Regulation, fishing opportunities should be allocated to Member States in such a way as to ensure relative stability of fishing activities of each Member State for each fish stock or fishery. (4) The total allowable catch (TAC) should therefore be established, in line with Regulation (EU) No 1380/2013, on the basis of available scientific advice, taking into account biological and socio-economic aspects whilst ensuring fair treatment between fishing sectors, as well as in the light of the opinions expressed during the consultation of stakeholders, in particular at the meetings of the advisory councils. (5) In accordance with Article 15 of Regulation (EU) No 1380/2013, the landing obligation applies fully from 1 January 2019 and all species subject to catch limits should be landed. Article 16(2) of Regulation (EU) No 1380/2013 provides that, when the landing obligation in respect of a fish stock applies, fishing opportunities are to be fixed taking into account the change from fixing fishing opportunities that reflect landings to fixing fishing opportunities that reflect catches. On the basis of the joint recommendations submitted by the Member States and in accordance with Article 15 of Regulation (EU) No 1380/2013, the Commission adopted a number of delegated Regulations laying down details for the implementation of the landing obligation in the form of specific discard plans applicable on a temporary basis for a maximum period of three years. (6) The fishing opportunities for stocks of species falling under the landing obligation should take into account the fact that discarding is in principle no longer allowed. Therefore, the fishing opportunities should be based on the advice figure for total catches (instead of the advice figure for wanted catches), as provided by the International Council for the Exploration of the Sea (ICES). The amounts that, by way of exception, may continue to be discarded during the operation of the landing obligation should be deducted from that advice figure for total catches. (7) There are certain stocks for which ICES has issued scientific advice for no catches. If TACs for those stocks are established at the level indicated in the scientific advice, the obligation to land all catches, including by-catches from those stocks, in mixed fisheries would lead to the phenomenon of \u2018choke species\u2019. In order to strike the right balance between continuing fisheries in view of the potentially severe socio-economic implications, and the need to achieve a good biological status for those stocks, taking into account the difficulty of fishing all stocks in a mixed fishery at maximum sustainable yield (MSY) at the same time, it is appropriate to establish specific TACs for by-catches for those stocks. The level of those TACs should be such that mortality for those stocks is decreased and that it provides incentives for improvements in selectivity and avoidance. In order to guarantee to the extent possible the use of fishing opportunities in mixed fisheries in accordance with Article 16(2) of Regulation (EU) No 1380/2013, it is appropriate to establish a pool for quota exchanges for those Member States that have no quota to cover their unavoidable by-catches. (8) In order to reduce catches of the stocks for which by-catch TACs are set, fishing opportunities for the fisheries in which fish from those stocks is caught should be set at levels that help the biomass of vulnerable stocks to recover to sustainable levels. Technical and control measures that are intrinsically linked to fishing opportunities should also be established to prevent illegal discarding. (9) According to scientific advice, the spawning-stock biomass of European seabass (Dicentrarchus labrax) in the Celtic Sea, Channel, Irish Sea and southern North Sea (ICES divisions 4b, 4c, 7a, and 7d to 7h) has been declining since 2009 and is currently below MSY Btrigger and just above Blim. The fishing mortality, due to the measures taken by the Union has decreased and is currently below FMSY. However, recruitment is low, fluctuating without trend since 2008. Therefore, the catch limits should be continued, while ensuring that the target fishing mortality for this stock is in line with MSY. (10) In accordance with the Western Waters multiannual plan established by Regulation (EU) 2019/472 of the European Parliament and of the Council (2), the target fishing mortality, in line with the ranges of FMSY defined in Article 2 of that Regulation, is to be achieved as soon as possible, and on progressive and incremental basis by 2020 for the stocks listed in Article 1(1) of that Regulation and shall be maintained thereafter within the ranges of FMSY, in accordance with Article 4 of that Regulation. The overall fishing mortality for seabass in ICES divisions 8a and 8b should therefore be set in line with MSY, taking into account commercial and recreational catches and including discards (2 533 tonnes altogether according to the ICES advice). Member States are to take appropriate measures to ensure that the fishing mortality from their fleets and from their recreational fishermen does not exceed FMSY point value, as required by Article 4(3) of Regulation (EU) 2019/472. (11) Measures for recreational fisheries for European seabass should also be continued, taking account of the significant impact of such fisheries on the stocks concerned. Within the limits of the scientific advice, the catch-and-release practice and the bag limits should be continued. Considering the lack of sufficient selectivity and that higher number of specimens are likely to be caught than the established limits, fixed nets should be excluded. When only the catch-and-release practice is allowed, only the gear ensuring high survival rates should be permitted. Having considered environmental, social and economic circumstances, and especially the dependency of commercial fishermen on those stocks in coastal communities, those measures on European seabass would strike an appropriate balance between the interests of commercial and recreational fishermen. In particular, those measures would allow recreational fishermen to exercise their fishing activities by taking into account their impact on those stocks. (12) As regards the European eel (Anguilla anguilla) stock, ICES has advised that all anthropogenic mortalities, including recreational and commercial fisheries, should be reduced to zero, or kept as close to zero as possible. Moreover, the General Fisheries Commission for the Mediterranean (GFCM) adopted Recommendation GFCM/42/2018/1 establishing management measures for European eel in the Mediterranean. It is appropriate to maintain the level-playing field across the Union and hence to maintain also for the Union waters of the ICES area as well as brackish waters such as estuaries, coastal lagoons and transitional waters a consecutive three-month closure period for all fisheries of European eel at all life stages. As the fishing closure period should be consistent with the conservation objectives set out in Council Regulation (EC) No 1100/2007 (3) and with the temporal migration patterns of European eel, for the Union waters of the ICES area it is appropriate to set it in the period between 1 August 2020 and 28 February 2021. (13) For some years, certain TACs for stocks of elasmobranchs (skates, sharks, rays) have been set at zero, with a linked provision establishing an obligation to immediately release accidental catches. The reason for that specific treatment was the poor conservation status of those stocks and the assumption that discarding, because of high survival rates, would not raise fishing mortality rates and would be beneficial for the conservation of those species. As of 1 January 2019, however, catches of those species have to be landed, unless they are covered by any of the derogations from the landing obligation provided for in Article 15 of Regulation (EU) No 1380/2013. Point (a) of Article 15(4) of that Regulation allows such derogations for species in respect of which fishing is prohibited and which are identified as such in a Union legal act adopted in the area of the CFP. Therefore, it is appropriate to prohibit fishing of those species in the areas concerned. (14) Pursuant to Article 16(4) of Regulation (EU) No 1380/2013, for stocks subject to specific multiannual plans the TACs should be established in accordance with the rules laid down in those plans. (15) The North Sea multiannual plan was established by Regulation (EU) 2018/973 of the European Parliament and of the Council (4) and entered into force in 2018. The Western Waters multiannual plan entered into force in 2019. Fishing opportunities for stocks listed in Article 1 of those plans should be established in accordance with targets (ranges of FMSY) and safeguards in compliance with conditions provided for in those plans. The ranges of FMSY have been identified in the relevant ICES advice. Where no adequate scientific information is available, fishing opportunities for by-catch stocks should be established in accordance with the precautionary approach, as set out in the multiannual plans. In order to limit variations in fishing opportunities between consecutive years, in accordance with point (c) of Article 4(5) of Regulation (EU) 2019/472, it is appropriate to use the upper range of FMSY for the stocks of northern hake and southern hake. (16) In accordance with Article 8 of the Western Waters multiannual plan, where scientific advice indicates that the spawning stock biomass of any of the stocks referred to in Article 1(1) of that plan is below the Blim, further remedial measures must be taken to ensure rapid return of the stock to levels above the level capable of producing MSY. In particular, those remedial measures may include suspending the targeted fishery for the stock concerned and the adequate reduction of fishing opportunities for those stocks and/or other stocks in the fisheries having by-catches of cod or whiting. (17) In its advice, ICES indicated that stocks of cod and whiting in the Celtic Sea are below Blim. Therefore, further remedial measures should be taken for those stocks. Those measures should contribute to the recovery of the stocks concerned and should replace further reduction of fishing opportunities for fisheries in which those stocks are caught. As regards whiting in the Celtic Sea, those measures should consist of technical modifications to characteristics of gear to decrease by-catches of whiting, which are functionally linked to fishing opportunities for fisheries in which those species are being caught. (18) Remedial measures have been taken in 2019 fishing opportunities in respect of the Celtic Sea cod. On that occasion, the TAC for this stock was reserved for by-catches only. However, since the stock is under Blim, further remedial measures should be taken in order to bring the stock above the level capable of producing MSY, in accordance with Article 8(2) of the Western Waters multiannual plan. Such measures would improve selectivity by making the usage of gear that have lower levels of by-catches of cod mandatory in the areas where cod catches are significant, thus decreasing the fishing mortality of this stock in mixed fisheries. The level of the TAC should be established to avoid premature closure of the fishery in early 2020. In addition, the TAC should be such as to avoid potential discarding, which could undermine data collection and scientific assessment of the stock. Establishing the TAC at 805 tonnes would ensure a considerable increase in the stock spawning biomass in 2020 of at least 100 %, in order to ensure rapid return of the stock to levels capable of producing MSY (Btrigger). (19) The TACs for bluefin tuna in the eastern Atlantic and Mediterranean should be established in accordance with the rules laid down in Regulation (EU) 2016/1627 of the European Parliament and of the Council (5). (20) As a result of a benchmark exercise on the stock of herring to the west of Scotland, ICES has provided advice for the combined herring stocks in divisions 6a, 7b and 7c (West of Scotland, West of Ireland). The advice covers two separate TACs (for divisions 6aS, 7b and 7c on the one hand, and for divisions 5b, 6b and 6aN on the other). According to ICES, a rebuilding plan has to be developed for those stocks. Therefore, a TAC should be established to permit limited catches in the framework of a commercially operated scientific sampling programme. (21) According to scientific advice by ICES, the Celtic Sea herring (Clupea harengus) stock (in ICES divisions 7a South of 52\u00b0 30' N, 7g\u2013h, and 7j\u2013k) is below Blim. Therefore, ICES advised that catches in 2020 should be zero tonnes. ICES suggested that a monitoring fishery should be conducted to maximise the contribution to scientific data collection, including assisting with the acoustic survey and that the minimum level of catches should be 869 tonnes. This figure could provide the minimum number of at least 17 samples required for a TAC monitoring. It is thus appropriate to set a TAC for a sentinel fishery for Celtic Sea herring to collect uninterrupted fisheries-dependent catch data, without impairing the recovery of the stock. (22) On 17 December 2018 ICES has published scientific advice on the inter-area flexibility for horse mackerel (Trachurus spp.) between ICES divisions 8c and 9a. ICES advised the inter-area flexibility between those two stocks should not exceed the difference between the catch corresponding to a fishing mortality of Fp.05 and the established TAC. There should also be no transfer of TAC to a stock with a spawning-stock biomass below the limit reference point (Blim). Under the conditions of that scientific advice, the inter-area flexibility (special condition) for horse mackerel between ICES subarea 9 and ICES division 8c for 2020 should be established at 10 %. (23) For stocks for which there is no sufficient or reliable data in order to provide size estimates, management measures and TAC levels should follow the precautionary approach to fisheries management as defined in point (8) of Article 4(1) of Regulation (EU) No 1380/2013, while taking into account stock-specific factors, including, in particular, available information on stock trends and mixed fisheries considerations. (24) Council Regulation (EC) No 847/96 (6) introduced additional conditions for year-to-year management of TACs including, under Articles 3 and 4 of that Regulation, flexibility provisions for precautionary and analytical TACs. Under Article 2 of that Regulation, when establishing the TACs, the Council is to decide to which stocks Article 3 or 4 of that Regulation is not to apply, in particular on the basis of the biological status of the stocks. In 2014, a further year-to-year flexibility mechanism was introduced by Article 15(9) of Regulation (EU) No 1380/2013 for all stocks that are subject to the landing obligation. Therefore, in order to avoid excessive flexibility that would undermine the principle of rational and responsible exploitation of marine biological resources, hinder the achievement of the objectives of the CFP and deteriorate the biological status of the stocks, it should be established that Articles 3 and 4 of Regulation (EC) No 847/96 apply to analytical TACs only where the year-to-year flexibility provided for in Article 15(9) of Regulation (EU) No 1380/2013 is not used. (25) The inter-annual flexibility under Article 15(9) of Regulation (EU) No 1380/2013 should be excluded where the application of this flexibility would undermine the achievement of the CFP objectives, in particular for stocks with spawning biomass below Blim. (26) Moreover, given that the biomass of the stocks of COD/03AS; COD/5BE6A; WHG/56-14; WHG/07A and PLE/7HJK is below Blim and that only by-catch and scientific fisheries are permitted in 2020, Member States have undertaken not to apply Article 15(9) of Regulation (EU) No 1380/2013 for those stocks in 2020 so that catches in 2020 would not exceed the established TACs. (27) Where a TAC relating to a stock is allocated to one Member State only, it is appropriate to empower that Member State, in accordance with Article 2(1) of the Treaty, to determine the level of such TAC. Provisions should be made to ensure that, when fixing that TAC level, the Member State concerned acts in a manner fully consistent with the principles and rules of the CFP. (28) It is necessary to establish the fishing effort ceilings for 2020 in accordance with Articles 5, 6, 7 and 9 of, and Annex I to, Regulation (EU) 2016/1627. (29) In order to guarantee full use of fishing opportunities, it is appropriate to allow for the implementation of a flexible arrangement between certain TAC areas where the same biological stock is concerned. (30) For certain species, such as certain species of sharks, even a limited fishing activity could result in a serious conservation risk. Fishing opportunities for such species should therefore be fully restricted through a general prohibition on fishing those species. (31) At the 12th Conference of the Parties of the Convention on the Conservation of Migratory Species of Wild Animals, held in Manila from 23 to 28 October 2017, a number of species were added to the lists of protected species in Appendices I and II to that Convention. Therefore, it is appropriate to provide for the protection of those species with respect to Union fishing vessels fishing in all waters and non-Union fishing vessels fishing in Union waters. (32) The use of fishing opportunities available to Union fishing vessels set out in this Regulation is subject to Council Regulation (EC) No 1224/2009 (7), and in particular to Articles 33 and 34 of that Regulation, concerning the recording of catches and fishing effort and the notification of data on the exhaustion of fishing opportunities. It is therefore necessary to specify the codes to be used by Member States when sending data to the Commission relating to landings of stocks subject to this Regulation. (33) It is appropriate, following advice from ICES, to maintain a specific system to manage sandeel and associated by-catches in Union waters of ICES divisions 2a and 3a and ICES subarea 4. Given that the ICES scientific advice is expected to become available only in February 2020, it is appropriate to set the TAC and quotas for that stock provisionally at zero until such advice is released. (34) In accordance with the procedure provided for in the agreements or protocols on fisheries relations with Norway (8) and the Faroe Islands (9), the Union has held consultations on fishing rights with those partners. In accordance with the procedure provided for in the agreement and protocol on fisheries relations with Greenland (10), the Joint Committee has established the level of fishing opportunities available for the Union in Greenland waters in 2020. It is therefore necessary to include those fishing opportunities in this Regulation. (35) The Union TAC for Greenland Halibut in international waters of 1 and 2 is without prejudice to the Union\u2019s position on the appropriate Union share in this fishery. (36) At its annual meeting in 2019, the North-East Atlantic Fisheries Commission (NEAFC) was unable to adopt conservation measures for the two redfish stocks in the Irminger Sea. The relevant TACs should be established for those stocks, in line with the positions expressed by the Union in NEAFC. (37) At its annual meeting in 2017, the International Commission for the Conservation of Atlantic Tunas (ICCAT) agreed that in 2018 and 2019, the ICCAT may distribute the unallocated reserves for bluefin tuna for 2019 and 2020, considering in particular the needs of coastal developing ICCAT contracting parties and cooperating non-contracting parties, entities or fishing entities (CPCs) in their artisanal fisheries. That distribution was agreed at the inter-sessional meeting of Panel 2 of ICCAT (Madrid, March 2018) based, for the Union allocation, on the information received from three Member States: Greece, Spain and Portugal. As a result, the Union received specific additional fishing opportunities of 87 tonnes for 2019 and 100 tonnes for 2020 to be used by the Union artisanal fleets in certain Union regions. That allocation of fishing opportunities to the Union was endorsed by ICCAT at its annual meetings in 2018 and 2019. The parameters established by the Council for establishing an allocation key for 2019 between Greece, Spain and Portugal remain valid for 2020. (38) The ICCAT Recommendation 16-05, decreasing for 2020 the TAC for Mediterranean swordfish, should be implemented in Union law. As it is already the case for the stock of bluefin tuna in the eastern Atlantic and Mediterranean, it is appropriate that catches in recreational fisheries of all other ICCAT stocks should be subject to the catch limits as adopted by the ICCAT. (39) At its annual meeting in 2019, ICCAT agreed for the first time on a TAC for the North Atlantic blue shark caught in association with ICCAT fisheries, and on the allocation key. The fishing opportunities for that stock should thus be allocated to the Member States. In addition, ICCAT agreed on an unallocated TAC for Southern Atlantic blue shark caught in association with ICCAT fisheries. Moreover, annual landing limits were allocated among Contracting Parties for the stocks of blue marlin and white marlin/spearfish in the Atlantic Ocean. Those measures should be implemented in Union law. (40) At its annual meeting in 2019, the Parties to the Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) adopted catch limits for both target and by-catch species for the period from 1 December 2019 to 30 November 2020. The uptake of the quotas during 2019 should be considered when setting fishing opportunities for 2020. (41) At its annual meeting in 2019, the Indian Ocean Tuna Commission (IOTC) adopted new catch limits for yellowfin tuna (Thunnus albacares) that do not affect the Union catch limits in the framework of IOTC. However, it reduced possibilities for using fish aggregating devices (FADs) and supply vessels. Measures on the retention of Mobulid rays were adopted. Those measures should be implemented in Union law. (42) The annual meeting of the South Pacific Regional Fisheries Management Organisation (SPRFMO) will be held from 14 to 18 February 2020. The current measures in the SPRFMO Convention Area should be provisionally maintained until such annual meeting is held. (43) At its annual meeting in 2017, the Inter-American Tropical Tuna Commission (IATTC) adopted a conservation measure for yellowfin tuna, bigeye tuna and skipjack tuna for the period 2018\u20132020. It was not revised at its annual meeting in 2019 and should thus continue being implemented in Union law. (44) At its annual meeting in 2019, the Commission for the Conservation of Southern Bluefin Tuna (CCSBT) confirmed the TAC for the southern bluefin tuna for the period 2018\u20132020 adopted at the annual meeting in 2016. Those measures should be implemented in Union law. (45) At its annual meeting in 2019, the South East Atlantic Fisheries Organisation (SEAFO) adopted TACs for the main species under its purview. Those measures should be implemented in Union law. (46) At its annual meeting in 2019, the Western and Central Pacific Fisheries Commission (WCPFC) kept the previously adopted conservation and management measures. Those measures should continue being implemented in Union law. (47) At its 41st annual meeting in 2019, the Northwest Atlantic Fisheries Organisation (NAFO) adopted a number of fishing opportunities for 2020 for certain stocks in subareas 1 to 4 of the NAFO Convention Area. Those measures should be implemented in the Union law. (48) The 6th Meeting of the Parties of the Southern Indian Ocean Fisheries Agreement (SIOFA) in 2019 adopted conservation and management measures for the stocks under the scope of the Agreement. Those measures should be implemented in Union law. (49) As regards the fishing opportunities for snow crab around the area of Svalbard, the Treaty of Paris of 1920 grants equal and non-discriminatory access to resources for all parties to that Treaty, including with respect to fishing. The view of the Union concerning that access, as regards fishing for snow crab on the continental shelf around Svalbard, has been set out in two notes verbales to Norway dated 25 October 2016 and 24 February 2017. In order to ensure that the exploitation of snow crab within the area of Svalbard is made consistent with such non-discriminatory management rules as may be set out by Norway, which enjoys sovereignty and jurisdiction in the area within the limits of the said Treaty, it is appropriate to fix the number of vessels that are authorised to conduct such fishery. The allocation of such fishing opportunities among Member States is limited to 2020. It is recalled that in the Union primary responsibility for ensuring compliance with applicable law lies with the flag Member States. (50) In accordance with the declaration by the Union addressed to the Bolivarian Republic of Venezuela (11), it is necessary to fix the fishing opportunities for snapper available to Venezuela in Union waters. (51) Given that certain provisions are to be applied on a continuous basis, and in order to avoid legal uncertainty during the period between the end of 2020 and the date of entry into force of the Regulation fixing the fishing opportunities for 2021, the provisions concerning prohibitions and closed seasons set out in this Regulation should continue to apply at the beginning of 2021, until the entry into force of the Regulation fixing the fishing opportunities for 2021. (52) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards authorising individual Member States to manage fishing effort allocations in accordance with a kilowatt-day system. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (12). (53) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards granting of additional days at sea for permanent cessation of fishing activities and for enhanced scientific observer coverage as well as establishing formats of spreadsheets for the collection and transmission of information concerning transfer of days at sea between fishing vessels flying the flag of a Member State. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. (54) In order to avoid the interruption of fishing activities and to ensure the livelihood of the fishermen of the Union, this Regulation should apply from 1 January 2020, except for the provisions concerning fishing effort limits, which should apply from 1 February 2020, and certain provisions concerning particular regions, which should have a specific date of application. For reasons of urgency, this Regulation should enter into force immediately after its publication. (55) Certain international measures which create or restrict fishing opportunities for the Union are adopted by the relevant regional fisheries management organisations (RFMOs) at the end of the year and become applicable before the entry into force of this Regulation. It is therefore necessary for the provisions that implement such measures in Union law to apply retroactively. In particular, since the fishing season in the CCAMLR Convention Area runs from 1 December to 30 November, and thus certain fishing opportunities or prohibitions in the CCAMLR Convention Area are laid down for a period of time starting from 1 December 2019, it is appropriate that the relevant provisions of this Regulation apply from that date. Such retroactive application does not prejudice the principle of legitimate expectations as CCAMLR members are forbidden to fish in the CCAMLR Convention Area without authorisation. (56) Fishing opportunities should be used in full compliance with Union law, HAS ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter 1. This Regulation fixes the fishing opportunities available in Union waters and to Union fishing vessels in certain non-Union waters, for certain fish stocks and groups of fish stocks. 2. The fishing opportunities referred to in paragraph 1 include: (a) catch limits for the year 2020 and, where specified in this Regulation, for the year 2021; (b) fishing effort limits for the year 2020, except the fishing effort limits set out in Annex II, which will apply from 1 February 2020 to 31 January 2021; (c) fishing opportunities for the period from 1 December 2019 to 30 November 2020 for certain stocks in the CCAMLR Convention Area; (d) fishing opportunities for certain stocks in the IATTC Convention Area set out in Article 30 for the periods in 2019 and 2020 specified in that Article. Article 2 Scope 1. This Regulation applies to the following vessels: (a) Union fishing vessels; (b) third-country vessels in Union waters. 2. This Regulation also applies to recreational fisheries where such fisheries are expressly referred to in its relevant provisions. Article 3 Definitions For the purposes of this Regulation, the definitions set out in Article 4 of Regulation (EU) No 1380/2013 apply. In addition, the following definitions apply: (a) \u2018third-country vessel\u2019 means a fishing vessel flying the flag of, and registered in, a third country; (b) \u2018recreational fisheries\u2019 means non-commercial fishing activities exploiting marine biological resources such as recreation, tourism or sport; (c) \u2018international waters\u2019 means waters falling outside the sovereignty or jurisdiction of any State; (d) \u2018total allowable catch\u2019 (TAC) means: (i) in fisheries subject to the exemption of the landing obligation referred to in Article 15(4) to (7) of Regulation (EU) No 1380/2013, the quantity of fish that may be landed from each stock each year; (ii) in all other fisheries, the quantity of fish that may be caught from each stock each year; (e) \u2018quota\u2019 means a proportion of the TAC allocated to the Union, a Member State or a third country; (f) \u2018analytical assessment\u2019 means quantitative evaluation of trends in a given stock, based on data about the stock\u2019s biology and exploitation, which scientific review has indicated to be of sufficient quality to provide scientific advice on options for future catches; (g) \u2018mesh size\u2019 means the mesh size of fishing nets as defined in point (34) of Article 6 of Regulation (EU) 2019/1241 of the European Parliament and of the Council (13); (h) \u2018Union fishing fleet register\u2019 means the register set up by the Commission in accordance with Article 24(3) of Regulation (EU) No 1380/2013; (i) \u2018fishing logbook\u2019 means the logbook referred to in Article 14 of Regulation (EC) No 1224/2009. Article 4 Fishing zones For the purposes of this Regulation, the following zone definitions apply: (a) ICES (International Council for the Exploration of the Sea) zones are the geographical areas specified in Annex III to Regulation (EC) No 218/2009 of the European Parliament and of the Council (14); (b) \u2018Skagerrak\u2019 means the geographical area bounded on the west by a line drawn from the Hanstholm lighthouse to the Lindesnes lighthouse and on the south by a line drawn from the Skagen lighthouse to the Tistlarna lighthouse and from that point to the nearest point on the Swedish coast; (c) \u2018Kattegat\u2019 means the geographical area bounded on the north by a line drawn from the Skagen lighthouse to the Tistlarna lighthouse and from that point to the nearest point on the Swedish coast and on the south by a line drawn from Hasen\u00f8re to Gnibens Spids, from Korshage to Spodsbjerg and from Gilbjerg Hoved to Kullen; (d) \u2018Functional Unit 16 of ICES subarea 7\u2019 means the geographical area bounded by rhumb lines sequentially joining the following positions: \u2014 53\u00b0 30' N 15\u00b0 00' W, \u2014 53\u00b0 30' N 11\u00b0 00' W, \u2014 51\u00b0 30' N 11\u00b0 00' W, \u2014 51\u00b0 30' N 13\u00b0 00' W, \u2014 51\u00b0 00' N 13\u00b0 00' W, \u2014 51\u00b0 00' N 15\u00b0 00' W; (e) \u2018Functional Unit 25 of ICES division 8c\u2019 means the geographical sea area bounded by rhumb lines sequentially joining he following positions: \u2014 43\u00b0 00' N 9\u00b0 00' W, \u2014 43\u00b0 00' N 10\u00b0 00' W, \u2014 43\u00b0 30' N 10\u00b0 00' W, \u2014 43\u00b0 30' N 9\u00b0 00' W, \u2014 44\u00b0 00' N 9\u00b0 00' W, \u2014 44\u00b0 00' N 8\u00b0 00' W, \u2014 43\u00b0 30' N 8\u00b0 00' W; (f) \u2018Functional Unit 26 of ICES division 9a\u2019 means the geographical area bounded by rhumb lines sequentially joining the following positions: \u2014 43\u00b0 00' N 8\u00b0 00' W, \u2014 43\u00b0 00' N 10\u00b0 00' W, \u2014 42\u00b0 00' N 10\u00b0 00' W, \u2014 42\u00b0 00' N 8\u00b0 00' W; (g) \u2018Functional Unit 27 of ICES division 9a\u2019 means the geographical area bounded by rhumb lines sequentially joining the following positions: \u2014 42\u00b0 00' N 8\u00b0 00' W, \u2014 42\u00b0 00' N 10\u00b0 00' W, \u2014 38\u00b0 30' N 10\u00b0 00' W, \u2014 38\u00b0 30' N 9\u00b0 00' W, \u2014 40\u00b0 00' N 9\u00b0 00' W, \u2014 40\u00b0 00' N 8\u00b0 00' W; (h) \u2018Functional Unit 30 of ICES division 9a\u2019 means the geographical area under the jurisdiction of Spain in the Gulf of C\u00e1diz and in the adjacent waters of 9a; (i) \u2018Functional Unit 31 of ICES division 8c\u2019 means the geographical sea area bounded by rhumb lines sequentially joining the following positions: \u2014 43\u00b0 30' N 6\u00b0 00' W, \u2014 44\u00b0 00' N 6\u00b0 00' W, \u2014 44\u00b0 00' N 2\u00b0 00' W, \u2014 43\u00b0 30' N 2\u00b0 00' W; (j) \u2018Gulf of C\u00e1diz\u2019 means the geographical area of ICES division 9a east of longitude 7\u00b0 23' 48\u2033 W; (k) \u2018CCAMLR Convention Area\u2019 is the geographical area defined in point (a) of Article 2of Council Regulation (EC) No 601/2004 (15); (l) CECAF (Committee for Eastern Central Atlantic Fisheries) areas are the geographical areas specified in Annex II to Regulation (EC) No 216/2009 of the European Parliament and of the Council (16); (m) \u2018IATTC Convention Area\u2019 is the geographical area defined in the Convention for the Strengthening of the Inter-American Tropical Tuna Commission established by the 1949 Convention between the United States of America and the Republic of Costa Rica (17); (n) \u2018ICCAT Convention Area\u2019 is the geographical area defined in the International Convention for the Conservation of Atlantic Tunas (18); (o) \u2018IOTC Area of Competence\u2019 is the geographical area defined in the Agreement for the establishment of the Indian Ocean Tuna Commission (19); (p) NAFO areas are the geographical areas specified in Annex III to Regulation (EC) No 217/2009 of the European Parliament and of the Council (20); (q) \u2018SEAFO Convention Area\u2019 is the geographical area defined in the Convention on the Conservation and Management of Fishery Resources in the South-East Atlantic Ocean (21); (r) \u2018SIOFA Agreement Area\u2019 is the geographic area defined in the Southern Indian Ocean Fisheries Agreement (22); (s) \u2018SPRFMO Convention Area\u2019 is the geographical area defined in the Convention on the Conservation and Management of High Seas Fishery Resources in the South Pacific Ocean (23); (t) \u2018WCPFC Convention Area\u2019 is the geographical area defined in the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (24); (u) \u2018high seas of the Bering Sea\u2019 is the geographical area of the high seas of the Bering Sea beyond 200 nautical miles from the baselines from which the breadth of the territorial sea of the coastal States of the Bering Sea is measured; (v) \u2018overlap area between IATTC and WCPFC\u2019 is the geographical area defined by the following limits: \u2014 longitude 150\u00b0 W, \u2014 longitude 130\u00b0 W, \u2014 latitude 4\u00b0 S, \u2014 latitude 50\u00b0 S. TITLE II FISHING OPPORTUNITIES FOR UNION FISHING VESSELS CHAPTER I General provisions Article 5 TACs and allocations 1. The TACs for Union fishing vessels in Union waters or in certain non-Union waters and the allocation of such TACs among Member States, and the conditions functionally linked thereto, where appropriate, are set out in Annex I. 2. Union fishing vessels shall be authorised to fish, within the TACs set out in Annex I to this Regulation, in waters falling within the fisheries jurisdiction of the Faroe Islands, Greenland and Norway, and the fishing zone around Jan Mayen, subject to the condition set out in Article 18 of, and Part A of Annex V to, this Regulation and in Regulation (EU) 2017/2403 of the European Parliament and of the Council (25) and its implementing provisions. Article 6 TACs to be determined by Member States 1. The TACs for certain fish stocks shall be determined by the Member State concerned. Those stocks are identified in Annex I. 2. The TACs to be determined by a Member State shall: (a) be consistent with the principles and rules of the CFP, in particular the principle of sustainable exploitation of the stock; and (b) result: (i) if an analytical assessment is available, in the exploitation of the stock in line with MSY from 2020 onwards, with as high a probability as possible, or (ii) if an analytical assessment is unavailable or incomplete, in the exploitation of the stock consistent with the precautionary approach to fisheries management. 3. By 15 March 2020, each Member State concerned shall submit the following information to the Commission: (a) the TACs adopted; (b) the data collected and assessed by the Member State concerned on which the TACs adopted are based; (c) details on how the TACs adopted comply with paragraph 2. Article 7 Conditions for landing catches and by-catches 1. Catches that are not subject to the landing obligation under Article 15 of Regulation (EU) No 1380/2013 shall be retained on board or landed only if they: (a) have been taken by vessels flying the flag of a Member State having a quota and that quota has not been exhausted, or (b) consist of a share in a Union quota which has not been allocated by quota among Member States, and that Union quota has not been exhausted. 2. The stocks of non-target species within safe biological limits referred to in Article 15(8) of Regulation (EU) No 1380/2013 are identified in Annex I to this Regulation for the purposes of the derogation from the obligation to count catches against the relevant quotas provided for in that Article. Article 8 Quota-exchange mechanism for TACs for unavoidable by-catches with regard to the landing obligation 1. In order to take into account the introduction of the landing obligation and to make quotas for certain by-catches available to Member States without a quota, the quota-exchange mechanism set out in paragraphs 2\u20135 of this Article shall apply to the TACs identified in Annex IA. 2. 6 % of each quota from the TACs for cod in the Celtic Sea, cod in the West of Scotland, whiting in the Irish Sea and plaice in ICES divisions 7h, 7j and 7k, and 3 % of each quota from the TAC for West of Scotland whiting, allocated to each Member State, shall be made available for a pool for quota exchanges, which shall open as of 1 January 2020. Member States without quota shall have exclusive access to the quota pool until 31 March 2020. 3. The quantities drawn from the pool may not be exchanged or transferred to the following year. Any unused quantities shall be returned, after 31 March 2020, to those Member States that have initially contributed to the pool for quota exchanges. 4. The quotas provided in return shall be preferably taken from a list of TACs identified by each Member State contributing to the pool as listed in the Appendix to Annex IA. 5. Those quotas shall be of equivalent commercial value by using a market exchange rate or other mutually acceptable exchange rates. In absence of alternatives, the equivalent economic value in accordance to the average Union prices of the previous year, as provided by the European Market Observatory for Fisheries and Aquaculture Products, shall be used. 6. In cases where the quota-exchange mechanism set out in paragraphs 2\u20135 of this Article does not allow Member States to cover their unavoidable by-catches to a similar extent, Member States shall endeavour to agree on quota exchanges pursuant to Article 16(8) of Regulation (EU) No 1380/2013, ensuring that quotas exchanged are of equivalent commercial value. Article 9 Fishing effort limits in ICES division 7e 1. For the periods referred to in point (b) of Article 1(2), the technical aspects of the rights and obligations related to Annex II for the management of the sole stock in ICES division 7e are set out in Annex II. 2. The Commission may, by means of implementing acts, allocate a requesting Member State a number of days at sea additional to those referred to in point 5 of Annex II, on which a vessel may be authorised by its flag Member State to be present within ICES division 7e when carrying on board any regulated gear, on the basis of such a request by that Member State, in accordance with point 7.4 of Annex II. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 53(2). 3. The Commission may, by means of implementing acts, allocate a requesting Member State a maximum of three days between 1 February 2020 and 31 January 2021 additional to those referred to in point 5 of Annex II, on which a vessel may be present within ICES division 7e on the basis of an enhanced programme of scientific observer coverage as referred to in point 8.1 of Annex II. Such an allocation shall be done on the basis of the description submitted by the Member State in accordance with point 8.3 of Annex II and following consultation with the STECF. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 53(2). Article 10 Measures on European seabass fisheries 1. It shall be prohibited for Union fishing vessels, as well as for any commercial fisheries from shore, to fish for European seabass in ICES divisions 4b and 4c, and in ICES subarea 7. It shall be prohibited to retain, tranship, relocate or land European seabass caught in that area. 2. By way of derogation from paragraph 1, in January 2020 and from 1 April to 31 December 2020, Union fishing vessels in ICES divisions 4b, 4c, 7d, 7e, 7f and 7h and in waters within 12 nautical miles from baselines under the sovereignty of the United Kingdom in ICES divisions 7a and 7g may fish for European seabass, and retain, tranship, relocate or land European seabass caught in that area with the following gear and within the following limits: (a) using demersal trawls (26), for unavoidable by-catches not exceeding 520 kilogrammes per two months and 5 % of the weight of the total catches of marine organisms on board caught by that vessel per fishing trip; (b) using seines (27), for unavoidable by-catches not exceeding 520 kilogrammes per two months and 5 % of the weight of the total catches of marine organisms on board caught by that vessel per fishing trip; (c) using hooks and lines (28), not exceeding 5,7 tonnes per vessel per year; (d) using fixed gillnets (29), for unavoidable by-catches not exceeding 1,4 tonnes per vessel per year. The derogations set out in the first subparagraph shall apply to Union fishing vessels that have recorded catches of European seabass over the period from 1 July 2015 to 30 September 2016: in point (c) with recorded catches using hooks and lines, and in point (d) with recorded catches using fixed gillnets. In the case of a replacement of a Union fishing vessel, Member States may allow the derogation to apply to another fishing vessel provided that the number of Union fishing vessels subject to the derogation and their overall fishing capacity do not increase. 3. The catch limits set out in paragraph 2 shall not be transferable between vessels and, where a monthly limit applies, from one month to another. For Union fishing vessels using more than one gear in a single calendar month, the lowest catch limit set out in paragraph 2 for either gear shall apply. Member States shall report to the Commission all catches of European seabass per type of gear no later than 15 days after the end of each month. 4. France and Spain shall ensure that fishing mortality of seabass stock in ICES divisions 8a and 8b from their commercial and recreational fisheries do not exceed the FMSY point value resulting in 2 533 tonnes of total catches, as required by Article 4(3) of Regulation (EU) 2019/472. 5. In recreational fisheries, including from shore, in ICES divisions 4b, 4c, 6a, 7a to 7k: (a) from 1 January to 29 February and from 1 to 31 December 2020, only catch-and-release fishing with a rod or a handline for European seabass shall be allowed. During those periods, it shall be prohibited to retain, relocate, tranship or land European seabass caught in that area; (b) from 1 March to 30 November 2020, not more than two specimens of European seabass may be caught and retained per fisherman per day; the minimum size of European seabass retained shall be 42 cm. Point (b) of the first subparagraph shall not apply to fixed nets, which may not be used to catch or retain European seabass during the period referred to in that point. 6. In recreational fisheries in ICES divisions 8a and 8b, a maximum of two specimens of European seabass may be caught and retained per fisherman per day. The minimum size of European seabass retained shall be 42 cm. This paragraph shall not apply to fixed nets, which may not be used to catch or retain European seabass. 7. Paragraphs 5 and 6 shall be without prejudice to more stringent national measures on recreational fisheries. Article 11 Measures on European eel fisheries in Union waters of the ICES area Any targeted, incidental and recreational fishery of European eel shall be prohibited in Union waters of the ICES area and brackish waters such as estuaries, coastal lagoons and transitional waters for a consecutive three-month period to be determined by each Member State concerned between 1 August 2020 and 28 February 2021. Member States shall communicate the determined period to the Commission no later than 1 June 2020. Article 12 Special provisions on allocations of fishing opportunities 1. The allocation of fishing opportunities among Member States as set out in this Regulation shall be without prejudice to: (a) exchanges made pursuant to Article 16(8) of Regulation (EU) No 1380/2013; (b) deductions and reallocations made pursuant to Article 37 of Regulation (EC) No 1224/2009; (c) reallocations made pursuant to Articles 12 and 47 of Regulation (EU) 2017/2403; (d) additional landings allowed under Article 3 of Regulation (EC) No 847/96 and Article 15(9) of Regulation (EU) No 1380/2013; (e) quantities withheld in accordance with Article 4 of Regulation (EC) No 847/96 and Article 15(9) of Regulation (EU) No 1380/2013; (f) deductions made pursuant to Articles 105, 106 and 107 of Regulation (EC) No 1224/2009; (g) quota transfers and exchanges pursuant to Article 19 of this Regulation. 2. Stocks which are subject to precautionary or analytical TACs are identified in Annex I to this Regulation for the purposes of the year-to-year management of TACs and quotas provided for in Regulation (EC) No 847/96. 3. Except where otherwise specified in Annex I to this Regulation, Article 3 of Regulation (EC) No 847/96 shall apply to stocks subject to a precautionary TAC, and Article 3(2) and (3) and Article 4 of that Regulation shall apply to stocks subject to an analytical TAC. 4. Articles 3 and 4 of Regulation (EC) No 847/96 shall not apply where a Member State uses the year-to-year flexibility provided for in Article 15(9) of Regulation (EU) No 1380/2013. Article 13 Remedial measures for cod and whiting in the Celtic Sea 1. The following measures shall apply to Union vessels fishing with bottom trawls and seines in ICES divisions from 7f, 7g, the part of 7h North of latitude 49\u00b0 30' North and the part of 7j North of latitude 49\u00b0 30' North and East of longitude 11\u00b0 West: (a) Union vessels fishing with bottom trawls whose catches consist of at least 20 % of haddock shall be prohibited from fishing in the area referred to in paragraph 1 unless they use gear with one of the following mesh sizes: \u2014 110 mm cod-end with 120 mm square-mesh panel, \u2014 100 mm T90 cod-end, \u2014 120 mm cod-end, \u2014 100 mm with 160 mm square-mesh panel until 31 May 2020; (b) As from 1 June 2020, in addition to measures referred to in point (a), Union vessels shall use: (i) a fishing gear that is constructed with a minimum of one meter spacing between the fishing line and ground gear, or (ii) any means proven to be at least equally selective for avoidance of cod, according to the assessment by ICES or the STECF; (c) Union vessels fishing with bottom seines whose catches consist of at least 20 % of haddock shall be prohibited from fishing in the area referred to in paragraph 1 unless they use gear with one of the following mesh sizes: \u2014 110 mm cod-end with 120 mm square-mesh panel, \u2014 100 mm T90 cod-end, \u2014 120 mm cod-end. 2. Except vessels falling within the scope of Article 9(2) of the Commission Delegated Regulation (EU) 2018/2034 (30), Union vessels fishing with bottom trawls and seines in ICES divisions from 7f to 7k and in the area west of 5\u00b0 W longitude in ICES division 7e, or Union vessels fishing with bottom trawls in the area of paragraph 1 whose catches consist of less than 20 % of haddock, shall be prohibited from fishing unless they use a minimum cod-end mesh size of at least 100 mm. This minimum cod-end mesh size requirement does not apply to vessels whose by-catches of cod do not exceed 1,5 %, as assessed by the STECF. 3. According to Article 15 of Regulation (EU) No 1380/2013 and Article 27(2) of Regulation (EU) 2019/1241, the catch percentages shall be calculated as the proportion by live weight of all marine biological resources landed after each fishing trip. 4. Union vessels may deploy an alternative highly selective gear to those listed in points (a) and (b) of paragraph 1, the technical attributes of which result, according to a scientific study assessed by the STECF, in catches of less than 1 % of cod. Article 14 Remedial measures for cod in the North Sea The closed areas to fishing, except with pelagic gear (purse seines and trawls), and the periods during which the closures apply are set out in Annex IV. Article 15 Remedial measures for cod in Kattegat 1. As from 31 May 2020, Union vessels fishing with bottom trawls (gear codes: OTB, OTT, OT, TBN, TBS, TB, TX and PTB) with minimum mesh size of 70 mm shall use one of the following selective gear: (a) a sorting grid with maximum 35 mm bar spacing, with an unblocked fish outlet; (b) a sorting grid with maximum 50 mm bar spacing separating flatfish and roundfish, with an unblocked fish outlet for roundfish; (c) Seltra panel with 300 mm square-mesh size; (d) a regulated highly selective gear, the technical attributes of which result, according to the scientific study assessed by the STECF, in catches of less than 1,5 % of cod, if it is the only gear that the vessel carries on board. 2. By 31 March 2020 Member States may identify Union vessels that will have, in a project of a Member State concerned, at the latest on 31 December 2020, equipment installed for fully documented fisheries. Those Union vessels may use gear in accordance with Regulation (EU) 2019/1241. Member States concerned shall communicate the list of those vessels to the Commission. Article 16 Prohibited species 1. It shall be prohibited for Union fishing vessels to fish for, to retain on board, to tranship or to land the following species: (a) starry ray (Amblyraja radiata) in Union waters of ICES divisions 2a, 3a and 7d and ICES subarea 4; (b) leafscale gulper shark (Centrophorus squamosus) in Union waters of ICES division 2a and subarea 4 and in Union and international waters of ICES subareas 1 and 14; (c) Portuguese dogfish (Centroscymnus coelolepis) in Union waters of ICES division 2a and subarea 4 and in Union and international waters of ICES subareas 1 and 14; (d) kitefin shark (Dalatias licha) in Union waters of ICES division 2a and subarea 4 and in Union and international waters of ICES subareas 1 and 14; (e) birdbeak dogfish (Deania calcea) in Union waters of ICES division 2a and subarea 4 and in Union and international waters of ICES subareas 1 and 14; (f) common skate (Dipturus batis) complex (Dipturus cf. flossada and Dipturus cf. intermedia) in Union waters of ICES division 2a and ICES subareas 3, 4, 6, 7, 8, 9 and 10; (g) great lanternshark (Etmopterus princeps) in Union waters of ICES division 2a and subarea 4 and in Union and international waters of ICES subareas 1 and 14; (h) tope shark (Galeorhinus galeus) when taken with longlines in Union waters of ICES division 2a and subarea 4 and in Union and international waters of ICES subareas 1, 5, 6, 7, 8, 12 and 14; (i) porbeagle (Lamna nasus) in all waters; (j) thornback ray (Raja clavata) in Union waters of ICES division 3a; (k) undulate ray (Raja undulata) in Union waters of ICES subareas 6 and 10; (l) whale shark (Rhincodon typus) in all waters; (m) common guitarfish (Rhinobatos rhinobatos) in the Mediterranean; (n) picked dogfish (Squalus acanthias) in Union waters of ICES subareas 2, 3, 4, 5, 6, 7, 8, 9 and 10, with the exception of avoidance programmes as set out in Annex IA. 2. When accidentally caught, species referred to in paragraph 1 shall not be harmed. Specimens shall be promptly released. Article 17 Data transmission When, pursuant to Articles 33 and 34 of Regulation (EC) No 1224/2009, Member States submit to the Commission data relating to landings of quantities of stocks caught and fishing effort, they shall use the stock codes set out in Annex I to this Regulation. CHAPTER II Fishing authorisations in third-country waters Article 18 Fishing authorisations 1. The maximum number of fishing authorisations for Union fishing vessels in third-country waters is set out in Part A of Annex V. 2. Where one Member State transfers quota to another Member State (\u2018swap\u2019) in the fishing areas set out in Part A of Annex V to this Regulation on the basis of Article 16(8) of Regulation (EU) No 1380/2013, the transfer shall include an appropriate transfer of fishing authorisations and shall be notified to the Commission. However, the total number of fishing authorisations for each fishing area, as set out in Part A of Annex V to this Regulation, shall not be exceeded. CHAPTER III Fishing opportunities in waters of regional fisheries management organisations Section 1 General provisions Article 19 Quota transfers and exchanges 1. Where, under the rules of a regional fisheries management organisation (RFMO), quota transfers or exchanges between the Contracting Parties to the RFMO are permitted, a Member State (\u2018the Member State concerned\u2019) may discuss with a Contracting Party to the RFMO and, as appropriate, establish a possible outline of an intended quota transfer or exchange. 2. Upon notification to the Commission by the Member State concerned, the Commission may endorse the outline of the intended quota transfer or exchange that the Member State has discussed with the relevant Contracting Party to the RFMO. Thereupon, the Commission shall express, without undue delay, the consent to be bound by such quota transfer or exchange with the relevant Contracting Party to the RFMO. The Commission shall notify the secretariat of the RFMO of the agreed quota transfer or exchange in accordance with the rules of that organisation. 3. The Commission shall inform the Member States of the agreed quota transfer or exchange. 4. The fishing opportunities received from or transferred to the relevant Contracting Party to the RFMO under the quota transfer or exchange shall be deemed to be quotas allocated to, or deducted from, the allocation of the Member State concerned, as of the moment that the quota transfer or exchange takes effect in accordance with the terms of the agreement reached with the relevant Contracting Party to the RFMO or in accordance with the rules of the relevant RFMO, as appropriate. Such allocation shall not change the existing distribution key for the purpose of allocating fishing opportunities among Member States in accordance with the principle of relative stability of fishing activities. 5. This Article shall apply until 31 January 2021 for quota transfers from a RFMO Contracting Party to the Union and their subsequent allocation to Member States. Section 2 ICCAT Convention Area Article 20 Fishing, farming and fattening capacity limitations 1. The number of Union bait boats and trolling boats authorised to fish actively for bluefin tuna between 8 kg/75 cm and 30 kg/115 cm in the eastern Atlantic shall be limited as set out in point 1 of Annex VI. 2. The number of Union coastal artisanal fishing vessels authorised to fish actively for bluefin tuna between 8 kg/75 cm and 30 kg/115 cm in the Mediterranean shall be limited as set out in point 2 of Annex VI. 3. The number of Union fishing vessels fishing for bluefin tuna in the Adriatic Sea for farming purposes authorised to fish actively for bluefin tuna between 8 kg/75 cm and 30 kg/115 cm shall be limited as set out in point 3 of Annex VI. 4. The number of fishing vessels authorised to fish for, retain on board, tranship, transport, or land bluefin tuna in the eastern Atlantic and Mediterranean shall be limited as set out in point 4 of Annex VI. 5. The number of traps engaged in bluefin tuna fishery in the eastern Atlantic and Mediterranean shall be limited as set out in point 5 of Annex VI. 6. The bluefin tuna total farming capacity, and the maximum input of wild caught bluefin tuna allocated to the farms in the eastern Atlantic and Mediterranean shall be limited as set out in point 6 of Annex VI. 7. The maximum number of Union fishing vessels authorised to fish for northern albacore as a target species in accordance with Article 12 of Council Regulation (EC) No 520/2007 (31) shall be limited as set out in point 7 of Annex VI to this Regulation. 8. The maximum number of Union fishing vessels of at least 20 metres length that fish for bigeye tuna in the ICCAT Convention Area shall be limited as set out in point 8 of Annex VI. Article 21 Recreational fisheries Where appropriate, Member States shall allocate a specific share for recreational fisheries from their allocated quotas as set out in Annex ID. Article 22 Sharks 1. Retaining on board, transhipping or landing any part or whole carcass of bigeye thresher sharks (Alopias superciliosus) caught in any fishery shall be prohibited. 2. It shall be prohibited to undertake a directed fishery for species of thresher sharks of the Alopias genus. 3. Retaining on board, transhipping or landing any part or whole carcass of hammerhead sharks of the Sphyrnidae family (except for the Sphyrna tiburo) caught in fisheries in the ICCAT Convention Area shall be prohibited. 4. Retaining on board, transhipping or landing any part or whole carcass of oceanic whitetip sharks (Carcharhinus longimanus) taken in any fishery shall be prohibited. 5. Retaining on board silky sharks (Carcharhinus falciformis) caught in any fishery shall be prohibited. Section 3 CCAMLR Convention Area Article 23 Exploratory fisheries notifications If a Member State intends to participate in longline exploratory fisheries for toothfish (Dissostichus spp.) in FAO subareas 88.1 and 88.2 as well as in divisions 58.4.1, 58.4.2 and 58.4.3a outside areas of national jurisdiction in 2020, it shall notify the CCAMLR Secretariat in accordance with Articles 7 and 7a of Regulation (EC) No 601/2004 no later than 1 June 2020. Article 24 Limits on exploratory fisheries for toothfish 1. Fishing for toothfish during the 2019-2020 fishing season shall be limited to the Member States, subareas and number of vessels set out in table A of Annex VII for the species, TACs and by-catch limits set out in table B of that Annex. 2. Direct fishing of shark species for purposes other than scientific research shall be prohibited. Any by-catch of shark, especially juveniles and gravid females, taken accidentally in the toothfish fishery shall be released alive. 3. Where applicable, fishing in any small-scale research unit (SSRU) shall be ceased when the reported catch reaches the specified TAC, and the SSRU shall be closed to fishing for the remainder of the season. 4. Fishing shall take place over as large a geographical and bathymetric range as possible to obtain the information necessary to determine fishery potential and to avoid over-concentration of catch and fishing effort. However, fishing in FAO subareas 88.1 and 88.2 as well as in divisions 58.4.1, 58.4.2 and 58.4.3a, where permitted in accordance with paragraph 1, shall be prohibited in depths less than 550 metres. Article 25 Krill fishery during the 2020-2021 fishing season 1. If a Member State intends to fish for krill (Euphausia superba) in the CCAMLR Convention Area during the 2020-2021 fishing season, it shall notify the Commission, no later than 1 May 2020, of its intention to fish for krill, using the format laid down in Part B of the Appendix to Annex VII to this Regulation. On the basis of the information provided by Member States, the Commission shall submit the notifications to the CCAMLR Secretariat no later than 30 May 2020. 2. The notification referred to in paragraph 1 of this Article shall include the information provided for in Article 3 of Regulation (EC) No 601/2004 for each vessel to be authorised by the Member State to participate in the krill fishery. 3. A Member State intending to fish for krill in the CCAMLR Convention Area shall notify its intention to do so only in respect of authorised vessels either flying its flag at the time of the notification or flying the flag of another CCAMLR member that are expected, at the time the fishery takes place, to be flying the flag of that Member State. 4. Member States shall be entitled to authorise participation in a krill fishery by vessels other than those notified to CCAMLR Secretariat in accordance with paragraphs 1, 2 and 3 of this Article, if an authorised vessel is prevented from participation due to legitimate operational reasons or force majeure. In such circumstances the Member States concerned shall immediately inform the CCAMLR Secretariat and the Commission, providing: (a) full details of the intended replacement vessel(s), including information provided for in Article 3 of Regulation (EC) No 601/2004; (b) a comprehensive account of the reasons justifying the replacement and any relevant supporting evidence or references. 5. Member States shall not authorise a vessel placed on any CCAMLR illegal, unreported and unregulated (IUU) fishing vessel list to participate in krill fisheries. Section 4 IOTC Area of Competence Article 26 Limitation of fishing capacity of vessels fishing in the IOTC Area of Competence 1. The maximum number of Union fishing vessels fishing for tropical tunas in the IOTC Area of Competence and the corresponding capacity in gross tonnage shall be as set out in point 1 of Annex VIII. 2. The maximum number of Union fishing vessels fishing for swordfish (Xiphias gladius) and albacore (Thunnus alalunga) in the IOTC Area of Competence and the corresponding capacity in gross tonnage shall be as set out in point 2 of Annex VIII. 3. Member States may reallocate vessels assigned to one of the two fisheries referred to in paragraphs 1 and 2 to the other fishery, provided that they can demonstrate to the Commission that such change does not lead to an increase of fishing effort on the fish stocks involved. 4. Member States shall ensure that, where there is a proposed transfer of capacity to their fleet, vessels to be transferred are on the IOTC record of authorised vessels or on the record of vessels of other tuna RFMOs. Furthermore, no vessels placed on the list of vessels engaged in IUU fishing activities of any RFMO may be transferred. 5. Member States may only increase their fishing capacity beyond the ceilings referred to in paragraphs 1 and 2 within the limits set out in the development plans submitted to the IOTC. Article 27 Drifting FADs and supply vessels 1. A purse seiner shall not deploy more than 300 active drifting FADs at any time. 2. The number of supply vessels shall be no more than two supply vessels in support of not less than five purse seiners, all flying the flag of the same Member State. This provision shall not apply to Member States using only one supply vessel. 3. A single purse seiner shall not be supported by more than one single supply vessel of the same flag Member State at any time. 4. The Union shall not register new or additional supply vessels in the IOTC record of authorised vessels. Article 28 Sharks 1. Retaining on board, transhipping or landing any part or whole carcass of thresher sharks of all the species of the Alopiidae family in any fishery shall be prohibited. 2. Retaining on board, transhipping or landing any part or whole carcass of oceanic whitetip sharks (Carcharhinus longimanus) in any fishery shall be prohibited, except for vessels under 24 metres overall length engaged solely in fishing operations within the exclusive economic zone (EEZ) of the Member State whose flag they fly, and provided that their catch is destined solely for local consumption. 3. When accidentally caught, species referred to in paragraphs 1 and 2 shall not be harmed. Specimens shall be promptly released. Section 5 SPRFMO Convention Area Article 29 Pelagic fisheries 1. Only those Member States which have actively exercised pelagic fisheries activities in the SPRFMO Convention Area in 2007, 2008 or 2009 may fish for pelagic stocks in that area in accordance with the TACs set out in Annex IH. 2. The Member States referred to in paragraph 1 shall limit the total level of gross tonnage of vessels flying their flag and fishing for pelagic stocks in 2020 to the total Union level of 78 600 gross tonnage in that area. 3. The fishing opportunities set out in Annex IH may only be used under the condition that Member States send to the Commission the list of vessels actively fishing or engaged in transhipment in the SPRFMO Convention Area, records from vessel monitoring systems, monthly catch reports and, where available, port calls, at the latest by the fifth day of the following month, with the aim of communicating that information to the SPRFMO Secretariat. Article 30 Mobulid rays 1. It shall be prohibited for Union fishing vessels to fish for, to retain on board, to tranship, to land, to store, to offer for sale or to sell any part or whole carcass of Mobulid rays (Mobulidae family which includes the genera Manta and Mobula), except for fishing vessels carrying out subsistence fishery (where the fish caught are consumed directly by the families of the fishermen). By way of derogation from the first sentence, Mobulid rays that are unintentionally caught by artisanal fishing (fisheries other than longline or surface fisheries, i.e. purse seines, pole and line, gillnet fisheries, hand-line and trolling vessels, and registered in the IOTC record of authorised vessels) may be landed for purposes of local consumption only. 2. All fishing vessels, other than those carrying out subsistence fishery, shall promptly release alive and unharmed, to the extent practicable, Mobulid rays as soon as they are seen in the net, on the hook, or on the deck, and shall do it in a manner that will result in the least possible harm to the individuals captured. Article 31 Bottom fisheries 1. Member States shall limit their bottom fishing catch or effort in 2020 in the SPRFMO Convention Area to those parts of the Convention Area where bottom fishing has occurred from 1 January 2002 to 31 December 2006 and to a level that does not exceed the annual average levels of catches or effort parameters in that period. They may fish beyond the track record only if SPRFMO endorses their plan to fish beyond the track record. 2. Member States without a track record in bottom fishing catch or effort in the SPRFMO Convention Area over the period from 1 January 2002 to 31 December 2006 shall not fish, unless SPRFMO endorses their plan to fish without a track record. Article 32 Exploratory fisheries 1. Member States may participate in longline exploratory fisheries for toothfish (Dissostichus spp.) in the SPRFMO Convention Area in 2020 only if the SPRFMO has approved their application for such fisheries that includes a fisheries operation plan and commitment to implement a data collection plan. 2. Fishing shall take place only in the research blocks specified by SPRFMO. Fishing shall be prohibited in depths less than 750 metres and more than 2 000 metres. 3. The TAC shall be as set out in Annex IH. Fishing shall be limited to one trip of a maximum duration of 21 consecutive days and to a maximum number of 5 000 hooks per set, with a maximum of 20 sets per research block. Fishing shall be ceased either when the TAC is reached or if 100 sets have been set and hauled, whichever is earlier. Section 6 IATTC Convention Area Article 33 Purse-seine fisheries 1. Fishing by purse seiners for yellowfin tuna (Thunnus albacares), bigeye tuna (Thunnus obesus) and skipjack tuna (Katsuwonus pelamis) shall be prohibited: (a) from 00.00 hours on 29 July 2020 to 24.00 hours on 8 October 2020 or from 00.00 hours on 9 November 2020 to 24.00 hours on 19 January 2021 in the area defined by the following limits: \u2014 the Pacific coastlines of the Americas, \u2014 longitude 150\u00b0 W, \u2014 latitude 40\u00b0 N, \u2014 latitude 40\u00b0 S; (b) from 00.00 hours on 9 October 2020 to 24.00 hours on 8 November 2020 in the area defined by the following limits: \u2014 longitude 96\u00b0 W, \u2014 longitude 110\u00b0 W, \u2014 latitude 4\u00b0 N, \u2014 latitude 3\u00b0 S. 2. For each of their vessels, Member States concerned shall notify to the Commission before 1 April 2020 the selected period of closure referred to in point (a) of paragraph 1. All purse seiners of the Member States concerned shall stop purse-seine fishing in the areas defined in paragraph 1 during the selected period. 3. Purse seiners fishing for tuna in the IATTC Convention Area shall retain on board and then land or tranship all yellowfin, bigeye and skipjack tuna caught. 4. Paragraph 3 shall not apply in the following cases: (a) where the fish is considered unfit for human consumption for reasons other than size, or (b) during the final set of a trip when there may be insufficient well space remaining to accommodate all the tuna caught in that set. Article 34 Drifting FADs 1. A purse seiner shall not have more than 450 FADs active at any time in the IATTC Convention Area. A FAD shall be considered active when it is deployed at sea, starts transmitting its location and is being tracked by the vessel, its owner or operator. A FAD shall only be activated on board a purse seiner. 2. A purse seiner may not deploy FADs during the 15 days before the start of the selected closure period referred to in point (a) of Article 33(1), and it shall recover the same number of FADs as initially deployed within 15 days prior to the start of the closure period. 3. Member States shall report to the Commission, on a monthly basis, daily information on all active FADs as required by the IATTC. The reports shall be submitted with a delay of at least 60 days, but not longer than 75 days. The Commission shall transmit that information to the IATTC Secretariat without delay. Article 35 Catch limits for bigeye tuna in longline fisheries The total annual catches of bigeye tuna by longline vessels of each Member State in the IATTC Convention Area are established in Annex IL. Article 36 Prohibition of fishing for oceanic whitetip sharks 1. It shall be prohibited to fish for oceanic whitetip sharks (Carcharhinus longimanus) in the IATTC Convention Area, and to retain on board, to tranship, to land, to store, to offer for sale or to sell any part or whole carcass of oceanic whitetip sharks caught in that area. 2. When accidentally caught, the species referred to in paragraph 1 shall not be harmed. Specimens shall be promptly released by vessel operators. 3. Vessel operators shall: (a) record the number of releases with indication of status (dead or alive); (b) report the information specified in point (a) to the Member State of which they are nationals. Member States shall transmit the information collected during the previous year to the Commission by 31 January. Article 37 Prohibition of fishing for Mobulid rays It shall be prohibited for Union fishing vessels in the IATTC Convention Area to fish for, to retain on board, to tranship, to land, to store, to offer for sale or to sell any part or whole carcass of Mobulid rays (Mobulidae family which includes the genera Manta and Mobula). As soon as Union fishing vessels notice that Mobulid rays have been caught, they shall, wherever possible, promptly release them alive and unharmed. Section 7 SEAFO Convention Area Article 38 Prohibition of fishing for deep-water sharks Directed fishing for the following deep-water sharks in the SEAFO Convention Area shall be prohibited: (a) ghost catshark (Apristurus manis); (b) blurred smooth lanternshark (Etmopterus bigelowi); (c) shorttail lanternshark (Etmopterus brachyurus); (d) great lanternshark (Etmopterus princeps); (e) smooth lanternshark (Etmopterus pusillus); (f) skates (Rajidae); (g) velvet dogfish (Scymnodon squamulosus); (h) deep-sea sharks of the Selachimorpha super-order; (i) picked dogfish (Squalus acanthias). Section 8 WCPFC Convention Area Article 39 Conditions for bigeye tuna, yellowfin tuna, skipjack tuna and south Pacific albacore fisheries 1. Member States shall ensure that the number of fishing days allocated to purse seiners fishing for bigeye tuna (Thunnus obesus), yellowfin tuna (Thunnus albacares) and skipjack tuna (Katsuwonus pelamis) in the part of the WCPFC Convention Area located in the high seas between 20\u00b0 N and 20\u00b0 S does not exceed 403 days. 2. Union fishing vessels shall not target south Pacific albacore (Thunnus alalunga) in the WCPFC Convention Area south of 20\u00b0 S. 3. Member States shall ensure that catches of bigeye tuna (Thunnus obesus) by longliners do not exceed 2 000 tonnes in 2020. Article 40 Management of fishing with FADs 1. In the part of the WCPFC Convention Area located between 20\u00b0 N and 20\u00b0 S, it shall be prohibited for purse seiners to deploy, service or set on FADs between 00.00 hours on 1 July 2020 and 24.00 hours on 30 September 2020. 2. In addition to the prohibition set out in paragraph 1, it shall be prohibited to set on FADs on the high seas of the WCPFC Convention Area, between 20\u00b0 N and 20\u00b0 S, for an additional two months: either from 00.00 hours on 1 April 2020 to 24.00 hours on 31 May 2020, or from 00.00 hours on 1 November 2020 to 24.00 hours on 31 December 2020. 3. Paragraph 2 shall not apply in the following cases: (a) in the final set of a trip, if the vessel has insufficient well space left to accommodate all fish; (b) where the fish is unfit for human consumption for reasons other than size, or (c) when a serious malfunction of freezer equipment occurs. 4. Member States shall ensure that each of its purse seiners have deployed at sea, at any time, no more than 350 FADs with activated instrumented buoys. The buoy shall be activated exclusively on board a vessel. 5. All purse seiners fishing in the part of the WCPFC Convention Area referred to in paragraph 1 shall retain on board, tranship and land all bigeye, yellowfin and skipjack tuna caught. Article 41 Limitations to the number of Union fishing vessels authorised to fish for swordfish The maximum number of Union fishing vessels authorised to fish for swordfish (Xiphias gladius) in areas south of 20\u00b0 S of the WCPFC Convention Area shall be as set out in Annex IX. Article 42 Catch limits for swordfish in longline fisheries south of 20\u00b0 S Member States shall ensure that catches of swordfish (Xiphias gladius) south of 20\u00b0 S by longliners do not exceed in 2020 the limit set out in Annex IG. Member States shall also ensure that there is no shift of the fishing effort for swordfish to the area north of the 20\u00b0 S, as a result of that measure. Article 43 Silky sharks and oceanic whitetip sharks 1. Retaining on board, transhipping, landing or storing any part or whole carcass of the following species in the WCPFC Convention Area shall be prohibited: (a) silky sharks (Carcharhinus falciformis); (b) oceanic whitetip sharks (Carcharhinus longimanus). 2. When accidentally caught, species referred to in paragraph 1 shall not be harmed. Specimens shall be promptly released. Article 44 Overlap area between IATTC and WCPFC 1. Vessels listed exclusively in the WCPFC register shall apply the measures set out in this Section when fishing in the overlap area between IATTC and WCPFC as defined in point (v) of Article 4. 2. Vessels listed in both the WCPFC register and the IATTC register and vessels listed exclusively in the IATTC register shall apply the measures set out in Article 33(1)(a), (2), (3) and (4) and Articles 34, 35 and 36 when fishing in the overlap area between IATTC and WCPFC as defined in point (v) of Article 4. Section 9 Bering Sea Article 45 Prohibition on fishing in the high seas of the Bering Sea Fishing for pollock (Gadus chalcogrammus) in the high seas of the Bering Sea shall be prohibited. Section 10 SIOFA Agreement Area Article 46 Interim bottom fishing measures 1. Member States whose vessels have fished for more than 40 days in any given year in the SIOFA Agreement Area up to 2016 shall ensure that fishing vessels flying their flag limit their annual bottom fishing effort and/or catch to its average annual level and that fishing activities take place within the area assessed in their impact assessment submitted to SIOFA. 2. Member States whose vessels have not fished for more than 40 days in any given single year in the SIOFA Agreement Area up to 2016 shall ensure that vessels flying their flag limit their bottom fishing effort and/or catch and spatial distribution in accordance with their historical fishing record. TITLE III FISHING OPPORTUNITIES FOR THIRD-COUNTRY VESSELS IN UNION WATERS Article 47 Fishing vessels flying the flag of Norway and fishing vessels registered in the Faroe Islands Fishing vessels flying the flag of Norway and fishing vessels registered in the Faroe Islands shall be authorised to fish in Union waters within the TACs set out in Annex I to this Regulation and shall be subject to the conditions provided for in this Regulation and in Title III of Regulation (EU) 2017/2403. Article 48 Fishing vessels flying the flag of Venezuela Fishing vessels flying the flag of Venezuela shall be subject to the conditions provided for in this Regulation and in Title III of Regulation (EU) 2017/2403. Article 49 Fishing authorisations The maximum number of fishing authorisations for third-country vessels fishing in Union waters shall be as set out in Part B of Annex V. Article 50 Conditions for landing catches and by-catches The conditions specified in Article 7 shall apply to catches and by-catches of third-country vessels fishing under the authorisations referred to in Article 49. Article 51 Closed fishing seasons Third-country vessels authorised to fish for sandeel and associated by-catches in Union waters of ICES subarea 4 shall not fish for sandeel in that area with demersal trawl, seine or similar towed gear with a mesh size of less than 16 mm from 1 January to 31 March 2020 and from 1 August to 31 December 2020. Article 52 Prohibited species 1. It shall be prohibited for third-country vessels to fish for, to retain on board, to tranship or to land the following species whenever they are found in Union waters: (a) starry ray (Amblyraja radiata) in Union waters of ICES divisions 2a, 3a and 7d and ICES subarea 4; (b) common skate (Dipturus batis) complex (Dipturus cf. flossada and Dipturus cf. intermedia) in Union waters of ICES division 2a and ICES subareas 3, 4, 6, 7, 8, 9 and 10; (c) tope shark (Galeorhinus galeus) when taken with longlines in Union waters of ICES division 2a and ICES subareas 1, 4, 5, 6, 7, 8, 12 and 14; (d) kitefin shark (Dalatias licha), birdbeak dogfish (Deania calcea), leafscale gulper shark (Centrophorus squamosus), great lanternshark (Etmopterus princeps) and Portuguese dogfish (Centroscymnus coelolepis) in Union waters of ICES division 2a and ICES subareas 1, 4 and 14; (e) porbeagle (Lamna nasus) in Union waters; (f) thornback ray (Raja clavata) in Union waters of ICES division 3a; (g) undulate ray (Raja undulata) in Union waters of ICES subareas 6, 9 and 10; (h) common guitarfish (Rhinobatos rhinobatos) in the Mediterranean; (i) whale shark (Rhincodon typus) in all waters; (j) picked dogfish (Squalus acanthias) in Union waters of ICES subareas 2, 3, 4, 5, 6, 7, 8, 9 and 10. 2. When accidentally caught, the species referred to in paragraph 1 shall not be harmed. Specimens shall be promptly released. TITLE IV FINAL PROVISIONS Article 53 Committee procedure 1. The Commission shall be assisted by the Committee for Fisheries and Aquaculture established by Regulation (EU) No 1380/2013. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 54 Transitional provision Article 10, Article 12(2), Articles 16, 22, 23, 28, 36, 37, 38, 43, 45 and 52 shall continue to apply, mutatis mutandis, in 2021 until the entry into force of the Regulation fixing the fishing opportunities for 2021. Article 55 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2020. However, Article 9 shall apply from 1 February 2020. The provisions on fishing opportunities set out in Articles 23, 24 and 25 and Annex VII for certain stocks in the CCAMLR Convention Area shall apply from 1 December 2019. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 January 2020. For the Council The President M. VU\u010cKOVI\u0106 (1) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (2) Regulation (EU) 2019/472 of the European Parliament and of the Council of 19 March 2019 establishing a multiannual plan for stocks fished in the Western Waters and adjacent waters, and for fisheries exploiting those stocks, amending Regulations (EU) 2016/1139 and (EU) 2018/973, and repealing Council Regulations (EC) No 811/2004, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007 and (EC) No 1300/2008 (OJ L 83, 25.3.2019, p. 1). (3) Council Regulation (EC) No 1100/2007 of 18 September 2007 establishing measures for the recovery of the stock of European eel (OJ L 248, 22.9.2007, p. 17). (4) Regulation (EU) 2018/973 of the European Parliament and of the Council of 4 July 2018 establishing a multiannual plan for demersal stocks in the North Sea and the fisheries exploiting those stocks, specifying details of the implementation of the landing obligation in the North Sea and repealing Council Regulations (EC) No 676/2007 and (EC) No 1342/2008 (OJ L 179, 16.7.2018, p. 1). (5) Regulation (EU) 2016/1627 of the European Parliament and of the Council of 14 September 2016 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, and repealing Council Regulation (EC) No 302/2009 (OJ L 252, 16.9.2016, p. 1). (6) Council Regulation (EC) No 847/96 of 6 May 1996 introducing additional conditions for year-to-year management of TACs and quotas (OJ L 115, 9.5.1996, p. 3). (7) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (8) Agreement on fisheries between the European Economic Community and the Kingdom of Norway (OJ L 226, 29.8.1980, p. 48). (9) Agreement on fisheries between the European Economic Community, of the one part, and the Government of Denmark and the Home Government of the Faeroe Islands, of the other part (OJ L 226, 29.8.1980, p. 12). (10) Fisheries Partnership Agreement between the European Community on the one hand, and the Government of Denmark and the Home Rule Government of Greenland, on the other hand (OJ L 172, 30.6.2007, p. 4) and Protocol setting out the fishing opportunities and financial contribution provided for in that Agreement (OJ L 293, 23.10.2012, p. 5). (11) Council Decision (EU) 2015/1565 of 14 September 2015 on the approval, on behalf of the European Union, of the Declaration on the granting of fishing opportunities in EU waters to fishing vessels flying the flag of the Bolivarian Republic of Venezuela in the exclusive economic zone off the coast of French Guiana (OJ L 244, 19.9.2015, p. 55). (12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (13) Regulation (EU) 2019/1241 of the European Parliament and of the Council of 20 June 2019 on the conservation of fisheries resources and the protection of marine ecosystems through technical measures, amending Council Regulations (EC) No 1967/2006, (EC) No 1224/2009 and Regulations (EU) No 1380/2013, (EU) 2016/1139, (EU) 2018/973, (EU) 2019/472 and (EU) 2019/1022 of the European Parliament and of the Council, and repealing Council Regulations (EC) No 894/97, (EC) No 850/98, (EC) No 2549/2000, (EC) No 254/2002, (EC) No 812/2004 and (EC) No 2187/2005 (OJ L 198, 25.7.2019, p. 105). (14) Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (OJ L 87, 31.3.2009, p. 70). (15) Council Regulation (EC) No 601/2004 of 22 March 2004 laying down certain control measures applicable to fishing activities in the area covered by the Convention on the conservation of Antarctic marine living resources and repealing Regulations (EEC) No 3943/90, (EC) No 66/98 and (EC) No 1721/1999 (OJ L 97, 1.4.2004, p. 16). (16) Regulation (EC) No 216/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in certain areas other than those of the North Atlantic (OJ L 87, 31.3.2009, p. 1). (17) Concluded by Council Decision 2006/539/EC of 22 May 2006 on the conclusion, on behalf of the European Community of the Convention for the Strengthening of the Inter-American Tropical Tuna Commission established by the 1949 Convention between the United States of America and the Republic of Costa Rica (OJ L 224, 16.8.2006, p. 22). (18) The Union acceded by Council Decision 86/238/EEC of 9 June 1986 on the accession of the Community to the International Convention for the Conservation of Atlantic Tunas, as amended by the Protocol annexed to the Final Act of the Conference of Plenipotentiaries of the States Parties to the Convention signed in Paris on 10 July 1984 (OJ L 162, 18.6.1986, p. 33). (19) The Union acceded by Council Decision 95/399/EC of 18 September 1995 on the accession of the Community to the Agreement for the establishment of the Indian Ocean Tuna Commission (OJ L 236, 5.10.1995, p. 24). (20) Regulation (EC) No 217/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of catch and activity statistics by Member States fishing in the north-west Atlantic (OJ L 87, 31.3.2009, p. 42). (21) Concluded by Council Decision 2002/738/EC of 22 July 2002 on the conclusion by the European Community of the Convention on the Conservation and Management of Fishery Resources in the South-East Atlantic Ocean (OJ L 234, 31.8.2002, p. 39). (22) The Union acceded by Council Decision 2008/780/EC of 29 September 2008 on the conclusion, on behalf of the European Community, of the Southern Indian Ocean Fisheries Agreement (OJ L 268, 9.10.2008, p. 27). (23) The Union acceded by Council Decision 2012/130/EU of 3 October 2011 on the approval, on behalf of the European Union, of the Convention on the Conservation and Management of High Seas Fishery Resources in the South Pacific Ocean (OJ L 67, 6.3.2012, p. 1). (24) The Union acceded by Council Decision 2005/75/EC of 26 April 2004 on the accession of the Community to the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (OJ L 32, 4.2.2005, p. 1). (25) Regulation (EU) 2017/2403 of the European Parliament and of the Council of 12 December 2017 on the sustainable management of external fishing fleets, and repealing Council Regulation (EC) No 1006/2008 (OJ L 347, 28.12.2017, p. 81). (26) All types of demersal trawls (OTB, OTT, PTB, TBB, TBN, TBS and TB). (27) All types of seines (SSC, SDN, SPR, SV, SB and SX). (28) All long lines or pole and line or rod and line fisheries (LHP, LHM, LLD, LL, LTL, LX and LLS). (29) All fixed gillnets and traps (GTR, GNS, GNC, FYK, FPN and FIX). (30) Commission Delegated Regulation (EU) 2018/2034 of 18 October 2018 establishing a discard plan for certain demersal fisheries in North-Western waters for the period 2019-2021 (OJ L 327, 21.12.2018, p. 8). (31) Council Regulation (EC) No 520/2007 of 7 May 2007 laying down technical measures for the conservation of certain stocks of highly migratory species and repealing Regulation (EC) No 973/2001 (OJ L 123, 12.5.2007, p. 3). LIST OF ANNEXES ANNEX I: TACs applicable to Union fishing vessels in areas where TACs exist by species and by area ANNEX IA: Skagerrak, Kattegat, ICES subareas 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 14, Union waters of CECAF, French Guiana waters ANNEX IB: North East Atlantic and Greenland, ICES subareas 1, 2, 5, 12 and 14 and Greenland waters of NAFO 1 ANNEX IC: North West Atlantic \u2013 NAFO Convention Area ANNEX ID: ICCAT Convention Area ANNEX IE: South-East Atlantic Ocean \u2013 SEAFO Convention Area ANNEX IF: Southern bluefin tuna \u2013 areas of distribution ANNEX IG: WCPFC Convention Area ANNEX IH: SPRFMO Convention Area ANNEX IJ: IOTC Area of Competence ANNEX IK: SIOFA Agreement Area ANNEX IL: IATTC Convention Area ANNEX II: Fishing effort for vessels in the context of the management of Western Channel sole stocks in ICES division 7e ANNEX III: Management areas for sandeel in ICES divisions 2a, 3a and ICES subarea 4 ANNEX IV: Seasonal closures to protect spawning cod ANNEX V: Fishing authorisations ANNEX VI: ICCAT Convention Area ANNEX VII: CCAMLR Convention Area ANNEX VIII: IOTC Area of Competence ANNEX IX: WCPFC Convention Area ANNEX I TACs APPLICABLE TO UNION FISHING VESSELS IN AREAS WHERE TACs EXIST BY SPECIES AND BY AREA The tables in this Annex set out the TACs and quotas (in tonnes live weight, except where otherwise specified) by stock, and, where appropriate, the conditions functionally linked thereto. All fishing opportunities set out in this Annex shall be subject to the rules set out in Regulation (EC) No 1224/2009, and in particular Articles 33 and 34 of that Regulation. The references to fishing zones are references to ICES zones, unless otherwise specified. Within each area, fish stocks are referred to according to the alphabetical order of the Latin names of the species. Only Latin names identify species for regulatory purposes; vernacular names are provided for ease of reference. For the purposes of this Regulation, the following comparative table of Latin names and common names is provided: Scientific name Alpha-3 code Common name Amblyraja radiata RJR Starry ray Ammodytes spp. SAN Sandeels Argentina silus ARU Greater silver smelt Beryx spp. ALF Alfonsinos Brosme brosme USK Tusk Caproidae BOR Boarfish Centrophorus squamosus GUQ Leafscale gulper shark Centroscymnus coelolepis CYO Portuguese dogfish Chaceon spp. GER Deep sea red crab Chaenocephalus aceratus SSI Blackfin icefish Champsocephalus gunnari ANI Mackerel icefish Channichthys rhinoceratus LIC Unicorn icefish Chionoecetes spp. PCR Snow crab Clupea harengus HER Herring Coryphaenoides rupestris RNG Roundnose grenadier Dalatias licha SCK Kitefin shark Deania calcea DCA Birdbeak dogfish Dicentrarchus labrax BSS European seabass Dipturus batis (Dipturus cf. flossada and Dipturus cf. intermedia) RJB Common skate complex Dissostichus eleginoides TOP Patagonian toothfish Dissostichus mawsoni TOA Antarctic toothfish Dissostichus spp. TOT Toothfish Engraulis encrasicolus ANE Anchovy Etmopterus princeps ETR Great lanternshark Etmopterus pusillus ETP Smooth lanternshark Euphausia superba KRI Krill Gadus morhua COD Cod Galeorhinus galeus GAG Tope shark Glyptocephalus cynoglossus WIT Witch flounder Hippoglossoides platessoides PLA American plaice Hoplostethus atlanticus ORY Orange roughy Illex illecebrosus SQI Shortfin squid Lamna nasus POR Porbeagle Lepidorhombus spp. LEZ Megrims Leucoraja naevus RJN Cuckoo ray Limanda ferruginea YEL Yellowtail flounder Lophiidae ANF Anglerfish Macrourus spp. GRV Grenadiers Makaira nigricans BUM Blue marlin Mallotus villosus CAP Capelin Manta birostris RMB Giant manta ray Martialia hyadesi SQS Squid Melanogrammus aeglefinus HAD Haddock Merlangius merlangus WHG Whiting Merluccius merluccius HKE Hake Micromesistius poutassou WHB Blue whiting Microstomus kitt LEM Lemon sole Molva dypterygia BLI Blue ling Molva molva LIN Ling Nephrops norvegicus NEP Norway lobster Notothenia gibberifrons NOG Humped rockcod Notothenia rossii NOR Marbled rockcod Notothenia squamifrons NOS Grey rockcod Pandalus borealis PRA Northern prawn Paralomis spp. PAI Crabs Penaeus spp. PEN \u2018Penaeus\u2019 shrimps Pleuronectes platessa PLE Plaice Pleuronectiformes FLX Flatfish Pollachius pollachius POL Pollack Pollachius virens POK Saithe Psetta maxima TUR Turbot Pseudochaenichthys georgianus SGI South Georgia icefish Pseudopentaceros spp. EDW Pelagic armourhead Raja alba RJA White skate Raja brachyura RJH Blonde ray Raja circularis RJI Sandy ray Raja clavata RJC Thornback ray Raja fullonica RJF Shagreen ray Raja (Dipturus) nidarosiensis JAD Norwegian skate Raja microocellata RJE Small-eyed ray Raja montagui RJM Spotted ray Raja undulata RJU Undulate ray Rajiformes SRX Skates and rays Reinhardtius hippoglossoides GHL Greenland halibut Sardina pilchardus PIL Sardine Scomber scombrus MAC Mackerel Scophthalmus rhombus BLL Brill Sebastes spp. RED Redfish Solea solea SOL Common sole Solea spp. SOO Sole Sprattus sprattus SPR Sprat Squalus acanthias DGS Picked dogfish Tetrapturus albidus WHM White marlin Thunnus maccoyii SBF Southern bluefin tuna Thunnus obesus BET Bigeye tuna Thunnus thynnus BFT Bluefin tuna Trachurus murphyi CJM Jack mackerel Trachurus spp. JAX Horse mackerel Trisopterus esmarkii NOP Norway pout Urophycis tenuis HKW White hake Xiphias gladius SWO Swordfish The following comparative table of common names and Latin names is provided exclusively for explanatory purposes: Common name Alpha-3 code Scientific name Alfonsinos ALF Beryx spp. American plaice PLA Hippoglossoides platessoides Anchovy ANE Engraulis encrasicolus Anglerfish ANF Lophiidae Antarctic toothfish TOA Dissostichus mawsoni Bigeye tuna BET Thunnus obesus Birdbeak dogfish DCA Deania calcea Blackfin icefish SSI Chaenocephalus aceratus Blonde ray RJH Raja brachyura Blue ling BLI Molva dypterygia Blue marlin BUM Makaira nigricans Blue whiting WHB Micromesistius poutassou Bluefin tuna BFT Thunnus thynnus Boarfish BOR Caproidae Brill BLL Scophthalmus rhombus Capelin CAP Mallotus villosus Cod COD Gadus morhua Common skate complex RJB Dipturus batis (Dipturus cf. flossada and Dipturus cf. intermedia) Common sole SOL Solea solea Crabs PAI Paralomis spp. Cuckoo ray RJN Leucoraja naevus Deep sea red crab GER Chaceon spp. European seabass BSS Dicentrarchus labrax Flatfish FLX Pleuronectiformes Giant manta ray RMB Manta birostris Great lanternshark ETR Etmopterus princeps Greater silver smelt ARU Argentina silus Greenland halibut GHL Reinhardtius hippoglossoides Grenadiers GRV Macrourus spp. Grey rockcod NOS Notothenia squamifrons Haddock HAD Melanogrammus aeglefinus Hake HKE Merluccius merluccius Herring HER Clupea harengus Horse mackerel JAX Trachurus spp. Humped rockcod NOG Notothenia gibberifrons Jack mackerel CJM Trachurus murphyi Kitefin shark SCK Dalatias licha Krill KRI Euphausia superba Leafscale gulper shark GUQ Centrophorus squamosus Lemon sole LEM Microstomus kitt Ling LIN Molva molva Mackerel MAC Scomber scombrus Mackerel icefish ANI Champsocephalus gunnari Marbled rockcod NOR Notothenia rossii Megrims LEZ Lepidorhombus spp. Northern prawn PRA Pandalus borealis Norway lobster NEP Nephrops norvegicus Norway pout NOP Trisopterus esmarkii Norwegian skate JAD Raja (Dipturus) nidarosiensis Orange roughy ORY Hoplostethus atlanticus Patagonian toothfish TOP Dissostichus eleginoides Pelagic armourhead EDW Pseudopentaceros spp. \u2018Penaeus\u2019 shrimps PEN Penaeus spp. Picked dogfish DGS Squalus acanthias Plaice PLE Pleuronectes platessa Pollack POL Pollachius pollachius Porbeagle POR Lamna nasus Portuguese dogfish CYO Centroscymnus coelolepis Redfish RED Sebastes spp. Roundnose grenadier RNG Coryphaenoides rupestris Saithe POK Pollachius virens Sandeels SAN Ammodytes spp. Sandy ray RJI Raja circularis Sardine PIL Sardina pilchardus Shagreen ray RJF Raja fullonica Shortfin squid SQI Illex illecebrosus Skates and rays SRX Rajiformes Small-eyed ray RJE Raja microocellata Smooth lanternshark ETP Etmopterus pusillus Snow crab PCR Chionoecetes spp. Sole SOO Solea spp. South Georgia icefish SGI Pseudochaenichthys georgianus Southern bluefin tuna SBF Thunnus maccoyii Spotted ray RJM Raja montagui Sprat SPR Sprattus sprattus Squid SQS Martialia hyadesi Starry ray RJR Amblyraja radiata Swordfish SWO Xiphias gladius Thornback ray RJC Raja clavata Toothfish TOT Dissostichus spp. Tope shark GAG Galeorhinus galeus Turbot TUR Psetta maxima Tusk USK Brosme brosme Undulate ray RJU Raja undulata Unicorn icefish LIC Channichthys rhinoceratus White hake HKW Urophycis tenuis White marlin WHM Tetrapturus albidus White skate RJA Raja alba Whiting WHG Merlangius merlangus Witch flounder WIT Glyptocephalus cynoglossus Yellowtail flounder YEL Limanda ferruginea ANNEX IA SKAGERRAK, KATTEGAT, ICES SUBAREAS 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 AND 14, UNION WATERS OF CECAF, FRENCH GUIANA WATERS Species: Sandeel and associated by-catches Ammodytes spp. Zone: Union waters of 2a, 3a and 4 (1) Denmark 0 (2) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply United Kingdom 0 (2) Germany 0 (2) Sweden 0 (2) Union 0 TAC 0 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following sandeel management areas, as defined in Annex III: Zone: Union waters of sandeel management areas 1r 2r () 3r 4 () 5r 6 7r (SAN/234_1R) (SAN/234_2R) (SAN/234_3R) (SAN/234_4) (SAN/234_5R) (SAN/234_6) (SAN/234_7R) Denmark 0 0 0 0 0 0 0 United Kingdom 0 0 0 0 0 0 0 Germany 0 0 0 0 0 0 0 Sweden 0 0 0 0 0 0 0 Union 0 0 0 0 0 0 0 Total 0 0 0 0 0 0 0 () In management areas 2r and 4 the TAC may only be fished as a monitoring TAC with an associated sampling protocol for the fishery. Species: Greater silver smelt Argentina silus Zone: Union and international waters of 1 and 2 (ARU/1/2.) Germany 24 Precautionary TAC France 8 The Netherlands 19 United Kingdom 39 Union 90 TAC 90 Species: Greater silver smelt Argentina silus Zone: Union waters of 3a and 4 (ARU/3A4-C) Denmark 1 093 Precautionary TAC Germany 11 France 8 Ireland 8 The Netherlands 51 Sweden 43 United Kingdom 20 Union 1 234 TAC 1 234 Species: Greater silver smelt Argentina silus Zone: Union and international waters of 5, 6 and 7 (ARU/567.) Germany 284 Precautionary TAC France 6 Ireland 263 The Netherlands 2 968 United Kingdom 208 Union 3 729 TAC 3 729 Species: Tusk Brosme brosme Zone: Union and international waters of 1, 2 and 14 (USK/1214EI) Germany 6 (4) Precautionary TAC France 6 (4) Article 7(2) of this Regulation applies United Kingdom 6 (4) Others 3 (4) Union 21 (4) TAC 21 Species: Tusk Brosme brosme Zone: 3a (USK/03A.) Denmark 15 Precautionary TAC Sweden 8 Article 7(2) of this Regulation applies Germany 8 Union 31 TAC 31 Species: Tusk Brosme brosme Zone: Union waters of 4 (USK/04-C.) Denmark 68 Precautionary TAC Germany 20 Article 7(2) of this Regulation applies France 47 Sweden 7 United Kingdom 102 Others 7 (5) Union 251 TAC 251 Species: Tusk Brosme brosme Zone: Union and international waters of 5, 6 and 7 (USK/567EI.) Germany 17 Precautionary TAC Spain 60 Article 7(2) of this Regulation applies France 705 Ireland 68 United Kingdom 340 Others 17 (6) Union 1 207 Norway 2 923 (7) (8) (9) (10) TAC 4 130 Species: Tusk Brosme brosme Zone: Norwegian waters of 4 (USK/04-N.) Belgium 0 Precautionary TAC Denmark 165 Article 3 of Regulation (EC) No 847/96 shall not apply Germany 1 Article 4 of Regulation (EC) No 847/96 shall not apply France 0 The Netherlands 0 United Kingdom 4 Union 170 TAC Not relevant Species: Boarfish Caproidae Zone: Union and international waters of 6, 7 and 8 (BOR/678-) Denmark 4 700 Precautionary TAC Ireland 13 235 United Kingdom 1 217 Union 19 152 TAC 19 152 Species: Herring (11) Clupea harengus Zone: 3a (HER/03A.) Denmark 10 309 (12) Analytical TAC Germany 165 (12) Article 7(2) of this Regulation applies Sweden 10 783 (12) Union 21 257 (12) Norway 3 271 TAC 24 528 Species: Herring (13) Clupea harengus Zone: Union and Norwegian waters of 4 north of 53\u00b0 30' N (HER/4AB.) Denmark 59 468 Analytical TAC Germany 39 404 Article 7(2) of this Regulation applies France 20 670 The Netherlands 51 717 Sweden 3 913 United Kingdom 55 583 Union 230 755 Faroe Islands 250 Norway 111 652 (14) TAC 385 008 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zone: Norwegian waters south of 62\u00b0 N (HER/*04N-) () Union 50 000 () Catches of herring taken in fisheries using nets with mesh sizes equal to or larger than 32 mm. Species: Herring Clupea harengus Zone: Norwegian waters south of 62\u00b0 N (HER/04-N.) Sweden 948 (16) Analytical TAC Union 948 Article 3 of Regulation (EC) No 847/96 shall not apply TAC 385 008 Article 4 of Regulation (EC) No 847/96 shall not apply Species: Herring (17) Clupea harengus Zone: 3a (HER/03A-BC) Denmark 5 692 Analytical TAC Germany 51 Article 7(2) of this Regulation applies Sweden 916 Union 6 659 TAC 6 659 Species: Herring (18) Clupea harengus Zone: 4, 7d and Union waters of 2a (HER/2A47DX) Belgium 44 Analytical TAC Denmark 8 573 Article 7(2) of this Regulation applies Germany 44 France 44 The Netherlands 44 Sweden 42 United Kingdom 163 Union 8 954 TAC 8 954 Species: Herring (19) Clupea harengus Zone: 4c, 7d (20) (HER/4CXB7D) Belgium 8 632 (21) Analytical TAC Denmark 800 (21) Article 7(2) of this Regulation applies Germany 530 (21) France 10 277 (21) The Netherlands 18 162 (21) United Kingdom 3 950 (21) Union 42 351 (21) TAC 385 008 Species: Herring Clupea harengus Zone: Union and international waters of 5b, 6b and 6aN (22) (HER/5B6ANB) Germany 389 (23) Precautionary TAC France 74 (23) Article 3 of Regulation (EC) No 847/96 shall not apply Ireland 526 (23) Article 4 of Regulation (EC) No 847/96 shall not apply The Netherlands 389 (23) United Kingdom 2 102 (23) Union 3 480 (23) TAC 3 480 Species: Herring Clupea harengus Zone: 6aS (24), 7b, 7c (HER/6AS7BC) Ireland 1 236 Precautionary TAC The Netherlands 124 Article 3 of Regulation (EC) No 847/96 shall not apply Union 1 360 Article 4 of Regulation (EC) No 847/96 shall not apply TAC 1 360 Species: Herring Clupea harengus Zone: 6 Clyde (25) (HER/06ACL.) United Kingdom To be established Precautionary TAC Union To be established (26) Article 6 of this Regulation applies. TAC To be established (26) Species: Herring Clupea harengus Zone: 7a (27) (HER/07A/MM) Ireland 2 099 Analytical TAC United Kingdom 5 965 Article 7(2) of this Regulation applies Union 8 064 TAC 8 064 Species: Herring Clupea harengus Zone: 7e and 7f (HER/7EF.) France 465 Precautionary TAC United Kingdom 465 Union 930 TAC 930 Species: Herring Clupea harengus Zone: 7g (28), 7h (28), 7j (28) and 7k (28) (HER/7G-K.) Germany 10 (29) Analytical TAC France 54 (29) Ireland 750 (29) The Netherlands 54 (29) United Kingdom 1 (29) Union 869 (29) TAC 869 (29) Species: Anchovy Engraulis encrasicolus Zone: 8 (ANE/08.) Spain 28 703 Analytical TAC France 3 189 Union 31 892 TAC 31 892 Species: Anchovy Engraulis encrasicolus Zone: 9 and 10; Union waters of CECAF 34.1.1 (ANE/9/3411) Spain 0 (30) Precautionary TAC Portugal 0 (30) Union 0 (30) TAC 0 (30) Species: Cod Gadus morhua Zone: Skagerrak (COD/03AN.) Belgium 5 Analytical TAC Denmark 1 683 Germany 42 The Netherlands 11 Sweden 294 Union 2 035 TAC 2 103 Species: Cod Gadus morhua Zone: Kattegat (COD/03AS.) Denmark 80 (31) Precautionary TAC Germany 2 (31) Article 3 of Regulation (EC) No 847/96 shall not apply Sweden 48 (31) Article 4 of Regulation (EC) No 847/96 shall not apply Union 130 (31) TAC 130 (31) Species: Cod Gadus morhua Zone: 4; Union waters of 2a; that part of 3a not covered by the Skagerrak and Kattegat (COD/2A3AX4) Belgium 435 (32) Analytical TAC Denmark 2 499 Germany 1 584 France 537 (32) The Netherlands 1 412 (32) Sweden 17 United Kingdom 5 732 (32) Union 12 216 Norway 2 502 (33) TAC 14 718 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zone: Norwegian waters of 4 (COD/*04N-) Union 10 618 Species: Cod Gadus morhua Zone: Norwegian waters south of 62\u00b0 N (COD/04-N.) Sweden 382 (34) Analytical TAC Union 382 Article 3 of Regulation (EC) No 847/96 shall not apply TAC Not relevant Article 4 of Regulation (EC) No 847/96 shall not apply Species: Cod Gadus morhua Zone: 6b; Union and international waters of 5b west of 12\u00b000' W and of 12 and 14 (COD/5W6-14) Belgium 0 Precautionary TAC Germany 1 France 12 Ireland 16 United Kingdom 45 Union 74 TAC 74 Species: Cod Gadus morhua Zone: 6a; Union and international waters of 5b east of 12\u00b000' W (COD/5BE6A) Belgium 2 (35) Analytical TAC Germany 19 (35) Article 8 of this Regulation applies France 203 (35) Article 3 of Regulation (EC) No 847/96 shall not apply Ireland 284 (35) Article 4 of Regulation (EC) No 847/96 shall not apply United Kingdom 771 (35) Union 1 279 (35) TAC 1 279 (35) Species: Cod Gadus morhua Zone: 7a (COD/07A.) Belgium 3 (36) Precautionary TAC France 9 (36) Ireland 170 (36) The Netherlands 1 (36) United Kingdom 74 (36) Union 257 (36) TAC 257 (36) Species: Cod Gadus morhua Zone: 7b, 7c, 7e-k, 8, 9 and 10; Union waters of CECAF 34.1.1 (COD/7XAD34) Belgium 18 (37) Analytical TAC France 294 (37) Article 8 of this Regulation applies Ireland 461 (37) Article 3 of Regulation (EC) No 847/96 shall not apply The Netherlands 0 (37) Article 4 of Regulation (EC) No 847/96 shall not apply United Kingdom 32 (37) Union 805 (37) TAC 805 (37) Species: Cod Gadus morhua Zone: 7d (COD/07D.) Belgium 37 (38) Analytical TAC France 721 (38) The Netherlands 21 (38) United Kingdom 79 (38) Union 858 (38) TAC 858 Species: Megrims Lepidorhombus spp. Zone: Union waters of 2a and 4 (LEZ/2AC4-C) Belgium 9 Analytical TAC Denmark 8 Article 7(2) of this Regulation applies Germany 8 France 48 The Netherlands 38 United Kingdom 2 811 Union 2 922 TAC 2 922 Species: Megrims Lepidorhombus spp. Zone: Union and international waters of 5b; 6; international waters of 12 and 14 (LEZ/56-14) Spain 671 Analytical TAC France 2 615 (39) Article 7(2) of this Regulation applies Ireland 764 United Kingdom 1 851 (39) Union 5 901 TAC 5 901 Species: Megrims Lepidorhombus spp. Zone: 7 (LEZ/07.) Belgium 506 (40) Analytical TAC Spain 5 620 (41) Article 7(2) of this Regulation applies France 6 820 (41) Ireland 3 101 (41) United Kingdom 2 685 (41) Union 18 732 TAC 18 732 Species: Megrims Lepidorhombus spp. Zone: 8a, 8b, 8d and 8e (LEZ/8ABDE.) Spain 993 Analytical TAC France 801 Article 7(2) of this Regulation applies Union 1 794 TAC 1 794 Species: Megrims Lepidorhombus spp. Zone: 8c, 9 and 10; Union waters of CECAF 34.1.1 (LEZ/8C3411) Spain 2 144 Analytical TAC France 107 Article 7(2) of this Regulation applies Portugal 71 Union 2 322 TAC 2 322 Species: Anglerfish Lophiidae Zone: Union waters of 2a and 4 (ANF/2AC4-C) Belgium 498 (42) Precautionary TAC Denmark 1 098 (42) Germany 536 (42) France 102 (42) The Netherlands 377 (42) Sweden 13 (42) United Kingdom 11 461 (42) Union 14 085 (42) TAC 14 085 Species: Anglerfish Lophiidae Zone: Norwegian waters of 4 (ANF/04-N.) Belgium 51 Precautionary TAC Denmark 1 305 Article 3 of Regulation (EC) No 847/96 shall not apply Germany 21 Article 4 of Regulation (EC) No 847/96 shall not apply The Netherlands 18 United Kingdom 305 Union 1 700 TAC Not relevant Species: Anglerfish Lophiidae Zone: 6; Union and international waters of 5b; international waters of 12 and 14 (ANF/56-14) Belgium 286 (43) Precautionary TAC Germany 327 (43) Spain 307 France 3 525 (43) Ireland 797 The Netherlands 276 (43) United Kingdom 2 453 (43) Union 7 971 TAC 7 971 Species: Anglerfish Lophiidae Zone: 7 (ANF/07.) Belgium 3 262 (44) Analytical TAC Germany 364 (44) Article 7(2) of this Regulation applies Spain 1 296 (44) France 20 932 (44) Ireland 2 675 (44) The Netherlands 422 (44) United Kingdom 6 348 (44) Union 35 299 (44) TAC 35 299 Species: Anglerfish Lophiidae Zone: 8a, 8b, 8d and 8e (ANF/8ABDE.) Spain 1 372 Analytical TAC France 7 636 Article 7(2) of this Regulation applies Union 9 008 TAC 9 008 Species: Anglerfish Lophiidae Zone: 8c, 9 and 10; Union waters of CECAF 34.1.1 (ANF/8C3411) Spain 3 353 Analytical TAC France 3 Article 7(2) of this Regulation applies Portugal 667 Union 4 023 TAC 4 023 Species: Haddock Melanogrammus aeglefinus Zone: 3a (HAD/03A.) Belgium 10 Analytical TAC Denmark 1 768 Article 7(2) of this Regulation applies Germany 112 The Netherlands 2 Sweden 209 Union 2 101 TAC 2 193 Species: Haddock Melanogrammus aeglefinus Zone: 4; Union waters of 2a (HAD/2AC4.) Belgium 206 Analytical TAC Denmark 1 416 Article 7(2) of this Regulation applies Germany 901 France 1 571 The Netherlands 155 Sweden 143 United Kingdom 23 361 Union 27 753 Norway 7 900 TAC 35 653 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zones: Norwegian waters of 4 (HAD/*04N-) Union 20 644 Species: Haddock Melanogrammus aeglefinus Zone: Norwegian waters south of 62\u00b0 N (HAD/04-N.) Sweden 707 (45) Analytical TAC Union 707 Article 3 of Regulation (EC) No 847/96 shall not apply TAC Not relevant Article 4 of Regulation (EC) No 847/96 shall not apply Species: Haddock Melanogrammus aeglefinus Zone: Union and international waters of 6b, 12 and 14 (HAD/6B1214) Belgium 23 Analytical TAC Germany 28 Article 7(2) of this Regulation applies France 1 155 Ireland 824 United Kingdom 8 442 Union 10 472 TAC 10 472 Species: Haddock Melanogrammus aeglefinus Zone: Union and international waters of 5b and 6a (HAD/5BC6A.) Belgium 4 (46) Analytical TAC Germany 5 (46) Article 7(2) of this Regulation applies France 219 (46) Ireland 651 (46) United Kingdom 3 094 (46) Union 3 973 TAC 3 973 Species: Haddock Melanogrammus aeglefinus Zone: 7b-k, 8, 9 and 10; Union waters of CECAF 34.1.1 (HAD/7X7A34) Belgium 121 Analytical TAC France 7 239 Article 7(2) of this Regulation applies Ireland 2 413 United Kingdom 1 086 Union 10 859 TAC 10 859 Species: Haddock Melanogrammus aeglefinus Zone: 7a (HAD/07A.) Belgium 50 Analytical TAC France 228 Article 7(2) of this Regulation applies Ireland 1 366 United Kingdom 1 512 Union 3 156 TAC 3 156 Species: Whiting Merlangius merlangus Zone: 3a (WHG/03A.) Denmark 1 166 Precautionary TAC The Netherlands 4 Sweden 125 Union 1 295 TAC 1 660 Species: Whiting Merlangius merlangus Zone: 4; Union waters of 2a (WHG/2AC4.) Belgium 329 Analytical TAC Denmark 1 424 Article 7(2) of this Regulation applies Germany 370 France 2 140 The Netherlands 823 Sweden 3 United Kingdom 10 293 Union 15 382 Norway 1 216 (47) TAC 17 158 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zones: Norwegian waters of 4 (WHG/*04N-) Union 10 801 Species: Whiting Merlangius merlangus Zone: 6; Union and international waters of 5b; international waters of 12 and 14 (WHG/56-14) Germany 3 (48) Analytical TAC France 57 (48) Article 8 of this Regulation applies Ireland 273 (48) Article 3 of Regulation (EC) No 847/96 shall not apply United Kingdom 604 (48) Article 4 of Regulation (EC) No 847/96 shall not apply Union 937 (48) TAC 937 (48) Species: Whiting Merlangius merlangus Zone: 7a (WHG/07A.) Belgium 2 (49) Analytical TAC France 25 (49) Article 8 of this Regulation applies Ireland 415 (49) Article 3 of Regulation (EC) No 847/96 shall not apply The Netherlands 0 (48) Article 4 of Regulation (EC) No 847/96 shall not apply United Kingdom 279 (49) Union 721 (49) TAC 721 (49) Species: Whiting Merlangius merlangus Zone: 7b, 7c, 7d, 7e, 7f, 7g, 7h, 7j and 7k (WHG/7X7A-C) Belgium 92 Analytical TAC France 5 644 Ireland 4 072 The Netherlands 46 United Kingdom 1 009 Union 10 863 TAC 10 863 Species: Whiting Merlangius merlangus Zone: 8 (WHG/08.) Spain 1 016 Precautionary TAC France 1 524 Union 2 540 TAC 2 540 Species: Whiting and pollack Merlangius merlangus and Pollachius pollachius Zone: Norwegian waters south of 62\u00b0 N (W/P/04-N.) Sweden 190 (50) Precautionary TAC Union 190 TAC Not relevant Species: Hake Merluccius merluccius Zone: 3a (HKE/03A.) Denmark 3 136 (51) Analytical TAC Sweden 267 (51) Article 7(2) of this Regulation applies Union 3 403 TAC 3 403 Species: Hake Merluccius merluccius Zone: Union waters of 2a and 4 (HKE/2AC4-C) Belgium 56 (52) Analytical TAC Denmark 2 278 (52) Article 7(2) of this Regulation applies Germany 261 (52) France 504 (52) The Netherlands 131 (52) United Kingdom 710 (52) Union 3 940 (52) TAC 3 940 Species: Hake Merluccius merluccius Zone: 6 and 7; Union and international waters of 5b; international waters of 12 and 14 (HKE/571214) Belgium 582 (53) Analytical TAC Spain 18 667 Article 7(2) of this Regulation applies France 28 827 (53) Ireland 3 493 The Netherlands 376 (53) United Kingdom 11 380 (53) Union 63 325 TAC 63 325 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zones: 8a, 8b, 8d and 8e (HKE/*8ABDE) Belgium 75 Spain 3 012 France 3 012 Ireland 376 The Netherlands 38 United Kingdom 1 694 Union 8 206 Species: Hake Merluccius merluccius Zone: 8a, 8b, 8d and 8e (HKE/8ABDE.) Belgium 19 (54) Analytical TAC Spain 12 995 Article 7(2) of this Regulation applies France 29 183 The Netherlands 38 (54) Union 42 235 TAC 42 235 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zones: 6 and 7; Union and international waters of 5b; international waters of 12 and 14 (HKE/*57-14) Belgium 4 Spain 3 764 France 6 776 The Netherlands 11 Union 10 555 Species: Hake Merluccius merluccius Zone: 8c, 9 and 10; Union waters of CECAF 34.1.1 (HKE/8C3411) Spain 5 600 Analytical TAC France 538 Article 7(2) of this Regulation applies Portugal 2 614 Union 8 752 TAC 8 752 Species: Blue whiting Micromesistius poutassou Zone: Norwegian waters of 2 and 4 (WHB/24-N.) Denmark 0 Analytical TAC United Kingdom 0 Union 0 TAC Not relevant Species: Blue whiting Micromesistius poutassou Zone: Union and international waters of 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 8d, 8e, 12 and 14 (WHB/1X14) Denmark 49 845 (55) Analytical TAC Germany 19 380 (55) Article 7(2) of this Regulation applies Spain 42 258 (55) (56) France 34 688 (55) Ireland 38 599 (55) The Netherlands 60 780 (55) Portugal 3 926 (55) (56) Sweden 12 330 (55) United Kingdom 64 678 (55) Union 326 484 (55) (57) Norway 99 900 Faroe Islands 10 000 TAC Not relevant Species: Blue whiting Micromesistius poutassou Zone: 8c, 9 and 10; Union waters of CECAF 34.1.1 (WHB/8C3411) Spain 35 806 Analytical TAC Portugal 8 951 Article 7(2) of this Regulation applies Union 44 757 (58) TAC Not relevant Species: Blue whiting Micromesistius poutassou Zone: Union waters of 2, 4a, 5, 6 north of 56\u00b0 30' N and 7 west of 12\u00b0 W (WHB/24A567) Norway 190 809 (59) (60) Analytical TAC Faroe Islands 37 500 (61) (62) Article 7(2) of this Regulation applies TAC Not relevant Species: Lemon sole and witch flounder Microstomus kitt and Glyptocephalus cynoglossus Zone: Union waters of 2a and 4 (L/W/2AC4-C) Belgium 368 Precautionary TAC Denmark 1 012 Germany 130 France 277 The Netherlands 842 Sweden 11 United Kingdom 4 145 Union 6 785 TAC 6 785 Species: Blue ling Molva dypterygia Zone: Union and international waters of 5b, 6 and 7 (BLI/5B67-) Germany 113 Analytical TAC Estonia 17 Article 7(2) of this Regulation applies Spain 356 France 8 126 Ireland 31 Lithuania 7 Poland 3 United Kingdom 2 066 Others 31 (63) Union 10 750 Norway 250 (64) Faroe Islands 150 (65) TAC 11 150 Species: Blue ling Molva dypterygia Zone: International waters of 12 (BLI/12INT-) Estonia 0 (66) Precautionary TAC Spain 132 (66) France 3 (66) Lithuania 1 (66) United Kingdom 1 (66) Others 0 (66) Union 137 (66) TAC 137 (66) Species: Blue ling Molva dypterygia Zone: Union and international waters of 2 and 4 (BLI/24-) Denmark 2 Precautionary TAC Germany 2 Ireland 2 France 15 United Kingdom 9 Others 2 (67) Union 32 TAC 32 Species: Blue ling Molva dypterygia Zone: Union and international waters of 3a (BLI/03A-) Denmark 2 Precautionary TAC Germany 1 Sweden 2 Union 5 TAC 5 Species: Ling Molva molva Zone: Union and international waters of 1 and 2 (LIN/1/2.) Denmark 26 Precautionary TAC Germany 26 France 26 United Kingdom 26 Others 13 (68) Union 117 TAC 117 Species: Ling Molva molva Zone: Union waters of 3a (LIN/03A-C.) Belgium 13 Precautionary TAC Denmark 101 Germany 13 Sweden 39 United Kingdom 13 Union 179 TAC 179 Species: Ling Molva molva Zone: Union waters of 4 (LIN/04-C.) Belgium 27 (69) Precautionary TAC Denmark 424 (69) Germany 262 (69) France 236 The Netherlands 9 Sweden 18 (69) United Kingdom 3 261 (69) Union 4 237 TAC 4 237 Species: Ling Molva molva Zone: Union and international waters of 5 (LIN/05EI.) Belgium 9 Precautionary TAC Denmark 6 Germany 6 France 6 United Kingdom 6 Union 33 TAC 33 Species: Ling Molva molva Zone: Union and international waters of 6, 7, 8, 9, 10, 12 and 14 (LIN/6X14.) Belgium 46 (70) Precautionary TAC Denmark 8 (70) Germany 166 (70) Ireland 898 Spain 3 361 France 3 583 (70) Portugal 8 United Kingdom 4 126 (70) Union 12 196 Norway 8 000 (71) (72) (73) Faroe Islands 200 (74) (75) TAC 20 396 Species: Ling Molva molva Zone: Norwegian waters of 4 (LIN/04-N.) Belgium 9 Precautionary TAC Denmark 1 187 Article 3 of Regulation (EC) No 847/96 shall not apply Germany 33 Article 4 of Regulation (EC) No 847/96 shall not apply France 13 The Netherlands 2 United Kingdom 106 Union 1 350 TAC Not relevant Species: Norway lobster Nephrops norvegicus Zone: 3a (NEP/03A.) Denmark 10 093 Analytical TAC Germany 29 Sweden 3 611 Union 13 733 TAC 13 733 Species: Norway lobster Nephrops norvegicus Zone: Union waters of 2a and 4 (NEP/2AC4-C) Belgium 1 203 Analytical TAC Denmark 1 203 Article 7(2) of this Regulation applies Germany 18 France 35 The Netherlands 619 United Kingdom 19 924 Union 23 002 TAC 23 002 Species: Norway lobster Nephrops norvegicus Zone: Norwegian waters of 4 (NEP/04-N.) Denmark 568 Analytical TAC Germany 0 Article 3 of Regulation (EC) No 847/96 shall not apply United Kingdom 32 Article 4 of Regulation (EC) No 847/96 shall not apply Union 600 TAC Not relevant Species: Norway lobster Nephrops norvegicus Zone: 6; Union and international waters of 5b (NEP/5BC6.) Spain 32 Analytical TAC France 129 Ireland 215 United Kingdom 15 523 Union 15 899 TAC 15 899 Species: Norway lobster Nephrops norvegicus Zone: 7 (NEP/07.) Spain 1 009 (76) Analytical TAC France 4 089 (76) Ireland 6 201 (76) United Kingdom 5 516 (76) Union 16 815 (76) TAC 16 815 (76) Species: Norway lobster Nephrops norvegicus Zone: 8a, 8b, 8d and 8e (NEP/8ABDE.) Spain 233 Analytical TAC France 3 653 Union 3 886 TAC 3 886 Species: Norway lobster Nephrops norvegicus Zone: 8c (NEP/08C.) Spain 2,7 (77) Precautionary TAC France 0,0 (77) Union 2,7 (77) TAC 2,7 (77) Species: Norway lobster Nephrops norvegicus Zone: 9 and 10; Union waters of CECAF 34.1.1 (NEP/9/3411) Spain 97 (78) Precautionary TAC Portugal 289 (78) Union 386 (78) (79) TAC 386 (78) (79) Species: Northern prawn Pandalus borealis Zone: 3a (PRA/03A.) Denmark 1 537 Analytical TAC Sweden 828 Union 2 365 TAC 4 430 Species: Northern prawn Pandalus borealis Zone: Union waters of 2a and 4 (PRA/2AC4-C) Denmark 892 Precautionary TAC The Netherlands 8 Sweden 36 United Kingdom 264 Union 1 200 TAC 1 200 Species: Northern prawn Pandalus borealis Zone: Norwegian waters south of 62\u00b0 N (PRA/04-N.) Denmark 200 Analytical TAC Sweden 123 (80) Article 3 of Regulation (EC) No 847/96 shall not apply Union 323 Article 4 of Regulation (EC) No 847/96 shall not apply TAC Not relevant Species: \u2018Penaeus\u2019 shrimps Penaeus spp. Zone: French Guiana waters (PEN/FGU.) France to be established (81) Precautionary TAC Union to be established (81) (82) Article 6 of this Regulation applies TAC to be established (81) (82) Species: Plaice Pleuronectes platessa Zone: Skagerrak (PLE/03AN.) Belgium 102 Analytical TAC Denmark 13 231 Article 7(2) of this Regulation applies Germany 68 The Netherlands 2 545 Sweden 709 Union 16 655 TAC 19 647 Species: Plaice Pleuronectes platessa Zone: Kattegat (PLE/03AS.) Denmark 1 016 Analytical TAC Germany 11 Article 7(2) of this Regulation applies Sweden 114 Union 1 141 TAC 1 141 Species: Plaice Pleuronectes platessa Zone: 4; Union waters of 2a; that part of 3a not covered by the Skagerrak and the Kattegat (PLE/2A3AX4) Belgium 5 522 Analytical TAC Denmark 17 946 Article 7(2) of this Regulation applies Germany 5 177 France 1 035 The Netherlands 34 510 United Kingdom 25 538 Union 89 728 Norway 10 280 (83) TAC 146 852 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zone: Norwegian waters of 4 (PLE/*04N-) Union 56 041 Species: Plaice Pleuronectes platessa Zone: 6; Union and international waters of 5b; international waters of 12 and 14 (PLE/56-14) France 9 Precautionary TAC Ireland 261 United Kingdom 388 Union 658 TAC 658 Species: Plaice Pleuronectes platessa Zone: 7a (PLE/07A.) Belgium 115 Analytical TAC France 50 Article 7(2) of this Regulation applies Ireland 1 442 The Netherlands 35 United Kingdom 1 148 Union 2 790 TAC 2 790 Species: Plaice Pleuronectes platessa Zone: 7b and 7c (PLE/7BC.) France 11 Precautionary TAC Ireland 63 Union 74 TAC 74 Species: Plaice Pleuronectes platessa Zone: 7d and 7e (PLE/7DE.) Belgium 1 498 Analytical TAC France 4 993 Article 7(2) of this Regulation applies United Kingdom 2 663 Union 9 154 TAC 9 154 Species: Plaice Pleuronectes platessa Zone: 7f and 7g (PLE/7FG.) Belgium 466 Precautionary TAC France 842 Article 7(2) of this Regulation applies Ireland 255 United Kingdom 440 Union 2 003 TAC 2 003 Species: Plaice Pleuronectes platessa Zone: 7h, 7j and 7k (PLE/7HJK.) Belgium 4 (84) Precautionary TAC France 8 (84) Article 8 of this Regulation applies Ireland 30 (84) Article 3 of Regulation (EC) No 847/96 shall not apply The Netherlands 17 (84) Article 4 of Regulation (EC) No 847/96 shall not apply United Kingdom 8 (84) Union 67 (84) TAC 67 (84) Species: Plaice Pleuronectes platessa Zone: 8, 9 and 10; Union waters of CECAF 34.1.1 (PLE/8/3411) Spain 59 Precautionary TAC France 237 Portugal 59 Union 355 TAC 355 Species: Pollack Pollachius pollachius Zone: 6; Union and international waters of 5b; international waters of 12 and 14 (POL/56-14) Spain 3 Precautionary TAC France 114 Ireland 34 United Kingdom 87 Union 238 TAC 238 Species: Pollack Pollachius pollachius Zone: 7 (POL/07.) Belgium 378 (85) Precautionary TAC Spain 23 (85) France 8 712 (85) Ireland 929 (85) United Kingdom 2 121 (85) Union 12 163 (85) TAC 12 163 Species: Pollack Pollachius pollachius Zone: 8a, 8b, 8d and 8e (POL/8ABDE.) Spain 252 Precautionary TAC France 1 230 Union 1 482 TAC 1 482 Species: Pollack Pollachius pollachius Zone: 8c (POL/08C.) Spain 187 Precautionary TAC France 21 Union 208 TAC 208 Species: Pollack Pollachius pollachius Zone: 9 and 10; Union waters of CECAF 34.1.1 (POL/9/3411) Spain 246 (86) Precautionary TAC Portugal 8 (86) (87) Union 254 (86) TAC 254 (86) Species: Saithe Pollachius virens Zone: 3a and 4; Union waters of 2a (POK/2C3A4) Belgium 28 Analytical TAC Denmark 3 292 Article 7(2) of this Regulation applies Germany 8 314 France 19 567 The Netherlands 83 Sweden 452 United Kingdom 6 374 Union 38 110 Norway 41 703 (88) TAC 79 813 Species: Saithe Pollachius virens Zone: 6; Union and international waters of 5b, 12 and 14 (POK/56-14) Germany 350 Analytical TAC France 3 479 Article 7(2) of this Regulation applies Ireland 401 United Kingdom 3 110 Union 7 340 Norway 940 (89) TAC 8 280 Species: Saithe Pollachius virens Zone: Norwegian waters south of 62\u00b0 N (POK/04-N.) Sweden 880 (90) Analytical TAC Union 880 Article 3 of Regulation (EC) No 847/96 shall not apply TAC Not relevant Species: Saithe Pollachius virens Zone: 7, 8, 9 and 10; Union waters of CECAF 34.1.1 (POK/7/3411) Belgium 6 Precautionary TAC France 1 245 Ireland 1 491 United Kingdom 434 Union 3 176 TAC 3 176 Species: Turbot and brill Psetta maxima and Scophthalmus rhombus Zone: Union waters of 2a and 4 (T/B/2AC4-C) Belgium 477 Precautionary TAC Denmark 1 018 Article 7(2) of this Regulation applies Germany 260 France 123 The Netherlands 3 609 Sweden 7 United Kingdom 1 004 Union 6 498 TAC 6 498 Species: Skates and rays Rajiformes Zone: Union waters of 2a and 4 (SRX/2AC4-C) Belgium 292 (91) (92) (93) (94) Precautionary TAC Denmark 11 (91) (92) (93) Germany 14 (91) (92) (93) France 46 (91) (92) (93) (94) The Netherlands 249 (91) (92) (93) (94) United Kingdom 1 125 (91) (92) (93) (94) Union 1 737 (91) (93) TAC 1 737 (93) Species: Skates and rays Rajiformes Zone: Union waters of 3a (SRX/03A-C.) Denmark 37 (95) Precautionary TAC Sweden 10 (95) Union 47 (95) TAC 47 Species: Skates and rays Rajiformes Zone: Union waters of 6a, 6b, 7a-c and 7e-k (SRX/67AKXD) Belgium 920 (96) (97) (98) (99) Precautionary TAC Estonia 5 (96) (97) (98) (99) France 4 127 (96) (97) (98) (99) Germany 12 (96) (97) (98) (99) Ireland 1 329 (96) (97) (98) (99) Lithuania 21 (96) (97) (98) (99) The Netherlands 4 (96) (97) (98) (99) Portugal 23 (96) (97) (98) (99) Spain 1 111 (96) (97) (98) (99) United Kingdom 2 632 (96) (97) (98) (99) Union 10 184 (96) (97) (98) (99) TAC 10 184 (98) (99) Species: Skates and rays Rajiformes Zone: Union waters of 7d (SRX/07D.) Belgium 133 (100) (101) (102) (103) Precautionary TAC France 1 112 (100) (101) (102) (103) The Netherlands 7 (100) (101) (102) (103) United Kingdom 222 (100) (101) (102) (103) Union 1 474 (100) (101) (102) (103) TAC 1 474 (103) Species: Undulate ray Raja undulata Zone: Union waters of 7d and 7e (RJU/7DE.) Belgium 21 (104) Precautionary TAC Estonia 0 (104) France 105 (104) Germany 0 (104) Ireland 27 (104) Lithuania 0 (104) The Netherlands 0 (104) Portugal 0 (104) Spain 23 (104) United Kingdom 58 (104) Union 234 (104) TAC 234 (104) Species: Skates and rays Rajiformes Zone: Union waters of 8 and 9 (SRX/89-C.) Belgium 10 (105) (106) Precautionary TAC France 1 805 (105) (106) Portugal 1 463 (105) (106) Spain 1 471 (105) (106) United Kingdom 10 (105) (106) Union 4 759 (105) (106) TAC 4 759 (106) Species: Greenland halibut Reinhardtius hippoglossoides Zone: Union waters of 2a and 4; Union and international waters of 5b and 6 (GHL/2A-C46) Denmark 14 Analytical TAC Germany 25 Estonia 14 Spain 14 France 231 Ireland 14 Lithuania 14 Poland 14 United Kingdom 910 Union 1 250 Norway 1 250 (107) TAC 2 500 Species: Mackerel Scomber scombrus Zone: 3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32 (MAC/2A34.) Belgium 581 (108) (109) Analytical TAC Denmark 19 998 (108) (109) Article 7(2) of this Regulation applies Germany 606 (108) (109) France 1 830 (108) (109) The Netherlands 1 842 (108) (109) Sweden 5 459 (108) (109) (110) United Kingdom 1 706 (108) (109) Union 32 022 (108) (109) Norway 191 059 (111) TAC 922 064 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zones: 3a 3a and 4bc 4b 4c 6, international waters of 2a, from 1 January to 15 February and from 1 September to 31 December (MAC/*03A.) (MAC/*3A4BC) (MAC/*04B.) (MAC/*04C.) (MAC/*2A6.) Denmark 0 4 130 0 0 11 999 France 0 490 0 0 0 The Netherlands 0 490 0 0 0 Sweden 0 0 390 10 3 113 United Kingdom 0 490 0 0 0 Norway 3 000 0 0 0 0 Species: Mackerel Scomber scombrus Zone: 6, 7, 8a, 8b, 8d and 8e; Union and international waters of 5b; international waters of 2a, 12 and 14 (MAC/2CX14-) Germany 23 416 (112) Analytical TAC Spain 25 (112) Article 7(2) of this Regulation applies Estonia 195 (112) France 15 612 (112) Ireland 78 052 (112) Latvia 144 (112) Lithuania 144 (112) The Netherlands 34 147 (112) Poland 1 649 (112) United Kingdom 214 647 (112) Union 368 031 (112) Norway 16 492 (113) (114) Faroe Islands 34 856 (115) TAC 922 064 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zones and periods: Union waters of 2a; Union and Norwegian waters of 4a. During the periods from 1 January to 15 February and from 1 September to 31 December Norwegian waters of 2a Faroese waters (MAC/*4A-EN) (MAC/*2AN-) (MAC/*FRO2) Germany 14 132 1 904 1 948 France 9 422 1 268 1 299 Ireland 47 107 6 349 6 494 The Netherlands 20 609 2 776 2 841 United Kingdom 129 549 17 463 17 860 Union 220 819 29 760 30 442 Species: Mackerel Scomber scombrus Zone: 8c, 9 and 10; Union waters of CECAF 34.1.1 (MAC/8C3411) Spain 34 708 (116) Analytical TAC France 230 (116) Article 7(2) of this Regulation applies Portugal 7 174 (116) Union 42 112 TAC 922 064 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zone: 8b (MAC/*08B.) Spain 2 915 France 19 Portugal 602 Species: Mackerel Scomber scombrus Zone: Norwegian waters of 2a and 4a (MAC/2A4A-N) Denmark 14 453 Analytical TAC Union 14 453 TAC Not relevant Species: Common sole Solea solea Zone: 3a; Union waters of Subdivisions 22-24 (SOL/3ABC24) Denmark 447 Analytical TAC Germany 26 (117) Article 7(2) of this Regulation applies The Netherlands 43 (117) Sweden 17 Union 533 TAC 533 Species: Common sole Solea solea Zone: Union waters of 2a and 4 (SOL/24-C.) Belgium 1 461 Analytical TAC Denmark 668 Article 7(2) of this Regulation applies Germany 1 169 France 292 The Netherlands 13 194 United Kingdom 751 Union 17 535 Norway 10 (118) TAC 17 545 Species: Common sole Solea solea Zone: 6; Union and international waters of 5b; international waters of 12 and 14 (SOL/56-14) Ireland 46 Precautionary TAC United Kingdom 11 Union 57 TAC 57 Species: Common sole Solea solea Zone: 7a (SOL/07A.) Belgium 213 Analytical TAC France 3 Article 3 of Regulation (EC) No 847/96 shall not apply Ireland 77 Article 4 of Regulation (EC) No 847/96 shall not apply The Netherlands 68 United Kingdom 96 Union 457 TAC 457 Species: Common sole Solea solea Zone: 7b and 7c (SOL/7BC.) France 6 Precautionary TAC Ireland 36 Union 42 TAC 42 Species: Common sole Solea solea Zone: 7d (SOL/07D.) Belgium 753 Precautionary TAC France 1 506 Article 7(2) of this Regulation applies United Kingdom 538 Union 2 797 TAC 2 797 Species: Common sole Solea solea Zone: 7e (SOL/07E.) Belgium 52 Analytical TAC France 556 Article 7(2) of this Regulation applies United Kingdom 870 Union 1 478 TAC 1 478 Species: Common sole Solea solea Zone: 7f and 7g (SOL/7FG.) Belgium 1 032 Analytical TAC France 103 Article 7(2) of this Regulation applies Ireland 52 United Kingdom 465 Union 1 652 TAC 1 652 Species: Common sole Solea solea Zone: 7h, 7j and 7k (SOL/7HJK.) Belgium 27 Precautionary TAC France 55 Article 7(2) of this Regulation applies Ireland 148 The Netherlands 44 United Kingdom 55 Union 329 TAC 329 Species: Common sole Solea solea Zone: 8a and 8b (SOL/8AB.) Belgium 45 Analytical TAC Spain 8 Article 7(2) of this Regulation applies France 3 361 The Netherlands 252 Union 3 666 TAC 3 666 Species: Sole Solea spp. Zone: 8c, 8d, 8e, 9 and 10; Union waters of CECAF 34.1.1 (SOO/8CDE34) Spain 323 Precautionary TAC Portugal 535 Union 858 TAC 858 Species: Sprat and associated by-catches Sprattus sprattus Zone: 3a (SPR/03A.) Denmark 8 920 (119) (120) Analytical TAC Germany 19 (119) (120) Sweden 3 375 (119) (120) Union 12 314 (119) (120) TAC 13 312 (120) Species: Sprat and associated by-catches Sprattus sprattus Zone: Union waters of 2a and 4 (SPR/2AC4-C) Belgium 0 (121) (122) Analytical TAC Denmark 0 (121) (122) Germany 0 (121) (122) France 0 (121) (122) The Netherlands 0 (121) (122) Sweden 0 (121) (122) (123) United Kingdom 0 (121) (122) Union 0 (121) (122) Norway 0 (121) Faroe Islands 0 (121) (124) TAC 0 (121) Species: Sprat Sprattus sprattus Zone: 7d and 7e (SPR/7DE.) Belgium 8 Precautionary TAC Denmark 489 Germany 8 France 105 The Netherlands 105 United Kingdom 791 Union 1 506 TAC 1 506 Species: Picked dogfish Squalus acanthias Zone: Union and international waters of 1, 5, 6, 7, 8, 12 and 14 (DGS/15X14) Belgium 20 (125) Precautionary TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Germany 4 (125) Spain 10 (125) France 83 (125) Ireland 53 (125) The Netherlands 0 (125) Portugal 0 (125) United Kingdom 100 (125) Union 270 (125) TAC 270 (125) Species: Horse mackerel and associated by-catches Trachurus spp. Zone: Union waters of 4b, 4c and 7d (JAX/4BC7D) Belgium 12 (126) Precautionary TAC Denmark 5 311 (126) Germany 469 (126) (127) Spain 99 (126) France 441 (126) (127) Ireland 334 (126) The Netherlands 3 197 (126) (127) Portugal 11 (126) Sweden 75 (126) United Kingdom 1 264 (126) (127) Union 11 213 Norway 2 550 (128) TAC 13 763 Species: Horse mackerel and associated by-catches Trachurus spp. Zone: Union waters of 2a, 4a; 6, 7a-c,7e-k, 8a, 8b, 8d and 8e; Union and international waters of 5b; international waters of 12 and 14 (JAX/2A-14) Denmark 6 821 (129) (131) Analytical TAC Germany 5 322 (129) (130) (131) Spain 7 260 (131) (133) France 2 739 (129) (130) (131) (133) Ireland 17 726 (129) (131) The Netherlands 21 356 (129) (130) (131) Portugal 699 (131) (133) Sweden 675 (129) (131) United Kingdom 6 419 (129) (130) (131) Union 69 017 (131) Faroe Islands 1 600 (132) TAC 70 617 Species: Horse mackerel Trachurus spp. Zone: 8c (JAX/08C.) Spain 10 015 (134) Analytical TAC France 174 Portugal 990 (134) Union 11 179 TAC 11 179 Species: Horse mackerel Trachurus spp. Zone: 9 (JAX/09.) Spain 30 237 (135) Analytical TAC Portugal 86 634 (135) Article 7(2) of this Regulation applies Union 116 871 TAC 116 871 Species: Horse mackerel Trachurus spp. Zone: 10; Union waters of CECAF (136) (JAX/X34PRT) Portugal To be established Precautionary TAC Union To be established (137) Article 6 of this Regulation applies TAC To be established (137) Species: Horse mackerel Trachurus spp. Zone: Union waters of CECAF (138) (JAX/341PRT) Portugal To be established Precautionary TAC Union To be established (139) Article 6 of this Regulation applies TAC To be established (139) Species: Horse mackerel Trachurus spp. Zone: Union waters of CECAF (140) (JAX/341SPN) Spain To be established Precautionary TAC Union To be established (141) Article 6 of this Regulation applies TAC To be established (141) Species: Norway pout and associated by-catches Trisopterus esmarkii Zone: 3a; Union waters of 2a and 4 (NOP/2A3A4.) Year 2019 2020 Denmark 54 949 (142) (144) 64 940 (142) (147) Analytical TAC Germany 11 (142) (143) (144) 12 (142) (143) (147) Article 3 of Regulation (EC) No 847/96 shall not apply The Netherlands 40 (142) (143) (144) 48 (142) (143) (147) Article 4 of Regulation (EC) No 847/96 shall not apply Union 55 000 (142) (144) 65 000 (142) (147) Norway 14 500 (145) 14 500 (145) Faroe Islands 5 000 (146) 5 000 (146) TAC Not relevant Not relevant Species: Industrial fish Zone: Norwegian waters of 4 (I/F/04-N.) Sweden 800 (148) (149) Precautionary TAC Union 800 TAC Not relevant Species: Other species Zone: Union waters of 5b, 6 and 7 (OTH/5B67-C) Union Not relevant Precautionary TAC Norway 280 (150) TAC Not relevant Species: Other species Zone: Norwegian waters of 4 (OTH/04-N.) Belgium 60 Precautionary TAC Denmark 5 500 Germany 620 France 255 The Netherlands 440 Sweden Not relevant (151) United Kingdom 4 125 Union 11 000 (152) TAC Not relevant Species: Other species Zone: Union waters of 2a, 4 and 6a north of 56\u00b0 30' N (OTH/2A46AN) Union Not relevant Precautionary TAC Norway 6 750 (153) (154) Faroe Islands 150 (155) TAC Not relevant (1) Excluding waters within six nautical miles of the UK baselines at Shetland, Fair Isle and Foula. (2) Up to 2 % of the quota may consist of by-catches of whiting and mackerel (OT1/*2A3A4). By-catches of whiting and mackerel counted against the quota pursuant to this provision and by-catches of species counted against the quota pursuant to Article 15(8) of Regulation (EU) No 1380/2013 shall, together, not exceed 9 % of the quota. (3) In management areas 2r and 4 the TAC may only be fished as a monitoring TAC with an associated sampling protocol for the fishery. (4) Exclusively for by-catches. No directed fisheries are permitted under this quota. (5) Exclusively for by-catches. No directed fisheries are permitted under this quota. (6) Exclusively for by-catches. No directed fisheries are permitted under this quota. (7) To be fished in Union waters of 2a, 4, 5b, 6 and 7 (USK/*24X7C). (8) Special condition: of which an incidental catch of other species of 25 % per vessel, at any moment, is authorised in 5b, 6 and 7. However, this percentage may be exceeded in the first 24 hours following the beginning of the fishing on a specific ground. The total incidental catch of other species in 5b, 6 and 7 shall not exceed the amount below in tonnes (OTH/*5B67-). By-catch of cod under this provision in area 6a may not be more than 5 %. 3 000 (9) Including ling. The following quotas for Norway shall only be fished with long-lines in 5b, 6 and 7: Ling (LIN/*5B67-) 8 000 Tusk (USK/*5B67-) 2 923 (10) The tusk and ling quotas for Norway are interchangeable up to the following amount, in tonnes: 2 000 (11) Catches of herring taken in fisheries using nets with mesh sizes equal to or larger than 32 mm. (12) Special condition: up to 50 % of this amount may be fished in Union waters of 4 (HER/*04-C.). (13) Catches of herring taken in fisheries using nets with mesh sizes equal to or larger than 32 mm. (14) Catches taken within this quota are to be deducted from Norway's share of the TAC. Within the limit of this quota, no more than the quantity given below may be taken in Union waters of 4a and 4b (HER/*4AB-C). 50 000 (15) Catches of herring taken in fisheries using nets with mesh sizes equal to or larger than 32 mm. (16) By-catches of cod, haddock, pollack and whiting and saithe are to be counted against the quota for those species. (17) Exclusively for catches of herring taken as by-catch in fisheries using nets with mesh sizes smaller than 32 mm. (18) Exclusively for catches of herring taken as by-catch in fisheries using nets with mesh sizes smaller than 32 mm. (19) Exclusively for catches of herring taken in fisheries using nets with mesh sizes equal to or larger than 32 mm. (20) Except Blackwater stock: reference is to the herring stock in the maritime region of the Thames estuary within a zone delimited by a rhumb line running due south from Landguard Point (51\u00b0 56' N, 1\u00b0 19.1' E) to latitude 51\u00b0 33' N and hence due west to a point on the coast of the United Kingdom. (21) Special condition: up to 50 % of this quota may be taken in 4b (HER/*04B.). (22) Reference is to the herring stock in the part of ICES zone 6a which lies east of the meridian of longitude 7\u00b0 W and north of the parallel of latitude 55\u00b0 N, or west of the meridian of longitude 7\u00b0 W and north of the parallel of latitude 56\u00b0 N, excluding the Clyde. (23) It shall be prohibited to target any herring in the part of the ICES zones subject to this TAC that lies between 56\u00b0 N and 57\u00b0 30' N, with the exception of a six nautical mile belt measured from the baseline of the United Kingdom's territorial sea. (24) Reference is to the herring stock in 6a south of 56\u00b0 00' N and west of 07\u00b0 00' W. (25) Clyde stock: reference is to the herring stock in the maritime area situated to the north-east of a line drawn between: \u2014 the Mull of Kintyre (55\u00b0 17.9' N, 05\u00b0 47.8' W); \u2014 a point at position 55\u00b0 04' N, 05\u00b0 23' W, and; \u2014 Corsewall Point (55\u00b0 00.5' N, 05\u00b0 09.4' W). (26) Fixed at the same quantity as the quota of the United Kingdom. (27) This zone is reduced by the area bounded: \u2014 to the north by latitude 52\u00b0 30' N, \u2014 to the south by latitude 52\u00b0 00' N, \u2014 to the west by the coast of Ireland, \u2014 to the east by the coast of the United Kingdom. (28) This zone is increased by the area bounded: \u2014 to the north by latitude 52\u00b0 30' N, \u2014 to the south by latitude 52\u00b0 00' N, \u2014 to the west by the coast of Ireland, \u2014 to the east by the coast of the United Kingdom. (29) This quota may only be allocated to vessels participating in the sentinel fishery to allow fisheries-based data collection for this stock as assessed by ICES. The Member States concerned shall communicate the name(s) of the vessel(s) to the Commission before allowing any catches. (30) The quota may only be fished from 1 July 2020 to 30 June 2021. The TAC and the Member States quotas will be amended after the scientific advice is issued for this stock. The TAC and the quota for the period 1 July 2019 to 30 June 2020 has been established in the Council Regulation (EU) 2019/1601 of 26 September 2019 amending Regulations (EU) 2018/2025 and (EU) 2019/124 as regards certain fishing opportunities (OJ L 250, 30.9.2019, p. 1). (31) Exclusively for by-catches. No directed fisheries are permitted under this quota. (32) Special condition: of which up to 5 % may be fished in: 7d (COD/*07D.). (33) May be taken in Union waters. Catches taken within this quota are to be deducted from Norway's share of the TAC. (34) By-catches of haddock, pollack and whiting and saithe are to be counted against the quota for these species. (35) Exclusively for by-catches of cod in fisheries for other species. No directed fisheries for cod are permitted under this quota. (36) Exclusively for by-catches. No directed fisheries are permitted under this quota. (37) Exclusively for by-catches of cod in fisheries for other species. No directed fisheries for cod are permitted under this quota. (38) Special condition: of which up to 5 % may be fished in: 4; Union waters of 2a; that part of 3a not covered by the Skagerrak and Kattegat (COD/*2A3X4). (39) Special condition: of which up to 5 % may be fished in: Union waters of 2a and 4 (LEZ/*2AC4C). (40) 10 % of this quota may be used in 8a, 8b, 8d and 8e (LEZ/*8ABDE) for by-catches in directed fisheries for sole. (41) 35 % of this quota may be fished in 8a, 8b, 8d and 8e (LEZ/*8ABDE). (42) Special condition: of which up to 10 % may be fished in: 6; Union and international waters of 5b; international waters of 12 and 14 (ANF/*56-14). (43) Special condition: of which up to 5 % may be fished in: Union waters of 2a and 4 (ANF/*2AC4C). (44) Special condition: of which up to 10 % may be fished in 8a, 8b, 8d and 8e (ANF/*8ABDE). (45) By-catches of cod, pollack, whiting and saithe are to be counted against the quota for these species. (46) Not more than 10 % of this quota may be fished in 4; Union waters of 2a (HAD/*2AC4.). (47) May be taken in Union waters. Catches taken within this quota are to be deducted from Norway's share of the TAC. (48) Exclusively for by-catches of whiting in fisheries for other species. No directed fisheries for whiting are permitted under this quota. (49) Exclusively for by-catches of whiting in fisheries for other species. No directed fisheries for whiting are permitted under this quota. (50) By-catches of cod, haddock and saithe are to be counted against the quota for these species. (51) Transfers of this quota may be effected to Union waters of 2a and 4. However, such transfers shall be notified in advance to the Commission. (52) Not more than 10 % of this quota may be used for by-catch in 3a (HKE/*03A.). (53) Transfers of this quota may be effected to Union waters of 2a and 4. However, such transfers shall be notified in advance to the Commission. (54) Transfers of this quota may be effected to Union waters of 2a and 4. However, such transfers shall be notified in advance to the Commission. (55) Special condition: within a total access quantity of 37 500 tonnes for the Union, Member States may fish up to the following percentage of their quotas in Faroese waters (WHB/*05-F.): 7 %. (56) Transfers of this quota may be effected to 8c, 9 and 10; Union waters of CECAF 34.1.1. However, such transfers shall be notified in advance to the Commission. (57) Special condition: from the EU quotas in Union and international waters of 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 8d, 8e, 12 and 14 (WHB/*NZJM1) and in 8c, 9 and 10; Union waters of CECAF 34.1.1 (WHB/*NZJM2), the following quantity may be fished in the Norwegian Economic Zone or in the fishery zone around Jan Mayen: 190 809 (58) Special condition: from the EU quotas in Union and international waters of 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 8d, 8e, 12 and 14 (WHB/*NZJM1) and in 8c, 9 and 10; Union waters of CECAF 34.1.1 (WHB/*NZJM2), the following quantity may be fished in the Norwegian Economic Zone or in the fishery zone around Jan Mayen: 190 809 (59) To be counted against Norway's catch limits established under the Coastal States arrangement. (60) Special condition: the catch in 4a shall be no more than the following amount (WHB/*04A-C): 40 000 This catch limit in 4a amounts to the following percentage of Norway's access quota: 18 % (61) To be counted against the catch limits of the Faroe Islands. (62) Special conditions: may also be fished in 6b (WHB/*06B-C). The catch in 4a shall be no more than the following amount (WHB/*04A-C): 9 375 (63) Exclusively for by-catches. No directed fisheries are permitted under this quota. (64) To be fished in Union waters of 2a, 4, 5b, 6 and 7 (BLI/*24X7C). (65) By-catches of roundnose grenadier and black scabbardfish to be counted against this quota. To be fished in Union waters of 6a north of 56\u00b0 30\u2032N and 6b. This provision shall not apply for catches subject to the landing obligation. (66) Exclusively for by-catches. No directed fisheries are permitted under this quota. (67) Exclusively for by-catches. No directed fisheries are permitted under this quota. (68) Exclusively for by-catches. No directed fisheries are permitted under this quota. (69) Special condition: of which up to 25 % but no more than 75t may be fished in: Union waters of 3a (LIN/*03A-C). (70) Special condition: of which up to 35 % may be fished in: Union waters of 4 (LIN/*04-C.). (71) Special condition: of which an incidental catch of other species of 25 % per vessel, at any moment, is authorised in 5b, 6 and 7. However, this percentage may be exceeded in the first 24 hours following the beginning of the fishing on a specific ground. The total incidental catch of other species in 5b, 6 and 7 shall not exceed the amount below in tonnes (OTH/*6X14.). By-catch of cod under this provision in area 6a may not be more than 5 %. 3 000 (72) Including tusk. The quotas for Norway shall only be fished with long-lines in 5b, 6 and 7, and they amount to: Ling (LIN/*5B67-) 8 000 Tusk (USK/*5B67-) 2 923 (73) The ling and tusk quotas for Norway are interchangeable up to the following amount, in tonnes: 2 000 (74) Including tusk. To be fished in 6b and 6a north of 56\u00b030' N (LIN/*6BAN.). (75) Special condition: of which an incidental catch of other species of 20 % per vessel, at any moment, is authorised in 6a and 6b. However, this percentage may be exceeded in the first 24 hours following the beginning of the fishing on a specific ground. The total incidental catch of other species in 6a and 6b shall not exceed the following amount in tonnes (OTH/*6AB.): 75 (76) Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zone: Functional Unit 16 of ICES Subarea 7 (NEP/*07U16): Spain 795 France 498 Ireland 957 United Kingdom 387 Union 2 637 (77) Exclusively for catches taken as part of a sentinel fishery to collect catch per unit effort (CPUE) data with vessels carrying observers on board: \u2014 2 tonnes in functional unit 25 during five trips per month in August and September; \u2014 0,7 tonnes in functional unit 31 during 7 days in July. (78) Of which no more than 6 % may be taken in Functional Units 26 and 27 of ICES division 9a (NEP/*9U267). (79) Within the limits of the abovementioned TAC, no more than the following amount may be taken in Functional Unit 30 of ICES division 9a (NEP/*9U30): 77 (80) By-catches of cod, haddock, pollack, whiting and saithe are to be counted against the quotas for these species. (81) Fishing for shrimps Penaeus subtilis and Penaeus brasiliensis is prohibited in waters less than 30 metres deep. (82) Fixed at the same quantity as the quota of France. (83) Of which no more than 300 tonnes may be fished in the Skagerrak (PLE/*03AN.). (84) Exclusively for by-catches of plaice in fisheries for other species. No directed fisheries for plaice are permitted under this quota. (85) Special condition: of which up to 2 % may be fished in: 8a, 8b, 8d and 8e (POL/*8ABDE). (86) Special condition: of which up to 5 % may be fished in Union waters of 8c (POL/*08C.). (87) In addition to this TAC, Portugal may fish quantities of pollack not exceeding 98 tonnes (POL/93411P). (88) May only be taken in Union waters of 4 and in 3a (POK/*3A4-C). Catches taken within this quota are to be deducted from Norway's share of the TAC. (89) To be fished north of 56\u00b030' N (POK/*5614N). (90) By-catches of cod, haddock, pollack and whiting are to be counted against the quota for these species. (91) Catches of blonde ray (Raja brachyura) in Union waters of 4 (RJH/04-C.), cuckoo ray (Leucoraja naevus) (RJN/2AC4-C), thornback ray (Raja clavata) (RJC/2AC4-C) and spotted ray (Raja montagui) (RJM/2AC4-C) shall be reported separately. (92) By-catch quota. These species shall not comprise more than 25 % by live weight of the catch retained on board per fishing trip. This condition applies only to vessels over 15 metres' length overall. This provision shall not apply for catches subject to the landing obligation as set out in Article 15(1) of Regulation (EU) No 1380/2013. (93) Shall not apply to blonde ray (Raja brachyura) in Union waters of 2a and small-eyed ray (Raja microocellata) in Union waters of 2a and 4. When accidentally caught, these species shall not be harmed. Specimens shall be promptly released. Fishermen shall be encouraged to develop and use techniques and equipment to facilitate the rapid and safe release of the species. (94) Special condition: of which up to 10 % may be fished in Union waters of 7d (SRX/*07D2.), without prejudice to the prohibitions set out in Articles 16 and 52 for the areas specified therein. Catches of blonde ray (Raja brachyura) (RJH/*07D2.), cuckoo ray (Leucoraja naevus) (RJN/*07D2.), thornback ray (Raja clavata) (RJC/*07D2.) and spotted ray (Raja montagui) (RJM/*07D2.) shall be reported separately. This special condition shall not apply to small-eyed ray (Raja microocellata) and undulate ray (Raja undulata). (95) Catches of cuckoo ray (Leucoraja naevus) (RJN/03A-C.), blonde ray (Raja brachyura) (RJH/03A-C.) and spotted ray (Raja montagui) (RJM/03A-C.) shall be reported separately. (96) Catches of cuckoo ray (Leucoraja naevus) (RJN/67AKXD), thornback ray (Raja clavata) (RJC/67AKXD), blonde ray (Raja brachyura) (RJH/67AKXD), spotted ray (Raja montagui) (RJM/67AKXD), sandy ray (Raja circularis) (RJI/67AKXD) and shagreen ray (Raja fullonica) (RJF/67AKXD) shall be reported separately. (97) Special condition: of which up to 5 % may be fished in Union waters of 7d (SRX/*07D.), without prejudice to the prohibitions set out in Articles 16 and 52 for the areas specified therein. Catches of cuckoo ray (Leucoraja naevus) (RJN/*07D.), thornback ray (Raja clavata) (RJC/*07D.), blonde ray (Raja brachyura) (RJH/*07D.), spotted ray (Raja montagui) (RJM/*07D.), sandy ray (Raja circularis) (RJI/*07D.) and shagreen ray (Raja fullonica) (RJF/*07D.) shall be reported separately. This special condition shall not apply to small-eyed ray (Raja microocellata) and undulate ray (Raja undulata). (98) Shall not apply to small-eyed ray (Raja microocellata), except in Union waters of 7f and 7g. When accidentally caught, this species shall not be harmed. Specimens shall be promptly released. Fishermen shall be encouraged to develop and use techniques and equipment to facilitate the rapid and safe release of the species. Within the limits of the abovementioned quotas, no more than the quantities of small-eyed ray in Union waters of 7f and 7g (RJE/7FG.) provided below may be taken: Species: Small-eyed ray Raja microocellata Zone: Union waters of 7f and 7g (RJE/7FG.) Belgium 17 Precautionary TAC Estonia 0 France 79 Germany 0 Ireland 25 Lithuania 0 The Netherlands 0 Portugal 0 Spain 21 United Kingdom 50 Union 192 TAC 192 Special condition: of which up to 5 % may be fished in Union waters of 7d and reported under the following code: (RJE/*07D.). This special condition is without prejudice to the prohibitions set out in Articles 16 and 52 for the areas specified therein. (99) Shall not apply to undulate ray (Raja undulata). (100) Catches of cuckoo ray (Leucoraja naevus) (RJN/07D.), thornback ray (Raja clavata) (RJC/07D.), blonde ray (Raja brachyura) (RJH/07D.), spotted ray (Raja montagui) (RJM/07D.) and small-eyed ray (Raja microocellata) (RJE/07D.) shall be reported separately. (101) Special condition: of which up to 5 % may be fished in Union waters of 6a, 6b, 7a-c and 7e-k (SRX/*67AKD). Catches of cuckoo ray (Leucoraja naevus) (RJN/*67AKD), thornback ray (Raja clavata) (RJC/*67AKD), blonde ray (Raja brachyura) (RJH/*67AKD) and spotted ray (Raja montagui) (RJM/*67AKD) shall be reported separately. This special condition shall not apply to small-eyed ray (Raja microocellata) and to undulate ray (Raja undulata). (102) Special condition: of which up to 10 % may be fished in Union waters of 2a and 4 (SRX/*2AC4C). Catches of blonde ray (Raja brachyura) in Union waters of 4 (RJH/*04-C.), cuckoo ray (Leucoraja naevus) (RJN/*2AC4C), thornback ray (Raja clavata) (RJC/*2AC4C) and spotted ray (Raja montagui) (RJM/*2AC4C) shall be reported separately. This special condition shall not apply to small-eyed ray (Raja microocellata). (103) Shall not apply to undulate ray (Raja undulata). (104) This species shall not be targeted in the areas covered by this TAC. This species may only be landed whole or gutted. This provision is without prejudice to the prohibitions set out in Articles 16 and 52 for the areas specified therein. (105) Catches of cuckoo ray (Leucoraja naevus) (RJN/89-C.), blonde ray (Raja brachyura) (RJH/89-C.) and thornback ray (Raja clavata) (RJC/89-C.) shall be reported separately. (106) Shall not apply to undulate ray (Raja undulata). This species shall not be targeted in the areas covered by this TAC. In cases where it is not subject to the landing obligation, by-catch of undulate ray in subareas 8 and 9 may only be landed whole or gutted. The catches shall remain under the quotas shown in the table below. The above provisions are without prejudice to the prohibitions set out in Articles 16 and 52 for the areas specified therein. By-catches of undulate ray shall be reported separately under the codes indicated in the tables below. Within the limits of the abovementioned quotas, no more than the quantities of undulate ray given below may be taken: Species: Undulate ray Raja undulata Zone: Union waters of 8 (RJU/8-C.) Belgium 0 Precautionary TAC France 13 Portugal 10 Spain 10 United Kingdom 0 Union 33 TAC 33 Species: Undulate ray Raja undulata Zone: Union waters of 9 (RJU/9-C.) Belgium 0 Precautionary TAC France 20 Portugal 15 Spain 15 United Kingdom 0 Union 50 TAC 50 (107) To be taken in Union waters of 2a and 6. In 6 this quantity may only be fished with long-lines (GHL/*2A6-C). (108) Within the limits of the abovementioned quotas, no more than the quantities given below may also be taken in the two following zones: Norwegian waters of 2a (MAC/*02AN-) Faroese waters (MAC/*FRO1) Belgium 78 80 Denmark 2 695 2 756 Germany 82 84 France 247 252 The Netherlands 248 254 Sweden 736 753 United Kingdom 230 235 Union 4 316 4 414 (109) May also be taken in Norwegian waters of 4a (MAC/*4AN.). (110) Special condition: including the following tonnage to be taken in Norwegian waters of 2a and 4a (MAC/*2A4AN): 271 When fishing under this special condition, by-catches of cod, haddock, pollack and whiting and saithe are to be counted against the quotas for those species. (111) To be deducted from Norway's share of the TAC (access quota). This amount includes the following Norwegian share in the North Sea TAC: 55 397 This quota may be fished in 4a only (MAC/*04A.), except for the following amount, in tonnes, which may be fished in 3a (MAC/*03A.): 3 000 (112) Special condition: of which up to 25 % can be made available for exchanges to be fished by Spain, France and Portugal in 8c, 9 and 10 and Union waters of CECAF 34.1.1 (MAC/*8C910). (113) May be fished in 2a, 6a north of 56\u00b0 30' N, 4a, 7d, 7e, 7f and 7h (MAC/*AX7H). (114) The following additional amount of access quota, in tonnes, may be fished by Norway North of 56\u00b030' N and counted against its catch limit (MAC/*N5630): 38 212 (115) This amount shall be deducted from the Faroe Islands' catch limit (access quota). It may be fished only in 6a north of 56\u00b0 30' N (MAC/*6AN56). However, from 1 January to 15 February and from 1 October to 31 December this quota may also be fished in 2a, 4a north of 59\u00b0 (EU zone) (MAC/*24N59). (116) Special condition: quantities subject to exchanges with other Member States may be taken in 8a, 8b and 8d (MAC/*8ABD.). However, the quantities provided by Spain, Portugal or France for exchange purposes and to be taken in 8a, 8b and 8d shall not exceed 25 % of the quotas of the donor Member State. (117) Quota may be fished in Union waters of 3a, Subdivisions 22-24 only. (118) May be fished only in Union waters of 4 (SOL/*04-C.). (119) Up to 5 % of the quota may consist of by-catches of whiting and haddock (OTH/*03A.). By-catches of whiting and haddock counted against the quota pursuant to this provision and by-catches of species counted against the quota pursuant to Article 15(8) of Regulation (EU) No 1380/2013 shall, together, not exceed 9 % of the quota. (120) This quota may only be fished from 1 January 2020 to 30 June 2020. Transfers of this quota may be effected to Union waters of 2a and 4. However, such transfers shall be notified in advance to the Commission. (121) The quota may only be fished from 1 July 2020 to 30 June 2021. (122) Up to 2 % of the quota may consist of by-catches of whiting (OTH/*2AC4C). By-catches of whiting counted against the quota pursuant to this provision and by-catches of species counted against the quota pursuant to Article 15(8) of Regulation (EU) No 1380/2013 shall, together, not exceed 9 % of the quota. (123) Including sandeel. (124) May contain up to 4 % of by-catch of herring. (125) Picked dogfish shall not be targeted in the areas covered by this TAC. When accidentally caught in fisheries where picked dogfish is not subject to the landing obligation, specimens shall not be harmed and shall be released immediately, as required by Articles 16 and 52. By way of derogation from Article 16, a vessel engaged in the by-catch avoidance programme that has been positively assessed by the STECF may land not more than 2 tonnes per month of picked dogfish that is dead at the moment when the fishing gear is hauled on board. Member States participating in the by-catch avoidance programme shall ensure that the total annual landing of picked dogfish on the basis of this derogation does not exceed the above amounts. They shall communicate the list of participating vessels to the Commission before allowing any landings. Member States shall exchange information about avoidance areas. (126) Up to 5 % of the quota may consist of by-catches of boarfish, haddock, whiting and mackerel (OTH/*4BC7D). By-catches of boarfish, haddock, whiting and mackerel counted against the quota pursuant to this provision and by-catches of species counted against the quota pursuant to Article 15(8) of Regulation (EU) No 1380/2013 shall, together, not exceed 9 % of the quota. (127) Special condition: up to 5 % of this quota fished in division 7d may be accounted for as fished under the quota concerning the following zone: Union waters of 2a, 4a, 6, 7a-c,7e-k, 8a, 8b, 8d and 8e; Union and international waters of 5b; international waters of 12 and 14 (JAX/*2A-14). (128) May be fished in Union waters of 4a but may not be fished in Union waters of 7d (JAX/*04-C.). (129) Special condition: up to 5 % of this quota fished in Union waters of 2a or 4a before 30 June may be accounted for as fished under the quota concerning the zone of Union waters of 4b, 4c and 7d (JAX/*4BC7D). (130) Special condition: up to 5 % of this quota may be fished in 7d (JAX/*07D.). Under this special condition, and in accordance with footnote (3), by-catches of boarfish and whiting shall be reported separately under the following code: (OTH/*07D.). (131) Up to 5 % of the quota may consist of by-catches of boarfish, haddock, whiting and mackerel (OTH/*2A-14). By-catches of boarfish, haddock, whiting and mackerel counted against the quota pursuant to this provision and by-catches of species counted against the quota pursuant to Article 15(8) of Regulation (EU) No 1380/2013 shall, together, not exceed 9 % of the quota. (132) Limited to 4a, 6a (north of 56\u00b0 30' N only), 7e, 7f, 7h. (133) Special condition: up to 80 % of this quota may be fished in 8c (JAX/*08C2). Under this special condition, and in accordance with footnote (3), by-catches of boarfish and whiting shall be reported separately under the following code: (OTH/*08C2). (134) Special condition: up to 10 % of this quota may be fished in 9 (JAX/*09.). (135) Special condition: up to 10 % of this quota may be fished in 8c (JAX/*08C.). (136) Waters adjacent to the Azores. (137) Fixed at the same quantity as the quota of Portugal. (138) Waters adjacent to Madeira. (139) Fixed at the same quantity as the quota of Portugal. (140) Waters adjacent to the Canary Islands. (141) Fixed at the same quantity as the quota of Spain. (142) Up to 5 % of the quota may consist of by-catches of haddock and whiting (OT2/*2A3A4). By-catches of haddock and whiting counted against the quota pursuant to this provision and by-catches of species counted against the quota pursuant to Article 15(8) of Regulation (EU) No 1380/2013 shall, together, not exceed 9 % of the quota. (143) Quota may be fished in Union waters of ICES zones 2a, 3a and 4 only. (144) Union quota may only be fished from 1 November 2018 to 31 October 2019. (145) A sorting grid shall be used. (146) A sorting grid shall be used. Includes a maximum of 15 % of unavoidable by-catches (NOP/*2A3A4), to be counted against this quota. (147) Union quota may only be fished from 1 November 2019 to 31 October 2020. (148) By-catches of cod, haddock, pollack, whiting and saithe to be counted against the quotas for these species. (149) Special condition: of which no more than the following amount of horse mackerel (JAX/*04-N.): 400 (150) Taken with long-lines only. (151) Quota allocated by Norway to Sweden of \u2018other species\u2019 at a traditional level. (152) Including fisheries not specifically mentioned. Exceptions may be introduced after consultations, as appropriate. (153) Limited to 2a and 4 (OTH/*2A4-C). (154) Including fisheries not specifically mentioned. Exceptions may be introduced after consultations, as appropriate. (155) To be fished in 4 and 6a north of 56\u00b030' N (OTH/*46AN). Appendix The TACs referred to in Article 8(4) are the following: For Belgium: common sole in 7a; common sole in 7f and 7g; common sole in 7e; common sole in 8a and 8b; megrims in 7, haddock in 7b-k, 8, 9 and 10; Union waters of CECAF 34.1.1; Norway lobster in 7; cod in 7a; plaice in 7f and 7g; plaice in 7h, 7j and 7k; Skates and Rays in 6a, 6b, 7a-c and 7e-k. For France: mackerel in 3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32; herring in 4, 7d and Union waters of 2a; horse mackerel in Union waters of 4b, 4c and 7d; whiting in 7b-k; haddock in 7b-k, 8, 9 and 10; Union waters of CECAF 34.1.1; common sole in 7f and 7g; whiting in 8; red seabream in Union and international waters of 6, 7 and 8; boarfish in Union and international waters of 6, 7 and 8; mackerel in 6, 7, 8a, 8b, 8d and 8e; Union and international waters of 5b; international waters of 2a, 12 and 14; skates and rays in Union waters of 6a, 6b, 7a-c and 7e-k, skates and rays in Union waters of 7d, skates and rays in Union waters of 8 and 9; undulate ray in Union waters of 7d and 7e. For Ireland: anglerfish in 6; Union and international waters of 5b; international waters of 12 and 14; anglerfish in 7; Norway lobster in Functional Unit 16 of ICES Subarea 7. For the United Kingdom: in exchange for the West of Scotland cod and whiting: cod in 6b; Union and international waters of 5b west of 12\u00b0 00\u2032 W and of 12 and 14; whiting in 6; Union and international waters of 5b; international waters of 12 and 14; and in exchange for the Celtic Sea cod, Irish Sea whiting and plaice in 7h, 7j and 7k: cod in 7b, 7c, 7e-k, 8, 9 and 10; Union waters; haddock in 7b-k, 8, 9 and 10; Union waters of CECAF 34.1.1; sole in 7h, 7j and 7k; sole in 7e; plaice in 7h, 7j and 7k. ANNEX IB NORTH EAST ATLANTIC AND GREENLAND, ICES SUBAREAS 1, 2, 5, 12 AND 14 AND GREENLAND WATERS OF NAFO 1 Species: Herring Clupea harengus Zone: Union, Faroese, Norwegian and international waters of 1 and 2 (HER/1/2-) Belgium 12 (1) Analytical TAC Denmark 11 724 (1) Germany 2 053 (1) Spain 39 (1) France 506 (1) Ireland 3 035 (1) The Netherlands 4 195 (1) Poland 593 (1) Portugal 39 (1) Finland 181 (1) Sweden 4 344 (1) United Kingdom 7 495 (1) Union 34 216 (1) Faroe Islands 7 000 (2) (3) Norway 30 794 (2) (4) TAC 525 594 Special condition: within the limits of the abovementioned quotas, no more than the quantities given below may be taken in the following zones: Norwegian waters north of 62\u00b0 N and the fishery zone around Jan Mayen (HER/*2AJMN) 30 794 2, 5b north of 62\u00b0 N (Faroese waters) (HER/*25B-F) Belgium 2 Denmark 2 400 Germany 420 Spain 8 France 103 Ireland 621 The Netherlands 858 Poland 121 Portugal 8 Finland 37 Sweden 889 United Kingdom 1 533 Species: Cod Gadus morhua Zone: Norwegian waters of 1 and 2 (COD/1N2AB.) Germany 2 600 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Greece 322 Spain 2 900 Ireland 322 France 2 387 Portugal 2 900 United Kingdom 10 087 Union 21 518 TAC Not relevant Species: Cod Gadus morhua Zone: Greenland waters of NAFO 1F and Greenland waters of 5, 12 and 14 (COD/N1GL14) Germany 1 595 (5) Analytical TAC United Kingdom 355 (5) Article 3 of Regulation (EC) No 847/96 shall not apply Union 1 950 (5) Article 4 of Regulation (EC) No 847/96 shall not apply TAC Not relevant Species: Cod Gadus morhua Zone: 1 and 2b (COD/1/2B.) Germany 5 038 (8) Analytical TAC Spain 11 688 (8) Article 3 of Regulation (EC) No 847/96 shall not apply France 2 255 (8) Article 4 of Regulation (EC) No 847/96 shall not apply Poland 2 244 (8) Portugal 2 418 (8) United Kingdom 3 286 (8) Other Member States 366 (6) (8) Union 27 295 (7) (8) TAC Not relevant Species: Cod and haddock Gadus morhua and Melanogrammus aeglefinus Zone: Faroese waters of 5b (C/H/05B-F.) Germany 18 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply France 106 United Kingdom 761 Union 885 TAC Not relevant Species: Grenadiers Macrourus spp. Zone: Greenland waters of 5 and 14 (GRV/514GRN) Union 75 (9) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply TAC Not relevant (10) Article 4 of Regulation (EC) No 847/96 shall not apply Species: Grenadiers Macrourus spp. Zone: Greenland waters of NAFO 1 (GRV/N1GRN.) Union 60 (11) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply TAC Not relevant (12) Article 4 of Regulation (EC) No 847/96 shall not apply Species: Capelin Mallotus villosus Zone: 2b (CAP/02B.) Union 0 Analytical TAC TAC 0 Species: Capelin Mallotus villosus Zone: Greenland waters of 5 and 14 (CAP/514GRN) Denmark 0 Analytical TAC Germany 0 Article 3 of Regulation (EC) No 847/96 shall not apply Sweden 0 Article 4 of Regulation (EC) No 847/96 shall not apply United Kingdom 0 All Member States 0 (13) Union 0 (14) Norway 0 (14) TAC Not relevant Species: Haddock Melanogrammus aeglefinus Zone: Norwegian waters of 1 and 2 (HAD/1N2AB.) Germany 236 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply France 142 United Kingdom 722 Union 1 100 TAC Not relevant Species: Blue whiting Micromesistius poutassou Zone: Faroese waters (WHB/2A4AXF) Denmark 1 100 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Germany 75 France 120 The Netherlands 105 United Kingdom 1 100 Union 2 500 (15) TAC Not relevant Species: Ling and blue ling Molva molva and molva dypterygia Zone: Faroese waters of 5b (B/L/05B-F.) Germany 552 Analytical TAC France 1 225 Article 3 of Regulation (EC) No 847/96 shall not apply United Kingdom 108 Article 4 of Regulation (EC) No 847/96 shall not apply Union 1 885 (16) TAC Not relevant Species: Northern prawn Pandalus borealis Zone: Greenland waters of 5 and 14 (PRA/514GRN) Denmark 1 000 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply France 1 000 Union 2 000 Norway 1 200 Faroe Islands 1 200 TAC Not relevant Species: Northern prawn Pandalus borealis Zone: Greenland waters of NAFO 1 (PRA/N1GRN.) Denmark 1 400 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply France 1 400 Union 2 800 TAC Not relevant Species: Saithe Pollachius virens Zone: Norwegian waters of 1 and 2 (POK/1N2AB.) Germany 2 040 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply France 328 United Kingdom 182 Union 2 550 TAC Not relevant Species: Saithe Pollachius virens Zone: International waters of 1 and 2 (POK/1/2INT) Union 0 Analytical TAC TAC Not relevant Species: Saithe Pollachius virens Zone: Faroese waters of 5b (POK/05B-F.) Belgium 52 Analytical TAC Germany 322 Article 3 of Regulation (EC) No 847/96 shall not apply France 1 571 Article 4 of Regulation (EC) No 847/96 shall not apply The Netherlands 52 United Kingdom 603 Union 2 600 TAC Not relevant Species: Greenland halibut Reinhardtius hippoglossoides Zone: Norwegian waters of 1 and 2 (GHL/1N2AB.) Germany 25 (17) Analytical TAC United Kingdom 25 (17) Article 3 of Regulation (EC) No 847/96 shall not apply Union 50 (17) Article 4 of Regulation (EC) No 847/96 shall not apply TAC Not relevant Species: Greenland halibut Reinhardtius hippoglossoides Zone: International waters of 1 and 2 (GHL/1/2INT) Union 1 800 (18) Precautionary TAC TAC Not relevant Species: Greenland halibut Reinhardtius hippoglossoides Zone: Greenland waters of NAFO 1 (GHL/N1GRN.) Germany 1 925 (19) Analytical TAC Union 1 925 (19) Article 3 of Regulation (EC) No 847/96 shall not apply Norway 575 (19) Article 4 of Regulation (EC) No 847/96 shall not apply TAC Not relevant Species: Greenland halibut Reinhardtius hippoglossoides Zone: Greenland waters of 5, 12 and 14 (GHL/5-14GL) Germany 4 289 Analytical TAC United Kingdom 226 Article 3 of Regulation (EC) No 847/96 shall not apply Union 4 515 (20) Article 4 of Regulation (EC) No 847/96 shall not apply Norway 575 Faroe Islands 110 TAC Not relevant Species: Redfish (shallow pelagic) Sebastes spp. Zone: Union and international waters of 5; international waters of 12 and 14 (RED/51214S) Estonia 0 Analytical TAC Germany 0 Article 3 of Regulation (EC) No 847/96 shall not apply Spain 0 Article 4 of Regulation (EC) No 847/96 shall not apply France 0 Ireland 0 Latvia 0 The Netherlands 0 Poland 0 Portugal 0 United Kingdom 0 Union 0 TAC 0 Species: Redfish (deep pelagic) Sebastes spp. Zone: Union and international waters of 5; international waters of 12 and 14 (RED/51214D) Estonia 26 (21) (22) Analytical TAC Germany 519 (21) (22) Article 3 of Regulation (EC) No 847/96 shall not apply Spain 91 (21) (22) Article 4 of Regulation (EC) No 847/96 shall not apply France 48 (21) (22) Ireland 0 (21) (22) Latvia 9 (21) (22) The Netherlands 0 (21) (22) Poland 47 (21) (22) Portugal 109 (21) (22) United Kingdom 1 (21) (22) Union 850 (21) (22) TAC 5 500 (21) (22) Species: Redfish Sebastes mentella Zone: Norwegian waters of 1 and 2 (REB/1N2AB.) Germany 766 Analytical TAC Spain 95 Article 3 of Regulation (EC) No 847/96 shall not apply France 84 Article 4 of Regulation (EC) No 847/96 shall not apply Portugal 405 United Kingdom 150 Union 1 500 TAC Not relevant Species: Redfish Sebastes spp. Zone: International waters of 1 and 2 (RED/1/2INT) Union to be established (23) (24) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply TAC 13 686 (25) Article 4 of Regulation (EC) No 847/96 shall not apply Species: Redfish (pelagic) Sebastes spp. Zone: Greenland waters of NAFO 1F and Greenland waters of 5, 12 and 14 (RED/N1G14P) Germany 655 (26) (27) (28) Analytical TAC France 3 (26) (27) (28) Article 3 of Regulation (EC) No 847/96 shall not apply United Kingdom 5 (26) (27) (28) Article 4 of Regulation (EC) No 847/96 shall not apply Union 663 (26) (27) (28) Norway 561 (26) (27) Faroe Islands 0 (26) (27) (29) TAC Not relevant Species: Redfish (demersal) Sebastes spp. Zone: Greenland waters of NAFO 1F and Greenland waters of 5 and 14 (RED/N1G14D) Germany 1 976 (30) Analytical TAC France 10 (30) Article 3 of Regulation (EC) No 847/96 shall not apply United Kingdom 14 (30) Article 4 of Regulation (EC) No 847/96 shall not apply Union 2 000 (30) TAC Not relevant Species: Redfish Sebastes spp. Zone: Faroese waters of 5b (RED/05B-F.) Belgium 1 Analytical TAC Germany 92 Article 3 of Regulation (EC) No 847/96 shall not apply France 6 Article 4 of Regulation (EC) No 847/96 shall not apply United Kingdom 1 Union 100 TAC Not relevant Species: Other species Zone: Norwegian waters of 1 and 2 (OTH/1N2AB.) Germany 117 (31) Analytical TAC France 47 (31) Article 3 of Regulation (EC) No 847/96 shall not apply United Kingdom 186 (31) Article 4 of Regulation (EC) No 847/96 shall not apply Union 350 (31) TAC Not relevant Species: Other species (32) Zone: Faroese waters of 5b (OTH/05B-F.) Germany 281 Analytical TAC France 253 Article 3 of Regulation (EC) No 847/96 shall not apply United Kingdom 166 Article 4 of Regulation (EC) No 847/96 shall not apply Union 700 TAC Not relevant Species: Flatfish Zone: Faroese waters of 5b (FLX/05B-F.) Germany 9 Analytical TAC France 7 Article 3 of Regulation (EC) No 847/96 shall not apply United Kingdom 34 Article 4 of Regulation (EC) No 847/96 shall not apply Union 50 TAC Not relevant Species: By-catches (33) Zone: Greenland waters (B-C/GRL) Union 800 Precautionary TAC Article 3 of Regulation (EC) No 847/96 shall not apply TAC Not relevant Article 4 of Regulation (EC) No 847/96 shall not apply (1) When reporting catches to the Commission, the quantities fished in each of the following areas shall also be reported: NEAFC Regulatory Area and Union waters. (2) May be fished in Union waters north of 62\u00b0 N. (3) To be counted against the catch limits of the Faroe Islands. (4) To be counted against the catch limits of Norway. (5) Except for by-catches, the following conditions shall apply to these quotas: 1. They may not be fished between 1 April and 31 May. 2. EU vessels may choose to fish in either or both of the following areas: Reporting code Geographical limits COD/GRL1 The part of the Greenlandic fishing zone that lies within NAFO subarea 1F West of 44\u00b0 00' W and South of 60\u00b0 45' N, the portion of NAFO subarea 1 that lies south of the parallel of 60\u00b0 45' north latitude (Cape Desolation) and the part of the Greenlandic fishing zone within ICES division 14b that lies East of 44\u00b0 00' W and South of 62\u00b0 30' N. COD/GRL2 The part of the Greenlandic fishing area that lies within ICES division 14b North of 62\u00b0 30' N. (6) Except Germany, Spain, France, Poland, Portugal and the United Kingdom. (7) The allocation of the share of the cod stock available to the Union in the zone Spitzbergen and Bear Island and the associated by-catches of haddock are without prejudice to the rights and obligations deriving from the Treaty of Paris of 1920. (8) By-catches of haddock may represent up to 14 % per haul. The by-catch quantities of haddock are in addition to the quota for cod. (9) Special condition: roundnose grenadier (Coryphaenoides rupestris) (RNG/514GRN) and roughhead grenadier (Macrourus berglax) (RHG/514GRN) shall not be targeted. They shall only be taken as by-catch and shall be reported separately. (10) The amount below, in tonnes, is allocated to Norway. Special condition for this amount: roundnose grenadier (Coryphaenoides rupestris) (RNG/514GRN) and roughhead grenadier (Macrourus berglax) (RHG/514GRN) shall not be targeted. They shall only be taken as by-catch and shall be reported separately. 25 (11) Special condition: roundnose grenadier (Coryphaenoides rupestris) (RNG/N1GRN.) and roughhead grenadier (Macrourus berglax) (RHG/N1GRN.) shall not be targeted. They shall only be taken as by-catch and shall be reported separately. (12) The amount below, in tonnes, is allocated to Norway. Special condition for this amount: roundnose grenadier (Coryphaenoides rupestris) (RNG/N1GRN.) and roughhead grenadier (Macrourus berglax) (RHG/N1GRN.) shall not be targeted. They shall only be taken as by-catch and shall be reported separately. 40 (13) Denmark, Germany, Sweden and the United Kingdom may access the \u2018All Member States\u2019 quota only once they have exhausted their own quota. However, Member States with more than 10 % of the Union quota shall not access the \u2018All Member States\u2019 quota at all. (14) For a fishing period from 20 June 2019 to 30 April 2020. (15) Catches of blue whiting may include unavoidable by-catches of greater silver smelt. (16) By-catches of roundnose grenadier and black scabbardfish may be counted against this quota, up to the following limit (OTH/*05B-F): 665 (17) Exclusively for by-catches. No directed fisheries are permitted under this quota. (18) Exclusively for by-catches. No directed fisheries are permitted under this quota. (19) To be fished south of 68\u00b0 N. (20) To be fished by no more than 6 vessels at the same time. (21) May only be taken within the area bounded by the lines joining the following coordinates: Point Latitude Longitude 1 64\u00b0 45' N 28\u00b0 30' W 2 62\u00b0 50' N 25\u00b0 45' W 3 61\u00b0 55' N 26\u00b0 45' W 4 61\u00b0 00' N 26\u00b0 30' W 5 59\u00b0 00' N 30\u00b0 00' W 6 59\u00b0 00' N 34\u00b0 00' W 7 61\u00b0 30' N 34\u00b0 00' W 8 62\u00b0 50' N 36\u00b0 00' W 9 64\u00b0 45' N 28\u00b0 30' W (22) May only be taken from 10 May to 31 December. (23) The fishery will be closed when the TAC is fully used by NEAFC Contracting Parties. From the closure date, Member States shall prohibit directed fishery for redfish by vessels flying their flag. (24) Vessels shall limit their by-catches of redfish in other fisheries to a maximum of 1 % of the total catch retained on board. (25) Provisional catch limit to cover catches of all NEAFC contracting parties. (26) May only be fished from 10 May to 31 December. (27) May only be fished in Greenland waters within the Redfish Conservation Area bounded by the lines joining the following coordinates: Point Latitude Longitude 1 64\u00b0 45' N 28\u00b0 30' W 2 62\u00b0 50' N 25\u00b0 45' W 3 61\u00b0 55' N 26\u00b0 45' W 4 61\u00b0 00' N 26\u00b0 30' W 5 59\u00b0 00' N 30\u00b0 00' W 6 59\u00b0 00' N 34\u00b0 00' W 7 61\u00b0 30' N 34\u00b0 00' W 8 62\u00b0 50' N 36\u00b0 00' W 9 64\u00b0 45' N 28\u00b0 30' W (28) Special condition: this quota may also be fished in international waters of the Redfish Conservation Area mentioned above (RED/*5-14P). (29) May only be fished in Greenland Waters of 5 and 14 (RED/*514GN). (30) May only be fished by trawl, and only North and West of the line defined by the following coordinates: Point Latitude Longitude 1 59\u00b0 15' N 54\u00b0 26' W 2 59\u00b0 15' N 44\u00b0 00' W 3 59\u00b0 30' N 42\u00b0 45' W 4 60\u00b0 00' N 42\u00b0 00' W 5 62\u00b0 00' N 40\u00b0 30' W 6 62\u00b0 00' N 40\u00b0 00' W 7 62\u00b0 40' N 40\u00b0 15' W 8 63\u00b0 09' N 39\u00b0 40' W 9 63\u00b0 30' N 37\u00b0 15' W 10 64\u00b0 20' N 35\u00b0 00' W 11 65\u00b0 15' N 32\u00b0 30' W 12 65\u00b0 15' N 29\u00b0 50' W (31) Exclusively for by-catches. No directed fisheries are permitted under this quota. (32) Excluding fish species of no commercial value. (33) By-catches of grenadiers (Macrourus spp.) shall be reported in line with the following fishing opportunities tables: grenadiers in Greenland waters of 5 and 14 (GRV/514GRN) and grenadiers in Greenland waters of NAFO 1 (GRV/N1GRN.) ANNEX IC NORTH WEST ATLANTIC \u2013 NAFO CONVENTION AREA Species: Cod Gadus morhua Zone: NAFO 2J3KL (COD/N2J3KL) Union 0 (1) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply TAC 0 (1) Species: Cod Gadus morhua Zone: NAFO 3NO (COD/N3NO.) Union 0 (2) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply TAC 0 (2) Species: Cod Gadus morhua Zone: NAFO 3M (COD/N3M.) Estonia 95 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Germany 397 Latvia 95 Lithuania 95 Poland 324 Spain 1 221 France 170 Portugal 1 673 United Kingdom 795 Union 4 865 TAC 8 531 Species: Witch flounder Glyptocephalus cynoglossus Zone: NAFO 3L (WIT/N3L.) Union 0 (3) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply TAC 0 (3) Species: Witch flounder Glyptocephalus cynoglossus Zone: NAFO 3NO (WIT/N3NO.) Estonia 52 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Latvia 52 Lithuania 52 Union 156 TAC 1 175 Species: American plaice Hippoglossoides platessoides Zone: NAFO 3M (PLA/N3M.) Union 0 (4) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply TAC 0 (4) Species: American plaice Hippoglossoides platessoides Zone: NAFO 3LNO (PLA/N3LNO.) Union 0 (5) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply TAC 0 (5) Species: Shortfin squid Illex illecebrosus Zone: NAFO Subareas 3 and 4 (SQI/N34.) Estonia 128 (6) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Latvia 128 (6) Lithuania 128 (6) Poland 227 (6) Union Not relevant (6) (7) TAC 34 000 Species: Yellowtail flounder Limanda ferruginea Zone: NAFO 3LNO (YEL/N3LNO.) Union 0 (8) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply TAC 17 000 Species: Capelin Mallotus villosus Zone: NAFO 3NO (CAP/N3NO.) Union 0 (9) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply TAC 0 (9) Species: Northern prawn Pandalus borealis Zone: NAFO 3LNO (10) (11) (PRA/N3LNO.) Estonia 0 (12) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Latvia 0 (12) Lithuania 0 (12) Poland 0 (12) Spain 0 (12) Portugal 0 (12) Union 0 (12) TAC 0 (12) Species: Northern prawn Pandalus borealis Zone: NAFO 3M (13) (PRA/*N3M.) TAC Not relevant (14) Analytical TAC Species: Greenland halibut Reinhardtius hippoglossoides Zone: NAFO 3LMNO (GHL/N3LMNO) Estonia 340 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Germany 347 Latvia 48 Lithuania 24 Spain 4 650 Portugal 1 944 Union 7 353 TAC 12 542 Species: Skate Rajidae Zone: NAFO 3LNO (SKA/N3LNO.) Estonia 283 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Lithuania 62 Spain 3 403 Portugal 660 Union 4 408 TAC 7 000 Species: Redfish Sebastes spp. Zone: NAFO 3LN (RED/N3LN.) Estonia 895 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Germany 615 Latvia 895 Lithuania 895 Union 3 300 TAC 18 100 Species: Redfish Sebastes spp. Zone: NAFO 3M (RED/N3M.) Estonia 1 571 (15) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Germany 513 (15) Latvia 1 571 (15) Lithuania 1 571 (15) Spain 233 (15) Portugal 2 354 (15) Union 7 813 (15) TAC 8 590 (15) Species: Redfish Sebastes spp. Zone: NAFO 3O (RED/N3O.) Spain 1 771 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Portugal 5 229 Union 7 000 TAC 20 000 Species: Redfish Sebastes spp. Zone: NAFO Subarea 2, Divisions 1F and 3K (RED/N1F3K.) Latvia 0 (16) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Lithuania 0 (16) Union 0 (16) TAC 0 (16) Species: White hake Urophycis tenuis Zone: NAFO 3NO (HKW/N3NO.) Spain 255 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Portugal 333 Union 588 (17) TAC 1 000 (1) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the following limits: a maximum of 1 250 kg or 5 %, whichever is greater. (2) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the limits of a maximum of 1 000 kg or 4 %, whichever is greater. (3) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the following limits: a maximum of 1 250 kg or 5 %, whichever is greater. (4) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the following limits: a maximum of 1 250 kg or 5 %, whichever is greater. (5) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the following limits: a maximum of 1 250 kg or 5 %, whichever is greater. (6) To be fished between 1 July and 31 December 2020. (7) No specified Union\u2019s share. The amount specified below, in tonnes, is available to Canada and the Member States of the Union except Estonia, Latvia, Lithuania and Poland: 29 467 (8) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the following limits: a maximum of 2 500 kg or 10 %, whichever is greater. However, when the yellowtail flounder quota assigned by NAFO to Contracting Parties without a specific share of the stock is exhausted, by-catch limits shall be: a maximum of 1 250 kg or 5 %, whichever is greater. (9) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the following limits: a maximum of 1 250 kg or 5 %, whichever is greater. (10) Not including the box bounded by the following coordinates: Point No Latitude N Longitude W 1 47\u00b0 20' 0 46\u00b0 40' 0 2 47\u00b0 20' 0 46\u00b0 30' 0 3 46\u00b0 00' 0 46\u00b0 30' 0 4 46\u00b0 00' 0 46\u00b0 40' 0 (11) Fishing is prohibited at a depth less than 200 metres in the area West of a line bound by the following coordinates: Point No Latitude N Longitude W 1 46\u00b0 00' 0 47\u00b0 49' 0 2 46\u00b0 25' 0 47\u00b0 27' 0 3 46 \u00b042' 0 47\u00b0 25' 0 4 46\u00b0 48' 0 47\u00b0 25' 50 5 47\u00b0 16' 50 47\u00b0 43' 50 (12) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the following limits: a maximum of 1 250 kg or 5 %, whichever is greater. (13) Vessels may also fish this stock in Division 3L in the box bounded by the following coordinates: Point No Latitude N Longitude W 1 47\u00b0 20' 0 46\u00b0 40' 0 2 47\u00b0 20' 0 46\u00b0 30' 0 3 46\u00b0 00' 0 46\u00b0 30' 0 4 46\u00b0 00' 0 46\u00b0 40' 0 Moreover, fishing for shrimp is prohibited from 1 June to 31 December in the area bounded by the following coordinates: Point No Latitude N Longitude W 1 47\u00b0 55' 0 45\u00b0 00' 0 2 47\u00b0 30' 0 44\u00b0 15' 0 3 46\u00b0 55' 0 44\u00b0 15' 0 4 46\u00b0 35' 0 44\u00b0 30' 0 5 46\u00b0 35' 0 45\u00b0 40' 0 6 47\u00b0 30' 0 45\u00b0 40' 0 7 47\u00b0 55' 0 45\u00b0 00' 0 (14) Not relevant. Fishery managed by limitations in fishing effort (EFF/*N3M.). The Member States concerned shall issue fishing authorisations for their fishing vessels engaging in this fishery and shall notify those authorisations to the Commission prior to the commencement of the vessel\u2019s activity, in accordance with Regulation (EC) No 1224/2009. Member State Maximum number of fishing days Denmark 33 Estonia 391 (*1) Spain 64 Latvia 123 Lithuania 145 Poland 25 Portugal 17 (*1) The NAFO Commission agreed at its 2019 Annual Meeting that the European Union (Estonia) will transfer 25 fishing days of its fishing days allocation for 2020 to France, in respect of St Pierre et Miquelon. Those 25 fishing days have been deducted from Estonia\u2019s number of fishing days, which would otherwise have been 416 days, under this interim regime for 2020 that will not create any catch history. (15) This quota is subject to compliance with the TAC as shown, which is established for this stock for all NAFO Contracting Parties. Within that TAC, no more than the following mid-term limit may be fished before 1 July 2020: 4 295 (16) No directed fisheries are permitted under this quota. This species shall only be taken as by-catch within the following limits: a maximum of 1 250 kg or 5 %, whichever is greater. (17) Where, in accordance with Annex IA of the NAFO Conservation and Enforcement Measures, a positive vote by the Contracting Parties confirms the TAC to be 2 000 tonnes, the corresponding Union and Member State quotas shall be deemed to be as below: Spain 509 Portugal 667 Union 1 176 ANNEX ID ICCAT CONVENTION AREA Species: Bluefin tuna Thunnus thynnus Zone: Atlantic Ocean, east of 45\u00b0 W, and Mediterranean (BFT/AE45WM) Cyprus 169,35 (4) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Greece 314,77 (7) Spain 6 107,60 (2) (4) (7) France 6 026,60 (2) (3) (4) Croatia 952,53 (6) Italy 4 756,49 (4) (5) Malta 390,24 (4) Portugal 574,31 (7) Other Member States 68,11 (1) Union 19 360 (2) (3) (4) (5) Special additional allocation 100 (7) TAC 36 000 Species: Swordfish Xiphias gladius Zone: Atlantic Ocean, North of 5\u00b0 N (SWO/AN05N) Spain 6 509,07 (9) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Portugal 1 047,82 (9) (10) Other Member States 128,81 (8) (9) Union 7 685,70 (11) TAC 13 200 Species: Swordfish Xiphias gladius Zone: Atlantic Ocean, South of 5\u00b0 N (SWO/AS05N) Spain 4 712,18 (12) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Portugal 299,03 (12) Union 5 011,21 TAC 14 000 Species: Swordfish Xiphias gladius Zone: Mediterranian Sea (SWO/MED) Croatia 14,64 (13) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply. Article 4 of Regulation (EC) No 847/96 shall not apply. Cyprus 53,99 (13) Spain 1 667,58 (13) France 123,77 (13) Greece 1 103,91 (13) Italy 3 418,68 (13) Malta 405,58 (13) Union 6 780,60 (13) TAC 9 583,07 Species: Northern albacore Thunnus alalunga Zone: Atlantic Ocean, north of 5\u00b0 N (ALB/AN05N) Ireland 2 891,01 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Spain 16 312,85 France 5 203,15 United Kingdom 188,45 Portugal 2 273,97 Union 26 869,43 (14) TAC 33 600 Species: Southern albacore Thunnus alalunga Zone: Atlantic Ocean, south of 5\u00b0 N (ALB/AS05N) Spain 905,86 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply France 297,70 Portugal 633,94 Union 1 837,50 TAC 24 000 Species: Bigeye tuna Thunnus obesus Zone: Atlantic Ocean (BET/ATLANT) Spain 8 055,73 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply France 4 428,60 Portugal 3 058,33 Union 15 542,66 TAC 62 500 Species: Blue marlin Makaira nigricans Zone: Atlantic Ocean (BUM/ATLANT) Spain 22,88 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply France 380,48 Portugal 46,44 Union 449,80 (15) TAC 1 670 Species: White marlin Tetrapturus albidus Zone: Atlantic Ocean (WHM/ATLANT) Spain 0 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Portugal 0 Union 0 TAC 355 Species: Yellowfin tuna Thunnus albacares Zone: Atlantic Ocean (YFT/ATLANT) TAC 110 000 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Species: Sailfish Istiophorus albicans Zone: Atlantic Ocean, east of 45\u00b0 W (SAI/AE45W) TAC 1 271 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Species: Sailfish Istiophorus albicans Zone: Atlantic Ocean, west of 45\u00b0 W (SAI/AW45W) TAC 1 030 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Species: Blue shark Prionace glauca Zone: Atlantic Ocean, north of 5\u00b0 N (BSH/AN05N) Ireland 1 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Spain 27 062 France 152 Portugal 5 363 (16) Union 32 578 TAC 39 102 Species: Blue shark Prionace glauca Zone: Atlantic Ocean, south of 5\u00b0 N (BSH/AS05N) TAC 28 923 (17) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply (1) Except Cyprus, Greece, Spain, France, Croatia, Italy, Malta and Portugal, and exclusively as by-catch. (2) Special condition: within this TAC, the following catch limits and allocation between Member States shall apply to catches of bluefin tuna between 8 kg/75 cm and 30 kg/115 cm by the vessels referred to in point 1 of Annex VI (BFT/*8301): Spain 925,33 France 429,87 Union 1 355,20 (3) Special condition: within this TAC, the following catch limits and allocation between Member States shall apply to catches of bluefin tuna weighing no less than 6,4 kg or measuring no less than 70 cm by the vessels referred to in point 1 of Annex VI (BFT/*641): France 100 Union 100 (4) Special condition: within this TAC, the following catch limits and allocations between Member States shall apply to catches of bluefin tuna between 8 kg/75 cm and 30 kg/115 cm by the vessels referred to in point 2 of Annex VI (BFT/*8302): Spain 122,15 France 120,53 Italy 95,13 Cyprus 3,39 Malta 7,80 Union 349,01 (5) Special condition: within this TAC, the following catch limits and allocations between Member States shall apply to catches of bluefin tuna between 8 kg/75 cm and 30 kg/115 cm by the vessels referred to in point 3 of Annex VI (BFT/*643): Italy 95,13 Union 95,13 (6) Special Condition: within this TAC, the following catch limits and allocations between Member States shall apply to catches of bluefin tuna between 8 kg/75 cm and 30 kg/115 cm by the vessels referred to in point 3 of Annex VI for farming purposes (BFT/*8303F): Croatia 857,28 Union 857,28 (7) As agreed during the 2018 ICCAT Annual Meeting, in 2020 the European Union will receive, in addition to the allocated quota of 19 360 tonnes, an extra allocation of 100 tonnes, exclusively for artisanal vessels from specific archipelagos in Greece (Ionian Islands), Spain (Canary Islands) and Portugal (Azores and Madeira). The specific allocation of this additional quantity to the Member States concerned shall be as follows (BFT/AVARCH): Greece 4,5 Spain 87,3 Portugal 8,2 Union 100 (8) Except Spain and Portugal, and exclusively as by-catch. (9) Special condition: up to 2,39 % of this amount may be fished in the Atlantic Ocean, South of 5\u00b0 N (SWO/*AS05N). (10) 36,34 tonnes have been allocated to Portugal to compensate a double deduction in 2018. (11) After transfer of 40 tonnes to Saint-Pierre et Miquelon (ICCAT Rec. 17-02). (12) Special condition: up to 3,51 % of this amount may be fished in the Atlantic Ocean, North of 5\u00b0 N (SWO/*AN05N). (13) This quota may only be fished from 1 April to 31 December. (14) The number of Union fishing vessels fishing for northern albacore as a target species, in accordance with Article 12 of Regulation (EC) No 520/2007, shall be as follows: 1 253. (15) After transfer of 2 tonnes to Trinidad & Tobago (ICCAT Rec. 19-05). (16) The time period and the calculation method used by ICCAT to set the catch limit for North Atlantic blue shark shall not prejudge the time period and the calculation method used to define any future allocation key at Union level. (17) The time period and the calculation method used by ICCAT to set the catch limit for North Atlantic blue shark shall not prejudge the time period and the calculation method used to define any future allocation key at Union level. ANNEX IE SOUTH-EAST ATLANTIC OCEAN \u2013 SEAFO CONVENTION AREA The TACs set out below are not allocated to the members of SEAFO and hence the Union\u2019s share is undetermined. Catches are monitored by the SEAFO Secretariat which will communicate to the Contracting Parties when fishing is to be ceased due to a TAC exhaustion Species: Alfonsinos Beryx spp. Zone: SEAFO (ALF/SEAFO) TAC pm (1) Precautionary TAC Species: Deep-sea red crab Chaceon spp. Zone: SEAFO Subdivision B1 (2) (GER/F47NAM) TAC pm (2) Precautionary TAC Species: Deep-sea red crab Chaceon spp. Zone: SEAFO, excluding Subdivision B1 (GER/F47X) TAC pm Precautionary TAC Species: Patagonian toothfish Dissostichus eleginoides Zone: SEAFO Subarea D (TOP/F47D) TAC pm Precautionary TAC Species: Patagonian toothfish Dissostichus eleginoides Zone: SEAFO, excluding Suarea D (TOP/F47-D) TAC pm Precautionary TAC Species: Orange roughy Hoplostethus atlanticus Zone: SEAFO Subdivision B1 (3) (ORY/F47NAM) TAC pm (3) Precautionary TAC Species: Orange roughy Hoplostethus atlanticus Zone: SEAFO, excluding Subdivision B1 (ORY/F47X) TAC pm Precautionary TAC Species: Pelagic armourhead Pseudopentaceros spp. Zone: SEAFO (EDW/SEAFO) TAC pm Precautionary TAC (1) No more than 132 tonnes may be taken in Division B1 (ALF/*F47NA). (2) For the purpose of this TAC, the area open to the fishery is defined as having: \u2014 its western boundary on the longitude 0\u00b0 E; \u2014 its northern boundary on the latitude 20\u00b0 S; \u2014 its southern boundary on the latitude 28\u00b0 S, and \u2014 the eastern boundary outer limits of the Namibian EEZ. (3) For the purpose of this Annex, the area open to the fishery is defined as having: \u2014 its western boundary on the longitude 0\u00b0 E; \u2014 its northern boundary on the latitude 20\u00b0 S; \u2014 its southern boundary on the latitude 28\u00b0 S, and \u2014 the eastern boundary outer limits of the Namibian EEZ. (4) Except for a by-catch allowance of 4 tonnes (ORY/*F47NA). ANNEX IF SOUTHERN BLUEFIN TUNA \u2013 AREAS OF DISTRIBUTION Species: Southern bluefin tuna Thunnus maccoyii Zone: All areas of distribution (SBF/F41-81) Union 11 (1) Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply TAC 17 647 (1) Exclusively for by-catches. No directed fisheries are permitted under this quota. ANNEX IG WCPFC CONVENTION AREA Species: Bigeye tuna Thunnus obesus Zone: WCPFC Convention Area south of 20\u00b0 S (BET/F7120S) Union 2 000 (1) Precautionary TAC TAC Not relevant (1) Species: Swordfish Xiphias gladius Zone: WCPFC Convention Area south of 20\u00b0 S (SWO/F7120S) Union 3 170,36 Precautionary TAC TAC Not relevant (1) This quota may only be fished by vessels using longlines ANNEX IH SPRFMO CONVENTION AREA Species: Jack mackerel Trachurus murphyi Zone: SPRFMO Convention Area (CJM/SPRFMO) Germany to be established Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply The Netherlands to be established Lithuania to be established Poland to be established Union to be established TAC Not relevant Species: Toothfish Dissostichus spp. Zone: SPRFMO Convention Area (TOT/SPR-AE) TAC to be established (1) Precautionary TAC (1) This TAC is for exploratory fisheries only. Fishing shall only take place within the following research blocks (A-E): \u2014 Research block A: area bounded by latitudes 47\u00b0 15' S and 48\u00b0 15' S and by longitudes 146\u00b0 30' E and 147\u00b0 30' E, \u2014 Research block B: area bounded by latitudes 47\u00b0 15' S and 48\u00b0 15' S and by longitudes 147\u00b0 30' E and 148\u00b0 30' E, \u2014 Research block C: area bounded by latitudes 47\u00b0 15' S and 48\u00b0 15' S and by longitudes 148\u00b0 30' E and 150\u00b0 00' E, \u2014 Research block D: area bounded by latitudes 48\u00b0 15' S and 49\u00b0 15' S and by longitudes 149\u00b0 00' E and 150\u00b0 00' E, \u2014 Research block E: area bounded by latitudes 48\u00b0 15' S and 49\u00b0 30' S and by longitudes 150\u00b0 00' E and 151\u00b0 00' E. ANNEX IJ IOTC AREA OF COMPETENCE Catches of yellowfin tuna by Union purse seiners shall not exceed the catch limits set out in this Annex. Species: Yellowfin tuna Thunnus albacares Zone: IOTC Area of Competence (YFT/IOTC) France 29 501 Analytical TAC Article 3 of Regulation (EC) No 847/96 shall not apply Article 4 of Regulation (EC) No 847/96 shall not apply Italy 2 515 Spain 45 682 Union 77 698 TAC Not relevant ANNEX IK SIOFA AGREEMENT AREA Species: Toothfish Dissostichus spp. Zone: Del Cano Area (1) (TOT/F517DC) Union 18,33 (2) Precautionary TAC TAC 55 (2) Species: Toothfish Dissostichus spp. Zone: Williams Ridge (3) (TOT/F574WR) Union to be established (4) Precautionary TAC TAC 140 (4) (1) International waters in FAO Subarea 51.7 bounded between -44\u00b0 S and -45\u00b0 S latitude, and the adjacent exclusive economic zones to the east and west. (2) May only be fished by vessels with observers on board and using longlines during the fishing season from 1 December 2019 to 30 November 2020. Longlines shall not exceed 3 000 hooks per line and shall be set at minimum 3 nautical miles from each other. Catches of vessels not targeting this species may not exceed 0,5 tonnes per fishing season. When a vessel reaches this limit, it may no longer fish in Del Cano Area. (3) Area of FAO Subarea 57.4 bounded by the following coordinates: Point Latitude Longitude 1 52\u00b0 30' 00\" S 80\u00b0 00' 00\" E 2 55\u00b0 00' 00\" S 80\u00b0 00' 00\" E 3 55\u00b0 00' 00\" S 85\u00b0 00' 00\" E 4 52\u00b0 30' 00\" S 85\u00b0 00' 00\" E (4) May only be fished by vessels with observers on board during the fishing season from 1 December 2019 to 30 November 2020. No more than two longlines not exceeding 6 250 hooks are set per grid cell established by SIOFA and an interval of at least 30 days is applied between fishing trips according to the access conditions established by SIOFA. Catches of vessels not targeting this species may not exceed 0,5 tonnes per fishing season. When a vessel reaches this limit, it may no longer fish in Williams Ridge. ANNEX IL IATTC CONVENTION AREA Species: Bigeye tuna Thunnus obesus Zone: IATTC Convention Area (BET/IATTC) Union 500 (1) Precautionary TAC TAC Not relevant (1) This quota may only be fished by vessels using longlines. ANNEX II FISHING EFFORT FOR VESSELS IN THE CONTEXT OF THE MANAGEMENT OF WESTERN CHANNEL SOLE STOCKS IN ICES DIVISION 7e CHAPTER I General provisions 1. SCOPE 1.1. This Annex shall apply to Union fishing vessels of 10 metres length overall or more carrying on board or deploying beam trawls of mesh size equal to or greater than 80 mm and static nets, including gillnets, trammel-nets and tangle-nets, with mesh size equal to or less than 220 mm in accordance with Regulation (EC) No 509/2007, and present in ICES division 7e. 1.2. Vessels fishing with static nets with mesh size equal to or larger than 120 mm and with track records of less than 300 kg live weight of sole per year during the three previous years, according to their fishing records, shall be exempt from the application of this Annex subject to the following conditions: (a) such vessels caught less than 300 kg live weight of sole during the 2018 management period; (b) such vessels do not tranship any fish at sea to another vessel; (c) by 31 July 2020 and 31 January 2021 each Member State concerned makes a report to the Commission on those vessels' catch records for sole in the three previous years as well as on catches of sole in 2020. Where any of those conditions is not met, the vessels concerned shall cease to be exempt from the application of this Annex, with immediate effect. 2. DEFINITIONS For the purposes of this Annex, the following definitions apply: (a) \u2018gear grouping\u2019 means the grouping consisting of the following two gear categories: (i) beam trawls of mesh size equal to or greater than 80 mm, and (ii) static nets, including gillnets, trammel nets and tangle-nets, with mesh size equal to or less than 220 mm; (b) \u2018regulated gear\u2019 means any of the two gear categories belonging to the gear grouping; (c) \u2018area\u2019 means ICES division 7e; (d) \u2018current management period\u2019 means the period from 1 February 2020 to 31 January 2021. 3. LIMITATION IN ACTIVITY Without prejudice to Article 29 of Regulation (EC) No 1224/2009, each Member State shall ensure that, when carrying on board any regulated gear, Union fishing vessels flying its flag and registered in the Union shall be present within the area for no more than the number of days set out in Chapter III of this Annex. CHAPTER II Authorisations 4. AUTHORISED VESSELS 4.1 A Member State shall not authorise fishing with regulated gear in the area by any vessel flying its flag which has no record of such fishing activity in the area in the period from 2002 to 2018, excluding the record of fishing activities as a result of transfer of days between fishing vessels, unless it ensures that equivalent capacity, measured in kilowatts, is prevented from fishing in the area. 4.2 However, a vessel with a track record of using a regulated gear may be authorised to use a different fishing gear, provided that the number of days allocated to this latter gear is greater than or equal to the number of days allocated to the regulated gear. 4.3 A vessel flying the flag of a Member State having no quotas in the area shall not be authorised to fish in the area with regulated gear, unless the vessel is allocated a quota after a transfer as permitted in accordance with Article 16(8) of Regulation (EU) No 1380/2013 and is allocated days at sea in accordance with point 10 or 11 of this Annex. CHAPTER III Number of days present within the area allocated to Union fishing vessels 5. MAXIMUM NUMBER OF DAYS During the current management period, the maximum number of days at sea for which a Member State may authorise a vessel flying its flag to be present within the area carrying on board any regulated gear is shown in Table I. Table I Maximum number of days a vessel may be present within the area by category of regulated gear per year Regulated gear Maximum number of days Beam trawls of mesh size \u2265 80 mm Belgium 176 France 188 United Kingdom 222 Static nets with mesh size \u2264 220 mm Belgium 176 France 191 United Kingdom 176 6. KILOWATT DAY SYSTEM 6.1. During the current management period, a Member State may manage its fishing effort allocations in accordance with a kilowatt days system. Through that system it may authorise any vessel concerned by any regulated gear as set out in Table I to be present within the area for a maximum number of days which is different from that set out in that Table, provided that the overall amount of kilowatt days corresponding to the regulated gear is respected. 6.2. This overall amount of kilowatt days shall be the sum of all individual fishing efforts allocated to the vessels flying the flag of that Member State and qualified for the regulated gear. Such individual fishing efforts shall be calculated in kilowatt days by multiplying the engine power of each vessel by the number of days at sea it would benefit from, according to Table I, if point 6.1 were not applied. 6.3. A Member State wishing to benefit from the system referred to in point 6.1 shall submit a request to the Commission, for the regulated gear as laid down in Table I, with reports in electronic format containing the details of the calculation based on: (a) the list of vessels authorised to fish by indicating their Union fishing fleet register number (CFR) and their engine power; (b) the number of days at sea for which each vessel would have initially been authorised to fish according to Table I and the number of days at sea which each vessel would benefit from in application of point 6.1. 6.4. On the basis of that request, the Commission shall assess whether the conditions referred to in point 6 are complied with and, where applicable, may authorise that Member State to benefit from the system referred to in point 6.1. 7. ALLOCATION OF ADDITIONAL DAYS FOR PERMANENT CESSATION OF FISHING ACTIVITIES 7.1. An additional number of days at sea on which a vessel may be authorised by its flag Member State to be present within the area when carrying on board any regulated gear may be allocated to a Member State by the Commission on the basis of permanent cessations of fishing activities that have taken place during the preceding management period either in accordance with Article 23 of Regulation (EC) No 1198/2006 or with Regulation (EC) No 744/2008. Permanent cessations resulting from any other circumstances may be considered by the Commission on a case-by-case basis, following a written and duly motivated request from the Member State concerned. Such written request shall identify the vessels concerned and confirm, for each of them, that they shall never return to fishing activities. 7.2. The effort expended in 2003 measured in kilowatt days of the withdrawn vessels using a given gear grouping shall be divided by the effort expended by all vessels using that gear grouping during 2003. The additional number of days at sea shall be then calculated by multiplying the ratio so obtained by the number of days that would have been allocated according to Table I. Any part of a day resulting from that calculation shall be rounded to the nearest whole day. 7.3. Points 7.1 and 7.2 shall not apply where a vessel has been replaced in accordance with point 4.2, or when the withdrawal has already been used in previous years to obtain additional days at sea. 7.4. A Member State wishing to benefit from the allocations referred to in point 7.1 shall submit a request to the Commission, by 15 June of the current management period, with reports in electronic format containing for the gear grouping as laid down in Table I, the details of the calculation based on: (a) lists of withdrawn vessels with their Union fishing fleet register number (CFR) and their engine power; (b) the fishing activity deployed by such vessels in 2003 calculated in days at sea according to the grouping of fishing gear. 7.5. During the current management period, a Member State may re-allocate any additionally granted days at sea to all or part of the vessels remaining in fleet and qualified for the regulated gear. 7.6. When the Commission allocates additional days at sea due to a permanent cessation of fishing activities during the preceding management period the maximum number of days per Member State and gear shown in Table I shall be adjusted accordingly for the current management period. 8. ALLOCATION OF ADDITIONAL DAYS FOR ENHANCED SCIENTIFIC OBSERVER COVERAGE 8.1. Three additional days on which a vessel may be present within the area when carrying on board any regulated gear may be allocated between 1 February 2020 and 31 January 2021 to a Member State by the Commission on the basis of an enhanced programme of scientific observer coverage in partnership between scientists and the fishing industry. Such a programme shall focus in particular on levels of discarding and on catch composition and go beyond the requirements on data collection, as laid down in Regulation (EC) No 199/2008 and its implementing rules for national programmes. 8.2. Scientific observers shall be independent from the owner, the master of the fishing vessel and any crew member. 8.3. A Member State wishing to benefit from the allocations referred to in point 8.1 shall submit a description of its enhanced scientific observer coverage programme to the Commission for approval. 8.4. If an enhanced scientific observer coverage programme submitted by a Member State has been approved by the Commission in the past and the Member State concerned wishes to continue its application without changes, it shall inform the Commission of the continuation of that programme four weeks before the beginning of the period for which the programme applies. CHAPTER IV Management 9. GENERAL OBLIGATION Member States shall manage the maximum allowable effort in accordance with Articles 26 to 35 of Regulation (EC) No 1224/2009. 10. MANAGEMENT PERIODS 10.1. A Member State may divide the days present within the area set out in Table I into management periods of durations of one or more calendar months. 10.2. The number of days or hours for which a vessel may be present within the area during a management period shall be fixed by the Member State concerned. 10.3. Where a Member State authorises vessels flying its flag to be present within the area by hours, the Member State shall continue measuring the consumption of days as specified in point 9. Upon request by the Commission, the Member State shall demonstrate its precautionary measures taken to avoid an excessive consumption of days within the area due to a vessel terminating presences in the area before the end of a 24-hour period. CHAPTER V Exchanges of fishing effort allocations 11. TRANSFER OF DAYS BETWEEN FISHING VESSELS FLYING THE FLAG OF A MEMBER STATE 11.1. A Member State may permit any fishing vessel flying its flag to transfer days present within the area for which it has been authorised to another vessel flying its flag within the area, provided that the product of the number of days received by a vessel and its engine power in kilowatts (kilowatt days) is equal to or less than the product of the number of days transferred by the donor vessel and its engine power in kilowatts. The engine power in kilowatts of the vessels shall be that recorded for each vessel in the Union fishing fleet register. 11.2. The total number of days present within the area transferred in accordance with point 11.1, multiplied by the engine power in kilowatts of the donor vessel, shall not be higher than the donor vessel's average annual days track record in the area as verified by the fishing logbook in the years 2001, 2002, 2003, 2004 and 2005 multiplied by the engine power in kilowatts of that vessel. 11.3. The transfer of days in accordance with point 11.1 shall be permitted between vessels operating with any regulated gear and during the same management period. 11.4. On request from the Commission, Member States shall provide information on the transfers that have taken place. Formats of spreadsheet for the collection and transmission of that information may be established by the Commission, by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 53(2). 12. TRANSFER OF DAYS BETWEEN FISHING VESSELS FLYING THE FLAG OF DIFFERENT MEMBER STATES Member States may permit transfer of days present within the area for the same management period and within the area between any fishing vessels flying their flags provided that points 4.2, 4.4, 5, 6 and 10 apply mutatis mutandis. Where Member States decide to authorise such a transfer, they shall notify, before the transfer takes place, the Commission of the details of the transfer, including the number of days to be transferred, the fishing effort and, where applicable, the fishing quotas relating thereto. CHAPTER VI Reporting obligations 13. FISHING EFFORT REPORT Article 28 of Regulation (EC) No 1224/2009 shall apply to vessels falling under the scope of this Annex. The geographical area referred to in that Article shall be understood as the area specified in point 2 of this Annex. 14. COLLECTION OF RELEVANT DATA Member States shall collect on a quarterly basis the information about total fishing effort deployed within the area for towed gear and static gear, effort deployed by vessels using different types of gear in the area, and the engine power of those vessels in kilowatt days, on the basis of information used for the management of fishing days present within the area as set out in this Annex. 15. COMMUNICATION OF RELEVANT DATA Upon request from the Commission, Member States shall make available to the Commission a spreadsheet with data specified in point 14 in the format specified in Tables II and III by sending it to the appropriate electronic mailbox address, which shall be communicated to the Member States by the Commission. Member States shall, upon the Commission's request, send detailed information to the Commission on effort allocated and consumed covering all or parts of the 2018 and 2019 management periods, using the data format specified in Tables IV and V. Table II Reporting format kW-day information by management period Member State Gear Management period Cumulative effort declaration (1) (2) (3) (4) Table III Data format kW-day information by management period Name of field Maximum number of characters/digits Alignment (1) L(eft)/R(ight) Definition and comments (1) Member State 3 Member State (Alpha-3 ISO code) in which the vessel is registered (2) Gear 2 One of the following gear types: BT = beam trawls \u2265 80 mm GN = gillnet < 220 mm TN = trammel net or entangling net < 220 mm (3) Management period 4 One year in the period from the 2006 management period to the current management period (4) Cumulative effort declaration 7 R Cumulative amount of fishing effort expressed in kilowatt days deployed from 1 February until 31 January of the relevant management period Table IV Reporting format for vessel-related information Member State CFR External marking Length of management period Gear notified Days eligible using notified gear(s) Days spent with notified gear(s) Transfer of days No 1 No 2 No 3 \u2026 No 1 No 2 No 3 \u2026 No 1 No 2 No 3 \u2026 (1) (2) (3) (4) (5) (5) (5) (5) (6) (6) (6) (6) (7) (7) (7) (7) (8) Table V Data format for vessel-related information Name of field Maximum number of characters/digits Alignment (2) L(eft)/R(ight) Definition and comments (1) Member State 3 Member State (Alpha-3 ISO code) in which vessel is registered (2) CFR 12 Union fishing fleet register number (CFR) Unique identification number of a fishing vessel Member State (Alpha-3 ISO code) followed by an identifying series (9 characters). Where a series has fewer than 9 characters, additional zeros shall be inserted on the left hand side (3) External marking 14 L Under Implementing Regulation (EU) No 404/2011 (4) Length of management period 2 L Length of the management period measured in months (5) Gear notified 2 L One of the following gear types: BT = beam trawls \u2265 80 mm GN = gillnet < 220 mm TN = trammel net or entangling net < 220 mm (6) Special condition applying to notified gear(s) 3 L Number of days for which the vessel is eligible under Annex II for the choice of gear and length of management period notified (7) Days spent with notified gear(s) 3 L Number of days the vessel actually spent present within the area and using a gear corresponding to gear notified during the notified management period (8) Transfers of days 4 L For days transferred indicate \u2018\u2013 number of days transferred\u2019 and for days received indicate \u2018+ number of days transferred\u2019 (1) Information relevant for transmission of data by fixed-length formatting. (2) Information relevant for transmission of data by fixed-length formatting. ANNEX III MANAGEMENT AREAS FOR SANDEEL IN ICES DIVISIONS 2a, 3a AND ICES SUBAREA 4 For the purposes of the management of the fishing opportunities of sandeel in ICES divisions 2a, 3a and ICES subarea 4 fixed in Annex IA, the management areas within which specific catch limits apply are defined as shown below and in the Appendix to this Annex: Sandeel management area ICES statistical rectangles 1r 31\u201333 E9\u2013F4; 33 F5; 34\u201337 E9\u2013F6; 38\u201340 F0\u2013F5; 41 F4\u2013F5 2r 35 F7\u2013F8; 36 F7\u2013F9; 37 F7\u2013F8; 38-41 F6\u2013F8; 42 F6\u2013F9; 43 F7\u2013F9; 44 F9\u2013G0; 45 G0\u2013G1; 46 G1 3r 41\u201346 F1\u2013F3; 42\u201346 F4\u2013F5; 43\u201346 F6; 44\u201346 F7\u2013F8; 45\u201346 F9; 46\u201347 G0; 47 G1 and 48 G0 4 38\u201340 E7\u2013E9 and 41\u201346 E6\u2013F0 5r 47\u201352 F1\u2013F5 6 41\u201343 G0\u2013G3; 44 G1 7r 47\u201352 E6\u2013F0 Appendix Sandeel management areas ANNEX IV SEASONAL CLOSURES TO PROTECT SPAWNING COD The areas set out in the table below shall be closed for all gear, except pelagic gear (purse seines and trawls), during the identified period: Time-limited closures No Area name Coordinates Period Additional comment 1 Stanhope ground 60\u00b0 10' N - 01\u00b0 45' E 60\u00b0 10' N - 02\u00b0 00' E 60\u00b0 25' N - 01\u00b0 45' E 60\u00b0 25' N - 02\u00b0 00' E 1 January to 30 April 2 Long Hole 59\u00b0 07,35' N - 0\u00b0 31,04' W 59\u00b0 03,60' N - 0\u00b0 22,25' W 58\u00b0 59,35' N - 0\u00b0 17,85' W 58\u00b0 56,00' N - 0\u00b0 11,01' W 58\u00b0 56,60' N - 0\u00b0 08,85' W 58\u00b0 59,86' N - 0\u00b0 15,65' W 59\u00b0 03,50' N - 0\u00b0 20,00' W 59\u00b0 08,15' N - 0\u00b0 29,07' W 1 January to 31 March 3 Coral edge 58\u00b0 51,70' N - 03\u00b0 26,70' E 58\u00b0 40,66' N - 03\u00b0 34,60' E 58\u00b0 24,00' N - 03\u00b0 12,40' E 58\u00b0 24,00' N - 02\u00b0 55,00' E 58\u00b0 35,65' N - 02\u00b0 56,30' E 1 January to 28 February 4 Papa Bank 59\u00b0 56' N - 03\u00b0 08' W 59\u00b0 56' N - 02\u00b0 45' W 59\u00b0 35' N - 03\u00b0 15' W 59\u00b0 35' N - 03\u00b0 35' W 1 January to 15 March 5 Foula Deeps 60\u00b0 17,50' N - 01\u00b0 45' W 60\u00b0 11,00' N - 01\u00b0 45' W 60\u00b0 11,00' N - 02\u00b0 10' W 60\u00b0 20,00' N - 02\u00b0 00' W 60\u00b0 20,00' N - 01\u00b0 50' W 1 November to 31 December 6 Egersund Bank 58\u00b0 07,40' N - 04\u00b0 33,00' E 57\u00b0 53,00' N - 05\u00b0 12,00' E 57\u00b0 40,00' N - 05\u00b0 10,90' E 57\u00b0 57,90' N - 04\u00b0 31,90' E 1 January to 31 March (10 \u00d7 25 nautical miles) 7 East of Fair Isle 59\u00b0 40' N - 01\u00b0 23' W 59\u00b0 40' N - 01\u00b0 13' W 59\u00b0 30' N - 01\u00b0 20' W 59\u00b0 10' N - 01\u00b0 20' W 59\u00b0 30' N - 01\u00b0 28' W 59\u00b0 10' N - 01\u00b0 28' W 1 January to 15 March 8 West Bank 57\u00b0 15' N - 05\u00b0 01' E 56\u00b0 56' N - 05\u00b0 00' E 56\u00b0 56' N - 06\u00b0 20' E 57\u00b0 15' N - 06\u00b0 20' E 1 February to 15 March (18 \u00d7 4 nautical miles) 9 Revet 57\u00b0 28,43' N - 08\u00b0 05,66' E 57\u00b0 27,44' N - 08\u00b0 07,20' E 57\u00b0 51,77' N - 09\u00b0 26,33' E 57\u00b0 52,88' N - 09\u00b0 25,00' E 1 February 15 March (1,5 \u00d7 49 nautical miles) 10 Rabarberen 57\u00b0 47,00' N - 11\u00b0 04,00' E 57\u00b0 43,00' N - 11\u00b0 04,00' E 57\u00b0 43,00' N - 11\u00b0 09,00' E 57\u00b0 47,00' N - 11\u00b0 09,00' E 1 February \u2013 15 March East of Skagen (2,7 \u00d7 4 nautical miles) ANNEX V FISHING AUTHORISATIONS PART A MAXIMUM NUMBER OF FISHING AUTHORISATIONS FOR UNION FISHING VESSELS FISHING IN THIRD-COUNTRY WATERS Area of fishing Fishery Number of fishing authorisations Allocation of fishing authorisations amongst Member States Maximum number of vessels present at any time Norwegian waters and fishery zone around Jan Mayen Herring, north of 62\u00b0 00' N 77 DK 25 57 DE 5 FR 1 IE 8 NL 9 PL 1 SV 10 UK 18 Demersal species, north of 62\u00b0 00' N 80 DE 16 50 IE 1 ES 20 FR 18 PT 9 UK 14 Unallocated 2 Mackerel (1) Not relevant Not relevant 70 Industrial species, south of 62\u00b0 00' N 480 DK 450 150 UK 30 Faroese waters All trawl fisheries with vessels of not more than 180 feet in the zone between 12 and 21 miles from the Faroese baselines 26 BE 0 13 DE 4 FR 4 UK 18 Directed fisheries for cod and haddock with a minimum mesh of 135 mm, restricted to the area south of 62\u00b0 28\u2032 N and east of 6\u00b0 30\u2032 W 8 (2) Not relevant 4 Trawl fisheries outside 21 miles from the Faroese baseline. In the periods from 1 March to 31 May and from 1 October to 31 December, those vessels may operate in the area between 61\u00b0 20\u2032 N and 62\u00b0 00\u2032 N and between 12 and 21 miles from the baselines 70 BE 0 26 DE 10 FR 40 UK 20 Trawl fisheries for blue ling with a minimum mesh of 100 mm in the area south of 61\u00b0 30\u2032 N and west of 9\u00b0 00\u2032 W and in the area between 7\u00b0 00\u2032 W and 9\u00b0 00\u2032 W south of 60\u00b0 30\u2032 N and in the area south-west of a line between 60\u00b0 30\u2032 N, 7\u00b0 00\u2032 W and 60\u00b000\u2032 N, 6\u00b000\u2032 W 70 DE (3) 8 20 (4) FR (3) 12 Directed trawl fisheries for saithe with a minimum mesh size of 120 mm and with the possibility to use round-straps around the cod-end 70 Not relevant 22 (4) Fisheries for blue whiting. The total number of fishing authorisations may be increased by four vessels to form pairs, should the Faroese authorities introduce special rules of access to an area called \u2018main fishing area of blue whiting\u2019 34 DE 2 20 DK 5 FR 4 NL 6 UK 7 SE 1 ES 4 IE 4 PT 1 Line fisheries 10 UK 10 6 Mackerel 20 DK 2 12 BE 1 DE 2 FR 2 IE 3 NL 2 SE 2 UK 6 Herring, north of 62\u00b0 00' N 20 DK 5 20 DE 2 IE 2 FR 1 NL 2 PL 1 SE 3 UK 4 1, 2b (5) Fishery for snow crab with pots 20 EE 1 Not applicable ES 1 LV 11 LT 4 PL 3 PART B MAXIMUM NUMBER OF FISHING AUTHORISATIONS FOR THIRD-COUNTRY VESSELS FISHING IN UNION WATERS Flag State Fishery Number of fishing authorisations Maximum number of vessels present at any time Norway Herring, north of 62\u00b0 00' N To be established To be established Faroe Islands Mackerel, 6a (north of 56\u00b0 30' N), 2a, 4a (north of 59\u00b0 N) Horse mackerel, 4, 6a (north of 56\u00b0 30' N), 7e, 7f, 7h 20 14 Herring, north of 62\u00b0 00' N 20 To be established Herring, 3a 4 4 Industrial fishing for Norway pout, 4, 6a (north of 56\u00b0 30' N) (including unavoidable by-catches of blue whiting) 14 14 Ling and tusk 20 10 Blue whiting, 2, 4a, 5, 6a (north of 56\u00b0 30' N), 6b, 7 (west of 12\u00b0 00' W) 20 20 Blue ling 16 16 Venezuela (6) Snappers (French Guiana waters) 45 45 (1) Without prejudice to additional licences granted to Sweden by Norway in accordance with established practice. (2) Those figures are included in the figures for all trawl fisheries with vessels of not more than 180 feet in the zone between 12 and 21 miles from the Faroese baselines. (3) Those figures refer to the maximum number of vessels present at any time. (4) Those figures are included in the figures for \u2018Trawl fisheries outside 21 miles from the Faroese baselines\u2019. (5) The allocation of fishing opportunities available to the Union in the zone of Svalbard is without prejudice to the rights and obligations deriving from the Treaty of Paris of 1920. (6) To issue those fishing authorisations, proof must be produced that a valid contract exists between the vessel owner applying for the fishing authorisation and a processing undertaking situated in the Department of French Guiana, and that it includes an obligation to land at least 75 % of all snapper catches from the vessel concerned in that department so that they may be processed in that undertaking\u2019s plant. Such a contract must be endorsed by the French authorities, which shall ensure that it is consistent both with the actual capacity of the contracting processing undertaking and with the objectives for the development of the Guianese economy. A copy of the duly endorsed contract shall be appended to the fishing authorisation application. Where such an endorsement is refused, the French authorities shall give notification of this refusal and state their reasons for it to the party concerned and to the Commission. ANNEX VI ICCAT CONVENTION AREA (1) 1. Maximum number of Union bait boats and trolling boats authorised to fish actively for bluefin tuna between 8 kg/75 cm and 30 kg/115 cm in the Eastern Atlantic Spain 60 France 37 Union 97 2. Maximum number of Union coastal artisanal fishing vessels authorised to fish actively for bluefin tuna between 8 kg/75 cm and 30 kg/115 cm in the Mediterranean Spain 364 France 130 Italy 30 Cyprus 20 (2) Malta 54 (2) Union 598 3. Maximum number of Union fishing vessels authorised to fish actively for bluefin tuna between 8 kg/75 cm and 30 kg/115 cm in the Adriatic Sea for farming purposes Croatia 16 Italy 12 Union 28 4. Maximum number of fishing vessels of each Member State that may be authorised to fish for, retain on board, tranship, transport, or land bluefin tuna in the eastern Atlantic and Mediterranean Table A (3) Number of fishing vessels (4) Cyprus (5) Greece (6) Croatia Italy France Spain Malta (7) Portugal Purse seiners 1 1 16 19 22 6 1 0 Longliners 23 (8) 0 0 35 8 49 61 0 Baitboat 0 0 0 0 37 69 0 76 (9) Handline 0 0 12 0 33 (10) 1 0 0 Trawler 0 0 0 0 57 0 0 0 Small-scale 0 13 0 0 130 599 52 0 Other artisanal (11) 0 42 0 0 0 0 0 0 5. Maximum number of traps engaged in the eastern Atlantic and Mediterranean bluefin tuna fishery authorised by each Member State (12) Member State Number of traps (13) Spain 5 Italy 6 Portugal 3 6. Maximum bluefin tuna farming capacity and fattening capacity for each Member State and maximum input of wild caught bluefin tuna that each Member State may allocate to its farms in the eastern Atlantic and Mediterranean Table A Maximum tuna farming capacity and fattening capacity Number of farms Capacity (in tonnes) Spain 10 11 852 Italy 13 12 600 Greece 2 2 100 Cyprus 3 3 000 Croatia 7 7 880 Malta 6 12 300 Table B (14) Maximum input of wild caught bluefin tuna (in tonnes) (15) Spain 6 300 Italy 3 764 Greece 785 Cyprus 2 195 Croatia 2 947 Malta 8 786 Portugal 350 7. The distribution between the Member States of the maximum number of fishing vessels flying the flag of a Member State authorised to fish for northern albacore as a target species in accordance with Article 12 of Regulation (EC) No 520/2007 shall be as follows: Member State Maximum number of vessels Ireland 50 Spain 730 France 151 United Kingdom 12 Portugal 310 8. Maximum number of Union fishing vessels of at least 20 meters length that fish for bigeye tuna in the ICCAT Convention Area shall be as follows: Member State Maximum number of vessels with purse seines Maximum number of vessels with longlines Spain 23 190 France 11 \u2014 Portugal \u2014 79 Union 34 269 (1) The numbers shown in sections 1, 2 and 3 may decrease in order to comply with international obligations of the Union. (2) This number may increase if a purse seiner is replaced by 10 longline vessels in accordance with footnote 4 or footnote 6 of table A in point 4 of this Annex. (3) The numbers in table A should be adapted in light of fishing plans submitted by Member states by 31 January 2020. (4) The numbers in this Table A of section 4 may be further increased, provided that the international obligations of the Union are complied with. (5) One medium-size purse seiner may be replaced by no more than 10 longline vessels or one small purse seiner and no more than three longline vessels. (6) One medium-size purse seiner may be replaced by no more than 10 longline vessels or one small-size purse seiner and three other artisanal vessels. (7) One medium-size purse seiner may be replaced by no more than 10 longline vessels. (8) Polyvalent vessels, using multi-gear equipment. (9) Baitboats of the outermost regions of Azores and Madeira. (10) Line vessels operating in the Atlantic. (11) Polyvalent vessels, using multi-gear equipment (longline, handline, trolling line). (12) The numbers in section 5 must be adapted in light of fishing plans submitted by Member states by 31 January 2020 for endorsement by Panel 2 of ICCAT on 6 March 2020. (13) This number may be further increased, provided that the international obligations of the Union are complied with. (14) The total farming capacity of Portugal of 500 tonnes (corresponding to 350 tonnes of input farming capacity) is covered by the unused capacity of the Union set out in table A. (15) The figures in table B in section 6 must be adapted in light of the farming plans submitted by Member states by 31 January 2020. ANNEX VII CCAMLR CONVENTION AREA Exploratory fishing for toothfish in the CCAMLR Convention Area in 2019/2020 shall be limited to the following: Table A Authorised Member States, subareas and maximum number of vessels Member State Area Maximum number of vessels Spain 48.6 1 Spain 88.1 1 Table B TACs and by-catch limits The TACs set out below, which are adopted by CCAMLR, are not allocated to CCAMLR members and hence the Union\u2019s share is undetermined. Catches are monitored by the CCAMLR Secretariat which will communicate to the Contracting Parties when fishing is to be ceased due to TAC exhaustion Subarea Region Season SSRUs (48.6) or research blocks (88.1) Dissostichus mawsoni catch limit (in tonnes)/SSRUs (48.6) or research blocks (88.1) Dissostichus mawsoni catch limit (in tonnes)/whole subarea By-catch limit (in tonnes)/SSRUs (48.6) or research blocks (88.1) Skates and rays Macrourus spp. (1) Other species 48.6 Whole subarea 1 December 2019 to 30 November 2020 48.6_2 140 670 7 22 22 48.6_3 38 2 6 6 48.6_4 163 8 26 26 48.6_5 329 16 53 23 88.1. Whole subarea 1 December 2019 to 31 August 2020 A, B, C, G (2) 597 3 140 (3) 30 96 30 G, H, I, J, K (4) 2 072 104 317 104 Special Research Zone of the Ross Sea Region marine protected area 426 23 72 23 (1) In area 88.1, where the catch of Macrourus spp. taken by a single vessel in any two 10-day periods (i.e. from day 1 to day 10, day 11 to day 20, or day 21 to the last day of the month) in any SSRU exceeds 1 500 kg in each 10-day period and exceeds 16 % of the catch of Dissostichus spp. by that vessel in that SSRU, the vessel shall cease fishing in that SSRU for the remainder of the season. (2) All areas outside the Ross Sea region marine protected area and north of 70\u00b0 S. (3) The target species is Dissostichus mawsoni. Any Dissostichus eleginoides caught shall be counted towards the overall catch limit for Dissostichus mawsoni. (4) All areas outside the Ross Sea region marine protected area and south of 70\u00b0 S. Appendix PART A Research blocks 48.6 coordinates Research block 48.6_2 coordinates 54\u00b0 00' S 01\u00b0 00' E 55\u00b0 00' S 01\u00b0 00' E 55\u00b0 00' S 02\u00b0 00' E 55\u00b0 30' S 02\u00b0 00' E 55\u00b0 30' S 04\u00b0 00' E 56\u00b0 30' S 04\u00b0 00' E 56\u00b0 30' S 07\u00b0 00' E 56\u00b0 00' S 07\u00b0 00' E 56\u00b0 00' S 08\u00b0 00' E 54\u00b0 00' S 08\u00b0 00' E 54\u00b0 00' S 09\u00b0 00' E 53\u00b0 00' S 09\u00b0 00' E 53\u00b0 00' S 03\u00b0 00' E 53\u00b0 30' S 03\u00b0 00' E 53\u00b0 30' S 02\u00b0 00' E 54\u00b0 00' S 02\u00b0 00' E Research block 48.6_3 coordinates 64\u00b0 30' S 01\u00b0 00' E 66\u00b0 00' S 01\u00b0 00' E 66\u00b0 00' S 04\u00b0 00' E 65\u00b0 00' S 04\u00b0 00' E 65\u00b0 00' S 07\u00b0 00' E 64\u00b0 30' S 07\u00b0 00' E Research block 48.6_4 coordinates 68\u00b0 20' S 10\u00b0 00' E 68\u00b0 20' S 13\u00b0 00' E 69\u00b0 30' S 13\u00b0 00' E 69\u00b0 30' S 10\u00b0 00' E 69\u00b0 45' S 10\u00b0 00' E 69\u00b0 45' S 06\u00b0 00' E 69\u00b0 00' S 06\u00b0 00' E 69\u00b0 00' S 10\u00b0 00' E Research block 48.6_5 coordinates 71\u00b0 00' S 15\u00b0 00' W 71\u00b0 00' S 13\u00b0 00' W 70\u00b0 30' S 13\u00b0 00' W 70\u00b0 30' S 11\u00b0 00' W 70\u00b0 30' S 10\u00b0 00' W 69\u00b0 30' S 10\u00b0 00' W 69\u00b0 30' S 09\u00b0 00' W 70\u00b0 00' S 09\u00b0 00' W 70\u00b0 00' S 08\u00b0 00' W 69\u00b0 30' S 08\u00b0 00' W 69\u00b0 30' S 07\u00b0 00' W 70\u00b0 30' S 07\u00b0 00' W 70\u00b0 30' S 10\u00b0 00' W 71\u00b0 00' S 10\u00b0 00' W 71\u00b0 00' S 11\u00b0 00' W 71\u00b0 30' S 11\u00b0 00' W 71\u00b0 30' S 15\u00b0 00' W List of small-scale research units (SSRUs) Region SSRU Boundary line 88.1 A From 60\u00b0 S 150\u00b0 E, due east to 170\u00b0 E, due south to 65\u00b0 S, due west to 150\u00b0 E, due north to 60\u00b0 S. B From 60\u00b0 S 170\u00b0 E, due east to 179\u00b0 E, due south to 66\u00b040' S, due west to 170\u00b0 E, due north to 60\u00b0 S. C From 60\u00b0 S 179\u00b0 E, due east to 170\u00b0 W, due south to 70\u00b0 S, due west to 178\u00b0 W, due north to 66\u00b040' S, due west to 179\u00b0 E, due north to 60\u00b0 S. D From 65\u00b0 S 150\u00b0 E, due east to 160\u00b0 E, due south to coast, westward along coast to 150\u00b0 E, due north to 65\u00b0 S. E From 65\u00b0 S 160\u00b0 E, due east to 170\u00b0 E, due south to 68\u00b0 30' S, due west to 160\u00b0 E, due north to 65\u00b0 S. F From 68\u00b0 30' S 160\u00b0 E, due east to 170\u00b0 E, due south to coast, westward along coast to 160\u00b0 E, due north to 68\u00b0 30' S. G From 66\u00b0 40' S 170\u00b0 E, due east to 178\u00b0 W, due south to 70\u00b0 S, due west to 178\u00b0 50' E, due south to 70\u00b0 50' S, due west to 170\u00b0 E, due north to 66\u00b040' S. H From 70\u00b0 50' S 170\u00b0 E, due east to 178\u00b0 50' E, due south to 73\u00b0 S, due west to coast, northward along coast to 170\u00b0 E, due north to 70\u00b0 50' S. I From 70\u00b0 S 178\u00b0 50' E, due east to 170\u00b0 W, due south to 73\u00b0 S, due west to 178\u00b0 50' E, due north to 70\u00b0 S. J From 73\u00b0 S at coast near 170\u00b0 E, due east to 178\u00b0 50' E, due south to 80\u00b0 S, due west to 170\u00b0 E, northward along coast to 73\u00b0 S. K From 73\u00b0 S 178\u00b0 50' E, due east to 170\u00b0 W, due south to 76\u00b0 S, due west to 178\u00b0 50' E, due north to 73\u00b0 S. L From 76\u00b0 S 178\u00b0 50' E, due east to 170\u00b0 W, due south to 80\u00b0 S, due west to 178\u00b0 50' E, due north to 76\u00b0 S. M From 73\u00b0 S at coast near 169\u00b0 30' E, due east to 170\u00b0 E, due south to 80\u00b0 S, due west to coast, northward along coast to 73\u00b0 S. PART B NOTIFICATION OF INTENT TO PARTICIPATE IN A FISHERY FOR EUPHAUSIA SUPERBA General information Member: \u2026 Fishing season: \u2026 Name of vessel: \u2026 Expected level of catch (tonnes): \u2026 Vessel\u2019s daily processing capacity (tonnes in green weight): \u2026 Intended fishing subareas and divisions This conservation measure applies to notifications of intentions to fish for krill in Subareas 48.1, 48.2, 48.3 and 48.4 and Divisions 58.4.1 and 58.4.2. Intentions to fish for krill in other subareas and divisions must be notified under Conservation Measure 21-02. Subarea/division Tick the appropriate boxes 48.1 \u25a1 48.2 \u25a1 48.3 \u25a1 48.4 \u25a1 58.4.1 \u25a1 58.4.2 \u25a1 Fishing technique : Tick the appropriate boxes \u25a1 Conventional trawl \u25a1 Continuous fishing system \u25a1 Pumping to clear cod-end \u25a1 Other method (please specify) Product types and methods for direct estimation of green weight of krill caught Product type Method for direct estimation of green weight of krill caught, where relevant (refer to Annex 21-03/B) (1) Whole frozen Boiled Meal Oil Other product (please specify) Net configuration Net measurements Net 1 Net 2 Other net(s) Net opening (mouth) Maximum vertical opening (m) Maximum horizontal opening (m) Net circumference at mouth (2) (m) Mouth area (m2) Panel average mesh size (4) (mm) Outer (3) Inner (3) Outer (3) Inner (3) Outer (3) Inner (3) 1st panel 2nd panel 3rd panel \u2026 Final panel (cod-end) Net diagram(s): \u2026 For each net used, or any change in net configuration, refer to the relevant net diagram in the CCAMLR fishing gear library if available (www.ccamlr.org/node/74407), or submit a detailed diagram and description to the forthcoming meeting of WG-EMM. Net diagram(s) must include: 1. Length and width of each trawl panel (in sufficient detail to allow calculation of the angle of each panel with respect to water flow). 2. Mesh size (inside measurement of stretched mesh based on the procedure in Conservation Measure 22-01), shape (e.g. diamond shape) and material (e.g. polypropylene). 3. Mesh construction (e.g. knotted, fused). 4. Details of streamers used inside the trawl (design, location on panels, indicate \u2018nil\u2019 if streamers are not in use); streamers prevent krill fouling the mesh or escaping. Marine mammal exclusion device Device diagram(s): \u2026 For each type of device used, or any change in device configuration, refer to the relevant diagram in the CCAMLR fishing gear library if available (www.ccamlr.org/node/74407), or submit a detailed diagram and description to the forthcoming meeting of WG-EMM. Collection of acoustic data Provide information on the echosounders and sonars used by the vessel Type (e.g. echosounder, sonar) Manufacturer Model Transducer frequencies (kHz) Collection of acoustic data (detailed description): \u2026 Outline steps which will be taken to collect acoustic data to provide information on the distribution and abundance of Euphausia superba and other pelagic species such as myctophids and salps (SC-CAMLR-XXX, paragraph 2.10). GUIDELINES FOR ESTIMATING THE GREEN WEIGHT OF KRILL CAUGHT Method Equation (kg) Parameter Description Type Estimation method Unit Holding tank volume W*L*H*\u03c1*1 000 W = tank width Constant Measure at the start of fishing m L = tank length Constant Measure at the start of fishing m \u03c1 = volume-to-mass conversion factor Variable Volume-to-mass conversion kg/litre H = depth of krill in tank Haul-specific Direct observation m Flow meter (5) V*Fkrill*\u03c1 V = volume of krill and water combined Haul (5)-specific Direct observation litre Fkrill = fraction of krill in the sample Haul (5)-specific Flow meter volume correction \u2014 \u03c1 = volume-to-mass conversion factor Variable Volume-to-mass conversion kg/litre Flow meter (6) (V*\u03c1)\u2013M V = volume of krill paste Haul (5)-specific Direct observation litre M = amount of water added to the process, converted to mass Haul (5)-specific Direct observation kg \u03c1 = density of krill paste Variable Direct observation kg/litre Flow scale M*(1\u2013F) M = mass of krill and water combined Haul (6)-specific Direct observation kg F = fraction of water in the sample Variable Flow scale mass correction \u2014 Plate tray (M\u2013Mtray)*N Mtray = mass of empty tray Constant Direct observation prior to fishing kg M = mean mass of krill and tray combined Variable Direct observation, prior to freezing with water drained kg N = number of trays Haul-specific Direct observation \u2014 Meal conversion Mmeal*MCF Mmeal = mass of meal produced Haul-specific Direct observation kg MCF = meal conversion factor Variable Meal to whole krill conversion \u2014 Cod-end volume W*H*L*\u03c1*\u03c0/4*1 000 W = cod-end width Constant Measure at the start of fishing m H = cod-end height Constant Measure at the start of fishing m \u03c1 = volume-to-mass conversion factor Variable Volume-to-mass conversion kg/litre L = cod-end length Haul-specific Direct observation m Other Please specify Observation steps and frequency Holding tank volume At the start of fishing Measure the width and length of the holding tank (if the tank is not rectangular in shape, then additional measurements may be required; precision \u00b10,05 m) Every month (7) Estimate the volume-to-mass conversion derived from the drained mass of krill in a known volume (e.g. 10 litres) taken from the holding tank Every haul Measure the depth of krill in the tank (if krill are held in the tank between hauls, then measure the difference in depth; precision \u00b10,1 m) Estimate the green weight of krill caught (using equation) Flow meter (7) Prior to fishing Ensure that the flow meter is measuring whole krill (i.e. prior to processing) More than once per month (7) Estimate the volume-to-mass conversion (\u03c1) derived from the drained mass of krill in a known volume (e.g. 10 litres) taken from the flow meter Every haul (8) Obtain a sample from the flow meter and: measure the volume (e.g. 10 litres) of krill and water combined estimate the flow meter volume correction derived from the drained volume of krill Estimate the green weight of krill caught (using equation) Flow meter (8) Prior to fishing Ensure that both flow meters (one for the krill product and one for the water added) are calibrated (i.e. show the same, correct reading) Every week (7) Estimate the density (\u03c1) of the krill product (ground krill paste) by measuring the mass of a known volume of krill product (e.g. 10 litres) taken from the corresponding flow meter Every haul (8) Read both flow meters, and calculate the total volumes of the krill product (ground krill paste) and that of the water added; density of the water is assumed to be 1 kg/litre Estimate the green weight of krill caught (using equation) Flow scale Prior to fishing Ensure that the flow scale is measuring whole krill (i.e. prior to processing) Every haul (8) Obtain a sample from the flow scale and: measure the mass of krill and water combined estimate the flow scale mass correction derived from the drained mass of krill Estimate the green weight of krill caught (using equation) Plate tray Prior to fishing Measure the mass of the tray (if trays vary in design, then measure the mass of each type; precision \u00b10,1 kg) Every haul Measure the mass of krill and tray combined (precision \u00b10,1 kg) Count the number of trays used (if trays vary in design, then count the number of trays of each type) Estimate the green weight of krill caught (using equation) Meal conversion Every month (7) Estimate the meal to whole krill conversion by processing 1 000 to 5 000 kg (drained mass) of whole krill Every haul Measure the mass of meal produced Estimate the green weight of krill caught (using equation) Cod-end volume At the start of fishing Measure the width and height of the cod-end (precision \u00b10,1 m) Every month (7) Estimate the volume-to-mass conversion derived from the drained mass of krill in a known volume (e.g. 10 litres) taken from the cod-end Every haul Measure the length of cod-end containing krill (precision \u00b10,1 m) Estimate the green weight of krill caught (using equation) (1) If the method is not listed in Annex 21-03/B, then please describe in detail. (2) Expected in operational conditions. (3) Size of outer mesh, and inner mesh where a liner is used. (4) Inside measurement of stretched mesh based on the procedure in Conservation Measure 22-01. (5) Individual haul when using a conventional trawl, or integrated over a six-hour period when using the continuous fishing system. (6) Individual haul when using a conventional trawl, or a two-hour period when using the continuous fishing system. (7) A new period will commence when the vessel moves to a new subarea or division. (8) Individual haul when using a conventional trawl, or integrated over a six-hour period when using the continuous fishing system. ANNEX VIII IOTC AREA OF COMPETENCE 1. Maximum number of Union fishing vessels authorised to fish for tropical tunas in the IOTC Area of Competence Member State Maximum number of vessels Capacity (gross tonnage) Spain 22 61 364 France 27 45 383 Portugal 5 1 627 Italy 1 2 137 Union 55 110 511 2. Maximum number of Union fishing vessels authorised to fish for swordfish and albacore in the IOTC Area of Competence Member State Maximum number of vessels Capacity (gross tonnage) Spain 27 11 590 France 41 (1) 7 882 Portugal 15 6 925 United Kingdom 4 1 400 Union 87 27 797 3. The vessels referred to in point 1 shall also be authorised to fish for swordfish and albacore in the IOTC Area of Competence. 4. The vessels referred to in point 2 shall also be authorised to fish for tropical tunas in the IOTC Area of Competence. (1) This figure does not include vessels registered in Mayotte; it may be increased in the future in accordance with Mayotte\u2019s fleet development plan. ANNEX IX WCPFC CONVENTION AREA Maximum number of Union fishing vessels authorised to fish for swordfish in areas south of 20\u00b0S of the WCPFC Convention Area Spain 14 Union 14 Maximum number of Union purse seiners authorised to fish for tropical tuna in areas south of 20\u00b0S of the WCPFC Convention Area Spain 4 Union 4", "summary": "Fishing opportunities in EU and non-EU waters (2020) Fishing opportunities in EU and non-EU waters (2020) SUMMARY OF: Regulation (EU) 2020/123 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters Regulation (EU) 2019/2236 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Mediterranean and Black Seas Regulation (EU) 2019/1838 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Baltic Sea and amending Regulation (EU) 2019/124 as regards certain fishing opportunities in other waters WHAT IS THE AIM OF THE REGULATIONS? The regulations set yearly total allowable catches (TACs)* and quotas* by fish stocks, as well as fishing effort levels in the different fishing areas in line with the objectives of the EU\u2019s common fisheries policy \u2014 environmental and socioeconomic sustainability \u2014 to the benefit of the fish stocks, fishing sector and EU citizens. KEY POINTS The regulations apply to EU fishing vessels and non-EU vessels in EU waters and some recreational fisheries*. Regulation (EU) 2020/123 sets 2020 catch limits for the main commercial fish stocks in the Atlantic, the North Sea and some other international fisheries in which EU vessels participate. The limits generally apply for the 2020 calendar year, but some extend into 2021 or apply for slightly different periods. The regulation includes rules on: TACs and allocations among EU countries; Conditions for landing catches and by-catches, including which species may be retained on board or landed, aiming to continue to reduce unwanted catches through the landing obligation (i.e. the prohibition to discard certain stocks at sea) for all stocks under catch limit; Quota-exchange mechanism for TACs for unavoidable by-catches*; Slightly increased by-catch levels for seabass in the Northern areas and additional flexibility in their management; Measures on European eel fisheries in EU waters; Special provisions on allocations of fishing opportunities to EU countries, such as exchanges and quota transfers; Remedial measures for cod and whiting in the Celtic Sea, North Sea and Kattegat, with the aim of improving the selectivity of fishing gears and reducing by-catches; Prohibited species; Closed fishing seasons; Recreational fisheries; Sharks: retaining on board, transshipping* or landing is generally prohibited, and if caught accidentally must be promptly released. The regulation also covers Fishing authorisations in non-EU waters; Fishing opportunities for non-EU vessels in EU waters. Regulation (EU) 2019/2236 fixes for 2020 the fishing opportunities in the Mediterranean and Black Seas for the following fish stocks.The rules include: A fishing effort regime in the Western Mediterranean applying to Spain, France and Italy; A closure period for European eel in the entire Mediterranean Sea; Catch and effort limits for small pelagic stocks and an effort limit for demersal stocks in the Adriatic Sea; An autonomous quota for sprat in the Black Sea applying to Bulgaria and Romania; A TAC for turbot in the Black Sea, as well as closure periods and a fishing effort regime. Regulation (EU) 2019/1838 fixes fishing opportunities for certain fish stocks in the Baltic Sea for 2020 and amends some fishing opportunities in other waters fixed by Regulation (EU) 2019/124. It covers: TACs and national quotas for the ten most commercially important fish stocks in the Baltic Sea and how much European fishermen will be able to fish and under what conditions; Decreased fishing opportunities for the majority of fish stocks; Moderately increased TACs only for herring in the Gulf of Riga; TACs maintained for salmon in the Gulf of Finland; particularly significant cuts for cod, with a 60% decrease in the Western part of the Baltic Sea, and a TAC for by-catches only in the Eastern part; Additional remedial measures on cod stocks, including stricter limits for recreational fisheries (normally a bag limit of five specimens per fisherman per day) and longer closure periods in some geographical subdivisions. WHEN DO THE REGULATIONS APPLY? They apply from 1 January 2020 to 31 December 2020 with some minor exceptions. BACKGROUND For more information, see: The Common Fisheries Policy (CFP) (European Commission) Management of the EU\u2019s fish stocks (Council of the European Union) Managing fisheries (European Commission) Fishing quotas (European Commission). KEY TERMS Total allowable catch (TAC): the quantity of each type of fish that can be caught over the period of a year. Quota: a proportion of the TAC allocated to the EU, an EU country or a non-EU country. Recreational fisheries: non-commercial fishing activities exploiting marine biological resources such as for recreation, tourism or sport. By-catch: unwanted fish and marine species caught unintentionally. Transshipment: the transfer of a catch from a smaller fishing boat to a larger one which then incorporates it into a larger batch for shipment. MAIN DOCUMENTS Council Regulation (EU) 2020/123 of 27 January 2020 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters (OJ L 25, 30.1.2020, pp. 1-156) Successive amendments to Regulation (EU) 2020/123 have been incorporated into the original text. This consolidated version is of documentary value only. Council Regulation (EU) 2019/2236 of 16 December 2019 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Mediterranean and Black Seas (OJ L 336, 30.12.2019, pp. 14-25) Council Regulation (EU) 2019/1838 of 30 October 2019 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Baltic Sea and amending Regulation (EU) 2019/124 as regards certain fishing opportunities in other waters (OJ L 281, 31.10.2019, pp. 1-14) See consolidated version. RELATED DOCUMENTS Communication from the Commission to the European Parliament and the Council on the State of Play of the Common Fisheries Policy and Consultation on the Fishing Opportunities for 2020 (COM(2019) 274 final, 7.6.2019) Council Regulation (EU) 2019/124 of 30 January 2019 fixing for 2019 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters (OJ L 29, 31.1.2019, pp. 1-166) See consolidated version. last update 03.06.2020"}
{"article": "28.2.2022 EN Official Journal of the European Union L 55/4 DECISION (EU) 2022/313 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 February 2022 providing macro-financial assistance to Ukraine THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 212 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Relations between the European Union (the \u2018Union\u2019) and Ukraine continue to develop within the framework of the European Neighbourhood Policy (ENP) and the Eastern Partnership. An association agreement between the Union and Ukraine (2) (the \u2018Association Agreement\u2019), including a Deep and Comprehensive Free Trade Area (DCFTA), entered into force on 1 September 2017. (2) In spring 2014, Ukraine embarked on an ambitious reform programme with the aim of stabilising its economy and improving the livelihoods of its citizens. The fight against corruption as well as constitutional, electoral and judicial reforms are among the top priorities on the agenda. The implementation of those reforms was supported by five consecutive macro-financial assistance programmes, under which Ukraine has received assistance in the form of loans for a total of EUR 5 billion. The latest macro-financial assistance, which was made available in the context of the COVID-19 pandemic pursuant to Decision (EU) 2020/701 of the European Parliament and of the Council (3), provided EUR 1,2 billion in loans to Ukraine and was completed in September 2021. (3) The economy of Ukraine has been affected by the recession in 2020, which was caused by the COVID-19 pandemic and by prolonged security threats at its border with Russia. The continuous build-up of uncertainty has resulted in a recent loss of confidence, negatively affecting the economic outlook, and, since mid-January 2022, in the loss of access to international capital markets. The deteriorating financing conditions have contributed to a sizable and increasing residual external financing gap and weigh heavily on investment, thereby weakening Ukraine\u2019s resilience to future economic and political shocks. (4) The Ukrainian government has demonstrated a strong commitment to implement further reforms focusing, at the current critical juncture, in the short term on key policy areas such as economic resilience and stability, governance and rule of law, and energy. (5) A renewed commitment to carry out such reforms and a strong political will has led the Ukranian authorities to accelerate the implementation of reforms since the summer of 2021. This has also enabled Ukraine to successfully complete the macro-financial assistance operation in the context of the COVID-19 pandemic, as all reform actions agreed with the Union in the Memorandum of Understanding were fulfilled. (6) To allow for more policy flexibility in the context of the crisis related to the COVID-19 pandemic, the International Monetary Fund (IMF) approved an 18-month Stand-by Arrangement for Ukraine with access equivalent to USD 5 billion in June 2020. That arrangement focuses on four priorities: (i) mitigating the economic impact of the crisis, including by supporting households and businesses; (ii) ensuring continued central bank independence and a flexible exchange rate; (iii) safeguarding financial stability while recovering the costs from bank resolutions; and (iv) moving forward with key governance and anti-corruption measures to preserve and deepen recent gains. Due to an uneven implementation record, the first programme review, which also agreed on an extension of the programme until the end of June 2022, was not concluded until November 2021. This brought total disbursements under the current IMF programme to the equivalent of USD 2,8 billion thus far. Two more reviews are planned to take place by the end of the second quarter of 2022. (7) In view of high budget financing risks and in the context of a slow recovery from the crisis related to the COVID-19 pandemic and quickly accelerating inflation, Ukraine requested a new long-term macro-financial assistance programme for up to EUR 2,5 billion from the Union on 16 November 2021. Such emergency macro-financial assistance responds, in particular, to the sharp and unexpected increase in the external financing needs of Ukraine, triggered by the de facto loss of access to financial markets, and to the underlying immediate challenges. (8) Given that Ukraine is a country covered by the ENP, it should be considered to be eligible to receive macro-financial assistance from the Union. (9) The Union\u2019s macro-financial assistance should be an exceptional financial instrument of untied and undesignated balance-of-payments support, which aims to address the beneficiary\u2019s immediate external financing needs and should underpin the implementation of a policy programme containing strong immediate adjustment and structural reform measures designed to improve the beneficiary\u2019s balance-of-payments position in the short term and economic resilience in the medium term. (10) Given that the loss of market access and the capital outflow have created a significant residual external financing gap in Ukraine\u2019s balance of payments over and above the resources provided by the IMF and other multilateral institutions, the swift provision by the Union of emergency macro-financial assistance to Ukraine is, under the current exceptional circumstances, considered to be an appropriate short-term response to the sizeable risks to the country. The Union\u2019s macro-financial assistance would support Ukraine\u2019s economic stabilisation and aim to strengthen the immediate resilience of the country, as well as and where feasible at present, strengthen the structural reform agenda of Ukraine, supplementing resources made available under the IMF\u2019s financial arrangement. (11) The Union\u2019s macro-financial assistance should aim to support the restoration of a sustainable external financing situation for Ukraine, thereby supporting its economic and social development. (12) The Union\u2019s macro-financial assistance is expected to go hand-in-hand with the implementation of budget support operations under the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe, established by Regulation (EU) 2021/947 of the European Parliament and of the Council (4). (13) The determination of the amount of the Union\u2019s macro-financial assistance is based on a quantitative assessment of Ukraine\u2019s residual external financing needs, and takes into account its capacity to finance itself with its own resources, in particular the international reserves at its disposal. The Union\u2019s macro-financial assistance should complement the programmes and resources provided by the IMF and the World Bank. The determination of the amount of the assistance also takes into account expected financial contributions from multilateral donors and the need to ensure fair burden sharing between the Union and other donors, as well as the pre-existing deployment of the Union\u2019s other external financing instruments in Ukraine and the added value of the overall Union involvement. (14) The Commission should ensure that the Union\u2019s macro-financial assistance is legally and substantially in accordance with the key principles and objectives of, and the measures taken within the different areas of external action and other relevant Union policies. (15) The Union\u2019s macro-financial assistance should support the Union\u2019s external policy towards Ukraine. The Commission and the European External Action Service should work closely together throughout the macro-financial assistance operation in order to coordinate, and ensure the consistency of, Union external policy. (16) The Union\u2019s macro-financial assistance should support Ukraine\u2019s commitment to values shared with the Union, including democracy, the rule of law, good governance, respect for human rights, sustainable development and poverty reduction, as well as its commitment to the principles of open, rule-based and fair trade. (17) A precondition for granting the Union\u2019s macro-financial assistance should be that Ukraine respects effective democratic mechanisms, including a multi-party parliamentary system, and the rule of law, and guarantees respect for human rights. In addition, the specific objectives of the Union\u2019s macro-financial assistance should strengthen the efficiency, transparency and accountability of the public finance management systems and should promote structural reforms aimed at supporting sustainable and inclusive growth, decent employment creation and fiscal consolidation. The Commission and the European External Action Service should regularly monitor both the fulfilment of the precondition and the achievement of those objectives. (18) In order to ensure that the Union\u2019s financial interests linked to the Union\u2019s macro-financial assistance are protected efficiently, Ukraine should take appropriate measures relating to the prevention of, and fight against, fraud, corruption and any other irregularities linked to that assistance. In addition, provision should be made for the Commission to carry out checks, for the Court of Auditors to carry out audits and for the European Public Prosecutor\u2019s Office to exercise its competences. (19) Release of the Union\u2019s macro-financial assistance is without prejudice to the powers of the European Parliament and the Council as budgetary authority. (20) The amounts of provisioning required for the Union\u2019s macro-financial assistance should be consistent with the budgetary appropriations provided for in the multiannual financial framework. (21) The Union\u2019s macro-financial assistance should be managed by the Commission. In order to ensure that the European Parliament and the Council are able to follow the implementation of this Decision, the Commission should regularly inform them of developments relating to that assistance and provide them with the relevant documents. (22) In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (5). (23) The Union\u2019s macro-financial assistance should be subject to economic policy conditions, to be set out in a memorandum of understanding (MOU). In order to ensure uniform conditions of implementation and for reasons of efficiency, the Commission should be empowered to negotiate such conditions with the Ukrainian authorities under the supervision of the committee of representatives of the Member States in accordance with Regulation (EU) No 182/2011. Under that Regulation, the advisory procedure should, as a general rule, apply in all cases other than as provided for in that Regulation. Considering the potentially significant impact of assistance of more than EUR 90 million, it is appropriate that the examination procedure as specified in Regulation (EU) No 182/2011 be used for operations above that threshold. Considering the amount of the Union\u2019s macro-financial assistance to Ukraine, the examination procedure should apply to the adoption of the MOU, and to any reduction, suspension or cancellation of the assistance. (24) Since the objective of this Decision, namely to provide emergency macro-financial assistance to Ukraine with a view to supporting, in particular, its economic resilience and stability, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary to achieve that objective. (25) In view of the urgency entailed by the exceptional circumstances caused by the COVID-19 pandemic and the associated economic consequences, it is considered to be appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the TEU, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community. (26) In order to allow for the prompt application of measures laid down in this Decision, this Decision should enter into force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS DECISION: Article 1 1. The Union shall make macro-financial assistance of a maximum amount of EUR 1,2 billion available to Ukraine (the \u2018Union\u2019s macro-financial assistance\u2019), with a view to supporting Ukraine\u2019s economic stabilisation and substantive reform agenda. The full amount of the Union\u2019s macro-financial assistance shall be provided to Ukraine in the form of loans. The release of the Union\u2019s macro-financial assistance is subject to the approval of the Union budget for the relevant year by the European Parliament and the Council. The assistance shall contribute to covering Ukraine\u2019s balance-of-payments needs as identified in the IMF programme. 2. In order to finance the Union\u2019s macro-financial assistance, the Commission shall be empowered, on behalf of the Union, to borrow the necessary funds on the capital markets or from financial institutions and to on-lend them to Ukraine. The loans shall have a maximum average maturity of 15 years. 3. The release of the Union\u2019s macro-financial assistance shall be managed by the Commission in a manner consistent with the agreements or understandings reached between the IMF and Ukraine, and with the key principles and objectives of economic reforms set out in the Association Agreement, including the DCFTA, agreed under the ENP. The Commission shall regularly inform the European Parliament and the Council of developments regarding the Union\u2019s macro-financial assistance, including disbursements thereof, and shall provide those institutions with the relevant documents in due time. 4. The Union\u2019s macro-financial assistance shall be made available for a period of 12 months, starting on the first day after the entry into force of the MOU referred to in Article 3(1). 5. If the financing needs of Ukraine decrease fundamentally during the period of the disbursement of the Union\u2019s macro-financial assistance compared to the initial projections, the Commission, acting in accordance with the examination procedure referred to in Article 7(2), shall reduce the amount of the assistance or suspend or cancel it. Article 2 1. A precondition for granting the Union\u2019s macro-financial assistance shall be that Ukraine respects effective democratic mechanisms, including a multi-party parliamentary system, and the rule of law, and guarantees respect for human rights. 2. The Commission and the European External Action Service shall monitor the fulfilment of the precondition set out in paragraph 1 throughout the life-cycle of the Union\u2019s macro-financial assistance. 3. Paragraphs 1 and 2 of this Article shall apply in accordance with Council Decision 2010/427/EU (6). Article 3 1. The Commission, in accordance with the examination procedure referred to in Article 7(2), shall agree with the Ukrainian authorities on clearly defined economic policy and financial conditions, focusing on structural reforms and sound public finances, to which the Union\u2019s macro-financial assistance is to be subject. Those economic policy and financial conditions shall be set out in a MOU which shall include a timeframe for the fulfilment of those conditions. The economic policy and financial conditions set out in the MOU shall be consistent with the agreements or understandings referred to in Article 1(3), including the macroeconomic adjustment and structural reform programmes implemented by Ukraine with the support of the IMF. 2. The conditions referred to in paragraph 1 shall aim, in particular, to enhance the efficiency, transparency and accountability of the public finance management systems in Ukraine, including for the use of the Union\u2019s macro-financial assistance. Progress in mutual market opening, the development of rule-based and fair trade, and other priorities in the context of the Union\u2019s external policy shall also be duly taken into account when designing the policy measures. The Commission shall regularly monitor the progress in attaining those objectives. 3. The detailed financial terms of the Union\u2019s macro-financial assistance shall be laid down in a loan agreement to be concluded between the Commission and Ukraine. 4. The Commission shall verify, at regular intervals, that the conditions referred to in Article 4(3) continue to be met, including whether the economic policies of Ukraine are in accordance with the objectives of the Union\u2019s macro-financial assistance. For the purposes of that verification, the Commission shall coordinate closely with the IMF and the World Bank, and, where necessary, with the European Parliament and with the Council. Article 4 1. Subject to the conditions referred to in paragraph 3, the Union\u2019s macro-financial assistance shall be made available by the Commission in two equal instalments, each of which shall consist of a loan. The timeframe for the disbursement of each instalment shall be laid down in the MOU. 2. The amounts of the Union\u2019s macro-financial assistance provided in the form of loans shall be provisioned, where required, in accordance with Regulation (EU) 2021/947. 3. The Commission shall decide on the release of the instalments, subject to the fulfilment of the following conditions: (a) the precondition set out in Article 2(1); (b) a continuous satisfactory track record of implementing a non-precautionary IMF credit arrangement; (c) the satisfactory implementation of the economic policy and financial conditions agreed in the MOU. The release of the second instalment shall not, in principle, take place earlier than three months after the release of the first instalment. 4. Where the conditions referred to in paragraph 3, first subparagraph, are not met, the Commission shall temporarily suspend or cancel the disbursement of the Union\u2019s macro-financial assistance. In such cases, it shall inform the European Parliament and the Council of the reasons for the suspension or cancellation. 5. The Union\u2019s macro-financial assistance shall be disbursed to the National Bank of Ukraine. Subject to the provisions to be agreed in the MOU, including a confirmation of residual budgetary financing needs, the Union funds may be transferred to the Ukrainian Ministry of Finance as the final beneficiary. Article 5 1. The borrowing and lending operations related to the Union\u2019s macro-financial assistance shall be carried out in euro using the same value date and shall not involve the Union in the transformation of maturities, or expose the Union to any exchange or interest rate risk, or to any other commercial risk. 2. Where the circumstances permit, and if Ukraine so requests, the Commission may take the steps necessary to ensure that an early repayment clause is included in the loan terms and conditions and that it is matched by a corresponding clause in the terms and conditions of the borrowing operations. 3. Where circumstances permit an improvement of the interest rate of the loan and if Ukraine so requests, the Commission may decide to refinance all or part of its initial borrowings or may restructure the corresponding financial conditions. Refinancing or restructuring operations shall be carried out in accordance with paragraphs 1 and 4 and shall not have the effect of extending the maturity of the borrowings concerned or of increasing the amount of capital outstanding at the date of the refinancing or restructuring. 4. All costs incurred by the Union which relate to the borrowing and lending operations under this Decision shall be borne by Ukraine. 5. The Commission shall inform the European Parliament and the Council of developments in the operations referred to in paragraphs 2 and 3. Article 6 1. The Union\u2019s macro-financial assistance shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (7). 2. The Union\u2019s macro-financial assistance shall be implemented under direct management. 3. The loan agreement referred to in Article 3(3) shall contain all of the following provisions: (a) ensuring that Ukraine regularly checks that financing provided from the general budget of the Union has been properly used, takes appropriate measures to prevent irregularities and fraud, and, if necessary, takes legal action to recover any funds provided under this Decision that have been misappropriated; (b) ensuring the protection of the Union\u2019s financial interests, in particular providing for specific measures in relation to the prevention of, and fight against, fraud, corruption and any other irregularities affecting the Union\u2019s macro-financial assistance, in accordance with Council Regulations (EC, Euratom) No 2988/95 (8) and (Euratom, EC) No 2185/96 (9), Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (10) and, for those Member States participating in enhanced cooperation regarding the European Public Prosecutor\u2019s Office, Council Regulation (EU) 2017/1939 (11); (c) expressly authorising the European Anti-Fraud Office to carry out investigations, including on-the-spot checks and inspections including digital forensic operations and interviews; (d) expressly authorising the Commission, or its representatives, to carry out checks, including on-the-spot checks and inspections; (e) expressly authorising the Commission and the Court of Auditors to perform audits during and after the availability period of the Union\u2019s macro-financial assistance, including document audits and on-the-spot audits, such as operational assessments; (f) ensuring that the Union is entitled to early repayment of the loan where it has been established that, in relation to the management of the Union\u2019s macro-financial assistance, Ukraine has engaged in any act of fraud or corruption or any other illegal activity detrimental to the financial interests of the Union; (g) ensuring that all costs incurred by the Union that relate to the borrowing and lending operations under this Decision are to be borne by Ukraine. 4. Before the implementation of the Union\u2019s macro-financial assistance, the Commission shall assess, by means of an operational assessment, the soundness of Ukraine\u2019s financial arrangements, the administrative procedures, and the internal and external control mechanisms which are relevant to the assistance. Article 7 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 8 1. By 30 June of each year, the Commission shall submit to the European Parliament and to the Council a report on the implementation of this Decision in the preceding year, including an evaluation of that implementation. That report shall: (a) examine the progress made in implementing the Union\u2019s macro-financial assistance; (b) assess the economic situation and prospects of Ukraine, as well as the progress made in implementing the policy measures referred to in Article 3(1); (c) indicate the connection between the economic policy conditions set out in the MOU, Ukraine\u2019s ongoing economic and fiscal performance and the Commission\u2019s decisions to release the instalments of the Union\u2019s macro-financial assistance. 2. Not later than two years after the expiry of the availability period referred to in Article 1(4), the Commission shall submit to the European Parliament and to the Council an ex-post evaluation report, assessing the results and efficiency of the completed Union\u2019s macro-financial assistance and the extent to which it has contributed to the aims of the assistance. Article 9 This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union. Done at Brussels, 24 February 2022. For the European Parliament The President R. METSOLA For the Council The President A. PANNIER-RUNACHER (1) Position of the European Parliament of 16 February 2022 (not yet published in the Official Journal) and decision of the Council of 21 February 2022. (2) Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part (OJ L 161, 29.5.2014, p. 3). (3) Decision (EU) 2020/701 of the European Parliament and of the Council of 25 May 2020 on providing macro-financial assistance to enlargement and neighbourhood partners in the context of the COVID-19 pandemic (OJ L 165, 27.5.2020, p. 31). (4) Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009 (OJ L 209, 14.6.2021, p. 1). (5) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (6) Council Decision 2010/427/EU of 26 July 2010 establishing the organisation and functioning of the European External Action Service (OJ L 201, 3.8.2010, p. 30). (7) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (8) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (9) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (10) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (11) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1).", "summary": "Macro-financial assistance to Ukraine Macro-financial assistance to Ukraine SUMMARY OF: Decision (EU) 2022/313 providing macro-financial assistance to Ukraine WHAT IS THE AIM OF THE DECISION? It aims to provide swift financial support to Ukraine to strengthen its resilience and stability in the face of current economic and geopolitical challenges, in the context of the Russian aggression against Ukraine. KEY POINTS EU-Ukraine relations The European Union (EU) develops its relations with Ukraine through the European neighbourhood policy and the Eastern Partnership. An association agreement between the two parties, including a deep and comprehensive free trade area, came into force in 2017. Macro-financial assistance Macro-financial assistance (MFA) operations are available to EU neighbourhood countries experiencing severe balance-of-payments problems. They aim to address the beneficiary\u2019s immediate external financing needs and underpin the implementation of economic policy reforms. The EU\u2019s macro-financial assistance is expected to work alongside the implementation of budget support operations under the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe set out in Regulation (EU) 2021/947 (see summary). MFA to Ukraine The EU will make \u20ac1.2 billion available to Ukraine to support economic stabilisation and its reform agenda. It will provide the full amount in loans. The decision grants the European Commission the power to borrow the necessary funds on the capital markets or from financial institutions on behalf of the EU and to lend these funds on to Ukraine. The loans will have a maximum average maturity of 15 years. The Commission will manage the release of the MFA. The funds will be released to Ukraine over a period of 12 months. As a precondition, Ukraine must respect democratic mechanisms, the rule of law and human rights. The MFA will be made available in two equal instalments of \u20ac600 million:the first instalment to be paid immediately on agreement of economic and financial policy measures set out in a memorandum of understanding (MoU), subject to the satisfactory implementation of an International Monetary Fund programme;the second instalment is also subject to the satisfactory implementation of the policy measures agreed in the MoU. FROM WHEN DOES THE DECISION APPLY? It has applied since 1 March 2022. BACKGROUND Since 2014, the EU and European financial institutions have allocated over \u20ac17 billion in grants and loans to Ukraine. This amount includes funding of \u20ac5 billion provided to Ukraine through five MFA programmes aimed at supporting the implementation of a broad reform agenda in areas such as the fight against corruption, an independent judicial system, the rule of law and improving the business climate. For further information, see: Ukraine (European Commission). MAIN DOCUMENT Decision (EU) 2022/313 of the European Parliament and of the Council of 24 February 2022 providing macro-financial assistance to Ukraine (OJ L 55, 28.2.2022, pp. 4\u201311). RELATED DOCUMENTS Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument \u2013 Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009 (OJ L 209, 14.6.2021, pp. 1\u201378). Successive amendments to Regulation (EU) 2021/947 have been incorporated in the original text. This consolidated version is of documentary value only. Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part (OJ L 161, 29.5.2014, pp. 3\u20132137). See consolidated version. last update 11.03.2022"}
{"article": "12.7.2019 EN Official Journal of the European Union L 188/1 REGULATION (EU) 2019/1154 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on a multiannual recovery plan for Mediterranean swordfish and amending Council Regulation (EC) No 1967/2006 and Regulation (EU) 2017/2107 of the European Parliament and of the Council THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The objective of the Common Fisheries Policy (\u2018CFP\u2019), as set out in Regulation (EU) No 1380/2013 of the European Parliament and of the Council (3), is to ensure exploitation of marine biological resources that provides sustainable economic, environmental and social conditions. (2) The Union is Party to the International Convention for the Conservation of Atlantic Tunas (\u2018the ICCAT Convention\u2019). (3) At the 2016 Annual Meeting of the International Commission for the Conservation of Atlantic Tunas (\u2018ICCAT\u2019) in Vilamoura, Portugal, the ICCAT Contracting Parties and Cooperating non-Contracting Parties, Entities or Fishing Entities recognised the need to address the alarming situation of swordfish (Xiphias gladius) in the Mediterranean Sea (\u2018Mediterranean swordfish\u2019), which has been overfished over the last 30 years. To that end, including avoiding the collapse of the stock, and after analysing the scientific advice of the Standing Committee on Research and Statistics (SCRS), ICCAT adopted Recommendation 16-05 establishing a multiannual recovery plan for Mediterranean swordfish (\u2018ICCAT recovery plan\u2019). In view of the fact that the current biology, structure and dynamic of the Mediterranean swordfish stock does not allow the achievement of levels of biomass capable of producing the maximum sustainable yield (MSY) in the short term, even if drastic and urgent management measures such as a total closure of the fishery were adopted, the ICCAT recovery plan is to cover the period 2017\u20132031. ICCAT Recommendation 16-05 entered into force on 12 June 2017 and is binding on the Union. (4) The Union informed the ICCAT Secretariat by letter, in December 2016, that certain measures laid down in ICCAT Recommendation 16-05 were to enter into force in the Union in January 2017, in particular in relation to the closure period established from 1 January to 31 March, and the allocation of quotas for Mediterranean swordfish fisheries. All other measures laid down in ICCAT Recommendation 16-05, together with some of the measures already implemented, should be included in the recovery plan set out in this Regulation. (5) In accordance with Article 29(2) of Regulation (EU) No 1380/2013, the positions of the Union in regional fisheries management organisations are to be based on the best available scientific advice so as to ensure that fishery resources are managed in accordance with the objectives of the CFP, in particular with the objective of progressively restoring and maintaining populations of fish stocks above biomass levels capable of producing MSY, even if in this particular case the date by which that objective has to be achieved is 2031, and with the objective of providing conditions for economically viable and competitive fishing capture and processing industry and land-based fishing related activity. At the same time account is taken of point (d) of Article 28(2) of Regulation (EU) No 1380/2013 which provides that a level playing field for Union operators vis-\u00e0-vis third-country operators is to be promoted. (6) The ICCAT recovery plan takes into account the specificities of the different types of fishing gear and fishing techniques. When implementing the ICCAT recovery plan, the Union and Member States should endeavour to promote coastal fishing activities and the research on and use of fishing gear and techniques which are selective, so as to reduce by-catches of vulnerable species, and which have a reduced environmental impact, including gear and techniques used in traditional and artisanal fisheries, thereby contributing to a fair standard of living for local economies. (7) Regulation (EU) No 1380/2013 establishes the concept of minimum conservation reference sizes. In order to ensure consistency, the ICCAT concept of minimum sizes should be implemented into Union law as minimum conservation reference sizes. (8) Pursuant to ICCAT Recommendation 16-05, Mediterranean swordfish that have been caught and are below minimum conservation reference size have to be discarded. The same applies to catches of Mediterranean swordfish exceeding the by-catch limits established by Member States in their annual fishing plans. For the purpose of the Union's compliance with its international obligations under ICCAT, Article 5a of Commission Delegated Regulation (EU) 2015/98 (4) provides for derogations from the landing obligation for Mediterranean swordfish in accordance with Article 15(2) of Regulation (EU) No 1380/2013. Delegated Regulation (EU) 2015/98 implements certain provisions of ICCAT Recommendation 16-05 which lays down the obligation to discard Mediterranean swordfish for vessels that exceed their allocated quota or their maximum level of permitted by-catches. The scope of that Delegated Regulation includes vessels engaged in recreational fishing. (9) Taking into consideration that the recovery plan set out in this Regulation will implement ICCAT Recommendation 16-05, the provisions of Regulation (EU) 2017/2107 of the European Parliament and of the Council (5) concerning Mediterranean swordfish should be deleted. (10) Fishing activities using driftnets have in the past undergone a rapid increase in terms of fishing effort and lack of sufficient selectivity. The uncontrolled expansion of those activities posed a serious risk for the target species and their use was prohibited for catching highly migratory fish, including swordfish, by Council Regulation (EC) No 1239/98 (6). (11) To ensure compliance with the CFP, Union legislation has been adopted to establish a system of control, inspection and enforcement, which includes the fight against illegal, unreported and unregulated (IUU) fishing. In particular, Council Regulation (EC) No 1224/2009 (7) establishes a Union system for control, inspection and enforcement with a global and integrated approach so as to ensure compliance with all the rules of the CFP. Commission Implementing Regulation (EU) No 404/2011 (8) lays down detailed rules for the implementation of Regulation (EC) No 1224/2009. Council Regulation (EC) No 1005/2008 (9) establishes a Community system to prevent, deter and eliminate IUU fishing. Those Regulations already include provisions that cover a number of the measures laid down in ICCAT Recommendation 16-05. It is therefore not necessary to include those provisions in this Regulation. (12) In arrangements for the chartering of fishing vessels, the relationships between the owner, the charterer and the flag State are often unclear. Some operators engaging in IUU activities evade controls by abusing those arrangements. Chartering is prohibited by Regulation (EU) 2016/1627 of the European Parliament and of the Council (10) in the context of bluefin tuna fisheries. It is appropriate, as a preventive measure to protect a stock under recovery and for sake of consistency with Union law, to adopt a similar prohibition in the recovery plan set out in this Regulation. (13) Union legislation should implement ICCAT recommendations in order to place Union and third country fishermen on an equal footing and to ensure that the rules can be accepted by all. (14) In order to swiftly implement into Union law future ICCAT recommendations amending or supplementing the ICCAT recovery plan, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the Annexes to this Regulation and certain provisions of this Regulation on deadlines for reporting information, time periods for closures, minimum conservation reference size, tolerance levels for incidental catches and by-catches, technical characteristics of fishing gear, percentage of quota uptake for the purpose of informing the Commission, as well as information to be provided on fishing vessels. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (11). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (15) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the format for the annual report on the implementation of this Regulation submitted by the Member States. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (12). (16) The delegated acts and implementing acts provided for in this Regulation should be without prejudice to the implementation of future ICCAT recommendations into Union law through the ordinary legislative procedure. (17) Annex II to Council Regulation (EC) No 1967/2006 (13) allows for a maximum of 3 500 hooks that can be set or taken on board of vessels targeting swordfish, while ICCAT Recommendation 16-05 allows for a maximum of 2 500 hooks. In order to properly implement that recommendation into Union law it is necessary to amend Regulation (EC) No 1967/2006 accordingly. (18) Section 2 of Chapter III of Regulation (EU) 2017/2107 lays down certain technical and control measures as regards Mediterranean swordfish. The measures laid down in ICCAT Recommendation 16-05, which are implemented into Union law by this Regulation, are more restrictive or more precise to allow the recovery of the stock. Section 2 of Chapter III of Regulation (EU) 2017/2107 should therefore be deleted and replaced by the relevant measures laid down in this Regulation, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down general rules for the implementation by the Union of a multiannual recovery plan for swordfish (Xiphias gladius) in the Mediterranean Sea (\u2018Mediterranean swordfish\u2019) adopted by ICCAT, starting from 2017 and continuing until 2031. Article 2 Scope This Regulation applies to: (a) Union fishing vessels, and Union vessels engaged in recreational fisheries, which: (i) catch Mediterranean swordfish; or (ii) tranship or carry on board, including outside the ICCAT Convention area, Mediterranean swordfish; (b) third country fishing vessels, and third country vessels engaged in recreational fisheries, which operate in Union waters and which catch Mediterranean swordfish; (c) third country vessels which are inspected in Member States ports and which carry on board Mediterranean swordfish or fishery products originating from Mediterranean swordfish that have not been previously landed or transhipped at ports. Article 3 Objective By way of derogation from Article 2(2) of Regulation (EU) No 1380/2013, the objective of this Regulation is to achieve a biomass of Mediterranean swordfish corresponding to MSY by 2031, with at least a 60 % probability of achieving that objective. Article 4 Relationship to other Union law This Regulation applies in addition to the following Regulations or, where those Regulations so provide, by way of derogation therefrom: (a) Regulation (EC) No 1224/2009; (b) Regulation (EU) 2017/2403 of the European Parliament and of the Council (14); (c) Regulation (EU) 2017/2107. Article 5 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018fishing vessel\u2019 means any vessel equipped for commercial exploitation of marine biological resources; (2) \u2018Union fishing vessel\u2019 means a fishing vessel flying the flag of a Member State and registered in the Union; (3) \u2018ICCAT Convention area\u2019 means all waters of the Atlantic Ocean and adjacent seas; (4) \u2018Mediterranean Sea\u2019 means maritime waters of the Mediterranean to the East of line 5\u00b036\u2032 West; (5) \u2018CPCs\u2019 means Contracting Parties to the ICCAT Convention and Cooperating non-Contracting Parties, Entities or Fishing Entities; (6) \u2018fishing authorisation\u2019 means an authorisation issued in respect of a Union fishing vessel entitling it to carry out specific fishing activities during a specified period, in a given area or for a given fishery under specific conditions; (7) \u2018fishing opportunity\u2019 means a quantified legal entitlement to fish, expressed in terms of catches or fishing effort; (8) \u2018stock\u2019 means a marine biological resource that occurs in a given management area; (9) \u2018fishery products\u2019 means aquatic organisms resulting from any fishing activity or products derived therefrom; (10) \u2018discards\u2019 means catches that are returned to the sea; (11) \u2018recreational fisheries\u2019 means non-commercial fishing activities exploiting marine biological resources for recreation, tourism or sport; (12) \u2018vessel monitoring system data\u2019 means data on the fishing vessel identification, geographical position, date, time, course and speed transmitted by satellite-tracking devices installed on board fishing vessels to the fisheries monitoring centre of the flag Member State; (13) \u2018landing\u2019 means the initial unloading of any quantity of fisheries products from on board a fishing vessel to land; (14) \u2018transhipment\u2019 means the unloading of all or any fisheries products on board a vessel to another vessel; (15) \u2018chartering\u2019 means an arrangement by which a fishing vessel flying the flag of a Member State is contracted for a defined period by an operator in either another Member State or a third country without a change of flag; (16) \u2018longlines\u2019 means a fishing gear which comprises a main line carrying numerous hooks on branch lines (snoods) of variable length and spacing depending on the target species; (17) \u2018hook\u2019 means a bent, sharpened piece of steel wire; (18) \u2018rod and line\u2019 means a fishing-line placed in a rod used by anglers and wound on a turning mechanism (reel) used to wind the line. TITLE II MANAGEMENT MEASURES, TECHNICAL CONSERVATION MEASURES AND CONTROL MEASURES CHAPTER 1 Management measures Article 6 Fishing effort 1. Each Member State shall take the necessary measures to ensure that the fishing effort of fishing vessels flying its flag is commensurate with the fishing opportunities for Mediterranean swordfish available to that Member State. 2. The carrying-over of any unused quota for Mediterranean swordfish shall be prohibited. Article 7 Allocation of fishing opportunities 1. In accordance with Article 17 of Regulation (EU) No 1380/2013, when allocating the fishing opportunities available to them, Member States shall use transparent and objective criteria, including those of an environmental, social and economic nature, and shall also endeavour to distribute national quotas fairly among the various fleet segments, giving consideration to traditional and artisanal fishing, and to provide incentives to Union fishing vessels deploying selective fishing gear or using fishing techniques with reduced environmental impact. 2. Each Member State shall make provision for by-catch of swordfish within its Mediterranean swordfish quota and shall inform the Commission thereof when transmitting its annual fishing plan in accordance with Article 9. Such provision shall ensure that all dead Mediterranean swordfish are deducted from the quota. 3. Member States shall endeavour to allocate any increase in fishing opportunities resulting from the successful implementation of this Regulation to fishing vessels to which no quota for Mediterranean swordfish has previously been allocated and that fulfil the criteria for the allocation of fishing opportunities set out in Article 17 of Regulation (EU) No 1380/2013. Article 8 Capacity limitations 1. A capacity limitation by fishing gear type for fishing vessels shall apply for the duration of the recovery plan set out in this Regulation. Member States shall limit by fishing gear type the number of fishing vessels flying their flag and authorised to catch Mediterranean swordfish to the average yearly number of vessels flying their flag that fished for, retained on board, transhipped, transported or landed Mediterranean swordfish during the period 2013-2016. 2. Notwithstanding paragraph 1, Member States may decide to use the number of vessels flying their flag that fished for, retained on board, transhipped, transported or landed Mediterranean swordfish in 2016 for the purpose of calculating the capacity limitation, if that number is lower than the average yearly number of vessels during the period 2013\u20132016. That capacity limitation shall be applied by gear type for fishing vessels. 3. Member States may apply a tolerance of 5 % to the capacity limitation referred to in paragraph 1 for the years 2018 and 2019. 4. Member States shall inform the Commission by 1 March of each year of the measures taken to limit the number of fishing vessels flying their flag and authorised to catch Mediterranean swordfish. That information shall be included in the transmission of the annual fishing plans in accordance with Article 9. Article 9 Annual fishing plans 1. Member States shall submit their annual fishing plans to the Commission by 1 March of each year. Such annual fishing plans shall be submitted in the format set out in the ICCAT Guidelines for submitting data and information, and shall include detailed information regarding the quota for Mediterranean swordfish allocated by fishing gear type, including quota allocated to recreational fisheries, where relevant, and to by-catches. 2. The Commission shall compile the annual fishing plans referred to in paragraph 1 and integrate them into a Union fishing plan. The Commission shall transmit that Union fishing plan to the ICCAT Secretariat by 15 March each year. CHAPTER 2 Technical conservation measures Section 1 Fishing seasons Article 10 Closure periods 1. Mediterranean swordfish shall not be caught, either as targeted species or as by-catch, retained on board, transhipped or landed during the closure period. The closure period shall be from 1 January to 31 March of each year. 2. In order to protect Mediterranean swordfish, a closure period shall apply to longline vessels targeting Mediterranean albacore (Thunnus alalunga) from 1 October to 30 November of each year. 3. Member States shall monitor the effectiveness of the closure periods referred to in paragraphs 1 and 2 and shall submit to the Commission, at least two months and 15 days before the ICCAT annual meeting each year, all relevant information on appropriate controls and inspections carried out the previous year to ensure compliance with this Article. The Commission shall forward that information to the ICCAT Secretariat at least two months before the ICCAT annual meeting each year. Section 2 Minimum conservation reference size, incidental catch and by-catch Article 11 Minimum conservation reference size for Mediterranean swordfish 1. By way of derogation from Article 15(1) of Regulation (EU) No 1380/2013, it shall be prohibited to catch, retain on board, tranship, land, transport, store, sell or display or offer for sale Mediterranean swordfish, including in recreational fisheries: (a) measuring less than 100 cm lower jaw to fork length (LJFL); or (b) weighing less than 11,4 kg of live weight, or 10,2 kg of gilled and gutted weight. 2. Only entire specimens of Mediterranean swordfish, without removal of any external part, or gilled and gutted specimens, may be retained on board, transhipped landed or carried in the first transport after landing. Article 12 Incidental catches of Mediterranean swordfish below the minimum conservation reference size Notwithstanding Article 11(1), fishing vessels targeting Mediterranean swordfish may retain on board, tranship, transfer, land, transport, store, sell or display or offer for sale incidental catches of Mediterranean swordfish below the minimum conservation reference size, provided such catches do not exceed 5 % by weight or number of specimens of the total Mediterranean swordfish catch of the fishing vessels concerned. Article 13 By-catches 1. By-catches of Mediterranean swordfish shall not exceed at any time following a fishing operation the by-catch limit that Member States establish in their annual fishing plans for the total catch on board by weight or number of specimens. 2. By way of derogation from Article 15(1) of Regulation (EU) No 1380/2013, fishing vessels not targeting Mediterranean swordfish shall not retain on board Mediterranean swordfish exceeding that by-catch limit. 3. By way of derogation from Article 15(1) of Regulation (EU) No 1380/2013, if the quota for Mediterranean swordfish allocated to the flag Member State is exhausted, any Mediterranean swordfish caught alive shall be released. 4. Where the quota for Mediterranean swordfish allocated to the flag Member State is exhausted, the processing and commercialisation of dead Mediterranean swordfish shall be prohibited and all catches shall be recorded. Member States shall provide information on the quantity of such dead Mediterranean swordfish on an annual basis to the Commission which shall forward it to the ICCAT Secretariat, in accordance with Article 21. Section 3 Technical characteristics of the fishing gear Article 14 Technical characteristics of the fishing gear 1. The maximum number of hooks that may be set by or carried on board fishing vessels targeting Mediterranean swordfish shall be fixed at 2 500 hooks. 2. By way of derogation from paragraph 1, a replacement set of 2 500 rigged hooks shall be allowed on board fishing vessels for trips longer than two days provided that it is duly lashed and stowed in lower decks so that it may not readily be used. 3. The hook size shall not be smaller than 7 cm in height. 4. The length of the pelagic longlines shall not exceed 30 nautical miles (55,56 km). CHAPTER 3 Control measures Section 1 Record of vessels Article 15 Fishing authorisations 1. Member States shall issue fishing authorisations to fishing vessels targeting Mediterranean swordfish and flying their flag, in accordance with the relevant provisions laid down in Regulation (EU) 2017/2403, in particular Articles 20 and 21 thereof. 2. Only Union vessels included in the ICCAT record of vessels, in accordance with the procedure laid down in Articles 16 and 17, shall be allowed to target, retain on board, tranship, land, transport or process Mediterranean swordfish, without prejudice to the provisions on by-catches laid down in Article 13. 3. Large-scale fishing vessels authorised by Member States shall be registered in the ICCAT record of vessels 20 metres in length overall or greater authorised to operate in the ICCAT Convention area. Article 16 Information on vessels authorised to catch Mediterranean swordfish and albacore tuna in the current year 1. Member States shall submit electronically each year to the Commission the following information in the format set out in the ICCAT Guidelines for submitting data and information: (a) by 1 January, the information on fishing vessels flying their flag and authorised to catch Mediterranean swordfish, as well as vessels authorised to catch Mediterranean swordfish in the context of recreational fisheries; (b) by 1 March, the information on fishing vessels flying their flag and authorised to target Mediterranean albacore tuna. The Commission shall send to the ICCAT Secretariat the information referred to in point (a) by 15 January of each year and the information referred to in point (b) by 15 March of each year. The information on the fishing vessels referred to in points (a) and (b) of the first subparagraph of this paragraph shall contain the vessel's name and Union fleet register number (CFR) as defined in Annex I to Commission Implementing Regulation (EU) 2017/218 (15). 2. In addition to the information referred to in paragraph 1, Member States shall notify the Commission of any modification of the information on fishing vessels referred to in paragraph 1 within 30 days of that modification. The Commission shall, within 45 days from the date of the modification, transmit that information to the ICCAT Secretariat. 3. In addition to any information transmitted to the ICCAT Secretariat in accordance with paragraphs 1 and 2 of this Article, the Commission shall where necessary, pursuant to Article 7(6) of Regulation (EU) 2017/2403, send updated details of the vessels referred to in paragraph 1 of this Article to the ICCAT Secretariat without delay. Article 17 Information on vessels authorised to target Mediterranean swordfish using harpoons or pelagic longlines during the preceding year 1. By 30 June of each year, Member States shall submit electronically to the Commission the following information concerning fishing vessels flying their flag that were authorised to carry out pelagic longline fisheries or harpoon fisheries targeting Mediterranean swordfish during the preceding year: (a) name of the vessel (in the absence of the name, the registry number without country initials); (b) Union fleet register number (CFR) as defined in Annex I to Implementing Regulation (EU) 2017/218; (c) ICCAT record number. 2. The information referred to in paragraph 1 shall be submitted in the format set out in the ICCAT Guidelines for submitting data and information. 3. The Commission shall send the information referred to in paragraph 1 to the ICCAT Secretariat by 31 July of each year. Section 2 Monitoring and surveillance Article 18 Vessel monitoring system 1. For control purposes, the transmission of vessel monitoring system (VMS) data from fishing vessels that are authorised to catch Mediterranean swordfish shall not be interrupted when those vessels are in port. 2. Member States shall ensure that their fisheries monitoring centres forward to the Commission and a body designated by it, in real time and using the format \u2018https data feed\u2019, the VMS messages received from the fishing vessels flying their flag. The Commission shall send those messages electronically to the ICCAT Secretariat. 3. Member States shall ensure that: (a) VMS messages from the fishing vessels flying their flag are forwarded to the Commission at least every two hours; (b) in the event of a technical malfunction of the VMS, alternative messages from the fishing vessel flying their flag received in accordance with Article 25(1) of Implementing Regulation (EU) No 404/2011 are forwarded to the Commission within 24 hours of receipt by their fisheries monitoring centres; (c) VMS messages forwarded to the Commission are numbered sequentially (with a unique identifier) in order to avoid duplication; (d) VMS messages forwarded to the Commission comply with Article 24(3) of Implementing Regulation (EU) No 404/2011. 4. Each Member State shall take the necessary measures to ensure that all VMS messages made available to its inspection vessels are treated in a confidential manner and are limited to inspection at sea operations. Article 19 Chartering of Union fishing vessels The chartering of Union fishing vessels for targeting Mediterranean swordfish shall be prohibited. Article 20 National scientific observer programmes for pelagic longline vessels 1. Each Member State with a quota for Mediterranean swordfish shall implement a national scientific observer programme for pelagic longline vessels flying that Member State's flag and targeting Mediterranean swordfish in accordance with this Article. The national observer programme shall comply with the minimum standards laid down in Annex I. 2. Each Member State concerned shall ensure that national scientific observers are deployed on at least 10 % of pelagic longline vessels over 15 metres in length overall flying that Member State's flag and targeting Mediterranean swordfish. The percentage coverage shall be measured by number of fishing days, sets, vessels or trips. 3. Each Member State concerned shall design and implement a scientific monitoring approach to collect the information on the activities of pelagic longline vessels 15 metres in length overall and below flying that Member State's flag. Each flag Member State shall present the details of that scientific monitoring approach to the Commission in its annual fishing plan referred to in Article 9 by 2020. 4. The Commission shall immediately submit the details of the scientific monitoring approach referred to in paragraph 3 to the ICCAT Standing Committee on Research and Statistics (SCRS) for evaluation. Scientific monitoring approaches shall be subject to the approval of the ICCAT Commission at the ICCAT annual meeting prior to their implementation. 5. Member States shall issue their national scientific observers with an official identification document. 6. In addition to the tasks of scientific observers laid down in Annex I, Member States shall require scientific observers to assess and report the following data on Mediterranean swordfish: (a) the level of discards of specimens below the minimum conservation reference size; (b) region specific size and age at maturity; (c) habitat use, for comparison of the availability of Mediterranean swordfish to various fisheries, including comparisons between traditional and mesopelagic longline fisheries; (d) the impact of the mesopelagic longline fisheries in terms of catch composition, catch per unit effort series and size distribution of the catches; and (e) monthly estimation of the proportion of spawners and recruits in the catches. 7. By 30 June of each year Member States shall submit to the Commission the information collected under their national scientific observer programmes of the previous year. The Commission shall forward that information to the ICCAT Secretariat by 31 July of each year. Section 3 Control of catches Article 21 Recording and reporting of catches 1. The master of each fishing vessel authorised to catch Mediterranean swordfish shall keep a fishing logbook in accordance with the requirements laid down in Annex II and shall submit the logbook information to the flag Member State. 2. Without prejudice to the reporting obligations for Member States established in Regulation (EC) No 1224/2009, Member States shall send quarterly reports to the Commission of all catches of Mediterranean swordfish made by authorised vessels flying their flag, unless such information is sent on a monthly basis. Those quarterly reports shall be sent using the aggregated catch data report format and no later than 15 days following the end of each quarter period (namely by 15 April, 15 July and 15 October of each year and by 15 January of the following year). The Commission shall send that information to the ICCAT Secretariat by 30 April, 30 July and 30 October of each year and by 30 January of the following year. 3. In addition to the information referred to in paragraph 1, Member States shall submit to the Commission, by 30 June of each year, the following information concerning Union fishing vessels that were authorised to carry out pelagic longline fisheries or harpoon fisheries targeting Mediterranean swordfish during the preceding year: (a) information related to fishing activities by target species and area, based on sampling or on the whole fleet, including: (i) fishing period(s) and total annual number of fishing days of the vessel; (ii) geographical areas, by ICCAT statistical rectangles, for the fishing activities carried out by the vessel; (iii) type of vessel; (iv) number of hooks used by the vessel; (v) number of longline units used by the vessel; (vi) overall length of all longline units for the vessel; (b) data on the catches, in the smallest time-area possible, including: (i) size and, if possible, age distributions of the catches; (ii) catches and catch composition per vessel; (iii) fishing effort (average fishing days per vessel, average number of hooks per vessel, average longline units per vessel, average overall length of longline per vessel). The Commission shall forward that information to the ICCAT Secretariat by 31 July of each year. 4. The information referred to in paragraphs 1, 2 and 3 shall be submitted in the format set out in the ICCAT Guidelines for submitting data and information. Article 22 Data on quota uptake 1. Without prejudice to Article 34 of Regulation (EC) No 1224/2009, each Member State shall inform the Commission without delay when the uptake of the quota for Mediterranean swordfish allocated to a fishing gear type is deemed to have reached 80 %. 2. When accumulated catches of Mediterranean swordfish have reached 80 % of the national quota, the flag Member States shall send data on catches to the Commission on a weekly basis. Section 4 Landings and transhipments Article 23 Designated ports 1. Catches of Mediterranean swordfish, including by-catches and Mediterranean swordfish caught in the context of recreational fisheries with no tag affixed to each specimen as referred to in Article 30, shall only be landed or transhipped in designated ports. 2. Each Member State shall designate, in accordance with Article 43(5) of Regulation (EC) 1224/2009, ports in which landings and transhipments of Mediterranean swordfish referred to in paragraph 1 shall take place. 3. By 15 February of each year, Member States shall transmit a list of designated ports to the Commission. By 1 March of each year, the Commission shall transmit that list to the ICCAT Secretariat. Article 24 Prior notification 1. Article 17 of Regulation (EC) No 1224/2009 shall apply to masters of Union fishing vessels of 12 metres in length overall or more, included in the list of vessels referred to in Article 16 of this Regulation. The prior notification referred to in Article 17 of Regulation (EC) No 1224/2009 shall be sent to the competent authority of the Member State or CPC whose ports or landing facility they intend to use, as well as to the flag Member State, if different from the port Member State. 2. Masters of Union fishing vessels under 12 metres in length overall included in the list of vessels referred to in Article 16 shall, at least four hours before the estimated time of arrival at the port, notify the competent authority of the Member State or the CPC whose ports or landing facility they wish to use, as well as the flag Member State, if different from the port Member State, the following information: (a) estimated time of arrival; (b) estimated quantity of Mediterranean swordfish retained on board; and (c) the information on the geographical area where the catch was taken. 3. If the fishing grounds are less than four hours from the port, the estimated quantities of Mediterranean swordfish retained on board may be modified at any time prior to arrival. 4. The authorities of the port Member States shall maintain a record of all prior notifications for the current year. Article 25 Transhipments 1. Transhipment at sea by Union vessels carrying on board Mediterranean swordfish, or by third country vessels in Union waters, shall be prohibited in all circumstances. 2. Without prejudice to Article 51, Article 52(2) and (3) and Articles 54 and 57 of Regulation (EU) 2017/2107, vessels shall only tranship Mediterranean swordfish in designated ports. Section 5 Inspections Article 26 Annual inspection plans 1. By 31 January each year, Member States shall transmit their annual inspection plans to the Commission. Those annual inspection plans shall be set up in accordance with: (a) the objectives, priorities and procedures as well as benchmarks for inspection activities set out in Commission Implementing Decision (EU) 2018/1986 (16); and (b) the national control action programme for Mediterranean swordfish established under Article 46 of Regulation (EC) No 1224/2009. 2. The Commission shall compile the national inspection plans and integrate them into the Union inspection plan. The Union inspection plan shall be transmitted by the Commission to the ICCAT Secretariat, for endorsement by ICCAT, together with the annual fishing plans referred to in Article 9. Article 27 ICCAT Scheme of Joint International Inspection 1. Joint international inspection activities shall be carried out in accordance with the ICCAT Scheme for Joint International Inspection (\u2018the ICCAT Scheme\u2019) set out in Annex III. 2. Member States whose fishing vessels are authorised to catch Mediterranean swordfish shall assign inspectors and carry out inspections at sea under the ICCAT Scheme. The Commission or a body designated by it may assign Union inspectors to the ICCAT Scheme. 3. When, at any time, more than 50 fishing vessels flying the flag of a Member State are engaged in Mediterranean swordfish fisheries in the ICCAT Convention area, that Member State shall deploy an inspection vessel for the purpose of inspection and control at sea in the Mediterranean Sea throughout the period that those vessels are there. That obligation shall also be deemed to have been complied with where Member States cooperate to deploy an inspection vessel or where a Union inspection vessel is deployed in the Mediterranean Sea. 4. The Commission or a body designated by it shall coordinate the surveillance and inspection activities for the Union. The Commission may draw up, in coordination with the Member State concerned, joint inspection programmes to enable the Union to fulfil its obligation under the ICCAT Scheme. Member States whose fishing vessels are engaged in Mediterranean swordfish fisheries shall adopt the necessary measures to facilitate the implementation of those joint inspection programmes, in particular as regards the human and material resources required and the periods when and geographical areas where those resources are to be deployed. 5. Member States shall inform the Commission, by 1 December of each year, of the names of the inspectors and the inspection vessels they intend to assign to the ICCAT Scheme during the following year. Using that information, the Commission shall draw up, in collaboration with the Member States, an annual plan for the Union participation in the ICCAT Scheme, which it shall send to the ICCAT Secretariat by 1 January of each year. Article 28 Inspections in case of infringements Where a vessel flying the flag of a Member State has committed an infringement of the provisions of this Regulation, that Member State shall ensure that a physical inspection of that vessel takes place under its authority in its ports or, where the vessel is not in one of its ports, by a person designated by that Member State. CHAPTER 4 Recreational fisheries Article 29 Management measures 1. Each Member State allowing recreational fishing for Mediterranean swordfish shall make provision for a recreational fisheries quota within its national quota and shall inform the Commission thereof when transmitting its annual fishing plan in accordance with Article 9. Such provision shall ensure that all dead Mediterranean swordfish are deducted from the quota. 2. The Member States referred to in paragraph 1 of this Article shall, for the vessels flying their flag which are engaged in recreational fisheries for Mediterranean swordfish, ensure that the information on authorised vessels referred to in Article 30(2) includes those vessels. Vessels not included with that information shall not be authorised to fish for Mediterranean swordfish. 3. The selling and any other form of marketing of Mediterranean swordfish caught in recreational fisheries shall be prohibited. 4. Notwithstanding Article 15(1) of Regulation (EU) No 1380/2013, it shall be prohibited to catch, retain on board, tranship or land more than one Mediterranean swordfish per vessel per day for recreational fisheries. The Member States concerned shall take the necessary measures to ensure, to the greatest extent possible, and to facilitate the release of Mediterranean swordfish caught alive in the framework of recreational fishing, and may take more restrictive measures which improve the protection of Mediterranean swordfish. Article 30 Control measures 1. Only \u2018rod and line\u2019 vessels shall be authorised to catch Mediterranean swordfish in recreational fisheries. 2. The information on authorised recreational vessels sent to the ICCAT Secretariat in accordance with point (a) of Article 16(1) shall include the following: (a) name of the vessel (in the absence of the name, the registry number without country initials); (b) previous name of the vessel, where applicable; (c) vessel's length overall; (d) name and address of owner(s) and operator(s) of the vessel. 3. Catch data, including length (LJFL) and live weight of each Mediterranean swordfish caught, retained on board and landed in the context of recreational fisheries shall be recorded and reported in accordance with Article 21. 4. Mediterranean swordfish may only be landed whole or gilled and gutted, and either in a designated port in accordance with Article 23, or with a tag affixed to each specimen. Each tag shall have a unique country specific number and be tamper proof. 5. Member States shall establish a tagging programme for the purposes of this Regulation and include the specifications of such programme in the annual fishing plans referred in Article 9. 6. Each Member State shall only authorise the use of tags as long as the accumulated catch amounts are within the quota allocated to it. 7. Each year Member States shall send to the Commission a report on the implementation of the tagging programme, at least two months and 15 days before the ICCAT annual meeting. The Commission shall compile the information from Member States and send it to the ICCAT Secretariat at least two months before the ICCAT annual meeting. TITLE III FINAL PROVISIONS Article 31 Annual report 1. By 15 September of each year, Member States shall submit to the Commission a report, for the preceding calendar year, on their implementation of this Regulation, and any additional information as appropriate. 2. The annual report shall include information on the steps taken to mitigate by-catch and reduce discards of Mediterranean swordfish below the minimum conservation reference size, and on any relevant research in that field. 3. The Commission shall compile the information received pursuant to paragraphs 1 and 2, and shall forward it to the ICCAT Secretariat by 15 October of each year. 4. The Commission may adopt implementing acts as regards detailed requirements for the format of the annual report referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 36(2). Article 32 Review The Commission shall report to the European Parliament and to the Council on the functioning of the recovery plan set out in this Regulation by 31 December 2025. Article 33 Financing For the purposes of Regulation (EU) No 508/2014 of the European Parliament and of the Council (17), the recovery plan set out in this Regulation shall be deemed to be a multiannual plan within the meaning of Article 9 of Regulation (EU) No 1380/2013. Article 34 Procedure for amendments 1. Where necessary in order to implement into Union law ICCAT recommendations amending or supplementing the ICCAT recovery plan which become binding on the Union, and insofar as amendments to Union law do not go beyond ICCAT recommendations, the Commission is empowered to adopt delegated acts in accordance with Article 35 for the purpose of amending: (a) deadlines for reporting information as laid down in Article 9(1) and (2), Article 10(3), Article 16(1) and (3), Article 17(1) and (3), Article 21(2) and (3), Article 22(2), Article 23(3), Article 26(1), Article 27(5) and Article 31(1) and (3); (b) closure periods as provided in Article 10(1) and (2); (c) the minimum conservation reference size set out in Article 11(1); (d) the tolerance levels referred to in Articles 12 and 13; (e) the technical characteristics of the fishing gear laid down in Article 14(1) to (4); (f) the percentage of quota uptake laid down in Article 22(1) and (2); (g) the information on vessels referred to in Article 16(1) and (2), Article 17(1), Article 21(1), (2), (3) and (4) and Article 30(2); and (h) Annexes I, II and III. 2. Any amendments adopted in accordance with paragraph 1 shall be strictly limited to the implementation of amendments or supplements to the corresponding ICCAT recommendations into Union law. Article 35 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 34 shall be conferred on the Commission for a period of five years from 15 July 2019. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 34 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 34 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 36 Committee procedure 1. The Commission shall be assisted by the Committee for Fisheries and Aquaculture established by Article 47 of Regulation (EU) No 1380/2013. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 37 Amendments to Regulation (EU) 2017/2107 In Regulation (EU) 2017/2107, Articles 20 to 26 are deleted. Article 38 Amendments to Regulation (EC) No 1967/2006 In Annex II to Regulation (EC) No 1967/2006, point 6(2) is replaced by the following: \u20182. 2 500 hooks for vessels targeting swordfish (Xiphias gladius) where this species account for at least 70 % of the catch in live weight after sorting;\u2019. Article 39 This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 440, 6.12.2018, p. 174. (2) Position of the European Parliament of 4 April 2019 (not yet published in the Official Journal) and decision of the Council of 6 June 2019. (3) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (4) Commission Delegated Regulation (EU) 2015/98 of 18 November 2014 on the implementation of the Union's international obligations, as referred to in Article 15(2) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council, under the International Convention for the Conservation of Atlantic Tunas and the Convention on Future Multilateral Cooperation in the Northwest Atlantic Fisheries (OJ L 16, 23.1.2015, p. 23). (5) Regulation (EU) 2017/2107 of the European Parliament and of the Council of 15 November 2017 laying down management, conservation and control measures applicable in the Convention area of the International Commission for the Conservation of Atlantic Tunas (ICCAT), and amending Council Regulations (EC) No 1936/2001, (EC) No 1984/2003 and (EC) No 520/2007 (OJ L 315, 30.11.2017, p. 1). (6) Council Regulation (EC) No 1239/98 of 8 June 1998 amending Regulation (EC) No 894/97 laying down certain technical measures for the conservation of fishery resources (OJ L 171, 17.6.1998, p. 1). (7) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (8) Commission Implementing Regulation (EU) No 404/2011 of 8 April 2011 laying down detailed rules for the implementation of Council Regulation (EC) No 1224/2009 establishing a Community control system, for ensuring compliance with the rules of the Common Fisheries Policy (OJ L 112, 30.4.2011, p. 1). (9) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (10) Regulation (EU) 2016/1627 of the European Parliament and of the Council of 14 September 2016 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, and repealing Council Regulation (EC) No 302/2009 (OJ L 252, 16.9.2016, p. 1). (11) OJ L 123, 12.5.2016, p. 1. (12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (13) Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, p. 11). (14) Regulation (EU) 2017/2403 of the European Parliament and of the Council of 12 December 2017 on the sustainable management of external fishing fleets, and repealing Council Regulation (EC) No 1006/2008 (OJ L 347, 28.12.2017, p. 81). (15) Commission Implementing Regulation (EU) 2017/218 of 6 February 2017 on the Union fishing fleet register (OJ L 34, 9.2.2017, p. 9). (16) Commission Implementing Decision (EU) 2018/1986 of 13 December 2018 establishing specific control and inspection programmes for certain fisheries and repealing Implementing Decisions 2012/807/EU, 2013/328/EU, 2013/305/EU and 2014/156/EU (OJ L 317, 14.12.2018, p. 29). (17) Regulation (EU) No 508/2014 of the European Parliament and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council (OJ L 149, 20.5.2014, p. 1). ANNEX I ICCAT MINIMUM STANDARDS FOR FISHING VESSELS SCIENTIFIC OBSERVER PROGRAMMES General Provisions 1. These are the minimum standards for fishing vessels scientific observer programmes laid down in ICCAT Recommendation 16-14. Qualifications of Observers 2. Without prejudice to any training or technical qualifications recommended by the SCRS, CPCs shall ensure that their observers have the following minimum qualifications to accomplish their tasks: (a) sufficient knowledge and experience to identify ICCAT species and fishing gear configurations; (b) the ability to observe and record accurately the information to be collected under the programme; (c) the capability of performing the tasks set forth in paragraph 7 below; (d) the ability to collect biological samples; and (e) minimum and adequate training in safety and sea survival. 3. In addition, in order to ensure the integrity of their national observer programme, CPCs shall ensure the observers: (a) are not crew members of the fishing vessel being observed; (b) are not employees of the owner or beneficial owner of the fishing vessel being observed; and (c) do not have current financial or beneficial interests in the fisheries being observed. Observer Coverage 4. Each CPC shall ensure the following with respect to its domestic observer programmes: (a) a minimum of 5 % observer coverage of fishing effort in each of the pelagic longline and as defined in the ICCAT glossary, baitboat, traps, gillnet and trawl fisheries. The percentage coverage will be measured: (i) for pelagic longline fisheries, by number of fishing days, sets, or trips; (ii) for baitboat and trap fisheries, in fishing days; (iii) for gillnet fisheries, in fishing hours or days; and (iv) for trawl fisheries, in fishing hauls or days; (b) Notwithstanding point (a), for vessels less than 15 metres in length overall, where an extraordinary safety concern may exist that precludes deployment of an onboard observer, a CPC may employ an alternative scientific monitoring approach that will collect data equivalent to that specified in ICCAT Recommendation 16-14 in a manner that ensures comparable coverage. In any such cases, the CPC wishing to avail itself of an alternative approach must present the details of the approach to the SCRS for evaluation. The SCRS will advise ICCAT on the suitability of the alternative approach for carrying out the data collection obligations set out in ICCAT Recommendation 16-14. Alternative approaches implemented pursuant to this provision shall be subject to the approval of ICCAT at the annual meeting prior to implementation; (c) representative temporal and spatial coverage of the operation of the fleet to ensure the collection of adequate and appropriate data as required under ICCAT Recommendation 16-14 and any additional domestic CPC observer programme requirements, taking into account characteristics of the fleets and fisheries; (d) data collection on pertinent aspects of the fishing operation, including catch, as detailed in paragraph 7. 5. CPCs may conclude bilateral arrangements whereby one CPC places its domestic observers on vessels flying the flag of another CPC, as long as all provisions of ICCAT Recommendation 16-14 are complied with. 6. CPCs shall endeavour to ensure that observers alternate vessels between their assignments. Tasks of the Observer 7. CPCs shall require, inter alia, observers to: (a) Record and report upon the fishing activity of the observed vessel, which shall include at least the following: (i) data collection, that includes quantifying total target catch, discards and by-catch (including sharks, sea turtles, marine mammals, and seabirds), estimating or measuring size composition as practicable, disposition status (i.e., retained, discarded dead, released alive), the collection of biological samples for life history studies (e.g., gonads, otoliths, spines, scales); (ii) collect and report on all tags found; (iii) fishing operation information, including: \u2014 location of catch by latitude and longitude, \u2014 fishing effort information (e.g., number of sets, number of hooks, etc.), \u2014 date of each fishing operation, including, as appropriate, the start and stop times of the fishing activity, \u2014 use of fish aggregating objects, including fish aggregating devices (FADs), and \u2014 general condition of released animals related to survival rates (i.e. dead/alive, wounded, etc.); (b) observe and record the use of by-catch mitigation measures and other relevant information; (c) to the extent possible, observe and report environmental conditions (e.g., sea state, climate and hydrologic parameters, etc.); (d) observe and report on FADs, in accordance with the ICCAT Observer programme adopted under the multiannual conservation and management programme for tropical tuna; and (e) perform any other scientific tasks as recommended by SCRS and agreed by ICCAT. Obligations of the observer 8. CPCs shall ensure that the observer: (a) does not interfere with the electronic equipment of the vessel; (b) is familiar with the emergency procedures aboard the vessel, including the location of life rafts, fire extinguishers and first aid kits; (c) communicates as needed with the master on relevant observer issues and tasks; (d) does not hinder or interfere with the fishing activities and the normal operations of the vessel; (e) participates in a debriefing session(s) with appropriate representatives of the scientific institute or the domestic authority responsible for implementing the observer programme. Obligations of the master 9. CPCs shall ensure that the master of the vessel to which the observer is assigned: (a) permits appropriate access to the vessel and its operations; (b) allows the observer to carry out his/her responsibilities in an effective way, including by: (i) providing appropriate access to the vessel's gear, documentation (including electronic and paper logbooks), and catch; (ii) communicating at any time with appropriate representatives of the scientific institute or domestic authority; (iii) ensuring appropriate access to electronics and other equipment pertinent to fishing, including but not limited to: \u2014 satellite navigation equipment, \u2014 electronic means of communication; (iv) ensuring that no one on board the observed vessel tampers with or destroys observer equipment or documentation; obstructs, interferes with, or otherwise acts in a manner that could unnecessarily prevent the observer from performing his or her duties; intimidates, harasses, or harms the observer in any way; or bribes or attempts to bribe the observer; (c) provides accommodation to observers, including lodging, food and adequate sanitary and medical facilities, equal to those of officers; (d) provides the observer adequate space on the bridge or pilot house to perform his/her tasks, as well as space on deck adequate for carrying out observer tasks. Duties of the CPCs 10. Each CPC shall: (a) require its vessels, when fishing for ICCAT species, to carry a scientific observer in accordance with the provisions of ICCAT Recommendation 16-14; (b) oversee the safety of its observers; (c) encourage, where feasible and appropriate, their scientific institute or domestic authority to enter into agreements with the scientific institutes or domestic authorities of other CPCs for the exchange of observer reports and observer data between them; (d) provide in its annual report for use by ICCAT and the SCRS, specific information on the implementation of ICCAT Recommendation 16-14, which shall include: (i) details on the structure and design of their scientific observer programmes, including, inter alia: \u2014 the target level of observer coverage by fishery and gear type as well as how measured, \u2014 data required to be collected, \u2014 data collection and handling protocols in place, \u2014 information on how vessels are selected for coverage to achieve the CPC's target level of observer coverage, \u2014 observer training requirements, and \u2014 observer qualification requirements; (ii) the number of vessels monitored, the coverage level achieved by fishery and gear type; and (iii) details on how those coverage levels were calculated; (e) following the initial submission of the information required under paragraph 10(d)(i), report changes to the structure or design of its observer programmes in its annual reports only when such changes occur. CPCs shall continue to report the information required pursuant to paragraph 10(d)(ii) to ICCAT annually; (f) each year, using the designated electronic formats that are developed by the SCRS, report to the SCRS information collected through domestic observer programmes for use by ICCAT, in particular for stock assessment and other scientific purposes, in line with procedures in place for other data reporting requirements and consistent with domestic confidentiality requirements; (g) ensure implementation of robust data collection protocols by its observers, when carrying out their tasks referred to in paragraph 7, including, as necessary and appropriate, the use of photography. Duties of the Executive Secretary 11. The Executive Secretary facilitates access by SCRS and ICCAT to relevant data and information submitted pursuant to ICCAT Recommendation 16-14. Duties of the SCRS 12. The duties of the SCRS are to: (a) develop, as needed and appropriate, an observer working manual for voluntary use by CPCs in their domestic observer programmes, that includes model data collection forms and standardised data collection procedures, taking into account observer manuals and related materials that may already exist through other sources, including CPCs, regional and sub-regional bodies, and other organisations; (b) develop fisheries specific guidelines for electronic monitoring systems; (c) provide ICCAT with a summary of the scientific data and information collected and reported pursuant to ICCAT Recommendation 16-14 and any relevant associated findings; (d) make recommendations, as necessary and appropriate, on how to improve the effectiveness of scientific observer programmes in order to meet the data needs of ICCAT, including possible revisions to ICCAT Recommendation 16-14 or with respect to implementation of these minimum standards and protocols by CPCs. Electronic Monitoring Systems 13. Where they have been determined by SCRS to be effective in a particular fishery, electronic monitoring systems may be installed on board fishing vessels to complement or, pending SCRS advice and an ICCAT decision, to replace the human observer on board. 14. CPCs should consider any applicable guidelines that are endorsed by SCRS on the use of electronic monitoring systems. 15. CPCs are encouraged to report to the SCRS their experiences in the use of electronic monitoring systems in their ICCAT fisheries to complement human observer programmes. CPCs who have not yet implemented such systems are encouraged to explore their use and report their findings to the SCRS. ANNEX II REQUIREMENTS FOR FISHING LOGBOOKS Minimum specifications for fishing logbooks: 1. The logbook shall be numbered by sheet. 2. The logbook shall be completed every day (midnight) or before port arrival. 3. The logbook shall be completed in case of at-sea inspections. 4. One copy of the sheets shall remain attached to the logbook. 5. Logbooks shall be kept on board to cover a period of one year of operation. Minimum standard information for fishing logbooks: 1. Master's name and address. 2. Dates and ports of departure, dates and ports of arrival. 3. Vessel's name, register number, ICCAT number, international radio call sign and IMO number (if available). 4. Fishing gear: (a) type FAO code; (b) dimension (e.g. length, mesh size, number of hooks). 5. Operations at sea with one line (minimum) per day of trip, providing: (a) activity (e.g. fishing, steaming); (b) position: exact daily positions (in degree and minutes), recorded for each fishing operation or at midday when no fishing has been conducted during that day; (c) record of catches, including: (i) FAO code; (ii) round (RWT) weight in kg per day; (iii) number of specimens per day. 6. Master's signature. 7. Means of weight measure: estimation, weighing on board. 8. The logbook shall be kept in equivalent live weight of fish and shall mention the conversion factors used in the evaluation. Minimum information for fishing logbooks in case of landing or transhipment: 1. Dates and port of landing or transhipment. 2. Products: (a) species and presentation by FAO code; (b) number of fish or boxes and quantity in kg. 3. Signature of the master or vessel agent. 4. In case of transhipment: receiving vessel name, its flag and ICCAT number. ANNEX III ICCAT SCHEME OF JOINT INTERNATIONAL INSPECTION Pursuant to paragraph 3 of Article IX of the ICCAT Convention, ICCAT recommends the establishment of the following arrangements for international control outside the waters under national jurisdiction for the purpose of ensuring the application of the ICCAT Convention and the measures in force thereunder: I. Serious violations 1. For the purposes of these procedures, a serious violation means the following violations of the provisions of the ICCAT conservation and management measures adopted by ICCAT: (a) fishing without a license, permit or authorisation issued by the flag CPC; (b) failure to maintain sufficient records of catch and catch-related data in accordance with the ICCAT's reporting requirements or significant misreporting of such catch or catch-related data; (c) fishing in a closed area; (d) fishing during a closed season; (e) intentional taking or retention of species in contravention of any applicable conservation and management measure adopted by ICCAT; (f) significant violation of catch limits or quotas in force pursuant to the ICCAT rules; (g) using prohibited fishing gear; (h) falsifying or intentionally concealing the markings, identity or registration of a fishing vessel; (i) concealing, tampering with or disposing of evidence relating to investigation of a violation; (j) multiple violations which taken together constitute a serious disregard of measures in force pursuant to ICCAT; (k) assault, resist, intimidate, sexually harass, interfere with, or unduly obstruct or delay an authorised inspector or observer; (l) intentionally tampering with or disabling the VMS; (m) such other violations as may be determined by ICCAT, once these are included and circulated in a revised version of these procedures; (n) interference with the satellite monitoring system or operation of a vessel without a VMS; (o) transhipment at sea. 2. In the case of any boarding and inspection of a fishing vessel during which the authorised inspectors observe an activity or condition that would constitute a serious violation, as defined in paragraph 1, the authorities of the flag State of the inspection vessel shall immediately notify the flag State of the fishing vessel, directly as well as through the ICCAT Secretariat. In such situations, the inspector should, also inform any inspection vessel of the flag State of the fishing vessel known to be in the vicinity. 3. ICCAT inspectors shall register the inspections undertaken and the infringements detected (if any) in the fishing vessel logbook. 4. The flag State CPC shall ensure that, following the inspection referred to in paragraph 2, the fishing vessel concerned ceases all fishing activities. The flag State CPC shall require the fishing vessel to proceed within 72 hours to a port designated by it, where an investigation shall be initiated. 5. In the case where an inspection has detected an activity or condition that would constitute a serious violation, the vessel should be reviewed under the procedures described in ICCAT Recommendation 11-18 Further Amending Recommendation 09-10 Establishing a List of Vessels Presumed to Have Carried Out Illegal, Unreported and Unregulated Fishing Activities in the ICCAT Convention Area, taking into account any response actions and other follow up. II. Conduct of inspections 6. Inspections shall be carried out by inspectors designated by the Contracting Governments. The names of the authorised government agencies and individual inspectors designated for that purpose by their respective governments shall be notified to the ICCAT Commission. 7. Inspection vessels carrying out international boarding and inspection duties in accordance with this Annex shall fly a special flag or pennant approved by the ICCAT Commission and issued by the ICCAT Secretariat. The names of the vessels so used shall be notified to the ICCAT Secretariat as soon as practical in advance of the commencement of inspection activities. The ICCAT Secretariat shall make information regarding designated inspection vessels available to all CPCs, including by posting on its password-protected website. 8. Inspectors shall carry appropriate identity documentation issued by the authorities of the flag State, which shall be in the form shown in paragraph 21. 9. Subject to the arrangements agreed under paragraph 16, a fishing vessel flagged to a Contracting Party and fishing for tuna or tuna-like fishes in the ICCAT Convention area outside waters under national jurisdiction shall stop when given the appropriate signal in the International Code of Signals by an inspection vessel flying the ICCAT pennant described in paragraph 7 and carrying an inspector unless the fishing vessel is actually carrying out fishing operations, in which case it shall stop immediately once it has finished such operations. The master of the fishing vessel shall permit the inspection party, as specified in paragraph 10, to board it and must provide a boarding ladder. The master shall enable the inspection party to make such examination of equipment, catch or gear and any relevant documents as an inspector deems necessary to verify compliance with ICCAT recommendations in force in relation to the flag State of the fishing vessel being inspected. Further, inspectors may ask for any explanations that they deem necessary. 10. The size of the inspection party shall be determined by the commanding officer of the inspection vessel taking into account relevant circumstances. The inspection party should be as small as possible to accomplish the duties set out in this Annex safely and securely. 11. Upon boarding the fishing vessel, inspectors shall produce the identity documentation described in paragraph 8. Inspectors shall observe generally accepted international regulations, procedures and practices relating to the safety of the fishing vessel being inspected and its crew, and shall minimise interference with fishing activities or stowage of product and, to the extent practicable, avoid action which would adversely affect the quality of the catch on board. Inspectors shall limit their enquiries to the ascertainment of the observance of ICCAT recommendations in force in relation to the flag State of the fishing vessel concerned. In making the inspection, inspectors may ask the master of the fishing vessel for any assistance they may require. Inspectors shall draw up a report of the inspection in a form approved by the ICCAT Commission. Inspectors shall sign the report in the presence of the master of the fishing vessel who shall be entitled to add or have added to the report any observations which he or she may think suitable and must sign such observations. 12. Copies of the report shall be given to the master of the fishing vessel and to the government of the inspection party, which shall transmit copies to the appropriate authorities of the flag State of the inspected fishing vessel and to the ICCAT Commission. Where any infringement of ICCAT recommendations is discovered, the inspector should, where possible, also inform any inspection vessel of the flag State of the fishing vessel known to be in the vicinity. 13. Resistance to inspectors or failure to comply with their directions shall be treated by the flag State of the inspected fishing vessel in a manner similar to such conduct committed with respect to a national inspector. 14. Inspectors shall carry out their duties under these arrangements in accordance with the rules set out in this Regulation, but they shall remain under the operational control of their national authorities and shall be responsible to them. 15. Contracting Governments shall consider and act on inspection reports, sighting information sheets as per ICCAT Recommendation 94-09 and statements resulting from documentary inspections of foreign inspectors under these arrangements on a similar basis in accordance with their national legislation to the reports of national inspectors. The provisions of this paragraph shall not impose any obligation on a Contracting Government to give the report of a foreign inspector a higher evidential value than it would possess in the inspector's own country. Contracting Governments shall collaborate in order to facilitate judicial or other proceedings arising from a report of an inspector under these arrangements. 16. (a) Contracting Governments shall inform the ICCAT Commission by 1 January each year of their provisional plans for conducting inspection activities under ICCAT Recommendation 16-05 in that calendar year and the ICCAT Commission may make suggestions to Contracting Governments for the coordination of national operations in this field including the number of inspectors and inspection vessels carrying inspectors; (b) the arrangements set out in ICCAT Recommendation 16-05 and the plans for participation shall apply between Contracting Governments unless otherwise agreed between them, and such agreement shall be notified to the ICCAT Commission. Provided, however, that implementation of the scheme shall be suspended between any two Contracting Governments if either of them has notified the ICCAT Commission to that effect, pending completion of such an agreement. 17. (a) The fishing gear shall be inspected in accordance with the regulations in force for the subarea for which the inspection takes place. Inspectors will state the subarea for which the inspection took place, and a description of any violations found, in the inspection report; (b) inspectors shall have the authority to inspect all fishing gear in use or on board. 18. Inspectors shall affix an identification mark approved by the ICCAT Commission to any fishing gear inspected which appears to be in contravention of ICCAT recommendations in force in relation to the flag State of the fishing vessel concerned and shall record that fact in his/her report. 19. Inspectors may photograph the gears, equipment, documentation and any other element he/she considers necessary in such a way as to reveal those features which in their opinion are not in conformity with the regulation in force, in which case the subjects photographed should be listed in the report and copies of the photographs should be attached to the copy of the report to the flag State. 20. Inspectors shall, as necessary, inspect all catch on board to determine compliance with ICCAT recommendations. 21. The model Identity Card for inspectors is as follows: dimensions: width 10,4 cm, height 7 cm.", "summary": "Multiannual recovery plan for Mediterranean swordfish Multiannual recovery plan for Mediterranean swordfish SUMMARY OF: Regulation (EU) 2019/1154 on a multiannual recovery plan for Mediterranean swordfish WHAT IS THE AIM OF THE REGULATION? It lays down rules for the European Union (EU) implementation of the International Commission for the Conservation of Atlantic Tunas\u2019 (ICCAT) multiannual recovery plan for swordfish in the Mediterranean Sea. The aim is to achieve a maximum sustainable yield* of Mediterranean swordfish by 2031, with at least a 60% probability of achieving that target. KEY POINTS The regulation applies to: EU vessels carrying out commercial or recreational fishing, which catch, transship* or carry on board Mediterranean swordfish, whether inside or outside the ICCAT Convention area; non-EU vessels carrying out commercial or recreational Mediterranean swordfish fishing in EU watersinspected in EU Member State ports with Mediterranean swordfish or fishery products on board. The recovery plan started in 2017 and continues until 2031. Management measures Member States must: ensure that the fishing effort* of their vessels respects the fishing opportunities* they are given; use transparent and objective criteria \u2014 notably environmental, social and economic criteria \u2014 when sharing out national quotas among their fleet and consider the needs of traditional and artisanal fishing; provide for a maximum by-catch* of swordfish within their quota; limit the number of vessels allowed to catch Mediterranean swordfish to the annual average number of vessels fishing between 2013 and 2016; operate national scientific observer programmes for pelagic longline vessels and ensure that observers are deployed on at least 10% of vessels over 15 metres in length (Annex I sets out the terms and duties of the programmes). Technical conservation Fishing is not allowed between 1 January and 31 March each year. An additional closure period applies to longline vessels targeting Mediterranean albacore between 1 October and 30 November. Mediterranean swordfish less than 100 cm in length and weighing under 11.4 kg may not be caught, landed, stored, sold or displayed. Vessels may not use more than 2,500 hooks and longlines must not exceed 30 nautical miles (55.56 km). Controls Fishing vessels: need Member State authorisation and must be included in the ICCAT register; must transmit uninterrupted data from their vessel monitoring system \u2014 even when in port \u2014 to national monitoring centres, which forward this information at least every 2 hours to the European Commission, which in turn sends it to the ICCAT secretariat; may not be chartered to catch Mediterranean swordfish; must keep a fishing logbook (Annex II sets out the data to be recorded) and provide this data to their national authorities; may only land or transship catches of Mediterranean swordfish and by-catches in designated ports (transshipment at sea is prohibited) and must give the ports prior notification of their arrival. Member States must inform the Commission when 80% of a swordfish quota has been reached and thereafter report on catches on a weekly basis. Inspections Member States must: establish and implement annual inspection plans, which the Commission will integrate into an EU inspection plan; deploy an inspection and control vessel whenever more than 50 of their vessels are catching swordfish; physically inspect, either in port or at sea, vessels that break the rules. Joint international inspections are carried out according to the ICATT Scheme for Joint International Inspection (Annex III details how these operate). The Commission may assign EU inspectors to accompany national inspectors. Recreational fisheries Member States must: establish a recreational fisheries quota within their national quota; prohibit swordfish caught during recreational fishing from being sold or marketed; allow only rod and line vessels to participate in recreational fishing; require details of the vessels involved, their owners and catch data, including the weight of each swordfish caught. Member States must also submit a wide range of information \u2014 annual reports, fishing plans, details of authorised vessels, inspections made and data collected by scientific observers \u2014 to the Commission, which will forward much of it to the ICCAT secretariat. The Commission: may adopt implementing and delegated acts; reports to the European Parliament and the Council of the European Union on the recovery plan\u2019s performance by 31 December 2025. The regulation makes small amendments to: Regulation (EU) 2017/2107 on the management, conservation and control measures applicable in the ICCAT convention area by deleting articles 20 to 26; Regulation (EC) No 1967/2006 on the sustainable exploitation of fish stocks in the Mediterranean Sea (see summary) by reducing the number of hooks per vessels from 3,500 to 2,500. FROM WHEN DOES THE REGULATION APPLY? It has applied since 15 July 2019. BACKGROUND The International Convention for the Conservation of Atlantic Tunas (see summary) provides for regional cooperation on the conservation and management of tunas and tuna-like species in the Atlantic Ocean and adjoining seas \u2014 and establishes ICCAT. The EU has been a contracting party to the ICCAT Convention since 14 November 1997. The EU accounts for some 70% of the total catches of Mediterranean swordfish. Greece, Spain and Italy catch the most, with a further 10% shared between France, Croatia, Cyprus and Malta. Other countries, notably Algeria, Morocco, Tunisia and Turkey, also exploit the stock. The regulation essentially implements the multiannual recovery plan adopted by ICCAT in 2016. However, it introduces some stronger control and monitoring requirements. KEY TERMS Maximum sustainable yield: the maximum catch that can be taken from a stock without damaging its long-term health. Transship: transferring a catch from a vessel to another vessel. Fishing effort: a measure of the amount of fishing through inputs such as days at sea, length of nets and number of hooks. Fishing opportunities: a quantified legal entitlement to fish expressed by catches or fishing effort. By-catch: unwanted fish and marine species caught unintentionally. MAIN DOCUMENT Regulation (EU) 2019/1154 of the European Parliament and of the Council of 20 June 2019 on a multiannual recovery plan for Mediterranean swordfish and amending Council Regulation (EC) No 1967/2006 and Regulation (EU) 2017/2107 of the European Parliament and of the Council (OJ L 188, 12.7.2019, pp. 1\u201324) RELATED DOCUMENTS Regulation (EU) 2017/2107 of the European Parliament and of the Council of 15 November 2017 laying down management, conservation and control measures applicable in the Convention area of the International Commission for the Conservation of Atlantic Tunas (ICCAT), and amending Council Regulations (EC) No 1936/2001, (EC) No 1984/2003 and (EC) No 520/2007 (OJ L 315, 30.11.2017, pp. 1\u201339) Successive amendments to Regulation (EU) 2017/2107 have been incorporated into the original text. This consolidated version is of documentary value only. Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, pp. 11-85). Text republished in corrigendum (OJ L 36, 8.2.2007, pp. 6\u201330) See consolidated version. last update 23.09.2021"}
{"article": "20.12.2013 EN Official Journal of the European Union L 347/884 COUNCIL REGULATION (EU, EURATOM) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 312 thereof, Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a thereof, Having regard to the proposal from the European Commission, Having regard to the consent of the European Parliament, After transmission of the draft legislative act to national parliaments, Acting in accordance with a special legislative procedure, Whereas: (1) The annual ceilings on commitments appropriations by category of expenditure and the annual ceilings on payment appropriations established by this Regulation must respect the ceilings set for commitments and own resources in Council Decision 2007/436/EC,Euratom (1). (2) Taking into account the need for an adequate level of predictability for preparing and implementing medium-term investments, the duration of the multiannual financial framework (MFF) should be set at seven years starting on 1 January 2014. A review will take place in 2016 at the latest, following the European Parliament elections. This will allow the institutions, including the European Parliament elected in 2014, to reassess the priorities. The results of this review should be taken into account in any revision of this Regulation for the remaining years of the MFF. This arrangement is hereinafter referred to as \"review/revision\". (3) In the context of the mid-term review/revision of the MFF, the European Parliament, the Council and the Commission agree to jointly examine the most suitable duration for the subsequent MFF before the Commission presents its proposals with a view to striking the right balance between the duration of the respective terms of office of the members of the European Parliament and the European Commission - and the need for stability for programming cycles and investment predictability. (4) Specific and maximum possible flexibility should be implemented to allow the Union to fulfil its obligations in compliance with Article 323 of the Treaty on the Functioning of the European Union (TFEU). (5) The following special instruments are necessary to allow the Union to react to specified unforeseen circumstances, or to allow the financing of clearly identified expenditure which cannot be financed within the limits of the ceilings available for one or more headings as laid down in the MFF, thereby facilitating the budgetary procedure: the Emergency Aid Reserve, the European Union Solidarity Fund, the Flexibility Instrument, the European Globalisation Adjustment Fund, the Contingency Margin, the specific flexibility to tackle youth unemployment and strengthen research and the global margin for commitments for growth and employment, in particular youth employment. Specific provision should therefore be made for a possibility to enter commitment appropriations into the budget over and above the ceilings set out in the MFF where it is necessary to use special instruments. (6) If it is necessary to mobilise the guarantees given under the general budget of the Union for the loans provided under the Balance of Payment Facility or the European Financial Stabilisation Mechanism set out in Council Regulation (EC) No 332/2002 (2) and in Council Regulation (EU) No 407/2010 (3), respectively, the necessary amount should be mobilised over and above the ceilings of the commitments and payments appropriations of the MFF, while respecting the own-resources ceiling. (7) The MFF should be laid down in 2011 prices. The rules for technical adjustments to the MFF to recalculate the ceilings and margins available should also be laid down. (8) The MFF should not take account of budget items financed by assigned revenue within the meaning of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (4) (the \"Financial Regulation\"). (9) This Regulation might need to be revised in case of unforeseen circumstances that cannot be dealt with within ceilings established as part of the MFF. It is therefore necessary to provide for revision of the MFF in such cases. (10) Rules should be laid down for other situations that might require the MFF to be adjusted or revised. Such adjustments or revisions might be related to the implementation of the budget, measures linking effectiveness of funds to sound economic governance, revision of the Treaties, enlargements, the reunification of Cyprus, or delayed adoption of new rules governing certain policy areas. (11) The national envelopes for cohesion policy are established on the basis of the statistical data and forecasts used for the July 2012 update of the Commission proposal for this Regulation. Given the forecasting uncertainties and the impact for the capped Member States, and to take account of the particularly difficult situation of Member States suffering from the crisis, the Commission will, in 2016, review all Member States' total allocations under the \"Investment for growth and jobs\" goal of cohesion policy for the years 2017 to 2020. (12) It is necessary to provide for general rules on interinstitutional cooperation in the budgetary procedure. (13) Specific rules are also necessary for dealing with large-scale infrastructure projects whose lifetime extends well beyond the period set for the MFF. It is necessary to establish maximum amounts for the contributions from the general budget of the Union to those projects, thereby ensuring that they do not have any impact on other projects financed from that budget. (14) The Commission should present a proposal for a new multiannual financial framework before 1 January 2018, to enable the institutions to adopt it sufficiently in advance of the start of the subsequent multiannual financial framework. This Regulation should continue to apply in the event that a new financial framework is not adopted before the end of the term of the MFF laid down in this Regulation. (15) The Economic and Social Committee and the Committee of the Regions were consulted and have adopted opinions (5), HAS ADOPTED THIS REGULATION: CHAPTER 1 General provisions Article 1 Multiannual Financial Framework The multiannual financial framework for the period 2014 to 2020 (the \"MFF\") is set out in the Annex. Article 2 Mid-term review/revision of the MFF By the end of 2016 at the latest, the Commission shall present a review of the functioning of the MFF taking full account of the economic situation at that time as well as the latest macroeconomic projections. This compulsory review shall, as appropriate, be accompanied by a legislative proposal for the revision of this Regulation in accordance with the procedures set out in the TFEU. Without prejudice to Article 7 of this Regulation, preallocated national envelopes shall not be reduced through such a revision. Article 3 Compliance with the ceilings of the MFF 1. The European Parliament, the Council and the Commission shall, during each budgetary procedure and when implementing the budget for the year concerned, comply with the annual expenditure ceilings set out in the MFF. The sub-ceiling for Heading 2 as set out in the Annex is established without prejudice to the flexibility between the two pillars of the Common Agricultural Policy (CAP). The adjusted ceiling to be applied to pillar I of the CAP following the transfers between the European Agricultural Fund for Rural Development and direct payments shall be laid down in the relevant legal act and the MFF shall be adjusted accordingly under the technical adjustment provided for in Article 6(1) of this Regulation. 2. The special instruments provided for in Articles 9 to 15 shall ensure the flexibility of the MFF and shall be laid down in order to allow the budget procedure to run smoothly. The commitment appropriations may be entered in the budget over and above the ceilings of the relevant headings laid down in the MFF where it is necessary to use the resources from the Emergency Aid Reserve, the European Union Solidarity Fund, the Flexibility Instrument, the European Globalisation Adjustment Fund, the Contingency Margin, the specific flexibility to tackle youth unemployment and strengthen research and the global margin for commitments for growth and employment, in particular youth employment, in accordance with Council Regulation (EC) No 2012/2002 (6), Regulation (EC) No 1927/2006 of the European Parliament and of the Council (7), and the Interinstitutional Agreement between the European Parliament, the Council and the Commission (8). 3. Where a guarantee for a loan covered by the general budget of the Union in accordance with Regulation (EC) No 332/2002 or Regulation (EU) No 407/2010 needs to be mobilised, it shall be over and above the ceilings laid down in the MFF. Article 4 Respect of own resources ceiling 1. For each of the years covered by the MFF, the total appropriations for payments required, after annual adjustment and taking account of any other adjustments and revisions as well as the application of paragraphs 2 and 3 of Article 3, shall not be such as to produce a call-in rate for own resources that exceeds the own resources ceiling set in accordance with Decision 2007/436/EC, Euratom. 2. Where necessary, the ceilings set in the MFF shall be lowered by way of revision in order to ensure compliance with the own-resources ceiling set in accordance with Decision 2007/436/EC, Euratom. Article 5 Global margin for payments 1. Every year, starting in 2015, as part of the technical adjustment referred to in Article 6, the Commission shall adjust the payment ceiling for the years 2015-2020 upwards by an amount equivalent to the difference between the executed payments and the MFF payment ceiling of the year n-1. 2. The annual adjustments shall not exceed the following maximum amounts (in 2011 prices) for the years 2018-2020 as compared to the original payment ceiling of the relevant years: 2018 - EUR 7 billion 2019 - EUR 9 billion 2020 - EUR 10 billion. 3. Any upward adjustment shall be fully offset by a corresponding reduction of the payment ceiling for year n-1. Article 6 Technical adjustments 1. Each year the Commission, acting ahead of the budgetary procedure for year n+1, shall make the following technical adjustments to the MFF: (a) revaluation, at year n+1 prices, of the ceilings and of the overall figures for appropriations for commitments and appropriations for payments; (b) calculation of the margin available under the own-resources ceiling set in accordance with Decision 2007/436/EC, Euratom; (c) calculation of the absolute amount of the Contingency Margin provided for in Article 13; (d) calculation of the global margin for payments provided for in Article 5; (e) calculation of the global margin for commitments provided for in Article 14. 2. The Commission shall make the technical adjustments referred to in paragraph 1 on the basis of a fixed deflator of 2 % per year. 3. The Commission shall communicate the results of the technical adjustments referred to in paragraph 1 and the underlying economic forecasts to the European Parliament and the Council. 4. Without prejudice to Article 7 and 8, no further technical adjustments shall be made in respect of the year concerned, either during the year or as ex-post corrections during subsequent years. Article 7 Adjustment of cohesion policy envelopes 1. To take account of the particularly difficult situation of Member States suffering from the crisis, the Commission shall in 2016, together with the technical adjustment for the year 2017, review all Member States' total allocations under the \"Investment for growth and jobs\" goal of cohesion policy for the years 2017 to 2020, applying the allocation method defined in the relevant basic act on the basis of the then available most recent statistics and of the comparison, for the capped Member States, between the cumulated national GDP observed for the years 2014 and 2015 and the cumulated national GDP estimated in 2012. It shall adjust those total allocations whenever there is a cumulative divergence of more than +/- 5 %. 2. The adjustments required shall be spread in equal proportions over the years 2017-2020 and the corresponding ceilings of the MFF shall be modified accordingly. The payment ceilings shall also be modified accordingly to ensure an orderly progression in relation to the appropriations for commitments. 3. In its technical adustment for the year 2017, following the mid-term review of the eligibility of Member States for the Cohesion Fund provided for in Article 90(5) of Regulation (EU) No 1303/2013 of the European Parliament and of the Council (9), in case a Member State either becomes newly eligible to the Cohesion Fund or loses its existing eligibility, the Commission shall add or subtract the resulting amounts to or from the funds allocated to the Member State for the years 2017 to 2020. 4. The required adjustments resulting from paragraph 3 shall be spread in equal proportions over the years 2017-2020 and the corresponding ceilings of the MFF shall be modified accordingly. The payment ceilings shall also be modified accordingly to ensure an orderly progression in relation to the appropriations for commitments. 5. The total net effect, whether positive or negative, of the adjustments referred to in paragraphs 1 and 3 shall not exceed EUR 4 billion. Article 8 Adjustments related to measures linking effectiveness of funds to sound economic governance In the case of the lifting by the Commission of a suspension of budgetary commitments concerning the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development or the European Maritime and Fisheries Fund in the context of measures linking effectiveness of funds to sound economic governance, the Commission, in accordance with the relevant basic act, shall transfer the suspended commitments to the following years. Suspended commitments of year n may not be re-budgeted beyond year n+3. CHAPTER 2 Special instruments Article 9 Emergency Aid Reserve 1. The Emergency Aid Reserve is intended to allow for a rapid response to specific aid requirements of third countries following events which could not be foreseen when the budget was established, first and foremost for humanitarian operations, but also for civil crisis management and protection, and situations of particular pressure resulting from migratory flows at the Union's external borders where circumstances so require. 2. The annual amount of the Reserve is fixed at EUR 280 million (2011 prices) and may be used up to year n+1 in accordance with the Financial Regulation. The Reserve shall be entered in the general budget of the Union as a provision. The portion of the annual amount stemming from the previous year shall be drawn on first. That portion of the annual amount from year n which is not used in year n+1 shall lapse. Article 10 European Union Solidarity Fund 1. The European Union Solidarity Fund is intended to allow financial assistance in the event of major disasters occurring on the territory of a Member State or of a candidate country, as defined in the relevant basic act. There shall be a ceiling on the annual amount available for that Fund of EUR 500 million (2011 prices). On 1 October each year, at least one quarter of the annual amount shall remain available in order to cover needs arising until the end of that year. The portion of the annual amount not entered in the budget may be used up to year n+1. The portion of the annual amount stemming from the previous year shall be drawn on first. That portion of the annual amount from year n which is not used in year n+1 shall lapse. 2. In exceptional cases and if the remaining financial resources available in the European Union Solidarity Fund in the year of occurrence of the disaster, as defined in the relevant basic act, are not sufficient to cover the amount of assistance considered necessary by the European Parliament and the Council, the Commission may propose that the difference be financed through the annual amounts available for the following year. Article 11 Flexibility Instrument 1. The Flexibility Instrument is intended to allow the financing, for a given financial year, of clearly identified expenditure which could not be financed within the limits of the ceilings available for one or more other headings. There shall be a ceiling on the annual amount available for the Flexibility Instrument of EUR 471 million (2011 prices). 2. The unused portion of the annual amount of the Flexibility Instrument may be used up to year n+3. The portion of the annual amount stemming from previous years shall be used first, in order of age. That portion of the annual amount from year n which is not used in year n+3 shall lapse. Article 12 European Globalisation Adjustment Fund 1. The European Globalisation Adjustment Fund, the objectives and scope of which are defined in Regulation (EC) No 1927/2006 of the European Parliament and of the Council, shall not exceed a maximum annual amount of EUR 150 million (2011 prices). 2. The appropriations for the European Globalisation Adjustment Fund shall be entered in the general budget of the Union as a provision. Article 13 Contingency Margin 1. A Contingency Margin of up to 0,03 % of the Gross National Income of the Union shall be constituted outside the ceilings of the MFF, as a last-resort instrument to react to unforeseen circumstances. It may be mobilised only in relation to an amending or annual budget. 2. Recourse to the Contingency Margin shall not exceed, at any given year, the maximum amount foreseen in the annual technical adjustment of the MFF, and shall be consistent with the own-resources ceiling. 3. Amounts made available through the mobilisation of the Contingency Margin shall be fully offset against the margins in one or more MFF headings for the current or future financial years. 4. The amounts thus offset shall not be further mobilised in the context of the MFF. Recourse to the Contingency Margin shall not result in exceeding the total ceilings of commitment and payment appropriations laid down in the MFF for the current and future financial years. Article 14 Global margin for commitments for growth and employment, in particular youth employment 1. Margins left available below the MFF ceilings for commitment appropriations for the years 2014-2017 shall constitute a Global MFF Margin for commitments, to be made available over and above the ceilings established in the MFF for the years 2016 to 2020 for policy objectives related to growth and employment, in particular youth employment. 2. Each year, as part of the technical adjustment provided for in Article 6, the Commission shall calculate the amount available. The Global MFF Margin or part thereof may be mobilised by the European Parliament and the Council in the framework of the budgetary procedure pursuant to Article 314 TFEU. Article 15 Specific flexibility to tackle youth unemployment and strengthen research Up to EUR 2 543 million(in 2011 prices) may be frontloaded in 2014 and 2015, as part of the annual budgetary procedure, for specified policy objectives relating to youth employment, research, ERASMUS in particular for apprenticeships, and Small and Medium-sized Enterprises. That amount shall be fully offset against appropriations within and/or between headings in order to leave unchanged the total annual ceilings for the period 2014-2020 and the total allocation per heading or sub-heading over the period. Article 16 Contribution to the financing of large-scale projects 1. A maximum amount of EUR 6 300 million (in 2011 prices) shall be available for the European satellite navigation programmes (EGNOS and Galileo) from the general budget of the Union for the period 2014-2020. 2. A maximum amount of EUR 2 707 million (in 2011 prices) shall be available for the International Thermonuclear Experimental Reactor project (ITER) from the general budget of the Union for the period 2014-2020. 3. A maximum amount of EUR 3 786 million (in 2011 prices) shall be available for Copernicus (the European Earth Observation Programme) from the general budget of the Union for the period 2014-2020. CHAPTER 3 Revision Article 17 Revision of the MFF 1. Without prejudice to Article 4(2), Articles 18 to 22 and Article 25, in the event of unforeseen circumstances, the MFF may be revised in compliance with the own-resources ceiling set in accordance with Decision 2007/436/EC, Euratom. 2. As a general rule, any proposal for a revision of the MFF in accordance with paragraph 1 shall be presented and adopted before the start of the budgetary procedure for the year or the first of the years concerned. 3. Any proposal for revision of the MFF in accordance with paragraph 1 shall examine the scope for reallocating expenditure between the programmes covered by the heading concerned by the revision, with particular reference to any expected under-utilisation of appropriations. The objective should be that a significant amount, in absolute terms and as a percentage of the new expenditure planned, shall be within the existing ceiling for the heading. 4. Any revision of the MFF in accordance with paragraph 1 shall take into account the scope for offsetting any raising of the ceiling for one heading by the lowering of the ceiling for another. 5. Any revision of the MFF in accordance with paragraph 1 shall maintain an appropriate relationship between commitments and payments. Article 18 Revision related to implementation When notifying the European Parliament and the Council of the results of the technical adjustments to the MFF, the Commission shall present any proposals to revise the total appropriations for payments which it considers necessary, in the light of implementation, to ensure a sound management of the yearly payments ceilings and, in particular, their orderly progression in relation to the appropriations for commitments. The European Parliament and the Council shall decide on those proposals before 1 May of year n. Article 19 Revision following new rules or programmes for the Structural Funds, the Cohesion Fund the European Agricultural Fund for Rural Development, the European Maritim and Fisheries Fund, the Asylum and Migration Fund and the Internal Security Fund 1. In the event of the adoption after 1 January 2014 of new rules or programmes under shared management for the Structural Funds, the Cohesion Fund, the European Agricultural Fund for Rural Development, the European Maritime and Fisheries Fund, the Asylum and Migration Fund and the Internal Security Fund, the MFF shall be revised in order to transfer to subsequent years, in excess of the corresponding expenditure ceilings, allocations not used in 2014. 2. The revision concerning the transfer of unused allocation for the year 2014 shall be adopted before 1 May 2015. Article 20 Revision of the MFF in case of a revision of the Treaties Should a revision of the Treaties with budgetary implications occur between 2014 and 2020, the MFF shall be revised accordingly. Article 21 Revision of the MFF in the event of enlargement of the Union If there is an accession or accessions to the Union between 2014 and 2020, the MFF shall be revised to take account of the expenditure requirements resulting therefrom. Article 22 Revision of the MFF in the event of the reunification of Cyprus In the event of of the reunification of Cyprus between 2014 and 2020, the MFF shall be revised to take account of the comprehensive settlement of the Cyprus problem and the additional financial needs resulting from the reunification. Article 23 Interinstitutional cooperation in the budgetary procedure The European Parliament, the Council and the Commission (hereinafter \"the institutions\") shall take measures to facilitate the annual budgetary procedure. The institutions shall cooperate in good faith throughout the procedure with a view to reconciling their positions. The institutions shall, at all stages of the procedure, cooperate through appropriate interinstitutional contacts in order to monitor the progress of the work and analyse the degree of convergence. The institutions shall ensure that their respective calendars of work are coordinated as far as possible, in order to enable proceedings to be conducted in a coherent and convergent fashion, leading to the final adoption of the general budget of the Union. Trilogues may be held at all stages of the procedure and at different levels of representation, depending on the nature of the expected discussions. Each institution, in accordance with its own rules of procedure, shall designate its participants for each meeting, define its mandate for the negotiations and inform the other institutions in good time of the arrangements for the meetings. Article 24 Unity of the budget All expenditure and revenue of the Union and Euratom shall be included in the general budget of the Union in accordance with Article 7 of the Financial Regulation, including expenditure resulting from any relevant decision taken unanimously by the Council after consulting the European Parliament, in the framework of Article 332 TFEU. Article 25 Transition towards the next multiannual financial framework Before 1 January 2018, the Commission shall present a proposal for a new multiannual financial framework. If no Council regulation determining a new multiannual financial framework has been adopted before 31 December 2020, the ceilings and other provisions corresponding to the last year of the MFF shall be extended until a regulation determining a new financial framework is adopted. If a new Member State accedes to the Union after 2020, the extended financial framework shall, if necessary, be revised in order to take the accesion into account. Article 26 Entry into force This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 2 December 2013. For the Council The President E. GUSTAS (1) Council Decision 2007/436/EC, Euratom of 7 June 2007 on the system of the European Communities' own resources (OJ L 163, 23.6.2007, p. 17). (2) Council Regulation (EC) No 332/2002 of 18 February 2002 establishing a facility providing medium-term financial assistance for Member States' balances of payments (OJ L 53, 23.2.2002, p. 1). (3) Council Regulation (EU) No 407/2010 of 11 May 2010 establishing a European financial stabilisation mechanism (OJ L 118, 12.5.2010, p. 1). (4) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (5) Opinion of the European Economic and Social Committee on the 'Proposal for a Council Regulation laying down the multiannual financial framework for the years 2014-2020' (OJ C 229, 31.7.2012, p. 32); Opinion of the Committee of the Regions on 'New Multiannual Financial Framework post-2013' (OJ C 391, 18.12.2012, p. 31). (6) Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (OJ L 311, 14.11.2002, p. 3). (7) Regulation (EC) No 1927/2006 of the European Parliament and of the Council of 20 December 2006 on establishing the European Globalisation Adjustment Fund (JO L 406, 30.12.2006, p. 1). (8) Interinstitutional Agreement between the European Parliament, the Council and the Commission of 2 December 2013 on budgetary discipline, cooperation in budgetary matters and on sound financial management (OJ C 373, 20.12.2013, p. 1). (9) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund covered by the Common Strategic Framework and laying down general provisions on the European Regional Development Fund, the European Social Fund and the Cohesion Fund and repealing Council Regulation (EC) No 1083/2006 (See page 320 of this Official Journal.). ANNEX I MULTIANNUAL FINANCIAL FRAMEWORK (EU-28) (EUR million - 2011 prices) COMMITMENT APPROPRIATIONS 2014 2015 2016 2017 2018 2019 2020 Total 2014\u20132020 1. Smart and Inclusive Growth 60 283 61 725 62 771 64 238 65 528 67 214 69 004 450 763 1a: Competitiveness for growth and jobs 15 605 16 321 16 726 17 693 18 490 19 700 21 079 125 614 1b: Economic, social and territorial cohesion 44 678 45 404 46 045 46 545 47 038 47 514 47 925 325 149 2. Sustainable Growth: Natural Resources 55 883 55 060 54 261 53 448 52 466 51 503 50 558 373 179 of which: Market related expenditure and direct payments 41 585 40 989 40 421 39 837 39 079 38 335 37 605 277 851 3. Security and citizenship 2 053 2 075 2 154 2 232 2 312 2 391 2 469 15 686 4. Global Europe 7 854 8 083 8 281 8 375 8 553 8 764 8 794 58 704 5. Administration 8 218 8 385 8 589 8 807 9 007 9 206 9 417 61 629 of which: Administrative expenditure of the institutions 6 649 6 791 6 955 7 110 7 278 7 425 7 590 49 798 6. Compensations 27 0 0 0 0 0 0 27 TOTAL COMMITMENT APPROPRIATIONS 134 318 135 328 136 056 137 100 137 866 139 078 140 242 959 988 as a percentage of GNI 1,03 % 1,02 % 1,00 % 1,00 % 0,99 % 0,98 % 0,98 % 1,00 % TOTAL PAYMENT APPROPRIATIONS 128 030 131 095 131 046 126 777 129 778 130 893 130 781 908 400 as a percentage of GNI 0,98 % 0,98 % 0,97 % 0,92 % 0,93 % 0,93 % 0,91 % 0,95 % Margin available 0,25 % 0,25 % 0,26 % 0,31 % 0,30 % 0,30 % 0,32 % 0,28 % Own Resources Ceiling as a percentage of GNI 1,23 % 1,23 % 1,23 % 1,23 % 1,23 % 1,23 % 1,23 % 1,23 %", "summary": "Multiannual EU budget (2014-2020) Multiannual EU budget (2014-2020) SUMMARY OF: Regulation (EU, Euratom) No 1311/2013 \u2014 the EU\u2019s multiannual financial framework for the years 2014-2020 WHAT IS THE AIM OF THE REGULATION? It sets out the maximum annual amounts that can be spent on the EU\u2019s different policy areas over the 2014-2020 period. KEY POINTS The EU adopted the 7-year plan for the 2014-2020 period in December 2013. The multiannual financial framework (MFF) amounts to \u20ac960 billion in commitments (legal promise to provide finance, assuming certain conditions are met) and \u20ac908.4 billion in payments (actual transfers to beneficiaries) over the 7-year period, expressed in constant prices of the year 2011.The MFF regulation lays down ceilings (maximum amounts) for each category of EU spending over the period. These must be respected when agreeing the EU\u2019s annual budgets.The 2014-2020 MFF is broken down into headings, as follows. Heading 1 - Smart and inclusive growth: \u20ac450.763 billion (of which \u20ac325.149 billion for economic, social and territorial cohesion). Heading 2 - Sustainable growth: natural resources: \u20ac373.179 billion. Heading 3 - Security and citizenship: \u20ac15.686 billion. Heading 4 - Global Europe: \u20ac58.704 billion. Heading 5 - Administration: \u20ac61.629 billion. A central focus of the 2014-2020 MFF is on growth and employment. Subheading 1a on \u2018competitiveness\u2019 has increased by over 37% compared with the previous 2007-2013 MFF, reflecting the importance of this political priority. However, the new MFF is smaller than its predecessor, given that many EU countries face budgetary pressures on the home front. The MFF regulation also provides for special instruments that allow the EU to react to specified, unforeseen circumstances. It can also allow the financing of clearly identified expenditure that cannot be financed within the limits of the ceilings that are available for one or more headings, notably: the Emergency Aid Reserve (used to finance, for example, humanitarian aid and civilian crisis management); the European Union Solidarity Fund; the Flexibility Instrument; the European Globalisation Adjustment Fund; the Contingency Margin (a last-resort instrument to react to unforeseen circumstances). An interinstitutional agreement on budgetary discipline, cooperation in budgetary matters and sound financial management was also agreed between the European Parliament, the Council and the European Commission. This should rationalise the annual budgetary procedure and complement the MFF regulation. Reallocation of 2014 unused commitments The MFF regulation provides that in the event of the adoption of programmes under shared management for the Structural and Investment Funds, the European Agricultural Fund for Rural Development, the European Maritime and Fisheries Fund, the Asylum, Migration and Integration Fund and the Internal Security Fund after 1 January 2014, the MFF should be revised to reallocate the amounts not used in 2014 to subsequent years.As a result, the MFF regulation has been revised so as to allow the transfer of 2014\u2019s unused commitments: \u20ac16.5 billion to 2015, \u20ac4.5 billion to 2016 and \u20ac0.1 billion to 2017. This was due to the late adoption of 300 out of the 645 EU programmes in areas covered by the abovementioned EU funds.The revision of the EU\u2019s MFF keeps the total expenditure ceilings unchanged and involves no additional money. Review The MFF had to be reviewed no later than in 2016 to allow the European Parliament (elected in 2014), the Council and the Commission (appointed in 2014) to reassess the priorities for the remaining years of the framework. This assessment was undertaken in light of the economic situation at the time as well as of the latest macroeconomic projections. Following the mid-term reviewRegulation (EU, Euratom) No 1311/2013 was amended by Regulation (EU, Euratom) 2017/1123 in 2017. The revised MFF increases the resources earmarked for the EU\u2019s main priorities by \u20ac6.01 billion for the years 2017-2020, as follows: \u20ac2.08 billion for boosting growth and creating jobs through programmes such as the youth employment initiative (+ \u20ac1.2 billion), Horizon 2020 (+ \u20ac200 million), and Erasmus+ (+ \u20ac100 million); \u20ac2.55 billion for addressing migration, enhancing security and strengthening external border control; \u20ac1.39 billion for tackling the root causes of migration. Each year, ahead of the budgetary procedure for the following year, the Commission makes a technical adjustment to the MFF in line with movements in the EU\u2019s gross national income and prices. The results of this adjustment for 2018 were first communicated to the European Parliament and the Council in May 2017. However, these results were subsequently revised to take into account the 2017 amendment to Regulation (EU, Euratom) No 1311/2013 and were communicated to the European Parliament and the Council in September 2017. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND For more information, see: Multiannual financial framework (European Commission) Multiannual financial framework (Council). MAIN DOCUMENT Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, pp. 884-891) Successive amendments to Regulation (EU, Euratom) No 1311/2013 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Communication from the Commission to the Council and the European Parliament \u2014 Technical adjustment of the financial framework for 2018 in line with movements in GNI (ESA 2010) (Article 6 of Council Regulation No 1311/2013 laying down the multiannual financial framework for the years 2014-2020) updating and replacing Communication COM(2017)220 final (COM(2017) 473 final, 15.9.2017) Interinstitutional agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (OJ C 373, 20.12.2013, pp. 1-11) last update 29.11.2017"}
{"article": "13.7.2021 EN Official Journal of the European Union L 247/1 REGULATION (EU) 2021/1139 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2021 establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 42, Article 43(2), Article 91(1), Article 100(2), Article 173(3), Article 175, Article 188, Article 192(1), Article 194(2), Article 195(2) and Article 349 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The European Maritime, Fisheries and Aquaculture Fund (the \u2018EMFAF\u2019) should be established for the period from 1 January 2021 to 31 December 2027 in order to align its duration with that of the multiannual financial framework (the \u2018MFF 2021-2027\u2019) laid down in Council Regulation (EU, Euratom) 2020/2093 (4). This Regulation should lay down the priorities of the EMFAF, its budget and the specific rules for providing Union funding, complementing the general rules applicable to the EMFAF under Regulation (EU) 2021/1060 of the European Parliament and of the Council (5). The EMFAF should aim to channel funding from the Union budget to support the Common Fisheries Policy (CFP), the Union\u2019s maritime policy and the Union\u2019s international commitments in the field of ocean governance. Such funding is a key enabler for sustainable fisheries and the conservation of marine biological resources, for food security through the supply of seafood products, for the growth of a sustainable blue economy and for healthy, safe, secure, clean and sustainably managed seas and oceans. (2) As a global ocean actor and one of the world\u2019s largest producers of seafood, the Union has a strong responsibility to protect, conserve and sustainably use the oceans and their resources. Indeed, preserving seas and oceans is vital for a rapidly growing world population. It is also of socio-economic interest for the Union as a sustainable blue economy boosts investments, jobs and growth, fosters research and innovation and contributes to energy security through ocean energy. Moreover, efficient border control and the global fight against maritime crime are essential for safe and secure seas and oceans, thereby addressing citizens\u2019 security concerns. (3) Regulation (EU) 2021/1060 has been adopted in order to improve the coordination and harmonise the implementation of support from Funds under shared management (the \u2018Funds\u2019), with the main aim of simplifying policy delivery in a coherent way. That Regulation applies to the part of the EMFAF under shared management. The Funds pursue complementary objectives and share the same management mode. Therefore, Regulation (EU) 2021/1060 sets out a series of common general objectives and general principles such as partnership and multi-level governance. It also contains the common elements of strategic planning and programming, including provisions on the Partnership Agreement to be concluded with each Member State, and sets out a common approach to the performance orientation of the Funds. Accordingly, it sets out enabling conditions, a performance review and arrangements for monitoring, reporting and evaluation. Furthermore, it sets out common provisions with regard to eligibility rules, and special arrangements are established for financial instruments, for the use of InvestEU established by Regulation (EU) 2021/523 of the European Parliament and of the Council (6), for community-led local development (CLLD) and for financial management. Some management and control arrangements are also common to all the Funds. Complementarities between the Funds, including the EMFAF, and other Union programmes should be described in the Partnership Agreement, in accordance with Regulation (EU) 2021/1060. (4) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (7) (the \u2018Financial Regulation\u2019) applies to the EMFAF. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (5) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union (TFEU) apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, prizes, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (6) Under direct management, the EMFAF should develop synergies and complementarities with other relevant Union funds and programmes. It should also allow financing in the form of financial instruments within blending operations implemented under Regulation (EU) 2021/523. (7) Support under the EMFAF should have a clear European added value, inter alia, by addressing market failures or suboptimal investment situations in a proportionate manner, and should not duplicate or crowd out private financing or distort competition in the internal market. (8) Articles 107, 108 and 109 TFEU should apply to the aid granted by Member States to undertakings in the fishery and aquaculture sector under this Regulation. Nevertheless, given the specific characteristics of that sector, those Articles should not apply to payments made by Member States pursuant to this Regulation and falling within the scope of Article 42 TFEU. (9) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the priorities set for the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. This should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (10) The MFF 2021-2027 provides that the Union budget is to continue to support fisheries and maritime policies. The EMFAF budget should amount, in current prices, to EUR 6 108 000 000. EMFAF resources should be split between shared management and direct and indirect management. EUR 5 311 000 000 should be allocated to support under shared management and EUR 797 000 000 to support under direct and indirect management. In order to ensure stability, in particular with regard to the achievement of the objectives of the CFP, the definition of national allocations under shared management for the 2021-2027 programming period should be based on the 2014-2020 shares under Regulation (EU) No 508/2014 of the European Parliament and of the Council on the European Maritime and Fisheries Fund (8) (the \u2018EMFF\u2019). Specific amounts should be reserved for the outermost regions, for control and enforcement, and for collection and processing of data for fisheries management and scientific purposes, while amounts for certain investments in fishing vessels and for permanent and temporary cessation of fishing activities should be capped. (11) Europe\u2019s maritime sector employs over 5 million people, generating almost EUR 750 000 000 000 in turnover and EUR 218 000 000 000 in gross added value per year, with a potential to create many more jobs. The output of the global ocean economy is estimated at EUR 1 300 000 000 000 today and this could more than double by 2030. The need to meet CO2 emission targets, increase resource efficiency and reduce the environmental footprint of the blue economy has been a significant driving force for innovation in other sectors such as marine equipment, shipbuilding, ocean observation, dredging, coastal protection and marine construction. Investment in the maritime economy has been provided through Union structural funds, in particular the European Regional Development Fund (ERDF) and the EMFAF. New investment tools such as InvestEU could be utilised to meet the growth potential of the maritime sector. (12) The EMFAF should be based on four priorities: fostering sustainable fisheries and the restoration and conservation of aquatic biological resources; fostering sustainable aquaculture activities, and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union; enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities; strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed. Those priorities should be pursued through shared, direct and indirect management. (13) The EMFAF should be based on a simple architecture without predefining measures and detailed eligibility rules at Union level in an overly prescriptive manner. Instead, broad specific objectives should be described under each priority. Member States should therefore prepare their programmes indicating therein the most appropriate means for achieving those objectives. A variety of measures identified by the Member States in those programmes might be supported under the rules set out in this Regulation and Regulation (EU) 2021/1060, provided they are covered by the specific objectives identified in this Regulation. However, it is necessary to set out a list of ineligible operations so as to avoid detrimental impact in terms of fisheries conservation. Moreover, investments and compensation for the fleet should be strictly conditional upon their consistency with the conservation objectives of the CFP. (14) The United Nations 2030 Agenda for Sustainable Development (the \u20182030 Agenda\u2019) identified conservation and sustainable use of oceans as one of the 17 Sustainable Development Goals (SDGs), namely SDG 14 (\u2018Conserve and sustainably use the oceans, seas and marine resources for sustainable development\u2019). The Union is fully committed to that goal and its implementation. In that context, it has committed to promote a sustainable blue economy which is consistent with maritime spatial planning, the conservation of biological resources and the achievement of a good environmental status as set out in Directive 2008/56/EC of the European Parliament and of the Council (9), as well as to prohibit certain forms of fisheries subsidies which contribute to overcapacity and overfishing, to eliminate subsidies that contribute to illegal, unreported and unregulated (IUU) fishing and to refrain from introducing new such subsidies. The latter outcome should result from the negotiations within the World Trade Organisation (WTO) on fisheries subsidies. In addition, in the course of the WTO negotiations at the 2002 World Summit of Sustainable Development and at the 2012 United Nations Conference on Sustainable Development (Rio+20), the Union has committed to eliminate subsidies contributing to fisheries overcapacity and overfishing. (15) Reflecting the importance of tackling climate change in line with the Union\u2019s commitments to implement the Paris Agreement, and the commitment to the United Nations Sustainable Development Goals, the actions under this Regulation should contribute to the achievement of a 30 % target of all expenditure under the MFF 2021-2027 spent on mainstreaming climate objectives and should contribute to the ambition of providing 7,5 % of annual spending under the MFF 2021-2027 to biodiversity objectives in 2024 and 10 % of annual spending under the MFF 2021-2027 to biodiversity objectives in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. (16) The EMFAF should contribute to the achievement of the environmental and climate change mitigation and adaptation objectives of the Union. That contribution should be tracked through the application of Union environmental and climate markers and reported regularly in accordance with Regulation (EU) 2021/1060. (17) In accordance with Article 42 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (10), Union financial assistance under the EMFAF should be conditional upon compliance with the rules of the CFP. Applications from operators that have committed serious infringements of the rules of the CFP should not be admissible. (18) In order to address the specific conditions of the CFP referred to in Regulation (EU) No 1380/2013 and to contribute to compliance with the rules of the CFP, provisions additional to the rules on interruption, suspension and financial corrections as set out in Regulation (EU) 2021/1060 should be laid down. Where a Member State has failed to comply with its obligations under the CFP, or where the Commission has evidence that suggests such lack of compliance, the Commission should, as a precautionary measure, be allowed to interrupt payment deadlines. In addition to the possibility of interruption of the payment deadline, and in order to avoid an evident risk of paying out ineligible expenditure, the Commission should be allowed to suspend payments and impose financial corrections in cases of serious non-compliance with the rules of the CFP by a Member State. (19) Steps have been taken over the last few years towards bringing fish stocks back to healthy levels, towards increasing the profitability of the Union\u2019s fishing industry and towards conserving marine ecosystems. However, substantial challenges remain to fully achieve the socio-economic and environmental objectives of the CFP, in particular the objectives of restoring and maintaining populations of harvested species above levels which can produce the maximum sustainable yield (MSY), of eliminating unwanted catches and of establishing fish stock recovery areas. Achieving those objectives requires continued support beyond 2020, particularly in sea basins where progress has been slower. (20) The EMFAF should contribute to achieving the environmental, economic, social and employment objectives of the CFP, as set out in Article 2 of Regulation (EU) No 1380/2013, in particular the objectives of restoring and maintaining populations of harvested species above levels which can produce MSY, of avoiding and reducing, as far as possible, unwanted catches and of minimising the negative impact of fishing activities on the marine ecosystem. Such support should ensure that fishing activities are environmentally sustainable in the long term and are managed in a way that is consistent with the objectives set out in Article 2 of Regulation (EU) No 1380/2013, with a view to achieving economic, social and employment benefits, contributing to the availability of healthy food supplies and contributing to a fair standard of living for those who depend on fishing activities, bearing in mind coastal fisheries and socio-economic aspects. That support should include innovation and investments in low-impact, selective, climate-resilient and low-carbon fishing practices and techniques. (21) Fisheries are vital to the livelihood and cultural heritage of many coastal communities in the Union, in particular where small-scale coastal fishing plays an important role. With the average age in many fishing communities being over 50, generational renewal and diversification of activities remain a challenge. In particular, the creation and development of new economic activities in the fisheries sector by young fishers is financially challenging and constitutes an element that should be considered in the allocation and targeting of funds under the EMFAF. Such development is essential for the competitiveness of the fisheries sector in the Union. Consequently, support for young fishers starting up fishing activities should be made available in order to facilitate their establishment. In order to ensure the viability of new economic activities supported under the EMFAF, support should be made conditional upon the acquisition of adequate experience or qualifications. Where support for business start-up is granted for the acquisition of a fishing vessel, it should only contribute to the acquisition of the first fishing vessel or of a controlling share thereof. (22) Avoiding unwanted catches is one of the main challenges of the CFP. In that respect, the legal obligation to land all catches has entailed significant and important changes in fishing practices for the sector, sometimes with an important financial cost. It should therefore be possible for the EMFAF to support innovation and investments that contribute to the full implementation of the landing obligation, as well as the development and implementation of conservation measures contributing to selectivity. It should be possible to grant a higher aid intensity rate to investments in selective fishing gear, in the improvement of port infrastructures and in the marketing of unwanted catches, than the one that applies to other operations. It should also be possible to grant a maximum aid intensity rate of 100 % to the design, development, monitoring, evaluation and management of transparent systems for exchanging fishing opportunities between Member States (\u2018quota swaps\u2019), in order to mitigate the \u2018choke species\u2019 effect caused by the landing obligation. (23) It should be possible for the EMFAF to support innovation and investments on board Union fishing vessels. That support should include actions which aim to improve health, safety and working conditions, energy efficiency and the quality of catches. It should not include the acquisition of equipment that increases the ability of a fishing vessel to find fish. Such support should also not lead to an increase in fishing capacity of any individual vessel, except if it directly results from an increase in gross tonnage of a fishing vessel that is necessary for improving safety, working conditions or energy efficiency. In those cases, the increase in fishing capacity of the individual vessel should be compensated for by the prior withdrawal of at least the same amount of fishing capacity without public aid from the same fleet segment or from a fleet segment where the fishing capacity is not in balance with the available fishing opportunities, in order not to lead to any increase in fishing capacity at fleet level. Moreover, support should not be granted simply for complying with requirements that are obligatory under Union law, with the exception of requirements imposed by a Member State to give effect to optional provisions under Council Directive (EU) 2017/159 (11) and in relation to the purchase, installation and management of certain equipment for control purposes. Under an architecture without prescriptive measures, it should be up to Member States to lay down the precise eligibility rules for those investments. With regard to health, safety and working conditions on board fishing vessels, a higher aid intensity rate than the one that applies to other operations should be allowed. (24) It is necessary to establish specific eligibility rules for certain other investments supported by the EMFAF in the fishing fleet, so as to prevent those investments from contributing to overcapacity or overfishing. In particular, support for the first acquisition of a second-hand vessel by a young fisher and for the replacement or the modernisation of the engine of a fishing vessel should also be subject to conditions, including that the vessel belongs to a fleet segment which is in balance with the fishing opportunities available to that segment and that the new or modernised engine does not have more power in kilowatts (kW) than that of the engine being replaced. (25) Investment in human capital plays an essential role in the competitiveness and economic performance of the fishery, aquaculture and maritime sectors. Therefore, it should be possible for the EMFAF to support advisory services, cooperation between scientists and fishers, professional training, lifelong learning, as well as the promotion of social dialogue and the dissemination of knowledge. (26) Fisheries control is of the utmost importance for the implementation of the CFP. Therefore, the EMFAF should support, under shared management, the development and implementation of a Union fisheries control system as set out in Council Regulation (EC) No 1224/2009 (12). Certain obligations established in that Regulation justify specific support from the EMFAF, namely compulsory vessel tracking and electronic reporting systems, compulsory remote electronic monitoring systems and the compulsory continuous measurement and recording of propulsive engine power. In addition, investments by Member States in control assets could also be used for the purposes of maritime surveillance and cooperation on coast guard functions. (27) The success of the CFP is dependent on the availability of scientific advice for the management of fisheries, and hence on the availability of data on fisheries. In the light of the challenges and costs of obtaining reliable and complete data, it is necessary to support Member States\u2019 actions to collect and process data in line with Regulation (EU) 2017/1004 of the European Parliament and of the Council (13) and to contribute to the best available scientific advice. That support should allow synergies with the collection and processing of other types of marine data. (28) The EMFAF should support an effective knowledge-based implementation and governance of the CFP under direct and indirect management through the provision of scientific advice, regional cooperation on conservation measures, the development and implementation of a Union fisheries control system, the functioning of Advisory Councils and voluntary contributions to international organisations. (29) In order to strengthen economically, socially and environmentally sustainable fishing activities, it should be possible for the EMFAF to support operations for the management of fisheries and fishing fleets in accordance with Articles 22 and 23 of, and Annex II to, Regulation (EU) No 1380/2013, as well as efforts by Member States to optimise the allocation of their available fishing capacity, taking into account the needs of their fleet, and without increasing their overall fishing capacity. (30) Given the challenges of achieving the conservation objectives of the CFP, support for fleet adaptation remains sometimes necessary with regard to certain fleet segments and sea basins. Such support should be tightly targeted to better fleet management and to the conservation and sustainable exploitation of marine biological resources, and aimed at achieving a balance between the fishing capacity and the available fishing opportunities. Therefore, it should be possible for the EMFAF to support the permanent cessation of fishing activities in fleet segments where the fishing capacity is not balanced with the available fishing opportunities. Such support should be a tool of the action plans for the adjustment of fleet segments with identified structural overcapacity, as provided for in Article 22(4) of Regulation (EU) No 1380/2013, and should be implemented either through the scrapping of the fishing vessel or through its decommissioning and retrofitting for other activities. Where the retrofitting would lead to an increased pressure of recreational fishing on the marine ecosystem, support should only be granted if it is in line with the CFP and with the objectives of the relevant multiannual plans. (31) In order to contribute to the conservation objectives of the CFP or to mitigate certain exceptional circumstances, it should be possible for the EMFAF to support compensation for the temporary cessation of fishing activities caused by the implementation of certain conservation measures, by the implementation of emergency measures, by the interruption, due to reasons of force majeure, of the application of a sustainable fisheries partnership agreement (SFPA), by a natural disaster, by an environmental incident or by a health crisis. Support in the event of temporary cessation caused by conservation measures should be granted only where, based on scientific advice, a reduction of fishing effort is needed in order to achieve the objectives set out in Article 2(2) and point (a) of Article 2(5) of Regulation (EU) No 1380/2013. (32) Given that fishers are exposed to increasing economic and environmental risks, inter alia due to climate change and price volatility, it should be possible for the EMFAF to support actions that strengthen the resilience of the fisheries sector, including through mutual funds, insurance instruments or other collective schemes which enhance the capacity of the sector to manage risks and respond to adverse events. (33) Small-scale coastal fishing is carried out by marine and inland fishing vessels of an overall length of less than 12 metres and not using towed fishing gear, and by fishers on foot, including shellfish gatherers. That sector represents nearly 75 % of all fishing vessels registered in the Union and nearly half of all employment in the fisheries sector. Operators from small-scale coastal fisheries are particularly dependent on healthy fish stocks for their main source of income. With the aim of encouraging sustainable fishing practice, the EMFAF should therefore give those operators preferential treatment, through a maximum 100 % aid intensity rate, except for operations relating to the first acquisition of a fishing vessel, the replacement or modernisation of an engine and operations that increase the gross tonnage of a fishing vessel for the purposes of improving safety, working conditions or energy efficiency. In addition, Member States should take into account in their programme the specific needs of small-scale coastal fishing and describe the types of actions considered for the development of small-scale coastal fishing. (34) The maximum EMFAF co-financing rate per specific objective should be 70 % of the eligible public expenditure, with the exception of compensation for additional costs in the outermost regions, for which it should be 100 %. (35) The maximum aid intensity rate should be 50 % of the total eligible expenditure, with the possibility, in certain cases, to set derogatory rates. (36) The outermost regions face specific challenges linked to their remoteness, topography and climate as referred to in Article 349 TFEU and also have specific assets on which to develop a sustainable blue economy. Therefore, for each outermost region, an action plan for the development of sustainable blue economy sectors, including sustainable fisheries and aquaculture, should be attached to the programme of the Member States concerned, and a financial allocation should be reserved to support the implementation of those action plans. It should also be possible for the EMFAF to support compensation for the additional costs which the operators from the outermost regions face due to the location or insularity of those regions. That support should be capped as a percentage of that overall financial allocation. In addition, a higher aid intensity rate than the one that applies to other operations should be applied in the outermost regions. It should be possible for Member States to grant additional financing for the implementation of that support. As State aid, such financing should be notified to the Commission, which may approve it under this Regulation as part of that support. (37) Under shared management, it should be possible for the EMFAF to support the protection and restoration of aquatic biodiversity and ecosystems, including in inland waters. For that purpose, support from the EMFAF should be available to compensate, inter alia, the passive collection by fishers of lost fishing gear and marine litter from the sea, including sargassum seaweed, and for investments in ports to provide adequate reception facilities for lost fishing gear and marine litter. Support should also be available for actions to achieve or maintain a good environmental status in the marine environment as set out in Directive 2008/56/EC, for the implementation of spatial protection measures established pursuant to that Directive, for the management, restoration and monitoring of Natura 2000 areas, in accordance with the prioritised action frameworks established pursuant to Council Directive 92/43/EEC (14), for the protection of species, in particular under Directive 92/43/EEC and Directive 2009/147/EC of the European Parliament and of the Council (15), as well as for the restoration of inland waters in accordance with the programme of measures established pursuant to Directive 2000/60/EC of the European Parliament and of the Council (16). Under direct management, the EMFAF should support the promotion of clean and healthy seas and the implementation of the European strategy for plastics in a circular economy developed in the Communication of the Commission of 16 January 2018, in line with the objective of achieving or maintaining a good environmental status in the marine environment. (38) Fisheries and aquaculture contribute to food security and nutrition. However, it is estimated that the Union currently imports more than 60 % of its supply of fishery products and is therefore highly dependent on third countries. An important challenge is to encourage the consumption of fish protein produced in the Union with high quality standards and available for consumers at affordable prices. (39) It should be possible for the EMFAF to support the promotion and the sustainable development of aquaculture, including freshwater aquaculture, for the farming of aquatic animals and plants for the production of food and other raw material. Complex administrative procedures in some Member States remain in place, such as difficult access to space and burdensome licensing procedures, which make it difficult for the sector to improve the image and competitiveness of farmed products. Support from the EMFAF should be consistent with the multiannual national strategic plans for aquaculture developed on the basis of Regulation (EU) No 1380/2013. In particular, support for environmental sustainability, productive investments, innovation, acquisition of professional skills, improvement of working conditions, and compensatory measures providing critical land and nature management services should be eligible. Public health actions, aquaculture stock insurance schemes and animal health and welfare actions should also be eligible. (40) Food security relies on efficient and well-organised markets, which improve the transparency, stability, quality and diversity of the supply chain, as well as consumer information. For that purpose, it should be possible for the EMFAF to support the marketing of fishery and aquaculture products, in line with the objectives set out in Regulation (EU) No 1379/2013 of the European Parliament and of the Council (17). In particular, support should be available for the creation of producer organisations, the implementation of production and marketing plans, the promotion of new market outlets and the development and dissemination of market intelligence. (41) The processing industry plays a role in the availability and quality of fishery and aquaculture products. It should be possible for the EMFAF to support targeted investments in that industry, provided that they contribute to the achievement of the objectives of the common organisation of the markets. For enterprises other than small and medium-sized enterprises (SMEs), such support should be provided only through financial instruments or through InvestEU and not through grants. (42) It should be possible for the EMFAF to support compensation to operators of the fishery and aquaculture sector in the case of exceptional events causing a significant disruption of markets. (43) Job creation in coastal regions relies on the locally driven development of a sustainable blue economy that revives the social fabric of those regions. Ocean industries and services are likely to outperform the growth of the global economy and make an important contribution to employment and growth by 2030. To be sustainable, blue growth depends on innovation and investment in new maritime businesses and in the bio-economy, including sustainable tourism models, ocean-based renewable energy, innovative high-end shipbuilding and new port services, which can create jobs and at the same time enhance local development. While public investment in the sustainable blue economy should be mainstreamed throughout the Union budget, the support from the EMFAF should specifically be focused on enabling conditions for the development of the sustainable blue economy and on removing bottlenecks to facilitate investment and the development of new markets, technologies or services. Support for the development of the sustainable blue economy should be delivered through shared, direct and indirect management. (44) The development of a sustainable blue economy strongly relies on partnerships between local stakeholders that contribute to the vitality of coastal and inland communities and economies. The EMFAF should provide tools to foster such partnerships. For that purpose, support through CLLD should be available under shared management. That approach should boost economic diversification in a local context through the development of coastal and inland fisheries, aquaculture and a sustainable blue economy. CLLD strategies should ensure that local communities in fishing and aquaculture areas better exploit and benefit from the opportunities offered by the sustainable blue economy, capitalising on and strengthening environmental, cultural, social and human resources. Every local partnership should therefore reflect the main focus of its strategy by ensuring a balanced involvement and representation of all relevant stakeholders from the local sustainable blue economy. (45) Under shared management, it should be possible for the EMFAF to support the strengthening of sustainable sea and ocean management through the collection, management and use of data to improve the knowledge on the state of the marine environment. That support should aim to fulfil requirements under Directives 92/43/EEC and 2009/147/EC, to support maritime spatial planning and to increase data quality and sharing through the European marine observation and data network. (46) Under direct and indirect management, support from the EMFAF should focus on the enabling conditions for a sustainable blue economy through the promotion of an integrated governance and management of the maritime policy, the enhancement of the transfer and uptake of research, innovation and technology in the sustainable blue economy, the improvement of maritime skills, ocean literacy and sharing of socio-economic data on the sustainable blue economy, the promotion of a low-carbon and climate-resilient sustainable blue economy, and the development of project pipelines and innovative financing instruments. Due consideration to the outermost regions\u2019 specific situation should be given in relation to the above-mentioned fields. (47) 60 % of the oceans are beyond the borders of national jurisdiction. This implies a shared international responsibility. Most problems facing the oceans, such as overexploitation, climate change, acidification, pollution and declining biodiversity, are transboundary in nature and therefore require a shared response. Under the United Nations Convention on the Law of the Sea, to which the Union is a Party under Council Decision 98/392/EC (18), many jurisdictional rights, institutions and specific frameworks have been set up to regulate and manage human activity in the oceans. In recent years, a global consensus has emerged that the marine environment and maritime human activities should be managed more effectively to address the increasing pressures on the oceans. (48) As a global actor, the Union is strongly committed to promoting international ocean governance, in accordance with the Joint Communication of the Commission and the High Representative of the Union for Foreign Affairs and Security Policy of 10 November 2016 entitled \u2018International ocean governance: an agenda for the future of our oceans\u2019. The Union\u2019s ocean governance policy covers the oceans in an integrated manner. International ocean governance is not only core to the achievement of the \u20182030 Agenda\u2019, and in particular SDG 14, but also to guarantee safe, secure, clean and sustainably managed seas and oceans for future generations. The Union needs to deliver on those international commitments and be a driving force for better international ocean governance at bilateral, regional and multilateral levels, including to prevent, deter and eliminate IUU fishing, to improve the international ocean governance framework, to reduce pressures on oceans and seas, to create the conditions for a sustainable blue economy and to strengthen international ocean research and data. (49) Actions promoting international ocean governance under the EMFAF are aimed to improve the overarching framework of international and regional processes, agreements, rules and institutions to regulate and manage human activity in the oceans. The EMFAF should support international arrangements that the Union has concluded in areas not covered by the SFPAs established with various third countries, as well as the Union\u2019s mandatory membership contribution to regional fisheries management organisations (RFMOs). SFPAs and RFMOs will continue to be funded under different strands of the Union budget. (50) With regard to security and defence, improved border protection and maritime security are essential. Under the European Union Maritime Security Strategy adopted by the Council of the European Union on 24 June 2014 and its Action Plan adopted on 16 December 2014, information sharing and the European border and coast guard cooperation between the European Fisheries Control Agency, the European Maritime Safety Agency and the European Border and Coast Guard Agency are key to deliver on those objectives. The EMFAF should therefore support maritime surveillance and coast guard cooperation under both shared and direct management, including by purchasing items for multipurpose maritime operations. It should also allow the relevant agencies to implement support in the field of maritime surveillance and security through indirect management. (51) Under shared management, each Member State should prepare a single programme that should be approved by the Commission. The Commission should assess the draft programmes by taking into account the maximisation of their contribution to the priorities of the EMFAF and to the objectives of resilience, green transition and digital transition. When assessing the draft programmes, the Commission should also take into account their contribution to the development of sustainable small-scale coastal fishing, to environmental, economic and social sustainability, to meeting the environmental and socio-economic challenges of the CFP, to the socio-economic performance of the sustainable blue economy, to the conservation and restoration of marine ecosystems, to the reduction of marine litter and to the mitigation of, and adaptation to, climate change. (52) In the context of regionalisation and with a view to encouraging Member States to have a strategic approach during the preparation of programmes, the Commission should assess the draft programmes by taking into account, where applicable, the regional sea basin analysis developed by the Commission indicating the common strengths and weaknesses with regard to the achievement of the objectives of the CFP. That analysis should guide both the Member States and the Commission in negotiating each programme, taking into account regional challenges and needs. (53) The performance of the EMFAF in Member States should be assessed on the basis of indicators. Member States should report on progress towards established milestones and targets in accordance with Regulation (EU) 2021/1060. A monitoring and evaluation framework should be established for that purpose. (54) For the purposes of providing information on the support from the EMFAF for environmental and climate objectives in accordance with Regulation (EU) 2021/1060, a methodology based on types of intervention should be established. That methodology should consist of assigning a specific weighting to the support provided at a level which reflects the extent to which such support makes a contribution to environmental objectives and to climate objectives. (55) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (19), the EMFAF should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators, as a basis for evaluating the effects of the EMFAF on the ground. (56) The Commission should implement information and communication actions relating to the EMFAF, and its actions and results. Financial resources allocated to the EMFAF should also contribute to the corporate communication of the political priorities of the Union, insofar as they are related to the priorities of the EMFAF. (57) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (20), Council Regulation (Euratom, EC) No 2988/95 (21), Council Regulation (Euratom, EC) No 2185/96 (22) and Council Regulation (EU) 2017/1939 (23), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor\u2019s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (24). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. Member States should prevent, detect and deal effectively with any irregularities, including fraud, committed by beneficiaries. Member States should report to the Commission any irregularities detected, including fraud, and any follow-up action they have taken with regard to such irregularities and with regard to any OLAF investigations. (58) In order to enhance transparency regarding the use of Union funds and their sound financial management, in particular reinforcing public control of the money used, certain information on the operations funded under the EMFAF should be published on a website of a Member State, in accordance with Regulation (EU) 2021/1060. When a Member State publishes information on operations funded under EMFAF, the rules on the protection of personal data set out in Regulation (EU) 2016/679 of the European Parliament and of the Council (25) are to be complied with. (59) In order to supplement certain non-essential elements of this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the identification of the threshold triggering, and the period of time of, inadmissibility with regard to the admissibility criteria of applications, in respect of the arrangements for recovering the aid granted in the event of serious infringements, in respect of the relevant starting or ending dates of the inadmissibility period and the conditions for a reduced period of inadmissibility and in respect of the definition of criteria for the calculation of the additional costs resulting from the specific handicaps of the outermost regions. In order to amend certain non-essential elements of this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should also be delegated to the Commission in order to allow for the introduction of additional core performance indicators. In order to facilitate a smooth transition from the scheme established by Regulation (EU) No 508/2014 to the scheme established by this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should also be delegated to the Commission in order to supplement this Regulation by establishing transitional provisions. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (60) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of the work programmes, the identification of energy-efficient technologies and the establishment of the methodological elements to measure CO2 emission reductions of fishing vessel engines, the occurrence of an exceptional event, the definition of the cases of non-compliance by Member States which can trigger an interruption of the payment deadline, the suspension of payments due to serious non-compliance by a Member State, financial corrections and the identification of relevant operation-level implementation data and their presentation. Except as regards the work programmes, including technical assistance, and the occurrence of an exceptional event, those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (26). (61) In accordance with Article 193(2) of the Financial Regulation, it should be possible for a grant to be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to Union\u2019s interests, it should be possible to provide in the financing decision, during a limited period of time at the beginning of the MFF 2021-2027, and only in duly justified cases, for eligibility of activities and costs from the beginning of the 2021 financial year, even if they were implemented and incurred before the grant application was submitted. For the same reasons and under the same conditions, it is necessary to derogate from Article 193(4) of the Financial Regulation as regards operating grants. (62) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (63) In order to ensure continuity in providing support in the relevant policy area and to allow implementation as of the beginning of the MFF 2021-2027, it is necessary to provide for the application of this Regulation, with retroactive effect, as regards the support under direct and indirect management from 1 January 2021. Consequently, this Regulation should enter into force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL FRAMEWORK CHAPTER I General provisions Article 1 Subject matter This Regulation establishes the European Maritime, Fisheries and Aquaculture Fund (the \u2018EMFAF\u2019) for the period from 1 January 2021 to 31 December 2027. The duration of the EMFAF is aligned with the duration of the MFF 2021-2027. It lays down the priorities of the EMFAF, its budget and the specific rules for providing Union funding, complementing the general rules applying to the EMFAF under Regulation (EU) 2021/1060. Article 2 Definitions 1. For the purposes of this Regulation and without prejudice to paragraph 2 of this Article, the definitions referred to in Article 4 of Regulation (EU) No 1380/2013, Article 5 of Regulation (EU) No 1379/2013, Article 4 of Regulation (EC) No 1224/2009, Article 2 of Regulation (EU) 2021/523 and Article 2 of Regulation (EU) 2021/1060 apply. 2. For the purposes of this Regulation, the following definitions apply: (1) \u2018Common Information Sharing Environment\u2019 or \u2018CISE\u2019 means an environment of systems developed to support the exchange of information between authorities involved in maritime surveillance, across sectors and borders, in order to improve their awareness of activities at sea; (2) \u2018coast guard\u2019 means national authorities performing coast guard functions, which encompass maritime safety, maritime security, maritime customs, prevention and suppression of trafficking and smuggling, connected maritime law enforcement, maritime border control, maritime surveillance, protection of the marine environment, search and rescue, accident and disaster response, fisheries control, inspection and other activities related to those functions; (3) \u2018European marine observation and data network\u2019 or \u2018EMODnet\u2019 means a partnership assembling marine data and metadata in order to make those fragmented resources more available and usable by public and private users by offering quality-assured, interoperable and harmonised marine data; (4) \u2018exploratory fishing\u2019 means any fishing operation carried out for commercial purposes in a given area, with a view to assessing the profitability and biological sustainability of regular, long-term exploitation of the fishery resources in that area for stocks that have not been subject to commercial fishing; (5) \u2018fisher\u2019 means any natural person engaging in commercial fishing activities, as recognised by the Member State concerned; (6) \u2018inland fishing\u2019 means fishing activities carried out for commercial purposes in inland waters by vessels or other devices, including those used for ice fishing; (7) \u2018international ocean governance\u2019 means a Union initiative to improve the overarching framework encompassing international and regional processes, agreements, arrangements, rules and institutions through a coherent cross-sectoral and rules-based approach, in order to ensure that oceans and seas are healthy, safe, secure, clean and sustainably managed; (8) \u2018landing site\u2019 means a location other than a maritime port as defined in point (16) of Article 2 of Regulation (EU) 2017/352 of the European Parliament and of the Council (27), which is officially recognised by a Member State, the use of which is not restricted to its owner and which is primarily used for landings of small-scale coastal fishing vessels; (9) \u2018maritime policy\u2019 means the Union policy that aims to foster integrated and coherent decision making to maximise the sustainable development, economic growth and social cohesion of the Union, particularly of the coastal and insular areas and of the outermost regions, and of the sustainable blue economy sectors, through coherent maritime-related policies and relevant international cooperation; (10) \u2018maritime security and surveillance\u2019 means activities carried out in order to understand, prevent wherever applicable and manage in a comprehensive way all the events and actions related to the maritime domain which would impact the areas of maritime safety and security, law enforcement, defence, border control, protection of the marine environment, fisheries control, trade and economic interest of the Union; (11) \u2018maritime spatial planning\u2019 means a process by which the relevant Member State\u2019s authorities analyse and organise human activities in marine areas to achieve ecological, economic and social objectives; (12) \u2018public body\u2019 means the State, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities or by one or more of such bodies, governed by public law; (13) \u2018sea basin strategy\u2019 means an integrated framework to address common marine and maritime challenges faced by Member States and, where appropriate, third countries, in a specific sea basin or in one or more sub-sea basins, and promote cooperation and coordination in order to achieve economic, social and territorial cohesion. It is developed by the Commission in cooperation with the Member States and third countries concerned, their regions and other stakeholders as appropriate; (14) \u2018small-scale coastal fishing\u2019 means fishing activities carried out by: (a) marine and inland fishing vessels of an overall length of less than 12 metres and not using towed gear as defined in point (1) of Article 2 of Council Regulation (EC) No 1967/2006 (28); or (b) fishers on foot, including shellfish gatherers; (15) \u2018sustainable blue economy\u2019 means all sectoral and cross-sectoral economic activities throughout the internal market relating to oceans, seas, coasts and inland waters, covering the Union\u2019s insular and outermost regions and landlocked countries, including emerging sectors and non-market goods and services, aimed at ensuring environmental, social and economic sustainability in the long term and which are consistent with the SDGs, and in particular SDG 14, and with Union environmental legislation. Article 3 Priorities The EMFAF shall contribute to the implementation of the CFP and of the Union\u2019s maritime policy. It shall pursue the following priorities: (1) fostering sustainable fisheries and the restoration and conservation of aquatic biological resources; (2) fostering sustainable aquaculture activities, and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union; (3) enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities; (4) strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed. Support under the EMFAF shall contribute to the achievement of the environmental and climate change mitigation and adaptation objectives of the Union. That contribution shall be tracked in accordance with the methodology set out in Annex IV. CHAPTER II Financial framework Article 4 Budget 1. The financial envelope for the implementation of the EMFAF for the period from 1 January 2021 to 31 December 2027 shall be EUR 6 108 000 000 in current prices. 2. The part of the financial envelope allocated to the EMFAF under Title II of this Regulation shall be implemented under shared management in accordance with Regulation (EU) 2021/1060 and Article 63 of the Financial Regulation. 3. The part of the financial envelope allocated to the EMFAF under Title III of this Regulation shall be implemented either directly by the Commission in accordance with point (a) of Article 62(1) of the Financial Regulation or within the framework of indirect management in accordance with point (c) of Article 62(1) of that Regulation. Article 5 Budgetary resources under shared management 1. The part of the financial envelope under shared management as specified in Title II shall be EUR 5 311 000 000 in current prices, in accordance with the annual breakdown set out in Annex V. 2. For operations located in the outermost regions, each Member State concerned shall allocate, within its Union financial support set out in Annex V, at least: (a) EUR 102 000 000 for the Azores and Madeira; (b) EUR 82 000 000 for the Canary Islands; (c) EUR 131 000 000 for Guadeloupe, French Guiana, Martinique, Mayotte, R\u00e9union and Saint-Martin. 3. The compensation referred to in Article 24 shall not exceed 60 % of each of the allocations referred to in points (a), (b) and (c) of paragraph 2 of this Article, or 70 % in circumstances justified in each action plan for the outermost regions. 4. At least 15 % of the Union financial support allocated per Member State shall be allocated in the programme, prepared and submitted in accordance with Article 21(1) and (2) of Regulation (EU) 2021/1060, to the specific objective referred to in point (d) of Article 14(1) of this Regulation. Member States with no access to Union waters may apply a lower percentage with regard to the extent of their control and data collection tasks. 5. The Union financial support from the EMFAF allocated per Member State to the total sum of the support referred to in Articles 17 to 21 shall not exceed the higher of the following thresholds: (a) EUR 6 000 000; or (b) 15 % of the Union financial support allocated per Member State. 6. In accordance with Articles 36 and 37 of Regulation (EU) 2021/1060, the EMFAF may support, at the initiative of a Member State, technical assistance for its effective administration and use. Article 6 Financial distribution for shared management The resources available for commitments by Member States referred to in Article 5(1) for the period from 2021 to 2027 are set out in Annex V. Article 7 Budgetary resources under direct and indirect management 1. The part of the financial envelope under direct and indirect management as specified in Title III shall be EUR 797 000 000 in current prices. 2. The amount referred to in paragraph 1 may be used for technical and administrative assistance for the implementation of the EMFAF, such as preparatory, monitoring, control, audit and evaluation activities, including corporate information technology systems. In particular, the EMFAF may support, at the initiative of the Commission and subject to the ceiling of 1,5 % of the financial envelope referred to in Article 4(1): (a) technical assistance for the implementation of this Regulation as referred to in Article 35 of Regulation (EU) 2021/1060; (b) the preparation, monitoring and evaluation of SFPAs and the Union participation in RFMOs; (c) the setting-up of a European-wide network of local action groups. 3. The EMFAF shall support the costs of information and communication activities linked to the implementation of this Regulation. CHAPTER III Programming Article 8 Programming for support under shared management 1. In accordance with Article 21 of Regulation (EU) 2021/1060, each Member State shall prepare a single programme to implement the priorities set out in Article 3 of this Regulation (the \u2018programme\u2019). In the preparation of the programme, the Member States shall endeavour to take into account regional and/or local challenges, as appropriate, and may identify intermediate bodies in accordance with Article 71(3) of Regulation (EU) 2021/1060. 2. Support under Title II of this Regulation in pursuit of the policy objectives set out in Article 5 of Regulation (EU) 2021/1060 shall be organised along the priorities and specific objectives as set out in Annex II to this Regulation. 3. In addition to the elements referred to in Article 22 of Regulation (EU) 2021/1060, the programme shall include: (a) an analysis of the situation in terms of strengths, weaknesses, opportunities and threats and the identification of the needs that require to be addressed in the relevant geographical area, including, where appropriate, sea basins relevant for the programme; (b) where applicable, the action plans for the outermost regions referred to in Article 35. 4. While carrying out the analysis of the situation in terms of the strengths, weaknesses, opportunities and threats referred to in point (a) of paragraph 3 of this Article, Member States shall take into account the specific needs of small-scale coastal fishing, as set out in Annex V to Regulation (EU) 2021/1060. For the specific objectives that contribute to the development of sustainable small-scale coastal fishing, Member States shall describe the types of actions considered for that purpose, as set out in point (i) of point (d) of Article 22(3) of, and Annex V to, Regulation (EU) 2021/1060. The managing authority shall endeavour to take into account the specificities of small-scale coastal fishing operators for possible simplification measures, such as simplified application forms. 5. The Commission shall assess the programme in accordance with Article 23 of Regulation (EU) 2021/1060. In its assessment it shall take into account, in particular: (a) the maximisation of the contribution of the programme to the priorities set out in Article 3 and to the objectives of resilience, green transition and digital transition, including through a wide range of innovative solutions; (b) the contribution of the programme to the development of sustainable small-scale coastal fishing; (c) the contribution of the programme to environmental, economic and social sustainability; (d) the balance between the fishing capacity of the fleets and the available fishing opportunities, as reported annually by Member States in accordance with Article 22(2) of Regulation (EU) No 1380/2013; (e) where applicable, the multiannual management plans adopted under Articles 9 and 10 of Regulation (EU) No 1380/2013, the management plans adopted under Article 19 of Regulation (EC) No 1967/2006 and the recommendations adopted by RFMOs that bind the Union; (f) the implementation of the landing obligation referred to in Article 15 of Regulation (EU) No 1380/2013; (g) the most recent evidence on the socio-economic performance of the sustainable blue economy, in particular in the fishery and aquaculture sector; (h) where applicable, the regional sea basin analyses developed by the Commission indicating the common strengths and weaknesses of each sea basin with regard to the achievement of the objectives of the CFP as set out in Article 2 of Regulation (EU) No 1380/2013; (i) the contribution of the programme to the conservation and restoration of marine ecosystems, while the support related to Natura 2000 areas shall be in accordance with the prioritised action frameworks established pursuant to Article 8(4) of Directive 92/43/EEC; (j) the contribution of the programme to the reduction of marine litter, in accordance with Directive (EU) 2019/904 of the European Parliament and of the Council (29); (k) the contribution of the programme to climate change mitigation and adaptation. Article 9 Programming for support under direct and indirect management In order to implement Title III, the Commission shall adopt implementing acts laying down work programmes. Work programmes shall set out, where applicable, the overall amount reserved for the blending operations referred to in Article 56. Except as regards technical assistance, those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). TITLE II SUPPORT UNDER SHARED MANAGEMENT CHAPTER I General principles of support Article 10 State aid 1. Without prejudice to paragraph 2 of this Article, Articles 107, 108 and 109 TFEU shall apply to aid granted by Member States to undertakings in the fishery and aquaculture sector. 2. However, Articles 107, 108 and 109 TFEU shall not apply to payments made by Member States pursuant to this Regulation and falling within the scope of Article 42 TFEU. 3. National provisions setting up public financing going beyond the provisions of this Regulation concerning payments referred to in paragraph 2 shall be treated as a whole on the basis of paragraph 1. 4. For the fishery and aquaculture products listed in Annex I TFEU to which Articles 107, 108 and 109 thereof apply, the Commission may authorise, in accordance with Article 108 TFEU, operating aid in the outermost regions referred to in Article 349 TFEU in respect of the sectors producing, processing and marketing fishery and aquaculture products, with a view to alleviating the specific constraints in those regions as a result of their isolation, insularity or remoteness. Article 11 Admissibility of applications 1. An application for support submitted by an operator shall be inadmissible for an identified period of time laid down pursuant to paragraph 4 of this Article, if it has been determined by the competent authority that the operator concerned: (a) has committed serious infringements under Article 42 of Council Regulation (EC) No 1005/2008 (30) or Article 90 of Regulation (EC) No 1224/2009 or under other legislation adopted by the European Parliament and the Council within the framework of the CFP; (b) has been involved in the operation, management or ownership of a fishing vessel included in the Union IUU vessel list as set out in Article 40(3) of Regulation (EC) No 1005/2008, or of a vessel flying the flag of countries identified as non-cooperating third countries as set out in Article 33 of that Regulation; or (c) has committed any of the environmental offences set out in Articles 3 and 4 of Directive 2008/99/EC of the European Parliament and of the Council (31), where the application for support is submitted under Article 27 of this Regulation. 2. If any of the situations referred to in paragraph 1 of this Article occurs throughout the period between submitting the application for support and five years after the final payment, the support paid from EMFAF and related to that application shall be recovered from the operator, in accordance with Article 44 of this Regulation and Article 103 of Regulation (EU) 2021/1060. 3. Without prejudice to more far-reaching national rules as agreed on in the Partnership Agreement with the Member State concerned, an application for support submitted by an operator shall be inadmissible for an identified period of time laid down pursuant to paragraph 4 of this Article, if it has been determined through a final decision by the competent authority concerned that the operator has committed fraud, as defined in Article 3 of Directive (EU) 2017/1371, in the context of the EMFF or the EMFAF. 4. The Commission is empowered to adopt delegated acts, in accordance with Article 62, supplementing this Regulation concerning: (a) the identification of the threshold triggering, and the period of time of, the inadmissibility referred to in paragraphs 1 and 3 of this Article, which shall be proportionate to the nature, gravity, duration and repetition of the serious infringements, offences or fraud committed, and shall be of at least one year\u2019s duration; (b) in accordance with Article 44 of this Regulation and Article 103 of Regulation (EU) 2021/1060, the arrangements for recovering the support granted pursuant to paragraph 2 of this Article, which shall be proportionate to the nature, gravity, duration and repetition of the serious infringements or offences committed; (c) the relevant starting or ending dates of the periods of time referred to in paragraphs 1 and 3 and the conditions for a reduced period of inadmissibility. 5. Member States may apply, in accordance with national rules, a longer inadmissibility period than that laid down pursuant to paragraph 4. Member States may apply an inadmissibility period also to applications for support submitted by operators engaged in inland fishing who have committed serious infringements, as defined by national rules. 6. Member States shall require that operators submitting an application for support under the EMFAF provide to the managing authority a signed statement confirming that they do not fall under any of the situations listed in paragraphs 1 and 3 of this Article. Member States shall verify the veracity of that statement before approving the application, based on the information available in the national registers of infringements referred to in Article 93 of Regulation (EC) No 1224/2009, or any other available data. For the purposes of the verification referred to in the first subparagraph of this paragraph, a Member State shall provide, on request from another Member State, the information contained in its national register of infringements referred to in Article 93 of Regulation (EC) No 1224/2009. Article 12 Eligibility for support from the EMFAF under shared management 1. Without prejudice to the rules on eligibility of expenditure laid down in Regulation (EU) 2021/1060, Member States may select for support under this Title the operations which: (a) fall under the scope of the priorities and specific objectives set out in Article 8(2); (b) are not ineligible pursuant to Article 13; and (c) are in accordance with applicable Union law. 2. The EMFAF may support investments on board necessary to comply with requirements imposed by a Member State to give effect to optional provisions under Directive (EU) 2017/159. Article 13 Ineligible operations or expenditure The following operations or expenditure shall not be eligible for support from the EMFAF: (a) operations that increase the fishing capacity of a fishing vessel, unless otherwise provided for in Article 19; (b) the acquisition of equipment that increases the ability of a fishing vessel to find fish; (c) the construction, acquisition or importation of fishing vessels, unless otherwise provided for in Article 17; (d) the transfer or reflagging of fishing vessels to third countries, including through the creation of joint ventures with partners of third countries; (e) the temporary or permanent cessation of fishing activities, unless otherwise provided for in Articles 20 and 21; (f) exploratory fishing; (g) the transfer of ownership of a business; (h) direct restocking, except explicitly provided for as a reintroduction measure or other conservation measures in a Union legal act or in the case of experimental restocking; (i) the construction of new ports or new auction halls, with the exception of new landing sites; (j) market intervention mechanisms aiming to temporarily or permanently withdraw fishery or aquaculture products from the market with a view to reducing supply in order to prevent price decline or to drive prices up, unless otherwise provided for in Article 26(2); (k) investments on board fishing vessels necessary to comply with the requirements under Union law in force at the time of submission of the application for support, including requirements under the Union\u2019s obligations in the context of RFMOs, unless otherwise provided for in Article 22; (l) investments on board fishing vessels that have carried out fishing activities for less than 60 days in the two calendar years preceding the year of submission of the application for support; (m) the replacement or modernisation of a main or ancillary engine of a fishing vessel, unless otherwise provided for in Article 18. CHAPTER II Priority 1: Fostering sustainable fisheries and the restoration and conservation of aquatic biological resources Section 1 Scope of support Article 14 Specific objectives 1. Support under this Chapter shall cover interventions that contribute to the achievement of the objectives of the CFP as set out in Article 2 of Regulation (EU) No 1380/2013, through one or more of the following specific objectives: (a) strengthening economically, socially and environmentally sustainable fishing activities; (b) increasing energy efficiency and reducing CO2 emissions through the replacement or modernisation of engines of fishing vessels; (c) promoting the adjustment of fishing capacity to fishing opportunities in cases of permanent cessation of fishing activities and contributing to a fair standard of living in cases of temporary cessation of fishing activities; (d) fostering efficient fisheries control and enforcement, including fighting against IUU fishing, as well as reliable data for knowledge-based decision making; (e) promoting a level-playing field for fishery and aquaculture products from the outermost regions; and (f) contributing to the protection and restoration of aquatic biodiversity and ecosystems. 2. Support under this Chapter may be granted to inland fishing under the conditions provided for in Article 16. Section 2 Specific conditions Article 15 Transferring or reflagging of fishing vessels Where support under this Chapter is granted in respect of a Union fishing vessel, that vessel shall not be transferred or reflagged outside the Union during at least five years from the final payment for the supported operation. Article 16 Inland fishing 1. The provisions laid down in point (a) of Article 17(6), point (a) of Article 18(2), points (a) and (d) of Article 19(2), Article 20, points (a) to (d) of Article 21(2), as well as the reference to Regulation (EC) No 1224/2009 in point (d) of Article 19(3) of this Regulation, shall not apply to inland fishing vessels. 2. In the case of inland fishing vessels, the references to the date of registration in the Union fleet register in points (d) and (e) of Article 17(6), point (b) of Article 18(2) and point (c) of Article 19(2) shall be replaced by references to the date of entry into service, in accordance with national law. Article 17 First acquisition of a fishing vessel 1. By way of derogation from point (c) of Article 13, the EMFAF may support the first acquisition of a fishing vessel or the acquisition of partial ownership thereof. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (a) of Article 14(1). 2. Support under this Article may only be granted to a natural person who: (a) is no more than 40 years of age at the date of submission of the application for support; and (b) has worked at least five years as fisher or has acquired adequate qualification. 3. Support under paragraph 1 may also be granted to legal entities wholly owned by one or more natural persons who each fulfil the conditions set out in paragraph 2. 4. Support under this Article may be granted for the joint first acquisition of a fishing vessel by several natural persons who each fulfil the conditions set out in paragraph 2. 5. Support under this Article may also be granted for the acquisition of partial ownership of a fishing vessel by a natural person who fulfils the conditions set out in paragraph 2 and who shall be deemed to have controlling rights on that vessel through ownership of at least of 33 % of the vessel or of the shares in the vessel or by a legal entity which fulfils the conditions set out in paragraph 3 and which shall be deemed to have controlling rights on that vessel through ownership of at least of 33 % of the vessel or of the shares in the vessel. 6. Support under this Article may be granted only in respect of a fishing vessel which: (a) belongs to a fleet segment for which the latest report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown a balance with the fishing opportunities available to that segment; (b) is equipped for fishing activities; (c) is not longer than 24 metres in overall length; (d) has been registered in the Union fleet register for at least three calendar years preceding the year of submission of the application for support in the case of a small-scale coastal fishing vessel, and for at least five calendar years in the case of another type of vessel; and (e) has been registered in the Union fleet register for a maximum of 30 calendar years preceding the year of submission of the application for support. 7. The first acquisition of a fishing vessel supported under this Article shall not be considered a transfer of ownership of a business within the meaning of point (g) of Article 13. Article 18 Replacement or modernisation of a main or ancillary engine 1. By way of derogation from point (m) of Article 13, the EMFAF may support the replacement or modernisation of a main or ancillary engine of a fishing vessel up to 24 metres in overall length. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (b) of Article 14(1). 2. Support under this Article may be granted only under the following conditions: (a) the vessel belongs to a fleet segment for which the latest report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown a balance with the fishing opportunities available to that segment; (b) the vessel has been registered in the Union fleet register for at least five calendar years preceding the year of submission of the application for support; (c) for small-scale coastal fishing vessels, the new or modernised engine does not have more power in kW than that of the current engine; and (d) for other vessels up to 24 metres in overall length, the new or modernised engine does not have more power in kW than that of the current engine and emits at least 20 % less CO2 compared to the current engine. 3. Member States shall ensure that all replaced or modernised engines are subject to a physical verification. 4. The fishing capacity withdrawn due to the replacement or modernisation of a main or ancillary engine shall not be replaced. 5. The reduction of CO2 emission required under point (d) of paragraph 2 shall be considered to be met in either of the following cases: (a) where relevant information certified by the manufacturer of the engine concerned as part of a type approval or product certificate indicates that the new engine emits 20 % less CO2 than the engine being replaced; or (b) where relevant information certified by the manufacturer of the engine concerned as part of a type approval or product certificate indicates that the new engine uses 20 % less fuel than the engine being replaced. Where the relevant information certified by the manufacturer of the engine concerned as part of a type approval or product certificate for one or both of the engines does not permit a comparison of the CO2 emission or fuel consumption, the reduction of CO2 emission required under point (d) of paragraph 2 shall be considered to be met in any of the following cases: (a) the new engine uses an energy-efficient technology and the age difference between the new engine and the engine being replaced is at least seven years; (b) the new engine uses a type of fuel or a propulsion system which is considered to emit less CO2 than the engine being replaced; (c) the Member State measures that the new engine emits 20 % less CO2 or uses 20 % less fuel than the engine being replaced under the normal fishing effort of the vessel concerned. The Commission shall adopt implementing acts to identify the energy-efficient technologies referred to in point (a) of the second subparagraph of this paragraph and to further specify the methodology elements for the implementation of point (c) of that subparagraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). Article 19 Increase in the gross tonnage of a fishing vessel to improve safety, working conditions or energy efficiency 1. By way of derogation from point (a) of Article 13, the EMFAF may support operations that increase the gross tonnage of a fishing vessel for the purposes of improving safety, working conditions or energy efficiency. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (a) of Article 14(1). 2. Support under this Article may be granted only under the following conditions: (a) the fishing vessel belongs to a fleet segment for which the latest report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown a balance of the fishing capacity of the segment with the fishing opportunities available to that segment; (b) the fishing vessel is not longer than 24 metres in overall length; (c) the fishing vessel has been registered in the Union fleet register for at least the 10 calendar years preceding the year of submission of the application for support; and (d) the entry into the fishing fleet of new fishing capacity generated by the operation is compensated for by the prior withdrawal of at least the same amount of fishing capacity without public aid from the same fleet segment or from a fleet segment for which the latest report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown that the fishing capacity is not in balance with the fishing opportunities available to that segment. 3. For the purposes of paragraph 1, only the following operations shall be eligible: (a) the increase in gross tonnage necessary for the subsequent installation or renovation of accommodation facilities dedicated to the exclusive use of the crew, including sanitary facilities, common areas, kitchen facilities and shelter deck structures; (b) the increase in gross tonnage necessary for the subsequent improvement or installation of on-board fire prevention systems, safety and alarm systems or noise-reduction systems; (c) the increase in gross tonnage necessary for the subsequent installation of integrated bridge systems to improve navigation or engine control; (d) the increase in gross tonnage necessary for the subsequent installation or renovation of an engine or a propulsion system that demonstrates a better energy efficiency or lower CO2 emissions compared to the previous situation, which does not have a power exceeding the fishing vessel\u2019s previously certified engine power pursuant to Article 40(1) of Regulation (EC) No 1224/2009, and whose maximum power output is certified by the manufacturer for that engine or propulsion system model; (e) the replacement or renovation of the bulbous bow provided that it improves the overall energy efficiency of the fishing vessel. 4. As part of the data provided pursuant to Article 46(3), Member States shall communicate to the Commission the characteristics of the operations supported under this Article, including the amount of the fishing capacity increased and the purpose of that increase. 5. Support under this Article shall not cover operations related to investments aimed at improving safety, working conditions or energy efficiency where such operations do not increase the fishing capacity of the vessel concerned. Those operations may be supported in accordance with Article 12. Article 20 Permanent cessation of fishing activities 1. By way of derogation from point (e) of Article 13, the EMFAF may support compensation for the permanent cessation of fishing activities. The support referred to in the first subparagraph of this paragraph shall contribute to the specific objective referred to in point (c) of Article 14(1). 2. Support under this Article may be granted only under the following conditions: (a) the cessation is foreseen as a tool of an action plan referred to in Article 22(4) of Regulation (EU) No 1380/2013; (b) the cessation is achieved through the scrapping of the fishing vessel or through its decommissioning and retrofitting for activities other than commercial fishing, keeping in line with the objectives of the CFP and of the multiannual plans referred to in Regulation (EU) No 1380/2013; (c) the fishing vessel is registered as active and has carried out fishing activities at sea for at least 90 days per year during the last two calendar years preceding the date of submission of the application for support; (d) the equivalent fishing capacity is permanently removed from the Union fishing fleet register and the fishing licences and the fishing authorisations are permanently withdrawn, in accordance with Article 22(5) and (6) of Regulation (EU) No 1380/2013; and (e) the beneficiary shall not register any fishing vessel within five years following the receipt of support. 3. The support referred to in paragraph 1 may only be granted to: (a) owners of Union fishing vessels concerned by the permanent cessation; and (b) fishers who have worked at sea on board a Union fishing vessel concerned by the permanent cessation for at least 90 days per year during the last two calendar years preceding the year of submission of the application for support. The fishers referred to in point (b) of the first subparagraph shall cease all fishing activities for five years following the receipt of support. If a fisher returns to fishing activities within that period of time, sums unduly paid in respect of the operation shall be recovered by the Member State concerned, in an amount proportionate to the period during which the condition set out in the first sentence of this subparagraph has not been fulfilled. Article 21 Temporary cessation of fishing activities 1. By way of derogation from point (e) of Article 13, the EMFAF may support compensation for the temporary cessation of fishing activities. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (c) of Article 14(1). 2. Support under this Article may be granted only in the case of: (a) conservation measures, as referred to in points (a), (b), (c), (i) and (j) of Article 7(1) of Regulation (EU) No 1380/2013 or, where applicable to the Union, equivalent conservation measures adopted by RFMOs; (b) Commission measures in case of a serious threat to marine biological resources, as referred to in Article 12 of Regulation (EU) No 1380/2013; (c) Member States\u2019 emergency measures pursuant to Article 13 of Regulation (EU) No 1380/2013; (d) the interruption, due to reasons of force majeure, of the application of a SFPA or protocol thereto; or (e) natural disasters, environmental incidents or health crises, as formally recognised by the competent authorities of the relevant Member State. 3. The support referred to in paragraph 1 may only be granted where the fishing activities of the vessel or fisher concerned are stopped during at least 30 days in a given calendar year. 4. The support referred to in point (a) of paragraph 2 may only be granted where, based on scientific advice, a reduction of fishing effort is needed in order to achieve the objectives referred to in Article 2(2) and point (a) of Article 2(5) of Regulation (EU) No 1380/2013. 5. The support referred to in paragraph 1 may only be granted to: (a) owners or operators of Union fishing vessels which are registered as active and which have carried out fishing activities at sea for at least 120 days during the last two calendar years preceding the year of submission of the application for support; (b) fishers who have worked at sea on board a Union fishing vessel concerned by the temporary cessation for at least 120 days during the last two calendar years preceding the year of submission of the application for support; or (c) fishers on foot who have carried out fishing activities for at least 120 days during the last two calendar years preceding the year of submission of the application for support. The reference to the number of days at sea in this paragraph shall not apply to eel fisheries. 6. The support referred to in paragraph 1 may be granted for a maximum duration of 12 months per vessel or per fisher during the programming period. 7. All fishing activities carried out by the vessels or fishers concerned shall be effectively suspended during the period concerned by the temporary cessation. The Member State concerned shall satisfy itself that the vessel or fisher concerned has ceased any fishing activities during the period concerned by the temporary cessation and that any overcompensation resulting from the use of the vessel for other purposes is avoided. Article 22 Control and enforcement 1. The EMFAF may support the development and implementation of a Union fisheries control system as provided for in Article 36 of Regulation (EU) No 1380/2013 and further specified in Regulations (EC) No 1224/2009 and (EC) No 1005/2008. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (d) of Article 14(1). 2. By way of derogation from point (k) of Article 13, the support referred to in paragraph 1 of this Article may cover: (a) the purchase, installation and management on board of the necessary components for compulsory vessel tracking and electronic reporting systems used for control purposes; (b) the purchase, installation and management on board of the necessary components for compulsory remote electronic monitoring systems used for controlling the implementation of the landing obligation referred to in Article 15 of Regulation (EU) No 1380/2013; (c) the purchase, installation and management on board of devices for compulsory continuous measurement and recording of propulsive engine power. 3. The support referred to in paragraph 1 of this Article may also contribute to maritime surveillance as referred to in Article 33 and to the cooperation on coast guard functions as referred to in Article 34. Article 23 Collection, management, use and processing of data in the fisheries sector, and research and innovation programmes 1. The EMFAF may support the collection, management, use and processing of biological, environmental, technical and socio-economic data in the fisheries sector, as provided for in Article 25(1) and (2) of Regulation (EU) No 1380/2013 and further specified in Regulation (EU) 2017/1004, on the basis of the national work plans referred to in Article 6 of Regulation (EU) 2017/1004. The EMFAF may also support fisheries and aquaculture research and innovation programmes, as provided for in Article 27 of Regulation (EU) No 1380/2013. 2. The support referred to in paragraph 1 of this Article shall contribute to the specific objective referred to in point (d) of Article 14(1). Article 24 Promoting a level-playing field for fishery and aquaculture products from the outermost regions 1. The EMFAF may support compensation for additional costs incurred by operators in the fishing, farming, processing and marketing of certain fishery and aquaculture products from the outermost regions. 2. The support referred to in paragraph 1 of this Article shall contribute to the specific objective referred to in point (e) of Article 14(1). 3. Support under this Article may be granted only under the conditions set out in Article 36. Article 25 Protection and restoration of aquatic biodiversity and ecosystems 1. The EMFAF may support actions that contribute to the protection and restoration of aquatic biodiversity and ecosystems, including in inland waters. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (f) of Article 14(1). 2. The support referred to in paragraph 1 may include, inter alia: (a) compensation to fishers for the passive collection of lost fishing gear and marine litter from the sea; (b) investments in ports or other infrastructure to provide adequate reception facilities for lost fishing gear and marine litter collected from the sea; (c) actions to achieve or maintain a good environmental status in the marine environment, as set out in Article 1(1) of Directive 2008/56/EC; (d) the implementation of spatial protection measures established pursuant to Article 13(4) of Directive 2008/56/EC; (e) the management, restoration, surveillance and monitoring of Natura 2000 areas, taking into account the prioritised action frameworks established pursuant to Article 8 of Directive 92/43/EEC; (f) the protection of species under Directives 92/43/EEC and 2009/147/EC, taking into account the prioritised action frameworks established pursuant to Article 8 of Directive 92/43/EEC; (g) the restoration of inland waters in accordance with the programme of measures established pursuant to Article 11 of Directive 2000/60/EC. CHAPTER III Priority 2: Fostering sustainable aquaculture activities and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union Section 1 Scope of support Article 26 Specific objectives 1. Support under this Chapter shall cover interventions that contribute to the achievement of the objectives of the CFP as set out in Article 2 of Regulation (EU) No 1380/2013, through the following specific objectives: (a) promoting sustainable aquaculture activities, especially strengthening the competitiveness of aquaculture production, while ensuring that the activities are environmentally sustainable in the long term; (b) promoting marketing, quality and added value of fishery and aquaculture products, as well as processing of those products. 2. By way of derogation from point (j) of Article 13, in case of exceptional events causing a significant disruption of markets, the support referred to in point (b) of paragraph 1 of this Article may cover: (a) compensation to operators of the fishery and aquaculture sector for their income foregone or additional costs; and (b) compensation to recognised producer organisations and associations of producer organisations which store fishery products listed in Annex II to Regulation (EU) No 1379/2013, provided that those products are stored in accordance with Articles 30 and 31 of that Regulation. The support referred to in the first subparagraph may be eligible only if the Commission has established, by means of an implementing decision, the occurrence of an exceptional event. Expenditure shall be eligible only during the duration set out in that implementing decision. 3. In addition to the activities referred to in point (a) of paragraph 1 of this Article within the scope of Article 2 of Regulation (EU) No 1380/2013, support under that point may also cover interventions that contribute to aquaculture providing environmental services, as well as to ensuring animal health and welfare in aquaculture within the scope of Regulation (EU) 2016/429 of the European Parliament and of the Council (32). 4. Support under point (b) of paragraph 1 of this Article may also contribute to the achievement of the objectives of common organisation of the markets in fishery and aquaculture products as provided for in Article 35 of Regulation (EU) No 1380/2013, including the production and marketing plans as described in Article 28 of Regulation (EU) No 1379/2013. Section 2 Specific conditions Article 27 Aquaculture To achieve the specific objective referred to in point (a) of Article 26(1) of this Regulation as regards the promotion of aquaculture activities, support shall be consistent with the multiannual national strategic plans for the development of aquaculture referred to in Article 34(2) of Regulation (EU) No 1380/2013. Article 28 Processing of fishery and aquaculture products To achieve the specific objective referred to in point (b) of Article 26(1) of this Regulation as regards the processing of fishery and aquaculture products, support to enterprises other than SMEs shall only be granted through the financial instruments provided for in Article 58 of Regulation (EU) 2021/1060 or through InvestEU, in accordance with Article 10 of Regulation (EU) 2021/523. CHAPTER IV Priority 3: Enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities Section 1 Scope of support Article 29 Specific objective Support under this Chapter shall cover interventions that contribute to enabling a sustainable blue economy in coastal, island and inland areas, and to fostering the sustainable development of fishing and aquaculture communities. Section 2 Specific conditions Article 30 Community-led local development 1. To achieve the specific objective referred to in Article 29 of this Regulation, support shall be implemented through the CLLD set out in Article 31 of Regulation (EU) 2021/1060. 2. For the purposes of this Article, the CLLD strategies referred to in Article 32 of Regulation (EU) 2021/1060 shall ensure that communities in fishing or aquaculture areas better exploit and benefit from the opportunities offered by the sustainable blue economy, capitalising on and strengthening environmental, cultural, social and human resources. Those CLLD strategies may range from those which focus on fisheries or aquaculture to broader strategies directed at the diversification of local communities. CHAPTER V Priority 4: Strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed Section 1 Scope of support Article 31 Specific objective Support under this Chapter shall cover interventions that contribute to strengthening sustainable sea and ocean management through the promotion of marine knowledge, maritime surveillance or coast guard cooperation. Section 2 Specific conditions Article 32 Marine knowledge Support granted to achieve the specific objective referred to in Article 31 of this Regulation through the promotion of marine knowledge shall contribute to actions aiming to collect, manage, analyse, process and use data to improve the knowledge on the state of the marine environment, with a view to: (a) fulfilling monitoring and site designation and management requirements under Directives 92/43/EEC and 2009/147/EC; (b) supporting maritime spatial planning under Directive 2014/89/EU of the European Parliament and of the Council (33); or (c) increasing data quality and sharing through the European marine observation and data network (EMODnet). Article 33 Maritime surveillance 1. To achieve the specific objective set out in Article 31 through the promotion of maritime surveillance, support shall be granted for actions contributing to the achievement of the objectives of the CISE. 2. The support for actions referred to in paragraph 1 of this Article may also contribute to the development and implementation of a Union fisheries control system under the conditions set out in Article 22. Article 34 Coast guard cooperation 1. Support granted to achieve the specific objective set out in Article 31 through the promotion of coast guard cooperation shall contribute to actions carried out by national authorities in the framework of the European cooperation on coast guard functions referred to in Article 69 of Regulation (EU) 2019/1896 of the European Parliament and of the Council (34), Article 2b of Regulation (EC) No 1406/2002 of the European Parliament and of the Council (35) and Article 8 of Regulation (EU) 2019/473 of the European Parliament and of the Council (36). 2. The support for actions referred to in paragraph 1 of this Article may also contribute to the development and implementation of a Union fisheries control system under the conditions set out in Article 22. CHAPTER VI Sustainable development of the outermost regions Article 35 Action plan for the outermost regions In accordance with Article 8(3), Member States concerned shall prepare, as part of their programme, an action plan for each of their outermost regions, which shall set out: (a) a strategy for the sustainable exploitation of fisheries and the development of sustainable blue economy sectors; (b) a description of the main actions envisaged and the corresponding financial means, including: (i) the structural support to the fishery and aquaculture sector under this Title; (ii) compensation for additional costs referred to in Articles 24 and 36, including the methodology for its calculation; (iii) any other investment in the sustainable blue economy necessary to achieve a sustainable coastal development. Article 36 Compensation for additional costs for fishery and aquaculture products 1. To implement the compensation for additional costs incurred by operators in the fishing, farming, processing and marketing of certain fishery and aquaculture products from the outermost regions, as referred to in Article 24, each Member State concerned shall determine, in line with the criteria laid down in accordance with paragraph 6 of this Article, for each outermost region, the list of fishery and aquaculture products and the quantity of those products eligible for compensation. 2. When establishing the lists and the quantities referred to in paragraph 1, Member States shall take into account all relevant factors, in particular the need to ensure that the compensation is compatible with the rules of the CFP. 3. The compensation shall not be granted for fishery and aquaculture products: (a) caught by third country vessels, with the exception of fishing vessels which fly the flag of Venezuela and operate in Union waters, in accordance with Council Decision (EU) 2015/1565 (37); (b) caught by Union fishing vessels that are not registered in a port of one of the outermost regions; (c) imported from third countries. 4. Point (b) of paragraph 3 shall not apply if the existing capacity of the processing industry in the outermost region concerned exceeds the quantity of raw material supplied. 5. The compensation paid to the beneficiaries carrying out the activities referred to in paragraph 1 in the outermost regions or owning a vessel registered in a port of one of those regions and operating there shall, in order to avoid overcompensation, take into account: (a) for each fishery or aquaculture product or category of products, the additional costs resulting from the specific handicaps of the regions concerned; and (b) any other type of public intervention affecting the level of additional costs. 6. The Commission is empowered to adopt delegated acts, in accordance with Article 62, supplementing this Regulation by laying down the criteria for the calculation of the additional costs resulting from the specific handicaps of the regions concerned. Article 37 State aid for implementation of compensation for additional costs Member States may grant additional financing for the implementation of the compensation referred to in Article 24. In such cases, Member States shall notify the Commission of the State aid, which the Commission may approve in accordance with this Regulation as part of that compensation. State aid thus notified shall be regarded as notified within the meaning of the first sentence of Article 108(3) TFEU. Article 38 Evaluation When carrying out the mid-term evaluation referred to in Article 45 of Regulation (EU) 2021/1060, the Commission shall specifically examine the provisions of this Chapter, including those related to compensation of additional costs. CHAPTER VII Rules for implementation under shared management Section 1 Support from the EMFAF Article 39 Calculation of compensation Compensation for additional costs or income foregone and other compensation provided under this Regulation shall be granted under any of the forms referred to in points (b) to (e) of Article 53(1) of Regulation (EU) 2021/1060. Article 40 Determination of co-financing rates The maximum EMFAF co-financing rate per specific objective shall be 70 % of the eligible public expenditure, with the exception of the specific objective referred to in point (e) of Article 14(1), for which it shall be 100 %. Article 41 Intensity of public aid 1. Member States shall apply a maximum aid intensity rate of 50 % of the total eligible expenditure of the operation. 2. By way of derogation from paragraph 1, specific maximum aid intensity rates are set out in Annex III. 3. Where one operation falls under several of the rows 2 to 19 of Annex III, the highest maximum aid intensity rate shall apply. 4. Where one operation falls under one or several of the rows 2 to 19 of Annex III and at the same time under row 1 of that Annex, the maximum aid intensity rate referred to in row 1 shall apply. Section 2 Financial management Article 42 Interruption of the payment deadline 1. In accordance with Article 96(4) of Regulation (EU) 2021/1060, the Commission may interrupt the payment deadline for all or part of a payment application in the case of non-compliance by a Member State with the rules applicable under the CFP, if the non-compliance is liable to affect the expenditure contained in a payment application for which the interim payment is requested. 2. Prior to the interruption referred to in paragraph 1, the Commission shall inform the Member State concerned about the non-compliance and give it the opportunity to present observations within a reasonable period of time. 3. The interruption referred to in paragraph 1 shall be proportionate to the nature, gravity, duration and repetition of the non-compliance. 4. The Commission may adopt implementing acts to define the cases of non-compliance referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). Article 43 Suspension of payments 1. In accordance with Article 97(3) of Regulation (EU) 2021/1060, the Commission may adopt implementing acts suspending all or part of the interim payments under the programme in the case of serious non-compliance by a Member State with the rules applicable under the CFP, if the serious non-compliance is liable to affect the expenditure contained in a payment application for which the interim payment is requested. 2. Prior to the suspension referred to in paragraph 1, the Commission shall inform the Member State concerned that the Commission considers that there is a case of serious non-compliance by that Member State with the rules applicable under the CFP and give it opportunity to present observations within a reasonable period of time. 3. The suspension referred to in paragraph 1 shall be proportionate to the nature, gravity, duration and repetition of the serious non-compliance. 4. The Commission may adopt implementing acts to define the cases of serious non-compliance referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). Article 44 Financial corrections by Member States In the cases of the financial corrections referred to in Article 11(2),, Member States shall determine the amount of the correction, which shall be proportionate to the nature, gravity, duration and repetition of the serious infringements or offences by the beneficiary concerned and the importance of the EMFAF contribution to the economic activity of that beneficiary. Article 45 Financial corrections by the Commission 1. In accordance with Article 104(5) of Regulation (EU) 2021/1060, the Commission may adopt implementing acts making financial corrections by cancelling all or part of the Union contribution to the programme if, after carrying out the necessary examination, it concludes that: (a) expenditure contained in a payment application is affected by cases where any of the situations referred to in Article 11(2) of this Regulation has occurred and has not been corrected by the Member State concerned prior to the opening of the correction procedure under this paragraph; (b) expenditure contained in a payment application is affected by cases of serious non-compliance with the rules of the CFP by the Member State which have resulted in the suspension of payment under Article 43 of this Regulation and the Member State concerned still fails to demonstrate that it has taken the necessary remedial action to ensure compliance with, and the enforcement of, applicable rules of the CFP in the future. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2) of this Regulation. 2. The Commission shall decide on the amount of the correction taking into account the nature, gravity, duration and repetition of the serious non-compliance with the rules of the CFP by the Member State or beneficiary concerned and the importance of the EMFAF contribution to the economic activity of the beneficiary concerned. 3. Where it is not possible to quantify precisely the amount of expenditure linked to serious non-compliance with the rules of the CFP by the Member State, the Commission shall apply a flat rate or extrapolated financial correction in accordance with paragraph 4. 4. The Commission may adopt implementing acts to determine the criteria for establishing the level of financial correction to be applied and the criteria for applying flat rates or extrapolated financial corrections. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). Section 3 Monitoring and reporting Article 46 Monitoring and evaluation framework 1. Common output and result indicators for the EMFAF, as set out in Annex I to this Regulation, and, where necessary, programme-specific indicators, shall be used in accordance with point (a) of the second subparagraph of Article 16(1), point (d)(ii) of Article 22(3) and point (b) of Article 42(2) of Regulation (EU) 2021/1060. 2. In compliance with its reporting requirement pursuant to paragraph (iii) of point (h) of Article 41(3) of the Financial Regulation, the Commission shall report to the European Parliament and the Council on the performance of the EMFAF. In that report, the Commission shall use the core performance indicators set out in Annex I to this Regulation. 3. In addition to the general rules set out in Article 42 of Regulation (EU) 2021/1060, the managing authority shall provide the Commission with relevant operation-level implementation data, which shall include key characteristics of the beneficiary (name, type of beneficiary, size of enterprise, gender and contact details) and of the operation supported (specific objective, type of operation, sector concerned, values of indicators, state of progress of the operation, common fleet register number, financial data and form of support). The data shall be provided by 31 January and 31 July of each year. The first transmission of those data shall be due by 31 January 2022 and the last one by 31 January 2030. 4. The Commission shall adopt implementing acts laying down rules further specifying the exact data referred to in paragraph 3 of this Article and its presentation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). 5. The Commission is empowered to adopt delegated acts, in accordance with Article 62, to amend Annex I by adding the core performance indicators in order to adapt to changes occurring during the programming period. Article 47 Reporting of the results of the funded operation 1. The beneficiaries shall report the value of relevant result indicators after the completion of the operation and no later than the final payment application. The managing authority shall review the plausibility of the value of result indicators reported by the beneficiary in parallel with the final payment. 2. Member States may postpone the timelines established in paragraph 1. TITLE III SUPPORT UNDER DIRECT AND INDIRECT MANAGEMENT CHAPTER I Priority 1: Fostering sustainable fisheries and the restoration and conservation of aquatic biological resources Article 48 Implementation of the CFP The EMFAF shall support the implementation of the CFP through: (a) the provision of scientific advice and knowledge for the purposes of promoting sound and efficient fisheries management decisions under the CFP, including through the participation of experts in scientific bodies; (b) regional cooperation on conservation measures as referred to in Article 18 of Regulation (EU) No 1380/2013, in particular in the context of the multiannual plans referred to in Articles 9 and 10 thereof; (c) the development and implementation of a Union fisheries control system as provided for in Article 36 of Regulation (EU) No 1380/2013 and further specified in Regulation (EC) No 1224/2009; (d) the functioning of Advisory Councils established in accordance with Article 43 of Regulation (EU) No 1380/2013, an objective of which is forming part of, and supporting, the CFP; (e) voluntary contributions to the activities of international organisations dealing with fisheries, in accordance with Articles 29 and 30 of Regulation (EU) No 1380/2013. Article 49 Promotion of clean and healthy seas and oceans 1. The EMFAF shall support the promotion of clean and healthy seas and oceans, including through actions to support the implementation of Directive 2008/56/EC and actions to ensure coherence with the objective of achieving a good environmental status as set out in point (j) of Article 2(5) of Regulation (EU) No 1380/2013, and the implementation of the European strategy for plastics in a circular economy. 2. The support referred to in paragraph 1 of this Article shall be in line with the Union environmental legislation, in particular with the objective of achieving or maintaining a good environmental status as set out in Article 1(1) of Directive 2008/56/EC. CHAPTER II Priority 2: Fostering sustainable aquaculture activities and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union. Article 50 Market intelligence The EMFAF shall support the development and dissemination of market intelligence for fishery and aquaculture products by the Commission in accordance with Article 42 of Regulation (EU) No 1379/2013. CHAPTER III Priority 3: Enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities Article 51 Maritime policy and development of a sustainable blue economy The EMFAF shall support the implementation of the maritime policy and the development of a sustainable blue economy through: (a) the promotion of a sustainable, low carbon and climate resilient blue economy; (b) the promotion of an integrated governance and management of the maritime policy, including through maritime spatial planning, sea basin strategies and maritime regional cooperation; (c) the enhancement of the transfer and uptake of research, innovation and technology in the sustainable blue economy; (d) the improvement of maritime skills, ocean literacy and sharing of socio-economic and environmental data on the sustainable blue economy; (e) the development of project pipelines and innovative financing instruments. CHAPTER IV Priority 4: Strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed Article 52 European marine observation and data network The EMFAF shall support the implementation of the EMODnet. Article 53 Maritime security and surveillance The EMFAF shall support the promotion of maritime security and surveillance, including through data sharing, cooperation among coast guards and among agencies, and the fight against criminal and illegal activities at sea. Article 54 International ocean governance The EMFAF shall support the implementation of the international ocean governance policy through: (a) voluntary contributions to international organisations active in the field of ocean governance; (b) voluntary cooperation with, and coordination among, international fora, organisations, bodies and institutions in the context of the United Nations Convention on the Law of the Sea, the \u20182030 Agenda\u2019 and other relevant international agreements, arrangements and partnerships; (c) the implementation of ocean partnerships between the Union and relevant ocean actors; (d) the implementation of relevant international agreements, arrangements and instruments that aim to promote better ocean governance, as well as the development of actions, measures, tools and knowledge that enable safe, secure, clean and sustainably managed seas and oceans; (e) the implementation of relevant international agreements, measures and tools to prevent, deter and eliminate IUU fishing; (f) international cooperation on, and development of, ocean research and data. CHAPTER V Rules for implementation under direct and indirect management Article 55 Forms of Union funding 1. The EMFAF may provide funding in any of the forms laid down in the Financial Regulation, in particular procurement and grants pursuant to Titles VII and VIII of that Regulation, respectively. It may also provide financing in the form of financial instruments within blending operations, as referred to in Article 56 of this Regulation. 2. The evaluation of grant proposals may be carried out by independent experts. Article 56 Blending operations Blending operations under the EMFAF shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. Article 57 Evaluation by the Commission 1. Evaluations shall be carried out in a timely manner to feed into the decision-making process. Evaluations shall be entrusted to internal or external experts who are functionally independent. 2. The interim evaluation of the support under Title III shall be performed by the end of 2024. 3. A final evaluation report on the support under Title III shall be prepared by the end of 2031. 4. The Commission shall communicate the evaluation reports referred to in paragraphs 2 and 3 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 58 Monitoring under direct and indirect management 1. The Commission shall use the result and output indicators set out in Annex I to monitor the results of the implementation of the EMFAF under direct and indirect management. 2. The Commission shall collect data on operations selected for support under direct and indirect management, including key characteristics of the beneficiary and the operation, as set out in Article 46(3). Article 59 Audits Audits on the use of the Union contribution carried out by persons or entities, including by persons or entities other than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. Article 60 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the EMFAF, to actions taken pursuant to the EMFAF and to the results obtained. Financial resources allocated to the EMFAF shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the priorities referred to in Article 3. Article 61 Eligible entities, activities and costs 1. The eligibility criteria set out in paragraphs 2 and 3 of this Article shall apply in addition to the criteria set out in Article 197 of the Financial Regulation. 2. The following entities shall be eligible: (a) legal entities established in a Member State or in a third country listed in the work programme under the conditions specified in paragraphs 3 and 4; (b) any legal entity created under Union law or any international organisation. 3. Legal entities established in a third country shall be exceptionally eligible to participate where this is necessary for the achievement of the objectives of a given action. 4. Legal entities established in a third country which is not associated to the programme shall in principle bear the cost of their participation. 5. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation and by way of derogation from Article 193(4) thereof, taking into account the delayed entry into force of this Regulation and in order to ensure continuity, as established in the financing decision and for a limited period, activities supported under this Regulation and the underlying costs may be considered eligible as of 1 January 2021, even if the activities were implemented and the costs incurred before the grant application was submitted. TITLE IV PROCEDURAL PROVISIONS Article 62 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 11, 36, 46 and 65 shall be conferred on the Commission from 14 July 2021 until 31 December 2027. 3. The delegation of power referred to in Articles 11, 36, 46 and 65 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 11, 36, 46 and 65 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. Article 63 Committee procedure 1. The Commission shall be assisted by a Committee for the European Maritime, Fisheries and Aquaculture Fund. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. TITLE V FINAL PROVISIONS Article 64 Amendments to Regulation (EU) 2017/1004 Article 6 of Regulation (EU) 2017/1004 is amended as follows: (1) paragraphs 1 and 2 are replaced by the following: \u20181. Without prejudice to their current data collection obligations under Union law, Member States shall collect data within the framework of a work plan drawn up in accordance with the multiannual Union programme (the \u2018national work plan\u2019). Member States shall submit to the Commission by electronic means their national work plans by 15 October of the year preceding the year from which the national work plan is to apply, unless an existing plan still applies, in which case they shall notify the Commission thereof. 2. The Commission shall adopt implementing acts approving the national work plans referred to in paragraph 1 by 31 December of the year preceding the year from which the national work plan is to apply. When approving the national work plans, the Commission shall take into account the evaluation conducted by STECF in accordance with Article 10. If such evaluation indicates that the national work plan does not comply with this Article or does not ensure the scientific relevance of the data or sufficient quality of the proposed methods and procedures, the Commission shall immediately inform the Member State concerned and indicate amendments to that work plan that the Commission considers necessary. Subsequently, the Member State concerned shall submit a revised national work plan to the Commission.\u2019; (2) the following paragraph is added: \u20185. The Commission may adopt implementing acts laying down rules on procedures, format and timetables for the submission of the national work plans referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).\u2019. Article 65 Transitional provisions 1. Regulation (EU) No 508/2014 and any delegated and implementing act adopted pursuant to that Regulation shall continue to apply to programmes and operations supported from the EMFF under the 2014-2020 programming period. 2. In order to facilitate the transition from the support scheme established by Regulation (EU) No 508/2014 to the scheme established by this Regulation, the Commission is empowered to adopt delegated acts, in accordance with Article 62 of this Regulation, to lay down the conditions under which support approved by the Commission under Regulation (EU) No 508/2014 may be integrated into support provided under this Regulation. 3. References to Regulation (EU) No 508/2014 shall be construed as references to this Regulation with regard to the programming period for 2021-2027. Article 66 Entry into force and date of application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021 with regard to the support under direct and indirect management provided for in Title III. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 7 July 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. LOGAR (1) OJ C 110, 22.3.2019, p. 104. (2) OJ C 361, 5.10.2018, p. 9. (3) Position of the European Parliament of 4 April 2019 (OJ C 116, 31.3.2021, p. 81) and position of the Council at first reading of 14 June 2021 (OJ C 271, 7.7.2021, p. 1). Position of the European Parliament of 5 July 2021 (not yet published in the Official Journal). (4) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (5) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). (6) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (7) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (8) Regulation (EU) No 508/2014 of the European Parliament and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council (OJ L 149, 20.5.2014, p. 1). (9) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (10) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (11) Council Directive (EU) 2017/159 of 19 December 2016 implementing the Agreement concerning the implementation of the Work in Fishing Convention, 2007 of the International Labour Organisation, concluded on 21 May 2012 between the General Confederation of Agricultural Cooperatives in the European Union (Cogeca), the European Transport Workers\u2019 Federation (ETF) and the Association of National Organisations of Fishing Enterprises in the European Union (Europ\u00eache) (OJ L 25, 31.1.2017, p. 12). (12) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (13) Regulation (EU) 2017/1004 of the European Parliament and of the Council of 17 May 2017 on the establishment of a Union framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the common fisheries policy and repealing Council Regulation (EC) No 199/2008 (OJ L 157, 20.6.2017, p. 1). (14) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). (15) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). (16) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (17) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, p. 1). (18) Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 1). (19) OJ L 123, 12.5.2016, p. 1. (20) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (21) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (22) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (23) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (24) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union\u2019s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (25) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (26) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (27) Regulation (EU) 2017/352 of the European Parliament and of the Council of 15 February 2017 establishing a framework for the provision of port services and common rules on the financial transparency of ports (OJ L 57, 3.3.2017, p. 1). (28) Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, p. 11). (29) Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (OJ L 155, 12.6.2019, p. 1). (30) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (31) Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28). (32) Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (\u2018Animal Health Law\u2019) (OJ L 84, 31.3.2016, p. 1). (33) Directive 2014/89/EU of the European Parliament and of the Council of 23 July 2014 establishing a framework for maritime spatial planning (OJ L 257, 28.8.2014, p. 135). (34) Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, p. 1). (35) Regulation (EC) No 1406/2002 of the European Parliament and of the Council of 27 June 2002 establishing a European Maritime Safety Agency (OJ L 208, 5.8.2002, p. 1). (36) Regulation (EU) 2019/473 of the European Parliament and of the Council of 19 March 2019 on the European Fisheries Control Agency (OJ L 83, 25.3.2019, p. 18). (37) Council Decision (EU) 2015/1565 of 14 September 2015 on the approval, on behalf of the European Union, of the Declaration on the granting of fishing opportunities in EU waters to fishing vessels flying the flag of the Bolivarian Republic of Venezuela in the exclusive economic zone off the coast of French Guiana (OJ L 244, 19.9.2015, p. 55). ANNEX I COMMON INDICATORS OF THE EMFAF CORE PERFORMANCE INDICATORS (1) RESULT INDICATORS (MEASUREMENT UNIT) OUTPUT INDICATOR CI 01 - Businesses created CI 02 - Businesses with higher turnover CI 03 - Jobs created CI 04 - Jobs maintained CI 05 - Persons benefitting CI 06 - Actions contributing to a good environmental status, including nature restoration, conservation, protection of ecosystems, biodiversity, animal health and welfare CI 07 - Energy consumption leading to CO2 emissions reduction CI 08 - Number of SMEs supported CR 01 - New production capacity (tonnes/annum) CR 02 - Aquaculture production maintained (tonnes/annum) CR 03 - Businesses created (number of entities) CR 04 - Businesses with higher turnover (number of entities) CR 05 - Capacity of vessels withdrawn (GT and kW) CR 06 - Jobs created (number of persons) CR 07 - Jobs maintained (number of persons) CR 08 - Persons benefitting (number of persons) CR 09 - Area addressed by operations contributing to a good environmental status, protecting, conserving, and restoring biodiversity and ecosystems (km2 or km) CR 10 - Actions contributing to a good environmental status, including nature restoration, conservation, protection of ecosystems, biodiversity, animal health and welfare (number of actions) CR 11 - Entities increasing social sustainability (number of entities) CO 01 - Number of operations CI 09 - Number of fishing vessels equipped with electronic position and catch reporting devices CI 10 - Number of local action groups CI 11 - Number of small scale coastal fishing vessels supported CI12 - Usage of data and information platforms CR 12 - Effectiveness of the system for \u201ccollection, management and use of data\u201d (scale: high, medium, low) CR 13 - Cooperation activities between stakeholders (number of actions) CR 14 - Innovations enabled (number of new products, services, processes, business models or methods) CR 15 - Control means installed or improved (number of means) CR 16 - Entities benefitting from promotion and information activities (number of entities) CR 17 - Entities improving resource efficiency in production and/or processing (number of entities) CR 18 - Energy consumption leading to CO2 emissions reduction (kWh/tonnes or litres/h) CR 19 - Actions to improve governance capacity (number of actions) CR 20 - Investment induced (EUR) CR 21 - Datasets and advice made available (number) CR 22 - Usage of data and information platforms (number of page views) (1) Core performance indicators for EMFAF to be used by the Commission in compliance with its reporting requirement pursuant to paragraph (iii) of point (h) of Article 41(3) of the Financial Regulation. ANNEX II ORGANISATION OF SUPPORT UNDER SHARED MANAGEMENT POLICY OBJECTIVE Article 5 of Regulation (EU) 2021/1060 EMFAF PRIORITY EMFAF SPECIFIC OBJECTIVE NOMENCLATURE TO BE USED IN THE FINANCING PLAN Table 11A of Annex V to Regulation (EU) 2021/1060 A greener, low-carbon transitioning towards a net zero carbon economy and resilient Europe by promoting clean and fair energy transition, green and blue investment, the circular economy, climate change mitigation and adaptation, risk prevention and management, and sustainable urban mobility Fostering sustainable fisheries and the restoration and conservation of aquatic biological resources Strengthening economically, socially and environmentally sustainable fishing activities 1.1.1 all operations except those supported under Articles 17 and 19 1.1.2 operations supported under Articles 17 and 19 Increasing energy efficiency and reducing CO2 emissions through the replacement or modernisation of engines of fishing vessels 1.2 Promoting the adjustment of fishing capacity to fishing opportunities in cases of permanent cessation of fishing activities and contributing to a fair standard of living in cases of temporary cessation of fishing activities 1.3 Fostering efficient fisheries control and enforcement, including fighting against IUU fishing, as well as reliable data for knowledge-based decision-making 1.4 Promoting a level-playing field for fishery and aquaculture products from the outermost regions 1.5 Contributing to the protection and restoration of aquatic biodiversity and ecosystems 1.6 Fostering sustainable aquaculture activities, and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union Promoting sustainable aquaculture activities, especially strengthening the competitiveness of aquaculture production, while ensuring that the activities are environmentally sustainable in the long term 2.1 Promoting marketing, quality and added value of fishery and aquaculture products, as well as processing of those products 2.2 Strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed Strengthening sustainable sea and ocean management through the promotion of marine knowledge, maritime surveillance or coast guard cooperation 4.1 A Europe closer to citizens by fostering the sustainable and integrated development of all types of territories and local initiatives Enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities Enabling a sustainable blue economy in coastal, island and inland areas, and fostering the sustainable development of fishing and aquaculture communities 3.1 Technical assistance 5.1 5.2 ANNEX III SPECIFIC MAXIMUM AID INTENSITY RATES UNDER SHARED MANAGEMENT ROW NUMBER SPECIFIC CATEGORY OF OPERATION MAXIMUM AID INTENSITY RATE 1 Operations supported under Articles 17, 18 and 19 40 % 2 The following operations contributing to the implementation of the landing obligation referred to in Article 15 of Regulation (EU) No 1380/2013: \u2014 operations improving size selectivity or species selectivity of fishing gear; 100 % \u2014 operations improving the infrastructure of fishing ports, auction halls, landing sites and shelters in order to facilitate the landing and storage of unwanted catches; 75 % \u2014 operations facilitating the marketing of unwanted catches landed from commercial stocks, in accordance with point (b) of Article 8(2) of Regulation (EU) No 1379/2013 75 % 3 Operations aimed at improving the health, safety and working conditions on board fishing vessels, with the exception of operations supported under Article 19 75 % 4 Operations located in the outermost regions 85 % 5 Operations located in the remote Greek Islands and in the Croatian islands of Dugi Otok, Vis, Mljet and Lastovo 85 % 6 Operations supported under Article 22 85 % 7 Operations related to small-scale coastal fishing 100 % 8 Operations for which the beneficiary is a public body or an undertaking entrusted with the operation of services of general economic interest as referred to in Article 106(2) TFEU, where support is granted for the operation of such services 100 % 9 Operations related to the compensation referred to in Article 39 100 % 10 Operations supported under Articles 23 and 25 and under Priority 4 100 % 11 Operations related to the design, development, monitoring, evaluation or management of transparent systems for exchanging fishing opportunities between Member States, in accordance with Article 16(8) of Regulation (EU) No 1380/2013 100 % 12 Operations related to the running costs of local actions groups 100 % 13 Operations supported under Article 30 and which fulfil at least one of the following criteria: (i) they are of collective interest; (ii) they have a collective beneficiary; or (iii) they have innovative features, where appropriate, at local level, and ensure public access to their results 100 % 14 Operations other than those covered in row 13 which fulfil all of the following criteria: (i) they are of collective interest; (ii) they have a collective beneficiary; (iii) they have innovative features or ensure public access to their results 100 % 15 Operations implemented by producer organisations, associations of producer organisations or interbranch organisations 75 % 16 Financial instruments, with the exception of financial instruments related to operations referred to in row 1 100 % 17 Operations supporting sustainable aquaculture implemented by SMEs 60 % 18 Operations supporting innovative products, processes or equipment in fisheries, aquaculture and processing 75 % 19 Operations implemented by organisations of fishers or other collective beneficiaries 60 % ANNEX IV TYPES OF INTERVENTION No TYPE OF INTERVENTION CLIMATE COEFFICIENT ENVIRONMENTAL COEFFICIENT 1 Reducing negative impacts and/or contributing to positive impacts on the environment and contributing to a good environmental status 100 % 100 % 2 Promoting conditions for economically viable, competitive and attractive fishery, aquaculture and processing sectors 40 % 40 % 3 Contributing to climate neutrality 100 % 100 % 4 Temporary cessation of fishing activities 100 % 100 % 5 Permanent cessation of fishing activities 100 % 100 % 6 Contributing to a good environmental status through implementing and monitoring of marine protected areas, including Natura 2000 100 % 100 % 7 Compensation for unexpected environmental, climatic or public health events 0 % 0 % 8 Compensation for additional costs in outermost regions 0 % 0 % 9 Animal health and welfare 40 % 40 % 10 Control and enforcement 40 % 100 % 11 Data collection and analysis, and promotion of marine knowledge 100 % 100 % 12 Maritime surveillance and security 40 % 40 % Community-led local development (CLLD) 13 CLLD preparation actions 0 % 0 % 14 CLLD implementation of strategy 40 % 40 % 15 CLLD running costs and animation 0 % 0 % Technical assistance 16 Technical assistance 0 % 0 % ANNEX V GLOBAL RESOURCES FROM THE EMFAF PER MEMBER STATE FOR THE PERIOD FROM 1 JANUARY 2021 TO 31 DECEMBER 2027 2021 2022 2023 2024 2025 2026 2027 TOTAL TOTAL 649 646 302 867 704 926 833 435 808 798 047 503 707 757 512 721 531 085 732 876 864 5 311 000 000 BE 4 925 394 6 578 640 6 318 823 6 050 521 5 365 973 5 470 400 5 556 420 40 266 171 BG 10 390 512 13 878 165 13 330 060 12 764 057 11 319 949 11 540 245 11 721 710 84 944 698 CZ 3 670 269 4 902 222 4 708 614 4 508 683 3 998 577 4 076 392 4 140 492 30 005 249 DK 24 582 747 32 834 129 31 537 379 30 198 278 26 781 687 27 302 881 27 732 208 200 969 309 DE 25 908 996 34 605 542 33 238 833 31 827 487 28 226 569 28 775 883 29 228 372 211 811 682 EE 11 912 962 15 911 637 15 283 223 14 634 286 12 978 583 13 231 157 13 439 212 97 391 060 IE 17 414 773 23 260 170 22 341 533 21 392 895 18 972 532 19 341 754 19 645 895 142 369 552 EL 45 869 836 61 266 389 58 846 736 56 348 059 49 972 919 50 945 434 51 746 530 374 995 903 ES 137 053 465 183 056 482 175 826 854 168 361 115 149 312 971 152 218 730 154 612 307 1 120 441 924 FR 69 372 651 92 658 097 88 998 661 85 219 712 75 578 071 77 048 886 78 260 448 567 136 526 HR 29 808 019 39 813 303 38 240 917 36 617 179 32 474 362 33 106 342 33 626 925 243 687 047 IT 63 388 749 84 665 656 81 321 871 77 868 885 69 058 907 70 402 853 71 509 909 518 216 830 CY 4 685 786 6 258 605 6 011 428 5 756 178 5 104 932 5 204 279 5 286 114 38 307 322 LV 16 498 239 22 035 996 21 165 707 20 266 995 17 974 015 18 323 805 18 611 939 134 876 696 LT 7 484 030 9 996 101 9 601 315 9 193 636 8 153 481 8 312 155 8 442 859 61 183 577 LU - - - - - - - - HU 4 612 763 6 161 072 5 917 747 5 666 475 5 025 378 5 123 176 5 203 735 37 710 346 MT 2 669 689 3 565 790 3 424 963 3 279 536 2 908 494 2 965 097 3 011 721 21 825 290 NL 11 978 187 15 998 755 15 366 900 14 714 410 13 049 642 13 303 600 13 512 794 97 924 288 AT 821 763 1 097 594 1 054 246 1 009 482 895 270 912 693 927 046 6 718 094 PL 62 675 756 83 713 340 80 407 168 76 993 019 68 282 136 69 610 965 70 705 569 512 387 953 PT 46 307 271 61 850 651 59 407 923 56 885 418 50 449 481 51 431 271 52 240 007 378 572 022 RO 19 871 141 26 541 038 25 492 826 24 410 382 21 648 625 22 069 926 22 416 967 162 450 905 SI 2 927 095 3 909 597 3 755 191 3 595 743 3 188 925 3 250 985 3 302 105 23 929 641 SK 1 862 388 2 487 512 2 389 271 2 287 821 2 028 980 2 068 465 2 100 991 15 225 428 FI 8 777 254 11 723 405 11 260 401 10 782 276 9 562 384 9 748 476 9 901 766 71 755 962 SE 14 176 567 18 935 038 18 187 218 17 414 975 15 444 669 15 745 235 15 992 823 115 896 525", "summary": "European Maritime, Fisheries and Aquaculture Fund (2021\u20132027) European Maritime, Fisheries and Aquaculture Fund (2021\u20132027) SUMMARY OF: Regulation (EU) 2021/1139 establishing the European Maritime, Fisheries and Aquaculture Fund WHAT IS THE AIM OF THE REGULATION? It establishes the European Maritime, Fisheries and Aquaculture Fund (EMFAF), a European Union (EU) fund which runs over the 2021\u20132027 period in the context of the 2021\u20132027 multiannual financial framework. It sets out the fund\u2019s priorities, its budget and the specific rules for providing EU funding, complementary to the general rules applying to the EMFAF under Regulation (EU) 2021/1060 (see summary). KEY POINTS Priorities The EMFAF supports the EU\u2019s common fisheries policy, the EU maritime policy and the EU agenda for international ocean governance. This helps to fulfil the objectives of the European Green Deal and contributes to the protection of marine biodiversity, to the EU\u2019s climate change mitigation objectives and to food supply. The EMFAF supports innovative projects that contribute to the sustainable use and management of aquatic and maritime resources. In particular, it facilitates: sustainable and low-carbon fishing activities; the protection of marine biodiversity and ecosystems; the supply of quality and healthy seafood to European consumers through an efficient market for fisheries products; the socioeconomic attractiveness and generational renewal of the fisheries sector, in particular as regards small-scale coastal fisheries; the structural management of fisheries and fishing fleets (eliminating fleet overcapacity and supporting measures for the conservation of marine biological resources); the collection of scientific data to underpin fisheries management; the control of fishing activities and the promotion of a culture of compliance in the fishing sector, to ensure a level playing field; the development of sustainable and competitive aquaculture, contributing to food security; the improvement of skills and working conditions in fisheries and aquaculture; the economic and social vitality of coastal communities; innovation in the sustainable blue economy; maritime security, contributing to a safe maritime space; international cooperation, contributing to healthy, safe and sustainably managed oceans. In pursuing these objectives, the EMFAF has a specific focus on the sustainability and profitability of small-scale coastal fishing and on the sustainable development of maritime activities in the outermost regions. Budget For 2021\u20132027, the EMFAF budget is \u20ac6,108,000,000 (at 2021 prices), divided as follows: shared management \u2014 \u20ac5,311,000,000 provided through national programmes co-financed by the EU budget and the EU Member States; direct and indirect management \u2014 \u20ac797,000,000 provided by the European Commission. Annex V lists the global resources from the EMFAF per Member State for each of the years from 2021 to 2027. For operations in the outermost regions, the Member States concerned must allocate from these global amounts at least: \u20ac102,000,000 for the Azores and Madeira (Portugal); \u20ac82,000,000 for the Canary Islands (Spain); \u20ac131,000,000 for French Guiana, Guadeloupe, Martinique, Mayotte, R\u00e9union and Saint Martin (France). Programming Under shared management, each Member State prepares a single national programme, which the Commission approves after an in-depth assessment. A national EMFAF programme is a strategic roadmap for public investment between 2021 and 2027. It describes tailor-made actions to respond to the specific challenges identified by the Member States as regards the common EU priorities for marine biodiversity, maritime policy and sustainable fisheries and aquaculture. Evaluation and monitoring The EMFAF\u2019s implementation is continuously monitored in a transparent manner, in accordance with the common rules set in Regulation (EU) 2021/1060 and the specific rules in the EMFAF regulation. Twice each year, Member States report: on the values of the indicators selected in their EMFAF programmes \u2014 this information is aggregated at EU level and made publicly available;on the detailed characteristics of each project and beneficiary \u2014 the Commission uses this information for regular ad hoc reporting. Five times each year, Member States report on the number of selected projects and on their financial cost. This information is aggregated at EU level and made publicly available. It is also broken down according to thematic areas. The Commission discusses the EMFAF\u2019s implementation with each Member State in an annual review meeting. This meeting aims to identify potential issues in the national EMFAF programme and corrective actions, if necessary. By 30 June 2029, each Member State will evaluate its EMFAF programme to assess its impact. By the end of 2024 and also by the end of 2031, the Commission will evaluate the effectiveness, efficiency, relevance, coherence and EU added value of the EMFAF as a whole. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND For more information, see: European Maritime, Fisheries and Aquaculture Fund (EMFAF) (European Commission). MAIN DOCUMENT Regulation (EU) 2021/1139 of the European Parliament and of the Council of 7 July 2021 establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 (OJ L 247, 13.7.2021, pp. 1\u201349). RELATED DOCUMENTS Commission Delegated Regulation (EU) 2021/1972 of 11 August 2021 supplementing Regulation (EU) 2021/1139 of the European Parliament and of the Council establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 by laying down the criteria for the calculation of the additional costs incurred by operators in the fishing, farming, processing and marketing of certain fishery and aquaculture products from the outermost regions (OJ L 402, 15.11.2021, pp. 1\u20133). Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, pp. 159\u2013706). Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 on a new approach for a sustainable blue economy in the EU \u2014 Transforming the EU\u2019s Blue Economy for a Sustainable Future (COM(2021) 240 final, 17.5.2021). Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 EU Biodiversity Strategy for 2030 \u2014 Bringing nature back into our lives (COM(2020) 380 final, 20.5.2020). Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 The European Green Deal (COM(2019) 640 final, 11.12.2019). Regulation (EU) 2017/1004 of the European Parliament and of the Council of 17 May 2017 on the establishment of a Union framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the common fisheries policy and repealing Council Regulation (EC) No 199/2008 (OJ L 157, 20.6.2017, pp. 1\u201321). Successive amendments to Regulation (EU) 2017/1004 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, pp. 1\u201321). See consolidated version. Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1\u201350). See consolidated version. Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, pp. 19\u201340). See consolidated version. last update 26.11.2021"}
{"article": "26.1.2021 EN Official Journal of the European Union L 24/1 REGULATION (EU) 2021/56 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 January 2021 laying down management, conservation and control measures applicable in the Inter-American Tropical Tuna Convention area and amending Council Regulation (EC) No 520/2007 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The objective of the Common Fisheries Policy, as set out in Regulation (EU) No 1380/2013 of the European Parliament and of the Council (3), is to ensure an exploitation of marine biological resources that provides sustainable economic, environmental and social conditions. (2) By means of Council Decision 98/392/EC (4), the Union approved the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement for the Implementation of that Convention relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks (5), which contain principles and rules with regard to the conservation and management of the living resources of the sea. In the framework of its wider international obligations, the Union participates in efforts made in international waters to conserve fish stocks. (3) By means of Council Decision 2006/539/EC (6), the Union approved the Convention for the Strengthening of the Inter-American Tropical Tuna Commission established by the 1949 Convention between the United States of America and the Republic of Costa Rica (\u2018the Convention\u2019). (4) The Inter-American Tropical Tuna Commission (IATTC) has the authority to adopt decisions (\u2018Resolutions\u2019) to ensure the long-term conservation and sustainable use of the fishery resources in the Convention area. Resolutions are binding for the Contracting Parties. Resolutions are essentially addressed to the Contracting Parties to the Convention, but also contain obligations for private operators (e.g. masters of vessels). Resolutions enter into force 45 days following their adoption and, in respect of the Union, they must be implemented into Union law as soon as possible. (5) By means of Council Decision 2005/938/EC (7), the Union approved the Agreement on the International Dolphin Conservation Programme (\u2018the Agreement\u2019), which established the International Dolphin Conservation Programme (IDCP). (6) Under Article XIV of the Agreement, the IATTC is to have an integral role in coordinating the implementation of the Agreement and in implementing the measures that will be adopted within the framework of the IATTC. (7) Within the IDCP, the Meeting of the Parties is responsible for the adoption of measures designed to progressively reduce incidental dolphin mortality in the tuna purse seine fishery in the Agreement Area to levels approaching zero, through the setting of annual limits. Such measures become binding upon the Union. (8) The most recent implementation of the Resolutions was carried out through Council Regulation (EC) No 520/2007 (8). (9) Taking into consideration that Resolutions are likely to be amended at the annual meetings of the IATTC, and in order to swiftly incorporate them into Union law, to reinforce the level playing field and further support the long-term sustainable management of the stocks, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the following aspects: the technical specifications for shark lines, closure periods, fish-aggregating devices (FADs) reporting timelines, provisions concerning design and deployment of FADs, data collection deadlines, areas and mitigation measures for the protection of seabirds, scientific observer coverage, information related to the Regional Vessel Register, reference to table for provision of data for the logbooks and unloading records, the bigeye tuna statistical document, several reporting deadlines and the turtle mortality guidelines. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (9). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (10) The delegation of powers provided for in this Regulation should be without prejudice to the implementation of future Resolutions into Union law through the ordinary legislative procedure. (11) Since this Regulation implements all IATTC measures, Article 3(3), Article 4(3) and Title IV of Regulation (EC) No 520/2007 should be deleted, HAVE ADOPTED THIS REGULATION: CHAPTER I General Provisions Article 1 Subject matter This Regulation lays down management, conservation and control measures relating to fishing in the area covered under the Convention and with respect to stocks of tunas and tuna-like species, other species of fish taken by vessels fishing for tunas and tuna-like species and species belonging to the same ecosystem that are affected by fishing for, or dependent on or associated with, the fish stocks covered by the Convention. Article 2 Scope 1. This Regulation applies to Union fishing vessels used or intended for use for the purposes of fishing in the area covered under the Convention. 2. Unless otherwise stated in this Regulation, it applies without prejudice to the existing Regulations in the fisheries sector, in particular Regulation (EU) 2017/2403 of the European Parliament and of the Council (10) and Council Regulations (EC) No 1005/2008 (11), (EC) No 1224/2009 (12) and (EC) No 1185/2003 (13). Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018the Convention\u2019 means the Convention for the Strengthening of the Inter-American Tropical Tuna Commission established by the 1949 Convention between the United States of America and the Republic of Costa Rica; (2) \u2018the Convention area\u2019 means the geographical area to which the Convention applies as described in Article III of the Convention; (3) \u2018IATTC species\u2019 means stocks of tunas and tuna-like species and other species of fish taken by vessels fishing for tunas and tuna-like species in the Convention area; (4) \u2018Union fishing vessel\u2019 means any vessel flying the flag of a Member State, used or intended for use for the purposes of commercial exploitation of fishery resources, including support vessels, fish processing vessels, vessels engaged in transhipment and carrier vessels equipped for the transportation of fishery products, except container vessels; (5) \u2018Contracting Party\u2019 means the contracting parties to the Convention; (6) \u2018purse seine\u2019 means any encircling net the bottom of which is drawn together by means of a purse line at the bottom of the net, which passes through a series of rings along the ground rope, enabling the net to be pursed and closed; (7) \u2018tropical tunas\u2019 means bigeye tuna, yellowfin tuna and skipjack tuna; (8) \u2018data buoys\u2019 means floating devices, either drifting or anchored, that are deployed by governmental or recognised scientific organisations or entities for the purpose of electronically collecting environmental data, and not in support of fishing activities, and which have been notified to the IATTC Secretariat; (9) \u2018fish-aggregating device\u2019 or \u2018FAD\u2019 means anchored, drifting, floating or submerged objects deployed or tracked by vessels, including through the use of radio or satellite buoys, for the purpose of aggregating target tuna species for purse seine fishing operations; (10) \u2018interaction\u2019 with data buoys includes, but is not limited to, encircling the buoy with fishing gear, tying up or attaching the vessel, fishing gear, or any part or portion of the vessel, to a data buoy, or cutting its anchor line; (11) \u2018operator\u2019 means the natural or legal person who operates or holds any undertaking carrying out any of the activities related to any stage of production, processing, marketing, distribution and retail chains of fisheries and aquaculture products; (12) \u2018SAC\u2019 means the Scientific Advisory Committee established under Article XI of the Convention; (13) \u2018transhipment\u2019 means the unloading of all or any fisheries products on board a vessel to another vessel; (14) \u2018Regional Vessel Register\u2019 means the vessel register of the IATTC; (15) \u2018Resolution\u2019 means the binding measures adopted by the IATTC under Article VII of the Convention; (16) \u2018IATTC transhipment declaration form\u2019 means the document contained in Annex 2 to Resolution C-12-07; (17) \u2018observer\u2019 means a person who is authorised and certified by a Member State or Contracting Party to observe, monitor and collect information on board fishing vessels; (18) \u2018longline\u2019 means a fishing gear which comprises a main line carrying numerous hooks on branch lines (snoods) of variable length and spacing depending on target species; (19) \u2018shark lines\u2019 means individual lines attached to the float line or to the floats directly, and used to target sharks, as depicted in Figure 1 of Resolution C-16-05; (20) \u2018large circle hook\u2019 means a hook with the point turned perpendicularly back to the shank to form a generally circular or oval shape, and the point of the hook not offset more than 10 degrees; (21) \u2018the Agreement\u2019 means the Agreement on the International Dolphin Conservation Programme (AIDCP); (22) \u2018sealed wells\u2019 means any space on board a vessel, intended for the freezing, maintenance or storage of fish, access to which has been blocked to prevent its use for those purposes; (23) \u2018WCPFC\u2019 means the Fisheries Commission for the Western and Central Pacific Ocean established under the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (14); (24) \u2018overlap area\u2019 means the area of overlapping competence between the IATTC and WCPFC geographical areas. That area is the part of the Pacific Ocean bounded by the following lines: the 50\u00b0S parallel from its intersection with meridian 150\u00b0W until the intersection with meridian 130\u00b0W, and the 4\u00b0S parallel from its intersection with meridian 150\u00b0W until the intersection with meridian 130\u00b0W. CHAPTER II Conservation and Management Measures Article 4 Closure periods for purse seine vessels for tropical tunas 1. To implement the fishing closure for purse seine vessels, each Member State shall: (a) inform the Commission by 15 June each year of which of the two closure periods from 29 July to 8 October, or from 9 November to 19 January, shall be applicable to their vessels. The Commission shall notify the IATTC Secretariat of the applicable period of closure by 15 July each year; (b) inform all interested parties in its tuna industry of the closure; (c) inform the Commission by 15 June each year that these steps have been taken; (d) ensure that for the entire duration of the closure all purse seine vessels that fly its flag do not fish in the Convention area. 2. Where a Union fishing vessel is unable to proceed to sea outside the applicable closure period referred to in point (a) of paragraph 1, due to a force majeure event consisting of disabling the fishing vessel in the course of fishing operations by mechanical or structural failure, fire or explosion, during a period of at least 75 consecutive days, the Member State may send to the Commission an exemption request for the closure period, together with the evidence necessary to demonstrate that the vessel did not proceed to sea due to force majeure. The request shall be sent to the Commission at the latest two weeks after the cessation of the cause of the force majeure. The Commission shall assess and, where applicable, forward the request to the IATTC Secretariat for consideration by the IATTC at the latest one month after the cessation of the cause of the force majeure. 3. Where the Commission notifies the Member State of the approval by the IATTC of the request referred to in paragraph 2: (a) in the event that the vessel has not observed a closure period in the same year where the cause of the force majeure occurred, the vessel shall observe a reduced closure period of 40 consecutive days in one of the two closure periods of that year instead of the full closure set out in point (a) of paragraph 1 and the Commission shall immediately notify the IATTC Secretariat of the chosen period of closure; or (b) in the event that the vessel has already observed a closure period in the same year during which the cause of the force majeure occurred, it shall observe a reduced closure period of 40 consecutive days the following year in one of the two closure periods for that year, to be notified to the Commission no later than 15 July of that year. 4. Any vessel that benefits from the exemption provided for in paragraph 3 shall carry an authorised observer on-board. 5. In addition to the closure referred to in paragraph 1, the fishery for tropical tunas within the area of 96\u00b0 and 110\u00b0W and between 4\u00b0N and 3\u00b0S shall be closed from 9 October to 8 November of each year. Article 5 Prohibition of fishing on data buoys 1. Masters of vessels shall ensure that their vessels do not interact with data buoys in the Convention area. 2. It shall be prohibited to deploy fishing gear within one nautical mile of an anchored data buoy in the Convention area. 3. It shall be prohibited to take on board a data buoy, unless a Member State, a Contracting Party or the owner responsible for that buoy specifically authorises or requests to do so. 4. If fishing gear becomes entangled with a data buoy, the entangled fishing gear shall be removed with as little damage to the data buoy as possible. 5. Scientific research programmes formally notified to the IATTC may operate Union fishing vessels within one nautical mile of a data buoy, provided that those vessels do not interact with the data buoy or deploy fishing gear, as set out in paragraphs 1 and 2. Article 6 Fish-aggregating devices (FADs) 1. FADs shall be activated exclusively on board Union purse seine vessels. 2. A FAD shall be considered active when it is deployed at sea, starts transmitting its location and is being tracked by the vessel, its owner or its operator. 3. Union fishing vessels shall report daily information on all active FADs to the Commission at intervals submitted with a time delay of at least 60 days, but with a time interval of not more than 90 days between each report. The Commission shall immediately forward that information to the IATTC Secretariat. 4. The operators of Union fishing vessels shall collect and report any interaction with FADs to Member States. For each interaction they shall record the following information: (a) position of the FAD; (b) date and hour of deployment of the FAD; (c) IATTC FAD identification (i.e. FAD marking or beacon identification; type of buoy; or any information allowing identification of the owner); (d) FAD type (such as anchored FAD, drifting natural FAD, drifting artificial FAD); (e) FAD design characteristics (dimension and material of the floating part and of the underwater hanging structure); (f) type of activity (set, deployment, hauling, retrieving, loss, intervention on electronic equipment, etc.); (g) if the activity is a set, the results of the set in terms of catch and bycatch; and (h) characteristics of any attached buoy or positioning equipment (positioning system, whether equipped with sonar, etc.). 5. The data collected for the previous calendar year shall be submitted by Member States to the Commission no later than 75 days prior to each regular meeting of the SAC. The Commission shall forward that information to the IATTC Secretariat no later than 60 days before the meeting of the SAC. 6. The identification and the design and deployment of FADs by Union fishing vessels shall comply, respectively, with Annexes I and II to Resolution C-19-01. Article 7 Transhipments in port All transhipments in the Convention area of IATTC species shall take place in port. CHAPTER III Protection of marine species Section 1 Elasmobranch species Article 8 Oceanic whitetip sharks 1. It shall be prohibited to retain onboard, tranship, land, store, sell or offer for sale any part or whole carcass of oceanic whitetip sharks (Carcharhinus longimanus). 2. Whitetip sharks shall be, to the extent practicable, promptly released unharmed when brought alongside the vessel. 3. Member States, shall record, inter alia, through the observer programmes, the number of discards and releases of whitetip sharks, indicating the status (dead or alive), including those released under paragraph 2. Article 9 Mobulid rays 1. It shall be prohibited to retain onboard, tranship, land, store, sell or offer for sale any part or whole carcass of Mobulid rays (which includes Manta rays and Mobula rays) caught in the Convention area. 2. If Mobulid rays are unintentionally caught and frozen as part of a purse seine vessel operation, the vessel shall surrender the whole Mobulid ray to the responsible authorities at the point of landing. Mobulid rays surrendered in that manner shall not be sold or bartered but may be donated for purposes of domestic human consumption. 3. Mobulid rays that are caught unintentionally shall be promptly released unharmed, to the extent practicable, as soon as they are seen in the net, on the hook, or on the deck. Release shall be carried out in a manner that will result in the least possible harm to the Mobulid rays captured without compromising the safety of any persons, following the guidelines detailed in Annex 1 to IATTC Resolution C-15-04. 4. Member States shall record, inter alia, through the observer programmes, the number of discards and releases of Mobulid rays, indicating the status (dead or alive), including those surrendered under paragraph 2. Article 10 Silky sharks 1. It shall be prohibited to retain on board, tranship, land, store, sell or offer for sale any part or whole, carcasses of silky sharks (Carcharhinus falciformis) caught by purse seine vessels in the Convention area. 2. If silky sharks are unintentionally caught and frozen as part of a purse seine vessel operation, and if the governmental authorities are present at the point of landing, the whole silky shark shall be surrendered to them. If the governmental authorities are unavailable, the whole silky shark surrendered shall not be sold or bartered but may be donated for purposes of domestic human consumption. Silky sharks surrendered in this manner shall be reported to the IATTC Secretariat. 3. Longline vessels that catch sharks incidentally shall limit bycatch of silky sharks to a maximum of 20 % of the total catch by fishing trip in weight. 4. Union fishing vessels shall not fish in silky shark pupping areas identified by the IATTC. Article 11 Whale sharks 1. Union fishing vessels shall not set a purse seine net on a school of tunas associated with a live whale shark (Rhincodon typus), if the animal is sighted prior to the commencement of the set. 2. In the event that a whale shark is not deliberately encircled in the purse seine net, the master of the vessel shall: (a) ensure that all reasonable steps are taken to ensure its safe release; and (b) report the incident to the Member State, including the number of individuals concerned, details of how and why the encirclement happened, where it occurred, steps taken to ensure safe release, and an assessment of the life status of the animal(s) on release (including whether any were released alive but subsequently died). 3. Whale sharks shall not be towed out of a purse seine net. Article 12 Safe release of sharks by purse seine vessels 1. Union fishing vessels shall promptly release sharks (whether alive or dead) caught that are not retained unharmed, to the extent practicable, as soon as they are seen in the net or on the deck, without compromising the safety of any persons. 2. If a shark is alive when caught by purse seine vessels and is not retained, the shark shall be released by using the following procedures, or equally effective means: (a) sharks are released out of the net by directly releasing them from the brailer into the ocean; (b) sharks that cannot be released without compromising the safety of persons before being landed on deck are returned to the water as soon as possible, either utilising a ramp from the deck connecting to an opening on the side of the vessel, or through escape hatches; and (c) if ramps or escape hatches are not available, the sharks are lowered with a sling or cargo net, using a crane or similar equipment, if available. The use of gaffs, hooks or similar instruments shall be prohibited for the handling of sharks. No shark may be lifted by the head, tail, gill slits, or spiracles, or by using bind wire against or inserted through the body, and no holes may be punched through the bodies of sharks (e.g. to pass a cable through for lifting the shark). Article 13 Prohibition of use of shark lines by longline vessels Union longline fishing vessels shall not use shark lines. Article 14 Data collection on shark species 1. Masters of Union fishing vessels shall collect and submit catch data for silky and hammerhead sharks to the Member States, who shall send and submit those data to the Commission by 31 March each year. The Commission shall forward the data to the IATTC Secretariat. 2. Observers on Union fishing vessels shall record the number and status (dead or alive) of silky sharks and hammerhead sharks caught and released. Section 2 Other species Article 15 Seabirds 1. Longline vessels that use hydraulic, mechanical or electrical systems and that fish for species covered by the Convention in the area north of 23\u00b0N and south of 30\u00b0S, and the area bounded by the coastline at 2\u00b0N, west to 2\u00b0N-95\u00b0W, south to 15\u00b0S-95\u00b0W, east to 15\u00b0S-85\u00b0W, and south to 30\u00b0S shall apply at least two of the mitigation measures contained in the table in the Annex to this Regulation including at least one from Column A. Vessels shall not use the same measure from Column A and Column B. 2. Notwithstanding paragraph 1, side-setting with bird curtains and weighted branch lines shall only be applied in the area north of 23\u00b0N until research establishes the utility of this measure in waters south of 30\u00b0S. The use of side-setting with a bird curtain and weighted branch lines from column A shall be counted as two mitigation measures. 3. If the tori line is selected from both Column A and Column B, that shall equate to simultaneously using two (i.e. paired) tori lines. Article 16 Sea turtles 1. Union fishing vessels shall promptly release, in a manner that causes the least harm to the extent practicable, all sea turtles, without compromising the safety of any persons. At least one member of a Union fishing vessel\u2019s crew shall be trained in techniques for handling and release of sea turtles to improve survival after release. 2. Member States shall continue to participate in and promote research to identify techniques to further reduce sea turtle bycatch in all gear types used in the eastern Pacific Ocean. 3. The master of a purse seine vessel shall: (a) avoid encirclement of sea turtles to the extent practicable and carry on board, and employ when appropriate, safe-handling tools for the release of sea turtles and take all reasonable steps, in the event that a sea turtle is sighted in a purse seine net, to ensure its safe release; (b) take the actions necessary to monitor FADs for the entanglement of sea turtles, and ensure the release of all sea turtles entangled in FADs; (c) record all observed interactions involving sea turtles during purse seine fishing operations and report such information to the national authorities. 4. Masters of longline vessels shall: (a) carry on-board and, when sea turtle interactions occur, employ the necessary equipment (e.g. de-hookers, line cutters, and scoop nets) for the prompt release of sea turtles incidentally caught; (b) when the majority of hooks fish at depths shallower than 100 metres, employ one of the following two mitigation measures: large circle hooks or the use only of finfish for bait; (c) report any interactions to the national authorities. 5. Member States shall support research and development of modified FAD designs to reduce sea turtle entanglement as well as take measures to encourage the use of designs found to be successful at such reduction. Article 17 Protection of dolphins Only Union fishing vessels operating under the conditions laid down in the Agreement which have been allocated a Dolphin Mortality Limit (DML) shall be authorised to encircle schools or groups of dolphins with purse seines when fishing for yellowfin tunas in Convention area. CHAPTER IV Scientific observers Article 18 Scientific observers on longline vessels 1. Member States shall ensure that longline vessels flying their flag carry a scientific observer on board to cover at least 5 % of the fishing effort made by their vessels greater than 20 metres in length overall. 2. Scientific observers shall record the catches of targeted fish species, species composition and any other available biological information as well as any interactions with non-target species such as sea turtles, seabirds and sharks. 3. Scientific observers on board Union fishing vessels shall submit to the Member State authorities a report on these observations at the latest 15 days after the end of each fishing trip. That report shall be sent to the Commission in accordance with Article 25(5). Article 19 Scientific observers\u2019 safety at sea 1. This Article shall be without prejudice to obligations of observers and responsibilities of the master of the vessel set out in the Annex II to the Agreement. 2. The master of the vessel shall: (a) take all necessary measures to ensure that observers are able to carry out their duties in a competent and safe manner; (b) endeavour to ensure that observers alternate vessels between their assignments; (c) ensure that the vessel on which an observer is placed provide suitable food and lodging for the observer during the observer\u2019s deployment at the same level as the officers, where possible; (d) ensure that all necessary cooperation is extended to observers in order for them to carry out their duties safely, including providing access, as required, to the retained catch, and catch which is intended to be discarded. 3. Member States shall take measures to ensure the safety of observers and crew members in accordance with IATTC Resolution C-11-08 on improving observer safety at sea, as well as relevant Union and international labour standards, in particular Council Directive 89/391/EEC (15), Council Directive (EU) 2017/159 (16), the Work in Fishing Convention, 2007 of the International Labour Organisation (No 188) and the Violence and Harassment Convention, 2019 of the International Labour Organisation (No 190). 4. Member States shall ensure that observers fulfil the qualification criteria set out in the Annex II to the Agreement. 5. In the event that an observer dies, is missing or presumed fallen overboard, the master of the vessel shall: (a) ensure that the Union fishing vessel immediately ceases all fishing operations; (b) ensure that the Union fishing vessel immediately commences a search and rescue operation if the observer is missing or presumed fallen overboard, and searches for at least 72 hours, unless instructed by the flag Member State to continue searching; (c) immediately notify the flag Member State and the observer provider; (d) immediately alert other vessels in the vicinity by using all available means of communication; (e) cooperate fully in any search and rescue operation and, after such search and rescue operation has been terminated, order the vessel to the nearest port for further investigation, as agreed by the flag Member State and the observer provider; (f) provide the report on the incident to the observer provider and the authorities of the flag Member State; and (g) cooperate fully in any official investigations into the incident, and preserve any potential evidence and the personal effects and quarters of the deceased or missing observer. 6. In the event that an observer dies, the master of the vessel shall ensure that, to the extent practicable, the body is well preserved for the purposes of an autopsy and investigation. 7. In the event that an observer suffers from a serious illness or injury that threatens his or her life or long-term health or safety, the master of the vessel shall: (a) ensure that the Union fishing vessel immediately ceases fishing operations; (b) immediately notify the flag Member State and the observer provider; (c) take all reasonable actions to care for the observer and provide any medical treatment available and possible on board the vessel, and where appropriate seek external medical advice; (d) where directed by the observer provider, if not already directed by the flag Member State, facilitate the disembarkation and transport of the observer to a medical facility equipped to provide the required care as directed by the flag Member State or the observer provider, as soon as practicable; and (e) cooperate fully in any official investigations into the cause of the illness or injury. 8. Without prejudice to the obligations applicable to the master of the vessel, for the purposes of paragraphs 5 to 7, the flag Member State shall ensure that the appropriate Maritime Rescue Coordination Centre, observer provider, and the IATTC Secretariat are immediately notified and provided a report on actions undertaken. 9. In the event that there are reasonable grounds to believe an observer has been assaulted, intimidated, threatened, or harassed such that their health or safety is endangered and the observer or the observer provider requests that the flag Member State remove the observer from the Union fishing vessel, the master of that vessel shall: (a) immediately take action to preserve the safety of the observer and mitigate and resolve the situation on board; (b) immediately notify the flag Member State and the observer provider of the situation, including the status and location of the observer; (c) facilitate the safe disembarkation of the observer in a manner and place, as agreed by the flag Member State and the observer provider, that allows access to any needed medical treatment; and (d) cooperate fully in any official investigations into the incident. 10. In the event that there are reasonable grounds to believe that an observer has been assaulted, intimidated, threatened, or harassed such that their health or safety is endangered but neither the observer nor the observer provider requests that the observer be removed from the fishing vessel, the master of that vessel shall: (a) immediately take action to preserve the safety of the observer and mitigate and resolve the situation on board; (b) immediately notify the flag Member State and the observer provider of the situation; and (c) cooperate fully in any official investigations into the incident. 11. Where, after disembarkation from a fishing vessel of an observer, an observer provider identifies, such as during the course of debriefing the observer, a possible incident involving assault or harassment of the observer while on board the fishing vessel, the observer provider shall notify, in writing, the flag Member State and the IATTC Secretariat. 12. Upon receipt of the notification referred to in point (b) of paragraph 10, the flag Member State shall: (a) investigate the incident based on the information provided by the observer provider, prepare an incident report on this basis and take any appropriate action in response to the results of the investigation; (b) cooperate fully in any official investigation conducted by the observer provider, including providing the incident report of its investigation to the observer provider and appropriate authorities; and (c) notify the observer provider and the IATTC of the results of its investigation and any actions taken. 13. National observer providers shall: (a) immediately notify the flag Member State in the event that an observer dies, is missing or presumed fallen overboard in the course of observer duties; (b) cooperate fully in any search and rescue operation; (c) cooperate fully in any official investigations into any incident involving an observer; (d) facilitate the disembarkation and replacement of an observer in a situation involving the serious illness or injury of that observer as soon as possible; (e) facilitate the disembarkation of an observer in any situation involving the assault, intimidation, threats to, or harassment of that observer to such an extent that the observer wishes to be removed from the vessel, as soon as possible; and (f) provide the flag Member State with a copy of the observer report on alleged incidents involving assault or harassment of the observer upon request. 14. Relevant observer providers and Member States shall cooperate with each other\u2019s investigations, including providing their incident reports for any incidents referred to in paragraphs 5 to 11 to facilitate any investigations as appropriate. CHAPTER V Vessel requirements Article 20 Regional Vessel Register 1. Member States shall provide the Commission with the following information with respect to each vessel under its jurisdiction to be included in the Regional Vessel Register: (a) name of Union fishing vessel, registration number, previous names (if known), and port of registry; (b) a photograph of the vessel showing its registration number; (c) previous flag (if known and if any); (d) International Radio Call Sign (if any); (e) name and address of owner or owners; (f) date and place of building; (g) length, beam, and moulded depth; (h) freezer type and freezer capacity, in cubic metres; (i) number and capacity of fish holds, in cubic metres and, in the case of purse seine vessels, capacity breakdown by fish hold if possible; (j) name and address of operator(s) and manager(s) (if any); (k) type of vessel; (l) type of fishing method or methods; (m) gross tonnage; (n) power of main engine or engines; (o) the main target species; and (p) International Maritime Organization (IMO) number. 2. Each Member State shall promptly notify the Commission of any modifications to the information concerning elements listed in paragraph 1. The Commission shall forward that information to the IATTC Secretariat without delay. 3. Each Member State shall also promptly notify the Commission of: (a) any additions to the record; (b) any deletions from the record by reason of: (i) the voluntary relinquishment or non-renewal of the fishing authorisation by the owner or operator of the vessel; (ii) the withdrawal of the fishing authorisation issued to the vessel; (iii) the fact that the vessel is no longer entitled to fly its flag; (iv) the scrapping, decommissioning or loss of the vessel; and (c) any other deletion not listed in point (b). 4. Member States shall notify the Commission by 30 May each year of the Union fishing vessels on the Regional Vessel Register flying their flag that were actively fishing in the Convention area for species covered by the Convention from 1 January to 31 December of the previous year. The Commission shall forward that information to the IATTC Secretariat without delay. 5. The Commission shall request Member States to provide complete data for the vessels flying their flag in accordance with paragraph 1 if those Member States do not provide all the required information. Article 21 Sealed wells 1. A well that is sealed shall be physically sealed in a tamper-proof manner, and in such a way that it does not communicate with any other space on the vessel and that its use for any other storage is prevented. 2. Member States shall take the necessary measures to inspect and verify the wells sealed for the first time. 3. Any vessel with one or more of its wells sealed to reduce the well volume recorded on the Regional Vessel Register shall be required to carry an observer from the AIDCP on board. 4. It shall be possible to open a sealed well only in the event of an emergency. If a sealed well is opened at sea, the observer shall be present both when the well is opened and when it is resealed. 5. All refrigeration equipment in the sealed well shall be rendered inoperative. 6. The master of the vessel shall notify observers of any sealed wells on-board. Observers shall report to the IATTC Secretariat any instances of sealed wells being used for storing fish. CHAPTER VI Data and statistical document Article 22 Provision of data 1. Member States shall ensure that all pertinent catch information is provided to the Commission on an annual basis, for all of their vessels fishing for species under the purview of the Convention. 2. Member States shall provide the data, by species and fishing gear, where practical, via vessel logbooks and unloading records, and otherwise in aggregated form as in the table set out in IATTC Resolution C-03-05, with Level 3 catch and effort data as a minimum requirement, and, whenever possible, Levels 1 and 2 catch and effort data and length-frequency data. 3. The aggregated data table referred to in paragraph 2 for each year shall be provided to the Commission by 31 May of the following year. The Commission shall forward that information to the IATTC Secretariat by 30 June. Article 23 Bigeye tuna statistical document 1. All bigeye tunas imported into the territory of the Union shall be accompanied by the bigeye tuna statistical document or the IATTC bigeye tuna re-export certificate, as appropriate, established by the IATTC (17). Bigeye tuna caught by purse seiners and bait boats and destined principally for further processing by tuna canneries shall not be subject to that statistical document requirement. 2. The IATTC bigeye tuna statistical document shall be validated by the authorities of the flag Member State of the vessel that harvested the tuna. The IATTC bigeye tuna re-export certificate shall be validated by the authorities of the Member State that re-exported the tuna. 3. The Member States that import bigeye tuna shall report to the Commission the trade data collected by their authorities each year by 1 April for the period of 1 July to 31 December of the preceding year and by 1 October for the period of 1 January to 30 June of the current year. The Commission shall forward that information to the IATTC Secretariat without delay. 4. Member States that export bigeye tuna shall examine the trade data upon receiving the import data referred to in paragraph 3 and shall report the results to the Commission. The Commission shall forward that information to the IATTC Secretariat without delay. 5. Member States shall validate statistical documents involving a transhipment at port undertaken by longline vessels flying their flag where the transhipment was conducted in accordance with this Regulation and on the basis of the information obtained through the IATTC observer programme. 6. Member States that validate a statistical document involving transhipments undertaken by a longline vessel flying their flag shall ensure that the information is consistent with the catches reported by each longline vessel. 7. All tunas and tuna-like species and sharks landed in, or imported into, the Union, either unprocessed or after having been processed on board, and which are transhipped, shall be accompanied by the IATTC transhipment declaration form until the first sale has taken place. CHAPTER VII Final provisions Article 24 Overlap area 1. Union fishing vessels listed exclusively in the IATTC register shall apply the conservation and management measures of the IATTC when fishing in the overlap area. 2. In the case of vessels listed in the vessel registers of both the WCPFC and the IATTC, prior to fishing in the overlap area, flag Member States shall notify the Commission under which of the two conservation and management measures adopted by those organisations the vessels flying their flag shall operate when fishing in the overlap area. The notification shall be valid for a period of not less than three years. Article 25 Reporting 1. Member States shall submit to the Commission, by 15 June of each year for the preceding year, a national report on their compliance scheme and actions taken to implement IATTC measures, including any controls they have imposed on their fleets and any monitoring, control and compliance measures they have established to ensure compliance with such controls. 2. Member States shall report annually by 15 April for the preceding year data for catches, effort by gear type, landing and trade of sharks by species, data regarding whitetip sharks referred to in Article 8(3), mobulid rays referred to in Article 9(4) and silky sharks referred to in Article 10. The Commission shall forward those data to the IATTC Secretariat by 1 May. 3. Member States shall report annually by 15 June for the preceding year on the implementation of Article 15 and interactions with seabirds during fishing activities managed under the Convention, including by-catches of seabirds, details of seabird species, and all relevant information available from observers and other monitoring programmes. The Commission shall forward that information to the IATTC Secretariat by 30 June. 4. Member States shall report annually by 15 June for the preceding year on the implementation of Article 16 and the Guidelines of the Food and Agriculture Organisation of the United Nations to Reduce Sea Turtle Mortality in Fishing Operations (2009) (18) for turtles, including information collected on interaction with turtles during fishing activities managed under the Convention. The Commission shall forward that information to the IATTC Secretariat by 30 June. 5. Member States shall submit a scientific observer report for longline vessels referred to in Article 18(3) by 15 March for the preceding year. The Commission shall forward that information to the IATTC Secretariat by 30 March. Article 26 Alleged non-compliance reported by the IATTC 1. If the Commission receives from the IATTC Secretariat any information indicating a suspected non-compliance with the Convention or Resolutions by a Member State or by Union fishing vessels, the Commission shall transmit that information to the Member State concerned without delay. 2. The Member State shall launch an investigation in relation to the allegations of non-compliance and shall provide the Commission with the findings of such investigation and any actions taken to address any non-compliance concerns at least 75 days in advance of the annual meeting of the Committee for the Review of Implementation of Measures (\u2018Compliance Committee\u2019). 3. The Commission shall forward that information to the IATTC Secretariat at least 60 days in advance of the Compliance Committee meeting. Article 27 Confidentiality In addition to the obligations laid down in Articles 112 and 113 of Regulation (EC) No 1224/2009, Member States, masters of vessels and observers shall ensure confidential treatment of electronic reports and messages transmitted to and received from the IATTC Secretariat pursuant to Article 10(2), Article 19(5) and (8) and Article 21(6) of this Regulation. Article 28 Empowerment for amendments 1. The Commission is empowered to adopt delegated acts amending this Regulation, in accordance with Article 29, to adapt it to measures adopted by the IATTC that bind the Union and its Member States concerning: (a) the transhipment declaration form referred to in point (16) of Article 3; (b) the reference to depiction of shark lines in point (19) of Article 3; (c) closure periods referred to in point (a) of Article 4(1) and in Article 4(5); (d) FADs reporting timelines provided for in Article 6(3); (e) information to be collected when fishing with FADs listed by Article 6(4); (f) provisions concerning design and deployment of FAD provided for in Article 6(6); (g) the data collection deadline referred to in Article 14(1); (h) areas and mitigation measures for the protection of seabirds of Article 15(1) and (2); (i) scientific observer coverage of 5 % referred to in Article 18(1); (j) information related to the Regional Vessel Register listed in Article 20(1); (k) the reference to table for provision of data for the logbooks and unloading records provided for in Article 22(2); (l) the reference to the bigeye tuna statistical document in Article 23(1); (m) reporting deadlines provided for in Article 25; (n) the reference to turtle mortality guidelines in Article 25(4); (o) the Annex to this Regulation. 2. Amendments in accordance with paragraph 1 shall be strictly limited to the implementation of amendments or new Resolutions into Union law. Article 29 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 28 shall be conferred on the Commission for a period of five years from 15 February 2021. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 28 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 28 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 30 Amendments to Regulation (EC) No 520/2007 Article 3(3), Article 4(3) and Title IV of Regulation (EC) No 520/2007 are deleted. Article 31 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 January 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) Opinion of 2 December 2020 (not yet published in the Official Journal). (2) Position of the European Parliament of 15 December 2020 (not yet published in the Official Journal) and decision of the Council of 13 January 2021. (3) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (4) Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 1). (5) Council Decision 98/414/EC of 8 June 1998 on the ratification by the European Community of the Agreement for the implementing of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling stocks and highly migratory fish stocks (OJ L 189, 3.7.1998, p. 14). (6) Council Decision 2006/539/EC of 22 May 2006 on the conclusion, on behalf of the European Community of the Convention for the strengthening of the Inter-American Tropical Tuna Commission established by the 1949 Convention between the United States of America and the Republic of Costa Rica (OJ L 224, 16.8.2006, p. 22). (7) Council Decision 2005/938/EC of 8 December 2005 on the approval on behalf of the European Community of the Agreement on the International Dolphin Conservation Programme (OJ L 348, 30.12.2005, p. 26). (8) Council Regulation (EC) No 520/2007 of 7 May 2007 laying down technical measures for the conservation of certain stocks of highly migratory species and repealing Regulation (EC) No 973/2001 (OJ L 123, 12.5.2007, p. 3). (9) OJ L 123, 12.5.2016, p. 1. (10) Regulation (EU) 2017/2403 of the European Parliament and of the Council of 12 December 2017 on the sustainable management of external fishing fleets, and repealing Council Regulation (EC) No 1006/2008 (OJ L 347, 28.12.2017, p. 81). (11) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (12) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (13) Council Regulation (EC) No 1185/2003 of 26 June 2003 on the removal of fins of sharks on board vessels (OJ L 167, 4.7.2003, p. 1). (14) Council Decision 2005/75/EC of 26 April 2004 on the accession of the Community to the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (OJ L 32, 4.2.2005, p. 1). (15) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1). (16) Council Directive (EU) 2017/159 of 19 December 2016 implementing the Agreement concerning the implementation of the Work in Fishing Convention, 2007 of the International Labour Organisation, concluded on 21 May 2012 between the General Confederation of Agricultural Cooperatives in the European Union (Cogeca), the European Transport Workers\u2019 Federation (ETF) and the Association of National Organisations of Fishing Enterprises in the European Union (Europ\u00eache) (OJ L 25, 31.1.2017, p. 12). (17) Annexes 1 and 2 to Resolution C-03-01 for, respectively, the bigeye tuna statistical document and the bigeye tuna re-export certificate. (18) http://www.fao.org/docrep/012/i0725e/i0725e.pdf ANNEX Table 1: Mitigation measures Column A Column B Side-setting with bird curtains and weighted branch lines Tori line Night setting with minimum deck lighting Weighted branch lines Tori line Blue-dyed bait Weighted branch lines Deep-setting line shooter Underwater setting chute Management of offal discharge", "summary": "Management, conservation and control measures in the Inter-American Tropical Tuna Convention area Management, conservation and control measures in the Inter-American Tropical Tuna Convention area SUMMARY OF: Regulation (EU) 2021/56 laying down management, conservation and control measures applicable in the Inter-American Tropical Tuna Convention area and amending Council Regulation (EC) No 520/2007 WHAT IS THE AIM OF THE REGULATION? The regulation transposes into EU law the management, conservation and control measures adopted by the Inter-American Tropical Tuna Commission (IATTC) concerning stocks of tunas, and other species of fish in the same ecosystem. The Convention covers a defined area of the eastern Pacific Ocean. KEY POINTS Conservation and management Time closures: fishing is closed to purse seine* vessels for tropical tunas (bigeye tuna, yellowfin tuna and skipjack tuna) for 2 periods each year. Each EU Member State involved in the fishery stipulates by 15 June which of the two closure periods \u2014 from 29 July to 8 October, or from 9 November to 19 January \u2014 will apply to their vessels. Area closures: fishing for tropical tunas within the area of 96\u00b0 and 110\u00b0W and between 4\u00b0N and 3\u00b0S is closed from 9 October to 8 November. Deploying fishing gear within 1 nautical mile of, or interacting with, an anchored data buoy* in the Convention area is prohibited. Active fish-aggregating devices* (FADs) are limited to 450 per purse seine vessel. Member Statesshall report daily information on all active FADs to the European Commission submitted with a time delay of at least 60 days, but with not more than 90 days between each report. Operators of EU fishing vessels must collect and report any interaction with FADs. All transhipments of IATTC species in the Convention area shall take place in port. Protecting marine species The following species shall not be retained on board, transhipped, landed, stored, or sold, and must be safely released: oceanic whitetip sharks;mobulid rays (which includes Manta rays and Mobula rays);silky sharks (where caught by purse seine). EU fishing vessels shall not set a purse seine net on a school of tunas where a whale shark is present, and incidents should be reported. They shall promptly release sharks (whether alive or dead) as soon as possible without compromising human safety. EU longline fishing vessels shall not use shark lines. Catch data for silky and hammerhead sharks shall be reported to the IATTC. Sea turtles shall be promptly released, in a way that causes the least harm and without compromising human safety of any persons. At least one crew member must be trained in techniques for handling and release of sea turtles to improve survival after release. There are also measures aimed at protecting seabirds (restrictions on using longlines), and dolphins (authorised vessels only, and restrictions on using purse seines when fishing for yellowfin tunas). Scientific observers on long-liners Member States must ensure that longline vessels carry a scientific observer on board, to cover at least 5% of the fishing effort made by vessels longer than 20 metres, who records catches of targeted fish species, species composition and any other available biological information as well as any interactions with non-target species such as sea turtles, seabirds and sharks. The regulation includes detailed rules to assure observer safety. Vessel requirements Member States shall provide detailed information on each fishing vessel under their jurisdiction fishing in the Convention area for the IATTC Regional Vessel Register. A well (as space on board a vessel to carry live fish) that is sealed must be physically sealed in a tamper-proof manner so that it is not connected with any other space on the vessel and cannot be used for any other storage. Observers must report to the IATTC any instances of sealed wells being used for storing fish. Catch data Catch data must be reported by Member States to the Commission annually for species covered by the Convention, with special rules for reporting on bigeye tuna caught by purse seiners and bait boats. FROM WHEN DOES THE REGULATION APPLY? It has applied since 15 February 2021. BACKGROUND The EU concluded the Convention in 2006 as a contracting party to the United Nations Convention on the Law of the Sea (see summary). See also: Regional fisheries management organisations (RFMOs) (European Commission). KEY TERMS Purse seine: any encircling net, the bottom of which is drawn together by a purse line at the bottom of the net, which passes through a series of rings along the ground rope, enabling the net to be pursed and closed. Data buoys: floating devices, either drifting or anchored, that are deployed by governmental or recognised scientific organisations or entities to electronically collect environmental data, not in support of fishing activities, and which have been notified to the IATTC Secretariat. Fish-aggregating device (FAD): anchored, drifting, floating or submerged objects deployed or tracked by vessels, including through the use of radio or satellite buoys, for the purpose of aggregating target tuna species for purse seine fishing operations. MAIN DOCUMENT Regulation (EU) 2021/56 of the European Parliament and of the Council of 20 January 2021 laying down management, conservation and control measures applicable in the Inter-American Tropical Tuna Convention area and amending Council Regulation (EC) No 520/2007 (OJ L 24, 26.1.2021, pp. 1-18) RELATED DOCUMENTS Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1-50) Successive amendments to Regulation (EC) No 1224/2009 have been incorporated into the original text. This consolidated version is of documentary value only. Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, pp. 1-32) See consolidated version. Council Regulation (EC) No 520/2007 of 7 May 2007 laying down technical measures for the conservation of certain stocks of highly migratory species and repealing Regulation (EC) No 973/2001 (OJ L 123, 12.5.2007, pp. 3-13) See consolidated version. Council Decision 2006/539/EC of 22 May 2006 on the conclusion, on behalf of the European Community of the Convention for the Strengthening of the Inter-American Tropical Tuna Commission established by the 1949 Convention between the United States of America and the Republic of Costa Rica (OJ L 224, 16.8.2006, pp. 22-23) Convention for the strengthening of the Inter-American Tropical Tuna Commission established by the 1949 Convention between the United States of America and the Republic of Costa Rica (Antigua Convention) (OJ L 224, 16.8.2006, pp. 24-42) Council Decision 2005/26/EC of 25 October 2004 on the signing, on behalf of the European Community, of the Convention for the strengthening of the Inter-American Tropical Tuna Commission established by the 1949 Convention between the United States of America and the Republic of Costa Rica (\u2018Antigua Convention\u2019) (OJ L 15, 19.1.2005, p. 9) Council Regulation (EC) No 1185/2003 of 26 June 2003 on the removal of fins of sharks on board vessels (OJ L 167, 4.7.2003, pp. 1-3) See consolidated version. Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, pp. 1-2) United Nations Convention on the Law of the Sea and of the Agreement on the implementation of Part XI thereof (Montego Bay Convention) (OJ L 179, 23.6.1998, pp. 3-134) last update 09.04.2021"}
{"article": "12.5.2016 EN Official Journal of the European Union L 123/1 INTERINSTITUTIONAL AGREEMENT BETWEEN THE EUROPEAN PARLIAMENT, THE COUNCIL OF THE EUROPEAN UNION AND THE EUROPEAN COMMISSION ON BETTER LAW-MAKING INTERINSTITUTIONAL AGREEMENT of 13 April 2016 on Better Law-Making THE EUROPEAN PARLIAMENT, THE COUNCIL OF THE EUROPEAN UNION AND THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 295 thereof, Whereas: (1) The European Parliament, the Council and the Commission (\"the three Institutions\") are committed to sincere and transparent cooperation throughout the entire legislative cycle. In this context, they recall the equality of both co-legislators as enshrined in the Treaties. (2) The three Institutions recognise their joint responsibility in delivering high-quality Union legislation and in ensuring that such legislation focuses on areas where it has the greatest added value for European citizens, is as efficient and effective as possible in delivering the common policy objectives of the Union, is as simple and as clear as possible, avoids overregulation and administrative burdens for citizens, administrations and businesses, especially small and medium-sized enterprises (\"SMEs\"), and is designed with a view to facilitating its transposition and practical application and to strengthening the competitiveness and sustainability of the Union economy. (3) The three Institutions recall the Union obligation to legislate only where and to the extent necessary, in accordance with Article 5 of the Treaty on European Union on the principles of subsidiarity and proportionality. (4) The three Institutions reiterate the role and responsibility of national Parliaments as laid down in the Treaties, in Protocol No 1 on the role of National Parliaments in the European Union annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community and in Protocol No 2 on the application of the principles of subsidiarity and proportionality, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union. (5) The three Institutions agree that the analysis of the potential \"European added value\" of any proposed Union action, as well as an assessment of the \"cost of non-Europe\" in the absence of action at Union level, should be fully taken into account when setting the legislative agenda. (6) The three Institutions consider that public and stakeholder consultation, ex-post evaluation of existing legislation and impact assessments of new initiatives will help achieve the objective of Better Law-Making. (7) With a view to facilitating the negotiations in the framework of the ordinary legislative procedure and improving the application of Articles 290 and 291 of the Treaty on the Functioning of the European Union, this Agreement establishes the principles in accordance with which the Commission will gather all necessary expertise prior to adopting delegated acts. (8) The three Institutions affirm that the goals of simplifying Union legislation and reducing the regulatory burden should be pursued without prejudice to the achievement of the policy objectives of the Union, as specified in the Treaties, or to safeguarding the integrity of the internal market. (9) This Agreement complements the following agreements and declarations on Better Law-Making, to which the three Institutions remain fully committed: \u2014 Interinstitutional Agreement of 20 December 1994 \u2013Accelerated working method for official codification of legislative texts (1); \u2014 Interinstitutional Agreement of 22 December 1998 on common guidelines for the quality of drafting of Community legislation (2); \u2014 Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts (3); \u2014 Joint Declaration of 13 June 2007 on practical arrangements for the codecision procedure (4); \u2014 Joint Political Declaration of 27 October 2011 of the European Parliament, the Council and the Commission on explanatory documents (5), HAVE AGREED AS FOLLOWS: I. COMMON COMMITMENTS AND OBJECTIVES 1. The three Institutions hereby agree to pursue Better Law-Making by means of a series of initiatives and procedures, as set out in this Agreement. 2. In exercising their powers and in compliance with the procedures laid down in the Treaties, and recalling the importance which they attach to the Community method, the three Institutions agree to observe general principles of Union law, such as democratic legitimacy, subsidiarity and proportionality, and legal certainty. They further agree to promote simplicity, clarity and consistency in the drafting of Union legislation and to promote the utmost transparency of the legislative process. 3. The three Institutions agree that Union legislation should be comprehensible and clear, allow citizens, administrations and businesses to easily understand their rights and obligations, include appropriate reporting, monitoring and evaluation requirements, avoid overregulation and administrative burdens, and be practical to implement. II. PROGRAMMING 4. The three Institutions agree to reinforce the Union's annual and multiannual programming in line with Article 17(1) of the Treaty on European Union, which entrusts the Commission with the task of initiating annual and multiannual programming. Multiannual programming 5. Upon the appointment of a new Commission, in order to facilitate longer-term planning, the three Institutions will exchange views on the principal policy objectives and priorities of the three Institutions for the new term as well as, wherever possible, on indicative timing. The three Institutions will, on the Commission's initiative and as appropriate, draw up joint conclusions to be signed by the Presidents of the three Institutions. The three Institutions will, on the Commission's initiative, carry out a mid-term review of those joint conclusions and adjust them as appropriate. Annual programming \u2013 Commission Work Programme and interinstitutional programming 6. The Commission will engage in a dialogue with the European Parliament and the Council respectively, both before and after the adoption of its annual Work Programme (\"the Commission Work Programme\"). That dialogue will encompass the following: (a) early bilateral exchanges of views on initiatives for the upcoming year will take place in advance of the submission of a written contribution from the President of the Commission and its First Vice-President setting out in appropriate detail items of major political importance for the following year and containing indications with regard to intended withdrawals of Commission proposals (\"letter of intent\"); (b) following the debate on the State of the Union, and before the adoption of the Commission Work Programme, the European Parliament and the Council will have an exchange of views with the Commission on the basis of the letter of intent; (c) an exchange of views will take place between the three Institutions on the adopted Commission Work Programme, pursuant to paragraph 7. The Commission will duly take account of the views expressed by the European Parliament and the Council at each stage of the dialogue, including their requests for initiatives. 7. Following the adoption of the Commission Work Programme and drawing on it, the three Institutions will exchange views on initiatives for the coming year and agree on a joint declaration on annual interinstitutional programming (\"joint declaration\"), to be signed by the Presidents of the three Institutions. The joint declaration will set out broad objectives and priorities for the following year and will identify items of major political importance which, without prejudice to the powers conferred by the Treaties on the co-legislators, should receive priority treatment in the legislative process. The three Institutions will monitor, on a regular basis throughout the year, the implementation of the joint declaration. To that end, the three Institutions will participate in debates on the implementation of the joint declaration in the European Parliament and/or the Council during the spring of the year in question. 8. The Commission Work Programme will include major legislative and non-legislative proposals for the following year, including repeals, recasts, simplifications and withdrawals. For each item, the Commission Work Programme will indicate the following, as far as available: the intended legal basis; the type of legal act; an indicative timetable for adoption by the Commission; and any other relevant procedural information, including information concerning impact assessment and evaluation work. 9. In accordance with the principles of sincere cooperation and of institutional balance, when the Commission intends to withdraw a legislative proposal, whether or not such withdrawal is to be followed by a revised proposal, it will provide the reasons for such withdrawal, and, if applicable, an indication of the intended subsequent steps along with a precise timetable, and will conduct proper interinstitutional consultations on that basis. The Commission will take due account of, and respond to, the co-legislators' positions. 10. The Commission will give prompt and detailed consideration to requests for proposals for Union acts made by the European Parliament or the Council pursuant to Article 225 or Article 241 of the Treaty on the Functioning of the European Union respectively. The Commission will reply to such requests within three months, stating the follow-up it intends to give to them by adopting a specific communication. If the Commission decides not to submit a proposal in response to such a request, it will inform the institution concerned of the detailed reasons, and will provide, where appropriate, an analysis of possible alternatives and respond to any issues raised by the co-legislators in relation to analyses concerning 'European added value' and concerning the \"cost of non-Europe\". If so requested, the Commission will present its reply in the European Parliament or in the Council. 11. The Commission will provide regular updates on its planning throughout the year and give reasons for any delay in the presentation of the proposals included in its Work Programme. The Commission will regularly report to the European Parliament and to the Council on the implementation of its Work Programme for the year in question. III. TOOLS FOR BETTER LAW-MAKING Impact assessment 12. The three Institutions agree on the positive contribution of impact assessments in improving the quality of Union legislation. Impact assessments are a tool to help the three Institutions reach well-informed decisions and not a substitute for political decisions within the democratic decision-making process. Impact assessments must not lead to undue delays in the law-making process or prejudice the co-legislators' capacity to propose amendments. Impact assessments should cover the existence, scale and consequences of a problem and the question whether or not Union action is needed. They should map out alternative solutions and, where possible, potential short and long-term costs and benefits, assessing the economic, environmental and social impacts in an integrated and balanced way and using both qualitative and quantitative analyses. The principles of subsidiarity and proportionality should be fully respected, as should fundamental rights. Impact assessments should also address, whenever possible, the \"cost of non-Europe\" and the impact on competitiveness and the administrative burdens of the different options, having particular regard to SMEs (\"Think Small First\"), digital aspects and territorial impact. Impact assessments should be based on accurate, objective and complete information and should be proportionate as regards their scope and focus. 13. The Commission will carry out impact assessments of its legislative and non-legislative initiatives, delegated acts and implementing measures which are expected to have significant economic, environmental or social impacts. The initiatives included in the Commission Work Programme or in the joint declaration will, as a general rule, be accompanied by an impact assessment. In its own impact assessment process, the Commission will consult as widely as possible. The Commission's Regulatory Scrutiny Board will carry out an objective quality check of its impact assessments. The final results of the impact assessments will be made available to the European Parliament, the Council and national Parliaments, and will be made public along with the opinion(s) of the Regulatory Scrutiny Board at the time of adoption of the Commission initiative. 14. The European Parliament and the Council, upon considering Commission legislative proposals, will take full account of the Commission's impact assessments. To that end, impact assessments shall be presented in such a way as to facilitate the consideration by the European Parliament and the Council of the choices made by the Commission. 15. The European Parliament and the Council will, when they consider this to be appropriate and necessary for the legislative process, carry out impact assessments in relation to their substantial amendments to the Commission's proposal. The European Parliament and the Council will, as a general rule, take the Commission's impact assessment as the starting point for their further work. The definition of a 'substantial' amendment should be for the respective Institution to determine. 16. The Commission may, on its own initiative or upon invitation by the European Parliament or the Council, complement its own impact assessment or undertake other analytical work it considers necessary. When doing so, the Commission will take into account all available information, the stage reached in the legislative process and the need to avoid undue delays in that process. The co-legislators will take full account of any additional elements provided by the Commission in that context. 17. Each of the three Institutions is responsible for determining how to organise its impact assessment work, including internal organisational resources and quality control. They will, on a regular basis, cooperate by exchanging information on best practice and methodologies relating to impact assessments, enabling each Institution to further improve its own methodology and procedures and the coherence of the overall impact assessment work. 18. The Commission's initial impact assessment and any additional impact assessment work conducted during the legislative process by the Institutions will be made public by the end of the legislative process and, taken together, can be used as the basis for evaluation. Public and stakeholder consultation and feedback 19. Public and stakeholder consultation is integral to well-informed decision-making and to improving the quality of law-making. Without prejudice to the specific arrangements applying to the Commission's proposals under Article 155(2) of the Treaty on the Functioning of the European Union, the Commission will, before adopting a proposal, conduct public consultations in an open and transparent way, ensuring that the modalities and time-limits of those public consultations allow for the widest possible participation. The Commission will in particular encourage the direct participation of SMEs and other end-users in the consultations. This will include public internet-based consultations. The results of public and stakeholder consultations shall be communicated without delay to both co-legislators and made public. Ex-post evaluation of existing legislation 20. The three Institutions confirm the importance of the greatest possible consistency and coherence in organising their work to evaluate the performance of Union legislation, including related public and stakeholder consultations. 21. The Commission will inform the European Parliament and the Council of its multiannual planning of evaluations of existing legislation and will, to the extent possible, include in that planning their requests for in-depth evaluation of specific policy areas or legal acts. The Commission's evaluation planning will respect the timing for reports and reviews set out in Union legislation. 22. In the context of the legislative cycle, evaluations of existing legislation and policy, based on efficiency, effectiveness, relevance, coherence and value added, should provide the basis for impact assessments of options for further action. To support these processes, the three Institutions agree to, as appropriate, establish reporting, monitoring and evaluation requirements in legislation, while avoiding overregulation and administrative burdens, in particular on Member States. Where appropriate, such requirements can include measurable indicators as a basis on which to collect evidence of the effects of legislation on the ground. 23. The three Institutions agree to systematically consider the use of review clauses in legislation and to take account of the time needed for implementation and for gathering evidence on results and impacts. The three Institutions will consider whether to limit the application of certain legislation to a fixed period of time (\"sunset clause\"). 24. The three Institutions shall inform each other in good time before adopting or revising their guidelines concerning their tools for Better Law-Making (public and stakeholder consultations, impact assessments and ex-post evaluations). IV. LEGISLATIVE INSTRUMENTS 25. The Commission shall provide, in relation to each proposal, an explanation and justification to the European Parliament and to the Council regarding its choice of legal basis and type of legal act in the explanatory memorandum accompanying the proposal. The Commission should take due account of the difference in nature and effects between regulations and directives. The Commission shall also explain in its explanatory memoranda how the measures proposed are justified in the light of the principles of subsidiarity and proportionality and how they are compatible with fundamental rights. The Commission shall, in addition, give an account of both the scope and the results of any public and stakeholder consultation, impact assessment and ex-post evaluation of existing legislation that it has undertaken. If a modification of the legal basis entailing a change from the ordinary legislative procedure to a special legislative procedure or a non-legislative procedure is envisaged, the three Institutions will exchange views thereon. The three Institutions agree that the choice of legal basis is a legal determination that must be made on objective grounds which are amenable to judicial review. The Commission shall continue to fully play its institutional role to ensure that the Treaties and the case-law of the Court of Justice of the European Union are respected. V. DELEGATED AND IMPLEMENTING ACTS 26. The three Institutions underline the important role played by delegated and implementing acts in Union law. Used in an efficient, transparent manner and in justified cases, they are an integral tool for Better Law-Making, contributing to simple, up-to-date legislation and its efficient, swift implementation. It is the competence of the legislator to decide whether and to what extent to use delegated or implementing acts, within the limits of the Treaties. 27. The three Institutions acknowledge the need for the alignment of all existing legislation to the legal framework introduced by the Lisbon Treaty, and in particular the need to give high priority to the prompt alignment of all basic acts which still refer to the regulatory procedure with scrutiny. The Commission will propose that latter alignment by the end of 2016. 28. The three Institutions have agreed on a Common Understanding on Delegated Acts and on the related standard clauses (\"the Common Understanding\"), annexed hereto. In accordance with the Common Understanding and with a view to enhancing transparency and consultation, the Commission commits to gathering, prior to the adoption of delegated acts, all necessary expertise, including through the consultation of Member States' experts and through public consultations. Moreover, and whenever broader expertise is needed in the early preparation of draft implementing acts, the Commission will make use of expert groups, consult targeted stakeholders and carry out public consultations, as appropriate. To ensure equal access to all information, the European Parliament and Council shall receive all documents at the same time as Member States' experts. Experts from the European Parliament and from the Council shall systematically have access to the meetings of Commission expert groups to which Member States' experts are invited and which concern the preparation of delegated acts. The Commission may be invited to meetings in the European Parliament or the Council in order to have a further exchange of views on the preparation of delegated acts. The three Institutions will enter into negotiations without undue delay after the entry into force of this Agreement, with a view to supplementing the Common Understanding by providing for non-binding criteria for the application of Articles 290 and 291 of the Treaty on the Functioning of the European Union. 29. The three Institutions commit to set up, at the latest by the end of 2017 and in close cooperation, a joint functional register of delegated acts, providing information in a well-structured and user-friendly way, in order to enhance transparency, facilitate planning and enable traceability of all the different stages in the lifecycle of a delegated act. 30. As regards the Commission's exercise of implementing powers, the three Institutions agree to refrain from adding, in Union legislation, procedural requirements which would alter the mechanisms for control set out in Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). Committees carrying out their tasks under the procedure set up under that Regulation should not, in that capacity, be called upon to exercise other functions. 31. On condition that the Commission provides objective justifications based on the substantive link between two or more empowerments contained in a single legislative act, and unless the legislative act provides otherwise, empowerments may be bundled. Consultations in the preparation of delegated acts also serve to indicate which empowerments are considered to be substantively linked. In such cases, any objection by the European Parliament or the Council will indicate clearly to which empowerment it specifically relates. VI. TRANSPARENCY AND COORDINATION OF THE LEGISLATIVE PROCESS 32. The three Institutions acknowledge that the ordinary legislative procedure has developed on the basis of regular contacts at all stages of the procedure. They remain committed to further improving the work done under the ordinary legislative procedure in line with the principles of sincere cooperation, transparency, accountability and efficiency. The three Institutions agree in particular that the European Parliament and the Council, as the co-legislators, are to exercise their powers on an equal footing. The Commission shall carry out its role as facilitator by treating the two branches of the legislative authority equally, in full respect of the roles assigned by the Treaties to the three Institutions. 33. The three Institutions will keep each other regularly informed throughout the legislative process about their work, about on-going negotiations among them and about any stakeholder feedback that they may receive, via appropriate procedures, including dialogue between them. 34. The European Parliament and the Council, in their capacity as co-legislators, agree on the importance of maintaining close contacts already in advance of interinstitutional negotiations, so as to achieve a better mutual understanding of their respective positions. To that end, in the context of the legislative process, they will facilitate mutual exchange of views and information, including by inviting representatives of the other institutions to informal exchanges of views on a regular basis. 35. The European Parliament and the Council will, in the interest of efficiency, ensure a better synchronisation of their treatment of legislative proposals. In particular, the European Parliament and the Council will compare indicative timetables for the various stages leading to the final adoption of each legislative proposal. 36. Where appropriate, the three Institutions may agree to coordinate efforts to accelerate the legislative process while ensuring that the prerogatives of the co-legislators are respected and that the quality of legislation is preserved. 37. The three Institutions agree that the provision of information to national Parliaments must allow the latter to exercise fully their prerogatives under the Treaties. 38. The three Institutions will ensure the transparency of legislative procedures, on the basis of relevant legislation and case-law, including an appropriate handling of trilateral negotiations. The three Institutions will improve communication to the public during the whole legislative cycle and in particular will announce jointly the successful outcome of the legislative process in the ordinary legislative procedure once they have reached agreement, namely through joint press conferences or any other means considered appropriate. 39. In order to facilitate traceability of the various steps in the legislative process, the three Institutions undertake to identify, by 31 December 2016, ways of further developing platforms and tools to that end, with a view to establishing a dedicated joint database on the state of play of legislative files. 40. The three Institutions acknowledge the importance of ensuring that each Institution can exercise its rights and fulfil its obligations enshrined in the Treaties as interpreted by the Court of Justice of the European Union regarding the negotiation and conclusion of international agreements. The three Institutions commit to meet within six months after the entry into force of this Agreement in order to negotiate improved practical arrangements for cooperation and information-sharing within the framework of the Treaties, as interpreted by the Court of Justice of the European Union. VII. IMPLEMENTATION AND APPLICATION OF UNION LEGISLATION 41. The three Institutions agree on the importance of a more structured cooperation among them to assess the application and effectiveness of Union law with a view to its improvement through future legislation. 42. The three Institutions stress the need for the swift and correct application of Union legislation in the Member States. The time limit for transposition of directives will be as short as possible and, generally, will not exceed two years. 43. The three Institutions call upon the Member States, when they adopt measures to transpose or implement Union legislation or to ensure the implementation of the Union budget, to communicate clearly to their public on those measures. When, in the context of transposing directives into national law, Member States choose to add elements that are in no way related to that Union legislation, such additions should be made identifiable either through the transposing act(s) or through associated documents. 44. The three Institutions call upon the Member States to cooperate with the Commission in obtaining information and data needed to monitor and evaluate the implementation of Union law. The three Institutions recall and stress the importance of the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (7) and of the Joint Political Declaration of 27 October 2011 of the European Parliament, the Council and the Commission on explanatory documents, regarding explanatory documents which accompany the notification of transposition measures. 45. The Commission will continue to report annually to the European Parliament and the Council on the application of Union legislation. The Commission's report includes, where relevant, reference to the information mentioned in paragraph 43. The Commission may provide further information on the state of implementation of a given legal act. VIII. SIMPLIFICATION 46. The three Institutions confirm their commitment to using the legislative technique of recasting for the modification of existing legislation more frequently and in full respect of the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts. Where recasting is not appropriate, the Commission will submit a proposal in accordance with the Interinstitutional Agreement of 20 December 1994 \u2013Accelerated working method for official codification of legislative texts as soon as possible after the adoption of an amending act. If the Commission does not submit such a proposal, it shall state the reasons for not doing so. 47. The three Institutions commit to promoting the most efficient regulatory instruments, such as harmonisation and mutual recognition, in order to avoid overregulation and administrative burdens and fulfil the objectives of the Treaties. 48. The three Institutions agree to cooperate in order to update and simplify legislation and to avoid overregulation and administrative burdens for citizens, administrations and businesses, including SMEs, while ensuring that the objectives of the legislation are met. In this context, the three Institutions agree to exchange views on this matter prior to finalisation of the Commission Work Programme. By way of contribution to its regulatory fitness and performance programme (REFIT), the Commission undertakes to present annually an overview, including an annual burden survey, of the results of the Union's efforts to simplify legislation and to avoid overregulation and reduce administrative burdens. Based on the Institutions' impact assessment and evaluation work and input from Member States and stakeholders, and while taking into account the costs and benefits of Union regulation, the Commission will, wherever possible, quantify the regulatory burden reduction or savings potential of individual proposals or legal acts. The Commission will also assess the feasibility of establishing, in REFIT, objectives for the reduction of burdens in specific sectors. IX. IMPLEMENTATION AND MONITORING OF THIS AGREEMENT 49. The three Institutions will take the necessary steps to ensure that they have the means and resources required for the proper implementation of this Agreement. 50. The three Institutions will monitor the implementation of this Agreement jointly and regularly, at both the political level through annual discussions and the technical level in the Interinstitutional Coordination Group. X. FINAL PROVISIONS 51. This Interinstitutional Agreement replaces the Interinstitutional Agreement on Better Law-Making of 16 December 2003 (8) and the Interinstitutional Common Approach to impact Assessment of November 2005 (9). The Annex to this Agreement replaces the 2011 Common Understanding on Delegated Acts. 52. This Agreement shall enter into force on the day of its signature. \u0421\u044a\u0441\u0442\u0430\u0432\u0435\u043d\u043e \u0432 \u0421\u0442\u0440\u0430\u0441\u0431\u0443\u0440\u0433, 13 \u0430\u043f\u0440\u0438\u043b 2016 \u0433. Hecho en Estrasburgo, el 13 de abril de 2016. Ve \u0160trasburku dne 13. dubna 2016. Udf\u00e6rdiget i Strasbourg, den 13. april 2016. Geschehen zu Stra\u00dfburg am 13. April 2016. Strasbourg, 13. aprill 2016 \u0388\u03b3\u03b9\u03bd\u03b5 \u03c3\u03c4\u03bf \u03a3\u03c4\u03c1\u03b1\u03c3\u03b2\u03bf\u03cd\u03c1\u03b3\u03bf, 13 \u0391\u03c0\u03c1\u03b9\u03bb\u03af\u03bf\u03c5 2016. Done at Strasbourg, 13 April 2016. Fait \u00e0 Strasbourg, le 13 avril 2016. 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Som skedde i Strasbourg den 13 april 2016. \u0417\u0430 \u0415\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u044f \u043f\u0430\u0440\u043b\u0430\u043c\u0435\u043d\u0442 Por el Parlamento Europeo Za Evropsk\u00fd parlament For Europa-Parlamentet Im Namen des Europ\u00e4ischen Parlaments Euroopa Parlamendi nimel \u0393\u03b9\u03b1 \u03c4\u03bf \u0395\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03cc \u039a\u03bf\u03b9\u03bd\u03bf\u03b2\u03bf\u03cd\u03bb\u03b9\u03bf For the European Parliament Pour le Parlement europ\u00e9en Thar ceann Pharlaimint na hEorpa Za Europski parlament Per il Parlamento europeo Eiroparlamenta v\u0101rd\u0101 Europos Parlamento vardu Az Eur\u00f3pai Parlament r\u00e9sz\u00e9r\u0151l G\u0127all-Parlament Ewropew Voor het Europees Parlement W imieniu Parlamentu Europejskiego Pelo Parlamento Europeu Pentru Parlamentul European Za Eur\u00f3psky parlament Za Evropski parlament Euroopan parlamentin puolesta P\u00e5 Europaparlamentets v\u00e4gnar \u0417\u0430 \u0421\u044a\u0432\u0435\u0442\u0430 Por el Consejo Za Radu P\u00e5 R\u00e5dets vegne Im Namen des Rates N\u00f5ukogu nimel \u0393\u03b9\u03b1 \u03c4\u03bf \u03a3\u03c5\u03bc\u03b2\u03bf\u03cd\u03bb\u03b9\u03bf For the Council Pour le Conseil Thar ceann Comhairle Za Vije\u0107e Per il Consiglio Padomes v\u0101rd\u0101 Tarybos vardu A Tan\u00e1cs r\u00e9sz\u00e9r\u0151l G\u0127all-Kunsill Voor de Raad W imieniu Rady Pelo Conselho Pentru Consiliu Za Radu Za Svet Neuvoston puolesta P\u00e5 r\u00e5dets v\u00e4gnar \u0417\u0430 \u041a\u043e\u043c\u0438\u0441\u0438\u044f\u0442\u0430 Por la Comisi\u00f3n Za Komisi P\u00e5 Kommissionens vegne Im Namen der Kommission Komisjoni nimel \u0393\u03b9\u03b1 \u03c4\u03b7\u03bd \u0395\u03c0\u03b9\u03c4\u03c1\u03bf\u03c0\u03ae For the Commission Pour la Commission Thar ceann an Choimisi\u00fain Za Komisiju Per la Commissione Komisijas v\u0101rd\u0101 Komisijos vardu A Bizotts\u00e1g r\u00e9sz\u00e9r\u0151l G\u0127all-Kummissjoni Voor de Commissie W imieniu Komisji Pela Comiss\u00e3o Pentru Comisie Za Komisiu Za Komisijo Komission puolesta P\u00e5 kommissionens v\u00e4gnar \u041f\u0440\u0435\u0434\u0441\u0435\u0434\u0430\u0442\u0435\u043b/El Presidente/P\u0159edseda/Formand/Der Pr\u00e4sident/President-Eesistuja/O \u03a0\u03c1\u00f3\u03b5\u03b4\u03c1\u03bf\u03c2/The President/Le Pr\u00e9sident/An tUachtar\u00e1n/Predsjednik/Il Presidente/Priek\u0161s\u0113d\u0113t\u0101js/Pirmininkas/Az eln\u00f6k/Il-President/de Voorzitter/Przewodnicz\u0105cy/O Presidente/Pre\u0219edintele/Predseda/Predsednik/Puheenjohtaja/Ordf\u00f6rande Martin SCHULZ Jeanine Antoinette HENNIS-PLASSCHAERT Jean-Claude JUNCKER (1) OJ C 102, 4.4.1996, p. 2. (2) OJ C 73, 17.3.1999, p. 1. (3) OJ C 77, 28.3.2002, p. 1. (4) OJ C 145, 30.6.2007, p. 5. (5) OJ C 369, 17.12.2011, p. 15. (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) OJ C 369, 17.12.2011, p. 14. (8) OJ C 321, 31.12.2003, p. 1. (9) http://ec.europa.eu/smart-regulation/impact/key_docs/docs/ii_common_approach_to_ia_en.pdf ANNEX Common Understanding between the European Parliament, the Council and the Commission on Delegated Acts I. Scope and general principles 1. This Common Understanding builds upon, and replaces, the 2011 Common Understanding on Delegated Acts and streamlines the practice established thereafter by the European Parliament and the Council. It sets out the practical arrangements and agreed clarifications and preferences applicable to delegations of legislative power under Article 290 of the Treaty on the Functioning of the European Union (TFEU). That Article requires that the objectives, content, scope and duration of a delegation be expressly defined in each legislative act that includes such a delegation (\"the basic act\"). 2. In exercising their powers and in compliance with the procedures laid down in the TFEU, the European Parliament, the Council and the Commission (\"the three Institutions\") shall cooperate throughout the procedure with a view to a smooth exercise of delegated power and an effective control of that power by the European Parliament and the Council. To that end, appropriate contacts at administrative level shall be maintained. 3. When proposing delegations of power under Article 290 TFEU, or delegating any such power, the Institutions concerned, depending on the procedure for the adoption of the basic act, undertake to refer as far as possible to the standard clauses set out in the Appendix hereto. II. Consultations in the preparation and drawing-up of delegated acts 4. The Commission shall consult experts designated by each Member State in the preparation of draft delegated acts. The Member States' experts shall be consulted in a timely manner on each draft delegated act prepared by the Commission services (*). The draft delegated acts shall be shared with the Member States' experts. Those consultations shall take place via existing expert groups, or via ad hoc meetings with experts from the Member States, for which the Commission shall send invitations via the Permanent Representations of all Member States. It is for the Member States to decide which experts are to participate. Member States' experts shall be provided with the draft delegated acts, the draft agenda and any other relevant documents in sufficient time to prepare. 5. At the end of any meeting with Member States' experts or in the follow-up to such meetings, the Commission services shall state the conclusions they have drawn from the discussions, including how they will take the experts' views into consideration and how they intend to proceed. Those conclusions will be recorded in the minutes of the meeting. 6. The preparation and drawing-up of delegated acts may also include consultations with stakeholders. 7. Where the material content of a draft delegated act is changed in any way, the Commission shall give Member States' experts the opportunity to react, where appropriate in writing, to the amended version of the draft delegated act. 8. A summary of the consultation process shall be included in the explanatory memorandum accompanying the delegated act. 9. The Commission shall make indicative lists of planned delegated acts available at regular intervals. 10. When preparing and drawing up delegated acts, the Commission shall ensure a timely and simultaneous transmission of all documents, including the draft acts, to the European Parliament and the Council at the same time as to Member States' experts. 11. Where they consider this necessary, the European Parliament and the Council may each send experts to meetings of the Commission expert groups dealing with the preparation of delegated acts to which Member States' experts are invited. To that end, the European Parliament and the Council shall receive the planning for the following months and invitations for all experts meetings. 12. The three Institutions shall indicate to each other their respective functional mailboxes to be used for the transmission and receipt of all documents relating to delegated acts. Once the register referred to in paragraph 29 of this Agreement has been established, it shall be used for that purpose. III. Arrangements for the transmission of documents and computation of time periods 13. By way of an appropriate mechanism, the Commission shall officially transmit the delegated acts to the European Parliament and the Council. Classified documents shall be processed in accordance with internal administrative procedures drawn up by each Institution with a view to providing all the requisite guarantees. 14. In order to ensure that the European Parliament and the Council are able to exercise the rights provided for in Article 290 TFEU within the time limits laid down in each basic act, the Commission shall not transmit any delegated acts during the following periods: \u2014 from 22 December to 6 January; \u2014 from 15 July to 20 August. These periods shall only apply when the period of objection is based on point 18. These periods shall not apply in relation to delegated acts adopted under the urgency procedure provided for in part VI of this Common Understanding. In the event that a delegated act is adopted under the urgency procedure during one of the periods specified in the first subparagraph, the time limit for objection provided for in the basic act shall start to run only when the period in question has come to an end. By October of the year preceding the elections to the European Parliament, the three Institutions shall agree on an arrangement for the notification of delegated acts during the election recess. 15. The period for expressing objections shall start when all official language versions of the delegated act have been received by the European Parliament and the Council. IV. Duration of the delegation 16. The basic act may empower the Commission to adopt delegated acts for an indeterminate or determinate period of time. 17. Where a determinate period of time is prescribed, the basic act should in principle provide for the delegation of power to be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. The Commission shall draw up a report in respect of the delegated power not later than nine months before the end of each period. This point does not affect the European Parliament's or the Council's right of revocation. V. Periods for objection by the European Parliament and Council 18. Without prejudice to the urgency procedure, the period for objection defined on a case-by-case basis in each basic act should in principle be of two months, and not less than that, extendable for each institution (the European Parliament or the Council) by two months at its initiative. 19. However, the delegated act may be published in the Official Journal of the European Union, and may enter into force before the expiry of that period, if the European Parliament and the Council have both informed the Commission that they will not object. VI. Urgency procedure 20. An urgency procedure should be reserved for exceptional cases, such as security and safety matters, the protection of health and safety, or external relations, including humanitarian crises. The European Parliament and the Council should justify the choice of an urgency procedure in the basic act. The basic act shall specify the cases in which the urgency procedure is to be used. 21. The Commission undertakes to keep the European Parliament and the Council fully informed about the possibility of a delegated act being adopted under the urgency procedure. As soon as the Commission services anticipate such a possibility, they shall informally forewarn the secretariats of the European Parliament and the Council to that effect via the functional mailboxes referred to in point 12. 22. A delegated act adopted under the urgency procedure shall enter into force without delay and shall apply as long as no objection is expressed within the period provided for in the basic act. If an objection is expressed by the European Parliament or by the Council, the Commission shall repeal the act immediately following notification by the European Parliament or the Council of the decision to object. 23. When notifying a delegated act under the urgency procedure to European Parliament and the Council, the Commission shall state the reasons for the use of that procedure. VII. Publication in the Official Journal 24. Delegated acts shall be published in the L series of the Official Journal of the European Union only after the expiry of the period for objection, save in the circumstances set out in point 19. Delegated acts adopted under the urgency procedure shall be published without delay. 25. Without prejudice to Article 297 TFEU, decisions by the European Parliament or Council to revoke a delegation of power, to object to a delegated act adopted under the urgency procedure or to oppose the tacit renewal of a delegation of power shall also be published in the L series of the Official Journal of the European Union. A decision to revoke shall enter into force the day following its publication in the Official Journal of the European Union. 26. The Commission shall also publish in the Official Journal of the European Union decisions repealing delegated acts adopted under the urgency procedure. VIII. Mutual exchange of information, in particular in the event of a revocation 27. When exercising their rights in applying the conditions laid down in the basic act, the European Parliament and the Council will inform each other and the Commission. 28. When either the European Parliament or the Council initiates a procedure which could lead to the revocation of a delegation of power, it will inform the other two Institutions at the latest one month before taking the decision to revoke. (*) The specificities of the procedure for preparing regulatory technical standards (RTS) as described in the ESA Regulations [Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12), Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48) and Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84)] will be taken into account without prejudice to the consultation arrangements laid down in this Agreement. Appendix Standard clauses Recital: In order to \u2026 [objective], the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of \u2026 [content and scope]. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. Article(s) delegating power The Commission [shall adopt/is empowered to adopt] delegated acts in accordance with Article [A] concerning \u2026 [content and scope]. The following supplementary paragraph is to be added where the urgency procedure applies: Where, in the case of \u2026 [content and scope], imperative grounds of urgency so require, the procedure provided for in Article [B] shall apply to delegated acts adopted pursuant to this Article. Article [A] Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. [duration] Option 1: 2. The power to adopt delegated acts referred to in Article(s) \u2026 shall be conferred on the Commission for an indeterminate period of time from \u2026 [date of entry into force of the basic legislative act or any other date set by the co-legislators]. Option 2: 2. The power to adopt delegated acts referred to in Article(s) \u2026 shall be conferred on the Commission for a period of \u2026 years from \u2026 [date of entry into force of the basic legislative act or any other date set by the co-legislators]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the \u2026-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. Option 3: 2. The power to adopt delegated acts referred to in Article[s] \u2026 shall be conferred on the Commission for a period of \u2026 years from the \u2026 [date of entry into force of the basic legislative act or any other date set by the co-legislators]. 3. The delegation of power referred to in Article(s) \u2026 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article(s) \u2026 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of [two months] of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by [two months] at the initiative of the European Parliament or of the Council. The following supplementary article is to be added where the urgency procedure applies: Article [B] Urgency procedure 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article [A](6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.", "summary": "Better Law-Making \u2014 Agreement between EU institutions Better Law-Making \u2014 Agreement between EU institutions SUMMARY OF: Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making WHAT IS THE AIM OF THIS AGREEMENT? It aims to improve the way the EU makes laws by ensuring that the European Parliament, the Council and the European Commission (\u2018the 3 Institutions\u2019) are committed to sincere and transparent cooperation throughout the entire legislative cycle. The agreement replaces the Interinstitutional Agreement of 16 December 2003 without prejudice to the Framework Agreement on relations between the Parliament and the Commission of 20 October 2010. KEY POINTS Annual and multiannual programming At the beginning of each legislature, the 3 Institutions will agree on multiannual priorities. In addition, they will each year adopt a joint declaration on annual interinstitutional priorities based on the Commission\u2019s annual work programme. The first such Joint Declaration was adopted for 2017. Impact assessments The agreement establishes that the Commission should carry out impact assessments for all its major legislative and non-legislative proposals. The elements that should be covered by impact assessments include: economic, environmental and social impacts; subsidiarity and proportionality; impacts on competitiveness and SMEs in particular; digital aspects; territorial impacts. The Commission will rely on a Regulatory Scrutiny Board, partly made up of external experts, to carry out an objective quality check of the Commission\u2019s impact assessment. The Parliament and the Council may carry out impact assessments on their substantial amendments when they consider this appropriate and necessary. In addition, the agreement sets rules for public and stakeholder consultations and ex post evaluation of EU legislation. TransparencyThe Agreement stresses the importance of enhancing the transparency of legislative procedures, including: agreeing improved practical arrangements between the 3 Institutions for cooperation and information-sharing on international agreements; an appropriate handling of trilogues*; joint public announcements of the successful outcome of the legislative process; a joint database on legislative files allowing clear traceability of the various steps of the legislative process. Delegated and implementing acts The Agreement sets rules to clarify and facilitate the use of delegated and implementing acts in accordance with Articles 290 and 291 of the Treaty on the Functioning of the European Union (TFEU) and contains an annex with standard clauses to this effect. In particular, it was agreed that: the Commission will consult EU countries\u2019 experts in the preparation of delegated acts, and Parliament and Council experts will have equal access to all related meetings and documents; there will be a prompt alignment of all pre-Lisbon Treaty files; a further negotiation will take place to specify non-binding delineation criteria for delegated and implementing acts (i.e. non-binding criteria for the application of Articles 290 and 291 TFEU); and a public register for delegated acts will be set up (the Interinstitutional Register of Delegated Acts \u2018DelReg\u2019 has been in operation since the end of 2017). Implementing and applying EU lawThe agreement includes 3 innovations to help improve and clarify the implementation and application of EU law: 1.EU countries must clearly inform the public of measures taken in EU countries that incorporate EU law into national law or implement EU law, in line with the Joint Declarations of 2011 regarding explanatory documents which accompany the notification of such measures; 2.EU countries are asked to clearly identify in the transposing act (i.e. the act that incorporates the EU legislation into national law) or associated document when they add aspects to their national law which are in no way related to what the EU act contains (\u2018gold plating\u2019); 3.the Commission should include any instances of gold plating in its annual report to the Parliament and the Council. SimplificationThe Agreement requires the 3 institutions to cooperate to simplify legislation and reduce burdens whilst ensuring that the objectives of the legislation are met. The 3 Institutions confirm: their commitment to using the technique of recasting to modify existing legislation more frequently and, where recasting is not appropriate, codifying legislative texts as soon as possible after the adoption of an amending act; their will to promote the most efficient regulatory instruments, such as harmonisation and mutual recognition, to avoid over-regulation and reduce administrative burdens. The Commission presents an annual burden survey of the results of the EU\u2019s efforts to simplify legislation and reduce administrative burdens, making use of its Regulatory Fitness and Performance Programme (REFIT). Implementation of the Agreement Paragraph 50 of the Agreement envisages that the 3 Institutions regularly take stock of its implementation via the Interinstitutional Coordination Group and that they meet annually at political level to evaluate progress. FROM WHEN DOES THE AGREEMENT APPLY? It has applied since 13 April 2016. BACKGROUND For more information, see: Interinstitutional Agreement on Better Law-making \u2014 briefing (European Parliament) Better Law-Making Agreement (Council of the European Union). KEY TERMS Trilogues: informal tripartite meetings attended by representatives of the European Parliament, the Council and the Commission. MAIN DOCUMENT Interinstitutional agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, pp. 1-14) RELATED DOCUMENTS European Parliament decision of 9 March 2016 on the conclusion of an Interinstitutional Agreement on Better Law-Making between the European Parliament, the Council of the European Union and the European Commission (2016/2005(ACI)) (OJ C 50, 9.2.2018, pp. 91\u201397) Joint Declaration on the EU\u2019s legislative priorities 2018-2019 (OJ C 446, 29.12.2017, pp. 1\u20133) Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Six \u2014 Institutional and financial provisions \u2014 Title I \u2014 Institutional provisions \u2014 Chapter 2 \u2014 Legal acts of the Union, adoption procedures and other provisions \u2014 Section 1 \u2014 The legal acts of the Union \u2014 Article 290 (OJ C 202, 7.6.2016, p. 172) Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Six \u2014 Institutional and financial provisions \u2014 Title I \u2014 Institutional provisions \u2014 Chapter 2 \u2014 Legal acts of the Union, adoption procedures and other provisions \u2014 Section 1 \u2014 The legal acts of the Union \u2014 Article 291 (OJ C 202, 7.6.2016, p. 173) Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Six \u2014 Institutional and financial provisions \u2014 Title I \u2014 Institutional provisions \u2014 Chapter 2 \u2014 Legal acts of the Union, adoption procedures and other provisions \u2014 Section 2 \u2014 Procedures for the adoption of acts and other provisions \u2014 Article 295 (OJ C 202, 7.6.2016, p. 175) Joint Declaration on the EU\u2019s legislative priorities for 2017 (OJ C 484, 24.12.2016, pp. 7\u20138) Statement of the European Parliament and of the Commission on the occasion of the adoption of the Interinstitutional Agreement on Better Law-Making of 13 April 2016 (OJ L 124, 13.5.2016, p. 1) Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (OJ C 369, 17.12.2011, p. 14) Joint Political Declaration of 27 October 2011 of the European Parliament, the Council and the Commission on explanatory documents (OJ C 369, 17.12.2011, p. 15) Framework agreement on relations between the European Parliament and the European Commission (OJ L 304, 20.11.2010, pp. 47-62) Interinstitutional Agreement on better law-making (OJ C 321, 31.12.2003, pp. 1\u20135) last update 31.07.2018"}
{"article": "11.3.2011 EN Official Journal of the European Union L 65/1 REGULATION (EU) No 211/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 February 2011 on the citizens\u2019 initiative THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 24 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Treaty on European Union (TEU) reinforces citizenship of the Union and enhances further the democratic functioning of the Union by providing, inter alia, that every citizen is to have the right to participate in the democratic life of the Union by way of a European citizens\u2019 initiative. That procedure affords citizens the possibility of directly approaching the Commission with a request inviting it to submit a proposal for a legal act of the Union for the purpose of implementing the Treaties similar to the right conferred on the European Parliament under Article 225 of the Treaty on the Functioning of the European Union (TFEU) and on the Council under Article 241 TFEU. (2) The procedures and conditions required for the citizens\u2019 initiative should be clear, simple, user-friendly and proportionate to the nature of the citizens\u2019 initiative so as to encourage participation by citizens and to make the Union more accessible. They should strike a judicious balance between rights and obligations. (3) They should also ensure that citizens of the Union are subject to similar conditions for supporting a citizens\u2019 initiative regardless of the Member State from which they come. (4) The Commission should, upon request, provide citizens with information and informal advice about citizens\u2019 initiatives, notably as regards the registration criteria. (5) It is necessary to establish the minimum number of Member States from which citizens must come. In order to ensure that a citizens\u2019 initiative is representative of a Union interest, while ensuring that the instrument remains easy to use, that number should be set at one quarter of Member States. (6) For that purpose, it is also appropriate to establish the minimum number of signatories coming from each of those Member States. In order to ensure similar conditions for citizens to support a citizens\u2019 initiative, those minimum numbers should be degressively proportional. For the purpose of clarity, those minimum numbers should be set out for each Member State in an annex to this Regulation. The minimum number of signatories required in each Member State should correspond to the number of Members of the European Parliament elected in each Member State, multiplied by 750. The Commission should be empowered to amend that annex in order to reflect any modification in the composition of the European Parliament. (7) It is appropriate to fix a minimum age for supporting a citizens\u2019 initiative. That should be set as the age at which citizens are entitled to vote in elections to the European Parliament. (8) A minimum organised structure is needed in order to successfully carry through a citizens\u2019 initiative. That should take the form of a citizens\u2019 committee, composed of natural persons (organisers) coming from at least seven different Member States, in order to encourage the emergence of European-wide issues and to foster reflection on those issues. For the sake of transparency and smooth and efficient communication, the citizens\u2019 committee should designate representatives to liaise between the citizens\u2019 committee and the institutions of the Union throughout the procedure. (9) Entities, notably organisations which under the Treaties contribute to forming European political awareness and to expressing the will of citizens of the Union, should be able to promote a citizens\u2019 initiative, provided that they do so with full transparency. (10) In order to ensure coherence and transparency in relation to proposed citizens\u2019 initiatives and to avoid a situation where signatures are being collected for a proposed citizens\u2019 initiative which does not comply with the conditions laid down in this Regulation, it should be mandatory to register such initiatives on a website made available by the Commission prior to collecting the necessary statements of support from citizens. All proposed citizens\u2019 initiatives that comply with the conditions laid down in this Regulation should be registered by the Commission. The Commission should deal with registration in accordance with the general principles of good administration. (11) Once a proposed citizens\u2019 initiative is registered, statements of support from citizens may be collected by the organisers. (12) It is appropriate to set out the form for the statement of support in an annex to this Regulation, specifying the data required for the purposes of verification by the Member States. The Commission should be empowered to amend that annex in accordance with Article 290 TFEU, taking into account information forwarded to it by Member States. (13) With due respect for the principle that personal data must be adequate, relevant and not excessive in relation to the purposes for which they are collected, the provision of personal data, including, where applicable, a personal identification number or a personal identification document number by signatories of a proposed citizens\u2019 initiative is required as far as may be necessary in order to allow for the verification of statements of support by Member States, in accordance with national law and practice. (14) In order to put modern technology to good use as a tool of participatory democracy, it is appropriate to provide for statements of support to be collected online as well as in paper form. Online collection systems should have adequate security features in place in order to ensure, inter alia, that the data are securely collected and stored. For that purpose, the Commission should set out detailed technical specifications for online collection systems. (15) It is appropriate for Member States to verify the conformity of online collection systems with the requirements of this Regulation before statements of support are collected. (16) The Commission should make available an open-source software incorporating the relevant technical and security features necessary in order to comply with the provisions of this Regulation as regards online collection systems. (17) It is appropriate to ensure that statements of support for a citizens\u2019 initiative are collected within a specific time limit. In order to ensure that proposed citizens\u2019 initiatives remain relevant, whilst taking account of the complexity of collecting statements of support across the Union, that time limit should not be longer than 12 months from the date of registration of the proposed citizens\u2019 initiative. (18) It is appropriate to provide that, where a citizens\u2019 initiative has received the necessary statements of support from signatories, each Member State should be responsible for the verification and certification of statements of support collected from signatories coming from that Member State. Taking account of the need to limit the administrative burden for Member States, they should, within a period of three months from receipt of a request for certification, carry out such verifications on the basis of appropriate checks, which may be based on random sampling, and should issue a document certifying the number of valid statements of support received. (19) Organisers should ensure that all the relevant conditions set out in this Regulation are met prior to submitting a citizens\u2019 initiative to the Commission. (20) The Commission should examine a citizens\u2019 initiative and set out its legal and political conclusions separately. It should also set out the action it intends to take in response to it, within a period of three months. In order to demonstrate that a citizens\u2019 initiative supported by at least one million Union citizens and its possible follow-up are carefully examined, the Commission should explain in a clear, comprehensible and detailed manner the reasons for its intended action, and should likewise give its reasons if it does not intend to take any action. When the Commission has received a citizens\u2019 initiative supported by the requisite number of signatories which fulfils the other requirements of this Regulation, the organisers should be entitled to present that initiative at a public hearing at Union level. (21) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (4) is fully applicable to the processing of personal data carried out in application of this Regulation. In this respect, for the sake of legal certainty, it is appropriate to clarify that the organisers of a citizens\u2019 initiative and the competent authorities of the Member States are the data controllers within the meaning of Directive 95/46/EC and to specify the maximum period within which the personal data collected for the purposes of a citizens\u2019 initiative may be retained. In their capacity as data controllers, organisers need to take all the appropriate measures to comply with the obligations imposed by Directive 95/46/EC, in particular those relating to the lawfulness of the processing, the security of the processing activities, the provision of information and the rights of data subjects to have access to their personal data, as well as to procure the correction and erasure of their personal data. (22) The provisions of Chapter III of Directive 95/46/EC on judicial remedies, liability and sanctions are fully applicable as regards the data processing carried out in application of this Regulation. Organisers of a citizens\u2019 initiative should be liable in accordance with applicable national law for any damage that they cause. In addition, Member States should ensure that organisers are subject to appropriate penalties for infringements of this Regulation. (23) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (5) is fully applicable to the processing of personal data carried out by the Commission in application of this Regulation. (24) In order to address future adaptation needs, the Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU for the purpose of amending the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. (25) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6). (26) This Regulation respects fundamental rights and observes the principles enshrined in the Charter of Fundamental Rights of the European Union, in particular Article 8 thereof, which states that everyone has the right to the protection of personal data concerning him or her. (27) The European Data Protection Supervisor was consulted and adopted an opinion (7), HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes the procedures and conditions required for a citizens\u2019 initiative as provided for in Article 11 TEU and Article 24 TFEU. Article 2 Definitions For the purpose of this Regulation the following definitions shall apply: 1. \u2018citizens\u2019 initiative\u2019 means an initiative submitted to the Commission in accordance with this Regulation, inviting the Commission, within the framework of its powers, to submit any appropriate proposal on matters where citizens consider that a legal act of the Union is required for the purpose of implementing the Treaties, which has received the support of at least one million eligible signatories coming from at least one quarter of all Member States; 2. \u2018signatories\u2019 means citizens of the Union who have supported a given citizens\u2019 initiative by completing a statement of support form for that initiative; 3. \u2018organisers\u2019 means natural persons forming a citizens\u2019 committee responsible for the preparation of a citizens\u2019 initiative and its submission to the Commission. Article 3 Requirements for organisers and for signatories 1. The organisers shall be citizens of the Union and be of the age to be entitled to vote in elections to the European Parliament. 2. The organisers shall form a citizens\u2019 committee of at least seven persons who are residents of at least seven different Member States. The organisers shall designate one representative and one substitute (\u2018the contact persons\u2019), who shall liaise between the citizens\u2019 committee and the institutions of the Union throughout the procedure and who shall be mandated to speak and act on behalf of the citizens\u2019 committee. Organisers who are Members of the European Parliament shall not be counted for the purposes of reaching the minimum number required to form a citizens\u2019 committee. For the purpose of registering a proposed citizens\u2019 initiative in accordance with Article 4, only the information concerning the seven members of the citizens\u2019 committee who are needed in order to comply with the requirements laid down in paragraph 1 of this Article and in this paragraph shall be considered by the Commission. 3. The Commission may request the organisers to provide appropriate proof that the requirements laid down in paragraphs 1 and 2 are fulfilled. 4. In order to be eligible to support a proposed citizens\u2019 initiative, signatories shall be citizens of the Union and shall be of the age to be entitled to vote in elections to the European Parliament. Article 4 Registration of a proposed citizens\u2019 initiative 1. Prior to initiating the collection of statements of support from signatories for a proposed citizens\u2019 initiative, the organisers shall be required to register it with the Commission, providing the information set out in Annex II, in particular on the subject matter and objectives of the proposed citizens\u2019 initiative. That information shall be provided in one of the official languages of the Union, in an online register made available for that purpose by the Commission (\u2018the register\u2019). The organisers shall provide, for the register and where appropriate on their website, regularly updated information on the sources of support and funding for the proposed citizens\u2019 initiative. After the registration is confirmed in accordance with paragraph 2, the organisers may provide the proposed citizens\u2019 initiative in other official languages of the Union for inclusion in the register. The translation of the proposed citizens\u2019 initiative into other official languages of the Union shall be the responsibility of the organisers. The Commission shall establish a point of contact which provides information and assistance. 2. Within two months from the receipt of the information set out in Annex II, the Commission shall register a proposed citizens\u2019 initiative under a unique registration number and send a confirmation to the organisers, provided that the following conditions are fulfilled: (a) the citizens\u2019 committee has been formed and the contact persons have been designated in accordance with Article 3(2); (b) the proposed citizens\u2019 initiative does not manifestly fall outside the framework of the Commission\u2019s powers to submit a proposal for a legal act of the Union for the purpose of implementing the Treaties; (c) the proposed citizens\u2019 initiative is not manifestly abusive, frivolous or vexatious; and (d) the proposed citizens\u2019 initiative is not manifestly contrary to the values of the Union as set out in Article 2 TEU. 3. The Commission shall refuse the registration if the conditions laid down in paragraph 2 are not met. Where it refuses to register a proposed citizens\u2019 initiative, the Commission shall inform the organisers of the reasons for such refusal and of all possible judicial and extrajudicial remedies available to them. 4. A proposed citizens\u2019 initiative that has been registered shall be made public in the register. Without prejudice to their rights under Regulation (EC) No 45/2001, data subjects shall be entitled to request the removal of their personal data from the register after the expiry of a period of two years from the date of registration of a proposed citizens\u2019 initiative. 5. At any time before the submission of statements of support in accordance with Article 8, the organisers may withdraw a proposed citizens\u2019 initiative that has been registered. In that case, an indication to that effect shall be entered in the register. Article 5 Procedures and conditions for the collection of statements of support 1. The organisers shall be responsible for the collection of the statements of support from signatories for a proposed citizens\u2019 initiative which has been registered in accordance with Article 4. Only forms which comply with the models set out in Annex III and which are in one of the language versions included in the register for that proposed citizens\u2019 initiative may be used for the collection of statements of support. The organisers shall complete the forms as indicated in Annex III prior to initiating the collection of statements of support from signatories. The information given in the forms shall correspond to the information contained in the register. 2. The organisers may collect statements of support in paper form or electronically. Where statements of support are collected online, Article 6 shall apply. For the purpose of this Regulation, statements of support which are electronically signed using an advanced electronic signature, within the meaning of Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures (8), shall be treated in the same way as statements of support in paper form. 3. Signatories shall be required to complete statement of support forms made available by the organisers. They shall indicate only the personal data that are required for the purposes of verification by the Member States, as set out in Annex III. Signatories may only support a given proposed citizens\u2019 initiative once. 4. Member States shall forward to the Commission any changes to the information set out in Annex III. Taking into account those changes, the Commission may adopt, by means of delegated acts, in accordance with Article 17 and subject to the conditions of Articles 18 and 19, amendments to Annex III. 5. All statements of support shall be collected after the date of registration of the proposed citizens\u2019 initiative and within a period not exceeding 12 months. At the end of that period, the register shall indicate that the period has expired and, where appropriate, that the required number of statements of support was not collected. Article 6 Online collection systems 1. Where statements of support are collected online, the data obtained through the online collection system shall be stored in the territory of a Member State. The online collection system shall be certified in accordance with paragraph 3 in the Member State in which the data collected through the online collection system will be stored. The organisers may use one online collection system for the purpose of collecting statements of support in several or all Member States. The models for the statement of support forms may be adapted for the purpose of the online collection. 2. The organisers shall ensure that the online collection system used for the collection of statements of support complies with paragraph 4. Prior to initiating the collection of statements of support, the organisers shall request the competent authority of the relevant Member State to certify that the online collection system used for that purpose complies with paragraph 4. The organisers may only start collecting statements of support through the online collection system once they have obtained the certificate referred to in paragraph 3. The organisers shall make a copy of that certificate publicly available on the website used for the online collection system. By 1 January 2012, the Commission shall set up and thereafter shall maintain open-source software incorporating the relevant technical and security features necessary for compliance with the provisions of this Regulation regarding the online collection systems. The software shall be made available free of charge. 3. Where the online collection system complies with paragraph 4, the relevant competent authority shall within one month issue a certificate to that effect in accordance with the model set out in Annex IV. Member States shall recognise the certificates issued by the competent authorities of other Member States. 4. Online collection systems shall have adequate security and technical features in place in order to ensure that: (a) only natural persons may submit a statement of support form online; (b) the data provided online are securely collected and stored, in order to ensure, inter alia, that they may not be modified or used for any purpose other than their indicated support of the given citizens\u2019 initiative and to protect personal data against accidental or unlawful destruction or accidental loss, alteration or unauthorised disclosure or access; (c) the system can generate statements of support in a form complying with the models set out in Annex III, in order to allow for the verification by the Member States in accordance with Article 8(2). 5. By 1 January 2012, the Commission shall adopt technical specifications for the implementation of paragraph 4, in accordance with the regulatory procedure referred to in Article 20(2). Article 7 Minimum number of signatories per Member State 1. The signatories of a citizens\u2019 initiative shall come from at least one quarter of Member States. 2. In at least one quarter of Member States, signatories shall comprise at least the minimum number of citizens set out, at the time of registration of the proposed citizens\u2019 initiative, in Annex I. Those minimum numbers shall correspond to the number of the Members of the European Parliament elected in each Member State, multiplied by 750. 3. The Commission shall adopt, by means of delegated acts, in accordance with Article 17 and subject to the conditions of Articles 18 and 19, appropriate adjustments to Annex I in order to reflect any modification in the composition of the European Parliament. 4. Signatories shall be considered as coming from the Member State which is responsible for the verification of their statement of support in accordance with the second subparagraph of Article 8(1). Article 8 Verification and certification by Member States of statements of support 1. After collecting the necessary statements of support from signatories in accordance with Articles 5 and 7, the organisers shall submit the statements of support, in paper or electronic form, to the relevant competent authorities referred to in Article 15 for verification and certification. For that purpose the organisers shall use the form set out in Annex V and shall separate those statements of support collected in paper form, those which were electronically signed using an advanced electronic signature and those collected through an online collection system. The organisers shall submit statements of support to the relevant Member State as follows: (a) to the Member State of residence or of nationality of the signatory, as specified in point 1 of Part C of Annex III, or (b) to the Member State that issued the personal identification number or the personal identification document indicated in the statement of support, as specified in point 2 of Part C of Annex III. 2. The competent authorities shall, within a period not exceeding three months from receipt of the request, verify the statements of support submitted on the basis of appropriate checks, in accordance with national law and practice, as appropriate. On that basis they shall deliver to the organisers a certificate in accordance with the model set out in Annex VI, certifying the number of valid statements of support for the Member State concerned. For the purpose of the verification of statements of support, the authentication of signatures shall not be required. 3. The certificate provided for in paragraph 2 shall be issued free of charge. Article 9 Submission of a citizens\u2019 initiative to the Commission After obtaining the certificates provided for in Article 8(2), and provided that all relevant procedures and conditions set out in this Regulation have been complied with, the organisers may submit the citizens\u2019 initiative to the Commission, accompanied by information regarding any support and funding received for that initiative. That information shall be published in the register. The amount of support and funding received from any source in excess of which information is to be provided shall be identical to that set out in Regulation (EC) No 2004/2003 of the European Parliament and of the Council of 4 November 2003 on the regulations governing political parties at European level and the rules regarding their funding (9). For the purpose of this Article, the organisers shall make use of the form set out in Annex VII and shall submit the completed form together with copies, in paper or electronic form, of the certificates provided for in Article 8(2). Article 10 Procedure for the examination of a citizens\u2019 initiative by the Commission 1. Where the Commission receives a citizens\u2019 initiative in accordance with Article 9 it shall: (a) publish the citizens\u2019 initiative without delay in the register; (b) receive the organisers at an appropriate level to allow them to explain in detail the matters raised by the citizens\u2019 initiative; (c) within three months, set out in a communication its legal and political conclusions on the citizens\u2019 initiative, the action it intends to take, if any, and its reasons for taking or not taking that action. 2. The communication referred to in paragraph 1(c) shall be notified to the organisers as well as to the European Parliament and the Council and shall be made public. Article 11 Public hearing Where the conditions of Article 10(1)(a) and (b) are fulfilled, and within the deadline laid down in Article 10(1)(c), the organisers shall be given the opportunity to present the citizens\u2019 initiative at a public hearing. The Commission and the European Parliament shall ensure that this hearing is organised at the European Parliament, if appropriate together with such other institutions and bodies of the Union as may wish to participate, and that the Commission is represented at an appropriate level. Article 12 Protection of personal data 1. In processing personal data pursuant to this Regulation, the organisers of a citizens\u2019 initiative and the competent authorities of the Member State shall comply with Directive 95/46/EC and the national provisions adopted pursuant thereto. 2. For the purposes of their respective processing of personal data, the organisers of a citizens\u2019 initiative and the competent authorities designated in accordance with Article 15(2) shall be considered as data controllers in accordance with Article 2(d) of Directive 95/46/EC. 3. The organisers shall ensure that personal data collected for a given citizen\u2019s initiative are not used for any purpose other than their indicated support for that initiative, and shall destroy all statements of support received for that initiative and any copies thereof at the latest one month after submitting that initiative to the Commission in accordance with Article 9 or 18 months after the date of registration of the proposed citizens\u2019 initiative, whichever is the earlier. 4. The competent authority shall use the personal data it receives for a given citizens\u2019 initiative only for the purpose of verifying the statements of support in accordance with Article 8(2), and shall destroy all statements of support and copies thereof at the latest one month after issuing the certificate referred to in that Article. 5. Statements of support for a given citizens\u2019 initiative and copies thereof may be retained beyond the time limits laid down in paragraphs 3 and 4 if necessary for the purpose of legal or administrative proceedings relating to a proposed citizen\u2019s initiative. The organisers and the competent authority shall destroy all statements of support and copies thereof at the latest one week after the date of conclusion of the said proceedings by a final decision. 6. The organisers shall implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing. Article 13 Liability Organisers shall be liable for any damage they cause in the organisation of a citizens\u2019 initiative in accordance with applicable national law. Article 14 Penalties 1. Member States shall ensure that organisers are subject to appropriate penalties for infringements of this Regulation and in particular for: (a) false declarations made by organisers; (b) the fraudulent use of data. 2. The penalties referred to in paragraph 1 shall be effective, proportionate and dissuasive. Article 15 Competent authorities within the Member States 1. For the purpose of the implementation of Article 6(3), Member States shall designate competent authorities responsible for issuing the certificate provided for therein. 2. For the purpose of the implementation of Article 8(2), each Member State shall designate one competent authority responsible for coordinating the process of verification of statements of support and for delivering the certificates provided for therein. 3. Not later than 1 March 2012, Member States shall forward the names and addresses of the competent authorities to the Commission. 4. The Commission shall make the list of competent authorities publicly available. Article 16 Amendment of the Annexes The Commission may adopt, by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19, amendments to the Annexes to this Regulation within the scope of the relevant provisions of this Regulation. Article 17 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Article 16 shall be conferred on the Commission for an indeterminate period of time. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 18 and 19. Article 18 Revocation of the delegation 1. The delegation of power referred to in Article 16 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 19 Objections to delegated acts 1. The European Parliament or the Council may object to the delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act. Article 20 Committee 1. For the purpose of the implementation of Article 6(5), the Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. Article 21 Notification of national provisions Each Member State shall notify to the Commission the specific provisions it adopts in order to implement this Regulation. The Commission shall inform the other Member States thereof. Article 22 Review By 1 April 2015, and every three years thereafter, the Commission shall present a report to the European Parliament and the Council on the application of this Regulation. Article 23 Entry into force and application This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 April 2012. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 February 2011. For the European Parliament The President J. BUZEK For the Council The President MARTONYI J. (1) OJ C 44, 11.2.2011, p. 182. (2) OJ C 267, 1.10.2010, p. 57. (3) Position of the European Parliament of 15 December 2010 (not yet published in the Official Journal) and decision of the Council of 14 February 2011. (4) OJ L 281, 23.11.1995, p. 31. (5) OJ L 8, 12.1.2001, p. 1. (6) OJ L 184, 17.7.1999, p. 23. (7) OJ C 323, 30.11.2010, p. 1. (8) OJ L 13, 19.1.2000, p. 12. (9) OJ L 297, 15.11.2003, p. 1. ANNEX I MINIMUM NUMBER OF SIGNATORIES PER MEMBER STATE Belgium 16 500 Bulgaria 12 750 Czech Republic 16 500 Denmark 9 750 Germany 74 250 Estonia 4 500 Ireland 9 000 Greece 16 500 Spain 37 500 France 54 000 Italy 54 000 Cyprus 4 500 Latvia 6 000 Lithuania 9 000 Luxembourg 4 500 Hungary 16 500 Malta 3 750 Netherlands 18 750 Austria 12 750 Poland 37 500 Portugal 16 500 Romania 24 750 Slovenia 5 250 Slovakia 9 750 Finland 9 750 Sweden 13 500 United Kingdom 54 000 ANNEX II REQUIRED INFORMATION FOR REGISTERING A PROPOSED CITIZENS\u2019 INITIATIVE The following information shall be provided in order to register a proposed citizens\u2019 initiative on the Commission\u2019s online register: 1. The title of the proposed citizens\u2019 initiative, in no more than 100 characters; 2. The subject matter, in no more than 200 characters; 3. A description of the objectives of the proposed citizens\u2019 initiative on which the Commission is invited to act, in no more than 500 characters; 4. The provisions of the Treaties considered relevant by the organisers for the proposed action; 5. The full names, postal addresses, nationalities and dates of birth of the seven members of the citizens\u2019 committee, indicating specifically the representative and the substitute as well as their e-mail addresses (1); 6. All sources of support and funding for the proposed citizens\u2019 initiative at the time of registration (1). Organisers may provide more detailed information on the subject, objectives and background to the proposed citizens\u2019 initiative in an annex. They may also, if they wish, submit a draft legal act. (1) Privacy statement: in accordance with Article 11 of Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data, data subjects are informed that these personal data are compiled by the Commission for the purpose of the procedure in respect of the proposed citizens\u2019 initiative. Only the full names of the organisers, the e-mail addresses of the contact persons and information relating to the sources of support and funding will be made available to the public on the Commission\u2019s online register. Data subjects are entitled to object to the publication of their personal data on compelling legitimate grounds relating to their particular situation, and to request the rectification of that data at any time and its removal from the Commission\u2019s online register after the expiry of a period of two years from the date of registration of the proposed citizens\u2019 initiative. ANNEX III PART C 1. List of Member States which do not require the provision of a personal identification number/personal identification document number (statement of support form \u2014 Part A): Member State Signatories whose statement of support is to be submitted to the Member State concerned Belgium \u2014 residents in Belgium \u2014 Belgian nationals residing outside the country if they have informed their national authorities of their place of residence Denmark \u2014 residents in Denmark \u2014 Danish nationals residing outside the country if they have informed their national authorities of their place of residence Germany \u2014 residents in Germany \u2014 German nationals residing outside the country if they have informed their national authorities of their place of residence Estonia \u2014 residents in Estonia \u2014 Estonian nationals residing outside the country Ireland \u2014 residents in Ireland Netherlands \u2014 residents in the Netherlands Slovakia \u2014 residents in Slovakia \u2014 Slovak nationals residing outside the country Finland \u2014 residents in Finland \u2014 Finnish nationals residing outside the country United Kingdom \u2014 residents in the United Kingdom 2. List of Member States which require the provision of one of the personal identification numbers/personal identification document numbers, as specified below, in the statement of support form \u2014 Part B: BULGARIA \u2014 \u0415\u0434\u0438\u043d\u0435\u043d \u0433\u0440\u0430\u0436\u0434\u0430\u043d\u0441\u043a\u0438 \u043d\u043e\u043c\u0435\u0440 (personal number) CZECH REPUBLIC \u2014 Ob\u010dansk\u00fd pr\u016fkaz (national identity card) \u2014 Cestovn\u00ed pas (passport) GREECE \u2014 \u0394\u03b5\u03bb\u03c4\u03af\u03bf \u0391\u03c3\u03c4\u03c5\u03bd\u03bf\u03bc\u03b9\u03ba\u03ae\u03c2 \u03a4\u03b1\u03c5\u03c4\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 (identity card) \u2014 \u0394\u03b9\u03b1\u03b2\u03b1\u03c4\u03ae\u03c1\u03b9\u03bf (passport) \u2014 \u0392\u03b5\u03b2\u03b1\u03af\u03c9\u03c3\u03b7 \u0395\u03b3\u03b3\u03c1\u03b1\u03c6\u03ae\u03c2 \u03a0\u03bf\u03bb\u03b9\u03c4\u03ce\u03bd \u0395.\u0395./\u0388\u03b3\u03b3\u03c1\u03b1\u03c6\u03bf \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7\u03c2 \u03bc\u03cc\u03bd\u03b9\u03bc\u03b7\u03c2 \u03b4\u03b9\u03b1\u03bc\u03bf\u03bd\u03ae\u03c2 \u03c0\u03bf\u03bb\u03af\u03c4\u03b7 \u0395.\u0395. (residence certificate/permanent residence certificate) SPAIN \u2014 Documento Nacional de Identidad (identity card) \u2014 Pasaporte (passport) FRANCE \u2014 Passeport (passport) \u2014 Carte nationale d\u2019identit\u00e9 (national identity card) \u2014 Titre de s\u00e9jour (residence permit) \u2014 Permis de conduire (driving licence) \u2014 Autre (other): \u2014 Carte d\u2019identit\u00e9 de parlementaire avec photographie, d\u00e9livr\u00e9e par le pr\u00e9sident d\u2019une assembl\u00e9e parlementaire (parliamentarian\u2019s identity card with photo, issued by the president of a parliamentary assembly), \u2014 Carte d\u2019identit\u00e9 d\u2019\u00e9lu local avec photographie, d\u00e9livr\u00e9e par le repr\u00e9sentant de l\u2019Etat (elected local official\u2019s identity card with photo, issued by the State representative), \u2014 Carte du combattant de couleur chamois ou tricolore (war veteran\u2019s card, buff-coloured or tricoloured), \u2014 Carte d\u2019invalidit\u00e9 civile ou militaire avec photographie (civilian or military invalidity card with photo), \u2014 Carte d\u2019identit\u00e9 de fonctionnaire de l\u2019Etat avec photographie (State civil servant\u2019s identity card with photo), \u2014 Carte d\u2019identit\u00e9 ou carte de circulation avec photographie, d\u00e9livr\u00e9e par les autorit\u00e9s militaires (identity card or free movement permit with photo, issued by the military authorities), \u2014 Permis de chasser avec photographie, d\u00e9livr\u00e9 par le repr\u00e9sentant de l\u2019Etat (hunting permit with photo, issued by the State representative), \u2014 Livret ou carnet de circulation, d\u00e9livr\u00e9 par le pr\u00e9fet en application de la loi no 69-3 du 3 janvier 1969 (traveller\u2019s movement permit, issued by the Prefect pursuant to Law No 69-3 of 3 January 1969), \u2014 R\u00e9c\u00e9piss\u00e9 valant justification de l\u2019identit\u00e9, d\u00e9livr\u00e9 en \u00e9change des pi\u00e8ces d\u2019identit\u00e9 en cas de contr\u00f4le judiciaire, en application du neuvi\u00e8me alin\u00e9a (7o) de l\u2019article 138 du code de proc\u00e9dure p\u00e9nale (receipt counting as proof of identity, issued in exchange for identity documentation in cases of judicial supervision pursuant to the ninth paragraph (numbered paragraph 7) of Article 138 of the Code of Criminal Procedure), \u2014 Attestation de d\u00e9p\u00f4t d\u2019une demande de carte nationale d\u2019identit\u00e9 ou de passeport, d\u00e9livr\u00e9e depuis moins de trois mois par une commune et comportant une photographie d\u2019identit\u00e9 du demandeur authentifi\u00e9e par un cachet de la commune (certificate of lodgement of an application for a national identity card or passport, issued not more than three months previously by a municipality and bearing a photo of the applicant authenticated by a municipal stamp). ITALY \u2014 Passaporto (passport), inclusa l\u2019indicazione dell\u2019autorit\u00e0 di rilascio (including issuing authority) \u2014 Carta di identit\u00e0 (identity card), inclusa l\u2019indicazione dell\u2019autorit\u00e0 di rilascio (including issuing authority) CYPRUS \u2014 \u0394\u03b5\u03bb\u03c4\u03af\u03bf \u03a4\u03b1\u03c5\u03c4\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 (identity card of national or resident) \u2014 \u0394\u03b9\u03b1\u03b2\u03b1\u03c4\u03ae\u03c1\u03b9\u03bf (passport) LATVIA \u2014 Personas kods (personal identification number) LITHUANIA \u2014 Asmens kodas (personal number) LUXEMBOURG \u2014 Num\u00e9ro d\u2019identification national (num\u00e9ro inscrit sur la carte d\u2019identification de la S\u00e9curit\u00e9 sociale) (national identification number appearing on the social security identity card) HUNGARY \u2014 szem\u00e9lyazonos\u00edt\u00f3 igazolv\u00e1ny (identity card) \u2014 \u00fatlev\u00e9l (passport) \u2014 szem\u00e9lyi azonos\u00edt\u00f3 sz\u00e1m (szem\u00e9lyi sz\u00e1m) (personal identification number) MALTA \u2014 Karta tal-Identit\u00e0 (identity card) AUSTRIA \u2014 Reisepass (passport) \u2014 Personalausweis (identity card) POLAND \u2014 Numer ewidencyjny PESEL (PESEL identification number) PORTUGAL \u2014 Bilhete de identidade (identity card) \u2014 Passaporte (passport) \u2014 Cart\u00e3o de Cidad\u00e3o (citizen\u2019s card) ROMANIA \u2014 carte de identitate (identity card) \u2014 pasaport (passport) \u2014 certificat de inregistrare (registration certificate) \u2014 cartea de rezidenta permanenta pentru cetatenii UE (permanent residence card for EU citizens) \u2014 Cod Numeric Personal (personal identification number) SLOVENIA \u2014 Osebna izkaznica (identity card) \u2014 Potni list (passport) SWEDEN \u2014 Personnummer (personal identification number) in identity card \u2014 Personnummer (personal identification number) in passport ANNEX IV CERTIFICATE CONFIRMING THE CONFORMITY OF AN ONLINE COLLECTION SYSTEM WITH REGULATION (EU) No 211/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 FEBRUARY 2011 ON THE CITIZENS\u2019 INITIATIVE \u2026 (name of competent authority) of \u2026 (name of Member State) hereby certifies that the online collection system \u2026 (website address) used for the collection of statements of support for \u2026 (title of proposed citizens\u2019 initiative) complies with the relevant provisions of Regulation (EU) No 211/2011. Date, signature and official stamp of the competent authority: ANNEX V FORM FOR THE SUBMISSION OF STATEMENTS OF SUPPORT TO THE MEMBER STATES\u2019 COMPETENT AUTHORITIES 1. Full names, postal addresses and e-mail addresses of the contact persons: 2. Title of proposed citizens\u2019 initiative: 3. Commission registration number: 4. Date of registration: 5. Number of signatories coming from (name of Member State): 6. Annexes: (Include all statements of support from signatories to be verified by the relevant Member State. If applicable, include the relevant certificate(s) of conformity of the online collection system with Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens\u2019 initiative.) 7. Date and signature of the contact persons: ANNEX VI CERTIFICATE CONFIRMING THE NUMBER OF VALID STATEMENTS OF SUPPORT COLLECTED FOR \u2026 (NAME OF MEMBER STATE) \u2026 (name of competent authority) of \u2026 (name of Member State), having made the necessary verifications required by Article 8 of Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens\u2019 initiative, hereby certifies that \u2026 statements of support for the proposed citizens\u2019 initiative having the registration number \u2026 are valid in accordance with the provisions of that Regulation. Date, signature and official stamp of the competent authority: ANNEX VII FORM FOR THE SUBMISSION OF A CITIZENS\u2019 INITIATIVE TO THE COMMISSION 1. Title of citizens\u2019 initiative: 2. Commission registration number: 3. Date of registration: 4. Number of valid statements of support received (must be at least one million): 5. Number of signatories certified by Member States: BE BG CZ DK DE EE IE EL ES FR IT CY LV LT LU Number of signatories HU MT NL AT PL PT RO SI SK FI SE UK TOTAL Number of signatories 6. Full names, postal addresses and e-mail addresses of the contact persons (1). 7. Indicate all sources of support and funding received for the initiative, including the amount of financial support at the time of submission (1): 8. We hereby declare that the information provided in this form is correct. Date and signature of the contact persons: 9. Annexes: (Include all certificates) (1) Privacy statement: in accordance with Article 11 of Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data, data subjects are informed that these personal data are compiled by the Commission for the purpose of the procedure in respect of the citizens\u2019 initiative. Only the full names of the organisers, the e-mail addresses of the contact persons and information relating to the sources of support and funding will be made available to the public on the Commission\u2019s online register. Data subjects are entitled to object to the publication of their personal data on compelling legitimate grounds relating to their particular situation, and to request the rectification of that data at any time and its removal from the Commission\u2019s online register after the expiry of a period of two years from the date of registration of the proposed citizens\u2019 initiative.", "summary": "The citizens\u2019 initiative The citizens\u2019 initiative European Union citizens have the right of initiative under which they may invite the European Commission to propose a legal act in any field within its competence. It is the first example of transnational participatory democracy. ACT Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens\u2019 initiative. SUMMARY WHAT DOES THIS REGULATION DO? The Regulation establishes the rules and procedures governing the citizens\u2019 initiative. KEY POINTS To ensure that support is sufficiently broad, a citizens\u2019 initiative must be supported by 1 million citizens from at least a quarter of EU countries, which currently means seven countries. There is also a requirement for a minimum number of signatories from each of these countries, roughly proportionate to their respective populations (degressive proportionality). Organising a citizens\u2019 initiative To launch an initiative, citizens must form a \u2018citizens' committee\u2019 comprising at least seven members residing in at least seven EU countries. All must be old enough to vote in European Parliament elections. The initiative must be registered on the European Commission's website. If the registration criteria set out in the regulation are fulfilled, the registration is confirmed by the Commission and the organisers have 1 year to collect signatures (statements of support). Signing a citizens\u2019 initiative The same voting age requirement applies to those signing the statements of support. These statements can be completed either on paper or online if organisers have set up an online collection system. One million signatures. What\u2019s next? The Commission has 3 months to examine the initiative. During this time, the Commission meets with the organisers who also have the opportunity to present the initiative at a public hearing in the European Parliament. The Commission presents a formal response explaining what it intends to do and the reasons for that decision. It is not obliged to propose legislation. WHEN DOES THIS REGULATION APPLY? This regulation applies from 1 April 2012. Further information is available from the European Commission\u2019s European Citizens\u2019 Initiative website. REFERENCES Act Entry into force Entry into application Official Journal Regulation (EU) No 211/2011 31.3.2011 1.4.2012 OJ L 65, 11.3.2011, pp. 1-22 RELATED ACTS Commission Delegated Regulation (EU) No 268/2012 of 25 January 2012 amending Annex I of Regulation (EU) No 211/2011 of the European Parliament and of the Council on the citizens\u2019 initiative (OJ L 89, 27.3.2012, pp. 1-2). Commission Delegated Regulation (EU) No 887/2013 of 11 July 2013 replacing Annexes II and III to Regulation (EU) No 211/2011 of the European Parliament and of the Council on the citizens\u2019 initiative (OJ L 247, 18.9.2013, pp. 11-19). Communication from the Commission on the European Citizens' Initiative: \u2018Water and sanitation are a human right! Water is a public good, not a commodity!\u2019 (COM(2014) 177 final, 19.3.2014). Commission Delegated Regulation (EU) No 531/2014 of 12 March 2014 amending Annex I of Regulation (EU) No 211/2011 of the European Parliament and of the Council on the citizens\u2019 initiative (OJ L 148, 20.5.2014, pp. 52-53). Corrigendum to Commission Delegated Regulation (EU) No 887/2013 of 11 July 2013 replacing Annexes II and III to Regulation (EU) No 211/2011 of the European Parliament and of the Council on the citizens\u2019 initiative (OJ L 235, 8.8.2014, pp. 19-19). Commission Delegated Regulation (EU) 2015/1070 of 31 March 2015 amending Annexes III, V and VII of Regulation (EC) No 211/2011 of the European Parliament and of the Council on the citizens\u2019 initiative (OJ L 178, 8.7.2015, pp. 1-11). Communication from the Commission on the European Citizens' Initiative: \u2018One of us\u2019 (COM(2014) 355 final, 28.5.2014). last update 08.07.2015"}
{"article": "10.12.2009 EN Official Journal of the European Union L 324/1 REGULATION (EC) No 1185/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2009 concerning statistics on pesticides (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty, in the light of the Joint text approved by the Conciliation Committee on 10 November 2009 (2), Whereas: (1) Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (3) recognised that the impact of pesticides on human health and the environment, in particular from pesticides used in agriculture, must be reduced further. It underlined the need to achieve more sustainable use of pesticides and called for a significant overall reduction of risks and the use of pesticides consistent with the necessary crop protection. (2) In its Communication to the Council, the European Parliament and the European Economic and Social Committee entitled \u2018Towards a Thematic Strategy on the Sustainable Use of Pesticides\u2019, the Commission recognised the need for detailed, harmonised and up-to-date statistics on sales and use of pesticides at Community level. Such statistics are necessary for assessing policies of the European Union on sustainable development and for calculating relevant indicators on the risks for health and the environment related to pesticide use. (3) Harmonised and comparable Community statistics on pesticide sales and use are essential for the development and monitoring of Community legislation and policies in the context of the Thematic Strategy on the Sustainable Use of Pesticides. (4) Since the effects of the Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (4) will not become apparent until the first evaluation of active substances for use in biocidal products is finalised, neither the Commission nor most Member States currently have sufficient knowledge or experience to propose further measures regarding biocides. The scope of this Regulation should thus be limited to pesticides which are plant protection products covered by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (5), for which substantial experience already exists on data collection. (5) However, it is anticipated that, taking into account the results of the evaluation of Directive 98/8/EC and on the basis of an impact assessment, the scope of this Regulation will be extended to cover biocidal products. (6) The experience of the Commission in collecting data on sales and use of pesticides over many years has demonstrated the need to have a harmonised methodology for collecting statistics at Community level both from the stage of placing on the market and from users. Moreover, in view of the aim of calculating accurate risk indicators in accordance with the objectives of the Thematic Strategy on the Sustainable Use of Pesticides, statistics need to be detailed up to the level of the active substances. (7) Among the different data collection options evaluated in the impact assessment of the Thematic Strategy on the Sustainable Use of Pesticides, mandatory data collection was recommended as the best option because it would allow the development of accurate and reliable data on the placing on the market and use of pesticides quickly and cost-efficiently. (8) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics (6) constitutes the reference framework for the provisions of this Regulation, requiring, in particular, conformity to standards of professional independence, impartiality, objectivity, reliability, cost-effectiveness and statistical confidentiality. (9) The transmission of data subject to statistical confidentiality is governed by the rules set out in Regulation (EC) No 223/2009. Measures which are taken in accordance with that Regulation ensure the physical and logical protection of confidential data and ensure that no unlawful disclosure and non-statistical use occur when Community statistics are produced and disseminated. (10) The publication and dissemination of data collected under this Regulation is governed by the rules set out in Regulation (EC) No 223/2009. Measures which are taken in accordance with Regulation (EC) No 223/2009 ensure the physical and logical protection of confidential data and ensure that no unlawful disclosure and non-statistical use occur when Community statistics are produced and disseminated. (11) Data regarding the placing on the market and use of pesticides to be submitted pursuant to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (7) and Regulation (EC) No 1107/2009 should be assessed in accordance with the relevant provisions of that Directive and of that Regulation. (12) This Regulation should apply without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (8) and to Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (9). (13) To ensure comparable results, statistics on pesticides should be produced in accordance with a specified breakdown, in an appropriate form and within a fixed period of time from the end of a reference year as defined in the Annexes of this Regulation. (14) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (10). (15) In particular the Commission should be empowered to define the area treated and to adapt Annex III. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (16) Since the objective of this Regulation, namely the establishment of a common framework for the systematic production of Community statistics on the placing on the market and use of pesticides, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (17) The Statistical Programme Committee, established by Council Decision 89/382/EEC, Euratom (11), has been consulted, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter, scope and objectives 1. This Regulation establishes a common framework for the systematic production of Community statistics on the placing on the market and use of those pesticides which are plant protection products, as defined in Article 2(a)(i). 2. The statistics shall apply to: \u2014 the annual amounts of pesticides placed on the market in accordance with Annex I, \u2014 the annual amounts of pesticides used in accordance with Annex II, 3. The statistics shall, in particular, together with other relevant data serve the purposes of Articles 4 and 15 of Directive 2009/128/EC. Article 2 Definitions For the purposes of this Regulation, the following definitions shall apply: (a) \u2018pesticides\u2019 means: (i) a plant protection product as defined in Article 2(1) of Regulation (EC) No 1107/2009; (ii) a biocidal product as defined in Article 2(1) of Directive 98/8/EC; (b) \u2018substances\u2019 means substances as defined in point 2 of Article 3 of Regulation (EC) No 1107/2009, including active substances, safeners and synergists; (c) \u2018active substances\u2019 means active substances as referred to in Article 2(2) of Regulation (EC) No 1107/2009; (d) \u2018safeners\u2019 means safeners as referred to in Article 2(3)(a) of Regulation (EC) No 1107/2009; (e) \u2018synergists\u2019 means synergists as referred to in Article 2(3)(b) of Regulation (EC) No 1107/2009; (f) \u2018placing on the market\u2019 means placing on the market as defined in point 9 of Article 3 of Regulation (EC) No 1107/2009; (g) \u2018authorisation holder\u2019 means authorisation holder as defined in point 24 of Article 3 of Regulation (EC) No 1107/2009; (h) \u2018agricultural use\u2019 means any type of application of a plant protection product associated directly or indirectly with the production of plant products in the context of the economic activity of an agricultural holding; (i) \u2018professional user\u2019 means professional user as defined in point 1 of Article 3 of Directive 2009/128/EC; (j) \u2018agricultural holding\u2019 means agricultural holding as defined in Regulation (EC) No 1166/2008 of the European Parliament and of the Council of 19 November 2008 on farm structure surveys and the survey on agricultural production methods (12). Article 3 Data collection, transmission and processing 1. Member States shall collect the data necessary for the specification of the characteristics listed in Annex I on an annual basis and for the specification of the characteristics listed in Annex II in five-year periods by means of: \u2014 surveys, \u2014 information concerning the placing on the market and use of pesticides taking into account, in particular, the obligations pursuant to Article 67 of Regulation (EC) No 1107/2009, \u2014 administrative sources, or, \u2014 a combination of these means, including statistical estimation procedures on the basis of expert judgements or models, 2. Member States shall transmit to the Commission (Eurostat) the statistical results, including confidential data, in accordance with the schedules and with the periodicity specified in Annexes I and II. Data shall be presented in accordance with the classification given in Annex III. 3. Member States shall transmit the data in electronic form, in conformity with an appropriate technical format to be adopted by the Commission (Eurostat) in accordance with the regulatory procedure referred to in Article 6(2). 4. For reasons of confidentiality, the Commission (Eurostat) shall aggregate the data before publication in accordance with the chemical classes or categories of products indicated in Annex III, taking due account of the protection of confidential data at the level of individual Member State. The confidential data shall be used by national authorities and by the Commission (Eurostat) exclusively for statistical purposes, in accordance with Article 20 of Regulation (EC) No 223/2009. Article 4 Quality assessment 1. For the purpose of this Regulation, the quality criteria as laid down in Article 12(1) of Regulation (EC) No 223/2009 shall apply. 2. Member States shall provide the Commission (Eurostat) with reports on the quality of the data transmitted as referred to in Annexes I and II. The Commission (Eurostat) shall assess the quality of data transmitted. Article 5 Implementing measures 1. The appropriate technical format for the transmission of data shall be adopted in accordance with the regulatory procedure referred to in Article 6(2). The Commission may, if necessary, modify requirements relating to the provision of the quality reports described in Section 6 of Annexes I and II. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(3). 2. The Commission shall adopt the definition of the \u2018area treated\u2019 as referred to in Section 2 of Annex II. That measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(3). 3. The Commission shall adapt the list of substances to be covered and their classification in categories of products and chemical classes as set out in Annex III on a regular basis and at least every five years. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(3). Article 6 Committee procedure 1. The Commission shall be assisted by the European Statistical System Committee, established by Article 7 of Regulation (EC) No 223/2009. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 7 Report The Commission shall submit a report on the implementation of the Regulation to the European Parliament and the Council every five years. This report shall evaluate in particular the quality of data transmitted, as referred to in Article 4, the data collection methods, the burden on businesses, agricultural holdings and national administrations and the usefulness of these statistics in the context of the Thematic Strategy on the Sustainable Use of Pesticides in particular with regard to the objectives set out in Article 1. It shall, if appropriate, contain proposals designed to further improve data quality and data collection methods thereby improving the coverage and comparability of data and reducing the burden on businesses, agricultural holdings and national administrations. The first report shall be submitted by 31 December 2016. Article 8 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 November 2009. For the European Parliament The President J. BUZEK For the Council The President \u00c5. TORSTENSSON (1) OJ C 256, 27.10.2007, p. 86. (2) Opinion of the European Parliament of 12 March 2008 (OJ C 66 E, 20.3.2009, p. 98), Council Common Position of 20 November 2008 (OJ C 38 E, 17.2.2009, p. 1), Position of the European Parliament of 24 April 2009 (not yet published in the Official Journal), Council Decision of 16 November 2009 and Legislative Resolution of the European Parliament of 24 November 2009. (3) OJ L 242, 10.9.2002, p. 1. (4) OJ L 123, 24.4.1998, p. 1. (5) OJ L 309, 24.11.2009, p. 1. (6) OJ L 87, 31.3.2009, p. 164. (7) OJ L 309, 24.11.2009, p. 71. (8) OJ L 41, 14.2.2003, p. 26. (9) OJ L 264, 25.9.2006, p. 13. (10) OJ L 184, 17.7.1999, p. 23. (11) OJ L 181, 28.6.1989, p. 47. (12) OJ L 321, 1.12.2008, p. 14. ANNEX I STATISTICS ON THE PLACING ON THE MARKET OF PESTICIDES Section 1 Coverage The statistics shall cover substances listed in Annex III contained in pesticides placed on the market in each Member State. Special attention shall be paid to avoiding double counting in the event of product reconditioning or transfer of authorisation between authorisation holders. Section 2 Variables The quantity of each substance listed in Annex III contained in pesticides placed on the market shall be compiled in each Member State. Section 3 Reporting measure Data shall be expressed in kilograms of substances. Section 4 Reference period The reference period shall be the calendar year. Section 5 First reference period, periodicity and transmission of results 1. The first reference period is the second calendar year following 30 December 2009. 2. Member States shall supply data for every calendar year subsequent to the first reference period. They shall publish those data, in particular on the Internet, in accordance with the requirements regarding protection of statistical confidentiality as laid down in Regulation (EC) No 223/2009, with a view to providing information to the public. 3. Data shall be transmitted to the Commission (Eurostat) within 12 months of the end of the reference year. Section 6 Quality report Member States shall supply the Commission (Eurostat) with a quality report, referred to in Article 4, indicating: \u2014 the methodology used to collect data, \u2014 relevant aspects of quality according to the methodology used to collect data, \u2014 a description of estimations, aggregations and exclusion methods used, This report shall be transmitted to the Commission (Eurostat) within 15 months of the end of the reference year. ANNEX II STATISTICS ON AGRICULTURAL USE OF PESTICIDES. Section 1 Coverage 1. Statistics shall cover substances listed in Annex III contained in pesticides on each selected crop in each Member State. 2. Each Member State shall establish the selection of crops to be covered during the five-year period defined in Section 5. The selection shall be designed to be representative of the crops cultivated in the Member State and of the substances used. The selection of crops shall take into account the most relevant crops for the national action plans as referred to in Article 4 of Directive 2009/128/EC. Section 2 Variables For each selected crop the following variables shall be compiled: (a) the quantity of each substance listed in Annex III contained in pesticides used on this crop, and (b) the area treated with each substance. Section 3 Reporting measures 1. Quantities of substances used shall be expressed in kilograms. 2. Areas treated shall be expressed in hectares. Section 4 Reference period 1. The reference period shall, in principle, be a period of a maximum of 12 months covering all plant protection treatments associated directly or indirectly with the crop. 2. The reference period shall be reported as the year in which the harvest began. Section 5 First reference period, periodicity and transmission of results 1. For each five-year period, Member States shall compile statistics on the use of pesticides for each selected crop within a reference period as defined in Section 4. 2. Member States may choose the reference period at any time of the five-year period. The choice can be made independently for each selected crop. 3. The first five-year period shall start at the first calendar year following 30 December 2009. 4. Member States shall supply data for every five-year period. 5. Data shall be transmitted to the Commission (Eurostat) within 12 months of the end of each five-year period and published, in particular on the Internet, in accordance with the requirements regarding the protection of statistical confidentiality as laid down in Regulation (EC) No 223/2009, with a view to providing information to the public. Section 6 Quality report When they transmit their results, Member States shall supply the Commission (Eurostat) with a quality report, referred to in Article 4, indicating: \u2014 the design of the sampling methodology, \u2014 the methodology used to collect data, \u2014 an estimation of the relative importance of the crops covered with regard to the overall amount of pesticides used, \u2014 relevant aspects of quality according to the methodology used to collect data, \u2014 a comparison between data on pesticides used during the five-year period and pesticides placed on the market during the five corresponding years, \u2014 a summary description of the commercial non-agricultural uses of pesticides obtained in the framework of pilot studies to be led by the Commission (Eurostat), ANNEX III HARMONISED CLASSIFICATION OF SUBSTANCES MAJOR GROUPS Code Chemical Class Substances common names CAS RN (1) CIPAC (2) Categories of products Common Nomenclature Fungicides and Bactericides F0 Inorganic fungicides F1 F1.1 COPPER COMPOUNDS ALL COPPER COMPOUNDS 44 F1.1 BORDEAUX MIXTURE 8011-63-0 44 F1.1 COPPER HYDROXIDE 20427-59-2 44 F1.1 COPPER OXYCHLORIDE 1332-40-7 44 F1.1 TRIBASIC COPPER SULPHATE 1333-22-8 44 F1.1 COPPER (I) OXIDE 1319-39-1 44 F1.1 OTHER COPPER SALTS 44 F1.2 INORGANIC SULFUR SULFUR 7704-34-9 18 F1.3 OTHER INORGANIC FUNGICIDES OTHER INORGANIC FUNGICIDES Fungicides based on carbamates and dithiocarbamates F2 F2.1 CARBANILATE FUNGICIDES DIETHOFENCARB 87130-20-9 513 F2.2 CARBAMATE FUNGICIDES BENTHIAVALICARB 413615-35-7 744 F2.2 IPROVALICARB 140923-17-7 620 F2.2 PROPAMOCARB 24579-73-5 399 F2.3 DITHIOCARBAMATE FUNGICIDES MANCOZEB 8018-01-7 34 F2.3 MANEB 12427-38-2 61 F2.3 METIRAM 9006-42-2 478 F2.3 PROPINEB 12071-83-9 177 F2.3 THIRAM 137-26-8 24 F2.3 ZIRAM 137-30-4 31 Fungicides based on benzimidazoles F3 F3.1 BENZIMIDAZOLE FUNGICIDES CARBENDAZIM 10605-21-7 263 F3.1 FUBERIDAZOLE 3878-19-1 525 F3.1 THIABENDAZOLE 148-79-8 323 F3.1 THIOPHANATE-METHYL 23564-05-8 262 Fungicides based on imidazoles and triazoles F4 F4.1 CONAZOLE FUNGICIDES BITERTANOL 55179-31-2 386 F4.1 BROMUCONAZOLE 116255-48-2 680 F4.1 CYPROCONAZOLE 94361-06-5 600 F4.1 DIFENOCONAZOLE 119446-68-3 687 F4.1 DINICONAZOLE 83657-24-3 690 F4.1 EPOXICONAZOLE 106325-08-0 609 F4.1 ETRIDIAZOLE 2593-15-9 518 F4.1 FENBUCONAZOLE 114369-43-6 694 F4.1 FLUQUINCONAZOLE 136426-54-5 474 F4.1 FLUSILAZOLE 85509-19-9 435 F4.1 FLUTRIAFOL 76674-21-0 436 F4.1 HEXACONAZOLE 79983-71-4 465 F4.1 IMAZALIL (ENILCONAZOLE) 58594-72-2 335 F4.1 METCONAZOLE 125116-23-6 706 F4.1 MYCLOBUTANIL 88671-89-0 442 F4.1 PENCONAZOLE 66246-88-6 446 F4.1 PROPICONAZOLE 60207-90-1 408 F4.1 PROTHIOCONAZOLE 178928-70-6 745 F4.1 TEBUCONAZOLE 107534-96-3 494 F4.1 TETRACONAZOLE 112281-77-3 726 F4.1 TRIADIMENOL 55219-65-3 398 F4.1 TRICYCLAZOLE 41814-78-2 547 F4.1 TRIFLUMIZOLE 99387-89-0 730 F4.1 TRITICONAZOLE 131983-72-7 652 F4.2 IMIDAZOLE FUNGICIDES CYAZOFAMIDE 120116-88-3 653 F4.2 FENAMIDONE 161326-34-7 650 F4.2 TRIAZOXIDE 72459-58-6 729 Fungicides based on morpholines F5 F5.1 MORPHOLINE FUNGICIDES DIMETHOMORPH 110488-70-5 483 F5.1 DODEMORPH 1593-77-7 300 F5.1 FENPROPIMORPH 67564-91-4 427 Other fungicides F6 F6.1 ALIPHATIC NITROGEN FUNGICIDES CYMOXANIL 57966-95-7 419 F6.1 DODINE 2439-10-3 101 F6.1 GUAZATINE 108173-90-6 361 F6.2 AMIDE FUNGICIDES BENALAXYL 71626-11-4 416 F6.2 BOSCALID 188425-85-6 673 F6.2 FLUTOLANIL 66332-96-5 524 F6.2 MEPRONIL 55814-41-0 533 F6.2 METALAXYL 57837-19-1 365 F6.2 METALAXYL-M 70630-17-0 580 F6.2 PROCHLORAZ 67747-09-5 407 F6.2 SILTHIOFAM 175217-20-6 635 F6.2 TOLYLFLUANID 731-27-1 275 F6.2 ZOXAMIDE 156052-68-5 640 F6.3 ANILIDE FUNGICIDES CARBOXIN 5234-68-4 273 F6.3 FENHEXAMID 126833-17-8 603 F6.4 ANTIBIOTIC FUNGICIDES-BACTERICIDES KASUGAMYCIN 6980-18-3 703 F6.4 POLYOXINS 11113-80-7 710 F6.4 STREPTOMYCIN 57-92-1 312 F6.5 AROMATIC FUNGICIDES CHLOROTHALONIL 1897-45-6 288 F6.5 DICLORAN 99-30-9 150 F6.6 DICARBOXIMIDE FUNGICIDES IPRODIONE 36734-19-7 278 F6.6 PROCYMIDONE 32809-16-8 383 F6.7 DINITROANILINE FUNGICIDES FLUAZINAM 79622-59-6 521 F6.8 DINITROPHENOL FUNGICIDES DINOCAP 39300-45-3 98 F6.9 ORGANOPHOSPHORUS FUNGICIDES FOSETYL 15845-66-6 384 F6.9 TOLCLOFOS-METHYL 57018-04-9 479 F6.10 OXAZOLE FUNGICIDES HYMEXAZOL 10004-44-1 528 F6.10 FAMOXADONE 131807-57-3 594 F6.10 VINCLOZOLIN 50471-44-8 280 F6.11 PHENYLPYRROLE FUNGICIDES FLUDIOXONIL 131341-86-1 522 F6.12 PHTHALIMIDE FUNGICIDES CAPTAN 133-06-2 40 F6.12 FOLPET 133-07-3 75 F6.13 PYRIMIDINE FUNGICIDES BUPIRIMATE 41483-43-6 261 F6.13 CYPRODINIL 121552-61-2 511 F6.13 FENARIMOL 60168-88-9 380 F6.13 MEPANIPYRIM 110235-47-7 611 F6.13 PYRIMETHANIL 53112-28-0 714 F6.14 QUINOLINE FUNGICIDES QUINOXYFEN 124495-18-7 566 F6.14 8-HYDROXYQUINOLINE SULFATE 134-31-6 677 F6.15 QUINONE FUNGICIDES DITHIANON 3347-22-6 153 F6.16 STROBILURINE FUNGICIDES AZOXYSTROBIN 131860-33-8 571 F6.16 DIMOXYSTROBIN 149961-52-4 739 F6.16 FLUOXASTROBIN 361377-29-9 746 F6.16 KRESOXIM-METHYL 143390-89-0 568 F6.16 PICOXYSTROBINE 117428-22-5 628 F6.16 PYRACLOSTROBINE 175013-18-0 657 F6.16 TRIFLOXYSTROBINE 141517-21-7 617 F6.17 UREA FUNGICIDES PENCYCURON 66063-05-6 402 F6.18 UNCLASSIFIED FUNGICIDES ACIBENZOLAR 126448-41-7 597 F6.18 BENZOIC ACID 65-85-0 622 F6.18 DICHLOROPHEN 97-23-4 325 F6.18 FENPROPIDIN 67306-00-7 520 F6.18 METRAFENONE 220899-03-6 752 F6.18 2-PHENYPHENOL 90-43-7 246 F6.18 SPIROXAMINE 118134-30-8 572 F6.19 OTHER FUNGICIDES OTHER FUNGICIDES Herbicides. Haulm Destructors and Moss Killers H0 Herbicides based on phenoxy-phytohormones H1 H1.1 PHENOXY HERBICIDES 2,4-D 94-75-7 1 H1.1 2,4-DB 94-82-6 83 H1.1 DICHLORPROP-P 15165-67-0 476 H1.1 MCPA 94-74-6 2 H1.1 MCPB 94-81-5 50 H1.1 MECOPROP 7085-19-0 51 H1.1 MECOPROP-P 16484-77-8 475 Herbicides based on triazines and triazinones H2 H2.1 METHYLTHIOTRIAZINE HERBICIDES METHOPROTRYNE 841-06-5 94 H2.2 TRIAZINE HERBICIDES SIMETRYN 1014-70-6 179 H2.2 TERBUTHYLAZINE 5915-41-3 234 H2.3 TRIAZINONE HERBICIDES METAMITRON 41394-05-2 381 H2.3 METRIBUZIN 21087-64-9 283 Herbicides based on amides and anilides H3 H3.1 AMIDE HERBICIDES BEFLUBUTAMID 113614-08-7 662 H3.1 DIMETHENAMID 87674-68-8 638 H3.1 FLUPOXAM 119126-15-7 8158 H3.1 ISOXABEN 82558-50-7 701 H3.1 NAPROPAMIDE 15299-99-7 271 H3.1 PETHOXAMIDE 106700-29-2 665 H3.1 PROPYZAMIDE 23950-58-5 315 H3.2 ANILIDE HERBICIDES DIFLUFENICAN 83164-33-4 462 H3.2 FLORASULAM 145701-23-1 616 H3.2 FLUFENACET 142459-58-3 588 H3.2 METOSULAM 139528-85-1 707 H3.2 METAZACHLOR 67129-08-2 411 H3.2 PROPANIL 709-98-8 205 H3.3 CHLOROACETANILIDE HERBICIDES ACETOCHLOR 34256-82-1 496 H3.3 ALACHLOR 15972-60-8 204 H3.3 DIMETHACHLOR 50563-36-5 688 H3.3 PRETILACHLOR 51218-49-6 711 H3.3 PROPACHLOR 1918-16-7 176 H3.3 S-METOLACHLOR 87392-12-9 607 Herbicides based on carbamates and bis-carbamates H4 H4.1 BIS-CARBAMATE HERBICIDES CHLORPROPHAM 101-21-3 43 H4.1 DESMEDIPHAM 13684-56-5 477 H4.1 PHENMEDIPHAM 13684-63-4 77 H4.2 CARBAMATE HERBICIDES ASULAM 3337-71-1 240 H4.2 CARBETAMIDE 16118-49-3 95 Herbicides based on dinitroaniline derivatives H5 H5.1 DINITROANILINE HERBICIDES BENFLURALIN 1861-40-1 285 H5.1 BUTRALIN 33629-47-9 504 H5.1 ETHALFLURALIN 55283-68-6 516 H5.1 ORYZALIN 19044-88-3 537 H5.1 PENDIMETHALIN 40487-42-1 357 H5.1 TRIFLURALIN 2582-09-8 183 Herbicides based on derivatives of urea. of uracil or of sulphonylurea H6 H6.1 SULFONYLUREA HERBICIDES AMIDOSULFURON 120923-37-7 515 H6.1 AZIMSULFURON 120162-55-2 584 H6.1 BENSULFURON 99283-01-9 502 H6.1 CHLORSULFURON 64902-72-3 391 H6.1 CINOSULFURON 94593-91-6 507 H6.1 ETHOXYSULFURON 126801-58-9 591 H6.1 FLAZASULFURON 104040-78-0 595 H6.1 FLUPYRSULFURON 150315-10-9 577 H6.1 FORAMSULFURON 173159-57-4 659 H6.1 IMAZOSULFURON 122548-33-8 590 H6.1 IODOSULFURON 185119-76-0 634 H6.1 MESOSULFURON 400852-66-6 663 H6.1 METSULFURON 74223-64-6 441 H6.1 NICOSULFURON 111991-09-4 709 H6.1 OXASULFURON 144651-06-9 626 H6.1 PRIMISULFURON 113036-87-6 712 H6.1 PROSULFURON 94125-34-5 579 H6.1 RIMSULFURON 122931-48-0 716 H6.1 SULFOSULFURON 141776-32-1 601 H6.1 THIFENSULFURON 79277-67-1 452 H6.1 TRIASULFURON 82097-50-5 480 H6.1 TRIBENURON 106040-48-6 546 H6.1 TRIFLUSULFURON 135990-29-3 731 H6.1 TRITOSULFURON 142469-14-5 735 H6.2 URACIL HERBICIDES LENACIL 2164-08-1 163 H6.3 UREA HERBICIDES CHLORTOLURON 15545-48-9 217 H6.3 DIURON 330-54-1 100 H6.3 FLUOMETURON 2164-17-2 159 H6.3 ISOPROTURON 34123-59-6 336 H6.3 LINURON 330-55-2 76 H6.3 METHABENZTHIAZURON 18691-97-9 201 H6.3 METOBROMURON 3060-89-7 168 H6.3 METOXURON 19937-59-8 219 Other herbicides H7 H7.1 ARYLOXYPHENOXY- PROPIONIC HERBICIDES CLODINAFOP 114420-56-3 683 H7.1 CYHALOFOP 122008-85-9 596 H7.1 DICLOFOP 40843-25-2 358 H7.1 FENOXAPROP-P 113158-40-0 484 H7.1 FLUAZIFOP-P-BUTYL 79241-46-6 395 H7.1 HALOXYFOP 69806-34-4 438 H7.1 HALOXYFOP-R 72619-32-0 526 H7.1 PROPAQUIZAFOP 111479-05-1 713 H7.1 QUIZALOFOP 76578-12-6 429 H7.1 QUIZALOFOP-P 94051-08-8 641 H7.2 BENZOFURANE HERBICIDES ETHOFUMESATE 26225-79-6 233 H7.3 BENZOIC-ACID HERBICIDES CHLORTHAL 2136-79-0 328 H7.3 DICAMBA 1918-00-9 85 H7.4 BIPYRIDYLIUM HERBICIDES DIQUAT 85-00-7 55 H7.4 PARAQUAT 4685-14-7 56 H7.5 CYCLOHEXANEDIONE HERBICIDES CLETHODIM 99129-21-2 508 H7.5 CYCLOXYDIM 101205-02-1 510 H7.5 TEPRALOXYDIM 149979-41-9 608 H7.5 TRALKOXYDIM 87820-88-0 544 H7.6 DIAZINE HERBICIDES PYRIDATE 55512-33-9 447 H7.7 DICARBOXIMIDE HERBICIDES CINIDON-ETHYL 142891-20-1 598 H7.7 FLUMIOXAZIN 103361-09-7 578 H7.8 DIPHENYL ETHER HERBICIDES ACLONIFEN 74070-46-5 498 H7.8 BIFENOX 42576-02-3 413 H7.8 NITROFEN 1836-75-5 170 H7.8 OXYFLUORFEN 42874-03-3 538 H7.9 IMIDAZOLINONE HERBICIDES IMAZAMETHABENZ 100728-84-5 529 H7.9 IMAZAMOX 114311-32-9 619 H7.9 IMAZETHAPYR 81335-77-5 700 H7.10 INORGANIC HERBICIDES AMMONIUM SULFAMATE 7773-06-0 679 H7.10 CHLORATES 7775-09-9 7 H7.11 ISOXAZOLE HERBICIDES ISOXAFLUTOLE 141112-29-0 575 H7.12 MORPHACTIN HERBICIDES FLURENOL 467-69-6 304 H7.13 NITRILE HERBICIDES BROMOXYNIL 1689-84-5 87 H7.13 DICHLOBENIL 1194-65-6 73 H7.13 IOXYNIL 1689-83-4 86 H7.14 ORGANOPHOSPHORUS HERBICIDES GLUFOSINATE 51276-47-2 437 H7.14 GLYPHOSATE 1071-83-6 284 H7.15 PHENYLPYRAZOLE HERBICIDES PYRAFLUFEN 129630-19-9 605 H7.16 PYRIDAZINONE HERBICIDES CHLORIDAZON 1698-60-8 111 H7.16 FLURTAMONE 96525-23-4 569 H7.17 PYRIDINECARBOXAMIDE HERBICIDES PICOLINAFEN 137641-05-5 639 H7.18 PYRIDINECARBOXYLIC-ACID HERBICIDES CLOPYRALID 1702-17-6 455 H7.18 PICLORAM 1918-02-1 174 H7.19 PYRIDYLOXYACETIC-ACID HERBICIDES FLUROXYPYR 69377-81-7 431 H7.19 TRICLOPYR 55335-06-3 376 H7.20 QUINOLINE HERBICIDES QUINCLORAC 84087-01-4 493 H7.20 QUINMERAC 90717-03-6 563 H7.21 THIADIAZINE HERBICIDES BENTAZONE 25057-89-0 366 H7.22 THIOCARBAMATE HERBICIDES EPTC 759-94-4 155 H7.22 MOLINATE 2212-67-1 235 H7.22 PROSULFOCARB 52888-80-9 539 H7.22 THIOBENCARB 28249-77-6 388 H7.22 TRI-ALLATE 2303-17-5 97 H7.23 TRIAZOLE HERBICIDES AMITROL 61-82-5 90 H7.24 TRIAZOLINONE HERBICIDES CARFENTRAZONE 128639-02-1 587 H7.25 TRIAZOLONE HERBICIDES PROPOXYCARBAZONE 145026-81-9 655 H7.26 TRIKETONE HERBICIDES MESOTRIONE 104206-82-8 625 H7.26 SULCOTRIONE 99105-77-8 723 H7.27 UNCLASSIFIED HERBICIDES CLOMAZONE 81777-89-1 509 H7.27 FLUROCHLORIDONE 61213-25-0 430 H7.27 QUINOCLAMINE 2797-51-5 648 H7.27 METHAZOLE 20354-26-1 369 H7.27 OXADIARGYL 39807-15-3 604 H7.27 OXADIAZON 19666-30-9 213 H7.27 OTHER HERBICIDES HAULM DESTRUCTOR MOSS KILLER OTHER HERBICIDES HAULM DESTRUCTOR MOSS KILLER Insecticides and Acaricides I0 Insecticides based on pyrethroids I1 I1.1 PYRETHROID INSECTICIDES ACRINATHRIN 101007-06-1 678 I1.1 ALPHA-CYPERMETHRIN 67375-30-8 454 I1.1 BETA-CYFLUTHRIN 68359-37-5 482 I1.1 BETA-CYPERMETHRIN 65731-84-2 632 I1.1 BIFENTHRIN 82657-04-3 415 I1.1 CYFLUTHRIN 68359-37-5 385 I1.1 CYPERMETHRIN 52315-07-8 332 I1.1 DELTAMETHRIN 52918-63-5 333 I1.1 ESFENVALERATE 66230-04-4 481 I1.1 ETOFENPROX 80844-07-1 471 I1.1 GAMMA-CYHALOTHRIN 76703-62-3 768 I1.1 LAMBDA-CYHALOTHRIN 91465-08-6 463 I1.1 TAU-FLUVALINATE 102851-06-9 432 I1.1 TEFLUTHRIN 79538-32-2 451 I1.1 ZETA-CYPERMETHRIN 52315-07-8 733 Insecticides based on chlorinated hydrocarbons I2 I2.1 ORGANOCHLORINE INSECTICIDES DICOFOL 115-32-2 123 I2.1 TETRASUL 2227-13-6 114 Insecticides based on carbamates and oxime-carbamate I3 I3.1 OXIME-CARBAMATE INSECTICIDES METHOMYL 16752-77-5 264 I3.1 OXAMYL 23135-22-0 342 I3.2 CARBAMATE INSECTICIDES BENFURACARB 82560-54-1 501 I3.2 CARBARYL 63-25-2 26 I3.2 CARBOFURAN 1563-66-2 276 I3.2 CARBOSULFAN 55285-14-8 417 I3.2 FENOXYCARB 79127-80-3 425 I3.2 FORMETANATE 22259-30-9 697 I3.2 METHIOCARB 2032-65-7 165 I3.2 PIRIMICARB 23103-98-2 231 Insecticides based on organophosphates I4 I4.1 ORGANOPHOSPHORUS INSECTICIDES AZINPHOS-METHYL 86-50-0 37 I4.1 CADUSAFOS 95465-99-9 682 I4.1 CHLORPYRIFOS 2921-88-2 221 I4.1 CHLORPYRIFOS-METHYL 5589-13-0 486 I4.1 COUMAPHOS 56-72-4 121 I4.1 DIAZINON 333-41-5 15 I4.1 DICHLORVOS 62-73-7 11 I4.1 DIMETHOATE 60-51-5 59 I4.1 ETHOPROPHOS 13194-48-4 218 I4.1 FENAMIPHOS 22224-92-6 692 I4.1 FENITROTHION 122-14-5 35 I4.1 FOSTHIAZATE 98886-44-3 585 I4.1 ISOFENPHOS 25311-71-1 412 I4.1 MALATHION 121-75-5 12 I4.1 METHAMIDOPHOS 10265-92-6 355 I4.1 NALED 300-76-5 195 I4.1 OXYDEMETON-METHYL 301-12-2 171 I4.1 PHOSALONE 2310-17-0 109 I4.1 PHOSMET 732-11-6 318 I4.1 PHOXIM 14816-18-3 364 I4.1 PIRIMIPHOS-METHYL 29232-93-7 239 I4.1 TRICHLORFON 52-68-6 68 Biological and botanical product based insecticides I5 I5.1 BIOLOGICAL INSECTICIDES AZADIRACHTIN 11141-17-6 627 I5.1 NICOTINE 54-11-5 8 I5.1 PYRETHRINS 8003-34-7 32 I5.1 ROTENONE 83-79-4 671 Other insecticides I6 I6.1 INSECTICIDES PRODUCED BY FERMENTATION ABAMECTIN 71751-41-2 495 I6.1 MILBEMECTIN 51596-10-2 51 596-11-3 660 I6.1 SPINOSAD 168316-95-8 636 I6.3 BENZOYLUREA INSECTICIDES DIFLUBENZURON 35367-38-5 339 I6.3 FLUFENOXURON 101463-69-8 470 I6.3 HEXAFLUMURON 86479-06-3 698 I6.3 LUFENURON 103055-07-8 704 I6.3 NOVALURON 116714-46-6 672 I6.3 TEFLUBENZURON 83121-18-0 450 I6.3 TRIFLUMURON 64628-44-0 548 I6.4 CARBAZATE INSECTICIDES BIFENAZATE 149877-41-8 736 I6.5 DIAZYLHYDRAZINE INSECTICIDES METHOXYFENOZIDE 161050-58-4 656 I6.5 TEBUFENOZIDE 112410-23-8 724 I6.6 INSECT GROWTH REGULATORS BUPROFEZIN 69327-76-0 681 I6.6 CYROMAZINE 66215-27-8 420 I6.6 HEXYTHIAZOX 78587-05-0 439 I6.7 INSECT PHEROMONES (E,Z)-9-DODECENYL ACETATE 35148-19-7 422 I6.8 NITROGUANIDINE INSECTICIDES CLOTHIANIDIN 210880-92-5 738 I6.8 THIAMETHOXAM 153719-23-4 637 I6.9 ORGANOTIN INSECTICIDES AZOCYCLOTIN 41083-11-8 404 I6.9 CYHEXATIN 13121-70-5 289 I6.9 FENBUTATIN OXIDE 13356-08-6 359 I6.10 OXADIAZINE INSECTICIDES INDOXACARB 173584-44-6 612 I6.11 PHENYL-ETHER INSECTICIDES PYRIPROXYFEN 95737-68-1 715 I6.12 PYRAZOLE (PHENYL-) INSECTICIDES FENPYROXIMATE 134098-61-6 695 I6.12 FIPRONIL 120068-37-3 581 I6.12 TEBUFENPYRAD 119168-77-3 725 I6.13 PYRIDINE INSECTICIDES PYMETROZINE 123312-89-0 593 I6.14 PYRIDYLMETHYLAMINE INSECTICIDES ACETAMIPRID 135410-20-7 649 I6.14 IMIDACLOPRID 138261-41-3 582 I6.14 THIACLOPRID 111988-49-9 631 I6.15 SULFITE ESTER INSECTICIDES PROPARGITE 2312-35-8 216 I6.16 TETRAZINE INSECTICIDES CLOFENTEZINE 74115-24-5 418 I6.17 TETRONIC ACID INSECTICIDES SPIRODICLOFEN 148477-71-8 737 I6.18 (CARBAMOYL-) TRIAZOLE INSECTICIDES TRIAZAMATE 112143-82-5 728 I6.19 UREA INSECTICIDES DIAFENTHIURON 80060-09-9 8097 I6.20 UNCLASSIFIED INSECTICIDES ETOXAZOLE 153233-91-1 623 I6.20 FENAZAQUIN 120928-09-8 693 I6.20 PYRIDABEN 96489-71-3 583 I6.21 OTHER INSECTICIDES-ACARICIDES OTHER INSECTICIDES-ACARICIDES Molluscicides. total: M0 Molluscicides M1 M1.1 CARBAMATE MOLLUSCICIDE THIODICARB 59669-26-0 543 M1.2 OTHER MOLLUSCICIDES FERRIC PHOSPHATE 10045-86-0 629 M1.2 METALDEHYDE 108-62-3 62 M1.2 OTHER MOLLUSCICIDES Plant Growth Regulators. total: PGR0 Physiological plant growth regulators PGR1 PGR1.1 PHYSIOLOGICAL PLANT GROWTH REGULATORS CHLORMEQUAT 999-81-5 143 PGR1.1 CYCLANILIDE 113136-77-9 586 PGR1.1 DAMINOZIDE 1596-84-5 330 PGR1.1 DIMETHIPIN 55290-64-7 689 PGR1.1 DIPHENYLAMINE 122-39-4 460 PGR1.1 ETHEPHON 16672-87-0 373 PGR1.1 ETHOXYQUIN 91-53-2 517 PGR1.1 FLORCHLORFENURON 68157-60-8 633 PGR1.1 FLURPRIMIDOL 56425-91-3 696 PGR1.1 IMAZAQUIN 81335-37-7 699 PGR1.1 MALEIC HYDRAZIDE 51542-52-0 310 PGR1.1 MEPIQUAT 24307-26-4 440 PGR1.1 1-METHYLCYCLOPROPENE 3100-04-7 767 PGR1.1 PACLOBUTRAZOL 76738-62-0 445 PGR1.1 PROHEXADIONE-CALCIUM 127277-53-6 567 PGR1.1 SODIUM 5-NITROGUAIACOLATE 67233-85-6 718 PGR1.1 SODIUM O-NITROPHENOLATE 824-39-5 720 PGR1.1 TRINEXAPAC-ETHYL 95266-40-3 8349 Anti-sprouting products PGR2 PGR2.2 ANTISPROUTING PRODUCTS CARVONE 99-49-0 602 PGR2.2 CHLORPROPHAM 101-21-3 43 Other plant growth regulators PGR3 PGR3.1 OTHER PLANT GROWTH REGULATORS OTHER PGR Other Plant Protection Products. total: ZR0 Mineral oils ZR1 ZR1.1 MINERAL OIL PETROLEUM OILS 64742-55-8 29 Vegetal oils ZR2 ZR2.1 VEGETAL OIL TAR OILS 30 Soil sterilants (incl. Nematicides) ZR3 ZR3.1 METHYL BROMIDE METHYL BROMIDE 74-83-9 128 ZR3.2 OTHER SOIL STERILANTS CHLOROPICRIN 76-06-2 298 ZR3.2 DAZOMET 533-74-4 146 ZR3.2 1.3-DICHLOROPROPENE 542-75-6 675 ZR3.2 METAM-SODIUM 137-42-8 20 ZR3.2 OTHER SOIL STERILANTS Rodenticides ZR4 ZR4.1 RODENTICIDES BRODIFACOUM 56073-10-0 370 ZR4.1 BROMADIOLONE 28772-56-7 371 ZR4.1 CHLORALOSE 15879-93-3 249 ZR4.1 CHLOROPHACINONE 3691-35-8 208 ZR4.1 COUMATETRALYL 5836-29-3 189 ZR4.1 DIFENACOUM 56073-07-5 514 ZR4.1 DIFETHIALONE 104653-34-1 549 ZR4.1 FLOCOUMAFEN 90035-08-8 453 ZR4.1 WARFARIN 81-81-2 70 ZR4.1 OTHER RODENTICIDES All other plant protection products ZR5 ZR5.1 DISINFECTANTS OTHER DISINFECTANTS ZR5.2 OTHER PLANT PROTECTION PRODUCTS OTHER PPP (1) Chemical Abstracts Service Registry Numbers. 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{"article": "24.11.2009 EN Official Journal of the European Union L 309/1 REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 37(2), Article 95 and Article 152(4)(b) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (4) provides for rules governing plant protection products and the active substances contained in those products. (2) Following the progress report presented by the Commission under Directive 91/414/EEC, the European Parliament by its Resolution of 30 May 2002 (5) and the Council in its Conclusions of 12 December 2001 asked the Commission to review Directive 91/414/EEC and identified a number of issues for the Commission to address. (3) In the light of the experience gained from the application of Directive 91/414/EEC and of recent scientific and technical developments, that Directive should be replaced. (4) By way of simplification, the new act should also repeal Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (6). (5) To simplify application of the new act and to ensure consistency throughout the Member States, it should take the form of a Regulation. (6) Plant production has a very important place in the Community. One of the most important ways of protecting plants and plant products against harmful organisms, including weeds, and of improving agricultural production is the use of plant protection products. (7) Plant protection products can however also have non-beneficial effects on plant production. Their use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorised and if incorrectly used. (8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment. (9) In order to remove as far as possible obstacles to trade in plant protection products existing due to the different levels of protection in the Member States, this Regulation should also lay down harmonised rules for the approval of active substances and the placing on the market of plant protection products, including the rules on the mutual recognition of authorisations and on parallel trade. The purpose of this Regulation is thus to increase the free movement of such products and availability of these products in the Member States. (10) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and they are not expected to have any harmful effect on human or animal health or any unacceptable effects on the environment. In order to achieve the same level of protection in all Member States, the decision on acceptability or non-acceptability of such substances should be taken at Community level on the basis of harmonised criteria. These criteria should be applied for the first approval of an active substance under this Regulation. For active substances already approved, the criteria should be applied at the time of renewal or review of their approval. (11) The development of non-animal test methods should be promoted in order to produce safety data relevant to humans and to replace animal studies currently in use. (12) In the interest of predictability, efficiency and consistency, a detailed procedure should be laid down for assessing whether an active substance can be approved. The information to be submitted by interested parties for the purposes of approval of a substance should be specified. In view of the amount of work connected with the approval procedure, it is appropriate that the evaluation of such information be performed by a Member State acting as a rapporteur for the Community. To ensure consistency in evaluation, an independent scientific review should be performed by the European Food Safety Authority established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (7) (the Authority). It should be clarified that the Authority performs a risk assessment whilst the Commission should perform the risk management role and take the final decision on an active substance. Provisions should be included to ensure the transparency of the evaluation process. (13) For ethical reasons, the assessment of an active substance or a plant protection product should not be based on tests or studies involving the deliberate administration of the active substance or plant protection product to humans with the purpose of determining a human \u2018no observed effect level\u2019 of an active substance. Similarly, toxicological studies carried out on humans should not be used to lower the safety margins for active substances or plant protection products. (14) To speed up the approval of active substances, strict deadlines should be established for the different procedural steps. (15) In the interest of safety, the approval period for active substances should be limited in time. The approval period should be proportionate to the possible risks inherent in the use of such substances. Experience gained from the actual use of plant protection products containing the substances concerned and any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken. The renewal of the approval should be for a period not exceeding 15 years. (16) The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied, or where compliance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (8) is compromised, should be provided for under certain conditions. (17) The evaluation of an active substance may reveal that it presents considerably less of a risk than other substances. In order to favour the inclusion of such a substance in plant protection products, it is appropriate to identify such substances and to facilitate the placing on the market of plant protection products containing them. Incentives should be given for the placing on the market of low-risk plant protection products. (18) Certain substances which are not predominantly used as plant protection products may be of value for plant protection, but the economic interest of applying for approval may be limited. Therefore, specific provisions should ensure that such substances, as far as their risks are acceptable, may also be approved for plant protection use. (19) Some active substances with certain properties should be identified at Community level as candidates for substitution. Member States should regularly examine plant protection products containing such active substances with the aim of replacing them by plant protection products containing active substances which require less risk mitigation or by non-chemical control or prevention methods. (20) In certain Member States non-chemical control or prevention methods, which are significantly safer for human and animal health and for the environment, have been established and generally applied for certain uses. In exceptional cases Member States should also be able to apply the comparative assessment when granting authorisation for plant protection products. (21) In addition to active substances, plant protection products may contain safeners or synergists for which similar rules should be provided. The technical rules necessary for the evaluation of such substances should be established. Substances currently on the market should only be evaluated after those rules have been established. (22) Plant protection products may also contain co-formulants. It is appropriate to provide a list of co-formulants which should not be included in plant protection products. (23) Plant protection products containing active substances can be formulated in many ways and used on a variety of plants and plant products, under different agricultural, plant health and environmental (including climatic) conditions. Authorisations for plant protection products should therefore be granted by Member States. (24) The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment should take priority over the objective of improving plant production. Therefore, it should be demonstrated, before plant protection products are placed on the market, that they present a clear benefit for plant production and do not have any harmful effect on human or animal health, including that of vulnerable groups, or any unacceptable effects on the environment. (25) In the interest of predictability, efficiency and consistency, criteria, procedures and conditions for the authorisation of plant protection products should be harmonised, account being taken of the general principles of protection of human and animal health and the environment. (26) Where the decision on approval cannot be finalised within the period provided for due to reasons not falling under the responsibility of the applicant, Member States should be able to grant the provisional authorisations for a limited period in order to facilitate the transition to the approval procedure provided for under this Regulation. In the light of the experience gained from the approval of the active substances under this Regulation, the provisions on provisional authorisations should cease to apply or be extended after the period of five years, if necessary. (27) The active substances contained in a plant protection product can be produced by different manufacturing processes, leading to differences in specifications. Such differences may have safety implications. For efficiency reasons, a harmonised procedure at Community level should be provided for the assessment of those differences. (28) Good administrative cooperation between Member States should be increased during all steps of the authorisation procedure. (29) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community. To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable. Therefore, the Community should be divided into zones with such comparable conditions in order to facilitate such mutual recognition. However, environmental or agricultural circumstances specific to the territory of one or more Member States might require that, on application, Member States recognise or amend an authorisation issued by another Member State, or refuse to authorise the plant protection product in their territory, where justified as a result of specific environmental or agricultural circumstances or where the high level of protection of both human and animal health and the environment required by this Regulation cannot be achieved. It should also be possible to impose appropriate conditions having regard to the objectives laid down in the National Action Plan adopted in accordance with Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve a sustainable use of pesticides (9). (30) The economic incentive for industry to apply for an authorisation is limited for certain uses. In order to ensure that diversification of agriculture and horticulture is not jeopardised by the lack of availability of plant protection products, specific rules should be established for minor uses. (31) Where identical plant protection products are authorised in different Member States, a simplified procedure for granting a parallel trade permit should be provided for in this Regulation, in order to facilitate the trade between Member States of such products. (32) In exceptional cases, Member States should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production or ecosystems which cannot be contained by any other reasonable means. Such temporary authorisations should be reviewed at Community level. (33) Community seeds legislation provides for free movement of seeds within the Community but does not contain a specific provision concerning seeds treated with plant protection products. Such a provision should therefore be included in this Regulation. If treated seeds constitute a serious risk to human or animal health or to the environment, Member States should have the possibility of taking protective measures. (34) To promote innovation, special rules should be established permitting the use of plant protection products in experiments even where they have not yet been authorised. (35) To ensure a high level of protection of human and animal health and the environment, plant protection products should be used properly, in accordance with their authorisation, having regard to the principles of integrated pest management and giving priority to non-chemical and natural alternatives wherever possible. The Council should include in the statutory management requirement referred to in Annex III to Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers (10), the principles of integrated pest management, including good plant protection practice and non-chemical methods of plant protection and pest and crop management. (36) In addition to this Regulation and Directive 2009/128/EC, a thematic strategy on the sustainable use of pesticides was adopted. In order to achieve coherence between these instruments, the user should know from the product label where, when and under what circumstances a plant protection product may be used. (37) A system of exchange of information should be established. Member States should make available to each other, the Commission and the Authority the particulars and scientific documentation submitted in connection with applications for authorisation of plant protection products. (38) Adjuvants may be used to increase the efficacy of a plant protection product. Their placing on the market or use should be forbidden where they contain a co-formulant which has been prohibited. The technical rules necessary for the authorisation should be established. (39) Studies represent a major investment. This investment should be protected in order to stimulate research. For this reason, tests and studies, other than those involving vertebrate animals, which will be subject to obligatory data sharing, lodged by one applicant with a Member State should be protected against use by another applicant. This protection should, however, be limited in time in order to allow competition. It should also be limited to studies which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary. Business operators, in particular small and medium sized enterprises, should have the same opportunities in respect of market access. (40) The use of non-animal test methods and other risk assessment strategies should be promoted. Animal testing for the purposes of this Regulation should be minimised and tests on vertebrates should be undertaken as a last resort. In accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (11), tests on vertebrate animals must be replaced, restricted or refined. Therefore, rules should be laid down to avoid duplicative testing and duplication of tests and studies on vertebrates should be prohibited. For the purpose of developing new plant protection products, there should be an obligation to allow access to studies on vertebrates on reasonable terms and the results and the costs of tests and studies on animals should be shared. In order to allow operators to know what studies have been carried out by others, Member States should keep a list of such studies even where they are not covered by the above system of compulsory access. (41) As different rules are applied by Member States, the Commission and the Authority in relation to access to and confidentiality of documents, it is appropriate to clarify the provisions concerning access to information contained in the documents in the possession of these authorities and the confidentiality of these documents. (42) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (12) applies to the classification, packaging and labelling of plant protection products. However, to improve further the protection of users of plant protection products, of consumers of plants and plant products and of the environment, further specific rules are appropriate which take account of the specific conditions of use of plant protection products. (43) To ensure that advertisements do not mislead users of plant protection products or the public, it is appropriate to lay down rules on the advertising of those products. (44) Provisions on record-keeping and information about the use of plant protection products should be established in order to raise the level of protection of human and animal health and the environment by ensuring the traceability of potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. (45) Provisions on control and inspection arrangements with regard to the marketing and use of plant protection products should ensure correct, safe and harmonised implementation of the requirements laid down in this Regulation in order to achieve a high level of protection of both human and animal health and the environment. (46) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (13) provides for control measures for the use of plant protection products at all stages of the production of food, including record-keeping on the use of plant protection products. Similar rules on monitoring and controls relating to the storage and use of plant protection products not covered by Regulation (EC) No 882/2004 should be adopted by the Commission. The bureaucratic burden on farmers should be as limited as possible. (47) The measures provided for in this Regulation should apply without prejudice to other Community legislation, in particular Directive 2009/128/EC, Directive 2000/60/EC, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin (14) and Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms. (48) It is necessary to establish procedures for the adoption of emergency measures in situations where an approved active substance, a safener, a synergist or a plant protection product is likely to constitute a serious risk to human or animal health or the environment. (49) Member States should lay down rules on penalties applicable to infringements of this Regulation and should take the measures necessary to ensure that they are implemented. (50) General civil and criminal liability in the Member States of the manufacturer and, where applicable, of the person responsible for placing the plant protection product on the market or using it should remain applicable. (51) Member States should have the possibility of recovering the costs of the procedures associated with the application of this Regulation from those seeking to place, or placing, plant protection products or adjuvants on the market and from those applying for the approval of active substances, safeners or synergists. (52) Member States should designate the necessary national competent authorities. (53) The Commission should facilitate the application of this Regulation. Therefore, it is appropriate to provide for the necessary financial resources and the possibility of amending certain provisions of this Regulation in the light of experience or of developing technical notes for guidance. (54) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (15). (55) In particular, the Commission should be empowered to adopt harmonised methods to determine the nature and quantity of active substances, safeners and synergists, and where appropriate of relevant impurities and co-formulants, and maximum quantities of plant protection products to be released, and to adopt Regulations concerning labelling requirements, controls and rules for adjuvants, establishing a work programme for safeners and synergists, including their data requirements, postponing the expiry of the approval period, extending the date for provisional authorisations, setting the information requirements for parallel trade and on inclusion of co-formulants, as well as amendments to the Regulations on data requirements and on uniform principles for evaluation and authorisation and to the Annexes. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (56) On grounds of efficiency, the normal time limits for the regulatory procedure with scrutiny should be curtailed for the adoption of a Regulation postponing the expiry of the approval period for a period sufficient to examine the application. (57) Furthermore, it is appropriate to transfer certain current provisions set out in the Annexes to Directive 91/414/EEC into separate legal instruments to be adopted by the Commission within 18 months after the entry into force of this Regulation. Since these current provisions should be, as a first step, transferred into new legal instruments and thus be adopted without any substantial modification, the advisory procedure is the most appropriate. (58) It is also appropriate to use the advisory procedure to adopt some purely technical measures, in particular technical guidelines in view of their non-binding character. (59) Certain provisions of Directive 91/414/EEC should remain applicable during the transitional period, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and purpose 1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community. 2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and co-formulants. 3. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production. 4. The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. In particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory. Article 2 Scope 1. This Regulation shall apply to products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses: (a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products; (b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient; (c) preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives; (d) destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants; (e) checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants. These products are referred to as \u2018plant protection products\u2019. 2. This Regulation shall apply to substances, including micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as \u2018active substances\u2019. 3. This Regulation shall apply to the following: (a) substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants, referred to as \u2018safeners\u2019; (b) substances or preparations which, while showing no or only weak activity as referred to in paragraph 1, can give enhanced activity to the active substance(s) in a plant protection product, referred to as \u2018synergists\u2019; (c) substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists, referred to as \u2018co-formulants\u2019; (d) substances or preparations which consist of co-formulants or preparations containing one or more co-formulants, in the form in which they are supplied to the user and placed on the market to be mixed by the user with a plant protection product and which enhance its effectiveness or other pesticidal properties, referred to as \u2018adjuvants\u2019. Article 3 Definitions For the purposes of this Regulation, the following definitions shall apply: 1. \u2018residues\u2019 means one or more substances present in or on plants or plant products, edible animal products, drinking water or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites, breakdown or reaction products; 2. \u2018substances\u2019 means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process; 3. \u2018preparations\u2019 means mixtures or solutions composed of two or more substances intended for use as a plant protection product or as an adjuvant; 4. \u2018substance of concern\u2019 means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a plant protection product in sufficient concentration to present risks of such an effect. Such substances include, but are not limited to, substances meeting the criteria to be classified as hazardous in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (16), and present in the plant protection product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Directive 1999/45/EC; 5. \u2018plants\u2019 means live plants and live parts of plants, including fresh fruit, vegetables and seeds; 6. \u2018plant products\u2019 means products of plant origin in an unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, but excluding plants; 7. \u2018harmful organisms\u2019 means any species, strain or biotype belonging to the animal kingdom or plant kingdom or pathogenic agent injurious to plants or plant products; 8. \u2018non-chemical methods\u2019 means alternative methods to chemical pesticides for plant protection and pest management, based on agronomic techniques such as those referred to in point 1 of Annex III to Directive 2009/128/EC, or physical, mechanical or biological pest control methods; 9. \u2018placing on the market\u2019 means the holding for the purpose of sale within the Community, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves, but not the return to the previous seller. Release for free circulation into the territory of the Community shall constitute placing on the market for the purposes of this Regulation; 10. \u2018authorisation of a plant protection product\u2019 means an administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory; 11. \u2018producer\u2019 means a person who manufactures plant protection products, active substances, safeners, synergists, co-formulants or adjuvants on his own, or who contracts this manufacturing to another party, or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation; 12. \u2018letter of access\u2019 means an original document by which the owner of data protected under this Regulation agrees to the use of such data under the specific terms and conditions by the competent authority for the purpose of granting an authorisation of a plant protection product or an approval of an active substance, synergist or safener for the benefit of another applicant; 13. \u2018environment\u2019 means waters (including ground, surface, transitional, coastal and marine), sediment, soil, air, land, wild species of fauna and flora, and any interrelationship between them, and any relationship with other living organisms; 14. \u2018vulnerable groups\u2019 means persons needing specific consideration when assessing the acute and chronic health effects of plant protection products. These include pregnant and nursing women, the unborn, infants and children, the elderly and workers and residents subject to high pesticide exposure over the long term; 15. \u2018micro-organisms\u2019 means any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material; 16. \u2018genetically modified organisms\u2019 means organisms in which the genetic material has been altered within the meaning of Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (17); 17. \u2018zone\u2019 means a group of Member States as defined in Annex I. For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment the zone means all zones defined in Annex I; 18. \u2018good plant protection practice\u2019 means a practice whereby the treatments with plant protection products applied to given plants or plant products, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure acceptable efficacy with the minimum quantity necessary, taking due account of local conditions and of the possibilities for cultural and biological control; 19. \u2018good laboratory practice\u2019 means a practice as defined in point 2.1 of Annex I to Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (18); 20. \u2018good experimental practice\u2019 means a practice in accordance with the provisions of European and Mediterranean Plant Protection Organisation (EPPO) Guidelines 181 and 152; 21. \u2018data protection\u2019 means the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant; 22. \u2018rapporteur Member State\u2019 means the Member State which undertakes the task of evaluating an active substance, safener or synergist; 23. \u2018tests and studies\u2019 means investigations or experiments whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of plant protection products; 24. \u2018authorisation holder\u2019 means any natural or legal person holding an authorisation of a plant protection product; 25. \u2018professional user\u2019 means a professional user as defined in Article 3(1) of Directive 2009/128/EC; 26. \u2018minor use\u2019 means use of a plant protection product in a particular Member State on plants or plant products which are: (a) not widely grown in that Member State; or (b) widely grown, to meet an exceptional plant protection need; 27. \u2018greenhouse\u2019 means a walk-in, static, closed place of crop production with a usually translucent outer shell, which allows controlled exchange of material and energy with the surroundings and prevents release of plant protection products into the environment. For the purpose of this Regulation, closed places of plant production where the outer shell is not translucent (for example, for production of mushrooms or witloof) are also considered as greenhouses; 28. \u2018post-harvest treatment\u2019 means treatment of plants or plant products after harvest in an isolated space where no run-off is possible, for example in a warehouse; 29. \u2018biodiversity\u2019 means variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this variability may include diversity within species, between species and of ecosystems; 30. \u2018competent authority\u2019 means any authority or authorities of a Member State responsible for carrying out the tasks established under this Regulation; 31. \u2018advertisement\u2019 means a means of promoting the sale or use of plant protection products (to anyone other than the authorisation holder, the person placing the plant protection product on the market and their agents) by printed or electronic media; 32. \u2018metabolite\u2019 means any metabolite or a degradation product of an active substance, safener or synergist, formed either in organisms or in the environment. A metabolite is deemed relevant if there is a reason to assume that it has intrinsic properties comparable to the parent substance in terms of its biological target activity, or that it poses a higher or comparable risk to organisms than the parent substance or that it has certain toxicological properties that are considered unacceptable. Such a metabolite is relevant for the overall approval decision or for the definition of risk mitigation measures; 33. \u2018impurity\u2019 means any component other than the pure active substance and/or variant which is present in the technical material (including components originating from the manufacturing process or from degradation during storage). CHAPTER II ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS SECTION 1 Active substances Subsection 1 Requirements and conditions for approval Article 4 Approval criteria for active substances 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied. 2. The residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: (a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available, or on groundwater; (b) they shall not have any unacceptable effect on the environment. For residues which are of toxicological, ecotoxicological, environmental or drinking water relevance, there shall be methods in general use for measuring them. Analytical standards shall be commonly available. 3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: (a) it shall be sufficiently effective; (b) it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available; or on groundwater; (c) it shall not have any unacceptable effects on plants or plant products; (d) it shall not cause unnecessary suffering and pain to vertebrates to be controlled; (e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by the Authority to assess such effects are available: (i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use following long-range environmental transportation; (ii) its impact on non-target species, including on the ongoing behaviour of those species; (iii) its impact on biodiversity and the ecosystem. 4. The requirements of paragraphs 2 and 3 shall be evaluated in the light of uniform principles as referred to in Article 29(6). 5. For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. 6. In relation to human health, no data collected on humans shall be used to lower the safety margins resulting from tests or studies on animals. 7. By way of derogation from paragraph 1, where on the basis of documented evidence included in the application an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. This derogation shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A. Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control that serious danger to plant health in their territory. At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission. Article 5 First approval First approval shall be for a period not exceeding 10 years. Article 6 Conditions and restrictions Approval may be subject to conditions and restrictions including: (a) the minimum degree of purity of the active substance; (b) the nature and maximum content of certain impurities; (c) restrictions arising from the evaluation of the information referred to in Article 8 taking account of the agricultural, plant health and environmental, including climatic, conditions in question; (d) type of preparation; (e) manner and conditions of application; (f) submission of further confirmatory information to Member States, the Commission and the European Food Safety Authority, (the Authority), where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge; (g) designation of categories of users, such as professional and non-professional; (h) designation of areas where the use of plant protection products, including soil treatment products, containing the active substance may not be authorised or where the use may be authorised under specific conditions; (i) the need to impose risk mitigation measures and monitoring after use; (j) any other particular conditions that result from the evaluation of information made available in the context of this Regulation. Subsection 2 Approval procedure Article 7 Application 1. An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4. A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation. The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it. 2. Assessment of an application may be performed by a number of Member States together under a co-rapporteur system. 3. When submitting the application, the applicant may pursuant to Article 63 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information. Member States shall assess the confidentiality requests. Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential. 4. When submitting the application the applicant shall at the same time join a complete list of tests and studies submitted pursuant to Article 8(2) and a list of any claims for data protection pursuant to Article 59. 5. When assessing the application the rapporteur Member State may at any time consult the Authority. Article 8 Dossiers 1. The summary dossier shall include the following: (a) information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 are met; where the information submitted does not cover all zones or concern a crop which is not widely grown, justification for this approach; (b) for each point of the data requirements for the active substance, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies; (c) for each point of the data requirements for the plant protection product, the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria provided for in Article 4(2) and (3) for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that data gaps in the dossier, as provided for in paragraph 2 of this Article, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the approval; (d) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals; (e) a checklist demonstrating that the dossier provided for in paragraph 2 of this Article is complete in view of the uses applied for; (f) the reasons why the test and study reports submitted are necessary for first approval of the active substance or for amendments to the conditions of the approval; (g) where relevant, a copy of an application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information; (h) an assessment of all information submitted. 2. The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1. It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product to humans. 3. The format of the summary dossier and the complete dossier shall be established in accordance with the advisory procedure referred to in Article 79(2). 4. The data requirements referred to in paragraphs 1 and 2 shall contain the requirements for active substances and plant protection products as set out in Annexes II and III to Directive 91/414/EEC and laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 79(2) without any substantial modifications. Subsequent amendments to these Regulations shall be adopted in accordance with Article 78(1)(b). 5. Scientific peer-reviewed open literature, as determined by the Authority, on the active substance and its relevant metabolites dealing with side-effects on health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier. Article 9 Admissibility of the application 1. Within 45 days of receiving the application, the rapporteur Member State shall send the applicant a written acknowledgement, stating the date of receipt, and check whether the dossiers submitted with the application contain all the elements provided for in Article 8, using the checklist referred to in point (e) of Article 8(1). It shall also check the requests for confidentiality referred to in Article 7(3) and the complete lists of tests and studies submitted pursuant to Article 8(2). 2. Where one or more of the elements provided for in Article 8 are missing, the rapporteur Member State shall inform the applicant, setting a period for their submission. Such period shall be a maximum of 3 months. Where at the end of that period, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the other Member States and the Commission that the application is inadmissible. A new application for the same substance may be submitted at any time. 3. Where the dossiers submitted with the application contain all the elements provided for in Article 8, the rapporteur Member State shall notify the applicant, the other Member States, the Commission and the Authority of the admissibility of the application and start assessing the active substance. After receiving that notification, the applicant shall immediately forward the dossiers as provided for in Article 8 to the other Member States, the Commission and the Authority, including the information about those parts of the dossiers in respect of which confidentiality has been requested as referred to in Article 7(3). Article 10 Access to the summary dossier The Authority shall without delay make the summary dossier referred to in Article 8(1) available to the public, excluding any information in respect of which confidential treatment has been requested and justified pursuant to Article 63, unless there is an overriding public interest in its disclosure. Article 11 Draft assessment report 1. Within 12 months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority, a report, referred to as the \u2018draft assessment report\u2019, assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4. 2. The draft assessment report shall also include where relevant, a proposal to set maximum residue levels. The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. Where, pursuant to Article 4(1), the assessment establishes that the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are not satisfied, the draft assessment report shall be limited to those parts of the assessment. 3. Where the rapporteur Member State needs additional studies or information, it shall set a period in which the applicant must supply those studies or that information. In that case, the 12-month period shall be extended by the additional period granted by the rapporteur Member State. The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the rapporteur Member State. It shall inform the Commission and the Authority accordingly. Where at the end of the additional period, the applicant has not submitted the additional studies or information, the rapporteur Member State shall inform the applicant, the Commission and the Authority and shall state the missing elements in the assessment included in the draft assessment report. 4. The format of the draft assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2). Article 12 Conclusion by the Authority 1. The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant and the other Member States at the latest 30 days after its receipt. It shall ask the applicant to circulate an update of the dossier where applicable to the Member States, the Commission and the Authority. The Authority shall make the draft assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63, that certain parts of the draft assessment report be kept confidential. The Authority shall allow a period of 60 days for the submission of written comments. 2. The Authority, where appropriate shall organise a consultation of experts, including experts from the rapporteur Member State. Within 120 days of the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public. In the event of a consultation as provided for in this paragraph, the 120-day period shall be extended by 30 days. Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report. 3. Where the Authority needs additional information, it shall set a period of a maximum of 90 days for the applicant to supply it to the Member States, the Commission and the Authority. The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within 60 days after receipt of the additional information. In that case the 120-day period provided for in paragraph 2 shall be extended by a period which shall cease at the moment when the additional assessment is received by the Authority. The Authority may ask the Commission to consult a Community reference laboratory, designated pursuant to Regulation (EC) No 882/2004 for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and meets the requirements in Article 29(1)(g) of this Regulation. The applicant shall, if requested by the Community reference laboratory, provide samples and analytical standards. 4. The conclusion of the Authority shall include details concerning the evaluation procedure and the properties of the active substance concerned. 5. The Authority shall establish the format for its conclusion which shall include details concerning the evaluation procedure and the properties of the active substance concerned. 6. The time limits for the Authority\u2019s opinion on applications concerning maximum residue levels set out in Article 11 and for decisions on applications concerning maximum residue levels set out in Article 14 of Regulation (EC) No 396/2005 shall be without prejudice to the time limits laid down in this Regulation. 7. Where the conclusion of the Authority is adopted within the time limit set out in paragraph 2 of this Article, extended by any additional period set in accordance with paragraph 3, the provisions of Article 11 of Regulation (EC) No 396/2005 shall not apply and the provisions of Article 14 of that Regulation shall apply without delay. 8. Where the conclusion of the Authority is not adopted within the time limit set out in paragraph 2 of this Article, extended by any additional period set in accordance with paragraph 3, the provisions of Articles 11 and 14 of Regulation (EC) No 396/2005 shall apply without delay. Article 13 Approval Regulation 1. Within six months of receiving the conclusion from the Authority, the Commission shall present a report, referred to as \u2018the review report\u2019, and a draft Regulation to the Committee referred to in Article 79(1), taking into account the draft assessment report by the rapporteur Member State and the conclusion of the Authority. The applicant shall be given the possibility to submit comments on the review report. 2. On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that: (a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate; (b) an active substance is not approved; or (c) the conditions of the approval are amended. 3. Where the approval provides for the submission of further confirmatory information as referred to in Article 6(f), the Regulation shall provide the time limit to submit the information to the Member States, the Commission and the Authority. The rapporteur Member State shall assess the additional information and submit its assessment to the other Member States, the Commission and the Authority without delay and at the latest six months after the receipt of the additional information. 4. Approved active substances shall be included in the Regulation referred to in Article 78(3) containing the list of active substances already approved. The Commission shall maintain a list of approved active substances electronically available to the public. Subsection 3 Renewal and review Article 14 Renewal of approval 1. On application the approval of an active substance shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied. Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. Such renewal of the approval may include conditions and restrictions, as referred to in Article 6. 2. The renewal of the approval shall be for a period not exceeding 15 years. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years. Article 15 Application for renewal 1. The application provided for in Article 14 shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the approval. 2. When applying for renewal, the applicant shall identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable at the time of the last approval of the active substance or because his request is for an amended approval. The applicant shall at the same time submit a timetable of any new and ongoing studies. The applicant shall identify, giving reasons, the parts of the information submitted that he requests to be kept confidential in accordance with Article 63 and at the same time any data protection claims pursuant to Article 59. Article 16 Access to the information for renewal The Authority shall, without delay, make available to the public the information provided by the applicant under Article 15, excluding any information in respect of which confidential treatment has been requested and justified pursuant to Article 63, unless there is an overriding public interest in its disclosure. Article 17 Extension of approval period for the duration of the procedure Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application. A Regulation postponing the expiry for a period sufficient to examine the application shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(5) where an applicant could not give the three years\u2019 notice required under Article 15(1) because the active substance was included in Annex I to Directive 91/414/EEC for a duration which expired before 14 June 2014. The length of that period shall be established on the basis of the following: (a) the time needed to provide the information requested; (b) the time needed to complete the procedure; (c) where appropriate, the need to ensure the establishment of a coherent work programme, as provided for in Article 18. Article 18 Work programme The Commission may establish a work programme grouping together similar active substances setting priorities on the basis of safety concerns for human and animal health or the environment and taking into account, as far as possible, the need for an effective control and resistance management of target pest. The programme may require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a period provided for in the programme. The programme shall include the following: (a) the procedures concerning the submission and assessment of applications for renewal of approvals; (b) the necessary data to be submitted, including measures to minimise animal testing, in particular the use of non-animal test methods and intelligent testing strategies; (c) the periods for submission of such data; (d) rules on the submission of new information; (e) period for assessment and decision making; (f) the allocation of evaluation of active substances to Member States, taking into account a balance in the responsibilities and work to be done among Member States acting as rapporteurs. Article 19 Implementing measures A Regulation, adopted in accordance with the regulatory procedure referred to in Article 79(3), shall set out the provisions necessary for the implementation of the renewal procedure, including, where relevant, the implementation of a work programme, as provided for in Article 18. Article 20 Renewal Regulation 1. A Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that: (a) the approval of an active substance is renewed, subject to conditions and restrictions where appropriate; or (b) the approval of an active substance is not renewed. 2. Where the reasons for not renewing the approval do not concern the protection of health or the environment, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding six months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. The grace period for the sale and distribution shall take into account the normal period of use of the plant protection product but the total grace period shall not exceed 18 months. In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately. 3. Article 13(4) shall apply. Article 21 Review of approval 1. The Commission may review the approval of an active substance at any time. It shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised. Where, in the light of new scientific and technical knowledge it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4, or further information required in accordance with Article 6(f) has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a period for the producer to submit its comments. 2. The Commission may ask the Member States and the Authority for an opinion, or for scientific or technical assistance. The Member States may provide their comments to the Commission within three months from the date of the request. The Authority shall provide its opinion or the results of its work to the Commission within three months of the date of the request. 3. Where the Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with Article 6(f) has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3). Article 13(4) and Article 20(2) shall apply. Subsection 4 Derogations Article 22 Low-risk active substances 1. An active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years by way of derogation from Article 5, where it is considered a low-risk active substance and where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment as provided for in Article 47(1). 2. Articles 4 and 6 to 21 and point 5 of Annex II shall apply. Low-risk active substances shall be listed separately in the Regulation referred to in Article 13(4). 3. The Commission may review and if necessary specify new criteria for approving an active substance as low-risk active substance in accordance with Article 78(1)(a). Article 23 Approval criteria for basic substances 1. Basic substances shall be approved in accordance with paragraphs 2 to 6. By way of derogation from Article 5, the approval shall be for an unlimited period. For the purpose of paragraphs 2 to 6, a basic substance is an active substance which: (a) is not a substance of concern; and (b) does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; and (c) is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent; and (d) is not placed on the market as a plant protection product. For the purpose of this Regulation, an active substance which fulfils the criteria of a \u2018foodstuff\u2019 as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance. 2. By way of derogation from Article 4, a basic substance shall be approved where any relevant evaluations, carried out in accordance with other Community legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment. 3. By way of derogation from Article 7 an application for the approval of a basic substance shall be submitted by a Member State or by any interested party to the Commission. The application shall be accompanied by the following information: (a) any evaluations of its possible effects on human or animal health or the environment carried out in accordance with other Community legislation regulating the use of the substance; and (b) other relevant information on its possible effects on human or animal health or the environment. 4. The Commission shall ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the date of the request. 5. Articles 6 and 13 shall apply. Basic substances shall be listed separately in the Regulation referred to in Article 13(4). 6. The Commission may review the approval of a basic substance at any time. It may take into account the request of a Member State to review the approval. Where the Commission considers that there are indications that the substance no longer satisfies the criteria provided for in paragraphs 1 to 3 it shall inform the Member States, the Authority and the interested party, setting a period for their comments to be submitted. The Commission shall ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within three months of the date of the request. Where the Commission concludes that the criteria referred to in paragraph 1 are no longer satisfied, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3). Article 24 Candidates for substitution 1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years. 2. Without prejudice to paragraph 1, Articles 4 to 21 shall apply. Candidates for substitution shall be listed separately in the Regulation referred to in Article 13(4). SECTION 2 Safeners and synergists Article 25 Approval of safeners and synergists 1. A safener or synergist shall be approved, where it complies with Article 4. 2. Articles 5 to 21 shall apply. 3. Similar data requirements to those referred to in Article 8(4) shall be defined for safeners and synergists in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). Article 26 Safeners and synergists already on the market By 14 December 2014, a Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4) establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force. The Regulation shall include the establishment of data requirements, including measures to minimise animal testing, notification, evaluation, assessment and decision-making procedures. It shall require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a specified period. SECTION 3 Unacceptable co-formulants Article 27 Co-formulants 1. A co-formulant shall not be accepted for inclusion in a plant protection product where it has been established that: (a) its residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; or (b) its use, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment. 2. Co-formulants which are not accepted for inclusion in a plant protection product pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). 3. The Commission may review co-formulants at any time. It may take into account relevant information provided by Member States. 4. Article 81(2) shall apply. 5. Detailed rules for the implementation of this Article may be established in accordance with the regulatory procedure referred to in Article 79(3). CHAPTER III PLANT PROTECTION PRODUCTS SECTION 1 Authorisation Subsection 1 Requirements and contents Article 28 Authorisation for placing on the market and use 1. A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation. 2. By way of derogation from paragraph 1, no authorisation shall be required in the following cases: (a) use of products containing exclusively one or more basic substances; (b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 54; (c) production, storage or movement of a plant protection product intended for use in another Member State, provided that the product is authorised in that Member State and that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is not used in its territory; (d) production, storage or movement of a plant protection product intended for use in a third country provided that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is exported from its territory; (e) placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52. Article 29 Requirements for the authorisation for placing on the market 1. Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 it complies with the following requirements: (a) its active substances, safeners and synergists have been approved; (b) where its active substance, safener or synergist is produced by a different source, or by the same source with a change in the manufacturing process and/or manufacturing location: (i) the specification, pursuant to Article 38, does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist; and (ii) the active substance, safener or synergist has no more harmful effects within the meaning of Article 4(2) and (3) due to its impurities than if it had been produced in accordance with the manufacturing process specified in the dossier that supported the approval; (c) its co-formulants are not included in Annex III; (d) its technical formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product; (e) in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3); (f) the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally relevant impurities and co-formulants can be determined by appropriate methods; (g) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use in all Member States, with appropriate limits of determination on relevant samples; (h) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product; (i) for plants or plant products to be used as feed or food, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005. 2. The applicant shall demonstrate that the requirements provided for in points (a) to (h) of paragraph 1 are met. 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. 4. With respect to point (f) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). 5. Article 81 shall apply. 6. Uniform principles for evaluation and authorisation of plant protection products shall contain the requirements set out in Annex VI to Directive 91/414/EEC and shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 79(2) without any substantial modifications. Subsequent amendments to these Regulations shall be adopted in accordance with Article 78(1)(c). Following these principles, interaction between the active substance, safeners, synergists and co-formulants shall be taken into account in the evaluation of plant protection products. Article 30 Provisional authorisations 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding 3 years, the placing on the market of plant protection products containing an active substance not yet approved, provided that: (a) the decision on approval could not be finalised within a period of 30 months from the date of admissibility of the application, extended by any additional period set in accordance with Article 9(2), Article 11(3) or Article 12(2) or (3); and (b) pursuant to Article 9 the dossier on the active substance is admissible in relation to the proposed uses; and (c) the Member State concludes that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product may be expected to satisfy the requirements of Article 29(1)(b) to (h); and (d) maximum residue levels have been established in accordance with Regulation (EC) No 396/2005. 2. In such cases the Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57(1). 3. The provisions laid down in paragraphs 1 and 2 shall apply until 14 June 2016. If necessary, that time limit may be extended in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). Article 31 Contents of authorisations 1. The authorisation shall define plants or plant products and non-agricultural areas (for example railways, public areas, storage rooms) on which and the purposes for which the plant protection product may be used. 2. The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product. Those requirements shall as a minimum include the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists. The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC. Member States may provide that authorisation holders shall classify or update the label without undue delay following any change to the classification and labelling of the plant protection product in accordance with Directive 1999/45/EC. In such cases, they shall immediately inform the competent authority thereof. 3. The requirements referred to in paragraph 2 shall also include where applicable: (a) the maximum dose per hectare in each application; (b) the period between the last application and harvest; (c) the maximum number of applications per year. 4. The requirements referred to in paragraph 2 may include the following: (a) a restriction with respect to the distribution and use of the plant protection product in order to protect the health of the distributors, users, bystanders, residents, consumers or workers concerned or the environment, taking into consideration requirements imposed by other Community provisions; such restriction shall be indicated on the label; (b) the obligation before the product is used to inform any neighbours who could be exposed to the spray drift and who have requested to be informed; (c) indications for proper use according to the principles of Integrated Pest Management referred to in Article 14 of and Annex III to Directive 2009/128/EC; (d) designation of categories of users, such as professional and non-professional; (e) the approved label; (f) the interval between applications; (g) the period between the last application and consumption of the plant product where applicable; (h) the re-entry interval; (i) the packaging size and material. Article 32 Duration 1. The period of authorisation shall be laid down in the authorisation. Without prejudice to Article 44, the duration of an authorisation shall be set for a period not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved. This period shall allow the examination as provided for in Article 43 to be carried out. 2. Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 50. Subsection 2 Procedure Article 33 Application for authorisation or amendment of an authorisation 1. An applicant who wishes to place a plant protection product on the market shall apply for an authorisation or amendment of an authorisation himself, or through a representative, to each Member State where the plant protection product is intended to be placed on the market. 2. The application shall include the following: (a) a list of intended uses in each zone as indicated in Annex I and the Member States where the applicant has made or intends to make an application; (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request; (c) where relevant, a copy of any authorisations already granted for that plant protection product in a Member State; (d) where relevant, a copy of any conclusion of the Member State assessing equivalence as referred to in Article 38(2). 3. The application shall be accompanied by the following: (a) for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product; (b) for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist; (c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals; (d) the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation; (e) where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information; (f) where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1); (g) a draft label. 4. When submitting the application, the applicant may pursuant to Article 63, request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information. The applicant shall at the same time submit the complete list of studies submitted pursuant to Article 8(2) and a list of test and study reports for which any claims for data protection pursuant to Article 59 are requested. Upon a request for access to information the Member State examining the application shall decide what information is to be kept confidential. 5. Where requested by the Member State the applicant shall submit his application in the national or official languages of that Member State or one of those languages. 6. On request, the applicant shall provide the Member State with samples of the plant protection product and analytical standards of its ingredients. Article 34 Exemption from the submission of studies 1. Applicants shall be exempted from supplying the test and study reports referred to in Article 33(3) where the Member State to which an application is made has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article 59, 61 or 62 or that any data protection period has expired. 2. However, applicants to whom paragraph 1 applies shall provide the following information: (a) all necessary data for the identification of the plant protection product including its complete composition as well as a declaration that no unacceptable co-formulants are used; (b) the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with point (b) of Article 29(1), where appropriate; (c) on the request of the concerned Member State, the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data. Article 35 Member State examining the application The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it. The Member State which will examine the application shall inform the applicant. At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload. The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application. Where an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions. Article 36 Examination for authorisation 1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of application. It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment. It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 in the same zone, where used in accordance with Article 55, and under realistic conditions of use. The Member State examining the application shall make available its assessment to the other Member States within the same zone. The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2). 2. The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32. 3. By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use. Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment. That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal. Article 37 Period for examination 1. The Member State examining the application shall decide within 12 months of receiving it whether the requirements for authorisation are met. Where the Member State needs additional information, it shall set a period for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the Member State. That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible. 2. The time limits provided for in paragraph 1 shall be suspended during the application of the procedure set out in Article 38. 3. For an application for authorisation of a plant protection product containing an active substance not yet approved, the Member State examining the application shall start the evaluation as soon as it has received the draft assessment report referred to in Article 12(1). In case the application concerns the same plant protection product and the same uses as contained in the dossier referred to in Article 8, the Member State shall decide on the application at the latest within six months of the active substance being approved. 4. The other Member States concerned shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the Member State examining the application decide on the application as referred to in Article 36(2) and (3). Article 38 Assessment of equivalence under point (b) of Article 29(1) 1. Where it is necessary to establish for an active substance, safener or synergist whether a different source or, for the same source a change of the manufacturing process and/or manufacturing location complies with point (b) of Article 29(1), this shall be assessed by the Member State which acted as rapporteur for the active substance, safener or synergist as referred to in Article 7(1) unless the Member State examining the application as referred to in Article 35 agrees to assess the equivalence. The applicant shall submit all necessary data to the Member State assessing equivalence. 2. After giving the applicant the opportunity to submit comments, which the applicant shall also communicate to the rapporteur Member State or the Member State examining the application as the case may be, the Member State assessing equivalence shall prepare a report on equivalence within 60 days from receiving the application and shall communicate the report to the Commission, the other Member States and the applicant. 3. In the case of a positive conclusion on equivalence and where no objection to this conclusion has been raised, point (b) of Article 29(1) shall be considered to be complied with. However, where a Member State examining the application does not agree with the conclusion of the rapporteur Member State or vice versa, it shall inform the applicant, the other Member States and the Commission stating its reasons. The Member States concerned shall try to reach agreement on whether point (b) of Article 29(1) is complied with. They shall provide the applicant with an opportunity to submit comments. 4. Where the Member States concerned do not reach agreement within 45 days, the Member State assessing equivalence shall submit the matter to the Commission. A decision on whether the conditions referred to in point (b) of Article 29(1) are complied with shall be adopted in accordance with the regulatory procedure referred to in Article 79(3). The 45-day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State or vice versa that it does not agree with the conclusion of the latter, in accordance with paragraph 3. Before such a decision is adopted, the Commission may ask the Authority for an opinion, or for scientific or technical assistance which shall be provided within 3 months of the request. 5. Detailed rules and procedures for the implementation of paragraphs 1 to 4 may be established in accordance with the regulatory procedure referred to in Article 79(3), after consultation of the Authority. Article 39 Reporting and exchange of information on applications for authorisation 1. Member States shall compile a file on each application. Each file shall contain the following: (a) a copy of the application; (b) a report containing information on the evaluation of and decision on the plant protection product; the format of the report shall be established in accordance with the advisory procedure referred to in Article 79(2); (c) a record of the administrative decisions taken by the Member State concerning the application and of the documentation provided for in Article 33(3) and Article 34 together with a summary of the latter; (d) the approved label, where applicable. 2. On request, Member States shall, without delay, make available to the other Member States, the Commission and the Authority a file containing the documentation provided for in points (a) to (d) of paragraph 1. 3. On request, applicants shall provide a copy of the documentation to be submitted with an application pursuant to Article 33(3) and Article 34 to Member States, the Commission and the Authority. 4. Detailed rules for the implementation of paragraphs 2 and 3 may be established in accordance with the regulatory procedure referred to in Article 79(3). Subsection 3 Mutual recognition of authorisations Article 40 Mutual recognition 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone; (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone; (c) the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs. 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply, with the consent of the authorisation holder, for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1. In that case the applicant must demonstrate that the use of such a plant protection product is of general interest for the Member State of introduction. Where the authorisation holder refuses its consent, the competent authority of the Member State concerned may accept the application, on grounds of public interest. Article 41 Authorisation 1. The Member State to which an application under Article 40 is submitted shall, having examined the application and the accompanying documents referred to in Article 42(1), as appropriate with regard to the circumstances in its territory, authorise the plant protection product concerned under the same conditions as the Member State examining the application, except where Article 36(3) applies. 2. By way of derogation from paragraph 1, the Member State may authorise the plant protection product where: (a) an authorisation under point (b) of Article 40(1) was applied for; (b) it contains a candidate of substitution; (c) Article 30 has been applied; or (d) it contains a substance approved in accordance with Article 4(7). Article 42 Procedure 1. The application shall be accompanied by the following: (a) a copy of the authorisation granted by the reference Member State as well as a translation of the authorisation into an official language of the Member State receiving the application; (b) a formal statement that the plant protection product is identical to that authorised by the reference Member State; (c) a complete or summary dossier as required in Article 33(3) when requested by the Member State; (d) an assessment report of the reference Member State containing information on the evaluation and decision on the plant protection product. 2. The Member State to which an application under Article 40 is submitted shall decide on the application within 120 days. 3. Where requested by the Member State, the applicant shall submit the application in the national or official languages of that Member State or one of those languages. Subsection 4 Renewal, withdrawal and amendment Article 43 Renewal of authorisation 1. An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met. 2. Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information: (a) a copy of the authorisation of the plant protection product; (b) any new information required as a result of amendments in data requirements or criteria; (c) evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval; (d) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein; (e) a report on the monitoring information, where the authorisation was subject to monitoring. 3. Member States shall check compliance of all plant protection products containing the active substance, safener or synergist concerned with any conditions and restrictions provided for in the Regulation renewing the approval under Article 20. The Member State referred to in Article 35 within each zone shall coordinate the compliance check and assessment of the information submitted for all Member States within that zone. 4. Guidelines on the organisation of compliance checks may be established in accordance with the advisory procedure referred to in Article 79(2). 5. Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein. 6. Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal. Article 44 Withdrawal or amendment of an authorisation 1. Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied. A Member State shall review an authorisation where it concludes that the objectives of Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved. 2. Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information. 3. The Member State shall withdraw or amend the authorisation, as appropriate, where: (a) the requirements referred to in Article 29 are not or are no longer satisfied; (b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted; (c) a condition included in the authorisation has not been met; (d) on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or (e) the authorisation holder fails to comply with the obligations resulting from this Regulation. 4. Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and the Authority. The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where the second, third or fourth subparagraphs of Article 36(3) have been applied. Article 46 shall apply where appropriate. Article 45 Withdrawal or amendment of an authorisation at the request of the authorisation holder 1. An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request. 2. Amendments may only be granted where it is established that the requirements referred to in Article 29 continue to be met. 3. Article 46 shall apply where appropriate. Article 46 Grace period Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks. Where the reasons for withdrawal, amendment or non-renewal of the authorisation are not related to the protection of human and animal health or the environment, the grace period shall be limited and shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned. Subsection 5 Special cases Article 47 Placing on the market of low-risk plant protection products 1. Where all the active substances contained in a plant protection product are low-risk active substances as referred to in Article 22, that product shall be authorised as a low-risk plant protection product provided no specific risk mitigation measures are needed following a risk assessment. This plant protection product shall also meet the following requirements: (a) the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II; (b) it does not contain a substance of concern; (c) it is sufficiently effective; (d) it does not cause unnecessary pain and suffering to vertebrates to be controlled; (e) it complies with points (b), (c) and (f) to (i) of Article 29(1). These products are referred to as \u2018low-risk plant protection products\u2019. 2. An applicant for authorisation of a low-risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall submit with the application a complete and a summary dossier for each point of the data requirements of the active substance and the plant protection product. 3. The Member State shall decide within 120 days whether to approve an application for authorisation of a low-risk plant protection product. Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the period specified shall be extended by the additional time limit granted by the Member State. The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible. 4. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply. Article 48 Placing on the market and use of plant protection products containing a genetically modified organism 1. A plant protection product which contains an organism falling within the scope of Directive 2001/18/EC shall be examined in respect of the genetic modification in accordance with that Directive, in addition to the assessment under this Chapter. An authorisation under this Regulation shall not be granted for such a plant protection product unless written consent, as referred to in Article 19 of Directive 2001/18/EC, has been granted for it. 2. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply. Article 49 Placing on the market of treated seeds 1. Member States shall not prohibit placing on the market and use of seeds treated with plant protection products authorised for that use in at least one Member State. 2. Where there are substantial concerns that treated seeds as referred to in paragraph 1 are likely to constitute a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of such treated seeds shall be taken immediately in accordance with the regulatory procedure referred to in Article 79(3). Before taking such measures the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided. 3. Articles 70 and 71 shall apply. 4. Without prejudice to other Community legislation concerning the labelling of seeds, the label and documents accompanying the treated seeds shall include the name of the plant protection product with which the seeds were treated, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Directive 1999/45/EC and risk mitigation measures set out in the authorisation for that product where appropriate. Article 50 Comparative assessment of plant protection products containing candidates for substitution 1. A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution. Member States shall not authorise or shall restrict the use of a plant protection product containing a candidate for substitution for use on a particular crop where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that: (a) for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment; (b) the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages; (c) the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism; and (d) the consequences on minor use authorisations are taken into account. 2. By way of derogation from Article 36(2) Member States may in exceptional cases also apply the provisions of paragraph 1 of this Article when evaluating an application for authorisation of a plant protection product not containing a candidate for substitution or a low-risk active substance, if a non-chemical control or prevention method exists for the same use and it is in general use in that Member State. 3. By way of derogation from paragraph 1, a plant protection product containing a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using that product in practice. Such authorisations shall be granted once for a period not exceeding five years. 4. For plant protection products containing a candidate for substitution Member States shall perform the comparative assessment provided for in paragraph 1 regularly and at the latest at renewal or amendment of the authorisation. Based on the results of that comparative assessment, Member States shall maintain, withdraw or amend the authorisation. 5. Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 4, that withdrawal or amendment shall take effect 3 years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier. 6. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply. Article 51 Extension of authorisations for minor uses 1. The authorisation holder, official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users may ask for the authorisation of a plant protection product already authorised in the Member State concerned to be extended to minor uses not yet covered by that authorisation. 2. Member States shall extend the authorisation provided that: (a) the intended use is minor in nature; (b) the conditions referred to in points (b), (d) and (e) of Article 4(3) and Article 29(1)(i) are satisfied; (c) the extension is in the public interest; and (d) the documentation and information to support the extension of use has been submitted by the persons or bodies referred to in paragraph 1, especially data on the magnitude of residues and where necessary on the risk assessment to the operator, worker and bystander. 3. Member States may take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses. 4. The extension may take the form of an amendment to the existing authorisation or may be a separate authorisation, in accordance with the administrative procedures of the Member State concerned. 5. When Member States grant an extension of authorisation for a minor use, they shall inform if necessary the authorisation holder and request him to change the labelling accordingly. Where the authorisation holder declines, the Member States shall ensure that users are fully and specifically informed as to instructions for use, by means of an official publication or an official website. The official publication or where applicable the label shall include a reference to the liability of the person using the plant protection product with respect to failures concerning the efficacy or to phytotoxicity of the product for which the minor use was granted. The minor use extension shall be separately identified in the label. 6. Extensions on the basis of this Article shall be separately identified and separate reference shall be made to liability restrictions. 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) provided that a plant protection product concerned is authorised in that Member State. Member States shall authorise such uses in accordance with the provisions of Article 41 provided that those uses are also considered minor in the Member States of application. 8. Member States shall establish and regularly update a list of minor uses. 9. By 14 December 2011, the Commission shall present a report to the European Parliament and the Council on the establishment of a European fund for minor uses, accompanied, if appropriate, by a legislative proposal. 10. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply. Article 52 Parallel trade 1. A plant protection product that is authorised in one Member State (Member State of origin) may, subject to granting a parallel trade permit, be introduced, placed on the market or used in another Member State (Member State of introduction), if this Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in its territory (reference product). The application shall be submitted to the competent authority of the Member State of introduction. 2. From receiving a complete application, a parallel trade permit shall be granted in a simplified procedure within 45 working days if the plant protection product to be introduced is identical in terms of paragraph 3. Member States shall on request provide each other with the information necessary to assess whether the products are identical within 10 working days of receiving the request. The procedure for granting a parallel trade permit is interrupted from the day the request for information is sent to the competent authority of the Member State of origin until the complete information required is delivered to the competent authority of the Member State of introduction. 3. Plant protection products shall be considered as identical to the reference products if: (a) they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process; (b) they are identical in specification and content to the active substances, safeners and synergists, and in the type of formulation; and (c) they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment. 4. The application for a parallel trade permit shall include the following information: (a) the name and registration number of the plant protection product in the Member State of origin; (b) the Member State of origin; (c) the name and address of the authorisation holder in the Member State of origin; (d) the original label and instructions for use with which the plant protection product to be introduced is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction. This competent authority may require a translation of the relevant parts of the original instructions for use; (e) the name and address of the applicant; (f) the name to be given to the plant protection product to be distributed in the Member State of introduction; (g) a draft label for the product intended to be placed on the market; (h) a sample of the product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction; (i) the name and registration number of the reference product. The information requirements may be amended or completed and further details and specific requirements shall be established in cases of application for a plant protection product for which a parallel trade permit has already been granted and in cases of an application for a plant protection product for a personal use in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). 5. A plant protection product for which a parallel trade permit has been issued shall be placed on the market and used only in accordance with the provisions of the authorisation of the reference product. To facilitate monitoring and controls the Commission shall set out specific control requirements for the product to be introduced in a Regulation referred to in Article 68. 6. The parallel trade permit shall be valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 45(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit shall expire by the date on which the authorisation of the reference product would normally have expired. 7. Without prejudice to specific provisions of this Article, Articles 44, 45, 46, and 55 and Article 56(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly. 8. Without prejudice to Article 44, a parallel trade permit may be withdrawn if the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy reasons. 9. Where the product is not identical, in terms of paragraph 3, to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 29. 10. The provisions of this Article shall not apply to plant protection products which are authorised in the Member State of origin in accordance with Article 53 or 54. 11. Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits. Subsection 6 Derogations Article 53 Emergency situations in plant protection 1. By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means. The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety. 2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request. 3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State: (a) may or may not extend the duration of the measure or repeat it; or (b) shall withdraw or amend its measure. 4. Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC. Article 54 Research and development 1. By way of derogation from Article 28, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product or involving unauthorised use of a plant protection product may be carried out if the Member State in whose territory the experiment or test is to be carried out has assessed the available data and granted a permit for trial purposes. The permit may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005. The Member State may authorise a programme of experiments or tests in advance or require a permit for each experiment or test. 2. An application shall be submitted to the Member State in whose territory the experiment or test is to be conducted, together with a dossier containing all the available data to permit an assessment of possible effects on human or animal health or the possible impact on the environment. 3. A permit for trial purposes shall not be granted for experiments or tests involving the release into the environment of a genetically modified organism unless such release has been accepted under Directive 2001/18/EC. 4. Paragraph 2 shall not apply if the Member State has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken. 5. Detailed rules for the implementation of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). SECTION 2 Use and information Article 55 Use of plant protection products Plant protection products shall be used properly. Proper use shall include the application of the principles of good plant protection practice and compliance with the conditions established in accordance with Article 31 and specified on the labelling. It shall also comply with the provisions of Directive 2009/128/EC and, in particular, with general principles of integrated pest management, as referred to in Article 14 of and Annex III to that Directive, which shall apply at the latest by 1 January 2014. Article 56 Information on potentially harmful or unacceptable effects 1. The holder of an authorisation for a plant protection product shall immediately notify the Member States that granted an authorisation of any new information concerning that plant protection product, the active substance, its metabolites, a safener, synergist or co-formulant contained in the plant protection product, which suggests that the plant protection product no longer complies with the criteria set out in Articles 29 and 4 respectively. In particular, potentially harmful effects of that plant protection product, or of residues of an active substance, its metabolites, a safener, synergist or co-formulant contained in it, on human or animal health or on groundwater, or their potentially unacceptable effects on plants or plant products or the environment shall be notified. To this end the authorisation holder shall record and report all suspected adverse reactions in humans, in animals and the environment related to the use of the plant protection product. The obligation to notify shall include relevant information on decisions or assessments by international organisations or by public bodies which authorise plant protection products or active substances in third countries. 2. The notification shall include an assessment of whether and how the new information would result in the plant protection product or the active substance, its metabolites, a safener, or synergist or co-formulant no longer complying with the requirements set out in Article 29 and Article 4 or Article 27, respectively. 3. Without prejudice to the right of Member States to adopt interim protective measures, the Member State which first granted an authorisation within each zone shall evaluate the information received and inform the other Member States, belonging to the same zone, where it decides to withdraw or amend the authorisation under Article 44. That Member State shall inform the other Member States and the Commission where it considers that the conditions of the approval of the active substance, safener or synergist contained in the plant protection product are no longer fulfilled or whether in the case of a co-formulant it has been considered unacceptable and propose that the approval be withdrawn or the conditions amended. 4. The holder of an authorisation for a plant protection product shall report annually to the competent authorities of the Member States which authorised his plant protection product if he has any information available relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment. Article 57 Obligation to keep information available 1. Member States shall keep information electronically available to the public on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least: (a) the name or business name of the holder of the authorisation and the authorisation number; (b) the trade name of the product; (c) the type of preparation; (d) the name and amount of each active substance, safener or synergist which it contains; (e) the classification, risk and safety phrases in accordance to Directive 1999/45/EC and to the Regulation referred to in Article 65; (f) the use or uses for which it is authorised; (g) the reasons for withdrawal of an authorisation if they are related to safety concerns; (h) the list of minor uses referred to in Article 51(8). 2. The information referred to in paragraph 1 shall be readily accessible and updated at least once every 3 months. 3. In accordance with the regulatory procedure referred to in Article 79(3), an authorisation information system may be set up to facilitate the application of paragraphs 1 and 2 of this Article. CHAPTER IV ADJUVANTS Article 58 Placing on the market and use of adjuvants 1. An adjuvant shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with the conditions established in the Regulation referred to in paragraph 2. 2. Detailed rules for the authorisation of adjuvants, including data requirements, notification, evaluation, assessment and decision making procedures shall be set out in a Regulation to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). 3. Article 81(3) shall apply. CHAPTER V DATA PROTECTION AND DATA SHARING Article 59 Data protection 1. Test and study reports shall benefit from data protection under the conditions laid down in this Article. The protection shall apply to test and study reports concerning the active substance, safener or synergist, adjuvants and the plant protection product as referred to in Article 8(2) when they are submitted to a Member State by an applicant for authorisation under this Regulation, (the first applicant), provided that those test and study reports were: (a) necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop; and (b) certified as compliant with the principles of good laboratory practice or of good experimental practice. Where a report is protected, it may not be used by the Member State which received it for the benefit of other applicants for authorisation of plant protection products, safeners or synergists and adjuvants, except as provided in paragraph 2 of this Article, in Article 62 or in Article 80. The period of data protection is 10 years starting at the date of first authorisation in that Member State, except as provided in paragraph 2 of this Article or in Article 62. That period is extended to 13 years for plant protection products covered by Article 47. Those periods shall be extended by 3 months for each extension of authorisation for minor uses as defined in Article 51(1), except where the extension of authorisation is based on extrapolation, if the applications for such authorisations are made by the authorisation holder at the latest 5 years after the date of the first authorisation in that Member State. The total period of data protection may in no case exceed 13 years. For plant protection products covered by Article 47 the total period of data protection may in no case exceed 15 years. The same data protection rules as for the first authorisation shall also apply to test and study reports submitted by third parties for the purpose of extension of authorisation for minor uses as referred to in Article 51(1). A study shall also be protected if it was necessary for the renewal or review of an authorisation. The period for data protection shall be 30 months. The first to fourth subparagraphs shall apply mutatis mutandis. 2. Paragraph 1 shall not apply: (a) to test and study reports for which the applicant has submitted a letter of access; or (b) where any period of data protection granted for the test and study reports concerned in relation to another plant protection product has expired. 3. Data protection under paragraph 1 shall only be granted where the first applicant has claimed data protection for test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product at the time of submitting the dossier and has provided to the Member State concerned for each test or study report the information referred to in point (f) of Article 8(1) and in point (d) of Article 33(3) as well as confirmation that a period of data protection has never been granted for the test or study report or that any period granted has not expired. Article 60 List of test and study reports 1. For each active substance, safener and synergist and adjuvant, rapporteur Member States shall prepare a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and make it available to the Member States and the Commission. 2. For each plant protection product which they authorise, Member States shall keep and make available to any interested party upon request: (a) a list of the test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; and (b) a list of test and study reports for which the applicant claimed data protection under Article 59 and any reasons submitted in accordance with that Article. 3. The lists provided for in paragraphs 1 and 2 shall include information on whether those test and study reports were certified as compliant with the principles of good laboratory practice or of good experimental practice. Article 61 General rules on avoidance of duplicative testing 1. In order to avoid duplicative testing, any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the information referred to in Article 57 to ascertain if and to whom an authorisation has already been granted for a plant protection product containing the same active substance, safener or synergist or for an adjuvant. The competent authority shall on request from the prospective applicant provide him with the list of test and study reports prepared in accordance with Article 60 for that product. The prospective applicant shall submit all data regarding the identity and impurities of the active substance he proposes to use. The enquiry shall be supported by evidence that the prospective applicant intends to apply for an authorisation. 2. The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or review thereof, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant. 3. The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 59, in a fair, transparent and non-discriminatory way. Article 62 Sharing of tests and studies involving vertebrate animals 1. Testing on vertebrate animals for the purposes of this Regulation shall be undertaken only where no other methods are available. Duplication of tests and studies on vertebrates undertaken for the purposes of this Regulation shall be avoided in accordance with paragraphs 2 to 6. 2. Member States shall not accept duplication of tests and studies on vertebrate animals or those initiated where conventional methods described in Annex II to Directive 1999/45/EC could reasonably have been used, in support of applications for authorisations. Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated. 3. The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements. 4. Where the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist, or of adjuvants cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State referred to in Article 61(1). The failure to reach agreement, as provided in paragraph 3, shall not prevent the competent authority of that Member State from using the test and study reports involving vertebrate animals for the purpose of the application of the prospective applicant. 5. By 14 December 2016, the Commission shall report on the effects of the provisions in this Regulation concerning data protection of tests and studies involving vertebrate animals. The Commission shall submit this report to the European Parliament and the Council accompanied, if necessary, by an appropriate legislative proposal. 6. The holder or holders of the relevant authorisation shall have a claim on the prospective applicant for a fair share of the costs incurred by him. The competent authority of the Member State may direct the parties involved to resolve the matter by formal and binding arbitration administered under national law. Otherwise the parties may resolve the matter through litigation in the courts of the Member States. Awards from arbitration or litigation shall have regard to the principles determined in paragraph 3 and shall be enforceable in the courts of the Member States. CHAPTER VI PUBLIC ACCESS TO INFORMATION Article 63 Confidentiality 1. A person requesting that information submitted under this Regulation is to be treated as confidential shall provide verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual. 2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned: (a) the method of manufacture; (b) the specification of impurity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant; (c) results of production batches of the active substance including impurities; (d) methods of analysis for impurities in the active substance as manufactured except for methods for impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant; (e) links between a producer or importer and the applicant or the authorisation holder; (f) information on the complete composition of a plant protection product; (g) names and addresses of persons involved in testing on vertebrate animals. 3. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (19). CHAPTER VII PACKAGING, LABELLING AND ADVERTISING OF PLANT PROTECTION PRODUCTS AND ADJUVANTS Article 64 Packaging and presentation 1. Plant protection products and adjuvants that may be mistaken for food, drink or feed shall be packaged in such a way as to minimise the likelihood of such a mistake being made. 2. Plant protection products and adjuvants available to the general public that may be mistaken for food, drink or feed shall contain components to discourage or prevent their consumption. 3. Article 9 of Directive 1999/45/EC shall also apply to plant protection products and adjuvants not covered by that Directive. Article 65 Labelling 1. The labelling of plant protection products shall include the classification, labelling and packaging requirements of Directive 1999/45/EC and shall comply with the requirements set out in a Regulation adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). That Regulation shall also contain standard phrases for special risks and safety precautions which supplement the phrases provided for by Directive 1999/45/EC. It shall incorporate the text of Article 16 of and the text of the Annexes IV and V to Directive 91/414/EEC with any necessary modifications. 2. Member States may require samples or mock-ups of the packaging and drafts of labels and leaflets to be submitted before the authorisation is granted. 3. Where a Member State considers that additional phrases are necessary to protect human or animal health or the environment, it shall notify the other Member States and the Commission forthwith and shall forward the additional phrase or phrases and the reasons for these requirements. Such phrases shall be considered for inclusion in the Regulation referred to in paragraph 1. Pending that inclusion, the Member State may require the use of the additional phrase or phrases. Article 66 Advertising 1. Plant protection products which are not authorised shall not be advertised. Every advertisement for a plant protection product shall be accompanied by the sentences \u2018Use plant protection products safely. Always read the label and product information before use\u2019. These sentences shall be easily legible and clearly distinguishable in relation to the whole advertisement. The words \u2018plant protection products\u2019 may be replaced by a more precise description of the product-type, such as fungicide, insecticide or herbicide. 2. The advertisement shall not include information in text or graphic form which could be misleading as regards possible risks to human or animal health or to the environment, such as the terms \u2018low risk\u2019, \u2018non-toxic\u2019 or \u2018harmless\u2019. Only in the case of low-risk plant protection products shall the term \u2018authorised as low-risk plant protection product in accordance with Regulation (EC) No 1107/2009\u2019 be allowed in the advertisement. It cannot be used as a claim on the label of the plant protection product. 3. Member States may prohibit or restrict the advertising of plant protection products in certain media, subject to Community law. 4. All statements used in advertising shall be technically justifiable. 5. Advertisements shall not contain any visual representation of potentially dangerous practices, such as mixing or application without sufficient protective clothing, nor any use near food or use by or in the vicinity of children. 6. Advertising or promotional material shall draw attention to the appropriate warning phrases and symbols as laid down in the labelling. CHAPTER VIII CONTROLS Article 67 Record-keeping 1. Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority. The competent authorities shall provide access to such information in accordance with applicable national or Community law. By 14 December 2012, the Commission shall present a report to the European Parliament and the Council on the costs and benefits of the traceability of information from users to retailers concerning the applications of plant protection products on agricultural products, accompanied, if necessary, by appropriate legislative proposals. 2. Producers of plant protection products shall undertake post-authorisation monitoring on the request of the competent authorities. They shall notify the competent authorities of the relevant results. 3. Authorisation holders shall provide the competent authorities of the Member States with all data relating to the volume of sales of plant protection products in accordance with Community legislation concerning statistics on plant protection products. 4. Implementing measures to ensure the uniform application of paragraphs 1, 2 and 3 may be adopted in accordance with the regulatory procedure referred to in Article 79(3). Article 68 Monitoring and controls Member States shall carry out official controls in order to enforce compliance with this Regulation. They shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the reports relate. Commission experts shall carry out general and specific audits in the Member States for purposes of verifying the official controls carried out by the Member States. A Regulation, adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4), shall set out provisions for the controls, in particular on the production, packaging, labelling, storage, transport, marketing, formulation, parallel trade and use of plant protection products. It shall also contain provisions concerning the collection of information and reporting on suspected poisonings. CHAPTER IX EMERGENCIES Article 69 Emergency measures Where it is clear that an approved active substance, safener, synergist or co-formulant or a plant protection product which has been authorised in accordance with this Regulation is likely to constitute a serious risk to human or animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of that substance or product shall be taken immediately in accordance with the regulatory procedure referred to in Article 79(3), either at the own initiative of the Commission or at the request of a Member State. Before taking such measures the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided. Article 70 Emergency measures in cases of extreme urgency By way of derogation from Article 69, the Commission may in cases of extreme urgency provisionally adopt emergency measures after consulting the Member State or Member States concerned and informing the other Member States. As soon as possible, and at the latest after 10 working days, those measures shall be confirmed, amended, revoked or extended in accordance with the regulatory procedure referred to in Article 79(3). Article 71 Other emergency measures 1. Where a Member State officially informs the Commission of the need to take emergency measures, and no action has been taken in accordance with Article 69 or 70, the Member State may adopt interim protective measures. In this event, it shall immediately inform the other Member States and the Commission. 2. Within 30 working days, the Commission shall put the matter before the Committee referred to in Article 79(1) in accordance with the regulatory procedure referred to in Article 79(3) with a view to the extension, amendment or repeal of the national interim protective measure. 3. The Member State may maintain its national interim protective measures until Community measures have been adopted. CHAPTER X ADMINISTRATIVE AND FINANCIAL PROVISIONS Article 72 Penalties The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take the measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. The Member States shall notify those rules and any subsequent amendment to the Commission without delay. Article 73 Civil and criminal liability The granting of authorisation and any other measures in conformity with this Regulation shall be without prejudice to general civil and criminal liability in the Member States of the producer and, where applicable, of the person responsible for placing the plant protection product on the market or using it. Article 74 Fees and charges 1. Member States may recover the costs associated with any work they carry out within the scope of this Regulation, by means of fees or charges. 2. Member States shall ensure that the fees or charges referred to in paragraph 1: (a) are established in a transparent manner; and (b) correspond to the actual total cost of the work involved except if it is in public interest to lower the fees or charges. The fees or charges may include a scale of fixed charges based on average costs for the work referred to in paragraph 1. Article 75 Competent authority 1. Each Member State shall designate a competent authority or authorities to carry out the obligations of the Member States laid down in this Regulation. 2. Each Member State shall designate a coordinating national authority to coordinate and ensure all the necessary contacts with applicants, other Member States, the Commission and the Authority. 3. Member States shall ensure that competent authorities have a sufficient number of suitably qualified and experienced staff so that the obligations laid down in this Regulation shall be carried out efficiently and effectively. 4. Each Member State shall give the details concerning its national competent authority or authorities to the Commission, the Authority and the coordinating national authorities of the other Member States and inform them of any modifications thereof. 5. The Commission shall publish and keep updated on its website a list of the authorities referred to in paragraphs 1 and 2. Article 76 Expenditure by the Commission 1. The Commission may incur expenditure for activities contributing to the aims of this Regulation including the organisation of the following: (a) development of a harmonised system, including an appropriate database, for gathering and storing all information concerning active substances, safeners, synergists, co-formulants, plant protection products and adjuvants and for making such information available to the Member States, producers and other interested parties; (b) performance of studies needed to prepare and develop further legislation on the placing on the market and use of plant protection products and adjuvants; (c) performance of studies needed to harmonise procedures, decision-making criteria and data requirements; (d) coordination, if necessary by electronic means, of cooperation between Member States, the Commission and the Authority and measures to facilitate work sharing; (e) development and maintenance of a coordinated electronic submission and evaluation system aimed at promoting electronic document exchange and work sharing between the applicants, the Member States, the Commission and the Authority; (f) development of guidance to facilitate the day-to-day application of this Regulation; (g) travel and subsistence expenses that Member States\u2019 experts incur as a result of the Commission appointing them to assist its experts in the framework of control activities laid down under Article 68; (h) training of control staff; (i) financing of other measures needed to ensure application of the Regulation adopted under Article 68. 2. The appropriations required under paragraph 1 shall be subject to authorisation by the budgetary authority each financial year. Article 77 Guidance documents The Commission may, in accordance with the advisory procedure referred to in Article 79(2), adopt or amend technical and other guidance documents such as explanatory notes or guidance documents on the content of the application concerning micro-organisms, pheromones and biological products, for the implementation of this Regulation. The Commission may ask the Authority to prepare or to contribute to such guidance documents. Article 78 Amendments and implementing measures 1. The following measures designed to amend non-essential elements of this Regulation, inter alia, by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4): (a) amendments to the Annexes, taking into account current scientific and technical knowledge; (b) amendments to the Regulations on data requirements for active substances and for plant protection products, as referred to in points (b) and (c) of Article 8(1), taking into account current scientific and technical knowledge; (c) amendments to the Regulation on uniform principles for evaluation and authorisation of plant protection products, as referred to in Article 29(6), taking into account current scientific and technical knowledge; (d) a Regulation postponing the expiry of the approval period referred to in the second subparagraph of Article 17; (e) a Regulation on data requirements for safeners and synergists referred to in Article 25(3); (f) a Regulation establishing a work programme for safeners and synergists referred to in Article 26; (g) adoption of the harmonised methods referred to in Article 29(4); (h) inclusion of co-formulants in Annex III, as referred to in Article 27(2); (i) extension of the date of application of this Regulation to provisional authorisations, as referred to in Article 30(3); (j) information requirements for parallel trade, as referred to in Article 52(4); (k) rules for the application of Article 54, in particular the maximum quantities of plant protection products to be released; (l) detailed rules for adjuvants, as referred to in Article 58(2); (m) a Regulation containing the requirements of the labelling of plant protection products, as referred to in Article 65(1); (n) a Regulation on controls, as referred to in the third subparagraph of Article 68. 2. Any further measures necessary for the implementation of this Regulation may be adopted in accordance with the regulatory procedure referred to in Article 79(3). 3. In accordance with the advisory procedure referred to in Article 79(2), a Regulation shall be adopted containing the list of active substances included in Annex I to Directive 91/414/EEC. Those substances shall be deemed to have been approved under this Regulation. Article 79 Committee procedure 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, as established by Article 58 of Regulation (EC) No 178/2002. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months. 4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 5. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time limits laid down in Article 5a(3)(c) and (4)(b) and (e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively. CHAPTER XI TRANSITIONAL AND FINAL PROVISIONS Article 80 Transitional measures 1. Directive 91/414/EEC shall continue to apply, with respect to the procedure and the conditions for approval: (a) to active substances for which a decision has been adopted in accordance with Article 6(3) of Directive 91/414/EEC before 14 June 2011; (b) to active substances listed in Annex I to Regulation (EC) No 737/2007 (20); (c) to active substances for which completeness has been established in accordance with Article 16 of Regulation (EC) No 33/2008 (21); (d) to active substances for which completeness has been established in accordance with Article 6 of Regulation (EC) No 33/2008 before 14 June 2011. On the basis of the examination carried out under Directive 91/414/EEC, a Regulation on the approval of such a substance shall be adopted in accordance with Article 13(2) of this Regulation. For active substances referred to in point (b) of this paragraph that approval shall not be considered as the renewal of approval referred to in Article 14 of this Regulation. 2. Article 13(1) to (4) and Annexes II and III to Directive 91/414/EEC shall continue to apply with respect to active substances included in Annex I to that Directive and to active substances approved in accordance with paragraph 1 of this Article: (a) for a period of five years from the date of their inclusion or approval, for active substances covered by Article 8(2) of Directive 91/414/EEC; (b) for a period of 10 years from the date of their inclusion or approval, for active substances which were not on the market on 26 July 1993; (c) for a period of five years from the date of the renewal of the inclusion or renewal of the approval, for active substances whose inclusion in Annex I to Directive 91/414/EEC expires by 24 November 2011. This provision shall only apply to data necessary for the renewal of the approval and which were certified as compliant with the principles of good laboratory practice by that date. 3. Where Article 13 of Directive 91/414/EEC applies by virtue of paragraph 1 or paragraph 2 of this Article, it shall be subject to any special rules concerning Directive 91/414/EEC laid down in the Act of Accession by which a Member State joined the Community. 4. For active substances for which the first approval expires by 14 December 2012, the application provided for in Article 14 shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than two years before the expiry of the first approval. 5. Applications for authorisations of plant protection products: (a) under Article 4 of Directive 91/414/EEC which are pending in the Member States; or (b) which are due to be amended or withdrawn following an inclusion in Annex I to Directive 91/414/EEC or following an approval in accordance with paragraph 1 of this Article; on 14 June 2011 shall be decided on the basis of national law in force before that date. After that decision, this Regulation shall apply. 6. Products labelled in accordance with Article 16 of Directive 91/414/EEC may continue to be placed on the market until 14 June 2015. 7. By 14 December 2013, the Commission shall establish a list of substances included in Annex I to Directive 91/414/EEC which satisfy the criteria set out in point 4 of Annex II to this Regulation and to which the provisions of Article 50 of this Regulation shall apply. Article 81 Derogation for safeners and synergists, co-formulants and adjuvants 1. By way of derogation from Article 28(1), a Member State may, for a period of 5 years following the adoption of the programme referred to in Article 26, authorise the placing on the market in its territory of plant protection products containing safeners and synergists, which have not been approved, where they are included in that programme. 2. By way of derogation from Article 27 and without prejudice to Community law, Member States may apply national provisions for co-formulants not included in Annex III until 14 June 2016. Where, after 14 June 2016, a Member State has serious grounds for considering that a co-formulant not included in Annex III is likely to constitute a serious risk to human or animal health or the environment, it may temporarily prohibit or restrict the application of a co-formulant in question within its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision. Article 71 shall apply. 3. By way of derogation from Article 58(1) Member States may apply national provisions for authorisation of adjuvants until the adoption of detailed rules referred to in Article 58(2). Article 82 Review clause By 14 December 2014, the Commission shall present a report to the European Parliament and the Council on the functioning of mutual recognition of authorisations and in particular on the application by the Member States of the provisions referred to in Article 36(3) and Article 50(2), the division of the Community into three zones and on the application of the criteria for the approval of active substances, safeners and synergists as set out in Annex II and the impact thereof on the diversification and competitiveness of agriculture as well as on human health and on the environment. The report may be accompanied, if necessary, by the appropriate legislative proposals to amend those provisions. Article 83 Repeal Without prejudice to Article 80, Directives 79/117/EEC and 91/414/EEC, as amended by the acts listed in Annex V, are repealed with effect from 14 June 2011, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in that Annex. References to the repealed Directives shall be construed as references to this Regulation. In particular, references in other Community legislation, such as Regulation (EC) No 1782/2003, to Article 3 of Directive 91/414/EEC shall be construed as references to Article 55 of this Regulation. Article 84 Entry into force and application This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. By 14 June 2011, the Commission shall adopt the following: (a) a Regulation containing the list of the active substances already approved at the moment of adoption of that Regulation; (b) a Regulation on data requirements for active substances, as referred to in Article 8(1)(b); (c) a Regulation on data requirements for plant protection products, as referred to in Article 8(1)(c); (d) a Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 36; (e) a Regulation containing the requirements of the labelling of plant protection products, as referred to in Article 65(1). This Regulation shall apply from 14 June 2011. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 21 October 2009. For the European Parliament The President J. BUZEK For the Council The President C. MALMSTR\u00d6M (1) OJ C 175, 27.7.2007, p. 44. (2) OJ C 146, 30.6.2007, p. 48. (3) Opinion of the European Parliament of 23 October 2007 (OJ C 263 E, 16.10.2008, p. 181), Council Common Position of 15 September 2008 (OJ C 266 E, 21.10.2008, p. 1) and European Parliament Position of 13 January 2009 (not yet published in the Official Journal). Council Decision of 24 September 2009. (4) OJ L 230, 19.8.1991, p. 1. (5) OJ C 187 E, 7.8.2003, p. 173. (6) OJ L 33, 8.2.1979, p. 36. (7) OJ L 31, 1.2.2002, p. 1. (8) OJ L 327, 22.12.2000, p. 1. (9) See page 71 of this Official Journal. (10) OJ L 270, 21.10.2003, p. 1. (11) OJ L 358, 18.12.1986, p. 1. (12) OJ L 200, 30.7.1999, p. 1. (13) OJ L 165, 30.4.2004, p. 1. (14) OJ L 70, 16.3.2005, p. 1. (15) OJ L 184, 17.7.1999, p. 23. (16) OJ L 353, 31.12.2008, p. 1. (17) OJ L 106, 17.4.2001, p. 1. (18) OJ L 50, 20.2.2004, p. 44. (19) OJ L 41, 14.2.2003, p. 26. (20) OJ L 169, 29.6.2007, p. 10. (21) OJ L 15, 18.1.2008, p. 5. ANNEX I Definition of zones for the authorisation of plant protection products as referred to in Article 3(17) Zone A \u2014 North The following Member States belong to this zone: Denmark, Estonia, Latvia, Lithuania, Finland, Sweden Zone B \u2014 Centre The following Member States belong to this zone: Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia, United Kingdom Zone C \u2014 South The following Member States belong to this zone: Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal ANNEX II Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II 1. Evaluation 1.1. During the process of evaluation and decision-making provided for in Articles 4 to 21, the rapporteur Member State and the Authority shall cooperate with applicants to resolve any questions on the dossier quickly or to identify at an early stage any further explanations or additional studies necessary for the evaluation of the dossier, including information to eliminate the need for a restriction of the approval, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Regulation. 1.2. The evaluation by the Authority and the rapporteur Member State must be based on scientific principles and be made with the benefit of expert advice. 1.3. During the process of evaluation and decision-making provided for in Articles 4 to 21, Member States and the Authority shall take into consideration any further guidance developed in the framework of the Standing Committee on the Food Chain and Animal Health for the purposes of refining, where relevant, the risk assessments. 2. General decision-making criteria 2.1. Article 4 shall only be considered as complied with, where, on the basis of the dossier submitted, authorisation in at least one Member State is expected to be possible for at least one plant protection product containing that active substance for at least one of the representative uses. 2.2. Submission of further information In principle an active substance, safener or synergist shall only be approved where a complete dossier is submitted. In exceptional cases an active substance, safener or synergist may be approved even though certain information is still to be submitted where: (a) the data requirements have been amended or refined after the submission of the dossier; or (b) the information is considered to be confirmatory in nature, as required to increase confidence in the decision. 2.3. Restrictions on approval Where necessary, the approval may be subject to conditions and restrictions as referred to in Article 6. Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed. 3. Criteria for the approval of an active substance 3.1. Dossier The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD). In the case of an active substance, safener or synergist for which one or more representative uses includes use on feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 7(1) shall contain the information necessary to carry out a risk assessment and for enforcement purposes. The dossier shall in particular: (a) permit any residue of concern to be defined; (b) reliably predict the residues in food and feed, including succeeding crops; (c) reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing; (d) permit a maximum residue level to be defined and to be determined by appropriate methods in general use for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals; (e) permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined. The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species. 3.2. Efficacy An active substance alone or associated with a safener or synergist shall only be approved where it has been established for one or more representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use is sufficiently effective. This requirement shall be evaluated in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6). 3.3. Relevance of metabolites Where applicable the documentation submitted shall be sufficient to permit the establishment of the toxicological, ecotoxicological or environmental relevance of metabolites. 3.4. Composition of the active substance, safener or synergist 3.4.1. The specification shall define the minimum degree of purity, the identity and maximum content of impurities and, where relevant, of isomers/diastereo-isomers and additives, and the content of impurities of toxicological, ecotoxicological or environmental concern within acceptable limits. 3.4.2. The specification shall be in compliance with the relevant Food and Agriculture Organisation specification as appropriate, where such specification exists. However, where necessary for reasons of protection of human or animal health or the environment, stricter specifications may be adopted. 3.5. Methods of analysis 3.5.1. The methods of analysis of the active substance, safener or synergist as manufactured and of determination of impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater than 1 g/kg in the active substance, safener or synergist as manufactured, shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise. 3.5.2. The methods of residue analysis for the active substance and relevant metabolites in plant, animal and environmental matrices and drinking water, as appropriate, shall have been validated and shown to be sufficiently sensitive with respect to the levels of concern. 3.5.3. The evaluation has been carried out in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6). 3.6. Impact on human health 3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population. When the critical effect is judged of particular significance, such as developmental neurotoxic or immunotoxic effects, an increased margin of safety shall be considered, and applied if necessary. 3.6.2. An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as mutagen category 1A or 1B. 3.6.3. An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. 3.6.4. An active substance, safener or synergist shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. 3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. By 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal Health a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). Pending the adoption of these criteria, substances that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered to have endocrine disrupting properties. In addition, substances such as those that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered to have such endocrine disrupting properties. 3.7. Fate and behaviour in the environment 3.7.1. An active substance, safener or synergist shall only be approved where it is not considered to be a persistent organic pollutant (POP). A substance that fulfils all three of the criteria of the points below is a POP. 3.7.1.1. Persistence An active substance, safener or synergist fulfils the persistence criterion where there is evidence that the time it takes for a degradation of 50 % (DT50) in water is greater than 2 months, or that its DT50 in soil is greater than 6 months, or that its DT50 in sediment is greater than 6 months. 3.7.1.2. Bioaccumulation An active substance, safener or synergist fulfils the bioaccumulation criterion where there is: \u2014 evidence that its bio-concentration factor or bioaccumulation factor in aquatic species is greater than 5 000 or, in the absence of such data, that the partition coefficient n-octanol/water (log Ko/w) is greater than 5, or \u2014 evidence that the active substance, safener or synergist present other reasons for concern, such as high bioaccumulation in other non-target species, high toxicity or ecotoxicity. 3.7.1.3. Potential for long-range environmental transport: An active substance, safener or synergist fulfils the potential for long-range environmental transport criterion where: \u2014 measured levels of the active substance, safener or synergist in locations distant from the sources of its release are of potential concern, \u2014 monitoring data show that long-range environmental transport of the active substance, safener or synergist, with the potential for transfer to a receiving environment, may have occurred via air, water or migratory species, or \u2014 environmental fate properties and/or model results demonstrate that the active substance, safener or synergist has a potential for long-range environmental transport through air, water or migratory species, with the potential for transfer to a receiving environment in locations distant from the sources of its release. For an active substance safener or synergist that migrates significantly through the air, its DT50 in air is to be greater than 2 days. 3.7.2. An active substance, safener or synergist shall only be approved if it is not considered to be a persistent, bioaccumulative and toxic (PBT) substance. A substance that fulfils all three of the criteria of the points below is a PBT substance. 3.7.2.1. Persistence An active substance, safener or synergist fulfils the persistence criterion where: \u2014 the half-life in marine water is higher than 60 days, \u2014 the half-life in fresh or estuarine water is higher than 40 days, \u2014 the half-life in marine sediment is higher than 180 days, \u2014 the half-life in fresh or estuarine water sediment is higher than 120 days, or \u2014 the half-life in soil is higher than 120 days. Assessment of persistency in the environment shall be based on available half-life data collected under appropriate conditions, which shall be described by the applicant. 3.7.2.2. Bioaccumulation An active substance, safener or synergist fulfils the bioaccumulation criterion where the bioconcentration factor is higher than 2 000. Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used. 3.7.2.3. Toxicity An active substance, safener or synergist fulfils the toxicity criterion where: \u2014 the long-term no-observed effect concentration for marine or freshwater organisms is less than 0,01 mg/l, \u2014 the substance is classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) pursuant to Regulation (EC) No 1272/2008, or \u2014 there is other evidence of chronic toxicity, as identified by the classifications STOT RE 1 or STOT RE 2 pursuant to Regulation (EC) No 1272/2008. 3.7.3. An active substance, safener or synergist shall only be approved if it is not considered to be a very persistent and very bioaccumulative substance (vPvB). A substance that fulfils both of the criteria of the points below is a vPvB substance. 3.7.3.1. Persistence An active substance, safener or synergist fulfils the \u2018very persistent\u2019 criterion where: \u2014 the half-life in marine, fresh- or estuarine water is higher than 60 days, \u2014 the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or \u2014 the half-life in soil is higher than 180 days. 3.7.3.2. Bioaccumulation An active substance, safener or synergist fulfils the \u2018very bioaccumulative\u2019 criterion where the bioconcentration factor is greater than 5 000. 3.8. Ecotoxicology 3.8.1. An active substance, safener or synergist shall only be approved if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6) under realistic proposed conditions of use of a plant protection product containing the active substance, safener or synergist. The assessment must take into account the severity of effects, the uncertainty of the data, and the number of organism groups which the active substance, safener or synergist is expected to affect adversely by the intended use. 3.8.2. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product under realistic proposed conditions of use is negligible. 3.8.3. An active substance, safener or synergist shall be approved only if it is established following an appropriate risk assessment on the basis of Community or internationally agreed test guidelines, that the use under the proposed conditions of use of plant protection products containing this active substance, safener or synergist: \u2014 will result in a negligible exposure of honeybees, or \u2014 has no unacceptable acute or chronic effects on colony survival and development, taking into account effects on honeybee larvae and honeybee behaviour. 3.9. Residue definition An active substance, safener or synergist shall only be approved if, where relevant, a residue definition can be established for the purposes of risk assessment and for enforcement purposes. 3.10. Fate and behaviour concerning groundwater An active substance shall only be approved where it has been established for one or more representative uses, that consequently after application of the plant protection product consistent with realistic conditions on use, the predicted concentration of the active substance or of metabolites, degradation or reaction products in groundwater complies with the respective criteria of the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6). 4. Candidate for substitution An active substance shall be approved as a candidate for substitution pursuant to Article 24 where any of the following conditions are met: \u2014 its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories, \u2014 it meets two of the criteria to be considered as a PBT substance, \u2014 there are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones), \u2014 it contains a significant proportion of non-active isomers, \u2014 it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, if the substance has not been excluded in accordance with the criteria laid down in point 3.6.3, \u2014 it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B if the substance has not been excluded in accordance with the criteria laid down in point 3.6.4, \u2014 if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, reviewed by the Authority, it is considered to have endocrine disrupting properties that may cause adverse effects in humans if the substance has not been excluded in accordance with the criteria laid down in point 3.6.5. 5. Low-risk active substances An active substance shall not be considered of low risk where it is or has to be classified in accordance with Regulation (EC) No 1272/2008 as at least one of the following: \u2014 carcinogenic, \u2014 mutagenic, \u2014 toxic to reproduction, \u2014 sensitising chemicals, \u2014 very toxic or toxic, \u2014 explosive, \u2014 corrosive. It shall also not be considered as of low risk if: \u2014 persistent (half-life in soil is more than 60 days), \u2014 bioconcentration factor is higher than 100, \u2014 it is deemed to be an endocrine disrupter, or \u2014 it has neurotoxic or immunotoxic effects. ANNEX III List of co-formulants which are not accepted for inclusion in plant protection products as referred to in Article 27 ANNEX IV Comparative assessment pursuant to Article 50 1. Conditions for comparative assessment Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protection product or a non-chemical control or prevention method is considered, referred to as \u2018substitution\u2019, the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the environment. An assessment of the alternative shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not. Further conditions for refusal or withdrawal of an authorisation are as follows: (a) substitution shall be applied only where other methods or the chemical diversity of the active substances is sufficient to minimise the occurrence of resistance in the target organism; (b) substitution shall be applied only to plant protection products where their use presents a significantly higher level of risk to human health or the environment; and (c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from use in practice, where not already available. 2. Significant difference in risk A significant difference in risk shall be identified on a case-by-case basis by the competent authorities. The properties of the active substance and plant protection product, and the possibility of exposure of different population subgroups (professional or non-professional users, bystanders, workers, residents, specific vulnerable groups or consumers) directly or indirectly through food, feed, drinking water or the environment shall be taken into account. Other factors such as the stringency of imposed restrictions on use and prescribed personal protective equipment shall also be considered. For the environment, if relevant, a factor of at least 10 for the toxicity/exposure ratio (TER) of different plant protection products is considered a significant difference in risk. 3. Significant practical or economic disadvantages Significant practical or economic disadvantage to the user is defined as a major quantifiable impairment of working practices or business activity leading to inability to maintain sufficient control of the target organism. Such a major impairment might be, for example, where no technical facilities for the use of the alternative are available or economically feasible. Where a comparative assessment indicates that restrictions on and/or prohibitions of use of a plant protection product could cause such disadvantage, then this shall be taken into account in the decision-making process. This situation shall be substantiated. The comparative assessment shall take authorised minor uses into account. ANNEX V Repealed Directives and their successive amendments as referred to in Article 83 A. Directive 91/414/EEC Acts amending Directive 91/414/EEC Deadline for transposition Directive 93/71/EEC 3 August 1994 Directive 94/37/EC 31 July 1995 Directive 94/79/EC 31 January 1996 Directive 95/35/EC 30 June 1996 Directive 95/36/EC 30 April 1996 Directive 96/12/EC 31 March 1997 Directive 96/46/EC 30 April 1997 Directive 96/68/EC 30 November 1997 Directive 97/57/EC 1 October 1997 Directive 2000/80/EC 1 July 2002 Directive 2001/21/EC 1 July 2002 Directive 2001/28/EC 1 August 2001 Directive 2001/36/EC 1 May 2002 Directive 2001/47/EC 31 December 2001 Directive 2001/49/EC 31 December 2001 Directive 2001/87/EC 31 March 2002 Directive 2001/99/EC 1 January 2003 Directive 2001/103/EC 1 April 2003 Directive 2002/18/EC 30 June 2003 Directive 2002/37/EC 31 August 2003 Directive 2002/48/EC 31 December 2002 Directive 2002/64/EC 31 March 2003 Directive 2002/81/EC 30 June 2003 Directive 2003/5/EC 30 April 2004 Directive 2003/23/EC 31 December 2003 Directive 2003/31/EC 30 June 2004 Directive 2003/39/EC 30 September 2004 Directive 2003/68/EC 31 March 2004 Directive 2003/70/EC 30 November 2004 Directive 2003/79/EC 30 June 2004 Directive 2003/81/EC 31 January 2005 Directive 2003/82/EC 30 July 2004 Directive 2003/84/EC 30 June 2004 Directive 2003/112/EC 30 April 2005 Directive 2003/119/EC 30 September 2004 Regulation (EC) No 806/2003 \u2014 Directive 2004/20/EC 31 July 2005 Directive 2004/30/EC 30 November 2004 Directive 2004/58/EC 31 August 2005 Directive 2004/60/EC 28 February 2005 Directive 2004/62/EC 31 March 2005 Directive 2004/66/EC 1 May 2004 Directive 2004/71/EC 31 March 2005 Directive 2004/99/EC 30 June 2005 Directive 2005/2/EC 30 September 2005 Directive 2005/3/EC 30 September 2005 Directive 2005/25/EC 28 May 2006 Directive 2005/34/EC 30 November 2005 Directive 2005/53/EC 31 August 2006 Directive 2005/54/EC 31 August 2006 Directive 2005/57/EC 31 October 2006 Directive 2005/58/EC 31 May 2006 Directive 2005/72/EC 31 December 2006 Directive 2006/5/EC 31 March 2007 Directive 2006/6/EC 31 March 2007 Directive 2006/10/EC 30 September 2006 Directive 2006/16/EC 31 January 2007 Directive 2006/19/EC 30 September 2006 Directive 2006/39/EC 31 July 2007 Directive 2006/41/EC 31 January 2007 Directive 2006/45/EC 18 September 2006 Directive 2006/64/EC 31 October 2007 Directive 2006/74/EC 30 November 2007 Directive 2006/75/EC 31 March 2007 Directive 2006/85/EC 31 January 2008 Directive 2006/104/EC 1 January 2007 Directive 2006/131/EC 30 June 2007 Directive 2006/132/EC 30 June 2007 Directive 2006/133/EC 30 June 2007 Directive 2006/134/EC 30 June 2007 Directive 2006/135/EC 30 June 2007 Directive 2006/136/EC 30 June 2007 Directive 2007/5/EC 31 March 2008 Directive 2007/6/EC 31 July 2007 Directive 2007/21/EC 12 December 2007 Directive 2007/25/EC 31 March 2008 Directive 2007/31/EC 1 September 2007 Directive 2007/50/EC 31 May 2008 Directive 2007/52/EC 31 March 2008 Directive 2007/76/EC 30 April 2009 Directive 2008/40/EC 30 April 2009 Directive 2008/41/EC 30 June 2009 Directive 2008/45/EC 8 August 2008 Directive 2008/66/EC 30 June 2009 B. Directive 79/117/EEC Acts amending Directive 79/117/EEC Deadline for transposition Directive 83/131/EEC 1 October 1984 Directive 85/298/EEC 1 January 1986 Directive 86/214/EEC \u2014 Directive 86/355/EEC 1 July 1987 Directive 87/181/EEC 1 January 1988 and 1 January 1989 Directive 87/477/EEC 1 January 1988 Directive 89/365/EEC 31 December 1989 Directive 90/335/EEC 1 January 1991 Directive 90/533/EEC 31 December 1990 and 30 September 1990 Directive 91/188/EEC 31 March 1992 Regulation (EC) No 807/2003 \u2014 Regulation (EC) No 850/2004 \u2014", "summary": "Pesticide safety on the EU market Pesticide safety on the EU market SUMMARY OF: Regulation (EC) No 1107/2009 \u2013 the placing of plant protection products on the EU market SUMMARY The EU attaches great importance to protecting human and animal health and the environment. Standardising rules on the sale of plant protection products helps to achieve this, ensures the smooth working of the single market and improves agricultural production. WHAT DOES THE REGULATION DO? It lays down rules for authorising the sale, use and control of plant protection products in the EU. It recognises the precautionary principle which EU countries may apply if there is scientific uncertainty about the risks a plant protection product might pose to human or animal health or the environment. KEY POINTS \u2014 The legislation applies to products used to protect or preserve plants, influence their growth or destroy and stunt undesired plants. \u2014 To secure approval, an active substance (any chemical, plant extract or micro-organism that acts against pests or on plants) must not have any harmful effects on human health, including vulnerable groups, or any unacceptable effect on the environment. \u2014 Plant protection products must be effective, have no immediate or delayed harmful effect on human health, no unacceptable effects on plants or the environment and not cause unnecessary suffering or pain to vertebrates. \u2014 The competent national authority in each EU country may attach criteria and restrictions such as minimum degree of purity, type of preparation and manner and conditions of use, when approving a pesticide*. \u2014 The authority gives its first approval for a period not exceeding 10 years. Approval of a renewal request may be for no more than 15 years. \u2014 Applications for approval of an active substance, accompanied by the necessary scientific information, must be submitted to national authorities. They have a maximum of 12 months to examine the request. \u2014 Holders of an authorisation in one EU country may use the mutual recognition procedure to request its use in another. KEY TERM *Pesticide: something that prevents, destroys or controls a harmful organism (pest) or disease, or protects plants or plant products during production, storage and transport. Pesticide is a broader term than plant protection product since it covers non-plant/crop uses like biocides. BACKGROUND For more information: \u2014 Pesticides on the European Commission's website ACT Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 of 24.11.2009, pp. 1\u201350) The successive amendments to Regulation (EC) No 1107/2009 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED ACTS Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Official Journal L 93 of 3.4.2013, pp. 1\u201384). See consolidated version. Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Official Journal L 93 of 3.4.2013, pp. 85\u2013152). See consolidated version. last update 26.11.2015"}
{"article": "14.11.2012 EN Official Journal of the European Union L 316/1 REGULATION (EU) No 1024/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC (\u2018the IMI Regulation\u2019) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The application of certain Union acts governing the free movement of goods, persons, services and capital in the internal market requires Member States to cooperate more effectively and exchange information with one another and with the Commission. As practical means to implement such information exchange are often not specified in those acts, appropriate practical arrangements need to be made. (2) The Internal Market Information System (\u2018IMI\u2019) is a software application accessible via the internet, developed by the Commission in cooperation with the Member States, in order to assist Member States with the practical implementation of information exchange requirements laid down in Union acts by providing a centralised communication mechanism to facilitate cross-border exchange of information and mutual assistance. In particular, IMI helps competent authorities to identify their counterpart in another Member State, to manage the exchange of information, including personal data, on the basis of simple and unified procedures and to overcome language barriers on the basis of pre-defined and pre-translated workflows. Where available, the Commission should provide IMI users with any existing additional translation functionality that meets their needs, is compatible with the security and confidentiality requirements for the exchange of information in IMI and can be offered at a reasonable cost. (3) In order to overcome language barriers, IMI should in principle be available in all official Union languages. (4) The purpose of IMI should be to improve the functioning of the internal market by providing an effective, user-friendly tool for the implementation of administrative cooperation between Member States and between Member States and the Commission, thus facilitating the application of Union acts listed in the Annex to this Regulation. (5) The Commission Communication of 21 February 2011 entitled \u2018Better governance of the Single Market through greater administrative cooperation: A strategy for expanding and developing the Internal Market Information System (\u201cIMI\u201d)\u2019 sets out plans for the possible expansion of IMI to other Union acts. The Commission Communication of 13 April 2011 entitled \u2018Single Market Act: Twelve Levers to boost growth and strengthen confidence \u2014 \u201cWorking together to create new growth\u201d\u2019 stresses the importance of IMI for strengthening cooperation among the actors involved, including at local level, thus contributing to better governance of the single market. It is therefore necessary to establish a sound legal framework for IMI and a set of common rules to ensure that IMI functions efficiently. (6) Where the application of a provision of a Union act requires Member States to exchange personal data and provides for the purpose of this processing, such a provision should be considered an adequate legal basis for the processing of personal data, subject to the conditions set out in Articles 8 and 52 of the Charter of Fundamental Rights of the European Union. IMI should be seen primarily as a tool used for the exchange of information, including personal data, which would otherwise take place via other means, including regular mail, fax or electronic mail on the basis of a legal obligation imposed on Member States\u2019 authorities and bodies in Union acts. Personal data exchanged via IMI should only be collected, processed and used for purposes in line with those for which it was originally collected and should be subject to all relevant safeguards. (7) Following the privacy-by-design principle, IMI has been developed with the requirements of data protection legislation in mind and has been data protection-friendly from its inception, in particular because of the restrictions imposed on access to personal data exchanged in IMI. Therefore, IMI offers a considerably higher level of protection and security than other methods of information exchange such as regular mail, telephone, fax or electronic mail. (8) Administrative cooperation by electronic means between Member States and between Member States and the Commission should comply with the rules on the protection of personal data laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (3) and in Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (4). The definitions used in Directive 95/46/EC and Regulation (EC) No 45/2001 should also apply for the purposes of this Regulation. (9) The Commission supplies and manages the software and IT infrastructure for IMI, ensures the security of IMI, manages the network of national IMI coordinators and is involved in the training of and technical assistance to the IMI users. To that end, the Commission should only have access to such personal data that are strictly necessary to carry out its tasks within the responsibilities set out in this Regulation, such as the registration of national IMI coordinators. The Commission should also have access to personal data when retrieving, upon a request by another IMI actor, such data that have been blocked in IMI and to which the data subject has requested access. The Commission should not have access to personal data exchanged as part of administrative cooperation within IMI, unless a Union act provides for a role for the Commission in such cooperation. (10) In order to ensure transparency, in particular for data subjects, the provisions of Union acts for which IMI is to be used should be listed in the Annex to this Regulation. (11) IMI may be expanded in the future to new areas, where it can help to ensure effective implementation of a Union act in a cost-efficient, user-friendly way, taking account of technical feasibility and overall impact on IMI. The Commission should conduct the necessary tests to verify the technical readiness of IMI for any envisaged expansion. Decisions to expand IMI to further Union acts should be taken by means of the ordinary legislative procedure. (12) Pilot projects are a useful tool for testing whether the expansion of IMI is justified and for adapting technical functionality and procedural arrangements to the requirements of IMI users before a decision on the expansion of IMI is taken. Member States should be fully involved in deciding which Union acts should be subject to a pilot project and on the modalities of that pilot project, in order to ensure that the pilot project reflects the needs of IMI users and that the provisions on processing of personal data are fully complied with. Such modalities should be defined separately for each pilot project. (13) Nothing in this Regulation should preclude Member States and the Commission from deciding to use IMI for the exchange of information which does not involve the processing of personal data. (14) This Regulation should set out the rules for using IMI for the purposes of administrative cooperation, which may cover, inter alia, the one-to-one exchange of information, notification procedures, alert mechanisms, mutual assistance arrangements and problem-solving. (15) The right of the Member States to decide which national authorities carry out the obligations resulting from this Regulation should remain unaffected by this Regulation. Member States should be able to adapt functions and responsibilities in relation to IMI to their internal administrative structures, as well as to implement the needs of a specific IMI workflow. Member States should be able to appoint additional IMI coordinators to carry out the tasks of national IMI coordinators, alone or jointly with others, for a particular area of the internal market, a division of the administration, a geographic region, or according to another criterion. Member States should inform the Commission of the IMI coordinators they have appointed, but they should not be obliged to indicate additional IMI coordinators in IMI, where this is not required for its proper functioning. (16) In order to achieve efficient administrative cooperation through IMI, Member States and the Commission should ensure that their IMI actors have the necessary resources to carry out their obligations in accordance with this Regulation. (17) While IMI is in essence a communication tool for administrative cooperation between competent authorities, which is not open to the general public, technical means may need to be developed to allow external actors such as citizens, enterprises and organisations to interact with the competent authorities in order to supply information or retrieve data, or to exercise their rights as data subjects. Such technical means should include appropriate safeguards for data protection. In order to ensure a high level of security, any such public interface should be developed in such a way as to be technically fully separate from IMI, to which only IMI users should have access. (18) The use of IMI for the technical support of the SOLVIT network should be without prejudice to the informal character of the SOLVIT procedure which is based on a voluntary commitment of the Member States, in accordance with the Commission Recommendation of 7 December 2001 on principles for using \u2018SOLVIT\u2019 \u2014 the Internal Market Problem Solving Network (5) (\u2018the SOLVIT Recommendation\u2019). To continue the functioning of the SOLVIT network on the basis of existing work arrangements, one or more tasks of the national IMI coordinator may be assigned to SOLVIT centres within the remit of their work, so that they can function independently from the national IMI coordinator. The processing of personal data and of confidential information as part of SOLVIT procedures should benefit from all guarantees set out in this Regulation, without prejudice to the non-binding character of the SOLVIT Recommendation. (19) While IMI includes an internet-based interface for its users, in certain cases and at the request of the Member State concerned, it may be appropriate to consider technical solutions for the direct transfer of data from national systems to IMI, where such national systems have already been developed, notably for notification procedures. The implementation of such technical solutions should depend on the outcome of an assessment of their feasibility, costs and expected benefits. Those solutions should not affect the existing structures and the national order of competencies. (20) Where Member States have fulfilled the obligation to notify under Article 15(7) of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (6) by using the procedure in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (7), they should not also be required to make the same notification through IMI. (21) The exchange of information through IMI follows from the legal obligation on Member States\u2019 authorities to give mutual assistance. To ensure that the internal market functions properly, information received by a competent authority through IMI from another Member State should not be deprived of its value as evidence in administrative proceedings solely on the ground that it originated in another Member State or was received by electronic means, and it should be treated by that competent authority in the same way as similar documents originating in its Member State. (22) In order to guarantee a high level of data protection, maximum retention periods for personal data in IMI need to be established. However, those periods should be well-balanced taking into due consideration the need for IMI to function properly, as well as the rights of the data subjects to fully exercise their rights, for instance by obtaining evidence that an information exchange took place in order to appeal against a decision. In particular, retention periods should not go beyond what is necessary to achieve the objectives of this Regulation. (23) It should be possible to process the name and contact details of IMI users for purposes compatible with the objectives of this Regulation, including monitoring of the use of the system by IMI coordinators and the Commission, communication, training and awareness-raising initiatives, and gathering information on administrative cooperation or mutual assistance in the internal market. (24) The European Data Protection Supervisor should monitor and seek to ensure the application of this Regulation, inter alia by maintaining contacts with national data protection authorities, including the relevant provisions on data security. (25) In order to ensure the effective monitoring of, and reporting on, the functioning of IMI and the application of this Regulation, Member States should make relevant information available to the Commission. (26) Data subjects should be informed about the processing of their personal data in IMI and of the fact that they have the right of access to the data relating to them and the right to have inaccurate data corrected and illegally processed data erased, in accordance with this Regulation and national legislation implementing Directive 95/46/EC. (27) In order to make it possible for the competent authorities of the Member States to implement legal provisions for administrative cooperation and efficiently exchange information by means of IMI, it may be necessary to lay down practical arrangements for such an exchange. Those arrangements should be adopted by the Commission in the form of a separate implementing act for each Union act listed in the Annex or for each type of administrative cooperation procedure and should cover the essential technical functionality and procedural arrangements required to implement the relevant administrative cooperation procedures via IMI. The Commission should ensure the maintenance and development of the software and IT infrastructure for IMI. (28) In order to ensure sufficient transparency for data subjects, the predefined workflows, question and answer sets, forms and other arrangements relating to administrative cooperation procedures in IMI should be made public. (29) Where Member States apply, in accordance with Article 13 of Directive 95/46/EC, any limitations on or exceptions to the rights of data subjects, information about such limitations or exceptions should be made public in order to ensure full transparency for data subjects. Such exceptions or limitations should be necessary and proportionate to the intended purpose and subject to adequate safeguards. (30) Where international agreements are concluded between the Union and third countries that also cover the application of provisions of Union acts listed in the Annex to this Regulation, it should be possible to include the counterparts of IMI actors in such third countries in the administrative cooperation procedures supported by IMI, provided that it has been established that the third country concerned offers an adequate level of protection of personal data in accordance with Directive 95/46/EC. (31) Commission Decision 2008/49/EC of 12 December 2007 concerning the implementation of the Internal Market Information System (IMI) as regards the protection of personal data (8) should be repealed. Commission Decision 2009/739/EC of 2 October 2009 setting out the practical arrangements for the exchange of information by electronic means between the Member States under Chapter VI of Directive 2006/123/EC of the European Parliament and of the Council on services in the internal market (9) should continue to apply to issues relating to the exchange of information under Directive 2006/123/EC. (32) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (10). (33) The performance of the Member States regarding the effective application of this Regulation should be monitored in the annual report on the functioning of IMI based on statistical data from IMI and any other relevant data. The performance of Member States should be evaluated, inter alia, based on average reply times with the aim of ensuring rapid replies of good quality. (34) Since the objective of this Regulation, namely laying down the rules for the use of IMI for administrative cooperation, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (35) The European Data Protection Supervisor has been consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 22 November 2011 (11), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down rules for the use of an Internal Market Information System (\u2018IMI\u2019) for administrative cooperation, including processing of personal data, between competent authorities of the Member States and between competent authorities of the Member States and the Commission. Article 2 Establishment of IMI IMI is hereby formally established. Article 3 Scope 1. IMI shall be used for administrative cooperation between competent authorities of the Member States and between competent authorities of the Member States and the Commission necessary for the implementation of Union acts in the field of the internal market, within the meaning of Article 26(2) of the Treaty on the Functioning of the European Union (TFEU), which provide for administrative cooperation, including the exchange of personal data, between Member States or between Member States and the Commission. Those Union acts are listed in the Annex. 2. Nothing in this Regulation shall have the effect of rendering mandatory the provisions of Union acts which have no binding force. Article 4 Expansion of IMI 1. The Commission may carry out pilot projects in order to assess whether IMI would be an effective tool to implement provisions for administrative cooperation of Union acts not listed in the Annex. The Commission shall adopt an implementing act to determine which provisions of Union acts shall be subject to a pilot project and to set out the modalities of each project, in particular the basic technical functionality and procedural arrangements required to implement the relevant administrative cooperation provisions. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24(3). 2. The Commission shall submit an evaluation of the outcome of the pilot project, including data protection issues and effective translation functionalities, to the European Parliament and the Council. Where appropriate, that evaluation may be accompanied by a legislative proposal to amend the Annex to expand the use of IMI to the relevant provisions of Union acts. Article 5 Definitions For the purposes of this Regulation, the definitions laid down in Directive 95/46/EC and Regulation (EC) No 45/2001 shall apply. In addition, the following definitions shall also apply: (a) \u2018IMI\u2019 means the electronic tool provided by the Commission to facilitate administrative cooperation between competent authorities of the Member States and between competent authorities of the Member States and the Commission; (b) \u2018administrative cooperation\u2019 means the working in collaboration of competent authorities of the Member States or competent authorities of the Member States and the Commission, by exchanging and processing information, including through notifications and alerts, or by providing mutual assistance, including for the resolution of problems, for the purpose of better application of Union law; (c) \u2018internal market area\u2019 means a legislative or functional field of the internal market, within the meaning of Article 26(2) TFEU, in which IMI is used in accordance with Article 3 of this Regulation; (d) \u2018administrative cooperation procedure\u2019 means a pre-defined workflow provided for in IMI allowing IMI actors to communicate and interact with each other in a structured manner; (e) \u2018IMI coordinator\u2019 means a body appointed by a Member State to perform support tasks necessary for the efficient functioning of IMI in accordance with this Regulation; (f) \u2018competent authority\u2019 means any body established at either national, regional or local level and registered in IMI with specific responsibilities relating to the application of national law or Union acts listed in the Annex in one or more internal market areas; (g) \u2018IMI actors\u2019 means the competent authorities, IMI coordinators and the Commission; (h) \u2018IMI user\u2019 means a natural person working under the authority of an IMI actor and registered in IMI on behalf of that IMI actor; (i) \u2018external actors\u2019 means natural or legal persons other than IMI users that may interact with IMI only through separate technical means and in accordance with a specific pre-defined workflow provided for that purpose; (j) \u2018blocking\u2019 means applying technical means by which personal data become inaccessible to IMI users via the normal interface of IMI; (k) \u2018formal closure\u2019 means applying the technical facility provided by IMI to close an administrative cooperation procedure. CHAPTER II FUNCTIONS AND RESPONSIBILITIES IN RELATION TO IMI Article 6 IMI coordinators 1. Each Member State shall appoint one national IMI coordinator whose responsibilities shall include: (a) registering or validating registration of IMI coordinators and competent authorities; (b) acting as the main contact point for IMI actors of the Member States for issues relating to IMI, including providing information on aspects relating to the protection of personal data in accordance with this Regulation; (c) acting as interlocutor of the Commission for issues relating to IMI including providing information on aspects relating to the protection of personal data in accordance with this Regulation; (d) providing knowledge, training and support, including basic technical assistance, to IMI actors of the Member States; (e) ensuring the efficient functioning of IMI as far as it is within their control, including the provision of timely and adequate responses by IMI actors of the Member States to requests for administrative cooperation. 2. Each Member State may, in addition, appoint one or more IMI coordinators in order to carry out any of the tasks listed in paragraph 1, in accordance with its internal administrative structure. 3. Member States shall inform the Commission of the IMI coordinators appointed in accordance with paragraphs 1 and 2 and of the tasks for which they are responsible. The Commission shall share that information with the other Member States. 4. All IMI coordinators may act as competent authorities. In such cases an IMI coordinator shall have the same access rights as a competent authority. Each IMI coordinator shall be a controller with respect to its own data processing activities as an IMI actor. Article 7 Competent authorities 1. When cooperating by means of IMI, competent authorities, acting through IMI users in accordance with administrative cooperation procedures, shall ensure that, in accordance with the applicable Union act, an adequate response is provided within the shortest possible period of time, and in any event within the deadline set by that act. 2. A competent authority may invoke as evidence any information, document, finding, statement or certified true copy which it has received electronically by means of IMI, on the same basis as similar information obtained in its own country, for purposes compatible with the purposes for which the data were originally collected. 3. Each competent authority shall be a controller with respect to its own data processing activities performed by an IMI user under its authority and shall ensure that data subjects can exercise their rights in accordance with Chapters III and IV, where necessary, in cooperation with the Commission. Article 8 Commission 1. The Commission shall be responsible for carrying out the following tasks: (a) ensuring the security, availability, maintenance and development of the software and IT infrastructure for IMI; (b) providing a multilingual system, including existing translation functionalities, training in cooperation with the Member States, and a helpdesk to assist Member States in the use of IMI; (c) registering the national IMI coordinators and granting them access to IMI; (d) performing processing operations on personal data in IMI, where provided for in this Regulation, in accordance with the purposes determined by the applicable Union acts listed in the Annex; (e) monitoring the application of this Regulation and reporting back to the European Parliament, the Council and the European Data Protection Supervisor in accordance with Article 25. 2. For the purposes of performing the tasks listed in paragraph 1 and producing statistical reports, the Commission shall have access to the necessary information relating to the processing operations performed in IMI. 3. The Commission shall not participate in administrative cooperation procedures involving the processing of personal data except where required by a provision of a Union act listed in the Annex. Article 9 Access rights of IMI actors and users 1. Only IMI users shall have access to IMI. 2. Member States shall designate the IMI coordinators and competent authorities and the internal market areas in which they have competence. The Commission may play a consultative role in that process. 3. Each IMI actor shall grant and revoke, as necessary, appropriate access rights to its IMI users in the internal market area for which it is competent. 4. Appropriate means shall be put in place by the Commission and the Member States to ensure that IMI users are allowed to access personal data processed in IMI only on a need-to-know basis and within the internal market area or areas for which they were granted access rights in accordance with paragraph 3. 5. The use of personal data processed in IMI for a specific purpose in a way that is incompatible with that original purpose shall be prohibited, unless explicitly provided for by national law in accordance with Union law. 6. Where an administrative cooperation procedure involves the processing of personal data, only the IMI actors participating in that procedure shall have access to such personal data. Article 10 Confidentiality 1. Each Member State shall apply its rules of professional secrecy or other equivalent duties of confidentiality to its IMI actors and IMI users, in accordance with national or Union legislation. 2. IMI actors shall ensure that requests of other IMI actors for confidential treatment of information exchanged by means of IMI are respected by IMI users working under their authority. Article 11 Administrative cooperation procedures IMI shall be based on administrative cooperation procedures implementing the provisions of the relevant Union acts listed in the Annex. Where appropriate, the Commission may adopt implementing acts for a specific Union act listed in the Annex or for a type of administrative cooperation procedure, setting out the essential technical functionality and the procedural arrangements required to enable the operation of the relevant administrative cooperation procedures, including where applicable the interaction between external actors and IMI as referred to in Article 12. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). Article 12 External actors Technical means may be provided to allow external actors to interact with IMI where such interaction is: (a) provided for by a Union act; (b) provided for in an implementing act referred to in Article 11 in order to facilitate administrative cooperation between competent authorities in Member States for the application of the provisions of Union acts listed in the Annex; or (c) necessary for submitting requests in order to exercise their rights as data subjects in accordance with Article 19. Any such technical means shall be separate from IMI and shall not enable external actors to access IMI. CHAPTER III PROCESSING OF PERSONAL DATA AND SECURITY Article 13 Purpose limitation IMI actors shall exchange and process personal data only for the purposes defined in the relevant provisions of the Union acts listed in the Annex. Data submitted to IMI by data subjects shall only be used for the purposes for which the data were submitted. Article 14 Retention of personal data 1. Personal data processed in IMI shall be blocked in IMI as soon as they are no longer necessary for the purpose for which they were collected, depending on the specificities of each type of administrative cooperation and, as a general rule, no later than six months after the formal closure of the administrative cooperation procedure. However, if a longer period is provided for in an applicable Union act listed in the Annex, personal data processed in IMI may be retained for a maximum of 18 months after the formal closure of an administrative cooperation procedure. 2. Where a repository of information for future reference by IMI actors is required pursuant to a binding Union act listed in the Annex, the personal data included in such a repository may be processed for as long as they are needed for this purpose either with the data subject\u2019s consent or where this is provided for in that Union act. 3. Personal data blocked pursuant to this Article shall, with the exception of their storage, only be processed for purposes of proof of an information exchange by means of IMI with the data subject\u2019s consent, unless processing is requested for overriding reasons in the public interest. 4. The blocked data shall be automatically deleted in IMI three years after the formal closure of the administrative cooperation procedure. 5. At the express request of a competent authority in a specific case and with the data subject\u2019s consent, personal data may be deleted before the expiry of the applicable retention period. 6. The Commission shall ensure by technical means the blocking and deletion of personal data and their retrieval in accordance with paragraph 3. 7. Technical means shall be put in place to encourage IMI actors to formally close administrative cooperation procedures as soon as possible after the exchange of information has been completed and to enable IMI actors to involve IMI coordinators responsible in any procedure which has been inactive without justification for longer than two months. Article 15 Retention of personal data of IMI users 1. By way of derogation from Article 14, paragraphs 2 and 3 of this Article shall apply to the retention of personal data of IMI users. Those personal data shall include the full name and all electronic and other means of contact necessary for the purposes of this Regulation. 2. Personal data relating to IMI users shall be stored in IMI as long as they continue to be users of IMI and may be processed for purposes compatible with the objectives of this Regulation. 3. When a natural person ceases to be an IMI user, the personal data relating to that person shall be blocked by technical means for a period of three years. Those data shall, with the exception of their storage, only be processed for purposes of proof of an information exchange by means of IMI and shall be deleted at the end of the three-year period. Article 16 Processing of special categories of data 1. The processing of special categories of data referred to in Article 8(1) of Directive 95/46/EC and Article 10(1) of Regulation (EC) No 45/2001 by means of IMI shall be allowed only on the basis of a specific ground mentioned in Article 8(2) and (4) of that Directive and Article 10(2) of that Regulation and subject to appropriate safeguards provided for in those Articles to ensure the rights of individuals whose personal data are processed. 2. IMI may be used for the processing of data relating to offences, criminal convictions or security measures referred to in Article 8(5) of Directive 95/46/EC and Article 10(5) of Regulation (EC) No 45/2001, subject to safeguards provided for in those Articles, including information on disciplinary, administrative or criminal sanctions or other information necessary to establish the good repute of an individual or a legal person, where the processing of such data is provided for in a Union act constituting the basis for the processing or with the explicit consent of the data subject, subject to specific safeguards referred to in Article 8(5) of Directive 95/46/EC. Article 17 Security 1. The Commission shall ensure that IMI complies with the rules on data security adopted by the Commission pursuant to Article 22 of Regulation (EC) No 45/2001. 2. The Commission shall put in place the necessary measures to ensure security of personal data processed in IMI, including appropriate data access control and a security plan which shall be kept up-to-date. 3. The Commission shall ensure that, in the event of a security incident, it is possible to verify what personal data have been processed in IMI, when, by whom and for what purpose. 4. IMI actors shall take all procedural and organisational measures necessary to ensure the security of personal data processed by them in IMI in accordance with Article 17 of Directive 95/46/EC. CHAPTER IV RIGHTS OF DATA SUBJECTS AND SUPERVISION Article 18 Information to data subjects and transparency 1. IMI actors shall ensure that data subjects are informed about processing of their personal data in IMI as soon as possible and that they have access to information on their rights and how to exercise them, including the identity and contact details of the controller and of the controller\u2019s representative, if any, in accordance with Article 10 or 11 of Directive 95/46/EC and national legislation which is in accordance with that Directive. 2. The Commission shall make publicly available in a way which is easily accessible: (a) information concerning IMI in accordance with Articles 11 and 12 of Regulation (EC) No 45/2001, in a clear and understandable form; (b) information on the data protection aspects of administrative cooperation procedures in IMI as referred to in Article 11 of this Regulation; (c) information on exceptions to or limitations of the rights of data subjects as referred to in Article 20 of this Regulation; (d) types of administrative cooperation procedures, essential IMI functionalities and categories of data that may be processed in IMI; (e) a comprehensive list of all implementing or delegated acts regarding IMI, adopted pursuant to this Regulation or to another Union act, and a consolidated version of the Annex to this Regulation and its subsequent amendments by other Union acts. Article 19 Right of access, correction and deletion 1. IMI actors shall ensure that data subjects may effectively exercise their right of access to data relating to them in IMI, and the right to have inaccurate or incomplete data corrected and unlawfully processed data deleted, in accordance with national legislation. The correction or deletion of data shall be carried out as soon as possible, and at the latest 30 days after the request by the data subject is received by the IMI actor responsible. 2. Where the accuracy or lawfulness of data blocked pursuant to Article 14(1) is contested by the data subject, this fact shall be recorded, as well as the accurate, corrected information. Article 20 Exceptions and limitations Member States shall inform the Commission where they provide for exceptions to, or limitations of, the rights of data subjects set out in this Chapter in national legislation in accordance with Article 13 of Directive 95/46/EC. Article 21 Supervision 1. The national supervisory authority or authorities designated in each Member State and endowed with the powers referred to in Article 28 of Directive 95/46/EC (the \u2018National Supervisory Authority\u2019) shall independently monitor the lawfulness of the processing of personal data by the IMI actors of their Member State and, in particular, shall ensure that the rights of data subjects set out in this Chapter are protected in accordance with this Regulation. 2. The European Data Protection Supervisor shall monitor and seek to ensure that the personal data processing activities of the Commission, in its role as an IMI actor, are carried out in accordance with this Regulation. The duties and powers referred to in Articles 46 and 47 of Regulation (EC) No 45/2001 shall apply accordingly. 3. The National Supervisory Authorities and the European Data Protection Supervisor, each acting within the scope of their respective competencies, shall ensure coordinated supervision of IMI and its use by IMI actors. 4. The European Data Protection Supervisor may invite the National Supervisory Authorities to meet, where necessary, for the purposes of ensuring coordinated supervision of IMI and its use by IMI actors, as referred to in paragraph 3. The cost of such meetings shall be borne by the European Data Protection Supervisor. Further working methods for this purpose, including rules of procedure, may be developed jointly as necessary. A joint report of activities shall be sent to the European Parliament, the Council and the Commission at least every three years. CHAPTER V GEOGRAPHIC SCOPE OF IMI Article 22 National use of IMI 1. A Member State may use IMI for the purpose of administrative cooperation between competent authorities within its territory, in accordance with national law, only where the following conditions are satisfied: (a) no substantial changes to the existing administrative cooperation procedures are required; (b) a notification of the envisaged use of IMI has been submitted to the National Supervisory Authority where required under national law; and (c) it does not have a negative impact on the efficient functioning of IMI for IMI users. 2. Where a Member State intends to make systematic use of IMI for national purposes, it shall notify its intention to the Commission and seek its prior approval. The Commission shall examine whether the conditions set out in paragraph 1 are met. Where necessary, and in accordance with this Regulation, an agreement setting out, inter alia, the technical, financial and organisational arrangements for national use, including the responsibilities of the IMI actors, shall be concluded between the Member State and the Commission. Article 23 Information exchange with third countries 1. Information, including personal data, may be exchanged in IMI pursuant to this Regulation between IMI actors within the Union and their counterparts in a third country only where the following conditions are satisfied: (a) the information is processed pursuant to a provision of a Union act listed in the Annex and an equivalent provision in the law of the third country; (b) the information is exchanged or made available in accordance with an international agreement providing for: (i) the application of a provision of a Union act listed in the Annex by the third country; (ii) the use of IMI; and (iii) the principles and modalities of that exchange; and (c) the third country in question ensures adequate protection of personal data in accordance with Article 25(2) of Directive 95/46/EC, including adequate safeguards that the data processed in IMI shall only be used for the purpose for which they were initially exchanged, and the Commission has adopted a decision in accordance with Article 25(6) of Directive 95/46/EC. 2. Where the Commission is an IMI actor, Article 9(1) and (7) of Regulation (EC) No 45/2001 shall apply to any exchange of personal data processed in IMI with its counterparts in a third country. 3. The Commission shall publish in the Official Journal of the European Union and keep up-to-date a list of third countries authorised to exchange information, including personal data, in accordance with paragraph 1. CHAPTER VI FINAL PROVISIONS Article 24 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 25 Monitoring and reporting 1. The Commission shall report to the European Parliament and the Council on the functioning of IMI on a yearly basis. 2. By 5 December 2017 and every five years thereafter, the Commission shall report to the European Data Protection Supervisor on aspects relating to the protection of personal data in IMI, including data security. 3. For the purpose of producing the reports referred to in paragraphs 1 and 2, Member States shall provide the Commission with any information relevant to the application of this Regulation, including on the application in practice of the data protection requirements laid down in this Regulation. Article 26 Costs 1. The costs incurred for the development, promotion, operation and maintenance of IMI shall be borne by the general budget of the European Union, without prejudice to arrangements under Article 22(2). 2. Unless otherwise stipulated in a Union act, the costs for the IMI operations at Member State level, including the human resources needed for training, promotion and technical assistance (helpdesk) activities, as well as for the administration of IMI at national level, shall be borne by each Member State. Article 27 Repeal Decision 2008/49/EC is repealed. Article 28 Effective application Member States shall take all necessary measures to ensure effective application of this Regulation by their IMI actors. Article 29 Exceptions 1. Notwithstanding Article 4 of this Regulation, the IMI pilot project launched on 16 May 2011 to test the suitability of IMI for the implementation of Article 4 of Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (12) may continue to operate on the basis of the arrangements that were made prior to the entry into force of this Regulation. 2. Notwithstanding Article 8(3) and points (a) and (b) of the first paragraph of Article 12 of this Regulation, for the implementation of the administrative cooperation provisions of the SOLVIT Recommendation through IMI, the involvement of the Commission in administrative cooperation procedures and the existing facility for external actors may continue on the basis of the arrangements that were made prior to the entry into force of this Regulation. The period as referred to in Article 14(1) of this Regulation shall be 18 months for personal data processed in IMI for the purposes of the SOLVIT Recommendation. 3. Notwithstanding Article 4(1) of this Regulation, the Commission may launch a pilot project to assess whether IMI is an efficient, cost-effective and user-friendly tool to implement Article 3(4), (5) and (6) of Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (13). No later than two years after the launch of that pilot project, the Commission shall submit to the European Parliament and the Council the evaluation referred to in Article 4(2) of this Regulation, which shall also cover the interaction between administrative cooperation within the consumer protection cooperation system established in accordance with Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (the Regulation on consumer protection cooperation) (14) and within IMI. 4. Notwithstanding Article 14(1) of this Regulation, any periods up to a maximum of 18 months decided on the basis of Article 36 of Directive 2006/123/EC with regard to administrative cooperation pursuant to Chapter VI thereof shall continue to apply in that area. Article 30 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 October 2012. For the European Parliament The President M. SCHULZ For the Council The President A. D. MAVROYIANNIS (1) OJ C 43, 15.2.2012, p. 14. (2) Position of the European Parliament of 11 September 2012 (not yet published in the Official Journal) and decision of the Council of 4 October 2012. (3) OJ L 281, 23.11.1995, p. 31. (4) OJ L 8, 12.1.2001, p. 1. (5) OJ L 331, 15.12.2001, p. 79. (6) OJ L 376, 27.12.2006, p. 36. (7) OJ L 204, 21.7.1998, p. 37. (8) OJ L 13, 16.1.2008, p. 18. (9) OJ L 263, 7.10.2009, p. 32. (10) OJ L 55, 28.2.2011, p. 13. (11) OJ C 48, 18.2.2012, p. 2. (12) OJ L 18, 21.1.1997, p. 1. (13) OJ L 178, 17.7.2000, p. 1. (14) OJ L 364, 9.12.2004, p. 1. ANNEX PROVISIONS ON ADMINISTRATIVE COOPERATION IN UNION ACTS THAT ARE IMPLEMENTED BY MEANS OF IMI, REFERRED TO IN ARTICLE 3 1. Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (1): Chapter VI, Article 39(5), as well as Article 15(7), unless a notification, as provided for in that latter Article, is made in accordance with Directive 98/34/EC. 2. Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (2): Article 8, Article 50(1), (2) and (3), and Article 56. 3. Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients\u2019 rights in cross-border healthcare (3): Article 10(4). 4. Regulation (EU) No 1214/2011 of the European Parliament and of the Council of 16 November 2011 on the professional cross-border transport of euro cash by road between euro-area Member States (4): Article 11(2). 5. Commission Recommendation of 7 December 2001 on principles for using \u2018SOLVIT\u2019 \u2014 the Internal Market Problem Solving Network (5): Chapters I and II. (1) OJ L 376, 27.12.2006, p. 36. (2) OJ L 255, 30.9.2005, p. 22. (3) OJ L 88, 4.4.2011, p. 45. (4) OJ L 316, 29.11.2011, p. 1. (5) OJ L 331, 15.12.2001, p. 79.", "summary": "The EU\u2019s Internal Market Information System (IMI) The EU\u2019s Internal Market Information System (IMI) SUMMARY OF: Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System WHAT IS THE AIM OF THE REGULATION? It lays down rules on the use of the Internal Market Information (IMI) system for administrative cooperation between EU countries\u2019 competent authorities in Single Market related policy areas. KEY POINTS The IMI system is a secure Internet application that allows national, regional and local authorities to communicate quickly and easily with their counterparts in the EU, Iceland, Liechtenstein and Norway about EU internal market law (i.e. the laws relating to the single market that exists between the EU countries and in which the free movement of goods, services, capital and persons is assured, and where citizens are free to live, work, study and do business). It helps these authorities to overcome practical difficulties related in particular to differences in administrative culture, the use of different languages and the identification of partners in other EU countries. It is a free public service, developed by the Commission available in all EU languages and running since 2008. Major benefits for the publicBy speeding up procedures and improving the communication between public authorities, IMI reduces costs caused by delays and enables authorities to provide a better service to individuals and businesses. As such, IMI is a tool that indirectly helps individuals and businesses to make the most of the opportunities offered by the EU's internal market. Areas where the IMI is used Two examples of directives for which the IMI is used are Directive 2005/36/EC on the recognition of professional qualifications and Directive 2006/123/EC on services in the internal market. Under professional qualifications, the IMI system can be used by an EU country to check the validity of qualifications for professionals wanting to practise in that country. In addition to professional qualifications and services, the following are examples of other areas covered by the IMI: posting of workers: IMI supports the cooperation under the Posting of Workers and the Enforcement directives allowing EU countries to exchange information in the field of labour mobility,Consumer Protection Cooperation (CPC) Network: IMI supports 11 administrative procedures under the new CPC Regulation, helping consumer protection authorities and other stakeholders to cooperate in an efficient and user-friendly way (see summary),cross-border healthcare,Solvit (to which individuals and businesses can submit complaints about national authorities). Thanks to its flexibility, the system can easily be expanded to new areas. A list of areas in which IMI is used is available online. Main functions IMI offers the following main functions: bilateral information exchanges (one-to-one workflow) secure exchanges of information between two competent authorities; multilateral information exchanges (one-to-many workflows) allowing authorities to send out information to multiple recipients; repositories searchable multilingual databases to share information among IMI actors; SOLVIT case handling workflow to support the resolution of complaints from citizens and businesses concerning the application of EU law by public authorities; a public interface, allowing external actors to interact with IMI. Amendments to Regulation (EU) No 1024/2012 Regulation (EU) No 1024/2012 has been amended to enable IMI to be used in the context of: processing applications for a European professional card (Directive 2013/55/EU amending Directive 2005/36/EC \u2014 see summary); the posting of workers providing services (Directive 2014/67/EU \u2014 see summary); the return of cultural objects unlawfully removed from the territory of an EU country (Directive 2014/60/EU \u2014 see summary); the requirements for presenting certain public documents (Regulation (EU) 2016/1191 \u2014 see summary); EU type-approvals for non-road mobile machinery (Regulation (EU) 2016/1628 \u2014 see summary); the single digital gateway which allows online access to procedures and assistance for individuals and businesses (Regulation (EU) 2018/1724 \u2014 see summary); and the posting of drivers in the road transport sector (Directive (EU) 2020/1057). Regulation (EU) 2020/1055 amends the annex to Regulation (EU) No 1024/2012, adding Regulation (EC) No 1071/2009 on operating rules for road haulage and passenger transport companies (see summary) to the list of EU acts implemented by means of IMI. Implementing acts The Commission has adopted the following implementing acts: Implementing Decision 2014/89/EU on a pilot project concerning train driving licences (implementing Directive 2007/59/EC \u2014 see summary) Implementing Decision (EU) 2018/743 on a pilot project to implement the administrative cooperation rules relating to Regulation (EU) 2016/679 on the protection of personal data \u2014 see summary; Implementing Decision (EU) 2019/1253 on a pilot project to implement the administrative cooperation rules set out in Decision 2001/470/EC setting up a European Judicial Network in civil and commercial matters \u2014 see summary; Implementing Decision (EU) 2019/2212 on a pilot project to implement the administrative cooperation rules set out in Regulation (EU) 2017/2394 \u2014 see summary. FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) No 1024/2012 has applied since 4 December 2012. BACKGROUND For more information, see: Internal Market Information System (European Commission). MAIN DOCUMENTS Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC (\u2018the IMI Regulation\u2019) (OJ L 316, 14.11.2012, pp. 1-11) Successive amendments to Regulation (EU) No 1024/2012 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2020/1055 of the European Parliament and of the Council of 15 July 2020 amending Regulations (EC) No 1071/2009, (EC) No 1072/2009 and (EU) No 1024/2012 with a view to adapting them to developments in the road transport sector (OJ L 249, 31.7.2020, pp. 17-32) Directive (EU) 2020/1057 of the European Parliament and of the Council of 15 July 2020 laying down specific rules with respect to Directive 96/71/EC and Directive 2014/67/EU for posting drivers in the road transport sector and amending Directive 2006/22/EC as regards enforcement requirements and Regulation (EU) No 1024/2012 (OJ L 249, 31.7.2020, pp. 49-65) Commission Implementing Decision (EU) 2019/2212 of 20 December 2019 on a pilot project to implement certain administrative cooperation provisions set out in Regulation (EU) 2017/2394 of the European Parliament and of the Council on cooperation between authorities responsible for the enforcement of consumer protection laws by means of the Internal Market Information System (OJ L 332, 23.12.2019, pp. 159-162) Commission Implementing Decision (EU) 2019/1253 of 22 July 2019 on a pilot project to implement the administrative cooperation provisions set out in Council Decision 2001/470/EC establishing a European Judicial Network in civil and commercial matters by means of the Internal Market Information System (OJ L 195, 23.7.2019, pp. 40-42) Commission Implementing Decision (EU) 2018/743 of 16 May 2018 on a pilot project to implement the administrative cooperation provisions set out in Regulation (EU) 2016/679 of the European Parliament and of the Council by means of the Internal Market Information System (OJ L 123, 18.5.2018, pp. 115-118) Commission Implementing Decision 2014/89/EU of 14 February 2014 on a pilot project to implement the administrative cooperation obligations set out in Directive 2007/59/EC of the European Parliament and of the Council by means of the Internal Market Information System (OJ L 45, 15.2.2014, pp. 36-39) last update 16.10.2020"}
{"article": "30.12.2011 EN Official Journal of the European Union L 347/44 REGULATION (EU) No 1343/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 December 2011 on certain provisions for fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area and amending Council Regulation (EC) No 1967/2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The European Community acceded to the Agreement for the establishment of the General Fisheries Commission for the Mediterranean (GFCM Agreement) pursuant to Council Decision 98/416/EC of 16 June 1998 on the accession of the European Community to the General Fisheries Commission for the Mediterranean (3) (GFCM). (2) The GFCM Agreement provides an appropriate framework for multilateral cooperation to promote the development, conservation, rational management and best utilisation of living marine resources in the Mediterranean and the Black Sea at levels which are considered sustainable and at low risk of collapse. (3) The European Union, as well as Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Romania and Slovenia are contracting parties to the GFCM Agreement. (4) Recommendations adopted by the GFCM are binding on its contracting parties. As the Union is a contracting party to the GFCM Agreement, these recommendations are binding on the Union and should therefore be implemented in Union law unless their content is already covered thereby. (5) At its Annual Sessions in 2005, 2006, 2007 and 2008 the GFCM adopted a number of recommendations and resolutions for certain fisheries in the GFCM Agreement area which have been temporarily implemented in Union law by the annual Regulations on fishing opportunities or, in the case of GFCM Recommendations 2005/1 and 2005/2, by Article 4(3) and Article 24 of Council Regulation (EC) No 1967/2006 (4). (6) For reasons of clarity, simplification and legal certainty, and since the permanent character of recommendations requires also a permanent legal instrument for their implementation in Union law, it is appropriate to implement these recommendations via a single legislative act, where future recommendations can be added by way of amendments to that act. (7) GFCM recommendations apply to the entire GFCM Agreement area, that is the Mediterranean and the Black Sea and connecting waters, as defined in the preamble to the GFCM Agreement, and therefore, for reasons of clarity and legal certainty, they should be implemented in a single separate Regulation rather than through amendments to Regulation (EC) No 1967/2006 which covers only the Mediterranean Sea. (8) Certain provisions contained in Regulation (EC) No 1967/2006 should apply not only to the Mediterranean Sea but to the entire GFCM Agreement area. Those provisions should therefore be deleted from Regulation (EC) No 1967/2006 and included in this Regulation. In addition, certain provisions regarding minimum mesh size that are laid down in that Regulation should be further clarified. (9) The \u2018fisheries restricted areas\u2019 established by GFCM recommendations for spatial management measures are equivalent to the \u2018fishing protected areas\u2019 as used in Regulation (EC) No 1967/2006. (10) At its Annual Session of 23 to 27 March 2009 the GFCM adopted, on the basis of scientific advice by the Scientific Advisory Committee (SAC), contained in the report of its 11th session (FAO report No 890), a recommendation on the establishment of a fisheries restricted area in the Gulf of Lions. It is appropriate to implement this measure by means of a fishing effort management system. (11) In Mediterranean mixed fisheries, the selectivity of some fishing gears cannot be permitted to go beyond a certain level. In addition to the overall control and limitation of fishing effort, it is fundamental to limit fishing effort in areas where adults of important stocks aggregate, in order to ensure a risk of reproduction impairment that is low enough to allow for their sustainable exploitation. It is therefore advisable, in respect of the area examined by the SAC, first to limit the fishing effort to previous levels and then not to allow any increase of that level. (12) The advice upon which management measures are based should itself be based on the scientific use of relevant data on fleet capacity and activity, on the biological status of exploited resources and on the social and economic situation of fisheries. Those data need to be collected and submitted in time to allow the subsidiary bodies of the GFCM to prepare their advice. (13) At its Annual Session in 2008, the GFCM adopted a recommendation on a regional scheme of port state measures to combat Illegal, Unreported and Unregulated (IUU) fishing in the GFCM Area. While Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (5) covers generally the content of that recommendation and has been applied since 1 January 2010, there are nevertheless some parts thereof, such as the frequency, the coverage and the procedure for port inspections, which need to be referred to in this Regulation in order to adapt them to the particularities of the GFCM Agreement area. (14) Implementing powers should be conferred on the Commission in order to ensure uniform conditions for the implementation of the provisions of this Regulation in respect of the format and transmission of: the report on the fishing activities carried out in fisheries restricted areas; applications for carrying over lost days due to bad weather in the closed season for dolphinfish fisheries and the report on such carrying over; the report in the context of collecting data on dolphinfish fisheries; information in respect of the use of minimum mesh size for nets used for trawling activities exploiting demersal stocks in the Black Sea; and data on statistical matrices, as well as in respect of cooperation and exchange of information with the Executive Secretary of the GFCM. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (6). (15) In order to ensure that the Union continues to fulfil its obligations under the GFCM Agreement, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the implementation in Union law of amendments, which have become binding on the Union, to existing GFCM measures which have already been implemented in Union law, as regards the provision to the Executive Secretary of the GFCM of information on minimum mesh size in the Black Sea; the transmission to the Executive Secretary of the GFCM of the list of authorised vessels for the purpose of the GFCM Register; port state measures; cooperation, information and reporting; the table, map and geographic coordinates of the GFCM Geographical Sub-Areas; port state inspection procedures for vessels; and GFCM statistical matrices. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down the rules for the application by the Union of the conservation, management, exploitation, monitoring, marketing and enforcement measures for fishery and aquaculture products established by the General Fisheries Commission for the Mediterranean (GFCM). Article 2 Scope 1. This Regulation applies to all commercial fishing and aquaculture activities conducted by EU fishing vessels and nationals of Member States in the GFCM Agreement area. It shall apply without prejudice to Regulation (EC) No 1967/2006. 2. By way of derogation from paragraph 1, this Regulation shall not apply to fishing operations conducted solely for the purpose of scientific investigations which are carried out with the permission and under the authority of the Member State whose flag the vessel is flying and of which the Commission and the Member States in whose waters the research is carried out have been informed in advance. Member States conducting fishing operations for the purpose of scientific investigations shall inform the Commission, the Member States in whose waters the research is carried out and the Scientific, Technical and Economic Committee for Fisheries of all catches from such fishing operations. Article 3 Definitions For the purposes of this Regulation the following definitions shall, in addition to the definitions laid down in Article 3 of Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (7) and Article 2 of Regulation (EC) No 1967/2006, apply: (a) \u2018GFCM Agreement area\u2019 means the Mediterranean and the Black Sea and connecting waters, as described in the GFCM Agreement; (b) \u2018fishing effort\u2019 means the product resulting from multiplying the capacity of a fishing vessel, expressed either in kW or in GT (gross tonnage), by the activity expressed in number of days at sea; (c) \u2018day at sea\u2019 means any calendar day on which a vessel is absent from port, irrespective of the amount of time in the course of that day that that vessel is present in an area; (d) \u2018EU Fleet Register number\u2019 means the Community Fleet Register number defined in Annex I to Commission Regulation (EC) No 26/2004 of 30 December 2003 on the Community fishing fleet register (8). TITLE II TECHNICAL MEASURES CHAPTER I Fisheries restricted areas Section I Fisheries restricted area in the Gulf of Lions Article 4 Establishment of a fisheries restricted area A fisheries restricted area is established in the eastern Gulf of Lions, bounded by lines joining the following geographic coordinates: \u2014 42\u00b0 40\u2032 N, 4\u00b0 20\u2032 E \u2014 42\u00b0 40\u2032 N, 5\u00b0 00\u2032 E \u2014 43\u00b0 00\u2032 N, 4\u00b0 20\u2032 E \u2014 43\u00b0 00\u2032 N, 5\u00b0 00\u2032 E. Article 5 Fishing effort For demersal stocks, the fishing effort of vessels using towed nets, bottom- and mid-water longlines and bottom-set nets in the fisheries restricted area as referred to in Article 4 shall not exceed the level of fishing effort applied in 2008 by each Member State in that area. Article 6 Fishing track record Member States shall, not later than 16 February 2012, submit to the Commission in electronic format a list of vessels flying their flag that had a track record of fishing during the year 2008 in the area referred to in Article 4 and in GFCM Geographical Sub-Area 7 as defined in Annex I. That list shall contain the name of the vessel, its EU Fleet Register number, the period for which the vessel was authorised to fish in the area referred to in Article 4 and the number of days spent by each vessel in the year 2008 in Geographical Sub-Area 7 and more specifically in the area referred to in Article 4. Article 7 Authorised vessels 1. Vessels authorised to fish in the area referred to in Article 4 shall be issued with a fishing authorisation by their Member State in accordance with Article 7 of Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (9). 2. Fishing vessels which do not have records of fishing within the area referred to in Article 4 prior to 31 December 2008 shall not be authorised to start fishing therein. 3. Member States shall, not later than 16 February 2012, communicate to the Commission the national legislation in force on 31 December 2008 concerning: (a) the maximum number of hours per day a vessel is permitted to engage in fishing activity; (b) the maximum number of days per week a vessel is permitted to stay at sea and be absent from port; and (c) the compulsory times for fishing vessels to exit from, and return to, their registered port. Article 8 Protection of sensitive habitats Member States shall ensure that the area referred to in Article 4 is protected from the impact of any other human activity jeopardising the conservation of the features that characterise that area as an area of spawners\u2019 aggregation. Article 9 Information Before 1 February of each year, Member States shall submit to the Commission in electronic format a report on the fishing activities carried out in the area referred to in Article 4. The Commission may adopt implementing acts as regards detailed rules for the format and transmission of the report on such fishing activities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2). Section II Fisheries restricted areas in order to protect deep-sea sensitive habitats Article 10 Establishment of fisheries restricted areas Fishing with towed dredges and bottom trawl nets shall be prohibited in the following areas: (a) deep-sea fisheries restricted area \u2018Lophelia reef off Capo Santa Maria di Leuca\u2019 bounded by lines joining the following coordinates: \u2014 39\u00b0 27,72\u2032 N, 18\u00b0 10,74\u2032 E \u2014 39\u00b0 27,80\u2032 N, 18\u00b0 26,68\u2032 E \u2014 39\u00b0 11,16\u2032 N, 18\u00b0 32,58\u2032 E \u2014 39\u00b0 11,16\u2032 N, 18\u00b0 04,28\u2032 E; (b) deep-sea fisheries restricted area \u2018The Nile delta area cold hydrocarbon seeps\u2019 bounded by lines joining the following coordinates: \u2014 31\u00b0 30,00\u2032 N, 33\u00b0 10,00\u2032 E \u2014 31\u00b0 30,00\u2032 N, 34\u00b0 00,00\u2032 E \u2014 32\u00b0 00,00\u2032 N, 34\u00b0 00,00\u2032 E \u2014 32\u00b0 00,00\u2032 N, 33\u00b0 10,00\u2032 E; (c) deep-sea fisheries restricted area \u2018The Eratosthenes Seamount\u2019 bounded by lines joining the following coordinates: \u2014 33\u00b0 00,00\u2032 N, 32\u00b0 00,00\u2032 E \u2014 33\u00b0 00,00\u2032 N, 33\u00b0 00,00\u2032 E \u2014 34\u00b0 00,00\u2032 N, 33\u00b0 00,00\u2032 E \u2014 34\u00b0 00,00\u2032 N, 32\u00b0 00,00\u2032 E. Article 11 Protection of sensitive habitats Member States shall ensure that their competent authorities are called upon to protect the deep-sea sensitive habitats in the areas referred to in Article 10 from, in particular, the impact of any other activity jeopardising the conservation of the features that characterise those habitats. CHAPTER II Establishment of a closed season for the dolphinfish fisheries using fish aggregating devices Article 12 Closed season 1. The common dolphinfish (Coryphaena hippurus) fisheries using fish aggregating devices (FADs) shall be prohibited from 1 January to 14 August of each year. 2. By way of derogation from paragraph 1, if a Member State can demonstrate that, due to bad weather, the fishing vessels flying its flag were unable to make use of their normal fishing days, that Member State may carry over days lost by its vessels in FAD fisheries until 31 January of the following year. In that case, before the end of the year Member States shall submit to the Commission an application in respect of the number of days to be carried over. 3. Paragraphs 1 and 2 shall also apply in the management zone referred to in Article 26(1) of Regulation (EC) No 1967/2006. 4. The application referred to in paragraph 2 shall contain the following information: (a) a report containing the details of the cessation of fishing activities in question, including appropriate supporting meteorological information; (b) the name of the vessel and its EU Fleet Register number. 5. The Commission shall decide on applications of the kind referred to in paragraph 2 within 6 weeks from the date of receipt of an application and shall inform the Member State in writing of that decision. 6. The Commission shall inform the Executive Secretary of the GFCM of decisions taken pursuant to paragraph 5. Before 1 November of each year, Member States shall send to the Commission a report on the carrying over of days lost in the previous year as referred to in paragraph 2. 7. The Commission may adopt implementing acts as regards detailed rules for the format and transmission of the applications referred to in paragraph 4 and of the report on such carrying over referred to in paragraph 6. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2). Article 13 Fishing authorisations Fishing vessels authorised to participate in the common dolphinfish fishery shall be granted a fishing authorisation in accordance with Article 7 of Regulation (EC) No 1224/2009 and shall be included in a list containing the name of the vessel and its EU Fleet Register number, which the Member State concerned shall provide to the Commission. Vessels of an overall length of less than 10 metres shall be required to have a fishing authorisation. This requirement shall also apply to the management zone referred to in Article 26(1) of Regulation (EC) No 1967/2006. Article 14 Data collection 1. Without prejudice to Council Regulation (EC) No 199/2008 of 25 February 2008 concerning the establishment of a Community framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the Common Fisheries Policy (10), Member States shall set up an appropriate system of collection and treatment of fisheries catch and fishing effort data. 2. Member States shall report to the Commission by 15 January of each year the number of vessels involved in the fishery, as well as the total landings and transhipments of common dolphinfish carried out in the previous year by the fishing vessels flying their flag in each Geographical Sub-Area of the GFCM Agreement area as set out in Annex I. The Commission may adopt implementing acts as regards detailed rules for the format and transmission of such reports. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2). 3. The Commission shall forward the information received from the Member States to the Executive Secretary of the GFCM. CHAPTER III Fishing gear Article 15 Minimum mesh size in the Black Sea 1. The minimum mesh size for nets used for trawling activities exploiting demersal stocks in the Black Sea shall be 40 mm. Panels of netting smaller than 40 mm mesh size opening shall not be used or kept on board. 2. Before 1 February 2012, the net referred to in paragraph 1 shall be replaced by a square-meshed net of 40 mm at the cod-end or, at the duly justified request of the ship-owner, by a diamond meshed net of 50 mm with an acknowledged size selectivity equivalent to or higher than that of square-meshed nets of 40 mm at the cod-end. 3. Member States whose fishing vessels conduct trawling activities exploiting demersal stocks in the Black Sea shall submit to the Commission, for the first time not later than 16 February 2012 and subsequently every 6 months, the list of fishing vessels that conduct such activities in the Black Sea and that are equipped with a square-meshed net of at least 40 mm at the cod-end or diamond meshed nets of at least 50 mm, as well as the percentage that such vessels represent of the whole national demersal trawl fleet. The Commission may adopt implementing acts as regards detailed rules for the format and transmission of the information referred to in this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2). 4. The Commission shall forward the information referred to in paragraph 3 to the Executive Secretary of the GFCM. Article 16 Use of towed dredges and trawl nets fisheries The use of towed dredges and trawl nets fisheries at depths beyond 1 000 m shall be prohibited. TITLE III CONTROL MEASURES CHAPTER I Register of vessels Article 17 Register of authorised vessels 1. Before 1 December of each year, each Member State shall send to the Commission, through the accustomed data-processing support, an updated list of the vessels of more than 15 metres in overall length flying its flag and registered in its territory that it authorises to fish in the GFCM Agreement area by issuance of a fishing authorisation. 2. The list indicated in paragraph 1 shall include the following information: (a) the vessel\u2019s EU Fleet Register number and its external marking, as defined in Annex I to Regulation (EC) No 26/2004; (b) the period during which fishing and/or transhipment is authorised; (c) the fishing gears used. 3. The Commission shall send the updated list to the Executive Secretary of the GFCM before 1 January of each year so that the vessels concerned can be entered on the GFCM register of vessels of more than 15 metres in overall length authorised to fish in the GFCM Agreement area (GFCM register). 4. Any change to be made to the list referred to in paragraph 1 shall be notified to the Commission for transmission to the Executive Secretary of the GFCM, through the accustomed data-processing support, at least 10 working days before the vessel begins fishing activity in the GFCM Agreement area. 5. EU fishing vessels of more than 15 metres in overall length that are not entered on the list referred to in paragraph 1 shall not fish, retain on board, tranship or land any type of fish or shellfish within the GFCM Agreement area. 6. Member States shall take the necessary measures to ensure that: (a) only vessels flying their flag that are included in the list referred to in paragraph 1 and that hold on board a fishing authorisation issued by them are permitted, under the terms of the authorisation, to carry out fishing activities in the GFCM Agreement area; (b) no fishing authorisation is issued to vessels that have carried out illegal, unregulated and unreported fishing (IUU fishing) in the GFCM Agreement area or elsewhere, unless the new owners provide adequate documentary evidence that the previous owners and operators no longer have any legal, beneficial or financial interest in, or exercise any control over, their vessels, or that their vessels neither take part in nor are associated with IUU fishing; (c) as far as possible, their national legislation prohibits owners and operators of vessels flying their flag that are included in the list referred to in paragraph 1 from taking part in, or being associated with, fishing activities carried out in the GFCM Agreement area by vessels not on the GFCM register; (d) as far as possible, their national legislation requires owners of vessels flying their flag that are included in the list referred to in paragraph 1 to be nationals or legal entities within the flag Member State; (e) their vessels comply with all the relevant GFCM conservation and management measures. 7. Member States shall take the necessary measures to prohibit fishing, retention on board, transhipment and landing of fish and shellfish caught in the GFCM Agreement area carried out by vessels of more than 15 metres in overall length that are not on the GFCM register. 8. Member States shall, without delay, communicate to the Commission any information showing that there are strong reasons for suspecting that vessels of more than 15 metres in overall length that are not on the GFCM register are fishing for or transhipping fish and shellfish in the GFCM Agreement area. CHAPTER II Port state measures Article 18 Scope This Chapter shall apply to third-country fishing vessels. Article 19 Prior notice By way of derogation from Article 6(1) of Regulation (EC) No 1005/2008, the period for prior notification shall be at least 72 hours before the estimated time of arrival at the port. Article 20 Port inspections 1. Notwithstanding Article 9(1) of Regulation (EC) No 1005/2008, Member States shall carry out inspections in their designated ports of at least 15 % of landings and transhipment operations each year. 2. Notwithstanding Article 9(2) of Regulation (EC) No 1005/2008, fishing vessels that enter into a Member State\u2019s port without prior authorisation shall be inspected in all cases. Article 21 Inspection procedure In addition to the requirements provided for in Article 10 of Regulation (EC) No 1005/2008, port inspections shall comply with the requirements set out in Annex II to this Regulation. Article 22 Denial of use of port 1. Member States shall not allow a third-country vessel to use their ports for landing, transhipping or processing fisheries products caught in the GFCM Agreement area and shall deny it access to port services, including, inter alia, refuelling and re-supplying services, if the vessel: (a) does not comply with the requirements of this Regulation; (b) is included in a list of vessels that have engaged in, or have supported, IUU fishing adopted by a regional fisheries management organisation; or (c) does not have a valid authorisation to engage in fishing or fishing-related activities in the GFCM Agreement area. By way of derogation from the first subparagraph, nothing shall prevent Member States from allowing, in situations of force majeure or distress within the meaning of Article 18 of the United Nations Convention on the Law of the Sea (11), a third-country vessel from using their ports for services strictly necessary to remedy such situations. 2. Paragraph 1 shall apply in addition to the provisions on denial of use of port provided for by Article 4(2) and Article 37(5) and (6) of Regulation (EC) No 1005/2008. 3. Where a Member State has denied the use of its ports to a third-country vessel in accordance with paragraph 1 or 2, it shall promptly notify the master of the vessel, the flag State, the Commission and the Executive Secretary of the GFCM of such action. 4. Where the grounds for denial referred to in paragraph 1 or 2 no longer apply, the Member State shall withdraw its denial and notify the addressees referred to in paragraph 3 of that withdrawal. TITLE IV COOPERATION, INFORMATION AND REPORTING Article 23 Cooperation and information 1. The Commission and Member States shall cooperate and exchange information with the Executive Secretary of the GFCM, in particular by: (a) requesting information from, and providing information to, relevant databases; (b) requesting cooperation and cooperating in order to promote the effective implementation of this Regulation. 2. Member States shall ensure that their national fisheries-related information systems allow for the direct electronic exchange of information on port state inspections referred to in Title III between them and the Executive Secretary of the GFCM, taking due account of appropriate confidentiality requirements. 3. Member States shall take measures to share, by electronic means, information among relevant national agencies and to coordinate the activities of such agencies in the implementation of the measures set out in Chapter II of Title III. 4. Member States shall establish a list of contact points for the purpose of this Regulation, which shall be transmitted electronically, without delay, to the Commission and to the Executive Secretary and the contracting parties of the GFCM. 5. The Commission may adopt implementing acts as regards detailed rules for cooperation and the exchange of information. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2). Article 24 Reporting of statistical matrices 1. Member States shall submit before 1 May of each year to the Executive Secretary of the GFCM the data for Tasks 1.1, 1.2, 1.3, 1.4 and 1.5 of the GFCM statistical matrix as set out in Section C of Annex III. 2. For the submission of data referred to in paragraph 1, Member States shall use the GFCM data-entry system or any other appropriate data submission standard and protocol that is set by the Executive Secretary of the GFCM and that is available on the GFCM website. 3. Member States shall inform the Commission of the data submitted on the basis of this Article. The Commission may adopt implementing acts as regards detailed rules for the format and transmission of data referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2). TITLE V FINAL PROVISIONS Article 25 Committee procedure 1. The Commission shall be assisted by the Committee for Fisheries and Aquaculture established by Article 30(1) of Regulation (EC) No 2371/2002. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 26 Delegation of powers As far as is necessary, in order to implement in Union law amendments that become obligatory for the Union to existing GFCM measures that have already been implemented in Union law, the Commission shall be empowered to adopt delegated acts, in accordance with Article 27, in order to amend the provisions of this Regulation in respect of the following: (a) the provision to the Executive Secretary of the GFCM of information under Article 15(4); (b) the transmission of the list of authorised vessels to the Executive Secretary of the GFCM under Article 17; (c) port state measures set out in Articles 18 to 22; (d) cooperation, information and reporting set out in Articles 23 and 24; (e) the table, the map and the geographical coordinates of GFCM Geographical Sub-Areas (GSAs) set out in Annex I; (f) port state inspection procedures for vessels set out in Annex II; and (g) GFCM statistical matrices set out in Annex III. Article 27 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 26 shall be conferred on the Commission for a period of 3 years from 19 January 2012. The Commission shall draw up a report in respect of the delegation of power not later than 6 months before the end of the three-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of powers referred to in Article 26 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 26 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 28 Amendments to Regulation (EC) No 1967/2006 Regulation (EC) No 1967/2006 is hereby amended as follows: (1) in Article 4, paragraph 3 is deleted; (2) in Article 9, paragraph 3 is replaced by the following: \u20183. For towed nets, other than those referred to in paragraph 4, the minimum mesh size shall be at least: (a) a square-meshed net of 40 mm at the cod-end; or (b) at the duly justified request of the ship owner, a diamond-meshed net of 50 mm of an acknowledged size selectivity that is equivalent to or higher than that of nets referred to under point (a). Fishing vessels shall be authorised to use and keep on board only one of the two types of nets. The Commission shall submit a report on the implementation of this paragraph to the European Parliament and the Council by 30 June 2012, on the basis of which, as well as on the basis of the information supplied by Member States before 31 December 2011, it shall propose due amendments where appropriate.\u2019; (3) Article 24 is deleted; (4) in Article 27, paragraphs 1 and 4 are deleted. Article 29 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 13 December 2011. For the European Parliament The President J. BUZEK For the Council The President M. SZPUNAR (1) OJ C 354, 28.12.2010, p. 71. (2) Position of the European Parliament of 8 March 2011 (not yet published in the Official Journal) and position of the Council at first reading of 20 October 2011. Position of the European Parliament of 13 December 2011. (3) OJ L 190, 4.7.1998, p. 34. (4) OJ L 409, 30.12.2006, p. 11; as replaced by corrigendum, OJ L 36, 8.2.2007, p. 6. (5) OJ L 286, 29.10.2008, p. 1. (6) OJ L 55, 28.2.2011, p. 13. (7) OJ L 358, 31.12.2002, p. 59. (8) OJ L 5, 9.1.2004, p. 25. (9) OJ L 343, 22.12.2009, p. 1. (10) OJ L 60, 5.3.2008, p. 1. (11) OJ L 179, 23.6.1998, p. 3. ANNEX I A) Table of GFCM GSAs FAO SUB-AREA FAO STATISTICAL DIVISIONS GSAs WESTERN 1.1 BALEARIC 1 Northern Alboran Sea 2 Alboran Island 3 Southern Alboran Sea 4 Algeria 5 Balearic Island 6 Northern Spain 11.1 Sardinia (west) 1.2 GULF OF LIONS 7 Gulf of Lions 1.3 SARDINIA 8 Corsica Island 9 Ligurian and North Tyrrhenian Sea 10 South Tyrrhenian Sea 11.2 Sardinia (east) 12 Northern Tunisia CENTRAL 2.1 ADRIATIC 17 Northern Adriatic 18 Southern Adriatic Sea (part) 2.2 IONIAN 13 Gulf of Hammamet 14 Gulf of Gabes 15 Malta Island 16 South of Sicily 18 Southern Adriatic Sea (part) 19 Western Ionian Sea 20 Eastern Ionian Sea 21 Southern Ionian Sea EASTERN 3.1 AEGEAN 22 Aegean Sea 23 Crete Island 3.2 LEVANT 24 North Levant 25 Cyprus Island 26 South Levant 27 Levant BLACK SEA 4.1 MARMARA 28 Marmara Sea 4.2 BLACK SEA 29 Black Sea 4.3 AZOV SEA 30 Azov Sea B) Map of GFCM GSAs (GFCM, 2009) C) Geographical coordinates for GFCM GSAs (GFCM, 2009) GSAs LIMITS 1 Coast Line 36\u00b0 N 5\u00b0 36\u2032 W 36\u00b0 N 3\u00b0 20\u2032 W 36\u00b0 05\u2032 N 3\u00b0 20\u2032 W 36\u00b0 05\u2032 N 2\u00b0 40\u2032 W 36\u00b0 N 2\u00b0 40\u2032 W 36\u00b0 N 1\u00b0 30\u2032 W 36\u00b0 30\u2032 N 1\u00b0 30\u2032 W 36\u00b0 30\u2032 N 1\u00b0 W 37\u00b0 36\u2032 N 1\u00b0 W 2 36\u00b0 05\u2032 N 3\u00b0 20\u2032 W 36\u00b0 05\u2032 N 2\u00b0 40\u2032 W 35\u00b0 45\u2032 N 3\u00b0 20\u2032 W 35\u00b0 45\u2032 N 2\u00b0 40\u2032 W 3 Coast Line 36\u00b0 N 5\u00b0 36\u2032 W 35\u00b0 49\u2032 N 5\u00b0 36\u2032 W 36\u00b0 N 3\u00b0 20\u2032 W 35\u00b0 45\u2032 N 3\u00b0 20\u2032 W 35\u00b0 45\u2032 N 2\u00b0 40\u2032 W 36\u00b0 N 2\u00b0 40\u2032 W 36\u00b0 N 1\u00b0 13\u2032 W Morocco-Algeria border 4 Coast Line 36\u00b0 N 2\u00b0 13\u2032 W 36\u00b0 N 1\u00b0 30\u2032 W 36\u00b0 30\u2032 N 1\u00b0 30\u2032 W 36\u00b0 30\u2032 N 1\u00b0 W 37\u00b0 N 1\u00b0 W 37\u00b0 N 0\u00b0 30\u2032 E 38\u00b0 N 0\u00b0 30\u2032 E 38\u00b0 N 8\u00b0 35\u2032 E Algeria-Tunisia border Morocco-Algeria border 5 38\u00b0 N 0\u00b0 30\u2032 E 39\u00b0 30\u2032 N 0\u00b0 30\u2032 E 39\u00b0 30\u2032 N 1\u00b0 30\u2032 W 40\u00b0 N 1\u00b0 30\u2032 E 40\u00b0 N 2\u00b0 E 40\u00b0 30\u2032 N 2\u00b0 E 40\u00b0 30\u2032 N 6\u00b0 E 38\u00b0 N 6\u00b0 E 6 Coast line 37\u00b0 36\u2032 N 1\u00b0 W 37\u00b0 N 1\u00b0 W 37\u00b0 N 0\u00b0 30\u2032 E 39\u00b0 30\u2032 N 0\u00b0 30\u2032 E 39\u00b0 30\u2032 N 1\u00b0 30\u2032 W 40\u00b0 N 1\u00b0 30\u2032 E 40\u00b0 N 2\u00b0 E 40\u00b0 30\u2032 N 2\u00b0 E 40\u00b0 30\u2032 N 6\u00b0 E 41\u00b0 47\u2032 N 6\u00b0 E 42\u00b0 26\u2032 N 3\u00b0 09\u2032 E 7 Coast line 42\u00b0 26\u2032 N 3\u00b0 09\u2032 E 41\u00b0 20\u2032 N 8\u00b0 E France-Italy border 8 43\u00b0 15\u2032 N 7\u00b0 38\u2032 E 43\u00b0 15\u2032 N 9\u00b0 45\u2032 E 41\u00b0 18\u2032 N 9\u00b0 45\u2032 E 41\u00b0 20\u2032 N 8\u00b0 E 41\u00b0 18\u2032 N 8\u00b0 E 9 Coast line France-Italy border 43\u00b0 15\u2032 N 7\u00b0 38\u2032 E 43\u00b0 15\u2032 N 9\u00b0 45\u2032 E 41\u00b0 18\u2032 N 9\u00b0 45\u2032 E 41\u00b0 18\u2032 N 13\u00b0 E 10 Coast line (including North Sicily) 41\u00b0 18\u2032 N 13\u00b0 E 41\u00b0 18\u2032 N 11\u00b0 E 38\u00b0 N 11\u00b0 E 38\u00b0 N 12\u00b0 30\u2032 E 11 41\u00b0 47\u2032 N 6\u00b0 E 41\u00b0 18\u2032 N 6\u00b0 E 41\u00b0 18\u2032 N 11\u00b0 E 38\u00b0 30\u2032 N 11\u00b0 E 38\u00b0 30\u2032 N 8\u00b0 30\u2032 E 38\u00b0 N 8\u00b0 30\u2032 E 38\u00b0 N 6\u00b0 E 12 Coast line Algeria-Tunisia border 38\u00b0 N 8\u00b0 30\u2032 E 38\u00b0 30\u2032 N 8\u00b0 30\u2032 E 38\u00b0 30\u2032 N 11\u00b0 E 38\u00b0 N 11\u00b0 E 37\u00b0 N 12\u00b0 E 37\u00b0 N 11\u00b0 04\u2032E 13 Coast line 37\u00b0 N 11\u00b0 04\u2032E 37\u00b0 N 12\u00b0 E 35\u00b0 N 13\u00b0 30\u2032 E 35\u00b0 N 11\u00b0 E 14 Coast line 35\u00b0 N 11\u00b0 E 35\u00b0 N 15\u00b0 18\u2032 E Tunisia-Libya border 15 36\u00b0 30\u2032 N 13\u00b0 30\u2032 E 35\u00b0 N 13\u00b0 30\u2032E 35\u00b0 N 15\u00b0 18\u2032 E 36\u00b0 30\u2032 N 15\u00b0 18\u2032 E 16 Coast line 38\u00b0 N 12\u00b0 30\u2032 E 38\u00b0 N 11\u00b0 E 37\u00b0 N 12\u00b0 E 35\u00b0 N 13\u00b0 30\u2032 E 36\u00b0 30\u2032 N 13\u00b0 30\u2032 E 36\u00b0 30\u2032 N 15\u00b0 18\u2032 E 37\u00b0 N 15\u00b0 18\u2032 E 17 Coast line 41\u00b0 55\u2032 N 15\u00b0 08\u2032 E Croatia-Montenegro border 18 Coast lines (both sides) 41\u00b0 55\u2032 N 15\u00b0 08\u2032 E 40\u00b0 04\u2032 N 18\u00b0 29\u2032 E Croatia-Montenegro border Albania-Greece border 19 Coast line (including East Sicily) 40\u00b0 04\u2032 N 18\u00b0 29\u2032 E 37\u00b0 N 15\u00b0 18\u2032 E 35\u00b0 N 15\u00b0 18\u2032 E 35\u00b0 N 19\u00b0 10\u2032 E 39\u00b0 58\u2032 N 19\u00b0 10\u2032 E 20 Coast line Albania-Greece border 39\u00b0 58\u2032 N 19\u00b0 10\u2032 E 35\u00b0 N 19\u00b0 10\u2032 E 35\u00b0 N 23\u00b0 E 36\u00b0 30\u2032 N 23\u00b0 E 21 Coast line Tunisia-Libya border 35\u00b0 N 15\u00b0 18\u2032 E 35\u00b0 N 23\u00b0 E 34\u00b0 N 23\u00b0 E 34\u00b0 N 25\u00b0 09\u2032 E Libya-Egypt border 22 Coast line 36\u00b0 30\u2032 N 23\u00b0 E 36\u00b0 N 23\u00b0 E 36\u00b0 N 26\u00b0 30\u2032 E 34\u00b0 N 26\u00b0 30\u2032 E 34\u00b0 N 29\u00b0 E 36\u00b0 43\u2032 N 29\u00b0 E 23 36\u00b0 N 23\u00b0 E 36\u00b0 N 26\u00b0 30\u2032 E 34\u00b0 N 26\u00b0 30\u2032 E 34\u00b0 N 23\u00b0 E 24 Coast line 36\u00b0 43\u2032 N 29\u00b0 E 34\u00b0 N 29\u00b0 E 34\u00b0 N 32\u00b0 E 35\u00b0 47\u2032 N 32\u00b0 E 35\u00b0 47\u2032 N 35\u00b0 E Turkey-Syria border 25 35\u00b0 47\u2032 N 32\u00b0 E 34\u00b0 N 32\u00b0 E 34\u00b0 N 35\u00b0 E 35\u00b0 47\u2032 N 35\u00b0 E 26 Coast line Libya-Egypt border 34\u00b0 N 25\u00b0 09\u2032 E 34\u00b0 N 34\u00b0 13\u2032 E Egypt-Gaza Strip border 27 Coast line Egypt-Gaza Strip border 34\u00b0 N 34\u00b0 13\u2032 E 34\u00b0 N 35\u00b0 E 35\u00b0 47\u2032 N 35\u00b0 E Turkey-Syria border 28 29 30 ANNEX II Port state inspection procedures for vessels 1. Vessel identification Port inspectors shall: (a) verify that the official documentation on board is valid, if necessary, through appropriate contacts with the flag State or international records of vessels; (b) where necessary, arrange for an official translation of the documentation; (c) verify that the vessel\u2019s name, flag, any external identification number and markings (and International Maritime Organization (IMO) ship identification number when available) and the international radio call sign are correct; (d) as far as possible, examine whether the vessel has changed name and/or flag and, if so, note the previous name(s) and flag(s); (e) note the port of registration, name and address of the owner (and operator and beneficial owner if different from the owner), agent, and master of the vessel, including the unique ID for company and registered owner if available; and (f) note the names and addresses of previous owners, if any, during the past 5 years. 2. Authorisations Port inspectors shall verify that authorisations to fish or transport fish and fishery products are compatible with the information obtained under point 1 and examine the duration of the authorisations and their application to areas, species and fishing gear. 3. Other documentation Port inspectors shall review all relevant documentation, including documents in electronic format. Relevant documentation may include logbooks, in particular the fishing logbook, as well as the crew list, stowage plans and drawings or descriptions of fish holds if available. Such holds or areas may be inspected in order to verify whether their size and composition correspond to these drawings or descriptions and whether the stowage is in accordance with the stowage plans. Where appropriate, this documentation shall also include catch documents or trade documents issued by any regional fisheries management organisation. 4. Fishing gear (a) Port inspectors shall verify that the fishing gear on board is in conformity with the conditions of the authorisations. The gear may also be checked to ensure that features such as, inter alia, the mesh sizes (and possible devices), length of nets and hook sizes conform with applicable regulations and that identification marks of the gear correspond to those authorised for the vessel. (b) Port inspectors may also search the vessel for any fishing gear stowed out of sight and for fishing gear that is otherwise illegal. 5. Fish and fishery products (a) Port inspectors shall, to the greatest extent possible, examine whether the fish and fishery products on board were harvested in accordance with the conditions set out in the applicable authorisations. In doing so, port inspectors shall examine the fishing logbook and reports submitted, including those transmitted by a vessel monitoring system (VMS), as appropriate. (b) In order to determine the quantities and species on board, port inspectors may examine the fish in the hold or during the landing. In doing so, port inspectors may open cartons where the fish has been pre-packed and move the fish or cartons to ascertain the integrity of fish holds. (c) If the vessel is unloading, port inspectors may verify the species and quantities landed. Such verification may include product type, live weight (quantities determined from the logbook) and the conversion factor used for calculating processed weight to live weight. Port inspectors may also examine any possible quantities retained on board. (d) Port inspectors may review the quantity and composition of all catch on board, including by sampling. 6. Verification of IUU fishing Article 11 of Regulation (EC) No 1005/2008 applies. 7. Report A written report shall be prepared and signed by the inspector on completion of the inspection and a copy provided to the master of the vessel. 8. Results of port state inspections Results of port state inspections shall include at least the following information: (1) Inspection references \u2014 inspecting authority (name of inspecting authority or the alternate body nominated by the authority), \u2014 name of inspector, \u2014 date and time of inspection, \u2014 port of inspection (place where the vessel is inspected), and \u2014 date (date the report is completed). (2) Vessel identification \u2014 name of the vessel, \u2014 type of vessel, \u2014 type of gear, \u2014 external identification number (side number of the vessel) and IMO-number (if available) or other number as appropriate, \u2014 International Radio Call Sign, \u2014 MMS I-number (Maritime Mobile Service Identity number), if available, \u2014 Flag State (the State where the vessel is registered), \u2014 previous names and flags, if any, \u2014 home port (the port of registration of the vessel) and previous home ports, \u2014 vessel owner (name, address, contact), \u2014 vessel beneficial owner if different from the vessel owner (name, address, contact), \u2014 vessel operator responsible for using the vessel if different from the vessel owner (name, address, contact), \u2014 vessel agent (name, address, contact), \u2014 names and addresses of previous owners, if any, \u2014 name, nationality and maritime qualifications of master and fishing master, and \u2014 crew list. (3) Fishing authorisation (licences/permits) \u2014 the vessels\u2019 authorisations to fish or transport fish and fish products, \u2014 states issuing the authorisations, \u2014 terms of the authorisations, including areas and duration, \u2014 relevant regional fisheries management organisation, \u2014 areas, scope and duration of the authorisations, \u2014 details of allocation authorised \u2014 quota, fishing effort or other, \u2014 species, by-catch and fishing gear authorised, and \u2014 transhipment records and documents (where applicable). (4) Fishing trip information \u2014 date, time, zone and place current fishing trip commenced, \u2014 areas visited (entry and exit from different areas), \u2014 transhipment activities at sea (date, species, place, quantity of fish transhipped), \u2014 last port visited, \u2014 date and time when current fishing trip ended, and \u2014 intended next port of call, as appropriate. (5) Result of the inspection on the catch \u2014 start and end of discharge (times and date), \u2014 fish species, \u2014 product type, \u2014 live weight (quantities determined from the logbook), \u2014 relevant conversion factor, \u2014 processed weight (quantities landed by species and presentation), \u2014 equivalent live weight (quantities landed in equivalent live weight, as \u2018product weight multiplied with the conversion factor\u2019), \u2014 intended destination of fish and fishery products inspected, and \u2014 quantity and species of fish retained on board, if any. (6) Results of gear inspection \u2014 details of gear types. (7) Conclusions \u2014 Conclusions of the inspection including identification of the violations believed to have been committed and reference to the relevant rules and measures. Such evidence shall be attached to the inspection report. ANNEX III (A) GFCM/SAC Fleet Segmentation Groups < 6 metres 6-12 metres 12-24 metres More than 24 metres 1. Polyvalent small-scale vessels without engine A 2. Polyvalent small-scale vessels with engine B C 3. Trawlers D E F 4. Purse seiners G H 5. Longliners I 6. Pelagic Trawlers J 7. Tuna seiners K 8. Dredgers L 9. Polyvalent vessels M Description of segments A Polyvalent small-scale vessels without engine\u2014 All vessels less than 12 metres in length (LOA) without an engine (wind or propulsion). B Polyvalent small-scale vessels with engine less than 6 m\u2014 All vessels under 6 metres in length (LOA) with engine. C Polyvalent small-scale vessels with engine between 6 and 12 metres\u2014 All vessels between 6 and 12 metres in length (LOA) with engine, that use different gears during the year without clear predominance of one of them or that use a gear not considered in this classification. D Trawlers less than 12 m\u2014 All vessels less than 12 metres in length (LOA) allocating more than 50 percent of their effort operating with a demersal trawl. E Trawlers between 12 and 24 m\u2014 All vessels, between 12 and 24 metres in length (LOA) allocating more than 50 percent of their effort operating with a demersal trawl. F Trawlers longer than 24 m\u2014 All vessels over 24 metres in length (LOA), allocating more than 50 percent of their effort operating with a demersal trawl. G Purse Seiners between 6 and 12 m\u2014 All vessels between 6 and 12 m in length (LOA), allocating more than 50 percent of their effort operating with a purse seine. H Purse Seiners longer than 12 m\u2014 All vessels over 12 m in length (LOA), allocating more than 50 percent of their effort operating with a purse seine, excluding those using a tuna seine during any time of the year. I Longliners longer than 6 m\u2014 All vessels over 6 m in length (LOA), allocating more than 50 percent of their effort operating with a longline. J Pelagic Trawlers longer than 6 m\u2014 All vessels over 6 m in length (LOA), allocating more than 50 percent of their effort operating with a pelagic trawl. K Tuna seiners\u2014 All vessels operating with a Tuna Seine for any length of time during the year. L Dredgers longer than 6 m\u2014 All vessels over 6 m in length (LOA), allocating more than 50 percent of their effort operating with a dredge. M Polyvalent vessels longer than 12 m\u2014 All vessels over 12 metres in length (LOA), that use different gears during the year without clear predominance of one of them or that use a gear not considered in this classification. Note: All the cells are open for collecting information. The cells left blank in the above table are considered as unlikely to have a significant population. However, if necessary, it is advisable to merge the information of a \u2018blank cell\u2019 with the most appropriate neighbouring \u2018grey cell\u2019. (B) Table on measurement of nominal fishing effort Gear Number and dimension Capacity Activity Nominal Effort (1) Dredge (for molluscs) Open mouth, width of mouth GT Time fishing Dredged bottom surface (2) Trawl (including dredges for flatfishes) Type of trawl (pelagic, bottom) GT and/or GRT Engine power Mesh size Size of the net (width of mouth) Speed GT Time Fishing GT \u00d7 days GT \u00d7 hours kW \u00d7 days Purse seine Length and drop of the net GT Light power Number of small boats GT Length and drop of the net Search time Set GT \u00d7 Fishing sets Length of the net \u00d7 fishing sets Nets Type of net (e.g. trammel net, gillnets, etc.) Net length (used in regulations) GT Net surface Mesh size Net length and drop Time fishing Net length \u00d7 days Surface \u00d7 days Long lines Number of hooks GT Number of longline Characteristics of hooks Bait Number of hooks Number of longline unit Time fishing Number of hooks \u00d7 hours Number of hooks \u00d7 days Number of longline units \u00d7 days/hours Traps GT Number of traps Time fishing Number of traps \u00d7 days Purse seine/FADs Number of FADs Number of FADs Number of trips Number of FADs \u00d7 Number of trips (C) GFCM Task 1 \u2014 Operational Units (1) The effort measures that do not include a time activity should be referred to a period of time (i.e. by year). (2) Should be referred to a particular area (indicating the surface) to estimate fishing intensity (effort/km2) and to relate the effort to exploited communities.", "summary": "Fisheries and aquaculture measures in the General Fisheries Commission for the Mediterranean (GFCM) area Fisheries and aquaculture measures in the General Fisheries Commission for the Mediterranean (GFCM) area SUMMARY OF: Regulation (EU) No 1343/2011 on certain provisions for fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean WHAT IS THE AIM OF THE REGULATION? It lays down rules for conservation, management, exploitation, monitoring, marketing and enforcement measures for fishery and aquaculture products as established by the General Fisheries Commission for the Mediterranean (GFCM) in the Mediterranean Sea, Black Sea and connecting waters. It applies to all commercial fishing and aquaculture activities, as well as to recreational fishing activities where specifically provided for, conducted by EU fishing vessels and nationals. The regulation has been amended by Regulations (EU) 2015/2102 and (EU) 2019/982, generally to extend conservation, management and control measures in response to evolving conditions in the waters concerned. KEY POINTS Fisheries restricted areas Fisheries restricted areas are in place to protect essential fish habitats, vulnerable marine ecosystems and deep-sea sensitive habitats. Fishing with towed dredges and bottom trawl nets are prohibited in the following deep-sea fisheries restricted areas: Lophelia reef off Capo Santa Maria di Leuca; the Nile delta area cold hydrocarbon seeps; the Eratosthenes Seamount. Fishing with bottom trawl nets are prohibited in the following restrictive areas in the Strait of Sicily: East of Adventure Bank; West of Gela Basin; East of Malta Bank. Additional restrictions Jabuka/Pomo Pit area in the Adriatic Sea: seasonal net restrictions, and fishing limited to authorised vessels; restrictions in the Gulf of Lions; spatial or temporal restrictions in the Alboran Sea and the Gulf of Gab\u00e8s; temporal closure and other measures in the Black Sea apply during the spawning season of turbot in the Black Sea; fishing fleet capacity and fishing restrictions for blackspot seabream in the Alboran Sea; dolphinfish fisheries using fish aggregating devices are prohibited from 1 January to 14 August; minimum conservation reference size for Black Sea piked dogfish. Fishing gear restrictions The regulation outlines restrictions on: mesh size and use of trawl nets and gill-nets fisheries in the Black Sea; use of towed dredges and trawl nets fisheries. Conservation and sustainable exploitation of red coral The regulation outlines rules and restrictions including: fishing authorisations; minimum depth for harvesting; minimum basal diameter of colonies; permitted harvesting gear: only hammers to be usedby authorised persons; temporal closures; recording of catches; landing of catches at designated ports only; transhipment operations at sea prohibited. Incidental catches In the case of incidental catches, the following species have to be released unharmed and alive, as far as possible: seabirds; sea turtles; monk seals; cetaceans; protected sharks and rays. Any incidental catch must be recorded in an on-board logbook, with information on the circumstances, including gear type. Management of small pelagic stocks in the Adriatic Sea The reference fishing capacity for small pelagic stocks is established on the basis of the number of vessels officially listed by the EU countries concerned. National authorities must ensure that the overall fleet capacity does not at any time exceed this reference fishing capacity. Register of authorised vessels Before 1 December of each year, each EU country must supply a list of the vessels of more than 15 metres in length flying its flag and registered in its territory that it authorises to fish in the GFCM Agreement area. Fishing authorisations Lists of operating vessels with fishing authorisations must be communicated as regards: blackspot seabream in the Alboran Sea, demersal stocks in the Strait of Sicily, turbot in the Black Sea, red coral, dolphinfish, fishing in the Jabuka/Pomo Pit area. Inspections in the Strait of Sicily The regulation introduces an international joint inspection and surveillance scheme in international waters in the Strait of Sicily and details the procedures to follow for the conduct of inspections and the detection of infringements. Non-EU vessels EU countries can deny non-EU vessels access to port services, including refuelling and resupplying services, if the vessel does not comply with this regulation or is unauthorised. Cooperation and information The European Commission and EU countries must share information with the Executive Secretary of the GFCM, in particular by using relevant databases and requesting cooperation and cooperating to promote the effective implementation of the regulation. FROM WHEN DOES THE REGULATION APPLY? The original regulation (EU) No 1343/2011 has applied since 19 January 2012. Amending rules have applied since 28 November 2015 (Regulation (EU) 2015/2102 concerning the sustainable exploitation of red coral and mitigating incidental catches of seabirds, turtles, monk seals and cetaceans) and 10 July 2019 (Regulation (EU) 2019/982 minimising incidental catches of certain sensitive marine species and negative environmental impacts of fishing on marine habitats). BACKGROUND See also: General Fisheries Commission for the Mediterranean (GFCM) (Food and Agriculture Organization of the United Nations). MAIN DOCUMENT Regulation (EU) No 1343/2011 of the European Parliament and of the Council of 13 December 2011 on certain provisions for fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area and amending Council Regulation (EC) No 1967/2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea (OJ L 347, 30.12.2011, pp. 44-61) Successive amendments to Regulation (EU) No 1343/2011 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2019/982 of the European Parliament and of the Council of 5 June 2019 amending Regulation (EU) No 1343/2011 on certain provisions for fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area (OJ L 164, 20.6.2019, pp. 1-22) Regulation (EU) 2015/2102 of the European Parliament and of the Council of 28 October 2015 amending Regulation (EU) No 1343/2011 on certain provisions for fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area (OJ L 308, 25.11.2015, pp. 1-10) Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, pp. 11-85). Text republished in corrigendum (OJ L 36, 8.2.2007, pp. 6-30) See consolidated version. last update 22.10.2019"}
{"article": "31.12.2012 EN Official Journal of the European Union L 361/1 REGULATION (EU) No 1257/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union and in particular the first paragraph of Article 118 thereof, Having regard to Council Decision 2011/167/EU of 10 March 2011 authorising enhanced cooperation in the area of the creation of unitary patent protection (1), Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The creation of the legal conditions enabling undertakings to adapt their activities in manufacturing and distributing products across national borders and providing them with greater choice and more opportunities contributes to the attainment of the objectives of the Union set out in Article 3(3) of the Treaty on European Union. Uniform patent protection within the internal market, or at least a significant part thereof, should feature amongst the legal instruments which undertakings have at their disposal. (2) Pursuant to the first paragraph of Article 118 of the Treaty on the Functioning of the European Union (TFEU), measures to be taken in the context of the establishment and functioning of the internal market include the creation of uniform patent protection throughout the Union and the establishment of centralised Union-wide authorisation, coordination and supervision arrangements. (3) On 10 March 2011, the Council adopted Decision 2011/167/EU authorising enhanced cooperation between Belgium, Bulgaria, the Czech Republic, Denmark, Germany, Estonia, Ireland, Greece, France, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, the Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Finland, Sweden and the United Kingdom (hereinafter \u2018participating Member States\u2019) in the area of the creation of unitary patent protection. (4) Unitary patent protection will foster scientific and technological advances and the functioning of the internal market by making access to the patent system easier, less costly and legally secure. It will also improve the level of patent protection by making it possible to obtain uniform patent protection in the participating Member States and eliminate costs and complexity for undertakings throughout the Union. It should be available to proprietors of a European patent from both the participating Member States and from other States, regardless of their nationality, residence or place of establishment. (5) The Convention on the Grant of European Patents of 5 October 1973, as revised on 17 December 1991 and on 29 November 2000 (hereinafter \u2018EPC\u2019), established the European Patent Organisation and entrusted it with the task of granting European patents. This task is carried out by the European Patent Office (hereinafter \u2018EPO\u2019). A European patent granted by the EPO should, at the request of the patent proprietor, benefit from unitary effect by virtue of this Regulation in the participating Member States. Such a patent is hereinafter referred to as a \u2018European patent with unitary effect\u2019. (6) In accordance with Part IX of the EPC a group of Contracting States to the EPC may provide that European patents granted for those States have a unitary character. This Regulation constitutes a special agreement within the meaning of Article 142 of the EPC, a regional patent treaty within the meaning of Article 45(1) of the Patent Cooperation Treaty of 19 June 1970 as last modified on 3 February 2001 and a special agreement within the meaning of Article 19 of the Convention for the Protection of Industrial Property, signed in Paris on 20 March 1883 and last amended on 28 September 1979. (7) Unitary patent protection should be achieved by attributing unitary effect to European patents in the post-grant phase by virtue of this Regulation and in respect of all the participating Member States. The main feature of a European patent with unitary effect should be its unitary character, i.e. providing uniform protection and having equal effect in all the participating Member States. Consequently, a European patent with unitary effect should only be limited, transferred or revoked, or lapse, in respect of all the participating Member States. It should be possible for a European patent with unitary effect to be licensed in respect of the whole or part of the territories of the participating Member States. To ensure the uniform substantive scope of protection conferred by unitary patent protection, only European patents that have been granted for all the participating Member States with the same set of claims should benefit from unitary effect. Finally, the unitary effect attributed to a European patent should have an accessory nature and should be deemed not to have arisen to the extent that the basic European patent has been revoked or limited. (8) In accordance with the general principles of patent law and Article 64(1) of the EPC, unitary patent protection should take effect retroactively in the participating Member States as from the date of publication of the mention of the grant of the European patent in the European Patent Bulletin. Where unitary patent protection takes effect, the participating Member States should ensure that the European patent is deemed not to have taken effect on their territory as a national patent, so as to avoid any duplication of patent protection. (9) The European patent with unitary effect should confer on its proprietor the right to prevent any third party from committing acts against which the patent provides protection. This should be ensured through the establishment of a Unified Patent Court. In matters not covered by this Regulation or by Council Regulation (EU) No 1260/2012 of 17 December 2012 implementing enhanced cooperation in the area of unitary patent protection with regard to the applicable translation arrangements (3), the provisions of the EPC, the Agreement on a Unified Patent Court, including its provisions defining the scope of that right and its limitations, and national law, including rules of private international law, should apply. (10) Compulsory licences for European patents with unitary effect should be governed by the laws of the participating Member States as regards their respective territories. (11) In its report on the operation of this Regulation, the Commission should evaluate the functioning of the applicable limitations and, where necessary, make appropriate proposals, taking account of the contribution of the patent system to innovation and technological progress, the legitimate interests of third parties and overriding interests of society. The Agreement on a Unified Patent Court does not preclude the European Union from exercising its powers in this field. (12) In accordance with the case-law of the Court of Justice of the European Union, the principle of the exhaustion of rights should also be applied to European patents with unitary effect. Therefore, rights conferred by a European patent with unitary effect should not extend to acts concerning the product covered by that patent which are carried out within the participating Member States after that product has been placed on the market in the Union by the patent proprietor. (13) The regime applicable to damages should be governed by the laws of the participating Member States, in particular the provisions implementing Article 13 of Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (4). (14) As an object of property, a European patent with unitary effect should be dealt with in its entirety, and in all the participating Member States, as a national patent of the participating Member State determined in accordance with specific criteria such as the applicant\u2019s residence, principal place of business or place of business. (15) In order to promote and facilitate the economic exploitation of an invention protected by a European patent with unitary effect, the proprietor of that patent should be able to offer it to be licensed in return for appropriate consideration. To that end, the patent proprietor should be able to file a statement with the EPO that he is prepared to grant a license in return for appropriate consideration. In that case, the patent proprietor should benefit from a reduction of the renewal fees as from the EPO\u2019s receipt of such statement. (16) The group of Member States making use of the provisions of Part IX of the EPC may give tasks to the EPO and set up a select committee of the Administrative Council of the European Patent Organisation (hereinafter \u2018Select Committee\u2019). (17) The participating Member States should give certain administrative tasks relating to European patents with unitary effect to the EPO, in particular as regards the administration of requests for unitary effect, the registration of unitary effect and of any limitation, licence, transfer, revocation or lapse of European patents with unitary effect, the collection and distribution of renewal fees, the publication of translations for information purposes during a transitional period and the administration of a compensation scheme for the reimbursement of translation costs incurred by applicants filing European patent applications in a language other than one of the official languages of the EPO. (18) In the framework of the Select Committee, the participating Member States should ensure the governance and supervision of the activities related to the tasks entrusted to the EPO by the participating Member States, ensure that requests for unitary effect are filed with the EPO within one month of the date of publication of the mention of the grant in the European Patent Bulletin and ensure that such requests are submitted in the language of the proceedings before the EPO together with the translation prescribed, during a transitional period, by Regulation (EU) No 1260/2012. The participating Member States should also ensure the setting, in accordance with the voting rules laid down in Article 35(2) of the EPC, of the level of the renewal fees and the share of the distribution of the renewal fees in accordance with the criteria set out in this Regulation. (19) Patent proprietors should pay a single annual renewal fee for a European patent with unitary effect. Renewal fees should be progressive throughout the term of the patent protection and, together with the fees to be paid to the European Patent Organisation during the pre-grant stage, should cover all costs associated with the grant of the European patent and the administration of the unitary patent protection. The level of the renewal fees should be set with the aim of facilitating innovation and fostering the competitiveness of European businesses, taking into account the situation of specific entities such as small and medium-sized enterprises, for example in the form of lower fees. It should also reflect the size of the market covered by the patent and be similar to the level of the national renewal fees for an average European patent taking effect in the participating Member States at the time when the level of the renewal fees is first set. (20) The appropriate level and distribution of renewal fees should be determined in order to ensure that, in relation to the unitary patent protection, all costs of the tasks entrusted to the EPO are fully covered by the resources generated by the European patents with unitary effect and that, together with the fees to be paid to the European Patent Organisation during the pre-grant stage, the revenues from the renewal fees ensure a balanced budget of the European Patent Organisation. (21) Renewal fees should be paid to the European Patent Organisation. The EPO should retain an amount to cover the expenses generated at the EPO in carrying out tasks in relation to the unitary patent protection in accordance with Article 146 of the EPC. The remaining amount should be distributed among the participating Member States and should be used for patent-related purposes. The share of distribution should be set on the basis of fair, equitable and relevant criteria, namely the level of patent activity and the size of the market, and should guarantee a minimum amount to be distributed to each participating Member State in order to maintain a balanced and sustainable functioning of the system. The distribution should provide compensation for having an official language other than one of the official languages of the EPO, having a disproportionately low level of patenting activity established on the basis of the European Innovation Scoreboard, and/or having acquired membership of the European Patent Organisation relatively recently. (22) An enhanced partnership between the EPO and central industrial property offices of the Member States should enable the EPO to make regular use, where appropriate, of the result of any search carried out by central industrial property offices on a national patent application the priority of which is claimed in a subsequent European patent application. All central industrial property offices, including those which do not perform searches in the course of a national patent-granting procedure, can play an essential role under the enhanced partnership, inter alia, by giving advice and support to potential patent applicants, in particular small and medium-sized enterprises, by receiving applications, by forwarding applications to the EPO and by disseminating patent information. (23) This Regulation is complemented by Regulation (EU) No 1260/2012, adopted by the Council in accordance with the second paragraph of Article 118 of the TFEU. (24) Jurisdiction in respect of European patents with unitary effect should be established and governed by an instrument setting up a unified patent litigation system for European patents and European patents with unitary effect. (25) Establishing a Unified Patent Court to hear cases concerning the European patent with unitary effect is essential in order to ensure the proper functioning of that patent, consistency of case-law and hence legal certainty, and cost-effectiveness for patent proprietors. It is therefore of paramount importance that the participating Member States ratify the Agreement on a Unified Patent Court in accordance with their national constitutional and parliamentary procedures and take the necessary steps for that Court to become operational as soon as possible. (26) This Regulation should be without prejudice to the right of the participating Member States to grant national patents and should not replace the participating Member States\u2019 laws on patents. Patent applicants should remain free to obtain either a national patent, a European patent with unitary effect, a European patent taking effect in one or more of the Contracting States to the EPC or a European patent with unitary effect validated in addition in one or more other Contracting States to the EPC which are not among the participating Member States. (27) Since the objective of this Regulation, namely the creation of unitary patent protection, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Regulation, be better achieved at Union level, the Union may adopt measures, where appropriate by means of enhanced cooperation, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter 1. This Regulation implements enhanced cooperation in the area of the creation of unitary patent protection, authorised by Decision 2011/167/EU. 2. This Regulation constitutes a special agreement within the meaning of Article 142 of the Convention on the Grant of European Patents of 5 October 1973, as revised on 17 December 1991 and on 29 November 2000 (hereinafter \u2018EPC\u2019). Article 2 Definitions For the purposes of this Regulation, the following definitions shall apply: (a) \u2018Participating Member State\u2019 means a Member State which participates in enhanced cooperation in the area of the creation of unitary patent protection by virtue of Decision 2011/167/EU, or by virtue of a decision adopted in accordance with the second or third subparagraph of Article 331(1) of the TFEU, at the time the request for unitary effect as referred to in Article 9 is made; (b) \u2018European patent\u2019 means a patent granted by the European Patent Office (hereinafter \u2018EPO\u2019) under the rules and procedures laid down in the EPC; (c) \u2018European patent with unitary effect\u2019 means a European patent which benefits from unitary effect in the participating Member States by virtue of this Regulation; (d) \u2018European Patent Register\u2019 means the register kept by the EPO under Article 127 of the EPC; (e) \u2018Register for unitary patent protection\u2019 means the register constituting part of the European Patent Register in which the unitary effect and any limitation, licence, transfer, revocation or lapse of a European patent with unitary effect are registered; (f) \u2018European Patent Bulletin\u2019 means the periodical publication provided for in Article 129 of the EPC. Article 3 European patent with unitary effect 1. A European patent granted with the same set of claims in respect of all the participating Member States shall benefit from unitary effect in the participating Member States provided that its unitary effect has been registered in the Register for unitary patent protection. A European patent granted with different sets of claims for different participating Member States shall not benefit from unitary effect. 2. A European patent with unitary effect shall have a unitary character. It shall provide uniform protection and shall have equal effect in all the participating Member States. It may only be limited, transferred or revoked, or lapse, in respect of all the participating Member States. It may be licensed in respect of the whole or part of the territories of the participating Member States. 3. The unitary effect of a European patent shall be deemed not to have arisen to the extent that the European patent has been revoked or limited. Article 4 Date of effect 1. A European patent with unitary effect shall take effect in the participating Member States on the date of publication by the EPO of the mention of the grant of the European patent in the European Patent Bulletin. 2. The participating Member States shall take the necessary measures to ensure that, where the unitary effect of a European patent has been registered and extends to their territory, that European patent is deemed not to have taken effect as a national patent in their territory on the date of publication of the mention of the grant in the European Patent Bulletin. CHAPTER II EFFECTS OF A EUROPEAN PATENT WITH UNITARY EFFECT Article 5 Uniform protection 1. The European patent with unitary effect shall confer on its proprietor the right to prevent any third party from committing acts against which that patent provides protection throughout the territories of the participating Member States in which it has unitary effect, subject to applicable limitations. 2. The scope of that right and its limitations shall be uniform in all participating Member States in which the patent has unitary effect. 3. The acts against which the patent provides protection referred to in paragraph 1 and the applicable limitations shall be those defined by the law applied to European patents with unitary effect in the participating Member State whose national law is applicable to the European patent with unitary effect as an object of property in accordance with Article 7. 4. In its report referred to in Article 16(1), the Commission shall evaluate the functioning of the applicable limitations and shall, where necessary, make appropriate proposals. Article 6 Exhaustion of the rights conferred by a European patent with unitary effect The rights conferred by a European patent with unitary effect shall not extend to acts concerning a product covered by that patent which are carried out within the participating Member States in which that patent has unitary effect after that product has been placed on the market in the Union by, or with the consent of, the patent proprietor, unless there are legitimate grounds for the patent proprietor to oppose further commercialisation of the product. CHAPTER III A EUROPEAN PATENT WITH UNITARY EFFECT AS AN OBJECT OF PROPERTY Article 7 Treating a European patent with unitary effect as a national patent 1. A European patent with unitary effect as an object of property shall be treated in its entirety and in all the participating Member States as a national patent of the participating Member State in which that patent has unitary effect and in which, according to the European Patent Register: (a) the applicant had his residence or principal place of business on the date of filing of the application for the European patent; or (b) where point (a) does not apply, the applicant had a place of business on the date of filing of the application for the European patent. 2. Where two or more persons are entered in the European Patent Register as joint applicants, point (a) of paragraph 1 shall apply to the joint applicant indicated first. Where this is not possible, point (a) of paragraph 1 shall apply to the next joint applicant indicated in the order of entry. Where point (a) of paragraph 1 does not apply to any of the joint applicants, point (b) of paragraph 1 shall apply accordingly. 3. Where no applicant had his residence, principal place of business or place of business in a participating Member State in which that patent has unitary effect for the purposes of paragraphs 1 or 2, the European patent with unitary effect as an object of property shall be treated in its entirety and in all the participating Member States as a national patent of the State where the European Patent Organisation has its headquarters in accordance with Article 6(1) of the EPC. 4. The acquisition of a right may not be dependent on any entry in a national patent register. Article 8 Licences of right 1. The proprietor of a European patent with unitary effect may file a statement with the EPO to the effect that the proprietor is prepared to allow any person to use the invention as a licensee in return for appropriate consideration. 2. A licence obtained under this Regulation shall be treated as a contractual licence. CHAPTER IV INSTITUTIONAL PROVISIONS Article 9 Administrative tasks in the framework of the European Patent Organisation 1. The participating Member States shall, within the meaning of Article 143 of the EPC, give the EPO the following tasks, to be carried out in accordance with the internal rules of the EPO: (a) to administer requests for unitary effect by proprietors of European patents; (b) to include the Register for unitary patent protection within the European Patent Register and to administer the Register for unitary patent protection; (c) to receive and register statements on licensing referred to in Article 8, their withdrawal and licensing commitments undertaken by the proprietor of the European patent with unitary effect in international standardisation bodies; (d) to publish the translations referred to in Article 6 of Regulation (EU) No 1260/2012 during the transitional period referred to in that Article; (e) to collect and administer renewal fees for European patents with unitary effect, in respect of the years following the year in which the mention of the grant is published in the European Patent Bulletin; to collect and administer additional fees for late payment of renewal fees where such late payment is made within six months of the due date, as well as to distribute part of the collected renewal fees to the participating Member States; (f) to administer the compensation scheme for the reimbursement of translation costs referred to in Article 5 of Regulation (EU) No 1260/2012; (g) to ensure that a request for unitary effect by a proprietor of a European patent is submitted in the language of the proceedings as defined in Article 14(3) of the EPC no later than one month after the mention of the grant is published in the European Patent Bulletin; and (h) to ensure that the unitary effect is indicated in the Register for unitary patent protection, where a request for unitary effect has been filed and, during the transitional period provided for in Article 6 of Regulation (EU) No 1260/2012, has been submitted together with the translations referred to in that Article, and that the EPO is informed of any limitations, licences, transfers or revocations of European patents with unitary effect. 2. The participating Member States shall ensure compliance with this Regulation in fulfilling their international obligations undertaken in the EPC and shall cooperate to that end. In their capacity as Contracting States to the EPC, the participating Member States shall ensure the governance and supervision of the activities related to the tasks referred to in paragraph 1 of this Article and shall ensure the setting of the level of renewal fees in accordance with Article 12 of this Regulation and the setting of the share of distribution of the renewal fees in accordance with Article 13 of this Regulation. To that end they shall set up a select committee of the Administrative Council of the European Patent Organisation (hereinafter \u2018Select Committee\u2019) within the meaning of Article 145 of the EPC. The Select Committee shall consist of the representatives of the participating Member States and a representative of the Commission as an observer, as well as alternates who will represent them in their absence. The members of the Select Committee may be assisted by advisers or experts. Decisions of the Select Committee shall be taken with due regard for the position of the Commission and in accordance with the rules laid down in Article 35(2) of the EPC. 3. The participating Member States shall ensure effective legal protection before a competent court of one or several participating Member States against the decisions of the EPO in carrying out the tasks referred to in paragraph 1. CHAPTER V FINANCIAL PROVISIONS Article 10 Principle on expenses The expenses incurred by the EPO in carrying out the additional tasks given to it, within the meaning of Article 143 of the EPC, by the participating Member States shall be covered by the fees generated by the European patents with unitary effect. Article 11 Renewal fees 1. Renewal fees for European patents with unitary effect and additional fees for their late payment shall be paid to the European Patent Organisation by the patent proprietor. Those fees shall be due in respect of the years following the year in which the mention of the grant of the European patent which benefits from unitary effect is published in the European Patent Bulletin. 2. A European patent with unitary effect shall lapse if a renewal fee and, where applicable, any additional fee have not been paid in due time. 3. Renewal fees which fall due after receipt of the statement referred to in Article 8(1) shall be reduced. Article 12 Level of renewal fees 1. Renewal fees for European patents with unitary effect shall be: (a) progressive throughout the term of the unitary patent protection; (b) sufficient to cover all costs associated with the grant of the European patent and the administration of the unitary patent protection; and (c) sufficient, together with the fees to be paid to the European Patent Organisation during the pre-grant stage, to ensure a balanced budget of the European Patent Organisation. 2. The level of the renewal fees shall be set, taking into account, among others, the situation of specific entities such as small and medium-sized enterprises, with the aim of: (a) facilitating innovation and fostering the competitiveness of European businesses; (b) reflecting the size of the market covered by the patent; and (c) being similar to the level of the national renewal fees for an average European patent taking effect in the participating Member States at the time the level of the renewal fees is first set. 3. In order to attain the objectives set out in this Chapter, the level of renewal fees shall be set at a level that: (a) is equivalent to the level of the renewal fee to be paid for the average geographical coverage of current European patents; (b) reflects the renewal rate of current European patents; and (c) reflects the number of requests for unitary effect. Article 13 Distribution 1. The EPO shall retain 50 per cent of the renewal fees referred to in Article 11 paid for European patents with unitary effect. The remaining amount shall be distributed to the participating Member States in accordance with the share of distribution of the renewal fees set pursuant to Article 9(2). 2. In order to attain the objectives set out in this Chapter, the share of distribution of renewal fees among the participating Member States shall be based on the following fair, equitable and relevant criteria: (a) the number of patent applications; (b) the size of the market, while ensuring a minimum amount to be distributed to each participating Member State; (c) compensation to the participating Member States which have: (i) an official language other than one of the official languages of the EPO; (ii) a disproportionately low level of patenting activity; and/or (iii) acquired membership of the European Patent Organisation relatively recently. CHAPTER VI FINAL PROVISIONS Article 14 Cooperation between the Commission and the EPO The Commission shall establish a close cooperation through a working agreement with the EPO in the fields covered by this Regulation. This cooperation shall include regular exchanges of views on the functioning of the working agreement and, in particular, on the issue of renewal fees and their impact on the budget of the European Patent Organisation. Article 15 Application of competition law and the law relating to unfair competition This Regulation shall be without prejudice to the application of competition law and the law relating to unfair competition. Article 16 Report on the operation of this Regulation 1. Not later than three years from the date on which the first European patent with unitary effect takes effect, and every five years thereafter, the Commission shall present to the European Parliament and the Council a report on the operation of this Regulation and, where necessary, make appropriate proposals for amending it. 2. The Commission shall regularly submit to the European Parliament and the Council reports on the functioning of the renewal fees referred to in Article 11, with particular emphasis on compliance with Article 12. Article 17 Notification by the participating Member States 1. The participating Member States shall notify the Commission of the measures adopted in accordance with Article 9 by the date of application of this Regulation. 2. Each participating Member State shall notify the Commission of the measures adopted in accordance with Article 4(2) by the date of application of this Regulation or, in the case of a participating Member State in which the Unified Patent Court does not have exclusive jurisdiction with regard to European patents with unitary effect on the date of application of this Regulation, by the date from which the Unified Patent Court has such exclusive jurisdiction in that participating Member State. Article 18 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 1 January 2014 or the date of entry into force of the Agreement on a Unified Patent Court (the \u2018Agreement\u2019), whichever is the later. By way of derogation from Articles 3(1), 3(2) and 4(1), a European patent for which unitary effect is registered in the Register for unitary patent protection shall have unitary effect only in those participating Member States in which the Unified Patent Court has exclusive jurisdiction with regard to European patents with unitary effect at the date of registration. 3. Each participating Member State shall notify the Commission of its ratification of the Agreement at the time of deposit of its ratification instrument. The Commission shall publish in the Official Journal of the European Union the date of entry into force of the Agreement and a list of the Member States who have ratified the Agreement at the date of entry into force. The Commission shall thereafter regularly update the list of the participating Member States which have ratified the Agreement and shall publish such updated list in the Official Journal of the European Union. 4. The participating Member States shall ensure that the measures referred to in Article 9 are in place by the date of application of this Regulation. 5. Each participating Member State shall ensure that the measures referred to in Article 4(2) are in place by the date of application of this Regulation or, in the case of a participating Member State in which the Unified Patent Court does not have exclusive jurisdiction with regard to European patents with unitary effect on the date of application of this Regulation, by the date from which the Unified Patent Court has such exclusive jurisdiction in that participating Member State. 6. Unitary patent protection may be requested for any European patent granted on or after the date of application of this Regulation. This Regulation shall be binding in its entirety and directly applicable in the participating Member States in accordance with the Treaties. Done at Brussels, 17 December 2012. For the European Parliament The President M. SCHULZ For the Council The President A. D. MAVROYIANNIS (1) OJ L 76, 22.3.2011, p. 53. (2) Position of the European Parliament of 11 December 2012 (not yet published in the Official Journal) and decision of the Council of 17 December 2012. (3) See page 89 of this Official Journal. (4) OJ L 157, 30.4.2004, p. 45.", "summary": "Single EU patent boosts intellectual property protection and cuts related costs Single EU patent boosts intellectual property protection and cuts related costs Under the new EU Patent (unitary patent protection), inventors may submit a single application to protect their invention in 25 Member States. The scheme also makes access to patent protection easier, less costly and legally secure. ACT 1257/2012 of the European Parliament and of the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection. SUMMARY The EU Regulation 1257/2012 on unitary patent protection (UPP) extends the European patent system, enabling an invention to be protected in all of the 25 participating Member States with just one application. The new patent could reduce patent translation and related costs by up to 80%, with a single annual renewal fee to the European Patent Office (EPO). Patents to date in Europe have either been granted nationally or by the EPO. However, if a European patent is to be effective in a Member State, the patent holder must request validation in each country where patent protection is sought. Translation and annual renewal fees for these patents can be costly and are an overall burden for the EU. As outlined in this regulation, the EU Patent aims to end the complexity and expense of the current European patent system. For example: Holders of European patents can apply for the EU Patent for the territory of 25 Member States at the EPO. This patent will offer the same level of protection for their inventions in all those countries. Patent applications can be submitted to the EPO in any language. However applicants will also have to provide a translation in one of the EPO's three official languages (English, French or German). Applicants can claim compensation if they are EU-based businesses, individuals, non-profit organisations, universities and public research bodies. The patent claims defining the scope of protection must be translated into the other two official languages of the EPO. Lastly, for a transitional period of no more than 12 years, European patents with a unitary effect that were granted in French or German will need to be translated to English; those granted in English will need to be translated to another official language of the EU. These translations will be required until high-quality machine translations into all EU languages become available. Enhanced cooperation Both this regulation and EU Regulation 1260/2012 on translation arrangements for UPP were adopted by 25 Member States under the enhanced cooperation* procedure. Non-participating Member States can join later. Unified Patent Court The patent reform package includes an Agreement on a Unified Patent Court. Established under an international agreement signed on 19 February 2013, this court will have specialised jurisdiction in patent disputes, thus avoiding costly multiple litigation in up to 28 different national courts. * This allows EU Member States willing to work towards a common goal to do so outside of traditional Union collaboration, in this case through an intergovernmental treaty. REFERENCES Act Entry into force Deadline for incorporation into national law Official Journal 1257/2012 20.1.2013Application: from 01/01/2014 or the date of entry into force of the Agreement on a Unified Patent Court, whichever is the later. - OJ L 361 31.12.2012 RELATED ACTS 1260/2012 of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements. [Official Journal L 361 of 31.12.2012] Agreement on a Unified Patent Court [Official Journal C 175 of 20.6.2013] Last updated: 04.03.2014"}
{"article": "16.5.2012 EN Official Journal of the European Union L 129/1 REGULATION (EU) No 386/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 19 April 2012 on entrusting the Office for Harmonization in the Internal Market (Trade Marks and Designs) with tasks related to the enforcement of intellectual property rights, including the assembling of public and private-sector representatives as a European Observatory on Infringements of Intellectual Property Rights (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and the first paragraph of Article 118 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The economic well-being of the Union relies on sustained creativity and innovation. Therefore, measures for their effective protection are indispensable in ensuring its future prosperity. (2) Intellectual property rights are vital business assets that help to ensure that creators and innovators get a fair return for their work and that their investment in research and new ideas is protected. (3) A sound, harmonised and progressive approach to intellectual property rights is fundamental in the endeavour to fulfil the ambitions of the Europe 2020 Strategy including A Digital Agenda for Europe. (4) The constant increase in infringements of intellectual property rights constitutes a genuine threat not only to the Union economy, but also, in many cases, to the health and safety of Union consumers. Therefore, effective, immediate and coordinated action at national, European and global levels is needed to successfully combat this phenomenon. (5) In the context of the overall intellectual property rights strategy envisaged by the Council Resolution of 25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan (3), the Council called on the Commission to set up a European Observatory on Counterfeiting and Piracy. The Commission therefore formed a network of experts from the public and the private sectors and described the tasks of that network in its Communication entitled \u2018Enhancing the enforcement of intellectual property rights in the internal market\u2019. The name of the European Observatory on Counterfeiting and Piracy should be changed to the European Observatory on Infringements of Intellectual Property Rights (\u2018the Observatory\u2019). (6) That Communication stated that the Observatory should serve as the central resource for gathering, monitoring and reporting information and data related to all infringements of intellectual property rights. It should be used as a platform for cooperation between representatives from national authorities and stakeholders to exchange ideas and expertise on best practices and make recommendations to policymakers for joint enforcement strategies. The Communication specified that the Observatory would be hosted and managed by the services of the Commission. (7) In its Resolution of 1 March 2010 on the enforcement of intellectual property rights in the internal market (4), the Council invited the Commission, the Member States and industry to provide the Observatory with available reliable and comparable data on counterfeiting and piracy and to jointly develop and agree, in the context of the Observatory, on plans to collect further information. The Council also invited the Observatory to publish each year a comprehensive annual report covering the scope, scale and principal characteristics of counterfeiting and piracy as well as its impact on the internal market. That annual report should be prepared using the relevant information provided in that regard by the authorities of the Member States, the Commission and the private sector within the limits of data protection law. The Council also recognised the importance of developing new competitive business models enlarging the legal offer of cultural and creative content and at the same time preventing and combating infringements of intellectual property rights as necessary means for fostering economic growth, employment and cultural diversity. (8) In its Conclusions of 25 May 2010 on the future revision of the Trade Mark system in the European Union (5), the Council called on the Commission to establish a legal basis for the involvement of the Office for Harmonization in the Internal Market (Trade Marks and Designs) (\u2018the Office\u2019) in enforcement-related activities, including the fight against counterfeiting, in particular through fostering its cooperation with the national trade mark offices and the Observatory. In that respect, Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (6) provides, inter alia, for certain measures to promote cooperation, including the exchange of information, among Member States and between Member States and the Commission. (9) In its Recommendation of 26 March 2009 on strengthening security and fundamental freedoms on the internet (7), the European Parliament recommended that the Council preserve full and safe access to the internet while encouraging private/public cooperation in enhancing law enforcement cooperation. (10) In its Resolution of 22 September 2010 on enforcement of intellectual property rights in the internal market (8), the European Parliament called on the Member States and the Commission to extend the cooperation between the Office and national intellectual property offices so as to include the fight against infringements of intellectual property rights. (11) In its Resolution of 12 May 2011 on unlocking the potential of cultural and creative industries (9), the European Parliament urged the Commission to take into account the specific problems encountered by small and medium-sized enterprises when it comes to asserting their intellectual property rights and to promote best practice and effective methods to respect those rights. (12) In its Resolution of 6 July 2011 on a comprehensive approach on personal data protection in the European Union (10), the European Parliament called on the Commission to ensure full harmonisation and legal certainty, providing a uniform and high level of protection of individuals in all circumstances. (13) In view of the range of tasks assigned to the Observatory, a solution is needed to ensure an adequate and sustainable infrastructure for the fulfilment of its tasks. (14) Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (11) provides for administrative cooperation between the Office and the courts or authorities of the Member States, and the exchange of publications between the Office and the central industrial property offices of the Member States. On that basis, the Office has established cooperation with national offices that are active in the field of protection of intellectual property rights. Consequently, the Office already possesses, to a considerable extent, the necessary experience and expertise to provide an adequate and sustainable infrastructure in the field of the Observatory\u2019s tasks. (15) The Office is therefore well placed to be entrusted with carrying out those tasks. (16) Those tasks should relate to all intellectual property rights covered by Directive 2004/48/EC, since in many cases, infringing acts affect a bundle of intellectual property rights. Furthermore, data and the exchange of best practices are needed on the entire abovementioned range of intellectual property rights, in order to obtain a complete picture of the situation and to enable comprehensive strategies to be devised with a view to reducing infringements of intellectual property rights. (17) The tasks that the Office should carry out can be linked to the enforcement and reporting measures laid down by Directive 2004/48/EC. Thus, the Office should provide services to national authorities or operators which affect, in particular, the homogenous implementation of the Directive and which are likely to facilitate its application. The Office\u2019s tasks should therefore be considered as closely linked to the subject matter of acts approximating the laws, regulations and administrative provisions of the Member States. (18) Assembled by the Office, the Observatory should become a centre of excellence on information and data relating to infringements of intellectual property rights, by benefiting from the Office\u2019s expertise, experience and resources. (19) The Office should offer a forum that brings together public authorities and the private sector, ensuring the collection, analysis and dissemination of relevant objective, comparable and reliable data regarding the value of intellectual property rights and infringements of those rights, identifying and promoting best practices and strategies to enforce intellectual property rights, and raising public awareness of the impact of infringements of intellectual property rights. Furthermore, the Office should fulfil additional tasks, such as improving the understanding of the value of intellectual property rights, fostering the exchange of information on new competitive business models which enlarge the legal offer of cultural and creative content, enhancing the expertise of persons involved in the enforcement of intellectual property rights by appropriate training measures, increasing knowledge of techniques to prevent counterfeiting, and improving cooperation with third countries and international organisations. The Commission should be associated with the activities undertaken by the Office under this Regulation. (20) The Office should thus facilitate and support the activities of national authorities, the private sector and the Union institutions relating to the enforcement of intellectual property rights and in particular their activities in the fight against infringements of those rights. The exercise by the Office of its powers under this Regulation does not prevent Member States from exercising their competences. The Office\u2019s tasks and activities under this Regulation do not extend to participation in individual operations or investigations carried out by the competent authorities. (21) In order to fulfil those tasks in the most efficient manner, the Office should consult and cooperate with other authorities at national, European and, where appropriate, international levels, create synergies with the activities carried out by such authorities and avoid any duplication of measures. (22) The Office should implement the tasks and activities relating to the enforcement of intellectual property rights by making use of its own budgetary means. (23) With regard to representatives of the private sector, the Office should, when assembling the Observatory in the context of its activities, involve a representative selection of the economic sectors \u2014 including the creative industries \u2014 most concerned by or most experienced in the fight against infringements of intellectual property rights, in particular representatives of right holders, including authors and other creators, as well as internet intermediaries. Also, a proper representation of consumers and of small and medium-sized enterprises should be ensured. (24) The information obligations imposed by this Regulation on the Member States and on the private sector should not create unnecessary administrative burdens and should endeavour to avoid duplication as regards data already provided by Member States and private-sector representatives to Union institutions under existing Union reporting requirements. (25) Since the objective of this Regulation, namely to entrust the Office with tasks related to the enforcement of intellectual property rights, cannot be sufficiently achieved by the Member States and can therefore, by reason of its effect, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope This Regulation entrusts the Office for Harmonization in the Internal Market (Trade Marks and Designs) (\u2018the Office\u2019) with tasks aimed at facilitating and supporting the activities of national authorities, the private sector and the Union institutions in the fight against infringements of the intellectual property rights covered by Directive 2004/48/EC. In carrying out these tasks the Office shall organise, administer and support the gathering of experts, authorities and stakeholders assembled under the name \u2018European Observatory on Infringements of Intellectual Property Rights\u2019 (\u2018the Observatory\u2019). The tasks and activities of the Office under this Regulation do not extend to participation in individual operations or investigations carried out by the competent authorities. Article 2 Tasks and activities 1. The Office shall have the following tasks: (a) improving understanding of the value of intellectual property; (b) improving understanding of the scope and impact of infringements of intellectual property rights; (c) enhancing knowledge of best public and private sector practices to protect intellectual property rights; (d) assisting in raising citizens\u2019 awareness of the impact of infringements of intellectual property rights; (e) enhancing the expertise of persons involved in the enforcement of intellectual property rights; (f) enhancing knowledge of technical tools to prevent and tackle infringements of intellectual property rights, including tracking and tracing systems which help to distinguish genuine products from counterfeit ones; (g) providing mechanisms which help to improve the online exchange, between Member States\u2019 authorities working in the field of intellectual property rights, of information relating to the enforcement of such rights, and fostering cooperation with and between those authorities; (h) working, in consultation with Member States, to foster international cooperation with intellectual property offices in third countries so as to build strategies and develop techniques, skills and tools for the enforcement of intellectual property rights. 2. In the fulfilment of the tasks set out in paragraph 1, the Office shall carry out the following activities in accordance with the work programme adopted pursuant to Article 7, and in line with Union law: (a) establishing a transparent methodology for the collection, analysis and reporting of independent, objective, comparable and reliable data relating to infringements of intellectual property rights; (b) collecting, analysing and disseminating relevant objective, comparable and reliable data regarding infringements of intellectual property rights; (c) collecting, analysing and disseminating relevant objective, comparable and reliable data regarding the economic value of intellectual property and its contribution to economic growth, welfare, innovation, creativity, cultural diversity, the creation of high-quality jobs and the development of high quality products and services within the Union; (d) providing regular assessments and specific reports by economic sector, geographic area and type of intellectual property right infringed, which evaluate, inter alia, the impact of infringements of intellectual property rights on society and the economy, including an assessment of the effects on small and medium-sized enterprises, as well as on health, the environment, safety and security; (e) collecting, analysing and disseminating information regarding best practices between the representatives meeting as the Observatory, and, if applicable, making recommendations for strategies based on such practices; (f) drawing up reports and publications to raise awareness amongst Union citizens of the impact of infringements of intellectual property rights and to that end, organising conferences, events and meetings at European and international levels as well as assisting national and Europe-wide actions, including online and offline campaigns, principally by providing data and information; (g) monitoring the development of new competitive business models which enlarge the legal offer of cultural and creative content, and encouraging the exchange of information and raising consumer awareness in this respect; (h) developing and organising online and other forms of training for national officials involved in the protection of intellectual property rights; (i) organising ad hoc meetings of experts, including academic experts and relevant representatives of civil society, to support its work under this Regulation; (j) identifying and promoting technical tools for professionals and benchmark techniques, including tracking and tracing systems which help to distinguish genuine products from counterfeit ones; (k) working with national authorities and the Commission to develop an online network facilitating the exchange of information on infringements of intellectual property rights between public administrations, bodies and organisations in the Member States dealing with the protection and enforcement of those rights; (l) working in cooperation with, and building synergies between, the central industrial property offices of the Member States, including the Benelux Office for Intellectual Property and other Member States\u2019 authorities working in the field of intellectual property rights, with a view to developing and promoting techniques, skills and tools relating to the enforcement of intellectual property rights, including training programmes and awareness campaigns; (m) developing, in consultation with the Member States, programmes for the provision of technical assistance to third countries as well as developing and delivering specific training programmes and events for officials from third countries who are involved in the protection of intellectual property rights; (n) making recommendations to the Commission on issues falling within the scope of this Regulation, on the basis of a request from the Commission; (o) carrying out similar activities necessary in order to enable the Office to fulfil the tasks set out in paragraph 1. 3. In carrying out the tasks and activities referred to in paragraphs 1 and 2, the Office shall comply with existing provisions of Union law on data protection. Article 3 Financing The Office shall at all times ensure that the activities entrusted to it by this Regulation are carried out by making use of its own budgetary means. Article 4 Meetings of the Observatory 1. In order to carry out the activities referred to in Article 2(2), the Office shall at least once per year invite to meetings of the Observatory representatives from public administrations, bodies and organisations in the Member States dealing with intellectual property rights and representatives from the private sector, for the purpose of their participation in the Office\u2019s work under this Regulation. 2. Private-sector representatives invited to meetings of the Observatory shall include a broad, representative and balanced range of Union and national bodies representing the different economic sectors, including the creative industries, most concerned by or most experienced in the fight against infringements of intellectual property rights. Consumer organisations, small and medium-sized enterprises, authors and other creators shall be properly represented. 3. The Office shall invite each Member State to send at least one representative from its public administration to meetings of the Observatory. In that context, Member States shall ensure continuity in the Observatory\u2019s work. 4. The meetings referred to in paragraph 1 may be complemented by working groups within the Observatory made up of representatives from Member States and representatives from the private sector. 5. Where appropriate, and in addition to the meetings referred to in paragraph 1, the Office shall organise meetings consisting of: (a) representatives from the public administrations, bodies and organisations in the Member States; or (b) private-sector representatives. 6. Members or other representatives of the European Parliament and representatives from the Commission shall be invited to any of the meetings covered by this Article, either as participants or observers, as appropriate. 7. The names of the representatives attending, the agenda and the minutes of the meetings referred to in this Article shall be published on the Office\u2019s website. Article 5 Information obligations 1. As appropriate, in accordance with national law, including the law governing the processing of personal data, Member States shall, at the request of the Office or on their own initiative: (a) inform the Office of their overall policies and strategies on the enforcement of intellectual property rights and any changes thereto; (b) provide available statistical data on infringements of intellectual property rights; (c) inform the Office of important case-law. 2. Without prejudice to the law governing the processing of personal data and to the protection of confidential information, private-sector representatives meeting as the Observatory shall, when possible, at the request of the Office: (a) inform the Office of policies and strategies in their field of activity on the enforcement of intellectual property rights and any changes thereto; (b) provide statistical data on infringements of intellectual property rights in their field of activity. Article 6 The Office 1. The relevant provisions of Title XII of Regulation (EC) No 207/2009 shall apply to the carrying-out of the tasks and activities provided for under this Regulation. 2. Using the powers conferred by Article 124 of Regulation (EC) No 207/2009, the President of the Office shall adopt the internal administrative instructions and shall publish the notices that are necessary for the fulfilment of all the tasks entrusted to the Office by this Regulation. Article 7 Content of the work programme and of the management report 1. The Office shall draw up an annual work programme that appropriately prioritises the activities under this Regulation and for the meetings of the Observatory, in line with the Union\u2019s policies and priorities in the field of protection of intellectual property rights and in cooperation with the representatives referred to in point (a) of Article 4(5). 2. The work programme referred to in paragraph 1 shall be submitted to the Office\u2019s Administrative Board for information. 3. The management report provided for in point (d) of Article 124(2) of Regulation (EC) No 207/2009 shall contain at least the following information concerning the Office\u2019s tasks and activities under this Regulation: (a) a review of the main activities carried out during the preceding calendar year; (b) the results achieved during the preceding calendar year, accompanied, where appropriate, by sectoral reports analysing the situation in the different industry and product sectors; (c) an overall assessment of the fulfilment of the Office\u2019s tasks as provided for in this Regulation and in the work programme drawn up in accordance with paragraph 1; (d) an overview of the activities that the Office intends to undertake in the future; (e) observations on the enforcement of intellectual property rights and potential future policies and strategies, including on how to enhance effective cooperation with and between Member States; (f) an overall assessment of the proper representation in the Observatory of all the actors mentioned in Article 4(2). Before submitting the management report to the European Parliament, the Commission and the Administrative Board, the President of the Office shall consult the representatives referred to in point (a) of Article 4(5) on the relevant parts of the report. Article 8 Evaluation 1. The Commission shall adopt a report evaluating the application of this Regulation by 6 June 2017. 2. The evaluation report shall assess the operation of this Regulation, in particular as regards its impact on the enforcement of intellectual property rights in the internal market. 3. The Commission shall, when preparing the evaluation report, consult the Office, the Member States and the representatives meeting as the Observatory on the issues referred to in paragraph 2. 4. The Commission shall transmit the evaluation report to the European Parliament, the Council and the European Economic and Social Committee and shall undertake a broad consultation among stakeholders on the evaluation report. Article 9 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 19 April 2012. For the European Parliament The President M. SCHULZ For the Council The President M. B\u00d8DSKOV (1) OJ C 376, 22.12.2011, p. 62. (2) Position of the European Parliament of 14 February 2012 (not yet published in the Official Journal) and decision of the Council of 22 March 2012 (not yet published in the Official Journal). (3) OJ C 253, 4.10.2008, p. 1. (4) OJ C 56, 6.3.2010, p. 1. (5) OJ C 140, 29.5.2010, p. 22. (6) OJ L 157, 30.4.2004, p. 45. Corrected version in OJ L 195, 2.6.2004, p. 16. (7) OJ C 117 E, 6.5.2010, p. 206. (8) OJ C 50 E, 21.2.2012, p. 48. (9) Not yet published in the Official Journal. (10) Not yet published in the Official Journal. (11) OJ L 78, 24.3.2009, p. 1.", "summary": "Intellectual property rights infringements Intellectual property rights infringements SUMMARY OF: Regulation (EU) No 386/2012 on the European Observatory on Infringements of Intellectual Property Rights WHAT IS THE AIM OF THIS REGULATION? It entrusts the EU Intellectual Property Office, EUIPO (formerly the Office for Harmonization in the Internal Market, OHIM), with tasks supporting the activities of national authorities, the private sector and EU institutions in the fight against infringements of intellectual property rights (IPR) covered by Directive 2004/48/EC. KEY POINTS EUIPO is responsible for bringing together experts, authorities and stakeholders under the umbrella of the European Observatory on Infringements of Intellectual Property Rights (the observatory), although its tasks do not extend to participation in individual operations or investigations carried out by the competent authorities. It has the following tasks: improving understanding of the value of intellectual property; improving understanding of the scope and impact of IPR infringements; enhancing knowledge of best public and private sector practices to protect IPR; helping to raise citizens\u2019 awareness of the impact of IPR infringements; enhancing the expertise of persons involved in IPR enforcement; enhancing knowledge of technical tools to prevent and tackle IPR infringements, including tracking and tracing systems which help to distinguish genuine products from counterfeit ones; providing mechanisms which help to improve the online exchange, between EU countries working on IPR, of information relating to enforcement, and fostering cooperation; working, in consultation with EU countries, to foster international cooperation with IPR bodies in non-EU countries to build strategies and develop techniques, skills and tools for IPR enforcement. Observatory meetings At least once a year, EUIPO will host meetings of representatives from public administrations and organisations from EU countries dealing with IPR and a broad, representative and balanced range of private-sector representatives most concerned by or most experienced in the fight against IPR infringements (rights holders, including authors and other creators) as well as internet intermediaries. Consumer organisations, small and medium-sized enterprises, authors and other creators must be properly represented. Representatives of the European Parliament and from the European Commission are invited to participate or observe, as appropriate. Private-sector representatives meeting as part of the observatory are expected to keep EUIPO informed of their IPR-enforcement policies and strategies and to provide statistical data on infringements in their field of activity. Work programme EUIPO will draw up an annual work programme prioritising the observatory\u2019s activities set out in the regulation and for the observatory meetings, in line with the EU's IPR policies and priorities and in cooperation with representatives from the observatory. Management report The annual management report contains at least the following information concerning EUIPO\u2019s tasks and activities under this regulation: a review of the main activities carried out during the year; the results achieved during the year, accompanied by reports analysing the situation in the different industry and product sectors; an overall assessment of the fulfilment of EUIPO\u2019s tasks; an overview of future activities; observations on the enforcement of IPR and potential future policies and strategies, including how to enhance effective cooperation with and between EU countries; an overall assessment of representation in the observatory. Evaluation A report will evaluate the regulation\u2019s application with particular regard to its impact on IPR enforcement in the EU\u2019s single market. FROM WHEN DOES THIS REGULATION APPLY? It applies from 5 June 2012. BACKGROUND For more information, see: Enforcement of intellectual property rights (European Commission) Counterfeit, piracy and other IPR violations (European Commission). MAIN DOCUMENT Regulation (EU) No 386/2012 of the European Parliament and of the Council of 19 April 2012 on entrusting the Office for Harmonization in the Internal Market (Trade Marks and Designs) with tasks related to the enforcement of intellectual property rights, including the assembling of public and private-sector representatives as a European Observatory on Infringements of Intellectual Property Rights (OJ L 129, 16.5.2012, pp. 1-6) RELATED DOCUMENTS Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (codification) (OJ L 154, 16.6.2017, pp. 1-99) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions \u2014 A Single Market for Intellectual Property Rights: Boosting creativity and innovation to provide economic growth, high quality jobs and first class products and services in Europe (COM(2011) 287 final, 24.5.2011) Council resolution of 25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan (OJ C 253, 4.10.2008, pp. 1-2) Directive 2004/48/EC of the European Parliament and of the Council on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, pp. 45-86). Text republished in corrigendum (OJ L 195, 2.6.2004, pp. 16-25). See consolidated version. last update 06.12.2017"}
{"article": "27.6.2014 EN Official Journal of the European Union L 189/50 REGULATION (EU) No 654/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 concerning the exercise of the Union's rights for the application and enforcement of international trade rules and amending Council Regulation (EC) No 3286/94 laying down Community procedures in the field of the common commercial policy in order to ensure the exercise of the Community's rights under international trade rules, in particular those established under the auspices of the World Trade Organization THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 (2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) The Union has concluded a number of multilateral, regional and bilateral international trade agreements creating rights and obligations for the mutual benefit of the parties. (2) It is essential that the Union possess appropriate instruments to ensure the effective exercise of the Union's rights under international trade agreements in order to safeguard its economic interests. This is particularly the case in situations where third countries enact trade restrictive measures that diminish the benefits accruing to the Union's economic operators under international trade agreements. The Union should be in a position to react swiftly and in a flexible manner in the context of the procedures and deadlines set out by the international trade agreements which it has concluded. There is therefore a need for rules defining the framework for exercising the Union's rights in certain specific situations. (3) The dispute settlement mechanisms set up by the Agreement establishing the World Trade Organization (WTO) and by other international trade agreements, including regional or bilateral agreements, aim at finding a positive solution to any disputes arising between the Union and the other party or parties to those agreements. The Union should, nevertheless, be able to suspend concessions or other obligations, in accordance with those dispute settlement mechanisms, when other avenues to find a positive solution to a dispute have proven unsuccessful. Action by the Union in such cases should serve the purpose of inducing compliance of the third country concerned with the relevant international trade rules in order to restore a situation of reciprocal benefits. (4) Under the WTO Agreement on Safeguards, a WTO member proposing to apply a safeguard measure or seeking an extension of a safeguard measure has to endeavour to maintain a substantially equivalent level of concessions and other obligations between it and the exporting Members, which would be affected by such a measure. Similar rules are laid down in other international trade agreements concluded by the Union, including regional or bilateral agreements. The Union should take rebalancing measures by suspending concessions or other obligations in cases where the third country concerned implements no adequate and proportionate adjustments. Action by the Union in such cases should serve the purpose of inducing the introduction of trade-enhancing measures by third countries in order to restore a situation of reciprocal benefits. (5) Article XXVIII of the General Agreement on Tariffs and Trade 1994 (GATT 1994) and the related Understanding govern the modification or withdrawal of concessions established in the tariff schedules of WTO Members. WTO Members affected by any such modification are entitled, under certain conditions, to withdraw substantially equivalent concessions. The Union should adopt rebalancing measures in such cases, unless compensatory adjustments are agreed. Action by the Union should be aimed at inducing third countries to implement trade-enhancing measures. (6) The Union should have the possibility to enforce its rights in the area of public procurement when a trade partner fails to respect its commitments under the WTO Agreement on Government Procurement (GPA) or other international trade agreements. The GPA states that any dispute arising thereunder is not to result in the suspension of concessions or other obligations under any other covered agreement of the WTO. The Union's action should be aimed at ensuring the maintenance of a substantially equivalent level of concessions, as laid down in the relevant international trade agreements. (7) Member States should ensure the application within their respective territories of commercial policy measures in the field of public procurement in the manner that is best suited to their administrative structures and practices, while respecting Union law. (8) Commercial policy measures adopted under this Regulation should be selected and designed on the basis of objective criteria, including the effectiveness of the measures in inducing compliance of third countries with international trade rules, their potential to provide relief to economic operators within the Union affected by third country measures, and the aim of minimising negative economic impacts on the Union, including with regard to essential raw materials. (9) This Regulation should focus on those measures in respect of which the Union has experience in design and application. The possibility to extend its scope in order to provide for the adoption of measures in the sector of intellectual property rights and additional measures concerning services should be assessed as part of the review on the functioning of this Regulation, with due regard to the specificities of each area. (10) When enforcing the Union's rights, the origin of a good should be determined in accordance with Council Regulation (EEC) No 2913/92 (2). When enforcing the Union's rights following dispute settlement in the area of public procurement, the origin of a service should be determined on the basis of the origin of the natural or legal person providing it. Contracting authorities or entities should apply normal precautions and exercise due diligence when assessing information and guarantees provided by tenderers as regards the origin of goods and services. (11) The Commission should review the scope, functioning and efficiency of this Regulation, including possible measures in the sector of intellectual property rights and additional measures concerning services, no later than three years after the first instance of its implementation or no later than five years from its date of entry into force, whichever is the earlier. The Commission should report on its assessment to the European Parliament and the Council. The review may be followed up by appropriate legislative proposals. (12) It is important to ensure an effective communication and exchange of views between the Commission on the one hand and the European Parliament and the Council on the other, in particular on disputes under international trade agreements that may lead to the adoption of measures under this Regulation. (13) Council Regulation (EC) No 3286/94 (3) should be amended in order to refer to this Regulation with regard to the implementation of commercial policy measures. (14) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (4). (15) In light of the high complexity involved in the examination of the multiple impacts that commercial policy measures adopted under this Regulation may have, and with a view to allowing sufficient opportunities to achieve the widest possible support, implementing acts should not be adopted by the Commission where, exceptionally, the committee referred to in this Regulation delivers no opinion on the draft implementing act presented by the Commission. (16) In order to safeguard the Union's interests, the Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the need to adapt commercial policy measures to the behaviour of the third party concerned, imperative grounds of urgency so require. (17) This Regulation is without prejudice to the possible adoption of commercial policy measures on the basis of other relevant Union acts or of the provisions of the Treaty on the Functioning of the European Union, while respecting the applicable provisions in international trade agreements on the suspension or withdrawal of concessions or other obligations, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation lays down rules and procedures to ensure an effective and timely exercise of the Union's rights to suspend or withdraw concessions or other obligations under international trade agreements, with the intention of: (a) responding to breaches by third countries of international trade rules which affect the Union's interests, with a view to seeking a satisfactory solution that restores benefits for the Union's economic operators; (b) rebalancing concessions or other obligations in the trade relations with third countries, when the treatment accorded to goods from the Union is altered in a way that affects the Union's interests. Article 2 Definitions For the purposes of this Regulation the following definitions apply: (a) \"country\" means any State or separate customs territory; (b) \"concessions or other obligations\" means tariff concessions or any other benefits that the Union has committed itself to applying in its trade with third countries by virtue of international trade agreements to which it is a party; (c) \"level of nullification or impairment\" means the degree to which the benefits accruing to the Union under an international trade agreement are affected. Except as otherwise defined in the relevant agreement, it includes any adverse economic impact resulting from a third country measure; (d) \"mandatory price penalty\" means an obligation on contracting authorities or entities conducting public procurement procedures to increase, subject to certain exceptions, the price of services and/or goods originating in certain third countries that have been offered in contract award procedures. Article 3 Scope This Regulation applies: (a) following the adjudication of trade disputes under the WTO Understanding on Rules and Procedures Governing the Settlement of Disputes (WTO Dispute Settlement Understanding), when the Union has been authorised to suspend concessions or other obligations under the multilateral and plurilateral agreements covered by the WTO Dispute Settlement Understanding; (b) following the adjudication of trade disputes under other international trade agreements, including regional or bilateral agreements, when the Union has the right to suspend concessions or other obligations under such agreements; (c) for the rebalancing of concessions or other obligations, to which the application of a safeguard measure by a third country may give right pursuant to Article 8 of the WTO Agreement on Safeguards, or to the provisions on safeguards included in other international trade agreements, including regional or bilateral agreements; (d) in cases of modification of concessions by a WTO member under Article XXVIII of the GATT 1994, where no compensatory adjustments have been agreed. Article 4 Exercise of the Union's rights 1. Where action is necessary to safeguard the Union's interests in the cases referred to in Article 3, the Commission shall adopt implementing acts determining the appropriate commercial policy measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 8(2). 2. Implementing acts adopted pursuant to paragraph 1 shall meet the following conditions: (a) where concessions or other obligations are suspended following the adjudication of a trade dispute under the WTO Dispute Settlement Understanding, their level shall not exceed the level authorised by the WTO Dispute Settlement Body; (b) where concessions or other obligations are suspended following the discharge of an international dispute settlement procedure under other international trade agreements, including regional or bilateral agreements, their level shall not exceed the level of nullification or impairment as a result of the third country measure concerned, as determined by the Commission or through recourse to arbitration, as the case may be; (c) in the case of rebalancing of concessions or other obligations under provisions on safeguards in international trade agreements, the Union's action shall be substantially equivalent to the level of concessions or other obligations affected by the safeguard measure, in accordance with the conditions of the WTO Agreement on Safeguards or of the provisions on safeguards in other international trade agreements, including regional or bilateral agreements, under which the safeguard measure is applied; (d) where concessions are withdrawn in the trade with a third country in connection with Article XXVIII of the GATT 1994 and the related Understanding (5), they shall be substantially equivalent to the concessions modified or withdrawn by that third country, in accordance with the terms established in Article XXVIII of the GATT 1994 and the related Understanding. 3. Commercial policy measures referred to in paragraph 1 shall be determined on the basis of the following criteria, in light of available information and of the Union's general interest: (a) effectiveness of the measures in inducing compliance of third countries with international trade rules; (b) potential of the measures to provide relief to economic operators within the Union affected by third country measures; (c) availability of alternative sources of supply for the goods or services concerned, in order to avoid or minimise any negative impact on downstream industries, contracting authorities or entities, or final consumers within the Union; (d) avoidance of disproportionate administrative complexity and costs in the application of the measures; (e) any specific criteria that may be established in international trade agreements in connection with the cases referred to in Article 3. Article 5 Commercial policy measures 1. Without prejudice to any international agreement to which the Union is a party, the commercial policy measures that may be enacted by means of an implementing act pursuant to Article 4(1) shall consist of: (a) the suspension of tariff concessions and the imposition of new or increased customs duties, including the re-establishment of customs duties at the most favoured nation level or the imposition of customs duties beyond the most favoured nation level, or the introduction of any additional charge on imports or exports of goods; (b) the introduction or increase of quantitative restrictions on imports or exports of goods, whether made effective through quotas, import or export licences or other measures; (c) the suspension of concessions regarding goods, services or suppliers in the area of public procurement, through: (i) the exclusion from public procurement of suppliers of goods or services established in and operating from the third country concerned and/or of tenders the total value of which is made up of more than 50 % of goods or services originating in the third country concerned; and/or (ii) the imposition of a mandatory price penalty on tenders of suppliers of goods or services established in and operating from the third country concerned and/or on that part of the tender consisting of goods or services originating in the third country concerned. 2. Measures adopted pursuant to paragraph 1(c) shall: (a) include thresholds, according to the characteristics of the goods or services concerned, above which the exclusion and/or mandatory price penalty is to apply, taking into account the provisions of the trade agreement concerned and the level of nullification or impairment; (b) determine the sectors or the categories of goods or services to which they apply, as well as any applicable exceptions; (c) determine the contracting authorities or entities or categories of contracting authorities or entities, listed by Member State, whose procurement is covered. To provide the basis for this determination, each Member State shall submit a list of appropriate contracting authorities or entities or categories of contracting authorities or entities. The measures shall ensure that an appropriate level of suspension of concessions or other obligations and a fair distribution among Member States is achieved. Article 6 Rules of origin 1. The origin of a good shall be determined in accordance with Regulation (EEC) No 2913/92. 2. The origin of a service shall be determined on the basis of the origin of the natural or legal person providing it. The origin of the service provider shall be deemed to be: (a) in the case of a natural person, the country of which the person is a national or where he has a right of permanent residence; (b) in the case of a legal person, either of the following: (i) if the service is provided other than through a commercial presence within the Union, the country where the legal person is constituted or otherwise organised under the laws of that country and in the territory of which the legal person is engaged in substantive business operations; (ii) if the service is provided through a commercial presence within the Union, the Member State where the legal person is established and in the territory of which it is engaged in substantive business operations such that it has a direct and effective link with the economy of that Member State. For the purposes of point (ii) of point (b) of the first subparagraph, if the legal person providing the service is not engaged in substantive business operations such that it has a direct and effective link with the economy of the Member State in which it is established, the origin of that legal person shall be deemed to be the origin of the natural or legal persons which own or control it. The legal person providing the service shall be considered to be \"owned\" by persons of a given country if more than 50 % of the equity interest in it is beneficially owned by persons of that country and \"controlled\" by persons of a given country if such persons have the power to name a majority of its directors or otherwise to legally direct its actions. Article 7 Suspension, modification and repeal of measures 1. Where, after the adoption of an implementing act pursuant to Article 4(1), the third country concerned accords adequate and proportionate compensation to the Union in the cases referred to in Article 3(1)(a) and (b), the Commission may suspend the application of that implementing act for the duration of the compensation period. The suspension shall be decided in accordance with the examination procedure referred to in Article 8(2). 2. The Commission shall repeal an implementing act adopted under Article 4(1) in any of the following circumstances: (a) when the third country whose measures were found to be in breach of international trade rules in a dispute settlement procedure brings itself into compliance, or where a mutually satisfactory solution has otherwise been reached; (b) in cases of rebalancing of concessions or other obligations following the adoption by a third country of a safeguard measure, when the safeguard measure is withdrawn or expires, or when the third country concerned accords adequate and proportionate compensation to the Union after the adoption of an implementing act under Article 4(1); (c) in cases of modification of concessions by a WTO member under Article XXVIII of the GATT 1994, when the third country concerned accords adequate and proportionate compensation to the Union after the adoption of an implementing act under Article 4(1). The repeal referred to in the first subparagraph shall be decided in accordance with the examination procedure referred to in Article 8(2). 3. Where it is necessary to make adjustments to commercial policy measures adopted under this Regulation, subject to Article 4(2) and (3), the Commission may introduce any appropriate amendments in accordance with the examination procedure referred to in Article 8(2). 4. On duly justified imperative grounds of urgency relating to the termination or the modification of the third country measure concerned, the Commission shall adopt immediately applicable implementing acts suspending, amending or repealing implementing acts adopted under Article 4(1), as provided for in this Article, in accordance with the procedure referred to in Article 8(3). Article 8 Committee procedure 1. The Commission shall be assisted by the committee established by Regulation (EC) No 3286/94. That committee shall be a committee within the meaning of Article 3 of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 in conjunction with Article 5 thereof, shall apply. Article 9 Information gathering 1. The Commission shall seek information and views regarding the Union's economic interests in specific goods or services or in specific sectors, in the application of this Regulation, through a notice in the Official Journal of the European Union or through other suitable public communication means, indicating the period within which input is to be submitted. The Commission shall take the input received into account. 2. Information received pursuant to this Regulation shall be used only for the purpose for which it was requested. 3. Neither the European Parliament, nor the Council, nor the Commission, nor Member States, nor their respective officials shall reveal any information of a confidential nature received pursuant to this Regulation, without specific permission from the supplier of such information. 4. The supplier of information may request that information supplied be treated as confidential. In such cases, it shall be accompanied by a non-confidential summary which presents the information in a generalised form or a statement of the reasons why the information cannot be summarised. 5. If it appears that a request for confidentiality is not justified and if the supplier is unwilling either to make the information public or to authorise its disclosure in generalised or summary form, the information in question may be disregarded. 6. Paragraphs 2 to 5 shall not preclude the disclosure of general information by the institutions of the Union and the authorities of the Member States. Such disclosure must take into account the legitimate interest of the parties concerned in not having their business secrets divulged. Article 10 Review 1. No later than three years after the first instance of the adoption of an implementing act or no later than 18 July 2019, whichever is the earlier, the Commission shall review the scope of this Regulation, particularly as regards the commercial policy measures that may be adopted, as well as its implementation, and shall report its findings to the European Parliament and the Council. 2. Notwithstanding paragraph 1, the Commission shall undertake a review aimed at envisaging under this Regulation additional commercial policy measures suspending concessions or other obligations in the field of trade in services. The Commission shall examine, inter alia, the following aspects: (a) international developments with regard to the suspension of other obligations under the General Agreement on Trade in Services (GATS); (b) developments within the Union with regard to the adoption of common rules on services sectors; (c) the effectiveness of possible additional commercial policy measures as a means to enforce the Union's rights under international trade agreements; (d) available mechanisms to ensure the practical implementation, in a uniform and efficient manner, of possible additional commercial policy measures concerning services; and (e) implications for service providers present in the Union at the time of adoption of implementing acts under this Regulation. The Commission shall report its initial assessment to the European Parliament and the Council by 18 July 2017. Article 11 Amendments to other acts In Article 13 of Regulation (EC) No 3286/94, paragraph 3 is replaced by the following: \"3. Where the Union, having acted in accordance with Article 12(2), has to take a decision on the measures of commercial policy to be adopted pursuant to Article 11(2)(c) or pursuant to Article 12, it shall act, without delay, in accordance with Article 207 of the Treaty on the Functioning of the European Union and, as appropriate, Regulation (EU) No 654/2014 of the European Parliament and of the Council (6) or any other applicable procedures. Article 12 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 May 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and decision of the Council of 8 May 2014. (2) Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (OJ L 302, 19.10.1992, p. 1). (3) Council Regulation (EC) No 3286/94 of 22 December 1994 laying down Community procedures in the field of the common commercial policy in order to ensure the exercise of the Community's rights under international trade rules, in particular those established under the auspices of the World Trade Organization (OJ L 349, 31.12.1994, p. 71). (4) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (5) Understanding \"Interpretation and Application of Article XXVIII\". Statement by the Commission The Commission welcomes the adoption of the Regulation of the European Parliament and of the Council concerning the exercise of the Union\u2019s rights for the application and enforcement of international trade rules and amending Council Regulation (EC) No 3286/94. Under the Regulation, the Commission is empowered to adopt implementing acts in certain specific situations, on the basis of objective criteria and subject to the control of the Member States. In exercising that empowerment, the Commission intends to act in accordance with this Declaration. When preparing draft implementing acts, the Commission will undertake extensive consultations with a view to ensuring that all relevant interests are duly taken into account. Through those consultations, the Commission expects to receive input from private stakeholders affected by third country measures or by possible commercial policy measures to be adopted by the Union. Similarly, the Commission expects to receive input from public authorities that may be involved in the implementation of possible commercial policy measures to be adopted by the Union. In the case of measures in the field of public procurement, in particular input from Member States\u2019 public authorities will be duly taken into account in the preparation of draft implementing acts. The Commission recognizes the importance of Member States receiving timely information when it is considering the adoption of implementing acts under this Regulation so as to enable them to contribute to fully informed decisions and will act to achieve this objective. The Commission confirms that it will promptly transmit to the Parliament and to the Council draft implementing acts that it submits to the committee of Member States. Similarly, it will promptly transmit to the Parliament and the Council final draft implementing acts following the delivery of opinions in the committee. The Commission will keep the Parliament and the Council regularly informed of international developments that may lead to situations requiring the adoption of measures under the Regulation. This will be done through the responsible committees in Council and in Parliament. The Commission welcomes the Parliament\u2019s intention to promote a structured dialogue on dispute settlement and enforcement issues and will fully engage in dedicated sessions with the responsible Parliamentary committee to exchange views on trade disputes and enforcement actions, including with regard to impacts on Union industries. Finally, the Commission confirms that it attaches great importance to ensuring that the Regulation is an effective and efficient tool for the enforcement of the Union\u2019s rights under international trade agreements, including in the field of trade in services. Therefore, the Commission will, in accordance with the provisions of the Regulation, review the scope of Article 5 with a view to covering additional commercial policy measures concerning trade in services as soon as the conditions for ensuring the workability and effectiveness of such measures are present.", "summary": "EU rights to apply and enforce international trade rules EU rights to apply and enforce international trade rules SUMMARY OF: Regulation (EU) No 654/2014 \u2014 the EU\u2019s rights to apply and enforce international trade rules \u2014 amending Regulation (EC) No 3286/94 laying down procedures to ensure the EU\u2019s rights under international trade rules WHAT IS THE AIM OF THE REGULATION? It ensures that the EU is able to enforce and exercise its rights under international trade agreements by adopting trade policy measures. KEY POINTS The regulation sets out rules and procedures for the EU to suspend or withdraw its obligations under an international trade agreement in order to: respond to breaches of international trade rules by non-EU countries and enforce a judicial ruling in favour of the EU, to obtain a satisfactory solution that restores benefits for EU businesses; rebalance obligations under and in line with a trade agreement, when non-EU countries alter the treatment of goods from the EU, either temporarily through a safeguard measure or long-term through modifying tariff concessions. Action To safeguard the EU\u2019s interests, the European Commission can adopt implementing acts to adapt its trade policy in response to the actions of the non-EU country concerned. In urgent cases, the Commission can immediately adopt applicable implementing acts. The Commission, assisted by the EU Member States, consults with relevant stakeholders before adopting these acts. Available trade policy measures These consist of: suspending tariff concessions and imposing new or increased customs duties; introducing or increasing quantitative restrictions (quotas) on imports or exports of goods; suspending concessions and introducing certain restrictions in the area of public procurement. Determining appropriate measures Trade policy measures are determined based on the following: effectiveness of the measures in inducing the non-EU country to comply with international trade rules; potential of the measures to provide relief to businesses within the EU affected by non-EU country measures; availability of alternative sources of supply for the goods or services concerned; avoiding disproportionate administrative complexity and costs in applying the measures; measures must be proportionate to and must not exceed the harm that they are introduced to counteract. Revision of the regulation Because a current lack of new appointments to the Appellate Body of the World Trade Organization (WTO) has meant that the second tier of its dispute settlement mechanism is not able to function, amending Regulation (EU) 2021/167 introduced some changes to Regulation (EU) No 654/2014. The amending Regulation (EU) 2021/167: allows enforcement action in situations where: the EU obtains a favourable ruling from a WTO dispute settlement panel,the process is then blocked because the non-EU country appeals to the non-functioning WTO Appellate Body, and does not agree to interim appeal arbitration under Article 25 of the WTO Dispute Settlement Understanding; allows enforcement action when: a trade partner under a bilateral or regional trade agreement imposes illegal trade measures,subsequently does not take the steps necessary for the dispute settlement process under that agreement to function; extends the scope of possible countermeasures to trade in services and some trade-related aspects of intellectual property rights. This extension is accompanied by safeguards to ensure that the most efficient and proportionate countermeasures are used and that EU Member States\u2019 authorities and stakeholders are consulted. FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) No 654/2014 has applied since 17 July 2014. Amending Regulation (EU) 2021/167 has applied since 13 February 2021. BACKGROUND For further information, see: Dispute settlement (European Commission). MAIN DOCUMENT Regulation (EU) No 654/2014 of the European Parliament and of the Council of 15 May 2014 concerning the exercise of the Union\u2019s rights for the application and enforcement of international trade rules and amending Council Regulation (EC) No 3286/94 laying down Community procedures in the field of the common commercial policy in order to ensure the exercise of the Community\u2019s rights under international trade rules, in particular those established under the auspices of the World Trade Organization (OJ L 189, 27.6.2014, pp. 50-58) Successive amendments to Regulation (EU) No 654/2014 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) 2018/886 of 20 June 2018 on certain commercial policy measures concerning certain products originating in the United States of America and amending Implementing Regulation (EU) 2018/724 (OJ L 158, 21.6.2018, pp. 5-18) Commission Implementing Regulation (EU) 2018/724 of 16 May 2018 on certain commercial policy measures concerning certain products originating in the United States of America (OJ L 122, 17.5.2018, pp. 14-28) See consolidated version. Report from the Commission to the European Parliament and the Council \u2014 Initial Review of the scope of the Enforcement Regulation (COM(2017) 373 final, 11.7.2017) Regulation (EU) 2015/1843 of the European Parliament and of the Council of 6 October 2015 laying down Union procedures in the field of the common commercial policy in order to ensure the exercise of the Union\u2019s rights under international trade rules, in particular those established under the auspices of the World Trade Organization (codification) (OJ L 272, 16.10.2015, pp. 1-13) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, pp. 1-101) See consolidated version. last update 26.03.2021"}
{"article": "19.1.2013 EN Official Journal of the European Union L 17/13 REGULATION (EU) No 20/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) On 23 April 2007 the Council authorised the Commission to open negotiations with certain countries of Central America (\u2018Central America\u2019) for an Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (\u2018the Agreement\u2019) on behalf of the Union and its Member States. (2) Those negotiations have been concluded and the Agreement was signed on 29 June 2012, received the consent of the European Parliament on 11 December 2012 and is to apply as provided for in Article 353 of the Agreement. (3) It is necessary to lay down the most appropriate procedures to guarantee the effective application of certain provisions of the Agreement which concern the bilateral safeguard clause and for applying the stabilisation mechanism for bananas that has been agreed with Central America. (4) It is also necessary to create appropriate safeguard mechanisms to prevent serious harm to the Union banana growing sector which is of great importance to the agricultural producers of many of the outermost regions of the Union. The limited ability of those regions to diversify, owing to their natural characteristics, makes the banana sector particularly vulnerable. It is therefore essential to create effective mechanisms to address preferential imports from third countries concerned, in order to guarantee that Union banana production is maintained under the best possible conditions, as it is a crucial employment sector in certain areas, especially in the outermost regions. (5) The terms \u2018serious injury\u2019, \u2018threat of serious injury\u2019 and \u2018transition period\u2019 as referred to in Articles 104 and 105 of the Agreement should be defined. (6) Safeguard measures should be considered only if the product in question is imported into the Union in such increased quantities, in absolute terms or relative to Union production, and under such conditions as to cause, or threaten to cause, serious injury to Union producers of like or directly competitive products as laid down in Article 104 of the Agreement. (7) Specific safeguard provisions should be available in case the product in question is imported in such increased quantities and under such conditions as to cause or threaten to cause serious deterioration in the economic situation of any of the outermost regions as referred to in Article 349 of the Treaty on the Functioning of the European Union (TFEU). (8) Safeguard measures should take one of the forms referred to in Article 104(2) of the Agreement. (9) The tasks of following up and reviewing the Agreement, carrying out investigations and, if necessary, imposing safeguard measures should be carried out in the most transparent manner possible. (10) The Commission should submit an annual report to the European Parliament and to the Council on the implementation of the Agreement and the application of the safeguard measures and the stabilisation mechanism for bananas. (11) The challenges in Central America as regards human, social, labour and environmental rights in connection with products from that region require a close dialogue between the Commission and Union civil society organisations. (12) The importance of complying with the international labour standards drawn up and supervised by the International Labour Organisation should be stressed. (13) The Commission should monitor the observance by Central America of the social and environmental standards laid down in Title VIII of Part IV of the Agreement. (14) There should be detailed provisions on the initiation of proceedings. The Commission should receive information including available evidence from the Member States of any trends in imports which might call for the application of safeguard measures. (15) The reliability of statistics on all imports from Central America to the Union is therefore crucial to determining whether the conditions to apply safeguard measures are met. (16) In some cases, an increase of imports concentrated in one or several of the Union's outermost regions or Member States may cause, or threaten to cause, serious deterioration or serious injury in their economic situation. In the event that there is an increase of imports concentrated in one or several of the Union's outermost regions or Member States, the Commission should be able to introduce prior surveillance measures. (17) If there is sufficient prima facie evidence to justify the initiation of a proceeding, the Commission should publish a notice as provided for in Article 111(3) of the Agreement in the Official Journal of the European Union. (18) There should be detailed provisions on the initiation of investigations, access to and inspections by interested parties of the information gathered, hearings for the interested parties involved and the opportunities for those parties to submit their views as provided for in Article 111(3) of the Agreement. (19) The Commission should notify Central America in writing of the initiation of an investigation and notify the results of the investigations to the Association Committee as provided for in Article 116 of the Agreement. (20) It is also necessary, pursuant to Article 112 of the Agreement, to set time limits for the initiation of an investigation and for determinations as to whether or not safeguard measures are appropriate, with a view to ensuring that such determinations are made quickly, in order to increase legal certainty for the economic operators concerned. (21) An investigation should precede the application of any safeguard measure, subject to the Commission being allowed to apply provisional safeguard measures in critical circumstances as referred to in Article 106 of the Agreement. (22) Close monitoring should facilitate a timely decision concerning the possible initiation of an investigation or imposition of measures. Therefore the Commission should regularly monitor imports of bananas from the date of application of the Agreement. Monitoring should be extended to other sectors upon a duly justified request. (23) There should be a possibility to suspend swiftly for a maximum period of three months the preferential customs duties when imports exceed a defined annual trigger import volume. The decision whether or not to apply the stabilisation mechanism for bananas should take into account the stability of the Union market for bananas. (24) Safeguard measures should be applied only to the extent, and for such time, as may be necessary to prevent serious injury and to facilitate adjustment. The maximum duration of safeguard measures should be determined and specific provisions regarding extension and review of such measures should be laid down, as referred to in Article 105 of the Agreement. (25) The Commission should enter into consultations with the Central American country affected by measures. (26) The implementation of the bilateral safeguard clause and the stabilisation mechanism for bananas provided for in the Agreement requires uniform conditions for the adoption of provisional and definitive safeguard measures, for the imposition of prior surveillance measures, for the termination of an investigation without measures and for suspending temporarily the preferential customs duty established under the stabilisation mechanism for bananas that has been agreed with Central America. In order to ensure uniform conditions for the implementation of this Regulation, those measures should be adopted by the Commission in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (2). (27) The advisory procedure should be used for the adoption of surveillance and provisional safeguard measures given the effects of those measures and their sequential logic in relation to the adoption of definitive safeguard measures. Where a delay in the imposition of provisional safeguard measures would cause damage which would be difficult to repair, the Commission should adopt immediately applicable implementing acts. (28) Given the nature and the relatively short duration of the measures foreseen under the stabilisation mechanism for bananas, and in order to prevent a negative impact on the situation of the Union market for bananas, the Commission should also adopt immediately applicable implementing acts for the temporary suspension of the preferential customs duty established under the stabilisation mechanism for bananas, or to determine that such temporary suspension is not appropriate. Where such immediately applicable implementing acts are applied, the advisory procedure should be used. (29) The Commission should make diligent and effective use of the stabilisation mechanism for bananas in order to avoid a threat of serious deterioration or a serious deterioration for producers in the outermost regions in the Union. From 1 January 2020, the general bilateral safeguard mechanism, including the special provisions for outermost regions, remains applicable. (30) For purposes of adopting the necessary implementing rules for the application of the rules contained in Appendix 2A of Annex II (Concerning the definition of the concept of \u2027originating products\u2027 and methods of administrative co-operation) and Appendix 2 of Annex I (Elimination of Customs Duties) to the Agreement, Article 247a of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (3) should be applied. (31) This Regulation should apply only to products originating in the Union or in Central America, HAVE ADOPTED THIS REGULATION: CHAPTER I SAFEGUARD PROVISIONS Article 1 Definitions For the purposes of this Regulation: (a) \u2018product\u2019 means a good originating in the Union or in a Central American country. A product subject to an investigation may cover one or several tariff lines or a sub-segment thereof depending on the specific market circumstances, or any product segmentation commonly applied in the Union industry; (b) \u2018interested parties\u2019 means parties affected by the imports of the product in question; (c) \u2018Union industry\u2019 means the Union producers as a whole of the like or directly competitive products, operating within the territory of the Union, Union producers whose collective output of the like or directly competitive products constitutes a major proportion of the total Union production of those products, or, where a like or a directly competitive product is only one of several products that are made by the Union producers, the specific operations that are involved in the production of the like or directly competitive product; (d) \u2018serious injury\u2019 means a significant overall impairment; (e) \u2018threat of serious injury\u2019 means serious injury that is clearly imminent; (f) \u2018serious deterioration\u2019 means significant disturbances in a sector or in Union industry; (g) \u2018threat of serious deterioration\u2019 means significant disturbances that are clearly imminent; (h) \u2018transitional period\u2019 means ten years from the date of application of the Agreement, for a product for which the Schedule of the EU Party, as set out in Annex I (Elimination of Customs Duties) to the Agreement (\u2018Tariff Elimination Schedule\u2019) provides for a tariff elimination period of less than ten years, or the tariff elimination period plus three years for a product for which the Tariff Elimination Schedule provides for a tariff elimination period of ten or more years; (i) \u2018Central American country\u2019 means Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua or Panama. A determination of the existence of a threat of serious injury within the meaning of point (e) of the first paragraph shall be based on verifiable facts and not merely on an allegation, a conjecture or a remote possibility. In order to determine the existence of a threat of serious injury, forecasts, estimations and analyses made on the basis of factors referred to in Article 5(5), shall, inter alia, be taken into account. Article 2 Principles 1. A safeguard measure may be imposed in accordance with this Regulation where a product originating in a Central American country is, as a result of the reduction or the elimination of the customs duties on that product, imported into the Union in such increased quantities, in absolute terms or relative to Union production, and under such conditions as to cause or threaten to cause serious injury to the Union industry. 2. A safeguard measure may take one of the following forms: (a) a suspension of a further reduction of the rate of customs duty on the product concerned provided for in the Tariff Elimination Schedule; (b) an increase in the rate of customs duty on the product concerned to a level which does not exceed the lesser of: \u2014 the most-favoured-nation (\u2018MFN\u2019) applied rate of customs duty on the product in effect at the time the measure is taken; or \u2014 the MFN applied rate of customs duty on the product in effect on the day immediately preceding the date of entry into force of the Agreement. 3. A safeguard measure shall not be applied within the limits of the preferential duty free tariff quotas granted by the Agreement. Article 3 Monitoring 1. The Commission shall monitor the evolution of import statistics of bananas from Central American countries. For that purpose, it shall cooperate and exchange data on a regular basis with Member States and the Union industry. 2. Upon a duly justified request by the industries concerned, the Commission may consider extending the scope of the monitoring to other sectors. 3. The Commission shall present an annual monitoring report to the European Parliament and to the Council on updated statistics on imports from Central American countries of bananas and those sectors to which monitoring has been extended. 4. The Commission shall monitor the observance by Central American countries of the social and environmental standards laid down in Title VIII of Part IV of the Agreement. Article 4 Initiation of proceedings 1. A proceeding shall be initiated upon request by a Member State, by any legal person or any association not having legal personality acting on behalf of the Union industry, or on the Commission's own initiative if it is apparent to the Commission that there is sufficient prima facie evidence, as determined on the basis of factors referred to in Article 5(5), to justify such initiation. 2. The request to initiate a proceeding shall contain evidence that the conditions for imposing the safeguard measure set out in Article 2(1) are met. The request shall generally contain the following information: the rate and amount of the increase in imports of the product concerned in absolute and relative terms, the share of the domestic market taken by increased imports and changes in the level of sales, production, productivity, capacity utilisation, profits and losses, and employment. 3. A proceeding may also be initiated in the event that there is a surge of imports concentrated in one or several Member States, or outermost regions, provided that there is sufficient prima facie evidence that the conditions for initiation are met, in accordance with Article 5(5). 4. A Member State shall inform the Commission if trends in imports from a Central American country appear to call for safeguard measures. That information shall include the evidence available in accordance with Article 5(5). 5. The Commission shall provide that information to the Member States when it receives a request to initiate a proceeding or when it considers initiation of a proceeding to be appropriate on its own initiative pursuant to paragraph 1. 6. Where it is apparent that there is sufficient prima facie evidence in accordance with Article 5(5) to justify the initiation of a proceeding the Commission shall initiate proceedings and shall publish a notice thereof in the Official Journal of the European Union. Initiation shall take place within one month of receipt by the Commission of the request or information pursuant to paragraph 1. 7. The notice referred to in paragraph 6 shall: (a) give a summary of the information received, and require that all relevant information be communicated to the Commission; (b) state the period within which interested parties may make known their views in writing and submit information, if such views and information are to be taken into account during the proceeding; (c) state the period within which interested parties may apply to be heard orally by the Commission in accordance with Article 5(9). Article 5 Investigations 1. Following the initiation of the proceeding, the Commission shall commence an investigation. The period as set out in paragraph 3 shall start on the day the decision to initiate the investigation is published in the Official Journal of the European Union. 2. The Commission may request Member States to supply information and Member States shall take whatever steps are necessary in order to give effect to any such request. If that information is of general interest and is not confidential within the meaning of Article 12, it shall be added to the non-confidential files as provided for in paragraph 8 of this Article. 3. The investigation shall, where possible, be concluded within six months of its initiation. That time limit may be extended by a further period of three months in exceptional circumstances such as the involvement of an unusually high number of interested parties or complex market situations. The Commission shall notify all interested parties of any such extension and explain the reasons therefor. 4. The Commission shall seek all information it considers necessary to make a determination with regard to the conditions set out in Article 2(1), and, shall, where appropriate, endeavour to verify that information. 5. In the investigation the Commission shall evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of the Union industry, in particular, the rate and amount of the increase in imports of the product concerned in absolute and relative terms, the share of the domestic market taken by increased imports and changes in the level of sales, production, productivity, capacity utilisation, profits and losses, and employment. This list is not exhaustive and other relevant factors may also be taken into consideration by the Commission for its determination of the existence of serious injury or threat of serious injury, such as stocks, prices, return on capital employed, cash flow, and other factors which are causing or may have caused serious injury, or threaten to cause serious injury to the Union industry. 6. Interested parties who have submitted information pursuant to Article 4(7)(b) and representatives of the Central American country concerned may, upon written request, inspect all information made available to the Commission in connection with the investigation other than internal documents prepared by the Union authorities or those of the Member States, provided that that information is relevant to the presentation of their case and not confidential within the meaning of Article 12 and that it is used by the Commission in the investigation. Interested parties who have submitted information may communicate their views on the information to the Commission. Where there is sufficient prima facie evidence in support of those views, the Commission shall take them into consideration. 7. The Commission shall ensure that all data and statistics which are used for the investigation are available, comprehensible, transparent and verifiable. 8. The Commission shall, as soon as the necessary technical framework is in place, ensure password-protected online access to the non-confidential file, which it shall manage and through which all information which is relevant and is not confidential within the meaning of Article 12 shall be disseminated. Interested parties, Member States and the European Parliament shall be granted access to that online platform. 9. The Commission shall hear interested parties, in particular where they have made a written application within the period laid down in the notice published in the Official Journal of the European Union, showing that they are actually likely to be affected by the outcome of the investigation and that there are special reasons for them to be heard orally. The Commission shall hear interested parties on further occasions if there are special reasons therefor. 10. Where information is not supplied within the time limits set by the Commission, or where the investigation is significantly impeded, the Commission may make findings on the basis of the facts available. Where the Commission finds that any interested party or any third party has supplied it with false or misleading information, it shall disregard that information and may make use of the facts available. 11. The Commission shall notify the Central American country concerned in writing of the initiation of an investigation. Article 6 Prior surveillance measures 1. The Commission may adopt prior surveillance measures in regard to imports from a Central American country where: (a) the trend in imports of a product is such that it could lead to one of the situations referred to in Articles 2 and 4; or (b) there is a surge of imports of bananas concentrated in one or several Member States, or in one or several of the Union's outermost regions. 2. The Commission shall adopt prior surveillance measures in accordance with the advisory procedure referred to in Article 14(2). 3. Prior surveillance measures shall have a limited period of validity. Unless otherwise provided, they shall cease to be valid at the end of the second six-month period following the first six months after their introduction. Article 7 Imposition of provisional safeguard measures 1. Provisional safeguard measures shall be applied in critical circumstances where a delay would cause damage which would be difficult to repair, pursuant to a preliminary determination on the basis of the factors referred to in Article 5(5) that there is sufficient prima facie evidence that imports of a product originating in a Central American country have increased as a result of the reduction or elimination of a customs duty in accordance with the Tariff Elimination Schedule, and such imports cause serious injury, or threat thereof, to the Union industry. The Commission shall adopt provisional safeguard measures in accordance with the advisory procedure referred to in Article 14(2). In cases of imperative grounds of urgency, including the case referred to in paragraph 2 of this Article, the Commission shall adopt immediately applicable provisional safeguard measures in accordance with the procedure referred to in Article 14(4). 2. Where a Member State requests immediate intervention by the Commission and where the conditions set out in paragraph 1 are met, the Commission shall take a decision within five working days of receiving the request. 3. Provisional safeguard measures shall not apply for more than 200 calendar days. 4. Should the provisional safeguard measures be repealed because the investigation shows that the conditions set out in Article 2(1) are not met, any customs duty collected as a result of those provisional safeguard measures shall be refunded automatically. 5. Provisional safeguard measures shall apply to every product which is put into free circulation after the date of entry into force of those measures. However, such measures shall not prevent the release for free circulation of products already on their way to the Union where the destination of such products cannot be changed. Article 8 Termination of investigations and proceedings without measures 1. Where the facts as finally established show that the conditions set out in Article 2(1) are not met, the Commission shall adopt a decision terminating the investigation and proceeding in accordance with the examination procedure referred to in Article 14(3). 2. The Commission shall make public, with due regard to the protection of confidential information within the meaning of Article 12, a report setting out its findings and reasoned conclusions reached on all pertinent issues of fact and law. Article 9 Imposition of definitive safeguard measures 1. Where the facts as finally established show that the conditions set out in Article 2(1) are met, the Commission shall refer the matter to the Association Committee for examination in accordance with Article 116 of the Agreement. Where no recommendation has been made by the Association Committee or no other satisfactory solution has been reached within 30 days of the referral, the Commission may adopt a decision imposing definitive safeguard measures in accordance with the examination procedure referred to in Article 14(3). 2. The Commission shall make public, with due regard to the protection of confidential information within the meaning of Article 12, a report containing a summary of the material facts and considerations relevant to the determination. Article 10 Duration and review of safeguard measures 1. A safeguard measure shall remain in force only for such period of time as may be necessary to prevent or remedy the serious injury to Union industry and to facilitate adjustment. That period shall not exceed two years, unless it is extended under paragraph 3. 2. A safeguard measure shall remain in force, pending the outcome of the review under paragraph 3, during any extension period. 3. The initial period of duration of a safeguard measure may exceptionally be extended by up to two years provided that the safeguard measure continues to be necessary to prevent or remedy serious injury to Union industry and that there is evidence that the Union industry is adjusting. 4. Any extension pursuant to paragraph 3 of this Article shall be preceded by an investigation upon a request by a Member State, by any legal person or any association not having legal personality acting on behalf of the Union industry, or on the Commission's own initiative if there is sufficient prima facie evidence that the conditions laid down in paragraph 3 of this Article are met, on the basis of factors referred to in Article 5(5). 5. The initiation of an investigation shall be published in accordance with Article 4(6) and (7). The investigation and any decision regarding an extension pursuant to paragraph 3 of this Article shall be made in accordance with Articles 5, 8 and 9. 6. The total duration of a safeguard measure shall not exceed four years, including any provisional safeguard measure. 7. A safeguard measure shall not be applied beyond the expiry of the transitional period, except with the consent of the Central American country concerned. 8. No safeguard measure shall be applied to the import of a product that has previously been subject to such a measure, unless a period of time equal to half of that during which the safeguard measure was applied for the immediately preceding period has elapsed. Article 11 Outermost regions of the Union Where any product originating in a Central American country is being imported in such increased quantities and under such conditions as to cause or threaten to cause serious deterioration in the economic situation of one or several of the Union's outermost regions, as referred to in Article 349 TFEU, a safeguard measure may be imposed, in accordance with this Chapter. Article 12 Confidentiality 1. Information received pursuant to this Regulation shall be used only for the purpose for which it was requested. 2. Neither information of a confidential nature nor any information provided on a confidential basis received pursuant to this Regulation shall be disclosed without the express consent of the supplier of such information. 3. Each request for confidentiality shall state the reasons why the information is confidential. However, if the supplier of the information requests that the information is not made public or disclosed, in full or in summary form, and if that request is unjustified, the information concerned may be disregarded. 4. Information shall in any case be considered to be confidential if its disclosure is likely to have a significantly adverse effect upon the supplier or the source of such information. 5. Paragraphs 1 to 4 shall not preclude reference by the Union authorities to general information and in particular to reasons on which decisions taken pursuant to this Regulation are based. Those authorities shall, however, take into account the legitimate interest of natural and legal persons concerned that their business secrets should not be divulged. Article 13 Report 1. The Commission shall submit an annual report to the European Parliament and to the Council on the application, implementation and fulfilment of obligations of Part IV of the Agreement and of this Regulation. 2. The report shall include information about the application of provisional and definitive measures, prior surveillance measures, regional surveillance and safeguard measures and the termination of investigations and proceedings without measures. 3. The report shall include information on the activities of the various bodies responsible for monitoring the implementation of the Agreement, including on fulfilment of obligations under Title VIII of Part IV of the Agreement and on activities with civil society advisory groups. 4. The report shall set out a summary of the statistics and the evolution of trade with Central American countries and shall include up-to-date statistics on banana imports from Central American countries. 5. The European Parliament may, within one month of submission of the Commission's report, invite the Commission to an ad hoc meeting of its responsible committee to present and explain any issues related to the implementation of this Regulation. 6. No later than three months after submitting its report to the European Parliament and to the Council, the Commission shall make it public. Article 14 Committee procedure 1. The Commission shall be assisted by the Committee established by Article 4(1) of Council Regulation (EC) No 260/2009 of 26 February 2009 on the common rules for imports (4) (\u2018the Committee\u2019). The Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 thereof, shall apply. 5. The Committee may examine matters relating to the application of this Regulation, raised by the Commission or at the request of a Member State. Member States may request information and may exchange views in the Committee or directly with the Commission. CHAPTER II STABILISATION MECHANISM FOR BANANAS Article 15 Stabilisation mechanism for bananas 1. For bananas originating in Central America falling under heading 0803 00 19 of the Combined Nomenclature (fresh Bananas, excluding plantains) and listed under category \u2018ST\u2019 in the Tariff Elimination Schedule, a stabilisation mechanism shall apply until 31 December 2019. 2. A separate annual trigger import volume is set for imports of products referred to in paragraph 1, as indicated in the table in the Annex. The importation of the products referred to in paragraph 1 at the preferential customs duty rate shall, in addition to the proof of origin established under Annex II (Concerning the definition of the concept of \u2018originating products\u2019 and methods of administrative co-operation) to the Agreement, be subject to the presentation of an export certificate issued by the competent authority of the Republic of the Central American country from which the products are exported. Once the trigger volume for a Central American country is met during the corresponding calendar year, the Commission shall, in accordance with the urgency procedure referred to in Article 14(4), adopt an implementing act by which it may either temporarily suspend the preferential customs duty applied to products of the corresponding origin during that same year for a period of time not exceeding three months, and not going beyond the end of the calendar year or determine that such suspension is not appropriate. 3. When deciding whether measures should be applied pursuant to paragraph 2, the Commission shall take into consideration the impact of the imports concerned on the situation of the Union market for bananas. That examination shall include factors such as: effect of the imports concerned on the Union price level, development of imports from other sources, overall stability of the Union market. 4. Where the Commission decides to suspend the preferential customs duty applicable, it shall apply the lesser of the base rate of customs duty or the MFN rate of duty that in application at the time such action is taken. 5. Where the Commission applies the actions referred to in paragraphs 2 and 4, it shall immediately enter into consultations with the affected Central American country or countries to analyse and evaluate the situation on the basis of available factual data. 6. The application of the stabilisation mechanism for bananas set out in this Chapter is without prejudice to the application of any measures defined in Chapter I. Measures taken pursuant to the provisions of both chapters shall not, however, be applied simultaneously. 7. The measures referred to in paragraphs 2 and 4 shall be applicable only during the period ending on 31 December 2019. CHAPTER III IMPLEMENTING RULES Article 16 Implementing rules The applicable provision for the purposes of adopting the necessary implementing rules for the application of the rules contained in Appendix 2A of Annex II (Concerning the definition of the concept of \u2018originating products\u2019 and methods of administrative co-operation) and Appendix 2 of Annex I (Elimination of Customs Duties) to the Agreement shall be Article 247a of Regulation (EEC) No 2913/92. CHAPTER IV FINAL PROVISIONS Article 17 Entry into force This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. It shall apply from the date of application of the Agreement as provided for in Article 353 thereof. A notice shall be published in the Official Journal of the European Union specifying the date of application of the Agreement. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 January 2013. For the European Parliament The President M. SCHULZ For the Council The President L. CREIGHTON (1) Position of the European Parliament of 11 December 2012 (not yet published in the Official Journal) and decision of the Council of 20 December 2012. (2) OJ L 55, 28.2.2011, p. 13. (3) OJ L 302, 19.10.1992, p. 1. (4) OJ L 84, 31.3.2009, p. 1. ANNEX Table regarding trigger import volumes for the application of the stabilisation mechanism for bananas provided for in Appendix 3 of Annex I to the Agreement Year Trigger import volume, in tonnes Costa Rica Panama Honduras Guatemala Nicaragua El Salvador Until 31 December 2010 1 025 000 375 000 50 000 50 000 10 000 2 000 1.1-31.12.2011 1 076 250 393 750 52 500 52 500 10 500 2 100 1.1-31.12.2012 1 127 500 412 500 55 000 55 000 11 000 2 200 1.1-31.12.2013 1 178 750 431 250 57 500 57 500 11 500 2 300 1.1-31.12.2014 1 230 000 450 000 60 000 60 000 12 000 2 400 1.1-31.12.2015 1 281 250 468 750 62 500 62 500 12 500 2 500 1.1-31.12.2016 1 332 500 487 500 65 000 65 000 13 000 2 600 1.1-31.12.2017 1 383 750 506 250 67 500 67 500 13 500 2 700 1.1-31.12.2018 1 435 000 525 000 70 000 70 000 14 000 2 800 1.1-31.12.2019 1 486 250 543 750 72 500 72 500 14 500 2 900 1.1.2020 and after not applicable not applicable not applicable not applicable not applicable not applicable COMMISSION STATEMENT The Commission welcomes the first reading agreement between the European Parliament and the Council on Regulation (EU) No 20/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (1). As envisaged in Regulation (EU) No 20/2013, the Commission will submit an annual report to the European Parliament and to the Council on the implementation of Part IV of the Agreement and will be ready to discuss with the responsible committee of the European Parliament any issues arising from the implementation of Part IV of the Agreement. The Commission will attach particular importance to the effective implementation of commitments on trade and sustainable development in the Agreement, taking into account the specific information provided by the relevant monitoring bodies of the fundamental Conventions of the International Labour Organisation and the multilateral environmental agreements listed in Title VIII of Part IV of the Agreement. In this context, the Commission will also seek the views of the relevant civil society advisory groups. After the expiry of the Banana Stabilisation Mechanism on 31 December 2019, the Commission will assess the situation of the Union market for bananas and the state of Union banana producers. The Commission will report its findings to the European Parliament and the Council and would include a preliminary assessment of the functioning of the \u2018Programme d'Options Sp\u00e9cifiques \u00e0 l'\u00c9loignement et l'Insularit\u00e9\u2019 (POSEI) in preserving the banana production in the Union. (1) See page 13 of this Official Journal. JOINT DECLARATION The European Parliament and the Commission agree on the importance of close cooperation in monitoring the implementation of Part IV of the Agreement and Regulation (EU) No 20/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (1). To that end they agree on the following: \u2014 Upon request by the responsible committee of the European Parliament, the Commission shall report to it on any specific concerns relating to the implementation by Central American countries of their commitments on trade and sustainable development. \u2014 If the European Parliament adopts a recommendation to initiate a safeguard investigation, the Commission will carefully examine whether the conditions under Regulation (EU) No 20/2013 for ex-officio initiation are fulfilled. If the Commission considers that the conditions are not fulfilled, it will present a report to the responsible committee of the European Parliament including an explanation of all the factors relevant to the initiation of such an investigation. (1) See page 13 of this Official Journal.", "summary": "Association Agreement between the EU and Central America Association Agreement between the EU and Central America SUMMARY OF: Agreement establishing an Association between the EU and Central America Decision 2012/734/EU \u2014 signing, on behalf of the EU, the Agreement establishing an Association between the EU and Central America Decision No 5/2014 of the EU-Central America Association Council \u2014 on the geographical indications to be included in Annex XVIII of the Agreement Regulation (EU) No 20/2013 \u2014 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the EU and Central America WHAT IS THE AIM OF THE AGREEMENT, DECISIONS AND REGULATION? The aims of the agreement include to: strengthen and consolidate the relations between the parties through an association based on three interdependent and fundamental parts; develop a privileged political partnership based on values, principles and common objectives, in particular the respect for and the promotion of democracy and human rights, sustainable development, good governance and the rule of law; enhance bi-regional cooperation between the EU and Central America in all areas of common interest; expand and diversify the parties\u2019 bi-regional trade relation in conformity with the World Trade Organisation (WTO) agreement and this agreement; strengthen and deepen regional integration in areas of common interest; reinforce good neighbourly relations and the principle of peaceful resolution of disputes; maintain and develop the level of good governance, social, labour and environmental standards; foster increased trade and investment among the parties. The Council decision concludes the agreement on behalf of the EU. Decision No 5/2014 establishes the geographical indications of products originating from the 2 parties. The regulation creates safeguard mechanisms to prevent serious harm to the EU banana-growing sector in the EU\u2019s outermost regions. KEY POINTS The agreement consists of three strands: 1. Political dialogue The objectives of the political dialogue between the 2 parties are to: establish a privileged political partnership; defend common values, principles and objectives by promoting them at international level, in particular at the United Nations (UN); strengthen the UN as the core of the multilateral system, in order to enable it to tackle global challenges effectively; enable a broad exchange of views, positions and information leading to joint initiatives at international level; cooperate in the field of foreign and security policy, with the objective of coordinating their positions and taking joint initiatives of mutual interest in the relevant international forums. Such dialogue can cover all aspects of mutual interest at international or regional level, however, a number of specific issues are mentioned including: disarmament; the fight against terrorism; migration; the environment. 2. Cooperation The agreement gives priority to cooperation aimed at achieving the following objectives: strengthening peace and security; reinforcing democratic institutions, good governance and full applicability of the rule of law, gender equality, all forms of non-discrimination, cultural diversity, pluralism, promotion and respect for human rights, fundamental freedoms, transparency and citizen participation; contributing to social cohesion; promoting economic growth with a view to furthering sustainable development; deepening the process of regional integration in Central America; reinforcing production and management capacities and enhancing competitiveness. 3. Trade The objectives of this strand include: expanding and diversifying trade in goods; facilitating trade in goods; liberalising trade in services, in conformity with Article V of the General Agreement on Trade in Services (GATS); promoting economic regional integration in the area of customs procedures, technical regulations and sanitary and phytosanitary measures; developing a climate conducive to increased investment; the effective, reciprocal and gradual opening of government procurement markets; adequately and effectively protecting intellectual property rights; promoting free and undistorted competition in the economic and trade relations; establishing an effective, fair and predictable dispute-settlement mechanism; promoting international trade and investment between the parties. The agreement includes a number of measures to achieve these objectives, in particular it: provides substantially improved market access for EU exports to Central America through: eliminating tariffs on manufactured goods, fisheries and agriculture;addressing obstacles to trade in goods;improving market access to government procurement, services and investment; establishes a level playing field through common rules in areas such as: intellectual property and geographical indications;competition and state aid;dispute settlement; reinforces regional integration by introducing measures such as: a single administrative document for customs declarations;a single import duty for the region; sets out an agreement for sustainable development designed to: further economic development through trade;address the interrelation between trade and social and environmental policies;encourage and promote trade and marketing schemes based on sustainability criteria. WHEN DID THE AGREEMENT, DECISIONS AND REGULATION ENTER INTO FORCE? The trade part of the agreement has provisionally applied since: 1 August 2013 with Honduras, Nicaragua and Panama;1 October 2013 with Costa Rica and El Salvador; and1 December 2013 with Guatemala. The Council decision entered into force on 25 June 2012, the regulation on 22 January 2013 and Decision No 5/2014 on 5 August 2015. BACKGROUND For more information, see: Central America (European Commission). MAIN DOCUMENTS Council Decision 2012/734/EU of 25 June 2012 on the signing, on behalf of the European Union, of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other, and the provisional application of Part IV thereof concerning trade matters (OJ L 346, 15.12.2012, pp. 1-2) Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (OJ L 346, 15.12.2012, pp. 3-2621) Decision No 5/2014 of the EU-Central America Association Council of 7 November 2014 on the geographical indications to be included in Annex XVIII of the Agreement [2015/1219] (OJ L 196, 24.7.2015, pp. 59-66) Regulation (EU) No 20/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (OJ L 17, 19.1.2013, pp. 13-24) Successive amendments to Regulation (EU) No 20/2013 have been incorporated into the original act. This consolidated version is of documentary value only. RELATED DOCUMENTS Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Guatemala) (OJ L 315, 26.11.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Costa Rica) (OJ L 257, 28.9.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (El Salvador) (OJ L 257, 28.9.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Nicaragua) (OJ L 204, 31.7.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Panama) (OJ L 204, 31.7.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Honduras) (OJ L 204, 31.7.2013, p. 1) last update 02.10.2019"}
{"article": "27.6.2014 EN Official Journal of the European Union L 189/59 REGULATION (EU) No 655/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 establishing a European Account Preservation Order procedure to facilitate cross-border debt recovery in civil and commercial matters THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular points (a), (e) and (f) of Article 81(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Union has set itself the objective of maintaining and developing an area of freedom, security and justice in which the free movement of persons is ensured. For the gradual establishment of such an area, the Union is to adopt measures relating to judicial cooperation in civil matters having cross-border implications, particularly when necessary for the proper functioning of the internal market. (2) In accordance with Article 81(2) of the Treaty on the Functioning of the European Union (TFEU), such measures may include measures aimed at ensuring, inter alia, the mutual recognition and enforcement of judgments between Member States, effective access to justice and the elimination of obstacles to the proper functioning of civil proceedings, if necessary by promoting the compatibility of the rules on civil procedure applicable in the Member States. (3) On 24 October 2006, by way of the \u2018Green Paper on improving the efficiency of the enforcement of judgments in the European Union: the attachment of bank accounts\u2019, the Commission launched a consultation on the need for a uniform European procedure for the preservation of bank accounts and the possible features of such a procedure. (4) In the Stockholm Programme of December 2009 (3), which sets freedom, security and justice priorities for 2010 to 2014, the European Council invited the Commission to assess the need for, and the feasibility of, providing for certain provisional, including protective, measures at Union level, to prevent for example the disappearance of assets before the enforcement of a claim, and to put forward appropriate proposals for improving the efficiency of enforcement of judgments in the Union regarding bank accounts and debtors\u2019 assets. (5) National procedures for obtaining protective measures such as account preservation orders exist in all Member States, but the conditions for the grant of such measures and the efficiency of their implementation vary considerably. Moreover, recourse to national protective measures may prove cumbersome in cases having cross-border implications, in particular when the creditor seeks to preserve several accounts located in different Member States. It therefore seems necessary and appropriate to adopt a binding and directly applicable legal instrument of the Union which establishes a new Union procedure allowing, in cross-border cases, for the preservation, in an efficient and speedy way, of funds held in bank accounts. (6) The procedure established by this Regulation should serve as an additional and optional means for the creditor, who remains free to make use of any other procedure for obtaining an equivalent measure under national law. (7) A creditor should be able to obtain a protective measure in the form of a European Account Preservation Order (\u2018Preservation Order\u2019 or \u2018Order\u2019) preventing the transfer or withdrawal of funds held by his debtor in a bank account maintained in a Member State if there is a risk that, without such a measure, the subsequent enforcement of his claim against the debtor will be impeded or made substantially more difficult. The preservation of funds held in the debtor\u2019s account should have the effect of preventing not only the debtor himself, but also persons authorised by him to make payments through that account, for example by way of a standing order or through direct debit or the use of a credit card, from using the funds. (8) The scope of this Regulation should cover all civil and commercial matters apart from certain well-defined matters. In particular, this Regulation should not apply to claims against a debtor in insolvency proceedings. This should mean that no Preservation Order can be issued against the debtor once insolvency proceedings as defined in Council Regulation (EC) No 1346/2000 (4) have been opened in relation to him. On the other hand, the exclusion should allow the Preservation Order to be used to secure the recovery of detrimental payments made by such a debtor to third parties. (9) This Regulation should apply to accounts held with credit institutions whose business is to take deposits or other repayable funds from the public and to grant credits for their own account. It should thus not apply to financial institutions which do not take such deposits, for instance institutions providing financing for export and investment projects or projects in developing countries or institutions providing financial market services. Furthermore, this Regulation should not apply to accounts held by or with central banks when acting in their capacity as monetary authorities, nor to accounts that cannot be preserved by national orders equivalent to a Preservation Order or which are otherwise immune from seizure under the law of the Member State where the account in question is maintained. (10) This Regulation should apply to cross-border cases only and should define what constitutes a cross-border case in this particular context. For the purposes of this Regulation, a cross-border case should be considered to exist when the court dealing with the application for the Preservation Order is located in one Member State and the bank account concerned by the Order is maintained in another Member State. A cross-border case should also be considered to exist when the creditor is domiciled in one Member State and the court and the bank account to be preserved are located in another Member State. This Regulation should not apply to the preservation of accounts maintained in the Member State of the court seized of the application for the Preservation Order if the creditor\u2019s domicile is also in that Member State, even if the creditor applies at the same time for a Preservation Order which concerns an account or accounts maintained in another Member State. In such a case, the creditor should make two separate applications, one for a Preservation Order and one for a national measure. (11) The procedure for a Preservation Order should be available to a creditor wishing to secure the enforcement of a later judgment on the substance of the matter prior to initiating proceedings on the substance of the matter and at any stage during such proceedings. It should also be available to a creditor who has already obtained a judgment, court settlement or authentic instrument requiring the debtor to pay the creditor\u2019s claim. (12) The Preservation Order should be available for the purpose of securing claims that have already fallen due. It should also be available for claims that are not yet due as long as such claims arise from a transaction or an event that has already occurred and their amount can be determined, including claims relating to tort, delict or quasi-delict and civil claims for damages or restitution which are based on an act giving rise to criminal proceedings. A creditor should be able to request that the Preservation Order be issued in the amount of the principal claim or in a lower amount. The latter may be in his interest, for instance, where he has already obtained some other security for part of his claim. (13) In order to ensure a close link between the proceedings for the Preservation Order and the proceedings on the substance of the matter, international jurisdiction to issue the Order should lie with the courts of the Member State whose courts have jurisdiction to rule on the substance of the matter. For the purposes of this Regulation, the notion of proceedings on the substance of the matter should cover any proceedings aimed at obtaining an enforceable title on the underlying claim including, for instance, summary proceedings concerning orders to pay and proceedings such as the French \u2018proc\u00e9dure de r\u00e9f\u00e9r\u00e9\u2019. If the debtor is a consumer domiciled in a Member State, jurisdiction to issue the Order should lie only with the courts of that Member State. (14) The conditions for issuing the Preservation Order should strike an appropriate balance between the interest of the creditor in obtaining an Order and the interest of the debtor in preventing abuse of the Order. Consequently, when the creditor applies for a Preservation Order prior to obtaining a judgment, the court with which the application is lodged should have to be satisfied on the basis of the evidence submitted by the creditor that the creditor is likely to succeed on the substance of his claim against the debtor. Furthermore, the creditor should be required in all situations, including when he has already obtained a judgment, to demonstrate to the satisfaction of the court that his claim is in urgent need of judicial protection and that, without the Order, the enforcement of the existing or a future judgment may be impeded or made substantially more difficult because there is a real risk that, by the time the creditor is able to have the existing or a future judgment enforced, the debtor may have dissipated, concealed or destroyed his assets or have disposed of them under value, to an unusual extent or through unusual action. The court should assess the evidence submitted by the creditor to support the existence of such a risk. This could relate, for instance, to the debtor\u2019s conduct in respect of the creditor\u2019s claim or in a previous dispute between the parties, to the debtor\u2019s credit history, to the nature of the debtor\u2019s assets and to any recent action taken by the debtor with regard to his assets. In assessing the evidence, the court may consider that withdrawals from accounts and instances of expenditure by the debtor to sustain the normal course of his business or recurrent family expenses are not, in themselves, unusual. The mere non-payment or contesting of the claim or the mere fact that the debtor has more than one creditor should not, in themselves, be considered sufficient evidence to justify the issuing of an Order. Nor should the mere fact that the financial circumstances of the debtor are poor or deteriorating, in itself, constitute a sufficient ground for the issuing of an Order. However, the court may take these factors into account in the overall assessment of the existence of the risk. (15) In order to ensure the surprise effect of the Preservation Order, and to ensure that it will be a useful tool for a creditor trying to recover debts from a debtor in cross-border cases, the debtor should not be informed about the creditor\u2019s application nor be heard prior to the issue of the Order or notified of the Order prior to its implementation. Where, on the basis of the evidence and information provided by the creditor or, if applicable, by his witness(es), the court is not satisfied that the preservation of the account or accounts in question is justified, it should not issue the Order. (16) In situations where the creditor applies for a Preservation Order before initiating proceedings on the substance of the matter before a court, this Regulation should oblige him to initiate such proceedings within a specified period of time and should also oblige him to provide proof of such initiation to the court with which he lodged his application for an Order. Should the creditor fail to comply with this obligation, the Order should be revoked by the court of its own motion or should terminate automatically. (17) In view of the absence of a prior hearing of the debtor, this Regulation should provide for specific safeguards in order to prevent abuse of the Order and to protect the debtor\u2019s rights. (18) One such important safeguard should be the possibility of requiring the creditor to provide security so as to ensure that the debtor can be compensated at a later stage for any damage caused to him by the Preservation Order. Depending on national law, such security could be provided in the form of a security deposit or an alternative assurance, such as a bank guarantee or a mortgage. The court should have discretion in determining the amount of security sufficient to prevent abuse of the Order and to ensure compensation to the debtor and it should be open to the court, in the absence of specific evidence as to the amount of the potential damage, to consider the amount in which the Order is to be issued as a guideline for determining the amount of the security. In cases where the creditor has not yet obtained a judgment, court settlement or authentic instrument requiring the debtor to pay the creditor\u2019s claim, the provision of security should be the rule and the court should dispense with this requirement, or require the provision of security in a lower amount, only exceptionally if it considers that such security is inappropriate, superfluous or disproportionate in the circumstances of the case. Such circumstances could be, for instance, that the creditor has a particularly strong case but does not have sufficient means to provide security, that the claim relates to maintenance or to the payment of wages or that the size of the claim is such that the Order is unlikely to cause any damage to the debtor, for instance a small business debt. In cases where the creditor has already obtained a judgment, court settlement or authentic instrument, the provision of security should be left to the discretion of the court. The provision of security may, for instance, be appropriate, except in the abovementioned exceptional circumstances, where the judgment the enforcement of which the Preservation Order intends to secure is not yet enforceable or only provisionally enforceable due to a pending appeal. (19) Another important element for striking an appropriate balance between the creditor\u2019s and the debtor\u2019s interests should be a rule on the creditor\u2019s liability for any damage caused to the debtor by the Preservation Order. This Regulation should therefore, as a minimum standard, provide for the liability of the creditor where the damage caused to the debtor by the Preservation Order is due to fault on the creditor\u2019s part. In this context, the burden of proof should lie with the debtor. As regards the grounds for liability specified in this Regulation, provision should be made for a harmonised rule establishing a rebuttable presumption of fault on the part of the creditor. Furthermore, the Member States should be able to maintain or introduce in their national law grounds for liability other than those specified in this Regulation. For such other grounds of liability, the Member States should also be able to maintain or introduce other types of liability, such as strict liability. This Regulation should also lay down a conflict-of-laws rule specifying that the law applicable to the creditor\u2019s liability should be the law of the Member State of enforcement. Where there are several Member States of enforcement, the law applicable should be the law of the Member State of enforcement in which the debtor is habitually resident. In a case in which the debtor is not habitually resident in any of the Member States of enforcement, the law applicable should be the law of the Member State of enforcement with which the case has the closest connection. In determining the closest connection, the size of the amount preserved in the different Member States of enforcement could be one of the factors to be taken into account by the court. (20) In order to overcome existing practical difficulties in obtaining information about the whereabouts of the debtor\u2019s bank account in a cross-border context, this Regulation should set out a mechanism allowing the creditor to request that the information needed to identify the debtor\u2019s account be obtained by the court, before a Preservation Order is issued, from the designated information authority of the Member State in which the creditor believes that the debtor holds an account. Given the particular nature of such an intervention by public authorities and of such access to private data, access to account information should, as a rule, be given only in cases where the creditor has already obtained an enforceable judgment, court settlement or authentic instrument. However, by way of exception, it should be possible for the creditor to make a request for account information even though his judgment, court settlement or authentic instrument is not yet enforceable. Such a request should be possible where the amount to be preserved is substantial taking into account the relevant circumstances and the court is satisfied, on the basis of the evidence submitted by the creditor, that there is an urgent need for such account information because there is a risk that, without it, the subsequent enforcement of the creditor\u2019s claim against the debtor is likely to be jeopardised and that this could consequently lead to a substantial deterioration of the creditor\u2019s financial situation. To allow that mechanism to work, the Member States should make available in their national law one or more methods for obtaining such information which are effective and efficient and which are not disproportionately costly or time-consuming. The mechanism should apply only if all the conditions and requirements for issuing the Preservation Order are met and the creditor has duly substantiated in his request why there are reasons to believe that the debtor holds one or more accounts in a specific Member State, for instance because the debtor works or exercises a professional activity in that Member State or has property there. (21) In order to ensure protection of the personal data of the debtor, the information obtained regarding the identification of the debtor\u2019s bank account or accounts should not be provided to the creditor. It should be provided only to the requesting court and, exceptionally, to the debtor\u2019s bank if the bank or other entity responsible for enforcing the Order in the Member State of enforcement is not able to identify an account of the debtor on the basis of the information provided in the Order, for instance where there are accounts held with the same bank by several persons having the same name and the same address. Where, in such a case, it is indicated in the Order that the number or numbers of the account(s) to be preserved was or were obtained through a request for information, the bank should request that information from the information authority of the Member State of enforcement and should be able to make such a request in an informal and simple manner. (22) This Regulation should grant the creditor the right to appeal against a refusal to issue the Preservation Order. That right should be without prejudice to the possibility for the creditor to make a new application for a Preservation Order on the basis of new facts or new evidence. (23) Enforcement structures for preserving bank accounts vary considerably in the Member States. In order to avoid duplication of those structures in the Member States and to respect national procedures to the extent possible, this Regulation should, as regards the enforcement and actual implementation of the Preservation Order, build on the methods and structures in place for the enforcement and implementation of equivalent national orders in the Member State in which the Order is to be enforced. (24) In order to ensure swift enforcement, this Regulation should provide for transmission of the Order from the Member State of origin to the competent authority of the Member State of enforcement by any appropriate means which ensure that the content of the documents transmitted is true and faithful and easily legible. (25) Upon receiving the Preservation Order, the competent authority of the Member State of enforcement should take the necessary steps to have the Order enforced in accordance with its national law, either by transmitting the Order received to the bank or other entity responsible for enforcing such orders in that Member State or, where national law so provides, by otherwise instructing the bank to implement the Order. (26) Depending on the method available under the law of the Member State of enforcement for equivalent national orders, the Preservation Order should be implemented by blocking the preserved amount in the debtor\u2019s account or, where national law so provides, by transferring that amount to an account dedicated for preservation purposes, which could be an account held by either the competent enforcement authority, the court, the bank with which the debtor holds his account or a bank designated as coordinating entity for the preservation in a given case. (27) This Regulation should not prevent the payment of fees for the enforcement of the Preservation Order from being requested in advance. This issue should be left to the national law of the Member State in which the Order is to be enforced. (28) A Preservation Order should have the same rank, if any, as an equivalent national order in the Member State of enforcement. If, under national law, certain enforcement measures have priority over preservation measures, the same priority should be given to them in relation to Preservation Orders under this Regulation. For the purposes of this Regulation, the in personam orders which exist in some national legal systems should be considered to be equivalent national orders. (29) This Regulation should provide for the imposition on the bank or other entity responsible for enforcing the Preservation Order in the Member State of enforcement of an obligation to declare whether and, if so, to what extent the Order has led to the preservation of any funds of the debtor, and of an obligation on the creditor to ensure the release of any funds preserved that exceed the amount specified in the Order. (30) This Regulation should safeguard the debtor\u2019s right to a fair trial and his right to an effective remedy and should therefore, having regard to the ex parte nature of the proceedings for the issue of the Preservation Order, enable him to contest the Order or its enforcement on the grounds provided for in this Regulation immediately after the implementation of the Order. (31) In this context, this Regulation should require that the Preservation Order, all documents submitted by the creditor to the court in the Member State of origin and the necessary translations be served on the debtor promptly after the implementation of the Order. The court should have discretionary powers to append any further documents on which it based its decision and which the debtor might need for his remedy action, such as verbatim transcripts of any oral hearing. (32) The debtor should be able to request a review of the Preservation Order, in particular if the conditions or requirements set out in this Regulation were not met or if the circumstances that led to the issuing of the Order have changed in such a way that the issuing of the Order would no longer be founded. For instance, a remedy should be available to the debtor if the case did not constitute a cross-border case as defined in this Regulation, if the jurisdiction rules set out in this Regulation were not respected, if the creditor did not initiate proceedings on the substance of the matter within the period of time provided for in this Regulation and the court did not, as a consequence, revoke the Order of its own motion or the Order did not terminate automatically, if the creditor\u2019s claim was not in need of urgent protection in the form of a Preservation Order because there was no risk that the subsequent enforcement of that claim would be impeded or made substantially more difficult, or if the provision of security was not in conformity with the requirements set out in this Regulation. A remedy should also be available to the debtor if the Order and the declaration on the preservation have not been served on him as provided for in this Regulation or if the documents served on him did not meet the language requirements provided for in this Regulation. However, such a remedy should not be granted if the lack of service or translation is cured within a given period of time. In order to cure the lack of service, the creditor should make a request to the body responsible for service in the Member State of origin to have the relevant documents served by registered post on the debtor or, where the debtor has agreed to collect the documents at the court, should provide the necessary translations of the documents to the court. Such a request should not be required if the lack of service has already been cured by other means, for instance if, in accordance with national law, the court initiated the service of its own motion. (33) The question as to who has to provide any translations required under this Regulation and who has to bear the costs for such translations is left to national law. (34) Jurisdiction to grant the remedies against the issue of the Preservation Order should lie with the courts of the Member State in which the Order was issued. Jurisdiction to grant the remedies against the enforcement of the Order should lie with the courts or, where applicable, with the competent enforcement authorities in the Member State of enforcement. (35) The debtor should have the right to apply for the release of the preserved funds if he provides appropriate alternative security. Such alternative security could be provided in the form of a security deposit or an alternative assurance, such as a bank guarantee or a mortgage. (36) This Regulation should ensure that the preservation of the debtor\u2019s account does not affect amounts which are exempt from seizure under the law of the Member State of enforcement, for example amounts necessary to ensure the livelihood of the debtor and his family. Depending on the procedural system applicable in that Member State, the relevant amount should either be exempted ex officio by the body responsible, which could be the court, the bank or the competent enforcement authority, before the Order is implemented, or be exempted at the request of the debtor after the implementation of the Order. Where accounts in several Member States are preserved and the exemption has been applied more than once, the creditor should be able to apply to the competent court of any of the Member States of enforcement or, where the national law of the Member State of enforcement concerned so provides, to the competent enforcement authority in that Member State, for an adjustment of the exemption applied in that Member State. (37) In order to ensure that the Preservation Order is issued and enforced swiftly and without delay, this Regulation should establish time-limits by which the different steps in the procedure must be completed. Courts or authorities involved in the procedure should only be allowed to derogate from those time-limits in exceptional circumstances, for instance in cases which are legally or factually complex. (38) For the purposes of calculating the periods and time-limits provided for in this Regulation, Regulation (EEC, Euratom) No 1182/71 of the Council (5) should apply. (39) In order to facilitate the application of this Regulation, provision should be made for an obligation on the Member States to communicate certain information regarding their legislation and procedures relating to Preservation Orders and equivalent national orders to the Commission. (40) In order to facilitate the application of this Regulation in practice, standard forms should be established, in particular, for the application for an Order, for the Order itself, for the declaration concerning the preservation of funds and for the application for a remedy or appeal under this Regulation. (41) To increase the efficiency of proceedings, this Regulation should allow for the greatest possible use of modern communication technologies accepted under the procedural rules of the Member States concerned, particularly for the purposes of filling in the standard forms provided for in this Regulation and of communication between the authorities involved in the proceedings. Furthermore, the methods for signing the Preservation Order and other documents under this Regulation should be technologically neutral in order to allow for the application of existing methods, such as digital certification or secure authentication, and for future technical developments in this field. (42) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission with regard to the establishment and subsequent amendment of the standard forms provided for in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). (43) The advisory procedure should be used for the adoption of implementing acts establishing and subsequently amending the standard forms provided for in this Regulation in accordance with Article 4 of Regulation (EU) No 182/2011. (44) This Regulation respects the fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union. In particular, it seeks to ensure respect for private and family life, the protection of personal data, the right to property, and the right to an effective remedy and to a fair trial as established in Articles 7, 8, 17 and 47 thereof respectively. (45) In the context of access to personal data and the use and transmission of such data under this Regulation, the requirements of Directive 95/46/EC of the European Parliament and of the Council (7), as transposed into the national law of the Member States, should be complied with. (46) For the purposes of the application of this Regulation, it is however necessary to lay down certain specific conditions for access to personal data and for the use and transmission of such data. In this context, the opinion of the European Data Protection Supervisor (8) has been taken into account. Notification of the data subject should take place in accordance with national law. However, the notification of the debtor about the disclosure of information relating to his account or accounts should be deferred for 30 days, in order to prevent an early notification from jeopardising the effect of the Preservation Order. (47) Since the objective of this Regulation, namely to establish a Union procedure for a protective measure which enables a creditor to obtain a Preservation Order preventing the subsequent enforcement of the creditor\u2019s claim from being jeopardised through the transfer or withdrawal of funds held by the debtor in a bank account within the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (48) This Regulation should apply only to those Member States which are bound by it in accordance with the Treaties. The procedure for obtaining a Preservation Order provided for in this Regulation should therefore be available only to creditors who are domiciled in a Member State bound by this Regulation and Orders issued under this Regulation should relate only to the preservation of bank accounts which are maintained in such a Member State. (49) In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, Ireland has notified its wish to take part in the adoption and application of this Regulation. (50) In accordance with Articles 1 and 2 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, the United Kingdom is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (51) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application, HAVE ADOPTED THIS REGULATION: CHAPTER 1 SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter 1. This Regulation establishes a Union procedure enabling a creditor to obtain a European Account Preservation Order (\u2018Preservation Order\u2019 or \u2018Order\u2019) which prevents the subsequent enforcement of the creditor\u2019s claim from being jeopardised through the transfer or withdrawal of funds up to the amount specified in the Order which are held by the debtor or on his behalf in a bank account maintained in a Member State. 2. The Preservation Order shall be available to the creditor as an alternative to preservation measures under national law. Article 2 Scope 1. This Regulation applies to pecuniary claims in civil and commercial matters in cross-border cases as defined in Article 3, whatever the nature of the court or tribunal concerned (the \u2018court\u2019). It does not extend, in particular, to revenue, customs or administrative matters or to the liability of the State for acts and omissions in the exercise of State authority (\u2018acta iure imperii\u2019). 2. This Regulation does not apply to: (a) rights in property arising out of a matrimonial relationship or out of a relationship deemed by the law applicable to such relationship to have comparable effects to marriage; (b) wills and succession, including maintenance obligations arising by reason of death; (c) claims against a debtor in relation to whom bankruptcy proceedings, proceedings for the winding-up of insolvent companies or other legal persons, judicial arrangements, compositions, or analogous proceedings have been opened; (d) social security; (e) arbitration. 3. This Regulation does not apply to bank accounts which are immune from seizure under the law of the Member State in which the account is maintained nor to accounts maintained in connection with the operation of any system as defined in point (a) of Article 2 of Directive 98/26/EC of the European Parliament and of the Council (9). 4. This Regulation does not apply to bank accounts held by or with central banks when acting in their capacity as monetary authorities. Article 3 Cross-border cases 1. For the purposes of this Regulation, a cross-border case is one in which the bank account or accounts to be preserved by the Preservation Order are maintained in a Member State other than: (a) the Member State of the court seised of the application for the Preservation Order pursuant to Article 6; or (b) the Member State in which the creditor is domiciled. 2. The relevant moment for determining whether a case is a cross-border case is the date on which the application for the Preservation Order is lodged with the court having jurisdiction to issue the Preservation Order. Article 4 Definitions For the purposes of this Regulation: (1) \u2018bank account\u2019 or \u2018account\u2019 means any account containing funds which is held with a bank in the name of the debtor or in the name of a third party on behalf of the debtor; (2) \u2018bank\u2019 means a credit institution as defined in point (1) of Article 4(1) of Regulation (EU) No 575/2013 of the European Parliament and of the Council (10), including branches, within the meaning of point (17) of Article 4(1) of that Regulation, of credit institutions having their head offices inside or, in accordance with Article 47 of Directive 2013/36/EU of the European Parliament and of the Council (11), outside the Union where such branches are located in the Union; (3) \u2018funds\u2019 means money credited to an account in any currency, or similar claims for the repayment of money, such as money market deposits; (4) \u2018Member State in which the bank account is maintained\u2019 means: (a) the Member State indicated in the account\u2019s IBAN (International Bank Account Number); or (b) for a bank account which does not have an IBAN, the Member State in which the bank with which the account is held has its head office or, where the account is held with a branch, the Member State in which the branch is located; (5) \u2018claim\u2019 means a claim for payment of a specific amount of money that has fallen due or a claim for payment of a determinable amount of money arising from a transaction or an event that has already occurred, provided that such a claim can be brought before a court; (6) \u2018creditor\u2019 means a natural person domiciled in a Member State or a legal person domiciled in a Member State or any other entity domiciled in a Member State having legal capacity to sue or be sued under the law of a Member State, who or which applies for, or has already obtained, a Preservation Order relating to a claim; (7) \u2018debtor\u2019 means a natural person or a legal person or any other entity having legal capacity to sue or be sued under the law of a Member State, against whom or which the creditor seeks to obtain, or has already obtained, a Preservation Order relating to a claim; (8) \u2018judgment\u2019 means any judgment given by a court of a Member State, whatever the judgment may be called, including a decision on the determination of costs or expenses by an officer of the court; (9) \u2018court settlement\u2019 means a settlement which has been approved by a court of a Member State or concluded before a court of a Member State in the course of proceedings; (10) \u2018authentic instrument\u2019 means a document which has been formally drawn up or registered as an authentic instrument in a Member State and the authenticity of which: (a) relates to the signature and the content of the instrument; and (b) has been established by a public authority or other authority empowered for that purpose; (11) \u2018Member State of origin\u2019 means the Member State in which the Preservation Order was issued; (12) \u2018Member State of enforcement\u2019 means the Member State in which the bank account to be preserved is maintained; (13) \u2018information authority\u2019 means the authority which a Member State has designated as competent for the purposes of obtaining the necessary information on the debtor\u2019s account or accounts pursuant to Article 14; (14) \u2018competent authority\u2019 means the authority or authorities which a Member State has designated as competent for receipt, transmission or service pursuant to Article 10(2), Article 23(3), (5) and (6), Articles 25(3), 27(2) and 28(3) and the second subparagraph of Article 36(5); (15) \u2018domicile\u2019 means domicile as determined in accordance with Articles 62 and 63 of Regulation (EU) No 1215/2012 of the European Parliament and of the Council (12). CHAPTER 2 PROCEDURE FOR OBTAINING A PRESERVATION ORDER Article 5 Availability The Preservation Order shall be available to the creditor in the following situations: (a) before the creditor initiates proceedings in a Member State against the debtor on the substance of the matter, or at any stage during such proceedings up until the issuing of the judgment or the approval or conclusion of a court settlement; (b) after the creditor has obtained in a Member State a judgment, court settlement or authentic instrument which requires the debtor to pay the creditor\u2019s claim. Article 6 Jurisdiction 1. Where the creditor has not yet obtained a judgment, court settlement or authentic instrument, jurisdiction to issue a Preservation Order shall lie with the courts of the Member State which have jurisdiction to rule on the substance of the matter in accordance with the relevant rules of jurisdiction applicable. 2. Notwithstanding paragraph 1, where the debtor is a consumer who has concluded a contract with the creditor for a purpose which can be regarded as being outside the debtor\u2019s trade or profession, jurisdiction to issue a Preservation Order intended to secure a claim relating to that contract shall lie only with the courts of the Member State in which the debtor is domiciled. 3. Where the creditor has already obtained a judgment or court settlement, jurisdiction to issue a Preservation Order for the claim specified in the judgment or court settlement shall lie with the courts of the Member State in which the judgment was issued or the court settlement was approved or concluded. 4. Where the creditor has obtained an authentic instrument, jurisdiction to issue a Preservation Order for the claim specified in that instrument shall lie with the courts designated for that purpose in the Member State in which that instrument was drawn up. Article 7 Conditions for issuing a Preservation Order 1. The court shall issue the Preservation Order when the creditor has submitted sufficient evidence to satisfy the court that there is an urgent need for a protective measure in the form of a Preservation Order because there is a real risk that, without such a measure, the subsequent enforcement of the creditor\u2019s claim against the debtor will be impeded or made substantially more difficult. 2. Where the creditor has not yet obtained in a Member State a judgment, court settlement or authentic instrument requiring the debtor to pay the creditor\u2019s claim, the creditor shall also submit sufficient evidence to satisfy the court that he is likely to succeed on the substance of his claim against the debtor. Article 8 Application for a Preservation Order 1. Applications for a Preservation Order shall be lodged using the form established in accordance with the advisory procedure referred to in Article 52(2). 2. The application shall include the following information: (a) the name and address of the court with which the application is lodged; (b) details concerning the creditor: name and contact details and, where applicable, name and contact details of the creditor\u2019s representative, and: (i) where the creditor is a natural person, his date of birth and, if applicable and available, his identification or passport number; or (ii) where the creditor is a legal person or any other entity having legal capacity to sue or be sued under the law of a Member State, the State of its incorporation, formation or registration and its identification or registration number or, where no such number exists, the date and place of its incorporation, formation or registration; (c) details concerning the debtor: name and contact details and, where applicable, name and contact details of the debtor\u2019s representative and, if available: (i) where the debtor is a natural person, his date of birth and identification or passport number; or (ii) where the debtor is a legal person or any other entity having legal capacity to sue or be sued under the law of a Member State, the State of its incorporation, formation or registration and its identification or registration number or, where no such number exists, the date and place of its incorporation, formation or registration; (d) a number enabling the identification of the bank, such as the IBAN or BIC and/or the name and address of the bank, with which the debtor holds one or more accounts to be preserved; (e) if available, the number of the account or accounts to be preserved and, in such a case, an indication as to whether any other accounts held by the debtor with the same bank should be preserved; (f) where none of the information required under point (d) can be provided, a statement that a request is made for the obtaining of account information pursuant to Article 14, where such a request is possible, and a substantiation as to why the creditor believes that the debtor holds one or more accounts with a bank in a specific Member State; (g) the amount for which the Preservation Order is sought: (i) where the creditor has not yet obtained a judgment, court settlement or authentic instrument, the amount of the principal claim or part thereof and of any interest recoverable pursuant to Article 15; (ii) where the creditor has already obtained a judgment, court settlement or authentic instrument, the amount of the principal claim as specified in the judgment, court settlement or authentic instrument or part thereof and of any interest and costs recoverable pursuant to Article 15; (h) where the creditor has not yet obtained a judgment, court settlement or authentic instrument: (i) a description of all relevant elements supporting the jurisdiction of the court with which the application for the Preservation Order is lodged; (ii) a description of all relevant circumstances invoked as the basis of the claim, and, where applicable, of the interest claimed; (iii) a statement indicating whether the creditor has already initiated proceedings against the debtor on the substance of the matter; (i) where the creditor has already obtained a judgment, court settlement or authentic instrument, a declaration that the judgment, court settlement or authentic instrument has not yet been complied with or, where it has been complied with in part, an indication of the extent of non-compliance; (j) a description of all relevant circumstances justifying the issuing of the Preservation Order as required by Article 7(1); (k) where applicable, an indication of the reasons why the creditor believes he should be exempted from providing security pursuant to Article 12; (l) a list of the evidence provided by the creditor; (m) a declaration as provided for in Article 16 as to whether the creditor has lodged with other courts or authorities an application for an equivalent national order or whether such an order has already been obtained or refused and, if obtained, the extent to which it has been implemented; (n) an optional indication of the creditor\u2019s bank account to be used for any voluntary payment of the claim by the debtor; (o) a declaration that the information provided by the creditor in the application is true and complete to the best of his knowledge and that the creditor is aware that any deliberately false or incomplete statements may lead to legal consequences under the law of the Member State in which the application is lodged or to liability pursuant to Article 13. 3. The application shall be accompanied by all relevant supporting documents and, where the creditor has already obtained a judgment, court settlement or authentic instrument, by a copy of the judgment, court settlement or authentic instrument which satisfies the conditions necessary to establish its authenticity. 4. The application and supporting documents may be submitted by any means of communication, including electronic, which are accepted under the procedural rules of the Member State in which the application is lodged. Article 9 Taking of evidence 1. The court shall take its decision by means of a written procedure on the basis of the information and evidence provided by the creditor in or with his application. If the court considers that the evidence provided is insufficient, it may, where national law so allows, request the creditor to provide additional documentary evidence. 2. Notwithstanding paragraph 1 and subject to Article 11, the court may, provided that this does not delay the proceedings unduly, also use any other appropriate method of taking evidence available under its national law, such as an oral hearing of the creditor or of his witness(es) including through videoconference or other communication technology. Article 10 Initiation of proceedings on the substance of the matter 1. Where the creditor has applied for a Preservation Order before initiating proceedings on the substance of the matter, he shall initiate such proceedings and provide proof of such initiation to the court with which the application for the Preservation Order was lodged within 30 days of the date on which he lodged the application or within 14 days of the date of the issue of the Order, whichever date is the later. The court may also, at the request of the debtor, extend that time period, for example in order to allow the parties to settle the claim, and shall inform the two parties accordingly. 2. If the court has not received proof of the initiation of proceedings within the time period referred to in paragraph 1, the Preservation Order shall be revoked or shall terminate and the parties shall be informed accordingly. Where the court that issued the Order is located in the Member State of enforcement, the revocation or termination of the Order in that Member State shall be done in accordance with the law of that Member State. Where the revocation or termination needs to be implemented in a Member State other than the Member State of origin, the court shall revoke the Preservation Order by using the revocation form established by means of implementing acts adopted in accordance with the advisory procedure referred to in Article 52(2), and shall transmit the revocation form in accordance with Article 29 to the competent authority of the Member State of enforcement. That authority shall take the necessary steps by applying Article 23 as appropriate to have the revocation or termination implemented. 3. For the purposes of paragraph 1, proceedings on the substance of the matter shall be deemed to have been initiated: (a) at the time when the document instituting the proceedings or an equivalent document is lodged with the court, provided that the creditor has not subsequently failed to take the steps he was required to take to have service effected on the debtor; or (b) if the document has to be served before being lodged with the court, at the time when it is received by the authority responsible for service, provided that the creditor has not subsequently failed to take the steps he was required to take to have the document lodged with the court. The authority responsible for service referred to in point (b) of the first subparagraph shall be the first authority receiving the documents to be served. Article 11 Ex parte procedure The debtor shall not be notified of the application for a Preservation Order or be heard prior to the issuing of the Order. Article 12 Security to be provided by the creditor 1. Before issuing a Preservation Order in a case where the creditor has not yet obtained a judgment, court settlement or authentic instrument, the court shall require the creditor to provide security for an amount sufficient to prevent abuse of the procedure provided for by this Regulation and to ensure compensation for any damage suffered by the debtor as a result of the Order to the extent that the creditor is liable for such damage pursuant to Article 13. By way of exception, the court may dispense with the requirement set out in the first subparagraph if it considers that the provision of security referred to in that subparagraph is inappropriate in the circumstances of the case. 2. Where the creditor has already obtained a judgment, court settlement or authentic instrument, the court may, before issuing the Order, require the creditor to provide security as referred to in the first subparagraph of paragraph 1 if it considers this necessary and appropriate in the circumstances of the case. 3. If the court requires security to be provided pursuant to this Article, it shall inform the creditor of the amount required and of the forms of security acceptable under the law of the Member State in which the court is located. It shall indicate to the creditor that it will issue the Preservation Order once security in accordance with those requirements has been provided. Article 13 Liability of the creditor 1. The creditor shall be liable for any damage caused to the debtor by the Preservation Order due to fault on the creditor\u2019s part. The burden of proof shall lie with the debtor. 2. In the following cases, the fault of the creditor shall be presumed unless he proves otherwise: (a) if the Order is revoked because the creditor has failed to initiate proceedings on the substance of the matter, unless that omission was a consequence of the debtor\u2019s payment of the claim or another form for settlement between the parties; (b) if the creditor has failed to request the release of over-preserved amounts as provided for in Article 27; (c) if it is subsequently found that the issue of the Order was not appropriate or appropriate only in a lower amount due to a failure on the part of the creditor to comply with his obligations under Article 16; or (d) if the Order is revoked or its enforcement terminated because the creditor has failed to comply with his obligations under this Regulation with regard to service or translation of documents or with regard to curing the lack of service or the lack of translation. 3. Notwithstanding paragraph 1, Member States may maintain or introduce in their national law other grounds or types of liability or rules on the burden of proof. All other aspects relating to the creditor\u2019s liability towards the debtor not specifically addressed in paragraph 1 or 2 shall be governed by national law. 4. The law applicable to the liability of the creditor shall be the law of the Member State of enforcement. If accounts are preserved in more than one Member State, the law applicable to the liability of the creditor shall be the law of the Member State of enforcement: (a) in which the debtor has his habitual residence as defined in Article 23 of Regulation (EC) No 864/2007 of the European Parliament and of the Council (13), or, failing that, (b) which has the closest connection with the case. 5. This Article does not deal with the question of possible liability of the creditor towards the bank or any third party. Article 14 Request for the obtaining of account information 1. Where the creditor has obtained in a Member State an enforceable judgment, court settlement or authentic instrument which requires the debtor to pay the creditor\u2019s claim and the creditor has reasons to believe that the debtor holds one or more accounts with a bank in a specific Member State, but knows neither the name and/or address of the bank nor the IBAN, BIC or another bank number allowing the bank to be identified, he may request the court with which the application for the Preservation Order is lodged to request that the information authority of the Member State of enforcement obtain the information necessary to allow the bank or banks and the debtor\u2019s account or accounts to be identified. Notwithstanding the first subparagraph, the creditor may make the request referred to in that subparagraph where the judgment, court settlement or authentic instrument obtained by the creditor is not yet enforceable and the amount to be preserved is substantial taking into account the relevant circumstances, and the creditor has submitted sufficient evidence to satisfy the court that there is an urgent need for account information because there is a risk that, without such information, the subsequent enforcement of the creditor\u2019s claim against the debtor is likely to be jeopardised and that this could consequently lead to a substantial deterioration of the creditor\u2019s financial situation. 2. The creditor shall make the request referred to in paragraph 1 in the application for the Preservation Order. The creditor shall substantiate why he believes that the debtor holds one or more accounts with a bank in the specific Member State and shall provide all relevant information available to him about the debtor and the account or accounts to be preserved. If the court with which the application for a Preservation Order is lodged considers that the creditor\u2019s request is not sufficiently substantiated, it shall reject it. 3. When the court is satisfied that the creditor\u2019s request is well substantiated and that all the conditions and requirements for issuing the Preservation Order are met, except for the information requirement set out in point (d) of Article 8(2) and, where applicable, the security requirement pursuant to Article 12, the court shall transmit the request for information to the information authority of the Member State of enforcement in accordance with Article 29. 4. To obtain the information referred to in paragraph 1, the information authority in the Member State of enforcement shall use one of the methods available in that Member State pursuant to paragraph 5. 5. Each Member State shall make available in its national law at least one of the following methods of obtaining the information referred to in paragraph 1: (a) an obligation on all banks in its territory to disclose, upon request by the information authority, whether the debtor holds an account with them; (b) access for the information authority to the relevant information where that information is held by public authorities or administrations in registers or otherwise; (c) the possibility for its courts to oblige the debtor to disclose with which bank or banks in its territory he holds one or more accounts where such an obligation is accompanied by an in personam order by the court prohibiting the withdrawal or transfer by him of funds held in his account or accounts up to the amount to be preserved by the Preservation Order; or (d) any other methods which are effective and efficient for the purposes of obtaining the relevant information, provided that they are not disproportionately costly or time-consuming. Irrespective of the method or methods made available by a Member State, all authorities involved in obtaining the information shall act expeditiously. 6. As soon as the information authority of the Member State of enforcement has obtained the account information, it shall transmit it to the requesting court in accordance with Article 29. 7. If the information authority is unable to obtain the information referred to in paragraph 1, it shall inform the requesting court accordingly. Where, as a result of the unavailability of account information, the application for a Preservation Order is rejected in full, the requesting court shall without delay release any security that the creditor may have provided pursuant to Article 12. 8. Where under this Article the information authority is provided with information by a bank or is granted access to account information held by public authorities or administrations in registers, the notification of the debtor of the disclosure of his personal data shall be deferred for 30 days, in order to prevent an early notification from jeopardising the effect of the Preservation Order. Article 15 Interest and costs 1. At the request of the creditor, the Preservation Order shall include any interest accrued under the law applicable to the claim up to the date when the Order is issued, provided that the amount or type of interest is not such that its inclusion constitutes a violation of overriding mandatory provisions in the law of the Member State of origin. 2. Where the creditor has already obtained a judgment, court settlement or authentic instrument, the Preservation Order shall, at the request of the creditor, also include the costs of obtaining such judgment, settlement or instrument, to the extent that a determination has been made that those costs must be borne by the debtor. Article 16 Parallel applications 1. The creditor may not submit to several courts at the same time parallel applications for a Preservation Order against the same debtor aimed at securing the same claim. 2. In his application for a Preservation Order, the creditor shall declare whether he has lodged with any other court or authority an application for an equivalent national order against the same debtor and aimed at securing the same claim or has already obtained such an order. He shall also indicate any applications for such an order which have been rejected as inadmissible or unfounded. 3. If the creditor obtains an equivalent national order against the same debtor and aimed at securing the same claim during the proceedings for the issuing of a Preservation Order, he shall without delay inform the court thereof and of any subsequent implementation of the national order granted. He shall also inform the court of any applications for an equivalent national order which have been rejected as inadmissible or unfounded. 4. Where the court is informed that the creditor has already obtained an equivalent national order, it shall consider, having regard to all the circumstances of the case, whether it is still appropriate to issue the Preservation Order, in full or in part. Article 17 Decision on the application for the Preservation Order 1. The court seised of an application for a Preservation Order shall examine whether the conditions and requirements set out in this Regulation are met. 2. The court shall decide on the application without delay, but no later than by the expiry of the time-limits set out in Article 18. 3. Where the creditor has not provided all the information required by Article 8, the court may, unless the application is clearly inadmissible or unfounded, give the creditor the opportunity to complete or rectify the application within a period of time to be specified by the court. If the creditor fails to complete or rectify the application within that period, the application shall be rejected. 4. The Preservation Order shall be issued in the amount justified by the evidence referred to in Article 9 and as determined by the law applicable to the underlying claim, and shall include, where appropriate, interest and/or costs pursuant to Article 15. The Order may not under any circumstances be issued in an amount exceeding the amount indicated by the creditor in his application. 5. The decision on the application shall be brought to the notice of the creditor in accordance with the procedure provided for by the law of the Member State of origin for equivalent national orders. Article 18 Time-limits for the decision on the application for a Preservation Order 1. Where the creditor has not yet obtained a judgment, court settlement or authentic instrument, the court shall issue its decision by the end of the tenth working day after the creditor lodged or, where applicable, completed his application. 2. Where the creditor has already obtained a judgment, court settlement or authentic instrument, the court shall issue its decision by the end of the fifth working day after the creditor lodged or, where applicable, completed his application. 3. Where the court determines pursuant to Article 9(2) that an oral hearing of the creditor and, as the case may be, his witness(es) is necessary, the court shall hold the hearing without delay and shall issue its decision by the end of the fifth working day after the hearing has taken place. 4. In the situations referred to in Article 12, the time-limits set out in paragraphs 1, 2 and 3 of this Article shall apply to the decision requiring the creditor to provide security. The court shall issue its decision on the application for a Preservation Order without delay once the creditor has provided the security required. 5. Notwithstanding paragraphs 1, 2 and 3 of this Article, in situations referred to in Article 14, the court shall issue its decision without delay once it has received the information referred to in Article 14(6) or (7), provided that any security required has been provided by the creditor by that time. Article 19 Form and content of the Preservation Order 1. The Preservation Order shall be issued using the form established by means of implementing acts adopted in accordance with the advisory procedure referred to in Article 52(2) and shall bear a stamp, a signature and/or any other authentication of the court. The form shall consist of two parts: (a) part A, containing the information set out in paragraph 2 to be provided to the bank, the creditor and the debtor; and (b) part B, containing the information set out in paragraph 3 to be provided to the creditor and the debtor in addition to the information pursuant to paragraph 2. 2. Part A shall include the following information: (a) the name and address of the court and the file number of the case; (b) details of the creditor as indicated in point (b) of Article 8(2); (c) details of the debtor as indicated in point (c) of Article 8(2); (d) the name and address of the bank concerned by the Order; (e) if the creditor has provided the account number of the debtor in the application, the number of the account or accounts to be preserved, and, where applicable, an indication as to whether any other accounts held by the debtor with the same bank also have to be preserved; (f) where applicable, an indication that the number of any account to be preserved was obtained by means of a request pursuant to Article 14 and that the bank, where necessary pursuant to the second subparagraph of Article 24(4), is to obtain the number or numbers concerned from the information authority of the Member State of enforcement; (g) the amount to be preserved by the Order; (h) an instruction to the bank to implement the Order in accordance with Article 24; (i) the date of issue of the Order; (j) if the creditor has indicated an account in his application pursuant to point (n) of Article 8(2), an authorisation to the bank pursuant to Article 24(3) to release and transfer, if so requested by the debtor and if allowed by the law of the Member State of enforcement, funds up to the amount specified in the Order from the preserved account to the account that the creditor has indicated in his application; (k) information on where to find the electronic version of the form to be used for the declaration pursuant to Article 25. 3. Part B shall include the following information: (a) a description of the subject matter of the case and the court\u2019s reasoning for issuing the Order; (b) the amount of the security provided by the creditor, if any; (c) where applicable, the time-limit for initiating the proceedings on the substance of the matter and for proving such initiation to the issuing court; (d) where applicable, an indication as to which documents must be translated pursuant to the second sentence of Article 49(1); (e) where applicable, an indication that the creditor is responsible for initiating the enforcement of the Order and consequently, where applicable, an indication that the creditor is responsible for transmitting it to the competent authority of the Member State of enforcement pursuant to Article 23(3) and for initiating service on the debtor pursuant to Article 28(2), (3) and (4); and (f) information about the remedies available to the debtor. 4. Where the Preservation Order concerns accounts in different banks, a separate form (part A pursuant to paragraph 2) shall be filled in for each bank. In such a case, the form provided to the creditor and the debtor (parts A and B pursuant to paragraphs 2 and 3 respectively) shall contain a list of all banks concerned. Article 20 Duration of the preservation The funds preserved by the Preservation Order shall remain preserved as provided for in the Order or in any subsequent modification or limitation of that Order pursuant to Chapter 4: (a) until the Order is revoked; (b) until the enforcement of the Order is terminated; or (c) until a measure to enforce a judgment, court settlement or authentic instrument obtained by the creditor relating to the claim which the Preservation Order was aimed at securing has taken effect with respect to the funds preserved by the Order. Article 21 Appeal against a refusal to issue the Preservation Order 1. The creditor shall have the right to appeal against any decision of the court rejecting, wholly or in part, his application for a Preservation Order. 2. Such an appeal shall be lodged within 30 days of the date on which the decision referred to in paragraph 1 was brought to the notice of the creditor. It shall be lodged with the court which the Member State concerned has communicated to the Commission pursuant to point (d) of Article 50(1). 3. Where the application for the Preservation Order was rejected in whole, the appeal shall be dealt with in ex parte proceedings as provided for in Article 11. CHAPTER 3 RECOGNITION, ENFORCEABILITY AND ENFORCEMENT OF THE PRESERVATION ORDER Article 22 Recognition and enforceability A Preservation Order issued in a Member State in accordance with this Regulation shall be recognised in the other Member States without any special procedure being required and shall be enforceable in the other Member States without the need for a declaration of enforceability. Article 23 Enforcement of the Preservation Order 1. Subject to the provisions of this Chapter, the Preservation Order shall be enforced in accordance with the procedures applicable to the enforcement of equivalent national orders in the Member State of enforcement. 2. All authorities involved in the enforcement of the Order shall act without delay. 3. Where the Preservation Order was issued in a Member State other than the Member State of enforcement, part A of the Order as indicated in Article 19(2) and a blank standard form for the declaration pursuant to Article 25 shall, for the purposes of paragraph 1 of this Article, be transmitted in accordance with Article 29 to the competent authority of the Member State of enforcement. The transmission shall be done by the issuing court or the creditor, depending on who is responsible under the law of the Member State of origin for initiating the enforcement procedure. 4. The Order shall be accompanied, where necessary, by a translation or transliteration into the official language of the Member State of enforcement or, where there are several official languages in that Member State, the official language or one of the official languages of the place where the Order is to be implemented. Such translation or transliteration shall be provided by the issuing court by making use of the appropriate language version of the standard form referred to in Article 19. 5. The competent authority of the Member State of enforcement shall take the necessary steps to have the Order enforced in accordance with its national law. 6. Where the Preservation Order concerns more than one bank in the same Member State or in different Member States, a separate form for each bank as indicated in Article 19(4) shall be transmitted to the competent authority in the relevant Member State of enforcement. Article 24 Implementation of the Preservation Order 1. A bank to which a Preservation Order is addressed shall implement it without delay following receipt of the Order or, where the law of the Member State of enforcement so provides, of a corresponding instruction to implement the Order. 2. To implement the Preservation Order, the bank shall, subject to the provisions of Article 31, preserve the amount specified in the Order either: (a) by ensuring that that amount is not transferred or withdrawn from the account or accounts indicated in the Order or identified pursuant to paragraph 4; or (b) where national law so provides, by transferring that amount to an account dedicated for preservation purposes. The final amount preserved may be subject to the settlement of transactions which are already pending at the moment when the Order or a corresponding instruction is received by the bank. However, such pending transactions may only be taken into account when they are settled before the bank issues the declaration pursuant to Article 25 by the time-limits set out in Article 25(1). 3. Notwithstanding point (a) of paragraph 2, the bank shall be authorised, at the request of the debtor, to release funds preserved and to transfer those funds to the account of the creditor indicated in the Order for the purposes of paying the creditor\u2019s claim, if all the following conditions are met: (a) such authorisation of the bank is specifically indicated in the Order in accordance with point (j) of Article 19(2); (b) the law of the Member State of enforcement allows for such release and transfer; and (c) there are no competing Orders with regard to the account concerned. 4. Where the Preservation Order does not specify the number or numbers of the account or accounts of the debtor but provides only the name and other details regarding the debtor, the bank or other entity responsible for enforcing the Order shall identify the account or accounts held by the debtor with the bank indicated in the Order. If, on the basis of the information provided in the Order, it is not possible for the bank or other entity to identify with certainty an account of the debtor, the bank shall: (a) where, in accordance with point (f) of Article 19(2), it is indicated in the Order that the number or numbers of the account or accounts to be preserved was or were obtained by means of a request pursuant to Article 14, obtain that number or those numbers from the information authority of the Member State of enforcement; and (b) in all other cases, not implement the Order. 5. Any funds held in the account or accounts referred to in point (a) of paragraph 2 which exceed the amount specified in the Preservation Order shall remain unaffected by the implementation of the Order. 6. Where, at the time of the implementation of the Preservation Order, the funds held in the account or accounts referred to in point (a) of paragraph 2 are insufficient to preserve the full amount specified in the Order, the Order shall be implemented only in the amount available in the account or accounts. 7. Where the Preservation Order covers several accounts held by the debtor with the same bank and those accounts contain funds that exceed the amount specified in the Order, the Order shall be implemented in the following order of priority: (a) savings accounts in the sole name of the debtor; (b) current accounts in the sole name of the debtor; (c) savings accounts in joint names, subject to Article 30; (d) current accounts in joint names, subject to Article 30. 8. Where the currency of the funds held in the account or accounts referred to in point (a) of paragraph 2 is not the same as that in which the Preservation Order was issued, the bank shall convert the amount specified in the Order into the currency of the funds by reference to the foreign exchange reference rate of the European Central Bank or the exchange rate of the central bank of the Member State of enforcement for sale of that currency on the day and at the time of the implementation of the Order, and shall preserve the corresponding amount in the currency of the funds. Article 25 Declaration concerning the preservation of funds 1. By the end of the third working day following the implementation of the Preservation Order, the bank or other entity responsible for enforcing the Order in the Member State of enforcement shall issue a declaration using the declaration form established by means of implementing acts adopted in accordance with the advisory procedure referred to in Article 52(2), indicating whether and to what extent funds in the debtor\u2019s account or accounts have been preserved and, if so, on which date the Order was implemented. If, in exceptional circumstances, it is not possible for the bank or other entity to issue the declaration within three working days, it shall issue it as soon as possible but by no later than the end of the eighth working day following the implementation of the Order. The declaration shall be transmitted, without delay, in accordance with paragraphs 2 and 3. 2. Where the Order was issued in the Member State of enforcement, the bank or other entity responsible for enforcing the Order shall transmit the declaration in accordance with Article 29 to the issuing court and by registered post attested by an acknowledgment of receipt, or by equivalent electronic means, to the creditor. 3. Where the Order was issued in a Member State other than the Member State of enforcement, the declaration shall be transmitted in accordance with Article 29 to the competent authority of the Member State of enforcement, unless it was issued by that same authority. By the end of the first working day following the receipt or issue of the declaration, that authority shall transmit the declaration in accordance with Article 29 to the issuing court and by registered post attested by an acknowledgment of receipt, or by equivalent electronic means, to the creditor. 4. The bank or other entity responsible for enforcing the Preservation Order shall, upon request by the debtor, disclose to the debtor the details of the Order. The bank or entity may also do so in the absence of such a request. Article 26 Liability of the bank Any liability of the bank for failure to comply with its obligations under this Regulation shall be governed by the law of the Member State of enforcement. Article 27 Duty of the creditor to request the release of over-preserved amounts 1. The creditor shall be under a duty to take the necessary steps to ensure the release of any amount which, following the implementation of the Preservation Order, exceeds the amount specified in the Preservation Order: (a) where the Order covers several accounts in the same Member State or in different Member States; or (b) where the Order was issued after the implementation of one or more equivalent national orders against the same debtor and aimed at securing the same claim. 2. By the end of the third working day following receipt of any declaration pursuant to Article 25 showing such over-preservation, the creditor shall, by the swiftest possible means and using the form for requesting the release of over-preserved amounts, established by means of implementing acts adopted in accordance with the advisory procedure referred to in Article 52(2), submit a request for the release to the competent authority of the Member State of enforcement in which the over-preservation has occurred. That authority shall, upon receipt of the request, promptly instruct the bank concerned to effect the release of the over-preserved amounts. Article 24(7) shall apply, as appropriate, in the reverse order of priority. 3. This Article shall not preclude a Member State from providing in its national law that the release of over-preserved funds from any account maintained in its territory is to be initiated by the competent enforcement authority of that Member State of its own motion. Article 28 Service on the debtor 1. The Preservation Order, the other documents referred to in paragraph 5 of this Article and the declaration pursuant to Article 25 shall be served on the debtor in accordance with this Article. 2. Where the debtor is domiciled in the Member State of origin, service shall be effected in accordance with the law of that Member State. Service shall be initiated by the issuing court or the creditor, depending on who is responsible for initiating service in the Member State of origin, by the end of the third working day following the day of receipt of the declaration pursuant to Article 25 showing that amounts have been preserved. 3. Where the debtor is domiciled in a Member State other than the Member State of origin, the issuing court or the creditor, depending on who is responsible for initiating service in the Member State of origin, shall, by the end of the third working day following the day of receipt of the declaration pursuant to Article 25 showing that amounts have been preserved, transmit the documents referred to in paragraph 1 of this Article in accordance with Article 29 to the competent authority of the Member State in which the debtor is domiciled. That authority shall, without delay, take the necessary steps to have service effected on the debtor in accordance with the law of the Member State in which the debtor is domiciled. Where the Member State in which the debtor is domiciled is the only Member State of enforcement, the documents referred to in paragraph 5 of this Article shall be transmitted to the competent authority of that Member State at the time of transmission of the Order in accordance with Article 23(3). In such a case, that competent authority shall initiate the service of all documents referred to in paragraph 1 of this Article by the end of the third working day following the day of receipt or issue of the declaration pursuant to Article 25 showing that amounts have been preserved. The competent authority shall inform the issuing court or the creditor, depending on who transmitted the documents to be served, of the result of the service on the debtor. 4. Where the debtor is domiciled in a third State, service shall be effected in accordance with the rules on international service applicable in the Member State of origin. 5. The following documents shall be served on the debtor and shall, where necessary, be accompanied by a translation or transliteration as provided for in Article 49(1): (a) the Preservation Order using parts A and B of the form referred to in Article 19(2) and (3); (b) the application for the Preservation Order submitted by the creditor to the court; (c) copies of all documents submitted by the creditor to the court in order to obtain the Order. 6. Where the Preservation Order concerns more than one bank, only the first declaration pursuant to Article 25 showing that amounts have been preserved shall be served on the debtor in accordance with this Article. Any subsequent declarations pursuant to Article 25 shall be brought to the notice of the debtor without delay. Article 29 Transmission of documents 1. Where this Regulation provides for transmission of documents in accordance with this Article, such transmission may be carried out by any appropriate means, provided that the content of the document received is true and faithful to that of the document transmitted and that all information contained in it is easily legible. 2. The court or authority that received documents in accordance with paragraph 1 of this Article shall, by the end of the working day following the day of receipt, send to the authority, creditor or bank that transmitted the documents an acknowledgment of receipt, employing the swiftest possible means of transmission and using the standard form established by means of implementing acts adopted in accordance with the advisory procedure referred to in Article 52(2). Article 30 Preservation of joint and nominee accounts Funds held in accounts which, according to the bank\u2019s records, are not exclusively held by the debtor or are held by a third party on behalf of the debtor or by the debtor on behalf of a third party, may be preserved under this Regulation only to the extent to which they may be subject to preservation under the law of the Member State of enforcement. Article 31 Amounts exempt from preservation 1. Amounts that are exempt from seizure under the law of the Member State of enforcement shall be exempt from preservation under this Regulation. 2. Where, under the law of the Member State of enforcement, the amounts referred to in paragraph 1 are exempted from seizure without any request from the debtor, the body responsible for exempting such amounts in that Member State shall, of its own motion, exempt the relevant amounts from preservation. 3. Where, under the law of the Member State of enforcement, the amounts referred to in paragraph 1 of this Article are exempted from seizure at the request of the debtor, such amounts shall be exempted from preservation upon application by the debtor as provided for by point (a) of Article 34(1). Article 32 Ranking of the Preservation Order The Preservation Order shall have the same rank, if any, as an equivalent national order in the Member State of enforcement. CHAPTER 4 REMEDIES Article 33 Remedies of the debtor against the Preservation Order 1. Upon application by the debtor to the competent court of the Member State of origin, the Preservation Order shall be revoked or, where applicable, modified on the ground that: (a) the conditions or requirements set out in this Regulation were not met; (b) the Order, the declaration pursuant to Article 25 and/or the other documents referred to in Article 28(5) were not served on the debtor within 14 days of the preservation of his account or accounts; (c) the documents served on the debtor in accordance with Article 28 did not meet the language requirements set out in Article 49(1); (d) preserved amounts exceeding the amount of the Order were not released in accordance with Article 27; (e) the claim the enforcement of which the creditor was seeking to secure by means of the Order has been paid in full or in part; (f) a judgment on the substance of the matter has dismissed the claim the enforcement of which the creditor was seeking to secure by means of the Order; or (g) the judgment on the substance of the matter, or the court settlement or authentic instrument, the enforcement of which the creditor was seeking to secure by means of the Order has been set aside or, as the case may be, annulled. 2. Upon application by the debtor to the competent court of the Member State of origin, the decision concerning the security pursuant to Article 12 shall be reviewed on the ground that the conditions or requirements of that Article were not met. Where, on the basis of such a remedy, the court requires the creditor to provide security or additional security, the first sentence of Article 12(3) shall apply as appropriate and the court shall indicate that the Preservation Order will be revoked or modified if the (additional) security required is not provided by the time-limit specified by the court. 3. The remedy applied for under point (b) of paragraph 1 shall be granted unless the lack of service is cured within 14 days of the creditor being informed of the debtor's application for a remedy pursuant to point (b) of paragraph 1. Unless the lack of service was already cured by other means, the lack of service shall, for the purposes of assessing whether or not the remedy pursuant to point (b) of paragraph 1 is to be granted, be deemed to be cured: (a) if the creditor requests the body responsible for service under the law of the Member State of origin to serve the documents on the debtor; or (b) where the debtor has indicated in his application for a remedy that he agrees to collect the documents at the court of the Member State of origin and where the creditor was responsible for providing translations, if the creditor transmits to that court any translations required pursuant to Article 49(1). The body responsible for service under the law of the Member State of origin shall, at the request of the creditor pursuant to point (a) of the second subparagraph of this paragraph, without delay serve the documents on the debtor by registered post attested by an acknowledgment of receipt at the address indicated by the debtor in accordance with paragraph 5 of this Article. Where the creditor was responsible for initiating the service of the documents referred to in Article 28, a lack of service may only be cured if the creditor demonstrates that he had taken all the steps he was required to take to have the initial service of the documents effected. 4. The remedy applied for under point (c) of paragraph 1 shall be granted unless the creditor provides to the debtor the translations required pursuant to this Regulation within 14 days of the creditor being informed of the application by the debtor for a remedy pursuant to point (c) of paragraph 1. The second and third subparagraphs of paragraph 3 shall apply as appropriate. 5. In his application for a remedy under points (b) and (c) of paragraph 1, the debtor shall indicate an address to which the documents and the translations referred to in Article 28 can be sent in accordance with paragraphs 3 and 4 of this Article or, alternatively, shall indicate that he agrees to collect those documents at the court of the Member State of origin. Article 34 Remedies of the debtor against enforcement of the Preservation Order 1. Notwithstanding Articles 33 and 35, upon application by the debtor to the competent court or, where national law so provides, to the competent enforcement authority in the Member State of enforcement, the enforcement of the Preservation Order in that Member State shall be: (a) limited on the ground that certain amounts held in the account should be exempt from seizure in accordance with Article 31(3), or that amounts exempt from seizure have not or not correctly been taken into account in the implementation of the Order in accordance with Article 31(2); or (b) terminated on the ground that: (i) the account preserved is excluded from the scope of this Regulation pursuant to Article 2(3) and (4); (ii) enforcement of the judgment, court settlement or authentic instrument which the creditor was seeking to secure by means of the Order has been refused in the Member State of enforcement; (iii) the enforceability of the judgment the enforcement of which the creditor was seeking to secure by means of the Order has been suspended in the Member State of origin; or (iv) point (b), (c), (d), (e), (f) or (g) of Article 33(1) applies. Article 33(3), (4) and (5) shall apply as appropriate. 2. Upon application by the debtor to the competent court in the Member State of enforcement, the enforcement of the Preservation Order in that Member State shall be terminated if it is manifestly contrary to the public policy (ordre public) of the Member State of enforcement. Article 35 Other remedies available to the debtor and the creditor 1. The debtor or the creditor may apply to the court that issued the Preservation Order for a modification or a revocation of the Order on the ground that the circumstances on the basis of which the Order was issued have changed. 2. The court that issued the Preservation Order may also, where the law of the Member State of origin so permits, of its own motion modify or revoke the Order due to changed circumstances. 3. The debtor and the creditor may, on the ground that they have agreed to settle the claim, apply jointly to the court that issued the Preservation Order for revocation or modification of the Order or to the competent court of the Member State of enforcement or, where national law so provides, to the competent enforcement authority in that Member State, for termination or limitation of the enforcement of the Order. 4. The creditor may apply to the competent court of the Member State of enforcement or, where national law so provides, to the competent enforcement authority in that Member State, for modification of the enforcement of the Preservation Order, consisting of an adjustment to the exemption applied in that Member State pursuant to Article 31, on the ground that other exemptions have already been applied in a sufficiently high amount in relation to one or several accounts maintained in one or more other Member States and that an adjustment is therefore appropriate. Article 36 Procedure for the remedies pursuant to Articles 33, 34 and 35 1. The application for a remedy pursuant to Article 33, 34 or 35 shall be made using the remedy form established by means of implementing acts adopted in accordance with the advisory procedure referred to in Article 52(2). The application may be made at any time and may be submitted by any means of communication, including electronic means, which are accepted under the procedural rules of the Member State in which the application is lodged. 2. The application shall be brought to the notice of the other party. 3. Except where the application was submitted by the debtor pursuant to point (a) of Article 34(1) or pursuant to Article 35(3), the decision on the application shall be issued after both parties have been given the opportunity to present their case, including by such appropriate means of communication technology as are available and accepted under the national law of each of the Member States involved. 4. The decision shall be issued without delay, but no later than 21 days after the court or, where national law so provides, the competent enforcement authority has received all the information necessary for its decision. The decision shall be brought to the notice of the parties. 5. The decision revoking or modifying the Preservation Order and the decision limiting or terminating the enforcement of the Preservation Order shall be enforceable immediately. Where the remedy was applied for in the Member State of origin, the court shall, in accordance with Article 29, transmit the decision on the remedy without delay to the competent authority of the Member State of enforcement, using the form established by means of implementing acts adopted in accordance with the advisory procedure referred to in Article 52(2). That authority shall, immediately upon receipt, ensure that the decision on the remedy is implemented. Where the decision on the remedy relates to a bank account maintained in the Member State of origin, it shall be implemented with respect to that bank account in accordance with the law of the Member State of origin. Where the remedy was applied for in the Member State of enforcement, the decision on the remedy shall be implemented in accordance with the law of the Member State of enforcement. Article 37 Right to appeal Either party shall have the right to appeal against a decision issued pursuant to Article 33, 34 or 35. Such an appeal shall be submitted using the appeal form established by means of implementing acts adopted in accordance with the advisory procedure referred to in Article 52(2). Article 38 Right to provide security in lieu of preservation 1. Upon application by the debtor: (a) the court that issued the Preservation Order may order the release of the funds preserved if the debtor provides to that court security in the amount of the Order, or an alternative assurance in a form acceptable under the law of the Member State in which the court is located and of a value at least equivalent to that amount; (b) the competent court or, where national law so provides, the competent enforcement authority of the Member State of enforcement may terminate the enforcement of the Preservation Order in the Member State of enforcement if the debtor provides to that court or authority security in the amount preserved in that Member State, or an alternative assurance in a form acceptable under the law of the Member State in which the court is located and of a value at least equivalent to that amount. 2. Articles 23 and 24 shall apply as appropriate to the release of the funds preserved. The provision of the security in lieu of preservation shall be brought to the notice of the creditor in accordance with national law. Article 39 Right of third parties 1. The right of a third party to contest a Preservation Order shall be governed by the law of the Member State of origin. 2. The right of a third party to contest the enforcement of a Preservation Order shall be governed by the law of the Member State of enforcement. 3. Without prejudice to other rules of jurisdiction laid down in Union law or national law, jurisdiction in respect of any action brought by a third party: (a) to contest a Preservation Order shall lie with the courts of the Member State of origin, and (b) to contest the enforcement of the Preservation Order in the Member State of enforcement shall lie with the courts of the Member State of enforcement or, where the national law of that Member State so provides, with the competent enforcement authority. CHAPTER 5 GENERAL PROVISIONS Article 40 Legalisation or other similar formality No legalisation or other similar formality shall be required in the context of this Regulation. Article 41 Legal representation Representation by a lawyer or other legal professional shall not be mandatory in proceedings to obtain a Preservation Order. In proceedings pursuant to Chapter 4, representation by a lawyer or another legal professional shall not be mandatory unless, under the law of the Member State of the court or authority with which the application for a remedy is lodged, such representation is mandatory irrespective of the nationality or domicile of the parties. Article 42 Court fees The court fees in proceedings to obtain a Preservation Order or a remedy against an Order shall not be higher than the fees for obtaining an equivalent national order or a remedy against such a national order. Article 43 Costs incurred by the banks 1. A bank shall be entitled to seek payment or reimbursement from the creditor or the debtor of the costs incurred in implementing a Preservation Order only where, under the law of the Member State of enforcement, the bank is entitled to such payment or reimbursement in relation to equivalent national orders. 2. Fees charged by a bank to cover the costs referred to in paragraph 1 shall be determined taking into account the complexity of the implementation of the Preservation Order, and may not be higher than the fees charged for the implementation of equivalent national orders. 3. Fees charged by a bank to cover the costs of providing account information pursuant to Article 14 may not be higher than the costs actually incurred and, where applicable, not higher than the fees charged for the provision of account information in the context of equivalent national orders. Article 44 Fees charged by authorities Fees charged by any authority or other body in the Member State of enforcement which is involved in the processing or enforcement of a Preservation Order, or in providing account information pursuant to Article 14, shall be determined on the basis of a scale of fees or other set of rules established in advance by each Member State and transparently setting out the applicable fees. In establishing that scale or other set of rules, a Member State may take into account the amount of the Order and the complexity involved in processing it. Where applicable, the fees may not be higher than the fees charged in connection with equivalent national orders. Article 45 Time frames Where, in exceptional circumstances, it is not possible for the court or the authority involved to respect the time frames provided for in Article 14(7), Article 18, Article 23(2), the second subparagraph of Article 25(3), Article 28(2), (3) and (6), Article 33(3) and Article 36(4) and (5), the court or authority shall take the steps required by those provisions as soon as possible. Article 46 Relationship with national procedural law 1. All procedural issues not specifically dealt with in this Regulation shall be governed by the law of the Member State in which the procedure takes place. 2. The effects of the opening of insolvency proceedings on individual enforcement actions, such as the enforcement of a Preservation Order, shall be governed by the law of the Member State in which the insolvency proceedings have been opened. Article 47 Data protection 1. Personal data which are obtained, processed or transmitted under this Regulation shall be adequate, relevant and not excessive in relation to the purpose for which they were obtained, processed or transmitted, and shall be used only for that purpose. 2. The competent authority, the information authority and any other entity responsible for enforcing the Preservation Order may not store the data referred to in paragraph 1 beyond the period necessary for the purpose for which they were obtained, processed or transmitted, which in any event shall not be longer than six months after the proceedings have ended, and shall, during that period, ensure the appropriate protection of those data. This paragraph does not apply to data processed or stored by courts in the exercise of their judicial functions. Article 48 Relationship with other instruments This Regulation is without prejudice to: (a) Regulation (EC) No 1393/2007 of the European Parliament and of the Council (14), except as provided for in Article 10(2), Article 14(3) and (6), Article 17(5), Article 23(3) and (6), Article 25(2) and (3), Article 28(1), (3), (5) and (6), Article 29, Article 33(3), Article 36(2) and (4), and Article 49(1) of this Regulation; (b) Regulation (EU) No 1215/2012; (c) Regulation (EC) No 1346/2000; (d) Directive 95/46/EC, except as provided for in Articles 14(8) and 47 of this Regulation; (e) Regulation (EC) No 1206/2001 of the European Parliament and of the Council (15); (f) Regulation (EC) No 864/2007, except as provided for in Article 13(4) of this Regulation. Article 49 Languages 1. Any documents listed in points (a) and (b) of Article 28(5) to be served on the debtor which are not in the official language of the Member State in which the debtor is domiciled or, where there are several official languages in that Member State, the official language or one of the official languages of the place where the debtor is domiciled or another language which he understands, shall be accompanied by a translation or transliteration into one of those languages. Documents listed in point (c) of Article 28(5) shall not be translated unless the court decides, exceptionally, that specific documents need to be translated or transliterated in order to enable the debtor to assert his rights. 2. Any documents to be addressed under this Regulation to a court or competent authority may also be in any other official language of the institutions of the Union, if the Member State concerned has indicated that it can accept such other language. 3. Any translation made under this Regulation shall be done by a person qualified to do translations in one of the Member States. Article 50 Information to be provided by Member States 1. By 18 July 2016, the Member States shall communicate the following information to the Commission: (a) the courts designated as competent to issue a Preservation Order (Article 6(4)); (b) the authority designated as competent to obtain account information (Article 14); (c) the methods of obtaining account information available under their national law (Article 14(5)); (d) the courts with which an appeal is to be lodged (Article 21); (e) the authority or authorities designated as competent to receive, transmit and serve the Preservation Order and other documents under this Regulation (point (14) of Article 4); (f) the authority competent to enforce the Preservation Order in accordance with Chapter 3; (g) the extent to which joint and nominee accounts can be preserved under their national law (Article 30); (h) the rules applicable to amounts exempt from seizure under national law (Article 31); (i) whether, under their national law, banks are entitled to charge fees for the implementation of equivalent national orders or for providing account information and, if so, which party is liable, provisionally and finally, to pay those fees (Article 43); (j) the scale of fees or other set of rules setting out the applicable fees charged by any authority or other body involved in the processing or enforcement of the Preservation Order (Article 44); (k) whether any ranking is conferred on equivalent national orders under national law (Article 32); (l) the courts or, where applicable, the enforcement authority, competent to grant a remedy (Article 33(1), Article 34(1) or (2)); (m) the courts with which an appeal is to be lodged, the period of time, if prescribed, within which such an appeal must be lodged under national law and the event marking the start of that period (Article 37); (n) an indication of court fees (Article 42); and (o) the languages accepted for translations of the documents (Article 49(2)). The Member States shall apprise the Commission of any subsequent changes to that information. 2. The Commission shall make the information publicly available through any appropriate means, in particular through the European Judicial Network in civil and commercial matters. Article 51 Establishment and subsequent amendment of the forms The Commission shall adopt implementing acts establishing and subsequently amending the forms referred to in Articles 8(1), 10(2), 19(1), 25(1), 27(2), 29(2) and 36(1), the second subparagraph of Article 36(5) and Article 37. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 52(2). Article 52 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 53 Monitoring and review 1. By 18 January 2022, the Commission shall submit to the European Parliament, to the Council and to the European Economic and Social Committee a report on the application of this Regulation, including an evaluation as to whether: (a) financial instruments should be included in the scope of this Regulation, and (b) amounts credited to the debtor\u2019s account after the implementation of the Preservation Order could be made subject to preservation under the Order. The report shall be accompanied, if appropriate, by a proposal to amend this Regulation and an assessment of the impact of the amendments to be introduced. 2. For the purposes of paragraph 1, the Member States shall collect and make available to the Commission upon request information on: (a) the number of applications for a Preservation Order and the number of cases in which the Order was issued; (b) the number of applications for a remedy pursuant to Articles 33 and 34 and, if possible, the number of cases in which the remedy was granted; and (c) the number of appeals lodged pursuant to Article 37 and, if possible, the number of cases in which such an appeal was successful. CHAPTER 6 FINAL PROVISIONS Article 54 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 18 January 2017, with the exception of Article 50, which shall apply from 18 July 2016. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 15 May 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 191, 29.6.2012, p. 57. (2) Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of 13 May 2014. (3) OJ C 115, 4.5.2010, p. 1. (4) Council Regulation (EC) No 1346/2000 of 29 May 2000 on insolvency proceedings (OJ L 160, 30.6.2000, p. 1). (5) Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits (OJ L 124, 8.6.1971, p. 1). (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (8) OJ C 373, 21.12.2011, p. 4. (9) Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (OJ L 166, 11.6.1998, p. 45). (10) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (11) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338). (12) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (13) Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) (OJ L 199, 31.7.2007, p. 40). (14) Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents), and repealing Council Regulation (EC) No 1348/2000 (OJ L 324, 10.12.2007, p. 79). (15) Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (OJ L 174, 27.6.2001, p. 1).", "summary": "The European Account Preservation Order for debt recovery between EU countries The European Account Preservation Order for debt recovery between EU countries SUMMARY OF: Regulation (EU) No 655/2014 \u2014 European Account Preservation Order WHAT IS THE AIM OF THE REGULATION? It aims to facilitate debt recovery between EU countries in civil and commercial matters. It establishes a new procedure allowing a court in one EU country to freeze funds in the bank account of a debtor in another EU country. KEY POINTS A European procedure is established whereby a creditor is able to obtain a European Account Preservation Order (EAPO) that blocks funds held by the debtor in a bank account or accounts in another EU country(ies). Scope The EAPO is available to citizens and businesses: in cases between EU countries, i.e. when the account, at the date of application for an EAPO, is held in an EU country other than where the creditor is domiciled or the court seized is based; as an alternative to national procedures, but does not replace them. It applies to financial claims in civil and commercial matters, excluding the following matters: revenue, customs or administrative matters and social security; rights in property arising out of marriage or equivalent relationship, and wills and succession; claims against a debtor who is the object of bankruptcy or insolvency proceedings, judicial arrangements, compositions or other similar proceedings. Some categories of specially protected bank accounts are also excluded. The EAPO is not available for creditors or bank accounts based in Denmark or the United Kingdom (1). Procedure for obtaining an EAPO The procedure is open before initiating proceedings on the substance of the matter against the debtor, during the proceedings or after obtaining a judgment, court settlement or authentic instrument requiring the debtor to pay. The court competent to issue an EAPO is normally one that is competent to rule on the substance of the matter. Where the debtor is a consumer, the court competent to issue an EAPO to secure a claim relating to the consumer\u2019s contract is the court of the EU country where the debtor is domiciled. In all cases, the creditor must provide evidence to convince the court that there is a real risk that justifies the need to freeze the debtor\u2019s account. If the creditor requests an EAPO before obtaining a judgment on the substance of the matter, sufficient evidence should also be given to the likely success of the substance of the claim. A specific form is to be used in order to apply for an EAPO, together with all supporting documents. Short time limits are set by which the different steps in the procedure must be completed; these vary depending on whether the creditor has already obtained a judgment or not. The creditor has the right to appeal against a refusal to issue an EAPO. In order to ensure the surprise effect and the usefulness of the EAPO, the debtor is not informed prior to its implementation. The creditor who does not know the debtor\u2019s account information can, under certain conditions, request the court to obtain account information from designated authorities in the EU country of enforcement. Recognition, enforceability and enforcement of the EAPO An EAPO issued in an EU country in accordance with the regulation should be recognised and enforceable in another EU country without any special procedure or declaration of enforceability. There is an obligation on the bank to declare, by means of a specific form, whether the EAPO has led to the preservation of any of the debtor\u2019s funds. The creditor has a duty to request the release of any funds preserved that exceed the amount specified in the EAPO. Some amounts may be exempt from seizure under the law of the country of enforcement, i.e. amounts necessary to ensure the livelihood of the debtor and of their family. Safeguards for the debtor In order to counterbalance the absence of a prior hearing, there are the following safeguards for the debtor against the abusive use of the EAPO: remedies \u2014 including a right of appeal \u2014 to be able to challenge the EAPO as soon as the debtor is informed of the blocking of their accounts; and rules on the provision of a security by the creditor \u2014 to ensure that the debtor can be compensated for any damage caused by the EAPO: rules on the creditor\u2019s liability for any damage caused to the debtor by the EAPO due to an error on the creditor\u2019s behalf. Forms There are nine dedicated EAPO forms in total. Their content is set out in Implementing Regulation (EU) 2016/1823. General rules The regulation also addresses various related matters, including legal representation, court fees, costs supported by the banks, fees charged by authorities, data protection and language of documents. The regulation does not affect the application of a number of related acts, such as Regulation (EC) No 1393/2007 (on the service of documents) and Regulation (EC) No 1206/2001 (on the taking of evidence). FROM WHEN DOES THE REGULATION APPLY? The regulation has applied since 18 January 2017 with the exception of its Article 50, which has applied since 18 July 2016. Article 50 relates to the information to be supplied by EU countries, such as the courts that they designate to issue (Article 6(4)) and the authorities to enforce EAPOs. BACKGROUND The regulation follows a Green Paper on improving the efficiency of enforcing judgments in the EU. In it, the European Commission described how the fragmentation of national rules on enforcement negatively affected debt collection within the EU, and observed that in practice a creditor seeking to recover a monetary claim in Europe will most commonly try to do so by taking enforcement actions against the debtor\u2019s bank account, and that such procedures exist in most EU countries. For more information, see: Justice cooperation in civil and commercial matters (European Commission). MAIN DOCUMENT Regulation (EU) No 655/2014 of the European Parliament and of the Council of 15 May 2014 establishing a European Account Preservation Order procedure to facilitate cross-border debt recovery in civil and commercial matters (OJ L 189, 27.6.2014, pp. 59-92) RELATED DOCUMENTS Commission Implementing Regulation (EU) 2016/1823 of 10 October 2016 establishing the forms referred to in Regulation (EU) No 655/2014 of the European Parliament and of the Council establishing a European Account Preservation Order procedure to facilitate cross-border debt recovery in civil and commercial matters (OJ L 283, 19.10.2016, pp. 1-48) Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents), and repealing Council Regulation (EC) No 1348/2000 (OJ L 324, 10.12.2007, pp. 79-120) Successive amendments to Regulation (EC) No 1393/2007 have been incorporated into the original document. This consolidated version is of documentary value only. Green Paper on improving the efficiency of the enforcement of judgments in the European Union: the attachment of bank accounts (COM(2006) 618 final, 24.10.2006) Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (OJ L 174, 27.6.2001, pp. 1-24) See consolidated version. last update 04.12.2017(1) The United Kingdom withdraws from the European Union and becomes a third country (non-EU country) as of 1 February 2020."}
{"article": "27.6.2014 EN Official Journal of the European Union L 189/93 REGULATION (EU) No 656/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 establishing rules for the surveillance of the external sea borders in the context of operational cooperation coordinated by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular point (d) of Article 77(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) The objective of Union policy in the field of the Union external borders is to ensure the efficient monitoring of the crossing of external borders including through border surveillance, while contributing to ensuring the protection and saving of lives. The purpose of border surveillance is to prevent unauthorised border crossings, to counter cross-border criminality and to apprehend or take other measures against those persons who have crossed the border in an irregular manner. Border surveillance should be effective in preventing and discouraging persons from circumventing the checks at border crossing points. To this end, border surveillance is not limited to the detection of attempts at unauthorised border crossings but equally extends to steps such as intercepting vessels suspected of trying to gain entry to the Union without submitting to border checks, as well as arrangements intended to address situations such as search and rescue that may arise during a border surveillance operation at sea and arrangements intended to bring such an operation to a successful conclusion. (2) The policies of the Union in border management, asylum and immigration and their implementation should be governed by the principle of solidarity and fair sharing of responsibility between the Member States pursuant to Article 80 of the Treaty on the Functioning of the European Union (TFEU). Wherever necessary, Union acts adopted in the framework of those policies are to contain appropriate measures to give effect to that principle and promote burden-sharing including through the transfer, on a voluntary basis, of beneficiaries of international protection. (3) The scope of application of this Regulation should be limited to border surveillance operations carried out by Member States at their external sea borders in the context of operational cooperation coordinated by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (\u2018the Agency\u2019) established by Council Regulation (EC) No 2007/2004 (2). Investigative and punitive measures are governed by national criminal law and the existing instruments of mutual legal assistance in the field of judicial cooperation in criminal matters in the Union. (4) The Agency is responsible for the coordination of operational cooperation between Member States in the field of management of the external borders, including as regards border surveillance. The Agency is also responsible for assisting Member States in circumstances requiring increased technical assistance at the external borders, taking into account the fact that some situations may involve humanitarian emergencies and rescue at sea. Specific rules with regard to border surveillance activities carried out by maritime, land and aerial units of one Member State at the sea border of other Member States or on the high seas in the context of operational cooperation coordinated by the Agency are necessary to further strengthen such cooperation. (5) Cooperation with neighbouring third countries is crucial to prevent unauthorised border crossings, to counter cross-border criminality and to avoid loss of life at sea. In accordance with Regulation (EC) No 2007/2004 and insofar as full respect for the fundamental rights of migrants is ensured, the Agency may cooperate with the competent authorities of third countries, in particular as regards risk analysis and training, and should facilitate operational cooperation between Member States and third countries. When cooperation with third countries takes place on the territory or the territorial sea of those countries, the Member States and the Agency should comply with norms and standards at least equivalent to those set by Union law. (6) The European Border Surveillance System (Eurosur) established by Regulation (EU) No 1052/2013 of the European Parliament and of the Council (3) aims to strengthen the information exchange and operational cooperation between Member States and with the Agency. That is to ensure that the situational awareness and reaction capability of Member States improves considerably, also with the support of the Agency, for the purposes of detecting, preventing and combating illegal immigration and cross-border crime and contributing to ensuring the protection and saving the lives of migrants at their external borders. When coordinating border surveillance operations, the Agency should provide Member States with information and analysis concerning those operations in accordance with that Regulation. (7) This Regulation replaces Council Decision 2010/252/EU (4) which was annulled by the Court of Justice of the European Union (\u2018the Court\u2019) by its judgment of 5 September 2012 in Case C-355/10. In that judgment, the Court maintained the effects of Decision 2010/252/EU until the entry into force of new rules. Therefore, as of the day of entry into force of this Regulation, that Decision ceases to produce effects. (8) During border surveillance operations at sea, Member States should respect their respective obligations under international law, in particular the United Nations Convention on the Law of the Sea, the International Convention for the Safety of Life at Sea, the International Convention on Maritime Search and Rescue, the United Nations Convention against Transnational Organized Crime and its Protocol against the Smuggling of Migrants by Land, Sea and Air, the United Nations Convention relating to the Status of Refugees, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the International Covenant on Civil and Political Rights, the United Nations Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, the United Nations Convention on the Rights of the Child and other relevant international instruments. (9) When coordinating border surveillance operations at sea, the Agency should fulfil its tasks in full compliance with relevant Union law, including the Charter of Fundamental Rights of the European Union (\u2018the Charter\u2019), and relevant international law, in particular that referred to in recital 8. (10) In accordance with Regulation (EC) No 562/2006 of the European Parliament and of the Council (5) and general principles of Union law, any measure taken in the course of a surveillance operation should be proportionate to the objectives pursued, non-discriminatory and should fully respect human dignity, fundamental rights and the rights of refugees and asylum seekers, including the principle of non-refoulement. Member States and the Agency are bound by the provisions of the asylum acquis, and in particular of Directive 2013/32/EU of the European Parliament and of the Council (6) with regard to applications for international protection made in the territory, including at the border, in the territorial waters or in the transit zones of Member States. (11) The application of this Regulation should be without prejudice to Directive 2011/36/EU of the European Parliament and the Council (7), in particular as regards assistance to be given to victims of trafficking in human beings. (12) This Regulation should be applied in full compliance with the principle of non-refoulement as defined in the Charter and as interpreted by the case-law of the Court and of the European Court of Human Rights. In accordance with that principle, no person should be disembarked in, forced to enter, conducted to or otherwise handed over to the authorities of a country where, inter alia, there is a serious risk that he or she would be subjected to the death penalty, torture, persecution or other inhuman or degrading treatment or punishment, or where his or her life or freedom would be threatened on account of his or her race, religion, nationality, sexual orientation, membership of a particular social group or political opinion, or from which there is a serious risk of an expulsion, removal or extradition to another country in contravention of the principle of non-refoulement. (13) The possible existence of an arrangement between a Member State and a third country does not absolve Member States from their obligations under Union and international law, in particular as regards compliance with the principle of non-refoulement, whenever they are aware or ought to be aware that systemic deficiencies in the asylum procedure and in the reception conditions of asylum seekers in that third country amount to substantial grounds for believing that the asylum seeker would face a serious risk of being subjected to inhuman or degrading treatment or where they are aware or ought to be aware that that third country engages in practices in contravention of the principle of non-refoulement. (14) During a border surveillance operation at sea, a situation may occur where it will be necessary to render assistance to persons found in distress. In accordance with international law, every State must require the master of a vessel flying its flag, in so far as he can do so without serious danger to the vessel, the crew or the passengers, to render assistance without delay to any person found at sea in danger of being lost and to proceed with all possible speed to the rescue of persons in distress. Such assistance should be provided regardless of the nationality or status of the persons to be assisted or of the circumstances in which they are found. The shipmaster and crew should not face criminal penalties for the sole reason of having rescued persons in distress at sea and brought them to a place of safety. (15) The obligation to render assistance to persons found in distress should be fulfilled by Member States in accordance with the applicable provisions of international instruments governing search and rescue situations and in accordance with requirements concerning the protection of fundamental rights. This Regulation should not affect the responsibilities of search and rescue authorities, including for ensuring that coordination and cooperation is conducted in such a way that the persons rescued can be delivered to a place of safety. (16) When the operational area of a sea operation includes the search and rescue region of a third country, the establishment of communication channels with the search and rescue authorities of that third country should be sought when planning a sea operation, thereby ensuring that those authorities will be able to respond to search and rescue cases developing within their search and rescue region. (17) Pursuant to Regulation (EC) No 2007/2004, border surveillance operations coordinated by the Agency are conducted in accordance with an operational plan. Accordingly, as regards sea operations, the operational plan should include specific information on the application of the relevant jurisdiction and legislation in the geographical area where the joint operation, pilot project or rapid intervention takes place, including references to Union and international law regarding interception, rescue at sea and disembarkation. The operational plan should be established in accordance with the provisions of this Regulation governing interception, rescue at sea and disembarkation in the context of border surveillance operations at sea coordinated by the Agency and having regard to the particular circumstances of the operation concerned. The operational plan should include procedures ensuring that persons with international protection needs, victims of trafficking in human beings, unaccompanied minors and other vulnerable persons are identified and provided with appropriate assistance, including access to international protection. (18) The practice under Regulation (EC) No 2007/2004 is that for each sea operation, a coordination structure is established within the host Member State, composed of officers from the host Member State, guest officers and representatives of the Agency, including the Coordinating Officer of the Agency. This coordination structure, usually called International Coordination Centre, should be used as a channel for communication between the officers involved in the sea operation and the authorities concerned. (19) This Regulation respects the fundamental rights and observes the principles recognised by Articles 2 and 6 of the Treaty on European Union (TEU) and by the Charter, in particular respect for human dignity, the right to life, the prohibition of torture and of inhuman or degrading treatment or punishment, the prohibition of trafficking in human beings, the right to liberty and security, the right to the protection of personal data, the right to asylum and to protection against removal and expulsion, the principles of non-refoulement and non-discrimination, the right to an effective remedy and the rights of the child. This Regulation should be applied by Member States and the Agency in accordance with those rights and principles. (20) Since the objective of this Regulation, namely to adopt specific rules for the surveillance of the sea borders by border guards operating under the coordination of the Agency, cannot be sufficiently achieved by the Member States due to the differences in their laws and practices, but can rather, by reason of the multinational character of the operations, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (21) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (22) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters\u2019 association with the implementation, application and development of the Schengen acquis (8) which fall within the area referred to in Article 1, point A, of Council Decision 1999/437/EC (9). (23) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (10) which fall within the area referred to in Article 1, point A, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (11). (24) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (12), which fall within the area referred to in Article 1, point A, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (13). (25) This Regulation constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (14); the United Kingdom is therefore not taking part in its adoption and is not bound by it or subject to its application. (26) This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (15); Ireland is therefore not taking part in its adoption and is not bound by it or subject to its application, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Scope This Regulation shall apply to border surveillance operations carried out by Member States at their external sea borders in the context of operational cooperation coordinated by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union. Article 2 Definitions For the purposes of this Regulation the following definitions shall apply: (1) \u2018Agency\u2019 means the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union established by Regulation (EC) No 2007/2004; (2) \u2018sea operation\u2019 means a joint operation, pilot project or rapid intervention carried out by Member States for the surveillance of their external sea borders under the coordination of the Agency; (3) \u2018host Member State\u2019 means a Member State in which a sea operation takes place or from which it is launched; (4) \u2018participating Member State\u2019 means a Member State which participates in a sea operation by providing technical equipment, border guards deployed as part of the European Border Guard Teams or other relevant staff but which is not a host Member State; (5) \u2018participating unit\u2019 means a maritime, land or aerial unit under the responsibility of the host Member State or of a participating Member State that takes part in a sea operation; (6) \u2018International Coordination Centre\u2019 means the coordination structure established within the host Member State for the coordination of a sea operation; (7) \u2018National Coordination Centre\u2019 means the national coordination centre established for the purposes of the European Border Surveillance System (Eurosur) in accordance with Regulation (EU) No 1052/2013; (8) \u2018operational plan\u2019 means the operational plan referred to in Article 3a and Article 8e of Regulation (EC) No 2007/2004; (9) \u2018vessel\u2019 means any type of water craft, including boats, dinghies, floating platforms, non-displacement craft and seaplanes, used or capable of being used at sea; (10) \u2018stateless vessel\u2019 means a vessel without nationality or assimilated to a vessel without nationality when the vessel has not been granted by any State the right to fly its flag or when it sails under the flags of two or more States, using them according to convenience; (11) \u2018Protocol against the Smuggling of Migrants\u2019 means the Protocol against the Smuggling of Migrants by Land, Sea and Air, supplementing the United Nations Convention against Transnational Organised Crime signed in Palermo, Italy in December 2000; (12) \u2018place of safety\u2019 means a location where rescue operations are considered to terminate and where the survivors\u2019 safety of life is not threatened, where their basic human needs can be met and from which transportation arrangements can be made for the survivors\u2019 next destination or final destination, taking into account the protection of their fundamental rights in compliance with the principle of non-refoulement; (13) \u2018Rescue Coordination Centre\u2019 means a unit responsible for promoting efficient organisation of search and rescue services and for coordinating the conduct of search and rescue operations within a search and rescue region as defined in the International Convention on Maritime Search and Rescue; (14) \u2018contiguous zone\u2019 means a zone contiguous to the territorial sea as defined in Article 33 of the United Nations Convention on the Law of the Sea, where formally proclaimed; (15) \u2018coastal Member State\u2019 means a Member State in whose territorial sea or contiguous zone an interception takes place. CHAPTER II GENERAL RULES Article 3 Safety at sea Measures taken for the purpose of a sea operation shall be conducted in a way that, in all instances, ensures the safety of the persons intercepted or rescued, the safety of the participating units or that of third parties. Article 4 Protection of fundamental rights and the principle of non-refoulement 1. No person shall, in contravention of the principle of non-refoulement, be disembarked in, forced to enter, conducted to or otherwise handed over to the authorities of a country where, inter alia, there is a serious risk that he or she would be subjected to the death penalty, torture, persecution or other inhuman or degrading treatment or punishment, or where his or her life or freedom would be threatened on account of his or her race, religion, nationality, sexual orientation, membership of a particular social group or political opinion, or from which there is a serious risk of an expulsion, removal or extradition to another country in contravention of the principle of non-refoulement. 2. When considering the possibility of disembarkation in a third country, in the context of planning a sea operation, the host Member State, in coordination with participating Member States and the Agency, shall take into account the general situation in that third country. The assessment of the general situation in a third country shall be based on information derived from a broad range of sources, which may include other Member States, Union bodies, offices and agencies, and relevant international organisations and it may take into account the existence of agreements and projects on migration and asylum carried out in accordance with Union law and through Union funds. That assessment shall be part of the operational plan, shall be provided to the participating units and shall be updated as necessary. Intercepted or rescued persons shall not be disembarked, forced to enter, conducted to or otherwise handed over to the authorities of a third country when the host Member State or the participating Member States are aware or ought to be aware that that third country engages in practices as described in paragraph 1. 3. During a sea operation, before the intercepted or rescued persons are disembarked in, forced to enter, conducted to or otherwise handed over to the authorities of a third country and taking into account the assessment of the general situation in that third country in accordance with paragraph 2, the participating units shall, without prejudice to Article 3, use all means to identify the intercepted or rescued persons, assess their personal circumstances, inform them of their destination in a way that those persons understand or may reasonably be presumed to understand and give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be in violation of the principle of non-refoulement. For those purposes, further details shall be provided for in the operational plan including, when necessary, the availability of shore-based medical staff, interpreters, legal advisers and other relevant experts of the host and participating Member States. Each participating unit shall include at least one person with basic first aid training. The report referred to in Article 13 shall, based on information that shall be provided by the host and participating Member States, include further details on cases of disembarkation in third countries and how each element of the procedures laid down in the first subparagraph of this paragraph was applied by the participating units to ensure compliance with the principle of non-refoulement. 4. Throughout a sea operation, the participating units shall address the special needs of children, including unaccompanied minors, victims of trafficking in human beings, persons in need of urgent medical assistance, disabled persons, persons in need of international protection and other persons in a particularly vulnerable situation. 5. Any exchange with third countries of personal data obtained during a sea operation for the purposes of this Regulation shall be strictly limited to what is absolutely necessary and shall be carried out in accordance with Directive 95/46/EC of the European Parliament and of the Council (16), Council Framework Decision 2008/977/JHA (17) and relevant national provisions on data protection. The exchange with third countries of personal data regarding intercepted or rescued persons obtained during a sea operation shall be prohibited where there is a serious risk of contravention of the principle of non-refoulement. 6. Participating units shall, in the performance of their duties, fully respect human dignity. 7. This Article shall apply to all measures taken by Member States or the Agency in accordance with this Regulation. 8. Border guards and other staff participating in a sea operation shall be trained with regard to relevant provisions of fundamental rights, refugee law and the international legal regime of search and rescue in accordance with the second paragraph of Article 5 of Regulation (EC) No 2007/2004. CHAPTER III SPECIFIC RULES Article 5 Detection 1. Upon detection, the participating units shall approach a vessel suspected of carrying persons circumventing or intending to circumvent checks at border crossing points or of being engaged in the smuggling of migrants by sea in order to observe its identity and nationality and, pending further measures, shall survey that vessel at a prudent distance taking all due precautions. The participating units shall collect and immediately report information about that vessel to the International Coordination Centre, including, where possible, information about the situation of persons on board, in particular whether there is an imminent risk to their lives or whether there are persons in urgent need of medical assistance. The International Coordination Centre shall transmit that information to the National Coordination Centre of the host Member State. 2. Where a vessel is about to enter or it has entered the territorial sea or the contiguous zone of a Member State that is not participating in the sea operation, the participating units shall collect and report information about that vessel to the International Coordination Centre, which shall transmit that information to the National Coordination Centre of the Member State concerned. 3. The participating units shall collect and report information about any vessel suspected of being engaged in illegal activities at sea, which are outside the scope of the sea operation, to the International Coordination Centre, which shall transmit that information to the National Coordination Centre of the Member State concerned. Article 6 Interception in the territorial sea 1. In the territorial sea of the host Member State or a neighbouring participating Member State, that State shall authorise the participating units to take one or more of the following measures where there are reasonable grounds to suspect that a vessel may be carrying persons intending to circumvent checks at border crossing points or is engaged in the smuggling of migrants by sea: (a) requesting information and documentation on ownership, registration and elements relating to the voyage of the vessel, and on the identity, nationality and other relevant data on persons on board, including whether there are persons in urgent need of medical assistance, and making persons on board aware that they may not be authorised to cross the border; (b) stopping, boarding and searching the vessel, its cargo and persons on board, and questioning persons on board and informing them that persons directing the vessel may face penalties for facilitating the voyage. 2. If evidence confirming that suspicion is found, that host Member State or neighbouring participating Member State may authorise the participating units to take one or more of the following measures: (a) seizing the vessel and apprehending persons on board; (b) ordering the vessel to alter its course outside of or towards a destination other than the territorial sea or the contiguous zone, including escorting the vessel or steaming nearby until it is confirmed that the vessel is keeping to that given course; (c) conducting the vessel or persons on board to the coastal Member State in accordance with the operational plan. 3. Any measure taken in accordance with paragraph 1 or 2 shall be proportionate and shall not exceed what is necessary to achieve the objectives of this Article. 4. For the purposes of paragraphs 1 and 2, the host Member State shall instruct the participating unit appropriately through the International Coordination Centre. The participating unit shall inform the host Member State, through the International Coordination Centre, whenever the master of the vessel requests that a diplomatic agent or a consular officer of the flag State be notified. 5. Where there are reasonable grounds to suspect that a stateless vessel is carrying persons intending to circumvent the checks at border crossing points or is engaged in the smuggling of migrants by sea, the host Member State or the neighbouring participating Member State in whose territorial sea that stateless vessel is intercepted shall authorise one or more of the measures laid down in paragraph 1 and may authorise one or more of the measures laid down in paragraph 2. The host Member State shall instruct the participating unit appropriately through the International Coordination Centre. 6. Any operational activities in the territorial sea of a Member State that is not participating in the sea operation shall be conducted in accordance with the authorisation of that Member State. The host Member State shall instruct the participating unit through the International Coordination Centre based on the course of action authorised by that Member State. Article 7 Interception on the high seas 1. On the high seas, where there are reasonable grounds to suspect that a vessel is engaged in the smuggling of migrants by sea, the participating units shall take one or more of the following measures, subject to the authorisation of the flag State, in accordance with the Protocol against the Smuggling of Migrants, and where relevant, national and international law: (a) requesting information and documentation on ownership, registration and elements relating to the voyage of the vessel, and on the identity, nationality and other relevant data on persons on board, including whether there are persons in urgent need of medical assistance; (b) stopping, boarding and searching the vessel, its cargo and persons on board, and questioning persons on board and informing them that persons directing the vessel may face penalties for facilitating the voyage. 2. If evidence confirming that suspicion is found, the participating units may take one or more of the following measures, subject to the authorisation of the flag State, in accordance with the Protocol against the Smuggling of Migrants, and where relevant, national and international law: (a) seizing the vessel and apprehending persons on board; (b) warning and ordering the vessel not to enter the territorial sea or the contiguous zone, and, where necessary, requesting the vessel to alter its course towards a destination other than the territorial sea or the contiguous zone; (c) conducting the vessel or persons on board to a third country or otherwise handing over the vessel or persons on board to the authorities of a third country; (d) conducting the vessel or persons on board to the host Member State or to a neighbouring participating Member State. 3. Any measure taken in accordance with paragraph 1 or 2 shall be proportionate and shall not exceed what is necessary to achieve the objectives of this Article. 4. For the purposes of paragraphs 1 and 2, the host Member State shall instruct the participating unit appropriately through the International Coordination Centre. 5. Where the vessel is flying the flag or displays the marks of registry of the host Member State or of a participating Member State, that Member State may, after confirming the nationality of the vessel, authorise one or more of the measures laid down in paragraphs 1 and 2. The host Member State shall then instruct the participating unit appropriately through the International Coordination Centre. 6. Where the vessel is flying the flag or displays the marks of registry of a Member State that is not participating in the sea operation or of a third country, the host Member State or a participating Member State, depending on whose participating unit has intercepted that vessel, shall notify the flag State, shall request confirmation of registry and, if nationality is confirmed, shall request that the flag State take action to suppress the use of its vessel for smuggling of migrants. If the flag State is unwilling or unable to do so either directly or with the assistance of the Member State to whom the participating unit belongs, that Member State shall request authorisation from the flag State to take any of the measures laid down in paragraphs 1 and 2. The host Member State or the participating Member State shall inform the International Coordination Centre of any communication with the flag State and of the intended actions or measures authorised by the flag State. The host Member State shall then instruct the participating unit appropriately through the International Coordination Centre. 7. Where, though flying a foreign flag or refusing to show its flag, there are reasonable grounds to suspect that the vessel is, in reality, of the same nationality as a participating unit, that participating unit shall verify the vessel\u2019s right to fly its flag. To that end, it may approach the suspect vessel. If suspicion remains, it shall proceed to a further examination on board the vessel, which shall be carried out with all possible consideration. 8. Where, though flying a foreign flag or refusing to show its flag, there are reasonable grounds to suspect that the vessel is, in reality, of the nationality of the host Member State or a participating Member State, the participating unit shall verify the vessel\u2019s right to fly its flag. 9. Where, in the cases referred to in paragraph 7 or 8, the suspicions regarding the nationality of the vessel prove to be founded, that host Member State or that participating Member State may authorise one or more of the measures laid down in paragraphs 1 and 2. The host Member State shall then instruct the participating unit appropriately through the International Coordination Centre. 10. Pending or in the absence of authorisation of the flag State, the vessel shall be surveyed at a prudent distance. No other measures shall be taken without the express authorisation of the flag State, except those necessary to relieve imminent danger to the lives of persons or those measures which derive from relevant bilateral or multilateral agreements. 11. Where there are reasonable grounds to suspect that a stateless vessel is engaged in the smuggling of migrants by sea, the participating unit may board and search the vessel with a view to verifying its statelessness. If evidence confirming that suspicion is found, the participating unit shall inform the host Member State which may take, directly or with the assistance of the Member State to whom the participating unit belongs, further appropriate measures as laid down in paragraphs 1 and 2 in accordance with national and international law. 12. A Member State whose participating unit has taken any measure in accordance with paragraph 1 shall promptly inform the flag State of the outcome of that measure. 13. The national official representing the host Member State or a participating Member State at the International Coordination Centre shall be responsible for facilitating communications with the relevant authorities of that Member State in seeking authorisation to verify the right of a vessel to fly its flag or to take any of the measures laid down in paragraphs 1 and 2. 14. Where the grounds to suspect that a vessel is engaged in the smuggling of migrants on the high seas prove to be unfounded or where the participating unit does not have jurisdiction to act, but there remains a reasonable suspicion that the vessel is carrying persons intending to reach the border of a Member State and to circumvent checks at border crossing points, that vessel shall continue to be monitored. The International Coordination Centre shall communicate information about that vessel to the National Coordination Centre of the Member States towards which it is directed. Article 8 Interception in the contiguous zone 1. In the contiguous zone of the host Member State or of a neighbouring participating Member State, the measures laid down in paragraphs 1 and 2 of Article 6 shall be taken in accordance with those paragraphs and with paragraphs 3 and 4 thereof. Any authorisation referred to in Article 6(1) and (2) may only be given for measures that are necessary to prevent the infringement of relevant laws and regulations within that Member State\u2019s territory or territorial sea. 2. The measures laid down in Article 6(1) and (2) shall not be taken in the contiguous zone of a Member State that is not participating in the sea operation without the authorisation of that Member State. The International Coordination Centre shall be informed of any communication with that Member State and of the subsequent course of action authorised by that Member State. If that Member State does not give its authorisation and where there are reasonable grounds to suspect that the vessel is carrying persons intending to reach the border of a Member State, Article 7(14) shall apply. 3. Where a stateless vessel is transiting the contiguous zone, Article 7(11) shall apply. Article 9 Search and rescue situations 1. Member States shall observe their obligation to render assistance to any vessel or person in distress at sea and, during a sea operation, they shall ensure that their participating units comply with that obligation, in accordance with international law and respect for fundamental rights. They shall do so regardless of the nationality or status of such a person or the circumstances in which that person is found. 2. For the purpose of dealing with search and rescue situations that may occur during a sea operation, the operational plan shall contain, in accordance with relevant international law, including that on search and rescue, at least the following provisions: (a) When, in the course of a sea operation, the participating units have reason to believe that they are facing a phase of uncertainty, alert or distress as regards a vessel or any person on board, they shall promptly transmit all available information to the Rescue Coordination Centre responsible for the search and rescue region in which the situation occurs and they shall place themselves at the disposal of that Rescue Coordination Centre. (b) The participating units shall inform the International Coordination Centre as soon as possible of any contact with the Rescue Coordination Centre and of the course of action taken by them. (c) A vessel or the persons on board shall be considered to be in a phase of uncertainty in particular: (i) when a person has been reported as missing or a vessel is overdue; or (ii) when a person or a vessel has failed to make an expected position or safety report. (d) A vessel or the persons on board shall be considered to be in a phase of alert in particular: (i) when, following a phase of uncertainty, attempts to establish contact with a person or a vessel have failed and inquiries addressed to other appropriate sources have been unsuccessful; or (ii) when information has been received indicating that the operating efficiency of a vessel is impaired, but not to the extent that a distress situation is likely. (e) A vessel or the persons on board shall be considered to be in a phase of distress in particular: (i) when positive information is received that a person or a vessel is in danger and in need of immediate assistance; or (ii) when, following a phase of alert, further unsuccessful attempts to establish contact with a person or a vessel and more widespread unsuccessful inquiries point to the probability that a distress situation exists; or (iii) when information is received which indicates that the operating efficiency of a vessel has been impaired to the extent that a distress situation is likely. (f) Participating units shall, for the purpose of considering whether the vessel is in a phase of uncertainty, alert or distress, take into account and transmit all relevant information and observations to the responsible Rescue Coordination Centre including on: (i) the existence of a request for assistance, although such a request shall not be the sole factor for determining the existence of a distress situation; (ii) the seaworthiness of the vessel and the likelihood that the vessel will not reach its final destination; (iii) the number of persons on board in relation to the type and condition of the vessel; (iv) the availability of necessary supplies such as fuel, water and food to reach a shore; (v) the presence of qualified crew and command of the vessel; (vi) the availability and capability of safety, navigation and communication equipment; (vii) the presence of persons on board in urgent need of medical assistance; (viii) the presence of deceased persons on board; (ix) the presence of pregnant women or of children on board; (x) the weather and sea conditions, including weather and marine forecasts. (g) While awaiting instructions from the Rescue Coordination Centre, participating units shall take all appropriate measures to ensure the safety of the persons concerned. (h) Where a vessel is considered to be in a situation of uncertainty, alert or distress but the persons on board refuse to accept assistance, the participating unit shall inform the responsible Rescue Coordination Centre and follow its instructions. The participating unit shall continue to fulfil a duty of care by surveying the vessel and by taking any measure necessary for the safety of the persons concerned, while avoiding to take any action that might aggravate the situation or increase the chances of injury or loss of life. (i) Where the Rescue Coordination Centre of a third country responsible for the search and rescue region does not respond to the information transmitted by the participating unit, the latter shall contact the Rescue Coordination Centre of the host Member State unless that participating unit considers that another internationally recognised Rescue Coordination Centre is better able to assume coordination of the search and rescue situation. The operational plan may contain details adapted to the circumstances of the sea operation concerned. 3. Where the search and rescue situation has been concluded, the participating unit shall, in consultation with the International Coordination Centre, resume the sea operation. Article 10 Disembarkation 1. The operational plan shall contain, in accordance with international law and respect for fundamental rights, at least the following modalities for the disembarkation of the persons intercepted or rescued in a sea operation: (a) in the case of interception in the territorial sea or the contiguous zone as laid down in Article 6(1), (2) or (6) or in Article 8(1) or (2), disembarkation shall take place in the coastal Member State, without prejudice to point (b) of Article 6(2); (b) in the case of interception on the high seas as laid down in Article 7, disembarkation may take place in the third country from which the vessel is assumed to have departed. If that is not possible, disembarkation shall take place in the host Member State; (c) in the case of search and rescue situations as laid down in Article 9 and without prejudice to the responsibility of the Rescue Coordination Centre, the host Member State and the participating Member States shall cooperate with the responsible Rescue Coordination Centre to identify a place of safety and, when the responsible Rescue Coordination Centre designates such a place of safety, they shall ensure that disembarkation of the rescued persons is carried out rapidly and effectively. If it is not possible to arrange for the participating unit to be released of its obligation referred to in Article 9(1) as soon as reasonably practicable, taking into account the safety of the rescued persons and that of the participating unit itself, it shall be authorised to disembark the rescued persons in the host Member State. Those modalities for disembarkation shall not have the effect of imposing obligations on Member States not participating in the sea operation unless they expressly provide authorisation for measures to be taken in their territorial sea or contiguous zone in accordance with Article 6(6) or Article 8(2). The operational plan may contain details adapted to the circumstances of the sea operation concerned. 2. The participating units shall inform the International Coordination Centre of the presence of any persons within the meaning of Article 4, and the International Coordination Centre shall transmit that information to the competent national authorities of the country where disembarkation takes place. The operational plan shall contain the contact details of those competent national authorities, which shall take appropriate follow-up measures. Article 11 Amendment to Regulation (EC) No 2007/2004 In Articles 3a(1) and 8e(1) of Regulation (EC) No 2007/2004, at the end of point (j) respectively, the following sentence is added: \u2018In that regard the operational plan shall be established in accordance with Regulation (EU) No 656/2014 of the European Parliament and of the Council (18). Article 12 Solidarity mechanisms 1. A Member State faced with a situation of urgent and exceptional pressure at its external border shall be able to request: (a) the deployment of European Border Guard Teams in accordance with Article 8a of Regulation (EC) No 2007/2004 to provide rapid operational assistance to that Member State; (b) the Agency for technical and operational assistance in accordance with Article 8 of Regulation (EC) No 2007/2004 in order to obtain assistance on matters of coordination between Members States and/or the deployment of experts to support the competent national authorities; (c) emergency assistance under Article 14 of Regulation (EU) No 515/2014 of the European Parliament and of the Council (19) to address urgent and specific needs in the event of an emergency situation. 2. A Member State subject to strong migratory pressure which places urgent demands on its reception facilities and asylum systems shall be able to request: (a) the European Asylum Support Office for the deployment of an asylum support team in accordance with Article 13 of Regulation (EU) No 439/2010 of the European Parliament and of the Council (20) to provide expertise, such as in relation to interpreting services, information on countries of origin and knowledge of the handling and management of asylum cases; (b) emergency assistance under Article 21 of Regulation (EU) No 516/2014 of the European Parliament and of the Council (21) to address urgent and specific needs in the event of an emergency situation. Article 13 Report 1. The Agency shall submit a report to the European Parliament, the Council and the Commission on the practical application of this Regulation by 18 July 2015 and every year thereafter. 2. The report shall include a description of the procedures put in place by the Agency to apply this Regulation during sea operations and information on the application of this Regulation in practice, including detailed information on compliance with fundamental rights and the impact on those rights, and any incidents which may have taken place. CHAPTER IV FINAL PROVISIONS Article 14 Effects of Decision 2010/252/EU Decision 2010/252/EU ceases to produce effects from the date of entry into force of this Regulation. Article 15 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 15 May 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) Position of the European Parliament of 16 April 2014 (not yet published in the Official Journal) and decision of the Council of 13 May 2014. (2) Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 349, 25.11.2004, p. 1). (3) Regulation (EU) No 1052/2013 of the European Parliament and of the Council of 22 October 2013 establishing the European Border Surveillance System (Eurosur) (OJ L 295, 6.11.2013, p. 11). (4) Council Decision 2010/252/EU of 26 April 2010 supplementing the Schengen Borders Code as regards the surveillance of the sea external borders in the context of operational cooperation coordinated by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 111, 4.5.2010, p. 20). (5) Regulation (EC) No 562/2006 of the European Parliament and of the Council of 15 March 2006 establishing a Community Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 105, 13.4.2006, p. 1). (6) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60). (7) Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, and replacing Council Framework Decision 2002/629/JHA (OJ L 101, 15.4.2011, p. 1). (8) OJ L 176, 10.7.1999, p. 36. (9) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (10) OJ L 53, 27.2.2008, p. 52. (11) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (12) OJ L 160, 18.6.2011, p. 21. (13) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (14) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (15) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland\u2019s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (16) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (17) Council Framework Decision 2008/977/JHA of 27 November 2008 on the protection of personal data processed in the framework of police and judicial cooperation in criminal matters (OJ L 350, 30.12.2008, p. 60). (19) Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (OJ L 150, 20.5.2014, p. 143). (20) Regulation (EU) No 439/2010 of the European Parliament and of the Council of 19 May 2010 establishing a European Asylum Support Office (OJ L 132, 29.5.2010, p. 11). (21) Regulation (EU) No 516/2014 of the European Parliament and of the Council of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC (OJ L 150, 20.5.2014, p. 168).", "summary": "Controlling the EU external maritime borders and saving immigrants\u2019 lives in operations at sea Controlling the EU external maritime borders and saving immigrants\u2019 lives in operations at sea This regulation sets out the rules for the monitoring of the European Union\u2019s sea borders, the interception of vessels suspected of carrying irregular immigrants and the rescue of those in danger at sea in border surveillance operations under the coordination of Frontex. ACT Regulation (EU) No 656/2014 of the European Parliament and of the Council of 15 May 2014 establishing rules for the surveillance of the external sea borders in the context of operational cooperation coordinated by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union. SUMMARY The objective of the European Union's external maritime borders policy is to ensure the efficient monitoring of the crossing external borders so as to counter irregular immigration and cross-border crime, while protecting and saving lives at sea. To this end, sea operations under the supervision of Frontex (the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union) are envisaged to: detect unauthorised attempts to cross external borders; intercept vessels suspected of trying to enter the European Union without submitting to border checks and carrying irregular immigrants; address situations such as search and rescue that may arise during a border surveillance operation at sea; guarantee the protection of immigrants\u2019 fundamental rights and prevent their expulsion to a country where they might be subject to persecution or danger of death (the principle of non-refoulement). INTERCEPTION OF VESSELS Specific rules are set out in case of detection of vessels with irregular immigrants on board depending on where the vessels are intercepted (in territorial sea, contiguous zones or high seas). EU countries are able to seize the vessel, apprehend the persons on board and lead the vessel to a coastal country, the host EU country or to a non EU- country provided that this does not put them in danger. Other rules are set out to manage search and rescue situations to offer assistance to persons in distress at sea and disembark the people who are rescued. During an operation at sea, assistance must be provided regardless of the nationality or status of the persons to be assisted and in accordance with the relevant international law. FRONTEX OPERATIONAL PLAN Border surveillance operations are carried out by EU countries with the operational support of Frontex. The agency is responsible for: coordinating operational cooperation between EU countries; providing increased technical and operational assistance in case of humanitarian emergencies and rescue at sea. To this end, an operational plan is prepared containing details adapted to the circumstances of the planned operation at sea. In particular, operational plans must ensure that children and vulnerable persons are provided with appropriate assistance. Solidarity mechanisms EU countries subject to strong migratory pressure may request specific help and support from the European Asylum Support Office and the deployment of European Border Guard Teams, in case of an emergency situation. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 656/2014 17.7.2014 - OJ L 189 of 27.6.2014. last update 28.09.2014"}
{"article": "20.5.2014 EN Official Journal of the European Union L 150/112 REGULATION (EU) No 514/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 78(2), Article 79(2) and (4), Article 82(1), Article 84 and Article 87(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Union\u2019s home affairs policy is to create an area of freedom, security and justice: an area without internal borders where people may enter, move, live and work freely, confident that their rights are fully respected and their security assured, bearing in mind common challenges such as the development of a comprehensive Union immigration policy to enhance the competitiveness and social cohesion of the Union, the creation of a Common European Asylum System, the prevention of threats of serious and organised crime, and the fight against illegal immigration, human trafficking, cybercrime and terrorism. (2) It is necessary to adopt an integrated approach to questions arising from the pressure of migration and asylum applications and regarding the management of the external borders of the Union, ensuring full respect for international and human rights law, including as regards actions implemented in third countries, showing solidarity amongst all Member States and demonstrating an awareness of the need to respect national responsibilities in the process of ensuring a clear definition of tasks. (3) Union funding to support the development of the area of freedom, security and justice should bring added value for the Union and constitute a tangible sign of the solidarity and responsibility-sharing which are indispensable in responding to the common challenges. (4) The existence of a common framework should ensure the necessary coherence, simplification and uniform implementation of that funding across the policy areas concerned. (5) The spending of funds in that area should be coordinated in order to assure complementarity, efficiency and visibility, as well as to achieve budgetary synergies. (6) A common framework should lay down the principles of assistance and identify the responsibilities of the Member States and the Commission in ensuring the application of those principles, including the prevention and detection of irregularities and fraud. (7) Such Union funding would be more efficient and better targeted if co-financing of eligible actions were based on strategic multiannual programming, drawn up by each Member State in dialogue with the Commission. (8) Measures in and in relation to third countries supported through the Specific Regulations as defined in this Regulation (\u2018Specific Regulations\u2019) should be taken in synergy and coherence with other actions outside the Union supported through Union external assistance instruments, both geographic and thematic. In particular, in implementing such actions, full coherence should be sought with the principles and general objectives of the Union\u2019s external action and foreign policy related to the country or region in question. Those measures should not be intended to support actions that are directly oriented towards development and they should complement, when appropriate, the financial assistance provided through external aid instruments. The principle of policy coherence for development, as set out in paragraph 35 of the European consensus on Development, should be respected. It is also important to ensure that the implementation of emergency assistance is consistent with, and, where relevant, complementary to the Union humanitarian policy and respects humanitarian principles as set out in the European Consensus on Humanitarian Aid. (9) External action should be consistent and coherent, as set out in Article 18(4) of the Treaty on European Union (TEU). (10) Prior to the preparation of multiannual programmes as a means of achieving the objectives of such Union funding, Member States and the Commission should engage in a policy dialogue and thereby establish a coherent strategy for each individual Member State. Following the completion of the policy dialogue, each Member State should submit to the Commission a national programme describing how it aims to achieve the objectives of the relevant Specific Regulation for the period 2014-20. The Commission should examine whether the national programme is consistent with those objectives and with the outcome of the policy dialogue. Moreover, the Commission should examine whether the distribution of Union funding between the objectives complies with the minimum percentage set per objective in the relevant Specific Regulation. It should be possible for Member States to depart from those minimum percentages, in which case they should state the reasons for the deviation in their national programme. In the event that the reasons given by the Member State concerned were not deemed adequate, the Commission might not approve the national programme. The Commission should regularly inform the European Parliament of the outcome of the policy dialogues, of the full programming process including the preparation of national programmes, covering also compliance with the minimum percentage set per objective in the relevant Specific Regulations as defined in this Regulation, and of the implementation of the national programmes. (11) The strategy should be subject to a mid-term review, to ensure appropriate funding in the period 2018-20. (12) Member States should establish, in a manner consistent with the principle of proportionality and the need to minimise administrative burden, a partnership with the authorities and bodies concerned to develop and implement their national programmes throughout the entire multiannual period. Member States should ensure that there is no conflict of interest among the partners at the different stages of the programming cycle. Each Member State should set up a committee to monitor the national programme and assist it in reviewing the implementation and the progress made in achieving the programme objectives. Each Member State should be responsible for establishing the practical arrangements for setting up the monitoring committee. (13) Eligibility of expenditure under the national programmes should be determined by national law, subject to common principles set out in this Regulation. The starting and closing dates for the eligibility of expenditure should be defined so as to provide for uniform and equitable rules applying to the national programmes. (14) Technical assistance should enable the Member States to support the implementation of their national programmes and assist beneficiaries in complying with their obligations and Union law. Where appropriate, technical assistance could cover the costs incurred by the competent authorities in third countries. (15) To ensure an adequate framework for providing rapidly emergency assistance, this Regulation should allow support for actions the expenditure of which was incurred before the application for such assistance was made, but not before 1 January 2014, in accordance with the provision in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (4), which allows such flexibility in duly substantiated exceptional cases. The support may constitute 100 % of the eligible expenditure in duly justified cases where this is essential for the action to be carried out, particularly where the beneficiary is an international or non-governmental organisation. Actions supported with emergency assistance should arise directly from the emergency situation and should not replace long-term investments by Member States. (16) The decisions taken relevant to the contribution from the Union budget should be properly documented to maintain an adequate audit trail. (17) The financial interests of the Union should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) No 966/2012. (18) In the context of the protection of the financial interests of the Union, the on-the-spot checks and audits carried out by the Member States, the Commission, the Court of Auditors and the European Anti-Fraud Office established by Commission Decision 1999/352/EC, ECSC, Euratom (5) (\u2018OLAF\u2019) can be announced as well as unannounced, in accordance with the applicable law. (19) The new structure of the funding in the field of home affairs aims to simplify the applicable rules and to reduce the administrative burden for the beneficiaries. Nevertheless, the control mechanism should remain efficient, and therefore it is important to recall the applicable rules on the protection of the financial interests of the Union, providing for on-the-spot checks and audits which may be announced as well as unannounced. (20) Member States should adopt adequate measures to guarantee the proper functioning of the management and control system and the quality of implementation of their national programmes. To this end, it is necessary to establish the general principles and necessary functions which these systems should fulfil. (21) The obligations on the Member States as regards management and control systems and the prevention, detection and correction of irregularities and infringements of Union law should be specified in order to guarantee the efficient and correct implementation of their national programmes. (22) In accordance with the principles of subsidiarity and proportionality, Member States should have the primary responsibility, through their management and control systems, for the implementation and control of national programmes. The support provided under the Specific Regulations should be implemented in close cooperation between the Commission and the Member States in accordance with the principle of subsidiarity. (23) Member States should make full use of the knowledge, expertise and experience gained by public and/or private bodies in implementing earlier funds in the field of home affairs. (24) Only Responsible Authorities designated by the Member States offer reasonable assurance that the necessary controls have been carried out before granting support from the Union budget to beneficiaries. It should therefore be explicitly laid down that only expenditure effected by designated Responsible Authorities can be reimbursed from the Union budget. (25) The powers and responsibilities of the Commission to verify the effective functioning of the management and control systems and to require Member State action should be laid down. (26) Union budget commitments should be effected annually. In order to ensure effective programme management, it is necessary to lay down common rules for the payment of the annual balance and the final balance. (27) The pre-financing payment at the start of programmes ensures that Member States have the means to provide support to beneficiaries in the implementation of the programme once the programme is approved. Therefore, provisions should be made for initial pre-financing amounts. Initial pre-financing should be totally cleared at closure of the programme. The Responsible Authorities should ensure that beneficiaries receive the full amount due promptly. (28) In addition, annual pre-financing should be provided to ensure that Member States have sufficient means to implement their national programmes. Annual pre-financing should be cleared each year with the payment of the annual balance. (29) The triennial revision of Regulation (EU, Euratom) No 966/2012 introduces changes in the shared management method which have to be taken into account. (30) With a view to strengthening accountability for expenditure co-financed by the Union budget in any given year, an appropriate framework should be created for the annual clearance of accounts. Under such framework, the Responsible Authority should submit to the Commission, in respect of a national programme, the documents referred to in the provisions on shared management with Member States of Regulation (EU, Euratom) No 966/2012. (31) To support the assurance underlying the annual clearance of accounts across the Union, common provisions should be laid down on the nature and level of the controls to be carried out by Member States. (32) In order to ensure the sound financial management of Union resources, it may be necessary for the Commission to make financial corrections. To ensure legal certainty for the Member States, it is important to define the circumstances under which breaches of applicable Union or national law can lead to financial corrections by the Commission. In order to ensure that any financial corrections which the Commission may impose on Member States are related to the protection of the Union\u2019s financial interests, they should be confined to cases where the breach of Union or national law directly or indirectly concerns the eligibility, regularity, management or control of actions and the corresponding expenditure. To ensure proportionality, it is important that the Commission considers the nature and the gravity of the breach in deciding the amount of financial correction. In this regard, it is appropriate to set out the criteria for applying financial corrections by the Commission and the procedure that may lead to a decision on the financial correction. (33) In order to establish the financial relationship between the Responsible Authorities and the Union budget, the Commission should clear the accounts of those authorities annually. The decision on the clearance of accounts should cover the completeness, the accuracy and veracity of the accounts but not the conformity of the expenditure with Union law. (34) As the Commission is responsible for the proper application of Union law under Article 17 TEU, it should decide whether the expenditure incurred by the Member States complies with Union law. Member States should be given the right to justify their decisions to make payments. In order to give Member States legal and financial assurances as to expenditure effected in the past, a maximum period should be set for the Commission to decide which financial consequences should follow from non-compliance. (35) It is important to ensure sound financial management and effective implementation, while also ensuring transparency, legal certainty, accessibility of funding and equal treatment of beneficiaries. (36) With a view to simplifying the use of funding and reducing the risk of error, while providing for differentiation where needed to reflect the specificities of policy, it is appropriate to define the forms of support and the harmonised conditions for the eligibility of expenditure grants, including simplified costs options. In accordance with the principle of subsidiarity, Member States should adopt national rules on the eligibility of expenditure. (37) In order to encourage financial discipline, it is appropriate to define the arrangements for decommitment of any part of the budget commitment in a national programme, in particular where an amount may be excluded from the decommitment, notably when delays in the implementation result from legal proceedings or an administrative appeal having suspensive effect or from reasons of force majeure. (38) To ensure the appropriate application of the general rules on decommitment, the rules established should detail how the deadlines for decommitment are established and how the respective amounts are calculated. (39) It is important to bring the achievements of Union funding to the attention of the general public. Citizens have a right to know how the Union\u2019s financial resources are spent. The responsibility to ensure that the appropriate information is communicated to the public should lie with the Commission, the Responsible Authorities and the beneficiaries. To ensure more efficiency in communication to the public at large and stronger synergies between the communication activities undertaken at the initiative of the Commission, the budget allocated to communication actions under this Union funding should also contribute to covering corporate communication of the political priorities of the Union, provided that those are related to the general objectives of Union funding in the field of home affairs. (40) For the purpose of ensuring a wide dissemination of information about Union funding in the field of home affairs, and to inform potential beneficiaries about funding opportunities, detailed rules relating to information and communication measures, as well as certain technical characteristics of such measures, should be defined on the basis of this Regulation and each Member State should, at least, establish a website or website portal with the necessary information. Member States should undertake more direct forms of communication campaigns in order to properly inform the potential beneficiaries by, inter alia, organising regular public events, so-called information days and training sessions. (41) The effectiveness of actions supported also depends on their evaluation and the dissemination of their results. The responsibilities of the Member States and the Commission in this regard and the arrangements to ensure the reliability of evaluation and the quality of the related information should be formalised. (42) In order to amend provisions of this Regulation on the common principles on the eligibility of expenditure, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (43) In the application of this Regulation, including the preparation of delegated acts, the Commission should consult experts from all Member States. (44) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). (45) The examination procedure should be used for implementing acts that lay down common obligations on Member States, in particular on the provision of information to the Commission, and the advisory procedure should be used for the adoption of implementing acts relating to the model forms for the provision of information to the Commission, given their purely technical nature. (46) Since the objective of this Regulation, namely to lay down general provisions for the implementation of the Specific Regulations, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (47) Insofar as this Regulation lays down general rules necessary for enabling the implementation of Specific Regulations which provide for its applicability to these Specific Regulations and which constitute acts building upon the Schengen acquis in relation to countries to which these Specific Regulations are applicable on the basis of relevant Protocols annexed to the TEU and to the TFEU or on the basis of the relevant Agreements, this Regulation should be applied together with these Specific Regulations. To that extent, this implies that this Regulation can establish a link with and can have a direct impact on the provisions of the Specific Regulations developing the Schengen acquis, thus affecting the latter\u2019s legal framework. (48) In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, those Member States have notified their wish to take part in the adoption and application of this Regulation. (49) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (50) It is appropriate to align the period of application of this Regulation with that of Council Regulation (EU, Euratom) No 1311/2013 (7). Therefore, this Regulation should apply as from 1 January 2014, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Purpose and scope This Regulation lays down general rules for the implementation of the Specific Regulations with regard to: (a) the financing of expenditure; (b) partnership, programming, reporting, monitoring and evaluation; (c) the management and control systems to be put in place by the Member States; and (d) the clearance of accounts. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (a) \u2018Specific Regulations\u2019 means \u2014 Regulation (EU) No 516/2014 of the European Parliament and of the Council (8); \u2014 Regulation (EU) No 513/2014 of the European Parliament and of the Council (9); and \u2014 any other regulation which provides for the application of this Regulation; (b) \u2018programming\u2019 means the process of organisation, decision-making and financing in several stages intended to implement, on a multiannual basis, the joint action by the Union and the Member States to achieve the objectives of the Specific Regulations; (c) \u2018action\u2019 means a project or group of projects selected by the Responsible Authority of the national programme concerned, or under its responsibility, contributing to the general and specific objectives pursued by the Specific Regulations; (d) \u2018Union action\u2019 means a transnational action or action of particular interest to the Union as defined in the Specific Regulations; (e) \u2018project\u2019 means the specific practical means deployed to implement all or a part of an action by a beneficiary of a Union contribution; (f) \u2018emergency assistance\u2019 means a project or group of projects addressing an emergency situation as defined in the Specific Regulations; (g) \u2018beneficiary\u2019 means the recipient of a Union contribution under a project, whether a public or private body, international organisation or the International Committee of the Red Cross (\u2018ICRC\u2019), or the International Federation of National Red Cross and Red Crescent Societies. CHAPTER II PRINCIPLES OF ASSISTANCE Article 3 General principles 1. The Specific Regulations shall provide support, through national programmes, Union actions and emergency assistance, which complements national, regional and local intervention, pursuing the objectives of the Union and resulting in added value for the Union. 2. The Commission and the Member States shall ensure that the support provided under the Specific Regulations and by the Member States is consistent with the relevant activities, policies and priorities of the Union and is complementary to other Union instruments, while taking into account the specific context of each Member State. 3. The support provided under the Specific Regulations shall be implemented in close cooperation between the Commission and the Member States. 4. In accordance with their respective responsibilities, the Commission and the Member States, together with the European External Action Service (\u2018EEAS\u2019) as regards actions in and in relation to third countries, shall ensure coordination between this Regulation and the Specific Regulations, and with other relevant Union policies, strategies and instruments, including those in the framework of the Union\u2019s external action. 5. The Commission and the Member States, together with the EEAS where appropriate, shall ensure that actions in and in relation to third countries are carried out in synergy and in coherence with other actions outside the Union supported through Union instruments. They shall, in particular, ensure that those actions: (a) are coherent with the Union\u2019s external policy, respect the principle of policy coherence for development and are consistent with the strategic programming documents for the region or country in question; (b) focus on non-development-oriented measures; (c) serve the interests of the Union\u2019s internal policies and are consistent with activities undertaken inside the Union. 6. The Commission and the Member States shall apply the principle of sound financial management in accordance with Regulation (EU, Euratom) No 966/2012, in particular in accordance with the principles of economy, efficiency and effectiveness as provided for in Article 30 of that Regulation. 7. The Commission and the Member States shall ensure the effectiveness of the support provided under the Specific Regulations, including through monitoring, reporting and evaluation. 8. The Commission and the Member States shall carry out their respective roles in relation to this Regulation and the Specific Regulations with the aim of reducing the administrative burden for beneficiaries, the Member States and the Commission, taking into account the principle of proportionality. Article 4 Compliance with Union and national law Actions financed by the Specific Regulations shall comply with applicable Union and national law. Article 5 Protection of the financial interests of the Union 1. The Commission shall take appropriate measures ensuring that, when actions financed under this Regulation and the Specific Regulations are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks, by the recovery of the amounts wrongly paid if irregularities are detected, and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties. 2. Member States shall prevent, detect and correct irregularities and shall recover amounts unduly paid together with any interest on late payments. They shall notify those to the Commission and shall keep it informed of any significant progress in the related administrative and legal proceedings. 3. When amounts unduly paid to a beneficiary, as a result of fault or negligence on the part of a Member State cannot be recovered, that Member State shall be responsible for reimbursing the relevant amounts to the Union budget. 4. Member States shall offer effective prevention against fraud, especially as regards areas with a higher level of risk. Such prevention shall act as a deterrent, having regard to the benefits as well as the proportionality of the measures. 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 58 concerning the obligations of Member States specified in paragraphs 2 and 3 of this Article. 6. The Commission shall set out, by way of implementing acts, the frequency of the reporting of irregularities and the reporting format to be used. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 59(2). 7. The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds in accordance with this Regulation and the Specific Regulations. 8. OLAF may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (10) and Council Regulation (Euratom, EC) No 2185/96 (11), with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement, grant decision or a contract funded in accordance with this Regulation and the Specific Regulations. 9. Without prejudice to paragraphs 1, 7 and 8, cooperation agreements with third countries and international organisations, contracts, grant agreements and grant decisions resulting from the implementation of this Regulation and the Specific Regulations shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences. CHAPTER III FINANCIAL FRAMEWORK FOR UNION ACTIONS, EMERGENCY AND TECHNICAL ASSISTANCE Article 6 Implementation framework 1. The Commission shall establish the overall amount made available for Union actions, emergency assistance and technical assistance at the initiative of the Commission under the annual appropriations of the Union budget. 2. The Commission shall adopt, by way of implementing acts, the work programme for Union actions and emergency assistance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3). 3. To ensure a timely availability of resources, the Commission may separately adopt a work programme for emergency assistance. 4. Union actions, emergency assistance and technical assistance at the initiative of the Commission may be implemented either directly, by the Commission or through executive agencies, or indirectly, by entities and persons other than Member States in accordance with Article 60 of Regulation (EU, Euratom) No 966/2012. Article 7 Emergency assistance 1. In response to an emergency situation as defined in the Specific Regulations, the Commission may decide to provide emergency assistance. In such cases, it shall inform the European Parliament and the Council in a timely manner. 2. Within the limits of the available resources, the emergency assistance may amount to 100 % of the eligible expenditure. 3. Emergency assistance may consist of assistance in Member States and in third countries in accordance with the objectives and actions defined in the Specific Regulations. 4. Emergency assistance may support expenditure which was incurred prior to the date of submission of the grant application or the request for assistance, but not prior to 1 January 2014, when necessary for the implementation of the action. 5. Emergency assistance may take the form of grants awarded directly to Union agencies. Article 8 Union actions and emergency assistance in or in relation to third countries 1. The Commission may decide to finance Union actions and emergency assistance in or in relation to third countries in accordance with the objectives and actions defined in the Specific Regulations. 2. Where such actions are implemented directly, the following entities shall be allowed to submit grant applications: (a) Member States; (b) third countries, in duly justified cases where a grant is necessary to achieve the objectives of this Regulation and the Specific Regulations; (c) joint bodies set up by third countries and the Union or by Member States; (d) international organisations, including regional organisations, UN bodies, departments and missions, international financial institutions and development banks and institutions of international jurisdiction in so far as they contribute to the objectives of the Specific Regulation(s) concerned; (e) the ICRC and International Federation of National Red Cross and Red Crescent Societies; (f) non-governmental organisations established and registered in the Union and in the countries associated with the implementation, application and development of the Schengen acquis; (g) Union agencies for emergency assistance. Article 9 Technical assistance at the initiative of the Commission 1. At the initiative of or on behalf of the Commission, the Specific Regulations may support the preparatory, monitoring, administrative and technical assistance, evaluation, audit and control measures and activities necessary for the implementation of this Regulation and the Specific Regulations. 2. The measures and activities referred to in paragraph 1 may include: (a) assistance for project preparation and appraisal; (b) support for institutional strengthening and administrative capacity building for the effective management of this Regulation and the Specific Regulations; (c) measures related to the analysis, management, monitoring, information exchange and implementation of this Regulation and the Specific Regulations, as well as measures relating to the implementation of control systems and technical and administrative assistance; (d) evaluations, expert reports, statistics and studies, including those of a general nature concerning the operation of the Specific Regulations; (e) actions to disseminate information, support networking, carry out communication activities, raise awareness and promote cooperation and exchanges of experience, including with third countries. To bring about greater efficiency in communication to the public at large and stronger synergies between the communication activities undertaken at the initiative of the Commission, the resources allocated to communication actions under this Regulation shall also contribute to covering the corporate communication of the political priorities of the Union, provided that those are related to the general objectives of this Regulation and the Specific Regulations; (f) the installation, updating, operation and interconnection of computerised systems for management, monitoring, audit, control and evaluation; (g) the design of a common framework for evaluation and monitoring, as well as a system of indicators, taking into account, where appropriate, national indicators; (h) actions to improve evaluation methods and the exchange of information on evaluation practices; (i) conferences, seminars, workshops and other common information and training measures on the implementation of this Regulation and the Specific Regulations for competent authorities and beneficiaries; (j) actions related to fraud detection and prevention; (k) actions related to audit. 3. The measures and activities referred to in paragraph 1 may also concern the preceding and subsequent financial frameworks. CHAPTER IV NATIONAL PROGRAMMES SECTION 1 Programming and Implementation framework Article 10 Programming The objectives of the Specific Regulations shall be pursued within the framework of the multiannual programming for the period 2014-20, subject to a mid-term review in accordance with Article 15. Article 11 Subsidiary and proportionate intervention 1. Member States and their competent authorities as specified in Article 25 shall be responsible for implementing programmes and carrying out their tasks under this Regulation and the Specific Regulations at the appropriate level, in accordance with the institutional, legal and financial framework of the Member State concerned and subject to compliance with this Regulation and the Specific Regulations. 2. Arrangements for the implementation and use of the support provided under the Specific Regulations, and in particular the financial and administrative resources required in relation to reporting, evaluation, management and control, shall take into account the principle of proportionality having regard to the level of support allocated, thereby reducing the administrative burden and facilitating efficient implementation. Article 12 Partnership 1. Each Member State shall, in accordance with its national rules and practices and subject to any applicable security requirements, organise a partnership with relevant authorities and bodies to perform the role set out in paragraph 3. The partnership shall be drawn from relevant public authorities at national, regional and local level, where applicable. It shall also, where deemed appropriate, include relevant international organisations, non-governmental organisations and social partners. 2. The partnership shall be conducted in full compliance with the respective institutional, legal and financial jurisdiction of each partner category. 3. The Member State shall involve the partnership in the preparation, implementation, monitoring and evaluation of national programmes. The composition of the partnership may vary at different stages of the programme. 4. Each Member State shall set up a monitoring committee to support the implementation of national programmes. 5. The Commission may provide guidance on the monitoring of national programmes and, where necessary and in agreement with the Member State concerned, may participate in the work of the monitoring committee in an advisory capacity. Article 13 Policy dialogue 1. In order to facilitate the preparation of the national programmes, each Member State and the Commission shall hold a dialogue at the level of senior officials, taking into account the relevant indicative timeframes laid down in Article 14. The dialogue shall focus on the overall results to be achieved by means of the national programmes in order to address the needs and priorities of the Member States in the areas of intervention covered by the Specific Regulations, taking account of the baseline situation in the Member State concerned and the objectives of the Specific Regulations. The dialogue shall also serve as an opportunity for an exchange of views on Union actions. The outcome of the dialogue shall serve as a guide for the preparation and approval of the national programmes and shall include an indication of the expected date of submission of the Member State\u2019s national programmes to the Commission, which shall allow the timely adoption of the programme. That outcome shall be recorded in agreed minutes. 2. In the case of actions to be implemented in and in relation to third countries, such actions shall not be directly development-oriented and the policy dialogue shall seek full coherence with the principles and general objectives of the Union\u2019s external action and foreign policy as regards the country or region concerned. 3. After the conclusion of the policy dialogues, the Commission shall inform the European Parliament of the overall outcome. 4. If deemed appropriate by a Member State and by the Commission, the policy dialogue may be repeated after the mid-term review referred to in Article 15, in order to reassess the needs of that Member State and the priorities of the Union. Article 14 Preparation and approval of national programmes 1. Each Member State shall propose, on the basis of the outcome of the policy dialogue referred to in Article 13(1), a multiannual national programme in accordance with the Specific Regulations. 2. Each proposed national programme shall cover the financial years of the period from 1 January 2014 to 31 December 2020, and shall consist of the following elements: (a) a description of the baseline situation in the Member State, completed with the necessary factual information to assess the requirements correctly; (b) an analysis of requirements in the Member State and the national objectives designed to meet those requirements during the period covered by the programme; (c) an appropriate strategy identifying the objectives to be pursued with the support of the Union budget, with targets for their achievement, an indicative time-table and examples of actions envisaged to meet those objectives; (d) a description of how the objectives of the Specific Regulations are covered; (e) the mechanisms that ensure coordination between the instruments established by the Specific Regulations and other Union and national instruments; (f) information on the monitoring and evaluation framework to be put in place and the indicators to be used to measure progress in the implementation of the objectives pursued in relation to the baseline situation in the Member State; (g) implementing provisions for the national programme containing the identification of the competent authorities, and a summary description of the envisaged management and control system; (h) a summary description of the approach chosen for the implementation of the partnership principle laid down in Article 12; (i) a draft financing plan indicatively broken down by each financial year of the period, including an indication of technical assistance expenditure; (j) the mechanisms and methods to be used to publicise the national programme. 3. Member States shall submit the proposed national programmes to the Commission not later than three months after the conclusion of the policy dialogue referred to in Article 13. 4. The Commission shall adopt, by way of implementing acts, the model according to which the national programmes shall be drawn up. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3). 5. Before approving a proposed national programme, the Commission shall examine: (a) its consistency with the objectives of the Specific Regulations and the outcome of the policy dialogue referred to in Article 13(1); (b) the distribution of Union funding between objectives in the light of the requirements of the Specific Regulations and, where relevant, the justification for any deviation from the minimum shares set in the Specific Regulations; (c) the relevance of the objectives, targets, indicators, the time-table and examples of actions envisaged in the proposed national programme in the light of the strategy proposed by Member States; (d) the relevance of the implementing provisions referred to in point (g) of paragraph 2 in the light of the actions envisaged; (e) the compliance of the proposed programme with Union law; (f) the complementarity with support provided by other Union funds, including the European Social Fund; (g) where applicable under a Specific Regulation, for objectives and examples of actions in or in relation to third countries, coherence with the principles and general objectives of the Union\u2019s external action and foreign policy related to the country or region concerned. 6. The Commission shall make observations within three months of the date of submission of the proposed national programme. Where the Commission considers that a proposed national programme is inconsistent with the objectives of the Specific Regulation, in the light of the national strategy, or that the Union funding to be allocated to those objectives is insufficient or that the programme does not comply with Union law, it shall invite the Member State concerned to provide all necessary additional information and, where appropriate, to modify the proposed national programme. 7. The Commission shall approve each national programme not later than six months following the formal submission by the Member State, provided that any observations made by the Commission have been adequately taken into account. 8. Without prejudice to paragraph 7, the Commission shall inform the European Parliament of the overall outcome of the application of paragraphs 5 and 6, including compliance with or derogation from the minimum percentages set per objective in the relevant Specific Regulations. 9. In the light of new or unforeseen circumstances, at the initiative of the Commission or the Member State concerned, an approved national programme may be re-examined and, if necessary, revised for the rest of the programming period. Article 15 Mid-term review 1. In 2018 the Commission and each Member State shall review the situation, in the light of the interim evaluation reports submitted by the Member States in accordance with point (a) of Article 57(1), and in the light of developments in Union policies and in the Member State concerned. 2. Following the review- referred to in paragraph 1, and in the light of its outcome, national programmes may be revised. 3. The rules laid down in Article 14 on the preparation and approval of national programmes shall apply mutatis mutandis to the preparation and approval of the revised national programmes. 4. After the completion of the mid-term review, and as part of the interim evaluation referred to in point (a) of Article 57(2), the Commission shall report on the mid-term review to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 16 Financing structure 1. Financial contributions provided under the national programmes shall take the form of grants. 2. Actions supported under the national programmes shall be co-financed by public or private sources, shall be of a non-profit nature and shall not be subject to funding from other sources covered by the Union budget. 3. The contribution from the Union budget shall not exceed 75 % of the total eligible expenditure of a project. 4. The contribution from the Union budget may be increased to 90 % under specific actions or strategic priorities as defined in the Specific Regulations. 5. The contribution from the Union budget may be increased to 90 % in exceptional duly justified circumstances, for example when, due to economic pressure on the national budget, projects would otherwise not be implemented and the objectives of the national programme would not be achieved. 6. The contribution from the Union budget to the technical assistance at the initiative of Member States may amount to 100 % of the total eligible expenditure. Article 17 General principles of eligibility 1. The eligibility of expenditure shall be determined on the basis of national rules, except where specific rules are laid down in this Regulation or in the Specific Regulations. 2. In accordance with the Specific Regulations, for expenditure to be eligible, it must be: (a) within the scope of the Specific Regulations and their objectives; (b) needed to carry out the activities covered by the project concerned; (c) reasonable and comply with the principles of sound financial management, in particular value for money and cost-effectiveness. 3. Expenditure shall be eligible for support under the Specific Regulations if: (a) it has been incurred by a beneficiary between 1 January 2014 and 31 December 2022; and (b) it has been disbursed by the designated Responsible Authority between 1 January 2014 and 30 June 2023. 4. By way of derogation from paragraph 3, expenditure paid in 2014 shall also be eligible where it has been paid by the Responsible Authority before its formal designation in accordance with Article 26, provided that the management and controls systems applied before the formal designation are essentially the same as the ones in force after the formal designation of the Responsible Authority. 5. Expenditure included in payment requests from the beneficiary to the Responsible Authority shall be supported by invoices or accounting documents of equivalent probative value, except for forms of support under points (b), (c) and (d) of Article 18(1). For such forms of support, by way of derogation from paragraph 3 of this Article, the amounts included in the payment request shall be the cost reimbursed to the beneficiary by the Responsible Authority. 6. Net revenue directly generated by a project during its implementation which has not been taken into account at the time of approval of the project shall be deducted from the eligible expenditure of the project at the latest in the final payment request submitted by the beneficiary. Article 18 Eligible expenditure 1. Eligible expenditure may be reimbursed in the following ways: (a) reimbursement of eligible costs actually incurred and paid, together with, where applicable, depreciation; (b) standard scales of unit costs; (c) lump sums; (d) flat-rate financing determined by the application of a percentage to one or more defined categories of costs. 2. The options referred to in paragraph 1 may be combined where each option covers different categories of costs, or where they are used for different projects forming a part of an action or for successive phases of an action. 3. Where a project is implemented exclusively through the public procurement of works, goods or services, only point (a) of paragraph 1 shall apply. Where the public procurement within a project is limited to certain categories of costs, all the options referred to in paragraph 1 may apply. 4. The amounts referred to in points (b), (c) and (d) of paragraph 1 shall be established in one of the following ways: (a) a fair, equitable and verifiable calculation method based on: (i) statistical data or other objective information; (ii) the verified historical data of individual beneficiaries; or (iii) the application of the usual cost accounting practices of individual beneficiaries; (b) in accordance with the rules for application of corresponding scale of unit costs, lump sums and flat rates applicable in Union policies for a similar type of project and beneficiary; (c) in accordance with the rules for application of corresponding scale of unit costs, lump sums and flat rates applied under schemes for grants funded entirely by the Member State concerned for a similar type of project and beneficiary. 5. The document setting out the conditions for support for each project shall set out the method to be applied for determining the costs of the project and the conditions for the payment of the grant. 6. Where the implementation of a project gives rise to indirect costs, they may be calculated as a flat rate in one of the following ways: (a) a flat rate of up to 25 % of eligible direct costs, provided that the rate is calculated on the basis of a fair, equitable and verifiable calculation method or a method applied under schemes for grants funded entirely by the Member State concerned for a similar type of project and beneficiary; (b) a flat rate of up to 15 % of eligible direct staff costs without there being a requirement for the Member State concerned to perform a calculation to determine the applicable rate; (c) a flat rate applied to eligible direct costs based on existing methods and corresponding rates, applicable in Union policies for a similar type of project and beneficiary. 7. For the purposes of determining staff costs relating to the implementation of a project, the hourly rate applicable may be calculated by dividing the latest documented annual gross employment costs by 1 720 hours. 8. In addition to the methods laid down in paragraph 4, where the contribution from the Union budget does not exceed 100 000 EUR, the amounts referred to in points (b), (c) and (d) of paragraph 1 may be established on a case-by-case basis by reference to a draft budget agreed ex ante by the Responsible Authority. 9. Depreciation costs may be considered as eligible where the following conditions are met: (a) the eligibility rules of the national programme allow for it; (b) the amount of the expenditure is duly justified by supporting documents having equivalent probative value to invoices for eligible costs where reimbursed in the form referred to in point (a) of paragraph 1; (c) the costs relate exclusively to the period of support for the project; (d) support from the Union budget has not contributed towards the acquisition of the depreciated assets. 10. Without prejudice to Article 43, for the purpose of paragraph 8 of this Article the Member States whose currency is not the euro may use the euro conversion rate fixed on the date of project approval or project agreement signature based on the monthly accounting exchange rate published electronically by the Commission. The euro conversion rate shall not be subject to modification in course of the project. Article 19 Ineligible expenditure The following costs shall not be eligible for a contribution from the Union budget under the Specific Regulations: (a) interest on debt; (b) the purchase of land not built upon; (c) the purchase of land built upon, where the land is necessary for the implementation of the project, in an amount exceeding 10 % of the total eligible expenditure for the project concerned; (d) value added tax (VAT), except where it is non-recoverable under national VAT law. Article 20 Technical assistance at the initiative of the Member States 1. At the initiative of a Member State for each national programme, the Specific Regulations may support actions for preparation, management, monitoring, evaluation, information and communication, networking, control and audit, as well as measures for the reinforcement of the administrative capacity for the implementation of this Regulation and the Specific Regulations. 2. The measures referred to in paragraph 1 may include: (a) expenditure relating to the preparation, selection, appraisal, management and monitoring of the programme, actions or projects; (b) expenditure relating to audits and on-the-spot controls of actions or projects; (c) expenditure relating to evaluations of the programme, actions or projects; (d) expenditure relating to information, dissemination and transparency in relation to the programme, actions or projects, including expenditure resulting from the application of Article 53 and expenditure on campaigns to inform and raise awareness about the programme\u2019s purpose, organised, inter alia, at a local level; (e) expenditure on the acquisition, installation and maintenance of computerised systems for the management, monitoring and evaluation of this Regulation and the Specific Regulations; (f) expenditure on meetings of monitoring committees and sub-committees relating to the implementation of actions; including the costs of experts and other participants in those committees and including third-country participants, where their presence is essential to the effective implementation of programmes, actions or projects; (g) expenditure for the reinforcement of the administrative capacity for the implementation of this Regulation and the Specific Regulations. 3. The appropriations may be used by the Member States to support actions for the reduction of administrative burden for the beneficiaries and competent authorities referred to in Article 25, including electronic data exchange systems, and actions to reinforce the capacity of Member State authorities and beneficiaries to administer and to use the support provided for under the Specific Regulations. 4. The actions may also concern the preceding and subsequent financial frameworks. 5. When one or more competent authorities are common to more than one national programme, the appropriations for the technical assistance expenditure on each of the programmes concerned may be merged, either partly or entirely. SECTION 2 Management and Control Article 21 General principles of management and control systems For the implementation of its national programme, each Member State shall set up management and control systems, which shall provide for: (a) a description of the functions of each authority involved in management and control, and the allocation of functions within each authority; (b) compliance with the principle of separation of functions between and within such authorities; (c) procedures for ensuring the correctness and regularity of expenditure declared; (d) computerised systems for accounting, for the storage and transmission of financial data and data on indicators, for monitoring and for reporting; (e) systems for reporting and monitoring where the Responsible Authority entrusts the execution of tasks to another body; (f) arrangements for auditing the functioning of the management and control systems; (g) systems and procedures to ensure an adequate audit trail; (h) the prevention, detection and correction of irregularities, including fraud, and the recovery of amounts unduly paid, together with any interest on late payments. Article 22 Responsibilities under shared management In accordance with the principle of shared management, Member States and the Commission shall be responsible for the management and control of national programmes in accordance with their respective responsibilities laid down in this Regulation and the Specific Regulations. Article 23 Responsibilities of beneficiaries Beneficiaries shall fully cooperate with the Commission and competent authorities when they carry out their functions and tasks in relation to this Regulation and the Specific Regulations. Article 24 Responsibilities of Member States 1. Member States shall fulfil the management, control and audit obligations and assume the resulting responsibilities, which are laid down in the rules on shared management set out in Regulation (EU, Euratom) No 966/2012 and this Regulation. 2. Member States shall ensure that their management and control systems for national programmes are set up in accordance with this Regulation and that those systems function effectively. 3. Member States shall allocate adequate resources for each competent authority to carry out their functions throughout the programming period. 4. Member States shall set up transparent rules and procedures for the selection and implementation of projects in accordance with this Regulation and the Specific Regulations. 5. All official exchanges of information between the Member State and the Commission shall be carried out using an electronic data exchange system. The Commission shall establish, by way of implementing acts, the terms and conditions with which that electronic data exchange system is to comply. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3). Article 25 Competent authorities 1. For the purposes of this Regulation and the Specific Regulations, the competent authorities are: (a) a Responsible Authority: a public sector body of the Member State concerned, which is the designated body within the meaning of Article 59(3) of Regulation (EU, Euratom) No 966/2012 and which shall be solely responsible for the proper management and control of the national programme and shall handle all communication with the Commission; (b) an Audit Authority: a national public authority or body, which is functionally independent of the Responsible Authority and which shall be responsible for issuing annually the opinion referred to in the second subparagraph of Article 59(5) of Regulation (EU, Euratom) No 966/2012; (c) where appropriate, one or more Delegated Authorities: any public or private body which carries out certain tasks of the responsible authority under the responsibility of the Responsible Authority. 2. Each Member State shall lay down rules governing the relations between the authorities referred to in paragraph 1 and their relations with the Commission. Article 26 Designation of Responsible Authorities 1. Member States shall notify the Commission of the formal designation, in accordance with Article 59(3) of Regulation (EU, Euratom) No 966/2012, at ministerial level of the Responsible Authorities in Member States responsible for the management and control of expenditure under this Regulation, as soon as possible after the approval of the national programme. 2. The designation referred to in paragraph 1 shall be made subject to the body complying with the designation criteria on internal environment, control activities, information and communication, and monitoring laid down in or on the basis of this Regulation. 3. The designation of a Responsible Authority shall be based on an opinion of an audit body, which may be the Audit Authority, that assesses the Responsible Authority\u2019s compliance with the designation criteria. That body may be the autonomous public institution responsible for monitoring, evaluating and auditing the administration. The audit body shall function independently of the Responsible Authority and shall carry out its work in accordance with internationally accepted audit standards. In accordance with Article 59(3) of Regulation (EU, Euratom) No 966/2012, Member States may base their decision on designation on whether the management and control systems are essentially the same as those in place for the previous period and whether they have functioned effectively. If the existing audit and control results show that the designated bodies no longer comply with the designation criteria, Member States shall take the necessary measures to ensure that deficiencies in the implementation of the tasks of those bodies are remedied, including by ending the designation. 4. To ensure the sound operation of this system, the Commission shall be empowered to adopt delegated acts in accordance with Article 58 concerning: (a) minimum conditions for the designation of the Responsible Authorities with regard to the internal environment, control activities, information and communication, and monitoring, as well as rules on the procedure for making and ending the designation; (b) rules relating to supervision and the procedure for reviewing the designation of Responsible Authorities; (c) the obligations of the Responsible Authorities as regards public intervention, as well as on the content of their management and control responsibilities. Article 27 General principles on controls by Responsible Authorities 1. Responsible Authorities shall carry out a systematic administrative control and shall supplement such a control by on-the-spot controls, including, where appropriate, unannounced on-the-spot controls of the expenditure related to the final payment requests from the beneficiaries that are declared in the annual accounts with a view to obtaining a sufficient level of assurance. 2. As regards on-the-spot controls, the Responsible Authority shall draw its control sample from the entire population of beneficiaries comprising, where appropriate, a random part and a risk-based part, in order to obtain a representative error rate and a minimum confidence level, while targeting also the highest errors. 3. The Responsible Authority shall draw up a control report on each on-the-spot control. 4. Where problems detected appear to be systemic in nature and may therefore entail a risk to other projects, the Responsible Authority shall ensure that a further examination is carried out, including additional controls where necessary, to establish the scale of such problems and whether the error rate is above the acceptable level. The necessary preventive and corrective measures shall be taken by the Responsible Authority and shall be communicated to the Commission in the summary referred to in point (b) of the first subparagraph of Article 59(5) of Regulation (EU, Euratom) No 966/2012. 5. The Commission shall adopt, by way of implementing acts, the necessary rules aiming at achieving a uniform application of this Article. Those rules may in particular relate to the following: (a) the rules concerning administrative and on-the-spot controls including unannounced on-the-spot controls, to be conducted by the Responsible Authority with regard to compliance with obligations, commitments and eligibility rules resulting from the application of this Regulation and the Specific Regulations, including the rules relating to the period of time for which supporting documents should be kept; (b) the rules on the minimum level of on-the-spot controls necessary for an effective management of the risks, as well as the conditions under which Member States have to increase such controls, or may reduce them where the management and control systems function properly and the error rates are at an acceptable level; (c) the rules and methods on the reporting of the controls and verification carried out and their results. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3). Article 28 Payment to beneficiaries Responsible Authorities shall ensure that the beneficiaries receive the total amount of the public support as quickly as possible and in full. No amount shall be deducted or withheld and no specific charge or other charge with equivalent effect shall be levied that would reduce those amounts for the beneficiaries. Article 29 Functions of the audit authority 1. To support the opinion given in accordance with Article 59 of Regulation (EU, Euratom) No 966/2012, the audit authority shall ensure that audits are carried out on the management and control systems, and on an appropriate sample of the expenditure included in the annual accounts. The Commission shall be empowered to adopt delegated acts in accordance with Article 58 of this Regulation on the status of the Audit Authorities and the conditions which their audits shall fulfil. 2. Where audits are carried out by a body other than the Audit Authority, the Audit Authority shall ensure that any such body has the necessary specialist expertise and functional independence. 3. The Audit Authority shall ensure that audit work meets internationally accepted auditing standards. Article 30 Cooperation with audit authorities 1. The Commission shall cooperate with audit authorities to coordinate their respective audit plans and methods and shall as soon as possible exchange the results of audits carried out on management and control systems in order to make the best possible and proportionate use of control resources, and to avoid unjustified duplication of work. 2. The Commission and the audit authorities shall meet on a regular basis to exchange views on issues relating to the improvement of the management and control systems. Article 31 Controls and audits by the Commission 1. The Commission shall rely on available information, including the designation procedure, the request for payment of the annual balance as referred to in Article 44, annual implementation reports and audits carried out by national and Union bodies, to assess whether the Member States have set up management and control systems that comply with this Regulation, and whether those systems function effectively during the implementation of national programmes. 2. Without prejudice to audits carried out by Member States, Commission officials or authorised Commission representatives may carry out on-the-spot audits or controls subject to giving at least 12 working days notice to the competent national authority, except in urgent cases. The Commission shall respect the principle of proportionality by taking into account the need to avoid unjustified duplication of audits or controls carried out by Member States, the level of risk to the Union budget and the need to minimise the administrative burden on beneficiaries. Officials or authorised representatives of the Member State may take part in such audits or controls. 3. The scope of the audits or controls may include, in particular: (a) the verification of the effective functioning of management and control systems in a national programme or a part thereof; (b) the compliance of administrative practices with Union rules; (c) the existence of the required supporting documents and their correlation with the actions supported under the national programmes; (d) the terms on which the actions have been undertaken and controlled; (e) an assessment of the sound financial management of actions and/or the national programme. 4. Commission officials or authorised Commission representatives, duly empowered to carry out on-the-spot audits or controls, shall have access to all necessary records, documents and metadata, irrespective of the medium in which they are stored, relating to projects and technical assistance or to management and control systems. Member States shall provide copies of such records, documents and metadata to the Commission upon request. The powers set out in this paragraph shall not affect the application of national provisions which reserve certain acts for agents specifically designated by national legislation. Commission officials and authorised representatives shall not take part, inter alia, in home visits or the formal questioning of persons within the framework of national legislation. However, they shall have access to the information thus obtained without prejudice to the competences of national courts and in full respect for the fundamental rights of the legal subjects concerned. 5. At the request of the Commission and with the agreement of the Member State concerned, additional controls or inquiries into the actions covered by this Regulation shall be undertaken by the competent bodies of that Member State. Commission agents or persons delegated by the Commission may take part in such controls. In order to improve controls, the Commission may, with the agreement of the Member States concerned, request the assistance of the authorities of those Member States for certain controls or inquiries. 6. The Commission may require a Member State to take the actions necessary to ensure the effective functioning of its management and control systems or the correctness of expenditure in accordance with the applicable rules. SECTION 3 Financial Management Article 32 Budget commitments 1. The budget commitments of the Union in respect of each national programme shall be made in annual instalments during the period from 1 January 2014 to 31 December 2020. 2. The decision of the Commission approving a national programme shall constitute a financing decision within the meaning of Article 84 of Regulation (EU, Euratom) No 966/2012 and, once notified to the Member State concerned, a legal commitment within the meaning of that Regulation. 3. For each national programme, the budget commitment for the first instalment shall follow the approval of the national programme by the Commission. 4. The budget commitments for subsequent instalments shall be made by the Commission before 1 May of each year, on the basis of the decision referred to in paragraph 2 of this Article, except where Article 16 of Regulation (EU, Euratom) No 966/2012 applies. Article 33 Common rules for payments 1. Payments by the Commission of the contribution from the Union budget to the national programme shall be made in accordance with budget appropriations and shall be subject to available funding. Each payment shall be posted to the earliest open budget commitment concerned. 2. Payments shall take the form of initial pre-financing, annual pre-financing, payments of the annual balance and the payment of the final balance. 3. Article 90 of Regulation (EU, Euratom) No 966/2012 shall apply. Article 34 Accumulation of initial pre-financing and annual balances 1. The total of the initial pre-financing payment and the payments of the annual balance shall not exceed 95 % of the contribution from the Union budget to the national programme concerned. 2. When the ceiling of 95 % is reached, the Member States may continue transmitting requests for payment to the Commission. Article 35 Pre-financing arrangements 1. Following the Commission decision approving the national programme, an initial pre-financing amount for the whole programming period shall be paid within four months by the Commission to the designated Responsible Authority. That initial pre-financing amount shall represent 4 % of the total contribution from the Union budget to the national programme concerned. It may be split into two instalments, depending on budget availability. 2. An annual pre-financing amount of 3 % of the total contribution from the Union budget to the national programme concerned shall be paid before 1 February 2015. For the years in the period 2016-22, it shall be 5 % of the total contribution from the Union budget to the national programme concerned. 3. If a national programme is approved in 2015 or later, the initial pre-financing and annual pre-financing shall be paid not later than 60 days after the approval of the national programme, depending on budget availability. 4. In the case of amendments to the total contribution from the Union budget to a national programme, the initial as well as the annual pre-financing amounts shall be revised accordingly and reflected in the financing decision. 5. Pre-financing shall be used for making payments to beneficiaries implementing the national programme as well as for competent authorities for expenditure relating to technical assistance. It shall be made available without delay to the Responsible Authority for those purposes. Article 36 Clearance of pre-financing 1. The amount paid as initial pre-financing shall be totally cleared from the Commission accounts in accordance with Article 40, at the latest when the national programme is closed. 2. The amount paid as annual pre-financing shall be cleared from the Commission accounts in accordance with Article 39. 3. The total amount paid as pre-financing shall be reimbursed to the Commission if no payment request in accordance with Article 44 is sent within 36 months of the date on which the Commission pays the first instalment of the initial pre-financing amount. 4. Interest generated on the initial pre-financing shall be posted to the national programme concerned and shall be deducted from the amount of public expenditure indicated on the final payment request. Article 37 Internal assignment of revenue 1. The following shall be regarded as internal assigned revenue within the meaning of Article 21 of Regulation (EU, Euratom) No 966/2012: (i) sums which, under Articles 45 and 47 of this Regulation, are paid to the Union budget, including interest; (ii) sums which, following the closure of programmes under the preceding multiannual financial framework, are paid to the Union budget, including interest. 2. The sums referred to in paragraph 1 shall be paid to the Union budget and, in the event of reuse, shall be used in the first instance to finance expenditure under the Specific Regulations. Article 38 Definition of the financial year For the purpose of this Regulation, the financial year, as referred to in Article 59 of Regulation (EU, Euratom) No 966/2012, shall cover expenditure paid and revenue received and entered into the accounts of the Responsible Authority in the period commencing on 16 October of year \u2018N-1\u2019 and ending on 15 October of year \u2018N\u2019. Article 39 Payment of the annual balance 1. The Commission shall pay the annual balance, on the basis of the financial plan in force, the annual accounts for the corresponding financial year of the national programme and the corresponding clearance decision. 2. The annual accounts shall cover the payments made by the Responsible Authority, including the payments relating to technical assistance, during the financial year for which the control requirements referred to in Article 27 have been met. 3. Depending on budget availability, the annual balance shall be paid not later than six months after the information and documents referred to in Article 44(1) and Article 54 are considered admissible by the Commission and the latest annual accounts have been cleared. Article 40 Closure of the programme 1. Member States shall submit the following documents by 31 December 2023: (a) the information required for the last annual accounts, in accordance with Article 44(1); (b) a request for payment of the final balance; and (c) the final implementation report for the national programme as referred to in Article 54(1). 2. The payments made by the Responsible Authority from 16 October 2022 to 30 June 2023 shall be included in the last annual accounts. 3. After receiving the documents listed in paragraph 1, the Commission shall pay the final balance, on the basis of the financial plan in force, the last annual accounts and the corresponding clearance decision. 4. Depending on budget availability, the final balance shall be paid not later than three months after the date of clearance of accounts of the final financial year, or one month after the date of acceptance of the final implementation report, whichever date is later. The amounts still committed after the balance is paid shall, without prejudice to Article 52, be decommitted by the Commission within a period of six months. Article 41 Interruption of the payment deadline 1. The payment deadline following a request for payment may be interrupted by the authorising officer by delegation within the meaning of Regulation (EU, Euratom) No 966/2012 for a maximum period of six months, when at least one of the following conditions is met: (a) further to information provided by a national or Union audit body, there is clear evidence to suggest a significant deficiency in the functioning of the management and control system; (b) the authorising officer by delegation has to carry out additional verifications following information brought to his attention alerting him that expenditure in a payment request is linked to an irregularity having serious financial consequences; (c) one or more documents required under Article 44(1) were not submitted. The Member State concerned may agree to an extension of the interruption period for an additional three months. 2. The authorising officer by delegation shall limit the interruption to the part of the expenditure covered by the payment request affected by the elements referred to in the first subparagraph of paragraph 1, unless it is not possible to identify the part of expenditure affected. The authorising officer by delegation shall inform the Member State and the Responsible Authority immediately in writing of the reason for the interruption and shall ask them to remedy the situation. The interruption shall be ended by the authorising officer by delegation as soon as the necessary measures have been taken. Article 42 Suspension of payments 1. All or part of the annual balance may be suspended by the Commission where: (a) there is a serious deficiency in the effective functioning of the management and control system of the national programme which has put at risk the Union contribution to the national programme, and for which corrective measures have not been taken; (b) expenditure in the annual accounts is linked to an irregularity having serious financial consequences which has not been corrected; or (c) the Member State has failed to take the necessary action to remedy the situation giving rise to an interruption under Article 41. 2. The Commission may decide to suspend all or part of an annual balance after having given the Member State concerned the opportunity to present its observations. 3. The Commission shall end the suspension of all or part of an annual balance where the Member State concerned has taken the necessary measures to enable the suspension to be lifted. Article 43 Use of the euro 1. Amounts set out in national programmes submitted by Member States, forecasts of expenditure, statements of expenditure, requests for payments, annual accounts and expenditure mentioned in the annual and final implementation reports shall be denominated in euro. 2. Member States whose currency is not the euro on the date of a payment request shall convert the amounts of expenditure incurred in national currency into euro. Those amounts shall be converted into euro using the monthly accounting exchange rate of the Commission in the month during which the expenditure was registered in the accounts of the Responsible Authority of the national programme concerned. The exchange rate shall be published electronically by the Commission each month. 3. In cases where the euro becomes the currency of a Member State, the conversion procedure set out in paragraph 2 shall continue to apply to all expenditure recorded in the accounts by the Responsible Authority before the date of entry into force of the fixed conversion rate between the national currency and the euro. SECTION 4 Clearance of accounts and financial corrections Article 44 Request for payment of the annual balance 1. By 15 February of the year following the financial year, each Member State shall submit to the Commission the documents and information required under Article 59(5) of Regulation (EU, Euratom) No 966/2012. The documents submitted shall serve as the request for payment of the annual balance. The deadline of 15 February may be exceptionally extended by the Commission to 1 March at the latest upon communication from the Member State concerned. Member States may, at the appropriate level, publish that information. 2. The Commission may ask a Member State to provide further information for the purpose of the annual clearance of the accounts. If a Member State does not provide the requested information by the deadline for its submission set by the Commission, the Commission may take its decision on the clearance of the accounts on the basis of the information in its possession. 3. The Commission shall adopt, by way of implementing acts, the models according to which the documents referred to in paragraph 1 shall be drawn up. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 59(2). Article 45 Annual clearance of accounts 1. By 31 May of the year following the financial year, the Commission shall decide on the clearance of the annual accounts for each national programme. The clearance decision shall cover the completeness, accuracy and veracity of the annual accounts submitted and shall be without prejudice to any subsequent financial corrections. 2. The Commission shall, by way of implementing acts, lay down the arrangements for the implementation of the annual clearance of accounts procedure, as regards the measures to be taken in connection with the adoption of the decision and its implementation, including on the exchange of information between the Commission and the Member States and the deadlines to be respected. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3). Article 46 Financial corrections by Member States Member States shall make the financial corrections required in connection with individual or systemic irregularities detected under the national programmes. Financial corrections shall consist of cancelling all or part of the contribution from the Union budget concerned. The Member States shall take into account the nature and gravity of the irregularities and the financial loss to the Union budget and shall apply a proportionate correction. Amounts cancelled and amounts recovered, as well as the interest thereon, shall be reallocated to the national programme concerned, excluding the amounts resulting from irregularities identified by the Court of Auditors and the Commission services, including OLAF. After the closure of the national programme, the Member State concerned shall refund the sums recovered to the Union budget. Article 47 Conformity clearance and financial corrections by the Commission 1. The Commission shall make financial corrections by cancelling all or part of the Union contribution to a national programme and effecting recovery from the Member State concerned in order to exclude from Union financing any expenditure which is in breach of applicable law, including in relation to deficiencies in the management and control systems of Member States which have been detected by the Commission or the Court of Auditors. 2. A breach of applicable law shall lead to a financial correction only in relation to expenditure which has been declared to the Commission and where one of the following conditions is met: (a) the breach has affected the selection of a project under the national programme, or, in cases where, due to the nature of the breach, it is not possible to establish that impact, there is a substantiated risk that the breach has had such an effect; (b) the breach has affected the amount of expenditure declared for reimbursement by the Union budget, or in cases where, due to the nature of the breach, it is not possible to quantify its financial impact, but there is a substantiated risk that the breach has had such an effect. 3. When deciding on a financial correction under paragraph 1, the Commission shall respect the principle of proportionality by taking account of the nature and gravity of the breach of applicable law and its financial implications for the Union budget. 4. Before the adoption of any decision to refuse financing, the findings from the Commission and the Member State\u2019s replies shall be notified in writing, following which the two parties shall attempt to reach agreement on the action to be taken. 5. Financing may not be refused for: (a) expenditure which is incurred by the Responsible Authority more than 36 months before the Commission notifies the Member State in writing of its findings; (b) expenditure on multiannual actions within the scope of the national programmes, where the final obligation on the beneficiary occurs more than 36 months before the Commission notifies the Member State in writing of its findings; (c) expenditure on actions in national programmes, other than those referred to in point (b), for which the payment or, as the case may be, the final payment, by the Responsible Authority, is made more than 36 months before the Commission notifies the Member State in writing of its findings. 6. The Commission shall, by way of implementing acts, lay down the arrangements for the implementation of the conformity clearance as regards the measures to be taken in connection with the adoption of the decision and its implementation, including the information exchange between the Commission and the Member States and the deadlines to be respected. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3). Article 48 Obligations of Member States A financial correction by the Commission shall not prejudice the Member State\u2019s obligation to pursue recoveries under point (h) of Article 21 of this Regulation and to recover State aid within the meaning of Article 107(1) TFEU and under Article 14 of Council Regulation (EC) No 659/1999 (12). Article 49 Repayment 1. Any repayment due to be made to the Union budget shall be made before the due date indicated in the order for recovery drawn up in accordance with Article 80 of Regulation (EU, Euratom) No 966/2012. That due date shall be the last day of the second month following the issuing of the order. 2. Any delay in making repayment shall give rise to interest on account of late payment, starting on the due date and ending on the date of actual payment. The rate of such interest shall be one-and-a-half percentage points above the rate applied by the European Central Bank in its main refinancing operations on the first working day of the month in which the due date falls. SECTION 5 Decommitment Article 50 Principles 1. National programmes shall be submitted to a decommitment procedure established on the basis that amounts linked to a commitment which are not covered by the initial and annual pre-financing referred to in Article 35 and a request for payment in accordance with Article 44 by 31 December of the second year following that of the budget commitment shall be decommitted. For the purpose of the decommitment, the Commission shall calculate the amount by adding one sixth of the annual budget commitment related to the 2014 total amount contribution to each of the 2015-20 budget commitments. 2. By way of derogation from paragraph 1, the deadlines for decommitment shall not apply to the annual budget commitment related to the 2014 total annual contribution. 3. If the first annual budget commitment is related to the 2015 total annual contribution, by way of derogation from paragraph 1 the deadlines for decommitment shall not apply to the annual budget commitment related to the total annual contribution of 2015. In such cases, the Commission shall calculate the amount under paragraph 1 by adding one fifth of the annual budget commitment related to the 2015 total amount contribution to each of the 2016-20 budget commitments. 4. The commitment related to the last year of the period shall be decommitted in accordance with the rules followed for the closure of the programmes. 5. Any commitment still open on the latest date for expenditure to be eligible, as referred to in Article 17(3), and for which a payment request has not been made by the Responsible Authority within six months after that date shall be automatically decommitted. Article 51 Exceptions to decommitment 1. The amount concerned by decommitment shall be reduced by the amounts that the Responsible Authority has not been able to declare to the Commission because of: (a) actions suspended by legal proceedings or by an administrative appeal having suspensive effect; or (b) reasons of force majeure seriously affecting the implementation of all or part of the national programme. Responsible Authorities claiming force majeure shall demonstrate the direct consequences of the force majeure on the implementation of all or part of the national programme. The reduction may be requested once if the suspension or force majeure lasted up to one year. If the suspension or force majeure lasted more than one year, the reduction may be requested several times, corresponding to the duration of the force majeure or the number of years between the date of the legal or administrative decision suspending the implementation of the action and the date of the final legal or administrative decision. 2. The Member State shall send to the Commission information on the exceptions referred to in paragraph 1 by 31 January, in order for the amount to be declared by the end of the preceding year. 3. The part of the budget commitments for which a payment request has been made, but payment of which has been reduced or suspended by the Commission on 31 December of year N + 2, shall be disregarded in calculating the automatic decommitment. Article 52 Procedure 1. Whenever there is a risk of application of decommitment under Article 50, the Commission shall inform the Member States as soon as possible. 2. On the basis of the information in its possession on 31 January, the Commission shall inform the Responsible Authority of the amount of the decommitment resulting from the information in its possession. 3. The Member State concerned shall have two months to agree to the amount to be decommitted or to submit its observations. 4. The Commission shall carry out the automatic decommitment no later than nine months after the last time-limit resulting from the application of paragraphs 1 to 3. 5. In the event of automatic decommitment, the contribution from the Union budget to the national programme concerned shall be reduced, for the year in question, by the amount automatically decommitted. The Union contribution in the financing plan will be reduced pro rata, unless the Member State produces a revised financing plan. CHAPTER V INFORMATION, COMMUNICATION, MONITORING, EVALUATION AND REPORTING Article 53 Information and publicity 1. Member States and Responsible Authorities shall be responsible for: (a) a website or a website portal providing information on and access to the national programmes in that Member State; (b) informing potential beneficiaries about funding opportunities under the national programmes; (c) publicising to Union citizens the role and achievements of the Specific Regulations, through information and communication actions on the results and impact of the national programmes. 2. Member States shall ensure transparency of the implementation of the national programmes and shall maintain a list of actions supported by each national programme which shall be accessible through the website or the website portal. The list of actions shall include updated information on the final beneficiaries, the names of the projects and the amount of Union funding allocated to them. 3. As a rule, information shall be made public, except where it is restricted due to its confidential nature, particularly concerning security, public order, criminal investigations and the protection of personal data. 4. The Commission shall be empowered to adopt by delegated acts in accordance with Article 58 to lay down rules concerning the information and publicity measures for the public and information measures for beneficiaries. 5. The Commission shall, by way of implementing acts, define the technical characteristics of information and publicity measures. Those implementing acts shall be adopted by the Commission in accordance with the examination procedure referred to in Article 59(3). Article 54 Implementation reports 1. By 31 March 2016 and by 31 March of each subsequent year until and including 2022, the Responsible Authority shall submit to the Commission an annual report on the implementation of each national programme in the previous financial year and may, at the appropriate level, publish that information. The report submitted in 2016 shall cover the financial years 2014 and 2015. The Member State shall submit a final report on the implementation of the national programmes by 31 December 2023. 2. Annual implementation reports shall set out information on: (a) the implementation of the national programme by reference to the financial data and the indicators; (b) any significant issues which affect the performance of the national programme. 3. In the light of the mid-term review as referred to in Article 15, the annual implementation report submitted in 2017 shall set out and assess: (a) the information referred to in paragraph 2; (b) the progress towards achieving the objectives in the national programmes pursued with the contribution from the Union budget; (c) the involvement of relevant partners as referred to in Article 12. 4. The annual implementation report submitted in 2020 and the final implementation report shall, in addition to the information and assessment set out in paragraph 2, include information on and assess the progress towards achieving the objectives of the national programme, bearing in mind the outcome of the policy dialogue referred to in Article 13(1). 5. The annual implementation reports referred to in paragraphs 1 to 4 shall be admissible if they contain all the information required by those paragraphs. The Commission shall inform the Member State concerned within 15 working days from the date of receipt of the annual implementation report if it is not admissible, failing which it shall be deemed admissible. 6. The Commission shall inform the Member State concerned of its observations on the annual implementation report within two months from the date of receipt of the annual implementation report. If the Commission does not provide observations within this deadline, the reports shall be deemed to be accepted. 7. The Commission may make observations on issues in the Responsible Authority\u2019s annual implementation report which affect the implementation of the national programme. Where such observations are made, the Responsible Authority shall provide necessary information with regard to those observations and, where appropriate, inform the Commission of the measures taken. The Commission shall be informed not later than three months after it has made such observations. 8. The Commission shall adopt, by way of implementing acts, the models according to which the annual and final implementation reports shall be drawn up. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 59(2). Article 55 The common monitoring and evaluation framework 1. The Commission shall carry out regular monitoring of this Regulation and the Specific Regulations, where appropriate, in cooperation with the Member States. 2. The implementation of the Specific Regulations shall be evaluated by the Commission in partnership with the Member States in accordance with Article 57. 3. A common monitoring and evaluation framework shall be established with a view to measuring the relevance, effectiveness, efficiency, added value and sustainability of the actions and the simplification and the reduction of administrative burden, in the light of the objectives of this Regulation and the Specific Regulations and the performance of this Regulation and the Specific Regulations as instruments contributing to the development of the area of freedom, security and justice. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 58 to develop further the common monitoring and evaluation framework. 5. Member States shall provide the Commission with the necessary information to permit the monitoring and evaluation of this Regulation and the Specific Regulations. 6. The Commission shall also consider the complementarity between the actions implemented under the Specific Regulations and those pursued under other relevant Union policies, instruments and initiatives. 7. The Commission shall pay particular attention to the monitoring and evaluation of actions and programmes related to third countries, in accordance with Article 8. Article 56 Evaluation of national programmes by Member States 1. Member States shall carry out the evaluations referred to in Article 57(1). The evaluation to be carried out in 2017 shall contribute to improving the quality of the design and the implementation of national programmes, in accordance with the common monitoring and evaluation framework. 2. Member States shall ensure that procedures are in place to produce and collect the data necessary for the evaluations referred to in paragraph 1, including data related to indicators in the common monitoring and evaluation framework. 3. The evaluations referred to in Article 57(1) shall be carried out by experts who are functionally independent of the Responsible Authorities, the Audit Authorities and the Delegated Authorities. Those experts may be affiliated to an autonomous public institution responsible for the monitoring, evaluation and audit of the administration. The Commission shall provide guidance on how to carry out evaluations. 4. The evaluations referred to in Article 57(1) shall be made public in their entirety, except where information is restricted due to its confidential nature, particularly concerning security, public order, criminal investigations and the protection of personal data. Article 57 Evaluation reports by the Member States and the Commission 1. In accordance with the common monitoring and evaluation framework, the Member States shall submit to the Commission: (a) an interim evaluation report on the implementation of actions and progress towards achieving the objectives of their national programmes by 31 December 2017; (b) an ex-post evaluation report on the effects of actions under their national programmes by 31 December 2023. 2. On the basis of the reports referred to in paragraph 1, the Commission shall submit to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions: (a) an interim evaluation report on the implementation of this Regulation and the Specific Regulations at the level of the Union by 30 June 2018. That interim evaluation report shall include an assessment of the mid-term review carried out in accordance with this Regulation and the Specific Regulations; (b) an ex-post evaluation report on the effects of this Regulation and the Specific Regulations, following the closure of the national programmes, by 30 June 2024. 3. The ex-post evaluation of the Commission shall also examine the impact of the Specific Regulations on the development of the area of freedom, security and justice in terms of their contribution to the following objectives: (a) the development of a common culture of border security, law enforcement cooperation and crisis management; (b) the effective management of migration flows into the Union; (c) the development of the Common European Asylum System; (d) the fair and equal treatment of third-country nationals; (e) solidarity and cooperation between Member States in addressing migration and internal security issues; (f) a common approach by the Union on migration and security towards third countries. 4. All evaluation reports pursuant to this Article shall be published in their entirety, except where information is restricted due to its confidential nature, particularly concerning security, public order, criminal investigations and protection of personal data. CHAPTER VI FINAL PROVISIONS Article 58 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 5(5), 26(4), 29(1), 53(4) and 55(4) shall be conferred on the Commission for a period of seven years from 21 May 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of powers shall be tacitly extended for a period of three years, unless the European Parliament or the Council opposes such extension not later than three months before the end of the seven-year period. 3. The delegation of powers referred to in Articles 5(5), 26(4), 29(1), 53(4) and 55(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 5(5), 26(4), 29(1), 53(4) and 55(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. Article 59 Committee Procedure 1. The Commission shall be assisted by the Asylum, Migration and Integration and Internal Security Funds Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act, except for Articles 14(4), 24(5), 45(2), 47(6) and 53(5) of this Regulation. Article 60 Review The European Parliament and the Council shall, on the basis of a proposal from the Commission, review this Regulation by 30 June 2020. Article 61 Entry into force and application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 16 April 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 299, 4.10.2012, p. 108. (2) OJ C 277, 13.9.2012, p. 23. (3) Position of the European Parliament of 13 March 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014. (4) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (5) Commission Decision 1999/352/EC, ECSC, Euratom of 28 April 1999 establishing the European Anti-fraud Office (OLAF) (OJ L 136, 31.5.1999, p. 20). (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, p. 884). (8) Regulation (EU) No 516/2014 of the European Parliament and of the Council of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC (see page 168 of this Official Journal). (9) Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA (see page 93 of this Official Journal). (10) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (11) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (12) Council Regulation (EC) No 659/1999 of 22 March 1999 laying down detailed rules for the application of Article 108 of the Treaty on the Functioning of the European Union (OJ L 83, 27.3.1999, p. 1).", "summary": "Police cooperation, migration, asylum and combating crime: financial instruments Police cooperation, migration, asylum and combating crime: financial instruments SUMMARY OF: Regulation (EU) No 514/2014 on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management WHAT IS THE AIM OF THIS REGULATION? This regulation lays down common rules for the implementation over the 2014-2020 period of the 3 European Union (EU) specific regulations establishing 2 home affairs funding instruments: the Asylum, Migration and Integration Fund; and the Internal Security Fund (which in turn comprises two funding instruments \u2014 ISF-Borders and ISF-Police). KEY POINTS 1. Principles of assistance The regulation lays down the rules for the implementation of the 2 home affairs funds, including the guiding principles, such as compliance with EU and national law, and the protection of the EU\u2019s financial interests. 2. EU (Union) actions, emergency and technical assistance Rules are laid down for actions financed by the home affairs funds and implemented directly by the European Commission or indirectly (Union actions \u2014 actions of benefit to the EU as a whole \u2014 and emergency and technical assistance). 3. National programmes The rules for the preparation and implementation of national programmes are outlined, as well as eligibility rules for these programmes which are implemented by the EU countries. Also, rules on the way the funds should be managed and controlled are set out. To ensure the careful management of EU funding, rules are laid down on aspects such as: how EU countries appoint the bodies responsible for managing programmes and controlling spending; auditing of programmes; suspension of payments. 4. Information and communication, monitoring and evaluation The regulation outlines also the rules to be followed regarding information and publicity, for example that outputs of the projects funded with the home affairs funds should be communicated to the public in a transparent way. Furthermore, the regulation defines the monitoring and evaluation modalities, establishing also the dates when the Commission should present the results of the funds to the European Parliament. 5. Implementing regulations Such rules and principles are further detailed in implementing regulations have been adopted by the Commission specifically dealing with technical aspects such as: information and publicity measures for the public and information measures for beneficiaries to increase awareness of the EU\u2019s role in funding programmes; technical characteristics of information and publicity measures (for example, the format of the EU\u2019s emblem that should appear on publicity material of projects that have received funding); establishing the models for the documents required for the payment of the annual balance (to avoid delays in preparing requests for payments); rules on the implementation of the procedure for annual clearance of accounts and for conformity clearance (i.e. detailed arrangements for these tasks including on the exchanges of information between the Commission and EU countries and deadlines); controls carried out by responsible authorities (to ensure efficient administrative controls of expenditure, including on-the-spot controls of projects). FROM WHEN DOES THIS REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND EU home affairs policies have been steadily growing in importance in recent years. Their aim is to help create a more open and secure Europe. They seek to achieve this by efficiently managing migration flows and preventing crime while enabling legitimate travel and ensuring the management of the EU\u2019s external borders. In late 2013, the EU agreed on a multiannual financial framework (the EU\u2019s long-term budget) for the period from 2014 to 2020. In parallel, the structure of the EU\u2019s spending instruments has been rationalised, resulting in two home affairs funds: an Asylum, Migration and Integration Fund and an Internal Security Fund (which in turn comprises two funding instruments \u2014 ISF-Borders and ISF-Police). MAIN DOCUMENT Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 150, 20.5.2014, pp. 112\u2013142) RELATED DOCUMENTS Regulation (EU) No 516/2014 of the European Parliament and of the Council of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC (OJ L 150, 20.5.2014, pp. 168-194) Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (OJ L 150 of 20.5.2014, pp. 143-167) Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA (OJ L 150, 20.5.2014, pp. 93-111) Commission Delegated Regulation (EU) No 1048/2014 of 30 July 2014 laying down information and publicity measures for the public and information measures for beneficiaries pursuant to Regulation (EU) No 514/2014 of the European Parliament and of the Council laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 291, 7.10.2014, pp. 6\u20138) Commission Implementing Regulation (EU) No 1049/2014 of 30 July 2014 on technical characteristics of information and publicity measures pursuant to Regulation (EU) No 514/2014 of the European Parliament and of the Council laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, prevention and combating crime and crisis management (OJ L 291, 7.10.2014, pp. 9\u201313) Commission Implementing Regulation (EU) 2015/377 of 2 March 2015 establishing the models for the documents required for the payment of the annual balance pursuant to Regulation (EU) No 514/2014 of the European Parliament and of the Council laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 64, 7.3.2015, pp. 17\u201329) Commission Implementing Regulation (EU) 2015/378 of 2 March 2015 laying down rules for the application of Regulation (EU) No 514/2014 of the European Parliament and of the Council with regard to the implementation of the annual clearance of accounts procedure and the implementation of the conformity clearance (OJ L 64, 7.3.2015, pp. 30\u201332) Commission Implementing Regulation (EU) 2015/840 of 29 May 2015 on controls carried out by Responsible Authorities pursuant to Regulation (EU) No 514/2014 of the European Parliament and of the Council laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 134, 30.5.2015, pp. 1\u20135) last update 14.11.2016"}
{"article": "20.5.2014 EN Official Journal of the European Union L 150/168 REGULATION (EU) No 516/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION Having regard to the Treaty on the Functioning of the European Union, and in particular Article 78(2) and Article 79(2) and (4) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Union\u2019s objective to constitute an area of freedom, security and justice should be achieved, inter alia, through common measures framing a policy on asylum and immigration, based on solidarity between Member States, which is fair towards third countries and their nationals. The European Council of 2 December 2009 recognised that financial resources within the Union should be made increasingly flexible and coherent, in terms of both scope and applicability, to support policy developments in the field of asylum and migration. (2) In order to contribute to the development of the common Union policy on asylum and immigration and to the strengthening of the area of freedom, security and justice in the light of the application of the principles of solidarity and responsibility-sharing between the Member States and cooperation with third countries, this Regulation should establish the Asylum, Migration and Integration Fund (\u2018the Fund\u2019). (3) The Fund should reflect the need for increased flexibility and simplification, while respecting requirements in terms of predictability, and ensuring a fair and transparent distribution of resources to meet the general and specific objectives laid down in this Regulation. (4) Efficiency of measures and quality of spending constitute guiding principles in the implementation of the Fund. Furthermore, the Fund should also be implemented in the most effective and user-friendly manner possible. (5) The new two-pillar structure of funding in the field of home affairs should contribute to the simplification, rationalisation, consolidation and transparency of funding in that field. Synergies, consistency and complementarity should be sought between different funds and programmes, including with a view to allocating funding to common objectives. However, any overlap between the different funding instruments should be avoided. (6) The Fund should create a flexible framework allowing Member States to receive financial resources under their national programmes to support the policy areas under the Fund according to their specific situation and needs, and in the light of the general and specific objectives of the Fund, for which the financial support would be the most effective and appropriate. (7) The Fund should express solidarity through financial assistance to Member States. It should enhance the effective management of migration flows to the Union in areas where the Union adds maximum value, in particular by sharing responsibility between Member States and by sharing responsibility and strengthening cooperation with third countries. (8) In order to contribute to the achievement of the general objective of the Fund, Member States should ensure that their national programmes include actions addressing the specific objectives of this Regulation, and that the allocation of resources between objectives ensures that the objectives can be met. In the unusual event that a Member State wishes to derogate from the minimum percentages laid down in this Regulation, the Member State concerned should provide a detailed justification within its national programme. (9) To ensure a uniform and high-quality asylum policy and apply higher standards of international protection, the Fund should contribute to the effective functioning of the Common European Asylum System, which encompasses measures relating to policy, legislation, and capacity-building, while acting in cooperation with other Member States, Union agencies and third countries. (10) It is appropriate to support and improve the efforts made by Member States to fully and properly implement the Union asylum acquis, in particular to grant appropriate reception conditions to displaced persons and applicants for, and beneficiaries of, international protection, to ensure the correct determination of status, in accordance with Directive 2011/95/EU of the European Parliament and of the Council (4), to apply fair and effective asylum procedures and to promote good practice in the field of asylum, so as to protect the rights of persons requiring international protection and enable Member States\u2019 asylum systems to work efficiently. (11) The Fund should offer adequate support to joint efforts by Member States to identify, share and promote best practices and establish effective cooperation structures in order to enhance the quality of decision-making in the framework of the Common European Asylum System. (12) The Fund should complement and reinforce the activities undertaken by the European Asylum Support Office (\u2018EASO\u2019) established by Regulation (EU) No 439/2010 of the European Parliament and of the Council (5), with a view to coordinating practical cooperation between Member States on asylum, supporting Member States subject to particular pressure on their asylum systems and contributing to the implementation of the Common European Asylum System. The Commission may make use of the possibility offered by Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (6) to entrust EASO with the implementation of specific, ad hoc tasks, such as the coordination of Member States\u2019 actions on resettlement in accordance with Regulation (EU) No 439/2010. (13) The Fund should support the efforts by the Union and the Member States relating to the enhancement of the Member States\u2019 capacity to develop, monitor and evaluate their asylum policies in the light of their obligations under existing Union law. (14) The Fund should support the efforts made by Member States to provide international protection and a durable solution in their territories to refugees and displaced persons identified as eligible for resettlement by the United Nations High Commissioner for Refugees (\u2018UNHCR\u2019), such as the assessment of the resettlement needs and transfer of the persons concerned to their territories, with a view to granting them a secure legal status and to promoting their effective integration. (15) The Fund should provide support for new approaches concerning access to asylum procedures in a safer manner, in particular by targeting main countries of transit such as protection programmes for particular groups or certain procedures for examination of applications for asylum. (16) It is in the nature of the Fund that it should be able to provide support to voluntary burden-sharing operations agreed between Member States and consisting of the transfer of beneficiaries of international protection, and of applicants for international protection, from one Member State to another. (17) Partnerships and cooperation with third countries to ensure the adequate management of inflows of persons applying for asylum or other forms of international protection are an essential component of Union asylum policy. With the aim of providing access to international protection and durable solutions at the earliest possible stage, including in the framework of Regional Protection Programmes, the Fund should include a strong Union resettlement component. (18) To improve and reinforce the integration process in European societies, the Fund should facilitate legal migration to the Union in accordance with the economic and social needs of Member States and anticipate the preparation of the integration process already in the country of origin of the third-country nationals coming to the Union. (19) In order to be efficient and achieve the greatest added value, the Fund should pursue a more targeted approach, in support of consistent strategies specifically designed to promote the integration of third-country nationals at national, local and/or regional level, where appropriate. Those strategies should be implemented mainly by local or regional authorities and non-state actors, while not excluding national authorities, in particular where the specific administrative organisation of a Member State would so require, or where, in a Member State, integration actions fall within a competence shared between the State and decentralised administration. The implementing organisations should choose the measures most appropriate to their particular situation from a range of measures available. (20) The implementation of the Fund should be consistent with the Union\u2019s Common Basic Principles on Integration, as specified in the Common Programme for Integration. (21) The scope of the integration measures should also include beneficiaries of international protection in order to ensure a comprehensive approach to integration, taking into account the specificities of those target groups. Where integration measures are combined with reception measures, actions should, where appropriate, also allow applicants for international protection to be included. (22) To ensure the consistency of the Union\u2019s response to the integration of third-country nationals, actions financed under the Fund should be specific and complementary to actions financed under the European Social Fund. In this context, the authorities of the Member States responsible for the implementation of the Fund should be required to establish cooperation and coordination mechanisms with the authorities designated by Member States for the purpose of the management of the interventions of the European Social Fund. (23) For practical reasons, some actions may concern a group of people which can be more efficiently addressed as a whole, without distinguishing between its members. It would therefore be appropriate to provide for the possibility for those Member States that would so wish to provide in their national programmes that integration actions may include immediate relatives of third-country nationals, to the extent that it is necessary for the effective implementation of such actions. The term \u2018immediate relative\u2019 would be understood as meaning spouses, partners, and any person having direct family links in descending or ascending line with the third-country national targeted by the integration action, and who would otherwise not be covered by the scope of the Fund. (24) The Fund should support Member States in setting up strategies organising legal migration, enhancing their capacity to develop, implement, monitor and evaluate in general all immigration and integration strategies, policies and measures for third-country nationals, including Union legal instruments. The Fund should also support the exchange of information, best practices and cooperation between different departments of administration as well as with other Member States. (25) The Union should continue and expand the use of Mobility Partnerships as the main strategic, comprehensive and long-term cooperation framework for migration management with third countries. The Fund should support activities in the framework of Mobility Partnerships taking place either in the Union or in third countries and aimed at pursuing Union needs and priorities, in particular actions ensuring the continuity of funding encompassing both the Union and third countries. (26) It is appropriate to continue supporting and encouraging efforts by the Member States to improve the management of the return of third-country nationals in all its dimensions, with a view to the continuous, fair and effective implementation of common standards on return, in particular as set out in Directive 2008/115/EC of the European Parliament and of the Council (7). The Fund should promote the development of return strategies at national level within the concept of integrated return management, and also measures supporting their effective implementation in third countries. (27) As regards the voluntary return of persons, including persons who wish to be returned even though they are under no obligation to leave the territory, incentives for such returnees, such as preferential treatment in the form of enhanced return assistance, should be envisaged. This kind of voluntary return is in the interests of both returnees and the authorities in terms of its cost-effectiveness. Member States should be encouraged to give preference to voluntary return. (28) However, from a policy point of view, voluntary and enforced return are interlinked and have a mutually reinforcing effect, and Member States should therefore be encouraged in their return management to reinforce the complementarities of the two forms. There is a need to carry out removals in order to safeguard the integrity of the immigration and asylum policy of the Union and the immigration and asylum systems of the Member States. Thus, the possibility of removals is a prerequisite for ensuring that this policy is not undermined and for enforcing the rule of law, which itself is essential to the creation of an area of freedom, security and justice. The Fund should therefore support actions of Member States to facilitate removals in accordance with the standards laid down in Union law, where applicable, and with full respect for the fundamental rights and dignity of returnees. (29) It is essential for the Fund to support specific measures for returnees in the country of return, in order to ensure their effective return to their town or region of origin under good conditions and to enhance their durable reintegration into their community. (30) Union readmission agreements are an integral component of the Union return policy and a central tool for the efficient management of migration flows, as they facilitate the swift return of irregular migrants. Those agreements are an important element in the framework of the dialogue and cooperation with third countries of origin and transit of irregular migrants, and their implementation in third countries should be supported in the interests of effective return strategies at national and Union level. (31) The Fund should complement and reinforce the activities undertaken by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union, established by Council Regulation (EC) No 2007/2004 (8), part of the tasks of which are to provide Member States with the necessary support for organising joint return operations and identifying best practices on the acquisition of travel documents and the removal of illegally staying third-country nationals in the territories of the Member States, as well as to assist Member States in circumstances requiring increased technical and operational assistance at the external borders, taking into account that some situations may involve humanitarian emergencies and rescue at sea. (32) In addition to supporting the return of persons as provided for in this Regulation, the Fund should also support other measures to combat illegal immigration or the circumventing of existing legal migration rules, thereby safeguarding the integrity of Member States\u2019 immigration systems. (33) The Fund should be implemented in full respect for the rights and principles enshrined in the Charter of Fundamental Rights of the European Union and for the fundamental rights enshrined in the relevant international instruments, including the relevant case-law of the European Court of Human Rights. Eligible actions should take account of the human rights-based approach to the protection of migrants, refugees and asylum seekers and should, in particular, ensure that special attention is paid to, and a dedicated response is provided for, the specific situation of vulnerable persons, in particular women, unaccompanied minors and other minors at risk. (34) The terms \u2018vulnerable persons\u2019 and \u2018family members\u2019 are defined differently in different acts relevant for this Regulation. They should therefore be understood in the meaning of the relevant act, bearing in mind the context in which they are used. In the context of resettlement, Member States that resettle should closely consult the UNHCR in relation to the term \u2018family members\u2019 in their resettlement practices and actual resettlement processes. (35) Measures on and in relation to third countries supported through the Fund should be adopted in synergy and in coherence with other actions outside the Union supported through Union external assistance instruments, both geographic and thematic. In particular, in implementing such actions, full coherence should be sought with the principles and general objectives of Union\u2019s external action and foreign policy related to the country or region in question. The measures should not be intended to support actions that are directly oriented towards development and should complement, when appropriate, the financial assistance provided through external aid instruments. The principle of policy coherence for development, as set out in paragraph 35 of the European Consensus on Development, should be respected. It is also important to ensure that the implementation of emergency assistance is consistent with and, where relevant, complementary to the Union\u2019s humanitarian policy and respects humanitarian principles as set out in the European Consensus on Humanitarian Aid. (36) A large part of the available resources under the Fund should be allocated proportionately to the responsibility borne by each Member State through its efforts in managing migration flows on the basis of objective criteria. For that purpose, the latest available statistical data collected by Eurostat under Regulation (EC) No 862/2007 of the European Parliament and of the Council (9) relating to the migration flows, such as the number of first asylum applications, the number of positive decisions granting refugee or subsidiary protection status, the number of resettled refugees, the number of legally residing third-country nationals, the number of third-country nationals who have obtained an authorisation issued by a Member State to reside, the number of return decisions issued by national authorities and the number of effected returns, should be used. (37) The allocation of basic amounts to Member States is laid down by this Regulation. The basic amount is composed of a minimum amount and an amount calculated on the basis of the average of 2011, 2012 and 2013 allocations for each Member State under the European Refugee Fund, established by Decision No 573/2007/EC of the European Parliament and of the Council (10), the European Fund for the Integration of third-country nationals established by Council Decision 2007/435/EC (11) and the European Return Fund established by Decision No 575/2007/EC of the European Parliament and of the Council (12). The calculation of allocations was made in accordance with the distribution criteria laid down in Decision No 573/2007/EC, Decision 2007/435/EC and Decision No 575/2007/EC. In the light of the European Council conclusions of 7-8 February 2013, which underlined that particular emphasis should be given to insular societies who face disproportional migration challenges, it is appropriate to increase the minimum amounts for Cyprus and Malta. (38) Whilst it is appropriate for an amount to be allocated to each Member State on the basis of the latest available statistical data, part of the available resources under the Fund should also be distributed for the implementation of specific actions which require cooperative effort amongst Member States and generate significant added value for the Union, as well as for the implementation of a Union Resettlement Programme and the transfer of beneficiaries of international protection from one Member State to another. (39) For that purpose, this Regulation should establish a list of specific actions eligible for resources from the Fund. Additional amounts should be allocated to those Member States which make a commitment to implement such actions. (40) In the light of the progressive establishment of a Union Resettlement Programme, the Fund should provide targeted assistance in the form of financial incentives (lump sums) for each resettled person. The Commission, in cooperation with the EASO and in accordance with their respective competences, should monitor the effective implementation of resettlement operations supported under the Fund. (41) With a view to increasing the impact of the Union\u2019s resettlement efforts in providing protection to persons in need of international protection and maximising the strategic impact of resettlement through a better targeting of those persons who are in greatest need of resettlement, common priorities with respect to resettlement should be formulated at Union level. Those common priorities should be amended only where there is a clear justification for doing so, or in the light of any recommendations from the UNHCR, on the basis of the general categories specified in this Regulation. (42) Given their particular vulnerability, some categories of persons in need of international protection should always be included in the common Union resettlement priorities. (43) Taking into account the resettlement needs set out in the common Union resettlement priorities, it is also necessary that additional financial incentives are provided for the resettlement of persons with respect to specific geographic regions and nationalities, as well as to the specific categories of persons to be resettled, where resettlement is determined to be the most appropriate response to their special needs. (44) To enhance the solidarity and better share the responsibility between the Member States, in particular towards those most affected by asylum flows, a similar mechanism based on financial incentives should also be established for the transfer of beneficiaries of international protection from one Member State to another. Such a mechanism should reduce the pressure on Member States receiving higher numbers of asylum seekers and beneficiaries of international protection, either in absolute or proportionate terms. (45) The support provided by the Fund will be more efficient and bring greater added value if a limited number of compulsory objectives are identified in this Regulation, to be pursued in the programmes drawn up by each Member State and taking into account its specific situation and needs. (46) It is important for enhanced solidarity that the Fund provides, in coordination and in synergy with the humanitarian assistance managed by the Commission where appropriate, additional support to address emergency situations of heavy migratory pressure in Member States or third countries, or in the event of mass influx of displaced persons, pursuant to Council Directive 2001/55/EC (13), through emergency assistance. Emergency assistance should also include support to ad hoc humanitarian admission programmes aimed at allowing temporary stay on the territory of a Member State in the event of an urgent humanitarian crisis in third countries. However, such other humanitarian admission programmes are without prejudice to, and should not undermine, the Union\u2019s resettlement programme that explicitly aims as from the start to provide a durable solution to persons in need of international protection transferred to the Union from third countries. To that end, Member States should not be entitled to receive additional lump sums in respect of persons granted temporary stay on the territory of a Member State under such other humanitarian admission programmes. (47) This Regulation should provide financial assistance for the activities of the European Migration Network established by Council Decision 2008/381/EC (14), in accordance with its objectives and tasks. (48) Decision 2008/381/EC should therefore be amended to align procedures and to facilitate the provision of appropriate and timely financial support to the National Contact Points that are referred to in that Decision. (49) In the light of the purpose of financial incentives allocated to the Member States for resettlement and/or the transfer of beneficiaries of international protection from one Member State to another in the form of lump sums, and because they represent a small fraction of the actual costs, this Regulation should provide for certain derogations from the rules on the eligibility of expenditure. (50) In order to supplement or amend provisions of this Regulation on lump sums for resettlement and transfer of beneficiaries of international protection from one Member State to another and on the definition of specific actions and of common Union resettlement priorities, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (51) In the application of this Regulation, including the preparation of delegated acts, the Commission should consult experts from all Member States. (52) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (15). (53) Funding from the Union budget should concentrate on activities where the Union intervention can bring additional value compared to the action of Member States alone. As the Union is in a better position than Member States to provide a framework for expressing Union solidarity in the management of migration flows, financial support provided under this Regulation should contribute, in particular, to strengthening national and Union capabilities in this area. (54) There is a need to maximise the impact of Union funding by mobilising, pooling and leveraging public and private financial resources. (55) The Commission should monitor the implementation of the Fund in accordance with Regulation (EU) No 514/2014 of the European Parliament and of the Council (16), with the aid of common indicators for evaluating results and impacts. Those indicators, including relevant baselines, should provide the minimum basis for evaluating the extent to which the objectives of the Fund have been achieved. (56) In order to measure the achievements of the Fund, common indicators should be established in relation to each of its specific objectives. The common indicators should not affect the optional or mandatory nature of the implementation of related actions as laid down in this Regulation. (57) For the purpose of its management and implementation, the Fund should form part of a coherent framework consisting of this Regulation and Regulation (EU) No 513/2014 of the European Parliament and of the Council (17). For the purposes of the Fund, the partnership provided for in Regulation (EU) No 514/2014 should include relevant international organisations, non-governmental organisations and social partners. Each Member State should be responsible for establishing the composition of the partnership and the practical arrangements concerning its implementation. (58) Since the objective of this Regulation, namely contributing to the efficient management of migration flows and to the implementation, strengthening and development of the common policy on asylum, subsidiary protection and temporary protection and the common immigration policy, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (59) Pursuant to Articles 8 and 10 TFEU, the Fund should take account of the mainstreaming of equality between women and men and anti-discrimination principles. (60) Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC should be repealed, subject to the transitional provisions set out in this Regulation. (61) In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, those Member States have notified their wish to take part in the adoption and application of this Regulation. (62) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (63) It is appropriate to align the period of application of this Regulation with that of Council Regulation (EU, Euratom) No 1311/2013 (18). Therefore, this Regulation should apply as from 1 January 2014, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Purpose and scope 1. This Regulation establishes the Asylum, Migration and Integration Fund (\u2018the Fund\u2019) for the period from 1 January 2014 to 31 December 2020. 2. This Regulation lays down: (a) the objectives of financial support and the eligible actions; (b) the general framework for the implementation of eligible actions; (c) the available financial resources and their distribution; (d) the principles and mechanism for the establishment of common Union resettlement priorities; and (e) the financial assistance provided for the activities of the European Migration Network. 3. This Regulation provides for the application of the rules set out in Regulation (EU) No 514/2014, without prejudice to Article 4 of this Regulation. Article 2 Definitions For the purpose of this Regulation, the following definitions apply: (a) \u2018resettlement\u2019 means the process whereby, on a request from the United Nations High Commissioner for Refugees (\u2018UNHCR\u2019) based on a person\u2019s need for international protection, third-country nationals are transferred from a third country and established in a Member State where they are permitted to reside with one of the following statuses: (i) \u2018refugee status\u2019 within the meaning of point (e) of Article 2 of Directive 2011/95/EU; (ii) \u2018subsidiary protection status\u2019 within the meaning of point (g) of Article 2 of Directive 2011/95/EU; or (iii) any other status which offers similar rights and benefits under national and Union law as those referred to in points (i) and (ii); (b) \u2018other humanitarian admission programmes\u2019 means an ad hoc process whereby a Member State admits a number of third-country nationals to stay on its territory for a temporary period of time in order to protect them from urgent humanitarian crises due to events such as political developments or conflicts; (c) \u2018international protection\u2019 means refugee status and subsidiary protection status within the meaning of Directive 2011/95/EU; (d) \u2018return\u2019 means the process of a third-country national going back, whether in voluntary compliance with an obligation to return or enforced, as defined in Article 3 of Directive 2008/115/EC; (e) \u2018third-country national\u2019 means any person who is not a citizen of the Union within the meaning of Article 20(1) TFEU. Reference to third-country nationals shall be understood to include stateless persons and persons with undetermined nationality; (f) \u2018removal\u2019 means the enforcement of the obligation to return, namely the physical transportation out of the Member State, as defined in Article 3 of Directive 2008/115/EC; (g) \u2018voluntary departure\u2019 means compliance with the obligation to return within the time-limit fixed for that purpose in the return decision, as defined in Article 3 of Directive 2008/115/EC; (h) \u2018unaccompanied minor\u2019 means a third-country national below the age of 18 years, who arrives or arrived on the territory of a Member State unaccompanied by an adult responsible for him/her whether by law or the national practice of the Member State concerned, and for as long as he/she is not effectively taken into the care of such a person; it includes a minor who is left unaccompanied after he/she entered the territory of a Member State; (i) \u2018vulnerable person\u2019 means any third-country national who complies with the definition under Union law relevant to the policy area of action supported under the Fund; (j) \u2018family member\u2019 means any third-country national who complies with the definition under Union law relevant to the policy area of action supported under the Fund; (k) \u2018emergency situation\u2019 means a situation resulting from: (i) heavy migratory pressure in one or more Member States characterised by a large and disproportionate inflow of third-country nationals, which places significant and urgent demands on their reception and detention facilities, asylum systems and procedures; (ii) the implementation of temporary protection mechanisms within the meaning of Directive 2001/55/EC; or (iii) heavy migratory pressure in third countries where refugees are stranded due to events such as political developments or conflicts. Article 3 Objectives 1. The general objective of the Fund shall be to contribute to the efficient management of migration flows and to the implementation, strengthening and development of the common policy on asylum, subsidiary protection and temporary protection and the common immigration policy, while fully respecting the rights and principles enshrined in the Charter of Fundamental Rights of the European Union. 2. Within its general objective, the Fund shall contribute to the following common specific objectives: (a) to strengthen and develop all aspects of the Common European Asylum System, including its external dimension; (b) to support legal migration to the Member States in accordance with their economic and social needs, such as labour market needs, while safeguarding the integrity of the immigration systems of Member States, and to promote the effective integration of third-country nationals; (c) to enhance fair and effective return strategies in the Member States which contribute to combating illegal immigration, with an emphasis on sustainability of return and effective readmission in the countries of origin and transit; (d) to enhance solidarity and responsibility-sharing between the Member States, in particular towards those most affected by migration and asylum flows, including through practical cooperation. The achievement of the specific objectives of the Fund shall be evaluated in accordance with Article 55(2) of Regulation (EU) No 514/2014 using common indicators as set out in Annex IV to this Regulation and programme-specific indicators included in national programmes. 3. Measures taken to achieve the objectives referred to in paragraphs 1 and 2 shall be fully coherent with measures supported through the external financing instruments of the Union and with the principles and general objectives of the Union\u2019s external action. 4. The objectives referred to in paragraphs 1 and 2 of this Article shall be achieved with due regard to the principles and objectives of the Union\u2019s humanitarian policy. Consistency with the measures funded by the Union\u2019s external financing instruments shall be ensured in accordance with Article 24. Article 4 Partnership For the purposes of the Fund, the partnership referred to in Article 12 of Regulation (EU) No 514/2014 shall include relevant international organisations, non-governmental organisations and social partners. CHAPTER II COMMON EUROPEAN ASYLUM SYSTEM Article 5 Reception and asylum systems 1. Within the specific objective laid down in point (a) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes laid down in Article 19 of this Regulation, the Fund shall support actions focusing on one or more of the following categories of third-country nationals: (a) those who enjoy refugee status or subsidiary protection status within the meaning of Directive 2011/95/EU; (b) those who have applied for one of the forms of international protection referred to in point (a) and have not yet received a final decision; (c) those who enjoy temporary protection within the meaning of Directive 2001/55/EC; (d) those who are being or have been resettled in or transferred from a Member State. As regards reception conditions and asylum procedures, the Fund shall support, in particular, the following actions focusing on the categories of persons referred to in the first subparagraph of this paragraph: (a) the provision of material aid, including assistance at the border, education, training, support services, health and psychological care; (b) the provision of support services such as translation and interpretation, education, training, including language training, and other initiatives which are consistent with the status of the person concerned; (c) the setting-up and improvement of administrative structures, systems and training for staff and relevant authorities to ensure effective and easy access to asylum procedures for asylum seekers and efficient and high-quality asylum procedures, in particular, where necessary, to support the development of the Union acquis; (d) the provision of social assistance, information or help with administrative and/or judicial formalities and information or counselling on the possible outcomes of the asylum procedure, including on aspects such as return procedures; (e) the provision of legal assistance and representation; (f) the identification of vulnerable groups and specific assistance for vulnerable persons, in particular in accordance with points (a) to (e); (g) the establishment, development and improvement of alternative measures to detention. Where deemed appropriate, and where the national programme of a Member State provides for them, the Fund may also support integration-related measures, such as those referred to in Article 9(1), concerning the reception of persons referred to in the first subparagraph of this paragraph. 2. Within the specific objective defined in point (a) of the first subparagraph of Article 3(2), and in line with the objectives of the national programmes defined in Article 19, as regards accommodation infrastructure and reception systems, the Fund shall support, in particular, the following actions: (a) the improvement and maintenance of existing accommodation infrastructure and services; (b) the strengthening and improvement of administrative structures and systems; (c) information for local communities; (d) the training of the staff of authorities, including local authorities, who will be interacting with the persons referred to in paragraph 1 in the context of their reception; (e) the establishment, running and development of new accommodation infrastructure and services, as well as administrative structures and systems, in particular, where necessary, to address the structural needs of Member States. 3. Within the specific objectives laid down in points (a) and (d) of the first subparagraph of Article 3(2), and in accordance with the objectives of the national programmes defined in Article 19, the Fund shall also support actions similar to those listed in paragraph 1 of this Article, where such actions are related to persons who are temporarily staying: \u2014 in transit and processing centres for refugees, in particular to support resettlement operations in cooperation with the UNHCR, or \u2014 on the territory of a Member State in the context of other humanitarian admission programmes. Article 6 Member States\u2019 capacity to develop, monitor and evaluate their asylum policies and procedures Within the specific objective laid down in point (a) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, as regards actions relating to the enhancement of Member States\u2019 capacity to develop, monitor and evaluate their asylum policies and procedures, the Fund shall support, in particular, the following actions: (a) actions enhancing the capacity of Member States \u2014 including in relation to the mechanism for early warning, preparedness and crisis management established in Regulation (EU) No 604/2013 of the European Parliament and of the Council (19) \u2014 to collect, analyse and disseminate qualitative and quantitative data and statistics on asylum procedures, reception capacities, resettlement and the transfer of applicants for and/or beneficiaries of international protection from one Member State to another; (b) actions enhancing the capacity of Member States to collect, analyse and disseminate country-of-origin information; (c) actions directly contributing to the evaluation of asylum policies, such as national impact assessments, surveys amongst target groups and other relevant stakeholders, and to the development of indicators and benchmarking. Article 7 Resettlement, transfer of applicants for, and beneficiaries of, international protection and other ad hoc humanitarian admission 1. Within the specific objective laid down in points (a) and (d) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall support, in particular, the following actions related to resettlement of any third country national who is being resettled or has been resettled in a Member State, and other humanitarian admission programmes: (a) the establishment and development of national resettlement programmes and strategies and other humanitarian admission programmes, including needs analysis, improvement of indicators and evaluation; (b) the establishment of appropriate infrastructure and services to ensure the smooth and effective implementation of resettlement actions and actions concerning other humanitarian admission programmes, including language assistance; (c) the setting up of structures, systems and training of staff to conduct missions to the third countries and/or other Member States, to carry out interviews and to conduct medical and security screening; (d) the assessment of potential resettlement cases and/or cases of other humanitarian admission by the competent Member States\u2019 authorities, such as conducting missions to the third country, carrying out interviews and conducting medical and security screening; (e) pre-departure health assessment and medical treatment, pre-departure material provisions, pre-departure information and integration measures and travel arrangements, including the provision of medical escort services; (f) information and assistance upon arrival or shortly thereafter, including interpretation services; (g) actions for family reunification purposes for persons being resettled in a Member State; (h) the strengthening of infrastructure and services relevant to migration and asylum in the countries designated for the implementation of Regional Protection Programmes; (i) creating conditions conducive to the integration, autonomy and self-reliance of resettled refugees on a long-term basis. 2. Within the specific objective laid down in point (d) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of the Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall also support actions similar to those listed in paragraph 1 of this Article, where deemed appropriate in the light of policy developments within the implementation period of the Fund or where the national programme of a Member State makes such provisions, in relation to the transfer of applicants for and/or beneficiaries of international protection. Such operations shall be carried out with their consent from the Member State which granted them international protection or is responsible for examining their application to another interested Member State where they will be granted equivalent protection or where their application for international protection will be examined. CHAPTER III INTEGRATION OF THIRD-COUNTRY NATIONALS AND LEGAL MIGRATION Article 8 Immigration and pre-departure measures Within the specific objective laid down in point (b) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall support actions taking place in a third country which focus on third-country nationals who comply with specific pre-departure measures and/or conditions set out in national law and in accordance with Union law where applicable, including those relating to the ability to integrate in the society of a Member State. In this context, the Fund shall support, in particular, the following actions: (a) information packages and campaigns to raise awareness and promote intercultural dialogue, including via user-friendly communication and information technology and websites; (b) the assessment of skills and qualifications, as well as enhancement of transparency and compatibility of skills and qualifications in a third country with those of a Member State; (c) training enhancing employability in a Member State; (d) comprehensive civic orientation courses and language tuition; (e) assistance in the context of applications for family reunification within the meaning of Council Directive 2003/86/EC (20). Article 9 Integration measures 1. Within the specific objective laid down in point (b) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall support actions which take place in the framework of consistent strategies, taking into account the integration needs of third-country nationals at local and/or regional level. In this context, the Fund shall support, in particular, the following actions focusing on third-country nationals who are residing legally in a Member State or, where appropriate, who are in the process of acquiring legal residence in a Member State: (a) setting up and developing such integration strategies with the participation of local or regional actors, where appropriate, including needs analysis, the improvement of integration indicators, and evaluation, including participatory assessments, in order to identify best practices; (b) providing advice and assistance in areas such as housing, means of subsistence, administrative and legal guidance, health, psychological and social care, child care and family reunification; (c) actions introducing third-country nationals to the receiving society and actions enabling them to adapt to it, to inform them about their rights and obligations, to participate in civil and cultural life and to share the values enshrined in the Charter of Fundamental Rights of the European Union; (d) measures focusing on education and training, including language training and preparatory actions to facilitate access to the labour market; (e) actions designed to promote self-empowerment and to enable third-country nationals to provide for themselves; (f) actions that promote meaningful contact and constructive dialogue between third-country nationals and the receiving society, and actions to promote acceptance by the receiving society, including through the involvement of the media; (g) actions promoting both equality of access and equality of outcomes in relation to third-country nationals\u2019 dealings with public and private services, including adaptation of those services to dealing with third-country nationals; (h) capacity-building of beneficiaries, as defined in point (g) of Article 2 of Regulation (EU) No 514/2014, including through exchanges of experience and best practices, and networking. 2. The actions referred to in paragraph 1 shall, wherever necessary, take into account the specific needs of different categories of third-country nationals, including beneficiaries of international protection, resettled or transferred persons and, in particular, vulnerable persons. 3. National programmes may allow for the inclusion in the actions referred to in paragraph 1 of immediate relatives of persons covered by the target group referred to in that paragraph, to the extent that it is necessary for the effective implementation of such actions. 4. For the purpose of programming and implementation of the actions referred to in paragraph 1 of this Article, the partnership referred to in Article 12 of Regulation (EU) No 514/2014 shall include the authorities designated by Member States for the purpose of the management of the interventions of the European Social Fund. Article 10 Practical cooperation and capacity-building measures Within the specific objective laid down in point (b) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of the Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall support actions focusing on one or more of the following: (a) building up strategies promoting legal migration with a view to facilitating the development and implementation of flexible admission procedures; (b) supporting cooperation between third countries and the recruitment agencies, the employment services and the immigration services of Member States, as well as supporting Member States in their implementation of Union migration law, consultation processes with relevant stakeholders and expert advice or information exchanges on approaches which target specific nationalities or categories of third-country nationals with respect to the needs of the labour markets; (c) reinforcing the capacity of Member States to develop, implement, monitor and evaluate their immigration strategies, policies and measures across the different levels and departments of administrations, in particular enhancing their capacity to collect, analyse and disseminate detailed and systematic data and statistics on migration procedures and flows and residence permits, and develop monitoring tools, evaluation schemes, indicators and benchmarking for measuring the achievement of those strategies; (d) training of beneficiaries as defined in point (g) of Article 2 of Regulation (EU) No 514/2014 and of staff providing public and private services, including educational institutions, promoting the exchange of experiences and best practices, cooperation and networking, and intercultural capacities, as well as improving the quality of services provided; (e) building sustainable organisational structures for integration and diversity management, in particular through cooperation between different stakeholders enabling officials at various levels of national administrations to swiftly acquire information about experiences and best practices elsewhere and, where possible, to pool resources between relevant authorities as well as between governmental and non-governmental bodies to provide services to third-country nationals more effectively, inter alia, through one-stop-shops (i.e. coordinated integration-support centres); (f) contributing to a dynamic two-way process of mutual interaction, underlying integration strategies at local and regional level by developing platforms for the consultation of third-country nationals, exchanges of information among stakeholders and intercultural and religious dialogue platforms between third-country nationals\u2019 communities, between those communities and the receiving society and/or between those communities and policy and decision-making authorities; (g) actions to promote and reinforce the practical cooperation between the relevant authorities of Member States, with a focus on, inter alia, exchanges of information, best practices and strategies, and the development and implementation of joint actions, including with a view to safeguarding the integrity of the immigration systems of Member States. CHAPTER IV RETURN Article 11 Measures accompanying return procedures Within the specific objective laid down in point (c) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, as regards measures accompanying return procedures, the Fund shall focus on one or more of the following categories of third-country nationals: (a) third-country nationals who have not yet received a final negative decision in relation to their request to stay, their legal residence and/or international protection in a Member State, and who may choose to make use of voluntary return; (b) third-country nationals enjoying the right to stay, legal residence and/or international protection within the meaning of Directive 2011/95/EU, or temporary protection within the meaning of Directive 2001/55/EC in a Member State, and who have chosen to make use of voluntary return; (c) third-country nationals who are present in a Member State and do not or no longer fulfil the conditions for entry and/or stay in a Member State, including those third-country nationals whose removal has been postponed in accordance with Article 9 and Article 14(1) of Directive 2008/115/EC. In this context, the Fund shall support, in particular, the following actions focusing on the categories of persons referred to in the first subparagraph: (a) the introduction, development and improvement of alternative measures to detention; (b) the provision of social assistance, information or help with administrative and/or judicial formalities and information or counselling; (c) the provision of legal aid and language assistance; (d) specific assistance for vulnerable persons; (e) the introduction and improvement of independent and effective systems for monitoring enforced return, as laid down in Article 8(6) of Directive 2008/115/EC; (f) the establishment, maintenance and improvement of accommodation, reception or detention infrastructure, services and conditions; (g) the setting-up of administrative structures and systems, including IT tools; (h) the training of staff to ensure smooth and effective return procedures, including their management and implementation. Article 12 Return measures Within the specific objective laid down in point (c) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, as regards return measures the Fund shall support actions focusing on the persons referred to in Article 11 of this Regulation. In this context, the Fund shall support, in particular, the following actions: (a) measures necessary for the preparation of return operations, such as those leading to the identification of third-country nationals, to the issuing of travel documents and to family tracing; (b) cooperation with the consular authorities and immigration services of third countries with a view to obtaining travel documents, facilitating repatriation and ensuring readmission; (c) assisted voluntary return measures, including medical examinations and assistance, travel arrangements, financial contributions and pre- and post-return counselling and assistance; (d) removal operations, including related measures, in accordance with the standards laid down in Union law, with the exception of coercive equipment; (e) measures to launch the progress of reintegration for the returnee\u2019s personal development, such as cash-incentives, training, placement and employment assistance and start-up support for economic activities; (f) facilities and services in third countries ensuring appropriate temporary accommodation and reception upon arrival; (g) specific assistance for vulnerable persons. Article 13 Practical cooperation and capacity-building measures Within the specific objective laid down in point (c) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, as regards practical cooperation and capacity-building measures the Fund shall support, in particular, the following actions: (a) actions to promote, develop and reinforce operational cooperation and information exchange between the return services and other authorities of Member States involved in return, including as regards cooperation with the consular authorities and immigration services of third countries and joint return operations; (b) actions to support cooperation between third countries and the return services of Member States, including measures aiming to strengthen third countries\u2019 capacities to conduct readmission and reintegration activities, in particular in the framework of readmission agreements; (c) actions enhancing the capacity to develop effective and sustainable return policies, in particular by exchanging information on the situation in countries of return, best practices, sharing experiences and pooling resources between Member States; (d) actions enhancing the capacity to collect, analyse and disseminate detailed and systematic data and statistics on return procedures and measures, reception and detention capacities, enforced and voluntary returns, monitoring and reintegration; (e) actions directly contributing to the evaluation of return policies, such as national impact assessments, surveys amongst target groups, the development of indicators and benchmarking; (f) information measures and campaigns in third countries aimed at raising awareness of the appropriate legal channels for immigration and the risks of illegal immigration. CHAPTER V FINANCIAL AND IMPLEMENTATION FRAMEWORK Article 14 Global resources and implementation 1. The global resources for the implementation of this Regulation shall be EUR 3 137 million in current prices. 2. The annual appropriations for the Fund shall be authorised by the European Parliament and the Council within the limits of the multiannual financial framework. 3. The global resources shall be implemented through the following means: (a) national programmes, in accordance with Article 19; (b) Union actions, in accordance with Article 20; (c) emergency assistance, in accordance with Article 21; (d) the European Migration Network, in accordance with Article 22; (e) technical assistance, in accordance with Article 23. 4. The budget allocated under this Regulation to Union actions referred to in Article 20 of this Regulation, to the emergency assistance referred to in Article 21 of this Regulation, to the European Migration Network referred to in Article 22 of this Regulation and to the technical assistance referred to in Article 23 of this Regulation shall be implemented under direct management in accordance with point (a) of Article 58(1) of Regulation (EU, Euratom) No 966/2012 and, where appropriate, under indirect management in accordance with point (c) of Article 58(1) of Regulation (EU, Euratom) No 966/2012. The budget allocated to national programmes referred to in Article 19 of this Regulation shall be implemented under shared management in accordance with point (b) of Article 58(1) of Regulation (EU, Euratom) No 966/2012. 5. The Commission shall remain responsible for the implementation of the Union budget in accordance with Article 317 TFEU and shall inform the European Parliament and the Council of the operations carried out by entities other than Member States. 6. Without prejudice to the prerogatives of the European Parliament and of the Council, the prime reference financial envelope shall be used indicatively as follows: (a) EUR 2 752 million for national programmes of Member States; (b) EUR 385 million for Union actions, emergency assistance, the European Migration Network and technical assistance of the Commission, of which at least 30 % shall be used for Union actions and the European Migration Network. Article 15 Resources for eligible actions in the Member States 1. The amount of EUR 2 752 million shall be allocated to the Member States indicatively as follows: (a) EUR 2 392 million shall be allocated as indicated in Annex I. Member States shall allocate at least 20 % of those resources to the specific objective referred to in point (a) of the first subparagraph of Article 3(2), and at least 20 % to the specific objective referred to in point (b) of the first subparagraph of Article 3(2). Member States may depart from those minimum percentages only where a detailed explanation is included in the national programme as to why allocating resources below this level does not jeopardise the achievement of the objective. As far as the specific objective referred to in point (a) of the first subparagraph of Article 3(2) is concerned, those Member States faced with structural deficiencies in the area of accommodation, infrastructure and services shall not fall below the minimum percentage laid down in this Regulation; (b) EUR 360 million shall be allocated on the basis of the distribution mechanism for specific actions as referred to in Article 16, for the Union Resettlement Programme as referred to Article 17, and for the transfer of beneficiaries of international protection from one Member State to another as referred to in Article 18. 2. The amount referred to in point (b) of paragraph 1 shall support: (a) specific actions listed in Annex II; (b) the Union Resettlement Programme in accordance with Article 17 and/or transfers of beneficiaries of international protection from one Member State to another in accordance with Article 18. 3. In the event that an amount remains available under point (b) of paragraph 1 of this Article or that another amount is available, it will be allocated in the framework of the mid-term review laid down in Article 15 of Regulation (EU) No 514/2014 pro-rata to the basic amounts for national programmes established in Annex I to this Regulation. Article 16 Resources for specific actions 1. An additional amount as referred to in point (a) of Article 15(2) may be allocated to the Member States, provided that it is earmarked as such in the programme and that it is used to implement the specific actions listed in Annex II. 2. To take into account new policy developments, the Commission shall be empowered to adopt delegated acts in accordance with Article 26 of this Regulation to revise Annex II in the context of the mid-term review referred to in Article 15 of Regulation (EU) No 514/2014. On the basis of the revised list of specific actions, Member States may receive an additional amount as laid down in paragraph 1 of this Article, subject to available resources. 3. The additional amounts referred to in paragraphs 1 and 2 of this Article shall be allocated to the Member States in the individual financing decisions approving or revising their national programmes in the context of the mid-term review according to the procedure laid down in Articles 14 and 15 of Regulation (EU) No 514/2014. Those amounts shall only be used for the implementation of the specific actions listed in Annex II to this Regulation. Article 17 Resources for the Union Resettlement Programme 1. Member States shall, in addition to their allocation calculated in accordance with point (a) of Article 15(1), receive every two years an additional amount as set out in point (b) of Article 15(2) based on a lump sum of EUR 6 000 for each resettled person. 2. The lump sum referred to in paragraph 1 shall be increased to EUR 10 000 for each person resettled in accordance with the common Union resettlement priorities established pursuant to paragraph 3 and listed in Annex III and for each vulnerable person as laid down in paragraph 5. 3. The common Union resettlement priorities shall be based on the following general categories of persons: (a) persons from a country or region designated for the implementation of a Regional Protection Programme; (b) persons from a country or region which has been identified in the UNHCR resettlement forecast and where Union common action would have a significant impact on addressing the protection needs; (c) persons belonging to a specific category falling within the UNHCR resettlement criteria. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 26 to amend Annex III, on the basis of the general categories set out in paragraph 3 of this Article, where there is a clear justification for doing so or in the light of any recommendations from the UNHCR. 5. The following vulnerable groups of persons shall also qualify for the lump sum provided for in paragraph 2: (a) women and children at risk; (b) unaccompanied minors; (c) persons having medical needs that can be addressed only through resettlement; (d) persons in need of emergency resettlement or urgent resettlement for legal or physical protection needs, including victims of violence or torture. 6. Where a Member State resettles a person belonging to more than one of the categories referred to in paragraphs 1 and 2, it shall receive the lump sum for that person only once. 7. Where appropriate, Member States may also be eligible for lump sums for family members of persons referred to in paragraphs 1, 3 and 5, provided that those family members have been resettled in accordance with this Regulation. 8. The Commission shall establish, by way of implementing acts, the timetable and other implementation conditions related to the allocation mechanism of resources for the Union Resettlement Programme. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 27(2). 9. The additional amounts referred to in paragraphs 1 and 2 of this Article shall be allocated to the Member States every two years, for the first time in the individual financing decisions approving their national programme in accordance with the procedure laid down in Article 14 of Regulation (EU) No 514/2014, and later in a financing decision to be annexed to the decisions approving their national programme. Those amounts shall not be transferred to other actions under the national programme. 10. To effectively pursue the objectives of the Union Resettlement Programme and within the limits of available resources, the Commission shall be empowered to adopt delegated acts in accordance with Article 26 to adjust, if deemed appropriate, the lump sums referred to in paragraphs 1 and 2 of this Article, in particular taking into account the current rates of inflation, relevant developments in the field of resettlement, as well as factors which can optimise the use of the financial incentive brought by the lump sums. Article 18 Resources for the transfer of beneficiaries of international protection 1. With a view to implementing the principle of solidarity and fair sharing of responsibility and in the light of Union policy developments within the implementation period of the Fund, Member States shall receive, in addition to their allocation calculated in accordance with point (a) of Article 15(1), an additional amount as set out in point (b) of Article 15(2) based on a lump sum of EUR 6 000 for each beneficiary of international protection transferred from another Member State. 2. Member States may also be eligible for lump sums for family members of persons referred to in paragraph 1, where appropriate, provided that those family members have been transferred in accordance with this Regulation. 3. The additional amounts referred to in paragraph 1 of this Article shall be allocated to the Member States for the first time in the individual financing decisions approving their national programme in accordance with the procedure laid down in Article 14 of Regulation (EU) No 514/2014 and later in a financing decision to be annexed to the decision approving their national programme. Those amounts shall not be transferred to other actions under the national programme. 4. To effectively pursue the objectives of solidarity and responsibility sharing between the Member States referred to in Article 80 TFEU, and within the limits of available resources, the Commission shall be empowered to adopt delegated acts in accordance with Article 26 of this Regulation to adjust the lump sum referred to in paragraph 1 of this Article, in particular taking into account the current rates of inflation, relevant developments in the field of transfer of beneficiaries of international protection from one Member State to another, as well as factors which can optimise the use of the financial incentive brought by the lump sums. Article 19 National programmes 1. Under the national programmes to be examined and approved in accordance with Article 14 of Regulation (EU) No 514/2014, Member States shall, within the objectives laid down in Article 3 of this Regulation, and taking account of the outcome of the policy dialogue referred to in Article 13 of Regulation (EU) No 514/2014, pursue in particular the following objectives: (a) strengthening the establishment of the Common European Asylum System by ensuring the efficient and uniform application of the Union acquis on asylum and the proper functioning of Regulation (EU) No 604/2013. Such actions may also include the establishment and development of the Union Resettlement Programme; (b) setting up and developing integration strategies, encompassing different aspects of the two-way dynamic process, to be implemented at national/local/regional level where appropriate, taking into account the integration needs of third-country nationals at local/regional level, addressing specific needs of different categories of migrants and developing effective partnerships between relevant stakeholders; (c) developing a return programme, which includes a component on assisted voluntary return and, where appropriate, on reintegration. 2. Member States shall ensure that all actions supported under the Fund shall be implemented in full compliance with fundamental rights and respect for human dignity. In particular, such actions shall fully respect the rights and principles enshrined in the Charter of Fundamental Rights of the European Union. 3. Subject to the requirement to pursue the above objectives and taking into account their individual circumstances, Member States shall aim to achieve a fair and transparent distribution of resources among the specific objectives set out in Article 3(2). Article 20 Union actions 1. At the Commission\u2019s initiative, the Fund may be used to finance transnational actions or actions of particular interest to the Union (\u2018Union actions\u2019), concerning the general and specific objectives referred to in Article 3. 2. To be eligible for funding, Union actions shall, in particular, support: (a) the furthering of Union cooperation in implementing Union law and in sharing best practices in the field of asylum, notably on resettlement and the transfer of applicants for and/or beneficiaries of international protection from one Member State to another, including through networking and exchanging information, on legal migration, on integration of third-country nationals, including arrival support and coordination activities to promote resettlement with the local communities that are to welcome resettled refugees, and on return; (b) the setting-up of transnational cooperation networks and pilot projects, including innovative projects, based on transnational partnerships between bodies located in two or more Member States designed to stimulate innovation and to facilitate exchanges of experiences and best practices; (c) studies and research on possible new forms of Union cooperation in the field of asylum, immigration, integration and return and relevant Union law, the dissemination and exchange of information on best practices and on all other aspects of asylum, immigration, integration and return policies, including corporate communication on the political priorities of the Union; (d) the development and application by Member States of common statistical tools, methods and indicators for measuring policy developments in the field of asylum, legal migration and integration and return; (e) preparatory, monitoring, administrative and technical support and the development of an evaluation mechanism required to implement the policies on asylum and immigration; (f) cooperation with third countries on the basis of the Union\u2019s Global Approach to Migration and Mobility, in particular in the framework of the implementation of readmission agreements, Mobility Partnerships and Regional Protection Programmes; (g) information measures and campaigns in third countries aimed at raising awareness of appropriate legal channels for immigration and the risks of illegal immigration. 3. Union actions shall be implemented in accordance with Article 6 of Regulation (EU) No 514/2014. 4. The Commission shall ensure a fair and transparent distribution of resources among the objectives referred to in Article 3(2). Article 21 Emergency assistance 1. The Fund shall provide financial assistance to address urgent and specific needs in the event of an emergency situation, as defined in point (k) of Article 2. Measures implemented in third countries in accordance with this Article shall be consistent with and, where relevant, complementary to the Union humanitarian policy and respect humanitarian principles as set out in the Consensus on Humanitarian Aid. 2. Emergency assistance shall be implemented in accordance with Articles 6 and 7 of Regulation (EU) No 514/2014. Article 22 European Migration Network 1. The Fund shall support the European Migration Network and provide the financial assistance necessary for its activities and its future development. 2. The amount made available for the European Migration Network under the annual appropriations of the Fund and the work programme laying down the priorities for its activities shall be adopted by the Commission, after approval by the Steering Board, in accordance with the procedure referred to in point (a) of Article 4(5) of Decision 2008/381/EC. The decision of the Commission shall constitute a financing decision pursuant to Article 84 of Regulation (EU, Euratom) No 966/2012. 3. Financial assistance provided for the activities of the European Migration Network shall take the form of grants to the National Contact Points referred to in Article 3 of Decision 2008/381/EC and public contracts as appropriate, in accordance with Regulation (EU, Euratom) No 966/2012. The assistance shall ensure appropriate and timely financial support to those National Contact Points. Costs incurred for the implementation of actions of those National Contact Points supported through grants awarded in 2014 may be eligible from 1 January 2014. 4. Decision 2008/381/EC is amended as follows: (a) point (a) of Article 4(5) is replaced by the following: \u2018(a) prepare and approve the draft work programme of activities, notably with regard to the objectives, thematic priorities and indicative amounts of the budget for each National Contact Point to ensure the proper functioning of the EMN, on the basis of a draft from the Chair;\u2019; (b) Article 6 is amended as follows: (i) paragraph 4 is replaced by the following: \u20184. The Commission shall monitor the execution of the work programme of activities and regularly report on its execution and on the development of the EMN to the Steering Board.\u2019; (ii) paragraphs 5 to 8 are deleted; (c) Article 11 is deleted; (d) Article 12 is deleted. Article 23 Technical assistance 1. At the initiative and/or on behalf of the Commission, up to EUR 2,5 million of the Fund shall be annually used for technical assistance in accordance with Article 9 of Regulation (EU) No 514/2014. 2. At the initiative of a Member State, the Fund may finance technical assistance activities, in accordance with Article 20 of Regulation (EU) No 514/2014. The amount set aside for technical assistance shall not exceed, for the period 2014-2020, 5,5 % of the total amount allocated to a Member State plus EUR 1 000 000. Article 24 Coordination The Commission and the Member States, together with the European External Action Service where appropriate, shall ensure that actions in and in relation to third countries are taken in synergy and in coherence with other actions outside the Union supported through Union instruments. They shall, in particular, ensure that those actions: (a) are coherent with the Union\u2019s external policy, respect the principle of policy coherence for development and are consistent with the strategic programming documents for the region or country in question; (b) focus on non-development-oriented measures; (c) serve the interests of the Union\u2019s internal policies and are consistent with activities undertaken inside the Union. CHAPTER VI FINAL PROVISIONS Article 25 Specific provisions concerning lump sums for resettlement and transfer of beneficiaries of international protection from one Member State to another By way of derogation from the rules on the eligibility of expenditure laid down in Article 18 of Regulation (EU) No 514/2014, in particular as regards the lump sums and flat rates, the lump sums allocated to the Member States for resettlement and/or the transfer of beneficiaries of international protection from one Member State to another pursuant to this Regulation shall be: (a) exempt from the obligation that they are to be based on statistical or historic data; and (b) granted provided that the person in respect of whom the lump sum is allocated was effectively resettled and/or transferred in accordance with this Regulation. Article 26 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 16(2), Article 17(4) and (10) and Article 18(4) shall be conferred on the Commission for a period of seven years from 21 May 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of powers shall be tacitly extended for a period of three years, unless the European Parliament or the Council opposes such extension not later than three months before the end of the seven-year period. 3. The delegation of power referred to in Article 16(2), Article 17(4) and (10) and Article 18(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 16(2), Article 17(4) and (10) and Article 18(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 27 Committee procedure 1. The Commission shall be assisted by the \u2018Asylum, Migration and Integration and Internal Security Funds Committee\u2019 established by Article 59(1) of Regulation (EU) No 514/2014. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 28 Review The European Parliament and the Council shall, on the basis of a proposal of the Commission, review this Regulation by 30 June 2020. Article 29 Applicability of Regulation (EU) No 514/2014 The provisions of Regulation (EU) No 514/2014 shall apply to the Fund, without prejudice to Article 4 of this Regulation. Article 30 Repeal Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC are repealed with effect from 1 January 2014. Article 31 Transitional provisions 1. This Regulation shall not affect the continuation or modification, including the total or partial cancellation, of the projects and annual programmes concerned, until their closure, or of the financial assistance approved by the Commission on the basis of Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC or any other legislation applying to that assistance on 31 December 2013. This Regulation shall not affect the continuation or modification, including the total or partial cancellation, of financial support approved by the Commission on the basis of Decision 2008/381/EC or any other legislation applying to that assistance on 31 December 2013. 2. When adopting decisions on co-financing under this Regulation, the Commission shall take account of measures adopted on the basis of Decisions No 573/2007/EC, No 575/2007/EC, 2007/435/EC and 2008/381/EC before 20 May 2014 which have financial repercussions during the period covered by that co-financing. 3. Sums committed for co-financing approved by the Commission between 1 January 2011 and 31 December 2014 for which the documents required for closure of the actions have not been sent to the Commission by the deadline for submitting the final report shall be automatically decommitted by the Commission by 31 December 2017, giving rise to the repayment of amounts unduly paid. 4. Amounts relating to actions which have been suspended due to legal proceedings or administrative appeals having suspensive effect shall be disregarded in calculating the amount to be automatically decommitted. 5. By 30 June 2015, Member States shall submit to the Commission evaluation reports on the results and impact of actions co-financed under Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC concerning the period 2011-2013. 6. By 31 December 2015, the Commission shall submit to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions ex-post evaluation reports under Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC concerning the period 2011-2013. Article 32 Entry into force and application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 16 April 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 299, 4.10.2012, p. 108. (2) OJ C 277, 13.9.2012, p. 23. (3) Position of the European Parliament of 13 March 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014. (4) Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted (OJ L 337, 20.12.2011, p. 9). (5) Regulation (EU) No 439/2010 of the European Parliament and of the Council of 19 May 2010 establishing a European Asylum Support Office (OJ L 132, 29.5.2010, p. 11). (6) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (7) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (8) Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 349, 25.11.2004, p. 1). (9) Regulation (EC) No 862/2007 of the European Parliament and of the Council of 11 July 2007 on Community statistics on migration and international protection and repealing Council Regulation (EEC) No 311/76 on the compilation of statistics on foreign workers (OJ L 199, 31.7.2007, p. 23). (10) Decision No 573/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the European Refugee Fund for the period 2008 to 2013 as part of the General programme \u2018Solidarity and Management of Migration Flows\u2019 and repealing Council Decision 2004/904/EC (OJ L 144, 6.6.2007, p. 1). (11) Council Decision 2007/435/EC of 25 June 2007 establishing the European Fund for the Integration of third-country nationals for the period 2007 to 2013 as part of the General programme \u2018Solidarity and Management of Migration Flows\u2019 (OJ L 168, 28.6.2007, p. 18). (12) Decision No 575/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the European Return Fund for the period 2008 to 2013 as part of the General Programme \u2018Solidarity and Management of Migration Flows\u2019 (OJ L 144, 6.6.2007, p. 45). (13) Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof (OJ L 212, 7.8.2001, p. 12). (14) Council Decision 2008/381/EC of 14 May 2008 establishing a European Migration Network (OJ L 131, 21.5.2008, p. 7). (15) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (16) Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (see page 112 of this Official Journal). (17) Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA (see page 93 of this Official Journal). (18) Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, p. 884). (19) Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person (OJ L 180, 29.6.2013, p. 31). (20) Council Directive 2003/86/EC of 22 September 2003 on the right to family reunification (OJ L 251, 3.10.2003, p. 12). ANNEX I Multiannual breakdowns per Member State for the period 2014-2020 (in EUR) Member State Minimum amount % average 2011-2013 allocations ERF+IF+RF Average amount 2011-2013 TOTAL AT 5 000 000 2,65 % 59 533 977 64 533 977 BE 5 000 000 3,75 % 84 250 977 89 250 977 BG 5 000 000 0,22 % 5 006 777 10 006 777 CY 10 000 000 0,99 % 22 308 677 32 308 677 CZ 5 000 000 0,94 % 21 185 177 26 185 177 DE 5 000 000 9,05 % 203 416 877 208 416 877 EE 5 000 000 0,23 % 5 156 577 10 156 577 ES 5 000 000 11,22 % 252 101 877 257 101 877 FI 5 000 000 0,82 % 18 488 777 23 488 777 FR 5 000 000 11,60 % 260 565 577 265 565 577 GR 5 000 000 11,32 % 254 348 877 259 348 877 HR 5 000 000 0,54 % 12 133 800 17 133 800 HU 5 000 000 0,83 % 18 713 477 23 713 477 IE 5 000 000 0,65 % 14 519 077 19 519 077 IT 5 000 000 13,59 % 305 355 777 310 355 777 LT 5 000 000 0,21 % 4 632 277 9 632 277 LU 5 000 000 0,10 % 2 160 577 7 160 577 LV 5 000 000 0,39 % 8 751 777 13 751 777 MT 10 000 000 0,32 % 7 178 877 17 178 877 NL 5 000 000 3,98 % 89 419 077 94 419 077 PL 5 000 000 2,60 % 58 410 477 63 410 477 PT 5 000 000 1,24 % 27 776 377 32 776 377 RO 5 000 000 0,75 % 16 915 877 21 915 877 SE 5 000 000 5,05 % 113 536 877 118 536 877 SI 5 000 000 0,43 % 9 725 477 14 725 477 SK 5 000 000 0,27 % 5 980 477 10 980 477 UK 5 000 000 16,26 % 365 425 577 370 425 577 MS Totals 145 000 000 100,00 % 2 247 000 000 2 392 000 000 ANNEX II List of specific actions referred to in Article 16 1. Establishment and development in the Union of transit and processing centres for refugees, in particular to support resettlement operations in cooperation with the UNHCR. 2. New approaches, in cooperation with the UNHCR, concerning access to asylum procedures targeting main countries of transit, such as protection programmes for particular groups or certain procedures for examination of applications for asylum. 3. Joint initiatives amongst Member States in the field of integration, such as benchmarking exercises, peer reviews or testing of European modules, for example on the acquisition of language skills or the organisation of introductory programmes and with the aim of improving the coordination of policies between Member States, regions and local authorities. 4. Joint initiatives aimed at the identification and implementation of new approaches concerning the procedures at first encounter and standards of protection of and assistance for unaccompanied minors. 5. Joint return operations, including joint actions on the implementation of Union readmission agreements. 6. Joint reintegration projects in the countries of origin with a view to sustainable return, as well as joint actions to strengthen third countries\u2019 capacities to implement Union readmission agreements. 7. Joint initiatives aimed at restoring family unity and reintegration of unaccompanied minors in their countries of origin. 8. Joint initiatives among Member States in the field of legal migration, including the setting up of joint migration centres in third countries, as well as joint projects to promote cooperation between Member States with a view to encouraging the use of exclusively legal migration channels and informing about the risks of illegal immigration. ANNEX III List of common Union resettlement priorities 1. The Regional Protection Programme in Eastern Europe (Belarus, Moldova, Ukraine). 2. The Regional Protection Programme in the Horn of Africa (Djibouti, Kenya, Yemen). 3. The Regional Protection Programme in North Africa (Egypt, Libya, Tunisia). 4. Refugees in the region of Eastern Africa/Great Lakes. 5. Iraqi refugees in Syria, Lebanon, Jordan. 6. Iraqi refugees in Turkey. 7. Syrian refugees in the region. ANNEX IV List of common indicators for the measurement of the specific objectives (a) To strengthen and develop all aspects of the Common European Asylum System, including its external dimension. (i) Number of target group persons provided with assistance through projects in the field of reception and asylum systems supported under the Fund. For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as: \u2014 number of target group persons benefiting from information and assistance throughout the asylum procedures, \u2014 number of target group persons benefiting from legal assistance and representation, \u2014 number of vulnerable persons and unaccompanied minors benefiting from specific assistance; (ii) Capacity (i.e. number of places) of new reception accommodation infrastructure set up in line with the common requirements for reception conditions set out in the Union acquis and of existing reception accommodation infrastructure improved in accordance with the same requirements as a result of the projects supported under the Fund and percentage in the total reception accommodation capacity; (iii) Number of persons trained in asylum-related topics with the assistance of the Fund, and that number as a percentage of the total number of staff trained in those topics; (iv) Number of country-of-origin information products and fact-finding missions conducted with the assistance of the Fund; (v) Number of projects supported under the Fund to develop, monitor and evaluate asylum policies in Member States; (vi) Number of persons resettled with support of the Fund. (b) To support legal migration to the Member States in accordance with their economic and social needs, such as labour market needs, while reducing the abuse of legal migration, and to promote the effective integration of third-country nationals. (i) Number of target group persons who participated in pre-departure measures supported under the Fund; (ii) Number of target group persons assisted by the Fund through integration measures in the framework of national, local and regional strategies. For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as: \u2014 number of target group persons assisted through measures focusing on education and training, including language training and preparatory actions to facilitate access to the labour market, \u2014 number of target group persons supported through the provision of advice and assistance in the area of housing, \u2014 number of target group persons assisted through the provision of health and psychological care, \u2014 number of target group persons assisted through measures related to democratic participation; (iii) Number of local, regional and national policy frameworks/measures/tools in place for the integration of third-country nationals and involving civil society and migrant communities, as well as all other relevant stakeholders, as a result of the measures supported under the Fund; (iv) Number of cooperation projects with other Member States on the integration of third-country nationals supported under the Fund; (v) Number of projects supported under the Fund to develop, monitor and evaluate integration policies in Member States. (c) To enhance fair and effective return strategies in the Member States supporting the fight against illegal immigration with an emphasis on sustainability of return and effective readmission in the countries of origin and transit. (i) Number of persons trained on return-related topics with the assistance of the Fund; (ii) Number of returnees who received pre or post return reintegration assistance co-financed by the Fund; (iii) Number of returnees whose return was co-financed by the Fund, persons who returned voluntarily and persons who were removed; (iv) Number of monitored removal operations co-financed by the Fund; (v) Number of projects supported under the Fund to develop, monitor and evaluate return policies in Member States. (d) To enhance the solidarity and responsibility sharing between the Member States, in particular towards those most affected by migration and asylum flows. (i) Number of applicants and beneficiaries of international protection transferred from one Member State to another with support of the Fund; (ii) Number of cooperation projects with other Member States on enhancing solidarity and responsibility sharing between the Member States supported under the Fund.", "summary": "Asylum, Migration and Integration Fund (AMIF) Asylum, Migration and Integration Fund (AMIF) SUMMARY OF: Regulation (EU) No 516/2014 on establishing the Asylum, Migration and Integration Fund WHAT IS THE AIM OF THE REGULATION? This regulation establishes the Asylum, Migration and Integration Fund. This fund aims to contribute to the efficient management of migration flows and improve the implementation and development of the common policy on immigration and asylum of the European Union (EU). The EU\u2019s Asylum, Migration and Integration Fund (AMIF) has 4 main objectives: strengthening and developing all aspects of the Common European Asylum System, including its external dimension; supporting legal migration to the EU Member States in accordance with their economic and social needs, such as labour market needs, and promoting the effective integration of nationals from non-EU countries; enhancing return strategies in the Member States, with an emphasis on the sustainability of return and effective readmission in the countries of origin; enhancing solidarity and the sharing of responsibility between the Member States, in particular for those most affected by migration and asylum flows. KEY POINTS All Member States (except Denmark, which is not participating in this fund) prepare national programmes outlining the actions through which they intend to achieve the objectives set out in the AMIF regulation. Examples of actions include measures to support: reception and asylum systems (such as improved administrative structures, training of staff dealing with asylum procedures and developing alternatives to detention); integration measures, with a focus on the local level (such as the provision of training and services to non-EU nationals and the sharing of best practices among EU Member States); voluntary return programmes, reintegration measures, etc. While most of the fund\u2019s budget is allocated to the national programmes, part of it is used for EU-level actions (\u2018Union actions\u2019), emergency assistance, the European Migration Network and technical assistance at the initiative of the European Commission. Specific actions In addition to their national programme allocation, Member States may receive an additional amount for the implementation of specific actions. These actions (listed in Annex II), require Member States to cooperate with each other and generate significant added value for the EU. Union resettlement programme Each Member State may also receive, every 2 years, an additional amount based on a lump sum of \u20ac6,000 for each resettled person, which will be increased to \u20ac10,000 for common priorities (such as regional protection programmes) and vulnerable groups of persons. Budget The financial envelope for the implementation of the fund for 2014-2020 was initially set at \u20ac3.137 billion, which has been more than doubled over the financial period 2014-2020, mainly due to the migration crisis in 2015-2016. Details regarding the implementation of the fund are to be found in Regulation (EU) No 514/2014 (see summary). FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND For more information, see: Asylum, Migration and Integration fund (2014-2020) (European Commission). MAIN DOCUMENT Regulation (EU) No 516/2014 of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC (OJ L 150, 20.5.2014, pp. 168\u2013194) Successive amendments to Regulation (EU) No 516/2014 have been incorporated into the basic text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2020/445 of 15 October 2019 amending Annex II to Regulation (EU) No 516/2014 of the European Parliament and of the Council establishing the Asylum, Migration and Integration Fund (OJ L 94, 27.3.2020, pp. 1\u20132) Regulation (EU) 2018/2000 of the European Parliament and of the Council of 12 December 2018 amending Regulation (EU) No 516/2014 of the European Parliament and of the Council, as regards the recommitment of the remaining amounts committed to support the implementation of Council Decisions (EU) 2015/1523 and (EU) 2015/1601 or the allocation of those amounts to other actions under the national programmes (OJ L 328, 21.12.2018, pp. 78\u201381) Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 150, 20.5.2014, pp. 112\u2013142) last update 03.09.2021"}
{"article": "20.5.2014 EN Official Journal of the European Union L 150/93 REGULATION (EU) No 513/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 82(1), 84 and 87(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Union\u2019s objective of ensuring a high level of security within an area of freedom, security and justice pursuant to Article 67(3) of the Treaty on the Functioning of the European Union (TFEU) should be achieved, inter alia, through measures to prevent and combat crime as well as through measures for coordination and cooperation between law enforcement authorities and other national authorities of Member States, including with Europol or other relevant Union bodies, and with relevant third countries and international organisations. (2) To achieve this objective, enhanced actions at Union level should be taken to protect people and goods from increasingly transnational threats and to support the work carried out by Member States\u2019 competent authorities. Terrorism, organised crime, itinerant crime, drug trafficking, corruption, cybercrime, trafficking in human beings and arms, inter alia, continue to challenge the internal security of the Union. (3) The Internal Security Strategy for the European Union (\u2018Internal Security Strategy\u2019), adopted by the Council in February 2010, constitutes a shared agenda for tackling these common security challenges. The Commission Communication of 22 November 2010 entitled \u2018The EU Internal Security Strategy in Action: Five steps toward a more secure Europe\u2019 translates the strategy\u2019s principles and guidelines into concrete actions by identifying five strategic objectives: to disrupt international crime networks, to prevent terrorism and address radicalisation and recruitment, to raise levels of security for citizens and businesses in cyberspace, to strengthen security through border management and to increase Europe\u2019s resilience in the face of crises and disasters. (4) Solidarity among Member States, clarity about the division of tasks, respect for fundamental rights and freedoms and the rule of law, a strong focus on the global perspective and on the link and the necessary coherence with external security should be key principles guiding the implementation of the Internal Security Strategy. (5) To promote the implementation of the Internal Security Strategy and to ensure that it becomes an operational reality, Member States should be provided with adequate Union financial support by setting up and managing an Internal Security Fund (\u2018the Fund\u2019). (6) The Fund should reflect the need for increased flexibility and simplification while respecting requirements in terms of predictability, and ensuring a fair and transparent distribution of resources to meet the general and specific objectives laid down in this Regulation. (7) Efficiency of measures and quality of spending constitute guiding principles in the implementation of the Fund. Furthermore, the Fund should also be implemented in the most effective and user-friendly manner possible. (8) In times of austerity for Union policies, overcoming economic problems requires renewed flexibility, innovative organisational measures, better use of existing structures, and coordination between the Union\u2019s institutions, agencies and national authorities and with third countries. (9) There is a need to maximise the impact of Union funding by mobilising, pooling and leveraging public and private financial resources. (10) The EU policy cycle established by the Council on 8-9 November 2010 aims at tackling the most important serious and organised criminal threats to the Union in a coherent and methodical manner through optimum cooperation between the relevant services. In order to support an effective implementation of this multiannual cycle, funding under the instrument established by this Regulation (the \u2018Instrument\u2019) should make use of all possible methods of implementation as set out in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (4), including, where appropriate, by indirect management, to ensure the timely and efficient delivery of the activities and projects. (11) Due to the legal particularities applicable to Title V TFEU, it is not possible to establish the Fund as a single financial instrument. The Fund should therefore be established as a comprehensive framework for Union financial support in the field of internal security comprising the Instrument and the instrument for financial support for external borders and visa established by Regulation (EU) No 515/2014 of the European Parliament and of the Council (5). That comprehensive framework should be complemented by Regulation (EU) No 514/2014 of the European Parliament and of the Council (6). (12) Cross-border crime such as human trafficking and exploitation of illegal immigration by criminal organisations may be tackled effectively through police cooperation. (13) The global resources for this Regulation and for Regulation (EU) No 515/2014 jointly lay down the financial envelope for the entire duration of the Fund, which is to constitute the prime reference amount within the meaning of point 17 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (7), for the European Parliament and the Council during the annual budgetary procedure. (14) The European Parliament resolution of 23 October 2013 on organised crime, corruption and money laundering recognised that the fight against organised crime is a European challenge and called for more cooperation between Member States in the law enforcement field, as tackling organised crime effectively is fundamental to protecting the lawful economy from typical criminal activities such as the laundering of the proceeds of crime. (15) Within the comprehensive framework of the Fund, the financial assistance provided under the Instrument should support police cooperation, exchange of and access to information, crime prevention, the fight against cross-border, serious and organised crime including terrorism, corruption, drug trafficking, trafficking in human beings and arms, exploitation of illegal immigration, child sexual exploitation, distribution of child abuse images and child pornography, cybercrime, laundering of the proceeds of crime, the protection of people and critical infrastructure against security-related incidents and the effective management of security-related risks and crises, taking into account common policies (strategies, policy cycles, programmes and action plans), legislation and practical cooperation. (16) Financial assistance in these areas should in particular support actions promoting cross-border joint operations, access to and exchange of information, exchange of best practices, facilitated and secure communication and coordination, training and exchange of staff, analytical, monitoring and evaluation activities, comprehensive threat and risk assessments in accordance with the competencies set out in the TFEU, awareness raising activities, testing and validation of new technology, forensic science research, the acquisition of technical interoperable equipment and cooperation between Member States and relevant Union bodies, including Europol. Financial assistance in these areas should only support actions which are consistent with priorities and initiatives identified at Union level, in particular those that have been endorsed by the European Parliament and the Council. (17) Within the comprehensive framework of the Union\u2019s anti-drugs strategy that advocates a balanced approach based on a simultaneous reduction in supply and demand, the financial assistance provided under this Instrument should support all actions aimed at preventing and combating trafficking in drugs (supply reduction), and in particular measures targeting the production, manufacture, extraction, sale, transport, importation and exportation of illegal drugs, including possession and purchase, with a view to engaging in drug trafficking activities. (18) Measures in and in relation to third countries supported through the Instrument should be adopted in synergy and coherence with other actions outside the Union supported through Union external assistance instruments, both geographic and thematic. In particular, in implementing such actions, full coherence should be sought with the principles and general objectives of Union external action and foreign policy related to the country or region in question, democratic principles and values, fundamental liberties and rights, the rule of law and the sovereignty of third countries. The measures should not be intended to support directly development-oriented actions and should complement, when appropriate, the financial assistance provided through external aid instruments. Coherence should also be sought with Union humanitarian policy, in particular as regards the implementation of emergency measures. (19) The Instrument should be implemented in full respect for the rights and principles enshrined in the Charter of Fundamental Rights of the European Union and for the Union\u2019s international obligations. (20) Pursuant to Article 3 of the Treaty on European Union (TEU), the Instrument should support activities which ensure the protection of children against violence, abuse, exploitation and neglect. The Instrument should also support safeguards and assistance for child witnesses and victims, in particular those who are unaccompanied or otherwise in need of guardianship. (21) The Instrument should complement and reinforce the activities undertaken to develop cooperation between Europol or other relevant Union bodies and Member States in order to achieve the objectives of the Instrument in the field of police cooperation, preventing and combating crime, and crisis management. This means, inter alia, that, when drawing up their national programmes, Member States should take into account the information database, analytical tools and operational and technical guidelines developed by Europol, in particular the Europol information system (EIS), the Europol Secure Information Exchange Network Application (SIENA) and the EU Serious and Organised Crime Threat Assessment (SOCTA). (22) In order to ensure a uniform implementation of the Fund, the Union budget allocated to the Instrument should be implemented by direct and indirect management in respect of actions of particular interest to the Union (\u2018Union actions\u2019), emergency assistance and technical assistance, and by shared management in respect of national programmes and actions requiring administrative flexibility. (23) For the resources implemented under shared management, it is necessary to ensure that the Member States\u2019 national programmes are consistent with Union priorities and objectives. (24) The resources allocated to Member States for implementation through their national programmes should be established in this Regulation and distributed on the basis of clear, objective and measurable criteria. Those criteria should relate to the public goods to be protected by Member States and the degree of their financial capacity to ensure a high level of internal security, such as the size of their population, their territorial size and their gross domestic product. Moreover, since SOCTA of 2013 points out the prevalent importance of sea and air ports as entry points for criminal organisations for trafficking in human beings and illegal commodities, specific vulnerabilities represented by crime routes at these external crossings should be reflected in the distribution of available resources for actions undertaken by Member States through criteria relating to the number of passengers and weight of cargo processed through international air and seaports. (25) To reinforce solidarity and responsibility sharing for common Union policies, strategies and programmes, Member States should be encouraged to use a part of the global resources available for the national programmes to address the strategic Union priorities set out in Annex I to this Regulation. For projects addressing those priorities, the Union contribution to their total eligible cost should be increased to 90 %, in accordance with Regulation (EU) No 514/2014. (26) The ceiling for resources which remain at the disposal of the Union should be complementary to the resources allocated to Member States for the implementation of their national programmes. That will ensure that the Union is able, in a given budget year, to support actions which are of particular interest to the Union, such as studies, testing and validation of new technologies, transnational projects, networking and exchange of best practices, monitoring of the implementation of relevant Union law and Union policies and actions in relation to and in third countries. The actions supported should be in line with the priorities identified in relevant Union strategies, programmes, action plans and risk and threat assessments. (27) In order to contribute to the achievement of the general objective of the Instrument, Member States should ensure that their national programmes include actions addressing all the specific objectives of the Instrument and that the allocation of resources between the objectives is proportionate to the challenges and needs and ensures that the objectives can be met. Where a national programme does not address one of the specific objectives or the allocation is below the minimum percentages set in this Regulation, the Member State concerned should provide a justification within the programme. (28) In order to strengthen the Union\u2019s capacity to react immediately to security-related incidents or newly emerging threats to the Union, it should be possible to provide emergency assistance in accordance with the framework set out in Regulation (EU) No 514/2014. (29) Funding from the Union budget should concentrate on activities where Union intervention can bring added value compared with action by Member States alone. As the Union is in a better position than Member States to address cross-border situations and to provide a platform for common approaches, activities eligible for support under this Regulation should contribute in particular to strengthening national and Union capabilities as well as cross-border cooperation and coordination, networking, mutual trust and the exchange of information and best practices. (30) In order to supplement or amend provisions in this Regulation regarding the definition of strategic Union priorities, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending, adding or deleting strategic Union priorities listed in this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (31) In the application of this Regulation, including the preparation of delegated acts, the Commission should consult experts from all Member States. (32) The Commission should monitor the implementation of the Instrument, in accordance with the relevant provisions of Regulation (EU) No 514/2014, with the aid of key indicators for evaluating results and impacts. The indicators, including relevant baselines, should provide the minimum basis for evaluating the extent to which the objectives of the Instrument have been achieved. (33) In order to measure the achievements of the Fund, common indicators should be established in relation to each specific objective of the Instrument. The measurement of the achievement of the specific objectives by means of common indicators does not render the implementation of actions related to those indicators mandatory. (34) Council Decision 2007/125/JHA (8) should be repealed, subject to the transitional provisions set out in this Regulation. (35) Since the objectives of this Regulation, namely strengthening coordination and cooperation between law enforcement authorities, preventing and combating crime, protecting people and critical infrastructure against security-related incidents and enhancing the capacity of Member States and the Union to manage effectively security-related risks and crises, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (36) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (37) In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, Ireland has notified its wish to take part in the adoption and application of this Regulation. (38) In accordance with Articles 1 and 2 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, the United Kingdom is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (39) It is appropriate to align the period of application of this Regulation with that of Council Regulation (EU, Euratom) No 1311/2013 (9). Therefore, this Regulation should apply as from 1 January 2014, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Purpose and scope 1. This Regulation establishes the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (\u2018the Instrument\u2019), as part of the Internal Security Fund (\u2018the Fund\u2019). Jointly with Regulation (EU) No 515/2014, this Regulation establishes the Fund for the period from 1 January 2014 to 31 December 2020. 2. This Regulation lays down: (a) the objectives, eligible actions and strategic priorities for financial support to be provided under the Instrument; (b) the general framework for the implementation of the eligible actions; (c) the resources made available under the Instrument from 1 January 2014 to 31 December 2020 and their distribution. 3. This Regulation provides for the application of the rules set out in Regulation (EU) No 514/2014. 4. The Instrument shall not apply to matters that are covered by the Justice programme, as set out in Regulation (EU) No 1382/2013 of the European Parliament and of the Council (10). However the Instrument may cover actions which aim at encouraging cooperation between judicial authorities and law enforcement authorities. 5. Synergies, consistency and complementarity shall be sought with other relevant financial instruments of the Union, such as the Union Civil Protection Mechanism, established by Decision No 1313/2013/EU of the European Parliament and of the Council (11), Horizon 2020, established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council (12), the third multiannual programme of Union action in the field of health, established by Regulation (EU) No 282/2014 of the European Parliament and of the Council (13), the European Union Solidarity Fund and the external aid instruments, namely the Instrument for Pre-accession Assistance (IPA II) established by Regulation (EU) No 231/2014 of the European Parliament and of the Council (14), the European Neighbourhood Instrument established by Regulation (EU) No 232/2014 of the European Parliament and of the Council (15), the Development Cooperation Instrument established by Regulation (EU) No 233/2014 of the European Parliament and of the Council (16), the Partnership Instrument for cooperation with third countries established by Regulation (EU) No 234/2014 of the European Parliament and of the Council (17), the European Instrument for Democracy and Human Rights established by Regulation (EU) No 235/2014 of the European Parliament and of the Council (18) and the Instrument contributing to Stability and Peace established by Regulation (EU) No 230/2014 of the European Parliament and of the Council (19). Actions financed under this Regulation shall not receive financial support for the same purpose from other Union financial instruments. Article 2 Definitions For the purpose of this Regulation, the following definitions shall apply: (a) \u2018police cooperation\u2019 means the specific measures and types of cooperation involving all the Member States\u2019 competent authorities as referred to in Article 87 TFEU; (b) \u2018exchange of and access to information\u2019 means the secure collection, storage, processing, analysis and exchange of information relevant to the authorities as referred to in Article 87 TFEU in relation to the prevention, detection, investigation, and prosecution of criminal offences, in particular cross-border, serious and organised crime; (c) \u2018crime prevention\u2019 means all measures that are intended to reduce or otherwise contribute to reducing crime and citizens\u2019 feeling of insecurity, as referred to in Article 2(2) of Council Decision 2009/902/JHA (20); (d) \u2018organised crime\u2019 means punishable conduct relating to participation in a criminal organisation, as defined in Council Framework Decision 2008/841/JHA (21); (e) \u2018terrorism\u2019 means any of the intentional acts and offences as defined in Council Framework Decision 2002/475/JHA (22); (f) \u2018risk and crisis management\u2019 means any measure relating to the assessment, prevention, preparedness and consequence management of terrorism, organised crime and other security-related risks; (g) \u2018prevention and preparedness\u2019 means any measure aimed at preventing and/or reducing risks linked to possible terrorist attacks or other security-related incidents; (h) \u2018consequence management\u2019 means the effective coordination of actions taken at national and/or Union level in order to react to and to reduce the impact of the effects of a terrorist attack or any other security-related incident; (i) \u2018critical infrastructure\u2019 means an asset, network, system or part thereof which is essential for the maintenance of vital societal functions, health, safety, security, economic or social well-being of people, and the disruption, breach or destruction of which would have a significant impact in a Member State or in the Union as a result of the failure to maintain those functions; (j) \u2018emergency situation\u2019 means any security-related incident or newly emerging threat which has or may have a significant adverse impact on the security of people in one or more Member States. Article 3 Objectives 1. The general objective of the Instrument shall be to contribute to ensuring a high level of security in the Union. 2. Within the general objective set out in paragraph 1, the Instrument shall contribute \u2014 in accordance with the priorities identified in relevant Union strategies, policy cycles, programmes, threat and risk assessments \u2014 to the following specific objectives: (a) crime prevention, combating cross-border, serious and organised crime including terrorism, and reinforcing coordination and cooperation between law enforcement authorities and other national authorities of Member States, including with Europol or other relevant Union bodies, and with relevant third countries and international organisations; (b) enhancing the capacity of Member States and the Union for managing effectively security-related risks and crises, and preparing for and protecting people and critical infrastructure against terrorist attacks and other security-related incidents. The achievement of the specific objectives of the Instrument shall be evaluated in accordance with Article 55(2) of Regulation (EU) No 514/2014 using common indicators, as set out in Annex II to this Regulation and programme-specific indicators included in national programmes. 3. To achieve the objectives referred to in paragraphs 1 and 2, the Instrument shall contribute to the following operational objectives: (a) promote and develop measures strengthening Member States\u2019 capability to prevent crime and combat cross-border, serious and organised crime including terrorism, in particular through public-private partnerships, exchange of information and best practices, access to data, interoperable technologies, comparable statistics, applied criminology, public communication and awareness raising; (b) promote and develop administrative and operational coordination, cooperation, mutual understanding and exchange of information among Member States\u2019 law enforcement authorities, other national authorities, Europol or other relevant Union bodies and, where appropriate, with third countries and international organisations; (c) promote and develop training schemes, including regarding technical and professional skills and knowledge of obligations relating to respect for human rights and fundamental freedoms, in implementation of European training policies, including through specific Union law enforcement exchange programmes, in order to foster a genuine European judicial and law enforcement culture; (d) promote and develop measures, safeguards, mechanisms and best practices for early identification, protection and support of witnesses and victims of crime, including victims of terrorism, and in particular for child witnesses and victims, especially those who are unaccompanied or otherwise in need of guardianship; (e) measures strengthening Member States\u2019 administrative and operational capability to protect critical infrastructure in all sectors of economic activity, including through public-private partnerships and improved coordination, cooperation, exchange and dissemination of know-how and experience within the Union and with relevant third countries; (f) secure links and effective coordination between existing sector-specific early warning and crisis cooperation actors at Union and national level, including situation centres in order to enable the quick production of comprehensive and accurate overviews in crisis situations, coordinate response measures and share open, privileged and classified information; (g) measures strengthening the administrative and operational capacity of the Member States and the Union to develop comprehensive threat and risk assessments, which are evidence based and consistent with priorities and initiatives identified at Union level, in particular those that have been endorsed by the European Parliament and the Council, in order to enable the Union to develop integrated approaches based on common and shared appreciations in crisis situations and to enhance mutual understanding of Member States\u2019 and partner countries\u2019 various definitions of threat levels. 4. The Instrument shall also contribute to the financing of technical assistance at the initiative of the Member States and the Commission. 5. Actions funded under the Instrument shall be implemented in full respect for fundamental rights and human dignity. In particular, actions shall comply with the provisions of the Charter of Fundamental Rights of the European Union, Union data protection law and the European Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR). In particular, wherever possible, special attention shall be given by Member States when implementing actions to the assistance and protection of vulnerable persons, in particular children and unaccompanied minors. Article 4 Eligible actions under national programmes 1. Within the objectives referred to in Article 3 of this Regulation, in the light of the agreed conclusions of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014 and in accordance with the objectives of the national programme referred to in Article 7 of this Regulation, the Instrument shall support actions in Member States, and in particular those from the following list: (a) actions improving police cooperation and coordination between law enforcement authorities, including with and between relevant Union bodies, in particular Europol and Eurojust, joint investigation teams and any other form of cross-border joint operation, access to and exchange of information and interoperable technologies; (b) projects promoting networking, public-private partnerships, mutual confidence, understanding and learning, the identification, exchange and dissemination of know-how, experience and best practices, information sharing, shared situation awareness and foresight, contingency planning and interoperability; (c) analytical, monitoring and evaluation activities, including studies and threat, risk and impact assessments, which are evidence based and consistent with priorities and initiatives identified at Union level, in particular those that have been endorsed by the European Parliament and the Council; (d) awareness raising, dissemination and communication activities; (e) acquisition, maintenance of Union IT systems and national IT systems contributing to the achievement of the objectives of this Regulation, and/or further upgrading of IT systems and technical equipment, including testing compatibility of systems, secure facilities, infrastructures, related buildings and systems, especially information and communication technology (ICT) systems and their components, including for the purpose of European cooperation on cyber security and cyber crime, notably with the European Cybercrime Centre; (f) exchange, training and education of staff and experts of relevant authorities, including language training and joint exercises or programmes; (g) measures deploying, transferring, testing and validating new methodology or technology, including pilot projects and follow-up measures to Union funded security research projects. 2. Within the objectives referred to in Article 3, the Instrument may also support the following actions in relation to and in third countries: (a) actions improving police cooperation and coordination between law enforcement authorities, including joint investigation teams and any other form of cross-border joint operation, access to and exchange of information and interoperable technologies; (b) networking, mutual confidence, understanding and learning, the identification, exchange and dissemination of know-how, experience and best practices, information sharing, shared situation awareness and foresight, contingency planning and interoperability; (c) exchange, training and education of staff and experts of relevant authorities. The Commission and the Member States, together with the European External Action Service, shall ensure coordination as regards actions in and in relation to third countries, as set out in Article 3(5) of Regulation (EU) No 514/2014. CHAPTER II FINANCIAL AND IMPLEMENTATION FRAMEWORK Article 5 Global resources and implementation 1. The global resources for the implementation of the Instrument shall be EUR 1 004 million in current prices. 2. Annual appropriations shall be authorised by the European Parliament and the Council within the limits of the multiannual financial framework. 3. The global resources shall be implemented through the following means: (a) national programmes, in accordance with Article 7; (b) Union actions, in accordance with Article 8; (c) technical assistance, in accordance with Article 9; (d) emergency assistance, in accordance with Article 10. 4. The budget allocated under the Instrument to Union actions referred to in Article 8 of this Regulation, to the technical assistance referred to in Article 9 of this Regulation and to the emergency assistance referred to in Article 10 of this Regulation shall be implemented under direct management and indirect management in accordance, respectively, with points (a) and (c) of Article 58(1) of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (23). The budget allocated to the national programmes referred to in Article 7 of this Regulation shall be implemented under shared management in accordance with point (b) of Article 58(1) of Regulation (EU, Euratom) No 966/2012. 5. Without prejudice to the prerogatives of the European Parliament and the Council, the global resources shall be used as follows: (a) EUR 662 million for the national programmes of Member States; (b) EUR 342 million for Union actions, emergency assistance and technical assistance at the initiative of the Commission. 6. Each Member State shall allocate the amounts for national programmes indicated in Annex III as follows: (a) at least 20 % for actions relating to the specific objective referred to in point (a) of the first subparagraph of Article 3(2); and (b) at least 10 % for actions relating to the specific objective referred to in point (b) of the first subparagraph of Article 3(2). Member States may depart from those minimum percentages provided that an explanation is included in the national programmes as to why allocating resources below that level does not jeopardise the achievement of the relevant objective. That explanation will be assessed by the Commission in the context of its approval of national programmes as referred to in Article 7(2). 7. Jointly with the global resources established for Regulation (EU) No 515/2014, the global resources available for the Instrument, as established in paragraph 1 of this Article, constitute the financial envelope for the Fund and serve as the prime reference, within the meaning of point 17 of the Interinstitutional Agreement between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, for the European Parliament and the Council during the annual budgetary procedure. Article 6 Resources for eligible actions in the Member States 1. EUR 662 million shall be allocated to the Member States as follows: (a) 30 % in proportion to the size of their total population; (b) 10 % in proportion to the size of their territory; (c) 15 % in proportion to the number of passengers and 10 % to the tons of cargo processed through their international air and sea ports; (d) 35 % in inverse proportion to their gross domestic product (purchasing power standard per inhabitant). 2. The reference figures for the data referred to in paragraph 1 shall be the latest statistics produced by the Commission (Eurostat), on the basis of data provided by Member States in accordance with Union law. The reference date is 30 June 2013. The allocations for national programmes calculated on the basis of the criteria referred to in paragraph 1 are set out in Annex III. Article 7 National programmes 1. The national programme to be prepared under the Instrument and the one to be prepared under Regulation (EU) No 515/2014 shall be proposed to the Commission as one single national programme for the Fund, in accordance with Article 14 of Regulation (EU) No 514/2014. 2. Under the national programmes to be examined and approved by the Commission pursuant to Article 14 of Regulation (EU) No 514/2014, Member States shall, within the objectives referred to in Article 3 of this Regulation, pursue in particular the strategic Union priorities listed in Annex I to this Regulation, taking account of the outcome of the policy dialogue referred to in Article 13 of Regulation (EU) No 514/2014. Member States shall not use more than 8 % of their total allocation under the national programme for the maintenance of Union IT systems and national IT systems contributing to the achievement of the objectives of this Regulation and not more than 8 % for actions in relation to or in third countries which implement the strategic Union priorities listed in Annex I to this Regulation. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 11 to amend, add or delete strategic Union priorities listed in Annex I to this Regulation. Article 8 Union actions 1. At the Commission\u2019s initiative, the Instrument may be used to finance transnational actions or actions of particular interest to the Union (\u2018Union actions\u2019) concerning the general, specific and operational objectives referred to in Article 3. 2. To be eligible for funding, Union actions shall be consistent with the priorities and initiatives identified at Union level, in particular those that have been endorsed by the European Parliament and the Council, in relevant Union strategies, policy cycles, programmes, threat and risk assessments, and support in particular: (a) preparatory, monitoring, administrative and technical activities, and the development of an evaluation mechanism required to implement the policies on police cooperation, preventing and combating crime, and crisis management; (b) transnational projects involving two or more Member States or at least one Member State and one third-country; (c) analytical, monitoring and evaluation activities, including threat, risk and impact assessments, which are evidence based and consistent with priorities and initiatives identified at Union level, in particular those that have been endorsed by the European Parliament and the Council and projects monitoring the implementation of Union law and Union policy objectives in the Member States; (d) projects promoting networking, public-private partnerships, mutual confidence, understanding and learning, identification and dissemination of best practices and innovative approaches at Union level, training and exchange programmes; (e) projects supporting the development of methodological, notably statistical, tools and methods and common indicators; (f) the acquisition, maintenance and/or further upgrading of technical equipment, expertise, secure facilities, infrastructures, related buildings and systems, especially ICT systems and their components at the Union level, including for the purpose of European cooperation on cyber security and cybercrime, notably the European Cybercrime Centre; (g) projects enhancing awareness of Union policies and objectives among stakeholders and the general public, including corporate communication on the political priorities of the Union; (h) particularly innovative projects developing new methods and/or deploying new technologies with a potential for transferability to other Member States, especially projects aiming at testing and validating the outcome of Union funded security research projects; (i) studies and pilot projects. 3. Within the objectives referred to in Article 3, the Instrument shall also support actions in relation to and in third countries, and in particular the following: (a) actions improving police cooperation and coordination between law enforcement authorities and, where applicable, international organisations, including joint investigation teams and any other form of cross-border joint operation, access to and exchange of information and interoperable technologies; (b) networking, mutual confidence, understanding and learning, identification, exchange and dissemination of know-how, experience and best practice, information sharing, shared situation awareness and foresight, contingency planning and interoperability; (c) acquisition, maintenance, and/or further upgrading of technical equipment, including ICT systems and their components; (d) exchange, training and education of staff and experts of relevant authorities, including language training; (e) awareness raising, dissemination and communication activities; (f) threat, risk and impact assessments; (g) studies and pilot projects. 4. Union actions shall be implemented in accordance with Article 6 of Regulation (EU) No .514/2014. Article 9 Technical assistance 1. At the initiative of and/or on behalf of the Commission, the Instrument may contribute up to EUR 800 000 annually for technical assistance to the Fund, in accordance with Article 9 of Regulation (EU) No .514/2014. 2. At the initiative of a Member State, the Instrument may finance technical assistance activities, in accordance with Article 20 of Regulation (EU) No 514/2014. The amount set aside for technical assistance shall not exceed, for the period 2014-2020, 5 % of the total amount allocated to a Member State plus EUR 200 000. Article 10 Emergency assistance 1. The Instrument shall provide financial assistance to address urgent and specific needs in the event of an emergency situation, as defined in point (j) of Article 2. 2. Emergency assistance shall be implemented in accordance with Articles 6 and 7 of Regulation (EU) No 514/2014. CHAPTER III FINAL PROVISIONS Article 11 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 7(3) shall be conferred on the Commission for a period of seven years from 21 May 2014. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the seven-year period. The delegation of power shall be tacitly extended for a period of three years, unless the European Parliament or the Council opposes such extension not later than three months before the end of the seven-year period. 3. The delegation of power referred to in Article 7(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 7(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 12 Applicability of Regulation (EU) No 514/2014 The provisions of Regulation (EU) No 514/2014 shall apply to the Instrument. Article 13 Repeal Decision 2007/125/JHA is repealed with effect from 1 January 2014. Article 14 Transitional provisions 1. This Regulation shall not affect the continuation or modification, including the total or partial cancellation of the projects until their closure or the financial assistance approved by the Commission on the basis of Decision 2007/125/JHA, or any other legislation applying to that assistance on 31 December 2013. 2. When adopting decisions on co-financing under the Instrument, the Commission shall take account of measures adopted on the basis of Decision 2007/125/JHA before 20 May 2014 which have financial repercussions during the period covered by that co-financing. 3. Sums committed for co-financing approved by the Commission between 1 January 2011 and 31 December 2014 for which the documents required for closure of the operations have not been sent to the Commission by the deadline for submitting the final report shall be automatically decommitted by the Commission by 31 December 2017, giving rise to the repayment of amounts unduly paid. Amounts relating to operations which have been suspended due to legal proceedings or administrative appeals having suspensive effect shall be disregarded in calculating the amount to be automatically decommitted. 4. The Commission shall submit to the European Parliament and the Council, by 31 December 2015, an ex-post evaluation of Decision 2007/125/JHA concerning the period 2007-2013. Article 15 Review The European Parliament and the Council shall, on the basis of a proposal of the Commission, review this Regulation by 30 June 2020. Article 16 Entry into force and application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 16 April 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 299, 4.10.2012, p. 108. (2) OJ C 277, 13.9.2012, p. 23. (3) Position of the European Parliament of 13 March 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014. (4) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (5) Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (see page 143 of this Official Journal). (6) Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (see page 112 of this Official Journal). (7) OJ C 373, 20.12.2013, p. 1. (8) Council Decision 2007/125/JHA of 12 February 2007 establishing for the period 2007 to 2013, as part of the General Programme on Security and Safeguarding Liberties, the Specific Programme \u2018Prevention of and Fight against Crime\u2019 (OJ L 58, 24.2.2007, p. 7). (9) Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, p. 884). (10) Regulation (EU) No 1382/2013 of the European Parliament and of the Council of 17 December 2013 establishing a Justice Programme for the period 2014 to 2020 (OJ L 354, 28.12.2013, p. 73). (11) Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924). (12) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 \u2014 the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104). (13) Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme of the Union\u2019s action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC (OJ L 86, 21.3.2014, p. 1). (14) Regulation (EU) No 231/2014 of the European Parliament and of the Council of 11 March 2014 establishing an Instrument for Pre-accession Assistance (IPA II) (OJ L 77, 15.3.2014, p. 11). (15) Regulation (EU) No 232/2014 of the European Parliament and of the Council of 11 March 2014 establishing a European Neighbourhood Instrument (OJ L 77, 15.3.2014, p. 27). (16) Regulation (EU) No 233/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for development cooperation for the period 2014-2020 (OJ L 77, 15.3.2014, p. 44). (17) Regulation (EU) No 234/2014 of the European Parliament and of the Council of 11 March 2014 establishing a Partnership Instrument for cooperation with third countries (OJ L 77, 15.3.2014, p. 77). (18) Regulation (EU) No 235/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for democracy and human rights worldwide (OJ L 77, 15.3.2014, p. 85). (19) Regulation (EU) No 230/2014 of the European Parliament and of the Council of 11 March 2014 establishing an Instrument contributing to Stability and Peace (OJ L 77, 15.3.2014, p. 1). (20) Council Decision 2009/902/JHA of 30 November 2009 setting-up a European Crime Prevention Network (EUCPN) and repealing Decision 2001/427/JHA (OJ L 321, 8.12.2009, p. 44). (21) Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (OJ L 300, 11.11.2008, p. 42). (22) Council Framework Decision 2002/475/JHA of 13 June 2002 on combating terrorism (OJ L 164, 22.6.2002, p. 3). (23) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). ANNEX I List of strategic Union priorities referred to in Article 7(2) \u2014 Measures preventing all types of crime and fighting cross-border, serious and organised crime, in particular projects implementing relevant policy cycles, drug trafficking, trafficking in human beings, sexual exploitation of children and projects identifying and dismantling criminal networks, enhancing capacities to fight corruption, protecting the economy against criminal infiltration and reducing financial incentives by seizing, freezing and confiscating criminal assets. \u2014 Measures preventing and combating cybercrime and raising the levels of security for citizens and business in cyberspace, in particular projects building capacities in law enforcement and the judiciary, projects ensuring work with industry to empower and protect citizens, and projects improving capabilities for dealing with cyber attacks. \u2014 Measures preventing and combating terrorism and addressing radicalisation and recruitment, in particular projects empowering communities to develop local approaches and prevention policies, projects enabling competent authorities to cut off terrorists from access to funding and materials and follow their transactions, projects protecting the transport of passengers and cargo, and projects enhancing the security of explosives and chemical, biological, radiological and nuclear materials. \u2014 Measures designed to raise Member States\u2019 administrative and operational capability to protect critical infrastructure in all economic sectors including those covered by Council Directive 2008/114/EC (1), in particular projects promoting public-private partnerships in order to build trust and facilitate cooperation, coordination, contingency planning and the exchange and dissemination of information and best practices among public and private actors. \u2014 Measures increasing the Union\u2019s resilience to crisis and disaster, in particular projects promoting the development of a coherent Union policy on risk management linking threat and risk assessments to decision making, as well as projects supporting an effective and coordinated response to crisis linking up existing sector-specific capabilities, expertise centres and situation awareness centres, including those for health, civil protection and terrorism. \u2014 Measures seeking to achieve a closer partnership between the Union and third countries, in particular countries situated on its external borders, and the drawing up and implementation of operational programmes of action for achievement of the above strategic Union priorities. (1) Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection (OJ L 345, 23.12.2008, p. 75). ANNEX II List of common indicators for the measurement of the specific objectives (a) Preventing and combating cross-border, serious and organised crime including terrorism, and reinforcing coordination and cooperation between law enforcement authorities of Member States and with relevant third countries. (i) Number of joint investigation teams (JITs) and European Multidisciplinary Platform against Criminal Threats (EMPACT) operational projects supported by the Instrument, including the participating Member States and authorities. For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as: \u2014 leader (Member State), \u2014 partners (Member States), \u2014 participating authorities, \u2014 participating EU Agency (Eurojust, Europol), if applicable. (ii) Number of law enforcement officials trained on cross-border-related topics with the help of the Instrument, and the duration of their training (person days). For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as: \u2014 by type of crime (referred to in Article 83 TFEU): terrorism, trafficking in human beings and sexual exploitation of women and children; illicit drug trafficking; illicit arms trafficking; money laundering; corruption; counterfeiting of means of payment; computer crime; organised crime; or \u2014 by horizontal area of law enforcement: information exchange; operational cooperation; (iii) Number and financial value of projects in the area of crime prevention For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down by type of crime (referred to in Article 83 TFEU): terrorism, trafficking in human beings and sexual exploitation of women and children; illicit drug trafficking; illicit arms trafficking; money laundering; corruption; counterfeiting of means of payment; computer crime; organised crime; (iv) Number of projects supported by the Instrument, aiming to improve law enforcement information exchange which are related to Europol data systems, repositories or communication tools. For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down by type of crime (referred to in Article 83 TFEU): data loaders, extending access to SIENA, projects aiming to improving input to analysis work files etc. (b) Enhancing the capacity of Member States and the Union for managing effectively security-related risks and crises, and preparing for and protecting people and critical infrastructure against terrorist attacks and other security-related incidents. (i) Number and tools put in place and/or further upgraded with the help of the Instrument to facilitate the protection of critical infrastructure by Member States in all sectors of the economy; (ii) Number of projects relating to the assessment and management of risks in the field of internal security supported by the Instrument; (iii) Number of expert meetings, workshops, seminars, conferences, publications, websites and online consultations organised with the help of the Instrument. For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as: \u2014 relating to critical infrastructure protection; or \u2014 relating to risk and crisis management. ANNEX III Figures for national programmes ISF POLICE \u2014 Amounts of national programmes MS Population (individuals) Territor (km2) # passengers # tons of cargo GDP/capita (EUR) Allocations (2013) (2012) air (2012) sea (2011) Total air (2012) sea (2011) Total (2012) 30 % 10 % 15 % 10 % 35 % 2014-2020 Number allocation Number allocation Numbers allocation Numbers allocation Number clef allocation AT 8 488 511 3 845 782 83 879 1 321 372 8 196 234 0 8 196 234 3 169 093 219 775 0 219 775 4 651 36 400 16,66 3 822 008 12 162 906 BE 11 183 350 5 066 698 30 528 480 917 8 573 821 0 8 573 821 3 315 088 1 068 434 232 789 000 233 857 434 4 948 770 34 000 17,84 4 091 797 17 903 270 BG 7 282 041 3 299 182 110 900 1 747 038 1 705 825 0 1 705 825 659 561 18 536 25 185 000 25 203 536 533 344 5 400 112,33 25 763 168 32 002 293 CH CY 862 011 390 540 9 251 145 734 1 587 211 107 000 1 694 211 655 071 28 934 6 564 000 6 592 934 139 516 20 500 29,59 6 786 396 8 117 257 CZ 10 516 125 4 764 407 78 866 1 242 401 3 689 113 0 3 689 113 1 426 404 58 642 0 58 642 1 241 14 500 41,83 9 594 559 17 029 012 DE 82 020 688 37 160 068 357 137 5 626 095 66 232 970 1 146 000 67 378 970 26 052 237 4 448 191 296 037 000 300 485 191 6 358 712 32 299 18,78 4 307 288 79 504 401 DK EE 1 286 479 582 849 45 227 712 475 466 960 61 000 527 960 204 137 23 760 48 479 000 48 502 760 1 026 390 12 700 47,76 10 954 418 13 480 269 ES 46 006 414 20 843 540 505 991 7 971 031 24 450 017 3 591 000 28 041 017 10 842 125 592 192 398 332 000 398 924 192 8 441 827 22 700 26,72 6 128 683 54 227 207 FI 5 426 674 2 458 594 338 432 5 331 428 3 725 547 250 000 3 975 547 1 537 155 195 622 115 452 000 115 647 622 2 447 275 35 600 17,04 3 907 896 15 682 348 FR 65 633 194 29 735 595 632 834 9 969 228 48 440 037 906 000 49 346 037 19 079 761 1 767 360 322 251 000 324 018 360 6 856 709 31 100 19,50 4 473 348 70 114 640 GR 11 290 067 5 115 047 131 957 2 078 760 5 992 242 66 000 6 058 242 2 342 434 72 187 135 314 000 135 386 187 2 864 972 17 200 35,27 8 088 437 20 489 650 HR 4 398 150 1 992 614 87 661 1 380 951 4 526 664 5 000 4 531 664 1 752 179 6 915 21 862 000 21 868 915 462 779 10 300 58,89 13 506 904 19 095 426 HU 9 906 000 4 487 985 93 024 1 465 432 1 327 200 0 1 327 200 513 165 61 855 0 61 855 1 309 9 800 61,90 14 196 032 20 663 922 IE 4 582 769 2 076 257 69 797 1 099 534 3 139 829 0 3 139 829 1 214 022 113 409 45 078 000 45 191 409 956 317 35 700 16,99 3 896 950 9 243 080 IS IT 59 394 207 26 908 977 301 336 4 747 041 21 435 519 1 754 000 23 189 519 8 966 282 844 974 499 885 000 500 729 974 10 596 188 25 700 23,60 5 413 273 56 631 761 LI LT 2 971 905 1 346 443 65 300 1 028 692 504 461 0 504 461 195 051 15 425 42 661 000 42 676 425 903 096 11 000 55,15 12 647 374 16 120 656 LU 537 039 243 309 2 586 40 738 365 944 0 365 944 141 493 615 287 0 615 287 13 020 83 600 7,26 1 664 128 2 102 689 LV 2 017 526 914 055 64 562 1 017 066 1 465 671 676 000 2 141 671 828 082 31 460 67 016 000 67 047 460 1 418 824 10 900 55,65 12 763 405 16 941 431 MT 421 230 190 841 316 4 978 335 863 0 335 863 129 862 16 513 5 578 000 5 594 513 118 388 16 300 37,21 8 535 037 8 979 107 NL 16 779 575 7 602 108 41 540 654 399 23 172 904 0 23 172 904 8 959 858 1 563 499 491 695 000 493 258 499 10 438 081 35 800 16,94 3 886 065 31 540 510 NO PL 38 533 299 17 457 791 312 679 4 925 731 4 219 070 9 000 4 228 070 1 634 793 68 306 57 738 000 57 806 306 1 223 267 9 900 61,27 14 052 637 39 294 220 PT 10 487 289 4 751 342 92 212 1 452 643 5 534 972 0 5 534 972 2 140 110 116 259 67 507 000 67 623 259 1 431 008 15 600 38,88 8 918 020 18 693 124 RO 21 305 097 9 652 429 238 391 3 755 444 1 239 298 0 1 239 298 479 177 28 523 38 918 000 38 946 523 824 166 6 200 97,84 22 438 889 37 150 105 SE 9 555 893 4 329 367 438 576 6 909 023 5 757 921 1 320 000 7 077 921 2 736 695 144 369 181 636 000 181 780 369 3 846 742 43 000 14,11 3 235 375 21 057 201 SI 2 058 821 932 764 20 273 319 367 513 394 0 513 394 198 505 9 015 16 198 000 16 207 015 342 964 17 200 35,27 8 088 437 9 882 037 SK 5 410 836 2 451 419 49 036 772 480 330 166 0 330 166 127 659 20 894 0 20 894 442 13 200 45,95 10 539 478 13 891 478 UK Total 438 355 190 198 600 000 4 202 290 66 200 000 246 928 853 9 891 000 256 819 853 99 300 000 12 150 336 3 116 175 000 3 128 325 336 66 200 000 606 599 1 010 231 700 000 662 000 000 Budget allocation share 198 600 000 66 200 000 99 300 000 66 200 000 231 700 000 662 000 000", "summary": "A safer EU: police cooperation, and crisis management A safer EU: police cooperation, and crisis management Regulation (EU) No 513/2014 sets out the rules for a European Union financing instrument which, as part of the Internal Security Fund (ISF), concerns police cooperation, preventing and combating crime, and crisis management. ACT Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA. SUMMARY Known as the ISF-Police regulation, the instrument aims to contribute to a high level of security in the EU. To reach this objective, it will support actions related to crime prevention; combating cross-border, serious and organised crime, including terrorism; and strengthening cooperation between law enforcement authorities and other authorities in EU countries, with Europol and other EU bodies, and with relevant non-EU countries and international organisations. It will also support actions to enhance the capacity of EU countries and the EU for managing security-related risks and crises effectively, and preparing for and protecting people and critical infrastructure (e.g. electricity, water, transport) against terrorist attacks and other security-related incidents. Operational objectives 1. Strengthen EU countries\u2019 capability to prevent and combat cross-border crime. 2. Promote cooperation among EU countries\u2019 law enforcement authorities (police, customs, etc.) and between EU countries and Europol. 3. Develop training schemes, including technical and professional skills and knowledge of obligations relating to respect of human rights. 4. Develop measures, safeguards, mechanisms and best practices for early identification, protection and support of witnesses and victims of crime. 5. Develop measures to strengthen EU countries\u2019 administrative and operational capability to protect critical infrastructure. 6. Enable the rapid production of comprehensive and accurate overviews in crisis situations, coordinate response measures and share secret or sensitive information. 7. Develop integrated approaches based on common and shared appreciations in crisis situations and enhance mutual understanding of EU countries\u2019 and partner countries\u2019 various definitions of threat levels. Examples of eligible actions include: \u2014 actions to improve police cooperation, including joint investigation teams; \u2014 communication activities; \u2014 maintenance of EU and national IT systems, notably on cybersecurity and cybercrime; \u2014 projects in relation to and in non-EU-countries. National programmes will be drawn up by participating countries to address the fund\u2019s objectives and submitted to the European Commission for approval. Any allocation of resources among objectives must be proportional to the challenges and needs faced by the country. Budget The programme\u2019s 2014-20 budget is set at \u20ac1.004 billion, broken down as follows (in current prices): \u2014 \u20ac662 million for EU countries\u2019 programmes (the regulation details how this is to be allocated among them); \u2014 \u20ac342 million for EU actions, emergency assistance and technical assistance at the initiative of the European Commission. Implementation Regulation (EU) No 514/2014 contains the main rules and procedures for implementing this fund. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 513/2014 21.5.2014 - OJ L 150 of 20.5.2014 RELATED ACTS Regulation No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management [Official Journal L 150 of 20 May 2014]. Last updated: 10.08.2014"}
{"article": "14.11.2012 EN Official Journal of the European Union L 316/34 REGULATION (EU) No 1026/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 on certain measures for the purpose of the conservation of fish stocks in relation to countries allowing non-sustainable fishing THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) and Article 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) As provided in the United Nations Convention on the Law of the Sea of 10 December 1982 (\u2018UNCLOS\u2019) and in the United Nations Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks of 4 August 1995 (\u2018UNFSA\u2019), the management of certain shared, straddling and highly migratory fish stocks requires the cooperation of all the countries in whose waters the stock occurs (the coastal States) and the countries whose fleets exploit that stock (the fishing States). This cooperation may be established in the framework of regional fisheries management organisations (\u2018RFMOs\u2019) or, where RFMOs have no competence for the stock in question, by means of ad hoc arrangements among the countries having an interest in the fishery. (2) Where a third country with an interest in a fishery involving a stock of common interest to that country and to the Union allows, without due regard to existing fishing patterns or the rights, duties and interests of other countries and the Union, fisheries activities that jeopardise the sustainability of that stock, and fails to cooperate with other countries and the Union in its management, specific measures should be adopted in order to encourage that country to contribute to the conservation of that stock. (3) Fish stocks should be considered to be in an unsustainable state when they are not continuously maintained at or above the levels that can produce maximum sustainable yield or, if these levels cannot be estimated, when the stocks are not continuously maintained within safe biological limits. (4) It is necessary to define the conditions upon which a country can be considered to be a country allowing non-sustainable fishing and subject to measures under this Regulation, including a process granting the countries concerned the right to be heard and allowing them an opportunity to adopt corrective action. (5) In addition, it is necessary to define the type of measures that may be taken with regard to countries allowing non-sustainable fishing and to establish general conditions for the adoption of such measures, so that they are based on objective criteria and are equitable, cost-effective and compatible with international law, in particular with the Agreement establishing the World Trade Organisation. (6) Such measures should aim to remove the incentives for countries allowing non-sustainable fishing to fish the stock of common interest. This can be achieved inter alia by restricting the importation of fish products caught by vessels conducting fisheries on a stock of common interest under the control of the country allowing non-sustainable fishing, by restricting the access to ports for those vessels, or by preventing Union fishing vessels or Union fishing equipment from being used for fishing the stock of common interest under the control of the country allowing non-sustainable fishing. (7) In order to ensure that Union action for the conservation of fish stocks is effective and coherent, it is important that the measures set out in Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (3) are taken into consideration. (8) In order to guarantee that measures adopted against a country under this Regulation are environmentally sound, effective, proportionate and compatible with international rules, it is necessary for their adoption to be preceded by an evaluation of their expected environmental, trade, economic and social effects. (9) If measures adopted against a country under this Regulation are ineffective and that country continues to be considered to be a country allowing non-sustainable fishing, further measures may be adopted in accordance with this Regulation. (10) The measures adopted against a country under this Regulation should cease to apply when the country allowing non-sustainable fishing has adopted the measures necessary for its contribution to the conservation of the stock of common interest. (11) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission with regard to identifying a country allowing non-sustainable fishing, to adopting measures in respect of such country and to deciding that such measures should cease to apply. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (4). (12) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the end of application of measures taken pursuant to this Regulation, imperative grounds of urgency so require, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. This Regulation lays down a framework for the adoption of certain measures regarding the fisheries-related activities and policies of third countries in order to ensure the long-term conservation of stocks of common interest to the Union and those third countries. 2. The measures adopted pursuant to this Regulation may apply in all cases where cooperation between third countries and the Union is required for the joint management of the stocks of common interest, including where that cooperation takes place in the context of an RFMO or a similar body. Article 2 Definitions For the purposes of this Regulation the following definitions shall apply: (a) \u2018stock of common interest\u2019 means a fish stock the geographical distribution of which makes it available to both the Union and third countries and the management of which requires the cooperation between such countries and the Union, in either bilateral or multilateral settings; (b) \u2018associated species\u2019 means any fish that belongs to the same ecosystem as the stock of common interest and that preys upon that stock, is preyed on by it, competes with it for food and living space or co-occurs with it in the same fishing area, and that is exploited or accidentally taken in the same fishery or fisheries; (c) \u2018regional fisheries management organisation\u2019 or \u2018RFMO\u2019 means a sub-regional, regional or a similar organisation with competence under international law to establish conservation and management measures for living marine resources placed under its responsibility by virtue of the convention or agreement by which it was established; (d) \u2018importation\u2019 means the introduction of fish or fishery products into the territory of the Union, including for transhipment purposes at ports in its territory; (e) \u2018transhipment\u2019 means the unloading of all or any fish or fishery products on board a fishing vessel to another fishing vessel; (f) \u2018unsustainable state\u2019 means the condition where the stock is not continuously maintained at or above the levels that can produce maximum sustainable yield or, if these levels cannot be estimated, where the stock is not continuously maintained within safe biological limits; the stock levels determining whether the stock is in an unsustainable state are to be determined on the basis of best available scientific advice; (g) \u2018safe biological limits\u2019 means the boundaries of the size of a stock within which the stock can replenish itself with high probability while allowing high yield fisheries on it; (h) \u2018country\u2019 means a third country, including territories enjoying self-governing status and endowed with competencies in the area of conservation and management of living marine resources. Article 3 Countries allowing non-sustainable fishing A country may be identified as a country allowing non-sustainable fishing where: (a) it fails to cooperate in the management of a stock of common interest in full compliance with the provisions of the UNCLOS and the UNFSA, or any other international agreement or norm of international law; and (b) either: (i) it fails to adopt necessary fishery management measures; or (ii) it adopts fishery management measures without due regard to the rights, interests and duties of other countries and the Union, and those fishery management measures, when considered in conjunction with measures taken by other countries and the Union, lead to fishing activities which could result in the stock being in an unsustainable state. This condition is considered to be complied with also where the fishery management measures adopted by that country did not lead to the stock being in an unsustainable state solely due to measures adopted by others. Article 4 Measures in respect of countries allowing non-sustainable fishing 1. The Commission may adopt, by means of implementing acts, the following measures in respect of a country allowing non-sustainable fishing: (a) identifying that country as a country allowing non-sustainable fishing; (b) identifying, where necessary, the specific vessels or fleets of that country to which certain measures are to apply; (c) imposing quantitative restrictions on importations of fish from the stock of common interest that have been caught under the control of that country and on importations of fishery products made of or containing such fish; (d) imposing quantitative restrictions on importations of fish of any associated species, and fishery products made of or containing such fish, when caught while conducting fisheries on the stock of common interest under the control of that country; when adopting the measure, the Commission shall, in accordance with Article 5(4) of this Regulation, in application of the principle of proportionality, determine which species and their catches fall within the scope of the measure; (e) imposing restrictions on the use of Union ports by vessels flying the flag of that country that fish the stock of common interest and/or associated species and by vessels transporting fish and fishery products stemming from the stock of common interest and/or associated species that have been caught either by vessels flying the flag of that country or by vessels authorised by it while flying another flag; such restrictions shall not apply in cases of force majeure or distress within the meaning of Article 18 of the UNCLOS for services strictly necessary to remedy those situations; (f) prohibiting the purchase by Union economic operators of a fishing vessel flying the flag of that country; (g) prohibiting the reflagging of fishing vessels flying the flag of a Member State to the flag of that country; (h) prohibiting Member States from authorising the conclusion of chartering agreements whereby Union economic operators charter their vessels to economic operators of that country; (i) prohibiting the exportation to that country of fishing vessels flying the flag of a Member State or of fishing equipment and supplies needed to fish on the stock of common interest; (j) prohibiting the conclusion of private trade arrangements between Union economic operators and that country that enable a fishing vessel flying the flag of a Member State to use fishing opportunities of that country; (k) prohibiting joint fishing operations involving fishing vessels flying the flag of a Member State and fishing vessels flying the flag of that country. 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 8(2). Article 5 General requirements concerning the measures adopted pursuant to this Regulation 1. The measures referred to in Article 4 shall be: (a) related to the conservation of the stock of common interest; (b) made effective in conjunction with restrictions on fishing by Union vessels, or on production or consumption within the Union, applicable to fish and fishery products made of or containing such fish of the species for which the measures have been adopted; (c) proportionate to the objectives pursued and compatible with the obligations imposed by international agreements to which the Union is a party and any other relevant norms of international law. 2. The measures referred to in Article 4 shall take into account measures already taken pursuant to Regulation (EC) No 1005/2008. 3. The measures referred to in Article 4 shall not be applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail or a disguised restriction on international trade. 4. When adopting the measures referred to in Article 4, the Commission shall, in order to ensure that those measures are environmentally sound, effective, proportionate and compatible with international rules, evaluate the environmental, trade, economic and social effects of those measures in the short and long terms and the administrative burden associated with their implementation. 5. The measures referred to in Article 4 shall provide for an appropriate system for their enforcement by competent authorities. Article 6 Procedures prior to the adoption of measures in respect to countries allowing non-sustainable fishing 1. Where the Commission considers that it is necessary to adopt measures referred to in Article 4, it shall notify the country concerned of the intention to identify it as a country allowing non-sustainable fishing. In such cases, the European Parliament and the Council shall be immediately informed. 2. That notification shall include information on the reasons for the identification of that country as a country allowing non-sustainable fishing and shall describe the possible measures that may be taken in relation to it pursuant to this Regulation. 3. Prior to adopting measures referred to in Article 4, the Commission shall provide the country concerned with a reasonable opportunity to respond to the notification in writing and to remedy the situation within one month of receiving that notification. Article 7 Period of application of the measures in respect to countries allowing non-sustainable fishing 1. The measures referred to in Article 4 shall cease to apply when the country allowing non-sustainable fishing adopts appropriate corrective measures necessary for the conservation and management of the stock of common interest and those corrective measures: (a) have either been adopted autonomously or have been agreed in the context of consultations with the Union and, where applicable, other countries concerned; and (b) do not undermine the effect of measures taken by the Union either autonomously, or in cooperation with other countries, for the purpose of the conservation of the fish stocks concerned. 2. The Commission shall adopt implementing acts determining whether the conditions laid down in paragraph 1 have been complied with and, where necessary, providing that the measures adopted in respect of the country concerned pursuant to Article 4 cease to apply. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 8(2). On duly justified imperative grounds of urgency relating to unforeseen economic or social disruption, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 8(3) to decide that the measures adopted pursuant to Article 4 are to cease to apply. Article 8 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. 4. The results of the evaluation referred to in Article 5(4), shall be made available to the European Parliament and the Council, in accordance with the procedure provided for in Article 10(4) of Regulation (EU) No 182/2011, together with the documents referred to therein. Article 9 Entry into force This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 October 2012. For the European Parliament The President M. SCHULZ For the Council The President A. D. MAVROYIANNIS (1) OJ C 229, 31.7.2012, p. 112. (2) Position of the European Parliament of 12 September 2012 (not yet published in the Official Journal) and decision of the Council of 25 September 2012. (3) OJ L 286, 29.10.2008, p. 1. (4) OJ L 55, 28.2.2011, p. 13.", "summary": "Conserving fish stocks in countries with unsustainable fishing Conserving fish stocks in countries with unsustainable fishing SUMMARY OF: Regulation (EU) No 1026/2012 \u2014 measures for the purpose of the conservation of fish stocks in relation to countries allowing non-sustainable fishing WHAT IS THE AIM OF THIS REGULATION? It sets up a system allowing the EU to adopt measures in regard to the activities and policies of certain non-EU countries which allow non-sustainable fishing. These measures are designed to help the conservation of fish stocks of common interest* both to the EU and the non-EU countries in question. KEY POINTS A country is identified as a country allowing non-sustainable fishing where: it fails to cooperate in the management of a stock of common interest in full compliance with the rules agreed in the 1982 United Nations Convention on the Law of the Sea and in the 1995 United Nations Fish Stocks Agreement, or any other international agreement or norm of international law; and either: it fails to adopt necessary fishery management measures; orit adopts fishery management measures without due regard to the rights, interests and duties of other countries and the EU which, when cumulated with the measures taken by other countries and the EU, lead to fishing which could result in unsustainable stocks. Measures the EU can take Examples of the measures that the European Commission can take in respect of a country allowing non-sustainable fishing include: quotas on imports of fish from the stock of common interest that have been caught under the control of that country and on imports of fishery products containing such fish; restrictions on the use of EU ports by vessels flying the flag of that country which fish or which transport fish or fish products derived from the stock of common interest and/or associated species,flying another flag that are authorised by that country; bans on the purchase by EU fishing companies of a fishing vessel flying the flag of that country; bans on the reflagging of fishing vessels flying the flag of an EU country to the flag of that country; bans on the export to that country of fishing vessels flying the flag of an EU country or of fishing equipment and supplies needed to fish on the stock of common interest; bans on making private trade arrangements between EU fishing operators and that country that enable a fishing vessel flying the flag of an EU country to use fishing opportunities of that country; prohibiting joint fishing operations involving EU fishing vessels and fishing vessels flying the flag of that country. All measures taken must be: related to the conservation of the stock of common interest; made effective in conjunction with restrictions on fishing by EU vessels, or on production or consumption within the EU, of fish and products containing fish of the species for which the measures have been adopted; proportionate to the objectives pursued and compatible with the obligations imposed by international agreements to which the EU is a party and any other relevant norms of international law. Prior to adopting measures, the Commission must notify the country concerned of the intention to identify it as a country allowing non-sustainable fishing. In such cases, it must immediately inform the European Parliament and the Council. FROM WHEN DOES THE REGULATION APPLY? It has applied since 17 November 2012. KEY TERMS Stock of common interest: a fish stock whose geographical distribution makes it available to both EU and non-EU countries and the management of which requires the cooperation between such countries and the EU, in either bilateral or multilateral settings. MAIN DOCUMENT Regulation (EU) No 1026/2012 of the European Parliament and of the Council of 25 October 2012 on certain measures for the purpose of the conservation of fish stocks in relation to countries allowing non-sustainable fishing (OJ L 316, 14.11.2012, pp. 34-37) last update 05.12.2017"}
{"article": "20.12.2012 EN Official Journal of the European Union L 351/40 REGULATION (EU) No 1219/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2012 establishing transitional arrangements for bilateral investment agreements between Member States and third countries THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Following the entry into force of the Treaty of Lisbon, foreign direct investment is included in the list of matters falling under the common commercial policy. In accordance with Article 3(1)(e) of the Treaty on the Functioning of the European Union (\u2018TFEU\u2019), the European Union has exclusive competence with respect to the common commercial policy. Accordingly, only the Union may legislate and adopt legally binding acts within that area. The Member States are able to do so themselves only if so empowered by the Union, in accordance with Article 2(1) TFEU. (2) In addition, Chapter 4 of Title IV of Part Three TFEU lays down common rules on the movement of capital between Member States and third countries, including in respect of capital movements involving investments. Those rules can be affected by international agreements relating to foreign investment concluded by Member States. (3) This Regulation is without prejudice to the allocation of competences between the Union and its Member States in accordance with the TFEU. (4) At the time of the entry into force of the Treaty of Lisbon, Member States maintained a significant number of bilateral investment agreements with third countries. The TFEU does not contain any explicit transitional provisions for such agreements which have now come under the Union\u2019s exclusive competence. Furthermore, some of those agreements may include provisions affecting the common rules on capital movements laid down in Chapter 4 of Title IV of Part Three TFEU. (5) Although bilateral investment agreements remain binding on the Member States under public international law and will be progressively replaced by agreements of the Union relating to the same subject matter, the conditions for their continuing existence and their relationship with the Union\u2019s investment policy require appropriate management. That relationship will develop further as the Union exercises its competence. (6) In the interest of Union investors and their investments in third countries, and of Member States hosting foreign investors and investments, bilateral investment agreements that specify and guarantee the conditions of investment should be maintained in force and progressively replaced by investment agreements of the Union, providing for high standards of investment protection. (7) This Regulation should address the status under Union law of bilateral investment agreements of the Member States signed before 1 December 2009. Those agreements can be maintained in force, or enter into force, in accordance with this Regulation. (8) This Regulation should also lay down the conditions under which Member States are empowered to conclude and/or maintain in force bilateral investment agreements signed between 1 December 2009 and 9 January 2013. (9) Moreover, this Regulation should lay down the conditions under which Member States are empowered to amend or conclude bilateral investment agreements with third countries after 9 January 2013. (10) Where bilateral investment agreements with third countries are maintained in force by Member States under this Regulation, or authorisations have been granted to open negotiations or conclude such agreements, that should not prevent the negotiation or conclusion of investment agreements by the Union. (11) Member States are required to take the necessary measures to eliminate incompatibilities, where they exist, with Union law, contained in bilateral investment agreements concluded between them and third countries. The implementation of this Regulation is without prejudice to the application of Article 258 TFEU with respect to failures of Member States to fulfil obligations under Union law. (12) The authorisation to amend or conclude bilateral investment agreements provided for by this Regulation should notably allow Member States to address any incompatibilities between their bilateral investment agreements and Union law, other than incompatibilities arising from the allocation of competences between the Union and its Member States, which are addressed in this Regulation. (13) The Commission should present to the European Parliament and the Council a report on the application of this Regulation. That report should, inter alia, review the need for the continued application of Chapter III. Where the report recommends discontinuing the application of the provisions of Chapter III or where it proposes modifying those provisions, it may be accompanied, if appropriate, by a legislative proposal. (14) The European Parliament, the Council and the Commission should ensure that any information identified as confidential is treated in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (2). (15) Investment agreements between Member States should not be covered by this Regulation. (16) It is necessary to provide for certain arrangements to ensure that bilateral investment agreements, maintained in force pursuant to this Regulation, remain operational, including as regards dispute settlement, while at the same time respecting the Union\u2019s exclusive competence. (17) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (3). (18) Specifically, those powers should be conferred on the Commission given that the procedures set out in Articles 9, 11 and 12 empower Member States to act in areas of the Union\u2019s exclusive competence and decisions thereon must be taken at Union level. (19) The advisory procedure should be used for the adoption of authorisations pursuant to Articles 9, 11 and 12, given that those authorisations are to be granted on the basis of clearly defined criteria established in this Regulation, HAVE ADOPTED THIS REGULATION: CHAPTER I SCOPE Article 1 Subject matter and scope 1. Without prejudice to the division of competences established by the TFEU, this Regulation addresses the status of the bilateral investment agreements of the Member States under Union law, and establishes the terms, conditions and procedures under which the Member States are authorised to amend or conclude bilateral investment agreements. 2. For the purpose of this Regulation the term \u2018bilateral investment agreement\u2019 means any agreement with a third country that contains provisions on investment protection. This Regulation covers only those provisions of bilateral investment agreements dealing with investment protection. CHAPTER II MAINTENANCE IN FORCE OF EXISTING BILATERAL INVESTMENT AGREEMENTS Article 2 Notification to the Commission By 8 February 2013 or within 30 days of the date of their accession to the Union, the Member States shall notify the Commission of all bilateral investment agreements with third countries signed before 1 December 2009 or before the date of their accession, whichever is later, that they either wish to maintain in force or permit to enter into force under this Chapter. The notification shall include a copy of those bilateral investment agreements. Member States shall also notify the Commission of any subsequent changes to the status of those agreements. Article 3 Maintenance in force Without prejudice to other obligations of the Member States under Union law, bilateral investment agreements notified pursuant to Article 2 of this Regulation may be maintained in force, or enter into force, in accordance with the TFEU and this Regulation, until a bilateral investment agreement between the Union and the same third country enters into force. Article 4 Publication 1. Every 12 months the Commission shall publish in the Official Journal of the European Union a list of the bilateral investment agreements notified pursuant to Article 2, Article 11(6) or Article 12(6). 2. The first publication of the list of bilateral investment agreements referred to in paragraph 1 of this Article shall take place no later than three months after the deadline for notifications made pursuant to Article 2. Article 5 Assessment The Commission may assess the bilateral investment agreements notified pursuant to Article 2, by evaluating whether one or more of their provisions constitute a serious obstacle to the negotiation or conclusion by the Union of bilateral investment agreements with third countries, with a view to the progressive replacement of the bilateral investment agreements notified pursuant to Article 2. Article 6 Duty of cooperation 1. The Member States shall take any appropriate measures to ensure that the provisions of the bilateral investment agreements notified pursuant to Article 2 do not constitute a serious obstacle to the negotiation or conclusion by the Union of bilateral investment agreements with third countries, with a view to the progressive replacement of the bilateral investment agreements notified pursuant to Article 2. 2. If the Commission establishes that one or more of the provisions of a bilateral investment agreement notified pursuant to Article 2 constitute a serious obstacle to the negotiation or conclusion by the Union of bilateral investment agreements with third countries, with a view to the progressive replacement of the bilateral investment agreements notified pursuant to Article 2, the Commission and the Member State concerned shall enter into consultations expeditiously and cooperate with a view to identifying the appropriate actions to resolve the matter. Those consultations shall take no longer than 90 days. 3. Without prejudice to paragraph 1, the Commission may, within 60 days of the end of consultations, indicate the appropriate measures to be taken by the Member State concerned in order to remove the obstacles referred to in paragraph 2. CHAPTER III AUTHORISATION TO AMEND OR CONCLUDE BILATERAL INVESTMENT AGREEMENTS Article 7 Authorisation to amend or conclude a bilateral investment agreement Subject to the conditions laid down in Articles 8 to 11, a Member State shall be authorised to enter into negotiations with a third country to amend an existing or to conclude a new bilateral investment agreement. Article 8 Notification to the Commission 1. Where a Member State intends to enter into negotiations with a third country in order to amend or conclude a bilateral investment agreement, it shall notify the Commission of its intentions in writing. 2. The notification referred to in paragraph 1 shall include relevant documentation and an indication of the provisions to be addressed in the negotiations or to be renegotiated, the objectives of the negotiations and any other relevant information. 3. The notification referred to in paragraph 1 shall be transmitted at least five months before formal negotiations are to commence. 4. Where the information transmitted by the Member State is not sufficient for the purposes of authorising the opening of formal negotiations in accordance with Article 9, the Commission may request additional information. 5. The Commission shall make the notification referred to in paragraph 1 of this Article and, on request, the accompanying documentation, available to the other Member States subject to the requirements of confidentiality laid down in Article 14. Article 9 Authorisation to open formal negotiations 1. The Commission shall authorise the Member States to open formal negotiations with a third country to amend or conclude a bilateral investment agreement unless it concludes that the opening of such negotiations would: (a) be in conflict with Union law other than the incompatibilities arising from the allocation of competences between the Union and its Member States; (b) be superfluous, because the Commission has submitted or has decided to submit a recommendation to open negotiations with the third country concerned pursuant to Article 218(3) TFEU; (c) be inconsistent with the Union\u2019s principles and objectives for external action as elaborated in accordance with the general provisions laid down in Chapter 1 of Title V of the Treaty on European Union; or (d) constitute a serious obstacle to the negotiation or conclusion of bilateral investment agreements with third countries by the Union. 2. As part of the authorisation referred to in paragraph 1, the Commission may require the Member State to include or remove from such negotiations and prospective bilateral investment agreement any clauses where necessary to ensure consistency with the Union\u2019s investment policy or compatibility with Union law. 3. The authorisation referred to in paragraph 1 of this Article shall be granted in accordance with the advisory procedure referred to in Article 16(2). The Commission shall take its decision within 90 days of receipt of the notification referred to in Article 8. Where additional information is needed to take a decision, the 90-day period shall run from the date of receipt of the additional information. 4. The Commission shall inform the European Parliament and the Council about the decisions taken pursuant to paragraph 3. 5. In the event that the Commission does not grant an authorisation pursuant to paragraph 1, it shall inform the Member State concerned thereof and state the reasons therefor. Article 10 Participation of the Commission in negotiations The Commission shall be kept informed of the progress and results of the negotiations to amend or to conclude a bilateral investment agreement throughout the different stages and may request to participate in the negotiations concerning investment between the Member State and the third country. Article 11 Authorisation to sign and conclude a bilateral investment agreement 1. Before signing a bilateral investment agreement, the Member State concerned shall notify the Commission of the outcome of negotiations and shall transmit the text of such an agreement to the Commission. 2. This Article shall also apply to bilateral investment agreements which were negotiated before 9 January 2013, but are not subject to the obligation to notify under Article 2 or under Article 12. 3. Upon notification the Commission shall make an assessment as to whether the negotiated bilateral investment agreement conflicts with the requirements of Article 9(1) and (2). 4. Where the Commission finds that the negotiations have resulted in a bilateral investment agreement which fulfils the requirements of Article 9(1) and (2), it shall authorise the Member State to sign and conclude such an agreement. Articles 3, 5 and 6 apply to such agreements, as if they had been notified under Article 2. 5. Decisions pursuant to paragraph 4 of this Article shall be taken in accordance with the advisory procedure referred to in Article 16(2). The Commission shall take its decision within 90 days of receipt of the notifications referred to in paragraphs 1 and 2 of this Article. Where additional information is needed to take the decision, the 90-day period shall run from the date of receipt of the additional information. 6. Where the Commission grants an authorisation pursuant to paragraph 4, the Member State concerned shall notify the Commission of the conclusion and entry into force of the bilateral investment agreement, and of any subsequent changes to the status of that agreement. 7. The Commission shall inform the European Parliament and the Council about the decisions taken pursuant to paragraph 4. 8. In the event that the Commission does not grant the authorisation pursuant to paragraph 4, it shall inform the Member State concerned thereof and state the reasons therefor. CHAPTER IV FINAL PROVISIONS Article 12 Agreements signed by the Member States between 1 December 2009 and 9 January 2013 1. Where between 1 December 2009 and 9 January 2013, a Member State has signed a bilateral investment agreement, that Member State shall notify the Commission of such an agreement which it wishes to maintain in force or permit to enter into force by 8 February 2013. The notification shall include a copy of such an agreement. 2. Upon notification the Commission shall make an assessment as to whether the bilateral investment agreement notified pursuant to paragraph 1 of this Article conflicts with the requirements of Article 9(1) and (2). 3. Where the Commission finds that a bilateral investment agreement notified pursuant to paragraph 1 of this Article fulfils the requirements of Article 9(1) and (2), it shall authorise the maintenance or entry into force of such an agreement under Union law. 4. The Commission shall take the decision referred to in paragraph 3 of this Article within 180 days of receipt of the notification referred to in paragraph 1 of this Article. Where additional information is needed to take the decision, the 180-day period shall run from the date of receipt of the additional information. Decisions pursuant to paragraph 3 of this Article shall be taken in accordance with the advisory procedure referred to in Article 16(2). 5. Unless a bilateral investment agreement has been authorised under paragraph 3, the Member State shall not take any further steps towards the conclusion of such an agreement, and shall withdraw or reverse those steps which have been taken. 6. Where the Commission grants an authorisation pursuant to paragraph 3 of this Article, the Member State concerned shall notify the Commission of the entry into force of the bilateral investment agreement and of any subsequent changes to the status of such an agreement. Articles 3, 5 and 6 shall apply to such an agreement as if it had been notified under Article 2. 7. The Commission shall inform the European Parliament and the Council about the decisions taken pursuant to paragraph 3. 8. In the event that the Commission does not grant an authorisation pursuant to paragraph 3, it shall inform the Member State concerned thereof and state the reasons therefor. Article 13 Conduct of Member States with regard to a bilateral investment agreement with a third country Where a bilateral investment agreement falls within the scope of this Regulation, the Member State concerned shall: (a) inform the Commission without undue delay of all meetings which will take place under the provisions of the agreement. The Commission shall be provided with the agenda and all relevant information permitting an understanding of the topics to be discussed at those meetings. The Commission may request further information from the Member State concerned. Where an issue to be discussed might affect the implementation of the Union\u2019s policies relating to investment, including in particular the common commercial policy, the Commission may require the Member State concerned to take a particular position; (b) inform the Commission without undue delay of any representations made to it that a particular measure is inconsistent with the agreement. The Member State shall also immediately inform the Commission of any request for dispute settlement lodged under the auspices of the bilateral investment agreement as soon as the Member State becomes aware of such a request. The Member State and the Commission shall fully cooperate and take all necessary measures to ensure an effective defence which may include, where appropriate, the participation in the procedure by the Commission; (c) seek the agreement of the Commission before activating any relevant mechanisms for dispute settlement against a third country included in the bilateral investment agreement and shall, where requested by the Commission, activate such mechanisms. Those mechanisms shall include consultations with the other party to a bilateral investment agreement and dispute settlement where provided for in the agreement. The Member State and the Commission shall fully cooperate in the conduct of procedures within the relevant mechanisms, which may include, where appropriate, the participation in the relevant procedures by the Commission. Article 14 Confidentiality In notifying the Commission of negotiations and their outcome in accordance with Articles 8 and 11, Member States may indicate whether any of the information provided is to be considered confidential and whether it may be shared with the other Member States. Article 15 Review 1. The Commission shall present to the European Parliament and the Council a report on the application of this Regulation by 10 January 2020. 2. The report shall include an overview of authorisations requested and granted under Chapter III as well as a review of the need for the continued application of that Chapter. 3. Where the report recommends discontinuing the application of Chapter III or modifying its provisions, that report shall be accompanied by an appropriate legislative proposal. Article 16 Committee procedure 1. The Commission shall be assisted by the Committee for Investment Agreements. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 17 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 12 December 2012. For the European Parliament The President M. SCHULZ For the Council The President A. D. MAVROYIANNIS (1) Position of the European Parliament of 10 May 2011 (not yet published in the Official Journal) and position of the Council at first reading of 4 October 2012 (OJ C 352 E, 16.11.2012, p. 23). Position of the European Parliament of 11 December 2012 (not yet published in the Official Journal). (2) OJ L 145, 31.5.2001, p. 43. (3) OJ L 55, 28.2.2011, p. 13. STATEMENT BY THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE COMMISSION The fact that this Regulation, including recitals 17, 18 and 19, provides for the use of the procedures referred to in Regulation (EU) No 182/2011 does not constitute a precedent as to future regulations allowing the Union to empower the Member States under Article 2(1) TFEU to legislate and adopt legally binding acts in areas of Union exclusive competence. Furthermore, in this Regulation, the use of the advisory as opposed to the examination procedure shall not be considered as setting a precedent for future regulations establishing the framework for the common commercial policy.", "summary": "Bilateral investment agreements \u2014 EU and non-EU countries Bilateral investment agreements \u2014 EU and non-EU countries SUMMARY OF: Regulation (EU) 1219/2012 establishing transitional arrangements for bilateral investment agreements between EU countries and non-EU countries WHAT IS THE AIM OF THIS REGULATION? It aims to ensure a smooth transition from the current system of bilateral investment treaties (BITs) between EU countries and non-EU countries to a system under which BITs are negotiated by the European Commission. This transition is required following the adoption of the Lisbon Treaty. Article 207 of the Treaty on the Functioning of the European Union establishes foreign direct investment as an EU competence as part of the EU\u2019s common commercial policy. KEY POINTS What are bilateral investment treaties? They establish the terms and conditions for private investment by nationals and companies of one country in another one. BITs between an EU country and a non-EU country: BITs signed before 1 December 2009 can, upon authorisation by the Commission, be: maintained in force or enter into force under the conditions of the regulation until a BIT between the EU and a non-EU country comes into force,amended (including to address an inconsistency between the BIT and EU law) or a new agreement can be concluded subject to the conditions set out in the regulation; BITs signed between 1 December 2009 and 9 January 2013 are maintained in force or enter into force if, in the view of the Commission, they do not conflict with other EU law, are not inconsistent with the EU\u2019s principles and are not deemed superfluous in view of Commission negotiations with that non-EU country; if the conditions of the regulation are fulfilled, the Commission may authorise an EU country to enter into negotiation with a non-EU country concerning a new BIT or to sign and conclude a new BIT if the negotiation result is in line with the requirements of the regulation. Oversight The Commission has been given implementing powers to ensure that the regulation is implemented uniformly and is assisted by the Committee for Investment Agreements. The Commission has to present a report on the application of this regulation by 10 January 2020. FROM WHEN DOES THE REGULATION APPLY? It has applied since 9 January 2013. BACKGROUND For more information, see: Investment (European Commission). MAIN DOCUMENT Regulation (EU) No 1219/2012 of the European Parliament and of the Council of 12 December 2012 establishing transitional arrangements for bilateral investment agreements between Member States and third countries (OJ L 351, 20.12.2012, pp. 40-46) RELATED DOCUMENTS Regulation (EU) No 912/2014 of the European Parliament and of the Council of 23 July 2014 establishing a framework for managing financial responsibility linked to investor-to-state dispute settlement tribunals established by international agreements to which the European Union is party (OJ L 257, 28.8.2014, pp. 121-134) List of the bilateral investment agreements referred to in Article 4(1) of Regulation (EU) No 1219/2012 of the European Parliament and of the Council of 12 December 2012 establishing transitional arrangements for bilateral investment agreements between Member States and third countries (OJ C 147, 11.5.2017, pp. 1-105) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L55, 28.2.2011, pp. 13-18) last update 14.12.2017"}
{"article": "31.10.2012 EN Official Journal of the European Union L 303/1 REGULATION (EU) No 978/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 applying a scheme of generalised tariff preferences and repealing Council Regulation (EC) No 732/2008 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Since 1971, the Community has granted trade preferences to developing countries under its scheme of generalised tariff preferences. (2) The Union\u2019s common commercial policy shall be guided by the principles and pursue the objectives set out in the general provisions on the Union\u2019s external action, laid down in Article 21 of the Treaty on European Union (TEU). (3) The Union aims to define and pursue common policies and actions in order to foster the sustainable economic, social and environmental development of developing countries, with the primary aim of eradicating poverty. (4) The Union\u2019s common commercial policy is to be consistent with and to consolidate the objectives of the Union policy in the field of development cooperation, laid down in Article 208 of the Treaty on the Functioning of the European Union (TFEU), in particular the eradication of poverty and the promotion of sustainable development and good governance in the developing countries. It is to comply with World Trade Organisation (WTO) requirements, in particular with the Decision on Differential and More Favourable Treatment, Reciprocity and Fuller Participation of Developing Countries (the \u2018Enabling Clause\u2019), adopted under the General Agreement on Tariffs and Trade (GATT) in 1979, under which WTO Members may accord differential and more favourable treatment to developing countries. (5) The Commission Communication of 7 July 2004 entitled \u2018Developing countries, international trade and sustainable development: the function of the Community\u2019s generalised system of preferences (GSP) for the 10-year period from 2006 to 2015\u2019 sets out the guidelines for the application of the scheme of generalised tariff preferences for the period 2006 to 2015. (6) Council Regulation (EC) No 732/2008 of 22 July 2008 applying a scheme of generalised tariff preferences for the period from 1 January 2009 (2), as extended by Regulation (EU) No 512/2011 of the European Parliament and of the Council of 11 May 2011 amending Council Regulation (EC) No 732/2008 (3) provides for the application of the scheme of generalised tariff preferences (\u2018the scheme\u2019) until 31 December 2013 or until the scheme under this Regulation is applied, whichever is the earlier. Thereafter, the scheme should continue to apply for a period of 10 years from the date of application of the preferences provided for in this Regulation, except for the special arrangement for the least-developed countries, which should continue to be applied without any expiry date. (7) By providing preferential access to the Union market, the scheme should assist developing countries in their efforts to reduce poverty and promote good governance and sustainable development by helping them to generate additional revenue through international trade, which can then be reinvested for the benefit of their own development and, in addition, to diversify their economies. The scheme\u2019s tariff preferences should focus on helping developing countries having greater development, trade and financial needs. (8) The scheme consists of a general arrangement, and two special arrangements. (9) The general arrangement should be granted to all those developing countries which share a common developing need and are in a similar stage of economic development. Countries which are classified by the World Bank as high-income or upper-middle income countries have per capita income levels allowing them to attain higher levels of diversification without the scheme\u2019s tariff preferences. Those countries include economies which have successfully completed their transition from centralised to market economies. They do not share the same development, trade and financial needs as the remaining developing countries; they are at a different stage of economic development, i.e. they are not similarly-situated as the more vulnerable developing countries; and, in order to prevent unjustified discrimination, they need to be treated differently. Furthermore, the use of tariff preferences provided under the scheme by high-income or upper-middle income countries increases the competitive pressure on exports from poorer, more vulnerable countries and therefore could impose unjustifiable burdens on those more vulnerable developing countries. The general arrangement takes account of the fact that the development, trade and financial needs are subject to change and ensures that the arrangement remains open if the situation of a country changes. For the sake of consistency, the tariff preferences granted under the general arrangement should not be extended to developing countries which are benefiting from a preferential market access arrangement with the Union, which provides at least the same level of tariff preferences as the scheme for substantially all trade. To provide a beneficiary country and economic operators with time for an orderly adaptation, the general arrangement should continue to be granted for two years as from the date of application of a preferential market access arrangement and this date should be specified in the list of beneficiary countries of the general arrangement. (10) Countries listed in Annex I to Regulation (EC) No 732/2008 and countries benefiting from autonomous preferential access to the Union market under Regulation (EC) No 732/2008, Council Regulation (EC) No 55/2008 of 21 January 2008 introducing autonomous trade preferences for the Republic of Moldova (4) and Council Regulation (EC) No 2007/2000 of 18 September 2000 introducing exceptional trade measures for countries and territories participating in or linked to the European Union\u2019s Stabilisation and Association process (5) should be considered eligible for the scheme. Overseas territories associated with the Union and overseas countries and territories of countries that are not listed in Annex I to Regulation (EC) No 732/2008 should not be considered eligible for the scheme. (11) The special incentive arrangement for sustainable development and good governance is based on the integral concept of sustainable development, as recognised by international conventions and instruments such as the 1986 United Nations (UN) Declaration on the Right to Development, the 1992 Rio Declaration on Environment and Development, the 1998 International Labour Organisation (ILO) Declaration on Fundamental Principles and Rights at Work, the 2000 UN Millennium Declaration, and the 2002 Johannesburg Declaration on Sustainable Development. Consequently, the additional tariff preferences provided under the special incentive arrangement for sustainable development and good governance should be granted to those developing countries which, due to a lack of diversification and insufficient integration within the international trading system, are vulnerable, in order to help them assume the special burdens and responsibilities resulting from the ratification of core international conventions on human and labour rights, environmental protection and good governance as well as from the effective implementation thereof. (12) Preferences should be designed to promote further economic growth and, thereby, to respond positively to the need for sustainable development. Under the special incentive arrangement, the ad valorem tariffs should therefore be suspended for the beneficiary countries concerned. The specific duties should also be suspended, unless combined with an ad valorem duty. (13) Countries that fulfil the eligibility criteria for the special incentive arrangement for sustainable development and good governance should be able to benefit from the additional tariff preferences if, upon their application, the Commission determines that the relevant conditions are met. It should be possible to submit applications as from the date of entry into force of this Regulation. Countries which benefit from the tariff preferences of the scheme under Regulation (EC) No 732/2008 should also submit a new application. (14) The Commission should monitor the status of ratification of the international conventions on human and labour rights, environmental protection and good governance and their effective implementation, by examining the conclusions and recommendations of the relevant monitoring bodies established under those conventions (the relevant monitoring bodies). Every two years, the Commission should present to the European Parliament and the Council a report on the status of ratification of the respective conventions, the compliance of the beneficiary countries with any reporting obligations under those conventions, and the status of the implementation of the conventions in practice. (15) For the purposes of the monitoring and the withdrawal of preferences, reports from relevant monitoring bodies are essential. However, such reports may be supplemented by other sources of information, provided that they are accurate and reliable. Without prejudice to other sources, this could include information from civil society, social partners, the European Parliament and the Council. (16) The special arrangement for the least-developed countries should continue to grant duty-free access to the Union market for products originating in the least-developed countries, as recognised and classified by the UN, except for trade in arms. For a country no longer classified by the UN as a least-developed country, a transitional period should be established, to alleviate any adverse effects caused by the removal of the tariff preferences granted under this arrangement. Tariff preferences provided under the special arrangement for the least-developed countries should continue to be granted for those least-developed countries, which benefit from another preferential market access arrangement with the Union. (17) To ensure coherence with the market access provisions for sugar in the Economic Partnership Agreements, imports of products under heading 1701 of the Common Customs Tariff should require an import licence until 30 September 2015. (18) As regards the general arrangement, the differentiation between tariff preferences for non-sensitive products and tariff preferences for sensitive products should be maintained, to take account of the situation of the sectors manufacturing the same products in the Union. (19) Common Customs Tariff duties on non-sensitive products should continue to be suspended, while duties on sensitive products should enjoy a tariff reduction, in order to ensure a satisfactory utilisation rate while at the same time taking account of the situation of the corresponding Union industries. (20) Such a tariff reduction should be sufficiently attractive, in order to motivate traders to make use of the opportunities offered by the scheme. Therefore, the ad valorem duties should generally be reduced by a flat rate of 3,5 percentage points from the \u2018most favoured nation\u2019 duty rate, while such duties for textiles and textile goods should be reduced by 20 %. Specific duties should be reduced by 30 %. Where a minimum duty is specified, that minimum duty should not apply. (21) Duties should be suspended totally, where the preferential treatment for an individual import declaration results in an ad valorem duty of 1 % or less or in a specific duty of EUR 2 or less, since the cost of collecting such duties might be higher than the revenue gained. (22) Graduation should be based on criteria related to sections and chapters of the Common Customs Tariff. Graduation should apply in respect of a section or subsection in order to reduce cases where heterogeneous products are graduated. The graduation of a section or a subsection (made up of chapters) for a beneficiary country should be applied when the section meets the criteria for graduation over three consecutive years, in order to increase predictability and fairness of graduation by eliminating the effect of large and exceptional variations in the import statistics. Graduation should not apply to the beneficiary countries of the special incentive arrangement for sustainable development and good governance and the beneficiary countries of the special arrangement for the least-developed countries as they share a very similar economic profile rendering them vulnerable because of a low, non-diversified export base. (23) In order to ensure that the scheme benefits only those countries it is intended to benefit, the tariff preferences provided for by this Regulation should apply, as well as the rules of origin of products, laid down in Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (6). (24) The reasons for temporary withdrawal of the arrangements under the scheme should include serious and systematic violations of the principles laid down in certain international conventions concerning core human rights and labour rights, so as to promote the objectives of those conventions. Tariff preferences under the special incentive arrangement for sustainable development and good governance should be temporarily withdrawn if the beneficiary country does not respect its binding undertaking to maintain the ratification and effective implementation of those conventions or to comply with the reporting requirements imposed by the respective conventions, or if the beneficiary country does not cooperate with the Union\u2019s monitoring procedures as set out in this Regulation. (25) Due to the political situation in Burma/Myanmar and in Belarus, the temporary withdrawal of all tariff preferences in respect of imports of products originating in Burma/Myanmar or Belarus should be maintained. (26) In order to achieve a balance between the need for better targeting, greater coherence and transparency on the one hand, and better promoting sustainable development and good governance through a unilateral trade preference scheme on the other hand, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to the Annexes to this Regulation and temporary withdrawals of tariff preferences due to failure to adhere to the principles of sustainable development and good governance, as well as procedural rules regarding the submission of applications for the tariff preferences granted under the special incentive arrangement for sustainable development and good governance, the conduct of a temporary withdrawal and safeguard investigations in order to establish uniform and detailed technical arrangements. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (27) In order to provide a stable framework for economic operators, the power to adopt an act in accordance with Article 290 TFEU should be delegated to the Commission in respect of repealing a decision on temporary withdrawal under the urgency procedure before that decision to temporarily withdraw tariff preferences takes effect, where the reasons justifying temporary withdrawal no longer apply. (28) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for the control by the Member States of the Commission\u2019s exercise of implementing powers (7). (29) The advisory procedure should be used for the adoption of implementing acts on suspension from the tariff preferences of certain GSP sections in respect of beneficiary countries and on the initiation of a temporary withdrawal procedure, taking into account the nature and impact of those acts. (30) The examination procedure should be used for the adoption of implementing acts on safeguard investigations and on suspension of the preferential arrangements where imports may cause serious disturbance to Union markets. (31) In order to ensure the integrity and orderly functioning of the scheme, the Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to temporary withdrawals due to non-compliance with customs-related procedures and obligations, imperative grounds of urgency so require. (32) In order to provide a stable framework for economic operators, upon conclusion of the maximum period of six months, the Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to termination or extension of the temporary withdrawals due to non-compliance with customs-related procedures and obligations, imperative grounds of urgency so require. (33) The Commission should also adopt immediately applicable implementing acts where, in duly justified cases relating to safeguard investigations, imperative grounds of urgency relating to the deterioration of the economic and/or financial situation of Union producers which would be difficult to repair so require. (34) The Commission should report regularly to the European Parliament and to the Council on the effects of the scheme under this Regulation. Five years after its entry into force, the Commission should report to the European Parliament and to the Council on the application of this Regulation and assess the need to review the scheme, including the special incentive arrangement for sustainable development and good governance and temporary withdrawal provisions of tariff preferences, taking into consideration the fight against terrorism and the field of international standards on transparency and exchange of information in tax matters. In reporting, the Commission should take into account the implications for development, trade and financial needs of beneficiaries. The report should also include a detailed analysis of the impact of this Regulation on trade and on the Union\u2019s tariff income, with particular attention to the effects on beneficiary countries. Where applicable, compliance with Union sanitary and phytosanitary legislation should also be assessed. The report should also include an analysis of the effects of the scheme with regard to imports of biofuels and sustainability aspects. (35) Regulation (EC) No 732/2008 should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 1. The scheme of generalised tariff preferences (the \u2018scheme\u2019) shall apply in accordance with this Regulation. 2. This Regulation provides for the following tariff preferences under the scheme: (a) a general arrangement; (b) a special incentive arrangement for sustainable development and good governance (GSP+); and (c) a special arrangement for the least-developed countries (Everything But Arms (EBA)). Article 2 For the purposes of this Regulation: (a) \u2018GSP\u2019 means the Generalised Scheme of Preferences by which the Union provides preferential access to its market through any of the preferential arrangements referred to in Article 1(2); (b) \u2018countries\u2019 means countries and territories possessing a customs administration; (c) \u2018eligible countries\u2019 means all developing countries as listed in Annex I; (d) \u2018GSP beneficiary countries\u2019 means beneficiary countries of the general arrangement as listed in Annex II; (e) \u2018GSP+ beneficiary countries\u2019 means beneficiary countries of the special incentive arrangement for sustainable development and good governance as listed in Annex III; (f) \u2018EBA beneficiary countries\u2019 means beneficiary countries of the special arrangement for least developed countries as listed in Annex IV; (g) \u2018Common Customs Tariff duties\u2019 means the duties specified in Part Two of Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (8), except those duties established as part of tariff quotas; (h) \u2018section\u2019 means any of the sections of the Common Customs Tariff as laid down by Regulation (EEC) No 2658/87; (i) \u2018chapter\u2019 means any of the chapters of the Common Customs Tariff as laid down by Regulation (EEC) No 2658/87; (j) \u2018GSP section\u2019 means a section listed in Annex V and established on the basis of sections and chapters of the Common Customs Tariff; (k) \u2018preferential market access arrangement\u2019 means preferential access to the Union market through a trade agreement, either provisionally applied or in force, or through autonomous preferences granted by the Union; (l) \u2018effective implementation\u2019 means the integral implementation of all undertakings and obligations undertaken under the international conventions listed in Annex VIII, thus ensuring fulfilment of all the principles, objectives and rights guaranteed therein. Article 3 1. A list of eligible countries is established in Annex I. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 36 to amend Annex I to take account of changes in the international status or classification of countries. 3. The Commission shall notify an eligible country concerned of any relevant changes in its status under the scheme. CHAPTER II GENERAL ARRANGEMENT Article 4 1. An eligible country shall benefit from the tariff preferences provided under the general arrangement referred to in point (a) of Article 1(2) unless: (a) it has been classified by the World Bank as a high-income or an upper-middle income country during three consecutive years immediately preceding the update of the list of beneficiary countries; or (b) it benefits from a preferential market access arrangement which provides the same tariff preferences as the scheme, or better, for substantially all trade. 2. Points (a) and (b) of paragraph 1 shall not apply to least-developed countries. 3. Without prejudice to point (b) of paragraph 1, point (a) of paragraph 1 shall not apply until 21 November 2014, for countries which by 20 November 2012 have initialled a bilateral preferential market access agreement with the Union, which provides the same tariff preferences as the scheme, or better, for substantially all trade, but which is not yet applied. Article 5 1. A list of GSP beneficiary countries meeting the criteria laid down in Article 4 is established in Annex II. 2. By 1 January of each year following the entry into force of this Regulation the Commission shall review Annex II. To provide a GSP beneficiary country and economic operators with time for orderly adaptation to the change in the country\u2019s status under the scheme: (a) the decision to remove a beneficiary country from the list of GSP beneficiary countries, in accordance with paragraph 3 of this Article and on the basis of point (a) of Article 4(1), shall apply as from one year after the date of entry into force of that decision; (b) the decision to remove a beneficiary country from the list of GSP beneficiary countries, in accordance with paragraph 3 of this Article and on the basis of point (b) of Article 4(1), shall apply as from two years after the date of application of a preferential market access arrangement. 3. For the purposes of paragraphs 1 and 2 of this Article the Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex II on the basis of the criteria laid down in Article 4. 4. The Commission shall notify the GSP beneficiary country concerned of any changes in its status under the scheme. Article 6 1. The products included in the general arrangement referred to in point (a) of Article 1(2) are listed in Annex V. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 36, to amend Annex V in order to incorporate changes made necessary by amendments to the Combined Nomenclature. Article 7 1. Common Customs Tariff duties on products listed in Annex V as non-sensitive products shall be suspended entirely, except for agricultural components. 2. Common Customs Tariff ad valorem duties on products listed in Annex V as sensitive products shall be reduced by 3,5 percentage points. For products under GSP sections S-11a and S-11b of Annex V, this reduction shall be 20 %. 3. Where preferential duty rates calculated, in accordance with Article 6 of Regulation (EC) No 732/2008, on the Common Customs Tariff ad valorem duties applicable on the date of entry into force of this Regulation provide for a tariff reduction of more than 3,5 percentage points for the products referred to in paragraph 2 of this Article, those preferential duty rates shall apply. 4. Common Customs Tariff specific duties, other than minimum or maximum duties, on products listed in Annex V as sensitive products shall be reduced by 30 %. 5. Where Common Customs Tariff duties on products listed in Annex V as sensitive products include ad valorem duties and specific duties, the specific duties shall not be reduced. 6. Where duties reduced in accordance with paragraphs 2 and 4 specify a maximum duty, that maximum duty shall not be reduced. Where such duties specify a minimum duty, that minimum duty shall not apply. Article 8 1. The tariff preferences referred to in Article 7 shall be suspended, in respect of products of a GSP section originating in a GSP beneficiary country, when the average value of Union imports of such products over three consecutive years from that GSP beneficiary country exceeds the thresholds listed in Annex VI. The thresholds shall be calculated as a percentage of the total value of Union imports of the same products from all GSP beneficiary countries. 2. Prior to the application of the tariff preferences provided for in this Regulation, the Commission shall adopt an implementing act establishing, in accordance with the advisory procedure referred to in Article 39(2), a list of GSP sections for which the tariff preferences referred to in Article 7 are suspended in respect of a GSP beneficiary country. That implementing act shall apply as from 1 January 2014. 3. The Commission shall, every three years, review the list referred to in paragraph 2 of this Article and adopt an implementing act, in accordance with the advisory procedure referred to in Article 39(2), in order to suspend or to re-establish the tariff preferences referred to in Article 7. That implementing act shall apply as of 1 January of the year following its entry in force. 4. The list referred to in paragraphs 2 and 3 of this Article shall be established on the basis of the data available on 1 September of the year in which the review is conducted and of the two years preceding the review year. It shall take into account imports from GSP beneficiary countries listed in Annex II as applicable at that time. However, the value of imports from GSP beneficiary countries, which upon the date of application of the suspension, no longer benefit from the tariff preferences under point (b) of Article 4(1) shall not be taken into account. 5. The Commission shall notify the country concerned of the implementing act adopted in accordance with paragraphs 2 and 3. 6. Where Annex II is amended in accordance with the criteria laid down in Article 4, the Commission shall be empowered to adopt delegated acts in accordance with Article 36 to amend Annex VI in order to adjust the modalities listed in that Annex so as to maintain proportionally the same weight of the graduated product sections as defined in paragraph 1 of this Article. CHAPTER III SPECIAL INCENTIVE ARRANGEMENT FOR SUSTAINABLE DEVELOPMENT AND GOOD GOVERNANCE Article 9 1. A GSP beneficiary country may benefit from the tariff preferences provided under the special incentive arrangement for sustainable development and good governance referred to in point (b) of Article 1(2) if: (a) it is considered to be vulnerable due to a lack of diversification and insufficient integration within the international trading system, as defined in Annex VII; (b) it has ratified all the conventions listed in Annex VIII (the \u2018relevant conventions\u2019) and the most recent available conclusions of the monitoring bodies under those conventions (the \u2018relevant monitoring bodies\u2019) do not identify a serious failure to effectively implement any of those conventions; (c) in relation to any of the relevant conventions, it has not formulated a reservation which is prohibited by any of those conventions or which is for the purposes of this Article considered to be incompatible with the object and purpose of that convention. For the purposes of this Article, reservations shall not be considered to be incompatible with the object and purpose of a convention unless: (i) a process explicitly set out for that purpose under the convention has so determined; or (ii) in the absence of such a process, the Union where a party to the convention, and/or a qualified majority of Member States party to the convention, in accordance with their respective competences as established in the Treaties, objected to the reservation on the grounds that it is incompatible with the object and purpose of the convention and opposed the entry into force of the convention as between them and the reserving state in accordance with the provisions of the Vienna Convention on the Law of Treaties; (d) it gives a binding undertaking to maintain ratification of the relevant conventions and to ensure the effective implementation thereof; (e) it accepts without reservation the reporting requirements imposed by each convention and gives a binding undertaking to accept regular monitoring and review of its implementation record in accordance with the provisions of the relevant conventions; and (f) it gives a binding undertaking to participate in and cooperate with the monitoring procedure referred to in Article 13. 2. Where Annex II is amended, the Commission shall be empowered to adopt delegated acts in accordance with Article 36 to amend Annex VII in order to review the vulnerability threshold listed in point 1(b) of Annex VII so as to maintain proportionally the same weight of the vulnerability threshold as calculated in accordance with Annex VII. Article 10 1. The special incentive arrangement for sustainable development and good governance shall be granted if the following conditions are met: (a) a GSP beneficiary country has made a request to that effect; and (b) examination of the request shows that the requesting country fulfils the conditions laid down in Article 9(1). 2. The requesting country shall submit its request to the Commission in writing. The request shall provide comprehensive information concerning the ratification of the relevant conventions and shall include the binding undertakings referred to in points (d), (e) and (f) of Article 9(1). 3. After receiving a request, the Commission shall notify the European Parliament and the Council thereof. 4. After examining the request, the Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish or to amend Annex III in order to grant a requesting country the special incentive arrangement for sustainable development and good governance by adding that country to the list of GSP+ beneficiary countries. 5. Where a GSP+ beneficiary country no longer fulfils the conditions referred to in points (a) or (c) of Article 9(1), or withdraws any of its binding undertakings referred to in points (d), (e) and (f) of Article 9(1), the Commission shall be empowered to adopt a delegated act, in accordance with Article 36, to amend Annex III in order to remove that country from the list of GSP+ beneficiary countries. 6. The Commission shall notify the requesting country of a decision taken in accordance with paragraphs 4 and 5 of this Article after Annex III is amended and published in the Official Journal of the European Union. Where the requesting country is granted the special incentive arrangement, it shall be informed of the date on which the respective delegated act enters into force. 7. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish rules related to the procedure for granting the special incentive arrangement for sustainable development and good governance in particular with respect to deadlines and the submission and processing of requests. Article 11 1. The products included in the special incentive arrangement for sustainable development and good governance are listed in Annex IX. 2. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex IX to take into account amendments to the Combined Nomenclature affecting the products listed in that Annex. Article 12 1. The Common Customs Tariff ad valorem duties on all products listed in Annex IX which originate in a GSP+ beneficiary country shall be suspended. 2. Common Customs Tariff specific duties on products referred to in paragraph 1 shall be suspended entirely, except for products for which the Common Customs Tariff duties include ad valorem duties. For products with Combined Nomenclature code 1704 10 90, the specific duty shall be limited to 16 % of the customs value. Article 13 1. As of the date of the granting of the tariff preferences provided under the special incentive arrangement for sustainable development and good governance, the Commission shall keep under review the status of ratification of the relevant conventions and shall monitor their effective implementation, as well as cooperation with the relevant monitoring bodies, by examining the conclusions and recommendations of those monitoring bodies. 2. In this context, a GSP+ beneficiary country shall cooperate with the Commission and provide all information necessary to assess its respect of binding undertakings referred to in points (d), (e) and (f) of Article 9(1) and its situation as regards point (c) of Article 9(1). Article 14 1. By 1 January 2016, and every two years thereafter, the Commission shall present to the European Parliament and to the Council a report on the status of ratification of the relevant conventions, the compliance of the GSP+ beneficiary countries with any reporting obligations under those conventions and the status of the effective implementation thereof. 2. That report shall include: (a) the conclusions or recommendations of relevant monitoring bodies in respect of each GSP+ beneficiary country; and (b) the Commission\u2019s conclusions on whether each GSP+ beneficiary country respects its binding undertakings to comply with reporting obligations, to cooperate with relevant monitoring bodies in accordance with the relevant conventions and to ensure the effective implementation thereof. The report may include any information the Commission considers appropriate. 3. In drawing its conclusions concerning effective implementation of the relevant conventions, the Commission shall assess the conclusions and recommendations of the relevant monitoring bodies, as well as, without prejudice to other sources, information submitted by third parties, including civil society, social partners, the European Parliament or the Council. Article 15 1. The special incentive arrangement for sustainable development and good governance shall be withdrawn temporarily, in respect of all or of certain products originating in a GSP+ beneficiary country, where in practice that country does not respect its binding undertakings as referred to in points (d), (e) and (f) of Article 9(1), or the GSP+ beneficiary country has formulated a reservation which is prohibited by any of the relevant conventions or which is incompatible with the object and purpose of that convention as established in point (c) of Article 9(1). 2. The burden of proof for compliance with its obligations resulting from binding undertakings as referred to in points (d), (e) and (f) of Article 9(1), and its situation as referred to in point (c) of Article 9(1), shall be on the GSP+ beneficiary country. 3. Where, either on the basis of the conclusions of the report referred to in Article 14 or on the basis of the evidence available, the Commission has a reasonable doubt that a particular GSP+ beneficiary country does not respect its binding undertakings as referred to in points (d), (e) and (f) of Article 9(1), or has formulated a reservation which is prohibited by any of the relevant conventions or which is incompatible with the object and purpose of that convention as established in point (c) of Article 9(1), it shall, in accordance with the advisory procedure referred to in Article 39(2), adopt an implementing act to initiate the procedure for the temporary withdrawal of the tariff preferences provided under the special incentive arrangement for sustainable development and good governance. The Commission shall inform the European Parliament and the Council thereof. 4. The Commission shall publish a notice in the Official Journal of the European Union and notify the GSP+ beneficiary country concerned thereof. The notice shall: (a) state the grounds for the reasonable doubt as to the fulfilment of the binding undertakings made by the GSP+ beneficiary country as referred to in points (d), (e) and (f) of Article 9(1), or as to the existence of a reservation which is prohibited by any of the relevant conventions or which is incompatible with the object and purpose of that convention as established in point (c) of Article 9(1), which may call into question its right to continue to enjoy the tariff preferences provided under the special incentive arrangement for sustainable development and good governance; and (b) specify the period, which may not exceed six months from the date of publication of the notice, within which a GSP+ beneficiary country shall submit its observations. 5. The Commission shall provide the beneficiary country concerned with every opportunity to cooperate during the period referred to in point (b) of paragraph 4. 6. The Commission shall seek all information it considers necessary including, inter alia, the conclusions and recommendations of the relevant monitoring bodies. In drawing its conclusions, the Commission shall assess all relevant information. 7. Within three months after expiry of the period specified in the notice, the Commission shall decide: (a) to terminate the temporary withdrawal procedure; or (b) to temporarily withdraw the tariff preferences provided under the special incentive arrangement for sustainable development and good governance. 8. Where the Commission considers that the findings do not justify temporary withdrawal, it shall adopt an implementing act to terminate the temporary withdrawal procedure in accordance with the advisory procedure referred to in Article 39(2). That implementing act shall be based, inter alia, on evidence received. 9. Where the Commission considers that the findings justify temporary withdrawal for the reasons referred to in paragraph 1 of this Article, it shall be empowered, in accordance with Article 36, to adopt delegated acts to amend Annex III in order to temporarily withdraw the tariff preferences provided under the special incentive arrangement for sustainable development and good governance referred to in point (b) of Article 1(2). 10. Where the Commission decides on temporary withdrawal, such delegated act shall take effect six months after its adoption. 11. Where the reasons justifying temporary withdrawal no longer apply before the delegated act referred to in paragraph 9 of this Article takes effect, the Commission shall be empowered to repeal the adopted act to temporarily withdraw tariff preferences in accordance with the urgency procedure referred to in Article 37. 12. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish rules related to the procedure for temporary withdrawal of the special incentive arrangement for sustainable development and good governance in particular with respect to deadlines, rights of parties, confidentiality and review. Article 16 Where the Commission finds that the reasons justifying a temporary withdrawal of the tariff preferences, as referred to in Article 15(1), no longer apply, it shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex III in order to reinstate the tariff preferences provided under the special incentive arrangement for sustainable development and good governance. CHAPTER IV SPECIAL ARRANGEMENT FOR THE LEAST-DEVELOPED COUNTRIES Article 17 1. An eligible country shall benefit from the tariff preferences provided under the special arrangement for the least-developed countries referred to in point (c) of Article 1(2), if that country is identified by the UN as a least-developed country. 2. The Commission shall continuously review the list of EBA beneficiary countries on the basis of the most recent available data. Where an EBA beneficiary country no longer fulfils the conditions referred to in paragraph 1 of this Article, the Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex IV in order to remove the country from the list of EBA beneficiary countries following a transitional period of three years as from the date on which the delegated act entered into force. 3. Pending the identification by the UN of a newly independent country as a least-developed country, the Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex IV as an interim measure so as to include such a country in the list of EBA beneficiary countries. If such a newly independent country is not identified by the UN as a least-developed country during the first available review of the category of least-developed countries, the Commission shall be empowered to adopt delegated acts forthwith, in accordance with Article 36, to amend Annex IV in order to remove such a country from that Annex, without granting the transitional period referred to in paragraph 2 of this Article. 4. The Commission shall notify the EBA beneficiary country concerned of any changes in its status under the scheme. Article 18 1. The Common Customs Tariff duties on all products that are listed in Chapters 1 to 97 of the Combined Nomenclature, except those in Chapter 93, originating in an EBA beneficiary country, shall be suspended entirely. 2. From 1 January 2014 until 30 September 2015, imports of products under tariff heading 1701 of the Common Customs Tariff shall require an import licence. 3. The Commission shall, in accordance with the examination procedure referred to in Article 39(3), adopt detailed rules for implementing the provisions referred to in paragraph 2 of this Article in accordance with the procedure referred to in Article 195 of Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (9). CHAPTER V TEMPORARY WITHDRAWAL PROVISIONS COMMON TO ALL ARRANGEMENTS Article 19 1. The preferential arrangements referred to in Article 1(2) may be withdrawn temporarily, in respect of all or of certain products originating in a beneficiary country, for any of the following reasons: (a) serious and systematic violation of principles laid down in the conventions listed in Part A of Annex VIII; (b) export of goods made by prison labour; (c) serious shortcomings in customs controls on the export or transit of drugs (illicit substances or precursors), or failure to comply with international conventions on anti-terrorism and money laundering; (d) serious and systematic unfair trading practices including those affecting the supply of raw materials, which have an adverse effect on the Union industry and which have not been addressed by the beneficiary country. For those unfair trading practices, which are prohibited or actionable under the WTO Agreements, the application of this Article shall be based on a previous determination to that effect by the competent WTO body; (e) serious and systematic infringement of the objectives adopted by Regional Fishery Organisations or any international arrangements to which the Union is a party concerning the conservation and management of fishery resources. 2. The preferential arrangements provided for in this Regulation shall not be withdrawn under point (d) of paragraph 1 in respect of products that are subject to anti-dumping or countervailing measures under Council Regulation (EC) No 597/2009 of 11 June 2009 on protection against subsidised imports from countries not members of the European Community (10) or Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (11), for the reasons justifying those measures. 3. Where the Commission considers that there are sufficient grounds justifying temporary withdrawal of the tariff preferences provided under any preferential arrangement referred to in Article 1(2) on the basis of the reasons referred to in paragraph 1 of this Article it shall adopt an implementing act to initiate the procedure for temporary withdrawal in accordance with the advisory procedure referred to in Article 39(2). The Commission shall inform the European Parliament and the Council of that implementing act. 4. The Commission shall publish a notice in the Official Journal of the European Union announcing the initiation of a temporary withdrawal procedure, and shall notify the beneficiary country concerned thereof. The notice shall: (a) provide sufficient grounds for the implementing act to initiate a temporary withdrawal procedure, referred to in paragraph 3; and (b) state that the Commission will monitor and evaluate the situation in the beneficiary country concerned for six months from the date of publication of the notice. 5. The Commission shall provide the beneficiary country concerned with every opportunity to cooperate during the monitoring and evaluation period. 6. The Commission shall seek all information it considers necessary, inter alia, the available assessments, comments, decisions, recommendations and conclusions of the relevant monitoring bodies, as appropriate. In drawing its conclusions, the Commission shall assess all relevant information. 7. Within three months from the expiry of the period referred to in point (b) of paragraph 4, the Commission shall submit a report on its findings and conclusions to the beneficiary country concerned. The beneficiary country has the right to submit its comments on the report. The period for comments shall not exceed one month. 8. Within six months from the expiry of the period referred to in point (b) of paragraph 4 the Commission shall decide: (a) to terminate the temporary withdrawal procedure; or (b) to temporarily withdraw the tariff preferences provided under the preferential arrangements referred to in Article 1(2). 9. Where the Commission considers that the findings do not justify temporary withdrawal, it shall adopt an implementing act, in accordance with the advisory procedure referred to in Article 39(2), on the termination of the temporary withdrawal procedure. 10. Where the Commission considers that the findings justify temporary withdrawal for the reasons referred to in paragraph 1 of this Article, it shall be empowered, in accordance with Article 36, to adopt delegated acts to amend Annexes II, III or IV, whichever is applicable, in order to temporarily withdraw the tariff preferences provided under the preferential arrangements referred to in Article 1(2). 11. For either of the cases referred to in paragraphs 9 and 10, the adopted act shall be based, inter alia, on evidence received. 12. Where the Commission decides on temporary withdrawal, such delegated act shall take effect six months after its adoption. 13. Where the reasons justifying temporary withdrawal no longer apply before the delegated act referred to in paragraph 10 of this Article takes effect, the Commission shall be empowered to repeal the adopted act to temporarily withdraw the tariff preferences in accordance with the urgency procedure referred to in Article 37. 14. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish rules related to the procedure for temporary withdrawal of all arrangements in particular with respect to deadlines, rights of parties, confidentiality and review. Article 20 Where the Commission finds that the reasons justifying a temporary withdrawal of the tariff preferences as referred to in Article 19(1) no longer apply, it shall be empowered to adopt delegated acts, in accordance with Article 36 to amend Annexes II, III or IV, whichever is applicable, in order to reinstate the tariff preferences provided under the preferential arrangements referred to in Article 1(2). Article 21 1. The preferential arrangements provided for in this Regulation may be withdrawn temporarily, in respect of all or of certain products originating in a beneficiary country, in cases of fraud, irregularities or systematic failure to comply with or to ensure compliance with the rules concerning the origin of the products and with the procedures related thereto, or failure to provide administrative cooperation as required for the implementation and policing of the preferential arrangements referred to in Article 1(2). 2. The administrative cooperation referred to in paragraph 1 requires, inter alia, that a beneficiary country: (a) communicate to the Commission and update the information necessary for the implementation of the rules of origin and the policing thereof; (b) assist the Union by carrying out, at the request of the customs authorities of the Member States, subsequent verification of the origin of the goods, and communicate its results in time to the Commission; (c) assist the Union by allowing the Commission, in coordination and close cooperation with the competent authorities of the Member States, to conduct the Union administrative and investigative cooperation missions in that country, in order to verify the authenticity of documents or the accuracy of information relevant for granting the preferential arrangements referred to in Article 1(2); (d) carry out or arrange for appropriate inquiries to identify and prevent contravention of the rules of origin; (e) comply with or ensure compliance with the rules of origin in respect of regional cumulation, within the meaning of Regulation (EEC) No 2454/93, if the country benefits therefrom; and (f) assist the Union in the verification of conduct where there is a presumption of origin-related fraud, whereby the existence of fraud may be presumed where imports of products under the preferential arrangements provided for in this Regulation massively exceed the usual levels of the beneficiary country\u2019s exports. 3. Where the Commission considers that there is sufficient evidence to justify temporary withdrawal for the reasons set out in paragraphs 1 and 2 of this Article, it shall decide in accordance with the urgency procedure referred to in Article 39(4) to temporarily withdraw the tariff preferences provided under the preferential arrangements referred to in Article 1(2), in respect of all or certain products originating in a beneficiary country. 4. Before taking such decision, the Commission shall first publish a notice in the Official Journal of the European Union, stating that there are grounds for reasonable doubt about compliance with paragraphs 1 and 2 which may call into question the right of the beneficiary country to continue to enjoy the benefits granted by this Regulation. 5. The Commission shall inform the beneficiary country concerned of any decision taken in accordance with paragraph 3, before it becomes effective. 6. The period of temporary withdrawal shall not exceed six months. At the latest on the conclusion of that period, the Commission shall decide in accordance with the urgency procedure referred to in Article 39(4) either to terminate the temporary withdrawal or to extend the period of temporary withdrawal. 7. Member States shall communicate to the Commission all relevant information that may justify temporary withdrawal of the tariff preferences or its extension. CHAPTER VI SAFEGUARD AND SURVEILLANCE PROVISIONS SECTION I General Safeguards Article 22 1. Where a product originating in a beneficiary country of any of the preferential arrangements referred to in Article 1(2), is imported in volumes and/or at prices which cause, or threaten to cause, serious difficulties to Union producers of like or directly competing products, normal Common Customs Tariff duties on that product may be reintroduced. 2. For the purpose of this Chapter, \u2018like product\u2019 means a product which is identical, i.e. alike in all respects, to the product under consideration, or, in the absence of such a product, another product which, although not alike in all respects, has characteristics closely resembling those of the product under consideration. 3. For the purpose of this Chapter, \u2018interested parties\u2019 means those parties involved in the production, distribution and/or sale of the imports mentioned in paragraph 1 and of like or directly competing products. 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish rules related to the procedure for adopting general safeguard measures in particular with respect to deadlines, rights of parties, confidentiality, disclosure, verification, visits and review. Article 23 Serious difficulties shall be considered to exist where Union producers suffer deterioration in their economic and/or financial situation. In examining whether such deterioration exists, the Commission shall take account, inter alia, of the following factors concerning Union producers, where such information is available: (a) market share; (b) production; (c) stocks; (d) production capacity; (e) bankruptcies; (f) profitability; (g) capacity utilisation; (h) employment; (i) imports; (j) prices. Article 24 1. The Commission shall investigate whether the normal Common Customs Tariff duties should be reintroduced if there is sufficient prima facie evidence that the conditions of Article 22(1) are met. 2. An investigation shall be initiated upon request by a Member State, by any legal person or any association not having legal personality, acting on behalf of Union producers, or on the Commission\u2019s own initiative if it is apparent to the Commission that there is sufficient prima facie evidence, as determined on the basis of factors referred to in Article 23, to justify such initiation. The request to initiate an investigation shall contain evidence that the conditions for imposing the safeguard measure set out in Article 22(1) are met. The request shall be submitted to the Commission. The Commission shall, as far as possible, examine the accuracy and adequacy of the evidence provided in the request to determine whether there is sufficient prima facie evidence to justify the initiation of an investigation. 3. Where it is apparent that there is sufficient prima facie evidence to justify the initiation of proceedings the Commission shall publish a notice in the Official Journal of the European Union. Initiation shall take place within one month of the request received pursuant to paragraph 2. Should an investigation be initiated, the notice shall provide all necessary details about the procedure and deadlines, including recourse to the Hearing Officer of the Directorate-General for Trade of the European Commission. 4. An investigation, including the procedural steps referred to in Articles 25, 26 and 27, shall be concluded within 12 months from its initiation. Article 25 On duly justified grounds of urgency relating to deterioration of the economic and/or financial situation of Union producers, and where delay might cause damage which would be difficult to repair, the Commission shall be empowered to adopt immediately applicable implementing acts in accordance with the urgency procedure referred to in Article 39(4) to reintroduce normal Common Customs Tariff duties for a period of up to 12 months. Article 26 Where the facts as finally established show that the conditions set out in Article 22(1) are met, the Commission shall adopt an implementing act to reintroduce the Common Customs Tariff duties in accordance with the examination procedure referred to in Article 39(3). That implementing act shall enter into force within one month from the date of its publication in the Official Journal of the European Union. Article 27 Where the facts as finally established show that the conditions set out in Article 22(1) are not met, the Commission shall adopt an implementing act terminating the investigation and proceedings in accordance with the examination procedure referred to in Article 39(3). That implementing act shall be published in the Official Journal of the European Union. The investigation shall be deemed terminated, if no implementing act is published within the period referred to in Article 24(4) and any urgent preventive measures shall automatically lapse. Any Common Customs Tariff duties collected as a result of those provisional measures shall be refunded. Article 28 Common Customs Tariff duties shall be reintroduced as long as necessary to counteract the deterioration in the economic and/or financial situation of Union producers, or as long as the threat of such deterioration persists. The period of reintroduction shall not exceed three years, unless it is extended in duly justified circumstances. SECTION II Safeguards in the Textile, Agriculture and Fisheries Sectors Article 29 1. Without prejudice to Section I of this Chapter, on 1 January of each year, the Commission, on its own initiative and in accordance with the advisory procedure referred to in Article 39(2), shall adopt an implementing act in order to remove the tariff preferences referred to in Articles 7 and 12 with respect to the products from GSP sections S-11a and S-11b of Annex V or to products falling under Combined Nomenclature codes 2207 10 00, 2207 20 00, 2909 19 10, 3814 00 90, 3820 00 00, and 3824 90 97 where imports of such products, listed respectively in Annexes V or IX, whichever is applicable, originate in a beneficiary country and their total: (a) increases by at least 13,5 % in quantity (by volume), as compared with the previous calendar year; or (b) for products under GSP sections S-11a and S-11b of Annex V, exceeds the share referred to in point 2 of Annex VI of the value of Union imports of products in GSP sections S-11a and S-11b of Annex V from all countries and territories listed in Annex II during any period of 12 months. 2. Paragraph 1 of this Article shall not apply to EBA beneficiary countries, nor shall it apply to countries with a share for the relevant products referred to in Article 29(1) not exceeding 6 % of total Union imports of the same products listed in Annexes V or IX, whichever is applicable. 3. The removal of the tariff preferences shall take effect two months after the date of publication of the Commission\u2019s act to that effect in the Official Journal of the European Union. Article 30 Without prejudice to Section I of this Chapter, where imports of products included in Annex I to the TFEU cause, or threaten to cause, serious disturbance to Union markets, in particular to one or more of the outermost regions, or these markets\u2019 regulatory mechanisms, the Commission, on its own initiative or at the request of a Member State, after consulting the committee for the relevant agriculture or fisheries common market organisation, shall adopt an implementing act in order to suspend the preferential arrangements in respect of the products concerned in accordance with examination procedure referred to in Article 39(3). Article 31 The Commission shall inform the beneficiary country concerned as soon as possible of any decision taken in accordance with Articles 29 or 30 before it becomes effective. SECTION III Surveillance in the Agricultural and Fisheries Sectors Article 32 1. Without prejudice to Section I of this Chapter, products from Chapters 1 to 24 of the Common Customs Tariff as laid down by Regulation (EEC) No 2658/87, originating in beneficiary countries, may be subject to a special surveillance mechanism, in order to avoid disturbances to Union markets. The Commission, on its own initiative or at the request of a Member State, after consulting the committee for the relevant agriculture or fisheries common market organisation, shall adopt an implementing act, in accordance with the examination procedure referred to in Article 39(3), on whether to apply this special surveillance mechanism, and shall determine the products to which this surveillance mechanism is to be applied. 2. Where Section I of this Chapter is applied to products in Chapters 1 to 24 of the Common Customs Tariff as laid down by Regulation (EEC) No 2658/87, originating in beneficiary countries, the period referred to in Article 24(4) of this Regulation shall be reduced to two months in the following cases: (a) when the beneficiary country concerned does not ensure compliance with the rules of origin or does not provide the administrative cooperation referred to in Article 21; or (b) when imports of products from Chapters 1 to 24 of the Common Customs Tariff as laid down by Regulation (EEC) No 2658/87, under the preferential arrangements granted under this Regulation massively exceed the usual levels of exports from the beneficiary country concerned. CHAPTER VII COMMON PROVISIONS Article 33 1. To benefit from the tariff preferences, the products for which the tariff preferences are claimed shall originate in a beneficiary country. 2. For the purposes of the preferential arrangements referred to in Article 1(2) of this Regulation, the rules of origin concerning the definition of the concept of originating products, the procedures and the methods of administrative cooperation related thereto shall be those laid down in Regulation (EEC) No 2454/93. Article 34 1. Where the rate of an ad valorem duty for an individual import declaration is reduced in accordance with this Regulation to 1 % or less, that duty shall be suspended entirely. 2. Where the rate of a specific duty for an individual import declaration is reduced in accordance with this Regulation to EUR 2 or less per individual euro amount, that duty shall be suspended entirely. 3. Subject to paragraphs 1 and 2, the final rate of the preferential duty calculated in accordance with this Regulation shall be rounded down to the first decimal place. Article 35 1. The statistical source to be used for the purpose of this Regulation shall be the external trade statistics of the Commission (Eurostat). 2. Member States shall send the Commission (Eurostat) their statistical data on products placed under the customs procedure for release for free circulation under the tariff preferences according to Regulation (EC) No 471/2009 of the European Parliament and of the Council of 6 May 2009 on Community statistics relating to external trade with non-member countries (12). Those data, supplied by reference to the Combined Nomenclature codes and, where applicable, the TARIC codes, shall show, by country of origin, the values, quantities and any supplementary units required in accordance with the definitions in that Regulation. In accordance with Article 8(1) of that Regulation, Member States shall transmit those statistical data no later than 40 days after the end of each monthly reference period. In order to facilitate information and increase transparency, the Commission shall also ensure that the relevant statistical data for the GSP sections are regularly available in a public database. 3. In accordance with Article 308d of Regulation (EEC) No 2454/93, Member States shall forward to the Commission, at its request, details of the quantities and values of products released for free circulation under the tariff preferences, during the previous months. Those data shall include the products referred to in paragraph 4 of this Article. 4. The Commission shall, in close cooperation with Member States, monitor the imports of products falling under Combined Nomenclature codes 0603, 0803 90 10, 1006, 1604 14, 1604 19 31, 1604 19 39, 1604 20 70, 1701, 1704, 1806 10 30, 1806 10 90, 2002 90, 2103 20, 2106 90 59, 2106 90 98, 6403, 2207 10 00, 2207 20 00, 2909 19 10, 3814 00 90, 3820 00 00 and 3824 90 97, in order to determine whether the conditions referred to in Articles 22, 29 and 30 are fulfilled. Article 36 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 3, 5, 6, 8, 9, 10, 11, 15, 16, 17, 19, 20 and 22 shall be conferred to the Commission for an indeterminate period of time from 20 November 2012. 3. The delegation of powers referred to in Articles 3, 5, 6, 8, 9, 10, 11, 15, 16, 17, 19, 20 or 22 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 3, 5, 6, 8, 9, 10, 11, 15, 16, 17, 19, 20 or 22 shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. Article 37 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act adopted under this Article to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 36(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council. Article 38 1. Information received pursuant to this Regulation shall be used only for the purpose for which it was requested. 2. Neither information of a confidential nature nor any information provided on a confidential basis received pursuant to this Regulation shall be disclosed without specific permission from the supplier of such information. 3. Each request for confidentiality shall state the reasons why the information is confidential. However, if the supplier of the information wishes neither to make it public nor to authorise its disclosure in general terms or in the form of a summary and if it appears that the request for confidentiality is unjustified, the information concerned may be disregarded. 4. Information shall in any case be considered to be confidential if its disclosure is likely to have a significantly adverse effect upon the supplier or the source of such information. 5. Paragraphs 1 to 4 shall not preclude reference by the Union authorities to general information and in particular to reasons on which decisions taken pursuant to this Regulation are based. Those authorities shall, however, take into account the legitimate interests of natural and legal persons concerned so that their business secrets shall not be divulged. Article 39 1. The Commission shall be assisted by the Generalised Preferences Committee established by Regulation (EC) No 732/2008. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. The Committee may examine any matter relating to the application of this Regulation, raised by the Commission or at the request of a Member State. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 shall apply in conjunction with Article 5 thereof. Article 40 By 1 January 2016 and every two years thereafter, the Commission shall submit to the European Parliament and to the Council a report on the effects of the scheme covering the most recent two-year period and all of the preferential arrangements referred to in Article 1(2). By 21 November 2017, the Commission shall submit, to the European Parliament and to the Council, a report on the application of this Regulation. Such a report may, where appropriate, be accompanied by a legislative proposal. Article 41 Regulation (EC) No 732/2008 is repealed with effect from 1 January 2014. References to the repealed Regulation shall be construed as references to this Regulation in accordance with the correlation table set out in Annex X. CHAPTER VIII FINAL PROVISIONS Article 42 1. Any investigation or temporary withdrawal procedure initiated and not terminated under Regulation (EC) No 732/2008 shall be reinitiated automatically under this Regulation, except in respect of a beneficiary country of the special incentive arrangement for sustainable development and good governance under that Regulation if the investigation concerns only the benefits granted under the special incentive arrangement for sustainable development and good governance. However, such investigation shall be reinitiated automatically if the same beneficiary country applies for the special incentive arrangement under this Regulation before 1 January 2015. 2. The information received in the course of an investigation initiated and not terminated under Regulation (EC) No 732/2008 shall be taken into account in any reinitiated investigation. Article 43 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 20 November 2012. However, the tariff preferences provided under the preferential arrangements referred to in Article 1(2) shall apply from 1 January 2014. 3. The scheme shall apply until 31 December 2023. However, the expiry date shall neither apply to the special arrangement for the least-developed countries, nor, to the extent that they are applied in conjunction with that arrangement, to any other provisions of this Regulation. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 October 2012. For the European Parliament The President Martin SCHULZ For the Council The President A. D. MAVROYIANNIS (1) Position of the European Parliament of 13 June 2012 (not yet published in the Official Journal) and decision of the Council of 4 October 2012. (2) OJ L 211, 6.8.2008, p. 1. (3) OJ L 145, 31.5.2011, p. 28. (4) OJ L 20, 24.1.2008, p. 1. (5) OJ L 240, 23.9.2000, p. 1. (6) OJ L 253, 11.10.1993, p. 1. (7) OJ L 55, 28.2.2011, p. 13. (8) OJ L 256, 7.9.1987, p. 1. (9) OJ L 299, 16.11.2007, p. 1. (10) OJ L 188, 18.7.2009, p. 93. (11) OJ L 343, 22.12.2009, p. 51. (12) OJ L 152, 16.6.2009, p. 23. LIST OF ANNEXES Annex I \u2014 Eligible countries of the scheme referred to in Article 3 Annex II \u2014 Beneficiary countries of the general arrangement referred to in point (a) of Article 1(2) Annex III \u2014 Beneficiary countries of the special incentive arrangement for sustainable development and good governance referred to in point (b) of Article 1(2) Annex IV \u2014 Beneficiary countries of the special arrangement for the least-developed countries referred to in point (c) of Article 1(2) Annex V \u2014 List of products included in the general arrangement referred to in point (a) of Article 1(2) Annex VI \u2014 Modalities for the application of Article 8 Annex VII \u2014 Modalities for the application of Chapter III of this Regulation Annex VIII \u2014 Conventions referred to in Article 9 Annex IX \u2014 List of products included in the special incentive arrangement for sustainable development and good governance referred to in point (b) of Article 1(2) Annex X \u2014 Correlation table ANNEX I Eligible countries (1) of the scheme referred to in Article 3 Column A : alphabetical code, in accordance with the nomenclature of countries and territories for the Union external trade statistics Column B : name A B AE United Arab Emirates AF Afghanistan AG Antigua and Barbuda AL Albania AM Armenia AO Angola AR Argentina AZ Azerbaijan BA Bosnia and Herzegovina BB Barbados BD Bangladesh BF Burkina Faso BH Bahrain BI Burundi BJ Benin BN Brunei BO Bolivia BR Brazil BS Bahamas BT Bhutan BW Botswana BY Belarus BZ Belize CD Democratic Republic of the Congo CF Central African Republic CG Congo CI C\u00f4te d\u2019Ivoire CK Cook Islands CL Chile CM Cameroon CN China CO Colombia CR Costa Rica CU Cuba CV Cape Verde DJ Djibouti DM Dominica DO Dominican Republic DZ Algeria EC Ecuador EG Egypt ER Eritrea ET Ethiopia FJ Fiji FM Micronesia GA Gabon GD Grenada GE Georgia GH Ghana GM Gambia, The GN Guinea GQ Equatorial Guinea GT Guatemala GW Guinea-Bissau GY Guyana HK Hong Kong HN Honduras HR Croatia HT Haiti ID Indonesia IN India IQ Iraq IR Iran JM Jamaica JO Jordan KE Kenya KG Kyrgyzstan KH Cambodia KI Kiribati KM Comoros KN Saint Kitts and Nevis KW Kuwait KZ Kazakhstan LA Laos LB Lebanon LC Saint Lucia LK Sri Lanka LR Liberia LS Lesotho LY Libya MA Morocco MD Moldova ME Montenegro MG Madagascar MH Marshall Islands MK former Yugoslav Republic of Macedonia, the ML Mali MM Burma/Myanmar MN Mongolia MO Macao MR Mauritania MU Mauritius MV Maldives MW Malawi MX Mexico MY Malaysia MZ Mozambique NA Namibia NE Niger NG Nigeria NI Nicaragua NP Nepal NR Nauru NU Niue OM Oman PA Panama PE Peru PG Papua New Guinea PH Philippines PK Pakistan PW Palau PY Paraguay QA Qatar RS Serbia RU Russia RW Rwanda SA Saudi Arabia SB Solomon Islands SC Seychelles SD Sudan SL Sierra Leone SN Senegal SO Somalia SR Suriname ST S\u00e3o Tom\u00e9 and Pr\u00edncipe SV El Salvador SY Syria SZ Swaziland TD Chad TG Togo TH Thailand TJ Tajikistan TL Timor-Leste TM Turkmenistan TN Tunisia TO Tonga TT Trinidad and Tobago TV Tuvalu TZ Tanzania UA Ukraine UG Uganda UY Uruguay UZ Uzbekistan VC Saint Vincent and the Grenadines VE Venezuela VN Vietnam VU Vanuatu WS Samoa XK Kosovo (2) YE Yemen ZA South Africa ZM Zambia ZW Zimbabwe Eligible countries of the scheme referred to in Article 3 which have been temporarily withdrawn from the scheme, in respect of all or of certain products originating in these countries Column A : alphabetical code, in accordance with the nomenclature of countries and territories for the Union external trade statistics Column B : name A B BY Belarus MM Burma/Myanmar (1) This list includes countries for which preferences may have been temporarily withdrawn or suspended. The Commission or the competent authorities of the country concerned will be able to provide an updated list. (2) This designation is without prejudice to positions on status, and is in line with UN Security Council Resolution 1244 (1999) and the International Court of Justice Opinion on the Kosovo\u2019s declaration of independence. ANNEX II Beneficiary countries (1) of the general arrangement referred to in point (a) of Article 1(2) Column A : alphabetical code, in accordance with the nomenclature of countries and territories for the Union external trade statistics Column B : name A B AF Afghanistan AM Armenia AO Angola AZ Azerbaijan BD Bangladesh BF Burkina Faso BI Burundi BJ Benin BO Bolivia BT Bhutan CD Democratic Republic of the Congo CF Central African Republic CG Congo CK Cook Islands CN China CO Colombia CR Costa Rica CV Cape Verde DJ Djibouti EC Ecuador ER Eritrea ET Ethiopia FM Micronesia GE Georgia GM Gambia, The GN Guinea GQ Equatorial Guinea GT Guatemala GW Guinea-Bissau HN Honduras HT Haiti ID Indonesia IN India IQ Iraq IR Iran KG Kyrgyzstan KH Cambodia KI Kiribati KM Comoros LA Laos LK Sri Lanka LR Liberia LS Lesotho MG Madagascar MH Marshall Islands ML Mali MM Burma/Myanmar MN Mongolia MR Mauritania MV Maldives MW Malawi MZ Mozambique NE Niger NG Nigeria NI Nicaragua NP Nepal NR Nauru NU Niue PA Panama PE Peru PH Philippines PK Pakistan PY Paraguay RW Rwanda SB Solomon Islands SD Sudan SL Sierra Leone SN Senegal SO Somalia ST S\u00e3o Tom\u00e9 and Pr\u00edncipe SV El Salvador SY Syria TD Chad TG Togo TH Thailand TJ Tajikistan TL Timor-Leste TM Turkmenistan TO Tonga TV Tuvalu TZ Tanzania UA Ukraine UG Uganda UZ Uzbekistan VN Vietnam VU Vanuatu WS Samoa YE Yemen ZM Zambia Beneficiary countries of the general arrangement referred to in point (a) of Article 1(2) which have been temporarily withdrawn from that arrangement, in respect of all or of certain products originating in these countries Column A : alphabetical code, in accordance with the nomenclature of countries and territories for the Union external trade statistics Column B : name A B MM Burma/Myanmar (1) This list includes countries for which preferences may have been temporarily withdrawn or suspended. The Commission or the competent authorities of the country concerned will be able to provide an updated list. ANNEX III Beneficiary countries (1) of the special incentive arrangement for sustainable development and good governance referred to in point (b) of Article 1(2) Column A : alphabetical code, in accordance with the nomenclature of countries and territories for the Union external trade statistics Column B : name A B Beneficiary countries of the special incentive arrangement for sustainable development and good governance referred to in point (b) of Article 1(2) which have been temporarily withdrawn from that arrangement, in respect of all or of certain products originating in these countries Column A : alphabetical code, in accordance with the nomenclature of countries and territories for the Union external trade statistics Column B : name A B (1) This list includes countries for which preferences may have been temporarily withdrawn or suspended. The Commission or the competent authorities of the country concerned will be able to provide an updated list. ANNEX IV Beneficiary countries (1) of the special arrangement for the least-developed countries referred to in point (c) of Article 1(2) Column A : alphabetical code, in accordance with the nomenclature of countries and territories for the Union external trade statistics Column B : name A B AF Afghanistan AO Angola BD Bangladesh BF Burkina Faso BI Burundi BJ Benin BT Bhutan CD Democratic Republic of the Congo CF Central African Republic DJ Djibouti ER Eritrea ET Ethiopia GM Gambia, The GN Guinea GQ Equatorial Guinea GW Guinea-Bissau HT Haiti KH Cambodia KI Kiribati KM Comoros LA Laos LR Liberia LS Lesotho MG Madagascar ML Mali MM Burma/Myanmar MR Mauritania MV Maldives MW Malawi MZ Mozambique NE Niger NP Nepal RW Rwanda SB Solomon Islands SD Sudan SL Sierra Leone SN Senegal SO Somalia ST S\u00e3o Tom\u00e9 and Pr\u00edncipe TD Chad TG Togo TL Timor-Leste TV Tuvalu TZ Tanzania UG Uganda VU Vanuatu WS Samoa YE Yemen ZM Zambia Beneficiary countries of the special arrangement for the least-developed countries referred to in point (c) of Article 1(2) which have been temporarily withdrawn from that arrangement, in respect of all or of certain products originating in these countries Column A : alphabetical code, in accordance with the nomenclature of countries and territories for the Union external trade statistics Column B : name A B MM Burma/Myanmar (1) This list includes countries for which preferences may have been temporarily withdrawn or suspended. The Commission or the competent authorities of the country concerned will be able to provide an updated list. ANNEX V List of products included in the general arrangement referred to in point (a) of Article 1(2) Notwithstanding the rules for the interpretation of the Combined Nomenclature (\u2018CN\u2019), the description of the products is to be considered as indicative, the tariff preferences being determined by the CN codes. Where \u2018ex\u2019 CN codes are indicated, the tariff preferences are to be determined by the CN code and the description, together. Entry of products with a CN code marked with an asterisk (*) is subject to the conditions laid down in the relevant Union law. The column \u2018Section\u2019 lists GSP sections (Article 2(h)) The column \u2018Chapter\u2019 lists CN chapters covered by a GSP section (Article 2(i)) The column \u2018Sensitive/non-sensitive\u2019 refers to the products included in the general arrangement (Article 6). These products are listed as being either NS (non-sensitive, for the purposes of Article 7(1)) or S (sensitive, for the purposes of Article 7(2)). For reasons of simplification, the products are listed in groups. These may include products for which Common Customs Tariff duties were withdrawn or suspended. Section Chapter CN code Description Sensitive/non-sensitive S-1a 01 0101 29 90 Live horses, other than pure-bred breeding animals, other than for slaughter S 0101 30 00 Live asses S 0101 90 00 Live mules and hinnies S 0104 20 10* Live, pure-bred breeding goats S 0106 14 10 Live domestic rabbits S 0106 39 10 Live pigeons S 02 0205 00 Meat of horses, asses, mules or hinnies, fresh, chilled or frozen S 0206 80 91 Edible offal of horses, asses, mules or hinnies, fresh or chilled, other than for the manufacture of pharmaceutical products S 0206 90 91 Edible offal of horses, asses, mules or hinnies, frozen, other than for the manufacture of pharmaceutical products S 0207 14 91 Livers, frozen, of fowls of the species Gallus domesticus S 0207 27 91 Livers, frozen, of turkeys S 0207 45 95 0207 55 95 0207 60 91 Livers, frozen, of ducks, geese or guinea fowls, other than fatty livers of ducks or geese S 0208 90 70 Frogs\u2019 legs NS 0210 99 10 Meat of horses, salted, in brine or dried S 0210 99 59 Offal of bovine animals, salted, in brine, dried or smoked, other than thick skirt and thin skirt S ex 0210 99 85 Offal of sheep or goats, salted, in brine, dried or smoked S ex 0210 99 85 Offal, salted, in brine, dried or smoked, other than poultry liver, other than of domestic swine, of bovine animals or of sheep or goats S 04 0403 10 51 Yogurt, flavoured or containing added fruit, nuts or cocoa S 0403 10 53 0403 10 59 0403 10 91 0403 10 93 0403 10 99 0403 90 71 Buttermilk, curdled milk and cream, kephir and other fermented or acidified milk and cream, flavoured or containing added fruit, nuts or cocoa S 0403 90 73 0403 90 79 0403 90 91 0403 90 93 0403 90 99 0405 20 10 Dairy spreads, of a fat content, by weight, of 39 % or more but not exceeding 75 % S 0405 20 30 0407 19 90 0407 29 90 0407 90 90 Birds\u2019 eggs, in shell, fresh, preserved or cooked, other than of poultry S 0410 00 00 Edible products of animal origin, not elsewhere specified or included S 05 0511 99 39 Natural sponges of animal origin, other than raw S S-1b 03 ex Chapter 3 Fish and crustaceans, molluscs and other aquatic invertebrates, except for products under subheading 0301 19 00 S 0301 19 00 Live, ornamental saltwater fish NS S-2a 06 ex Chapter 6 Live trees and other plants; bulbs, roots and the like; cut flowers and ornamental foliage, except for products under subheading 0603 12 00 and 0604 20 40 S 0603 12 00 Fresh cut carnations and buds of a kind suitable for bouquets or for ornamental purposes NS 0604 20 40 Conifer branches, fresh NS S-2b 07 0701 Potatoes, fresh or chilled S 0703 10 Onions and shallots, fresh or chilled S 0703 90 00 Leeks and other alliaceous vegetables, fresh or chilled S 0704 Cabbages, cauliflowers, kohlrabi, kale and similar edible brassicas, fresh or chilled S 0705 Lettuce (Lactuca sativa) and chicory (Cichorium spp.), fresh or chilled S 0706 Carrots, turnips, salad beetroot, salsify, celeriac, radishes and similar edible roots, fresh or chilled S ex 0707 00 05 Cucumbers, fresh or chilled, from 16 May to 31 October S 0708 Leguminous vegetables, shelled or unshelled, fresh or chilled S 0709 20 00 Asparagus, fresh or chilled S 0709 30 00 Aubergines (eggplants), fresh or chilled S 0709 40 00 Celery other than celeriac, fresh or chilled S 0709 51 00 ex 0709 59 Mushrooms, fresh or chilled, excluding the products under subheading 0709 59 50 S 0709 60 10 Sweet peppers, fresh or chilled S 0709 60 99 Fruits of the genus Capsicum or of the genus Pimenta, fresh or chilled, other than sweet peppers, other than for the manufacture of capsaicin or capsicum oleoresin dyes and other than for the industrial manufacture of essential oils or resinoids S 0709 70 00 Spinach, New Zealand spinach and orache spinach (garden spinach), fresh or chilled S ex 0709 91 00 Globe artichokes, fresh or chilled, from 1 July to 31 October S 0709 92 10* Olives, fresh or chilled, for uses other than the production of oil S 0709 93 10 Courgettes, fresh or chilled S 0709 93 90 0709 99 90 Other vegetables, fresh or chilled S 0709 99 10 Salad vegetables, fresh or chilled, other than lettuce (Lactuca sativa) and chicory (Cichorium spp.) S 0709 99 20 Chard (or white beet) and cardoons, fresh or chilled S 0709 99 40 Capers, fresh or chilled S 0709 99 50 Fennel, fresh or chilled S ex 0710 Vegetables (uncooked or cooked by steaming or boiling in water), frozen, except for the product of subheading 0710 80 85 S ex 0711 Vegetables provisionally preserved (for example, by sulphur dioxide gas, in brine, in sulphur water or in other preservative solutions), but unsuitable in that state for immediate consumption, excluding the products under subheading 0711 20 90 S ex 0712 Dried vegetables, whole, cut, sliced, broken or in powder, but not further prepared, excluding olives and the products under subheading 0712 90 19 S 0713 Dried leguminous vegetables, shelled, whether or not skinned or split S 0714 20 10* Sweet potatoes, fresh, whole, and intended for human consumption NS 0714 20 90 Sweet potatoes, fresh, chilled, frozen or dried, whether or not sliced or in the form of pellets, other than fresh and whole and intended for human consumption S 0714 90 90 Jerusalem artichokes and similar roots and tubers with high inulin content, fresh, chilled, frozen or dried, whether or not sliced or in the form of pellets; sago pith NS 08 0802 11 90 Almonds, fresh or dried, whether or not shelled, other than bitter S 0802 12 90 0802 21 00 Hazelnuts or filberts (Corylus spp.), fresh or dried, whether or not shelled S 0802 22 00 0802 31 00 Walnuts, fresh or dried, whether or not shelled S 0802 32 00 0802 41 00 0802 42 00 Chestnuts (Castanea spp.), fresh or dried, whether or not shelled or peeled S 0802 51 00 0802 52 00 Pistachios, fresh or dried, whether or not shelled or peeled NS 0802 61 00 0802 62 00 Macadamia nuts, fresh or dried, whether or not shelled or peeled NS 0802 90 50 Pine nuts, fresh or dried, whether or not shelled or peeled NS 0802 90 85 Other nuts, fresh or dried, whether or not shelled or peeled NS 0803 10 10 Plantains, fresh S 0803 10 90 0803 90 90 Bananas, including plantains, dried S 0804 10 00 Dates, fresh or dried S 0804 20 10 Figs, fresh or dried S 0804 20 90 0804 30 00 Pineapples, fresh or dried S 0804 40 00 Avocados, fresh or dried S ex 0805 20 Mandarins (including tangerines and satsumas), and clementines, wilkings and similar citrus hybrids, fresh or dried, from 1 March to 31 October S 0805 40 00 Grapefruit, including pomelos, fresh or dried NS 0805 50 90 Limes (Citrus aurantifolia, Citrus latifolia), fresh or dried S 0805 90 00 Other citrus fruit, fresh or dried S ex 0806 10 10 Table grapes, fresh, from 1 January to 20 July and from 21 November to 31 December, excluding grapes of the variety Emperor (Vitis vinifera cv.) from 1 to 31 December S 0806 10 90 Other grapes, fresh S ex 0806 20 Dried grapes, excluding products under subheading ex 0806 20 30 in immediate containers of a net capacity exceeding 2 kg S 0807 11 00 Melons (including watermelons), fresh S 0807 19 00 0808 10 10 Cider apples, fresh, in bulk, from 16 September to 15 December S 0808 30 10 Perry pears, fresh, in bulk, from 1 August to 31 December S ex 0808 30 90 Other pears, fresh, from 1 May to 30 June S 0808 40 00 Quinces, fresh S ex 0809 10 00 Apricots, fresh, from 1 January to 31 May and from 1 August to 31 December S 0809 21 00 Sour cherries (Prunus cerasus), fresh S ex 0809 29 Cherries, fresh, from 1 January to 20 May and from 11 August to 31 December, other than sour cherries (Prunus cerasus) S ex 0809 30 Peaches, including nectarines, fresh, from 1 January to 10 June and from 1 October to 31 December S ex 0809 40 05 Plums, fresh, from 1 January to 10 June and from 1 October to 31 December S 0809 40 90 Sloes, fresh S ex 0810 10 00 Strawberries, fresh, from 1 January to 30 April and from 1 August to 31 December S 0810 20 Raspberries, blackberries, mulberries and loganberries, fresh S 0810 30 00 Black-, white- or redcurrants and gooseberries, fresh S 0810 40 30 Fruit of the species Vaccinium myrtillus, fresh S 0810 40 50 Fruit of the species Vaccinium macrocarpon and Vaccinium corymbosum, fresh S 0810 40 90 Other fruits of the genus Vaccinium, fresh S 0810 50 00 Kiwifruit, fresh S 0810 60 00 Durians, fresh S 0810 70 00 Persimmons S 0810 90 75 Other fruit, fresh ex 0811 Fruit and nuts, uncooked or cooked by steaming or boiling in water, frozen, whether or not containing added sugar or other sweetening matter, except for products under subheadings 0811 10 and 0811 20 S ex 0812 Fruit and nuts, provisionally preserved (for example, by sulphur dioxide gas, in brine, in sulphur water or in other preservative solutions), but unsuitable in that state for immediate consumption, except for products under subheading 0812 90 30 S 0812 90 30 Papaws (papayas) NS 0813 10 00 Apricots, dried S 0813 20 00 Prunes S 0813 30 00 Apples, dried S 0813 40 10 Peaches, including nectarines, dried S 0813 40 30 Pears, dried S 0813 40 50 Papaws (papayas), dried NS 0813 40 95 Other fruit, dried, other than that of headings 0801 to 0806 NS 0813 50 12 Mixtures of dried fruit (other than that of headings 0801 to 0806) of papaws (papayas), tamarinds, cashew apples, lychees, jackfruit, sapodilla plums, passion fruit, carambola or pitahaya, but not containing prunes S 0813 50 15 Other mixtures of dried fruit (other than that of headings 0801 to 0806), not containing prunes S 0813 50 19 Mixtures of dried fruit (other than that of headings 0801 to 0806), containing prunes S 0813 50 31 Mixtures exclusively of tropical nuts of headings 0801 and 0802 S 0813 50 39 Mixtures exclusively of nuts of headings 0801 and 0802, other than of tropical nuts S 0813 50 91 Other mixtures of nuts and dried fruits of Chapter 8, not containing prunes or figs S 0813 50 99 Other mixtures of nuts and dried fruits of Chapter 8 S 0814 00 00 Peel of citrus fruit or melons (including watermelons), fresh, frozen, dried or provisionally preserved in brine, in sulphur water or in other preservative solutions NS S-2c 09 ex Chapter 9 Coffee, tea, mat\u00e9 and spices, except the products under subheadings 0901 12 00, 0901 21 00, 0901 22 00, 0901 90 90 and 0904 21 10, headings 0905 00 00 and 0907 00 00, and subheadings 0910 91 90, 0910 99 33, 0910 99 39, 0910 99 50 and 0910 99 99 NS 0901 12 00 Coffee, not roasted, decaffeinated S 0901 21 00 Coffee, roasted, not decaffeinated S 0901 22 00 Coffee, roasted, decaffeinated S 0901 90 90 Coffee substitutes containing coffee in any proportion S 0904 21 10 Sweet peppers, dried, neither crushed nor ground S 0905 Vanilla S 0907 Cloves (whole fruit, cloves and stems) S 0910 91 90 Mixtures of two or more products under different headings of headings 0904 to 0910, crushed or ground S 0910 99 33 Thyme; bay leaves S 0910 99 39 0910 99 50 0910 99 99 Other spices, crushed or ground, other than mixtures of two or more products under different headings of headings 0904 to 0910 S S-2d 10 1008 50 00 Quinoa (Chenopodium quinoa) S 11 1104 29 17 Hulled cereal grains excluding barley, oats, maize, rice and wheat S 1105 Flour, meal, powder, flakes, granules and pellets of potatoes S 1106 10 00 Flour, meal and powder of the dried leguminous vegetables of heading 0713 S 1106 30 Flour, meal and powder of products from Chapter 8 S 1108 20 00 Inulin S 12 ex Chapter 12 Oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruit, except for products under subheadings 1209 21 00, 1209 23 80, 1209 29 50, 1209 29 80, 1209 30 00, 1209 91 80 and 1209 99 91; industrial or medicinal plants, except for products under subheading 1211 90 30, and excluding products under heading 1210 and subheadings 1212 91 and 1212 93 00 S 1209 21 00 Lucerne (alfalfa) seed, of a kind used for sowing NS 1209 23 80 Other fescue seed, of a kind used for sowing NS 1209 29 50 Lupine seed, of a kind used for sowing NS 1209 29 80 Seeds of other forage plants, of a kind used for sowing NS 1209 30 00 Seeds of herbaceous plants cultivated principally for their flowers, of a kind used for sowing NS 1209 91 80 Other vegetable seeds, of a kind used for sowing NS 1209 99 91 Seeds of plants cultivated principally for their flowers, of a kind used for sowing, other than those of subheading 1209 30 00 NS 1211 90 30 Tonquin beans, fresh or dried, whether or not cut, crushed or powdered NS 13 ex Chapter 13 Lac; gums, resins and other vegetable saps and extracts, except for products under subheading 1302 12 00 S 1302 12 00 Vegetable saps and extracts, of liquorice NS S-3 15 1501 90 00 Poultry fat, other than that of headings 0209 or 1503 S 1502 10 90 1502 90 90 Fats of bovine animals, sheep or goats, other than those of heading 1503 and other than for industrial uses other than the manufacture of foodstuffs for human consumption S 1503 00 19 Lard stearin and oleostearin, other than for industrial uses S 1503 00 90 Lard oil, oleo-oil and tallow oil, not emulsified or mixed or otherwise prepared, other than tallow oil for industrial uses other than the manufacture of foodstuffs for human consumption S 1504 Fats and oils and their fractions, of fish or marine mammals, whether or not refined, but not chemically modified S 1505 00 10 Wool grease, crude S 1507 Soya-bean oil and its fractions, whether or not refined, but not chemically modified S 1508 Groundnut oil and its fractions, whether or not refined, but not chemically modified S 1511 10 90 Palm oil, crude, other than for technical or industrial uses other than the manufacture of foodstuffs for human consumption S 1511 90 Palm oil and its fractions, whether or not refined but not chemically modified, other than crude oil S 1512 Sunflower-seed, safflower or cotton-seed oil and fractions thereof, whether or not refined, but not chemically modified S 1513 Coconut (copra), palm-kernel or babassu oil and fractions thereof, whether or not refined, but not chemically modified S 1514 Rape, colza or mustard oil and fractions thereof, whether or not refined, but not chemically modified S 1515 Other fixed vegetable fats and oils (including jojoba oil) and their fractions, whether or not refined, but not chemically modified S ex 1516 Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared, except for products under subheading 1516 20 10 S 1516 20 10 Hydrogenated castor oil, so called \u2018opal-wax\u2019 NS 1517 Margarine; edible mixtures or preparations of animal or vegetable fats or oils or of fractions of different fats or oils of Chapter 15, other than edible fats or oils or their fractions of heading 1516 S 1518 00 Animal or vegetable fats and oils and their fractions, boiled, oxidised, dehydrated, sulphurised, blown, polymerised by heat in vacuum or in inert gas or otherwise chemically modified, excluding those of heading 1516; inedible mixtures or preparations of animal or vegetable fats or oils or of fractions of different fats or oils of Chapter 15, not elsewhere specified or included S 1521 90 99 Beeswax and other insect waxes, whether or not refined or coloured, other than raw S 1522 00 10 Degras S 1522 00 91 Oil foots and dregs; soapstocks, other than containing oil having the characteristics of olive oil S S-4a 16 1601 00 10 Sausages and similar products, of liver, and food preparations based on liver S 1602 20 10 Goose or duck liver, prepared or preserved S 1602 41 90 Ham and cuts thereof, prepared or preserved, of swine other than of domestic swine S 1602 42 90 Shoulders and cuts thereof, prepared or preserved, of swine other than of domestic swine S 1602 49 90 Other prepared or preserved meat or meat offal, including mixtures, of swine other than of domestic swine S 1602 90 31 Other prepared or preserved meat or meat offal, of game or rabbit S 1602 90 69 Other prepared or preserved meat or meat offal, of sheep or goats or other animals, not containing uncooked bovine meat or offal and not containing meat or meat offal of domestic swine S 1602 90 91 1602 90 95 1602 90 99 1602 90 78 1603 00 10 Extracts and juices of meat, fish or crustaceans, molluscs or other aquatic invertebrates, in immediate packings of a net content not exceeding 1 kg S 1604 Prepared or preserved fish; caviar and caviar substitutes prepared from fish eggs S 1605 Crustaceans, molluscs and other aquatic invertebrates, prepared or preserved S S-4b 17 1702 50 00 Chemically pure fructose S 1702 90 10 Chemically pure maltose S 1704 Sugar confectionery (including white chocolate), not containing cocoa S 18 Chapter 18 Cocoa and cocoa preparations S 19 ex Chapter 19 Preparations of cereals, flour, starch or milk; pastrycooks\u2019 products, except for products under subheadings 1901 20 00 and 1901 90 91 S 1901 20 00 Mixes and doughs for the preparation of bakers\u2019 wares of heading 1905 NS 1901 90 91 Other, containing no milkfats, sucrose, isoglucose, glucose or starch or containing less than 1,5 % milk fat, 5 % sucrose (including invert sugar) or isoglucose, 5 % glucose or starch, excluding food preparations in powder form of goods of headings 0401 to 0404 NS 20 ex Chapter 20 Preparations of vegetables, fruit, nuts or other parts of plants, except for products under subheadings 2008 20 19, 2008 20 39, and excluding products under heading 2002 and subheadings 2005 80 00, 2008 40 19, 2008 40 31, 2008 40 51 to 2008 40 90, 2008 70 19, 2008 70 51, 2008 70 61 to 2008 70 98 S 2008 20 19 Pineapples, otherwise prepared or preserved, containing added spirit, not elsewhere specified or included NS 2008 20 39 21 ex Chapter 21 Miscellaneous edible preparations, except for products under subheadings 2101 20 and 2102 20 19, and excluding products under subheadings 2106 10, 2106 90 30, 2106 90 51, 2106 90 55 and 2106 90 59 S 2101 20 Extracts, essences and concentrates, of tea or mat\u00e9, and preparations with a basis of these extracts, essences or concentrates, or with a basis of tea or mat\u00e9 NS 2102 20 19 Other inactive yeasts NS 22 ex Chapter 22 Beverages, spirits and vinegar, excluding products under heading 2207, subheadings 2204 10 11 to 2204 30 10 and subheading 2208 40 S 23 2302 50 00 Residues and wastes of a similar kind, whether or not in the form of pellets, resulting from the grinding or other working of leguminous plants S 2307 00 19 Other wine lees S 2308 00 19 Other grape marc S 2308 00 90 Other vegetable materials and vegetable waste, vegetable residues and by-products, whether or not in the form of pellets, of a kind used in animal feeding, not elsewhere specified or included NS 2309 10 90 Other dog or cat food put up for retail sale, other than containing starch or glucose, glucose syrup, maltodextrine or maltodextrine syrup of subheadings 1702 30 50 to 1702 30 90, 1702 40 90, 1702 90 50 and 2106 90 55 or milk products S 2309 90 10 Fish or marine mammal solubles, of a kind used in animal feeding NS 2309 90 91 Beetpulp with added molasses, of a kind used in animal feeding S 2309 90 96 Other preparations of a kind used in animal feeding, whether or not containing by weight 49 % or more of choline chloride on an organic or inorganic base S S-4c 24 ex Chapter 24 Tobacco and manufactured tobacco substitutes, except for products under subheading 2401 10 60 S 2401 10 60 Sun-cured Oriental type tobacco, unstemmed or unstripped NS S-5 25 2519 90 10 Magnesium oxide, other than calcined natural magnesium carbonate NS 2522 Quicklime, slaked lime and hydraulic lime, other than calcium oxide and hydroxide of heading 2825 NS 2523 Portland cement, aluminous cement, slag cement, supersulphate cement and similar hydraulic cements, whether or not coloured or in the form of clinkers NS 27 Chapter 27 Mineral fuels, mineral oils and products of their distillation; bituminous substances; mineral waxes NS S-6a 28 2801 Fluorine, chlorine, bromine and iodine NS 2802 00 00 Sulphur, sublimed or precipitated; colloidal sulphur NS ex 2804 Hydrogen, rare gases and other non-metals, excluding products under subheading 2804 69 00 NS 2805 19 Alkali or alkaline-earth metals other than sodium and calcium NS 2805 30 Rare-earth metals, scandium and yttrium, whether or not intermixed or interalloyed NS 2806 Hydrogen chloride (hydrochloric acid); chlorosulphuric acid NS 2807 00 Sulphuric acid; oleum NS 2808 00 00 Nitric acid; sulphonitric acids NS 2809 Diphosphorus pentaoxide; phosphoric acid; polyphosphoric acids, whether or not chemically defined NS 2810 00 90 Oxides of boron, other than diboron trioxide; boric acids NS 2811 Other inorganic acids and other inorganic oxygen compounds of non-metals NS 2812 Halides and halide oxides of non-metals NS 2813 Sulphides of non-metals; commercial phosphorus trisulphide NS 2814 Ammonia, anhydrous or in aqueous solution S 2815 Sodium hydroxide (caustic soda); potassium hydroxide (caustic potash); peroxide of sodium or potassium S 2816 Hydroxide and peroxide of magnesium; oxides, hydroxides and peroxides, of strontium or barium NS 2817 00 00 Zinc oxide; zinc peroxide S 2818 10 Artificial corundum, whether or not chemically defined S 2818 20 Aluminium oxide, other than artificial corundum NS 2819 Chromium oxides and hydroxides S 2820 Manganese oxides S 2821 Iron oxides and hydroxides; earth colours containing by weight 70 % or more of combined iron evaluated as Fe2O3 NS 2822 00 00 Cobalt oxides and hydroxides; commercial cobalt oxides NS 2823 00 00 Titanium oxides S 2824 Lead oxides; red lead and orange lead NS ex 2825 Hydrazine and hydroxylamine and their inorganic salts; other inorganic bases; other metal oxides, hydroxides and peroxides, except for products under subheadings 2825 10 00 and 2825 80 00 NS 2825 10 00 Hydrazine and hydroxylamine and their inorganic salts S 2825 80 00 Antimony oxides S 2826 Fluorides; fluorosilicates, fluoroaluminates and other complex fluorine salts NS ex 2827 Chlorides, chloride oxides and chloride hydroxides, except for products under subheadings 2827 10 00 and 2827 32 00; bromides and bromide oxides; iodides and iodide oxides NS 2827 10 00 Ammonium chloride S 2827 32 00 Aluminium chloride S 2828 Hypochlorites; commercial calcium hypochlorite; chlorites; hypobromites NS 2829 Chlorates and perchlorates; bromates and perbromates; iodates and periodates NS ex 2830 Sulphides, except for products under subheading 2830 10 00; polysulphides, whether or not chemically defined NS 2830 10 00 Sodium sulphides S 2831 Dithionites and sulphoxylates NS 2832 Sulphites; thiosulphates NS 2833 Sulphates; alums; peroxosulphates (persulphates) NS 2834 10 00 Nitrites S 2834 21 00 Nitrates NS 2834 29 2835 Phosphinates (hypophosphites), phosphonates (phosphites) and phosphates; polyphosphates, whether or not chemically defined S ex 2836 Carbonates, except for products under subheadings 2836 20 00, 2836 40 00 and 2836 60 00; peroxocarbonates (percarbonates); commercial ammonium carbonate containing ammonium carbamate NS 2836 20 00 Disodium carbonate S 2836 40 00 Potassium carbonates S 2836 60 00 Barium carbonate S 2837 Cyanides, cyanide oxides and complex cyanides NS 2839 Silicates; commercial alkali metal silicates NS 2840 Borates; peroxoborates (perborates) NS ex 2841 Salts of oxometallic or peroxometallic acids, except for the product of subheading 2841 61 00 NS 2841 61 00 Potassium permanganate S 2842 Other salts of inorganic acids or peroxoacids (including aluminosilicates, whether or not chemically defined), other than azides NS 2843 Colloidal precious metals; inorganic or organic compounds of precious metals, whether or not chemically defined; amalgams of precious metals NS ex 2844 30 11 Cermets containing uranium depleted in U-235 or compounds of this product, other than unwrought NS ex 2844 30 51 Cermets containing thorium or compounds of thorium, other than unwrought NS 2845 90 90 Isotopes other than those of heading 2844, and compounds, inorganic or organic, of such isotopes, whether or not chemically defined, other than deuterium and compounds thereof, hydrogen and compounds thereof enriched in deuterium or mixtures and solutions containing these products NS 2846 Compounds, inorganic or organic, of rare-earth metals, of yttrium or of scandium or of mixtures of these metals NS 2847 00 00 Hydrogen peroxide, whether or not solidified with urea NS 2848 00 00 Phosphides, whether or not chemically defined, excluding ferrophosphorus NS ex 2849 Carbides, whether or not chemically defined, except for products under subheadings 2849 20 00 and 2849 90 30 NS 2849 20 00 Silicon carbide, whether or not chemically defined S 2849 90 30 Carbides of tungsten, whether or not chemically defined S ex 2850 00 Hydrides, nitrides, azides and borides, whether or not chemically defined, other than compounds which are also carbides of heading 2849 NS ex 2850 00 60 Silicides, whether or not chemically defined S 2852 00 00 Compounds, inorganic or organic, of mercury, excluding amalgams NS 2853 00 Other inorganic compounds (including distilled or conductivity water and water of similar purity); liquid air (whether or not rare gases have been removed); compressed air; amalgams, other than amalgams of precious metals NS 29 2903 Halogenated derivatives of hydrocarbons S ex 2904 Sulphonated, nitrated or nitrosated derivatives of hydrocarbons, whether or not halogenated, except for products under subheading 2904 20 00 NS 2904 20 00 Derivatives containing only nitro or only nitroso groups S ex 2905 Acyclic alcohols and their halogenated, sulphonated, nitrated or nitrosated derivatives, except for the product of subheading 2905 45 00, and excluding products under subheadings 2905 43 00 and 2905 44 S 2905 45 00 Glycerol NS 2906 Cyclic alcohols and their halogenated, sulphonated, nitrated or nitrosated derivatives NS ex 2907 Phenols, except for products under subheadings 2907 15 90 and ex 2907 22 00; phenol-alcohols NS 2907 15 90 Naphthols and their salts, other than 1-naphthol S ex 2907 22 00 Hydroquinone (quinol) S 2908 Halogenated, sulphonated, nitrated or nitrosated derivatives of phenols or phenol-alcohols NS 2909 Ethers, ether-alcohols, ether-phenols, ether-alcohol-phenols, alcohol peroxides, ether peroxides, ketone peroxides (whether or not chemically defined), and their halogenated, sulphonated, nitrated or nitrosated derivatives S 2910 Epoxides, epoxyalcohols, epoxyphenols and epoxyethers, with a three-membered ring, and their halogenated, sulphonated, nitrated or nitrosated derivatives NS 2911 00 00 Acetals and hemiacetals, whether or not with other oxygen function, and their halogenated, sulphonated, nitrated or nitrosated derivatives NS ex 2912 Aldehydes, whether or not with other oxygen function; cyclic polymers of aldehydes; paraformaldehyde, except for the product of subheading 2912 41 00 NS 2912 41 00 Vanillin (4-hydroxy-3-methoxybenzaldehyde) S 2913 00 00 Halogenated, sulphonated, nitrated or nitrosated derivatives of products under heading 2912 NS ex 2914 Ketones and quinones, whether or not with other oxygen function, and their halogenated, sulphonated, nitrated or nitrosated derivatives, except for products under subheadings 2914 11 00, ex 2914 29 and 2914 22 00 NS 2914 11 00 Acetone S ex 2914 29 Camphor S 2914 22 00 Cyclohexanone and methylcyclohexanones S 2915 Saturated acyclic monocarboxylic acids and their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulphonated, nitrated or nitrosated derivatives S ex 2916 Unsaturated acyclic monocarboxylic acids, cyclic monocarboxylic acids, their anhydrides, halides, peroxides and peroxyacids, and their halogenated, sulphonated, nitrated or nitrosated derivatives, except for products under subheadings ex 2916 11 00, 2916 12 and 2916 14 NS ex 2916 11 00 Acrylic acid S 2916 12 Esters of acrylic acid S 2916 14 Esters of methacrylic acid S ex 2917 Polycarboxylic acids, their anhydrides, halides, peroxides and peroxyacids and their halogenated, sulphonated, nitrated or nitrosated derivatives, except for products under subheadings 2917 11 00, ex 2917 12 00, 2917 14 00, 2917 32 00, 2917 35 00 and 2917 36 00 NS 2917 11 00 Oxalic acid, its salts and esters S ex 2917 12 00 Adipic acid and its salts S 2917 14 00 Maleic anhydride S 2917 32 00 Dioctyl orthophthalates S 2917 35 00 Phthalic anhydride S 2917 36 00 Terephthalic acid and its salts S ex 2918 Carboxylic acids with additional oxygen function and their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulphonated, nitrated or nitrosated derivatives, except for products under subheadings 2918 14 00, 2918 15 00, 2918 21 00, 2918 22 00 and ex 2918 29 00 NS 2918 14 00 Citric acid S 2918 15 00 Salts and esters of citric acid S 2918 21 00 Salicylic acid and its salts S 2918 22 00 o-Acetylsalicylic acid, its salts and esters S ex 2918 29 00 Sulphosalicylic acids, hydroxynaphthoic acids; their salts and esters S 2919 Phosphoric esters and their salts, including lactophosphates; their halogenated, sulphonated, nitrated or nitrosated derivatives NS 2920 Esters of other inorganic acids of non-metals (excluding esters of hydrogen halides) and their salts; their halogenated, sulphonated, nitrated or nitrosated derivatives NS 2921 Amine-function compounds S 2922 Oxygen-function amino-compounds S 2923 Quaternary ammonium salts and hydroxides; lecithins and other phosphoaminolipids, whether or not chemically defined NS ex 2924 Carboxyamide-function compounds and amide-function compounds of carbonic acid, except for products under subheading 2924 23 00 S 2924 23 00 2-Acetamidobenzoic acid (N-acetylanthranilic acid) and its salts NS 2925 Carboxyimide-function compounds (including saccharin and its salts) and imine-function compounds NS ex 2926 Nitrile-function compounds, except for the product of subheading 2926 10 00 NS 2926 10 00 Acrylonitrile S 2927 00 00 Diazo-, azo- or azoxy-compounds S 2928 00 90 Other organic derivatives of hydrazine or of hydroxylamine NS 2929 10 Isocyanates S 2929 90 00 Other compounds with other nitrogen function NS 2930 20 00 Thiocarbamates and dithiocarbamates, and thiuram mono-, di- or tetrasulphides; dithiocarbonates (xanthates) NS 2930 30 00 ex 2930 90 99 2930 40 90 Methionine, captafol (ISO), methamidophos (ISO), and other organo-sulphur compounds other than dithiocarbonates (xanthates) S 2930 50 00 2930 90 13 2930 90 16 2930 90 20 2930 90 60 ex 2930 90 99 2931 00 Other organo-inorganic compounds NS ex 2932 Heterocyclic compounds with oxygen hetero-atom(s) only, except for products under subheadings 2932 12 00, 2932 13 00 and ex 2932 20 90 NS 2932 12 00 2-Furaldehyde (furfuraldehyde) S 2932 13 00 Furfuryl alcohol and tetrahydrofurfuryl alcohol S ex 2932 20 90 Coumarin, methylcoumarins and ethylcoumarins S ex 2933 Heterocylic compounds with nitrogen hetero-atom(s) only, except for the product of subheading 2933 61 00 NS 2933 61 00 Melamine S 2934 Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds NS 2935 00 90 Other sulphonamides S 2938 Glycosides, natural or reproduced by synthesis, and their salts, ethers, esters and other derivatives NS ex 2940 00 00 Sugars, chemically pure, other than sucrose, lactose, maltose, glucose and fructose, and except for rhamnose, raffinose and mannose; sugar ethers, sugar acetals and sugar esters, and their salts, other than products under headings 2937, 2938 or 2939 S ex 2940 00 00 Rhamnose, raffinose and mannose NS 2941 20 30 Dihydrostreptomycin, its salts, esters and hydrates NS 2942 00 00 Other organic compounds NS S-6b 31 3102 21 Ammonium sulphate NS 3102 40 Mixtures of ammonium nitrate with calcium carbonate or other inorganic non-fertilising substances NS 3102 50 Sodium nitrate NS 3102 60 Double salts and mixtures of calcium nitrate and ammonium nitrate NS 3103 10 Superphosphates S 3105 Mineral or chemical fertilisers containing two or three of the fertilising elements nitrogen, phosphorus and potassium; other fertilisers; goods of Chapter 31 in tablets or similar forms or in packages of a gross weight not exceeding 10 kg S 32 ex Chapter 32 Tanning or dyeing extracts; tannins and their derivatives; dyes, pigments and other colouring matter; paints and varnishes; putty and other mastics; inks; except for products under headings 3204 and 3206, and excluding products under subheadings 3201 90 20, ex 3201 90 90 (tanning extracts of eucalyptus), ex 3201 90 90 (tanning extracts derived from gambier and myrobalan fruits) and ex 3201 90 90 (other tanning extracts of vegetable origin) NS 3201 20 00 Wattle extract NS 3204 Synthetic organic colouring matter, whether or not chemically defined; preparations as specified in note 3 to Chapter 32 based on synthetic organic colouring matter; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined S 3206 Other colouring matter; preparations as specified in note 3 to Chapter 32, other than those of headings 3203, 3204 or 3205; inorganic products of a kind used as luminophores, whether or not chemically defined S 33 Chapter 33 Essential oils and resinoids; perfumery, cosmetic or toilet preparations NS 34 Chapter 34 Soap, organic surface-active agents, washing preparations, lubricating preparations, artificial waxes, prepared waxes, polishing or scouring preparations, candles and similar articles, modelling pastes, \u2018dental waxes\u2019 and dental preparations with a basis of plaster NS 35 3501 Casein, caseinates and other casein derivatives; casein glues S 3502 90 90 Albuminates and other albumin derivatives NS 3503 00 Gelatin (including gelatin in rectangular (including square) sheets, whether or not surface-worked or coloured) and gelatin derivatives; isinglass; other glues of animal origin, excluding casein glues of heading 3501 NS 3504 00 00 Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed NS 3505 10 50 Starches, esterified or etherified NS 3506 Prepared glues and other prepared adhesives, not elsewhere specified or included; products suitable for use as glues or adhesives, put up for retail sale as glues or adhesives, not exceeding a net weight of 1 kg NS 3507 Enzymes; prepared enzymes not elsewhere specified or included S 36 Chapter 36 Explosives; pyrotechnic products; matches; pyrophoric alloys; certain combustible preparations NS 37 Chapter 37 Photographic or cinematographic goods NS 38 ex Chapter 38 Miscellaneous chemical products, except for products under headings 3802 and 3817 00, subheadings 3823 12 00 and 3823 70 00, and heading 3825, and excluding the products under subheadings 3809 10 and 3824 60 NS 3802 Activated carbon; activated natural mineral products; animal black, including spent animal black S 3817 00 Mixed alkylbenzenes and mixed alkylnaphthalenes, other than those of headings 2707 or 2902 S 3823 12 00 Oleic acid S 3823 70 00 Industrial fatty alcohols S 3825 Residual products of the chemical or allied industries, not elsewhere specified or included; municipal waste; sewage sludge; other wastes specified in note 6 to Chapter 38 S S-7a 39 ex Chapter 39 Plastics and articles thereof, except for products under headings 3901, 3902, 3903 and 3904, subheadings 3906 10 00, 3907 10 00, 3907 60 and 3907 99, headings 3908 and 3920, and subheadings ex 3921 90 10 and 3923 21 00 NS 3901 Polymers of ethylene, in primary forms S 3902 Polymers of propylene or of other olefins, in primary forms S 3903 Polymers of styrene, in primary forms S 3904 Polymers of vinyl chloride or of other halogenated olefins, in primary forms S 3906 10 00 Poly(methyl methacrylate) S 3907 10 00 Polyacetals S 3907 60 Poly(ethylene terephthalate), except for products of subheading 3907 60 20 S 3907 60 20 Poly(ethylene terephthalate), in primary forms, having a viscosity number of 78 ml/g or higher NS 3907 99 Other polyesters, other than unsaturated S 3908 Polyamides in primary forms S 3920 Other plates, sheets, film, foil and strip, of plastics, non-cellular and not reinforced, laminated, supported or similarly combined with other materials S ex 3921 90 10 Other plates, sheets, film, foil and strip, of polyesters, other than cellular products and other than corrugated sheets and plates S 3923 21 00 Sacks and bags (including cones), of polymers of ethylene S S-7b 40 ex Chapter 40 Rubber and articles thereof, except for products under heading 4010 NS 4010 Conveyor or transmission belts or belting, of vulcanised rubber S S-8a 41 ex 4104 Tanned or crust hides and skins of bovine (including buffalo) or equine animals, without hair on, whether or not split, but not further prepared, excluding the products under subheadings 4104 41 19 and 4104 49 19 S ex 4106 31 00 Tanned or crust hides and skins of swine, without hair on, in the wet state (including wet-blue), split but not further prepared, or in the dry state (crust), whether or not split, but not further prepared NS 4106 32 00 4107 Leather further prepared after tanning or crusting, including parchment-dressed leather, of bovine (including buffalo) or equine animals, without hair on, whether or not split, other than leather of heading 4114 S 4112 00 00 Leather further prepared after tanning or crusting, including parchment-dressed leather, of sheep or lamb, without wool on, whether or not split, other than leather of heading 4114 S ex 4113 Leather further prepared after tanning or crusting, including parchment-dressed leather, of other animals, without wool or hair on, whether or not split, other than leather of heading 4114, except for products under subheading 4113 10 00 NS 4113 10 00 Of goats or kids S 4114 Chamois (including combination chamois) leather; patent leather and patent laminated leather; metallised leather S 4115 10 00 Composition leather with a basis of leather or leather fibre, in slabs, sheets or strip, whether or not in rolls S S-8b 42 ex Chapter 42 Articles of leather; saddlery and harness; travel goods, handbags and similar containers; articles of animal gut (other than silkworm gut); except for products under headings 4202 and 4203 NS 4202 Trunks, suitcases, vanity cases, executive-cases, briefcases, school satchels, spectacle cases, binocular cases, camera cases, musical instrument cases, gun cases, holsters and similar containers; travelling-bags, insulated food or beverages bags, toilet bags, rucksacks, handbags, shopping-bags, wallets, purses, map-cases, cigarette-cases, tobacco-pouches, tool bags, sports bags, bottle-cases, jewellery boxes, powder boxes, cutlery cases and similar containers, of leather or of composition leather, of sheeting of plastics, of textile materials, of vulcanised fibre or of paperboard, or wholly or mainly covered with such materials or with paper S 4203 Articles of apparel and clothing accessories, of leather or of composition leather S 43 Chapter 43 Furskins and artificial fur; manufactures thereof NS S-9a 44 ex Chapter 44 Wood and articles of wood, except for products under headings 4410, 4411, 4412, subheadings 4418 10, 4418 20 10, 4418 71 00, 4420 10 11, 4420 90 10 and 4420 90 91; wood charcoal NS 4410 Particle board, oriented strand board (OSB) and similar board (for example, waferboard) of wood or other ligneous materials, whether or not agglomerated with resins or other organic binding substances S 4411 Fibreboard of wood or other ligneous materials, whether or not bonded with resins or other organic substances S 4412 Plywood, veneered panels and similar laminated wood S 4418 10 Windows, French windows and their frames, of wood S 4418 20 10 Doors and their frames and thresholds, of tropical wood as specified in additional note 2 to Chapter 44 S 4418 71 00 Assembled flooring panels for mosaic floors, of wood S 4420 10 11 Statuettes and other ornaments, of tropical wood as specified in additional note 2 to Chapter 44; wood marquetry and inlaid wood; caskets and cases for jewellery or cutlery, and similar articles, and wooden articles of furniture not falling in Chapter 94, of tropical wood as specified in additional note 2 to Chapter 44 S 4420 90 10 4420 90 91 S-9b 45 ex Chapter 45 Cork and articles of cork, except for products under heading 4503 NS 4503 Articles of natural cork S 46 Chapter 46 Manufactures of straw, of esparto or of other plaiting materials; basketware and wickerwork S S-11a 50 Chapter 50 Silk S 51 ex Chapter 51 Wool, fine or coarse animal hair, excluding the products under heading 5105; horsehair yarn and woven fabric S 52 Chapter 52 Cotton S 53 Chapter 53 Other vegetable textile fibres; paper yarn and woven fabrics of paper yarn S 54 Chapter 54 Man-made filaments; strip and the like of man-made textile materials S 55 Chapter 55 Man-made staple fibres S 56 Chapter 56 Wadding, felt and non-wovens; special yarns; twine, cordage, ropes and cables and articles thereof S 57 Chapter 57 Carpets and other textile floor coverings S 58 Chapter 58 Special woven fabrics; tufted textile fabrics; lace; tapestries; trimmings; embroidery S 59 Chapter 59 Impregnated, coated, covered or laminated textile fabrics; textile articles of a kind suitable for industrial use S 60 Chapter 60 Knitted or crocheted fabrics S S-11b 61 Chapter 61 Articles of apparel and clothing accessories, knitted or crocheted S 62 Chapter 62 Articles of apparel and clothing accessories, not knitted or crocheted S 63 Chapter 63 Other made-up textile articles; sets; worn clothing and worn textile articles; rags S S-12a 64 Chapter 64 Footwear, gaiters and the like; parts of such articles S S-12b 65 Chapter 65 Headgear and parts thereof NS 66 Chapter 66 Umbrellas, sun umbrellas, walking sticks, seat-sticks, whips, riding-crops and parts thereof S 67 Chapter 67 Prepared feathers and down and articles made of feathers or of down; artificial flowers; articles of human hair NS S-13 68 Chapter 68 Articles of stone, plaster, cement, asbestos, mica or similar materials NS 69 Chapter 69 Ceramic products S 70 Chapter 70 Glass and glassware S S-14 71 ex Chapter 71 Natural or cultured pearls, precious or semi-precious stones, precious metals, metals clad with precious metal, and articles thereof; imitation jewellery; coin; except for products under heading 7117 NS 7117 Imitation jewellery S S-15a 72 7202 Ferro-alloys S 73 Chapter 73 Articles of iron or steel NS S-15b 74 Chapter 74 Copper and articles thereof S 75 7505 12 00 Bars, rods and profiles, of nickel alloys NS 7505 22 00 Wire, of nickel alloys NS 7506 20 00 Plates, sheets, strip and foil, of nickel alloys NS 7507 20 00 Nickel tube or pipe fittings NS 76 ex Chapter 76 Aluminium and articles thereof, excluding the products under heading 7601 S 78 ex Chapter 78 Lead and articles thereof, excluding the products under heading 7801 S 7801 99 Unwrought lead other than refined and other than containing by weight antimony as the principal other element NS 79 ex Chapter 79 Zinc and articles thereof, excluding the products under headings 7901 and 7903 S 81 ex Chapter 81 Other base metals; cermets; articles thereof, excluding the products under subheadings 8101 10 00, 8102 10 00, 8102 94 00, 8109 20 00, 8110 10 00, 8112 21 90, 8112 51 00, 8112 59 00, 8112 92 and 8113 00 20, except for products under subheadings 8101 94 00, 8104 11 00, 8104 19 00, 8107 20 00, 8108 20 00 and 8108 30 00 S 8101 94 00 Unwrought tungsten (wolfram), including bars and rods obtained simply by sintering NS 8104 11 00 Unwrought magnesium, containing at least 99,8 % by weight of magnesium NS 8104 19 00 Unwrought magnesium other than of subheading 8104 11 00 NS 8107 20 00 Unwrought cadmium; powders NS 8108 20 00 Unwrought titanium; powders NS 8108 30 00 Titanium waste and scrap NS 82 Chapter 82 Tools, implements, cutlery, spoons and forks, of base metal; parts thereof, of base metal S 83 Chapter 83 Miscellaneous articles of base metal S S-16 84 ex Chapter 84 Nuclear reactors, boilers, machinery and mechanical appliances, and parts thereof, except for products under subheadings 8401 10 00 and 8407 21 10 NS 8401 10 00 Nuclear reactors S 8407 21 10 Outboard motors, of a cylinder capacity not exceeding 325 cm3 S 85 ex Chapter 85 Electrical machinery and equipment and parts thereof; sound recorders and reproducers, television image and sound recorders and reproducers, and parts and accessories of such articles, except for products under subheadings 8516 50 00, 8517 69 39, 8517 70 15, 8517 70 19, 8519 20, 8519 30, 8519 81 11 to 8519 81 45, 8519 81 85, 8519 89 11 to 8519 89 19, headings 8521, 8525 and 8527, subheadings 8528 49, 8528 59 and 8528 69 to 8528 72, heading 8529 and subheadings 8540 11 and 8540 12 NS 8516 50 00 Microwave ovens S 8517 69 39 Reception apparatus for radio-telephony or radio telegraphy, other than portable receivers for calling, alerting or paging S 8517 70 15 Aerials and aerial reflectors of all kinds, other than aerials for radio-telegraphic or radio-telephonic apparatus; parts suitable for use therewith S 8517 70 19 8519 20 Apparatus operated by coins, banknotes, bank cards, tokens or by other means of payment; turntables (record-decks) S 8519 30 8519 81 11 to 8519 81 45 Sound-reproducing apparatus (including cassette-players), not incorporating a sound-recording device S 8519 81 85 Other magnetic tape recorders incorporating sound-reproducing apparatus, other than cassette-type S 8519 89 11 to 8519 89 19 Other sound-reproducing apparatus, not incorporating a sound-recording device S ex 8521 Video recording or reproducing apparatus, whether or not incorporating a video tuner, except products of subheading 8521 90 00 S 8521 90 00 Video recording or reproducing apparatus (excluding magnetic tape-type); video recording or reproducing apparatus, whether or not incorporating a video tuner (excluding magnetic tape-type and video camera recorders) NS 8525 Transmission apparatus for radio-broadcasting or television, whether or not incorporating reception apparatus or sound-recording or -reproducing apparatus; television cameras; digital cameras and video camera recorders S 8527 Reception apparatus for radio-broadcasting, whether or not combined, in the same housing, with sound-recording or -reproducing apparatus or a clock S 8528 49 Monitors and projectors, not incorporating television-reception apparatus, other than of a kind used solely or principally in an automatic data-processing system of heading 8471; reception apparatus for television, whether or not incorporating radio-broadcast receivers or sound- or video-recording or -reproducing apparatus S 8528 59 8528 69 to 8528 72 8529 Parts suitable for use solely or principally with the apparatus of headings 8525 to 8528 S 8540 11 Cathode ray television picture tubes, including video monitor cathode ray tubes, colour, or black-and-white or other monochrome S 8540 12 00 S-17a 86 Chapter 86 Railway or tramway locomotives, rolling stock and parts thereof; railway or tramway track fixtures and fittings and parts thereof; mechanical (including electromechanical) traffic-signalling equipment of all kinds NS S-17b 87 ex Chapter 87 Vehicles other than railway or tramway rolling stock, and parts and accessories thereof, except for products under headings 8702, 8703, 8704, 8705, 8706 00, 8707, 8708, 8709, 8711, 8712 00 and 8714 NS 8702 Motor vehicles for the transport of ten or more persons, including the driver S 8703 Motor cars and other motor vehicles principally designed for the transport of persons (other than those of heading 8702), including station wagons and racing cars S 8704 Motor vehicles for the transport of goods S 8705 Special-purpose motor vehicles, other than those principally designed for the transport of persons or goods (for example, breakdown lorries, crane lorries, fire-fighting vehicles, concrete-mixer lorries, road-sweeper lorries, spraying lorries, mobile workshops, mobile radiological units) S 8706 00 Chassis fitted with engines, for the motor vehicles of headings 8701 to 8705 S 8707 Bodies (including cabs), for the motor vehicles of headings 8701 to 8705 S 8708 Parts and accessories of the motor vehicles of headings 8701 to 8705 S 8709 Works trucks, self-propelled, not fitted with lifting or handling equipment, of the type used in factories, warehouses, dock areas or airports for short-distance transport of goods; tractors of the type used on railway-station platforms; parts of the foregoing vehicles S 8711 Motorcycles (including mopeds) and cycles fitted with an auxiliary motor, with or without sidecars; sidecars S 8712 00 Bicycles and other cycles (including delivery tricycles), not motorised S 8714 Parts and accessories of vehicles of headings 8711 to 8713 S 88 Chapter 88 Aircraft, spacecraft, and parts thereof NS 89 Chapter 89 Ships, boats and floating structures NS S-18 90 Chapter 90 Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus; parts and accessories thereof S 91 Chapter 91 Clocks and watches and parts thereof S 92 Chapter 92 Musical instruments; parts and accessories of such articles NS S-20 94 ex Chapter 94 Furniture; bedding, mattresses, mattress supports, cushions and similar stuffed furnishings; lamps and lighting fittings, not elsewhere specified or included; illuminated signs, illuminated nameplates and the like; prefabricated buildings, except for products under heading 9405 NS 9405 Lamps and lighting fittings including searchlights and spotlights and parts thereof, not elsewhere specified or included; illuminated signs, illuminated nameplates and the like, having a permanently fixed light source, and parts thereof not elsewhere specified or included S 95 ex Chapter 95 Toys, games and sports requisites; parts and accessories thereof; except for products under subheadings 9503 00 35 to 9503 00 99 NS 9503 00 35 to 9503 00 99 Other toys; reduced-size (\u2018scale\u2019) models and similar recreational models, working or not; puzzles of all kinds S 96 Chapter 96 Miscellaneous manufactured articles NS ANNEX VI Modalities for the application of Article 8 1. Article 8 shall apply when the percentage share referred to in paragraph 1 of that Article exceeds 17,5 %. 2. Article 8 shall apply for each of the GSP sections S-11a and S-11b of Annex V, when the percentage share referred to in paragraph 1 of that Article exceeds 14,5 %. ANNEX VII Modalities for the application of Chapter III of this Regulation 1. For the purposes of Chapter III a vulnerable country means a country: (a) of which, in terms of value, the seven largest GSP sections of its imports into the Union of products listed in Annex IX represent more than the threshold of 75 % in value of its total imports of products listed in that Annex, as an average during the last three consecutive years; and (b) of which the imports of products listed in Annex IX into the Union represent less than the threshold of 2 % in value of the total imports into the Union of products listed in that Annex originating in countries listed in Annex II, as an average during the last three consecutive years. 2. For the purposes of point (a) of Article 9(1), the data to be used in application of point 1 of this Annex are those available on 1 September of the year preceding the year of the request referred to in Article 10(1). 3. For the purposes of Article 11, the data to be used in application of point 1 of this Annex are those available on 1 September of the year preceding the year when the delegated act referred to in Article 11(2) is adopted. ANNEX VIII Conventions referred to in Article 9 PART A Core human and labour rights UN/ILO Conventions 1. Convention on the Prevention and Punishment of the Crime of Genocide (1948) 2. International Convention on the Elimination of All Forms of Racial Discrimination (1965) 3. International Covenant on Civil and Political Rights (1966) 4. International Covenant on Economic Social and Cultural Rights (1966) 5. Convention on the Elimination of All Forms of Discrimination Against Women (1979) 6. Convention Against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment (1984) 7. Convention on the Rights of the Child (1989) 8. Convention concerning Forced or Compulsory Labour, No 29 (1930) 9. Convention concerning Freedom of Association and Protection of the Right to Organise, No 87 (1948) 10. Convention concerning the Application of the Principles of the Right to Organise and to Bargain Collectively, No 98 (1949) 11. Convention concerning Equal Remuneration of Men and Women Workers for Work of Equal Value, No 100 (1951) 12. Convention concerning the Abolition of Forced Labour, No 105 (1957) 13. Convention concerning Discrimination in Respect of Employment and Occupation, No 111 (1958) 14. Convention concerning Minimum Age for Admission to Employment, No 138 (1973) 15. Convention concerning the Prohibition and Immediate Action for the Elimination of the Worst Forms of Child Labour, No 182 (1999) PART B Conventions related to the environment and to governance principles 16. Convention on International Trade in Endangered Species of Wild Fauna and Flora (1973) 17. Montreal Protocol on Substances that Deplete the Ozone Layer (1987) 18. Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal (1989) 19. Convention on Biological Diversity (1992) 20. The United Nations Framework Convention on Climate Change (1992) 21. Cartagena Protocol on Biosafety (2000) 22. Stockholm Convention on persistent Organic Pollutants (2001) 23. Kyoto Protocol to the United Nations Framework Convention on Climate Change (1998) 24. United Nations Single Convention on Narcotic Drugs (1961) 25. United Nations Convention on Psychotropic Substances (1971) 26. United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988) 27. United Nations Convention against Corruption (2004) ANNEX IX List of products included in the special incentive arrangement for sustainable development and good governance referred to in point (b) of Article 1(2) Notwithstanding the rules for the interpretation of the Combined Nomenclature, the description of the products is to be considered as indicative, the tariff preferences being determined by the CN codes. Where \u2018ex\u2019 CN codes are indicated, the tariff preferences are to be determined by the CN code and the description, together. Entry of products with a CN code marked with an asterisk (*) is subject to the conditions laid down in the relevant Union law. The column \u2018Section\u2019 lists GSP sections (Article 2(h)) The column \u2018Chapter\u2019 lists CN chapters covered by a GSP section (Article 2(i)) For reasons of simplification, the products are listed in groups. These may include products for which Common Customs Tariff duties were withdrawn or suspended. Section Chapter CN code Description S-1a 01 0101 29 90 Live horses, other than pure-bred breeding animals, other than for slaughter 0101 30 00 Live asses 0101 90 00 Live mules and hinnies 0104 20 10* Live, pure-bred breeding goats 0106 14 10 Live domestic rabbits 0106 39 10 Live pigeons 02 0205 00 Meat of horses, asses, mules or hinnies, fresh, chilled or frozen 0206 80 91 Edible offal of horses, asses, mules or hinnies, fresh or chilled, other than for the manufacture of pharmaceutical products 0206 90 91 Edible offal of horses, asses, mules or hinnies, frozen, other than for the manufacture of pharmaceutical products 0207 14 91 Livers, frozen, of fowls of the species Gallus domesticus 0207 27 91 Livers, frozen, of turkeys 0207 45 95 0207 55 95 0207 60 91 Livers, frozen, of ducks, geese or guinea fowls, other than fatty livers of ducks or geese ex 0208 Other meat and edible meat offal, fresh, chilled or frozen, excluding products under subheading 0208 40 20 0210 99 10 Meat of horses, salted, in brine or dried 0210 99 59 Offal of bovine animals, salted, in brine, dried or smoked, other than thick skirt and thin skirt ex 0210 99 85 Offal of sheep or goats, salted, in brine, dried or smoked ex 0210 99 85 Offal, salted, in brine, dried or smoked, other than poultry liver, other than of domestic swine, of bovine animals or of sheep or goats 04 0403 10 51 Yogurt, flavoured or containing added fruit, nuts or cocoa 0403 10 53 0403 10 59 0403 10 91 0403 10 93 0403 10 99 0403 90 71 Buttermilk, curdled milk and cream, kephir and other fermented or acidified milk and cream, flavoured or containing added fruit, nuts or cocoa 0403 90 73 0403 90 79 0403 90 91 0403 90 93 0403 90 99 0405 20 10 Dairy spreads, of a fat content, by weight, of 39 % or more but not exceeding 75 % 0405 20 30 0407 19 90 0407 29 90 0407 90 90 Birds\u2019 eggs, in shell, fresh, preserved or cooked, other than of poultry 0409 00 00 Natural honey 0410 00 00 Edible products of animal origin, not elsewhere specified or included 05 0511 99 39 Natural sponges of animal origin, other than raw S-1b 03 Chapter 3 (1) Fish and crustaceans, molluscs and other aquatic invertebrates S-2a 06 Chapter 6 Live trees and other plants; bulbs, roots and the like; cut flowers and ornamental foliage S-2b 07 0701 Potatoes, fresh or chilled 0703 10 Onions and shallots, fresh or chilled 0703 90 00 Leeks and other alliaceous vegetables, fresh or chilled 0704 Cabbages, cauliflowers, kohlrabi, kale and similar edible brassicas, fresh or chilled 0705 Lettuce (Lactuca sativa) and chicory (Cichorium spp.), fresh or chilled 0706 Carrots, turnips, salad beetroot, salsify, celeriac, radishes and similar edible roots, fresh or chilled ex 0707 00 05 Cucumbers, fresh or chilled, from 16 May to 31 October 0708 Leguminous vegetables, shelled or unshelled, fresh or chilled 0709 20 00 Asparagus, fresh or chilled 0709 30 00 Aubergines (eggplants), fresh or chilled 0709 40 00 Celery other than celeriac, fresh or chilled 0709 51 00 Mushrooms, fresh or chilled, excluding the products under subheading 0709 59 50 ex 0709 59 0709 60 10 Sweet peppers, fresh or chilled 0709 60 99 Fruits of the genus Capsicum or of the genus Pimenta, fresh or chilled, other than sweet peppers, other than for the manufacture of capsaicin or capsicum oleoresin dyes and other than for the industrial manufacture of essential oils or resinoids 0709 70 00 Spinach, New Zealand spinach and orache spinach (garden spinach), fresh or chilled 0709 92 10* Olives, fresh or chilled, for uses other than the production of oil 0709 99 10 Salad vegetables, fresh or chilled, other than lettuce (Lactuca sativa) and chicory (Cichorium spp.) 0709 99 20 Chard (or white beet) and cardoons, fresh or chilled 0709 93 10 Courgettes, fresh or chilled 0709 99 40 Capers, fresh or chilled 0709 99 50 Fennel, fresh or chilled ex 0709 91 00 Globe artichokes, fresh or chilled, from 1 July to 31 October 0709 93 90 0709 99 90 Other vegetables, fresh or chilled 0710 Vegetables (uncooked or cooked by steaming or boiling in water), frozen ex 0711 Vegetables provisionally preserved (for example, by sulphur dioxide gas, in brine, in sulphur water or in other preservative solutions), but unsuitable in that state for immediate consumption, excluding the products under subheading 0711 20 90 ex 0712 Dried vegetables, whole, cut, sliced, broken or in powder, but not further prepared, excluding olives and the products under subheading 0712 90 19 0713 Dried leguminous vegetables, shelled, whether or not skinned or split 0714 20 10* Sweet potatoes, fresh, whole, and intended for human consumption 0714 20 90 Sweet potatoes, fresh, chilled, frozen or dried, whether or not sliced or in the form of pellets, other than fresh and whole and intended for human consumption 0714 90 90 Jerusalem artichokes and similar roots and tubers with high inulin content, fresh, chilled, frozen or dried, whether or not sliced or in the form of pellets; sago pith 08 0802 11 90 Almonds, fresh or dried, whether or not shelled, other than bitter 0802 12 90 0802 21 00 Hazelnuts or filberts (Corylus spp.), fresh or dried, whether or not shelled 0802 22 00 0802 31 00 Walnuts, fresh or dried, whether or not shelled 0802 32 00 0802 41 00 0802 42 00 Chestnuts (Castanea spp.), fresh or dried, whether or not shelled or peeled 0802 51 00 0802 52 00 Pistachios, fresh or dried, whether or not shelled or peeled 0802 61 00 0802 62 00 Macadamia nuts, fresh or dried, whether or not shelled or peeled 0802 90 50 Pine nuts, fresh or dried, whether or not shelled or peeled 0802 90 85 Other nuts, fresh or dried, whether or not shelled or peeled 0803 10 10 Plantains, fresh 0803 10 90 0803 90 90 Bananas, including plantains, dried 0804 10 00 Dates, fresh or dried 0804 20 10 Figs, fresh or dried 0804 20 90 0804 30 00 Pineapples, fresh or dried 0804 40 00 Avocados, fresh or dried ex 0805 20 Mandarins (including tangerines and satsumas), and clementines, wilkings and similar citrus hybrids, fresh or dried, from 1 March to 31 October 0805 40 00 Grapefruit, including pomelos, fresh or dried 0805 50 90 Limes (Citrus aurantifolia, Citrus latifolia), fresh or dried 0805 90 00 Other citrus fruit, fresh or dried ex 0806 10 10 Table grapes, fresh, from 1 January to 20 July and from 21 November to 31 December, excluding grapes of the variety Emperor (Vitis vinifera cv.) from 1 to 31 December 0806 10 90 Other grapes, fresh ex 0806 20 Dried grapes, excluding products under subheading ex 0806 20 30 in immediate containers of a net capacity exceeding 2 kg 0807 11 00 Melons (including watermelons), fresh 0807 19 00 0808 10 10 Cider apples, fresh, in bulk, from 16 September to 15 December 0808 30 10 Perry pears, fresh, in bulk, from 1 August to 31 December ex 0808 30 90 Other pears, fresh, from 1 May to 30 June 0808 40 00 Quinces, fresh ex 0809 10 00 Apricots, fresh, from 1 January to 31 May and from 1 August to 31 December 0809 21 00 Sour cherries (Prunus cerasus), fresh ex 0809 29 Cherries, fresh, from 1 January to 20 May and from 11 August to 31 December, other than sour cherries (Prunus cerasus) ex 0809 30 Peaches, including nectarines, fresh, from 1 January to 10 June and from 1 October to 31 December ex 0809 40 05 Plums, fresh, from 1 January to 10 June and from 1 October to 31 December 0809 40 90 Sloes, fresh ex 0810 10 00 Strawberries, fresh, from 1 January to 30 April and from 1 August to 31 December 0810 20 Raspberries, blackberries, mulberries and loganberries, fresh 0810 30 00 Black-, white- or redcurrants and groseberries, fresh 0810 40 30 Fruit of the species Vaccinium myrtillus, fresh 0810 40 50 Fruit of the species Vaccinium macrocarpon and Vaccinium corymbosum, fresh 0810 40 90 Other fruits of the genus Vaccinium, fresh 0810 50 00 Kiwifruit, fresh 0810 60 00 Durians, fresh 0810 70 00 Persimmons 0810 90 75 Other fruit, fresh 0811 Fruit and nuts, uncooked or cooked by steaming or boiling in water, frozen, whether or not containing added sugar or other sweetening matter, 0812 Fruit and nuts, provisionally preserved (for example, by sulphur dioxide gas, in brine, in sulphur water or in other preservative solutions), but unsuitable in that state for immediate consumption 0813 10 00 Apricots, dried 0813 20 00 Prunes 0813 30 00 Apples, dried 0813 40 10 Peaches, including nectarines, dried 0813 40 30 Pears, dried 0813 40 50 Papaws (papayas), dried 0813 40 95 Other fruit, dried, other than that of headings 0801 to 0806 0813 50 12 Mixtures of dried fruit (other than that of headings 0801 to 0806) of papaws (papayas), tamarinds, cashew apples, lychees, jackfruit, sapodilla plums, passion fruit, carambola or pitahaya, but not containing prunes 0813 50 15 Other mixtures of dried fruit (other than that of headings 0801 to 0806), not containing prunes 0813 50 19 Mixtures of dried fruit (other than that of headings 0801 to 0806), containing prunes 0813 50 31 Mixtures exclusively of tropical nuts of headings 0801 and 0802 0813 50 39 Mixtures exclusively of nuts of headings 0801 and 0802, other than of tropical nuts 0813 50 91 Other mixtures of nuts and dried fruits of Chapter 8, not containing prunes or figs 0813 50 99 Other mixtures of nuts and dried fruits of Chapter 8 0814 00 00 Peel of citrus fruit or melons (including watermelons), fresh, frozen, dried or provisionally preserved in brine, in sulphur water or in other preservative solutions S-2c 09 Chapter 9 Coffee, tea, mat\u00e9 and spices S-2d 10 1008 50 00 Quinoa (Chenopodium quinoa) 11 1104 29 17 Hulled cereal grains excluding barley, oats, maize, rice and wheat. 1105 Flour, meal, powder, flakes, granules and pellets of potatoes 1106 10 00 Flour, meal and powder of the dried leguminous vegetables of heading 0713 1106 30 Flour, meal and powder of products from Chapter 8 1108 20 00 Inulin 12 ex Chapter 12 Oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruit, industrial or medicinal plants; straw and fodder excluding products under heading 1210 and subheadings 1212 91 and 1212 93 00 13 Chapter 13 Lac; gums, resins and other vegetable saps and extracts S-3 15 1501 90 00 Poultry fat, other than that of heading 0209 or 1503 1502 10 90 1502 90 90 Fats of bovine animals, sheep or goats, other than those of heading 1503 and other than for industrial uses other than the manufacture of foodstuffs for human consumption 1503 00 19 Lard stearin and oleostearin, other than for industrial uses 1503 00 90 Lard oil, oleo-oil and tallow oil, not emulsified or mixed or otherwise prepared, other than tallow oil for industrial uses other than the manufacture of foodstuffs for human consumption 1504 Fats and oils and their fractions, of fish or marine mammals, whether or not refined, but not chemically modified 1505 00 10 Wool grease, crude 1507 Soya-bean oil and its fractions, whether or not refined, but not chemically modified 1508 Groundnut oil and its fractions, whether or not refined, but not chemically modified 1511 10 90 Palm oil, crude, other than for technical or industrial uses other than the manufacture of foodstuffs for human consumption 1511 90 Palm oil and its fractions, whether or not refined but not chemically modified, other than crude oil 1512 Sunflower-seed, safflower or cotton-seed oil and fractions thereof, whether or not refined, but not chemically modified 1513 Coconut (copra), palm-kernel or babassu oil and fractions thereof, whether or not refined, but not chemically modified 1514 Rape, colza or mustard oil and fractions thereof, whether or not refined, but not chemically modified 1515 Other fixed vegetable fats and oils (including jojoba oil) and their fractions, whether or not refined, but not chemically modified 1516 Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared 1517 Margarine; edible mixtures or preparations of animal or vegetable fats or oils or of fractions of different fats or oils of Chapter 15, other than edible fats or oils or their fractions of heading 1516 1518 00 Animal or vegetable fats and oils and their fractions, boiled, oxidised, dehydrated, sulphurised, blown, polymerised by heat in vacuum or in inert gas or otherwise chemically modified, excluding those of heading 1516; inedible mixtures or preparations of animal or vegetable fats or oils or of fractions of different fats or oils of Chapter 15, not elsewhere specified or included 1521 90 99 Beeswax and other insect waxes, whether or not refined or coloured, other than raw 1522 00 10 Degras 1522 00 91 Oil foots and dregs; soapstocks, other than containing oil having the characteristics of olive oil S-4a 16 1601 00 10 Sausages and similar products, of liver, and food preparations based on liver 1602 20 10 Goose or duck liver, prepared or preserved 1602 41 90 Ham and cuts thereof, prepared or preserved, of swine other than of domestic swine 1602 42 90 Shoulders and cuts thereof, prepared or preserved, of swine other than of domestic swine 1602 49 90 Other prepared or preserved meat or meat offal, including mixtures, of swine other than of domestic swine 1602 50 31 1602 50 95 Other prepared or preserved meat or meat offal, cooked, of bovine animals, whether or not in airtight containers 1602 90 31 Other prepared or preserved meat or meat offal, of game or rabbit 1602 90 69 Other prepared or preserved meat or meat offal, of sheep or goats or other animals, not containing uncooked bovine meat or offal and not containing meat or meat offal of domestic swine 1602 90 91 1602 90 95 1602 90 99 1602 90 78 1603 00 10 Extracts and juices of meat, fish or crustaceans, molluscs or other aquatic invertebrates, in immediate packings of a net content not exceeding 1 kg 1604 Prepared or preserved fish; caviar and caviar substitutes prepared from fish eggs 1605 Crustaceans, molluscs and other aquatic invertebrates, prepared or preserved S-4b 17 1702 50 00 Chemically pure fructose 1702 90 10 Chemically pure maltose 1704 (2) Sugar confectionery (including white chocolate), not containing cocoa 18 Chapter 18 Cocoa and cocoa preparations 19 Chapter 19 Preparations of cereals, flour, starch or milk; pastrycooks\u2019 products 20 Chapter 20 Preparations of vegetables, fruit, nuts or other parts of plants 21 ex Chapter 21 Miscellaneous edible preparations excluding products under subheadings 2106 10, 2106 90 30, 2106 90 51, 2106 90 55 and 2106 90 59 22 ex Chapter 22 Beverages, spirits and vinegar excluding products under subheadings 2204 10 11 to 2204 30 10 and subheading 2208 40 23 2302 50 00 Residues and wastes of a similar kind, whether or not in the form of pellets, resulting from the grinding or other working of leguminous plants 2307 00 19 Other wine lees 2308 00 19 Other grape marc 2308 00 90 Other vegetable materials and vegetable waste, vegetable residues and by-products, whether or not in the form of pellets, of a kind used in animal feeding, not elsewhere specified or included 2309 10 90 Other dog or cat food put up for retail sale, other than containing starch or glucose, glucose syrup, maltodextrine or maltodextrine syrup of subheadings 1702 30 50 to 1702 30 90, 1702 40 90, 1702 90 50 and 2106 90 55 or milk products 2309 90 10 Fish or marine mammal solubles, of a kind used in animal feeding 2309 90 91 Beetpulp with added molasses, of a kind used in animal feeding 2309 90 96 Other preparations of a kind used in animal feeding, whether or not containing by weight 49 % or more of choline chloride on an organic or inorganic base S-4c 24 Chapter 24 Tobacco and manufactured tobacco substitutes S-5 25 2519 90 10 Magnesium oxide, other than calcined natural magnesium carbonate 2522 Quicklime, slaked lime and hydraulic lime, other than calcium oxide and hydroxide of heading 2825 2523 Portland cement, aluminous cement, slag cement, supersulphate cement and similar hydraulic cements, whether or not coloured or in the form of clinkers 27 Chapter 27 Mineral fuels, mineral oils and products of their distillation; bituminous substances; mineral waxes S-6a 28 2801 Fluorine, chlorine, bromine and iodine 2802 00 00 Sulphur, sublimed or precipitated; colloidal sulphur ex 2804 Hydrogen, rare gases and other non-metals, excluding products under subheading 2804 69 00 2805 19 Alkali or alkaline-earth metals other than sodium and calcium 2805 30 Rare-earth metals, scandium and yttrium, whether or not intermixed or interalloyed 2806 Hydrogen chloride (hydrochloric acid); chlorosulphuric acid 2807 00 Sulphuric acid; oleum 2808 00 00 Nitric acid; sulphonitric acids 2809 Diphosphorus pentaoxide; phosphoric acid; polyphosphoric acids, whether or not chemically defined 2810 00 90 Oxides of boron, other than diboron trioxide; boric acids 2811 Other inorganic acids and other inorganic oxygen compounds of non-metals 2812 Halides and halide oxides of non-metals 2813 Sulphides of non-metals; commercial phosphorus trisulphide 2814 Ammonia, anhydrous or in aqueous solution 2815 Sodium hydroxide (caustic soda); potassium hydroxide (caustic potash); peroxide of sodium or potassium 2816 Hydroxide and peroxide of magnesium; oxides, hydroxides and peroxides, of strontium or barium 2817 00 00 Zinc oxide; zinc peroxide 2818 10 Artificial corundum, whether or not chemically defined 2818 20 Aluminium oxide other than artificial corundum 2819 Chromium oxides and hydroxides 2820 Manganese oxides 2821 Iron oxides and hydroxides; earth colours containing by weight 70 % or more of combined iron evaluated as Fe2O3 2822 00 00 Cobalt oxides and hydroxides; commercial cobalt oxides 2823 00 00 Titanium oxides 2824 Lead oxides; red lead and orange lead 2825 Hydrazine and hydroxylamine and their inorganic salts; other inorganic bases; other metal oxides, hydroxides and peroxides 2826 Fluorides; fluorosilicates, fluoroaluminates and other complex fluorine salts 2827 Chlorides, chloride oxides and chloride hydroxides bromides and bromide oxides; iodides and iodide oxides 2828 Hypochlorites; commercial calcium hypochlorite; chlorites; hypobromites 2829 Chlorates and perchlorates; bromates and perbromates; iodates and periodates 2830 Sulphides; polysulphides, whether or not chemically defined 2831 Dithionites and sulphoxylates 2832 Sulphites; thiosulphates 2833 Sulphates; alums; peroxosulphates (persulphates) 2834 10 00 Nitrites 2834 21 00 Nitrates 2834 29 2835 Phosphinates (hypophosphites), phosphonates (phosphites) and phosphates; polyphosphates, whether or not chemically defined 2836 Carbonates; peroxocarbonates (percarbonates); commercial ammonium carbonate containing ammonium carbamate 2837 Cyanides, cyanide oxides and complex cyanides 2839 Silicates; commercial alkali metal silicates 2840 Borates; peroxoborates (perborates) 2841 Salts of oxometallic or peroxometallic acids, 2842 Other salts of inorganic acids or peroxoacids (including aluminosilicates, whether or not chemically defined), other than azides 2843 Colloidal precious metals; inorganic or organic compounds of precious metals, whether or not chemically defined; amalgams of precious metals ex 2844 30 11 Cermets containing uranium depleted in U-235 or compounds of this product, other than unwrought ex 2844 30 51 Cermets containing thorium or compounds of thorium, other than unwrought 2845 90 90 Isotopes other than those of heading 2844, and compounds, inorganic or organic, of such isotopes, whether or not chemically defined, other than deuterium and compounds thereof, hydrogen and compounds thereof enriched in deuterium or mixtures and solutions containing these products 2846 Compounds, inorganic or organic, of rare-earth metals, of yttrium or of scandium or of mixtures of these metals 2847 00 00 Hydrogen peroxide, whether or not solidified with urea 2848 00 00 Phosphides, whether or not chemically defined, excluding ferrophosphorus 2849 Carbides, whether or not chemically defined 2850 00 Hydrides, nitrides, azides, silicides and borides, whether or not chemically defined, other than compounds which are also carbides of heading 2849 2852 00 00 Compounds, inorganic or organic, of mercury, excluding amalgams 2853 00 Other inorganic compounds (including distilled or conductivity water and water of similar purity); liquid air (whether or not rare gases have been removed); compressed air; amalgams, other than amalgams of precious metals 29 2903 Halogenated derivatives of hydrocarbons 2904 Sulphonated, nitrated or nitrosated derivatives of hydrocarbons, whether or not halogenated ex 2905 Acyclic alcohols and their halogenated, sulphonated, nitrated or nitrosated derivatives, excluding products under subheadings 2905 43 00 and 2905 44 2906 Cyclic alcohols and their halogenated, sulphonated, nitrated or nitrosated derivatives 2907 Phenols; phenol-alcohols 2908 Halogenated, sulphonated, nitrated or nitrosated derivatives of phenols or phenol-alcohols 2909 Ethers, ether-alcohols, ether-phenols, ether-alcohol-phenols, alcohol peroxides, ether peroxides, ketone peroxides (whether or not chemically defined), and their halogenated, sulphonated, nitrated or nitrosated derivatives 2910 Epoxides, epoxyalcohols, epoxyphenols and epoxyethers, with a three-membered ring, and their halogenated, sulphonated, nitrated or nitrosated derivatives 2911 00 00 Acetals and hemiacetals, whether or not with other oxygen function, and their halogenated, sulphonated, nitrated or nitrosated derivatives 2912 Aldehydes, whether or not with other oxygen function; cyclic polymers of aldehydes; paraformaldehyde 2913 00 00 Halogenated, sulphonated, nitrated or nitrosated derivatives of products under heading 2912 2914 Ketones and quinones, whether or not with other oxygen function, and their halogenated, sulphonated, nitrated or nitrosated derivatives 2915 Saturated acyclic monocarboxylic acids and their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulphonated, nitrated or nitrosated derivatives 2916 Unsaturated acyclic monocarboxylic acids, cyclic monocarboxylic acids, their anhydrides, halides, peroxides and peroxyacids, and their halogenated, sulphonated, nitrated or nitrosated derivatives 2917 Polycarboxylic acids, their anhydrides, halides, peroxides and peroxyacids and their halogenated, sulphonated, nitrated or nitrosated derivatives 2918 Carboxylic acids with additional oxygen function and their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulphonated, nitrated or nitrosated derivatives 2919 Phosphoric esters and their salts, including lactophosphates; their halogenated, sulphonated, nitrated or nitrosated derivatives 2920 Esters of other inorganic acids of non-metals (excluding esters of hydrogen halides) and their salts; their halogenated, sulphonated, nitrated or nitrosated derivatives 2921 Amine-function compounds 2922 Oxygen-function amino-compounds 2923 Quaternary ammonium salts and hydroxides; lecithins and other phosphoaminolipids, whether or not chemically defined 2924 Carboxyamide-function compounds and amide-function compounds of carbonic acid 2925 Carboxyimide-function compounds (including saccharin and its salts) and imine-function compounds 2926 Nitrile-function compounds 2927 00 00 Diazo-, azo- or azoxy-compounds 2928 00 90 Other organic derivatives of hydrazine or of hydroxylamine 2929 10 Isocyanates 2929 90 00 Other compounds with other nitrogen function 2930 20 00 Thiocarbamates and dithiocarbamates, and thiuram mono-, di- or tetrasulphides; dithiocarbonates (xanthates) 2930 30 00 ex 2930 90 99 2930 40 90 Methionine, captafol (ISO), methamidophos (ISO), and other organo-sulphur compounds other than dithiocarbonates (xanthates) 2930 50 00 2930 90 13 2930 90 16 2930 90 20 2930 90 60 ex 2930 90 99 2931 00 Other organo-inorganic compounds 2932 Heterocyclic compounds with oxygen hetero-atom(s) only 2933 Heterocylic compounds with nitrogen hetero-atom(s) only 2934 Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds 2935 00 90 Other sulphonamides 2938 Glycosides, natural or reproduced by synthesis, and their salts, ethers, esters and other derivatives 2940 00 00 Sugars, chemically pure, other than sucrose, lactose, maltose, glucose and fructose; sugar ethers, sugar acetals and sugar esters, and their salts, other than products under heading 2937, 2938 or 2939 Corrected according to CN description 2941 20 30 Dihydrostreptomycin, its salts, esters and hydrates 2942 00 00 Other organic compounds S-6b 31 3102 Mineral or chemical fertilisers, nitrogenous 3103 10 Superphosphates 3105 Mineral or chemical fertilisers containing two or three of the fertilising elements nitrogen, phosphorus and potassium; other fertilisers; goods of Chapter 31 in tablets or similar forms or in packages of a gross weight not exceeding 10 kg 32 ex Chapter 32 Tanning or dyeing extracts; tannins and their derivatives; dyes, pigments and other colouring matter; paints and varnishes; putty and other mastics; inks; excluding products under subheadings 3201 20 00, 3201 90 20, ex 3201 90 90 (tanning extracts of eucalyptus), ex 3201 90 90 (tanning extracts derived from gambier and myrobalan fruits) and ex 3201 90 90 (other tanning extracts of vegetable origin) 33 Chapter 33 Essential oils and resinoids; perfumery, cosmetic or toilet preparations 34 Chapter 34 Soap, organic surface-active agents, washing preparations, lubricating preparations, artificial waxes, prepared waxes, polishing or scouring preparations, candles and similar articles, modelling pastes, \u2018dental waxes\u2019 and dental preparations with a basis of plaster 35 3501 Casein, caseinates and other casein derivatives; casein glues 3502 90 90 Albuminates and other albumin derivatives 3503 00 Gelatin (including gelatin in rectangular (including square) sheets, whether or not surface-worked or coloured) and gelatin derivatives; isinglass; other glues of animal origin, excluding casein glues of heading 3501 3504 00 00 Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed 3505 10 50 Starches, esterified or etherified 3506 Prepared glues and other prepared adhesives, not elsewhere specified or included; products suitable for use as glues or adhesives, put up for retail sale as glues or adhesives, not exceeding a net weight of 1 kg 3507 Enzymes; prepared enzymes not elsewhere specified or included 36 Chapter 36 Explosives; pyrotechnic products; matches; pyrophoric alloys; certain combustible preparations 37 Chapter 37 Photographic or cinematographic goods 38 ex Chapter 38 Miscellaneous chemical products excluding the products under subheadings 3809 10 and 3824 60 S-7a 39 Chapter 39 Plastics and articles thereof S-7b 40 Chapter 40 Rubber and articles thereof S-8a 41 ex 4104 Tanned or crust hides and skins of bovine (including buffalo) or equine animals, without hair on, whether or not split, but not further prepared, excluding the products under subheadings 4104 41 19 and 4104 49 19 ex 4106 31 00 Tanned or crust hides and skins of swine, without hair on, in the wet state (including wet-blue), split but not further prepared, or in the dry state (crust), whether or not split, but not further prepared 4106 32 00 4107 Leather further prepared after tanning or crusting, including parchment-dressed leather, of bovine (including buffalo) or equine animals, without hair on, whether or not split, other than leather of heading 4114 4112 00 00 Leather further prepared after tanning or crusting, including parchment-dressed leather, of sheep or lamb, without wool on, whether or not split, other than leather of heading 4114 4113 Leather further prepared after tanning or crusting, including parchment-dressed leather, of other animals, without wool or hair on, whether or not split, other than leather of heading 4114, 4114 Chamois (including combination chamois) leather; patent leather and patent laminated leather; metallised leather 4115 10 00 Composition leather with a basis of leather or leather fibre, in slabs, sheets or strip, whether or not in rolls S-8b 42 Chapter 42 Articles of leather; saddlery and harness; travel goods, handbags and similar containers; articles of animal gut (other than silkworm gut) 43 Chapter 43 Furskins and artificial fur; manufactures thereof S-9a 44 Chapter 44 Wood and articles of wood, wood charcoal S-9b 45 Chapter 45 Cork and articles of cork 46 Chapter 46 Manufactures of straw, of esparto or of other plaiting materials; basketware and wickerwork S-11a 50 Chapter 50 Silk 51 ex Chapter 51 Wool, fine or coarse animal hair, excluding the products under heading 5105; horsehair yarn and woven fabric 52 Chapter 52 Cotton 53 Chapter 53 Other vegetable textile fibres; paper yarn and woven fabrics of paper yarn 54 Chapter 54 Man-made filaments; strip and the like of man-made textile materials 55 Chapter 55 Man-made staple fibres 56 Chapter 56 Wadding, felt and non-wovens; special yarns; twine, cordage, ropes and cables and articles thereof 57 Chapter 57 Carpets and other textile floor coverings 58 Chapter 58 Special woven fabrics; tufted textile fabrics; lace; tapestries; trimmings; embroidery 59 Chapter 59 Impregnated, coated, covered or laminated textile fabrics; textile articles of a kind suitable for industrial use 60 Chapter 60 Knitted or crocheted fabrics S-11b 61 Chapter 61 Articles of apparel and clothing accessories, knitted or crocheted 62 Chapter 62 Articles of apparel and clothing accessories, not knitted or crocheted 63 Chapter 63 Other made-up textile articles; sets; worn clothing and worn textile articles; rags S-12a 64 Chapter 64 Footwear, gaiters and the like; parts of such articles S-12b 65 Chapter 65 Headgear and parts thereof 66 Chapter 66 Umbrellas, sun umbrellas, walking sticks, seat-sticks, whips, riding-crops and parts thereof 67 Chapter 67 Prepared feathers and down and articles made of feathers or of down; artificial flowers; articles of human hair S-13 68 Chapter 68 Articles of stone, plaster, cement, asbestos, mica or similar materials 69 Chapter 69 Ceramic products 70 Chapter 70 Glass and glassware S-14 71 Chapter 71 Natural or cultured pearls, precious or semi-precious stones, precious metals, metals clad with precious metal, and articles thereof; imitation jewellery; coin S-15a 72 7202 Ferro-alloys 73 Chapter 73 Articles of iron or steel S-15b 74 Chapter 74 Copper and articles thereof 75 7505 12 00 Bars, rods and profiles, of nickel alloys 7505 22 00 Wire, of nickel alloys 7506 20 00 Plates, sheets, strip and foil, of nickel alloys 7507 20 00 Nickel tube or pipe fittings 76 ex Chapter 76 Aluminium and articles thereof, excluding the products under heading 7601 78 ex Chapter 78 Lead and articles thereof, except for products of subheading 7801 99 7801 99 Unwrought lead other than refined and other than containing by weight antimony as the principal other element 79 ex Chapter 79 Zinc and articles thereof, excluding the products under headings 7901 and 7903 81 ex Chapter 81 Other base metals; cermets; articles thereof, excluding the products under subheadings 8101 10 00, 8101 94 00, 8102 10 00, 8102 94 00, 8104 11 00, 8104 19 00, 8107 20 00, 8108 20 00, 8108 30 00, 8109 20 00, 8110 10 00, 8112 21 90, 8112 51 00, 8112 59 00, 8112 92 and 8113 00 20 82 Chapter 82 Tools, implements, cutlery, spoons and forks, of base metal; parts thereof, of base metal 83 Chapter 83 Miscellaneous articles of base metal S-16 84 Chapter 84 Nuclear reactors, boilers, machinery and mechanical appliances, and parts thereof 85 Chapter 85 Electrical machinery and equipment and parts thereof; sound recorders and reproducers, television image and sound recorders and reproducers, and parts and accessories of such articles S-17a 86 Chapter 86 Railway or tramway locomotives, rolling stock and parts thereof; railway or tramway track fixtures and fittings and parts thereof; mechanical (including electromechanical) traffic-signalling equipment of all kinds S-17b 87 Chapter 87 Vehicles other than railway or tramway rolling stock, and parts and accessories thereof 88 Chapter 88 Aircraft, spacecraft, and parts thereof 89 Chapter 89 Ships, boats and floating structures S-18 90 Chapter 90 Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus; parts and accessories thereof 91 Chapter 91 Clocks and watches and parts thereof 92 Chapter 92 Musical instruments; parts and accessories of such articles S-20 94 Chapter 94 Furniture; bedding, mattresses, mattress supports, cushions and similar stuffed furnishings; lamps and lighting fittings, not elsewhere specified or included; illuminated signs, illuminated nameplates and the like; prefabricated buildings 95 Chapter 95 Toys, games and sports requisites; parts and accessories thereof 96 Chapter 96 Miscellaneous manufactured articles (1) For the products under subheading 0306 13, the duty shall be 3,6 %. (2) For the products under subheading 1704 10 90, the specific duty shall be limited to 16 % of the customs value. ANNEX X CORRELATION TABLE Regulation (EC) No 732/2008 This Regulation Article 1 Article 1 \u2014 Article 2, point (a) Article 2, point (a) Article 2, point (g) Article 2, point (b) Article 2, point (h) Article 2, point (c) Article 2, points (b) to (f) \u2014 Article 2, point (i) \u2014 Article 2, point (j) \u2014 Article 2, point (k) \u2014 Article 2, point (l) Article 3(1) and Article 3(2), first subparagraph Article 4(1) Article 3(2), second subparagraph \u2014 Article 3(3) Article 5(4) \u2014 Article 4(2) and (3) Article 4 Article 6(1) and Article 11(1) Article 5(1) and (2) Article 33(1) and (2) Article 5(3) \u2014 Article 6(1) to (6) Article 7(1) to (6) Article 6(7) \u2014 Article 7(1) and (2) Article 12(1) and (2) Article 7(3) \u2014 Article 8(1) Article 9(1) \u2014 Article 9(2) Article 8(2) Annex VII Article 8(3), first subparagraph Article 13(1) \u2014 Article 13(2) Article 8(3), second subparagraph Article 14(1) \u2014 Article 14(2) and (3) Article 9(1) and (2) Article 10(1) and (2) Article 9(3) \u2014 \u2014 Article 10(3) Article 10(1) \u2014 Article 10(2) Article 10(4) \u2014 Article 10(5) Article 10(3) Article 10(6) Article 10(4) \u2014 Article 10(5) \u2014 Article 10(6) \u2014 \u2014 Article 10(7) \u2014 Article 16 Article 11(1) to (7) Article 18 Article 11(8) Article 17 Article 12 \u2014 Article 13 Article 8 and Annex VI Article 14 Article 34 Article 15(1) Article 19(1) Article 15(2) Article 15(1) \u2014 Article 15(2) Article 15(3) Article 19(2) \u2014 Article 20 Article 16 Article 21 Article 17 Article 15(3) and Article 19(3) Article 18 Article 15(4) to (7) and Article 19(4) to (7) Article 19 Article 15(8) to (12) and Article 19(8) to (14) Article 20(1) Article 22 Article 20(2) and (3) Article 24(1) to (3) Article 20(4) Article 23 Article 20(5) Article 10(4) Article 20(6) Article 26 Article 20(7) Article 25 \u2014 Article 27 \u2014 Article 28 Article 20(8) Article 29 Article 21 Article 30 Article 22(1) Article 31 Article 22(2) \u2014 Article 23 Article 32 Article 24 \u2014 Article 25, point (a) Article 6(2) and Article 11(2) Article 25, point (b) Article 3(3) and Article 17(2) and (3) Article 25, point (c) Article 5(2) Article 25, point (d) Article 8(3) Article 25, point (e) Article 10(4) Article 26 Article 35 \u2014 Article 36 \u2014 Article 37 \u2014 Article 38 Article 27(1) and (2) Article 39(1) Article 27(3) \u2014 Article 27(4) and (5) Article 39(2) to (4) Article 28 \u2014 Article 29 \u2014 Article 30 \u2014 Article 31 \u2014 \u2014 Article 40 \u2014 Article 41 \u2014 Article 42 Article 32(1) Article 43(1) Article 32(2) Article 43(2) and (3) \u2014 Annex I Annex I Annexes II, III and IV Annex II Annexes V and IX Annex III, Part A Annex VIII, Part A Annex III, Part B Annex VIII, Part B \u2014 Annex X", "summary": "Preferential European Union import tariffs for developing countries Preferential European Union import tariffs for developing countries SUMMARY OF: Regulation (EU) No 978/2012 applying a scheme of generalised tariff preferences WHAT IS THE AIM OF THE REGULATION? In 2012, the European Union (EU) agreed on new rules to refocus this scheme, which has been in place since 1971. These rules make the system more transparent and predictable for beneficiary countries, especially in view of the changed global trade patterns over the past decade. The scheme is now directed at those countries in greatest need. The regulation does not include countries that already enjoy preferences under free trade agreements with the EU, or under autonomous arrangements with the EU (usually temporary, pending the conclusion of more comprehensive, longer-term agreements with the EU). KEY POINTS The EU\u2019s scheme of generalised tariff preferences (GSP) allows developing countries to pay lower tariffs on their exports to the EU. This helps boost their economies. Three strands of the scheme Standard GSP. Tariffs for goods imported from a developing country are reduced or suspended. Exception: this does not apply if a country has been classified by the World Bank as a high or upper-middle income country for 3 consecutive years immediately before the EU updates the list of beneficiary countries. GSP+ (incentive scheme). Even lower tariffs for countries that ratify and implement 27 specified international conventions covering human and labour rights, environment and good governance. Everything but arms for least-developed countries. Full tariff and quota-free imports for all goods from the United Nations-defined least developed countries, except for arms. Suspension of countries The EU may temporarily suspend the lower tariffs for reasons such as: violations of core principles in human and labour rights conventions; unfair trading practices; serious shortcomings in customs controls (e.g. export or transit of illegal drugs); the national law of a GSP+ beneficiary country no longer incorporates the relevant conventions (or that law not being effectively implemented). Discontinuation as countries develop Some countries can be poor but still develop highly competitive export industries. Once this happens, they no longer need preferences to successfully penetrate EU markets. The GSP scheme therefore withdraws preferences from countries with such competitive product sectors on the basis of a graduation mechanism. More stable and predictable The new GSP offers importers and exporters more stability and predictability, because it now lasts 10 years (as opposed to 3 years in the past). Exporters know that \u2013 where changes are made in the beneficiary list \u2013 there are transition periods of at least 1 year. Countries now have the security of knowing that they can be removed from the beneficiary lists only if the United Nations lists them as high or upper-middle income countries 3 years in a row. Temporary import restrictions The EU may apply safeguard measures (temporary restrictions) if imports from beneficiary countries cause or threaten to cause serious difficulty to an EU producer. It may also apply surveillance measures for farm products. None of these measures have ever been taken in the history of the scheme. List of beneficiary countries Regulation (EU) No 978/2012 is being amended through implementing and delegated acts so as to update the list of the countries benefiting from tariff preferences under the GSP+. See latest consolidated version. FROM WHEN DOES THE REGULATION APPLY? It has applied since 20 November 2012. BACKGROUND For further information, see: Generalised scheme of preferences (European Commission). MAIN DOCUMENT Regulation (EU) No 978/2012 of the European Parliament and of the Council of 25 October 2012 applying a scheme of generalised tariff preferences and repealing Council Regulation (EC) No 732/2008 (OJ L 303, 31.10.2012, pp. 1\u201382). Successive amendments to Regulation (EU) No 978/2012 have been incorporated into the basic text. This consolidated version is for reference only. RELATED DOCUMENTS Commission Delegated Regulation (EU) No 155/2013 of 18 December 2012 establishing rules related to the procedure for granting the special incentive arrangement for sustainable development and good governance under Regulation (EU) No 978/2012 of the European Parliament and of the Council applying a scheme of generalised tariff preferences (OJ L 48, 21.2.2013, pp. 5\u20137). Commission Delegated Regulation (EU) No 1083/2013 of 28 August 2013 establishing rules related to the procedure for temporary withdrawal of tariff preferences and adoption of general safeguard measures under Regulation (EU) No 978/2012 of the European Parliament and the Council applying a scheme of generalised tariff preferences (OJ L 293, 5.11.2013, pp. 16\u201321). Regulation (EU) No 607/2013 of the European Parliament and of the Council of 12 June 2013 repealing Council Regulation (EC) No 552/97 temporarily withdrawing access to generalised tariff preferences from Myanmar/Burma (OJ L 181, 29.6.2013, pp. 13\u201314). last update 03.02.2022"}
{"article": "30.3.2012 EN Official Journal of the European Union L 94/1 REGULATION (EU) No 258/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 March 2012 implementing Article 10 of the United Nations\u2019 Protocol against the illicit manufacturing of and trafficking in firearms, their parts and components and ammunition, supplementing the United Nations Convention against Transnational Organised Crime (UN Firearms Protocol), and establishing export authorisation, and import and transit measures for firearms, their parts and components and ammunition THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national Parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) In accordance with Council Decision 2001/748/EC of 16 October 2001 concerning the signing on behalf of the European Community of the United Nations Protocol on the illicit manufacturing of and trafficking in firearms, their parts, components and ammunition, annexed to the Convention against transnational organised crime (2), the Commission signed that Protocol (hereinafter referred to as the \u2018UN Firearms Protocol\u2019) on behalf of the Community on 16 January 2002. (2) The UN Firearms Protocol, the purpose of which is to promote, facilitate and strengthen cooperation among Parties in order to prevent, combat and eradicate the illicit manufacturing of and trafficking in firearms, their parts and components and ammunition, entered into force on 3 July 2005. (3) In order to facilitate the tracing of firearms and efficiently combat illicit trafficking in firearms, their parts and essential components and ammunition, it is necessary to improve the exchange of information between Member States, in particular through the better use of existing communication channels. (4) Personal data must be processed in accordance with the rules laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (3) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (4). (5) In its Communication of 18 July 2005 on measures to ensure greater security in explosives, detonators, bomb-making equipment and firearms (5), the Commission announced its intention to implement Article 10 of the UN Firearms Protocol as part of the measures which need to be taken in order for the Union to be in a position to conclude that Protocol. (6) The UN Firearms Protocol requires Parties to put in place or improve administrative procedures or systems to exercise effective control over the manufacturing, marking, import and export of firearms. (7) Compliance with the UN Firearms Protocol also requires that illicit manufacture of or trafficking in firearms, their parts and essential components and ammunition be established as criminal offences, and that measures be taken to enable the confiscation of items so manufactured or trafficked. (8) This Regulation should not apply to firearms, their parts and essential components or ammunition that are intended specifically for military purposes. The measures to meet the requirements of Article 10 of the UN Firearms Protocol should be adapted to provide for simplified procedures for firearms for civilian use. Consequently, some facilitation with regard to authorisation for multiple shipments, transit measures and temporary exports for lawful purposes should be ensured. (9) This Regulation does not affect the application of Article 346 of the Treaty on the Functioning of the European Union, which refers to essential interests of the security of the Member States, nor has this Regulation any impact on Directive 2009/43/EC of the European Parliament and of the Council of 6 May 2009 simplifying terms and conditions of transfers of defence-related products within the Community (6), or on Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons (7). Moreover, the UN Firearms Protocol, and consequently this Regulation, do not apply to State-to-State transactions or to State transfers in cases where the application of the Protocol would prejudice the right of a State Party to take action in the interest of national security consistent with the Charter of the United Nations. (10) Directive 91/477/EEC addresses transfers of firearms for civilian use within the territory of the Union, while this Regulation focuses on measures in respect of export from the customs territory of the Union to or through third countries. (11) Firearms, their parts and essential components and ammunition when imported from third countries are subject to Union law and, in particular, to the requirements of Directive 91/477/EEC. (12) Consistency should be ensured with regard to record-keeping provisions in force under Union law. (13) In order to ensure that this Regulation is properly applied, Member States should take measures giving the competent authorities appropriate powers. (14) In order to maintain the list of firearms, their parts and essential components and ammunition for which an authorisation is required under this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of aligning Annex I to this Regulation to Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (8), and to Annex I to Directive 91/477/EEC. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (15) The Union has adopted a body of customs rules, contained in Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (9) and its implementing provisions as laid down in Commission Regulation (EEC) No 2454/93 (10). Consideration should also be given to Regulation (EC) No 450/2008 of the European Parliament and of the Council of 23 April 2008 laying down the Community Customs Code (Modernised Customs Code) (11) whose provisions are applicable in different phases according to Article 188 thereof. Nothing in this Regulation constrains any powers under and pursuant to the Community Customs Code and its implementing provisions. (16) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive. (17) This Regulation is without prejudice to the Union regime for the control of exports, transfer, brokering and transit of dual-use items established by Council Regulation (EC) No 428/2009 (12). (18) This Regulation is consistent with the other relevant provisions on firearms, their parts, essential components and ammunition for military use, security strategies, illicit trafficking in small arms and light weapons and exports of military technology, including Council Common Position 2008/944/CFSP of 8 December 2008 defining common rules governing control of exports of military technology and equipment (13). (19) The Commission and the Member States should inform each other of the measures taken under this Regulation and of other relevant information at their disposal in connection with this Regulation. (20) This Regulation does not prevent the Member States from applying their constitutional rules relating to public access to official documents, taking into account Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (14), HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT, DEFINITIONS AND SCOPE Article 1 This Regulation lays down rules governing export authorisation, and import and transit measures for firearms, their parts and essential components and ammunition, for the purpose of implementing Article 10 of the United Nations Protocol against the Illicit Manufacturing of and Trafficking in Firearms, their Parts and Components and Ammunition, supplementing the United Nations Convention against Transnational Organised Crime (the \u2018UN Firearms Protocol\u2019). Article 2 For the purposes of this Regulation: (1) \u2018firearm\u2019 means any portable barrelled weapon that expels, is designed to expel or may be converted to expel, a shot, bullet or projectile by the action of a combustible propellant as referred to in Annex I. An object is considered as capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if: \u2014 it has the appearance of a firearm, and \u2014 as a result of its construction or the material from which it is made, it can be so converted; (2) \u2018parts\u2019 means any element or replacement element as referred to in Annex I specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm; (3) \u2018essential components\u2019 means the breech-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted; (4) \u2018ammunition\u2019 means the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles that are used in a firearm, as referred to in Annex I, provided that those components are themselves subject to authorisation in the relevant Member State; (5) \u2018deactivated firearms\u2019 means objects otherwise corresponding to the definition of a firearm which have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or modification that would permit the firearm to be reactivated in any way. Member States shall make arrangements for these deactivation measures to be verified by a competent authority. Member States shall, in the context of that verification, provide for the issue of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm; (6) \u2018export\u2019 means: (a) an export procedure within the meaning of Article 161 of Regulation (EEC) No 2913/92; (b) a re-export within the meaning of Article 182 of Regulation (EEC) No 2913/92 but not including goods moving under the external transit procedure, as referred to in Article 91 of that Regulation where no re-export formalities as referred to in Article 182(2) thereof have been fulfilled; (7) \u2018person\u2019 means a natural person, a legal person and, where the possibility is provided for under the rules in force, an association of persons recognised as having the capacity to perform legal acts but lacking the legal status of a legal person; (8) \u2018exporter\u2019 means any person, established in the Union, who makes or on whose behalf an export declaration is made, that is to say the person who, at the time when the declaration is accepted, holds the contract with the consignee in the third country and has the power for determining the sending of the item out of the customs territory of the Union. If no export contract has been concluded or if the holder of the contract does not act on its own behalf, the exporter shall mean the person who has the power for determining the sending of the item out of the customs territory of the Union. Where the benefit of a right to dispose of firearms, their parts and essential components or ammunition accrues to a person established outside the Union pursuant to the contract on which the export is based, the exporter shall be considered to be the contracting party established in the Union; (9) \u2018customs territory of the Union\u2019 means the territory within the meaning of Article 3 of Regulation (EEC) No 2913/92; (10) \u2018export declaration\u2019 means the act whereby a person indicates in the prescribed form and manner his intention to place firearms, their parts and essential components, and ammunition under an export procedure; (11) \u2018temporary export\u2019 means the movement of firearms leaving the customs territory of the Union and intended for re-importation within a period not exceeding 24 months; (12) \u2018transit\u2019 means the operation of transport of goods leaving the customs territory of the Union and passing through the territory of one or more third countries with final destination in another third country; (13) \u2018transhipment\u2019 means transit involving the physical operation of unloading goods from the importing means of transport followed by reloading, for the purpose of re-exportation, generally onto another means of transport; (14) \u2018export authorisation\u2019 means: (a) a single authorisation or licence granted to one specific exporter for one shipment of one or more firearms, their parts and essential components and ammunition to one identified final recipient or consignee in a third country; or (b) a multiple authorisation or licence granted to one specific exporter for multiple shipments of one or more firearms, their parts and essential components and ammunition to one identified final recipient or consignee in a third country; or (c) a global authorisation or licence granted to one specific exporter for multiple shipments of one or more firearms, their parts and essential components and ammunition to several identified final recipients or consignees in one or several third countries; (15) \u2018illicit trafficking\u2019 means the import, export, sale, delivery, movement or transfer of firearms, their parts and essential components or ammunition from or across the territory of one Member State to that of a third country, if any of the following applies: (a) the Member State concerned does not authorise it in accordance with the terms of this Regulation; (b) the firearms are not marked in accordance with Article 4(1) and (2) of Directive 91/477/EEC; (c) the imported firearms are not marked at the time of import at least with a simple marking permitting identification of the first country of import within the European Union, or, where the firearms do not bear such a marking, a unique marking identifying the imported firearms; (16) \u2018tracing\u2019 means the systematic tracking of firearms and, where possible, their parts and essential components and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and trafficking. Article 3 1. This Regulation shall not apply to: (a) State to State transactions or State transfers; (b) firearms, their parts and essential components and ammunition if specially designed for military use and, in any case, firearms of the fully automatic firing type; (c) firearms, their parts and essential components and ammunition when destined for the armed forces, the police, or the public authorities of the Member States; (d) collectors and bodies concerned with cultural and historical aspects of firearms, their parts and essential components and ammunition and recognised as such for the purpose of this Regulation by the Member State in whose territory they are established, provided that tracing measures are ensured; (e) deactivated firearms; (f) antique firearms and their replicas as defined in accordance with national legislation, provided that antique firearms do not include firearms manufactured after 1899. 2. This Regulation is without prejudice to Regulation (EEC) No 2913/92 (Community Customs Code), Regulation (EEC) No 2454/93 (implementing provisions of the Community Customs Code), Regulation (EC) No 450/2008 (Modernised Customs Code), and to the regime for the control of exports, transfer, brokering and transit of dual-use items established by Regulation (EC) No 428/2009 (Dual Use Regulation). CHAPTER II EXPORT AUTHORISATION, PROCEDURES AND CONTROLS AND IMPORT AND TRANSIT MEASURES Article 4 1. An export authorisation established in accordance with the form set out in Annex II shall be required for the export of firearms, their parts and essential components and ammunition listed in Annex I. Such authorisation shall be granted by the competent authorities of the Member State where the exporter is established and shall be issued in writing or by electronic means. 2. Where the export of firearms, their parts, essential components and ammunition requires an export authorisation pursuant to this Regulation and that export is also subject to authorisation requirements in accordance with Common Position 2008/944/CFSP, Member States may use a single procedure to carry out the obligations imposed on them by this Regulation and by that Common Position. 3. If the firearms, their parts and essential components and ammunition are located in one or more Member States other than the one where the application for export authorisation has been made, that fact shall be indicated on that application. The competent authorities of the Member State to which the application for export authorisation has been made shall immediately consult the competent authorities of the Member State or States in question and provide the relevant information. The Member State or States consulted shall make known within 10 working days any objections it or they may have to the granting of such an authorisation, which shall bind the Member State in which the application has been made. Article 5 The Commission shall be empowered to adopt delegated acts in accordance with Article 6 to amend Annex I on the basis of the amendments to Annex I to Regulation (EEC) No 2658/87, and on the basis of the amendments to Annex I to Directive 91/477/EEC. Article 6 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 5 shall be conferred on the Commission for an indeterminate period of time. 3. The delegation of power referred to in Article 5 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 5 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 7 1. Before issuing an export authorisation for firearms, their parts and essential components and ammunition, the Member State concerned shall verify that: (a) the importing third country has authorised the relevant import; and (b) the third countries of transit, if any, have given notice in writing \u2014 and at the latest prior to shipment \u2014 that they have no objection to the transit. This provision does not apply: \u2014 to shipments by sea or air and through ports or airports of third countries provided that that there is no transhipment or change of means of transport, \u2014 in the case of temporary exports for verifiable lawful purposes, which include hunting, sport shooting, evaluation, exhibitions without sale, and repair. 2. Member States may decide that, if no objections to the transit are received within 20 working days from the day of the written request for no objection to the transit submitted by the exporter, the consulted third country of transit shall be regarded as having no objection to the transit. 3. The exporter shall supply the competent authority of the Member State responsible for issuing the export authorisation with the necessary documents proving that the importing third country has authorised the import and that the third country of transit had no objection to the transit. 4. Member States shall process applications for export authorisations within a period of time to be determined by national law or practice, which shall not exceed 60 working days, from the date on which all required information has been provided to the competent authorities. Under exceptional circumstances and for duly justified reasons, that period may be extended to 90 working days. 5. The period of validity of an export authorisation shall not exceed the period of validity of the import authorisation. Where the import authorisation does not specify a period of validity, except under exceptional circumstances and for duly justified reasons, the period of validity of an export authorisation shall be at least nine months. 6. Member States may decide to make use of electronic documents for the purpose of processing the applications for export authorisation. Article 8 1. For the purpose of tracing, the export authorisation and the import licence or import authorisation issued by the importing third country and the accompanying documentation shall together contain information that includes: (a) the dates of issue and expiry; (b) the place of issue; (c) the country of export; (d) the country of import; (e) whenever applicable, the third country or countries of transit; (f) the consignee; (g) the final recipient, if known at the time of the shipment; (h) particulars enabling the identification of the firearms, their parts and essential components and ammunition, and the quantity thereof including, at the latest prior to the shipment, the marking applied to the firearms. 2. The information referred to in paragraph 1, if contained in the import licence or import authorisation, shall be provided by the exporter in advance to the third countries of transit, at the latest prior to the shipment. Article 9 1. Simplified procedures for the temporary export or the re-export of firearms, their parts, essential components and ammunition shall apply as follows: (a) No export authorisation shall be required for: (i) the temporary export by hunters or sport shooters as part of their accompanied personal effects, during a journey to a third country, provided that they substantiate to the competent authorities the reasons for the journey, in particular by producing an invitation or other proof of the hunting or sport shooting activities in the third country of destination, of: \u2014 one or more firearms, \u2014 their essential components, if marked, as well as parts, \u2014 their related ammunition, limited to a maximum of 800 rounds for hunters and a maximum of 1 200 rounds for sport shooters; (ii) the re-export by hunters or sport shooters as part of their accompanied personal effects following temporary admission for hunting or sport shooting activities, provided that the firearms remain the property of a person established outside the customs territory of the Union and the firearms are re-exported to that person. (b) When leaving the customs territory of the Union through a Member State other than the Member State of their residence, hunters and sport shooters shall produce to the competent authorities a European Firearms Pass as provided for in Articles 1 and 12 of Directive 91/477/EEC. In the case of travel by air, the European Firearms Pass shall be produced to the competent authorities where the relevant items are handed over to the airline for transport out of the customs territory of the Union. When leaving the customs territory of the Union through the Member State of their residence, hunters and sport shooters may, instead of a European Firearms Pass, choose to produce another document considered valid for this purpose by the competent authorities of that Member State. (c) The competent authorities of a Member State shall, for a period not exceeding 10 days, suspend the process of export or, if necessary, otherwise prevent firearms, their parts and essential components or ammunition from leaving the customs territory of the Union through that Member State, where they have grounds for suspicion that the reasons substantiated by hunters or sport shooters are not in conformity with the relevant considerations and the obligations laid down in Article 10. In exceptional circumstances and for duly justified reasons, the period referred to in this point may be extended to 30 days. 2. Member States shall, in accordance with national law, establish simplified procedures for: (a) the re-export of firearms following temporary admission for evaluation or exhibition without sale, or inward processing for repair, provided that the firearms remain the property of a person established outside the customs territory of the Union and the firearms are re-exported to that person; (b) the re-export of firearms, their parts and essential components and ammunition if they are held in temporary storage from the moment they enter the customs territory of the Union until their exit; (c) the temporary export of firearms for the purpose of evaluation and repair and exhibition without sale, provided that the exporter substantiates the lawful possession of these firearms and exports them under the outward processing or temporary exportation customs procedures. Article 10 1. In deciding whether to grant an export authorisation under this Regulation, Member States shall take into account all relevant considerations including, where appropriate: (a) their obligations and commitments as parties to the relevant international export control arrangements or relevant international treaties; (b) considerations of national foreign and security policy, including those covered by Common Position 2008/944/CFSP; (c) considerations as to intended end use, consignee, identified final recipient and the risk of diversion. 2. In addition to the relevant considerations set out in paragraph 1, when assessing an application for an export authorisation, Member States shall take into account the application by the exporter of proportionate and adequate means and procedures to ensure compliance with the provisions and objectives of this Regulation and with the terms and conditions of the authorisation. In deciding whether to grant an export authorisation under this Regulation, Member States shall respect their obligations with regard to sanctions imposed by decisions adopted by the Council or by a decision of the Organisation for Security and Cooperation in Europe (OSCE) or by a binding resolution of the Security Council of the United Nations, in particular as regards arms embargoes. Article 11 1. Member States shall: (a) refuse to grant an export authorisation if the applicant has a criminal record concerning conduct constituting an offence listed in Article 2(2) of Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (15), or concerning any other conduct provided that it constituted an offence punishable by a maximum deprivation of liberty of at least four years or a more serious penalty; (b) annul, suspend, modify or revoke an export authorisation if the conditions for granting it are not met or are no longer met. This paragraph is without prejudice to stricter rules under national legislation. 2. Where Member States refuse, annul, suspend, modify or revoke an export authorisation, they shall notify the competent authorities of the other Member States thereof and share the relevant information with them. Where the competent authorities of a Member State have suspended an export authorisation, their final assessment shall be communicated to the other Member States at the end of the period of suspension. 3. Before the competent authorities of a Member State grant an export authorisation under this Regulation, they shall take into account all refusals under this Regulation of which they have been notified, in order to ascertain whether an authorisation has been refused by the competent authorities of another Member State or Member States for an essentially identical transaction (concerning an item with essentially identical parameters or technical characteristics and in respect of the same importer or consignee). They may first consult the competent authorities of the Member State or Member States which issued refusals, annulments, suspensions, modifications or revocations under paragraphs 1 and 2. If, following such consultation, the competent authorities of the Member State decide to grant an authorisation, they shall notify the competent authorities of the other Member States, providing all relevant information to explain the decision. 4. All information shared in accordance with the provisions of this Article shall be in compliance with the provisions of Article 19(2) concerning its confidentiality. Article 12 In accordance with their national law or practice in force, Member States shall keep, for not less than 20 years, all information relating to firearms and, where appropriate and feasible, their parts and essential components and ammunition, which is necessary to trace and identify those firearms, their parts and essential components and ammunition, and to prevent and detect illicit trafficking therein. That information shall include the place, dates of issue and expiry of the export authorisation; the country of export; the country of import; where applicable, the third country of transit; the consignee; the final recipient if known at the time of export; and the description and quantity of the items, including any markings applied to them. This Article shall not apply to exports as referred to in Article 9. Article 13 1. Member States shall, in case of suspicion, request the importing third country to confirm receipt of the dispatched shipment of firearms, their parts and essential components or ammunition. 2. Upon request of a third country of export which is a Party to the UN Firearms Protocol at the time of the export, Member States shall confirm the receipt within the customs territory of the Union of the dispatched shipment of firearms, their parts and essential components or ammunition, which shall be ensured in principle by producing the relevant customs importation documents. 3. Member States shall comply with paragraphs 1 and 2 in accordance with their national law or practice in force. In particular, with regard to exports, the competent authority of the Member State may decide either to address the exporter or to contact the importing third country directly. Article 14 Member States shall take such measures as may be necessary to ensure that their authorisation procedures are secure and that the authenticity of authorisation documents can be verified or validated. Verification and validation may also, where appropriate, be ensured by means of diplomatic channels. Article 15 In order to ensure that this Regulation is properly applied, Member States shall take necessary and proportionate measures to enable their competent authorities to: (a) gather information on any order or transaction involving firearms, their parts and essential components and ammunition; and (b) establish that the export control measures are being properly applied, which may, in particular, include the power to enter the premises of persons with an interest in an export transaction. Article 16 Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. CHAPTER III CUSTOMS FORMALITIES Article 17 1. When completing customs formalities for the export of firearms, their parts and essential components or ammunition at the customs office of export, the exporter shall furnish proof that any necessary export authorisation has been obtained. 2. The exporter may be required to provide a translation into an official language of the Member State where the export declaration is presented of any documents furnished as proof. 3. Without prejudice to any powers conferred on them under Regulation (EEC) No 2913/92, Member States shall, for a period not exceeding 10 days, suspend the process of export from their territory or, if necessary, otherwise prevent firearms, their parts and essential components or ammunition which are covered by a valid export authorisation from leaving the customs territory of the Union through their territory, where they have grounds for suspicion that: (a) relevant information was not taken into account when the authorisation was granted; or (b) circumstances have materially changed since the authorisation was granted. In exceptional circumstances and for duly substantiated reasons, that period may be extended to 30 days. 4. Within the period or extended period referred to in paragraph 3, Member States shall either release the firearms, their parts and essential components or ammunition, or take action pursuant to Article 11(1)(b). Article 18 1. Member States may provide that customs formalities for the export of firearms, their parts and essential components or ammunition can be completed only at customs offices empowered to that end. 2. Member States availing themselves of the option set out in paragraph 1 shall inform the Commission of the duly empowered customs offices or of subsequent changes thereto. The Commission shall publish and update that information on a yearly basis in the C series of the Official Journal of the European Union. CHAPTER IV ADMINISTRATIVE COOPERATION Article 19 1. Member States shall, in cooperation with the Commission and in accordance with Article 21(2), take all appropriate measures to establish direct cooperation and exchange of information between competent authorities with a view to enhancing the efficiency of the measures established by this Regulation. Such information may include: (a) details of exporters whose application for an authorisation is refused, or of exporters who are the subject of decisions taken by Member States pursuant to Article 11; (b) data on consignees or other actors involved in suspicious activities, and, where available, routes taken. 2. Council Regulation (EC) No 515/97 (16) on mutual assistance, and in particular the provisions thereof as to the confidentiality of information, shall apply mutatis mutandis to measures under this Article, without prejudice to Article 20 of this Regulation. CHAPTER V GENERAL AND FINAL PROVISIONS Article 20 1. A Firearms Exports Coordination Group (the \u2018Coordination Group\u2019) chaired by a representative of the Commission shall be set up. Each Member State shall appoint a representative to it. The Coordination Group shall examine any question concerning the application of this Regulation which may be raised either by the Chair or by a representative of a Member State. It shall be bound by the confidentiality rules of Regulation (EC) No 515/97. 2. The Chair of the Coordination Group or the Coordination Group shall, whenever necessary, consult any relevant stakeholders concerned by this Regulation. Article 21 1. Each Member State shall inform the Commission of the laws, regulations and administrative provisions adopted in implementation of this Regulation, including the measures referred to in Article 16. 2. By 19 April 2012, each Member State shall inform the other Member States and the Commission of the national authorities competent for implementing Articles 7, 9, 11 and 17. Based on that information, the Commission shall publish and update a list of those authorities on a yearly basis in the C series of the Official Journal of the European Union. 3. By 19 April 2017, and thereafter upon request of the Coordination Group and in any event every 10 years, the Commission shall review the implementation of this Regulation and present a report to the European Parliament and the Council on its application, which may include proposals for its amendment. Member States shall provide the Commission with all appropriate information for the preparation of the report, including information about the use of the single procedure provided for in Article 4(2). Article 22 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 30 September 2013. However, paragraphs 1 and 2 of Article 13 shall apply from the 30th day after the date on which the UN Firearms Protocol enters into force in the European Union, following its conclusion pursuant to Article 218 of the Treaty on the Functioning of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 14 March 2012. For the European Parliament The President M. SCHULZ For the Council The President N. WAMMEN (1) Position of the European Parliament of 13 October 2011 (not yet published in the Official Journal) and Council Decision of 8 March 2012. (2) OJ L 280, 24.10.2001, p. 5. (3) OJ L 281, 23.11.1995, p. 31. (4) OJ L 8, 12.1.2001, p. 1. (5) COM(2005) 329. The Communication also announced the technical modification of Directive 91/477/EEC aimed at integrating the appropriate provisions required by the UN Protocol as regards intra-Community transfers of weapons concerned by the Directive, finally amended by Directive 2008/51/EC of the European Parliament and of the Council (OJ L 179, 8.7.2008, p. 5). (6) OJ L 146, 10.6.2009, p. 1. (7) OJ L 256, 13.9.1991, p. 51. (8) OJ L 256, 7.9.1987, p. 1. (9) OJ L 302, 19.10.1992, p. 1. (10) OJ L 253, 11.10.1993, p. 1. (11) OJ L 145, 4.6.2008, p. 1. (12) OJ L 134, 29.5.2009, p. 1. (13) OJ L 335, 13.12.2008, p. 99. (14) OJ L 145, 31.5.2001, p. 43. (15) OJ L 190, 18.7.2002, p. 1. (16) Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters (OJ L 82, 22.3.1997, p. 1). ANNEX I (1) List of firearms, their parts and essential components and ammunition Description CN CODE (2) 1 Semi-automatic or repeating short firearms ex 9302 00 00 2 Single-shot short firearms with centre-fire percussion ex 9302 00 00 3 Single-shot short firearms with rimfire percussion whose overall length is less than 28 cm ex 9302 00 00 4 Semi-automatic long firearms whose magazine and chamber can together hold more than three rounds ex 9303 20 10 ex 9303 20 95 ex 9303 30 00 ex 9303 90 00 5 Semi-automatic long firearms whose magazine and chamber cannot together hold more than three rounds, where the loading device is removable or where it is not certain that the weapon cannot be converted, with ordinary tools, into a weapon whose magazine and chamber can together hold more than three rounds. ex 9303 20 10 ex 9303 20 95 ex 9303 30 00 ex 9303 90 00 6 Repeating and semi-automatic long firearms with smooth-bore barrels not exceeding 60 cm in length ex 9303 20 10 ex 9303 20 95 7 Semi-automatic firearms for civilian use which resemble weapons with automatic mechanisms ex 9302 00 00 ex 9303 20 10 ex 9303 20 95 ex 9303 30 00 ex 9303 90 00 8 Repeating long firearms other than those listed in point 6 ex 9303 20 95 ex 9303 30 00 ex 9303 90 00 9 Long firearms with single-shot rifled barrels ex 9303 30 00 ex 9303 90 00 10 Semi-automatic long firearms other than those in points 4 to 7 ex 9303 90 00 11 Single-shot short firearms with rimfire percussion whose overall length is not less than 28 cm ex 9302 00 00 12 Single-shot long firearms with smooth-bore barrels 9303 10 00 ex 9303 20 10 ex 9303 20 95 13 Parts specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm. Any essential component of such firearms: the breech-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted ex 9305 10 00 ex 9305 21 00 ex 9305 29 00 ex 9305 99 00 14 Ammunition: the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the relevant Member State ex 3601 00 00 ex 3603 00 90 ex 9306 21 00 ex 9306 29 00 ex 9306 30 10 ex 9306 30 90 ex 9306 90 90 15 Collections and collectors\u2019 pieces of historical interest Antiques of an age exceeding 100 years ex 9705 00 00 ex 9706 00 00 For the purposes of this Annex: (a) \u2018short firearm\u2019 means a firearm with a barrel not exceeding 30 centimetres or whose overall length does not exceed 60 centimetres; (b) \u2018long firearm\u2019 means any firearm other than a short firearm; (c) \u2018automatic firearm\u2019 means a firearm which reloads automatically each time a round is fired and can fire more than one round with one pull on the trigger; (d) \u2018semi-automatic firearm\u2019 means a firearm which reloads automatically each time a round is fired and can fire only one round with one pull on the trigger; (e) \u2018repeating firearm\u2019 means a firearm which, after a round has been fired, is designed to be reloaded from a magazine or cylinder by means of a manually-operated action; (f) \u2018single-shot firearm\u2019 means a firearm with no magazine which is loaded before each shot by the manual insertion of a round into the chamber or a loading recess at the breech of the barrel. (1) Based on the Combined Nomenclature of goods as laid down in Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff. (2) When an \u2018ex\u2019 code is indicated, the scope is to be determined by application of the CN code and corresponding description taken together. ANNEX II (model for export authorisation forms) (referred to in Article 4 of this Regulation) When granting export authorisations, Member States will strive to ensure the visibility of the nature of the authorisation on the form issued. This is an export authorisation valid in all Member States of the European Union until its expiry date.", "summary": "Firearms \u2014 combating illicit manufacture and trafficking Firearms \u2014 combating illicit manufacture and trafficking SUMMARY OF: Regulation (EU) No 258/2012: implementing the United Nations\u2019 Protocol against the illicit manufacturing of and trafficking in firearms SUMMARY WHAT DOES THIS REGULATION DO? It lays down rules on exporting, importing and transporting firearms, their parts and components, and ammunition. It therefore implements Article 10 (which deals with imports, exports and transit of firearms) of the United Nations Protocol against the Illicit Manufacturing of and Trafficking in Firearms, their Parts and Components and Ammunition. KEY POINTS Annex I to this regulation contains a list of the firearms, their parts and ammunition that require export authorisation. The European Commission has the power to amend this list. The relevant authority of the EU country where a prospective exporter is based may grant export authorisation upon receiving an export authorisation form from that exporter. When exporting firearms, their parts and ammunition outside the EU, an exporter must provide the relevant authority in its own EU country with authorisation from the non-EU country receiving the shipment, and from any non-EU countries through which the shipment will pass. The authority must then process the export authorisation application within 60 days. For traceability purposes, export and import authorisations and their accompanying documentation must contain information including, for example: the place and date of issue, the expiry date, both the country of export and import, transit countries, the final recipient, and a description of and quantity of the firearms, their parts and ammunition. Simplified procedures exist for firearms, their parts and ammunition used for hunting and sports shooting. When deciding whether to grant an export authorisation, EU countries must take into account considerations such as: international treaties and national foreign and security policy. EU countries also need to take account of considerations covered by Council Common Position 2008/994/CFSP which defines EU rules on the control of exports of military technology and equipment. These include aspects such as: risk that the intended recipient would use the military technology or equipment to be exported aggressively against another country or to assert by force a territorial claim, or risk that the military technology or equipment would be diverted within the buyer country or re-exported under undesirable conditions. EU countries must refuse to grant export authorisation if the applicant has a criminal record. In addition, they must annul, suspend, modify or revoke the authorisation if the conditions are no longer met. The regulation does not apply to antique or deactivated firearms, or to firearms intended for military or police use. FROM WHEN DOES THE REGULATION APPLY? It has applied since 30 September 2013. BACKGROUND The UN\u2019s Protocol against the Illicit Manufacturing of and Trafficking in Firearms, their Parts and Components and Ammunition is the only legally binding instrument on small arms at global level. It establishes a set of rules for countries to control and regulate illicit firearms and arms trafficking, prevent their diversion into crime, and facilitate the investigation and prosecution of related offences without hampering legitimate trade. The Protocol supplements the UN Convention against Transnational Organised Crime. For more information, see \u2018Trafficking in firearms\u2019 on the European Commission\u2019s website ACT Regulation (EU) No 258/2012 of the European Parliament and of the Council of 14 March 2012 implementing Article 10 of the United Nations\u2019 Protocol against the illicit manufacturing of and trafficking in firearms, their parts and components and ammunition, supplementing the United Nations Convention against Transnational Organised Crime (UN Firearms Protocol), and establishing export authorisation, and import and transit measures for firearms, their parts and components and ammunition (OJ L 94, 30.3.2012, pp. 1\u201315) RELATED ACTS Council Common Position 2008/944/CFSP of 8 December 2008 defining common rules governing control of exports of military technology and equipment (OJ L 335, 13.12.2008, p. 99\u2013103) last update 21.04.2016"}
{"article": "6.11.2013 EN Official Journal of the European Union L 295/11 REGULATION (EU) No 1052/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 October 2013 establishing the European Border Surveillance System (Eurosur) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2)(d) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) The establishment of a European Border Surveillance System (\u2018EUROSUR\u2019) is necessary in order to strengthen the exchange of information and the operational cooperation between national authorities of Member States as well as with the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union established by Council Regulation (EC) No 2007/2004 (2) (\u2018the Agency\u2019). EUROSUR will provide those authorities and the Agency with the infrastructure and tools needed to improve their situational awareness and reaction capability at the external borders of the Member States of the Union (\u2018external borders\u2019) for the purpose of detecting, preventing and combating illegal immigration and cross-border crime and contributing to ensuring the protection and saving the lives of migrants. (2) The practice of travelling in small and unseaworthy vessels has dramatically increased the number of migrants drowning at the southern maritime external borders. EUROSUR should considerably improve the operational and technical ability of the Agency and the Member States to detect such small vessels and to improve the reaction capability of the Member States, thereby contributing to reducing the loss of lives of migrants. (3) It is recognised in this Regulation that migratory routes are also taken by persons in need of international protection. (4) Member States should establish national coordination centres to improve the exchange of information and the cooperation for border surveillance between them and with the Agency. It is essential for the proper functioning of EUROSUR that all national authorities with a responsibility for external border surveillance under national law cooperate via national coordination centres. (5) This Regulation should not hinder Member States from making their national coordination centres also responsible for coordinating the exchange of information and for cooperation with regard to the surveillance of air borders and for checks at border crossing points. (6) The Agency should improve the exchange of information and the cooperation with other Union bodies, offices and agencies, such as the European Maritime Safety Agency and the European Union Satellite Centre, in order to make best use of information, capabilities and systems which are already available at European level, such as the European Earth monitoring programme. (7) This Regulation forms part of the European model of integrated border management of the external borders and of the Internal Security Strategy of the European Union. EUROSUR will also contribute to the development of the Common Information Sharing Environment (CISE) for the surveillance of the maritime domain of the Union providing a wider framework for maritime situational awareness through information exchange amongst public authorities across sectors in the Union. (8) In order to ensure that the information contained in EUROSUR is as complete and updated as possible, in particular with regard to the situation in third countries, the Agency should cooperate with the European External Action Service. For those purposes, Union delegations and offices should provide all information which may be relevant for EUROSUR. (9) The Agency should provide the necessary assistance for the development and operation of EUROSUR and, as appropriate, for the development of CISE, including the interoperability of systems, in particular by establishing, maintaining and coordinating the EUROSUR framework. (10) The Agency should be provided with the appropriate financial and human resources in order to adequately fulfil the additional tasks assigned to it under this Regulation. (11) This Regulation respects the fundamental rights and observes the principles recognised by Articles 2 and 6 of the Treaty on European Union (TEU) and by the Charter of Fundamental Rights of the European Union, in particular respect for human dignity, the right to life, the prohibition of torture and inhuman or degrading treatment or punishment, the prohibition of trafficking in human beings, the right to liberty and security, the right to the protection of personal data, the right of access to documents, the right to asylum and to protection against removal and expulsion, non-refoulement, non-discrimination and the rights of the child. This Regulation should be applied by Member States and the Agency in accordance with those rights and principles. (12) In accordance with Regulation (EC) No 2007/2004, the Fundamental Rights Officer and the Consultative Forum established by that Regulation should have access to all information concerning respect for fundamental rights in relation to all the activities of the Agency within the framework of EUROSUR. (13) Any exchange of personal data in the European situational picture and the common pre-frontier intelligence picture should constitute an exception. It should be conducted on the basis of existing national and Union law and should respect their specific data protection requirements. Directive 95/46/EC of the European Parliament and of the Council (3), Regulation (EC) No 45/2001 of the European Parliament and of the Council (4) and Council Framework Decision 2008/977/JHA (5) are applicable in cases in which more specific instruments, such as Regulation (EC) No 2007/2004, do not provide a full data protection regime. (14) In order to implement a gradual geographical roll-out of EUROSUR, the obligation to designate and operate national coordination centres should apply in two successive stages: first to the Member States located at the southern and eastern external borders and, at a second stage, to the remaining Member States. (15) This Regulation includes provisions on cooperation with neighbouring third countries, because well-structured and permanent exchange of information and cooperation with those countries, in particular in the Mediterranean region, are key factors for achieving the objectives of EUROSUR. It is essential that any exchange of information and any cooperation between Member States and neighbouring third countries be carried out in full compliance with fundamental rights and in particular with the principle of non-refoulement. (16) This Regulation includes provisions on the possibility of close cooperation with Ireland and the United Kingdom which may assist in better achieving the objectives of EUROSUR. (17) The Agency and the Member States, when implementing this Regulation, should make the best possible use of existing capabilities in terms of human resources as well as technical equipment, both at Union and national level. (18) The Commission should regularly assess the results of the implementation of this Regulation to determine the extent to which the objectives of EUROSUR have been achieved. (19) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (20) This Regulation constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (6); the United Kingdom is therefore not taking part in its adoption and is not bound by it or subject to its application. (21) This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (7); Ireland is therefore not taking part in its adoption and is not bound by it or subject to its application. (22) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters' association with the implementation, application and development of the Schengen acquis (8) which fall within the area referred to in point A of Article 1 of Council Decision 1999/437/EC (9). Norway should establish a national coordination centre in accordance with this Regulation as from 2 December 2013. (23) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (10) which fall within the area referred to in point A of Article 1 of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (11). (24) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (12) which fall within the area referred to in point A of Article 1 of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (13). (25) The implementation of this Regulation does not affect the division of competence between the Union and the Member States or the obligations of Member States under the United Nations Convention on the Law of the Sea, the International Convention for the Safety of Life at Sea, the International Convention on Maritime Search and Rescue, the United Nations Convention against Transnational Organized Crime and its Protocol against the Smuggling of Migrants by Land, Sea and Air, the Convention Relating to the Status of Refugees, the Convention for the Protection of Human Rights and Fundamental Freedoms and other relevant international instruments. (26) The implementation of this Regulation does not affect Regulation (EC) No 562/2006 of the European Parliament and of the Council (14) or the rules for the surveillance of sea external borders in the context of operational cooperation coordinated by the Agency. (27) Since the objective of this Regulation, namely to establish EUROSUR, cannot be sufficiently achieved by Member States alone but can rather, by virtue of its scale and effect, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes a common framework for the exchange of information and for the cooperation between Member States and the Agency in order to improve situational awareness and to increase reaction capability at the external borders of the Member States of the Union (\u2018external borders\u2019) for the purpose of detecting, preventing and combating illegal immigration and cross-border crime and contributing to ensuring the protection and saving the lives of migrants (\u2018EUROSUR\u2019). Article 2 Scope 1. This Regulation shall apply to the surveillance of external land and sea borders, including the monitoring, detection, identification, tracking, prevention and interception of unauthorised border crossings for the purpose of detecting, preventing and combating illegal immigration and cross-border crime and contributing to ensuring the protection and saving the lives of migrants. 2. This Regulation may also apply to the surveillance of air borders as well as to checks at border crossing points if Member States voluntarily provide such information to EUROSUR. 3. This Regulation shall not apply to any legal or administrative measure taken once the responsible authorities of a Member State have intercepted cross-border criminal activities or unauthorised crossings by persons of the external borders. 4. Member States and the Agency shall comply with fundamental rights, in particular the principles of non-refoulement and respect for human dignity and data protection requirements, when applying this Regulation. They shall give priority to the special needs of children, unaccompanied minors, victims of human trafficking, persons in need of urgent medical assistance, persons in need of international protection, persons in distress at sea and other persons in a particularly vulnerable situation. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (a) \u2018Agency\u2019 means the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union established by Regulation (EC) No 2007/2004; (b) \u2018situational awareness\u2019 means the ability to monitor, detect, identify, track and understand illegal cross-border activities in order to find reasoned grounds for reaction measures on the basis of combining new information with existing knowledge, and to be better able to reduce loss of lives of migrants at, along or in the proximity of, the external borders; (c) \u2018reaction capability\u2019 means the ability to perform actions aimed at countering illegal cross-border activities at, along or in the proximity of, the external borders, including the means and timelines to react adequately; (d) \u2018situational picture\u2019 means a graphical interface to present near-real-time data and information received from different authorities, sensors, platforms and other sources, which is shared across communication and information channels with other authorities in order to achieve situational awareness and support the reaction capability along the external borders and the pre-frontier area; (e) \u2018cross-border crime\u2019 means any serious crime with a cross-border dimension committed at, along or in the proximity of, the external borders; (f) \u2018external border section\u2019 means the whole or a part of the external land or sea border of a Member State, as defined by national law or as determined by the national coordination centre or any other responsible national authority; (g) \u2018pre-frontier area\u2019 means the geographical area beyond the external borders; (h) \u2018crisis situation\u2019 means any natural or man-made disaster, accident, humanitarian or political crisis or any other serious situation occurring at, along or in the proximity of, the external borders, which may have a significant impact on the control of the external borders; (i) \u2018incident\u2019 means a situation relating to illegal immigration, cross-border crime or a risk to the lives of migrants at, along or in the proximity of, the external borders. TITLE II FRAMEWORK CHAPTER I Components Article 4 EUROSUR framework 1. For the exchange of information and for the cooperation in the field of border surveillance, and taking into account existing information exchange and cooperation mechanisms, Member States and the Agency shall use the EUROSUR framework, consisting of the following components: (a) national coordination centres; (b) national situational pictures; (c) a communication network; (d) a European situational picture; (e) a common pre-frontier intelligence picture; (f) a common application of surveillance tools. 2. The national coordination centres shall provide the Agency, via the communication network, with information from their national situational pictures which is required for the establishment and maintenance of the European situational picture and of the common pre-frontier intelligence picture. 3. The Agency shall give the national coordination centres, via the communication network, unlimited access to the European situational picture and to the common pre-frontier intelligence picture. 4. The components listed in paragraph 1 shall be established and maintained in line with the principles outlined in the Annex. Article 5 National coordination centre 1. Each Member State shall designate, operate and maintain a national coordination centre which shall coordinate, and exchange information among, all authorities with a responsibility for external border surveillance at national level, as well as with the other national coordination centres and the Agency. Each Member State shall notify the establishment of its national coordination centre to the Commission, which shall forthwith inform the other Member States and the Agency thereof. 2. Without prejudice to Article 17 and within the framework of EUROSUR, the national coordination centre shall be the single point of contact for the exchange of information and for the cooperation with other national coordination centres and with the Agency. 3. The national coordination centre shall: (a) ensure the timely exchange of information and timely cooperation between all national authorities with a responsibility for external border surveillance, as well as with other national coordination centres and the Agency; (b) ensure the timely exchange of information with search and rescue, law enforcement, asylum and immigration authorities at national level; (c) contribute to an effective and efficient management of resources and personnel; (d) establish and maintain the national situational picture in accordance with Article 9; (e) support the planning and implementation of national border surveillance activities; (f) coordinate the national border surveillance system, in accordance with national law; (g) contribute to regularly measuring the effects of national border surveillance activities for the purposes of this Regulation; (h) coordinate operational measures with other Member States, without prejudice to the competences of the Agency and of Member States. 4. The national coordination centre shall operate twenty-four hours a day and seven days a week. Article 6 The Agency 1. The Agency shall: (a) establish and maintain the communication network for EUROSUR in accordance with Article 7; (b) establish and maintain the European situational picture in accordance with Article 10; (c) establish and maintain the common pre-frontier intelligence picture in accordance with Article 11; (d) coordinate the common application of surveillance tools in accordance with Article 12. 2. For the purposes of paragraph 1, the Agency shall operate twenty four hours a day and seven days a week. Article 7 Communication network 1. The Agency shall establish and maintain a communication network in order to provide communication and analytical tools and allow for the exchange of non-classified sensitive and classified information in a secure manner and in near-real-time with, and among, the national coordination centres. The network shall be operational twenty four hours a day and seven days a week and shall allow for: (a) bilateral and multilateral information exchange in near-real-time; (b) audio and video conferencing; (c) secure handling, storing, transmission and processing of non-classified sensitive information; (d) secure handling, storing, transmission and processing of EU classified information up to the level of RESTREINT UE/EU RESTRICTED or equivalent national classification levels, ensuring that classified information is handled, stored, transmitted and processed in a separate and duly accredited part of the communication network. 2. The Agency shall provide technical support and ensure that the communication network is interoperable with any other relevant communication and information system managed by the Agency. 3. The Agency shall exchange, process and store non-classified sensitive and classified information in the communication network in accordance with Article 11d of Regulation (EC) No 2007/2004. 4. The national coordination centres shall exchange, process and store non-classified sensitive and classified information in the communication network in compliance with rules and standards which are equivalent to those set out in the Rules of Procedure of the Commission (15). 5. Member States' authorities, agencies and other bodies using the communication network shall ensure that equivalent security rules and standards as those applied by the Agency are complied with for the handling of classified information. CHAPTER II Situational awareness Article 8 Situational pictures 1. The national situational pictures, the European situational picture and the common pre-frontier intelligence picture shall be produced through the collection, evaluation, collation, analysis, interpretation, generation, visualisation and dissemination of information. 2. The pictures referred to in paragraph 1 shall consist of the following layers: (a) an events layer; (b) an operational layer; (c) an analysis layer. Article 9 National situational picture 1. The national coordination centre shall establish and maintain a national situational picture, in order to provide all authorities with responsibilities for the control and, in particular, surveillance of external borders at national level, with effective, accurate and timely information. 2. The national situational picture shall be composed of information collected from the following sources: (a) the national border surveillance system in accordance with national law; (b) stationary and mobile sensors operated by national authorities with a responsibility for external border surveillance; (c) patrols on border surveillance and other monitoring missions; (d) local, regional and other coordination centres; (e) other relevant national authorities and systems, including liaison officers, operational centres and contact points; (f) the Agency; (g) national coordination centres in other Member States; (h) authorities of third countries, on the basis of bilateral or multilateral agreements and regional networks as referred to in Article 20; (i) ship reporting systems in accordance with their respective legal bases; (j) other relevant European and international organisations; (k) other sources. 3. The events layer of the national situational picture shall consist of the following sub-layers: (a) a sub-layer on unauthorised border crossings, including information available to the national coordination centre on incidents relating to a risk to the lives of migrants; (b) a sub-layer on cross-border crime; (c) a sub-layer on crisis situations; (d) a sub-layer on other events, which contains information on unidentified and suspect vehicles, vessels and other craft and persons present at, along or in the proximity of, the external borders of the Member State concerned, as well as any other event which may have a significant impact on the control of the external borders. 4. The national coordination centre shall attribute a single indicative impact level, ranging from \u2018low\u2019 and \u2018medium\u2019 to \u2018high\u2019, to each incident in the events layer of the national situational picture. All incidents shall be shared with the Agency. 5. The operational layer of the national situational picture shall consist of the following sub-layers: (a) a sub-layer on own assets, including military assets assisting a law enforcement mission, and operational areas, which contains information on the position, status and type of own assets and on the authorities involved. With regard to military assets assisting a law enforcement mission, the national coordination centre may decide, at the request of the national authority responsible for such assets, to restrict access to such information on a need-to-know basis; (b) a sub-layer on environmental information, which contains or gives access to information on terrain and weather conditions at the external borders of the Member State concerned. 6. The information on own assets in the operational layer shall be classified as RESTREINT UE/EU RESTRICTED. 7. The analysis layer of the national situational picture shall consist of the following sub-layers: (a) an information sub-layer, which contains key developments and indicators which are relevant for the purposes of this Regulation; (b) an analytical sub-layer, which includes analytical reports, risk rating trends, regional monitors and briefing notes which are relevant for the purposes of this Regulation; (c) an intelligence sub-layer, which contains analysed information which is relevant for the purposes of this Regulation and, in particular, for the attribution of the impact levels to the external border sections; (d) an imagery and geo-data sub-layer, which includes reference imagery, background maps, validation of analysed information and change analysis (Earth observation imagery), as well as change detection, geo-referenced data and external border permeability maps. 8. The information contained in the analysis layer and on environmental information in the operational layer of the national situational picture may be based on the information provided in the European situational picture and in the common pre-frontier intelligence picture. 9. The national coordination centres of neighbouring Member States shall share with each other, directly and in near-real-time, the situational picture of neighbouring external border sections relating to: (a) incidents and other significant events contained in the events layer; (b) tactical risk analysis reports as contained in the analysis layer. 10. The national coordination centres of neighbouring Member States may share with each other, directly and in near-real-time, the situational picture of neighbouring external border sections relating to the positions, status and type of own assets operating in the neighbouring external border sections as contained in the operational layer. Article 10 European situational picture 1. The Agency shall establish and maintain a European situational picture in order to provide the national coordination centres with effective, accurate and timely information and analysis. 2. The European situational picture shall be composed of information collected from the following sources: (a) national situational pictures, to the extent required by this Article; (b) the Agency; (c) the Commission, providing strategic information on border control, including shortcomings in the carrying-out of external border control; (d) Union delegations and offices; (e) other relevant Union bodies, offices and agencies and international organisations as referred to in Article 18; (f) other sources. 3. The events layer of the European situational picture shall include information relating to: (a) incidents and other events contained in the events layer of the national situational picture; (b) incidents and other events contained in the common pre-frontier intelligence picture; (c) incidents in the operational area of a joint operation, pilot project or rapid intervention coordinated by the Agency. 4. In the European situational picture, the Agency shall take into account the impact level that was assigned to a specific incident in the national situational picture by the national coordination centre. 5. The operational layer of the European situational picture shall consist of the following sub-layers: (a) a sub-layer on own assets, which contains information on the position, time, status and type of assets participating in the Agency joint operations, pilot projects and rapid interventions or at the disposal of the Agency, and the deployment plan, including the area of operation, patrol schedules and communication codes; (b) a sub-layer on operations, which contains information on the joint operations, pilot projects and rapid interventions coordinated by the Agency, including the mission statement, location, status, duration, information on the Member States and other actors involved, daily and weekly situational reports, statistical data and information packages for the media; (c) a sub-layer on environmental information, which includes information on terrain and weather conditions at the external borders. 6. The information on own assets in the operational layer of the European situational picture shall be classified as RESTREINT UE/EU RESTRICTED. 7. The analysis layer of the European situational picture shall be structured in the same manner as that of the national situational picture set out in Article 9(7). Article 11 Common pre-frontier intelligence picture 1. The Agency shall establish and maintain a common pre-frontier intelligence picture in order to provide the national coordination centres with effective, accurate and timely information and analysis on the pre-frontier area. 2. The common pre-frontier intelligence picture shall be composed of information collected from the following sources: (a) national coordination centres, including information and reports received from Member States' liaison officers via the competent national authorities; (b) Union delegations and offices; (c) the Agency, including information and reports provided by its liaison officers; (d) other relevant Union bodies, offices and agencies and international organisations as referred to in Article 18; (e) authorities of third countries, on the basis of bilateral or multilateral agreements and regional networks as referred to in Article 20, via the national coordination centres; (f) other sources. 3. The common pre-frontier intelligence picture may contain information which is relevant for air border surveillance and checks at external border crossing points. 4. The events, operational and analysis layers of the common pre-frontier intelligence picture shall be structured in the same manner as those of the European situational picture set out in Article 10. 5. The Agency shall assign a single indicative impact level to each incident in the events layer of the common pre-frontier intelligence picture. The Agency shall inform the national coordination centres of any incident in the pre-frontier area. Article 12 Common application of surveillance tools 1. The Agency shall coordinate the common application of surveillance tools in order to supply the national coordination centres and itself with surveillance information on the external borders and on the pre-frontier area on a regular, reliable and cost-efficient basis. 2. The Agency shall provide a national coordination centre, at its request, with information on the external borders of the requesting Member State and on the pre-frontier area which may be derived from: (a) selective monitoring of designated third-country ports and coasts which have been identified through risk analysis and information as being embarkation or transit points for vessels or other craft used for illegal immigration or cross-border crime; (b) tracking of vessels or other craft over high seas which are suspected of, or have been identified as, being used for illegal immigration or cross-border crime; (c) monitoring of designated areas in the maritime domain in order to detect, identify and track vessels and other craft being used for, or suspected of being used for, illegal immigration or cross-border crime; (d) environmental assessment of designated areas in the maritime domain and at the external land border in order to optimise monitoring and patrolling activities; (e) selective monitoring of designated pre-frontier areas at the external borders which have been identified through risk analysis and information as being potential departure or transit areas for illegal immigration or cross-border crime. 3. The Agency shall provide the information referred to in paragraph 1 by combining and analysing data which may be collected from the following systems, sensors and platforms: (a) ship reporting systems in accordance with their respective legal bases; (b) satellite imagery; (c) sensors mounted on any vehicle, vessel or other craft. 4. The Agency may refuse a request from a national coordination centre for technical, financial or operational reasons. The Agency shall notify the national coordination centre in due time of the reasons for such a refusal. 5. The Agency may use on its own initiative the surveillance tools referred to in paragraph 2 for collecting information which is relevant for the common pre-frontier intelligence picture. Article 13 Processing of personal data 1. Where the national situational picture is used for the processing of personal data, those data shall be processed in accordance with Directive 95/46/EC, Framework Decision 2008/977/JHA and the relevant national provisions on data protection. 2. The European situational picture and the common pre-frontier intelligence picture may be used only for the processing of personal data concerning ship identification numbers. Those data shall be processed in accordance with Article 11ca of Regulation (EC) No 2007/2004. They shall be processed only for the purposes of detecting, identifying and tracking vessels, as well as for the purposes referred to in Article 11c(3) of that Regulation. They shall automatically be deleted within seven days of receipt by the Agency or, where additional time is needed in order to track a vessel, within two months of receipt by the Agency. CHAPTER III Reaction capability Article 14 Determination of external border sections For the purposes of this Regulation, each Member State shall divide its external land and sea borders into border sections, and shall notify them to the Agency. Article 15 Attribution of impact levels to external border sections 1. Based on the Agency's risk analysis and in agreement with the Member State concerned, the Agency shall attribute the following impact levels to each of the external land and sea border sections of Member States or change such levels: (a) low impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have an insignificant impact on border security; (b) medium impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have a moderate impact on border security; (c) high impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have a significant impact on border security. 2. The national coordination centre shall regularly assess whether there is a need to change the impact level of any of the border sections by taking into account the information contained in the national situational picture. 3. The Agency shall visualise the impact levels attributed to the external borders in the European situational picture. Article 16 Reaction corresponding to impact levels 1. The Member States shall ensure that the surveillance activities carried out at the external border sections correspond to the attributed impact levels in the following manner: (a) where a low impact level is attributed to an external border section, the national authorities with a responsibility for external border surveillance shall organise regular surveillance on the basis of risk analysis and ensure that sufficient personnel and resources are being kept in the border area in readiness for tracking, identification and interception; (b) where a medium impact level is attributed to an external border section, the national authorities with a responsibility for external border surveillance shall, in addition to the measures taken under point (a), ensure that appropriate surveillance measures are being taken at that border section. When such surveillance measures are taken, the national coordination centre shall be notified accordingly. The national coordination centre shall coordinate any support given in accordance with Article 5(3); (c) where a high impact level is attributed to an external border section, the Member State concerned shall, in addition to the measures taken under point (b), ensure, through the national coordination centre, that the national authorities operating at that border section are given the necessary support and that reinforced surveillance measures are taken. That Member State may request support from the Agency subject to the conditions for initiating joint operations or rapid interventions, as laid down in Regulation (EC) No 2007/2004. 2. The national coordination centre shall regularly inform the Agency of the measures taken at national level pursuant to point (c) of paragraph 1. 3. Where a medium or high impact level is attributed to an external border section which is adjacent to the border section of another Member State or of a country with which agreements or regional networks, as referred to in Articles 19 and 20, are in place, the national coordination centre shall contact the national coordination centre of the neighbouring Member State or the competent authority of the neighbouring country and shall endeavour to coordinate the necessary cross-border measures. 4. Where a Member State submits a request in accordance with point (c) of paragraph 1, the Agency, when responding to that request, may support that Member State in particular by: (a) giving priority treatment to the common application of surveillance tools; (b) coordinating the deployment of European Border Guard Teams in accordance with Regulation (EC) No 2007/2004; (c) ensuring the deployment of technical equipment at the disposal of the Agency in accordance with Regulation (EC) No 2007/2004; (d) coordinating any additional support offered by other Member States. 5. The Agency shall, together with the Member State concerned, evaluate the attribution of impact levels and the corresponding measures taken at national and Union level in its risk analysis reports. TITLE III SPECIFIC AND FINAL PROVISIONS Article 17 Allocation of tasks to other authorities in the Member States 1. Member States may charge regional, local, functional or other authorities which are in a position to take operational decisions, with ensuring situational awareness and reaction capability in their respective areas of competence, including the tasks and competences referred to in points (c), (e) and (f) of Article 5(3). 2. The decision of Member States to allocate tasks in accordance with paragraph 1 shall not affect the national coordination centre in its ability to cooperate and exchange information with other national coordination centres and the Agency. 3. In pre-defined cases, as determined at national level, the national coordination centre may authorise an authority referred to in paragraph 1 to communicate and exchange information with the regional authorities or the national coordination centre of another Member State or the competent authorities of a third country on condition that such authority regularly informs its own national coordination centre of such communication and information exchange. Article 18 Cooperation of the Agency with third parties 1. The Agency shall make use of existing information, capabilities and systems available in other Union institutions, bodies, offices and agencies, and international organisations, within their respective legal frameworks. 2. In accordance with paragraph 1, the Agency shall cooperate in particular with the following Union institutions, bodies, offices and agencies, and international organisations: (a) European Police Office (Europol) in order to exchange information on cross-border crime to be included in the European situational picture; (b) the European Union Satellite Centre, the European Maritime Safety Agency and the European Fisheries Control Agency when providing the common application of surveillance tools; (c) the Commission, the European External Action Service and Union bodies, offices and agencies including the European Asylum Support Office, which may provide the Agency with information that is relevant for maintaining the European situational picture and the common pre-frontier intelligence picture; (d) international organisations which may provide the Agency with information relevant for maintaining the European situational picture and the common pre-frontier intelligence picture. 3. In accordance with paragraph 1, the Agency may cooperate with the Maritime Analysis and Operations Centre - Narcotics (MAOC-N) and the Centre de Coordination pour la lutte antidrogue en M\u00e9diterran\u00e9e (CeCLAD-M) in order to exchange information on cross-border crime to be included in the European situational picture. 4. Information between the Agency and the Union bodies, offices and agencies, and international organisations, referred to in paragraphs 2 and 3, shall be exchanged via the communication network referred to in Article 7 or other communication networks which fulfil the criteria of availability, confidentiality and integrity. 5. The cooperation between the Agency and the Union bodies, offices and agencies, and international organisations, referred to in paragraphs 2 and 3, shall be regulated as part of working arrangements in accordance with Regulation (EC) No 2007/2004 and the respective legal basis of the Union body, office or agency, or international organisation, concerned. As regards the handling of classified information, those arrangements shall provide that the Union body, office or agency or international organisation concerned comply with security rules and standards equivalent to those applied by the Agency. 6. The Union bodies, offices and agencies, and international organisations, referred to in paragraphs 2 and 3, shall use information received in the context of EUROSUR only within the limits of their legal framework and in compliance with fundamental rights, including data protection requirements. Article 19 Cooperation with Ireland and the United Kingdom 1. For the purposes of this Regulation, the exchange of information and the cooperation with Ireland and the United Kingdom may take place on the basis of bilateral or multilateral agreements between Ireland or the United Kingdom respectively and one or several neighbouring Member States or through regional networks based on those agreements. The national coordination centres of the Member States shall be the contact points for the exchange of information with the corresponding authorities of Ireland and the United Kingdom within EUROSUR. Once those agreements are concluded, they shall be notified to the Commission. 2. The agreements referred to in paragraph 1 shall be limited to the following exchange of information between the national coordination centre of a Member State and the corresponding authority of Ireland or the United Kingdom: (a) information contained in the national situational picture of a Member State to the extent transmitted to the Agency for the purposes of the European situational picture and the common pre-frontier intelligence picture; (b) information collected by Ireland and the United Kingdom which is relevant for the purposes of the European situational picture and the common pre-frontier intelligence picture; (c) information as referred to in Article 9(9). 3. Information provided in the context of EUROSUR by the Agency or by a Member State which is not party to an agreement as referred to in paragraph 1 shall not be shared with Ireland or the United Kingdom without the prior approval of the Agency or of that Member State. The Member States and the Agency shall be bound by the refusal to share that information with Ireland or the United Kingdom. 4. Onward transmission or other communication of information exchanged under this Article to third countries or to third parties shall be prohibited. 5. The agreements referred to in paragraph 1 shall include provisions on the financial costs arising from the participation of Ireland and the United Kingdom in the implementation of those agreements. Article 20 Cooperation with neighbouring third countries 1. For the purposes of this Regulation, Member States may exchange information and cooperate with one or several neighbouring third countries. Such exchange of information and such cooperation shall take place on the basis of bilateral or multilateral agreements or through regional networks established on the basis of those agreements. The national coordination centres of the Member States shall be the contact points for the exchange of information with neighbouring third countries. 2. Before any agreement referred to in paragraph 1 is concluded, the Member States concerned shall notify the agreement to the Commission, which shall verify that its provisions which are relevant for EUROSUR comply with this Regulation. Once the agreement is concluded, the Member State concerned shall notify it to the Commission which shall inform the European Parliament, the Council and the Agency thereof. 3. The agreements referred to in paragraph 1 shall comply with the relevant Union and international law on fundamental rights and on international protection, including the Charter of Fundamental Rights of the European Union and the Convention Relating to the Status of Refugees, in particular the principle of non-refoulement. 4. Any exchange of personal data with third countries in the framework of EUROSUR shall be strictly limited to what is absolutely necessary for the purposes of this Regulation. It shall be carried out in accordance with Directive 95/46/EC, Framework Decision 2008/977/JHA and the relevant national provisions on data protection. 5. Any exchange of information under paragraph 1, which provides a third country with information that could be used to identify persons or groups of persons whose request for access to international protection is under examination or who are under a serious risk of being subjected to torture, inhuman and degrading treatment or punishment or any other violation of fundamental rights, shall be prohibited. 6. Any exchange of information under paragraph 1 shall comply with the conditions of the bilateral and multilateral agreements concluded with neighbouring third countries. 7. Information provided in the context of EUROSUR by the Agency or by a Member State which is not party to an agreement as referred to in paragraph 1 shall not be shared with a third country under that agreement without the prior approval of the Agency or of that Member State. The Member States and the Agency shall be bound by the refusal to share that information with the third country concerned. 8. Onward transmission or other communication of information exchanged under this Article to other third countries or to third parties shall be prohibited. 9. Any exchange of information with third countries acquired via the common application of surveillance tools shall be subject to the laws and rules governing those tools as well as to the relevant provisions of Directive 95/46/EC, Regulation (EC) No 45/2001 and Framework Decision 2008/977/JHA. Article 21 Handbook 1. The Commission shall, in close cooperation with the Member States, the Agency and any other relevant Union body, office or agency, make available a practical handbook for the implementation and management of EUROSUR (\u2018Handbook\u2019). The Handbook shall provide technical and operational guidelines, recommendations and best practices, including on cooperation with third countries. The Commission shall adopt the Handbook in the form of a recommendation. 2. The Commission may decide, after consultation with Member States and the Agency, to classify parts of the Handbook as RESTREINT UE/EU RESTRICTED in compliance with the rules laid down in the Rules of Procedure of the Commission. Article 22 Monitoring and evaluation 1. For the purposes of this Regulation, the Agency and the Member States shall ensure that procedures are in place to monitor the technical and operational functioning of EUROSUR against the objectives of achieving an adequate situational awareness and reaction capability at the external borders and respect for fundamental rights, including the principle of non-refoulement. 2. The Agency shall submit a report to the European Parliament and to the Council on the functioning of EUROSUR by 1 December 2015 and every two years thereafter. 3. The Commission shall provide an overall evaluation of EUROSUR to the European Parliament and the Council by 1 December 2016 and every four years thereafter. That evaluation shall include an assessment of the results achieved against the objectives set, of the continuing validity of the underlying rationale, of the application of this Regulation in the Member States and by the Agency and of the compliance with and impact on fundamental rights. It shall also include a cost benefit evaluation. That evaluation shall be accompanied, where necessary, by appropriate proposals to amend this Regulation. 4. Member States shall provide the Agency with the information necessary to draft the report referred to in paragraph 2. The Agency shall provide the Commission with the information necessary to produce the evaluation referred to in paragraph 3. Article 23 Amendments to Regulation (EC) No 2007/2004 Regulation (EC) No 2007/2004 is hereby amended as follows: (1) in Article 2(1), point (i) is replaced by the following: \u2018(i) provide the necessary assistance for the development and operation of a European border surveillance system and, as appropriate, to the development of a common information-sharing environment, including interoperability of systems, in particular by establishing, maintaining and coordinating the EUROSUR framework in accordance with Regulation (EU) No 1052/2013 of the European Parliament and of the Council (16). (2) the following Article is inserted: \u2018Article 11ca Processing of personal data in the framework of EUROSUR The Agency may process personal data as set out in Article 13(2) of Regulation (EU) No 1052/2013, which shall be applied in accordance with the measures referred to in Article 11a of this Regulation. In particular, the processing of such data shall respect the principles of necessity and proportionality and the onward transmission or other communication of such personal data processed by the Agency to third countries shall be prohibited.\u2019. Article 24 Entry into force and applicability 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. This Regulation shall apply from 2 December 2013. 3. Bulgaria, Estonia, Greece, Spain, France, Croatia, Italy, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Portugal, Romania, Slovenia, Slovakia and Finland shall establish a national coordination centre in accordance with Article 5 as from 2 December 2013. The remaining Member States shall establish a national coordination centre in accordance with Article 5 as from 1 December 2014. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 22 October 2013. For the European Parliament The President M. SCHULZ For the Council The President V. LE\u0160KEVI\u010cIUS (1) Position of the European Parliament of 10 October 2013 (not yet published in the Official Journal) and decision of the Council of 22 October 2013. (2) Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 349, 25.11.2004, p. 1). (3) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (4) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (5) Council Framework Decision 2008/977/JHA of 27 November 2008 on the protection of personal data processed in the framework of police and judicial cooperation in criminal matters (OJ L 350, 30.12.2008, p. 60). (6) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (7) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (8) OJ L 176, 10.7.1999, p. 36. (9) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (10) OJ L 53, 27.2.2008, p. 52. (11) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (12) OJ L 160, 18.6.2011, p. 21. (13) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (14) Regulation (EC) No 562/2006 of the European Parliament and of the Council of 15 March 2006 establishing a Community Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 105, 13.4.2006, p. 1). (15) OJ L 308, 8.12.2000, p. 26. (16) Regulation (EU) No 1052/2013 of the European Parliament and of the Council of 22 October 2013 establishing the European Border Surveillance System (EUROSUR) (OJ L 295, 6.11.2013, p. 11).\u2019; ANNEX The following principles shall be taken into account when setting, operating and maintaining the different components of the EUROSUR framework: (a) Principle of communities of interest: the national coordination centres and the Agency shall form particular communities of interest for sharing information and for cooperation in the framework of EUROSUR. Communities of interest shall be used to organise different national coordination centres and the Agency to exchange information in pursuit of shared objectives, requirements and interests. (b) Principles of consistent management and of using existing structures: the Agency shall ensure consistency between the different components of the EUROSUR framework, including by providing guidance and support to the national coordination centres and promoting the interoperability of information and technology. To the extent possible, the EUROSUR framework shall make use of existing systems and capabilities, in order to optimise the use of the general budget of the Union and to avoid duplication. In this context, EUROSUR shall be established in full compatibility with CISE, thereby contributing to and benefitting from a coordinated and cost-efficient approach to cross-sectoral information exchange in the Union. (c) Principles of information sharing and of information assurance: information made available in the EUROSUR framework shall be available to all national coordination centres and the Agency, unless specific restrictions have been laid down or agreed. The national coordination centres shall ensure the availability, confidentiality and integrity of the information to be exchanged at national, European and international level. The Agency shall ensure the availability, confidentiality and integrity of the information to be exchanged at European and international level. (d) Principles of service-orientation and of standardisation: the different EUROSUR capabilities shall be implemented using a service-oriented approach. The Agency shall ensure that, to the extent possible, the EUROSUR framework is based on internationally agreed standards. (e) Principle of flexibility: organisation, information and technology shall be designed to enable the EUROSUR stakeholders to react to changing situations in a flexible and structured manner. Statement by the Council EUROSUR will contribute to improving the protection and the saving of lives of migrants. The Council recalls that search and rescue at sea is a competence of the Member States which they exercise in the framework of international conventions.", "summary": "European border surveillance system (Eurosur) European border surveillance system (Eurosur) To improve integrated border management and to prevent cross-border crime and illegal immigration, the European Union (EU) created the European border surveillance system (Eurosur). ACT Regulation (EU) No 1052/2013 of the European Parliament and of the Council of 22 October 2013 establishing the European border surveillance system (Eurosur). SUMMARY In October 2013, the EU adopted a regulation establishing the European border surveillance system (Eurosur). Multi-purpose system Eurosur is a multi-purpose system to prevent illegal immigration and cross-border crime at the external borders. It will also contribute to ensuring the protection and saving the lives of migrants trying to reach European shores. It provides a mechanism allowing border surveillance agencies to rapidly exchange information and work together. By means of national coordination centres, all EU countries\u2019 national authorities responsible for border surveillance (e.g. border guards, police, coastguard, navy, etc.) must coordinate their activities with those of other EU countries and the EU border agency, Frontex. Faster responses thanks to better information Eurosur follows an intelligence-driven approach, allowing national and EU agencies to better understand what is happening at external borders and to respond faster to new routes and methods used by criminal networks. Rapid reaction capability Eurosur enables EU countries to react faster not only to single incidents, but also to critical situations occurring at EU external borders. For this purpose, the external land and sea borders have been divided into \u2018border sections\u2019 and they have each been assigned a low, medium or high \u2018impact level\u2019. This allows hotspots at the external borders to be identified, with a standardised reaction at national level and at EU level, if required. Fundamental rights EU countries that have signed the Schengen Agreement and Frontex must fully respect fundamental rights, in particular the non-refoulement principle (which forbids a true victim of persecution being returned to their persecutor) and personal data protection. Entry into force As of December 2013, Eurosur was operational in the 19 EU countries that signed the Schengen Agreement that have southern and eastern external borders. The remaining 11 Schengen countries joined Eurosur on 1 December 2014. Denmark, Ireland and the United Kingdom (1) did not take part in the adoption of this regulation. However, it was agreed that Ireland and the United Kingdom (1) could cooperate with Eurosur by means of regional networks. Denmark has since decided to participate in Eurosur. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal 1052/2013 26.11.2013 - OJ L 295 of 6.11.2013 last update 22.04.2014(1) The United Kingdom withdraws from the European Union and becomes a third country (non-EU country) as of 1 February 2020."}
{"article": "29.6.2013 EN Official Journal of the European Union L 180/1 REGULATION (EU) No 603/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 June 2013 on the establishment of \u2027Eurodac\u2027 for the comparison of fingerprints for the effective application of Regulation (EU) No 604/2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes, and amending Regulation (EU) No 1077/2011 establishing a European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice (recast) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 78 (2)(e), 87(2)(a) and 88(2)(a) thereof, Having regard to the proposal from the European Commission Having regard to the opinion of the European Data Protection Supervisor (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) A number of substantive changes are to be made to Council Regulation (EC) No 2725/2000 of 11 December 2000 concerning the establishment of \u2027Eurodac\u2027 for the comparison of fingerprints for the effective application of the Dublin Convention (3) and to Council Regulation (EC) No 407/2002 of 28 February 2002 laying down certain rules to implement Regulation (EC) No 2725/2000 concerning the establishment of \"Eurodac\" for the comparison of fingerprints for the effective application of the Dublin Convention (4). In the interest of clarity, those Regulations should be recast. (2) A common policy on asylum, including a Common European Asylum System, is a constituent part of the European Union's objective of progressively establishing an area of freedom, security and justice open to those who, forced by circumstances, seek international protection in the Union. (3) The European Council of 4 November 2004 adopted The Hague Programme which set the objectives to be implemented in the area of freedom, security and justice in the period 2005-2010. The European Pact on Immigration and Asylum endorsed by the European Council of 15-16 October 2008 called for the completion of the establishment of a Common European Asylum System by creating a single procedure comprising common guarantees and a uniform status for refugees and for persons eligible for subsidiary protection. (4) For the purposes of applying Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person (5), it is necessary to establish the identity of applicants for international protection and of persons apprehended in connection with the unlawful crossing of the external borders of the Union. It is also desirable, in order effectively to apply Regulation (EU) No 604/2013, and in particular Article 18(1)(b) and (d) thereof, to allow each Member State to check whether a third-country national or stateless person found illegally staying on its territory has applied for international protection in another Member State. (5) Fingerprints constitute an important element in establishing the exact identity of such persons. It is necessary to set up a system for the comparison of their fingerprint data. (6) To that end, it is necessary to set up a system known as \u2027Eurodac\u2027, consisting of a Central System, which will operate a computerised central database of fingerprint data, as well as of the electronic means of transmission between the Member States and the Central System, hereinafter the \"Communication Infrastructure\". (7) The Hague Programme called for the improvement of access to existing data filing systems in the Union. In addition, The Stockholm Programme called for well targeted data collection and a development of information exchange and its tools that is driven by law enforcement needs. (8) It is essential in the fight against terrorist offences and other serious criminal offences for the law enforcement authorities to have the fullest and most up-to-date information if they are to perform their tasks. The information contained in Eurodac is necessary for the purposes of the prevention, detection or investigation of terrorist offences as referred to in Council Framework Decision 2002/475/JHA of 13 June 2002 on combating terrorism (6) or of other serious criminal offences as referred to in Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (7). Therefore, the data in Eurodac should be available, subject to the conditions set out in this Regulation, for comparison by the designated authorities of Member States and the European Police Office (Europol). (9) The powers granted to law enforcement authorities to access Eurodac should be without prejudice to the right of an applicant for international protection to have his or her application processed in due course in accordance with the relevant law. Furthermore, any subsequent follow-up after obtaining a \u2027hit\u2027 from Eurodac should also be without prejudice to that right. (10) The Commission outlines in its Communication to the Council and the European Parliament of 24 November 2005 on improved effectiveness, enhanced interoperability and synergies among European databases in the area of Justice and Home Affairs that authorities responsible for internal security could have access to Eurodac in well defined cases, when there is a substantiated suspicion that the perpetrator of a terrorist or other serious criminal offence has applied for international protection. In that Communication the Commission also found that the proportionality principle requires that Eurodac be queried for such purposes only if there is an overriding public security concern, that is, if the act committed by the criminal or terrorist to be identified is so reprehensible that it justifies querying a database that registers persons with a clean criminal record, and it concluded that the threshold for authorities responsible for internal security to query Eurodac must therefore always be significantly higher than the threshold for querying criminal databases. (11) Moreover, Europol plays a key role with respect to cooperation between Member States' authorities in the field of cross-border crime investigation in supporting Union-wide crime prevention, analyses and investigation. Consequently, Europol should also have access to Eurodac within the framework of its tasks and in accordance with Council Decision 2009/371/JHA of 6 April 2009 establishing the European Police Office (Europol) (8). (12) Requests for comparison of Eurodac data by Europol should be allowed only in specific cases, under specific circumstances and under strict conditions. (13) Since Eurodac was originally established to facilitate the application of the Dublin Convention, access to Eurodac for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences constitutes a change of the original purpose of Eurodac, which interferes with the fundamental right to respect for the private life of individuals whose personal data are processed in Eurodac. Any such interference must be in accordance with the law, which must be formulated with sufficient precision to allow individuals to adjust their conduct and it must protect individuals against arbitrariness and indicate with sufficient clarity the scope of discretion conferred on the competent authorities and the manner of its exercise. Any interference must be necessary in a democratic society to protect a legitimate and proportionate interest and proportionate to the legitimate objective it aims to achieve. (14) Even though the original purpose of the establishment of Eurodac did not require the facility of requesting comparisons of data with the database on the basis of a latent fingerprint, which is the dactyloscopic trace which may be found at a crime scene, such a facility is fundamental in the field of police cooperation. The possibility to compare a latent fingerprint with the fingerprint data which is stored in Eurodac in cases where there are reasonable grounds for believing that the perpetrator or victim may fall under one of the categories covered by this Regulation will provide the designated authorities of the Member States with a very valuable tool in preventing, detecting or investigating terrorist offences or other serious criminal offences, when for example the only evidence available at a crime scene are latent fingerprints. (15) This Regulation also lays down the conditions under which requests for comparison of fingerprint data with Eurodac data for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences should be allowed and the necessary safeguards to ensure the protection of the fundamental right to respect for the private life of individuals whose personal data are processed in Eurodac. The strictness of those conditions reflects the fact that the Eurodac database registers fingerprint data of persons who are not presumed to have committed a terrorist offence or other serious criminal offence. (16) With a view to ensuring equal treatment for all applicants and beneficiaries of international protection, as well as in order to ensure consistency with the current Union asylum acquis, in particular with Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted (9) and Regulation (EU) No 604/2013, it is appropriate to extend the scope of this Regulation in order to include applicants for subsidiary protection and persons eligible for subsidiary protection. (17) It is also necessary to require the Member States promptly to take and transmit the fingerprint data of every applicant for international protection and of every third-country national or stateless person who is apprehended in connection with the irregular crossing of an external border of a Member State, if they are at least 14 years of age. (18) It is necessary to lay down precise rules for the transmission of such fingerprint data to the Central System, the recording of such fingerprint data and of other relevant data in the Central System, their storage, their comparison with other fingerprint data, the transmission of the results of such comparison and the marking and erasure of the recorded data. Such rules may be different for, and should be specifically adapted to, the situation of different categories of third-country nationals or stateless persons. (19) Member States should ensure the transmission of fingerprint data of an appropriate quality for the purpose of comparison by means of the computerised fingerprint recognition system. All authorities with a right of access to Eurodac should invest in adequate training and in the necessary technological equipment. The authorities with a right of access to Eurodac should inform the European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice established by Regulation (EU) No 1077/2011 of the European Parliament and of the Council (10) (the \"Agency\") of specific difficulties encountered with regard to the quality of data, in order to resolve them. (20) The fact that it is temporarily or permanently impossible to take and/or to transmit fingerprint data, due to reasons such as insufficient quality of the data for appropriate comparison, technical problems, reasons linked to the protection of health or due to the data subject being unfit or unable to have his or her fingerprints taken owing to circumstances beyond his or her control, should not adversely affect the examination of or the decision on the application for international protection lodged by that person. (21) Hits obtained from Eurodac should be verified by a trained fingerprint expert in order to ensure the accurate determination of responsibility under Regulation (EU) No 604/2013 and the exact identification of the criminal suspect or victim of crime whose data might be stored in Eurodac. (22) Third-country nationals or stateless persons who have requested international protection in one Member State may have the option of requesting international protection in another Member State for many years to come. Therefore, the maximum period during which fingerprint data should be kept by the Central System should be of considerable length. Given that most third-country nationals or stateless persons who have stayed in the Union for several years will have obtained a settled status or even citizenship of a Member State after that period, a period of ten years should be considered a reasonable period for the storage of fingerprint data. (23) The storage period should be shorter in certain special situations where there is no need to keep fingerprint data for that length of time. Fingerprint data should be erased immediately once third-country nationals or stateless persons obtain citizenship of a Member State. (24) It is appropriate to store data relating to those data subjects whose fingerprints were initially recorded in Eurodac upon lodging their applications for international protection and who have been granted international protection in a Member State in order to allow data recorded upon lodging an application for international protection to be compared against them. (25) The Agency has been entrusted with the Commission's tasks relating to the operational management of Eurodac in accordance with this Regulation and with certain tasks relating to the Communication Infrastructure as from the date on which the Agency took up its responsibilities on 1 December 2012. The Agency should take up the tasks entrusted to it under this Regulation, and the relevant provisions of Regulation (EU) No 1077/2011 should be amended accordingly. In addition, Europol should have observer status at the meetings of the Management Board of the Agency when a question in relation to the application of this Regulation concerning access for consultation of Eurodac by designated authorities of Member States and by Europol for the purposes of the prevention, detection or investigation of terrorist offences or of other serious criminal offences is on the agenda. Europol should be able to appoint a representative to the Eurodac Advisory Group of the Agency. (26) The Staff Regulations of Officials of the European Union (Staff Regulations of Officials) and the Conditions of Employment of Other Servants of the European Union (\u2027Conditions of Employment\u2027), laid down in Regulation (EEC, Euratom, ECSC) No 259/68 of the Council (11) (together referred to as the \u2027Staff Regulations\u2027) should apply to all staff working in the Agency on matters pertaining to this Regulation. (27) It is necessary to lay down clearly the respective responsibilities of the Commission and the Agency, in respect of the Central System and the Communication Infrastructure, and of the Member States, as regards data processing, data security, access to, and correction of, recorded data. (28) It is necessary to designate the competent authorities of the Member States as well as the National Access Point through which the requests for comparison with Eurodac data are made and to keep a list of the operating units within the designated authorities that are authorised to request such comparison for the specific purposes of the prevention, detection or investigation of terrorist offences or of other serious criminal offences. (29) Requests for comparison with data stored in the Central System should be made by the operating units within the designated authorities to the National Access Point, through the verifying authority and should be reasoned. The operating units within the designated authorities that are authorised to request comparisons with Eurodac data should not act as a verifying authority. The verifying authorities should act independently of the designated authorities and should be responsible for ensuring, in an independent manner, strict compliance with the conditions for access as established in this Regulation. The verifying authorities should then forward the request, without forwarding the reasons for it, for comparison through the National Access Point to the Central System following verification that all conditions for access are fulfilled. In exceptional cases of urgency where early access is necessary to respond to a specific and actual threat related to terrorist offences or other serious criminal offences, the verifying authority should process the request immediately and only carry out the verification afterwards. (30) The designated authority and the verifying authority may be part of the same organisation, if permitted under national law, but the verifying authority should act independently when performing its tasks under this Regulation. (31) For the purposes of protection of personal data, and to exclude systematic comparisons which should be forbidden, the processing of Eurodac data should only take place in specific cases and when it is necessary for the purposes of preventing, detecting or investigating terrorist offences or other serious criminal offences. A specific case exists in particular when the request for comparison is connected to a specific and concrete situation or to a specific and concrete danger associated with a terrorist offence or other serious criminal offence, or to specific persons in respect of whom there are serious grounds for believing that they will commit or have committed any such offence. A specific case also exists when the request for comparison is connected to a person who is the victim of a terrorist offence or other serious criminal offence. The designated authorities and Europol should thus only request a comparison with Eurodac when they have reasonable grounds to believe that such a comparison will provide information that will substantially assist them in preventing, detecting or investigating a terrorist offence or other serious criminal offence. (32) In addition, access should be allowed only on condition that comparisons with the national fingerprint databases of the Member State and with the automated fingerprinting identification systems of all other Member States under Council Decision 2008/615/JHA of 23 June 2008 on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime (12) did not lead to the establishment of the identity of the data subject. That condition requires the requesting Member State to conduct comparisons with the automated fingerprinting identification systems of all other Member States under Decision 2008/615/JHA which are technically available, unless that Member State can justify that there are reasonable grounds to believe that it would not lead to the establishment of the identity of the data subject. Such reasonable grounds exist in particular where the specific case does not present any operational or investigative link to a given Member State. That condition requires prior legal and technical implementation of Decision 2008/615/JHA by the requesting Member State in the area of fingerprint data, as it should not be permitted to conduct a Eurodac check for law enforcement purposes where those above steps have not been first taken. (33) Prior to searching Eurodac, designated authorities should also, provided that the conditions for a comparison are met, consult the Visa Information System under Council Decision 2008/633/JHA of 23 June 2008 concerning access for consultation of the Visa Information System (VIS) by designated authorities of Member States and by Europol for the purposes of the prevention, detection and investigation of terrorist offences and of other serious criminal offences (13). (34) For the purpose of efficient comparison and exchange of personal data, Member States should fully implement and make use of the existing international agreements as well as of Union law concerning the exchange of personal data already in force, in particular of Decision 2008/615/JHA. (35) The best interests of the child should be a primary consideration for Member States when applying this Regulation. Where the requesting Member State establishes that Eurodac data pertain to a minor, these data may only be used for law enforcement purposes by the requesting Member State in accordance with that State's laws applicable to minors and in accordance with the obligation to give primary consideration to the best interests of the child. (36) While the non-contractual liability of the Union in connection with the operation of the Eurodac system will be governed by the relevant provisions of the Treaty on the Functioning of the European Union (TFEU), it is necessary to lay down specific rules for the non-contractual liability of the Member States in connection with the operation of the system. (37) Since the objective of this Regulation, namely the creation of a system for the comparison of fingerprint data to assist the implementation of Union asylum policy, cannot, by its very nature, be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (38) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (14) applies to the processing of personal data by the Member States carried out in application of this Regulation unless such processing is carried out by the designated or verifying authorities of the Member States for the purposes of the prevention, detection or investigation of terrorist offences or of other serious criminal offences. (39) The processing of personal data by the authorities of the Member States for the purposes of the prevention, detection or investigation of terrorist offences or of other serious criminal offences pursuant to this Regulation should be subject to a standard of protection of personal data under their national law which complies with Council Framework Decision 2008/977/JHA of 27 November 2008 on the protection of personal data processed in the framework of police and judicial co-operation in criminal matters (15). (40) The principles set out in Directive 95/46/EC regarding the protection of the rights and freedoms of individuals, notably their right to privacy, with regard to the processing of personal data should be supplemented or clarified, in particular as far as certain sectors are concerned. (41) Transfers of personal data obtained by a Member State or Europol pursuant to this Regulation from the Central System to any third country or international organisation or private entity established in or outside the Union should be prohibited, in order to ensure the right to asylum and to safeguard applicants for international protection from having their data disclosed to a third country. This implies that Member States should not transfer information obtained from the Central System concerning: the Member State(s) of origin; the place and date of application for international protection; the reference number used by the Member State of origin; the date on which the fingerprints were taken as well as the date on which the Member State(s) transmitted the data to Eurodac; the operator user ID; and any information relating to any transfer of the data subject under Regulation (EU) No 604/2013. That prohibition should be without prejudice to the right of Member States to transfer such data to third countries to which Regulation (EU) No 604/2013 applies, in order to ensure that Member States have the possibility of cooperating with such third countries for the purposes of this Regulation. (42) National supervisory authorities should monitor the lawfulness of the processing of personal data by the Member States, and the supervisory authority set up by Decision 2009/371/JHA should monitor the lawfulness of data processing activities performed by Europol. (43) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (16), and in particular Articles 21 and 22 thereof concerning confidentiality and security of processing, applies to the processing of personal data by Union institutions, bodies, offices and agencies carried out in application of this Regulation. However, certain points should be clarified in respect of the responsibility for the processing of data and of the supervision of data protection, bearing in mind that data protection is a key factor in the successful operation of Eurodac and that data security, high technical quality and lawfulness of consultations are essential to ensure the smooth and proper functioning of Eurodac as well as to facilitate the application of Regulation (EU) No 604/2013. (44) The data subject should be informed of the purpose for which his or her data will be processed within Eurodac, including a description of the aims of Regulation (EU) No 604/2013, and of the use to which law enforcement authorities may put his or her data. (45) It is appropriate that national supervisory authorities monitor the lawfulness of the processing of personal data by the Member States, whilst the European Data Protection Supervisor, as referred to in Regulation (EC) No 45/2001, should monitor the activities of the Union institutions, bodies, offices and agencies in relation to the processing of personal data carried out in application of this Regulation. (46) Member States, the European Parliament, the Council and the Commission should ensure that the national and European supervisory authorities are able to supervise the use of and access to Eurodac data adequately. (47) It is appropriate to monitor and evaluate the performance of Eurodac at regular intervals, including in terms of whether law enforcement access has led to indirect discrimination against applicants for international protection, as raised in the Commission's evaluation of the compliance of this Regulation with the Charter of Fundamental Rights of the European Union (\u2027the Charter\u2027). The Agency should submit an annual report on the activities of the Central System to the European Parliament and to the Council. (48) Member States should provide for a system of effective, proportionate and dissuasive penalties to sanction the processing of data entered in the Central System contrary to the purpose of Eurodac. (49) It is necessary that Member States be informed of the status of particular asylum procedures, with a view to facilitating the adequate application of Regulation (EU) No 604/2013. (50) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter. In particular, this Regulation seeks to ensure full respect for the protection of personal data and for the right to seek international protection, and to promote the application of Articles 8 and 18 of the Charter. This Regulation should therefore be applied accordingly. (51) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (52) In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the Area of Freedom, Security and Justice, annexed to the TEU and to the TFEU, the United Kingdom has notified its wish to take part in the adoption and application of this Regulation. (53) In accordance with Article 1 and 2 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the Area of Freedom, Security and Justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, Ireland is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (54) It is appropriate to restrict the territorial scope of this Regulation so as to align it on the territorial scope of Regulation (EU) No 604/2013, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Purpose of \"Eurodac\" 1. A system known as \"Eurodac\" is hereby established, the purpose of which shall be to assist in determining which Member State is to be responsible pursuant to Regulation (EU) No 604/2013 for examining an application for international protection lodged in a Member State by a third-country national or a stateless person, and otherwise to facilitate the application of Regulation (EU) No 604/2013 under the conditions set out in this Regulation. 2. This Regulation also lays down the conditions under which Member States' designated authorities and the European Police Office (Europol) may request the comparison of fingerprint data with those stored in the Central System for law enforcement purposes. 3. Without prejudice to the processing of data intended for Eurodac by the Member State of origin in databases set up under the latter's national law, fingerprint data and other personal data may be processed in Eurodac only for the purposes set out in this Regulation and Article 34(1) of Regulation (EU) No 604/2013. Article 2 Definitions 1. For the purposes of this Regulation: (a) \u2027applicant for international protection\u2027 means a third-country national or a stateless person who has made an application for international protection as defined in Article 2(h) of Directive 2011/95/EU in respect of which a final decision has not yet been taken; (b) \u2027Member State of origin\u2027 means: (i) in relation to a person covered by Article 9(1), the Member State which transmits the personal data to the Central System and receives the results of the comparison; (ii) in relation to a person covered by Article 14(1), the Member State which transmits the personal data to the Central System; (iii) in relation to a person covered by Article 17(1), the Member State which transmits the personal data to the Central System and receives the results of the comparison; (c) \u2027beneficiary of international protection\u2027 means a third-country national or a stateless person who has been granted international protection as defined in Article 2(a) of Directive 2011/95/EU; (d) \u2027hit\u2027 means the existence of a match or matches established by the Central System by comparison between fingerprint data recorded in the computerised central database and those transmitted by a Member State with regard to a person, without prejudice to the requirement that Member States shall immediately check the results of the comparison pursuant to Article 25(4); (e) \u2027National Access Point\u2027 means the designated national system which communicates with the Central System; (f) \u2027Agency\u2027 means the Agency established by Regulation (EU) No 1077/2011; (g) \u2027Europol\u2027 means the European Police Office established by Decision 2009/371/JHA; (h) \u2027Eurodac data\u2027 means all data stored in the Central System in accordance with Article 11 and Article 14(2); (i) \u2027law enforcement\u2027 means the prevention, detection or investigation of terrorist offences or of other serious criminal offences; (j) \u2027terrorist offences\u2027 means the offences under national law which correspond or are equivalent to those referred to in Articles 1 to 4 of Framework Decision 2002/475/JHA; (k) \u2027serious criminal offences\u2027 means the forms of crime which correspond or are equivalent to those referred to in Article 2(2) of Framework Decision 2002/584/JHA, if they are punishable under national law by a custodial sentence or a detention order for a maximum period of at least three years; (l) \u2027fingerprint data\u2027 means the data relating to fingerprints of all or at least the index fingers, and if those are missing, the prints of all other fingers of a person, or a latent fingerprint. 2. The terms defined in Article 2 of Directive 95/46/EC shall have the same meaning in this Regulation in so far as personal data are processed by the authorities of the Member States for the purposes laid down in Article 1(1) of this Regulation. 3. Unless stated otherwise, the terms defined in Article 2 of Regulation (EU) No 604/2013 shall have the same meaning in this Regulation. 4. The terms defined in Article 2 of Framework Decision 2008/977/JHA shall have the same meaning in this Regulation in so far as personal data are processed by the authorities of the Member States for the purposes laid down in Article 1(2) of this Regulation. Article 3 System architecture and basic principles 1. Eurodac shall consist of: (a) a computerised central fingerprint database (\"Central System\") composed of: (i) a Central Unit, (ii) a Business Continuity Plan and System; (b) a communication infrastructure between the Central System and Member States that provides an encrypted virtual network dedicated to Eurodac data (\"Communication Infrastructure\"). 2. Each Member State shall have a single National Access Point. 3. Data on persons covered by Articles 9(1), 14(1) and 17(1) which are processed in the Central System shall be processed on behalf of the Member State of origin under the conditions set out in this Regulation and separated by appropriate technical means. 4. The rules governing Eurodac shall also apply to operations carried out by the Member States as from the transmission of data to the Central System until use is made of the results of the comparison. 5. The procedure for taking fingerprints shall be determined and applied in accordance with the national practice of the Member State concerned and in accordance with the safeguards laid down in the Charter of Fundamental Rights of the European Union, in the Convention for the Protection of Human Rights and Fundamental Freedoms and in the United Nations Convention on the Rights of the Child. Article 4 Operational management 1. The Agency shall be responsible for the operational management of Eurodac. The operational management of Eurodac shall consist of all the tasks necessary to keep Eurodac functioning 24 hours a day, 7 days a week in accordance with this Regulation, in particular the maintenance work and technical developments necessary to ensure that the system functions at a satisfactory level of operational quality, in particular as regards the time required for interrogation of the Central System. A Business Continuity Plan and System shall be developed taking into account maintenance needs and unforeseen downtime of the system, including the impact of business continuity measures on data protection and security. The Agency shall ensure, in cooperation with the Member States, that at all times the best available and most secure technology and techniques, subject to a cost-benefit analysis, are used for the Central System. 2. The Agency shall be responsible for the following tasks relating to the Communication Infrastructure: (a) supervision; (b) security; (c) the coordination of relations between the Member States and the provider. 3. The Commission shall be responsible for all tasks relating to the Communication Infrastructure other than those referred to in paragraph 2, in particular: (a) the implementation of the budget; (b) acquisition and renewal; (c) contractual matters. 4. Without prejudice to Article 17 of the Staff Regulations, the Agency shall apply appropriate rules of professional secrecy or other equivalent duties of confidentiality to all its staff required to work with Eurodac data. This obligation shall also apply after such staff leave office or employment or after the termination of their duties. Article 5 Member States' designated authorities for law enforcement purposes 1. For the purposes laid down in Article 1(2), Member States shall designate the authorities that are authorised to request comparisons with Eurodac data pursuant to this Regulation. Designated authorities shall be authorities of the Member States which are responsible for the prevention, detection or investigation of terrorist offences or of other serious criminal offences. Designated authorities shall not include agencies or units exclusively responsible for intelligence relating to national security. 2. Each Member State shall keep a list of the designated authorities. 3. Each Member State shall keep a list of the operating units within the designated authorities that are authorised to request comparisons with Eurodac data through the National Access Point. Article 6 Member States' verifying authorities for law enforcement purposes 1. For the purposes laid down in Article 1(2), each Member State shall designate a single national authority or a unit of such an authority to act as its verifying authority. The verifying authority shall be an authority of the Member State which is responsible for the prevention, detection or investigation of terrorist offences or of other serious criminal offences. The designated authority and the verifying authority may be part of the same organisation, if permitted under national law, but the verifying authority shall act independently when performing its tasks under this Regulation. The verifying authority shall be separate from the operating units referred to in Article 5(3) and shall not receive instructions from them as regards the outcome of the verification. Member States may designate more than one verifying authority to reflect their organisational and administrative structures, in accordance with their constitutional or legal requirements. 2. The verifying authority shall ensure that the conditions for requesting comparisons of fingerprints with Eurodac data are fulfilled. Only duly empowered staff of the verifying authority shall be authorised to receive and transmit a request for access to Eurodac in accordance with Article 19. Only the verifying authority shall be authorised to forward requests for comparison of fingerprints to the National Access Point. Article 7 Europol 1. For the purposes laid down in Article 1(2), Europol shall designate a specialised unit with duly empowered Europol officials to act as its verifying authority, which shall act independently of the designated authority referred to in paragraph 2 of this Article when performing its tasks under this Regulation and shall not receive instructions from the designated authority as regards the outcome of the verification. The unit shall ensure that the conditions for requesting comparisons of fingerprints with Eurodac data are fulfilled. Europol shall designate in agreement with any Member State the National Access Point of that Member State which shall communicate its requests for comparison of fingerprint data to the Central System. 2. For the purposes laid down in Article 1(2), Europol shall designate an operating unit that is authorised to request comparisons with Eurodac data through its designated National Access Point. The designated authority shall be an operating unit of Europol which is competent to collect, store, process, analyse and exchange information to support and strengthen action by Member States in preventing, detecting or investigating terrorist offences or other serious criminal offences falling within Europol's mandate. Article 8 Statistics 1. The Agency shall draw up statistics on the work of the Central System every quarter, indicating in particular: (a) the number of data sets transmitted on persons referred to in Articles 9(1), 14(1) and 17(1); (b) the number of hits for applicants for international protection who have lodged an application for international protection in another Member State; (c) the number of hits for persons referred to in Article 14(1) who have subsequently lodged an application for international protection; (d) the number of hits for persons referred to in Article 17(1) who had previously lodged an application for international protection in another Member State; (e) the number of fingerprint data which the Central System had to request more than once from the Member States of origin because the fingerprint data originally transmitted did not lend themselves to comparison using the computerised fingerprint recognition system; (f) the number of data sets marked, unmarked, blocked and unblocked in accordance with Article 18(1) and (3); (g) the number of hits for persons referred to in Article 18(1) for whom hits have been recorded under points (b) and (d) of this Article; (h) the number of requests and hits referred to in Article 20(1); (i) the number of requests and hits referred to in Article 21(1). 2. At the end of each year, statistical data shall be established in the form of a compilation of the quarterly statistics for that year, including an indication of the number of persons for whom hits have been recorded under paragraph 1(b), (c) and (d). The statistics shall contain a breakdown of data for each Member State. The results shall be made public. CHAPTER II APPLICANTS FOR INTERNATIONAL PROTECTION Article 9 Collection, transmission and comparison of fingerprints 1. Each Member State shall promptly take the fingerprints of all fingers of every applicant for international protection of at least 14 years of age and shall, as soon as possible and no later than 72 hours after the lodging of his or her application for international protection, as defined by Article 20(2) of Regulation (EU) No 604/2013, transmit them together with the data referred to in Article 11(b) to (g) of this Regulation to the Central System. Non-compliance with the 72-hour time-limit shall not relieve Member States of the obligation to take and transmit the fingerprints to the Central System. Where the condition of the fingertips does not allow the taking of the fingerprints of a quality ensuring appropriate comparison under Article 25, the Member State of origin shall retake the fingerprints of the applicant and resend them as soon as possible and no later than 48 hours after they have been successfully retaken. 2. By way of derogation from paragraph 1, where it is not possible to take the fingerprints of an applicant for international protection on account of measures taken to ensure his or her health or the protection of public health, Member States shall take and send such fingerprints as soon as possible and no later than 48 hours after those health grounds no longer prevail. In the event of serious technical problems, Member States may extend the 72-hour time-limit in paragraph 1 by a maximum of a further 48 hours in order to carry out their national continuity plans. 3. Fingerprint data within the meaning of Article 11(a) transmitted by any Member State, with the exception of those transmitted in accordance with Article 10(b), shall be compared automatically with the fingerprint data transmitted by other Member States and already stored in the Central System. 4. The Central System shall ensure, at the request of a Member State, that the comparison referred to in paragraph 3 covers the fingerprint data previously transmitted by that Member State, in addition to the data from other Member States. 5. The Central System shall automatically transmit the hit or the negative result of the comparison to the Member State of origin. Where there is a hit, it shall transmit for all data sets corresponding to the hit the data referred to in Article 11(a) to (k) along with, where appropriate, the mark referred to in Article 18(1). Article 10 Information on the status of the data subject The following information shall be sent to the Central System in order to be stored in accordance with Article 12 for the purpose of transmission under Article 9(5): (a) when an applicant for international protection or another person as referred to in Article 18(1)(d) of Regulation (EU) No 604/2013 arrives in the Member State responsible following a transfer pursuant to a decision acceding to a take back request as referred to in Article 25 thereof, the Member State responsible shall update its data set recorded in conformity with Article 11 of this Regulation relating to the person concerned by adding his or her date of arrival; (b) when an applicant for international protection arrives in the Member State responsible following a transfer pursuant to a decision acceding to a take charge request according to Article 22 of Regulation (EU) No 604/2013, the Member State responsible shall send a data set recorded in conformity with Article 11 of this Regulation relating to the person concerned and shall include his or her date of arrival; (c) as soon as the Member State of origin establishes that the person concerned whose data was recorded in Eurodac in accordance with Article 11 of this Regulation has left the territory of the Member States, it shall update its data set recorded in conformity with Article 11 of this Regulation relating to the person concerned by adding the date when that person left the territory, in order to facilitate the application of Articles 19(2) and 20(5) of Regulation (EU) No 604/2013; (d) as soon as the Member State of origin ensures that the person concerned whose data was recorded in Eurodac in accordance with Article 11 of this Regulation has left the territory of the Member States in compliance with a return decision or removal order issued following the withdrawal or rejection of the application for international protection as provided for in Article 19(3) of Regulation (EU) No 604/2013, it shall update its data set recorded in conformity with Article 11 of this Regulation relating to the person concerned by adding the date of his or her removal or when he or she left the territory; (e) the Member State which becomes responsible in accordance with Article 17(1) of Regulation (EU) No 604/2013 shall update its data set recorded in conformity with Article 11 of this Regulation relating to the applicant for international protection by adding the date when the decision to examine the application was taken. Article 11 Recording of data Only the following data shall be recorded in the Central System: (a) fingerprint data; (b) Member State of origin, place and date of the application for international protection; in the cases referred to in Article 10(b), the date of application shall be the one entered by the Member State who transferred the applicant; (c) sex; (d) reference number used by the Member State of origin; (e) date on which the fingerprints were taken; (f) date on which the data were transmitted to the Central System; (g) operator user ID; (h) where applicable in accordance with Article 10(a) or (b), the date of the arrival of the person concerned after a successful transfer; (i) where applicable in accordance with Article 10(c), the date when the person concerned left the territory of the Member States; (j) where applicable in accordance with Article 10(d), the date when the person concerned left or was removed from the territory of the Member States; (k) where applicable in accordance with Article 10(e), the date when the decision to examine the application was taken. Article 12 Data storage 1. Each set of data, as referred to in Article 11, shall be stored in the Central System for ten years from the date on which the fingerprints were taken. 2. Upon expiry of the period referred to in paragraph 1, the Central System shall automatically erase the data from the Central System. Article 13 Advance data erasure 1. Data relating to a person who has acquired citizenship of any Member State before expiry of the period referred to in Article 12(1) shall be erased from the Central System in accordance with Article 27(4) as soon as the Member State of origin becomes aware that the person concerned has acquired such citizenship. 2. The Central System shall, as soon as possible and no later than after 72 hours, inform all Member States of origin of the erasure of data in accordance with paragraph 1 by another Member State of origin having produced a hit with data which they transmitted relating to persons referred to in Article 9(1) or 14(1). CHAPTER III THIRD-COUNTRY NATIONALS OR STATELESS PERSONS APPREHENDED IN CONNECTION WITH THE IRREGULAR CROSSING OF AN EXTERNAL BORDER Article 14 Collection and transmission of fingerprint data 1. Each Member State shall promptly take the fingerprints of all fingers of every third-country national or stateless person of at least 14 years of age who is apprehended by the competent control authorities in connection with the irregular crossing by land, sea or air of the border of that Member State having come from a third country and who is not turned back or who remains physically on the territory of the Member States and who is not kept in custody, confinement or detention during the entirety of the period between apprehension and removal on the basis of the decision to turn him or her back. 2. The Member State concerned shall, as soon as possible and no later than 72 hours after the date of apprehension, transmit to the Central System the following data in relation to any third-country national or stateless person, as referred to in paragraph 1, who is not turned back: (a) fingerprint data; (b) Member State of origin, place and date of the apprehension; (c) sex; (d) reference number used by the Member State of origin; (e) date on which the fingerprints were taken; (f) date on which the data were transmitted to the Central System; (g) operator user ID. 3. By way of derogation from paragraph 2, the data specified in paragraph 2 relating to persons apprehended as described in paragraph 1 who remain physically on the territory of the Member States but are kept in custody, confinement or detention upon their apprehension for a period exceeding 72 hours shall be transmitted before their release from custody, confinement or detention. 4. Non-compliance with the 72-hour time-limit referred to in paragraph 2 of this Article shall not relieve Member States of the obligation to take and transmit the fingerprints to the Central System. Where the condition of the fingertips does not allow the taking of fingerprints of a quality ensuring appropriate comparison under Article 25, the Member State of origin shall retake the fingerprints of persons apprehended as described in paragraph 1 of this Article, and resend them as soon as possible and no later than 48 hours after they have been successfully retaken. 5. By way of derogation from paragraph 1, where it is not possible to take the fingerprints of the apprehended person on account of measures taken to ensure his or her health or the protection of public health, the Member State concerned shall take and send such fingerprints as soon as possible and no later than 48 hours after those health grounds no longer prevail. In the event of serious technical problems, Member States may extend the 72-hour time-limit in paragraph 2 by a maximum of a further 48 hours in order to carry out their national continuity plans. Article 15 Recording of data 1. The data referred to in Article 14(2) shall be recorded in the Central System. Without prejudice to Article 8, data transmitted to the Central System pursuant to Article 14(2) shall be recorded solely for the purposes of comparison with data on applicants for international protection subsequently transmitted to the Central System and for the purposes laid down in Article 1(2). The Central System shall not compare data transmitted to it pursuant to Article 14(2) with any data previously recorded in the Central System, or with data subsequently transmitted to the Central System pursuant to Article 14(2). 2. As regards the comparison of data on applicants for international protection subsequently transmitted to the Central System with the data referred to in paragraph 1, the procedures provided for in Article 9(3) and (5) and in Article 25(4) shall apply. Article 16 Storage of data 1. Each set of data relating to a third-country national or stateless person as referred to in Article 14(1) shall be stored in the Central System for 18 months from the date on which his or her fingerprints were taken. Upon expiry of that period, the Central System shall automatically erase such data. 2. The data relating to a third-country national or stateless person as referred to in Article 14(1) shall be erased from the Central System in accordance with Article 28(3) as soon as the Member State of origin becomes aware of one of the following circumstances before the 18 month period referred to in paragraph 1 of this Article has expired: (a) the third-country national or stateless person has been issued with a residence document; (b) the third-country national or stateless person has left the territory of the Member States; (c) the third-country national or stateless person has acquired the citizenship of any Member State. 3. The Central System shall, as soon as possible and no later than after 72 hours, inform all Member States of origin of the erasure of data for the reason specified in paragraph 2(a) or (b) of this Article by another Member State of origin having produced a hit with data which they transmitted relating to persons referred to in Article 14(1). 4. The Central System shall, as soon as possible and no later than after 72 hours, inform all Member States of origin of the erasure of data for the reason specified in paragraph 2(c) of this Article by another Member State of origin having produced a hit with data which they transmitted relating to persons referred to in Article 9(1) or 14(1). CHAPTER IV THIRD-COUNTRY NATIONALS OR STATELESS PERSONS FOUND ILLEGALLY STAYING IN A MEMBER STATE Article 17 Comparison of fingerprint data 1. With a view to checking whether a third-country national or a stateless person found illegally staying within its territory has previously lodged an application for international protection in another Member State, a Member State may transmit to the Central System any fingerprint data relating to fingerprints which it may have taken of any such third-country national or stateless person of at least 14 years of age together with the reference number used by that Member State. As a general rule there are grounds for checking whether the third-country national or stateless person has previously lodged an application for international protection in another Member State where: (a) the third-country national or stateless person declares that he or she has lodged an application for international protection but without indicating the Member State in which he or she lodged the application; (b) the third-country national or stateless person does not request international protection but objects to being returned to his or her country of origin by claiming that he or she would be in danger, or (c) the third-country national or stateless person otherwise seeks to prevent his or her removal by refusing to cooperate in establishing his or her identity, in particular by showing no, or false, identity papers. 2. Where Member States take part in the procedure referred to in paragraph 1, they shall transmit to the Central System the fingerprint data relating to all or at least the index fingers and, if those are missing, the prints of all the other fingers, of third-country nationals or stateless persons referred to in paragraph 1. 3. The fingerprint data of a third-country national or a stateless person as referred to in paragraph 1 shall be transmitted to the Central System solely for the purpose of comparison with the fingerprint data of applicants for international protection transmitted by other Member States and already recorded in the Central System. The fingerprint data of such a third-country national or a stateless person shall not be recorded in the Central System, nor shall they be compared with the data transmitted to the Central System pursuant to Article 14(2). 4. Once the results of the comparison of fingerprint data have been transmitted to the Member State of origin, the record of the search shall be kept by the Central System only for the purposes of Article 28. Other than for those purposes, no other record of the search may be stored either by Member States or by the Central System. 5. As regards the comparison of fingerprint data transmitted under this Article with the fingerprint data of applicants for international protection transmitted by other Member States which have already been stored in the Central System, the procedures provided for in Article 9(3) and (5) and in Article 25(4) shall apply. CHAPTER V BENEFICIARIES OF INTERNATIONAL PROTECTION Article 18 Marking of data 1. For the purposes laid down in Article 1(1), the Member State of origin which granted international protection to an applicant for international protection whose data were previously recorded in the Central System pursuant to Article 11 shall mark the relevant data in conformity with the requirements for electronic communication with the Central System established by the Agency. That mark shall be stored in the Central System in accordance with Article 12 for the purpose of transmission under Article 9(5). The Central System shall inform all Member States of origin of the marking of data by another Member State of origin having produced a hit with data which they transmitted relating to persons referred to in Article 9(1) or 14(1). Those Member States of origin shall also mark the corresponding data sets. 2. The data of beneficiaries of international protection stored in the Central System and marked pursuant to paragraph 1 of this Article shall be made available for comparison for the purposes laid down in Article 1(2) for a period of three years after the date on which the data subject was granted international protection. Where there is a hit, the Central System shall transmit the data referred to in Article 11(a) to (k) for all the data sets corresponding to the hit. The Central System shall not transmit the mark referred to in paragraph 1 of this Article. Upon the expiry of the period of three years, the Central System shall automatically block such data from being transmitted in the event of a request for comparison for the purposes laid down in Article 1(2), whilst leaving those data available for comparison for the purposes laid down in Article 1(1) until the point of their erasure. Blocked data shall not be transmitted, and the Central System shall return a negative result to the requesting Member State in the event of a hit. 3. The Member State of origin shall unmark or unblock data concerning a third-country national or stateless person whose data were previously marked or blocked in accordance with paragraphs 1 or 2 of this Article if his or her status is revoked or ended or the renewal of his or her status is refused under Articles 14 or 19 of Directive 2011/95/EU. CHAPTER VI PROCEDURE FOR COMPARISON AND DATA TRANSMISSION FOR LAW ENFORCEMENT PURPOSES Article 19 Procedure for comparison of fingerprint data with Eurodac data 1. For the purposes laid down in Article 1(2), the designated authorities referred to in Articles 5(1) and 7(2) may submit a reasoned electronic request as provided for in Article 20(1) together with the reference number used by them, to the verifying authority for the transmission for comparison of fingerprint data to the Central System via the National Access Point. Upon receipt of such a request, the verifying authority shall verify whether all the conditions for requesting a comparison referred to in Articles 20 or 21, as appropriate, are fulfilled. 2. Where all the conditions for requesting a comparison referred to in Articles 20 or 21 are fulfilled, the verifying authority shall transmit the request for comparison to the National Access Point which will process it to the Central System in accordance with Article 9(3) and (5) for the purpose of comparison with the data transmitted to the Central System pursuant to Articles 9(1) and 14(2). 3. In exceptional cases of urgency where there is a need to prevent an imminent danger associated with a terrorist offence or other serious criminal offence, the verifying authority may transmit the fingerprint data to the National Access Point for comparison immediately upon receipt of a request by a designated authority and only verify ex-post whether all the conditions for requesting a comparison referred to in Article 20 or Article 21 are fulfilled, including whether an exceptional case of urgency actually existed. The ex-post verification shall take place without undue delay after the processing of the request. 4. Where an ex-post verification determines that the access to Eurodac data was not justified, all the authorities that have accessed such data shall erase the information communicated from Eurodac and shall inform the verifying authority of such erasure. Article 20 Conditions for access to Eurodac by designated authorities 1. For the purposes laid down in Article 1(2), designated authorities may submit a reasoned electronic request for the comparison of fingerprint data with the data stored in the Central System within the scope of their powers only if comparisons with the following databases did not lead to the establishment of the identity of the data subject: \u2014 national fingerprint databases; \u2014 the automated fingerprinting identification systems of all other Member States under Decision 2008/615/JHA where comparisons are technically available, unless there are reasonable grounds to believe that a comparison with such systems would not lead to the establishment of the identity of the data subject. Such reasonable grounds shall be included in the reasoned electronic request for comparison with Eurodac data sent by the designated authority to the verifying authority; and \u2014 the Visa Information System provided that the conditions for such a comparison laid down in Decision 2008/633/JHA are met; and where the following cumulative conditions are met: (a) the comparison is necessary for the purpose of the prevention, detection or investigation of terrorist offences or of other serious criminal offences, which means that there is an overriding public security concern which makes the searching of the database proportionate; (b) the comparison is necessary in a specific case (i.e. systematic comparisons shall not be carried out); and (c) there are reasonable grounds to consider that the comparison will substantially contribute to the prevention, detection or investigation of any of the criminal offences in question. Such reasonable grounds exist in particular where there is a substantiated suspicion that the suspect, perpetrator or victim of a terrorist offence or other serious criminal offence falls in a category covered by this Regulation. 2. Requests for comparison with Eurodac data shall be limited to searching with fingerprint data. Article 21 Conditions for access to Eurodac by Europol 1. For the purposes laid down in Article 1(2), Europol's designated authority may submit a reasoned electronic request for the comparison of fingerprint data with the data stored in the Central System within the limits of Europol's mandate and where necessary for the performance of Europol's tasks only if comparisons with fingerprint data stored in any information processing systems that are technically and legally accessible by Europol did not lead to the establishment of the identity of the data subject and where the following cumulative conditions are met: (a) the comparison is necessary to support and strengthen action by Member States in preventing, detecting or investigating terrorist offences or other serious criminal offences falling under Europol's mandate, which means that there is an overriding public security concern which makes the searching of the database proportionate; (b) the comparison is necessary in a specific case (i.e. systematic comparisons shall not be carried out); and (c) there are reasonable grounds to consider that the comparison will substantially contribute to the prevention, detection or investigation of any of the criminal offences in question. Such reasonable grounds exist in particular where there is a substantiated suspicion that the suspect, perpetrator or victim of a terrorist offence or other serious criminal offence falls in a category covered by this Regulation. 2. Requests for comparison with Eurodac data shall be limited to comparisons of fingerprint data. 3. Processing of information obtained by Europol from comparison with Eurodac data shall be subject to the authorisation of the Member State of origin. Such authorisation shall be obtained via the Europol national unit of that Member State. Article 22 Communication between the designated authorities, the verifying authorities and the National Access Points 1. Without prejudice to Article 26, all communication between the designated authorities, the verifying authorities and the National Access Points shall be secure and take place electronically. 2. For the purposes laid down in Article 1(2), fingerprints shall be digitally processed by the Member States and transmitted in the data format referred to in Annex I, in order to ensure that the comparison can be carried out by means of the computerised fingerprint recognition system. CHAPTER VII DATA PROCESSING, DATA PROTECTION AND LIABILITY Article 23 Responsibility for data processing 1. The Member State of origin shall be responsible for ensuring that: (a) fingerprints are taken lawfully; (b) fingerprint data and the other data referred to in Article 11, Article 14(2) and Article 17(2) are lawfully transmitted to the Central System; (c) data are accurate and up-to-date when they are transmitted to the Central System; (d) without prejudice to the responsibilities of the Agency, data in the Central System are lawfully recorded, stored, corrected and erased; (e) the results of fingerprint data comparisons transmitted by the Central System are lawfully processed. 2. In accordance with Article 34, the Member State of origin shall ensure the security of the data referred to in paragraph 1 before and during transmission to the Central System as well as the security of the data it receives from the Central System. 3. The Member State of origin shall be responsible for the final identification of the data pursuant to Article 25(4). 4. The Agency shall ensure that the Central System is operated in accordance with the provisions of this Regulation. In particular, the Agency shall: (a) adopt measures ensuring that persons working with the Central System process the data recorded therein only in accordance with the purposes of Eurodac as laid down in Article 1; (b) take the necessary measures to ensure the security of the Central System in accordance with Article 34; (c) ensure that only persons authorised to work with the Central System have access thereto, without prejudice to the competences of the European Data Protection Supervisor. The Agency shall inform the European Parliament and the Council as well as the European Data Protection Supervisor of the measures it takes pursuant to the first subparagraph. Article 24 Transmission 1. Fingerprints shall be digitally processed and transmitted in the data format referred to in Annex I. As far as necessary for the efficient operation of the Central System, the Agency shall establish the technical requirements for transmission of the data format by Member States to the Central System and vice versa. The Agency shall ensure that the fingerprint data transmitted by the Member States can be compared by the computerised fingerprint recognition system. 2. Member States shall transmit the data referred to in Article 11, Article 14(2) and Article 17(2) electronically. The data referred to in Article 11 and Article 14(2) shall be automatically recorded in the Central System. As far as necessary for the efficient operation of the Central System, the Agency shall establish the technical requirements to ensure that data can be properly electronically transmitted from the Member States to the Central System and vice versa. 3. The reference number referred to in Articles 11(d), 14(2)(d), 17(1) and 19(1) shall make it possible to relate data unambiguously to one particular person and to the Member State which is transmitting the data. In addition, it shall make it possible to tell whether such data relate to a person referred to in Article 9(1), 14(1) or 17(1). 4. The reference number shall begin with the identification letter or letters by which, in accordance with the norm referred to in Annex I, the Member State transmitting the data is identified. The identification letter or letters shall be followed by the identification of the category of person or request. \"1\" refers to data relating to persons referred to in Article 9(1), \"2\" to persons referred to in Article 14(1), \"3\" to persons referred to in Article 17(1), \"4\" to requests referred to in Article 20, \"5\" to requests referred to in Article 21 and \"9\" to requests referred to in Article 29. 5. The Agency shall establish the technical procedures necessary for Member States to ensure receipt of unambiguous data by the Central System. 6 The Central System shall confirm receipt of the transmitted data as soon as possible. To that end, the Agency shall establish the necessary technical requirements to ensure that Member States receive the confirmation receipt if requested. Article 25 Carrying out comparisons and transmitting results 1. Member States shall ensure the transmission of fingerprint data of an appropriate quality for the purpose of comparison by means of the computerised fingerprint recognition system. As far as necessary to ensure that the results of the comparison by the Central System reach a very high level of accuracy, the Agency shall define the appropriate quality of transmitted fingerprint data. The Central System shall, as soon as possible, check the quality of the fingerprint data transmitted. If fingerprint data do not lend themselves to comparison using the computerised fingerprint recognition system, the Central System shall inform the Member State concerned. That Member State shall then transmit fingerprint data of the appropriate quality using the same reference number as the previous set of fingerprint data. 2. The Central System shall carry out comparisons in the order of arrival of requests. Each request shall be dealt with within 24 hours. A Member State may for reasons connected with national law require particularly urgent comparisons to be carried out within one hour. Where such time-limits cannot be respected owing to circumstances which are outside the Agency's responsibility, the Central System shall process the request as a matter of priority as soon as those circumstances no longer prevail. In such cases, as far as is necessary for the efficient operation of the Central System, the Agency shall establish criteria to ensure the priority handling of requests. 3. As far as necessary for the efficient operation of the Central System, the Agency shall establish the operational procedures for the processing of the data received and for transmitting the result of the comparison. 4. The result of the comparison shall be immediately checked in the receiving Member State by a fingerprint expert as defined in accordance with its national rules, specifically trained in the types of fingerprint comparisons provided for in this Regulation. For the purposes laid down in Article 1(1) of this Regulation, final identification shall be made by the Member State of origin in cooperation with the other Member States concerned, pursuant to Article 34 of Regulation (EU) No 604/2013. Information received from the Central System relating to other data found to be unreliable shall be erased as soon as the unreliability of the data is established. 5. Where final identification in accordance with paragraph 4 reveals that the result of the comparison received from the Central System does not correspond to the fingerprint data sent for comparison, Member States shall immediately erase the result of the comparison and communicate this fact as soon as possible and no later than after three working days to the Commission and to the Agency. Article 26 Communication between Member States and the Central System Data transmitted from the Member States to the Central System and vice versa shall use the Communication Infrastructure. As far as is necessary for the efficient operation of the Central System, the Agency shall establish the technical procedures necessary for the use of the Communication Infrastructure. Article 27 Access to, and correction or erasure of, data recorded in Eurodac 1. The Member State of origin shall have access to data which it has transmitted and which are recorded in the Central System in accordance with this Regulation. No Member State may conduct searches of the data transmitted by another Member State, nor may it receive such data apart from data resulting from the comparison referred to in Article 9(5). 2. The authorities of Member States which, pursuant to paragraph 1 of this Article, have access to data recorded in the Central System shall be those designated by each Member State for the purposes laid down in Article 1(1). That designation shall specify the exact unit responsible for carrying out tasks related to the application of this Regulation. Each Member State shall without delay communicate to the Commission and the Agency a list of those units and any amendments thereto. The Agency shall publish the consolidated list in the Official Journal of the European Union. Where there are amendments thereto, the Agency shall publish once a year an updated consolidated list online. 3. Only the Member State of origin shall have the right to amend the data which it has transmitted to the Central System by correcting or supplementing such data, or to erase them, without prejudice to erasure carried out in pursuance of Article 12(2) or 16(1). 4. If a Member State or the Agency has evidence to suggest that data recorded in the Central System are factually inaccurate, it shall advise the Member State of origin as soon as possible. If a Member State has evidence to suggest that data were recorded in the Central System in breach of this Regulation, it shall advise the Agency, the Commission and the Member State of origin as soon as possible. The Member State of origin shall check the data concerned and, if necessary, amend or erase them without delay. 5. The Agency shall not transfer or make available to the authorities of any third country data recorded in the Central System. This prohibition shall not apply to transfers of such data to third countries to which Regulation (EU) No 604/2013 applies. Article 28 Keeping of records 1. The Agency shall keep records of all data processing operations within the Central System. These records shall show the purpose, date and time of access, the data transmitted, the data used for interrogation and the name of both the unit entering or retrieving the data and the persons responsible. 2. The records referred to in paragraph 1 of this Article may be used only for the data protection monitoring of the admissibility of data processing as well as to ensure data security pursuant to Article 34. The records must be protected by appropriate measures against unauthorised access and erased after a period of one year after the storage period referred to in Article 12(1) and in Article 16(1) has expired, unless they are required for monitoring procedures which have already begun. 3. For the purposes laid down in Article 1(1), each Member State shall take the necessary measures in order to achieve the objectives set out in paragraphs 1 and 2 of this Article in relation to its national system. In addition, each Member State shall keep records of the staff duly authorised to enter or retrieve the data. Article 29 Rights of the data subject 1. A person covered by Article 9(1), Article 14(1) or Article 17(1) shall be informed by the Member State of origin in writing, and where necessary, orally, in a language that he or she understands or is reasonably supposed to understand, of the following: (a) the identity of the controller within the meaning of Article 2(d) of Directive 95/46/EC and of his or her representative, if any; (b) the purpose for which his or her data will be processed in Eurodac, including a description of the aims of Regulation (EU) No 604/2013, in accordance with Article 4 thereof and an explanation in intelligible form, using clear and plain language, of the fact that Eurodac may be accessed by the Member States and Europol for law enforcement purposes; (c) the recipients of the data; (d) in relation to a person covered by Article 9(1) or 14(1), the obligation to have his or her fingerprints taken; (e) the right of access to data relating to him or her, and the right to request that inaccurate data relating to him or her be corrected or that unlawfully processed data relating to him or her be erased, as well as the right to receive information on the procedures for exercising those rights including the contact details of the controller and the national supervisory authorities referred to in Article 30(1). 2. In relation to a person covered by Article 9(1) or 14(1), the information referred to in paragraph 1 of this Article shall be provided at the time when his or her fingerprints are taken. In relation to a person covered by Article 17(1), the information referred to in paragraph 1 of this Article shall be provided no later than at the time when the data relating to that person are transmitted to the Central System. That obligation shall not apply where the provision of such information proves impossible or would involve a disproportionate effort. Where a person covered by Article 9(1), Article 14(1) and Article 17(1) is a minor, Member States shall provide the information in an age-appropriate manner. 3. A common leaflet, containing at least the information referred to in paragraph 1 of this Article and the information referred to in Article 4(1) of Regulation (EU) No 604/2013 shall be drawn up in accordance with the procedure referred to in Article 44(2) of that Regulation. The leaflet shall be clear and simple, drafted in a language that the person concerned understands or is reasonably supposed to understand. The leaflet shall be established in such a manner as to enable Member States to complete it with additional Member State-specific information. This Member State-specific information shall include at least the rights of the data subject, the possibility of assistance by the national supervisory authorities, as well as the contact details of the office of the controller and the national supervisory authorities. 4. For the purposes laid down in Article 1(1) of this Regulation, in each Member State any data subject may, in accordance with the laws, regulations and procedures of that State, exercise the rights provided for in Article 12 of Directive 95/46/EC. Without prejudice to the obligation to provide other information in accordance with Article 12(a) of Directive 95/46/EC, the data subject shall have the right to obtain communication of the data relating to him or her recorded in the Central System and of the Member State which transmitted them to the Central System. Such access to data may be granted only by a Member State. 5. For the purposes laid down in Article 1(1), in each Member State, any person may request that data which are factually inaccurate be corrected or that data recorded unlawfully be erased. The correction and erasure shall be carried out without excessive delay by the Member State which transmitted the data, in accordance with its laws, regulations and procedures. 6. For the purposes laid down in Article 1(1), if the rights of correction and erasure are exercised in a Member State other than that, or those, which transmitted the data, the authorities of that Member State shall contact the authorities of the Member State or States which transmitted the data so that the latter may check the accuracy of the data and the lawfulness of their transmission and recording in the Central System. 7. For the purposes laid down in Article 1(1), if it emerges that data recorded in the Central System are factually inaccurate or have been recorded unlawfully, the Member State which transmitted them shall correct or erase the data in accordance with Article 27(3). That Member State shall confirm in writing to the data subject without excessive delay that it has taken action to correct or erase data relating to him or her. 8. For the purposes laid down in Article 1(1), if the Member State which transmitted the data does not agree that data recorded in the Central System are factually inaccurate or have been recorded unlawfully, it shall explain in writing to the data subject without excessive delay why it is not prepared to correct or erase the data. That Member State shall also provide the data subject with information explaining the steps which he or she can take if he or she does not accept the explanation provided. This shall include information on how to bring an action or, if appropriate, a complaint before the competent authorities or courts of that Member State and any financial or other assistance that is available in accordance with the laws, regulations and procedures of that Member State. 9. Any request under paragraphs 4 and 5 shall contain all the necessary particulars to identify the data subject, including fingerprints. Such data shall be used exclusively to permit the exercise of the rights referred to in paragraphs 4 and 5 and shall be erased immediately afterwards. 10. The competent authorities of the Member States shall cooperate actively to enforce promptly the rights laid down in paragraphs 5, 6 and 7. 11. Whenever a person requests data relating to him or her in accordance with paragraph 4, the competent authority shall keep a record in the form of a written document that such a request was made and how it was addressed, and shall make that document available to the national supervisory authorities without delay. 12. For the purposes laid down in Article 1(1) of this Regulation, in each Member State, the national supervisory authority shall, on the basis of his or her request, assist the data subject in accordance with Article 28(4) of Directive 95/46/EC in exercising his or her rights. 13. For the purposes laid down in Article 1(1) of this Regulation, the national supervisory authority of the Member State which transmitted the data and the national supervisory authority of the Member State in which the data subject is present shall assist and, where requested, advise him or her in exercising his or her right to correct or erase data. Both national supervisory authorities shall cooperate to this end. Requests for such assistance may be made to the national supervisory authority of the Member State in which the data subject is present, which shall transmit the requests to the authority of the Member State which transmitted the data. 14. In each Member State any person may, in accordance with the laws, regulations and procedures of that State, bring an action or, if appropriate, a complaint before the competent authorities or courts of the State if he or she is refused the right of access provided for in paragraph 4. 15. Any person may, in accordance with the laws, regulations and procedures of the Member State which transmitted the data, bring an action or, if appropriate, a complaint before the competent authorities or courts of that State concerning the data relating to him or her recorded in the Central System, in order to exercise his or her rights under paragraph 5. The obligation of the national supervisory authorities to assist and, where requested, advise the data subject in accordance with paragraph 13 shall subsist throughout the proceedings. Article 30 Supervision by the national supervisory authorities 1. For the purposes laid down in Article 1(1) of this Regulation, each Member State shall provide that the national supervisory authority or authorities designated pursuant to Article 28(1) of Directive 95/46/EC shall monitor independently, in accordance with its respective national law, the lawfulness of the processing, in accordance with this Regulation, of personal data by the Member State in question, including their transmission to the Central System. 2. Each Member State shall ensure that its national supervisory authority has access to advice from persons with sufficient knowledge of fingerprint data. Article 31 Supervision by the European Data Protection Supervisor 1. The European Data Protection Supervisor shall ensure that all the personal data processing activities concerning Eurodac, in particular by the Agency, are carried out in accordance with Regulation (EC) No 45/2001 and with this Regulation. 2. The European Data Protection Supervisor shall ensure that an audit of the Agency's personal data processing activities is carried out in accordance with international auditing standards at least every three years. A report of such audit shall be sent to the European Parliament, the Council, the Commission, the Agency, and the national supervisory authorities. The Agency shall be given an opportunity to make comments before the report is adopted. Article 32 Cooperation between national supervisory authorities and the European Data Protection Supervisor 1. The national supervisory authorities and the European Data Protection Supervisor shall, each acting within the scope of their respective competences, cooperate actively in the framework of their responsibilities and shall ensure coordinated supervision of Eurodac. 2. Member States shall ensure that every year an audit of the processing of personal data for the purposes laid down in Article 1(2) is carried out by an independent body, in accordance with Article 33(2), including an analysis of a sample of reasoned electronic requests. The audit shall be attached to the annual report of the Member States referred to in Article 40(7). 3. The national supervisory authorities and the European Data Protection Supervisor shall, each acting within the scope of their respective competences, exchange relevant information, assist each other in carrying out audits and inspections, examine difficulties of interpretation or application of this Regulation, study problems with the exercise of independent supervision or in the exercise of the rights of data subjects, draw up harmonised proposals for joint solutions to any problems and promote awareness of data protection rights, as necessary. 4. For the purpose laid down in paragraph 3, the national supervisory authorities and the European Data Protection Supervisor shall meet at least twice a year. The costs and servicing of these meetings shall be for the account of the European Data Protection Supervisor. Rules of procedure shall be adopted at the first meeting. Further working methods shall be developed jointly as necessary. A joint report of activities shall be sent to the European Parliament, the Council, the Commission and the Agency every two years. Article 33 Protection of personal data for law enforcement purposes 1. Each Member State shall provide that the provisions adopted under national law implementing Framework Decision 2008/977/JHA are also applicable to the processing of personal data by its national authorities for the purposes laid down in Article 1(2) of this Regulation. 2. The monitoring of the lawfulness of the processing of personal data under this Regulation by the Member States for the purposes laid down in Article 1(2) of this Regulation, including their transmission to and from Eurodac, shall be carried out by the national supervisory authorities designated pursuant to Framework Decision 2008/977/JHA. 3. The processing of personal data by Europol pursuant to this Regulation shall be in accordance with Decision 2009/371/JHA and shall be supervised by an independent external data protection supervisor. Articles 30, 31 and 32 of that Decision shall be applicable to the processing of personal data by Europol pursuant to this Regulation. The independent external data protection supervisor shall ensure that the rights of the individual are not violated. 4. Personal data obtained pursuant to this Regulation from Eurodac for the purposes laid down in Article 1(2) shall only be processed for the purposes of the prevention, detection or investigation of the specific case for which the data have been requested by a Member State or by Europol. 5. The Central System, the designated and verifying authorities and Europol shall keep records of the searches for the purpose of permitting the national data protection authorities and the European Data Protection Supervisor to monitor the compliance of data processing with Union data protection rules, including for the purpose of maintaining records in order to prepare the annual reports referred to in Article 40(7). Other than for such purposes, personal data, as well as the records of the searches, shall be erased in all national and Europol files after a period of one month, unless the data are required for the purposes of the specific ongoing criminal investigation for which they were requested by a Member State or by Europol. Article 34 Data security 1. The Member State of origin shall ensure the security of the data before and during transmission to the Central System. 2. Each Member State shall, in relation to all data processed by its competent authorities pursuant to this Regulation, adopt the necessary measures, including a security plan, in order to: (a) physically protect the data, including by making contingency plans for the protection of critical infrastructure; (b) deny unauthorised persons access to national installations in which the Member State carries out operations in accordance with the purposes of Eurodac (checks at entrance to the installation); (c) prevent the unauthorised reading, copying, modification or removal of data media (data media control); (d) prevent the unauthorised input of data and the unauthorised inspection, modification or erasure of stored personal data (storage control); (e) prevent the unauthorised processing of data in Eurodac and any unauthorised modification or erasure of data processed in Eurodac (control of data entry); (f) ensure that persons authorised to access Eurodac have access only to the data covered by their access authorisation, by means of individual and unique user IDs and confidential access modes only (data access control); (g) ensure that all authorities with a right of access to Eurodac create profiles describing the functions and responsibilities of persons who are authorised to access, enter, update, erase and search the data, and make those profiles and any other relevant information which those authorities may require for supervisory purposes available to the national supervisory authorities referred to in Article 28 of Directive 95/46/EC and in Article 25 of Framework Decision 2008/977/JHA without delay at their request (personnel profiles); (h) ensure that it is possible to verify and establish to which bodies personal data may be transmitted using data communication equipment (communication control); (i) ensure that it is possible to verify and establish what data have been processed in Eurodac, when, by whom and for what purpose (control of data recording); (j) prevent the unauthorised reading, copying, modification or erasure of personal data during the transmission of personal data to or from Eurodac or during the transport of data media, in particular by means of appropriate encryption techniques (transport control); (k) monitor the effectiveness of the security measures referred to in this paragraph and take the necessary organisational measures related to internal monitoring in order to ensure compliance with this Regulation (self-auditing) and to automatically detect within 24 hours any relevant events arising from the application of measures listed in points (b) to (j) that might indicate the occurrence of a security incident. 3. Member States shall inform the Agency of security incidents detected on their systems. The Agency shall inform the Member States, Europol and the European Data Protection Supervisor in case of security incidents. The Member States concerned, the Agency and Europol shall collaborate during a security incident. 4. The Agency shall take the necessary measures in order to achieve the objectives set out in paragraph 2 as regards the operation of Eurodac, including the adoption of a security plan. Article 35 Prohibition of transfers of data to third countries, international organisations or private entities 1. Personal data obtained by a Member State or Europol pursuant to this Regulation from the Central System shall not be transferred or made available to any third country, international organisation or private entity established in or outside the Union. This prohibition shall also apply if those data are further processed at national level or between Member States within the meaning of Article 2(b) of Framework Decision 2008/977/JHA. 2. Personal data which originated in a Member State and are exchanged between Member States following a hit obtained for the purposes laid down in Article 1(2) shall not be transferred to third countries if there is a serious risk that as a result of such transfer the data subject may be subjected to torture, inhuman and degrading treatment or punishment or any other violation of his or her fundamental rights. 3. The prohibitions referred to in paragraphs 1 and 2 shall be without prejudice to the right of Member States to transfer such data to third countries to which Regulation (EU) No 604/2013 applies. Article 36 Logging and documentation 1. Each Member State and Europol shall ensure that all data processing operations resulting from requests for comparison with Eurodac data for the purposes laid down in Article 1(2) are logged or documented for the purposes of checking the admissibility of the request, monitoring the lawfulness of the data processing and data integrity and security, and self-monitoring. 2. The log or documentation shall show in all cases: (a) the exact purpose of the request for comparison, including the concerned form of a terrorist offence or other serious criminal offence and, for Europol, the exact purpose of the request for comparison; (b) the reasonable grounds given not to conduct comparisons with other Member States under Decision 2008/615/JHA, in accordance with Article 20(1) of this Regulation; (c) the national file reference; (d) the date and exact time of the request for comparison by the National Access Point to the Central System; (e) the name of the authority having requested access for comparison, and the person responsible who made the request and processed the data; (f) where applicable, the use of the urgent procedure referred to in Article 19(3) and the decision taken with regard to the ex-post verification; (g) the data used for comparison; (h) in accordance with national rules or with Decision 2009/371/JHA, the identifying mark of the official who carried out the search and of the official who ordered the search or supply. 3. Logs and documentation shall be used only for monitoring the lawfulness of data processing and for ensuring data integrity and security. Only logs containing non-personal data may be used for the monitoring and evaluation referred to in Article 40. The competent national supervisory authorities responsible for checking the admissibility of the request and monitoring the lawfulness of the data processing and data integrity and security shall have access to these logs at their request for the purpose of fulfilling their duties. Article 37 Liability 1. Any person who, or Member State which, has suffered damage as a result of an unlawful processing operation or any act incompatible with this Regulation shall be entitled to receive compensation from the Member State responsible for the damage suffered. That State shall be exempted from its liability, in whole or in part, if it proves that it is not responsible for the event giving rise to the damage. 2. If the failure of a Member State to comply with its obligations under this Regulation causes damage to the Central System, that Member State shall be liable for such damage, unless and insofar as the Agency or another Member State failed to take reasonable steps to prevent the damage from occurring or to minimise its impact. 3. Claims for compensation against a Member State for the damage referred to in paragraphs 1 and 2 shall be governed by the provisions of national law of the defendant Member State. CHAPTER VIII AMENDMENTS TO REGULATION (EU) NO 1077/2011 Article 38 Amendments to Regulation (EU) No 1077/2011 Regulation (EU) No 1077/2011 is amended as follows: (1) Article 5 is replaced by the following: \"Article 5 Tasks relating to Eurodac In relation to Eurodac, the Agency shall perform: (a) the tasks conferred on it by Regulation (EU) No 603/2013 of the European Parliament and of the Council of 26 June 2013 on the establishment of \u2027Eurodac\u2027 for the comparison of fingerprints for the effective application of Regulation (EU) No 604/2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person), and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes (17); and (b) tasks relating to training on the technical use of Eurodac. (2) Article 12(1) is amended as follows: (a) points (u) and (v) are replaced by the following: \"(u) adopt the annual report on the activities of the Central System of Eurodac pursuant to Article 40(1) of Regulation (EU) No 603/2013; (v) make comments on the European Data Protection Supervisor's reports on the audits pursuant to Article 45(2) of Regulation (EC) No 1987/2006, Article 42(2) of Regulation (EC) No 767/2008 and Article 31(2) of Regulation (EU) No 603/2013 and ensure appropriate follow-up of those audits;\"; (b) point (x) is replaced by the following: \"(x) compile statistics on the work of the Central System of Eurodac pursuant to Article 8(2) of Regulation (EU) No 603/2013;\"; (c) point (z) is replaced by the following: \"(z) ensure annual publication of the list of units pursuant to Article 27(2) of Regulation (EU) No 603/2013;\"; (3) Article 15(4) is replaced by the following: \"4. Europol and Eurojust may attend the meetings of the Management Board as observers when a question concerning SIS II, in relation to the application of Decision 2007/533/JHA, is on the agenda. Europol may also attend the meetings of the Management Board as observer when a question concerning VIS, in relation to the application of Decision 2008/633/JHA, or a question concerning Eurodac, in relation to the application of Regulation (EU) No 603/2013, is on the agenda.\"; (4) Article 17 is amended as follows: (a) in paragraph 5, point (g) is replaced by the following: \"(g) without prejudice to Article 17 of the Staff Regulations, establish confidentiality requirements in order to comply with Article 17 of Regulation (EC) No 1987/2006, Article 17 of Decision 2007/533/JHA, Article 26(9) of Regulation (EC) No 767/2008 and Article 4(4) of Regulation (EU) No 603/2013;\"; (b) in paragraph 6, point (i) is replaced by the following: \"(i) reports on the technical functioning of each large-scale IT system referred to in Article 12(1)(t) and the annual report on the activities of the Central System of Eurodac referred to in Article 12(1)(u), on the basis of the results of monitoring and evaluation.\"; (5) Article 19(3) is replaced by the following: \"3. Europol and Eurojust may each appoint a representative to the SIS II Advisory Group. Europol may also appoint a representative to the VIS and Eurodac Advisory Groups.\". CHAPTER IX FINAL PROVISIONS Article 39 Costs 1. The costs incurred in connection with the establishment and operation of the Central System and the Communication Infrastructure shall be borne by the general budget of the European Union. 2. The costs incurred by national access points and the costs for connection to the Central System shall be borne by each Member State. 3. Each Member State and Europol shall set up and maintain at their expense the technical infrastructure necessary to implement this Regulation, and shall be responsible for bearing its costs resulting from requests for comparison with Eurodac data for the purposes laid down in Article 1(2) Article 40 Annual report: monitoring and evaluation 1. The Agency shall submit to the European Parliament, the Council, the Commission and the European Data Protection Supervisor an annual report on the activities of the Central System, including on its technical functioning and security. The annual report shall include information on the management and performance of Eurodac against pre-defined quantitative indicators for the objectives referred to in paragraph 2. 2. The Agency shall ensure that procedures are in place to monitor the functioning of the Central System against objectives relating to output, cost-effectiveness and quality of service. 3. For the purposes of technical maintenance, reporting and statistics, the Agency shall have access to the necessary information relating to the processing operations performed in the Central System. 4. By 20 July 2018 and every four years thereafter, the Commission shall produce an overall evaluation of Eurodac, examining the results achieved against objectives and the impact on fundamental rights, including whether law enforcement access has led to indirect discrimination against persons covered by this Regulation, and assessing the continuing validity of the underlying rationale and any implications for future operations, and shall make any necessary recommendations. The Commission shall transmit the evaluation to the European Parliament and the Council. 5. Member States shall provide the Agency and the Commission with the information necessary to draft the annual report referred to in paragraph 1. 6. The Agency, Member States and Europol shall provide the Commission with the information necessary to draft the overall evaluation provided for in paragraph 4. This information shall not jeopardise working methods or include information that reveals sources, staff members or investigations of the designated authorities. 7. While respecting the provisions of national law on the publication of sensitive information, each Member State and Europol shall prepare annual reports on the effectiveness of the comparison of fingerprint data with Eurodac data for law enforcement purposes, containing information and statistics on: \u2014 the exact purpose of the comparison, including the type of terrorist offence or serious criminal offence, \u2014 grounds given for reasonable suspicion, \u2014 the reasonable grounds given not to conduct comparison with other Member States under Decision 2008/615/JHA, in accordance with Article 20(1) of this Regulation, \u2014 number of requests for comparison, \u2014 the number and type of cases which have ended in successful identifications, and \u2014 the need and use made of the exceptional case of urgency, including those cases where that urgency was not accepted by the ex post verification carried out by the verifying authority. Member States' and Europol annual reports shall be transmitted to the Commission by 30 June of the subsequent year. 8. On the basis of Member States and Europol annual reports provided for in paragraph 7 and in addition to the overall evaluation provided for in paragraph 4, the Commission shall compile an annual report on law enforcement access to Eurodac and shall transmit it to the European Parliament, the Council and the European Data Protection Supervisor. Article 41 Penalties Member States shall take the necessary measures to ensure that any processing of data entered in the Central System contrary to the purposes of Eurodac as laid down in Article 1 is punishable by penalties, including administrative and/or criminal penalties in accordance with national law, that are effective, proportionate and dissuasive. Article 42 Territorial scope The provisions of this Regulation shall not be applicable to any territory to which Regulation (EU) No 604/2013 does not apply. Article 43 Notification of designated authorities and verifying authorities 1. By 20 October 2013, each Member State shall notify the Commission of its designated authorities, of the operating units referred to in Article 5(3) and of its verifying authority, and shall notify without delay any amendment thereto. 2. By 20 October 2013, Europol shall notify the Commission of its designated authority, of its verifying authority and of the National Access Point which it has designated, and shall notify without delay any amendment thereto. 3. The Commission shall publish the information referred to in paragraphs 1 and 2 in the Official Journal of the European Union on an annual basis and via an electronic publication that shall be available online and updated without delay. Article 44 Transitional provision Data blocked in the Central System in accordance with Article 12 of Regulation (EC) No 2725/2000 shall be unblocked and marked in accordance with Article 18(1) of this Regulation on 20 July 2015. Article 45 Repeal Regulation (EC) No 2725/2000 and Regulation (EC) No 407/2002 are repealed with effect from 20 July 2015. References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III. Article 46 Entry into force and applicability This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall apply from 20 July 2015. Member States shall notify the Commission and the Agency as soon as they have made the technical arrangements to transmit data to the Central System, and in any event no later than 20 July 2015. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 26 June 2013. For the European Parliament The President M. SCHULZ For the Council The President A. SHATTER (1) OJ C 92 10.4.2010, p. 1. (2) Position of the European Parliament of 12 June 2013 (not yet published in the Official Journal) and decision of the Council of 20 June 2013. (3) OJ L 316, 15.12.2000, p. 1. (4) OJ L 62, 5.3.2002, p. 1. (5) See page 31 of this Official Journal. (6) OJ L 164, 22.6.2002, p. 3. (7) OJ L 190, 18.7.2002, p. 1. (8) OJ L 121, 15.5.2009, p. 37. (9) OJ L 337, 20.12.2011, p. 9. (10) OJ L 286, 1.11.2011, p. 1. (11) OJ L 56, 4.3.1968, p. 1. (12) OJ L 210, 6.8.2008, p. 1. (13) OJ L 218, 13.8.2008, p. 129. (14) OJ L 281, 23.11.1995, p. 31. (15) OJ L 350, 30.12.2008, p. 60. (16) OJ L 8, 12.1.2001, p. 1. (17) OJ L 180, 29.6.2013, p. 1.\"; ANNEX I Data format and fingerprint form Data format for the exchange of fingerprint data The following format is prescribed for the exchange of fingerprint data: ANSI/NIST-ITL 1a-1997, Ver.3, June 2001 (INT-1) and any future further developments of this standard. Norm for Member State identification letters The following ISO norm will apply: ISO 3166 - 2 letters code. ANNEX II Repealed Regulations (referred to in Article 45) Council Regulation (EC) No 2725/2000 (OJ L 316, 15.12.2000, p. 1.) Council Regulation (EC) No 407/2002 (OJ L 62, 5.3.2002 p. 1.) ANNEX III Correlation table Regulation (EC) No 2725/2000 This Regulation Article 1(1) Article 1(1) Article 1(2), first subparagraph, points (a) and (b) Article 3(1)(a) Article 1(2), first subparagraph, point (c) \u2014 Article 1(2), second subparagraph Article 3(4) Article 1(3) Article 1(3) Article 2(1)(a) \u2014 Article 2(1)(b) to (e) Article 2(1)(a) to (d) \u2014 Article 2(1)(e) to (j) Article 3(1) \u2014 Article 3(2) Article 3(3) Article 3(3)(a) to (e) Article 8(1)(a) to (e) \u2014 Article 8(1)(f) to (i) Article 3(4) \u2014 Article 4(1) Article 9(1) and Article 3(5) Article 4(2) \u2014 Article 4(3) Article 9(3) Article 4(4) Article 9(4) Article 4(5) Article 9(5) Article 4(6) Article 25(4) Article 5(1), points (a) to (f) Article 11, points (a) to (f) \u2014 Article 11, points (g) to (k) Article 5(1), points (g) and (h) \u2014 Article 6 Article 12 Article 7 Article 13 Article 8 Article 14 Article 9 Article 15 Article 10 Article 16 Article 11(1) to (3) Article 17(1) to (3) Article 11(4) Article 17(5) Article 11(5) Article 17(4) Article 12 Article 18 Article 13 Article 23 Article 14 \u2014 Article 15 Article 27 Article 16 Article 28(1) and (2) \u2014 Article 28(3) Article 17 Article 37 Article 18 Article 29(1), (2), (4) to (10) and (12) to (15) \u2014 Article 29(3) and (11) Article 19 Article 30 \u2014 Articles 31 to 36 Article 20 \u2014 Article 21 Article 39(1) and (2) Article 22 \u2014 Article 23 \u2014 Article 24(1) and (2) Article 40(1) and (2) \u2014 Article 40(3) to (8) Article 25 Article 41 Article 26 Article 42 \u2014 Articles 43 to 45 Article 27 Article 46 Regulation 407/2002/EC This Regulation Article 2 Article 24 Article 3 Article 25(1) to (3) \u2014 Article 25(4) and (5) Article 4 Article 26 Article 5(1) Article 3(3) Annex I Annex I Annex II \u2014", "summary": "Eurodac: European system for the comparison of fingerprints of asylum applicants Eurodac: European system for the comparison of fingerprints of asylum applicants SUMMARY OF: Regulation (EU) No 603/2013 on \u2018Eurodac\u2019 \u2014 EU asylum fingerprint database for comparing asylum applicants\u2019 fingerprints WHAT IS THE AIM OF THE REGULATION? It expands Eurodac, which is an EU-wide biometric database containing fingerprints of asylum applicants and non-EU/European Economic Area (EEA) nationals for comparison between EU countries. The aim is to: make it easier for EU countries to determine responsibility for examining an asylum application by comparing the fingerprints of asylum applicants and non-EU/EEA nationals against a central database; andenable law-enforcement authorities, subject to strict conditions, to consult Eurodac for the investigation, detection and prevention of terrorist or serious criminal offences. KEY POINTS Each EU country must take the fingerprints of all asylum applicants and those apprehended while trying to cross a border irregularly (e.g. non-EU/EEA nationals or stateless persons entering without valid documents) over the age of 14 and, within 72 hours, transmit the data to Eurodac. When an asylum applicant or non-EU/EEA national has been found to be present illegally in an EU country, then that EU country can consult Eurodac to determine whether the individual has previously applied for asylum in an EU country or has previously been apprehended when trying to unlawfully enter the EU. Fingerprint data should be erased once asylum applicants, non-EU/EEA nationals or stateless persons obtain citizenship of an EU country. This regulation helps apply the Dublin III Regulation (Regulation (EU) No 604/2013), which lays down rules for determining which EU country is responsible for examining an asylum application. The original Eurodac legislation (Council Regulation (EC) No 2725/2000) did not offer a means for law enforcement authorities to request data comparisons. This regulation, however, allows police forces and Europol to compare fingerprints linked to criminal investigations with those contained in Eurodac. However, due to the fundamental right to privacy, law-enforcement agencies are only allowed to use Eurodac for comparisons: where there are reasonable grounds that doing so will substantially assist them in preventing, detecting or investigating a terrorist offence or other serious criminal offence; andonly as a last resort after several other checks have been carried out first. No Eurodac data may be shared with non-EU countries (other than Iceland and Norway). Some asylum applicants and non-EU/EEA nationals or stateless persons have refused to cooperate with EU countries\u2019 attempts to fingerprint them for the Eurodac database. This led the European Commission to issue a document on possible best practice relating to fingerprinting. The Protocol between the EU, Iceland and Norway, signed in 2020, extends the application of Regulation (EU) No 603/2013 to Norway and Iceland. FROM WHEN DOES THE REGULATION APPLY? It has applied since 20 July 2015. BACKGROUND Eurodac was originally created in 2000 (Council Regulation (EC) No 2725/2000) and it has been operating since 2003. The Commission considers it to be a very successful information technology (IT) tool. Identification of applicants (Eurodac) (European Commission). MAIN DOCUMENT Regulation (EU) No 603/2013 of the European Parliament and of the Council of 26 June 2013 on the establishment of \u2018Eurodac\u2019 for the comparison of fingerprints for the effective application of Regulation (EU) No 604/2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person and on requests for the comparison with Eurodac data by Member States\u2019 law enforcement authorities and Europol for law enforcement purposes, and amending Regulation (EU) No 1077/2011 establishing a European Agency for the Operational Management of large-scale IT Systems in the area of freedom, security and justice (OJ L 180, 29.6.2013, pp. 1-30) RELATED DOCUMENTS Protocol between the European Union, Iceland and the Kingdom of Norway to the Agreement between the European Community and the Republic of Iceland and the Kingdom of Norway concerning the criteria and mechanisms for establishing the State responsible for examining a request for asylum lodged in a Member State or in Iceland or Norway regarding access to Eurodac for law enforcement purposes (OJ L 64, 3.3.2020, pp. 3-7) Commission staff working document on implementation of the Eurodac regulation as regards the obligation to take fingerprints (SWD(2015) 150 final of 27.5.2015) Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person (OJ L 180, 29.6.2013, pp. 31-59) Successive amendments to Regulation (EU) No 604/2013 have been incorporated into the original text. This consolidated version is of documentary value only. last update 03.06.2020"}
{"article": "14.12.2012 EN Official Journal of the European Union L 343/1 REGULATION (EU) No 1151/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 November 2012 on quality schemes for agricultural products and foodstuffs THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) and the first paragraph of Article 118 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The quality and diversity of the Union\u2019s agricultural, fisheries and aquaculture production is one of its important strengths, giving a competitive advantage to the Union\u2019s producers and making a major contribution to its living cultural and gastronomic heritage. This is due to the skills and determination of Union farmers and producers who have kept traditions alive while taking into account the developments of new production methods and material. (2) Citizens and consumers in the Union increasingly demand quality as well as traditional products. They are also concerned to maintain the diversity of the agricultural production in the Union. This generates a demand for agricultural products or foodstuffs with identifiable specific characteristics, in particular those linked to their geographical origin. (3) Producers can only continue to produce a diverse range of quality products if they are rewarded fairly for their effort. This requires that they are able to communicate to buyers and consumers the characteristics of their product under conditions of fair competition. It also requires them to be able to correctly identify their products on the marketplace. (4) Operating quality schemes for producers which reward them for their efforts to produce a diverse range of quality products can benefit the rural economy. This is particularly the case in less favoured areas, in mountain areas and in the most remote regions, where the farming sector accounts for a significant part of the economy and production costs are high. In this way quality schemes are able to contribute to and complement rural development policy as well as market and income support policies of the common agricultural policy (CAP). In particular, they may contribute to areas in which the farming sector is of greater economic importance and, especially, to disadvantaged areas. (5) The Europe 2020 policy priorities as set out in the Commission Communication entitled \u2018Europe 2020: A strategy for smart, sustainable and inclusive growth\u2019, include the aims of achieving a competitive economy based on knowledge and innovation and fostering a high-employment economy delivering social and territorial cohesion. Agricultural product quality policy should therefore provide producers with the right tools to better identify and promote those of their products that have specific characteristics while protecting those producers against unfair practices. (6) The set of complementary measures envisaged should respect the principles of subsidiarity and proportionality. (7) Agricultural product quality policy measures are laid down in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine-based drinks and aromatized wine-product cocktails (4); Council Directive 2001/110/EC of 20 December 2001 relating to honey (5) and in particular in Article 2 thereof, Council Regulation (EC) No 247/2006 of 30 January 2006 laying down specific measures for agriculture in the outermost regions of the Union (6) and in particular in Article 14 thereof; Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed (7); Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (8); Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (9) and in particular in Part II, Title II, Chapter I, Section I and in Section Ia, Subsection I thereof; Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products (10); and Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks (11). (8) The labelling of agricultural products and foodstuffs should be subject to the general rules laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (12), and in particular the provisions aimed at preventing labelling that may confuse or mislead consumers. (9) The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on agricultural product quality policy identified the achievement of a greater overall coherence and consistency of agricultural product quality policy as a priority. (10) The geographical indications scheme for agricultural products and foodstuffs and the traditional specialities guaranteed scheme have certain common objectives and provisions. (11) The Union has for some time been pursuing an approach that aims to simplify the regulatory framework of the CAP. This approach should also be applied to regulations in the field of agricultural product quality policy, without, in so doing, calling into question the specific characteristics of those products. (12) Some regulations that form part of the agricultural product quality policy have been reviewed recently but are not yet fully implemented. As a result, they should not be included in this Regulation. However, they may be incorporated at a later stage, once the legislation has been fully implemented. (13) In the light of the aforementioned considerations, the following provisions should be amalgamated into a single legal framework comprising the new or updated provisions of Regulations (EC) No 509/2006 and (EC) No 510/2006 and those provisions of Regulations (EC) No 509/2006 and (EC) No 510/2006 that are maintained. (14) In the interests of clarity and transparency, Regulations (EC) No 509/2006 and (EC) No 510/2006 should therefore be repealed and replaced by this Regulation. (15) The scope of this Regulation should be limited to the agricultural products intended for human consumption listed in Annex I to the Treaty and to a list of products outside the scope of that Annex that are closely linked to agricultural production or to the rural economy. (16) The rules provided for in this Regulation should apply without affecting existing Union legislation on wines, aromatised wines, spirit drinks, product of organic farming, or outermost regions. (17) The scope for designations of origin and geographical indications should be limited to products for which an intrinsic link exists between product or foodstuff characteristics and geographical origin. The inclusion in the current scheme of only certain types of chocolate as confectionery products is an anomaly that should be corrected. (18) The specific objectives of protecting designations of origin and geographical indications are securing a fair return for farmers and producers for the qualities and characteristics of a given product, or of its mode of production, and providing clear information on products with specific characteristics linked to geographical origin, thereby enabling consumers to make more informed purchasing choices. (19) Ensuring uniform respect throughout the Union for the intellectual property rights related to names protected in the Union is a priority that can be achieved more effectively at Union level. (20) A Union framework that protects designations of origin and geographical indications by providing for their inclusion on a register facilitates the development of those instruments, since the resulting, more uniform, approach ensures fair competition between the producers of products bearing such indications and enhances the credibility of the products in the consumers\u2019 eyes. Provision should be made for the development of designations of origin and geographical indications at Union level and for promoting the creation of mechanisms for their protection in third countries in the framework of the World Trade Organisation (WTO) or multilateral and bilateral agreements, thereby contributing to the recognition of the quality of products and of their model of production as a factor that adds value. (21) In the light of the experience gained from the implementation of Council Regulation (EEC) No 2081/92 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (13) and Regulation (EC) No 510/2006, there is a need to address certain issues, to clarify and simplify some rules and to streamline the procedures of this scheme. (22) In the light of existing practice, the two different instruments for identifying the link between the product and its geographical origin, namely the protected designation of origin and the protected geographical indication, should be further defined and maintained. Without changing the concept of those instruments, some modifications to the definitions should be adopted in order to better take into account the definition of geographical indications laid down in the Agreement on Trade-Related Aspects of Intellectual Property Rights and to make them simpler and clearer for operators to understand. (23) An agricultural product or foodstuff bearing such a geographical description should meet certain conditions set out in a specification, such as specific requirements aimed at protecting the natural resources or landscape of the production area or improving the welfare of farm animals. (24) To qualify for protection in the territories of Member States, designations of origin and geographical indications should be registered only at Union level. With effect from the date of application for such registration at Union level, Member States should be able to grant transitional protection at national level without affecting intra-Union or international trade. The protection afforded by this Regulation upon registration, should be equally available to designations of origin and geographical indications of third countries that meet the corresponding criteria and that are protected in their country of origin. (25) The registration procedure at Union level should enable any natural or legal person with a legitimate interest from a Member State, other than the Member State of the application, or from a third country, to exercise their rights by notifying their opposition. (26) Entry in the register of protected designations of origin and protected geographical indications should also provide information to consumers and to those involved in trade. (27) The Union negotiates international agreements, including those concerning the protection of designations of origin and geographical indications, with its trade partners. In order to facilitate the provision to the public of information about the names so protected, and in particular to ensure protection and control of the use to which those names are put, the names may be entered in the register of protected designations of origin and protected geographical indications. Unless specifically identified as designations of origin in such international agreements, the names should be entered in the register as protected geographical indications. (28) In view of their specific nature, special provisions concerning labelling should be adopted in respect of protected designations of origin and protected geographical indications that require producers to use the appropriate Union symbols or indications on packaging. In the case of Union names, the use of such symbols or indications should be made obligatory in order to make this category of products, and the guarantees attached to them, better known to consumers and in order to permit easier identification of these products on the market, thereby facilitating checks. Taking into account the requirements of the WTO, the use of such symbols or indications should be made voluntary for third-country geographical indications and designations of origin. (29) Protection should be granted to names included in the register with the aim of ensuring that they are used fairly and in order to prevent practices liable to mislead consumers. In addition, the means of ensuring that geographical indications and designations of origin are protected should be clarified, particularly as regards the role of producer groups and competent authorities of Member States. (30) Provision should be made for specific derogations that permit, for transitional periods, the use of a registered name alongside other names. Those derogations should be simplified and clarified. In certain cases, in order to overcome temporary difficulties and with the long-term objective of ensuring that all producers comply with the specifications, those derogations may be granted for a period of up to 10 years. (31) The scope of the protection granted under this Regulation should be clarified, in particular with regard to those limitations on registration of new trade marks set out in Directive 2008/95/EC of the European Parliament and of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks (14) that conflict with the registration of protected designations of origin and protected geographical indications as is already the case for the registration of new trade marks at Union level. Such clarification is also necessary with regard to the holders of prior rights in intellectual property, in particular those concerning trade marks and homonymous names registered as protected designations of origin or as protected geographical indications. (32) Protection of designations of origin and geographical indications should be extended to the misuse, imitation and evocation of the registered names on goods as well as on services in order to ensure a high level of protection and to align that protection with that which applies to the wine sector. When protected designations of origin or protected geographical indications are used as ingredients, the Commission Communication entitled \u2018Guidelines on the labelling of foodstuffs using protected designations of origin (PDOs) or protected geographical indications (PGIs) as ingredients\u2019 should be taken into account. (33) The names already registered under Regulation (EC) No 510/2006 on 3 January 2013 should continue to be protected under this Regulation and they should be automatically included in the register. (34) The specific objective of the scheme for traditional specialities guaranteed is to help the producers of traditional products to communicate to consumers the value-adding attributes of their product. However, as only a few names have been registered, the current scheme for traditional specialities guaranteed has failed to realise its potential. Current provisions should therefore be improved, clarified and sharpened in order to make the scheme more understandable, operational and attractive to potential applicants. (35) The current scheme provides the option to register a name for identification purposes without reservation of the name in the Union. As this option has not been well understood by stakeholders and since the function of identifying traditional products can be better achieved at Member State or regional level in application of the principle of subsidiarity, this option should be discontinued. In the light of experience, the scheme should only deal with the reservation of names across the Union. (36) To ensure that names of genuine traditional products are registered under the scheme, the criteria and conditions for registration of a name should be adapted, in particular those concerning the definition of \u2018traditional\u2019, which should cover products that have been produced for a significant period of time. (37) To ensure that traditional specialities guaranteed comply with their specification and are consistent, producers organised into groups should themselves define the product in a specification. The option of registering a name as a traditional speciality guaranteed should be open to third-country producers. (38) To qualify for reservation, traditional specialities guaranteed should be registered at Union level. The entry in the register should also provide information to consumers and to those involved in the trade. (39) In order to avoid creating unfair conditions of competition, any producer, including a third-country producer, should be able to use a registered name of a traditional speciality guaranteed, provided that the product concerned complies with the requirements of the relevant specification and the producer is covered by a system of controls. For traditional specialities guaranteed produced within the Union, the Union symbol should be indicated on the labelling and it should be possible to associate it with the indication \u2018traditional speciality guaranteed\u2019. (40) In order to protect registered names from misuse, or from practices that might mislead consumers, their use should be reserved. (41) For those names already registered under Regulation (EC) No 509/2006 that, on 3 January 2013, would otherwise not be covered by the scope of this Regulation, the terms of use laid down in Regulation (EC) No 509/2006 should continue to apply for a transitional period. (42) A procedure should be introduced for registering names that are registered without reservation of name pursuant to Regulation (EC) No 509/2006, enabling them to be registered with reservation of name. (43) Provision should also be made for transitional measures applicable to registration applications received by the Commission before 3 January 2013. (44) A second tier of quality systems, based on quality terms which add value, which can be communicated on the internal market and which are to be applied voluntarily, should be introduced. Those optional quality terms should refer to specific horizontal characteristics, with regard to one or more categories of products, farming methods or processing attributes which apply in specific areas. The optional quality term \u2018mountain product\u2019 has met the conditions up to now and will add value to the product on the market. In order to facilitate the application of Directive 2000/13/EC where the labelling of foodstuffs may give rise to consumer confusion in relation to optional quality terms, including in particular \u2018mountain products\u2019, the Commission may adopt guidelines. (45) In order to provide mountain producers with an effective tool to better market their product and to reduce the actual risks of consumer confusion as to the mountain provenance of products in the market place, provision should be made for the definition at Union level of an optional quality term for mountain products. The definition of mountain areas should build on the general classification criteria employed to identify a mountain area in Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF) (15). (46) The added value of the geographical indications and traditional specialities guaranteed is based on consumer trust. It is only credible if accompanied by effective verification and controls. Those quality schemes should be subject to a monitoring system of official controls, in line with the principles set out in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (16), and should include a system of checks at all stages of production, processing and distribution. In order to help Member States to better apply provisions of Regulation (EC) No 882/2004 for the controls of geographical indications and traditional specialities guaranteed, references to the most relevant articles should be mentioned in this Regulation. (47) To guarantee to the consumer the specific characteristics of geographical indications and traditional specialities guaranteed, operators should be subject to a system that verifies compliance with the product specification. (48) In order to ensure that they are impartial and effective, the competent authorities should meet a number of operational criteria. Provisions on delegating some competences of performing specific control tasks to control bodies should be envisaged. (49) European standards (EN standards) developed by the European Committee for Standardisation (CEN) and international standards developed by the International Organisation for Standardisation (ISO) should be used for the accreditation of the control bodies as well as by those bodies for their operations. The accreditation of those bodies should take place in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (17). (50) Information on control activities for geographical indications and traditional specialities guaranteed should be included in the multiannual national control plans and annual report prepared by the Member States in accordance with Regulation (EC) No 882/2004. (51) Member States should be authorised to charge a fee to cover the costs incurred. (52) Existing rules concerning the continued use of names that are generic should be clarified so that generic terms that are similar to or form part of a name or term that is protected or reserved should retain their generic status. (53) The date for establishing the seniority of a trade mark and of a designation of origin or a geographical indication should be that of the date of application of the trade mark for registration in the Union or in the Member States and the date of application for protection of a designation of origin or a geographical indication to the Commission. (54) The provisions dealing with the refusal or coexistence of a designation of origin or a geographical indication on the ground of conflict with a prior trade mark should continue to apply. (55) The criteria by which subsequent trade marks should be refused or, if registered, invalidated on the ground that they conflict with a prior designation of origin or geographical indication should correspond to the scope of protection of designation of origin or a geographical indication laid down. (56) The provisions of systems establishing intellectual property rights, and particularly of those established by the quality scheme for designations of origin and geographical indications or those established under trade mark law, should not be affected by the reservation of names and the establishment of indications and symbols pursuant to the quality schemes for traditional specialities guaranteed and for optional quality terms. (57) The role of groups should be clarified and recognised. Groups play an essential role in the application process for the registration of names of designations of origin and geographical indications and traditional specialities guaranteed, as well as in the amendment of specifications and cancellation requests. The group can also develop activities related to the surveillance of the enforcement of the protection of the registered names, the compliance of the production with the product specification, the information and promotion of the registered name as well as, in general, any activity aimed at improving the value of the registered names and effectiveness of the quality schemes. Moreover, it should monitor the position of the products on the market. Nevertheless, these activities should not facilitate nor lead to anti-competitive conduct incompatible with Articles 101 and 102 of the Treaty. (58) To ensure that registered names of designations of origin and geographical indications and traditional specialities guaranteed meet the conditions laid down by this Regulation, applications should be examined by the national authorities of the Member State concerned, in compliance with minimum common provisions, including a national opposition procedure. The Commission should subsequently scrutinise applications to ensure that there are no manifest errors and that Union law and the interests of stakeholders outside the Member State of application have been taken into account. (59) Registration as designations of origin, geographical indications and traditional specialities guaranteed should be open to names that relate to products originating in third countries and that satisfy the conditions laid down by this Regulation. (60) The symbols, indications and abbreviations identifying participation in a quality scheme, and the rights therein pertaining to the Union, should be protected in the Union as well as in third countries with the aim of ensuring that they are used on genuine products and that consumers are not misled as to the qualities of products. Furthermore, in order for the protection to be effective, the Commission should have recourse to reasonable budget resources on a centralised basis within the framework of Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (18) and in accordance with Article 5 of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (19). (61) The registration procedure for protected designations of origin, protected geographical indications and traditional specialities guaranteed, including the scrutiny and the opposition periods, should be shortened and improved, in particular as regards decision making. The Commission, in certain circumstances acting with the assistance of Member States, should be responsible for decision-making on registration. Procedures should be laid down to allow the amendment of product specifications after registration and the cancellation of registered names, in particular if the product no longer complies with the corresponding product specification or if a name is no longer used in the market place. (62) In order to facilitate cross-border applications for joint registration of protected designations of origin, protected geographical indications or traditional specialities guaranteed, provision should be made for appropriate procedures. (63) In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of supplementing the list of products set out in Annex I to this Regulation; establishing the restrictions and derogations with regard to the sourcing of feed in the case of a designation of origin; establishing restrictions and derogations with regard to the slaughtering of live animals or with regard to the sourcing of raw materials; laying down rules which limit the information contained in the product specification; establishing the Union symbols; laying down additional transitional rules in order to protect the rights and legitimate interests of producers or stakeholders concerned; laying down further details on the eligibility criteria for the names of traditional specialities guaranteed; laying down detailed rules relating to the criteria for optional quality terms; reserving an additional optional quality term, laying down its conditions of use and amending those conditions; laying down derogations to the use of the term \u2018mountain product\u2019 and establishing the methods of production, and other criteria relevant for the application of that optional quality term, in particular, laying down the conditions under which raw materials or feedstuffs are permitted to come from outside the mountain areas; laying down additional rules for determining the generic status of terms in the Union; laying down rules for determining the use of the name of a plant variety or of an animal breed; defining the rules for carrying out the national objection procedure for joint applications concerning more than one national territory; and for complementing the rules of the application process, the opposition process, the amendment application process and the cancellation process in general. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (64) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards laying down rules on the form of the product specification; laying down detailed rules on the form and content of the register of protected designations of origin and protected geographical indications; defining the technical characteristics of the Union symbols and indications as well as the rules on their use on products, including the appropriate linguistic versions to be used; granting and extending transitional periods for temporary derogations for use of protected designations of origin and protected geographical indication; laying down detailed rules on the form and content of the register of traditional specialities guaranteed; laying down rules for the protection of traditional specialities guaranteed; laying down all measures relating to forms, procedures and other technical details for the application of Title IV; laying down rules for the use of optional quality terms; laying down rules for the uniform protection of indications, abbreviations and symbols referring to the quality schemes; laying down detailed rules on the procedure, form and presentation of applications for registration and of oppositions; rejecting the application; deciding on the registration of a name if an agreement has not been reached; laying down detailed rules on the procedure, form and presentation of an amendment application; cancelling the registration of a protected designation of origin, a protected geographical indication or a traditional speciality guaranteed; and laying down detailed rules on the procedure and form of the cancellation process and on the presentation of the requests for cancellation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (20). (65) In respect of establishing and maintaining registers of protected designations of origin, protected geographical indications and traditional specialties guaranteed, recognised under this scheme; defining the means by which the name and address of product certification bodies are to be made public; and registering a name if there is no notice of opposition or no admissible reasoned statement of opposition or in the case there is one the agreement has been reached, the Commission should be empowered to adopt implementing acts without applying Regulation (EU) No 182/2011, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Objectives 1. This Regulation aims to help producers of agricultural products and foodstuffs to communicate the product characteristics and farming attributes of those products and foodstuffs to buyers and consumers, thereby ensuring: (a) fair competition for farmers and producers of agricultural products and foodstuffs having value-adding characteristics and attributes; (b) the availability to consumers of reliable information pertaining to such products; (c) respect for intellectual property rights; and (d) the integrity of the internal market. The measures set out in this Regulation are intended to support agricultural and processing activities and the farming systems associated with high quality products, thereby contributing to the achievement of rural development policy objectives. 2. This Regulation establishes quality schemes which provide the basis for the identification and, where appropriate, protection of names and terms that, in particular, indicate or describe agricultural products with: (a) value-adding characteristics; or (b) value-adding attributes as a result of the farming or processing methods used in their production, or of the place of their production or marketing. Article 2 Scope 1. This Regulation covers agricultural products intended for human consumption listed in Annex I to the Treaty and other agricultural products and foodstuffs listed in Annex I to this Regulation. In order to take into account international commitments or new production methods or material, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, supplementing the list of products set out in Annex I to this Regulation. Such products shall be closely linked to agricultural products or to the rural economy. 2. This Regulation shall not apply to spirit drinks, aromatised wines or grapevine products as defined in Annex XIb to Regulation (EC) No 1234/2007, with the exception of wine-vinegars. 3. This Regulation shall apply without prejudice to other specific Union provisions relating to the placing of products on the market and, in particular, to the single common organisation of the markets, and to food labelling. 4. Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (21) shall not apply to the quality schemes established by this Regulation. Article 3 Definitions For the purposes of this Regulation the following definitions shall apply: (1) \u2018quality schemes\u2019 means the schemes established under Titles II, III and IV; (2) \u2018group\u2019 means any association, irrespective of its legal form, mainly composed of producers or processors working with the same product; (3) \u2018traditional\u2019 means proven usage on the domestic market for a period that allows transmission between generations; this period is to be at least 30 years; (4) \u2018labelling\u2019 means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff; (5) \u2018specific character\u2019 in relation to a product means the characteristic production attributes which distinguish a product clearly from other similar products of the same category; (6) \u2018generic terms \u2019 means the names of products which, although relating to the place, region or country where the product was originally produced or marketed, have become the common name of a product in the Union; (7) \u2018production step\u2019 means production, processing or preparation; (8) \u2018processed products\u2019 means foodstuffs resulting from the processing of unprocessed products. Processed products may contain ingredients that are necessary for their manufacture or to give them specific characteristics. TITLE II PROTECTED DESIGNATIONS OF ORIGIN AND PROTECTED GEOGRAPHICAL INDICATIONS Article 4 Objective A scheme for protected designations of origin and protected geographical indications is established in order to help producers of products linked to a geographical area by: (a) securing fair returns for the qualities of their products; (b) ensuring uniform protection of the names as an intellectual property right in the territory of the Union; (c) providing clear information on the value-adding attributes of the product to consumers. Article 5 Requirements for designations of origin and geographical indications 1. For the purpose of this Regulation, \u2018designation of origin\u2019 is a name which identifies a product: (a) originating in a specific place, region or, in exceptional cases, a country; (b) whose quality or characteristics are essentially or exclusively due to a particular geographical environment with its inherent natural and human factors; and (c) the production steps of which all take place in the defined geographical area. 2. For the purpose of this Regulation, \u2018geographical indication\u2019 is a name which identifies a product: (a) originating in a specific place, region or country; (b) whose given quality, reputation or other characteristic is essentially attributable to its geographical origin; and (c) at least one of the production steps of which take place in the defined geographical area. 3. Notwithstanding paragraph 1, certain names shall be treated as designations of origin even though the raw materials for the products concerned come from a geographical area larger than, or different from, the defined geographical area, provided that: (a) the production area of the raw materials is defined; (b) special conditions for the production of the raw materials exist; (c) there are control arrangements to ensure that the conditions referred to in point (b) are adhered to; and (d) the designations of origin in question were recognised as designations of origin in the country of origin before 1 May 2004. Only live animals, meat and milk may be considered as raw materials for the purposes of this paragraph. 4. In order to take into account the specific character of production of products of animal origin, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning restrictions and derogations with regard to the sourcing of feed in the case of a designation of origin. In addition, in order to take into account the specific character of certain products or areas, the Commission shall be empowered to adopt delegated acts in accordance with Article 56, concerning restrictions and derogations with regard to the slaughtering of live animals or with regard to the sourcing of raw materials. These restrictions and derogations shall, based on objective criteria, take into account quality or usage and recognised know-how or natural factors. Article 6 Generic nature, conflicts with names of plant varieties and animal breeds, with homonyms and trade marks 1. Generic terms shall not be registered as protected designations of origin or protected geographical indications. 2. A name may not be registered as a designation of origin or geographical indication where it conflicts with a name of a plant variety or an animal breed and is likely to mislead the consumer as to the true origin of the product. 3. A name proposed for registration that is wholly or partially homonymous with a name already entered in the register established under Article 11 may not be registered unless there is sufficient distinction in practice between the conditions of local and traditional usage and presentation of the homonym registered subsequently and the name already entered in the register, taking into account the need to ensure equitable treatment of the producers concerned and that consumers are not misled. A homonymous name which misleads the consumer into believing that products come from another territory shall not be registered even if the name is accurate as far as the actual territory, region or place of origin of the products in question is concerned. 4. A name proposed for registration as a designation of origin or geographical indication shall not be registered where, in the light of a trade mark\u2019s reputation and renown and the length of time it has been used, registration of the name proposed as the designation of origin or geographical indication would be liable to mislead the consumer as to the true identity of the product. Article 7 Product specification 1. A protected designation of origin or a protected geographical indication shall comply with a specification which shall include at least: (a) the name to be protected as a designation of origin or geographical indication, as it is used, whether in trade or in common language, and only in the languages which are or were historically used to describe the specific product in the defined geographical area; (b) a description of the product, including the raw materials, if appropriate, as well as the principal physical, chemical, microbiological or organoleptic characteristics of the product; (c) the definition of the geographical area delimited with regard to the link referred to in point (f)(i) or (ii) of this paragraph, and, where appropriate, details indicating compliance with the requirements of Article 5(3); (d) evidence that the product originates in the defined geographical area referred to in Article 5(1) or (2); (e) a description of the method of obtaining the product and, where appropriate, the authentic and unvarying local methods as well as information concerning packaging, if the applicant group so determines and gives sufficient product-specific justification as to why the packaging must take place in the defined geographical area to safeguard quality, to ensure the origin or to ensure control, taking into account Union law, in particular that on the free movement of goods and the free provision of services; (f) details establishing the following: (i) the link between the quality or characteristics of the product and the geographical environment referred to in Article 5(1); or (ii) where appropriate, the link between a given quality, the reputation or other characteristic of the product and the geographical origin referred to in Article 5(2); (g) the name and address of the authorities or, if available, the name and address of bodies verifying compliance with the provisions of the product specification pursuant to Article 37 and their specific tasks; (h) any specific labelling rule for the product in question. 2. In order to ensure that product specifications provide relevant and succinct information, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down rules which limit the information contained in the specification referred to in paragraph 1 of this Article, where such a limitation is necessary to avoid excessively voluminous applications for registration. The Commission may adopt implementing acts laying down rules on the form of the specification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 8 Content of application for registration 1. An application for registration of a designation of origin or geographical indication pursuant to Article 49(2) or (5) shall include at least: (a) the name and address of the applicant group and of the authorities or, if available, bodies verifying compliance with the provisions of the product specification; (b) the product specification provided for in Article 7; (c) a single document setting out the following: (i) the main points of the product specification: the name, a description of the product, including, where appropriate, specific rules concerning packaging and labelling, and a concise definition of the geographical area; (ii) a description of the link between the product and the geographical environment or geographical origin referred to in Article 5(1) or (2), as the case may be, including, where appropriate, the specific elements of the product description or production method justifying the link. An application as referred to in Article 49(5) shall, in addition, include proof that the name of the product is protected in its country of origin. 2. An application dossier referred to in Article 49(4) shall comprise: (a) the name and address of the applicant group; (b) the single document referred to in point (c) of paragraph 1 of this Article; (c) a declaration by the Member State that it considers that the application lodged by the applicant group and qualifying for the favourable decision meets the conditions of this Regulation and the provisions adopted pursuant thereto; (d) the publication reference of the product specification. Article 9 Transitional national protection A Member State may, on a transitional basis only, grant protection to a name under this Regulation at national level, with effect from the date on which an application is lodged with the Commission. Such national protection shall cease on the date on which either a decision on registration under this Regulation is taken or the application is withdrawn. Where a name is not registered under this Regulation, the consequences of such national protection shall be the sole responsibility of the Member State concerned. The measures taken by Member States under the first paragraph shall produce effects at national level only, and they shall have no effect on intra-Union or international trade. Article 10 Grounds for opposition 1. A reasoned statement of opposition as referred to in Article 51(2) shall be admissible only if it is received by the Commission within the time limit set out in that paragraph and if it: (a) shows that the conditions referred to in Article 5 and Article 7(1) are not complied with; (b) shows that the registration of the name proposed would be contrary to Article 6(2), (3) or (4); (c) shows that the registration of the name proposed would jeopardise the existence of an entirely or partly identical name or of a trade mark or the existence of products which have been legally on the market for at least five years preceding the date of the publication provided for in point (a) of Article 50(2); or (d) gives details from which it can be concluded that the name for which registration is requested is a generic term. 2. The grounds for opposition shall be assessed in relation to the territory of the Union. Article 11 Register of protected designations of origin and protected geographical indications 1. The Commission shall adopt implementing acts, without applying the procedure referred to in Article 57(2), establishing and maintaining a publicly accessible updated register of protected designations of origin and protected geographical indications recognised under this scheme. 2. Geographical indications pertaining to products of third countries that are protected in the Union under an international agreement to which the Union is a contracting party may be entered in the register. Unless specifically identified in the said agreement as protected designations of origin under this Regulation, such names shall be entered in the register as protected geographical indications. 3. The Commission may adopt implementing acts laying down detailed rules on the form and content of the register. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). 4. The Commission shall make public and regularly update the list of the international agreements referred to in paragraph 2 as well as the list of geographical indications protected under those agreements. Article 12 Names, symbols and indications 1. Protected designations of origin and protected geographical indications may be used by any operator marketing a product conforming to the corresponding specification. 2. Union symbols designed to publicise protected designations of origin and protected geographical indications shall be established. 3. In the case of products originating in the Union that are marketed under a protected designation of origin or a protected geographical indication registered in accordance with the procedures laid down in this Regulation, the Union symbols associated with them shall appear on the labelling. In addition, the registered name of the product should appear in the same field of vision. The indications \u2018protected designation of origin\u2019 or \u2018protected geographical indication\u2019 or the corresponding abbreviations \u2018PDO\u2019 or \u2018PGI\u2019 may appear on the labelling. 4. In addition, the following may also appear on the labelling: depictions of the geographical area of origin, as referred to in Article 5, and text, graphics or symbols referring to the Member State and/or region in which that geographical area of origin is located. 5. Without prejudice to Directive 2000/13/EC, the collective geographical marks referred to in Article 15 of Directive 2008/95/EC may be used on labels, together with the protected designation of origin or protected geographical indication. 6. In the case of products originating in third countries marketed under a name entered in the register, the indications referred to in paragraph 3 or the Union symbols associated with them may appear on the labelling. 7. In order to ensure that the appropriate information is communicated to the consumer, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, establishing the Union symbols. The Commission may adopt implementing acts defining the technical characteristics of the Union symbols and indications as well as the rules of their use on the products marketed under a protected designation of origin or a protected geographical indication, including rules concerning the appropriate linguistic versions to be used. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 13 Protection 1. Registered names shall be protected against: (a) any direct or indirect commercial use of a registered name in respect of products not covered by the registration where those products are comparable to the products registered under that name or where using the name exploits the reputation of the protected name, including when those products are used as an ingredient; (b) any misuse, imitation or evocation, even if the true origin of the products or services is indicated or if the protected name is translated or accompanied by an expression such as \u2018style\u2019, \u2018type\u2019, \u2018method\u2019, \u2018as produced in\u2019, \u2018imitation\u2019 or similar, including when those products are used as an ingredient; (c) any other false or misleading indication as to the provenance, origin, nature or essential qualities of the product that is used on the inner or outer packaging, advertising material or documents relating to the product concerned, and the packing of the product in a container liable to convey a false impression as to its origin; (d) any other practice liable to mislead the consumer as to the true origin of the product. Where a protected designation of origin or a protected geographical indication contains within it the name of a product which is considered to be generic, the use of that generic name shall not be considered to be contrary to points (a) or (b) of the first subparagraph. 2. Protected designations of origin and protected geographical indications shall not become generic. 3. Member States shall take appropriate administrative and judicial steps to prevent or stop the unlawful use of protected designations of origin and protected geographical indications, as referred to in paragraph 1, that are produced or marketed in that Member State. To that end Member States shall designate the authorities that are responsible for taking these steps in accordance with procedures determined by each individual Member State. These authorities shall offer adequate guarantees of objectivity and impartiality, and shall have at their disposal the qualified staff and resources necessary to carry out their functions. Article 14 Relations between trade marks, designations of origin and geographical indications 1. Where a designation of origin or a geographical indication is registered under this Regulation, the registration of a trade mark the use of which would contravene Article 13(1) and which relates to a product of the same type shall be refused if the application for registration of the trade mark is submitted after the date of submission of the registration application in respect of the designation of origin or the geographical indication to the Commission. Trade marks registered in breach of the first subparagraph shall be invalidated. The provisions of this paragraph shall apply notwithstanding the provisions of Directive 2008/95/EC. 2. Without prejudice to Article 6(4), a trade mark the use of which contravenes Article 13(1) which has been applied for, registered, or established by use if that possibility is provided for by the legislation concerned, in good faith within the territory of the Union, before the date on which the application for protection of the designation of origin or geographical indication is submitted to the Commission, may continue to be used and renewed for that product notwithstanding the registration of a designation of origin or geographical indication, provided that no grounds for its invalidity or revocation exist under Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (22) or under Directive 2008/95/EC. In such cases, the use of the protected designation of origin or protected geographical indication shall be permitted as well as use of the relevant trade marks. Article 15 Transitional periods for use of protected designations of origin and protected geographical indications 1. Without prejudice to Article 14, the Commission may adopt implementing acts granting a transitional period of up to five years to enable products originating in a Member State or a third country the designation of which consists of or contains a name that contravenes Article 13(1) to continue to use the designation under which it was marketed on condition that an admissible statement of opposition under Article 49(3) or Article 51 shows that: (a) the registration of the name would jeopardise the existence of an entirely or partly identical name; or (b) such products have been legally marketed with that name in the territory concerned for at least five years preceding the date of the publication provided for point (a) of Article 50(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). 2. Without prejudice to Article 14, the Commission may adopt implementing acts extending the transitional period mentioned in paragraph 1 of this Article to 15 years in duly justified cases where it is shown that: (a) the designation referred to in paragraph 1 of this Article has been in legal use consistently and fairly for at least 25 years before the application for registration was submitted to the Commission; (b) the purpose of using the designation referred to in paragraph 1 of this Article has not, at any time, been to profit from the reputation of the registered name and it is shown that the consumer has not been nor could have been misled as to the true origin of the product. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). 3. When using a designation referred to in paragraphs 1 and 2, the indication of country of origin shall clearly and visibly appear on the labelling. 4. To overcome temporary difficulties with the long-term objective of ensuring that all producers in the area concerned comply with the specification, a Member State may grant a transitional period of up to 10 years, with effect from the date on which the application is lodged with the Commission, on condition that the operators concerned have legally marketed the products in question, using the names concerned continuously for at least the five years prior to the lodging of the application to the authorities of the Member State and have made that point in the national opposition procedure referred to in Article 49(3). The first subparagraph shall apply mutatis mutandis to a protected geographical indication or protected designation of origin referring to a geographical area situated in a third country, with the exception of the opposition procedure. Such transitional periods shall be indicated in the application dossier referred to in Article 8(2). Article 16 Transitional provisions 1. Names entered in the register provided for in Article 7(6) of Regulation (EC) No 510/2006 shall automatically be entered in the register referred to in Article 11 of this Regulation. The corresponding specifications shall be deemed to be the specifications referred to in Article 7 of this Regulation. Any specific transitional provisions associated with such registrations shall continue to apply. 2. In order to protect the rights and legitimate interests of producers or stakeholders concerned, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning additional transitional rules. 3. This Regulation shall apply without prejudice to any right of coexistence recognised under Regulation (EC) No 510/2006 in respect of designations of origin and geographical indications, on the one hand, and trade marks, on the other. TITLE III TRADITIONAL SPECIALITIES GUARANTEED Article 17 Objective A scheme for traditional specialities guaranteed is established to safeguard traditional methods of production and recipes by helping producers of traditional product in marketing and communicating the value-adding attributes of their traditional recipes and products to consumers. Article 18 Criteria 1. A name shall be eligible for registration as a traditional speciality guaranteed where it describes a specific product or foodstuff that: (a) results from a mode of production, processing or composition corresponding to traditional practice for that product or foodstuff; or (b) is produced from raw materials or ingredients that are those traditionally used. 2. For a name to be registered as a traditional speciality guaranteed, it shall: (a) have been traditionally used to refer to the specific product; or (b) identify the traditional character or specific character of the product. 3. If it is demonstrated in the opposition procedure under Article 51 that the name is also used in another Member State or in a third country, in order to distinguish comparable products or products that share an identical or similar name, the decision on registration taken in accordance with Article 52(3) may provide that the name of the traditional speciality guaranteed is to be accompanied by the claim \u2018made following the tradition of\u2019 immediately followed by the name of a country or a region thereof. 4. A name may not be registered if it refers only to claims of a general nature used for a set of products, or to claims provided for by particular Union legislation. 5. In order to ensure the smooth functioning of the scheme, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning further details of the eligibility criteria laid down in this Article. Article 19 Product specification 1. A traditional speciality guaranteed shall comply with a specification which shall comprise: (a) the name proposed for registration, in the appropriate language versions; (b) a description of the product including its main physical, chemical, microbiological or organoleptic characteristics, showing the product\u2019s specific character; (c) a description of the production method that the producers must follow, including, where appropriate, the nature and characteristics of the raw materials or ingredients used, and the method by which the product is prepared; and (d) the key elements establishing the product\u2019s traditional character. 2. In order to ensure that product specifications provide relevant and succinct information, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down rules which limit the information contained in the specification referred to in paragraph 1 of this Article, where such a limitation is necessary to avoid excessively voluminous applications for registration. The Commission may adopt implementing acts laying down rules on the form of the specification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 20 Content of application for registration 1. An application for registration of a name as a traditional speciality guaranteed referred to in Article 49(2) or (5) shall comprise: (a) the name and address of the applicant group; (b) the product specification as provided for in Article 19. 2. An application dossier referred to in Article 49(4) shall comprise: (a) the elements referred to in paragraph 1 of this Article; and (b) a declaration by the Member State that it considers that the application lodged by the group and qualifying for the favourable decision meets the conditions of this Regulation and the provisions adopted pursuant thereto. Article 21 Grounds for opposition 1. A reasoned statement of opposition as referred to in Article 51(2) shall be admissible only if it is received by the Commission before expiry of the time limit and if it: (a) gives duly substantiated reasons why the proposed registration is incompatible with the terms of this Regulation; or (b) shows that use of the name is lawful, renowned and economically significant for similar agricultural products or foodstuffs. 2. The criteria referred to in point (b) of paragraph 1 shall be assessed in relation to the territory of the Union. Article 22 Register of traditional specialities guaranteed 1. The Commission shall adopt implementing acts, without applying the procedure referred to in Article 57(2), establishing and maintaining a publicly accessible updated register of traditional specialties guaranteed recognised under this scheme. 2. The Commission may adopt implementing acts laying down detailed rules on the form and content of the register. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 23 Names, symbol and indication 1. A name registered as a traditional speciality guaranteed may be used by any operator marketing a product that conforms to the corresponding specification. 2. A Union symbol shall be established in order to publicise the traditional specialities guaranteed. 3. In the case of the products originating in the Union that are marketed under a traditional speciality guaranteed that is registered in accordance with this Regulation, the symbol referred to in paragraph 2 shall, without prejudice to paragraph 4, appear on the labelling. In addition, the name of the product should appear in the same field of vision. The indication \u2018traditional speciality guaranteed\u2019 or the corresponding abbreviation \u2018TSG\u2019 may also appear on the labelling. The symbol shall be optional on the labelling of traditional specialities guaranteed which are produced outside the Union. 4. In order to ensure that the appropriate information is communicated to the consumer, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, establishing the Union symbol. The Commission may adopt implementing acts defining the technical characteristics of the Union symbol and indication, as well as the rules of their use on the products bearing the name of a traditional speciality guaranteed, including as to the appropriate linguistic versions to be used. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 24 Restriction on use of registered names 1. Registered names shall be protected against any misuse, imitation or evocation, or against any other practice liable to mislead the consumer. 2. Member States shall ensure that sales descriptions used at national level do not give rise to confusion with names that are registered. 3. The Commission may adopt implementing acts laying down rules for the protection of traditional specialities guaranteed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 25 Transitional provisions 1. Names registered in accordance with Article 13(2) of Regulation (EC) No 509/2006 shall be automatically entered in the register referred to in Article 22 of this Regulation. The corresponding specifications shall be deemed to be the specifications referred to in Article 19 of this Regulation. Any specific transitional provisions associated with such registrations shall continue to apply. 2. Names registered in accordance with the requirements laid down in Article 13(1) of Regulation (EC) No 509/2006, including those registered pursuant to applications referred to in the second subparagraph of Article 58(1) of this Regulation, may continue to be used under the conditions provided for in Regulation (EC) No 509/2006 until 4 January 2023 unless Member States use the procedure set out in Article 26 of this Regulation. 3. In order to protect the rights and legitimate interests of producers or stakeholders concerned, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down additional transitional rules. Article 26 Simplified procedure 1. At the request of a group, a Member State may submit, no later than 4 January 2016, to the Commission names of traditional specialities guaranteed that are registered in accordance with Article 13(1) of Regulation (EC) No 509/2006 and that comply with this Regulation. Before submitting a name, the Member State shall initiate an opposition procedure as defined in Article 49(3) and (4). If it is demonstrated in the course of this procedure that the name is also used in reference to comparable products or products that share an identical or similar name, the name may be complemented by a term identifying its traditional or specific character. A group from a third country may submit such names to the Commission, either directly or through the authorities of the third country. 2. The Commission shall publish the names referred to in paragraph 1 together with the specifications for each such name in the Official Journal of the European Union within two months from reception. 3. Articles 51 and 52 shall apply. 4. Once the opposition procedure has finished, the Commission shall, where appropriate, adjust the entries in the register set out in Article 22. The corresponding specifications shall be deemed to be the specifications referred to in Article 19. TITLE IV OPTIONAL QUALITY TERMS Article 27 Objective A scheme for optional quality terms is established in order to facilitate the communication within the internal market of the value-adding characteristics or attributes of agricultural products by the producers thereof. Article 28 National Rules Member States may maintain national rules on optional quality terms which are not covered by this Regulation, provided that such rules comply with Union law. Article 29 Optional quality terms 1. Optional quality terms shall satisfy the following criteria: (a) the term relates to a characteristic of one or more categories of products, or to a farming or processing attribute which applies in specific areas; (b) the use of the term adds value to the product as compared to products of a similar type; and (c) the term has a European dimension. 2. Optional quality terms that describe technical product qualities with the purpose of putting into effect compulsory marketing standards and are not intended to inform consumers about those product qualities shall be excluded from this scheme. 3. Optional quality terms shall exclude optional reserved terms which support and complement specific marketing standards determined on a sectoral or product category basis. 4. In order to take into account the specific character of certain sectors as well as consumer expectations, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down detailed rules relating to the criteria referred to in paragraph 1 of this Article. 5. The Commission may adopt implementing acts laying down all measures related to forms, procedures or other technical details, necessary for the application of this Title. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). 6. When adopting delegated and implementing acts in accordance with paragraphs 4 and 5 of this Article, the Commission shall take account of any relevant international standards. Article 30 Reservation and amendment 1. In order to take account of the expectations of consumers, developments in scientific and technical knowledge, the market situation, and developments in marketing standards and in international standards, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, reserving an additional optional quality term and laying down its conditions of use. 2. In duly justified cases and in order to take into account the appropriate use of the additional optional quality term, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down amendments to the conditions of use referred to in paragraph 1 of this Article. Article 31 Mountain product 1. The term \u2018mountain product\u2019 is established as an optional quality term. This term shall only be used to describe products intended for human consumption listed in Annex I to the Treaty in respect of which: (a) both the raw materials and the feedstuffs for farm animals come essentially from mountain areas; (b) in the case of processed products, the processing also takes place in mountain areas. 2. For the purposes of this Article, mountain areas within the Union are those delimited pursuant to Article 18(1) of Regulation (EC) No 1257/1999. For third-country products, mountain areas include areas officially designated as mountain areas by the third country or that meet criteria equivalent to those set out in Article 18(1) of Regulation (EC) No 1257/1999. 3. In duly justified cases and in order to take into account natural constraints affecting agricultural production in mountain areas, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down derogations from the conditions of use referred to in paragraph 1 of this Article. In particular, the Commission shall be empowered to adopt a delegated act laying down the conditions under which raw materials or feedstuffs are permitted to come from outside the mountain areas, the conditions under which the processing of products is permitted to take place outside of the mountain areas in a geographical area to be defined, and the definition of that geographical area. 4. In order to take into account natural constraints affecting agricultural production in mountain areas, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning the establishment of the methods of production, and other criteria relevant for the application of the optional quality term established in paragraph 1 of this Article. Article 32 Product of island farming No later than 4 January 2014 the Commission shall present a report to the European Parliament and to the Council on the case for a new term, \u2018product of island farming\u2019. The term may only be used to describe the products intended for human consumption that are listed in Annex I to the Treaty the raw materials of which come from islands. In addition, for the term to be applied to processed products, processing must also take place on islands in cases where this substantially affects the particular characteristics of the final product. That report shall, if necessary, be accompanied by appropriate legislative proposals to reserve an optional quality term \u2018product of island farming\u2019. Article 33 Restrictions on use 1. An optional quality term may only be used to describe products that comply with the corresponding conditions of use. 2. The Commission may adopt implementing acts laying down rules for the use of optional quality terms. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 34 Monitoring Member States shall undertake checks, based on a risk analysis, to ensure compliance with the requirements of this Title and, in the event of breach, shall apply appropriate administrative penalties. TITLE V COMMON PROVISIONS CHAPTER I Official controls of protected designations of origin, protected geographical indications and traditional specialities guaranteed Article 35 Scope The provisions of this Chapter shall apply in respect of the quality schemes set out in Title II and Title III. Article 36 Designation of competent authority 1. In accordance with Regulation (EC) No 882/2004, Member States shall designate the competent authority or authorities responsible for official controls carried out to verify compliance with the legal requirements related to the quality schemes established by this Regulation. Procedures and requirements of Regulation (EC) No 882/2004 shall apply mutatis mutandis to the official controls carried out to verify compliance with the legal requirement related to the quality schemes for all products covered by Annex I to this Regulation. 2. The competent authorities referred to in paragraph 1 shall offer adequate guarantees of objectivity and impartiality, and shall have at their disposal the qualified staff and resources necessary to carry out their functions. 3. Official controls shall cover: (a) verification that a product complies with the corresponding product specification; and (b) monitoring of the use of registered names to describe product placed on the market, in conformity with Article 13 for names registered under Title II and in conformity with Article 24 for names registered under Title III. Article 37 Verification of compliance with product specification 1. In respect of protected designations of origin, protected geographical indications and traditional specialities guaranteed that designate products originating within the Union, verification of compliance with the product specification, before placing the product on the market, shall be carried out by: (a) one or more of the competent authorities as referred to in Article 36 of this Regulation; and/or (b) one or more of the control bodies within the meaning of point (5) of Article 2 of Regulation (EC) No 882/2004 operating as a product certification body. The costs of such verification of compliance with the specifications may be borne by the operators that are subject to those controls. The Member States may also contribute to these costs. 2. In respect of designations of origin, geographical indications and traditional specialities guaranteed that designate products originating in a third country, the verification of compliance with the specifications before placing the product on the market shall be carried out by: (a) one or more of the public authorities designated by the third country; and/or (b) one or more of the product certification bodies. 3. Member States shall make public the name and address of the authorities and bodies referred to paragraph 1 of this Article, and update that information periodically. The Commission shall make public the name and address of the authorities and bodies referred to in paragraph 2 of this Article and update that information periodically. 4. The Commission may adopt implementing acts, without applying the procedure referred to in Article 57(2), defining the means by which the name and address of product certification bodies referred to in paragraphs 1 and 2 of this Article shall be made public. Article 38 Surveillance of the use of the name in the market place Member States shall inform the Commission of the names and addresses of the competent authorities referred to in Article 36. The Commission shall make public the names and addresses of those authorities. Member States shall carry out checks, based on a risk analysis, to ensure compliance with the requirements of this Regulation and, in the event of breaches, Member States shall take all necessary measures. Article 39 Delegation by competent authorities to control bodies 1. Competent authorities may delegate, in accordance with Article 5 of Regulation (EC) No 882/2004, specific tasks related to official controls of the quality schemes to one or more control bodies. 2. Such control bodies shall be accredited in accordance with European Standard EN 45011 or ISO/IEC Guide 65 (General requirements for bodies operating product certification systems). 3. Accreditation referred to in paragraph 2 of this Article may only be performed by: (a) a national accreditation body in the Union in accordance with the provisions of Regulation (EC) No 765/2008; or (b) an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum. Article 40 Planning and reporting of control activities 1. Member States shall ensure that activities for the control of obligations under this Chapter are specifically included in a separate section within the multi-annual national control plans in accordance with Articles 41, 42 and 43 of Regulation (EC) No 882/2004. 2. The annual reports concerning the control of the obligations established by this Regulation shall include a separate section comprising the information laid down in Article 44 of Regulation (EC) No 882/2004. CHAPTER II Exceptions for certain prior uses Article 41 Generic terms 1. Without prejudice to Article 13, this Regulation shall not affect the use of terms that are generic in the Union, even if the generic term is part of a name that is protected under a quality scheme. 2. To establish whether or not a term has become generic, account shall be taken of all relevant factors, in particular: (a) the existing situation in areas of consumption; (b) the relevant national or Union legal acts. 3. In order to fully protect the rights of interested parties, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down additional rules for determining the generic status of terms referred to in paragraph 1 of this Article. Article 42 Plant varieties and animal breeds 1. This Regulation shall not prevent the placing on the market of products the labelling of which includes a name or term protected or reserved under a quality scheme described in Title II, Title III, or Title IV that contains or comprises the name of a plant variety or animal breed, provided that the following conditions are met: (a) the product in question comprises or is derived from the variety or breed indicated; (b) consumers are not misled; (c) the usage of the name of the variety or breed name constitutes fair competition; (d) the usage does not exploit the reputation of the protected term; and (e) in the case of the quality scheme described in Title II, production and marketing of the product had spread beyond its area of origin prior to the date of application for registration of the geographical indication. 2. In order to further clarify the extent of rights and freedoms of food business operators to use the name of a plant variety or of an animal breed referred to in paragraph 1 of this Article, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning rules for determining the use of such names. Article 43 Relation to intellectual property The quality schemes described in Titles III and IV shall apply without prejudice to Union rules or to those of Member States governing intellectual property, and in particular to those concerning designations of origin and geographical indications and trade marks, and rights granted under those rules. CHAPTER III Quality scheme indications and symbols and role of producers Article 44 Protection of indications and symbols 1. Indications, abbreviations and symbols referring to the quality schemes may only be used in connection with products produced in conformity with the rules of the quality scheme to which they apply. This applies in particular to the following indications, abbreviations and symbols: (a) \u2018protected designation of origin\u2019, \u2018protected geographical indication\u2019, \u2018geographical indication\u2019, \u2018PDO\u2019, \u2018PGI\u2019, and the associated symbols, as provided for in Title II; (b) \u2018traditional speciality guaranteed\u2019, \u2018TSG\u2019, and the associated symbol, as provided for in Title III; (c) \u2018mountain product\u2019, as provided for in Title IV. 2. In accordance with Article 5 of Regulation (EC) No 1290/2005, the European Agricultural Fund for Rural Development (EAFRD) may, on the initiative of the Commission or on its behalf, finance, on a centralised basis, administrative support concerning the development, preparatory work, monitoring, administrative and legal support, legal defence, registration fees, renewal fees, trade mark watching fees, litigation fees and any other related measure required to protect the use of the indications, abbreviations and symbols referring to the quality schemes from misuse, imitation, evocation or any other practice liable to mislead the consumer, within the Union and in third countries. 3. The Commission shall adopt implementing acts laying down rules for the uniform protection of the indications, abbreviations and symbols referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 45 Role of groups 1. Without prejudice to specific provisions on producer organisations and inter-branch organisations as laid down in Regulation (EC) No 1234/2007, a group is entitled to: (a) contribute to ensuring that the quality, reputation and authenticity of their products are guaranteed on the market by monitoring the use of the name in trade and, if necessary, by informing competent authorities as referred to in Article 36, or any other competent authority within the framework of Article 13(3); (b) take action to ensure adequate legal protection of the protected designation of origin or protected geographical indication and of the intellectual property rights that are directly connected with them; (c) develop information and promotion activities aiming at communicating the value-adding attributes of the product to consumers; (d) develop activities related to ensuring compliance of a product with its specification; (e) take action to improve the performance of the scheme, including developing economic expertise, carrying out economic analyses, disseminating economic information on the scheme and providing advice to producers; (f) take measures to enhance the value of products and, where necessary, take steps to prevent or counter any measures which are, or risk being, detrimental to the image of those products. 2. Member States may encourage the formation and functioning of groups on their territories by administrative means. Moreover, Member States shall communicate to the Commission the name and address of the groups referred to in point 2 of Article 3. The Commission shall make this information public. Article 46 Right to use the schemes 1. Member States shall ensure that any operator complying with the rules of a quality scheme set out in Titles II and III is entitled to be covered by the verification of compliance established pursuant to Article 37. 2. Operators who prepare and store a product marketed under the traditional speciality guaranteed, protected designation of origin or protected geographical indication schemes or who place such products on the market shall also be subject to the controls laid down in Chapter I of this Title. 3. Member States shall ensure that operators willing to adhere to the rules of a quality scheme set out in Titles III and IV are able to do so and do not face obstacles to participation that are discriminatory or otherwise not objectively founded. Article 47 Fees Without prejudice to Regulation (EC) No 882/2004 and in particular the provisions of Chapter VI of Title II thereof, Member States may charge a fee to cover their costs of managing the quality schemes, including those incurred in processing applications, statements of opposition, applications for amendments and requests for cancellations provided for in this Regulation. CHAPTER IV Application and registration processes for designations of origin, geographical indications, and traditional specialities guaranteed Article 48 Scope of application processes The provisions of this Chapter shall apply in respect of the quality schemes set out in Title II and Title III. Article 49 Application for registration of names 1. Applications for registration of names under the quality schemes referred to in Article 48 may only be submitted by groups who work with the products with the name to be registered. In the case of a \u2018protected designations of origin\u2019 or \u2018protected geographical indications\u2019 name that designates a trans-border geographical area or in the case of a \u2018traditional specialities guaranteed\u2019 name, several groups from different Member States or third countries may lodge a joint application for registration. A single natural or legal person may be treated as a group where it is shown that both of the following conditions are fulfilled: (a) the person concerned is the only producer willing to submit an application; (b) with regard to protected designations of origin and protected geographical indications, the defined geographical area possesses characteristics which differ appreciably from those of neighbouring areas or the characteristics of the product are different from those produced in neighbouring areas. 2. Where the application under the scheme set out in Title II relates to a geographical area in a Member State, or where an application under the scheme set out in Title III is prepared by a group established in a Member State, the application shall be addressed to the authorities of that Member State. The Member State shall scrutinise the application by appropriate means in order to check that it is justified and meets the conditions of the respective scheme. 3. As part of the scrutiny referred to in the second subparagraph of paragraph 2 of this Article, the Member State shall initiate a national opposition procedure that ensures adequate publication of the application and that provides for a reasonable period within which any natural or legal person having a legitimate interest and established or resident on its territory may lodge an opposition to the application. The Member State shall examine the admissibility of oppositions received under the scheme set out in Title II in the light of the criteria referred to in Article 10(1), or the admissibility of oppositions received under the scheme set out in Title III in the light of the criteria referred to in Article 21(1). 4. If, after assessment of any opposition received, the Member State considers that the requirements of this Regulation are met, it may take a favourable decision and lodge an application dossier with the Commission. It shall in such case inform the Commission of admissible oppositions received from a natural or legal person that have legally marketed the products in question, using the names concerned continuously for at least five years preceding the date of the publication referred to in paragraph 3. The Member State shall ensure that its favourable decision is made public and that any natural or legal person having a legitimate interest has an opportunity to appeal. The Member State shall ensure that the version of the product specification on which its favourable decision is based, is published, and shall provide electronic access to the product specification. With reference to protected designations of origin and protected geographical indications, the Member State shall also ensure adequate publication of the version of the product specification on which the Commission takes its decision pursuant to Article 50(2). 5. Where the application under the scheme set out in Title II relates to a geographical area in a third country, or where an application under the scheme set out in Title III is prepared by a group established in a third country, the application shall be lodged with the Commission, either directly or via the authorities of the third country concerned. 6. The documents referred to in this Article which are sent to the Commission shall be in one of the official languages of the Union. 7. In order to facilitate the application process, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, defining the rules for carrying out the national objection procedure for joint applications concerning more than one national territory and complementing the rules of the application process. The Commission may adopt implementing acts laying down detailed rules on procedures, form and presentation of applications, including for applications concerning more than one national territory. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 50 Scrutiny by the Commission and publication for opposition 1. The Commission shall scrutinise by appropriate means any application that it receives pursuant to Article 49, in order to check that it is justified and that it meets the conditions of the respective scheme. This scrutiny should not exceed a period of six months. Where this period is exceeded, the Commission shall indicate in writing to the applicant the reasons for the delay. The Commission shall, at least each month, make public the list of names for which registration applications have been submitted to it, as well as their date of submission. 2. Where, based on the scrutiny carried out pursuant to the first subparagraph of paragraph 1, the Commission considers that the conditions laid down in this Regulation are fulfilled, it shall publish in the Official Journal of the European Union: (a) for applications under the scheme set out in Title II, the single document and the reference to the publication of the product specification; (b) for applications under the scheme set out in Title III, the specification. Article 51 Opposition procedure 1. Within three months from the date of publication in the Official Journal of the European Union, the authorities of a Member State or of a third country, or a natural or legal person having a legitimate interest and established in a third country may lodge a notice of opposition with the Commission. Any natural or legal person having a legitimate interest, established or resident in a Member State other than that from which the application was submitted, may lodge a notice of opposition with the Member State in which it is established within a time limit permitting an opposition to be lodged pursuant to the first subparagraph. A notice of opposition shall contain a declaration that the application might infringe the conditions laid down in this Regulation. A notice of opposition that does not contain this declaration is void. The Commission shall forward the notice of opposition to the authority or body that lodged the application without delay. 2. If a notice of opposition is lodged with the Commission and is followed within two months by a reasoned statement of opposition, the Commission shall check the admissibility of this reasoned statement of opposition. 3. Within two months after the receipt of an admissible reasoned statement of opposition, the Commission shall invite the authority or person that lodged the opposition and the authority or body that lodged the application to engage in appropriate consultations for a reasonable period that shall not exceed three months. The authority or person that lodged the opposition and the authority or body that lodged the application shall start such appropriate consultations without undue delay. They shall provide each other with the relevant information to assess whether the application for registration complies with the conditions of this Regulation. If no agreement is reached, this information shall also be provided to the Commission. At any time during these three months, the Commission may, at the request of the applicant extend the deadline for the consultations by a maximum of three months. 4. Where, following the appropriate consultations referred to in paragraph 3 of this Article, the details published in accordance with Article 50(2) have been substantially amended, the Commission shall repeat the scrutiny referred to in Article 50. 5. The notice of opposition, the reasoned statement of opposition and the related documents which are sent to the Commission in accordance with paragraphs 1 to 4 of this Article shall be in one of the official languages of the Union. 6. In order to establish clear procedures and deadlines for opposition, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, complementing the rules of the opposition procedure. The Commission may adopt implementing acts laying down detailed rules on procedures, form and presentation of the oppositions. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 52 Decision on registration 1. Where, on the basis of the information available to the Commission from the scrutiny carried out pursuant to the first subparagraph of Article 50(1), the Commission considers that the conditions for registration are not fulfilled, it shall adopt implementing acts rejecting the application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). 2. If the Commission receives no notice of opposition or no admissible reasoned statement of opposition under Article 51, it shall adopt implementing acts, without applying the procedure referred to in Article 57(2), registering the name. 3. If the Commission receives an admissible reasoned statement of opposition, it shall, following the appropriate consultations referred to in Article 51(3), and taking into account the results thereof, either: (a) if an agreement has been reached, register the name by means of implementing acts adopted without applying the procedure referred to in Article 57(2), and, if necessary, amend the information published pursuant to Article 50(2) provided such amendments are not substantial; or (b) if an agreement has not been reached, adopt implementing acts deciding on the registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). 4. Acts of registration and decisions on rejection shall be published in the Official Journal of the European Union. Article 53 Amendment to a product specification 1. A group having a legitimate interest may apply for approval of an amendment to a product specification. Applications shall describe and give reasons for the amendments requested. 2. Where the amendment involves one or more amendments to the specification that are not minor, the amendment application shall follow the procedure laid down in Articles 49 to 52. However, if the proposed amendments are minor, the Commission shall approve or reject the application. In the event of the approval of amendments implying a modification of the elements referred to in Article 50(2), the Commission shall publish those elements in the Official Journal of the European Union. For an amendment to be regarded as minor in the case of the quality scheme described in Title II, it shall not: (a) relate to the essential characteristics of the product; (b) alter the link referred to in point (f)(i) or (ii) of Article 7(1); (c) include a change to the name, or to any part of the name of the product; (d) affect the defined geographical area; or (e) represent an increase in restrictions on trade in the product or its raw materials. For an amendment to be regarded as minor in the case of the quality scheme described in Title III, it shall not: (a) relate to the essential characteristics of the product; (b) introduce essential changes to the production method; or (c) include a change to the name, or to any part of the name of the product. The scrutiny of the application shall focus on the proposed amendment. 3. In order to facilitate the administrative process of an amendment application, including where the amendment does not involve any change to the single document and where it concerns a temporary change in the specification resulting from the imposition of obligatory sanitary or phytosanitary measures by the public authorities, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, complementing the rules of the amendment application process. The Commission may adopt implementing acts laying down detailed rules on procedures, form and presentation of an amendment application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 54 Cancellation 1. The Commission may, on its own initiative or at the request of any natural or legal person having a legitimate interest, adopt implementing acts to cancel the registration of a protected designation of origin or of a protected geographical indication or of a traditional speciality guaranteed in the following cases: (a) where compliance with the conditions of the specification is not ensured; (b) where no product is placed on the market under the traditional speciality guaranteed, the protected designation of origin or the protected geographical indication for at least seven years. The Commission may, at the request of the producers of product marketed under the registered name, cancel the corresponding registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). 2. In order to ensure legal certainty that all parties have the opportunity to defend their rights and legitimate interests, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56 complementing the rules regarding the cancellation process. The Commission may adopt implementing acts laying down detailed rules on procedures and form of the cancellation process, as well as on the presentation of the requests referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). TITLE VI PROCEDURAL AND FINAL PROVISIONS CHAPTER I Local farming and direct sales Article 55 Reporting on local farming and direct sales No later than 4 January 2014 the Commission shall present a report to the European Parliament and to the Council on the case for a new local farming and direct sales labelling scheme to assist producers in marketing their produce locally. That report shall focus on the ability of the farmer to add value to his produce through the new label, and should take into account other criteria, such as the possibilities of reducing carbon emissions and waste through short production and distribution chains. That report shall, if necessary, be accompanied by appropriate legislative proposals on the creation of a local farming and direct sales labelling scheme. CHAPTER II Procedural rules Article 56 Exercise of the delegation 1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) shall be conferred on the Commission for a period of five years from 3 January 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 57 Committee procedure 1. The Commission shall be assisted by the Agricultural Product Quality Policy Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. CHAPTER III Repeal and final provisions Article 58 Repeal 1. Regulations (EC) No 509/2006 and (EC) No 510/2006 are hereby repealed. However, Article 13 of Regulation (EC) No 509/2006 shall continue to apply in respect of applications concerning products falling outside the scope of Title III of this Regulation, received by the Commission prior to the date of entry into force of this Regulation. 2. References to the repealed Regulations shall be construed as references to this Regulation and be read in accordance with the correlation table in Annex II to this Regulation. Article 59 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. However, Article 12(3) and Article 23(3) shall apply from 4 January 2016, without prejudice to products already placed on the market before that date. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 21 November 2012. For the European Parliament The President M. SCHULZ For the Council The President A. D. MAVROYIANNIS (1) OJ C 218, 23.7.2011, p. 114. (2) OJ C 192, 1.7.2011, p. 28. (3) Position of the European Parliament of 13 September 2012 (not yet published in the Official Journal) and decision of the Council of 13 November 2012. (4) OJ L 149, 14.6.1991, p. 1. (5) OJ L 10, 12.1.2002, p. 47. (6) OJ L 42, 14.2.2006, p. 1. (7) OJ L 93, 31.3.2006, p. 1. (8) OJ L 93, 31.3.2006, p. 12. (9) OJ L 299, 16.11.2007, p. 1. (10) OJ L 189, 20.7.2007, p. 1. (11) OJ L 39, 13.2.2008, p. 16. (12) OJ L 109, 6.5.2000, p. 29. (13) OJ L 208, 24.7.1992, p. 1. (14) OJ L 299, 8.11.2008, p. 25. (15) OJ L 160, 26.6.1999, p. 80. (16) OJ L 165, 30.4.2004, p. 1. (17) OJ L 218, 13.8.2008, p. 30. (18) OJ L 277, 21.10.2005, p. 1. (19) OJ L 209, 11.8.2005, p. 1. (20) OJ L 55, 28.2.2011, p. 13. (21) OJ L 204, 21.7.1998, p. 37. (22) OJ L 78, 24.3.2009, p. 1. ANNEX I AGRICULTURAL PRODUCTS AND FOODSTUFFS REFERRED TO IN ARTICLE 2(1) I. Designations of Origin and Geographical indications \u2014 beer, \u2014 chocolate and derived products, \u2014 bread, pastry, cakes, confectionery, biscuits and other baker\u2019s wares, \u2014 beverages made from plant extracts, \u2014 pasta, \u2014 salt, \u2014 natural gums and resins, \u2014 mustard paste, \u2014 hay, \u2014 essential oils, \u2014 cork, \u2014 cochineal, \u2014 flowers and ornamental plants, \u2014 cotton, \u2014 wool, \u2014 wicker, \u2014 scutched flax, \u2014 leather, \u2014 fur, \u2014 feather. II. Traditional specialities guaranteed \u2014 prepared meals, \u2014 beer, \u2014 chocolate and derived products, \u2014 bread, pastry, cakes, confectionery, biscuits and other baker\u2019s wares, \u2014 beverages made from plant extracts, \u2014 pasta, \u2014 salt. ANNEX II CORRELATION TABLE REFERRED TO IN ARTICLE 58(2) Regulation (EC) No 509/2006 This Regulation Article 1(1) Article 2(1) Article 1(2) Article 2(3) Article 1(3) Article 2(4) Article 2(1), point (a) Article 3, point (5) Article 2(1), point (b) Article 3, point (3) Article 2(1), point (c) \u2014 Article 2(1), point (d) Article 3, point (2) Article 2(2), first to third subparagraph \u2014 Article 2(2), fourth subparagraph \u2014 Article 3 Article 22(1) Article 4(1), first subparagraph Article 18(1) Article 4(2) Article 18(2) Article 4(3), first subparagraph \u2014 Article 4(3), second subparagraph Article 18(4) Article 5(1) Article 43 Article 5(2) Article 42(1) Article 6(1) Article 19(1) Article 6(1), point (a) Article 19(1), point (a) Article 6(1), point (b) Article 19(1), point (b) Article 6(1), point (c) Article 19(1), point (c) Article 6(1), point (d) \u2014 Article 6(1), point (e) Article 19(1), point (d) Article 6(1), point (f) \u2014 Article 7(1) and (2) Article 49(1) Article 7(3), points (a) and (b) Article 20(1), points (a) and (b) Article 7(3), point (c) \u2014 Article 7(3), point (d) \u2014 Article 7(4) Article 49(2) Article 7(5) Article 49(3) Article 7(6), points (a), (b) and (c) Article 49(4) Article 7(6), point (d) Article 20(2) Article 7(7) Article 49(5) Article 7(8) Article 49(6) Article 8(1) Article 50(1) Article 8(2), first subparagraph Article 50(2), point (b) Article 8(2), second subparagraph Article 52(1) Article 9(1) and (2) Article 51(1) Article 9(3) Article 21(1) and (2) Article 9(4) Article 52(2) Article 9(5) Article 52(3) and (4) Article 9(6) Article 51(5) Article 10 Article 54 Article 11 Article 53 Article 12 Article 23 Article 13(1) \u2014 Article 13(2) \u2014 Article 13(3) \u2014 Article 14(1) Article 36(1) Article 14(2) Article 46(1) Article 14(3) Article 37(3), second subparagraph Article 15(1) Article 37(1) Article 15(2) Article 37(2) Article 15(3) Article 39(2) Article 15(4) Article 36(2) Article 16 \u2014 Article 17(1) and (2) Article 24(1) Article 17(3) Article 24(2) Article 18 Article 57 Article 19(1), point (a) \u2014 Article 19(1), point (b) Article 49(7), second subparagraph Article 19(1), point (c) Article 49(7), first subparagraph Article 19(1), point (d) Article 22(2) Article 19(1), point (e) Article 19(1), point (f) Article 51(6) Article 54(1) Article 19(1), point (g) Article 23(4) Article 19(1), point (h) \u2014 Article 19(1), point (i) \u2014 Article 19(2) Article 25(1) Article 19(3), point (a) \u2014 Article 19(3), point (b) Article 25(2) Article 20 Article 47 Article 21 Article 58 Article 22 Article 59 Annex I Annex I (Part II) Regulation (EC) No 510/2006 This Regulation Article 1(1) Article 2(1) and (2) Article 1(2) Article 2(3) Article 1(3) Article 2(4) Article 2 Article 5 Article 3(1), first subparagraph Article 6(1) Article 3(1), second and third subparagraph Article 41(1), (2) and (3) Article 3(2), (3) and (4) Article 6(2), (3) and (4) Article 4 Article 7 Article 5(1) Article 3, point (2), and Article 49(1) Article 5(2) Article 49(1) Article 5(3) Article 8(1) Article 5(4) Article 49(2) Article 5(5) Article 49(3) Article 5(6) Article 9 Article 5(7) Article 8(2) Article 5(8) \u2014 Article 5(9), first subparagraph \u2014 Article 5(9), second subparagraph Article 49(5) Article 5(10) Article 49(6) Article 5(11) \u2014 Article 6(1), first subparagraph Article 50(1) Article 6(2), first subparagraph Article 50(2), point (a) Article 6(2), second subparagraph Article 52(1) Article 7(1) Article 51(1), first subparagraph Article 7(2) Article 51(1), second subparagraph Article 7(3) Article 10 Article 7(4) Article 52(2) and (4) Article 7(5) Article 51(3) and Article 52(3) and (4) Article 7(6) Article 11 Article 7(7) Article 51(5) Article 8 Article 12 Article 9 Article 53 Article 10(1) Article 36(1) Article 10(2) Article 46(1) Article 10(3) Article 37(3), second subparagraph Article 11(1) Article 37(1) Article 11(2) Article 37(2) Article 11(3) Article 39(2) Article 11(4) Article 36(2) Article 12 Article 54 Article 13(1) Article 13(1) Article 13(2) Article 13(2) Article 13(3) Article 15(1) Article 13(4) Article 15(2) Article 14 Article 14 Article 15 Article 57 Article 16, point (a) Article 5(4), second subparagraph Article 16, point (b) \u2014 Article 16, point (c) \u2014 Article 16, point (d) Article 49(7) Article 16, point (e) \u2014 Article 16, point (f) Article 51(6) Article 16, point (g) Article 12(7) Article 16, point (h) \u2014 Article 16, point (i) Article 11(3) Article 16, point (j) \u2014 Article 16, point (k) Article 54(2) Article 17 Article 16 Article 18 Article 47 Article 19 Article 58 Article 20 Article 59 Annex I and Annex II Annex I (Part I)", "summary": "Enhancing quality schemes for agricultural products and foodstuffs Enhancing quality schemes for agricultural products and foodstuffs SUMMARY OF: Regulation (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs WHAT IS THE AIM OF THE REGULATION? It seeks to enhance Europe\u2019s quality policy for agricultural products by increasing the coherence of various quality schemes. It includes measures to support agricultural and processing activities, along with the farming systems associated with high-quality products, in line with EU rural development policy objectives. The regulation, does not, however, apply to spirit drinks, aromatised wines or grapevine products. KEY POINTS The regulation\u2019s main features are: it groups in a single regulation rules for registering products as Protected Designation of Origin (PDO), Protected Geographical Indication (PGI) and Traditional Speciality Guaranteed (TSG); it lays down a single set of rules for PDO, PGI and TSG as regards procedures and the role of producers; it strengthens and simplifies the PDO, PGI and TSG schemes; it reinforces and clarifies the level of protection of registered names and the common EU symbols; it shortens and simplifies the procedure to register names (PDO, PGI and TSG); it requires EU products registered and marketed as PDO, PGI or TSG in line with this regulation to have labels showing the European Union symbol and the name of the product (since 4 January 2016); it introduces a new framework to develop optional quality terms, providing consumers with extra information. This includes the new term mountain product. Amending legislation In 2017, Regulation (EU) No 1151/2012 was amended by Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products (see summary). The amended text requires that verification of compliance with product specifications before placing products on the market be carried out by: the competent authorities designated in accordance with amending Regulation (EU) 2017/625 (Article 4); or delegated bodies (as defined in Article 3(5) of amending Regulation (EU) 2017/625). Delegated bodies performing controls in non-EU countries must be accredited to the relevant harmonised standard for \u2018conformity assessment \u2014 requirements for bodies certifying products, processes and services\u2019. These bodies may be accredited either by a national accreditation body outside the EU, in accordance with Regulation (EC) No 765/2008 (see summary), or by an accreditation body outside the EU that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum. FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) No 1151/2012 has applied since 3 January 2013, although Article 12(3) and Article 23(3) have applied since 4 January 2016, without prejudice to products already placed on the market before that date. Amending Regulation (EU) 2017/625 has applied since 14 December 2019. BACKGROUND For more information, see: Aims of EU quality schemes (European Commission). MAIN DOCUMENT Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, pp. 1\u201329). Successive amendments to Regulation (EU) No 1151/2012 have been incorporated into the original text. This consolidated version is of documentary value only. last update 14.10.2021"}
{"article": "30.6.2012 EN Official Journal of the European Union L 172/3 REGULATION (EU) No 530/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2012 on the accelerated phasing-in of double-hull or equivalent design requirements for single-hull oil tankers (recast) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Regulation (EC) No 417/2002 of the European Parliament and of the Council of 18 February 2002 on the accelerated phasing-in of double-hull or equivalent design requirements for single-hull oil tankers (3) has been substantially amended several times (4). Since further amendments are necessary, that Regulation should be recast in the interests of clarity. (2) Within the framework of the common transport policy, measures should be taken to enhance safety and prevent pollution in maritime transport. (3) The Union is seriously concerned by shipping accidents involving oil tankers and the associated pollution of its coast-lines and harm to its fauna and flora and other marine resources. (4) In its communication on a common policy on safe seas, the Commission underlined the request of the extraordinary Council on Environment and Transport of 25 January 1993 to support the action in the International Maritime Organisation (IMO) on the reduction of the safety gap between new and existing ships by upgrading and/or phasing out existing ships. (5) By its Resolution of 8 June 1993 on a common policy on safe seas (5), the Council fully supported the objectives of the Commission communication. (6) In its Resolution of 11 March 1994 on a common policy on safe seas (6), the European Parliament welcomed the Commission communication and called in particular for action to be taken to improve tanker safety standards. (7) In its Resolution of 20 January 2000 on the oil slick disaster caused by the wreck of the Erika (7), the European Parliament welcomed any efforts by the Commission to bring forward the date by which oil tankers will be obliged to have a double-hull construction. (8) In its Resolution of 21 November 2002 on the \u2018Prestige\u2019 oil tanker disaster off the coast of Galicia (8), the European Parliament called for stronger measures that can enter into force more rapidly, and stated that this new disaster has again underlined the need for effective action at international and Union level in order to significantly improve maritime safety. (9) The IMO has established, in the International Convention for the Prevention of Pollution from Ships, 1973 and the Protocol of 1978 related thereto (MARPOL 73/78), internationally agreed pollution prevention rules affecting the design and operation of oil tankers. Member States are Parties to MARPOL 73/78. (10) According to Article 3.3 of MARPOL 73/78, that Convention does not apply to warships, naval auxiliary or other ships owned or operated by a State and used only for government non-commercial services. (11) Comparison of tanker age and accident statistics shows increasing accident rates for older ships. It has been internationally agreed that the adoption of the 1992 amendments to MARPOL 73/78 requiring the application of the double-hull or equivalent design standards to existing single-hull oil tankers when they reach a certain age will provide those oil tankers with a higher degree of protection against accidental oil pollution in the event of collision or stranding. (12) It is in the Union\u2019s interest to adopt measures to ensure that oil tankers entering into ports and offshore terminals or anchoring in an area under the jurisdiction of Member States and oil tankers flying the flags of Member States comply with Regulation 20 of Annex I to MARPOL 73/78 as revised in 2004 by Resolution MEPC 117(52) adopted by the IMO\u2019s Marine Environment Protection Committee (MEPC) in order to reduce the risk of accidental oil pollution in European waters. (13) Resolution MEPC 114(50), adopted on 4 December 2003, introduced a new Regulation 21 into Annex I to MARPOL 73/78 on the prevention of oil pollution from oil tankers when carrying heavy grade oil (HGO) which bans the carriage of HGO in single-hull oil tankers. Paragraphs 5, 6 and 7 of Regulation 21 provide for the possibility of exemptions from the application of certain provisions of that Regulation. The statement by the Italian Presidency of the European Council on behalf of the European Union, recorded in the official report of the MEPC on its 50th session (MEPC 50/3), expresses a political commitment to refrain from making use of those exemptions. (14) Amendments to MARPOL 73/78 adopted by the IMO on 6 March 1992 entered into force on 6 July 1993. Those measures impose double-hull or equivalent design requirements for oil tankers delivered on or after 6 July 1996 aimed at preventing oil pollution in the event of collision or stranding. Within those amendments, a phasing-out scheme for single-hull oil tankers delivered before that date took effect from 6 July 1995 requiring oil tankers delivered before 1 June 1982 to comply with the double-hull or equivalent design standards not later than 25 years and, in some cases, 30 years after the date of their delivery. Such existing single-hull oil tankers would not be allowed to operate beyond 2005 and, in some cases, 2012 unless they comply with the double-hull or equivalent design requirements of Regulation 19 of Annex I to MARPOL 73/78. For existing single-hull oil tankers delivered after 1 June 1982 or those delivered before 1 June 1982 and which have been converted to comply with the requirements of MARPOL 73/78 on segregated ballast tanks and their protective location, this deadline will be reached at the latest in 2026. (15) Important amendments to Regulation 20 of Annex I to MARPOL 73/78 were adopted on 27 April 2001 by the 46th session of the MEPC by Resolution MEPC 95(46) and on 4 December 2003 by Resolution MEPC 111(50) in which a new accelerated phasing-out scheme for single-hull oil tankers was introduced. The respective final dates by which oil tankers must comply with Regulation 19 of Annex I to MARPOL 73/78 depend on the size and age of the ship. Oil tankers in that scheme are therefore divided into three categories according to their tonnage, construction and age. All these categories, including the lowest one, Category 3, are important for trade within the Union. (16) The final date by which a single-hull oil tanker is to be phased out is the anniversary of the date of delivery of the ship, according to a schedule starting in 2003 until 2005 for Category 1 oil tankers, and until 2010 for Category 2 and Category 3 oil tankers. (17) Regulation 20 of Annex I to MARPOL 73/78 introduces a requirement that all single-hull oil tankers may only continue to operate subject to compliance with a Condition Assessment Scheme (CAS), adopted on 27 April 2001 by Resolution MEPC 94(46) as amended by Resolution MEPC 99(48) of 11 October 2002 and by Resolution MEPC 112(50) of 4 December 2003. The CAS imposes an obligation that the flag State administration issues a Statement of Compliance and is involved in the CAS survey procedures. The CAS is designed to detect structural weaknesses in ageing oil tankers and should apply to all oil tankers above the age of 15 years. (18) Regulation 20.5 of Annex I to MARPOL 73/78 allows for an exception for Category 2 and Category 3 oil tankers to operate, under certain circumstances, beyond the time limit of their phasing-out. Regulation 20.8.2 of the same Annex gives the right for Parties to MARPOL 73/78 to deny entry into the ports or offshore terminals under their jurisdiction to oil tankers allowed to operate under this exception. Member States have declared their intention to use this right. Any decision to have recourse to this right should be communicated to the IMO. (19) It is important to ensure that the provisions of this Regulation do not lead to the safety of crew or oil tankers in search of a safe haven or a place of refuge being endangered. (20) In order to allow shipyards in Member States to repair single-hull oil tankers, Member States may make exceptions to allow entry into their ports of such vessels, provided they are not carrying any cargo. (21) It is very unlikely that the IMO would modify the content of the relevant Regulations in MARPOL 73/78 and Resolutions MEPC 111(50) and 94(46) adopted by the MEPC referred to in this Regulation. However, non-substantial amendments, such as renumbering, could be introduced in those texts. In order to keep this Regulation updated with the most recent developments of relevant international law, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission only in respect of such amendments in so far as they do not broaden the scope of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council, HAVE ADOPTED THIS REGULATION: Article 1 Purpose The purpose of this Regulation is to establish an accelerated phasing-in scheme for the application of the double-hull or equivalent design requirements of MARPOL 73/78, as defined in Article 3 of this Regulation, to single-hull oil tankers, and to ban the transport to or from ports of the Member States of heavy grade oil in single-hull oil tankers. Article 2 Scope 1. This Regulation shall apply to oil tankers of 5 000 tonnes deadweight and above: (a) which fly the flag of a Member State; (b) irrespective of their flag, which enter or leave a port or offshore terminal or anchor in an area under the jurisdiction of a Member State. For the purposes of Article 4(3), this Regulation shall apply to oil tankers of 600 tonnes deadweight and above. 2. This Regulation shall not apply to any warship, naval auxiliary or other ship, owned or operated by a State and used, for the time being, only on government non-commercial service. Member States shall, so far as is reasonable and practicable, endeavour to respect this Regulation for the ships referred to in this paragraph. Article 3 Definitions For the purpose of this Regulation, the following definitions shall apply: (1) \u2018MARPOL 73/78\u2019 means the International Convention for the Prevention of Pollution from Ships, 1973, as amended by the Protocol of 1978 relating thereto, in their up-to-date versions; (2) \u2018oil tanker\u2019 means an oil tanker as defined in Regulation 1.5 of Annex I to MARPOL 73/78; (3) \u2018deadweight\u2019 means deadweight as defined in Regulation 1.23 of Annex I to MARPOL 73/78; (4) \u2018Category 1 oil tanker\u2019 means an oil tanker of 20 000 tonnes deadweight or above and carrying crude oil, fuel oil, heavy diesel oil or lubricating oil as cargo or of 30 000 tonnes deadweight or above and carrying oil other than the above and which does not comply with the requirements in Regulations 18.1 to 18.9, 18.12 to 18.15, 30.4, 33.1, 33.2, 33.3, 35.1, 35.2 and 35.3 of Annex I to MARPOL 73/78; (5) \u2018Category 2 oil tanker\u2019 means an oil tanker of 20 000 tonnes deadweight or above and carrying crude oil, fuel oil, heavy diesel oil or lubricating oil as cargo or of 30 000 tonnes deadweight or above and carrying oil other than the above and which complies with the requirements in Regulations 18.1 to 18.9, 18.12 to 18.15, 30.4, 33.1, 33.2, 33.3, 35.1, 35.2 and 35.3 of Annex I to MARPOL 73/78 and is fitted with segregated ballast tanks protectively located (SBT/PL); (6) \u2018Category 3 oil tanker\u2019 means an oil tanker of 5 000 tonnes deadweight or above but less than that specified in points (4) and (5); (7) \u2018single-hull oil tanker\u2019 means an oil tanker which does not comply with the double-hull or equivalent design requirements in Regulations 19 and 28.6 of Annex I to MARPOL 73/78; (8) \u2018double-hull oil tanker\u2019 means an oil tanker: (a) of 5 000 tonnes deadweight or above, complying with the double-hull or equivalent design requirements in Regulations 19 and 28.6 of Annex I to MARPOL 73/78 or with the requirements in Regulation 20.1.3 thereof; or (b) of 600 tonnes deadweight or above but less than 5 000 tonnes deadweight, fitted with double-bottom tanks or spaces complying with Regulation 19.6.1 of Annex I to MARPOL 73/78 and wing tanks or spaces arranged in accordance with Regulation 19.3.1 thereof and complying with the requirement as to distance w in Regulation 19.6.2 thereof; (9) \u2018age\u2019 means the age of the ship, expressed in number of years from its date of delivery; (10) \u2018heavy diesel oil\u2019 means diesel oil as defined in Regulation 20 of Annex I to MARPOL 73/78; (11) \u2018fuel oil\u2019 means heavy distillates of crude oil or residues therefrom or blends of such materials as defined in Regulation 20 of Annex I to MARPOL 73/78; (12) \u2018heavy grade oil\u2019 means: (a) crude oils of a density at 15 \u00b0C of over 900 kg/m3 (corresponding to an API grade of less than 25,7); (b) oils other than crude oils and of a density at 15 \u00b0C of over 900 kg/m3 or a kinematic viscosity at 50 \u00b0C of over 180 mm2/s (corresponding to a kinematic viscosity of over 180 cSt); (c) bitumen and tar and emulsions thereof. Article 4 Compliance with the double-hull or equivalent design requirements by single-hull oil tankers 1. No oil tanker shall be allowed to operate under the flag of a Member State, nor shall any oil tanker, irrespective of its flag, be allowed to enter into ports or offshore terminals under the jurisdiction of a Member State unless such tanker is a double-hull oil tanker. 2. Notwithstanding paragraph 1, oil tankers of Category 2 or Category 3 which are equipped only with double bottoms or double sides not used for the transport of oil and extending for the whole length of the cargo tank, or with double-hulled spaces not used for the transport of oil and extending for the whole length of the cargo tank, but which do not meet the conditions for exemption from the provisions of Regulation 20.1.3 of Annex I to MARPOL 73/78, may continue to be operated, but not beyond the anniversary of the date of delivery of the ship in the year 2015 or the date on which the ship reaches the age of 25 years from its date of delivery, whichever is the sooner. 3. No oil tanker carrying heavy grade oil shall be allowed to fly the flag of a Member State unless such tanker is a double-hull oil tanker. No oil tanker carrying heavy grade oil, irrespective of its flag, shall be allowed to enter or leave ports or offshore terminals or to anchor in areas under the jurisdiction of a Member State, unless such tanker is a double-hull oil tanker. 4. Oil tankers operated exclusively in ports and inland navigation may be exempted from paragraph 3 provided that they are duly certified under inland waterway legislation. Article 5 Compliance with the Condition Assessment Scheme Irrespective of its flag, a single-hull oil tanker above 15 years of age shall not be allowed to enter or leave ports or offshore terminals or anchor in areas under the jurisdiction of a Member State unless such tanker complies with the Condition Assessment Scheme referred to in Article 6. Article 6 Condition Assessment Scheme For the purposes of Article 5, the Condition Assessment Scheme adopted by Resolution MEPC 94(46) of 27 April 2001 as amended by Resolution MEPC 99(48) of 11 October 2002 and by Resolution MEPC 112(50) of 4 December 2003, shall apply. Article 7 Final date After the anniversary of the date of delivery of the ship in 2015, the following shall no longer be allowed: (a) the continued operation, in accordance with Regulation 20.5 of Annex I to MARPOL 73/78, of Category 2 and Category 3 oil tankers under the flag of a Member State; (b) the entry into the ports or offshore terminals under the jurisdiction of a Member State of other Category 2 and Category 3 oil tankers, irrespective of the fact that they continue to operate under the flag of a third State in accordance with Regulation 20.5 of Annex I to MARPOL 73/78. Article 8 Exemptions for ships in difficulty or for ships to be repaired By way of derogation from Articles 4, 5 and 7, the competent authority of a Member State may, subject to national provisions, allow, under exceptional circumstances, an individual ship to enter or leave a port or offshore terminal or anchor in an area under the jurisdiction of that Member State, when: (a) an oil tanker is in difficulty and in search of a place of refuge; (b) an unloaded oil tanker is proceeding to a port of repair. Article 9 Notification to the IMO 1. Each Member State shall inform the IMO of its decision to deny entry to oil tankers, pursuant to Article 7 of this Regulation, operating in accordance with Regulation 20.5 of Annex I to MARPOL 73/78 into the ports or offshore terminals under its jurisdiction, on the basis of Regulation 20.8.2 of Annex I to MARPOL 73/78. 2. Each Member State shall notify the IMO if it allows, suspends, withdraws or declines the operation of a Category 1 or a Category 2 oil tanker entitled to fly its flag, in accordance with Article 5 of this Regulation, on the basis of Regulation 20.8.1 of Annex I to MARPOL 73/78. Article 10 Amendment procedure 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 11 concerning the alignment of the references in this Regulation to the non-substantial amendments, such as renumbering, adopted by the IMO to the Regulations of Annex I to MARPOL 73/78, as well as to Resolutions MEPC 111(50) and 94(46) as amended by Resolutions MEPC 99(48) and 112(50), in so far as such amendments do not broaden the scope of this Regulation. 2. The amendments to MARPOL 73/78 may be excluded from the scope of this Regulation, pursuant to Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) and amending the Regulations on maritime safety and the prevention of pollution from ships (9). Article 11 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this article. 2. The power to adopt the delegated acts referred to in Article 10(1) shall be conferred on the Commission for a period of five years from 20 July 2012. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 10(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 10(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 12 Repeal Regulation (EC) No 417/2002 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 13 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 13 June 2012. For the European Parliament The President M. SCHULZ For the Council The President N. WAMMEN (1) OJ C 43, 15.2.2012, p. 98. (2) Position of the European Parliament of 23 May 2012 (not yet published in the Official Journal) and decision of the Council of 7 June 2012. (3) OJ L 64, 7.3.2002, p. 1. (4) See Annex I. (5) OJ C 271, 7.10.1993, p. 1. (6) OJ C 91, 28.3.1994, p. 301. (7) OJ C 304, 24.10.2000, p. 198. (8) OJ C 25 E, 29.1.2004, p. 415. (9) OJ L 324, 29.11.2002, p. 1. ANNEX I Repealed Regulation with list of its successive amendments (referred to in Article 12) Regulation (EC) No 417/2002 of the European Parliament and of the Council (OJ L 64, 7.3.2002, p. 1) Regulation (EC) No 2099/2002 of the European Parliament and of the Council (OJ L 324, 29.11.2002, p. 1) Only Article 11 Regulation (EC) No 1726/2003 of the European Parliament and of the Council (OJ L 249, 1.10.2003, p. 1) Commission Regulation (EC) No 2172/2004 (OJ L 371, 18.12.2004, p. 26) Regulation (EC) No 457/2007 of the European Parliament and of the Council (OJ L 113, 30.4.2007, p. 1) Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ L 87, 31.3.2009, p. 109) Only point 7.4 of the Annex Commission Regulation (EC) No 1163/2009 (OJ L 314, 1.12.2009, p. 13) ANNEX II Correlation Table Regulation (EC) No 417/2002 This Regulation Article 1 Article 1 Article 2(1), introductory words Article 2(1), introductory words Article 2(1), first subparagraph, first indent Article 2(1), first subparagraph, point (b) Article 2(1), first subparagraph, second indent Article 2(1), first subparagraph, point (a) Article 2(1), second subparagraph Article 2(1), second subparagraph Article 2(2) Article 2(2) Article 3 Article 3 Article 4(1) introductory words Article 4(1) Article 4(1), point (a) \u2014 Article 4(1), point (b) \u2014 Article 4(2) Article 4(2) Article 4(3) Article 4(3) Article 4(4) Article 4(4) Article 4(5) \u2014 Article 4(6) \u2014 Article 5 Article 5 Article 6 Article 6 Article 7, introductory words Article 7, introductory words Article 7, first indent Article 7(a) Article 7, second indent Article 7(b) Article 7, final words Article 7, introductory words Article 8(1), introductory wording Article 8, introductory wording Article 8(1), first indent Article 8(a) Article 8(1), second indent Article 8(b) Article 8(2) \u2014 Article 9(1) \u2014 Article 9(2) Article 9(1) Article 9(3) Article 9(2) Article 10 \u2014 Article 11 Article 10 \u2014 Article 11 \u2014 \u2014 Article 12 Article 12, first paragraph \u2014 Article 12, second paragraph Article 13 Article 13 \u2014 Annex I \u2014 Annex II", "summary": "Maritime safety: accelerated phasing-in of double-hull oil tankers Maritime safety: accelerated phasing-in of double-hull oil tankers To reduce the risk of accidental oil pollution in European waters, this law forbids the transport of heavy grades of oil to or from European Union (EU) ports in single-hull oil tankers. It also ensures an accelerated phasing-in scheme for the application of the double-hull or equivalent design requirements single-hull oil tankers no later than 2015. ACT Regulation (EU) No 530/2012 of the European Parliament and of the Council of 13 June 2012 on the accelerated phasing-in of double-hull or equivalent design requirements for single-hull oil tankers. SUMMARY The latest EU law on the phasing-in of double-hull oil tankers, adopted in 2012, retains the essence of its previous law of 2002. It merges all the amendments made to the previous law into one text to make it clearer and thus more user-friendly. The law applies to oil tankers of 5 000 tonnes deadweight and above which fly the flag of an EU member country, or, irrespective of their flag, which enter or leave a port or offshore terminal or anchor in an area under the jurisdiction of an EU country. It does not, however, apply to any warship, naval auxiliary or other ship, owned or operated by a State and used, for the time being, only on government non-commercial service. The regulation: prohibits the transport to or from EU ports of heavy grades of oil in single-hull oil tankers; lays down an accelerated phasing-in scheme for the application of the double-hull or equivalent design requirements of the International Maritime Organization's International Convention for the Prevention of Pollution from Ships (also known as MARPOL) to single-hull oil tankers, with 2015 as the final deadline. Background In 2002, following a series of accidents involving oil tankers which resulted in serious pollution, the EU adopted a law requiring the phase-out of the more vulnerable single-hull oil tankers (where oil in the cargo tanks is separated from the seawater only by a bottom and a side plate) and their replacement by double-hull vessels (where the cargo tanks are surrounded by a second internal plate at a sufficient distance from the external plate). REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 530/2012 20.7.2012 - OJ L 172 of 30.6.2012 Last updated: 19.06.2014"}
{"article": "15.12.2010 EN Official Journal of the European Union L 331/48 REGULATION (EU) No 1094/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Central Bank (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The financial crisis in 2007 and 2008 exposed important shortcomings in financial supervision, both in particular cases and in relation to the financial system as a whole. Nationally based supervisory models have lagged behind financial globalisation and the integrated and interconnected reality of European financial markets, in which many financial institutions operate across borders. The crisis exposed shortcomings in the areas of cooperation, coordination, consistent application of Union law and trust between national supervisors. (2) Before and during the financial crisis, the European Parliament has called for a move towards more integrated European supervision in order to ensure a true level playing field for all actors at the level of the Union and to reflect the increasing integration of financial markets in the Union (in its resolutions of 13 April 2000 on the Commission communication on implementing the framework for financial markets: Action Plan (4), of 21 November 2002 on prudential supervision rules in the European Union (5), of 11 July 2007 on financial services policy (2005 to 2010) \u2013 White Paper (6), of 23 September 2008 with recommendations to the Commission on hedge funds and private equity (7) and of 9 October 2008 with recommendations to the Commission on Lamfalussy follow-up: future structure of supervision (8), and in its positions of 22 April 2009 on the amended proposal for a directive of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (9) and of 23 April 2009 on the proposal for a regulation of the European Parliament and of the Council on Credit Rating Agencies (10)). (3) In November 2008, the Commission mandated a High-Level Group chaired by Jacques de Larosi\u00e8re to make recommendations on how to strengthen European supervisory arrangements with a view to better protecting the citizen and rebuilding trust in the financial system. In its final report presented on 25 February 2009 (the \u2018de Larosi\u00e8re Report\u2019), the High-Level Group recommended that the supervisory framework be strengthened to reduce the risk and severity of future financial crises. It recommended reforms to the structure of supervision of the financial sector in the Union. The group also concluded that a European System of Financial Supervisors should be created, comprising three European Supervisory Authorities, one for the banking sector, one for the securities sector and one for the insurance and occupational pensions sector, and recommended the creation of a European Systemic Risk Council. The report represented the reforms the experts considered were needed and on which work had to begin immediately. (4) In its Communication of 4 March 2009 entitled \u2018Driving European Recovery\u2019, the Commission proposed to put forward draft legislation creating a European system of financial supervision and a European systemic risk board. In its Communication of 27 May 2009 entitled \u2018European Financial Supervision\u2019, it provided more detail about the possible architecture of such a new supervisory framework reflecting the main thrust of the de Larosi\u00e8re Report. (5) The European Council, in its conclusions of 19 June 2009, confirmed that a European System of Financial Supervisors, comprising three new European Supervisory Authorities, should be established. The system should be aimed at upgrading the quality and consistency of national supervision, strengthening oversight of cross-border groups and establishing a European single rule book applicable to all financial institutions in the internal market. It emphasised that the European Supervisory Authorities should also have supervisory powers in relation to credit rating agencies and invited the Commission to prepare concrete proposals on how the European System of Financial Supervisors could play a strong role in crisis situations, while stressing that decisions taken by the European Supervisory Authorities should not impinge on the fiscal responsibilities of Member States. (6) The financial and economic crisis has created real and serious risks to the stability of the financial system and the functioning of the internal market. Restoring and maintaining a stable and reliable financial system is an absolute prerequisite to preserving trust and coherence in the internal market, and thereby to preserve and improve the conditions for the establishment of a fully integrated and functioning internal market in the field of financial services. Moreover, deeper and more integrated financial markets offer better opportunities for financing and risk diversification, and thus help to improve the capacity of the economies to absorb shocks. (7) The Union has reached the limits of what can be done with the present status of the Committees of European Supervisors. The Union cannot remain in a situation where there is no mechanism to ensure that national supervisors arrive at the best possible supervisory decisions for cross-border financial institutions; where there is insufficient cooperation and information exchange between national supervisors; where joint action by national authorities requires complicated arrangements to take account of the patchwork of regulatory and supervisory requirements; where national solutions are most often the only feasible option in responding to problems at the level of the Union; and where different interpretations of the same legal text exist. The European System of Financial Supervision (hereinafter the ESFS\u2019) should be designed to overcome those deficiencies and provide a system that is in line with the objective of a stable and single Union financial market for financial services, linking national supervisors within a strong Union network. (8) The ESFS should be an integrated network of national and Union supervisory authorities, leaving day-to-day supervision to the national level. Greater harmonisation and the coherent application of rules for financial institutions and markets across the Union should also be achieved. In addition to the European Supervisory Authority (European Insurance and Occupational Pensions Authority) (hereinafter the Authority\u2019), a European Supervisory Authority (European Banking Authority) and a European Supervisory Authority (European Securities and Markets Authority) as well as a Joint Committee of the European Supervisory Authorities (hereinafter the Joint Committee\u2019) should be established. A European Systemic Risk Board (hereinafter the ESRB\u2019) should form part of the ESFS for the purposes of the tasks as specified in this Regulation and in Regulation (EU) No 1092/2010 of the European Parliament and of the Council (11). (9) The European Supervisory Authorities (hereinafter collectively referred to as the \u2018ESAs\u2019) should replace the Committee of European Banking Supervisors established by Commission Decision 2009/78/EC (12), the Committee of European Insurance and Occupational Pensions Supervisors established by Commission Decision 2009/79/EC (13) and the Committee of European Securities Regulators established by Commission Decision 2009/77/EC (14), and should assume all of the tasks and competences of those committees including the continuation of ongoing work and projects, where appropriate. The scope of each European Supervisory Authority\u2019s action should be clearly defined. The ESAs should be accountable to the European Parliament and the Council. When that accountability relates to cross-sectoral issues that have been coordinated through the Joint Committee, the ESAs should be accountable, through the Joint Committee, for such coordination. (10) The Authority should act with a view to improving the functioning of the internal market, in particular by ensuring a high, effective and consistent level of regulation and supervision taking account of the varying interests of all Member States and the different nature of financial institutions. The Authority should protect public values such as the stability of the financial system, the transparency of markets and financial products, and the protection of policyholders, pension scheme members and beneficiaries. The Authority should also prevent regulatory arbitrage, guarantee a level playing field, and strengthen international supervisory coordination, for the benefit of the economy at large, including financial institutions and other stakeholders, consumers and employees. Its tasks should also include promoting supervisory convergence and providing advice to the Union institutions in the area of insurance, reinsurance and occupational retirement provision regulation and supervision, and related corporate governance, auditing and financial reporting issues. The Authority should also be entrusted with certain responsibilities for existing and new financial activities. (11) The Authority should also be able to temporarily prohibit or restrict certain financial activities that threaten the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union in the cases specified and under the conditions laid down in the legislative acts referred to in this Regulation. If required to make such temporary prohibition in the case of an emergency situation, the Authority should do so in accordance with and under the conditions laid down in this Regulation. In cases where a temporary prohibition or restriction of certain financial activities has a cross-sectoral impact, sectoral legislation should provide that the Authority consult and coordinate its action with, where relevant, the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Securities and Markets Authority), through the Joint Committee. (12) The Authority should take due account of the impact of its activities on competition and innovation within the internal market, on the Union\u2019s global competitiveness, on financial inclusion, and on the Union\u2019s new strategy for jobs and growth. (13) In order to fulfil its objectives, the Authority should have legal personality as well as administrative and financial autonomy. (14) Based on the work of international bodies, systemic risk should be defined as a risk of disruption in the financial system with the potential to have serious negative consequences for the internal market and the real economy. All types of financial intermediaries, markets and infrastructures may be potentially systemically important to some degree. (15) Cross-border risk includes all risks caused by economic imbalances or financial failures in all or parts of the Union that have the potential to have significant negative consequences for the transactions between economic operators of two or more Member States, for the functioning of the internal market or for the public finances of the Union or any of its Member States. (16) The Court of Justice of the European Union in its judgment of 2 May 2006 in Case C-217/04 (United Kingdom of Great Britain and Northern Ireland v. European Parliament and Council of the European Union) held that \u2018nothing in the wording of Article 95 EC [now Article 114 of the Treaty on the Functioning of the European Union (TFEU)] implies that the addressees of the measures adopted by the Community legislature on the basis of that provision can only be the individual Member States. The legislature may deem it necessary to provide for the establishment of a Community body responsible for contributing to the implementation of a process of harmonisation in situations where, in order to facilitate the uniform implementation and application of acts based on that provision, the adoption of non-binding supporting and framework measures seems appropriate\u2019 (15). The purpose and tasks of the Authority \u2013 assisting competent national supervisory authorities in the consistent interpretation and application of Union rules and contributing to financial stability necessary for financial integration \u2013 are closely linked to the objectives of the Union acquis concerning the internal market for financial services. The Authority should therefore be established on the basis of Article 114 TFEU. (17) The following legislative acts lay down the tasks for the competent authorities of Member States, including cooperating with each other and with the Commission: Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (16), with the exception of Title IV thereof, Directive 2002/92/EC of the European Parliament and of the Council of 9 December 2002 on insurance mediation (17), Directive 2003/41/EC of the European Parliament and of the Council of 3 June 2003 on the activities and supervision of institutions for occupational retirement provision (18), Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate (19), Council Directive 64/225/EEC of 25 February 1964 on the abolition of restrictions on freedom of establishment and freedom to provide services in respect of reinsurance and retrocession (20), Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct insurance other than life assurance (21), Council Directive 73/240/EEC of 24 July 1973 abolishing restrictions on freedom of establishment in the business of direct insurance other than life assurance (22), Council Directive 76/580/EEC of 29 June 1976 amending Directive 73/239/EEC on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct insurance other than life assurance (23), Council Directive 78/473/EEC of 30 May 1978 on the coordination of laws, regulations and administrative provisions relating to Community co-insurance (24), Council Directive 84/641/EEC of 10 December 1984 amending, particularly as regards tourist assistance, the First Council Directive 73/239/EEC on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (25), Council Directive 87/344/EEC of 22 June 1987 on the coordination of laws, regulations and administrative provisions relating to legal expenses insurance (26), Council Directive 88/357/EEC of 22 June 1988 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance and laying down provisions to facilitate the effective exercise of freedom to provide services (27), Council Directive 92/49/EEC of 18 June 1992 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance (third non-life insurance Directive) (28), Directive 98/78/EC of the European Parliament and of the Council of 27 October 1998 on the supplementary supervision of insurance undertakings in an insurance group (29), Directive 2001/17/EC of the European Parliament and of the Council of 19 March 2001 on the reorganisation and winding-up of insurance undertakings (30), Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance (31)and Directive 2005/68/EC of the European Parliament and of the Council of 16 November 2005 on reinsurance (32). However, with regard to institutions for occupational retirement provision, the Authority\u2019s actions should be without prejudice to national social and labour law. (18) Existing Union legislation regulating the field covered by this Regulation also includes the relevant parts of Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (33), and of Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services (34). (19) It is desirable that the Authority contribute to the assessment of the need for a European network of national insurance guarantee schemes which is adequately funded and sufficiently harmonised. (20) In accordance with the Declaration (No 39) on Article 290 of the Treaty on the Functioning of the European Union (TFEU), annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, the elaboration of regulatory technical standards requires assistance of technical expertise in a form which is specific to the financial services area. It is necessary to allow the Authority to provide such expertise also on standards or parts of standards that are not based on a draft technical standard that it has elaborated. (21) There is a need to introduce an effective instrument to establish harmonised regulatory technical standards in financial services to ensure, also through a single rulebook, a level playing field and adequate protection of policyholders, pension scheme members and other beneficiaries across the Union. As a body with highly specialised expertise, it is efficient and appropriate to entrust the Authority, in areas defined by Union law, with the elaboration of draft regulatory technical standards, which do not involve policy choices. (22) The Commission should endorse those draft regulatory technical standards by means of delegated acts under Article 290 TFEU in order to give them binding legal effect. They should be subject to amendment only in very restricted and extraordinary circumstances, since the Authority is the actor in close contact with and knowing best the daily functioning of financial markets. Draft regulatory technical standards would be subject to amendment if they were incompatible with Union law, did not respect the principle of proportionality or ran counter to the fundamental principles of the internal market for financial services as reflected in the acquis of Union financial services legislation. The Commission should not change the content of the draft regulatory technical standards prepared by the Authority without prior coordination with the Authority. To ensure a smooth and expeditious adoption process for those standards, the Commission\u2019s decision to endorse draft regulatory technical standards should be subject to a time limit. (23) Given the technical expertise of the Authority in the areas where regulatory technical standards should be developed, note should be taken of the Commission\u2019s stated intention to rely, as a rule, on the draft regulatory technical standards submitted to it by the Authority in view of the adoption of the corresponding delegated acts. However, in cases where the Authority fails to submit a draft regulatory technical standard within the time limits set out by the relevant legislative act, it should be ensured that the result of the exercise of delegated power is actually achieved, and the efficiency of the decision-making process be maintained. In those cases, the Commission should therefore be empowered to adopt regulatory technical standards in the absence of a draft by the Authority. (24) The Commission should also be empowered to adopt implementing technical standards by means of implementing acts under Article 291 TFEU. (25) In areas not covered by regulatory or implementing technical standards, the Authority should have the power to issue guidelines and recommendations on the application of Union law. In order to ensure transparency and to strengthen compliance by national supervisory authorities with those guidelines and recommendations, it should be possible for the Authority to publish the reasons for supervisory authorities\u2019 non-compliance with those guidelines and recommendations. (26) Ensuring the correct and full application of Union law is a core prerequisite for the integrity, transparency, efficiency and orderly functioning of financial markets, the stability of the financial system, and for neutral conditions of competition for financial institutions in the Union. A mechanism should therefore be established whereby the Authority addresses instances of non-application or incorrect application of Union law amounting to a breach thereof. That mechanism should apply in areas where Union law defines clear and unconditional obligations. (27) To allow for a proportionate response to instances of incorrect or insufficient application of Union law, a three-step mechanism should apply. First, the Authority should be empowered to investigate alleged incorrect or insufficient application of Union law obligations by national authorities in their supervisory practice, concluded by a recommendation. Second, where the competent national authority does not follow the recommendation, the Commission should be empowered to issue a formal opinion taking into account the Authority\u2019s recommendation, requiring the competent authority to take the actions necessary to ensure compliance with Union law. (28) Third, to overcome exceptional situations of persistent inaction by the competent authority concerned, the Authority should be empowered, as a last resort, to adopt decisions addressed to individual financial institutions. That power should be limited to exceptional circumstances in which a competent authority does not comply with the formal opinion addressed to it and in which Union law is directly applicable to financial institutions by virtue of existing or future Union regulations. (29) Serious threats to the orderly functioning and integrity of financial markets or the stability of the financial system in the Union require a swift and concerted response at Union level. The Authority should therefore be able to require national supervisory authorities to take specific actions to remedy an emergency situation. The power to determine the existence of an emergency situation should be conferred on the Council, following a request by any of the ESAs, the Commission or the ESRB. (30) The Authority should be able to require national supervisory authorities to take specific action to remedy an emergency situation. The action undertaken by the Authority in this respect should be without prejudice to the Commission\u2019s powers under Article 258 TFEU to initiate infringement proceedings against the Member State of that supervisory authority for its failure to take such action, and without prejudice to the Commission\u2019s right in such circumstances to seek interim measures in accordance with the rules of procedure of the Court of Justice of the European Union. Furthermore, it should be without prejudice to any liability that that Member State might incur in accordance with the case law of the Court of Justice of the European Union if its supervisory authorities fail to take the action required by the Authority. (31) In order to ensure efficient and effective supervision and a balanced consideration of the positions of the competent authorities in different Member States, the Authority should be able to settle disagreements in cross-border situations between those competent authorities with binding effect, including within colleges of supervisors. A conciliation phase should be provided for during which the competent authorities may reach an agreement. The Authority\u2019s competence should cover disagreements on the procedure or content of an action or inaction by a competent authority of a Member State in cases specified in the legally binding Union acts referred to in this Regulation. In such a situation, one of the supervisors involved should be entitled to refer the issue to the Authority, which should act in accordance with this Regulation. The Authority should be empowered to require the competent authorities concerned to take specific action or to refrain from action in order to settle the matter in order to ensure compliance with Union law, with binding effects for the competent authorities concerned. If a competent authority does not comply with the settlement decision addressed to it, the Authority should be empowered to adopt decisions directly addressed to financial institutions in areas of Union law directly applicable to them. The power to adopt such decisions should apply only as a last resort and then only to ensure the correct and consistent application of Union law. In cases where the relevant Union legislation confers discretion on Member States\u2019 competent authorities, decisions taken by the Authority cannot replace the exercise in compliance with Union law of that discretion. (32) The crisis has proven that the current system of cooperation between national authorities whose powers are limited to individual Member States is insufficient as regards financial institutions that operate across borders. (33) Expert Groups set up by Member States to examine the causes of the crisis and make suggestions to improve the regulation and supervision of the financial sector have confirmed that the current arrangements are not a sound basis for the future regulation and supervision of cross-border financial institutions across the Union. (34) As the de Larosi\u00e8re Report indicates, \u2018[i]n essence, we have two alternatives: the first \u201cchacun pour soi\u201d beggar-thy-neighbour solutions; or the second \u2013 enhanced, pragmatic, sensible European cooperation for the benefit of all to preserve an open world economy. This will bring undoubted economic gains\u2019. (35) Colleges of supervisors play an important role in the efficient, effective and consistent supervision of financial institutions operating across borders. The Authority should contribute to promoting and monitoring the efficient, effective and consistent functioning of the colleges of supervisors and, in that respect, have a leading role in ensuring the consistent and coherent functioning of colleges of supervisors for cross-border financial institutions across the Union. The Authority should therefore have full participation rights in colleges of supervisors with a view to streamlining the functioning of and the information exchange process in the colleges of supervisors and to foster convergence and consistency across colleges in the application of Union law. As the de Larosi\u00e8re Report states, \u2018competition distortions and regulatory arbitrage stemming from different supervisory practices must be avoided, because they have the potential of undermining financial stability \u2013 inter alia by encouraging a shift of financial activity to countries with lax supervision. The supervisory system has to be perceived as fair and balanced\u2019. (36) Convergence in the fields of crisis prevention, management and resolution, including funding mechanisms, is necessary in order to ensure that public authorities are able to resolve failing financial institutions whilst minimising the impact of failures on the financial system, reliance on taxpayer funds to bail out insurance or reinsurance undertakings and the use of public sector resources, limiting damage to the economy, and coordinating the application of national resolution measures. In this regard, the Commission should be able to request the Authority to contribute to the assessment referred to in Article 242 of Directive 2009/138/EC, in particular as regards the cooperation of supervisory authorities within, and functionality of, the colleges of supervisors; the supervisory practices concerning setting the capital add-ons; the assessment of the benefit of enhancing group supervision and capital management within a group of insurance or reinsurance undertakings, including possible measures to enhance the sound cross-border management of insurance groups, notably in respect of risks and assets; and reporting on any new developments and progress concerning a set of coordinated national crisis management arrangements, including the necessity or otherwise of a system of coherent and credible funding mechanisms, with appropriate financing instruments. (37) In the current review of Directive 94/19/EC of the European Parliament and the Council of 30 May 1994 on deposit-guarantee schemes (35) and Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes (36), the Commission\u2019s intention to pay special attention to the need to ensure further harmonisation throughout the Union is noted. In the insurance sector, the Commission\u2019s intention to examine the possibility of introducing Union rules protecting insurance policy holders in case of a failing insurance company is also noted. The ESAs should play an important role in those areas and appropriate powers concerning the European network of national insurance guarantee schemes should be conferred upon them. (38) The delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks, to foster cooperation and thereby streamline the supervisory process, as well as to reduce the burden imposed on financial institutions. This Regulation should therefore provide a clear legal basis for such delegation. Whilst respecting the general rule that delegation should be allowed, Member States should be able to introduce specific conditions for the delegation of responsibilities, for example, regarding information about, and the notification of, delegation arrangements. Delegation of tasks means that tasks are carried out by the Authority or by a national supervisory authority other than the responsible authority, while the responsibility for supervisory decisions remains with the delegating authority. By the delegation of responsibilities, the Authority or a national supervisory authority (the delegate) should be able to decide upon a certain supervisory matter in its own name in lieu of the delegating authority. Delegations should be governed by the principle of allocating supervisory competence to a supervisor which is best placed to take action in the subject matter. A reallocation of responsibilities would be appropriate, for example, for reasons of economies of scale or scope, of coherence in group supervision, and of optimal use of technical expertise among national supervisory authorities. Decisions by the delegate should be recognised by the delegating authority and by other competent authorities as determinative if those decisions are within the scope of the delegation. Relevant Union legislation could further specify the principles for the reallocation of responsibilities upon agreement. The Authority should facilitate and monitor delegation agreements between national supervisory authorities by all appropriate means. It should be informed in advance of intended delegation agreements, in order to be able to express an opinion where appropriate. It should centralise the publication of such agreements to ensure timely, transparent and easily accessible information about agreements for all parties concerned. It should identify and disseminate best practices regarding delegation and delegation agreements. (39) The Authority should actively foster supervisory convergence across the Union with the aim of establishing a common supervisory culture. (40) Peer reviews are an efficient and effective tool for fostering consistency within the network of financial supervisors. The Authority should therefore develop the methodological framework for such reviews and conduct them on a regular basis. Reviews should focus not only on the convergence of supervisory practices, but also on the capacity of supervisors to achieve high-quality supervisory outcomes, as well as on the independence of those competent authorities. The outcome of peer reviews should be made public with the agreement of the competent authority subject to the review. Best practices should also be identified and made public. (41) The Authority should actively promote a coordinated Union supervisory response, in particular to ensure the orderly functioning and integrity of financial markets and the stability of the financial system in the Union. In addition to its powers for action in emergency situations, the Authority should therefore be entrusted with a general coordination function within the ESFS. The smooth flow of all relevant information between competent authorities should be a particular focus of the Authority\u2019s actions. (42) In order to safeguard financial stability it is necessary to identify, at an early stage, trends, potential risks and vulnerabilities stemming from the micro-prudential level, across borders and across sectors. The Authority should monitor and assess such developments in the area of its competence and, where necessary, inform the European Parliament, the Council, the Commission, the other European Supervisory Authorities and the ESRB on a regular and, as necessary, on an ad hoc basis. The Authority should also, in cooperation with the ESRB, initiate and coordinate Union-wide stress tests to assess the resilience of financial institutions to adverse market developments, and it should ensure that an as consistent as possible methodology is applied at the national level to such tests. In order to perform its functions properly, the Authority should conduct economic analyses of the markets and the impact of potential market developments. (43) Given the globalisation of financial services and the increased importance of international standards, the Authority should foster dialogue and cooperation with supervisors outside the Union. It should be empowered to develop contacts and enter into administrative arrangements with the supervisory authorities and administrations of third countries and with international organisations, while fully respecting the existing roles and respective competences of the Member States and the Union institutions. Participation in the work of the Authority should be open to countries which have concluded agreements with the Union whereby they have adopted and are applying Union law, and the Authority should be able to cooperate with third countries which apply legislation that has been recognised as equivalent to that of the Union. (44) The Authority should serve as an independent advisory body to the European Parliament, the Council, and the Commission in the area of its competence. Without prejudice to the competencies of the competent authorities concerned, the Authority should be able to provide its opinion on the prudential assessment of mergers and acquisitions under Directive 92/49/EEC and Directives 2002/83/EC and 2005/68/EC, as amended by Directive 2007/44/EC (37) in those cases in which that Directive requires consultation between competent authorities from two or more Member States. (45) In order to carry out its duties effectively, the Authority should have the right to request all necessary information. To avoid the duplication of reporting obligations for financial institutions, that information should normally be provided by the national supervisory authorities which are closest to the financial markets and institutions and should take into account already existing statistics. However, as a last resort, the Authority should be able to address a duly justified and reasoned request for information directly to a financial institution where a national competent authority does not or cannot provide such information in a timely fashion. Member States\u2019 authorities should be obliged to assist the Authority in enforcing such direct requests. In that context, the work on common reporting formats is essential. The measures for the collection of information should be without prejudice to the legal framework of the European Statistical System and the European System of Central Banks in the field of statistics. This Regulation should therefore be without prejudice both to Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics (38) and to Council Regulation (EC) No 2533/98 of 23 November 1998 concerning the collection of statistical information by the European Central Bank (39). (46) Close cooperation between the Authority and the ESRB is essential to give full effectiveness to the functioning of the ESRB and the follow-up to its warnings and recommendations. The Authority and the ESRB should share any relevant information with each other. Data related to individual undertakings should be provided only upon reasoned request. Upon receipt of warnings or recommendations addressed by the ESRB to the Authority or a national supervisory authority, the Authority should ensure follow-up as appropriate. (47) The Authority should consult interested parties on regulatory or implementing technical standards, guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures. Before adopting draft regulatory or implementing technical standards, guidelines and recommendations, the Authority should carry out an impact study. For reasons of efficiency, an Insurance and Reinsurance Stakeholder Group and an Occupational Pensions Stakeholder Group should be used for that purpose and should represent, in balanced proportions and respectively, the relevant financial institutions operating in the Union, representing the diverse business models and sizes of financial institutions and businesses; small and medium-sized enterprises (SMEs); trade unions; academics; consumers; other retail users of those financial institutions; and representatives of relevant professional associations. Those stakeholder groups should work as an interface with other user groups in the financial services area established by the Commission or by Union legislation. (48) Members of the stakeholder groups representing non-profit organisations or academics should receive adequate compensation in order to allow persons that are neither well-funded nor industry representatives to take part fully in the debate on financial regulation. (49) The stakeholder groups should be consulted by the Authority and should be able to submit opinions and advice to the Authority on issues related to the optional application to institutions covered by Directive 2002/83/EC or Directive 2003/41/EC. (50) Member States have a core responsibility for ensuring coordinated crisis management and preserving financial stability in crisis situations, in particular with regard to stabilising and resolving individual failing financial institutions. Decisions by the Authority in emergency or settlement situations affecting the stability of a financial institution should not impinge on the fiscal responsibilities of Member States. A mechanism should be established whereby Member States may invoke this safeguard and ultimately bring the matter before the Council for a decision. However, that safeguard mechanism should not be abused, in particular in relation to a decision taken by the Authority which does not have a significant or material fiscal impact, such as a reduction of income linked to the temporary prohibition of specific activities or products for consumer protection purposes. When taking decisions under the safeguard mechanism, the Council should vote in accordance with the principle where each member has one vote. It is appropriate to confer on the Council a role in this matter given the particular responsibilities of the Member States in this respect. Given the sensitivity of the issue, strict confidentiality arrangements should be ensured. (51) In its decision-making procedures, the Authority should be bound by Union rules and general principles on due process and transparency. The right of the addressees of the Authority\u2019s decisions to be heard should be fully respected. The Authority\u2019s acts should form an integral part of Union law. (52) A Board of Supervisors composed of the heads of the relevant competent authorities in each Member State, and chaired by the Chairperson of the Authority, should be the principal decision-making organ of the Authority. Representatives of the Commission, the ESRB, the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Securities and Markets Authority) should participate as observers. Members of the Board of Supervisors should act independently and only in the Union\u2019s interest. (53) As a general rule, the Board of Supervisors should take its decisions by simple majority in accordance with the principle where each member has one vote. However, for acts of a general nature, including those relating to regulatory and implementing technical standards, guidelines and recommendations, for budgetary matters as well as in respect of requests by a Member State to reconsider a decision by the Authority to temporarily prohibit or restrict certain financial activities, it is appropriate to apply the rules of qualified majority voting as laid down in Article 16(4) of the Treaty on European Union and in the Protocol (No 36) on transitional provisions annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union. Cases concerning the settlement of disagreements between national supervisory authorities should be examined by a restricted, objective panel, composed of members who neither are representatives of the competent authorities which are party to the disagreement nor have any interest in the conflict or direct links to the competent authorities concerned. The composition of the panel should be appropriately balanced. The decision taken by the panel should be approved by the Board of Supervisors by simple majority in accordance with the principle where each member has one vote. However, with regard to decisions taken by the consolidating supervisor, the decision proposed by the panel could be rejected by members representing a blocking minority of the votes as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions. (54) A Management Board, composed of the Chairperson of the Authority, of representatives of national supervisory authorities and of the Commission, should ensure that the Authority carries out its mission and performs the tasks assigned to it. The Management Board should be entrusted with the necessary powers, inter alia, to propose the annual and multi-annual work programme, to exercise certain budgetary powers, to adopt the Authority\u2019s staff policy plan, to adopt special provisions on the right to access to documents and to propose the annual report. (55) The Authority should be represented by a full-time Chairperson, appointed by the Board of Supervisors, on the basis of merit, skills, knowledge of financial institutions and markets, and of experience relevant to financial supervision and regulation, following an open selection procedure organised and managed by the Board of Supervisors assisted by the Commission. For the designation of the first Chairperson of the Authority, the Commission should, inter alia, draw up a shortlist of candidates on the basis of merit, skills, knowledge of financial institutions and markets, and experience relevant to financial supervision and regulation. For the subsequent designations, the opportunity of having a shortlist drawn up by the Commission should be reviewed in a report to be established pursuant to this Regulation. Before the selected person takes up his duties, and up to 1 month after his selection by the Board of Supervisors, the European Parliament should be entitled, after having heard the person selected, to object to his designation. (56) The management of the Authority should be entrusted to an Executive Director, who should have the right to participate in meetings of the Board of Supervisors and the Management Board without the right to vote. (57) In order to ensure cross-sectoral consistency in the activities of the ESAs, they should coordinate closely through a Joint Committee and reach common positions where appropriate. The Joint Committee should coordinate the functions of the ESAs in relation to financial conglomerates and other cross-sectoral matters. Where relevant, acts also falling within the area of competence of the European Supervisory Authority (European Banking Authority) or the European Supervisory Authority (European Securities and Markets Authority) should be adopted in parallel by the European Supervisory Authorities concerned. The Joint Committee should be chaired for a 12-month term on a rotating basis by the Chairpersons of the ESAs. The Chairperson of the Joint Committee should be a Vice-Chair of the ESRB. The Joint Committee should have dedicated staff provided by the ESAs to allow for informal information sharing and the development of a common supervisory culture approach across the ESAs. (58) It is necessary to ensure that the parties affected by decisions adopted by the Authority may have recourse to the necessary remedies. To protect effectively the rights of parties, and for reasons of procedural economy, where the Authority has decision-making powers, parties should be granted a right of appeal to a Board of Appeal. For reasons of efficiency and consistency, the Board of Appeal should be a joint body of the ESAs, independent from their administrative and regulatory structures. The decisions of the Board of Appeal should be subject to appeal before the Court of Justice of the European Union. (59) In order to guarantee its full autonomy and independence, the Authority should be granted an autonomous budget with revenues mainly from obligatory contributions from national supervisory authorities and from the General Budget of the European Union. Union financing of the Authority is subject to an agreement by the budgetary authority in accordance with Point 47 of the Interinstitutional Agreement between the European Parliament, the Council and the Commission of 17 May 2006 on budgetary discipline and sound financial management (40). The Union budgetary procedure should be applicable. The auditing of accounts should be undertaken by the Court of Auditors. The overall budget is subject to the discharge procedure. (60) Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (41) should apply to the Authority. The Authority should also accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (42). (61) In order to ensure open and transparent employment conditions and equal treatment of staff, the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities (43) should apply to the staff of the Authority. (62) It is essential that business secrets and other confidential information be protected. The confidentiality of information made available to the Authority and exchanged in the network should be subject to stringent and effective confidentiality rules. (63) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (44) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (45) are fully applicable to the processing of personal data for the purposes of this Regulation. (64) In order to ensure the transparent operation of the Authority, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (46) should apply to the Authority. (65) Third countries should be allowed to participate in the work of the Authority in accordance with appropriate agreements to be concluded by the Union. (66) Since the objectives of this Regulation, namely improving the functioning of the internal market by means of ensuring a high, effective and consistent level of prudential regulation and supervision, protecting policyholders, pension scheme members and other beneficiaries, protecting the integrity, efficiency and orderly functioning of financial markets, maintaining the stability of the financial system, and strengthening international supervisory coordination, cannot be sufficiently achieved by the Member States and can, therefore, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (67) The Authority should assume all current tasks and powers of the Committee of European Insurance and Occupational Pensions Supervisors. Commission Decision 2009/79/EC should therefore be repealed on the date of the establishment of the Authority, and Decision No 716/2009/EC of the European Parliament and of the Council of 16 September 2009 establishing a Community programme to support specific activities in the field of financial services, financial reporting and auditing (47) should be amended accordingly. Given the existing structures and operations of the Committee of European Insurance and Occupational Pensions Supervisors, it is important to ensure very close cooperation between the Committee of European Insurance and Occupational Pensions Supervisors and the Commission when establishing appropriate transitional arrangements, to ensure that the period during which the Commission is responsible for the administrative establishment and initial administrative operation of the Authority be as limited as possible. (68) It is appropriate to set a time limit for the application of this Regulation in order to ensure that the Authority is adequately prepared to begin operations and a smooth transition from the Committee of European Insurance and Occupational Pensions Supervisors. The Authority should be appropriately financed. At least initially, it should be financed 40 % from Union funds and 60 % through contributions from Member States, made in accordance with the weighting of votes set out in Article 3(3) of the Protocol (No 36) on transitional provisions. (69) In order to enable the Authority to be established on 1 January 2011, this Regulation should enter into force on the day following its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: CHAPTER I ESTABLISHMENT AND LEGAL STATUS Article 1 Establishment and scope of action 1. This Regulation establishes a European Supervisory Authority (European Insurance and Occupational Pensions Authority) (hereinafter the Authority\u2019). 2. The Authority shall act within the powers conferred by this Regulation and within the scope of Directive2009/138/EC with the exception of Title IV thereof, of Directives 2002/92/EC, 2003/41/EC, 2002/87/EC, 64/225/EEC, 73/239/EEC, 73/240/EEC, 76/580/EEC, 78/473/EEC, 84/641/EEC, 87/344/EEC, 88/357/EEC, 92/49/EEC, 98/78/EC, 2001/17/EC, 2002/83/EC, 2005/68/EC and, to the extent that those acts apply to insurance undertakings, reinsurance undertakings, institutions for occupational retirement provision and insurance intermediaries, within the relevant parts of Directives 2005/60/EC and 2002/65/EC, including all directives, regulations, and decisions based on those acts, and of any further legally binding Union act which confers tasks on the Authority. 3. The Authority shall also act in the field of activities of insurance undertakings, reinsurance undertakings, financial conglomerates, institutions for occupational retirement provision and insurance intermediaries, in relation to issues not directly covered in the acts referred to in paragraph 2, including matters of corporate governance, auditing and financial reporting, provided that such actions by the Authority are necessary to ensure the effective and consistent application of those acts. 4. With regard to institutions for occupational retirement provision, the Authority shall act without prejudice to national social and labour law. 5. The provisions of this Regulation are without prejudice to the powers of the Commission, in particular under Article 258 TFEU, to ensure compliance with Union law. 6. The objective of the Authority shall be to protect the public interest by contributing to the short, medium and long-term stability and effectiveness of the financial system, for the Union economy, its citizens and businesses. The Authority shall contribute to: (a) improving the functioning of the internal market, including in particular a sound, effective and consistent level of regulation and supervision, (b) ensuring the integrity, transparency, efficiency and orderly functioning of financial markets, (c) strengthening international supervisory coordination, (d) preventing regulatory arbitrage and promoting equal conditions of competition, (e) ensuring the taking of risks related to insurance, reinsurance and occupational pensions activities is appropriately regulated and supervised, and (f) enhancing customer protection. For those purposes, the Authority shall contribute to ensuring the consistent, efficient and effective application of the acts referred to in paragraph 2, foster supervisory convergence, provide opinions to the European Parliament, the Council, and the Commission and undertake economic analyses of the markets to promote the achievement of the Authority\u2019s objective. In the exercise of the tasks conferred upon it by this Regulation, the Authority shall pay particular attention to any potential systemic risk posed by financial institutions, the failure of which may impair the operation of the financial system or the real economy. When carrying out its tasks, the Authority shall act independently and objectively and in the interest of the Union alone. Article 2 European System of Financial Supervision 1. The Authority shall form part of a European System of Financial Supervision (ESFS). The main objective of the ESFS shall be to ensure that the rules applicable to the financial sector are adequately implemented to preserve financial stability and to ensure confidence in the financial system as a whole and sufficient protection for the customers of financial services. 2. The ESFS shall comprise the following: (a) the European Systemic Risk Board (ESRB), for the purposes of the tasks as specified in Regulation (EU) No 1092/2010 and this Regulation; (b) the Authority; (c) the European Supervisory Authority (European Banking Authority) established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council (48); (d) the European Supervisory Authority (European Securities and Markets Authority) established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (49); (e) the Joint Committee of the European Supervisory Authorities (Joint Committee) for the purposes of carrying out the tasks as specified in Articles 54 to 57 of this Regulation, of Regulation (EU) No 1093/2010 and of Regulation (EU) No 1095/2010; (f) the competent or supervisory authorities in the Member States as specified in the Union acts referred to in Article 1(2) of this Regulation, of Regulation (EU) No 1093/2010 and of Regulation (EU) No 1095/2010; 3. The Authority shall cooperate regularly and closely with the ESRB as well as with the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Securities and Markets Authority) through the Joint Committee, ensuring cross-sectoral consistency of work and reaching joint positions in the area of supervision of financial conglomerates and on other cross-sectoral issues. 4. In accordance with the principle of sincere cooperation under Article 4(3) of the Treaty on European Union, the parties to the ESFS shall cooperate with trust and full mutual respect, in particular in ensuring the flow of appropriate and reliable information between them. 5. Those supervisory authorities that are party to the ESFS shall be obliged to supervise financial institutions operating in the Union in accordance with the acts referred to in Article 1(2). Article 3 Accountability of the Authorities The Authorities referred to in Article 2(2)(a) to (d) shall be accountable to the European Parliament and the Council. Article 4 Definitions For the purposes of this Regulation the following definitions apply: (1) \u2018financial institutions\u2019 means undertakings, entities and natural and legal persons subject to any of the legislative acts referred to in Article 1(2). With regard to Directive 2005/60/EC, \u2018financial institutions\u2019 means only insurance undertakings and insurance intermediaries as defined in that Directive; (2) \u2018competent authorities\u2019 means: (i) supervisory authorities as defined in Directive 2009/138/EC, and competent authorities as defined in Directive 2003/41/EC and 2002/92/EC; (ii) with regard to Directives 2002/65/EC and 2005/60/EC, the authorities competent for ensuring compliance with the requirements of those Directives by financial institutions as defined in point (1). Article 5 Legal status 1. The Authority shall be a Union body with legal personality. 2. In each Member State, the Authority shall enjoy the most extensive legal capacity accorded to legal persons under national law. It may, in particular, acquire or dispose of movable and immovable property and be a party to legal proceedings. 3. The Authority shall be represented by its Chairperson. Article 6 Composition The Authority shall comprise: (1) a Board of Supervisors, which shall exercise the tasks set out in Article 43; (2) a Management Board, which shall exercise the tasks set out in Article 47; (3) a Chairperson, who shall exercise the tasks set out in Article 48; (4) an Executive Director, who shall exercise the tasks set out in Article 53; (5) a Board of Appeal, which shall exercise the tasks set out in Article 60. Article 7 Seat The Authority shall have its seat in Frankfurt am Main. CHAPTER II TASKS AND POWERS OF THE AUTHORITY Article 8 Tasks and powers of the Authority 1. The Authority shall have the following tasks: (a) to contribute to the establishment of high-quality common regulatory and supervisory standards and practices, in particular by providing opinions to the Union institutions and by developing guidelines, recommendations, and draft regulatory and implementing technical standards which shall be based on the legislative acts referred to in Article 1(2); (b) to contribute to the consistent application of legally binding Union acts, in particular by contributing to a common supervisory culture, ensuring consistent, efficient and effective application of the acts referred to in Article 1(2), preventing regulatory arbitrage, mediating and settling disagreements between competent authorities, ensuring effective and consistent supervision of financial institutions, ensuring a coherent functioning of colleges of supervisors and taking actions, inter alia, in emergency situations; (c) to stimulate and facilitate the delegation of tasks and responsibilities among competent authorities; (d) to cooperate closely with the ESRB, in particular by providing the ESRB with the necessary information for the achievement of its tasks and by ensuring a proper follow up to the warnings and recommendations of the ESRB; (e) to organise and conduct peer review analyses of competent authorities, including issuing guidelines and recommendations and identifying best practices, in order to strengthen consistency in supervisory outcomes; (f) to monitor and assess market developments in the area of its competences; (g) to undertake economic analyses of markets to inform the discharge of the Authority\u2019s functions; (h) to foster the protection of policyholders, pension scheme members and beneficiaries (i) to contribute to the consistent and coherent functioning of colleges of supervisors, the monitoring, assessment and measurement of systemic risk, the development and coordination of recovery and resolution plans, providing a high level of protection to policy holders, to beneficiaries and throughout the Union, in accordance with Articles 21 to 26; (j) to fulfil any other specific tasks set out in this Regulation or in other legislative acts; (k) to publish on its website, and to update regularly, information relating to its field of activities, in particular, within the area of its competence, on registered financial institutions, in order to ensure information is easily accessible by the public; (l) to take over, as appropriate, all existing and ongoing tasks from the Committee of European Insurance and Occupational Pensions Supervisors (CEIOPS); 2. To achieve the tasks set out in paragraph 1, the Authority shall have the powers set out in this Regulation, in particular to: (a) develop draft regulatory technical standards in the specific cases referred to in Article 10; (b) develop draft implementing technical standards in the specific cases referred to in Article 15; (c) issue guidelines and recommendations, as laid down in Article 16; (d) issue recommendations in specific cases, as referred to in Article 17(3); (e) take individual decisions addressed to competent authorities in the specific cases referred to in Articles 18(3) and 19(3); (f) in cases concerning directly applicable Union law, take individual decisions addressed to financial institutions, in the specific cases referred to in Article 17(6), in Article 18(4) and in Article 19(4); (g) issue opinions to the European Parliament, the Council, or the Commission as provided for in Article 34; (h) collect the necessary information concerning financial institutions as provided for in Article 35; (i) develop common methodologies for assessing the effect of product characteristics and distribution processes on the financial position of institutions and on consumer protection; (j) provide a centrally accessible database of registered financial institutions in the area of its competence where specified in the acts referred to in Article 1(2). Article 9 Tasks related to consumer protection and financial activities 1. The Authority shall take a leading role in promoting transparency, simplicity and fairness in the market for consumer financial products or services across the internal market, including by: (a) collecting, analysing and reporting on consumer trends; (b) reviewing and coordinating financial literacy and education initiatives by the competent authorities; (c) developing training standards for the industry; and (d) contributing to the development of common disclosure rules. 2. The Authority shall monitor new and existing financial activities and may adopt guidelines and recommendations with a view to promoting the safety and soundness of markets and convergence of regulatory practice. 3. The Authority may also issue warnings in the event that a financial activity poses a serious threat to the objectives laid down in Article 1(6). 4. The Authority shall establish, as an integral part of the Authority, a Committee on financial innovation, which brings together all relevant competent national supervisory authorities with a view to achieving a coordinated approach to the regulatory and supervisory treatment of new or innovative financial activities and providing advice for the Authority to present to the European Parliament, the Council and the Commission. 5. The Authority may temporarily prohibit or restrict certain financial activities that threaten the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union in the cases specified and under the conditions laid down in the legislative acts referred to in Article 1(2) or, if so required, in the case of an emergency situation in accordance with and under the conditions laid down in Article 18. The Authority shall review the decision referred to in the first subparagraph at appropriate intervals and at least every 3 months. If the decision is not renewed after a three-month period, it shall automatically expire. A Member State may request the Authority to reconsider its decision. In that case, the Authority shall decide in accordance with the procedure set out in the second subparagraph of Article 44(1), whether it maintains its decision. The Authority may also assess the need to prohibit or restrict certain types of financial activity and, where there is such a need, inform the Commission in order to facilitate the adoption of any such prohibition or restriction. Article 10 Regulatory technical standards 1. Where the European Parliament and the Council delegate power to the Commission to adopt regulatory technical standards by means of delegated acts under Article 290 TFEU in order to ensure consistent harmonisation in the areas specifically set out in the legislative acts referred to in Article 1(2), the Authority may develop draft regulatory technical standards. The Authority shall submit its draft standards to the Commission for endorsement. Regulatory technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be delimited by the legislative acts on which they are based. Before submitting them to the Commission, the Authority shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Authority shall also request the opinion of the relevant stakeholder group referred to in Article 37. Where the Authority submits a draft regulatory technical standard, the Commission shall immediately forward it to the European Parliament and the Council. Within 3 months of receipt of a draft regulatory technical standard, the Commission shall decide whether to endorse it. The Commission may endorse the draft regulatory technical standards in part only, or with amendments, where the Union\u2019s interests so require. Where the Commission intends not to endorse a draft regulatory technical standard, or to endorse it in part or with amendments, it shall send the draft regulatory technical standard back to the Authority, explaining why it does not endorse it, or, as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard on the basis of the Commission\u2019s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If, on the expiry of that six-week period, the Authority has not submitted an amended draft regulatory technical standard, or has submitted a draft regulatory technical standard that is not amended in a way consistent with the Commission\u2019s proposed amendments, the Commission may adopt the regulatory technical standard with the amendments it considers relevant or reject it. The Commission may not change the content of a draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. 2. Where the Authority has not submitted a draft regulatory technical standard within the time limit set out in the legislative acts referred to in Article 1(2), the Commission may request such a draft within a new time limit. 3. Only where the Authority does not submit a draft regulatory technical standard to the Commission within the time limits in accordance with paragraph 2, may the Commission adopt a regulatory technical standard by means of a delegated act without a draft from the Authority. The Commission shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Commission shall also request the opinion or advice of the relevant stakeholder group referred to in Article 37. The Commission shall immediately forward the draft regulatory technical standard to the European Parliament and the Council. The Commission shall send its draft regulatory technical standard to the Authority. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard and submit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If, on the expiry of the six-week period referred to in the fourth subparagraph, the Authority has not submitted an amended draft regulatory technical standard, the Commission may adopt the regulatory technical standard. If the Authority has submitted an amended draft regulatory technical standard within the six-week period, the Commission may amend the draft regulatory technical standard on the basis of the Authority\u2019s proposed amendments or adopt the regulatory technical standard with the amendments it considers relevant. The Commission shall not change the content of the draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. 4. The regulatory technical standards shall be adopted by means of regulations or decisions. They shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. Article 11 Exercise of the delegation 1. The power to adopt regulatory technical standards referred to in Article 10 shall be conferred on the Commission for a period of four years from 16 December 2010. The Commission shall draw up a report in respect of the delegated power not later than 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 14. 2. As soon as it adopts a regulatory technical standard, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt regulatory technical standards is conferred on the Commission subject to the conditions laid down in Articles 12 to 14. Article 12 Revocation of the delegation 1. The delegation of power referred to in Article 10 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the regulatory technical standards already in force. It shall be published in the Official Journal of the European Union. Article 13 Objections to regulatory technical standards 1. The European Parliament or the Council may object to a regulatory technical standard within a period of 3 months from the date of notification of the regulatory technical standard adopted by the Commission. At the initiative of the European Parliament or the Council that period shall be extended by 3 months. Where the Commission adopts a regulatory technical standard which is the same as the draft regulatory technical standard submitted by the Authority, the period during which the European Parliament and the Council may object shall be 1 month from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 1 month. 2. If, on the expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the regulatory technical standard, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The regulatory technical standard may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a regulatory technical standard within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 TFEU, the institution which objects shall state the reasons for objecting to the regulatory technical standard. Article 14 Non-endorsement or amendment of draft regulatory technical standards 1. In the event that the Commission does not endorse a draft regulatory technical standard or amends it as provided for in Article 10, the Commission shall inform the Authority, the European Parliament and the Council, stating its reasons. 2. Where appropriate, the European Parliament or the Council may invite the responsible Commissioner, together with the Chairperson of the Authority, within 1 month of the notice referred to in paragraph 1, for an ad hoc meeting of the competent committee of the European Parliament or the Council to present and explain their differences. Article 15 Implementing technical standards 1. The Authority may develop implementing technical standards, by means of implementing acts under Article 291 TFEU, in the areas specifically set out in the legislative acts referred to in Article 1(2). Implementing technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be to determine the conditions of application of those acts. The Authority shall submit its draft implementing technical standards to the Commission for endorsement. Before submitting draft implementing technical standards to the Commission, the Authority shall conduct open public consultations and shall analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft implementing technical standards concerned or in relation to the particular urgency of the matter. The Authority shall also request the opinion of the relevant stakeholder group referred to in Article 37. Where the Authority submits a draft implementing technical standard, the Commission shall immediately forward it to the European Parliament and the Council. Within 3 months of receipt of a draft implementing technical standard, the Commission shall decide whether to endorse it. The Commission may extend that period by 1 month. The Commission may endorse the draft implementing technical standard in part only, or with amendments, where the Union\u2019s interests so require. Where the Commission intends not to endorse a draft implementing technical standard or intends to endorse it in part or with amendments, it shall send it back to the Authority explaining why it does not intend to endorse it, or, as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft implementing technical standard on the basis of the Commission\u2019s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If, on the expiry of the six-week period referred to in the fifth subparagraph, the Authority has not submitted an amended draft implementing technical standard, or has submitted a draft implementing technical standard that is not amended in a way consistent with the Commission\u2019s proposed amendments, the Commission may adopt the implementing technical standard with the amendments it considers relevant or reject it. The Commission shall not change the content of a draft implementing technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. 2. In cases where the Authority has not submitted a draft implementing technical standard within the time limit set out in the legislative acts referred to in Article 1(2), the Commission may request such a draft within a new time limit. 3. Only where the Authority does not submit a draft implementing technical standard to the Commission within the time limits in accordance with paragraph 2, may the Commission adopt an implementing technical standard by means of an implementing act without a draft from the Authority. The Commission shall conduct open public consultations on draft implementing technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft implementing technical standards concerned or in relation to the particular urgency of the matter. The Commission shall also request the opinion or advice of the relevant stakeholder group referred to in Article 37. The Commission shall immediately forward the draft implementing technical standard to the European Parliament and the Council. The Commission shall send the draft implementing technical standard to the Authority. Within a period of 6 weeks, the Authority may amend the draft implementing technical standard and submit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If, on the expiry of the six-week period referred to in the fourth subparagraph, the Authority has not submitted an amended draft implementing technical standard, the Commission may adopt the implementing technical standard. If the Authority has submitted an amended draft implementing technical standard within that six-week period, the Commission may amend the draft implementing technical standard on the basis of the Authority\u2019s proposed amendments or adopt the implementing technical standard with the amendments it considers relevant. The Commission shall not change the content of the draft implementing technical standards prepared by the Authority without prior coordination with the Authority, as set out in this Article. 4. The implementing technical standards shall be adopted by means of regulations or decisions. They shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. Article 16 Guidelines and recommendations 1. The Authority shall, with a view to establishing consistent, efficient and effective supervisory practices within the ESFS, and to ensuring the common, uniform and consistent application of Union law, issue guidelines and recommendations addressed to competent authorities or financial institutions. 2. The Authority shall, where appropriate, conduct open public consultations regarding the guidelines and recommendations and analyse the related potential costs and benefits. Such consultations and analyses shall be proportionate in relation to the scope, nature and impact of the guidelines or recommendations. The Authority shall, where appropriate, also request opinions or advice from the relevant stakeholder group referred to in Article 37. 3. The competent authorities and financial institutions shall make every effort to comply with those guidelines and recommendations. Within 2 months of the issuance of a guideline or recommendation, each competent authority shall confirm whether it complies or intends to comply with that guideline or recommendation. In the event that a competent authority does not comply or does not intend to comply, it shall inform the Authority, stating its reasons. The Authority shall publish the fact that a competent authority does not comply or does not intend to comply with that guideline or recommendation. The Authority may also decide, on a case-by-case basis, to publish the reasons provided by the competent authority for not complying with that guideline or recommendation. The competent authority shall receive advanced notice of such publication. If required by that guideline or recommendation, financial institutions shall report, in a clear and detailed way, whether they comply with that guideline or recommendation. 4. In the report referred to in Article 43(5) the Authority shall inform the European Parliament, the Council and the Commission of the guidelines and recommendations that have been issued, stating which competent authority has not complied with them, and outlining how the Authority intends to ensure that the competent authority concerned follow its recommendations and guidelines in the future. Article 17 Breach of Union law 1. Where a competent authority has not applied the acts referred to in Article 1(2) or has applied them in a way which appears to be a breach of Union law, including the regulatory technical standards and implementing technical standards established in accordance with Articles 10 to 15, in particular by failing to ensure that a financial institution satisfies the requirements laid down in those acts, the Authority shall act in accordance with the powers set out in paragraphs 2, 3 and 6 of this Article. 2. Upon a request from one or more competent authorities, the European Parliament, the Council, the Commission or the relevant stakeholder group, or on its own initiative and after having informed the competent authority concerned, the Authority may investigate the alleged breach or non-application of Union law. Without prejudice to the powers laid down in Article 35, the competent authority shall, without delay, provide the Authority with all information which the Authority considers necessary for its investigation. 3. The Authority may, not later than 2 months from initiating its investigation, address a recommendation to the competent authority concerned setting out the action necessary to comply with Union law. The competent authority shall, within ten working days of receipt of the recommendation, inform the Authority of the steps it has taken or intends to take to ensure compliance with Union law. 4. Where the competent authority has not complied with Union law within 1 month from receipt of the Authority\u2019s recommendation, the Commission may, after having been informed by the Authority, or on its own initiative, issue a formal opinion requiring the competent authority to take the action necessary to comply with Union law. The Commission\u2019s formal opinion shall take into account the Authority\u2019s recommendation. The Commission shall issue such a formal opinion no later than 3 months after the adoption of the recommendation. The Commission may extend this period by 1 month. The Authority and the competent authorities shall provide the Commission with all necessary information. 5. The competent authority shall, within ten working days of receipt of the formal opinion referred to in paragraph 4, inform the Commission and the Authority of the steps it has taken or intends to take to comply with that formal opinion. 6. Without prejudice to the powers of the Commission under Article 258 TFEU, where a competent authority does not comply with the formal opinion referred to in paragraph 4 within the period of time specified therein, and where it is necessary to remedy in a timely manner such non-compliance in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system, the Authority may, where the relevant requirements of the acts referred to in Article 1(2) are directly applicable to financial institutions, adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under Union law including the cessation of any practice. The decision of the Authority shall be in conformity with the formal opinion issued by the Commission pursuant to paragraph 4. 7. Decisions adopted under paragraph 6 shall prevail over any previous decision adopted by the competent authorities on the same matter. When taking action in relation to issues which are subject to a formal opinion pursuant to paragraph 4 or a decision pursuant to paragraph 6, competent authorities shall comply with the formal opinion or the decision, as the case may be. 8. In the report referred to in Article 43(5), the Authority shall set out which competent authorities and financial institutions have not complied with the formal opinions or decisions referred to in paragraphs 4 and 6 of this Article. Article 18 Action in emergency situations 1. In the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union, the Authority shall actively facilitate and, where deemed necessary, coordinate any actions undertaken by the relevant national competent supervisory authorities. In order to be able to perform that facilitating and coordinating role, the Authority shall be fully informed of any relevant developments, and shall be invited to participate as an observer in any relevant gathering by the relevant national competent supervisory authorities. 2. The Council, in consultation with the Commission and the ESRB and, where appropriate, the ESAs, may adopt a decision addressed to the Authority, determining the existence of an emergency situation for the purposes of this Regulation, following a request by the Authority, the Commission or the ESRB. The Council shall review that decision at appropriate intervals and at least once a month. If the decision is not renewed at the end of a one-month period, it shall automatically expire. The Council may declare the discontinuation of the emergency situation at any time. Where the ESRB or the Authority considers that an emergency situation may arise, it shall issue a confidential recommendation addressed to the Council and provide it with an assessment of the situation. The Council shall then assess the need for a meeting. In that process, due care of confidentiality shall be guaranteed. If the Council determines the existence of an emergency situation, it shall duly inform the European Parliament and the Commission without delay. 3. Where the Council has adopted a decision pursuant to paragraph 2, and in exceptional circumstances where coordinated action by national authorities is necessary to respond to adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union, the Authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in Article 1(2) to address any such developments by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation. 4. Without prejudice to the powers of the Commission under Article 258 TFEU, where a competent authority does not comply with the decision of the Authority referred to in paragraph 3 within the period laid down in that decision, the Authority may, where the relevant requirements laid down in the legislative acts referred to in Article 1(2) including in regulatory technical standards and implementing technical standards adopted in accordance with those acts are directly applicable to financial institutions, adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under that legislation, including the cessation of any practice. This shall apply only in situations in which a competent authority does not apply the legislative acts referred to in Article 1(2), including regulatory technical standards and implementing technical standards adopted in accordance with those acts, or applies them in a way which appears to be a manifest breach of those acts, and where urgent remedying is necessary to restore the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union. 5. Decisions adopted under paragraph 4 shall prevail over any previous decision adopted by the competent authorities on the same matter. Any action by the competent authorities in relation to issues which are subject to a decision pursuant to paragraph 3 or 4 shall be compatible with those decisions. Article 19 Settlement of disagreements between competent authorities in cross-border situations 1. Without prejudice to the powers laid down in Article 17, where a competent authority disagrees about the procedure or content of an action or inaction of a competent authority of another Member State in cases specified in the acts referred to in Article 1(2), the Authority, at the request of one or more of the competent authorities concerned, may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraphs 2 to 4 of this Article. In cases specified in the legislation referred to in Article 1(2), and where on the basis of objective criteria, disagreement between competent authorities from different Member States can be determined, the Authority may, on its own initiative, assist the authorities in reaching an agreement in accordance with the procedure set out in paragraphs 2 to 4. 2. The Authority shall set a time limit for conciliation between the competent authorities taking into account any relevant time periods specified in the acts referred to in Article 1(2) and the complexity and urgency of the matter. At that stage the Authority shall act as a mediator. 3. If the competent authorities concerned fail to reach an agreement within the conciliation phase referred to in paragraph 2, the Authority may, in accordance with the procedure set out in the third and fourth subparagraph of Article 44(1) take a decision requiring them to take specific action or to refrain from action in order to settle the matter, with binding effects for the competent authorities concerned, in order to ensure compliance with Union law. 4. Without prejudice to the powers of the Commission under Article 258 TFEU, where a competent authority does not comply with the decision of the Authority, and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the acts referred to in Article 1(2), the Authority may adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under Union law, including the cessation of any practice. 5. Decisions adopted under paragraph 4 shall prevail over any previous decision adopted by the competent authorities on the same matter. Any action by the competent authorities in relation to facts which are subject to a decision pursuant to paragraph 3 or 4 shall be compatible with those decisions. 6. In the report referred to in Article 50(2), the Chairperson of the Authority shall set out the nature and type of disagreements between competent authorities, the agreements reached and the decisions taken to settle such disagreements. Article 20 Settlement of disagreements between competent authorities across sectors The Joint Committee shall, in accordance with the procedure laid down in Article 19 and Article 56, settle cross-sectoral disagreements that may arise between competent authorities as defined in Article 4(2) of this Regulation, of Regulation (EU) No 1093/2010 and of Regulation (EU) No 1095/2010 respectively. Article 21 Colleges of supervisors 1. The Authority shall contribute to promoting and monitoring the efficient, effective and consistent functioning of the colleges of supervisors referred to in Directive 2009/138/EC and foster the coherence of the application of Union law among the colleges of supervisors. With the objective of converging supervisory best practices, staff from the Authority shall be able to participate in the activities of the colleges of supervisors, including on-site examinations, carried out jointly by two or more competent authorities. 2. The Authority shall lead in ensuring a consistent and coherent functioning of colleges of supervisors for cross-border institutions across the Union, taking account of the systemic risk posed by financial institutions referred to in Article 23. For the purpose of this paragraph and of paragraph 1 of this Article, the Authority shall be considered a \u2018competent authority\u2019 within the meaning of the relevant legislation. The Authority may: (a) collect and share all relevant information in cooperation with the competent authorities in order to facilitate the work of the college and establish and manage a central system to make such information accessible to the competent authorities in the college; (b) initiate and coordinate Union-wide stress tests in accordance with Article 32 to assess the resilience of financial institutions, in particular the systemic risk posed by financial institutions as referred to in Article 23, to adverse market developments, and evaluate the potential for systemic risk to increase in situations of stress, ensuring that a consistent methodology is applied at the national level to such tests and, where appropriate, address a recommendation to the competent authority to correct issues identified in the stress test; (c) promote effective and efficient supervisory activities, including evaluating the risks to which financial institutions are or might be exposed as determined under the supervisory review process or in stress situations; (d) oversee, in accordance with the tasks and powers specified in this Regulation, the tasks carried out by the competent authorities; and (e) request further deliberations of a college in any cases where it considers that the decision would result in an incorrect application of Union law or would not contribute to the objective of convergence of supervisory practices. It may also require the group supervisor to schedule a meeting of the college or add a point to the agenda of a meeting. 3. The Authority may develop draft regulatory and implementing technical standards to ensure uniform conditions of application with respect to the provisions regarding the operational functioning of colleges of supervisors and issue guidelines and recommendations adopted under Article 16 to promote convergence in supervisory functioning and best practices adopted by the colleges of supervisors. 4. The Authority shall have a legally binding mediation role to resolve disputes between competent authorities in accordance with the procedure set out in Article 19. The Authority may take supervisory decisions directly applicable to the institution concerned in accordance with Article 19. Article 22 General provisions 1. The Authority shall duly consider systemic risk as defined by Regulation (EU) No 1092/2010. It shall address any risk of disruption in financial services that: (a) is caused by an impairment of all or parts of the financial system; and (b) has the potential to have serious negative consequences for internal market and the real economy. The Authority shall consider, where appropriate, the monitoring and assessment of systemic risk as developed by the ESRB and the Authority and respond to warnings and recommendations by the ESRB in accordance with Article 17 of Regulation (EU) No 1092/2010. 2. The Authority shall, in collaboration with the ESRB, and in accordance with Article 23(1), develop a common approach to the identification and measurement of systemic importance, including quantitative and qualitative indicators as appropriate. These indicators shall be a critical element in the determination of appropriate supervisory actions. The Authority shall monitor the degree of convergence in the determinations made, with a view to promoting a common approach. 3. Without prejudice to the acts referred to in Article 1(2), the Authority shall draw up, as necessary, additional guidelines and recommendations for financial institutions, to take account of the systemic risk posed by them. The Authority shall ensure that the systemic risk posed by financial institutions is taken into account when developing draft regulatory and implementing technical standards in the areas laid down in the legislative acts referred to in Article 1(2). 4. Upon a request from one or more competent authorities, the European Parliament, the Council or the Commission, or on its own initiative, the Authority may conduct an inquiry into a particular type of financial institution or type of product or type of conduct in order to assess potential threats to the stability of the financial system and make appropriate recommendations for action to the competent authorities concerned. For those purposes, the Authority may use the powers conferred on it under this Regulation, including Article 35. 5. The Joint Committee shall ensure overall and cross-sectoral coordination of the activities carried out in accordance with this Article. Article 23 Identification and measurement of systemic risk 1. The Authority shall, in consultation with the ESRB, develop criteria for the identification and measurement of systemic risk and an adequate stress testing regime which includes an evaluation of the potential for systemic risk that may be posed by financial institutions to increase in situations of stress. The Authority shall develop an adequate stress testing regime to help identify those financial institutions that may pose a systemic risk. These institutions shall be subject to strengthened supervision, and where necessary, to the recovery and resolution procedures referred to in Article 25. 2. The Authority shall take fully into account the relevant international approaches when developing the criteria for the identification and measurement of systemic risk that may be posed by insurance, re-insurance and occupational pensions institutions, including those established by the Financial Stability Board, the International Monetary Fund, the International Association of Insurance Supervisors and the Bank for International Settlements. Article 24 Permanent capacity to respond to systemic risks 1. The Authority shall ensure it has specialised and ongoing capacity to respond effectively to the materialisation of systemic risks as referred to in Articles 22 and 23, in particular with respect to institutions that pose a systemic risk. 2. The Authority shall fulfil the tasks conferred upon it in this Regulation and in the legislation referred to in Article 1(2), and shall contribute to ensuring a coherent and coordinated crisis management and resolution regime in the Union. Article 25 Recovery and resolution procedures 1. The Authority shall contribute to and participate actively in the development and coordination of effective and consistent recovery and resolution plans, procedures in emergency situations and preventive measures to minimise the systemic impact of any failure. 2. The Authority may identify best practices aimed at facilitating the resolution of failing institutions and, in particular, cross-border groups, in ways which avoid contagion, ensuring that appropriate tools, including sufficient resources, are available and allow the institution or the group to be resolved in an orderly, cost-efficient and timely manner. 3. The Authority may develop regulatory and implementing technical standards as specified in the legislative acts referred to in Article 1(2) in accordance with the procedure laid down in Articles 10 to 15. Article 26 Development of a European network of national insurance guarantee schemes The Authority may contribute to the assessment of the need for a European network of national insurance guarantee schemes which is adequately funded and sufficiently harmonised. Article 27 Crisis prevention, management and resolution The Authority may be requested by the Commission to contribute to the assessment referred to in Article 242 of Directive 2009/138/EC, in particular as regards the cooperation of supervisory authorities within, and functionality of, colleges of supervisors; the supervisory practices concerning setting the capital add-ons; the assessment of the benefit of enhancing group supervision and capital management within a group of insurance or reinsurance undertakings, including possible measures to enhance a sound cross-border management of insurance groups, in particular in respect of risks and asset management; and may report on any new developments and progress concerning: (a) a harmonised framework for early intervention; (b) practices in centralised group risk management and functioning of group internal models including stress testing; (c) intra-group transactions and risk concentrations; (d) the behaviour of diversification and concentration effects over time; (e) a harmonised framework for asset transferability, insolvency and winding-up procedures which eliminates the relevant national company or corporate law barriers to asset transferability; (f) an equivalent level of protection of policy holders and beneficiaries of the undertakings of the same group, particularly in crisis situations; (g) a harmonised and adequately funded Union-wide solution for insurance guarantee schemes. Having regard to point (f), the Authority may also report on any new developments and progress concerning a set of coordinated national crisis management arrangements and including the necessity or otherwise of a system of coherent and credible funding mechanisms, with appropriate financing instruments. The review of this Regulation provided for in Article 81 shall, in particular, examine the possible enhancement of the role of the Authority in a framework of crisis prevention, management and resolution. Article 28 Delegation of tasks and responsibilities 1. Competent authorities may, with the consent of the delegate, delegate tasks and responsibilities to the Authority or other competent authorities subject to the conditions set out in this Article. Member States may set out specific arrangements regarding the delegation of responsibilities that have to be complied with before their competent authorities enter into such delegation agreements, and may limit the scope of delegation to what is necessary for the effective supervision of cross-border financial institutions or groups. 2. The Authority shall stimulate and facilitate the delegation of tasks and responsibilities between competent authorities by identifying those tasks and responsibilities that can be delegated or jointly exercised and by promoting best practices. 3. The delegation of responsibilities shall result in the reallocation of competences laid down in the acts referred to in Article 1(2). The law of the delegate authority shall govern the procedure, enforcement and administrative and judicial review relating to the delegated responsibilities. 4. The competent authorities shall inform the Authority of delegation agreements into which they intend to enter. They shall put the agreements into effect at the earliest 1 month after informing the Authority. The Authority may give an opinion on the intended agreement within 1 month of being informed. The Authority shall publish, by appropriate means, any delegation agreement as concluded by the competent authorities, in order to ensure that all parties concerned are informed appropriately. Article 29 Common supervisory culture 1. The Authority shall play an active role in building a common Union supervisory culture and consistent supervisory practices, as well as in ensuring uniform procedures and consistent approaches throughout the Union. The Authority shall carry out, at a minimum, the following activities: (a) providing opinions to competent authorities; (b) promoting an effective bilateral and multilateral exchange of information between competent authorities, with full respect for the applicable confidentiality and data protection provisions provided for in the relevant Union legislation; (c) contributing to developing high quality and uniform supervisory standards, including reporting standards, and international accounting standards in accordance with Article 1(3); (d) reviewing the application of the relevant regulatory and implementing technical standards adopted by the Commission, and of the guidelines and recommendations issued by the Authority and proposing amendments where appropriate; and (e) establishing sectoral and cross-sectoral training programmes, facilitating personnel exchanges and encouraging competent authorities to intensify the use of secondment schemes and other tools. 2. The Authority may, as appropriate, develop new practical instruments and convergence tools to promote common supervisory approaches and practices. Article 30 Peer reviews of competent authorities 1. The Authority shall periodically organise and conduct peer reviews of some or all of the activities of competent authorities, to further strengthen consistency in supervisory outcomes. To that end, the Authority shall develop methods to allow for objective assessment and comparison between the authorities reviewed. When conducting peer reviews, existing information and evaluations already made with regard to the competent authority concerned shall be taken into account. 2. The peer review shall include an assessment of, but shall not be limited to: (a) the adequacy of resources and governance arrangements of the competent authority, with particular regard to the effective application of the regulatory technical standards and implementing technical standards referred to in Articles 10 to 15 and of the acts referred to in Article 1(2) and the capacity to respond to market developments; (b) the degree of convergence reached in the application of Union law and in supervisory practice, including regulatory technical standards and implementing technical standards, guidelines and recommendations adopted under Articles 10 to 16, and the extent to which the supervisory practice achieves the objectives set out in Union law; (c) best practices developed by some competent authorities which might be of benefit for other competent authorities to adopt; (d) the effectiveness and the degree of convergence reached with regard to the enforcement of the provisions adopted in the implementation of Union law, including the administrative measures and sanctions imposed against persons responsible where those provisions have not been complied with. 3. On the basis of a peer review, the Authority may issue guidelines and recommendations pursuant to Article 16. In accordance with Article 16(3), the competent authorities shall endeavour to follow those guidelines and recommendations. The Authority shall take into account the outcome of the peer review when developing draft regulatory technical or implementing technical standards in accordance with Articles 10 to 15. 4. The Authority shall make the best practices that can be identified from those peer reviews publicly available. In addition, all other results of peer reviews may be disclosed publicly, subject to the agreement of the competent authority that is the subject of the peer review. Article 31 Coordination function The Authority shall fulfil a general coordination role between competent authorities, in particular in situations where adverse developments could potentially jeopardise the orderly functioning and integrity of financial markets or the stability of the financial system in the Union. The Authority shall promote a coordinated Union response, inter alia, by: (a) facilitating the exchange of information between the competent authorities; (b) determining the scope and, where possible and appropriate, verifying the reliability of information that should be made available to all the competent authorities concerned; (c) without prejudice to Article 19, carrying out non-binding mediation upon a request from the competent authorities or on its own initiative; (d) notifying the ESRB of any potential emergency situations without delay; (e) taking all appropriate measures in case of developments which may jeopardise the functioning of the financial markets with a view to facilitating the coordination of actions undertaken by relevant competent authorities; (f) centralising information received from competent authorities in accordance with Articles 21 and 35 as the result of the regulatory reporting obligations for institutions active in more than one Member State. The Authority shall share that information with the other competent authorities concerned. Article 32 Assessment of market developments 1. The Authority shall monitor and assess market developments in the area of its competence and, where necessary, inform the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Securities and Markets Authority), the ESRB and the European Parliament, the Council and the Commission about the relevant micro-prudential trends, potential risks and vulnerabilities. The Authority shall include in its assessments an economic analysis of the markets in which financial institutions operate and an assessment of the impact of potential market developments on such institutions. 2. The Authority shall, in cooperation with the ESRB, initiate and coordinate Union-wide assessments of the resilience of financial institutions to adverse market developments. To that end, it shall develop the following, for application by the competent authorities: (a) common methodologies for assessing the effect of economic scenarios on an institution\u2019s financial position; (b) common approaches to communication on the outcomes of these assessments of the resilience of financial institutions; (c) common methodologies for assessing the effect of particular products or distribution processes on an institution\u2019s financial position and on policyholders, pension scheme members, beneficiaries and customer information. 3. Without prejudice to the tasks of the ESRB set out in Regulation (EU) No 1092/2010, the Authority shall, at least once a year, and more frequently as necessary, provide assessments to the European Parliament, the Council, the Commission and the ESRB of trends, potential risks and vulnerabilities in its area of competence. The Authority shall include a classification of the main risks and vulnerabilities in these assessments and, where necessary, recommend preventative or remedial actions. 4. The Authority shall ensure an adequate coverage of cross-sectoral developments, risks and vulnerabilities by closely cooperating with the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Securities and Markets Authority) through the Joint Committee. Article 33 International relations 1. Without prejudice to the respective competences of the Member States and the Union institutions, the Authority may develop contacts and enter into administrative arrangements with supervisory authorities, international organisations and the administrations of third countries. Those arrangements shall not create legal obligations in respect of the Union and its Member States nor shall they prevent Member States and their competent authorities from concluding bilateral or multilateral arrangements with those third countries. 2. The Authority shall assist in preparing equivalence decisions pertaining to supervisory regimes in third countries in accordance with the acts referred to in Article 1(2). 3. In the report referred to in Article 43(5), the Authority shall set out the administrative arrangements agreed upon with international organisations or administrations in third countries and the assistance provided in preparing equivalence decisions. Article 34 Other tasks 1. The Authority may, upon a request from the European Parliament, the Council or the Commission, or on its own initiative, provide opinions to the European Parliament, the Council and the Commission on all issues related to its area of competence. 2. With regard to prudential assessments of mergers and acquisitions falling within the scope of Directive 92/49/EEC and Directives 2002/83/EC and 2005/68/EC, as amended by Directive 2007/44/EC, and which, according to those Directives, require consultation between competent authorities from two or more Member States, the Authority may, on application of one of the competent authorities concerned, issue and publish an opinion on a prudential assessment, except in relation to the criteria in Article 15b(1)(e) of Directive 92/49/EEC, Article 15b(1)(e) of Directive 2002/83/EC and Article 19a(1)(e) of Directive 2005/68/EC. The opinion shall be issued promptly and in any event before the end of the assessment period in accordance with Directive 92/49/EEC and Directives 2002/83/EC and 2005/68/EC, as amended by Directive 2007/44/EC. Article 35 shall apply to the areas in respect of which the Authority may issue an opinion. Article 35 Collection of information 1. At the request of the Authority, the competent authorities of the Member States shall provide the Authority with all the necessary information to carry out the duties assigned to it by this Regulation, provided that they have legal access to the relevant information and that the request for information is necessary in relation to the nature of the duty in question. 2. The Authority may also request information to be provided at recurring intervals and in specified formats. Such requests shall, where possible, be made using common reporting formats. 3. Upon a duly justified request from a competent authority of a Member State, the Authority may provide any information that is necessary to enable the competent authority to carry out its duties, in accordance with the professional secrecy obligations laid down in sectoral legislation and in Article 70. 4. Before requesting information in accordance with this Article and in order to avoid the duplication of reporting obligations, the Authority shall take account of any relevant existing statistics produced and disseminated by the European Statistical System and the European System of Central Banks. 5. Where information is not available or is not made available by the competent authorities in a timely fashion, the Authority may address a duly justified and reasoned request to other supervisory authorities, to the ministry responsible for finance where it has at its disposal prudential information, to the national central bank or to the statistical office of the Member State concerned. 6. Where information is not available or is not made available under paragraph 1 or 5 in a timely fashion, the Authority may address a duly justified and reasoned request directly to the relevant financial institutions. The reasoned request shall explain why the information concerning the respective individual financial institutions is necessary. The Authority shall inform the relevant competent authorities of requests in accordance with this paragraph and with paragraph 5. At the request of the Authority, the competent authorities shall assist the Authority in collecting the information. 7. The Authority may use confidential information received under this Article only for the purposes of carrying out the duties assigned to it by this Regulation. Article 36 Relationship with the ESRB 1. The Authority shall cooperate closely and on a regular basis with the ESRB. 2. The Authority shall provide the ESRB with regular and timely information necessary for the achievement of its tasks. Any data necessary for the achievement of its tasks that are not in summary or aggregate form shall be provided, without delay, to the ESRB upon a reasoned request, as specified in Article 15 of Regulation (EU) No 1092/2010. The Authority, in cooperation with the ESRB, shall have in place adequate internal procedures for the transmission of confidential information, in particular information regarding individual financial institutions. 3. The Authority shall, in accordance with paragraphs 4 and 5, ensure a proper follow-up to ESRB warnings and recommendations referred to in Article 16 of Regulation (EU) No 1092/2010. 4. On receipt of a warning or recommendation from the ESRB addressed to the Authority, the Authority shall convene a meeting of the Board of Supervisors without delay and assess the implications of such a warning or recommendation for the fulfilment of its tasks. It shall decide, by the relevant decision-making procedure, on any actions to be taken in accordance with the powers conferred upon it by this Regulation for addressing the issues identified in the warnings and recommendations. If the Authority does not act on a recommendation, it shall explain to the ESRB and the Council its reasons for not doing so. 5. On receipt of a warning or recommendation from the ESRB addressed to a competent national supervisory authority, the Authority shall, where relevant, use the powers conferred upon it by this Regulation to ensure a timely follow-up. Where the addressee intends not to follow the recommendation of the ESRB, it shall inform and discuss with the Board of Supervisors its reasons for not acting. The competent authority shall take due account of the views of the Board of Supervisors when informing the Council and the ESRB in accordance with Article 17 of Regulation (EU) No 1092/2010. 6. In discharging the tasks set out in this Regulation, the Authority shall take the utmost account of the warnings and recommendations of the ESRB. Article 37 Insurance and Reinsurance Stakeholder Group and Occupational Pensions Stakeholder Group 1. To help facilitate consultation with stakeholders in areas relevant to the tasks of the Authority, an Insurance and Reinsurance Stakeholder Group and an Occupational Pensions Stakeholder Group shall be established (hereinafter collectively referred to as the \u2018Stakeholder Groups\u2019). The Stakeholder Groups shall be consulted on actions taken in accordance with Articles 10 to 15 concerning regulatory technical standards and implementing technical standards, and, to the extent that these do not concern individual financial institutions, Article 16 concerning guidelines and recommendations. If actions must be taken urgently and consultation becomes impossible, the Stakeholder Groups shall be informed as soon as possible. The Stakeholder Groups shall meet at least four times a year. They may, together, discuss areas of mutual interest and shall inform each other of the other issues being discussed. Members of one stakeholder group may be also members of the other stakeholder group. 2. The Insurance and Reinsurance Stakeholder Group shall be composed of 30 members, representing in balanced proportions insurance and reinsurance undertakings and insurance intermediaries operating in the Union, and their employees\u2019 representatives, as well as consumers, users of insurance and reinsurance services, representatives of SMEs and representatives of relevant professional associations. At least five of its members shall be independent top-ranking academics. Ten of its members shall represent insurance undertakings, reinsurance undertakings or insurance intermediaries, three of whom shall represent cooperative and mutual insurers or reinsurers. 3. The Occupational Pensions Stakeholder Group shall be composed of 30 members, representing in balanced proportions institutions for occupational retirement provision operating in the Union, representatives of employees, representatives of beneficiaries, representatives of SMEs and representatives of relevant professional associations. At least five of its members shall be independent top-ranking academics. Ten of its members shall represent institutions for occupational retirement provision. 4. The members of the Stakeholder Groups shall be appointed by the Board of Supervisors, following proposals from the relevant stakeholders. In making its decision, the Board of Supervisors shall, to the extent possible, ensure an appropriate geographical and gender balance and representation of stakeholders across the Union. 5. The Authority shall provide all necessary information subject to professional secrecy as set out in Article 70 and ensure adequate secretarial support for the Stakeholder Groups. Adequate compensation shall be provided to members of the Stakeholder Groups representing non-profit organisations, excluding industry representatives. The Stakeholder Groups may establish working groups on technical issues. Members of the Stakeholder Groups shall serve for a period of two-and-a-half years, following which a new selection procedure shall take place. The members of the Stakeholder Groups may serve two successive terms. 6. The Stakeholder Groups may submit opinions and advice to the Authority on any issue related to the tasks of the Authority with particular focus on the tasks set out in Articles 10 to 16, and Articles 29, 30 and 32. 7. The Stakeholder Groups shall adopt their rules of procedure on the basis of the agreement of a two-thirds majority of their respective members. 8. The Authority shall make public the opinions and advice of the Stakeholder Groups and the results of their consultations. Article 38 Safeguards 1. The Authority shall ensure that no decision adopted under Articles 18 or 19 impinges in any way on the fiscal responsibilities of Member States. 2. Where a Member State considers that a decision taken under Article 19(3) impinges on its fiscal responsibilities, it may notify the Authority and the Commission within 2 weeks after notification of the Authority\u2019s decision to the competent authority that the decision will not be implemented by the competent authority. In its notification, the Member State shall clearly and specifically explain why and how the decision impinges on its fiscal responsibilities. In the case of such notification, the decision of the Authority shall be suspended. Within a period of 1 month from the notification by the Member State, the Authority shall inform the Member State as to whether it maintains its decision or whether it amends or revokes it. If the decision is maintained or amended, the Authority shall state that fiscal responsibilities are not affected. Where the Authority maintains its decision, the Council shall take a decision, by a majority of the votes cast, at one of its meetings not later than 2 months after the Authority has informed the Member State as set out in the fourth subparagraph, as to whether the Authority\u2019s decision is maintained. Where the Council, after having considered the matter, does not take a decision to maintain the Authority\u2019s decision in accordance with the fifth subparagraph, the Authority\u2019s decision shall be terminated. 3. Where a Member State considers that a decision taken under Article 18(3) impinges on its fiscal responsibilities, it may notify the Authority, the Commission and the Council, within three working days after notification of the Authority\u2019s decision to the competent authority, that the decision will not be implemented by the competent authority. In its notification, the Member State shall clearly and specifically explain why and how the decision impinges on its fiscal responsibilities. In the case of such notification, the decision of the Authority shall be suspended. The Council shall, within ten working days, convene a meeting and take a decision, by a simple majority of its members, as to whether the Authority\u2019s decision is revoked. Where the Council, after having considered the matter, does not take a decision to revoke the Authority\u2019s decision in accordance with the fourth subparagraph, the suspension of the Authority\u2019s decision shall be terminated. 4. Where the Council has taken a decision in accordance with paragraph 3 not to revoke a decision of the Authority relating to Article 18(3), and the Member State concerned still considers that the decision of the Authority impinges upon its fiscal responsibilities, that Member State may notify the Commission and the Authority and request the Council to re-examine the matter. The Member State concerned shall clearly set out the reasons for its disagreement with the decision of the Council. Within a period of 4 weeks after the notification referred to in the first subparagraph, the Council shall confirm its original decision or take a new decision in accordance with paragraph 3. The period of 4 weeks may be extended by four additional weeks by the Council, if the particular circumstances of the case so require. 5. Any abuse of this Article, in particular in relation to a decision by the Authority which does not have a significant or material fiscal impact, shall be prohibited as incompatible with the internal market. Article 39 Decision-making procedures 1. Before taking the decisions provided for in this Regulation, the Authority shall inform any named addressee of its intention to adopt the decision, setting a time limit within which the addressee may express its views on the matter, taking full account of the urgency, complexity and potential consequences of the matter. This applies mutatis mutandis to recommendations as referred to in Article 17(3). 2. The decisions of the Authority shall state the reasons on which they are based. 3. The addressees of decisions of the Authority shall be informed of the legal remedies available under this Regulation. 4. Where the Authority has taken a decision pursuant to Article 18(3) or (4), it shall review that decision at appropriate intervals. 5. The decisions which the Authority takes pursuant to Articles 17, 18 or 19 shall be made public and shall state the identity of the competent authority or financial institution concerned and the main content of the decision, unless such publication is in conflict with the legitimate interests of financial institutions in the protection of their business secrets or could seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system of the Union. CHAPTER III ORGANISATION SECTION 1 Board of Supervisors Article 40 Composition 1. The Board of Supervisors shall be composed of: (a) the Chairperson, who shall be non-voting; (b) the head of the national public authority competent for the supervision of financial institutions in each Member State, who shall meet in person at least twice a year; (c) one representative of the Commission, who shall be non-voting; (d) one representative of the ESRB, who shall be non-voting; (e) one representative of each of the other two European Supervisory Authorities, who shall be non-voting; 2. The Board of Supervisors shall convene meetings with the Stakeholder Groups regularly, at least twice a year. 3. Each competent authority shall be responsible for nominating a high-level alternate from its authority, who may replace the member of the Board of Supervisors referred to in paragraph 1(b), where that person is prevented from attending. 4. In Member States where more than one authority is responsible for the supervision according to this Regulation, those authorities shall agree on a common representative. Nevertheless, when an item to be discussed by the Board of Supervisors does not fall within the competence of the national authority being represented by the member referred to in paragraph 1(b), that member may bring a representative from the relevant national authority, who shall be non-voting. 5. The Board of Supervisors may decide to admit observers. The Executive Director may participate in meetings of the Board of Supervisors, without the right to vote. Article 41 Internal committees and panels 1. The Board of Supervisors may establish internal committees or panels for specific tasks attributed to the Board of Supervisors, and may provide for the delegation of certain clearly defined tasks and decisions to internal committees or panels, to the Management Board or to the Chairperson. 2. For the purposes of Article 19, the Board of Supervisors shall convoke an independent panel to facilitate an impartial settlement of the disagreement, consisting of the Chairperson and two of its members, who are not representatives of the competent authorities which are party to the disagreement and who have neither any interest in the conflict nor direct links to the competent authorities concerned. 3. Subject to Article 19(2), the panel shall propose a decision for final adoption by the Board of Supervisors, in accordance with the procedure set out in the third subparagraph of Article 44(1). 4. The Board of Supervisors shall adopt rules of procedure for the panel referred to in paragraph 2. Article 42 Independence When carrying out the tasks conferred upon it by this Regulation, the Chairperson and the voting members of the Board of Supervisors shall act independently and objectively in the sole interest of the Union as a whole and shall neither seek nor take instructions from Union institutions or bodies, from any government of a Member State or from any other public or private body. Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the members of the Board of Supervisors in the performance of their tasks. Article 43 Tasks 1. The Board of Supervisors shall give guidance to the work of the Authority and shall be in charge of taking the decisions referred to in Chapter II. 2. The Board of Supervisors shall adopt the opinions, recommendations, and decisions, and issue the advice referred to in Chapter II. 3. The Board of Supervisors shall appoint the Chairperson. 4. The Board of Supervisors shall adopt, before 30 September of each year, on the basis of a proposal by the Management Board, the work programme of the Authority for the coming year, and shall transmit it for information to the European Parliament, the Council and the Commission. The work programme shall be adopted without prejudice to the annual budgetary procedure and shall be made public. 5. The Board of Supervisors shall, on the basis of a proposal by the Management Board, adopt the annual report on the activities of the Authority, including on the performance of the Chairperson\u2019s duties, on the basis of the draft report referred to in Article 53(7) and shall transmit that report to the European Parliament, the Council, the Commission, the Court of Auditors and the European Economic and Social Committee by 15 June each year. The report shall be made public. 6. The Board of Supervisors shall adopt the multi-annual work programme of the Authority, and shall transmit it for information to the European Parliament, the Council and the Commission. The multi-annual work programme shall be adopted without prejudice to the annual budgetary procedure and shall be made public. 7. The Board of Supervisors shall adopt the budget in accordance with Article 63. 8. The Board of Supervisors shall exercise disciplinary authority over the Chairperson and the Executive Director and may remove them from office in accordance with Article 48(5) or Article 51(5) respectively. Article 44 Decision making 1. Decisions of the Board of Supervisors shall be taken by a simple majority of its members. Each member shall have one vote. With regard to the acts specified in Articles 10 to 16 and measures and decisions adopted under the third subparagraph of Article 9(5) and Chapter VI and by way of derogation from the first subparagraph of this paragraph, the Board of Supervisors shall take decisions on the basis of a qualified majority of its members, as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions. With regard to decisions in accordance with Article 19(3), for decisions taken by the group supervisor, the decision proposed by the panel shall be considered as adopted, if approved by a simple majority, unless it is rejected by members representing a blocking minority of the votes as defined in Article 16(4) of the Treaty on European Union and in Article 3 of the Protocol (No 36) on transitional provisions. For all other decisions in accordance with Article 19(3), the decision proposed by the panel shall be adopted by a simple majority of the members of the Board of Supervisors. Each member shall have one vote. 2. Meetings of the Board of Supervisors shall be convened by the Chairperson at his own initiative or at the request of one third of its members, and shall be chaired by the Chairperson. 3. The Board of Supervisors shall adopt and make public its rules of procedure. 4. The rules of procedure shall set out in detail the arrangements governing voting, including, where appropriate, the rules governing quorums. The non-voting members and the observers, with the exception of the Chairperson and the Executive Director, shall not attend any discussions within the Board of Supervisors relating to individual financial institutions, unless otherwise provided for in Article 75(3) or in the acts referred to in Article 1(2). SECTION 2 Management Board Article 45 Composition 1. The Management Board shall be composed of the Chairperson and six other members of the Board of Supervisors, elected by and from the voting members of the Board of Supervisors. Other than the Chairperson, each member of the Management Board shall have an alternate, who may replace him if he is prevented from attending. The term of office of the members elected by the Board of Supervisors shall be two-and-a-half years. That term may be extended once. The composition of the Management Board shall be balanced and proportionate and shall reflect the Union as a whole. Mandates shall be overlapping and an appropriate rotating arrangement shall apply. 2. Decisions by the Management Board shall be adopted on the basis of a majority of the members present. Each member shall have one vote. The Executive Director and a representative of the Commission shall participate in meetings of the Management Board without the right to vote. The representative of the Commission shall have the right to vote on matters referred to in Article 63. The Management Board shall adopt and make public its rules of procedure. 3. Meetings of the Management Board shall be convened by the Chairperson at his own initiative or at the request of at least a third of its members, and shall be chaired by the Chairperson. The Management Board shall meet prior to every meeting of the Board of Supervisors and as often as the Management Board deems necessary. It shall meet at least five times a year. 4. The members of the Management Board may, subject to the rules of procedure, be assisted by advisers or experts. The non-voting members, with the exception of the Executive Director, shall not attend any discussions within the Management Board relating to individual financial institutions. Article 46 Independence The members of the Management Board shall act independently and objectively in the sole interest of the Union as a whole and shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State or from any other public or private body. Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the members of the Management Board in the performance of their tasks. Article 47 Tasks 1. The Management Board shall ensure that the Authority carries out its mission and performs the tasks assigned to it in accordance with this Regulation. 2. The Management Board shall propose, for adoption by the Board of Supervisors, an annual and multi-annual work programme. 3. The Management Board shall exercise its budgetary powers in accordance with Articles 63 and 64. 4. The Management Board shall adopt the Authority\u2019s staff policy plan and, pursuant to Article 68(2), the necessary implementing measures of the Staff Regulations of Officials of the European Communities (hereinafter the Staff Regulations\u2019). 5. The Management Board shall adopt the special provisions on right of access to the documents of the Authority, in accordance with Article 72. 6. The Management Board shall propose an annual report on the activities of the Authority, including on the Chairperson\u2019s duties, on the basis of the draft report referred to in Article 53(7) to the Board of Supervisors for approval. 7. The Management Board shall adopt and make public its rules of procedure. 8. The Management Board shall appoint and remove the members of the Board of Appeal in accordance with Article 58(3) and (5). SECTION 3 Chairperson Article 48 Appointment and tasks 1. The Authority shall be represented by a Chairperson, who shall be a full-time independent professional. The Chairperson shall be responsible for preparing the work of the Board of Supervisors and shall chair the meetings of the Board of Supervisors and the Management Board. 2. The Chairperson shall be appointed by the Board of Supervisors on the basis of merit, skills, knowledge of financial institutions and markets, and of experience relevant to financial supervision and regulation, following an open selection procedure. Before taking up his duties, and up to 1 month after the selection by the Board of Supervisors, the European Parliament may, after having heard the candidate selected by the Board of Supervisors, object to the designation of the selected person. The Board of Supervisors shall also elect, from among its members, an alternate who shall carry out the functions of the Chairperson in his absence. That alternate shall not be elected from among the members of the Management Board. 3. The Chairperson\u2019s term of office shall be 5 years and may be extended once. 4. In the course of the 9 months preceding the end of the five-year term of office of the Chairperson, the Board of Supervisors shall evaluate: (a) the results achieved in the first term of office and the way they were achieved; (b) the Authority\u2019s duties and requirements in the coming years. The Board of Supervisors, taking into account the evaluation, may extend the term of office of the Chairperson once subject to confirmation by the European Parliament. 5. The Chairperson may be removed from office only by the European Parliament following a decision of the Board of Supervisors. The Chairperson shall not prevent the Board of Supervisors from discussing matters relating to the Chairperson, in particular the need for his removal, and shall not be involved in deliberations concerning such a matter. Article 49 Independence Without prejudice to the role of the Board of Supervisors in relation to the tasks of the Chairperson, the Chairperson shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State or from any other public or private body. Neither Member States, the Union institutions or bodies nor any other public or private body shall seek to influence the Chairperson in the performance of his tasks. In accordance with the Staff Regulations referred to in Article 68, the Chairperson shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits. Article 50 Report 1. The European Parliament and the Council may invite the Chairperson or his alternate to make a statement, while fully respecting his independence. The Chairperson shall make a statement before the European Parliament and answer any questions put by its members whenever so requested. 2. The Chairperson shall report in writing on the main activities of the Authority to the European Parliament when requested and at least 15 days before making the statement referred to in paragraph 1. 3. In addition to the information referred to in Articles 11 to 18 and Articles 20 and 33, the report shall also include any relevant information requested by the European Parliament on an ad-hoc basis. SECTION 4 Executive Director Article 51 Appointment 1. The Authority shall be managed by an Executive Director, who shall be a full-time independent professional. 2. The Executive Director shall be appointed by the Board of Supervisors, after confirmation by the European Parliament, on the basis of merit, skills, knowledge of financial institutions and markets, and experience relevant to financial supervision and regulation and managerial experience, following an open selection procedure. 3. The Executive Director\u2019s term of office shall be 5 years and may be extended once. 4. In the course of the 9 months preceding the end of the Executive Director\u2019s term of office, the Board of Supervisors shall evaluate in particular: (a) the results achieved in the first term of office and the way they were achieved; (b) the Authority\u2019s duties and requirements in the coming years. The Board of Supervisors, taking into account the evaluation referred to in the first subparagraph, may extend the term of office of the Executive Director once. 5. The Executive Director may be removed from office only upon a decision of the Board of Supervisors. Article 52 Independence Without prejudice to the respective roles of the Management Board and the Board of Supervisors in relation to the tasks of the Executive Director, the Executive Director shall neither seek nor take instructions from the Union institutions or bodies, from any government of a Member State, or from any other public or private body. Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence the Executive Director in the performance of his tasks. In accordance with the Staff Regulations referred to in Article 68, the Executive Director shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits. Article 53 Tasks 1. The Executive Director shall be in charge of the management of the Authority and shall prepare the work of the Management Board. 2. The Executive Director shall be responsible for implementing the annual work programme of the Authority under the guidance of the Board of Supervisors and under the control of the Management Board. 3. The Executive Director shall take the necessary measures, notably the adoption of internal administrative instructions and the publication of notices, to ensure the functioning of the Authority, in accordance with this Regulation. 4. The Executive Director shall prepare a multi-annual work programme, as referred to in Article 47(2). 5. Each year, by 30 June, the Executive Director shall prepare a work programme for the following year, as referred to in Article 47(2). 6. The Executive Director shall draw up a preliminary draft budget of the Authority pursuant to Article 63 and shall implement the budget of the Authority pursuant to Article 64. 7. Each year the Executive Director shall prepare a draft report with a section on the regulatory and supervisory activities of the Authority and a section on financial and administrative matters. 8. The Executive Director shall exercise in respect to the Authority\u2019s staff the powers laid down in Article 68 and manage staff matters. CHAPTER IV JOINT BODIES OF THE EUROPEAN SUPERVISORY AUTHORITIES SECTION 1 Joint Committee of European Supervisory Authorities Article 54 Establishment 1. The Joint Committee of the European Supervisory Authorities is hereby established. 2. The Joint Committee shall serve as a forum in which the Authority shall cooperate regularly and closely and ensure cross-sectoral consistency with the European Supervisory Authority (European Banking Authority) and the European Supervisory Authority (European Securities and Markets Authority), in particular regarding: \u2014 financial conglomerates, \u2014 accounting and auditing, \u2014 micro-prudential analyses of cross-sectoral developments, risks and vulnerabilities for financial stability, \u2014 retail investment products, \u2014 measures combating money laundering; and, \u2014 information exchange with the ESRB and developing the relationship between the ESRB and the ESAs, 3. The Joint Committee shall have a dedicated staff provided by the ESAs that shall act as a secretariat. The Authority shall contribute adequate resources to administrative, infrastructure and operational expenses. 4. In the event that a financial institution reaches across different sectors, the Joint Committee shall resolve disagreements in accordance with Article 56. Article 55 Composition 1. The Joint Committee shall be composed of the Chairpersons of the ESAs, and, where applicable, the Chairperson of any Sub-Committee established under Article 57. 2. The Executive Director, a representative of the Commission and the ESRB shall be invited to the meetings of the Joint Committee, as well as of any Sub-Committees referred to in Article 57, as observers. 3. The Chairperson of the Joint Committee shall be appointed on an annual rotational basis from among the Chairpersons of the ESAs. The Chairperson of the Joint Committee shall be a Vice-Chair of the ESRB. 4. The Joint Committee shall adopt and publish its own rules of procedure. The rules may specify further participants in the meetings of the Joint Committee. The Joint Committee shall meet at least once every 2 months. Article 56 Joint positions and common acts Within the scope of its tasks in Chapter II, and in particular with respect to the implementation of Directive 2002/87/EC, where relevant, the Authority shall reach joint positions with the European Supervisory Authority (European Banking Authority) and with the European Supervisory Authority (European Securities and Markets Authority), as appropriate. Acts under Articles 10 to 15, 17, 18 or 19 of this Regulation in relation to the application of Directive 2002/87/EC and of any other Union acts referred to in Article 1(2) that also fall within the area of competence of the European Supervisory Authority (European Banking Authority) or the European Supervisory Authority (European Securities and Markets Authority) shall be adopted, in parallel, by the Authority, the European Supervisory Authority (European Banking Authority), and the European Supervisory Authority (European Securities and Market Authority), as appropriate. Article 57 Sub-Committees 1. For the purposes of Article 56, a Sub-Committee on Financial Conglomerates to the Joint Committee shall be established. 2. The Sub-Committee shall be composed of the individuals referred to in Article 55(1), and one high-level representative from the current staff of the relevant competent authority from each Member State. 3. The Sub-Committee shall elect a Chairperson from among its members, who shall also be a member of the Joint Committee. 4. The Joint Committee may establish further Sub-Committees. SECTION 2 Board of Appeal Article 58 Composition and operation 1. The Board of Appeal shall be a joint body of the ESAs. 2. The Board of Appeal shall be composed of six members and six alternates, who shall be individuals of a high repute with a proven record of relevant knowledge and professional experience, including supervisory experience, to a sufficiently high level in the fields of banking, insurance, occupational pensions, securities markets or other financial services, excluding current staff of the competent authorities or other national or Union institutions involved in the activities of the Authority. The Board of Appeal shall have sufficient legal expertise to provide expert legal advice on the legality of the Authority\u2019s exercise of its powers. The Board of Appeal shall designate its President. 3. Two members of the Board of Appeal and two alternates shall be appointed by the Management Board of the Authority from a short-list proposed by the Commission, following a public call for expressions of interest published in the Official Journal of the European Union, and after consultation of the Board of Supervisors. The other members shall be appointed in accordance with Regulation (EU) No 1093/2010 and Regulation (EU) No 1095/2010. 4. The term of office of the members of the Board of Appeal shall be 5 years. That term may be extended once. 5. A member of the Board of Appeal appointed by the Management Board of the Authority shall not be removed during his term of office unless he has been found guilty of serious misconduct and the Management Board takes a decision to that effect after consulting the Board of Supervisors. 6. The decisions of the Board of Appeal shall be adopted on the basis of a majority of at least four of its six members. Where the appealed decision falls within the scope of this Regulation, the deciding majority shall include at least one of the two members of the Board of Appeal appointed by the Authority. 7. The Board of Appeal shall be convened by its President when necessary. 8. The ESAs shall ensure adequate operational and secretarial support for the Board of Appeal through the Joint Committee. Article 59 Independence and impartiality 1. The members of the Board of Appeal shall be independent in making their decisions. They shall not be bound by any instructions. They shall not perform any other duties in relation to the Authority, its Management Board or its Board of Supervisors. 2. Members of the Board of Appeal shall not take part in any appeal proceedings in which they have any personal interest if they have previously been involved as representatives of one of the parties to the proceedings, or if they have participated in the decision under appeal. 3. If, for one of the reasons referred to in paragraphs 1 and 2 or for any other reason, a member of a Board of Appeal considers that another member should not take part in any appeal proceedings, he shall inform the Board of Appeal accordingly. 4. Any party to the appeal proceedings may object to the participation of a member of the Board of Appeal on any of the grounds referred to in paragraphs 1 and 2, or if suspected of bias. No objection may be based on the nationality of members nor shall it be admissible if, while being aware of a reason for objecting, the party to the appeal proceedings has nonetheless taken a procedural step other than objecting to the composition of the Board of Appeal. 5. The Board of Appeal shall decide on the action to be taken in the cases specified in paragraphs 1 and 2 without the participation of the member concerned. For the purpose of taking that decision, the member concerned shall be replaced on the Board of Appeal by his alternate. Where the alternate is in a similar situation, the Chairperson shall designate a replacement from among the available alternates. 6. The members of the Board of Appeal shall undertake to act independently and in the public interest. For that purpose, they shall make a declaration of commitments and a declaration of interests indicating either the absence of any interest which may be considered prejudicial to their independence or any direct or indirect interest which might be considered prejudicial to their independence. Those declarations shall be made public, annually and in writing. CHAPTER V REMEDIES Article 60 Appeals 1. Any natural or legal person, including competent authorities, may appeal against a decision of the Authority referred to in Articles 17, 18 and 19and any other decision taken by the Authority in accordance with the Union acts referred to in Article 1(2) which is addressed to that person, or against a decision which, although in the form of a decision addressed to another person, is of direct and individual concern to that person. 2. The appeal, together with a statement of grounds, shall be filed in writing at the Authority within 2 months of the date of notification of the decision to the person concerned, or, in the absence of a notification, of the day on which the Authority published its decision. The Board of Appeal shall decide upon the appeal within 2 months after the appeal has been lodged. 3. An appeal lodged pursuant to paragraph 1 shall not have suspensive effect. However, the Board of Appeal may, if it considers that circumstances so require, suspend the application of the contested decision. 4. If the appeal is admissible, the Board of Appeal shall examine whether it is well-founded. It shall invite the parties to the appeal proceedings to file observations on its own notifications or on communications from the other parties to the appeal proceedings, within specified time limits. Parties to the appeal proceedings shall be entitled to make oral representations. 5. The Board of Appeal may confirm the decision taken by the competent body of the Authority, or remit the case to the competent body of the Authority. That body shall be bound by the decision of the Board of Appeal and that body shall adopt an amended decision regarding the case concerned. 6. The Board of Appeal shall adopt and make public its rules of procedure. 7. The decisions taken by the Board of Appeal shall be reasoned and shall be made public by the Authority. Article 61 Actions before the Court of Justice of the European Union 1. Proceedings may be brought before the Court of Justice of the European Union, in accordance with Article 263 TFEU, contesting a decision taken by the Board of Appeal or, in cases where there is no right of appeal before the Board of Appeal, by the Authority. 2. Member States and the Union institutions, as well as any natural or legal person, may institute proceedings before the Court of Justice of the European Union against decisions of the Authority, in accordance with Article 263 TFEU. 3. In the event that the Authority has an obligation to act and fails to take a decision, proceedings for failure to act may be brought before the Court of Justice of the European Union in accordance with Article 265 TFEU. 4. The Authority shall be required to take the necessary measures to comply with the judgment of the Court of Justice of the European Union. CHAPTER VI FINANCIAL PROVISIONS Article 62 Budget of the Authority 1. The revenues of the Authority, a European body in accordance with Article 185 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (50) (hereinafter the \u2018Financial Regulation\u2019), shall consist, in particular, of any combination of the following: (a) obligatory contributions from the national public authorities competent for the supervision of financial institutions, which shall be made in accordance with a formula based on the weighting of votes set out in Article 3(3) of Protocol (No 36) on transitional provisions. For the purposes of this Article, Article 3(3) of Protocol (No 36) on transitional provisions shall continue to apply beyond the deadline of 31 October 2014 therein established; (b) a subsidy from the Union, entered in the General Budget of the European Union (Commission Section); (c) any fees paid to the Authority in the cases specified in the relevant instruments of Union law. 2. The expenditure of the Authority shall include, at least, staff, remuneration, administrative, infrastructure, professional training and operational expenses. 3. Revenue and expenditure shall be in balance. 4. Estimates of all Authority revenue and expenditure shall be prepared for each financial year, corresponding to the calendar year, and shall be presented in the budget of the Authority. Article 63 Establishment of the budget 1. By 15 February each year, the Executive Director shall draw up a draft statement of estimates of revenue and expenditure for the following financial year, and shall forward it to the Management Board and the Board of Supervisors, together with the establishment plan. Each year, the Board of Supervisors shall, on the basis of the draft statement drawn up by the Executive Director and approved by the Management Board, produce a statement of estimates of revenue and expenditure of the Authority for the following financial year. That statement of estimates, including a draft establishment plan, shall be transmitted by the Board of Supervisors to the Commission by 31 March. Prior to adoption of the statement of estimates, the draft prepared by the Executive Director shall be approved by the Management Board. 2. The statement of estimates shall be transmitted by the Commission to the European Parliament and to the Council (hereinafter referred to together as the \u2018budgetary authority\u2019), together with the draft budget of the European Union. 3. On the basis of the statement of estimates, the Commission shall enter in the draft budget of the European Union the estimates it deems necessary in respect of the establishment plan and the amount of the subsidy to be charged to the General Budget of the European Union in accordance with Articles 313 and 314 TFEU. 4. The budgetary authority shall adopt the establishment plan for the Authority. The budgetary authority shall authorise the appropriations for the subsidy to the Authority. 5. The budget of the Authority shall be adopted by the Board of Supervisors. It shall become final after the final adoption of the General Budget of the European Union. Where necessary, it shall be adjusted accordingly. 6. The Management Board shall, without delay, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any project relating to property, such as the rental or purchase of buildings. It shall inform the Commission thereof. If either branch of the budgetary authority intends to issue an opinion, it shall, within 2 weeks of receipt of the information on the project, notify the Authority of its intention to issue such an opinion. In the absence of a reply, the Authority may proceed with the planned operation. 7. For the first year of operation of the Authority, ending on 31 December 2011, the financing of the Authority by the Union is subject to an agreement by the budgetary authority as provided for in Point 47 of the Interinstitutional Agreement on budgetary discipline and sound financial management. Article 64 Implementation and control of the budget 1. The Executive Director shall act as authorising officer and shall implement the Authority\u2019s budget. 2. By 1 March following the completion of each financial year, the Authority\u2019s accounting officer shall forward to the Commission\u2019s accounting officer and to the Court of Auditors the provisional accounts, accompanied by the report on budgetary and financial management during the financial year. The Authority\u2019s accounting officer shall also send the report on budgetary and financial management to the members of the Board of Supervisors, the European Parliament and the Council by 31 March of the following year. The Commission\u2019s accounting officer shall then consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation. 3. After receiving the observations of the Court of Auditors on the provisional accounts of the Authority in accordance with Article 129 of the Financial Regulation, the Executive Director, acting on his own responsibility, shall draw up the final accounts of the Authority and transmit them, for opinion, to the Management Board. 4. The Management Board shall deliver an opinion on the final accounts of the Authority. 5. The Executive Director shall transmit those final accounts, accompanied by the opinion of the Management Board, by 1 July following the completion of the financial year, to the Members of the Board of Supervisors, the European Parliament, the Council, the Commission and the Court of Auditors. 6. The final accounts shall be published. 7. The Executive Director shall send the Court of Auditors a reply to the latter\u2019s observations by 30 September. He shall also send a copy of that reply to the Management Board and the Commission. 8. The Executive Director shall submit to the European Parliament, at the latter\u2019s request and as provided for in Article 146(3) of the Financial Regulation, any information necessary for the smooth application of the discharge procedure for the financial year in question. 9. The European Parliament, following a recommendation from the Council acting by qualified majority, shall, before 15 May of the year N + 2, grant a discharge to the Authority for the implementation of the budget comprising revenue from the General Budget of the European Union and competent authorities for the financial year N. Article 65 Financial rules The financial rules applicable to the Authority shall be adopted by the Management Board after consulting the Commission. Those rules may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (51) unless the specific operational needs for the functioning of the Authority so require and only with the prior agreement of the Commission. Article 66 Anti-fraud measures 1. For the purposes of combating fraud, corruption and any other illegal activity, Regulation (EC) No 1073/1999 shall apply to the Authority without any restriction. 2. The Authority shall accede to the Interinstitutional Agreement concerning internal investigations by OLAF and shall immediately adopt appropriate provisions for all staff of the Authority. 3. The funding decisions and the agreements and the implementing instruments resulting from them shall explicitly stipulate that the Court of Auditors and OLAF may, if need be, carry out on-the-spot checks on the beneficiaries of monies disbursed by the Authority as well as on the staff responsible for allocating these monies. CHAPTER VII GENERAL PROVISIONS Article 67 Privileges and immunities The Protocol (No 7) on the privileges and immunities of the European Union annexed to the Treaty on European Union and to the TFEU shall apply to the Authority and its staff. Article 68 Staff 1. The Staff Regulations, the Conditions of Employment of Other Servants and the rules adopted jointly by the Union institutions for the purpose of applying them shall apply to the staff of the Authority, including its Executive Director and its Chairperson. 2. The Management Board, in agreement with the Commission, shall adopt the necessary implementing measures, in accordance with the arrangements provided for in Article 110 of the Staff Regulations. 3. In respect of its staff, the Authority shall exercise the powers conferred on the appointing authority by the Staff Regulations and on the authority entitled to conclude contracts by the Conditions of Employment of Other Servants. 4. The Management Board shall adopt provisions to allow national experts from Member States to be seconded to the Authority. Article 69 Liability of the Authority 1. In the case of non-contractual liability, the Authority shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its staff in the performance of their duties. The Court of Justice of the European Union shall have jurisdiction in any dispute over the remedying of such damage. 2. The personal financial liability and disciplinary liability of Authority staff towards the Authority shall be governed by the relevant provisions applying to the staff of the Authority. Article 70 Obligation of professional secrecy 1. Members of the Board of Supervisors and the Management Board, the Executive Director, and members of the staff of the Authority including officials seconded by Member States on a temporary basis and all other persons carrying out tasks for the Authority on a contractual basis shall be subject to the requirements of professional secrecy pursuant to Article 339 TFEU and the relevant provisions in Union legislation, even after their duties have ceased. Article 16 of the Staff Regulations shall apply to them. In accordance with the Staff Regulations, the staff shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits. Neither Member States, the Union institutions or bodies, nor any other public or private body shall seek to influence staff members of the Authority in the performance of their tasks. 2. Without prejudice to cases covered by criminal law, any confidential information received by persons referred to in paragraph 1 whilst performing their duties may not be divulged to any person or authority whatsoever, except in summary or aggregate form, such that individual financial institutions cannot be identified. Moreover, the obligation under paragraph 1 and the first subparagraph of this paragraph shall not prevent the Authority and the national supervisory authorities from using the information for the enforcement of the acts referred to in Article 1(2), and in particular for legal procedures for the adoption of decisions. 3. Paragraphs 1 and 2 shall not prevent the Authority from exchanging information with national supervisory authorities in accordance with this Regulation and other Union legislation applicable to financial institutions. That information shall be subject to the conditions of professional secrecy referred to in paragraphs 1 and 2. The Authority shall lay down in its internal rules of procedure the practical arrangements for implementing the confidentiality rules referred to in paragraphs 1 and 2. 4. The Authority shall apply Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure (52). Article 71 Data protection This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Directive 95/46/EC or the obligations of the Authority relating to its processing of personal data under Regulation (EC) No 45/2001 when fulfilling its responsibilities. Article 72 Access to documents 1. Regulation (EC) No 1049/2001 shall apply to documents held by the Authority. 2. The Management Board shall, by 31 May 2011, adopt practical measures for applying Regulation (EC) No 1049/2001. 3. Decisions taken by the Authority pursuant to Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the Ombudsman or of proceedings before the Court of Justice of the European Union, following an appeal to the Board of Appeal, as appropriate, in accordance with the conditions laid down in Articles 228 and 263 TFEU respectively. Article 73 Language arrangements 1. Council Regulation No 1 determining the languages to be used by the European Economic Community (53) shall apply to the Authority. 2. The Management Board shall decide on the internal language arrangements for the Authority. 3. The translation services required for the functioning of the Authority shall be provided by the Translation Centre for the Bodies of the European Union. Article 74 Headquarters Agreement The necessary arrangements concerning the accommodation to be provided for the Authority in the Member State where its seat is located and the facilities to be made available by that Member State, as well as the specific rules applicable in that Member State to the Executive Director, the members of the Management Board, the staff of the Authority and members of their families shall be laid down in a Headquarters Agreement between the Authority and that Member State concluded after obtaining the approval of the Management Board. That Member State shall provide the best possible conditions to ensure the proper functioning of the Authority, including multilingual, European-oriented schooling and appropriate transport connections. Article 75 Participation of third countries 1. Participation in the work of the Authority shall be open to third countries which have concluded agreements with the Union whereby they have adopted and are applying Union law in the areas of competence of the Authority as referred to in Article 1(2). 2. The Authority may cooperate with the countries referred to in paragraph 1 applying legislation which has been recognised as equivalent in the areas of competence of the Authority referred to in Article 1(2), as provided for in international agreements concluded by the Union in accordance with Article 216 TFEU. 3. Under the relevant provisions of the agreements referred to in paragraphs 1 and 2, arrangements shall be made specifying, in particular, the nature, scope and procedural aspects of the involvement of the countries referred to in paragraph 1 in the work of the Authority, including provisions relating to financial contributions and to staff. They may provide for representation, as an observer, on the Board of Supervisors, but shall ensure that those countries do not attend any discussions relating to individual financial institutions, except where there is a direct interest. CHAPTER VIII TRANSITIONAL AND FINAL PROVISIONS Article 76 Preparatory actions 1. Following the entry into force of this Regulation, and before the establishment of the Authority, CEIOPS shall act in close cooperation with the Commission to prepare for the replacement of CEIOPS by the Authority. 2. Once the Authority has been established, the Commission shall be responsible for the administrative establishment and initial administrative operation of the Authority until the Authority has appointed an Executive Director. For that purpose, until such time as the Executive Director takes up his duties following his appointment by the Board of Supervisors in accordance with Article 51, the Commission may assign one official on an interim basis in order to fulfil the functions of the Executive Director. That period shall be limited to the time necessary for the appointment of an Executive Director of the Authority. The interim Executive Director may authorise all payments covered by credits provided in the budget of the Authority, once approved by the Management Board and may conclude contracts, including staff contracts following the adoption of the Authority\u2019s establishment plan. 3. Paragraphs 1 and 2 are without prejudice to the powers of the Board of Supervisors and the Management Board. 4. The Authority shall be considered the legal successor of CEIOPS. By the date of establishment of the Authority, all assets and liabilities and all pending operations of CEIOPS shall be automatically transferred to the Authority. CEIOPS shall establish a statement showing its closing asset and liability situation as of the date of that transfer. That statement shall be audited and approved by CEIOPS and by the Commission. Article 77 Transitional staff provisions 1. By way of derogation from Article 68, all employment contracts and secondment agreements concluded by CEIOPS or its Secretariat and in force on 1 January 2011 shall be honoured until their expiry date. They may not be extended. 2. All members of staff under contracts referred to in paragraph 1 shall be offered the possibility of concluding temporary agent contracts under Article 2(a) of the Conditions of Employment of Other Servants at the various grades as set out in the Authority\u2019s establishment plan. An internal selection limited to staff who have contracts with CEIOPS or its Secretariat shall be carried out after the entry into force of this Regulation by the authority authorised to conclude contracts in order to check the ability, efficiency and integrity of those to be engaged. The internal selection procedure shall take full account of the skills and experience demonstrated by the individuals\u2019 performance prior to the engagement. 3. Depending on the type and level of functions to be performed, successful applicants shall be offered temporary agents\u2019 contracts of a duration corresponding at least to the time remaining under the prior contract. 4. The relevant national law relating to labour contracts and other relevant instruments shall continue to apply to staff members with prior contracts who choose not to apply for temporary agent\u2019s contracts or who are not offered temporary agents contracts in accordance with paragraph 2. Article 78 National provisions The Member States shall make such provision as is appropriate to ensure the effective application of this Regulation. Article 79 Amendments Decision No 716/2009/EC is hereby amended in so far as CEIOPS is removed from the list of beneficiaries set out in Section B of the Annex to that Decision. Article 80 Repeal Commission Decision 2009/79/EC, establishing CEIOPS, is hereby repealed with effect from 1 January 2011. Article 81 Review 1. By 2 January 2014, and every 3 years thereafter, the Commission shall publish a general report on the experience acquired as a result of the operation of the Authority and the procedures laid down in this Regulation. That report shall evaluate, inter alia: (a) the convergence in supervisory practices reached by competent authorities, (i) the convergence in functional independence of the competent authorities and in standards equivalent to corporate governance; (ii) the impartiality, objectivity and autonomy of the Authority; (b) the functioning of the colleges of supervisors; (c) the progress achieved towards convergence in the fields of crisis prevention, management and resolution, including Union funding mechanisms; (d) the role of the Authority as regards systemic risk; (e) the application of the safeguard clause established in Article 38; (f) the application of the binding mediation role established in Article 19. 2. The report referred to in paragraph 1 shall also examine whether: (a) it is appropriate to continue separate supervision of banking, insurance, occupational pensions, securities and financial markets; (b) it is appropriate to undertake prudential supervision and supervise the conduct of business separately or by the same supervisor; (c) it is appropriate to simplify and reinforce the architecture of the ESFS in order to increase the coherence between the macro and the micro levels and between the ESAs; (d) the evolution of the ESFS is consistent with that of the global evolution; (e) there is sufficient diversity and excellence within the ESFS; (f) accountability and transparency in relation to publication requirements are adequate; (g) the resources of the Authority are adequate to carry out its responsibilities; (h) it is appropriate for the seat of the Authority to be maintained or to move the ESAs to a single seat to enhance better coordination between them. 3. Concerning the issue of direct supervision of institutions or infrastructures of pan-European reach and taking account of market developments, the Commission shall draw up an annual report on the appropriateness of entrusting the Authority with further supervisory responsibilities in this area. 4. The report and any accompanying proposals, as appropriate, shall be forwarded to the European Parliament and to the Council. Article 82 Entry into force This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union. It shall apply from 1 January 2011, with the exception of Article 76 and Article 77(1) and (2), which shall apply as from the date of its entry into force. The Authority shall be established on 1 January 2011. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 24 November 2010. For the Council The President J. BUZEK For the European Parliament The President O. CHASTEL (1) OJ C 13, 20.1.2010, p. 1. (2) Opinion of 22 January 2010 (not yet published in the Official Journal). (3) Position of the European Parliament of 22 September 2010 (not yet published in the Official Journal) and decision of the Council of 17 November 2010. (4) OJ C 40, 7.2.2001, p. 453. (5) OJ C 25 E, 29.1.2004, p. 394. (6) OJ C 175 E, 10.7.2008, p. 392. (7) OJ C 8 E, 14.1.2010, p. 26. (8) OJ C 9 E, 15.1.2010, p. 48. (9) OJ C 184 E, 8.7.2010, p. 214. (10) OJ C 184 E, 8.7.2010, p. 292. (11) See page 1 of this Official Journal. (12) OJ L 25, 29.1.2009, p. 23. (13) OJ L 25, 29.1.2009, p. 28. (14) OJ L 25, 29.1.2009, p. 18. (15) European Court Reports 2006 Page I-03771, para. 44. (16) OJ L 335, 17.12.2009, p. 1. (17) OJ L 9, 15.1.2003, p. 3. (18) OJ L 235, 23.9.2003, p. 10. (19) OJ L 35, 11.2.2003, p. 1. (20) OJ 56, 4.4.1964, p. 878. (21) OJ L 228, 16.8.1973, p. 3. (22) OJ L 228, 16.8.1973, p. 20. (23) OJ L 189, 13.7.1976, p. 13. (24) OJ L 151, 7.6.1978, p. 25. (25) OJ L 339, 27.12.1984, p. 21. (26) OJ L 185, 4.7.1987, p. 77. (27) OJ L 172, 4.7.1988, p. 1. (28) OJ L 228, 11.8.1992, p. 1. (29) OJ L 330, 5.12.1998, p. 1. (30) OJ L 110, 20.4.2001, p. 28. (31) OJ L 345, 19.12.2002, p. 1. (32) OJ L 323, 9.12.2005, p. 1. (33) OJ L 309, 25.11.2005, p. 15. (34) OJ L 271, 9.10.2002, p. 16. (35) OJ L 135, 31.5.1994, p. 5. (36) OJ L 84, 26.3.1997, p. 22. (37) Directive 2007/44/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 92/49/EEC and Directives 2002/83/EC, 2004/39/EC, 2005/68/EC and 2006/48/EC as regards procedural rules and evaluation criteria for the prudential assessment of acquisitions and increase of holdings in the financial sector (OJ L 247, 21.9.2007, p. 1). (38) OJ L 87, 31.3.2009, p. 164. (39) OJ L 318, 27.11.1998, p. 8. (40) OJ C 139, 14.6.2006, p. 1. (41) OJ L 136, 31.5.1999, p. 1. (42) OJ L 136, 31.5.1999, p. 15. (43) OJ L 56, 4.3.1968, p. 1. (44) OJ L 281, 23.11.1995, p. 31. (45) OJ L 8, 12.1.2001, p. 1. (46) OJ L 145, 31.5.2001, p. 43. (47) OJ L 253, 25.9.2009, p. 8. (48) See page 12 of this Official Journal. (49) See page 84 of this Official Journal. (50) OJ L 248, 16.9.2002, p. 1. (51) OJ L 357, 31.12.2002, p. 72. (52) OJ L 317, 3.12.2001, p. 1. (53) OJ 17, 6.10.1958, p. 385.", "summary": "European Insurance and Occupational Pensions Authority (EIOPA) European Insurance and Occupational Pensions Authority (EIOPA) SUMMARY OF: Regulation (EU) No 1094/2010 establishing the European Insurance and Occupational Pensions Authority (EIOPA) WHAT IS THE AIM OF THE REGULATION? It sets up EIOPA, a European Union (EU) body that supports coordination between national authorities and ensures the consistent application of EU laws for the insurance and occupational pensions sectors in EU Member States. Its aim is to promote financial stability and the public\u2019s trust in the insurance and pensions markets. It seeks to protect the rights of policyholders, pension scheme members and beneficiaries. KEY POINTS Consistent application of law EIOPA draws up regulatory and technical standards that accompany laws adopted by the Council and the European Parliament for: insurance and reinsurance companies;financial conglomerates (large financial companies active in various financial sectors);occupational pensions;insurance intermediaries (businesses selling pensions and insurance policies). It also has the power to issue guidelines and recommendations on the application of relevant EU law. Market trends To ensure the stability of insurance markets and to protect policyholders, pension scheme members and beneficiaries, EIOPA carries out a range of tasks. These include monitoring consumer trends and assessing potential market risks and vulnerabilities. Under certain strict conditions, EIOPA can temporarily prohibit or restrict financial activities that cause a threat to the financial system\u2019s stability or have the potential to cause significant financial damage to customers or consumers. Breaches of law EIOPA has the power to investigate a breach of law by a national authority, when a national authority fails to ensure that a financial institution complies with EU law. Within 2 months, EIOPA can issue a recommendation to the national authority. The European Commission may then issue a formal opinion requiring the authority to take the necessary action to comply with the law. If the national authority still does not comply, EIOPA may directly address a decision to a financial institution under certain strict conditions. This decision prevails over previous decisions taken by the national authority on the same matter. Supervisory convergence Amending Regulation (EU) 2019/2175 enhanced the scope of EIOPA\u2019s role and responsibilities. It ensures that EIOPA: is able to assist national supervisors in the use and authorisation of internal models \u2014 used by insurance companies to calculate requirements on solvency capital \u2014 thus helping to achieve more convergent outcomes across the Member States; can promote convergent supervisory practices within the EU\u2019s internal market and assist competent authorities to protect insurance policyholders in cross-border disputes with the introduction of collaboration platforms \u2014 to be set up whenever competent authorities see the need for coordination in the light of specific market developments \u2014 and improved information exchange between the different supervisors of insurance firms operating cross-border; with the other ESAs, assesses the work of the national supervisors (peer reviews) and publishes reports to encourage compliance and increase transparency; in the event of money laundering or terrorist financing by financial sector operators or competent authorities within its remit, gives its prior agreement where a decision is to be taken by the European Banking Authority (which has overarching powers in this field with respect to all the European supervisory authorities). FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) No 1094/2010 has applied since 1 January 2011 (apart from its Article 76 on preparatory actions and Article 77(1) and (2) on transitional staff provisions which apply from 16 December 2010). Amending Regulation (EU) 2019/2175 has applied since 1 January 2020. BACKGROUND For further information, see: About EIOPA (EIOPA). MAIN DOCUMENT Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, pp. 48\u201383). Successive amendments to Regulation (EU) No 1094/2010 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, pp. 349\u2013496). See consolidated version. Council Regulation (EU) No 1096/2010 of 17 November 2010 conferring specific tasks upon the European Central Bank concerning the functioning of the European Systemic Risk Board (OJ L 331,15.12.2010, pp. 162\u2013164). Commission Decision 2004/9/EC of 5 November 2003 establishing the European Insurance and Occupational Pensions Committee (OJ L 3, 7.1.2004, pp. 34\u201335). last update 14.12.2021"}
{"article": "27.5.2011 EN Official Journal of the European Union L 141/1 REGULATION (EU) No 492/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2011 on freedom of movement for workers within the Union (codification) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 46 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Regulation (EEC) No 1612/68 of the Council of 15 October 1968 on freedom of movement for workers within the Community (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Regulation should be codified. (2) Freedom of movement for workers should be secured within the Union. The attainment of this objective entails the abolition of any discrimination based on nationality between workers of the Member States as regards employment, remuneration and other conditions of work and employment, as well as the right of such workers to move freely within the Union in order to pursue activities as employed persons subject to any limitations justified on grounds of public policy, public security or public health. (3) Provisions should be laid down to enable the objectives laid down in Articles 45 and 46 of the Treaty on the Functioning of the European Union in the field of freedom of movement to be achieved. (4) Freedom of movement constitutes a fundamental right of workers and their families. Mobility of labour within the Union must be one of the means by which workers are guaranteed the possibility of improving their living and working conditions and promoting their social advancement, while helping to satisfy the requirements of the economies of the Member States. The right of all workers in the Member States to pursue the activity of their choice within the Union should be affirmed. (5) Such right should be enjoyed without discrimination by permanent, seasonal and frontier workers and by those who pursue their activities for the purpose of providing services. (6) The right of freedom of movement, in order that it may be exercised, by objective standards, in freedom and dignity, requires that equality of treatment be ensured in fact and in law in respect of all matters relating to the actual pursuit of activities as employed persons and to eligibility for housing, and also that obstacles to the mobility of workers be eliminated, in particular as regards the conditions for the integration of the worker\u2019s family into the host country. (7) The principle of non-discrimination between workers in the Union means that all nationals of Member States have the same priority as regards employment as is enjoyed by national workers. (8) The machinery for vacancy clearance, in particular by means of direct cooperation between the central employment services and also between the regional services, as well as by coordination of the exchange of information, ensures in a general way a clearer picture of the labour market. Workers wishing to move should also be regularly informed of living and working conditions. (9) Close links exist between freedom of movement for workers, employment and vocational training, particularly where the latter aims at putting workers in a position to take up concrete offers of employment from other regions of the Union. Such links make it necessary that the problems arising in this connection should no longer be studied in isolation but viewed as interdependent, account also being taken of the problems of employment at the regional level. It is therefore necessary to direct the efforts of Member States toward coordinating their employment policies, HAVE ADOPTED THIS REGULATION: CHAPTER I EMPLOYMENT, EQUAL TREATMENT AND WORKERS\u2019 FAMILIES SECTION 1 Eligibility for employment Article 1 1. Any national of a Member State shall, irrespective of his place of residence, have the right to take up an activity as an employed person, and to pursue such activity, within the territory of another Member State in accordance with the provisions laid down by law, regulation or administrative action governing the employment of nationals of that State. 2. He shall, in particular, have the right to take up available employment in the territory of another Member State with the same priority as nationals of that State. Article 2 Any national of a Member State and any employer pursuing an activity in the territory of a Member State may exchange their applications for and offers of employment, and may conclude and perform contracts of employment in accordance with the provisions in force laid down by law, regulation or administrative action, without any discrimination resulting therefrom. Article 3 1. Under this Regulation, provisions laid down by law, regulation or administrative action or administrative practices of a Member State shall not apply: (a) where they limit application for and offers of employment, or the right of foreign nationals to take up and pursue employment or subject these to conditions not applicable in respect of their own nationals; or (b) where, though applicable irrespective of nationality, their exclusive or principal aim or effect is to keep nationals of other Member States away from the employment offered. The first subparagraph shall not apply to conditions relating to linguistic knowledge required by reason of the nature of the post to be filled. 2. There shall be included in particular among the provisions or practices of a Member State referred to in the first subparagraph of paragraph 1 those which: (a) prescribe a special recruitment procedure for foreign nationals; (b) limit or restrict the advertising of vacancies in the press or through any other medium or subject it to conditions other than those applicable in respect of employers pursuing their activities in the territory of that Member State; (c) subject eligibility for employment to conditions of registration with employment offices or impede recruitment of individual workers, where persons who do not reside in the territory of that State are concerned. Article 4 1. Provisions laid down by law, regulation or administrative action of the Member States which restrict by number or percentage the employment of foreign nationals in any undertaking, branch of activity or region, or at a national level, shall not apply to nationals of the other Member States. 2. When in a Member State the granting of any benefit to undertakings is subject to a minimum percentage of national workers being employed, nationals of the other Member States shall be counted as national workers, subject to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (5). Article 5 A national of a Member State who seeks employment in the territory of another Member State shall receive the same assistance there as that afforded by the employment offices in that State to their own nationals seeking employment. Article 6 1. The engagement and recruitment of a national of one Member State for a post in another Member State shall not depend on medical, vocational or other criteria which are discriminatory on grounds of nationality by comparison with those applied to nationals of the other Member State who wish to pursue the same activity. 2. A national who holds an offer in his name from an employer in a Member State other than that of which he is a national may have to undergo a vocational test, if the employer expressly requests this when making his offer of employment. SECTION 2 Employment and equality of treatment Article 7 1. A worker who is a national of a Member State may not, in the territory of another Member State, be treated differently from national workers by reason of his nationality in respect of any conditions of employment and work, in particular as regards remuneration, dismissal, and, should he become unemployed, reinstatement or re-employment. 2. He shall enjoy the same social and tax advantages as national workers. 3. He shall also, by virtue of the same right and under the same conditions as national workers, have access to training in vocational schools and retraining centres. 4. Any clause of a collective or individual agreement or of any other collective regulation concerning eligibility for employment, remuneration and other conditions of work or dismissal shall be null and void in so far as it lays down or authorises discriminatory conditions in respect of workers who are nationals of the other Member States. Article 8 A worker who is a national of a Member State and who is employed in the territory of another Member State shall enjoy equality of treatment as regards membership of trade unions and the exercise of rights attaching thereto, including the right to vote and to be eligible for the administration or management posts of a trade union. He may be excluded from taking part in the management of bodies governed by public law and from holding an office governed by public law. Furthermore, he shall have the right of eligibility for workers\u2019 representative bodies in the undertaking. The first paragraph of this Article shall not affect laws or regulations in certain Member States which grant more extensive rights to workers coming from the other Member States. Article 9 1. A worker who is a national of a Member State and who is employed in the territory of another Member State shall enjoy all the rights and benefits accorded to national workers in matters of housing, including ownership of the housing he needs. 2. A worker referred to in paragraph 1 may, with the same right as nationals, put his name down on the housing lists in the region in which he is employed, where such lists exist, and shall enjoy the resultant benefits and priorities. If his family has remained in the country whence he came, they shall be considered for this purpose as residing in the said region, where national workers benefit from a similar presumption. SECTION 3 Workers\u2019 families Article 10 The children of a national of a Member State who is or has been employed in the territory of another Member State shall be admitted to that State\u2019s general educational, apprenticeship and vocational training courses under the same conditions as the nationals of that State, if such children are residing in its territory. Member States shall encourage all efforts to enable such children to attend these courses under the best possible conditions. CHAPTER II CLEARANCE OF VACANCIES AND APPLICATIONS FOR EMPLOYMENT SECTION 1 Cooperation between the Member States and with the Commission Article 11 1. The Member States or the Commission shall instigate or together undertake any study of employment or unemployment which they consider necessary for freedom of movement for workers within the Union. The central employment services of the Member States shall cooperate closely with each other and with the Commission with a view to acting jointly as regards the clearing of vacancies and applications for employment within the Union and the resultant placing of workers in employment. 2. To this end the Member States shall designate specialist services which shall be entrusted with organising work in the fields referred to in the second subparagraph of paragraph 1 and cooperating with each other and with the departments of the Commission. The Member States shall notify the Commission of any change in the designation of such services and the Commission shall publish details thereof for information in the Official Journal of the European Union. Article 12 1. The Member States shall send to the Commission information on problems arising in connection with the freedom of movement and employment of workers and particulars of the state and development of employment. 2. The Commission, taking the utmost account of the opinion of the Technical Committee referred to in Article 29 (\u2018the Technical Committee\u2019), shall determine the manner in which the information referred to in paragraph 1 of this Article is to be drawn up. 3. In accordance with the procedure laid down by the Commission taking the utmost account of the opinion of the Technical Committee, the specialist service of each Member State shall send to the specialist services of the other Member States and to the European Coordination Office referred to in Article 18 such information concerning living and working conditions and the state of the labour market as is likely to be of guidance to workers from the other Member States. Such information shall be brought up to date regularly. The specialist services of the other Member States shall ensure that wide publicity is given to such information, in particular by circulating it among the appropriate employment services and by all suitable means of communication for informing the workers concerned. SECTION 2 Machinery for vacancy clearance Article 13 1. The specialist service of each Member State shall regularly send to the specialist services of the other Member States and to the European Coordination Office referred to in Article 18: (a) details of vacancies which could be filled by nationals of other Member States; (b) details of vacancies addressed to third countries; (c) details of applications for employment by those who have formally expressed a wish to work in another Member State; (d) information, by region and by branch of activity, on applicants who have declared themselves actually willing to accept employment in another country. The specialist service of each Member State shall forward this information to the appropriate employment services and agencies as soon as possible. 2. The details of vacancies and applications referred to in paragraph 1 shall be circulated according to a uniform system to be established by the European Coordination Office referred to in Article 18 in collaboration with the Technical Committee. This system may be adapted if necessary. Article 14 1. Any vacancy within the meaning of Article 13 communicated to the employment services of a Member State shall be notified to and processed by the competent employment services of the other Member States concerned. Such services shall forward to the services of the first Member State the details of suitable applications. 2. The applications for employment referred to in point (c) of the first subparagraph of Article 13(1) shall be responded to by the relevant services of the Member States within a reasonable period, not exceeding 1 month. 3. The employment services shall grant workers who are nationals of the Member States the same priority as the relevant measures grant to nationals vis-\u00e0-vis workers from third countries. Article 15 1. The provisions of Article 14 shall be implemented by the specialist services. However, in so far as they have been authorised by the central services and in so far as the organisation of the employment services of a Member State and the placing techniques employed make it possible: (a) the regional employment services of the Member States shall: (i) on the basis of the information referred to in Article 13, on which appropriate action will be taken, directly bring together and clear vacancies and applications for employment; (ii) establish direct relations for clearance: \u2014 of vacancies offered to a named worker, \u2014 of individual applications for employment sent either to a specific employment service or to an employer pursuing his activity within the area covered by such a service, \u2014 where the clearing operations concern seasonal workers who must be recruited as quickly as possible; (b) the services territorially responsible for the border regions of two or more Member States shall regularly exchange data relating to vacancies and applications for employment in their area and, acting in accordance with their arrangements with the other employment services of their countries, shall directly bring together and clear vacancies and applications for employment. If necessary, the services territorially responsible for border regions shall also set up cooperation and service structures to provide: \u2014 users with as much practical information as possible on the various aspects of mobility, and \u2014 management and labour, social services (in particular public, private or those of public interest) and all institutions concerned, with a framework of coordinated measures relating to mobility, (c) official employment services which specialise in certain occupations or specific categories of persons shall cooperate directly with each other. 2. The Member States concerned shall forward to the Commission the list, drawn up by common accord, of services referred to in paragraph 1 and the Commission shall publish such list for information, and any amendment thereto, in the Official Journal of the European Union. Article 16 Adoption of recruiting procedures as applied by the implementing bodies provided for under agreements concluded between two or more Member States shall not be obligatory. SECTION 3 Measures for controlling the balance of the labour market Article 17 1. On the basis of a report from the Commission drawn up from information supplied by the Member States, the latter and the Commission shall at least once a year analyse jointly the results of Union arrangements regarding vacancies and applications. 2. The Member States shall examine with the Commission all the possibilities of giving priority to nationals of Member States when filling employment vacancies in order to achieve a balance between vacancies and applications for employment within the Union. They shall adopt all measures necessary for this purpose. 3. Every 2 years the Commission shall submit a report to the European Parliament, the Council and the European Economic and Social Committee on the implementation of Chapter II, summarising the information required and the data obtained from the studies and research carried out and highlighting any useful points with regard to developments on the Union\u2019s labour market. SECTION 4 European Coordination Office Article 18 The European Office for Coordinating the Clearance of Vacancies and Applications for Employment (\u2018the European Coordination Office\u2019), established within the Commission, shall have the general task of promoting vacancy clearance at Union level. It shall be responsible in particular for all the technical duties in this field which, under the provisions of this Regulation, are assigned to the Commission, and especially for assisting the national employment services. It shall summarise the information referred to in Articles 12 and 13 and the data arising out of the studies and research carried out pursuant to Article 11, so as to bring to light any useful facts about foreseeable developments on the Union labour market; such facts shall be communicated to the specialist services of the Member States and to the Advisory Committee referred to in Article 21 and the Technical Committee. Article 19 1. The European Coordination Office shall be responsible, in particular, for: (a) coordinating the practical measures necessary for vacancy clearance at Union level and for analysing the resulting movements of workers; (b) contributing to such objectives by implementing, in cooperation with the Technical Committee, joint methods of action at administrative and technical levels; (c) carrying out, where a special need arises, and in agreement with the specialist services, the bringing together of vacancies and applications for employment for clearance by those specialist services. 2. It shall communicate to the specialist services vacancies and applications for employment sent directly to the Commission, and shall be informed of the action taken thereon. Article 20 The Commission may, in agreement with the competent authority of each Member State, and in accordance with the conditions and procedures which it shall determine on the basis of the opinion of the Technical Committee, organise visits and assignments for officials of other Member States, and also advanced programmes for specialist personnel. CHAPTER III COMMITTEES FOR ENSURING CLOSE COOPERATION BETWEEN THE MEMBER STATES IN MATTERS CONCERNING THE FREEDOM OF MOVEMENT OF WORKERS AND THEIR EMPLOYMENT SECTION 1 The Advisory Committee Article 21 The Advisory Committee shall be responsible for assisting the Commission in the examination of any questions arising from the application of the Treaty on the Functioning of the European Union and measures taken in pursuance thereof, in matters concerning the freedom of movement of workers and their employment. Article 22 The Advisory Committee shall be responsible in particular for: (a) examining problems concerning freedom of movement and employment within the framework of national manpower policies, with a view to coordinating the employment policies of the Member States at Union level, thus contributing to the development of the economies and to an improved balance of the labour market; (b) making a general study of the effects of implementing this Regulation and any supplementary measures; (c) submitting to the Commission any reasoned proposals for revising this Regulation; (d) delivering, either at the request of the Commission or on its own initiative, reasoned opinions on general questions or on questions of principle, in particular on exchange of information concerning developments in the labour market, on the movement of workers between Member States, on programmes or measures to develop vocational guidance and vocational training which are likely to increase the possibilities of freedom of movement and employment, and on all forms of assistance to workers and their families, including social assistance and the housing of workers. Article 23 1. The Advisory Committee shall be composed of six members for each Member State, two of whom shall represent the Government, two the trade unions and two the employers\u2019 associations. 2. For each of the categories referred to in paragraph 1, one alternate member shall be appointed by each Member State. 3. The term of office of the members and their alternates shall be 2 years. Their appointments shall be renewable. On expiry of their term of office, the members and their alternates shall remain in office until replaced or until their appointments are renewed. Article 24 The members of the Advisory Committee and their alternates shall be appointed by the Council, which shall endeavour, when selecting representatives of trade unions and employers\u2019 associations, to achieve adequate representation on the Committee of the various economic sectors concerned. The list of members and their alternates shall be published by the Council for information in the Official Journal of the European Union. Article 25 The Advisory Committee shall be chaired by a member of the Commission or his representative. The Chairman shall not vote. The Committee shall meet at least twice a year. It shall be convened by its Chairman, either on his own initiative, or at the request of at least one third of the members. Secretarial services shall be provided for the Committee by the Commission. Article 26 The Chairman may invite individuals or representatives of bodies with wide experience in the field of employment or movement of workers to take part in meetings as observers or as experts. The Chairman may be assisted by expert advisers. Article 27 1. An opinion delivered by the Advisory Committee shall not be valid unless two thirds of the members are present. 2. Opinions shall state the reasons on which they are based; they shall be delivered by an absolute majority of the votes validly cast; they shall be accompanied by a written statement of the views expressed by the minority, when the latter so requests. Article 28 The Advisory Committee shall establish its working methods by rules of procedure which shall enter into force after the Council, having received an opinion from the Commission, has given its approval. The entry into force of any amendment that the Committee decides to make thereto shall be subject to the same procedure. SECTION 2 The Technical Committee Article 29 The Technical Committee shall be responsible for assisting the Commission in the preparation, promotion and follow-up of all technical work and measures for giving effect to this Regulation and any supplementary measures. Article 30 The Technical Committee shall be responsible in particular for: (a) promoting and advancing cooperation between the public authorities concerned in the Member States on all technical questions relating to freedom of movement of workers and their employment; (b) formulating procedures for the organisation of the joint activities of the public authorities concerned; (c) facilitating the gathering of information likely to be of use to the Commission and the undertaking of the studies and research provided for in this Regulation, and encouraging exchange of information and experience between the administrative bodies concerned; (d) investigating at a technical level the harmonisation of the criteria by which Member States assess the state of their labour markets. Article 31 1. The Technical Committee shall be composed of representatives of the Governments of the Member States. Each Government shall appoint as member of the Technical Committee one of the members who represent it on the Advisory Committee. 2. Each Government shall appoint an alternate from among its other representatives \u2014 members or alternates \u2014 on the Advisory Committee. Article 32 The Technical Committee shall be chaired by a member of the Commission or his representative. The Chairman shall not vote. The Chairman and the members of the Committee may be assisted by expert advisers. Secretarial services shall be provided for the Committee by the Commission. Article 33 The proposals and opinions formulated by the Technical Committee shall be submitted to the Commission, and the Advisory Committee shall be informed thereof. Any such proposals and opinions shall be accompanied by a written statement of the views expressed by the various members of the Technical Committee, when the latter so request. Article 34 The Technical Committee shall establish its working methods by rules of procedure which shall enter into force after the Council, having received an opinion from the Commission, has given its approval. The entry into force of any amendment which the Committee decides to make thereto shall be subject to the same procedure. CHAPTER IV FINAL PROVISIONS Article 35 The rules of procedure of the Advisory Committee and of the Technical Committee in force on 8 November 1968 shall continue to apply. Article 36 1. This Regulation shall not affect the provisions of the Treaty establishing the European Atomic Energy Community which deal with eligibility for skilled employment in the field of nuclear energy, nor any measures taken in pursuance of that Treaty. Nevertheless, this Regulation shall apply to the category of workers referred to in the first subparagraph and to members of their families in so far as their legal position is not governed by the above-mentioned Treaty or measures. 2. This Regulation shall not affect measures taken in accordance with Article 48 of the Treaty on the Functioning of the European Union. 3. This Regulation shall not affect the obligations of Member States arising out of special relations or future agreements with certain non-European countries or territories, based on institutional ties existing on 8 November 1968, or agreements in existence on 8 November 1968 with certain non-European countries or territories, based on institutional ties between them. Workers from such countries or territories who, in accordance with this provision, are pursuing activities as employed persons in the territory of one of those Member States may not invoke the benefit of the provisions of this Regulation in the territory of the other Member States. Article 37 Member States shall, for information purposes, communicate to the Commission the texts of agreements, conventions or arrangements concluded between them in the manpower field between the date of their being signed and that of their entry into force. Article 38 The Commission shall adopt measures pursuant to this Regulation for its implementation. To this end it shall act in close cooperation with the central public authorities of the Member States. Article 39 The administrative expenditure of the Advisory Committee and of the Technical Committee shall be included in the general budget of the European Union in the section relating to the Commission. Article 40 This Regulation shall apply to the Member States and to their nationals, without prejudice to Articles 2 and 3. Article 41 Regulation (EEC) No 1612/68 is hereby repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 42 This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 5 April 2011. For the European Parliament The President J. BUZEK For the Council The President GY\u0150RI E. (1) OJ C 44, 11.2.2011, p. 170. (2) Position of the European Parliament of 7 September 2010 (not yet published in the Official Journal) and decision of the Council of 21 March 2011. (3) OJ L 257, 19.10.1968, p. 2. (4) See Annex I. (5) OJ L 255, 30.9.2005, p. 22. ANNEX I REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Council Regulation (EEC) No 1612/68 (OJ L 257, 19.10.1968, p. 2) Council Regulation (EEC) No 312/76 (OJ L 39, 14.2.1976, p. 2) Council Regulation (EEC) No 2434/92 (OJ L 245, 26.8.1992, p. 1) Directive 2004/38/EC of the European Parliament and of the Council (OJ L 158, 30.4.2004, p. 77) Only Article 38(1) ANNEX II Correlation Table Regulation (EEC) No 1612/68 This Regulation Part I Chapter I Title I Section 1 Article 1 Article 1 Article 2 Article 2 Article 3(1), first subparagraph Article 3(1), first subparagraph Article 3(1), first subparagraph, first indent Article 3(1), first subparagraph, point (a) Article 3(1), first subparagraph, second indent Article 3(1), first subparagraph, point (b) Article 3(1), second subparagraph Article 3(1), second subparagraph Article 3(2) Article 3(2) Article 4 Article 4 Article 5 Article 5 Article 6 Article 6 Title II Section 2 Article 7 Article 7 Article 8(1) Article 8 Article 9 Article 9 Title III Section 3 Article 12 Article 10 Part II Chapter II Title I Section 1 Article 13 Article 11 Article 14 Article 12 Title II Section 2 Article 15 Article 13 Article 16 Article 14 Article 17 Article 15 Article 18 Article 16 Title III Section 3 Article 19 Article 17 Title IV Section 4 Article 21 Article 18 Article 22 Article 19 Article 23 Article 20 Part III Chapter III Title I Section 1 Article 24 Article 21 Article 25 Article 22 Article 26 Article 23 Article 27 Article 24 Article 28 Article 25 Article 29 Article 26 Article 30 Article 27 Article 31 Article 28 Title II Section 2 Article 32 Article 29 Article 33 Article 30 Article 34 Article 31 Article 35 Article 32 Article 36 Article 33 Article 37 Article 34 Part IV Chapter IV Title I \u2014 Article 38 \u2014 Article 39 Article 35 Article 40 \u2014 Article 41 \u2014 Title II \u2014 Article 42(1) Article 36(1) Article 42(2) Article 36(2) Article 42(3), first subparagraph, first and second indents Article 36(3), first subparagraph Article 42(3), second subparagraph Article 36(3), second subparagraph Article 43 Article 37 Article 44 Article 38 Article 45 \u2014 Article 46 Article 39 Article 47 Article 40 \u2014 Article 41 Article 48 Article 42 \u2014 Annex I \u2014 Annex II", "summary": "Free movement of workers Free movement of workers SUMMARY OF: Regulation (EU) No 492/2011 on the right of EU workers to move within the EU WHAT IS THE AIM OF THE REGULATION? It updates (and codifies) earlier legislation on the ability of European Union citizens to move freely and to work in another EU country. It also seeks to ensure that the principle of free movement enshrined in Article 45 of the Treaty on the Functioning of the European Union (TFEU) is respected in practice. KEY POINTS The free movement of labour benefits the individuals who choose to work elsewhere in the EU as well as the societies which receive them. It enables the former to exercise their right to free movement and to improve their personal and professional situation, and the latter to fill job vacancies and skills shortages. Just as someone living in one EU country has the right to take up gainful employment in another, so can employers advertise job vacancies and agree contracts with potential employees from throughout the EU. The legislation codifies and replaces Regulation (EEC) No 1612/68, which was substantially amended several times. It ensures the system operates smoothly by outlawing any form of nationality discrimination between EU workers. In particular, it bans: separate recruitment procedures for foreign nationals; andlimits on advertising vacancies or the imposition of specific conditions such as registering with employment offices for people coming from another EU country. Similarly, it is illegal to discriminate between national and other EU workers on employment and work terms, covering: access to employment, including the jobseekers\u2019 assistance by employment offices;working conditions, including pay, dismissal, reinstatement or re-employment;access to training, including in vocational schools and retraining centres. The same principle of access to educational, apprenticeship and vocational training schemes applies to the children of someone who is or has been working in another EU country. The legislation covers certain social rights. A worker working in another EU country is entitled to the same social and tax advantages as nationals of the host EU country. He also has the right to housing benefits in the same conditions as nationals and may register on a housing list, where these exist, in the area where they are working. The legislation also covers equality of treatment as regards membership of trade unions and the exercise of related rights, such as the right to vote and to be eligible for administrative or management posts in a trade union. A certain level of language knowledge may be required for a job, but any language requirement must be reasonable and necessary for the job in question. The legislation sets up an Advisory Committee comprising 6 members from each EU country: 2 representing the government, 2 the trade unions and 2 the employers\u2019 associations. This committee assists the European Commission in matters concerning free movement of workers. The European Labour Authority, established by Regulation (EU) 2019/1149 participates in the committee\u2019s meetings as an observer, providing technical input and expertise. One exceptionThe one exception to the non-discrimination principle concerns access to posts involving the exercise of public authority and duties designed to safeguard the general interests of the state. EU countries may reserve such posts for their own nationals. EURES regulation In 2016, Regulation (EU) No 492/2011 was amended by Regulation (EU) 2016/589 on the European Employment Services (EURES). As a result, the rules on the exchange of information on job vacancies, job applications and CVs across EU countries now fall within the scope of the new regulation. FROM WHEN DOES THE REGULATION APPLY? It has applied since 16 June 2011. Regulation (EU) No 492/2011 codified and replaced Regulation (EEC) No 1612/68 and its subsequent amendments. BACKGROUND For more information, see: Free movement \u2014 EU nationals (European Commission). Communication from the Commission \u2014 Guidelines concerning the exercise of the free movement of workers during COVID-19 outbreak MAIN DOCUMENT Regulation (EU) No 492/2011 of the European Parliament and of the Council of 5 April 2011 on freedom of movement for workers within the Union (codification) (OJ L 141, 27.5.2011, pp. 1-12) Successive amendments to Regulation (EU) No 492/2011 have been incorporated in to the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2019/1149 of the European Parliament and of the Council of 20 June 2019 establishing a European Labour Authority, amending Regulations (EC) No 883/2004, (EU) No 492/2011, and (EU) 2016/589 and repealing Decision (EU) 2016/344 (OJ L 186, 11.7.2019, pp. 21-56) Special Report No 6/2018 \u2014 \u2018Free Movement of Workers \u2014 the fundamental freedom ensured but better targeting of EU funds would aid worker mobility\u2019 (OJ C 79, 2.3.2018, p. 17) Directive 2014/54/EU of the European Parliament and of the Council of 16 April 2014 on measures facilitating the exercise of rights conferred on workers in the context of freedom of movement for workers (OJ L 128, 30.4.2014, pp. 8-14) Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Three: Union policies and internal actions \u2014 Title IV: Free movement of persons, services and capital \u2014 Chapter 1: Workers \u2014 Article 45 (ex Article 39 TEC) (OJ C 202, 7.6.2016, pp. 65-66) last update 21.04.2020"}
{"article": "31.10.2009 EN Official Journal of the European Union L 286/1 REGULATION (EC) No 1005/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 September 2009 on substances that deplete the ozone layer (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer (3) has been substantially amended several times. Since further amendments are to be made, it should be recast in the interests of clarity. (2) It is established that continued emissions of ozone-depleting substances (ODS) cause significant damage to the ozone layer. There is clear evidence of a decrease in the atmospheric burden of ODS and some early signs of stratospheric ozone recovery have been observed. However, the recovery of the ozone layer to the concentrations level existing before 1980 is not projected to take place before the middle of the 21st century. Increased UV-B radiation resulting from ozone depletion therefore persists as a significant threat to health and environment. At the same time, most of these substances have high global warming potential and are contributory factors towards increasing the temperature of the planet. Further efficient measures need therefore to be taken in order to protect human health and the environment against adverse effects resulting from such emissions and to avoid risking further delay in the recovery of the ozone layer. (3) In view of its responsibilities for the environment and trade, the Community, pursuant to Council Decision 88/540/EEC (4), has become a Party to the Vienna Convention for the Protection of the Ozone Layer and the Montreal Protocol on Substances that Deplete the Ozone Layer (hereinafter \u2018the Protocol\u2019). (4) Many ODS are greenhouse gases but are not controlled under the United Nations Framework Convention for Climate Change and its Kyoto Protocol on the assumption that the Protocol will phase out ODS. Despite progress made by the Protocol, the task of phasing out ODS still needs to be completed in the European Union and globally, whilst bearing in mind that at present many alternatives to ODS have a high global warming potential. It is therefore necessary to minimise and eliminate the production and use of ODS wherever technically feasible alternatives with low global warming potential are available. (5) Additional measures for the protection of the ozone layer were adopted by the Parties to the Protocol, most recently at their meeting in Montreal in September 2007 and in Doha in November 2008. It is necessary for action to be taken at Community level to comply with the Community\u2019s obligations under the Protocol and in particular to implement the accelerated phase out of hydrochlorofluorocarbons with due consideration to the risks of phasing in alternatives with high global warming potential. (6) Following the concerns stated in the 2006 Report of the Scientific Assessment Panel related to the accelerating growth of production and consumption of hydrochlorofluorocarbons in developing countries, the Parties to the Protocol in 2007 adopted Decision XIX/6 at their 19th Meeting providing for an accelerated phase-out schedule for hydrochlorofluorocarbons. Following that Decision the production phase-out date should be brought forward from 2025 to 2020. (7) Under Regulation (EC) No 2037/2000, as from 2010, virgin hydrochlorofluorocarbons can no longer be used for the maintenance or servicing of refrigeration and air conditioning equipment. In order to minimise the risk of illegal use of virgin hydrochlorofluorocarbons as recycled or reclaimed material, only reclaimed or recycled material should be used in maintenance or servicing operations. The re-selling of recycled hydrochlorofluorocarbons should be prohibited, and recycled hydrochlorofluorocarbons should only be used when recovered from such equipment and only by the undertaking which carried out or mandated the recovery. For consistency this exemption should also apply to heat pump equipment. (8) In view of the wide availability of technologies and alternative substances for replacing ODS, it is appropriate in certain cases to provide for control measures which are stricter than those provided for in Regulation (EC) No 2037/2000 and stricter than those in the Protocol. (9) Under Regulation (EC) No 2037/2000 the production and placing on the market of chlorofluorocarbons, other fully halogenated chlorofluorocarbons, halons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons, bromochloromethane and methyl bromide have been phased out and the placing on the market of those substances and of products and equipment containing those substances is thus prohibited. It is now also appropriate to progressively generalise the ban on the use of those substances for the maintenance or servicing of such equipment. (10) Even after the phase out of controlled substances the Commission should, under certain conditions, grant exemptions for essential laboratory and analytical uses. In particular, Decision X/14 of the Parties to the Protocol establishes criteria for granting of exemptions for those uses. The Commission should be empowered to establish conditions for essential laboratory and analytical uses. To avoid an increase in the quantities used for these purposes, producers and importers should not be allowed to significantly increase the quantities placed on the market. Specific conditions decided by the Parties for the placing on the market of substances for those uses should be integrated into this Regulation to ensure compliance with them. (11) The availability of alternatives to methyl bromide has been reflected in more substantial reductions in its production and consumption compared to the Protocol, as well as in Commission Decision 2008/753/EC of 18 September 2008 concerning the non-inclusion of methyl bromide in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (5) and in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (6). The exemption for critical uses of methyl bromide should cease completely whilst temporarily allowing the possibility to grant a derogation in emergency situations in the case of unexpected pests or disease outbreaks where such emergency use is to be permitted under Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (7) and Directive 98/8/EC. In such cases measures to minimise emissions, such as the use of virtually impermeable films for soil fumigation, should be specified. (12) In view of Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (8), which banned the use of methyl bromide as a biocide by 1 September 2006, and Decision 2008/753/EC, which banned the use of methyl bromide as a plant protection product by 18 March 2010, the use of methyl bromide for quarantine and pre-shipment applications should also be banned by 18 March 2010. (13) The Protocol, in Article 2F(7), requires the Parties to endeavour to ensure that the use of hydrochlorofluorocarbons is limited to those applications where more environmentally suitable alternative substances or technologies are not available. In view of the availability of alternative and substitute technologies, the placing on the market and use of hydrochlorofluorocarbons as well as of products and equipment containing or relying on hydrochlorofluorocarbons can be further limited. Decision VI/13 of the Parties to the Protocol provides that the evaluation of alternatives to hydrochlorofluorocarbons should take into account such factors as ozone-depleting potential, energy efficiency, potential flammability, toxicity, global warming potential and the potential impacts on the effective use and phase out of chlorofluorocarbons and halons. The Parties concluded in that decision that hydrochlorofluorocarbon controls under the Protocol should be considerably tightened to protect the ozone layer and to reflect the availability of alternatives. (14) Control measures regarding products and equipment containing controlled substances should be extended to products and equipment relying on those substances in order to prevent circumventions of the restrictions under this Regulation. By covering additionally products and equipment for which the design, the use or the proper functioning requires the presence of a controlled substance, a potential opportunity to place on the market, import or export products or equipment which do not contain controlled substances at that moment, but which would have to be refilled at a later date, is eliminated. Furthermore, exemptions for products and equipment manufactured before the entry into force of the control measures should be removed as they are no longer relevant and might constitute a risk of illegal placing on the market or trade. (15) Controlled substances as well as products and equipment containing or relying on controlled substances from States not party to the Protocol should not be imported. Furthermore, the export of products and equipment containing or relying on hydrochlorofluorocarbons after the entry into force of a ban on use of those products and equipment or of controlled substances for their maintenance or servicing in the Community should be prohibited in order to avoid the building-up of banks of those substances in countries where sufficient destruction facilities are not available. (16) The licensing system for controlled substances includes the authorisation of exports of controlled substances, in order to improve the monitoring of and control of trade in ODS and to allow for exchange of information between Parties. That licensing system should be extended to products and equipment containing or relying on controlled substances. (17) To improve the monitoring and control of trade the licensing should cover not only the entry of goods into the customs territory for release for free circulation in the Community but also the entry under other customs procedures or for customs-approved treatments and uses. Transit through the customs territory of the Community, temporary storage, customs warehousing and the free zone procedure should still be possible without licensing in order to avoid unnecessary burdens on operators and customs authorities. Shipments to or from a territory of a Member State that is not part of the customs territory of the Community or not covered by this Regulation, but which is covered by the Member State\u2019s ratification of the Protocol should not create unnecessary burdens to Member States in relation to licensing and reporting provided that the obligations of this Regulation and the Protocol are complied with. (18) Before issuing import and export licences the Commission should be enabled to verify with the competent authorities of the third country concerned whether the intended transaction would comply with the requirements applicable in that country, in order to avoid illegal and unwanted trade. (19) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (9), Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (10) and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (11) provide for the labelling of substances classified as ODS and the labelling of mixtures containing such substances. As ODS produced for feedstock, process agent, laboratory and analytical uses can be released for free circulation in the Community, they should be distinguished from those substances produced for other uses, in order to avoid any diversions of controlled substances intended for feedstock, as a process agent or for laboratory and analytical uses to other uses which are controlled under this Regulation. Furthermore, in order to inform end users and to facilitate the enforcement of this Regulation also products and equipment containing or relying on such substances should be so labelled during maintenance or servicing. (20) To reduce the release of controlled substances into the atmosphere, provision should be made for the recovery of used controlled substances and the prevention of leakages of controlled substances. (21) The Protocol requires reporting on trade in ODS. Annual reporting should therefore be required from producers, importers and exporters of controlled substances. In order to enable the Commission to streamline the reporting procedures to comply with the Protocol and avoid duplications in the process, destruction facilities should also report directly to the Commission. To ensure compliance with reporting obligations under the Protocol and to improve their practical application the Commission should be empowered to modify the reporting requirements for Member States and undertakings. In view of the envisaged development of Internet-based reporting tools the Commission should, as appropriate, draft measures to adapt the reporting requirements as soon as the relevant reporting tools are in place. (22) The protection of individuals with regard to the processing of personal data by the Member States is governed by Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (12) and the protection of individuals with regard to the processing of personal data by the Commission is governed by Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (13) in particular as regards the requirements of confidentiality and security of processing, the transfer of personal data from the Commission to the Member States, the lawfulness of processing, and the rights of data subjects to information, access to and rectification of their personal data. (23) Member States should carry out inspections, taking a risk-based approach in order to ensure compliance with all provisions of this Regulation and thus targeting those activities representing the highest risk of illegal trade or emission of controlled substances. Recommendation 2001/331/EC of the European Parliament and of the Council of 4 April 2001 providing for minimum criteria for environmental inspections in the Member States (14) should provide guidance for the carrying out of inspections by Member States. (24) In view of the continuing innovation in the sectors covered by this Regulation, the Commission should regularly review this Regulation and, if appropriate, make proposals, in particular on the exemptions and derogations provided for when technically and economically feasible alternatives to the use of controlled substances become available, to further strengthen the protection of the ozone layer and simultaneously reduce greenhouse gases emissions. In order to ensure compliance with the Protocol, the Commission should be empowered to align Annexes to this Regulation with decisions of the Parties, in particular with those concerning approved destruction methods, conditions for the placing on the market of controlled substances for essential laboratory and analytical uses, and processes in which controlled substances may be used as process agents. (25) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (15). (26) In particular, the Commission should be empowered to determine the form and content of labels for controlled substances produced, placed on the market or used as feedstock, as process agent or for laboratory and analytical uses; to amend Annex III on processes for which controlled substances may be used as process agents; to amend the maximum amount of controlled substances that may be used as process agents or emitted from process agents uses; to amend Annex V on conditions for placing on the market and further distribution of controlled substances for laboratory and analytical uses; to determine a mechanism for the allocation of quotas for controlled substances for laboratory and analytical uses; to amend Annex VI; to adopt modifications and time frames for the phasing out of the critical uses of halons; to amend the list of items required to be stated in an application for a licence; to adopt additional monitoring measures on trade in controlled substances or new substances and of products and equipment containing or relying on controlled substances; to adopt rules applicable to the release for free circulation in the Community of products and equipment imported from any State not party to the Protocol which were produced using controlled substances; to amend Annex VII on destruction technologies; to establish a list with products and equipment for which the recovery for destruction or destruction without prior recovery of controlled substances should be considered technically and economically feasible and therefore mandatory; to adopt minimum qualification requirements for personnel; to establish a list of technologies and practices to be used by undertakings to prevent and minimise any leakage and emission of controlled substances; to include new substances in Annex II and to amend reporting requirements for Member States and undertakings. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (27) Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste (16) and Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (17) provide for measures on the environmentally sound disposal and recovery of waste and controls on hazardous waste. In this regard, special attention should be paid to ODS in construction and demolition waste and in equipment falling within the scope of Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE) (18). In accordance with the Protocol only technologies approved by the Parties may be applied to the destruction of controlled substances. The relevant decisions of the Parties should therefore be incorporated in this Regulation to ensure that only those technologies are applied, provided that their application is compatible with Community and national legislation on waste. (28) A flexible mechanism should be established to introduce reporting obligations for substances identified as ozone depleting, to allow for assessing the magnitude of their environmental impact and to ensure that those new substances which have been identified as having a significant ozone-depleting potential are subject to control measures. In this context, special attention should be paid to the role of very short-lived substances, having regard, in particular, to the 2006 United Nations Environment Programme/World Meteorological Organisation (UNEP/WMO) ozone assessment, which concluded that the ozone-depleting potential of those substances is greater than previously assessed. (29) Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive. (30) Since the objectives of this Regulation, namely to ensure compliance with the Community\u2019s obligations as party to the Protocol and to address a transboundary environmental problem with global impact whilst regulating intra-Community and external trade in ODS and products and equipment containing or relying on those substances, cannot be sufficiently achieved by the Member States acting individually and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down rules on the production, import, export, placing on the market, use, recovery, recycling, reclamation and destruction of substances that deplete the ozone layer, on the reporting of information related to those substances and on the import, export, placing on the market and use of products and equipment containing or relying on those substances. Article 2 Scope This Regulation shall apply to controlled substances, to new substances and to products and equipment containing or relying on controlled substances. Article 3 Definitions For the purposes of this Regulation: 1. \u2018Protocol\u2019 means the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer, as last amended and adjusted; 2. \u2018Party\u2019 means any party to the Protocol; 3. \u2018State not party to the Protocol\u2019 means, with respect to a particular controlled substance, any State or regional economic integration organisation that has not agreed to be bound by the provisions of the Protocol applicable to that substance; 4. \u2018controlled substances\u2019 means substances listed in Annex I, including their isomers, whether alone or in a mixture, and whether they are virgin, recovered, recycled or reclaimed; 5. \u2018chlorofluorocarbons\u2019 means the controlled substances listed in Group I of Annex I, including their isomers; 6. \u2018halons\u2019 means the controlled substances listed in Group III of Annex I, including their isomers; 7. \u2018carbon tetrachloride\u2019 means the controlled substance specified in Group IV of Annex I; 8. \u2018methyl bromide\u2019 means the controlled substance specified in Group VI of Annex I; 9. \u2018hydrochlorofluorocarbons\u2019 means the controlled substances listed in Group VIII of Annex I, including their isomers; 10. \u2018new substances\u2019 means substances listed in Annex II, whether alone or in a mixture, and whether they are virgin, recovered, recycled or reclaimed; 11. \u2018feedstock\u2019 means any controlled substance or new substance that undergoes chemical transformation in a process in which it is entirely converted from its original composition and whose emissions are insignificant; 12. \u2018process agents\u2019 means controlled substances used as chemical process agents in the applications listed in Annex III; 13. \u2018producer\u2019 means any natural or legal person producing controlled substances or new substances within the Community; 14. \u2018production\u2019 means the amount of controlled substances or new substances produced, including the amount produced, intentionally or inadvertently, as a by-product unless that by-product is destroyed as part of the manufacturing process or following a documented procedure ensuring compliance with this Regulation and the Community and national legislation on waste. No amount recovered, recycled or reclaimed shall be considered as \u2018production\u2019, nor shall any insignificant amount unavoidably incorporated in products in trace quantities or emitted during manufacturing; 15. \u2018ozone-depleting potential\u2019 or \u2018ODP\u2019 means the figure specified in Annexes I and II representing the potential effect of each controlled substance or new substance on the ozone layer; 16. \u2018calculated level\u2019 means a quantity determined by multiplying the quantity of each controlled substance by its ozone-depleting potential and by adding together, for each group of controlled substances in Annex I separately, the resulting figures; 17. \u2018industrial rationalisation\u2019 means the transfer either between Parties or within a Member State of all or a portion of the calculated level of production of one producer to another, for the purpose of optimising economic efficiency or responding to anticipated shortfalls in supply as a result of plant closures; 18. \u2018import\u2019 means the entry of substances, products and equipment covered by this Regulation into the customs territory of the Community as far as the territory is covered by a Member State\u2019s ratification of the Protocol and this Regulation applies; 19. \u2018export\u2019 means the exit from the customs territory of the Community, in so far as the territory is covered by a Member State\u2019s ratification of the Protocol and by this Regulation, of substances, products and equipment covered by this Regulation which have the status of Community goods or the re-export of substances, products and equipment covered by this Regulation if they have the status of non-Community goods; 20. \u2018placing on the market\u2019 means the supplying or making available to third persons within the Community for payment or free of charge, and includes the release for free circulation in the Community as referred to in Regulation (EC) No 450/2008. In respect of products and equipment being part of immovable property or part of means of transport this refers only to the supplying or making available within the Community for the first time; 21. \u2018use\u2019 means the utilisation of controlled substances or new substances in the production, maintenance or servicing, including refilling, of products and equipment or in other processes; 22. \u2018heat pump\u2019 means a device or installation that extracts heat at low temperatures from air, water or earth and supplies heat; 23. \u2018recovery\u2019 means the collection and the storage of controlled substances from products and equipment or containers during maintenance or servicing or before disposal; 24. \u2018recycling\u2019 means the reuse of a recovered controlled substance following a basic cleaning process; 25. \u2018reclamation\u2019 means the reprocessing of a recovered controlled substance in order to meet the equivalent performance of a virgin substance, taking into account its intended use; 26. \u2018undertaking\u2019 means any natural or legal person which: (a) produces, recovers, recycles, reclaims, uses or destroys controlled substances or new substances; (b) imports such substances; (c) exports such substances; (d) places such substances on the market; or (e) operates refrigeration, air conditioning or heat pump equipment, or fire protection systems, which contain controlled substances; 27. \u2018quarantine applications\u2019 means treatments to prevent the introduction, establishment or spread of quarantine pests (including diseases), or to ensure their official control, where: \u2014 official control is that performed by, or authorised by, a national plant, animal or environmental protection or health authority, \u2014 quarantine pests are pests of potential importance to the areas endangered thereby and not yet present there, or present but not widely distributed, and being officially controlled; 28. \u2018pre-shipment applications\u2019 means those non-quarantine applications applied no more than 21 days prior to export to meet the official requirements of the importing country or official requirements of the exporting country existing before 7 December 1995. Official requirements are those which are performed by, or authorised by, a national plant, animal, environmental, health or stored product authority; 29. \u2018products and equipment relying on controlled substances\u2019 means products and equipment which do not function without controlled substances, not including those products and equipment used for the production, processing, recovery, recycling, reclamation or destruction of controlled substances; 30. \u2018virgin substances\u2019 means substances which have not previously been used; 31. \u2018products and equipment\u2019 means all products and equipment except containers used for the transportation or storage of controlled substances. CHAPTER II PROHIBITIONS Article 4 Production of controlled substances The production of controlled substances shall be prohibited. Article 5 Placing on the market and use of controlled substances 1. The placing on the market and the use of controlled substances shall be prohibited. 2. Controlled substances shall not be placed on the market in non-refillable containers, except for laboratory and analytical uses as referred to in Article 10 and Article 11(2). 3. This Article shall not apply to controlled substances in products and equipment. Article 6 Placing on the market of products and equipment containing or relying on controlled substances 1. The placing on the market of products and equipment containing or relying on controlled substances shall be prohibited, with the exception of products and equipment for which the use of the respective controlled substance is authorised in accordance with Article 10, Article 11(2) or Article 13 or has been authorised on the basis of Article 3(1) of Regulation (EC) No 2037/2000. 2. Except for uses referred to in Article 13(1), fire protection systems and fire extinguishers containing halons shall be prohibited and shall be decommissioned. CHAPTER III EXEMPTIONS AND DEROGATIONS Article 7 Production, placing on the market and use of controlled substances as feedstock 1. By way of derogation from Articles 4 and 5, controlled substances may be produced, placed on the market and used as feedstock. 2. Controlled substances produced or placed on the market as feedstock may only be used for that purpose. As of 1 July 2010, containers of such substances shall be labelled with a clear indication that the substance may only be used as feedstock. Where such substances are required to be labelled in accordance with Directive 67/548/EEC, Directive 1999/45/EC or Regulation (EC) No 1272/2008, such indication shall be included in the label referred to in those Directives or in the supplemental information part of the label as referred to in Article 25(3) of that Regulation. The Commission may determine the form and content of the label to be used. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 8 Production, placing on the market and use of controlled substances as process agents 1. By way of derogation from Articles 4 and 5, controlled substances may be produced, placed on the market and used as process agents. 2. Controlled substances may only be used as process agents in installations existing on 1 September 1997, and where emissions are insignificant. 3. Controlled substances produced or placed on the market as process agents may only be used for that purpose. As of 1 July 2010, containers of such substances shall be labelled with a clear indication that those substances may only be used as process agents. Where such substances are required to be labelled in accordance with Directive 67/548/EEC, Directive 1999/45/EC or Regulation (EC) No 1272/2008, such indication shall be included in the label referred to in those Directives or in the supplemental information part of the label as referred to in Article 25(3) of that Regulation. The Commission may determine the form and content of the label to be used. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 4. The Commission shall, if appropriate, in accordance with the management procedure referred to in Article 25(2), establish a list of undertakings in which the use of controlled substances as process agents shall be permitted, laying down maximum quantities that may be used for make-up or for consumption as process agents and emission levels for each of the undertakings concerned. The maximum amount of controlled substances that may be used as process agents within the Community shall not exceed 1 083 metric tonnes per year. The maximum amount of controlled substances that may be emitted from process agent uses within the Community shall not exceed 17 metric tonnes per year. 5. In the light of new information or technical developments or decisions taken by the Parties, the Commission shall, if appropriate: (a) amend Annex III; (b) amend the maximum amount of controlled substances that may be used as process agents or emitted from process agent uses as referred to in the second and third subparagraphs of paragraph 4. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 9 Placing on the market of controlled substances for destruction or reclamation and of products and equipment containing or relying on controlled substances for destruction By way of derogation from Articles 5 and 6, controlled substances and products and equipment containing or relying on controlled substances may be placed on the market for destruction within the Community in accordance with the requirements for destruction referred to in Article 22(1). Controlled substances may also be placed on the market for reclamation within the Community. Article 10 Essential laboratory and analytical uses of controlled substances other than hydrochlorofluorocarbons 1. By way of derogation from Articles 4 and 5, controlled substances other than hydrochlorofluorocarbons may be produced, placed on the market and used for essential laboratory and analytical uses, subject to registration and licensing in accordance with this Article. 2. The Commission shall, if appropriate, in accordance with the management procedure referred to in Article 25(2), determine any essential laboratory and analytical uses for which the production and import of controlled substances other than hydrochlorofluorocarbons may be permitted in the Community, the respective quantities, the period for which the exemption shall be valid and those users which may take advantage of those essential laboratory and analytical uses. 3. Controlled substances produced or placed on the market for essential laboratory and analytical uses may only be used for that purpose. As of 1 July 2010, containers containing such substances shall be labelled with a clear indication that the substance may only be used for laboratory and analytical uses. Where such substances are required to be labelled in accordance with Directive 67/548/EEC, Directive 1999/45/EC or Regulation (EC) No 1272/2008, such indication shall be included in the label referred to in those Directives or in the supplemental information part of the label as referred to in Article 25(3) of that Regulation. The Commission may determine the form and content of the label to be used. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Controlled substances referred to in the first subparagraph shall only be placed on the market and further distributed under the conditions set out in Annex V. The Commission may amend that Annex. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 4. Any undertaking using controlled substances other than hydrochlorofluorocarbons for essential laboratory and analytical uses shall register with the Commission, indicating the substances being used, the purpose, the estimated annual consumption and the suppliers of those substances, and shall update that information when changes occur. 5. By the date specified in a notice issued by the Commission, producers and importers supplying the undertaking referred to in paragraph 4 or using controlled substances for their own account shall declare to the Commission the foreseen demand for the period specified in the notice, specifying the nature and quantities of controlled substances needed. 6. The Commission shall issue licences to producers and importers of controlled substances, other than hydrochlorofluorocarbons, produced or imported for essential laboratory and analytical uses and shall notify them of the use for which they have authorisation and the substances and quantities thereof that they are authorised to place on the market or to use for their own account. The quantity annually authorised under licences for individual producers and importers shall not exceed 130 % of the annual average of the calculated level of controlled substances licensed for the producer or importer for essential laboratory and analytical uses in the years 2007 to 2009. The total quantity annually authorised under licences, including licences for hydrochlorofluorocarbons under Article 11(2), shall not exceed 110 ODP tonnes. Remaining quantities may be allocated to producers and importers which did not place on the market or use controlled substances, for their own account for essential laboratory and analytical uses in the years 2007 to 2009. The Commission shall determine a mechanism for the allocation of quotas to producers and importers. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 7. A producer may be authorised by the competent authority of the Member State in which that producer\u2019s relevant production is situated to produce the controlled substances referred to in paragraph 1 for the purpose of meeting the requests licensed in accordance with paragraph 6. The competent authority of the Member State concerned shall notify the Commission in advance of its intention to issue any such authorisation. 8. To the extent permitted by the Protocol, the competent authority of the Member State in which a producer\u2019s relevant production is situated may authorise that producer to produce or to exceed the calculated levels of production laid down in paragraph 6 in order to satisfy any essential laboratory and analytical uses of Parties at their request. The competent authority of the Member State concerned shall notify the Commission in advance of its intention to issue any such authorisation. Article 11 Production, placing on the market and use of hydrochlorofluorocarbons and placing on the market of products and equipment containing or relying on hydrochlorofluorocarbons 1. By way of derogation from Article 4, hydrochlorofluorocarbons may be produced provided that each producer ensures the following: (a) the calculated level of its production of hydrochlorofluorocarbons in the period from 1 January 2010 to 31 December 2010 and in each 12-month period thereafter until 31 December 2013 does not exceed 35 % of the calculated level of its production of hydrochlorofluorocarbons in 1997; (b) the calculated level of its production of hydrochlorofluorocarbons in the period from 1 January 2014 to 31 December 2014 and in each 12-month period thereafter until 31 December 2016 does not exceed 14 % of the calculated level of its production of hydrochlorofluorocarbons in 1997; (c) the calculated level of its production of hydrochlorofluorocarbons in the period from 1 January 2017 to 31 December 2017 and in each 12-month period thereafter until 31 December 2019 does not exceed 7 % of the calculated level of its production of hydrochlorofluorocarbons in 1997; (d) it produces no hydrochlorofluorocarbons after 31 December 2019. 2. By way of derogation from Article 4 and Article 5(1), hydrochlorofluorocarbons may be produced, placed on the market and used for laboratory and analytical uses. Article 10(3) to (7) shall apply mutatis mutandis. 3. By way of derogation from Article 5, until 31 December 2014, reclaimed hydrochlorofluorocarbons may be placed on the market and used for the maintenance or servicing of existing refrigeration, air-conditioning and heat pump equipment, provided that the container is labelled with an indication that the substance has been reclaimed and with information on the batch number and name and address of the reclamation facility. 4. Until 31 December 2014, recycled hydrochlorofluorocarbons may be used for the maintenance or servicing of existing refrigeration, air-conditioning and heat pump equipment provided that they have been recovered from such equipment and may only be used by the undertaking which carried out the recovery as part of maintenance or servicing or for which the recovery as part of maintenance or servicing was carried out. 5. By way of derogation from Article 5, until 31 December 2019, hydrochlorofluorocarbons may be placed on the market for repackaging and subsequent export. Any undertaking carrying out the repackaging and subsequent export of hydrochlorofluorocarbons shall register with the Commission, indicating the controlled substances concerned, their estimated annual demand and the suppliers of those substances, and shall update this information when changes occur. 6. When reclaimed or recycled hydrochlorofluorocarbons are used for maintenance or servicing, the refrigeration, air-conditioning and heat pump equipment concerned shall be labelled with an indication of the type of substance, its quantity contained in the equipment and the label elements set out in Annex I to Regulation (EC) No 1272/2008 for substances or mixtures classified as Hazardous to the Ozone Layer. 7. Undertakings operating the equipment referred to in paragraph 4 containing a fluid charge of 3 kg or more shall keep a record of the quantity and type of substance recovered and added, and of the company or technician which performed the maintenance or servicing. Undertakings using reclaimed or recycled hydrochlorofluorocarbons for maintenance or servicing shall keep a record of the undertakings that have supplied reclaimed hydrochlorofluorocarbons and of the source of recycled hydrochlorofluorocarbons. 8. By way of derogation from Articles 5 and 6, the Commission may, following a request by a competent authority of a Member State and in accordance with the management procedure referred to in Article 25(2), authorise a time-limited exemption to allow the use and placing on the market of hydrochlorofluorocarbons and of products and equipment containing or relying on hydrochlorofluorocarbons where it is demonstrated that, for a particular use, technically and economically feasible alternative substances or technologies are not available or cannot be used. This exemption may not be authorised for a period which extends beyond 31 December 2019. Article 12 Quarantine and pre-shipment applications and emergency uses of methyl bromide 1. By way of derogation from Article 5(1), until 18 March 2010, methyl bromide may be placed on the market and used for quarantine and for pre-shipment applications for treatment of goods for export provided that the placing on the market and use of methyl bromide are allowed respectively under national legislation in accordance with Directive 91/414/EEC and Directive 98/8/EC. Methyl bromide may only be used on sites approved by the competent authorities of the Member State concerned and, if economically and technically feasible, subject to the condition that at least 80 % of methyl bromide released from the consignment is recovered. 2. The calculated level of methyl bromide which undertakings place on the market or use for their own account in the period from 1 January 2010 to 18 March 2010 shall not exceed 45 ODP tonnes. Each undertaking shall ensure that the calculated level of methyl bromide which it places on the market or uses for its own account for quarantine and pre-shipment applications shall not exceed 21 % of the average of the calculated level of methyl bromide which it placed on the market or used for its own account for quarantine and pre-shipment in the years 2005 to 2008. 3. In an emergency, where unexpected outbreaks of particular pests or diseases so require, the Commission may, at the request of the competent authority of a Member State, authorise the temporary production, placing on the market and use of methyl bromide, provided that the placing on the market and use of methyl bromide are allowed respectively under Directive 91/414/EEC and Directive 98/8/EC. Such authorisation shall apply for a period not exceeding 120 days and to a quantity not exceeding 20 metric tonnes and shall specify measures to be taken to reduce emissions during use. Article 13 Critical uses of halons and decommissioning of equipment containing halons 1. By way of derogation from Article 5(1), halons may be placed on the market and used for critical uses set out in Annex VI. Halons may only be placed on the market by undertakings authorised by the competent authority of the Member State concerned to store halons for critical uses. 2. The Commission shall review Annex VI and, if appropriate, adopt modifications and time-frames for the phasing out of the critical uses by defining cut-off dates for new applications and end dates for existing applications, taking into account the availability of technically and economically feasible alternatives or technologies that are acceptable from the standpoint of environment and health. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 3. Fire protection systems and fire extinguishers containing halons applied in uses referred to in paragraph 1 shall be decommissioned by the end dates to be specified in Annex VI. 4. The Commission may, at the request of the competent authority of a Member State and in accordance with the management procedure referred to in Article 25(2), grant derogations from end dates for existing applications or cut-off dates for new applications, provided those dates have been specified in Annex VI in accordance with paragraph 2, for specific cases where it is demonstrated that no technically and economically feasible alternative is available. Article 14 Transfer of rights and industrial rationalisation 1. Any producer or importer entitled to place controlled substances on the market or use them for its own account may transfer that right in respect of all or any quantities of the respective group of substances fixed in accordance with this Article to any other producer or importer of that group of substances within the Community. Any such transfer shall be notified in advance to the Commission. The transfer of the right to place on the market or use shall not imply the further right to produce or to import. 2. To the extent permitted by the Protocol, the competent authority of the Member State in which a producer\u2019s relevant production is situated may authorise that producer to exceed the calculated levels of production laid down in Article 10 and Article 11(2) for the purpose of industrial rationalisation within the Member State concerned, provided that the calculated levels of production of that Member State do not exceed the sum of the calculated levels of production of its domestic producers as laid down in Article 10 and Article 11(2) for the periods in question. The competent authority of the Member State concerned shall notify the Commission in advance of its intention to issue any such authorisation. 3. To the extent permitted by the Protocol, the Commission may, in agreement with the competent authority of the Member State in which a producer\u2019s relevant production is situated, authorise that producer to exceed the calculated levels of production laid down in Article 10 and Article 11(2) for the purpose of industrial rationalisation between Member States, provided that the combined calculated levels of production of the Member States concerned do not exceed the sum of the calculated levels of production of their domestic producers as laid down in Article 10 and Article 11(2) for the periods in question. The agreement of the competent authority of the Member State in which it is intended to reduce production shall also be required. 4. To the extent permitted by the Protocol, the Commission may, in agreement with both the competent authority of the Member State in which a producer\u2019s relevant production is situated and the government of the third country Party concerned, authorise a producer to combine the calculated levels of production laid down in Article 10 and Article 11(2) with the calculated levels of production allowed to a producer in a third country Party under the Protocol and that producer\u2019s national legislation for the purpose of industrial rationalisation with a third country Party, provided that the combined calculated levels of production by the two producers do not exceed the sum of the calculated levels of production allowed to the Community producer under Article 10 and Article 11(2) and the calculated levels of production allowed to the third country Party producer under the Protocol and any relevant national legislation. CHAPTER IV TRADE Article 15 Imports of controlled substances or of products and equipment containing or relying on controlled substances 1. Imports of controlled substances or of products and equipment other than personal effects containing or relying on those substances, shall be prohibited. 2. The prohibition set out in paragraph 1 shall not apply to imports of: (a) controlled substances to be used for laboratory and analytical uses referred to in Article 10 and Article 11(2); (b) controlled substances to be used as feedstock; (c) controlled substances to be used as process agents; (d) controlled substances for destruction by technologies referred to in Article 22(2); (e) until 31 December 2019, hydrochlorofluorocarbons to be repackaged and subsequently re-exported no later than 31 December of the following calendar year to a Party where the consumption or import of that hydrochlorofluorocarbon is not prohibited; (f) methyl bromide for emergency uses referred to in Article 12(3) or, until 31 December 2014, for repackaging and subsequent re-export for quarantine and pre-shipment applications provided that the re-export takes place during the year of import; (g) recovered, recycled or reclaimed halons, under the condition that they are only imported for critical uses referred to in Article 13(1), by undertakings authorised by the competent authority of the Member State concerned to store halons for critical uses; (h) products and equipment containing or relying on controlled substances for destruction, where applicable by technologies referred to in Article 22(2); (i) products and equipment containing or relying on controlled substances to satisfy laboratory and analytical uses referred to in Article 10 and Article 11(2); (j) products and equipment containing or relying on halon to satisfy critical uses referred to in Article 13(1); (k) products and equipment containing hydrochlorofluorocarbons for which the placing on the market has been authorised in accordance with Article 11(5). 3. Imports referred to in paragraph 2, with the exception of imports for transit through the customs territory of the Community or imports under the temporary storage, customs warehousing or free zone procedure as referred to in Regulation (EC) No 450/2008, provided that they remain in the customs territory of the Community no longer than 45 days and that they are not subsequently presented for release for free circulation in the Community, destroyed or processed, shall be subject to the presentation of an import licence. Those licences shall be issued by the Commission after verification of compliance with Articles 16 and 20. Article 16 Release for free circulation in the Community of imported controlled substances 1. The release for free circulation in the Community of imported controlled substances shall be subject to quantitative limits. The Commission shall determine those limits and allocate quotas to undertakings for the period from 1 January to 31 December 2010 and for each 12-month period thereafter in accordance with the management procedure referred to in Article 25(2). The quotas referred to in the first subparagraph shall be allocated only for the following substances: (a) controlled substances if they are used for laboratory and analytical, or critical uses, referred to in Article 10, Article 11(2) and Article 13; (b) controlled substances if they are used as feedstock; (c) controlled substances if they are used as process agents. 2. By the date specified in a notice issued by the Commission, importers of substances referred to in points (a), (b) and (c) of paragraph 1 shall declare to the Commission the anticipated demand, specifying the nature and quantities of controlled substances needed. On the basis of those declarations the Commission shall establish quantitative limits to the imports of substances referred to in points (a), (b) and (c) of paragraph 1. Article 17 Export of controlled substances or of products and equipment containing or relying on controlled substances 1. Exports of controlled substances or of products and equipment other than personal effects containing or relying on those substances, shall be prohibited. 2. The prohibition set out in paragraph 1 shall not apply to exports of: (a) controlled substances to be used for essential laboratory and analytical uses referred to in Article 10; (b) controlled substances to be used as feedstock; (c) controlled substances to be used as process agents; (d) products and equipment containing or relying on controlled substances produced in accordance with Article 10(7) or imported under point (h) or (i) of Article 15(2); (e) recovered, recycled or reclaimed halons stored for critical uses referred to in Article 13(1) by undertakings authorised by the competent authority of a Member State and products and equipment containing or relying on halon to satisfy critical uses; (f) virgin or reclaimed hydrochlorofluorocarbons for uses other than destruction; (g) until 31 December 2014, methyl bromide re-exported for quarantine and pre-shipment applications; (h) metered dose inhalers manufactured with chlorofluorocarbon the use of which has been authorised on the basis of Article 3(1) of Regulation (EC) No 2037/2000. 3. By way of derogation from paragraph 1, the Commission may, following a request by a competent authority of a Member State and in accordance with the management procedure referred to in Article 25(2), authorise the export of products and equipment containing hydrochlorofluorocarbons where it is demonstrated that in view of the economic value and the expected remaining lifetime of the specific good, the prohibition of export would impose a disproportionate burden on the exporter. Such export requires prior notification by Commission to the importing country. 4. Exports referred to in paragraphs 2 and 3 shall be subject to licensing, with the exception of re-exports subsequent to transit through the customs territory of the Community, temporary storage, customs-warehousing or free zone procedure, as referred to in Regulation (EC) No 450/2008, provided that the re-export takes place not later than 45 days after the import. That export licence shall be issued by the Commission to undertakings after verification of compliance with Article 20. Article 18 Licensing of imports and exports 1. The Commission shall set up and operate an electronic licensing system and shall decide on applications for licences within 30 days of receipt. 2. Applications for licences referred to in Articles 15 and 17 shall be submitted using the system referred to in paragraph 1. Before submitting an application for a licence undertakings shall register in that system. 3. An application for a licence shall state the following: (a) the names and the addresses of the importer and the exporter; (b) the country of import and export; (c) in the case of imports or exports of controlled substances, a description of each controlled substance, including: (i) the commercial description; (ii) the description and the Combined Nomenclature code as laid down in Annex IV; (iii) whether the substance is virgin, recovered, recycled or reclaimed; (iv) the quantity of the substance in metric kilograms; (v) in the case of halons, a declaration that they are to be imported or exported to satisfy a critical use referred to in Article 13(1), specifying which use; (d) in the case of imports or exports of products and equipment containing or relying on controlled substances: (i) the type and nature of the products and equipment; (ii) for countable items the number of units, the description and the quantity per unit in metric kilograms of each controlled substance; (iii) for uncountable items the total quantity of the product, the description and the total net quantity, in metric kilograms, of each controlled substance; (iv) the country/countries of final destination of the products and equipment; (v) whether the controlled substance contained is virgin, recycled, recovered or reclaimed; (vi) in the case of imports or exports of products and equipment containing or relying on halon, a declaration that they are to be imported or exported to satisfy a critical use referred to in Article 13(1), specifying which use; (vii) in the case of products and equipment containing or relying on hydrochlorofluorocarbons, the reference to the Commission authorisation referred to in Article 17(3); (viii) the Combined Nomenclature code of the product or equipment to be imported or exported; (e) the purpose of the proposed import, including the intended customs treatment and use, specifying where relevant the intended customs procedure; (f) the place and expected date of the proposed import or export; (g) the customs office where the goods will be declared; (h) in the case of imports of controlled substances or products and equipment for destruction, the name and address of the facility where they will be destroyed; (i) any further information deemed necessary by the competent authority of a Member State. 4. Each importer or exporter shall notify the Commission of any changes which might occur during the period of validity of the licence in relation to the data notified under paragraph 3. 5. The Commission may require a certificate attesting the nature or composition of substances to be imported or exported and may request a copy of the licence issued by the country from which the import or to which the export takes place. 6. The Commission may share the submitted data so far as necessary in specific cases with competent authorities of the Parties concerned and may reject the licence application if any relevant obligations set out in this Regulation are not complied with, or on the following grounds: (a) in the case of an import licence, where it is established based on information from the competent authorities of the country concerned that the exporter is not an undertaking authorised to trade in the respective substance in that country; (b) in the case of an export licence, where the competent authorities of the importing country have informed the Commission that the import of the controlled substance would constitute a case of illegal trade, or would adversely impact on the implementation of control measures of the importing country in place to comply with its obligations under the Protocol or would lead to an excess of the quantitative limits under the Protocol for that country. 7. The Commission shall make available a copy of each licence to the competent authority of the Member State concerned. 8. The Commission shall, as soon as possible, inform the applicant and the Member State concerned of any licence application rejected pursuant to paragraph 6, specifying the reason for the rejection. 9. The Commission may amend the list of items mentioned in paragraph 3 and Annex IV. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 19 Measures for monitoring of illegal trade The Commission may adopt additional measures for the monitoring of controlled substances or new substances and of products and equipment containing or relying on controlled substances placed under temporary storage, customs warehousing or free zone procedure or in transit through the customs territory of the Community and subsequently re-exported, on the basis of an evaluation of the potential risks of illegal trade linked to such movements, taking into account the environmental benefits and socioeconomic impacts of such measures. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 20 Trade with a State not party to the Protocol and a territory not covered by the Protocol 1. Import and export of controlled substances and of products and equipment containing or relying on controlled substances from and to any State not party to the Protocol shall be prohibited. 2. The Commission may adopt rules applicable to the release for free circulation in the Community of products and equipment imported from any State not party to the Protocol which were produced using controlled substances but do not contain substances which can be positively identified as controlled substances. The identification of such products and equipment shall comply with periodical technical advice given to the Parties. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 3. By way of derogation from paragraph 1, trade with any State not party to the Protocol in controlled substances and products and equipment containing or relying on such substances or which are produced by means of one or more such substances may be authorised by the Commission, to the extent that the State not party to the Protocol is determined by a meeting of the Parties pursuant to Article 4(8) of the Protocol to be in full compliance with the Protocol and has submitted data to that effect as specified in Article 7 of the Protocol. The Commission shall act in accordance with the management procedure referred to in Article 25(2) of this Regulation. 4. Subject to any decision taken under the second subparagraph, paragraph 1 shall apply to any territory not covered by the Protocol as they apply to any State not party to the Protocol. Where the authorities of a territory not covered by the Protocol are in full compliance with the Protocol and have submitted data to that effect as specified in Article 7 of the Protocol, the Commission may decide that some or all of the provisions of paragraph 1 of this Article shall not apply in respect of that territory. The Commission shall act in accordance with the management procedure referred to in Article 25(2). Article 21 List of products and equipment containing or relying on controlled substances No later than 1 January 2010, the Commission shall make available a list of products and equipment which might contain or rely on controlled substances and of Combined Nomenclature codes for guidance of the Member States\u2019 customs authorities. CHAPTER V EMISSION CONTROL Article 22 Recovery and destruction of used controlled substances 1. Controlled substances contained in refrigeration, air-conditioning and heat pump equipment, equipment containing solvents or fire protection systems and fire extinguishers shall, during the maintenance or servicing of equipment or before the dismantling or disposal of equipment, be recovered for destruction, recycling or reclamation. 2. Controlled substances and products containing such substances shall only be destroyed by approved technologies listed in Annex VII or, in the case of controlled substances not referred to in that Annex, by the most environmentally acceptable destruction technology not entailing excessive costs, provided that the use of those technologies complies with Community and national legislation on waste and that additional requirements under such legislation are met. 3. The Commission may amend Annex VII in order to take new technological developments into account. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 4. Controlled substances contained in products and equipment other than those mentioned in paragraph 1 shall, if technically and economically feasible, be recovered for destruction, recycling or reclamation, or shall be destroyed without prior recovery, applying the technologies referred to in paragraph 2. The Commission shall establish an Annex to this Regulation with a list of products and equipment for which the recovery of controlled substances or destruction of products and equipment without prior recovery of controlled substances shall be considered technically and economically feasible, specifying, if appropriate, the technologies to be applied. Any draft measure to establish such an Annex shall be accompanied and supported by a full economic assessment of costs and benefits, taking into account the individual circumstances of Member States. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 5. Member States shall take steps to promote the recovery, recycling, reclamation and destruction of controlled substances and shall define the minimum qualification requirements for the personnel involved. The Commission shall evaluate the measures taken by the Member States and may in the light of this evaluation and of technical and other relevant information, as appropriate, adopt measures regarding those minimum qualification requirements. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 23 Leakages and emissions of controlled substances 1. Undertakings shall take all precautionary measures practicable to prevent and minimise any leakages and emissions of controlled substances. 2. Undertakings operating refrigeration, air conditioning or heat pump equipment, or fire protection systems, including their circuits, which contain controlled substances shall ensure that the stationary equipment or systems: (a) with a fluid charge of 3 kg or more of controlled substances are checked for leakage at least once every 12 months; this shall not apply to equipment with hermetically sealed systems, which are labelled as such and contain less than 6 kg of controlled substances; (b) with a fluid charge of 30 kg or more of controlled substances are checked for leakage at least once every 6 months; (c) with a fluid charge of 300 kg or more of controlled substances are checked for leakage at least once every 3 months; and that any detected leakage is repaired as soon as possible and in any event within 14 days. The equipment or system shall be checked for leakage within 1 month after a leak has been repaired to ensure that the repair has been effective. 3. Undertakings referred to in paragraph 2 shall maintain records on the quantity and type of controlled substances added and the quantity recovered during maintenance, servicing and final disposal of the equipment or system referred to in that paragraph. They shall also maintain records of other relevant information including the identification of the company or technician which performed the maintenance or servicing, as well as the dates and results of the leakage checks carried out. These records shall be made available on request to the competent authority of a Member State and to the Commission. 4. Member States shall define the minimum qualification requirements for the personnel carrying out activities referred to in paragraph 2. In the light of an evaluation of these measures taken by the Member States and of technical and other relevant information, the Commission may adopt measures regarding the harmonisation of those minimum qualification requirements. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 5. Undertakings shall take all precautionary measures practicable to prevent and minimise any leakages and emissions of controlled substances used as feedstock and as process agents. 6. Undertakings shall take all precautionary measures practicable to prevent and minimise any leakage and emissions of controlled substances inadvertently produced in the course of the manufacture of other chemicals. 7. The Commission may establish a list of technologies or practices to be used by undertakings to prevent and minimise any leakage and emissions of controlled substances. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). CHAPTER VI NEW SUBSTANCES Article 24 New substances 1. The production, import, placing on the market, use and export of new substances in Part A of Annex II are prohibited. This prohibition does not apply to new substances if they are used as feedstock or for laboratory and analytical uses, to imports for transit through the customs territory of the Community or imports under the temporary storage, customs warehousing or free zone procedure as referred to in Regulation (EC) No 450/2008, unless such imports have been assigned another customs-approved treatment or use as referred to in that Regulation, or to exports subsequent to imports already exempted. 2. The Commission shall, if appropriate, include in Part A of Annex II substances that are included in Part B of that Annex that are found to be exported, imported, produced or put on the market in significant quantities and that are found by the Scientific Assessment Panel under the Protocol to have a significant ozone-depleting potential, and shall, if appropriate, determine possible exemptions from paragraph 1. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 3. In the light of relevant scientific information, the Commission shall, if appropriate, include in Part B of Annex II any substances that are not controlled substances but that are found by the Scientific Assessment Panel under the Protocol or another recognised authority of equivalent stature to have a significant ozone-depleting potential. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). CHAPTER VII COMMITTEE, REPORTING, INSPECTION AND PENALTIES Article 25 Committee 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at 1 month. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 26 Reporting by the Member States 1. Each year by 30 June Member States shall report the following information in an electronic format to the Commission, for the previous calendar year: (a) the quantities of methyl bromide authorised, pursuant to Article 12(2) and (3), for different treatments for quarantine and pre-shipment purposes used in their territory, specifying the purposes for which methyl bromide was used, and the progress in evaluating and using alternatives; (b) the quantities of halons installed, used and stored for critical uses, pursuant to Article 13(1), the measures taken to reduce their emissions and an estimate of such emissions, and progress in evaluating and using adequate alternatives; (c) cases of illegal trade, in particular those detected during the inspections carried out pursuant to Article 28. 2. The Commission shall, in accordance with the management procedure referred to in Article 25(2), determine the format for the submission of the information referred to in paragraph 1. 3. The Commission may amend paragraph 1. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 27 Reporting by undertakings 1. Each year by 31 March, each undertaking shall communicate to the Commission, sending a copy to the competent authority of the Member State concerned, the data listed in paragraphs 2 to 6 for each controlled substance and each new substance listed in Annex II for the previous calendar year. 2. Each producer shall communicate the following data: (a) its total production of each substance referred to in paragraph 1; (b) any production placed on the market or used for the producer\u2019s own account within the Community, separately identifying production for feedstock, process agent and other uses; (c) any production to meet the essential laboratory and analytical uses in the Community, licensed in accordance with Article 10(6); (d) any production authorised under Article 10(8) to satisfy essential laboratory and analytical uses of Parties; (e) any increase in production authorised under Article 14(2), (3) and (4) in connection with industrial rationalisation; (f) any quantity recycled, reclaimed or destroyed and the technology used for the destruction, including amounts produced and destroyed as by-product as referred to in Article 3(14); (g) any stocks; (h) any purchases from and sales to other producers in the Community. 3. Each importer shall communicate for each substance referred to in paragraph 1 the following data: (a) any quantities released for free circulation in the Community, separately identifying imports for feedstock and process agent uses, for essential laboratory and analytical uses licensed in accordance with Article 10(6), for use in quarantine and pre-shipment applications and for destruction. Importers which imported controlled substances for destruction shall also communicate the actual final destination or destinations of each of the substances, providing separately for each destination the quantity of each of the substances and the name and address of destruction facility where the substance was delivered; (b) any quantities imported under other customs procedures, separately identifying the customs procedure and the designated uses; (c) any quantities of used substances referred to in paragraph 1 imported for recycling or reclamation; (d) any stocks; (e) any purchases from and sales to other undertakings in the Community; (f) the exporting country. 4. Each exporter shall communicate for each substances referred to in paragraph 1 the following data: (a) any quantities of such substances exported, separately identifying quantities exported to each country of destination and quantities exported for feedstock and process agent uses, essential laboratory and analytical uses, critical uses and for quarantine and pre-shipment applications; (b) any stocks; (c) any purchases from and sales to other undertakings in the Community; (d) the country of destination. 5. Each undertaking destroying controlled substances referred to in paragraph 1 and not covered by paragraph 2 shall communicate the following data: (a) any quantities of such substances destroyed, including quantities contained in products or equipment; (b) any stocks of such substances waiting to be destroyed, including quantities contained in products or equipment; (c) technology used for the destruction. 6. Each undertaking using controlled substances as feedstock or process agents shall communicate the following data: (a) any quantities of such substances used as feedstock or process agents; (b) any stocks of such substances; (c) the processes and emissions involved. 7. Each year before 31 March, each producer or importer which holds a licence under Article 10(6) shall, for each substance for which an authorisation has been received, report to the Commission, sending a copy to the competent authority of the Member State concerned, the nature of the use, the quantities used during the previous year, the quantities held in stock, any quantities recycled, reclaimed or destroyed, and the quantity of products and equipment containing or relying on those substances placed on the Community market and/or exported. 8. The Commission shall take appropriate steps to protect the confidentiality of the information submitted to it. 9. The format of the reports referred to in paragraphs 1 to 7 shall be established in accordance with the management procedure referred to in Article 25(2). 10. The Commission may amend the reporting requirements laid down in paragraphs 1 to 7. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 28 Inspection 1. Member States shall conduct inspections on the compliance of undertakings with this Regulation, following a risk-based approach, including inspections on imports and exports of controlled substances as well as of products and equipment containing or relying on those substances. The competent authorities of the Member States shall carry out the investigations which the Commission considers necessary under this Regulation. 2. Subject to the agreement of the Commission and of the competent authority of the Member State within the territory of which the investigations are to be made, the officials of the Commission shall assist the officials of that authority in the performance of their duties. 3. In carrying out the tasks assigned to it by this Regulation, the Commission may obtain all necessary information from the governments and competent authorities of the Member States and from undertakings. When requesting information from an undertaking the Commission shall at the same time forward a copy of the request to the competent authority of the Member State within the territory of which the undertaking\u2019s seat is situated. 4. The Commission shall take appropriate action to promote an adequate exchange of information and cooperation between national authorities and between national authorities and the Commission. The Commission shall take appropriate steps to protect the confidentiality of information obtained under this Article. 5. At the request of another Member State, a Member State may conduct inspections of undertakings or investigations of undertakings suspected of being engaged in the illegal movement of controlled substances and which are operating on the territory of that Member State. Article 29 Penalties Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 30 June 2011 at the latest and shall also notify it without delay of any subsequent amendment affecting them. CHAPTER VIII FINAL PROVISIONS Article 30 Repeal Regulation (EC) No 2037/2000 shall be repealed as from 1 January 2010. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex VIII. Article 31 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 January 2010. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 September 2009. For the European Parliament The President J. BUZEK For the Council The President C. MALMSTR\u00d6M (1) OJ C 100, 30.4.2009, p. 135. (2) Opinion of the European Parliament of 25 March 2009 (not yet published in the Official Journal) and Council Decision of 27 July 2009. (3) OJ L 244, 29.9.2000, p. 1. (4) OJ L 297, 31.10.1988, p. 8. (5) OJ L 258, 26.9.2008, p. 68. (6) OJ L 123, 24.4.1998, p. 1. (7) OJ L 230, 19.8.1991, p. 1. (8) OJ L 307, 24.11.2003, p. 1. (9) OJ 196, 16.8.1967, p. 1. (10) OJ L 200, 30.7.1999, p. 1. (11) OJ L 353, 31.12.2008, p. 1. (12) OJ L 281, 23.11.1995, p. 31. (13) OJ L 8, 12.1.2001, p. 1. (14) OJ L 118, 27.4.2001, p. 41. (15) OJ L 184, 17.7.1999, p. 23. (16) OJ L 114, 27.4.2006, p. 9. Directive 2006/12/EC is repealed by Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3) with effect from 12 December 2010. (17) OJ L 377, 31.12.1991, p. 20. (18) OJ L 37, 13.2.2003, p. 24. ANNEX I CONTROLLED SUBSTANCES Group Substance Ozone-depleting potential (1) Group I CFCl3 CFC-11 Trichlorofluoromethane 1,0 CF2Cl2 CFC-12 Dichlorodifluoromethane 1,0 C2F3Cl3 CFC-113 Trichlorotrifluoroethane 0,8 C2F4Cl2 CFC-114 Dichlorotetrafluoroethane 1,0 C2F5Cl CFC-115 Chloropentafluoroethane 0,6 Group II CF3Cl CFC-13 Chlorotrifluoromethane 1,0 C2FCl5 CFC-111 Pentachlorofluoroethane 1,0 C2F2Cl4 CFC-112 Tetrachlorodifluoroethane 1,0 C3FCl7 CFC-211 Heptachlorofluoropropane 1,0 C3F2Cl6 CFC-212 Hexachlorodifluoropropane 1,0 C3F3Cl5 CFC-213 Pentachlorotrifluoropropane 1,0 C3F4Cl4 CFC-214 Tetrachlorotetrafluoropropane 1,0 C3F5Cl3 CFC-215 Trichloropentafluoropropane 1,0 C3F6Cl2 CFC-216 Dichlorohexafluoropropane 1,0 C3F7Cl CFC-217 Chloroheptafluoropropane 1,0 Group III CF2BrCl halon-1211 Bromochlorodifluoromethane 3,0 CF3Br halon-1301 Bromotrifluoromethane 10,0 C2F4Br2 halon-2402 Dibromotetrafluoroethane 6,0 Group IV CCl4 CTC Tetrachloromethane (carbon tetrachloride) 1,1 Group V C2H3Cl3 (2) 1,1,1-TCA 1,1,1-Trichloroethane (methylchloroform) 0,1 Group VI CH3Br methyl bromide Bromomethane 0,6 Group VII CHFBr2 HBFC-21 B2 Dibromofluoromethane 1,00 CHF2Br HBFC-22 B1 Bromodifluoromethane 0,74 CH2FBr HBFC-31 B1 Bromofluoromethane 0,73 C2HFBr4 HBFC-121 B4 Tetrabromofluoroethane 0,8 C2HF2Br3 HBFC-122 B3 Tribromodifluoroethane 1,8 C2HF3Br2 HBFC-123 B2 Dibromotrifluoroethane 1,6 C2HF4Br HBFC-124 B1 Bromotetrafluoroethane 1,2 C2H2FBr3 HBFC-131 B3 Tribromofluoroethane 1,1 C2H2F2Br2 HBFC-132 B2 Dibromodifluoroethane 1,5 C2H2F3Br HBFC-133 B1 Bromotrifluoroethane 1,6 C2H3FBr2 HBFC-141 B2 Dibromofluoroethane 1,7 C2H3F2Br HBFC-142 B1 Bromodifluoroethane 1,1 C2H4FBr HBFC-151 B1 Bromofluoroethane 0,1 C3HFBr6 HBFC-221 B6 Hexabromofluoropropane 1,5 C3HF2Br5 HBFC-222 B5 Pentabromodifluoropropane 1,9 C3HF3Br4 HBFC-223 B4 Tetrabromotrifluoropropane 1,8 C3HF4Br3 HBFC-224 B3 Tribromotetrafluoropropane 2,2 C3HF5Br2 HBFC-225 B2 Dibromopentafluoropropane 2,0 C3HF6Br HBFC-226 B1 Bromohexafluoropropane 3,3 C3H2FBr5 HBFC-231 B5 Pentabromofluoropropane 1,9 C3H2F2Br4 HBFC-232 B4 Tetrabromodifluoropropane 2,1 C3H2F3Br3 HBFC-233 B3 Tribromotrifluoropropane 5,6 C3H2F4Br2 HBFC-234 B2 Dibromotetrafluoropropane 7,5 C3H2F5Br HBFC-235 B1 Bromopentafluoropropane 1,4 C3H3FBr4 HBFC-241 B4 Tetrabromofluoropropane 1,9 C3H3F2Br3 HBFC-242 B3 Tribromodifluoropropane 3,1 C3H3F3Br2 HBFC-243 B2 Dibromotrifluoropropane 2,5 C3H3F4Br HBFC-244 B1 Bromotetrafluoropropane 4,4 C3H4FBr3 HBFC-251 B1 Tribromofluoropropane 0,3 C3H4F2Br2 HBFC-252 B2 Dibromodifluoropropane 1,0 C3H4F3Br HBFC-253 B1 Bromotrifluoropropane 0,8 C3H5FBr2 HBFC-261 B2 Dibromofluoropropane 0,4 C3H5F2Br HBFC-262 B1 Bromodifluoropropane 0,8 C3H6FBr HBFC-271 B1 Bromofluoropropane 0,7 Group VIII CHFCl2 HCFC-21 (3) Dichlorofluoromethane 0,040 CHF2Cl HCFC-22 (3) Chlorodifluoromethane 0,055 CH2FCl HCFC-31 Chlorofluoromethane 0,020 C2HFCl4 HCFC-121 Tetrachlorofluoroethane 0,040 C2HF2Cl3 HCFC-122 Trichlorodifluoroethane 0,080 C2HF3Cl2 HCFC-123 (3) Dichlorotrifluoroethane 0,020 C2HF4Cl HCFC-124 (3) Chlorotetrafluoroethane 0,022 C2H2FCl3 HCFC-131 Trichlorofluoroethane 0,050 C2H2F2Cl2 HCFC-132 Dichlorodifluoroethane 0,050 C2H2F3Cl HCFC-133 Chlorotrifluoroethane 0,060 C2H3FCl2 HCFC-141 Dichlorofluoroethane 0,070 CH3CFCl2 HCFC-141b (3) 1,1-Dichloro-1-fluoroethane 0,110 C2H3F2Cl HCFC-142 Chlorodifluoroethane 0,070 CH3CF2Cl HCFC-142b (3) 1-Chloro-1,1-difluoroethane 0,065 C2H4FCl HCFC-151 Chlorofluoroethane 0,005 C3HFCl6 HCFC-221 Hexachlorofluoropropane 0,070 C3HF2Cl5 HCFC-222 Pentachlorodifluoropropane 0,090 C3HF3Cl4 HCFC-223 Tetrachlorotrifluoropropane 0,080 C3HF4Cl3 HCFC-224 Trichlorotetrafluoropropane 0,090 C3HF5Cl2 HCFC-225 Dichloropentafluoropropane 0,070 CF3CF2CHCl2 HCFC-225ca (3) 3,3-Dichloro-1,1,1,2,2-pentafluoropropane 0,025 CF2ClCF2CHClF HCFC-225cb (3) 1,3-Dichloro-1,1,2,2,3-pentafluoropropane 0,033 C3HF6Cl HCFC-226 Chlorohexafluoropropane 0,100 C3H2FCl5 HCFC-231 Pentachlorofluoropropane 0,090 C3H2F2Cl4 HCFC-232 Tetrachlorodifluoropropane 0,100 C3H2F3Cl3 HCFC-233 Trichlorotrifluoropropane 0,230 C3H2F4Cl2 HCFC-234 Dichlorotetrafluoropropane 0,280 C3H2F5Cl HCFC-235 Chloropentafluoropropane 0,520 C3H3FCl4 HCFC-241 Tetrachlorofluoropropane 0,090 C3H3F2Cl3 HCFC-242 Trichlorodifluoropropane 0,130 C3H3F3Cl2 HCFC-243 Dichlorotrifluoropropane 0,120 C3H3F4Cl HCFC-244 Chlorotetrafluoropropane 0,140 C3H4FCl3 HCFC-251 Trichlorofluoropropane 0,010 C3H4F2Cl2 HCFC-252 Dichlorodifluoropropane 0,040 C3H4F3Cl HCFC-253 Chlorotrifluoropropane 0,030 C3H5FCl2 HCFC-261 Dichlorofluoropropane 0,020 C3H5F2Cl HCFC-262 Chlorodifluoropropane 0,020 C3H6FCl HCFC-271 Chlorofluoropropane 0,030 Group IX CH2BrCl BCM Bromochloromethane 0,12 (1) The figures relating to ozone-depleting potential are estimates based on existing knowledge and will be reviewed and revised periodically in the light of decisions taken by the Parties. (2) This formula does not refer to 1,1,2-trichloroethane. (3) Identifies the most commercially viable substance as prescribed in the Protocol. ANNEX II NEW SUBSTANCES Part A: Substances restricted under Article 24(1) Substance Ozone-depleting potential CBr2 F2 Dibromodifluoromethane (halon-1202) 1,25 Part B: Substances to be reported on under Article 27 Substance Ozone-depleting potential (1) C3H7Br 1-Bromopropane (n-propyl bromide) 0,02 \u2014 0,10 C2H5Br Bromoethane (ethyl bromide) 0,1 \u2014 0,2 CF3I Trifluoroiodomethane (trifluoromethyl iodide) 0,01 \u2014 0,02 CH3Cl Chloromethane (methyl chloride) 0,02 (1) The figures relating to ozone-depleting potential are estimates based on existing knowledge and will be reviewed and revised periodically in the light of decisions taken by the Parties. ANNEX III Processes in which controlled substances are used as process agents as referred to in Article 3(12): (a) use of carbon tetrachloride for the elimination of nitrogen trichloride in the production of chlorine and caustic soda; (b) use of carbon tetrachloride in the recovery of chlorine in tail gas from production of chlorine; (c) use of carbon tetrachloride in the manufacture of chlorinated rubber; (d) use of carbon tetrachloride in the manufacture of poly-phenylene-terephthalamide; (e) use of CFC-12 in the photochemical synthesis of perfluoropolyetherpolyperoxide precursors of Z-perfluoropolyethers and difunctional derivatives; (f) use of CFC-113 in the preparation of perfluoropolyether diols with high functionality; (g) use of carbon tetrachloride in production of Cyclodime; (h) use of hydrochlorofluorocarbons in the processes set out in points (a) to (g) when used to replace the chlorofluorocarbon or carbon tetrachloride. ANNEX IV Groups, Combined Nomenclature codes (1) and descriptions for the substances referred to in Annex I Group CN code Description Group I 2903 41 00 Trichlorofluoromethane 2903 42 00 Dichlorodifluoromethane 2903 43 00 Trichlorotrifluoroethanes 2903 44 10 Dichlorotetrafluoroethanes 2903 44 90 Chloropentafluoroethane Group II 2903 45 10 Chlorotrifluoromethane 2903 45 15 Pentachlorofluoroethane 2903 45 20 Tetrachlorodifluoroethanes 2903 45 25 Heptachlorofluoropropanes 2903 45 30 Hexachlorodifluoropropanes 2903 45 35 Pentachlorotrifluoropropanes 2903 45 40 Tetrachlorotetrafluoropropanes 2903 45 45 Trichloropentafluoropropanes 2903 45 50 Dichlorohexafluoropropanes 2903 45 55 Chloroheptafluoropropanes Group III 2903 46 10 Bromochlorodifluoromethane 2903 46 20 Bromotrifluoromethane 2903 46 90 Dibromotetrafluoroethanes Group IV 2903 14 00 Carbon tetrachloride Group V 2903 19 10 1,1,1-Trichloroethane (methyl chloroform) Group VI 2903 39 11 Bromomethane (methyl bromide) Group VII 2903 49 30 Hydrobromofluoromethanes, -ethanes or -propanes Group VIII 2903 49 11 Chlorodifluoromethane (HCFC-22) 2903 49 15 1,1-Dichloro-1-fluoroethane (HCFC-141b) 2903 49 19 Other Hydrochlorofluoromethanes, -ethanes or -propanes (HCFCs) Group IX ex 2903 49 80 Bromochloromethane Mixtures 3824 71 00 Mixtures containing chlorofluorocarbons (CFCs), whether or not containing hydrochlorofluorocarbons (HCFCs), perfluorocarbons (PFCs) or hydrofluorocarbons (HFCs) 3824 72 00 Mixtures containing bromochlorodifluoromethane, bromotrifluoromethane or dibromotetrafluoroethanes 3824 73 00 Mixtures containing hydrobromofluorocarbons (HBFCs) 3824 74 00 Mixtures containing hydrochlorofluorocarbons (HCFCs), whether or not containing perfluorocarbons (PFCs) or hydrofluorocarbons (HFCs), but not containing chlorofluorocarbons (CFCs) 3824 75 00 Mixtures containing carbon tetrachloride 3824 76 00 Mixtures containing 1,1,1-trichloroethane (methyl chloroform) 3824 77 00 Mixtures containing bromomethane (methyl bromide) or bromochloromethane (1) An \u2018ex\u2019 before a code implies that substances other than those referred to in the column \u2018Description\u2019 may also fall under that subheading. ANNEX V Conditions for the placing on the market and further distribution of controlled substances for essential laboratory and analytical uses referred to in Article 10(3) 1. Controlled substances for essential laboratory and analytical uses shall contain only controlled substances manufactured to the following purities: Substance % CTC (reagent grade) 99,5 1,1,1-trichloroethane 99,0 CFC 11 99,5 CFC 13 99,5 CFC 12 99,5 CFC 113 99,5 CFC 114 99,5 Other controlled substances with a boiling point > 20 \u00b0C 99,5 Other controlled substances with a boiling point < 20 \u00b0C 99,0 These pure controlled substances may be subsequently mixed by manufacturers, agents, or distributors with other chemicals controlled or not controlled by the Protocol as is customary for laboratory and analytical uses. 2. These high purity substances and mixtures containing controlled substances shall be supplied only in re-closable containers or high pressure cylinders smaller than three litres or in 10 millilitre or smaller glass ampoules, marked clearly as substances that deplete the ozone layer, restricted to laboratory and analytical uses and specifying that used or surplus substances should be collected and recycled, if practical. The material should be destroyed if recycling is not practical. ANNEX VI CRITICAL USES OF HALON Use of halon 1301: \u2014 in aircraft for the protection of crew compartments, engine nacelles, cargo bays and dry bays, and fuel tank inerting, \u2014 in military land vehicles and naval vessels for the protection of spaces occupied by personnel and engine compartments, \u2014 for the making inert of occupied spaces where flammable liquid and/or gas release could occur in the military and oil, gas and petrochemical sector, and in existing cargo ships, \u2014 for the making inert of existing manned communication and command centres of the armed forces or others, essential for national security, \u2014 for the making inert of spaces where there may be a risk of dispersion of radioactive matter, \u2014 in the Channel Tunnel and associated installations and rolling stock. Use of halon 1211: \u2014 in military land vehicles and naval vessels for the protection of spaces occupied by personnel and engine compartments, \u2014 in hand-held fire extinguishers and fixed extinguisher equipment for engines for use on board aircraft, \u2014 in aircraft for the protection of crew compartments, engine nacelles, cargo bays and dry bays, \u2014 in fire extinguishers essential to personal safety used for initial extinguishing by fire brigades, \u2014 in military and police fire extinguishers for use on persons. Use of halon 2402 only in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia: \u2014 in aircraft for the protection of crew compartments, engine nacelles, cargo bays and dry bays and fuel tank inerting, \u2014 in military land vehicles and naval vessels for the protection of spaces occupied by personnel and engine compartments, \u2014 for the making inert of occupied spaces where flammable liquid and/or gas release could occur in the military and oil, gas and petrochemical sectors, and in existing cargo ships, \u2014 for the making inert of existing manned communication and command centres of the armed forces or others, essential for national security, \u2014 for the making inert of spaces where there may be a risk of dispersion of radioactive matter, \u2014 in hand-held fire extinguishers and fixed extinguisher equipment for engines for use on board aircraft, \u2014 in fire extinguishers essential to personal safety used for initial extinguishing by fire brigades, \u2014 in military and police fire extinguishers for use on persons. Use of halon 2402 only in Bulgaria: \u2014 in aircraft for the protection of crew compartments, engine nacelles, cargo bays and dry bays, and fuel tank inerting, \u2014 in military land vehicles and naval vessels for the protection of spaces occupied by personnel and engine compartments. ANNEX VII DESTRUCTION TECHNOLOGIES REFERRED TO IN ARTICLE 22(1) Applicability Technology Controlled substances (1) (2) Dilute sources (3) Controlled substances listed in Annex I, groups I, II, IV, V, VIII Halons listed in Annex I group III Foam Destruction and removal efficiency (DRE) (4) 99,99 % 99,99 % 95 % Cement kilns Approved (5) Not Approved Not applicable Liquid injection incineration Approved Approved Not applicable Gaseous/fume oxidation Approved Approved Not applicable Municipal solid waste incineration Not applicable Not applicable Approved Reactor cracking Approved Not Approved Not applicable Rotary kiln incineration Approved Approved Approved Argon plasma arc Approved Approved Not applicable Inductively coupled radio frequency plasma Approved Approved Not applicable Microwave plasma Approved Not Approved Not applicable Nitrogen plasma arc Approved Not Approved Not applicable Gas phase catalytic dehalogenation Approved Not Approved Not applicable Superheated steam reactor Approved Not Approved Not applicable (1) Controlled substances not listed below shall be destroyed by the most environmentally acceptable destruction technology not entailing excessive costs. (2) Concentrated sources refer to virgin, recovered and reclaimed ozone-depleting substances. (3) Dilute sources refer to ozone-depleting substances contained in a matrix of a solid, for example foam. (4) The DRE criterion presents technology capability on which approval of the technology is based. It does not always reflect the day-to-day performance achieved, which in itself will be controlled by national minimum standards. (5) Approved by the Parties. ANNEX VIII CORRELATION TABLE Regulation (EC) No 2037/2000 This Regulation Article 1 Article 1 and 2 Article 2 Article 3 Article 3(1) first subparagraph Article 4(1) Article 3(1) second subparagraph Article 10(2) and (4) Article 3(2) point (i) Article 4 Article 3(2) point (ii) first subparagraph \u2014 Article 3(2) point (ii) second subparagraph Article 12(3) Article 3(3) Article 11(1) Article 3(4) Article 10(6) first sentence Article 3(5) Article 10(7) Article 3(6) \u2014 Article 3(7) Article 10(8) Article 3(8) Article 14(2) Article 3(9) Article 14(3) Article 3(10) Article 14(4) Article 4(1) Article 5(1) Article 4(2) point (i) Article 5(1) Article 4(2) point (ii) \u2014 Article 4(2) point (iii) first subparagraph Article 12(1) and (2) Article 4(2) point (iii) second subparagraph Article 26(1) point (a) Article 4(2) point (iii) third subparagraph Article 12(2) Article 4(2) point (iv) \u2014 Article 4(3) point (i) Article 5(1) Article 4(3) point (ii) \u2014 Article 4(3) point (iii) \u2014 Article 4(3) point (iv) \u2014 Article 4(4) point (i)(a) Article 9 Article 4(4) point (i)(b) first indent Article 7(1) and Article 8(1) Article 4(4) point (i)(b) second indent Article 10(1) and Article 12(3) Article 4(4) point (ii) \u2014 Article 4(4) point (iii) \u2014 Article 4(4) point (iv) first sentence Article 13(1) Article 4(4) point (iv) second sentence Article 27(1) Article 4(4) point (v) Article 6(2) Article 4(5) Article 14(1) Article 4(6) Article 6 Article 4(6) \u2014 Article 5(1) Article 5(1) Article 5(2) point (a) Article 11(2) Article 5(2) point (b) Article 7(1) Article 5(2) point (c) Article 8(1) Article 5(3) \u2014 Article 5(4) first sentence Article 11(8) Article 5(4) second sentence \u2014 Article 5(5) \u2014 Article 5(6) \u2014 Article 5(7) Article 11(8) Article 6(1) first sentence Article 15(3) Article 6(1) second sentence \u2014 Article 6(2) \u2014 Article 6(3) Article 18(3) Article 6(4) Article 18(5) Article 6(5) Article 18(9) Article 7 Article 16(1) Article 8 Article 20(1) Article 9(1) Article 20(1) Article 9(2) Article 21 Article 10 Article 20(2) Article 11(1) Article 17(1) and (2) Article 11(2) Article 20(1) Article 11(3) Article 20(1) Article 11(4) \u2014 Article 12(1) Article 17(4) Article 12(2) Article 18(4) Article 12(3) Article 18(5) Article 12(4) Article 18(3) and (4) Article 13 Article 20(3) Article 14 Article 20(4) Article 15 \u2014 Article 16(1) Article 22(1) Article 16(2) \u2014 Article 16(3) Article 22(3) Article 16(4) \u2014 Article 16(5) Article 22(5) Article 16(6) \u2014 Article 16(7) \u2014 Article 17 Article 23 Article 18 Article 25 Article 19 Article 25 Article 20(1) Article 28(3) Article 20(2) Article 28(3) Article 20(3) Article 28(1) Article 20(4) Article 28(2) Article 20(5) Article 28(4) Article 21 Article 29 Article 22 Article 24 Article 23 Article 30 Article 24 Article 31 Annex I Annex I Annex III \u2014 Annex IV Annex IV Annex V \u2014 Annex VI Annex III Annex VII Annex VI", "summary": "Substances depleting the ozone layer Substances depleting the ozone layer SUMMARY OF: Regulation (EC) No 1005/2009 on substances that deplete the ozone layer (Ozone Regulation) WHAT IS THE AIM OF THE REGULATION? It lays down rules on the production, import, export, sale, use, recovery, recycling, reclamation and destruction of substances that damage the ozone layer. It sets out reporting requirements and measures for products and equipment that use these substances. It has been slightly amended four times. KEY POINTS As a general rule, the production and sale of controlled substances, such as halons (to extinguish fires), methyl bromide (to control pests) and hydrochlorofluorocarbons (used in fridges and air conditioning systems), whose manufacture or use is regulated, are prohibited. Some exemptions, under clear conditions, are allowed, for example if they are used as feedstock*, as process agents* or for laboratory or analytical use. Use of methyl bromide has been banned since March 2010, except during emergency quarantines to prevent the spread of disease or pests. In each case, the Commission must give its temporary authorisation. Fire protection systems and fire extinguishers containing halons may be used in certain circumstances. Alternatives are increasingly available and amending Regulation (EU) No 744/2010 sets out detailed cut-off dates. These range from 2013 to 2040 depending on the halon use. Imports and exports of controlled substances and products containing them are essentially banned. Where they are allowed, a licence system operates. In 2013, the Commission made this more flexible for halons used in aircraft. Recovery systems must be in place to destroy, recycle or reclaim controlled substances used in refrigeration, air-conditioning and heat pump equipment, fire extinguishers and protection systems and items containing solvents. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2010. BACKGROUND For more information, see: Ozone regulation (European Commission). KEY TERMS Feedstock: any controlled substance or new substance that undergoes chemical transformation in a process in which it is entirely converted from its original composition and whose emissions are insignificant. Process agents: controlled substances used as chemical process agents in the applications listed in Annex III. MAIN DOCUMENT Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, pp. 1-30) Successive amendments to Regulation (EC) No 1005/2009 have been incorporated in the original text. This consolidated version is of documentary value only. last update 12.02.2021"}
{"article": "21.5.2009 EN Official Journal of the European Union L 126/13 REGULATION (EC) No 401/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network (Codified version) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 175 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Council Regulation (EEC) No 1210/90 of 7 May 1990 on the establishment of the European Environment Agency and the European Environment Information and Observation Network (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Regulation should be codified. (2) The Treaty provides for the development and implementation of a Community policy on the environment, and lays down the objectives and principles which should govern such policy. (3) Environmental protection requirements are to be a component of the Community\u2019s other policies. (4) According to Article 174 of the Treaty, in preparing its action relating to the environment the Community is to take account, inter alia, of the available scientific and technical data. (5) Collection, processing and analysis of environmental data at European level are necessary in order to provide objective, reliable and comparable information which will enable the Community and the Member States to take the requisite measures to protect the environment, to assess the results of such measures and to ensure that the public is properly informed about the state of the environment. (6) There already exist in the Community and the Member States facilities providing such information and services. (7) They should form the basis for the European Environment Information and Observation Network to be coordinated at Community level by the European Environment Agency. (8) The general principles and limits governing the exercise of the right of access to documents, provided for in Article 255 of the Treaty, have been laid down by Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (5). (9) The Agency should cooperate with existing structures at Community level to enable the Commission to ensure full application of Community legislation on the environment. (10) The status and structure of the Agency should correspond to the objective character of the results it is intended to produce and allow it to carry out its functions in close cooperation with the existing national and international facilities. (11) The Agency should be granted legal autonomy while maintaining close links with the Community institutions and the Member States. (12) It is desirable to provide for the Agency to be open to other countries which share the concern of the Community and the Member States for the objectives of the Agency under agreements to be concluded between them and the Community, HAVE ADOPTED THIS REGULATION: Article 1 1. This Regulation provides for the European Environment Agency, hereinafter referred to as \u2018the Agency\u2019, and aims at the setting up of a European Environment Information and Observation Network. 2. To achieve the aims of environmental protection and improvement laid down by the Treaty and by successive Community action programmes on the environment, as well as of sustainable development, the objective of the Agency and of the European Environment Information and Observation Network shall be to provide the Community and the Member States with: (a) objective, reliable and comparable information at European level enabling them to take the requisite measures to protect the environment, to assess the results of such measures and to ensure that the public is properly informed about the state of the environment, and to that end; (b) the necessary technical and scientific support. Article 2 For the purposes of achieving the objective set out in Article 1, the tasks of the Agency shall be: (a) to establish, in cooperation with the Member States, and coordinate the Network referred to in Article 4; in this context, the Agency shall be responsible for the collection, processing and analysis of data, in particular in the fields referred to in Article 3; (b) to provide the Community and the Member States with the objective information necessary for framing and implementing sound and effective environmental policies; to that end, in particular to provide the Commission with the information that it needs to be able to carry out successfully its tasks of identifying, preparing and evaluating measures and legislation in the field of the environment; (c) to assist the monitoring of environmental measures through appropriate support for reporting requirements (including through involvement in the development of questionnaires, the processing of reports from Member States and the distribution of results), in accordance with its multiannual work programme and with the aim of coordinating reporting; (d) to advise individual Member States, upon their request and where this is consistent with the Agency\u2019s annual work programme, on the development, establishment and expansion of their systems for the monitoring of environmental measures, provided such activities do not endanger the fulfilment of the other tasks established by this Article; such advice may also include peer reviews by experts at the specific request of Member States; (e) to record, collate and assess data on the state of the environment, to draw up expert reports on the quality, sensitivity and pressures on the environment within the territory of the Community, to provide uniform assessment criteria for environmental data to be applied in all Member States, to develop further and maintain a reference centre of information on the environment; the Commission shall use this information in its task of ensuring the implementation of Community legislation on the environment; (f) to help ensure that environmental data at European level are comparable and, if necessary, to encourage by appropriate means improved harmonisation of methods of measurement; (g) to promote the incorporation of European environmental information into international environment monitoring programmes such as those established by the United Nations and its specialised agencies; (h) to publish a report on the state of, trends in and prospects for the environment every five years, supplemented by indicator reports focusing upon specific issues; (i) to stimulate the development and application of environmental forecasting techniques so that adequate preventive measures can be taken in good time; (j) to stimulate the development of methods of assessing the cost of damage to the environment and the costs of environmental preventive, protection and restoration policies; (k) to stimulate the exchange of information on the best technologies available for preventing or reducing damage to the environment; (l) to cooperate with the bodies and programmes referred to in Article 15; (m) to ensure the broad dissemination of reliable and comparable environmental information, in particular on the state of the environment, to the general public and, to this end, to promote the use of new telematics technology for this purpose; (n) to support the Commission in the process of exchange of information on the development of environmental assessment methodologies and best practice; (o) to assist the Commission in the diffusion of information on the results of relevant environmental research and in a form which can best assist policy development. Article 3 1. The principal areas of activity of the Agency shall, as far as possible, include all elements enabling it to gather the information making it possible to describe the present and foreseeable state of the environment from the following points of view: (a) the quality of the environment; (b) the pressures on the environment; (c) the sensitivity of the environment; including placing these in the context of sustainable development. 2. The Agency shall furnish information which can be directly used in the implementation of Community environmental policy. Priority shall be given to the following areas of work: (a) air quality and atmospheric emissions; (b) water quality, pollutants and water resources; (c) the state of the soil, of the fauna and flora, and of biotopes; (d) land use and natural resources; (e) waste management; (f) noise emissions; (g) chemical substances which are hazardous for the environment; (h) coastal and marine protection. In particular, transfrontier, plurinational and global phenomena shall be covered. The socioeconomic dimension shall also be taken into account. 3. The Agency may also cooperate in the exchange of information with other bodies, including with the European Network for the Implementation and Enforcement of Environmental Law (IMPEL Network). In its activities the Agency shall avoid duplicating the existing activities of other institutions and bodies. Article 4 1. The Network shall comprise: (a) the main component elements of the national information networks; (b) the national focal points; (c) the topic centres. 2. Member States shall keep the Agency informed of the main component elements of their national environment information networks, especially in the priority areas referred to in Article 3(2), including any institution which in their judgment could contribute to the work of the Agency, taking into account the need to ensure the fullest possible geographical coverage of their territory. Member States shall, as appropriate, cooperate with the Agency and contribute to the work of the European Environment Information and Observation Network in accordance with the work programme of the Agency by collecting, collating and analysing data nationwide. Member States may also join to cooperate in these activities at a transnational level. 3. Member States may in particular designate from among the institutions referred to in paragraph 2 or other organisations established in their territory a \u2018national focal point\u2019 for coordinating and/or transmitting the information to be supplied at national level to the Agency and to the institutions or bodies forming part of the Network, including the topic centres referred to in paragraph 4. 4. Member States may also, by 30 April 1994, identify the institutions or other organisations established in their territory which could be specifically entrusted with the task of cooperating with the Agency as regards certain topics of particular interest. An institution thus identified should be in a position to conclude an agreement with the Agency to act as a topic centre of the Network for specific tasks. These centres shall cooperate with other institutions which form part of the Network. 5. The topic centres shall be designated by the Management Board as defined in Article 8(1), for a period not exceeding the duration of each multiannual work programme as referred to in Article 8(4). Each designation may, however, be renewed. 6. The allocation of specific tasks to the topic centres shall appear in the Agency\u2019s multiannual work programme mentioned in Article 8(4). 7. In the light in particular of the multiannual work programme, the Agency shall periodically re-examine the component elements of the Network as referred to in paragraph 2 and shall make such changes as may be decided on by the Management Board, taking account of any new designations made by the Member States. Article 5 The Agency may agree with the institutions or bodies which form part of the Network, as referred to in Article 4, upon the necessary arrangements, in particular contracts, for successfully carrying out the tasks which it may entrust to them. A Member State may provide, as regards the national institutions or organisations in its territory, that such arrangements with the Agency shall be made in agreement with the national focal point. Article 6 1. Regulation (EC) No 1049/2001 shall apply to documents held by the Agency. 2. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the European Ombudsman or of an action before the Court of Justice of the European Communities, under the conditions laid down in Articles 195 and 230 of the Treaty respectively. Article 7 The Agency shall have legal personality. It shall enjoy in all the Member States the most extensive legal capacity accorded to legal persons under their laws. Article 8 1. The Agency shall have a Management Board consisting of one representative of each Member State and two representatives of the Commission. In addition, there may be one representative of each other country which participates in the Agency, in accordance with the relevant provisions. In addition, the European Parliament shall designate, as members of the Management Board, two scientific personalities particularly qualified in the field of environmental protection, who shall be chosen on the basis of the personal contribution they are likely to make to the Agency\u2019s work. Each member of the Management Board may be represented by an alternate member. 2. The Management Board shall elect its chairman from among its members for a period of three years and shall adopt its rules of procedure. Each member of the Management Board shall have a vote. The Management Board shall elect a bureau to which it may delegate executive decisions, according to the rules that it shall adopt. 3. Decisions of the Management Board shall require for their adoption a two-thirds majority of the members of the Board. 4. The Management Board shall adopt a multiannual work programme based on the priority areas referred to in Article 3(2), using as its basis a draft submitted by the Executive Director referred to in Article 9, after consulting the scientific committee, referred to in Article 10, and receiving the Commission\u2019s opinion. The multiannual work programme shall, without prejudice to the annual Community budgetary procedure, include a multiannual budget estimate. 5. Under the multiannual programme, the Management Board shall each year adopt the Agency\u2019s work programme on the basis of a draft submitted by the Executive Director after consulting the scientific committee and receiving the Commission\u2019s opinion. The programme may be adjusted in the course of the year by the same procedure. 6. The Management Board shall adopt the annual report on the Agency\u2019s activities and forward it by 15 June at the latest to the European Parliament, the Council, the Commission, the Court of Auditors and the Member States. 7. The Agency shall forward annually to the budgetary authority all information relevant to the outcome of the evaluation procedures. Article 9 1. The Agency shall be headed by an Executive Director appointed by the Management Board on a proposal from the Commission for a period of five years, which shall be renewable. The Executive Director shall be the legal representative of the Agency. The Executive Director shall be responsible: (a) for the proper preparation and execution of the decisions and programmes adopted by the Management Board; (b) for the day-to-day administration of the Agency; (c) for the performance of the tasks defined in Articles 12 and 13; (d) for the preparation and publication of the reports specified in Article 2(h); (e) for all staff matters, for the performance of the tasks referred to in Article 8(4) and (5). He shall obtain the opinion of the scientific committee, referred to in Article 10, for the purposes of recruitment of the Agency\u2019s scientific staff. 2. The Executive Director shall be accountable to the Management Board for his activities. Article 10 1. The Management Board and the Executive Director shall be assisted by a scientific committee which shall deliver an opinion where provided for in this Regulation and on any scientific matter concerning the Agency\u2019s activity which the Management Board or the Executive Director may submit to it. The opinions of the scientific committee shall be published. 2. The scientific committee shall be made up of members particularly qualified in the field of the environment, designated by the Management Board for a term of four years renewable once, taking into account, inter alia, the scientific areas which need to be represented in the committee in order to assist the Agency in its areas of activity. It shall function as determined by the rules of procedure provided for in Article 8(2). Article 11 1. Estimates shall be drawn up of all the Agency\u2019s revenue and expenditure for each financial year, which shall correspond to the calendar year, and shall be entered in the Agency\u2019s budget. 2. The revenue and expenditure shown in the budget shall be in balance. 3. The revenue of the Agency shall, without prejudice to other resources, consist of a subsidy from the Community entered in the general budget of the European Communities and of payments for services rendered. 4. The expenditure of the Agency shall include, inter alia, staff remuneration, administrative and infrastructure expenses, operating costs and expenditure relating to contracts concluded with institutions or bodies forming part of the Network and with third parties. Article 12 1. Each year the Management Board, on the basis of a draft drawn up by the Executive Director, shall produce a statement of estimates of revenue and expenditure of the Agency for the following financial year. This statement of estimates, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest. 2. The statement of estimates shall be forwarded by the Commission to the European Parliament and the Council (hereinafter referred to as the budgetary authority) together with the preliminary draft general budget of the European Communities. 3. On the basis of the statement of estimates, the Commission shall enter in the preliminary draft general budget of the European Communities the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty. 4. The budgetary authority shall authorise the appropriations for the subsidy to the Agency. The budgetary authority shall adopt the establishment plan for the Agency. 5. The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Communities. Where appropriate, it shall be adjusted accordingly. 6. The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of the budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks after the date of notification of the project. Article 13 1. The Executive Director shall implement the budget of the Agency. 2. By 1 March at the latest following each financial year, the Agency\u2019s accounting officer shall communicate the provisional accounts to the Commission\u2019s accounting officer together with a report on the budgetary and financial management for that financial year. The Commission\u2019s accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (6). 3. By 31 March at the latest following each financial year, the Commission\u2019s accounting officer shall forward the Agency\u2019s provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and the Council. 4. On receipt of the Court of Auditors\u2019 observations on the Agency\u2019s provisional accounts under Article 129 of Regulation (EC, Euratom) No 1605/2002, the Executive Director shall draw up the Agency\u2019s final accounts under his own responsibility and submit them to the Management Board for an opinion. 5. The Management Board shall deliver an opinion on the Agency\u2019s final accounts. 6. The Executive Director shall, by 1 July at the latest following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board\u2019s opinion. 7. The final accounts shall be published. 8. The Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board. 9. The Executive Director shall submit to the European Parliament, at the latter\u2019s request, all information necessary for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of Regulation (EC, Euratom) No 1605/2002. 10. The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N. Article 14 The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (7) unless such departure is specifically required for the Agency\u2019s operation and the Commission has given its prior consent. Article 15 1. The Agency shall actively seek the cooperation of other Community bodies and programmes, and notably the Joint Research Centre, the Statistical Office of the European Communities (Eurostat) and the Community\u2019s environmental research and development programmes. In particular: (a) cooperation with the Joint Research Centre shall include the tasks set out in Annex I under A; (b) coordination with Eurostat and the statistical programme of the European Communities shall follow the guidelines outlined in Annex I under B. 2. The Agency shall also cooperate actively with other bodies such as the European Space Agency, the Organisation for Economic Cooperation and Development (OECD), the Council of Europe and the International Energy Agency as well as the United Nations and its specialised agencies, particularly the United Nations Environment Programme, the World Meteorological Organisation and the International Atomic Energy Authority. 3. The Agency may cooperate in areas of common interest with those institutions in countries which are not members of the Community which can provide data, information and expertise, methodologies of data collection, analysis and assessment which are of mutual interest and which are necessary for the successful completion of the Agency\u2019s work. 4. The cooperation referred to in paragraphs 1, 2 and 3 must in particular take account of the need to avoid any duplication of effort. Article 16 The Protocol on the Privileges and Immunities of the European Communities shall apply to the Agency. Article 17 The staff of the Agency shall be subject to the Regulations and Rules applicable to officials and other servants of the European Communities. The Agency shall exercise in respect of its staff the powers devolved to the Appointing Authority. The Management Board shall, in agreement with the Commission, adopt the appropriate implementing rules. Article 18 1. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice shall have jurisdiction to give judgment pursuant to an arbitration clause contained in a contract concluded by the Agency. 2. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by the Agency or its servants in the performance of their duties. The Court of Justice shall have jurisdiction in disputes relating to compensation for any such damage. 3. The personal liability of servants towards the Agency shall be governed by the provisions applying to the staff of the Agency. Article 19 The Agency is open to countries which are not members of the Community but which share the concern of the Community and the Member States for the objectives of the Agency under agreements concluded between them and the Community following the procedure in Article 300 of the Treaty. Article 20 Regulation (EEC) No 1210/90, as amended by the Regulations listed in Annex II, is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III. Article 21 This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 23 April 2009. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President P. NE\u010cAS (1) OJ C 162, 25.6.2008, p. 86. (2) Opinion of the European Parliament of 19 February 2008 (not yet published in the Official Journal) and Council Decision of 23 March 2009. (3) OJ L 120, 11.5.1990, p. 1. (4) See Annex II. (5) OJ L 145, 31.5.2001, p. 43. (6) OJ L 248, 16.9.2002, p. 1. (7) OJ L 357, 31.12.2002, p. 72. ANNEX I A. Cooperation with the Joint Research Centre \u2014 Harmonisation of environmental measurement methods (1). \u2014 Intercalibration of instruments (1). \u2014 Standardisation of data formats. \u2014 Development of new environmental measurement methods and instruments. \u2014 Other tasks as agreed between the Executive Director of the Agency and the Director-General of the Joint Research Centre. B. Cooperation with Eurostat 1. The Agency shall use, as far as possible, information collected via the official Community statistical services. That results from the work of Eurostat and the national statistical services in collecting, validating and disseminating social and economic statistics, including national accounts and related information. 2. The statistical programme in the field of the environment shall be agreed between the Executive Director of the Agency and the Director-General of Eurostat and shall be submitted for approval to the Management Board of the Agency and the Statistical Programme Committee. 3. The statistical programme shall be conceived and implemented within the framework established by the international statistical bodies, such as the UN Statistical Commission, the Conference of European Statisticians and the OECD. (1) Cooperation in these areas shall also take account of the work carried out by the Institute for Reference Materials and Measurements. ANNEX II Repealed Regulation with list of its successive amendments (referred to in Article 20) Council Regulation (EEC) No 1210/90 (OJ L 120, 11.5.1990, p. 1). Council Regulation (EC) No 933/1999 (OJ L 117, 5.5.1999, p. 1). Regulation (EC) No 1641/2003 of the European Parliament and of the Council (OJ L 245, 29.9.2003, p. 1). ANNEX III CORRELATION TABLE Regulation (EEC) No 1210/90 This Regulation Article 1(1) Article 1(1) Article 1(2), introductory wording Article 1(2), introductory wording Article 1(2), first indent Article 1(2), point (a) Article 1(2), second indent Article 1(2), point (b) Article 2, introductory wording Article 2, introductory wording Article 2, point (i) Article 2, point (a) Article 2, point (ii), first indent Article 2, point (b) Article 2, point (ii), second indent Article 2, point (c) Article 2, point (ii), third indent Article 2, point (d) Article 2, point (iii) Article 2, point (e) Article 2, point (iv) Article 2, point (f) Article 2, point (v) Article 2, point (g) Article 2, point (vi) Article 2, point (h) Article 2, point (vii) Article 2, point (i) Article 2, point (viii) Article 2, point (j) Article 2, point (ix) Article 2, point (k) Article 2, point (x) Article 2, point (l) Article 2, point (xi) Article 2, point (m) Article 2, point (xii) Article 2, point (n) Article 2, point (xiii) Article 2, point (o) Article 3(1), introductory wording Article 3(1), introductory wording Article 3(1), point (i) Article 3(1), point (a) Article 3(1), point (ii) Article 3(1), point (b) Article 3(1), point (iii) Article 3(1), point (c) Article 3(1), final wording Article 3(1), final wording Article 3(2), first subparagraph Article 3(2), first subparagraph Article 3(2), second subparagraph, introductory wording Article 3(2), second subparagraph, introductory wording Article 3(2), second subparagraph, first indent Article 3(2), second subparagraph, point (a) Article 3(2), second subparagraph, second indent Article 3(2), second subparagraph, point (b) Article 3(2), second subparagraph, third indent Article 3(2), second subparagraph, point (c) Article 3(2), second subparagraph, fourth indent Article 3(2), second subparagraph, point (d) Article 3(2), second subparagraph, fifth indent Article 3(2), second subparagraph, point (e) Article 3(2), second subparagraph, sixth indent Article 3(2), second subparagraph, point (f) Article 3(2), second subparagraph, seventh indent Article 3(2), second subparagraph, point (g) Article 3(2), second subparagraph, eighth indent Article 3(2), second subparagraph, point (h) Article 3(2), third subparagraph Article 3(2), third subparagraph Article 3(2), fourth subparagraph Article 3(2), fourth subparagraph Article 3(3) Article 3(3) Article 4(1), introductory wording Article 4(1), introductory wording Article 4(1), first indent Article 4(1), point (a) Article 4(1), second indent Article 4(1), point (b) Article 4(1), third indent Article 4(1), point (c) Article 4(2), first subparagraph, from \u2018to\u2019 to \u2018networks\u2019 \u2014 Article 4(2), first subparagraph, from \u2018especially\u2019 to \u2018territory\u2019 Article 4(2), first subparagraph, final wording Article 4(2), second subparagraph Article 4(2), first, second and third subparagraphs Article 4(3) Article 4(3) Article 4(4) Article 4(4), first, second and third subparagraphs Article 4(5), first subparagraph \u2014 Article 4(5), second subparagraph Article 4(5) Article 4(6) and (7) Article 4(6) and (7) Article 5 Article 5, first and second subparagraphs Article 6(1) Article 6(1) Article 6(2) \u2014 Article 6(3) Article 6(2) Articles 7 and 8 Articles 7 and 8 Article 9(1), first subparagraph, first sentence Article 9(1), first subparagraph Article 9(1), first subparagraph, second sentence Article 9(1), second subparagraph Article 9(1), first subparagraph, introductory wording Article 9(1), third subparagraph, introductory wording Article 9(1), first subparagraph, first indent Article 9(1), third subparagraph, point (a) Article 9(1), first subparagraph, second indent Article 9(1), third subparagraph, point (b) Article 9(1), first subparagraph, third indent Article 9(1), third subparagraph point (c) Article 9(1), first subparagraph, fourth indent Article 9(1), third subparagraph, point (d) Article 9(1), first subparagraph, fifth indent Article 9(1), third subparagraph, point (e) Article 9(1), second subparagraph Article 9(1), fourth subparagraph Article 9(2) Article 9(2) Article 10 Article 10 Article 11 Article 11 Article 12 Article 12 Article 13 Article 13 Article 14 Article 14 Article 15(1), introductory wording Article 15(1), introductory wording Article 15(1), first indent Article 15(1), point (a) Article 15(1), second indent Article 15(1), point (b) Article 15(2) Article 15(2) Article 15(2a) Article 15(3) Article 15(3) Article 15(4) Article 16 Article 16 Article 17 Article 17 Article 18 Article 18 Article 19 Article 19 Article 20 \u2014 \u2014 Article 20 Article 21 Article 21 Annex Annex I \u2014 Annex II \u2014 Annex III", "summary": "The EU\u2019s environment agency - environmental information and monitoring The EU\u2019s environment agency - environmental information and monitoring Regulation (EC) No 401/2009 - the European Environment Agency and the European Environment Information and Observation Network ACT Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network SUMMARY WHAT DOES THE REGULATION DO? The regulation describes the aims and objectives of the European Environment Agency (EEA) and the European Environment Information and Observation Network (EIONET). This enables them to provide information in support of the formulation of EU environmental policy. KEY POINTS The EEA is an EU agency whose objective is to protect and improve the environment and support sustainable development. It does this by providing objective, reliable and comparable information so that: \u2014 measures are taken to protect the environment; \u2014 the results of such measures are assessed; \u2014 the public is kept informed about the state of the environment; \u2014 EU countries have the necessary technical and scientific support. It has the following principal tasks: \u2014 to collect, process and analyse data to provide the EU with the objective information necessary for effective environmental policies; \u2014 to assist the monitoring of environmental measures; \u2014 to collate, assess and disseminate data on the state of the environment to the general public; \u2014 to ensure that data are comparable Europe-wide; \u2014 to promote the incorporation of EU data into international monitoring programmes such as those of the United Nations; \u2014 to stimulate the development of methods of assessing the cost of damage to the environment and the costs of preventive, protection and restoration policies; \u2014 to stimulate the exchange of information on the best technologies available for preventing or reducing damage to the environment; \u2014 to publish a report on the state of, trends in and prospects for the environment every 5 years. The data covered include: \u2014 air quality and noise pollution; \u2014 water quality; \u2014 the state of the soil and of fauna and flora; \u2014 land use and natural resources; \u2014 waste management \u2014 chemical substances; \u2014 coastal and marine protection; \u2014 climate change and adaptation to climate change. The EEA Board includes 1 representative from each of its member countries, 2 from the European Commission and 2 scientific experts appointed by the European Parliament. An Executive Director is responsible for day-to-day management. The EEA cooperates with other EU and international bodies, such as the EU\u2019s statistical office (Eurostat) and the European Commission's Joint Research Centre, the United Nations Environment Programme and the World Health Organisation. EIONET, coordinated by the EEA, is the EU\u2019s information network on environmental issues. It has representation from all EU countries, as well as Iceland, Liechtenstein, Norway, Switzerland and Turkey. SINCE WHEN DOES THE REGULATION APPLY? As of 10 June 2009. BACKGROUND European Environment Agency website. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 401/2009 10.6.2009 - OJ L 126, 21.5.2009, pp. 13-22 last update 22.09.2015"}
{"article": "22.12.2009 EN Official Journal of the European Union L 342/1 REGULATION (EC) No 1221/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission Decisions 2001/681/EC and 2006/193/EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Article 2 of the Treaty provides that the Community is to have among its tasks the promotion of sustainable growth throughout the Community. (2) Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (4) identifies the improvement of collaboration and partnership with enterprises as a strategic approach to meeting environmental objectives. Voluntary commitments are an essential part thereof. Encouraging wider participation in the Community's eco-management and audit scheme (EMAS) and the development of initiatives to encourage organisations to publish rigorous and independently verified environmental or sustainable development performance reports is regarded as necessary in this context. (3) The Commission Communication of 30 April 2007 on the Mid-term review of the Sixth Community Environment Action Programme recognises that there is a need to improve the functioning of the voluntary instruments that have been designed for industry and that those instruments have a great potential but have not been fully developed. It calls upon the Commission to revise the instruments in order to promote their participation and reduce the administrative burden in their management. (4) The Commission Communication of 16 July 2008 on the Sustainable Consumption and Production and Sustainable Industrial Policy Action Plan recognises that EMAS helps organisations to optimise their production processes, reducing environmental impacts and making more effective use of resources. (5) For the purpose of promoting a coherent approach between the legislative instruments developed at Community level in the field of environmental protection, the Commission and the Member States should consider how registration under EMAS may be taken into account in the development of legislation or used as a tool in the enforcement of legislation. They should also, in order to raise the appeal of EMAS for organisations, take account of EMAS in their procurement policies and, where appropriate, refer to EMAS or equivalent environmental management systems as contract performance conditions for works and service. (6) Article 15 of Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (5) provides that the Commission is to review EMAS in the light of the experience gained during its operation and propose appropriate amendments to the European Parliament and the Council. (7) Application of environmental management schemes, including EMAS as set out in Regulation (EC) No 761/2001, demonstrated their effectiveness in promoting improvements of the environmental performance of organisations. There is, however, a need to increase the number of organisations participating in the scheme in order to achieve a better overall impact of environmental improvements. To this effect, the experience gathered from the implementation of that Regulation should be used to enhance the ability of EMAS to bring about an improvement in the overall environmental performance of organisations. (8) Organisations should be encouraged to participate in EMAS on a voluntary basis and may gain added value in terms of regulatory control, cost savings and public image provided that they are able to demonstrate an improvement of their environmental performance. (9) EMAS should be made available to all organisations, in and outside the Community, whose activities have an environmental impact. EMAS should provide a means for those organisations to manage that impact and to improve their overall environmental performance. (10) Organisations, in particular small organisations, should be encouraged to participate in EMAS. Their participation should be promoted by facilitating access to information, to existing support funds and to public institutions and by establishing or promoting technical assistance measures. (11) Organisations which implement other environmental management systems and want to move to EMAS should be able to do so as easily as possible. Links with other environmental management schemes should be considered. (12) Organisations with sites located in one or more Member States should be able to register all or a number of those sites under one single registration. (13) The mechanism for establishing an organisation's compliance with all applicable legal requirements relating to the environment should be strengthened in order to enhance the credibility of EMAS and, in particular, to enable Member States to reduce the administrative burden of registered organisations by way of deregulation or regulatory relief. (14) The process of implementation of EMAS should include involvement of employees and workers of the organisation as this increases job satisfaction, as well as knowledge of environmental issues which can be replicated in and outside the work environment. (15) The EMAS logo should be an appealing communication and marketing tool for organisations, which raises the awareness of buyers and other stakeholders to EMAS. Rules for the use of the EMAS logo should be simplified by the use of one single logo and existing restrictions should be removed save for those relating to the product and packaging. There should be no confusion with environmental product labels. (16) Costs and fees for registration under EMAS should be reasonable and proportionate to the size of the organisation and the work to be done by the Competent Bodies. Without prejudice to the rules of the Treaty on State aid, exemptions or reductions of fees should be considered for small organisations. (17) Organisations should produce and make publicly available periodic environmental statements providing the public and other interested parties with information on their compliance with applicable legal requirements relating to the environment and their environmental performance. (18) In order to ensure relevance and comparability of the information, reporting on the organisations\u2019 environmental performance should be on the basis of generic and sector-specific performance indicators focusing on key environmental areas at the process and product level using appropriate benchmarks and scales. This should help organisations compare their environmental performance both over different reporting periods and with the environmental performance of other organisations. (19) Reference documents including best environmental management practice and environmental performance indicators for specific sectors should be developed through information exchange and collaboration between Member States. Those documents should help organisations better focus on the most important environmental aspects in a given sector. (20) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (6) organises accreditation at the national and European levels and sets the overall framework for accreditation. This Regulation should complement those rules in so far as necessary, while taking into account the specific features of EMAS such as the need to ensure a high level of credibility towards stakeholders, especially Member States and, where appropriate, should set more specific rules. The EMAS provisions should ensure and steadily improve the competence of environmental verifiers by providing for an independent and neutral accreditation or licensing system, training and an appropriate supervision of their activities and thus guarantee the transparency and credibility of organisations participating in EMAS. (21) When a Member State decides not to use accreditation for EMAS, Article 5(2) of Regulation (EC) No 765/2008 should apply. (22) Promotion and support activities should be undertaken by both the Member States and the Commission. (23) Without prejudice to the rules of the Treaty on State aid, incentives should be given by Member States to registered organisations such as access to funding or tax incentives in the framework of schemes supporting environmental performance of industry, provided that organisations are able to demonstrate an improvement of their environmental performance. (24) Member States and the Commission should develop and implement specific measures aimed at greater participation in EMAS by organisations, in particular small organisations. (25) With the aim of ensuring a harmonised application of this Regulation, the Commission should produce sectoral reference documents in the area covered by this Regulation following a priority programme. (26) This Regulation should be revised, if appropriate, within five years of its entry into force in the light of experience gained. (27) This Regulation replaces Regulation (EC) No 761/2001 which should therefore be repealed. (28) Given that useful elements of Commission Recommendation 2001/680/EC of 7 September 2001 on guidance for the implementation of Regulation (EC) No 761/2001 of the European Parliament and of the Council allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (7) and of Commission Recommendation 2003/532/EC of 10 July 2003 on guidance for the implementation of Regulation (EC) No 761/2001 of the European Parliament and of the Council allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) concerning the selection and use of environmental performance indicators (8) are included in this Regulation, those acts should no longer be used as they are superseded by this Regulation. (29) Since the objectives of this Regulation, namely to create a single credible scheme and avoid the establishment of different national schemes, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (30) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9). (31) In particular the Commission should be empowered to establish procedures for the peer evaluation of Competent Bodies, to develop sectoral reference documents, to recognise existing environmental management systems, or parts thereof, as complying with corresponding requirements of this Regulation and to amend Annexes I to VIII. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (32) Since a period of time is required to ensure that the framework for the proper functioning of this Regulation is in place, Member States should have a period of 12 months following the date of entry into force of this Regulation to modify the procedures followed by Accreditation Bodies and Competent Bodies under the corresponding provisions of this Regulation. Within that 12-month period, Accreditation Bodies and Competent Bodies should be entitled to continue to apply the procedures established under Regulation (EC) No 761/2001, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Objective A Community eco-management and audit scheme, hereinafter referred to as \u2018EMAS\u2019, is hereby established, allowing voluntary participation by organisations located inside or outside the Community. The objective of EMAS, as an important instrument of the Sustainable Consumption and Production and Sustainable Industrial Policy Action Plan, is to promote continuous improvements in the environmental performance of organisations by the establishment and implementation of environmental management systems by organisations, the systematic, objective and periodic evaluation of the performance of such systems, the provision of information on environmental performance, an open dialogue with the public and other interested parties and the active involvement of employees in organisations and appropriate training. Article 2 Definitions For the purposes of this Regulation the following definitions shall apply: 1. \u2018environmental policy\u2019 means the overall intentions and direction of an organisation relating to its environmental performance as formally expressed by top management including compliance with all applicable legal requirements relating to the environment and also a commitment to continuous improvement of environmental performance. It provides a framework for action and for the setting of environmental objectives and targets; 2. \u2018environmental performance\u2019 means the measurable results of an organisation's management of its environmental aspects; 3. \u2018legal compliance\u2019 means full implementation of applicable legal requirements, including permit conditions, relating to the environment; 4. \u2018environmental aspect\u2019 means an element of an organisation's activities, products or services that has or can have an impact on the environment; 5. \u2018significant environmental aspect\u2019 means an environmental aspect that has or can have a significant environmental impact; 6. \u2018direct environmental aspect\u2019 means an environmental aspect associated with activities, products and services of the organisation itself over which it has direct management control; 7. \u2018indirect environmental aspect\u2019 means an environmental aspect which can result from the interaction of an organisation with third parties and which can to a reasonable degree be influenced by an organisation; 8. \u2018environmental impact\u2019 means any change to the environment, whether adverse or beneficial, wholly or partially resulting from an organisation's activities, products or services; 9. \u2018environmental review\u2019 means an initial comprehensive analysis of environmental aspects, environmental impacts and environmental performance related to an organisation's activities, products and services; 10. \u2018environmental programme\u2019 means a description of the measures, responsibilities and means taken or envisaged to achieve environmental objectives and targets and the deadlines for achieving the environmental objectives and targets; 11. \u2018environmental objective\u2019 means an overall environmental goal, arising from the environmental policy, that an organisation sets itself to achieve, and which is quantified where practicable; 12. \u2018environmental target\u2019 means a detailed performance requirement, arising from the environmental objectives, applicable to an organisation or parts thereof, and that needs to be set and met in order to achieve those objectives; 13. \u2018environmental management system\u2019 means the part of the overall management system that includes the organisational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy and managing the environmental aspects; 14. \u2018best environmental management practice\u2019 means the most effective way to implement the environmental management system by organisations in a relevant sector and that can result in best environmental performance under given economic and technical conditions; 15. \u2018substantial change\u2019 means any change in an organisation's operation, structure, administration, processes, activities, products or services that has or can have a significant impact on an organisation's environmental management system, the environment or human health; 16. \u2018internal environmental audit\u2019 means a systematic, documented, periodic and objective evaluation of the environmental performance of an organisation, management system and processes designed to protect the environment; 17. \u2018auditor\u2019 means an individual or group of individuals, belonging to an organisation itself or a natural or legal person external to that organisation, acting on behalf of that organisation, carrying out an assessment of, in particular, the environmental management system in place and determining conformity with the organisation's environmental policy and programme, including compliance with the applicable legal requirements relating to the environment; 18. \u2018environmental statement\u2019 means the comprehensive information to the public and other interested parties regarding an organisation's: (a) structure and activities; (b) environmental policy and environmental management system; (c) environmental aspects and impacts; (d) environmental programme, objectives and targets; (e) environmental performance and compliance with applicable legal obligations relating to the environment as set out in Annex IV; 19. \u2018updated environmental statement\u2019 means the comprehensive information to the public and other interested parties containing updates of the last validated environmental statement, only with regard to an organisation's environmental performance and compliance with applicable legal obligations relating to the environment as set out in Annex IV; 20. \u2018environmental verifier\u2019 means: (a) a conformity assessment body as defined in Regulation (EC) No 765/2008 or any association or group of such bodies, which has obtained accreditation in accordance with this Regulation; or (b) any natural or legal person, or any association or group of such persons, which has obtained a licence to carry out verification and validation in accordance with this Regulation; 21. \u2018organisation\u2019 means a company, corporation, firm, enterprise, authority or institution, located inside or outside the Community, or part or combination thereof, whether incorporated or not, public or private, which has its own functions and administration; 22. \u2018site\u2019 means a distinct geographic location under the management control of an organisation covering activities, products and services, including all infrastructure, equipment and materials; a site is the smallest entity to be considered for registration; 23. \u2018cluster\u2019 means a group of independent organisations related to each other by geographical proximity or business activities jointly implementing the environmental management system; 24. \u2018verification\u2019 means the conformity assessment process carried out by an environmental verifier to demonstrate whether an organisation's environmental review, environmental policy, environmental management system and internal environmental audit and its implementation fulfils the requirements of this Regulation; 25. \u2018validation\u2019 means the confirmation by the environmental verifier who carried out the verification, that the information and data in an organisation's environmental statement and updated environmental statement are reliable, credible and correct and meet the requirements of this Regulation; 26. \u2018enforcement authorities\u2019 means the relevant competent authorities as identified by the Member States to detect, prevent and investigate breaches of applicable legal requirements relating to the environment and, where required, take enforcement action; 27. \u2018environmental performance indicator\u2019 means a specific expression that allows measurement of an organisation's environmental performance; 28. \u2018small organisations\u2019 means: (a) micro, small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (10); or (b) local authorities governing less than 10 000 inhabitants or other public authorities employing fewer than 250 persons and having an annual budget not exceeding EUR 50 million, or an annual balance sheet not exceeding EUR 43 million, including all of the following: (i) government or other public administrations, or public advisory bodies at national, regional or local level; (ii) natural or legal persons performing public administrative functions under national law, including specific duties, activities or services in relation to the environment; and (iii) natural or legal persons having public responsibilities or functions, or providing public services, relating to the environment under the control of a body or person referred to in point (b); 29. \u2018corporate registration\u2019 means a single registration of all or some sites of an organisation with sites located in one or more Member States or third countries; 30. \u2018Accreditation Body\u2019 means a national accreditation body appointed pursuant to Article 4 of Regulation (EC) No 765/2008 which is responsible for the accreditation and supervision of environmental verifiers; 31. \u2018Licensing Body\u2019 means a body appointed in accordance with Article 5(2) of Regulation (EC) No 765/2008 which is responsible for issuing licences to, and for supervising, environmental verifiers. CHAPTER II REGISTRATION OF ORGANISATIONS Article 3 Determination of the Competent Body 1. Applications for registration from organisations in a Member State shall be made to a Competent Body in that Member State. 2. An organisation with sites located in one or more Member States or third countries may apply for one single corporate registration of all or some of those sites. Applications for a single corporate registration shall be made to a Competent Body of the Member State where the organisation's headquarters or management centre designated for the purpose of this paragraph is located. 3. Applications for registration from organisations outside the Community, including corporate registration consisting only of sites located outside the Community, shall be made to any Competent Body in those Member States that provide for the registration of organisations from outside the Community in accordance with the second subparagraph of Article 11(1). Those organisations shall ensure that the environmental verifier which will carry out the verification and validate the environmental management system of the organisation is accredited or licensed in the Member State where the organisation applies for registration. Article 4 Preparation for registration 1. Organisations wishing to be registered for the first time shall: (a) carry out an environmental review of all environmental aspects of the organisation in accordance with the requirements set out in Annex I and in point A.3.1 of Annex II; (b) in the light of the results of the environmental review, develop and implement an environmental management system covering all the requirements referred to in Annex II, and, where available, taking into account the best environmental management practice for the relevant sector referred to in Article 46(1)(a); (c) carry out an internal audit in accordance with the requirements set out in point A.5.5 of Annex II and Annex III; (d) prepare an environmental statement, in accordance with Annex IV. Where sectoral reference documents as referred to in Article 46 are available for the specific sector, the assessment of the organisation's environmental performance shall take into account the relevant document. 2. Organisations may use the assistance referred to in Article 32 that is available in the Member State where the organisation applies for registration. 3. Organisations which have a certified environmental management system, recognised in accordance with Article 45(4), shall not be obliged to carry out those parts which have been recognised as equivalent to this Regulation. 4. Organisations shall provide material or documentary evidence showing that the organisation complies with all applicable legal requirements relating to the environment. Organisations may request information from the competent enforcement authority or authorities in accordance with Article 32 or the environmental verifier. Organisations outside the Community shall also make reference to the legal requirements relating to the environment applicable to similar organisations in the Member States where they intend to submit an application. Where sectoral reference documents as referred to in Article 46 are available for the specific sector, the assessment of the organisation's environmental performance shall be made with reference to the relevant document. 5. The initial environmental review, the environment management system, the audit procedure and its implementation shall be verified by an accredited or licensed environmental verifier and the environmental statement shall be validated by that verifier. Article 5 Application for registration 1. Any organisation meeting requirements set out in Article 4 may apply for registration. 2. The application for registration shall be made to the Competent Body determined in accordance with Article 3 and shall include the following: (a) the validated environmental statement in electronic or printed form; (b) the declaration as referred to in Article 25(9), signed by the environmental verifier which validated the environmental statement; (c) a completed form, which includes at least the minimum information on as set out in Annex VI; (d) evidence of payment of applicable fees, if applicable. 3. The application shall be written in (one of) the official language(s) of the Member State in which the organisation applies for registration. CHAPTER III OBLIGATIONS OF REGISTERED ORGANISATIONS Article 6 Renewal of EMAS registration 1. A registered organisation shall at least on a three-yearly basis: (a) have the full environmental management system and audit programme and its implementation verified; (b) prepare the environmental statement in accordance with the requirements set out in Annex IV and have it validated by an environmental verifier; (c) forward the validated environmental statement to the Competent Body; (d) forward to the Competent Body a completed form, which includes at least the minimum information set out in Annex VI; (e) pay a fee for the renewal of the registration to the Competent Body, if applicable. 2. Without prejudice to paragraph 1, in the intervening years, a registered organisation shall: (a) in accordance with the audit programme, carry out an internal audit of its environmental performance and compliance with applicable legal requirements relating to the environment in accordance with Annex III; (b) prepare an updated environmental statement in accordance with the requirements laid down in Annex IV, and have it validated by an environmental verifier; (c) forward the validated updated environmental statement to the Competent Body; (d) forward to the Competent Body a completed form, which includes at least the minimum information set out in Annex VI; (e) pay a fee for the maintenance of the registration to the Competent Body, if applicable. 3. Registered organisations shall make their environmental statement and updated environmental statement accessible to the public within one month of registration and one month after the renewal of the registration is completed. Registered organisations may satisfy that requirement by providing access to the environmental statement and the updated environmental statement upon request or by creating links to Internet sites where those statements can be accessed. Registered organisations shall specify the way in which they provide public access in the form set out in Annex VI. Article 7 Derogation for small organisations 1. Competent Bodies shall, upon request of a small organisation, extend for that organisation the three-yearly frequency referred to in Article 6(1) up to four years or the annual frequency referred to in Article 6(2) up to two years, provided that the environmental verifier that has verified the organisation confirms that all the following conditions are met: (a) no significant environmental risks are present; (b) the organisation has no substantial changes planned as defined in Article 8, and (c) there exist no significant local environmental problems that the organisation contributes to. To submit the request referred to in the first subparagraph, the organisation may use the form set out in Annex VI. 2. The Competent Body shall refuse the request if the conditions set out in paragraph 1 are not met. It shall communicate a reasoned justification to the organisation. 3. Organisations benefiting from an extension of up to two years, as referred to in paragraph 1, shall forward the non-validated updated environmental statement to the Competent Body each year that they are exempt from the obligation to have a validated updated environmental statement. Article 8 Substantial changes 1. Where a registered organisation plans to introduce substantial changes, the organisation shall carry out an environmental review of these changes, including their environmental aspects and impacts. 2. Following the environmental review of changes, the organisation shall update the initial environmental review, modify the environmental policy, the environmental programme and the environmental management system and revise and update the entire environmental statement accordingly. 3. All documents modified and updated pursuant to paragraph 2 shall be verified and validated within six months. 4. After validation, the organisation shall submit changes to the Competent Body using the form set out in Annex VI and make the changes publicly available. Article 9 Internal environmental audit 1. A registered organisation shall establish an audit programme that ensures that over a period of time, not exceeding three years or four years if the derogation provided for in Article 7 applies, all activities in the organisation are subject to an internal environmental audit in accordance with the requirements set out in Annex III. 2. The audit shall be carried out by auditors who possess, individually or collectively, the competence necessary for carrying out these tasks and are sufficiently independent of the activities they audit to make an objective judgment. 3. The organisation's environmental auditing programme shall define the objectives of each audit or audit cycle including the audit frequency for each activity. 4. A written audit report shall be prepared by the auditors at the end of each audit and audit cycle. 5. The auditor shall communicate the findings and conclusions of the audit to the organisation. 6. Following the audit process, the organisation shall prepare and implement an appropriate action plan. 7. The organisation shall put in place appropriate mechanisms that ensure that the audit results are followed up. Article 10 Use of the EMAS logo 1. Without prejudice to Article 35(2), the EMAS logo set out in Annex V may be used only by registered organisations and only as long as their registration is valid. The logo shall always bear the registration number of the organisation. 2. The EMAS logo shall only be used in accordance with the technical specifications set out in Annex V. 3. In case an organisation chooses, in accordance with Article 3(2), not to include all its sites in the corporate registration, it shall ensure that in its communications with the public and in its use of the EMAS logo it is clear which sites are covered by the registration. 4. The EMAS logo shall not be used: (a) on products or their packaging; or (b) in conjunction with comparative claims concerning other activities and services or in a way that may create confusion with environmental product labels. 5. Any environmental information published by a registered organisation may bear the EMAS logo provided such information makes reference to the organisation's latest environmental statement or updated environmental statement from which it was drawn and it has been validated by an environmental verifier as being: (a) accurate; (b) substantiated and verifiable; (c) relevant and used in an appropriate context or setting; (d) representative of the overall environmental performance of the organisation; (e) unlikely to result in misinterpretation; and (f) significant in relation to the overall environmental impact. CHAPTER IV RULES APPLICABLE TO COMPETENT BODIES Article 11 Designation and role of Competent Bodies 1. Member States shall designate Competent Bodies, which shall be responsible for the registration of organisations located in the Community in accordance with this Regulation. Member States may provide that the Competent Bodies they designate provide for and shall be responsible for the registration of organisations located outside the Community in accordance with this Regulation. The Competent Bodies shall control the entry and maintenance of organisations on the register, including suspension and deletion. 2. The Competent Bodies may be national, regional or local. 3. The composition of the Competent Bodies shall guarantee their independence and neutrality. 4. The Competent Bodies shall have the appropriate resources, both financial and in terms of personnel, for the proper performance of their tasks. 5. The Competent Bodies shall apply this Regulation in a consistent manner and shall participate in regular peer evaluation as set out in Article 17. Article 12 Obligations concerning the registration process 1. Competent Bodies shall establish procedures for the registration of organisations. They shall in particular establish rules for: (a) considering observations from interested parties, including Accreditation and Licensing Bodies and competent enforcement authorities and the organisations\u2019 representative bodies, concerning applicant or registered organisations; (b) refusal of registration, suspension or deletion of organisations, and (c) resolution of appeals and complaints made against their decisions. 2. Competent Bodies shall establish and maintain a register of organisations registered in their Member States, including information as to how their environmental statement or updated environmental statement can be obtained, and, in the case of changes, update that register on a monthly basis. The register shall be publicly available on a website. 3. Competent Bodies shall each month, directly or via the national authorities as decided by the Member States concerned, communicate changes in the register referred to in paragraph 2 to the Commission. Article 13 Registration of organisations 1. Competent Bodies shall consider applications for registration of organisations in accordance with the procedures established to this end. 2. Where an organisation applies for registration, the Competent Body shall register that organisation and give it a registration number if all the following conditions are fulfilled: (a) the Competent Body has received an application for registration, which includes all the documents referred to in Article 5(2)(a) to (d); (b) the Competent Body has checked that the verification and validation have been carried out in accordance with Articles 25, 26 and 27; (c) the Competent Body is satisfied on the basis of material evidence received, for example through a written report from the competent enforcement authority that there is no evidence of breach of applicable legal requirements relating to the environment; (d) there are no relevant complaints from interested parties or complaints have been positively solved; (e) the Competent Body is satisfied on the basis of evidence received that the organisation meets all the requirements of this Regulation; and (f) the Competent Body has received a registration fee, if applicable. 3. The Competent Body shall inform the organisation that it has been registered and provide the organisation with its registration number and the EMAS logo. 4. If a Competent Body concludes that an applicant organisation does not comply with the requirements set out in paragraph 2, it shall refuse to register that organisation and communicate a reasoned justification to the organisation. 5. If a Competent Body receives a written supervision report from the Accreditation or Licensing Body which provides evidence that the activities of the environmental verifier were not performed adequately enough to ensure that the requirements of this Regulation are met by the applicant organisation, it shall refuse to register that organisation. The Competent Body shall invite the organisation to submit a new application for registration. 6. In order to obtain the necessary evidence for taking a decision on refusal of registration of organisations, the Competent Body shall consult the concerned parties including the organisation. Article 14 Renewal of the organisation's registration 1. A Competent Body shall renew the registration of the organisation if all the following conditions are fulfilled: (a) the Competent Body has received a validated environmental statement as referred to in Article 6(1)(c), a validated updated environmental statement as referred to in Article 6(2)(c) or a non-validated updated environmental statement as referred to in Article 7(3); (b) the Competent Body has received a completed form, which includes at least the minimum information set out in Annex VI, as referred to in Article 6(1)(d) and in Article 6(2)(d); (c) the Competent Body has no evidence that the verification and validation have not been carried out in accordance with Articles 25, 26 and 27; (d) the Competent Body has no evidence of non-compliance by the organisation with applicable legal requirements relating to the environment; (e) there are no relevant complaints from interested parties or complaints have been positively solved; (f) the Competent Body is satisfied on the basis of evidence received that the organisation meets all the requirements of this Regulation; and (g) the Competent Body has received a fee for renewal of the registration, if applicable. 2. The Competent Body shall inform the organisation that its registration has been renewed. Article 15 Suspension or deletion of organisations from the register 1. Where a Competent Body believes that a registered organisation does not comply with this Regulation, it shall give the organisation the opportunity to submit its views on the matter. Should the organisation fail to provide a satisfactory response it shall be deleted or suspended from the register. 2. Where a Competent Body receives a written supervision report from the Accreditation or Licensing Body which provides evidence that the activities of the environmental verifier were not performed adequately enough to ensure that the requirements of this Regulation are met by the registered organisation, registration shall be suspended. 3. A registered organisation shall be suspended or deleted from the register, as appropriate, if it fails to submit to a Competent Body, within two months of being required to do so, any of the following: (a) the validated environmental statement, an updated environmental statement or the signed declaration referred to in Article 25(9); (b) a form which includes at least the minimum information set out in Annex VI from the organisation. 4. If a Competent Body is informed through a written report by the competent enforcement authority of a breach by the organisation of any applicable legal requirements relating to the environment, it shall suspend or delete the reference to that organisation from the register as appropriate. 5. In case a Competent Body decides to suspend or delete a registration it shall take into account at least the following: (a) the environmental effect of the non-compliance by the organisation with the requirements of this Regulation; (b) the foreseeability of the non-compliance by the organisation with the requirements of this Regulation or the circumstances leading to it; (c) previous instances of non-compliance with the requirements of this Regulation by the organisation; and (d) the specific circumstances of the organisation. 6. In order to obtain the necessary evidence for taking its decision on suspension or deletion of organisations from the register, the Competent Body shall consult the concerned parties including the organisation. 7. Where the Competent Body has received evidence, other than by means of a written supervision report of the Accreditation or Licensing Body, that activities of the environmental verifier were not performed adequately enough to ensure that the requirements of this Regulation are met by the organisation, it shall consult the Accreditation or Licensing Body supervising the environmental verifier. 8. The Competent Body shall give reasons for any measures taken. 9. The Competent Body shall provide appropriate information to the organisation concerning the consultations with the concerned parties. 10. Suspension of an organisation from the register shall be lifted if the Competent Body has received satisfactory information that the organisation is in compliance with the requirements of this Regulation. Article 16 Forum of Competent Bodies 1. A Forum of Competent Bodies from all Member States, hereinafter referred to as \u2018the Forum of Competent Bodies\u2019, shall be set up by the Competent Bodies and meet at least once per year in the presence of a representative of the Commission. The Forum of Competent Bodies shall adopt its rules of procedure. 2. Competent Bodies of each Member State shall participate in the Forum of Competent Bodies. Where several Competent Bodies are established within one Member State, appropriate measures shall be taken to ensure that all of them are informed about the activities of the Forum of Competent Bodies. 3. The Forum of Competent Bodies shall develop guidance to ensure the consistency of procedures relating to the registration of organisations in accordance with this Regulation, including renewal of registration and suspension and deletion of organisations from the register both inside and outside the Community. The Forum of Competent Bodies shall transmit to the Commission the guidance documents and documents referring to the peer evaluation. 4. Guidance documents referring to harmonisation procedures approved by the Forum of Competent Bodies shall be proposed as appropriate by the Commission for adoption in accordance with the regulatory procedure with scrutiny referred to in Article 49(3). Those documents shall be made publicly available. Article 17 Peer evaluation of Competent Bodies 1. A peer evaluation shall be organised by the Forum of Competent Bodies to assess conformity of the registration system of every Competent Body with this Regulation and to develop a harmonised approach to the application of the rules relating to registration. 2. The peer evaluation shall be carried out on a regular basis and at least every four years, and shall include an assessment of the rules and procedures set out in Articles 12, 13 and 15. All Competent Bodies shall participate in the peer evaluation. 3. The Commission shall establish procedures for carrying out the peer evaluation, including appropriate appeals procedures against decisions taken as a result of the peer evaluation. Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3). 4. Procedures referred to in paragraph 3 shall be established before the first peer evaluation takes place. 5. The Forum of Competent Bodies shall transmit a regular report of the peer evaluation to the Commission and the Committee established under Article 49(1). That report shall be made publicly available after approval by the Forum of Competent Bodies and the Committee referred to in the first subparagraph. CHAPTER V ENVIRONMENTAL VERIFIERS Article 18 Tasks of Environmental verifiers 1. Environmental verifiers shall assess whether an organisation's environmental review, environmental policy, management system, audit procedures and their implementation comply with the requirements of this Regulation. 2. Environmental verifiers shall verify the following: (a) compliance of the organisation with all the requirements of this Regulation with respect to the initial environmental review, environmental management system, environmental audit and its results and the environmental statement or updated environmental statement; (b) compliance of the organisation with applicable Community, national, regional and local legal requirements relating to the environment; (c) the organisation's continuous improvement of environmental performance; and (d) the reliability, credibility and correctness of the data and information in the following documents: (i) the environmental statement; (ii) the updated environmental statement; (iii) any environmental information to be validated. 3. Environmental verifiers shall, in particular, verify the appropriateness of the initial environmental review, or audit or other procedures carried out by the organisation, without unnecessarily duplicating those procedures. 4. Environmental verifiers shall verify whether the results of the internal audit are reliable. Where appropriate, they shall use spot-checks for that purpose. 5. At the time of the verification for the preparation for registration of an organisation, the environmental verifier shall check that at least the following requirements are met by that organisation: (a) a fully operational environmental management system in accordance with Annex II is in place; (b) a fully planned audit programme is in place and has begun in accordance with Annex III so that at least the most significant environmental impacts have been covered; (c) the management review referred to in Part A of Annex II is completed; and (d) an environmental statement is prepared in accordance with Annex IV and sectoral reference documents were taken into account, where available. 6. For the purposes of the verification for the renewal of registration referred to in Article 6(1), the environmental verifier shall check that the following requirements are met by the organisation: (a) the organisation has a fully operational environmental management system in accordance with Annex II; (b) the organisation has a fully operational planned audit programme, with at least one audit cycle completed in accordance with Annex III; (c) the organisation has completed one management review; and (d) the organisation has prepared an environmental statement in accordance with Annex IV and sectoral reference documents were taken into account, where available. 7. For the purposes of the verification for renewal of registration referred to in Article 6(2), the environmental verifier shall check that at least the following requirements are met by the organisation: (a) the organisation has carried out an internal audit of the environmental performance and the compliance with applicable legal requirements relating to the environment in accordance with Annex III; (b) the organisation demonstrates ongoing compliance with applicable legal requirements relating to the environment and continuous improvement of its environmental performance; and (c) the organisation has prepared an updated environmental statement in accordance with Annex IV and, where available, sectoral reference documents were taken into account. Article 19 Frequency of verification 1. The environmental verifier shall design, in consultation with the organisation, a programme that ensures that all elements required for registration and renewal of registration referred to in Articles 4, 5 and 6 are verified. 2. The environmental verifier shall at intervals not exceeding 12 months validate any updated information in the environmental statement or updated environmental statement. Where relevant, the derogation provided for in Article 7 shall apply. Article 20 Requirements for environmental verifiers 1. In order to obtain accreditation or a licence in accordance with this Regulation, a candidate environmental verifier shall introduce a request with the Accreditation or Licensing Body from which it seeks accreditation or a licence. That request shall specify the scope of the requested accreditation or licence by reference to the classification of economic activities as set out in Regulation (EC) No 1893/2006 (11). 2. The environmental verifier shall provide to the Accreditation or Licensing Body appropriate evidence of its competence, including knowledge, relevant experience and technical capacities relevant to the scope of the requested accreditation or licence in the following fields: (a) this Regulation; (b) the general functioning of environmental management systems; (c) relevant sectoral reference documents issued by the Commission, under Article 46, for the application of this Regulation; (d) the legislative, regulatory and administrative requirements relevant to the activity subject to verification and validation; (e) environmental aspects and impacts including the environmental dimension of sustainable development; (f) the technical aspects, relevant to environmental issues, of the activity subject to verification and validation; (g) the general functioning of the activity subject to verification and validation in order to assess the appropriateness of the management system, in relation to the interaction of the organisation and its products, services and operations with the environment including at least the following: (i) technologies employed by the organisation; (ii) terminology and tools deployed in the activities; (iii) operational activities and characteristics of their interaction with the environment; (iv) methodologies for the evaluation of significant environmental aspects; (v) pollution control and mitigation technologies; (h) environmental auditing requirements and methodology including the ability to undertake effective verification audits of an environmental management system, identification of appropriate audit findings and conclusions and preparation and presentation of audits reports, in oral and written forms, to provide a clear record of the verification audit; (i) information audit, the environmental statement and the updated environmental statement in relation to data management, data storage and manipulation, presentation of data in written and graphical format for the appreciation of potential data errors, use of assumptions and estimates; (j) the environmental dimension of products and services including the environmental aspects and environmental performance during the usage and post-use, and the integrity of data provided for environmental decision making. 3. The environmental verifier shall be required to demonstrate a continuing professional development in the fields of competence set out in paragraph 2 and to maintain such development for assessment by the Accreditation or Licensing Body. 4. The environmental verifier shall be an external third party, independent, in particular of the organisation's auditor or consultant, impartial and objective in performing its activities. 5. The environmental verifier shall ensure that it is free from any commercial, financial or other pressures which might influence its judgment or endanger trust in its independence of judgment and integrity in relation to the verification activities. The environmental verifier shall ensure compliance with any rules applicable in this respect. 6. The environmental verifier shall have documented methods and procedures, including quality control mechanisms and confidentiality provisions, to comply with the verification and validation requirements of this Regulation. 7. Where an organisation acts as environmental verifier, it shall keep an organisation chart detailing structures and responsibilities within the organisation and a statement of legal status, ownership and funding sources. That organisation chart shall be made available on request. 8. Compliance with these requirements shall be ensured through the assessment carried out prior to the accreditation or licensing and through the supervision by the Accreditation or Licensing Body. Article 21 Additional requirements for environmental verifiers which are natural persons and performing verification and validation activities individually Natural persons acting as environmental verifiers and performing verification and validation individually shall have, in addition to complying with the requirements set out in Article 20: (a) all the necessary competence to perform verification and validation activities in their licensed fields; (b) a limited scope of the licence dependent on their personal competence. Article 22 Additional requirements for environmental verifiers active in third countries 1. Where an environmental verifier intends to carry out verification and validation activities in third countries, it shall seek accreditation or licence for specific third countries. 2. In order to obtain accreditation or a licence for a third country, the environmental verifier shall meet, in addition to the requirements set out in Articles 20 and 21, the following requirements: (a) knowledge and understanding of the legislative, regulatory and administrative requirements relating to the environment in the third country for which accreditation or a licence is sought; (b) knowledge and understanding of the official language of the third country for which accreditation or a licence is sought. 3. The requirements set out in paragraph 2 shall be deemed to be met where the environmental verifier demonstrates the existence of a contractual relationship between itself and a qualified person or organisation fulfilling those requirements. That person or organisation shall be independent of the organisation to be verified. Article 23 Supervision of environmental verifiers 1. Supervision of verification and validation activities carried out by environmental verifiers in: (a) the Member State where they are accredited or licensed shall be carried out by the Accreditation or Licensing Body that granted the accreditation or licence; (b) a third country shall be carried out by the Accreditation or Licensing Body that granted the accreditation or licence to the environmental verifier for those activities; (c) a Member State other than where the accreditation or licence was granted shall be carried out by the Accreditation or Licensing Body of the Member State where the verification takes place. 2. At least four weeks in advance of each verification in a Member State, the environmental verifier shall notify its accreditation or licence details and the time and place of the verification to the Accreditation or Licensing Body responsible for the supervision of the environmental verifier concerned. 3. The environmental verifier shall immediately inform the Accreditation or Licensing Body of any changes which have a bearing on the accreditation or licence or their scope. 4. Provision shall be made by the Accreditation or Licensing Body, at regular intervals not exceeding 24 months, to ensure that the environmental verifier continues to comply with the accreditation or licence requirements and to monitor the quality of the verification and validation activities undertaken. 5. Supervision may consist of an office audit, on-the-spot supervision in organisations, questionnaires, a review of environmental statements or updated environmental statements validated by the environmental verifiers and review of the verification report. Supervision shall be proportionate to the activity undertaken by the environmental verifier. 6. Organisations must allow the Accreditation or Licensing Bodies to supervise the environmental verifier during the verification and validation process. 7. Any decision taken by the Accreditation or Licensing Body to terminate or suspend the accreditation or licence or restrict the scope of the accreditation or licence shall be taken only after the environmental verifier has had the possibility of a hearing. 8. If the supervising Accreditation or Licensing Body is of the opinion that the quality of the work of an environmental verifier does not meet the requirements of this Regulation, a written supervision report shall be transmitted to the environmental verifier concerned and to the Competent Body to which the organisation concerned intends to apply for registration or which registered the organisation concerned. In the case of any further dispute, the supervision report shall be transmitted to the Forum of Accreditation and Licensing Bodies referred to in Article 30. Article 24 Additional requirements for supervision of environmental verifiers active in a Member State other than that where the accreditation or license was granted 1. An environmental verifier accredited or licensed in one Member State shall, at least four weeks before performing verification and validation activities in another Member State, notify to the Accreditation or Licensing Body of the latter Member State the following information: (a) its accreditation or licence details, competences, in particular knowledge of legal requirements relating to the environment and official language of the other Member State, and team composition if appropriate; (b) the time and place of the verification and validation; (c) the address and contact details of the organisation. That notification shall be provided before each verification and validation activity. 2. The Accreditation or Licensing Body may request clarification of the verifier's knowledge of the necessary applicable legal requirements relating to the environment. 3. The Accreditation or Licensing Body may require conditions other than those referred to in paragraph 1 only where those other conditions do not prejudice the right of the environmental verifier to provide services in a Member State other than the one where the accreditation or licence was granted. 4. The Accreditation or Licensing Body shall not use the procedure referred to in paragraph 1 to delay the arrival of the environmental verifier. Where the Accreditation or Licensing Body is not able to fulfil its tasks in accordance with paragraphs 2 and 3 before the time for verification and validation as notified by the verifier in accordance with paragraph 1(b), it shall communicate a reasoned justification to the verifier. 5. No discriminatory fees for notification and supervision shall be charged by the Accreditation or Licensing Bodies. 6. Where the supervising Accreditation or Licensing Body is of the opinion that the quality of the work of the environmental verifier does not meet the requirements of this Regulation, a written supervision report shall be transmitted to the environmental verifier concerned, the Accreditation or Licensing Body which granted the accreditation or licence, and the Competent Body to which the organisation concerned intends to apply for registration or which registered the organisation concerned. In the case of any further dispute the supervision report shall be transmitted to the Forum of Accreditation and Licensing Bodies referred to in Article 30. Article 25 Conditions for performing verification and validation 1. The environmental verifier shall operate within the scope of its accreditation or licence, and on the basis of a written agreement with the organisation. That agreement shall: (a) specify the scope of the activity; (b) specify conditions aimed at enabling the environmental verifier to operate in an independent professional manner; and (c) commit the organisation to providing the necessary cooperation. 2. The environmental verifier shall ensure that the components of the organisation are unambiguously defined and correspond to a real division of the activities. The environmental statement shall clearly specify the different parts of the organisation that are subject to verification or validation. 3. The environmental verifier shall carry out an assessment of the elements set out in Article 18. 4. As part of the verification and validation activities the environmental verifier shall examine documentation, visit the organisation, carry out spot-checks and conduct interviews with personnel. 5. Prior to a visit by the environmental verifier, the organisation shall provide it with basic information about the organisation and its activities, the environmental policy and programme, the description of the environmental management system in operation in the organisation, details of the environmental review or audit carried out, the report on that review or audit and on any corrective action taken afterwards, and the draft environmental statement or updated environmental statement. 6. The environmental verifier shall prepare a written report for the organisation, on the outcome of the verification, which shall specify: (a) all issues relevant to the activity carried out by the environmental verifier; (b) a description of conformity with all requirements of this Regulation including supporting evidence, findings and conclusions; (c) the comparison of the achievements and targets with the previous environmental statements and the environmental performance assessment and assessment of the continuous environmental performance improvement of the organisation; (d) if applicable, technical defects in the environmental review, audit method, environmental management system, or any other relevant process. 7. In cases of non-conformity with the provisions of this Regulation, the report shall specify in addition: (a) findings and conclusions on the non-conformity by the organisation and evidence on which those findings and conclusion are based; (b) points of disagreement with the draft environmental statement or updated environmental statement, and details of the amendments or additions that should be made to the environmental statement or updated environmental statement. 8. After verification, the environmental verifier shall validate the organisation's environmental statement or updated environmental statement and confirm that it meets the requirements of this Regulation provided that the outcome of the verification and validation confirms that: (a) the information and data in the organisation's environmental statement or updated environmental statement are reliable and correct and meet the requirements of this Regulation; and (b) there is no evidence that the organisation does not fulfil applicable legal requirements relating to the environment. 9. Upon validation, the environmental verifier shall issue a signed declaration as referred to in Annex VII declaring that the verification and validation were carried out in accordance with this Regulation. 10. Environmental verifiers accredited or licensed in one Member State may perform verification and validation activities in any other Member State in accordance with the requirements set out in this Regulation. The verification or validation activity shall be subject to supervision by the Accreditation or Licensing Body of the Member State where the activity is to be performed. The start of the activity shall be notified to that Accreditation or Licensing Body in accordance with the timing set out in Article 24(1). Article 26 Verification and validation of small organisations 1. When carrying out verification and validation activities, the environmental verifier shall take into account specific characteristics of small organisations, including the following: (a) short reporting lines; (b) multifunctional staff; (c) on-the-job training; (d) the ability to adapt rapidly to change; and (e) limited documentation of procedures. 2. The environmental verifier shall conduct verification or validation in a way that does not impose unnecessary burdens on small organisations. 3. The environmental verifier shall take into account objective evidence that a system is effective, including the existence of procedures within the organisation that are proportionate to the size and complexity of the operation, the nature of the associated environmental impacts and the competence of the operators. Article 27 Conditions for verification and validation in third countries 1. Environmental verifiers accredited or licensed in a Member State may perform verification and validation activities for an organisation located in a third country in accordance with the requirements set out in this Regulation. 2. At least six weeks before verification or validation in a third country, the environmental verifier shall notify its accreditation or licence details and the time and place of the verification or validation to the Accreditation or Licensing Body of the Member State in which the organisation concerned intends to apply for registration or is registered. 3. The verification and validation activities shall be subject to supervision by the Accreditation or Licensing Body of the Member State in which the environmental verifier is accredited or licensed. The start of the activity shall be notified to that Accreditation or Licensing Body in accordance with the timing set out in paragraph 2. CHAPTER VI ACCREDITATION AND LICENSING BODIES Article 28 Operation of Accreditation and Licensing 1. Accreditation Bodies appointed by the Member States pursuant to Article 4 of Regulation (EC) No 765/2008 shall be responsible for the accreditation of environmental verifiers and the supervision of the activities carried out by environmental verifiers in accordance with this Regulation. 2. Member States may appoint a Licensing Body, in accordance with Article 5(2) of Regulation (EC) No 765/2008, which shall be responsible for issuing licences to and supervising environmental verifiers. 3. Member States may decide not to allow the accreditation or licensing of natural persons as environmental verifiers. 4. Accreditation and Licensing Bodies shall assess an environmental verifier's competence in the light of the elements set out in Articles 20, 21 and 22 relevant to the scope of the requested accreditation or licence. 5. The scope of accreditation or the licence of environmental verifiers shall be determined according to the classification of economic activities as set out in Regulation (EC) No 1893/2006. That scope shall be limited by the competence of the environmental verifier and, where appropriate, it shall take into account the size and complexity of the activity. 6. Accreditation and Licensing Bodies shall establish appropriate procedures on accreditation or licensing, refusal of accreditation or a licence, suspension and withdrawal of accreditation or a licence of environmental verifiers and on supervision of environmental verifiers. Those procedures shall include mechanisms for considering observations from concerned parties, including Competent Bodies and the representative bodies of organisations, concerning applicants and accredited or licensed environmental verifiers. 7. In the case of a refusal of accreditation or licence, the Accreditation or Licensing Body shall inform the environmental verifier of the reasons for the decision. 8. Accreditation or Licensing Bodies shall establish, revise and update a list of environmental verifiers and their scope of accreditation or licence in their Member States and shall communicate each month, directly or via the national authorities as decided by the Member State concerned, changes in that list to the Commission and to the Competent Body of the Member State where the Accreditation or Licensing Body is located. 9. Within the framework of the rules and procedures regarding monitoring of activities as laid down in Article 5(3) of Regulation (EC) No 765/2008, Accreditation and Licensing Bodies shall draw up a supervision report where they decide, after consultation with the environmental verifier concerned, either of the following: (a) that the activities of the environmental verifier were not performed adequately enough to ensure that the requirements of this Regulation are met by the organisation; (b) that the verification and the validation by the environmental verifier were carried out in violation of one or more of the requirements of this Regulation. This report shall be transmitted to the Competent Body in the Member State where the organisation is registered or applies for registration and, if applicable, to the Accreditation or Licensing Body that granted the accreditation or licence. Article 29 Suspension and withdrawal of accreditation or license 1. Suspension or withdrawal of the accreditation or licence shall require the consultation of concerned parties including the environmental verifier, in order to provide the Accreditation or Licensing Body with the necessary evidence for taking its decision. 2. The Accreditation or Licensing Body shall inform the environmental verifier of the reasons for the measures taken and, if applicable, of the process of discussion with the competent enforcement authority. 3. The accreditation or licence shall be suspended or withdrawn until assurance of the environmental verifier's compliance with this Regulation is obtained, as appropriate, depending on the nature and scope of the failure or violation of legal requirements. 4. Suspension of the accreditation or licence shall be lifted where the Accreditation or Licensing Body has received satisfactory information that the environmental verifier complies with this Regulation. Article 30 Forum of the Accreditation and Licensing Bodies 1. A forum constituted of all the Accreditation and Licensing Bodies from all Member States, hereinafter referred to as \u2018the Forum of the Accreditation and Licensing Bodies\u2019, shall be set up and meet at least once per year in the presence of a representative of the Commission. 2. The task of the Forum of the Accreditation and Licensing Bodies shall be to ensure the consistency of procedures relating to the following: (a) the accreditation or licensing of environmental verifiers under this Regulation, including refusal, suspension and withdrawal of accreditation or licence; (b) the supervision of activities carried out by accredited or licensed environmental verifiers. 3. The Forum of the Accreditation and Licensing Bodies shall develop guidance on issues in the field of the competence of Accreditation and Licensing Bodies. 4. The Forum of the Accreditation and Licensing Bodies shall adopt its rules of procedure. 5. The guidance documents referred to in paragraph 3 and the rules of procedure referred to in paragraph 4 shall be transmitted to the Commission. 6. Guidance documents referring to harmonisation procedures approved by the Forum of the Accreditation and Licensing Bodies shall be proposed as appropriate by the Commission for adoption in accordance with the regulatory procedure with scrutiny referred to in Article 49(3). These documents shall be made publicly available. Article 31 Peer evaluation of Accreditation and Licensing Bodies 1. The peer evaluation with regard to accreditation and licensing of environmental verifiers under this Regulation to be organised by the Forum of Accreditation and Licensing Bodies, shall be carried out on a regular basis, at least every four years, and shall include an assessment of the rules and procedures set out in Articles 28 and 29. All Accreditation and Licensing Bodies shall participate in the peer evaluation. 2. The Forum of Accreditation and Licensing Bodies shall transmit a regular report of the peer evaluation to the Commission and the Committee established under Article 49(1). That report shall be made publicly available after approval by the Forum of Accreditation and Licensing Bodies and the Committee referred to in the first subparagraph. CHAPTER VII RULES APPLICABLE TO MEMBER STATES Article 32 Assistance to organisations relating to compliance with legal requirements relating to the environment 1. Member States shall ensure that organisations get access to information and assistance possibilities regarding legal requirements relating to the environment in that Member State. 2. The assistance shall include the following: (a) information regarding the applicable legal requirements relating to the environment; (b) identification of the competent enforcement authorities for specific legal requirements relating to the environment that have been identified as being applicable. 3. Member States may confer the tasks referred to in paragraphs 1 and 2 to the Competent Bodies or to any other body having the necessary expertise and the appropriate resources to fulfil the task. 4. Member States shall ensure that enforcement authorities reply to requests, at least from small organisations, on the applicable legal requirements relating to the environment that fall within their competence, and provide information to the organisations on the means of showing how the organisations meet relevant legal requirements. 5. Member States shall ensure that competent enforcement authorities communicate a failure by registered organisations to comply with applicable legal requirements relating to the environment to the Competent Body which has registered the organisation. The competent enforcement authority shall inform that Competent Body as soon as possible and in any case within one month after it has become aware of the failure. Article 33 Promotion of EMAS 1. Member States shall, in conjunction with Competent Bodies, enforcement authorities and other relevant stakeholders, promote the EMAS scheme taking into account activities referred to in Articles 34 to 38. 2. To that end, Member States may establish a promotion strategy which shall be revised on a regular basis. Article 34 Information 1. Member States shall take appropriate measures to provide information to: (a) the public about the objectives and principal components of EMAS; (b) organisations about the contents of this Regulation. 2. Member States shall, where appropriate, use professional publications, local journals, promotion campaigns or any other functional means to increase general awareness of EMAS. Member States may cooperate, in particular, with industrial associations, consumer organisations, environmental organisations, trade unions, local institutions and other relevant stakeholders. Article 35 Promotion activities 1. Member States shall carry out promotion activities for EMAS. These activities may include: (a) the promotion of the exchange of knowledge and best practices on EMAS among all concerned parties; (b) the development of effective tools for EMAS promotion and to share them with organisations; (c) the provision of technical support to organisations in the definition and implementation of their EMAS-related marketing activities; (d) the encouragement of partnerships among organisations for EMAS promotion. 2. The EMAS logo without a registration number may be used by Competent Bodies, Accreditation and Licensing Bodies, national authorities and other stakeholders for EMAS-related marketing and promotional purposes. In such cases, use of the EMAS logo set out in Annex V shall not suggest that the user is registered where this is not the case. Article 36 Promotion of participation of small organisations Member States shall take adequate measures to encourage the participation of small organisations, inter alia, by: (a) facilitating access to information and support funds specially adapted to them; (b) ensuring that reasonable registration fees encourage their participation; (c) promoting technical assistance measures. Article 37 Cluster and step-by-step approach 1. Member States shall encourage local authorities to provide, in participation with industrial associations, chambers of commerce and other concerned parties, specific assistance to clusters of organisations to meet the requirements for registration as referred to in Articles 4, 5 and 6. Each organisation from the cluster shall be registered separately. 2. Member States shall encourage organisations to implement an environment management system. They shall in particular encourage a step-by-step approach leading to EMAS registration. 3. Systems established pursuant to paragraphs 1 and 2 shall operate with the objective of avoiding unnecessary costs for participants, in particular for small organisations. Article 38 EMAS and other policies and instruments in the Community 1. Without prejudice to Community legislation, Member States shall consider how registration under EMAS in accordance with this Regulation can be: (a) taken into account in the development of new legislation; (b) used as a tool in the application and enforcement of legislation; (c) taken into account in public procurement and purchasing. 2. Without prejudice to Community legislation, notably competition, taxation and State aid legislation, Member States shall, where appropriate, take measures facilitating organisations to become or remain EMAS registered. Those measures may include, inter alia, the following: (a) regulatory relief, so that a registered organisation is considered as being compliant with certain legal requirements relating to the environment laid down in other legal instruments, identified by the competent authorities; (b) better regulation, whereby other legal instruments are modified so that burdens on organisations participating in EMAS are removed, reduced or simplified with a view to encouraging the efficient operation of markets and raising the level of competitiveness. Article 39 Fees 1. Member States may charge fees taking into account the following: (a) the costs incurred in connection with the provision of information and assistance to organisations by the bodies designated or set up to that end by Member States pursuant to Article 32; (b) the costs incurred in connection with the accreditation, licensing and supervision of environmental verifiers; (c) the costs for registration, renewal of registration, suspension and deletion by Competent Bodies as well as the additional costs of administering those processes for organisations outside the Community. Those fees shall not exceed a reasonable amount and shall be proportionate to the size of the organisation and to the work to be done. 2. Member States shall ensure that organisations are informed about all applicable fees. Article 40 Non-compliance 1. Member States shall take appropriate legal or administrative measures in case of non-compliance with this Regulation. 2. Member States shall put in place effective provisions against the use of the EMAS logo in violation of this Regulation. Provisions put in place in accordance with Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (12) may be used. Article 41 Information and reporting to the Commission 1. Member States shall inform the Commission of the structure and procedures relating to the functioning of the Competent Bodies and Accreditation and Licensing Bodies and shall update that information, where appropriate. 2. Every two years, Member States shall report to the Commission updated information on the measures taken pursuant to this Regulation. In those reports, Member States shall take account of the latest report presented by the Commission to the European Parliament and to the Council pursuant to Article 47. CHAPTER VIII RULES APPLICABLE TO THE COMMISSION Article 42 Information 1. The Commission shall provide information to: (a) the public on the objectives and principal components of EMAS; (b) organisations on the content of this Regulation. 2. The Commission shall maintain and make publicly available: (a) a register of environmental verifiers and registered organisations; (b) a database of environmental statements in electronic format; (c) a database of best practices on EMAS, including, inter alia, effective tools for EMAS promotion and examples of technical support to organisations; (d) a list of Community resources for the funding of EMAS implementation and related projects and activities. Article 43 Collaboration and coordination 1. The Commission shall promote, as appropriate, collaboration between Member States in order, in particular, to achieve a uniform and consistent application of the rules throughout the Community relating to the following: (a) registration of organisations; (b) environmental verifiers; (c) the information and assistance referred to in Article 32. 2. Without prejudice to Community legislation on public procurement, the Commission and other Community institutions and bodies shall, where appropriate, refer to EMAS or other environmental management systems recognised in accordance with Article 45, or equivalent, as contract performance conditions for works and service contracts. Article 44 Integration of EMAS into other policies and instruments in the Community The Commission shall consider how registration under EMAS in accordance with this Regulation can be: 1. taken into account in the development of new legislation and revision of existing legislation, in particular in the form of regulatory relief and better regulation as described in Article 38(2); 2. used as a tool in the context of application and enforcement of legislation. Article 45 Relationship with other environmental management systems 1. Member States may submit to the Commission a written request for recognition of existing environmental management systems, or parts thereof, that are certified in accordance with appropriate certification procedures recognised at national or regional level as complying with corresponding requirements of this Regulation. 2. Member States shall specify in their request the relevant parts of the environmental management systems and the corresponding requirements of this Regulation. 3. Member States shall provide evidence of the equivalence with this Regulation of all relevant parts of the environmental management system concerned. 4. The Commission shall, after examination of the request referred to in paragraph 1, and acting in accordance with the advisory procedure referred to in Article 49(2), recognise the relevant parts of the environmental management systems and recognise the accreditation or licensing requirements for the certification bodies if it is of the opinion that a Member State has: (a) specified sufficiently clearly in the request the relevant parts of the environmental management systems and the corresponding requirements of this Regulation; (b) provided sufficient evidence of the equivalence with this Regulation of all relevant parts of the environmental management system at stake. 5. The Commission shall publish the references of the recognised environmental management systems, including the relevant sections of EMAS referred to in Annex I to which those references apply, and the recognised accreditation or licensing requirements in the Official Journal of the European Union. Article 46 Development of reference documents and guides 1. The Commission shall, in consultation with Member States and other stakeholders, develop sectoral reference documents that shall include: (a) best environmental management practice; (b) environmental performance indicators for specific sectors; (c) where appropriate, benchmarks of excellence and rating systems identifying environmental performance levels. The Commission may also develop reference documents for cross-sectoral use. 2. The Commission shall take into account existing reference documents and environmental performance indicators developed in accordance with other environmental policies and instruments in the Community or international standards. 3. The Commission shall establish, by the end of 2010, a working plan setting out an indicative list of sectors, which will be considered priorities for the adoption of sectoral and cross-sectoral reference documents. The working plan shall be made publicly available and regularly updated. 4. The Commission shall, in cooperation with the Forum of Competent Bodies, develop a guide on registration of organisations outside the Community. 5. The Commission shall publish a user's guide setting out the steps needed to participate in EMAS. That guide shall be available in all official languages of the institutions of the European Union and online. 6. Documents developed in accordance with paragraphs 1 and 4 shall be submitted for adoption. Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3). Article 47 Reporting Every five years, the Commission shall submit to the European Parliament and to the Council a report containing information on the actions and measures taken under this Chapter and information received from the Member States pursuant to Article 41. The report shall include an assessment of the impact of the scheme on the environment and the trend in terms of number of participants. CHAPTER IX FINAL PROVISIONS Article 48 Amendment of Annexes 1. The Commission may amend the Annexes if necessary or appropriate, in the light of experience gained in the operation of EMAS, in response to identified needs for guidance on EMAS requirements and in the light of any changes in international standards or new standards which are of relevance to the effectiveness of this Regulation. 2. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3). Article 49 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 50 Review The Commission shall review EMAS in the light of the experience gained during its operation and international developments by 11 January 2015. It shall take into account the reports transmitted to the European Parliament and to the Council in accordance with Article 47. Article 51 Repeal and transitional provisions 1. The following legal acts shall be repealed: (a) Regulation (EC) No 761/2001; (b) Commission Decision 2001/681/EC of 7 September 2001 on guidance for the implementation of Regulation (EC) No 761/2001 of the European Parliament and of the Council allowing voluntary participation by organisations in a Community Eco-management and audit scheme (EMAS) (13); (c) Commission Decision 2006/193/EC of 1 March 2006 laying down rules, under Regulation (EC) No 761/2001 of the European Parliament and of the Council, on the use of the EMAS logo in the exceptional cases of transport packaging and tertiary packaging (14). 2. By way of derogation from paragraph 1: (a) national Accreditation Bodies and Competent Bodies set up pursuant to Regulation (EC) No 761/2001 shall continue their activities. Member States shall modify the procedures followed by Accreditation Bodies and Competent Bodies in accordance with this Regulation. Member States shall ensure that the systems implementing the modified procedures are fully operational by11 January 2011; (b) organisations registered in accordance with Regulation (EC) No 761/2001 shall remain on the EMAS register. At the time of the next verification of an organisation the environmental verifier shall check its compliance with the new requirements of this Regulation. If the next verification is to be carried out before 11 July 2010, the date of the next verification may be extended by six months in agreement with the environmental verifier and the Competent Bodies; (c) environmental verifiers accredited in accordance with Regulation (EC) No 761/2001 may continue to perform their activities in accordance with the requirements established by this Regulation. 3. References to Regulation (EC) No 761/2001 shall be construed as references to this Regulation and be read in accordance with the correlation table set out in Annex VIII. Article 52 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 November 2009. For the European Parliament The President J. BUZEK For the Council The President \u00c5. TORSTENSSON (1) Opinion of 25 February 2009 (not yet published in the Official Journal). (2) OJ C 120, 28.5.2009, p. 56. (3) Opinion of the European Parliament of 2 April 2009 (not yet published in the Official Journal) and Council Decision of 26 October 2009. (4) OJ L 242, 10.9.2002, p. 1. (5) OJ L 114, 24.4.2001, p. 1. (6) OJ L 218, 13.8.2008, p. 30. (7) OJ L 247, 17.9.2001, p. 1. (8) OJ L 184, 23.7.2003, p. 19. (9) OJ L 184, 17.7.1999, p. 23. (10) OJ L 124, 20.5.2003, p. 36. (11) Regulation (EC) No 1893/2006 of the European Parliament and of the Council of 20 December 2006 establishing the statistical classification of economic activities NACE Revision 2 (OJ L 393, 30.12.2006, p. 1). (12) OJ L 149, 11.6.2005, p. 22. (13) OJ L 247, 17.9.2001, p. 24. (14) OJ L 70, 9.3.2006, p. 63. ANNEX I ENVIRONMENTAL REVIEW The environmental review shall cover the following areas: 1. Identification of the applicable legal requirements relating to the environment. In addition to the establishment of a list of applicable legal requirements, the organisation shall also indicate how evidence that it is complying with the different requirements can be provided. 2. Identification of all direct and indirect environmental aspects with a significant impact on the environment, qualified and quantified as appropriate and compiling a register of those identified as significant; An organisation shall consider the following issues in assessing the significance of an environmental aspect: (i) potential to cause environmental harm; (ii) fragility of the local, regional or global environment; (iii) size, number, frequency and reversibility of the aspect or impact; (iv) existence and requirements of relevant environmental legislation; (v) importance to the stakeholders and employees of the organisation. (a) Direct environmental aspects Direct environmental aspects are associated with activities, products and services of the organisation itself over which it has direct management control. All organisations have to consider the direct aspects of their operations. Direct environmental aspects relate to, but are not limited to: (i) legal requirements and permit limits; (ii) emissions to air; (iii) releases to water; (iv) production, recycling, reuse, transportation and disposal of solid and other wastes, particularly hazardous wastes; (v) use and contamination of land; (vi) use of natural resources and raw materials (including energy); (vii) use of additives and auxiliaries as well as semi-manufactured goods; (viii) local issues (noise, vibration, odour, dust, visual appearance, etc.); (ix) transport issues (both for goods and services); (x) risks of environmental accidents and impacts arising, or likely to arise, as consequences of incidents, accidents and potential emergency situations; (xi) effects on biodiversity. (b) Indirect environmental aspects Indirect environmental aspects can result from the interaction of an organisation with third parties which can to a reasonable degree be influenced by the organisation seeking EMAS-registration. For non-industrial organisations, such as local authorities or financial institutions, it is essential that they also consider the environmental aspects associated with their core business. An inventory limited to the environmental aspects of an organisation's site and facilities is insufficient. These include, but are not limited to: (i) product life cycle related issues (design, development, packaging, transportation, use and waste recovery/disposal); (ii) capital investments, granting loans and insurance services; (iii) new markets; (iv) choice and composition of services (e.g. transport or the catering trade); (v) administrative and planning decisions; (vi) product range compositions; (vii) the environmental performance and practices of contractors, subcontractors and suppliers. Organisations must be able to demonstrate that the significant environmental aspects associated with their procurement procedures have been identified and that significant environmental impacts associated with these aspects are addressed within the management system. The organisation should endeavour to ensure that the suppliers and those acting on the organisation's behalf comply with the organisation's environmental policy within the remit of the activities carried out for the contract. In the case of these indirect environmental aspects, an organisation shall consider how much influence it can have over these aspects, and what measures can be taken to reduce the environmental impact. 3. Description of the criteria for assessing the significance of the environmental impact An organisation shall define the criteria for assessing the significance of the environmental aspects of its activities, products and services, to determine which have a significant environmental impact. The criteria developed by an organisation shall take into account Community legislation and shall be comprehensive, capable of independent checking, reproducible and made publicly available. Considerations in establishing the criteria for assessing the significance of an organisation's environmental aspects may include, but are not limited to: (a) information about the condition of the environment to identify activities, products and services of the organisation that may have an environmental impact; (b) the organisation's existing data on material and energy inputs, discharges, wastes and emissions in terms of risk; (c) views of interested parties; (d) environmental activities of the organisation that are regulated; (e) procurement activities; (f) design, development, manufacturing, distribution, servicing, use, re-use, recycling and disposal of the organisation's products; (g) those activities of the organisation with the most significant environmental costs, and environmental benefits. In assessing the significance of the environmental impacts of the organisation's activities the organisation shall think not only of normal operating conditions but also of start-up and shutdown conditions and of reasonably foreseeable emergency conditions. Account shall be taken of past, present and planned activities. 4. Examination of all existing environmental management practices and procedures. 5. Evaluation of feedback from the investigation of previous incidents. ANNEX II Environmental management system requirements and additional issues to be addressed by organisations implementing EMAS The environmental management system requirements under EMAS are those laid down in Section 4 of the EN ISO 14001:2004 standard. These requirements are reproduced in the left column of the table below, which constitutes Part A of this Annex. In addition, registered organisations are required to address a number of additional issues that have a direct link to a number of elements of Section 4 of the EN ISO 14001:2004 standard. These additional requirements are listed in the right column below, which constitutes Part B of this Annex. PART A environmental management systems requirements under EN ISO 14001:2004 PART B additional issues to be addressed by organisations implementing EMAS Organisations participating in the eco-management and audit scheme (EMAS) shall implement the requirements of EN ISO 14001:2004, which are described in Section 4 of the European Standard (1) and are fully reproduced below: A. Environmental management system requirements A.1. General requirements The organisation shall establish, document, implement, maintain and continually improve an environmental management system in accordance with the requirements of this International Standard and determine how it will fulfill these requirements. The organisation shall define and document the scope of its environmental management system. A.2. Environmental policy Top management shall define the organisation's environmental policy and ensure that, within the defined scope of its environmental management system, it: (a) is appropriate to the nature, scale and environmental impacts of its activities, products and services; (b) includes a commitment to continual improvement and prevention of pollution; (c) includes a commitment to comply with applicable legal requirements and with other requirements to which the organisation subscribes which relate to its environmental aspects; (d) provides the framework for setting and reviewing environmental objectives and targets; (e) is documented, implemented and maintained; (f) is communicated to all persons working for or on behalf of the organisation; and (g) is available to the public. A.3. Planning A.3.1. Environmental aspects The organisation shall establish, implement and maintain a procedure(s): (a) to identify the environmental aspects of its activities, products and services within the defined scope of the environmental management system that it can control and those that it can influence taking into account planned or new developments, or new or modified activities, products and services; and (b) to determine those aspects that have or can have significant impact(s) on the environment (i.e. significant environmental aspects). The organisation shall document this information and keep it up to date. The organisation shall ensure that the significant environmental aspects are taken into account in establishing, implementing and maintaining its environmental management system. B.1. Environmental review Organisations shall carry out an initial environmental review as set out in Annex I in order to identify and evaluate their environmental aspects and identify applicable legal requirements relating to the environment. Organisations outside the Community shall also make reference to the legal requirements relating to the environment applicable to similar organisations in the Member States where they intend to submit an application. A.3.2. Legal and other requirements The organisation shall establish, implement and maintain a procedure(s): (a) to identify and have access to the applicable legal requirements and other requirements to which the organisation subscribes related to its environmental aspects; and (b) to determine how these requirements apply to its environmental aspects. The organisation shall ensure that these applicable legal requirements and other requirements to which the organisation subscribes are taken into account in establishing, implementing and maintaining its environmental management system. B.2. Legal compliance Organisations wishing to register with EMAS shall be able to demonstrate that they: (1) have identified, and know the implications to the organisation of all applicable legal requirements relating to the environment, identified during the environmental review according to Annex I. (2) provide for legal compliance with environmental legislation, including permits and permit limits; and (3) have procedures in place that enable the organisation to meet these requirements on an ongoing basis. A.3.3. Objectives, targets and programme(s) The organisation shall establish, implement and maintain documented environmental objectives and targets, at relevant functions and levels within the organisation. The objectives and targets shall be measurable, where practicable, and consistent with the environmental policy, including the commitments to prevention of pollution, to compliance with applicable legal requirements and with other requirements to which the organisation subscribes, and to continual improvement. When establishing and reviewing its objectives and targets, an organisation shall take into account the legal requirements and other requirements to which the organisation subscribes, and its significant environmental aspects. It shall also consider its technological options, its financial, operational and business requirements, and the views of interested parties. The organisation shall establish, implement and maintain a programme(s) for achieving its objectives and targets. Programme(s) shall include: (a) designation of responsibility for achieving objectives and targets at relevant functions and levels of the organisation; and (b) the means and time-frame by which they are to be achieved. B.3. Environmental performance (1) Organisations shall be able to demonstrate that the management system and the audit procedures address the actual environmental performance of the organisation with respect to the direct and indirect aspects identified in the environmental review under Annex I. (2) The environmental performance of the organisation against its objectives and targets shall be evaluated as part of the management review process. The organisation shall also commit itself to the continual improvement of its environmental performance. In doing so, the organisation may base its action on local, regional and national environmental programmes. (3) The means to achieve the objectives and targets cannot be environmental objectives. If the organisation comprises one or more sites, each of the sites to which EMAS applies shall comply with all the requirements of EMAS including the continual improvement of environmental performance as defined in Article 2(2). A.4. Implementation and operation A.4.1. Resources, roles, responsibility and authority Management shall ensure the availability of resources essential to establish, implement, maintain and improve the environmental management system. Resources include human resources and specialised skills, organisational infrastructure, technology and financial resources. Roles, responsibilities and authorities shall be defined, documented and communicated in order to facilitate effective environmental management. The organisation's top management shall appoint a specific management representative(s) who, irrespective of other responsibilities, shall have defined roles, responsibilities and authority for: (a) ensuring that an environmental management system is established, implemented and maintained in accordance with the requirements of this International Standard; (b) reporting to top management on the performance of the environmental management system for review, including recommendations for improvement. A.4.2. Competence, training and awareness B.4. Employee involvement (1) The organisation should acknowledge that active employee involvement is a driving force and a prerequisite for continuous and successful environmental improvements as well as being a key resource in the improvement of environmental performance as well as the right method to anchor the environmental management and audit system in the organisation in a successful way. (2) The term \u2018employee participation\u2019 includes both participation of, and information to the individual employee and his representatives. Therefore, there should be an employee participation scheme at all levels. The organisation should acknowledge that commitment, responsiveness and active support from the side of the management is a prerequisite for the success of those processes. In this context the necessity of feedback from the management to the employees must be stressed. The organisation shall ensure that any person(s) performing tasks for it or on its behalf that have the potential to cause a significant environmental impact(s) identified by the organisation is (are) competent on the basis of appropriate education, training or experience, and shall retain associated records. The organisation shall identify training needs associated with its environmental aspects and its environmental management system. It shall provide training or take other action to meet these needs, and shall retain associated records. The organisation shall establish, implement and maintain a procedure(s) to make persons working for it or on its behalf aware of: (a) the importance of conformity with the environmental policy and procedures and with the requirements of the environmental management system; (b) the significant environmental aspects and related actual or potential impacts associated with their work, and the environmental benefits of improved personal performance; (c) their roles and responsibilities in achieving conformity with the requirements of the environmental management system; and (d) the potential consequences of departure from specified procedures. (3) In addition to the these requirements, employees shall be involved in the process aimed at continually improving the organisation's environmental performance through: (a) the initial environmental review, the analysis of the status quo and in collecting and verifying information, (b) the establishment and implementation of an environmental management and audit system improving environmental performance, (c) environmental committees to gather information and to ensure the participation of environmental officer/management representatives and employees and their representatives, (d) joint working groups for the environmental action programme and environmental auditing, (e) the elaboration of the environmental statements. (4) Appropriate forms of participation such as the suggestion-book system or project-based group works or environmental committees should be used for this purpose. Organisations shall take note of Commission guidance on best practice in this field. Where they so request, any employee representatives shall also be involved. A.4.3. Communication With regard to its environmental aspects and environmental management system, the organisation shall establish, implement and maintain a procedure(s) for: (a) internal communication among the various levels and functions of the organisation; (b) receiving, documenting and responding to relevant communication from external interested parties. The organisation shall decide whether to communicate externally about its significant environmental aspects, and shall document its decision. If the decision is to communicate, the organisation shall establish and implement a method(s) for this external communication. B.5. Communication (1) Organisations shall be able to demonstrate an open dialogue with the public and other interested parties including local communities and customers with regard to the environmental impact of their activities, products and services in order to identify the public's and other interested parties' concerns. (2) Openness, transparency and periodic provision of environmental information are key factors in differentiating EMAS from other schemes. Those factors are also important for the organisation in building confidence with interested parties. (3) EMAS provides flexibility to allow organisations to target relevant information to specific audiences while ensuring that all information is available to those who require it. A.4.4. Documentation The environmental management system documentation shall include: (a) the environmental policy, objectives and targets; (b) description of the scope of the environmental management system; (c) description of the main elements of the environmental management system and their interaction, and reference to related documents; (d) documents, including records, required by this International Standard; and (e) documents, including records, determined by the organisation to be necessary to ensure the effective planning, operation and control of processes that relate to its significant environmental aspects. A.4.5. Control of documents Documents required by the environmental management system and by this International Standard shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements given in point A.5.4. The organisation shall establish, implement and maintain a procedure(s) to: (a) approve documents for adequacy prior to issue; (b) review and update as necessary and re-approve documents, (c) ensure that changes and the current revision status of documents are identified; (d) ensure that relevant versions of applicable documents are available at points of use; (e) ensure that documents remain legible and readily identifiable; (f) ensure that documents of external origin determined by the organisation to be necessary for the planning and operation of the environmental management system are identified and their distribution controlled; and (g) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose. A.4.6. Operational control The organisation shall identify and plan those operations that are associated with the identified significant environmental aspects consistent with its environmental policy, objectives and targets, in order to ensure that they are carried out under specified conditions, by: (a) establishing, implementing and maintaining a documented procedure(s) to control situations where their absence could lead to deviation from the environmental policy, objectives and targets; and (b) stipulating the operating criteria in the procedure(s); and (c) establishing, implementing and maintaining procedures related to the identified significant environmental aspects of goods and services used by the organisation and communicating applicable procedures and requirements to suppliers, including contractors. A.4.7. Emergency preparedness and response The organisation shall establish, implement and maintain a procedure(s) to identify potential emergency situations and potential accidents that can have an impact(s) on the environment and how it will respond to them. The organisation shall respond to actual emergency situations and accidents and prevent or mitigate associated adverse environmental impacts. The organisation shall periodically review and, where necessary, revise its emergency preparedness and response procedures, in particular, after the occurrence of accidents or emergency situations. The organisation shall also periodically test such procedures where practicable. A.5. Checking A.5.1. Monitoring and measurement The organisation shall establish, implement and maintain a procedure(s) to monitor and measure, on a regular basis, the key characteristics of its operations that can have a significant environmental impact. The procedure(s) shall include the documenting of information to monitor performance, applicable operational controls and conformity with the organisation's environmental objectives and targets. The organisation shall ensure that calibrated or verified monitoring and measurement equipment is used and maintained and shall retain associated records. A.5.2. Evaluation of compliance A.5.2.1. Consistent with its commitment to compliance, the organisation shall establish, implement and maintain a procedure(s) for periodically evaluating compliance with applicable legal requirements. The organisation shall keep records of the results of the periodic evaluations. A.5.2.2. The organisation shall evaluate compliance with other requirements to which it subscribes. The organisation may wish to combine this evaluation with the evaluation of legal compliance referred to in A.5.2.1 or to establish a separate procedure(s). The organisation shall keep records of the results of the periodic evaluations. A.5.3. Non-conformity, corrective action and preventive action The organisation shall establish, implement and maintain a procedure(s) for dealing with actual and potential non-conformity(ies) and for taking corrective action and preventive action. The procedure(s) shall define requirements for: (a) identifying and correcting non-conformity(ies) and taking action(s) to mitigate their environmental impacts; (b) investigating non-conformity(ies), determining their cause(s) and taking actions in order to avoid their recurrence; (c) evaluating the need for action(s) to prevent non-conformity(ies) and implementing appropriate actions designed to avoid their occurrence; (d) recording the results of corrective action(s) and preventive action(s) taken; and (e) reviewing the effectiveness of corrective action(s) and preventive action(s) taken. Actions taken shall be appropriate to the magnitude of the problems and the environmental impacts encountered. The organisation shall ensure that any necessary changes are made to environmental management system documentation. A.5.4. Control of records The organisation shall establish and maintain records as necessary to demonstrate conformity to the requirements of its environmental management system and of this International Standard, and the results achieved. The organisation shall establish, implement and maintain a procedure(s) for the identification, storage, protection, retrieval, retention and disposal of records. Records shall be and remain legible, identifiable and traceable. A.5.5. Internal audit The organisation shall ensure that internal audits of the environmental management system are conducted at planned intervals to: (a) determine whether the environmental management system: \u2014 conforms to planned arrangements for environmental management including the requirements of this International Standard, and \u2014 has been properly implemented and is maintained; and (b) provide information on the results of audits to management. Audit programme(s) shall be planned, established, implemented and maintained by the organisation, taking into consideration the environmental importance of the operation(s) concerned and the results of previous audits. Audit procedure(s) shall be established, implemented and maintained that address: \u2014 the responsibilities and requirements for planning and conducting audits, reporting results and retaining associated records, \u2014 the determination of audit criteria, scope, frequency and methods. Selection of auditors and conduct of audits shall ensure objectivity and the impartiality of the audit process. A.6. Management review Top management shall review the organisation's environmental management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. Reviews shall include assessing opportunities for improvement and the need for changes to the environmental management system, including the environmental policy and environmental objectives and targets. Records of the management reviews shall be retained. Input to management reviews shall include: (a) results of internal audits and evaluations of compliance with legal requirements and with other requirements to which the organisation subscribes; (b) communication(s) from external interested parties, including complaints; (c) the environmental performance of the organisation; (d) the extent to which objectives and targets have been met; (e) status of corrective and preventive actions; (f) follow-up actions from previous management reviews; (g) changing circumstances, including developments in legal and other requirements related to its environmental aspects; and (h) recommendations for improvement. The outputs from management reviews shall include any decisions and actions related to possible changes to environmental policy, objectives, targets and other elements of the environmental management system, consistent with the commitment to continual improvement. List of national standard bodies BE: IBN/BIN (Institut Belge de Normalisation/Belgisch Instituut voor Normalisatie) CZ: \u010cNI (\u010cesk\u00fd normaliza\u010dn\u00ed institut) DK: DS (Dansk Standard) DE: DIN (Deutsches Institut f\u00fcr Normung e.V.) EE: EVS (Eesti Standardikeskus) EL: ELOT (\u0395\u03bb\u03bb\u03b7\u03bd\u03b9\u03ba\u03cc\u03c2 \u039f\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03cc\u03c2 \u03a4\u03c5\u03c0\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7\u03c2) ES: AENOR (Asociacion Espanola de Normalizacion y Certificacion) FR: AFNOR (Association Fran\u00e7aise de Normalisation) IE: NSAI (National Standards Authority of Ireland) IT: UNI (Ente Nazionale Italiano di Unificazione) CY: \u039a\u03c5\u03c0\u03c1\u03b9\u03b1\u03ba\u03cc\u03c2 \u039f\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03cc\u03c2 \u03a0\u03c1\u03bf\u03ce\u03b8\u03b7\u03c3\u03b7\u03c2 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 LV: LVS (Latvijas Standarts) LT: LST (Lietuvos standartizacijos departamentas) LU: SEE (Service de l\u2019Energie de l\u2019Etat) (Luxembourg) HU: MSZT (Magyar Szabv\u00e1ny\u00fcgyi Test\u00fclet) MT: MSA (Awtorit\u00e0 Maltija dwar l-Istandards/Malta Standards Authority) NL: NEN (Nederlands Normalisatie-Instituut) AT: ON (\u00d6sterreichisches Normungsinstitut) PL: PKN (Polski Komitet Normalizacyjny) PT: IPQ (Instituto Portugu\u00eas da Qualidade) SI: SIST (Slovenski in\u0161titut za standardizacijo) SK: S\u00daTN (Slovensk\u00fd \u00fastav technickej normaliz\u00e1cie) FI: SFS (Suomen Standardisoimisliitto r.y) SE: SIS (Swedish Standards Institute) UK: BSI (British Standards Institution). Complementary list of national standard bodies National standard bodies in Member States not covered by EN ISO 14001:2004: BG: BDS (\u0411\u044a\u043b\u0433\u0430\u0440\u0441\u043a\u0438 \u0438\u043d\u0441\u0442\u0438\u0442\u0443\u0442 \u0437\u0430 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0438\u0437\u0430\u0446\u0438\u044f); RO: ASRO (Asocia\u0163ia de Standardizare din Rom\u00e2nia). National standard bodies in Member States, where a national standard body listed in EN ISO 14001:2004 has been replaced: CZ: \u00daNMZ (\u00dastav pro technickou normalizaci, metrologii a st\u00e1tn\u00ed zku\u0161ebnictv\u00ed). (1) The use of the text reproduced in this Annex is made with the permission of the European Committee for Standardisation (CEN). The full text can be purchased from the national standard bodies, the list of which is given in this Annex. Any reproduction of this Annex for commercial reasons is not permitted. ANNEX III INTERNAL ENVIRONMENTAL AUDIT A. Audit programme and audit frequency 1. Audit programme The audit programme shall guarantee that the management of the organisation is provided with the information it needs to review the organisation's environmental performance and the effectiveness of the environmental management system, and be able to demonstrate that they are under control. 2. Objectives of the audit programme The objectives shall include, in particular, assessing the management systems in place, and determining conformity with the organisation's policy and programme, which shall include compliance with relevant environmental regulatory requirements. 3. Scope of the audit programme The overall scope of the individual audits, or of each stage of an audit cycle where appropriate, shall be clearly defined and shall explicitly specify the: (a) subject areas covered; (b) activities to be audited; (c) environmental criteria to be considered; (d) period covered by the audit. Environmental audit includes assessment of the factual data necessary to evaluate environmental performance. 4. Audit frequency The audit or audit cycle which covers all activities of the organisation shall be completed, as appropriate, at intervals of no longer than three years or four years if the derogation provided for in Article 7 applies. The frequency with which any activity is audited will vary depending on the: (a) nature, scale and complexity of the activities; (b) significance of associated environmental impacts; (c) importance and urgency of the problems detected by previous audits; (d) history of environmental problems. More complex activities with a more significant environmental impact shall be audited more frequently. The organisation shall carry out audits at least on an annual basis, as this will help to demonstrate to the organisation's management and the environmental verifier that it is in control of its significant environmental aspects. The organisation shall carry out audits regarding: (a) the environmental performance of the organisation; and (b) the organisation's compliance with applicable legal obligations relating to the environment. B. Audit activities Audit activities shall include discussions with personnel, inspection of operating conditions and equipment and reviewing of records, written procedures and other relevant documentation, with the objective of evaluating the environmental performance of the activity being audited to determine whether it meets the applicable standards, regulations or environmental objectives and targets set and whether the system in place to manage environmental responsibilities is effective and appropriate, inter alia, spot-checking of compliance with these criteria should be used to determine the effectiveness of the entire management system. The following steps, in particular, shall be included in the audit process: (a) understanding of the management systems; (b) assessing strengths and weaknesses of the management systems; (c) gathering relevant evidence; (d) evaluating audit findings; (e) preparing audit conclusions; (f) reporting audit findings and conclusions. C. Reporting audit findings and conclusions The fundamental objectives of a written audit report are: (a) to document the scope of the audit; (b) to provide the management with information on the state of compliance with the organisations\u2019 environmental policy and the environmental progress of the organisation; (c) to provide the management with information on the effectiveness and reliability of the arrangements for monitoring environmental impacts of the organisation; (d) to demonstrate the need for corrective action, where appropriate. ANNEX IV ENVIRONMENTAL REPORTING A. Introduction Environmental information shall be presented in a clear and coherent manner in electronic form or in printed form. B. Environmental statement The environmental statement shall contain at least the elements and shall meet the minimum requirements as set out below: (a) a clear and unambiguous description of the organisation registering under EMAS and a summary of its activities, products and services and its relationship to any parent organisations as appropriate; (b) the environmental policy and a brief description of the environmental management system of the organisation; (c) a description of all the significant direct and indirect environmental aspects which result in significant environmental impacts of the organisation and an explanation of the nature of the impacts as related to these aspects (Annex I.2); (d) a description of the environmental objectives and targets in relation to the significant environmental aspects and impacts; (e) a summary of the data available on the performance of the organisation against its environmental objectives and targets with respect to its significant environmental impacts. Reporting shall be on the core indicators and on other relevant existing environmental performance indicators as set out in Section C; (f) other factors regarding environmental performance including performance against legal provisions with respect to their significant environmental impacts; (g) a reference to the applicable legal requirements relating to the environment; (h) the name and accreditation or licence number of the environmental verifier and the date of validation. The updated environmental statement shall contain at least the elements and shall meet the minimum requirements as set out in points (e) to (h). C. Core indicators and other relevant existing environmental performance indicators 1. Introduction Organisations shall report, both in the environmental statement and the updated environmental statement, on the core indicators insofar as these relate to the direct environmental aspects of the organisation and other relevant existing environmental performance indicators as set out below. The reporting shall provide data on actual input/impact. If disclosure would adversely affect the confidentiality of commercial or industrial information of the organisation where such confidentiality is provided for by national or Community law to protect a legitimate economic interest, the organisation may be permitted to index this information in its reporting, e.g. by establishing a base line year (with the index number 100) from which the development of the actual input/impact would appear. The indicators shall: (a) give an accurate appraisal of the organisation's environmental performance; (b) be understandable and unambiguous; (c) allow for a year on year comparison to assess the development of the environmental performance of the organisation; (d) allow for comparison with sector, national or regional benchmarks as appropriate; (e) allow for comparison with regulatory requirements as appropriate. 2. Core indicators (a) Core indicators shall apply to all types of organisations. They focus on performance in the following key environmental areas: (i) Energy efficiency; (ii) Material efficiency; (iii) Water; (iv) Waste; (v) Biodiversity; and (vi) Emissions. Where an organisation concludes that one or more core indicators are not relevant to its significant direct environmental aspects, that organisation may not report on those core indicators. The organisation shall provide justification to that effect with reference to its environmental review. (b) Each core indicator is composed of: (i) a figure A indicating the total annual input/impact in the given field; (ii) a figure B indicating the overall annual output of the organisation; and (iii) a figure R indicating the ratio A/B. Each organisation shall report on all 3 elements for each indicator. (c) The indication of the total annual input/impact in the given field, figure A, shall be reported as follows: (i) on Energy efficiency \u2014 concerning the \u2018total direct energy use\u2019, the total annual energy consumption, expressed in MWh or GJ, \u2014 concerning the \u2018total renewable energy use\u2019, the percentage of total annual consumption of energy (electricity and heat) produced by the organisation from renewable energy sources, (ii) on Material efficiency \u2014 concerning the \u2018annual mass-flow of different materials used\u2019 (excluding energy carriers and water), expressed in tonnes, (iii) on Water \u2014 concerning the \u2018total annual water consumption\u2019, expressed in m3, (iv) on Waste \u2014 concerning the \u2018total annual generation of waste\u2019, broken down by type, expressed in tonnes, \u2014 concerning the \u2018total annual generation of hazardous waste\u2019 expressed in kilograms or tonnes, (v) on Biodiversity \u2014 concerning the \u2018use of land\u2019, expressed in m2 of built-up area, (vi) on Emissions \u2014 concerning the \u2018total annual emission of greenhouse gases\u2019, including at least emissions of CO2, CH4, N2O, HFCs, PFCs and SF6, expressed in tonnes of CO2 equivalent, \u2014 concerning the \u2018total annual air emission\u2019, including at least emissions of SO2, NOx and PM, expressed in kilograms or tonnes, In addition to the indicators defined above, an organisation may use also other indicators to express the total annual input/impact in the given field; (d) The indication of the overall annual output of the organisation, figure B, is the same for all fields, but is adapted to the different types of organisations, depending on their type of activity, and shall be reported as follows: (i) for organisations working in the production sector (industry), it shall indicate the total annual gross value-added expressed in million euro (EUR Mio) or total annual physical output expressed in tonnes or, in the case of small organisations the total annual turnover or number of employees; (ii) for organisations in the non-production sectors (administration/services), it shall relate to the size of the organisation expressed in number of employees. In addition to the indicators defined above, an organisation may use also other indicators to express its overall annual output. 3. Other relevant environmental performance indicators Each organisation shall also report annually on its performance relating to the more specific environmental aspects as identified in its environmental statement and, where available, take account of sectoral reference documents as referred to in Article 46. D. Public availability The organisation shall be able to demonstrate to the environmental verifier that anybody interested in the organisation's environmental performance can easily and freely be given access to the information required above under points B and C. The organisation shall ensure that this information is available in (one of) the official language(s) of the Member State, in which the organisation is registered, and if applicable in (one of) the official language(s) of those Member States, in which sites covered by the corporate registration are located. E. Local accountability Organisations registering under EMAS may wish to produce one corporate environmental statement, covering a number of different geographic locations. As the intention of EMAS is to ensure local accountability, organisations shall ensure that the significant environmental impacts of each site are clearly identified and reported within the corporate environmental statement. ANNEX V EMAS LOGO 1. The logo may be used in any of the 23 languages provided the following wording is used: Bulgarian : \u2018\u041f\u0440\u043e\u0432\u0435\u0440\u0435\u043d\u043e \u0443\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u0438\u0435 \u043f\u043e \u043e\u043a\u043e\u043b\u043d\u0430 \u0441\u0440\u0435\u0434\u0430\u2019 Czech : \u2018Ov\u011b\u0159en\u00fd syst\u00e9m environment\u00e1ln\u00edho \u0159\u00edzen\u00ed\u2019 Danish : \u2018Verificeret milj\u00f8ledelse\u2019 Dutch : \u2018Geverifieerd milieuzorgsysteem\u2019 English : \u2018Verified environmental management\u2019 Estonian : \u2018T\u00f5endatud keskkonnajuhtimine\u2019 Finnish : \u2018Todennettu ymp\u00e4rist\u00f6asioiden hallinta\u2019 French : \u2018Management environnemental v\u00e9rifi\u00e9\u2019 German : \u2018Gepr\u00fcftes Umweltmanagement\u2019 Greek : \u2018\u03b5\u03c0\u03b9\u03b8\u03b5\u03c9\u03c1\u03b7\u03bc\u03ad\u03bd\u03b7 \u03c0\u03b5\u03c1\u03b9\u03b2\u03b1\u03bb\u03bb\u03bf\u03bd\u03c4\u03b9\u03ba\u03ae \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u2019 Hungarian : \u2018Hiteles\u00edtett k\u00f6rnyezetv\u00e9delmi vezet\u00e9si rendszer\u2019 Italian : \u2018Gestione ambientale verificata\u2019 Irish : \u2018Bainist\u00edocht comhshaoil f\u00edoraithe\u2019 Latvian : \u2018Verific\u0113ta vides p\u0101rvald\u012bba\u2019 Lithuanian : \u2018\u012evertinta aplinkosaugos vadyba\u2019 Maltese : \u2018Immaniggjar Ambjentali Verifikat\u2019 Polish : \u2018Zweryfikowany system zarz\u0105dzania \u015brodowiskowego\u2019 Portuguese : \u2018Gest\u00e3o ambiental verificada\u2019 Romanian : \u2018Management de mediu verificat\u2019 Slovak: : \u2018Overen\u00e9 environment\u00e1lne mana\u017e\u00e9rstvo\u2019 Slovenian : \u2018Preverjen sistem ravnanja z okoljem\u2019 Spanish : \u2018Gesti\u00f3n medioambiental verificada\u2019 Swedish : \u2018Verifierat milj\u00f6ledningssystem\u2019 2. The logo shall be used either: \u2014 in three colours (Pantone No 355 Green; Pantone No 109 Yellow; Pantone No 286 Blue), \u2014 in black, \u2014 in white, or, \u2014 in a grey scale, ANNEX VI INFORMATION REQUIREMENTS FOR REGISTRATION (information to be provided when applicable) 1. ORGANISATION Name \u2026 Address \u2026 Town \u2026 Postal Code \u2026 Country/land/region/Autonomous Community \u2026 Contact person \u2026 Telephone \u2026 FAX \u2026 E-mail \u2026 Website \u2026 Public access to the environmental statement or the updated environmental statement (a) printed form \u2026 (b) electronic form \u2026 Registration number \u2026 Registration date \u2026 Suspension date of registration \u2026 Deletion date of registration \u2026 Date of the next environmental statement \u2026 Date of the next updated environmental statement \u2026 Request for derogation pursuant to Article 7 YES \u2013 NO \u2026 NACE Code of activities \u2026 Number of employees \u2026 Turnover or annual balance sheet \u2026 2. SITE Name \u2026 Address \u2026 Postal Code \u2026 Town \u2026 Country land/region/Autonomous Community \u2026 Contact person \u2026 Telephone \u2026 FAX \u2026 E-mail \u2026 Website \u2026 Public access to the environmental statement or the updated environmental statement (a) printed form \u2026 (b) electronic form \u2026 Registration number \u2026 Date of registration \u2026 Suspension date of registration \u2026 Deletion date of registration \u2026 Date of the next environmental statement \u2026 Date of the next updated environmental statement \u2026 Request for derogation pursuant to Article 7 YES \u2013 NO \u2026 NACE Code of activities \u2026 Number of Employees \u2026 Turnover/or annual balance sheet \u2026 3. ENVIRONMENTAL VERIFIER Name of environmental verifier \u2026 Address \u2026 Postal Code \u2026 Town \u2026 Country/land/region/Autonomous Community \u2026 Telephone \u2026 FAX \u2026 E-mail \u2026 Registration number of accreditation or licence \u2026 Scope of accreditation or licence (NACE Codes) \u2026 Accreditation or Licensing Body \u2026 Done at \u2026 on \u2026/\u2026/20 \u2026 Signature of the representative of the organisation \u2026 ANNEX VII ENVIRONMENTAL VERIFIER'S DECLARATION ON VERIFICATION AND VALIDATION ACTIVITIES \u2026 (name). with EMAS environmental verifier registration number \u2026 accredited or licensed for the scope \u2026 (NACE Code) declares to have verified whether the site(s) or the whole organisation as indicated in the environmental statement/updated environmental statement (1) of the organisation \u2026 (name) with registration number (if available) \u2026 meet all requirements of Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS). By signing this declaration, I declare that: \u2014 the verification and validation has been carried out in full compliance with the requirements of Regulation (EC) No 1221/2009, \u2014 the outcome of the verification and validation confirms that there is no evidence of non-compliance with applicable legal requirements relating to the environment, \u2014 the data and information of the environmental statement/the updated environmental statement (1) of the organisation/site (1) reflect a reliable, credible and correct image of all the organisations/sites (1) activities, within the scope mentioned in the environmental statement. This document is not equivalent to EMAS registration. EMAS registration can only be granted by a Competent Body under Regulation (EC) No 1221/2009. This document shall not be used as a stand-alone piece of public communication. Done at \u2026 on \u2026/\u2026/20\u2026. Signature (1) cross when non-applicable. ANNEX VIII CORRELATION TABLE Regulation (EC) No 761/2001 this Regulation Article 1(1) Article 1 Article 1(2)(a) \u2014 Article 1(2)(b) \u2014 Article 1(2)(c) \u2014 Article 1(2)(d) \u2014 Article 2(a) Article 2(1) Article 2(b) \u2014 Article 2(c) Article 2(2) Article 2(d) \u2014 Article 2(e) Article 2(9) Article 2(f) Article 2(4) Article 2(g) Article 2(8) Article 2(h) Article 2(10) Article 2(i) Article 2(11) Article 2(j) Article 2(12) Article 2(k) Article 2(13) Article 2(l) Article 2(16) Article 2(l)(i) \u2014 Article 2(l)(ii) \u2014 Article 2(m) \u2014 Article 2(n) Article 2(17) Article 2(o) Article 2(18) Article 2(p) \u2014 Article 2(q) Article 2(20) Article 2(r) \u2014 Article 2(s) first subparagraph Article 2(21) Article 2(s) second subparagraph \u2014 Article 2(t) Article 2(22) Article 2(u) \u2014 Article 3(1) \u2014 Article 3(2)(a) first subparagraph Article 4(1)(a) and (b) Article 3(2)(a) second subparagraph Article 4(3) Article 3(2)(b) Article 4(1)(c) Article 3(2)(c) Article 4(1)(d) Article 3(2)(d) Article 4(5) Article 3(2)(e) Article 5(2) first subparagraph; Article 6(3) Article 3(3)(a) Article 6(1)(a) Article 3(3)(b) first sentence Article 6(1)(b) and (c) Article 3(3)(b) second sentence Article 7(1) Article 4(1) \u2014 Article 4(2) Article 51(2) Article 4(3) \u2014 Article 4(4) \u2014 Article 4(5) first sentence Article 25(10) first subparagraph Article 4(5) second sentence Article 25(10) second subparagraph, second sentence Article 4(6) Article 41 Article 4(7) \u2014 Article 4(8) first subparagraph Article 30(1) Article 4(8) second subparagraph Article 30(3) and (5) Article 4(8) third subparagraph, first and second sentence Article 31(1) Article 4(8) third subparagraph, last sentence Article 31(2) Article 5(1) Article 11(1) first subparagraph Article 5(2) Article 11(3) Article 5(3) first sentence Article 12(1) Article 5(3) second sentence, first indent Article 12(1)(a) Article 5(3) second sentence, second indent Article 12(1)(b) Article 5(4) Article 11(1) second and third subparagraph Article 5(5) first sentence Article 16(1) Article 5(5) second sentence Article 16(3) first sentence Article 5(5) third sentence Article 17(1) Article 5(5) fourth sentence Article 16(3) second subparagraph and Article 16(4) second subparagraph Article 6(1) Article 13(1) Article 6(1), first indent Article 13(2)(a) and Article 5(2)(a) Article 6(1), second indent Article 13(2)(a) and Article 5(2)(c) Article 6(1), third indent Article 13(2)(f) and Article 5(2)(d) Article 6(1), fourth indent Article 13(2)(c) Article 6(1), second subparagraph Article 13(2) first sentence Article 6(2) Article 15(3) Article 6(3), first indent Article 15(3)(a) Article 6(3), second indent Article 15(3)(b) Article 6(3), third indent \u2014 Article 6(3), last sentence Article 15(8) Article 6(4), first paragraph Article 15(2) Article 6(4), second subparagraph Article 15(4) Article 6(5), first sentence Article 15(6) Article 6(5), second sentence Article 15(8) and (9) Article 6(6) Article 15(10) Article 7(1) Article 28(8) Article 7(2), first sentence Article 12(2) Article 7(2), second sentence Article 12(3) Article 7(3) Article 42(2)(a) Article 8(1), first sentence Article 10(1) Article 8(1), second sentence Article 10(2) Article 8(2) \u2014 Article 8(3) first subparagraph Article 10(4) Article 8(3) second subparagraph \u2014 Article 9(1) introductory sentence Article 4(3) Article 9(1)(a) Article 45(4) Article 9(1)(b) Article 45(4) Article 9(1) second subparagraph Article 45(5) Article 9(2) \u2014 Article 10(1) \u2014 Article 10(2), first subparagraph Article 38(1) and (2) Article 10(2), second subparagraph, first sentence Article 41 Article 10(2), second subparagraph, second sentence Article 47 Article 11(1), first subparagraph Article 36 Article 11(1), first indent Article 36(a) Article 11(1), second indent Article 36(c) Article 11(1), third indent Article 36(b) Article 11(1), second subparagraph, first sentence Article 37(1) Article 11(1), second subparagraph, second sentence \u2014 Article 11(1), second subparagraph, third sentence Article 37(2) Article 11(1), second subparagraph, fourth sentence Article 37(3) Article 11(2) Article 43(2) Article 11(3), first sentence Article 41(2) Article 11(3), second sentence Article 47 Article 12(1)(a) \u2014 Article 12(1)(b) Article 35(1) Article 12(1) second subparagraph \u2014 Article 12(2) Article 41(2) Article 12(3) \u2014 Article 13 Article 40(1) Article 14(1) Article 49(1) Article 14(2) \u2014 Article 14(3) \u2014 Article 15(1) Article 50 Article 15(2) Article 48 Article 15(3) \u2014 Article 16(1) Article 39(1) Article 16(2) Article 42(2) Article 17(1) \u2014 Article 17(2), (3) and (4) Article 51(2) Article 17(5) \u2014 Article 18 Article 52", "summary": "Better environmental performance: European eco-management and audit scheme (EMAS) Better environmental performance: European eco-management and audit scheme (EMAS) SUMMARY OF: Regulation (EC) No 1221/2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) WHAT IS THE AIM OF THE REGULATION? It establishes the eco-management and audit scheme (EMAS), which is a voluntary premium environmental management tool for all kinds of organisations that are willing to evaluate, report on and improve their environmental performance. KEY POINTS The EMAS registration process To receive EMAS registration, an organisation must: conduct a review of all the environmental aspects of its activities, products and services; adopt an environmental policy containing a commitment to comply with all the relevant legislation and to achieve continuous improvement of their environmental performance; develop a programme with information on specific environmental objectives and targets; establish an effective management system to achieve its environmental policy and ensure continuous improvement; carry out an environmental audit assessing the management system in place and overall conformity with its policy and programme; provide an environmental statement of its performance, set against its objectives, and the steps to be taken in the future. Validation The environmental review, management system, audit procedure and statement must be approved by an accredited environmental verifier.The validated statement is registered and made publicly available. Use of the EMAS logo An organisation successfully completing all these stages may use the EMAS logo on its letterheads and in reference to its activities and services, to demonstrate its commitment to improving its environmental performance. European Commission decisions The European Commission has adopted a series of decisions in relation to Regulation (EC) No 1221/2009. They include: Decision 2011/832/EU concerning a guide on European Union (EU) corporate registration, non-EU-country and global registration under Regulation (EC) No 1221/2009; Decision (EU) 2016/1621 on a guidance document on notification to accreditation and licensing bodies by environmental verifiers active in an EU Member State other than that where the accreditation or licence was granted under Regulation (EC) No 1221/2009; Decisions (EU) 2017/2285 and (EU) 2020/1802 amending the user\u2019s guide setting out the steps needed to participate in EMAS. The Commission has also adopted a further series of decisions on sectoral reference documents \u2013 concerning best environmental management practices, sector environmental performance indicators and benchmarks of excellence for: the retail trade sector (Decision (EU) 2015/801); the tourism sector (Decision (EU) 2016/611); the food and beverage manufacturing sector (Decision (EU) 2017/1508); the agriculture sector (Decision (EU) 2018/813); the electrical and electronic equipment manufacturing sector (Decision (EU) 2019/63); the car manufacturing sector (Decision (EU) 2019/62); the public administration sector (Decision (EU) 2019/61); the waste management sector (Decision (EU) 2020/519); the fabricated metal products manufacturing sector (Decision (EU) 2021/2053); the telecommunications and information and communication technologies services sector (Decision (EU) 2021/2054). Amendments to the legislation Regulation (EC) No 1221/2009 has been amended three times: Regulation (EU) No 517/2013 amended the regulation, adapting it to take account of Croatia becoming a member of the EU in July 2013. Regulation (EU) 2017/1505 amends Annexes I, II and III to take into account the requirements set out in the new version of the International Standard ISO 14001. Because organisations wishing to obtain or maintain both EMAS registration and ISO 14001 certification often conduct one integrated verification/certification process, coherence between the requirements of these two instruments should be kept. Regulation (EU) 2018/2026 amends Annex IV to address improvements identified in the light of experience gained in the operation of EMAS. Given the number and nature of these amendments, in the interests of clarity it was considered appropriate to replace Annex IV in its entirety. Repeal Regulation (EC) No 1221/2009 repeals Regulation (EC) No 761/2001 and Decisions 2001/681/EC and 2006/193/EC. FROM WHEN DOES THE REGULATION APPLY? It has applied since 11 January 2010. BACKGROUND For more information, see: Eco-management and audit scheme (European Commission). MAIN DOCUMENT Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission Decisions 2001/681/EC and 2006/193/EC (OJ L 342, 22.12.2009, pp. 1\u201345). Successive amendments to Regulation (EC) No 1221/2009 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Decision (EU) 2021/2053 of 8 November 2021 on the sectoral reference document on best environmental management practices, environmental performance indicators and benchmarks of excellence for the fabricated metal products manufacturing sector for the purposes of Regulation (EC) No 1221/2009 of the European Parliament and of the Council (OJ L 420, 25.11.2021, pp. 55\u201386). Commission Decision (EU) 2021/2054 of 8 November 2021 on the sectoral reference document on best environmental management practices, environmental performance indicators and benchmarks of excellence for the telecommunications and information and communication technologies (ICT) services sector for the purposes of Regulation (EC) No 1221/2009 of the European Parliament and of the Council (OJ L 420, 25.11.2021, pp. 87\u2013122). Commission Decision (EU) 2020/519 of 3 April 2020 on the sectoral reference document on best environmental management practices, sector environmental performance indicators and benchmarks of excellence for the waste management sector under Regulation (EC) No 1221/2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 115, 14.4.2020, pp. 1\u201349). Commission Decision (EU) 2019/61 of 19 December 2018 on the sectoral reference document on best environmental management practices, sector environmental performance indicators and benchmarks of excellence for the public administration sector under Regulation (EC) No 1221/2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 17, 18.1.2019, pp. 1\u201357). Commission Decision (EU) 2019/62 of 19 December 2018 on the sectoral reference document on best environmental management practices, sector environmental performance indicators and benchmarks of excellence for the car manufacturing sector under Regulation (EC) No 1221/2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 17, 18.1.2019, pp. 58\u201393). Commission Decision (EU) 2019/63 of 19 December 2018 on the sectoral reference document on best environmental management practices, sector environmental performance indicators and benchmarks of excellence for the electrical and electronic equipment manufacturing sector under Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 17, 18.1.2019, pp. 94\u2013123). Commission Decision (EU) 2018/813 of 14 May 2018 on the sectoral reference document on best environmental management practices, sector environmental performance indicators and benchmarks of excellence for the agriculture sector under Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 145, 8.6.2018, pp. 1\u201364). See consolidated version. Commission Decision (EU) 2017/2285 of 6 December 2017 amending the user\u2019s guide setting out the steps needed to participate in EMAS, under Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 328, 12.12.2017, pp. 38\u201386). Commission Decision (EU) 2017/1508 of 28 August 2017 on the reference document on best environmental management practice, sector environmental performance indicators and benchmarks of excellence for the food and beverage manufacturing sector under Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 223, 30.8.2017, pp. 1\u201335). Commission Decision (EU) 2016/1621 of 7 September 2016 adopting a guidance document on notification to accreditation and licensing bodies by environmental verifiers active in a Member State other than that where the accreditation or licence was granted under Regulation (EC) No 1221/2009 of the European Parliament and of the Council (OJ L 242, 9.9.2016, pp. 32\u201335). Commission Decision (EU) 2016/611 of 15 April 2016 on the reference document on best environmental management practice, sector environmental performance indicators and benchmarks of excellence for the tourism sector under Regulation (EC) No 1221/2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 104, 20.4.2016, pp. 27\u201369). Commission Decision (EU) 2015/801 of 20 May 2015 on reference document on best environmental management practice, sector environmental performance indicators and benchmarks of excellence for the retail trade sector under Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 127, 22.5.2015, pp. 25\u201360). Commission Decision 2013/131/EU of 4 March 2013 establishing the user\u2019s guide setting out the steps needed to participate in EMAS, under Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 76, 19.3.2013, pp. 1\u201339). See consolidated version. Commission Decision 2011/832/EU of 7 December 2011 concerning a guide on EU corporate registration, third country and global registration under Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (notified under document C(2011) 8896) (OJ L 330, 14.12.2011, pp. 25\u201338). last update 10.02.2022"}
{"article": "13.2.2008 EN Official Journal of the European Union L 39/16 REGULATION (EC) No 110/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks (3) and Commission Regulation (EEC) No 1014/90 of 24 April 1990 laying down detailed implementing rules on the definition, description and presentation of spirit drinks (4) have proved successful in regulating the spirit drinks sector. However, in the light of recent experience it is necessary to clarify the rules applicable to the definition, description, presentation and labelling of spirit drinks as well as on the protection of geographical indications of certain spirit drinks, while taking into account traditional production methods. Regulation (EEC) No 1576/89 should therefore be repealed and replaced. (2) The spirit drinks sector is important for consumers, producers and the agricultural sector in the Community. The measures applicable to the spirit drinks sector should contribute to the attainment of a high level of consumer protection, the prevention of deceptive practices and the attainment of market transparency and fair competition. By doing so, the measures should safeguard the reputation which Community spirit drinks have achieved in the Community and on the world market by continuing to take into account the traditional practices used in the production of spirit drinks as well as increased demand for consumer protection and information. Technological innovation should also be taken into account in the categories where such innovation serves to improve quality, without affecting the traditional character of the spirit drinks concerned. (3) The production of spirit drinks constitutes a major outlet for Community agricultural products. This strong link to the agricultural sector should be emphasised by the regulatory framework. (4) To ensure a more systematic approach in the legislation governing spirit drinks, this Regulation should set out clearly defined criteria for the production, description, presentation and labelling of spirit drinks as well as on the protection of geographical indications. (5) In the interests of consumers, this Regulation should apply to all spirit drinks placed on the market in the Community, whether produced in the Community or in third countries. With a view to the export of high quality spirit drinks and in order to maintain and improve the reputation of Community spirit drinks on the world market, this Regulation should also apply to such drinks produced in the Community for export. This Regulation should also apply to the use of ethyl alcohol and/or distillates of agricultural origin in the production of alcoholic beverages and to the use of the names of spirit drinks in the presentation and labelling of foodstuffs. In exceptional cases where the law of an importing third country so requires, this Regulation should allow for a derogation to be granted from the provisions of Annexes I and II to this Regulation in accordance with the regulatory procedure with scrutiny. (6) In general, this Regulation should continue to focus on definitions of spirit drinks which should be classified into categories. Those definitions should continue to respect the traditional quality practices but should be completed or updated where previous definitions were lacking or insufficient or where such definitions may be improved in the light of technological development. (7) To take into account consumer expectations about the raw materials used for vodka especially in the traditional vodka producing Member States, provision should be made for adequate information to be provided on the raw material used where the vodka is made from raw materials of agricultural origin other than cereals and/or potatoes. (8) Moreover, the ethyl alcohol used for the production of spirit drinks and other alcoholic beverages should be exclusively of agricultural origin, so as to meet consumer expectations and conform to traditional practices. This should also ensure an outlet for basic agricultural products. (9) Given the importance and complexity of the spirit drinks sector, it is appropriate to lay down specific measures on the description and presentation of spirit drinks going beyond the horizontal rules established in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (5). Those specific measures should also prevent the misuse of the term \u2018spirit drink\u2019 and the names of spirit drinks for products which do not meet the definitions set out in this Regulation. (10) While it is important to ensure that in general the maturation period or age specifies only the youngest alcoholic component, this Regulation should allow for a derogation to take account of traditional ageing processes regulated by the Member States. (11) In accordance with the Treaty, in applying a quality policy and in order to allow a high level of quality of spirit drinks and diversity in the sector, Member States should be able to adopt rules stricter than those laid down in this Regulation on the production, description, presentation and labelling of spirit drinks produced in their own territory. (12) Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (6) applies to spirit drinks. It is only necessary therefore to lay down in this Regulation rules not already provided for in that Directive. (13) It is important to have due regard to the provisions of the Agreement on Trade-related Aspects of Intellectual Property Rights (hereinafter TRIPs Agreement), and in particular Articles 22 and 23 thereof, and of the General Agreement on Tariffs and Trade, which form an integral part of the Agreement establishing the World Trade Organisation approved by Council Decision 94/800/EC (7). (14) Given that Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (8) does not apply to spirit drinks, the rules for protection of geographical indications on spirit drinks should be laid down in this Regulation. Geographical indications should be registered, identifying spirit drinks as originating in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of the spirit drink is essentially attributable to its geographical origin. (15) A non-discriminatory procedure for the registration, compliance, alteration and possible cancellation of third country and EU geographical indications in accordance with the TRIPs Agreement should be laid down in this Regulation whilst recognising the particular status of established geographical indications. (16) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9). (17) In particular, the Commission should be empowered to: grant derogations from certain parts of this Regulation where the law of an importing country so requires; lay down a maximum level of sweetening for rounding off; grant a derogation from the rules governing the indication of a maturation period or age; adopt decisions on applications for registration, on cancellation and on removal of geographical indications, as well as on the alteration of the technical file; amend the list of technical definitions and requirements, the definitions of spirit drinks classified into categories, and the list of registered geographical indications; and to derogate from the procedure governing the registration of geographical indications and the alteration of the technical file. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia by deleting some of those elements or by supplementing this Regulation with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (18) The transition from the rules provided for in Regulation (EEC) No 1576/89 to those in this Regulation could give rise to difficulties which are not dealt with in this Regulation. The measures necessary for this transition, as well as the measures required to solve practical problems specific to the spirit drinks sector, should be adopted in accordance with Decision 1999/468/EC. (19) To facilitate the transition from the rules provided for in Regulation (EEC) No 1576/89, the production of spirit drinks under that Regulation should be permitted during the first year of application of this Regulation. The marketing of existing stocks should also be foreseen until they run out, HAVE ADOPTED THIS REGULATION: CHAPTER I SCOPE, DEFINITION AND CATEGORIES OF SPIRIT DRINKS Article 1 Subject matter and scope 1. This Regulation lays down rules on the definition, description, presentation and labelling of spirit drinks as well as on the protection of geographical indications of spirit drinks. 2. This Regulation shall apply to all spirit drinks placed on the market in the Community whether produced in the Community or in third countries, as well as to those produced in the Community for export. This Regulation shall also apply to the use of ethyl alcohol and/or distillates of agricultural origin in the production of alcoholic beverages and to the use of the names of spirit drinks in the presentation and labelling of foodstuffs. 3. In exceptional cases where the law of the importing third country so requires, a derogation may be granted from the provisions of Annexes I and II in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 2 Definition of spirit drink 1. For the purpose of this Regulation, \u2018spirit drink\u2019 means an alcoholic beverage: (a) intended for human consumption; (b) possessing particular organoleptic qualities; (c) having a minimum alcoholic strength of 15 % vol.; (d) having been produced: (i) either directly: \u2014 by the distillation, with or without added flavourings, of naturally fermented products, and/or \u2014 by the maceration or similar processing of plant materials in ethyl alcohol of agricultural origin and/or distillates of agricultural origin, and/or spirit drinks within the meaning of this Regulation, and/or \u2014 by the addition of flavourings, sugars or other sweetening products listed in Annex I(3) and/or other agricultural products and/or foodstuffs to ethyl alcohol of agricultural origin and/or to distillates of agricultural origin and/or to spirit drinks, within the meaning of this Regulation, (ii) or by the mixture of a spirit drink with one or more: \u2014 other spirit drinks, and/or \u2014 ethyl alcohol of agricultural origin or distillates of agricultural origin, and/or \u2014 other alcoholic beverages, and/or \u2014 drinks. 2. However, drinks falling within CN codes 2203, 2204, 2205, 2206 and 2207 shall not be considered spirit drinks. 3. The minimum alcoholic strength provided for in paragraph 1(c) shall be without prejudice to the definition for the product in category 41 in Annex II. 4. For the purpose of this Regulation the technical definitions and requirements are laid down in Annex I. Article 3 Origin of ethyl alcohol 1. The ethyl alcohol used in the production of spirit drinks and all of their components shall not be of any origin other than agricultural, within the meaning of Annex I to the Treaty. 2. The ethyl alcohol used in the production of spirit drinks shall comply with the definition provided for in Annex I(1) to this Regulation. 3. The ethyl alcohol used to dilute or dissolve colorants, flavourings or any other authorised additives used in the preparation of spirit drinks shall be ethyl alcohol of agricultural origin. 4. Alcoholic beverages shall not contain alcohol of synthetic origin, nor other alcohol of non-agricultural origin within the meaning of Annex I to the Treaty. Article 4 Categories of spirit drinks Spirit drinks shall be classified into categories according to the definitions laid down in Annex II. Article 5 General rules concerning the categories of spirit drinks 1. Without prejudice to the specific rules laid down for each of the categories numbered 1 to 14 in Annex II, the spirit drinks defined therein shall: (a) be produced by the alcoholic fermentation and distillation exclusively obtained from the raw material provided for in the relevant definition for the spirit drink concerned; (b) have no addition of alcohol as defined in Annex I(5), diluted or not; (c) not contain added flavouring substances; (d) only contain added caramel as a means to adapt colour; (e) solely be sweetened to round off the final taste of the product, according to Annex I(3). The maximum level for the products used for rounding off listed under Annex I(3)(a) to (f) shall be decided upon in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). The particular legislation of the Member States shall be taken into account. 2. Without prejudice to the specific rules laid down for each of the categories numbered 15 to 46 in Annex II, the spirit drinks defined therein may: (a) be obtained from any agricultural raw material listed in Annex I to the Treaty; (b) have addition of alcohol as defined in Annex I(5) to this Regulation; (c) contain natural or nature-identical flavouring substances and preparations as defined in Article 1(2)(b)(i) and (ii) and in Article 1(2)(c) of Directive 88/388/EEC; (d) contain colouring as defined in Annex I(10) to this Regulation; (e) be sweetened to correspond to particular product characteristics and according to Annex I(3) to this Regulation and taking into account the particular legislation of the Member States. 3. Without prejudice to the specific rules laid down in Annex II, other spirit drinks which do not meet the requirements of categories 1 to 46 may: (a) be obtained from any agricultural raw material listed in Annex I to the Treaty and/or foodstuff suitable for human consumption; (b) have addition of alcohol as defined in Annex I(5) to this Regulation; (c) contain one or more of the flavourings as defined in Article 1(2)(a) of Directive 88/388/EEC; (d) contain colouring as defined in Annex I(10) to this Regulation; (e) be sweetened to correspond to particular product characteristics and according to Annex I(3) to this Regulation. Article 6 Member States' legislation 1. In applying a quality policy for spirit drinks which are produced on their own territory and in particular for geographical indications registered in Annex III or for the establishment of new geographical indications, Member States may lay down rules stricter than those in Annex II on production, description, presentation and labelling in so far as they are compatible with Community law. 2. Member States shall not prohibit or restrict the import, sale or consumption of spirit drinks which comply with this Regulation. CHAPTER II DESCRIPTION, PRESENTATION AND LABELLING OF SPIRIT DRINKS Article 7 Definitions For the purpose of this Regulation the terms \u2018description\u2019, \u2018presentation\u2019 and \u2018labelling\u2019 are defined in Annex I(14), (15) and (16). Article 8 Sales denomination In accordance with Article 5 of Directive 2000/13/EC, the name under which a spirit drink is sold (sales denomination) shall be subject to the provisions laid down in this Chapter. Article 9 Specific rules concerning sales denominations 1. Spirit drinks which meet the specifications for the products defined in categories 1 to 46 of Annex II shall bear in their description, presentation and labelling the sales denomination assigned therein. 2. Spirit drinks which meet the definition laid down in Article 2 but which do not meet the requirements for inclusion in categories 1 to 46 of Annex II shall bear in their description, presentation and labelling the sales denomination \u2018spirit drink\u2019. Without prejudice to paragraph 5 of this Article, that sales denomination shall not be replaced or altered. 3. Where a spirit drink meets the definition of more than one category of spirit drink in Annex II, it may be sold under one or more of the names listed for those categories in Annex II. 4. Without prejudice to paragraph 9 of this Article and to Article 10(1), the names referred to in paragraph 1 of this Article shall not be used to describe or present in any way whatsoever any drink other than the spirit drinks for which those names are listed in Annex II and registered in Annex III. 5. Sales denominations may be supplemented or replaced by a geographical indication registered in Annex III and in accordance with Chapter III, or supplemented in accordance with national provisions by another geographical indication, provided that this does not mislead the consumer. 6. The geographical indications registered in Annex III may only be supplemented either: (a) by terms already in use on 20 February 2008 for established geographical indications within the meaning of Article 20, or (b) according to the relevant technical file provided for under Article 17(1). 7. An alcoholic beverage not meeting one of the definitions listed under categories 1 to 46 of Annex II shall not be described, presented or labelled by associating words or phrases such as \u2018like\u2019, \u2018type\u2019, \u2018style\u2019, \u2018made\u2019, \u2018flavour\u2019 or any other similar terms with any of the sales denominations provided for in this Regulation and/or geographical indications registered in Annex III. 8. No trade mark, brand name or fancy name may be substituted for the sales denomination of a spirit drink. 9. The names referred to in categories 1 to 46 of Annex II may be included in a list of ingredients for foodstuffs provided that the list is in accordance with Directive 2000/13/EC. Article 10 Specific rules concerning the use of sales denominations and geographical indications 1. Without prejudice to Directive 2000/13/EC, the use of a term listed in categories 1 to 46 of Annex II, or of a geographical indication registered in Annex III in a compound term or the allusion in the presentation of a foodstuff to any of them shall be prohibited unless the alcohol originates exclusively from the spirit drink(s) referred to. 2. The use of a compound term as referred to in paragraph 1 shall also be prohibited where a spirit drink has been diluted so that the alcoholic strength is reduced to below the minimum strength specified in the definition for that spirit drink. 3. By way of derogation from paragraph 1, the provisions of this Regulation shall not affect the possible use of the terms \u2018amer\u2019 or \u2018bitter\u2019 for products not covered by this Regulation. 4. By way of derogation from paragraph 1 and in order to take account of established production methods, the compound terms listed in category 32(d) of Annex II may be used in the presentation of liqueurs produced in the Community under the conditions set out therein. Article 11 Description, presentation and labelling of mixtures 1. Where there has been addition of alcohol, as defined in Annex I(5), diluted or not, to a spirit drink listed in categories 1 to 14 of Annex II, that spirit drink shall bear the sales denomination \u2018spirit drink\u2019. It may not bear in any form a name reserved in categories 1 to 14. 2. Where a spirit drink listed in categories 1 to 46 of Annex II is mixed with: (a) one or more spirit drinks, and/or (b) one or more distillates of agricultural origin, it shall bear the sales denomination \u2018spirit drink\u2019. This sales denomination shall be shown clearly and visibly in a prominent position on the label and shall not be replaced or altered. 3. Paragraph 2 shall not apply to the description, presentation or labelling of a mixture referred to in that paragraph if it meets one of the definitions laid down in categories 1 to 46 of Annex II. 4. Without prejudice to Directive 2000/13/EC, the description, presentation or labelling of the spirit drinks resulting from the mixtures referred to in paragraph 2 of this Article may show one or more of the terms listed in Annex II only if that term does not form part of the sales denomination but is solely listed in the same visual field in the listing of all the alcoholic ingredients contained in the mixture, preceded by the term \u2018mixed spirit drink\u2019. The term \u2018mixed spirit drink\u2019 shall be labelled in uniform characters of the same font and colour as those used for the sales denomination. The characters shall be no larger than half the size of the characters used for the sales denomination. 5. For the labelling and presentation of the mixtures referred to in paragraph 2 and to which the requirement to list alcoholic ingredients under paragraph 4 applies, the proportion of each alcoholic ingredient shall be expressed as a percentage in descending order of quantities used. That proportion shall be equal to the percentage by volume of pure alcohol it represents in the total pure alcohol content by volume of the mixture. Article 12 Specific rules concerning the description, presentation and labelling of spirit drinks 1. Where the description, presentation or labelling of a spirit drink indicates the raw material used to produce the ethyl alcohol of agricultural origin, each agricultural alcohol used shall be mentioned in descending order of quantity used. 2. The description, presentation or labelling of a spirit drink may be supplemented by the term \u2018blend\u2019, \u2018blending\u2019 or \u2018blended\u2019 only where the spirit drink has undergone blending, as defined in Annex I(7). 3. Without prejudice to any derogation adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), a maturation period or age may only be specified in the description, presentation or labelling of a spirit drink where it refers to the youngest alcoholic component and provided that the spirit drink was aged under revenue supervision or supervision affording equivalent guarantees. Article 13 Prohibition of lead-based capsules or foil Spirit drinks shall not be held with a view to sale or placed on the market in containers fitted with closing devices covered by lead-based capsules or foil. Article 14 Use of language in the description, presentation and labelling of spirit drinks 1. The particulars provided for in this Regulation shall be given in one or more official languages of the European Union in such a way that the final consumer can easily understand each of those items of information, unless the consumer is provided with the information by other means. 2. The terms in italics in Annex II and the geographical indications registered in Annex III shall not be translated on the label nor in the presentation of the spirit drink. 3. In the case of spirit drinks originating in third countries, use of an official language of the third country in which the spirit drink was produced shall be authorised if the particulars provided for in this Regulation are also given in an official language of the European Union in such a way that the final consumer can easily understand each item. 4. Without prejudice to paragraph 2, in the case of spirit drinks produced in the Community and intended for export, the particulars provided for in this Regulation may be repeated in a language other than an official language of the European Union. CHAPTER III GEOGRAPHICAL INDICATIONS Article 15 Geographical indications 1. For the purpose of this Regulation a geographical indication shall be an indication which identifies a spirit drink as originating in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of that spirit drink is essentially attributable to its geographical origin. 2. The geographical indications referred to in paragraph 1 are registered in Annex III. 3. The geographical indications registered in Annex III may not become generic. Names that have become generic may not be registered in Annex III. A name that has become generic means the name of a spirit drink which, although it relates to the place or region where this product was originally produced or placed on the market, has become the common name of a spirit drink in the Community. 4. Spirit drinks bearing a geographical indication registered in Annex III shall comply with all the specifications of the technical file provided for under Article 17(1). Article 16 Protection of geographical indications Without prejudice to Article 10, the geographical indications registered in Annex III shall be protected against: (a) any direct or indirect commercial use in respect of products not covered by the registration in so far as those products are comparable to the spirit drink registered under that geographical indication or insofar as such use exploits the reputation of the registered geographical indication; (b) any misuse, imitation or evocation, even if the true origin of the product is indicated or the geographical indication is used in translation or accompanied by an expression such as \u2018like\u2019, \u2018type\u2019, \u2018style\u2019, \u2018made\u2019, \u2018flavour\u2019 or any other similar term; (c) any other false or misleading indication as to the provenance, origin, nature or essential qualities on the description, presentation or labelling of the product, liable to convey a false impression as to its origin; (d) any other practice liable to mislead the consumer as to the true origin of the product. Article 17 Registration of geographical indications 1. An application for a geographical indication to be registered in Annex III shall be submitted to the Commission in one of the official languages of the European Union or accompanied by a translation into one of those languages. That application shall be duly substantiated and shall include a technical file setting out the specifications with which the spirit drink concerned must comply. 2. With regard to geographical indications within the Community, the application referred to in paragraph 1 shall be made by the Member State of origin of the spirit drink. 3. With regard to geographical indications within a third country, the application referred to in paragraph 1 shall be sent to the Commission, either directly or via the authorities of the third country concerned, and shall include proof that the name in question is protected in its country of origin. 4. The technical file referred to in paragraph 1 shall include at least the following main specifications: (a) the name and category of the spirit drink including the geographical indication; (b) a description of the spirit drink including the principal physical, chemical and/or organoleptic characteristics of the product as well as the specific characteristics of the spirit drink as compared to the relevant category; (c) the definition of the geographical area concerned; (d) a description of the method for obtaining the spirit drink and, if appropriate, the authentic and unvarying local methods; (e) the details bearing out the link with the geographical environment or the geographical origin; (f) any requirements laid down by Community and/or national and/or regional provisions; (g) the name and contact address of the applicant; (h) any supplement to the geographical indication and/or any specific labelling rule, according to the relevant technical file. 5. The Commission shall verify, within 12 months of the date of submission of the application referred to in paragraph 1, whether that application complies with this Regulation. 6. If the Commission concludes that the application referred to in paragraph 1 complies with this Regulation, the main specifications of the technical file referred to in paragraph 4 shall be published in the Official Journal of the European Union, C Series. 7. Within six months of the date of publication of the technical file, any natural or legal person that has a legitimate interest may object to the registration of the geographical indication in Annex III on the grounds that the conditions provided for in this Regulation are not fulfilled. The objection, which must be duly substantiated, shall be submitted to the Commission in one of the official languages of the European Union or accompanied by a translation into one of those languages. 8. The Commission shall take the decision on registration of the geographical indication in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), taking into account any objection raised in accordance with paragraph 7 of this Article. That decision shall be published in the Official Journal of the European Union, C Series. Article 18 Cancellation of a geographical indication If compliance with the specifications in the technical file is no longer ensured, the Commission shall take a decision cancelling the registration in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). That decision shall be published in the Official Journal of the European Union, C Series. Article 19 Homonymous geographical indications A homonymous geographical indication meeting the requirements of this Regulation shall be registered with due regard for local and traditional usage and the actual risk of confusion, in particular: \u2014 a homonymous name which misleads the consumer into believing that products come from another territory shall not be registered even if the name is accurate as far as its wording is concerned for the actual territory, region or place of origin of the spirit drink in question, \u2014 the use of a registered homonymous geographical indication shall be subject to there being a clear distinction in practice between the homonym registered subsequently and the name already on the register, having regard to the need to treat the producers concerned in an equitable manner and not to mislead consumers. Article 20 Established geographical indications 1. For each geographical indication registered in Annex III on 20 February 2008, Member States shall submit a technical file as provided for under Article 17(1) to the Commission not later than 20 February 2015. 2. Member States shall ensure that this technical file is accessible to the public. 3. Where no technical file has been submitted to the Commission by 20 February 2015, the Commission shall remove the geographical indication from Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 21 Alteration of the technical file The procedure provided for in Article 17 shall apply mutatis mutandis where the technical file referred to in Articles 17(1) and 20(1) is to be altered. Article 22 Verification of compliance with the specifications in the technical file 1. In respect of the geographical indications within the Community, verification of compliance with the specifications in the technical file, before placing the product on the market, shall be ensured by: \u2014 one or more competent authorities referred to in Article 24(1), and/or \u2014 one or more control bodies within the meaning of Article 2 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (10), operating as a product certification body. Notwithstanding national legislation, the costs of such verification of compliance with the specifications in the technical file shall be borne by the operators subject to those controls. 2. In respect of the geographical indications within a third country, verification of compliance with the specifications in the technical file, before placing the product on the market, shall be ensured by: \u2014 one or more public authorities designated by the third country, and/or \u2014 one or more product certification bodies. 3. The product certification bodies referred to in paragraphs 1 and 2 shall comply with, and from 1 May 2010 be accredited in accordance with, European standard EN 45011 or ISO/IEC Guide 65 (General requirements for bodies operating product certification systems). 4. Where the authorities or bodies referred to in paragraphs 1 and 2 have chosen to verify compliance with the specifications in the technical file, they shall offer adequate guarantees of objectivity and impartiality and have at their disposal the qualified staff and resources necessary to carry out their functions. Article 23 Relation between trade marks and geographical indications 1. The registration of a trade mark which contains or consists of a geographical indication registered in Annex III shall be refused or invalidated if its use would lead to any of the situations referred to in Article 16. 2. With due regard to Community law, a trade mark the use of which corresponds to one of the situations referred to in Article 16 which has been applied for, registered, or established by use, if that possibility is provided for by the legislation concerned, in good faith within the territory of the Community, before either the date of protection of the geographical indication in the country of origin or before 1 January 1996, may continue to be used notwithstanding the registration of a geographical indication, provided that no grounds for its invalidity or revocation exist as specified by First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks (11) or Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade mark (12). 3. A geographical indication shall not be registered where, in the light of a trade mark's reputation and renown and the length of time it has been used in the Community, registration is liable to mislead the consumer as to the true identity of the product. CHAPTER IV GENERAL, TRANSITIONAL AND FINAL PROVISIONS Article 24 Control and protection of spirit drinks 1. Member States shall be responsible for the control of spirit drinks. They shall take the measures necessary to ensure compliance with the provisions of this Regulation and in particular they shall designate the competent authority or authorities responsible for controls in respect of the obligations established by this Regulation in accordance with Regulation (EC) No 882/2004. 2. Member States and the Commission shall communicate to each other the information necessary for the application of this Regulation. 3. The Commission, in consultation with the Member States, shall ensure the uniform application of this Regulation and if necessary shall adopt measures in accordance with the regulatory procedure referred to in Article 25(2). Article 25 Committee 1. The Commission shall be assisted by the Committee for Spirit Drinks. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Articles 5a and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 26 Amendment of the Annexes The Annexes shall be amended in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 27 Implementing measures The measures necessary for the implementation of this Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 25(2). Article 28 Transitional and other specific measures 1. In accordance with the regulatory procedure with scrutiny referred to in Article 25(3), measures to amend this Regulation shall be adopted, where appropriate: (a) to facilitate by 20 February 2011 the transition from the rules provided for in Regulation (EEC) No 1576/89 to those established by this Regulation; (b) to derogate from Articles 17 and 22 in duly justified cases; (c) to establish a Community symbol for geographical indications for the spirit drinks sector. 2. In accordance with the regulatory procedure referred to in Article 25(2), measures shall be adopted, where appropriate, to resolve specific practical problems, such as by making it obligatory, in certain cases, to state the place of manufacture on the labelling to avoid misleading the consumer and to maintain and develop Community reference methods for the analysis of spirit drinks. 3. Spirit drinks not meeting the requirements of this Regulation may continue to be produced in accordance with Regulation (EEC) No 1576/89 until 20 May 2009. Spirit drinks not meeting the requirements of this Regulation but which have been produced in accordance with Regulation (EEC) No 1576/89 prior to 20 February 2008 or until 20 May 2009 may continue to be placed on the market until stocks run out. Article 29 Repeal 1. Regulation (EEC) No 1576/89 is hereby repealed. References made to the repealed Regulation shall be construed as being made to this Regulation. 2. Commission Regulations (EEC) No 2009/92 (13), (EC) No 1267/94 (14) and (EC) No 2870/2000 (15) shall continue to apply. Article 30 Entry into force This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union. It shall apply from 20 May 2008. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 January 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J. LENAR\u010cI\u010c (1) OJ C 324, 30.12.2006, p. 12. (2) Opinion of the European Parliament of 19 June 2007 (not yet published in the Official Journal) and Council Decision of 17 December 2007. (3) OJ L 160, 12.6.1989, p. 1. Regulation as last amended by the 2005 Act of Accession. (4) OJ L 105, 25.4.1990, p. 9. Regulation as last amended by Regulation (EC) No 2140/98 (OJ L 270, 7.10.1998, p. 9). (5) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Commission Directive 2007/68/EC (OJ L 310, 28.11.2007, p. 11). (6) OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). (7) OJ L 336, 23.12.1994, p. 1. (8) OJ L 93, 31.3.2006, p. 12. Regulation as amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). (9) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (10) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1. Regulation as last amended by Council Regulation (EC) No 1791/2006. (11) OJ L 40, 11.2.1989, p. 1. Directive as amended by Council Decision 92/10/EEC (OJ L 6, 11.1.1992, p. 35). (12) OJ L 11, 14.1.1994, p. 1. Regulation as last amended by Regulation (EC) No 1891/2006 (OJ L 386, 29.12.2006, p. 14). (13) Commission Regulation (EEC) No 2009/92 of 20 July 1992 determining Community analysis methods for ethyl alcohol of agricultural origin used in the preparation of spirit drinks, aromatized wines, aromatized wine-based drinks and aromatized wine-product cocktails (OJ L 203, 21.7.1992, p. 10). (14) Commission Regulation (EC) No 1267/94 of 1 June 1994 applying the agreements between the European Union and third countries on the mutual recognition of certain spirit drinks (OJ L 138, 2.6.1994, p. 7). Regulation as amended by Regulation (EC) No 1434/97 (OJ L 196, 24.7.1997, p. 56). (15) Commission Regulation (EC) No 2870/2000 of 19 December 2000 laying down Community reference methods for the analysis of spirit drinks (OJ L 333, 29.12.2000, p. 20). Regulation as amended by Regulation (EC) No 2091/2002 (OJ L 322, 27.11.2002, p. 11). ANNEX I TECHNICAL DEFINITIONS AND REQUIREMENTS The technical definitions and requirements, as referred to in Article 2(4) and Article 7, are the following: (1) Ethyl alcohol of agricultural origin Ethyl alcohol of agricultural origin possesses the following properties: (a) organoleptic characteristics: no detectable taste other than that of the raw material; (b) minimum alcoholic strength by volume: 96,0 %; (c) maximum level of residues: (i) total acidity, expressed in grams of acetic acid per hectolitre of 100 % vol. alcohol: 1,5, (ii) esters expressed in grams of ethyl acetate per hectolitre of 100 % vol. alcohol: 1,3, (iii) aldehydes expressed in grams of acetaldehyde per hectolitre of 100 % vol. alcohol: 0,5, (iv) higher alcohols expressed in grams of methyl2 propanol1 per hectolitre of 100 % vol. alcohol: 0,5, (v) methanol expressed in grams per hectolitre of 100 % vol. alcohol: 30, (vi) dry extract expressed in grams per hectolitre of 100 % vol. alcohol: 1,5, (vii) volatile bases containing nitrogen expressed in grams of nitrogen per hectolitre of 100 % vol. alcohol: 0,1, (viii) furfural: not detectable. (2) Distillate of agricultural origin Distillate of agricultural origin means an alcoholic liquid which is obtained by the distillation, after alcoholic fermentation, of an agricultural product or products listed in Annex I to the Treaty which does not have the properties of ethyl alcohol or of a spirit drink but still retains the aroma and taste of the raw material(s) used. Where reference is made to the raw material used, the distillate must be obtained exclusively from that raw material. (3) Sweetening Sweetening means using one or more of the following products in the preparation of spirit drinks: (a) semi-white sugar, white sugar, extra-white sugar, dextrose, fructose, glucose syrup, sugar solution, invert sugar solution, invert sugar syrup, as defined in Council Directive 2001/111/EC of 20 December 2001 relating to certain sugars intended for human consumption (1); (b) rectified concentrated grape must, concentrated grape must, fresh grape must; (c) burned sugar, which is the product obtained exclusively from the controlled heating of sucrose without bases, mineral acids or other chemical additives; (d) honey as defined in Council Directive 2001/110/EC of 20 December 2001 relating to honey (2); (e) carob syrup; (f) any other natural carbohydrate substances having a similar effect to those products. (4) Mixing Mixing means combining two or more different drinks to make a new drink. (5) Addition of alcohol Addition of alcohol means the addition of ethyl alcohol of agricultural origin and/or distillates of agricultural origin to a spirit drink. (6) Addition of water In the preparation of spirit drinks, the addition of water shall be authorised, provided that the quality of the water is in conformity with Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (3) and Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (4), and that the water added does not change the nature of the product. This water may be distilled, demineralised, permuted or softened. (7) Blending Blending means combining two or more spirit drinks of the same category, distinguished only by minor differences in composition due to one or more of the following factors: (a) the method of preparation; (b) the stills employed; (c) the period of maturation or ageing; (d) the geographical area of production. The spirit drink so produced shall be of the same category of spirit drink as the original spirit drinks before blending. (8) Maturation or ageing Maturation or ageing means allowing certain reactions to develop naturally in appropriate containers, thereby giving the spirit drink in question organoleptic qualities previously absent. (9) Flavouring Flavouring means using in the preparation of a spirit drink one or more of the flavourings defined in Article 1(2)(a) of Directive 88/388/EEC. (10) Colouring Colouring means using in the preparation of a spirit drink one or more colorants, as defined in Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (5). (11) Alcoholic strength by volume Alcoholic strength by volume means the ratio of the volume of pure alcohol present in the product in question at 20 oC to the total volume of that product at the same temperature. (12) Volatile substances content Volatile substances content means the quantity of volatile substances other than ethyl alcohol and methanol contained in a spirit drink obtained exclusively by distillation, as a result solely of the distillation or redistillation of the raw materials used. (13) Place of manufacture Place of manufacture means the place or region where the stage in the production process of the finished product which conferred on the spirit drink its character and essential definitive qualities took place. (14) Description Description means the terms used on the labelling, presentation and packaging; on the documents accompanying the transport of a drink; on the commercial documents, particularly the invoices and delivery notes; and in its advertising. (15) Presentation Presentation means the terms used on the labelling and on the packaging, including in advertising and sales promotion, in images or such like, as well as on the container, including the bottle and the closure. (16) Labelling Labelling means all descriptions and other references, signs, designs or trade marks which distinguish a drink and which appear on the same container, including its sealing device or the tag attached to the container and the sheathing covering the neck of the bottle. (17) Packaging Packaging means the protective wrappings, such as papers, envelopes of all kinds, cartons and cases, used in the transport and/or sale of one or more containers. (1) OJ L 10, 12.1.2002, p. 53. (2) OJ L 10, 12.1.2002, p. 47. (3) OJ L 229, 30.8.1980, p. 1. Directive as last amended by Regulation (EC) No 1882/2003. (4) OJ L 330, 5.12.1998, p. 32. Directive as amended by Regulation (EC) No 1882/2003. (5) OJ L 237, 10.9.1994, p. 13. Directive as amended by Regulation (EC) No 1882/2003. ANNEX II SPIRIT DRINKS Categories of spirit drinks 1. Rum (a) Rum is: (i) a spirit drink produced exclusively by alcoholic fermentation and distillation, either from molasses or syrup produced in the manufacture of cane sugar or from sugar-cane juice itself and distilled at less than 96 % vol. so that the distillate has the discernible specific organoleptic characteristics of rum, or (ii) a spirit drink produced exclusively by alcoholic fermentation and distillation of sugar-cane juice which has the aromatic characteristics specific to rum and a volatile substances content equal to or exceeding 225 grams per hectolitre of 100 % vol. alcohol. This spirit may be placed on the market with the word \u2018agricultural\u2019 qualifying the sales denomination \u2018rum\u2019 accompanied by any of the geographical indications of the French Overseas Departments and the Autonomous Region of Madeira as registered in Annex III. (b) The minimum alcoholic strength by volume of rum shall be 37,5 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Rum shall not be flavoured. (e) Rum may only contain added caramel as a means to adapt colour. (f) The word \u2018traditionnel\u2019 may supplement any of the geographical indications mentioned in category 1 of Annex III where the rum is produced by distillation at less than 90 % vol., after alcoholic fermentation of alcohol-producing materials originating exclusively in the place of production considered. This rum must have a volatile substances content equal to or exceeding 225 grams per hectolitre of 100 % vol. alcohol and must not be sweetened. The use of the word \u2018traditionnel\u2019 does not prevent the use of the terms \u2018from sugar production\u2019 or \u2018agricultural\u2019 which may be added to the sales denomination \u2018rum\u2019 and to geographical indications. This provision shall not affect the use of the word \u2018traditionnel\u2019 for all products not covered by this provision, according to their own specific criteria. 2. Whisky or Whiskey (a) Whisky or whiskey is a spirit drink produced exclusively by: (i) distillation of a mash made from malted cereals with or without whole grains of other cereals, which has been: \u2014 saccharified by the diastase of the malt contained therein, with or without other natural enzymes, \u2014 fermented by the action of yeast; (ii) one or more distillations at less than 94,8 % vol., so that the distillate has an aroma and taste derived from the raw materials used, (iii) maturation of the final distillate for at least three years in wooden casks not exceeding 700 litres capacity. The final distillate, to which only water and plain caramel (for colouring) may be added, retains its colour, aroma and taste derived from the production process referred to in points (i), (ii) and (iii). (b) The minimum alcoholic strength by volume of whisky or whiskey shall be 40 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Whisky or whiskey shall not be sweetened or flavoured, nor contain any additives other than plain caramel used for colouring. 3. Grain spirit (a) Grain spirit is a spirit drink produced exclusively by the distillation of a fermented mash of whole grain cereals and having organoleptic characteristics derived from the raw materials used. (b) With the exception of \u2018Korn\u2019, the minimum alcoholic strength by volume of grain spirit shall be 35 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Grain spirit shall not be flavoured. (e) Grain spirit may only contain added caramel as a means to adapt colour. (f) For a grain spirit to bear the sales denomination \u2018grain brandy\u2019, it must have been obtained by distillation at less than 95 % vol. from a fermented mash of whole grain cereals, presenting organoleptic features deriving from the raw materials used. 4. Wine spirit (a) Wine spirit is a spirit drink: (i) produced exclusively by the distillation at less than 86 % vol. of wine or wine fortified for distillation or by the redistillation of a wine distillate at less than 86 % vol., (ii) containing a quantity of volatile substances equal to or exceeding 125 grams per hectolitre of 100 % vol. alcohol, (iii) having a maximum methanol content of 200 grams per hectolitre of 100 % vol. alcohol. (b) The minimum alcoholic strength by volume of wine spirit shall be 37,5 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Wine spirit shall not be flavoured. This shall not exclude traditional production methods. (e) Wine spirit may only contain added caramel as a means to adapt colour. (f) Where wine spirit has been matured, it may continue to be placed on the market as \u2018wine spirit\u2019 provided it has been matured for as long as, or longer than, the period stipulated for the spirit drink defined under category 5. 5. Brandy or Weinbrand (a) Brandy or Weinbrand is a spirit drink: (i) produced from wine spirit, whether or not wine distillate has been added, distilled at less than 94,8 % vol., provided that that distillate does not exceed a maximum of 50 % of the alcoholic content of the finished product, (ii) matured for at least one year in oak receptacles or for at least six months in oak casks with a capacity of less than 1 000 litres, (iii) containing a quantity of volatile substances equal to or exceeding 125 grams per hectolitre of 100 % vol. alcohol, and derived exclusively from the distillation or redistillation of the raw materials used, (iv) having a maximum methanol content of 200 grams per hectolitre of 100 % vol. alcohol. (b) The minimum alcoholic strength by volume of brandy or Weinbrand shall be 36 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Brandy or Weinbrand shall not be flavoured. This shall not exclude traditional production methods. (e) Brandy or Weinbrand may only contain added caramel as a means to adapt colour. 6. Grape marc spirit or grape marc (a) Grape marc spirit or grape marc is a spirit drink which meets the following conditions: (i) it is produced exclusively from grape marc fermented and distilled either directly by water vapour or after water has been added; (ii) a quantity of lees may be added to the grape marc that does not exceed 25 kg of lees per 100 kg of grape marc used; (iii) the quantity of alcohol derived from the lees shall not exceed 35 % of the total quantity of alcohol in the finished product; (iv) the distillation shall be carried out in the presence of the marc itself at less than 86 % vol.; (v) redistillation at the same alcoholic strength is authorised; (vi) it contains a quantity of volatile substances equal to or exceeding 140 grams per hectolitre of 100 % vol. alcohol and has a maximum methanol content of 1 000 grams per hectolitre of 100 % vol. alcohol. (b) The minimum alcoholic strength by volume of grape marc spirit or grape marc shall be 37,5 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Grape marc spirit or grape marc shall not be flavoured. This shall not exclude traditional production methods. (e) Grape marc spirit or grape marc may only contain added caramel as a means to adapt colour. 7. Fruit marc spirit (a) Fruit marc spirit is a spirit drink which meets the following conditions: (i) it is obtained exclusively by fermentation and distillation at less than 86 % vol. of fruit marc except grape marc; (ii) it contains a minimum quantity of volatile substances of 200 grams per hectolitre of 100 % vol. alcohol; (iii) the maximum methanol content shall be 1 500 grams per hectolitre of 100 % vol. alcohol; (iv) the maximum hydrocyanic acid content shall be 7 grams per hectolitre of 100 % vol. alcohol in the case of stone-fruit marc spirit; (v) redistillation at the same alcoholic strength according to (i) is authorised. (b) The minimum alcoholic strength by volume of fruit marc spirit shall be 37,5 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Fruit marc spirit shall not be flavoured. (e) Fruit marc spirit may only contain added caramel as a means to adapt colour. (f) The sales denomination shall consist of the name of the fruit followed by \u2018marc spirit\u2019. If marcs of several different fruits are used, the sales denomination shall be \u2018fruit marc spirit\u2019. 8. Raisin spirit or raisin brandy (a) Raisin spirit or raisin brandy is a spirit drink produced exclusively by the distillation of the product obtained by the alcoholic fermentation of extract of dried grapes of the \u2018Corinth Black\u2019 or Moscatel of the Alexandria varieties, distilled at less than 94,5 % vol., so that the distillate has an aroma and taste derived from the raw material used. (b) The minimum alcoholic strength by volume of raisin spirit or raisin brandy shall be 37,5 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Raisin spirit or raisin brandy shall not be flavoured. (e) Raisin spirit or raisin brandy may only contain added caramel as a means to adapt colour. 9. Fruit spirit (a) Fruit spirit is a spirit drink: (i) produced exclusively by the alcoholic fermentation and distillation of fleshy fruit or must of such fruit, berries or vegetables, with or without stones, (ii) distilled at less than 86 % vol. so that the distillate has an aroma and taste derived from the raw materials distilled, (iii) having a quantity of volatile substances equal to or exceeding 200 grams per hectolitre of 100 % vol. alcohol, (iv) in the case of stone-fruit spirits, having a hydrocyanic acid content not exceeding 7 grams per hectolitre of 100 % vol. alcohol. (b) The maximum methanol content of fruit spirit shall be 1 000 grams per hectolitre of 100 % vol. alcohol. However for the following fruit spirits the maximum methanol content shall be: (i) 1 200 grams per hectolitre of 100 % vol. alcohol obtained from the following fruits or berries: \u2014 plum (Prunus domestica L.), \u2014 mirabelle (Prunus domestica L. subsp. syriaca (Borkh.) Janch. ex Mansf.), \u2014 quetsch (Prunus domestica L.), \u2014 apple (Malus domestica Borkh.), \u2014 pear (Pyrus communis L.) except for Williams pears (Pyrus communis L. cv \u2018Williams\u2019), \u2014 raspberries (Rubus idaeus L.), \u2014 blackberries (Rubus fruticosus auct. aggr.), \u2014 apricots (Prunus armeniaca L.), \u2014 peaches (Prunus persica (L.) Batsch); (ii) 1 350 grams per hectolitre of 100 % vol. alcohol obtained from the following fruits or berries: \u2014 Williams pears (Pyrus communis L. cv \u2018Williams\u2019), \u2014 redcurrants (Ribes rubrum L.), \u2014 blackcurrants (Ribes nigrum L.), \u2014 rowanberries (Sorbus aucuparia L.), \u2014 elderberries (Sambucus nigra L.), \u2014 quinces (Cydonia oblonga Mill.), \u2014 juniper berries (Juniperus communis L. and/or Juniperus oxicedrus L.). (c) The minimum alcoholic strength by volume of fruit spirit shall be 37,5 %. (d) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (e) Fruit spirit shall not be flavoured. (f) The sales denomination of fruit spirit shall be \u2018spirit\u2019 preceded by the name of the fruit, berry or vegetable, such as: cherry spirit or kirsch, plum spirit or slivovitz, mirabelle, peach, apple, pear, apricot, fig, citrus or grape spirit or other fruit spirits. It may also be called wasser, with the name of the fruit. The name of the fruit may replace \u2018spirit\u2019 preceded by the name of the fruit, solely in the case of the following fruits: \u2014 mirabelle (Prunus domestica L. subsp. syriaca (Borkh.) Janch. ex Mansf.), \u2014 plum (Prunus domestica L.), \u2014 quetsch (Prunus domestica L.), \u2014 fruit of arbutus (Arbutus unedo L.), \u2014 \u2018Golden Delicious\u2019 apple. Should there be a risk that the final consumer does not easily understand one of these sales denominations, the labelling shall include the word \u2018spirit\u2019, possibly supplemented by an explanation. (g) The name Williams may be used only to sell pear spirit produced solely from pears of the \u2018Williams\u2019 variety. (h) Whenever two or more fruits, berries or vegetables are distilled together, the product shall be sold under the name \u2018fruit spirit\u2019 or \u2018vegetable spirit\u2019, as appropriate. The name may be supplemented by that of each fruit, berry or vegetable, in decreasing order of quantity used. 10. Cider spirit and perry spirit (a) Cider spirit and perry spirit are spirit drinks: (i) produced exclusively by the distillation at less than 86 % vol. of cider or perry so that the distillate has an aroma and taste derived from the fruits, (ii) having a quantity of volatile substances equal to or exceeding 200 grams per hectolitre of 100 % vol. alcohol, (iii) having a maximum methanol content of 1 000 grams per hectolitre of 100 % vol. alcohol. (b) The minimum alcoholic strength by volume of cider spirit and of perry spirit shall be 37,5 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Neither cider spirit nor perry spirit shall be flavoured. (e) Cider spirit and perry spirit may only contain added caramel as a means to adapt colour. 11. Honey spirit (a) Honey spirit is a spirit drink: (i) produced exclusively by fermentation and distillation of honey mash, (ii) distilled at less than 86 % vol. so that the distillate has the organoleptic characteristics derived from the raw material used. (b) The minimum alcoholic strength by volume of honey spirit shall be 35 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Honey spirit shall not be flavoured. (e) Honey spirit may only contain added caramel as a means to adapt colour. (f) Honey spirit may only be sweetened with honey. 12. Hefebrand or lees spirit (a) Hefebrand or lees spirit is a spirit drink produced exclusively by the distillation at less than 86 % vol. of lees of wine or of fermented fruit. (b) The minimum alcoholic strength by volume of Hefebrand or lees spirit shall be 38 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Hefebrand or lees spirit shall not be flavoured. (e) Hefebrand or lees spirit may only contain added caramel as a means to adapt colour. (f) The sales denomination Hefebrand or lees spirit shall be supplemented by the name of the raw material used. 13. Bierbrand or eau de vie de bi\u00e8re (a) Bierbrand or eau de vie de bi\u00e8re is a spirit drink obtained exclusively by direct distillation under normal pressure of fresh beer with an alcoholic strength by volume of less than 86 % such that the distillate obtained has organoleptic characteristics deriving from the beer. (b) The minimum alcoholic strength by volume of Bierbrand or eau de vie de bi\u00e8re shall be 38 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Bierbrand or eau de vie de bi\u00e8re shall not be flavoured. (e) Bierbrand or eau de vie de bi\u00e8re may only contain added caramel as a means to adapt colour. 14. Topinambur or Jerusalem artichoke spirit (a) Topinambur or Jerusalem artichoke spirit is a spirit drink produced exclusively by fermentation and distillation at less than 86 % vol. of Jerusalem artichoke tubers (Helianthus tuberosus L.). (b) The minimum alcoholic strength by volume of topinambur or Jerusalem artichoke spirit shall be 38 %. (c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place. (d) Topinambur or Jerusalem artichoke spirit shall not be flavoured. (e) Topinambur or Jerusalem artichoke spirit may only contain added caramel as a means to adapt colour. 15. Vodka (a) Vodka is a spirit drink produced from ethyl alcohol of agricultural origin obtained following fermentation with yeast from either: (i) potatoes and/or cereals, or (ii) other agricultural raw materials, distilled and/or rectified so that the organoleptic characteristics of the raw materials used and by-products formed in fermentation are selectively reduced. This process may be followed by redistillation and/or treatment with appropriate processing aids, including treatment with activated charcoal, to give it special organoleptic characteristics. Maximum levels of residue for ethyl alcohol of agricultural origin shall meet those laid down in Annex I, except that the methanol content shall not exceed 10 grams per hectolitre of 100 % vol. alcohol. (b) The minimum alcoholic strength by volume of vodka shall be 37,5 %. (c) The only flavourings which may be added are natural flavouring compounds present in distillate obtained from the fermented raw materials. In addition, the product may be given special organoleptic characteristics, other than a predominant flavour. (d) The description, presentation or labelling of vodka not produced exclusively from the raw material(s) listed in paragraph (a)(i) shall bear the indication \u2018produced from ...\u2019, supplemented by the name of the raw material(s) used to produce the ethyl alcohol of agricultural origin. Labelling shall be in accordance with Article 13(2) of Directive 2000/13/EC. 16. Spirit (preceded by the name of the fruit) obtained by maceration and distillation (a) Spirit (preceded by the name of the fruit) obtained by maceration and distillation is a spirit drink: (i) produced by maceration of fruit or berries listed under point (ii), whether partially fermented or unfermented, with the possible addition of a maximum of 20 litres of ethyl alcohol of agricultural origin or spirit and/or distillate deriving from the same fruit per 100 kg of fermented fruit or berries, followed by distillation at less than 86 % vol. (ii) obtained from the following fruits or berries: \u2014 blackberry (Rubus fruticosus auct. aggr.), \u2014 strawberry (Fragaria spp.), \u2014 bilberry (Vaccinium myrtillus L.), \u2014 raspberry (Rubus idaeus L.), \u2014 redcurrant (Ribes rubrum L.), \u2014 sloe (Prunus spinosa L.), \u2014 rowanberry (Sorbus aucuparia L.), \u2014 service-berry (Sorbus domestica L.), \u2014 hollyberry (Ilex cassine L.), \u2014 checkerberry (Sorbus torminalis (L.) Crantz), \u2014 elderberry (Sambucus nigra L.), \u2014 rosehip (Rosa canina L.), \u2014 blackcurrant (Ribes nigrum L.), \u2014 banana (Musa spp.), \u2014 passion fruit (Passiflora edulis Sims), \u2014 ambarella (Spondias dulcis Sol. ex Parkinson), \u2014 hog plum (Spondias mombin L.). (b) The minimum alcoholic strength by volume of a Spirit (preceded by the name of the fruit) obtained by maceration and distillation shall be 37,5 %. (c) Spirit (preceded by the name of the fruit) obtained by maceration and distillation shall not be flavoured. (d) As regards the labelling and presentation of Spirit (preceded by the name of the fruit) obtained by maceration and distillation, the wording \u2018obtained by maceration and distillation\u2019 must appear on the description, presentation or labelling in characters of the same font, size and colour and in the same visual field as the wording \u2018Spirit (preceded by the name of the fruit)\u2019 and, in the case of bottles, on the front label. 17. Geist (with the name of the fruit or the raw material used) (a) Geist (with the name of the fruit or the raw material used) is a spirit drink obtained by maceration of unfermented fruits and berries listed in category 16(a)(ii) or vegetables, nuts, or other plant materials such as herbs or rose petals in ethyl alcohol of agricultural origin, followed by distillation at less than 86 % vol. (b) The minimum alcoholic strength by volume of Geist (with the name of the fruit or the raw material used) shall be 37,5 %. (c) Geist (with the name of the fruit or the raw material used) shall not be flavoured. 18. Gentian (a) Gentian is a spirit drink produced from a distillate of gentian, itself obtained by the fermentation of gentian roots with or without the addition of ethyl alcohol of agricultural origin. (b) The minimum alcoholic strength by volume of gentian shall be 37,5 %. (c) Gentian shall not be flavoured. 19. Juniper-flavoured spirit drinks (a) Juniper-flavoured spirit drinks are spirit drinks produced by flavouring ethyl alcohol of agricultural origin and/or grain spirit and/or grain distillate with juniper (Juniperus communis L. and/or Juniperus oxicedrus L.) berries. (b) The minimum alcoholic strength by volume of juniper-flavoured spirit drinks shall be 30 %. (c) Other natural and/or nature-identical flavouring substances as defined in Article 1(2)(b)(i) and (ii) of Directive 88/388/EEC and/or flavouring preparations defined in Article 1(2)(c) of that Directive, and/or aromatic plants or parts of aromatic plants may be used in addition, but the organoleptic characteristics of juniper must be discernible, even if they are sometimes attenuated. (d) Juniper-flavoured spirit drinks may bear the sales denominations Wacholder or genebra. 20. Gin (a) Gin is a juniper-flavoured spirit drink produced by flavouring organoleptically suitable ethyl alcohol of agricultural origin with juniper berries (Juniperus communis L.). (b) The minimum alcoholic strength by volume of gin shall be 37,5 %. (c) Only natural and/or nature-identical flavouring substances as defined in Article 1(2)(b)(i) and (ii) of Directive 88/388/EEC and/or flavouring preparations as defined in Article 1(2)(c) of that Directive shall be used for the production of gin so that the taste is predominantly that of juniper. 21. Distilled gin (a) Distilled gin is: (i) a juniper-flavoured spirit drink produced exclusively by redistilling organoleptically suitable ethyl alcohol of agricultural origin of an appropriate quality with an initial alcoholic strength of at least 96 % vol. in stills traditionally used for gin, in the presence of juniper berries (Juniperus communis L.) and of other natural botanicals provided that the juniper taste is predominant, or (ii) the mixture of the product of such distillation and ethyl alcohol of agricultural origin with the same composition, purity and alcoholic strength; natural and/or nature-identical flavouring substances and/or flavouring preparations as specified in category 20(c) may also be used to flavour distilled gin. (b) The minimum alcoholic strength by volume of distilled gin shall be 37,5 %. (c) Gin obtained simply by adding essences or flavourings to ethyl alcohol of agricultural origin is not distilled gin. 22. London gin (a) London gin is a type of distilled gin: (i) obtained exclusively from ethyl alcohol of agricultural origin, with a maximum methanol content of 5 grams per hectolitre of 100 % vol. alcohol, whose flavour is introduced exclusively through the re-distillation in traditional stills of ethyl alcohol in the presence of all the natural plant materials used, (ii) the resultant distillate of which contains at least 70 % alcohol by vol., (iii) where any further ethyl alcohol of agricultural origin is added it must be consistent with the characteristics listed in Annex I(1), but with a maximum methanol content of 5 grams per hectolitre of 100 % vol. alcohol, (iv) which does not contain added sweetening exceeding 0,1 gram of sugars per litre of the final product nor colorants, (v) which does not contain any other added ingredients other than water. (b) The minimum alcoholic strength by volume of London gin shall be 37,5 %. (c) The term London gin may be supplemented by the term \u2018dry\u2019. 23. Caraway-flavoured spirit drinks (a) Caraway-flavoured spirit drinks are spirit drinks produced by flavouring ethyl alcohol of agricultural origin with caraway (Carum carvi L.). (b) The minimum alcoholic strength by volume of caraway-flavoured spirit drinks shall be 30 %. (c) Other natural and/or nature-identical flavouring substances as defined in Article 1(2)(b)(i) and (ii) of Directive 88/388/EEC and/or flavouring preparations as defined in Article 1(2)(c) of that Directive may additionally be used but there must be a predominant taste of caraway. 24. Akvavit or aquavit (a) Akvavit or aquavit is a caraway and/or dillseed-flavoured spirit drink flavoured with a distillate of plants or spices. (b) The minimum alcoholic strength by volume of akvavit or aquavit shall be 37,5 %. (c) Other natural and/or nature-identical flavouring substances as defined in Article 1(2)(b)(i) and (ii) of Directive 88/388/EEC and/or flavouring preparations as defined in Article 1(2)(c) of that Directive may additionally be used, but the flavour of these drinks is largely attributable to distillates of caraway (Carum carvi L.) and/or dill (Anethum graveolens L.) seeds, the use of essential oils being prohibited. (d) The bitter substances must not obviously dominate the taste; the dry extract content shall not exceed 1,5 grams per 100 millilitres. 25. Aniseed-flavoured spirit drinks (a) Aniseed-flavoured spirit drinks are spirit drinks produced by flavouring ethyl alcohol of agricultural origin with natural extracts of star anise (Illicium verum Hook f.), anise (Pimpinella anisum L.), fennel (Foeniculum vulgare Mill.), or any other plant which contains the same principal aromatic constituent, using one of the following processes or a combination thereof: (i) maceration and/or distillation, (ii) redistillation of the alcohol in the presence of the seeds or other parts of the plants specified above, (iii) addition of natural distilled extracts of aniseed-flavoured plants. (b) The minimum alcoholic strength by volume of aniseed-flavoured spirit drinks shall be 15 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of aniseed-flavoured spirit drinks. (d) Other natural plant extracts or aromatic seed may also be used, but the aniseed taste must remain predominant. 26. Pastis (a) Pastis is an aniseed-flavoured spirit drink which also contains natural extracts of liquorice root (Glycyrrhiza spp.), which implies the presence of the colorants known as \u2018chalcones\u2019 as well as glycyrrhizic acid, the minimum and maximum levels of which must be 0,05 and 0,5 grams per litre respectively. (b) The minimum alcoholic strength by volume of pastis shall be 40 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of pastis. (d) Pastis contains less than 100 grams of sugars per litre, expressed as invert sugar, and has a minimum and maximum anethole level of 1,5 and 2 grams per litre respectively. 27. Pastis de Marseille (a) Pastis de Marseille is a pastis with an anethole content of 2 grams per litre. (b) The minimum alcoholic strength by volume of pastis de Marseille shall be 45 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of pastis de Marseille. 28. Anis (a) Anis is an aniseed-flavoured spirit drink whose characteristic flavour is derived exclusively from anise (Pimpinella anisum L.) and/or star anise (Illicium verum Hook f.) and/or fennel (Foeniculum vulgare Mill.). (b) The minimum alcoholic strength by volume of anis shall be 35 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of anis. 29. Distilled anis (a) Distilled anis is anis which contains alcohol distilled in the presence of the seeds referred to in category 28(a), and in the case of geographical indications mastic and other aromatic seeds, plants or fruits, provided such alcohol constitutes at least 20 % of the alcoholic strength of the distilled anis. (b) The minimum alcoholic strength by volume of distilled anis shall be 35 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of distilled anis. 30. Bitter-tasting spirit drinks or bitter (a) Bitter-tasting spirit drinks or bitter are spirit drinks with a predominantly bitter taste produced by flavouring ethyl alcohol of agricultural origin with natural and/or nature-identical flavouring substances as defined in Article 1(2)(b)(i) and (ii) of Directive 88/388/EEC and/or flavouring preparations as defined in Article 1(2)(c) of that Directive. (b) The minimum alcoholic strength by volume of bitter-tasting spirit drinks or bitter shall be 15 %. (c) Bitter tasting spirit drinks or bitter may also be sold under the names \u2018amer\u2019 or \u2018bitter\u2019 with or without another term. 31. Flavoured vodka (a) Flavoured vodka is vodka which has been given a predominant flavour other than that of the raw materials. (b) The minimum alcoholic strength by volume of flavoured vodka shall be 37,5 %. (c) Flavoured vodka may be sweetened, blended, flavoured, matured or coloured. (d) Flavoured vodka may also be sold under the name of any predominant flavour with the word \u2018vodka\u2019. 32. Liqueur (a) Liqueur is a spirit drink: (i) having a minimum sugar content, expressed as invert sugar, of: \u2014 70 grams per litre for cherry liqueurs the ethyl alcohol of which consists exclusively of cherry spirit, \u2014 80 grams per litre for gentian or similar liqueurs prepared with gentian or similar plants as the sole aromatic substance, \u2014 100 grams per litre in all other cases; (ii) produced by flavouring ethyl alcohol of agricultural origin or a distillate of agricultural origin or one or more spirit drinks or a mixture thereof, sweetened and with the addition of products of agricultural origin or foodstuffs such as cream, milk or other milk products, fruit, wine or aromatised wine as defined in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine-based drinks and aromatized wine-product cocktails (1). (b) The minimum alcoholic strength by volume of liqueur shall be 15 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC and nature-identical flavouring substances and preparations as defined in Article 1(2)(b)(ii) of that Directive may be used in the preparation of liqueur. However, nature-identical flavouring substances and preparations as defined in Article 1(2)(b)(ii) of that Directive shall not be used in the preparation of the following liqueurs: (i) Fruit liqueurs: \u2014 blackcurrant, \u2014 cherry, \u2014 raspberry, \u2014 mulberry, \u2014 bilberry, \u2014 citrus fruit, \u2014 cloudberry, \u2014 arctic bramble, \u2014 cranberry, \u2014 lingonberry, \u2014 sea buckthorn, \u2014 pineapple; (ii) plant liqueurs: \u2014 mint, \u2014 gentian, \u2014 aniseed, \u2014 g\u00e9n\u00e9pi, \u2014 vulnerary. (d) The following compound terms may be used in the presentation of liqueurs produced in the Community where ethyl alcohol of agricultural origin is used to mirror established production methods: \u2014 prune brandy, \u2014 orange brandy, \u2014 apricot brandy, \u2014 cherry brandy, \u2014 solbaerrom, also called blackcurrant rum. As regards the labelling and presentation of those liqueurs, the compound term must appear on the labelling in one line in uniform characters of the same font and colour and the word \u2018liqueur\u2019 must appear in immediate proximity in characters no smaller than that font. If the alcohol does not come from the spirit drink indicated, its origin must be shown on the labelling in the same visual field as the compound term and the word \u2018liqueur\u2019 either by stating the type of agricultural alcohol or by the words \u2018agricultural alcohol\u2019 preceded on each occasion by \u2018made from\u2019 or \u2018made using\u2019. 33. Cr\u00e8me de (followed by the name of a fruit or the raw material used) (a) Spirit drinks known as Cr\u00e8me de (followed by the name of a fruit or the raw material used), excluding milk products, are liqueurs with a minimum sugar content of 250 grams per litre expressed as invert sugar. (b) The minimum alcoholic strength by volume of Cr\u00e8me de (followed by the name of a fruit or the raw material used) shall be 15 %. (c) The rules on flavouring substances and preparations for liqueurs laid down under category 32 shall apply to this spirit drink. (d) The sales denomination may be supplemented by the term \u2018liqueur\u2019. 34. Cr\u00e8me de cassis (a) Cr\u00e8me de cassis is a blackcurrant liqueur with a minimum sugar content of 400 grams per litre expressed as invert sugar. (b) The minimum alcoholic strength by volume of cr\u00e8me de cassis shall be 15 %. (c) The rules on flavouring substances and preparations for liqueurs laid down under category 32 shall apply to cr\u00e8me de cassis. (d) The sales denomination may be supplemented by the term \u2018liqueur\u2019. 35. Guignolet (a) Guignolet is a liqueur obtained by maceration of cherries in ethyl alcohol of agricultural origin. (b) The minimum alcoholic strength by volume of guignolet shall be 15 %. (c) The rules on flavouring substances and preparations for liqueurs laid down under category 32 shall apply to guignolet. (d) The sales denomination may be supplemented by the term \u2018liqueur\u2019. 36. Punch au rhum (a) Punch au rhum is a liqueur for which the alcohol content is provided exclusively by rum. (b) The minimum alcoholic strength by volume of punch au rhum shall be 15 %. (c) The rules on flavouring substances and preparations for liqueurs laid down under category 32 shall apply to punch au rhum. (d) The sales denomination may be supplemented by the term \u2018liqueur\u2019. 37. Sloe gin (a) Sloe gin is a liqueur produced by maceration of sloes in gin with the possible addition of sloe juice. (b) The minimum alcoholic strength by volume of sloe gin shall be 25 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of sloe gin. (d) The sales denomination may be supplemented by the term \u2018liqueur\u2019. 38. Sambuca (a) Sambuca is a colourless aniseed-flavoured liqueur: (i) containing distillates of anise (Pimpinella anisum L.), star anise (Illicium verum L.) or other aromatic herbs, (ii) with a minimum sugar content of 350 grams per litre expressed as invert sugar, (iii) with a natural anethole content of not less than 1 gram and not more than 2 grams per litre. (b) The minimum alcoholic strength by volume of sambuca shall be 38 %. (c) The rules on flavouring substances and preparations for liqueurs laid down under category 32 apply to sambuca. (d) The sales denomination may be supplemented by the term \u2018liqueur\u2019. 39. Maraschino, Marrasquino or Maraskino (a) Maraschino, marrasquino or maraskino is a colourless liqueur the flavour of which is given mainly by a distillate of marasca cherries or of the product obtained by macerating cherries or parts of cherries in alcohol of agricultural origin with a minimum sugar content of 250 grams per litre expressed as invert sugar. (b) The minimum alcoholic strength by volume of maraschino, marrasquino or maraskino shall be 24 %. (c) The rules on flavouring substances and preparations for liqueurs laid down under category 32 shall apply to maraschino, marrasquino or maraskino. (d) The sales denomination may be supplemented by the term \u2018liqueur\u2019. 40. Nocino (a) Nocino is a liqueur the flavour of which is given mainly by maceration and/or distillation of whole green walnuts (Juglans regia L.) with a minimum sugar content of 100 grams per litre expressed as invert sugar. (b) The minimum alcoholic strength by volume of nocino shall be 30 %. (c) The rules on flavouring substances and preparations for liqueurs laid down under category 32 shall apply to nocino. (d) The sales denomination may be supplemented by the term \u2018liqueur\u2019. 41. Egg liqueur or advocaat or avocat or advokat (a) Egg liqueur or advocaat or avocat or advokat is a spirit drink, whether or not flavoured, obtained from ethyl alcohol of agricultural origin, distillate and/or spirit, the ingredients of which are quality egg yolk, egg white and sugar or honey. The minimum sugar or honey content must be 150 grams per litre expressed as invert sugar. The minimum content of pure egg yolk must be 140 grams per litre of the final product. (b) By way of derogation from Article 2(1)(c), the minimum alcoholic strength by volume of egg liqueur or advocaat or avocat or advokat shall be 14 %. (c) Only natural or nature-identical flavouring substances and preparations as defined in Article 1(2)(b)(i) and (ii) and in Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of egg liqueur or advocaat or avocat or advokat. 42. Liqueur with egg (a) Liqueur with egg is a spirit drink, whether or not flavoured, obtained from ethyl alcohol of agricultural origin, distillate and/or spirit, the characteristic ingredients of which are quality egg yolk, egg white and sugar or honey. The minimum sugar or honey content must be 150 grams per litre expressed as invert sugar. The minimum egg yolk content must be 70 grams per litre of the final product. (b) The minimum alcoholic strength by volume of liqueur with egg shall be 15 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of liqueur with egg. 43. Mistr\u00e0 (a) Mistr\u00e0 is a colourless spirit drink flavoured with aniseed or natural anethole: (i) with an anethole content of not less than 1 gram and not more than 2 grams per litre, (ii) that may also contain a distillate of aromatic herbs, (iii) containing no added sugar. (b) The minimum alcoholic strength by volume of mistr\u00e0 shall be 40 % and the maximum alcoholic strength by volume shall be 47 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of mistr\u00e0. 44. V\u00e4kev\u00e4 gl\u00f6gi or spritgl\u00f6gg (a) V\u00e4kev\u00e4 gl\u00f6gi or spritgl\u00f6gg is a spirit drink produced by flavouring ethyl alcohol of agricultural origin with natural or nature identical aroma of cloves and/or cinnamon using one of the following processes: maceration and/or distillation, redistillation of the alcohol in the presence of parts of the plants specified above, addition of natural or nature identical flavour of cloves or cinnamon or a combination of these methods. (b) The minimum alcoholic strength by volume of v\u00e4kev\u00e4 gl\u00f6gi or spritgl\u00f6gg shall be 15 %. (c) Other natural or nature identical plant extracts or flavours in conformity with Directive 88/388/EEC may also be used, but the flavour of the specified spices must be predominant. (d) The content of wine or wine products shall not exceed 50 % of the final product. 45. Berenburg or Beerenburg (a) Berenburg or Beerenburg is a spirit drink: (i) produced using ethyl alcohol of agricultural origin, (ii) with the maceration of fruit or plants or parts thereof, (iii) containing as specific flavour distillate of gentian root (Gentiana lutea L.), of juniper berries (Juniperus communis L.) and of laurel leaves (Laurus nobilis L.), (iv) varying in colour from light to dark brown, (v) which may be sweetened to a maximum of 20 grams per litre expressed as invert sugar. (b) The minimum alcoholic strength by volume of Berenburg or Beerenburg shall be 30 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of Berenburg or Beerenburg. 46. Honey or mead nectar (a) Honey or mead nectar is a spirit drink produced by flavouring the mixture of fermented honey mash and honey distillate and/or ethyl alcohol of agricultural origin, which contains at least 30 % vol. of fermented honey mash. (b) The minimum alcoholic strength by volume of honey or mead nectar shall be 22 %. (c) Only natural flavouring substances and preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of honey or mead nectar provided that the honey taste is predominant. (d) Honey or mead nectar may be sweetened only with honey. Other spirit drinks 1. Rum-Verschnitt is produced in Germany and obtained by mixing rum and alcohol, whereby a minimum proportion of 5 % of the alcohol contained in the final product must come from rum. The minimum alcoholic strength by volume of Rum-Verschnitt shall be 37,5 %. As regards the labelling and presentation of the product Rum-Verschnitt the word Verschnitt must appear on the description, presentation and labelling in characters of the same font, size and colour as, and on the same line as, the word \u2018Rum\u2019 and, in the case of bottles, on the front label. Where this product is sold outside the German market, its alcoholic composition must appear on the label. 2. Slivovice is produced in the Czech Republic and obtained by the addition to the plum distillate, before the final distillation, of a maximum proportion of 30 % by volume of ethyl alcohol of agricultural origin. This product must be described as \u2018spirit drink\u2019 and may also use the name slivovice in the same visual field on the front label. If this Czech slivovice is placed on the market in the Community, its alcoholic composition must appear on the label. This provision is without prejudice to the use of the name slivovice for fruit spirits according to category 9. (1) OJ L 149, 14.6.1991, p. 1. Regulation as last amended by the 2005 Act of Accession. ANNEX III GEOGRAPHICAL INDICATIONS Product category Geographical indication Country of origin (the precise geographical origin is described in the technical file) 1. Rum Rhum de la Martinique France Rhum de la Guadeloupe France Rhum de la R\u00e9union France Rhum de la Guyane France Rhum de sucrerie de la Baie du Galion France Rhum des Antilles fran\u00e7aises France Rhum des d\u00e9partements fran\u00e7ais d'outre-mer France Ron de M\u00e1laga Spain Ron de Granada Spain Rum da Madeira Portugal 2. Whisky/Whiskey Scotch Whisky United Kingdom (Scotland) Irish Whiskey/Uisce Beatha Eireannach/Irish Whisky (1) Ireland Whisky espa\u00f1ol Spain Whisky breton/Whisky de Bretagne France Whisky alsacien/Whisky d'Alsace France 3. Grain spirit Eau-de-vie de seigle de marque nationale luxembourgeoise Luxembourg Korn/Kornbrand Germany, Austria, Belgium (German-speaking Community) M\u00fcnsterl\u00e4nder Korn/Kornbrand Germany Sendenhorster Korn/Kornbrand Germany Bergischer Korn/Kornbrand Germany Emsl\u00e4nder Korn/Kornbrand Germany Hasel\u00fcnner Korn/Kornbrand Germany Hasetaler Korn/Kornbrand Germany Saman\u0117 Lithuania 4. Wine spirit Eau-de-vie de Cognac France Eau-de-vie des Charentes France Eau-de-vie de Jura France Cognac France (The denomination \u2018Cognac\u2019 may be supplemented by the following terms: \u2014 Fine France \u2014 Grande Fine Champagne France \u2014 Grande Champagne France \u2014 Petite Fine Champagne France \u2014 Petite Champagne France \u2014 Fine Champagne France \u2014 Borderies France \u2014 Fins Bois France \u2014 Bons Bois) France Fine Bordeaux France Fine de Bourgogne France Armagnac France Bas-Armagnac France Haut-Armagnac France Armagnac-T\u00e9nar\u00e8ze France Blanche Armagnac France Eau-de-vie de vin de la Marne France Eau-de-vie de vin originaire d'Aquitaine France Eau-de-vie de vin de Bourgogne France Eau-de-vie de vin originaire du Centre-Est France Eau-de-vie de vin originaire de Franche-Comt\u00e9 France Eau-de-vie de vin originaire du Bugey France Eau-de-vie de vin de Savoie France Eau-de-vie de vin originaire des Coteaux de la Loire France Eau-de-vie de vin des C\u00f4tes-du-Rh\u00f4ne France Eau-de-vie de vin originaire de Provence France Eau-de-vie de Faug\u00e8res/Faug\u00e8res France Eau-de-vie de vin originaire du Languedoc France Aguardente de Vinho Douro Portugal Aguardente de Vinho Ribatejo Portugal Aguardente de Vinho Alentejo Portugal Aguardente de Vinho da Regi\u00e3o dos Vinhos Verdes Portugal Aguardente de Vinho da Regi\u00e3o dos Vinhos Verdes de Alvarinho Portugal Aguardente de Vinho Lourinh\u00e3 Portugal \u0421\u0443\u043d\u0433\u0443\u0440\u043b\u0430\u0440\u0441\u043a\u0430 \u0433\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u0413\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0421\u0443\u043d\u0433\u0443\u0440\u043b\u0430\u0440\u0435/Sungurlarska grozdova rakya/Grozdova rakya from Sungurlare Bulgaria \u0421\u043b\u0438\u0432\u0435\u043d\u0441\u043a\u0430 \u043f\u0435\u0440\u043b\u0430 (\u0421\u043b\u0438\u0432\u0435\u043d\u0441\u043a\u0430 \u0433\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u0413\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0421\u043b\u0438\u0432\u0435\u043d)/Slivenska perla (Slivenska grozdova rakya/Grozdova rakya from Sliven) Bulgaria \u0421\u0442\u0440\u0430\u043b\u0434\u0436\u0430\u043d\u0441\u043a\u0430 \u041c\u0443\u0441\u043a\u0430\u0442\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u041c\u0443\u0441\u043a\u0430\u0442\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0421\u0442\u0440\u0430\u043b\u0434\u0436\u0430/Straldjanska Muscatova rakya/Muscatova rakya from Straldja Bulgaria \u041f\u043e\u043c\u043e\u0440\u0438\u0439\u0441\u043a\u0430 \u0433\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u0413\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u041f\u043e\u043c\u043e\u0440\u0438\u0435/Pomoriyska grozdova rakya/Grozdova rakya from Pomorie Bulgaria \u0420\u0443\u0441\u0435\u043d\u0441\u043a\u0430 \u0431\u0438\u0441\u0435\u0440\u043d\u0430 \u0433\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u0411\u0438\u0441\u0435\u0440\u043d\u0430 \u0433\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0420\u0443\u0441\u0435/Russenska biserna grozdova rakya/Biserna grozdova rakya from Russe Bulgaria \u0411\u0443\u0440\u0433\u0430\u0441\u043a\u0430 \u041c\u0443\u0441\u043a\u0430\u0442\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u041c\u0443\u0441\u043a\u0430\u0442\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0411\u0443\u0440\u0433\u0430\u0441/Bourgaska Muscatova rakya/Muscatova rakya from Bourgas Bulgaria \u0414\u043e\u0431\u0440\u0443\u0434\u0436\u0430\u043d\u0441\u043a\u0430 \u043c\u0443\u0441\u043a\u0430\u0442\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u041c\u0443\u0441\u043a\u0430\u0442\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0414\u043e\u0431\u0440\u0443\u0434\u0436\u0430/Dobrudjanska muscatova rakya/muscatova rakya from Dobrudja Bulgaria \u0421\u0443\u0445\u0438\u043d\u0434\u043e\u043b\u0441\u043a\u0430 \u0433\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u0413\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0421\u0443\u0445\u0438\u043d\u0434\u043e\u043b/Suhindolska grozdova rakya/Grozdova rakya from Suhindol Bulgaria \u041a\u0430\u0440\u043b\u043e\u0432\u0441\u043a\u0430 \u0433\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u0413\u0440\u043e\u0437\u0434\u043e\u0432\u0430 \u0420\u0430\u043a\u0438\u044f \u043e\u0442 \u041a\u0430\u0440\u043b\u043e\u0432\u043e/Karlovska grozdova rakya/Grozdova Rakya from Karlovo Bulgaria Vinars T\u00e2rnave Romania Vinars Vaslui Romania Vinars Murfatlar Romania Vinars Vrancea Romania Vinars Segarcea Romania 5. Brandy/Weinbrand Brandy de Jerez Spain Brandy del Pened\u00e9s Spain Brandy italiano Italy Brandy \u0391\u03c4\u03c4\u03b9\u03ba\u03ae\u03c2/Brandy of Attica Greece Brandy \u03a0\u03b5\u03bb\u03bf\u03c0\u03bf\u03bd\u03bd\u03ae\u03c3\u03bf\u03c5/Brandy of the Peloponnese Greece Brandy \u039a\u03b5\u03bd\u03c4\u03c1\u03b9\u03ba\u03ae\u03c2 \u0395\u03bb\u03bb\u03ac\u03b4\u03b1\u03c2/Brandy of central Greece Greece Deutscher Weinbrand Germany Wachauer Weinbrand Austria Weinbrand D\u00fcrnstein Austria Pf\u00e4lzer Weinbrand Germany Karpatsk\u00e9 brandy \u0161peci\u00e1l Slovakia Brandy fran\u00e7ais/Brandy de France France 6. Grape marc spirit Marc de Champagne/Eau-de-vie de marc de Champagne France Marc d'Aquitaine/Eau-de-vie de marc originaire d'Aquitaine France Marc de Bourgogne/Eau-de-vie de marc de Bourgogne France Marc du Centre-Est/Eau-de-vie de marc originaire du Centre-Est France Marc de Franche-Comt\u00e9/Eau-de-vie de marc originaire de Franche-Comt\u00e9 France Marc du Bugey/Eau-de-vie de marc originaire de Bugey France Marc de Savoie/Eau-de-vie de marc originaire de Savoie France Marc des C\u00f4teaux de la Loire/Eau-de-vie de marc originaire des Coteaux de la Loire France Marc des C\u00f4tes-du-Rh\u00f4ne/Eau-de-vie de marc des C\u00f4tes du Rh\u00f4ne France Marc de Provence/Eau-de-vie de marc originaire de Provence France Marc du Languedoc/Eau-de-vie de marc originaire du Languedoc France Marc d'Alsace Gew\u00fcrztraminer France Marc de Lorraine France Marc d'Auvergne France Marc du Jura France Aguardente Bagaceira Bairrada Portugal Aguardente Bagaceira Alentejo Portugal Aguardente Bagaceira da Regi\u00e3o dos Vinhos Verdes Portugal Aguardente Bagaceira da Regi\u00e3o dos Vinhos Verdes de Alvarinho Portugal Orujo de Galicia Spain Grappa Italy Grappa di Barolo Italy Grappa piemontese/Grappa del Piemonte Italy Grappa lombarda/Grappa di Lombardia Italy Grappa trentina/Grappa del Trentino Italy Grappa friulana/Grappa del Friuli Italy Grappa veneta/Grappa del Veneto Italy S\u00fcdtiroler Grappa/Grappa dell'Alto Adige Italy Grappa siciliana/Grappa di Sicilia Italy Grappa di Marsala Italy \u03a4\u03c3\u03b9\u03ba\u03bf\u03c5\u03b4\u03b9\u03ac/Tsikoudia Greece \u03a4\u03c3\u03b9\u03ba\u03bf\u03c5\u03b4\u03b9\u03ac \u039a\u03c1\u03ae\u03c4\u03b7\u03c2/Tsikoudia of Crete Greece \u03a4\u03c3\u03af\u03c0\u03bf\u03c5\u03c1\u03bf/Tsipouro Greece \u03a4\u03c3\u03af\u03c0\u03bf\u03c5\u03c1\u03bf \u039c\u03b1\u03ba\u03b5\u03b4\u03bf\u03bd\u03af\u03b1\u03c2/Tsipouro of Macedonia Greece \u03a4\u03c3\u03af\u03c0\u03bf\u03c5\u03c1\u03bf \u0398\u03b5\u03c3\u03c3\u03b1\u03bb\u03af\u03b1\u03c2/Tsipouro of Thessaly Greece \u03a4\u03c3\u03af\u03c0\u03bf\u03c5\u03c1\u03bf \u03a4\u03c5\u03c1\u03bd\u03ac\u03b2\u03bf\u03c5/Tsipouro of Tyrnavos Greece Eau-de-vie de marc de marque nationale luxembourgeoise Luxembourg \u0396\u03b9\u03b2\u03b1\u03bd\u03af\u03b1/\u03a4\u03b6\u03b9\u03b2\u03b1\u03bd\u03af\u03b1/\u0396\u03b9\u03b2\u03ac\u03bd\u03b1/Zivania Cyprus T\u00f6rk\u00f6lyp\u00e1linka Hungary 9. Fruit spirit Schwarzw\u00e4lder Kirschwasser Germany Schwarzw\u00e4lder Mirabellenwasser Germany Schwarzw\u00e4lder Williamsbirne Germany Schwarzw\u00e4lder Zwetschgenwasser Germany Fr\u00e4nkisches Zwetschgenwasser Germany Fr\u00e4nkisches Kirschwasser Germany Fr\u00e4nkischer Obstler Germany Mirabelle de Lorraine France Kirsch d'Alsace France Quetsch d'Alsace France Framboise d'Alsace France Mirabelle d'Alsace France Kirsch de Fougerolles France Williams d'Orl\u00e9ans France S\u00fcdtiroler Williams/Williams dell'Alto Adige Italy S\u00fcdtiroler Aprikot/Aprikot dell'Alto Adige Italy S\u00fcdtiroler Marille/Marille dell'Alto Adige Italy S\u00fcdtiroler Kirsch/Kirsch dell'Alto Adige Italy S\u00fcdtiroler Zwetschgeler/Zwetschgeler dell'Alto Adige Italy S\u00fcdtiroler Obstler/Obstler dell'Alto Adige Italy S\u00fcdtiroler Gravensteiner/Gravensteiner dell'Alto Adige Italy S\u00fcdtiroler Golden Delicious/Golden Delicious dell'Alto Adige Italy Williams friulano/Williams del Friuli Italy Sliwovitz del Veneto Italy Sliwovitz del Friuli-Venezia Giulia Italy Sliwovitz del Trentino-Alto Adige Italy Distillato di mele trentino/Distillato di mele del Trentino Italy Williams trentino/Williams del Trentino Italy Sliwovitz trentino/Sliwovitz del Trentino Italy Aprikot trentino/Aprikot del Trentino Italy Medronho do Algarve Portugal Medronho do Bu\u00e7aco Portugal Kirsch Friulano/Kirschwasser Friulano Italy Kirsch Trentino/Kirschwasser Trentino Italy Kirsch Veneto/Kirschwasser Veneto Italy Aguardente de p\u00eara da Lous\u00e3 Portugal Eau-de-vie de pommes de marque nationale luxembourgeoise Luxembourg Eau-de-vie de poires de marque nationale luxembourgeoise Luxembourg Eau-de-vie de kirsch de marque nationale luxembourgeoise Luxembourg Eau-de-vie de quetsch de marque nationale luxembourgeoise Luxembourg Eau-de-vie de mirabelle de marque nationale luxembourgeoise Luxembourg Eau-de-vie de prunelles de marque nationale luxembourgeoise Luxembourg Wachauer Marillenbrand Austria Szatm\u00e1ri Szilvap\u00e1linka Hungary Kecskem\u00e9ti Barackp\u00e1linka Hungary B\u00e9k\u00e9si Szilvap\u00e1linka Hungary Szabolcsi Almap\u00e1linka Hungary G\u00f6nci Barackp\u00e1linka Hungary P\u00e1linka Hungary, Austria (for apricot spirits solely produced in the L\u00e4nder of: Nieder\u00f6sterreich, Burgenland, Steiermark, Wien) Bo\u0161\u00e1cka slivovica Slovakia Brinjevec Slovenia Dolenjski sadjevec Slovenia \u0422\u0440\u043e\u044f\u043d\u0441\u043a\u0430 \u0441\u043b\u0438\u0432\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u0421\u043b\u0438\u0432\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0422\u0440\u043e\u044f\u043d/Troyanska slivova rakya/Slivova rakya from Troyan Bulgaria \u0421\u0438\u043b\u0438\u0441\u0442\u0440\u0435\u043d\u0441\u043a\u0430 \u043a\u0430\u0439\u0441\u0438\u0435\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u041a\u0430\u0439\u0441\u0438\u0435\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0421\u0438\u043b\u0438\u0441\u0442\u0440\u0430/Silistrenska kaysieva rakya/Kaysieva rakya from Silistra Bulgaria \u0422\u0435\u0440\u0432\u0435\u043b\u0441\u043a\u0430 \u043a\u0430\u0439\u0441\u0438\u0435\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u041a\u0430\u0439\u0441\u0438\u0435\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u0422\u0435\u0440\u0432\u0435\u043b/Tervelska kaysieva rakya/Kaysieva rakya from Tervel Bulgaria \u041b\u043e\u0432\u0435\u0448\u043a\u0430 \u0441\u043b\u0438\u0432\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f/\u0421\u043b\u0438\u0432\u043e\u0432\u0430 \u0440\u0430\u043a\u0438\u044f \u043e\u0442 \u041b\u043e\u0432\u0435\u0447/Loveshka slivova rakya/Slivova rakya from Lovech Bulgaria P\u0103linc\u0103 Romania \u0162uic\u0103 Zetea de Medie\u015fu Aurit Romania \u0162uic\u0103 de Valea Milcovului Romania \u0162uic\u0103 de Buz\u0103u Romania \u0162uic\u0103 de Arge\u015f Romania \u0162uic\u0103 de Zal\u0103u Romania \u0162uic\u0103 Ardeleneasc\u0103 de Bistri\u0163a Romania Horinc\u0103 de Maramure\u015f Romania Horinc\u0103 de C\u0103m\u00e2rzana Romania Horinc\u0103 de Seini Romania Horinc\u0103 de Chioar Romania Horinc\u0103 de L\u0103pu\u015f Romania Tur\u0163 de Oa\u015f Romania Tur\u0163 de Maramure\u015f Romania 10. Cider spirit and perry spirit Calvados France Calvados Pays d'Auge France Calvados Domfrontais France Eau-de-vie de cidre de Bretagne France Eau-de-vie de poir\u00e9 de Bretagne France Eau-de-vie de cidre de Normandie France Eau-de-vie de poir\u00e9 de Normandie France Eau-de-vie de cidre du Maine France Aguardiente de sidra de Asturias Spain Eau-de-vie de poir\u00e9 du Maine France 15. Vodka Svensk Vodka/Swedish Vodka Sweden Suomalainen Vodka/Finsk Vodka/Vodka of Finland Finland Polska W\u00f3dka/Polish Vodka Poland Laugar\u00edcio vodka Slovakia Originali lietuvi\u0161ka degtin\u0117/Original Lithuanian vodka Lithuania Herbal vodka from the North Podlasie Lowland aromatised with an extract of bison grass/W\u00f3dka zio\u0142owa z Niziny P\u00f3\u0142nocnopodlaskiej aromatyzowana ekstraktem z trawy \u017cubrowej Poland Latvijas Dzidrais Latvia R\u012bgas Degv\u012bns Latvia Estonian vodka Estonia 17. Geist Schwarzw\u00e4lder Himbeergeist Germany 18. Gentian Bayerischer Gebirgsenzian Germany S\u00fcdtiroler Enzian/Genziana dell'Alto Adige Italy Genziana trentina/Genziana del Trentino Italy 19. Juniper-flavoured spirit drinks Geni\u00e8vre/Jenever/Genever Belgium, The Netherlands, France (D\u00e9partements Nord (59) and Pas-de-Calais (62)), Germany (German Bundesl\u00e4nder Nordrhein-Westfalen and Niedersachsen) Geni\u00e8vre de grains, Graanjenever, Graangenever Belgium, The Netherlands, France (D\u00e9partements Nord (59) and Pas-de-Calais (62)) Jonge jenever, jonge genever Belgium, The Netherlands Oude jenever, oude genever Belgium, The Netherlands Hasseltse jenever/Hasselt Belgium (Hasselt, Zonhoven, Diepenbeek) Balegemse jenever Belgium (Balegem) O' de Flander-Oost-Vlaamse Graanjenever Belgium (Oost-Vlaanderen) Peket-Pek\u00eat/P\u00e8ket-P\u00e8k\u00e8t de Wallonie Belgium (R\u00e9gion wallonne) Geni\u00e8vre Flandres Artois France (D\u00e9partements Nord (59) and Pas-de-Calais (62)) Ostfriesischer Korngenever Germany Steinh\u00e4ger Germany Plymouth Gin United Kingdom Gin de Mah\u00f3n Spain Vilniaus D\u017einas/Vilnius Gin Lithuania Spi\u0161sk\u00e1 borovi\u010dka Slovakia Slovensk\u00e1 borovi\u010dka Juniperus Slovakia Slovensk\u00e1 borovi\u010dka Slovakia Inoveck\u00e1 borovi\u010dka Slovakia Liptovsk\u00e1 borovi\u010dka Slovakia 24. Akvavit/aquavit Dansk Akvavit/Dansk Aquavit Denmark Svensk Aquavit/Svensk Akvavit/Swedish Aquavit Sweden 25. Aniseed-flavoured spirit drinks An\u00eds espa\u00f1ol Spain An\u00eds Paloma Monforte del Cid Spain Hierbas de Mallorca Spain Hierbas Ibicencas Spain \u00c9vora anisada Portugal Cazalla Spain Chinch\u00f3n Spain Oj\u00e9n Spain Rute Spain Jane\u017eevec Slovenia 29. Distilled Anis Ouzo/O\u03cd\u03b6\u03bf Cyprus, Greece \u039f\u03cd\u03b6\u03bf \u039c\u03c5\u03c4\u03b9\u03bb\u03ae\u03bd\u03b7\u03c2/Ouzo of Mitilene Greece \u039f\u03cd\u03b6\u03bf \u03a0\u03bb\u03c9\u03bc\u03b1\u03c1\u03af\u03bf\u03c5/Ouzo of Plomari Greece \u039f\u03cd\u03b6\u03bf \u039a\u03b1\u03bb\u03b1\u03bc\u03ac\u03c4\u03b1\u03c2/Ouzo of Kalamata Greece \u039f\u03cd\u03b6\u03bf \u0398\u03c1\u03ac\u03ba\u03b7\u03c2/Ouzo of Thrace Greece \u039f\u03cd\u03b6\u03bf \u039c\u03b1\u03ba\u03b5\u03b4\u03bf\u03bd\u03af\u03b1\u03c2/Ouzo of Macedonia Greece 30. Bitter-tasting spirit drinks/bitter Dem\u00e4novka bylinn\u00e1 hork\u00e1 Slovakia Rheinberger Kr\u00e4uter Germany Trejos devynerios Lithuania Slovenska travarica Slovenia 32. Liqueur Berliner K\u00fcmmel Germany Hamburger K\u00fcmmel Germany M\u00fcnchener K\u00fcmmel Germany Chiemseer Klosterlik\u00f6r Germany Bayerischer Kr\u00e4uterlik\u00f6r Germany Irish Cream Ireland Palo de Mallorca Spain Ginjinha portuguesa Portugal Licor de Singeverga Portugal Mirto di Sardegna Italy Liquore di limone di Sorrento Italy Liquore di limone della Costa d'Amalfi Italy Genep\u00ec del Piemonte Italy Genep\u00ec della Valle d'Aosta Italy Benediktbeurer Klosterlik\u00f6r Germany Ettaler Klosterlik\u00f6r Germany Ratafia de Champagne France Ratafia catalana Spain Anis portugu\u00eas Portugal Suomalainen Marjalik\u00f6\u00f6ri/Suomalainen Hedelm\u00e4lik\u00f6\u00f6ri Finsk B\u00e4rlik\u00f6r/Finsk Fruktlik\u00f6r/ Finnish berry liqueur/Finnish fruit liqueur Finland Grossglockner Alpenbitter Austria Mariazeller Magenlik\u00f6r Austria Mariazeller Jagasaftl Austria Puchheimer Bitter Austria Steinfelder Magenbitter Austria Wachauer Marillenlik\u00f6r Austria J\u00e4gertee/Jagertee/Jagatee Austria H\u00fcttentee Germany Alla\u017eu \u0136imelis Latvia \u010cepkeli\u0173 Lithuania Dem\u00e4novka Bylinn\u00fd Lik\u00e9r Slovakia Polish Cherry Poland Karlovarsk\u00e1 Ho\u0159k\u00e1 Czech Republic Pelinkovec Slovenia Blutwurz Germany Cantueso Alicantino Spain Licor caf\u00e9 de Galicia Spain Licor de hierbas de Galicia Spain G\u00e9n\u00e9pi des Alpes/Genep\u00ec degli Alpi France, Italy \u039c\u03b1\u03c3\u03c4\u03af\u03c7\u03b1 \u03a7\u03af\u03bf\u03c5/Masticha of Chios Greece \u039a\u03af\u03c4\u03c1\u03bf \u039d\u03ac\u03be\u03bf\u03c5/Kitro of Naxos Greece \u039a\u03bf\u03c5\u03bc\u03ba\u03bf\u03c5\u03ac\u03c4 \u039a\u03ad\u03c1\u03ba\u03c5\u03c1\u03b1\u03c2/Koum Kouat of Corfu Greece \u03a4\u03b5\u03bd\u03c4\u03bf\u03cd\u03c1\u03b1/Tentoura Greece Poncha da Madeira Portugal 34. Cr\u00e8me de cassis Cassis de Bourgogne France Cassis de Dijon France Cassis de Saintonge France Cassis du Dauphin\u00e9 France Cassis de Beaufort Luxembourg 40. Nocino Nocino di Modena Italy Orehovec Slovenia Other spirit drinks Pommeau de Bretagne France Pommeau du Maine France Pommeau de Normandie France Svensk Punsch/Swedish Punch Sweden Pachar\u00e1n navarro Spain Pachar\u00e1n Spain Inl\u00e4nderrum Austria B\u00e4rwurz Germany Aguardiente de hierbas de Galicia Spain Aperitivo Caf\u00e9 de Alcoy Spain Herbero de la Sierra de Mariola Spain K\u00f6nigsberger B\u00e4renfang Germany Ostpreu\u00dfischer B\u00e4renfang Germany Ronmiel Spain Ronmiel de Canarias Spain Geni\u00e8vre aux fruits/Vruchtenjenever/Jenever met vruchten/Fruchtgenever Belgium, The Netherlands, France (D\u00e9partements Nord (59) and Pas-de-Calais (62)), Germany (German Bundesl\u00e4nder Nordrhein-Westfalen and Niedersachsen) Doma\u010di rum Slovenia Irish Poteen/Irish Poit\u00edn Ireland Trauktin\u0117 Lithuania Trauktin\u0117 Palanga Lithuania Trauktin\u0117 Dainava Lithuania (1) The geographical indication Irish Whiskey/Uisce Beatha Eireannach/Irish Whisky covers whisky/whiskey produced in Ireland and Northern Ireland.", "summary": "Geographical origin of spirit drinks Geographical origin of spirit drinks In order to protect consumers and develop the spirit drinks* sector, the European Union has created a legal framework that ensures uniform EU-wide rules on the marketing of spirit drinks. ACT Regulation (EC) No 110/2008 of the European Parliament and the Council of 15 January 2008 on the definition, description, presentation, labelling and protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 SUMMARY WHAT DOES THIS REGULATION DO? It sets the rules regarding the definition, description, presentation and labelling of spirit drinks, and also the protection of geographical indications. It applies to all spirit drinks, whether produced in EU or non-EU countries. KEY POINTS Annex II of this regulation highlights 46 different categories for spirit drinks with different qualities the spirit drink must have in order to be included in any given category. If the spirit drink contains qualities from several categories, then it may be sold under one or more of the category denominations. The general rules concerning the presentation and the labelling of foodstuffs apply to spirit drinks. However, specific labelling and presentation rules are laid down in this regulation, such as labelling the raw materials used, drawing the parameters of the term \u2018blend\u2019, indicating the maturation period, banning lead-based capsules from being used as closing devices and ensuring that labelling is given in one or more of the EU's official languages. The geographical indication identifies a spirit drink as originating within the territory of a country where a given quality, reputation or other characteristic is attributable to its geographical origin. In order to register a geographical indication, both EU countries and non-EU countries must submit an application to the European Commission. The application must include a technical file containing information such as the description of the spirit drink, the definition of the geographical area, a description of the method for obtaining the spirit drink, any requirements laid down by European, national or regional provisions, and the name and contact address of the applicant. If the spirit drink no longer possesses the characteristics described in the technical file, the European Commission may cancel the registration of a geographical indication. KEY TERMS * Spirit drinks: alcoholic drinks intended for human consumption. By definition, they possess particular organoleptic qualities and have a minimum alcoholic strength of 15 %. They are produced by distillation, by maceration or by the addition of flavourings, or by mixing a spirit drink with another drink, ethyl alcohol of agricultural origin or certain distillates. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 110/2008 20.2.2008 - OJ L 39, 13.2.2008, pp. 16-54 Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 1334/2008 20.1.2009 - OJ L 354, 31.12.2008, pp. 34-50 Successive amendments and corrections to Regulation (EC) No 110/2008 have been incorporated in the basic text. This consolidated version is for reference purposes only. RELATED ACTS Commission Regulation (EC) No 936/2009 of 7 October 2009 applying the agreements between the European Union and third countries on the mutual recognition of certain spirit drinks (OJ L 264, 8.10.2009, pp. 5-6) last update 02.10.2015"}
{"article": "9.4.2008 EN Official Journal of the European Union L 97/72 REGULATION (EC) No 300/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), in the light of the joint text approved by the Conciliation Committee on 16 January 2008. Whereas: (1) In order to protect persons and goods within the European Union, acts of unlawful interference with civil aircraft that jeopardise the security of civil aviation should be prevented by establishing common rules for safeguarding civil aviation. This objective should be achieved by setting common rules and common basic standards on aviation security as well as mechanisms for monitoring compliance. (2) It is desirable, in the interests of civil aviation security generally, to provide the basis for a common interpretation of Annex 17 to the Chicago Convention on International Civil Aviation of 7 December 1944. (3) Regulation (EC) No 2320/2002 of the European Parliament and of the Council of 16 December 2002 establishing common rules in the field of civil aviation security (3) was adopted as a result of the events of 11 September 2001 in the United States. A common approach is needed in the field of civil aviation security and consideration should be given to the most effective means of offering assistance following terrorist acts that have a major impact in the transport field. (4) The content of Regulation (EC) No 2320/2002 should be revised in the light of the experience gained, and the Regulation itself should be repealed and replaced by this Regulation seeking the simplification, harmonisation and clarification of the existing rules and the improvement of the levels of security. (5) Given the need for more flexibility in adopting security measures and procedures in order to meet evolving risk assessments and to allow new technologies to be introduced, this Regulation should lay down the basic principles of what has to be done in order to safeguard civil aviation against acts of unlawful interference without going into the technical and procedural details of how they are to be implemented. (6) This Regulation should apply to airports serving civil aviation located in the territory of a Member State, to operators providing services at such airports and to entities providing goods and/or services to or through such airports. (7) Without prejudice to the Convention on offences and certain other acts committed on board aircraft, Tokyo, 1963, the Convention for the suppression of unlawful seizure of aircraft, The Hague, 1970, and the Convention for the suppression of unlawful acts against the safety of civil aviation, Montreal, 1971, this Regulation should also cover security measures that apply on board an aircraft, or during a flight, of Community air carriers. (8) Each Member State retains the competence to decide whether to deploy in-flight security officers on aircraft registered in that Member State and on flights of air carriers licensed by it as well as to ensure, in accordance with paragraph 4.7.7 of Annex 17 to the Chicago Convention on International Civil Aviation and under the terms of that Convention, that such officers are government personnel who are specially selected and trained, taking into account the required security and safety aspects on board an aircraft. (9) The various types of civil aviation do not necessarily present the same level of threat. In setting common basic standards on aviation security, the size of the aircraft, the nature of the operation and/or the frequency of operations at airports should be taken into account with a view to permitting the grant of derogations. (10) Member States should also be allowed, on the basis of a risk assessment, to apply more stringent measures than those laid down in this Regulation. (11) Third countries may require the application of measures that differ from those laid down in this Regulation in respect of flights from an airport in a Member State to, or over, that third country. However, without prejudice to any bilateral agreements to which the Community is a party, it should be possible for the Commission to examine the measures required by the third country. (12) Even though, within a single Member State, there may be two or more bodies involved in aviation security, each Member State should designate a single authority responsible for the coordination and monitoring of the implementation of security standards. (13) In order to define responsibilities for the implementation of the common basic standards on aviation security and to describe what measures are required by operators and other entities for this purpose, each Member State should draw up a national civil aviation security programme. Furthermore, each airport operator, air carrier and entity implementing aviation security standards should draw up, apply and maintain a security programme in order to comply both with this Regulation and with whichever national civil aviation security programme is applicable. (14) In order to monitor compliance with this Regulation and with the national civil aviation security programme, each Member State should draw up and ensure the implementation of a national programme to check the level and quality of civil aviation security. (15) In order to monitor the application by Member States of this Regulation, and also to make recommendations to improve aviation security, the Commission should conduct inspections, including unannounced inspections. (16) As a general rule, the Commission should publish measures that have a direct impact on passengers. Implementing acts setting out common measures and procedures for the implementation of the common basic standards on aviation security which contain sensitive security information, together with Commission inspection reports and the answers of the appropriate authorities should be regarded as EU classified information within the meaning of Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal rules of procedure (4). Those items should not be published and should be made available only to those operators and entities with a legitimate interest. (17) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5). (18) In particular, the Commission should be empowered to adopt general measures amending non-essential elements of the common basic standards by supplementing them, set criteria allowing Member States both to derogate from the common basic standards and to adopt alternative security measures, and adopt specifications for national quality control programmes. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (19) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of common rules for safeguarding civil aviation. (20) The goal of \u2018one-stop security\u2019 for all flights within the European Union should be advanced. (21) Furthermore, it should not be necessary to rescreen passengers or their baggage arriving on flights from third countries that have aviation security standards equivalent to those laid down by this Regulation. Therefore, without prejudice to the right of each Member State to apply more stringent measures, or to the respective competences of the Community and Member States, decisions of the Commission, and, where necessary, agreements between the Community and third countries, which recognise that the security standards applied in the third country are equivalent to the common standards, should be encouraged since these further one-stop security. (22) This Regulation is without prejudice to the application of rules on aviation safety, including those relating to the transport of dangerous goods. (23) Penalties should be provided for infringements of the provisions of this Regulation. Those penalties, which may be of a civil or administrative nature, should be effective, proportionate and dissuasive. (24) The Ministerial Statement on Gibraltar Airport, agreed in Cordoba on 18 September 2006 during the first Ministerial meeting of the Forum of Dialogue on Gibraltar, will replace the Joint Declaration on Gibraltar Airport made in London on 2 December 1987, and full compliance with it will be deemed to constitute compliance with the 1987 Declaration. (25) Since the objectives of this Regulation, namely to safeguard civil aviation against acts of unlawful interference and to provide a basis for a common interpretation of Annex 17 to the Chicago Convention on International Civil Aviation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Regulation, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: Article 1 Objectives 1. This Regulation establishes common rules to protect civil aviation against acts of unlawful interference that jeopardise the security of civil aviation. It also provides the basis for a common interpretation of Annex 17 to the Chicago Convention on International Civil Aviation. 2. The means of achieving the objectives set out in paragraph 1 shall be: (a) the setting of common rules and common basic standards on aviation security; (b) mechanisms for monitoring compliance. Article 2 Scope 1. This Regulation shall apply to the following: (a) all airports or parts of airports located in the territory of a Member State that are not exclusively used for military purposes; (b) all operators, including air carriers, providing services at airports referred to in point (a); (c) all entities applying aviation security standards that operate from premises located inside or outside airport premises and provide goods and/or services to or through airports referred to in point (a). 2. The application of this Regulation to the airport of Gibraltar is understood to be without prejudice to the respective legal positions of the Kingdom of Spain and the United Kingdom with regard to the dispute over sovereignty over the territory in which the airport is situated. Article 3 Definitions For the purposes of this Regulation: 1. \u2018civil aviation\u2019 means any air operation carried out by civil aircraft, excluding operations carried out by State aircraft referred to in Article 3 of the Chicago Convention on International Civil Aviation; 2. \u2018aviation security\u2019 means the combination of measures and human and material resources intended to safeguard civil aviation against acts of unlawful interference that jeopardise the security of civil aviation; 3. \u2018operator\u2019 means a person, organisation or enterprise engaged, or offering to engage, in an air transport operation; 4. \u2018air carrier\u2019 means an air transport undertaking holding a valid operating licence or equivalent; 5. \u2018Community air carrier\u2019 means an air carrier holding a valid operating licence granted by a Member State in accordance with Council Regulation (EEC) No 2407/92 of 23 July 1992 on licensing of air carriers (6); 6. \u2018entity\u2019 means a person, organisation or enterprise, other than an operator; 7. \u2018prohibited articles\u2019 means weapons, explosives or other dangerous devices, articles or substances that may be used to commit an act of unlawful interference that jeopardises the security of civil aviation; 8. \u2018screening\u2019 means the application of technical or other means which are intended to identify and/or detect prohibited articles; 9. \u2018security control\u2019 means the application of means by which the introduction of prohibited articles may be prevented; 10. \u2018access control\u2019 means the application of means by which the entry of unauthorised persons or unauthorised vehicles, or both, may be prevented; 11. \u2018airside\u2019 means the movement area of an airport, adjacent terrain and buildings or portions thereof, access to which is restricted; 12. \u2018landside\u2019 means those parts of an airport, adjacent terrain and buildings or portions thereof that are not airside; 13. \u2018security restricted area\u2019 means that area of airside where, in addition to access being restricted, other aviation security standards are applied; 14. \u2018demarcated area\u2019 means an area that is separated by means of access control either from security restricted areas, or, if the demarcated area itself is a security restricted area, from other security restricted areas of an airport; 15. \u2018background check\u2019 means a recorded check of a person\u2019s identity, including any criminal history, as part of the assessment of an individual\u2019s suitability for unescorted access to security restricted areas; 16. \u2018transfer passengers, baggage, cargo or mail\u2019 means passengers, baggage, cargo or mail departing on an aircraft other than that on which they arrived; 17. \u2018transit passengers, baggage, cargo or mail\u2019 means passengers, baggage, cargo or mail departing on the same aircraft as that on which they arrived; 18. \u2018potentially disruptive passenger\u2019 means a passenger who is either a deportee, a person deemed to be inadmissible for immigration reasons or a person in lawful custody; 19. \u2018cabin baggage\u2019 means baggage intended for carriage in the cabin of an aircraft; 20. \u2018hold baggage\u2019 means baggage intended for carriage in the hold of an aircraft; 21. \u2018accompanied hold baggage\u2019 means baggage, carried in the hold of an aircraft, which has been checked in for a flight by a passenger travelling on that same flight; 22. \u2018air carrier mail\u2019 means mail whose origin and destination are both an air carrier; 23. \u2018air carrier materials\u2019 means materials either whose origin and destination are both an air carrier or that are used by an air carrier; 24. \u2018mail\u2019 means dispatches of correspondence and other items, other than air carrier mail, tendered by and intended for delivery to postal services in accordance with the rules of the Universal Postal Union; 25. \u2018cargo\u2019 means any property intended for carriage on an aircraft, other than baggage, mail, air carrier mail, air carrier materials and in-flight supplies; 26. \u2018regulated agent\u2019 means an air carrier, agent, freight forwarder or any other entity who ensures security controls in respect of cargo or mail; 27. \u2018known consignor\u2019 means a consignor who originates cargo or mail for its own account and whose procedures meet common security rules and standards sufficient to allow carriage of cargo or mail on any aircraft; 28. \u2018account consignor\u2019 means a consignor who originates cargo or mail for its own account and whose procedures meet common security rules and standards sufficient to allow carriage of that cargo on all-cargo aircraft or mail on all-mail aircraft; 29. \u2018aircraft security check\u2019 means an inspection of those parts of the interior of the aircraft to which passengers may have had access, together with an inspection of the hold of the aircraft in order to detect prohibited articles and unlawful interferences with the aircraft; 30. \u2018aircraft security search\u2019 means an inspection of the interior and accessible exterior of the aircraft in order to detect prohibited articles and unlawful interferences that jeopardise the security of the aircraft; 31. \u2018in-flight security officer\u2019 means a person who is employed by a state to travel on an aircraft of an air carrier licensed by it with the purpose of protecting that aircraft and its occupants against acts of unlawful interference that jeopardise the security of the flight. Article 4 Common basic standards 1. The common basic standards for safeguarding civil aviation against acts of unlawful interference that jeopardise the security of civil aviation shall be as laid down in the Annex. Additional common basic standards not foreseen at the entry into force of this Regulation should be added to the Annex in accordance with the procedure referred to in Article 251 of the Treaty. 2. General measures, designed to amend non-essential elements of the common basic standards referred to in paragraph 1 by supplementing them, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). These general measures shall concern: (a) methods of screening allowed; (b) categories of articles that may be prohibited; (c) as regards access control, grounds for granting access to airside and security restricted areas; (d) methods allowed for the examination of vehicles, aircraft security checks and aircraft security searches; (e) criteria for recognising the equivalence of security standards of third countries; (f) conditions under which cargo and mail shall be screened or subjected to other security controls, as well as the process for the approval or designation of regulated agents, known consignors and account consignors; (g) conditions under which air carrier mail and air carrier materials shall be screened or subjected to other security controls; (h) conditions under which in-flight supplies and airport supplies shall be screened or subjected to other security controls, as well as the process for the approval or designation of regulated suppliers and known suppliers; (i) criteria for defining critical parts of security restricted areas; (j) criteria for staff recruitment and methods of training; (k) conditions under which special security procedures or exemptions from security controls may be applied; and (l) any general measures designed to amend non-essential elements of the common basic standards referred to in paragraph 1 by supplementing them not foreseen at the date of entry into force of this Regulation. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 19(4). 3. Detailed measures for the implementation of the common basic standards referred to in paragraph 1 and the general measures referred to in paragraph 2 shall be laid down in accordance with the regulatory procedure referred to in Article 19(2). These shall include: (a) requirements and procedures for screening; (b) a list of prohibited articles; (c) requirements and procedures for access control; (d) requirements and procedures for the examination of vehicles, aircraft security checks and aircraft security searches; (e) decisions to recognise the equivalence of security standards applied in a third country; (f) as regards cargo and mail, procedures for the approval or designation of, and the obligations to be fulfilled by, regulated agents, known consignors and account consignors; (g) requirements and procedures for security controls of air carrier mail and air carrier materials; (h) as regards in-flight supplies and airport supplies, procedures for the approval or designation of, and the obligations to be fulfilled by, regulated suppliers and known suppliers; (i) definition of critical parts of security restricted areas; (j) staff recruitment and training requirements; (k) special security procedures or exemptions from security controls; (l) technical specifications and procedures for approval and use of security equipment; and (m) requirements and procedures concerning potentially disruptive passengers. 4. The Commission shall, by amending this Regulation through a decision in accordance with the regulatory procedure with scrutiny referred to in Article 19(3), set criteria to allow Member States to derogate from the common basic standards referred to in paragraph 1 and to adopt alternative security measures that provide an adequate level of protection on the basis of a local risk assessment. Such alternative measures shall be justified by reasons relating to the size of the aircraft, or by reasons relating to the nature, scale or frequency of operations or of other relevant activities. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 19(4). The Member States shall inform the Commission of such measures. 5. Member States shall ensure the application in their territory of the common basic standards referred to in paragraph 1. Where a Member State has reason to believe that the level of aviation security has been compromised through a security breach, it shall ensure that appropriate and prompt action is taken to rectify that breach and ensure the continuing security of civil aviation. Article 5 Security costs Subject to the relevant rules of Community law, each Member State may determine in which circumstances, and the extent to which, the costs of security measures taken under this Regulation to protect civil aviation against acts of unlawful interference should be borne by the State, the airport entities, air carriers, other responsible agencies, or users. If appropriate, and in conformity with Community law, Member States may contribute with users to the costs of more stringent security measures taken under this Regulation. As far as may be practicable, any charges or transfers of security costs shall be directly related to the costs of providing the security services concerned and shall be designed to recover no more than the relevant costs involved. Article 6 More stringent measures applied by Member States 1. Member States may apply more stringent measures than the common basic standards referred to in Article 4. In doing so, they shall act on the basis of a risk assessment and in compliance with Community law. \u03a4hose measures shall be relevant, objective, non-discriminatory and proportional to the risk that is being addressed. 2. Member States shall inform the Commission of such measures as soon as possible after their application. Upon reception of such information, the Commission shall transmit this information to the other Member States. 3. Member States are not required to inform the Commission where the measures concerned are limited to a given flight on a specific date. Article 7 Security measures required by third countries 1. Without prejudice to any bilateral agreements to which the Community is a party, a Member State shall notify the Commission of measures required by a third country if they differ from the common basic standards referred to in Article 4 in respect of flights from an airport in a Member State to, or over, that third country. 2. At the request of the Member State concerned or on its own initiative, the Commission shall examine the application of any measures notified under paragraph 1 and may, in accordance with the regulatory procedure referred to in Article 19(2), draw up an appropriate response to the third country concerned. 3. Paragraphs 1 and 2 shall not apply if: (a) the Member State concerned applies the measures concerned in accordance with Article 6; or (b) the requirement of the third country is limited to a given flight on a specific date. Article 8 Cooperation with the International Civil Aviation Organisation Without prejudice to Article 300 of the Treaty, the Commission may conclude a Memorandum of Understanding concerning audits with the International Civil Aviation Organisation (ICAO) in order to avoid duplicate monitoring of Member States\u2019 compliance with Annex 17 to the Chicago Convention on International Civil Aviation. Article 9 Appropriate authority Where, within a single Member State, two or more bodies are involved in civil aviation security, that Member State shall designate a single authority (hereinafter referred to as the appropriate authority) to be responsible for the coordination and monitoring of the implementation of the common basic standards referred to in Article 4. Article 10 National civil aviation security programme 1. Every Member State shall draw up, apply and maintain a national civil aviation security programme. That programme shall define responsibilities for the implementation of the common basic standards referred to in Article 4 and shall describe the measures required by operators and entities for this purpose. 2. The appropriate authority shall make available in writing on a \u2018need to know\u2019 basis the appropriate parts of its national civil aviation security programme to operators and entities which it deems to have a legitimate interest. Article 11 National quality control programme 1. Every Member State shall draw up, apply and maintain a national quality control programme. That programme shall enable the Member State to check the quality of civil aviation security in order to monitor compliance both with this Regulation and with its national civil aviation security programme. 2. The specifications for the national quality control programme shall be adopted by amending this Regulation through the addition of an annex in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 19(4). The programme shall allow for the swift detection and correction of deficiencies. It shall also provide that all airports, operators and entities responsible for the implementation of aviation security standards that are located in the territory of the Member State concerned shall be regularly monitored directly by, or under the supervision of, the appropriate authority. Article 12 Airport security programme 1. Every airport operator shall draw up, apply and maintain an airport security programme. That programme shall describe the methods and procedures which are to be followed by the airport operator in order to comply both with this Regulation and with the national civil aviation security programme of the Member State in which the airport is located. The programme shall include internal quality control provisions describing how compliance with these methods and procedures is to be monitored by the airport operator. 2. The airport security programme shall be submitted to the appropriate authority, which may take further action if appropriate. Article 13 Air carrier security programme 1. Every air carrier shall draw up, apply and maintain an air carrier security programme. That programme shall describe the methods and procedures which are to be followed by the air carrier in order to comply both with this Regulation and with the national civil aviation security programme of the Member State from which it provides services. The programme shall include internal quality control provisions describing how compliance with these methods and procedures is to be monitored by the air carrier. 2. Upon request, the air carrier security programme shall be submitted to the appropriate authority, which may take further action if appropriate. 3. Where a Community air carrier security programme has been validated by the appropriate authority of the Member State granting the operating licence, the air carrier shall be recognised by all other Member States as having fulfilled the requirements of paragraph 1. This is without prejudice to a Member State\u2019s right to request from any air carrier details of its implementation of: (a) the security measures applied by that Member State under Article 6; and/or (b) local procedures that are applicable at the airports served. Article 14 Entity security programme 1. Every entity required under the national civil aviation security programme referred to in Article 10 to apply aviation security standards shall draw up, apply and maintain a security programme. That programme shall describe the methods and procedures which are to be followed by the entity in order to comply with the national civil aviation security programme of the Member State in respect of its operations in that Member State. The programme shall include internal quality control provisions describing how compliance with these methods and procedures is to be monitored by the entity itself. 2. Upon request, the security programme of the entity applying aviation security standards shall be submitted to the appropriate authority, which may take further action if appropriate. Article 15 Commission inspections 1. The Commission, acting in cooperation with the appropriate authority of the Member State concerned, shall conduct inspections, including inspections of airports, operators and entities applying aviation security standards, in order to monitor the application by Member States of this Regulation and, as appropriate, to make recommendations to improve aviation security. For this purpose, the appropriate authority shall inform the Commission in writing of all airports in its territory serving civil aviation other than those covered by Article 4(4). The procedures for conducting Commission inspections shall be adopted in accordance with the regulatory procedure referred to in Article 19(2). 2. Commission inspections of airports, operators and entities applying aviation security standards shall be unannounced. The Commission shall in good time before an inspection inform the Member State concerned thereof. 3. Each Commission inspection report shall be communicated to the appropriate authority of the Member State concerned, which shall, in its answer, set out the measures taken to remedy any identified deficiencies. The report, together with the answer of the appropriate authority, shall subsequently be communicated to the appropriate authority of the other Member States. Article 16 Annual report Every year the Commission shall present a report to the European Parliament, the Council and the Member States informing them of the application of this Regulation and of its impact on improving aviation security. Article 17 Stakeholders\u2019 Advisory Group Without prejudice to the role of the Committee referred to in Article 19, the Commission shall establish a Stakeholders\u2019 Advisory Group on Aviation Security, composed of European representative organisations engaged in, or directly affected by, aviation security. The role of this group shall be solely to advise the Commission. The Committee referred to in Article 19 shall keep the Stakeholders\u2019 Advisory Group informed during the entire regulatory process. Article 18 Dissemination of information As a general rule, the Commission shall publish measures that have a direct impact on passengers. However, the following documents shall be regarded as EU classified information within the meaning of Decision 2001/844/EC, ECSC, Euratom: (a) measures and procedures as referred to in Articles 4(3), 4(4), 6(1) and 7(1), if containing sensitive security information; (b) the Commission inspection reports and the answers of the appropriate authorities referred to in Article 15(3). Article 19 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. Where reference is made to this paragraph, Article 5a(1), (2), (4), and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 20 Agreements between the Community and third countries When appropriate, and in conformity with Community law, agreements recognising that the security standards applied in a third country are equivalent to Community standards could be envisaged in aviation agreements between the Community and a third country in accordance with Article 300 of the Treaty, in order to advance the goal of \u2018one-stop security\u2019 for all flights between the European Union and third countries. Article 21 Penalties Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Article 22 Commission report on financing The Commission will report, no later than 31 December 2008, on the principles of the financing of the costs of civil aviation security measures. That report will consider what steps need to be taken in order to ensure that security charges are used exclusively to meet security costs, and to improve the transparency of such charges. The report will also address the principles necessary to safeguard undistorted competition between airports and between air carriers, and the different methods to ensure consumer protection as regards the distribution of the costs of security measures between taxpayers and users. The Commission report will be accompanied, if appropriate, by a legislative proposal. Article 23 Repeal Regulation (EC) No 2320/2002 is hereby repealed. Article 24 Entry into force 1. This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. 2. It shall apply as from the date specified in the implementing rules adopted in accordance with the procedures referred to in Article 4(2) and (3), but not later than 24 months after the entry into force of this Regulation. 3. By way of exception to paragraph 2, Articles 4(2), 4(3), 4(4), 8, 11(2), 15(1) second subparagraph, 17, 19 and 22 shall apply from the date of entry into force of this Regulation. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 March 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J. LENAR\u010cI\u010c (1) OJ C 185, 8.8.2006, p. 17. (2) Opinion of the European Parliament of 15 June 2006 (OJ C 300 E, 9.12.2006, p. 463), Council Common Position of 11 December 2006 (OJ C 70 E, 27.3.2007, p. 21) and Position of the European Parliament of 25 April 2007 (not yet published in the Official Journal), Legislative Resolution of the European Parliament of 11 March 2008 (not yet published in the Official Journal) and Council Decision of 4 March 2008. (3) OJ L 355, 30.12.2002, p. 1. Regulation as amended by Regulation (EC) No 849/2004 (OJ L 158, 30.4.2004, p. 1, corrected by OJ L 229, 29.6.2004, p. 3). (4) OJ L 317, 3.12.2001, p. 1. Decision as last amended by Decision 2006/548/EC, Euratom (OJ L 215, 5.8.2006, p. 38). (5) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (6) OJ L 240, 24.8.1992, p. 1. ANNEX COMMON BASIC STANDARDS FOR SAFEGUARDING CIVIL AVIATION AGAINST ACTS OF UNLAWFUL INTERFERENCE (ARTICLE 4) 1. AIRPORT SECURITY 1.1. Airport planning requirements 1. When designing and constructing new airport facilities or altering existing airport facilities, requirements for the implementation of the common basic standards set out in this Annex and its implementing acts shall be fully taken into account. 2. At airports the following areas shall be established: (a) landside; (b) airside; (c) security restricted areas; and (d) critical parts of security restricted areas. 1.2. Access control 1. Access to airside shall be restricted in order to prevent unauthorised persons and vehicles from entering these areas. 2. Access to security restricted areas shall be controlled in order to ensure that no unauthorised persons and vehicles enter these areas. 3. Persons and vehicles may be granted access to airside and security restricted areas only if they fulfil the required security conditions. 4. Persons, including flight crew members, shall have successfully completed a background check before either a crew identification card or an airport identification card authorising unescorted access to security restricted areas is issued to them. 1.3. Screening of persons other than passengers and items carried 1. Persons other than passengers, together with items carried, shall be screened on a continuous random basis upon entering security restricted areas in order to prevent prohibited articles from being introduced into these areas. 2. All persons other than passengers, together with items carried, shall be screened upon entering critical parts of security restricted areas in order to prevent prohibited articles from being introduced into these parts. 1.4. Examination of vehicles Vehicles entering a security restricted area shall be examined in order to prevent prohibited articles from being introduced into these areas. 1.5. Surveillance, patrols and other physical controls There shall be surveillance, patrols and other physical controls at airports and, where appropriate, in adjacent areas with public access, in order to identify suspicious behaviour of persons, to identify vulnerabilities which could be exploited to carry out an act of unlawful interference and to deter persons from committing such acts. 2. DEMARCATED AREAS OF AIRPORTS Aircraft parked in demarcated areas of airports to which alternative measures referred to in Article 4(4) apply, shall be separated from aircraft to which the common basic standards apply in full, in order to ensure that security standards applied to aircraft, passengers, baggage, cargo and mail of the latter are not compromised. 3. AIRCRAFT SECURITY 1. Before departure, an aircraft shall be subjected to an aircraft security check or aircraft security search in order to ensure that no prohibited articles are present on board. An aircraft in transit may be subjected to other appropriate measures. 2. Every aircraft shall be protected from unauthorised interference. 4. PASSENGERS AND CABIN BAGGAGE 4.1. Screening of passengers and cabin baggage 1. All originating, transfer and transit passengers and their cabin baggage shall be screened in order to prevent prohibited articles from being introduced into security restricted areas and on board an aircraft. 2. Transfer passengers and their cabin baggage may be exempted from screening, if: (a) they arrive from a Member State, unless the Commission or that Member State has provided information that those passengers and their cabin baggage cannot be considered as having been screened to the common basic standards; or (b) they arrive from a third country where the security standards applied are recognised as equivalent to the common basic standards in accordance with the regulatory procedure referred to in Article 19(2). 3. Transit passengers and their cabin baggage may be exempted from screening, if: (a) they remain on board the aircraft; or (b) they do not mix with screened departing passengers other than those who board the same aircraft; or (c) they arrive from a Member State, unless the Commission or that Member State has provided information that those passengers and their cabin baggage cannot be considered as having been screened to the common basic standards; or (d) they arrive from a third country where the security standards applied are recognised as equivalent to the common basic standards in accordance with the regulatory procedure referred to in Article 19(2). 4.2. Protection of passengers and cabin baggage 1. Passengers and their cabin baggage shall be protected from unauthorised interference from the point at which they are screened until departure of the aircraft on which they are carried. 2. Screened departing passengers shall not mix with arriving passengers, unless: (a) the passengers arrive from a Member State, provided that the Commission or that Member State has not provided information that those arriving passengers and their cabin baggage cannot be considered as having been screened to the common basic standards; or (b) the passengers arrive from a third country where the security standards applied are recognised as equivalent to the common basic standards in accordance with the regulatory procedure referred to in Article 19(2). 4.3. Potentially disruptive passengers Before departure potentially disruptive passengers shall be subjected to appropriate security measures. 5. HOLD BAGGAGE 5.1. Screening of hold baggage 1. All hold baggage shall be screened prior to being loaded onto an aircraft in order to prevent prohibited articles from being introduced into security restricted areas and on board aircraft. 2. Transfer hold baggage may be exempted from screening, if: (a) it arrives from a Member State, unless the Commission or that Member State has provided information that this hold baggage cannot be considered as having been screened to the common basic standards; or (b) it arrives from a third country where the security standards applied are recognised as equivalent to the common basic standards in accordance with the regulatory procedure referred to in Article 19(2). 3. Transit hold baggage may be exempted from screening if it remains on board the aircraft. 5.2. Protection of hold baggage Hold baggage to be carried on an aircraft shall be protected from unauthorised interference from the point at which it is screened or accepted into the care of the air carrier, whichever is earlier, until the departure of the aircraft on which it is to be carried. 5.3. Baggage reconciliation 1. Each item of hold baggage shall be identified as accompanied or unaccompanied. 2. Unaccompanied hold baggage shall not be transported, unless that baggage has been either separated due to factors beyond the passenger\u2019s control or subjected to appropriate security controls. 6. CARGO AND MAIL 6.1. Security controls for cargo and mail 1. All cargo and mail shall be subjected to security controls prior to being loaded on an aircraft. An air carrier shall not accept cargo or mail for carriage on an aircraft unless it has applied such controls itself or their application has been confirmed and accounted for by a regulated agent, a known consignor or an account consignor. 2. Transfer cargo and transfer mail may be subjected to alternative security controls to be detailed in an implementing act. 3. Transit cargo and transit mail may be exempted from security controls if it remains on board the aircraft. 6.2. Protection of cargo and mail 1. Cargo and mail to be carried on an aircraft shall be protected from unauthorised interference from the point at which security controls are applied until the departure of the aircraft on which it is to be carried. 2. Cargo and mail that are not adequately protected from unauthorised interference after security controls have been applied shall be screened. 7. AIR CARRIER MAIL AND AIR CARRIER MATERIALS Air carrier mail and air carrier materials shall be subjected to security controls and thereafter protected until loaded onto the aircraft in order to prevent prohibited articles from being introduced on board an aircraft. 8. IN-FLIGHT SUPPLIES In-flight supplies, including catering, intended for carriage or use on board an aircraft shall be subjected to security controls and thereafter protected until loaded onto the aircraft in order to prevent prohibited articles from being introduced on board an aircraft. 9. AIRPORT SUPPLIES Supplies intended to be sold or used in security restricted areas of airports, including supplies for duty-free shops and restaurants, shall be subjected to security controls in order to prevent prohibited articles from being introduced into these areas. 10. IN-FLIGHT SECURITY MEASURES 1. Without prejudice to the applicable aviation safety rules: (a) unauthorised persons shall be prevented from entering the flight crew compartment during a flight; (b) potentially disruptive passengers shall be subjected to appropriate security measures during a flight. 2. Appropriate security measures such as training of flight crew and cabin staff shall be taken to prevent acts of unlawful interference during a flight. 3. Weapons, with the exception of those carried in the hold, shall not be carried on board an aircraft, unless the required security conditions in accordance with national laws have been fulfilled and authorisation has been given by the states involved. 4. Paragraph 3 shall also apply to in-flight security officers if they carry weapons. 11. STAFF RECRUITMENT AND TRAINING 1. Persons implementing, or responsible for implementing, screening, access control or other security controls shall be recruited, trained and, where appropriate, certified so as to ensure that they are suitable for employment and competent to undertake the duties to which they are assigned. 2. Persons other than passengers requiring access to security restricted areas shall receive security training, before either an airport identification card or crew identification card is issued. 3. Training as mentioned in paragraphs 1 and 2 shall be conducted on initial and recurrent basis. 4. Instructors engaged in the training of the persons mentioned in paragraphs 1 and 2 shall have the necessary qualifications. 12. SECURITY EQUIPMENT Equipment used for screening, access control and other security controls shall comply with the defined specifications and be capable of performing the security controls concerned.", "summary": "Civil aviation security: EU-wide rules Civil aviation security: EU-wide rules SUMMARY OF: Regulation (EC) No 300/2008 on common rules in the field of civil aviation security WHAT IS THE AIM OF THE REGULATION? It lays down common rules and basic standards on aviation security and on procedures to monitor their implementation. It applies to all civil airports in the EU, as well as to air carriers and other persons or businesses providing goods or services to or through these airports. It replaces Regulation (EC) No 2320/2002 which was adopted in the wake of the 11 September 2001 events and which established common rules in the field of civil aviation security. KEY POINTS Common basic standards for protecting civil aviation These standards include, for example: screening of passengers and cabin baggage to stop prohibited articles, such as weapons and explosives, being carried on board aircraft; the hold luggage (luggage that passengers check in) is also screened before loading; airport security (e.g. controlled access to different areas of airports, staff screening and checking of vehicles, as well as surveillance and patrols to prevent unauthorised people from entering these areas); protection of aircraft and aircraft security checks or searches before departure to ensure that no prohibited articles are on board; security controls for cargo and mail before being loaded on to aircraft; security controls for airport supplies (i.e. supplies intended to be sold in duty-free shops and restaurants) and in-flight supplies (e.g. food and drink for passengers); staff recruitment and training; security equipment performance (i.e. equipment used for screening and access controls complies with defined specifications and is capable of performing the security controls concerned). In November 2015, the European Commission adopted Implementing Regulation (EU) 2015/1998. It lays down detailed measures for the implementation of these security standards and repealed a previous regulation (Regulation (EU) No 185/2010) which had been amended more than 20 times. Since its adoption, Implementing Regulation (EU) 2015/1998 has itself been amended several times. The amendments modify the list of non-EU countries recognised as applying equivalent standards to those of the EU, and introduce new rules regarding: airport security; aircraft security; screening of liquids, aerosols and gels, hold baggage, cargo and mail, in-flight supplies; staff recruitment and training; security equipment; background checks to enhance security culture and resilience; performance standards; the use of shoe explosive detection equipment and explosive vapour detection equipment. Obligations on EU countries and on airports and operators EU countries must: designate a single authority responsible for aviation security; set up a national civil aviation security programme to define responsibilities for implementing the common basic standards; set up a national quality control programme to check the quality of civil aviation security. Airports, air carriers and entities must: define and implement a security programme; ensure internal quality control. Commission inspections The Commission carries out inspections in cooperation with national authorities including unannounced inspections of airports, air carriers and other relevant persons or businesses. Any shortcomings must be remedied by the national authority. National authorities are responsible for primary quality control and enforcement, and therefore must carry out audits and inspections of airports, air carriers and other relevant persons or businesses. Recognition of equivalent aviation security standards with non-EU countries The EU may recognise non-EU countries\u2019 aviation security standards as equivalent to EU standards to allow a \u2018one-stop security\u2019 system. This means, for example, that passengers arriving at EU airports and transferring to other destinations would no longer need to be re-screened. This would result in faster connection times, lower costs and greater convenience for travellers. \u2018One-stop security\u2019 is one of the objectives of EU aviation security legislation. Implementation reports Every year, the Commission publishes a report on the implementation of Regulation (EC) No 300/2008. The latest report, relating to 2017, was published in 2019. COVID-19 pandemic The COVID-19 pandemic severely limits the capability of EU countries and the EU as a whole to maintain an effective and efficient in-bound supply chain. Continued and uninterrupted cargo services are of essential strategic importance for the Union and play a fundamental role in the delivery of essential goods, including medicines, medical equipment, other substances and commodities. Implementing Regulation (EU) 2020/910 therefore amends Regulation (EU) 2015/1998 as regards re-designating airlines, operators and entities providing security controls for cargo and mail arriving from non-EU countries, as well as postponing certain regulatory requirements. The Annex to Regulation (EU) 2015/1998 is amended to take account of factors such as the pandemic\u2019s impact on the performance of on-site installations, checks and visits, and the need to adopt urgent measures establishing the appropriate legal basis to implement an alternative and expedite process for the EU aviation security validations of EU-bound supply chain operators affected. FROM WHEN DOES THE REGULATION APPLY? It has applied since 28 April 2010 The following articles have applied since 29 April 2008: Articles 4(2), 4(3), 4(4), all of which relate to common basic standards except those relating to safeguarding civil aviation against acts of unlawful interference; Article 8 on cooperation with the International Civil Aviation Organisation; Article 11(2): specifications for national quality control programmes; Article 15(1) second subparagraph: unannounced inspections by the Commission; Article 17: Stakeholders\u2019 Advisory Group; Article 19: Committee procedure; and Article 21: penalties. BACKGROUND For more information, see: Aviation Security (European Commission). MAIN DOCUMENT Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, pp. 72-84) Successive amendments to Regulation (EC) No 300/2008 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) 2020/910 of 30 June 2020 amending Implementing Regulations (EU) 2015/1998, (EU) 2019/103 and (EU) 2019/1583 as regards the re-designation of airlines, operators and entities providing security controls for cargo and mail arriving from third countries, as well as the postponement of certain regulatory requirements in the area of cybersecurity, background check, explosive detection systems equipment standards, and explosive trace detection equipment, because of the COVID-19 pandemic (OJ L 208, 1.7.2020, pp. 43-47) Commission Implementing Regulation (EU) 2015/1998 of 5 November 2015 laying down detailed measures for the implementation of the common basic standards on aviation security (OJ L 299, 14.11.2015, pp. 1-142) See consolidated version. Commission Regulation (EU) No 72/2010 of 26 January 2010 laying down procedures for conducting Commission inspections in the field of aviation security (OJ L 23, 27.1.2010, pp. 1-5) See consolidated version. Commission Regulation (EU) No 1254/2009 of 18 December 2009 setting criteria to allow Member States to derogate from the common basic standards on civil aviation security and to adopt alternative security measures (OJ L 338, 19.12.2009, p. 17) See consolidated version. Commission Regulation (EC) No 272/2009 of 2 April 2009 supplementing the common basic standards on civil aviation security laid down in the Annex to Regulation (EC) No 300/2008 of the European Parliament and of the Council (OJ L 91, 3.4.2009, pp. 7-13) See consolidated version. Report from the Commission to the European Parliament and the Council \u2014 2017 annual report on the implementation of Regulation (EC) No 300/2008 on common rules in the field of civil aviation security (COM(2019) 183 final, 16.4.2019) last update 14.09.2020"}
{"article": "7.12.2020 EN Official Journal of the European Union LI 410/1 COUNCIL REGULATION (EU) 2020/1998 of 7 December 2020 concerning restrictive measures against serious human rights violations and abuses THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 215 thereof, Having regard to Council Decision (CFSP) 2020/1999 of 7 December 2020 concerning restrictive measures against serious human rights violations and abuses (1), Having regard to the joint proposal from the High Representative of the Union for Foreign Affairs and Security Policy and the European Commission, Whereas: (1) On 7 December 2020, the Council adopted Decision (CFSP) 2020/1999, which establishes a framework for targeted restrictive measures to address serious human rights violations and abuses worldwide. That Decision provides for the freezing of funds and economic resources of, and the prohibition to make funds and economic resources available to, natural or legal persons, entities or bodies responsible for, providing support to or otherwise involved in serious human rights violations or abuses, as well as those associated with the natural and legal persons, entities and bodies covered. Natural and legal persons, entities and bodies subject to the restrictive measures are listed in the Annex to Decision (CFSP) 2020/1999. That Decision emphasises the importance of international human rights law and of the interaction between international human rights law and international humanitarian law when considering the application of targeted restrictive measures. (2) This Regulation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, in particular the right to an effective remedy, the right to defence, and the right to the protection of personal data. This Regulation should be applied in accordance with those rights. (3) The power to establish and amend the list in Annex I to this Regulation should be exercised by the Council in order to ensure consistency with the process for establishing, amending and reviewing the Annex to Decision (CFSP) 2020/1999. (4) For the implementation of this Regulation, and in order to ensure maximum legal certainty within the Union, the names and other relevant data concerning natural and legal persons, entities and bodies whose funds and economic resources are to be frozen in accordance with this Regulation should be made public. Any processing of personal data should comply with Regulations (EU) 2016/679 (2) and (EU) 2018/1725 (3) of the European Parliament and of the Council. (5) Member States and the Commission should inform each other of the measures taken pursuant to this Regulation and of other relevant information at their disposal in connection with this Regulation. (6) Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and make sure that they are implemented. Those penalties should be effective, proportionate and dissuasive, HAS ADOPTED THIS REGULATION: Article 1 For the purposes of this Regulation, the following definitions apply: (a) \u2018claim\u2019 means any claim, whether asserted by legal proceedings or not, made before or after the date of entry into force of this Regulation, under or in connection with a contract or transaction, and in particular: (i) a claim for performance of any obligation arising under or in connection with a contract or transaction; (ii) a claim for extension or payment of a bond, financial guarantee or indemnity of whatever form; (iii) a claim for compensation in respect of a contract or transaction; (iv) a counterclaim; (v) a claim for the recognition or enforcement, including by the procedure of exequatur, of a judgment, an arbitration award or an equivalent decision, wherever made or given; (b) \u2018contract or transaction\u2019 means any transaction of whatever form and whatever the applicable law, whether comprising one or more contracts or similar obligations made between the same or different parties; for that purpose \u2018contract\u2019 includes a bond, guarantee or indemnity, particularly a financial guarantee or financial indemnity, and credit, whether legally independent or not, as well as any related provision arising under, or in connection with, the transaction; (c) \u2018competent authorities\u2019 refers to the competent authorities of the Member States as identified on the websites listed in Annex II; (d) \u2018economic resources\u2019 means assets of every kind, whether tangible or intangible, movable or immovable, which are not funds, but may be used to obtain funds, goods or services; (e) \u2018freezing of economic resources\u2019 means preventing the use of economic resources to obtain funds, goods or services in any way, including, but not limited to, by selling, hiring or mortgaging them; (f) \u2018freezing of funds\u2019 means preventing any move, transfer, alteration, use of, access to, or dealing with funds in any way that would result in any change in their volume, amount, location, ownership, possession, character, destination or other change that would enable the funds to be used, including portfolio management; (g) \u2018funds\u2019 means financial assets and benefits of every kind, including, but not limited to: (i) cash, cheques, claims on money, drafts, money orders and other payment instruments; (ii) deposits with financial institutions or other entities, balances on accounts, debts and debt obligations; (iii) publicly- and privately-traded securities and debt instruments, including stocks and shares, certificates representing securities, bonds, notes, warrants, debentures and derivatives contracts; (iv) interest, dividends or other income on or value accruing from or generated by assets; (v) credit, right of set-off, guarantees, performance bonds or other financial commitments; (vi) letters of credit, bills of lading, bills of sale; (vii) documents showing evidence of an interest in funds or financial resources; (h) \u2018territory of the Union\u2019 means the territories of the Member States to which the Treaty on European Union (TEU) is applicable, under the conditions laid down in the TEU, including their airspace. Article 2 1. This Regulation applies to: (a) genocide; (b) crimes against humanity; (c) the following serious human rights violations or abuses: (i) torture and other cruel, inhuman or degrading treatment or punishment; (ii) slavery; (iii) extrajudicial, summary or arbitrary executions and killings; (iv) enforced disappearance of persons; (v) arbitrary arrests or detentions; (d) other human rights violations or abuses, including but not limited to the following, in so far as those violations or abuses are widespread, systematic or are otherwise of serious concern as regards the objectives of the common foreign and security policy set out in Article 21 TEU: (i) trafficking in human beings, as well as abuses of human rights by migrant smugglers as referred to in this Article; (ii) sexual and gender-based violence; (iii) violations or abuses of freedom of peaceful assembly and of association; (iv) violations or abuses of freedom of opinion and expression; (v) violations or abuses of freedom of religion or belief. 2. For the purpose of applying paragraph 1, regard should be had to customary international law and widely accepted instruments of international law, such as: (a) the International Covenant on Civil and Political Rights; (b) the International Covenant on Economic, Social and Cultural Rights; (c) the Convention on the Prevention and Punishment of the Crime of Genocide, (d) the Convention against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment; (e) the International Convention on the Elimination of All Forms of Racial Discrimination; (f) the Convention on the Elimination of All Forms of Discrimination against Women; (g) the Convention on the Rights of the Child; (h) the International Convention for the Protection of All Persons from Enforced Disappearance; (i) the Convention on the Rights of Persons with Disabilities; (j) the Protocol to Prevent, Suppress and Punish Trafficking in Persons, Especially Women and Children, supplementing the United Nations Convention against Transnational Organized Crime; (k) the Rome Statute of the International Criminal Court. (l) the European Convention for the Protection of Human Rights and Fundamental Freedoms. 3. For the purposes of applying this Regulation, natural or legal persons, entities or bodies may include: (a) State actors; (b) other actors exercising effective control or authority over a territory; (c) other non-State actors, subject to Article 1(4) of Decision (CFSP) 2020/1999. Article 3 1. All funds and economic resources belonging to, owned, held or controlled by any natural or legal person, entity or body as listed in Annex I shall be frozen. 2. No funds or economic resources shall be made available, directly or indirectly, to or for the benefit of natural or legal persons, entities or bodies listed in Annex I. 3. Annex I shall include, as identified by the Council in accordance with Article 3 of Decision (CFSP) 2020/1999: (a) natural or legal persons, entities or bodies, who are responsible for acts set out in Article 2(1); (b) natural or legal persons, entities or bodies, who provide financial, technical, or material support for or are otherwise involved in acts set out in Article 2(1), including by planning, directing, ordering, assisting, preparing, facilitating, or encouraging such acts; (c) natural or legal persons, entities or bodies, who are associated with the natural or legal persons, entities or bodies covered by points (a) and (b). Article 4 1. By way of derogation from Article 3, the competent authorities of the Member States may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the funds or economic resources concerned are: (a) necessary to satisfy the basic needs of natural or legal persons, entities or bodies listed in Annex I, and dependent family members of such natural persons, including payments for food, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges; (b) intended exclusively for the payment of reasonable professional fees or the reimbursement of incurred expenses associated with the provision of legal services; (c) intended exclusively for the payment of fees or service charges for the routine holding or maintenance of frozen funds or economic resources; (d) necessary for extraordinary expenses, provided that the relevant competent authority has notified the competent authorities of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least two weeks prior to the authorisation; or (e) to be paid into or from an account of a diplomatic or consular mission or an international organisation enjoying immunities in accordance with international law, insofar as such payments are intended to be used for official purposes of the diplomatic or consular mission or international organisation. 2. The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 1 within two weeks of the authorisation. Article 5 1. By way of derogation from Article 3, the competent authorities of the Member States may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary for humanitarian purposes, such as delivering or facilitating the delivery of assistance, including medical supplies, food, or the transfer of humanitarian workers and related assistance or for evacuations. 2. The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 1 within four weeks of the authorisation. Article 6 1. By way of derogation from Article 3(1), the competent authorities of the Member States may authorise the release of certain frozen funds or economic resources, if the following conditions are met: (a) the funds or economic resources are the subject of an arbitral decision rendered prior to the date on which the natural or legal person, entity or body referred to in Article 3 was listed in Annex I, or of a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in the Member State concerned, prior to or after that date; (b) the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims; (c) the decision is not for the benefit of a natural or legal person, entity or body listed in Annex I; and (d) recognition of the decision is not contrary to public policy in the Member State concerned. 2. The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 1 within two weeks of the authorisation. Article 7 1. By way of derogation from Article 3(1) and provided that a payment by a natural or legal person, entity or body listed in Annex I is due under a contract or agreement that was concluded by, or an obligation that arose for, the natural or legal person, entity or body concerned, before the date on which that natural or legal person, entity or body was included in Annex I, the competent authorities of the Member States may authorise, under such conditions as they deem appropriate, the release of certain frozen funds or economic resources, provided that the competent authority concerned has determined that: (a) the funds or economic resources will be used for a payment by a natural or legal person, entity or body listed in Annex I; and (b) the payment is not in breach of Article 3(2). 2. The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 1 within two weeks of the authorisation. Article 8 1. Article 3(2) shall not prevent the crediting of frozen accounts by financial or credit institutions that receive funds transferred by third parties onto the account of a listed natural or legal person, entity or body, provided that any additions to such accounts will also be frozen. The financial or credit institution shall inform the relevant competent authority about any such transaction without delay. 2. Article 3(2) shall not apply to the addition to frozen accounts of: (a) interest or other earnings on those accounts; (b) payments due under contracts, agreements or obligations that were concluded or arose before the date on which the natural or legal person, entity or body referred to in Article 3 was included in Annex I; or (c) payments due under judicial, administrative or arbitral decisions rendered in a Member State or enforceable in the Member State concerned, provided that any such interest, other earnings and payments remain subject to the measures provided for in Article 3(1). Article 9 1. Without prejudice to the applicable rules concerning reporting, confidentiality and professional secrecy, natural and legal persons, entities and bodies shall: (a) supply immediately any information which would facilitate compliance with this Regulation, such as information on accounts and amounts frozen in accordance with Article 3(1), to the competent authority of the Member State where they are resident or located, and transmit such information, directly or through the Member State, to the Commission; and (b) cooperate with the competent authority in any verification of the information referred to in point (a). 2. Any additional information received directly by the Commission shall be made available to the Member States. 3. Any information provided or received in accordance with this Article shall be used only for the purposes for which it was provided or received. Article 10 It shall be prohibited to participate, knowingly and intentionally, in activities the object or effect of which is to circumvent the measures referred to in Article 3. Article 11 1. The freezing of funds and economic resources or the refusal to make funds or economic resources available, carried out in good faith on the basis that such action is in accordance with this Regulation, shall not give rise to liability of any kind on the part of the natural or legal person or entity or body implementing it, or its directors or employees, unless it is proved that the funds and economic resources were frozen or withheld as a result of negligence. 2. Actions by natural or legal persons, entities or bodies shall not give rise to any liability of any kind on their part if they did not know, and had no reasonable cause to suspect, that their actions would infringe the measures set out in this Regulation. Article 12 1. No claims in connection with any contract or transaction the performance of which has been affected, directly or indirectly, in whole or in part, by the measures imposed under this Regulation, including claims for indemnity or any other claim of this type, such as a claim for compensation or a claim under a guarantee, in particular a claim for extension or payment of a bond or of a guarantee or indemnity, in particular a financial guarantee or financial indemnity, of whatever form, shall be satisfied, if they are made by: (a) natural or legal persons, entities or bodies listed in Annex I; (b) any natural or legal person, entity or body acting through or on behalf of one of the natural or legal persons, entities or bodies referred to in point (a). 2. In any proceedings for the enforcement of a claim, the onus of proving that satisfying the claim is not prohibited by paragraph 1 shall be on the natural or legal person, entity or body seeking the enforcement of that claim. 3. This Article is without prejudice to the right of the natural or legal persons, entities and bodies referred to in paragraph 1 to judicial review of the legality of the non-performance of contractual obligations in accordance with this Regulation. Article 13 1. The Commission and Member States shall inform each other of the measures taken under this Regulation and share any other relevant information at their disposal in connection with this Regulation, in particular information in respect of: (a) funds frozen under Article 3 and authorisations granted under Articles 4, 5, 6 and 7; (b) violation and enforcement problems and judgments handed down by national courts. 2. The Member States shall immediately inform each other and the Commission of any other relevant information at their disposal which might affect the effective implementation of this Regulation. Article 14 1. Where the Council decides to subject a natural or legal person, entity or body to the measures referred to in Article 3, it shall amend Annex I accordingly. 2. The Council shall communicate the decision referred to in paragraph 1, including the grounds for listing, to the natural or legal person, entity or body concerned, either directly, if the address is known, or through the publication of a notice, providing that natural or legal person, entity or body with an opportunity to present observations. 3. Where observations are submitted, or where substantial new evidence is presented, the Council shall review the decisions referred to in paragraph 1 and inform the natural or legal person, entity or body concerned accordingly. 4. The list in Annex I shall be reviewed at regular intervals and at least every 12 months. 5. The Commission shall be empowered to amend Annex II on the basis of information supplied by Member States. Article 15 1. Annex I shall include the grounds for the listing of natural or legal persons, entities or bodies concerned. 2. Annex I shall contain, where available, the information necessary to identify the natural or legal persons, entities or bodies concerned. With regard to natural persons, such information may include: names and aliases; date and place of birth; nationality; passport and identity card numbers; gender; address, if known; and function or profession. With regard to legal persons, entities or bodies, such information may include: names; place and date of registration; registration number; and place of business. Article 16 1. Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. 2. Member States shall notify the Commission of the rules referred to in paragraph 1 without delay after the entry into force of this Regulation and shall notify it of any subsequent amendment. Article 17 1. The Council, the Commission and the High Representative of the Union for Foreign Affairs and Security Policy (the \u2018High Representative\u2019) shall process personal data in order to carry out their tasks under this Regulation. These tasks include: (a) as regards the Council, preparing and making amendments to Annex I; (b) as regards the High Representative, preparing amendments to Annex I; (c) as regards the Commission: (i) adding the contents of Annex I to the electronic, consolidated list of persons, groups and entities subject to Union financial sanctions and to the interactive sanctions map, both publicly available; (ii) processing information on the impact of the measures provided for in this Regulation such as the value of frozen funds and information on authorisations granted by the competent authorities. 2. The Council, the Commission and the High Representative may process, where applicable, relevant data relating to criminal offences committed by listed natural persons, to criminal convictions of such persons or to security measures concerning such persons, only to the extent that such processing is necessary for the preparation of Annex I. 3. For the purposes of this Regulation, the Council, the Commission service listed in Annex II to this Regulation and the High Representative are designated as \u2018controller\u2019 within the meaning of point (8) of Article 3 of Regulation (EU) 2018/1725, in order to ensure that the natural persons concerned can exercise their rights under Regulation (EU) 2018/1725. Article 18 1. Member States shall designate the competent authorities referred to in this Regulation and identify them on the websites listed in Annex II. Member States shall notify the Commission of any changes in the addresses of their websites listed in Annex II. 2. Member States shall notify the Commission of their competent authorities, including the contact details of those competent authorities, without delay after the entry into force of this Regulation, and shall notify it of any subsequent amendment. 3. Where this Regulation sets out a requirement to notify, inform or otherwise communicate with the Commission, the address and other contact details to be used for such communication shall be those indicated in Annex II. Article 19 This Regulation shall apply: (a) within the territory of the Union, including its airspace; (b) on board any aircraft or vessel under the jurisdiction of a Member State; (c) to any natural person inside or outside the territory of the Union who is a national of a Member State; (d) to any legal person, entity or body, inside or outside the territory of the Union, which is incorporated or constituted under the law of a Member State; (e) to any legal person, entity or body in respect of any business done in whole or in part within the Union. Article 20 This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 7 December 2020. For the Council The President J. BORRELL FONTELLES (1) See page 13 of this Official Journal. (2) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (3) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). ANNEX I List of natural or legal persons, entities or bodies referred to in Article 3 A. Natural persons B. Legal persons, entities and bodies ANNEX II Websites for information on the competent authorities and address for notifications to the Commission BELGIUM https://diplomatie.belgium.be/nl/Beleid/beleidsthemas/vrede_en_veiligheid/sancties https://diplomatie.belgium.be/fr/politique/themes_politiques/paix_et_securite/sanctions https://diplomatie.belgium.be/en/policy/policy_areas/peace_and_security/sanctions BULGARIA https://www.mfa.bg/en/101 CZECH REPUBLIC www.financnianalytickyurad.cz/mezinarodni-sankce.html DENMARK http://um.dk/da/Udenrigspolitik/folkeretten/sanktioner/ GERMANY http://www.bmwi.de/DE/Themen/Aussenwirtschaft/aussenwirtschaftsrecht,did=404888.html ESTONIA http://www.vm.ee/est/kat_622/ IRELAND http://www.dfa.ie/home/index.aspx?id=28519 GREECE http://www.mfa.gr/en/foreign-policy/global-issues/international-sanctions.html SPAIN http://www.exteriores.gob.es/Portal/en/PoliticaExteriorCooperacion/GlobalizacionOportunidadesRiesgos/Paginas/SancionesInternacionales.aspx FRANCE http://www.diplomatie.gouv.fr/fr/autorites-sanctions/ CROATIA http://www.mvep.hr/sankcije ITALY https://www.esteri.it/mae/it/politica_estera/politica_europea/misure_deroghe CYPRUS http://www.mfa.gov.cy/mfa/mfa2016.nsf/mfa35_en/mfa35_en?OpenDocument LATVIA http://www.mfa.gov.lv/en/security/4539 LITHUANIA http://www.urm.lt/sanctions LUXEMBOURG https://maee.gouvernement.lu/fr/directions-du-ministere/affaires-europeennes/mesures-restrictives.html HUNGARY https://kormany.hu/kulgazdasagi-es-kulugyminiszterium/ensz-eu-szankcios-tajekoztato MALTA https://foreignandeu.gov.mt/en/Government/SMB/Pages/SMB-Home.aspx NETHERLANDS https://www.rijksoverheid.nl/onderwerpen/internationale-sancties AUSTRIA http://www.bmeia.gv.at/view.php3?f_id=12750&LNG=en&version= POLAND https://www.gov.pl/web/dyplomacja PORTUGAL http://www.portugal.gov.pt/pt/ministerios/mne/quero-saber-mais/sobre-o-ministerio/medidas-restritivas/medidas-restritivas.aspx ROMANIA http://www.mae.ro/node/1548 SLOVENIA http://www.mzz.gov.si/si/omejevalni_ukrepi SLOVAKIA https://www.mzv.sk/europske_zalezitosti/europske_politiky-sankcie_eu FINLAND http://formin.finland.fi/kvyhteistyo/pakotteet SWEDEN http://www.ud.se/sanktioner Address for notifications to the European Commission: European Commission Directorate-General for Financial Stability, Financial Services and Capital Markets Union (DG FISMA) Rue de Spa 2 B-1049 Brussels, Belgium Email: relex-sanctions@ec.europa.eu", "summary": "Restrictive measures against serious human rights violations and abuses Restrictive measures against serious human rights violations and abuses SUMMARY OF: Decision (CFSP) 2020/1999 concerning restrictive measures against serious human rights violations and abuses Regulation (EU) 2020/1998 concerning restrictive measures against serious human rights violations and abuses WHAT IS THE AIM OF THE DECISION AND THE REGULATION? They establish a global European Union (EU) sanctions regime for serious human rights violations and abuses. Regulation (EU) 2020/1998 applied automatically and uniformly to all of the EU Member States as soon as it entered into force, without needing to be transposed into national law. It has been amended by Implementing Regulations (EU) 2021/371 of 2 March 2021 and (EU) 2021/478 of 22 March 2021. KEY POINTS The EU global human rights sanctions Regime (EUGHRSR) provides a legal base for the EU to target individuals, companies and bodies \u2014 including those who are and those who are not associated with national governments (state and non-state actors) \u2014 that are responsible for, involved in or associated with serious human rights violations and abuses worldwide, no matter where they occurred. Scope The EUGHRSR covers a number of human rights abuses including: genocide; crimes against humanity; torture and other cruel, inhuman or degrading treatment or punishment; slavery; extrajudicial, summary or arbitrary executions and killings; the enforced disappearance of persons and arbitrary arrests or detentions. The sanctions regime also covers acts which are widespread, systematic or of serious concern in relation to the goals of the common foreign and security policy (CFSP), as set out in Article 21 of the Treaty on European Union. These include: trafficking in human beings; abuses of human rights by migrant smugglers; sexual violence and gender-based violence; violations or abuses of the freedoms: of peaceful assembly and of association,of opinion and expression,of religion or belief. Sanctions and exceptions Restrictive measures will include a travel ban for individuals and the freezing of funds for both individuals and entities. In addition, persons and entities in the EU will be forbidden from making funds available to those who are listed, either directly or indirectly. Member States may grant exceptions from the measures when travel is justified due to: urgent humanitarian need; attendance at intergovernmental meetings or meetings promoted or hosted by the EU; situations where entry or transit is necessary to participate in a judicial process. Amending the list The High Representative of the European Union for Foreign Affairs and Security Policy and the Member States can propose amendments to the list. Amendments are decided upon by the Council of the European Union and are announced publicly. FROM WHEN DO THE DECISION AND REGULATION APPLY? They entered into force on 8 December 2020. BACKGROUND The EUGHRSR was part of the commitments to tackle serious human rights violations and abuses set out in the 2020\u20132024 EU action plan on human rights and democracy. MAIN DOCUMENTS Council Decision (CFSP) 2020/1999 of 7 December 2020 concerning restrictive measures against serious human rights violations and abuses (OJ L 410I, 7.12.2020, pp. 13\u201319). Successive amendments to Decision (CFSP) 2020/1999 have been incorporated into the original text. This consolidated version is of documentary value only. Council Regulation (EU) 2020/1998 of 7 December 2020 concerning restrictive measures against serious human rights violations and abuses (OJ L 410I, 7.12.2020, pp. 1\u201312). See consolidated version. RELATED DOCUMENTS Joint communication to the European Parliament and the Council \u2014 EU Action Plan on Human Rights and Democracy 2020\u20132024 (JOIN(2020) 5 final, 25.3.2020). Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Five \u2014 The Union\u2019s external action \u2014 Title IV \u2014 Restrictive measures \u2014 Article 215 (ex Article 301 TEC) (OJ C 202, 7.6.2016, p. 144). last update 08.12.2021"}
{"article": "1.4.2020 EN Official Journal of the European Union L 101/4 COUNCIL DECISION (CFSP) 2020/472 of 31 March 2020 on a European Union military operation in the Mediterranean (EUNAVFOR MED IRINI) THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on European Union, and in particular Articles 42(4) and 43(2) thereof, Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy, Whereas: (1) On 19 January 2020, a Conference was held in Berlin on Libya. Participants committed in particular to unequivocally and fully respecting and implementing the arms embargo established by the United Nations Security Council Resolution (UNSCR) 1970 (2011) and subsequent Resolutions, in particular UNSCRs 2292 (2016) and 2473 (2019). (2) On 12 February 2020, in UNSCR 2510 (2020), the United Nations (UN) Security Council welcomed the Berlin Conference on Libya and endorsed its conclusions, noting that those conclusions represent an important element of a comprehensive solution to the situation in Libya. It also demanded full compliance by all UN Member States with the arms embargo, and further demanded all States not to intervene in the conflict or take measures that exacerbate the conflict. (3) On 11 February 2020, in UNSCR 2509 (2020), the UN Security Council extended the measures imposed by UNSCR 2146 (2014) to prevent the illicit export from Libya of petroleum, including crude oil and refined petroleum products, and extended the mandate of the Panel of Experts established by UNSCR 1973 (2011). (4) On 17 February 2020, the Council reached a political agreement to launch a new operation in the Mediterranean, aimed at implementing the UN arms embargo on Libya by using aerial, satellite and maritime assets. The operation should, as secondary tasks, contribute to the implementation of UN measures to prevent the illicit export of petroleum from Libya, to capacity building and training of the Libyan Coast Guard and Navy, and to the disruption of the business model of human smuggling and trafficking networks. The Area of Operation and the Area of Interest of the operation should be defined in accordance with the agreed mandate in the relevant planning documents. (5) In addition, the Council could decide in future to extend the scope of the operation in order to allow for the use of aerial surveillance within Libyan airspace, in accordance with any applicable UNSCR or with the consent of the Libyan authorities, if it assesses that the necessary legal requirements and political conditions are met. (6) On 18 May 2015, the Council adopted Decision (CFSP) 2015/778 (1). EUNAVFOR MED operation SOPHIA has been ongoing since that date, and was extended through Council Decision (CFSP) 2019/1595 (2). (7) The Political and Security Committee (PSC) should exercise, under the responsibility of the Council and the High Representative of the Union for Foreign Affairs and Security Policy (HR), political control over the operation, provide it with strategic direction and take the relevant decisions in accordance with the third paragraph of Article 38 of the Treaty on European Union (TEU). (8) The authorisation of the operation should be reconfirmed every four months and the PSC, in exercising its political control and strategic direction of the operation, should be authorised to take such a decision prolonging the operation unless the deployment of maritime assets of the operation produces a pull effect on migration on the basis of substantiated evidence gathered according to the criteria set in the Operations Plan. (9) Pursuant to Article 41(2) TEU and in accordance with Council Decision (CFSP) 2015/528 (3), the operational expenditure arising from this Decision, which has military or defence implications, is to be borne by the Member States. (10) In accordance with Article 5 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the Treaty on the Functioning of the European Union (TFEU), Denmark does not participate in the elaboration and implementation of decisions and actions of the Union which have defence implications. Consequently, Denmark is not participating in the adoption of this Decision, is neither bound by it nor subject to its application, and does not participate in the financing of this operation, HAS ADOPTED THIS DECISION: Article 1 Mission 1. The Union hereby establishes and launches a military crisis management operation to contribute to preventing arms trafficking within its agreed Area of Operation and Area of Interest in accordance with UNSCR 1970 (2011) and subsequent Resolutions on the arms embargo on Libya, including UNSCR 2292 (2016) and UNSCR 2473 (2019). Furthermore, the operation shall contribute to the implementation of UN measures to prevent the illicit export of petroleum from Libya in accordance with UNSCR 2146 (2014) and subsequent Resolutions, in particular UNSCR 2509 (2020) and UNSCR 2510 (2020). In addition, the operation shall assist in the development of the capacities and in the training of the Libyan Coast Guard and Navy in law enforcement tasks at sea. The operation shall also contribute to the disruption of the business model of human smuggling and trafficking networks, in accordance with applicable international law, including the UN Convention on the Law of the Sea, any relevant UNSCR, and international human rights law as applicable. 2. The operation shall be named EUNAVFOR MED IRINI. 3. The Area of Operation, the Area of Interest and the detailed arrangements for gathering information in those areas in order to fulfil all the tasks of the operation shall be defined in the relevant planning documents approved by the Council. Article 2 Contributing to implementation of the UN arms embargo on Libya 1. EUNAVFOR MED IRINI shall, as its core task, contribute to the implementation of the UN arms embargo on Libya with aerial, satellite and maritime assets. 2. For that purpose, EUNAVFOR MED IRINI shall gather extensive and comprehensive information on the trafficking of arms and related materiel from all directions and share it with relevant partners and agencies on a case-by-case and need-to-know basis through the mechanisms in the relevant planning documents in order to contribute to a full situational awareness in the Area of Operation and in the Area of Interest. Where such information is classified up to \u2018SECRET UE/EU SECRET\u2019 level, it may be exchanged with relevant partners and agencies in accordance with Council Decision 2013/488/EU (4) and based on arrangements concluded at the operational level in accordance with Article 14(9) of this Decision, and in full respect of the principles of reciprocity and inclusiveness. Classified information received shall be handled by EUNAVFOR MED IRINI without any distinction between its staff and solely on the basis of operational requirements. 3. In accordance with the relevant UNSCRs, in particular UNSCR 2292 (2016), and as required, EUNAVFOR MED IRINI shall carry out, in accordance with the arrangements set out in the planning documents, and within the agreed Area of Operation on the high seas off the coast of Libya, inspections of vessels bound to or from Libya where there are reasonable grounds to believe that such vessels are carrying arms or related materiel to or from Libya, directly or indirectly, in violation of the arms embargo on Libya. EUNAVFOR MED IRINI shall take relevant action to seize and dispose of such items, including with a view to diverting such vessels and their crews to a suitable port to facilitate such disposal, with the consent of the port State, in accordance with relevant UNSCRs including UNSCR 2292 (2016). 4. EUNAVFOR MED IRINI shall report to the PSC on all issues and events related to such inspections. The PSC may consider any subsequent measures, as appropriate. 5. In view of the exceptional operational requirements, and upon invitation from a Member State, EUNAVFOR MED IRINI may divert vessels to ports of that Member State and dispose within that Member State of arms and related materiel seized in accordance with paragraph 3, including by storage and destruction. The ports to which vessels may be diverted shall be designated in the Operations Plan. 6. In accordance with relevant UNSCRs, including UNSCR 2292 (2016), EUNAVFOR MED IRINI may, in particular in the course of inspections carried out in accordance with paragraph 3, collect and store evidence related to the carriage of items prohibited under the arms embargo on Libya. EUNAVFOR MED IRINI may collect and store, in accordance with applicable law, personal data concerning persons involved in the carriage of such prohibited items related to characteristics likely to assist in their identification, including fingerprints, as well as the following particulars, with the exclusion of other personal data: surname, maiden name, given names and any alias or assumed name; date and place of birth, nationality, sex, place of residence, profession and whereabouts; driving licenses, identification documents and passport data. EUNAVFOR MED IRINI may transmit such data as well as data related to the vessels and equipment used by such persons, and the relevant information acquired while carrying out this core task, to the relevant law enforcement authorities of Member States and to competent Union bodies in accordance with applicable law. Article 3 Contributing to implementation of the UN measures against illicit exports of petroleum from Libya 1. As a secondary task, and within its means and capabilities, EUNAVFOR MED IRINI shall conduct monitoring and surveillance activities and gather information on illicit exports from Libya of petroleum, including crude oil and refined petroleum products, which are contrary to UNSCR 2146 (2014) and subsequent UNSCRs, in particular UNSCR 2509 (2020), thereby contributing to situational awareness in the Area of Operation and in the Area of Interest. 2. The information gathered in this context may be stored and released to the legitimate Libyan authorities and to the relevant law enforcement authorities of Member States and to competent Union bodies. Article 4 Capacity building and training of Libyan Coast Guard and Navy 1. As a further secondary task, EUNAVFOR MED IRINI shall assist in the development of the capacities and in the training of the Libyan Coast Guard and Navy in law enforcement tasks at sea, in particular to prevent human smuggling and trafficking. 2. The task referred to in paragraph 1 shall be carried out on the high seas in EUNAVFOR MED IRINI\u2019s agreed Area of Operation. It may also be carried out in the territory, including the territorial waters, of Libya or of a host third State neighbouring Libya where the PSC so decides following an assessment by the Council on the basis of an invitation by Libya or the host State concerned, and in accordance with international law. 3. In view of the exceptional operational requirements, part of the task referred to in paragraph 1 may be conducted in a Member State, upon invitation by that Member State, including in relevant training centres. 4. For the purpose of the task referred to in paragraph 1, EUNAVFOR MED IRINI shall establish and operate a monitoring mechanism in close coordination with other relevant stakeholders, including where necessary in Libya. 5. Insofar as required by the task referred to in paragraph 1, EUNAVFOR MED IRINI may collect, store and exchange with the relevant authorities of Member States, competent Union bodies, the UN Support Mission in Libya, INTERPOL, the International Criminal Court and the United States of America the information, including personal data, gathered for the purpose of the vetting procedures on possible trainees, provided that they have given their consent in writing. Moreover, EUNAVFOR MED IRINI may collect and store necessary medical information and biometric data on trainees provided that they have given their consent in writing. Article 5 Contributing to disruption of the business model of human smuggling and trafficking networks 1. As another secondary task, and in accordance with UNSCR 2240 (2015), EUNAVFOR MED IRINI shall support the detection and monitoring of human smuggling and trafficking networks through information gathering and patrolling carried out by aerial assets above the high seas, in the agreed Area of Operation. 2. In carrying out this task, EUNAVFOR MED IRINI may collect and store, in accordance with applicable law, data on human smuggling and trafficking, including crimes relevant to the security of the operation, which it may transmit to the relevant law enforcement authorities of Member States and to competent Union bodies. Article 6 Appointment of the EU Operation Commander Rear Admiral Fabio AGOSTINI is hereby appointed EU Operation Commander of EUNAVFOR MED IRINI. Article 7 Designation of the EU Operation Headquarters The Operation Headquarters of EUNAVFOR MED IRINI shall be located in Rome, Italy. Article 8 Political control and strategic direction 1. Under the responsibility of the Council and of the HR, the PSC shall exercise the political control and strategic direction of EUNAVFOR MED IRINI. 2. The Council hereby authorises the PSC to take the relevant decisions in accordance with Article 38 TEU. This authorisation shall include the powers to amend the planning documents, including the Operations Plan, the Chain of Command and the Rules of Engagement. It shall also include the powers to take decisions on the appointment of the EU Operation Commander and the EU Force Commander. The powers of decision with respect to the objectives and termination of the EU military operation shall remain vested in the Council. 3. Notwithstanding the period set out in Article 15(2), the authorisation of the operation shall be reconfirmed every four months. The PSC shall prolong the operation unless the deployment of maritime assets of the operation produces a pull effect on migration on the basis of substantiated evidence gathered according to the criteria set in the Operations Plan. 4. The Operation Commander shall report regularly on the conduct of the operation, including its impact in the Area of Operation. In accordance with Article 38 TEU, the PSC may at any time, upon a request from the HR or a Member State, give direction to the Operation Commander on the deployment of assets. 5. The PSC shall report to the Council at regular intervals. 6. The Chairman of the EU Military Committee (EUMC) shall, at regular intervals, report to the PSC on the conduct of EUNAVFOR MED IRINI. The PSC may invite the EU Operation Commander or the EU Force Commander to its meetings, as appropriate. Article 9 Military direction 1. The EUMC shall monitor the proper execution of EUNAVFOR MED IRINI conducted under the responsibility of the EU Operation Commander. 2. The EU Operation Commander shall, at regular intervals, report to the EUMC. The EUMC may invite the EU Operation Commander or the EU Force Commander to its meetings, as appropriate. 3. The Chairman of the EUMC shall act as the primary point of contact with the EU Operation Commander. Article 10 Consistency of the Union\u2019s response and coordination 1. The HR shall ensure the implementation of this Decision and its consistency with the Union\u2019s external action as a whole, including the Union\u2019s development programmes and its humanitarian assistance. 2. The HR, assisted by the European External Action Service (EEAS), shall act as the primary point of contact with the UN, the authorities of the countries in the region, and other international and bilateral actors, including NATO, the African Union and the League of Arab States. 3. EUNAVFOR MED IRINI shall cooperate with the relevant Member State authorities and shall establish a coordination mechanism, and, as appropriate, conclude arrangements with other Union agencies and bodies, in particular Frontex, EUROPOL, EUROJUST, the European Asylum Support Office, the European Union Satellite Centre (SATCEN) and relevant CSDP missions. 4. EUNAVFOR MED IRINI shall host a Crime Information Cell (CIC) composed of staff of relevant law enforcement authorities of Member States and of Union agencies referred to in paragraph 3, in order to facilitate the receipt, collection and transmission of information, including personal data, on the arms embargo on Libya as referred to in Article 2, on illegal exports from Libya of petroleum as referred to in Article 3, and on human smuggling and trafficking as referred to in Article 5, as well as crimes relevant to the security of the operation. 5. The processing of personal data in this context shall be carried out in accordance with the law of the flag State of the vessel on which the CIC is located and, with respect to staff of Union agencies, in accordance with the legal framework applicable to the respective agencies. 6. EUNAVFOR MED IRINI shall be supported by SATCEN and the European Union Intelligence and Situation Centre (INTCEN) in gathering information as necessary to fulfil its tasks. Article 11 Participation by third States 1. Without prejudice to the Union\u2019s decision-making autonomy or to the single institutional framework, and in accordance with the relevant guidelines of the European Council, third States may be invited to participate in the operation. 2. The Council hereby authorises the PSC to invite third States to offer contributions and to take the relevant decisions on acceptance of the proposed contributions, upon the recommendation of the EU Operations Commander and the EUMC. 3. Detailed arrangements for the participation by third States shall be the subject of agreements concluded pursuant to Article 37 TEU and in accordance with the procedure laid down in Article 218 TFEU. Where the Union and a third State have concluded an agreement establishing a framework for the latter\u2019s participation in crisis management missions of the Union, the provisions of such an agreement shall apply in the context of EUNAVFOR MED IRINI. 4. Third States making significant military contributions to EUNAVFOR MED IRINI shall have the same rights and obligations in terms of day-to-day management of the operation as Member States taking part in the operation. 5. The Council hereby authorises the PSC to take relevant decisions on the setting-up of a Committee of Contributors, should third States provide significant military contributions. Article 12 Status of Union-led personnel The status of Union-led units and personnel shall be defined where necessary in accordance with international law. Article 13 Financial arrangements 1. The common costs of the EU military operation shall be administered in accordance with Decision (CFSP) 2015/528. 2. For the period until 31 March 2021, the reference amount for the common costs of EUNAVFOR MED IRINI shall be EUR 9 837 800. The percentage of the reference amount referred to in Article 25(1) of Decision (CFSP) 2015/528 shall be 30 % in commitments and 30 % for payments. Article 14 Release of Information 1. The HR shall be authorised to release to designated third States and the International Criminal Court, as appropriate and in accordance with the operational needs of EUNAVFOR MED IRINI and in full respect of the principles of reciprocity and inclusiveness, any EU non-classified documents connected with the deliberations of the Council relating to the operation and covered by the obligation of professional secrecy pursuant to Article 6(1) of the Council\u2019s Rules of Procedure (5). The PSC, provided that these conditions are met, shall designate on a case-by-case basis the third States concerned. 2. The HR shall be authorised to release to designated third States and the International Criminal Court, as appropriate and in accordance with the operational needs of EUNAVFOR MED IRINI, and in full respect of the principles of reciprocity and inclusiveness, EU classified information generated for the purposes of the operation, in accordance with Decision 2013/488/EU, as follows: (a) up to the level provided in the applicable Security of Information Agreements concluded between the Union and the third State concerned; or (b) up to the \u2018CONFIDENTIEL UE/EU CONFIDENTIAL\u2019 level in other cases. The PSC, provided that these conditions are met, shall designate on a case-by-case basis the third States concerned. 3. Classified information received shall be handled by EUNAVFOR MED IRINI without any distinction between its staff and solely on the basis of operational requirements. 4. The HR shall also be authorised to release to the UN, in accordance with the operational needs of EUNAVFOR MED IRINI, EU classified information up to \u2018RESTREINT UE/EU RESTRICTED\u2019 level which are generated for the purposes of EUNAVFOR MED IRINI, in accordance with Decision 2013/488/EU. 5. The HR shall be authorised to release to INTERPOL relevant information, including personal data, in accordance with the operational needs of EUNAVFOR MED IRINI. 6. Pending the conclusion of an agreement between the Union and INTERPOL, EUNAVFOR MED IRINI may exchange such information with the National Central Bureaux of INTERPOL of the Member States, in accordance with arrangements to be concluded between the EU Operation Commander and the Head of the relevant National Central Bureau. 7. In the event of specific operational need, the HR shall be authorised, following approval by the PSC, to release to legitimate Libyan authorities any EU classified information up to \u2018RESTREINT UE/EU RESTRICTED\u2019 level generated for the purposes of EUNAVFOR MED IRINI, in accordance with Decision 2013/488/EU. 8. The HR shall be authorised to conclude the arrangements necessary to implement the provisions on information exchange in this Decision. 9. The HR may delegate the authorisations to release information as well as the ability to conclude the arrangements referred to in this Decision to EEAS officials, to the EU Operation Commander or to the EU Force Commander in accordance with section VII of Annex VI to Decision 2013/488/EU. 10. EUNAVFOR MED IRINI shall transmit without delay to the UN, in accordance with UNSCR 2509 (2020), the information gathered on suspected incidents of non-compliance with the UN arms embargo on Libya as provided in UNSCR 1970 (2011) and subsequent Resolutions, in particular UNSCRs 2292 (2016) and 2473 (2019), as well as the information gathered on suspected incidents of non-compliance with the UN measures to prevent illicit exports of petroleum from Libya as provided in UNSCR 2146 (2014) and subsequent Resolutions. Article 15 Entry into force and termination 1. This Decision shall enter into force on the date of its adoption. 2. EUNAVFOR MED IRINI shall end on 31 March 2021. 3. This Decision shall be repealed as from the date of closure of the EU Operation Headquarters in accordance with the plans approved for the termination of EUNAVFOR MED IRINI and without prejudice to the procedures regarding the audit and presentation of the accounts of EUNAVFOR MED IRINI laid down in Decision (CFSP) 2015/528. Done at Brussels, 31 March 2020. For the Council The President A. METELKO-ZGOMBI\u0106 (1) Council Decision (CFSP) 2015/778 of 18 May 2015 on a European Union military operation in the Southern Central Mediterranean (EUNAVFOR MED operation SOPHIA) (OJ L 122, 19.5.2015, p. 31). (2) Council Decision (CFSP) 2019/1595 of 26 September 2019 amending Decision (CFSP) 2015/778 on a European Union military operation in the Southern Central Mediterranean (EUNAVFOR MED operation SOPHIA) (OJ L 248, 27.9.2019, p. 73). (3) Council Decision (CFSP) 2015/528 of 27 March 2015 establishing a mechanism to administer the financing of the common costs of European Union operations having military or defence implications (Athena) and repealing Decision 2011/871/CFSP (OJ L 84, 28.3.2015, p. 39). (4) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). (5) Council Decision 2009/937/EU of 1 December 2009 adopting the Council\u2019s Rules of Procedure (OJ L 325, 11.12.2009, p. 35).", "summary": "A European Union military operation in the Mediterranean (European Union Naval Force Mediterranean operation IRINI) A European Union military operation in the Mediterranean (European Union Naval Force Mediterranean operation IRINI) SUMMARY OF: Decision (CFSP) 2020/472 on a European Union military operation in the Mediterranean WHAT IS THE AIM OF THE DECISION? It sets up European Union Naval Force Mediterranean (EUNAVFOR MED) operation IRINI (Greek for \u2018peace\u2019), whose primary role is to implement the arms embargo on Libya established by United Nations Security Council Resolutions 1970 (2011), 2292 (2016) and 2473 (2019) by using its military aerial, satellite and maritime resources. Operation IRINI\u2019s secondary tasks are to: prevent the illegal export of oil from Libya;train and develop the Libyan coast guard and navy in their law enforcement duties, particularly against human smuggling and trafficking;help clamp down on human smuggling and trafficking by gathering information and patrolling the high seas. KEY POINTS To implement the arms embargo, operation IRINI: monitors and gathers information on illegal exports of arms and related material, petroleum, crude oil and refined petroleum products; inspects vessels to and from Libya suspected of carrying arms; seizes and disposes of any weapons found; collects personal data of people found trafficking; shares information it gathers with the relevant national, EU and international authorities; may divert vessels breaking the arms embargo to a specified port; establishes a crime information cell of national and EU law enforcement authorities to handle and process the information collected. Decision (CFSP) 2021/542 amends Decision (CFSP) 2020/472 and specifies the arrangements for disposing of arms and related military equipment seized when implementing the United Nations (UN) arms embargo on Libya, including the storage, destruction and transfer of seized items to an EU Member State or to a third party. The European Peace Facility, set up under Decision (CFSP) 2021/509 \u2013 see summary \u2013 bears the costs for storage and disposal of arms and related military equipment seized by operation IRINI within its area of operations, including costs related to the necessary port services. The facility also bears the costs for any financial liability resulting from the diversion of a vessel or from subsequent actions related to the transportation, storage and disposal of the seized items, except in cases of gross negligence or wilful misconduct by the Member State assisting in the disposal or by any of its agents. The political control and strategic direction of operation IRINI are provided by the following. The Political and Security Committee, which reconfirms authorisation of the operation every 4 months and reports regularly to EU governments. The EU Military Committee (set up by Decision 2001/79/CFSP), which monitors the operation. The High Representative of the Union for Foreign Affairs and Security Policy, who: ensures IRINI is consistent with the EU\u2019s overall foreign policy, including its development programmes and humanitarian assistance;acts as main contact point with the UN and other international and bilateral actors, including countries in the region;may share EU classified and non-classified information with non-EU countries and bodies, such as the International Criminal Court, the UN and Interpol. Operation IRINI\u2019s initial mandate ran until 31 March 2021. Amending Decision (CFSP) 2021/542 extended the mandate until 31 March 2023. Operation IRINI\u2019s operational headquarters are in Rome under the command of Rear Admiral Stefano Turchetto. FROM WHEN DOES THE DECISION APPLY? It has applied since 31 March 2020. BACKGROUND At the Berlin Conference on Libya of 19 January 2020 participants committed to fully respecting and implementing the arms embargo imposed by various UN Security Council resolutions. EU Member States agreed on 17 February 2020 to launch a new operation in the Mediterranean to implement the UN arms embargo. At the same time, the EU agreed by Decision (CFSP) 2020/471 to end the EUNAVFOR MED operation Sophia on 31 March 2020. This operation had been launched on 22 June 2015 as part of the EU\u2019s overall approach to migration. For further information, see: EU launches operation IRINI to enforce Libya arms embargo \u2013 press release (Council of the European Union). MAIN DOCUMENT Council Decision (CFSP) 2020/472 of 31 March 2020 on a European Union military operation in the Mediterranean (EUNAVFOR MED IRINI) (OJ L 101, 1.4.2020, pp. 4\u201310). Successive amendments to Decision (CFSP) 2020/472 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Council Decision (CFSP) 2021/509 of 22 March 2021 establishing a European Peace Facility, and repealing Decision (CFSP) 2015/528 (OJ L 102, 24.3.2021, pp. 14\u201362). Council Decision (CFSP) 2020/471 of 31 March 2020 repealing Decision (CFSP) 2015/778 on a European Union military operation in the Southern Central Mediterranean (EUNAVFOR MED operation SOPHIA) (OJ L 101, 1.4.2020, p. 3). last update 11.01.2022"}
{"article": "6.4.2020 EN Official Journal of the European Union L 107/1 REGULATION (EU) 2020/493 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 March 2020 on the False and Authentic Documents Online (FADO) system and repealing Council Joint Action 98/700/JHA THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 87(2)(a) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The European Image Archiving System on False and Authentic Documents Online (FADO) was established by Council Joint Action 98/700/JHA (4) within the General Secretariat of the Council. The FADO system was set up to facilitate the exchange of information on authentic documents and on known methods of falsification between Member State authorities. The FADO system provides for the electronic storage, rapid exchange and validation of information on authentic and false documents. Given that the detection of false documents is also important for citizens, organisations and businesses, the General Secretariat of the Council also made authentic documents available in a Public Register of Authentic Travel and Identity Documents Online, known as PRADO. (2) Due to the fact that the management of the FADO system is outdated and should be adapted to the institutional framework established by the Treaty on the Functioning of the European Union (TFEU), Joint Action 98/700/JHA should be repealed and replaced by a new, updated instrument. (3) This Regulation constitutes the necessary new legal basis for governing the FADO system. (4) Document fraud can ultimately undermine the internal security of the Union. The use of the FADO system as an electronic storage system describing possible detection points, both in authentic and false documents, is an important tool in the fight against document fraud, in particular at the external borders. Given that the FADO system contributes to maintaining a high level of security within the Union by supporting police, border guard and other law enforcement authorities of the Member States in the fight against document fraud, the FADO system constitutes an important tool for the application of the Schengen acquis. (5) While false documents and identity fraud are often detected at the external borders, the fight against false documents is an area covered by police cooperation. False documents are pseudo documents, documents that have been forged and documents that have been counterfeited. The use of false documents in the Union has significantly increased in recent years. Document and identity fraud entails the production and use of false documents and the use of authentic documents obtained by fraudulent means. False documents are a multi-purpose criminal tool because they can be used repeatedly to support different criminal activities, including money laundering and terrorism. The techniques used to produce false documents have become increasingly sophisticated and, as a result, it is necessary to have high-quality information on possible detection points, in particular security features and fraud characteristics, and update that information frequently. (6) The FADO system should contain information on all types of authentic travel, identity, residence and civil status documents, driving licences and vehicle licences issued by Member States, on the laissez-passer issued by the Union and on false versions of such documents in their possession. It should be possible for the FADO system to contain information on other related official documents, in particular those used in support of applications for official documents, issued by Member States, and on false versions thereof. It should also be possible for the FADO system to contain information on all types of authentic travel, identity, residence and civil status documents, driving licences and vehicle licences and on other related official documents, in particular those used in support of applications for official documents, issued by third parties, such as third countries, territorial entities, international organisations and other entities subject to international law, and on false versions thereof. (7) Personal data in the FADO system should only be processed to the extent strictly necessary for the purpose of operating the FADO system. As a direct consequence of the purpose for which the FADO system was created, only limited information related to an identified or identifiable person should be stored in the FADO system. The FADO system should contain personal data in the form of facial images or alphanumerical information only insofar as they are related to security features or the method of falsification of a document. It should be possible to store such limited personal data either in the form of different elements appearing in the specimens of authentic documents or in the form of pseudonymised data in authentic or false documents. The European Border and Coast Guard Agency (the \u2018Agency\u2019), governed by Regulation (EU) 2019/1896 of the European Parliament and of the Council (5), should take the necessary steps to pseudonymise all elements of personal data which are not necessary in relation to the purposes for which the data are processed in accordance with the principle of data minimisation. It should not be possible to search for any elements of personal data in the FADO system nor should it be possible to identify any natural person by means of the FADO system without using additional data. The FADO system should not be used to identify a natural person. (8) Any processing of personal data by Member States in the context of this Regulation should be in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (6) or Directive (EU) 2016/680 of the European Parliament and of the Council (7), as applicable. (9) While Member States are able to maintain or develop their own national systems containing information on authentic and false documents, they should be obliged to provide the Agency with information on authentic documents which they issue, including on the security features thereof, and on false versions of such documents in their possession. The Agency should enter that information in the FADO system and guarantee the uniformity and quality of the information. (10) The Union issues laissez-passer to members of the Union institutions, bodies, offices and agencies and servants of the Union to be used for service purposes in accordance with Council Regulation (EU) No 1417/2013 (8). The Union should be obliged to provide the Agency with information on such authentic documents and the security features thereof. (11) Different stakeholders, including the general public, should be provided with different levels of access to the FADO system depending on their needs and the sensitivity of the data concerned. (12) In order to ensure that Member States control document fraud to a high level, the Member State authorities competent in the area of document fraud, such as police, border guard and other law enforcement authorities and other relevant national authorities, should be provided, on a need-to-know basis, with different levels of access to the FADO system depending on their needs. Member States should determine which competent authorities are to be provided with access and the level of access with which they are to be provided. The Commission and the Agency should also determine which of their administrative units are competent to access the FADO system. The FADO system should enable users to have at their disposal information on any new methods of falsification that are detected and on new authentic documents that are in circulation, depending on their access rights. (13) Over the past years, the Agency has developed expertise in the area of document fraud. Synergies should therefore be enhanced by leveraging the Agency\u2019s expertise in order to benefit the Member States in that area. The Agency should take over and operate the FADO system as provided for in Regulation (EU) 2019/1896. That take over should not affect those actors which already have access to the FADO system, namely the Commission, the Agency, the European Union Agency for Law Enforcement Cooperation, established by Regulation (EU) 2016/794 of the European Parliament and of the Council (9), the Member States and the general public. After the Agency takes over the FADO system, it should provide the Member States with support in the detection of false documents. Additionally, and where appropriate, the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice, established by Regulation (EU) 2018/1726 of the European Parliament and of the Council (10), may provide technical support to the Agency in accordance with Regulation (EU) 2019/1896. (14) It should be ensured that, during the transitional period, the FADO system remains fully operational until the transfer has been effectively carried out and the existing information has been transferred to the new system. The ownership of the existing data should then be transferred to the Agency. (15) This Regulation does not affect the competence of Member States in relation to the recognition of passports, travel documents, visas or other identity documents. (16) In order to allow Union institutions, bodies, offices and agencies other than the Commission and the Agency, third parties, such as third countries, territorial entities, international organisations and other entities subject to international law, or private entities, such as airlines and other carriers, to access information in the FADO system, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of establishing measures granting access in a limited manner to the FADO system to those Union institutions, bodies, offices and agencies, third parties and private entities. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (11). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (17) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission with regard to the technical architecture of the FADO system, the establishment of the technical specifications, the procedures for controlling and verifying information and the determination of the date of the effective implementation of the FADO system by the Agency. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and the Council (12). (18) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union (TEU) and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (19) Ireland is taking part in this Regulation, in accordance with Article 5(1) of Protocol No 19 on the Schengen acquis integrated into the framework of the European Union, annexed to the TEU and to the TFEU and Article 6(2) of Council Decision 2002/192/EC (13). (20) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters\u2019 association with the implementation, application and development of the Schengen acquis (14), which fall within the area referred to in Article 1, point H, of Council Decision 1999/437/EC (15). (21) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (16), which fall within the area referred to in Article 1, point H, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/149/JHA (17). (22) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (18), which fall within the area referred to in Article 1, point H, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/349/EU (19). (23) The European Data Protection Supervisor was consulted in accordance with point (d) of Article 46 of Regulation (EC) No 45/2001 of the European Parliament and of the Council (20) and delivered an opinion on 3 December 2018, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and purpose This Regulation establishes the False and Authentic Documents Online (FADO) system containing information on authentic documents issued by Member States, the Union and third parties, such as third countries, territorial entities, international organisations and other entities subject to international law, and on false versions thereof. The purpose of the FADO system is to contribute to the fight against document and identity fraud by sharing information on the security features of, and potential fraud characteristics in, authentic and false documents between the Member State authorities competent in the area of document fraud. The purpose of the FADO system is also to contribute to the fight against document and identity fraud by sharing information with other actors, including the general public. Article 2 Scope and content of the FADO system 1. The FADO system shall contain information on travel, identity, residence and civil status documents, driving licences and vehicle licences issued by Member States or the Union, and on false versions thereof. The FADO system may contain information on documents as referred to in the first subparagraph issued by third parties, such as third countries, territorial entities, international organisations and other entities subject to international law, and on false versions thereof. The FADO system may contain information on other related official documents, in particular those used in support of applications for official documents, issued by Member States and, where applicable, third parties, such as third countries, territorial entities, international organisations and other entities subject to international law, and on false versions thereof. 2. The information referred to in paragraph 1 shall be the following: (a) information, including images, on authentic documents, and specimens thereof, and their security features; (b) information, including images, on false documents, whether forged, counterfeit or pseudo documents, and their fraud characteristics; (c) summaries of forgery techniques; (d) summaries of the security features of authentic documents; and (e) statistics on detected false documents. The FADO system may also contain handbooks, contact lists, information on valid travel documents and their recognition by Member States, recommendations on effective ways of detecting specific methods of falsification and other useful related information. 3. Member States and the Union shall transmit without delay to the European Border and Coast Guard Agency (the \u2018Agency\u2019) the information on the documents referred to in the first subparagraph of paragraph 1. Member States may transmit to the Agency the information on the documents referred to in the second and third subparagraphs of paragraph 1. Third parties, such as third countries, territorial entities, international organisations and other entities subject to international law, may transmit to the Agency the information on the documents referred to in the second and third subparagraphs of paragraph 1. Article 3 Responsibilities of the Agency 1. In the performance of its task in accordance with Article 79 of Regulation (EU) 2019/1896, the Agency shall ensure the proper and reliable functioning of the FADO system and provide support to the competent Member State authorities in the detection of false documents. 2. The Agency shall be responsible for entering in the FADO system in a timely and efficient manner the information obtained and shall guarantee the uniformity and quality of that information. Article 4 Architecture of the FADO system and access thereto 1. The architecture of the FADO system shall provide users with different levels of access to information. 2. The Commission and the Agency, to the extent necessary for the performance of their tasks, and the Member State authorities competent in the area of document fraud, such as police, border guard and other law enforcement authorities and other relevant national authorities, shall have secure access to the FADO system on a need-to-know basis. 3. The architecture of the FADO system shall provide the general public with access to specimens of authentic documents or authentic documents with pseudonymised data. 4. The following actors may obtain access to information stored in the FADO system in a limited manner: (a) Union institutions, bodies, offices and agencies, other than those referred to in paragraph 2; (b) third parties, such as third countries, territorial entities, international organisations and other entities subject to international law; (c) private entities, such as airlines and other carriers. 5. The Commission shall adopt delegated acts in accordance with Article 8 supplementing this Regulation by establishing measures granting access to information stored in the FADO system to the actors listed in paragraph 4 of this Article. The delegated acts shall set out for the actors listed in paragraph 4 of this Article the part of the FADO system to which access is to be granted and any specific procedures and conditions that may be necessary, including the requirement to conclude an agreement between the Agency and a third party or a private entity as referred to in points (b) and (c) of paragraph 4 of this Article. 6. Member States shall determine which authorities competent in the area of document fraud and other relevant national authorities are to have access to the FADO system, including the level of access with which they are to be provided, and notify the Commission and the Agency thereof. Upon request, the Commission shall transmit the information referred to in the first subparagraph to the European Parliament. Article 5 Processing of personal data by the Agency 1. The Agency shall apply Regulation (EU) 2018/1725 of the European Parliament and of the Council (21) when processing personal data under this Regulation. The Agency shall only process personal data where such processing is necessary for the performance of its task of operating the FADO system. As regards authentic documents, the FADO system shall only contain personal data included in the specimens of such documents or pseudonymised data. As regards false documents, the FADO system shall only contain personal data to the extent they are necessary to describe or illustrate the fraud characteristics or the method of falsification of such documents. 2. The Agency shall ensure that technical and organisational measures, such as pseudonymisation, are in place in order to ensure that personal data are only processed to the extent strictly necessary for the purpose of operating the FADO system in line with the principle of data minimisation in a way which does not permit the identification of any natural person through the FADO system without using additional data. Article 6 Implementing acts 1. The Commission shall adopt implementing acts in order to: (a) establish the technical architecture of the FADO system; (b) establish the technical specifications for entering and storing information in the FADO system in accordance with high standards; (c) establish the procedures for controlling and verifying the information contained in the FADO system; (d) determine the date of the effective implementation of the FADO system by the Agency. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 7(2). 2. The Commission shall adopt the implementing act referred to in point (d) of paragraph 1 after verifying that the following conditions have been met: (a) the implementing acts referred to in points (a), (b) and (c) of paragraph 1 have been adopted; (b) the Agency has notified the Commission of the successful implementation of the architecture of the FADO system; (c) the Agency has notified the Commission that the transmission of information from the General Secretariat of the Council to the Agency has been completed. Article 7 Committee procedure 1. The Commission shall be assisted by the committee established by Article 6 of Council Regulation (EC) No 1683/95 (22). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 8 Exercise of delegation 1. The power to adopt delegated acts is conferred on to the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 4(5) shall be conferred on the Commission for an indeterminate period of time from 26 April 2020. 3. The delegation of power referred to in Article 4(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 4(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 9 Repeal and transitional provisions 1. Joint Action 98/700/JHA is repealed with effect from the date of the effective implementation of the FADO system by the Agency, to be determined by means of an implementing act as referred to in point (d) of the first subparagraph of Article 6(1) of this Regulation. 2. The General Secretariat of the Council shall transfer the information contained in the FADO system as established by Joint Action 98/700/JHA to the Agency. 3. Member States shall agree to the transmission by the General Secretariat of the Council of the information in their ownership stored in the FADO system as established by Joint Action 98/700/JHA to the FADO system as established by this Regulation. Article 10 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 30 March 2020. For the European Parliament The President D.M. SASSOLI For the Council The President G. GRLI\u0106 RADMAN (1) OJ C 110, 22.3.2019, p. 62. (2) OJ C 168, 16.5.2019, p. 74. (3) Position of the European Parliament of 13 February 2020 (not yet published in the Official Journal) and decision of the Council of 20 March 2020. (4) Joint Action 98/700/JHA of 3 December 1998 adopted by the Council on the basis of Article K.3 of the Treaty on European Union concerning the setting up of a European Image Archiving System (FADO) (OJ L 333, 9.12.1998, p. 4). (5) Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, p. 1). (6) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (7) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (8) Council Regulation (EU) No 1417/2013 of 17 December 2013 laying down the form of the laissez-passer issued by the European Union (OJ L 353, 28.12.2013, p. 26). (9) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53). (10) Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, p. 99). (11) OJ L 123, 12.5.2016, p. 1. (12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (13) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland\u2019s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (14) OJ L 176, 10.7.1999, p. 36. (15) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (16) OJ L 53, 27.2.2008, p. 52. (17) Council Decision 2008/149/JHA of 28 January 2008 on the conclusion on behalf of the European Union of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 50). (18) OJ L 160, 18.6.2011, p. 3. (19) Council Decision 2011/349/EU of 7 March 2011 on the conclusion on behalf of the European Union of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation\u2019s association with the implementation, application and development of the Schengen acquis, relating in particular to judicial cooperation in criminal matters and police cooperation (OJ L 160, 18.6.2011, p. 1). (20) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (21) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (22) Council Regulation (EC) No 1683/95 of 29 May 1995 laying down a uniform format for visas (OJ L 164, 14.7.1995, p. 1).", "summary": "Combating Document Fraud: the False and Authentic Documents Online System Combating Document Fraud: the False and Authentic Documents Online System SUMMARY OF: Regulation (EU) 2020/493 on the false and authentic documents online (FADO) system WHAT IS THE AIM OF THE REGULATION? It repeals Council Joint Action 98/700/JHA (see summary) which originally established the European image archiving system on false and authentic documents online (FADO). It sets out a new legal basis for the FADO system, updating its management system by adapting it to the new institutional base set out in Article 87(2)(a) of the Treaty on the Functioning of the European Union. KEY POINTS The false and authentic documents online system The FADO system contains information on authentic documents issued by EU countries, the EU and third parties (such as non-EU countries, territorial entities, international organisations and other entities subject to international law) and on false versions of those documents. It aims to contribute to the fight against document and identity fraud by: sharing information on the security features of, and potential fraud characteristics in, authentic and false documents between the EU countries\u2019 authorities competent in the area of document fraud;sharing information with other actors, including the general public. Scope The FADO system contains information on documents issued by EU countries or the EU. Documents include: travel, identity, residence and civil status documents;driving licences and vehicle licences. It may also contain information on: equivalent documents issued by third parties;other related official documents, in particular those used in support of applications for official documents, issued by EU countries and, where applicable, third parties. The information to be included in the system includes: information, including images, on authentic documents, specimens of those documents and their security features;information, including images, on false documents, whether forged, counterfeit or pseudo documents, and their fraud characteristics;summaries of forgery techniques;summaries of the security features of authentic documents;statistics on detected false documents. The system may also contain handbooks, contact lists, information on valid travel documents and their recognition by EU countries, recommendations on effective ways of detecting specific methods of falsification and other useful related information. The EU countries, the EU and third parties must submit this information to the European Border and Coast Guard Agency (Frontex) set up by Regulation (EU) 2019/1896 \u2014 see summary. Technical support for Frontex can be provided by eu-LISA, which was set up by Regulation (EU) 2018/1726 \u2014 see summary. Access The FADO system provides users with different levels of access to information: The European Commission and Frontex, to the extent necessary for the performance of their tasks, and relevant national authorities, such as police, border guard and other law enforcement authorities, have secure access to the FADO system on a need-to-know basis. The general public has access to specimens of authentic documents or authentic documents with pseudonymous data. Other actors can gain access to information stored in the FADO system in a limited manner: other EU institutions, bodies, offices and agencies, including Europol, which was set up by Regulation (EU) 2016/794 \u2014 see summary;third parties, such as non-EU countries, territorial entities, international organisations and other entities subject to international law;private entities, such as airlines and other carriers. Personal data is protected by Regulation (EU) 2016/679 \u2014 see summary: use of data by police and judicial authorities is specifically protected by Directive (EU) 2016/680 \u2014 see summary.Frontex must apply the rules set out in Regulation (EU) 2018/1725 \u2014 see summary. FROM WHEN DOES THE REGULATION APPLY? It has applied since 26 April 2020. BACKGROUND The regulation builds upon the Schengen acquis which, on the basis of protocols attached to the Lisbon Treaty, certain EU countries can opt in or out of. Denmark did not take part in the adoption of the regulation and is therefore not bound by it nor subject to its application. It can however decide to opt in within a period of 6 months after the regulation takes effect. Ireland, a non-member of the Schengen-zone, has chosen to take part. The agreement applies additionally to Iceland, Liechtenstein, Norway and Switzerland. MAIN DOCUMENT Regulation (EU) 2020/493 of the European Parliament and of the Council of 30 March 2020 on the false and authentic documents online (FADO) system and repealing Council Joint Action 98/700/JHA (OJ L 107, 6.4.2020, pp. 1-8) RELATED DOCUMENTS Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, pp. 1-131) Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, pp. 99-137) See consolidated version. Consolidated version of the Treaty on the Functioning of the European Union \u2014 Part Three \u2014 Union policies and internal actions \u2014 Title V \u2014 Area of freedom, security and justice \u2014 Chapter 5 \u2014 Police cooperation \u2014 Article 87 (ex Article 30 TEU) (OJ C 202, 7.6.2016, pp. 83-84) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, pp. 53-114) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) See consolidated version. Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, pp. 89-131) See consolidated version. last update 22.10.2020"}
{"article": "9.7.2018 EN Official Journal of the European Union L 173/25 DIRECTIVE (EU) 2018/958 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 June 2018 on a proportionality test before adoption of new regulation of professions THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 46, Article 53(1) and Article 62 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The freedom to choose an occupation is a fundamental right. The Charter of Fundamental Rights of the European Union (\u2018the Charter\u2019) guarantees the freedom to choose an occupation, as well as the freedom to conduct a business. The free movement of workers, the freedom of establishment and the freedom to provide services are fundamental principles of the internal market enshrined in the Treaty on the Functioning of the European Union (TFEU). National rules organising access to regulated professions should therefore not constitute an unjustified or disproportionate obstacle to the exercise of those fundamental rights. (2) In the absence of specific provisions harmonising the requirements on access to a regulated profession or the pursuit thereof laid down in Union law, it is a Member State competence to decide whether and how to regulate a profession within the limits of the principles of non-discrimination and proportionality. (3) The principle of proportionality is one of the general principles of Union law. It follows from case-law (3) that national measures liable to hinder, or to make less attractive, the exercise of fundamental freedoms guaranteed by the TFEU should fulfil four conditions, namely, they should: be applied in a non-discriminatory manner; be justified by public interest objectives; be suitable for securing the attainment of the objective which they pursue; and not go beyond what is necessary in order to attain that objective. (4) Directive 2005/36/EC of the European Parliament and of the Council (4) includes an obligation for Member States to assess the proportionality of their requirements restricting access to, or the pursuit of, regulated professions, and to communicate the results of that assessment to the Commission, launching the \u2018mutual evaluation process\u2019. That process means that Member States had to carry out a screening of all their legislation on all of the professions that were regulated in their territory. (5) The results of the mutual evaluation process revealed a lack of clarity as regards the criteria to be used by Member States when assessing the proportionality of requirements restricting access to, or the pursuit of, regulated professions, as well as an uneven scrutiny of such requirements at all levels of regulation. To avoid fragmentation of the internal market and to eliminate barriers to the taking-up and pursuit of certain employed or self-employed activities, there should be a common approach at Union level, preventing disproportionate measures from being adopted. (6) In its Communication of 28 October 2015 entitled \u2018Upgrading the Single market: more opportunities for people and businesses\u2019, the Commission identified the need to adopt an analytical proportionality framework for Member States to use when reviewing existing regulations of professions or when proposing new ones. (7) This Directive aims to establish rules for proportionality assessments to be conducted by Member States before the introduction of new, or the amendment of existing, professional regulations, in order to ensure the proper functioning of the internal market, while guaranteeing transparency and a high level of consumer protection. (8) The activities covered by this Directive should concern the regulated professions falling within the scope of Directive 2005/36/EC. This Directive should apply to requirements restricting access to, or the pursuit of, existing regulated professions or new professions that Member States are considering whether to regulate. This Directive should apply in addition to Directive 2005/36/EC and without prejudice to other provisions laid down in a separate Union act concerning access to, or the pursuit of, a given regulated profession. (9) This Directive is without prejudice to the competence of Member States to define the organisation and the content of their systems of education and professional training, and in particular as regards the possibility for them to delegate to professional organisations the power to organise or supervise professional education and training. Provisions which do not restrict access to, or the pursuit of, regulated professions, including editorial amendments, technical adaptations to the content of training courses or the modernisation of training regulations, should not fall within the scope of this Directive. Where professional education or training consists of activities which are remunerated, the freedom of establishment and the freedom to provide services should be guaranteed. (10) Where Member States transpose specific requirements concerning the regulation of a given profession established in a separate Union act which does not leave Member States a choice as to the exact way in which they are to be transposed, the assessment of proportionality, as required by specific provisions of this Directive, should not be applied. (11) Member States should be able to rely on a common regulatory framework based on clearly defined legal concepts concerning the different ways to regulate a profession across the Union. There are several ways to regulate a profession, for instance by reserving access to, or the pursuit of, a particular activity to holders of a professional qualification. Member States may also regulate one of the modes of pursuit of a profession by laying down conditions for the use of professional titles or by imposing qualification requirements only on self-employed, on salaried professionals, or on the managers or legal representatives of undertakings, especially where the activity is pursued by a legal person in the form of a professional company. (12) Before introducing new, or amending existing, legislative, regulatory or administrative provisions restricting access to, or the pursuit of, regulated professions, Member States should assess the proportionality of such provisions. The extent of the assessment should be proportionate to the nature, the content and the impact of the provision being introduced. (13) The burden of proof of justification and proportionality lies with the Member States. The reasons for regulating invoked by a Member State by way of justification should thus be accompanied by an analysis of the appropriateness and proportionality of the measure adopted by that Member State and by specific evidence substantiating its arguments. Although a Member State does not necessarily have to produce a specific study or a specific form of evidence or materials establishing the proportionality of such a measure prior to its adoption, it should carry out an objective analysis, taking into account the specific circumstances of that Member State, that demonstrates that there are genuine risks for the achievement of public interest objectives. (14) Member States should carry out proportionality assessments in an objective and independent manner, including where a profession is regulated indirectly by giving a particular professional body the power to regulate. Those assessments could include an opinion obtained from an independent body, including existing bodies that are part of the national legislative process, entrusted by the Member States concerned with the task of providing such opinion. This is particularly important in cases where the assessment is made by local authorities, regulatory bodies or professional organisations, whose greater proximity to local conditions and specialised knowledge could in certain cases make them better placed to identify the best way of meeting the public interest objectives, but whose policy choices could provide benefits to established operators at the expense of new market entrants. (15) It is appropriate to monitor the proportionality of new or amended provisions restricting access to, or the pursuit of, regulated professions after their adoption. A review of the proportionality of a restrictive national measure in the area of regulated professions should be based not only on the objective of that national measure at the time of its adoption, but also on its effects, assessed after its adoption. The assessment of the proportionality of the national measure should be based on developments found to have occurred in the area of the regulated profession since the measure was adopted. (16) As confirmed by settled case-law, any unjustified restriction resulting from national law restricting the freedom of establishment or the freedom to provide services is prohibited, including any discrimination on grounds of nationality or residence. (17) Where the taking-up and the pursuit of employed or self-employed activities are conditional on complying with certain requirements relating to specific professional qualifications, laid down directly or indirectly by the Member States, it is necessary to ensure that such requirements are justified by public interest objectives, such as those within the meaning of the TFEU, namely public policy, public security and public health, or by overriding reasons in the public interest, recognised as such in the case-law of the Court of Justice. It is also necessary to clarify that the following are among the overriding reasons in the public interest, recognised by the Court of Justice: preserving the financial equilibrium of the social security system; the protection of consumers, of recipients of services, including by guaranteeing the quality of craft work, and of workers; the safeguarding of the proper administration of justice; ensuring the fairness of trade transactions; the combating of fraud and the prevention of tax evasion and avoidance, and the safeguarding of the effectiveness of fiscal supervision; transport safety; the protection of the environment and the urban environment; the health of animals; intellectual property; the safeguarding and conservation of the national historic and artistic heritage; social policy objectives; and cultural policy objectives. According to settled case-law, purely economic reasons, namely promoting the national economy to the detriment of the fundamental freedoms, as well as purely administrative reasons, such as carrying out controls or gathering statistics, cannot constitute an overriding reason in the public interest. (18) It is for the Member States to determine the level of protection which they wish to afford to the public interest objectives and the appropriate level of regulation, within the limits of proportionality. The fact that one Member State imposes less strict rules than another Member State does not mean that the latter Member State\u2019s rules are disproportionate and therefore incompatible with Union law. (19) With regard to the protection of public health, according to Article 168(1) TFEU, a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. This Directive is fully in line with that objective. (20) In order to ensure that the provisions they introduce, and that amendments they make to existing provisions, are proportionate, Member States should consider the criteria for assessing the proportionality and the additional criteria which are relevant for the regulated profession being analysed. Where a Member State intends to regulate a profession or to amend existing rules, account should be taken of the nature of the risks related to the public interest objectives pursued, in particular the risks to service recipients, including consumers, to professionals or to third parties. It should also be borne in mind that, in the field of professional services, there is usually an asymmetry of information between consumers and professionals, given that professionals display a high level of technical knowledge which consumers may not have. (21) Requirements linked to professional qualifications should be considered to be necessary only where existing measures, such as product safety law or consumer protection law, cannot be regarded as being suitable or genuinely effective to achieve the aim pursued. (22) To meet the requirement of proportionality, a measure should be suitable for securing the attainment of the objective pursued. A measure should be considered to be suitable for securing the attainment of the objective pursued only if it genuinely reflects a concern to attain that objective in a consistent and systematic manner, for instance where similar risks related to certain activities are addressed in a comparable way and where any exceptions to the restrictions involved are applied in line with the stated objective. Furthermore, the national measure should effectively contribute to achieving the objective pursued and therefore, where it has no effect on the ground for justification, it should not be considered to be suitable. (23) The overall impact of the measure on the free movement of persons and services within the Union, on consumer choice and on the quality of the service provided should be duly taken into account by the Member States. On that basis, Member States should ascertain, in particular, whether the extent of the restriction to access to, or the pursuit of, regulated professions is proportionate to the importance of the objectives pursued and the expected gains. (24) Member States should carry out a comparison between the national measure at issue and alternative, less restrictive means that would result in the same objective being attained but would impose fewer restrictions. Where the measures are justified by consumer protection only and where the risks identified are limited to the relationship between the professional and the consumer and therefore do not negatively affect third parties, Member States should assess whether their objective could be attained by means that are less restrictive than reserving activities to professionals. For instance, where consumers can reasonably make a choice between using the services of qualified professionals or not, less restrictive means, such as protection of the professional title or enrolment on a professional register, should be used. Regulation by way of reserved activities and protected professional title should be considered where the measures aim to prevent a risk of serious harm to public interest objectives, such as public health. (25) Where relevant in view of the nature and the content of the measure being analysed, Member States should also take the following elements into account: the connection between the scope of professional activities covered by a profession and the professional qualification required; the complexity of the tasks in particular as regards the level, the nature and the duration of the training or experience required; the existence of different routes to obtain the professional qualification; whether the activities reserved to certain professionals can be shared with other professionals; and the degree of autonomy in exercising a regulated profession in particular where the activities relating to a regulated profession are pursued under the control and responsibility of a duly qualified professional. (26) This Directive takes account of scientific and technological progress, and contributes to the proper functioning of the internal market, including in the digital environment. In view of the speed of technological change and scientific developments, updates in access requirements could be of particular importance for a number of professions, especially for professional services provided by electronic means. Where a Member State regulates a profession, account should be taken of the fact that scientific and technological developments could reduce or increase the asymmetry of information between professionals and consumers. Where the scientific and technological developments carry a high risk to the public interest objectives, it is for the Member States, where necessary, to encourage professionals to keep up with those developments. (27) Member States should carry out a comprehensive assessment of the circumstances in which the measure is adopted and implemented and examine in particular the effect of the new or amended provisions when combined with other requirements restricting access to, or the pursuit of, the profession. The taking-up and pursuit of certain activities may be conditional on complying with several requirements such as rules relating to the organisation of the profession, compulsory membership of a professional organisation or body, professional ethics, supervision and liability. Therefore, when assessing the effect of the new or amended provisions, Member States should take into account the existing requirements, including continuous professional development, compulsory membership of a professional organisation or body, registration or authorisation schemes, quantitative restrictions, specific legal form requirements and shareholding requirements, territorial restrictions, multidisciplinary restrictions and incompatibility rules, requirements concerning insurance cover, language knowledge requirements, to the extent necessary to practise the profession, fixed minimum and/or maximum tariff requirements, and requirements on advertising. (28) The introduction of additional requirements may be suitable to attain the public interest objectives. The mere fact that their individual or combined effect should be assessed does not mean that those requirements are prima facie disproportionate. For example, the obligation to undergo continuous professional development may be suitable to ensure that professionals keep abreast of developments in their respective areas, as long as it does not lay down discriminatory and disproportionate conditions to the detriment of new entrants. Likewise, compulsory membership of a professional organisation or body may be considered appropriate where those professional organisations or bodies are entrusted by the State with safeguarding the relevant public interest objectives, for example in supervising the legitimate practice of the profession, or organising or supervising continuous professional training. Where the independence of a profession cannot be adequately guaranteed by other means, Member States could consider the application of safeguards, such as limiting the shareholding of persons outside the profession or providing that the majority of the voting rights are to be held by persons practising the profession, as long as such safeguards do not go beyond what is necessary in order to protect the public interest objective. Member States could consider establishing fixed minimum and/or maximum tariff requirements with which the service providers must comply, especially for services where this is necessary for the effective application of the principle of reimbursing costs, as long as such restriction is proportionate and, where necessary, derogations from the minimum and/or maximum tariffs are provided for. Where the introduction of additional requirements duplicates requirements which have already been introduced by a Member State in the context of other rules or procedures, such requirements cannot be regarded as proportionate to achieve the objective pursued. (29) Under Title II of Directive 2005/36/EC, Member States cannot impose on service providers established in another Member State providing professional services on a temporary and occasional basis requirements or restrictions prohibited in that Directive, such as authorisation by, registration with, or membership of, a professional organisation or body or having representatives on the territory of the host Member State for the purposes of having access to, or the pursuit of, a regulated profession. Member States can, where necessary, require service providers wishing to provide services on a temporary basis, to provide information in the form of a written declaration to be made in advance of the first service provision and to renew this declaration on a yearly basis. Therefore, in order to facilitate the provision of professional services, it is necessary to reiterate, taking into account the temporary or occasional nature of the service, that requirements, such as automatic temporary registration or pro forma membership of a professional organisation or body, prior declarations and document requirements, as well as the payment of a fee or any charges, should be proportionate. These requirements should not lead to a disproportionate burden on service providers nor should they hinder or render less attractive the exercise of the freedom to provide services. Member States should, in particular, assess whether the requirement to provide certain information and documents in accordance with Directive 2005/36/EC and the possibility of obtaining further details by way of administrative cooperation between Member States through the Internal Market Information System are proportionate and are sufficient to prevent a serious risk of circumvention of the applicable rules by service providers. This Directive should however not apply to measures designed to ensure compliance with applicable employment terms and conditions. (30) As confirmed by settled case-law, the health and life of humans ranks foremost among the interests protected by the TFEU. Consequently, Member States should duly take account of the objective of ensuring a high level of human health protection when assessing requirements for healthcare professions, such as reserved activities, protected professional title, continuous professional development or rules relating to the organisation of the profession, professional ethics and supervision, while respecting the minimum training conditions, laid down in Directive 2005/36/EC. Member States should in particular ensure that the regulation of healthcare professions, having public health and patient safety implications, is proportionate and contributes to the guaranteeing of access to healthcare, recognised as a fundamental right in the Charter, as well as to safe, high quality and efficient healthcare for citizens on their territory. In establishing policies for healthcare services, account should be taken of the need to ensure accessibility, a high quality of service, and an adequate and safe supply of medicinal products, in accordance with the public health needs in the territory of the Member State concerned, as well as of the need to ensure the professional independence of healthcare professionals. With regard to the justification for the regulation of healthcare professions, Member States should take into account the objective of ensuring a high level of human health protection, including accessibility and high quality of healthcare for citizens, and adequate and safe supply of medicinal products, taking into consideration the margin of discretion referred to in Article 1 of this Directive. (31) It is essential for the proper functioning of the internal market to ensure that Member States provide information to citizens, representative associations and other relevant stakeholders, including social partners, before introducing new, or amending existing, requirements restricting access to, or the pursuit of, regulated professions. Member States should involve all parties concerned and give them the opportunity to make their views known. Where relevant and appropriate, Member States should carry out public consultations in accordance with their national procedures. (32) Member States should also give full consideration to citizens\u2019 rights of access to justice, as guaranteed by Article 47 of the Charter and Article 19(1) of the Treaty on European Union (TEU). It follows that, in accordance with procedures laid down in national law and constitutional principles, national courts should be able to assess the proportionality of requirements falling within the scope of this Directive, in order to ensure, for each natural or legal person, the right to an effective remedy against restrictions on the freedom to choose an occupation, on the freedom of establishment and on the freedom to provide services. (33) For the purposes of exchanging information on best practices, Member States should take the necessary measures to encourage the sharing of adequate and regularly updated information with other Member States on the regulation of professions, as well as on the effects of such regulation. The Commission should facilitate that exchange. (34) In order to increase transparency and to promote proportionality assessments based on comparable criteria, the information submitted by Member States, without prejudice to Article 346 TFEU, should be easily accessible in the database of regulated professions, in order to allow other Member States and interested parties to submit comments to the Commission and the Member State concerned. Those comments should be duly taken into account by the Commission in its summary report, produced in accordance with Directive 2005/36/EC. (35) Since the objectives of this Directive, namely to ensure the proper functioning of the internal market and to avoid disproportionate restrictions on access to, or the pursuit of, regulated professions, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS DIRECTIVE: Article 1 Subject matter This Directive lays down rules on a common framework for conducting proportionality assessments before introducing new, or amending existing, legislative, regulatory or administrative provisions restricting access to, or the pursuit of, regulated professions, with a view to ensuring the proper functioning of the internal market, while guaranteeing a high level of consumer protection. It does not affect the Member States\u2019 competence, in the absence of harmonisation, and margin of discretion to decide whether and how to regulate a profession within the limits of the principles of non-discrimination and proportionality. Article 2 Scope 1. This Directive shall apply to the legislative, regulatory or administrative provisions of the Member States restricting access to a regulated profession or its pursuit, or one of its modes of pursuit, including the use of professional titles and the professional activities allowed under such title, falling within the scope of Directive 2005/36/EC. 2. Where specific requirements concerning the regulation of a given profession are established in a separate Union act which does not leave Member States a choice as to the exact way in which they are to be transposed, the corresponding provisions of this Directive shall not apply. Article 3 Definitions For the purpose of this Directive, the definitions of Directive 2005/36/EC apply. In addition, the following definitions apply: (a) \u2018protected professional title\u2019 means a form of regulating a profession where the use of the title in a professional activity or group of professional activities is subject, directly or indirectly, by virtue of legislative, regulatory or administrative provisions to the possession of a specific professional qualification, and where the improper use of that title is subject to sanctions; (b) \u2018reserved activities\u2019 means a form of regulating a profession where the access to a professional activity or group of professional activities is reserved, directly or indirectly, by virtue of legislative, regulatory or administrative provisions to members of a regulated profession holding a specific professional qualification, including where the activity is shared with other regulated professions. Article 4 Ex ante assessment of new measures and monitoring 1. Member States shall undertake an assessment of proportionality in accordance with the rules laid down in this Directive before introducing new, or amending existing, legislative, regulatory or administrative provisions restricting access to, or the pursuit of, regulated professions. 2. The extent of the assessment referred to in paragraph 1 shall be proportionate to the nature, the content and the impact of the provision. 3. Any provision referred to in paragraph 1 shall be accompanied by an explanation which is sufficiently detailed to make it possible to appraise compliance with the principle of proportionality. 4. The reasons for considering that a provision referred to in paragraph 1 is justified and proportionate shall be substantiated by qualitative and, wherever possible and relevant, quantitative elements. 5. Member States shall ensure that the assessment referred to in paragraph 1 is carried out in an objective and independent manner. 6. Member States shall monitor the compliance of new or amended legislative, regulatory or administrative provisions restricting access to, or the pursuit of, regulated professions, after adoption, with the principle of proportionality, having due regard to any developments that have occurred since the provisions concerned were adopted. Article 5 Non-discrimination When introducing new, or amending existing, legislative, regulatory or administrative provisions restricting access to, or the pursuit of, regulated professions, Member States shall ensure that those provisions are neither directly nor indirectly discriminatory on the basis of nationality or residence. Article 6 Justification on grounds of public interest objectives 1. Member States shall ensure that the legislative, regulatory or administrative provisions restricting access to, or the pursuit of, regulated professions that they intend to introduce and that the amendments that they intend to make to existing provisions are justified by public interest objectives. 2. Member States shall consider in particular whether the provisions referred to in paragraph 1 are objectively justified on the basis of public policy, public security or public health, or by overriding reasons in the public interest, such as preserving the financial equilibrium of the social security system; the protection of consumers, of recipients of services and of workers; the safeguarding of the proper administration of justice; ensuring the fairness of trade transactions; the combating of fraud and the prevention of tax evasion and avoidance, and the safeguarding of the effectiveness of fiscal supervision; transport safety; the protection of the environment and the urban environment; the health of animals; intellectual property; the safeguarding and conservation of the national historic and artistic heritage; social policy objectives; and cultural policy objectives. 3. Grounds of a purely economic nature or purely administrative reasons shall not constitute overriding reasons in the public interest, justifying a restriction on access to, or the pursuit of, regulated professions. Article 7 Proportionality 1. Member States shall ensure that the legislative, regulatory or administrative provisions restricting access to, or the pursuit of, regulated professions that they introduce, and that the amendments that they make to existing provisions, are suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective. 2. To that end, before adopting the provisions referred to in paragraph 1, Member States shall consider: (a) the nature of the risks related to the public interest objectives pursued, in particular the risks to service recipients, including consumers, to professionals or to third parties; (b) whether existing rules of a specific or more general nature, such as those contained in product safety law or consumer protection law, are insufficient for the attainment of the objective pursued; (c) the suitability of the provision as regards its appropriateness to attain the objective pursued and whether it genuinely reflects that objective in a consistent and systematic manner and thus addresses the risks identified in a similar way as in comparable activities; (d) the impact on the free movement of persons and services within the Union, on consumer choice and on the quality of the service provided; (e) the possibility of using less restrictive means to achieve the public interest objective; for the purposes of this point, where the provisions are justified by consumer protection only and where the risks identified are limited to the relationship between the professional and the consumer, and therefore do not negatively affect third parties, Member States shall assess in particular whether the objective can be attained by means that are less restrictive than reserving activities; (f) the effect of new or amended provisions, when combined with other provisions restricting access to, or the pursuit of, the profession, and in particular how the new or amended provisions, combined with other requirements contribute to and whether they are necessary for the achievement of the same public interest objective. Member States shall also consider the following elements where relevant to the nature and the content of the provision being introduced or amended: (a) the connection between the scope of activities covered by a profession or reserved to it and the professional qualification required; (b) the connection between the complexity of the tasks concerned and the need for those carrying them out to possess specific professional qualifications, in particular as regards the level, the nature and the duration of the training or experience required; (c) the possibility of obtaining the professional qualification by alternative routes; (d) whether, and why, the activities reserved to certain professions can or cannot be shared with other professions; (e) the degree of autonomy in exercising a regulated profession and the impact of organisational and supervision arrangements on the attainment of the objective pursued, in particular where the activities relating to a regulated profession are pursued under the control and responsibility of a duly qualified professional; (f) the scientific and technological developments which may effectively reduce or increase the asymmetry of information between professionals and consumers. 3. For the purposes of point (f) of the first subparagraph of paragraph 2, Member States shall assess the effect of the new or amended provision when combined with one or more requirements, bearing in mind the fact that such effects might be positive as well as negative, and in particular the following: (a) reserved activities, protected professional title or any other form of regulation within the meaning of point (a) of Article 3(1) of Directive 2005/36/EC; (b) obligations to undergo continuous professional development; (c) rules relating to the organisation of the profession, professional ethics and supervision; (d) compulsory membership of a professional organisation or body, registration or authorisation schemes, in particular where those requirements imply the possession of a specific professional qualification; (e) quantitative restrictions, in particular requirements limiting the number of authorisations to practise, or fixing a minimum or a maximum number of employees, managers or representatives holding specific professional qualifications; (f) specific legal form requirements or requirements which relate to the shareholding or management of a company, to the extent those requirements are directly linked to the exercise of the regulated profession; (g) territorial restrictions, including where the profession is regulated in parts of a Member State\u2019s territory in a manner that is different to the way in which it is regulated in other parts; (h) requirements restricting the exercise of a regulated profession jointly or in partnership, as well as incompatibility rules; (i) requirements concerning insurance cover or other means of personal or collective protection with regard to professional liability; (j) language knowledge requirements, to the extent necessary to practise the profession; (k) fixed minimum and/or maximum tariff requirements; (l) requirements on advertising. 4. Before introducing new, or amending existing, provisions, Member States shall, in addition, ensure the compliance with the principle of the proportionality of specific requirements related to temporary or occasional provision of services, provided under Title II of Directive 2005/36/EC, including: (a) automatic temporary registration with or pro forma membership of a professional organisation or body, referred to in point (a) of the first paragraph of Article 6 of Directive 2005/36/EC; (b) a declaration to be made in advance pursuant to Article 7(1) of Directive 2005/36/EC, documents required pursuant to paragraph 2 of that Article or any other equivalent requirement; (c) the payment of a fee, or any charges, required for the administrative procedures, related to the access to, or the pursuit of, regulated professions which the service provider incurs. This paragraph shall not apply to measures designed to ensure compliance with applicable employment terms and conditions that Member States apply in accordance with Union law. 5. Where provisions referred to in this Article concern the regulation of healthcare professions and have patient safety implications, Member States shall take account of the objective of ensuring a high level of human health protection. Article 8 Information and involvement of stakeholders 1. Member States shall, by appropriate means, make information available to citizens, service recipients and other relevant stakeholders, including those who are not members of the profession concerned, before introducing new, or amending existing, legislative, regulatory or administrative provisions restricting access to, or the pursuit of, regulated professions. 2. Member States shall appropriately involve all parties concerned and shall give them the opportunity to make their views known. Where relevant and appropriate, Member States shall carry out public consultations in accordance with their national procedures. Article 9 Effective remedy Member States shall ensure that an effective remedy is available with regard to the matters covered by this Directive, in accordance with procedures laid down in national law. Article 10 Exchange of information between Member States 1. For the purposes of the efficient application of this Directive, Member States shall take the necessary measures to encourage the exchange of information among Member States on matters covered by this Directive and on the particular way that they regulate a profession, or on the effects of such regulation. The Commission shall facilitate such exchange of information. 2. Member States shall inform the Commission of the public authorities responsible for transmitting and receiving information for the purposes of applying paragraph 1. Article 11 Transparency 1. The reasons for considering that provisions, assessed in accordance with this Directive, are justified and proportionate, which, together with the provisions, are to be communicated to the Commission pursuant to Article 59(5) of Directive 2005/36/EC, shall be recorded by the Member States in the database of regulated professions, referred to in Article 59(1) of Directive 2005/36/EC and shall be made publicly available by the Commission. 2. Member States and other interested parties may submit comments to the Commission or to the Member State which has communicated the provisions and the reasons for considering that they are justified and proportionate. These comments shall be duly taken into account by the Commission in its summary report produced pursuant to Article 59(8) of Directive 2005/36/EC. Article 12 Review 1. By 18 January 2024 and every five years thereafter, the Commission shall submit a report to the European Parliament and to the Council on the implementation and performance of this Directive, including, among other aspects, its scope and its effectiveness. 2. Where appropriate, the report referred to in paragraph 1 shall be accompanied by relevant proposals. Article 13 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 July 2020. They shall immediately inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive. Article 14 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 15 Addressees This Directive is addressed to the Member States. Done at Brussels, 28 June 2018. For the European Parliament The President A. TAJANI For the Council The President L. PAVLOVA (1) OJ C 288, 31.8.2017, p. 43. (2) Position of the European Parliament of 14 June 2018 (not yet published in the Official Journal) and decision of the Council of 21 June 2018. (3) Judgement of the Court of Justice of 30 November 1995, Gebhard, C-55/94, ECLI:EU:C:1995:411, paragraph 37. (4) Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).", "summary": "Proportionality test for new regulation of professions Proportionality test for new regulation of professions SUMMARY OF: Directive (EU) 2018/958 \u2014 proportionality test before adoption of new regulation of professions WHAT IS THE AIM OF THE DIRECTIVE? It establishes rules for proportionality assessments to be conducted by EU countries before adopting new professional regulations or amending existing regulations. It aims to: prevent undue restrictions on access to or the pursuit of professional activities; ensure: transparency;the proper functioning of the internal market. KEY POINTS Regulated professions The directive applies to new rules in EU countries which restrict access to or the pursuit of regulated professions. A regulated profession means that the access to or the pursuit of a professional activity or group of professional activities is restricted, by regulation, to people having specific professional qualifications. This also covers the use of professional titles which are restricted to holders of specific qualifications. Public interest EU countries must ensure that any new or amending rules are justified and proportionate with regard to public interest objectives recognised by the Court of Justice of the European Union, such as: public policy, public security or public health; protecting consumers, the recipients of services, and workers; safeguarding the effectiveness of fiscal supervision; combating fraud and preventing tax evasion and avoidance; protection of the environment. Assessment of new measures beforehand and monitoring afterwards EU countries must: assess the proportionality of a measure before introducing new, or amending existing, legislative, regulatory or administrative rules; and monitor the compliance of such measures with the principle of proportionality after their adoption. Assessment The assessment must be: accompanied by a sufficiently detailed explanation which allows for an assessment of whether it complies with the principle of proportionality; undertaken on the basis of qualitative, and where possible, quantitative evidence; carried out in an open and objective manner. Proportionality In assessing the proportionality of new or amending rules, EU countries must consider a number of proportionality criteria established by the Court of Justice, including: whether the measure can achieve the public interest objective, and whether that objective is being pursued in a consistent and systematic manner for comparable activities; whether existing rules, such as product safety law or consumer protection law, are not able to achieve the objective; the impact on the free movement of persons and services within the EU, on consumer choice and on the quality of the service provided; whether less restrictive means could achieve the public interest objective; the effect of new rules when combined with other requirements. Transparency Before introducing new regulations, EU countries must: make information available to the relevant people concerned; and must give them the opportunity to make their views known. The reasons for proportionality need to be recorded in the Regulated Professions Database and made publicly available. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 29 July 2018 and has to become law in the EU countries from 30 July 2020. BACKGROUND This directive is a part of the \u2018Services package\u2019 which aims to make it easier for companies and professionals to provide services to EU consumers. The package, published on 10 January 2017, contains two additional legislative proposals: Proposal for a services e-card (European Commission) Proposal for a services notification procedure (European Commission). MAIN DOCUMENT Directive (EU) 2018/958 of the European Parliament and of the Council of 28 June 2018 on a proportionality test before adoption of new regulation of professions (OJ L 173, 9.7.2018, pp. 25-34) RELATED DOCUMENT Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, pp. 22-142) Successive amendments to Directive 2005/36/EC have been incorporated into the original document. This consolidated version is of documentary value only. last update 10.10.2018"}
{"article": "16.7.2018 EN Official Journal of the European Union L 179/1 REGULATION (EU) 2018/973 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2018 establishing a multiannual plan for demersal stocks in the North Sea and the fisheries exploiting those stocks, specifying details of the implementation of the landing obligation in the North Sea and repealing Council Regulations (EC) No 676/2007 and (EC) No 1342/2008 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The United Nations Convention of 10 December 1982 on the Law of the Sea, to which the Union is a contracting party, provides for conservation obligations, including maintaining or restoring populations of harvested species at levels which can produce the maximum sustainable yield (\u2018MSY\u2019). (2) At the United Nations Summit on Sustainable Development held in New York in 2015, the Union and its Member States committed themselves, by 2020, to effectively regulate harvesting, to end overfishing, illegal, unreported and unregulated fishing and destructive fishing practices, and to implement science-based management plans, in order to restore fish stocks, in the shortest time feasible, at least to levels that can produce MSY as determined by their biological characteristics. (3) Regulation (EU) No 1380/2013 of the European Parliament and of the Council (3) establishes the rules of the Common Fisheries Policy (\u2018CFP\u2019) in line with the international obligations of the Union. The CFP is to contribute to the protection of the marine environment, the sustainable management of all commercially exploited species and in particular the achievement of good environmental status by 2020, as set out in Article 1(1) of Directive 2008/56/EC of the European Parliament and of the Council (4). (4) The objectives of the CFP are, inter alia, to ensure that fishing and aquaculture are environmentally sustainable in the long term, to apply the precautionary approach to fisheries management and to implement the ecosystem-based approach to fisheries management. (5) To achieve the objectives of the CFP, a number of conservation measures are to be adopted, as appropriate, in any combination thereof, such as multiannual plans, technical measures, fixing and allocation of fishing opportunities. (6) Pursuant to Articles 9 and 10 of Regulation (EU) No 1380/2013, multiannual plans are to be based on scientific, technical and economic advice. In accordance with those provisions, the multiannual plan established by this Regulation (\u2018the plan\u2019) should contain objectives, quantifiable targets with clear timeframes, conservation reference points, safeguards and technical measures designed to avoid and reduce unwanted catches. (7) The \u2018best available scientific advice\u2019 should be understood to refer to publicly available scientific advice that is supported by the most up-to-date scientific data and methods and that has either been issued or reviewed by an independent scientific body that is recognised at Union or international level. (8) The Commission should obtain the best available scientific advice for the stocks falling within the scope of the plan. In order to do so, it concludes Memoranda of Understanding with the International Council for the Exploration of the Sea (ICES). The scientific advice issued by ICES should be based on the plan and should indicate, in particular, ranges of FMSY and biomass reference points, i.e. MSY Btrigger and Blim. Those values should be indicated in the relevant stock advice and, where appropriate, in any other publicly-available scientific advice, including, for example, in mixed fisheries advice issued by ICES. (9) Council Regulations (EC) No 676/2007 (5) and (EC) No 1342/2008 (6) set out the rules for the sustainable exploitation of the stocks of cod, plaice and sole in the North Sea and its adjacent waters. Those and other demersal stocks are taken in mixed fisheries. Therefore, it is appropriate to establish a single multiannual plan taking into account such technical interactions. (10) In addition, such a multiannual plan should apply to demersal stocks and their fisheries in the North Sea. Those are roundfish, flatfish and cartilaginous fish species, Norway lobster (Nephrops norvegicus) and Northern prawn (Pandalus borealis) that live at or near the bottom of the water column. (11) Some demersal stocks are exploited both in the North Sea and in its adjacent waters. Therefore the scope of the provisions of the plan relating to targets and safeguards for stocks that are mainly exploited in the North Sea should be extended so that they also cover those areas outside the North Sea. In addition, for stocks which are present in the North Sea, but which are mainly exploited outside the North Sea, it is necessary to establish the targets and safeguards in multiannual plans for areas outside the North Sea where those stocks are mainly exploited, extending the scope of those multiannual plans so that they also cover the North Sea. (12) The geographical scope of the plan should be based on the geographical distribution of stocks indicated in the latest scientific stock advice provided by ICES. Future changes to the geographical distribution of stocks as set out in the plan may be needed either due to improved scientific information or due to migration of stocks. Therefore, the Commission should be empowered to adopt delegated acts adjusting the geographical distribution of stocks set out in the plan if the scientific advice provided by ICES indicates a change in the geographical distribution of the relevant stocks. (13) Where stocks of common interest are also exploited by third countries, the Union should engage with those third countries with a view to ensuring that those stocks are managed in a sustainable manner that is consistent with the objectives of Regulation (EU) No 1380/2013, in particular Article 2(2) thereof, and of this Regulation. Where no formal agreement is reached, the Union should make every effort to reach common arrangements for fishing of such stocks with a view to making sustainable management possible, thereby promoting a level-playing field for Union operators. (14) The objective of the plan should be to contribute to the achievement of the objectives of the CFP, and in particular to reaching and maintaining MSY for the target stocks implementing the landing obligation for demersal stocks subject to catch limits, to promoting a fair standard of living for those who depend on fishing activities, bearing in mind coastal fisheries and socioeconomic aspects, and to implementing the ecosystem-based approach to fisheries management. The plan should also specify details for the implementation of the landing obligation in Union waters of the North Sea for all stocks of species to which the landing obligation applies under Article 15 of Regulation (EU) No 1380/2013. (15) Article 16(4) of Regulation (EU) No 1380/2013 requires that fishing opportunities be fixed in accordance with the objectives set out in Article 2(2) thereof and comply with the targets, time frames and margins established in the multiannual plans. (16) It is appropriate to establish the target fishing mortality (\u2018F\u2019) that corresponds to the objective of reaching and maintaining MSY as ranges of values which are consistent with achieving MSY (FMSY). Those ranges, based on the best available scientific advice, are necessary in order to provide the flexibility to take account of developments in scientific advice, to contribute to the implementation of the landing obligation and to take into account the characteristics of mixed fisheries. The ranges of FMSY should be calculated and provided by ICES, in particular in its periodic catch advice. Based on the plan, they are derived to deliver no more than a 5 % reduction in long-term yield compared to MSY, as set out in ICES' response to the \u2018EU request to ICES to provide ranges of FMSY for selected North Sea and Baltic Sea Stocks\u2019. The upper limit of the range is capped, so that the probability of the stock falling below Blim is no more than 5 %. That upper limit also conforms to the ICES advice rule, which indicates that when the spawning biomass or abundance is in a poor state, F is to be reduced to a value that does not exceed an upper limit equal to the FMSY point value multiplied by the spawning biomass or abundance in the total allowable catch (TAC) year divided by MSY Btrigger. ICES uses those considerations and the advice rule in its provision of scientific advice on fishing mortality and catch options. (17) For the purposes of fixing fishing opportunities, there should be an upper threshold for ranges of FMSY in normal use and, provided that the stock concerned is considered to be in a good state, an upper limit for certain cases. It should be possible to fix fishing opportunities at the upper limit only if, on the basis of scientific advice or evidence, it is necessary to achieve the objectives of this Regulation in mixed fisheries or necessary to avoid harm to a stock caused by intra- or inter-species stock dynamics, or in order to limit the year-to-year variations in fishing opportunities. (18) For stocks for which targets relating to MSY are available, and for the purpose of the application of safeguard measures, it is necessary to establish conservation reference points expressed as trigger spawning biomass levels for fish stocks, and trigger abundance levels for Norway lobster. (19) Appropriate safeguard measures should be provided for in case the stock size falls below those levels. Safeguard measures should include the reduction of fishing opportunities and specific conservation measures when scientific advice states that remedial measures are needed. Those measures should be supplemented by all other appropriate measures such as Commission measures in accordance with Article 12 of Regulation (EU) No 1380/2013 or Member State measures in accordance with Article 13 of that Regulation. (20) It should be possible to set the TAC for Norway lobster in ICES division 2a and subarea 4 as the sum of the catch limits established for each functional unit and of the statistical rectangles outside the functional units within that TAC area. However, this should not preclude the adoption of measures to protect specific functional units. (21) Where the Council takes into account a significant impact of recreational fisheries in the framework of the fishing opportunities for a certain stock, it should be able to set a TAC for commercial catches which takes into account the volume of recreational catches and/or to adopt other measures restricting recreational fisheries such as bag limits and closure periods. (22) In order to comply with the landing obligation established by Article 15(1) of Regulation (EU) No 1380/2013, the plan should provide for additional management measures to be further specified in accordance with Article 18 of that Regulation. (23) In order to avoid the disruptive dislocation of fishing activity which could have a negative impact on the state of the cod stocks, it is appropriate to maintain the system of fishing authorisations linked to a limitation of the total capacity of fishing vessels' engine power in ICES division 7d, as previously applicable under Regulation (EC) No 1342/2008. (24) The deadline for submitting joint recommendations from Member States having a direct management interest should be established, as required by Regulation (EU) No 1380/2013. (25) In accordance with Article 10(3) of Regulation (EU) No 1380/2013, provisions should be established for the assessment by the Commission, by 6 August 2023 and every five years thereafter, of the adequacy and effectiveness of the application of this Regulation based on scientific advice. That period allows for the full implementation of the landing obligation, and for regionalised measures to be adopted, implemented and to show effects on the stocks and fisheries. It is also the minimum period required by scientific bodies. (26) In order to adapt to technical and scientific progress in a timely and proportionate manner, to ensure flexibility and to allow for the evolution of certain measures, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of supplementing this Regulation as regards adjustments concerning the stocks covered by this Regulation following changes in the geographical distribution of the stocks, remedial measures and implementation of the landing obligation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (7). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (27) In order to provide legal certainty, it is appropriate to clarify that temporary cessation measures that have been adopted in order to attain the objectives of the plan can be deemed eligible for support under Regulation (EU) No 508/2014 of the European Parliament and of the Council (8). (28) Regulations (EC) No 676/2007 and (EC) No 1342/2008 should be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject-matter and scope 1. This Regulation establishes a multiannual plan (\u2018the plan\u2019) for the following demersal stocks in Union waters of the North Sea (ICES divisions 2a, 3a and subarea 4), including the fisheries exploiting those stocks, and, where those stocks extend beyond the North Sea, in its adjacent waters: (a) Cod (Gadus morhua) in subarea 4 (North Sea) and divisions 7d (Eastern Channel) and 3a.20 (Skagerrak); (b) Haddock (Melanogrammus aeglefinus) in subarea 4 (North Sea) and divisions 6a (West of Scotland) and 3a.20 (Skagerrak); (c) Plaice (Pleuronectes platessa) in subarea 4 (North Sea) and division 3a.20 (Skagerrak); (d) Saithe (Pollachius virens) in subareas 4 (North Sea) and 6 (Rockall and West of Scotland) and division 3a (Skagerrak and Kattegat); (e) Sole (Solea solea) in subarea 4 (North Sea); (f) Sole (Solea solea) in division 3a (Skagerrak and Kattegat) and subdivisions 22\u201324 (Western Baltic Sea); (g) Whiting (Merlangius merlangus) in subarea 4 (North Sea) and division 7d (Eastern English Channel); (h) Anglerfish (Lophius piscatorius) in division 3a (Skagerrak and Kattegat) and subareas 4 (North Sea) and 6 (Rockall and West of Scotland); (i) Northern Prawn (Pandalus borealis) in divisions 4a East (Northern North Sea, Norwegian Deep) and 3a.20 (Skagerrak); (j) Norway lobster (Nephrops norvegicus) in division 3a (Functional Units 3-4); (k) Norway lobster in subarea 4 (North Sea) by Functional Unit: \u2014 Norway lobster in Botney Gut-Silver Pit (Functional Unit 5); \u2014 Norway lobster in Farn Deeps (Functional Unit 6); \u2014 Norway lobster in Fladen Ground (Functional Unit 7); \u2014 Norway lobster in Firth of Forth (Functional Unit 8); \u2014 Norway lobster in Moray Firth (Functional Unit 9); \u2014 Norway lobster in Noup (Functional Unit 10); \u2014 Norway lobster in Norwegian Deeps (Functional Unit 32); \u2014 Norway lobster in Horn's Reef (Functional Unit 33); \u2014 Norway lobster in Devil's Hole (Functional Unit 34). Where scientific advice indicates a change in the geographical distribution of the stocks listed in the first subparagraph of this paragraph, the Commission may adopt delegated acts in accordance with Article 16 amending this Regulation by adjusting the areas listed in the first subparagraph of this paragraph in order to reflect that change. Such adjustments shall not extend the stock areas beyond Union waters of subareas 2 to 7. 2. Where, on the basis of scientific advice, the Commission considers that the list of stocks set out in the first subparagraph of paragraph 1 needs to be amended, the Commission may submit a proposal for the amendment of that list. 3. With respect to adjacent waters referred to in paragraph 1 of this Article, only Articles 4 and 6 and the measures related to fishing opportunities under Article 7 shall apply. 4. This Regulation also applies to by-catches caught in the North Sea when fishing for the stocks listed in the first subparagraph of paragraph 1. However, where ranges of FMSY and safeguards linked to biomass are established for those stocks under other Union legal acts establishing multiannual plans, those ranges and safeguards shall apply. 5. This Regulation also specifies details for the implementation of the landing obligation in Union waters of the North Sea for all stocks of species to which the landing obligation applies under Article 15 of Regulation (EU) No 1380/2013. Article 2 Definitions For the purposes of this Regulation, the following definitions apply in addition to those laid down in Article 3 of Council Regulation (EC) No 850/98 (9), Article 4 of Council Regulation (EC) No 1224/2009 (10) and Article 4 of Regulation (EU) No 1380/2013: (1) \u2018Range of FMSY\u2019 means a range of values provided for in the best available scientific advice, in particular by the International Council on the Exploration of the Sea (ICES), where all levels of fishing mortality within that range result in maximum sustainable yield (MSY) in the long term with a given fishing pattern and under current average environmental conditions without significantly affecting the reproduction process for the stock in question. It is derived to deliver no more than a 5 % reduction in long-term yield compared to the MSY. It is capped so that the probability of the stock falling below the limit spawning stock biomass reference point (Blim) is no more than 5 %; (2) \u2018MSY Flower\u2019 means the lowest value within the range of FMSY; (3) \u2018MSY Fupper\u2019 means the highest value within the range of FMSY; (4) \u2018FMSY point value\u2019 is the value of the estimated fishing mortality that with a given fishing pattern and under current average environmental conditions gives the long-term MSY; (5) \u2018Lower range of FMSY\u2019 means a range that contains values from MSY Flower up to FMSY point value; (6) \u2018Upper range of FMSY\u2019 means a range that contains values from FMSY point value up to MSY Fupper; (7) \u2018Blim\u2019 means the spawning stock biomass reference point provided for in the best available scientific advice, in particular by ICES, below which there may be reduced reproductive capacity; (8) \u2018MSY Btrigger\u2019 means the spawning stock biomass and, in the case of Norway lobster stocks, the abundance reference point provided for in the best available scientific advice, in particular by ICES, below which specific and appropriate management action is to be taken to ensure that exploitation rates in combination with natural variations rebuild stocks above levels capable of producing MSY in the long term. CHAPTER II OBJECTIVES Article 3 Objectives 1. The plan shall contribute to the achievement of the objectives of the common fisheries policy listed in Article 2 of Regulation (EU) No 1380/2013, in particular by applying the precautionary approach to fisheries management, and shall aim to ensure that exploitation of living marine biological resources restores and maintains populations of harvested species above levels which can produce MSY. 2. The plan shall contribute to the elimination of discards, by avoiding and reducing, as far as possible, unwanted catches, and to the implementation of the landing obligation established in Article 15 of Regulation (EU) No 1380/2013 for the species which are subject to catch limits and to which this Regulation applies. 3. The plan shall implement the ecosystem-based approach to fisheries management in order to ensure that negative impacts of fishing activities on the marine ecosystem are minimised. It shall be coherent with Union environmental legislation, in particular with the objective of achieving good environmental status by 2020 as set out in Article 1(1) of Directive 2008/56/EC. 4. In particular, the plan shall aim to: (a) ensure that the conditions described in descriptor 3 contained in Annex I to Directive 2008/56/EC are fulfilled; and (b) contribute to the fulfilment of other relevant descriptors contained in Annex I to Directive 2008/56/EC in proportion to the role played by fisheries in their fulfilment. 5. Measures under the plan shall be taken in accordance with the best available scientific advice. Where there is insufficient data, a comparable degree of conservation of the relevant stocks shall be pursued. CHAPTER III TARGETS Article 4 Targets 1. The target fishing mortality, in line with the ranges of FMSY defined in Article 2, shall be achieved as soon as possible, and on a progressive, incremental basis by 2020 for the stocks listed in Article 1(1), and shall be maintained thereafter within the ranges of FMSY, in accordance with this Article. 2. The ranges of FMSY based on the plan shall be requested from ICES. 3. In accordance with Article 16(4) of Regulation (EU) No 1380/2013, when the Council fixes fishing opportunities for a stock, it shall establish those opportunities within the lower range of FMSY available at that time for that stock. 4. Notwithstanding paragraphs 1 and 3, fishing opportunities for a stock may be fixed at levels that are lower than the ranges of FMSY. 5. Notwithstanding paragraphs 3 and 4, fishing opportunities for a stock may be fixed in accordance with the upper range of FMSY available at that time for that stock, provided that the stock referred to in Article 1(1) is above MSY Btrigger: (a) if, on the basis of scientific advice or evidence, it is necessary for the achievement of the objectives laid down in Article 3 in the case of mixed fisheries; (b) if, on the basis of scientific advice or evidence, it is necessary to avoid serious harm to a stock caused by intra- or inter-species stock dynamics; or (c) in order to limit variations in fishing opportunities between consecutive years to not more than 20 %. 6. Fishing opportunities shall in any event be fixed in such a way as to ensure that there is less than a 5 % probability of the spawning stock biomass falling below Blim. Article 5 Management of by-catch stocks 1. For the stocks referred to in Article 1(4), management measures including, where appropriate, fishing opportunities, shall be set taking into account the best available scientific advice and shall be consistent with the objectives laid down in Article 3. 2. Those stocks shall be managed under the precautionary approach to fisheries management as defined in point 8 of Article 4(1) of Regulation (EU) No 1380/2013 when no adequate scientific information is available. 3. In accordance with Article 9(5) of Regulation (EU) No 1380/2013, the management of mixed fisheries with regard to stocks referred to in Article 1(4) of this Regulation shall take into account the difficulty of fishing all stocks at MSY at the same time, especially in situations where that leads to a premature closure of the fishery. CHAPTER IV SAFEGUARDS Article 6 Conservation reference points The following conservation reference points to safeguard the full reproductive capacity of the stocks referred to in Article 1(1) shall be requested from ICES based on the plan: (a) MSY Btrigger for stocks referred to in Article 1(1); (b) Blim for stocks referred to in Article 1(1). Article 7 Safeguards 1. When scientific advice indicates that, for a given year, the spawning stock biomass and, in the case of Norway lobster stocks, the abundance of any of the stocks referred to in Article 1(1) are below MSY Btrigger, all appropriate remedial measures shall be adopted to ensure rapid return of the stock or functional unit concerned to levels above those capable of producing MSY. In particular, by way of derogation from Article 4(3) and (5), fishing opportunities shall be fixed at levels consistent with a fishing mortality that is reduced below the upper range of FMSY, taking into account the decrease in biomass. 2. When scientific advice indicates that the spawning stock biomass and, in the case of Norway lobster stocks, the abundance of any of the stocks referred to in Article 1(1) are below the Blim, further remedial measures shall be taken to ensure rapid return of the stock or functional unit concerned to levels above those capable of producing MSY. In particular, those remedial measures may include, by way of derogation from Article 4(3) and (5), suspending the targeted fishery for the stock or functional unit concerned and the adequate reduction of fishing opportunities. 3. Remedial measures referred to in this Article may include: (a) emergency measures in accordance with Articles 12 and 13 of Regulation (EU) No 1380/2013; (b) measures pursuant to Articles 8 and 9 of this Regulation. 4. The choice of measures referred to in this Article shall be made taking into account the nature, seriousness, duration and repetition of the situation where the spawning stock biomass and, in the case of Norway lobster stocks, the abundance are below the levels referred to in Article 6. Article 8 Specific conservation measures When scientific advice indicates that remedial action is required for the conservation of any of the demersal stocks referred to in Article 1(4) of this Regulation, or when the spawning stock biomass and, in the case of Norway lobster stocks, the abundance of any of the stocks covered by Article 1(1) for a given year are below MSY Btrigger, the Commission is empowered to adopt delegated acts in accordance with Article 16 of this Regulation and Article 18 of Regulation (EU) No 1380/2013. Such delegated acts may supplement this Regulation by laying down rules regarding: (a) characteristics of fishing gear, in particular mesh size, hook size, construction of the gear, twine thickness, size of the gear or use of selectivity devices to ensure or improve selectivity; (b) use of the fishing gear, in particular immersion time, depth of gear deployment, to ensure or improve selectivity; (c) prohibition or limitation to fish in specific areas to protect spawning and juvenile fish, fish below the minimum conservation reference size or non-target fish species; (d) prohibition or limitation on fishing or the use of certain types of fishing gear during specific time periods, to protect spawning fish, fish below the minimum conservation reference size or non-target fish species; (e) minimum conservation reference sizes, to ensure the protection of juveniles of marine organisms; (f) other characteristics linked to selectivity. CHAPTER V TECHNICAL MEASURES Article 9 Technical measures 1. The Commission is empowered to adopt delegated acts in accordance with Article 16 of this Regulation and Article 18 of Regulation (EU) No 1380/2013 in order to supplement this Regulation regarding the following technical measures: (a) specifications of characteristics of fishing gears and rules governing their use, to ensure or to improve selectivity, to reduce unwanted catches or to minimise the negative impact on the ecosystem; (b) specifications of modifications or additional devices to the fishing gears, to ensure or to improve selectivity, to reduce unwanted catches or to minimise the negative impact on the ecosystem; (c) limitations or prohibitions on the use of certain fishing gears and on fishing activities, in certain areas or periods to protect spawning fish, fish below the minimum conservation reference size or non-target fish species, or to minimise the negative impact on the ecosystem; and (d) the fixing of minimum conservation reference sizes for any of the stocks to which this Regulation applies, to ensure the protection of juveniles of marine organisms. 2. The measures referred to in paragraph 1 of this Article shall contribute to the achievement of the objectives set out in Article 3. CHAPTER VI FISHING OPPORTUNITIES Article 10 Fishing opportunities 1. When allocating fishing opportunities available to them in accordance with Article 17 of Regulation (EU) No 1380/2013, Member States shall take account of the likely catch composition of vessels participating in mixed fisheries. 2. Member States may, after notifying the Commission, exchange all or part of the fishing opportunities allocated to them pursuant to Article 16(8) of Regulation (EU) No 1380/2013. 3. Without prejudice to Article 7 of this Regulation, the TAC for the stock of Norway lobster in ICES zones 2a and 4 may be the sum of the catch limits of the functional units and of the statistical rectangles outside the functional units. 4. When scientific advice indicates that recreational fisheries have a significant impact on the fishing mortality of a particular stock, the Council shall take them into account and may limit recreational fisheries when fixing fishing opportunities in order to avoid exceeding the total target of fishing mortality. CHAPTER VII PROVISIONS LINKED TO THE LANDING OBLIGATION Article 11 Provisions linked to the landing obligation in Union waters of the North Sea For all stocks of species in the North Sea to which the landing obligation applies under Article 15(1) of Regulation (EU) No 1380/2013, the Commission is empowered to adopt delegated acts in accordance with Article 16 of this Regulation and Article 18 of Regulation (EU) No 1380/2013 in order to supplement this Regulation by specifying details of that obligation as provided for in points (a) to (e) of Article 15(5) of Regulation (EU) No 1380/2013. CHAPTER VIII ACCESS TO WATERS AND RESOURCES Article 12 Fishing authorisations and capacity ceilings 1. For each of the ICES zones referred to in Article 1(1) of this Regulation, each Member State shall issue fishing authorisations in accordance with Article 7 of Regulation (EC) No 1224/2009 for vessels flying its flag and which engage in fishing activities in that area. In such fishing authorisations, Member States may also limit the total capacity expressed in kW of such vessels using a specific gear. 2. For cod in the Eastern Channel (ICES division 7d), without prejudice to the capacity ceilings set out in Annex II to Regulation (EU) No 1380/2013, the total capacity expressed in kW of the vessels having fishing authorisations issued in accordance with paragraph 1 of this Article shall not be greater than the maximum capacity of the vessels that have been active in 2006 or 2007 using one of the following gears in the ICES zone concerned: (a) bottom trawls and seines (OTB, OTT, PTB, SDN, SSC, SPR) of mesh: (i) equal to or larger than 100 mm; (ii) equal to or larger than 70 mm and less than 100 mm; (iii) equal to or larger than 16 mm and less than 32 mm; (b) beam trawls (TBB) of mesh: (i) equal to or larger than 120 mm; (ii) equal to or larger than 80 mm and less than 120 mm; (c) gill nets, entangling nets (GN); (d) trammel nets (GT); (e) longlines (LL). 3. Each Member State shall establish and maintain a list of vessels holding the fishing authorisation referred to in paragraph 1 and make it available on its official website to the Commission and the other Member States. CHAPTER IX MANAGEMENT OF STOCKS OF COMMON INTEREST Article 13 Principles and objectives of management of stocks of common interest to the Union and third countries 1. Where stocks of common interest are also exploited by third countries, the Union shall engage with those third countries with a view to ensuring that those stocks are managed in a sustainable manner that is consistent with the objectives of Regulation (EU) No 1380/2013, in particular Article 2(2) thereof, and of this Regulation. Where no formal agreement is reached, the Union shall make every effort to reach common arrangements for fishing of such stocks with a view to making sustainable management possible, thereby promoting a level-playing field for Union operators. 2. In the context of the joint management of stocks with third countries, the Union may exchange fishing opportunities with third countries pursuant to Article 33(2) of Regulation (EU) No 1380/2013. CHAPTER X REGIONALISATION Article 14 Regional cooperation 1. Article 18(1) to (6) of Regulation (EU) No 1380/2013 shall apply to measures referred to in Articles 8, 9 and 11 of this Regulation. 2. For the purpose of paragraph 1 of this Article, Member States having a direct management interest may submit joint recommendations in accordance with Article 18(1) of Regulation (EU) No 1380/2013 for the first time not later than 6 August 2019 and thereafter 12 months after each submission of the evaluation of the plan in accordance with Article 15 of this Regulation. They may also submit such recommendations when deemed necessary by them, in particular in the event of an abrupt change in the situation for any of the stocks to which this Regulation applies. Joint recommendations in respect of measures concerning a given calendar year shall be submitted no later than 1 July of the previous year. 3. The empowerments granted under Articles 8, 9 and 11 of this Regulation shall be without prejudice to powers conferred to the Commission under other provisions of Union law, including under Regulation (EU) No 1380/2013. CHAPTER XI FOLLOW UP Article 15 Evaluation of the plan By 6 August 2023 and every five years thereafter, the Commission shall report to the European Parliament and to the Council on the results and impact of the plan on the stocks to which this Regulation applies and on the fisheries exploiting those stocks, in particular as regards the achievement of the objectives set out in Article 3. CHAPTER XII PROCEDURAL PROVISIONS Article 16 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 1(1) and Articles 8, 9 and 11 shall be conferred on the Commission for a period of five years from 5 August 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 1(1) and Articles 8, 9 and 11 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 1(1) and Articles 8, 9 and 11 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. CHAPTER XIII SUPPORT FROM THE EUROPEAN MARITIME AND FISHERIES FUND Article 17 Support from the European Maritime and Fisheries Fund Temporary cessation measures adopted in order to achieve the objectives of the plan shall be deemed as a temporary cessation of fishing activities for the purposes of points (a) and (c) of Article 33(1) of Regulation (EU) No 508/2014. CHAPTER XIV FINAL PROVISIONS Article 18 Repeals 1. Regulations (EC) No 676/2007 and (EC) No 1342/2008 are repealed. 2. References made to the repealed Regulations shall be construed as references to this Regulation. Article 19 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 4 July 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) OJ C 75, 10.3.2017, p. 109. (2) Position of the European Parliament of 29 May 2018 (not yet published in the Official Journal) and decision of the Council of 18 June 2018. (3) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (4) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (5) Council Regulation (EC) No 676/2007 of 11 June 2007 establishing a multiannual plan for fisheries exploiting stocks of plaice and sole in the North Sea (OJ L 157, 19.6.2007, p. 1). (6) Council Regulation (EC) No 1342/2008 of 18 December 2008 establishing a long-term plan for cod stocks and the fisheries exploiting those stocks and repealing Regulation (EC) No 423/2004 (OJ L 348, 24.12.2008, p. 20). (7) OJ L 123, 12.5.2016, p. 1. (8) Regulation (EU) No 508/2014 of the European Parliament and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council (OJ L 149, 20.5.2014, p. 1). (9) Council Regulation (EC) No 850/98 of 30 March 1998 for the conservation of fishery resources through technical measures for the protection of juveniles of marine organisms (OJ L 125, 27.4.1998, p. 1). (10) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). Joint Statement by the European Parliament and the Council on prohibited species The Regulation to be adopted on the basis of the Commission proposal on the conservation of fishery resources and the protection of marine ecosystems through technical measures (2016/0074(COD)) should contain provisions, inter alia, on the species for which fishing is prohibited. For that reason the two institutions have agreed not to include a list concerning the North Sea in this Regulation (2016/0238(COD)). Joint Statement by the European Parliament and the Council on control The European Parliament and the Council will include the following control provisions in the upcoming review of the Control Regulation (Regulation (EC) No 1224/2009) where relevant to the North Sea: prior notifications, logbook requirements, designated ports, and other control provisions.", "summary": "Demersal stocks in the North Sea \u2014 Multiannual plan Demersal stocks in the North Sea \u2014 Multiannual plan SUMMARY OF: Regulation (EU) 2018/973 \u2014 establishing a multiannual plan for demersal stocks in the North Sea and the fisheries exploiting those stocks, specifying details of the implementation of the landing obligation in the North Sea WHAT IS THE AIM OF THE REGULATION? It establishes a multiannual plan for demersal* fish populations in the North Sea and the fisheries catching them. KEY POINTS Scope Demersal fish species covered by this regulation include: cod; haddock; plaice; saithe; sole; whiting; anglerfish; northern prawn; Norway lobster. It also covers by-catches* caught when fishing for one of the listed species. Objectives The plan aims to: help the EU and EU countries meet the objectives of the common fisheries policy (CFP), and in particular to ensure that fish species are caught sustainably; contribute to eliminating fish discards* at sea by avoiding and reducing unwanted catches and by implementing the landing obligation for the fish species covered; implement the ecosystem approach to fisheries management to minimise any negative impacts of fishing on the marine environment. It includes: quantifiable targets with clear timeframes; conservation reference points to ensure fish populations can reproduce fully; safeguard measures; technical measures to avoid and reduce unwanted catches; rules on access to waters and resources; principles for managing stocks of common interest to the EU and non-EU countries; strengthened regional cooperation providing a voice to local fisheries; authorisation for the European Commission, on the basis of scientific advice, to adopt delegated acts, to adapt the geographical distribution of the stocks provided for in the plan and to submit a proposal to amend the list of stocks. FROM WHEN DOES THE REGULATION APPLY? It has applied since 5 August 2018. BACKGROUND The EU is a party to the UN Convention on the Law of the Sea. The EU fisheries control system ensures that rules of the CFP are respected. KEY TERMS Demersal: fish species which live on or close to the sea bed. By-catch: unwanted fish and marine species caught unintentionally. Discarding: practice of returning unwanted catches to the sea, either dead or alive, because they are undersized, due to market demand, the fisherman has no quota or because catch composition rules impose this MAIN DOCUMENT Regulation (EU) 2018/973 of the European Parliament and of the Council of 4 July 2018 establishing a multiannual plan for demersal stocks in the North Sea and the fisheries exploiting those stocks, specifying details of the implementation of the landing obligation in the North Sea and repealing Council Regulations (EC) No 676/2007 and (EC) No 1342/2008 (OJ L 179, 16.7.2018, pp. 1-13) Successive amendments to Regulation (EU) 2018/973 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, pp. 22-61) See consolidated version. Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1-50) See consolidated version. Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, pp. 19-40) See consolidated version. last update 20.08.2019"}
{"article": "16.7.2018 EN Official Journal of the European Union L 179/30 REGULATION (EU) 2018/975 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2018 laying down management, conservation and control measures applicable in the South Pacific Regional Fisheries Management Organisation (SPRFMO) Convention Area THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The objective of the Common Fisheries Policy (CFP), as set out in Regulation (EU) No 1380/2013 of the European Parliament and of the Council (3), is to ensure that the exploitation of marine biological resources contributes to long-term environmental, economic and social sustainability. (2) The Union has, by means of Council Decision 98/392/EC (4), approved the United Nations Convention on the Law of the Sea, which contains principles and rules with regard to the conservation and management of the living resources of the sea. In the framework of its wider international obligations, the Union participates in efforts made in international waters to conserve fish stocks. (3) Pursuant to Council Decision 2012/130/EU (5), the Union has been a Contracting Party to the Convention on the Conservation and Management of High Seas Fishery Resources in the South Pacific Ocean (\u2018the SPRFMO Convention\u2019), which established the South Pacific Regional Fisheries Management Organisation (the SPRFMO), since 26 July 2010. (4) Within the SPRFMO, the Commission of the SPRFMO (\u2018the SPRFMO Commission\u2019) is responsible for the adoption of measures designed to ensure the long-term conservation and sustainable use of fishery resources through the application of the precautionary approach to fisheries management and an ecosystem-based approach to fisheries management, and, in so doing, to safeguard the marine ecosystems in which those resources occur. Such measures may become binding upon the Union. (5) It is necessary to ensure that the conservation and management measures adopted by the SPRFMO (\u2018SPRFMO conservation and management measures\u2019) are fully transposed into Union law and are, therefore, uniformly and effectively implemented within the Union. (6) The SPRFMO has the authority to adopt conservation and management measures for the fisheries under its purview, which are binding on the Contracting Parties to the SPRFMO Convention (\u2018Contracting Parties\u2019). Those measures are primarily addressed to the Contracting Parties and provide for obligations for operators such as vessel masters. (7) This Regulation should not cover the fishing opportunities decided by the SPRFMO, as those fishing opportunities are allocated in the framework of the annual Regulation on fishing opportunities adopted pursuant to Article 43(3) of the Treaty on the Functioning of the European Union (TFEU). (8) When implementing the SPRFMO conservation and management measures, the Union and Member States should endeavour to promote the use of fishing gear and techniques which are selective and which have a reduced environmental impact. (9) In order to swiftly incorporate into Union law future binding amendments to the SPRFMO conservation and management measures, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the Annexes to and the relevant Articles of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (6). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (10) To ensure compliance with the CFP, Union legislation has been adopted to establish a system of control, inspection and enforcement, which includes the fight against illegal, unreported and unregulated (IUU) activities. (11) In particular, Council Regulation (EC) No 1224/2009 (7) establishes a Union system for control, inspection and enforcement with a global and integrated approach to ensure compliance with all the rules of the CFP, and Commission Implementing Regulation (EU) No 404/2011 (8) lays down detailed rules for the implementation of Regulation (EC) No 1224/2009. Council Regulation (EC) No 1005/2008 (9) establishes a Community system to prevent, deter and eliminate IUU fishing. Furthermore, Regulation (EU) 2017/2403 of the European Parliament and of the Council (10) lays down rules for issuing and managing fishing authorisations for Union fishing vessels conducting fishing operations in waters under the auspices of a regional fisheries management organisation (RFMO) to which the Union is a contracting party. Those Regulations already implement a number of the provisions laid down in the SPRFMO conservation and management measures. It is therefore not necessary to include those provisions in this Regulation. (12) Article 15(1) of Regulation (EU) No 1380/2013 introduced a landing obligation which applies from 1 January 2015 to fisheries for small and large pelagic species, fisheries for industrial purposes and fisheries for salmon in the Baltic Sea. However, under Article 15(2) of that Regulation, the landing obligation is without prejudice to the Union's international obligations, such as those resulting from the SPRFMO conservation and management measures, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down management, conservation and control provisions relating to fishing for straddling fish stocks in the SPRFMO Convention Area. Article 2 Scope This Regulation shall apply to: (a) Union fishing vessels operating in the SPRFMO Convention Area; (b) Union fishing vessels transhipping fishery products harvested in the SPRFMO Convention Area; (c) third country fishing vessels upon requesting access to, or being the object of an inspection in, Union ports and carrying fishery products harvested in the SPRFMO Convention Area. Article 3 Relationship to other Union acts Except where expressly provided otherwise in this Regulation, this Regulation shall apply without prejudice to Regulations (EC) No 1005/2008, (EC) No 1224/2009 and (EU) 2017/2403. Article 4 Definitions For the purpose of this Regulation, the following definitions shall apply: (1) \u2018SPRFMO Convention Area\u2019 means the geographical area marked out in Article 5 of the SPRFMO Convention; (2) \u2018fishing vessel\u2019 means any vessel of any size used or intended for use for the purposes of commercial exploitation of fishery resources, including support ships, fish processing vessels, vessels engaged in transhipment and carrier vessels equipped for the transportation of fishery products, except container vessels; (3) \u2018Union fishing vessel\u2019 means a fishing vessel flying the flag of a Member State and registered in the Union; (4) \u2018SPRFMO fishery resources\u2019 means all marine biological resources within the SPRFMO Convention Area excluding: (a) sedentary species in so far as they are subject to the national jurisdiction of coastal States pursuant to Article 77, paragraph 4 of the United Nations Convention on the Law of the Sea of 10 December 1982 (\u2018UNCLOS\u2019); (b) highly migratory species listed in Annex I to UNCLOS; (c) anadromous and catadromous species; (d) marine mammals, marine reptiles and sea birds; (5) \u2018SPRFMO fishery products\u2019 means aquatic organisms, or products derived therefrom, resulting from any fishing activity within the SPRFMO Convention Area; (6) \u2018fishing activity\u2019 means searching for fish, shooting, setting, towing, hauling of a fishing gear, taking catch on board, transhipping, retaining on board, processing on board, transferring and landing of fish and fishery products; (7) \u2018bottom fishing\u2019 means the fishing by any fishing vessel using any gear which is likely to come in contact with the seafloor or benthic organisms during the normal course of operations; (8) \u2018bottom fishing footprint\u2019 means the spatial extent of bottom fishing in the SPRFMO Convention Area during the period 1 January 2002 to 31 December 2006; (9) \u2018IUU fishing\u2019 means any illegal, unreported or unregulated fishing activities as defined in points 1 to 4 of Article 2 of Regulation (EC) No 1005/2008; (10) \u2018draft SPRFMO IUU vessel list\u2019 means the initial list of fishing vessels presumed to have undertaken IUU fishing, as drafted by the SPRFMO Secretariat and submitted to the SPRFMO Compliance and Technical Committee forconsideration; (11) \u2018exploratory fishery\u2019 means a fishery that has not been subject to fishing or has not been subject to fishing with a particular gear type or technique in the previous 10 years; (12) \u2018large-scale pelagic driftnet\u2019 means a gillnet or other net, or a combination of nets, which is more than 2,5 kilometres in length the purpose of which is to enmesh, entrap or entangle fish by drifting on the surface or in the water; (13) \u2018deepwater gillnets\u2019 e.g. trammel nets, set nets, anchored nets, sink nets, means strings of single, double or triple netting walls, held vertically, on or near the bottom, in which fish will gill, entangle or enmesh. Deepwater gillnets consist of single or, less commonly, double or triple netting mounted together on the same frame ropes. Several types of nets may be combined in one gear. Those nets can be used either alone or, as is more usual, in large numbers placed in line (\u2018fleets\u2019 of nets). The gear can be set, anchored to the bottom or left drifting, free or connected with the vessel; (14) \u2018SPRFMO Cooperating Non-Contracting Party\u2019 (CNCP) means a State or fishing entity that it is not a party to the SPRFMO Convention but has agreed to fully cooperate in the implementation of the SPRFMO conservation and management measures; (15) \u2018SPRFMO record of vessels\u2019 means the list of fishing vessels authorised to fish in the SPRFMO Convention Area, as notified by the Contracting Parties and CNCPs, which is maintained by the SPRFMO Secretariat; (16) \u2018transhipment\u2019 means the unloading of all or any fishery products on board a fishing vessel to another fishing vessel; (17) \u2018other species of concern\u2019 means species listed in Annex XIII; (18) \u2018vulnerable marine ecosystem\u2019 (VME) means any marine ecosystem the integrity (i.e. ecosystem structure or function) of which is, according to the best scientific information available and to the precautionary principle, threatened by significant adverse impacts resulting from physical contact with bottom gears in the normal course of fishing operations, including reefs, seamounts, hydrothermal vents, cold water corals or cold water sponge beds. TITLE II MANAGEMENT, CONSERVATION AND CONTROL MEASURES CONCERNING CERTAIN SPECIES CHAPTER I Jack mackerel ( Trachurus murphyi ) Article 5 Information on quota exhaustion for jack mackerel Member States shall inform the Commission without delay of the date of the closure of a fishery for jack mackerel that has reached 100 % of its catch limit. The Commission shall promptly transmit that information to the SPRFMO Secretariat. Article 6 Observer coverage in the jack mackerel fishery Member States shall ensure a minimum 10 % scientific observer coverage of trips for fishing vessels flying their flag. For fishing vessels undertaking no more than two trips per year, the 10 % observer coverage shall be calculated by reference to active fishing days for trawlers, and by reference to sets for purse-seiners. Article 7 Data reporting for jack mackerel 1. Member States shall report to the Commission by the 15th day of each month on the catches of jack mackerel from the preceding month, in accordance with Article 33 of Regulation (EC) No 1224/2009. The Commission shall transmit that information to the SPRFMO Secretariat by the 20th day of each month. 2. In addition to paragraph 1, Member States shall report to the Commission the following data regarding jack mackerel fisheries: (a) by the 15th day of each month, the list of fishing vessels flying their flag engaged in transhipment in the preceding month. The Commission shall transmit that information to the SPRFMO Secretariat by the 20th day of each month; (b) not later than 45 days before the SPRFMO Scientific Committee meeting, the annual scientific report covering the previous year. The Commission shall transmit that information to the SPRFMO Secretariat not later than 30 days before the SPRFMO Scientific Committee meeting. Article 8 Allocation of fishing opportunities for jack mackerel In accordance with Article 17 of Regulation (EU) No 1380/2013, when allocating the fishing opportunities for jack mackerel stocks available to them, Member States shall use transparent and objective criteria, including those of an environmental, social and economic nature, and shall also endeavour to distribute national quotas fairly among the various fleet segments, and to provide incentives to Union fishing vessels deploying selective fishing gear or using fishing techniques with reduced environmental impact. CHAPTER II Seabirds Article 9 Seabird mitigation measures for longliners 1. All Union fishing vessels using longlines shall be subject to the seabird mitigation measures set out in this Article. 2. All Union fishing vessels using demersal longlines shall use line weights and tori (bird scaring) lines. 3. Union fishing vessels shall not set longlines during the hours of darkness. 4. Line weighting shall be rigged in accordance with Annex I. 5. Bird scaring lines shall be rigged in accordance with Annex II. 6. Union fishing vessels shall be prohibited from discharging offal during shooting and hauling. Where this is not feasible and when it is necessary to discharge biological waste due to operational safety concerns, vessels shall batch waste for two hours or longer. Article 10 Seabird mitigation measures for trawlers 1. All Union fishing vessels using trawl gear shall be subject to the seabird mitigation measures set out in this Article. 2. Union fishing vessels shall deploy two tori lines while fishing, or, if the operational practices prevent the effective deployment of tori lines, a bird baffler. 3. Bird bafflers shall be rigged in accordance with Annex III. 4. Where possible, Union fishing vessels shall be prohibited from discharging offal during shooting and hauling. 5. Where possible and appropriate, Union fishing vessels shall convert offal into fish meal and retain all waste material with any discharge restricted to liquid discharge/sump water. Where that is not possible and appropriate, fishing vessels shall batch waste for two hours or longer. 6. Where possible, nets shall be cleaned after every fishing operation to remove entangled fish and benthic material to discourage interactions with birds during gear deployment. 7. The time the net is on the water surface during hauling shall be minimised through proper maintenance of winches and good deck practices. Article 11 Seabird data reporting In the annual scientific report referred to in point (b) of Article 7(2) Member States shall indicate: (a) the seabird mitigation measures used by each fishing vessel flying their flag and fishing in the SPRFMO Convention Area; (b) the level of observer coverage dedicated to recording seabird by-catch; (c) any observed seabird interaction data. TITLE III MANAGEMENT, CONSERVATION AND CONTROL MEASURES CONCERNING CERTAIN FISHING METHODS CHAPTER I Bottom fishing Article 12 Bottom fishing authorisation 1. Member States shall not authorise fishing vessels flying their flag to engage in bottom fishing without prior authorisation from the SPRFMO. 2. Member States whose vessels intend to engage in bottom fishing activities in the SPRFMO Convention Area shall submit a request for authorisation to the Commission not later than 45 days before the SPRFMO Scientific Committee meeting at which they wish the request to be considered. The Commission shall forward the request to the SPRFMO Secretariat not later than 30 days before the SPRFMO Scientific Committee meeting. The request shall contain: (a) the bottom fishing footprint, based on the track record in bottom fishing catch or effort in the SPRFMO Convention Area over the period from 1 January 2002 to 31 December 2006 established by the Member State concerned; (b) the average annual catch level over the period 1 January 2002 to 31 December 2006; (c) a bottom fishing impact assessment; (d) an evaluation as to whether the proposed activities both promote the sustainable management of target species and non-target species taken as by-catch, and protect the marine ecosystems in which those resources occur, including by preventing significant adverse impacts on VMEs. 3. The impact assessment referred to in point (c) of paragraph 2 shall be carried out in accordance with the International Guidelines for the Management of Deep-sea Fisheries in the High Seas of the Food and Agriculture Organisation published in 2009 (\u2018Deep-sea Fisheries Guidelines of the FAO\u2019) and shall take into account the SPRFMO Bottom Fishery Impact Assessment Standard and areas where VMEs are known or are likely to occur. 4. The Commission shall inform the relevant Member State of the SPRFMO decision regarding the authorisation to bottom fish in the SPRFMO Convention Area for the purpose of which the impact assessment was conducted, including any attached conditions and relevant measures to prevent significant adverse impacts on VMEs. 5. Member States shall ensure that impact assessments referred to in point (c) of paragraph 2 are updated when a substantial change in the fishery has occurred that is likely to have an impact on VMEs, and shall transmit that information to the Commission as soon as it becomes available. The Commission shall forward that information to the SPRFMO Secretariat. Article 13 Bottom fishing outside the bottom fishing footprint or exceeding reference period catch levels 1. Member States shall not authorise fishing vessels flying their flag to engage in bottom fishing outside the bottom fishing footprint or exceeding reference period catch levels without prior authorisation from the SPRFMO. 2. Member States whose vessels intend to fish outside the bottom fishing footprint or intend to exceed the average annual catch level referred to in point (b) of Article 12(2) shall submit a request for authorisation to the Commission not later than 80 days before the SPRFMO Scientific Committee meeting of the year in which they wish their request to be considered. The Commission shall forward the request to the SPRFMO Secretariat not later than 60 days before the SPRFMO Scientific Committee meeting. The request shall contain: (a) a bottom fishing impact assessment; (b) an evaluation as to whether the proposed activities both promote the sustainable management of target species and non-target species taken as by-catch, and protect the marine ecosystems in which those resources occur, including by preventing significant adverse impacts on VMEs. 3. The impact assessment referred to in point (a) of paragraph 2 shall be carried out in accordance with the Deep-sea Fisheries Guidelines of the FAO and shall take into account the SPRFMO Bottom Fishery Impact Assessment Standard and areas where VMEs are known or are likely to occur. 4. The Commission shall inform the relevant Member State of the SPRFMO decision regarding the authorisation to bottom fish within the SPRFMO Convention Area for the purpose of which the impact assessment was conducted, including any attached conditions and relevant measures to prevent significant adverse impacts on VMEs. 5. Member States shall ensure that impact assessments referred to in point (a) of paragraph 2 are updated when a change in the fishery has occurred that is likely to have an impact on VMEs, and transmit that information to the Commission as soon as it becomes available. The Commission shall forward that information to the SPRFMO Secretariat. Article 14 VMEs in bottom fishing 1. Until the SPRFMO Scientific Committee has developed advice on threshold levels, Member States shall establish threshold levels for encounters with VMEs for fishing vessels flying their flag, taking into account paragraph 68 of the Deep-sea Fisheries Guidelines of the FAO. 2. Member States shall require fishing vessels flying their flag to cease bottom fishing activities within five nautical miles of any site in the SPRFMO Convention Area where encounters exceed the threshold levels established pursuant to paragraph 1 of this Article. Member States shall report encounters with VMEs to the Commission on the basis of the guidelines set out in Annex IV. The Commission shall forward that information to the SPRFMO Secretariat without delay. Article 15 Observer coverage in bottom fishing Member States shall ensure 100 % observer coverage of trawlers flying their flag engaged in bottom fishing and at least 10 % of fishing vessels flying their flag deploying other bottom fishing gear. Article 16 Data reporting for bottom fishing 1. By the 15th day of each month, Member States shall report to the Commission on the catches of bottom fishing species from the preceding month in accordance with Article 33 of Regulation (EC) No 1224/2009. 2. By the 15th day of each month, Member States shall provide to the Commission a list of fishing vessels flying their flag actively fishing and fishing vessels flying their flag engaged in transhipment. The Commission shall forward that information to the SPRFMO Secretariat within five days of receiving it. 3. Member States shall prohibit fishing vessels flying their flag from participating in bottom fishing if the minimum required data regarding fishing vessel identification set out in Annex V have not been provided. CHAPTER II Exploratory fisheries Article 17 Exploratory fisheries authorisation 1. Member States intending to authorise a fishing vessel flying their flag to fish in an exploratory fishery shall submit to the Commission, not later than 80 days in advance of the SPRFMO Scientific Committee meeting: (a) a request for authorisation providing the information contained in Annex V; (b) a Fisheries Operation Plan in accordance with Annex VI, including a commitment to comply with the SPRFMO Data Collection Plan referred to in Article 18(3), (4) and (5). 2. Not later than 60 days in advance of the SPRFMO Scientific Committee meeting, the Commission shall forward the request to the SPRFMO Commission, and the Fisheries Operation Plan to the SPRFMO Scientific Committee. 3. The Commission shall inform the Member State concerned of the SPRFMO decision regarding the authorisation to fish in an exploratory fishery. Article 18 Exploratory fisheries 1. Member States shall not authorise fishing vessels flying their flag to fish in an exploratory fishery without prior authorisation from the SPRFMO. 2. Member States shall ensure that any fishing vessel flying their flag fishes only in an exploratory fishery in accordance with the Fisheries Operation Plan approved by the SPRFMO. 3. Member States shall ensure that the data required by the SPRFMO Data Collection Plan is provided to the Commission, which shall forward those data to the SPRFMO Secretariat. 4. Union fishing vessels authorised to participate in exploratory fisheries shall be prohibited from continuing to fish in the relevant exploratory fishery unless the data specified in the SPRFMO Data Collection Plan has been submitted to the SPRFMO Secretariat for the most recent season in which the fishing occurred and the SPRFMO Scientific Committee has had the opportunity to review that data. 5. Member States whose fishing vessels participate in exploratory fisheries shall ensure that each fishing vessel flying their flag carries one or more independent observers as needed to collect data in accordance with the SPRFMO Data Collection Plan. Article 19 Fishing vessel replacement in exploratory fisheries 1. Notwithstanding Articles 17 and 18, Member States may authorise fishing in an exploratory fishery by a vessel flying their flag which is not identified in the Fisheries Operation Plan if a Union fishing vessel identified in the Fisheries Operation Plan is prevented from fishing on account of legitimate operational or force majeure reasons. In such circumstances, the Member State concerned shall inform the Commission without delay and provide: (a) full details of the intended replacement vessel; (b) a comprehensive account of the reasons for the replacement and any relevant supporting evidence; (c) specifications and a full description of the types of fishing gear to be used by the replacement vessel. 2. The Commission shall transmit that information to the SPRFMO Secretariat without delay. CHAPTER III Large-scale pelagic driftnets, deepwater gillnets and other gillnets Article 20 Large-scale pelagic driftnets and deepwater gillnets The use of large-scale pelagic driftnets and all deepwater gillnets shall be prohibited throughout the SPRFMO Convention Area. Article 21 Gillnets Member States whose vessels intend to transit the SPRFMO Convention Area with gillnets on board shall: (a) give at least 36 hours advance notice to the SPRFMO Secretariat prior to the vessel entering the SPRFMO Convention Area, including the expected entry and exit dates and length of gillnet carried on board; (b) ensure that the vessels flying their flag operate a vessel monitoring system (VMS) reporting once every two hours while in the SPRFMO Convention Area; (c) submit VMS position reports to the SPRFMO Secretariat within 30 days of the vessel leaving the SPRFMO Convention Area; and (d) if gillnets are accidentally lost or fall overboard from the vessel, report the date, time, position and length (metres) of gillnets lost to the SPRFMO Secretariat as soon as possible and in any event within 48 hours of the gear being lost or having fallen overboard. TITLE IV COMMON CONTROL MEASURES CHAPTER I Authorisations Article 22 SPRFMO record of vessels 1. By 15 November each year, Member States shall submit to the Commission a list of fishing vessels flying their flag authorised to fish in the SPRFMO Convention Area for the following year, including the information contained in Annex V. The Commission shall forward that list to the SPRFMO Secretariat. Member States shall take into account the compliance history of fishing vessels and operators when considering the issuance of fishing authorisations for the SPRFMO Convention Area. 2. Member States shall inform the Commission of fishing vessels flying their flag authorised to fish in the SPRFMO Convention Area at least 20 days prior to the date of first entry of such vessels in the SPRFMO Convention Area. The Commission shall transmit that information to the SPRFMO Secretariat at least 15 days prior to the date of first entry in the SPRFMO Convention Area. 3. Member States shall ensure that the data on fishing vessels flying their flag authorised to fish in the SPRFMO Convention Area are up-to-date. Any modification shall be notified to the Commission not later than 10 days after such modification. The Commission shall inform the SPRFMO Secretariat within five days of receiving such notification. 4. In the case of revocation, renunciation or any other circumstances that render an authorisation invalid, Member States shall inform the Commission without delay so that it can transmit that information to the SPRFMO Secretariat within a period of three days following the date of the invalidity of the authorisation. 5. Union fishing vessels not included in the SPRFMO record of vessels shall not be permitted to engage in fishing activities for species under the responsibility of the SPRFMO in the SPRFMO Convention Area. CHAPTER II Transhipment Article 23 General provisions on transhipment 1. This Chapter shall apply to transhipment operations carried out: (a) within the SPRFMO Convention Area in respect of SPRFMO fishery resources, and other species caught in association with these resources, that were harvested in the SPRFMO Convention Area; (b) outside the SPRFMO Convention Area in respect of SPRFMO fishery resources, and other species caught in association with these resources, that were harvested in the SPRFMO Convention Area. 2. Transhipments at sea and in port shall only be undertaken between fishing vessels included in the SPRFMO record of vessels. 3. At sea transfer of fuel, crew, gear or any other supplies in the SPRFMO Convention Area shall only be undertaken between fishing vessels included in the SPRFMO record of vessels. 4. Transhipment operations at sea in respect of SPRFMO fishery resources, and other species caught in association with these resources, that were harvested in the SPRFMO Convention Area, shall be prohibited in Union waters. Article 24 Notification of transhipment of jack mackerel and demersal species 1. Regardless of where the transhipment takes place, in case of transhipment of jack mackerel and demersal species caught in the SPRFMO Convention Area by Union fishing vessels, the authorities of the flag Member State shall simultaneously transmit to the Commission and the SPRFMO Secretariat the following information: (a) a notification of the intention to tranship, which shall indicate a 14-day period in which the transhipment of jack mackerel and demersal species caught in the SPRFMO Convention Area is scheduled to occur, and which shall be received seven days in advance of the first day of the 14-day period; (b) a notification of the actual transhipment, which shall be received at least 12 hours before the estimated time of such activities. Member States may authorise the Union fishing vessel operator to transmit that information directly to the SPRFMO Secretariat by electronic means subject to the simultaneous transmission of the information to the Commission. 2. The notifications referred to in paragraph 1 shall include the relevant information available regarding the transhipment operation, including the estimated date and time, anticipated location, fishery, and information about the Union fishing vessels involved, in accordance with Annex VII. Article 25 Monitoring of transhipment of jack mackerel and demersal species 1. If an observer is on board the unloading or receiving Union fishing vessel, the observer shall monitor the transhipment activities. The observer shall complete the SPRFMO transhipment logsheet in accordance with Annex VIII to verify the quantity and species of the fishery products being transhipped, and shall provide a copy of the logsheet to the competent authorities of the Member State to which the observed vessel is flagged. 2. The Member State to which the fishing vessel is flagged shall submit the observer data of the SPRFMO transhipment logsheet to the Commission within 10 days of the observer debarking. The Commission shall forward those data to the SPRFMO Secretariat within 15 days of the date of debarkation. 3. For the purpose of verifying the quantity and species of the fishery products being transhipped, and in order to ensure that proper verification can occur, the observer on board shall have full access to the observed Union fishing vessel, including crew, gear, equipment, records (including in electronic format) and fish holds. Article 26 Information to be reported after the transhipment of jack mackerel and demersal species 1. Member States whose vessels are involved in the transhipment operation shall notify all the operational details simultaneously to the SPRFMO Secretariat and the Commission in accordance with Annex IX not later than seven days after the transhipment is carried out. 2. Member States may authorise the Union fishing vessel operator to transmit the information referred to in paragraph 1 directly to the SPRFMO Secretariat by electronic means subject to simultaneous transmission of the information to the Commission. Any request for clarification from the SPRFMO Secretariat received by the Union fishing vessel operator shall be forwarded to the Commission. CHAPTER III Data collection and reporting Article 27 Data collection and reporting 1. In addition to the data reporting requirements set out in Articles 7, 11, 14, 16, 18, 25 and 26, Member States whose vessels fish in the SPRFMO Convention Area shall provide the data set out in paragraphs 2 and 3 of this Article to the Commission. 2. By 15 September each year, Member States whose vessels fish in the SPRFMO Convention Area shall report the live weight for all species/species groups caught during the previous calendar year to the Commission. The Commission shall forward that information to the SPRFMO Secretariat by 30 September. 3. By 15 June each year, Member States whose vessels fish in the SPRFMO Convention Area shall report to the Commission the data regarding trawl fishing activity on tow by tow basis; the data on bottom long lining on set by set basis; and the data on landings, including for reefers, and transhipments. The Commission shall forward that information to the SPRFMO Secretariat by 30 June. 4. The Commission may lay down, by means of implementing acts, detailed requirements for the data reporting referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(2). CHAPTER IV Observer programmes Article 28 Observer programmes 1. Member States whose vessels fish in the SPRFMO Convention Area shall establish observer programmes in order to collect the data set out in Annex X. 2. By 15 September each year, Member States whose vessels fish in the SPRFMO Convention Area shall provide the applicable observer data set out in Annex X covering the previous calendar year to the Commission. The Commission shall forward that information to the SPRFMO Secretariat by 30 September. 3. By 15 August each year, Member States whose vessels fish in the SPRFMO Convention Area shall provide an annual report on the implementation of the observer programme in the previous year. The report shall include observer training, programme design and coverage, the type of data collected, and any problems encountered during the year. The Commission shall forward that information to the SPRFMO Secretariat by 1 September. Article 29 Vessel monitoring system 1. The satellite-tracking device installed on board Union fishing vessels shall ensure the automatic transmission to the fisheries monitoring centre (FMC) of the flag Member State of VMS data with a position error which shall be less than 100 metres under normal satellite navigation operating conditions. 2. Member States shall ensure that their FMCs automatically and continuously report the VMS data of vessels flying their flag engaged in fishing in the SPRFMO Convention Area to the SPRFMO Secretariat at least once every hour and that satellite-tracking devices installed on board of vessels flying their flag are capable of reporting VMS data at least every 15 minutes. 3. For the purpose of Article 9(4) of Regulation (EC) No 1224/2009, the SPRFMO Convention Area shall include a zone of 100 nautical miles outside the SPRFMO Convention Area, within which paragraph 1 of this Article shall apply. 4. Member States shall ensure that, for fishing vessels flying their flag, in the event that the antenna of the satellite-tracking device is mounted separately from the physical enclosure, a single common antenna is used for both satellite navigation decoder and transmitter, and the physical enclosure is connected to the antenna using a single length of unbroken cable. CHAPTER V Control of third country fishing vessels in Member State ports Article 30 Points of contact and designated ports 1. A Member State wishing to grant access to its ports to third country fishing vessels carrying SPRFMO fishery products caught in the SPRFMO Convention Area or fishery products originating from such resources that have not been previously landed or transhipped at port or at sea shall: (a) designate the ports to which third country fishing vessels may request entry pursuant to Article 5 of Regulation (EC) No 1005/2008; (b) designate a point of contact for the purposes of receiving prior notice pursuant to Article 6 of Regulation (EC) No 1005/2008; (c) designate a point of contact for the purposes of receiving inspection reports pursuant to Article 11(3) of Regulation (EC) No 1005/2008. 2. Member States shall transmit any changes to the list of designated points of contact and designated ports to the Commission at least 40 days before the changes take effect. The Commission shall forward that information to the SPRFMO Secretariat at least 30 days before the changes take effect. Article 31 Prior notification 1. By way of derogation from Article 6(1) of Regulation (EC) No 1005/2008, port Member States shall require third country fishing vessels intending to land or tranship in their ports SPRFMO fishery resources that have not been previously landed or transhipped to provide, not later than 48 hours before the estimated time of arrival at the port, the following information in accordance with Annex XI: (a) vessel identification (external identification, name, flag, International Maritime Organization (IMO) number, if any, and international radio call sign (IRCS)); (b) name of the designated port to which the fishing vessel seeks entry and the purpose of the port call (landing or transhipment); (c) a copy of the fishing authorisation or, where appropriate, any other authorisation held by the fishing vessel to support operations on SPRFMO fishery products, or to tranship such fishery products; (d) estimated date and time of arrival in port; (e) the estimated quantities in kilograms of each SPRFMO fishery product held on board, with associated catch areas. If no SPRFMO fishery products are held on board, a \u2018nil\u2019 report shall be transmitted; (f) the estimated quantities for each SPRFMO fishery product in kilograms to be landed or transhipped, with associated catch areas; (g) the crew list of the fishing vessel; (h) the dates of the fishing trip. 2. The information provided in accordance with paragraph 1 shall be accompanied by a catch certificate validated in accordance with Chapter III of Regulation (EC) No 1005/2008 if the third country fishing vessel carries on board SPRFMO fishery products. 3. Port Member States may also request any additional information in order to determine whether the fishing vessel has engaged in IUU fishing or related activities. 4. Port Member States may prescribe a longer or shorter notification period than specified in paragraph 1, taking into account, inter alia, the type of fishery product and the distance between the fishing grounds and their ports. In such a case, port Member States shall inform the Commission which shall promptly transmit the information to the SPRFMO Secretariat. Article 32 Authorisation to land or tranship in ports After receiving the relevant information pursuant to Article 31, a port Member State shall decide whether to authorise or deny the third country fishing vessel entry into its port. Where a third country fishing vessel has been denied entry, the port Member State shall inform the Commission which shall forward the information to the SPRFMO Secretariat without delay. Port Member States shall deny entry to fishing vessels included in the SPRFMO list of IUU vessels. Article 33 Port inspections 1. Port Member States shall inspect at least 5 % of landing and transhipment operations relating to SPRFMO fishery products made by third country fishing vessels in their designated ports. 2. Without prejudice to Article 9(2) of Regulation (EC) No 1005/2008, port Member States shall inspect third country fishing vessels when: (a) there is a request from another Contracting Party, CNCP or relevant RFMO that a particular fishing vessel be inspected, particularly where such requests are supported by evidence of IUU fishing by the fishing vessel in question, and there are clear grounds for suspecting that a fishing vessel has engaged in IUU fishing; (b) a fishing vessel has failed to provide complete information as required in Article 31; (c) a fishing vessel has been denied entry or use of a port in accordance with SPRFMO or another RFMO's provisions. Article 34 Inspection procedure 1. This Article shall apply in addition to the rules on the inspection procedure laid down in Article 10 of Regulation (EC) No 1005/2008. 2. Inspectors from Member States shall carry a valid document of identity. They may take copies of any documents considered relevant. 3. Inspections shall be carried out in such a way that the third country fishing vessel suffers the minimum interference and inconvenience, and that degradation of the quality of the catch is avoided to the extent practicable. 4. On completion of the inspection, the vessel master shall be given the opportunity to add any comments or objections to the report and to contact the competent authority of the relevant port Member State in relation to the inspection report. The template for the inspection report is contained in Annex XII. A copy of the report shall be provided to the vessel master. 5. Within 12 working days following the date of completion of the inspection, the port Member State shall transmit to the Commission a copy of the inspection report referred to in Article 10(3) and Article 11(3) of Regulation (EC) No 1005/2008 completed in accordance with Annex XII to this Regulation. The Commission shall forward the report to the SPRFMO Secretariat within 15 working days of the date of completion of the inspection. 6. If the inspection report cannot be transmitted to the Commission for forwarding to the SPRFMO Secretariat within 15 working days, the port Member State shall notify the Commission within sufficient time of the reasons for the delay and when the report will be submitted, in order to allow the Commission to inform the SPRFMO Secretariat within the period of 15 working days. Article 35 Procedure in case of evidence of infringements of SPRFMO conservation and management measures during port inspections 1. If the information collected during the inspection provides evidence that a third country fishing vessel has committed a breach of the SPRFMO conservation and management measures, this Article shall apply in addition to Article 11 of Regulation (EC) No 1005/2008. 2. The competent authorities of the port Member State shall forward a copy of the inspection report to the Commission as soon as possible and in any case within five working days. The Commission shall transmit that report to the SPRFMO Secretariat and to the flag Contracting Party or CNCP point of contact without delay. 3. Port Member States shall promptly notify the action taken in the event of infringements to the competent authority of the flag Contracting Party or CNCP and to the Commission which shall transmit that information to the SPRFMO Secretariat. CHAPTER VI Enforcement Article 36 Alleged infringements of SPRFMO conservation and management measures reported by the Member States Member States shall submit to the Commission any documented information that indicates possible instances of non-compliance by any fishing vessel with SPRFMO conservation and management measures in the SPRFMO Convention Area over the past two years at least 145 days in advance of the annual meeting of the SPRFMO Commission. The Commission shall examine that information and, if appropriate, forward it to the SPRFMO Secretariat at least 120 days in advance of the annual meeting. Article 37 Inclusion of a Union fishing vessel in the draft SPRFMO IUU vessel list 1. If the Commission receives official notification of the inclusion of a Union fishing vessel in the draft SPRFMO IUU vessel list from the SPRFMO Secretariat, it shall transmit the notification, including the supporting evidence and any other documented information provided by the SPRFMO Secretariat, to the flag Member State for comments not later than 45 days in advance of the annual meeting of the SPRFMO Commission. The Commission shall examine and forward that information to the SPRFMO Secretariat at least 30 days in advance of the annual meeting. 2. Once notified by the Commission, the authorities of the flag Member State shall notify the owner of the fishing vessel of its inclusion in the draft SPRFMO IUU vessel list and of the consequences that may result from its inclusion being confirmed in the IUU vessel list adopted by the SPRFMO. Article 38 Measures concerning fishing vessels included in the SPRFMO IUU vessel list 1. On adoption of the SPRFMO IUU vessel list, the Commission shall request the flag Member State to notify the owner of the fishing vessel identified on the SPRFMO IUU vessel list of its inclusion on the list and the consequences which result from being included on the list. 2. A Member State with information indicating a change of name or an IRCS of a fishing vessel appearing on the SPRFMO IUU vessel list shall, as soon as practicable, transmit such information to the Commission. The Commission shall forward that information to the SPRFMO Secretariat without delay. Article 39 Alleged non-compliance reported by the SPRFMO Secretariat 1. If the Commission receives from the SPRFMO Secretariat any information indicating a suspected non-compliance with the SPRFMO Convention and/or SPRFMO conservation and management measures by a Member State, the Commission shall transmit that information to the concerned Member State without delay. 2. The Member State shall provide the Commission with the findings of any investigation undertaken in relation to the allegations of non-compliance and any actions taken to address compliance concerns at least 45 days in advance of the annual meeting of the SPRFMO Commission. The Commission shall forward that information to the SPRFMO Secretariat at least 30 days in advance of the annual meeting. Article 40 Alleged infringements of SPRFMO conservation and management measures reported by a Contracting Party or CNCP 1. Member States shall designate a point of contact for the purpose of receiving port inspection reports from Contracting Parties and CNCPs. 2. Member States shall transmit any changes to the designated point of contact to the Commission at least 40 days before the changes take effect. The Commission shall forward that information to the SPRFMO Secretariat at least 30 days before such changes take effect. 3. If the point of contact designated by a Member State receives an inspection report from a Contracting Party or CNCP providing evidence that a fishing vessel flying the flag of that Member State has committed a breach of the SPRFMO conservation and management measures, the flag Member State shall promptly investigate the alleged infringement and notify the Commission of the status of the investigation, and of any enforcement action that may have been taken, to enable the Commission to inform the SPRFMO Secretariat within three months of receipt of the notification. If the Member State cannot provide the Commission with a status report within three months of the receipt of the inspection report, it shall notify the Commission within the three month period of the reasons for the delay and of the date by which the status report will be submitted. The Commission shall transmit the information regarding the status or delay of the investigation to the SPRFMO Secretariat. Article 41 Technical failure of the satellite-tracking device 1. In case of technical failure of their satellite-tracking device, Union fishing vessels shall report the following data to the FMC of the Member State to which they are flagged every four hours, by appropriate telecommunication means: (a) IMO number; (b) IRCS; (c) vessel name; (d) vessel master's name; (e) position (latitude and longitude), date and time (UTC); (f) activity (fishing/transit/transhipping). 2. Member States shall ensure that, in the event that the technical failure of the satellite tracking device has not been solved within 60 days from the commencement of the reporting obligation as specified in paragraph 1, fishing vessels flying their flag cease fishing, stow all fishing gear and return to port without delay to repair the satellite-tracking device. 3. Paragraphs 1 and 2 of this Article shall apply in addition to the requirements laid down in Article 25 of Regulation (EU) No 404/2011. TITLE V FINAL PROVISIONS Article 42 Confidentiality Data collected and exchanged in the framework of this Regulation shall be treated in accordance with the rules on confidentiality set out in Articles 112 and 113 of Regulation (EC) No 1224/2009. Article 43 Procedure for amendments In order to incorporate into Union law amendments to SPRFMO conservation and management measures, the Commission shall be empowered to adopt delegated acts in accordance with Article 44 amending: (a) the Annexes to this Regulation; (b) the time limits laid down in Articles 7(1) and (2), 11, 12(2), 13(2), 16(1) and (2), 17(1) and (2), 22(1) to (4), 24(1), 25(2), 26(1), 27(2) and (3), 28(2) and (3), 29(1), 30(2), 31(1), 34(5) and (6), 35(2) and (3), 36, 37(1), 39(2), 40(2) and (3), and 41(1) and (2). (c) observer coverage laid down in Articles 6 and 15; (d) the reference period to determine the bottom fishing footprint in Article 12(2); (e) the inspection coverage laid down in Article 33(1); (f) the type of data and information requirements laid down in Articles 7(2), 11, 12(2) and (3), 13(2) and (3), 14(1), 16(1) and (2), 17(1), 18(2) and (3), 19(1), 24(1), 25(2), 27(2) and (3), 28(3), 31(1) and 41(1). Article 44 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 43 shall be conferred on the Commission for a period of five years from 19 July 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 43 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 43 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. Article 45 Committee procedure 1. The Commission shall be assisted by the Committee for Fisheries and Aquaculture established by Article 47 of Regulation (EU) No 1380/2013. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 46 Entry into force This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 4 July 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) OJ C 288, 31.8.2017, p. 129. (2) Position of the European Parliament of 29 May 2018 (not yet published in the Official Journal) and decision of the Council of 18 June 2018. (3) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (4) Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 1). (5) Council Decision 2012/130/EU of 3 October 2011 on the approval, on behalf of the European Union, of the Convention on the Conservation and Management of High Seas Fishery Resources in the South Pacific Ocean (OJ L 67, 6.3.2012, p. 1). (6) OJ L 123, 12.5.2016, p. 1. (7) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (8) Commission Implementing Regulation (EU) No 404/2011 of 8 April 2011 laying down detailed rules for the implementation of Council Regulation (EC) No 1224/2009 establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy (OJ L 112, 30.4.2011, p. 1). (9) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (10) Regulation (EU) 2017/2403 of the European Parliament and of the Council of 12 December 2017 on the sustainable management of external fishing fleets, and repealing Council Regulation (EC) No 1006/2008 (OJ L 347, 28.12.2017, p. 81). ANNEX I Line weighting standards Vessels shall use a longline weighting regime that achieves a demonstrable minimum longline sink rate of 0,3 metre/second to 15 metre depth for gear. In particular: (a) external weighted lines in Spanish system and trot lines shall use a minimum of 8,5 kg mass at intervals of no more than 40 m if rocks are used, 6 kg mass at intervals of no more than 20 m for concrete weights, and 5 kg weights at intervals of no more than 40 m for solid metal weights; (b) external weighted lines in autoline shall use a minimum 5 kg mass at intervals no more than 40 m, which shall be released from vessels in a manner that avoids tension astern (tension astern may lift sections of the longline already deployed out of the water); (c) Internal weighted lines shall have a lead core of at least 50 g/m. ANNEX II Bird scaring lines specifications Two bird scaring lines shall be carried at all times and shall be deployed whenever fishing gear is being set from the vessel. In particular: (a) bird scaring lines shall be attached to the vessel so that when deployed the baits are protected by the streamer line, even in cross winds; (b) bird scaring lines shall use brightly coloured streamers long enough to reach the sea surface in calm conditions (\u2018long streamers\u2019) placed at intervals of no more than 5 m for at least the first 55 m of streamer line and shall be attached to the line with swivels that prevent streamers from wrapping around the line; (c) bird scaring lines may also use streamers a minimum of 1 m in length (\u2018short streamers\u2019) placed at intervals of no more than 1 m; (d) if bird scaring lines breaks or is damaged while in use, they shall be repaired or replaced so that the vessel meets these specifications before any further hooks enter the water; (e) bird scaring lines shall be deployed so that: (i) they remain above the water surface when the hooks have sunk to a depth of 15 m, or (ii) they have a minimum length of 150 m when extended and suspended from a point on the vessel at least 7 m above the water in the absence of swell. ANNEX III Bird baffler specifications A bird baffler consists of two or more booms attached to the stern quarter of the vessel, with at least one boom attached to the starboard stern quarter and at least one boom attached to the port stern quarter: (a) each boom shall extend a minimum of 4 m outwards from the side or stern of the vessel; (b) dropper lines shall be attached to the booms no more than 2 m apart; (c) plastic cones, rods or other brightly coloured and durable material shall be attached to the ends of the dropper lines so that the bottom of the cone, rod or material is not more than 500 mm above the water, in the absence of wind and swell; (d) lines or webbing may be attached between the dropper lines to prevent tangling. ANNEX IV Guidelines for the preparation and submission of notifications of encounters with VMEs 1. General information Include contact information, flag, vessel name(s) and dates of data collection. 2. VME location Indicate start and end positions of all gear deployments and observations. Provide maps of fishing locations, underlying bathymetry or habitat and spatial scale of fishing. Indicate depth(s) fished. 3. Fishing gear Indicate fishing gears used at each location. 4. Additional data collected Indicate additional data collected at or near the locations fished, if possible. Data such as multibeam bathymetry, oceanographic data such as CTD profiles, current profiles, water chemistry, substrate types recorded at or near those locations, other fauna observed, video recordings, acoustic profiles etc. 5. VME taxa For each station fished, provide details of VME taxa observed, including their relative density, absolute density, or number of organisms if possible. ANNEX V Standards for vessel data 1. The following fields of data shall be collected pursuant to Articles 16, 17 and 22: (i) Current vessel flag and name of vessel (ii) Registration number (iii) IRCS (if any) (iv) UVI (Unique Vessel Identifier)/IMO number (v) Previous names (if known) (vi) Port of registry (vii) Previous flag (viii) Type of vessel (ix) Type of fishing method(s) (x) Length (xi) Length type e.g. \u2018LOA\u2019, \u2018LBP\u2019 (xii) Gross tonnage \u2013 GT (to be provided as the preferred unit of tonnage) (xiii) Gross registered tonnage \u2013 GRT (to be provided if GT not available; may also be provided in addition to GT) (xiv) Power of main engine(s) (kw) (xv) Hold capacity (m3) (xvi) Freezer type (if applicable) (xvii) Number of freezer units (if applicable) (xviii) Freezing capacity (if applicable) (xix) Vessel communication types and numbers (INMARSAT A, B and C numbers); (xx) VMS system details (brand, model, features and identification); (xxi) Name of owner(s) (xxii) Address of owner(s) (xxiii) Vessel authorisation start date (xxiv) Vessel authorisation end date (xxv) Date of inclusion in the SPRFMO record of vessels (xxvi) Good quality high resolution photograph of the vessel of appropriate brightness and contrast, no older than five years, which shall consist of: \u2014 one photograph not smaller than 12 \u00d7 7 cm showing the starboard side of the vessel displaying its full overall length and complete structural features; \u2014 one photograph not smaller than 12 \u00d7 7 cm showing the port side of the vessel displaying its full overall length and complete structural features; \u2014 one photograph not smaller than 12 \u00d7 7 cm showing the stern taken directly from astern. 2. The following information is to be provided if available when practicable: (i) External markings (such as vessel name, registration number or IRCS) (ii) Types of fish processing lines (if applicable) (iii) Date of construction (iv) Place of construction (v) Moulded depth (vi) Beam (vii) Electronic equipment on board (for example radio, echo sounder, radar, netsonda) (viii) Name of licence owner(s) (if different from vessel owner) (ix) Address of licence owner(s) (if different from vessel owner) (x) Name of operator(s) (if different from vessel owner) (xi) Address of operator(s) (if different from vessel owner) (xii) Name of vessel master (xiii) Nationality of vessel master (xiv) Name of fishing master (xv) Nationality of fishing master ANNEX VI Fisheries Operation Plan for exploratory fisheries The Fisheries Operation Plan shall include the following information, to the extent it is available: (i) a description of the exploratory fishery, including area, target species, proposed methods of fishing, proposed maximum catch limits and any apportionment of that catch limit among areas or species; (ii) specification and full description of the types of fishing gear to be used, including any modifications made to gear intended to mitigate the effects of the proposed fishing on non-target and associated or dependent species or the marine ecosystem in which the fishery occurs; (iii) the time period covered by the Fisheries Operation Plan (up to a maximum period of three years); (iv) any biological information on the target species from comprehensive research or survey cruises, such as distribution, abundance, demographic data and information on stock identity; (v) details of non-target and associated or dependent species and the marine ecosystem in which the fishery occurs, the extent to which these would likely be affected by the proposed fishing activity and any measures that will be taken to mitigate these effects; (vi) the anticipated cumulative impact of all fishing activity in the area of the exploratory fishery if applicable; (vii) information from other fisheries in the region or similar fisheries elsewhere that may assist in the evaluation of the relevant exploratory fishery's potential yield, to the extent the Member State is able to provide that information; (viii) if the proposed fishing activity is bottom fishing, the assessment of the impact of bottom fishing activities of vessels flying the flag of the Member State in question, in line with Articles 12 and 13; (ix) where the target species is also managed by an adjacent RFMO to the SPRFMO or similar organisation, a description of that neighbouring fishery sufficient to allow the SPRFMO Scientific Committee to formulate its advice. ANNEX VII Prior transhipment notification Member States shall provide the following information in accordance with Article 24(1): Details of unloading vessel (a) Name of vessel (b) Registration number (c) IRCS (d) Vessel flag state (e) IMO number/IHS Fairplay number (if applicable) (f) Name and nationality of the vessel master Details of receiving vessel (a) Name of vessel (b) Registration number (c) IRCS (d) Vessel flag state (e) IMO number/IHS Fairplay number (if applicable) (f) Name and nationality of vessel master ANNEX VIII Transhipment information to be provided by the observer The following information shall be provided by the observer monitoring transhipment, in accordance with Article 25(1). I. Details of the unloading fishing vessel Name of vessel Registration number IRCS Vessel flag state IMO number/IHS Fairplay number (if applicable) Name and nationality of vessel master II. Details of the receiving fishing vessel Name of vessel Registration number IRCS Vessel flag state IMO number/IHS Fairplay number (if applicable) Name and nationality of vessel master III. Transhipment operation Date and time of commencement of transhipment (UTC) Date and time of completion of transhipment (UTC) If transhipment at sea: Position (nearest 1/10th degree) at commencement of transhipment; If transhipment in port: Name, country, and code (1) of port If transhipment at sea: Position (nearest 1/10th degree) at completion of transhipment Description of product type by species (such as whole, frozen fish in 20 kg cartons) Species Product type Species Product type Species Product type Number of cartons, net weight (kg) of product, by species. Species Cartons Net weight Species Cartons Net weight Species Cartons Net weight Species Cartons Net weight Total net weight of product transhipped (kg) Hold numbers in reefer vessel in which product is stowed Destination port and country of receiving fishing vessel Estimated arrival date Estimated landing date IV. Observations (if applicable) V. Verification Name of observer Authority Signature and stamp (1) United Nations Code for Trade and Transport Locations (UN/LOCODE). ANNEX IX Transhipment information to be reported after the operation In accordance with Article 26(1) flag Member States shall report the following information to the Commission not later than seven days after the transhipment is carried out: Details of unloading vessel (a) Name of vessel (b) Registration number (c) IRCS (d) Vessel flag state (e) IMO number/IHS Fairplay number (if applicable) (f) Name and nationality of vessel master Details of receiving vessel (a) Name of vessel (b) Registration number (c) IRCS (d) Vessel flag state (e) IMO number/IHS Fairplay number (if applicable) (f) Name and nationality of vessel master Details of transhipment operation (a) Date and time of commencement of transhipment (UTC) (b) Date and time of completion of transhipment (UTC) (c) If transhipped in port: port state, name of port and port code (d) If transhipped at sea: (i) Position (nearest 1/10th degree) at commencement of transhipment (decimal) (ii) Position (nearest 1/10th degree) at completion of transhipment (decimal) (e) Hold numbers in receiving vessel in which product is stowed (f) Destination port of receiving vessel (g) Arrival date estimate (h) Landing date estimate Details of fishery resources transhipped (a) Species transhipped (i) Description of fish, by product type (such as whole, frozen fish) (ii) Number of cartons and net weight (kg) of product, by species (iii) Total net weight of product transhipped (kg) (b) Fishing gear used by the unloading vessel Verification (if applicable) (a) Name of observer (b) Authority ANNEX X Observer data Vessel and observer details are to be recorded only once for each observed trip, and shall be reported in a way that links the vessel data to data required in Sections A, B, C, and D. A. Vessel and observer data to be collected for each observed trip 1. The following vessel data are to be collected for each observed trip: (a) Current vessel flag (b) Name of vessel (c) Name of the vessel master (d) Name of the fishing master (e) Registration number (f) IRCS (if any) (g) Lloyd's/IMO number (if allocated) (h) Previous names (if known) (i) Port of registry (j) Previous flag (if any) (k) Type of vessel (use appropriate ISSCFV codes) (l) Type of fishing method(s) (use appropriate ISSCFG codes) (m) Length (m) (n) Length type e.g. \u2018LOA\u2019, \u2018LBP\u2019 (o) Beam (m) (p) Gross tonnage \u2013 GT (to be provided as the preferred unit of tonnage) (q) Gross register tonnage \u2013 GRT (to be provided if GT not available; may also be provided in addition to GT) (r) Power of main engine(s) (kilowatts) (s) Hold capacity (cubic metres) (t) Record of the equipment on board which may affect fishing power factors (navigational equipment, radar, sonar systems, weather fax or satellite weather receiver, sea-surface temperature image receiver, Doppler current monitor, radio direction finder), where practical (u) Total number of crew (all staff, excluding observers) 2. The following observer data are to be collected for each observed trip: (a) Observer's name (b) Observer's organisation (c) Date observer embarked (UTC date) (d) Port of embarkation (e) Date observer disembarked (UTC date) (f) Port of disembarkation B. Catch and effort data to be collected for trawl fishing activity 1. Data are to be collected on an un-aggregated (tow by tow) basis for all observed trawls. 2. The following data are to be collected for each observed trawl tow: (a) Tow start date and time (the time gear starts fishing \u2013 UTC) (b) Tow end date and time (the time haul back starts \u2013 UTC) (c) Tow start position (Lat/Lon, 1 minute resolution \u2013 decimal) (d) Tow end position (Lat/Lon, 1 minute resolution \u2013 decimal) (e) Intended target species (FAO species code) (f) Type of trawl, bottom or mid-water (use appropriate bottom or midwater trawl codes from the standard ISCCFG fishing gear standards) (g) Type of trawl: single, double or triple (S, D or T) (h) Height of net opening (i) Width of net opening (j) Mesh size of the cod-end net (stretched mesh, mm) and mesh type (diamond, square, etc.) (k) Gear depth (of footrope) at start of fishing (l) Bottom (seabed) depth at start of fishing (m) Estimated catch of all species (FAO species code) retained on board, split by species, in live weight (to the nearest kg) (n) Were any marine mammals, seabirds, reptiles or other species of concern caught? (Yes/No/Unknown) If yes, record the numbers by species of all marine mammals, seabirds, reptiles or other species of concern caught. (o) Was there any benthic material in the trawl? (Yes/No/Unknown) If yes, record sensitive benthic species in the trawl catch, particularly vulnerable or habitat-forming species such as sponges, sea-fans or corals. (p) Estimate of the amount (weight or volume) of remaining marine resources not recorded under point (m), (n) or (o) discarded, split to the lowest known taxon (q) Record any by-catch mitigation measures employed: (i) Were bird scaring (tori) lines in use? (nil/equipment code \u2013 as described in Section L) (ii) Were bird bafflers in use? (nil/equipment code \u2013 as described in Section N) (iii) Describe the offal/discard discharge management in place (select all that apply: no discharge during shooting and hauling/only liquid discharge/waste batching > 2 hours/other/none) (iv) Were any other measures used to reduce the by-catch of marine mammals, seabirds, reptiles or other species of concern? (Yes/No) If yes, describe. C. Catch and effort data to be collected for purse seine fishing activity 1. Data are to be collected on an un-aggregated (set by set) basis for all observed purse-seine sets. 2. The following data are to be collected for each observed purse-seine set: (a) Total search time before this set, since the last set (b) Set start date and time (the time gear starts fishing \u2013 UTC) (c) Set end date and time (the time haul back starts \u2013 UTC) (d) Set start position (Lat/Lon, 1 minute resolution \u2013 decimal) (e) Net length (m) (f) Net height (m) (g) Net mesh size (stretched mesh, mm) and mesh type (diamond, square, etc.) (h) Intended target species (FAO species code) (i) Estimated catch of all species (FAO species code) retained on board, split by species, in live weight (to the nearest kg) (j) Were any marine mammals, seabirds, reptiles or other species of concern caught? (Yes/No/Unknown) If yes, record the numbers by species of all marine mammals, seabirds, reptiles or other species of concern caught. (k) Was there any benthic material in the net? (Yes/No/Unknown) If yes, record sensitive benthic species in the catch, particularly vulnerable or habitat-forming species such as sponges, sea-fans or corals. (l) Estimate of the amount (weight or volume) of remaining marine resources not recorded under point (i), (j) or (k) discarded, split to the lowest known taxon (m) Record and describe any by-catch mitigation measures employed D. Catch and effort data to be collected for bottom long line fishing activity 1. Data are to be collected on an un-aggregated (set by set) basis for all observed longline sets. 2. The following fields of data are to be collected for each observed set: (a) Set start date and time (UTC format) (b) Set end date and time (UTC format) (c) Set start position (Lat/Lon, 1 minute resolution \u2014 decimal format) (d) Set end position (Lat/Lon, 1 minute resolution \u2014 decimal format) (e) Intended target species (FAO species code) (f) Total length of longline set (km) (g) Number of hooks for the set (h) Bottom (seabed) depth at start of set (i) Number of hooks actually observed (including for marine mammals, seabirds, reptiles or other species of concern caught) during the haul (j) Estimated catch of all species (FAO species code) retained on board, split by species, in live weight (to the nearest kg) (k) Were any marine mammals, seabirds, reptiles or other species of concern caught? (Yes/No/Unknown) If yes, record the numbers by species of all marine mammals, seabirds, reptiles or other species of concern caught. (l) Was there any benthic material in the catch? (Yes/No/Unknown) If yes, record sensitive benthic species in the catch, particularly vulnerable or habitat-forming species such as sponges, sea-fans or corals. (m) Estimate of the amount (weight or volume) of remaining marine resources not recorded under point (j), (k) or (l) discarded, split to the lowest known taxon (n) Record any bycatch mitigation measures employed: (i) Were bird scaring (tori) lines in use? (nil/equipment code \u2013 as described in Section L) (ii) Was setting restricted to the time between nautical dusk and nautical dawn? (Yes/No) (iii) What type of fishing gear was used? (external weighting system/internal weighting system/trot line/other) (iv) If external weighting system, describe weighting and float regime (using the form provided in Section M) (v) If internal weighting system, what was the line core's weight (grams per metre)? (vi) If trot line, were cachalotera nets used? (Yes/No) (vii) If other, describe (o) What haul mitigation was used? (bird deterrent curtains/other/none) If other, describe. (p) What was the bait type? (fish/squid/mixed; live/dead/mixed; frozen/thawed/mixed) (q) Describe discharge of any biological material during shooting and hauling (discharge not batched for two hours or more/discharge batched for two hours or more/none/unknown) (r) Were any other measures used to reduce the bycatch of marine mammals, seabirds, reptiles or other species of concern? (Yes/No) If yes, describe. E. Length-frequency data to be collected Representative and randomly sampled length-frequency data are to be collected for the target species and, time permitting, for other main by-catch species. Length data are to be collected and recorded at the most precise level appropriate for the species (cm or mm and whether to the nearest unit or unit below) and the type of measurement used (total length, fork length, or standard length) is also to be recorded. If possible, the total weight of length-frequency samples is to be recorded, or estimated and the method of estimation recorded, and observers may be required to also determine sex of measured fish to generate length-frequency data stratified by sex. 1. Commercial sampling protocol (a) Fish species other than skates, rays and sharks: (i) fork length is to be measured to the nearest cm for fish which attain a maximum length greater than 40 cm fork length (ii) fork length is to be measured to the nearest mm for fish which attain a maximum length less than 40 cm fork length; (b) Skates and rays: Maximum disk width is to be measured; (c) Sharks: Appropriate length measurement to be used is to be selected for each species (see FAO technical report 474 on measuring sharks). As a default, total length is to be measured. 2. Scientific sampling protocol For scientific sampling of species, length measurements may need to be made at a finer resolution than specified in point 1. F. Biological sampling to be conducted 1. The following biological data are to be collected for representative samples of the main target species and, time permitting, for other main by-catch species contributing to the catch: (a) Species (b) Length (mm or cm), with a record of the type of length measurement used. Measurement precision and type are to be determined on a species by species basis consistent with that defined in Section E (c) Sex (male, female, immature, unsexed) (d) Maturity stage 2. Observers are to collect tissue, otolith and/or stomach samples according to pre- determined specific research programmes implemented by the SPRFMO Scientific Committee or other national scientific research. 3. Observers are to be briefed and provided with written length-frequency and biological sampling protocols, where appropriate, and priorities for the above sampling specific to each observer trip. G. Data to be collected on incidental captures of seabirds, mammals, turtles and other species of concern 1. The following data are to be collected for all seabirds, mammals, reptiles (turtles) and other species of concern caught in fishing operations: (a) Species (identified taxonomically as far as possible, or accompanied by photographs if identification is difficult) and size (b) Count of the number of each species caught per tow or set (c) Fate of by-caught animal(s) (retained or released/discarded) (d) If released, life status (vigorous, alive, lethargic, dead) upon release (e) If dead, then collect adequate information or samples for onshore identification in accordance with pre-determined sampling protocols. Where this is not possible, observers may be required to collect sub-samples of identifying parts, as specified in biological sampling protocols. (f) Record the type of interaction (hook/line entanglement/warp strike/net capture/other) If other, provide a description. 2. Record sex of each individual for taxa where this is feasible from external observation, such as pinnipeds, small cetaceans or Elasmobranchii and other species of concern. 3. Were there any circumstances or actions that may have contributed to the by-catch event? (for example tori line tangle, high levels of bait loss). H. Detection of fishing in association with VMEs For each observed trawl, the following data are to be collected for all sensitive benthic species caught, particularly vulnerable or habitat-forming species such as sponges, sea fans, or corals: (a) Species (identified taxonomically as far as possible, or accompanied by a photograph where identification is difficult); (b) An estimate of the quantity (weight (kg) or volume (m3)) of each listed benthic species caught in the tow; (c) An overall estimate of the total quantity (weight (kg) or volume (m3)) of all invertebrate benthic species caught in the tow; (d) Where possible, and particularly for new or scarce benthic species which do not appear in guides for the identification of species, whole samples are to be collected and suitably preserved for identification on shore. I. Data to be collected for all tag recoveries The following data are to be collected for all recovered fish, seabird, mammal or reptile tags if the organism is dead, to be retained, or alive: (a) Observer name (b) Vessel name (c) Vessel call sign (d) Vessel flag (e) Collect, label (with all details below) and store the actual tags for later return to the tagging agency (f) Species from which tag recovered (g) Tag colour and type (spaghetti, archival) (h) Tag numbers (The tag number is to be provided for all tags when multiple tags were attached to one fish. If only one tag was recorded, a statement is required that specifies whether or not the other tag was missing.) If the organism is alive and to be released, tag information is to be collected in accordance with predetermined sampling protocols. (i) Date and time of capture (UTC) (j) Location of capture (Lat/Lon, to the nearest 1 minute) (k) Animal length/size (cm or mm) with description of what measurement was taken (such as total length, fork length, etc.). Length measurements are to be collected according to the criteria defined in Section E. (l) Sex (F = female, M = male, I = indeterminate, D = not examined) (m) Whether the tags were found during a period of fishing that was being observed (Yes/No) (n) Reward information (e.g. name and address where to send reward) (It is recognised that some of the data recorded here duplicates data that already exists in the previous categories of information. This is necessary because tag recovery information may be sent separately to other observer data.) J. Hierarchies for observer data collection 1. Recognising that observers may not be able to collect all of the data described in these standards on each trip, a hierarchy of priorities is to be implemented for collection of observer data. Trip-specific or programme-specific observer task priorities may be developed in response to specific research programme requirements, in which case such priorities are to be followed by observers. 2. In the absence of trip- or programme-specific priorities, the following generalised priorities are to be followed by observers: (a) Fishing Operation Information All vessel and tow/set/effort information (b) Reporting of Catches (i) Record time, weight of catch sampled versus total catch or effort (e.g. number of hooks), and total numbers of each species caught (ii) Identification and counts of seabirds, mammals, reptiles (turtles), sensitive benthic species and vulnerable species (iii) Record numbers or weights of each species retained or discarded (iv) Record instances of depredation, where appropriate (c) Biological Sampling (i) Check for presence of tags (ii) Length-frequency data for target species (iii) Basic biological data (sex, maturity) for target species (iv) Length-frequency data for main by-catch species (v) Otoliths (and stomach samples, if being collected) for target species (vi) Basic biological data for by-catch species (vii) Biological samples of by-catch species (if being collected) (viii) Take photos (d) The reporting of catches and biological sampling procedures are to be prioritised among species groups as follows: Species Priority (1 highest) Primary target species (such as jack mackerel, for pelagic fisheries, and orange roughy for demersal fisheries) 1 Seabirds, mammals, reptiles (turtles) or other species of concern 2 Other species typically within top 5 in the fishery (such as blue mackerel for pelagic fisheries, and oreos and alfonsino for demersal fisheries) 3 All other species 4 The allocation of observer effort among these activities will depend on the type of operation and setting. The size of sub-samples relative to unobserved quantities (such as the number of hooks examined for species composition relative to the number of hooks set) is to be explicitly recorded under the guidance of Member State observer programmes. K. Coding specifications to be used for recording observer data 1. Unless otherwise specified for specific data types, observer data are to be provided in accordance with the same coding specifications as specified in this section. 2. Coordinated Universal Time (UTC) is to be used to describe times. 3. Decimal degrees are to be used to describe locations. 4. The following coding schemes are to be used: (a) species are to be described using the FAO 3 letter species codes; (b) fishing methods are to be described using the International Standard Classification of Fishing Gear (ISSCFG \u2013 29 July 1980) codes; (c) types of fishing vessel are to be described using the International Standard Classification of Fishery Vessels (ISSCFV) codes. 5. Metric units of measure are to be used, specifically: (a) kilograms are to be used to describe catch weight; (b) metres are to be used to describe height, width, depth, beam or length; (c) cubic metres are to be used to describe volume; (d) kilowatts are to be used to describe engine power. L. Bird scaring line description form General Bird Scaring Line Description: Trip Number Bird scaring line position Bird scaring line equipment code Distance between streamers (m) Number of streamers (e.g. 7 in this diagram) Streamer length min/max (m) Bird scaring line design: (Design shown is paired) Bird scaring line material Attached height above water (m) Backbone length (m) Towed object Streamer colours Streamer material Bird scaring line aerial coverage length (m) Additional Comments BIRD SCARING LINE CODES/LIST OPTIONS: Position Design Towed Object Material Colour Port Side Single F = Inverted funnel/plastic cone T = Plastic tubing P = Pink Starboard Side Paired L = Length of thick line S = Plastic strapping R = Red Stern K = Knot or loop of thick line O = Other C = Carrot (Orange) B = Buoy Y = Yellow N = Netted buoy G = Green S = Sack or bag B = Blue W = Weight W = Brown Z = No towed object F = Faded colour (any colour) O = Other O = Other Summary of Inputted Values: Trip Number Distance between streamers Bird scaring line equipment code Streamer length (min) Bird scaring line position Streamer length (max) Backbone length Streamer colour Aerial coverage length Streamer material Attached height above water Number of streamers Bird scaring line material Towed object Bird scaring line design Additional comments M. External line weighting description form Bottom Long Line Weighting Form Single or Double line? Additional Comments: Average diameter of floats (m) Distance b/w sub-surface float and mainline (m) Number of hooks b/w surface float and anchor Average mass of weights (kg) Distance b/w line and weight Number of hooks b/w sub-surface floats Number of hooks b/w weights Summary of Inputted Values: Single or Double line? Number of hooks b/w surface float and anchor Avg mass of weights Number of hooks b/w sub-surface floats Distance b/w sub-surface float and mainline Number of hooks b/w weights Distance b/w line and weight Additional comments N. Bird baffler description form Bird Baffler - Top Down View Side Boom Connecting Curtain b/w Side and Aft Boom? PORT STARBOARD Boom length No. of streamers Height above water Streamer colour Streamer material Side Boom Distance from stern STERN Aft Boom Aft Boom Connecting Curtain b/w Aft Booms? Boom length No. of streamers Curtain length Height above water No. of streamers Streamer colour Curtain length Height above water Streamer material No. of streamers Streamer colour Height above water Streamer material Streamer colour Streamer material Summary of Inputted Values \u2014 Distance from stern Side Boom Aft Boom \u2014 Boom length \u2014 Boom length \u2014 Number of streamers \u2014 Number of streamers \u2014 Average distance between streamers \u2014 Average distance between streamers \u2014 Height above water \u2014 Height above water \u2014 Streamer colour \u2014 Streamer colour \u2014 Streamer material \u2014 Streamer material Side-Aft Curtain Aft Curtain \u2014 Curtain length \u2014 Curtain length \u2014 Number of streamers \u2014 Number of streamers \u2014 Average distance between streamers \u2014 Average distance between streamers \u2014 Height above water \u2014 Height above water \u2014 Streamer colour \u2014 Streamer colour \u2014 Streamer material \u2014 Streamer material O. Standard for observer data collected during a landing or while a vessel is in port With regards to fishing vessels flying their flag, and landing unprocessed (i.e. whole and no part of the fish having been removed) SPRFMO managed species, and where these landings are observed, Member States may collect and provide the following information: 1. The following vessel data for each observed landing: (a) Current vessel flag (b) Name of vessel (c) Fishing vessel registration number (d) IRCS (if any) (e) Lloyd's/IMO number (if allocated) (f) Type of vessel (use appropriate ISSCFV codes) (g) Type of fishing method(s) (use appropriate ISSCFG codes) 2. The following observer data for each observed landing: (a) Observer's name (b) Observer's organisation (c) Country of landing (standard ISO 3-alpha country codes) (d) Port/Point of landing 3. The following data for each observed landing: (a) Landing Date and time (UTC format) (b) First day of trip \u2013 to the extent practicable (c) Last day of trip \u2013 to the extent practicable (d) Indicative fishing area (decimal Lat/Long, 1 minute resolution \u2013 to the extent practicable) (e) Main target species (FAO species code) (f) Landed state by species (FAO species code) (g) Landed (live) weight by species (kilograms) for the landing event being observed In addition, the collection of Length-Frequency data, Biological data and/or Tag recovery data is to follow the standards described in Sections E, F and I respectively of this Annex for those species observed during landings or while a vessel is in port. Sections G (Incidental capture) and H (VMEs) are not considered relevant for observed landings. However, the standards described in Sections I (Tag recovery), J (Hierarchies) and K (Coding specifications) are still to be followed where applicable. ANNEX XI Port call request Vessel identification: Vessel name Vessel flag IMO number Call sign External identification Port call Details: Intended port of call (1) Port state Purpose (2) of port call Estimated arrival date Estimated arrival time Current date SPRFMO managed species held on-board: Species FAO area of capture Product state Total kilograms held on-board Amount to be transhipped/landed Recipient of transhipped/landed amount If no SPRFMO species or fish products originating from such species are held on board, then enter \u2018nil\u2019. Relevant fishing authorisation details: Identifier Issued by Validity Fishing area(s) Species Gear (3) Is a copy of the crew list attached? YES/NO (1) Should be a designated port as listed on the SPRFMO port register. (2) E.g. landing, transhipment, refueling. (3) If the authorisation is limited to transhipments then enter \u2018tranship\u2019 as the gear. ANNEX XII Port inspection summary results Inspection details: Inspection report number Principal inspector's name Port state Inspecting authority Port of inspection Purpose of call Inspection start date Inspection start time Inspection end date Inspection end time Prior notification received? Prior notification details consistent with inspection? Vessel details: Vessel name Vessel flag Vessel type IRCS External identification IMO number Vessel owner Vessel operator Vessel master (and nationality) Vessel agent VMS present? VMS type Relevant fishing authorisations: Authorisation identifier Issued by Validity Fishing areas Species Gear (1) Is the vessel in the SPRFMO record of vessels? Currently authorised? SPRFMO managed species off loaded (during this port call): Species FAO area of capture Product state Declared quantity off loaded Quantity off loaded SPRFMO managed species retained onboard: Species FAO area of capture Product state Declared quantity held on-board Quantity held on-board SPRFMO managed species received from transhipment (during this port call): Species FAO area of capture Product state Declared quantity received Quantity received Examinations and findings: Section Comments Examination of logbooks and other documentation Type of gear onboard Findings by inspectors Apparent infringements (include reference to relevant legal instruments) Vessel master's comments Actions taken Vessel master's signature Inspector's signature (1) If the authorisation is for transhipment then enter \u2018tranship\u2019 as the gear. ANNEX XIII List of other species of concern Scientific name English name 3-alpha code Carcharhinus longimanus Oceanic whitetip shark OCS Carcharodon carcharias Great white shark WSH Cetorhinus maximus Basking shark BSK Lamna nasus Porbeagle shark POR Manta spp. Manta rays MNT Mobula spp. Mobula nei RMV Rhincodon typus Whale shark RHN", "summary": "EU management measures for the South Pacific Regional Fisheries Management Organisation (SPRFMO) EU management measures for the South Pacific Regional Fisheries Management Organisation (SPRFMO) SUMMARY OF: Regulation (EU) 2018/975 \u2014 management, conservation and control measures applicable in the South Pacific Regional Fisheries Management Organisation (SPRFMO) Convention Area WHAT IS THE AIM OF THIS REGULATION? It aims to ensure that management, conservation and control rules of the convention area of the South Pacific Regional Fisheries Management Organisation (SPRFMO) are fully incorporated into EU law. The regulation works alongside the EU fisheries control system for the checking, inspection and enforcement by national authorities of the rules of the common fisheries policy. KEY POINTS SPRFMO SPRFMO is an inter-governmental organisation committed to the long-term conservation and sustainable use of the fishery resources of the South Pacific Ocean. The EU is a contracting party. Scope and application The regulation applies to: EU fishing vessels operating in the SPRFMO convention area;EU fishing vessels transshipping* fishery products caught in the SPRFMO convention area;non-EU country fishing vessels upon requesting access to, or being the object of an inspection in, EU ports and carrying fishery products harvested in the SPRFMO convention area. It applies without prejudice to: Regulation (EC) No 1005/2008 (see summary);Regulation (EC) No 1224/2009 (see summary);Regulation (EU) 2017/2403 (see summary). Rules requires EU countries to ensure a minimum 10% scientific observer coverage in the jack mackerel fishery and stop fishing when they have reached 100% of its catch limit; requires EU vessels to observe rules to protect seabirds including the use of bird scaring lines; to protect vulnerable marine ecosystems*, prohibits EU vessels from engaging in bottom fishing* or exploratory fishing* without authorisation from SPRFMO and on the basis of a bottom fishing assessment evaluated by the SPRFMO Scientific Committee; requires at least 10% of observer coverage for long-liners fishing for bottom fishing species and to cease from bottom fishing activities within 5 nautical miles of the area where any encounter with vulnerable marine ecosystems exceeds the threshold levels; bans the use of large scale pelagic drifting nets (gillnets or combinations of nets exceeding 2.5 kilometres in length), and all deepwater gillnets* throughout the SPRFMO convention area; requires the notification of transshipment of jack mackerel and demersal species and its monitoring when an observer is on board; requires EU vessels intending to transit the convention area while carrying gillnets to notify the SPRFMO Secretariat at least 36 hours before entering the area and to ensure that the vessels flying their flag operate a vessel monitoring system reporting once every 2 hours while in the SPRFMO convention area; requires EU countries to submit to the Commission, by 15 November each year, a list of fishing vessels flying their flag authorised to fish in the SPRFMO convention area for the following year, including the information contained in Annex V. The Commission forwards that list to the SPRFMO Secretariat; EU countries whose vessels fish in the SPRFMO must set up observer programmes to collect data on fish caught to be submitted to the Commission. FROM WHEN DOES THE REGULATION APPLY? It has applied since 19 July 2018. BACKGROUND The South Pacific Regional Fisheries Management Organisation (European Commission) KEY TERMS Transshipping: the transfer of a catch from a smaller fishing boat to a larger one, which then incorporates it into a larger batch for shipment. Vulnerable marine ecosystems: any marine ecosystem the integrity (i.e. ecosystem structure or function) of which is, according to the best scientific information available and to the precautionary principle, threatened by significant adverse impacts resulting from physical contact with bottom gears in the normal course of fishing operations, including reefs, seamounts, cold water corals or cold water sponge beds. Bottom fishing: fishing by any fishing vessel using any gear which is likely to come in contact with the seafloor or benthic organisms (i.e. those found in the ecological region at the lowest level of the ocean) during the normal course of operations. Exploratory fishing: fishing in an area that has not been subject to fishing or has not been subject to fishing with a particular gear type or technique in the previous 10 years. Deepwater gillnets: single or, less commonly, double- or triple-netting mounted together on the same frame ropes. Several types of nets may be combined in one gear. Those nets can be used either alone or, as is more usual, in large numbers placed in line (\u2018fleets\u2019 of nets). The gear can be set, anchored to the bottom or left drifting, free or connected with the vessel. MAIN DOCUMENT Regulation (EU) 2018/975 of the European Parliament and of the Council of 4 July 2018 laying down management, conservation and control measures applicable in the South Pacific Regional Fisheries Management Organisation (SPRFMO) Convention Area (OJ L 179, 16.7.2018, pp. 30-75) RELATED DOCUMENTS Regulation (EU) 2017/2403 of the European Parliament and of the Council of 12 December 2017 on the sustainable management of external fishing fleets, and repealing Council Regulation (EC) No 1006/2008 (OJ L 347, 28.12.2017, pp. 81-104) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, pp. 22-61) Successive amendments to Regulation (EU) No 1380/2013 have been incorporated into the original text. This consolidated version is of documentary value only. Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1-50) See consolidated version. Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, pp. 1-32) See consolidated version. last update 23.04.2020"}
{"article": "12.11.2018 EN Official Journal of the European Union L 284/6 REGULATION (EU) 2018/1672 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 October 2018 on controls on cash entering or leaving the Union and repealing Regulation (EC) No 1889/2005 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33 and 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The promotion of the harmonious, sustainable and inclusive development of the internal market as an area in which goods, persons, services and capital can freely and safely circulate is one of the priorities of the Union. (2) The reintroduction of illicit proceeds into the economy and the diversion of money to finance illicit activities create distortions and unfair competitive disadvantages for law-abiding citizens and companies, and are therefore a threat to the functioning of the internal market. Moreover, those practices foster criminal and terrorist activities which endanger the security of citizens of the Union. Accordingly, the Union has taken action to protect itself. (3) One of the main pillars of the action taken by the Union was Council Directive 91/308/EEC (3), which laid down a series of measures and obligations on financial institutions, legal persons and certain professions as regards, inter alia, transparency and record-keeping, as well as \u2018know-your-customer\u2019 provisions, and laid down an obligation to report suspicious transactions to national Financial Intelligence Units (FIUs). FIUs were established as hubs to assess such transactions, interact with their counterparts in other countries and, where required, contact judicial authorities. Directive 91/308/EEC has since been amended and replaced by successive measures. The provisions for the prevention of money laundering are currently laid down in Directive (EU) 2015/849 of the European Parliament and of the Council (4). (4) In light of the risk that the application of Directive 91/308/EEC would lead to an increase in cash movements for illicit purposes, which could pose a threat to the financial system and the internal market, that Directive was complemented by Regulation (EC) No 1889/2005 of the European Parliament and of the Council (5). That Regulation aims to prevent and detect money laundering and terrorist financing by laying down a system of controls applicable to natural persons who enter or leave the Union carrying amounts of cash or bearer-negotiable instruments equal to or greater than EUR 10 000 or its equivalent in other currencies. The term \u2018entering or leaving the Union\u2019 should be defined by reference to the territory of the Union as defined in Article 355 of the Treaty on the Functioning of the European Union (TFEU) in order to ensure that this Regulation has the broadest possible scope of application and that no areas would be exempt from its application and present opportunities to circumvent applicable controls. (5) Regulation (EC) No 1889/2005 implemented within the Community the international standards on combating money laundering and terrorist financing developed by the Financial Action Task Force (FATF). (6) The FATF, established at the G7 summit held in Paris in 1989, is an inter-governmental body that sets standards and promotes the effective implementation of legal, regulatory and operational measures to combat money laundering, terrorist financing and other related threats to the integrity of the international financial system. Several Member States are members of the FATF or are represented in the FATF through regional bodies. The Union is represented in the FATF by the Commission and has committed itself to the effective implementation of the FATF\u2019s recommendations. FATF Recommendation 32 on cash couriers specifies that measures should be in place with regard to adequate controls on cross-border movements of cash. (7) Directive (EU) 2015/849 identifies and describes a number of criminal activities the proceeds of which might be subject to money laundering or might be used for terrorist financing. The proceeds of those criminal activities are often transported across the external borders of the Union for the purpose of being laundered or used for terrorist financing. This Regulation should take that into account and lay down a system of rules that, in addition to contributing to the prevention of money laundering, and especially predicate offences such as tax crimes as defined in national law, and terrorist financing as such, facilitate the prevention, detection, and investigation of the criminal activities defined in Directive (EU) 2015/849. (8) Advances have been made regarding insights into the mechanisms used for transferring illicitly acquired value across borders. As a result, the FATF recommendations have been updated, Directive (EU) 2015/849 has introduced changes to the Union\u2019s legal framework and new best practices have been developed. In light of those developments and on the basis of the evaluation of existing Union legislation, Regulation (EC) No 1889/2005 needs to be amended. However, considering the extensive nature of the amendments that would be required, Regulation (EC) No 1889/2005 should be repealed and replaced with a new Regulation. (9) This Regulation does not affect the ability of Member States to provide, under their national law, for additional national controls on movements of cash within the Union, provided that those controls are in accordance with the Union\u2019s fundamental freedoms, in particular Articles 63 and 65 TFEU. (10) A set of rules at Union level which would allow comparable controls on cash within the Union would greatly facilitate efforts to prevent money laundering and terrorist financing. (11) This Regulation does not concern measures taken by the Union or Member States under Article 66 TFEU to restrict movements of capital that cause, or threaten to cause, serious difficulties for the operation of economic and monetary union or under Articles 143 and 144 TFEU as a result of a sudden crisis in the balance of payments. (12) Considering their presence at the external borders of the Union, their expertise in carrying out controls on passengers and freight crossing the external borders and their experience gained in the application of Regulation (EC) No 1889/2005, customs authorities should continue to act as the competent authorities for the purposes of this Regulation. At the same time, Member States should continue to be able also to designate other national authorities present at the external borders to act as competent authorities. Member States should continue to provide adequate training for the staff of customs authorities and other national authorities for the carrying out of those controls, including on cash-based money laundering. (13) One of the key concepts used in this Regulation is that of \u2018cash\u2019, which should be defined as comprising four categories: currency, bearer-negotiable instruments, commodities used as highly-liquid stores of value and certain types of prepaid cards. Given their characteristics, certain bearer-negotiable instruments, commodities used as highly-liquid stores of value, and prepaid cards which are not linked to a bank account and which can store an amount of money which is difficult to detect are likely to be used in place of currency as an anonymous means of transferring value across the external borders in a manner that is not traceable using the classic system of supervision by the public authorities. This Regulation should, therefore, lay down the essential components of the definition of \u2018cash\u2019, while at the same time enabling the Commission to amend the non-essential components of this Regulation in response to the attempts by criminals and their associates to circumvent a measure which controls only one type of highly-liquid store of value by bringing another type across the external borders. If evidence of such behaviour on a considerable scale is detected, it is essential that measures be taken swiftly to remedy the situation. Despite the high level of risk posed by virtual currencies, as evidenced in the Commission\u2019s report of 26 June 2017 on the assessment of the risks of money laundering and terrorist financing affecting the internal market and relating to cross-border activities, customs authorities do not have competence to monitor them. (14) Bearer-negotiable instruments enable the physical holder to claim a payment of a financial amount without being registered or mentioned by name. They can be easily used to transfer considerable amounts of value and present salient similarities with currency in terms of liquidity, anonymity and risks for abuse. (15) Commodities used as highly-liquid stores of value present a high ratio between their value and their volume, for which an easily accessible international trading market exists, allowing them to be converted into currency while incurring only modest transaction costs. Such commodities are mostly presented in a standardised way that allows for quick verification of their value. (16) Prepaid cards are non-nominal cards that store or provide access to a monetary value or funds which can be used for payment transactions, for acquiring goods or services or for redemption of currency. They are not linked to a bank account. Prepaid cards encompass anonymous prepaid cards as referred to in the Directive (EU) 2015/849. They are widely used for a variety of legitimate purposes and some of those instruments also present a clear social interest. Such prepaid cards are easily transferrable and can be used to transfer considerable value across the external borders. It is therefore necessary to include prepaid cards in the definition of cash, in particular if they can be bought without customer due diligence procedures. This will allow for the possibility to extend the controls to certain types of prepaid cards, taking into account the available technology, if justified by the evidence, provided that such controls are extended with due regard to proportionality and practical enforceability. (17) For the prevention of money laundering and terrorist financing, an obligation to declare cash should be imposed on natural persons entering or leaving the Union. In order not to restrict free movement unduly or overburden citizens and authorities with administrative formalities, the obligation should be subject to a threshold of EUR 10 000. It should apply to carriers carrying such amounts on their person, in their luggage or in the means of transport in which they cross the external borders. They should be required to make the cash available to the competent authorities for control and, if necessary, to present it to those authorities. The definition of \u2018carrier\u2019 should be understood as excluding those carriers who undertake the professional conveyance of goods or people. (18) As regards movements of unaccompanied cash, for example cash entering or leaving the Union in postal packages, courier shipments, unaccompanied luggage or containerised cargo, the competent authorities should have the power to require the sender or the recipient, or a representative thereof, to make a disclosure declaration, systematically or on a case-by-case basis, in accordance with national procedures. Such disclosure should cover a number of elements, which are not covered by the usual documentation submitted to customs, such as shipping documents and customs declarations. Such elements are the origin, destination, economic provenance and intended use of the cash. The obligation to disclose unaccompanied cash should be subject to a threshold identical to that for cash carried by carriers. (19) A number of standardised data elements regarding the movement of cash such as the personal details of the declarant, the owner or the recipient, the economic provenance and the intended use of the cash, should be recorded in order to achieve the objectives of this Regulation. In particular, it is necessary that the declarant, the owner or the recipient provide their personal details as contained in their identification documents, in order to reduce to a minimum the risk of errors regarding their identities and the delays due to the possible subsequent need for verification. (20) As regards the obligation to declare accompanied cash and the obligation to disclose unaccompanied cash, competent authorities should be empowered to carry out all requisite controls on persons, their luggage, the means of transport used to cross the external borders and any unaccompanied consignment or receptacle crossing that border which may contain cash, or a means of transport carrying them. In the event of failure to comply with those obligations, the competent authorities should compose an ex officio declaration for subsequent transmission of the relevant information to other authorities. (21) In order to ensure their uniform application by competent authorities, controls should be based primarily on a risk analysis, with the purpose of identifying and evaluating the risks and developing the necessary countermeasures. (22) The establishment of a common risk management framework should not prevent competent authorities from performing random checks or spontaneous controls whenever they deem necessary. (23) Where they detect amounts of cash below the threshold but there are indications that the cash might be linked to criminal activity as covered by this Regulation, the competent authorities should be able to record, in the case of accompanied cash, information about the carrier, the owner and, where available, the intended recipient of the cash, including full name, contact details, details concerning the nature and the amount or value of the cash, its economic provenance and intended use. (24) In the case of unaccompanied cash, competent authorities should be able to record information on the declarant, the owner, the sender, and the recipient or intended recipient of the cash, including full name, contact details, details concerning the nature and the amount or value of the cash, its economic provenance and intended use. (25) That information should be passed on to the FIU of the Member State in question, which should ensure that the FIU transmit any relevant information spontaneously or upon request to the FIUs of the other Member States. Those units are designated as the hub elements in the fight against money-laundering and terrorist financing who receive and process information from various sources such as financial institutions and analyse that information in order to determine if there are grounds for further investigation that may not be apparent to the competent authorities who collect the declarations and perform controls under this Regulation. To guarantee the effective flow of information, FIUs should all be connected to the Customs Information System (the \u2018CIS\u2019) established by Council Regulation (EC) No 515/97 (6) and the data produced or exchanged by competent authorities and FIUs should be compatible and comparable. (26) Recognising the importance for the successful follow-up of this Regulation of having an effective exchange of information between the relevant authorities, including FIUs within the legal framework covering those entities, and the need to strengthen the cooperation between FIUs within the Union, the Commission should assess by 1 June 2019 the possibility of establishing a common mechanism to fight money laundering and terrorist financing. (27) The detection of sub-threshold amounts of cash in situations where there are indications of criminal activity is highly relevant in this context. Consequently, it should also be possible to share information relating to sub-threshold amounts with the competent authorities in other Member States if there are indications of criminal activity. (28) Considering that the movements of cash that are subject to controls under this Regulation take place across the external borders, and given the difficulty of acting once the cash has left the point of entry or exit and the associated risk if even small amounts are used illicitly, the competent authorities should be able to detain cash temporarily in certain circumstances, subject to checks and balances: first, where the obligation to declare or to disclose cash has not been met and, second, where there are indications of criminal activity, irrespective of the amount or whether the cash is accompanied or unaccompanied. In view of the nature of such temporary detention and the impact that it might have on the freedom of movement and the right to property, the period of detention should be limited to the absolute minimum time that other competent authorities require to determine whether there are grounds for further intervention, such as investigations or seizure of the cash based on other legal instruments. A decision to detain cash temporarily under this Regulation should be accompanied by a statement of reasons and should adequately describe the specific factors that have given rise to the action. It should be possible to extend the period of temporary detention of the cash in specific and duly assessed cases, for instance when competent authorities encounter difficulties in obtaining information on a potential criminal activity, inter alia, when communication with a third country is required, when documents have to be translated or when it is difficult to identify and contact the sender or the recipient in the case of unaccompanied cash. If, at the end of the period of detention, no decision concerning further intervention is taken or if the competent authority decides that there are no grounds to further detain the cash, it should immediately be released, depending on the situation, to the person from whom the cash was temporarily detained, the carrier or the owner. (29) In order to raise awareness about this Regulation, Member States should, in cooperation with the Commission, develop appropriate materials regarding the obligation to declare or disclose cash. (30) It is essential that the competent authorities that collect information pursuant to this Regulation transmit it in a timely manner to the national FIU in order to enable it to further analyse and compare the information with other data as provided for in Directive (EU) 2015/849. (31) For the purpose of this Regulation, where the competent authorities register a failure to declare or disclose cash or where there are indications of criminal activity, they should promptly share that information with competent authorities of other Member States through appropriate channels. Such exchange of data would be proportionate considering that persons who have breached the obligation to declare or disclose cash and who have been apprehended in one Member State would be likely to select another Member State of entry or exit where the competent authorities would have no knowledge of their earlier breach. The exchange of such information should be mandatory in order to ensure that this Regulation is applied consistently across the Member States. Where there are indications that the cash is related to criminal activity which could adversely affect the financial interests of the Union, that information should also be made available to the Commission, to the European Public Prosecutor\u2019s Office as established by Council Regulation (EU) 2017/1939 (7) by the Member States participating in enhanced cooperation pursuant to that Regulation and to Europol as established by Regulation (EU) 2016/794 of the European Parliament and of the Council (8). In order to achieve the objectives of this Regulation of preventing and deterring the circumvention of the obligation to declare or disclose cash, anonymised risk information and risk analysis results should also mandatorily be exchanged between Member States and with the Commission, in accordance with standards to be set out in implementing acts adopted pursuant to this Regulation. (32) It should be possible to exchange information between a competent authority of a Member State or the Commission and the authorities of a third country provided that there are appropriate safeguards. Such exchange should only be permissible where relevant national and Union provisions on fundamental rights and the transfer of personal data are complied with, following authorisation by the authorities which originally obtained the information. The Commission should be informed of any occurrence of information exchange with third countries pursuant to this Regulation and should report thereon to the European Parliament and to the Council. (33) Given the nature of the information collected and the legitimate expectations of carriers and declarants that their personal data and information regarding the value of cash that they have brought into or taken out of the Union will be treated confidentially, the competent authorities should provide sufficient safeguards to ensure that agents who require access to the information respect professional secrecy, and adequately protect such information against unauthorised access, use or communication. Unless otherwise provided for by this Regulation or national law, particularly in the context of legal proceedings, such information should not be disclosed without the permission of the authority which obtained it. The processing of data under this Regulation may also cover personal data and should be carried out in accordance with Union law. Member States and the Commission should process personal data only in a manner compatible with the purposes of this Regulation. Any collection, disclosure, transmission, communication and other processing of personal data within the scope of this Regulation should be subject to the requirements of Regulations (EC) No 45/2001 (9) and (EU) 2016/679 (10) of the European Parliament and of the Council. The processing of personal data for the purposes of this Regulation should also respect the fundamental right to respect for private and family life recognised by Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms of the Council of Europe, as well as the right to respect for private and family life, and the right to the protection of personal data recognised, respectively, by Articles 7 and 8 of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019). (34) For the purposes of the analysis carried out by the FIUs and in order to enable authorities in other Member States to control and enforce the obligation to declare cash, particularly with respect to persons who have previously breached that obligation, it is necessary that the data contained in declarations made under this Regulation are stored for a sufficiently long period. In order for the FIU to effectively carry out their analysis and for the competent authorities to control and effectively enforce the obligation to declare or disclose cash, the period for the retention of data contained in declarations made under this Regulation should not exceed five years with a possible further extension, after a thorough assessment of the necessity and proportionality of such further retention, which should not exceed three additional years. (35) In order to encourage compliance and deter circumvention, Member States should introduce penalties for non-compliance with the obligations to declare or disclose cash. Those penalties should apply only to the failure to declare or disclose cash under this Regulation and should not take into account the potential criminal activity associated with the cash, which may be the object of further investigation and measures that fall outside the scope of this Regulation. Those penalties should be effective, proportionate and dissuasive, and should not go beyond what is required to encourage compliance. Penalties introduced by Member States should have an equivalent deterrent effect across the Union on the infringement of this Regulation. (36) While most Member States already use a harmonised declaration form, the EU Cash Declaration Form (EU-CDF), on a voluntary basis, in order to ensure the uniform application of controls and the efficient processing, transmission and analysis by competent authorities of the declarations, implementing powers should be conferred on the Commission to adopt the templates for the declaration form and the disclosure form, to determine the criteria for a common risk management framework, to establish the technical rules for the exchange of information and the template for the form to be used for the transmission of information, and to establish the rules and the format to be used for the provision of statistical information to the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11). (37) In order to improve the current situation in which there is limited access to statistical information and there are only some indications available on the extent of cash being smuggled across the Union\u2019s external borders by criminals, more effective cooperation via information exchange between competent authorities and with the Commission should be introduced. To guarantee that this exchange of information is effective and efficient, the Commission should review whether the system established fulfils the purpose or whether there are obstacles to the timely and direct exchange of information. Furthermore, the Commission should publish statistical information on its website. (38) In order to be able to quickly take account of future modifications of international standards such as standards established by the FATF or to address the circumvention of this Regulation through reliance on commodities used as highly-liquid stores of value or reliance on prepaid cards, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to Annex I to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (12). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States\u2019 experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (39) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of the transnational scale of money laundering and terrorist financing, and the specificities of the internal market and its fundamental freedoms, which can only be fully implemented by ensuring that no excessively disparate treatment based on national legislation is imposed on cash crossing the external borders of the Union, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives. (40) This Regulation respects the fundamental rights and observes the principles recognised in Article 6 TEU and reflected in the Charter, in particular Title II thereof. (41) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation provides for a system of controls with respect to cash entering or leaving the Union to complement the legal framework for the prevention of money laundering and terrorist financing laid down in Directive (EU) 2015/849. Article 2 Definitions 1. For the purposes of this Regulation, the following definitions apply: (a) \u2018cash\u2019 means: (i) currency; (ii) bearer-negotiable instruments; (iii) commodities used as highly-liquid stores of value; (iv) prepaid cards; (b) \u2018entering or leaving the Union\u2019 means coming from a territory which is outside the territory covered by Article 355 TFEU to the territory which is covered by that Article, or departing the territory covered by that Article; (c) \u2018currency\u2019 means banknotes and coins that are in circulation as a medium of exchange or that have been in circulation as a medium of exchange and can still be exchanged through financial institutions or central banks for banknotes and coins that are in circulation as a medium of exchange; (d) \u2018bearer-negotiable instruments\u2019 means instruments other than currency which entitle their holders to claim a financial amount upon presentation of the instruments without having to prove their identity or entitlement to that amount. Those instruments are: (i) traveller\u2019s cheques; and (ii) cheques, promissory notes or money orders that are either in bearer form, signed but with the payee\u2019s name omitted, endorsed without restriction, made out to a fictitious payee, or otherwise in such form that title thereto passes upon delivery; (e) \u2018commodity used as a highly-liquid store of value\u2019 means a good, as listed in point 1 of Annex I, that presents a high ratio between its value and its volume and that can easily be converted into currency through accessible trading markets while incurring only modest transaction costs; (f) \u2018prepaid card\u2019 means a non-nominal card, as listed in point 2 of Annex I, that stores or provides access to monetary value or funds which can be used for payment transactions, for acquiring goods or services or for the redemption of currency where such card is not linked to a bank account; (g) \u2018competent authorities\u2019 means the customs authorities of the Member States and any other authorities empowered by the Member States to apply this Regulation; (h) \u2018carrier\u2019 means any natural person entering or leaving the Union carrying cash on their person, in their luggage or in their means of transport; (i) \u2018unaccompanied cash\u2019 means cash making up part of a consignment without a carrier; (j) \u2018criminal activity\u2019 means any of the activities listed in point (4) of Article 3 of Directive (EU) 2015/849; (k) \u2018Financial Intelligence Unit (FIU)\u2019 means the entity established in a Member State for the purposes of implementing Article 32 of Directive (EU) 2015/849. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 of this Regulation in order to amend Annex I to this Regulation to take account of new trends in money laundering, as defined in Article 1(3) and (4) of Directive (EU) 2015/849, or terrorist financing, as defined in Article 1(5) of that Directive, or to take account of best practices in preventing money laundering or terrorist financing or to prevent the use by criminals of commodities used as highly-liquid stores of value and of prepaid cards to circumvent the obligations laid down in Articles 3 and 4 of this Regulation. Article 3 Obligation to declare accompanied cash 1. Carriers who carry cash of a value of EUR 10 000 or more shall declare that cash to the competent authorities of the Member State through which they are entering or leaving the Union and make it available to them for control. The obligation to declare cash shall not be deemed to be fulfilled if the information provided is incorrect or incomplete or if the cash is not made available for control. 2. The declaration referred to in paragraph 1 shall provide details about the following: (a) the carrier, including full name, contact details, including address, date and place of birth, nationality and identification document number; (b) the owner of the cash, including the full name, contact details, including address, date and place of birth, nationality and identification document number, where the owner is a natural person, or the full name, contact details, including address, registration number and, where available, value added tax (VAT) identification number, where the owner is a legal person; (c) where available, the intended recipient of the cash, including the full name, contact details, including address, date and place of birth, nationality and identification document number, where the intended recipient is a natural person, or the full name, contact details, including address, registration number and, where available, VAT identification number, where the intended recipient is a legal person; (d) the nature and the amount or value of the cash; (e) the economic provenance of the cash; (f) the intended use of the cash; (g) the transport route; and (h) the means of transport. 3. The details listed in paragraph 2 of this Article shall be provided in writing or electronically, using the declaration form referred to in to point (a) of Article 16(1). An endorsed copy of the declaration shall be delivered to the declarant upon request. Article 4 Obligation to disclose unaccompanied cash 1. Where unaccompanied cash of a value of EUR 10 000 or more is entering or leaving the Union, the competent authorities of the Member State through which the cash is entering or leaving the Union may require the sender or the recipient of the cash, or a representative thereof, as the case may be, to make a disclosure declaration within a deadline of 30 days. The competent authorities may detain the cash until the sender or the recipient, or a representative thereof, makes the disclosure declaration. The obligation to disclose unaccompanied cash shall not be deemed to be fulfilled where the declaration is not made before the deadline expires, the information provided is incorrect or incomplete, or the cash is not made available for control. 2. The disclosure declaration shall provide details about the following: (a) the declarant, including full name, contact details, including address, date and place of birth, nationality and identification document number; (b) the owner of the cash, including the full name, contact details, including address, date and place of birth, nationality and identification document number, where the owner is a natural person, or full name, contact details, including address, registration number and, where available, the VAT identification number, where the owner is a legal person; (c) the sender of the cash, including the full name, contact details, including address, date and place of birth, nationality and identification document number, where the sender is a natural person, or the full name, contact details, including address, registration number and where available, VAT identification number, where the sender is a legal person; (d) the recipient or intended recipient of the cash, including the full name, contact details, including address, date and place of birth, nationality and identification document number, where the recipient or intended recipient is a natural person, or the full name, contact details, including address, registration number and, where available, VAT identification number, where the recipient or intended recipient is a legal person; (e) the nature and the amount or value of the cash; (f) the economic provenance of the cash; and (g) the intended use of the cash. 3. The details listed in paragraph 2 of this Article shall be provided in writing or electronically, using the disclosure form referred to in point (a) of Article 16(1). An endorsed copy of the disclosure declaration shall be delivered to the declarant upon request. Article 5 Powers of the competent authorities 1. In order to verify compliance with the obligation to declare accompanied cash laid down in Article 3, the competent authorities shall have the power to carry out controls on natural persons, their luggage and their means of transport, in accordance with the conditions laid down in national law. 2. For the purposes of implementing the obligation to disclose unaccompanied cash laid down in Article 4, the competent authorities shall have the power to carry out controls on any consignments, receptacles or means of transport which may contain unaccompanied cash, in accordance with the conditions laid down in national law. 3. If the obligation to declare accompanied cash under Article 3 or the obligation to disclose unaccompanied cash under Article 4 has not been fulfilled, the competent authorities shall compose, in writing or in an electronic form, an ex officio declaration which shall contain to the extent possible the details listed in Article 3(2) or 4(2), as the case may be. 4. The controls shall be based primarily on risk analysis, with the purpose of identifying and evaluating the risks and developing the necessary countermeasures, and shall be performed within a common risk management framework in accordance with the criteria referred to in point (b) of Article 16(1) which shall also take into account the risk assessments established by the Commission and the FIUs under Directive (EU) 2015/849. 5. For the purposes of Article 6, the competent authorities shall also exercise the powers conferred on them under this Article. Article 6 Sub-threshold amounts suspected to be related to criminal activity 1. Where the competent authorities detect a carrier with an amount of cash below the threshold referred to in Article 3 and that there are indications that the cash is related to criminal activity, they shall record that information and the details listed in Article 3(2). 2. Where the competent authorities find that unaccompanied cash below the threshold referred to in Article 4 is entering or leaving the Union and that there are indications that the cash is related to criminal activity, they shall record that information and the details listed in Article 4(2). Article 7 Temporary detention of cash by competent authorities 1. The competent authorities may temporarily detain cash by means of an administrative decision in accordance with the conditions laid down in national law where: (a) the obligation to declare accompanied cash under Article 3 or the obligation to disclose unaccompanied cash under Article 4 has not been fulfilled; or (b) there are indications that the cash, irrespective of the amount, is related to criminal activity. 2. The administrative decision referred to in paragraph 1 shall be subject to an effective remedy in accordance with procedures provided for in national law. The competent authorities shall notify a statement of reasons for the administrative decision to: (a) the person required to make the declaration in accordance with Article 3 or the disclosure declaration in accordance with Article 4; or (b) the person required to provide the information in accordance with Article 6(1) or (2). 3. The period of temporary detention shall be strictly limited under national law to the time required for competent authorities to determine whether the circumstances of the case warrant further detention. The period of temporary detention shall not exceed 30 days. After the competent authorities carry out a thorough assessment of the necessity and proportionality of a further temporary detention, they may decide to extend the period of temporary detention to a maximum of 90 days. Where no determination is made regarding further detention of the cash within that period or if a determination is made that the circumstances of the case do not warrant further detention, the cash shall be immediately released to: (a) the person from whom the cash was temporarily detained in the situations referred to in Article 3 or 4; or (b) the person from whom the cash was temporarily detained in the situations referred to in Article 6(1) or (2). Article 8 Information campaigns Member States shall ensure that persons who enter or leave the Union or persons who send unaccompanied cash from the Union or who receive unaccompanied cash in the Union are informed of their rights and obligations under this Regulation and shall, in cooperation with the Commission, develop appropriate materials aimed at those persons. Member States shall ensure that sufficient funding is made available for such information campaigns. Article 9 Provision of information to the FIU 1. The competent authorities shall record the information obtained under Article 3 or 4, Article 5(3) or Article 6 and transmit it to the FIU of the Member State in which it was obtained, in accordance with the technical rules referred to in point (c) of Article 16(1). 2. The Member States shall ensure that the FIU of the Member State in question exchange such information with the relevant FIUs of the other Member States in accordance with Article 53(1) of Directive (EU) 2015/849. 3. The competent authorities shall transmit the information referred to in paragraph 1 as soon as possible, and in any event no later than 15 working days after the date on which the information was obtained. Article 10 Exchange of information between competent authorities and with the Commission 1. The competent authority of each Member State shall, by electronic means, transmit the following information to the competent authorities of all the other Member States: (a) ex officio declarations composed under Article 5(3); (b) information obtained under Article 6; (c) declarations obtained under Article 3 or 4, where there are indications that the cash is related to criminal activity; (d) anonymised risk information and risk analysis results. 2. Where there are indications that the cash is related to criminal activity which could adversely affect the financial interests of the Union, the information referred to in paragraph 1 shall also be transmitted to the Commission, to the European Public Prosecutor\u2019s Office by the Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939 and where it is competent to act under Article 22 of that Regulation, and to Europol where it is competent to act under Article 3 of Regulation (EU) 2016/794. 3. The competent authority shall transmit the information referred to in paragraphs 1 and 2 in accordance with the technical rules referred to in point (c) of Article 16(1) and using the form referred to in point (d) of Article 16(1). 4. The information referred to in points (a), (b), and (c) of paragraph 1 and in paragraph 2 shall be transmitted as soon as possible and in any event no later than 15 working days after the date on which that information was obtained. 5. The information and results referred to in point (d) of paragraph 1 shall be transmitted on a six-monthly basis. Article 11 Exchange of information with third countries 1. For the purpose of this Regulation, Member States or the Commission may, within the framework of mutual administrative assistance, transmit the following information to a third country, subject to the written authorisation of the competent authority which originally obtained the information, provided that such transmission complies with the relevant national and Union law on the transfer of personal data to third countries: (a) ex officio declarations composed under Article 5(3); (b) information obtained under Article 6; (c) declarations obtained under Article 3 or 4, where there are indications that the cash is related to money laundering or terrorist financing. 2. Member States shall notify the Commission of any transmission of information pursuant to paragraph 1. Article 12 Professional secrecy and confidentiality and data security 1. The competent authorities shall ensure the security of the data obtained in accordance with Articles 3 and 4, Article 5(3) and Article 6. 2. All information obtained by the competent authorities shall be covered by the duty of professional secrecy. Article 13 Personal data protection and retention periods 1. The competent authorities shall act as controllers of the personal data they obtain by operation of Articles 3 and 4, Article 5(3) and Article 6. 2. The processing of personal data on the basis of this Regulation shall take place only for the purposes of the prevention and fight against criminal activities. 3. The personal data obtained by operation of Articles 3 and 4, Article 5(3) and Article 6 shall be accessed only by duly authorised staff of the competent authorities and shall be adequately protected against unauthorised access or transmission. Unless otherwise provided for in Articles 9, 10 and 11, the data may not be disclosed or transmitted without the express authorisation of the competent authority which originally obtained them. However, that authorisation shall not be necessary where the competent authorities are required to disclose or transmit that data pursuant to the national law of the Member State in question, particularly in connection with legal proceedings. 4. The competent authorities and the FIU shall store personal data obtained by operation of Articles 3 and 4, Article 5(3) and Article 6 for a period of five years from the date on which the data were obtained. The personal data shall be erased upon the expiry of that period. 5. The period of retention may be extended once by another period which shall not exceed three additional years if: (a) after it has carried out a thorough assessment of the necessity and proportionality of such further retention and considers it to be justified for the fulfilment of its tasks with respect to the fight against money laundering or terrorist financing, the FIU determines that further retention is required; or (b) after they have carried out a thorough assessment of the necessity and proportionality of such further retention and consider it to be justified for the fulfilment of their tasks with respect to providing effective controls as regards the obligation to declare accompanied cash or the obligation to disclose unaccompanied cash, competent authorities determine that further retention is required. Article 14 Penalties Each Member State shall introduce penalties which shall apply in the event of failure to comply with the obligation to declare accompanied cash laid down in Article 3 or the obligation to disclose unaccompanied cash laid down in Article 4. Such penalties shall be effective, proportionate and dissuasive. Article 15 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 2(2) shall be conferred on the Commission for an indeterminate period of time from 2 December 2018. 3. The delegation of power referred to in Article 2(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 2(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 16 Implementing acts 1. The Commission shall adopt, by means of implementing acts, the following measures to ensure the uniform application of controls by competent authorities: (a) the templates for the declaration form referred to in Article 3(3) and for the disclosure form referred to in Article 4(3); (b) the criteria for the common risk management framework referred to in Article 5(4) and, more specifically, the risk criteria, standards, and priority control areas, based on the information exchanged pursuant to point (d) of Article 10(1), and Union and international policies and best practice; (c) the technical rules for the effective exchange of information under Article 9(1) and (3) and Article 10 of this Regulation via the CIS established by Article 23 of Regulation (EC) No 515/97; (d) the template for the form for the transmission of information referred to in Article 10(3); and (e) the rules and the format to be used by Member States for providing to the Commission with anonymised statistical information on declarations and infractions pursuant to Article 18. 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 17(2). Article 17 Committee procedure 1. The Commission shall be assisted by a Cash Controls Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 18 Transmission of information relating to the implementation of this Regulation 1. By 4 December 2021, Member States shall transmit the following to the Commission: (a) the list of competent authorities; (b) the details of the penalties introduced pursuant to Article 14; (c) anonymised statistical information regarding declarations, controls and infractions, using the format referred to in point (e) of Article 16(1). 2. Member States shall notify the Commission of any subsequent changes to the information referred to in points (a) and (b) of paragraph 1 at the latest one month after those changes take effect. The information referred to in point (c) of paragraph 1 shall be provided to the Commission at least every six months. 3. The Commission shall make the information referred to in point (a) of paragraph 1 and any subsequent changes to that information pursuant to paragraph 2 available to all the other Member States. 4. The Commission shall annually publish the information referred to in points (a) and (c) of paragraph 1 and any subsequent changes to that information pursuant to paragraph 2 on its website and shall inform users, in a clear way, about the controls with respect to cash entering or leaving the Union. Article 19 Evaluation 1. By 3 December 2021, and every five years thereafter, the Commission shall, on the basis of the information regularly received from the Member States, submit a report to the European Parliament and to the Council on the application of this Regulation. The report referred to in the first subparagraph shall, in particular, evaluate whether: (a) other assets should be included within the scope of this Regulation; (b) the disclosure procedure for unaccompanied cash is effective; (c) the threshold for unaccompanied cash should be reviewed; (d) the information flows in accordance with Articles 9 and 10 and the use of the CIS, in particular, are effective or whether there are obstacles to the timely and direct exchange of compatible and comparable information between competent authorities and with FIUs; and (e) the penalties introduced by Member States are effective, proportionate and dissuasive and in line with the established case-law of the Court of Justice of the European Union and whether they have an equivalent deterrent effect across the Union on the infringement of this Regulation. 2. The report referred to in paragraph 1 shall include, where available: (a) a compilation of information received from Member States regarding cash related to criminal activities which adversely affect the financial interests of the Union; and (b) information on exchange of information with third countries. Article 20 Repeal of Regulation (EC) No 1889/2005 Regulation (EC) No 1889/2005 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 21 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 3 June 2021. However, Article 16 shall apply from 2 December 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 23 October 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) OJ C 246, 28.7.2017, p. 22. (2) Position of the European Parliament of 12 September 2018 (not yet published in the Official Journal) and Decision of the Council of 9 October 2018. (3) Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (OJ L 166, 28.6.1991, p. 77). (4) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73). (5) Regulation (EC) No 1889/2005 of the European Parliament and of the Council of 26 October 2005 on controls of cash entering or leaving the Community (OJ L 309, 25.11.2005, p. 9). (6) Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters (OJ L 82, 22.3.1997, p. 1). (7) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor\u2019s Office (\u2018the EPPO\u2019) (OJ L 283, 31.10.2017, p. 1). (8) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53). (9) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (10) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (11) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (12) OJ L 123, 12.5.2016, p. 1. ANNEX I Commodities used as highly-liquid stores of value and prepaid cards which are considered cash in accordance with point (a)(iii) and (iv) of Article 2(1) 1. Commodities used as highly-liquid stores of value: (a) coins with a gold content of at least 90 %; and (b) bullion such as bars, nuggets or clumps with a gold content of at least 99,5 %. 2. Prepaid cards: P.M. ANNEX II CORRELATION TABLE Regulation (EC) No 1889/2005 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 Article 3 \u2014 Article 4 Article 4(1) Article 5 Article 5(2) Article 6 Article 4(2) Article 7 \u2014 Article 8 Article 5(1) Article 9 Article 6 Article 10 Article 7 Article 11 Article 8 Article 12 \u2014 Article 13 Article 9 Article 14 \u2014 Article 15 \u2014 Article 16 \u2014 Article 17 \u2014 Article 18 Article 10 Article 19 \u2014 Article 20 Article 11 Article 21 \u2014 Annex I \u2014 Annex II", "summary": "Controls on cash entering or leaving the EU Controls on cash entering or leaving the EU SUMMARY OF: Regulation (EU) 2018/1672 on controls on cash entering or leaving the EU WHAT IS THE AIM OF THE REGULATION? The regulation introduces controls on cash* entering or leaving the EU. These are designed to support the measures set out in Directive (EU) 2015/849 against money laundering and terrorist financing. KEY POINTS Anyone entering or leaving the EU with \u20ac10.000 or more must declare the cash to that country\u2019s authorities and provide the following information, either in writing or electronically: full personal details, such as name, nationality and date of birth, of the carrier*, the owner and the intended recipient of the cash; value and nature of the cash, its origin, its intended use and the method of transport. EU countries\u2019 authorities may: ask the sender or recipient of any unaccompanied cash of \u20ac10.000 or more to declare it within 30 days by providing the same information as above; search people, their luggage and form of transport and any consignments or packages in which cash may be sent; record the details of any sums of cash below \u20ac10.000 if they suspect it is related to criminal activity; detain cash that is not declared or is linked to crime; share information with a non-EU country subject to specific procedures. EU countries\u2019 authorities must: transmit any relevant information to the national financial intelligence unit concerned as soon as possible and no later than 15 days; transmit any relevant information to the competent authorities of other EU countries; inform the European Commission, the European Public Prosecutor\u2019s Office and, if necessary, Europol if the cash is linked to crime involving the EU budget; ensure the security of all data they obtain and store them under strict conditions. EU governments must: ensure that people entering or leaving the EU, or senders and recipients of the sums involved, are informed of their rights and obligations; introduce penalties for any violation of the legislation; inform the Commission by 4 December 2021 of the measures they have taken to implement the legislation. The Commission: adopts additional technical measures such as templates for declarations forms and rules for information exchange by means of implementing acts; is assisted by a cash controls committee; must submit a report to the European Parliament and to the Council on the impact of the legislation. Repeal Regulation (EU) 2018/1672 repeals and replaces Regulation (EC) No 1889/2005 from 2 June 2021. FROM WHEN DOES THE REGULATION APPLY? It applies from 3 June 2021, apart from the rules regarding the Commission\u2019s work on technical measures, which have applied since 2 December 2018. BACKGROUND The legislation is part of EU measures to tackle terrorist financing, money laundering, tax evasion and other criminal activities. It extends the previous legal definition of \u2018cash\u2019 from banknotes to include cheques, traveller\u2019s cheques, prepaid cards and gold. KEY TERMS Cash: banknotes and coins, cheques, traveller\u2019s cheques, prepaid cards, gold bullion. Carrier: an individual entering or leaving the EU carrying cash on their person, in their luggage or in their form of transport. MAIN DOCUMENT Regulation (EU) 2018/1672 of the European Parliament and of the Council of 23 October 2018 on controls on cash entering or leaving the Union and repealing Regulation (EC) No 1889/2005 (OJ L 284, 12.11.2018, pp. 6-21) RELATED DOCUMENTS Directive (EU) 2018/1673 of the European Parliament and of the Council of 23 October 2018 on combating money laundering by criminal law (OJ L 284, 12.11.2018, pp. 22-30) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, pp. 73-117) Successive amendments to Directive (EU) 2015/849 have been incorporated into the original document. This consolidated version is of documentary value only. last update 13.02.2019"}
{"article": "21.12.2018 EN Official Journal of the European Union L 328/1 REGULATION (EU) 2018/1999 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) and Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) This Regulation sets out the necessary legislative foundation for reliable, inclusive, cost-efficient, transparent and predictable governance of the Energy Union and Climate Action (governance mechanism), which ensures the achievement of the 2030 and long-term objectives and targets of the Energy Union in line with the 2015 Paris Agreement on climate change following the 21st Conference of the Parties to the United Nations Framework Convention on Climate Change (the \u2018Paris Agreement\u2019), through complementary, coherent and ambitious efforts by the Union and its Member States, while limiting administrative complexity. (2) The Energy Union should cover five dimensions: energy security; the internal energy market; energy efficiency; decarbonisation; and research, innovation and competitiveness. (3) The goal of a resilient Energy Union with an ambitious climate policy at its core is to give Union consumers, including households and businesses, secure, sustainable, competitive and affordable energy, and to foster research and innovation by means of attracting investment, which requires a fundamental transformation of Europe's energy system. Such a transformation is also closely linked to the need to preserve, protect and improve the quality of the environment and to promote the prudent and rational utilisation of natural resources, in particular through the promotion of energy efficiency and energy savings and the development of new and renewable forms of energy. That goal can be achieved only through coordinated action, combining both legislative and non-legislative acts at Union, regional, national and local level. (4) A fully functional and resilient Energy Union would convert the Union into a leading region for innovation, investment, growth and social and economic development, in turn providing a good example of how pursuing high ambitions in terms of climate change mitigation is intertwined with measures to foster innovation, investment and growth. (5) Parallel to this Regulation, the Commission has developed and adopted a series of initiatives in sectoral energy policy, in particular with regard to renewable energy, energy efficiency, including on the energy performance of buildings, and market design. Those initiatives form a package under the overarching theme of energy efficiency first, the Union's global leadership in renewables, and a fair deal for energy consumers, including by addressing energy poverty and promoting fair competition in the internal market. (6) In its conclusions of 23 and 24 October 2014, the European Council endorsed a 2030 Framework for Energy and Climate for the Union based on four key Union-level targets: a reduction of at least 40 % in economy-wide greenhouse gas (GHG) emissions, an indicative target of improvement in energy efficiency of at least 27 %, to be reviewed by 2020 with a view to increasing the level to 30 %, a share of renewable energy consumed in the Union of at least 27 %, and electricity interconnection of at least 15 %. It specified that the target for renewable energy is binding at Union level and that it will be fulfilled through Member States' contributions guided by the need to deliver collectively the Union target. A recast of Directive 2009/28/EC of the European Parliament and of the Council (4) has introduced a new, binding, renewable energy target for the Union for 2030 of at least 32 %, including a provision for a review with a view to increasing the Union-level target by 2023. Amendments to Directive 2012/27/EU of the European Parliament and of the Council (5) have set the Union-level target for improvements in energy efficiency in 2030 to at least 32,5 %, including a provision for a review with a view to increasing the Union-level targets. (7) The binding target of at least a 40 % domestic reduction in economy-wide GHG emissions by 2030 compared to 1990 was formally approved as the Intended Nationally Determined Contribution of the Union and its Member States to the Paris Agreement at the Environment Council meeting on 6 March 2015. The Paris Agreement was ratified by the Union on 5 October 2016 (6) and entered into force on 4 November 2016. It replaces the approach taken under the 1997 Kyoto Protocol, which was approved by the Union by Council Decision 2002/358/EC (7) and which will not be continued beyond 2020. The Union's system for monitoring and reporting emissions and removals should be updated accordingly. (8) The Paris Agreement increased the level of global ambition on climate change mitigation and sets out a long-term goal in line with the objective to keep the global average temperature increase to well below 2 \u00b0C above pre-industrial levels and to pursue efforts to limit the temperature increase to 1,5 \u00b0C above pre-industrial levels. (9) In pursuit of the temperature goals in the Paris Agreement, the Union should aim to achieve a balance between anthropogenic GHG emissions by sources and removals by sinks as early as possible and, as appropriate, achieve negative emissions thereafter. (10) For the climate system the cumulative total anthropogenic emissions over time are relevant for the total concentration of GHGs in the atmosphere. Various scenarios for the Union's contribution to long-term objectives, inter alia a scenario on achieving net zero GHG emissions in the Union by 2050 and negative emissions thereafter, and the implications of those scenarios on the remaining global and Union carbon budget should be analysed by the Commission. The Commission should prepare an analysis for the purposes of a long-term Union strategy for the Union's contribution to the commitments of the Paris Agreement of holding the increase in the global average temperature to well below 2 \u00b0C above pre-industrial levels and to pursue efforts to limit the temperature increase to 1,5 \u00b0C above pre-industrial levels, including various scenarios, inter alia a scenario on achieving net zero GHG emissions within the Union by 2050 and negative emissions thereafter and their implications on the global and Union carbon budget. (11) Although the Union pledged to deliver ambitious cuts in GHG emissions by 2030, the threat of climate change is a global issue. The Union and its Member States should therefore work with their international partners in order to ensure a high level of ambition by all Parties in line with the long-term goals of the Paris Agreement. (12) In its conclusions of 23 and 24 October 2014, the European Council also agreed that a reliable and transparent governance mechanism without any unnecessary administrative burden and with sufficient flexibility for Member States should be developed to help ensure that the Union meets its energy policy goals, while fully respecting Member States' freedom to determine their energy mix. It emphasised that such a governance mechanism should build on existing building blocks, such as national climate programmes, national plans for renewable energy and energy efficiency as well as the need to streamline and bring together separate planning and reporting strands. It also agreed to step up the role and rights of consumers, transparency and predictability for investors, inter alia by systematic monitoring of key indicators for an affordable, safe, competitive, secure and sustainable energy system and to facilitate coordination of national climate and energy policies and foster regional cooperation between Member States. (13) In its communication of 25 February 2015 on A Framework Strategy for a Resilient Energy Union with a Forward-Looking Climate Change Policy, the Commission refers to the need for an integrated governance mechanism to ensure that energy-related actions at Union, regional, national and local level all contribute to the Energy Union's objectives, thereby broadening the scope of governance \u2014 beyond the 2030 Framework for Climate and Energy \u2014 to all five dimensions of the Energy Union. (14) In its communication of 18 November 2015 on the State of the Energy Union, the Commission further specified that integrated national energy and climate plans, addressing all five dimensions of the Energy Union, are necessary tools for a more strategic energy and climate policy planning. As part of that communication, the Commission Guidance to Member States on integrated national energy and climate plans provided the basis for Member States to start developing national plans for the period 2021 to 2030 and set out the main pillars of the governance mechanism. The communication also specified that such governance should be anchored in law. (15) In its conclusions of 26 November 2015 on the governance system of the Energy Union, the Council recognised that governance of the Energy Union will be an essential tool for the efficient and effective construction of the Energy Union and the achievement of its objectives. The Council underlined that the governance mechanism should be based on the principles of integration of strategic planning and reporting on the implementation of climate and energy policies and coordination between actors responsible for energy and climate policy, at Union, regional and national level. It also underlined that the governance mechanism should ensure that the agreed energy and climate targets for 2030 are met and should monitor the Union's collective progress towards the achievement of the policy objectives across the five dimensions of the Energy Union. (16) The European Parliament's resolution of 15 December 2015 entitled \u2018Towards a European Energy Union\u2019 called for the governance mechanism of the Energy Union to be ambitious, reliable, transparent, democratic and fully inclusive of the European Parliament and to ensure that the 2030 climate and energy targets are achieved. (17) The European Council has repeatedly stressed the need to take urgent measures in order to ensure the achievement of a minimum target of 10 % of electricity interconnections. In its conclusions of 23 and 24 October 2014, the European Council decided that the Commission supported by the Member States will take urgent measures in order to ensure the achievement of a minimum target of 10 % of electricity interconnections, as a matter of urgency, and no later than 2020 at least for Member States which have not yet attained a minimum level of integration in the internal energy market. The communication of the Commission of 23 November 2017 on strengthening Europe's energy networks assesses progress towards achieving the 10 % interconnection target and suggests ways in which to operationalise the 15 % interconnection target for 2030. (18) The main objective of the governance mechanism should therefore be to enable the achievement of the objectives of the Energy Union and in particular the targets of the 2030 Framework for Climate and Energy, in the field of GHG emission reduction, energy from renewable sources and energy efficiency. Those objectives and targets stem from the Union policy on energy and from the need to preserve, protect and improve the quality of the environment and to promote the prudent and rational utilisation of natural resources, as provided for in the EU Treaties. None of those objectives, which are indissociably linked, can be regarded as secondary to the other. This Regulation is therefore linked to sectoral law implementing the 2030 targets for energy and climate. While Member States need flexibility to choose policies that are best-matched to their national energy mix and preferences, that flexibility should be compatible with further market integration, increased competition, the attainment of climate and energy objectives and the gradual shift towards a sustainable low-carbon economy. (19) A socially acceptable and just transition to a sustainable low-carbon economy requires changes in investment behaviour, as regards both public and private investment, and incentives across the entire policy spectrum, taking into consideration citizens on whom and regions on which the transition to a low-carbon economy could have adverse impacts. Achieving GHG emission reductions requires a boost to efficiency and innovation in the European economy and in particular should also create sustainable jobs, including in high-tech sectors, and lead to improvements of air quality and public health. (20) In view of the international commitments in the Paris Agreement, Member States should report on actions that they undertake to phase out energy subsidies, in particular for fossil fuels. When reporting, Member States may choose to base themselves on existing definitions for fossil fuel subsidies used internationally. (21) As GHGs and air pollutants largely derive from common sources, policy designed to reduce GHGs can have co-benefits for public health and air quality, in particular in urban areas, that could offset the near-term costs of GHG mitigation. As data reported under Directive (EU) 2016/2284 of the European Parliament and of the Council (8) represent an important input for the compilation of the GHG inventory and the national plans, the importance of compilation and reporting of consistent data between Directive (EU) 2016/2284 and the GHG inventory should be recognised. (22) The experience gained in implementing Regulation (EU) No 525/2013 of the European Parliament and the Council (9) indicated the need for synergies and coherence with reporting under other legal instruments, in particular with Directive 2003/87/EC of the European Parliament and of the Council (10), Regulation (EC) No 166/2006 of the European Parliament and of the Council (11), Regulation (EC) No 1099/2008 of the European Parliament and of the Council (12) and Regulation (EC) No 517/2014 of the European Parliament and of the Council (13). The use of consistent data to report GHG emissions is essential to ensuring the quality of emissions reporting. (23) In line with the Commission's strong commitment to better regulation and consistent with a policy that promotes research, innovation and investment, the governance mechanism should result in a significant reduction of administrative burden and complexity for the Member States and relevant stakeholders, the Commission and other Union institutions. It should also help to ensure coherence and adequacy of policies and measures at Union and national level with regard to the transformation of the energy system towards a sustainable low-carbon economy. (24) The achievement of the Energy Union objectives and targets should be ensured through a combination of Union initiatives and coherent national policies set out in integrated national energy and climate plans. Sectoral Union law in the energy and climate fields sets out planning requirements, which have been useful tools to drive change at the national level. Their introduction at different times has led to overlaps and insufficient consideration of synergies and interactions between policy areas, to the detriment of cost-efficiency. Current separate planning, reporting and monitoring in the climate and energy fields should therefore as far as possible be streamlined and integrated. (25) The integrated national energy and climate plans should cover ten-year periods and should provide an overview of the current energy system and policy situation. They should set out national objectives for each of the five dimensions of the Energy Union and corresponding policies and measures to meet those objectives and have an analytical basis. The integrated national energy and climate plans covering the first period from 2021 to 2030 should pay particular attention to the 2030 targets for GHG emission reductions, renewable energy, energy efficiency and electricity interconnection. Member States should aim to ensure that the integrated national energy and climate plans are consistent with, and contribute to, achieving the United Nations Sustainable Development Goals. In their integrated national energy and climate plans, Member States may build upon existing national strategies or plans. For the first draft and final integrated national energy and climate plan, a different deadline is provided as compared to subsequent plans, in order to provide Member States with adequate preparation time for their first plans after the adoption of this Regulation. Nevertheless, Member States are encouraged to provide their first draft integrated national energy and climate plans as early as possible in 2018, in order to allow proper preparation, in particular for the facilitative dialogue to be convened in 2018 in accordance with Decision 1/CP.21 of the Conference of the Parties to the United Nations Framework Convention on Climate Change (UNFCCC). (26) In their integrated national energy and climate plans, Member States should assess the number of households in energy poverty, taking into account the necessary domestic energy services needed to guarantee basic standards of living in the relevant national context, existing social policy and other relevant policies, as well as Commission indicative guidance on relevant indicators, including geographical dispersion, that are based on a common approach for energy poverty. In the event that a Member State finds that it has a significant number of households in energy poverty, it should include in its plan a national indicative objective to reduce energy poverty. (27) A mandatory template for the integrated national energy and climate plans should be established to ensure that all national plans are sufficiently comprehensive and to facilitate comparison and aggregation of national plans, while at the same time ensuring sufficient flexibility for Member States to set out the details of national plans reflecting national preferences and specificities. (28) The implementation of policies and measures in the areas of energy and climate has an impact on the environment. Member States should therefore ensure that the public is given early and effective opportunities to participate in and to be consulted on the preparation of the integrated national energy and climate plans in accordance, where applicable, with the provisions of Directive 2001/42/EC of the European Parliament and of the Council (14) and the United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters of 25 June 1998 (the \u2018Aarhus convention\u2019). Member States should also ensure involvement of social partners in the preparation of the integrated national energy and climate plans, and aim to limit administrative complexity when fulfilling their obligations with regard to public consultation. (29) When carrying out public consultations, and in line with the Aarhus Convention, Member States should aim to ensure equal participation, that the public is informed by public notices or other appropriate means such as electronic media, that the public is able to access all relevant documents, and that practical arrangements related to the public's participation are put in place. (30) Each Member State should establish a permanent multi-level energy dialogue, bringing together local authorities, civil society organisations, the business community, investors and other relevant stakeholders to discuss the different options envisaged for energy and climate policies. It should be possible for the Member State's integrated national energy and climate plan as well as its long-term strategy to be discussed within the framework of that dialogue. The dialogue may take place by means of any national structure, such as a website, public consultation platform or another interactive communication tool. (31) Regional cooperation is key to ensuring the effective achievement of the objectives of the Energy Union in a cost-optimal manner. The Commission should facilitate such cooperation between the Member States. Member States should get the opportunity to comment on other Member States' integrated national energy and climate plans before they are finalised to avoid inconsistencies and potential negative impacts on other Member States and ensure that common objectives are met collectively. Regional cooperation in elaborating and finalising integrated national energy and climate plans as well as in their subsequent implementation should be essential to improving the effectiveness and efficiency of measures and fostering market integration and energy security. (32) Where they cooperate in the framework of this Regulation, Member States should take into consideration existing regional cooperation fora, such as the Baltic Energy Market Interconnection Plan (BEMIP), Central and South-Eastern Europe Connectivity (CESEC), Central-West Regional Energy Market (CWREM), the North Seas Countries' Offshore Grid Initiative (NSCOGI), the Pentalateral Energy Forum, Interconnections for South-West Europe and the Euro-Mediterranean Partnership. Member States are encouraged to envisage cooperation with signatories to the Energy Community, third-country members of the European Economic Area and, where appropriate, with other relevant third countries. Moreover, the Commission may, with a view to promoting market integration, cost-efficient policies, effective cooperation, partnerships and consultations, identify further opportunities for regional cooperation covering one or more of the five dimensions of the Energy Union in accordance with this Regulation, with a long-term vision and based on existing market conditions. (33) The Commission may undertake discussions with relevant third countries in order to explore the possibility to extend towards them the application of provisions established under this Regulation, in particular those related to regional cooperation. (34) Integrated national energy and climate plans should be stable to ensure the transparency and predictability of national policies and measures in order to ensure investment certainty. National plans should however be updated once during the ten-year period covered to give Member States the opportunity to adapt to significant changing circumstances. For the plans covering the period 2021 to 2030, Member States should update their plans by 30 June 2024. Objectives, targets and contributions should only be modified to reflect an increased overall ambition in particular as regards the 2030 targets for energy and climate. As part of the updates, Member States should make efforts to mitigate any adverse environmental impacts that become apparent as part of the integrated reporting. (35) Stable long-term strategies are crucial to contribute towards economic transformation, jobs, growth and the achievement of broader sustainable development goals, as well as to move in a fair and cost-effective manner towards the long-term goal set by the Paris Agreement. Furthermore, Parties to the Paris Agreement are invited to communicate, by 2020, their mid-century, long-term low GHG emission development strategies. In that context, the European Council invited the Commission on 22 March 2018 to present, by the first quarter of 2019, a proposal for a strategy for long-term Union GHG emission reductions in accordance with the Paris Agreement, taking into account the integrated national energy and climate plans. (36) Member States should develop long-term strategies with a perspective of at least 30 years contributing to the fulfilments of the Member States' commitments under the UNFCCC and the Paris Agreement, in the context of the objective of the Paris Agreement of holding the increase in the global average temperature to well below 2 \u00b0C above pre-industrial levels and to pursue efforts to limit the temperature increase to 1,5 \u00b0C above pre-industrial levels and achievement of long-term GHG emission reductions and enhancements of removals by sinks in all sectors in line with the Union's objective. Member States should develop their strategies in an open and transparent manner and should ensure effective opportunities for the public to participate in their preparation. Their integrated national energy and climate plans and the long-term strategies should be consistent with each other. (37) The land use, land use change and forestry (LULUCF) sector is highly exposed and very vulnerable to climate change. At the same time, the sector has huge potential to provide for long-term climate benefits and to contribute significantly to the achievement of Union and international long-term climate goals. It can contribute to climate change mitigation in several ways, in particular by reducing emissions, maintaining and enhancing sinks and carbon stocks, and providing bio-materials that can substitute fossil or carbon-intensive materials. Long-term strategies underpinning sustainable investment aiming to increase effective carbon sequestration, sustainable resource management, and long-term stability and adaptability of carbon pools, are essential. (38) When developing further interconnections, it is important to make a complete assessment of the costs and benefits, including the full technical, socio-economic and environmental impacts thereof as required by Regulation (EU) No 347/2013 of the European Parliament and of the Council (15) and take into account the positive externalities of interconnections, such as the integration of renewables, security of supply and increased competition in the internal market. (39) As is the case for planning, sectoral Union law in the energy and climate fields sets out reporting requirements, many of which have been useful tools to drive change at the national level, complementary to market reforms, but those requirements have been introduced at different times, leading to overlaps and cost-inefficiency, as well as insufficient consideration of synergies and interactions between policy areas such as GHG mitigation, renewable energy, energy efficiency and market integration. To strike the right balance between the need to ensure a proper follow-up of the implementation of the integrated national energy and climate plans and the need to reduce administrative complexity, Member States should establish biennial progress reports on the implementation of the plans and other developments in the energy system. Some reporting however, particularly with regard to reporting requirements in the climate field stemming from the UNFCCC and Union law, would still be necessary on an annual basis. (40) Member States' integrated national energy and climate progress reports should mirror the elements set out in the template for the integrated national energy and climate plans. A template for the integrated national energy and climate progress reports should be detailed in subsequent implementing acts given their technical nature and the fact that the first progress reports are due in 2023. The progress reports should be carried out in order to ensure transparency towards the Union, other Member States, regional and local authorities, market actors including consumers, any other relevant stakeholders and the general public. They should be comprehensive across the five dimensions of the Energy Union and, for the first period, at the same time put emphasis on areas covered by the targets of the 2030 Climate and Energy Framework. (41) Under the UNFCCC, the Union and its Member States are required to develop, regularly update, publish and report to the Conference of the Parties national inventories of anthropogenic emissions by sources and removals by sinks of all GHGs using comparable methodologies agreed by the Conference of the Parties. The GHG inventories are key to enabling the tracking of progress with the implementation of the decarbonisation dimension and for assessing compliance with the legislative acts in the field of climate, in particular Regulation (EU) 2018/842 of the European Parliament and of the Council (16) and Regulation (EU) 2018/841 of the European Parliament and of the Council (17). (42) Decision 1/CP.16 of the Conference of the Parties to the UNFCCC requires the establishment of national arrangements to estimate anthropogenic emissions by sources and removals by sinks of all GHGs. This Regulation should enable the establishment of those national arrangements. (43) Experience in the implementation of Regulation (EU) No 525/2013 has demonstrated the importance of transparency, accuracy, consistency, completeness and comparability of information. Building on that experience, this Regulation should ensure that Member States use robust and consistent data and assumptions across the five dimensions and make publicly available comprehensive information concerning the assumptions, parameters and methodologies used for the final scenarios and projections taking into account statistical restrictions, commercially sensitive data, and compliance with the data protection rules, and report on their policies and measures, and projections as a key component of the progress reports. The information in those reports should be essential for demonstrating the timely implementation of commitments under Regulation (EU) 2018/842. Operating and continuously improving systems at Union and Member State level coupled with better guidance on reporting should significantly contribute towards an ongoing strengthening of the information necessary in order to track progress in the decarbonisation dimension. (44) This Regulation should ensure reporting by Member States on adaptation to climate change and the provision of financial, technological and capacity-building support to developing countries, thereby facilitating the implementation of the Union's commitments under the UNFCCC and Paris Agreement. Furthermore, information on national adaptation actions and support is also important in the context of the integrated national energy and climate plans, especially as regards adaptation to those adverse effects of climate change related to the security of the Union's energy supply such as the availability of cooling water for power plants and biomass availability for energy, and information on support relevant to the external dimension of the Energy Union. (45) The Paris Agreement reaffirms that the Parties should, when taking action to address climate change, respect, promote and consider their respective obligations on human rights and gender equality. Member States should therefore adequately integrate the dimensions of human rights and gender equality in their integrated national energy and climate plans and long-term strategies. Through their biennial progress reports they should report information on how the implementation of their integrated national energy and climate plans contributes to the promotion of both human rights and gender equality. (46) In order to limit administrative burden on Member States and the Commission, the latter should establish an online platform (e-platform) to facilitate communication, promote cooperation and facilitate public access to information. That should facilitate timely submission of reports as well as improved transparency on national reporting. The e-platform should complement, build on and benefit from existing reporting processes, databases and e-tools, such as those of the European Environment Agency, Eurostat, the Joint Research Centre and the experience gained from the Union's Eco-Management and Audit Scheme. (47) The Commission should ensure that the final integrated national energy and climate plans are publicly available online. The e-platform, once operational, should be used by the Commission to host and make publicly available the final integrated national energy and climate plans, the updates thereof, the long-term strategies and other relevant reporting information provided by Member States. Before the e-platform becomes operational, the Commission will use its own websites to facilitate public online access to the final integrated national energy and climate plans. (48) As concerns data to be provided to the Commission by means of national planning and reporting, information from Member States should not duplicate data and statistics which have already been made available via Eurostat in the context of Regulation (EC) No 223/2009 of the European Parliament and of the Council (18) in the same form as under the planning and reporting obligations laid down in this Regulation and are still available from the Commission (Eurostat) with the same values. Where available and appropriate in terms of timing, reported data and projections provided in the integrated national energy and climate plans should build on and be consistent with Eurostat data and the methodology used for reporting European statistics in accordance with Regulation (EC) No 223/2009. (49) In view of the collective achievement of the objectives of the Energy Union Strategy, in particular the creation of a fully functional and resilient Energy Union, it will be essential for the Commission to assess the draft integrated national energy and climate plans, the integrated national energy and climate plans and, based on progress reports, their implementation. For the first ten-year period, this concerns in particular the achievement of the Union's 2030 targets for energy and climate and national contributions to those targets. Such assessment should be undertaken on a biennial basis, and on an annual basis only where necessary, and should be consolidated in the Commission's State of the Energy Union reports. (50) With due respect to the Commission's right of initiative, the ordinary legislative procedure, and the institutional balance of power, the European Parliament and the Council should address, on an annual basis, the progress achieved by the Energy Union on all dimensions of Energy and Climate policies. (51) The Commission should assess the overall impact of the policies and measures of the integrated national energy and climate plans on the operation of the Union climate and energy policy measures, in particular with regard to the need for additional Union policies and measures in view of the necessary increase in GHG emission reduction and removals in the Union in line with the Paris Agreement commitments. (52) Aviation has impacts on the global climate as a result of the release of CO2 as well as of other emissions, including nitrogen oxides emissions, and mechanisms, such as cirrus cloud enhancement. In the light of the rapidly developing scientific understanding of those impacts, an updated assessment of the non-CO2 impacts of aviation on the global climate is already provided for in Regulation (EU) No 525/2013. The modelling used in this respect should be adapted to scientific progress. Based on its assessments of such impacts, the Commission should, by 1 January 2020, present an updated analysis of the non-CO2 effects of aviation, accompanied, where appropriate, by a proposal on how best to address those effects. (53) In accordance with the current UNFCCC GHG reporting guidelines, the calculation and reporting of methane emissions is based on global warming potentials (GWP) relating to a 100-year time horizon. Given the high GWP and relatively short atmospheric lifetime of methane, leading to a significant impact on the climate in the short and middle term, the Commission should analyse the implications for implementing policies and measures for the purpose of reducing the short- and middle-term impact of methane emissions on Union GHG emissions. The Commission should consider policy options for rapidly addressing methane emissions and should put forward a Union strategic plan for methane as an integral part of the Union's long-term strategy. (54) To help ensure coherence between national and Union policies and objectives of the Energy Union, there should be an ongoing dialogue between the Commission and the Member States and, where appropriate, between the Member States. As appropriate, the Commission should issue recommendations to Member States, including on the level of ambition of the draft integrated national energy and climate plans, on the subsequent implementation of policies and measures of the notified integrated national energy and climate plans, and on other national policies and measures of relevance for the implementation of the Energy Union. Whereas recommendations have no binding force, as set out in Article 288 of the Treaty on the Functioning of the European Union (TFEU), Member States should nevertheless take due account of such recommendations and explain in subsequent progress reports how they have done so. With regard to renewable energy, the Commission assessment is to be based on the objective criteria. If the Commission issues a recommendation with regard to a Member State's draft national plan, it should do so as quickly as possible, having regard, on the one hand, to the need for the Commission to add up certain quantified planned contributions of all Member States in order to assess the ambition at Union level, and, on the other, the need to provide adequate time for the Member State concerned to take due consideration of the Commission's recommendations before finalising its national plan, and the need to avoid the risk of delay of the Member State's national plan. (55) Cost-effective deployment of renewable energy is one of the key objective criteria for assessing Member States' contributions. The cost structure of deploying renewable energy is complex and varies significantly between Member States. It includes not only the costs of support schemes, but, inter alia, the connection costs of installations, system backup, providing system security and costs that need to be borne when complying with environmental restrictions. Thus, when comparing Member States based on that criterion, all costs related to deployment, whether they are borne by the Member State, final consumers or project developers, should be accounted for. The Commission's recommendations with regard to the Member States' renewable ambitions should be based on a formula set out in this Regulation which is based on objective criteria. Thus, the assessment of the renewable energy ambition of the Member States should indicate the relative effort made by the Member States, while also taking into consideration relevant circumstances affecting the renewable energy development. The assessment should also include data originating from independent quantitative or qualitative data sources. (56) Should the ambition of integrated national energy and climate plans or their updates be insufficient for the collective achievement of the Energy Union objectives and, for the first period, in particular the 2030 targets for renewable energy and energy efficiency, the Commission should take measures at Union level in order to ensure the collective achievement of those objectives and targets (thereby closing any \u2018ambition gap\u2019). Should progress made by the Union towards those objectives and targets be insufficient for their delivery, the Commission should, in addition to issuing recommendations, propose measures and exercise its powers at Union level or Member States should take additional measures in order to ensure achievement of these objectives and targets (thereby closing any \u2018delivery gap\u2019). Such measures should also take into account early efforts made by Member States towards the 2030 target for renewable energy by reaching in or before 2020 a share of energy from renewable sources above its national binding target, or by making early progress towards its national binding 2020 target or in the implementation of its contribution to the Union's binding target of at least 32 % of renewable energy in 2030. In the area of renewable energy, such measures can also include voluntary financial contributions by Member States to a Union renewable energy financing mechanism managed by the Commission, which would be used to contribute to the most cost-efficient renewable energy projects across the Union, thus providing the Member States with the option to contribute to the Union target achievement at the lowest possible cost. Member States' national renewable energy targets for 2020 should serve as baseline shares of renewable energy from 2021 onwards and should be maintained throughout the period. In the area of energy efficiency, additional measures can, in particular, aim to improve the energy efficiency of products, buildings and transport. (57) Member States' national renewable energy targets for 2020 as set out in Annex I to Directive (EU) 2018/2001 of the European Parliament and of the Council (19) should serve as the starting point for their national indicative trajectory for the period 2021 to 2030, unless a Member State voluntarily decides to set a higher starting point. In addition, they should constitute for this period a mandatory baseline share that forms equally part of Directive (EU) 2018/2001. Consequently, in that period the share of energy from renewable sources in each Member State's gross final consumption of energy should not be lower than its baseline share. (58) If a Member State does not maintain its baseline share as measured over a one-year period, it should, within one year, take additional measures to cover this gap to its baseline scenario. Where a Member State has effectively taken such necessary measures and fulfilled its obligation to cover the gap, it should be deemed to comply with the mandatory requirements of its base-line scenario as from the moment in time when the gap in question occurred and both under this Regulation and under Directive (EU) 2018/2001. (59) In order to enable adequate monitoring and early corrective action by Member States and the Commission, and in order to avoid the \u2018free rider\u2019 effect, the indicative trajectories of all Member States and, as a result, also the indicative trajectory of the Union should reach, in 2022, 2025 and 2027 at least certain minimum percentages of the total increase in renewable energy foreseen for 2030, as set out in this Regulation. The achievement of these \u2018reference points\u2019 in 2022, 2025 and 2027 will be assessed by the Commission on the basis, inter alia, of the Member States' integrated national energy and climate progress reports that Member States should present. Member States below their reference points should explain in their next progress report how they will cover the gap. If the indicative reference points of the Union are not met, Member States below their reference points should cover the gap by implementing additional measures. (60) The Union and the Member States should strive to provide the most up-to-date information on their GHG emissions and removals. This Regulation should enable such estimates to be prepared in the shortest timeframes possible by using statistical and other information, such as, where appropriate, space-based data provided by the Copernicus Programme established by Regulation (EU) No 377/2014 of the European Parliament and of the Council (20) and by other satellite systems. (61) Under Regulation (EU) 2018/842, the approach of the annual commitment cycle taken in Decision No 406/2009/EC of the European Parliament and of the Council (21) should continue. That approach requires a comprehensive review of Member States' GHG inventories to enable the assessment of compliance and the application of corrective action, where necessary. A review process at Union level of the GHG inventories submitted by Member States is necessary to ensure that compliance with Regulation (EU) 2018/842 is assessed in a credible, consistent, transparent and timely manner. (62) Member States and the Commission should ensure close cooperation on all matters relating to the implementation of the Energy Union, with close involvement of the European Parliament on matters related to this Regulation. The Commission should as appropriate assist Member States in implementing this Regulation, particularly with regard to the establishment of the integrated national energy and climate plans and associated capacity building, including by mobilising internal resources from internal modelling capacity and, where appropriate, external expertise. (63) Member States should ensure that their integrated national energy and climate plans take into consideration the latest country-specific recommendations issued in the context of the European Semester. (64) Member States should use the energy efficiency first principle, which means to consider, before taking energy planning, policy and investment decisions, whether cost-efficient, technically, economically and environmentally sound alternative energy efficiency measures could replace in whole or in part the envisaged planning, policy and investment measures, whilst still achieving the objectives of the respective decisions. This includes, in particular, the treatment of energy efficiency as a crucial element and a key consideration in future investment decisions on energy infrastructure in the Union. Such cost-efficient alternatives include measures to make energy demand and energy supply more efficient, in particular by means of cost-effective end-use energy savings, demand response initiatives and more efficient conversion, transmission and distribution of energy. Member States should also encourage the spread of that principle in regional and local government, as well as in the private sector. (65) The European Environment Agency should assist the Commission, as appropriate and in accordance with its annual work programme, with assessment, monitoring and reporting work. (66) The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in order to amend the general framework for the integrated national energy and climate plans template for the purpose of adapting the template to amendments to the Union Energy and Climate policy framework that are directly and specifically related to the Union's contributions under the UNFCCC and the Paris Agreement, take account of changes in the GWPs and internationally agreed inventory guidelines, and set substantive requirements for the Union inventory system and set up the registries. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (22). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. It should also take into account, where necessary, decisions adopted under the UNFCCC and the Paris Agreement. (67) In order to ensure uniform conditions for the implementation of this Regulation, in particular with regard to; integrated national energy and climate progress reports; integrated reporting on national adaptation actions, financial and technology support provided to developing countries and auctioning revenues; annual reporting on approximated GHG inventories, GHG inventories and accounted GHG emissions and removals; the Union renewable energy financing mechanism, national inventory systems; the inventory review; the Union and national systems for policies and measures and projections; and reporting on GHG policies and measures and projections, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 (23). (68) In order to exercise the implementing powers laid down in this Regulation, the Commission should be assisted in its tasks under this Regulation by a Climate Change Committee which reinstates the existing Climate Change Committee established by Article 8 of Decision 93/389/EEC, Article 9 of Decision 280/2004/EC and Article 26 of Regulation (EU) No 525/2013 and by an Energy Union Committee. In order to ensure consistency of policies and aim at maximising synergies between sectors, both climate and energy experts should be invited to the meetings of both committees when implementing this Regulation. (69) The Commission should review the implementation of this Regulation in 2024 and every five years thereafter and make amending proposals as appropriate to ensure the proper implementation thereof and the achievement of its objectives. Those reviews should take into account developments and should be informed by the results of the global stocktake of the Paris Agreement. (70) This Regulation should integrate, amend, replace and withdraw certain planning, reporting and monitoring obligations currently contained in sectoral energy and climate Union legislative acts to ensure a streamlined and integrated approach to the main planning, reporting and monitoring strands. The following legislative acts should therefore be amended accordingly: \u2014 Directive 94/22/EC of the European Parliament and of the Council (24), \u2014 Directive 98/70/EC of the European Parliament and of the Council (25), \u2014 Directive 2009/31/EC of the European Parliament and of the Council (26), \u2014 Regulation (EC) No 663/2009 of the European Parliament and of the Council (27), \u2014 Regulation (EC) No 715/2009 of the European Parliament and of the Council (28), \u2014 Directive 2009/73/EC of the European Parliament and of the Council (29), \u2014 Council Directive 2009/119/EC (30), \u2014 Directive 2010/31/EU of the European Parliament and of the Council (31), \u2014 Directive 2012/27/EU, \u2014 Directive 2013/30/EU of the European Parliament and of the Council (32), \u2014 Council Directive (EU) 2015/652 (33). (71) For reasons of coherence and legal certainty, nothing in this Regulation should prevent the application of the derogations pursuant to the relevant Union sectoral law in the area of electricity and electricity risk preparedness. (72) This Regulation should also integrate in full the provisions of Regulation (EU) No 525/2013. As a consequence, Regulation (EU) No 525/2013 should be repealed from 1 January 2021. However, in order to ensure that the implementation of Decision No 406/2009/EC continues under Regulation (EU) No 525/2013 and that certain aspects linked to the implementation of the Kyoto Protocol remain enshrined in law, it is necessary that certain provisions remain applicable after that date. (73) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States alone and can therefore, by reason of the scale and effects of the proposed action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that article, this Regulation does not go beyond what is necessary to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER 1 General provisions Article 1 Subject matter and scope 1. This Regulation establishes a governance mechanism to: (a) implement strategies and measures designed to meet the objectives and targets of the Energy Union and the long-term Union greenhouse gas emissions commitments consistent with the Paris Agreement, and for the first ten-year period, from 2021 to 2030, in particular the Union's 2030 targets for energy and climate; (b) stimulate cooperation between Member States, including, where appropriate, at regional level, designed to achieve the objectives and targets of the Energy Union; (c) ensure the timeliness, transparency, accuracy, consistency, comparability and completeness of reporting by the Union and its Member States to the UNFCCC and Paris Agreement secretariat; (d) contribute to greater regulatory certainty as well as contribute to greater investor certainty and help take full advantage of opportunities for economic development, investment stimulation, job creation and social cohesion. The governance mechanism is based on long-term strategies, integrated national energy and climate plans covering ten-year periods starting from 2021 to 2030, corresponding integrated national energy and climate progress reports by the Member States and integrated monitoring arrangements by the Commission. The governance mechanism ensures effective opportunities for the public to participate in the preparation of those national plans and those long-term strategies. It comprises a structured, transparent, iterative process between the Commission and Member States for the purpose of the finalisation of the integrated national energy and climate plans and their subsequent implementation, including with regard to regional cooperation, and corresponding Commission action. 2. This Regulation applies to the five dimensions of the Energy Union, which are closely related and mutually reinforcing: (a) energy security; (b) internal energy market; (c) energy efficiency; (d) decarbonisation; and (e) research, innovation and competitiveness. Article 2 Definitions The following definitions apply: (1) \u2018policies and measures\u2019 means all instruments which contribute to meeting the objectives of the integrated national energy and climate plans and/or to implement commitments under points (a) and (b) of Article 4(2) of the UNFCCC, which may include those that do not have the limitation and reduction of greenhouse gas emissions or change in the energy system as a primary objective; (2) \u2018existing policies and measures\u2019 means implemented policies and measures and adopted policies and measures; (3) \u2018implemented policies and measures\u2019 means policies and measures for which one or more of the following applies at the date of submission of the integrated national energy and climate plan or of the integrated national energy and climate progress report: directly applicable Union or national law is in force, one or more voluntary agreements have been established, financial resources have been allocated, human resources have been mobilised; (4) \u2018adopted policies and measures\u2019 means policies and measures for which an official government decision has been made by the date of submission of the integrated national energy and climate plan or of the integrated national energy and climate progress report and there is a clear commitment to proceed with implementation; (5) \u2018planned policies and measures\u2019 means options that are under discussion and that have a realistic chance of being adopted and implemented after the date of submission of the integrated national energy and climate plan or of the integrated national energy and climate progress report; (6) \u2018system for policies and measures and projections\u2019 means a system of institutional, legal and procedural arrangements established for reporting policies and measures and projections relating to anthropogenic emissions by sources and removals by sinks of greenhouse gases and to the energy system, inter alia as required by Article 39; (7) \u2018projections\u2019 means forecasts of anthropogenic greenhouse gas emissions by sources and removals by sinks or developments of the energy system, including at least quantitative estimates for a sequence of four future years ending with 0 or 5 immediately following the reporting year; (8) \u2018projections without measures\u2019 means projections of anthropogenic greenhouse gas emissions by sources and removals by sinks that exclude the effects of all policies and measures which are planned, adopted or implemented after the year chosen as the starting point for the relevant projection; (9) \u2018projections with measures\u2019 means projections of anthropogenic greenhouse gas emissions by sources and removals by sinks that encompass the effects, in terms of greenhouse gas emission reductions or developments of the energy system, of policies and measures that have been adopted and implemented; (10) \u2018projections with additional measures\u2019 means projections of anthropogenic greenhouse gas emissions by sources and removals by sinks or developments of the energy system that encompass the effects, in terms of greenhouse gas emission reductions, of policies and measures which have been adopted and implemented to mitigate climate change or meet energy objectives, as well as policies and measures which are planned for that purpose; (11) \u2018the Union's 2030 targets for energy and climate\u2019 means the Union-wide binding target of at least 40 % domestic reduction in economy-wide greenhouse gas emissions as compared to 1990 to be achieved by 2030, the Union-level binding target of at least 32 % for the share of renewable energy consumed in the Union in 2030, the Union-level headline target of at least 32,5 % for improving energy efficiency in 2030, and the 15 % electricity interconnection target for 2030 or any subsequent targets in this regard agreed by the European Council or by the European Parliament and by the Council for 2030; (12) \u2018national inventory system\u2019 means a system of institutional, legal and procedural arrangements established within a Member State for estimating anthropogenic emissions by sources and removals by sinks of greenhouse gases, and for reporting and archiving inventory information; (13) \u2018indicator\u2019 means a quantitative or qualitative factor or variable that contributes to better understanding progress in implementing; (14) \u2018key indicators\u2019 mean the indicators for the progress made with regard to the five dimensions of the Energy Union as proposed by the Commission; (15) \u2018technical corrections\u2019 means adjustments to the national greenhouse gas inventory estimates made in the context of the review carried out pursuant to Article 38 when the submitted inventory data are incomplete or are prepared in a way that is not consistent with relevant international or Union rules or guidelines and that are intended to replace originally submitted estimates; (16) \u2018quality assurance\u2019 means a planned system of review procedures to ensure that data quality objectives are met and that the best possible estimates and information are reported to support the effectiveness of the quality control programme and to assist Member States; (17) \u2018quality control\u2019 means a system of routine technical activities to measure and control the quality of the information and estimates compiled with the purpose of ensuring data integrity, correctness and completeness, identifying and addressing errors and omissions, documenting and archiving data and other material used, and recording all quality assurance activities; (18) \u2018energy efficiency first\u2019 means taking utmost account in energy planning, and in policy and investment decisions, of alternative cost-efficient energy efficiency measures to make energy demand and energy supply more efficient, in particular by means of cost-effective end-use energy savings, demand response initiatives and more efficient conversion, transmission and distribution of energy, whilst still achieving the objectives of those decisions; (19) \u2018SET-Plan\u2019 means the Strategic Energy Technology Plan as set out in the Commission communication of 15 September 2015, entitled, \u2018Towards an Integrated Strategic Energy Technology (SET) Plan: Accelerating the European Energy System Transformation\u2019; (20) \u2018early efforts\u2019 means: (a) in the context of the assessment of a potential gap between the Union's 2030 target for energy from renewable sources and the collective contributions of Member States, a Member State's achievement of a share of energy from renewable sources above its national binding target for 2020 as set out in Annex I to Directive (EU) 2018/2001 or a Member State's early progress towards its national binding target for 2020; (b) in the context of Commission recommendations based on the assessment pursuant to point (b) of Article 29(1) with regard to energy from renewable sources, a Member State's early implementation of its contribution to the Union's binding target of at least 32 % of renewable energy in 2030 as measured against its national reference points for renewable energy; (21) \u2018regional cooperation\u2019 means cooperation between two or more Member States engaged in a partnership covering one or more of the five dimensions of the Energy Union; (22) \u2018energy from renewable sources\u2019 or \u2018renewable energy\u2019 means energy from renewable sources or renewable energy as defined in point (1) of Article 2 of Directive (EU) 2018/2001; (23) \u2018gross final consumption of energy\u2019 means gross final consumption of energy as defined in point (4) of Article 2 of Directive (EU) 2018/2001; (24) \u2018support scheme\u2019 means support scheme as defined in point (5) of Article 2 of Directive (EU) 2018/2001; (25) \u2018repowering\u2019 means repowering as defined in point (10) of Article 2 of Directive (EU) 2018/2001; (26) \u2018renewable energy community\u2019 means renewable energy community as defined in point (16) of Article 2 of Directive (EU) 2018/2001; (27) \u2018district heating\u2019 or \u2018district cooling\u2019 means district heating or district cooling as defined in point (19) of Article 2 of Directive (EU) 2018/2001; (28) \u2018waste\u2019 means waste as defined in point (23) of Article 2 of Directive (EU) 2018/2001; (29) \u2018biomass\u2019 means biomass as defined in point (24) of Article 2 of Directive (EU) 2018/2001; (30) \u2018agricultural biomass\u2019 means agricultural biomass as defined in point (25) of Article 2 of Directive (EU) 2018/2001; (31) \u2018forest biomass\u2019 means forest biomass as defined in point (26) of Article 2 of Directive (EU) 2018/2001; (32) \u2018biomass fuels\u2019 means biomass fuels as defined in point (27) of Article 2 of Directive (EU) 2018/2001; (33) \u2018biogas\u2019 means biogas as defined in point (28) of Article 2 of Directive (EU) 2018/2001; (34) \u2018bioliquids\u2019 means bioliquids as defined in point (32) of Article 2 of Directive (EU) 2018/2001; (35) \u2018biofuels\u2019 means biofuels as defined in point (33) of Article 2 of Directive (EU) 2018/2001; (36) \u2018advanced biofuels\u2019 means advanced biofuels as defined in point (34) of Article 2 of Directive (EU) 2018/2001; (37) \u2018recycled carbon fuels\u2019 means recycled carbon fuels as defined in point (35) of Article 2 of Directive (EU) 2018/2001; (38) \u2018starch-rich crops\u2019 means starch-rich crops as defined in point (39) of Article 2 of Directive (EU) 2018/2001; (39) \u2018food and feed crops\u2019 means food and feed crops as defined in point (40) of Article 2 of Directive (EU) 2018/2001; (40) \u2018ligno-cellulosic material\u2019 means ligno-cellulosic material as defined in point (41) of Article 2 of Directive (EU) 2018/2001; (41) \u2018residue\u2019 means residue as defined in point (43) of Article 2 of Directive (EU) 2018/2001; (42) \u2018primary energy consumption\u2019 means primary energy consumption as defined in point (2) of Article 2 of Directive 2012/27/EU; (43) \u2018final energy consumption\u2019 means final energy consumption as defined in point (3) of Article 2 of Directive 2012/27/EU; (44) \u2018energy efficiency\u2019 means energy efficiency as defined in point (4) of Article 2 of Directive 2012/27/EU; (45) \u2018energy savings\u2019 means energy savings as defined in point (5) of Article 2 of Directive 2012/27/EU; (46) \u2018energy efficiency improvement\u2019 means energy efficiency improvement as defined in point (6) of Article 2 of Directive 2012/27/EU; (47) \u2018energy service\u2019 means energy service as defined in point (7) of Article 2 of Directive 2012/27/EU; (48) \u2018total useful floor area\u2019 means total useful floor area as defined in point (10) of Article 2 of Directive 2012/27/EU; (49) \u2018energy management system\u2019 means energy management system as defined in point (11) of Article 2 of Directive 2012/27/EU; (50) \u2018obligated party\u2019 means obligated party as defined in point (14) of Article 2 of Directive 2012/27/EU; (51) \u2018implementing public authority\u2019 means implementing public authority as defined in point (17) of Article 2 of Directive 2012/27/EU; (52) \u2018individual action\u2019 means individual action as defined in point (19) of Article 2 of Directive 2012/27/EU; (53) \u2018energy distributor\u2019 means energy distributor as defined in point (20) of Article 2 of Directive 2012/27/EU; (54) \u2018distribution system operator\u2019 means \u2018distribution system operator\u2019 as defined in point (6) of Article 2 of Directive 2009/72/EC and in point (6) of Article 2 of Directive 2009/73/EC; (55) \u2018retail energy sales company\u2019 means retail energy sales company as defined in point (22) of Article 2 of Directive 2012/27/EU; (56) \u2018energy service provider\u2019 means energy service provider as defined in point (24) of Article 2 of Directive 2012/27/EU; (57) \u2018energy performance contracting\u2019 means energy performance contracting as defined in point (27) of Article 2 of Directive 2012/27/EU; (58) \u2018cogeneration\u2019 means cogeneration as defined in point (30) of Article 2 of Directive 2012/27/EU; (59) \u2018building\u2019 means a building as defined in point (1) of Article 2 of Directive 2010/31/EU; (60) \u2018nearly zero-energy building\u2019 means a nearly zero-energy building as defined in point (2) of Article 2 of Directive 2010/31/EU; (61) \u2018heat pump\u2019 means heat pump as defined in point (18) of Article 2 of Directive 2010/31/EU; (62) \u2018fossil fuel\u2019 means non-renewable carbon-based energy sources such as solid fuels, natural gas and oil. CHAPTER 2 Integrated national energy and climate plans Article 3 Integrated national energy and climate plans 1. By 31 December 2019, and subsequently by 1 January 2029 and every ten years thereafter, each Member State shall notify to the Commission an integrated national energy and climate plan. The plans shall contain the elements set out in paragraph 2 of this Article and in Annex I. The first plan shall cover the period from 2021 to 2030, taking into account the longer term perspective. The subsequent plans shall cover the ten-year period immediately following the end of the period covered by the previous plan. 2. The integrated national energy and climate plans shall consist of the following main sections: (a) an overview of the process followed for establishing the integrated national energy and climate plan consisting of an executive summary, a description of the public consultation and involvement of stakeholders and their results, and of regional cooperation with other Member States in preparing the plan, as established in Articles 10, 11 and 12 and in point 1 of Section A of Part I of Annex I; (b) a description of national objectives, targets and contributions relating to the dimensions of the Energy Union, as set out in Article 4 and Annex I; (c) a description of the planned policies and measures in relation to the corresponding objectives, targets and contributions set out under point (b) as well as a general overview of the investment needed to meet the corresponding objectives, targets and contributions; (d) a description of the current situation of the five dimensions of the Energy Union, including with regard to the energy system and greenhouse gas emissions and removals as well as projections with regard to the objectives referred to in point (b) with already existing policies and measures; (e) where applicable, a description of the regulatory and non-regulatory barriers and hurdles to delivering the objectives, targets or contributions related to renewable energy and energy efficiency; (f) an assessment of the impacts of the planned policies and measures to meet the objectives referred to in point (b), including their consistency with the long-term greenhouse gas emission reduction objectives under the Paris Agreement and the long-term strategies as referred to in Article 15; (g) a general assessment of the impacts of the planned policies and measures on competitiveness linked to the five dimensions of the Energy Union; (h) an annex, drawn up in accordance with the requirements and structure laid down in Annex III to this Regulation, setting out the Member State's methodologies and policy measures for achieving the energy savings requirement in accordance with Article 7 of Directive 2012/27/EU and Annex V thereto. 3. With regard to their integrated national energy and climate plans, Member States shall: (a) limit administrative complexity and costs for all relevant stakeholders; (b) take into account the interlinkages between the five dimensions of the Energy Union, in particular the energy efficiency first principle; (c) use robust and consistent data and assumptions across the five dimensions where relevant; (d) assess the number of households in energy poverty taking into account the necessary domestic energy services needed to guarantee basic standards of living in the relevant national context, existing social policy and other relevant policies, as well as indicative Commission guidance on relevant indicators for energy poverty. In the event that a Member State finds, pursuant to point (d) of the first subparagraph, that it has a significant number of households in energy poverty, on the basis of its assessment of verifiable data, it shall include in its plan a national indicative objective to reduce energy poverty. The Member States concerned shall outline in their integrated national energy and climate plans, the policies and measures, which address energy poverty, if any, including social policy measures and other relevant national programmes. 4. Each Member State shall make its integrated national energy and climate plan submitted to the Commission pursuant to this Article publicly available. 5. The Commission is empowered to adopt delegated acts in accordance with Article 43 in order to amend points 2.1.1 and 3.1.1 of Section A and points 4.1 and 4.2.1 of Section B of Part 1, and point 3 of Part 2 of Annex I, for the purpose of adapting them to amendments to the Union Energy and Climate policy framework that are directly and specifically related to the Union's contributions under the UNFCCC and the Paris Agreement. Article 4 National objectives, targets and contributions for the five dimensions of the Energy Union Each Member State shall set out in its integrated national energy and climate plan the following main objectives, targets and contributions, as specified in point 2 of section A of Annex I: (a) as regards the dimension \u2018Decarbonisation\u2019: (1) with respect to greenhouse gas emissions and removals and with a view to contributing to the achievement of the economy wide Union greenhouse gas emission reduction target: (i) the Member State's binding national target for greenhouse gas emissions and the annual binding national limits pursuant to Regulation (EU) 2018/842; (ii) the Member State's commitments pursuant to Regulation (EU) 2018/841; (iii) where applicable to meet the objectives and targets of the Energy Union and the long-term Union greenhouse gas emissions commitments consistent with the Paris Agreement, other objectives and targets, including sector targets and adaptation goals. (2) with respect to renewable energy: With a view to achieving the Union's binding target of at least 32 % renewable energy in 2030 as referred to in Article 3 of Directive (EU) 2018/2001, a contribution to that target in terms of the Member State's share of energy from renewable sources in gross final consumption of energy in 2030, with an indicative trajectory for that contribution from 2021 onwards. By 2022, the indicative trajectory shall reach a reference point of at least 18 % of the total increase in the share of energy from renewable sources between that Member State's binding 2020 national target, and its contribution to the 2030 target. By 2025, the indicative trajectory shall reach a reference point of at least 43 % of the total increase in the share of energy from renewable sources between that Member State's binding 2020 national target and its contribution to the 2030 target. By 2027, the indicative trajectory shall reach a reference point of at least 65 % of the total increase in the share of energy from renewable sources between that Member State's binding 2020 national target and its contribution to the 2030 target. By 2030, the indicative trajectory shall reach at least the Member State's planned contribution. If a Member State expects to surpass its binding 2020 national target, its indicative trajectory may start at the level it is projected to achieve. The Member States' indicative trajectories, taken together, shall add up to the Union reference points in 2022, 2025 and 2027 and to the Union's binding target of at least 32 % renewable energy in 2030. Separately from its contribution to the Union target and its indicative trajectory for the purposes of this Regulation, a Member State shall be free to indicate higher ambitions for national policy purposes; (b) as regards the dimension \u2018Energy Efficiency\u2019: (1) the indicative national energy efficiency contribution to achieving the Union's energy efficiency targets of at least 32,5 % in 2030 as referred to in Article 1(1) and Article 3(5) of Directive 2012/27/EU, based on either primary or final energy consumption, primary or final energy savings, or energy intensity. Member States shall express their contribution in terms of absolute level of primary energy consumption and final energy consumption in 2020, and in terms of absolute level of primary energy consumption and final energy consumption in 2030, with an indicative trajectory for that contribution from 2021 onwards. They shall explain their underlying methodology and the conversion factors used; (2) the cumulative amount of end-use energy savings to be achieved over the period 2021-2030 under point (b) of Article 7(1) on the energy saving obligations pursuant to Directive 2012/27/EU; (3) the indicative milestones of the long-term strategy for the renovation of the national stock of residential and non-residential buildings, both public and private, the roadmap with domestically established measurable progress indicators, an evidence-based estimate of expected energy savings and wider benefits, and the contributions to the Union's energy efficiency targets pursuant to Directive 2012/27/EU in accordance with Article 2a of Directive 2010/31/EU; (4) the total floor area to be renovated or equivalent annual energy savings to be achieved from 2021 to 2030 under Article 5 of Directive 2012/27/EU on the exemplary role of public bodies' buildings; (c) as regards the dimension \u2018Energy Security\u2019: (1) national objectives with regard to: \u2014 increasing the diversification of energy sources and supply from third countries, the purpose of which may be to reduce energy import dependency, \u2014 increasing the flexibility of the national energy system, and \u2014 addressing constrained or interrupted supply of an energy source, for the purpose of improving the resilience of regional and national energy systems, including a timeframe for when the objectives should be met; (d) as regards the dimension \u2018Internal Energy Market\u2019: (1) the level of electricity interconnectivity that the Member State aims for in 2030 in consideration of the electricity interconnection target for 2030 of at least 15 %, with a strategy with the level from 2021 onwards defined in close cooperation with the Member States affected, taking into account the 2020 interconnection target of 10 % and the indicators of the urgency of action based on price differential in the wholesale market, nominal transmission capacity of interconnectors in relation to peak load and to installed renewable generation capacity as set out in point 2.4.1 of Section A of Part I of Annex I. Each new interconnector shall be subject to a socioeconomic and environmental cost-benefit analysis and implemented only if the potential benefits outweigh the costs; (2) key electricity and gas transmission infrastructure projects, and, where relevant, modernisation projects, that are necessary for the achievement of objectives and targets under the five dimensions of the Energy Union; (3) national objectives related to other aspects of the internal energy market such as: increasing system flexibility, in particular through policies and measures related to market-based price formation in compliance with applicable law; market integration and coupling, aiming to increase the tradeable capacity of existing interconnectors, smart grids, aggregation, demand response, storage, distributed generation, mechanisms for dispatching, re-dispatching and curtailment and real-time price signals, including a timeframe for when the objectives should be met, and other national objectives related to the internal energy market as set out in point 2.4.3 of Section A of Part 1 of Annex I; (e) as regards the dimension \u2018Research, Innovation and Competitiveness\u2019: (1) national objectives and funding targets for public and, where available, private research and innovation relating to the Energy Union, including, where appropriate, a timeframe for when the objectives should be met; reflecting the priorities of the Energy Union Strategy and, where relevant, of the SET-Plan. In setting out its objectives, targets and contributions, the Member State may build upon existing national strategies or plans that are compatible with Union law; (2) where available, national 2050 objectives related to the promotion of clean energy technologies. Article 5 Member States' contribution setting process in the area of renewable energy 1. In its contribution for its share of energy from renewable sources in gross final consumption of energy in 2030 and the last year of the period covered for the subsequent national plans, pursuant to point (a)(2) of Article 4, each Member State shall take into account all of the following: (a) the measures provided for in Directive (EU) 2018/2001; (b) the measures adopted to reach the energy efficiency target adopted pursuant to Directive 2012/27/EU; (c) any other existing measures to promote renewable energy within the Member State and, where relevant, at Union level; (d) the binding 2020 national target of energy from renewable sources in its gross final consumption of energy set out in Annex I to Directive (EU) 2018/2001; (e) any relevant circumstances affecting renewable energy deployment, such as: (i) equitable distribution of deployment across the Union; (ii) economic conditions and potential, including GDP per capita; (iii) potential for cost-effective renewable energy deployment; (iv) geographical, environmental and natural constraints, including those of non-interconnected areas and regions; (v) the level of power interconnection between Member States; (vi) other relevant circumstances, in particular early efforts. With regard to point (e) of the first subparagraph, each Member State shall indicate in its integrated national energy and climate plan which relevant circumstances affecting renewable energy deployment it has taken into account. 2. Member States shall collectively ensure that the sum of their contributions amounts to at least 32 % of energy from renewable sources in gross final energy consumption at Union level by 2030. Article 6 Member States' contribution setting process in the area of energy efficiency 1. In its indicative national energy efficiency contribution for 2030 and for the last year of the period covered for the subsequent national plans pursuant to point (b)(1) of Article 4, each Member State shall take into account that, in accordance with Article 3 of Directive 2012/27/EU, the Union's 2020 energy consumption is to be no more than 1 483 Mtoe of primary energy or no more than 1 086 Mtoe of final energy and the Union's 2030 energy consumption is to be no more than 1 273 Mtoe of primary energy and/or no more than 956 Mtoe of final energy. In addition, each Member State shall take into account: (a) the measures provided for in Directive 2012/27/EU; (b) other measures to promote energy efficiency within the Member State and at Union level. 2. In its contribution referred to in paragraph 1, each Member State may take into account national circumstances affecting primary and final energy consumption, such as: (a) remaining cost-effective energy-saving potential; (b) evolution and forecast of gross domestic product; (c) changes of energy imports and exports; (d) changes in the energy mix and the development of carbon capture and storage; and (e) early actions. With regard to the first subparagraph, each Member State shall indicate in its integrated national energy and climate plan which relevant circumstances affecting primary and final energy consumption it has taken into account, if any. Article 7 National policies and measures for each of the five dimensions of the Energy Union Member States shall describe, in accordance with Annex I, in their integrated national energy and climate plan, the main existing and planned policies and measures to achieve in particular the objectives set out in the national plan, including, where applicable, measures providing for regional cooperation and appropriate financing at national and regional level, including mobilisation of Union programmes and instruments. Member States shall provide a general overview of the investment needed to achieve the objectives, targets and contributions set out in the national plan, as well as a general assessment on the sources of that investment. Article 8 Analytical basis of the integrated national energy and climate plans 1. Member States shall describe, in accordance with the structure and format specified in Annex I, the current situation for each of the five dimensions of the Energy Union, including of the energy system and greenhouse gas emissions and removals at the time of submission of the integrated national energy and climate plan or on the basis of the latest available information. Member States shall also set out and describe projections for each of the five dimensions of the Energy Union, for at least the duration of that plan, expected to result from existing policies and measures. Member States shall endeavour to describe additional longer term perspectives for the five dimensions beyond the duration of the integrated national energy and climate plan, where relevant and possible. 2. Member States shall describe in their integrated national energy and climate plan their assessment, at national and, where applicable, regional level, of: (a) the impacts on the development of the energy system and greenhouse gas emissions and removals for the duration of the plan and for a period of ten years following the latest year covered by the plan, under the planned policies and measures or groups of measures, including a comparison with the projections based on existing policies and measures or groups of measures as referred to in paragraph 1; (b) the macroeconomic and, to the extent feasible, the health, environmental, skills and social impact of the planned policies and measures or groups of measures referred to in Article 7 and further specified in Annex I, for the first ten-year period at least until the year 2030, including a comparison with the projections based on existing policies and measures or groups of measures as referred to in paragraph 1 of this Article. The methodology used to assess those impacts shall be made public; (c) interactions between existing policies and measures or groups of measures and planned policies and measures or groups of measures within a policy dimension and between existing policies and measures or groups of measures and planned policies and measures or groups of measures of different dimensions for the first ten-year period at least until the year 2030. Projections concerning security of supply, infrastructure and market integration shall be linked to robust energy efficiency scenarios; (d) the manner in which existing policies and measures and planned policies and measures are to attract the investment necessary for their implementation. 3. Member States shall make available to the public comprehensive information concerning the assumptions, parameters and methodologies used for the final scenarios and projections, taking into account statistical restrictions, commercially sensitive data, and compliance with the data protection rules. Article 9 Draft integrated national energy and climate plans 1. By 31 December 2018, and subsequently by 1 January 2028 and every ten years thereafter, each Member State shall prepare and submit to the Commission a draft of the integrated national energy and climate plan in accordance with Article 3(1) and Annex I. 2. The Commission shall assess the draft integrated national energy and climate plans and may issue country-specific recommendations to Member States in accordance with Article 34 no later than six months before the deadline for submitting those integrated national energy and climate plans. Those recommendations may, in particular, address: (a) the level of ambition of objectives, targets and contributions with a view to collectively achieving the Energy Union objectives and, in particular, the Union's 2030 targets for renewable energy and energy efficiency as well as the level of electricity interconnectivity that the Member State aims for in 2030 as referred to in point (d) of Article 4, taking due account of relevant circumstances affecting the deployment of renewable energy and energy consumption, as indicated by the Member State concerned in the draft integrated national energy and climate plan and the indicators of the urgency of action for interconnectivity established in point 2.4.1 of Section A of Part 1 of Annex I; (b) policies and measures relating to Member State- and Union-level objectives and other policies and measures of potential cross-border relevance; (c) any additional policies and measures that might be required in the integrated national energy and climate plans; (d) interactions between and consistency of existing and planned policies and measures included in the integrated national energy and climate plan within one dimension and among different dimensions of the Energy Union. 3. Each Member State shall take due account of any recommendations from the Commission in its integrated national energy and climate plan. If the Member State concerned does not address a recommendation or a substantial part thereof, that Member State shall provide and make public its reasons. 4. In the context of the public consultation as referred to in Article 10, each Member State shall make available to the public its draft integrated national energy and climate plan. Article 10 Public consultation Without prejudice to any other Union law requirements, each Member State shall ensure that the public is given early and effective opportunities to participate in the preparation of the draft integrated national energy and climate plan \u2014 as regards the plans for the 2021 to 2030 period, in the preparation of the final plan well before its adoption \u2014 as well as of the long-term strategies referred to in Article 15. Each Member State shall attach to the submission of such documents to the Commission a summary of the public's views or provisional views. In so far as Directive 2001/42/EC is applicable, consultations undertaken on the draft in accordance with that Directive shall be deemed to satisfy the obligations to consult the public under this Regulation. Each Member State shall ensure that the public is informed. Each Member State shall set reasonable timeframes allowing sufficient time for the public to be informed, to participate and express its views. Each Member State shall limit administrative complexity when implementing this Article. Article 11 Multilevel climate and energy dialogue Each Member State shall establish a multilevel climate and energy dialogue pursuant to national rules, in which local authorities, civil society organisations, business community, investors and other relevant stakeholders and the general public are able actively to engage and discuss the different scenarios envisaged for energy and climate policies, including for the long term, and review progress, unless it already has a structure which serves the same purpose. Integrated national energy and climate plans may be discussed within the framework of such a dialogue. Article 12 Regional cooperation 1. Member States shall cooperate with each other, taking account of all existing and potential forms of regional cooperation, to meet the objectives, targets and contributions set out in their integrated national energy and climate plan effectively. 2. Each Member State shall, well before submitting its draft integrated national energy and climate plan to the Commission pursuant to Article 9(1) \u2014 as regards the plans for the 2021 to 2030 period, in the preparation of the final plan well before its adoption \u2014 identify opportunities for regional cooperation and consult neighbouring Member States, including in regional cooperation fora. If deemed to be appropriate by the Member State authoring the plan, that Member State may consult other Member States or third countries that have expressed an interest. Insular Member States without energy interconnections to other Member States shall carry out such consultations with neighbouring Member States with maritime borders. The Member States consulted should be given a reasonable time within which to react. Each Member State shall set out in its draft integrated national energy and climate plan \u2014 as regards the plans for the 2021-2030 period, in its final national energy and climate plan \u2014 at least the provisional results of such regional consultations, including, where applicable, how the comments of the Member States or third countries consulted have been taken into account. 3. Member States may engage in voluntary joint drafting of parts of their integrated national energy and climate plans and progress reports, including in regional cooperation fora. If they do so, the result shall replace the equivalent parts of their integrated national energy and climate plan and progress reports. Upon a request by two or more Member States, the Commission shall facilitate that exercise. 4. In order to facilitate market integration and cost-efficient policies and measures, Member States shall, in the period between the deadline for submission of their draft integrated national energy and climate plans and the deadline for submission of their final plans, present the relevant parts of their draft integrated national energy and climate plan in relevant regional cooperation fora with a view to their finalisation. Where necessary, the Commission shall facilitate such cooperation and consultation among the Member States, and if it identifies opportunities for further regional cooperation, it may provide Member States with indicative guidance in order to facilitate the effective cooperation and consultation process. 5. Member States shall consider the comments received from other Member States pursuant to paragraphs 2 and 3 in their final integrated national energy and climate plan, and explain in those plans how such comments have been considered. 6. For the purposes referred to in paragraph 1, Member States shall continue to cooperate at regional level, and, as appropriate, in regional cooperation fora, when implementing the relevant policies and measures of their integrated national energy and climate plans. 7. Member States may also envisage cooperation with signatories to the Energy Community and with third-country members of the European Economic Area. 8. In so far as the provisions of Directive 2001/42/EC are applicable, transboundary consultation undertaken on the draft in accordance with Article 7 of that Directive shall be deemed to satisfy the obligations on regional cooperation pursuant to this Regulation, provided that the requirements of this Article are complied with. Article 13 Assessment of the integrated national energy and climate plans On the basis of the integrated national energy and climate plans and their updates as notified pursuant to Articles 3 and 14, the Commission shall assess, in particular, whether: (a) the objectives, targets and contributions are sufficient for the collective achievement of the Energy Union objectives and, for the first ten-year period in particular, the targets of the Union's 2030 Climate and Energy Framework; (b) the plans comply with requirements of Articles 3 to 12 and Member States have taken due account of the Commission recommendations issued pursuant to Article 34. Article 14 Update of the integrated national energy and climate plan 1. By 30 June 2023, and subsequently by 1 January 2033 and every 10 years thereafter, each Member State shall submit to the Commission a draft update of the latest notified integrated national energy and climate plan or shall provide the Commission with reasons justifying why the plan does not require updating. 2. By 30 June 2024, and subsequently by 1 January 2034 and every 10 years thereafter, each Member State shall submit to the Commission an update of its latest notified integrated national energy and climate plan, unless they have provided reasons why the plan does not require updating pursuant to paragraph 1. 3. In the update referred to in paragraph 2, each Member State shall modify its national objective, target or contribution with regard to any of the quantified Union objectives, targets or contributions set out in point (a)(1) of Article 4 in order to reflect an increased ambition as compared to that set out in its latest notified integrated national energy and climate plan. In the update referred to in paragraph 2, each Member State shall modify its national objective, target, or contribution with regard to any of the quantified Union objectives, targets or contributions set out in points (a)(2) and (b) of Article 4 only in order to reflect an equal or increased ambition as compared to that set out in its latest notified integrated national energy and climate plan. 4. Member States shall make efforts to mitigate in their updated integrated national energy and climate plan any adverse environmental impacts that become apparent as part of the integrated reporting pursuant to Articles 17 to 25. 5. In its updates referred to in paragraph 2, Member States shall take into consideration the latest country-specific recommendations issued in the context of the European Semester as well as obligations deriving from the Paris Agreement. 6. The procedures laid down in Article 9(2) and Articles 10 and 12 shall apply to the preparation and assessment of the updated integrated national energy and climate plans. 7. This Article is without prejudice to the right of Member States to make changes and adaptations in national policies set out or referred to in their integrated national energy and climate plans at any time, provided such changes and adaptations are included in the integrated national energy and climate progress report. CHAPTER 3 Long-term strategies Article 15 Long-term strategies 1. By 1 January 2020, and subsequently by 1 January 2029 and every 10 years thereafter, each Member State shall prepare and submit to the Commission its long-term strategy with a perspective of at least 30 years. Member States should, where necessary, update those strategies every five years. 2. In aiming to achieve the overall climate objectives referred to in paragraph 3, the Commission shall, by 1 April 2019, adopt a proposal for a Union long-term strategy for greenhouse gas emissions reduction in accordance with the Paris Agreement, taking into account the Member States' draft integrated national energy and climate plans. The long-term strategy referred to in this paragraph shall include an analysis covering at least: (a) various scenarios for the Union's contribution towards the objectives set out in paragraph 3 inter alia a scenario on achieving net zero greenhouse gas emissions within the Union by 2050 and negative emissions thereafter; (b) the implications of the scenarios referred to in point (a) on the remaining global and Union carbon budget in order to inform a discussion about cost efficiency, effectiveness and fairness of greenhouse gas emission reduction. 3. The Member States' and the Union's long-term strategies shall contribute to: (a) fulfilling the Union's and the Member States' commitments under the UNFCCC and the Paris Agreement to reduce anthropogenic greenhouse gas emissions and enhance removals by sinks and to promote increased carbon sequestration; (b) fulfilling the objective of the Paris Agreement of holding the increase in the global average temperature to well below 2 \u00b0C above pre-industrial levels and to pursue efforts to limit the temperature increase to 1,5 \u00b0C above pre-industrial levels; (c) achieving long-term greenhouse gas emission reductions and enhancements of removals by sinks in all sectors in accordance with the Union's objective, in the context of necessary reductions according to the Intergovernmental Panel on Climate Change (IPCC) to reduce the Union's greenhouse gas emissions in a cost-effective manner and enhance removals by sinks in pursuit of the temperature goals in the Paris Agreement so as to achieve a balance between anthropogenic emissions by sources and removals by sinks of greenhouse gases within the Union as early as possible and, as appropriate, achieve negative emissions thereafter; (d) a highly energy efficient and highly renewables-based energy system within the Union. 4. Member States' long-term strategies should contain the elements set out in Annex IV. Furthermore, the Member States' and the Union's long-term strategies shall cover: (a) total greenhouse gas emission reductions and enhancements of removals by sinks; (b) emission reductions and enhancements of removals in individual sectors, including electricity, industry, transport, the heating and cooling and buildings sector (residential and tertiary), agriculture, waste and land use, land-use change and forestry (LULUCF); (c) expected progress on transition to a low greenhouse gas emission economy, including greenhouse gas intensity, CO2 intensity of gross domestic product, related estimates of long-term investment, and strategies for related research, development and innovation; (d) to the extent feasible, expected socio-economic effect of the decarbonisation measures, including, inter alia, aspects related to macro-economic and social development, health risks and benefits and environmental protection; (e) links to other national long-term objectives, planning and other policies and measures, and investment. 5. The Commission is empowered to adopt delegated acts in accordance with Article 43 in order to amend Annex IV for the purpose of adapting it to the developments in the Union long-term strategy or in the Union Energy and Climate policy framework that are directly and specifically related to the relevant decisions adopted under the UNFCCC and, in particular, under the Paris Agreement. 6. The integrated national energy and climate plans shall be consistent with the long-term strategies referred to in this Article. 7. Member States and the Commission shall inform and make available to the public forthwith their respective long-term strategies and any updates thereof, including by means of the e-platform referred in Article 28. Member States and the Commission shall make relevant data of the final results available to the public, taking into account commercially sensitive data and compliance with the data protection rules. 8. The Commission shall support Member States in the preparation of their long-term strategies by providing information on the state of the underlying scientific knowledge and opportunities for sharing knowledge and best practices, including, where relevant, guidance for Member States during the development and implementation phase of their strategies. 9. The Commission shall assess whether the national long-term strategies are adequate for the collective achievement of the objectives and targets of the Energy Union set out in Article 1 and shall provide information on any remaining collective gap. Article 16 Strategic plan for methane Given the high global warming potential and relatively short atmospheric lifetime of methane, the Commission shall analyse the implications for implementing policies and measures for the purpose of reducing the short- and middle-term impact of methane emissions on Union greenhouse gas emissions. Taking into account the circular economy objectives as appropriate, the Commission shall consider policy options for rapidly addressing methane emissions and shall put forward a Union strategic plan for methane as an integral part of the Union's long-term strategy referred to in Article 15. CHAPTER 4 Reporting Section 1 Biennial progress reports and their follow up Article 17 Integrated national energy and climate progress reports 1. Without prejudice to Article 26, by 15 March 2023, and every two years thereafter, each Member State shall report to the Commission on the status of implementation of its integrated national energy and climate plan by means of an integrated national energy and climate progress report covering all five dimensions of the Energy Union. 2. The integrated national energy and climate progress report shall cover the following elements: (a) information on the progress accomplished towards reaching the objectives, targets and contributions set out in the integrated national energy and climate plan, and towards financing and implementing the policies and measures necessary to meet them, including a review of actual investment against initial investment assumptions; (b) where applicable, information on the progress in establishing the dialogue referred to in Article 11; (c) the information referred to in Articles 20 to 25 and, where appropriate, updates on policies and measures, in accordance with those articles; (d) information on adaptation in accordance with point (a)(1) of Article 4; (e) as far as possible quantification of the impact of the policies and measures in the integrated national energy and climate plan on air quality and on emissions of air pollutants. The Union and the Member States shall submit biennial reports in accordance with Decision 2/CP.17 of the Conference of the Parties to the UNFCCC, and national communications in accordance with Article 12 of the UNFCCC to the UNFCCC Secretariat. 3. The integrated national energy and climate progress report shall cover the information contained in the annual reports referred to in Article 26(3) and the information on policies and measures and projections of anthropogenic greenhouse gas emissions by sources and removals by sinks contained in the reports referred to in Article 18. 4. The Commission, assisted by the Energy Union Committee referred to in point (b) of Article 44(1), shall adopt implementing acts to set out the structure, format, technical details and process for the information referred to in paragraphs 1 and 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(6). 5. The frequency and scale of the information and updates referred to in point (c) of paragraph 2 shall be balanced against the need to ensure sufficient certainty for investors. 6. Where the Commission has issued recommendations pursuant to Article 32(1) or (2), the Member State concerned shall include in its integrated national energy and climate progress report information on the policies and measures adopted, or intended to be adopted and implemented, to address those recommendations. Where applicable, such information shall include a detailed timetable for implementation. Where the Member State concerned decides not to address a recommendation or a substantial part thereof, it shall provide its reasoning. 7. Member States shall make available to the public the reports submitted to the Commission pursuant to this Article. Article 18 Integrated reporting on greenhouse gas policies and measures and on projections 1. By 15 March 2021, and every two years thereafter, Member States shall report to the Commission information on: (a) their national policies and measures or group of measures as set out in Annex VI; and (b) their national projections of anthropogenic greenhouse gas emissions by sources and removals by sinks, organised by gas or group of gases (Hydrofluorocarbons and Perfluorocarbons) listed in Part 2 of Annex V. National projections shall take into consideration any policies and measures adopted at Union level and shall include the information set out in Annex VII. 2. Member States shall report the most up-to-date projections available. Where a Member State does not submit complete projection estimates by 15 March every second year, and the Commission has established that gaps in the estimates cannot be filled by that Member State once identified through the Commission's quality assurance or quality control procedures, the Commission may prepare estimates as required to compile Union projections, in consultation with the Member State concerned. 3. A Member State shall communicate to the Commission any substantial changes to the information reported pursuant to paragraph 1 during the first year of the reporting period, by 15 March of the year following the previous report. 4. Member States shall make available to the public, in electronic form, their national projections pursuant to paragraph 1 and any relevant assessment of the costs and effects of national policies and measures on the implementation of Union policies relevant for limiting greenhouse gas emissions along with any relevant underpinning technical reports. Those projections and assessments should include descriptions of the models and methodological approaches used, definitions and underlying assumptions. Article 19 Integrated reporting on national adaptation actions, financial and technology support provided to developing countries and auctioning revenues 1. By 15 March 2021, and every two years thereafter, Member States shall report to the Commission information on their national climate change adaptation planning and strategies, outlining their implemented and planned actions to facilitate adaptation to climate change, including the information specified in Part 1 of Annex VIII and in accordance with the reporting requirements agreed upon under the UNFCCC and the Paris Agreement. 2. By 31 July 2021 and every year thereafter (year X), Member States shall report to the Commission information on the use of revenues generated by the Member State by auctioning allowances pursuant to Article 10(1) and Article 3d(1) or (2) of Directive 2003/87/EC, including the information specified in Part 3 of Annex VIII. 3. By 30 September 2021 and every year thereafter (year X), Member States shall report to the Commission information on support to developing countries, including the information specified in Part 2 of Annex VIII and in accordance with the relevant reporting requirements agreed upon under the UNFCCC and the Paris Agreement. 4. Member States shall make available to the public the reports submitted to the Commission pursuant to this Article, with the exception of the information specified in point (b) of Part 2 of Annex VIII. 5. The Commission, assisted by the Climate Change Committee referred to in point (a) of Article 44(1), shall adopt implementing acts to set out the structure, format and submission processes for Member States' reporting of information pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(6). Article 20 Integrated reporting on renewable energy Member States shall include in the integrated national energy and climate progress reports information: (a) on the implementation of the following trajectories and objectives: (1) indicative national trajectory for the overall share of renewable energy in gross final energy consumption from 2021 to 2030; (2) estimated trajectories for the sectoral share of renewable energy in final energy consumption from 2021 to 2030 in the electricity, heating and cooling and transport sector; (3) estimated trajectories per renewable energy technology to achieve the overall and sectoral trajectories for renewable energy from 2021 to 2030, including total expected gross final energy consumption per technology and sector in Mtoe and total planned installed capacity per technology and sector in MW; (4) trajectories on bioenergy demand, disaggregated between heat, electricity and transport, and on biomass supply, by feedstock and origin (distinguishing between domestic production and imports). For forest biomass, an assessment of its source and impact on the LULUCF sink; (5) where applicable, other national trajectories and objectives, including those that are long-term and sectoral (such as share of electricity produced from biomass without the utilisation of heat, share of renewable energy in district heating, renewable energy use in buildings, renewable energy produced by cities, renewable energy communities and renewables self-consumers), energy recovered from the sludge acquired through the treatment of wastewater; (b) on the implementation of the following policies and measures: (1) implemented, adopted and planned policies and measures to achieve the national contribution to the 2030 binding Union target for renewable energy as indicated in point (a)(2) of Article 4 of this Regulation, including sector- and technology-specific measures, with a specific review of the implementation of measures laid down in Articles 23 to 28 of Directive (EU) 2018/2001; (2) where available, specific measures for regional cooperation; (3) without prejudice to Articles 107 and 108 TFEU, specific measures on financial support, including Union support and the use of Union funds, for the promotion of the use of energy from renewable sources in electricity, heating and cooling, and transport; (4) when applicable, the assessment of the support for electricity from renewable sources that Member States are to carry out pursuant to Article 6(4) of Directive (EU) 2018/2001; (5) specific measures to fulfil the requirements of Articles 15 to 18 of Directive (EU) 2018/2001; (6) where applicable, specific measures to assess, make transparent and reduce the need for must-run capacity that can lead to curtailment of energy from renewable sources; (7) a summary of the policies and measures under the enabling framework Member States are to put in place pursuant to Article 21(6) and Article 22(5) of Directive (EU) 2018/2001 to promote and facilitate the development of renewables self-consumption and renewable energy communities; (8) measures promoting the use of energy from biomass, especially for new biomass mobilisation taking into account biomass, including sustainable biomass availability as well as measures for the sustainability of biomass produced and used; (9) measures in place to increase the share of renewable energy in the heating and cooling and transport sector; (10) policies and measures facilitating the uptake of power purchase agreements; (c) as set out in Part 1 of Annex IX. Article 21 Integrated reporting on energy efficiency Member States shall include in the integrated national energy and climate progress reports information: (a) on the implementation of the following national trajectories, objectives and targets: (1) the indicative trajectory for primary and final annual energy consumption from 2021 to 2030 as the national energy savings contribution to achieving the Union-level 2030 target, including the underlying methodology; (2) the indicative milestones of the long-term strategy for the renovation of the national stock of residential and non-residential buildings, both public and private, and the contributions to the Union's energy efficiency targets pursuant to Directive 2012/27/EU in accordance with Article 2a of Directive 2010/31/EU; (3) where applicable, an update of other national objectives set out in the national plan; (b) on the implementation of the following policies and measures: (1) implemented, adopted and planned policies, measures and programmes to achieve the indicative national energy efficiency contribution for 2030 as well as other objectives referred to in Article 6, including planned measures and instruments (also of a financial nature) to promote the energy performance of buildings, measures to utilise energy efficiency potentials of gas and electricity infrastructure and other measures to promote energy efficiency; (2) where applicable, market-based instruments that incentivise energy efficiency improvements, including but not limited to energy taxes, levies and allowances; (3) national energy efficiency obligation scheme and alternative measures pursuant to Article 7a and 7b of Directive 2012/27/EU and in accordance with Annex III to this Regulation; (4) long-term renovation strategies in accordance with Article 2a of Directive 2010/31/EU; (5) policy and measures to promote energy services in the public sector and measures to remove regulatory and non-regulatory barriers that impede the uptake of energy performance contracting and other energy efficiency service models; (6) regional cooperation in the area of energy efficiency, where applicable; (7) without prejudice to Articles 107 and 108 TFEU, financing measures, including Union support and the use of Union funds, in the area of energy efficiency at national level, where applicable; (c) as set out in Part 2 of Annex IX. Article 22 Integrated reporting on energy security Member States shall include in the integrated national energy and climate progress reports information on the implementation of: (a) national objectives for the diversification of energy sources and supply; (b) where applicable, national objectives with regard to reducing energy import dependency from third countries; (c) national objectives for the development of the ability to cope with constrained or interrupted supply of an energy source, including gas and electricity; (d) national objectives with regard to increasing the flexibility of the national energy system, in particular by means of deploying domestic energy sources, demand response and energy storage; (e) implemented, adopted and planned policies and measures to achieve the objectives referred to in points (a) to (d); (f) regional cooperation in implementing the objectives and policies referred to in points (a) to (d); (g) without prejudice to Articles 107 and 108 TFEU, financing measures, including Union support and the use of Union funds, in this area at national level, where applicable. Article 23 Integrated reporting on the internal energy market 1. Member States shall include in their integrated national energy and climate progress reports information on the implementation of the following objectives and measures: (a) the level of electricity interconnectivity that the Member State aims for in 2030 in consideration of the electricity interconnection target for 2030 of at least 15 % and the indicators set out in point 2.4.1 of Section A of Part I of Annex I, as well as measures for the implementation of the strategy for the achievement of this level, including those relating to the granting of authorisations; (b) key electricity and gas transmission infrastructure projects that are necessary for the achievement of objectives and targets under the five dimensions of the Energy Union; (c) where applicable, main infrastructure projects envisaged other than Projects of Common Interest, including infrastructure projects involving third countries, and, to the extent feasible, a general assessment of their compatibility with, and contribution to, the aims and targets of the Energy Union; (d) national objectives related to other aspects of the internal energy market such as increasing system flexibility, market integration and coupling, aiming to increase the tradeable capacity of existing interconnectors, smart grids, aggregation, demand response, storage, distributed generation, mechanisms for dispatching, re-dispatching and curtailment, real-time price signals; (e) where applicable, national objectives and measures related to the non-discriminatory participation of renewable energy, demand response and storage, including via aggregation, in all energy markets; (f) where applicable, national objectives and measures with regard to ensuring that consumers participate in the energy system and benefits from self-generation and new technologies, including smart meters; (g) measures with regard to ensuring electricity system adequacy; (h) implemented, adopted and planned policies and measures to achieve the objectives referred to in points (a) to (g); (i) regional cooperation in implementing the objectives and policies referred to in points (a) to (h); (j) without prejudice to Articles 107 and 108 TFEU, financing measures at national level, including Union support and the use of Union funds, in the area of the internal energy market, including for the electricity interconnection target, where applicable; (k) measures to increase the flexibility of the energy system with regard to renewable energy production, including the roll-out of intraday market coupling and cross-border balancing markets. 2. The information provided by Member States under paragraph 1 shall be consistent with and as appropriate be based on the report by the national regulators referred to in point (e) of Article 37(1) of Directive 2009/72/EC and point (e) of Article 41(1) of Directive 2009/73/EC. Article 24 Integrated Reporting on Energy Poverty Where the second subparagraph of point (d) of Article 3(3) applies, the Member State concerned shall include in its integrated national energy and climate progress report: (a) information on progress towards the national indicative objective to reduce the number of households in energy poverty; and (b) quantitative information on the number of households in energy poverty, and, where available, information on policies and measures addressing energy poverty. The Commission shall share data communicated by Member States pursuant to this Article with the European Energy Poverty Observatory. Article 25 Integrated reporting on research, innovation and competitiveness Member States shall include in their integrated national energy and climate progress reports information on the implementation of the following objectives and measures: (a) where applicable, national objectives and policies translating to a national context the SET Plan objectives and policies; (b) national objectives for total public and, where available, private spending in research and innovation relating to clean energy technologies as well as for technology cost and performance development; (c) where appropriate, national objectives, including long-term targets for 2050 for the deployment of technologies for decarbonising energy- and carbon-intensive industrial sectors and, where applicable, for related carbon transport, use, and storage infrastructure; (d) national objectives to phase out energy subsidies, in particular for fossil fuels; (e) implemented, adopted and planned policies and measures to achieve the objectives referred to in points (b) and (c); (f) cooperation with other Member States in implementing the objectives and policies referred to in points (b) to (d), including coordination of policies and measures in the context of the SET Plan, such as alignment of research programmes and common programmes; (g) financing measures, including Union support and the use of Union funds, in this area at national level, where applicable. Section 2 Annual reporting Article 26 Annual Reporting 1. By 15 March 2021, and every year thereafter (year X), Member States shall report to the Commission: (a) the information referred to in Article 6(2) of Directive 2009/119/EC; (b) the information referred to in point 3 of Annex IX of Directive 2013/30/EU, in accordance with Article 25 of that Directive. 2. By 31 July 2021, and every year thereafter (year X), Member States shall report to the Commission their approximated greenhouse gas inventories for the year X-1. For the purposes of this paragraph, the Commission shall, on the basis of the Member States' approximated greenhouse gas inventories or, if a Member State has not communicated its approximated inventories by that date, on the basis of its own estimates, annually compile a Union approximated greenhouse gas inventory. The Commission shall make that information available to the public by 30 September every year. 3. From 2023, Member States shall determine and report to the Commission final greenhouse gas inventory data by 15 March each year (year X) and preliminary data by 15 January each year, including the greenhouse gases and the inventory information listed in Annex V. The report on the final greenhouse gas inventory data shall also include a complete and up-to-date national inventory report. Within three months of receiving the reports, the Commission shall make the information referred to in point (n) of Part I of Annex V available to the Climate Change Committee referred to in point (a) of Article 44(1). 4. Member States shall submit to the UNFCCC Secretariat national inventories containing the information submitted to the Commission on the final greenhouse gas inventory data in accordance with paragraph 3 by 15 April each year. The Commission shall, in cooperation with the Member States, annually compile a Union greenhouse gas inventory and prepare a Union greenhouse gas inventory report and shall submit them to the UNFCCC Secretariat by 15 April each year. 5. Member States shall report to the Commission the preliminary and the final national inventory data, by 15 January and 15 March respectively in the years 2027 and 2032, prepared for their LULUCF accounts for the purpose of the compliance reports in accordance with Article 14 of Regulation (EU) 2018/841. 6. The Commission is empowered to adopt delegated acts in accordance with Article 43in order to: (a) amend Part 2 of Annex V by adding or deleting substances in the list of greenhouse gases, in accordance with relevant decisions adopted by the bodies of the UNFCCC or of the Paris Agreement; (b) supplement this Regulation by adopting values for global warming potentials and specifying the inventory guidelines applicable in accordance with relevant decisions adopted by the bodies of the UNFCCC or of the Paris Agreement. 7. The Commission, assisted by the Climate Change Committee referred to in point (a) of Article 44(1), shall adopt implementing acts to set out the structure, technical details, format and processes for the Member States' submission of approximated greenhouse gas inventories pursuant to paragraph 2 of this Article, greenhouse gas inventories pursuant to paragraph 3 of this Article and accounted greenhouse gas emissions and removals in accordance with Articles 5 and 14 of Regulation (EU) 2018/841. In proposing such implementing acts the Commission shall take into account the UNFCCC or Paris Agreement timetables for the monitoring and reporting of that information and the relevant decisions adopted by the bodies of the UNFCCC or of the Paris Agreement in order to ensure compliance by the Union with its reporting obligations as a Party to the UNFCCC and the Paris Agreement. Those implementing acts shall also specify the timescales for cooperation and coordination between the Commission and the Member States in preparing the Union greenhouse gas inventory report. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(6). Article 27 Reporting on the 2020 targets By 30 April 2022, each Member State shall report to the Commission on the achievement of its 2020 energy efficiency national target established pursuant to Article 3(1) of Directive 2012/27/EU by providing the information set out in Part 2 of Annex IX to this Regulation, and of the national overall targets for the share of energy from renewable sources in 2020 as set out in Annex I to Directive 2009/28/EC in the version in force on 31 December 2020 by providing the following information: (a) the sectoral (electricity, heating and cooling, and transport) and overall shares of energy from renewable sources in 2020; (b) the measures taken to achieve the 2020 national renewable energy targets, including measures related to support schemes, guarantees of origin and simplification of administrative procedures; (c) the share of energy from biofuels and bioliquids produced from cereal and other starch-rich crops, sugars and oil crops in energy consumption in transport; (d) the share of energy from biofuels and biogas for transport produced from feedstocks and of other fuels listed in Part A of Annex IX to Directive 2009/28/EC in the version in force on 31 December 2020 in energy consumption in transport. Section 3 Reporting platform Article 28 E-platform 1. The Commission shall establish an online platform (e-platform) to facilitate communication between the Commission and Member States, to promote cooperation among Member States and to facilitate public access to information. 2. Member States shall use the e-platform for the purposes of submitting to the Commission the reports referred to in this Chapter once it becomes operational. 3. The e-platform shall become operational by 1 January 2020. The Commission shall use the e-platform to facilitate public online access to the reports referred to in this Chapter, the final integrated national energy and climate plans, the updates thereof, and the long-term strategies referred to in Article 15, taking into account commercially sensitive data and compliance with the data protection rules. CHAPTER 5 Aggregate assessment of progress and policy response to ensure Union targets achievement \u2014 Commission monitoring Article 29 Assessment of progress 1. By 31 October 2021 and every two years thereafter, the Commission shall assess, in particular on the basis of the integrated national energy and climate progress reports, of other information reported under this Regulation, of the indicators and of European statistics and data where available: (a) the progress made at Union level towards meeting the objectives of the Energy Union, including for the first ten-year period the Union's 2030 targets for energy and climate, in particular for the purpose of avoiding any gaps to the Union's 2030 targets for renewable energy and energy efficiency; (b) the progress made by each Member State towards meeting its objectives, targets and contributions and implementing the policies and measures set out in its integrated national energy and climate plan; (c) the overall impact of aviation on the global climate, including through non-CO2 emissions or effects, based on the emission data provided by Member States pursuant to Article 26, and improve that assessment by reference to scientific advancements and air traffic data, as appropriate; (d) the overall impact of the policies and measures of the integrated national energy and climate plans on the operation of the Union climate and energy policy measures; (e) the overall impact of the policies and measures included in the integrated national energy and climate plans on the operation of the European Union's emission trading system (EU ETS) and on the supply-demand balance of allowances in the European carbon market. 2. In the area of renewable energy, as part of its assessment referred to in paragraph 1, the Commission shall assess the progress made in the share of energy from renewable sources in the Union's gross final consumption on the basis of an indicative Union trajectory that starts from 20 % in 2020, reaches reference points of at least 18 % in 2022, 43 % in 2025 and 65 % in 2027 of the total increase in the share of energy from renewable sources between the Union's 2020 renewable energy target and the Union's 2030 renewable energy target, and reaches the Union's 2030 renewable energy target of at least 32 % in 2030. 3. In the area of energy efficiency, as part of its assessment referred to in paragraph 1, the Commission shall assess progress towards collectively achieving a maximum energy consumption at Union level of 1 273 Mtoe of primary energy and 956 Mtoe of final energy in 2030 in accordance with Article 3(5) of Directive 2012/27/EU. In carrying out its assessment, the Commission shall take the following steps: (a) consider whether the Union's milestone of no more than 1 483 Mtoe of primary energy and no more than 1 086 Mtoe of final energy in 2020 is achieved; (b) assess whether Member States' progress indicates that the Union as a whole is on track towards the level of energy consumption in 2030 as referred to in the first subparagraph, taking into account the assessment of information provided by Member States in their integrated national energy and climate progress reports; (c) use results from modelling exercises in relation to future trends in energy consumption at Union level and national level and use other complementary analysis; (d) take due account of relevant circumstances affecting primary and final energy consumption indicated by the Member States in their integrated national energy and climate plans, in accordance with Article 6(2). 4. In the area of the internal energy market, as part of its assessment referred to in paragraph 1, the Commission shall assess the progress made towards the level of electricity interconnectivity that the Member State aims for in 2030. 5. By 31 October 2021 and every year thereafter, the Commission shall assess, in particular on the basis of the information reported pursuant to this Regulation, whether the Union and its Member States have made sufficient progress towards meeting the following requirements: (a) commitments under Article 4 of the UNFCCC and under Article 3 of the Paris Agreement as set out in decisions adopted by the Conference of the Parties to the UNFCCC, or by the Conference of the Parties to the UNFCCC serving as the meeting of the Parties to the Paris Agreement; (b) obligations set out in Article 4 of Regulation (EU) 2018/842 and in Article 4 of Regulation (EU) 2018/841; (c) the objectives set out in the integrated national energy and climate plan with a view to achieving the Energy Union objectives and for the first ten-year period with a view to fulfilling the 2030 targets for energy and climate. 6. In its assessment the Commission should take into consideration the latest country-specific recommendations issued in the context of the European Semester. 7. The Commission shall report on its assessment in accordance with this Article as part of the State of the Energy Union report referred to in Article 35. Article 30 Inconsistencies with overarching Energy Union objectives and targets under Regulation (EU) 2018/842 1. Based on the assessment pursuant to Article 29, the Commission shall issue recommendations to a Member State pursuant to Article 34 if policy developments in that Member State show inconsistencies with the overarching objectives of the Energy Union. 2. A Member State that intends to use the flexibility pursuant to Article 7 of Regulation (EU) 2018/842 shall, as that information becomes available, include in the integrated national energy and climate plan the level of intended use and the planned policies and measures to fulfil the requirements laid down in Article 4 of Regulation (EU) 2018/841 for the period from 2021 to 2030. Article 31 Response to insufficient ambition of integrated national energy and climate plans 1. Where, on the basis of its assessment of the draft integrated national energy and climate plans pursuant to Article 9 or its assessment of the draft updates of the final plans pursuant to Article 14, and as part of the iterative process, the Commission concludes that the objectives, targets and contributions of the Member States are insufficient for the collective achievement of the Energy Union objectives and in particular, for the first ten-year period, for the Union's binding 2030 target for renewable energy and the Union's 2030 target for energy efficiency, it shall \u2014 as regards the Union's target for renewable energy \u2014 and may \u2014 as regards the other Energy Union objectives \u2014 issue recommendations to Member States whose contributions it deems insufficient to increase their ambition in order to ensure a sufficient level of collective ambition. 2. Where a gap between the Union's 2030 target and the collective contributions of Member States occurs in the area of renewable energy, the Commission shall base its assessment on the formula set out in Annex II which is based on the objective criteria listed in point (e)(i) to (v) of the first subparagraph of Article 5(1), whilst having due regard to relevant circumstances affecting renewable energy deployment as indicated by the Member State in accordance with the second subparagraph of Article 5(1). Where a gap between the Union's 2030 target and the sum of the national contributions occurs in the area of energy efficiency, the Commission shall, in particular, evaluate the relevant circumstances listed in Article 6(2), information provided by Member States in their integrated national energy and climate plans, results from modelling exercises in relation to future trends in energy consumption and other complementary analysis as appropriate. Without prejudice to the other provisions of this Article, and for the sole purpose of assessing whether a gap between the Union's 2030 target and the collective contributions of Member States occurs, the Commission shall, in its assessment, assume a national contribution of the Member States which did not submit their draft integrated national energy and climate plans in accordance with Article 9(1). In its assumption, in the area of renewable energy, the Commission shall take into account the Member State's national binding target for 2020 as set out in Annex I to Directive (EU) 2018/2001, results from modelling exercises on renewable energy development and the results from the formula set out in Annex II to this Regulation. In the area of energy efficiency, it shall take into account modelling exercises in relation to future trends in energy consumption and other complementary analysis as appropriate. In its assessment of the renewable energy contributions, based on the formula set out in Annex II, the Commission shall take into consideration any potential negative impacts on the security of supply and grid stability in small or isolated energy systems or in Member States' systems where there may be significant implications due to the change of synchronous area. In its assessment of the energy efficiency contributions, the Commission shall take into consideration the potential impact on electricity system operation and grid stability in Member States where there may be significant implications due to the change of synchronous area. 3. Where, on the basis of its assessment of the integrated national energy and climate plans and their updates pursuant to Article 14, the Commission concludes that the objectives, targets and contributions of the integrated national energy and climate plans or their updates are insufficient for the collective achievement of the Energy Union objectives and, in particular, for the first ten-year period, for the Union's 2030 targets for renewable energy and energy efficiency, it shall propose measures and exercise its powers at Union level in order to ensure the collective achievement of those objectives and targets. With regard to renewable energy, such measures shall take into consideration the level of ambition of contributions to the Union's 2030 target by Member States set out in the integrated national energy and climate plans and their updates. Article 32 Response to insufficient progress towards the Union's energy and climate objectives and targets 1. Where, on the basis of its assessment pursuant to point (b) of Article 29(1), the Commission concludes that insufficient progress is made by a Member State towards meeting its objectives, targets and contributions, its reference points for renewable energy, or in implementing the policies and measures set out in its integrated national climate and energy plan, it shall issue recommendations to the Member State concerned pursuant to Article 34. In its recommendations in the area of renewable energy, the Commission shall take into consideration the relevant circumstances indicated by the Member State in accordance with the second subparagraph of Article 5(1). The Commission shall also take into consideration renewable energy projects for which a final investment decision has been taken, provided that those projects become operational in the period 2021 to 2030 and have a significant impact on a Member State's national contribution. In its recommendations in the area of energy efficiency, the Commission shall take due account of the objective criteria listed in points (a) and (b) of Article 6(1) and the relevant national circumstances indicated by the Member State in accordance with Article 6(2). 2. Where, on the basis of its aggregate assessment of Member States' integrated national energy and climate progress reports pursuant to point (a) of Article 29(1), and supported by other information sources, as appropriate, the Commission concludes that the Union is at risk of not meeting the objectives of the Energy Union and, in particular, for the first ten-year period, the targets of the Union's 2030 Framework for Climate and Energy, it may issue recommendations to all Member States pursuant to Article 34 to mitigate such a risk. In the area of renewable energy, the Commission shall assess if the national measures provided for in paragraph 3 are sufficient to achieve the Union's renewable energy targets. In the case of insufficient national measures, the Commission shall, as appropriate, propose measures and exercise its power at Union level in addition to those recommendations in order to ensure, in particular, the achievement of the Union's 2030 target for renewable energy. In the area of energy efficiency, the Commission shall as appropriate, propose measures and exercise its powers at Union level in addition to those recommendations in order to ensure, in particular, the achievement of the Union's 2030 target for energy efficiency. In the area of energy efficiency, such additional measures may in particular improve the energy efficiency of: (a) products, pursuant to Directive 2009/125/EC of the European Parliament and of the Council (34) and Regulation (EU) 2017/1369 of the European Parliament and of the Council (35); (b) buildings, pursuant to Directives 2010/31/EU and 2012/27/EU; and (c) transport. 3. Where, in the area of renewable energy the Commission concludes, based on its assessment pursuant to Article 29(1) and (2), that one or more of the reference points of the indicative Union trajectory in 2022, 2025 and 2027 referred to in Article 29(2) were not met, Member States that have fallen below one or more of their national reference points in 2022, 2025 and 2027 as referred to in point (a)(2) of Article 4 shall ensure that additional measures are implemented within one year following the date of reception of the Commission's assessment in order to cover the gap compared to their national reference point, such as: (a) national measures to increase deployment of renewable energy; (b) adjusting the share of renewable energy in the heating and cooling sector set out in Article 23(1) of Directive (EU) 2018/2001; (c) adjusting the share of renewable energy in the transport sector set out in Article 25(1) of Directive (EU) 2018/2001; (d) making a voluntary financial payment to the Union renewable energy financing mechanism set up at Union level, contributing to renewable energy projects and managed directly or indirectly by the Commission as set out in Article 33; (e) using cooperation mechanisms set out in Directive (EU) 2018/2001. Such measures shall take into account the Commission's considerations as set out in the second subparagraph of paragraph 1 of this Article. The Member States concerned shall include those measures as part of their integrated national energy and climate progress report. 4. From 1 January 2021 onwards, the share of energy from renewable sources in each Member State's gross final consumption of energy shall not be lower than a baseline share that is equal to its mandatory national overall target for the share of energy from renewable sources in 2020 set out in Article 3(4) of Directive (EU) 2018/2001. If a Member State does not maintain its baseline share as measured over a one-year period, the Member State concerned shall take, within one year, additional measures such as those as set out in points (a) to (e) of the first subparagraph of paragraph 3 of this Article sufficient to cover the gap within one year. Member States fulfilling the obligation to cover the gap to the baseline shall be deemed to be in compliance with the obligations set out in the first sentence of the first subparagraph of this paragraph and in Article 3(4) of Directive (EU) 2018/2001 throughout the period where the gap occurred. For the purposes of point (d) of the first subparagraph of paragraph 3 of this Article, Member States may use their revenues from annual emission allowances under Directive 2003/87/EC. 5. Where a Member State's share of energy from renewable sources falls below one or more of its national reference points in 2022, 2025 and 2027 as referred to in point (a)(2) of Article 4, it shall include in the next integrated report submitted to the Commission pursuant to Article 17 an explanation of how it will cover the gap compared to its national reference points. 6. Where, in the area of energy efficiency, without prejudice to other measures at Union level pursuant to the third subparagraph of paragraph 2 of this Article, the Commission concludes, based on its assessment pursuant to Article 29(1) and (3), carried out by the years 2022, 2025 and 2027 that progress towards collectively achieving the Union's energy efficiency targets referred to in the first subparagraph of Article 29(3) is insufficient, it shall propose measures and exercise its power at Union level in addition to those set out in Directive 2010/31/EU and Directive 2012/27/EU to ensure that the Union's 2030 energy efficiency targets are met. 7. Each Member State concerned referred to in paragraph 3 of this Article shall detail the additional implemented, adopted and planned measures as part of its following progress report referred to in Article 17. 8. Where, in the area of interconnections, the Commission concludes, based on its assessment pursuant to Article 29(1) and (4), in the year 2025 that progress is insufficient, the Commission shall cooperate with the Member States concerned by the year 2026 with the aim of addressing the circumstances encountered. Article 33 Union renewable energy financing mechanism 1. By 1 January 2021, the Commission shall establish the Union renewable energy financing mechanism referred to in point (d) of Article 32(3) to tender support for new renewable energy projects in the Union with the aim of covering a gap in the indicative Union trajectory. Support may be provided, inter alia, in the form of a premium additional to market prices, and shall be allocated to projects bidding at the lowest cost or premium. 2. Without prejudice to paragraph 1 of this Article, the financing mechanism shall contribute to the enabling framework pursuant to Article 3(4) of Directive (EU) 2018/2001 with the aim of supporting renewable energy deployment across the Union irrespectively of a gap to the indicative Union trajectory. To that end: (a) payments from Member States referred to in Article 32 may be complemented by additional sources, such as Union funds, private sector contributions or additional payments by Member States in order to contribute to the achievement of the Union target; (b) the financing mechanism may, inter alia, provide support in the form of low-interest loans, grants, or a mix of both and may support, inter alia, joint projects between Member States in accordance with Article 9 of Directive (EU) 2018/2001 and Member States' participation in joint projects with third countries referred to in Article 11 of that Directive. 3. Member States shall retain the right to decide whether, and if so, under which conditions, they allow installations located on their territory to receive support from the financing mechanism. 4. The Commission, assisted by the Energy Union Committee referred to in point (b) of Article 44(1), may adopt implementing acts to set out the necessary provisions for the establishment and functioning of the financing mechanism, in particular: (a) the methodology for the calculation of the maximum level of the premium for each tender; (b) the tender design to be applied, including conditions for delivery and associated penalties; (c) the methodology for the calculation of the payments of Member States and the resulting statistical benefits for the contributing Member States; (d) minimum requirements for Member States' participation, having regard to the need to ensure both continuity of the mechanism by means of a sufficient duration of the Member State payment, as well as the maximum amount of flexibility for Member States' participation; (e) provisions ensuring the participation and/or approval of hosting Member States, and where necessary provisions relating to additional system cost charges. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(6). 5. Every year, renewable energy generated by installations financed by the financing mechanism shall be statistically attributed to the participating Member States, reflecting their relative payments. Projects supported by this financing mechanism that are financed by other sources than Member States payments shall not count towards Member States' national contributions but towards the Union binding target pursuant to Article 3(1) of Directive (EU) 2018/2001. Article 34 Commission recommendations to Member States 1. The Commission shall as appropriate issue recommendations to Member States to ensure the achievement of the objectives of the Energy Union. The Commission shall make such recommendations publicly available forthwith. 2. Where reference in this Regulation is made to this Article the following principles shall apply: (a) the Member State concerned shall take due account of the recommendation in a spirit of solidarity between Member States and the Union and between Member States; (b) the Member State shall set out, in its integrated national energy and climate progress report made in the year following the year the recommendation was issued, how it has taken due account of the recommendation. If the Member State concerned decides not to address a recommendation or a substantial part thereof, that Member State shall provide its reasoning; (c) the recommendations should be complementary to the latest country-specific recommendations issued in the context of the European Semester. Article 35 State of the Energy Union report 1. By 31 October of every year, the Commission shall submit to the European Parliament and to the Council a State of the Energy Union report. 2. The State of the Energy Union report shall include the following elements: (a) the assessment carried out pursuant to Article 29; (b) where appropriate, recommendations pursuant to Article 34; (c) the report on the functioning of the carbon market referred to in Article 10(5) of Directive 2003/87/EC, including information on the application of that Directive in accordance with Article 21(2) thereof; (d) biennially, from 2023, a report on Union bioenergy sustainability, containing the information specified in Annex X; (e) biennially, a report on voluntary schemes in respect of which the Commission has adopted a decision pursuant to Article 30(4) of Directive (EU) 2018/2001, containing the information specified in Annex XI to this Regulation; (f) an overall progress report on the application of Directive 2009/72/EC; (g) an overall progress report on the application of Directive 2009/73/EC pursuant to Article 52 of that Directive; (h) an overall progress report on energy efficiency obligation schemes and alternative policy measures as referred to in Articles 7a and 7b of Directive 2012/27/EU; (i) biennially, an overall progress report on the renovation of the national stock of residential and non-residential buildings, both public and private, in line with the roadmaps set out in the long-term renovation strategies that each Member State shall establish in accordance with Article 2a of Directive 2010/31/EU; (j) every four years, an overall progress report on Member States' increase in the number of nearly zero-energy buildings in accordance with Article 9(5) of Directive 2010/31/EU; (k) an overall progress report on Member States' progress in creating a complete and operational energy market; (l) actual fuel quality in the different Member States and geographical coverage of fuels with a maximum sulphur content of 10 mg/kg aiming to provide an overview of the fuels quality data in the different Member States as reported pursuant to Directive 98/70/EC; (m) a progress report on competitiveness; (n) Member States' progress towards phasing out energy subsidies, in particular for fossil fuels; (o) other issues of relevance to the implementation of the Energy Union, including public and private support; (p) by 31 October 2019 and every four years thereafter, an assessment of the implementation of Directive 2009/31/EC. Article 36 Monitoring of the governance mechanism In the context of the State of the Energy Union as referred to in Article 35, the Commission shall inform the European Parliament and the Council on the implementation of the integrated national energy and climate plans. The European Parliament and the Council shall, on an annual basis, address the progress achieved by the Energy Union on all dimensions of Energy and Climate policies. CHAPTER 6 Union and national systems on greenhouse gas emissions and removals by sinks Article 37 Union and national inventory systems 1. By 1 January 2021, Member States shall establish, operate and seek to continuously improve national inventory systems to estimate anthropogenic emissions by sources and removals by sinks of greenhouse gases listed in Part 2 of Annex V and to ensure the timeliness, transparency, accuracy, consistency, comparability and completeness of their greenhouse gas inventories. 2. Member States shall ensure that their competent inventory authorities have access to the information specified in Annex XII to this Regulation, make use of reporting systems established pursuant to Article 20 of Regulation (EU) No 517/2014 to improve the estimate of fluorinated gases in the national greenhouse gas inventories and are able to undertake the annual consistency checks referred to in points (i) and (j) of Part 1 of Annex V to this Regulation. 3. A Union inventory system to ensure the timeliness, transparency, accuracy, consistency, comparability and completeness of national inventories with regard to the Union greenhouse gas inventory is hereby established. The Commission shall manage, maintain and seek to continuously improve that system which shall include the setting of a quality assurance and quality control programme, setting quality objectives and drafting an inventory quality assurance and quality control plan, procedures for completing emission estimates to compile the Union inventory pursuant to paragraph 5 of this Article and the reviews referred to in Article 38. 4. The Commission shall perform an initial check of the accuracy of the preliminary greenhouse gas inventory data to be submitted by Member States pursuant to Article 26(3). It shall send the results of that check to Member States within six weeks of the submission deadline. Member States shall respond to any relevant questions raised by the initial check by 15 March, together with the final inventory submission for the year X-2. 5. Where a Member State does not submit the inventory data required to compile the Union inventory by 15 March, the Commission may prepare estimates to complete the data submitted by the Member State, in consultation and close cooperation with the Member State concerned. The Commission shall use, for that purpose, the guidelines applicable for preparing the national greenhouse gas inventories. 6. The Commission, assisted by the Climate Change Committee referred to in point (a) of Article 44(1), shall adopt implementing acts in order to set out rules on the structure, format and submission process of the information relating to national inventory systems and requirements on the establishment, operation and functioning of national inventory systems. In proposing such implementing acts, the Commission shall take into account any relevant decisions adopted by the bodies of the UNFCCC or of the Paris Agreement. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(6). 7. The Commission shall adopt delegated acts in accordance with Article 43 in order to supplement this Regulation by setting out rules concerning the requirements on the establishment, operation and functioning of the Union inventory system. In proposing such delegated acts, the Commission shall take into account any relevant decisions adopted by the bodies of the UNFCCC or of the Paris Agreement. Article 38 Inventory review 1. With a view to monitoring Member States' greenhouse gas emission reductions or limitations pursuant to Articles 4, 9 and 10 of Regulation (EU) 2018/842 and their reduction of emissions and enhancement of removals by sinks pursuant to Articles 4 and 14 of Regulation (EU) 2018/841 and any other greenhouse gas emission reduction or limitation targets set out in Union law, the Commission shall, in 2027 and 2032, carry out a comprehensive review of the national inventory data submitted by Member States pursuant to Article 26(4) of this Regulation. Member States shall participate fully in that process. 2. The comprehensive review referred to in paragraph 1 shall include: (a) checks to verify the transparency, accuracy, consistency, comparability and completeness of information submitted; (b) checks to identify cases where inventory data are prepared in a manner which is inconsistent with UNFCCC guidance documentation or Union rules; (c) checks to identify cases where LULUCF accounting is carried out in a manner which is inconsistent with UNFCCC guidance documentation or Union rules, and (d) where appropriate, calculating the resulting technical corrections necessary, in consultation with the Member States. 3. The Commission, assisted by the Climate Change Committee referred to in point (a) of Article 44(1), shall adopt implementing acts to determine the timing and the procedure for carrying out the comprehensive review, including the tasks set out in paragraph 2 of this Article, and ensuring due consultation of the Member States with regard to the conclusions of the reviews. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(6). 4. The Commission shall, by means of an implementing act, determine the total sum of emissions for the relevant years arising from the corrected inventory data for each Member State upon completion of the review split between emission data relevant for Article 9 of Regulation (EU) 2018/842 and emission data referred to in point (c) of Part 1 of Annex V to this Regulation and also determine the total sum of emissions and removals relevant for Article 4 of Regulation (EU) 2018/841. 5. The data for each Member State as recorded in the registries set up pursuant to Article 15 of Regulation (EU) 2018/841 four months following the date of publication of an implementing act adopted pursuant to paragraph 4 of this Article, shall be used for the compliance check with Article 4 of Regulation (EU) 2018/841, including changes to such data arising as a result of that Member State making use of the flexibilities pursuant to Article 11 of Regulation (EU) 2018/841. 6. The data for each Member State as recorded in the registries set up pursuant to Article 12 of Regulation (EU) 2018/842 two months following the compliance check date with Regulation (EU) 2018/841 referred to in paragraph 5 of this Article, shall be used for the compliance check pursuant to Article 9 of Regulation (EU) 2018/842 for the years 2021 and 2026. The compliance check pursuant to Article 9 of Regulation (EU) 2018/842 for each of the years 2022 to 2025 and 2027 to 2030 shall be performed at a date falling one month following the date of the compliance check for the previous year. This check shall include changes to such data arising as a result of that Member State making use of the flexibilities pursuant to Articles 5, 6 and 7 of Regulation (EU) 2018/842. Article 39 Union and national systems for policies and measures and projections 1. By 1 January 2021, Member States and the Commission shall operate and seek to continuously improve national and Union systems respectively, for reporting on policies and measures and for reporting on projections of anthropogenic greenhouse gas emissions by sources and removals by sinks. Those systems shall include the relevant institutional, legal and procedural arrangements established within a Member State and the Union for evaluating policy and making projections of anthropogenic greenhouse gas emissions by sources and removals by sinks. 2. Member States and the Commission shall aim to ensure the timeliness, transparency, accuracy, consistency, comparability and completeness of the information reported on policies and measures and projections of anthropogenic greenhouse gas emissions by sources and removals by sinks, as referred to in Article 18, including the use and application of data, methods and models, and the implementation of quality assurance and quality control activities and sensitivity analysis. 3. The Commission, assisted by the Climate Change Committee referred to in point (a) of Article 44(1), shall adopt implementing acts to set out the structure, format and submission process of information on national and Union systems for policies and measures and projections pursuant to paragraphs 1 and 2 of this Article and to Article 18. In proposing such implementing acts, the Commission shall take into account the relevant decisions adopted by the bodies of the UNFCCC or of the Paris Agreement, including internationally agreed reporting requirements as well as timetables for monitoring and reporting of that information. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(6). Article 40 Establishment and operation of registries 1. The Union and the Member States shall set up and maintain registries to accurately account for the nationally determined contribution pursuant to Article 4(13) of the Paris Agreement and for internationally transferred mitigation outcomes pursuant to Article 6 of that Agreement. 2. The Union and the Member States may maintain their registries in a consolidated system, together with one or more other Member States. 3. The data in the registries referred to in paragraph 1 of this Article shall be made available to the central administrator designated pursuant to Article 20 of Directive 2003/87/EC. 4. The Commission shall adopt delegated acts in accordance with Article 43 in order to supplement this Regulation by setting up the registries referred to in paragraph 1 of this Article and in order to give effect, by means of the registries of the Union and of the Member States, to the necessary technical implementation of relevant decisions of the UNFCCC or the Paris Agreement bodies, in accordance with paragraph 1 of this Article. CHAPTER 7 Cooperation and support Article 41 Cooperation between the Member States and the Union 1. The Member States shall cooperate and coordinate fully with each other and with the Union in relation to obligations under this Regulation, in particular concerning: (a) the process for preparing, adopting, notifying and assessing the integrated national energy and climate plans pursuant to Articles 9 to 13; (b) the process for preparing, adopting, notifying and assessing the integrated national energy and climate progress report pursuant to Article 17 and annual reporting pursuant to Article 26; (c) the process related to the Commission recommendations and addressing those recommendations pursuant to Article 9(2) and (3), Article 17(6), Article 30(1), Article 31(1) and Article 32(1) and (2); (d) compiling the Union greenhouse gas inventory and preparing the Union greenhouse gas inventory report, pursuant to Article 26(4); (e) preparing the Union national communication pursuant to Article 12 of the UNFCCC and the Union biennial report pursuant to Decision 2/CP.17 or subsequent relevant decisions adopted by the bodies of the UNFCCC; (f) review and compliance procedures under the UNFCCC and the Paris Agreement in accordance with any applicable decision under the UNFCCC as well as the Union's procedure to review Member States greenhouse gas inventories referred to in Article 38; (g) any adjustments following the review process referred to in Article 38 or other changes to inventories and inventory reports submitted, or to be submitted, to the UNFCCC Secretariat; (h) compiling the Union approximated greenhouse gas inventory, pursuant to Article 26(2). 2. The Commission may provide technical support to the Member States in relation to obligations under this Regulation upon request from a Member State. Article 42 Role of the European Environment Agency The European Environment Agency shall assist the Commission in its work as regards the decarbonisation and energy efficiency dimensions to comply with Articles 15 to 21, 26, 28, 29, 35, 37, 38, 39 and 41 in accordance with its annual work programme. That shall include assistance, as required, with: (a) compiling the information reported by Member States on policies and measures and projections; (b) performing quality assurance and quality control procedures on the information reported by Member States on projections and policies and measures; (c) preparing estimates or complementing those available to the Commission for data on projections not reported by the Member States; (d) compiling data, wherever available taken from European statistics and appropriate in terms of timing, as required for the State of the Energy Union report to the European Parliament and to the Council prepared by the Commission; (e) disseminating information collected under this Regulation, including maintaining and updating a database on Member States' mitigation policies and measures and the European Climate Adaptation Platform relating to impacts, vulnerabilities and adaptation to climate change; (f) performing quality assurance and quality control procedures in the preparation of the Union greenhouse gas inventory; (g) compiling the Union greenhouse gas inventory and preparing the Union greenhouse gas inventory report; (h) preparing estimates for data not reported in the national greenhouse gas inventories; (i) conducting the review referred to in Article 38; (j) compiling the Union approximated greenhouse gas inventory. CHAPTER 8 Final provisions Article 43 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 3(5), Article 15(5), Article 26(6), Article 37(7) and Article 40(4) shall be conferred on the Commission for a period of five years from 24 December 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 3(5), Article 15(5), Article 26(6), Article 37(7) and Article 40(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 3(5), Article 15(5), Article 26(6), Article 37(7) and Article 40(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 44 Committees 1. The Commission shall be assisted by: (a) a Climate Change Committee with regard to the implementation of the issues referred to in Article 19(5), Article 26(7), Article 37(6), Article 38(3) and Article 39(3); and (b) an Energy Union Committee with regard to the implementation of issues referred to in Article 17(4) and Article 33(4). 2. Those committees shall be committees within the meaning of Regulation (EU) No 182/2011. 3. The Climate Change Committee referred to in point (a) of paragraph 1 of this Article replaces the committee established in Article 26 of Regulation (EU) No 525/2013. 4. When either of the committees referred to in paragraph 1 considers horizontal issues and common actions, it shall inform the other committee referred to in paragraph 1 accordingly, in order to ensure consistency of policies and to maximise synergies between sectors. 5. Each Member State shall appoint its representative(s) to the Climate Change Committee and the Energy Union Committee. The representatives of each committee shall be invited to the meetings of the other. 6. Where reference is made to this Article, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 45 Review The Commission shall report to the European Parliament and to the Council within six months of each global stocktake agreed under Article 14 of the Paris Agreement on the operation of this Regulation, its contribution to governance of the Energy Union, its contribution to the long-term goals of the Paris Agreement, progress towards the achievement of the 2030 climate and energy targets, additional Energy Union objectives and the conformity of the planning, reporting and monitoring provisions laid down in this Regulation with other Union law or decisions relating to the UNFCCC and the Paris Agreement. The Commission reports may be accompanied by legislative proposals where appropriate. Article 46 Amendments to Directive 94/22/EC Directive 94/22/EC is amended as follows: (1) in Article 8, paragraph 2 is deleted; (2) Article 9 is deleted. Article 47 Amendments to Directive 98/70/EC Directive 98/70/EC is amended as follows: (1) Article 7a is amended as follows: (a) in the third subparagraph of paragraph 1, point (a) is replaced by the following: \u2018(a) the total volume of each type of fuel or energy supplied; and\u2019; (b) in paragraph 2, the introductory wording is replaced by the following: \u20182. Member States shall require suppliers to reduce as gradually as possible life cycle greenhouse gas emissions per unit of energy from fuel and energy supplied by up to 10 % by 31 December 2020, compared with the fuel baseline standard set out in Annex II to Council Directive (EU) 2015/652. That reduction shall consist of:\u2019; (2) in Article 8, paragraph 4 is replaced by the following: \u20184. The Commission shall ensure that the information submitted pursuant to paragraph 3 is promptly made available by appropriate means.\u2019. Article 48 Amendments to Directive 2009/31/EC Directive 2009/31/EC is amended as follows: (1) in Article 27, paragraph 1 is replaced by the following: \u2018Every four years the Member States shall submit to the Commission a report on the implementation of this Directive, including the register referred to in point (b) of Article 25(1). The first report shall be sent to the Commission by 30 June 2011. The report shall be drawn up on the basis of a questionnaire or outline adopted by the Commission in the form of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2). The questionnaire or outline shall be sent to Member States at least six months before the deadline for the submission of the report.\u2019; (2) in Article 38, paragraph 1 is deleted. Article 49 Amendments to Regulation (EC) No 663/2009 Regulation (EC) No 663/2009 is amended as follows: (1) in Article 27, paragraphs 1 and 3 are deleted; (2) Article 28 is deleted. Article 50 Amendment to Regulation (EC) No 715/2009 In Regulation (EC) No 715/2009, Article 29 is deleted. Article 51 Amendments to Directive 2009/73/EC Directive 2009/73/EC is amended as follows: (1) Article 5 is deleted; (2) Article 52 is replaced by the following: \u2018Article 52 Reporting The Commission shall monitor and review the application of this Directive and submit an overall progress report to the European Parliament and to the Council as an annex to the State of the Energy Union Report referred to in Article 35 of Regulation (EU) 2018/1999 of the European Parliament and of the Council (*1). (*1) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1).\u2019.\" Article 52 Amendment to Council Directive 2009/119/EC In Article 6 of Directive 2009/119/EC, paragraph 2 is replaced by the following: \u20182. By 15 March each year, each Member State shall send the Commission a summary copy of the stock register referred to in paragraph 1 showing at least the quantities and nature of the emergency stocks included in the register on the last day of the preceding calendar year.\u2019. Article 53 Amendments to Directive 2010/31/EU Directive 2010/31/EU is amended as follows: (1) Article 2a is amended as follows: (a) in paragraph 1, the introductory wording is replaced by the following: \u20181. Each Member State shall establish a long-term renovation strategy to support the renovation of the national stock of residential and non-residential buildings, both public and private, into a highly energy efficient and decarbonised building stock by 2050, facilitating the cost-effective transformation of existing buildings into nearly zero-energy buildings. Each long-term renovation strategy shall encompass:\u2019; (b) the following paragraph is added: \u20188. Each Member State's long-term renovation strategy shall be submitted to the Commission as part of its final integrated national energy and climate plan referred to in Article 3 of Regulation (EU) 2018/1999 of the European Parliament and of the Council (*2). As a derogation from Article 3(1) of that Regulation, the first long-term renovation strategy under paragraph 1 of this Article shall be submitted to the Commission by 10 March 2020. (*2) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1).\u2019;\" (2) in the second subparagraph of Article 5(2), the sentence \u2018The report may be included in the Energy Efficiency Action Plans referred to in Article 14(2) of Directive 2006/32/EC\u2019 is deleted; (3) in Article 9, paragraph 5 is replaced by the following: \u20185. As part of its State of the Energy Union report referred to in Article 35 of Regulation (EU) 2018/1999, the Commission shall report every four years to the European Parliament and to the Council on the progress of Member States in increasing the number of nearly zero-energy buildings. On the basis of this reported information the Commission shall, where necessary, develop an action plan and propose recommendations and measures in accordance with Article 34 of Regulation (EU) 2018/1999 to increase the number of those buildings and encourage best practices as regards the cost-effective transformation of existing buildings into nearly zero-energy buildings.\u2019; (4) in Article 10, paragraphs 2 and 3 are deleted; (5) in Article 14(3), the third subparagraph is replaced by the following: \u2018Such a report shall be submitted to the Commission as part of the Member States' integrated national energy and climate plans referred to in Article 3 of Regulation (EU) 2018/1999\u2019; (6) in Article 15(3), the third subparagraph is replaced by the following: \u2018Such a report shall be submitted to the Commission as part of the Member States' integrated national energy and climate plans referred to in Article 3 of Regulation (EU) 2018/1999\u2019. Article 54 Amendments to Directive 2012/27/EU Directive 2012/27/EU is amended as follows: (1) Article 4 is deleted; (2) in Article 18(1), point (e) is deleted; (3) Article 24 is amended as follows: (a) paragraphs 1, 3, 4 and 11, are deleted; (b) paragraph 2 is deleted; (4) Annex XIV is deleted. Article 55 Amendment to Directive 2013/30/EU In Article 25 of Directive 2013/30/EU, paragraph 1 is replaced by the following: \u20181. Member States shall report annually to the Commission, as part of the annual reporting referred to in Article 26 of Regulation (EU) 2018/1999 of the European Parliament and of the Council (*3), the information specified in point 3 of Annex IX. Article 56 Amendments to Directive (EU) 2015/652 Directive (EU) 2015/652 is amended as follows: (1) in Article 5, paragraph 1 is replaced by the following: \u20181. Each year by 31 December Member States shall provide the Commission with data for the preceding calendar year related to compliance with Article 7a of Directive 98/70/EC, as defined in Annex III to this Directive.\u2019; (2) in Annex I, Part 2, points 1(h), 2, 3, 4 and 7 are deleted. (3) Annex III is amended as follows: (a) point 1 is replaced by the following: \u20181. Member States are to report the data listed in point 3. Those data must be reported for all fuel and energy placed on the market in each Member State. Where multiple biofuels are blended with fossil fuels, the data for each biofuel must be provided.\u2019; (b) in point 3, points (e) and (f) are deleted; (4) Annex IV is amended as follows: (a) the following templates for reporting information for consistency of the reported data are deleted: \u2014 Origin \u2014 Single Suppliers \u2014 Origin \u2014 Joint Suppliers \u2014 Place of Purchase; (b) in the format notes, points 8 and 9 are deleted. Article 57 Repeal Regulation (EU) No 525/2013 shall be repealed with effect from 1 January 2021, subject to the transitional provisions laid down in Article 58 of this Regulation, with the exception of Article 26(1) of Regulation (EU) No 525/2013 which shall be repealed with effect from 24 December 2018. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XIII. Article 58 Transitional provisions By way of derogation from Article 57 of this Regulation, Article 7 and points (a) and (d) of Article 17(1) of Regulation (EU) No 525/2013 shall continue to apply to the reports containing the data required under those articles for the years 2018, 2019 and 2020. Article 11(3) of Regulation (EU) No 525/2013 shall continue to apply as regards the second commitment period of the Kyoto Protocol. Article 19 of Regulation (EU) No 525/2013 shall continue to apply to the reviews of the greenhouse gas inventory data for the years 2018, 2019 and 2020. Article 22 of Regulation (EU) No 525/2013 shall continue to apply to the submission of the report required under that article. For the purpose of coherence and legal certainty, nothing in this Regulation prevents the application of the derogations pursuant to the relevant Union sectoral law in the area of electricity and electricity risk preparedness. Article 59 Entry into force This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 40, Article 53(2), (3) and (4), point (a) of Article 54(3), Article 54(4), and Article 55 shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 December 2018. For the European Parliament The President A. TAJANI For the Council The President J. BOGNER-STRAUSS (1) OJ C 246, 28.7.2017, p. 34. (2) OJ C 342, 12.10.2017, p. 111. (3) Position of the European Parliament of 13 November 2018 (not yet published in the Official Journal) and Decision of the Council of 4 December 2018. (4) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, p. 16). (5) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1). (6) Council Decision (EU) 2016/1841 of 5 October 2016 on the conclusion, on behalf of the European Union, of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (OJ L 282, 19.10.2016, p. 1). (7) Council Decision 2002/358/EC of 25 April 2002 concerning the approval, on behalf of the European Community, of the Kyoto Protocol to the United Nations Framework Convention on Climate Change and the joint fulfilment of commitments thereunder (OJ L 130, 15.5.2002, p. 1). (8) Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1). (9) Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13). (10) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32). (11) Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ L 33, 4.2.2006, p. 1). (12) Regulation (EC) No 1099/2008 of the European Parliament and of the Council of 22 October 2008 on energy statistics (OJ L 304, 14.11.2008, p. 1). (13) Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, p. 195). (14) Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30). (15) Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (OJ L 115, 25.4.2013, p. 39). (16) Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26). (17) Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1). (18) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (19) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (see page 82 of this Official Journal). (20) Regulation (EU) No 377/2014 of the European Parliament and of the Council of 3 April 2014 establishing the Copernicus Programme and repealing Regulation (EU) No 911/2010 (OJ L 122, 24.4.2014, p. 44). (21) Decision No 406/2009/EC of the European Parliament and of the Council of 23 April 2009 on the effort of Member States to reduce their greenhouse gas emissions to meet the Community's greenhouse gas emission reduction commitments up to 2020 (OJ L 140, 5.6.2009, p. 136). (22) OJ L 123, 12.5.2016, p. 1. (23) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (24) Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorizations for the prospection, exploration and production of hydrocarbons (OJ L 164, 30.6.1994, p. 3). (25) Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58). (26) Directive 2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive 85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC, 2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (OJ L 140, 5.6.2009, p. 114). (27) Regulation (EC) No 663/2009 of the European Parliament and of the Council of 13 July 2009 establishing a programme to aid economic recovery by granting Community financial assistance to projects in the field of energy (OJ L 200, 31.7.2009, p. 31). (28) Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (OJ L 211, 14.8.2009, p. 36). (29) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94). (30) Council Directive 2009/119/EC of 14 September 2009 imposing an obligation on Member States to maintain minimum stocks of crude oil and/or petroleum products (OJ L 265, 9.10.2009, p. 9). (31) Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13). (32) Directive 2013/30/EU of the European Parliament and of the Council of 12 June 2013 on safety of offshore oil and gas operations and amending Directive 2004/35/EC (OJ L 178, 28.6.2013, p. 66). (33) Council Directive (EU) 2015/652 of 20 April 2015 laying down calculation methods and reporting requirements pursuant to Directive 98/70/EC of the European Parliament and of the Council relating to the quality of petrol and diesel fuels (OJ L 107, 25.4.2015, p. 26). (34) Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10). (35) Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1). ANNEX I GENERAL FRAMEWORK FOR INTEGRATED NATIONAL ENERGY AND CLIMATE PLANS Part 1 General framework SECTION A: NATIONAL PLAN 1. OVERVIEW AND PROCESS FOR ESTABLISHING THE PLAN 1.1. Executive summary i. Political, economic, environmental, and social context of the plan ii. Strategy relating to the five dimensions of the Energy Union iii. Overview table with key objectives, policies and measures of the plan 1.2. Overview of current policy situation i. National and Union energy system and policy context of the national plan ii. Current energy and climate policies and measures relating to the five dimensions of the Energy Union iii. Key issues of cross-border relevance iv. Administrative structure of implementing national energy and climate policies 1.3. Consultations and involvement of national and Union entities and their outcome i. Involvement of the national parliament ii. Involvement of local and regional authorities iii. Consultations of stakeholders, including the social partners, and engagement of civil society and the general public iv. Consultations of other Member States v. Iterative process with the Commission 1.4. Regional cooperation in preparing the plan i. Elements subject to joint or coordinated planning with other Member States ii. Explanation of how regional cooperation is considered in the plan 2. NATIONAL OBJECTIVES AND TARGETS 2.1. Dimension decarbonisation 2.1.1. GHG emissions and removals (1) i. The elements set out in point (a)(1) of Article 4 ii. Where applicable, other national objectives and targets consistent with the Paris Agreement and the existing long-term strategies. Where applicable for the contribution to the overall Union commitment of reducing the GHG emissions, other objectives and targets, including sector targets and adaptation goals, if available 2.1.2. Renewable energy i. The elements set out in point (a)(2) of Article 4 ii. Estimated trajectories for the sectoral share of renewable energy in final energy consumption from 2021 to 2030 in the electricity, heating and cooling, and transport sector iii. Estimated trajectories by renewable energy technology that the Member State projects to use to achieve the overall and sectoral trajectories for renewable energy from 2021 to 2030, including expected total gross final energy consumption per technology and sector in Mtoe and total planned installed capacity (divided by new capacity and repowering) per technology and sector in MW iv. Estimated trajectories on bioenergy demand, disaggregated between heat, electricity and transport, and on biomass supply by feedstocks and origin (distinguishing between domestic production and imports). For forest biomass, an assessment of its source and impact on the LULUCF sink v. Where applicable, other national trajectories and objectives, including those that are long term or sectoral (e.g. share of renewable energy in district heating, renewable energy use in buildings, renewable energy produced by cities, renewable energy communities and renewables self-consumers, energy recovered from the sludge acquired through the treatment of wastewater) 2.2. Dimension energy efficiency i. The elements set out in point (b) of Article 4 ii. The indicative milestones for 2030, 2040 and 2050, the domestically established measurable progress indicators, an evidence-based estimate of expected energy savings and wider benefits, and their contributions to the Union's energy efficiency targets as included in the roadmaps set out in the long-term renovation strategies for the national stock of residential and non-residential buildings, both public and private, in accordance with Article 2a of Directive 2010/31/EU iii. Where applicable, other national objectives, including long-term targets or strategies and sectoral targets, and national objectives in areas such as energy efficiency in the transport sector and with regard to heating and cooling 2.3. Dimension energy security i. The elements set out in point (c) of Article 4 ii. National objectives with regard to increasing: the diversification of energy sources and supply from third countries for the purpose of increasing the resilience of regional and national energy systems iii. Where applicable, national objectives with regard to reducing energy import dependency from third countries, for the purpose of increasing the resilience of regional and national energy systems iv. National objectives with regard to increasing the flexibility of the national energy system, in particular by means of deploying domestic energy sources, demand response and energy storage 2.4. Dimension internal energy market 2.4.1. Electricity interconnectivity i. The level of electricity interconnectivity that the Member State aims for in 2030 in consideration of the electricity interconnection target for 2030 of at least 15 %, with a strategy with the level from 2021 onwards defined in close cooperation with affected Member States, taking into account the 2020 interconnection target of 10 % and the following indicators of the urgency of action: (1) Price differential in the wholesale market exceeding an indicative threshold of EUR 2/MWh between Member States, regions or bidding zones; (2) Nominal transmission capacity of interconnectors below 30 % of peak load; (3) Nominal transmission capacity of interconnectors below 30 % of installed renewable generation. Each new interconnector shall be subject to a socioeconomic and environmental cost-benefit analysis and implemented only if the potential benefits outweigh the costs 2.4.2. Energy transmission infrastructure i. Key electricity and gas transmission infrastructure projects, and, where relevant, modernisation projects, that are necessary for the achievement of objectives and targets under the five dimensions of the Energy Union Strategy ii. Where applicable, main infrastructure projects envisaged other than Projects of Common Interest (PCIs) (2) 2.4.3. Market integration i. National objectives related to other aspects of the internal energy market such as increasing system flexibility, in particular related to the promotion of competitively determined electricity prices in line with relevant sectoral law, market integration and coupling, aimed at increasing the tradeable capacity of existing interconnectors, smart grids, aggregation, demand response, storage, distributed generation, mechanisms for dispatching, re-dispatching and curtailment, and real-time price signals, including a timeframe for when the objectives shall be met ii. Where applicable, national objectives related to the non-discriminatory participation of renewable energy, demand response and storage, including via aggregation, in all energy markets, including a timeframe for when the objectives are to be met iii. Where applicable, national objectives with regard to ensuring that consumers participate in the energy system and benefit from self-generation and new technologies, including smart meters; iv. National objectives with regard to ensuring electricity system adequacy, as well as for the flexibility of the energy system with regard to renewable energy production, including a timeframe for when the objectives are to be met v. Where applicable, national objectives to protect energy consumers and improve the competitiveness of the retail energy sector 2.4.4. Energy poverty Where applicable, national objectives with regard to energy poverty, including a timeframe for when the objectives are to be met 2.5. Dimension research, innovation and competitiveness i. National objectives and funding targets for public and, where available, private research and innovation relating to the Energy Union, including, where appropriate, a timeframe for when the objectives are to be met ii. Where available, national 2050 objectives related to the promotion of clean energy technologies and, where appropriate, national objectives, including long-term targets (2050) for deployment of low-carbon technologies, including for decarbonising energy and carbon-intensive industrial sectors and, where applicable, for related carbon transport and storage infrastructure iii. Where applicable, national objectives with regard to competitiveness 3. POLICIES AND MEASURES 3.1. Dimension decarbonisation 3.1.1. GHG emissions and removals i. Policies and measures to achieve the target set under Regulation (EU) 2018/842 as referred in point 2.1.1 and policies and measures to comply with Regulation (EU) 2018/841, covering all key emitting sectors and sectors for the enhancement of removals, with an outlook to the long-term vision and goal to become a low emission economy and achieving a balance between emissions and removals in accordance with the Paris Agreement ii. Where relevant, regional cooperation in this area iii. Without prejudice to the applicability of State aid rules, financing measures, including Union support and the use of Union funds, in this area at national level, where applicable 3.1.2. Renewable energy i. Policies and measures to achieve the national contribution to the binding 2030 Union target for renewable energy and trajectories as referred to in point (a)(2) Article 4, and, where applicable or available, the elements referred to in point 2.1.2 of this Annex, including sector- and technology-specific measures (3) ii. Where relevant, specific measures for regional cooperation, as well as, as an option, the estimated excess production of energy from renewable sources which could be transferred to other Member States in order to achieve the national contribution and trajectories referred to in point 2.1.2 iii. Specific measures on financial support, where applicable, including Union support and the use of Union funds, for the promotion of the production and use of energy from renewable sources in electricity, heating and cooling, and transport iv. Where applicable, the assessment of the support for electricity from renewable sources that Member States are to carry out pursuant to Article 6(4) of Directive (EU) 2018/2001 v. Specific measures to introduce one or more contact points, streamline administrative procedures, provide information and training, and facilitate the uptake of power purchase agreements Summary of the policies and measures under the enabling framework Member States have to put in place pursuant to Article 21(6) and Article 22(5) of Directive (EU) 2018/2001 to promote and facilitate the development of self-consumption and renewable energy communities vi. Assessment of the necessity to build new infrastructure for district heating and cooling produced from renewable sources vii. Where applicable, specific measures on the promotion of the use of energy from biomass, especially for new biomass mobilisation taking into account: \u2014 biomass availability, including sustainable biomass: both domestic potential and imports from third countries \u2014 other biomass uses by other sectors (agriculture and forest-based sectors); as well as measures for the sustainability of biomass production and use 3.1.3. Other elements of the dimension i. Where applicable, national policies and measures affecting the EU ETS sector and assessment of the complementarity and impacts on the EU ETS ii. Policies and measures to achieve other national targets, where applicable iii. Policies and measures to achieve low emission mobility (including electrification of transport) iv. Where applicable, national policies, timelines and measures planned to phase out energy subsidies, in particular for fossil fuels 3.2. Dimension energy efficiency Planned policies, measures and programmes to achieve the indicative national energy efficiency contributions for 2030 as well as other objectives referred to in point 2.2, including planned measures and instruments (also of a financial nature) to promote the energy performance of buildings, in particular with regard to the following: i. Energy efficiency obligation schemes and alternative policy measures under Articles 7a and 7b and Article 20(6) of Directive 2012/27/EU and to be prepared in accordance with Annex III to this Regulation ii. Long-term renovation strategy to support the renovation of the national stock of residential and non-residential buildings, both public and private (4), including policies, measures and actions to stimulate cost-effective deep renovation and policies and actions to target the worst performing segments of the national building stock, in accordance with Article 2a of Directive 2010/31/EU iii. Description of policy and measures to promote energy services in the public sector and measures to remove regulatory and non-regulatory barriers that impede the uptake of energy performance contracting and other energy efficiency service models (5) iv. Other planned policies, measures and programmes to achieve the indicative national energy efficiency contributions for 2030 as well as other objectives referred to in point 2.2 (for example measures to promote the exemplary role of public buildings and energy-efficient public procurement, measures to promote energy audits and energy management systems (6), consumer information and training measures (7), and other measures to promote energy efficiency (8)) v. Where applicable, a description of policies and measures to promote the role of local renewable energy communities in contributing to the implementation of policies and measures in points i, ii, iii and iv vi. Description of measures to develop measures to utilise energy efficiency potentials of gas and electricity infrastructure (9) vii. Regional cooperation in this area, where applicable viii. Financing measures, including Union support and the use of Union funds, in the area at national level 3.3. Dimension energy security (10) i. Policies and measures related to the elements set out in point 2.3 (11) ii. Regional cooperation in this area iii. Where applicable, financing measures in this area at national level, including Union support and the use of Union funds 3.4. Dimension internal energy market (12) 3.4.1. Electricity infrastructure i. Policies and measures to achieve the targeted level of interconnectivity as set out in point (d) of Article 4 ii. Regional cooperation in this area (13) iii. Where applicable, financing measures in this area at national level, including Union support and the use of Union funds 3.4.2. Energy transmission infrastructure i. Policies and measures related to the elements set out in point 2.4.2, including, where applicable, specific measures to enable the delivery of Projects of Common Interest (PCIs) and other key infrastructure projects ii. Regional cooperation in this area (14) iii. Where applicable, financing measures in this area at national level, including Union support and the use of Union funds 3.4.3. Market integration i. Policies and measures related to the elements set out in point 2.4.3 ii. Measures to increase the flexibility of the energy system with regard to renewable energy production such as smart grids, aggregation, demand response, storage, distributed generation, mechanisms for dispatching, re-dispatching and curtailment, real-time price signals, including the roll-out of intraday market coupling and cross-border balancing markets iii. Where applicable, measures to ensure the non-discriminatory participation of renewable energy, demand response and storage, including via aggregation, in all energy markets iv. Policies and measures to protect consumers, especially vulnerable and, where applicable, energy poor consumers, and to improve the competitiveness and contestability of the retail energy market v. Description of measures to enable and develop demand response, including those addressing tariffs to support dynamic pricing (15) 3.4.4. Energy poverty i. Where applicable, policies and measures to achieve the objectives set out in point 2.4.4 3.5. Dimension research, innovation and competitiveness i. Policies and measures related to the elements set out in point 2.5 ii. Where applicable, cooperation with other Member States in this area, including, where appropriate, information on how the SET Plan objectives and policies are being translated to a national context iii. Where applicable, financing measures in this area at national level, including Union support and the use of Union funds SECTION B: ANALYTICAL BASIS (16) 4. CURRENT SITUATION AND PROJECTIONS WITH EXISTING POLICIES AND MEASURES (17) (18) 4.1. Projected evolution of main exogenous factors influencing energy system and GHG emission developments i. Macroeconomic forecasts (GDP and population growth) ii. Sectoral changes expected to impact the energy system and GHG emissions iii. Global energy trends, international fossil fuel prices, EU ETS carbon price iv. Technology cost developments 4.2. Dimension Decarbonisation 4.2.1. GHG emissions and removals i. Trends in current GHG emissions and removals in the EU ETS, effort sharing and LULUCF sectors and different energy sectors ii. Projections of sectoral developments with existing national and Union policies and measures at least until 2040 (including for the year 2030) 4.2.2. Renewable energy i. Current share of renewable energy in gross final energy consumption and in different sectors (heating and cooling, electricity and transport) as well as per technology in each of these sectors ii. Indicative projections of development with existing policies for the year 2030 (with an outlook to the year 2040) 4.3. Dimension Energy efficiency i. Current primary and final energy consumption in the economy and per sector (including industry, residential, service and transport) ii. Current potential for the application of high-efficiency cogeneration and efficient district heating and cooling (19) iii. Projections considering existing energy efficiency policies, measures and programmes as described in point 1.2.(ii) for primary and final energy consumption for each sector at least until 2040 (including for the year 2030) (20) iv. Cost-optimal levels of minimum energy performance requirements resulting from national calculations, in accordance with Article 5 of Directive 2010/31/EU 4.4. Dimension energy security i. Current energy mix, domestic energy resources, import dependency, including relevant risks ii. Projections of development with existing policies and measures at least until 2040 (including for the year 2030) 4.5. Dimension internal energy market 4.5.1. Electricity interconnectivity i. Current interconnection level and main interconnectors (21) ii. Projections of interconnector expansion requirements (including for the year 2030) (22) 4.5.2. Energy transmission infrastructure i. Key characteristics of the existing transmission infrastructure for electricity and gas (23) ii. Projections of network expansion requirements at least until 2040 (including for the year 2030) (24) 4.5.3. Electricity and gas markets, energy prices i. Current situation of electricity and gas markets, including energy prices ii. Projections of development with existing policies and measures at least until 2040 (including for the year 2030) 4.6. Dimension research, innovation and competitiveness i. Current situation of the low-carbon-technologies sector and, to the extent possible, its position on the global market (that analysis is to be carried out at Union or global level) ii. Current level of public and, where available, private research and innovation spending on low-carbon-technologies, current number of patents, and current number of researchers iii. Breakdown of current price elements that make up the main three price components (energy, network, taxes/levies) iv. Description of energy subsidies, including for fossil fuels 5. IMPACT ASSESSMENT OF PLANNED POLICIES AND MEASURES (25) 5.1. Impacts of planned policies and measures described in section 3 on energy system and GHG emissions and removals, including comparison to projections with existing policies and measures (as described in section 4). i. Projections of the development of the energy system and GHG emissions and removals as well as, where relevant of emissions of air pollutants in accordance with Directive (EU) 2016/2284 under the planned policies and measures at least until ten years after the period covered by the plan (including for the last year of the period covered by the plan), including relevant Union policies and measures. ii. Assessment of policy interactions (between existing policies and measures and planned policies and measures within a policy dimension and between existing policies and measures and planned policies and measures of different dimensions) at least until the last year of the period covered by the plan, in particular to establish a robust understanding of the impact of energy efficiency / energy savings policies on the sizing of the energy system and to reduce the risk of stranded investment in energy supply iii. Assessment of interactions between existing policies and measures and planned policies and measures, and between those policies and measures and Union climate and energy policy measures 5.2. Macroeconomic and, to the extent feasible, the health, environmental, employment and education, skills and social impacts, including just transition aspects (in terms of costs and benefits as well as cost-effectiveness) of the planned policies and measures described in section 3 at least until the last year of the period covered by the plan, including comparison to projections with existing policies and measures 5.3. Overview of investment needs i. existing investment flows and forward investment assumptions with regard to the planned policies and measures ii. sector or market risk factors or barriers in the national or regional context iii. analysis of additional public finance support or resources to fill identified gaps identified under point ii 5.4. Impacts of planned policies and measures described in section 3 on other Member States and regional cooperation at least until the last year of the period covered by the plan, including comparison to projections with existing policies and measures i. Impacts on the energy system in neighbouring and other Member States in the region to the extent possible ii. Impacts on energy prices, utilities and energy market integration iii. Where relevant, impacts on regional cooperation Part 2 List of parameters and variables to be reported in Section B of National Plans (26) (27) (28) (29) The following parameters, variables, energy balances and indicators are to be reported in Section B \u2018Analytical Basis\u2019 of the National Plans, if used: 1. General parameters and variables (1) Population [million] (2) GDP [euro million] (3) Sectoral gross value added (including main industrial, construction, services, and agriculture sectors) [euro million] (4) Number of households [thousands] (5) Household size [inhabitants/households] (6) Disposable income of households [euro] (7) Number of passenger-kilometres: all modes, i.e. split between road (cars and buses separated if possible), rail, aviation and domestic navigation (when relevant) [million pkm] (8) Freight transport tonnes-kilometres: all modes excluding international maritime, i.e. split between road, rail, aviation, domestic navigation (inland waterways and national maritime) [million tkm] (9) International oil, gas and coal fuel import prices [EUR/GJ or euro/toe] based on the Commission's recommendations (10) EU-ETS carbon price [EUR/EUA] based on the Commission's recommendations (11) Exchange rates to EUR and to USD (where applicable) assumptions [euro/currency and USD/currency] (12) Number of Heating Degree Days (HDD) (13) Number of Cooling Degree Days (CDD) (14) Technology cost assumptions used in modelling for main relevant technologies 2. Energy balances and indicators 2.1. Energy supply (1) Indigenous Production by fuel type (all energy products that are produced in significant quantities) [ktoe] (2) Net imports by fuel type (including electricity and split into intra- and extra EU net imports) [ktoe] (3) Import dependency from third countries [%] (4) Main import sources (countries) for main energy carriers (including gas and electricity) (5) Gross Inland Consumption by fuel type source (including solids, all energy products: coal, crude oil and petroleum products, natural gas, nuclear energy, electricity, derived heat, renewables, waste) [ktoe] 2.2. Electricity and heat (1) Gross electricity generation [GWh] (2) Gross electricity generation by fuel (all energy products) [GWh] (3) Share of combined heat and power generation in total electricity and heat generation [%] (4) Capacity electricity generation by source, including retirements and new investment [MW] (5) Heat generation from thermal power generation (6) Heat generation from combined heat and power plants, including industrial waste heat (7) Cross-border interconnection capacities for gas and electricity [Definition for electricity in line with outcome of ongoing discussions on basis for 15 % interconnection target] and their projected usage rates 2.3. Transformation sector (1) Fuel inputs to thermal power generation (including solids, oil, gas) [ktoe] (2) Fuel inputs to other conversion processes [ktoe] 2.4. Energy consumption (1) Primary and final energy consumption [ktoe] (2) Final energy consumption by sector (including industry, residential, tertiary, agriculture and transport (including split between passenger and freight transport, when available)) [ktoe] (3) Final energy consumption by fuel (all energy products) [ktoe] (4) Final non-energy consumption [ktoe] (5) Primary energy intensity of the overall economy (primary energy consumption per GDP [toe/euro] (6) Final energy intensity by sector (including industry, residential, tertiary and transport (including split between passenger and freight transport, when available)) 2.5. Prices (1) Electricity prices by type of using sector (residential, industry, tertiary) (2) National retail fuel prices (including taxes, per source and sector) [euro/ktoe] 2.6. Investment Investment costs in energy transformation, supply, transmission and distribution sectors 2.7. Renewables (1) Gross final consumption of energy from renewable sources and share of renewable energy in gross final energy consumption and by sector (electricity, heating and cooling, transport) and by technology (2) Electricity and heat generation from renewable energy in buildings; this shall include, where available, disaggregated data on energy produced, consumed and injected into the grid by solar photovoltaic systems, solar thermal systems, biomass, heat pumps, geothermal systems, as well as all other decentralised renewables systems (3) Where applicable, other national trajectories, including those that are long-term or sectoral the share of food-based and advanced biofuels, the share of renewable energy in district heating, as well as the renewable energy produced by cities and renewable energy communities. 3. GHG emissions and removals related indicators (1) GHG emissions by policy sector (EU ETS, effort sharing and LULUCF) (2) GHG emissions by IPCC sector and by gas (where relevant, split into EU ETS and effort sharing sectors) [tCO2eq] (3) Carbon Intensity of the overall economy [tCO2eq/GDP] (4) CO2 emission related indicators (a) GHG intensity of domestic power and heat generation [tCO2eq/MWh] (b) GHG intensity of final energy consumption by sector [tCO2eq/toe] (5) Non-CO2 emission related parameters (a) Livestock: dairy cattle [1 000 heads], non-dairy cattle [1 000 heads], sheep [1 000 heads], pig [1 000 heads], poultry [1 000 heads] (b) Nitrogen input from application of synthetic fertilisers [kt nitrogen] (c) Nitrogen input from application of manure [kt nitrogen] (d) Nitrogen fixed by N-fixing crops [kt nitrogen] (e) Nitrogen in crop residues returned to soils [kt nitrogen] (f) Area of cultivated organic soils [hectares] (g) Municipal solid waste (MSW) generation (h) Municipal solid waste (MSW) going to landfills (i) Share of CH4 recovery in total CH4 generation from landfills [%] (1) Consistency to be ensured with long-term strategies pursuant to Article 15. (2) In accordance with Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (OJ L 115, 25.4.2013, p. 39). (3) When planning those measures, Member States shall take into account the end of life of existing installations and the potential for repowering. (4) In accordance with Article 2a of Directive 2010/31/EU. (5) In accordance with Article 18 of Directive 2012/27/EU. (6) In accordance with Article 8 of Directive 2012/27/EU. (7) In accordance with Articles 12 and 17 of Directive 2012/27/EU (8) In accordance with Article 19 of Directive 2012/27/EU. (9) In accordance with Article 15(2) of Directive 2012/27/EU. (10) Policies and measures shall reflect the energy efficiency first principle. (11) Consistency shall be ensured with the preventive action and emergency plans under Regulation (EU) 2017/1938 of the European Parliament and of the Council of 25 October 2017 concerning measures to safeguard the security of gas supply and repealing Regulation (EU) No 994/2010 (OJ L 280, 28.10.2017, p. 1) as well as the risk preparedness plans under Regulation (EU) 2018/2001 [as proposed by COM(2016) 862 on risk-preparedness in the electricity sector and repealing Directive 2005/89/EC]. (12) Policies and measures shall reflect the energy efficiency first principle. (13) Other than the PCI Regional Groups established under Regulation (EU) No 347/2013. (14) Other than the PCI Regional Groups established under Regulation (EU) No 347/2013. (15) In accordance with Article 15(8) of Directive 2012/27/EU. (16) See Part 2 for a detailed list of parameters and variables to be reported in Section B of the Plan. (17) Current situation shall reflect the date of submission of the national plan (or latest available date). Existing policies and measures encompass implemented and adopted policies and measures. Adopted policies and measures are those for which an official government decision has been made by the date of submission of the national plan and there is a clear commitment to proceed with implementation. Implemented policies and measures are those for which one or more of the following applies at the date of submission of the integrated national energy and climate plan or the integrated national energy and climate progress report: directly applicable European legislation or national legislation is in force, one or more voluntary agreements have been established, financial resources have been allocated, human resources have been mobilised. (18) The selection of exogenous factors may be based on the assumptions made in the EU Reference Scenario 2016 or other subsequent policy scenarios for the same variables. Besides, Member States specific results of the EU Reference Scenario 2016 as well as results of subsequent policy scenarios may also be a useful source of information when developing national projections with existing policies and measures and impact assessments. (19) In accordance with Article 14(1) of Directive 2012/27/EU. (20) This reference business as usual projection shall be the basis for the 2030 final and primary energy consumption target which is described in 2.3 and conversion factors. (21) With reference to overviews of existing transmission infrastructure by Transmission System Operators (TSOs). (22) With reference to national network development plans and regional investment plans of TSOs. (23) With reference to overviews of existing transmission infrastructure by TSOs. (24) With reference to national network development plans and regional investment plans of TSOs. (25) Planned policies and measures are options under discussion and having a realistic chance of being adopted and implemented after the date of submission of the national plan. The resulting projections under section 5.1.i shall therefore include not only implemented and adopted policies and measures (projections with existing policies and measures), but also planned policies and measures. (26) For the plan covering the period from 2021 to 2030: For each parameter/variable in the list, trends over the years 2005-2040 (2005-2050 where appropriate) including for the year 2030 in five-year intervals shall be reported both in Section 4 and 5. Parameter based on exogenous assumptions v modelling output shall be indicated. (27) As far as possible, reported data and projections shall build on and be consistent with Eurostat data and methodology used for reporting European statistics in the relevant sectoral law, as European statistics are the primary source of statistical data used for reporting and monitoring, in accordance with Regulation (EC) No 223/2009 on European statistics. (28) Note: all projections are to be performed on the basis of constant prices (2016 prices used as base year) (29) The Commission will provide recommendations for key parameters for projections, at least covering oil, gas, and coal import prices as well as EU ETS carbon prices. ANNEX II NATIONAL CONTRIBUTIONS FOR THE SHARE OF ENERGY FROM RENEWABLE SOURCES IN GROSS FINAL CONSUMPTION OF ENERGY IN 2030 1. The following indicative formula represents the objective criteria listed in points (e)(i) to (v) of Article 5(1), each expressed in percentage points: (a) the Member State's national binding target for 2020 as set out in the third column of the table Annex I to Directive (EU) 2018/2001; (b) a flat rate contribution (CFlat); (c) a GDP-per-capita based contribution (CGDP); (d) a potential-based contribution (CPotential); (e) a contribution reflecting the interconnection level of the Member State (CInterco). 2. CFlat shall be the same for each Member State. All Member States' CFlat shall together contribute 30 % of the difference between the Union's targets for 2030 and 2020. 3. CGDP shall be allocated between Member States based on Eurostat's GDP per capita index to the Union average over the 2013 to 2017 period, expressed in purchasing power standard, where for each Member State individually the index is capped at 150 % of the Union average. All Member States' CGDP shall together contribute 30 % of the difference between the Union's targets for 2030 and 2020. 4. CPotential shall be allocated between Member States based on the difference between a Member State's RES share in 2030 as shown in PRIMES scenario and its national binding target for 2020. All Member States' CPotential shall together contribute 30 % of the difference between the Union's targets for 2030 and 2020. 5. CInterco shall be allocated between Member States based on an electricity interconnection share index to Union average in 2017, measured by the net transfer capacity over total installed generation capacity, where for each Member State individually the interconnection share index is capped at 150 % of the Union average. All Member States' CInterco shall together contribute 10 % of the difference between the Union's targets for 2030 and 2020. ANNEX III NOTIFICATION OF MEMBER STATES' MEASURES AND METHODOLOGIES TO IMPLEMENT ARTICLE 7 OF DIRECTIVE 2012/27/EU Member States shall notify to the Commission their proposed detailed methodology pursuant to point 5 of Annex V to Directive 2012/27/EU for the operation of the energy efficiency obligation schemes and alternative policy measures referred to in Articles 7a and 7b and Article 20(6) of that Directive. 1. Calculation of the level of the energy savings requirement to be achieved over the whole period from 1 January 2021 to 31 December 2030, showing how the following elements are taken into account: (a) the annual final energy consumption, averaged over the most recent three-year period prior to 1 January 2019 [in ktoe]; (b) the total cumulative amount of end-use energy savings to be achieved [in ktoe] in accordance with point (b) of Article 7(1) of Directive 2012/27/EU; (c) data used in the calculation of final energy consumption and sources of such data, including justification for the use of alternative statistical sources and any differences of the resulting quantities (if other sources than Eurostat are used); 2. Member States that decide to use any of the possibilities under Article 7(2) of Directive 2012/27/EU shall also notify their calculation of the level of the energy savings requirement to be achieved over the whole period from 1 January 2021 to 31 December 2030, showing how the following elements are taken also into account: (a) their own annual savings rate; (b) their own calculation baseline and energy used in transport, in whole or in part, excluded from the calculation [in ktoe]; (c) calculated cumulative amount of energy savings over the whole period from 1 January 2021 to 31 December 2030 (before application of the options referred to in points (b) to (g) of Article 7(4) of Directive 2012/27/EU) [in ktoe]; (d) application of the options referred to in points (b) to (g) of Article 7(4) of Directive 2012/27/EU: (i) final energy consumption in industrial activities [in ktoe] listed in Annex I to Directive 2003/87/EC excluded from the calculation, in accordance with point (b) of Article 7(4) of Directive 2012/27/EU; (ii) amount of energy savings [in ktoe] achieved in the energy transformation, distribution and transmission sectors, including efficient district heating and cooling infrastructure, in accordance with point (c) of Article 7(4) of Directive 2012/27/EU; (iii) amount of energy savings [in ktoe] resulting from individual actions newly implemented since 31 December 2008 that continue to have an impact in 2020 and beyond, in accordance with point (d) of Article 7(4) of Directive 2012/27/EU; (iv) amount of energy savings [in ktoe] that stem from policy measures, provided it can be demonstrated that those policy measures result in individual actions carried out from 1 January 2018 and until 31 December 2020, which deliver savings after 31 December 2020, in accordance with point (e) of Article 7(4) of Directive 2012/27/EU; (v) amount of energy generated [in ktoe] on or in buildings for own use as a result of policy measures promoting new installation of renewable energy technologies, in accordance with point (f) of Article 7(4)of Directive 2012/27/EU; (vi) amount of energy savings [in ktoe] that exceed the cumulative energy savings required in the period from 1 January 2014 to 31 December 2020, which Member States count towards the period from 1 January 2021 to 31 December 2030 in accordance with point (g) of Article 7(4) of Directive 2012/27/EU; (e) total cumulative amount of energy savings (after application of the options referred to in points (b) to (g) of Article 7(4) of Directive 2012/27/EU). 3. Policy measures in view of the achievement of the savings requirement referred to in Article 7(1) of Directive 2012/27/EU: 3.1. Energy efficiency obligation schemes referred to in Article 7a of Directive 2012/27/EU: (a) description of the energy efficiency obligation scheme; (b) expected cumulative and annual amount of savings and duration of the obligation period(s); (c) obligated parties and their responsibilities; (d) target sectors; (e) eligible actions provided for under the measure; (f) information on the application of the following provisions of Directive 2012/27/EU: (i) where applicable, specific actions, share of savings to be achieved in households affected by energy poverty in accordance with Article 7(11); (ii) savings achieved by energy service providers or other third parties in accordance with point (a) of Article 7a(6); (iii) \u2018banking and borrowing\u2019 in accordance with point (b) of Article 7a(6); (g) where relevant, information on trading of energy savings. 3.2 Alternative measures referred to in Article 7b and Article 20(6) of Directive 2012/27/EU (except taxation): (a) type of policy measure; (b) brief description of the policy measure, including the design features per each policy measure notified; (c) expected total cumulative and annual amount of savings per each measure and/ or amount of energy savings in relation to any intermediate periods; (d) implementing public authorities, participating or entrusted parties and their responsibilities for implementing the policy measure(s); (e) target sectors; (f) eligible actions provided for under the measure; (g) where applicable, specific policy measures or individual actions targeting energy poverty. 3.3. Information on taxation measures: (a) brief description of taxation measure; (b) duration of taxation measure; (c) implementing public authority; (d) expected cumulative and annual amount of savings per measure; (e) target sectors and segment of taxpayers; (f) calculation methodology, including which price elasticities are used and how they have been established, in accordance with point (4) of Annex V to Directive 2012/27/EU. 4. Calculation methodology for measures notified under Articles 7a and 7b and Article 20(6) of Directive 2012/27/EU (except for taxation measures): (a) measurement methods used referred to in point 1 of Annex V to Directive 2012/27/EU; (b) method to express the energy savings (primary or final energy savings); (c) lifetimes of measures, rate at which the savings decline over time and approach used to take into account the lifetime of savings; (d) brief description of the calculation methodology, including how additionality and materiality of savings are ensured and which methodologies and benchmarks are used for deemed and scaled savings; (e) information on how the possible overlaps between the measures and individual actions are addressed to avoid double counting of energy savings; (f) where relevant, climatic variations and approach used. 5. Monitoring and verification (a) brief description of the monitoring and verification system and the process of the verification; (b) implementing public authority and its main responsibilities in charge of monitoring and verification system in relation to the energy efficiency obligation scheme or alternative measures; (c) independence of monitoring and verification from the obligated, participating or entrusted parties; (d) statistically significant proportion of energy efficiency improvement measures and proportion and criteria used to define and select a representative sample; (e) reporting obligations for obligated parties (savings achieved by each obligated party, or each sub-category of obligated party, and in total under the scheme). (f) publication of energy savings achieved (each year) under the energy efficiency obligation scheme and alternative measures; (g) information on Member State law on penalties to be applied in the case of non-compliance; (h) Information on policy measures provided for in the event that progress is not satisfactory. ANNEX IV GENERAL FRAMEWORK FOR LONG-TERM STRATEGIES 1. OVERVIEW AND PROCESS FOR DEVELOPING THE STRATEGIES 1.1. Executive summary 1.2. Legal and policy context 1.3. Public consultation 2. CONTENT 2.1. TOTAL GHG EMISSION REDUCTIONS AND ENHANCEMENTS OF REMOVALS BY SINKS 2.1.1. Projected emission reductions and enhancement of removals by 2050 2.1.2. National target for 2030 and beyond, if available, and indicative milestones for 2040 and 2050 2.1.3. Adaptation policies and measures 2.2. RENEWABLE ENERGY 2.2.1. To the extent feasible, the estimated likely share of renewable energy in final energy consumption by 2050 2.3. ENERGY EFFICIENCY 2.3.1. To the extent feasible, the estimated likely energy consumption by 2050 2.4. SECTOR-SPECIFIC RELATED CONTENT 2.4.1. Energy system 2.4.1.1. Intended or likely future emissions trajectory or range 2.4.1.2. General description of main drivers for energy efficiency, demand-side flexibility and energy consumption and their evolution from 2021 and beyond 2.4.2. Industry 2.4.2.1. Expected emission reductions by sector and energy demands 2.4.2.2. General overview of the policies, existing plans and measures for decarbonisation as described in point 2.1 of Section A of Part I of Annex I 2.4.3. Transport 2.4.3.1. Expected emissions and energy sources by transport type (e.g. cars and vans, heavy duty road transport, shipping, aviation, rail) 2.4.3.2. Decarbonisation options 2.4.4. Agriculture and land use, land-use change and forestry (LULUCF) 2.4.4.1. To the extent feasible, expected emissions by sources and by individual GHGs 2.4.4.2. Emission reduction options envisaged 2.4.4.3. Links to agricultural and rural development policies 3. FINANCING 3.1. Estimates of investment needed 3.2. Policies and measures for related research, development and innovation 4. IMPACT ASSESSMENT OF THE SOCIO-ECONOMIC ASPECTS 5. ANNEXES (as necessary) 5.1. Details on modelling (including assumptions) and/or analysis, indicators, etc. ANNEX V GHG INVENTORIES INFORMATION Part 1 Information to be included in the reports referred to in Article 26(3): (a) their anthropogenic emissions of GHGs listed in Part 2 of this Annex and the anthropogenic emissions of GHGs referred to in Article 2(1) of Regulation (EU) 2018/842 for the year X-2; (b) data on their anthropogenic emissions of carbon monoxide (CO), sulphur dioxide (SO2), nitrogen oxides (NOx) and volatile organic compounds, consistent with data already reported pursuant to Article 8 of Directive (EU) 2016/2284 for the year X-2; (c) their anthropogenic GHG emissions by sources and removals of CO2 by sinks resulting from LULUCF, for the year X-2, in accordance with the methodologies specified in Part 3 of this Annex. This data shall also be relevant for the compliance report under Article 14 of Regulation (EU) 2018/841; (d) any changes to the information referred to in points (a), (b) and (c) for the years between the relevant base year or period and the year X-3, indicating the reasons for those changes; (e) information on indicators, as set out in Part 4 of this Annex, for the year X-2; (f) summary information on concluded transfers pursuant to Article 5 of Regulation (EU) 2018/842 and Articles 12 and 13 of Regulation (EU) 2018/841 for the year X-1; (g) information on the steps taken to improve inventory estimates, in particular in areas of the inventory that have been subject to adjustments or recommendations following expert reviews; (h) the actual or estimated allocation of the verified emissions reported by installation operators under Directive 2003/87/EC to the source categories of the national GHG inventory and the ratio of those verified emissions to the total reported GHG emissions in those source categories, for the year X-2; (i) where relevant, the results of the checks performed on the consistency of the emissions reported in the GHG inventories, for the year X-2, with the verified emissions reported under Directive 2003/87/EC; (j) where relevant, the results of the checks performed on the consistency of the data used to estimate emissions in preparation of the GHG inventories, for the year X-2, with: (i) the data used to prepare inventories of air pollutants pursuant to Directive (EU) 2016/2284; (ii) the data reported pursuant to Article 19(1) of, and Annex VII to, Regulation (EU) No 517/2014; (iii) the energy data reported pursuant to Article 4 of, and Annex B to, Regulation (EC) No 1099/2008; (k) a description of changes to their national inventory system, if any; (l) a description of changes to the national registry, if any; (m) information on their quality assurance and quality control plans, a general uncertainty assessment, a general assessment of completeness and, any other elements of the national GHG inventory report needed to prepare the Union GHG inventory report; (n) information of the Member State's intentions to make use of the flexibilities in Article 5(4) and (5) and Article 7(1) of Regulation (EU) 2018/842 and of the use of revenues under Article 5(6) of that Regulation. A Member State may request to be granted a derogation by the Commission from point (c) of the first paragraph to apply a different methodology from that specified in Part 3 of this Annex where the methodology improvement required cannot be achieved in time for the improvement to be taken into account in the GHG inventories for the period from 2021 to 2030, or where the cost of the methodology improvement would be disproportionately high compared to the benefits of applying such methodology to improve accounting for emissions and removals due to the low significance of the emissions and removals from the carbon pools concerned. Member States wishing to benefit from this derogation shall submit a reasoned request to the Commission by 31 December 2020, indicating by which time the methodology improvement could be implemented, the alternative methodology proposed or both, and an assessment of the potential impacts on the accuracy of accounting. The Commission may request additional information to be submitted within a specific, reasonable time period. Where the Commission considers that the request is justified, it shall grant the derogation. If the Commission rejects the request, it shall give reasons for its decision. Part 2 The GHGs to be covered are: Carbon dioxide (CO2) Methane (CH4) Nitrous Oxide (N2O) Sulphur hexafluoride (SF6) Nitrogen trifluoride (NF3) Hydrofluorocarbons (HFCs): \u2014 HFC-23 CHF3 \u2014 HFC-32 CH2F2 \u2014 HFC-41 CH3F \u2014 HFC-125 CHF2CF3 \u2014 HFC-134 CHF2CHF2 \u2014 HFC-134a CH2FCF3 \u2014 HFC-143 CH2FCHF2 \u2014 HFC-143a CH3CF3 \u2014 HFC-152 CH2FCH2F \u2014 HFC-152a CH3CHF2 \u2014 HFC-161 CH3CH2F \u2014 HFC-227ea CF3CHFCF3 \u2014 HFC-236cb CF3CF2CH2F \u2014 HFC-236ea CF3CHFCHF2 \u2014 HFC-236fa CF3CH2CF3 \u2014 HFC-245fa CHF2CH2CF3 \u2014 HFC-245ca CH2FCF2CHF2 \u2014 HFC-365mfc CH3CF2CH2CF3 \u2014 HFC-43-10mee CF3CHFCHFCF2CF3 or (C5H2F10) Perfluorocarbons (PFCs): \u2014 PFC-14, Perfluoromethane, CF4 \u2014 PFC-116, Perfluoroethane, C2F6 \u2014 PFC-218, Perfluoropropane, C3F8 \u2014 PFC-318, Perfluorocyclobutane, c-C4F8 \u2014 Perfluorocyclopropane c-C3F6 \u2014 PFC-3-1-10, Perfluorobutane, C4F10 \u2014 PFC-4-1-12, Perfluoropentane, C5F12 \u2014 PFC-5-1-14, Perfluorohexane, C6F14 \u2014 PFC-9-1-18, C10F18 Part 3 Methodologies for monitoring and reporting in the LULUCF sector Geographically explicit land-use conversion data in accordance with the 2006 IPCC Guidelines for national GHG inventories. Tier 1 methodology in accordance with the 2006 IPCC guidelines for national GHG inventories. For emissions and removals for a carbon pool that accounts for at least 25-30 % of emissions or removals in a source or sink category which is prioritised within a Member State's national inventory system because its estimate has a significant influence on a country's total inventory of GHGs in terms of the absolute level of emissions and removals, the trend in emissions and removals, or the uncertainty in emissions and removals in the land-use categories, at least Tier 2 methodology in accordance with the 2006 IPCC guidelines for national GHG inventories. Member States are encouraged to apply Tier 3 methodology, in accordance with the 2006 IPCC guidelines for national GHG inventories. Part 4 Inventory indicators Indicator title Indicator TRANSFORMATION B0 Specific CO2 emissions of public and auto-producer power plants, t/TJ CO2 emissions from public and auto-producer thermal power stations, kt divided by all products \u2014 output by public and auto-producer thermal power stations, PJ TRANSFORMATION E0 Specific CO2 emissions of auto-producer plants t/TJ CO2 emissions from auto-producers, kt divided by All products output by auto-producer thermal power stations, PJ INDUSTRY A1.1 Total CO2 intensity \u2014 iron and steel industry, t/million euro Total CO2 emissions from iron and steel, kt divided by gross value added \u2014 iron and steel industry INDUSTRY A1.2 Energy-related CO2 intensity \u2014 chemical industry, t/million euro Energy-related CO2 emissions chemical industries, kt divided by gross value added \u2014 chemical industry INDUSTRY A1.3 Energy-related CO2 intensity \u2014 glass, pottery and building materials industry, t/million euro Energy-related CO2 emissions glass, pottery and building materials, kt divided by gross value added \u2014 glass, pottery and buildings material industry INDUSTRY A1.4 Energy-related CO2 intensity \u2014 food, drink and tobacco industry, t/million euro Energy-related CO2 emissions from food, drink and tobacco industry, kt divided by gross value-added \u2014 food, drink and tobacco industry, million euro (EC95) INDUSTRY A1.5 Energy-related CO2 intensity \u2014 paper and printing industry, t/million euro Energy-related CO2 emissions paper and printing, kt \u2014 Gross value-added \u2014 paper and printing industry, million euro (EC95) HOUSEHOLDS A0 Specific CO2 emissions of households for space heating, t/m2 CO2 emissions of households for space heating divided by surface area of permanently occupied dwellings, million m2 SERVICES B0 Specific CO2 emissions of commercial and institutional sector for space heating, kg/m2 CO2 emissions from space heating in commercial and institutional, kt divided by Surface area of services buildings, million m2 TRANSPORT B0 Specific diesel related CO2 emissions of passenger cars, g/100 km TRANSPORT B0 Specific petrol related CO2 emissions of passenger cars, g/100 km ANNEX VI POLICIES AND MEASURES INFORMATION IN THE AREA OF GHG EMISSIONS Information to be included in the reports referred to in Article 18: (a) a description of their national system for reporting on policies and measures, or groups of measures, and for reporting on projections of anthropogenic GHG emissions by sources and removals by sinks pursuant to Article 39(1) or information on any changes made to that system where such a description has already been provided; (b) updates relevant to their long-term strategies referred to in Article 15 and progress in implementing those strategies; (c) information on national policies and measures, or groups of measures, and on implementation of Union policies and measures, or groups of measures, that limit or reduce GHG emissions by sources or enhance removals by sinks, presented on a sectoral basis and organised by gas or group of gases (HFCs and PFCs) listed in Part 2 of Annex V. That information shall refer to applicable and relevant national or Union policies and shall include: (i) the objective of the policy or measure and a short description of the policy or measure; (ii) the type of policy instrument; (iii) the status of implementation of the policy or measure or group of measures; (iv) indicators used to monitor and evaluate progress over time; (v) where available, quantitative estimates of the effects on emissions by sources and removals by sinks of GHGs broken down into: \u2014 the results of ex ante assessments of the effects of individual or groups of policies and measures on the mitigation of climate change. Estimates shall be provided for a sequence of four future years ending with 0 or 5 immediately following the reporting year, with a distinction between GHG emissions covered by Directive 2003/87/EC, Regulation (EU) 2018/842 and Regulation (EU) 2018/841, \u2014 the results of ex post assessments of the effects of individual or groups of policies and measures on the mitigation of climate change where available, with a distinction between GHG emissions covered by Directive 2003/87/EC, Regulation (EU) 2018/842 and Regulation (EU) 2018/841; (vi) available estimates of the projected costs and benefits of policies and measures, as well as estimates of the realised costs and benefits of policies and measures; (vii) all existing references to the assessments of the costs and effects of national policies and measures, to information in the implementation of Union policies and measures that limit or reduce GHG emissions by sources or enhance removals by sinks and to the underpinning technical reports; (viii) an assessment of the contribution of the policy or measure to the achievement of the long-term strategy referred to in Article 15; (d) information on planned additional national policies and measures, or groups of measures, envisaged with a view to limiting GHG emissions beyond their commitments under Regulation (EU) 2018/842 and Regulation (EU) 2018/841; (e) information regarding the links between the different policies and measures, or groups of measures, reported pursuant to point (c) and the way such policies and measures, or groups of measures, contribute to different projection scenarios. ANNEX VII PROJECTIONS INFORMATION IN THE AREA OF GHG EMISSIONS Information to be included in the reports referred to in Article 18: (a) projections without measures where available, projections with measures, and, where available, projections with additional measures; (b) total GHG projections and separate estimates for the projected GHG emissions for the emission sources covered by Directive 2003/87/EC and by Regulation (EU) 2018/842 and the projected emissions by sources and removals by sinks under the Regulation (EU) 2018/841; (c) the impact of policies and measures identified pursuant to point (a) of Article 18(1). Where such policies and measures are not included, this shall be clearly stated and explained; (d) results of the sensitivity analysis performed for the projections and information on the models and parameters used; (e) all relevant references to the assessment and the technical reports that underpin the projections referred to in Article 18(4). ANNEX VIII INFORMATION ON NATIONAL ADAPTATION ACTIONS, FINANCIAL AND TECHNOLOGY SUPPORT PROVIDED TO DEVELOPING COUNTRIES AND AUCTIONING REVENUES Part 1 Reporting on adaptation actions Information to be included in the reports referred to in Article 19(1): (a) the main goals, objectives and institutional framework for adaptation; (b) climate change projections, including weather extremes, climate-change impacts, assessment of climate vulnerability and risks and key climate hazards; (c) adaptive capacity; (d) adaptation plans and strategies; (e) monitoring and evaluation framework; (f) progress made in implementation, including good practices and changes to governance. Part 2 Reporting on support provided to developing countries Information to be included in the reports referred to in Article 19(3): (a) information on financial support committed and provided to developing countries for the year X-1, including: (i) quantitative information on public and mobilised financial resources by the Member State. The information on financial flows is to be based on the so-called \u2018Rio markers\u2019 for climate change mitigation-related support and climate change adaptation-related support and other tracking systems introduced by the OECD Development Assistance Committee; (ii) qualitative methodological information explaining the method used to calculate the quantitative information, including an explanation of methodology for quantifying their data, and, where relevant, other information on the definitions and methodologies used to determine any figures, in particular for information reported on mobilised financial flows; (iii) available information on activities by the Member State related to public-funded technology transfer projects and capacity-building projects for developing countries under the UNFCCC, including whether the technology transferred or capacity-building project was used for mitigating or adapting to the effects of climate change, the recipient country, where possible the amount of support provided, and the type of technology transferred or capacity-building project; (b) available information for the year X and subsequent years on the planned provision of support, including information on planned activities related to public-funded technology transfer projects or capacity building projects for developing countries under the UNFCCC and on technologies to be transferred and capacity-building projects, including whether the technology transferred or capacity-building project is intended for mitigating or adapting to the effects of climate change, the recipient country, where possible the amount of support to be provided, and the type of technology transferred or capacity-building project. Part 3 Reporting on auctioning revenues Information to be included in the reports referred to in Article 19(2): (a) information on the use of revenues during the year X-1 generated by the Member State by auctioning allowances pursuant to Article 10(1) of Directive 2003/87/EC, including information on such revenue that has been used for one or more of the purposes specified in Article 10(3) of that Directive, or the equivalent in financial value of that revenue, and the actions taken pursuant to that article; (b) information on the use, as determined by the Member State, of all revenue generated by the Member State by auctioning aviation allowances pursuant to Article 3d(1) or (2) of Directive 2003/87/EC, which shall be provided in accordance with Article 3d(4) of that Directive; Auctioning revenues not disbursed at the time a Member State submits a report to the Commission pursuant to Article 19(2) shall be quantified and reported in reports for subsequent years. ANNEX IX ADDITIONAL REPORTING OBLIGATIONS Part 1 Additional reporting obligations in the area of renewable energy The following additional information shall, unless otherwise stated, be included pursuant to point (c) of Article 20: (a) the functioning of the system of guarantees of origin for electricity, gas and heating and cooling from renewable sources, the levels of issuance and cancellation of guarantees of origin and the resulting annual national renewable energy consumption, as well as the measures taken to ensure the reliability and protection against fraud of the system; (b) amounts of biofuels, biogas renewable transport fuels of non-biological origin, recycled carbon fuels and renewable electricity consumed in the transport sector and, where relevant, their greenhouse saving performance, distinguishing between fuels produced from different types of food and feed crops and each type of feedstock listed in Annex IX to Directive (EU) 2018/2001; (c) developments in the availability, origin and use of biomass resources for energy purposes; (d) changes in commodity prices and land use within the Member State associated with its increased use of biomass and other forms of energy from renewable sources; (e) the estimated excess production of energy from renewable sources which could be transferred to other Member States so that these comply with Article 3(3) of Directive (EU) 2018/2001 and achieve the national contributions and trajectories referred to in point (a)(2) of Article 4 of this Regulation; (f) where applicable, the estimated demand for energy from renewable sources to be satisfied by means other than domestic production until 2030, including imported biomass feedstock; (g) the technological development and deployment of biofuels made from feedstocks listed in Annex IX to Directive (EU) 2018/2001; (h) where available, the estimated impact of the production or use of biofuels, bioliquids and biomass fuels on biodiversity, water resources, water availability and quality, soils and air quality within the Member State; (i) observed cases of fraud in the chain of custody of biofuels, bioliquids and biomass fuels; (j) information on how the share of biodegradable waste in waste used for producing energy has been estimated, and what steps have been taken to improve and verify such estimates; (k) electricity and heat generation from renewable energy in buildings, including disaggregated data on energy produced, consumed and injected into the grid by solar photovoltaic systems, solar thermal systems, biomass, heatpumps, geothermal systems, as well as all other decentralised renewables systems; (l) where applicable, the share of renewable energy in district heating, as well as the renewable energy produced by cities and renewable energy communities; (m) primary supply of solid biomass (in 1 000 m3, except with regard to point (1)(b)(iii), which will be provided in tonnes) (1) Forest biomass used for energy production (domestic production and import) (a) Primary biomass from forest used directly for energy production (i) Where available, branches and tree tops (reporting is voluntary) (ii) Where applicable, stumps (reporting is voluntary) (iii) Round wood (split into industrial roundwood and fuelwood) (b) Where applicable, forest-based industry co-products used directly for energy (i) Where applicable, bark (ii) Chips, sawdust and other wood particles (iii) Where applicable, black liquor and crude tall oil (c) Where available, post-consumer wood used directly for energy production (d) Processed wood-based fuel, produced from feedstocks not accounted under point (1)(a), (b) or (c): (i) Where applicable, wood charcoal (ii) Wood pellets and wood briquettes (2) Where available, agricultural biomass used for energy production (domestic production, import and export) (a) Energy crops for electricity or heat (including short rotation coppice) (b) Agricultural crop residues for electricity or heat (3) Where available, organic waste biomass for energy production (domestic production, import and export) (a) Organic fraction of industrial waste (b) Organic fraction of municipal waste (c) Waste sludges (n) final energy consumption of solid biomass (amount of solid biomass used for energy production in the following sectors): (1) Energy sector (a) Electricity (b) Combined heat and power (c) Heat (2) Industry sector internal (consumed and autoproduced electricity, CHP and heat) (3) Direct final consumption residential (4) Other Part 2 Additional reporting obligations in the area of energy efficiency In the area of energy efficiency, the following additional information shall be included pursuant to point (c) of Article 21: (a) major legislative and non-legislative policies, measures, financing measures and programmes implemented in year X-2 and X-1 (with X as the year when the report is due) to achieve their objectives referred to in point (b) of Article 4 which promote energy service markets, improve the energy performance of buildings, measures to utilise energy efficiency potentials of gas and electricity infrastructure and heating and cooling, improve information and qualification, other measures to promote energy efficiency; (b) the cumulative amount of energy savings achieved through Article 7 of Directive 2012/27/EU in years X-3 and X-2; (c) the amount of savings achieved by policy measures aimed at alleviation of energy poverty in line with Article 7(11) of Directive 2012/27/EU; (d) where applicable, the amount of savings achieved in accordance with point (c) of Article 7(4) of Directive 2012/27/EU; (e) progress in each sector and reasons why energy consumption remained stable or was growing in year X-3 and X-2 in final energy consumption sectors; (f) total building floor area of the buildings with a total useful floor area over 250 m2 owned and occupied by the Member States' central government that, on 1 January in year X-2 and X-1, which did not meet the energy performance requirements referred to in Article 5(1) of Directive 2012/27/EU; (g) total building floor area of heated and/or cooled buildings owned and occupied by the Member States' central government that was renovated in year X-3 and X-2 referred to in Article 5(1) of the Directive 2012/27/EU or the amount of energy savings in eligible buildings owned and occupied by their central government as referred to in Article 5(6) of Directive 2012/27/EU; (h) number of energy audits carried out in in year X-3 and X-2. In addition, the total estimated number of large companies in their territory to which Article 8(4) of Directive 2012/27/EU is applicable and the number of energy audits carried out in those enterprises in the year X-3 and X-2; (i) applied national primary energy factor for electricity and a justification if this is different from the default coefficient referred to in footnote (3) of Annex IV to Directive 2012/27/EU; (j) number and floor area of new and renovated nearly zero-energy buildings in year X-2 and X-1, as provided in Article 9 of the Directive 2010/31/EU, where necessary based on statistical sampling; (k) the internet link to the website where the list or the interface of energy services providers referred to in point (c) of Article 18(1) of Directive 2012/27/EU can be accessible. ANNEX X UNION BIOENERGY SUSTAINABILITY REPORT The EU bioenergy sustainability report on energy from biomass to be adopted biennially by the Commission together with the State of the Energy Union report pursuant to point (d) of Article 35(2), shall contain as a minimum the following information: (a) the relative environmental benefits and costs of different biofuels, bioliquids and biomass fuels, the effects of the Union's import policies thereon, the security of supply implications and the ways of achieving a balanced approach between domestic production and imports; (b) the impact of the production and use of biomass on sustainability in the Union and in third countries, including impacts on biodiversity; (c) data and analysis of current and projected sustainable biomass availability and demand, including the impact of increased demand for biomass on biomass using sectors; (d) the technological development and deployment of biofuels made from feedstocks listed in Annex IX to Directive (EU) 2018/2001, and an assessment of the feedstock availability and resource competition taking into account the principles of the circular economy and the waste hierarchy established in Directive 2008/98/EC; (e) information on, and analysis of, the available scientific research results regarding indirect land-use change in relation to all production pathways, accompanied by an assessment of whether the range of uncertainty identified in the analysis underlying the estimations of indirect land-use change emissions may be narrowed and the possible impact of Union policies, such as environment, climate and agricultural policies, may be factored in; (f) in respect of both third countries and Member States that are a significant source of biofuels, bioliquids and biomass fuels consumed within the Union, on national measures taken to respect the sustainability criteria and GHG saving criteria set out in Article 29(2) to (7) and (10), of Directive (EU) 2018/2001, for soil, water and air protection; and (g) aggregated information from the database referred in Article 28(2) of Directive (EU) 2018/2001. In reporting on GHG emission savings from the use of biomass, the Commission shall use the amounts reported by Member States in accordance with point (b) of Part 1 of Annex IX to this Regulation, including the provisional mean values of the estimated indirect land-use change emissions and the associated range derived from the sensitivity analysis as set out in Annex VIII to Directive (EU) 2018/2001. The Commission shall make data on the provisional mean values of the estimated indirect land-use change emissions and the associated range derived from the sensitivity analysis publicly available. In addition, the Commission shall evaluate whether and how the estimate for direct emission savings would change if co-products were accounted for using the substitution approach ANNEX XI VOLUNTARY SCHEMES IN RESPECT OF WHICH THE COMMISSION HAS ADOPTED A DECISION PURSUANT TO ARTICLE 30(4) OF DIRECTIVE (EU) 2018/2001 The report on voluntary schemes in respect of which the Commission has adopted a decision pursuant to Article 30(4) of Directive (EU) 2018/2001, to be adopted biennially by the Commission together with the State of the Energy Union report pursuant to point (e) of Article 35(2) of this Regulation, shall contain the Commission's assessment of, as a minimum, the following: (a) the independence, modality and frequency of audits, both in relation to what is stated on those aspects in the scheme documentation, at the time the scheme concerned was approved by the Commission, and in relation to industry best practices; (b) the availability of, and experience and transparency in the application of, methods for identifying and dealing with non-compliance, with particular regard to dealing with situations or allegations of serious wrongdoing on the part of members of the scheme; (c) transparency, particularly in relation to the accessibility of the scheme, the availability of translations in the applicable languages of the countries and regions from which raw materials originate, the accessibility of a list of certified operators and relevant certificates, and the accessibility of auditor reports; (d) stakeholder involvement, particularly as regards the consultation of indigenous and local communities prior to decision making during the drafting and reviewing of the scheme as well as during audits and the response to their contributions; (e) the overall robustness of the scheme, particularly in light of rules on the accreditation, qualification and independence of auditors and relevant scheme bodies; (f) where available, market updates of the scheme, the amount of feedstocks and biofuels certified, by country of origin and type, the number of participants; (g) the ease and effectiveness of implementing a system that tracks the proofs of conformity with the sustainability criteria that the scheme gives to its member(s), such a system intended to serve as a means of preventing fraudulent activity with a view, in particular, to the detection, treatment and follow-up of suspected fraud and other irregularities and where appropriate, number of cases of fraud or irregularities detected; (h) options for entities to be authorised to recognise and monitor certification bodies; (i) criteria for the recognition or accreditation of certification bodies; (j) rules on how the monitoring of the certification bodies is to be conducted; (k) ways to facilitate or improve the promotion of best practices. ANNEX XII NATIONAL INVENTORY SYSTEMS Information referred to in Article 37 includes the following: (a) data and methods reported for activities and installations under Directive 2003/87/EC for the purpose of preparing national GHG inventories in order to ensure consistency of the reported GHG emissions under the EU ETS and in the national GHG inventories; (b) data collected through the reporting systems on fluorinated gases in the relevant sectors established pursuant to Article 20 of Regulation (EU) No 517/2014 for the purpose of preparing national GHG inventories; (c) emissions, underlying data and methodologies reported by facilities under Regulation (EC) No 166/2006 for the purpose of preparing national GHG inventories; (d) data reported under Regulation (EC) No 1099/2008; (e) data collected via the geographical tracking of land areas in the context of existing Union and Member State programmes and surveys, including the LUCAS Land Use Cover Area frame Survey and the Copernicus Programme. ANNEX XIII CORRELATION TABLE Regulation (EU) No 525/2013 This Regulation Article 1 Article 1(1) Article 2 \u2014 Article 3 \u2014 Article 4 Article 15 Article 5 Article 37(1), (2) and(6); Annex XII Article 6 Article 37(3) and (7) Article 7 Article 26(3), (4), (6) and (7); Annex V Article 8 Article 26(2) and (7) Article 9 Article 37(4) and (5) Article 10 Article 40 Article 11 \u2014 Article 12 Article 39 Article 13 Article 18(1)(a) and Article 18(3) and (4); Annex VI Article 14 Article 18(1)(b) and Article (2), (3) and (4); Annex VII Article 15 Article 19(1); Annex VIII, Part 1 Article 16 Article 19(3) and Annex VIII, Part 2 Article 17 Article 19(2), (4) and (5); Annex VIII, Part 3 Article 18 the second subparagraph of Article 17(2) Article 19 \u2014 Article 20 \u2014 Article 21 Article 29(1)(c) and Article 29(5) and (7) Article 22 \u2014 Article 23 Article 41(1)(d), (e), (f), (g) and (h) Article 24 Article 42 Article 25 \u2014 Article 26 Article 44(1)(a) and Article 44(2), (3) and (6) Article 27 \u2014 Article 28 Article 57 Article 29 \u2014", "summary": "Governance of the energy union Governance of the energy union SUMMARY OF: Regulation (EU) 2018/1999 on the governance of the energy union and climate action WHAT IS THE AIM OF THE REGULATION? It aims to ensure that the European Union\u2019s (EU) energy union strategy is implemented in a coordinated and coherent manner across its five dimensions. More broadly, it also aims to ensure that the EU achieves its objectives, in particular the targets of the 2030 policy framework for climate and energy and of the Paris Agreement on climate change. KEY POINTS The energy union strategy has five dimensions: decarbonisation, energy efficiency, energy security, the internal energy market, research, innovation and competitiveness. The regulation has a number of key features. It requires EU Member States: to produce national integrated energy and climate plans for 2021 to 2030 by 31 December 2019, and subsequently by 1 January 2029 and every ten years thereafter;to prepare long-term low-emission strategies with a 50-year perspective and report them to the European Commission, in view of contributing to broader sustainable development goals and the long-term goal set by the Paris Agreement;to produce biennial progress reports on the implementation of the plans, from 15 March 2023 onwards, to track progress across the five dimensions of the energy union. It establishes a repeated consultation process between the Commission and Member States and fosters regional cooperation between Member States, especially before the plans are finalised, and then every 10 years for the following 10-year periods. For 2021\u20132030, the plans need to be updated by 30 June 2024. It requires the Commission to monitor and assess Member States\u2019 progress towards the targets, objectives and contributions set in their national plans. It sets out the requirements for national and EU inventory systems for greenhouse gas emissions, policies, measures and projections. Amending legislation Regulation (EU) 2021/1119, known as the European climate law, amends Regulation (EU) 2018/1999. It sets a binding EU target of a net domestic reduction in greenhouse gas emissions by at least 55% (compared with 1990 levels) by 2030, and undertakes to set a climate target for 2040 within 6 months of the first global stocktaking under the Paris Agreement. Delegated acts The Commission has the power to adopt delegated acts to adapt the national energy and climate plans template to amendments to the EU\u2019s energy and climate policy framework that are directly and specifically related to the EU\u2019s contributions under the United Nations Framework Convention on Climate Change and the Paris Agreement. It also has the power to adopt delegated acts to take account of changes in the global warming potentials and internationally agreed inventory guidelines, to set substantive requirements for the EU inventory system and to set up the registries. Delegated Regulation (EU) 2020/1044 supplements Regulation (EU) 2018/1999 with regard to values for global warming potentials and the greenhouse gas inventory guidelines, and with regard to the EU\u2019s inventory system: it repeals Delegated Regulation (EU) No 666/2014 from 1 January 2021;it applies to reports submitted by Member States from 2021 onwards;Member States and the Commission will use the global warming potentials listed in its Annex I for the purpose of determining and reporting greenhouse gas inventories data. Implementing acts The Commission has adopted two implementing acts: Implementing Regulation (EU) 2020/1208 on the structure, format, submission processes and review of information that Member States report in line with Regulation (EU) 2018/1999; and Implementing Regulation (EU) 2020/1294 on the EU\u2019s renewable energy financing mechanism. Repeal The regulation repeals Regulation (EU) No 525/2013 on the monitoring and reporting mechanism for greenhouse gas emissions. FROM WHEN DOES THE REGULATION APPLY? It has applied since 24 December 2018. BACKGROUND For further information, see: Energy union (European Commission). MAIN DOCUMENT Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, pp. 1\u201377). Successive amendments to Regulation (EU) 2018/1999 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) 2020/1294 of 15 September 2020 on the Union renewable energy financing mechanism (OJ L 303, 17.9.2020, pp. 1\u201317). Commission Implementing Regulation (EU) 2020/1208 of 7 August 2020 on structure, format, submission processes and review of information reported by Member States pursuant to Regulation (EU) 2018/1999 of the European Parliament and of the Council and repealing Commission Implementing Regulation (EU) No 749/2014 (OJ L 278, 26.8.2020, pp. 1\u2013132). Commission Delegated Regulation (EU) 2020/1044 of 8 May 2020 supplementing Regulation (EU) 2018/1999 of the European Parliament and of the Council with regard to values for global warming potentials and the inventory guidelines and with regard to the Union inventory system and repealing Commission Delegated Regulation (EU) No 666/2014 (OJ L 230, 17.7.2020, pp. 1\u20136). Council Decision (EU) 2016/1841 of 5 October 2016 on the conclusion, on behalf of the European Union, of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (OJ L 282, 19.10.2016, pp. 1\u20133). Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: A policy framework for climate and energy in the period from 2020 to 2030 (COM(2014) 15 final/2, 28.1.2014). last update 18.12.2021"}
{"article": "25.6.2019 EN Official Journal of the European Union L 169/45 REGULATION (EU) 2019/1021 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on persistent organic pollutants (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Regulation (EC) No 850/2004 of the European Parliament and of the Council (3) has been substantially amended several times. Since it is necessary to make further amendments, that Regulation should be recast in the interests of clarity. (2) The Union is seriously concerned by the continuous release of persistent organic pollutants (\u2018POPs\u2019) into the environment. Those chemical substances are transported across international boundaries, far from their sources, and they persist in the environment, bioaccumulate through the food web, and pose a risk to human health and the environment. Therefore, further measures need to be taken in order to protect human health and the environment against those pollutants. (3) In view of its responsibilities for the protection of the environment, the Union approved on 19 February 2004 the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (4) (\u2018the Protocol\u2019) and approved on 14 October 2004 the Stockholm Convention on Persistent Organic Pollutants (5) (\u2018the Convention\u2019). (4) In order to ensure coherent and effective implementation of the Union's obligations under the Protocol and the Convention, it is necessary to establish a common legal framework within which to take measures designed, in particular, to eliminate the manufacturing, placing on the market and use of intentionally manufactured POPs. Furthermore, POPs' characteristics should be taken into consideration in the framework of the relevant Union assessment and authorisation schemes. (5) When implementing the provisions of the Convention at Union level, it is necessary to ensure coordination and coherence with the provisions of the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade, which was approved by the Union on 19 December 2002 (6), and with the provisions of the Basel Convention on the control of transboundary movements of hazardous wastes and their disposal, which was approved by the Union on 1 February 1993 (7) and of the Minamata Convention on Mercury, which was approved by the Union on 11 May 2017 (8). This coordination and coherence should also be maintained when participating in the implementation and further development of the Strategic Approach to International Chemicals Management (SAICM), adopted by the First International Conference on Chemicals Management in Dubai on 6 February 2006, and the Sound Management of Chemicals and Waste Beyond 2020 within the United Nations framework. (6) Moreover, considering that the provisions of this Regulation are underpinned by the precautionary principle as set forth in the Treaty on the Functioning of the European Union (TFEU), and mindful of the precautionary approach to environmental protection as set forth in Principle 15 of the Rio Declaration on Environment and Development, and in view of the aim of the elimination, where feasible, of the release of POPs into the environment, it is appropriate in certain cases to provide for control measures stricter than those under the Protocol and the Convention. (7) In the Union, the placing on the market and use of most of the POPs listed in the Protocol or the Convention have already been phased out as a result of the prohibitions laid down in, inter alia, Regulations (EC) No 1907/2006 (9), (EC) No 1107/2009 (10) and (EU) No 528/2012 (11) of the European Parliament and of the Council. However, in order to fulfil the Union's obligations under the Protocol and the Convention, and to minimise the release of POPs, it is necessary and appropriate also to prohibit the manufacturing of those substances and to restrict exemptions to a minimum so that exemptions only apply where a substance fulfils an essential function in a specific application. (8) For reasons of clarity and consistency with other relevant Union legislative acts, certain definitions should be specified, and terminology should be aligned with that used in Regulation (EC) No 1907/2006 and Directive 2008/98/EC of the European Parliament and of the Council (12). (9) Exports of substances covered by the Convention are regulated by Regulation (EU) No 649/2012 of the European Parliament and of the Council (13) and therefore need not be further addressed in this Regulation. (10) Obsolete or carelessly managed stockpiles of POPs may seriously endanger the environment and human health through, for instance, contamination of soil and ground water. It is appropriate, therefore, to lay down stricter rules concerning the management of such stockpiles compared to those laid down in the Convention. Stockpiles of prohibited substances should be treated as waste, while stockpiles of substances the manufacturing or use of which is still allowed should be notified to the authorities and properly supervised. In particular, existing stockpiles which consist of or contain banned POPs should be managed as waste as soon as possible. If other substances are banned in the future, their stocks should also be destroyed without delay, and no new stockpiles should be built up. (11) In line with the Protocol and the Convention, releases of POPs which are unintentional by-products of industrial processes should be identified and reduced as soon as possible, with the ultimate aim of elimination, where feasible. Appropriate national action plans, covering all sources and measures, including those provided for under existing Union legislation, should be developed, updated and implemented, as appropriate, as soon as possible, to reduce such releases continuously and cost-effectively. To this end, appropriate tools should be developed in the framework of the Convention. (12) The Guidelines on Best Available Techniques and Provisional Guidance on Best Environmental Practices Relevant to Article 5 and Annex C of the Stockholm Convention on Persistent Organic Pollutants, which were adopted pursuant to the Stockholm Convention, should be used when considering proposals to construct new facilities or to significantly modify existing facilities using processes that release chemicals listed in Annex III to this Regulation. (13) Appropriate programmes and mechanisms should be established or maintained, as appropriate, to provide adequate monitoring data on the presence of substances listed in Part A of Annex III in the environment. However, it is necessary to ensure that appropriate tools are available and can be used under economically and technically viable conditions. (14) Under the Convention, the POP content in waste is to be destroyed or irreversibly transformed into substances that do not exhibit similar characteristics, unless other operations are environmentally preferable. In order for the Union to comply with its obligations under the Convention, it is necessary to lay down specific rules as regards those substances. To ensure a high level of protection, common concentration limits for the substances in waste should be established, monitored and enforced. (15) Concerning polybrominated diphenyl ethers (PBDEs) listed in this Regulation, including decaBDE, the concentration limit for the sum of those substances in waste is set at 1 000 mg/kg. Considering that scientific and technical progress are rapidly evolving, the Commission should review that concentration limit and, where appropriate, adopt a legislative proposal to lower that value to 500 mg/kg. The Commission should act as quickly as possible and, in any event, not later than 16 July 2021. (16) It is important to identify and separate waste consisting of, containing or contaminated by POPs at source in order to minimise the spread of those chemicals into other waste. Directive 2008/98/EC establishes Union rules on the management of hazardous waste, obliging Member States to take the necessary measures to require that establishments and undertakings which dispose of, recover, collect or transport hazardous waste, do not mix different categories of hazardous waste or mix hazardous waste with non-hazardous waste. (17) In order to promote the traceability of waste containing POPs and ensure control, the provisions of the record keeping system established in accordance with Article 17 of Directive 2008/98/EC should apply also to such waste containing POPs which is not defined as hazardous waste according to Commission Decision 2014/955/EU (14). (18) There is a need to ensure the effective coordination and management of technical and administrative aspects of this Regulation at Union level. The European Chemicals Agency (\u2018the Agency\u2019), established by Regulation (EC) No 1907/2006, has the competence and experience in implementing Union legislation on chemicals and international agreements on chemicals. The Member States and the Agency should therefore carry out tasks with regard to the administrative, technical and scientific aspects of the implementation of this Regulation and the exchange of information. The role of the Agency should include the preparation and examination of technical dossiers, including stakeholder consultations, and the drawing up of opinions that should be used by the Commission in considering whether to come forward with a proposal for listing a substance as a POP in the Convention or the Protocol. In addition, the Commission, the Member States and the Agency should cooperate in order to implement the Union's international obligations under the Convention effectively. (19) The Convention provides that each Party is to draw up, update and endeavour to implement, as appropriate, a plan for the implementation of its obligations under the Convention. Member States should provide opportunities for public participation in drawing up, implementing and updating their implementation plans. Since the Union and the Member States share competence in that regard, implementation plans should be drawn up and updated both at national and Union level. Cooperation and exchange of information, including on sites contaminated by POPs, between the Commission, the Agency and the authorities of the Member States should be promoted. (20) Substances listed in Part A of Annex I or Part A of Annex II to this Regulation should only be allowed to be manufactured and used as closed-system site-limited intermediates if an annotation to that effect is expressly entered in the relevant Annex and if the manufacturer demonstrates to the Member State concerned that the substance is only manufactured and used under strictly controlled conditions. (21) In accordance with the Convention and the Protocol, information on POPs should be provided to other Parties to those Agreements. The exchange of information with third countries not party to those Agreements should also be promoted. (22) Since public awareness of the hazards that POPs pose to the health of present and future generations, as well as to the environment, particularly in developing countries, is often lacking, wide-scale information is needed to increase the level of caution and public understanding of the rationale for restrictions and bans. In accordance with the Convention, public awareness programmes on those substances as regards their health and environmental effects, especially for the most vulnerable groups, as well as training of workers, scientists, educators, technical and managerial personnel should be promoted and facilitated, as appropriate. The Union should ensure access to information, without prejudice to Regulations (EC) No 1049/2001 (15) and (EC) No 1367/2006 (16) of the European Parliament and of the Council, and to Directive 2003/4/EC of the European Parliament and of the Council (17). (23) In order to promote the development of a comprehensive chemical exposure and toxicity knowledge base, in line with the General Union Environment Action Programme to 2020 \u2018Living well, within the limits of our planet\u2019 (\u2018the 7th EAP\u2019) (18), the Commission has established the Information Platform for Chemical Monitoring. The use of that platform should be encouraged as a means for Member States to comply with their obligations to report chemical occurrence data and to simplify and reduce their reporting obligations. (24) Upon request, and within available resources, the Commission, the Agency and the Member States should cooperate in providing appropriate and timely technical assistance designed especially to strengthen the capacity of developing countries and countries with economies in transition to implement the Convention. Technical assistance should include the development and implementation of suitable alternative products, methods and strategies, under the Convention, to ensure that POPs only continue to be used when locally safe, effective and affordable alternatives are not available to the country in question. (25) There should be regular evaluation of the effectiveness of measures taken to reduce releases of POPs. To that end, Member States should report regularly, in standardised form, to the Agency, in particular as regards release inventories, notified stockpiles and the manufacturing and placing on the market of restricted substances. (26) To address the need for information on implementation and compliance, an alternative system of collecting and making information available should be introduced, taking into account the results of the Commission Report on Actions to Streamline Environmental Reporting and its related Fitness Check. In particular, Member States should make all relevant data accessible. That should ensure that the administrative burden on all entities remains as limited as possible. It requires that active dissemination at national level be done in accordance with Directives 2003/4/EC and 2007/2/EC of the European Parliament and of the Council (19), to ensure the appropriate infrastructure for public access, reporting and data-sharing between public authorities. In that context, Member States and the Agency should base the specifications for spatial data on the implementing acts adopted under Directive 2007/2/EC. (27) The Convention and the Protocol provide that Parties thereto may propose additional substances for international action and consequently additional substances may be listed under those Agreements. In such cases, this Regulation should be amended accordingly. (28) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending this Regulation by permitting, where appropriate, the manufacture and use of a substance listed in Part A of Annex I or Part A of Annex II to this Regulation as a closed-system site-limited intermediate and amending the deadlines in an annotation entered in the relevant Annex for that purpose, of amending Annex III to this Regulation in order to move a substance from Part B to Part A thereof and of amending Annexes I, II and III to this Regulation in order to adapt them to any change to the list of substances set out in the Annexes to the Convention or the Protocol, as well as to modify existing entries or provisions in Annexes I and II to this Regulation in order to adapt them to scientific and technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (20). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts should systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (29) When Annexes to this Regulation are amended to implement any listing of an additional, intentionally produced POP in the Protocol or in the Convention, the listing should be included in Annex II, instead of Annex I, only in exceptional cases and when duly justified. (30) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt measures concerning waste management and the minimum information to be provided by Member States in monitoring the implementation of this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (21). (31) In order to ensure transparency, impartiality and consistency at the level of enforcement activities, Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive, since non-compliance can result in damage to human health and to the environment. To ensure consistent and effective enforcement of this Regulation, the Member States should coordinate relevant activities and exchange information in the Forum for Exchange of Information on Enforcement established under Regulation (EC) No 1907/2006. Information on infringements of the provisions of this Regulation should be made public, where appropriate. (32) For the purposes of this Regulation other than matters relating to waste, the Commission should be assisted by the committee established by Regulation (EC) No 1907/2006, with a view to ensuring a consistent approach concerning chemicals legislation of the Union. (33) For the purposes of this Regulation, on matters relating to waste, the Commission should be assisted by the committee established by Directive 2008/98/EC with a view to ensuring a consistent approach concerning waste legislation of the Union. (34) Since the objective of this Regulation, namely to protect the environment and human health from POPs, cannot be sufficiently achieved by the Member States, owing to the transboundary effects of those pollutants, but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Objective and subject matter Taking into account, in particular, the precautionary principle, the objective of this Regulation is to protect human health and the environment from POPs by prohibiting, phasing out as soon as possible, or restricting the manufacturing, placing on the market and use of substances subject to the Stockholm Convention on Persistent Organic Pollutants, hereinafter \u2018the Convention\u2019, or the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants, hereinafter \u2018the Protocol\u2019, by minimising, with a view to eliminating where feasible as soon as possible, releases of such substances, and by establishing provisions regarding waste consisting of, containing or contaminated by any of those substances. Where appropriate, Member States may apply stricter requirements than those laid down in this Regulation, in accordance with the TFEU. Article 2 Definitions For the purposes of this Regulation: (1) \u2018placing on the market\u2019 means placing on the market as defined in point 12 of Article 3 of Regulation (EC) No 1907/2006; (2) \u2018article\u2019 means article as defined in point 3 of Article 3 of Regulation (EC) No 1907/2006; (3) \u2018substance\u2019 means substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006; (4) \u2018mixture\u2019 means mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006; (5) \u2018manufacturing\u2019 means manufacturing as defined in point 8 of Article 3 of Regulation (EC) No 1907/2006; (6) \u2018use\u2019 means use as defined in point 24 of Article 3 of Regulation (EC) No 1907/2006; (7) \u2018import\u2019 means import as defined in point 10 of Article 3 of Regulation (EC) No 1907/2006; (8) \u2018waste\u2019 means waste as defined in point 1 of Article 3 of Directive 2008/98/EC; (9) \u2018disposal\u2019 means disposal as defined in point 19 of Article 3 of Directive 2008/98/EC; (10) \u2018recovery\u2019 means recovery as defined in point 15 of Article 3 of Directive 2008/98/EC; (11) \u2018closed-system site-limited intermediate\u2019 means a substance that is manufactured for, and consumed in or used for chemical processing in order to be transformed into another substance (\u2018synthesis\u2019) and where the manufacture of the intermediate and the synthesis of one or more other substances from that intermediate take place on the same site, by one or more legal entities, under strictly controlled conditions in that it is rigorously contained by technical means during its whole life cycle; (12) \u2018unintentional trace contaminant\u2019 means a level of a substance that is incidentally present in a minimal amount, below which the substance cannot be meaningfully used, and above the detection limit of existing detection methods to enable control and enforcement; (13) \u2018stockpile\u2019 means substances, mixtures or articles accumulated by the holder that consist of or contain any substance listed in Annex I or II. Article 3 Control of manufacturing, placing on the market and use, and the listing of substances 1. The manufacturing, placing on the market and use of substances listed in Annex I, whether on their own, in mixtures or in articles, shall be prohibited, subject to Article 4. 2. The manufacturing, placing on the market and use of substances listed in Annex II, whether on their own, in mixtures or in articles, shall be restricted, subject to Article 4. 3. Member States and the Commission shall, within the assessment and authorisation schemes for existing and new substances under the relevant Union legislation, take into consideration the criteria set out in paragraph 1 of Annex D to the Convention and take appropriate measures to control existing substances and prevent the manufacturing, placing on the market and use of new substances, which exhibit characteristics of POPs. 4. When preparing a proposal to the Council, pursuant to Article 218(9) TFEU, for the listing of a substance in accordance with the provisions of the Convention, the Commission shall be supported by the European Chemicals Agency (\u2018the Agency\u2019), established by Regulation (EC) No 1907/2006, as referred to in point (c) of Article 8(1). The competent authorities of Member States may forward proposals for listing to the Commission. In the further stages of the listing process, the Agency shall provide support to the Commission and the competent authorities of the Member States, as referred to in point (e) of Article 8(1). 5. The Commission and the Agency shall, in all stages of the process referred to in paragraphs 3 and 4, cooperate with and inform the competent authorities of the Member States. 6. Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7. Article 4 Exemptions from control measures 1. Article 3 shall not apply in the case of: (a) a substance used for laboratory-scale research or as a reference standard; (b) a substance present as an unintentional trace contaminant, as specified in the relevant entries of Annex I or II, in substances, mixtures or articles. 2. For a substance added to Annex I or II after 15 July 2019, Article 3 shall not apply for a six-month period if that substance is present in articles produced before or on the date that this Regulation becomes applicable to that substance. Article 3 shall not apply in the case of a substance present in articles already in use before or on the date that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first. Immediately upon becoming aware of articles as referred to in the first and second subparagraph, a Member State shall inform the Commission and the Agency accordingly. Whenever the Commission is so informed or otherwise learns of such articles, it shall, where appropriate, notify the Secretariat of the Convention accordingly without further delay. 3. Where a substance is listed in Part A of Annex I or in Part A of Annex II, a Member State wishing to permit, until the deadline specified in the relevant Annex, the manufacturing and use of that substance as a closed-system site-limited intermediate shall notify accordingly the Secretariat of the Convention. Such notification may be made only if the following conditions are satisfied: (a) following the request of a Member State or on the Commission's own initiative, an annotation has been entered in the relevant Annex, by means of a delegated act adopted on the basis of the fourth subparagraph; (b) the manufacturer demonstrates to the competent authority of the Member State in which the manufacturer is established that the manufacturing process will transform the substance into one or more other substances that do not exhibit the characteristics of a POP, ensuring that it is rigorously contained by technical means during its whole life cycle; (c) the manufacturer demonstrates to the competent authority of the Member State in which the manufacturer is established that the substance is a closed-system site-limited intermediate and that it is not expected that either humans or the environment will be exposed to any significant quantities of the substance during its production and use; (d) the manufacturer informs the Member State on the details of actual or estimated total manufacturing and use of the substance concerned and the nature of the closed-system site-limited process, specifying the amount of any non-transformed and unintentional trace contamination by any POP starting material in the final substance, mixture or article. Within one month of submission of the notification to the Secretariat of the Convention, the Member State shall communicate the notification to the other Member States, to the Commission and the Agency, and shall give details of actual or estimated total manufacturing and use of the substance concerned and the nature of the closed-system site-limited process, specifying the amount of any non-transformed and unintentional trace contamination by any POP starting material in the final substance, mixture or article. The Commission is empowered to adopt delegated acts in accordance with Article 18 in order to amend Annexes I and II by entering annotations expressly to the effect that manufacturing and use, as a closed-system site-limited intermediate, of a substance listed in Part A of the relevant Annex may be permitted, and to amend the deadlines in such annotations in cases where, following a repeat notification from the Member State concerned to the Secretariat of the Convention, express or tacit consent is issued under the Convention for the continued manufacturing and use of the substance for another period. 4. Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7. Article 5 Stockpiles 1. The holder of a stockpile, which consists of or contains any substance listed in Annex I or II, for which no use is permitted, shall manage that stockpile as waste and in accordance with Article 7. 2. The holder of a stockpile greater than 50 kg, consisting of or containing any substance listed in Annex I or II, and the use of which is permitted shall provide the competent authority of the Member State in which the stockpile is established with information concerning the nature and size of that stockpile. Such information shall be provided within 12 months of the date that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first for the holder, and of relevant amendments to Annex I or II and annually thereafter until the deadline specified in Annex I or II for restricted use. The holder shall manage the stockpile in a safe, efficient and environmentally sound manner, in accordance with the thresholds and requirements laid down in Directive 2012/18/EU of the European Parliament and of the Council (22) and taking all adequate steps to ensure that the stockpile is managed in a manner that will protect human health and the environment. 3. Member States shall monitor the use and management of notified stockpiles. Article 6 Release reduction, minimisation and elimination 1. Within two years of the date of entry into force of this Regulation or Regulation (EC) No 850/2004, whichever date came first, Member States shall draw up inventories for the substances listed in Annex III released into air, water and land in accordance with their obligations under the Convention and the Protocol and shall subsequently maintain such inventories. 2. Member States shall communicate their action plans on measures to identify, characterise and minimise, with a view to eliminating where feasible as soon as possible, the total releases of substances listed in Annex III as recorded in their inventories drawn up in accordance with their obligations under the Convention, to the Commission, the Agency and to the other Member States as part of their national implementation plans, pursuant to Article 9. Such action plans shall include measures to promote the development of, and, where it is considered appropriate, shall require the use of substitute or modified substances, mixtures, articles and processes to prevent the formation and release of substances listed in Annex III. 3. Member States shall, when considering proposals to construct new facilities or to significantly modify existing facilities using processes that release chemicals listed in Annex III, give priority consideration to alternative processes, techniques or practices that have similar usefulness but which avoid the formation and release of substances listed in Annex III, without prejudice to Directive 2010/75/EU of the European Parliament and of the Council (23). Article 7 Waste management 1. Producers and holders of waste shall undertake all reasonable efforts to avoid, where feasible, contamination of this waste with substances listed in Annex IV. 2. Notwithstanding Council Directive 96/59/EC (24), waste consisting of, containing or contaminated by any substance listed in Annex IV to this Regulation shall be disposed of or recovered, without undue delay and in accordance with Part 1 of Annex V to this Regulation, in such a way as to ensure that the POP content is destroyed or irreversibly transformed so that the remaining waste and releases do not exhibit the characteristics of POPs. In carrying out such a disposal or recovery, any substance listed in Annex IV may be isolated from the waste, provided that this substance is subsequently disposed of in accordance with the first subparagraph. 3. Disposal or recovery operations that may lead to recovery, recycling, reclamation or re-use on their own of the substances listed in Annex IV shall be prohibited. 4. By way of derogation from paragraph 2: (a) waste containing or contaminated by any substance listed in Annex IV may be otherwise disposed of or recovered in accordance with the relevant Union legislation, provided that the content of the listed substances in the waste is below the concentration limits specified in Annex IV; (b) a Member State or the competent authority designated by that Member State may, in exceptional cases, allow wastes listed in Part 2 of Annex V containing or contaminated by a substance listed in Annex IV up to concentration limits specified in Part 2 of Annex V to be otherwise dealt with in accordance with a method listed in Part 2 of Annex V, provided that the following conditions are fulfilled: (i) the holder concerned has demonstrated to the satisfaction of the competent authority of the Member State concerned that decontamination of the waste in relation to substances listed in Annex IV was not feasible, and that destruction or irreversible transformation of the POP content, performed in accordance with best environmental practice or best available techniques, does not represent the environmentally preferable option and the competent authority has subsequently authorised the alternative operation; (ii) the holder concerned has provided information on the POP content of the waste to the competent authority; (iii) the operation is in accordance with relevant Union legislation and with the conditions laid down in relevant additional measures referred to in paragraph 5; (iv) the Member State concerned has informed the other Member States, the Agency and the Commission of its authorisation and the justification for it. 5. The Commission may, where appropriate, and taking into consideration technical developments and relevant international guidelines and decisions and any authorisations granted by a Member State, or by the competent authority designated by that Member State in accordance with paragraph 4 and Annex V, adopt implementing acts concerning the implementation of this Article. In particular, the Commission may specify the format of the information to be submitted by Member States in accordance with point (b)(iv) of paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(3). 6. Member States shall take the necessary measures to ensure the control and traceability, in accordance with Article 17 of Directive 2008/98/EC, of waste containing or contaminated by a substance listed in Annex IV to this Regulation. Article 8 Tasks of the Agency and the Forum 1. The Agency shall, in addition to the tasks allocated to it under Articles 9, 10, 11, 13 and 17, carry out the following tasks: (a) with the agreement of the Commission, provide the designated competent authorities of the Member States and the members of the Forum for Exchange of Information on Enforcement established by Regulation (EC) No 1907/2006 (\u2018Forum\u2019), as well as stakeholders as appropriate, with assistance and technical and scientific guidance in order to ensure the effective application of this Regulation; (b) upon request, provide the Commission with technical and scientific input and assist it in order to ensure the effective implementation of this Regulation; (c) provide technical and scientific support and input to the Commission as regards substances that may meet the criteria for listing in the Convention or the Protocol, taking into account, as appropriate, results from existing assessment schemes referred to in Article 3(3); (d) publish on its website a notice that a proposal for the listing of a substance will be prepared by the Commission, invite all interested parties to submit comments within eight weeks, and publish those comments on its website; (e) provide the Commission and the Member States with technical and scientific support in the preparation and review of the risk profile and the risk management evaluation of a substance considered under the Convention, invite all interested parties to submit comments or additional information, or both, within eight weeks and publish those comments on its website; (f) upon request, provide the Commission with technical and scientific support in implementing and further developing the Convention, in particular with respect to the POPs Review Committee; (g) compile, register, process and make available to the Commission and the competent authorities of the Member States all the information received or available pursuant to Article 4(2) and (3), point (b)(iv) of Article 7(4), Article 9(2) and Article 13(1). Where such information is non-confidential, the Agency shall make that information publicly available on its website and shall facilitate the exchange of that information with relevant information platforms such as those referred to in Article 13(2); (h) establish and maintain sections on its website for all matters relating to the implementation of this Regulation. 2. The Forum shall be used to coordinate a network of the Member States' authorities responsible for enforcement of this Regulation. The members of the Forum who are appointed by a Member State shall ensure that there is appropriate coordination between the tasks of the Forum and the work of their Member State competent authority. The Forum shall involve the enforcement authorities of Member States responsible for waste when dealing with waste-related issues. 3. The Secretariat of the Agency shall carry out the tasks allocated to the Agency under this Regulation. Article 9 Implementation plans 1. When preparing and updating their national implementation plans, Member States shall, in accordance with their national procedures, give the public early and effective opportunities to participate in this process. 2. As soon as a Member State has adopted its national implementation plan in accordance with its obligations under the Convention, it shall make it publicly available and communicate its publication to the Commission, the Agency and to the other Member States. 3. When Member States are preparing and updating their implementation plans, the Commission, supported by the Agency, and the Member States shall exchange information on the content, including information on measures taken at national level to identify and assess sites contaminated by POPs, as appropriate. 4. The Commission, supported by the Agency, shall maintain a plan for the implementation of Union obligations under the Convention and shall publish, review and update that plan, as appropriate. Article 10 Monitoring 1. The Commission, supported by the Agency, and the Member States shall establish or maintain, as appropriate, in close cooperation, appropriate programmes and mechanisms, consistent with the state of the art, for the regular provision of comparable monitoring data on the presence of substances as listed in Part A of Annex III in the environment. When establishing or maintaining such programmes and mechanisms, due account shall be taken of developments under the Protocol and the Convention. 2. The Commission shall regularly assess the possible need for the mandatory monitoring of a substance listed in Part B of Annex III. In the light of such an assessment and any data made available to it by Member States, the Commission is empowered to adopt delegated acts in accordance with Article 18 to amend Annex III in order to move, where appropriate, a substance from Part B of Annex III to Part A thereof. Article 11 Information exchange 1. The Commission, the Agency and the Member States shall facilitate and undertake the exchange within the Union and with third countries of information relevant to the reduction, minimisation or elimination, where feasible, of the manufacturing, use and release of POPs and to alternatives to those substances, specifying the risks and the economic and social costs related to such alternatives. 2. The Commission, the Agency and the Member States, as appropriate, shall promote and facilitate with regard to POPs: (a) awareness programmes, including relating to their health and environmental effects and their alternatives and on the reduction or elimination of their manufacture, use and release, especially for: (i) policy- and decision-makers; (ii) particularly vulnerable groups; (b) the provision of public information; (c) training, including workers, scientists, educators and technical and managerial personnel. 3. Without prejudice to Regulations (EC) No 1049/2001, and (EC) No 1367/2006 and Directive 2003/4/EC, information on the health and safety of humans and the environment shall not be regarded as confidential. The Commission, the Agency and the Member States that exchange information with a third country shall protect any confidential information in accordance with Union law. Article 12 Technical assistance In accordance with Articles 12 and 13 of the Convention, the Commission and the Member States shall cooperate in providing appropriate and timely technical and financial assistance to developing countries and countries with economies in transition to assist them, upon request and within available resources and taking into account their particular needs, to develop and strengthen their capacity to fully implement their obligations under the Convention. Such support may also be channelled through regional centres, as identified under the Convention, non-governmental organisations or the Agency. Article 13 Monitoring of implementation 1. Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States shall draw up and publish a report containing: (a) information on the application of this Regulation, including information on enforcement activities, infringements and penalties; (b) information compiled from the notifications received pursuant to Article 4(2) and (3), Article 5(2) and point (b)(iv) of Article 7(4); (c) information compiled from the release inventories drawn up pursuant to Article 6(1); (d) information on implementation in accordance with the national implementation plans drawn up pursuant to Article 9(2); (e) information on the presence of substances listed in Part A of Annex III in the environment, as compiled pursuant to Article 10; (f) annual monitoring and statistical data on the actual or estimated total manufacturing and placing on the market of any substance listed in Annex I or II, including relevant indicators, overview maps, reports. Member States shall update the report annually as far as new data or information is available and otherwise at least every three years. Members States shall give the Commission and the Agency access to the information contained in the reports. 2. Where a Member State shares the information referred to in point (e) of paragraph 1 with the Information Platform for Chemical Monitoring, this shall be indicated by that Member State in its report and the Member State shall be considered to have fulfilled its reporting obligations under that point. Where the information referred to in point (e) of paragraph 1 is contained in the report of a Member State provided to the Agency, the Agency shall use the Information Platform for Chemical Monitoring for compiling, storing and sharing that information. 3. Regarding the substances listed in the Convention, the Commission, supported by the Agency, shall, at the intervals determined by the Conference of the Parties of the Convention, compile a report on the basis of the information provided by the Member States to the Agency in accordance with point (f) of paragraph 1 and communicate it to the Secretariat of the Convention. 4. The Agency shall compile and publish a Union overview report on the basis of the data referred to in paragraphs 1 and 2 that is published or notified by the Member States. The Union overview report shall include, as appropriate, indicators for outputs, results and impact of this Regulation, Union overview maps and Member State reports. The Union overview report shall be updated by the Agency at least once every six months or following receipt of a request from the Commission. 5. The Commission may adopt implementing acts concerning the minimum information to be provided in accordance with paragraph 1, including the definition of relevant indicators, overview maps and reports referred to in point (f) of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(3). Article 14 Penalties Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Where Member States have not already done so before the entry into force of this Regulation, they shall notify those rules and measures to the Commission on 16 July 2020 at the latest and shall notify it, without delay, of any subsequent amendment affecting them. Article 15 Amendment of Annexes 1. The Commission is empowered to adopt delegated acts in accordance with Article 18 to amend the Annexes I, II and III to this Regulation in order to adapt them to changes to the list of substances set out in the Annexes to the Convention or the Protocol, on the basis that the Union has supported the change concerned by means of a Council decision adopted in accordance with Article 218(9) TFEU, or to modify existing entries or provisions in Annexes I and II to this Regulation in order to adapt them to scientific and technical progress. Whenever the Commission amends Annex I, II or III to this Regulation, it shall adopt a separate delegated act in respect of each substance. 2. The Commission shall keep Annexes IV and V under constant review and shall, where appropriate, make legislative proposals to amend these Annexes in order to adapt them to the changes to the list of substances set out in the Annexes to the Convention or the Protocol or to modify existing entries or provisions in the Annexes to this Regulation in order to adapt them to scientific and technical progress. Article 16 The budget of the Agency 1. For the purposes of this Regulation, the revenues of the Agency shall consist of: (a) a subsidy from the Union, entered in the general budget of the Union (Commission Section); (b) any voluntary contribution from the Member States. 2. Revenues and expenditure for activities under this Regulation shall be combined with those relating to activities under Regulation (EU) No 649/2012 and shall be reflected in the same section in the Agency's budget. The revenues of the Agency referred to in paragraph 1 shall be used for carrying out its tasks under this Regulation. Article 17 Formats and software for publication or notification of information The Agency shall, in cooperation with the Member States, specify formats and software for the publication or notification of data by Member States pursuant to this Regulation and shall make them available free of charge on its website. In relation to spatial data sets and spatial data services, Member States and the Agency shall design the formats in accordance with the requirements of Directive 2007/2/EC. Member States and other parties subject to this Regulation shall use those formats and software in their data management or data exchange with the Agency. Article 18 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 4(3), 10(2) and 15(1) shall be conferred on the Commission for a period of five years from 15 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 4(3), 10(2) and 15(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 4(3), 10(2) and 15(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 19 Competent authorities Each Member State shall designate a competent authority or authorities responsible for the administrative tasks and enforcement required by this Regulation. It shall inform the Commission of such designation at the latest three months after the entry into force of this Regulation, unless it has already done so before the entry into force of this Regulation, and shall also inform the Commission of any change of designated competent authority. Article 20 Committee procedure 1. Except in the case referred to in paragraph 2, the Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. For matters relating to waste, the Commission shall be assisted by the Committee established by Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 21 Repeal Regulation (EC) No 850/2004 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII. Article 22 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 367, 10.10.2018, p. 93. (2) Position of the European Parliament of 18 April 2019 (not yet published in the Official Journal) and decision of the Council of 13 June 2019. (3) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7). (4) OJ L 81, 19.3.2004, p. 37. (5) OJ L 209, 31.7.2006, p. 3. (6) OJ L 63, 6.3.2003, p. 29. (7) OJ L 39, 16.2.1993, p. 3. (8) OJ L 142, 2.6.2017, p. 4. (9) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). (10) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). (11) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). (12) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). (13) Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60). (14) Commission Decision 2014/955/EU of 18 December 2014 amending Decision 2000/532/EC on the list of waste pursuant to Directive 2008/98/EC of the European Parliament and of the Council (OJ L 370, 30.12.2014, p. 44). (15) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (16) Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13). (17) Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). (18) OJ L 354, 28.12.2013, p. 171. (19) Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1). (20) OJ L 123, 12.5.2016, p. 1. (21) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (22) Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1). (23) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17). (24) Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT) (OJ L 243, 24.9.1996, p. 31). ANNEX I Part A Substances listed in the Convention and in the Protocol as well as substances listed only in the Convention Substance CAS No EC No Specific exemption on intermediate use or other specification Tetrabromodiphenyl ether C12H6Br4O 40088-47-9 and others 254-787-2 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of Tetrabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentration of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed: electrical and electronic equipment within the scope of Directive 2011/65/EC of the European Parliament and of the Council (1). 4. Use of articles already in use in the Union before 25 August 2010 containing Tetrabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. Pentabromodiphenyl ether C12H5Br5O 32534-81-9 and others 251-084-2 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of pentabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentration of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed: electrical and electronic equipment within the scope of Directive 2011/65/EC. 4. Use of articles already in use in the Union before 25 August 2010 containing Pentabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. Hexabromodiphenyl ether C12H4Br6O 36483-60-0 and others 253-058-6 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of hexabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentration of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed: electrical and electronic equipment within the scope of Directive 2011/65/EC. 4. Use of articles already in use in the Union before 25 August 2010 containing Hexabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. Heptabromodiphenyl ether C12H3Br7O 68928-80-3 and others 273-031-2 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of heptabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentration of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed: electrical and electronic equipment within the scope of Directive 2011/65/EC. 4. Use of articles already in use in the Union before 25 August 2010 containing Heptabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. Bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE) 1163-19-5 214-604-9 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of decaBDE equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentrations of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of decaBDE shall be allowed for the following purposes, provided that Member States report to the Commission by December 2019 in accordance with the Convention: (a) in the manufacturing of an aircraft, for which type approval has been applied for before 2 March 2019 and has been received before December 2022, until 18 December 2023, or, in cases where the continuing need is justified, until 2 March 2027; (b) in the manufacturing of spare parts for either of the following: (i) an aircraft, for which type approval has been applied for before 2 March 2019 and has been received before December 2022, produced before 18 December 2023, or, in cases where the continuing need is justified, produced before 2 March 2027, until the end of service life of that aircraft; (ii) motor vehicles within the scope of Directive 2007/46/EC of the European Parliament and of the Council (2), produced before 15 July 2019, either until 2036 or the end of service life of those motor vehicles, whichever date comes earlier; (c) electric and electronic equipment within the scope of Directive 2011/65/EC. 4. The specific exemptions for spare parts for use in motor vehicles referred to in point 2(b)(ii) shall apply for the manufacturing and use of commercial decaBDE falling into one or more of the following categories: (a) powertrain and under-hood applications such as battery mass wires, battery interconnection wires, mobile air condition (MAC) pipes, powertrains, exhaust manifold bushings, under-hood insulation, wiring and harness under-hood (engine wiling, etc.), speed sensors, hoses, fan modules and knock sensors; (b) fuel system applications such as fuel hoses, fuel tanks and fuel tanks under body; (c) pyrotechnical devices and applications affected by pyrotechnical devices such as airbag ignition cables, seat covers/fabrics, only if airbag relevant and airbags (front and side). 5. Use of articles already in use before 15 July 2019 in the Union containing decaBDE shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. 6. Without prejudice to the application of other Union provisions on the classification, packaging and labelling of substances and mixtures, articles in which decaBDE is used shall be identifiable by labelling or other means throughout its life cycle. 7. The placing on the market and use of articles containing decaBDE imported for the purposes of the specific exemptions in point 2 shall be allowed until the expiry of those exemptions. Point 6 shall apply as if such articles were produced pursuant to the exemption in point 2. Such articles already in use by the date of expiry of the relevant exemption may continue to be used. 8. For the purposes of this entry \u2018aircraft\u2019 means the following: (a) a civil aircraft produced in accordance with a type certificate issued under Regulation (EC) No 216/2008 of the European Parliament and of the Council (3) or with a design approval issued under the national regulations of a contracting state of ICAO, or for which a certificate of airworthiness has been issued by an ICAO Contracting State under Annex 8 to the Convention on International Civil Aviation; (b) a military aircraft. Perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) 1763-23-1 2795-39-3 29457-72-5 29081-56-9 70225-14-8 56773-42-3 251099-16-8 4151-50-2 31506-32-8 1691-99-2 24448-09-7 307-35-7 and others 217-179-8 220-527-1 249-644-6 249-415-0 274-460-8 260-375-3 223-980-3 250-665-8 216-887-4 246-262-1 206-200-6 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOS equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances or in mixtures. 2. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOS in semi-finished products or articles, or parts thereof, if the concentration of PFOS is lower than 0,1 % by weight calculated with reference to the mass of structurally or micro-structurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is lower than 1 \u03bcg/m2 of the coated material. 3. Use of articles already in use in the Union before 25 August 2010 containing PFOS shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. 4. If the quantity released into the environment is minimised, manufacturing and placing on the market is allowed for the following specific uses provided that Member States report to the Commission every four years on progress made to eliminate PFOS: mist suppressants for non-decorative hard chromium (VI) plating in closed loop systems. Where such a derogation concerns production or use in an installation within the scope of Directive 2008/1/EC of the European Parliament and of the Council (4), the relevant best available techniques for the prevention and minimisation of emissions of PFOS described in the information published by the Commission pursuant to Article 17(2), second subparagraph, of Directive 2008/1/EC shall apply. As soon as new information on details of uses and safer alternative substances or technologies becomes available, the Commission shall review the derogation in the second subparagraph so that: (a) the uses of PFOS will be phased out as soon as the use of safer alternatives is technically and economically feasible; (b) a derogation can only be continued for essential uses for which safer alternatives do not exist and where the efforts undertaken to find safer alternatives have been reported on; (c) releases of PFOS into the environment have been minimised by applying best available techniques. 5. Once standards are adopted by the European Committee for Standardisation (CEN) they shall be used as the analytical test methods for demonstrating the conformity of substances, mixtures and articles to points 1 and 2. Any other analytical method for which the user can prove equivalent performance could be used as an alternative to the CEN standards. DDT (1,1,1-trichloro-2,2-bis(4-chlorophenyl)ethane) 50-29-3 200-024-3 \u2014 Chlordane 57-74-9 200-349-0 \u2014 Hexachlorocyclohexanes, including lindane 58-89-9 200-401-2 \u2014 319-84-6 206-270-8 319-85-7 206-271-3 608-73-1 210-168-9 Dieldrin 60-57-1 200-484-5 \u2014 Endrin 72-20-8 200-775-7 \u2014 Heptachlor 76-44-8 200-962-3 \u2014 Endosulfan 115-29-7 959-98-8 33213-65-9 204-079-4 1. Placing on the market and use of articles already in use before or on 10 July 2012 containing endosulfan shall be allowed. 2. Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1. Hexachlorobenzene 118-74-1 204-273-9 \u2014 Chlordecone 143-50-0 205-601-3 \u2014 Aldrin 309-00-2 206-215-8 \u2014 Pentachlorobenzene 608-93-5 210-172-0 \u2014 Polychlorinated Biphenyls (PCB) 1336-36-3 and others 215-648-1 and others Without prejudice to Directive 96/59/EC, articles already in use at the time of the entry into force of this Regulation are allowed to be used. Member States shall identify and remove from use equipment (e.g. transformers, capacitors or other receptacles containing liquid stocks) containing more than 0,005 % PCBs and volumes greater than 0,05 dm3, as soon as possible but no later than 31 December 2025. Mirex 2385-85-5 219-196-6 \u2014 Toxaphene 8001-35-2 232-283-3 \u2014 Hexabromobiphenyl 36355-01-8 252-994-2 \u2014 1 Hexabromocyclododecane \u2018Hexabromocyclododecane\u2019 means: hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane; beta-hexabromocyclododecane; and gamma-hexabromocyclododecane 25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8 247-148-4, 221-695-9 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of hexabromocyclododecane equal to or below 100 mg/kg (0,01 % by weight) where it is present in substances, mixtures, articles or as constituents of the flame-retarded articles, subject to review by the Commission by 22 March 2019. 2. Expanded polystyrene articles containing hexabromocyclododecane already in use in buildings before 21 February 2018 in accordance with Commission Regulation (EU) 2016/293 (5) and Commission Implementing Decision No 2016/C 12/06 (6), and extruded polystyrene articles containing hexabromocyclododecane already in use in buildings before 23 June 2016 may continue to be used. Article 4(2), third and fourth subparagraphs shall apply to such articles. 3. Without prejudice to the application of other Union provisions on the classification, packaging and labelling of substances and mixtures, expanded polystyrene placed on the market after 23 March 2016 in which hexabromocyclododecane was used shall be identifiable by labelling or other means throughout its life cycle. Hexachlorobutadiene 87-68-3 201-765-5 1. Placing on the market and use of articles already in use before or on 10 July 2012 containing hexachlorobutadiene shall be allowed. 2. Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1. Pentachlorophenol and its salts and esters 87-86-5 and others 201-778-6 and others Polychlorinated naphthalenes (7) 70776-03-3 and others 274-864-4 and others 1. Placing on the market and use of articles already in use before or on 10 July 2012 containing polychlorinated naphthalenes shall be allowed. 2. Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1. Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs) 85535-84-8 and others 287-476-5 1. By way of derogation, the manufacturing, placing on the market and use of substances or mixtures containing SCCPs in concentrations lower than 1 % by weight or articles containing SCCPs in concentrations lower than 0,15 % by weight shall be allowed. 2. Use shall be allowed in respect of: (a) conveyor belts in the mining industry and dam sealants containing SCCPs already in use before or on 4 December 2015; and (b) articles containing SCCPs other than those referred to in point (a) already in use before or on 10 July 2012. 3. The third and fourth subparagraphs of Article 4(2) shall apply to the articles referred to in point 2. Part B Substances listed only in the Protocol Substance CAS No EC No Specific exemption on intermediate use or other specification (1) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88). (2) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p.1). (3) Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1). (4) Directive 2008/1/EC of the European Parliament and of the Council of 15 January 2008 concerning integrated pollution prevention and control (OJ L 24, 29.1.2008, p. 8). (5) Commission Regulation (EU) 2016/293 of 1 March 2016 amending Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants as regards Annex I (OJ L 55, 2.3.2016, p. 4). (6) OJ C 10, 13.1.2016, p. 3. (7) Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms. ANNEX II LIST OF SUBSTANCES SUBJECT TO RESTRICTIONS Part A Substances listed in the Convention and in the Protocol Substance CAS No EC No Conditions of restriction Part B Substances listed only in the Protocol Substance CAS No EC No Conditions of restriction ANNEX III LIST OF SUBSTANCES SUBJECT TO RELEASE REDUCTION PROVISIONS PART A Substance (CAS No) Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) Polychlorinated biphenyls (PCB) PART B Hexachlorobenzene (HCB) (CAS No 118-74-1) Polycyclic aromatic hydrocarbons (PAHs) (1) Pentachlorobenzene (CAS No 608-93-5) Hexachlorobutadiene (CAS No 87-68-3) Polychlorinated naphthalenes (CAS No 70776-03-3 and others) (1) For the purpose of emission inventories, the following four compound indicators shall be used: benzo(a)pyrene, benzo(b) fluoranthene, benzo(k)fluoranthene and indeno(1,2,3-cd)pyrene. ANNEX IV List of substances subject to waste management provisions set out in Article 7 Substance CAS No EC No Concentration limit referred to in Article 7(4)(a) Endosulfan 115-29-7 959-98-8 33213-65-9 204-079-4 50 mg/kg Hexachlorobutadiene 87-68-3 201-765-5 100 mg/kg Polychlorinated naphthalenes (1) 10 mg/kg Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs) 85535-84-8 287-476-5 10 000 mg/kg Tetrabromodiphenyl ether C12H6Br4O 40088-47-9 and others 254-787-2 and others Sum of the concentrations of tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether, heptabromodiphenyl ether and decabromodiphenyl ether: 1 000 mg/kg. The Commission shall review that concentration limit and shall, where appropriate and in accordance with the Treaties, adopt a legislative proposal to lower that value to 500 mg/kg. The Commission shall carry out such review as soon as possible and, in any event, not later than 16 July 2021. Pentabromodiphenyl ether C12H5Br5O 32534-81-9 and others 251-084-2 and others Hexabromodiphenyl ether C12H4Br6O 36483-60-0 and others 253-058-6 and others Heptabromodiphenyl ether C12H3Br7O 68928-80-3 and others 273-031-2 and others Decabromodiphenyl ether C12Br10O 1163-19-5 and others 214-604-9 and others Perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) 1763-23-1 2795-39-3 29457-72-5 29081-56-9 70225-14-8 56773-42-3 251099-16-8 4151-50-2 31506-32-8 1691-99-2 24448-09-7 307-35-7 and others 217-179-8 220-527-1 249-644-6 249-415-0 274-460-8 260-375-3 223-980-3 250-665-8 216-887-4 246-262-1 206-200-6 and others 50 mg/kg Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) 15 \u03bcg/kg (2) DDT (1,1,1-trichloro-2,2-bis (4-chlorophenyl)ethane) 50-29-3 200-024-3 50 mg/kg Chlordane 57-74-9 200-349-0 50 mg/kg Hexachlorocyclohexanes, including lindane 58-89-9 319-84-6 319-85-7 608-73-1 210-168-9 200-401-2 206-270-8 206-271-3 50 mg/kg Dieldrin 60-57-1 200-484-5 50 mg/kg Endrin 72-20-8 200-775-7 50 mg/kg Heptachlor 76-44-8 200-962-3 50 mg/kg Hexachlorobenzene 118-74-1 204-273-9 50 mg/kg Chlordecone 143-50-0 205-601-3 50 mg/kg Aldrin 309-00-2 206-215-8 50 mg/kg Pentachlorobenzene 608-93-5 210-172-0 50 mg/kg Polychlorinated Biphenyls (PCB) 1336-36-3 and others 215-648-1 50 mg/kg (3) Mirex 2385-85-5 219-196-6 50 mg/kg Toxaphene 8001-35-2 232-283-3 50 mg/kg Hexabromobiphenyl 36355-01-8 252-994-2 50 mg/kg Hexabromocyclododecane (4) 25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8 247-148-4 221-695-9 1 000 mg/kg, subject to review by the Commission by 20 April 2019 (1) Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms. (2) The limit is calculated as PCDD and PCDF according to the following toxic equivalency factors (TEFs): PCDD TEF PCDF TEF PCDD TEF 2,3,7,8-TeCDD 1 2,3,7,8-TeCDF 0,1 1,2,3,6,7,8-HxCDF 0,1 1,2,3,7,8-PeCDD 1 1,2,3,7,8-PeCDF 0,03 1,2,3,7,8,9-HxCDF 0,1 1,2,3,4,7,8-HxCDD 0,1 2,3,4,7,8-PeCDF 0,3 2,3,4,6,7,8-HxCDF 0,1 1,2,3,6,7,8-HxCDD 0,1 1,2,3,4,7,8-HxCDF 0,1 1,2,3,4,6,7,8-HpCDF 0,01 1,2,3,7,8,9-HxCDD 0,1 1,2,3,4,7,8,9-HpCDF 0,01 1,2,3,4,6,7,8-HpCDD 0,01 OCDF 0,0003 OCDD 0,0003 (3) The calculation method laid down in European standards EN 12766-1 and EN 12766-2 shall apply. (4) \u2018Hexabromocyclododecane\u2019 means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane, beta-hexabromocyclododecane and gamma-hexabromocyclododecane. ANNEX V WASTE MANAGEMENT Part 1 Disposal and recovery under Article 7(2) The following disposal and recovery operations, as provided for in Annexes I and II of Directive 2008/98/EC, are permitted for the purposes of Article 7(2), when applied in such a way as to ensure that the persistent organic pollutant content is destroyed or irreversibly transformed D9 Physico-chemical treatment. D10 Incineration on land. R1 Use principally as a fuel or other means to generate energy, excluding waste containing PCBs. R4 Recycling/reclamation of metals and metal compounds, under the following conditions: The operations are restricted to residues from iron- and steel-making processes such as dusts or sludges from gas treatment or mill scale or zinc-containing filter dusts from steelworks, dusts from gas cleaning systems of copper smelters and similar wastes and lead-containing leaching residues of the non-ferrous metal production. Waste containing PCBs is excluded. The operations are restricted to processes for the recovery of iron and iron alloys (blast furnace, shaft furnace and hearth furnace) and non-ferrous metals (Waelz rotary kiln process, bath melting processes using vertical or horizontal furnaces), provided the facilities meet as minimum requirements the emission limit values for PCDDs and PCDFs laid down in accordance with Directive 2010/75/EU of the European Parliament and of the Council (1), whether or not the processes are subject to that Directive and without prejudice to the other provisions of the Directive. Pre-treatment operation prior to destruction or irreversible transformation pursuant to this Part of this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the waste during the pre-treatment is subsequently disposed of in accordance with this Part of this Annex. Where only part of a product or waste, such as waste equipment, contains or is contaminated with persistent organic pollutants, it shall be separated and then disposed of in accordance with the requirements of this Regulation. In addition, repackaging and temporary storage operations may be performed prior to such pre-treatment or prior to destruction or irreversible transformation pursuant to this part of this Annex. Part 2 Wastes and operations to which Article 7(4)(b) applies The following operations are permitted for the purposes of Article 7(4)(b) in respect of the wastes specified, defined by the six-digit code as classified in Commission Decision 2000/532/EC (2). Pre-treatment operations prior to permanent storage pursuant to this part of this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the waste during the pre-treatment is subsequently disposed of in accordance with Part 1 of this Annex. In addition, repackaging and temporary storage operations may be performed prior to such pre-treatment or prior to permanent storage pursuant to this part of this Annex. Wastes as classified in Decision 2000/532/EC Maximum concentration limits of substances listed in Annex IV (3) Operation 10 WASTES FROM THERMAL PROCESSES Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs): 10 000 mg/kg; Aldrin: 5 000 mg/kg; Chlordane: 5 000 mg/kg; Chlordecone: 5 000 mg/kg; DDT (1,1,1-trichloro-2,2-bis (4-chlorophenyl) ethane): 5 000 mg/kg; Dieldrin: 5 000 mg/kg; Endosulfan: 5 000 mg/kg; Endrin: 5 000 mg/kg; Heptachlor: 5 000 mg/kg; Hexabromobiphenyl: 5 000 mg/kg; Hexabromocyclododecane (5): 1 000 mg/kg; Hexachlorobenzene: 5 000 mg/kg; Hexachlorobutadiene: 1 000 mg/kg; Hexachlorocyclohexanes, including lindane: 5 000 mg/kg; Mirex: 5 000 mg/kg; Pentachlorobenzene: 5 000 mg/kg; Perfluorooctane sulfonic acid and its derivatives (PFOS) (C8F17SO2X) (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers): 50 mg/kg; Polychlorinated Biphenyls (PCB) (8): 50 mg/kg; Polychlorinated dibenzo-p-dioxins and dibenzofurans: 5 mg/kg; Polychlorinated naphthalenes (*): 1 000 mg/kg; Sum of the concentrations of tetrabromodiphenyl ether C12H6Br4O), pentabromodiphenyl ether (C12H5Br5O), hexabromodiphenyl ether (C12H4Br6O)and heptabromodiphenyl ether (C12H3Br7O): 10 000 mg/kg; Toxaphene: 5 000 mg/kg. Permanent storage shall be allowed only when all the following conditions are met: (1) The storage takes place in one of the following locations: \u2014 safe, deep, underground, hard rock formations, \u2014 salt mines, \u2014 a landfill site for hazardous waste, provided that the waste is solidified or partly stabilised where technically feasible as required for classification of the waste in subchapter 19 03 of Decision 2000/532/EC. (2) The provisions of Council Directive 1999/31/EC (6) and Council Decision 2003/33/EC (7) were respected. (3) It has been demonstrated that the selected operation is environmentally preferable. 10 01 Wastes from power stations and other combustion plants (except 19) 10 01 14 * (4) Bottom ash, slag and boiler dust from co-incineration containing hazardous substances 10 01 16 * Fly ash from co-incineration containing hazardous substances 10 02 Wastes from the iron and steel industry 10 02 07 * Solid wastes from gas treatment containing hazardous substances 10 03 Wastes from aluminium thermal metallurgy 10 03 04 * Primary production slags 10 03 08 * Salt slags from secondary production 10 03 09 * Black drosses from secondary production 10 03 19 * Flue-gas dust containing hazardous substances 10 03 21 * Other particulates and dust (including ball-mill dust) containing hazardous substances 10 03 29 * Wastes from treatment of salt slags and black drosses containing hazardous substances 10 04 Wastes from lead thermal metallurgy 10 04 01 * Slags from primary and secondary production 10 04 02 * Dross and skimmings from primary and secondary production 10 04 04 * Flue-gas dust 10 04 05 * Other particulates and dust 10 04 06 * Solid wastes from gas treatment 10 05 Wastes from zinc thermal metallurgy 10 05 03 * Flue-gas dust 10 05 05 * Solid waste from gas treatment 10 06 Wastes from copper thermal metallurgy 10 06 03 * Flue-gas dust 10 06 06 * Solid wastes from gas treatment 10 08 Wastes from other non-ferrous thermal metallurgy 10 08 08 * Salt slag from primary and secondary production 10 08 15 * Flue-gas dust containing hazardous substances 10 09 Wastes from casting of ferrous pieces 10 09 09 * Flue-gas dust containing hazardous substances 16 WASTES NOT OTHERWISE SPECIFIED IN THE LIST 16 11 Waste linings and refractories 16 11 01 * Carbon-based linings and refractories from metallurgical processes containing hazardous substances 16 11 03 * Other linings and refractories from metallurgical processes containing hazardous substances 17 CONSTRUCTION AND DEMOLITION WASTES (INCLUDING EXCAVATED SOIL FROM CONTAMINATED SITES) 17 01 Concrete, bricks, tiles and ceramics 17 01 06 * Mixtures of, or separate fractions of concrete, bricks, tiles and ceramics containing hazardous substances 17 05 Soil (including excavated soil from contaminated sites), stones and dredging spoil 17 05 03 * Soil and stones containing hazardous substances 17 09 Other construction and demolition wastes 17 09 02 * Construction and demolition wastes containing PCB, excluding PCB containing equipment 17 09 03 * Other construction and demolition wastes (including mixed wastes) containing hazardous substances 19 WASTES FROM WASTE MANAGEMENT FACILITIES, OFF-SITE WASTE WATER TREATMENT PLANTS AND THE PREPARATION OF WATER INTENDED FOR HUMAN CONSUMPTION AND WATER FROM INDUSTRIAL USE 19 01 Wastes from incineration or pyrolysis of waste 19 01 07 * Solid wastes from gas treatment 19 01 11 * Bottom ash and slag containing hazardous substances 19 01 13 * Fly ash containing hazardous substances 19 01 15 * Boiler dust containing hazardous substances 19 04 Vitrified waste and waste from vitrification 19 04 02 * Fly ash and other flue-gas treatment wastes 19 04 03 * Non-vitrified solid phase The maximum concentration limit of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD and PCDF) shall be calculated according to the following toxic equivalency factors (TEFs): PCDD TEF 2,3,7,8-TeCDD 1 1,2,3,7,8-PeCDD 1 1,2,3,4,7,8-HxCDD 0,1 1,2,3,6,7,8-HxCDD 0,1 1,2,3,7,8,9-HxCDD 0,1 1,2,3,4,6,7,8-HpCDD 0,01 OCDD 0,0003 PCDF TEF 2,3,7,8-TeCDF 0,1 1,2,3,7,8-PeCDF 0,03 2,3,4,7,8-PeCDF 0,3 1,2,3,4,7,8-HxCDF 0,1 1,2,3,6,7,8-HxCDF 0,1 1,2,3,7,8,9-HxCDF 0,1 2,3,4,6,7,8-HxCDF 0,1 1,2,3,4,6,7,8-HpCDF 0,01 1,2,3,4,7,8,9-HpCDF 0,01 OCDF 0,0003 (1) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17). (2) Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3). (3) These limits apply exclusively to a landfill site for hazardous waste and do not apply to permanent underground storage facilities for hazardous waste, including salt mines. (4) Any waste marked with an asterisk \u2018*\u2019 is considered as hazardous waste pursuant to Directive 2008/98/EC and is subject to the provisions of that Directive. (5) \u2018Hexabromocyclododecane\u2019 means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha- hexabromocyclododecane, beta- hexabromocyclododecane and gamma- hexabromocyclododecane. (6) Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999, p. 1). (7) Council Decision 2003/33/EC of 19 December 2002 establishing criteria and procedures for the acceptance of waste at landfills pursuant to Article 16 of and Annex II to Directive 1999/31/EC (OJ L 11, 16.1.2003, p. 27). (8) The calculation method laid down in European standards EN 12766-1 and EN 12766-2 shall apply. ANNEX VI Repealed Regulation with list of the successive amendments thereto Regulation (EC) No 850/2004 of the European Parliament and of the Council (OJ L 158, 30.4.2004, p. 7) Council Regulation (EC) No 1195/2006 (OJ L 217, 8.8.2006, p. 1) Council Regulation (EC) No 172/2007 (OJ L 55, 23.2.2007, p. 1) Commission Regulation (EC) No 323/2007 (OJ L 85, 27.3.2007, p. 3) Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ L 87, 31.3.2009, p. 109) Only point 3.7 of the Annex Commission Regulation (EC) No 304/2009 (OJ L 96, 15.4.2009, p. 33) Commission Regulation (EU) No 756/2010 (OJ L 223, 25.8.2010, p. 20) Commission Regulation (EU) No 757/2010 (OJ L 223, 25.8.2010, p. 29) Commission Regulation (EU) No 519/2012 (OJ L 159, 20.6.2012, p. 1) Commission Regulation (EU) No 1342/2014 (OJ L 363, 18.12.2014, p. 67) Commission Regulation (EU) 2015/2030 (OJ L 298, 14.11.2015, p. 1) Commission Regulation (EU) 2016/293 (OJ L 55, 2.3.2016, p. 4) Commission Regulation (EU) 2016/460 (OJ L 80, 31.3.2016, p. 17) ANNEX VII CORRELATION TABLE Regulation (EC) No 850/2004 This Regulation Article 1(1) Article 1 Article 2, introductory wording Article 2, introductory wording Article 2, points (a) to (d) Article 2, points (1) to (4) \u2014 Article 2, points (5) to (7) Article 2, point (e) Article 2, point (8) Article 2, point (f) Article 2, point (9) Article 2, point (g) Article 2, point (10) \u2014 Article 2, points (11) to (13) Article 3 Article 3(1) to (3) \u2014 Article 3(4) and (5) Article 1(2) Article 3(6) Article 4(1) to (3) Article 4(1) to (3) \u2014 Article 4(3), point (d) Article 1(2) Article 4(4) Article 5 Article 5 Article 6 Article 6 Article 7(1) to (4) Article 7(1) to (4) Article 7(6) Article 7(5) \u2014 Article 7(6) Article 7(7) \u2014 \u2014 Article 8 Article 8 Article 9 Article 9 Article 10 Article 10 Article 11 Article 11 Article 12 Article 12(1) Article 13(1), point (a) Article 12(3), point (a) Article 13(1), point (b) Article 12(3), point (b) Article 13(1), point (c) \u2014 Article 13(1), point (d) Article 12(3), point (c) Article 13(1), point (e) Article 12(2) Article 13(1), point (f) \u2014 Article 13(2) Article 12(4) \u2014 Article 12(5) Article 13(3) Article 12(6) \u2014 \u2014 Article 13(4) and (5) Article 13 Article 14 Article 14 Article 15(1) Article 7(5) Article 15(2) \u2014 Article 16 \u2014 Article 17 \u2014 Article 18 Article 15 Article 19 Articles 16 and 17 Article 20 Article 18 \u2014 \u2014 Article 21 Article 19 Article 22 Annexes I to V Annexes I to V \u2014 Annex VI \u2014 Annex VII", "summary": "Protecting health and the environment from persistent organic pollutants Protecting health and the environment from persistent organic pollutants SUMMARY OF: Regulation (EU) 2019/1021 on persistent organic pollutants WHAT IS THE AIM OF THE REGULATION? It aims to protect human health and the environment by eliminating, or restricting the production and use of persistent organic pollutants (POPs) as defined in the Stockholm Convention on Persistent Organic Pollutants or the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants. It seeks to minimise, or eliminate where possible, releases of such substances, and regulate waste containing or contaminated by them. The regulation particularly takes into account the precautionary principle. KEY POINTS POPs are potentially dangerous chemical substances which may cross international boundaries, are found often far from their emission sources, persist in the environment, bioaccumulate*, and consequently pose a threat to human health and the environment. Controls on manufacture, placing on the market*, and use The production and placing on the market of POPs listed in Annex I, whether on their own, in mixtures or in an article*, is banned. The production, placing on the market and use of POPs listed in Annex II is restricted to uses where locally safe, effective and affordable alternatives are not available to the country in question. EU countries and the European Commission must apply appropriate controls to existing substances (such as through listing) and prevent the production, placing on the market and use of any new substances which exhibit characteristics of POPs. EU countries may forward suggestions for listing to the Commission which, supported by the European Chemicals Agency (ECHA), decides whether to propose additional substances for listing. The ECHA also has a general advisory and informational role in the processes described in the regulation. Exemptions Exemptions from these controls are allowed for substances used for laboratory-scale research or as a reference standard, or which are present as an unintentional trace contaminant in mixtures or articles. Other exemptions apply to articles containing POPs manufactured prior to the regulation taking effect, subject to specific assurances and conditions, including requirements for notification to the Commission and the Stockholm Convention Secretariat. Release reduction, minimisation and elimination EU countries must: keep inventories of substances listed in Annex III released into air, water and land; communicate their action plans on measures to identify, characterise and minimise the release of substances, including the use of substitute or modified substances; give priority to alternative processes which avoid the formation and release of POPs when constructing or modifying facilities. Waste Those who produce or hold waste must avoid the waste being contaminated, as far as possible, with substances listed in Annex IV. In most cases, contaminated waste must be disposed of or recovered* quickly to ensure that the POP content is destroyed or transformed. EU countries must ensure that the production, collection and transportation of contaminated waste, as well as its storage and treatment, are traceable and carried out in conditions providing protection for the environment and human health. Planning, monitoring and reporting EU countries must give the public the opportunity to participate in this process and their implementation plans must be publicly available and shared with the Commission and the ECHA, including information on measures taken at national level to identify and assess sites contaminated by POPs, as appropriate. The Commission must also maintain an implementation plan which is to be reviewed and updated as appropriate. A monitoring mechanism must be established to gather comparable monitoring data on the presence of substances as listed in Part A of Annex III of the regulation in the environment. EU countries will also report on the implementation of the regulation. The Commission is empowered to adopt delegated acts to amend the list of substances in Annexes I, II and III of this regulation to adapt them to changes to the list of substances set out in the annexes to the Stockholm Convention or the 1979 Protocol. The regulation repeals and recasts Regulation (EC) No 850/2004. FROM WHEN DOES THE REGULATION APPLY? It has applied since 15 July 2019. BACKGROUND For more information, see: Persistent organic pollutants (POPs) (European Commission). KEY TERMS Bioaccumulate: become concentrated inside the bodies of living things. Placing on the market: supplying or making available, either in return for payment or free of charge, to a third party. Importing is also considered as \u2018placing on the market\u2019. Article: an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. Waste recovery: defined in the Waste Framework Directive as any operation the principal result of which is waste serving a useful purpose by replacing other materials which would otherwise have been used to fulfil a particular function, or waste being prepared to fulfil that function, in the plant or in the wider economy. MAIN DOCUMENT Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (recast) (OJ L 169, 25.6.2019, pp. 45-77) RELATED DOCUMENTS Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, pp. 3-30) Successive amendments to Directive 2008/98/EC have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, pp. 1-849). Text republished in corrigendum (OJ L 136, 29.5.2007, pp. 3-280) See consolidated version. Communication from the Commission on the precautionary principle (COM(2000) 1 final, 2.2.2000) Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L 81, 19.3.2004 pp. 37-71) last update 23.10.2019"}
{"article": "12.6.2019 EN Official Journal of the European Union L 155/1 DIRECTIVE (EU) 2019/904 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The high functionality and relatively low cost of plastic means that this material is increasingly ubiquitous in everyday life. While plastic plays a useful role in the economy and provides essential applications in many sectors, its growing use in short-lived applications, which are not designed for re-use or cost-effective recycling, means that related production and consumption patterns have become increasingly inefficient and linear. Therefore, in the context of the Circular Economy Action Plan laid down in the Communication of the Commission of 2 December 2015 entitled \u2018Closing the loop \u2013 An EU action plan for the Circular Economy\u2019, the Commission concluded in the European Strategy for Plastics laid down in its Communication of 16 January 2018 entitled \u2018A European Strategy for Plastics in a Circular Economy\u2019 that the steady increase in plastic waste generation and the leakage of plastic waste into the environment, in particular into the marine environment, must be tackled in order to achieve a circular life cycle for plastics. The European Strategy for Plastics is a step towards establishing a circular economy in which the design and production of plastics and plastic products fully respect re-use, repair and recycling needs and in which more sustainable materials are developed and promoted. The significant negative environmental, health and economic impact of certain plastic products calls for the setting up of a specific legal framework to effectively reduce those negative effects. (2) This Directive promotes circular approaches that give priority to sustainable and non-toxic re-usable products and re-use systems rather than to single-use products, aiming first and foremost to reduce the quantity of waste generated. Such waste prevention is at the pinnacle of the waste hierarchy enshrined in Directive 2008/98/EC of the European Parliament and of the Council (4). This Directive will contribute to the achievement of United Nations (UN) Sustainable Development Goal 12 to ensure sustainable consumption and production patterns, which is part of the 2030 Agenda for Sustainable Development adopted by the UN General Assembly on 25 September 2015. By retaining the value of products and materials for as long as possible and generating less waste, the economy of the Union can become more competitive and more resilient, while reducing pressure on precious resources and the environment. (3) Marine litter is transboundary in nature and is recognised as a growing global problem. Reducing marine litter is a key action for the achievement of UN Sustainable Development Goal 14 which calls to conserve and sustainably use the oceans, seas and marine resources for sustainable development. The Union must play its part in preventing and tackling marine litter and aim to be a standard setter for the world. In that context, the Union is working with partners in many international fora such as G20, G7 and the UN to promote concerted action and this Directive is part of the Union\u2019s efforts in that regard. In order for those efforts to be effective, it is also important that exports of plastic waste from the Union do not result in increased marine litter elsewhere. (4) In accordance with the United Nations Convention on the Law of the Sea of 10 December 1982 (UNCLOS) (5), the Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter of 29 December 1972 (\u2018London Convention\u2019) and its 1996 Protocol (\u2018London Protocol\u2019), Annex V to the International Convention for the Prevention of Pollution from Ships 1973 (MARPOL), as modified by the Protocol of 1978 relating thereto, and the Basel Convention on the control of transboundary movements of hazardous wastes and their disposal of 22 March 1989 (6) and with Union waste legislation, namely Directive 2008/98/EC and Directive 2000/59/EC of the European Parliament and of the Council (7), Member States are required to ensure environmentally sound waste management to prevent and reduce marine litter from both sea and land sources. In accordance with Union water legislation, namely Directives 2000/60/EC (8) and 2008/56/EC (9) of the European Parliament and of the Council, Member States are also required to tackle marine litter where it undermines the attainment of good environmental status of their marine waters, including as a contribution to UN Sustainable Development Goal 14. (5) In the Union, 80 to 85 % of marine litter, measured as beach litter counts, is plastic, with single-use plastic items representing 50 % and fishing-related items representing 27 % of the total. Single-use plastic products include a diverse range of commonly used fast-moving consumer products that are discarded after having been used once for the purpose for which they were provided, are rarely recycled, and are prone to becoming litter. A significant proportion of the fishing gear placed on the market is not collected for treatment. Single-use plastic products and fishing gear containing plastic are therefore a particularly serious problem in the context of marine litter, pose a severe risk to marine ecosystems, to biodiversity and to human health and damage activities such as tourism, fisheries and shipping. (6) Proper waste management remains essential for the prevention of all litter, including marine litter. Existing Union legislation, namely Directives 2008/98/EC, 2000/59/EC, 2000/60/EC and 2008/56/EC and Council Regulation (EC) No 1224/2009 (10), and policy instruments provide some regulatory responses to address marine litter. In particular, plastic waste is subject to overall Union waste management measures and targets, such as the recycling target for plastic packaging waste laid down in European Parliament and Council Directive 94/62/EC (11) and the objective in the European Strategy for Plastics to ensure that by 2030 all plastic packaging placed on the Union market is re-usable or easily recycled. However, the impact of those measures on marine litter is not sufficient and there are differences in the scope and the level of ambition amongst national measures to prevent and reduce marine litter. In addition, some of those measures, in particular marketing restrictions for single-use plastic products, could create barriers to trade and distort competition in the Union. (7) To focus efforts where they are most needed, this Directive should cover only those single-use plastic products that are found the most on beaches in the Union as well as fishing gear containing plastic and products made from oxo-degradable plastic. The single-use plastic products covered by measures under this Directive are estimated to represent around 86 % of the single-use plastics found, in counts, on beaches in the Union. Glass and metal beverage containers should not be covered by this Directive as they are not among the single-use plastic products that are found the most on beaches in the Union. (8) Microplastics do not fall directly within the scope of this Directive, yet they contribute to marine litter and the Union should therefore adopt a comprehensive approach to that problem. The Union should encourage all producers to strictly limit microplastics in their formulations. (9) Terrestrial pollution and contamination of soil by larger items of plastic and resulting fragments or microplastics can be significant and such plastic can leak into the marine environment. (10) This Directive is a lex specialis in relation to Directives 94/62/EC and 2008/98/EC. In the event of a conflict between those Directives and this Directive, this Directive should prevail within the scope of its application. That is the case for restrictions on placing on the market. In particular with regard to consumption reduction measures, product requirements, marking requirements and extended producer responsibility, this Directive supplements Directives 94/62/EC and 2008/98/EC and Directive 2014/40/EU of the European Parliament and of the Council (12). (11) Single-use plastic products can be manufactured from a wide range of plastics. Plastics are usually defined as polymeric materials to which additives may have been added. However, that definition would cover certain natural polymers. Unmodified natural polymers, within the meaning of the definition of \u2018not chemically modified substances\u2019 in point 40 of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (13), should not be covered by this Directive as they occur naturally in the environment. Therefore, for the purposes of this Directive, the definition of polymer in point 5 of Article 3 of Regulation (EC) No 1907/2006 should be adapted and a separate definition should be introduced. Plastics manufactured with modified natural polymers, or plastics manufactured from bio-based, fossil or synthetic starting substances are not naturally occurring and should therefore be addressed by this Directive. The adapted definition of plastics should therefore cover polymer-based rubber items and bio-based and biodegradable plastics regardless of whether they are derived from biomass or are intended to biodegrade over time. Paints, inks and adhesives should not be addressed by this Directive and therefore these polymeric materials should not be covered by the definition. (12) In order to clearly define the scope of this Directive, the term \u2018single-use plastic product\u2019 should be defined. The definition should exclude plastic products that are conceived, designed and placed on the market to accomplish within their life span multiple trips or rotations by being refilled or re-used for the same purpose for which they are conceived. Single-use plastic products are typically intended to be used just once or for a short period of time before being disposed of. Wet wipes for personal care and domestic use should also be within the scope of this Directive, whereas industrial wet wipes should be excluded. To further clarify whether a product is to be considered a single-use plastic product for the purposes of this Directive, the Commission should develop guidelines on single-use plastic products. In view of the criteria set out in this Directive, examples of food containers to be considered as single-use plastic products for the purposes of this Directive are fast-food containers or meal, sandwich, wrap and salad boxes with cold or hot food, or food containers of fresh or processed food that does not need further preparation, such as fruits, vegetables or desserts. Examples of food containers that are not to be considered as single-use plastic products for the purposes of this Directive are food containers with dried food or food that is sold cold requiring further preparation, containers containing food in more than single-serve portions or single-serve portion-sized food containers sold in more than one unit. Examples of beverage containers to be considered as single-use plastic products are beverage bottles or composite beverage packaging used for beer, wine, water, liquid refreshments, juices and nectars, instant beverages or milk, but not cups for beverages as these are a separate category of single-use plastic products for the purposes of this Directive. As they are not among the single-use plastic products that are found the most on beaches in the Union, glass and metal beverage containers should not be covered by this Directive. However, the Commission should, in the context of the review of this Directive, evaluate, inter alia, caps and lids made of plastic used for glass and metal beverage containers. (13) Single-use plastic products covered by this Directive should be addressed by one or several measures, depending on various factors, such as the availability of suitable and more sustainable alternatives, the feasibility of changing consumption patterns, and the extent to which they are already covered by existing Union legislation. (14) For certain single-use plastic products, suitable and more sustainable alternatives are not yet readily available and the consumption of most such single-use plastic products is expected to increase. To reverse that trend and to promote efforts towards more sustainable solutions, Member States should be required to take the necessary measures, for example by setting national consumption reduction targets, to achieve an ambitious and sustained reduction in the consumption of those products, without compromising food hygiene, food safety, good hygiene practices, good manufacturing practices, consumer information, or traceability requirements set out in Regulations (EC) No 178/2002 (14), (EC) No 852/2004 (15) and (EC) No 1935/2004 (16) of the European Parliament and of the Council and other relevant legislation related to food safety, hygiene and labelling. Member States should have the highest possible ambition for those measures, which should induce a substantial reversal of increasing consumption trends and lead to a measurable quantitative reduction. Those measures should take into account the impact of products throughout their life cycle, including when they are found in the marine environment, and should respect the waste hierarchy. Where Member States decide to implement that obligation through marketing restrictions, they should ensure that such restrictions are proportionate and non-discriminatory. Member States should encourage the use of products that are suitable for multiple use and that are, after having become waste, suitable for preparing for re-use and recycling. (15) For other single-use plastic products, suitable and more sustainable alternatives that are also affordable are readily available. In order to limit the adverse impact of such single-use plastic products on the environment, Member States should be required to prohibit their placing on the market. By doing so, the use of those readily available and more sustainable alternatives as well as of innovative solutions towards more sustainable business models, re-use alternatives and substitution of materials would be promoted. The restrictions on placing on the market introduced in this Directive should also cover products made from oxo-degradable plastic, as that type of plastic does not properly biodegrade and thus contributes to microplastic pollution in the environment, is not compostable, negatively affects the recycling of conventional plastic and fails to deliver a proven environmental benefit. Furthermore, in view of the high prevalence of expanded polystyrene litter in the marine environment and the availability of alternatives, single-use food and beverage containers and cups for beverages made of expanded polystyrene should also be restricted. (16) Tobacco product filters containing plastic are the second most found single-use plastic items on beaches in the Union. The huge environmental impact caused by post-consumption waste of tobacco products with filters containing plastic, discarded directly into the environment, needs to be reduced. Innovation and product development are expected to provide viable alternatives to filters containing plastic and need to be accelerated. Extended producer responsibility schemes for tobacco products with filters containing plastic should also encourage innovation leading to the development of sustainable alternatives to tobacco product filters containing plastic. Member States should promote a wide range of measures to reduce litter from post-consumption waste of tobacco products with filters containing plastic. (17) Caps and lids made of plastic which are used for beverage containers are among the single-use plastic items that are found the most on beaches in the Union. Therefore, beverage containers that are single-use plastic products should only be allowed to be placed on the market if they fulfil specific product design requirements that significantly reduce the dispersal into the environment of beverage container caps and lids made of plastic. For beverage containers that are both single-use plastic products and packaging, that requirement is in addition to the essential requirements on the composition and the re-usable and recoverable, including recyclable, nature of packaging set out in Annex II to Directive 94/62/EC. In order to facilitate conformity with the product design requirement and to ensure the smooth functioning of the internal market, it is necessary to develop a harmonised standard adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (17), and compliance with that standard should give rise to a presumption of conformity with those requirements. Therefore, the timely development of a harmonised standard is of the highest priority in ensuring effective implementation of this Directive. Sufficient time should be envisaged for the development of a harmonised standard and to allow the producers to adapt their production chains in relation to the implementation of the product design requirement. In order to ensure the circular use of plastics, the market uptake of recycled materials needs to be promoted. It is therefore appropriate to introduce requirements for a mandatory minimum content of recycled plastic in beverage bottles. (18) Plastic products should be manufactured taking into account their entire life span. The design of plastic products should always take into account the production and use phase and the reusability and recyclability of the product. In the context of the review to be undertaken pursuant to Article 9(5) of Directive 94/62/EC, the Commission should take into account the relative properties of different packaging materials, including composite materials, on the basis of life cycle assessments, addressing in particular waste prevention and design for circularity. (19) The presence of hazardous chemical substances in sanitary towels, tampons and tampon applicators should be avoided in the interest of women\u2019s health. In the framework of the restrictions process under Regulation (EC) No 1907/2006, it is appropriate for the Commission to assess further restrictions on such substances. (20) Certain single-use plastic products end up in the environment as a result of inappropriate disposal through the sewer system or other inappropriate release into the environment. Disposal through the sewer system can in addition cause substantial economic damage to sewer networks by clogging pumps and blocking pipes. For those products, there is frequently a significant lack of information about the material characteristics of the product or the appropriate means of waste disposal. Therefore, single-use plastic products that are frequently disposed of through the sewer system or otherwise inappropriately disposed of should be subject to marking requirements. The marking should inform consumers about appropriate waste management options for the product or which waste disposal means are to be avoided for the product in line with the waste hierarchy, and about the presence of plastics in the product as well as the resulting negative environmental impact of littering or of other inappropriate means of disposal of the product. The marking should, as appropriate, be either on the packaging of the product or directly on the product itself. The Commission should be empowered to establish harmonised specifications for the marking and when doing so should, where appropriate, test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and easily understandable. Marking requirements are already required for fishing gear pursuant to Regulation (EC) No 1224/2009. (21) With regard to single-use plastic products for which no suitable and more sustainable alternatives are readily available, Member States should, in line with the polluter-pays principle, also introduce extended producer responsibility schemes to cover the necessary costs of waste management and clean-up of litter as well as the costs of awareness raising measures to prevent and reduce such litter. Those costs should not exceed the costs that are necessary to provide those services in a cost-efficient way and should be established in a transparent way between the actors concerned. (22) Directive 2008/98/EC lays down general minimum requirements for extended producer responsibility schemes. Those requirements should apply to the extended producer responsibility schemes established by this Directive, irrespective of whether their mode of implementation is by legislative act or by means of agreements under this Directive. The relevance of some requirements depends on the characteristics of the product. Separate collection is not required to ensure proper treatment in line with the waste hierarchy for tobacco products with filters containing plastic, wet wipes and balloons. Therefore setting up separate collection for those products should not be mandatory. This Directive should establish extended producer responsibility requirements in addition to those laid down by Directive 2008/98/EC, for example, the requirement for producers of certain single-use plastic products to cover the costs of cleaning up litter. It should also be possible to cover the costs of the setting up of specific infrastructure for collection of post-consumption waste of tobacco products, such as appropriate waste receptacles in common litter hotspots. The calculation methodology for the costs of cleaning up litter should take into account considerations of proportionality. To minimise administrative costs, Member States should be able to determine financial contributions towards the costs of cleaning up litter by setting appropriate multiannual fixed amounts. (23) The large percentage of plastic stemming from discarded fishing gear, including abandoned and lost fishing gear, in marine litter indicates that the existing legal requirements laid down in Regulation (EC) No 1224/2009, Directive 2000/59/EC and Directive 2008/98/EC do not provide sufficient incentives to return such fishing gear to shore for collection and treatment. The indirect fee system set up under Directive (EU) 2019/883 of the European Parliament and of the Council (18) provides a system for removing the incentive for ships to discharge their waste at sea, and ensures a right of delivery. That system should, however, be supplemented by further financial incentives for fishermen to bring their waste fishing gear on shore to avoid any potential increase in the indirect waste fee to be paid. As plastic components of fishing gear have high recycling potential, Member States should, in line with the polluter-pays principle, introduce extended producer responsibility for fishing gear and components of fishing gear containing plastic to ensure separate collection of waste fishing gear and to finance environmentally sound waste management of waste fishing gear, in particular recycling. (24) In the framework of an extended producer responsibility for fishing gear containing plastic, Member States should monitor and assess, in line with the reporting obligations laid down in this Directive, fishing gear containing plastic. (25) While all marine litter containing plastic poses a risk to the environment and to human health and should be tackled, proportionality considerations should also be taken into account. Therefore, the fishermen themselves and artisanal makers of fishing gear containing plastic should not be considered as producers and should not be held responsible for fulfilling the obligations of the producer related to the extended producer responsibility. (26) Economic and other incentives to support sustainable consumer choices and promote responsible consumer behaviour can be an effective tool for achieving the objectives of this Directive. (27) Beverage bottles that are single-use plastic products are one of the marine litter items that are found the most on beaches in the Union. This is due to ineffective separate collection systems and low participation in those systems by consumers. It is necessary to promote more effective separate collection systems. Therefore, a minimum separate collection target should be established for beverage bottles that are single-use plastic products. While the obligation to separately collect waste requires that waste be kept separate by type and nature, it should be possible to collect certain types of waste together provided that this does not impede high-quality recycling in line with the waste hierarchy in accordance with Article 10(2) and point (a) of Article 10(3) of Directive 2008/98/EC. The setting of the separate collection target should be based on the amount of single-use plastic beverage bottles placed on the market in a Member State or alternatively on the amount of waste single-use plastic beverage bottles generated in a Member State. The calculation of the amount of waste generated in a Member State should take due account of all waste single-use plastic beverage bottles generated, including those which become litter instead of being disposed of through waste collection systems. Member States should be able to achieve that minimum target by setting separate collection targets for beverage bottles that are single-use plastic products in the framework of the extended producer responsibility schemes, by establishing deposit-refund schemes or by any other measure that they find appropriate. That will have a direct, positive impact on the collection rate, the quality of the collected material and the quality of the recyclates, offering opportunities for the recycling business and the market for the recyclates. It will support reaching the recycling targets for packaging waste set in Directive 94/62/EC. (28) In order to prevent littering and other inappropriate means of waste disposal resulting in marine litter containing plastic, it is necessary for consumers of single-use plastic products and users of fishing gear containing plastic to be properly informed about the availability of re-usable alternatives and re-use systems, the most appropriate waste management options available and/or which waste disposal options are to be avoided, about best practices with regard to sound waste management and the environmental impact of bad disposal practices, as well as about the plastic content in certain single-use plastic products and fishing gear and the impact of inappropriate waste disposal on the sewer network. Member States should therefore be required to take awareness raising measures ensuring that such information is provided to those consumers and users. The information should not contain any promotional content encouraging the use of single-use plastic products. Member States should be able to choose the measures which are the most appropriate based on the nature of the product or its use. Producers of single-use plastic products and fishing gear containing plastic should cover the costs of the awareness raising measures as part of their extended producer responsibility obligations. (29) The aim of this Directive is to protect the environment and human health. As the Court of Justice has held on numerous occasions, it would be incompatible with the binding effect which the third paragraph of Article 288 of the Treaty on the Functioning of the European Union ascribes to a Directive, to exclude, in principle, the possibility of an obligation imposed by a Directive from being relied on by persons concerned. That consideration applies particularly in respect of a Directive which has as its objective to prevent and reduce the impact of certain plastic products on the aquatic environment. (30) It is important to monitor the levels of marine litter in the Union in order to assess the implementation of this Directive. In accordance with Directive 2008/56/EC, Member States are required to regularly monitor the properties and quantities of marine litter, including plastic marine litter. That monitoring data is also to be communicated to the Commission. (31) Member States should lay down rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and should take all measures necessary to ensure that they are implemented. The penalties provided for should be effective, proportionate and dissuasive. (32) Pursuant to paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (19), the Commission should carry out an evaluation of this Directive. That evaluation should be based on experience gathered and data collected during the implementation of this Directive and data collected under Directives 2008/56/EC and 2008/98/EC. The evaluation should provide the basis for an assessment of possible further measures, including the setting of Union-wide reduction targets for 2030 and beyond, and an assessment whether, in view of monitoring of marine litter in the Union, the Annex listing single-use plastic products needs to be reviewed and whether the scope of this Directive can be broadened to other single-use products. (33) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission in respect of the methodology for the calculation and verification of the annual consumption of single-use plastic products for which consumption reduction objectives have been set, the rules for the calculation and verification of the attainment of the targets on minimum recycled content for single-use plastic beverage bottles, the specifications for the marking to be affixed on certain single-use plastic products, the methodology for the calculation and verification of the collection targets of single-use plastic products for which separate collection targets have been set and the format for the reporting of data and information on the implementation of this Directive. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (20). (34) It is appropriate to allow Member States to choose to implement certain provisions of this Directive by means of agreements between the competent authorities and the economic sectors concerned, provided that certain requirements are met. (35) The fight against litter is a shared effort between competent authorities, producers and consumers. Public authorities, including the Union institutions, should lead by example. (36) Since the objectives of this Directive, namely to prevent and to reduce the impact of certain single-use plastic products, products made from oxo-degradable plastic and fishing gear containing plastic on the environment and on human health, and to promote the transition to a circular economy, including the fostering of innovative and sustainable business models, products and materials, thus also contributing to the efficient functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS DIRECTIVE: Article 1 Objectives The objectives of this Directive are to prevent and reduce the impact of certain plastic products on the environment, in particular the aquatic environment, and on human health, as well as to promote the transition to a circular economy with innovative and sustainable business models, products and materials, thus also contributing to the efficient functioning of the internal market. Article 2 Scope 1. This Directive applies to the single-use plastic products listed in the Annex, to products made from oxo-degradable plastic and to fishing gear containing plastic. 2. Where this Directive conflicts with Directive 94/62/EC or 2008/98/EC, this Directive shall prevail. Article 3 Definitions For the purposes of this Directive, the following definitions apply: (1) \u2018plastic\u2019 means a material consisting of a polymer as defined in point 5 of Article 3 of Regulation (EC) No 1907/2006, to which additives or other substances may have been added, and which can function as a main structural component of final products, with the exception of natural polymers that have not been chemically modified; (2) \u2018single-use plastic product\u2019 means a product that is made wholly or partly from plastic and that is not conceived, designed or placed on the market to accomplish, within its life span, multiple trips or rotations by being returned to a producer for refill or re-used for the same purpose for which it was conceived; (3) \u2018oxo-degradable plastic\u2019 means plastic materials that include additives which, through oxidation, lead to the fragmentation of the plastic material into micro-fragments or to chemical decomposition; (4) \u2018fishing gear\u2019 means any item or piece of equipment that is used in fishing or aquaculture to target, capture or rear marine biological resources or that is floating on the sea surface, and is deployed with the objective of attracting and capturing or of rearing such marine biological resources; (5) \u2018waste fishing gear\u2019 means any fishing gear covered by the definition of waste in point 1 of Article 3 of Directive 2008/98/EC, including all separate components, substances or materials that were part of or attached to such fishing gear when it was discarded, including when it was abandoned or lost; (6) \u2018placing on the market\u2019 means the first making available of a product on the market of a Member State; (7) \u2018making available on the market\u2019 means any supply of a product for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge; (8) \u2018harmonised standard\u2019 means a harmonised standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012; (9) \u2018waste\u2019 means waste as defined in point 1 of Article 3 of Directive 2008/98/EC; (10) \u2018extended producer responsibility scheme\u2019 means extended producer responsibility scheme as defined in point 21 of Article 3 of Directive 2008/98/EC; (11) \u2018producer\u2019 means: (a) any natural or legal person established in a Member State that professionally manufactures, fills, sells or imports, irrespective of the selling technique used, including by means of distance contracts as defined in point (7) of Article 2 of Directive 2011/83/EU of the European Parliament and of the Council (21), and places on the market of that Member State single-use plastic products, filled single-use plastic products or fishing gear containing plastic, other than persons carrying out fishing activities as defined in point (28) of Article 4 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (22); or (b) any natural or legal person established in one Member State or in a third country that professionally sells in another Member State directly to private households or to users other than private households, by means of distance contracts as defined in point (7) of Article 2 of Directive 2011/83/EU, single-use plastic products, filled single-use plastic products or fishing gear containing plastic, other than persons carrying out fishing activities as defined in point (28) of Article 4 of Regulation (EU) No 1380/2013; (12) \u2018collection\u2019 means collection as defined in point 10 of Article 3 of Directive 2008/98/EC; (13) \u2018separate collection\u2019 means separate collection as defined in point 11 of Article 3 of Directive 2008/98/EC; (14) \u2018treatment\u2019 means treatment as defined in point 14 of Article 3 of Directive 2008/98/EC; (15) \u2018packaging\u2019 means packaging as defined in point 1 of Article 3 of Directive 94/62/EC; (16) \u2018biodegradable plastic\u2019 means a plastic capable of undergoing physical, biological decomposition, such that it ultimately decomposes into carbon dioxide (CO2), biomass and water, and is, in accordance with European standards for packaging, recoverable through composting and anaerobic digestion; (17) \u2018port reception facilities\u2019 means port reception facilities as defined in point (e) of Article 2 of Directive 2000/59/EC; (18) \u2018tobacco products\u2019 means tobacco products as defined in point (4) of Article 2 of Directive 2014/40/EU. Article 4 Consumption reduction 1. Member States shall take the necessary measures to achieve an ambitious and sustained reduction in the consumption of the single-use plastic products listed in Part A of the Annex, in line with the overall objectives of the Union\u2019s waste policy, in particular waste prevention, leading to a substantial reversal of increasing consumption trends. Those measures shall achieve a measurable quantitative reduction in the consumption of the single-use plastic products listed in Part A of the Annex on the territory of the Member State by 2026 compared to 2022. By 3 July 2021, Member States shall prepare a description of the measures which they have adopted pursuant to the first subparagraph, notify the description to the Commission and make it publicly available. Member States shall integrate the measures set out in the description into the plans or programmes referred to in Article 11 upon the first subsequent update of those plans or programmes in accordance with the relevant legislative acts of the Union governing those plans or programmes, or into any other programmes drawn up specifically for that purpose. The measures may include national consumption reduction targets, measures ensuring that re-usable alternatives to the single-use plastic products listed in Part A of the Annex are made available at the point of sale to the final consumer, economic instruments such as instruments ensuring that those single-use plastic products are not provided free of charge at the point of sale to the final consumer and agreements as referred to in Article 17(3). Member States may impose marketing restrictions in derogation from Article 18 of Directive 94/62/EC for the purposes of preventing such products from becoming litter in order to ensure that they are substituted with alternatives that are re-usable or do not contain plastic. The measures may vary depending on the environmental impact of those single-use plastic products over their life cycle, including when they become litter. Measures adopted pursuant to this paragraph shall be proportionate and non-discriminatory. Member States shall notify the Commission of those measures in accordance with Directive (EU) 2015/1535 of the European Parliament and of the Council (23) where so required by that Directive. In order to comply with the first subparagraph of this paragraph, each Member State shall monitor the single-use plastic products listed in Part A of the Annex placed on the market and the reduction measures taken and shall report on progress made to the Commission in accordance with paragraph 2 of this Article and Article 13(1) with a view to the establishment of binding quantitative Union targets for consumption reduction. 2. By 3 January 2021, the Commission shall adopt an implementing act laying down the methodology for the calculation and verification of the ambitious and sustained reduction in the consumption of the single-use plastic products listed in Part A of the Annex. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 16(2). Article 5 Restrictions on placing on the market Member States shall prohibit the placing on the market of the single-use plastic products listed in Part B of the Annex and of products made from oxo-degradable plastic. Article 6 Product requirements 1. Member States shall ensure that single-use plastic products listed in Part C of the Annex that have caps and lids made of plastic may be placed on the market only if the caps and lids remain attached to the containers during the products\u2019 intended use stage. 2. For the purposes of this Article, metal caps or lids with plastic seals shall not be considered to be made of plastic. 3. By 3 October 2019, the Commission shall request the European standardisation organisations to develop harmonised standards relating to the requirement referred to in paragraph 1. Those standards shall in particular address the need to ensure the necessary strength, reliability and safety of beverage container closures, including those for carbonated drinks. 4. From the date of publication of the references to harmonised standards referred to in paragraph 3 in the Official Journal of the European Union, single-use plastic products referred to in paragraph 1 which are in conformity with those standards or parts thereof shall be presumed to be in conformity with the requirement laid down in paragraph 1. 5. With regard to beverage bottles listed in Part F of the Annex, each Member State shall ensure that: (a) from 2025, beverage bottles listed in Part F of the Annex which are manufactured from polyethylene terephthalate as the major component (\u2018PET bottles\u2019) contain at least 25 % recycled plastic, calculated as an average for all PET bottles placed on the market on the territory of that Member State; and (b) from 2030, beverage bottles listed in Part F of the Annex contain at least 30 % recycled plastic, calculated as an average for all such beverage bottles placed on the market on the territory of that Member State. By 1 January 2022, the Commission shall adopt implementing acts laying down the rules for the calculation and verification of the targets established in the first subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2). Article 7 Marking requirements 1. Member States shall ensure that each single-use plastic product listed in Part D of the Annex placed on the market bears a conspicuous, clearly legible and indelible marking on its packaging or on the product itself informing consumers of the following: (a) appropriate waste management options for the product or waste disposal means to be avoided for that product, in line with the waste hierarchy; and (b) the presence of plastics in the product and the resulting negative impact of littering or other inappropriate means of waste disposal of the product on the environment. The harmonised marking specifications shall be established by the Commission in accordance with paragraph 2. 2. By 3 July 2020, the Commission shall adopt an implementing act establishing harmonised specifications for the marking referred to in paragraph 1 that: (a) provide that the marking of single-use plastic products listed in points (1), (2) and (3) of Part D of the Annex shall be placed on the sales and grouped packaging of those products. Where multiple sales units are grouped at the point of purchase, each sales unit shall bear a marking on its packaging. The marking shall not be required for packaging with a surface area of less than 10 cm2; (b) provide that the marking of single-use plastic products listed in point (4) of Part D of the Annex shall be placed on the product itself; and (c) consider existing sectoral voluntary approaches and pay particular attention to the need to avoid information that misleads consumers. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 16(2). 3. The provisions of this Article concerning tobacco products are in addition to those laid down in Directive 2014/40/EU. Article 8 Extended producer responsibility 1. Member States shall ensure that extended producer responsibility schemes are established for all single-use plastic products listed in Part E of the Annex which are placed on the market of the Member State, in accordance with Articles 8 and 8a of Directive 2008/98/EC. 2. Member States shall ensure that the producers of the single-use plastic products listed in Section I of Part E of the Annex to this Directive cover the costs pursuant to the extended producer responsibility provisions in Directives 2008/98/EC and 94/62/EC and, insofar as not already included, cover the following costs: (a) the costs of the awareness raising measures referred to in Article 10 of this Directive regarding those products; (b) the costs of waste collection for those products that are discarded in public collection systems, including the infrastructure and its operation, and the subsequent transport and treatment of that waste; and (c) the costs of cleaning up litter resulting from those products and the subsequent transport and treatment of that litter. 3. Member States shall ensure that the producers of the single-use plastic products listed in Sections II and III of Part E of the Annex cover at least the following costs: (a) the costs of the awareness raising measures referred to in Article 10 regarding those products; (b) the costs of cleaning up litter resulting from those products and the subsequent transport and treatment of that litter; and (c) the costs of data gathering and reporting in accordance with point (c) of Article 8a(1) of Directive 2008/98/EC. With regard to the single-use plastic products listed in Section III of Part E of the Annex to this Directive, Member States shall ensure that the producers cover, in addition, the costs of waste collection for those products that are discarded in public collection systems, including the infrastructure and its operation, and the subsequent transport and treatment of that waste. The costs may include the setting up of specific infrastructure for the waste collection for those products, such as appropriate waste receptacles in common litter hotspots. 4. The costs to be covered referred to in paragraphs 2 and 3 shall not exceed the costs that are necessary to provide the services referred to therein in a cost-efficient way and shall be established in a transparent way between the actors concerned. The costs of cleaning up litter shall be limited to activities undertaken by public authorities or on their behalf. The calculation methodology shall be developed in a way that allows for the costs of cleaning up litter to be established in a proportionate way. To minimise administrative costs, Member States may determine financial contributions towards the costs of cleaning up litter by setting appropriate multiannual fixed amounts. The Commission shall publish guidelines for criteria, in consultation with Member States, on the costs of cleaning up litter referred to in paragraphs 2 and 3. 5. Member States shall define in a clear way the roles and responsibilities of all relevant actors involved. With regard to packaging, those roles and responsibilities shall be defined in line with Directive 94/62/EC. 6. Each Member State shall allow the producers established in another Member State and placing products on its market to appoint a legal or natural person established on its territory as an authorised representative for the purposes of fulfilling the obligations of a producer related to extended producer responsibility schemes on its territory. 7. Each Member State shall ensure that a producer established on its territory, which sells single-use plastic products listed in Part E of the Annex and fishing gear containing plastic in another Member State in which it is not established, appoints an authorised representative in that other Member State. The authorised representative shall be the person responsible for fulfilling the obligations of that producer pursuant to this Directive on the territory of that other Member State. 8. Member States shall ensure that extended producer responsibility schemes are established for fishing gear containing plastic placed on the market of the Member State, in accordance with Articles 8 and 8a of Directive 2008/98/EC. Member States that have marine waters as defined in point 1 of Article 3 of Directive 2008/56/EC shall set a national minimum annual collection rate of waste fishing gear containing plastic for recycling. Member States shall monitor fishing gear containing plastic placed on the market of the Member State as well as waste fishing gear containing plastic collected and shall report to the Commission in accordance with Article 13(1) of this Directive with a view to the establishment of binding quantitative Union collection targets. 9. With regard to the extended producer responsibility schemes established pursuant to paragraph 8 of this Article, Member States shall ensure that the producers of fishing gear containing plastic cover the costs of the separate collection of waste fishing gear containing plastic that has been delivered to adequate port reception facilities in accordance with Directive (EU) 2019/883 or to other equivalent collection systems that fall outside the scope of that Directive and the costs of its subsequent transport and treatment. The producers shall also cover the costs of the awareness raising measures referred to in Article 10 regarding fishing gear containing plastic. The requirements laid down in this paragraph supplement the requirements applicable to waste from fishing vessels in Union law on port reception facilities. Without prejudice to technical measures laid down in Council Regulation (EC) No 850/98 (24), the Commission shall request the European standardisation organisations to develop harmonised standards relating to the circular design of fishing gear to encourage preparing for re-use and facilitate recyclability at end of life. Article 9 Separate collection 1. Member States shall take the necessary measures to ensure the separate collection for recycling: (a) by 2025, of an amount of waste single-use plastic products listed in Part F of the Annex equal to 77 % of such single-use plastic products placed on the market in a given year by weight; (b) by 2029, of an amount of waste single-use plastic products listed in Part F of the Annex equal to 90 % of such single-use plastic products placed on the market in a given year by weight. Single-use plastic products listed in Part F of the Annex placed on the market in a Member State may be deemed to be equal to the amount of waste generated from such products, including as litter, in the same year in that Member State. In order to achieve that objective, Member States may inter alia: (a) establish deposit-refund schemes; (b) establish separate collection targets for relevant extended producer responsibility schemes. The first subparagraph shall apply without prejudice to point (a) of Article 10(3) of Directive 2008/98/EC. 2. The Commission shall facilitate the exchange of information and sharing of best practices among Member States on the appropriate measures to meet the targets laid down in paragraph 1, inter alia, on deposit-refund schemes. The Commission shall make the results of such exchange of information and sharing of best practices publicly available. 3. By 3 July 2020, the Commission shall adopt an implementing act laying down the methodology for the calculation and verification of the separate collection targets laid down in paragraph 1 of this Article. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 16(2). Article 10 Awareness raising measures Member States shall take measures to inform consumers and to incentivise responsible consumer behaviour, in order to reduce litter from products covered by this Directive, and shall take measures to inform consumers of the single-use plastic products listed in Part G of the Annex and users of fishing gear containing plastic about the following: (a) the availability of re-usable alternatives, re-use systems and waste management options for those single-use plastic products and for fishing gear containing plastic as well as best practices in sound waste management carried out in accordance with Article 13 of Directive 2008/98/EC; (b) the impact of littering and other inappropriate waste disposal of those single-use plastic products and of fishing gear containing plastic on the environment, in particular on the marine environment; and (c) the impact of inappropriate means of waste disposal of those single-use plastic products on the sewer network. Article 11 Coordination of measures Without prejudice to the first subparagraph of Article 4(1) of this Directive, each Member State shall ensure that the measures taken to transpose and implement this Directive form an integral part of and are consistent with its programmes of measures established in accordance with Article 13 of Directive 2008/56/EC for those Member States that have marine waters, the programmes of measures established in accordance with Article 11 of Directive 2000/60/EC, waste management plans and waste prevention programmes established in accordance with Articles 28 and 29 of Directive 2008/98/EC and the waste reception and handling plans established under Directive (EU) 2019/883. The measures that Member States take to transpose and implement Articles 4 to 9 of this Directive shall comply with Union food law to ensure that food hygiene and food safety are not compromised. Member States shall encourage the use of sustainable alternatives to single-use plastic where possible for materials intended to come into contact with food. Article 12 Specifications and guidelines on single-use plastic products In order to determine whether a food container is to be considered as a single-use plastic product for the purposes of this Directive, in addition to the criteria listed in the Annex as regards food containers, its tendency to become litter, due to its volume or size, in particular single-serve portions, shall play a decisive role. By 3 July 2020, the Commission shall publish guidelines, in consultation with Member States, including examples of what is to be considered a single-use plastic product for the purposes of this Directive, as appropriate. Article 13 Information systems and reporting 1. Member States shall, for each calendar year, report to the Commission the following: (a) data on single-use plastic products listed in Part A of the Annex that have been placed on the market of the Member State each year, to demonstrate the consumption reduction in accordance with Article 4(1); (b) information on the measures taken by the Member State for the purposes of Article 4(1); (c) data on single-use plastic products listed in Part F of the Annex that have been separately collected in the Member State each year, to demonstrate the attainment of the separate collection targets in accordance with Article 9(1); (d) data on fishing gear containing plastic placed on the market and on waste fishing gear collected in the Member State each year; (e) information on recycled content in beverage bottles listed in Part F of the Annex to demonstrate the attainment of the targets laid down in Article 6(5); and (f) data on the post-consumption waste of single-use plastic products listed in Section III of Part E of the Annex that has been collected in accordance with Article 8(3). Member States shall report the data and information electronically within 18 months of the end of the reporting year for which they were collected. The data and information shall be reported in the format established by the Commission in accordance with paragraph 4 of this Article. The first reporting period shall be the calendar year 2022, with the exception of points (e) and (f) of the first subparagraph for which the first reporting period shall be the calendar year 2023. 2. The data and information reported by Member States in accordance with this Article shall be accompanied by a quality check report. The data and information shall be reported in the format established by the Commission in accordance with paragraph 4. 3. The Commission shall review the data and information reported in accordance with this Article and publish a report on the results of its review. The report shall assess the organisation of the collection of the data and information, the sources of data and information and the methodology used in Member States as well as the completeness, reliability, timeliness and consistency of that data and information. The assessment may include specific recommendations for improvement. The report shall be drawn up after the first reporting of the data and information by the Member States and thereafter at the intervals envisaged in Article 12(3c) of Directive 94/62/EC. 4. By 3 January 2021, the Commission shall adopt implementing acts laying down the format for reporting data and information in accordance with points (a) and (b) of paragraph 1 and with paragraph 2 of this Article. By 3 July 2020, the Commission shall adopt implementing acts laying down the format for reporting data in accordance with points (c) and (d) of paragraph 1 and with paragraph 2 of this Article. By 1 January 2022, the Commission shall adopt implementing acts laying down the format for reporting data and information in accordance with points (e) and (f) of paragraph 1 and with paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2). The format developed according to Article 12 of Directive 94/62/EC shall be taken into consideration. Article 14 Penalties Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 3 July 2021, notify the Commission of those rules and those measures and shall notify it of any subsequent amendment affecting them. Article 15 Evaluation and review 1. The Commission shall carry out an evaluation of this Directive by 3 July 2027. The evaluation shall be based on the information available in accordance with Article 13. Member States shall provide the Commission with any additional information necessary for the purposes of the evaluation and the preparation of the report referred to in paragraph 2 of this Article. 2. The Commission shall submit a report on the main findings of the evaluation carried out in accordance with paragraph 1 to the European Parliament, the Council and the European Economic and Social Committee. The report shall be accompanied by a legislative proposal, if appropriate. That proposal shall, if appropriate, set binding quantitative consumption reduction targets and set binding collection rates for waste fishing gear. 3. The report shall include: (a) an assessment of the need to review the Annex listing single-use plastic products, including as regards caps and lids made of plastic which are used for glass and metal beverage containers; (b) a study of the feasibility of establishing binding collection rates for waste fishing gear and binding quantitative Union targets for the consumption reduction of, in particular, single-use plastic products listed in Part A of the Annex, taking into account consumption levels and already achieved reductions in Member States; (c) an assessment of the change in materials used in the single-use plastic products covered by this Directive as well as of new consumption patterns and business models based on re-usable alternatives; this shall, wherever possible, include an overall life cycle analysis to assess the environmental impact of such products and their alternatives; and (d) an assessment of the scientific and technical progress concerning criteria or a standard for biodegradability in the marine environment applicable to single-use plastic products within the scope of this Directive and their single-use substitutes which ensure full decomposition into carbon dioxide (CO2), biomass and water within a timescale short enough for the plastics not to be harmful to marine life and not to lead to an accumulation of plastics in the environment. 4. As part of the evaluation carried out pursuant to paragraph 1, the Commission shall review the measures taken under this Directive as regards single-use plastic products listed in Section III of Part E of the Annex and shall submit a report on the main findings. The report shall also consider the options for binding measures for the reduction of the post-consumption waste of single-use plastic products listed in Section III of Part E of the Annex, including the possibility of setting binding collection rates for that post-consumption waste. The report shall, if appropriate, be accompanied by a legislative proposal. Article 16 Committee procedure 1. The Commission shall be assisted by the Committee established by Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 17 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 3 July 2021. They shall immediately inform the Commission thereof. However, the Member States shall apply the measures necessary to comply with: \u2014 Article 5 from 3 July 2021, \u2014 Article 6(1) from 3 July 2024, \u2014 Article 7(1) from 3 July 2021, \u2014 Article 8 by 31 December 2024 but, in relation to extended producer responsibility schemes established before 4 July 2018 and in relation to single-use plastic products listed in Section III of Part E of the Annex, by 5 January 2023. When Member States adopt the measures referred to in this paragraph, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive. 3. Provided that the waste management targets and objectives set out in Articles 4 and 8 are achieved, Member States may transpose the provisions set out in Articles 4(1) and 8(1) and (8), except as regards single-use plastic products listed in Section III of Part E of the Annex, by means of agreements between the competent authorities and the economic sectors concerned. Such agreements shall meet the following requirements: (a) agreements shall be enforceable; (b) agreements need to specify objectives with the corresponding deadlines; (c) agreements shall be published in the national official journal or an official document equally accessible to the public and transmitted to the Commission; (d) the results achieved under an agreement shall be monitored regularly, reported to the competent authorities and to the Commission and made available to the public under the conditions set out in the agreement; (e) the competent authorities shall make provisions to examine the progress reached under an agreement; and (f) in case of non-compliance with an agreement Member States shall implement the relevant provisions of this Directive by legislative, regulatory or administrative measures. Article 18 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 19 Addressees This Directive is addressed to the Member States. Done at Brussels, 5 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 62, 15.2.2019, p. 207. (2) OJ C 461, 21.12.2018, p. 210. (3) Position of the European Parliament of 27 March 2019 (not yet published in the Official Journal) and decision of the Council of 21 May 2019. (4) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). (5) OJ L 179, 23.6.1998, p. 3. (6) OJ L 39, 16.2.1993, p. 3. (7) Directive 2000/59/EC of the European Parliament and of the Council of 27 November 2000 on port reception facilities for ship-generated waste and cargo residues (OJ L 332, 28.12.2000, p. 81). (8) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (9) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (10) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (11) European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10). (12) Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1). (13) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). (14) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (15) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1). (16) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4). (17) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (18) Directive (EU) 2019/883 of the European Parliament and of the Council of 17 April 2019 on port reception facilities for the delivery of waste from ships, amending Directive 2010/65/EU and repealing Directive 2000/59/EC (OJ L 151, 7.6.2019, p. 116). (19) OJ L 123, 12.5.2016, p. 1. (20) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (21) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (22) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (23) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (24) Council Regulation (EC) No 850/98 of 30 March 1998 for the conservation of fishery resources through technical measures for the protection of juveniles of marine organisms (OJ L 125, 27.4.1998, p. 1). ANNEX PART A Single-use plastic products covered by Article 4 on consumption reduction (1) Cups for beverages, including their covers and lids; (2) Food containers, i.e. receptacles such as boxes, with or without a cover, used to contain food which: (a) is intended for immediate consumption, either on-the-spot or take-away, (b) is typically consumed from the receptacle, and (c) is ready to be consumed without any further preparation, such as cooking, boiling or heating, including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food. PART B Single-use plastic products covered by Article 5 on restrictions on placing on the market (1) Cotton bud sticks, except if they fall within the scope of Council Directive 90/385/EEC (1) or Council Directive 93/42/EEC (2); (2) Cutlery (forks, knives, spoons, chopsticks); (3) Plates; (4) Straws, except if they fall within the scope of Directive 90/385/EEC or Directive 93/42/EEC; (5) Beverage stirrers; (6) Sticks to be attached to and to support balloons, except balloons for industrial or other professional uses and applications that are not distributed to consumers, including the mechanisms of such sticks; (7) Food containers made of expanded polystyrene, i.e. receptacles such as boxes, with or without a cover, used to contain food which: (a) is intended for immediate consumption, either on-the-spot or take-away, (b) is typically consumed from the receptacle, and (c) is ready to be consumed without any further preparation, such as cooking, boiling or heating, including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food; (8) Beverage containers made of expanded polystyrene, including their caps and lids; (9) Cups for beverages made of expanded polystyrene, including their covers and lids. PART C Single-use plastic products covered by Article 6(1) to (4) on product requirements Beverage containers with a capacity of up to three litres, i.e. receptacles used to contain liquid, such as beverage bottles including their caps and lids and composite beverage packaging including their caps and lids, but not: (a) glass or metal beverage containers that have caps and lids made from plastic, (b) beverage containers intended and used for food for special medical purposes as defined in point (g) of Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the Council (3) that is in liquid form. PART D Single-use plastic products covered by Article 7 on marking requirements (1) Sanitary towels (pads), tampons and tampon applicators; (2) Wet wipes, i.e. pre-wetted personal care and domestic wipes; (3) Tobacco products with filters and filters marketed for use in combination with tobacco products; (4) Cups for beverages. PART E I. Single-use plastic products covered by Article 8(2) on extended producer responsibility (1) Food containers, i.e. receptacles such as boxes, with or without a cover, used to contain food which: (a) is intended for immediate consumption, either on-the-spot or take-away, (b) is typically consumed from the receptacle, and (c) is ready to be consumed without any further preparation, such as cooking, boiling or heating, including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food; (2) Packets and wrappers made from flexible material containing food that is intended for immediate consumption from the packet or wrapper without any further preparation; (3) Beverage containers with a capacity of up to three litres, i.e. receptacles used to contain liquid such as beverage bottles including their caps and lids and composite beverage packaging including their caps and lids, but not glass or metal beverage containers that have caps and lids made from plastic; (4) Cups for beverages, including their covers and lids; (5) Lightweight plastic carrier bags as defined in point 1c of Article 3 of Directive 94/62/EC. II. Single-use plastic products covered by Article 8(3) on extended producer responsibility (1) Wet wipes, i.e. pre-wetted personal care and domestic wipes; (2) Balloons, except balloons for industrial or other professional uses and applications that are not distributed to consumers. III. Other single-use plastic products covered by Article 8(3) on extended producer responsibility Tobacco products with filters and filters marketed for use in combination with tobacco products. PART F Single-use plastic products covered by Article 9 on separate collection and by Article 6(5) on product requirements Beverage bottles with a capacity of up to three litres, including their caps and lids, but not: (a) glass or metal beverage bottles that have caps and lids made from plastic, (b) beverage bottles intended and used for food for special medical purposes as defined in point (g) of Article 2 of Regulation (EU) No 609/2013 that is in liquid form. PART G Single-use plastic products covered by Article 10 on awareness raising (1) Food containers, i.e. receptacles such as boxes, with or without a cover, used to contain food which: (a) is intended for immediate consumption, either on-the-spot or take-away, (b) is typically consumed from the receptacle, and (c) is ready to be consumed without any further preparation, such as cooking, boiling or heating, including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food; (2) Packets and wrappers made from flexible material containing food that is intended for immediate consumption from the packet or wrapper without any further preparation; (3) Beverage containers with a capacity of up to three litres, i.e. receptacles used to contain liquid such as beverage bottles including their caps and lids and composite beverage packaging including their caps and lids, but not glass or metal beverage containers that have caps and lids made from plastic; (4) Cups for beverages, including their covers and lids; (5) Tobacco products with filters and filters marketed for use in combination with tobacco products; (6) Wet wipes, i.e. pre-wetted personal care and domestic wipes; (7) Balloons, except balloons for industrial or other professional uses and applications that are not distributed to consumers; (8) Lightweight plastic carrier bags as defined in point 1c of Article 3 of Directive 94/62/EC; (9) Sanitary towels (pads), tampons and tampon applicators. (1) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17). (2) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). (3) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).", "summary": "Single-use plastics ban Single-use plastics ban SUMMARY OF: Directive (EU) 2019/904 \u2014 on the reduction of the impact of certain plastic products on the environment WHAT IS THE AIM OF THE DIRECTIVE? It aims to prevent and reduce the impact on the environment of certain plastic products and to promote a transition to a circular economy by introducing a mix of measures tailored to the products covered by the directive, including an EU-wide ban on single-use plastic products whenever alternatives are available. The directive delivers on the EU\u2019s plastic strategy, an important element in the EU\u2019s move towards a circular economy. KEY POINTS Scope Single-use plastics are made wholly or partly of plastic and are typically intended to be used just once or for a short period of time before they are thrown away. Market restrictions (bans) The plastic products to be banned under the directive include: cutlery (forks, knives, spoons, chopsticks); plates; straws; cotton bud sticks; beverage stirrers; sticks to be attached to and to support balloons; food containers made of expanded polystyrene; products made from oxo-degradable plastic. Consumption reductions In line with the EU\u2019s waste policy, EU countries are required to: take measures to reduce the consumption of certain single-use plastics for which there is no alternative (drinking cups including covers and lids, and containers of prepared food for immediate consumption);monitor consumption of these single-use products as well as the measures taken and report the progress made to the European Commission. The directive requires an ambitious and sustained quantitative reduction in consumption of these products by 2026 (compared to a 2022 baseline). Separate collection and design requirements for plastic bottles The directive sets a collection target of 90% recycling for plastic bottles by 2029 (with an interim target of 77% by 2025). These bottles should contain at least 25% recycled plastic in their manufacture by 2025 (for PET bottles), and 30% by 2030 (for all bottles). Compulsory marking Certain disposable plastic products placed on the market must carry a visible, clearly legible and indelible marking affixed to its packaging or to the product itself: sanitary items; wet wipes; tobacco products with filters; and drinking cups. These labels should inform consumers about: appropriate waste management options for the product or what type of waste disposal should be avoided for the product; and the presence of plastics in the product as well as the negative environmental impact of littering. Extended producer responsibility The directive incorporates the \u2018polluter pays\u2019 principle. Producers will have to cover the costs of: waste management clean-up; data-gathering; as well as awareness raising for the following products: food and beverage containers,bottles,cups,packets and wrappers,light-weight carrier bags, andtobacco products with filters. For wet wipes and balloons, these obligations will apply with the exception of the collection costs. EU countries are also required to: ensure rules on extended producer responsibility (EPR) for fishing gear containing plastic are in place; and monitor and assess plastic fishing gear with a view to establishing EU-wide collection targets. Awareness raising EU countries must also take measures to: inform consumers and to encourage responsible consumer behavior in order to reduce litter from such products; make consumers aware of reusable alternative products and the impact of inappropriate disposal of single-use plastic waste on the sewage system. FROM WHEN DOES THE DIRECTIVE APPLY? It has to become law in the EU countries by 3 July 2021. The market restrictions and marking of product rules apply from 3 July 2021, while the product design requirements for bottles apply from 3 July 2024. The Extended producer responsibility measures apply from 31 December 2024. BACKGROUND For further information, see: Waste (European Commission). MAIN DOCUMENT Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (OJ L 155, 12.6.2019, pp. 1-19) RELATED DOCUMENTS Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain directives (OJ L 312, 22.11.2008, pp. 3-30) Successive amendments to Directive 2008/98/EC have been incorporated in the original text. This consolidated version is of documentary value only. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, pp. 10-23) See consolidated version. last update 16.09.2019"}
{"article": "30.4.2021 EN Official Journal of the European Union L 149/10 TRADE AND COOPERATION Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part PREAMBLE THE EUROPEAN UNION AND THE EUROPEAN ATOMIC ENERGY COMMUNITY AND THE UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND, 1. REAFFIRMING their commitment to democratic principles, to the rule of law, to human rights, to countering proliferation of weapons of mass destruction and to the fight against climate change, which constitute essential elements of this and supplementing agreements, 2. RECOGNISING the importance of global cooperation to address issues of shared interest, 3. RECOGNISING the importance of transparency in international trade and investment to the benefit of all stakeholders, 4. SEEKING to establish clear and mutually advantageous rules governing trade and investment between the Parties, 5. CONSIDERING that in order to guarantee the efficient management and correct interpretation and application of this Agreement and any supplementing agreement, as well as compliance with the obligations under those agreements, it is essential to establish provisions ensuring overall governance, in particular dispute settlement and enforcement rules that fully respect the autonomy of the respective legal orders of the Union and of the United Kingdom, as well as the United Kingdom's status as a country outside the European Union, 6. BUILDING upon their respective rights and obligations under the Marrakesh Agreement Establishing the World Trade Organization, done on 15 April 1994, and other multilateral and bilateral instruments of cooperation, 7. RECOGNISING the Parties' respective autonomy and rights to regulate within their territories in order to achieve legitimate public policy objectives such as the protection and promotion of public health, social services, public education, safety, the environment including climate change, public morals, social or consumer protection, animal welfare, privacy and data protection and the promotion and protection of cultural diversity, while striving to improve their respective high levels of protection, 8. BELIEVING in the benefits of a predictable commercial environment that fosters trade and investment between the Parties and prevents the distortion of trade and unfair competitive advantages, in a manner conducive to sustainable development in its economic, social and environmental dimensions, 9. RECOGNISING the need for an ambitious, wide-ranging and balanced economic partnership to be underpinned by a level playing field for open and fair competition and sustainable development, through effective and robust frameworks for subsidies and competition and a commitment to uphold their respective high levels of protection in the areas of labour and social standards, environment, the fight against climate change, and taxation, 10. RECOGNISING the need to ensure an open and secure market for businesses, including small and medium-sized enterprises, and their goods and services through addressing unjustified barriers to trade and investment, 11. NOTING the importance of facilitating new opportunities for businesses and consumers through digital trade, and addressing unjustified barriers to data flows and trade enabled by electronic means, whilst respecting the Parties' personal data protection rules, 12. DESIRING that this Agreement contribute to consumer welfare through policies ensuring a high level of consumer protection and economic well-being, as well as encouraging cooperation between relevant authorities, 13. CONSIDERING the importance of cross-border connectivity by air, by road and by sea, for passengers and for goods, and the need to ensure high standards in the provision of transportation services between the Parties, 14. RECOGNISING the benefits of trade and investment in energy and raw materials and the importance of supporting the delivery of cost efficient, clean and secure energy supplies to the Union and the United Kingdom, 15. NOTING the interest of the Parties in establishing a framework to facilitate technical cooperation and to develop new trading arrangements for interconnectors which deliver robust and efficient outcomes for all timeframes, 16. NOTING that cooperation and trade between the Parties in these areas should be based on fair competition in energy markets and non-discriminatory access to networks, 17. RECOGNISING the benefits of sustainable energy, renewable energy, in particular offshore generation in the North Sea, and energy efficiency, 18. DESIRING to promote the peaceful use of the waters adjacent to their coasts and the optimum and equitable utilisation of the marine living resources in those waters including the continued sustainable management of shared stocks, 19. NOTING that the United Kingdom withdrew from the European Union and that with effect from 1 January 2021, the United Kingdom is an independent coastal State with corresponding rights and obligations under international law, 20. AFFIRMING that the sovereign rights of the coastal States exercised by the Parties for the purpose of exploring, exploiting, conserving and managing the living resources in their waters should be conducted pursuant to and in accordance with the principles of international law, including the United Nations Convention on the Law of the Sea, done at Montego Bay on 10 December 1982 (United Nations Convention on the Law of the Sea), 21. RECOGNISING the importance of the coordination of social security rights enjoyed by persons moving between the Parties to work, to stay or to reside, as well as the rights enjoyed by their family members and survivors, 22. CONSIDERING that cooperation in areas of shared interest, such as science, research and innovation, nuclear research and space, in the form of the participation of the United Kingdom in the corresponding Union programmes under fair and appropriate conditions will benefit both Parties, 23. CONSIDERING that cooperation between the United Kingdom and the Union relating to the prevention, investigation, detection or prosecution of criminal offences and to the execution of criminal penalties, including the safeguarding against and prevention of threats to public security, will enable the security of the United Kingdom and the Union to be strengthened, 24. DESIRING that an agreement is concluded between the United Kingdom and the Union to provide a legal base for such cooperation, 25. ACKNOWLEDGING that the Parties may supplement this Agreement with other agreements forming an integral part of their overall bilateral relations as governed by this Agreement and that the Agreement on Security Procedures for Exchanging and Protecting Classified Information is concluded as such a supplementing agreement and enables the exchange of classified information between the Parties under this Agreement or any other supplementing agreement, HAVE AGREED AS FOLLOWS: PART ONE COMMON AND INSTITUTIONAL PROVISIONS TITLE I GENERAL PROVISIONS Article 1 Purpose This Agreement establishes the basis for a broad relationship between the Parties, within an area of prosperity and good neighbourliness characterised by close and peaceful relations based on cooperation, respectful of the Parties' autonomy and sovereignty. Article 2 Supplementing agreements 1. Where the Union and the United Kingdom conclude other bilateral agreements between them, such agreements shall constitute supplementing agreements to this Agreement, unless otherwise provided for in those agreements. Such supplementing agreements shall be an integral part of the overall bilateral relations as governed by this Agreement and shall form part of the overall framework. 2. Paragraph 1 also applies to: (a) agreements between the Union and its Member States, of the one part, and the United Kingdom, of the other part; and (b) agreements between the European Atomic Energy Community, of the one part, and the United Kingdom, of the other part. Article 3 Good faith 1. The Parties shall, in full mutual respect and good faith, assist each other in carrying out tasks that flow from this Agreement and any supplementing agreement. 2. They shall take all appropriate measures, whether general or particular, to ensure the fulfilment of the obligations arising from this Agreement and from any supplementing agreement, and shall refrain from any measures which could jeopardise the attainment of the objectives of this Agreement or any supplementing agreement. TITLE II PRINCIPLES OF INTERPRETATION AND DEFINITIONS Article 4 Public international law 1. The provisions of this Agreement and any supplementing agreement shall be interpreted in good faith in accordance with their ordinary meaning in their context and in light of the object and purpose of the agreement in accordance with customary rules of interpretation of public international law, including those codified in the Vienna Convention on the Law of Treaties, done at Vienna on 23 May 1969. 2. For greater certainty, neither this Agreement nor any supplementing agreement establishes an obligation to interpret their provisions in accordance with the domestic law of either Party. 3. For greater certainty, an interpretation of this Agreement or any supplementing agreement given by the courts of either Party shall not be binding on the courts of the other Party. Article 5 Private rights 1. Without prejudice to Article SSC.67 of the Protocol on Social Security Coordination and with the exception, with regard to the Union, of Part Three of this Agreement, nothing in this Agreement or any supplementing agreement shall be construed as conferring rights or imposing obligations on persons other than those created between the Parties under public international law, nor as permitting this Agreement or any supplementing agreement to be directly invoked in the domestic legal systems of the Parties. 2. A Party shall not provide for a right of action under its law against the other Party on the ground that the other Party has acted in breach of this Agreement or any supplementing agreement. Article 6 Definitions 1. For the purposes of this Agreement and any supplementing agreement, and unless otherwise specified, the following definitions apply: (a) \"data subject\" means an identified or identifiable natural person; an identifiable person being a person who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data or an online identifier, or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person; (b) \"day\" means a calendar day; (c) \"Member State\" means a Member State of the European Union; (d) \"personal data\" means any information relating to a data subject; (e) \"State\" means a Member State or the United Kingdom, as the context requires; (f) \"territory\" of a Party means in respect of each Party the territories to which this Agreement applies in accordance with Article 774; (g) \"the transition period\" means the transition period provided for in Article 126 of the Withdrawal Agreement; and (h) \"Withdrawal Agreement\" means the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, including its Protocols. 2. Any reference to the \"Union\", \"Party\" or \"Parties\" in this Agreement or any supplementing agreement shall be understood as not including the European Atomic Energy Community, unless otherwise specified or where the context otherwise requires. TITLE III INSTITUTIONAL FRAMEWORK Article 7 Partnership Council 1. A Partnership Council is hereby established. It shall comprise representatives of the Union and of the United Kingdom. The Partnership Council may meet in different configurations depending on the matters under discussion. 2. The Partnership Council shall be co-chaired by a Member of the European Commission and a representative of the Government of the United Kingdom at ministerial level. It shall meet at the request of the Union or the United Kingdom, and, in any event, at least once a year, and shall set its meeting schedule and its agenda by mutual consent. 3. The Partnership Council shall oversee the attainment of the objectives of this Agreement and any supplementing agreement. It shall supervise and facilitate the implementation and application of this Agreement and of any supplementing agreement. Each Party may refer to the Partnership Council any issue relating to the implementation, application and interpretation of this Agreement or of any supplementing agreement. 4. The Partnership Council shall have the power to: (a) adopt decisions in respect of all matters where this Agreement or any supplementing agreement so provides; (b) make recommendations to the Parties regarding the implementation and application of this Agreement or of any supplementing agreement; (c) adopt, by decision, amendments to this Agreement or to any supplementing agreement in the cases provided for in this Agreement or in any supplementing agreement; (d) except in relation to Title III of Part One, until the end of the fourth year following the entry into force of this Agreement, adopt decisions amending this Agreement or any supplementing agreement, provided that such amendments are necessary to correct errors, or to address omissions or other deficiencies; (e) discuss any matter related to the areas covered by this Agreement or by any supplementing agreement; (f) delegate certain of its powers to the Trade Partnership Committee or to a Specialised Committee, except those powers and responsibilities referred to in point (g) of this paragraph; (g) by decision, establish Trade Specialised Committees and Specialised Committees, other than those referred to in Article 8(1), dissolve any Trade Specialised Committee or Specialised Committee, or change the tasks assigned to them; and (h) make recommendations to the Parties regarding the transfer of personal data in specific areas covered by this Agreement or any supplementing agreement. 5. The work of the Partnership Council shall be governed by the rules of procedure set out in Annex 1. The Partnership Council may amend that Annex. Article 8 Committees 1. The following Committees are hereby established: (a) the Trade Partnership Committee, which addresses matters covered by Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of Heading One of Part Two, Heading Six of Part Two, and Annex 27; (b) the Trade Specialised Committee on Goods which addresses matters covered by Chapter 1 of Title I of Heading One of Part Two and Chapter 4 of Title VIII of Heading One of Part Two; (c) the Trade Specialised Committee on Customs Cooperation and Rules of Origin, which addresses matters covered by Chapters 2 and 5 of Title I of Heading One of Part Two, the Protocol on mutual administrative assistance in customs matters and the provisions on customs enforcement of intellectual property rights, fees and charges, customs valuation and repaired goods; (d) the Trade Specialised Committee on Sanitary and Phytosanitary Measures, which addresses matters covered by Chapter 3 of Title I of Heading One of Part Two; (e) the Trade Specialised Committee on Technical Barriers to Trade, which addresses matters covered by Chapter 4 of Title I of Heading One of Part Two and Article 323; (f) the Trade Specialised Committee on Services, Investment and Digital Trade, which addresses matters covered by Titles II to IV of Heading One of Part Two and Chapter 4 of Title VIII of Heading One of Part Two; (g) the Trade Specialised Committee on Intellectual Property, which addresses matters covered by Title V of Heading One of Part Two; (h) the Trade Specialised Committee on Public Procurement, which addresses matters covered by Title VI of Heading One of Part Two; (i) the Trade Specialised Committee on Regulatory Cooperation, which addresses matters covered by Title X of Heading One of Part Two; (j) the Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development, which addresses matters covered by Title XI of Heading One of Part Two and Annex 27; (k) the Trade Specialised Committee on Administrative Cooperation in VAT and Recovery of Taxes and Duties, which addresses matters covered by the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties; (l) the Specialised Committee on Energy, (i) which addresses matters covered by Title VIII of Heading One of Part Two, with the exception of Chapter 4, Article 323 and Annex 27, and (ii) which can discuss and provide expertise to the relevant Trade Specialised Committee on matters pertaining to Chapter 4 and Article 323; (m) the Specialised Committee on Air Transport, which addresses matters covered by Title I of Heading Two of Part Two; (n) the Specialised Committee on Aviation Safety, which addresses matters covered by Title II of Heading Two of Part Two; (o) the Specialised Committee on Road Transport, which addresses matters covered by Heading Three of Part Two; (p) the Specialised Committee on Social Security Coordination, which addresses matters covered by Heading Four of Part Two and the Protocol on Social Security Coordination; (q) the Specialised Committee on Fisheries, which addresses matters covered by Heading Five of Part Two; (r) the Specialised Committee on Law Enforcement and Judicial Cooperation, which addresses matters covered by Part Three; and (s) the Specialised Committee on Participation in Union Programmes, which addresses matters covered by Part Five. 2. With respect to issues related to Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of Heading One of Part Two, Heading Six of Part Two and Annex 27, the Trade Partnership Committee referred to in paragraph 1 of this Article shall have the power to: (a) assist the Partnership Council in the performance of its tasks and, in particular, report to the Partnership Council and carry out any task assigned to it by the latter; (b) supervise the implementation of this Agreement or any supplementing agreement; (c) adopt decisions or make recommendations as provided for in this Agreement or any supplementing agreement or where such power has been delegated to it by the Partnership Council; (d) supervise the work of the Trade Specialised Committees referred to in paragraph 1 of this Article; (e) explore the most appropriate way to prevent or solve any difficulty that may arise in relation to the interpretation and application of this Agreement or any supplementing agreement, without prejudice to Title I of Part Six; (f) exercise the powers delegated to it by the Partnership Council pursuant to point (f) of Article 7(4); (g) establish, by decision, Trade Specialised Committees other than those referred to in paragraph 1 of this Article, dissolve any such Trade Specialised Committee, or change the tasks assigned to them; and (h) establish, supervise, coordinate and dissolve Working Groups, or delegate their supervision to a Trade Specialised Committee. 3. With respect to issues related to their area of competence, Trade Specialised Committees shall have the power to: (a) monitor and review the implementation and ensure the proper functioning of this Agreement or any supplementing agreement; (b) assist the Trade Partnership Committee in the performance of its tasks and, in particular, report to the Trade Partnership Committee and carry out any task assigned to them by it; (c) conduct the preparatory technical work necessary to support the functions of the Partnership Council and the Trade Partnership Committee, including when those bodies have to adopt decisions or recommendations; (d) adopt decisions in respect of all matters where this Agreement or any supplementing agreement so provides; (e) discuss technical issues arising from the implementation of this Agreement or of any supplementing agreement, without prejudice to Title I of Part Six; and (f) provide a forum for the Parties to exchange information, discuss best practices and share implementation experience. 4. With respect to issues related to their area of competence, Specialised Committees shall have the power to: (a) monitor and review the implementation and ensure the proper functioning of this Agreement or any supplementing agreement; (b) assist the Partnership Council in the performance of its tasks and, in particular, report to the Partnership Council and carry out any task assigned to them by it; (c) adopt decisions, including amendments, and recommendations in respect of all matters where this Agreement or any supplementing agreement so provides or for which the Partnership Council has delegated its powers to a Specialised Committee in accordance with point (f) of Article 7(4); (d) discuss technical issues arising from the implementation of this Agreement or any supplementing agreement; (e) provide a forum for the Parties to exchange information, discuss best practices and share implementation experience; (f) establish, supervise, coordinate and dissolve Working Groups; and (g) provide a forum for consultation pursuant to Article 738(7). 5. Committees shall comprise representatives of each Party. Each Party shall ensure that its representatives on the Committees have the appropriate expertise with respect to the issues under discussion. 6. The Trade Partnership Committee shall be co-chaired by a senior representative of the Union and a representative of the United Kingdom with responsibility for trade-related matters, or their designees. It shall meet at the request of the Union or the United Kingdom, and, in any event, at least once a year, and shall set its meeting schedule and its agenda by mutual consent. 7. The Trade Specialised Committees and the Specialised Committees shall be co-chaired by a representative of the Union and a representative of the United Kingdom. Unless otherwise provided for in this Agreement, or unless the co-chairs decide otherwise, they shall meet at least once a year. 8. Committees shall set their meeting schedule and agenda by mutual consent. 9. The work of the Committees shall be governed by the rules of procedure set out in Annex 1. 10. By way of derogation from paragraph 9, a Committee may adopt and subsequently amend its own rules that shall govern its work. Article 9 Working Groups 1. The following Working Groups are hereby established: (a) the Working Group on Organic Products, under the supervision of the Trade Specialised Committee on Technical Barriers to Trade; (b) the Working Group on Motor Vehicles and Parts, under the supervision of the Trade Specialised Committee on Technical Barriers to Trade; (c) the Working Group on Medicinal Products, under the supervision of the Trade Specialised Committee on Technical Barriers to Trade; (d) the Working Group on Social Security Coordination, under the supervision of the Specialised Committee on Social Security Coordination. 2. Working Groups shall, under the supervision of Committees, assist Committees in the performance of their tasks and, in particular, prepare the work of Committees and carry out any task assigned to them by the latter. 3. Working Groups shall comprise representatives of the Union and of the United Kingdom and shall be co-chaired by a representative of the Union and a representative of the United Kingdom. 4. Working Groups shall set their own rules of procedure, meeting schedule and agenda by mutual consent. Article 10 Decisions and recommendations 1. The decisions adopted by the Partnership Council, or, as the case may be, by a Committee, shall be binding on the Parties and on all the bodies set up under this Agreement and under any supplementing agreement, including the arbitration tribunal referred to in Title I of Part Six. Recommendations shall have no binding force. 2. The Partnership Council or, as the case may be, a Committee, shall adopt decisions and make recommendations by mutual consent. Article 11 Parliamentary cooperation 1. The European Parliament and the Parliament of the United Kingdom may establish a Parliamentary Partnership Assembly consisting of Members of the European Parliament and of Members of the Parliament of the United Kingdom, as a forum to exchange views on the partnership. 2. Upon its establishment, the Parliamentary Partnership Assembly: (a) may request relevant information regarding the implementation of this Agreement and any supplementing agreement from the Partnership Council, which shall then supply that Assembly with the requested information; (b) shall be informed of the decisions and recommendations of the Partnership Council; and (c) may make recommendations to the Partnership Council. Article 12 Participation of civil society The Parties shall consult civil society on the implementation of this Agreement and any supplementing agreement, in particular through interaction with the domestic advisory groups and the Civil Society Forum referred to in Articles 13 and 14. Article 13 Domestic advisory groups 1. Each Party shall consult on issues covered by this Agreement and any supplementing agreement its newly created or existing domestic advisory group or groups comprising a representation of independent civil society organisations including non-governmental organisations, business and employers' organisations, as well as trade unions, active in economic, sustainable development, social, human rights, environmental and other matters. Each Party may convene its domestic advisory group or groups in different configurations to discuss the implementation of different provisions of this Agreement or of any supplementing agreement. 2. Each Party shall consider views or recommendations submitted by its domestic advisory group or groups. Representatives of each Party shall aim to consult with their respective domestic advisory group or groups at least once a year. Meetings may be held by virtual means. 3. In order to promote public awareness of the domestic advisory groups, each Party shall endeavour to publish the list of organisations participating in its domestic advisory group or groups as well as the contact point for that or those groups. 4. The Parties shall promote interaction between their respective domestic advisory groups, including by exchanging where possible the contact details of members of their domestic advisory groups. Article 14 Civil Society Forum 1. The Parties shall facilitate the organisation of a Civil Society Forum to conduct a dialogue on the implementation of Part Two. The Partnership Council shall adopt operational guidelines for the conduct of the Forum. 2. The Civil Society Forum shall meet at least once a year, unless otherwise agreed by the Parties. The Civil Society Forum may meet by virtual means. 3. The Civil Society Forum shall be open for the participation of independent civil society organisations established in the territories of the Parties, including members of the domestic advisory groups referred to in Article 13. Each Party shall promote a balanced representation, including non-governmental organisations, business and employers' organisations and trade unions, active in economic, sustainable development, social, human rights, environmental and other matters. PART TWO TRADE, TRANSPORT, FISHERIES AND OTHER ARRANGEMENTS HEADING ONE TRADE TITLE I TRADE IN GOODS CHAPTER 1 NATIONAL TREATMENT AND MARKET ACCESS FOR GOODS (INCLUDING TRADE REMEDIES) Article 15 Objective The objective of this Chapter is to facilitate trade in goods between the Parties and to maintain liberalised trade in goods in accordance with the provisions of this Agreement. Article 16 Scope Except as otherwise provided, this Chapter applies to trade in goods of a Party. Article 17 Definitions For the purposes of this Chapter, the following definitions apply: (a) \"consular transactions\" means the procedure of obtaining from a consul of the importing Party in the territory of the exporting Party, or in the territory of a third party, a consular invoice or a consular visa for a commercial invoice, certificate of origin, manifest, shipper's export declaration or any other customs documentation in connection with the importation of the good; (b) \"Customs Valuation Agreement\" means the Agreement on Implementation of Article VII of GATT 1994; (c) \"export licensing procedure\" means an administrative procedure, whether or not referred to as licensing, used by a Party for the operation of export licensing regimes, requiring the submission of an application or other documentation, other than that generally required for customs clearance purposes, to the relevant administrative body as a prior condition for exportation from that Party; (d) \"import licensing procedure\" means an administrative procedure, whether or not referred to as licensing, used by a Party for the operation of import licensing regimes, requiring the submission of an application or other documentation, other than that generally required for customs clearance purposes, to the relevant administrative body or bodies as a prior condition for importation into the territory of the importing Party; (e) \"originating goods\" means, unless otherwise provided, a good qualifying under the rules of origin set out in Chapter 2 of this Title; (f) \"performance requirement\" means a requirement that: (i) a given quantity, value or percentage of goods be exported; (ii) goods of the Party granting an import licence be substituted for imported goods; (iii) a person benefiting from an import licence purchase other goods in the territory of the Party granting the import licence, or accord a preference to domestically produced goods; (iv) a person benefiting from an import licence produce goods in the territory of the Party granting the import licence, with a given quantity, value or percentage of domestic content; or (v) relates in whatever form to the volume or value of imports, to the volume or value of exports or to the amount of foreign exchange flows; (g) \"remanufactured good\" means a good classified under HS Chapters 32, 40, 84 to 90, 94 or 95 that: (i) is entirely or partially composed of parts obtained from used goods; (ii) has similar life expectancy and performance compared with such goods, when new; and (iii) is given an equivalent warranty to as that applicable to such goods when new; and (h) \"repair\" means any processing operation undertaken on a good to remedy operating defects or material damage and entailing the re-establishment of the good to its original function or to ensure compliance with technical requirements for its use. Repair of a good includes restoration and maintenance, with a possible increase in the value of the good from restoring the original functionality of that good, but does not include an operation or process that: (i) destroys the essential characteristics of a good, or creates a new or commercially different good; (ii) transforms an unfinished good into a finished good; or (iii) is used to improve or upgrade the technical performance of a good. Article 18 Classification of goods The classification of goods in trade between the Parties under this Agreement is set out in each Party's respective tariff nomenclature in conformity with the Harmonised System. Article 19 National treatment on internal taxation and regulation Each Party shall accord national treatment to the goods of the other Party in accordance with Article III of GATT 1994 including its Notes and Supplementary Provisions. To that end, Article III of GATT 1994 and its Notes and Supplementary Provisions are incorporated into and made part of this Agreement, mutatis mutandis. Article 20 Freedom of transit Each Party shall accord freedom of transit through its territory, via the routes most convenient for international transit, for traffic in transit to or from the territory of the other Party or of any other third country. To that end, Article V of GATT 1994 and its Notes and Supplementary Provisions are incorporated into and made part of this Agreement, mutatis mutandis. The Parties understand that Article V of GATT 1994 includes the movement of energy goods via inter alia pipelines or electricity grids. Article 21 Prohibition of customs duties Except as otherwise provided for in this Agreement, customs duties on all goods originating in the other Party shall be prohibited. Article 22 Export duties, taxes or other charges 1. A Party may not adopt or maintain any duty, tax or other charge of any kind imposed on, or in connection with, the exportation of a good to the other Party; or any internal tax or other charge on a good exported to the other Party that is in excess of the tax or charge that would be imposed on like goods when destined for domestic consumption. 2. For the purpose of this Article the term \"other charge of any kind\" does not include fees or other charges that are permitted under Article 23. Article 23 Fees and formalities 1. Fees and other charges imposed by a Party on or in connection with importation or exportation of a good of the other Party shall be limited in amount to the approximate cost of the services rendered, and shall not represent an indirect protection to domestic goods or taxation of imports or exports for fiscal purposes. A Party shall not levy fees or other charges on or in connection with importation or exportation on an ad valorem basis. 2. Each Party may impose charges or recover costs only where specific services are rendered, in particular, but not limited to, the following: (a) attendance, where requested, by customs staff outside official office hours or at premises other than customs premises; (b) analyses or expert reports on goods and postal fees for the return of goods to an applicant, particularly in respect of decisions relating to binding information or the provision of information concerning the application of the customs laws and regulations; (c) the examination or sampling of goods for verification purposes, or the destruction of goods, where costs other than the cost of using customs staff are involved; and (d) exceptional control measures, if these are necessary due to the nature of the goods or to a potential risk. 3. Each Party shall promptly publish all fees and charges it imposes in connection with importation or exportation via an official website in such a manner as to enable governments, traders and other interested parties, to become acquainted with them. That information shall include the reason for the fee or charge for the service provided, the responsible authority, the fees and charges that will be applied, and when and how payment is to be made. New or amended fees and charges shall not be imposed until information in accordance with this paragraph has been published and made readily available. 4. A Party shall not require consular transactions, including related fees and charges, in connection with the importation of any good of the other Party. Article 24 Repaired goods 1. A Party shall not apply a customs duty to a good, regardless of its origin, that re-enters the Party's territory after that good has been temporarily exported from its territory to the territory of the other Party for repair. 2. Paragraph 1 does not apply to a good imported in bond, into free trade zones, or in similar status, that is then exported for repair and is not re-imported in bond, into free trade zones, or in similar status. 3. A Party shall not apply a customs duty to a good, regardless of its origin, imported temporarily from the territory of the other Party for repair. Article 25 Remanufactured goods 1. A Party shall not accord to remanufactured goods of the other Party treatment that is less favourable than that which it accords to equivalent goods in new condition. 2. Article 26 applies to import and export prohibitions or restrictions on remanufactured goods. If a Party adopts or maintains import and export prohibitions or restrictions on used goods, it shall not apply those measures to remanufactured goods. 3. A Party may require that remanufactured goods be identified as such for distribution or sale in its territory and that they meet all applicable technical requirements that apply to equivalent goods in new condition. Article 26 Import and export restrictions 1. A Party shall not adopt or maintain any prohibition or restriction on the importation of any good of the other Party or on the exportation or sale for export of any good destined for the territory of the other Party, except in accordance with Article XI of GATT 1994, including its Notes and Supplementary Provisions. To that end, Article XI of GATT 1994 and its Notes and Supplementary Provisions are incorporated into and made part of this Agreement, mutatis mutandis. 2. A Party shall not adopt or maintain: (a) export and import price requirements, except as permitted in enforcement of countervailing and anti-dumping duty orders and undertakings; or (b) import licensing conditioned on the fulfilment of a performance requirement. Article 27 Import and export monopolies A Party shall not designate or maintain an import or export monopoly. For the purposes of this Article, import or export monopoly means the exclusive right or grant of authority by a Party to an entity to import a good from, or export a good to, the other Party. Article 28 Import licensing procedures 1. Each Party shall ensure that all import licensing procedures applicable to trade in goods between the Parties are neutral in application, and are administered in a fair, equitable, non-discriminatory and transparent manner. 2. A Party shall only adopt or maintain licensing procedures as a condition for importation into its territory from the territory of the other Party, if other appropriate procedures to achieve an administrative purpose are not reasonably available. 3. A Party shall not adopt or maintain any non-automatic import licensing procedure, unless it is necessary to implement a measure that is consistent with this Agreement. A Party adopting such non-automatic import licensing procedure shall indicate clearly the measure being implemented through that procedure. 4. Each Party shall introduce and administer any import licensing procedure in accordance with Articles 1 to 3 of the WTO Agreement on Import Licensing Procedures (the \"Import Licensing Agreement\"). To that end, Articles 1 to 3 of the Import Licensing Agreement are incorporated into and made part of this Agreement mutatis mutandis. 5. Any Party introducing or modifying any import licensing procedure shall make all relevant information available online on an official website. That information shall be made available, whenever practicable, at least 21 days prior to the date of the application of the new or modified licensing procedure and in any event no later than the date of application. That information shall contain the data required under Article 5 of the Import Licensing Agreement. 6. At the request of the other Party, a Party shall promptly provide any relevant information regarding any import licensing procedures that it intends to adopt or that it maintains, including the information referred to in Articles 1 to 3 of the Import Licensing Agreement. 7. For greater certainty, nothing in this Article requires a Party to grant an import licence, or prevents a Party from implementing its obligations or commitments under United Nations Security Council Resolutions or under multilateral non-proliferation regimes and import control arrangements. Article 29 Export licensing procedures 1. Each Party shall publish any new export licensing procedure, or any modification to an existing export licensing procedure, in such a manner as to enable governments, traders and other interested parties to become acquainted with them. Such publication shall take place, whenever practicable, 45 days before the procedure or modification takes effect, and in any case no later than the date such procedure or modification takes effect and, where appropriate, publication shall take place on any relevant government websites. 2. The publication of export licensing procedures shall include the following information: (a) the texts of the Party's export licensing procedures, or of any modifications the Party makes to those procedures; (b) the goods subject to each licensing procedure; (c) for each procedure, a description of the process for applying for a licence and any criteria an applicant must meet to be eligible to apply for a licence, such as possessing an activity licence, establishing or maintaining an investment, or operating through a particular form of establishment in a Party's territory; (d) a contact point or points from which interested persons can obtain further information on the conditions for obtaining an export licence; (e) the administrative body or bodies to which an application or other relevant documentation are to be submitted; (f) a description of any measure or measures being implemented through the export licensing procedure; (g) the period during which each export licensing procedure will be in effect, unless the procedure remains in effect until withdrawn or revised in a new publication; (h) if the Party intends to use a licensing procedure to administer an export quota, the overall quantity and, if applicable, the value of the quota and the opening and closing dates of the quota; and (i) any exemptions or exceptions that replace the requirement to obtain an export licence, how to request or use those exemptions or exceptions, and the criteria for granting them. 3. Within 45 days after the date of entry into force of this Agreement, each Party shall notify the other Party of its existing export licensing procedures. Each Party shall notify to the other Party any new export licensing procedures and any modifications to existing export licensing procedures within 60 days of publication. The notification shall include a reference to the sources where the information required pursuant to paragraph 2 is published and shall include, where appropriate, the address of the relevant government websites. 4. For greater certainty, nothing in this Article requires a Party to grant an export licence, or prevents a Party from implementing its commitments under United Nations Security Council Resolutions as well as under multilateral non-proliferation regimes and export control arrangements including the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies, the Australia Group, the Nuclear Suppliers Group, and the Missile Technology Control Regime, or from adopting, maintaining or implementing independent sanctions regimes. Article 30 Customs valuation Each Party shall determine the customs value of goods of the other Party imported into its territory in accordance with Article VII of GATT 1994 and the Customs Valuation Agreement. To that end, Article VII of GATT 1994 including its Notes and Supplementary Provisions, and Articles 1 to 17 of the Customs Valuation Agreement including its Interpretative Notes, are incorporated into and made part of this Agreement, mutatis mutandis. Article 31 Preference utilisation 1. For the purpose of monitoring the functioning of this Agreement and calculating preference utilisation rates, the Parties shall annually exchange import statistics for a 10 year-long period starting one year after the entry into force of this Agreement. Unless the Trade Partnership Committee decides otherwise, this period shall be automatically extended for five years, and thereafter the Trade Partnership Committee may decide to extend it further. 2. The exchange of import statistics shall cover data pertaining to the most recent year available, including value and, where applicable, volume, at the tariff line level for imports of goods of the other Party benefitting from preferential duty treatment under this Agreement and for those that receive non-preferential treatment. Article 32 Trade remedies 1. The Parties affirm their rights and obligations under Article VI of GATT 1994, the Anti-Dumping Agreement, the SCM Agreement, Article XIX of GATT 1994, the Safeguards Agreement, and Article 5 of the Agreement on Agriculture. 2. Chapter 2 of this Title does not apply to anti-dumping, countervailing and safeguard investigations and measures. 3. Each Party shall apply anti-dumping and countervailing measures in accordance with the requirements of the Anti-Dumping Agreement and the SCM Agreement, and pursuant to a fair and transparent process. 4. Provided it does not unnecessarily delay the conduct of the investigation, each interested party in an anti-dumping or countervailing investigation (1) shall be granted a full opportunity to defend its interests. 5. Each Party's investigating authority may, in accordance with the Party's law, consider whether the amount of the anti-dumping duty to be imposed shall be the full margin of dumping or a lesser amount. 6. Each Party's investigating authority shall, in accordance with the Party's law, consider information provided as to whether imposing an anti-dumping or a countervailing duty would not be in the public interest. 7. A Party shall not apply or maintain, with respect to the same good, at the same time: (a) a measure pursuant to Article 5 of the Agreement on Agriculture; and (b) a measure pursuant to Article XIX of GATT 1994 and the Safeguards Agreement. 8. Title I of Part Six does not apply to paragraphs 1 to 6 of this Article. Article 33 Use of existing WTO tariff rate quotas 1. Products originating in one Party shall not be eligible to be imported into the other Party under existing WTO Tariff Rate Quotas (\"TRQs\") as defined in paragraph 2. This shall include those TRQs as being apportioned between the Parties pursuant to Article XXVIII GATT negotiations initiated by the European Union in WTO document G/SECRET/42/Add.2 and by the United Kingdom in WTO document G/SECRET/44 and as set out in each Party's respective internal legislation. For the purposes of this Article, the originating status of the products shall be determined on the basis of non-preferential rules of origin applicable in the importing Party. 2. For the purposes of paragraph 1, \"existing WTO TRQs\" means those tariff rate quotas which are WTO concessions of the European Union included in the draft EU28 schedule of concessions and commitments under GATT 1994 submitted to the WTO in document G/MA/TAR/RS/506 as amended by documents G/MA/TAR/RS/506/Add.1 and G/MA/TAR/RS/506/Add.2. Article 34 Measures in case of breaches or circumventions of customs legislation 1. The Parties shall cooperate in preventing, detecting and combating breaches or circumventions of customs legislation, in accordance with their obligations under Chapter 2 of this Title and the Protocol on mutual administrative assistance in customs matters. Each Party shall take appropriate and comparable measures to protect its own and the other Party's financial interests regarding the levying of duties on goods entering the customs territories of the United Kingdom or the Union. 2. Subject to the possibility of exemption for compliant traders under paragraph 7, a Party may temporarily suspend the relevant preferential treatment of the product or products concerned in accordance with the procedure laid down in paragraphs 3 and 4 if: (a) that Party has made a finding, based on objective, compelling and verifiable information, that systematic and large-scale breaches or circumventions of customs legislation have been committed, and; (b) the other Party repeatedly and unjustifiably refuses or otherwise fails to comply with the obligations referred to in paragraph 1. 3. The Party which has made a finding as referred to in paragraph 2 shall notify the Trade Partnership Committee and shall enter into consultations with the other Party within the Trade Partnership Committee with a view to reaching a mutually acceptable solution. 4. If the Parties fail to agree on a mutually acceptable solution within three months after the date of notification, the Party which has made the finding may decide to suspend temporarily the relevant preferential treatment of the product or products concerned. In this case, the Party which made the finding shall notify the temporary suspension, including the period during which it intends the temporary suspension to apply, to the Trade Partnership Committee without delay. 5. The temporary suspension shall apply only for the period necessary to counteract the breaches or circumventions and to protect the financial interests of the Party concerned, and in any case not for longer than six months. The Party concerned shall keep the situation under review and, where it decides that the temporary suspension is no longer necessary, it shall bring it to an end before the end of the period notified to the Trade Partnership Committee. Where the conditions that gave rise to the suspension persist at the expiry of the period notified to the Trade Partnership Committee, the Party concerned may decide to renew the suspension. Any suspension shall be subject to periodic consultations within the Trade Partnership Committee. 6. Each Party shall publish, in accordance with its internal procedures, notices to importers about any decision concerning temporary suspensions referred to in paragraphs 4 and 5. 7. Notwithstanding paragraph 4, if an importer is able to satisfy the importing customs authority that such products are fully compliant with the importing Party's customs legislation, the requirements of this Agreement, and any other appropriate conditions related to the temporary suspension established by the importing Party in accordance with its laws and regulations, the importing Party shall allow the importer to apply for preferential treatment and recover any duties paid in excess of the applicable preferential tariff rates when the products were imported. Article 35 Management of administrative errors In case of systematic errors by the competent authorities or issues concerning the proper management of the preferential system at export, concerning notably the application of the provisions of Chapter 2 of this Title or the application of the Protocol on Mutual Administrative Assistance in Customs Matters, and if these errors or issues lead to consequences in terms of import duties, the Party facing such consequences may request the Trade Partnership Committee to examine the possibility of adopting decisions, as appropriate, to resolve the situation. Article 36 Cultural property 1. The Parties shall cooperate in facilitating the return of cultural property illicitly removed from the territory of a Party, having regard to the principles enshrined in the UNESCO Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property signed in Paris on 17 November 1970. 2. For the purposes of this Article, the following definitions apply: (a) \"cultural property\" means property classified or defined as being among the national treasures possessing artistic, historic or archaeological value under the respective rules and procedures of each Party; and (b) \"illicitly removed from the territory of a Party\" means: (i) removed from the territory of a Party on or after 1 January 1993 in breach of that Party's rules on the protection of national treasures or in breach of its rules on the export of cultural property; or (ii) not returned at the end of a period of lawful temporary removal or any breach of another condition governing such temporary removal, on or after 1 January 1993. 3. The competent authorities of the Parties shall cooperate with each other in particular by: (a) notifying the other Party where cultural property is found in their territory and there are reasonable grounds for believing that the cultural property has been illicitly removed from the territory of the other Party; (b) addressing requests of the other Party for the return of cultural property which has been illicitly removed from the territory of that Party; (c) preventing any actions to evade the return of such cultural property, by means of any necessary interim measures; and (d) taking any necessary measures for the physical preservation of cultural property which has been illicitly removed from the territory of the other Party. 4. Each Party shall identify a contact point responsible for communicating with the contact point of the other Party with respect to any matters arising under this Article, including with respect to the notifications and requests referred to in points (a) and (b) of paragraph 3. 5. The envisaged cooperation between the Parties shall involve the customs authorities of the Parties responsible for managing export procedures for cultural property as appropriate and necessary. 6. Title I of Part Six does not apply to this Article. CHAPTER 2 RULES OF ORIGIN SECTION 1 RULES OF ORIGIN Article 37 Objective The objective of this Chapter is to lay down the provisions determining the origin of goods for the purpose of application of preferential tariff treatment under this Agreement, and setting out related origin procedures. Article 38 Definitions For the purposes of this Chapter, the following definitions apply: (a) \"classification\" means the classification of a product or material under a particular chapter, heading, or sub-heading of the Harmonised System; (b) \"consignment\" means products which are either sent simultaneously from one exporter to one consignee or covered by a single transport document covering their shipment from the exporter to the consignee or, in the absence of such a document, by a single invoice; (c) \"exporter\" means a person, located in a Party, who, in accordance with the requirements laid down in the laws and regulations of that Party, exports or produces the originating product and makes out a statement on origin; (d) \"importer\" means a person who imports the originating product and claims preferential tariff treatment for it; (e) \"material\" means any substance used in the production of a product, including any components, ingredients, raw materials, or parts; (f) \"non-originating material\" means a material which does not qualify as originating under this Chapter, including a material whose originating status cannot be determined; (g) \"product\" means the product resulting from the production, even if it is intended for use as a material in the production of another product; (h) \"production\" means any kind of working or processing including assembly. Article 39 General requirements 1. For the purposes of applying the preferential tariff treatment by a Party to the originating good of the other Party in accordance with this Agreement, provided that the products satisfy all other applicable requirements of this Chapter, the following products shall be considered as originating in the other Party: (a) products wholly obtained in that Party within the meaning of Article 41; (b) products produced in that Party exclusively from originating materials in that Party; and (c) products produced in that Party incorporating non-originating materials provided they satisfy the requirements set out in Annex 3. 2. If a product has acquired originating status, the non-originating materials used in the production of that product shall not be considered as non-originating when that product is incorporated as a material in another product. 3. The acquisition of originating status shall be fulfilled without interruption in the United Kingdom or the Union. Article 40 Cumulation of origin 1. A product originating in a Party shall be considered as originating in the other Party if that product is used as a material in the production of another product in that other Party. 2. Production carried out in a Party on a non-originating material may be taken into account for the purpose of determining whether a product is originating in the other Party. 3. Paragraphs 1 and 2 do not apply if the production carried out in the other Party does not go beyond the operations referred to in Article 43. 4. In order for an exporter to complete the statement on origin referred to in point (a) of Article 54(2) for a product referred to in paragraph 2 of this Article, the exporter shall obtain from its supplier a supplier's declaration as provided for in Annex 6 or an equivalent document that contains the same information describing the non-originating materials concerned in sufficient detail to enable them to be identified. Article 41 Wholly obtained products 1. The following products shall be considered as wholly obtained in a Party: (a) mineral products extracted or taken from its soil or from its seabed; (b) plants and vegetable products grown or harvested there; (c) live animals born and raised there; (d) products obtained from live animals raised there; (e) products obtained from slaughtered animals born and raised there; (f) products obtained by hunting or fishing conducted there; (g) products obtained from aquaculture there if aquatic organisms, including fish, molluscs, crustaceans, other aquatic invertebrates and aquatic plants are born or raised from seed stock such as eggs, roes, fry, fingerlings, larvae, parr, smolts or other immature fish at a post-larval stage by intervention in the rearing or growth processes to enhance production such as regular stocking, feeding or protection from predators; (h) products of sea fishing and other products taken from the sea outside any territorial sea by a vessel of a Party; (i) products made aboard of a factory ship of a Party exclusively from products referred to in point (h); (j) products extracted from the seabed or subsoil outside any territorial sea provided that they have rights to exploit or work such seabed or subsoil; (k) waste and scrap resulting from production operations conducted there; (l) waste and scrap derived from used products collected there, provided that those products are fit only for the recovery of raw materials; (m) products produced there exclusively from the products specified in points (a) to (l). 2. The terms \"vessel of a Party\" and \"factory ship of a Party\" in points (h) and (i) of paragraph 1 mean a vessel and factory ship which: (a) is registered in a Member State or in the United Kingdom; (b) sails under the flag of a Member State or of the United Kingdom; and (c) meets one of the following conditions: (i) it is at least 50 % owned by nationals of a Member State or of the United Kingdom; or (ii) it is owned by legal persons which each: (A) have their head office and main place of business in the Union or the United Kingdom; and (B) are at least 50 % owned by public entities, nationals or legal persons of a Member State or the United Kingdom. Article 42 Tolerances 1. If a product does not satisfy the requirements set out in Annex 3 due to the use of a non-originating material in its production, that product shall nevertheless be considered as originating in a Party, provided that: (a) the total weight of non-originating materials used in the production of products classified under Chapters 2 and 4 to 24 of the Harmonised System, other than processed fishery products classified under Chapter 16, does not exceed 15 % of the weight of the product; (b) the total value of non-originating materials for all other products, except for products classified under Chapters 50 to 63 of the Harmonised System, does not exceed 10 % of the ex-works price of the product; or (c) for a product classified under Chapters 50 to 63 of the Harmonised System, the tolerances set out in Notes 7 and 8 of Annex 2 apply. 2. Paragraph 1 does not apply if the value or weight of non-originating materials used in the production of a product exceeds any of the percentages for the maximum value or weight of non-originating materials as specified in the requirements set out in Annex 3. 3. Paragraph 1 of this Article does not apply to products wholly obtained in a Party within the meaning of Article 41. If Annex 3 requires that the materials used in the production of a product are wholly obtained, paragraphs 1 and 2 of this Article apply. Article 43 Insufficient production 1. Notwithstanding point (c) of Article 39(1), a product shall not be considered as originating in a Party if the production of the product in a Party consists only of one or more of the following operations conducted on non-originating materials: (a) preserving operations such as drying, freezing, keeping in brine and other similar operations where their sole purpose is to ensure that the products remain in good condition during transport and storage; (2) (b) breaking-up or assembly of packages; (c) washing, cleaning; removal of dust, oxide, oil, paint or other coverings; (d) ironing or pressing of textiles and textile articles; (e) simple painting and polishing operations; (f) husking and partial or total milling of rice; polishing and glazing of cereals and rice; bleaching of rice; (g) operations to colour or flavour sugar or form sugar lumps; partial or total milling of sugar in solid form; (h) peeling, stoning and shelling, of fruits, nuts and vegetables; (i) sharpening, simple grinding or simple cutting; (j) sifting, screening, sorting, classifying, grading, matching including the making-up of sets of articles; (k) simple placing in bottles, cans, flasks, bags, cases, boxes, fixing on cards or boards and all other simple packaging operations; (l) affixing or printing marks, labels, logos and other like distinguishing signs on products or their packaging; (m) simple mixing of products, whether or not of different kinds; mixing of sugar with any material; (n) simple addition of water or dilution with water or another substance that does not materially alter the characteristics of the product, or dehydration or denaturation of products; (o) simple assembly of parts of articles to constitute a complete article or disassembly of products into parts; (p) slaughter of animals. 2. For the purposes of paragraph 1, operations shall be considered simple if neither special skills nor machines, apparatus or equipment especially produced or installed are needed for carrying out those operations. Article 44 Unit of qualification 1. For the purposes of this Chapter, the unit of qualification shall be the particular product which is considered as the basic unit when classifying the product under the Harmonised System. 2. For a consignment consisting of a number of identical products classified under the same heading of the Harmonised System, each individual product shall be taken into account when applying the provisions of this Chapter. Article 45 Packing materials and containers for shipment Packing materials and containers for shipment that are used to protect a product during transportation shall be disregarded in determining whether a product is originating. Article 46 Packaging materials and containers for retail sale Packaging materials and containers in which the product is packaged for retail sale, if classified with the product, shall be disregarded in determining the origin of the product, except for the purposes of calculating the value of non-originating materials if the product is subject to a maximum value of non-originating materials in accordance with Annex 3. Article 47 Accessories, spare parts and tools 1. Accessories, spare parts, tools and instructional or other information materials shall be regarded as one product with the piece of equipment, machine, apparatus or vehicle in question if they: (a) are classified and delivered with, but not invoiced separately from, the product; and (b) are of the types, quantities and value which are customary for that product. 2. Accessories, spare parts, tools and instructional or other information materials referred to paragraph 1 shall be disregarded in determining the origin of the product except for the purposes of calculating the value of non-originating materials if a product is subject to a maximum value of non-originating materials as set out in Annex 3. Article 48 Sets Sets, as defined in General Rule 3 for the Interpretation of the Harmonised System, shall be considered as originating in a Party if all of their components are originating. If a set is composed of originating and non-originating components, the set as a whole shall be considered as originating in a Party if the value of the non-originating components does not exceed 15 % of the ex-works price of the set. Article 49 Neutral elements In order to determine whether a product is originating in a Party, it shall not be necessary to determine the origin of the following elements, which might be used in its production: (a) fuel, energy, catalysts and solvents; (b) plant, equipment, spare parts and materials used in the maintenance of equipment and buildings; (c) machines, tools, dies and moulds; (d) lubricants, greases, compounding materials and other materials used in production or used to operate equipment and buildings; (e) gloves, glasses, footwear, clothing, safety equipment and supplies; (f) equipment, devices and supplies used for testing or inspecting the product; and (g) other materials used in the production which are not incorporated into the product nor intended to be incorporated into the final composition of the product. Article 50 Accounting segregation 1. Originating and non-originating fungible materials or fungible products shall be physically segregated during storage in order to maintain their originating and non-originating status. 2. For the purpose of paragraph 1, \"fungible materials\" or \"fungible products\" means materials or products that are of the same kind and commercial quality, with the same technical and physical characteristics, and that cannot be distinguished from one another for origin purposes. 3. Notwithstanding paragraph 1, originating and non-originating fungible materials may be used in the production of a product without being physically segregated during storage if an accounting segregation method is used. 4. Notwithstanding paragraph 1, originating and non-originating fungible products classified under Chapters 10, 15, 27, 28, 29, headings 32.01 to 32.07, or headings 39.01 to 39.14 of the Harmonised System may be stored in a Party before exportation to the other Party without being physically segregated, provided that an accounting segregation method is used. 5. The accounting segregation method referred to in paragraphs 3 and 4 shall be applied in conformity with a stock management method under accounting principles which are generally accepted in the Party. 6. The accounting segregation method shall be any method that ensures that at any time no more materials or products receive originating status than would be the case if the materials or products had been physically segregated. 7. A Party may require, under conditions set out in its laws or regulations, that the use of an accounting segregation method is subject to prior authorisation by the customs authorities of that Party. The customs authorities of the Party shall monitor the use of such authorisations and may withdraw an authorisation if the holder makes improper use of the accounting segregation method or fails to fulfil any of the other conditions laid down in this Chapter. Article 51 Returned products If a product originating in a Party exported from that Party to a third country returns to that Party, it shall be considered as a non-originating product unless it can be demonstrated to the satisfaction of the customs authority of that Party that the returning product: (a) is the same as that exported; and (b) has not undergone any operation other than what was necessary to preserve it in good condition while in that third country or while being exported. Article 52 Non-alteration 1. An originating product declared for home use in the importing Party shall not, after exportation and prior to being declared for home use, have been altered, transformed in any way or subjected to operations other than to preserve it in good condition or than adding or affixing marks, labels, seals or any other documentation to ensure compliance with specific domestic requirements of the importing Party. 2. The storage or exhibition of a product may take place in a third country, provided that the product remains under customs supervision in that third country. 3. The splitting of consignments may take place in a third country if it is carried out by the exporter or under the responsibility of the exporter, provided that the consignments remain under customs supervision in that third country. 4. In the case of doubt as to whether the requirements provided for in paragraphs 1 to 3 are complied with, the customs authority of the importing Party may request the importer to provide evidence of compliance with those requirements, which may be given by any means, including contractual transport documents such as bills of lading or factual or concrete evidence based on the marking or numbering of packages or any evidence related to the product itself. Article 53 Review of drawback of, or exemption from, customs duties Not earlier than two years from the entry into force of this Agreement, at the request of either Party, the Trade Specialised Committee on Customs Cooperation and Rules of Origin shall review the Parties' respective duty drawback and inward-processing schemes. For that purpose, at the request of a Party, no later than 60 days from that request, the other Party shall provide the requesting Party with available information and detailed statistics covering the period from the entry into force of this Agreement, or the previous five years if that period is shorter, on the operation of its duty-drawback and inward-processing scheme. In the light of this review, the Trade Specialised Committee on Customs Cooperation and Rules of Origin may make recommendations to the Partnership Council for the amendment of the provisions of this Chapter and its Annexes, with a view to introducing limitations or restrictions with respect to drawback of or exemption from customs duties. SECTION 2 ORIGIN PROCEDURES Article 54 Claim for preferential tariff treatment 1. The importing Party, on importation, shall grant preferential tariff treatment to a product originating in the other Party within the meaning of this Chapter on the basis of a claim by the importer for preferential tariff treatment. The importer shall be responsible for the correctness of the claim for preferential tariff treatment and for compliance with the requirements provided for in this Chapter. 2. A claim for preferential tariff treatment shall be based on: (a) a statement on origin that the product is originating made out by the exporter; or (b) the importer's knowledge that the product is originating. 3. The importer making the claim for preferential tariff treatment based on a statement on origin as referred to in point (a) of paragraph 2 shall keep the statement on origin and, when required by the customs authority of the importing Party, shall provide a copy thereof to that customs authority. Article 55 Time of the claim for preferential tariff treatment 1. A claim for preferential tariff treatment and the basis for that claim as referred to in Article 54(2) shall be included in the customs import declaration in accordance with the laws and regulations of the importing Party. 2. By way of derogation from paragraph 1 of this Article, if the importer did not make a claim for preferential tariff treatment at the time of importation, the importing Party shall grant preferential tariff treatment and repay or remit any excess customs duty paid provided that: (a) the claim for preferential tariff treatment is made no later than three years after the date of importation, or such longer time period as specified in the laws and regulations of the importing Party; (b) the importer provides the basis for the claim as referred to in Article 54(2); and (c) the product would have been considered originating and would have satisfied all other applicable requirements within the meaning of Section 1 of this Chapter if it had been claimed by the importer at the time of importation. The other obligations applicable to the importer under Article 54 remain unchanged. Article 56 Statement on origin 1. A statement on origin shall be made out by an exporter of a product on the basis of information demonstrating that the product is originating, including, information on the originating status of materials used in the production of the product. The exporter shall be responsible for the correctness of the statement on origin and the information provided. 2. A statement on origin shall be made out using one of the language versions set out in Annex 7 in an invoice or on any other document that describes the originating product in sufficient detail to enable the identification of that product. The exporter shall be responsible for providing sufficient detail to allow the identification of the originating product. The importing Party shall not require the importer to submit a translation of the statement on origin. 3. A statement on origin shall be valid for 12 months from the date it was made out or for such longer period as provided by the Party of import up to a maximum of 24 months. 4. A statement on origin may apply to: (a) a single shipment of one or more products imported into a Party; or (b) multiple shipments of identical products imported into a Party within the period specified in the statement on origin, which shall not exceed 12 months. 5. If, at the request of the importer, unassembled or disassembled products within the meaning of General Rule 2(a) for the Interpretation of the Harmonised System that fall within Sections XV to XXI of the Harmonised System are imported by instalments, a single statement on origin for such products may be used in accordance with the requirements laid down by the customs authority of the importing Party. Article 57 Discrepancies The customs authority of the importing Party shall not reject a claim for preferential tariff treatment due to minor errors or discrepancies in the statement on origin, or for the sole reason that an invoice was issued in a third country. Article 58 Importer's knowledge 1. For the purposes of a claim for preferential tariff treatment that is made under point (b) of Article 54(2), the importer's knowledge that a product is originating in the exporting Party shall be based on information demonstrating that the product is originating and satisfies the requirements provided for in this Chapter. 2. Before claiming the preferential treatment, in the event that an importer is unable to obtain the information referred to in paragraph 1 of this Article as a result of the exporter deeming that information to be confidential information or for any other reason, the exporter may provide a statement on origin so that the importer may claim the preferential tariff treatment on the basis of point (a) of Article 54(2). Article 59 Record-keeping requirements 1. For a minimum of three years after the date of importation of the product, an importer making a claim for preferential tariff treatment for a product imported into the importing Party shall keep: (a) if the claim was based on a statement on origin, the statement on origin made out by the exporter; or (b) if the claim was based on the importer's knowledge, all records demonstrating that the product satisfies the requirements for obtaining originating status. 2. An exporter who has made out a statement on origin shall, for a minimum of four years after that statement on origin was made out, keep a copy of the statement on origin and all other records demonstrating that the product satisfies the requirements to obtain originating status. 3. The records to be kept in accordance with this Article may be held in electronic format. Article 60 Small consignments 1. By way of derogation from Articles 54 to 58, provided that the product has been declared as meeting the requirements of this Chapter and the customs authority of the importing Party has no doubts as to the veracity of that declaration, the importing Party shall grant preferential tariff treatment to: (a) a product sent in a small package from private persons to private persons; (b) a product forming part of a traveller's personal luggage; and (c) for the United Kingdom, in addition to points (a) and (b) of this Article, other low value consignments. 2. The following products are excluded from the application of paragraph 1 of this Article: (a) products, the importation of which forms part of a series of importations that may reasonably be considered to have been made separately for the purpose of avoiding the requirements of Article 54; (b) for the Union: (i) a product imported by way of trade; the imports which are occasional and consist solely of products for the personal use of the recipients or travellers or their families are not be considered as imports by way of trade if it is evident from the nature and quantity of the products that no commercial purpose is intended; and (ii) products, the total value of which exceeds EUR 500 in the case of products sent in small packages, or EUR 1 200 in the case of products forming part of a traveller's personal luggage. The amounts to be used in a given national currency shall be the equivalent in that currency of the amounts expressed in euro as at the first working day of October. The exchange rate amounts shall be those published for that day by the European Central Bank, unless a different amount is communicated to the European Commission by 15 October, and shall apply from 1 January the following year. The European Commission shall notify the United Kingdom of the relevant amounts. The Union may establish other limits which it will communicate to the United Kingdom; and (c) for the United Kingdom, products whose total value exceeds the limits set under the domestic law of the United Kingdom. The United Kingdom will communicate these limits to the Union. 3. The importer shall be responsible for the correctness of the declaration and for the compliance with the requirements provided for in this Chapter. The record-keeping requirements set out in Article 59 shall not apply to the importer under this Article. Article 61 Verification 1. The customs authority of the importing Party may conduct a verification as to whether a product is originating or whether the other requirements of this Chapter are satisfied, on the basis of risk assessment methods, which may include random selection. Such verifications may be conducted by means of a request for information from the importer who made the claim referred to in Article 54, at the time the import declaration is submitted, before the release of the products, or after the release of the products. 2. The information requested pursuant to paragraph 1 shall cover no more than the following elements: (a) if the claim was based on a statement on origin, that statement on origin; and (b) information pertaining to the fulfilment of origin criteria, which is: (i) where the origin criterion is \"wholly obtained\", the applicable category (such as harvesting, mining, fishing) and the place of production; (ii) where the origin criterion is based on change in tariff classification, a list of all the non-originating materials, including their tariff classification (in 2, 4 or 6-digit format, depending on the origin criterion); (iii) where the origin criterion is based on a value method, the value of the final product as well as the value of all the non-originating materials used in the production of that product; (iv) where the origin criterion is based on weight, the weight of the final product as well as the weight of the relevant non-originating materials used in the final product; (v) where the origin criterion is based on a specific production process, a description of that specific process. 3. When providing the requested information, the importer may add any other information that it considers relevant for the purpose of verification. 4. If the claim for preferential tariff treatment is based on a statement on origin, the importer shall provide that statement on origin but may reply to the customs authority of the importing Party that the importer is not in a position to provide the information referred to in point (b) of paragraph 2. 5. If the claim for preferential tariff treatment is based on the importer's knowledge, after having first requested information in accordance with paragraph 1, the customs authority of the importing Party conducting the verification may request the importer to provide additional information if that customs authority considers that additional information is necessary in order to verify the originating status of the product or whether the other requirements of this Chapter are met. The customs authority of the importing Party may request the importer for specific documentation and information, if appropriate. 6. If the customs authority of the importing Party decides to suspend the granting of preferential tariff treatment to the product concerned while awaiting the results of the verification, the release of the products shall be offered to the importer subject to appropriate precautionary measures including guarantees. Any suspension of preferential tariff treatment shall be terminated as soon as possible after the customs authority of the importing Party has ascertained the originating status of the products concerned, or the fulfilment of the other requirements of this Chapter. Article 62 Administrative cooperation 1. In order to ensure the proper application of this Chapter, the Parties shall cooperate, through the customs authority of each Party, in verifying whether a product is originating and is in compliance with the other requirements provided for in this Chapter. 2. If the claim for preferential tariff treatment was based on a statement on origin, as appropriate after having first requested information in accordance with Article 61(1) and based on the reply from the importer, the customs authority of the importing Party conducting the verification may also request information from the customs authority of the exporting Party within a period of two years after the importation of the products, or from the moment the claim is made pursuant to point (a) of Article 55(2) if the customs authority of the importing Party conducting the verification considers that additional information is necessary in order to verify the originating status of the product or to verify that the other requirements provided for in this Chapter have been met. The request for information shall include the following elements: (a) the statement on origin; (b) the identity of the customs authority issuing the request; (c) the name of the exporter; (d) the subject and scope of the verification; and (e) any relevant documentation. In addition, the customs authority of the importing Party may request the customs authority of the exporting Party to provide specific documentation and information, where appropriate. 3. The customs authority of the exporting Party may, in accordance with its laws and regulations, request documentation or examination by calling for any evidence, or by visiting the premises of the exporter, to review records and observe the facilities used in the production of the product. 4. Without prejudice to paragraph 5, the customs authority of the exporting Party receiving the request referred to in paragraph 2 shall provide the customs authority of the importing Party with the following information: (a) the requested documentation, where available; (b) an opinion on the originating status of the product; (c) the description of the product that is subject to examination and the tariff classification relevant to the application of this Chapter; (d) a description and explanation of the production process that is sufficient to support the originating status of the product; (e) information on the manner in which the examination of the product was conducted; and (f) supporting documentation, where appropriate. 5. The customs authority of the exporting Party shall not provide the information referred to in points (a), (d) and (f) of paragraph 4 to the customs authority of the importing Party if that information is deemed confidential by the exporter. 6. Each Party shall notify the other Party of the contact details of the customs authorities and shall notify the other Party of any change to those contact details within 30 days after the date of the change. Article 63 Denial of preferential tariff treatment 1. Without prejudice to paragraph 3, the customs authority of the importing Party may deny preferential tariff treatment, if: (a) within three months after the date of a request for information pursuant to Article 61(1): (i) no reply has been provided by the importer; (ii) where the claim for preferential tariff treatment was based on a statement on origin, no statement on origin has been provided; or (iii) where the claim for preferential tariff treatment was based on the importer's knowledge, the information provided by the importer is inadequate to confirm that the product is originating; (b) within three months after the date of a request for additional information pursuant to Article 61(5): (i) no reply has been provided by the importer; or (ii) the information provided by the importer is inadequate to confirm that the product is originating; (c) within 10 months (3) after the date of a request for information pursuant to Article 62(2): (i) no reply has been provided by the customs authority of the exporting Party; or (ii) the information provided by the customs authority of the exporting Party is inadequate to confirm that the product is originating. 2. The customs authority of the importing Party may deny preferential tariff treatment to a product for which an importer claims preferential tariff treatment where the importer fails to comply with requirements under this Chapter other than those relating to the originating status of the products. 3. If the customs authority of the importing Party has sufficient justification to deny preferential tariff treatment under paragraph 1 of this Article, in cases where the customs authority of the exporting Party has provided an opinion pursuant to point (b) of Article 62(4) confirming the originating status of the products, the customs authority of the importing Party shall notify the customs authority of the exporting Party of its intention to deny the preferential tariff treatment within two months after the date of receipt of that opinion. If such notification is made, consultations shall be held at the request of either Party, within three months after the date of the notification. The period for consultation may be extended on a case-by-case basis by mutual agreement between the customs authorities of the Parties. The consultation may take place in accordance with the procedure set by the Trade Specialised Committee on Customs Cooperation and Rules of Origin. Upon the expiry of the period for consultation, if the customs authority of the importing Party cannot confirm that the product is originating, it may deny the preferential tariff treatment if it has a sufficient justification for doing so and after having granted the importer the right to be heard. However, when the customs authority of the exporting Party confirms the originating status of the products and provides justification for such conclusion, the customs authority of the importing Party shall not deny preferential tariff treatment to a product on the sole ground that Article 62(5) has been applied. 4. In all cases, the settlement of differences between the importer and the customs authority of the Party of import shall be under the law of the Party of import. Article 64 Confidentiality 1. Each Party shall maintain, in accordance with its laws and regulations, the confidentiality of any information provided to it by the other Party, pursuant to this Chapter, and shall protect that information from disclosure. 2. Where, notwithstanding Article 62(5), confidential business information has been obtained from the exporter by the customs authority of the exporting Party or importing Party through the application of Articles 61 and 62, that information shall not be disclosed. 3. Each Party shall ensure that confidential information collected pursuant to this Chapter shall not be used for purposes other than the administration and enforcement of decisions and determinations relating to origin and to customs matters, except with the permission of the person or Party who provided the confidential information. 4. Notwithstanding paragraph 3, a Party may allow information collected pursuant to this Chapter to be used in any administrative, judicial, or quasi-judicial proceedings instituted for failure to comply with customs-related laws implementing this Chapter. A Party shall notify the person or Party who provided the information in advance of such use. Article 65 Administrative measures and sanctions Each Party shall ensure the effective enforcement of this Chapter. Each Party shall ensure that the competent authorities are able to impose administrative measures, and, where appropriate, sanctions, in accordance with its laws and regulations, on any person who draws up a document, or causes a document to be drawn up, which contains incorrect information that was provided for the purpose of obtaining a preferential tariff treatment for a product, who does not comply with the requirements set out in Article 59, or who does not provide the evidence, or refuses to submit to a visit, as referred to in Article 62(3). SECTION 3 OTHER PROVISIONS Article 66 Ceuta and Melilla 1. For purposes of this Chapter, in the case of the Union, the term \"Party\" does not include Ceuta and Melilla. 2. Products originating in the United Kingdom, when imported into Ceuta and Melilla, shall in all respects be subject to the same customs treatment under this Agreement as that which is applied to products originating in the customs territory of the Union under Protocol 2 of the Act of Accession of the Kingdom of Spain and the Portuguese Republic to the European Union. The United Kingdom shall grant to imports of products covered by this Agreement and originating in Ceuta and Melilla the same customs treatment as that which is granted to products imported from and originating in the Union. 3. The rules of origin and origin procedures referred to in this Chapter apply mutatis mutandis to products exported from the United Kingdom to Ceuta and Melilla and to products exported from Ceuta and Melilla to the United Kingdom. 4. Ceuta and Melilla shall be considered as a single territory. 5. Article 40 applies to import and exports of products between the Union, the United Kingdom and Ceuta and Melilla. 6. The exporters shall enter \"the United Kingdom\" or \"Ceuta and Melilla\" in field 3 of the text of the statement on origin, depending on the origin of the product. 7. The customs authority of the Kingdom of Spain shall be responsible for the application and implementation of this Chapter in Ceuta and Melilla. Article 67 Transitional provisions for products in transit or storage The provisions of this Agreement may be applied to products which comply with the provisions of this Chapter and which on the date of entry into force of this Agreement are either in transit from the exporting Party to the importing Party or under customs control in the importing Party without payment of import duties and taxes, subject to the making of a claim for preferential tariff treatment referred to in Article 54 to the customs authority of the importing Party, within 12 months of that date. Article 68 Amendment to this Chapter and its Annexes The Partnership Council may amend this Chapter and its Annexes. CHAPTER 3 SANITARY AND PHYTOSANITARY MEASURES Article 69 Objectives The objectives of this Chapter are to: (a) protect human, animal and plant life or health in the territories of the Parties while facilitating trade between the Parties; (b) further the implementation of the SPS Agreement; (c) ensure that the Parties' sanitary and phytosanitary (\"SPS\") measures do not create unnecessary barriers to trade; (d) promote greater transparency and understanding on the application of each Party's SPS measures; (e) enhance cooperation between the Parties in the fight against antimicrobial resistance, promotion of sustainable food systems, protection of animal welfare, and on electronic certification; (f) enhance cooperation in the relevant international organisations to develop international standards, guidelines and recommendations on animal health, food safety and plant health; and (g) promote implementation by each Party of international standards, guidelines and recommendations. Article 70 Scope 1. This Chapter applies to all SPS measures of a Party that may, directly or indirectly, affect trade between the Parties. 2. This Chapter also lays down separate provisions regarding cooperation on animal welfare, antimicrobial resistance and sustainable food systems. Article 71 Definitions 1. For the purposes of this Chapter, the following definitions apply: (a) the definitions contained in Annex A of the SPS Agreement; (b) the definitions adopted under the auspices of the Codex Alimentarius Commission (the \"Codex\"); (c) the definitions adopted under the auspices of the World Organisation for Animal Health (the \"OIE\"); and (d) the definitions adopted under the auspices of the International Plant Protection Convention (the \"IPPC\"). 2. For the purposes of this Chapter, the following definitions apply: (a) \"import conditions\" means any SPS measures that are required to be fulfilled for the import of products; and (b) \"protected zone\" for a specified regulated plant pest means an officially defined geographical area in which that pest is not established in spite of favourable conditions and its presence in other parts of the territory of the Party, and into which that pest is not allowed to be introduced. 3. The Trade Specialised Committee on Sanitary and Phytosanitary Measures may adopt other definitions for the purposes of this Chapter, taking into consideration the glossaries and definitions of the relevant international organisations, such as the Codex, OIE and IPPC. 4. The definitions under the SPS Agreement prevail to the extent that there is an inconsistency between the definitions adopted by the Trade Specialised Committee on Sanitary and Phytosanitary Measures or adopted under the auspices of the Codex, the OIE, the IPPC and the definitions under the SPS Agreement. In the event of an inconsistency between definitions adopted by the Trade Specialised Committee on Sanitary and Phytosanitary Measures and the definitions set out in the Codex, OIE or IPPC, the definitions set out in the Codex, OIE or IPPC shall prevail. Article 72 Rights and obligations The Parties reaffirm their rights and obligations under the SPS Agreement. This includes the right to adopt measures in accordance with Article 5(7) of the SPS Agreement. Article 73 General principles 1. The Parties shall apply SPS measures for achieving their appropriate level of protection that are based on risk assessments in accordance with relevant provisions, including Article 5 of the SPS Agreement. 2. The Parties shall not use SPS measures to create unjustified barriers to trade. 3. Regarding trade-related SPS procedures and approvals established under this Chapter, each Party shall ensure that those procedures and related SPS measures: (a) are initiated and completed without undue delay; (b) do not include unnecessary, scientifically and technically unjustified or unduly burdensome information requests that might delay access to each other's markets; (c) are not applied in a manner which would constitute arbitrary or unjustifiable discrimination against the other Party's entire territory or parts of the other Party's territory where identical or similar SPS conditions exist; and (d) are proportionate to the risks identified and not more trade restrictive than necessary to achieve the importing Party's appropriate level of protection. 4. The Parties shall not use the procedures referred to in paragraph 3, or any requests for additional information, to delay access to their markets without scientific and technical justification. 5. Each Party shall ensure that any administrative procedure it requires concerning the import conditions on food safety, animal health or plant health is not more burdensome or trade restrictive than necessary to give the importing Party adequate confidence that these conditions are met. Each Party shall ensure that the negative effects on trade of any administrative procedures are kept to a minimum and that the clearance processes remain simple and expeditious while meeting the importing Party's conditions. 6. The importing Party shall not put in place any additional administrative system or procedure that unnecessarily hampers trade. Article 74 Official certification 1. Where the importing Party requires official certificates, the model certificates shall be: (a) set in line with the principles as laid down in the international standards of the Codex, the IPPC and the OIE; and (b) applicable to imports from all parts of the territory of the exporting Party. 2. The Trade Specialised Committee on Sanitary and Phytosanitary Measures may agree on specific cases where the model certificates referred to in paragraph 1 would be established only for a part or parts of the territory of the exporting Party. The Parties shall promote the implementation of electronic certification and other technologies to facilitate trade. Article 75 Import conditions and procedures 1. Without prejudice to the rights and obligations each Party has under the SPS Agreement and this Chapter, the import conditions of the importing Party shall apply to the entire territory of the exporting Party in a consistent manner. 2. The exporting Party shall ensure that products exported to the other Party, such as animals and animal products, plants and plant products, or other related objects, meet the SPS requirements of the importing Party. 3. The importing Party may require that imports of particular products are subject to authorisation. Such authorisation shall be granted where a request is made by the relevant competent authority of the exporting Party which objectively demonstrates, to the satisfaction of the importing Party, that the authorisation requirements of the importing Party are fulfilled. The relevant competent authority of the exporting Party may make a request for authorisation in respect of the entire territory of the exporting Party. The importing Party shall grant such requests on that basis, where they fulfil the authorisation requirements of the importing Party as set out in this paragraph. 4. The importing Party shall not introduce authorisation requirements which are additional to those which apply at the end of the transition period, unless the application of such requirements to further products is justified to mitigate a significant risk to human, animal or plant health. 5. The importing Party shall establish and communicate to the other Party import conditions for all products. The importing Party shall ensure that its import conditions are applied in a proportionate and non-discriminatory manner. 6. Without prejudice to provisional measures under Article 5(7) of the SPS Agreement, for products, or other related objects, where a phytosanitary concern exists, the import conditions shall be restricted to measures to protect against regulated pests of the importing Party and shall be applicable to the entire territory of the exporting Party. 7. Notwithstanding paragraphs 1 and 3, in the case of import authorisation requests for a specific product, where the exporting Party has requested to be examined only for a part, or certain parts, of its territory (in the case of the Union, individual Member States), the importing Party shall promptly proceed to the examination of that request. Where the importing Party receives requests in respect of the specific product from more than one part of the exporting Party, or, where further requests are received in respect of a product which has already been authorised, the importing Party shall expedite completion of the authorisation procedure, taking into account the identical or similar SPS regime applicable in the different parts of the exporting Party. 8. Each Party shall ensure that all SPS control, inspection and approval procedures are initiated and completed without undue delay. Information requirements shall be limited to what is necessary for the approval process to take into account information already available in the importing Party, such as on the legislative framework and audit reports of the exporting Party. 9. Except in duly justified circumstances related to its level of protection, each Party shall provide a transition period between the publication of any changes to its approval procedures and their application to allow the other Party to become familiar with and adapt to such changes. Each Party shall not unduly prolong the approval process for applications submitted prior to publication of the changes. 10. In relation to the processes set out in paragraphs 3 to 8, the following actions shall be taken: (a) as soon as the importing Party has positively concluded its assessment, it shall promptly take all necessary legislative and administrative measures to allow trade to take place without undue delay; (b) the exporting Party shall: (i) provide all relevant information required by the importing Party; and (ii) give reasonable access to the importing Party for audit and other relevant procedures. (c) the importing party shall establish a list of regulated pests for products, or other related objects, where a phytosanitary concern exists. That list shall contain: (i) the pests not known to occur within any part of its own territory; (ii) the pests known to occur within its own territory and under official control; (iii) the pests known to occur within parts of its own territory and for which pest free areas or protected zones are established; and (iv) non-quarantine pests known to occur within its own territory and under official control for specified planting material. 11. The importing Party shall accept consignments without requiring that the importing Party verifies compliance of those consignments before their departure from the territory of the exporting Party. 12. A Party may collect fees for the costs incurred to conduct specific SPS frontier checks, which should not exceed the recovery of the costs. 13. The importing Party shall have the right to carry out import checks on products imported from the exporting Party for the purposes of ensuring compliance with its SPS import requirements. 14. The import checks carried out on products imported from the exporting Party shall be based on the SPS risk associated with such importations. Import checks shall be carried out only to the extent necessary to protect human, animal or plant life and health, without undue delay and with a minimum effect on trade between the Parties. 15. Information on the proportion of products from the exporting Party checked at import shall be made available by the importing Party upon request of the exporting Party. 16. If import checks reveal non-compliance with the relevant import conditions the action taken by the importing Party must be based on an assessment of the risk involved and not be more trade restrictive than required to achieve the Party's appropriate level of SPS protection. Article 76 Lists of approved establishments 1. Whenever justified, the importing Party may maintain a list of approved establishments meeting its import requirements as a condition to allow imports of animal products from these establishments. 2. Unless justified to mitigate a significant risk to human or animal health, lists of approved establishments shall only be required for the products for which they were required at the end of the transition period. 3. The exporting Party shall inform the importing Party of its list of establishments meeting the importing Party's conditions which shall be based on guarantees provided by the exporting Party. 4. Upon a request from the exporting Party, the importing Party shall approve establishments which are situated in the territory of the exporting Party, based on guarantees provided by the exporting Party, without prior inspection of individual establishments. 5. Unless the importing Party requests additional information and subject to guarantees being provided by the exporting party, the importing Party shall take the necessary legislative or administrative measures, in accordance with its applicable legal procedures, to allow imports from those establishments without undue delay. 6. The list of the approved establishments shall be made publicly available by the importing Party. 7. Where the importing Party decides to reject the request of the exporting Party to accept adding an establishment to the list of approved establishments, it shall inform the exporting Party without delay and shall submit a reply, including information about the non-conformities which led to the rejection of the establishment's approval. Article 77 Transparency and exchange of information 1. Each Party shall pursue transparency as regards SPS measures applicable to trade and shall for those purposes undertake the following actions: (a) promptly communicate to the other Party any changes to its SPS measures and approval procedures, including changes that may affect its capacity to fulfil the SPS import requirements of the other Party for certain products; (b) enhance mutual understanding of its SPS measures and their application; (c) exchange information with the other Party on matters related to the development and application of SPS measures, including the progress on new available scientific evidence, that affect, or may affect, trade between the Parties with a view to minimising negative trade effects; (d) upon request of the other Party, communicate the conditions that apply for the import of specific products within 20 working days; (e) upon request of the other Party, communicate the state of play of the procedure for the authorisation of specific products within 20 working days; (f) communicate to the other Party any significant change to the structure or organisation of a Party's competent authority; (g) on request, communicate the results of a Party's official control and a report that concerns the results of the control carried out; (h) on request, communicate the results of an import check provided for in case of a rejected or a non-compliant consignment; and (i) on request, communicate, without undue delay, a risk assessment or scientific opinion produced by a Party that is relevant to this Chapter. 2. Where a Party has made available the information in paragraph 1 via notification to the WTO's Central Registry of Notifications or to the relevant international standard-setting body, in accordance with its relevant rules, the requirements in paragraph 1, as they apply to that information, are fulfilled. Article 78 Adaptation to regional conditions 1. The Parties shall recognise the concept of zoning including disease or pest-free areas, protected zones and areas of low disease or pest prevalence and shall apply it to the trade between the Parties, in accordance with the SPS Agreement, including the guidelines to further the practical implementation of Article 6 of the SPS Agreement (WTO/SPS Committee Decision G/SPS/48) and the relevant recommendations, standards and guidelines of the OIE and IPPC. The Trade Specialised Committee on Sanitary and Phytosanitary Measures may define further details for these procedures, taking into account any relevant SPS Agreement, OIE and IPPC standards, guidelines or recommendations. 2. The Parties may also agree to cooperate on the concept of compartmentalisation as referred to in Chapters 4.4 and 4.5 of the OIE Terrestrial Animal Health Code and Chapters 4.1 and 4.2 of the OIE Aquatic Animal Health Code. 3. When establishing or maintaining the zones referred to in paragraph 1, the Parties shall consider factors such as geographical location, ecosystems, epidemiological surveillance and the effectiveness of SPS controls. 4. With regard to animals and animal products, when establishing or maintaining import conditions upon the request of the exporting Party, the importing Party shall recognise the disease-free areas established by the exporting Party as a basis for consideration towards the determination of allowing or maintaining the import, without prejudice to paragraphs 8 and 9. 5. The exporting Party shall identify the parts of its territory referred to in paragraph 4 and, if requested, provide a full explanation and supporting data based on the OIE standards, or in other ways established by the Trade Specialised Committee on Sanitary and Phytosanitary Measures, based on the knowledge acquired through experience of the exporting Party's relevant authorities. 6. With regard to plants, plant products, and other related objects, when establishing or maintaining phytosanitary import conditions on request of the exporting Party, the importing Party shall recognise the pest-free areas, pest-free places of production, pest-free production sites, areas of low pest prevalence and protected zones established by the exporting Party as a basis for consideration towards the determination to allow or maintain the import, without prejudice to paragraphs 8 and 9. 7. The exporting Party shall identify its pest-free areas, pest-free places of production, pest-free production sites and areas of low pest prevalence or protected zones. If requested by the importing Party, the exporting Party shall provide a full explanation and supporting data based on the International Standards for Phytosanitary Measures developed under the IPPC, or in other ways established by the Trade Specialised Committee on Sanitary and Phytosanitary Measures, based on the knowledge acquired through experience of the exporting Party's relevant phytosanitary authorities. 8. The Parties shall recognise disease-free areas and protected zones which are in place at the end of the transition period. 9. Paragraph 8 shall also apply to subsequent adaptations to the disease-free areas and protected zones (in the case of the United Kingdom pest-free areas), except in cases of significant changes in the disease or pest situations. 10. The Parties may carry out audits and verifications pursuant to Article 79 to implement paragraphs 4 to 9 of this Article. 11. The Parties shall establish close cooperation with the objective of maintaining confidence in the procedures in relation to the establishment of disease- or pest-free areas, pest-free places of production, pest-free production sites and areas of low pest or disease prevalence and protected zones, with the aim to minimise trade disruption. 12. The importing Party shall base its own determination of the animal or plant health status of the exporting Party or parts thereof on the information provided by the exporting Party in accordance with the SPS Agreement, OIE and IPPC standards, and take into consideration any determination made by the exporting Party. 13. Where the importing Party does not accept the determination made by the exporting Party as referred to in paragraph 12 of this Article, the importing Party shall objectively justify and explain to the exporting Party the reasons for that rejection and, upon request, hold consultations, in accordance with Article 80(2). 14. Each Party shall ensure that the obligations set out in paragraphs 4 to 9, 12 and 13 are carried out without undue delay. The importing Party will expedite the recognition of the disease or pest status when the status has been recovered after an outbreak. 15. Where a Party considers that a specific region has a special status with respect to a specific disease and which fulfils the criteria laid down in the OIE Terrestrial Animal Health Code Chapter 1.2 or the OIE Aquatic Animal Health Code Chapter 1.2, it may request recognition of this status. The importing Party may request additional guarantees in respect of imports of live animals and animal products appropriate to the agreed status. Article 79 Audits and verifications 1. The importing Party may carry out audits and verifications of the following: (a) all or part of the other Party's authorities' inspection and certification system; (b) the results of the controls carried out under the exporting Party's inspection and certification system. 2. The Parties shall carry out those audits and verifications in accordance with the provisions of the SPS Agreement, taking into account the relevant international standards, guidelines and recommendations of the Codex, OIE or IPPC. 3. For the purposes of carrying out such audits and verifications, the importing Party may conduct audits and verifications by means of requests of information from the exporting Party or audit and verification visits to the exporting Party, which may include: (a) an assessment of all or part of the responsible authorities' total control programme, including, where appropriate, reviews of regulatory audit and inspection activities; (b) on-the-spot checks; and (c) the collection of information and data to assess the causes of recurring or emerging problems in relation to exports of products. 4. The importing Party shall share with the exporting Party the results and conclusions of the audits and verifications carried out pursuant to paragraph 1. The importing Party may make these results publicly available. 5. Prior to the commencement of an audit or verification, the Parties shall discuss the objectives and scope of the audit or verification, the criteria or requirements against which the exporting Party will be assessed, and the itinerary and procedures for conducting the audit or verification which shall be laid down in an audit or verification plan. Unless otherwise agreed by the Parties, the importing Party shall provide the exporting Party with an audit or verification plan at least 30 days prior to the commencement of the audit or verification. 6. The importing Party shall provide the exporting Party the opportunity to comment on the draft audit or verification report. The importing Party shall provide a final report in writing to the exporting Party normally within two months from the date of receipt of those comments. 7. Each Party shall bear its own costs associated with such an audit or verification. Article 80 Notification and consultation 1. A Party shall notify the other Party without undue delay of: (a) a significant change to pest or disease status; (b) the emergence of a new animal disease; (c) a finding of epidemiological importance with respect to an animal disease; (d) a significant food safety issue identified by a Party; (e) any additional measures beyond the basic requirements of their respective SPS measures taken to control or eradicate animal disease or protect human health, and any changes in preventive policies, including vaccination policies; (f) on request, the results of a Party's official control and a report that concerns the results of the control carried out; and (g) any significant changes to the functions of a system or database. 2. If a Party has a significant concern with respect to food safety, plant health, or animal health, or an SPS measure that the other Party has proposed or implemented, that Party may request technical consultations with the other Party. The requested Party should respond to the request without undue delay. Each Party shall endeavour to provide the information necessary to avoid a disruption to trade and, as the case may be, to reach a mutually acceptable solution. 3. Consultations referred to in paragraph 2 may be held via telephone conference, videoconference, or any other means of communication mutually agreed on by the Parties. Article 81 Emergency measures 1. If the importing Party considers that there is a serious risk to human, animal or plant life and health, it may take without prior notification the necessary measures for the protection of human, animal or plant life and health. For consignments that are in transit between the Parties, the importing Party shall consider the most suitable and proportionate solution to avoid unnecessary disruptions to trade. 2. The Party taking the measures shall notify the other Party of an emergency SPS measure as soon as possible after its decision to implement the measure and no later than 24 hours after the decision has been taken. If a Party requests technical consultations to address the emergency SPS measure, the technical consultations must be held within 10 days of the notification of the emergency SPS measure. The Parties shall consider any information provided through the technical consultations. These consultations shall be carried out in order to avoid unnecessary disruptions to trade. The Parties may consider options for the facilitation of the implementation or the replacement of the measures. 3. The importing Party shall consider, in a timely manner, information that was provided by the exporting Party when it makes its decision with respect to consignments that, at the time of adoption of the emergency SPS measure, are being transported between the Parties, in order to avoid unnecessary disruptions to trade. 4. The importing Party shall ensure that any emergency measure taken on the grounds referred to in paragraph 1 of this Article is not maintained without scientific evidence or, in cases where scientific evidence is insufficient, is adopted in accordance with Article 5(7) of the SPS Agreement. Article 82 Multilateral international fora The Parties agree to cooperate in multilateral international fora on the development of international standards, guidelines and recommendations in the areas under the scope of this Chapter. Article 83 Implementation and competent authorities 1. For the purposes of the implementation of this Chapter, each Party shall take all of the following into account: (a) decisions of the WTO SPS Committee; (b) the work of the relevant international standard setting bodies; (c) any knowledge and past experience it has of trading with the exporting Party; and (d) information provided by the other Party. 2. The Parties shall, without delay, provide each other with a description of the competent authorities of the Parties for the implementation of this Chapter. The Parties shall notify each other of any significant change to these competent authorities. 3. Each Party shall ensure that its competent authorities have the necessary resources to effectively implement this Chapter. Article 84 Cooperation on animal welfare 1. The Parties recognise that animals are sentient beings. They also recognise the connection between improved welfare of animals and sustainable food production systems. 2. The Parties undertake to cooperate in international fora to promote the development of the best possible animal welfare practices and their implementation. In particular, the Parties shall cooperate to reinforce and broaden the scope of the OIE animal welfare standards, as well as their implementation, with a focus on farmed animals. 3. The Parties shall exchange information, expertise and experiences in the field of animal welfare, particularly related to breeding, holding, handling, transportation and slaughter of food-producing animals. 4. The Parties shall strengthen their cooperation on research in the area of animal welfare in relation to animal breeding and the treatment of animals on farms, during transport and at slaughter. Article 85 Cooperation on antimicrobial resistance 1. The Parties shall provide a framework for dialogue and cooperation with a view to strengthening the fight against the development of antimicrobial resistance. 2. The Parties recognise that antimicrobial resistance is a serious threat to human and animal health. Misuse of antimicrobials in animal production, including non-therapeutic use, can contribute to antimicrobial resistance that may represent a risk to human life. The Parties recognise that the nature of the threat requires a transnational and One Health approach. 3. With a view to combating antimicrobial resistance, the Parties shall endeavour to cooperate internationally with regional or multilateral work programmes to reduce the unnecessary use of antibiotics in animal production and to work towards the cessation of the use of antibiotics as growth promotors internationally to combat antimicrobial resistance in line with the One Health approach, and in compliance with the Global Action Plan. 4. The Parties shall collaborate in the development of international guidelines, standards, recommendations and actions in relevant international organisations aiming to promote the prudent and responsible use of antibiotics in animal husbandry and veterinary practices. 5. The dialogue referred to in paragraph 1 shall cover, inter alia: (a) collaboration to follow up existing and future guidelines, standards, recommendations and actions developed in relevant international organisations and existing and future initiatives and national plans aiming to promote the prudent and responsible use of antibiotics and relating to animal production and veterinary practices; (b) collaboration in the implementation of the recommendations of OIE, WHO and Codex, in particular CAC-RCP61/2005; (c) the exchange of information on good farming practices; (d) the promotion of research, innovation and development; (e) the promotion of multidisciplinary approaches to combat antimicrobial resistance, including the One Health approach of the WHO, OIE and Codex. Article 86 Sustainable food systems Each Party shall encourage its food safety, animal and plant health services to cooperate with their counterparts in the other Party with the aim of promoting sustainable food production methods and food systems. Article 87 Trade Specialised Committee on Sanitary and Phytosanitary Measures The Trade Specialised Committee on Sanitary and Phytosanitary Measures shall supervise the implementation and operation of this Chapter and have the following functions: (a) promptly clarifying and addressing, where possible, any issue raised by a Party relating to the development, adoption or application of sanitary and phytosanitary requirements, standards and recommendations under this Chapter or the SPS Agreement; (b) discussing ongoing processes on the development of new regulations; (c) discussing as expeditiously as possible concerns expressed by a Party with regard to the SPS import conditions and procedures applied by the other Party; (d) regularly reviewing the Parties' SPS measures, including certification requirements and border clearance processes, and their application, in order to facilitate trade between the Parties, in accordance with the principles, objectives and procedures set out in Article 5 of the SPS Agreement. Each Party shall identify any appropriate action it will take, including in relation to the frequency of identity and physical checks, taking into consideration the results of this review and based on the criteria laid down in Annex 10 of this Agreement; (e) exchanging views, information, and experiences with respect to the cooperation activities on protecting animal welfare and the fight against antimicrobial resistance carried out under Articles 84 and 85; (f) on request of a Party, considering what constitutes a significant change in the disease or pest situation referred to in Article 78(9); (g) adopting decisions to: (i) add definitions as referred to in Article 71; (ii) define the specific cases referred to in Article 74(2); (iii) define details for the procedures referred to in Article 78(1); (iv) establish other ways to support the explanations referred to in Article 78(5) and (7). CHAPTER 4 TECHNICAL BARRIERS TO TRADE Article 88 Objective The objective of this Chapter is to facilitate trade in goods between the Parties by preventing, identifying and eliminating unnecessary technical barriers to trade. Article 89 Scope 1. This Chapter applies to the preparation, adoption and application of all standards, technical regulations and conformity assessment procedures, which may affect trade in goods between the Parties. 2. This Chapter does not apply to: (a) purchasing specifications prepared by governmental bodies for production or consumption requirements of such bodies; or (b) SPS measures that fall within the scope of Chapter 3 of this Title. 3. The Annexes to this Chapter apply in addition to this Chapter in respect of products within the scope of those Annexes. Any provision in an Annex to this Chapter that an international standard or body or organisation is to be considered or recognised as relevant shall not prevent a standard developed by any other body or organisation from being considered to be a relevant international standard pursuant to Article 91(4) and (5). Article 90 Relationship with the TBT Agreement 1. Articles 2 to 9 of and Annexes 1 and 3 to the TBT Agreement are incorporated into and made part of this Agreement mutatis mutandis. 2. Terms referred to in this Chapter and in the Annexes to this Chapter shall have the same meaning as they have in the TBT Agreement. Article 91 Technical regulations 1. Each Party shall carry out impact assessments of planned technical regulations in accordance with its respective rules and procedures. The rules and procedures referred to in this paragraph and in paragraph 8 may provide for exceptions. 2. Each Party shall assess the available regulatory and non-regulatory alternatives to the proposed technical regulation that may fulfil the Party's legitimate objectives, in accordance with Article 2.2 of the TBT Agreement. 3. Each Party shall use relevant international standards as a basis for its technical regulations except when it can demonstrate that such international standards would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued. 4. International standards developed by the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the International Telecommunication Union (ITU) and the Codex Alimentarius Commission (Codex) shall be the relevant international standards within the meaning of Article 2, Article 5 and Annex 3 of the TBT Agreement. 5. A standard developed by other international organisations may also be considered a relevant international standard within the meaning of Article 2, Article 5 and Annex 3 of the TBT Agreement, provided that: (a) it has been developed by a standardising body which seeks to establish consensus either: (i) among national delegations of the participating WTO Members representing all the national standardising bodies in their territory that have adopted, or expect to adopt, standards on the subject matter to which the international standardisation activity relates, or, (ii) among governmental bodies of participating WTO Members; and (b) it has been developed in accordance with the Decision of the WTO Committee on Technical Barriers to Trade on Principles for the Development of International Standards, Guides and Recommendations with relation to Articles 2, 5, and Annex 3 of the TBT Agreement. (4) 6. Where a Party does not use international standards as a basis for a technical regulation, on request of the other Party, it shall identify any substantial deviation from the relevant international standard, explain the reasons why such standards were judged inappropriate or ineffective for the objective pursued, and provide the scientific or technical evidence on which that assessment was based. 7. Each Party shall review its technical regulations to increase the convergence of those technical regulations with relevant international standards, taking into account, inter alia, any new developments in the relevant international standards or any changes in the circumstances that have given rise to divergence from any relevant international standards. 8. In accordance with its respective rules and procedures and without prejudice to Title X of this Heading, when developing a major technical regulation which may have a significant effect on trade, each Party shall ensure that procedures exist that allow persons to express their opinion in a public consultation, except where urgent problems of safety, health, environment or national security arise or threaten to arise. Each Party shall allow persons of the other Party to participate in such consultations on terms that are no less favourable than those accorded to its own nationals, and shall make the results of those consultations public. Article 92 Standards 1. Each Party shall encourage the standardising bodies established within its territory, as well as the regional standardising bodies of which a Party or the standardising bodies established in its territory are members: (a) to participate, within the limits of their resources, in the preparation of international standards by relevant international standardising bodies; (b) to use relevant international standards as a basis for the standards they develop, except where such international standards would be ineffective or inappropriate, for example because of an insufficient level of protection, fundamental climatic or geographical factors or fundamental technological problems; (c) to avoid duplications of, or overlaps with, the work of international standardising bodies; (d) to review national and regional standards that are not based on relevant international standards at regular intervals, with a view to increasing the convergence of those standards with relevant international standards; (e) to cooperate with the relevant standardising bodies of the other Party in international standardisation activities, including through cooperation in the international standardising bodies or at regional level; (f) to foster bilateral cooperation with the standardising bodies of the other Party; and (g) to exchange information between standardising bodies. 2. The Parties shall exchange information on: (a) their respective use of standards in support of technical regulations; and (b) their respective standardisation processes, and the extent to which they use international, regional or sub-regional standards as a basis for their national standards. 3. Where standards are rendered mandatory in a draft technical regulation or conformity assessment procedure, through incorporation or reference, the transparency obligations set out in Article 94 and in Article 2 or 5 of the TBT Agreement shall apply. Article 93 Conformity assessment 1. Article 91 concerning the preparation, adoption and application of technical regulations shall also apply to conformity assessment procedures, mutatis mutandis. 2. Where a Party requires conformity assessment as a positive assurance that a product conforms with a technical regulation, it shall: (a) select conformity assessment procedures that are proportionate to the risks involved, as determined on the basis of a risk-assessment; (b) consider as proof of compliance with technical regulations the use of a supplier's declaration of conformity, i.e. a declaration of conformity issued by the manufacturer on the sole responsibility of the manufacturer without a mandatory third-party assessment, as assurance of conformity among the options for showing compliance with technical regulations; (c) where requested by the other Party, provide information on the criteria used to select the conformity assessment procedures for specific products. 3. Where a Party requires third party conformity assessment as a positive assurance that a product conforms with a technical regulation and it has not reserved this task to a government authority as specified in paragraph 4, it shall: (a) use accreditation, as appropriate, as a means to demonstrate technical competence to qualify conformity assessment bodies. Without prejudice to its right to establish requirements for conformity assessment bodies, each Party recognises the valuable role that accreditation operated with authority derived from government and on a non-commercial basis can play in the qualification of conformity assessment bodies; (b) use relevant international standards for accreditation and conformity assessment; (c) encourage accreditation bodies and conformity assessment bodies located within its territory to join any relevant functioning international agreements or arrangements for harmonisation or facilitation of acceptance of conformity assessment results; (d) if two or more conformity assessment bodies are authorised by a Party to carry out conformity assessment procedures required for placing a product on the market, ensure that economic operators have a choice amongst the conformity assessment bodies designated by the authorities of a Party for a particular product or set of products; (e) ensure that conformity assessment bodies are independent of manufacturers, importers and economic operators in general and that there are no conflicts of interest between accreditation bodies and conformity assessment bodies; (f) allow conformity assessment bodies to use subcontractors to perform testing or inspections in relation to the conformity assessment, including subcontractors located in the territory of the other Party, and may require subcontractors to meet the same requirements the conformity assessment body must meet to perform such testing or inspections itself; and (g) publish on a single website a list of the bodies that it has designated to perform such conformity assessment and the relevant information on the scope of designation of each such body. 4. Nothing in this Article shall preclude a Party from requiring that conformity assessment in relation to specific products is performed by its specified government authorities. If a Party requires that conformity assessment is performed by its specified government authorities, that Party shall: (a) limit the conformity assessment fees to the approximate cost of the services rendered and, at the request of an applicant for conformity assessment, explain how any fees it imposes for that conformity assessment are limited to the approximate cost of services rendered; and (b) make publicly available the conformity assessment fees. 5. Notwithstanding paragraphs 2 to 4, each Party shall accept a supplier's declaration of conformity as proof of compliance with its technical regulations in those product areas where it does so on the date of entry into force of this Agreement. 6. Each Party shall publish and maintain a list of the product areas referred to in paragraph 5 for information purposes, together with the references to the applicable technical regulations. 7. Notwithstanding paragraph 5, either Party may introduce requirements for the mandatory third party testing or certification of the product areas referred to in that paragraph, provided that such requirements are justified on grounds of legitimate objectives and are proportionate to the purpose of giving the importing Party adequate confidence that products conform with the applicable technical regulations or standards, taking account of the risks that non-conformity would create. 8. A Party proposing to introduce the conformity assessment procedures referred to in paragraph 7 shall notify the other Party at an early stage and shall take the comments of the other Party into account in devising any such conformity assessment procedures. Article 94 Transparency 1. Except where urgent problems of safety, health, environmental protection or national security arise or threaten to arise, each Party shall allow the other Party to provide written comments on notified proposed technical regulations and conformity assessment procedures within a period of at least 60 days from the date of the transmission of the notification of such regulations or procedures to the WTO Central Registry of Notifications. A Party shall give positive consideration to a reasonable request to extend that comment period. 2. Each Party shall provide the electronic version of the full notified text together with the notification. In the event that the notified text is not in one of the official WTO languages, the notifying Party shall provide a detailed and comprehensive description of the content of the measure in the WTO notification format. 3. If a Party receives written comments on its proposed technical regulation or conformity assessment procedure from the other Party, it shall: (a) if requested by the other Party, discuss the written comments with the participation of its competent regulatory authority, at a time when they can be taken into account; and (b) reply in writing to the comments no later than the date of publication of the technical regulation or conformity assessment procedure. 4. Each Party shall endeavour to publish on a website its responses to the comments it receives following the notification referred to in paragraph 1 no later than on the date of publication of the adopted technical regulation or conformity assessment procedure. 5. Each Party shall, where requested by the other Party, provide information regarding the objectives of, legal basis for and rationale for, any technical regulation or conformity assessment procedure that the Party has adopted or is proposing to adopt. 6. Each Party shall ensure that the technical regulations and conformity assessment procedures it has adopted are published on a website that is accessible free of charge. 7. Each Party shall provide information on the adoption and the entry into force of technical regulations or conformity assessment procedures and the adopted final texts through an addendum to the original notification to the WTO. 8. Each Party shall allow a reasonable interval between the publication of technical regulations and their entry into force, in order to allow time for the economic operators of the other Party to adapt. \"Reasonable interval\" means a period of at least six months, unless this would be ineffective in fulfilling the legitimate objectives pursued. 9. A Party shall give positive consideration to a reasonable request from the other Party received prior to the end of the comment period set out in paragraph 1 to extend the period of time between the adoption of the technical regulation and its entry into force, except where the delay would be ineffective in fulfilling the legitimate objectives pursued. 10. Each Party shall ensure that the enquiry point established in accordance with Article 10 of the TBT Agreement provides information and answers in one of the official WTO languages to reasonable enquiries from the other Party or from interested persons of the other Party regarding adopted technical regulations and conformity assessment procedures. Article 95 Marking and labelling 1. The technical regulations of a Party may include or exclusively address mandatory marking or labelling requirements. In such cases, the principles of Article 2.2 of the TBT Agreement apply to these technical regulations. 2. Where a Party requires mandatory marking or labelling of products, all of the following conditions shall apply: (a) it shall only require information which is relevant for consumers or users of the product or information that indicates that the product conforms to the mandatory technical requirements; (b) it shall not require any prior approval, registration or certification of the labels or markings of products, nor any fee disbursement, as a precondition for placing on its market products that otherwise comply with its mandatory technical requirements unless it is necessary in view of legitimate objectives; (c) where the Party requires the use of a unique identification number by economic operators, it shall issue such a number to the economic operators of the other Party without undue delay and on a non-discriminatory basis; (d) unless the information listed in point (i), (ii) or (iii) would be misleading, contradictory or confusing in relation to the information that the importing Party requires with respect to the goods, the importing Party shall permit: (i) information in other languages in addition to the language required in the importing Party of the goods; (ii) internationally-accepted nomenclatures, pictograms, symbols or graphics; and (iii) additional information to that required in the importing Party of the goods; (e) it shall accept that labelling, including supplementary labelling or corrections to labelling, take place in customs warehouses or other designated areas in the country of import as an alternative to labelling in the country of origin, unless such labelling is required to be carried out by approved persons for reasons of public health or safety; and (f) unless it considers that legitimate objectives may be undermined, it shall endeavour to accept the use of non-permanent or detachable labels, or marking or labelling in the accompanying documentation, rather than requiring labels or marking to be physically attached to the product. Article 96 Cooperation on market surveillance and non-food product safety and compliance 1. The Parties recognise the importance of cooperation on market surveillance, compliance and the safety of non-food products for the facilitation of trade and for the protection of consumers and other users, and the importance of building mutual trust based on shared information. 2. To guarantee the independent and impartial functioning of market surveillance, the Parties shall ensure: (a) the separation of market surveillance functions from conformity assessment functions; and (b) the absence of any interests that would affect the impartiality of market surveillance authorities in the performance of their control or supervision of economic operators. 3. The Parties shall cooperate and exchange information in the area of non-food product safety and compliance, which may include in particular the following: (a) market surveillance and enforcement activities and measures; (b) risk assessment methods and product testing; (c) coordinated product recalls or other similar actions; (d) scientific, technical and regulatory matters in order to improve non-food product safety and compliance; (e) emerging issues of significant health and safety relevance; (f) standardisation-related activities; (g) exchanges of officials. 4. The Partnership Council shall use its best endeavours to establish in Annex 16, as soon as possible and preferably within six months of entry into force of this Agreement, an arrangement for the regular exchange of information between the Rapid Alert System for non-food products (RAPEX), or its successor, and the database relating to market surveillance and product safety established under the General Product Safety Regulations 2005, or its successor, in relation to the safety of non-food products and related preventive, restrictive and corrective measures. The arrangement shall set out the modalities under which: (a) the Union is to provide the United Kingdom with selected information from its RAPEX alert system, or its successor, as referred to in Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, or its successor; (b) the United Kingdom is to provide the Union with selected information from its database relating to market surveillance and product safety established under the General Product Safety Regulations 2005, or its successor; and (c) the Parties are to inform each other of any follow-up actions and measures taken in response to the information exchanged. 5. The Partnership Council may establish in Annex 17 an arrangement on the regular exchange of information, including the exchange of information by electronic means, regarding measures taken on non-compliant non-food products, other than those covered by paragraph 4. 6. Each Party shall use the information obtained pursuant to paragraphs 3, 4 and 5 for the sole purpose of protecting consumers, health, safety or the environment. 7. Each Party shall treat the information obtained pursuant to paragraphs 3, 4 and 5 as confidential. 8. The arrangements referred to in paragraphs 4 and 5 shall specify the type of information to be exchanged, the modalities for the exchange and the application of confidentiality and personal data protection rules. The Partnership Council shall have the power to adopt decisions in order to determine or amend the arrangements set out in Annexes 16 and 17. 9. For the purposes of this Article, \"market surveillance\" means activities conducted and measures taken by market surveillance and enforcement authorities, including activities conducted and measures taken in cooperation with economic operators, on the basis of procedures of a Party to enable that Party to monitor or address safety of products and their compliance with the requirements set out in its laws and regulations. 10. Each Party shall ensure that any measure taken by its market surveillance or enforcement authorities to withdraw or recall from its market or to prohibit or restrict the making available on its market of a product imported from the territory of the other Party, for reasons related to non-compliance with the applicable legislation, is proportionate, states the exact grounds on which the measure is based and is communicated without delay to the relevant economic operator. Article 97 Technical discussions 1. If a Party considers that a draft or proposed technical regulation or conformity assessment procedure of the other Party might have a significant effect on trade between the Parties, it may request technical discussions on the matter. The request shall be made in writing to the other Party and shall identify: (a) the measure at issue; (b) the provisions of this Chapter or of an Annex to this Chapter to which the concerns relate; and (c) the reasons for the request, including a description of the requesting Party's concerns regarding the measure. 2. A Party shall deliver its request to the contact point of the other Party designated pursuant to Article 99. 3. At the request of either Party, the Parties shall meet to discuss the concerns raised in the request, in person or via videoconference or teleconference, within 60 days of the date of the request and shall endeavour to resolve the matter as expeditiously as possible. If a requesting Party believes that the matter is urgent, it may request that any meeting take place within a shorter time frame. In such cases, the responding Party shall give positive consideration to such a request. Article 98 Cooperation 1. The Parties shall cooperate in the field of technical regulations, standards and conformity assessment procedures, where it is in their mutual interest, and without prejudice to the autonomy of their own respective decision-making and legal orders. The Trade Specialised Committee on Technical Barriers to Trade may exchange views with respect to the cooperation activities carried out under this Article or the Annexes to this Chapter. 2. For the purposes of paragraph 1, the Parties shall seek to identify, develop and promote cooperation activities of mutual interest. These activities may in particular relate to: (a) the exchange of information, experience and data related to technical regulations, standards and conformity assessment procedures; (b) ensuring efficient interaction and cooperation of their respective regulatory authorities at international, regional or national level; (c) exchanging information, to the extent possible, about international agreements and arrangements regarding technical barriers to trade to which one or both Parties are party; and (d) establishment of or participation in trade facilitating initiatives. 3. For the purposes of this Article and the provisions on cooperation under the Annexes to this Chapter, the European Commission shall act on behalf of the Union. Article 99 Contact points 1. Upon the entry into force of this Agreement, each Party shall designate a contact point for the implementation of this Chapter and shall notify the other Party of the contact details for the contact point, including information regarding the relevant officials. The Parties shall promptly notify each other of any change of those contact details. 2. The contact point shall provide any information or explanation requested by the contact point of the other Party in relation to the implementation of this Chapter within a reasonable period of time and, if possible, within 60 days of the date of receipt of the request. Article 100 Trade Specialised Committee on Technical Barriers to Trade The Trade Specialised Committee on Technical Barriers to Trade shall supervise the implementation and operation of this Chapter and its Annexes and shall promptly clarify and address, where possible, any issue raised by a Party relating to the development, adoption or application of technical regulations, standards and conformity assessment procedures under this Chapter or the TBT Agreement. CHAPTER 5 CUSTOMS AND TRADE FACILITATION Article 101 Objective The objectives of this Chapter are: (a) to reinforce cooperation between the Parties in the area of customs and trade facilitation and to support or maintain, where relevant, appropriate levels of compatibility of their customs legislation and practices with a view to ensuring that relevant legislation and procedures, as well as the administrative capacity of the relevant administrations, fulfil the objectives of promoting trade facilitation while ensuring effective customs controls and effective enforcement of customs legislation and trade related laws and regulations, the proper protection of security and safety of citizens and the respect of prohibitions and restrictions and financial interests of the Parties; (b) to reinforce administrative cooperation between the Parties in the field of VAT and mutual assistance in claims related to taxes and duties; (c) to ensure that the legislation of each Party is non-discriminatory and that customs procedures are based upon the use of modern methods and effective controls to combat fraud and to promote legitimate trade; and (d) to ensure that legitimate public policy objectives, including in relation to security, safety and the fight against fraud are not compromised in any way. Article 102 Definitions For the purposes of this Chapter and Annex 18 and the Protocol on mutual administrative assistance in customs matters and the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties, the following definitions apply: (a) \"Agreement on Pre-shipment Inspection\" means the Agreement on Pre-shipment Inspection, contained in Annex 1A to the WTO Agreement; (b) \"ATA and Istanbul Conventions\" means the Customs Convention on the ATA Carnet for the Temporary Admission of Goods done in Brussels on 6 December 1961 and the Istanbul Convention on Temporary Admission done on 26 June 1990; (c) \"Common Transit Convention\" means the Convention of 20 May 1987 on a common transit procedure; (d) \"Customs Data Model of the WCO\" means the library of data components and electronic templates for the exchange of business data and compilation of international standards on data and information used in applying regulatory facilitation and controls in global trade, as published by the WCO Data Model Project Team from time to time; (e) \"customs legislation\" means any legal or regulatory provision applicable in the territory of either Party, governing the entry or import of goods, exit or export of goods, the transit of goods and the placing of goods under any other customs regime or procedure, including measures of prohibition, restriction and control; (f) \"information\" means any data, document, image, report, communication or authenticated copy, in any format, including in electronic format, whether or not processed or analysed; (g) \"person\" means any person as defined in point (l) of Article 512 (5); (h) \"SAFE Framework\" means the SAFE Framework of Standards to Secure and Facilitate Global Trade adopted at the June 2005 World Customs Organisation Session in Brussels and as updated from time to time; and (i) \"WTO Trade Facilitation Agreement\" means the Agreement on Trade Facilitation annexed to the Protocol Amending the WTO Agreement (decision of 27 November 2014). Article 103 Customs cooperation 1. The relevant authorities of the Parties shall cooperate on customs matters to support the objectives set out in Article 101, taking into account the resources of their respective authorities. For the purpose of this Title, the Convention of 20 May 1987 on the Simplification of Formalities in Trade in Goods applies. 2. The Parties shall develop cooperation, including in the following areas: (a) exchanging information concerning customs legislation, the implementation of customs legislation and customs procedures; particularly in the following areas: (i) the simplification and modernisation of customs procedures; (ii) the facilitation of transit movements and transhipment; (iii) relations with the business community; and (iv) supply chain security and risk management; (b) working together on the customs-related aspects of securing and facilitating the international trade supply chain in accordance with the SAFE Framework; (c) considering developing joint initiatives relating to import, export and other customs procedures including technical assistance, as well as towards ensuring an effective service to the business community; (d) strengthening their cooperation in the field of customs in international organisations such as the WTO and the WCO, and exchanging information or holding discussions with a view to establishing where possible common positions in those international organisations and in UNCTAD, UNECE; (e) endeavouring to harmonise their data requirements for import, export and other customs procedures by implementing common standards and data elements in accordance with the Customs Data Model of the WCO; (f) strengthening their cooperation on risk management techniques, including sharing best practices, and, where appropriate, risk information and control results. Where relevant and appropriate, the Parties may also consider mutual recognition of risk management techniques, risk standards and controls and customs security measures; the Parties may also consider, where relevant and appropriate, the development of compatible risk criteria and standards, control measures and priority control areas; (g) establishing mutual recognition of Authorised Economic Operator programmes to secure and facilitate trade; (h) fostering cooperation between customs and other government authorities or agencies in relation to Authorised Economic Operator programmes, which may be achieved, inter alia, by agreeing on the highest standards, facilitating access to benefits and minimising unnecessary duplication; (i) enforcing intellectual property rights by customs authorities, including exchanging information and best practices in customs operations focusing in particular on intellectual property rights enforcement; (j) maintaining compatible customs procedures, where appropriate and practicable to do so, including the application of a single administrative document for customs declaration; and (k) exchanging, where relevant and appropriate and under arrangements to be agreed, certain categories of customs-related information between the customs authorities of the Parties through structured and recurrent communication, for the purposes of improving risk management and the effectiveness of customs controls, targeting goods at risk in terms of revenue collection or safety and security, and facilitating legitimate trade; such exchanges may include export and import declaration data on trade between the Parties, with the possibility of exploring, through pilot initiatives, the development of interoperable mechanisms to avoid duplication in the submission of such information. Exchanges under this point shall be without prejudice to exchanges of information that may take place between the Parties pursuant to the Protocol on mutual administrative assistance in customs matters. 3. Without prejudice to other forms of cooperation envisaged in this Agreement, the customs authorities of the Parties shall provide each other with mutual administrative assistance in the matters covered by this Chapter in accordance with the Protocol on mutual administrative assistance in customs matters. 4. Any exchange of information between the Parties under this Chapter shall be subject to the confidentiality and protection of information set out in Article 12 of the Protocol on mutual administrative assistance in customs matters, mutatis mutandis, as well as to any confidentiality requirements set out in the legislation of the Parties. Article 104 Customs and other trade related legislation and procedures 1. Each Party shall ensure that its customs provisions and procedures: (a) are consistent with international instruments and standards applicable in the area of customs and trade, including the WTO Trade Facilitation Agreement, the substantive elements of the Revised Kyoto Convention on the Simplification and Harmonisation of Customs Procedures, the International Convention on the Harmonised Commodity Description and Coding System, as well as the SAFE Framework and the Customs Data Model of the WCO; (b) provide the protection and facilitation of legitimate trade taking into account the evolution of trade practices through effective enforcement including in case of breaches of its laws and regulations, duty evasion and smuggling and through ensuring compliance with legislative requirements; (c) are based on legislation that is proportionate and non-discriminatory, avoids unnecessary burdens on economic operators, provides for further facilitation for operators with high levels of compliance including favourable treatment with respect to customs controls prior to the release of goods, and ensures safeguards against fraud and illicit or damageable activities while ensuring a high level of protection of security and safety of citizens and the respect of prohibitions and restrictions and financial interests of the Parties; and (d) contain rules that ensure that any penalty imposed for breaches of customs regulations or procedural requirements is proportionate and non-discriminatory and that the imposition of such penalties does not result in unjustified delays. Each Party should periodically review its legislation and customs procedures. Customs procedures should also be applied in a manner that is predictable, consistent and transparent. 2. In order to improve working methods and to ensure non-discrimination, transparency, efficiency, integrity and the accountability of operations, each Party shall: (a) simplify and review requirements and formalities wherever possible with a view to ensuring the rapid release and clearance of goods; (b) work towards the further simplification and standardisation of the data and documentation required by customs and other agencies; and (c) promote coordination between all border agencies, both internally and across borders, to facilitate border-crossing processes and enhance control, taking into account joint border controls where feasible and appropriate. Article 105 Release of goods 1. Each Party shall adopt or maintain customs procedures that: (a) provide for the prompt release of goods within a period that is no longer than necessary to ensure compliance with its laws and regulations; (b) provide for advance electronic submission and processing of documentation and any other required information prior to the arrival of the goods, to enable the release of goods promptly upon arrival if no risk has been identified through risk analysis or if no random checks or other checks are to be performed; (c) provide for the possibility, where appropriate and if the necessary conditions are satisfied, of releasing goods for free circulation at the first point of arrival; and (d) allow for the release of goods prior to the final determination of customs duties, taxes, fees and charges, if such a determination is not done prior to, or upon arrival, or as rapidly as possible after arrival and provided that all other regulatory requirements have been met. 2. As a condition for such release, each Party may require a guarantee for any amount not yet determined in the form of a surety, a deposit or another appropriate instrument provided for in its laws and regulations. Such guarantee shall not be greater than the amount the Party requires to ensure payment of customs duties, taxes, fees and charges ultimately due for the goods covered by the guarantee. The guarantee shall be discharged when it is no longer required. 3. The Parties shall ensure that the customs and other authorities responsible for border controls and procedures dealing with importation, exportation and transit of goods cooperate with one another and coordinate their activities in order to facilitate trade and expedite the release of goods. Article 106 Simplified customs procedures 1. Each Party shall work towards simplification of its requirements and formalities for customs procedures in order to reduce the time and costs thereof for traders or operators, including small and medium-sized enterprises. 2. Each Party shall adopt or maintain measures allowing traders or operators fulfilling criteria specified in its laws and regulations to benefit from further simplification of customs procedures. Such measures may include inter alia: (a) customs declarations containing a reduced set of data or supporting documents; (b) periodical customs declarations for the determination and payment of customs duties and taxes covering multiple imports within a given period after the release of those imported goods; (c) self-assessment of and the deferred payment of customs duties and taxes until after the release of those imported goods; and (d) the use of a guarantee with a reduced amount or a waiver from the obligation to provide a guarantee. 3. Where a Party chooses to adopt one of these measures, it will offer, where considered appropriate and practicable by that Party and in accordance with its laws and regulations, these simplifications to all traders who meet the relevant criteria. Article 107 Transit and transhipment 1. For the purposes of Article 20, the Common Transit Convention shall apply. 2. Each Party shall ensure the facilitation and effective control of transhipment operations and transit movements through their respective territories. 3. Each Party shall promote and implement regional transit arrangements with a view to facilitating trade in compliance with the Common Transit Convention. 4. Each Party shall ensure cooperation and coordination between all concerned authorities and agencies in their respective territories in order to facilitate traffic in transit. 5. Each Party shall allow goods intended for import to be moved within its territory under customs control from a customs office of entry to another customs office in its territory from where the goods would be released or cleared. Article 108 Risk management 1. Each Party shall adopt or maintain a risk management system for customs controls with a view to reducing the likelihood and the impact of an event which would prevent the correct application of customs legislation, compromise the financial interest of the Parties or pose a threat to the security and safety of the Parties and their residents, to human, animal or plant health, to the environment or to consumers. 2. Customs controls, other than random checks, shall primarily be based on risk analysis using electronic data-processing techniques. 3. Each Party shall design and apply risk management in such a manner as to avoid arbitrary or unjustifiable discrimination, or disguised restrictions to international trade. 4. Each Party shall concentrate customs controls and other relevant border controls on high-risk consignments and shall expedite the release of low-risk consignments. Each Party may also select consignments for such controls on a random basis as part of its risk management. 5. Each Party shall base risk management on the assessment of risk through appropriate selectivity criteria. Article 109 Post-clearance audit 1. With a view to expediting the release of goods, each Party shall adopt or maintain post-clearance audit to ensure compliance with customs and other related laws and regulations. 2. Each Party shall select persons and consignments for post-clearance audits in a risk-based manner, which may include using appropriate selectivity criteria. Each Party shall conduct post-clearance audits in a transparent manner. Where a person is involved in the audit process and conclusive results have been achieved, the Party shall notify the person whose record is audited of the results, the person's rights and obligations and the reasons for the results, without delay. 3. The information obtained in post-clearance audits may be used in further administrative or judicial proceedings. 4. The Parties shall, wherever practicable, use the results of post-clearance audit for risk management purposes. Article 110 Authorised Economic Operators 1. Each Party shall maintain a partnership programme for operators who meet the specified criteria in Annex 18. 2. The Parties shall recognise their respective programmes for Authorised Economic Operators in accordance with Annex 18. Article 111 Publication and availability of information 1. Each Party shall ensure that its customs legislation and other trade-related laws and regulations, as well as its general administrative procedures and relevant information of general application that relate to trade, are published and readily available to any interested person in an easily accessible manner, including, as appropriate, through the Internet. 2. Each Party shall promptly publish new legislation and general procedures related to customs and trade facilitation issues as early as possible prior to the entry into force of any such legislation or procedures, and shall promptly publish any changes to and interpretations of such legislation and procedures. Such publication shall include: (a) relevant notices of an administrative nature; (b) importation, exportation and transit procedures (including port, airport, and other entry-point procedures) and required forms and documents; (c) applied rates of duty and taxes of any kind imposed on or in connection with importation or exportation; (d) fees and charges imposed by or for governmental agencies on or in connection with importation, exportation or transit; (e) rules for the classification or valuation of products for customs purposes; (f) laws, regulations and administrative rulings of general application relating to rules of origin; (g) import, export or transit restrictions or prohibitions; (h) penalty provisions against breaches of import, export or transit formalities; (i) appeal procedures; (j) agreements or parts thereof with any country or countries relating to importation, exportation or transit; (k) procedures relating to the administration of tariff quotas; (l) hours of operation and operating procedures for customs offices at ports and border crossing points; and (m) points of contact for information enquiries. 3. Each Party shall ensure there is a reasonable time period between the publication of new or amended legislation, procedures and fees or charges and their entry into force. 4. Each Party shall make the following available through the internet: (a) a description of its importation, exportation and transit procedures, including appeal procedures, informing of the practical steps needed to import and export, and for transit; (b) the forms and documents required for importation into, exportation from, or transit through the territory of that Party; and (c) contact information regarding enquiry points. Each party shall ensure that the descriptions, forms, documents and information referred to in points (a), (b) and (c) of the first subparagraph are kept up to date. 5. Each Party shall establish or maintain one or more enquiry points to answer enquiries of governments, traders and other interested parties regarding customs and other trade-related matters within a reasonable time. The Parties shall not require the payment of a fee for answering enquiries. Article 112 Advance rulings 1. Each Party, through its customs authorities, shall issue advance rulings upon application by economic operators setting forth the treatment to be accorded to the goods concerned. Such rulings shall be issued in writing or in electronic format in a time bound manner and shall contain all necessary information in accordance with the legislation of the issuing Party. 2. Advance rulings shall be valid for a period of at least three years from the starting date of their validity unless the ruling no longer conforms to the law or the facts or circumstances supporting the original ruling have changed. 3. A Party may refuse to issue an advance ruling if the question raised in the application is the subject of an administrative or judicial review, or if the application does not relate to any intended use of the advance ruling or any intended use of a customs procedure. If a Party declines to issue an advance ruling, it shall promptly notify the applicant in writing, setting out the relevant facts and the basis for its decision. 4. Each Party shall publish, at least: (a) the requirements for applying for an advance ruling, including the information to be provided and the format; (b) the time period by which it will issue an advance ruling; and (c) the length of time for which the advance ruling is valid. 5. If a Party revokes, modifies, invalidates or annuls an advance ruling, it shall provide written notice to the applicant setting out the relevant facts and the basis for its decision. A Party shall only revoke, modify, invalidate or annul an advance ruling with retroactive effect if the ruling was based on incomplete, incorrect, false or misleading information. 6. An advance ruling issued by a Party shall be binding on that Party in respect of the applicant that sought it. The Party may provide that the advance ruling is binding on the applicant. 7. Each Party shall provide, at the written request of the holder, a review of an advance ruling or of a decision to revoke, modify or invalidate an advance ruling. 8. Each Party shall make publicly available information on advance rulings, taking into account the need to protect personal and commercially confidential information. 9. Advance rulings shall be issued with regard to: (a) the tariff classification of goods; (b) the origin of goods; and (c) any other matter the Parties may agree upon. Article 113 Customs brokers The customs provisions and procedures of a Party shall not require the mandatory use of customs brokers or other agents. Each Party shall publish its measures on the use of customs brokers. Each Party shall apply transparent, non-discriminatory and proportionate rules if and when licensing customs brokers. Article 114 Pre-shipment inspections A Party shall not require the mandatory use of pre-shipment inspections as defined in the WTO Agreement on Pre-shipment Inspection, or any other inspection activity performed at destination, by private companies, before customs clearance. Article 115 Review and appeal 1. Each Party shall provide effective, prompt, non-discriminatory and easily accessible procedures that guarantee the right of appeal against administrative actions, rulings and decisions of customs or other competent authorities that affect the import or export of goods or goods in transit. 2. The procedures referred to in paragraph 1 shall include: (a) an administrative appeal to or review by an administrative authority higher than or independent of the official or office that issued the decision; and (b) a judicial appeal or review of the decision. 3. Each Party shall ensure that, in cases where the decision on appeal or review under point (a) of paragraph 2 is not given within the time period provided for in its laws and regulations or is not given without undue delay, the petitioner has the right to further administrative or judicial appeal or review or any other recourse to judicial authority in accordance with that Party's laws and regulations. 4. Each Party shall ensure that the petitioner is provided with the reasons for the administrative decision so as to enable the petitioner to have recourse to appeal or review procedures where necessary. Article 116 Relations with the business community 1. Each Party shall hold timely and regular consultations with trade representatives on legislative proposals and general procedures related to customs and trade facilitation issues. To that end, appropriate consultation between administrations and the business community shall be maintained by each Party. 2. Each Party shall ensure that its customs and related requirements and procedures continue to meet the needs of the trading community, follow best practices, and restrict trade as little as possible. Article 117 Temporary admission 1. For the purposes of this Article, \"temporary admission\" means the customs procedure under which certain goods, including means of transport, can be brought into a customs territory with conditional relief from the payment of import duties and taxes and without the application of import prohibitions or restrictions of an economic character, on the condition that the goods are imported for a specific purpose and are intended for re-exportation within a specified period without having undergone any change except normal depreciation due to the use made of those goods. 2. Each Party shall grant temporary admission, with total conditional relief from import duties and taxes and without application of import restrictions or prohibitions of economic character, as provided for in its laws and regulations, to the following types of goods: (a) goods for display or use at exhibitions, fairs, meetings or similar events (goods intended for display or demonstration at an event; goods intended for use in connection with the display of foreign products at an event; equipment including interpretation equipment, sound and image recording apparatus and films of an educational, scientific or cultural character intended for use at international meetings, conferences or congresses); products obtained incidentally during the event from temporarily imported goods, as a result of the demonstration of displayed machinery or apparatus; (b) professional equipment (equipment for the press, for sound or television broadcasting which is necessary for representatives of the press, of broadcasting or television organisations visiting the territory of another country for purposes of reporting, in order to transmit or record material for specified programmes; cinematographic equipment necessary for a person visiting the territory of another country in order to make a specified film or films; any other equipment necessary for the exercise of the calling, trade or profession of a person visiting the territory of another country to perform a specified task, insofar as it is not to be used for the industrial manufacture or packaging of goods or (except in the case of hand tools) for the exploitation of natural resources, for the construction, repair or maintenance of buildings or for earth moving and like projects; ancillary apparatus for the equipment mentioned above, and accessories therefor); component parts imported for repair of professional equipment temporarily admitted; (c) goods imported in connection with a commercial operation but whose importation does not in itself constitute a commercial operation (packings which are imported filled for re-exportation empty or filled, or are imported empty for re-exportation filled; containers, whether or not filled with goods, and accessories and equipment for temporarily admitted containers, which are either imported with a container to be re-exported separately or with another container, or are imported separately to be re-exported with a container and component parts intended for the repair of containers granted temporary admission; pallets; samples; advertising films; other goods imported in connection with a commercial operation); (d) goods imported in connection with a manufacturing operation (matrices, blocks, plates, moulds, drawings, plans, models and other similar articles; measuring, controlling and checking instruments and other similar articles; special tools and instruments, imported for use during a manufacturing process); replacement means of production (instruments, apparatus and machines made available to a customer by a supplier or repairer, pending the delivery or repair of similar goods); (e) goods imported exclusively for educational, scientific or cultural purposes (scientific equipment, pedagogic material, welfare material for seafarers, and any other goods imported in connection with educational, scientific or cultural activities); spare parts for scientific equipment and pedagogic material which has been granted temporary admission; tools specially designed for the maintenance, checking, gauging or repair of such equipment; (f) personal effects (all articles, new or used, which a traveller may reasonably require for his or her personal use during the journey, taking into account all the circumstances of the journey, but excluding any goods imported for commercial purposes); goods imported for sports purposes (sports requisites and other articles for use by travellers in sports contests or demonstrations or for training in the territory of temporary admission); (g) tourist publicity material (goods imported for the purpose of encouraging the public to visit another foreign country, in particular in order to attend cultural, religious, touristic, sporting or professional meetings or demonstrations held there); (h) goods imported for humanitarian purposes (medical, surgical and laboratory equipment and relief consignments, such as vehicles and other means of transport, blankets, tents, prefabricated houses or other goods of prime necessity, forwarded as aid to those affected by natural disaster and similar catastrophes); and (i) animals imported for specific purposes (dressage, training, breeding, shoeing or weighing, veterinary treatment, testing (for example, with a view to purchase), participation in shows, exhibitions, contests, competitions or demonstrations, entertainment (circus animals, etc.), touring (including pet animals of travellers), exercise of function (police dogs or horses; detector dogs, dogs for the blind, etc.), rescue operations, transhumance or grazing, performance of work or transport, medical purposes (delivery of snake poison, etc.). 3. Each Party shall, for the temporary admission of the goods referred to in paragraph 2 and regardless of their origin, accept a carnet as prescribed for the purposes of the ATA and Istanbul Conventions issued in the other Party, endorsed there and guaranteed by an association forming part of the international guarantee chain, certified by the competent authorities and valid in the customs territory of the importing Party. Article 118 Single window Each Party shall endeavour to establish a single window that enables traders to submit documentation or data required for importation, exportation, or transit of goods through a single entry point to the participating authorities or agencies. Article 119 Facilitation of roll-on, roll-off traffic 1. In recognition of the high volume of sea-crossings and, in particular, the high volume of roll on, roll off traffic between their respective customs territories, the Parties agree to cooperate in order to facilitate such traffic as well as other alternative modes of traffic. 2. The Parties acknowledge: (a) the right of each Party to adopt trade facilitating customs formalities and procedures for traffic between the Parties within their respective legal frameworks; and (b) the right of ports, port authorities and operators to act, within the legal orders of their respective Parties, in accordance with their rules and their operating and business models. 3. To this effect the Parties: (a) shall adopt or maintain procedures allowing for the submission of import documentation and other required information, including manifests, in order to begin processing prior to the arrival of goods with a view to expediting the release of goods upon arrival; and (b) undertake to facilitate the use by operators of the transit procedure, including simplifications of the transit procedure as provided for under the Common Transit Convention. 4. The Parties agree to encourage cooperation between their respective customs authorities on bilateral sea-crossing routes, and to exchange information on the functioning of ports handling traffic between them and on the applicable rules and procedures. They will make public, and promote knowledge by operators of, information on the measures they have in place and the processes established by ports to facilitate such traffic. Article 120 Administrative cooperation in VAT and mutual assistance for recovery of taxes and duties The competent authorities of the Parties shall cooperate with each other to ensure compliance with VAT legislation and in recovering claims relating to taxes and duties in accordance with the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties. Article 121 Trade Specialised Committee on Customs Cooperation and Rules of Origin 1. The Trade Specialised Committee on Customs Cooperation and Rules of Origin shall: (a) hold regular consultations; and (b) in relation to the review of the provisions of Annex 18: (i) jointly validate programme members to identify strengths and weaknesses in implementing Annex 18; and (ii) exchange views on data to be shared and treatment of operators. 2. The Trade Specialised Committee on Customs Cooperation and Rules of Origin may adopt decisions or recommendations: (a) on the exchange of customs-related information, on mutual recognition of risk management techniques, risk standards and controls, customs security measures, on advanced rulings, on common approaches to customs valuation and on other issues related to the implementation of this Chapter; (b) on the arrangements relating to the automatic exchange of information as referred to in Article 10 of the Protocol on mutual administrative assistance in customs matters, and on other issues relating to the implementation of that Protocol; (c) on any issues relating to the implementation of Annex 18; and (d) on the procedures for the consultation established in Article 63 and on any technical or administrative matters relating to the implementation of Chapter 2 of this Title, including on interpretative notes aimed at ensuring the uniform administration of the rules of origin. Article 122 Amendments 1. The Partnership Council may amend: (a) Annex 18, the Protocol on mutual administrative assistance in customs matters and the list of goods set out in Article 117(2); and (b) the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties. 2. The Trade Specialised Committee on Administrative Cooperation in VAT and Recovery of Taxes and Duties may amend the value referred to in Article 33(4) of the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties. TITLE II SERVICES AND INVESTMENT CHAPTER 1 GENERAL PROVISIONS Article 123 Objective and scope 1. The Parties affirm their commitment to establish a favourable climate for the development of trade and investment between them. 2. The Parties reaffirm the right to regulate within their territories to achieve legitimate policy objectives, such as: the protection of public health; social services; public education; safety; the environment, including climate change; public morals; social or consumer protection; privacy and data protection or the promotion and protection of cultural diversity. 3. This Title does not apply to measures affecting natural persons of a Party seeking access to the employment market of the other Party or to measures regarding nationality, citizenship, residence or employment on a permanent basis. 4. This Title shall not prevent a Party from applying measures to regulate the entry of natural persons into, or their temporary stay in, its territory, including those measures necessary to protect the integrity of its borders and to ensure the orderly movement of natural persons across them, provided that such measures are not applied in such a manner as to nullify or impair the benefits accruing to the other Party under the terms of this Title. The sole fact of requiring a visa for natural persons of certain countries and not for those of others shall not be regarded as nullifying or impairing benefits under this Title. 5. This Title does not apply to: (a) air services or related services in support of air services (6), other than: (i) aircraft repair and maintenance services; (ii) computer reservation system services; (iii) ground handling services; (iv) the following services provided using a manned aircraft, subject to compliance with the Parties' respective laws and regulations governing the admission of aircrafts to, departure from and operation within, their territory: aerial fire-fighting; flight training; spraying; surveying; mapping; photography; and other airborne agricultural, industrial and inspection services; and (v) the selling and marketing of air transport services; (b) audio-visual services; (c) national maritime cabotage (7); and (d) inland waterways transport. 6. This Title does not apply to any measure of a Party with respect to public procurement of a good or service purchased for governmental purposes, and not with a view to commercial resale or with a view to use in the supply of a good or service for commercial sale, whether or not that procurement is \"covered procurement\" within the meaning of Article 277. 7. Except for Article 132, this Title does not apply to subsidies or grants provided by the Parties, including government-supported loans, guarantees and insurance. Article 124 Definitions For the purposes of this Title, the following definitions apply: (a) \"activities performed in the exercise of governmental authority\" means activities which are performed, including services which are supplied, neither on a commercial basis nor in competition with one or more economic operators; (8) (b) \"aircraft repair and maintenance services\" means such activities when undertaken on an aircraft or a part thereof while it is withdrawn from service and does not include so-called line maintenance; (c) \"computer reservation system services\" means services provided by computerised systems that contain information about air carriers' schedules, availability, fares and fare rules, through which reservations can be made or tickets may be issued; (d) \"covered enterprise\" means an enterprise in the territory of a Party established in accordance with point (h) by an investor of the other Party, in accordance with the applicable law, existing on the date of entry into force of this Agreement or established thereafter; (e) \"cross-border trade in services\" means the supply of a service: (i) from the territory of a Party into the territory of the other Party; or (ii) in the territory of a Party to the service consumer of the other Party; (f) \"economic activity\" means any activity of an industrial, commercial or professional character or activities of craftsmen, including the supply of services, except for activities performed in the exercise of governmental authority; (g) \"enterprise\" means a legal person or a branch or a representative office of a legal person; (h) \"establishment\" means the setting up or the acquisition of a legal person, including through capital participation, or the creation of a branch or representative office in the territory of a Party, with a view to creating or maintaining lasting economic links; (i) \"ground handling services\" means the supply at an airport, on a fee or contract basis, of the following services: airline representation, administration and supervision; passenger handling; baggage handling; ramp services; catering; air cargo and mail handling; fuelling of an aircraft; aircraft servicing and cleaning; surface transport; and flight operations, crew administration and flight planning; ground handling services do not include: self-handling; security; aircraft repair and maintenance; or management or operation of essential centralised airport infrastructure, such as de-icing facilities, fuel distribution systems, baggage handling systems and fixed intra airport transport systems; (j) \"investor of a Party\" means a natural or legal person of a Party that seeks to establish, is establishing or has established an enterprise in accordance with point (h) in the territory of the other Party; (k) \"legal person of a Party\" (9) means: (i) for the Union: (A) a legal person constituted or organised under the law of the Union or at least one of its Member States and engaged, in the territory of the Union, in substantive business operations, understood by the Union, in line with its notification of the Treaty establishing the European Community to the WTO (WT/REG39/1), as equivalent to the concept of \"effective and continuous link\" with the economy of a Member State enshrined in Article 54 of the Treaty on the Functioning of the European Union (TFEU); and (B) shipping companies established outside the Union, and controlled by natural persons of a Member State, whose vessels are registered in, and fly the flag of, a Member State; (ii) for the United Kingdom: (A) a legal person constituted or organised under the law of the United Kingdom and engaged in substantive business operations in the territory of the United Kingdom; and (B) shipping companies established outside the United Kingdom and controlled by natural persons of the United Kingdom, whose vessels are registered in, and fly the flag of, the United Kingdom; (l) \"operation\" means the conduct, management, maintenance, use, enjoyment, or sale or other form of disposal of an enterprise; (m) \"professional qualifications\" means qualifications attested by evidence of formal qualification, professional experience, or other attestation of competence; (n) \"selling and marketing of air transport services\" means opportunities for the air carrier concerned to sell and market freely its air transport services including all aspects of marketing such as market research, advertising and distribution, but not including the pricing of air transport services nor the applicable conditions; (o) \"service\" means any service in any sector except services supplied in the exercise of governmental authority; (p) \"services supplied in the exercise of governmental authority\" means any service which is supplied neither on a commercial basis, nor in competition with one or more service suppliers; (q) \"service supplier\" means any natural or legal person that seeks to supply or supplies a service; (r) \"service supplier of a Party\" means a natural or legal person of a Party that seeks to supply or supplies a service. Article 125 Denial of benefits 1. A Party may deny the benefits of this Title and Title IV of this Heading to an investor or service supplier of the other Party, or to a covered enterprise, if the denying Party adopts or maintains measures related to the maintenance of international peace and security, including the protection of human rights, which: (a) prohibit transactions with that investor, service supplier or covered enterprise; or (b) would be violated or circumvented if the benefits of this Title and Title IV of this Heading were accorded to that investor, service supplier or covered enterprise, including where the measures prohibit transactions with a natural or legal person which owns or controls any of them. 2. For greater certainty, paragraph 1 is applicable to Title IV of this Heading to the extent that it relates to services or investment with respect to which a Party has denied the benefits of this Title. Article 126 Review 1. With a view to introducing possible improvements to the provisions of this Title, and consistent with their commitments under international agreements, the Parties shall review their legal framework relating to trade in services and investment, including this Agreement, in accordance with Article 776. 2. The Parties shall endeavour, where appropriate, to review the non-conforming measures and reservations set out in Annexes 19, 20, 21 and 22 and the activities for short term business visitors set out in Annex 21, with a view to agreeing to possible improvements in their mutual interest. 3. This Article shall not apply with respect to financial services. CHAPTER 2 INVESTMENT LIBERALISATION Article 127 Scope This Chapter applies to measures of a Party affecting the establishment of an enterprise to perform economic activities and the operation of such an enterprise by: (a) investors of the other Party; (b) covered enterprises; and (c) for the purposes of Article 132, any enterprise in the territory of the Party which adopts or maintains the measure. Article 128 Market access A Party shall not adopt or maintain, with regard to establishment of an enterprise by an investor of the other Party or by a covered enterprise, or operation of a covered enterprise, either on the basis of its entire territory or on the basis of a territorial sub-division, measures that: (a) impose limitations on: (i) the number of enterprises that may carry out a specific economic activity, whether in the form of numerical quotas, monopolies, exclusive rights or the requirement of an economic needs test; (ii) the total value of transactions or assets in the form of numerical quotas or the requirement of an economic needs test; (iii) the total number of operations or on the total quantity of output expressed in terms of designated numerical units in the form of quotas or the requirement of an economic needs test; (10) (11) (iv) the participation of foreign capital in terms of maximum percentage limit on foreign shareholding or the total value of individual or aggregate foreign investment; or (v) the total number of natural persons that may be employed in a particular sector or that an enterprise may employ and who are necessary for, and directly related to, the performance of an economic activity, in the form of numerical quotas or the requirement of an economic needs test; or (b) restrict or require specific types of legal entity or joint venture through which an investor of the other Party may perform an economic activity. Article 129 National treatment 1. Each Party shall accord to investors of the other Party and to covered enterprises treatment no less favourable than that it accords, in like situations, to its own investors and to their enterprises, with respect to their establishment and operation in its territory. 2. The treatment accorded by a Party under paragraph 1 means: (a) with respect to a regional or local level of government of the United Kingdom, treatment no less favourable than the most favourable treatment accorded, in like situations, by that level of government to investors of the United Kingdom and to their enterprises in its territory; and (b) with respect to a government of, or in, a Member State, treatment no less favourable than the most favourable treatment accorded, in like situations, by that government to investors of that Member State and to their enterprises in its territory. Article 130 Most-favoured-nation-treatment 1. Each Party shall accord to investors of the other Party and to covered enterprises treatment no less favourable than that it accords, in like situations, to investors of a third country and to their enterprises, with respect to establishment in its territory. 2. Each Party shall accord to investors of the other Party and to covered enterprises treatment no less favourable than that it accords, in like situations, to investors of a third country and to their enterprises, with respect to operation in its territory. 3. Paragraphs 1 and 2 shall not be construed as obliging a Party to extend to investors of the other Party or to covered enterprises the benefit of any treatment resulting from: (a) an international agreement for the avoidance of double taxation or other international agreement or arrangement relating wholly or mainly to taxation; or (b) measures providing for recognition, including the recognition of the standards or criteria for the authorisation, licencing, or certification of a natural person or enterprise to carry out an economic activity, or the recognition of prudential measures as referred to in paragraph 3 of the GATS Annex on Financial Services. 4. For greater certainty, the \"treatment\" referred to in paragraphs 1 and 2 does not include investor-to-state dispute settlement procedures provided for in other international agreements. 5. For greater certainty, the existence of substantive provisions in other international agreements concluded by a Party with a third country, or the mere formal transposition of those provisions into domestic law to the extent that it is necessary in order to incorporate them into the domestic legal order, do not in themselves constitute the \"treatment\" referred to in paragraphs 1 and 2. Measures of a Party pursuant to those provisions may constitute such treatment and thus give rise to a breach of this Article. Article 131 Senior management and boards of directors A Party shall not require a covered enterprise to appoint individuals of any particular nationality as executives, managers or members of boards of directors. Article 132 Performance requirements 1. A Party shall not impose or enforce any requirement, or enforce any commitment or undertaking, in connection with the establishment or operation of any enterprise in its territory: (a) to export a given level or percentage of goods or services; (b) to achieve a given level or percentage of domestic content; (c) to purchase, use or accord a preference to goods produced or services provided in its territory or to purchase goods or services from natural or legal persons or any other entities in its territory; (d) to relate in any way the volume or value of imports to the volume or value of exports or to the amount of foreign exchange inflows associated with such enterprise; (e) to restrict sales of goods or services in its territory that such enterprise produces or supplies, by relating those sales in any way to the volume or value of its exports or foreign exchange inflows; (f) to transfer technology, a production process or other proprietary knowledge to a natural or legal person or any other entity in its territory (12); (g) to supply exclusively from the territory of that Party a good produced or a service supplied by the enterprise to a specific regional or world market; (h) to locate the headquarters for a specific region of the world which is broader than the territory of the Party or the world market in its territory; (i) to employ a given number or percentage of natural persons of that Party; (j) to achieve a given level or value of research and development in its territory; (k) to restrict the exportation or sale for export; or (l) with regard to any licence contract in existence at the time the requirement is imposed or enforced, or any commitment or undertaking is enforced, or with regard to any future licence contract freely entered into between the enterprise and a natural or legal person or any other entity in its territory, if the requirement is imposed or enforced or the commitment or undertaking is enforced, in a manner that constitutes direct interference with that licence contract by an exercise of non-judicial governmental authority of a Party, to adopt: (i) a rate or amount of royalty below a certain level; or (ii) a given duration of the term of a licence contract. This point does not apply where the licence contract is concluded between the enterprise and the Party. For the purposes of this point, a \"licence contract\" means any contract concerning the licensing of technology, a production process, or other proprietary knowledge. 2. A Party shall not condition the receipt or continued receipt of an advantage, in connection with the establishment or operation of an enterprise in its territory, on compliance with any of the following requirements: (a) achieving a given level or percentage of domestic content; (b) purchasing, using or according a preference to goods produced or services supplied in its territory, or to purchase goods or services from natural or legal persons or any other entity in its territory; (c) relating in any way the volume or value of imports to the volume or value of exports or to the amount of foreign exchange inflows associated with that enterprise; (d) restricting the sales of goods or services in its territory that that enterprise produces or supplies by relating those sales in any way to the volume or value of its exports or foreign exchange inflows; or (e) restricting the exportation or sale for export. 3. Paragraph 2 shall not be construed as preventing a Party from conditioning the receipt or continued receipt of an advantage, in connection with the establishment or operation of any enterprise in its territory, on compliance with a requirement to locate production, supply a service, train or employ workers, construct or expand particular facilities, or carry out research and development, in its territory. 4. Points (f) and (l) of paragraph 1 of this Article do not apply where: (a) the requirement is imposed or enforced, or the commitment or undertaking is enforced, by a court or administrative tribunal, or by a competition authority pursuant to a Party's competition law to prevent or remedy a restriction or a distortion of competition; or (b) a Party authorises the use of an intellectual property right in accordance with Article 31 or Article 31bis of the TRIPS Agreement, or adopts or maintains measures requiring the disclosure of data or proprietary information that fall within the scope of, and are consistent with, paragraph 3 of Article 39 of the TRIPS Agreement. 5. Points (a) to (c) of paragraph 1 and points (a) and (b) of paragraph 2 do not apply to qualification requirements for goods or services with respect to participation in export promotion and foreign aid programmes. 6. For greater certainty, this Article does not preclude the enforcement by the competent authorities of a Party of any commitment or undertaking given between persons other than a Party which was not directly or indirectly imposed or required by that Party. 7. For greater certainty, points (a) and (b) of paragraph 2 do not apply to requirements imposed by an importing Party in relation to the content of goods necessary to qualify for preferential tariffs or preferential quotas. 8. Point (l) of paragraph 1 does not apply if the requirement is imposed or enforced, or the commitment or undertaking is enforced, by a tribunal as equitable remuneration under the Party's copyright laws. 9. A Party shall neither impose nor enforce any measure inconsistent with its obligations under the Agreement on Trade-Related Investment Measures (TRIMs), even where such measure has been listed by that Party in Annex 19 or 20. 10. For greater certainty, this Article shall not be construed as requiring a Party to permit a particular service to be supplied on a cross-border basis where that Party adopts or maintains restrictions or prohibitions on such provision of services which are consistent with the reservations, conditions or qualifications specified with respect to a sector, subsector or activity listed in Annex 19 or 20. 11. A condition for the receipt or continued receipt of an advantage referred to in paragraph 2 does not constitute a requirement or a commitment or undertaking for the purposes of paragraph 1. Article 133 Non-conforming measures and exceptions 1. Articles 128, 129, 130, 131 and 132 do not apply to: (a) any existing non-conforming measure of a Party at the level of: (i) for the Union: (A) the Union, as set out in the Schedule of the Union in Annex 19; (B) The central government of a Member State, as set out in the Schedule of the Union in Annex 19; (C) a regional government of a Member State, as set out in the Schedule of the Union in Annex 19; or (D) a local government, other than that referred to in point (C); and (ii) for the United Kingdom: (A) the central government, as set out in the Schedule of the United Kingdom in Annex 19; (B) a regional government, as set out in the Schedule of the United Kingdom in Annex 19; or (C) a local government; (b) the continuation or prompt renewal of any non-conforming measure referred to in point (a) of this paragraph; or (c) a modification to any non-conforming measure referred to in points (a) and (b) of this paragraph, to the extent that it does not decrease the conformity of the measure, as it existed immediately before the modification, with Article 128, 129, 130, 131 or 132. 2. Articles 128, 129, 130, 131 and 132 do not apply to a measure of a Party which is consistent with the reservations, conditions or qualifications specified with respect to a sector, subsector or activity listed in Annex 20. 3. Articles 129 and 130 of this Agreement do not apply to any measure that constitutes an exception to, or a derogation from, Article 3 or 4 of the TRIPS Agreement, as specifically provided for in Articles 3 to 5 of that Agreement. 4. For greater certainty, Articles 129 and 130 shall not be construed as preventing a Party from prescribing information requirements, including for statistical purposes, in connection with the establishment or operation of investors of the other Party or of covered enterprises, provided that it does not constitute a means to circumvent that Party's obligations under those Articles. CHAPTER 3 CROSS-BORDER TRADE IN SERVICES Article 134 Scope This Chapter applies to measures of a Party affecting the cross-border trade in services by service suppliers of the other Party. Article 135 Market access A Party shall not adopt or maintain, either on the basis of its entire territory or on the basis of a territorial sub-division, measures that: (a) impose limitations on: (i) the number of service suppliers that may supply a specific service, whether in the form of numerical quotas, monopolies, exclusive service suppliers or the requirement of an economic needs test; (ii) the total value of service transactions or assets in the form of numerical quotas or the requirement of an economic needs test; or (iii) the total number of service operations or on the total quantity of service output expressed in the terms of designated numerical units in the form of quotas or the requirement of an economic needs test (13); or (b) restrict or require specific types of legal entity or joint venture through which a service supplier may supply a service. Article 136 Local presence A Party shall not require a service supplier of the other Party to establish or maintain an enterprise or to be resident in its territory as a condition for the cross-border supply of a service. Article 137 National treatment 1. Each Party shall accord to services and service suppliers of the other Party treatment no less favourable than that it accords, in like situations, to its own services and service suppliers. 2. A Party may meet the requirement of paragraph 1 by according to services and service suppliers of the other Party either formally identical treatment or formally different treatment to that it accords to its own services and service suppliers. 3. Formally identical or formally different treatment shall be considered to be less favourable if it modifies the conditions of competition in favour of services or service suppliers of the Party compared to services or service suppliers of the other Party. 4. Nothing in this Article shall be construed as requiring either Party to compensate for inherent competitive disadvantages which result from the foreign character of the relevant services or service suppliers. Article 138 Most-favoured-nation treatment 1. Each Party shall accord to services and service suppliers of the other Party treatment no less favourable than that it accords, in like situations, to services and service suppliers of a third country. 2. Paragraph 1 shall not be construed as obliging a Party to extend to services and service suppliers of the other Party the benefit of any treatment resulting from: (a) an international agreement for the avoidance of double taxation or other international agreement or arrangement relating wholly or mainly to taxation; or (b) measures providing for recognition, including of the standards or criteria for the authorisation, licencing, or certification of a natural person or enterprise to carry out an economic activity, or of prudential measures as referred to in paragraph 3 of the GATS Annex on Financial Services. 3. For greater certainty, the existence of substantive provisions in other international agreements concluded by a Party with a third country, or mere formal transposition of those provisions into domestic law to the extent that it is necessary in order to incorporate them into the domestic legal order, do not in themselves constitute the \"treatment\" referred to in paragraph 1. Measures of a Party pursuant to those provisions may constitute such treatment and thus give rise to a breach of this Article. Article 139 Non-conforming measures 1. Articles 135, 136, 137 and 138 do not apply to: (a) any existing non-conforming measure of a Party at the level of: (i) for the Union: (A) the Union, as set out in the Schedule of the Union in Annex 19; (B) the central government of a Member State, as set out in the Schedule of the Union in Annex 19; (C) a regional government of a Member State, as set out in the Schedule of the Union in Annex 19; or (D) a local government, other than that referred to in point (C); and (ii) for the United Kingdom: (A) the central government, as set out in the Schedule of the United Kingdom in Annex 19; (B) a regional government, as set out in the Schedule of the United Kingdom in Annex 19; or (C) a local government; (b) the continuation or prompt renewal of any non-conforming measure referred to in point (a) of this paragraph; or (c) a modification to any non-conforming measure referred to in points (a) and (b) of this paragraph to the extent that it does not decrease the conformity of the measure, as it existed immediately before the modification, with Articles 135, 136, 137 and 138. 2. Articles 135, 136, 137 and 138 do not apply to any measure of a Party which is consistent with the reservations, conditions or qualifications specified with respect to a sector, subsector or activity listed in Annex 20. CHAPTER 4 ENTRY AND TEMPORARY STAY OF NATURAL PERSONS FOR BUSINESS PURPOSES Article 140 Scope and definitions 1. This Chapter applies to measures of a Party affecting the performance of economic activities through the entry and temporary stay in its territory of natural persons of the other Party, who are business visitors for establishment purposes, contractual service suppliers, independent professionals, intra-corporate transferees and short-term business visitors. 2. To the extent that commitments are not undertaken in this Chapter, all requirements provided for in the law of a Party regarding the entry and temporary stay of natural persons shall continue to apply, including laws and regulations concerning the period of stay. 3. Notwithstanding the provisions of this Chapter, all requirements provided for in the law of a Party regarding work and social security measures shall continue to apply, including laws and regulations concerning minimum wages and collective wage agreements. 4. Commitments on the entry and temporary stay of natural persons for business purposes do not apply in cases where the intent or effect of the entry and temporary stay is to interfere with or otherwise affect the outcome of any labour or management dispute or negotiation, or the employment of any natural person who is involved in that dispute. 5. For the purposes of this Chapter: (a) \"business visitors for establishment purposes\" means natural persons working in a senior position within a legal person of a Party, who: (i) are responsible for setting up an enterprise of such legal person in the territory of the other Party; (ii) do not offer or provide services or engage in any economic activity other than that which is required for the purposes of the establishment of that enterprise; and (iii) do not receive remuneration from a source located within the other Party; (b) \"contractual service suppliers\" means natural persons employed by a legal person of a Party (other than through an agency for placement and supply services of personnel), which is not established in the territory of the other Party and has concluded a bona fide contract, not exceeding 12 months, to supply services to a final consumer in the other Party requiring the temporary presence of its employees who: (i) have offered the same type of services as employees of the legal person for a period of not less than one year immediately preceding the date of their application for entry and temporary stay; (ii) possess, on that date, at least three years professional experience, obtained after having reached the age of majority, in the sector of activity that is the object of the contract, a university degree or a qualification demonstrating knowledge of an equivalent level and the professional qualifications legally required to exercise that activity in the other Party (14); and (iii) do not receive remuneration from a source located within the other Party; (c) \"independent professionals\" means natural persons engaged in the supply of a service and established as self-employed in the territory of a Party who: (i) have not established in the territory of the other Party; (ii) have concluded a bona fide contract (other than through an agency for placement and supply services of personnel) for a period not exceeding 12 months to supply services to a final consumer in the other Party, requiring their presence on a temporary basis; and (iii) possess, on the date of their application for entry and temporary stay, at least six years professional experience in the relevant activity, a university degree or a qualification demonstrating knowledge of an equivalent level and the professional qualifications legally required to exercise that activity in the other Party (15); (d) \"intra-corporate transferees\" means natural persons, who: (i) have been employed by a legal person of a Party, or have been partners in it, for a period, immediately preceding the date of the intra-corporate transfer, of not less than one year in the case of managers and specialists and of not less than six months in the case of trainee employees; (ii) at the time of application reside outside the territory of the other Party; (iii) are temporarily transferred to an enterprise of the legal person in the territory of the other Party which is a member of the same group as the originating legal person, including its representative office, subsidiary, branch or head company (16); and (iv) belong to one of the following categories: (A) managers (17); (B) specialists; or (C) trainee employees; (e) \"manager\" means a natural person working in a senior position, who primarily directs the management of the enterprise in the other Party, receiving general supervision or direction principally from the board of directors or from shareholders of the business or their equivalent and whose responsibilities include: (i) directing the enterprise or a department or subdivision thereof; (ii) supervising and controlling the work of other supervisory, professional or managerial employees; and (iii) having the authority to recommend hiring, dismissing or other personnel-related actions; (f) \"specialist\" means a natural person possessing specialised knowledge, essential to the enterprise's areas of activity, techniques or management, which is to be assessed taking into account not only knowledge specific to the enterprise, but also whether the person has a high level of qualification, including adequate professional experience of a type of work or activity requiring specific technical knowledge, including possible membership of an accredited profession; and (g) \"trainee employee\" means a natural person possessing a university degree who is temporarily transferred for career development purposes or to obtain training in business techniques or methods and is paid during the period of the transfer. (18) 6. The service contract referred to in points (b) and (c) of paragraph 5 shall comply with the requirements of the law of the Party where the contract is executed. Article 141 Intra-corporate transferees and business visitors for establishment purposes 1. Subject to the relevant conditions and qualifications specified in Annex 21: (a) each Party shall allow: (i) the entry and temporary stay of intra-corporate transferees; (ii) the entry and temporary stay of business visitors for establishment purposes without requiring a work permit or other prior approval procedure of similar intent; and (iii) the employment in its territory of intra-corporate transferees of the other Party; (b) a Party shall not maintain or adopt limitations in the form of numerical quotas or economic needs tests regarding the total number of natural persons that, in a specific sector, are allowed entry as business visitors for establishment purposes or that an investor of the other Party may employ as intra-corporate transferees, either on the basis of a territorial subdivision or on the basis of its entire territory; and (c) each Party shall accord to intra-corporate transferees and business visitors for establishment purposes of the other Party, during their temporary stay in its territory, treatment no less favourable than that it accords, in like situations, to its own natural persons. 2. The permissible length of stay shall be for a period of up to three years for managers and specialists, up to one year for trainee employees and up to 90 days within any six-month period for business visitors for establishment purposes. Article 142 Short-term business visitors 1. Subject to the relevant conditions and qualifications specified in Annex 21, each Party shall allow the entry and temporary stay of short-term business visitors of the other Party for the purposes of carrying out the activities listed in Annex 21, subject to the following conditions: (a) the short-term business visitors are not engaged in selling their goods or supplying services to the general public; (b) the short-term business visitors do not, on their own behalf, receive remuneration from within the Party where they are staying temporarily; and (c) the short-term business visitors are not engaged in the supply of a service in the framework of a contract concluded between a legal person that has not established in the territory of the Party where they are staying temporarily, and a consumer there, except as provided for in Annex 21. 2. Unless otherwise specified in Annex 21, a Party shall allow entry of short-term business visitors without the requirement of a work permit, economic needs test or other prior approval procedures of similar intent. 3. If short-term business visitors of a Party are engaged in the supply of a service to a consumer in the territory of the Party where they are staying temporarily in accordance with Annex 21, that Party shall accord to them, with regard to the supply of that service, treatment no less favourable than that it accords, in like situations, to its own service suppliers. 4. The permissible length of stay shall be for a period of up to 90 days in any six-month period. Article 143 Contractual service suppliers and independent professionals 1. In the sectors, subsectors and activities specified in Annex 22 and subject to the relevant conditions and qualifications specified therein: (a) a Party shall allow the entry and temporary stay of contractual service suppliers and independent professionals in its territory; (b) a Party shall not adopt or maintain limitations on the total number of contractual service suppliers and independent professionals of the other Party allowed entry and temporary stay, in the form of numerical quotas or an economic needs test; and (c) each Party shall accord to contractual service suppliers and independent professionals of the other Party, with regard to the supply of their services in its territory, treatment no less favourable than that it accords, in like situations, to its own service suppliers. 2. Access accorded under this Article relates only to the service which is the subject of the contract and does not confer entitlement to use the professional title of the Party where the service is provided. 3. The number of persons covered by the service contract shall not be greater than necessary to fulfil the contract, as it may be required by the law of the Party where the service is supplied. 4. The permissible length of stay shall be for a cumulative period of 12 months, or for the duration of the contract, whichever is less. Article 144 Non-conforming measures To the extent that the relevant measure affects the temporary stay of natural persons for business purposes, points (b) and (c) of Article 141(1), Article 142(3) and points (b) and (c) of Article 143(1) do not apply to: (a) any existing non-conforming measure of a Party at the level of: (i) for the Union: (A) the Union, as set out in the Schedule of the Union in Annex 19; (B) the central government of a Member State, as set out in the Schedule of the Union in Annex 19; (C) a regional government of a Member State, as set out in the Schedule of the Union in Annex 19; or (D) a local government, other than that referred to in point (C); and (ii) for the United Kingdom: (A) the central government, as set out in the Schedule of the United Kingdom in Annex 19; (B) a regional subdivision, as set out in the Schedule of the United Kingdom in Annex 19; or (C) a local government; (b) the continuation or prompt renewal of any non-conforming measure referred to in point (a) of this Article; (c) a modification to any non-conforming measure referred to in points (a) and (b) of this Article to the extent that it does not decrease the conformity of the measure, as it existed immediately before the modification, with points (b) and (c) of Article 141(1), Article 142(3) and points (b) and (c) of Article 143(1); or (d) any measure of a Party consistent with a condition or qualification specified in Annex 20. Article 145 Transparency 1. Each Party shall make publicly available information on relevant measures that pertain to the entry and temporary stay of natural persons of the other Party, referred to in Article 140(1). 2. The information referred to in paragraph 1 shall, to the extent possible, include the following information relevant to the entry and temporary stay of natural persons: (a) categories of visa, permits or any similar type of authorisation regarding the entry and temporary stay; (b) documentation required and conditions to be met; (c) method of filing an application and options on where to file, such as consular offices or online; (d) application fees and an indicative timeframe of the processing of an application; (e) the maximum length of stay under each type of authorisation described in point (a); (f) conditions for any available extension or renewal; (g) rules regarding accompanying dependants; (h) available review or appeal procedures; and (i) relevant laws of general application pertaining to the entry and temporary stay of natural persons for business purposes. 3. With respect to the information referred to in paragraphs 1 and 2, each Party shall endeavour to promptly inform the other Party of the introduction of any new requirements and procedures or of the changes in any requirements and procedures that affect the effective application for the grant of entry into, temporary stay in and, where applicable, permission to work in the former Party. CHAPTER 5 REGULATORY FRAMEWORK SECTION 1 DOMESTIC REGULATION Article 146 Scope and definitions 1. This Section applies to measures by the Parties relating to licensing requirements and procedures, qualification requirements and procedures, formalities and technical standards that affect: (a) cross-border trade in services; (b) establishment or operation; or (c) the supply of a service through the presence of a natural person of a Party in the territory of the other Party as set out in Article 140. As far as measures relating to technical standards are concerned, this Section only applies to measures that affect trade in services. For the purposes of this Section, the term \"technical standards\" does not include regulatory or implementing technical standards for financial services. 2. This Section does not apply to licensing requirements and procedures, qualification requirements and procedures, formalities and technical standards pursuant to a measure: (a) that does not conform with Article 128 or 129 and is referred to in points (a) to (c) of Article 133(1) or with Article 135, 136 or 137 and is referred to in points (a) to (c) of Article 139(1) or with points (b) and (c) of Article 141(1), or Article 142(3) or with points (b) and (c) of Article 143(1) and is referred to in Article 144; or (b) referred to in Article 133(2) or Article 139(2). 3. For the purposes of this Section, the following definitions apply: (a) \"authorisation\" means the permission to carry out any of the activities referred to in points (a) to (c) of paragraph 1 resulting from a procedure a natural or legal person must adhere to in order to demonstrate compliance with licensing requirements, qualification requirements, technical standards or formalities for the purposes of obtaining, maintaining or renewing that permission; and (b) \"competent authority\" means a central, regional or local government or authority or non-governmental body in the exercise of powers delegated by central, regional or local governments or authorities, which is entitled to take a decision concerning the authorisation referred to in point (a). Article 147 Submission of applications Each Party shall, to the extent practicable, avoid requiring an applicant to approach more than one competent authority for each application for authorisation. If an activity for which authorisation is requested is within the jurisdiction of multiple competent authorities, multiple applications for authorisation may be required. Article 148 Application timeframes If a Party requires authorisation, it shall ensure that its competent authorities, to the extent practicable, permit the submission of an application at any time throughout the year. If a specific time period for applying for authorisation exists, the Party shall ensure that the competent authorities allow a reasonable period of time for the submission of an application. Article 149 Electronic applications and acceptance of copies If a Party requires authorisation, it shall ensure that its competent authorities: (a) to the extent possible provide for applications to be completed by electronic means, including from within the territory of the other Party; and (b) accept copies of documents, that are authenticated in accordance with the Party's domestic law, in place of original documents, unless the competent authorities require original documents to protect the integrity of the authorisation process. Article 150 Processing of applications 1. If a Party requires authorisation, it shall ensure that its competent authorities: (a) process applications throughout the year. Where that is not possible, this information should be made public in advance, to the extent practicable; (b) to the extent practicable, provide an indicative timeframe for the processing of an application. That timeframe shall be reasonable to the extent practicable; (c) at the request of the applicant, provide without undue delay information concerning the status of the application; (d) to the extent practicable, ascertain without undue delay the completeness of an application for processing under the Party's domestic laws and regulations; (e) if they consider an application complete for the purposes of processing under the Party's domestic laws and regulations, (19) within a reasonable period of time after the submission of the application ensure that: (i) the processing of the application is completed; and (ii) the applicant is informed of the decision concerning the application, to the extent possible, in writing; (20) (f) if they consider an application incomplete for the purposes of processing under the Party's domestic laws and regulations, within a reasonable period of time, to the extent practicable: (i) inform the applicant that the application is incomplete; (ii) at the request of the applicant identify the additional information required to complete the application or otherwise provide guidance on why the application is considered incomplete; and (iii) provide the applicant with the opportunity to provide the additional information that is required to complete the application; (21) however, if none of the actions referred to in points (i), (ii) and (iii) is practicable, and the application is rejected due to incompleteness, the competent authorities shall ensure that they inform the applicant within a reasonable period of time; and (g) if an application is rejected, either upon their own initiative or upon request of the applicant, inform the applicant of the reasons for rejection and of the timeframe for an appeal against that decision and, if applicable, the procedures for resubmission of an application; an applicant shall not be prevented from submitting another application solely on the basis of a previously rejected application. 2. The Parties shall ensure that their competent authorities grant an authorisation as soon as it is established, on the basis of an appropriate examination, that the applicant meets the conditions for obtaining it. 3. The Parties shall ensure that, once granted, an authorisation enters into effect without undue delay, subject to the applicable terms and conditions. (22) Article 151 Fees 1. For all economic activities other than financial services, each Party shall ensure that the authorisation fees charged by its competent authorities are reasonable and transparent and do not in themselves restrict the supply of the relevant service or the pursuit of any other economic activity. Having regard to the cost and administrative burden, each Party is encouraged to accept payment of authorisation fees by electronic means. 2. With regard to financial services, each Party shall ensure that its competent authorities, with respect to authorisation fees that they charge, provide applicants with a schedule of fees or information on how fee amounts are determined, and do not use the fees as a means of avoiding the Party's commitments or obligations. 3. Authorisation fees do not include fees for the use of natural resources, payments for auction, tendering or other non-discriminatory means of awarding concessions or mandated contributions to universal service provision. Article 152 Assessment of qualifications If a Party requires an examination to assess the qualifications of an applicant for authorisation, it shall ensure that its competent authorities schedule such an examination at reasonably frequent intervals and provide a reasonable period of time to enable applicants to request to take the examination. To the extent practicable, each Party shall accept requests in electronic format to take such examinations and shall consider the use of electronic means in other aspects of examination processes. Article 153 Publication and information available 1. If a Party requires authorisation, the Party shall promptly publish the information necessary for persons carrying out or seeking to carry out the activities referred to in Article 146(1) for which the authorisation is required to comply with the requirements, formalities, technical standards and procedures for obtaining, maintaining, amending and renewing such authorisation. Such information shall include, to the extent it exists: (a) the licensing and qualification requirements and procedures and formalities; (b) contact information of relevant competent authorities; (c) authorisation fees; (d) applicable technical standards; (e) procedures for appeal or review of decisions concerning applications; (f) procedures for monitoring or enforcing compliance with the terms and conditions of licences or qualifications; (g) opportunities for public involvement, such as through hearings or comments; and (h) indicative timeframes for the processing of an application. For the purposes of this Section, \"publish\" means to include in an official publication, such as an official journal, or on an official website. Parties shall consolidate electronic publications into a single online portal or otherwise ensure that competent authorities make them easily accessible through alternative electronic means. 2. Each Party shall require each of its competent authorities to respond to any request for information or assistance, to the extent practicable. Article 154 Technical standards Each Party shall encourage its competent authorities, when adopting technical standards, to adopt technical standards developed through open and transparent processes, and shall encourage any body, including relevant international organisations, designated to develop technical standards to do so through open and transparent processes. Article 155 Conditions for authorisation 1. Each Party shall ensure that measures relating to authorisation are based on criteria which preclude the competent authorities from exercising their power of assessment in an arbitrary manner and may include, inter alia, competence and the ability to supply a service or any other economic activity, including to do so in compliance with a Party's regulatory requirements such as health and environmental requirements. For the avoidance of doubt, the Parties understand that in reaching decisions a competent authority may balance criteria. 2. The criteria referred to in paragraph 1 shall be: (a) clear and unambiguous; (b) objective and transparent; (c) pre-established; (d) made public in advance; (e) impartial; and (f) easily accessible. 3. If a Party adopts or maintains a measure relating to authorisation, it shall ensure that: (a) the competent authority concerned processes applications, and reaches and administers its decisions, objectively and impartially and in a manner independent of the undue influence of any person carrying out the economic activity for which authorisation is required; and (b) the procedures themselves do not prevent fulfilment of the requirements. Article 156 Limited numbers of licences If the number of licences available for a given activity is limited because of the scarcity of available natural resources or technical capacity, a Party shall apply a selection procedure to potential candidates which provides full guarantees of impartiality, objectivity and transparency, including, in particular, adequate publicity about the launch, conduct and completion of the procedure. In establishing the rules for the selection procedure, a Party may take into account legitimate policy objectives, including considerations of health, safety, the protection of the environment and the preservation of cultural heritage. SECTION 2 PROVISIONS OF GENERAL APPLICATION Article 157 Review procedures for administrative decisions A Party shall maintain judicial, arbitral or administrative tribunals or procedures which provide, on request of an affected investor or service supplier of the other Party, for the prompt review of, and if justified appropriate remedies for, administrative decisions that affect establishment or operation, cross-border trade in services or the supply of a service through the presence of a natural person of a Party in the territory of the other Party. For the purposes of this Section, \"administrative decisions\" means a decision or action with a legal effect that applies to a specific person, good or service in an individual case and covers the failure to take an administrative decision or take such action when that is so required by a Party's law. If such procedures are not independent of the competent authority entrusted with the administrative decision concerned, a Party shall ensure that the procedures in fact provide for an objective and impartial review. Article 158 Professional qualifications 1. Nothing in this Article shall prevent a Party from requiring that natural persons possess the necessary professional qualifications specified in the territory where the activity is performed, for the sector of activity concerned (23). 2. The professional bodies or authorities, which are relevant for the sector of activity concerned in their respective territories, may develop and provide joint recommendations on the recognition of professional qualifications to the Partnership Council. Such joint recommendations shall be supported by an evidence-based assessment of: (a) the economic value of an envisaged arrangement on the recognition of professional qualifications; and (b) the compatibility of the respective regimes, that is, the extent to which the requirements applied by each Party for the authorisation, licensing, operation and certification are compatible. 3. On receipt of a joint recommendation, the Partnership Council shall review its consistency with this Title within a reasonable period of time. The Partnership Council may, following such review, develop and adopt an arrangement on the conditions for the recognition of professional qualifications by decision as an annex to this Agreement, which shall be considered to form an integral part of this Title. (24) 4. An arrangement referred to in paragraph 3 shall provide for the conditions for recognition of professional qualifications acquired in the Union and professional qualifications acquired in the United Kingdom relating to an activity covered by this Title and Title III of this Heading. 5. The Guidelines for arrangements on the recognition of professional qualifications set out in Annex 24 shall be taken into account in the development of the joint recommendations referred to in paragraph 2 of this Article and by the Partnership Council when assessing whether to adopt such an Arrangement, as referred to in paragraph 3 of this Article. SECTION 3 DELIVERY SERVICES Article 159 Scope and definitions 1. This Section applies to measures of a Party affecting the supply of delivery services in addition to Chapters 1, 2, 3 and 4 of this Title, and to Sections 1 and 2 of this Chapter. 2. For the purposes of this Section, the following definitions apply: (a) \"delivery services\" means postal services, courier services, express delivery services or express mail services, which include the following activities: the collection, sorting, transport, and delivery of postal items; (b) \"express delivery services\" means the collection, sorting, transport and delivery of postal items at accelerated speed and reliability and may include value added elements such as collection from point of origin, personal delivery to the addressee, tracing, possibility of changing the destination and addressee in transit or confirmation of receipt; (c) \"express mail services\" means international express delivery services supplied through the EMS Cooperative, which is the voluntary association of designated postal operators under Universal Postal Union (UPU); (d) \"licence\" means an authorisation that a regulatory authority of a Party may require of an individual supplier in order for that supplier to offer postal or courier services; (e) \"postal item\" means an item up to 31.5 kg addressed in the final form in which it is to be carried by any type of supplier of delivery services, whether public or private and may include items such as a letter, parcel, newspaper or catalogue; (f) \"postal monopoly\" means the exclusive right to supply specified delivery services within a Party's territory or a subdivision thereof pursuant to the law of that Party; and (g) \"universal service\" means the permanent supply of a delivery service of specified quality at all points in the territory of a Party or a subdivision thereof at affordable prices for all users. Article 160 Universal service 1. Each Party has the right to define the kind of universal service obligation it wishes to maintain and to decide on its scope and implementation. Any universal service obligation shall be administered in a transparent, non-discriminatory and neutral manner with regard to all suppliers subject to the obligation. 2. If a Party requires inbound express mail services to be supplied on a universal service basis, it shall not accord preferential treatment to those services over other international express delivery services. Article 161 Universal service funding A party shall not impose fees or other charges on the supply of a delivery service that is not a universal service for the purposes of funding the supply of a universal service. This Article does not apply to generally applicable taxation measures or administrative fees. Article 162 Prevention of market distortive practices Each party shall ensure that suppliers of delivery services subject to a universal service obligation or postal monopolies do not engage in market distortive practices such as: (a) using revenues derived from the supply of the service subject to a universal service obligation or from a postal monopoly to cross-subsidise the supply of an express delivery service or any delivery service which is not subject to a universal service obligation; or (b) unjustifiably differentiating between consumers with respect to tariffs or other terms and conditions for the supply of a service subject to a universal service or a postal monopoly. Article 163 Licences 1. If a Party requires a licence for the provision of delivery services, it shall make publicly available: (a) all the licensing requirements and the period of time normally required to reach a decision concerning an application for a licence; and (b) the terms and conditions of licences. 2. The procedures, obligations and requirements of a licence shall be transparent, non-discriminatory and based on objective criteria. 3. If a licence application is rejected by the competent authority, it shall inform the applicant of the reasons for the rejection in writing. Each Party shall establish an appeal procedure through an independent body available to applicants whose licence has been rejected. That body may be a court. Article 164 Independence of the regulatory body 1. Each Party shall establish or maintain a regulatory body which shall be legally distinct from and functionally independent from any supplier of delivery services. If a Party owns or controls a supplier of delivery services, it shall ensure the effective structural separation of the regulatory function from activities associated with ownership or control. 2. The regulatory bodies shall perform their tasks in a transparent and timely manner and have adequate financial and human resources to carry out the task assigned to them. Their decisions shall be impartial with respect to all market participants. SECTION 4 TELECOMMUNICATIONS SERVICES Article 165 Scope This Section applies to measures of a Party affecting the supply of telecommunications services in addition to Chapters 1, 2, 3 and 4 of this Title, and to Sections 1 and 2 of this Chapter. Article 166 Definitions For the purposes of this Section, the following definitions apply: (a) \"associated facilities\" means associated services, physical infrastructure and other facilities or elements associated with a telecommunications network or telecommunications service which enable or support the supply of services via that network or service or have the potential to do so; (b) \"end user\" means a final consumer of, or subscriber to, a public telecommunications service, including a service supplier other than a supplier of public telecommunications services; (c) \"essential facilities\" means facilities of a public telecommunications network or a public telecommunications service that: (i) are exclusively or predominantly provided by a single or limited number of suppliers; and (ii) cannot feasibly be economically or technically substituted in order to provide a service; (d) \"interconnection\" means the linking of public telecommunications networks used by the same or different suppliers of telecommunications networks or telecommunications services in order to allow the users of one supplier to communicate with users of the same or another supplier or to access services provided by another supplier, irrespective of whether those services are provided by the suppliers involved or any other supplier who has access to the network; (e) \"international mobile roaming service\" means a commercial mobile service provided pursuant to a commercial agreement between suppliers of public telecommunications services that enables an end user to use its home mobile handset or other device for voice, data or messaging services while outside the territory in which the end user's home public telecommunications network is located; (f) \"internet access service\" means a public telecommunications service that provides access to the internet and thereby connectivity to virtually all end points of the internet, irrespective of the network technology and terminal equipment used; (g) \"leased circuit\" means telecommunications services or facilities, including those of a virtual nature, that set aside capacity for the dedicated use by, or availability to, a user between two or more designated points; (h) \"major supplier\" means a supplier of telecommunications networks or telecommunications services which has the ability to materially affect the terms of participation, having regard to price and supply, in a relevant market for telecommunications networks or telecommunications services as a result of control over essential facilities or the use of its position in that market; (i) \"network element\" means a facility or equipment used in supplying a telecommunications service, including features, functions and capabilities provided by means of that facility or equipment; (j) \"number portability\" means the ability of subscribers who so request to retain the same telephone numbers, at the same location in the case of a fixed line, without impairment of quality, reliability or convenience when switching between the same category of suppliers of public telecommunications services; (k) \"public telecommunications network\" means any telecommunications network used wholly or mainly for the provision of public telecommunications services which supports the transfer of information between network termination points; (l) \"public telecommunications service\" means any telecommunications service that is offered to the public generally; (m) \"subscriber\" means any natural or legal person which is party to a contract with a supplier of public telecommunications services for the supply of such services; (n) \"telecommunications\" means the transmission and reception of signals by any electromagnetic means; (o) \"telecommunications network\" means transmission systems and, where applicable, switching or routing equipment and other resources, including network elements which are not active, which permit the transmission and reception of signals by wire, radio, optical, or other electromagnetic means; (p) \"telecommunications regulatory authority\" means the body or bodies charged by a Party with the regulation of telecommunications networks and telecommunications services covered by this Section; (q) \"telecommunications service\" means a service which consists wholly or mainly in the transmission and reception of signals, including broadcasting signals, over telecommunications networks, including those used for broadcasting, but not a service providing, or exercising editorial control over, content transmitted using telecommunications networks and telecommunications services; (r) \"universal service\" means the minimum set of services of specified quality that must be made available to all users, or to a set of users, in the territory of a Party, or in a subdivision thereof, regardless of their geographical location and at an affordable price; and (s) \"user\" means any natural or legal person using a public telecommunications service. Article 167 Telecommunications regulatory authority 1. Each Party shall establish or maintain a telecommunications regulatory authority that: (a) is legally distinct and functionally independent from any supplier of telecommunications networks, telecommunications services or telecommunications equipment; (b) uses procedures and issues decisions that are impartial with respect to all market participants; (c) acts independently and does not seek or take instructions from any other body in relation to the exercise of the tasks assigned to it by law to enforce the obligations set out in Articles 169, 170, 171, 173 and 174; (d) has the regulatory power, as well as adequate financial and human resources, to carry out the tasks mentioned in point (c) of this Article; (e) has the power to ensure that suppliers of telecommunications networks or telecommunications services provide it, promptly upon request, with all the information (25), including financial information, which is necessary to enable it to carry out the tasks mentioned in point (c) of this Article; and (f) exercises its powers transparently and in a timely manner. 2. Each Party shall ensure that the tasks assigned to the telecommunications regulatory authority are made public in an easily accessible and clear form, in particular where those tasks are assigned to more than one body. 3. A Party that retains ownership or control of suppliers of telecommunications networks or telecommunications services shall ensure the effective structural separation of the regulatory function from activities associated with ownership or control. 4. Each Party shall ensure that a user or supplier of telecommunications networks or telecommunications services affected by a decision of the telecommunications regulatory authority has a right of appeal before an appeal body which is independent of the regulatory authority and other affected parties. Pending the outcome of the appeal, the decision shall stand, unless interim measures are granted in accordance with the Party's law. Article 168 Authorisation to provide telecommunications networks or services 1. Each Party shall permit the provision of telecommunications networks or telecommunications services without a prior formal authorisation. 2. Each Party shall make publicly available all the criteria, applicable procedures and terms and conditions under which suppliers are permitted to provide telecommunications networks or telecommunications services. 3. Any authorisation criteria and applicable procedures shall be as simple as possible, objective, transparent, non-discriminatory and proportionate. Any obligations and conditions imposed on or associated with an authorisation shall be non-discriminatory, transparent and proportionate, and shall be related to the services or networks provided. 4. Each Party shall ensure that an applicant for an authorisation receives in writing the reasons for any denial or revocation of an authorisation or the imposition of supplier-specific conditions. In such cases, the applicant shall have a right of appeal before an appeal body. 5. Administrative fees imposed on suppliers shall be objective, transparent, non-discriminatory and commensurate with the administrative costs reasonably incurred in the management, control and enforcement of the obligations set out in this Section (26). Article 169 Interconnection Each Party shall ensure that a supplier of public telecommunications networks or public telecommunications services has the right and, when so requested by another supplier of public telecommunications networks or public telecommunications services, the obligation to negotiate interconnection for the purposes of providing public telecommunications networks or public telecommunications services. Article 170 Access and use 1. Each Party shall ensure that any covered enterprise or service supplier of the other Party is accorded access to and use of public telecommunications networks or public telecommunications services on reasonable and non-discriminatory (27) terms and conditions. This obligation shall be applied, inter alia, to paragraphs 2 to 5. 2. Each Party shall ensure that covered enterprises or service suppliers of the other Party have access to and use of any public telecommunications network or public telecommunications service offered within or across its border, including private leased circuits, and to that end shall ensure, subject to paragraph 5, that such enterprises and suppliers are permitted: (a) to purchase or lease and attach terminal or other equipment which interfaces with the network and which is necessary to conduct their operations; (b) to interconnect private leased or owned circuits with public telecommunications networks or with circuits leased or owned by another covered enterprise or service supplier; and (c) to use the operating protocols of their choice in their operations, other than as necessary to ensure the availability of telecommunications services to the public generally. 3. Each Party shall ensure that covered enterprises or service suppliers of the other Party may use public telecommunications networks and public telecommunications services for the movement of information within and across borders, including for their intra-corporate communications, and for access to information contained in databases or otherwise stored in machine-readable form in the territory of either Party. 4. Notwithstanding paragraph 3, a Party may take such measures as are necessary to ensure the security and confidentiality of communications, subject to the requirement that such measures are not applied in a manner which would constitute either a disguised restriction on trade in services or a means of arbitrary or unjustifiable discrimination or of nullification or impairment of benefits under this Title. 5. Each Party shall ensure that no condition is imposed on access to and use of public telecommunications networks or services other than as necessary: (a) to safeguard the public service responsibilities of suppliers of public telecommunications networks or public telecommunications services, in particular their ability to make their services available to the public generally; or (b) to protect the technical integrity of public telecommunications networks or services. Article 171 Resolution of telecommunications disputes 1. Each Party shall ensure that, in the event of a dispute arising between suppliers of telecommunications networks or telecommunications services in connection with rights and obligations that arise from this Section, and upon request of either party involved in the dispute, the telecommunications regulatory authority issues a binding decision within a reasonable timeframe to resolve the dispute. 2. The decision by the telecommunications regulatory authority shall be made available to the public, having regard to the requirements of business confidentiality. The parties concerned shall be given a full statement of the reasons on which it is based and shall have the right of appeal referred to in Article 167(4). 3. The procedure referred to in paragraphs 1 and 2 shall not preclude either party concerned from bringing an action before a judicial authority. Article 172 Competitive safeguards on major suppliers Each Party shall introduce or maintain appropriate measures for the purpose of preventing suppliers of telecommunications networks or telecommunications services who, alone or together, are a major supplier from engaging in or continuing anti-competitive practices. These anti-competitive practices shall include in particular: (a) engaging in anti-competitive cross-subsidisation; (b) using information obtained from competitors with anti-competitive results; and (c) not making available to other service suppliers on a timely basis technical information about essential facilities and commercially relevant information which are necessary for them to provide services. Article 173 Interconnection with major suppliers 1. Each Party shall ensure that major suppliers of public telecommunications networks or public telecommunications services provide interconnection at any technically feasible point in the network. Such interconnection shall be provided: (a) under non-discriminatory terms and conditions (including as regards rates, technical standards, specifications, quality and maintenance) and of a quality no less favourable than that provided for the own like services of such major supplier, or for like services of its subsidiaries or other affiliates; (b) in a timely fashion, on terms and conditions (including as regards rates, technical standards, specifications, quality and maintenance) that are transparent, reasonable, having regard to economic feasibility, and sufficiently unbundled so that the supplier need not pay for network elements or facilities that it does not require for the service to be provided; and (c) upon request, at points in addition to the network termination points offered to the majority of users, subject to charges that reflect the cost of construction of necessary additional facilities. 2. The procedures applicable for interconnection to a major supplier shall be made publicly available. 3. Major suppliers shall make publicly available either their interconnection agreements or their reference interconnection offers as appropriate. Article 174 Access to major suppliers' essential facilities Each Party shall ensure that major suppliers in its territory make their essential facilities available to suppliers of telecommunications networks or telecommunications services on reasonable, transparent and non-discriminatory terms and conditions for the purpose of providing public telecommunications services, except where this is not necessary to achieve effective competition on the basis of the facts collected and the assessment of the market conducted by the telecommunications regulatory authority. The major supplier's essential facilities may include network elements, leased circuits services and associated facilities. Article 175 Scarce resources 1. Each Party shall ensure that the allocation and granting of rights of use of scarce resources, including radio spectrum, numbers and rights of way, is carried out in an open, objective, timely, transparent, non-discriminatory and proportionate manner and by taking into account general interest objectives. Procedures, and conditions and obligations attached to rights of use, shall be based on objective, transparent, non-discriminatory and proportionate criteria. 2. The current use of allocated frequency bands shall be made publicly available, but detailed identification of radio spectrum allocated for specific government uses is not required. 3. Parties may rely on market-based approaches, such as bidding procedures, to assign spectrum for commercial use. 4. The Parties understand that measures of a Party allocating and assigning spectrum and managing frequency are not in and of themselves inconsistent with Articles 128 and 135. Each Party retains the right to establish and apply spectrum and frequency management measures that may have the effect of limiting the number of suppliers of telecommunications services, provided that it does so in a manner consistent with this Agreement. This includes the ability to allocate frequency bands taking into account current and future needs and spectrum availability. Article 176 Universal service 1. Each Party has the right to define the kind of universal service obligations it wishes to maintain and to decide on their scope and implementation. 2. Each Party shall administer the universal service obligations in a proportionate, transparent, objective and non-discriminatory way, which is neutral with respect to competition and not more burdensome than necessary for the kind of universal service defined by the Party. 3. Each Party shall ensure that procedures for the designation of universal service suppliers are open to all suppliers of public telecommunications networks or public telecommunications services. Such designation shall be made through an efficient, transparent and non-discriminatory mechanism. 4. If a Party decides to compensate the universal service suppliers, it shall ensure that such compensation does not exceed the net cost caused by the universal service obligation. Article 177 Number portability Each Party shall ensure that suppliers of public telecommunications services provide number portability on reasonable terms and conditions. Article 178 Open internet access 1. Each Party shall ensure that, subject to its laws and regulations, suppliers of internet access services enable users of those services to: (a) access and distribute information and content, use and provide applications and services of their choice, subject to non-discriminatory, reasonable, transparent and proportionate network management; and (b) use devices of their choice, provided that such devices do not harm the security of other devices, the network or services provided over the network. 2. For greater certainty, nothing in this Article shall prevent the Parties from adopting measures with the aim of protecting public safety with regards to users online. Article 179 Confidentiality of information 1. Each Party shall ensure that suppliers that acquire information from another supplier in the process of negotiating arrangements pursuant to Articles 169, 170, 173 and 174 use that information solely for the purpose for which it was supplied and respect at all times the confidentiality of information transmitted or stored. 2. Each Party shall ensure the confidentiality of communications and related traffic data transmitted in the use of public telecommunications networks or public telecommunications services subject to the requirement that measures applied to that end do not constitute a means of arbitrary or unjustifiable discrimination or a disguised restriction on trade in services. Article 180 Foreign shareholding With regard to the provision of telecommunications networks or telecommunications services through establishment and notwithstanding Article 133, a Party shall not impose joint venture requirements or limit the participation of foreign capital in terms of maximum percentage limits on foreign shareholding or the total value of individual or aggregate foreign investment. Article 181 International mobile roaming (28) 1. The Parties shall endeavour to cooperate on promoting transparent and reasonable rates for international mobile roaming services in ways that can help promote the growth of trade among the Parties and enhance consumer welfare. 2. Parties may choose to take steps to enhance transparency and competition with respect to international mobile roaming rates and technological alternatives to roaming services, such as: (a) ensuring that information regarding retail rates is easily accessible to end users; and (b) minimising impediments to the use of technological alternatives to roaming, whereby end users visiting the territory of a Party from the territory of the other Party can access telecommunications services using the device of their choice. 3. Each Party shall encourage suppliers of public telecommunications services in its territory to make publicly available information on retail rates for international mobile roaming services for voice, data and text messages offered to their end users when visiting the territory of the other Party. 4. Nothing in this Article shall require a Party to regulate rates or conditions for international mobile roaming services. SECTION 5 FINANCIAL SERVICES Article 182 Scope 1. This Section applies to measures of a Party affecting the supply of financial services in addition to Chapters 1, 2, 3 and 4 of this Title, and to Sections 1 and 2 of this Chapter. 2. For the purposes of this Section, the term \"activities performed in the exercise of governmental authority\" referred to in point (f) of Article 124 means the following (29): (a) activities conducted by a central bank or a monetary authority or by any other public entity in pursuit of monetary or exchange rate policies; (b) activities forming part of a statutory system of social security or public retirement plans; and (c) other activities conducted by a public entity for the account or with the guarantee or using the financial resources of the Party or its public entities. 3. For the purposes of the application of point (f) of Article 124 to this Section, if a Party allows any of the activities referred to in point (b) or (c) of paragraph 2 of this Article to be conducted by its financial service suppliers in competition with a public entity or a financial service supplier, \"activities performed in the exercise of governmental authority\" does not include those activities. 4. Point (a) of Article 124 does not apply to services covered by this Section. Article 183 Definitions For the purposes of this Title, the following definitions apply: (a) \"financial service\" means any service of a financial nature offered by a financial service supplier of a Party and includes the following activities: (i) insurance and insurance-related services: (A) direct insurance (including co-insurance): (aa) life; (bb) non-life; (B) reinsurance and retrocession; (C) insurance intermediation, such as brokerage and agency; and (D) services auxiliary to insurance, such as consultancy, actuarial, risk assessment and claim settlement services; (ii) banking and other financial services (excluding insurance): (A) acceptance of deposits and other repayable funds from the public; (B) lending of all types, including consumer credit, mortgage credit, factoring and financing of commercial transaction; (C) financial leasing; (D) all payment and money transmission services, including credit, charge and debit cards, travellers cheques and bankers drafts; (E) guarantees and commitments; (F) trading for own account or for account of customers, whether on an exchange, in an over-the-counter market or otherwise, the following: (aa) money market instruments (including cheques, bills, certificates of deposits); (bb) foreign exchange; (cc) derivative products including, but not limited to, futures and options; (dd) exchange rate and interest rate instruments, including products such as swaps, forward rate agreements; (ee) transferable securities; and (ff) other negotiable instruments and financial assets, including bullion; (G) participation in issues of all kinds of securities, including underwriting and placement as agent (whether publicly or privately) and provision of services related to such issues; (H) money broking; (I) asset management, such as cash or portfolio management, all forms of collective investment management, pension fund management, custodial, depository and trust services; (J) settlement and clearing services for financial assets, including securities, derivative products, and other negotiable instruments; (K) provision and transfer of financial information, and financial data processing and related software; and (L) advisory, intermediation and other auxiliary financial services on all the activities listed in points (A) to (K), including credit reference and analysis, investment and portfolio research and advice, advice on acquisitions and on corporate restructuring and strategy; (b) \"financial service supplier\" means any natural or legal person of a Party that seeks to supply or supplies financial services and does not include a public entity; (c) \"new financial service\" means a service of a financial nature including services related to existing and new products or the manner in which a product is delivered, that is not supplied by any financial service supplier in the territory of a Party but which is supplied in the territory of the other Party; (d) \"public entity\" means: (i) a government, a central bank or a monetary authority, of a Party, or an entity owned or controlled by a Party, that is principally engaged in carrying out governmental functions or activities for governmental purposes, not including an entity principally engaged in supplying financial services on commercial terms; or (ii) a private entity, performing functions normally performed by a central bank or monetary authority, when exercising those functions; (e) \"self-regulatory organisation\" means any non-governmental body, including a securities or futures exchange or market, clearing agency, other organisation or association, that exercises regulatory or supervisory authority over financial service suppliers by statute or delegation from central, regional or local governments or authorities, where applicable. Article 184 Prudential carve-out 1. Nothing in this Agreement shall prevent a Party from adopting or maintaining measures for prudential reasons (30), such as: (a) the protection of investors, depositors, policy-holders or persons to whom a fiduciary duty is owed by a financial service supplier; or (b) ensuring the integrity and stability of a Party's financial system. 2. Where such measures do not conform with the provisions of this Agreement, they shall not be used as a means of avoiding the Party's commitments or obligations under this Agreement. Article 185 Confidential information Without prejudice to Part Three, nothing in this Agreement shall be construed to require a Party to disclose information relating to the affairs and accounts of individual consumers or any confidential or proprietary information in the possession of public entities. Article 186 International standards The Parties shall make their best endeavours to ensure that internationally agreed standards in the financial services sector for regulation and supervision, for the fight against money laundering and terrorist financing and for the fight against tax evasion and avoidance, are implemented and applied in their territory. Such internationally agreed standards are, inter alia, those adopted by: the G20; the Financial Stability Board; the Basel Committee on Banking Supervision, in particular its \"Core Principle for Effective Banking Supervision\"; the International Association of Insurance Supervisors, in particular its \"Insurance Core Principles\"; the International Organisation of Securities Commissions, in particular its \"Objectives and Principles of Securities Regulation\"; the Financial Action Task Force; and the Global Forum on Transparency and Exchange of Information for Tax Purposes of the Organisation for Economic Cooperation and Development. Article 187 Financial services new to the territory of a Party 1. Each Party shall permit a financial service supplier of the other Party established in its territory to supply any new financial service that it would permit its own financial service suppliers to supply in accordance with its law in like situations, provided that the introduction of the new financial service does not require the adoption of a new law or the amendment of an existing law. This does not apply to branches of the other Party established in the territory of a Party. 2. A Party may determine the institutional and legal form through which the service may be supplied and require authorisation for the supply of the service. Where such authorisation is required, a decision shall be made within a reasonable time and the authorisation may only be refused for prudential reasons. Article 188 Self-regulatory organisations Where a Party requires membership of, participation in, or access to, any self-regulatory organisation in order for financial service suppliers of the other Party to supply financial services in its territory, the Party shall ensure observance by that self-regulatory organisation of the obligations under Articles 129, 130, 137 and 138. Article 189 Clearing and payment systems Under terms and conditions that accord national treatment, each Party shall grant to financial service suppliers of the other Party established in its territory access to payment and clearing systems operated by public entities, and to official funding and refinancing facilities available in the normal course of ordinary business. This Article does not confer access to the Party's lender of last resort facilities. SECTION 6 INTERNATIONAL MARITIME TRANSPORT SERVICES Article 190 Scope and definitions 1. This Section applies to measures of a Party affecting the supply of international maritime transport services in addition to Chapters 1, 2, 3, 4 and Section 1 of this Chapter. 2. For the purposes of this Section and Chapters 1, 2, 3 and 4 of this Title, the following definitions apply: (a) \"international maritime transport services\" means the transport of passengers or cargo by sea-going vessels between a port of one Party and a port of the other Party or of a third country, or between ports of different Member States, including the direct contracting with providers of other transport services, with a view to covering door-to-door or multimodal transport operations under a single transport document, but does not include the right to provide such other transport services; (b) \"door-to-door or multimodal transport operations\" means the transport of international cargo using more than one mode of transport, that includes an international sea-leg, under a single transport document; (c) \"international cargo\" means cargo transported between a port of one Party and a port of the other Party or of a third country, or between ports of different Member States; (d) \"maritime auxiliary services\" means maritime cargo handling services, customs clearance services, container station and depot services, maritime agency services, maritime freight forwarding services and storage and warehousing services; (e) \"maritime cargo handling services\" means activities exercised by stevedore companies, including terminal operators but not including the direct activities of dockers if the workforce is organised independently of the stevedoring or terminal operator companies; the activities covered include the organisation and supervision of: (i) loading or discharging of cargo to or from a ship; (ii) the lashing or unlashing of cargo; and (iii) the reception or delivery and safekeeping of cargoes before shipment or after discharge; (f) \"customs clearance services\" means activities consisting in carrying out, on behalf of another party, customs formalities concerning import, export or through transport of cargoes, irrespective of whether these services are the main activity of the service supplier or a usual complement of its main activity; (g) \"container station and depot services\" means activities that consist of storing, stuffing, stripping or repairing of containers and making containers available for shipment, whether in port areas or inland; (h) \"maritime agency services\" means activities that consist of representing, within a given geographic area, as an agent the business interests of one or more shipping lines or shipping companies, for the following purposes: (i) marketing and sales of maritime transport and related services, from quotation to invoicing, issuance of bills of lading on behalf of the lines or companies, acquisition and resale of the necessary related services, preparation of documentation and provision of business information; and (ii) acting on behalf of the lines or companies organising the call of the ship or taking over cargoes when required; (i) \"feeder services\" means, without prejudice to the scope of activities that may be considered cabotage under the relevant national legislation, the pre- and onward transportation by sea of international cargo, including containerised, break bulk and dry or liquid bulk cargo, between ports located in the territory of a Party, provided such international cargo is \"en route\", that is, directed to a destination, or coming from a port of shipment, outside the territory of that Party; (j) \"maritime freight forwarding services\" means the activity consisting of organising and monitoring shipment operations on behalf of shippers, through the arrangement of transport and related services, preparation of documentation and provision of business information; (k) \"port services\" means services provided inside a maritime port area or on the waterway access to such area by the managing body of a port, its subcontractors, or other service providers to support the transport of cargo or passengers; and (l) \"storage and warehousing services\" means storage services of frozen or refrigerated goods, bulk storage services of liquids or gases, and other storage or warehousing services. Article 191 Obligations 1. Without prejudice to non-conforming measures or other measures referred to in Articles 133 and 139, each Party shall implement the principle of unrestricted access to the international maritime markets and trades on a commercial and non-discriminatory basis by: (a) according to ships flying the flag of the other Party, or operated by service suppliers of the other Party, treatment no less favourable than that accorded to its own ships with regard to, inter alia: (i) access to ports; (ii) the use of port infrastructure; (iii) the use of maritime auxiliary services; and (iv) customs facilities and the assignment of berths and facilities for loading and unloading, including related fees and charges; (b) making available to international maritime transport service suppliers of the other Party, on terms and conditions which are both reasonable and no less favourable than those applicable to its own suppliers or vessels or to vessels or suppliers of a third country (including fees and charges, specifications and quality of the service to be provided), the following port services: pilotage, towing and tug assistance, provisioning, fuelling and watering, garbage collecting and ballast waste disposal, port captain's services, navigation aids, emergency repair facilities, anchorage, berth, berthing and unberthing services and shore-based operational services essential to ship operations, including communications, water and electrical supplies; (c) permitting international maritime transport service suppliers of the other Party, subject to the authorisation by the competent authority where applicable, to re-position owned or leased empty containers, which are not being carried as cargo against payment, between ports of the United Kingdom or between ports of a Member State; and (d) permitting international maritime transport service suppliers of the other Party to provide feeder services between ports of the United Kingdom or between ports of a Member State, subject to the authorisation by the competent authority where applicable. 2. In applying the principle referred to in paragraph 1, a Party shall: (a) not introduce cargo-sharing arrangements in future agreements with third countries concerning international maritime transport services, including dry and liquid bulk and liner trade, and terminate, within a reasonable period of time, such cargo-sharing arrangements in case they exist in previous agreements; (b) not adopt or maintain a measure that requires all or part of any international cargo to be transported exclusively by vessels registered in that Party or owned or controlled by natural persons of that Party; (c) abolish and abstain from introducing any unilateral measures or administrative, technical and other obstacles which could constitute a disguised restriction or have discriminatory effects on the free supply of international maritime transport services; and (d) not prevent international maritime transport service suppliers of the other Party from directly contracting with other transport service suppliers for door-to-door or multimodal transport operations. SECTION 7 LEGAL SERVICES Article 192 Scope 1. This Section applies to measures of a Party affecting the supply of designated legal services in addition to Chapters 1, 2, 3 and 4 of this Title and to Sections 1 and 2 of this Chapter. 2. Nothing in this Section shall affect the right of a Party to regulate and supervise the supply of designated legal services in its territory in a non-discriminatory manner. Article 193 Definitions For the purposes of this Section, the following definitions apply: (a) \"designated legal services\" means legal services in relation to home jurisdiction law and public international law, excluding Union law; (b) \"home jurisdiction\" means the jurisdiction (or a part of the jurisdiction) of the Member State or of the United Kingdom in which a lawyer acquired their home jurisdiction professional title or, in the case of a lawyer who has acquired a home jurisdiction professional title in more than one jurisdiction, any of those jurisdictions; (c) \"home jurisdiction law\" means the law of the lawyer's home jurisdiction (31); (d) \"home jurisdiction professional title\" means: (i) for a lawyer of the Union, a professional title acquired in a Member State authorising the supply of legal services in that Member State; or (ii) for a lawyer of the United Kingdom, the title of advocate, barrister or solicitor, authorising the supply of legal services in any part of the jurisdiction of the United Kingdom; (e) \"lawyer\" means: (i) a natural person of the Union who is authorised in a Member State to supply legal services under a home jurisdiction professional title; or (ii) a natural person of the United Kingdom who is authorised in any part of the jurisdiction of the United Kingdom to supply legal services under a home jurisdiction professional title; (f) \"lawyer of the other Party\" means: (i) where \"the other Party\" is the Union, a lawyer referred to in point (e)(i); or (ii) where \"the other Party\" is the United Kingdom, a lawyer referred to in point (e)(ii); and (g) \"legal services\" means the following services: (i) legal advisory services; and (ii) legal arbitration, conciliation and mediation services (but excluding such services when supplied by natural persons as set out in Article 140). (32) \"Legal services\" do not include legal representation before administrative agencies, the courts, and other duly constituted official tribunals of a Party, legal advisory and legal authorisation, documentation and certification services supplied by legal professionals entrusted with public functions in the administration of justice such as notaries, \"huissiers de justice\" or other \"officiers publics et minist\u00e9riels\", and services supplied by bailiffs who are appointed by an official act of government. Article 194 Obligations 1. A Party shall allow a lawyer of the other Party to supply in its territory designated legal services under that lawyer's home jurisdiction professional title in accordance with Articles 128, 129, 135, 137 and 143. 2. Where a Party (the \"host jurisdiction\") requires registration in its territory as a condition for a lawyer of the other Party to supply designated legal services pursuant to paragraph 1, the requirements and process for such registration shall not: (a) be less favourable than those which apply to a natural person of a third country who is supplying legal services in relation to third country law or public international law under that person's third country professional title in the territory of the host jurisdiction; and (b) amount to or be equivalent to any requirement to requalify into or be admitted to the legal profession of the host jurisdiction. 3. Paragraph 4 applies to the supply of designated legal services pursuant to paragraph 1 through establishment. 4. A Party shall allow a legal person of the other Party to establish a branch in its territory through which designated legal services (33) are supplied pursuant to paragraph 1, in accordance with and subject to the conditions set out in Chapter 2 of this Title. This shall be without prejudice to requirements that a certain percentage of the shareholders, owners, partners, or directors of a legal person be qualified or practice a certain profession such as lawyers or accountants. Article 195 Non-conforming measures 1. Article 194 does not apply to: (a) any existing non-conforming measure of a Party at the level of: (i) for the Union: (A) the Union, as set out in the Schedule of the Union in Annex 19; (B) the central government of a Member State, as set out in the Schedule of the Union in Annex 19; (C) a regional government of a Member State, as set out in the Schedule of the Union in Annex 19; or (D) a local government, other than that referred to in point (C); and (ii) for the United Kingdom: (A) the central government, as set out in the Schedule of the United Kingdom in Annex 19; (B) a regional government, as set out in the Schedule of the United Kingdom in Annex 19; or (C) a local government; (b) the continuation or prompt renewal of any non-conforming measure referred to in point (a) of this paragraph; or (c) a modification to any non-conforming measure referred to in points (a) and (b) of this paragraph to the extent that it does not decrease the conformity of the measure, as it existed immediately before the modification, with Article 194. 2. Article 194 does not apply to any measure of a Party which is consistent with the reservations, conditions or qualifications specified with respect to a sector, subsector or activity listed in Annex 20. 3. This Section applies without prejudice to Annex 22. TITLE III DIGITAL TRADE CHAPTER 1 GENERAL PROVISIONS Article 196 Objective The objective of this Title is to facilitate digital trade, to address unjustified barriers to trade enabled by electronic means and to ensure an open, secure and trustworthy online environment for businesses and consumers. Article 197 Scope 1. This Title applies to measures of a Party affecting trade enabled by electronic means. 2. This Title does not apply to audio-visual services. Article 198 Right to regulate The Parties reaffirm the right to regulate within their territories to achieve legitimate policy objectives, such as the protection of public health, social services, public education, safety, the environment including climate change, public morals, social or consumer protection, privacy and data protection, or the promotion and protection of cultural diversity. Article 199 Exceptions For greater certainty, nothing in this Title prevents the Parties from adopting or maintaining measures in accordance with Articles 184, 412 and 415 for the public interest reasons set out therein. Article 200 Definitions 1. The definitions in Article 124 apply to this Title. 2. For the purposes of this Title, the following definitions apply: (a) \"consumer\" means any natural person using a public telecommunications service for other than professional purposes; (b) \"direct marketing communication\" means any form of commercial advertising by which a natural or legal person communicates marketing messages directly to a user via a public telecommunications service and covers at least electronic mail and text and multimedia messages (SMS and MMS); (c) \"electronic authentication\" means an electronic process that enables the confirmation of: (i) the electronic identification of a natural or legal person, or (ii) the origin and integrity of data in electronic form; (d) \"electronic registered delivery service\" means a service that makes it possible to transmit data between third parties by electronic means and provides evidence relating to the handling of the transmitted data, including proof of sending and receiving the data, and that protects transmitted data against the risk of loss, theft, damage or any unauthorised alterations; (e) \"electronic seal\" means data in electronic form used by a legal person which is attached to or logically associated with other data in electronic form to ensure the latter's origin and integrity; (f) \"electronic signature\" means data in electronic form which is attached to or logically associated with other data in electronic form that: (i) is used by a natural person to agree on the data in electronic form to which it relates; and (ii) is linked to the data in electronic form to which it relates in such a way that any subsequent alteration in the data is detectable; (g) \"electronic time stamp\" means data in electronic form which binds other data in electronic form to a particular time establishing evidence that the latter data existed at that time; (h) \"electronic trust service\" means an electronic service consisting of: (i) the creation, verification and validation of electronic signatures, electronic seals, electronic time stamps, electronic registered delivery services and certificates related to those services; (ii) the creation, verification and validation of certificates for website authentication; or (iii) the preservation of electronic signatures, seals or certificates related to those services; (i) \"government data\" means data owned or held by any level of government and by non-governmental bodies in the exercise of powers conferred on them by any level of government; (j) \"public telecommunications service\" means any telecommunications service that is offered to the public generally; (k) \"user\" means any natural or legal person using a public telecommunications service. CHAPTER 2 DATA FLOWS AND PERSONAL DATA PROTECTION Article 201 Cross-border data flows 1. The Parties are committed to ensuring cross-border data flows to facilitate trade in the digital economy. To that end, cross-border data flows shall not be restricted between the Parties by a Party: (a) requiring the use of computing facilities or network elements in the Party's territory for processing, including by imposing the use of computing facilities or network elements that are certified or approved in the territory of a Party; (b) requiring the localisation of data in the Party's territory for storage or processing; (c) prohibiting the storage or processing in the territory of the other Party; or (d) making the cross-border transfer of data contingent upon use of computing facilities or network elements in the Parties' territory or upon localisation requirements in the Parties' territory. 2. The Parties shall keep the implementation of this provision under review and assess its functioning within three years of the date of entry into force of this Agreement. A Party may at any time propose to the other Party to review the list of restrictions listed in paragraph 1. Such a request shall be accorded sympathetic consideration. Article 202 Protection of personal data and privacy 1. Each Party recognises that individuals have a right to the protection of personal data and privacy and that high standards in this regard contribute to trust in the digital economy and to the development of trade. 2. Nothing in this Agreement shall prevent a Party from adopting or maintaining measures on the protection of personal data and privacy, including with respect to cross-border data transfers, provided that the law of the Party provides for instruments enabling transfers under conditions of general application (34) for the protection of the data transferred. 3. Each Party shall inform the other Party about any measure referred to in paragraph 2 that it adopts or maintains. CHAPTER 3 SPECIFIC PROVISIONS Article 203 Customs duties on electronic transmissions 1. Electronic transmissions shall be considered as the supply of a service within the meaning of Title II of this Heading. 2. The Parties shall not impose customs duties on electronic transmissions. Article 204 No prior authorisation 1. A Party shall not require prior authorisation of the provision of a service by electronic means solely on the ground that the service is provided online, and shall not adopt or maintain any other requirement having an equivalent effect. A service is provided online when it is provided by electronic means and without the parties being simultaneously present. 2. Paragraph 1 does not apply to telecommunications services, broadcasting services, gambling services, legal representation services or to the services of notaries or equivalent professions to the extent that they involve a direct and specific connection with the exercise of public authority. Article 205 Conclusion of contracts by electronic means 1. Each Party shall ensure that contracts may be concluded by electronic means and that its law neither creates obstacles for the use of electronic contracts nor results in contracts being deprived of legal effect and validity solely on the ground that the contract has been made by electronic means. 2. Paragraph 1 does not apply to the following: (a) broadcasting services; (b) gambling services; (c) legal representation services; (d) the services of notaries or equivalent professions involving a direct and specific connection with the exercise of public authority; (e) contracts that require witnessing in person; (f) contracts that establish or transfer rights in real estate; (g) contracts requiring by law the involvement of courts, public authorities or professions exercising public authority; (h) contracts of suretyship granted, collateral securities furnished by persons acting for purposes outside their trade, business or profession; or (i) contracts governed by family law or by the law of succession. Article 206 Electronic authentication and electronic trust services 1. A Party shall not deny the legal effect and admissibility as evidence in legal proceedings of an electronic document, an electronic signature, an electronic seal or an electronic time stamp, or of data sent and received using an electronic registered delivery service, solely on the ground that it is in electronic form. 2. A Party shall not adopt or maintain measures that would: (a) prohibit parties to an electronic transaction from mutually determining the appropriate electronic authentication methods for their transaction; or (b) prevent parties to an electronic transaction from being able to prove to judicial and administrative authorities that the use of electronic authentication or an electronic trust service in that transaction complies with the applicable legal requirements. 3. Notwithstanding paragraph 2, a Party may require that for a particular category of transactions, the method of electronic authentication or trust service is certified by an authority accredited in accordance with its law or meets certain performance standards which shall be objective, transparent and non-discriminatory and only relate to the specific characteristics of the category of transactions concerned. Article 207 Transfer of or access to source code 1. A Party shall not require the transfer of, or access to, the source code of software owned by a natural or legal person of the other Party. 2. For greater certainty: (a) the general exceptions, security exceptions and prudential carve-out referred to in Article 199 apply to measures of a Party adopted or maintained in the context of a certification procedure; and (b) paragraph 1 of this Article does not apply to the voluntary transfer of, or granting of access to, source code on a commercial basis by a natural or legal person of the other Party, such as in the context of a public procurement transaction or a freely negotiated contract. 3. Nothing in this Article shall affect: (a) a requirement by a court or administrative tribunal, or a requirement by a competition authority pursuant to a Party's competition law to prevent or remedy a restriction or a distortion of competition; (b) a requirement by a regulatory body pursuant to a Party's laws or regulations related to the protection of public safety with regard to users online, subject to safeguards against unauthorised disclosure; (c) the protection and enforcement of intellectual property rights; and (d) the right of a Party to take measures in accordance with Article III of the GPA as incorporated by Article 277 of this Agreement. Article 208 Online consumer trust 1. Recognising the importance of enhancing consumer trust in digital trade, each Party shall adopt or maintain measures to ensure the effective protection of consumers engaging in electronic commerce transactions, including but not limited to measures that: (a) proscribe fraudulent and deceptive commercial practices; (b) require suppliers of goods and services to act in good faith and abide by fair commercial practices, including through the prohibition of charging consumers for unsolicited goods and services; (c) require suppliers of goods or services to provide consumers with clear and thorough information, including when they act through intermediary service suppliers, regarding their identity and contact details, the transaction concerned, including the main characteristics of the goods or services and the full price inclusive of all applicable charges, and the applicable consumer rights (in the case of intermediary service suppliers, this includes enabling the provision of such information by the supplier of goods or services); and (d) grant consumers access to redress for breaches of their rights, including a right to remedies if goods or services are paid for and are not delivered or provided as agreed. 2. The Parties recognise the importance of entrusting their consumer protection agencies or other relevant bodies with adequate enforcement powers and the importance of cooperation between these agencies in order to protect consumers and enhance online consumer trust. Article 209 Unsolicited direct marketing communications 1. Each Party shall ensure that users are effectively protected against unsolicited direct marketing communications. 2. Each Party shall ensure that direct marketing communications are not sent to users who are natural persons unless they have given their consent in accordance with each Party's laws to receiving such communications. 3. Notwithstanding paragraph 2, a Party shall allow natural or legal persons who have collected, in accordance with conditions laid down in the law of that Party, the contact details of a user in the context of the supply of goods or services, to send direct marketing communications to that user for their own similar goods or services. 4. Each Party shall ensure that direct marketing communications are clearly identifiable as such, clearly disclose on whose behalf they are made and contain the necessary information to enable users to request cessation free of charge and at any moment. 5. Each Party shall provide users with access to redress against suppliers of direct marketing communications that do not comply with the measures adopted or maintained pursuant to paragraphs 1 to 4. Article 210 Open government data 1. The Parties recognise that facilitating public access to, and use of, government data contributes to stimulating economic and social development, competitiveness, productivity and innovation. 2. To the extent that a Party chooses to make government data accessible to the public, it shall endeavour to ensure, to the extent practicable, that the data: (a) is in a format that allows it to be easily searched, retrieved, used, reused, and redistributed; (b) is in a machine-readable and spatially-enabled format; (c) contains descriptive metadata, which is as standard as possible; (d) is made available via reliable, user-friendly and freely available Application Programming Interfaces; (e) is regularly updated; (f) is not subject to use conditions that are discriminatory or that unnecessarily restrict re-use; and (g) is made available for re-use in full compliance with the Parties' respective personal data protection rules. 3. The Parties shall endeavour to cooperate to identify ways in which each Party can expand access to, and use of, government data that the Party has made public, with a view to enhancing and generating business opportunities, beyond its use by the public sector. Article 211 Cooperation on regulatory issues with regard to digital trade 1. The Parties shall exchange information on regulatory matters in the context of digital trade, which shall address the following: (a) the recognition and facilitation of interoperable electronic authentication and electronic trust services; (b) the treatment of direct marketing communications; (c) the protection of consumers; and (d) any other matter relevant for the development of digital trade, including emerging technologies. 2. Paragraph 1 shall not apply to a Party's rules and safeguards for the protection of personal data and privacy, including on cross-border transfers of personal data. Article 212 Understanding on computer services 1. The Parties agree that, for the purpose of liberalising trade in services and investment in accordance with Title II of this Heading, the following services shall be considered as computer and related services, regardless of whether they are delivered via a network, including the internet: (a) consulting, adaptation, strategy, analysis, planning, specification, design, development, installation, implementation, integration, testing, debugging, updating, support, technical assistance or management of or for computers or computer systems; (b) computer programmes defined as the sets of instructions required to make computers work and communicate (in and of themselves), as well as consulting, strategy, analysis, planning, specification, design, development, installation, implementation, integration, testing, debugging, updating, adaptation, maintenance, support, technical assistance, management or use of or for computer programmes; (c) data processing, data storage, data hosting or database services; (d) maintenance and repair services for office machinery and equipment, including computers; and (e) training services for staff of clients, related to computer programmes, computers or computer systems, and not elsewhere classified. 2. For greater certainty, services enabled by computer and related services, other than those listed in paragraph 1, shall not be regarded as computer and related services in themselves. TITLE IV CAPITAL MOVEMENTS, PAYMENTS, TRANSFERS AND TEMPORARY SAFEGUARD MEASURES Article 213 Objectives The objective of this Title is to enable the free movement of capital and payments related to transactions liberalised under this Agreement. Article 214 Current account Each Party shall allow, in freely convertible currency and in accordance with the Articles of Agreement of the International Monetary Fund, any payments and transfers with respect to transactions on the current account of the balance of payments that fall within the scope of this Agreement. Article 215 Capital movements 1. Each Party shall allow, with regard to transactions on the capital and financial account of the balance of payments, the free movement of capital for the purpose of liberalisation of investment and other transactions as provided for in Title II of this Heading. 2. The Parties shall consult each other in the Trade Specialised Committee on Services, Investment and Digital Trade to facilitate the movement of capital between them in order to promote trade and investment. Article 216 Measures affecting capital movements, payments or transfers 1. Articles 214 and 215 shall not be construed as preventing a Party from applying its laws and regulations relating to: (a) bankruptcy, insolvency, or the protection of the rights of creditors; (b) issuing, trading or dealing in securities, or futures, options and other financial instruments; (c) financial reporting or record keeping of capital movements, payments or transfers where necessary to assist law enforcement or financial regulatory authorities; (d) criminal or penal offences, deceptive or fraudulent practices; (e) ensuring compliance with orders or judgments in judicial or administrative proceedings; or (f) social security, public retirement or compulsory savings schemes. 2. The laws and regulations referred to in paragraph 1 shall not be applied in an arbitrary or discriminatory manner, or otherwise constitute a disguised restriction on capital movements, payments or transfers. Article 217 Temporary safeguard measures 1. In exceptional circumstances of serious difficulties for the operation of the Union's economic and monetary union, or threat thereof, the Union may adopt or maintain safeguard measures with regard to capital movements, payments or transfers for a period not exceeding six months. 2. The measures referred to in paragraph 1 shall be limited to the extent that is strictly necessary. Article 218 Restrictions in case of balance of payments and external financial difficulties 1. If a Party experiences serious balance of payments or external financial difficulties, or threat thereof, it may adopt or maintain restrictive measures with regard to capital movements, payments or transfers (35). 2. The measures referred to in paragraph 1 shall: (a) be consistent with the Articles of Agreement of the International Monetary Fund; (b) not exceed those necessary to deal with the circumstances described in paragraph 1; (c) be temporary and be phased out progressively as the situation specified in paragraph 1 improves; (d) avoid unnecessary damage to the commercial, economic and financial interests of the other Party; and (e) be non-discriminatory as compared with third countries in like situations. 3. In the case of trade in goods, each Party may adopt or maintain restrictive measures in order to safeguard its external financial position or balance of payments. Those measures shall be in accordance with GATT 1994 and the Understanding on the Balance of Payments provisions of the General Agreement on Tariffs and Trade 1994. 4. In the case of trade in services, each Party may adopt or maintain restrictive measures in order to safeguard its external financial position or balance of payments. Those measures shall be in accordance with Article XII of GATS. 5. A Party maintaining or having adopted measures referred to in paragraphs 1 and 2 shall promptly notify them to the other Party. 6. If a Party adopts or maintains restrictions under this Article, the Parties shall promptly hold consultations in the Trade Specialised Committee on Services, Investment and Digital Trade unless consultations are held in other fora. That Committee shall assess the balance of payments or external financial difficulties that led to the respective measures, taking into account factors such as: (a) the nature and extent of the difficulties; (b) the external economic and trading environment; and (c) alternative corrective measures which may be available. 7. The consultations under paragraph 6 shall address the compliance of any restrictive measures with paragraphs 1 and 2. All relevant findings of a statistical or factual nature presented by the International Monetary Fund, where available, shall be accepted and conclusions shall take into account the assessment by the International Monetary Fund of the balance of payments and the external financial situation of the Party concerned. TITLE V INTELLECTUAL PROPERTY CHAPTER 1 GENERAL PROVISIONS Article 219 Objectives The objectives of this Title are to: (a) facilitate the production, provision and commercialisation of innovative and creative products and services between the Parties by reducing distortions and impediments to such trade, thereby contributing to a more sustainable and inclusive economy; and (b) ensure an adequate and effective level of protection and enforcement of intellectual property rights. Article 220 Scope 1. This Title shall complement and further specify the rights and obligations of each Party under the TRIPS Agreement and other international treaties in the field of intellectual property to which they are parties. 2. This Title does not preclude either Party from introducing more extensive protection and enforcement of intellectual property rights than required under this Title, provided that such protection and enforcement does not contravene this Title. Article 221 Definitions For the purposes of this Title, the following definitions apply: (a) \"Paris Convention\" means the Paris Convention for the Protection of Industrial Property of 20 March 1883, as last revised at Stockholm on 14 July 1967; (b) \"Berne Convention\" means the Berne Convention for the Protection of Literary and Artistic Works of 9 September 1886 revised at Paris on 24 July 1971 and amended on 28 September 1979; (c) \"Rome Convention\" means the International Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organisations done at Rome on 26 October 1961; (d) \"WIPO\" means the World Intellectual Property Organisation; (e) \"intellectual property rights\" means all categories of intellectual property that are covered by Articles 225 to 255 of this Agreement or Sections 1 to 7 of Part II of the TRIPS Agreement. The protection of intellectual property includes protection against unfair competition as referred to in Article 10bis of the Paris Convention; (f) \"national\" means, in respect of the relevant intellectual property right, a person of a Party that would meet the criteria for eligibility for protection provided for in the TRIPS Agreement and multilateral agreements concluded and administered under the auspices of WIPO, to which a Party is a contracting party. Article 222 International agreements 1. The Parties affirm their commitment to comply with the international agreements to which they are party: (a) the TRIPS Agreement; (b) the Rome Convention; (c) the Berne Convention; (d) the WIPO Copyright Treaty, adopted at Geneva on 20 December 1996; (e) the WIPO Performances and Phonograms Treaty, adopted at Geneva on 20 December 1996; (f) the Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks, adopted at Madrid on 27 June 1989, as last amended on 12 November 2007; (g) the Trademark Law Treaty, adopted at Geneva on 27 October 1994; (h) the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled, adopted at Marrakesh on 27 June 2013; (i) the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs, adopted at Geneva on 2 July 1999. 2. Each Party shall make all reasonable efforts to ratify or accede to the following international agreements: (a) the Beijing Treaty on Audiovisual Performances, adopted at Beijing on 24 June 2012; (b) the Singapore Treaty on the Law of Trademarks adopted at Singapore on 27 March 2006. Article 223 Exhaustion This Title does not affect the freedom of the parties to determine whether and under what conditions the exhaustion of intellectual property rights applies. Article 224 National treatment 1. In respect of all categories of intellectual property covered by this Title, each Party shall accord to the nationals of the other Party treatment no less favourable than the treatment it accords to its own nationals with regard to the protection of intellectual property subject where applicable to the exceptions already provided for in, respectively, the Paris Convention, the Berne Convention, the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits, done at Washington on 26 May 1989. In respect of performers, producers of phonograms and broadcasting organisations, this obligation only applies in respect of the rights provided for under this Agreement. 2. For the purposes of paragraph 1 of this Article, \"protection\" shall include matters affecting the availability, acquisition, scope, maintenance, and enforcement of intellectual property rights as well as matters affecting the use of intellectual property rights specifically addressed in this Title, including measures to prevent the circumvention of effective technological measures as referred to in Article 234 and measures concerning rights management information as referred to in Article 235. 3. A Party may avail itself of the exceptions permitted pursuant to paragraph 1 in relation to its judicial and administrative procedures, including requiring a national of the other Party to designate an address for service in its territory, or to appoint an agent in its territory, if such exceptions are: (a) necessary to secure compliance with the Party's laws or regulations which are not inconsistent with this Title; or (b) not applied in a manner which would constitute a disguised restriction on trade. 4. Paragraph 1 does not apply to procedures provided in multilateral agreements concluded under the auspices of WIPO relating to the acquisition or maintenance of intellectual property rights. CHAPTER 2 STANDARDS CONCERNING INTELLECTUAL PROPERTY RIGHTS SECTION 1 COPYRIGHT AND RELATED RIGHTS Article 225 Authors Each Party shall provide authors with the exclusive right to authorise or prohibit: (a) direct or indirect, temporary or permanent reproduction by any means and in any form, in whole or in part, of their works; (b) any form of distribution to the public by sale or otherwise of the original of their works or of copies thereof; (c) any communication to the public of their works by wire or wireless means, including the making available to the public of their works in such a way that members of the public may access them from a place and at a time individually chosen by them; (d) the commercial rental to the public of originals or copies of their works; each Party may provide that this point does not apply to buildings or works of applied art. Article 226 Performers Each Party shall provide performers with the exclusive right to authorise or prohibit: (a) the fixation of their performances; (b) the direct or indirect, temporary or permanent reproduction by any means and in any form, in whole or in part, of fixations of their performances; (c) the distribution to the public, by sale or otherwise, of the fixations of their performances; (d) the making available to the public of fixations of their performances, by wire or wireless means, in such a way that members of the public may access them from a place and at a time individually chosen by them; (e) the broadcasting by wireless means and the communication to the public of their performances, except where the performance is itself already a broadcast performance or is made from a fixation; (f) the commercial rental to the public of the fixation of their performances. Article 227 Producers of phonograms Each Party shall provide phonogram producers with the exclusive right to authorise or prohibit: (a) the direct or indirect, temporary or permanent, reproduction by any means and in any form, in whole or in part, of their phonograms; (b) the distribution to the public, by sale or otherwise, of their phonograms, including copies thereof; (c) the making available to the public of their phonograms, by wire or wireless means, in such a way that members of the public may access them from a place and at a time individually chosen by them; (d) the commercial rental of their phonograms to the public. Article 228 Broadcasting organisations Each Party shall provide broadcasting organisations with the exclusive right to authorise or prohibit: (a) the fixation of their broadcasts, whether these broadcasts are transmitted by wire or over the air, including by cable or satellite; (b) the direct or indirect, temporary or permanent reproduction by any means and in any form, in whole or in part, of fixations of their broadcasts, whether those broadcasts are transmitted by wire or over the air, including by cable or satellite; (c) the making available to the public, by wire or wireless means, of fixations of their broadcasts, whether those broadcasts are transmitted by wire or over the air, including by cable or satellite, in such a way that members of the public may access them from a place and at a time individually chosen by them; (d) the distribution to the public, by sale or otherwise, of fixations, including copies thereof, of their broadcasts, whether these broadcasts are transmitted by wire or over the air, including by cable or satellite; (e) the rebroadcasting of their broadcasts by wireless means, as well as the communication to the public of their broadcasts if such communication is made in places accessible to the public against payment of an entrance fee. Article 229 Broadcasting and communication to the public of phonograms published for commercial purposes 1. Each Party shall provide a right in order to ensure that a single equitable remuneration is paid by the user to the performers and producers of phonograms, if a phonogram published for commercial purposes, or a reproduction of such phonogram, is used for broadcasting or any communication to the public. 2. Each Party shall ensure that the single equitable remuneration is shared between the relevant performers and phonogram producers. Each Party may enact legislation that, in the absence of an agreement between performers and producers of phonograms, sets the terms according to which performers and producers of phonograms shall share the single equitable remuneration. 3. Each Party may grant more extensive rights, as regards the broadcasting and communication to the public of phonograms published for commercial purposes, to performers and producers of phonograms. Article 230 Term of protection 1. The rights of an author of a work shall run for the life of the author and for 70 years after the author's death, irrespective of the date when the work is lawfully made available to the public. 2. For the purpose of implementing paragraph 1, each Party may provide for specific rules on the calculation of the term of protection of musical composition with words, works of joint authorship as well as cinematographic or audiovisual works. Each Party may provide for specific rules on the calculation of the term of protection of anonymous or pseudonymous works. 3. The rights of broadcasting organisations shall expire 50 years after the first transmission of a broadcast, whether this broadcast is transmitted by wire or over the air, including by cable or satellite. 4. The rights of performers for their performances otherwise than in phonograms shall expire 50 years after the date of the fixation of the performance or, if lawfully published or lawfully communicated to the public during this time, 50 years from the first such publication or communication to the public, whichever is the earlier. 5. The rights of performers for their performances fixed in phonograms shall expire 50 years after the date of fixation of the performance or, if lawfully published or lawfully communicated to the public during this time, 70 years from such act, whichever is the earlier. 6. The rights of producers of phonograms shall expire 50 years after the fixation is made or, if lawfully published to the public during this time, 70 years from such publication. In the absence of a lawful publication, if the phonogram has been lawfully communicated to the public during this time, the term of protection shall be 70 years from such act of communication. Each Party may provide for effective measures in order to ensure that the profit generated during the 20 years of protection beyond 50 years is shared fairly between the performers and the producers of phonograms. 7. The terms laid down in this Article shall be counted from the first of January of the year following the year of the event which gives rise to them. 8. Each Party may provide for longer terms of protection than those provided for in this Article. Article 231 Resale right 1. Each Party shall provide, for the benefit of the author of an original work of graphic or plastic art, a resale right, to be defined as an inalienable right, which cannot be waived, even in advance, to receive a royalty based on the sale price obtained for any resale of the work, subsequent to the first transfer of the work by the author. 2. The right referred to in paragraph 1 shall apply to all acts of resale involving as sellers, buyers or intermediaries art market professionals, such as salesrooms, art galleries and, in general, any dealers in works of art. 3. Each Party may provide that the right referred to in paragraph 1 shall not apply to acts of resale, where the seller has acquired the work directly from the author less than three years before that resale and where the resale price does not exceed a certain minimum amount. 4. The procedure for collection of the remuneration and their amounts shall be determined by the law of each Party. Article 232 Collective management of rights 1. The Parties shall promote cooperation between their respective collective management organisations for the purpose of fostering the availability of works and other protected subject matter in their respective territories and the transfer of rights revenue between the respective collective management organisations for the use of such works or other protected subject matter. 2. The Parties shall promote the transparency of collective management organisations, in particular regarding the rights revenue they collect, the deductions they apply to the rights revenue they collect, the use of the rights revenue collected, the distribution policy and their repertoire. 3. The Parties shall endeavour to facilitate arrangements between their respective collective management organisations on non-discriminatory treatment of right holders whose rights these organisations manage under representation agreements. 4. The Parties shall cooperate to support the collective management organisations established in their territory and representing another collective management organisation established in the territory of the other Party by way of a representation agreement with a view to ensuring that they accurately, regularly and diligently pay amounts owed to the represented collective management organisations and provide the represented collective management organisation with the information on the amount of rights revenue collected on its behalf and any deductions made to that rights revenue. Article 233 Exceptions and limitations Each Party shall confine limitations or exceptions to the rights set out in Articles 225 to 229 to certain special cases which do not conflict with a normal exploitation of the work or other subject-matter and do not unreasonably prejudice the legitimate interests of the right holders. Article 234 Protection of technological measures 1. Each Party shall provide adequate legal protection against the circumvention of any effective technological measures, which the person concerned carries out in the knowledge, or with reasonable grounds to know, that he or she is pursuing that objective. Each Party may provide for a specific regime for legal protection of technological measures used to protect computer programs. 2. Each Party shall provide adequate legal protection against the manufacture, import, distribution, sale, rental, advertisement for sale or rental, or possession for commercial purposes of devices, products or components or the provision of services which: (a) are promoted, advertised or marketed for the purpose of circumvention of; (b) have only a limited commercially significant purpose or use other than to circumvent; or (c) are primarily designed, produced, adapted or performed for the purpose of enabling or facilitating the circumvention of, any effective technological measures. 3. For the purposes of this Section, the expression \"technological measures\" means any technology, device or component that, in the normal course of its operation, is designed to prevent or restrict acts, in respect of works or other subject-matter, which are not authorised by the right holder of any copyright or related right covered by this Section. Technological measures shall be deemed \"effective\" where the use of a protected work or other subject matter is controlled by the right holders through application of an access control or protection process, such as encryption, scrambling or other transformation of the work or other subject-matter or a copy control mechanism, which achieves the protection objective. 4. Notwithstanding the legal protection provided for in paragraph 1 of this Article, each Party may take appropriate measures, as necessary, to ensure that the adequate legal protection against the circumvention of effective technological measures provided for in accordance with this Article does not prevent beneficiaries of exceptions or limitations provided for in accordance with Article 233 from enjoying such exceptions or limitations. Article 235 Obligations concerning rights management information 1. Each Party shall provide adequate legal protection against any person knowingly performing without authority any of the following acts: (a) the removal or alteration of any electronic rights-management information; (b) the distribution, importation for distribution, broadcasting, communication or making available to the public of works or other subject-matter protected pursuant to this Section from which electronic rights-management information has been removed or altered without authority; if such person knows, or has reasonable grounds to know, that by so doing he or she is inducing, enabling, facilitating or concealing an infringement of any copyright or any related rights as provided by the law of a Party. 2. For the purposes of this Article, \"rights-management information\" means any information provided by right holders which identifies the work or other subject-matter referred to in this Article, the author or any other right holder, or information about the terms and conditions of use of the work or other subject-matter, and any numbers or codes that represent such information. 3. Paragraph 2 applies if any of these items of information is associated with a copy of, or appears in connection with the communication to the public of, a work or other subject-matter referred to in this Article. SECTION 2 TRADE MARKS Article 236 Trade mark classification Each Party shall maintain a trade mark classification system that is consistent with the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks of 15 June 1957, as amended and revised. Article 237 Signs of which a trade mark may consist A trade mark may consist of any signs, in particular words, including personal names, or designs, letters, numerals, colours, the shape of goods or of the packaging of goods, or sounds, provided that such signs are capable of: (a) distinguishing the goods or services of one undertaking from those of other undertakings; and (b) being represented on the respective trade mark register of each Party, in a manner which enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor. Article 238 Rights conferred by a trade mark 1. Each Party shall provide that the registration of a trade mark confers on the proprietor exclusive rights therein. The proprietor shall be entitled to prevent all third parties not having the proprietor's consent from using in the course of trade: (a) any sign which is identical with the registered trade mark in relation to goods or services which are identical with those for which the trade mark is registered; (b) any sign where, because of its identity with, or similarity to, the registered trade mark and the identity or similarity of the goods or services covered by this trade mark and the sign, there exists a likelihood of confusion on the part of the public, including the likelihood of association between the sign and the registered trade mark. 2. The proprietor of a registered trade mark shall be entitled to prevent all third parties from bringing goods, in the course of trade, into the Party where the trade mark is registered without being released for free circulation there, where such goods, including packaging, come from other countries or the other Party and bear without authorisation a trade mark which is identical to the trade mark registered in respect of such goods, or which cannot be distinguished in its essential aspects from that trade mark. 3. The entitlement of the proprietor of a trade mark pursuant to paragraph 2 shall lapse if during the proceedings to determine whether the registered trade mark has been infringed, evidence is provided by the declarant or the holder of the goods that the proprietor of the registered trade mark is not entitled to prohibit the placing of the goods on the market in the country of final destination. Article 239 Registration procedure 1. Each Party shall provide for a system for the registration of trade marks in which each final negative decision taken by the relevant trade mark administration, including partial refusals of registration, shall be communicated in writing to the relevant party, duly reasoned and subject to appeal. 2. Each Party shall provide for the possibility for third parties to oppose trade mark applications or, where appropriate, trade mark registrations. Such opposition proceedings shall be adversarial. 3. Each Party shall provide a publicly available electronic database of trade mark applications and trade mark registrations. 4. Each Party shall make best efforts to provide a system for the electronic application for and processing, registration and maintenance of trade marks. Article 240 Well-known trade marks For the purpose of giving effect to protection of well-known trade marks, as referred to in Article 6bis of the Paris Convention and Article 16(2) and (3) of the TRIPS Agreement, each Party shall apply the Joint Recommendation Concerning Provisions on the Protection of Well-Known Marks, adopted by the Assembly of the Paris Union for the Protection of Industrial Property and the General Assembly of the WIPO at the Thirty-Fourth Series of Meetings of the Assemblies of the Member States of WIPO on 20 to 29 September 1999. Article 241 Exceptions to the rights conferred by a trade mark 1. Each Party shall provide for limited exceptions to the rights conferred by a trade mark such as the fair use of descriptive terms including geographical indications, and may provide other limited exceptions, provided such exceptions take account of the legitimate interests of the proprietor of the trade mark and of third parties. 2. The trade mark shall not entitle the proprietor to prohibit a third party from using, in the course of trade: (a) the name or address of the third party, where the third party is a natural person; (b) signs or indications concerning the kind, quality, quantity, intended purpose, value, geographical origin, the time of production of goods or of rendering of the service, or other characteristics of goods or services; or (c) the trade mark for the purpose of identifying or referring to goods or services as those of the proprietor of that trade mark, in particular where the use of that trade mark is necessary to indicate the intended purpose of a product or service, in particular as accessories or spare parts, provided the third party uses them in accordance with honest practices in industrial or commercial matters. 3. The trade mark shall not entitle the proprietor to prohibit a third party from using, in the course of trade, an earlier right which only applies in a particular locality if that right is recognised by the laws of the Party in question and is used within the limits of the territory in which it is recognised. Article 242 Grounds for revocation 1. Each Party shall provide that a trade mark shall be liable to revocation if, within a continuous period of five years it has not been put to genuine use in the relevant territory of a Party by the proprietor or with the proprietor's consent in relation to the goods or services for which it is registered, and there are no proper reasons for non-use. 2. Each Party shall also provide that a trade mark shall be liable to revocation if within the period of five years following the date of completion of the registration procedure it has not been put to genuine use in the relevant territory by the proprietor or with the proprietor's consent, in relation to the goods or services for which it is registered, and there are no proper reasons for non-use. 3. However, no person may claim that the proprietor's rights in a trade mark should be revoked where, during the interval between expiry of the five-year period and filing of the application for revocation, genuine use of the trade mark has been started or resumed. The commencement or resumption of use within a period of three months preceding the filing of the application for revocation which began at the earliest on expiry of the continuous period of five years of non-use, shall, however, be disregarded where preparations for the commencement or resumption occur only after the proprietor becomes aware that the application for revocation may be filed. 4. A trade mark shall also be liable to revocation if, after the date on which it was registered: (a) as a consequence of acts or inactivity of the proprietor, it has become the common name in the trade for a good or service in respect of which it is registered; (b) as a consequence of the use made of the trade mark by the proprietor of the trade mark or with the proprietor's consent in respect of the goods or services for which it is registered, it is liable to mislead the public, particularly as to the nature, quality or geographical origin of those goods or services. Article 243 The right to prohibit preparatory acts in relation to the use of packaging or other means Where the risk exists that the packaging, labels, tags, security or authenticity features or devices, or any other means to which the trade mark is affixed could be used in relation to goods or services and that use would constitute an infringement of the rights of the proprietor of the trade mark, the proprietor of that trade mark shall have the right to prohibit the following acts if carried out in the course of trade: (a) affixing a sign identical with, or similar to, the trade mark on packaging, labels, tags, security or authenticity features or devices, or any other means to which the mark may be affixed; or (b) offering or placing on the market, or stocking for those purposes, or importing or exporting, packaging, labels, tags, security or authenticity features or devices, or any other means to which the mark is affixed. Article 244 Bad faith applications A trade mark shall be liable to be declared invalid where the application for registration of the trade mark was made in bad faith by the applicant. Each Party may provide that such a trade mark shall not be registered. SECTION 3 DESIGN Article 245 Protection of registered designs 1. Each Party shall provide for the protection of independently created designs that are new and original. This protection shall be provided by registration and shall confer exclusive rights upon their holders in accordance with this Section. For the purposes of this Article, a Party may consider that a design having individual character is original. 2. The holder of a registered design shall have the right to prevent third parties not having the holder's consent at least from making, offering for sale, selling, importing, exporting, stocking the product bearing and embodying the protected design or using articles bearing or embodying the protected design where such acts are undertaken for commercial purposes. 3. A design applied to or incorporated in a product which constitutes a component part of a complex product shall only be considered to be new and original: (a) if the component part, once it has been incorporated into the complex product, remains visible during normal use of the latter; and (b) to the extent that those visible features of the component part fulfil in themselves the requirements as to novelty and originality. 4. For the purposes of point (a) of paragraph 3, \"normal use\" means use by the end user, excluding maintenance, servicing or repair work. Article 246 Duration of protection The duration of protection available for registered designs, including renewals of registered designs, shall amount to a total term of 25 years from the date on which the application was filed (36). Article 247 Protection of unregistered designs 1. Each Party shall confer on holders of an unregistered design the right to prevent the use of the unregistered design by any third party not having the holder's consent only if the contested use results from copying the unregistered design in their respective territory (37). Such use shall at least cover the offering for sale, putting on the market, importing or exporting the product. 2. The duration of protection available for the unregistered design shall amount to at least three years as from the date on which the design was first made available to the public in the territory of the respective Party. Article 248 Exceptions and exclusions 1. Each Party may provide limited exceptions to the protection of designs, including unregistered designs, provided that such exceptions do not unreasonably conflict with the normal exploitation of designs, and do not unreasonably prejudice the legitimate interests of the holder of the design, taking account of the legitimate interests of third parties. 2. Protection shall not extend to designs solely dictated by technical or functional considerations. A design shall not subsist in features of appearance of a product which must necessarily be reproduced in their exact form and dimensions in order to permit the product in which the design is incorporated or to which it is applied to be mechanically connected to or placed in, around or against another product so that either product may perform its function. 3. By way of derogation from paragraph 2 of this Article, a design shall, in accordance with the conditions set out in Article 245(1), subsist in a design, which has the purpose of allowing the multiple assembly or connection of mutually interchangeable products within a modular system. Article 249 Relationship to copyright Each Party shall ensure that designs, including unregistered designs, shall also be eligible for protection under the copyright law of that Party as from the date on which the design was created or fixed in any form. The extent to which, and the conditions under which, such a protection is conferred, including the level of originality required, shall be determined by each Party. SECTION 4 PATENTS Article 250 Patents and public health 1. The Parties recognise the importance of the Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 by the Ministerial Conference of the WTO at Doha (the \"Doha Declaration\"). In interpreting and implementing the rights and obligations under this Section, each Party shall ensure consistency with the Doha Declaration. 2. Each Party shall implement Article 31bis of the TRIPS Agreement, as well as the Annex to the TRIPS Agreement and the Appendix to the Annex to the TRIPS Agreement. Article 251 Extension of the period of protection conferred by a patent on medicinal products and on plant protection products 1. The Parties recognise that medicinal products and plant protection products (38) protected by a patent in their respective territory may be subject to an administrative authorisation procedure before being put on their respective markets. The Parties recognise that the period that elapses between the filing of the application for a patent and the first authorisation to place the product on the market, as defined for that purpose by the relevant legislation, may shorten the period of effective protection under the patent. 2. Each Party shall provide for further protection, in accordance with its laws and regulations, for a product which is protected by a patent and which has been subject to an administrative authorisation procedure referred to in paragraph 1 to compensate the holder of a patent for the reduction of effective patent protection. The terms and conditions for the provision of such further protection, including its length, shall be determined in accordance with the laws and regulations of the Parties. 3. For the purposes of this Title, \"medicinal product\" means: (a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings or animals; or (b) any substance or combination of substances which may be used in or administered to human beings or animals either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. SECTION 5 PROTECTION OF UNDISCLOSED INFORMATION Article 252 Protection of trade secrets 1. Each Party shall provide for appropriate civil judicial procedures and remedies for any trade secret holder to prevent, and obtain redress for, the acquisition, use or disclosure of a trade secret whenever carried out in a manner contrary to honest commercial practices. 2. For the purposes of this Section, the following definitions apply: (a) \"trade secret\" means information which meets all of the following requirements: (i) it is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (ii) it has commercial value because it is secret; and (iii) it has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret; (b) \"trade secret holder\" means any natural or legal person lawfully controlling a trade secret. 3. For the purposes of this Section, at least the following conduct shall be considered contrary to honest commercial practices: (a) the acquisition of a trade secret without the consent of the trade secret holder, whenever obtained by unauthorised access to, or by appropriation or copying of, any documents, objects, materials, substances or electronic files that are lawfully under the control of the trade secret holder, and that contain the trade secret or from which the trade secret can be deduced; (b) the use or disclosure of a trade secret whenever it is carried out, without the consent of the trade secret holder, by a person who is found to meet any of the following conditions: (i) having acquired the trade secret in a manner referred to in point (a); (ii) being in breach of a confidentiality agreement or any other duty not to disclose the trade secret; or (iii) being in breach of a contractual or any other duty to limit the use of the trade secret; (c) the acquisition, use or disclosure of a trade secret whenever carried out by a person who, at the time of the acquisition, use or disclosure, knew, or ought to have known, under the circumstances that the trade secret had been obtained directly or indirectly from another person who was using or disclosing the trade secret unlawfully within the meaning of point (b). 4. Nothing in this Section shall be understood as requiring either Party to consider any of the following conducts as contrary to honest commercial practices: (a) independent discovery or creation; (b) the reverse engineering of a product that has been made available to the public or that is lawfully in the possession of the acquirer of the information, where the acquirer of the information is free from any legally valid duty to limit the acquisition of the trade secret; (c) the acquisition, use or disclosure of a trade secret required or allowed by the law of each Party; (d) the exercise of the right of workers or workers' representatives to information and consultation in accordance with the laws and regulations of that Party. 5. Nothing in this Section shall be understood as affecting the exercise of freedom of expression and information, including the freedom and pluralism of the media, as protected in each Party, restricting the mobility of employees, or as affecting the autonomy of social partners and their right to enter into collective agreements, in accordance with the laws and regulations of the Parties. Article 253 Protection of data submitted to obtain an authorisation to put a medicinal product on the market 1. Each Party shall protect commercially confidential information submitted to obtain an authorisation to place medicinal products on the market (\"marketing authorisation\") against disclosure to third parties, unless steps are taken to ensure that the data are protected against unfair commercial use or except where the disclosure is necessary for an overriding public interest. 2. Each Party shall ensure that for a limited period of time to be determined by its domestic law and in accordance with any conditions set out in its domestic law, the authority responsible for the granting of a marketing authorisation does not accept any subsequent application for a marketing authorisation that relies on the results of pre-clinical tests or clinical trials submitted in the application to that authority for the first marketing authorisation, without the explicit consent of the holder of the first marketing authorisation, unless international agreements to which the Parties are both party provide otherwise. 3. Each Party shall also ensure that, for a limited period of time to be determined by its domestic law and in accordance with any conditions set out in its domestic law, a medicinal product subsequently authorised by that authority on the basis of the results of the pre-clinical tests and clinical trials referred to in paragraph 2 is not placed on the market without the explicit consent of the holder of the first marketing authorisation, unless international agreements to which the Parties are both party provide otherwise. 4. This Article is without prejudice to additional periods of protection which each Party may provide in that Party's law. Article 254 Protection of data submitted to obtain marketing authorisation for plant protection products or biocidal products 1. Each Party shall recognise a temporary right of the owner of a test or study report submitted for the first time to obtain a marketing authorisation concerning safety and efficacy of an active substance, plant protection product or biocidal product. During such period, the test or study report shall not be used for the benefit of any other person who seeks to obtain a marketing authorisation for an active substance, plant protection product or biocidal product, unless the explicit consent of the first owner has been proved. For the purposes of this Article, that right is referred to as data protection. 2. The test or study report submitted for marketing authorisation of an active substance or plant protection product should fulfil the following conditions: (a) be necessary for the authorisation or for an amendment of an authorisation in order to allow the use on other crops; and (b) be certified as compliant with the principles of good laboratory practice or of good experimental practice. 3. The period of data protection shall be at least 10 years from the grant of the first authorisation by a relevant authority in the territory of the Party. 4. Each Party shall ensure that the public bodies responsible for the granting of a marketing authorisation will not use the information referred to in paragraphs 1 and 2 for the benefit of a subsequent applicant for any successive marketing authorisation, regardless whether or not it has been made available to the public. 5. Each Party shall establish rules to avoid duplicative testing on vertebrate animals. SECTION 6 PLANT VARIETIES Article 255 Protection of plant varieties rights Each Party shall protect plant varieties rights in accordance with the International Convention for the Protection of New Varieties of Plants (UPOV) as lastly revised in Geneva on 19 March 1991. The Parties shall cooperate to promote and enforce these rights. CHAPTER 3 ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS SECTION 1 GENERAL PROVISIONS Article 256 General obligations 1. Each Party shall provide under its respective law for the measures, procedures and remedies necessary to ensure the enforcement of intellectual property rights. For the purposes of Sections 1, 2 and 4 of this Chapter, the term \"intellectual property rights\" does not include rights covered by Section 5 of Chapter 2. 2. The measures, procedures and remedies referred to in paragraph 1 shall: (a) be fair and equitable; (b) not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays; (c) be effective, proportionate and dissuasive; (d) be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse. Article 257 Persons entitled to apply for the application of the measures, procedures and remedies Each Party shall recognise as persons entitled to seek application of the measures, procedures and remedies referred to in Sections 2 and 4 of this Chapter: (a) the holders of intellectual property rights in accordance with the law of a Party; (b) all other persons authorised to use those rights, in particular licensees, in so far as permitted by and in accordance with the law of a Party; and (c) federations and associations (39), in so far as permitted by and in accordance with the law of a Party. SECTION 2 CIVIL AND ADMINISTRATIVE ENFORCEMENT Article 258 Measures for preserving evidence 1. Each Party shall ensure that, even before the commencement of proceedings on the merits of the case, the competent judicial authorities may, on application by a party who has presented reasonably available evidence to support their claims that their intellectual property right has been infringed or is about to be infringed, order prompt and effective provisional measures to preserve relevant evidence in respect of the alleged infringement, subject to appropriate safeguards and the protection of confidential information. 2. Such measures may include the detailed description, with or without the taking of samples, or the physical seizure of the alleged infringing goods, and, in appropriate cases, the materials and implements used in the production and/or distribution of these goods and the documents relating thereto. Article 259 Evidence 1. Each Party shall take the measures necessary to enable the competent judicial authorities to order, on application by a party which has presented reasonably available evidence sufficient to support its claims and has, in substantiating those claims, specified evidence which lies in the control of the opposing party, that this evidence be produced by the opposing party, subject to the protection of confidential information. 2. Each Party shall also take the necessary measures to enable the competent judicial authorities to order, where appropriate, in cases of infringement of an intellectual property right committed on a commercial scale, under the same conditions as in paragraph 1, the communication of banking, financial or commercial documents under the control of the opposing party, subject to the protection of confidential information. Article 260 Right of information 1. Each Party shall ensure that, in the context of civil proceedings concerning an infringement of an intellectual property right and in response to a justified and proportionate request of the claimant, the competent judicial authorities may order the infringer or any other person to provide information on the origin and distribution networks of the goods or services which infringe an intellectual property right. 2. For the purposes of paragraph 1 \"any other person\" means a person who: (a) was found in possession of the infringing goods on a commercial scale; (b) was found to be using the infringing services on a commercial scale; (c) was found to be providing on a commercial scale services used in infringing activities; or (d) was indicated by the person referred to in point (a), (b) or (c), as being involved in the production, manufacture or distribution of the goods or the provision of the services. 3. The information referred to in paragraph 1 shall, as appropriate, comprise: (a) the names and addresses of the producers, manufacturers, distributors, suppliers and other previous holders of the goods or services, as well as the intended wholesalers and retailers; (b) information on the quantities produced, manufactured, delivered, received or ordered, as well as the price obtained for the goods or services in question. 4. Paragraphs 1 and 2 shall apply without prejudice to other laws of a Party which: (a) grant the right holder rights to receive fuller information; (b) govern the use in civil proceedings of the information communicated pursuant to this Article; (c) govern responsibility for misuse of the right of information; (d) afford an opportunity for refusing to provide information which would force the person referred to in paragraph 1 to admit their own participation or that of their close relatives in an infringement of an intellectual property right; (e) govern the protection of confidentiality of information sources or the processing of personal data. Article 261 Provisional and precautionary measures 1. Each Party shall ensure that its judicial authorities may, at the request of the applicant, issue against the alleged infringer an interlocutory injunction intended to prevent any imminent infringement of an intellectual property right, or to forbid, on a provisional basis and subject, where appropriate, to a recurring penalty payment where provided for by the law of that Party, the continuation of the alleged infringements of that right, or to make such continuation subject to the lodging of guarantees intended to ensure the compensation of the right holder. An interlocutory injunction may also be issued, under the same conditions, against an intermediary whose services are being used by a third party to infringe an intellectual property right. 2. Each Party shall ensure that its judicial authorities may, at the request of the applicant, order the seizure or delivery up of goods suspected of infringing an intellectual property right, so as to prevent their entry into or movement within the channels of commerce. 3. In the case of an alleged infringement committed on a commercial scale, each Party shall ensure that, if the applicant demonstrates circumstances likely to endanger the recovery of damages, the judicial authorities may order the precautionary seizure of the movable and immovable property of the alleged infringer, including the blocking of their bank accounts and other assets. To that end, the competent authorities may order the communication of bank, financial or commercial documents, or appropriate access to the relevant information. 4. Each Party shall ensure that its judicial authorities shall, in respect of the measures referred to in paragraphs 1, 2 and 3, have the authority to require the applicant to provide any reasonably available evidence in order to satisfy themselves with a sufficient degree of certainty that the applicant is the right holder and that the applicant's right is being infringed, or that such infringement is imminent. Article 262 Corrective measures 1. Each Party shall ensure that its judicial authorities may order, at the request of the applicant, without prejudice to any damages due to the right holder by reason of the infringement, and without compensation of any sort, the destruction of goods that they have found to be infringing an intellectual property right or at least the definitive removal of those goods from the channels of commerce. If appropriate, under the same conditions, the judicial authorities may also order destruction of materials and implements predominantly used in the creation or manufacture of those goods. 2. Each Party's judicial authorities shall have the authority to order that those measures shall be carried out at the expense of the infringer, unless particular reasons are invoked for not doing so. Article 263 Injunctions Each Party shall ensure that, where a judicial decision is taken finding an infringement of an intellectual property right, the judicial authorities may issue against the infringer an injunction aimed at prohibiting the continuation of the infringement. Each Party shall also ensure that the judicial authorities may issue an injunction against intermediaries whose services are used by a third party to infringe an intellectual property right. Article 264 Alternative measures Each Party may provide that the judicial authorities, in appropriate cases and at the request of the person liable to be subject to the measures provided for in Article 262 or 263, may order pecuniary compensation to be paid to the injured party instead of applying the measures provided for in these two Articles if that person acted unintentionally and without negligence, if execution of the measures in question would cause the person disproportionate harm and if pecuniary compensation to the injured party appears reasonably satisfactory. Article 265 Damages 1. Each Party shall ensure that its judicial authorities, on application of the injured party, order the infringer who knowingly engaged, or had reasonable grounds to know it was engaging, in an infringing activity, to pay to the right holder damages appropriate to the actual prejudice suffered by the right holder as a result of the infringement. 2. Each Party shall ensure that when its judicial authorities set the damages: (a) they take into account all appropriate aspects, such as the negative economic consequences, including lost profits, which the injured party has suffered, any unfair profits made by the infringer and, in appropriate cases, elements other than economic factors, such as the moral prejudice caused to the right holder by the infringement; or (b) as an alternative to point (a), they may, in appropriate cases, set the damages as a lump sum on the basis of elements such as at least the amount of royalties or fees which would have been due if the infringer had requested authorisation to use the intellectual property right in question. 3. Where the infringer did not knowingly, or with reasonable grounds to know, engage in infringing activity, each Party may lay down that the judicial authorities may order the recovery of profits or the payment of damages which may be pre-established. Article 266 Legal costs Each Party shall ensure that reasonable and proportionate legal costs and other expenses incurred by the successful party shall, as a general rule, be borne by the unsuccessful party, unless equity does not allow this. Article 267 Publication of judicial decisions Each Party shall ensure that, in legal proceedings instituted for infringement of an intellectual property right, the judicial authorities may order, at the request of the applicant and at the expense of the infringer, appropriate measures for the dissemination of the information concerning the decision, including displaying the decision and publishing it in full or in part. Article 268 Presumption of authorship or ownership For the purposes of applying the measures, procedures and remedies provided for in Chapter 3: (a) for the author of a literary or artistic work, in the absence of proof to the contrary, to be regarded as such, and consequently to be entitled to institute infringement proceedings, it shall be sufficient for the author's name to appear on the work in the usual manner; and (b) point (a) applies mutatis mutandis to the holders of rights related to copyright with regard to their protected subject matter. Article 269 Administrative procedures To the extent that any civil remedy can be ordered on the merits of a case as a result of administrative procedures, such procedures shall conform to principles equivalent in substance to those set forth in this Section. SECTION 3 CIVIL JUDICIAL PROCEDURES AND REMEDIES OF TRADE SECRETS Article 270 Civil judicial procedures and remedies of trade secrets 1. Each Party shall ensure that any person participating in the civil judicial proceedings referred to in Article 252(1), or who has access to documents which form part of those proceedings, is not permitted to use or disclose any trade secret or alleged trade secret which the competent judicial authorities have, in response to a duly reasoned application by an interested party, identified as confidential and of which they have become aware as a result of such participation or access. 2. Each Party shall ensure that the obligation referred to in paragraph 1 remains in force after the civil judicial proceedings have ended, for as long as appropriate. 3. In the civil judicial proceedings referred to Article 252(1), each Party shall provide that its judicial authorities have the authority at least to: (a) order provisional measures, in accordance with their respective laws and regulations, to cease and prohibit the use or disclosure of the trade secret in a manner contrary to honest commercial practices; (b) order measures, in accordance with their respective laws and regulations, ordering the cessation of, or as the case may be, the prohibition of the use or disclosure of the trade secret in a manner contrary to honest commercial practices; (c) order, in accordance with their respective laws and regulations, any person who has acquired, used or disclosed a trade secret in a manner contrary to honest commercial practices and that knew or ought to have known that he or she or it was acquiring, using or disclosing a trade secret in a manner contrary to honest commercial practices to pay the trade secret holder damages appropriate to the actual prejudice suffered as a result of such acquisition, use or disclosure of the trade secret; (d) take specific measures necessary to preserve the confidentiality of any trade secret or alleged trade secret used or referred to in proceedings as referred to in Article 252(1). Such specific measures may include, in accordance with each Party's respective laws and regulations, including the rights of defence, the possibility of restricting access to certain documents in whole or in part; of restricting access to hearings and their corresponding records or transcript; and of making available a non-confidential version of judicial decision in which the passages containing trade secrets have been removed or redacted. (e) impose sanctions on any person participating in the legal proceedings who fail or refuse to comply with the court orders concerning the protection of the trade secret or alleged trade secret. 4. Each Party shall ensure that an application for the measure, procedures or remedies provided for in this Article is dismissed where the alleged acquisition, use or disclosure of a trade secret contrary to honest commercial practices was carried out, in accordance with its laws and regulations: (a) to reveal misconduct, wrongdoing or illegal activity for the purpose of protecting the general public interest; (b) as a disclosure by employees to their representatives as part of, and necessary for, the legitimate exercise by those representatives of their functions; (c) to protect a legitimate interest recognised by the laws and regulations of that Party. SECTION 4 BORDER ENFORCEMENT Article 271 Border measures 1. With respect to goods under customs control, each Party shall adopt or maintain procedures under which a right holder may submit applications to a competent authority (40) to suspend the release of or detain suspected goods. For the purposes of this Section, \"suspected goods\" means goods suspected of infringing trade marks, copyrights and related rights, geographical indications, patents, utility models, industrial designs, topographies of integrated circuits and plant variety rights. 2. Each Party shall have in place electronic systems for the management by customs of the applications granted or recorded. 3. Each Party shall ensure that its competent authorities do not charge a fee to cover the administrative costs resulting from the processing of an application or a recordation. 4. Each Party shall ensure that its competent authorities decide about granting or recording applications within a reasonable period of time. 5. Each Party shall provide for the applications referred to in paragraph 1 to apply to multiple shipments. 6. With respect to goods under customs control, each Party shall ensure that its customs authorities may act upon their own initiative to suspend the release of or detain suspected goods. 7. Each Party shall ensure that its customs authorities use risk analysis to identify suspected goods. 8. Each Party may authorise its customs authority to provide a right holder, upon request, with information about goods, including a description and the actual or estimated quantities thereof, and if known, the name and address of the consignor, importer, exporter or consignee, and the country of origin or provenance of the goods, whose release has been suspended, or which have been detained. 9. Each Party shall have in place procedures allowing for the destruction of suspected goods, without there being any need for prior administrative or judicial proceedings for the formal determination of the infringements, where the persons concerned agree or do not oppose the destruction. In case suspected goods are not destroyed, each Party shall ensure that, except in exceptional circumstances, such goods are disposed of outside the commercial channel in a manner which avoids any harm to the right holder. 10. Each Party shall have in place procedures allowing for the swift destruction of counterfeit trade mark and pirated goods sent in postal or express couriers' consignments. 11. Each Party shall provide that, where requested by the customs authorities, the holder of the granted or recorded application shall be obliged to reimburse the costs incurred by the customs authorities, or other parties acting on behalf of customs authorities, from the moment of detention or suspension of the release of the goods, including storage, handling, and any costs relating to the destruction or disposal of the goods. 12. Each Party may decide not to apply this Article to the import of goods put on the market in another country by or with the consent of the right holders. A Party may exclude from the application of this Article goods of a non-commercial nature contained in travellers' personal luggage. 13. Each Party shall allow its customs authorities to maintain a regular dialogue and promote cooperation with the relevant stakeholders and with other authorities involved in the enforcement of intellectual property rights. 14. The Parties shall cooperate in respect of international trade in suspected goods. In particular, the Parties shall, as far as possible, share relevant information on trade in suspected goods affecting the other Party. 15. Without prejudice to other forms of cooperation, the Protocol on mutual administrative assistance in customs matters applies with regard to breaches of legislation on intellectual property rights for the enforcement of which the customs authorities of a Party are competent in accordance with this Article. Article 272 Consistency with GATT 1994 and the TRIPS Agreement In implementing border measures for the enforcement of intellectual property rights by customs, whether or not covered by this Section, the Parties shall ensure consistency with their obligations under GATT 1994 and the TRIPS Agreement and, in particular, with Article V of GATT 1994 and Article 41 and Section 4 of Part III of the TRIPS Agreement. CHAPTER 4 OTHER PROVISIONS Article 273 Cooperation 1. The Parties shall cooperate with a view to supporting the implementation of the commitments and obligations undertaken under this Title. 2. The areas of cooperation include, but are not limited to, the following activities: (a) exchange of information on the legal framework concerning intellectual property rights and relevant rules of protection and enforcement; (b) exchange of experience on legislative progress, on the enforcement of intellectual property rights and on enforcement at central and sub-central level by customs, police, administrative and judiciary bodies; (c) coordination to prevent exports of counterfeit goods, including coordination with other countries; (d) technical assistance, capacity building, exchange and training of personnel; (e) protection and defence of intellectual property rights and the dissemination of information in this regard in, among others, to business circles and civil society; (f) public awareness of consumers and right holders; (g) the enhancement of institutional cooperation, particularly between the intellectual property offices of the Parties; (h) educating and promoting awareness among the general public regarding policies concerning the protection and enforcement of intellectual property rights; (i) the promotion of protection and enforcement of intellectual property rights with public-private collaboration involving small and medium-size enterprises; (j) the formulation of effective strategies to identify audiences and communication programmes to increase consumer and media awareness of the impact of intellectual property rights' violations, including the risk to health and safety and the connection to organised crime. 3. The Parties shall, either directly or through the Trade Specialised Committee on Intellectual Property, maintain contact on all matters related to the implementation and functioning of this Title. Article 274 Voluntary stakeholder initiatives Each Party shall endeavour to facilitate voluntary stakeholder initiatives to reduce intellectual property rights infringement, including online and in other marketplaces focusing on concrete problems and seeking practical solutions that are realistic, balanced, proportionate and fair for all concerned including in the following ways: (a) each Party shall endeavour to convene stakeholders consensually in its territory to facilitate voluntary initiatives to find solutions and resolve differences regarding the protection and enforcement of intellectual property rights and reducing infringement; (b) the Parties shall endeavour to exchange information with each other regarding efforts to facilitate voluntary stakeholder initiatives in their respective territories; and (c) the Parties shall endeavour to promote open dialogue and cooperation among the Parties' stakeholders, and to encourage the Parties' stakeholders to jointly find solutions and resolve differences regarding the protection and enforcement of intellectual property rights and reducing infringement. Article 275 Review in relation to geographical indications Noting the relevant provisions of any earlier bilateral agreement between the United Kingdom of the one part and the European Union and European Atomic Energy Community of the other part, the Parties may jointly use reasonable endeavours to agree rules for the protection and effective domestic enforcement of their geographical indications. TITLE VI PUBLIC PROCUREMENT CHAPTER 1 SCOPE Article 276 Objective The objective of this Title is to guarantee each Party's suppliers access to increased opportunities to participate in public procurement procedures and to enhance the transparency of public procurement procedures. Article 277 Incorporation of certain provisions of the GPA and covered procurement 1. The provisions of the GPA that are specified in Section A of Annex 25, including the Annexes of each Party to Appendix I to the GPA, are hereby incorporated into this Title. 2. For the purposes of this Title, \"covered procurement\" means procurement to which Article II of the GPA applies and, in addition, procurement listed in Section B of Annex 25. 3. With regard to covered procurement, each Party shall apply, mutatis mutandis, the provisions of the GPA specified in Section A of Annex 25 to suppliers, goods or services of the other Party. CHAPTER 2 ADDITIONAL RULES FOR COVERED PROCUREMENT Article 278 Use of electronic means in procurement 1. Each Party shall ensure that its procuring entities conduct covered procurement by electronic means to the widest extent practicable. 2. A procuring entity is considered as conducting covered procurement by electronic means, if the entity uses electronic means of information and communication for: (a) the publication of notices and tender documentation in procurement procedures; and (b) the submission of requests to participate and of tenders. 3. Except for specific situations, such electronic means of information and communication shall be non-discriminatory, generally available and interoperable with the information and communication technology products in general use and shall not restrict access to the procurement procedure. 4. Each Party shall ensure that its procuring entities receive and process electronic invoices in accordance with its legislation. Article 279 Electronic publication With regard to covered procurement, all procurement notices including notices of intended procurement, summary notices, notices of planned procurement and contract award notices shall be directly accessible by electronic means, free of charge, through a single point of access on the internet. Article 280 Supporting evidence Each Party shall ensure that at the time of submission of requests to participate or at the time of submission of tenders, procuring entities do not require suppliers to submit all or part of the supporting evidence that they are not in one of the situations in which a supplier may be excluded and that they fulfil the conditions for participation unless this is necessary to ensure the proper conduct of the procurement. Article 281 Conditions for participation Each Party shall ensure that where its procuring entities require a supplier, as a condition for participation in a covered procurement, to demonstrate prior experience they do not require that the supplier has such experience in the territory of that Party. Article 282 Registration systems and qualification procedures A Party that maintains a supplier registration system shall ensure that interested suppliers may request registration at any time. Any interested supplier having made a request shall be informed within a reasonable period of time of the decision to grant or reject this request. Article 283 Selective tendering Each Party shall ensure that where a procuring entity uses a selective tendering procedure, the procuring entity addresses invitations to submit a tender to a number of suppliers that is sufficient to ensure genuine competition without affecting the operational efficiency of the procurement system. Article 284 Abnormally low prices Further to paragraph 6 of Article XV of the GPA, if a procuring entity receives a tender with a price that is abnormally lower than the prices in other tenders submitted, it may also verify with the supplier whether the price takes into account the grant of subsidies. Article 285 Environmental, social and labour considerations Each Party shall ensure that its procuring entities may take into account environmental, labour and social considerations throughout the procurement procedure, provided that those considerations are compatible with the rules established by Chapters 1 and 2 and are indicated in the notice of intended procurement or in another notice used as a notice of intended procurement or tender documentation. Article 286 Domestic review procedures 1. Where an impartial administrative authority is designated by a Party under paragraph 4 of Article XVIII of the GPA, that Party shall ensure that: (a) the members of the designated authority are independent, impartial, and free from external influence during the term of appointment; (b) the members of the designated authority are not dismissed against their will while they are in office, unless their dismissal is required by the provisions governing the designated authority; and (c) the President or at least one other member of the designated authority, has legal and professional qualifications equivalent to those necessary for judges, lawyers or other legal experts qualified under the laws and regulations of the Party. 2. Each Party shall adopt or maintain procedures that provide for rapid interim measures to preserve the supplier's opportunity to participate in the procurement. Such interim measures, provided for in subparagraph 7(a) of Article XVIII of the GPA, may result in suspension of the procurement process or, if a contract has been concluded by the procuring entity and if a Party has so provided, in suspension of performance of the contract. The procedures may provide that overriding adverse consequences for the interests concerned, including the public interest, may be taken into account when deciding whether such measures should be applied. Just cause for not acting shall be provided in writing. 3. In case an interested or participating supplier has submitted a challenge with the designated authority referred to in paragraph 1, each Party shall, in principle, ensure that a procuring entity shall not conclude the contract until that authority has made a decision or recommendation on the challenge with regard to interim measures, corrective action or compensation for the loss or damages suffered as referred to in paragraphs 2, 5 and 6 in accordance with its rules, regulations and procedures. Each Party may provide that in unavoidable and duly justified circumstances, the contract can be nevertheless concluded. 4. Each Party may provide for: (a) a standstill period between the contract award decision and the conclusion of a contract in order to give sufficient time to unsuccessful suppliers to assess whether it is appropriate to initiate a review procedure; or (b) a sufficient period for an interested supplier to submit a challenge, which may constitute grounds for the suspension of the execution of a contract. 5. Corrective action under subparagraph 7(b) of Article XVIII of the GPA may include one or more of the following: (a) the removal of discriminatory technical, economic or financial specifications in the invitation to tender, the contract documents or any other document relating to the tendering procedure and conduct of new procurement procedures; (b) the repetition of the procurement procedure without changing the conditions; (c) the setting aside of the contract award decision and the adoption of a new contract award decision; (d) the termination of a contract or the declaration of its ineffectiveness; or (e) the adoption of other measures with the aim to remedy a breach of Chapters 1 and 2, for example an order to pay a particular sum until the breach has been effectively remedied. 6. In accordance with subparagraph 7(b) of Article XVIII of the GPA, each Party may provide for the award of compensation for the loss or damages suffered. In this regard, if the review body of the Party is not a court and a supplier believes that there has been a breach of the domestic laws and regulations implementing the obligations under Chapters 1 and 2 of this Title, the supplier may bring the matter before a court, including with a view to seeking compensation, in accordance with judicial procedures of the Party. 7. Each Party shall adopt or maintain the necessary procedures by which the decisions or recommendations made by review bodies are effectively implemented, or the decisions by judicial review bodies are effectively enforced. CHAPTER 3 NATIONAL TREATMENT BEYOND COVERED PROCUREMENT Article 287 Definitions 1. For the purposes of this Chapter, the treatment accorded by a Party under this Chapter means: (a) with respect to the United Kingdom, treatment no less favourable than the most favourable treatment accorded, in like situations, to suppliers of the United Kingdom; and (b) with respect to a Member State, treatment no less favourable than the most favourable treatment accorded, in like situations, within that Member State to suppliers of that Member State. 2. For the purposes of this Chapter, a supplier of a Party, which is a legal person means: (a) for the Union, a legal person constituted or organised under the law of the Union or at least one of its Member States and engaged in substantive business operations, understood by the Union, in line with its notification of the Treaty establishing the European Community to the WTO (WT/REG39/1), as equivalent to the concept of \"effective and continuous link\" with the economy of a Member State enshrined in Article 54 of the TFEU, in the territory of the Union; and (b) for the United Kingdom, a legal person constituted or organised under the law of the United Kingdom and engaged in substantive business operations in the territory of the United Kingdom. Article 288 National treatment of locally established suppliers 1. With regard to any procurement, a measure of a Party shall not result for suppliers of the other Party established in its territory through the constitution, acquisition or maintenance of a legal person in treatment less favourable than that Party accords to its own like suppliers (41). 2. The application of the national treatment obligation provided for in this Article remains subject to security and general exceptions as defined in Article III of the GPA, even if the procurement is not covered procurement in accordance with this Title. CHAPTER 4 OTHER PROVISIONS Article 289 Modifications and rectifications of market access commitments Each Party may modify or rectify its market access commitments in its respective Sub-section under Section B of Annex 25 in accordance with the procedures set out in Articles 290 to 293. Article 290 Modifications 1. A Party intending to modify a Sub-section of Section B of Annex 25, shall: (a) notify the other Party in writing; and (b) include in the notification a proposal for appropriate compensatory adjustments to the other Party to maintain a level of market access commitments comparable to that existing prior to the modification. 2. Notwithstanding point (b) of paragraph 1, a Party is not required to provide compensatory adjustments to the other Party if the proposed modification covers a procuring entity over which the Party has effectively eliminated its control or influence in respect of covered procurement. A Party's control or influence over the covered procurement of procuring entities is presumed to be effectively eliminated if the procuring entity is exposed to competition in markets to which access is not restricted. 3. The other Party may object to the modification referred to in point (a) of paragraph 1 if it disputes that: (a) a compensatory adjustment proposed under point (b) of paragraph 1 is adequate to maintain a comparable level of mutually agreed market access commitments; or (b) the modification covers a procuring entity over which the Party has effectively eliminated its control or influence as provided for in paragraph 2. The other Party shall object in writing within 45 days of receipt of the notification referred to in point (a) of paragraph 1 or be deemed to have accepted the compensatory adjustment or modification, including for the purposes of Title I of Part Six. Article 291 Rectifications 1. A Party intending to rectify a Sub-section under Section B of Annex 25 shall notify the other Party in writing. The following changes to a Sub-section under Section B of Annex 25 shall be considered a rectification, provided that they do not affect the mutually agreed market access commitments provided for in this Title: (a) a change in the name of a procuring entity; (b) a merger of two or more procuring entities listed within that Sub-section; and (c) the separation of a procuring entity listed in that Sub-section into two or more procuring entities that are added to the procuring entities listed in the same Sub-section. 2. A Party may notify the other Party of an objection to a proposed rectification within 45 days from having received the notification. A Party submitting an objection shall set out the reasons for considering the proposed rectification not as a change provided for in paragraph 1, and describe the effect of the proposed rectification on the mutually agreed market access commitments provided for in this Title. If no such objection is submitted in writing within 45 days after having received the notification, the Party shall be deemed to have agreed to the proposed rectification. Article 292 Consultations and dispute resolution If a Party objects to the proposed modification or the proposed compensatory adjustments referred to in Article 290 or to the proposed rectification referred to in Article 291, the Parties shall seek to resolve the issue through consultations. If no agreement is found within 60 days of receipt of the objection, the Party seeking to modify or rectify its Sub-section under Section B of Annex 25 may refer the matter to dispute settlement in accordance with Title I of Part Six, to determine whether the objection is justified. Article 293 Amendment of Section B of Annex 25 If a Party does not object to the modification pursuant to Article 290(3) or to a rectification pursuant to Article 291(2), or the modifications or rectifications are agreed between the Parties through the consultations referred to in Article 292, or there is a final settlement of the matter under Title I of Part Six, the Partnership Council shall amend the relevant Sub-section under Section B of Annex 25 to reflect the corresponding modifications or rectifications or the compensatory adjustments. Article 294 Cooperation 1. The Parties recognise the benefits that may arise from cooperating in the international promotion of the mutual liberalisation of public procurement markets. 2. The Parties shall make available to each other annual statistics on covered procurement subject to technical availability. TITLE VII SMALL AND MEDIUM-SIZED ENTERPRISES Article 295 Objective The objective of this Title is to enhance the ability of small and medium-sized enterprises to benefit from this Heading. Article 296 Information sharing 1. Each Party shall establish or maintain its own publicly accessible website for small and medium-sized enterprises with information regarding this Heading, including: (a) a summary of this Heading; (b) a description of the provisions in this Heading that each Party considers to be relevant to small and medium-sized enterprises of both Parties; and (c) any additional information that each Party considers would be useful for small and medium-sized enterprises interested in benefitting from this Heading. 2. Each Party shall include an internet link in the website provided for in paragraph 1 to the: (a) text of this Heading; (b) equivalent website of the other Party; and (c) websites of its own authorities that the Party considers would provide useful information to persons interested in trading and doing business in its territory. 3. Each Party shall include an internet link in the website referred to in paragraph 1 to websites of its own authorities with information related to the following: (a) customs laws and regulations, procedures for importation, exportation and transit as well as relevant forms, documents and other information required; (b) laws, regulations and procedures concerning intellectual property rights, including geographical indications; (c) technical laws and regulations including, where necessary, obligatory conformity assessment procedures and links to lists of conformity assessment bodies, in cases where third party conformity assessment is obligatory, as provided for in Chapter 4 of Title I; (d) laws and regulations on sanitary and phytosanitary measures relating to importation and exportation as provided for in Chapter 3 of Title I; (e) laws and regulations on public procurement, single point of access on the internet to public procurement notices as provided for in Title VI and other relevant provisions contained in that Title; (f) company registration procedures; and (g) other information which the Party considers may be of assistance to small and medium-sized enterprises. 4. Each Party shall include an internet link in the website provided for in paragraph 1 to a database that is electronically searchable by tariff nomenclature code and that includes the following information with respect to access to its market: (a) in respect of tariff measures and tariff-related information: (i) rates of customs duties and quotas, including most-favoured nation, rates concerning non most-favoured nation countries and preferential rates and tariff rate quotas; (ii) excise duties; (iii) taxes (value added tax/ sales tax); (iv) customs or other fees, including other product specific fees; (v) rules of origin as provided for in Chapter 2 of Title I; (vi) duty drawback, deferral, or other types of relief that reduce, refund, or waive customs duties; (vii) criteria used to determine the customs value of the good; and (viii) other tariff measures; (b) in respect of tariff nomenclature related non-tariff measures: (i) information needed for import procedures; and (ii) information related to non-tariff measures. 5. Each Party shall regularly, or if requested by the other Party, update the information and links referred to in paragraphs 1 to 4 that it maintains on its website to ensure such information and links are up-to-date and accurate. 6. Each Party shall ensure that the information and links referred to in paragraphs 1 to 4 is presented in an adequate manner to use for small and medium-sized enterprises. Each Party shall endeavour to make the information available in English. 7. No fee shall apply for access to the information provided pursuant to paragraphs 1 to 4 for any person of either Party. Article 297 Small and medium-sized enterprises contact points 1. Upon the entry into force of this Agreement, each Party shall designate a contact point to carry out the functions listed in this Article and notify the other Party of its contact details. The Parties shall promptly notify each other of any change of those contact details. 2. The small and medium-sized enterprises contact points of the Parties shall: (a) seek to ensure that the needs of small and medium-sized enterprises are taken into account in the implementation of this Heading and that small and medium-sized enterprises of both Parties can take advantage of this Heading; (b) consider ways for strengthening the cooperation on matters of relevance to small and medium-sized enterprises between the Parties in view of increasing trade and investment opportunities for small and medium-sized enterprises; (c) ensure that the information referred to in Article 296 is up-to-date, accurate and relevant for small and medium-sized enterprises. Either Party may, through the small and medium-sized enterprises contact point, suggest additional information that the other Party may include in its websites to be maintained in accordance with Article 296; (d) examine any matter relevant to small and medium-sized enterprises in connection with the implementation of this Heading, including: (i) exchanging information to assist the Partnership Council in its task to monitor and implement the small and medium-sized enterprises-related aspects of this Heading; (ii) assisting specialised committees, joint working groups and contact points established by this Agreement in considering matters of relevance to small and medium-sized enterprises; (e) report periodically on their activities, jointly or individually, to the Partnership Council for its consideration; and (f) consider any other matter arising under this Agreement pertaining to small and medium-sized enterprises as the Parties may agree. 3. The small and medium-sized enterprises contact points of the Parties shall carry out their work through the communication channels decided by the Parties, which may include electronic mail, videoconferencing or other means. They may also meet, as appropriate. 4. Small and medium-sized enterprises contact points may seek to cooperate with experts and external organisations, as appropriate, in carrying out their activities. Article 298 Relation with Part Six Title I of Part Six does not apply to this Title. TITLE VIII ENERGY CHAPTER 1 GENERAL PROVISIONS Article 299 Objectives The objectives of this Title are to facilitate trade and investment between the Parties in the areas of energy and raw materials, and to support security of supply and environmental sustainability, notably in contributing to the fight against climate change in those areas. Article 300 Definitions 1. For the purposes of this Title, the following definitions apply: (a) \"Agency for the Cooperation of Energy Regulators\" means the Agency established by Regulation (EU) 2019/942 of the European Parliament and of the Council (42); (b) \"authorisation\" means the permission, licence, concession or similar administrative or contractual instrument by which the competent authority of a Party entitles an entity to exercise a certain economic activity in its territory; (c) \"balancing\" means: (i) for electricity systems, all actions and processes, in all timelines, through which electricity transmission system operators ensure, in an ongoing manner, maintenance of the system frequency within a predefined stability range and compliance with the amount of reserves needed with respect to the required quality; (ii) for gas systems, actions undertaken by gas transmission system operators to change the gas flows onto or off the transmission network, excluding those actions related to gas unaccounted for as off-taken from the system and gas used by the transmission system operator for the operation of the system; (d) \"distribution\" means: (i) in relation to electricity, the transport of electricity on high-voltage, medium-voltage and low-voltage distribution systems with a view to its delivery to customers, but does not include supply; (ii) in relation to gas, the transport of natural gas through local or regional pipeline networks with a view to its delivery to customers, but does not include supply; (e) \"distribution system operator\" means a natural or legal person who is responsible for operating, ensuring the maintenance of, and, if necessary, developing the electricity or gas distribution system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the distribution of electricity or gas; (f) \"electricity interconnector\" means a transmission line: (i) between the Parties, excluding any such line wholly within the single electricity market in Ireland and Northern Ireland; (ii) between Great Britain and the single electricity market in Ireland and Northern Ireland that is outside the scope of point (i); (g) \"energy goods\" means the goods from which energy is generated, listed by the corresponding Harmonised System (HS) code in Annex 26; (h) \"entity\" means any natural person, legal person or enterprise or group thereof; (i) \"gas interconnector\" means a transmission line which crosses or spans the border between the Parties; (j) \"generation\" means the production of electricity; (k) \"hydrocarbons\" means the goods listed by the corresponding HS code in Annex 26; (l) \"interconnection point\" means, in relation to gas, a physical or virtual point connecting Union and United Kingdom entry-exit systems or connecting an entry-exit system with an interconnector, in so far as these points are subject to booking procedures by network users; (m) \"raw materials\" means the goods listed by the corresponding HS chapter in Annex 26; (n) \"renewable energy\" means a type of energy, including electrical energy, produced from renewable non-fossil sources; (o) \"standard capacity product\" means, in relation to gas, a certain amount of transport capacity over a given period of time, at a specific interconnection point; (p) \"transmission\" means: (i) in relation to electricity, the transport of electricity on the extra high-voltage and high-voltage system with a view to its delivery to customers or to distributors, but does not include supply; (ii) in relation to gas, the transport of natural gas through a network, which mainly contains high-pressure pipelines, other than an upstream pipeline network and other than the part of high-pressure pipelines primarily used in the context of local distribution of natural gas, with a view to its delivery to customers, but not including supply; (q) \"transmission system operator\" means a natural or legal person who carries out the function of transmission or is responsible for operating, ensuring the maintenance of, and, if necessary, developing the electricity or gas transmission system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the transport of gas or electricity, as the case may be; (r) \"upstream pipeline network\" means any pipeline or network of pipelines operated or constructed as part of an oil or gas production project, or used to convey natural gas from one or more such projects to a processing plant or terminal or final coastal landing terminal. 2. For the purposes of this Title, references to \"non-discriminatory\" and \"non-discrimination\" mean most-favoured-nation treatment as defined in Articles 130 and 138 and national treatment as defined in Articles 129 and 137, as well as treatment under terms and conditions no less favourable than that accorded to any other like entity in like situations. Article 301 Relationship with other Titles 1. Chapter 2 and Chapter 3 of Title II of this Heading apply to energy and raw materials. In the event of any inconsistency between this Title and Title II of this Heading and Annexes 19 to 24, Title II of this Heading and Annexes 19 to 24 shall prevail. 2. For the purposes of Article 20 where a Party maintains or implements a system of virtual trading of natural gas or electricity using pipelines or electricity grids, meaning a system which does not require physical identification of the transited natural gas or electricity but is based on a system of netting inputs and outputs, the routes most convenient for international transit as referred to in that Article shall be deemed to include such virtual trading. 3. When applying Chapter 3 of Title XI of this Heading, Annex 27 also applies. Chapter 3 of Title XI of this Heading applies to Annex 27. Article 375 applies to disputes arising between the Parties concerning the interpretation and application of Annex 27. Article 302 Principles Each Party preserves the right to adopt, maintain and enforce measures necessary to pursue legitimate public policy objectives, such as securing the supply of energy goods and raw materials, protecting society, the environment, including fighting against climate change, public health and consumers and promoting security and safety, consistent with the provisions of this Agreement. CHAPTER 2 ELECTRICITY AND GAS SECTION 1 COMPETITION IN ELECTRICITY AND GAS MARKETS Article 303 Competition in markets and non-discrimination 1. With the objective of ensuring fair competition, each Party shall ensure that its regulatory framework for the production, generation, transmission, distribution or supply of electricity or natural gas is non-discriminatory with regard to rules, fees and treatment. 2. Each Party shall ensure that customers are free to choose, or switch to, the electricity or natural gas supplier of their choice within their respective retail markets in accordance with the applicable laws and regulations. 3. Without prejudice to the right of each Party to define quality requirements, the provisions in this Chapter related to natural gas also apply to biogas and gas from biomass or other types of gas in so far as such gas can technically and safely be injected into, and transported through, the natural gas system. 4. This Article does not apply to cross-border trade and is without prejudice to each Party's right to regulate in order to achieve legitimate public policy goals based on objective and non-discriminatory criteria. Article 304 Provisions relating to wholesale electricity and gas markets 1. Each Party shall ensure that wholesale electricity and natural gas prices reflect actual supply and demand. To that end, each Party shall ensure that wholesale electricity and natural gas market rules: (a) encourage free price formation; (b) do not set any technical limits on pricing that restrict trade; (c) enable the efficient dispatch of electricity generation assets, energy storage and demand response and the efficient use of the electricity system; (d) enable the efficient use of the natural gas system; and (e) enable the integration of electricity from renewable energy sources, and ensure the efficient and secure operation and development of the electricity system. 2. Each Party shall ensure that balancing markets are organised in such a way as to ensure: (a) non-discrimination between participants and non-discriminatory access to participants; (b) that services are defined in a transparent manner; (c) that services are procured in a transparent, market-based manner, taking account of the advent of new technologies; and (d) that producers of renewable energy are accorded reasonable and non-discriminatory terms when procuring products and services. A Party may decide not to apply point (c) if there is a lack of competition in the market for balancing services. 3. Each Party shall ensure that any capacity mechanism in electricity markets is clearly defined, transparent, proportionate and non-discriminatory. Neither Party is required to permit capacity situated in the territory of the other Party to participate in any capacity mechanism in its electricity markets. 4. Each Party shall assess the necessary actions to facilitate the integration of gas from renewable sources. 5. This Article is without prejudice to each Party's right to regulate in order to achieve legitimate public policy goals based on objective and non-discriminatory criteria. Article 305 Prohibition of market abuse on wholesale electricity and gas markets 1. Each Party shall prohibit market manipulation and insider trading on wholesale electricity and natural gas markets, including over-the-counter markets, electricity and natural gas exchanges and markets for the trading of electricity and natural gas, capacity, balancing and ancillary services in all timeframes, including forward, day-ahead and intraday markets. 2. Each Party shall monitor trading activity on these markets with a view to detecting and preventing trading based on inside information and market manipulation. 3. The Parties shall cooperate, including in accordance with Article 318, with a view to detecting and preventing trading based on inside information and market manipulation and, where appropriate, may exchange information including on market monitoring and enforcement activities. Article 306 Third-party access to transmission and distribution networks 1. Each Party shall ensure the implementation of a system of third-party access to their transmission and distribution networks based on published tariffs that are applied objectively and in a non-discriminatory manner. 2. Without prejudice to Article 302, each Party shall ensure that transmission and distribution system operators in its territory grant access to their transmission or distribution systems to entities in that Party's market within a reasonable period of time from the date of the request for access. Each Party shall ensure that transmission system operators treat producers of renewable energy on reasonable and non-discriminatory terms regarding connection to, and use of, the electricity network. The transmission or distribution system operator may refuse access where it lacks the necessary capacity. Duly substantiated reasons shall be given for any such refusal. 3. Without prejudice to legitimate public policy objectives, each Party shall ensure that charges applied to entities in that Party's market by transmission and distribution system operators for access to, connection to or the use of networks, and, where applicable, charges for related network reinforcements, are appropriately cost-reflective and transparent. Each Party shall ensure publication of the terms, conditions, tariffs and all such information that may be necessary for the effective exercise of the right of access to and use of transmission and distribution systems. 4. Each Party shall ensure that the tariffs and charges referred to in paragraphs 1 and 3 are applied in a non-discriminatory manner with respect to entities in that Party's market. Article 307 System operation and unbundling of transmission network operators 1. Each Party shall ensure that transmission system operators carry out their functions in a transparent, non-discriminatory way. 2. Each Party shall implement arrangements for transmission system operators which are effective in removing any conflicts of interest arising as a result of the same person exercising control over a transmission system operator and a producer or supplier. Article 308 Public policy objectives for third-party access and ownership unbundling 1. Where necessary to fulfil a legitimate public policy objective and based on objective criteria, a Party may decide not to apply Articles 306 and 307 to the following: (a) emergent or isolated markets or systems; (b) infrastructure which meets the conditions set out in Annex 28. 2. Where necessary to fulfil a legitimate public policy objective and based on objective criteria, a Party may decide not to apply Articles 303 and 304 to: (a) small or isolated electricity markets or systems; (b) small, emergent or isolated natural gas markets or systems. Article 309 Existing exemptions for interconnectors Each Party shall ensure that exemptions granted to interconnections between the Union and the United Kingdom under Article 63 of Regulation (EU) 2019/943 of the European Parliament and of the Council (43) and under the law transposing Article 36 of Directive 2009/73/EC of the European Parliament and of the Council (44) in their respective jurisdictions, the terms of which extend beyond the transition period, continue to apply in accordance with the laws of their respective jurisdictions and the terms applicable. Article 310 Independent regulatory authority 1. Each Party shall ensure the designation and maintenance of an operationally independent regulatory authority or authorities for electricity and gas with the following powers and duties: (a) fixing or approving the tariffs, charges and conditions for access to networks referred to in Article 306, or the methodologies underlying them; (b) ensuring compliance with the arrangements referred to in Articles 307 and 308; (c) issuing binding decisions at least in relation to points (a) and (b); (d) imposing effective remedies. 2. In performing those duties and exercising those powers, the independent regulatory authority or authorities shall act impartially and transparently. SECTION 2 TRADING OVER INTERCONNECTORS Article 311 Efficient use of electricity interconnectors 1. With the aim of ensuring the efficient use of electricity interconnectors and reducing barriers to trade between the Union and the United Kingdom, each Party shall ensure that: (a) capacity allocation and congestion management on electricity interconnectors is market based, transparent and non-discriminatory; (b) the maximum level of capacity of electricity interconnectors is made available, respecting the: (i) need to ensure secure system operation; and (ii) most efficient use of systems; (c) electricity interconnector capacity may only be curtailed in emergency situations and any such curtailment takes place in a non-discriminatory manner; (d) information on capacity calculation is published to support the objectives of this Article; (e) there are no network charges on individual transactions on, and no reserve prices for the use of, electricity interconnectors; (f) capacity allocation and congestion management across electricity interconnectors is coordinated between concerned Union transmission system operators and United Kingdom transmission system operators; this coordination shall involve the development of arrangements to deliver robust and efficient outcomes for all relevant timeframes, being forward, day-ahead, intraday and balancing; and (g) capacity allocation and congestion management arrangements contribute to supportive conditions for the development of, and investment in, economically efficient electricity interconnection. 2. The coordination and arrangements referred to in point (f) of paragraph 1 shall not involve or imply participation by United Kingdom transmission system operators in Union procedures for capacity allocation and congestion management. 3. Each Party shall take the necessary steps to ensure the conclusion as soon as possible of a multi-party agreement relating to the compensation for the costs of hosting cross-border flows of electricity between: (a) transmission system operators participating in the inter-transmission system operator compensation mechanism established by Commission Regulation (EU) No 838/2010 (45); and (b) United Kingdom transmission system operators. 4. The multi-party agreement referred to in paragraph 3 shall aim to ensure: (a) that United Kingdom transmission system operators are treated on an equivalent basis to a transmission system operator in a country participating in the inter-transmission system operator compensation mechanism; and (b) the treatment of United Kingdom transmission system operators is not more favourable in comparison to that which would apply to a transmission system operator participating in the inter-transmission system operator compensation mechanism. 5. Notwithstanding point (e) of paragraph 1, until such time as the multi-party agreement referred to in paragraph 3 has been concluded, a transmission system use fee may be levied on scheduled imports and exports between the Union and the United Kingdom. Article 312 Electricity trading arrangements at all timeframes 1. For capacity allocation and congestion management at the day ahead stage, the Specialised Committee on Energy, as a matter of priority, shall take the necessary steps in accordance with Article 317 to ensure that transmission system operators develop arrangements setting out technical procedures in accordance with Annex 29 within a specific timeline. 2. If the Specialised Committee on Energy does not recommend that the Parties implement such technical procedures in accordance with Article 317(4), it shall take decisions and make recommendations as necessary for electricity interconnector capacity to be allocated at the day-ahead market timeframe in accordance with Annex 29. 3. The Specialised Committee on Energy shall keep under review the arrangements for all timeframes, and for balancing and intraday timeframes in particular, and may recommend that each Party requests its transmission system operators to prepare technical procedures in accordance with Article 317 to improve arrangements for a particular timeframe. 4. The Specialised Committee on Energy shall keep under review whether the technical procedures developed in accordance with paragraph 1 continue to meet the requirements of Annex 29, and shall promptly address any issues that are identified. Article 313 Efficient use of gas interconnectors 1. With the aim of ensuring the efficient use of gas interconnectors and reducing barriers to trade between the Union and the United Kingdom, each Party shall ensure that: (a) the maximum level of capacity of gas interconnectors is made available, respecting the principle of non-discrimination and taking account of: (i) the need to ensure secure system operation; and (ii) the most efficient use of systems; (b) capacity allocation mechanisms and congestion management procedures for gas interconnectors are market-based, transparent and non-discriminatory, and that auctions are generally used for the allocation of capacity at interconnection points. 2. Each Party shall take the necessary steps to ensure that: (a) transmission system operators endeavour to offer jointly standard capacity products which consist of corresponding entry and exit capacity at both sides of an interconnection point; (b) transmission system operators coordinate procedures relating to the use of gas interconnectors between Union transmission system operators and United Kingdom transmission system operators concerned. 3. The coordination referred to in point (b) of paragraph 2 shall not involve or imply participation by United Kingdom transmission system operators in Union procedures relating to the use of gas interconnectors. SECTION 3 NETWORK DEVELOPMENT AND SECURITY OF SUPPLY Article 314 Network development 1. The Parties shall cooperate to facilitate the timely development and interoperability of energy infrastructure connecting their territories. 2. Each Party shall ensure that network development plans for electricity and gas transmission systems are drawn up, published and regularly updated. Article 315 Cooperation on security of supply 1. The Parties shall cooperate with respect to the security of supply of electricity and natural gas. 2. The Parties shall exchange information on any risks identified pursuant to Article 316 in a timely manner. 3. The Parties shall share the plans referred to in Article 316. For the Union, these plans may be at Member State or regional level. 4. The Parties shall inform each other without undue delay where there is reliable information that a disruption or other crisis relating to the supply of electricity or natural gas may occur and on measures planned or taken. 5. The Parties shall immediately inform each other in the event of an actual disruption or other crisis, in view of possible coordinated mitigation and restoration measures. 6. The Parties shall share best practices regarding short-term and seasonal adequacy assessments. 7. The Parties shall develop appropriate frameworks for cooperation with respect to the security of supply of electricity and natural gas. Article 316 Risk preparedness and emergency plans 1. Each Party shall assess risks affecting the security of supply of electricity or natural gas, including the likelihood and impact of such risks, and including cross-border risks. 2. Each Party shall establish and regularly update plans to address identified risks affecting the security of supply of electricity or natural gas. Such plans shall contain the measures needed to remove or mitigate the likelihood and impact of any risk identified under paragraph 1 and the measures needed to prepare for, and mitigate the impact of, an electricity or natural gas crisis. 3. The measures contained in the plans referred to in paragraph 2 shall: (a) be clearly defined, transparent, proportionate, non-discriminatory and verifiable; (b) not significantly distort trade between the Parties; and (c) not endanger the security of supply of electricity or natural gas of the other Party. In the event of a crisis, the Parties shall only activate non-market based measures as a last resort. SECTION 4 TECHNICAL COOPERATION Article 317 Cooperation between transmission system operators 1. Each Party shall ensure that transmission system operators develop working arrangements that are efficient and inclusive in order to support the planning and operational tasks associated with meeting the objectives of this Title, including, when recommended by the Specialised Committee on Energy, the preparation of technical procedures to implement effectively the provisions of Articles 311 to 315. The working arrangements referred to in the first subparagraph shall include frameworks for cooperation between the European Network of Transmission System Operators for Electricity established in accordance with Regulation (EU) 2019/943 (\"ENTSO-E\") and the European Network of Transmission System Operators for Gas established in accordance with Regulation (EC) No 715/2009 of the European Parliament and of the Council (46) (\"ENTSOG\"), on the one side, and the transmission system operators for electricity and gas in the United Kingdom, on the other. Those frameworks shall cover at least the following areas: (a) electricity and gas markets; (b) access to networks; (c) the security of electricity and gas supply; (d) offshore energy; (e) infrastructure planning; (f) the efficient use of electricity and gas interconnectors; and (g) gas decarbonisation and gas quality. The Specialised Committee on Energy shall agree on guidance on the working arrangements and frameworks for cooperation for dissemination to transmission system operators as soon as practicable. The frameworks for cooperation mentioned in the second subparagraph shall not involve, or confer a status comparable to, membership in ENTSO-E or ENTSOG by United Kingdom transmission system operators. 2. The Specialised Committee on Energy may recommend that each Party requests its transmission system operators to prepare the technical procedures as referred to in the first subparagraph of paragraph 1. 3. Each Party shall ensure that its respective transmission system operators request the opinions of the Agency for the Cooperation of Energy Regulators and the regulatory authority in the United Kingdom designated in accordance with Article 310 on the technical procedures, respectively, in the event of a disagreement and in any event before the finalisation of those technical procedures. The Parties' respective transmission system operators shall submit those opinions together with the draft technical procedures to the Specialised Committee on Energy. 4. The Specialised Committee on Energy shall review the draft technical procedures, and may recommend that the Parties implement such procedures in their respective domestic arrangements, taking due account of the opinions of the Agency for the Cooperation of Energy Regulators and the regulatory authority in the United Kingdom designated in accordance with Article 310. The Specialised Committee on Energy shall monitor the effective operation of such technical procedures and may recommend that they be updated. Article 318 Cooperation between regulatory authorities 1. The Parties shall ensure that the Agency for the Cooperation of Energy Regulators and the regulatory authority in the United Kingdom designated in accordance with Article 310 develop contacts and enter into administrative arrangements as soon as possible in order to facilitate meeting the objectives of this Agreement. The contacts and administrative arrangements shall cover at least the following areas: (a) electricity and gas markets; (b) access to networks; (c) the prevention of market abuse on wholesale electricity and gas markets; (d) the security of electricity and gas supply; (e) infrastructure planning; (f) offshore energy; (g) the efficient use of electricity and gas interconnectors; (h) cooperation between transmission system operators; and (i) gas decarbonisation and gas quality. The Specialised Committee on Energy shall agree on guidance on the administrative arrangements for such cooperation for dissemination to regulatory authorities as soon as practicable. 2. The administrative arrangements referred to in paragraph 1 shall not involve, or confer a status comparable to, participation in the Agency for the Cooperation of Energy Regulators by the regulatory authority in the United Kingdom designated in accordance with Article 310. CHAPTER 3 SAFE AND SUSTAINABLE ENERGY Article 319 Renewable energy and energy efficiency 1. Each Party shall promote energy efficiency and the use of energy from renewable sources. Each Party shall ensure that its rules that apply to licencing or equivalent measures applicable to energy from renewable sources are necessary and proportionate. 2. The Union reaffirms the target for the share of gross final energy consumption from renewable energy sources in 2030 as set out in Directive (EU) 2018/2001 of the European Parliament and of the Council (47). The Union reaffirms its energy efficiency targets for 2030 as set out in the Directive 2012/27/EU of the European Parliament and of the Council (48). 3. The United Kingdom reaffirms: (a) its ambition for the share of energy from renewable sources in gross final energy consumption in 2030 as set out in its National Energy and Climate Plan; (b) its ambition for the absolute level of primary and final energy consumption in 2030 as set out in its National Energy and Climate Plan. 4. The Parties shall keep each other informed in relation to the matters referred to in paragraphs 2 and 3. Article 320 Support for renewable energy 1. Each Party shall ensure that support for electricity from renewable sources facilitates the integration of electricity from renewable sources in the electricity market. 2. Biofuels, bioliquids and biomass shall only be supported as renewable energy if they meet robust criteria for sustainability and greenhouse gas emissions saving, which are subject to verification. 3. Each Party shall clearly define any technical specifications which are to be met by renewable energy equipment and systems in order to benefit from support schemes. Such technical specifications shall take into account cooperation developed under Articles 91, 92 and 323. Article 321 Cooperation in the development of offshore renewable energy 1. The Parties shall cooperate in the development of offshore renewable energy by sharing best practices and, where appropriate, by facilitating the development of specific projects. 2. Building on the North Seas Energy Cooperation, the Parties shall enable the creation of a specific forum for technical discussions between the European Commission, ministries and public authorities of the Member States, United Kingdom ministries and public authorities, transmission system operators and the offshore energy industry and stakeholders more widely, in relation to offshore grid development and the large renewable energy potential of the North Seas region. That cooperation shall include at least the following areas: (a) hybrid and joint projects; (b) maritime spatial planning; (c) support framework and finance; (d) best practices on respective onshore and offshore grid planning; (e) the sharing of information on new technologies; and (f) the exchange of best practices in relation to the relevant rules, regulations and technical standards. Article 322 Offshore risk and safety 1. The Parties shall cooperate and exchange information with the aim of maintaining high levels of safety and environmental protection for all offshore oil and gas operations. 2. The Parties shall take appropriate measures to prevent major accidents from offshore oil and gas operations and to limit the consequences of such accidents. 3. The Parties shall promote the exchange of best practices among their authorities that are competent for the safety and environmental protection of offshore oil and gas operations. The regulation of the safety and environmental protection of offshore oil and gas operations shall be independent from any functions relating to licensing of offshore oil and gas operations. Article 323 Cooperation on standards In accordance with Articles 92 and 98, the Parties shall promote cooperation between the regulators and standardisation bodies located within their respective territories to facilitate the development of international standards with respect to energy efficiency and renewable energy, with a view to contributing to sustainable energy and climate policy. Article 324 Research, development and innovation The Parties shall promote research, development and innovation in the areas of energy efficiency and renewable energy. CHAPTER 4 ENERGY GOODS AND RAW MATERIALS Article 325 Export pricing A Party shall not impose a higher price for exports of energy goods or raw materials to the other Party than the price charged for those energy goods or raw materials when destined for the domestic market, by means of any measures such as licences or minimum price requirements. Article 326 Regulated pricing If a Party decides to regulate the price of the domestic supply to consumers of electricity or natural gas, it may do so only to achieve a public policy objective, and only by imposing a regulated price that is clearly defined, transparent, non-discriminatory and proportionate. Article 327 Authorisation for exploration and production of hydrocarbons and generation of electricity 1. If a Party requires an authorisation for exploration or production of hydrocarbons or generation of electricity, that Party shall grant such authorisations on the basis of objective and non-discriminatory criteria which are drawn up and published before the start of the period for submission of applications in accordance with the general conditions and procedures set out in Section 1 of Chapter 5 of Title II of this Heading. 2. Notwithstanding paragraph 1 of this Article and Article 301, each Party may grant authorisations related to exploration for or the production of hydrocarbons without complying with the conditions and procedures related to publication set out in Article 153 on the basis of duly justified exemptions as provided for in applicable legislation. 3. Financial contributions or contributions in kind required from entities to which an authorisation is granted shall not interfere with the management and decision-making process of such entities. 4. Each Party shall provide that an applicant for authorisation has the right to appeal any decision concerning the authorisation to an authority higher than or independent from the authority that issued the decision or to request that such a higher or independent authority review that decision. Each Party shall ensure that the applicant is provided with the reasons for the administrative decision to enable the applicant to have recourse to the procedures for appeal or review if necessary. The applicable rules for appeal or review shall be published. Article 328 Safety and integrity of energy equipment and infrastructure This Title shall not be construed as preventing a Party from adopting temporary measures necessary to protect the safety and preserve the integrity of energy equipment or infrastructure, provided that those measures are not applied in a manner which would constitute a disguised restriction on trade or investment between the Parties. CHAPTER 5 FINAL PROVISIONS Article 329 Effective implementation and amendments 1. The Partnership Council may amend Annex 26 and Annex 28. The Partnership Council may update Annex 27 as necessary to ensure the operation of that Annex over time. 2. The Specialised Committee on Energy may amend Annex 29. 3. The Specialised Committee on Energy shall make recommendations as necessary to ensure the effective implementation of the Chapters of this Title for which it is responsible. Article 330 Dialogue The Parties shall establish a regular dialogue to facilitate meeting the objectives of this Title. Article 331 Termination of this Title 1. This Title shall cease to apply on 30 June 2026. 2. Notwithstanding paragraph 1, between 1 July 2026 and 31 December 2026, the Partnership Council may decide that this Title will apply until 31 March 2027. Between 1 April 2027 and 31 December 2027, as well as at any point of time in any subsequent year, the Partnership Council may decide that this Title will apply until 31 March of the following year. 3. This Article applies without prejudice to Articles 509, 521 and 779. TITLE IX TRANSPARENCY Article 332 Objective 1. Recognising the impact that their respective regulatory environments may have on trade and investment between them, the Parties aim to provide a predictable regulatory environment and efficient procedures for economic operators, especially for small and medium-sized enterprises. 2. The Parties affirm their commitments in relation to transparency under the WTO Agreement, and build on those commitments in the provisions laid down in this Title. Article 333 Definition For the purposes of this Title, \"administrative decision\" means a decision or action with legal effect that applies to a specific person, good or service in an individual case, and covers the failure to take a decision or take such action when that is so required by the law of a Party. Article 334 Scope This Title applies with respect to Titles I to VIII and Titles X to XII of this Heading and Heading Six. Article 335 Publication 1. Each Party shall ensure that its laws, regulations, procedures and administrative rulings of general application are promptly published via an officially designated medium, and, where feasible, by electronic means, or are otherwise made available in such a manner as to enable any person to become acquainted with them. 2. To the extent appropriate, each Party shall provide an explanation of the objective of and rationale for measures referred to in paragraph 1. 3. Each Party shall provide a reasonable period of time between publication and entry into force of its laws and regulations, except when this is not possible for reasons of urgency. Article 336 Enquiries 1. Each Party shall establish or maintain appropriate and proportionate mechanisms for responding to questions from any person regarding any laws or regulations. 2. Each Party shall promptly provide information and respond to questions by the other Party pertaining to any law or regulation whether in force or planned, unless a specific mechanism is established under another provision of this Agreement. Article 337 Administration of measures of general application 1. Each Party shall administer its laws, regulations, procedures and administrative rulings of general application in an objective, impartial, and reasonable manner. 2. When administrative proceedings relating to persons, goods or services of the other Party are initiated in respect of the application of laws or regulations, each Party shall: (a) endeavour to provide persons who are directly affected by the administrative proceedings with reasonable notice in accordance with its laws and regulations, including a description of the nature of the proceedings, a statement of the legal authority under which the proceedings are initiated and a general description of any issues in controversy; and (b) afford such persons a reasonable opportunity to present facts and arguments in support of their positions prior to any final administrative decision insofar as time, the nature of the proceedings and the public interest permit. Article 338 Review and appeal 1. Each Party shall establish or maintain judicial, arbitral or administrative tribunals and procedures for the purpose of the prompt review and, if warranted, correction of administrative decisions. Each Party shall ensure that its tribunals carry out procedures for appeal or review in a non-discriminatory and impartial manner. Those tribunals shall be impartial and independent of the authority entrusted with administrative enforcement. 2. Each Party shall ensure that the parties to the proceedings as referred to in paragraph 1 are provided with a reasonable opportunity to support or defend their respective positions. 3. In accordance with its law, each Party shall ensure that any decisions adopted in proceedings as referred to in paragraph 1 are based on the evidence and submissions of record or, where applicable, on the record compiled by the competent administrative authority. 4. Each Party shall ensure that decisions as referred to in paragraph 3 shall be implemented by the authority entrusted with administrative enforcement, subject to appeal or further review as provided for in its law. Article 339 Relation to other Titles The provisions set out in this Title supplement the specific transparency rules set out in those Titles of this Heading with respect to which this Title applies. TITLE X GOOD REGULATORY PRACTICES AND REGULATORY COOPERATION Article 340 General principles 1. Each Party shall be free to determine its approach to good regulatory practices under this Agreement in a manner consistent with its own legal framework, practice, procedures and fundamental principles (49) underlying its regulatory system. 2. Nothing in this Title shall be construed as requiring a Party to: (a) deviate from its domestic procedures for preparing and adopting regulatory measures; (b) take actions that would undermine or impede the timely adoption of regulatory measures to achieve its public policy objectives; or (c) achieve any particular regulatory outcome. 3. Nothing in this Title shall affect the right of a Party to define or regulate its own levels of protection in pursuit or furtherance of its public policy objectives in areas such as: (a) public health; (b) human, animal or plant life and health, and animal welfare; (c) occupational health and safety; (d) labour conditions; (e) environment including climate change; (f) consumer protection; (g) social protection and social security; (h) data protection and cybersecurity; (i) cultural diversity; (j) integrity and stability of the financial system, and protection of investors; (k) energy security; and (l) anti-money laundering. For greater certainty, for the purposes of in particular point (c) and (d) of the first subparagraph, the different models of industrial relations, including the role and autonomy of social partners, as provided for in the law or national practices of a Party, shall continue to apply, including laws and practices concerning collective bargaining and the enforcement of collective agreements. 4. Regulatory measures shall not constitute a disguised barrier to trade. Article 341 Definitions For the purposes of this Title, the following definitions apply: (a) \"regulatory authority\" means: (i) for the Union, the European Commission; and (ii) for the United Kingdom, Her Majesty's Government of the United Kingdom of Great Britain and Northern Ireland, and the devolved administrations of the United Kingdom. (b) \"regulatory measures\" means: (i) for the Union: (A) regulations and directives, as provided for in Article 288 TFEU; and (B) implementing and delegated acts, as provided for in Articles 290 and 291 TFEU, respectively; and (ii) for the United Kingdom: (A) primary legislation; and (B) secondary legislation. Article 342 Scope 1. This Title applies to regulatory measures proposed or issued, as relevant, by the regulatory authority of each Party in respect of any matter covered by Titles I to IX, Title XI and Title XII of this Heading and Heading Six. 2. Articles 351 and 352 also apply to other measures of general application issued or proposed by the regulatory authority of a Party in respect of any matter covered by the Titles referred to in paragraph 1 of this Article which are relevant to regulatory cooperation activities, such as guidelines, policy documents or recommendations. 3. This Title does not apply to regulatory authorities and regulatory measures, regulatory practices or approaches of the Member States. 4. Any specific provisions in the Titles referred to in paragraph 1 of this Article shall prevail over the provisions of this Title to the extent necessary for the application of the specific provisions. Article 343 Internal coordination Each Party shall have in place internal coordination or review processes or mechanisms with respect to regulatory measures that its regulatory authority is preparing. Such processes or mechanisms should seek, inter alia, to: (a) foster good regulatory practices, including those set forth in this Title; (b) identify and avoid unnecessary duplication and inconsistent requirements between the Party's own regulatory measures; (c) ensure compliance with the Party's international trade and investment obligations; and (d) promote the consideration of the impact of the regulatory measures under preparation, including the impact on small and medium-sized enterprises (50), in accordance with its respective rules and procedures. Article 344 Description of processes and mechanisms Each Party shall make publicly available descriptions of the processes or mechanisms used by its regulatory authority to prepare, evaluate or review regulatory measures. Those descriptions shall refer to relevant rules, guidelines or procedures, including those regarding opportunities for the public to provide comments. Article 345 Early information on planned regulatory measures 1. Each Party shall make publicly available, in accordance with its respective rules and procedures on at least an annual basis, a list of planned major (51) regulatory measures that its regulatory authority reasonably expects to propose or adopt within a year. The regulatory authority of each Party may determine what constitutes a major regulatory measure for the purposes of its obligations under this Title. 2. With respect to each major regulatory measure included in the list referred to in paragraph 1, each Party should also make publicly available, as early as possible: (a) a brief description of its scope and objectives; and (b) if available, the estimated time for its adoption, including any opportunities for public consultation. Article 346 Public consultation 1. When preparing a major regulatory measure, each Party, in accordance with its respective rules and procedures, shall ensure that its regulatory authority: (a) publishes either the draft regulatory measure or consultation documents providing sufficient details about the regulatory measure under preparation to allow any person to assess whether and how that person's interests might be significantly affected; (b) offers, on a non-discriminatory basis, reasonable opportunities for any person to provide comments; and (c) considers the comments received. 2. Each Party shall ensure that its regulatory authority makes use of electronic means of communication and shall seek to maintain online services that are available to the public free of charge for the purposes of publishing the relevant regulatory measures or documents of the kind referred to in point (a) of paragraph 1 and of receiving comments related to public consultations. 3. Each Party shall ensure that its regulatory authority makes publicly available, in accordance with its respective rules and procedures, a summary of the results of the public consultations referred to in this Article. Article 347 Impact assessment 1. Each Party affirms its intention to ensure that its regulatory authority carries out, in accordance with its respective rules and procedures, impact assessments for any major regulatory measures it prepares. Such rules and procedures may provide for exceptions. 2. When carrying out an impact assessment, each Party shall ensure that its regulatory authority has processes and mechanisms in place that promote the consideration of the following factors: (a) the need for the regulatory measure, including the nature and the significance of the problem that the regulatory measure intends to address; (b) any feasible and appropriate regulatory or non-regulatory options that would achieve the Party's public policy objectives, including the option of not regulating; (c) to the extent possible and relevant, the potential social, economic and environmental impact of those options, including the impact on international trade and investment and, in accordance with its respective rules and procedures, the impact on small and medium-sized enterprises; and (d) where appropriate, how the options under consideration relate to relevant international standards, including the reasons for any divergence. 3. With respect to an impact assessment that a regulatory authority has conducted for a regulatory measure, each Party shall ensure that its regulatory authority prepares a final report detailing the factors it considered in its assessment and its relevant findings. To the extent possible, each Party shall make such reports publicly available no later than when the proposal for a regulatory measure as referred to in point (b)(i)(A) or (b)(ii)(A) of Article 341 or a regulatory measure as referred to in point (b)(i)(B) or (b)(ii)(B) of that Article has been made publicly available. Article 348 Retrospective evaluation 1. Each Party shall ensure that its regulatory authority has in place processes or mechanisms for the purpose of carrying out periodic retrospective evaluations of regulatory measures in force, where appropriate. 2. When conducting a periodic retrospective evaluation, each Party shall endeavour to consider whether there are opportunities to more effectively achieve its public policy objectives and to reduce unnecessary regulatory burdens, including on small and medium-sized enterprises. 3. Each Party shall ensure that its regulatory authority makes publicly available any existing plans for and the results of such retrospective evaluations. Article 349 Regulatory register Each Party shall ensure that regulatory measures that are in effect are published in a designated register that identifies regulatory measures and that is publicly available online free of charge. The register should allow searches for regulatory measures by citations or by word. Each Party shall periodically update its register. Article 350 Exchange of information on good regulatory practices The Parties shall endeavour to exchange information on their good regulatory practices as set out in this Title, including in the Trade Specialised Committee on Regulatory Cooperation. Article 351 Regulatory cooperation activities 1. The Parties may engage in regulatory cooperation activities on a voluntary basis, without prejudice to the autonomy of their own decision-making and their respective legal orders. A Party may refuse to engage in or it may withdraw from regulatory cooperation activities. A Party that refuses to engage in or that withdraws from regulatory cooperation activities should explain the reasons for its decision to the other Party. 2. Each Party may propose a regulatory cooperation activity to the other Party. It shall present its proposal via the contact point designated in accordance with Article 353. The other Party shall review that proposal within a reasonable period and shall inform the proposing Party whether it considers the proposed activity to be suitable for regulatory cooperation. 3. In order to identify activities that are suitable for regulatory cooperation, each Party shall consider: (a) the list referred to in Article 345(1); and (b) proposals for regulatory cooperation activities submitted by persons of a Party that are substantiated and accompanied by relevant information. 4. If the Parties decide to engage in a regulatory cooperation activity, the regulatory authority of each Party shall endeavour, where appropriate: (a) to inform the regulatory authority of the other Party about the preparation of new or the revision of existing regulatory measures and other measures of general application referred to in Article 342(2) that are relevant to the regulatory cooperation activity; (b) on request, to provide information and discuss regulatory measures and other measures of general application referred to in Article 342(2) that are relevant to the regulatory cooperation activity; and (c) when preparing new or revising existing regulatory measures or other measures of general application referred to in Article 342(2), consider, to the extent feasible, any regulatory approach by the other Party on the same or a related matter. Article 352 Trade Specialised Committee on Regulatory Cooperation 1. The Trade Specialised Committee on Regulatory Cooperation shall have the following functions: (a) enhancing and promoting good regulatory practices and regulatory cooperation between the Parties; (b) exchanging views with respect to the cooperation activities proposed or carried out under Article 351; (c) encouraging regulatory cooperation and coordination in international fora, including, when appropriate, periodic bilateral exchanges of information on relevant ongoing or planned activities. 2. The Trade Specialised Committee on Regulatory Cooperation may invite interested persons to participate in its meetings. Article 353 Contact points Within a month after the entry into force of this Agreement, each Party shall designate a contact point to facilitate the exchange of information between the Parties. Article 354 Non-application of dispute settlement Title I of Part Six does not apply in respect of disputes regarding the interpretation and application of this Title. TITLE XI LEVEL PLAYING FIELD FOR OPEN AND FAIR COMPETITION AND SUSTAINABLE DEVELOPMENT CHAPTER 1 GENERAL PROVISIONS Article 355 Principles and objectives 1. The Parties recognise that trade and investment between the Union and the United Kingdom under the terms set out in this Agreement, require conditions that ensure a level playing field for open and fair competition between the Parties and that ensure that trade and investment take place in a manner conducive to sustainable development. 2. The Parties recognise that sustainable development encompasses economic development, social development and environmental protection, all three being interdependent and mutually reinforcing, and affirm their commitment to promoting the development of international trade and investment in a way that contributes to the objective of sustainable development. 3. Each Party reaffirms its ambition of achieving economy-wide climate neutrality by 2050. 4. The Parties affirm their common understanding that their economic relationship can only deliver benefits in a mutually satisfactory way if the commitments relating to a level playing field for open and fair competition stand the test of time, by preventing distortions of trade or investment, and by contributing to sustainable development. However the Parties recognise that the purpose of this Title is not to harmonise the standards of the Parties. The Parties are determined to maintain and improve their respective high standards in the areas covered by this Title. Article 356 Right to regulate, precautionary approach (52) and scientific and technical information 1. The Parties affirm the right of each Party to set its policies and priorities in the areas covered by this Title, to determine the levels of protection it deems appropriate and to adopt or modify its law and policies in a manner consistent with each Party's international commitments, including its commitments under this Title. 2. The Parties acknowledge that, in accordance with the precautionary approach, where there are reasonable grounds for concern that there are potential threats of serious or irreversible damage to the environment or human health, the lack of full scientific certainty shall not be used as a reason for preventing a Party from adopting appropriate measures to prevent such damage. 3. When preparing or implementing measures aimed at protecting the environment or labour conditions that may affect trade or investment, each Party shall take into account relevant and available scientific and technical information, international standards, guidelines and recommendations. Article 357 Dispute settlement Title I of Part Six does not apply to this Chapter, except for Article 356(2). Articles 408 and 409 apply to Article 355(3). CHAPTER 2 COMPETITION POLICY Article 358 Principles and definitions 1. The Parties recognise the importance of free and undistorted competition in their trade and investment relations. The Parties acknowledge that anticompetitive business practices may distort the proper functioning of markets and undermine the benefits of trade liberalisation. 2. For the purposes of this Chapter, an \"economic actor\" means an entity or a group of entities constituting a single economic entity, regardless of its legal status, that is engaged in an economic activity by offering goods or services on a market. Article 359 Competition law 1. In recognition of the principles set out in Article 358, each Party shall maintain a competition law which effectively addresses the following anticompetitive business practices: (a) agreements between economic actors, decisions by associations of economic actors and concerted practices which have as their object or effect the prevention, restriction or distortion of competition; (b) abuse by one or more economic actors of a dominant position; and (c) for the United Kingdom, mergers or acquisitions and, for the Union, concentrations, between economic actors which may have significant anticompetitive effects. 2. The competition law referred to in paragraph 1 shall apply to all economic actors irrespective of their nationality or ownership status. 3. Each Party may provide for exemptions from its competition law in pursuit of legitimate public policy objectives, provided that those exemptions are transparent and are proportionate to those objectives. Article 360 Enforcement 1. Each Party shall take appropriate measures to enforce its competition law in its territory. 2. Each Party shall maintain an operationally independent authority or authorities competent for the effective enforcement of its competition law. 3. Each Party shall apply its competition law in a transparent and non-discriminatory manner, respecting the principles of procedural fairness, including the rights of defence of the economic actors concerned, irrespective of their nationality or ownership status. Article 361 Cooperation 1. To achieve the objectives of this Chapter and to enhance the effective enforcement of their respective competition law, the Parties recognise the importance of cooperation between their respective competition authorities with regard to developments in competition policy and enforcement activities. 2. For the purposes of paragraph 1, the European Commission or the competition authorities of the Member States, on the one side, and the United Kingdom's competition authority or authorities, on the other side, shall endeavour to cooperate and coordinate, with respect to their enforcement activities concerning the same or related conduct or transactions, where doing so is possible and appropriate. 3. To facilitate the cooperation and coordination referred to in paragraphs 1 and 2, the European Commission and the competition authorities of the Member States, on the one side, and the United Kingdom's competition authority or authorities, on the other side, may exchange information to the extent permitted by each Party's law. 4. To implement the objectives of this Article, the Parties may enter into a separate agreement on cooperation and coordination between the European Commission, the competition authorities of the Member States and the United Kingdom's competition authority or authorities, which may include conditions for the exchange and use of confidential information. Article 362 Dispute settlement This Chapter shall not be subject to dispute settlement under Title I of Part Six. CHAPTER 3 SUBSIDY CONTROL Article 363 Definitions 1. For the purposes of this Chapter, the following definitions apply: (a) \"economic actor\" means an entity or a group of entities constituting a single economic entity, regardless of its legal status, that is engaged in an economic activity by offering goods or services on a market; (b) \"subsidy\" means financial assistance which: (i) arises from the resources of the Parties, including: (A) a direct or contingent transfer of funds such as direct grants, loans or loan guarantees; (B) the forgoing of revenue that is otherwise due; or (C) the provision of goods or services, or the purchase of goods or services; (ii) confers an economic advantage on one or more economic actors; (iii) is specific insofar as it benefits, as a matter of law or fact, certain economic actors over others in relation to the production of certain goods or services; and (iv) has, or could have, an effect on trade or investment between the Parties. 2. For the purposes of point (b)(iii) of paragraph 1: (a) a tax measure shall not be considered as specific unless: (i) certain economic actors obtain a reduction in the tax liability that they otherwise would have borne under the normal taxation regime; and (ii) those economic actors are treated more advantageously than others in a comparable position within the normal taxation regime; for the purposes of this point, a normal taxation regime is defined by its internal objective, by its features (such as the tax base, the taxable person, the taxable event or the tax rate) and by an authority which is autonomous institutionally, procedurally, economically and financially and has the competence to design the features of the taxation regime; (b) notwithstanding point (a), a subsidy shall not be regarded as specific if it is justified by principles inherent to the design of the general system; in the case of tax measures, examples of such inherent principles are the need to fight fraud or tax evasion, administrative manageability, the avoidance of double taxation, the principle of tax neutrality, the progressive nature of income tax and its redistributive purpose, or the need to respect taxpayers' ability to pay; (c) notwithstanding point (a), special purpose levies shall not be regarded as specific if their design is required by non-economic public policy objectives, such as the need to limit the negative impacts of certain activities or products on the environment or human health, insofar as the public policy objectives are not discriminatory (53). Article 364 Scope and exceptions 1. Articles 366, 367 and 374 do not apply to subsidies granted to compensate the damage caused by natural disasters or other exceptional non-economic occurrences. 2. Nothing in this Chapter prevents the Parties from granting subsidies of a social character that are targeted at final consumers. 3. Subsidies that are granted on a temporary basis to respond to a national or global economic emergency shall be targeted, proportionate and effective in order to remedy that emergency. Articles 367 and 374 do not apply to such subsidies. 4. This Chapter does not apply to subsidies where the total amount granted to a single economic actor is below 325 000 Special Drawing Rights over any period of three fiscal years. The Partnership Council may amend this threshold. 5. This Chapter does not apply to subsidies that are subject to the provisions of Part IV or Annex 2 of the Agreement on Agriculture and subsidies related to trade in fish and fish products. 6. This Chapter does not apply to subsidies related to the audio-visual sector. 7. Article 371 does not apply to subsidies financed by resources of a Party at supranational level. 8. For the purposes of subsidies to air carriers, any reference to \"effect on trade or investment between the Parties\" in this Chapter shall be read as \"effect on competition between air carriers of the Parties in the provision of air transport services\", including those air transport services not covered under Title I of Heading Two. Article 365 Services of public economic interest 1. Subsidies granted to economic actors assigned with particular tasks in the public interest, including public service obligations, are subject to Article 366 insofar as the application of the principles set out in that Article does not obstruct the performance in law or fact of the particular task assigned to the economic actor concerned. The task shall be assigned in advance in a transparent manner. 2. The Parties shall ensure that the amount of compensation granted to an economic actor that is assigned with a task in the public interest is limited to what is necessary to cover all or part of the costs incurred in the discharge of that task, taking into account the relevant receipts and a reasonable profit for discharging that task. The Parties shall ensure that the compensation granted is not used to cross-subsidise activities falling outside the scope of the assigned task. Compensation below 15 million Special Drawing Rights per task shall not be subject to the obligations under Article 369. The Partnership Council may amend this threshold. 3. This Chapter does not apply where the total compensation to an economic actor providing tasks in the public interest is below 750 000 Special Drawing Rights over any period of three fiscal years. The Partnership Council may amend this threshold. Article 366 Principles 1. With a view to ensuring that subsidies are not granted where they have or could have a material effect on trade or investment between the Parties, each Party shall have in place and maintain an effective system of subsidy control that ensures that the granting of a subsidy respects the following principles: (a) subsidies pursue a specific public policy objective to remedy an identified market failure or to address an equity rationale such as social difficulties or distributional concerns (\"the objective\"); (b) subsidies are proportionate and limited to what is necessary to achieve the objective; (c) subsidies are designed to bring about a change of economic behaviour of the beneficiary that is conducive to achieving the objective and that would not be achieved in the absence of subsidies being provided; (d) subsidies should not normally compensate for the costs the beneficiary would have funded in the absence of any subsidy; (e) subsidies are an appropriate policy instrument to achieve a public policy objective and that objective cannot be achieved through other less distortive means; (f) subsidies' positive contributions to achieving the objective outweigh any negative effects, in particular the negative effects on trade or investment between the Parties. 2. Without prejudice to paragraph 1 of this Article, each Party shall apply the conditions set out in Article 367, where relevant, if the subsidies concerned have or could have a material effect on trade or investment between the Parties. 3. It is for each Party to determine how its obligations under paragraphs 1 and 2 are implemented in the design of its subsidy control system in its own domestic law, provided that each Party shall ensure that the obligations under paragraphs 1 and 2 are implemented in its law in such a manner that the legality of an individual subsidy will be determined by the principles. Article 367 Prohibited subsidies and subsidies subject to conditions 1. The categories of the subsidies referred to in Article 366(2) and the conditions to be applied to them are as follows. The Partnership Council may update these provisions as necessary to ensure the operation of this Article over time. Subsidies in the form of unlimited guarantees 2. Subsidies in the form of a guarantee of debts or liabilities of an economic actor without any limitation as to the amount of those debts and liabilities or the duration of that guarantee shall be prohibited. Rescue and restructuring 3. Subsidies for restructuring an ailing or insolvent economic actor without the economic actor having prepared a credible restructuring plan shall be prohibited. The restructuring plan shall be based on realistic assumptions with a view to ensuring the return to long-term viability of the ailing or insolvent economic actor within a reasonable time period. During the preparation of the restructuring plan, the economic actor may receive temporary liquidity support in the form of loans or loan guarantees. Except for small and medium-sized enterprises, an economic actor or its owners, creditors or new investors shall contribute significant funds or assets to the cost of restructuring. For the purposes of this paragraph, an ailing or insolvent economic actor is one that would almost certainly go out of business in the short to medium term without the subsidy. 4. Other than in exceptional circumstances, subsidies for the rescue and restructuring of insolvent or ailing economic actors should only be allowed if they contribute to an objective of public interest by avoiding social hardship or preventing a severe market failure, in particular with regard to job losses or disruption of an important service that is difficult to replicate. Except in the case of unforeseeable circumstances not caused by the beneficiary, they should not be granted more than once in any five year period. 5. Paragraphs 3 and 4 do not apply to subsidies to ailing or insolvent banks, credit institutions and insurance companies. Banks, credit institutions and insurance companies 6. Without prejudice to Article 184, subsidies to restructure banks, credit institutions and insurance companies may only be granted on the basis of a credible restructuring plan that restores long-term viability. If a return to long-term viability cannot be credibly demonstrated, any subsidy to banks, credit institutions and insurance companies shall be limited to what is needed to ensure their orderly liquidation and exit from the market while minimising the amount of the subsidy and its negative effect on trade or investment between the Parties. 7. It shall be ensured that the granting authority is properly remunerated for the restructuring subsidy and that the beneficiary, its shareholders, its creditors or the business group to which the beneficiary belongs, contribute significantly to the restructuring or liquidation costs from their own resources. Subsidies to support liquidity provisions shall be temporary, shall not be used to absorb losses and shall not become capital support. Proper remuneration shall be paid to the granting authority for the subsidies granted to support liquidity provisions. Export subsidies 8. Subsidies that are contingent in law or in fact (54), whether solely or as one of several other conditions, upon export performance relating to goods or services, shall be prohibited, except in relation to: (a) short-term credit insurance for non-marketable risks; or (b) export credits and export credit guarantee or insurance programmes that are permissible in accordance with the SCM Agreement, read with any adjustments necessary for context. 9. For the purposes of point (a) of paragraph 8, \"marketable risk\" means commercial and political risks with a maximum risk period of less than two years on public and non-public buyers in marketable risk countries (55). A country may be understood to be temporarily removed from the group of marketable risk countries if there is a lack of sufficient private market capacity because of: (a) a significant contraction of private credit insurance capacity; (b) a significant deterioration of sovereign sector rating; or (c) a significant deterioration of corporate sector performance. 10. Such temporary removal of a marketable risk country shall take effect, as far as a Party is concerned, in accordance with a decision of that Party on the basis of the criteria in paragraph 9, and only if that Party adopts such a decision. The publication of that decision shall be deemed to constitute notice to the other Party of such temporary removal as far as the former Party is concerned. 11. If a subsidised insurer provides export credit insurance, any insurance for marketable risks shall be provided on a commercial basis. In such a case, the insurer shall not directly or indirectly benefit from subsidies for the provision of insurance for marketable risks. Subsidies contingent upon the use of domestic content 12. Without prejudice to Articles 132 and 133, subsidies contingent, whether solely or as one of several other conditions, upon the use of domestic over imported goods or services shall be prohibited. Large cross-border or international cooperation projects 13. Subsidies may be granted in the context of large cross-border or international cooperation projects, such as those for transport, energy, the environment, research and development, and first deployment projects to incentivise the emergence and deployment of new technologies (excluding manufacturing). The benefits of such cross-border or international cooperation projects must not be limited to the economic actors or to the sector or the States participating, but must have wider benefit and relevance through spillover effects that do not exclusively accrue to the State that grants the subsidy, the relevant sector and beneficiary. Energy and environment 14. The Parties recognise the importance of a secure, affordable and sustainable energy system and environmental sustainability, notably in relation to the fight against climate change which represents an existential threat to humanity. Therefore, without prejudice to Article 366, subsidies in relation to energy and environment shall be aimed at, and incentivise the beneficiary in, delivering a secure, affordable and sustainable energy system and a well-functioning and competitive energy market or increasing the level of environmental protection compared to the level that would be achieved in absence of the subsidy. Such subsidies shall not relieve the beneficiary from liabilities arising from its responsibilities as a polluter under the law of the relevant Party. Subsidies to air carriers for the operation of routes 15. Subsidies shall not be granted to an air carrier (56) for the operation of routes except: (a) where there is a public service obligation, in accordance with Article 365; (b) in special cases where this funding provides benefits for society at large; or (c) as start-up subsidies for opening new routes to regional airports provided that such subsidies increase the mobility of citizens and stimulate regional development. Article 368 Use of subsidies Each Party shall ensure that economic actors use subsidies only for the specific purpose for which they are granted. Article 369 Transparency 1. With respect to any subsidy granted or maintained within its territory, each Party shall within six months from the granting of the subsidy make publicly available, on an official website or a public database, the following information: (a) the legal basis and policy objective or purpose of the subsidy; (b) the name of the recipient of the subsidy when available; (c) the date of the grant of the subsidy, the duration of the subsidy and any other time limits attached to the subsidy; and (d) the amount of the subsidy or the amount budgeted for the subsidy. 2. For subsidies in the form of tax measures, information shall be made public within one year from the date the tax declaration is due. The transparency obligations for subsidies in the form of tax measures concern the same information as listed in paragraph 1, except for the information required under point (d) of that paragraph, which may be provided as a range. 3. In addition to the obligation set out in paragraph 1, the Parties shall make subsidy information available in accordance with paragraph 4 or 5. 4. For the Union, compliance with paragraph 3 of this Article means that with respect to any subsidy granted or maintained within its territory, within six months from the grant of the subsidy, information is made publicly available, on an official website or a public database, that allows interested parties to assess compliance with the principles set out in Article 366. 5. For the United Kingdom, compliance with paragraph 3 means that the United Kingdom shall ensure that: (a) if an interested party communicates to the granting authority that it may apply for a review by a court or tribunal of: (i) the grant of a subsidy by a granting authority; or (ii) any relevant decision by the granting authority or the independent body or authority; (b) then, within 28 days of the request being made in writing, the granting authority, independent body or authority shall provide that interested party with the information that allows the interested party to assess the application of the principles set out in Article 366, subject to any proportionate restrictions which pursue a legitimate objective, such as commercial sensitivity, confidentiality or legal privilege. The information referred to in point (b) of the first subparagraph shall be provided to the interested party for the purposes of enabling it to make an informed decision as to whether to make a claim or to understand and properly identify the issues in dispute in the proposed claim. 6. For the purposes of this Article and Articles 372 and 373, \"interested party\" means any natural or legal person, economic actor or association of economic actors whose interest might be affected by the granting of a subsidy, in particular the beneficiary, economic actors competing with the beneficiary or relevant trade associations. 7. The obligations in this Article are without prejudice to the obligations of the Parties under their respective laws concerning the freedom of information or access to documents. Article 370 Consultations on subsidy control 1. If a Party considers that a subsidy has been granted by the other Party or that there is clear evidence that the other Party intends to grant a subsidy and that the granting of the subsidy has or could have a negative effect on trade or investment between the Parties, it may request to the other Party to provide an explanation of how the principles set out in Article 366 have been respected with regard to that subsidy. 2. A Party may also request the information listed in Article 369(1) to the extent that the information has not already been made publicly available on an official website or a public database as referred to in Article 369(1), or to the extent that the information has not been made available in an easily and readily accessible manner. 3. The other Party shall provide the requested information in writing no later than 60 days of the receipt of the request. If any requested information cannot be provided, that Party shall explain the absence of such information in its written response. 4. If after receiving the information requested, the requesting Party still considers that the subsidy granted or intended to be granted by the other Party has or could have a negative effect on trade or investment between the Parties, the requesting Party may request consultations within the Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development. The request shall be in writing and shall include an explanation of the requesting Party's reasons for requesting the consultation. 5. The Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development shall make every attempt to arrive at a mutually satisfactory resolution of the matter. It shall hold its first meeting within 30 days of the request for consultation. 6. The timeframes for the consultations referred to in paragraphs 3 and 5 may be extended by agreement between the Parties. Article 371 Independent authority or body and cooperation 1. Each Party shall establish or maintain an operationally independent authority or body with an appropriate role in its subsidy control regime. That independent authority or body shall have the necessary guarantees of independence in exercising its operational functions and shall act impartially. 2. The Parties shall encourage their respective independent authorities or bodies to cooperate with each other on issues of common interest within their respective functions, including the application of Articles 363 to 369 as applicable, within the limits established by their respective legal frameworks. The Parties, or their respective independent authorities or bodies, may agree upon a separate framework regarding cooperation between those independent authorities. Article 372 Courts and tribunals 1. Each Party shall ensure, in accordance with its general and constitutional laws and procedures, that its courts or tribunals are competent to: (a) review subsidy decisions taken by a granting authority or, where relevant, the independent authority or body for compliance with that Party's law implementing Article 366; (b) review any other relevant decisions of the independent authority or body and any relevant failure to act; (c) impose remedies that are effective in relation to point (a) or (b), including the suspension, prohibition or requirement of action by the granting authority, the award of damages, and the recovery of a subsidy from its beneficiary, if and to the extent that those remedies are available under the respective laws on the date of entry into force of this Agreement; (d) hear claims from interested parties in respect of subsidies that are subject to this Chapter where an interested party has standing to bring a claim in respect of a subsidy under that Party's law. 2. Each Party shall have the right to intervene with the permission, where required, of the court or tribunal concerned, in accordance with the general laws and procedures of the other Party in cases referred to in paragraph 1. 3. Without prejudice to the obligations to maintain or, where necessary, to create the competencies, remedies and rights of intervention referred to in paragraphs 1 and 2 of this Article, and Article 373, nothing in this Article requires either Party to create rights of action, remedies, procedures, or widen the scope or grounds of review of decisions of their respective public authorities, beyond those existing under its law on the date of entry into force of this Agreement. 4. Nothing in this Article requires either Party to widen the scope or grounds of review by its courts and tribunals of Acts of the United Kingdom Parliament, of acts of the European Parliament and the Council of the European Union, or of acts of the Council of the European Union beyond those existing under its law on the date of entry into force of this Agreement. (57) Article 373 Recovery 1. Each Party shall have in place an effective mechanism of recovery in respect of subsidies in accordance with the following provisions, without prejudice to other remedies that exist in that Party's law. (58) 2. Each Party shall ensure that, provided that the interested party as defined in Article 369 has challenged a decision to grant a subsidy before a court or a tribunal within the specified time period, as defined in paragraph 3 of this Article, recovery may be ordered if a court or tribunal of a Party makes a finding of a material error of law, in that: (a) a measure constituting a subsidy was not treated by the grantor as a subsidy; (b) the grantor of a subsidy has failed to apply the principles set out in Article 366, as implemented in that Party's law, or applied them in a manner which falls below the standard of review applicable in that Party's law; or (c) the grantor of a subsidy has, by deciding to grant that subsidy, acted outside the scope of its powers or misused those powers in relation to the principles set out in Article 366, as implemented in that Party's law. 3. For the purposes of this Article, the specified time period shall be determined as follows: (a) for the Union, it shall commence on the date on which information specified in Article 369(1), (2) and (4) was made available on the official website or public database and be no shorter than one month. (b) for the United Kingdom: (i) it shall commence on the date on which information specified in Article 369(1) and (2) was made available on the official website or public database; (ii) it shall terminate one month later, unless, prior to that date, the interested party has requested information under the process specified in Article 369(5); (iii) once the interested party has received the information identified in point (b) of Article 369(5) sufficient for the purposes identified in Article 369(5), there shall be a further one month period at the end of which the specified time period shall terminate; (iv) the date of receipt of the information in point (iii) will be the date on which the granting authority certifies that it has provided the information identified in point (b) of Article 369(5) sufficient for those purposes, irrespective of further or clarificatory correspondence after that date; (v) the time periods identified in points (i), (ii) and (iii) may be increased by legislation. 4. For the purposes of point (b) of paragraph 3 in relation to schemes, the specified time period commences when the information under point (b) of this paragraph is published, not when subsequent payments are made, where: (a) a subsidy is ostensibly granted in accordance with the terms of a scheme; (b) the maker of the scheme has made publicly available the information required to be published by Article 369(1) and (2) in respect of the scheme; and (c) the information provided about the scheme under point (b) of this paragraph contains information about the subsidy that would enable an interested party to determine whether it may be affected by the scheme, which at a minimum shall cover the purpose of the subsidy, the categories of beneficiary, the terms and conditions of eligibility for the subsidy and the basis for the calculation of the subsidy (including any relevant conditions relating to subsidy ratios or amounts). 5. For the purposes of this Article, recovery of a subsidy is not required where a subsidy is granted on the basis of an Act of the Parliament of the United Kingdom, of an act of the European Parliament and of the Council of the European Union or of an act of the Council of the European Union. 6. Nothing in this Article prevents a Party from choosing to provide additional situations where recovery is a remedy, beyond those specified in this Article, in accordance with its law. 7. The Parties recognise that recovery is an important remedial tool in any system of subsidy control. At the request of either Party, the Parties shall within the Partnership Council consider additional or alternative mechanisms for recovery, as well as corresponding amendments to this Article. Within the Partnership Council, either Party may propose amendments to allow for different arrangements for their respective mechanisms for recovery. A Party shall consider a proposal made by the other Party in good faith and agree to it, provided that that Party considers that it contains arrangements which represent at least as effective a means of securing recovery as the existing mechanisms of the other Party. The Partnership Council may then make corresponding amendments to this Article. (59) Article 374 Remedial measures 1. A Party may deliver to the other Party a written request for information and consultations regarding a subsidy that it considers causes, or there is a serious risk that it will cause, a significant negative effect on trade or investment between the Parties. The requesting Party should provide in that request all relevant information to enable the Parties to find a mutually acceptable solution, including a description of the subsidy and the concerns of the requesting Party regarding its effect on trade or investment. 2. No later than 30 days from the date of delivery of the request, the requested Party shall deliver a written response providing the requested information to the requesting Party, and the Parties shall enter into consultations, which shall be deemed concluded 60 days from the date of delivery of that request, unless the Parties agree otherwise. Such consultations, and in particular all information designated as confidential and positions taken by the Parties during consultations, shall be confidential and shall be without prejudice to the rights of either Party in any further proceedings. 3. No earlier than 60 days from the date of delivery of the request referred to in paragraph 1, the requesting Party may unilaterally take appropriate remedial measures if there is evidence that a subsidy of the requested Party causes, or there is a serious risk that it will cause, a significant negative effect on trade or investment between the Parties. 4. No earlier than 45 days from the date of delivery of the request referred to in paragraph 1, the requesting Party shall notify the requested Party of the remedial measures that it intends to take in accordance with paragraph 3. The requesting Party shall provide all relevant information in relation to the measures that it intends to take to enable the Parties to find a mutually acceptable solution. The requesting Party may not take those remedial measures earlier than 15 days from the date of delivery of the notification of those measures to the requested Party. 5. A Party's assessment of the existence of a serious risk of a significant negative effect shall be based on facts and not merely on allegation, conjecture or remote possibility. The change in circumstances that would create a situation in which the subsidy would cause such a significant negative effect must be clearly predictable. 6. A Party's assessment of the existence of a subsidy or of a significant negative effect on trade or investment between the Parties caused by the subsidy shall be based on reliable evidence and not merely on conjecture or remote possibility, and shall relate to identifiable goods, service suppliers or other economic actors, including, if relevant, in the case of subsidy schemes. 7. The Partnership Council may maintain an illustrative list of what would amount to a significant negative effect on trade or investment between the Parties within the meaning of this Article. This shall be without prejudice to the right of the Parties to take remedial measures. 8. The remedial measures taken pursuant to paragraph 3 shall be restricted to what is strictly necessary and proportionate in order to remedy the significant negative effect caused or to address the serious risk of such an effect. Priority shall be given to measures that will least disturb the functioning of this Agreement. 9. Within five days from the date on which the remedial measures referred to in paragraph 3 enter into effect and without having prior recourse to consultations in accordance with Article 738, the notified Party may request, in accordance with Article 739(2), the establishment of an arbitration tribunal by means of a written request delivered to the requesting Party in order for the arbitration tribunal to decide whether: (a) a remedial measure taken by the requesting Party is inconsistent with paragraph 3 or 8; (b) the requesting Party did not participate in the consultations after the requested Party delivered the requested information and agreed to the holding of such consultations; or (c) there was a failure to take or notify a remedial measure in accordance with the time periods referred to in paragraph 3 or 4 respectively. That request shall not have a suspensive effect on the remedial measures. Furthermore, the arbitration tribunal shall not assess the application by the Parties of Articles 366 and 367. 10. The arbitration tribunal established following the request referred to in paragraph 9 of this Article shall conduct its proceedings in accordance with Article 760 and deliver its final ruling within 30 days from its establishment. 11. In the case of a finding against the respondent Party, the respondent Party shall, at the latest 30 days from the date of delivery of the ruling of the arbitration tribunal, deliver a notification to the complaining Party of any measure that it has taken to comply with that ruling. 12. Following a finding against the respondent Party in the procedure referred to paragraph 10 of this Article, the complaining Party may request the arbitration tribunal, within 30 days from its ruling, to determine a level of suspension of obligations under this Agreement or a supplementing agreement not exceeding the level equivalent to the nullification or impairment caused by the application of the remedial measures, if it finds that the inconsistency of the remedial measures with paragraph 3 or 8 of this Article is significant. The request shall propose a level of suspension of obligations in accordance with the principles set out in Article 761. The complaining Party may suspend obligations under this Agreement or a supplementing agreement in accordance with the level of suspension of obligations determined by the arbitration tribunal. Such suspension shall not be applied sooner than 15 days following such ruling. 13. A Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from taking measures pursuant to this Article, including where those measures consist in the suspension of obligations under this Agreement or under a supplementing agreement. 14. For the purposes of assessing whether imposing or maintaining remedial measures on imports of the same product is restricted to what is strictly necessary or proportionate for the purposes of this Article, a Party: (a) shall take into account countervailing measures applied or maintained pursuant to Article 32(3); and (b) may take into account anti-dumping measures applied or maintained pursuant to Article 32(3). 15. A Party shall not apply simultaneously a remedial measure under this Article and a rebalancing measure under Article 411 to remedy the impact on trade or investment caused directly by the same subsidy. 16. If the Party against which remedial measures were taken does not submit a request pursuant to paragraph 9 of this Article within the time period laid down in that paragraph, that Party may initiate the arbitration procedure referred to in Article 739 to challenge a remedial measure on the grounds set out in paragraph 9 of this Article without having prior recourse to consultations in accordance with Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. 17. For the purposes of the proceedings under paragraphs 9 and 16, in assessing whether a remedial measure is strictly necessary or proportionate, the arbitration tribunal shall pay due regard to the principles set out in paragraphs 5 and 6, as well as to paragraphs 13, 14 and 15. Article 375 Dispute settlement 1. Subject to paragraphs 2 and 3 of this Article, Title I of Part Six applies to disputes between the Parties concerning the interpretation and application of this Chapter, except for Articles 371 and 372. 2. An arbitration tribunal shall have no jurisdiction regarding: (a) an individual subsidy, including whether such a subsidy has respected the principles set out in Article 366(1), other than with regard to the conditions set out in Article 367(2), Article 367(3), (4) and (5), Article 367(8) to (11) and Article 367(12); and (b) whether the recovery remedy within the meaning of Article 373 has been correctly applied in any individual case. 3. Title I of Part Six shall apply to Article 374 in accordance with that Article and Article 760. CHAPTER 4 STATE-OWNED ENTERPRISES, ENTERPRISES GRANTED SPECIAL RIGHTS OR PRIVILEGES AND DESIGNATED MONOPOLIES Article 376 Definitions 1. For the purposes of this Chapter, the following definitions apply: (a) \"Arrangement\" means the Arrangement on Officially Supported Export Credits, developed within the framework of the OECD or a successor undertaking, whether developed within or outside of the OECD framework, that has been adopted by at least 12 original WTO Members that were Participants to the Arrangement as of 1 January 1979; (b) \"commercial activities\" means activities, the end result of which is the production of a good or the supply of a service to be sold in the relevant market in quantities and at prices determined by an enterprise on the basis of the conditions of supply and demand, and which are undertaken with an orientation towards profit-making; activities undertaken by an enterprise which operates on a non-profit basis or a cost-recovery basis are not activities undertaken with an orientation towards profit-making; (c) \"commercial considerations\" means considerations of price, quality, availability, marketability, transportation and other terms and conditions of purchase or sale, or other factors that would normally be taken into account in the commercial decisions of a privately owned enterprise operating according to market economy principles in the relevant business or industry; (d) \"covered entity\" means: (i) a designated monopoly; (ii) an enterprise granted special rights or privileges; or (iii) a State-owned enterprise; (e) \"designated monopoly\" means an entity, including a consortium or a government agency, that, in a relevant market in the territory of a Party, is designated as the sole supplier or purchaser of a good or service, but does not include an entity that has been granted an exclusive intellectual property right solely by reason of such grant; in this context, designate means to establish or authorise a monopoly, or to expand the scope of a monopoly to cover an additional good or service; (f) \"enterprise\" means enterprise as defined in point (g) of Article 124; (g) \"enterprise granted special rights or privileges\" means any enterprise, public or private, to which a Party has granted special rights or privileges, in law or in fact; (h) \"service supplied in the exercise of governmental authority\" means a service supplied in the exercise of governmental authority as defined in GATS; (i) \"special rights or privileges\" means rights or privileges by which a Party designates or limits to two or more the number of enterprises authorised to supply a good or service, other than according to objective, proportional and non-discriminatory criteria, substantially affecting the ability of any other enterprise to supply the same good or service in the same geographical area or product market under substantially equivalent conditions; (j) \"State-owned enterprise\" means an enterprise in which a Party: (i) directly owns more than 50 % of the share capital; (ii) controls, directly or indirectly, the exercise of more than 50 % of the voting rights; (iii) holds the power to appoint a majority of the members of the board of directors or any other equivalent management body; or (iv) has the power to exercise control over the enterprise. For the establishment of control, all relevant legal and factual elements shall be taken into account on a case-by-case basis. Article 377 Scope 1. This Chapter applies to covered entities, at all levels of government, engaged in commercial activities. If a covered entity engages in both commercial and non-commercial activities, only the commercial activities are covered by this Chapter. 2. This Chapter does not apply to: (a) covered entities when acting as procuring entities, as defined in each Party's Annexes 1 to 3 to Appendix I to the GPA and paragraph 1 of each Party's respective subsections of Section B of Annex 25, conducting covered procurement as defined in Article 277(2); (b) any service supplied in the exercise of governmental authority. 3. This Chapter does not apply to a covered entity, if in any one of the three previous consecutive fiscal years the annual revenue derived from the commercial activities of the enterprise or monopoly concerned was less than 100 million Special Drawing Rights. 4. Article 380 does not apply to the supply of financial services by a covered entity pursuant to a government mandate, if that supply of financial services: (a) supports exports or imports, provided that those services are: (i) not intended to displace commercial financing; or (ii) offered on terms no more favourable than those that could be obtained for comparable financial services in the commercial market; or (b) supports private investment outside the territory of the Party, provided that those services are: (i) not intended to displace commercial financing; or (ii) offered on terms no more favourable than those that could be obtained for comparable financial services in the commercial market; or (c) is offered on terms consistent with the Arrangement, if the supply of those services falls within the scope of the Arrangement. 5. Without prejudice to paragraph 3 of this Article, Article 380 does not apply to the following sectors: audio-visual services; national maritime cabotage (60); and inland waterways transport, as set out in Article 123(5). 6. Article 380 does not apply to the extent that a covered entity of a Party makes purchases or sales of goods or services pursuant to: (a) any existing non-conforming measure that the Party maintains, continues, renews or amends in accordance with Article 133(1) or 139(1) as set out in its Schedules to Annexes 19 and 20, as applicable; or (b) any non-conforming measure that the Party adopts or maintains with respect to sectors, subsectors, or activities in accordance with Article 133(2) or 139(2) as set out in its Schedules to Annexes 19 and 20, as applicable. Article 378 Relationship with the WTO Agreement The Parties affirm their rights and obligations under paragraphs 1 to 3 of Article XVII of GATT 1994, the Understanding on the Interpretation of Article XVII of the GATT 1994, as well as under paragraphs 1, 2 and 5 of Article VIII of GATS. Article 379 General provisions 1. Without prejudice to the rights and obligations of each Party under this Chapter, nothing in this Chapter prevents a Party from establishing or maintaining a covered entity. 2. Neither Party shall require or encourage a covered entity to act in a manner inconsistent with this Chapter. Article 380 Non-discriminatory treatment and commercial considerations 1. Each Party shall ensure that each of its covered entities, when engaging in commercial activities: (a) acts in accordance with commercial considerations in its purchase or sale of a good or service, except to fulfil any terms of its public service mandate that are not inconsistent with point (b) or (c); (b) in its purchase of a good or service: (i) accords to a good or service supplied by an enterprise of the other Party treatment no less favourable than it accords to a like good or a like service supplied by enterprises of the Party; and (ii) accords to a good or service supplied by a covered entity in the Party's territory treatment no less favourable than it accords to a like good or a like service supplied by enterprises of the Party in the relevant market in the Party's territory; and (c) in its sale of a good or service: (i) accords to an enterprise of the other Party treatment no less favourable than it accords to enterprises of the Party; and (ii) accords to a covered entity in the Party's territory, treatment no less favourable than it accords to enterprises of the Party in the relevant market in the Party's territory. (61) 2. Points (b) and (c) of paragraph 1 do not preclude a covered entity from: (a) purchasing or supplying goods or services on different terms or conditions, including terms or conditions relating to price, provided that those different terms or conditions are in accordance with commercial considerations; or (b) refusing to purchase or supply goods or services, provided that such refusal is made in accordance with commercial considerations. Article 381 Regulatory framework 1. Each Party shall respect and make best use of relevant international standards including the OECD Guidelines on Corporate Governance of State-Owned Enterprises. 2. Each Party shall ensure that any regulatory body, and any other body exercising a regulatory function, that that Party establishes or maintains: (a) is independent from, and not accountable to, any of the enterprises regulated by that body; and (b) in like circumstances, acts impartially with respect to all enterprises regulated by that body, including covered entities; the impartiality with which the body exercises its regulatory functions is to be assessed by reference to a general pattern or practice of that body. For those sectors in which the Parties have agreed to specific obligations relating to such a body in this Agreement, the relevant provisions of this Agreement shall prevail. 3. Each Party shall apply its laws and regulations to covered entities in a consistent and non-discriminatory manner. Article 382 Information exchange 1. A Party which has reason to believe that its interests under this Chapter are being adversely affected by the commercial activities of an entity of the other Party may request the other Party in writing to provide information on the commercial activities of that entity related to the carrying out of the provisions of this Chapter in accordance with paragraph 2. 2. Provided that the request referred to in paragraph 1 includes an explanation of how the activities of the entity may be affecting the interests of the requesting Party under this Chapter and indicates which of the following categories of information is or are to be provided, the requested Party shall provide the information so requested: (a) the ownership and the voting structure of the entity, indicating the cumulative percentage of shares and the percentage of voting rights that the requested Party and its covered entities cumulatively have in the entity; (b) a description of any special shares or special voting or other rights that the requested Party or its covered entities hold, to the extent that such rights are different from those attached to the general common shares of the entity; (c) a description of the organisational structure of the entity and the composition of its board of directors or of any equivalent body; (d) a description of the government departments or public bodies which regulate or monitor the entity, a description of the reporting requirements imposed on it by those departments or public bodies, and the rights and practices of those departments or public bodies with respect to the appointment, dismissal or remuneration of senior executives and members of its board of directors or any equivalent body; (e) the annual revenue and total assets of the entity over the most recent three-year period for which information is available; (f) any exemptions, immunities and related measures from which the entity benefits under the laws and regulations of the requested Party; (g) any additional information regarding the entity that is publicly available, including annual financial reports and third-party audits. 3. Paragraphs 1 and 2 do not require a Party to disclose confidential information the disclosure of which would be inconsistent with its laws and regulations, would impede law enforcement, or otherwise would be contrary to the public interest or would prejudice the legitimate commercial interests of particular enterprises. 4. If the requested information is not available, the requested Party shall provide to the requesting Party, in writing, the reasons why that information is not available. CHAPTER 5 TAXATION Article 383 Good governance The Parties recognise and commit to implementing the principles of good governance in the area of taxation, in particular the global standards on tax transparency and exchange of information and fair tax competition. The Parties reiterate their support for the OECD Base Erosion and Profit Shifting (BEPS) Action Plan and affirm their commitment to implementing the OECD minimum standards against BEPS. The Parties will promote good governance in tax matters, improve international cooperation in the area of taxation and facilitate the collection of tax revenues. Article 384 Taxation standards 1. A Party shall not weaken or reduce the level of protection provided for in its legislation at the end of the transition period below the level provided for by the standards and rules which have been agreed in the OECD at the end of the transition period, in relation to: (a) the exchange of information, whether upon request, spontaneously or automatically, concerning financial accounts, cross-border tax rulings, country-by-country reports between tax administrations, and potential cross-border tax planning arrangements; (b) rules on interest limitation, controlled foreign companies and hybrid mismatches. 2. A Party shall not weaken or reduce the level of protection provided for in its legislation at the end of the transition period in respect of public country-by-country reporting by credit institutions and investment firms, other than small and non-interconnected investment firms. Article 385 Dispute settlement This Chapter shall not be subject to dispute settlement under Title I of Part Six. CHAPTER 6 LABOUR AND SOCIAL STANDARDS Article 386 Definition 1. For the purposes of this Chapter, \"labour and social levels of protection\" means the levels of protection provided overall in a Party's law and standards (62), in each of the following areas: (a) fundamental rights at work; (b) occupational health and safety standards; (c) fair working conditions and employment standards; (d) information and consultation rights at company level; or (e) restructuring of undertakings. 2. For the Union, \"labour and social levels of protection\" means labour and social levels of protection that are applicable to and in, and are common to, all Member States. Article 387 Non-regression from levels of protection 1. The Parties affirm the right of each Party to set its policies and priorities in the areas covered by this Chapter, to determine the labour and social levels of protection it deems appropriate and to adopt or modify its law and policies in a manner consistent with each Party's international commitments, including those under this Chapter. 2. A Party shall not weaken or reduce, in a manner affecting trade or investment between the Parties, its labour and social levels of protection below the levels in place at the end of the transition period, including by failing to effectively enforce its law and standards. 3. The Parties recognise that each Party retains the right to exercise reasonable discretion and to make bona fide decisions regarding the allocation of labour enforcement resources with respect to other labour law determined to have higher priority, provided that the exercise of that discretion, and those decisions, are not inconsistent with its obligations under this Chapter. 4. The Parties shall continue to strive to increase their respective labour and social levels of protection referred to in this Chapter. Article 388 Enforcement For the purposes of enforcement as referred to in Article 387 each Party shall have in place and maintain a system for effective domestic enforcement and, in particular, an effective system of labour inspections in accordance with its international commitments relating to working conditions and the protection of workers; ensure that administrative and judicial proceedings are available that allow public authorities and individuals with standing to bring timely actions against violations of the labour law and social standards; and provide for appropriate and effective remedies, including interim relief, as well as proportionate and dissuasive sanctions. In the domestic implementation and enforcement of Article 387, each Party shall respect the role and autonomy of the social partners at a national level, where relevant, in line with applicable law and practice. Article 389 Dispute settlement 1. The Parties shall make all efforts through dialogue, consultation, exchange of information and cooperation to address any disagreement on the application of this Chapter. 2. By way of derogation from Title I of Part Six, in the event of a dispute between the Parties regarding the application of this Chapter, the Parties shall have recourse exclusively to the procedures established under Articles 408, 409 and 410. CHAPTER 7 ENVIRONMENT AND CLIMATE Article 390 Definitions 1. For the purposes of this Chapter, \"environmental levels of protection\" means the levels of protection provided overall in a Party's law which have the purpose of protecting the environment, including the prevention of a danger to human life or health from environmental impacts, including in each of the following areas: (a) industrial emissions; (b) air emissions and air quality; (c) nature and biodiversity conservation; (d) waste management; (e) the protection and preservation of the aquatic environment; (f) the protection and preservation of the marine environment; (g) the prevention, reduction and elimination of risks to human health or the environment arising from the production, use, release or disposal of chemical substances; or (h) the management of impacts on the environment from agricultural or food production, notably through the use of antibiotics and decontaminants. 2. For the Union, \"environmental levels of protection\" means environmental levels of protection that are applicable to and in, and are common to, all Member States. 3. For the purposes of this Chapter, \"climate level of protection\" means the level of protection with respect to emissions and removals of greenhouse gases and the phase-out of ozone depleting substances. With regard to greenhouse gases, this means: (a) for the Union, the 40 % economy-wide 2030 target, including the Union's system of carbon pricing; (b) for the United Kingdom, the United Kingdom's economy-wide share of this 2030 target, including the United Kingdom's system of carbon pricing. Article 391 Non-regression from levels of protection 1. The Parties affirm the right of each Party to set its policies and priorities in the areas covered by this Chapter, to determine the environmental levels of protection and climate level of protection it deems appropriate and to adopt or modify its law and policies in a manner consistent with each Party's international commitments, including those under this Chapter. 2. A Party shall not weaken or reduce, in a manner affecting trade or investment between the Parties, its environmental levels of protection or its climate level of protection below the levels that are in place at the end of the transition period, including by failing to effectively enforce its environmental law or climate level of protection. 3. The Parties recognise that each Party retains the right to exercise reasonable discretion and to make bona fide decisions regarding the allocation of environmental enforcement resources with respect to other environmental law and climate policies determined to have higher priorities, provided that the exercise of that discretion, and those decisions, are not inconsistent with its obligations under this Chapter. 4. For the purposes of this Chapter, insofar as targets are provided for in a Party's environmental law in the areas listed in Article 390, they are included in a Party's environmental levels of protection at the end of the transition period. These targets include those whose attainment is envisaged for a date that is subsequent to the end of the transition period. This paragraph shall also apply to ozone depleting substances. 5. The Parties shall continue to strive to increase their respective environmental levels of protection or their respective climate level of protection referred to in this Chapter. Article 392 Carbon pricing 1. Each Party shall have in place an effective system of carbon pricing as of 1 January 2021. 2. Each system shall cover greenhouse gas emissions from electricity generation, heat generation, industry and aviation. 3. The effectiveness of the Parties' respective carbon pricing systems shall uphold the level of protection provided for by Article 391. 4. By way of derogation from paragraph 2, aviation shall be included within two years at the latest, if not included already. The scope of the Union system of carbon pricing shall cover departing flights from the European Economic Area to the United Kingdom. 5. Each Party shall maintain its system of carbon pricing insofar as it is an effective tool for each Party in the fight against climate change and shall in any event uphold the level of protection provided for by Article 391. 6. The Parties shall cooperate on carbon pricing. They shall give serious consideration to linking their respective carbon pricing systems in a way that preserves the integrity of these systems and provides for the possibility to increase their effectiveness. Article 393 Environmental and climate principles 1. Taking into account the fact that the Union and the United Kingdom share a common biosphere in respect of cross-border pollution, each Party commits to respecting the internationally recognised environmental principles to which it has committed, such as in the Rio Declaration on Environment and Development, adopted at Rio de Janeiro on 14 June 1992 (the \"1992 Rio Declaration on Environment and Development\") and in multilateral environmental agreements, including in the United Nations Framework Convention on Climate Change, done at New York on 9 May 1992 (\"UNFCCC\") and the Convention on Biological Diversity, done at Rio de Janeiro on 5 June 1992 (the \"Convention on Biological Diversity\"), in particular: (a) the principle that environmental protection should be integrated into the making of policies, including through impact assessments; (b) the principle of preventative action to avert environmental damage; (c) the precautionary approach referred to in Article 356(2); (d) the principle that environmental damage should as a priority be rectified at source; and (e) the polluter pays principle. 2. The Parties reaffirm their respective commitments to procedures for evaluating the likely impact of a proposed activity on the environment, and where specified projects, plans and programmes are likely to have significant environmental, including health, effects, this includes an environmental impact assessment or a strategic environmental assessment, as appropriate. 3. These procedures shall comprise, where appropriate and in accordance with a Party's laws, the determination of the scope of an environmental report and its preparation, the carrying out of public participation and consultations and the taking into account of the environmental report and the results of the public participation and consultations in the consented project, or adopted plan or programme. Article 394 Enforcement 1. For the purposes of enforcement as referred to in Article 391, each Party shall, in accordance with its law, ensure that: (a) domestic authorities competent to enforce the relevant law with regard to environment and climate give due consideration to alleged violations of such law that come to their attention; those authorities shall have adequate and effective remedies available to them, including injunctive relief as well as proportionate and dissuasive sanctions, if appropriate; and (b) national administrative or judicial proceedings are available to natural and legal persons with a sufficient interest to bring actions against violations of such law and to seek effective remedies, including injunctive relief, and that the proceedings are not prohibitively costly and are conducted in a fair, equitable and transparent way. Article 395 Cooperation on monitoring and enforcement The Parties shall ensure that the European Commission and the supervisory bodies of the United Kingdom regularly meet with each other and co-operate on the effective monitoring and enforcement of the law with regard to environment and climate as referred to in Article 391. Article 396 Dispute settlement 1. The Parties shall make all efforts through dialogue, consultation, exchange of information and cooperation to address any disagreement on the application of this Chapter. 2. By way of derogation from Title I of Part Six, in the event of a dispute between the Parties regarding the application of this Chapter, the Parties shall have recourse exclusively to the procedures established under Articles 408, 409 and 410. CHAPTER 8 OTHER INSTRUMENTS FOR TRADE AND SUSTAINABLE DEVELOPMENT Article 397 Context and objectives 1. The Parties recall the Agenda 21 and the 1992 Rio Declaration on Environment and Development, the Johannesburg Plan of Implementation of the World Summit on Sustainable Development of 2002, the International Labour Organization (ILO) Declaration on Social Justice for a Fair Globalization, adopted at Geneva on 10 June 2008 by the International Labour Conference at its 97th Session (the \"2008 ILO Declaration on Social Justice for a Fair Globalization\"), the Outcome Document of the UN Conference on Sustainable Development of 2012 entitled \"The Future We Want\", endorsed by the UN General Assembly Resolution 66/288 adopted on 27 July 2012, and the UN 2030 Agenda for Sustainable Development, adopted by the UN General Assembly Resolution 70/1 on 25 September 2015 and its Sustainable Development Goals. 2. In light of paragraph 1 of this Article, the objective of this Chapter is to enhance the integration of sustainable development, notably its labour and environmental dimensions, in the Parties' trade and investment relationship and in this respect to complement the commitments of the Parties under Chapters 6 and 7. Article 398 Transparency 1. The Parties stress the importance of ensuring transparency as a necessary element to promote public participation and of making information public within the context of this Chapter. In accordance with their laws and regulations, the provisions of this Chapter, of Title IX and of Title X, each Party shall: (a) ensure that any measure of general application pursuing the objectives of this Chapter is administered in a transparent manner, including by providing the public with reasonable opportunities and sufficient time to comment, and by publishing such measures; (b) ensure that the general public is given access to relevant environmental information held by or for public authorities, as well as ensuring the active dissemination of that information to the general public by electronic means; (c) encourage public debate with and among non-state actors as regards the development and definition of policies that may lead to the adoption of law relevant to this Chapter by its public authorities; this includes, in relation to the environment, public participation in projects, plans and programmes; and (d) promote public awareness of its laws and standards relevant to this Chapter, as well as enforcement and compliance procedures, by taking steps to further the knowledge and understanding of the public; in relation to labour laws and standards, this includes workers, employers and their representatives. Article 399 Multilateral labour standards and agreements 1. The Parties affirm their commitment to promoting the development of international trade in a way that is conducive to decent work for all, as expressed in the 2008 ILO Declaration on Social Justice for a Fair Globalization. 2. In accordance with the ILO Constitution and the ILO Declaration on Fundamental Principles and Rights at Work and its Follow-up, adopted at Geneva on 18 June 1998 by the International Labour Conference at its 86th Session, each Party commits to respecting, promoting and effectively implementing the internationally recognised core labour standards, as defined in the fundamental ILO Conventions, which are: (a) freedom of association and the effective recognition of the right to collective bargaining; (b) the elimination of all forms of forced or compulsory labour; (c) the effective abolition of child labour; and (d) the elimination of discrimination in respect of employment and occupation. 3. Each Party shall make continued and sustained efforts to ratify the fundamental ILO Conventions if they have not yet done so. 4. The Parties shall exchange information, regularly and as appropriate, on the respective situations and progress of the Member States and of the United Kingdom with regard to the ratification of ILO Conventions or protocols classified as up-to-date by the ILO and of other relevant international instruments. 5. Each Party commits to implementing all the ILO Conventions that the United Kingdom and the Member States have respectively ratified and the different provisions of the European Social Charter that, as members of the Council of Europe, the Member States and the United Kingdom have respectively accepted (63). 6. Each Party shall continue to promote, through its laws and practices, the ILO Decent Work Agenda as set out in the 2008 ILO Declaration on Social Justice for a Fair Globalization (the \"ILO Decent Work Agenda\") and in accordance with relevant ILO Conventions, and other international commitments, in particular with regard to: (a) decent working conditions for all, with regard to, inter alia, wages and earnings, working hours, maternity leave and other conditions of work; (b) health and safety at work, including the prevention of occupational injury or illness and compensation in cases of such injury or illness; and (c) non-discrimination in respect of working conditions, including for migrant workers. 7. Each Party shall protect and promote social dialogue on labour matters among workers and employers, and their respective organisations, and with relevant government authorities. 8. The Parties shall work together on trade-related aspects of labour policies and measures, including in multilateral fora, such as the ILO, as appropriate. Such cooperation may cover inter alia: (a) trade-related aspects of implementation of fundamental, priority and other up-to-date ILO Conventions; (b) trade-related aspects of the ILO Decent Work Agenda, including on the interlinkages between trade and full and productive employment, labour market adjustment, core labour standards, decent work in global supply chains, social protection and social inclusion, social dialogue and gender equality; (c) the impact of labour law and standards on trade and investment, or the impact of trade and investment law on labour; (d) dialogue and information-sharing on the labour provisions in the context of their respective trade agreements, and the implementation thereof; and (e) any other form of cooperation deemed appropriate. 9. The Parties shall consider any views provided by representatives of workers, employers, and civil society organisations when identifying areas of cooperation and when carrying out cooperative activities. Article 400 Multilateral environmental agreements 1. The Parties recognise the importance of the UN Environment Assembly of the UN Environment Programme and of multilateral environmental governance and agreements as a response of the international community to global or regional environmental challenges and stress the need to enhance the mutual supportiveness between trade and environment policies, rules and measures. 2. In light of paragraph 1, each Party commits to effectively implementing the multilateral environmental agreements, protocols and amendments that it has ratified in its law and practices. 3. The Parties shall regularly and as appropriate exchange information on: (a) their respective situations as regards the ratification and implementation of multilateral environmental agreements, including their protocols and amendments; (b) on-going negotiations of new multilateral environmental agreements; and (c) each Party's respective views on becoming a party to additional multilateral environmental agreements. 4. The Parties reaffirm the right of each Party to adopt or maintain measures to further the objectives of multilateral environmental agreements to which it is party. The Parties recall that measures adopted or enforced to implement such multilateral environmental agreements may be justified under Article 412. 5. The Parties shall work together on trade-related aspects of environmental policies and measures, including in multilateral fora, such as the UN High-level Political Forum for Sustainable Development, the UN Environment Programme, the UN Environment Assembly, multilateral environmental agreements, the International Civil Aviation Organization (ICAO) or the WTO as appropriate. Such cooperation may cover inter alia: (a) initiatives on sustainable production and consumption, including those aimed at promoting a circular economy and green growth and pollution abatement; (b) initiatives to promote environmental goods and services, including by addressing related tariff and non-tariff barriers; (c) the impact of environmental law and standards on trade and investment; or the impact of trade and investment law on the environment; (d) the implementation of Annex 16 to the Convention on International Civil Aviation, done at Chicago on 7 December 1944, and other measures to reduce the environmental impact of aviation, including in the area of air traffic management; and (e) other trade-related aspects of multilateral environmental agreements, including their protocols, amendments and implementation. 6. Cooperation pursuant to paragraph 5 may include technical exchanges, exchanges of information and best practices, research projects, studies, reports, conferences and workshops. 7. The Parties will consider views or input from the public and interested stakeholders for the definition and implementation of their cooperation activities, and they may involve such stakeholders further in those activities, as appropriate. Article 401 Trade and climate change 1. The Parties recognise the importance of taking urgent action to combat climate change and its impacts, and the role of trade and investment in pursuing that objective, in line with the UNFCCC, with the purpose and goals of the Paris Agreement adopted at Paris on 12 December 2015 by the Conference of the Parties to the United Nations Framework Convention on Climate Change at its 21st session (the \"Paris Agreement\"), and with other multilateral environmental agreements and multilateral instruments in the area of climate change. 2. In light of paragraph 1, each Party: (a) commits to effectively implementing the UNFCCC, and the Paris Agreement of which one principal aim is strengthening the global response to climate change and holding the increase in the global average temperature to well below 2 oC above pre-industrial levels and pursuing efforts to limit the temperature increase to 1,5 oC above pre-industrial levels; (b) shall promote the mutual supportiveness of trade and climate policies and measures thereby contributing to the transition to a low greenhouse gas emission, resource-efficient economy and to climate-resilient development; and (c) shall facilitate the removal of obstacles to trade and investment in goods and services of particular relevance for climate change mitigation and adaptation, such as renewable energy, energy efficient products and services, for instance through addressing tariff and non-tariff barriers or through the adoption of policy frameworks conducive to the deployment of the best available solutions. 3. The Parties shall work together to strengthen their cooperation on trade-related aspects of climate change policies and measures bilaterally, regionally and in international fora, as appropriate, including in the UNFCCC, the WTO, the Montreal Protocol on Substances that Deplete the Ozone Layer done at Montreal on 26 August 1987 (the \"Montreal Protocol\"), the International Maritime Organisation (IMO) and the ICAO. Such cooperation may cover inter alia: (a) policy dialogue and cooperation regarding the implementation of the Paris Agreement, such as on means to promote climate resilience, renewable energy, low-carbon technologies, energy efficiency, sustainable transport, sustainable and climate-resilient infrastructure development, emissions monitoring, international carbon markets; (b) supporting the development and adoption of ambitious and effective greenhouse gas emissions reduction measures by the IMO to be implemented by ships engaged in international trade; (c) supporting the development and adoption of ambitious and effective greenhouse gas emissions reduction measures by the ICAO; and (d) supporting an ambitious phase-out of ozone depleting substances and phase-down of hydrofluorocarbons under the Montreal Protocol through measures to control their production, consumption and trade; the introduction of environmentally friendly alternatives to them; the updating of safety and other relevant standards as well as through combating the illegal trade of substances regulated by the Montreal Protocol. Article 402 Trade and biological diversity 1. The Parties recognise the importance of conserving and sustainably using biological diversity and the role of trade in pursuing these objectives, including by promoting sustainable trade or controlling or restricting trade in endangered species, in line with the relevant multilateral environmental agreements to which they are party, and the decisions adopted thereunder, notably the Convention on Biological Diversity and its protocols, and the Convention on International Trade in Endangered Species of Wild Fauna and Flora, done at Washington D.C. on 3 March 1973 (\"CITES\"). 2. In light of paragraph 1, each Party shall: (a) implement effective measures to combat illegal wildlife trade, including with respect to third countries, as appropriate; (b) promote the use of CITES as an instrument for conservation and sustainable management of biodiversity, including through the inclusion of animal and plant species in the Appendices to CITES where the conservation status of that species is considered at risk because of international trade; (c) encourage trade in products derived from a sustainable use of biological resources and contributing to the conservation of biodiversity; and (d) continue to take measures to conserve biological diversity when it is subject to pressures linked to trade and investment, in particular through measures to prevent the spread of invasive alien species. 3. The Parties shall work together on trade-related matters of relevance to this Article, including in multilateral fora, such as CITES and the Convention on Biological Diversity, as appropriate. Such cooperation may cover inter alia: trade in wildlife and natural resource-based products, the valuation and assessment of ecosystems and related services, and the access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation consistent with the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity, done at Nagoya on 29 October 2010. Article 403 Trade and forests 1. The Parties recognise the importance of conservation and sustainable forest management for providing environmental functions and economic and social opportunities for present and future generations, and the role of trade in pursuing that objective. 2. In light of paragraph 1 and in a manner consistent with its international obligations, each Party shall: (a) continue to implement measures to combat illegal logging and related trade, including with respect to third countries, as appropriate, and to promote trade in legally harvested forest products; (b) promote the conservation and sustainable management of forests and trade and consumption of timber and timber products harvested in accordance with the law of the country of harvest and from sustainably managed forests; and (c) exchange information with the other Party on trade-related initiatives on sustainable forest management, forest governance and on the conservation of forest cover and cooperate to maximise the impact and mutual supportiveness of their respective policies of mutual interest. 3. The Parties shall work together to strengthen their cooperation on trade-related aspects of sustainable forest management, the conservation of forest cover and illegal logging, including in multilateral fora, as appropriate. Article 404 Trade and sustainable management of marine biological resources and aquaculture 1. The Parties recognise the importance of conserving and sustainably managing marine biological resources and ecosystems as well as of promoting responsible and sustainable aquaculture, and the role of trade in pursuing those objectives. 2. In light of paragraph 1, each Party: (a) commits to acting consistently and complying, as appropriate, with the relevant UN and Food and Agriculture Organization (\"FAO\") agreements, the United Nations Convention on the Law of the Sea, the Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks, done at New York on 4 August 1995, the FAO Agreement to Promote Compliance with International Conservation and Management Measures by Fishing Vessels on the High Seas, done at Rome on 24 November 1993, the FAO Code of Conduct for Responsible Fisheries and the FAO Agreement on Port State Measures to Prevent, Deter and Eliminate Illegal, Unreported and Unregulated (\"IUU\") fishing, approved at Rome on 22 November 2009 at the 36th Session of the FAO Conference, and to participating in the FAO's initiative on the Global Record of Fishing Vessels, Refrigerated Transport Vessels and Supply Vessels; (b) shall promote sustainable fisheries and good fisheries governance by participating actively in the work of relevant international organisations or bodies to which they are members, observers, or cooperating non-contracting parties, including the Regional Fisheries Management Organizations (RFMOs) by means of, where applicable, effective monitoring, control or enforcement of the RFMOs' resolutions, recommendations or measures; the implementation of their catch documentation or certification schemes, and port state measures; (c) shall adopt and maintain their respective effective tools to combat IUU fishing, including measures to exclude the products of IUU fishing from trade flows, and cooperate to that end; and (d) shall promote the development of sustainable and responsible aquaculture, including with regard to the implementation of the objectives and principles contained in the FAO Code of Conduct for Responsible Fisheries, as appropriate. 3. The Parties shall work together on conservation and trade-related aspects of fishery and aquaculture policies and measures, including in the WTO, the RFMOs and other multilateral fora, as appropriate, with the aim of promoting sustainable fishing and aquaculture practices and trade in fish products from sustainably managed fisheries and aquaculture operations. 4. This Article is without prejudice to the provisions of Heading Five. Article 405 Trade and investment favouring sustainable development 1. The Parties confirm their commitment to enhancing the contribution of trade and investment to the goal of sustainable development in its economic, social and environmental dimensions. 2. Pursuant to paragraph 1, the Parties shall continue to promote: (a) trade and investment policies that support the four strategic objectives of the ILO Decent Work Agenda, consistent with the 2008 ILO Declaration on Social Justice for a Fair Globalization, including the minimum living wage, health and safety at work, and other aspects related to working conditions; (b) trade and investment in environmental goods and services, such as renewable energy and energy efficient products and services, including through addressing related non-tariff barriers or through the adoption of policy frameworks conducive to the deployment of the best available solutions; (c) trade in goods and services that contribute to enhanced social conditions and environmentally sound practices, including those subject to voluntary sustainability assurance schemes such as fair and ethical trade schemes and eco-labels; and (d) cooperation in multilateral fora on issues referred to in this Article. 3. The Parties recognise the importance of addressing specific sustainable development issues by reviewing, monitoring and assessing the potential economic, social and environmental impacts of possible actions, taking account of the views of stakeholders. Article 406 Trade and responsible supply chain management 1. The Parties recognise the importance of responsible management of supply chains through responsible business conduct and corporate social responsibility practices and the role of trade in pursuing this objective. 2. In light of paragraph 1, each Party shall: (a) encourage corporate social responsibility and responsible business conduct, including by providing supportive policy frameworks that encourage the uptake of relevant practices by businesses; and (b) support the adherence, implementation, follow-up and dissemination of relevant international instruments, such as the OECD Guidelines for Multinational Enterprises, the ILO Tripartite Declaration of Principles concerning Multinational Enterprises and Social Policy, the UN Global Compact, and the UN Guiding Principles on Business and Human Rights. 3. The Parties recognise the utility of international sector-specific guidelines in the area of corporate social responsibility and responsible business conduct and shall encourage joint work in this regard. In respect of the OECD Due Diligence Guidance for responsible supply chains of minerals from conflict-affected and high-risk areas and its supplements, the Parties shall also implement measures to promote the uptake of that Guidance. 4. The Parties shall work together to strengthen their cooperation on trade-related aspects of issues covered by this Article, including in multilateral fora, as appropriate, inter alia through the exchange of information, best practices and outreach initiatives. Article 407 Dispute settlement 1. The Parties shall make all efforts through dialogue, consultation, exchange of information and cooperation to address any disagreement on the application of this Chapter. 2. By way of derogation from Title I of Part Six, in the event of a dispute between the Parties regarding the application of this Chapter, the Parties shall have recourse exclusively to the procedures established under Articles 408 and 409. CHAPTER 9 HORIZONTAL AND INSTITUTIONAL PROVISIONS Article 408 Consultations 1. A Party may request consultations with the other Party regarding any matter arising under Article 355(3) and Chapters 6, 7, and 8 by delivering a written request to the other Party. The complaining Party shall specify in its written request the reasons and basis for the request, including identification of the measures at issue, specifying the provisions that it considers applicable. Consultations must commence promptly after a Party delivers a request for consultations and in any event not later than 30 days after the date of delivery of the request, unless the Parties agree to a longer period. 2. The Parties shall enter into consultations with the aim of reaching a mutually satisfactory resolution of the matter. During consultations, each Party shall provide the other Party with sufficient information in its possession to allow a full examination of the matters raised. Each Party shall endeavour to ensure the participation of personnel of their competent authorities who have expertise in the matter subject to the consultations. 3. In matters relating to Article 355(3) or to the multilateral agreements or instruments referred to in Chapters 6, 7 or 8 the Parties shall take into account available information from the ILO or relevant bodies or organisations established under multilateral environmental agreements. Where relevant, the Parties shall jointly seek advice from such organisations or their bodies, or any other expert or body they deem appropriate. 4. Each Party may seek, when appropriate, the views of the domestic advisory groups referred to in Article 13 or other expert advice. 5. Any resolution reached by the Parties shall be made available to the public. Article 409 Panel of experts 1. For any matter that is not satisfactorily addressed through consultations under Article 408, a Party may, after 90 days from the receipt of a request for consultations under that Article, request that a panel of experts be convened to examine that matter, by delivering a written request to the other Party. The request shall identify the measure at issue, specify and explain how that measure does not conform with the provisions of the relevant Chapter or Chapters in a manner sufficient to present the complaint clearly. 2. The panel of experts shall be composed of three panellists. 3. The Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development shall, at its first meeting after the entry into force of this Agreement, establish a list of at least 15 individuals who are willing and able to serve as panellists. Each Party shall name at least five individuals to the list to serve as panellists. The Parties shall also name at least five individuals who are not nationals of either Party and who are willing and able to serve as chairperson of a panel of experts. The Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development shall ensure that the list is kept up to date and that the number of experts is maintained at a minimum of 15 individuals. 4. The experts proposed as panellists must have specialised knowledge or expertise in labour or environmental law, other issues addressed in the relevant Chapter or Chapters, or in the resolution of disputes arising under international agreements. They must serve in their individual capacities and not take instructions from any organisation or government with regard to matters related to the dispute. They must not be affiliated with or take instructions from either Party. They shall not be persons who are members, officials or other servants of the Union institutions, of the Government of a Member State, or of the Government of the United Kingdom. 5. Unless the Parties agree otherwise within five days from the date of establishment of the panel of experts, the terms of reference shall be: \"to examine, in the light of the relevant provisions, the matter referred to in the request for the establishment of the panel of experts, and to deliver a report in accordance with this Article that makes findings on the conformity of the measure with the relevant provisions\". 6. In respect of matters related to multilateral standards or agreements covered in this Title, the panel of experts should seek information from the ILO or relevant bodies established under those agreements, including any pertinent available interpretative guidance, findings or decisions adopted by the ILO and those bodies. 7. The panel of experts may request and receive written submissions or any other information from persons with relevant information or specialised knowledge. 8. The panel of experts shall make available such information to each Party, allowing them to submit their comments within 20 days of its receipt. 9. The panel of experts shall issue to the Parties an interim report and a final report setting out the findings of fact, its determinations on the matter including as to whether the respondent Party has conformed with its obligations under the relevant Chapter or Chapters and the rationale behind any findings and determinations that it makes. For greater certainty, the Parties share the understanding that if the Panel makes recommendations in its report, the respondent Party does not need to follow these recommendations in ensuring conformity with this Agreement. 10. The panel of experts shall deliver to the Parties the interim report within 100 days after the date of establishment of the panel of experts. When the panel of experts considers that this deadline cannot be met, the chairperson of the panel of experts shall notify the Parties in writing, stating the reasons for the delay and the date on which the panel of experts plans to deliver its interim report. The panel of experts shall, under no circumstances, deliver its interim report later than 125 days after the date of establishment of the panel of experts. 11. Each Party may deliver to the panel of experts a reasoned request to review particular aspects of the interim report within 25 days of its delivery. A Party may comment on the other Party's request within 15 days of the delivery of the request. 12. After considering those comments, the panel of experts shall prepare the final report. If no request to review particular aspects of the interim report are delivered within the time period referred to in paragraph 11, the interim report shall become the final report of the panel of experts. 13. The panel of experts shall deliver its final report to the Parties within 175 days of the date of establishment of the panel of experts. When the panel of experts considers that this time limit cannot be met, its chairperson shall notify the Parties in writing, stating the reasons for the delay and the date on which the panel of experts plans to deliver its final report. The panel of experts shall, under no circumstances, deliver its final report later than 195 days after the date of establishment of the panel of experts. 14. The final report shall include a discussion of any written request by the Parties on the interim report and clearly address the comments of the Parties. 15. The Parties shall make the final report available to the public within 15 days of its delivery by the panel of experts. 16. If the final report of the panel of experts determines that a Party has not conformed with its obligations under the relevant Chapter or Chapters, the Parties shall, within 90 days of the delivery of the final report, discuss appropriate measures to be implemented taking into account the report of the panel of experts. No later than 105 days after the report has been delivered to the Parties, the respondent Party shall inform its domestic advisory groups established under Article 13 and the complaining Party of its decision on any measures to be implemented. 17. The Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development shall monitor the follow-up to the report of the panel of experts. The domestic advisory groups of the Parties established under Article 13 may submit observations to the Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development in that regard. 18. When the Parties disagree on the existence of, or the consistency with, the relevant provisions of any measure taken to address the non-conformity, the complaining Party may deliver a request, which shall be in writing, to the original panel of experts to decide on the matter. The request shall identify any measure at issue and explain how that measure is not in conformity with the relevant provisions in a manner sufficient to present the complaint clearly. The panel of experts shall deliver its findings to the Parties within 45 days of the date of the delivery of the request. 19. Except as otherwise provided for in this Article, Article 739(1), Article 740 and Articles 753 to 758, as well as Annexes 48 and 49, shall apply mutatis mutandis. Article 410 Panel of experts for non-regression areas 1. Article 409 shall apply to disputes between the Parties concerning the interpretation and application of Chapters 6 and 7. 2. For the purposes of such disputes, in addition to the Articles listed in Article 409(19), Articles 749 and 750 shall apply mutatis mutandis. 3. The Parties recognise that, where the respondent Party chooses not take any action to conform with the report of the panel of experts and with this Agreement, any remedies authorised under Article 749 continue to be available to the complaining Party. Article 411 Rebalancing 1. The Parties recognise the right of each Party to determine its future policies and priorities with respect to labour and social, environmental or climate protection, or with respect to subsidy control, in a manner consistent with each Party's international commitments, including those under this Agreement. At the same time, the Parties acknowledge that significant divergences in these areas can be capable of impacting trade or investment between the Parties in a manner that changes the circumstances that have formed the basis for the conclusion of this Agreement. 2. If material impacts on trade or investment between the Parties are arising as a result of significant divergences between the Parties in the areas referred to in paragraph 1, either Party may take appropriate rebalancing measures to address the situation. Such measures shall be restricted with respect to their scope and duration to what is strictly necessary and proportionate in order to remedy the situation. Priority shall be given to such measures as will least disturb the functioning of this Agreement. A Party's assessment of those impacts shall be based on reliable evidence and not merely on conjecture or remote possibility. 3. The following procedures shall apply to rebalancing measures taken under paragraph 2: (a) the concerned Party shall, without delay, notify the other Party through the Partnership Council of the rebalancing measures it intends to take, providing all relevant information. The Parties shall immediately enter into consultations. Consultations shall be deemed concluded within 14 days from the date of delivery of the notification, unless they are jointly concluded before that time limit; (b) if no mutually acceptable solution is found, the concerned Party may adopt rebalancing measures no sooner than five days from the conclusion of the consultations, unless the notified Party requests within the same five day period, in accordance with Article 739(2) (64), the establishment of an arbitration tribunal by means of a written request delivered to the other Party in order for the arbitration tribunal to decide whether the notified rebalancing measures are consistent with paragraph 2 of this Article; (c) the arbitration tribunal shall conduct its proceeding in accordance with Article 760 and deliver its final ruling within 30 days from its establishment. If the arbitration tribunal does not deliver its final ruling within that time period, the concerned Party may adopt the rebalancing measures no sooner than three days after the expiry of that 30 day time period. In that case, the other Party may take countermeasures proportionate to the adopted rebalancing measures until the arbitration tribunal delivers its ruling. Priority shall be given to such countermeasures as will least disturb the functioning of this Agreement. Point (a) shall apply mutatis mutandis to such countermeasures, which may be adopted no sooner than three days after the conclusion of consultations; (d) if the arbitration tribunal has found the rebalancing measures to be consistent with paragraph 2, the concerned Party may adopt the rebalancing measures as notified to the other Party; (e) if the arbitration tribunal has found the rebalancing measures to be inconsistent with paragraph 2 of this Article, the concerned Party shall, within three days from the delivery of the ruling, notify the complaining Party of the measures (65) it intends to adopt to comply with the ruling of the arbitration tribunal. Article 748(2) and Articles 749 (66) and 750 shall apply mutatis mutandis, if the complaining Party considers that the notified measures are not in compliance with the ruling of the arbitration tribunal. The procedures under Article 748(2) and Articles 749 and 750 shall have no suspensive effect on the application of the notified measures pursuant to this paragraph; (f) if rebalancing measures were adopted prior to the arbitration ruling in accordance with point (c), any countermeasures adopted pursuant to that point shall be withdrawn immediately, and in no case later than five days, after delivery of the ruling of the arbitration tribunal; (g) a Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from taking measures pursuant to paragraphs 2 and 3, including when those measures consist of suspension of obligations under this Agreement; (h) if the notified Party does not submit a request pursuant to point (b) of this paragraph within the time period laid down therein, that Party may without having prior recourse to consultations in accordance with Article 738 initiate the arbitration procedure referred to in Article 739. An arbitration tribunal shall treat the issue as a case of urgency for the purposes of Article 744. 4. In order to ensure an appropriate balance between the commitments made by the Parties in this Agreement on a more durable basis, either Party may request, no sooner than four years after the entry into force of this Agreement, a review of the operation of this Heading. The Parties may agree that other Headings of this Agreement may be added to the review. 5. Such a review shall commence at a Party's request, if that Party considers that measures under paragraph 2 or 3 have been taken frequently by either or both Parties, or if a measure that has a material impact on trade or investment between the Parties has been applied for a period of 12 months. For the purposes of this paragraph, the measures in question are those which were not challenged or not found by an arbitration tribunal to be strictly unnecessary pursuant to point (d) or (h) of paragraph 3. This review may commence earlier than four years after the entry into force of this Agreement. 6. The review requested pursuant to paragraph 4 or 5 shall begin within three months of the request and be completed within six months. 7. A review on the basis of paragraph 4 or 5 may be repeated at subsequent intervals of no less than four years after the conclusion of the previous review. If a Party has requested a review under paragraph 4 or 5, it may not request a further review under either paragraph 4 or 5 for at least four years from the conclusion of the previous review or, if applicable, from the entry into force of any amending agreement. 8. The review shall address whether this Agreement delivers an appropriate balance of rights and obligations between the Parties, in particular with regard to the operation of this Heading, and whether, as a result, there is a need for any modification of the terms of this Agreement. 9. The Partnership Council may decide that no action is required as a result of the review. If a Party considers that following the review there is a need for an amendment of this Agreement, the Parties shall use their best endeavours to negotiate and conclude an agreement making the necessary amendments. Such negotiations shall be limited to matters identified in the review. 10. If an amending agreement referred to in paragraph 9 is not concluded within one year from the date the Parties started negotiations, either Party may give notice to terminate this Heading or any other Heading of this Agreement that was added to the review, or the Parties may decide to continue negotiations. If a Party terminates this Heading, Heading Three shall be terminated on the same date. The termination shall take effect three months after the date of such notice. 11. If this Heading is terminated pursuant to paragraph 10 of this Article, Heading Two shall be terminated on the same date, unless the Parties agree to integrate the relevant parts of Title XI of this Heading in Heading Two. 12. Title I of Part Six does not apply to paragraphs 4 to 9 of this Article. TITLE XII EXCEPTIONS Article 412 General exceptions 1. Nothing in Chapter 1 and Chapter 5 of Title I, Chapter 2 of Title II, Title III, Title VIII and Chapter 4 of Title XI shall be construed as preventing a Party from adopting or maintaining measures compatible with Article XX of GATT 1994. To that end, Article XX of GATT 1994, including its Notes and Supplementary Provisions, is incorporated into and made part of this Agreement, mutatis mutandis. 2. Subject to the requirement that such measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where like conditions prevail, or a disguised restriction on investment liberalisation or trade in services, nothing in Title II, Title III, Title IV, Title VIII and Chapter 4 of Title XI shall be construed to prevent the adoption or enforcement by either Party of measures: (a) necessary to protect public security or public morals or to maintain public order (67); (b) necessary to protect human, animal or plant life or health; (c) necessary to secure compliance with laws or regulations which are not inconsistent with the provisions of this Agreement including those relating to: (i) the prevention of deceptive and fraudulent practices or to deal with the effects of a default on contracts; (ii) the protection of the privacy of individuals in relation to the processing and dissemination of personal data and the protection of confidentiality of individual records and accounts; and (iii) safety. 3. For greater certainty, the Parties understand that, to the extent that such measures are otherwise inconsistent with the provisions of the chapters or titles referred to in paragraphs 1 and 2 of this Article: (a) the measures referred to in point (b) of Article XX of GATT 1994 and in point (b) of paragraph 2 of this Article include environmental measures, which are necessary to protect human, animal or plant life and health; (b) point (g) of Article XX of GATT 1994 applies to measures relating to the conservation of living and non-living exhaustible natural resources; and (c) measures taken to implement multilateral environmental agreements can fall under points (b) or (g) of Article XX of GATT 1994 or under point (b) of paragraph 2 of this Article. 4. Before a Party takes any measures provided for in points (i) and (j) of Article XX of GATT 1994, that Party shall provide the other Party with all relevant information, with a view to seeking a solution acceptable to the Parties. If no agreement is reached within 30 days of providing the information, the Party may apply the relevant measures. Where exceptional and critical circumstances requiring immediate action make prior information or examination impossible, the Party intending to take the measures may apply forthwith precautionary measures necessary to deal with the situation. That Party shall inform the other Party immediately thereof. Article 413 Taxation 1. Nothing in Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of this Heading or Heading Six shall affect the rights and obligations of either the Union or its Member States and the United Kingdom, under any tax convention. In the event of any inconsistency between this Agreement and any such tax convention, the tax convention shall prevail to the extent of the inconsistency. With regard to a tax convention between the Union or its Member States and the United Kingdom, the relevant competent authorities under this Agreement and that tax convention shall jointly determine whether an inconsistency exists between this Agreement and the tax convention. (68) 2. Articles 130 and 138 shall not apply to an advantage accorded pursuant to a tax convention. 3. Subject to the requirement that tax measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where like conditions prevail, or a disguised restriction on trade and investment, nothing in Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of this Heading or Heading Six shall be construed to prevent the adoption, maintenance or enforcement by a Party of any measure that: (a) aims at ensuring the equitable or effective (69) imposition or collection of direct taxes; or (b) distinguishes between taxpayers, who are not in the same situation, in particular with regard to their place of residence or with regard to the place where their capital is invested. 4. For the purposes of this Article, the following definitions apply: (a) \"residence\" means residence for tax purposes; (b) \"tax convention\" means a convention for the avoidance of double taxation or any other international agreement or arrangement relating wholly or mainly to taxation; and (c) \"direct taxes\" comprise all taxes on income or capital, including taxes on gains from the alienation of property, taxes on estates, inheritances and gifts, taxes on wages or salaries paid by enterprises and taxes on capital appreciation. Article 414 WTO Waivers If an obligation in Titles I to XII of this Heading or Heading Six of this Part is substantially equivalent to an obligation contained in the WTO Agreement, any measure taken in conformity with a waiver adopted pursuant to Article IX of the WTO Agreement is deemed to be in conformity with the substantially equivalent provision in this Agreement. Article 415 Security exceptions Nothing in Titles I to XII of this Heading or Heading Six shall be construed: (a) to require a Party to furnish or allow access to any information the disclosure of which it considers contrary to its essential security interests; or (b) to prevent a Party from taking an action which it considers necessary for the protection of its essential security interests: (i) connected to the production of or traffic in arms, ammunition and implements of war and to such production, traffic and transactions in other goods and materials, services and technology, and to economic activities, carried out directly or indirectly for the purpose of supplying a military establishment; (ii) relating to fissionable and fusionable materials or the materials from which they are derived; or (iii) in time of war or other emergency in international relations; or (c) to prevent a Party from taking any action in pursuance of its obligations under the United Nations Charter for the maintenance of international peace and security. Article 416 Confidential information 1. With the exception of Article 384, nothing in Titles I to XII of this Heading or Heading Six of this Part shall be construed as requiring a Party to make available confidential information, the disclosure of which would impede law enforcement, or otherwise be contrary to the public interest, or which would prejudice the legitimate commercial interests of particular enterprises, public or private, except where an arbitration tribunal requires such confidential information in dispute settlement proceedings under Title I of Part Six, or where a panel of experts requires such confidential information in proceedings under Article 409 or 410. In such cases, the arbitration tribunal, or, as the case may be, the panel of experts shall ensure that confidentiality is fully protected in accordance with Annex 48. 2. When a Party submits information to the Partnership Council or to Committees that is considered as confidential under its laws and regulations, the other Party shall treat that information as confidential, unless the submitting Party agrees otherwise. HEADING TWO AVIATION TITLE I AIR TRANSPORT Article 417 Definitions For the purposes of this Title, the following definitions apply: (a) \"air carrier\" means an air transport undertaking holding a valid operating licence or equivalent; (b) \"air carrier of the Union\" means an air carrier that fulfils the conditions laid down in point (b) of Article 422(1); (c) \"air carrier of the United Kingdom\" means an air carrier that fulfils the conditions laid down in point (a) of Article 422(1) or Article 422(2); (d) \"air navigation services\" means air traffic services, communication, navigation and surveillance services, meteorological services for air navigation, and aeronautical information services; (e) \"air operator certificate\" means a document issued to an air carrier which affirms that the air carrier in question has the professional ability and organisation to secure the safe operation of aircraft for the aviation activities specified in the certificate; (f) \"air traffic management\" means the aggregation of the airborne and ground-based functions (air traffic services, airspace management and air traffic flow management) required to ensure the safe and efficient movement of aircraft during all phases of operations; (g) \"air transport\" means the carriage by aircraft of passengers, baggage, cargo, and mail, separately or in combination, held out to the public for remuneration or hire; (h) \"citizenship determination\" means a finding that an air carrier proposing to operate air services under this Title satisfies the requirements of Article 422 regarding its ownership, effective control and principal place of business; (i) \"competent authorities\" means, for the United Kingdom, the authorities of the United Kingdom responsible for the regulatory and administrative functions incumbent on the United Kingdom under this Title; and for the Union, the authorities of the Union and of the Member States responsible for the regulatory and administrative functions incumbent on the Union under this Title; (j) \"the Convention\" means the Convention on International Civil Aviation, done at Chicago on 7 December 1944, and includes: (i) any amendment that has entered into force under Article 94(a) of the Convention and has been ratified by the United Kingdom and the Member State or Member States concerned, as is relevant to the issue in question; and (ii) any Annex or any amendment thereto adopted under Article 90 of the Convention, insofar as such Annex or amendment is at any given time effective for the United Kingdom and the Member State or Member States concerned, as is relevant to the issue in question; (k) \"discrimination\" means differentiation of any kind without objective justification in respect of the supply of goods or services, including public services, employed for the operation of air transport services, or in respect of their treatment by public authorities relevant to such services; (l) \"effective control\" means a relationship constituted by rights, contracts or any other means which, either separately or jointly, and having regard to the considerations of fact or law involved, confer the possibility of directly or indirectly exercising a decisive influence on an undertaking, in particular by: (i) the right to use all or part of the assets of an undertaking; (ii) rights or contracts which confer a decisive influence on the composition, voting or decisions of the bodies of an undertaking or otherwise confer a decisive influence on the running of the business of the undertaking; (m) \"fitness determination\" means a finding that an air carrier proposing to operate air services under this Title has satisfactory financial capability and adequate managerial expertise to operate such services and is disposed to comply with the laws, regulations and requirements that govern the operation of such services; (n) \"full cost\" means the cost of the service provided, which may include appropriate amounts for cost of capital and depreciation of assets, as well as the costs of maintenance, operation, management and administration; (o) \"ICAO\" means the United Nations International Civil Aviation Organization; (p) \"principal place of business\" means the head office or registered office of an air carrier within which the principal financial functions and operational control, including continued airworthiness management, of that air carrier are exercised; (q) \"ramp inspection\" means an examination by the competent authority of a Party or its designated representatives, on board and around an aircraft of the other Party, to check both the validity of the relevant aircraft documents and those of its crew members and the apparent condition of the aircraft and its equipment; (r) \"self-handling\" means the performance of ground handling operations by an air carrier directly for itself or for another air carrier where: (i) one holds the majority in the other; or (ii) a single body has a majority holding in each; (s) \"scheduled air transport services\" means air services which are scheduled and performed for remuneration according to a published timetable, or which are so regular or frequent as to constitute a recognisably systematic series, and which are open to direct booking by members of the public; and extra section flights occasioned by overflow traffic from scheduled flights; (t) \"stop for non-traffic purposes\" means a landing for any purpose other than taking on board or discharging passengers, baggage, cargo and/or mail in air transport; (u) \"tariff\" means any fare, rate or charge for the carriage of passengers, baggage or cargo (excluding mail) in air transport (including any other mode of transport in connection therewith) charged by air carriers, including their agents, and the conditions governing the availability of such fare, rate or charge; (v) \"user charge\" means a charge imposed on air carriers for the provision of airport, air navigation (including overflights), aviation security facilities or services including related services and facilities, or environment-related charges including noise-related charges and charges to address local air quality problems at or around airports. Article 418 Route schedule 1. Subject to Article 419, the Union shall grant the United Kingdom the right for the air carriers of the United Kingdom to operate, while carrying out air transport, on the following routes: Points in the territory of the United Kingdom \u2013 Intermediate Points \u2013 Points in the territory of the Union \u2013 Points Beyond. 2. Subject to Article 419, the United Kingdom shall grant the Union the right for the air carriers of the Union to operate, while carrying out air transport, on the following routes: Points in the territory of the Union \u2013 Intermediate Points \u2013 Points in the territory of the United Kingdom \u2013 Points Beyond. Article 419 Traffic rights 1. Each Party shall grant to the other Party the right for its respective air carriers, for the purpose of carrying out air transport on the routes laid down in Article 418, to: (a) fly across its territory without landing; (b) make stops in its territory for non-traffic purposes. 2. The United Kingdom shall enjoy the right for its air carriers to make stops in the territory of the Union to provide scheduled and non-scheduled air transport services between any points situated in the territory of the United Kingdom and any points situated in the territory of the Union (third and fourth freedom traffic rights). 3. The Union shall enjoy the right for its air carriers to make stops in the territory of the United Kingdom to provide scheduled and non-scheduled air transport services between any points situated in the territory of the Union and any points situated in the territory of the United Kingdom (third and fourth freedom traffic rights). 4. Notwithstanding paragraphs 1, 2 and 3 and without prejudice to paragraph 9, the Member States and the United Kingdom may, subject to the respective internal rules and procedures of the Parties, enter into bilateral arrangements by which, as a matter of this Agreement, they grant each other the following rights: (a) for the United Kingdom, the right for its air carriers to make stops in the territory of the Member State concerned to provide scheduled and non-scheduled all-cargo air transport services, between points situated in the territory of that Member State and points situated in a third country as part of a service with origin or destination in the territory of the United Kingdom (fifth freedom traffic rights); (b) for the Member State concerned, the right for Union air carriers to make stops in the territory of the United Kingdom to provide scheduled and non-scheduled all-cargo air transport services between points situated in the territory of the United Kingdom and points situated in a third country, as part of a service with origin or destination in the territory of that Member State (fifth freedom traffic rights). 5. The rights mutually granted in accordance with paragraph 4 shall be governed by the provisions of this Title. 6. Neither Party shall unilaterally limit the volume of traffic, capacity, frequency, regularity, routing, origin or destination of the air transport services operated in accordance with paragraphs 2, 3 and 4, or the aircraft type or types operated for that purpose by the air carriers of the other Party, except as may be required for customs, technical, operational, air traffic management, safety, environmental or health protection reasons, in a non-discriminatory manner, or unless otherwise provided for in this Title. 7. Nothing in this Title shall be deemed to confer on the United Kingdom the right for its air carriers to take on board in the territory of a Member State passengers, baggage, cargo or mail carried for compensation and destined for another point in the territory of that Member State or any other Member State. 8. Nothing in this Title shall be deemed to confer on the Union the right for its air carriers to take on board in the territory of the United Kingdom passengers, baggage, cargo or mail carried for compensation and destined for another point in the territory of the United Kingdom. 9. Subject to the internal rules and procedures of the Parties, the competent authorities of the United Kingdom and of the Member States may authorise non-scheduled air transport services beyond the rights provided for in this Article provided that they do not constitute a disguised form of scheduled services, and may establish bilateral arrangements regarding the procedures to be followed for the handling of, and decisions on, air carriers' applications. Article 420 Code-share and blocked space arrangements 1. Air transport services in accordance with Article 419 may be provided by means of blocked-space or code-share arrangements, as follows: (a) an air carrier of the United Kingdom may act as the marketing carrier with any operating carrier that is an air carrier of the Union or an air carrier of the United Kingdom, or with any operating carrier of a third country which, under Union law or, as applicable, under the law of the Member State or Member States concerned, enjoys the necessary traffic rights as well as the right for its air carriers to exercise those rights by means of the arrangement in question; (b) an air carrier of the Union may act as the marketing carrier with any operating carrier that is an air carrier of the Union or an air carrier of the United Kingdom, or with any operating carrier of a third country which, under United Kingdom law enjoys the necessary traffic rights as well as the right for its air carriers to exercise those rights by means of the arrangement in question; (c) an air carrier of the United Kingdom may act as the operating carrier with any marketing carrier that is an air carrier of the Union or an air carrier of the United Kingdom, or with any marketing carrier of a third country which, under Union law or, as applicable, under the law of the Member State or Member States concerned, enjoys the necessary rights to enter into the arrangement in question; (d) an air carrier of the Union may act as the operating carrier with any marketing carrier that is an air carrier of the Union or an air carrier of the United Kingdom, or with any marketing carrier of a third country which, under United Kingdom law, enjoys the necessary rights to enter into the arrangement in question; (e) in the context of the arrangements provided under points (a) to (d), an air carrier of one Party may act as the marketing carrier in a blocked-space or code-share arrangement, in services between any pair of points of which both origin and destination are situated in the territory of the other Party provided that the following conditions are fulfilled: (i) the conditions laid down in point (a) or (b), as the case may be, as regards the operating carrier; and (ii) the transport service in question forms part of a carriage by the marketing carrier between a point in the territory of its Party and that destination point in the territory of the other Party. 2. An air carrier of one Party may act as the marketing carrier in a blocked-space or code-share arrangement, in services between any pair of points of which one is situated in the territory of the other Party and the other is situated in a third country, provided that the following conditions are fulfilled: (a) the conditions laid down in point (a) or (b) of paragraph 1, as the case may be, as regards the operating carrier; and (b) the transport service in question forms part of a carriage by the marketing carrier between a point in the territory of its Party and that point in a third country. 3. In respect of each ticket sold involving the arrangements referred to in this Article, the purchaser shall be informed upon reservation of which air carrier will operate each sector of the service. Where that is not possible, or in case of change after reservation, the identity of the operating carrier shall be communicated to the passenger as soon as it is established. In all cases, the identity of the operating carrier or carriers shall be communicated to the passenger at check-in, or before boarding where no check-in is required for a connecting flight. 4. The Parties may require the arrangements referred to in this Article to be approved by their competent authorities for the purpose of verifying compliance with the conditions set out therein and with other requirements provided for in this Agreement, in particular as regards competition, safety and security. 5. In no case shall recourse to code-share or blocked-space arrangements result in the air carriers of the Parties exercising traffic rights on the basis of this Agreement other than those provided for in Article 419. Article 421 Operational flexibility The rights mutually granted by the Parties in accordance with Article 419(2), (3) and (4) shall include, within the limits laid down therein, all of the following prerogatives: (a) to operate flights in either or both directions; (b) to combine different flight numbers within one aircraft operation; (c) to serve points in the route schedule in any combination and in any order; (d) to transfer traffic between aircraft of the same air carrier at any point (change of gauge); (e) to carry stopover traffic through any points whether within or outside the territory of either Party; (f) to carry transit traffic through the territory of the other Party; (g) to combine traffic on the same aircraft regardless of where such traffic originates; (h) to serve more than one point on the same service (co-terminalisation). Article 422 Operating authorisations and technical permissions 1. On receipt of an application for an operating authorisation from an air carrier of a Party, in the form and manner prescribed, to operate air transport services under this Title, the other Party shall grant the appropriate authorisations and technical permissions with minimum procedural delay, provided that all the following conditions are met: (a) in the case of an air carrier of the United Kingdom: (i) the air carrier is owned, directly or through majority ownership, and is effectively controlled by the United Kingdom, its nationals, or both; (ii) the air carrier has its principal place of business in the territory of the United Kingdom, and is licenced in accordance with the law of the United Kingdom; and (iii) the air carrier holds an air operator certificate issued by the competent authority of the United Kingdom, which shall be clearly identified, and that authority exercises and maintains effective regulatory control of the air carrier; (b) in the case of an air carrier of the Union: (i) the air carrier is owned, directly or through majority ownership, and is effectively controlled by one or more Member States, by other member states of the European Economic Area, by Switzerland, by nationals of such states, or by a combination thereof; (ii) the air carrier has its principal place of business in the territory of the Union and holds a valid operating licence in accordance with Union law; and (iii) the air carrier holds an air operator certificate issued by the competent authority of a Member State, or by a Union authority on its behalf, the certifying authority is clearly identified, and that Member State exercises and maintains effective regulatory control of the air carrier. (c) Articles 434 and 435 are being complied with, and (d) the air carrier meets the conditions prescribed under the laws and regulations normally applied to the operation of international air transport by the Party considering the application or applications. 2. Notwithstanding point (a)(i) of paragraph 1, the appropriate operating authorisations and permissions shall be granted to air carriers of the United Kingdom provided that all the following conditions are met: (a) the conditions laid down in points (a)(ii), (a)(iii), (c) and (d) of paragraph 1 are complied with; (b) the air carrier is owned, directly or through majority ownership, and is effectively controlled by one or more Member States, by other member states of the European Economic Area, by Switzerland, by nationals of such states, or by a combination thereof, whether alone or together with the United Kingdom and/or nationals of the United Kingdom; (c) on the day the transition period ended the air carrier held a valid operating licence in accordance with Union Law. 3. For the purposes of paragraphs 1 and 2, evidence of effective regulatory control includes but is not limited to: (a) the air carrier concerned holding a valid operating licence or permit issued by the competent authority and meeting the criteria of the Party issuing the operating licence or permit for the operation of international air services; and (b) that Party having and maintaining safety and security oversight programmes for that air carrier in compliance with ICAO standards. 4. When granting operating authorisations and technical permissions, each Party shall treat all air carriers of the other Party in a non-discriminatory manner. 5. On receipt of an application for an operating authorisation from an air carrier of a Party, the other Party shall recognise any fitness determination or citizenship determination or both made by the first Party with respect to that air carrier as if such determination had been made by its own competent authorities, and shall not enquire further into such matters, except as provided for in Article 424(3). Article 423 Operating plans, programmes and schedules Notification of operating plans, programmes or schedules for air services operated under this Title may be required by a Party for information purposes only. Where a Party requires such notification, it shall minimise the administrative burden associated with its notification requirements and procedures that is borne by air transport intermediaries and the air carriers of the other Party. Article 424 Refusal, revocation, suspension or limitation of operating authorisation 1. The Union may take action against an air carrier of the United Kingdom, in accordance with paragraphs 3, 4 and 5 of this Article, in any of the following cases: (a) in the case of authorisations and permissions granted in accordance with point (a) of Article 422(1), any of the conditions laid down therein is not met; (b) in the case of authorisations and permissions granted in accordance with Article 422(2), any of the conditions laid down therein is not met; (c) the air carrier has failed to comply with the laws and regulations referred to in Article 426; or (d) such action is necessary in order to prevent, protect against or control the spread of disease, or otherwise protect public health. 2. The United Kingdom may take action against an air carrier of the Union in accordance with paragraphs 3, 4 and 5 of this Article in any of the following cases: (a) any of the conditions laid down in point (b) of Article 422(1) is not met; (b) the air carrier has failed to comply with the laws and regulations referred to in Article 426; or (c) such action is necessary in order to prevent, protect against or control the spread of disease, or otherwise protect public health. 3. Where a Party has reasonable grounds to believe that an air carrier of the other Party is in any of the situations referred to in paragraph 1 or 2, as the case may be, and that action must be taken in that respect, that Party shall notify the other Party in writing as soon as possible of the reasons for the intended refusal, suspension or limitation of the operating authorisation or technical permission and request consultations. 4. Such consultations shall start as soon as possible, and not later than 30 days from receipt of the request for consultations. Failure to reach a satisfactory agreement within 30 days or an agreed time period from the starting date of such consultations, or failure to take the agreed corrective action, shall constitute grounds for the Party that requested the consultations to take action to refuse, revoke, suspend, impose conditions on or limit the operating authorisation or technical permissions of the air carrier or air carriers concerned to ensure compliance with Articles 422 and 426. Where measures have been taken to refuse, revoke, suspend or limit the operating authorisation or technical permission of an air carrier, a Party may have recourse to arbitration in accordance with Article 739, without having prior recourse to consultations in accordance with Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. At the request of a Party, the tribunal may, pending its final ruling, order the adoption of interim relief measures, including the modification or suspension of measures taken by either Party under this Article. 5. Notwithstanding paragraphs 3 and 4, in the cases referred to in points (c) and (d) of paragraph 1, and in points (b) and (c) of paragraph 2, a Party may take immediate or urgent action where required by an emergency or to prevent further non-compliance. For the purposes of this paragraph, further non-compliance means that the question of non-compliance has already been raised between the competent authorities of the Parties. 6. This Article is without prejudice to the provisions of Title XI of Heading One, Article 427(4), Article 434(4), (6) and (8) and Article 435(12) and to the dispute settlement procedure laid down in Title I of Part Six or to the measures resulting therefrom. Article 425 Ownership and control of air carriers The Parties recognise the potential benefits of the continued liberalisation of ownership and control of their respective air carriers. The Parties agree to examine in the Specialised Committee on Air Transport options for the reciprocal liberalisation of the ownership and control of their air carriers within 12 months from the entry into force of this Agreement, and thereafter within 12 months of receipt of a request to do so from one of the Parties. As a result of this examination, the Parties may decide to amend this Title. Article 426 Compliance with laws and regulations 1. The laws and regulations of a Party relating to the admission to, operation within, and departure from its territory of aircraft engaged in international air transport shall be complied with by the air carriers of the other Party while entering, operating within, or leaving the territory of that Party, respectively. 2. The laws and regulations of a Party relating to the admission to, operation within, or departure from its territory of passengers, crew, baggage, cargo, or mail on aircraft (including regulations relating to entry, clearance, immigration, passports, customs and quarantine, or in the case of mail, postal regulations) shall be complied with by, or on behalf of, such passengers, crew, baggage, cargo, and mail carried by the air carriers of the other Party while entering, operating within, or leaving the territory of that Party, respectively. 3. The Parties shall permit, in their respective territory, the air carriers of the other Party to take appropriate measures to ensure that only persons with the travel documents required for entry into or transit through the territory of the other Party are carried. Article 427 Non-Discrimination 1. Without prejudice to Title XI of Heading One, the Parties shall eliminate, within their respective jurisdictions, all forms of discrimination which would adversely affect the fair and equal opportunity of the air carriers of the other Party to compete in the exercise of the rights provided for in this Title. 2. A Party (the \"initiating Party\") may proceed in accordance with paragraphs 3 to 6 where it considers that its air carriers' fair and equal opportunities to compete in the exercise of the rights provided for in this Title are adversely affected by discrimination prohibited by paragraph 1. 3. The initiating Party shall submit a written request for consultations to the other Party (the \"responding Party\"). Consultations shall start within a period of 30 days from the receipt of the request, unless otherwise agreed by the Parties. 4. Where the initiating Party and the responding Party fail to reach agreement on the matter within 60 days from the receipt of the request for consultations referred to in paragraph 3, the initiating Party may take measures against all or part of the air carriers which have benefitted from discrimination prohibited by paragraph 1, including action to refuse, revoke, suspend, impose conditions on or limit the operating authorisations or technical permissions of the air carriers concerned. 5. The measures taken pursuant to paragraph 4 shall be appropriate, proportionate and restricted in their scope and duration to what is strictly necessary to mitigate the injury to the air carriers of the initiating Party and remove the undue advantage gained by the air carriers against which they are directed. 6. Where consultations have not resolved the matter or where measures have been taken pursuant to paragraph 4 of this Article, a Party may have recourse to arbitration in accordance with Article 739, without having prior recourse to consultations in accordance with Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. At the request of a Party, the tribunal may, pending its final ruling, order the adoption of interim relief measures, including the modification or suspension of measures taken by either Party under this Article. 7. Notwithstanding paragraph 2, the Parties shall not proceed under paragraphs 3 to 6 in relation to conduct falling under the scope of Title XI of Heading One. Article 428 Doing business 1. The Parties agree that obstacles to doing business encountered by air carriers would hamper the benefits under this Title. The Parties agree to cooperate in removing obstacles to doing business for air carriers of both Parties where such obstacles may hamper commercial operations, create distortions to competition or affect equal opportunities to compete. 2. The Specialised Committee on Air Transport shall monitor progress in effectively addressing matters relating to obstacles to doing business for air carriers. Article 429 Commercial operations 1. The Parties shall grant each other the rights laid down in paragraphs 2 to 7. For the purposes of the exercise of those rights, the air carriers of each Party shall not be required to retain a local sponsor. 2. As regards air carrier representatives: (a) the establishment of offices and facilities by the air carriers of one Party in the territory of the other Party as necessary to provide services under this Title shall be allowed without restriction or discrimination; (b) without prejudice to safety and security regulations, where such offices and facilities are located in an airport they may be subject to limitations on grounds of availability of space; (c) each Party shall, in accordance with its laws and regulations relating to entry, residence and employment, authorise the air carriers of the other Party to bring in and maintain in the territory of the authorising Party those of their own managerial, sales, technical, operational, and other specialist staff which the air carrier reasonably considers necessary for the provision of air transport services under this Title. Where employment authorisations are required for the personnel referred to in this paragraph, including those performing certain temporary duties, the Parties shall process applications for such authorisations expeditiously, subject to the relevant laws and regulations. 3. As regards ground handling: (a) each Party shall permit the air carriers of the other Party to perform self-handling in its territory without restrictions other than those based on considerations of safety or security, or otherwise resulting from physical or operational constraints; (b) each Party shall not impose on the air carriers of the other Party the choice of one or more providers of ground handling services among those which are present in the market in accordance with the laws and regulations of the Party where the services are provided; (c) without prejudice to point (a), where the laws and regulations of a Party limit or restrict in any way free competition between providers of ground handling services, that Party shall ensure that all necessary ground handling services are available to the air carriers of the other Party and that they are provided under no less favourable terms than those under which they are provided to any other air carrier. 4. As regards the allocation of slots at airports, each Party shall ensure that its regulations, guidelines and procedures for allocation of slots at the airports in its territory are applied in a transparent, effective, non-discriminatory and timely manner. 5. As regards local expenses and transfer of funds and earnings: (a) the provisions of Title IV of Heading One apply to the matters governed by this Title, without prejudice to Article 422; (b) the Parties shall grant each other the benefits laid down in points (c) to (e); (c) it shall be possible for the sale and purchase of transport and related services by the air carriers of the Parties, at the discretion of the air carrier, to be denominated in pounds sterling if the sale or purchase takes place in the territory of the United Kingdom, or, if the sale or purchase take place in the territory of a Member State, to be denominated in the currency of that Member State; (d) the air carriers of each Party shall be permitted to pay for local expenses in local currency, at their discretion; (e) the air carriers of each Party shall be permitted, on demand, to remit revenues obtained in the territory of the other Party from the sale of air transport services and associated activities directly linked to air transport in excess of sums locally disbursed, at any time, in any way, to the country of their choice. Prompt conversion and remittance shall be permitted without restrictions or taxation in respect thereof at the market rate of exchange applicable to current transactions and remittance on the date the carrier makes the initial application for remittance and shall not be subject to any charges except those normally made by banks for carrying out such conversion and remittance. 6. As regards intermodal transport: (a) in relation to the transport of passengers, the Parties shall not subject surface transport providers to laws and regulations governing air transport on the sole basis that such surface transport is held out by an air carrier under its own name; (b) subject to any conditions and qualifications set out in Title II of Heading One and its Annexes and in Title I of Heading Three and its Annex, air carriers of each Party shall be permitted, without restriction, to employ in connection with international air transport any surface transport for cargo to or from any points in the territories of the Parties, or in third countries, including transport to and from all airports with customs facilities, and including, where applicable, the right to transport cargo in bond under applicable laws and regulations. Such cargo, whether moving by surface or by air, shall have access to airport customs processing and facilities. Air carriers may elect to perform their own surface transport or to provide it through arrangements, including code share, with other surface transport providers, including surface transport operated by other air carriers and indirect providers of cargo air transport. Such inter-modal cargo services may be offered as a through service and at a single price for the air and surface transport combined, provided that shippers are informed as to the providers of the transport involved. 7. As regards leasing: (a) the Parties shall grant each other the right for their air carriers to provide air transport services in accordance with Article 419 in all the following ways: (i) using aircraft leased without crew from any lessor; (ii) in the case of air carriers of the United Kingdom, using aircraft leased with crew from other air carriers of the Parties; (iii) in the case of air carriers of the Union, using aircraft leased with crew from other air carriers of the Union; (iv) using aircraft leased with crew from air carriers other than those referred to in points (ii) and (iii), respectively, provided that the leasing is justified on the basis of exceptional needs, seasonal capacity needs or operational difficulties of the lessee, and the leasing does not exceed the duration which is strictly necessary to fulfil those needs or overcome those difficulties; (b) the Parties may require leasing arrangements to be approved by their competent authorities for the purpose of verifying compliance with the conditions set out in this paragraph and with the applicable safety and security requirements; (c) however, where a Party requires such approval, it shall endeavour to expedite the approval procedures and minimise the administrative burden on the air carriers concerned; (d) the provisions of this paragraph are without prejudice to the laws and regulations of a Party as regards the leasing of aircraft by air carriers of that Party. Article 430 Fiscal provisions 1. On arriving in the territory of one Party, aircraft operated in international air transport by the air carriers of the other Party, their regular equipment, fuel, lubricants, consumable technical supplies, ground equipment, spare parts (including engines), aircraft stores (including but not limited to such items as food, beverages and liquor, tobacco and other products destined for sale to, or use by, passengers in limited quantities during flight) and other items intended for or used solely in connection with the operation or servicing of aircraft engaged in international air transport shall, on the basis of reciprocity, and provided that such equipment and supplies remain on board the aircraft, be exempt from all import restrictions, property taxes and capital levies, customs duties, excise taxes, inspection fees, value added tax or other similar indirect taxes, and similar fees and charges imposed by the national or local authorities or the Union. 2. The following goods shall also be exempt, on the basis of reciprocity, from the taxes, levies, duties, fees and charges referred to in paragraph 1: (a) aircraft stores introduced into or supplied in the territory of a Party and taken on board, within reasonable limits, for use on outbound aircraft of an air carrier of the other Party used in international air transport, even when these stores are to be used on a part of the journey performed over the said territory; (b) ground equipment and spare parts (including engines) introduced into the territory of a Party for the servicing, maintenance, or repair of aircraft of an air carrier of the other Party used in international air transport; (c) lubricants and consumable technical supplies other than fuel introduced into or supplied in the territory of a Party for use in an aircraft of an air carrier of the other Party used in international air transport, even when those supplies are to be used on a part of the journey performed over the said territory; and (d) printed matter, as provided for by the customs legislation of each Party, introduced into or supplied in the territory of one Party and taken on board for use on outbound aircraft of an air carrier of the other Party engaged in international air transport, even when those stores are to be used on a part of the journey performed over the said territory. 3. The regular airborne equipment, as well as the material, supplies and spare parts referred to in paragraph 1 normally retained on board aircraft operated by an air carrier of one Party may be unloaded in the territory of the other Party only with the approval of the customs authorities of that Party and may be required to be kept under the supervision or control of the said authorities up to such time as they are re-exported or otherwise disposed of in accordance with applicable regulations. 4. The relief from customs duties, national excise duties and similar national fees provided for in this Article shall also be available in situations where the air carrier or air carriers of one Party have entered into arrangements with another air carrier or air carriers for the loan or transfer in the territory of the other Party of the items specified in paragraphs 1 and 2, provided that such other air carrier or air carriers similarly enjoy such relief from that other Party. 5. Nothing in this Title shall prevent either Party from imposing taxes, levies, duties, fees or charges on goods sold other than for consumption on board to passengers during a sector of an air service between two points within its territory at which embarkation or disembarkation is permitted. 6. Baggage and cargo in direct transit across the territory of a Party shall be exempt from taxes, customs duties, fees and other similar charges. 7. Equipment and supplies referred to in paragraph 2 may be required to be kept under the supervision or control of the competent authorities. 8. The provisions of the respective conventions in force between the United Kingdom and Member States for the avoidance of double taxation on income and on capital remain unaffected by this Title. 9. The relief from customs duties, national excise duties and similar national fees shall not extend to charges based on the cost of services provided to an air carrier of a Party in the territory of the other Party. Article 431 User charges 1. User charges that may be imposed by one Party on the air carriers of the other Party for the use of air navigation and air traffic control shall be cost-related and non-discriminatory. In any event, any such user charges shall be assessed on the air carriers of the other Party on terms not less favourable than the most favourable terms available to any other air carrier in like circumstances at the time the charges are applied. 2. Without prejudice to Article 429(5), each Party shall ensure that user charges other than those mentioned in paragraph 1 that may be imposed on the air carriers of the other Party are just, reasonable, not unjustly discriminatory, and equitably apportioned among categories of users. User charges imposed on the air carriers of the other Party may reflect, but not exceed, the full cost of providing appropriate airport, airport environmental and aviation security facilities and services at the airport or within the airport system. Such charges may include a reasonable return on assets after depreciation. Facilities and services for which user charges are imposed shall be provided on an efficient and economic basis. In any event, any such user charges shall be assessed on the air carrier of the other Party on terms no less favourable than the most favourable terms available to any other air carrier in like circumstances at the time the charges are applied. 3. In order to ensure the correct application of the principles set out in paragraphs 1 and 2, each Party shall ensure that consultations take place between the competent charging authorities or bodies in its territory and the air carriers using the services and facilities concerned and that the competent charging authorities or bodies and the air carriers exchange such information as may be necessary. Each Party shall ensure that the competent charging authorities provide users with reasonable notice of any proposal for changes in user charges to enable users to express their views before any changes are made. Article 432 Tariffs 1. The Parties shall allow tariffs to be freely established by the air carriers of the Parties on the basis of fair competition in accordance with this Title. 2. The Parties shall not subject the tariffs of each other's air carriers to approval. Article 433 Statistics 1. The Parties shall cooperate within the framework of the Specialised Committee on Air Transport to facilitate the exchange of statistical information related to air transport under this Title. 2. Upon request, each Party shall provide the other Party with non-confidential and non-commercially sensitive available statistics related to air transport under this Title, as required by the respective laws and regulations of the Parties, on a non-discriminatory basis, and as may reasonably be required. Article 434 Aviation safety 1. The Parties reaffirm the importance of close cooperation in the field of aviation safety. 2. Certificates of airworthiness, certificates of competency and licences issued or rendered valid by one Party and still in force shall be recognised as valid by the other Party and its competent authorities, for the purpose of operating air services under this Title, provided that such certificates or licences were issued or rendered valid pursuant to, and in conformity with, as a minimum, the relevant international standards established under the Convention. 3. Each Party may request consultations at any time concerning the safety standards maintained and administered by the other Party in areas relating to aeronautical facilities, flight crew, aircraft and the operation of aircraft. Such consultations shall take place within 30 days of the request. 4. If, following such consultations, one Party finds that the other Party does not effectively maintain and administer safety standards in the areas referred to in paragraph 2 that are at least equal to the minimum standards established at that time pursuant to the Convention, the first Party shall notify the other Party of those findings and the steps considered necessary to conform with those minimum standards, and the other Party shall take appropriate corrective action. Failure by the other Party to take appropriate action within 15 days or such other period as may be agreed shall be grounds for the requesting Party to refuse, revoke, suspend, impose conditions on or limit the operating authorisations or technical permissions, or to otherwise refuse, revoke, suspend, impose conditions on or limit the operations of the air carriers under the safety oversight of the other Party. 5. Any aircraft operated by, or, under a lease arrangement, on behalf of, an air carrier or air carriers of one Party may, while within the territory of the other Party, be made the subject of a ramp inspection, provided that this does not lead to unreasonable delay in the operation of the aircraft. 6. The ramp inspection or series of ramp inspections can give rise to: (a) serious concerns that an aircraft or the operation of an aircraft does not comply with the minimum standards established at that time pursuant to the Convention; or (b) serious concerns that there is a lack of effective maintenance and administration of safety standards established at that time pursuant to the Convention. In the event that the Party that conducted the ramp inspection or inspections establishes serious concerns as referred to in point (a) or (b), it shall notify the competent authorities of the other Party that are responsible for the safety oversight of the air carrier operating the aircraft of such findings and inform them of the steps considered necessary to conform with those minimum standards. Failure to take appropriate corrective action within 15 days or such other period as may be agreed shall constitute grounds for the first Party to refuse, revoke, suspend, impose conditions on or limit the operating authorisations or technical permissions or to otherwise refuse, revoke, suspend, impose conditions on or limit the operations of the air carrier operating the aircraft. 7. In the event that access for the purpose of undertaking a ramp inspection of an aircraft operated by the air carrier or air carriers of one Party in accordance with paragraph 5 is denied, the other Party shall be free to infer that serious concerns as referred to in paragraph 6 arise and proceed in accordance with paragraph 6. 8. Each Party reserves the right to immediately revoke, suspend or limit the operating authorisations or technical permissions or to otherwise suspend or limit the operations of an air carrier or air carriers of the other Party, if the first Party concludes as a result of a ramp inspection, a series of ramp inspections, a denial of access for ramp inspection, consultation or otherwise, that immediate action is essential to the safety of an air carrier operation. The Party taking such measures shall promptly inform the other Party, providing reasons for its action. 9. Any action by one Party in accordance with paragraph 4, 6 or 8 shall be discontinued once the basis for the taking of that action ceases to exist. 10. Where measures have been taken by a Party pursuant to paragraph 4, 6 or 8, in the event of a dispute a Party may have recourse to arbitration in accordance with Article 739, without having prior recourse to consultations in accordance with Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. At the request of the complaining Party, the tribunal may, pending its final ruling, order the adoption of interim relief measures, including the modification or suspension of measures taken by either Party under this Article. Article 435 Aviation security 1. The Parties shall provide upon request all necessary assistance to each other to address any threat to the security of civil aviation, including the prevention of acts of unlawful seizure of civil aircraft and other unlawful acts against the safety of such aircraft, of their passengers and crew, airports and air navigation facilities, and any other threat to the security of civil aviation. 2. The Parties shall, in their mutual relations, act in conformity with the aviation security standards established by ICAO. They shall require that operators of the aircraft in their registries and the operators of airports in their territory, act, at least, in conformity with such aviation security standards. Each Party shall, on request, provide the other Party notification of any difference between its laws, regulations and practices and the aviation security standards referred to in this paragraph. Each Party may at any time request consultations, to be held without delay, with the other Party to discuss those differences. 3. Each Party shall ensure that effective measures are taken within its territory to protect civil aviation against acts of unlawful interference, including, but not limited to, screening of passengers and their cabin baggage, screening of hold baggage, screening and security controls for persons other than passengers, including crew, and their items carried, screening and security controls for cargo, mail, in-flight and airport supplies, and access control to airside and security restricted areas. Each Party agrees that the security provisions of the other Party relating to the admission to, operating within, or departure from its territory of aircraft shall be observed. 4. The Parties shall endeavour to cooperate on aviation security matters to the highest extent, to exchange information on threat, vulnerability and risk, subject to the mutual agreement of appropriate arrangements for the secure transfer, use, storage and disposal of classified information, to discuss and share best practices, performance and detection standards of security equipment, compliance monitoring best practices and results, and in any other area that the Parties may identify. In particular, the Parties shall endeavour to develop and maintain cooperation arrangements between technical experts on the development and recognition of aviation security standards with the aim of facilitating such cooperation, reducing administrative duplication and fostering early notice and prior discussion of new security initiatives and requirements. 5. Each Party shall make available to the other Party on request the results of audits carried out by ICAO and the corrective actions taken by the audited state, subject to the mutual agreement of appropriate arrangements for the secure transfer, use, storage and disposal of such information. 6. The Parties agree to cooperate on security inspections undertaken by them in the territory of either Party through the establishment of mechanisms, including administrative arrangements, for the reciprocal exchange of information on results of such security inspections. The Parties agree to consider positively requests to participate, as observers, in security inspections undertaken by the other Party. 7. Subject to paragraph 9, and with full regard and mutual respect for the other Party's sovereignty, a Party may adopt security measures for entry into its territory. Where possible, that Party shall take into account the security measures already applied by the other Party and any views that the other Party may offer. Each Party recognises that nothing in this Article limits the right of a Party to refuse entry into its territory of any flight or flights that it deems to present a threat to its security. 8. A Party may take emergency measures to meet a specific security threat. Such measures shall be notified immediately to the other Party. Without prejudice to the need to take immediate action in order to protect aviation security, when considering security measures, a Party shall evaluate possible adverse effects on international air transport and, unless constrained by law, shall take such effects into account when it determines what measures are necessary and appropriate to address the security concerns. 9. With regard to air services bound for its territory, a Party may not require security measures to be implemented in the territory of the other Party. Where a Party considers that a specific threat urgently requires the implementation of temporary measures in addition to the measures already in place in the territory of the other Party, it shall, inform the other Party of the particulars of that threat to the extent consistent with the need to protect security information, and of the proposed measures. The other Party shall give positive consideration to such a proposal, and may decide to implement additional measures as it deems necessary. Such measures shall be proportionate and limited in time. 10. When an incident or threat of an incident of unlawful seizure of civil aircraft or other unlawful acts against the safety of aircraft, passengers, crew, airports or air navigation facilities occurs, the Parties shall assist each other by facilitating communications and other appropriate measures intended to rapidly and safely terminate such incident or threat. 11. Each Party shall take all measures it finds practicable to ensure that an aircraft subjected to an act of unlawful seizure or other acts of unlawful interference which is on the ground in its territory is detained on the ground unless its departure is necessitated by the overriding duty to protect human life. Where practicable, such measures shall be taken on the basis of consultations between the Parties. 12. When a Party has reasonable grounds to believe that the other Party does not comply with this Article, that Party may request immediate consultations with the other Party. Such consultations shall start within 30 days of the receipt of such a request. Failure to reach a satisfactory agreement within 15 days or such other period as may be agreed from the date of such request shall constitute grounds for the Party that requested the consultations to take action to refuse, revoke, suspend, impose conditions on or limit the operating authorisation and technical permissions of an air carrier or air carriers of the other Party to ensure compliance with this Article. When required by an emergency, or to prevent further non-compliance with this Article, a Party may take interim action prior to the expiry of the 15 day-period referred to in this paragraph. 13. Any action taken in accordance with paragraph 8 shall be discontinued when the Party in question considers that the action is no longer required or has been superseded by other measures to mitigate the threat. Any action taken in accordance with paragraph 12 shall be discontinued upon compliance by the other Party with this Article. In the case of action taken in accordance with paragraph 8 or 12, this may be discontinued as mutually agreed by the Parties. 14. Where measures or actions have been taken in accordance with paragraph 7, 8, 9 or 12 of this Article, a Party may have recourse to the dispute settlement provisions of Title I of Part Six. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. Article 436 Air traffic management 1. The Parties and their respective competent authorities and air navigation service providers shall cooperate with each other in such a way as to enhance the safe and efficient functioning of air traffic in the European region. The Parties shall seek interoperability between each other's service providers. 2. The Parties agree to cooperate on matters concerning the performance and charging of air navigation services and network functions, with a view to optimising overall flight efficiency, reducing costs, minimising environmental impact and enhancing the safety and capacity of air traffic flows between the existing air traffic management systems of the Parties. 3. The Parties agree to promote cooperation between their air navigation service providers in order to exchange flight data and coordinate traffic flows to optimise flight efficiency, with a view to achieving improved predictability, punctuality and service continuity for air traffic. 4. The Parties agree to cooperate on their air traffic management modernisation programmes, including research, development and deployment activities, and to encourage cross-participation in validation and demonstration activities with the goal of ensuring global interoperability. Article 437 Air carrier liability The Parties reaffirm their obligations under the Convention for the Unification of Certain Rules for International Carriage by Air, done at Montreal on 28 May 1999 (the \"Montreal Convention\"). Article 438 Consumer protection 1. The Parties share the objective of achieving a high level of consumer protection and shall cooperate to that effect. 2. The Parties shall ensure that effective and non-discriminatory measures are taken to protect the interests of consumers in air transport. Such measures shall include the appropriate access to information, assistance including for persons with disabilities and reduced mobility, reimbursement and, if applicable, compensation in case of denied boarding, cancellation or delays, and efficient complaint handling procedures. 3. The Parties shall consult each other on any matter related to consumer protection, including their planned measures in that regard. Article 439 Relationship to other agreements 1. Subject to paragraphs 4 and 5, earlier agreements and arrangements relating to the subject matter of this Title between the United Kingdom and the Member States, to the extent that they may not have been superseded by the law of the Union, shall be superseded by this Agreement. 2. The United Kingdom and a Member State may not grant each other any rights in connection with air transport to, from or within their respective territories other than those expressly laid down in this Title, save as provided for in Article 419(4) and (9). 3. If the Parties become party to a multilateral agreement, or endorse a decision adopted by ICAO or another international organisation that addresses matters covered by this Title, they shall consult in the Specialised Committee on Air Transport to determine whether this Title should be revised to take into account such developments. 4. Nothing in this Title shall affect the validity and application of existing and future air transport agreements between the Member States and the United Kingdom as regards territories under their respective sovereignty which are not covered by Article 774. 5. Nothing in this Title shall affect any rights available to the United Kingdom and Member States under the Multilateral Agreement on Commercial Rights of Non-Scheduled Air Services in Europe, signed at Paris on 30 April 1956, to the extent that such rights go beyond those laid down in this Title. Article 440 Suspension and Termination 1. A suspension of this Title, in whole or in part, pursuant to Article 749, may be implemented no earlier than the first day of the International Air Transport Association (IATA) traffic season following the season during which the suspension has been notified. 2. Upon termination of this Agreement pursuant to Article 779 or upon termination of this Title pursuant to Article 441 or Article 521 or Article 509, the provisions governing the matters falling within the scope of this Title shall continue to apply beyond the date of cessation referred to in Article 779 or Article 441 or Article 521 or Article 509, until the end of the IATA traffic season in progress on that date. 3. The Party suspending this Title, in whole or in part, or terminating this Agreement or this Title shall inform ICAO thereof. Article 441 Termination of this Title Without prejudice to Article 779, Article 521, and Article 509 each Party may at any moment terminate this Title, by written notification through diplomatic channels. In that event, this Title shall cease to be in force on the first day of the ninth month following the date of notification. Article 442 Registration of this Agreement This Agreement and any amendments thereto shall, insofar as relevant, be registered with ICAO in accordance with Article 83 of the Convention. TITLE II AVIATION SAFETY Article 443 Objectives The objectives of this Title are to: (a) enable the reciprocal acceptance, as provided for in the Annexes to this Title, of findings of compliance made and certificates issued by either Party's competent authorities or approved organisations; (b) promote cooperation toward a high level of civil aviation safety and environmental compatibility; (c) facilitate the multinational dimension of the civil aviation industry; (d) facilitate and promote the free flow of civil aeronautical products and services. Article 444 Definitions For the purposes of this Title, the following definitions apply: (a) \"approved organisation\" means any legal person certified by the competent authority of either Party to exercise privileges related to the scope of this Title; (b) \"certificate\" means any approval, licence or other document issued as a form of recognition of compliance that a civil aeronautical product, an organisation or a legal or natural person complies with the applicable requirements set out in laws and regulations of a Party; (c) \"civil aeronautical product\" means any civil aircraft, aircraft engine, or aircraft propeller, or subassembly, appliance, part or component, installed or to be installed thereon; (d) \"competent authority\" means a Union or government agency or a government entity responsible for civil aviation safety that is designated by a Party for the purposes of this Title to perform the following functions: (i) to assess the compliance of civil aeronautical products, organisations, facilities, operations and services subject to its oversight with applicable requirements set out in laws, regulations and administrative provisions of that Party; (ii) to conduct monitoring of their continued compliance with these requirements; and (iii) to take enforcement actions to ensure their compliance with these requirements; (e) \"findings of compliance\" means a determination of compliance with the applicable requirements set out in laws and regulations of a Party as the result of actions such as testing, inspections, qualifications, approvals and monitoring; (f) \"monitoring\" means the regular surveillance by a competent authority of a Party to determine continuing compliance with the applicable requirements set out in laws and regulations of that Party; (g) \"technical agent\" means, for the Union, the European Union Aviation Safety Agency (\"EASA\"), or its successor, and for the United Kingdom, the United Kingdom Civil Aviation Authority (\"CAA\"), or its successor; and (h) \"the Convention\" means the Convention on International Civil Aviation, done at Chicago on 7 December 1944, and includes: (i) any amendment that has entered into force under Article 94(a) of the Convention and has been ratified by the United Kingdom and the Member State or Member States concerned, as is relevant to the issue in question; and (ii) any Annex or any amendment thereto adopted under Article 90 of the Convention, insofar as such Annex or amendment is at any given time effective for the United Kingdom and the Member State or Member States concerned, as is relevant to the issue in question. Article 445 Scope and implementation 1. The Parties may cooperate in the following areas: (a) airworthiness certificates and monitoring of civil aeronautical products; (b) environmental certificates and testing of civil aeronautical products; (c) design and production certificates and monitoring of design and production organisations; (d) maintenance organisation certificates and monitoring of maintenance organisations; (e) personnel licensing and training; (f) flight simulator qualification evaluation; (g) operation of aircraft; (h) air traffic management and air navigation services; and (i) other areas related to aviation safety subject to Annexes to the Convention. 2. The scope of this Title shall be established by way of Annexes covering each area of cooperation set out in paragraph 1. 3. The Specialised Committee on Aviation Safety may only adopt Annexes as referred to in paragraph 2 where each Party has established that the civil aviation standards, rules, practices, procedures and systems of the other Party ensure a sufficiently equivalent level of safety to permit acceptance of findings of compliance made and certificates issued by its competent authorities or by organisations approved by those competent authorities. 4. Each Annex referred to in paragraph 2 shall describe the terms, conditions and methods for the reciprocal acceptance of findings of compliance and certificates, and, if necessary, transitional arrangements. 5. The technical agents may develop implementation procedures for each individual Annex. Technical differences between the Parties' civil aviation standards, rules, practices, procedures and systems shall be addressed in the Annexes referred to in paragraph 2 and implementation procedures. Article 446 General obligations 1. Each Party shall accept findings of compliance made and certificates issued by the other Party's competent authorities or approved organisations, in accordance with the terms and conditions set out in the Annexes referred to in Article 445(2). 2. Nothing in this Title shall entail reciprocal acceptance of the standards or technical regulations of the Parties. 3. Each Party shall ensure that its respective competent authorities remain capable and fulfil their responsibilities under this Title. Article 447 Preservation of regulatory authority Nothing in this Title shall be construed as limiting the authority of a Party to determine, through its legislative, regulatory and administrative measures, the level of protection it considers appropriate for safety and the environment. Article 448 Safeguard measures 1. Either Party may take all appropriate and immediate measures whenever it considers that there is a reasonable risk that a civil aeronautical product, a service or any activity that falls within the scope of this Title may compromise safety or the environment, may not meet its applicable legislative, regulatory or administrative measures, or may otherwise fail to satisfy a requirement within the scope of the applicable Annex to this Title. 2. Where either Party takes measures pursuant to paragraph 1, it shall inform the other Party in writing within 15 working days of taking such measures, providing reasons therefor. Article 449 Communication 1. The Parties shall designate and notify each other of a contact point for the communication related to the implementation of this Title. All such communications shall be in the English language. 2. The Parties shall notify to each other a list of the competent authorities, and thereafter an updated list each time that becomes necessary. Article 450 Transparency, regulatory cooperation and mutual assistance 1. Each Party shall ensure that the other Party is kept informed of its laws and regulations related to this Title and any significant changes to such laws and regulations. 2. The Parties shall to the extent possible inform each other of their proposed significant revisions of their relevant laws, regulations, standards, and requirements, and of their systems for issuing certificates insofar as these revisions may have an impact on this Title. To the extent possible, they shall offer each other an opportunity to comment on such revisions and give due consideration to such comments. 3. For the purpose of investigating and resolving specific safety issues, each Party's competent authorities may allow the other Party's competent authorities to participate as observers in each other's oversight activities as specified in the applicable Annex to this Title. 4. For the purpose of monitoring and inspections, each Party's competent authorities shall assist, if necessary, the other Party's competent authorities with the objective of providing unimpeded access to regulated entities subject to its oversight. 5. To ensure the continued confidence by each Party in the reliability of the other Party's processes for findings of compliance, each technical agent may participate as an observer in the other's oversight activities, in accordance with procedures set out in the Annexes to this Title. That participation shall not amount to a systematic participation in oversight activity of the other Party. Article 451 Exchange of safety information The Parties shall, without prejudice to Article 453 and subject to their applicable legislation: (a) provide each other, on request and in a timely manner, with information available to their technical agents related to accidents, serious incidents or occurrences in relation to civil aeronautical products, services or activities covered by the Annexes to this Title; and (b) exchange other safety information as the technical agents may agree. Article 452 Cooperation in enforcement activities The Parties shall, through their technical agents or competent authorities, provide when requested, subject to applicable laws and regulations, as well as to the availability of required resources, mutual cooperation and assistance in investigations or enforcement activities regarding any alleged or suspected violation of laws or regulations falling within the scope of this Title. In addition, each Party shall promptly notify the other Party of any investigation when mutual interests are involved. Article 453 Confidentiality and protection of data and information 1. Each Party shall, in accordance with its laws and regulations, maintain the confidentiality of data and information received from the other Party under this Title. Such data and information may only be used by the Party receiving the data and information for the purposes of this Title. 2. In particular, subject to their respective laws and regulations, the Parties shall neither disclose to a third party, including the public, nor permit their competent authorities to disclose to a third party, including the public, any data and information received from the other Party under this Title that constitutes trade secrets, intellectual property, confidential commercial or financial information, proprietary data, or information that relates to an ongoing investigation. To that end, such data and information shall be considered to be confidential. 3. A Party or a competent authority of a Party may, upon providing data or information to the other Party or a competent authority of the other Party, designate data or information that it considers to be confidential and not to be subject to disclosure. In that case, the Party or its competent authority shall clearly mark such data or information as confidential. 4. If a Party disagrees with the designation made by the other Party or a competent authority of that Party in accordance with paragraph 3, the former Party may request consultations with the other Party to address the issue. 5. Each Party shall take all reasonable precautions necessary to protect data and information, received under this Title, from unauthorised disclosure. 6. The Party receiving data and information from the other Party under this Title shall not acquire any proprietary rights on such data and information by reason of its receipt from the other Party. Article 454 Adoption and amendments of Annexes to this Title The Specialised Committee on Aviation Safety may amend Annex 30, adopt or amend Annexes as provided for in Article 445(2) and delete any Annex. Article 455 Cost recovery Each Party shall endeavour to ensure that any fees or charges imposed by a Party or its technical agent on a legal or natural person whose activities are covered by this Title shall be just, reasonable and commensurate with the services provided, and shall not create a barrier to trade. Article 456 Other agreements and prior arrangements 1. Upon entry into force of this Agreement, this Title shall supersede any bilateral aviation safety agreements or arrangements between the United Kingdom and the Member States with respect to any matter covered by this Title that has been implemented in accordance with Article 445. 2. The technical agents shall take necessary measures to revise or terminate, as appropriate, prior arrangements between them. 3. Subject to paragraphs 1 and 2, nothing in this Title shall affect the rights and obligations of the Parties under any other international agreements. Article 457 Suspension of reciprocal acceptance obligations 1. A Party shall have the right to suspend, in whole or in part, its acceptance obligations under Article 446(1), when the other Party materially violates its obligations under this Title. 2. Before exercising its right to suspend its acceptance obligations, a Party shall request consultations for the purpose of seeking corrective measures of the other Party. During the consultations, the Parties shall, where appropriate, consider the effects of the suspension. 3. Rights under this Article shall be exercised only if the other Party fails to take corrective measures within an appropriate period of time following the consultations. If a Party exercises a right under this Article, it shall notify the other Party of its intention to suspend the acceptance obligations in writing and detail the reasons for suspension. 4. Such suspension shall take effect 30 days after the date of the notification, unless, prior to the end of that period, the Party which initiated the suspension notifies the other Party in writing that it is withdrawing its notification. 5. Such suspension shall not affect the validity of findings of compliance made and certificates issued by the competent authorities or approved organisations of the other Party prior to the date the suspension took effect. Any such suspension that has become effective may be rescinded immediately upon an exchange of diplomatic notes to that effect by the Parties. Article 458 Termination of this Title Without prejudice to Article 779, Article 521 and Article 509, each Party may at any moment terminate this Title, by written notification through diplomatic channels. In that event, this Title shall cease to be in force on the first day of the ninth month following the date of notification. HEADING THREE ROAD TRANSPORT TITLE I TRANSPORT OF GOODS BY ROAD Article 459 Objective 1. The objective of this Title is to ensure, as regards the transport of goods by road, continued connectivity between, through and within the territories of the Parties and to lay down the rules which are applicable to such transport. 2. The Parties agree not to take discriminatory measures when applying this Title. 3. Nothing in this Title shall affect the transport of goods by road within the territory of one of the Parties by a road haulage operator established in that territory. Article 460 Scope 1. This Title applies to the transport of goods by road with a commercial purpose between, through and within the territories of the Parties and is without prejudice to the application of the rules established by the European Conference of Ministers of Transport. 2. Any transport of goods by road for which no direct or indirect remuneration is received and which does not directly or indirectly generate any income for the driver of the vehicle or for others, and which is not linked to professional activity shall be considered as the transport of goods for a non-commercial purpose. Article 461 Definitions For the purposes of this Title and in addition to the definitions set out in Article 124, the following definitions apply: (a) \"vehicle\" means a motor vehicle registered in the territory of a Party, or a coupled combination of vehicles of which the motor vehicle is registered in the territory of a Party, and which is used exclusively for the transport of goods; (b) \"road haulage operator\" means any natural or legal person engaged in the transport of goods with a commercial purpose, by means of a vehicle; (c) \"road haulage operator of a Party\" means a road haulage operator which is a legal person established in the territory of a Party or a natural person of a Party; (d) \"party of establishment\" means the Party in which a road haulage operator is established; (e) \"driver\" means any person who drives a vehicle even for a short period, or who is carried in a vehicle as part of his duties to be available for driving if necessary; (f) \"transit\" means the movement of vehicles across the territory of a Party without loading or unloading of goods; (g) \"regulatory measures\" means: (i) for the Union: (A) regulations and directives, as provided for in Article 288 TFEU; and (B) delegated and implementing acts, as provided for in Articles 290 and 291 TFEU, respectively; and (ii) for the United Kingdom: (A) primary legislation; and (B) secondary legislation. Article 462 Transport of goods between, through and within the territories of the Parties 1. Provided that the conditions in paragraph 2 are fulfilled, road haulage operators of a Party may undertake: (a) laden journeys with a vehicle, from the territory of the Party of establishment to the territory of the other Party, and vice versa, with or without transit through the territory of a third country; (b) laden journeys with a vehicle from the territory of the Party of establishment to the territory of the same Party with transit through the territory of the other Party; (c) laden journeys with a vehicle to or from the territory of the Party of establishment with transit through the territory of the other Party; (d) unladen journeys with a vehicle in conjunction with the journeys referred to in points (a), (b) and (c). 2. Road haulage operators of a Party may only undertake a journey referred to in paragraph 1 if: (a) they hold a valid licence issued in accordance with Article 463, except in the cases referred to in Article 464; and (b) the journey is carried out by drivers who hold a Certificate of Professional Competence in accordance with Article 465(1). 3. Subject to paragraph 6, and provided that the conditions in paragraph 2 are fulfilled, road haulage operators of the United Kingdom may undertake up to two laden journeys from one Member State to another Member State, without returning to the territory of the United Kingdom, provided that such journeys follow a journey from the territory of the United Kingdom permitted under point (a) of paragraph 1. 4. Without prejudice to paragraph 5, subject to paragraph 6 and provided that the conditions in paragraph 2 are fulfilled, road haulage operators of the United Kingdom may undertake one laden journey within the territory of a Member State provided that operation: (a) follows a journey from the territory of the United Kingdom permitted under point (a) of paragraph 1; and (b) is performed within seven days of the unloading in the territory of that Member State of goods carried on the journey referred to in point (a). 5. Subject to paragraph 6 and provided that the conditions in paragraph 2 are fulfilled, road haulage operators of the United Kingdom established in Northern Ireland may undertake up to two laden journeys within the territory of Ireland provided that such operations: (a) follow a journey from the territory of Northern Ireland permitted under point (a) of paragraph 1; and (b) are performed within seven days of the unloading in the territory of Ireland of goods carried on the journey referred to in point (a). 6. Road haulage operators of the United Kingdom shall be limited to a maximum of two journeys within the territory of the Union under paragraphs 3, 4 and 5 before returning to the territory of the United Kingdom. 7. Provided that the conditions in paragraph 2 are fulfilled, road haulage operators of the Union may undertake up to two laden journeys within the territory of the United Kingdom provided that such operations: (a) follow a journey from the territory of the Union permitted under point (a) of paragraph 1; and (b) are performed within seven days of the unloading in the territory of the United Kingdom of the goods carried on the journey referred to in point (a). Article 463 Requirements for operators 1. Road haulage operators of a Party undertaking a journey referred to in Article 462 shall hold a valid licence issued in accordance with paragraph 2 of this Article. 2. Licences shall only be issued, in accordance with the law of the Parties, to road haulage operators who comply with the requirements set out in Section 1 of Part A of Annex 31 governing the admission to, and the pursuit of, the occupation of road haulage operator. 3. A certified true copy of the licence shall be kept on board the vehicle and shall be presented at the request of any inspecting officers authorised by each Party. The licence and the certified true copies shall correspond to one of the models set out in Appendix 31-A-1-3 of Part A to Annex 31, which also lays down the conditions governing its use. The licence shall contain at least two of the security features listed in Appendix 31-A-1-4 to Part A of Annex 31. 4. Road haulage operators shall comply with the requirements set out in Section 2 of Part A of Annex 31 laying down requirements for the posting of drivers when undertaking a journey referred to in Article 462(3) to (7). Article 464 Exemptions from licencing requirement The following types of transport of goods and unladen journeys made in conjunction with such transport may be conducted without a valid licence as referred to in Article 463: (a) transport of mail as a universal service; (b) transport of vehicles which have suffered damage or breakdown; (c) until 20 May 2022, transport of goods in motor vehicles the permissible laden mass of which, including that of trailers, does not exceed 3,5 tonnes; (d) from 21 May 2022, transport of goods in motor vehicles the permissible laden mass of which, including that of trailers, does not exceed 2,5 tonnes; (e) transport of medicinal products, appliances, equipment and other articles required for medical care in emergency relief, in particular for natural disasters and humanitarian assistance; (f) transport of goods in vehicles provided that the following conditions are fulfilled: (i) the goods carried are the property of the road haulage operator or have been sold, bought, let out on hire or hired, produced, extracted, processed or repaired by the operator; (ii) the purpose of the journey is to carry the goods to or from the road haulage operator's premises or to move them, either inside or outside the operator for its own requirements; (iii) the vehicles used for such transport are driven by personnel employed by, or put at the disposal of, the road haulage operator under a contractual obligation; (iv) the vehicles carrying the goods are owned by the road haulage operator, have been bought by it on deferred terms or have been hired; and (v) such transport is no more than ancillary to the overall activities of the road haulage operator; (g) transport of goods by means of motor vehicles with a maximum authorised speed not exceeding 40 km/h. Article 465 Requirements for drivers 1. Drivers of the vehicles undertaking journeys as referred to in Article 462 shall: (a) hold a Certificate of Professional Competence issued in accordance with Section 1 of Part B of Annex 31; and (b) comply with the rules on driving and working time, rest periods, breaks and the use of tachographs in accordance with Sections 2 to 4 of Part B of Annex 31. 2. The European Agreement concerning the Work of Crews of Vehicles Engaged in International Road Transport (AETR), done in Geneva on 1 July 1970, shall apply, instead of point (b) of paragraph 1, to international road transport operations undertaken in part outside the territory of the Parties, for the whole journey. Article 466 Requirements for vehicles 1. A Party shall not reject or prohibit the use in its territory of a vehicle undertaking a journey referred to in Article 462 if the vehicle complies with the requirements set out in Section 1 of Part C of Annex 31. 2. Vehicles undertaking the journeys referred to in Article 462 shall be equipped with a tachograph constructed, installed, used, tested and controlled in accordance with Section 2 of Part C of Annex 31. Article 467 Road traffic rules Drivers of vehicles undertaking the transport of goods under this Title shall, when in the territory of the other Party, comply with the national laws and regulations in force in that territory concerning road traffic. Article 468 Development of laws and Specialised Committee on Road Transport 1. When a Party proposes a new regulatory measure in an area covered by Annex 31, it shall: (a) notify the other Party of the proposed regulatory measure as soon as possible; and (b) keep the other Party informed of progress of the regulatory measure. 2. At the request of one of the Parties, an exchange of views shall take place within the Specialised Committee on Road Transport no later than two months after the submission of the request, as to whether the proposed new regulatory measure would apply to journeys referred to in Article 462, or not. 3. When a Party adopts a new regulatory measure referred to in paragraph 1, it shall notify the other Party, and supply the text of the new regulatory measure within one week of its publication. 4. The Specialised Committee on Road Transport shall meet to discuss any new regulatory measure adopted, on request by either Party within two months of the submission of the request, whether or not a notification has taken place in accordance with paragraph 1 or 3, or a discussion has taken place in accordance with paragraph 2. 5. The Specialised Committee on Road Transport may: (a) amend Annex 31 to take account of regulatory and/or technological developments, or to ensure the satisfactory implementation of this Title; (b) confirm that the amendments made by the new regulatory measure conform to Annex 31; or (c) decide on any other measure aimed at safeguarding the proper functioning of this Title. Article 469 Remedial measures 1. If a Party considers that the other Party has adopted a new regulatory measure that does not comply with the requirements of Annex 31, in particular in cases where the Specialised Committee on Road Transport has not reached a decision under Article 468, and the other Party nevertheless applies the provisions of the new regulatory measure to the Party's road transport operators, drivers or vehicles, the Party may, after notifying the other Party, adopt appropriate remedial measures, including the suspension of obligations under this Agreement or any supplementing Agreement, provided that such measures: (a) do not exceed the level equivalent to the nullification or impairment caused by the new regulatory measure adopted by the other Party that does not comply with the requirements of Annex 31; and (b) take effect at the earliest 7 days after the Party which intends to take such measures has given the other Party notice under this paragraph. 2. The appropriate remedial measures shall cease to apply: (a) when the Party having taken such measures is satisfied that the other Party is complying with its obligations under this Title; or (b) in compliance with a ruling of the arbitration tribunal. 3. A Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from suspending obligations under this Article. Article 470 Taxation 1. Vehicles used for the carriage of goods in accordance with this Title shall be exempt from the taxes and charges levied on the possession or circulation of vehicles in the territory of the other Party. 2. The exemption referred to in paragraph 1 shall not apply to: (a) a tax or charge on fuel consumption; (b) a charge for using a road or network of roads; or (c) a charge for using particular bridges, tunnels or ferries. 3. The fuel contained in the standard tanks of the vehicles and of special containers, admitted temporarily, which is used directly for the purpose of propulsion and, where appropriate, for the operation, during transport, of refrigeration systems and other systems, as well as lubricants present in the motor vehicles and required for their normal operation during the journey, shall be free of custom duties and any other taxes and levies, such as VAT and excise duties, and shall not be subject to any import restrictions. 4. The spare parts imported for repairing a vehicle on the territory of one Party that has been registered or put into circulation in the other Party, shall be admitted under cover of a temporary duty-free admission and without prohibition or restriction of importation. The replaced parts are subject to customs duties and other taxes (VAT) and shall be re-exported or destroyed under the control of the customs authorities of the other Party. Article 471 Obligations in other Titles Articles 135 and 137 are incorporated into and made part of this Title and apply to the treatment of road haulage operators undertaking journeys in accordance with Article 462. Article 472 Termination of this Title Without prejudice to Article 779, Article 521 and Article 509, each Party may at any moment terminate this Title, by written notification through diplomatic channels. In that event, this Title shall cease to be in force on the first day of the ninth month following the date of notification. TITLE II TRANSPORT OF PASSENGERS BY ROAD Article 473 Scope 1. The objective of this Title is to ensure, as regards the transport of passengers by road, continued connectivity between, through and within the territories of the Parties and to lay down the rules which are applicable to such transport. It applies to the occasional, regular and special regular transport of passengers by coach and bus between, through and within the territories of the Parties. 2. The Parties agree not to take discriminatory measures when applying this Title. 3. Nothing in this Title shall affect the transport of passengers within the territory of one of the Parties by a road passenger transport operator established in that territory. Article 474 Definitions For the purposes of this Title and in addition to the definitions set out in Article 124, the following definitions apply: (a) \"coaches and buses\" are vehicles which, by virtue of their construction and their equipment, are suitable for carrying more than nine persons, including the driver, and are intended for that purpose; (b) \"passenger transport services\" means transport services by road for the public or for specific categories of users, supplied in return for payment by the person transported or by the transport organiser, by means of coaches and buses; (c) \"road passenger transport operator\" means any natural person or any legal person, whether having its own legal personality or being dependent upon an authority having such a personality, which supplies passenger transport services; (d) \"road passenger transport operator of a Party\" means a road passenger transport operator which is established in the territory of a Party; (e) \"regular services\" means passenger transport services supplied at specified frequency along specified routes, whereby passengers may be picked up and set down at predetermined stopping points; (f) \"special regular services\" means services by whomsoever organised, which provide for the transport of specified categories of passengers to the exclusion of other passengers, in so far as such services are operated under the conditions specified for regular services. Special regular services shall include: (i) the transport of workers between home and work, and (ii) the transport of school pupils and students to and from the educational institution. The fact that a special regular service may be varied according to the needs of users shall not affect its classification as a regular service; (g) \"group\" means any of the following: (i) one or more associated natural or legal persons and their parent natural or legal person or persons, (ii) one or more associated natural person or legal persons which have the same parent natural or legal person or persons; (h) \"Interbus Agreement\" means the Agreement on the international occasional carriage of passengers by coach and bus, as subsequently amended, which entered into force on 1 January 2003; (i) \"transit\" means the movement of coaches and buses across the territory of a Party without picking up or setting down of passengers; (j) \"occasional services\" means services which are not regular services or special regular services, and which are characterised above all by the fact that they carry groups of passengers assembled at the initiative of the customer or the road passenger transport operator. Article 475 Passenger transport by coach and bus between, through and within the territories of the Parties 1. Road passenger transport operators of a Party may, when operating regular and special regular services, undertake laden journeys from the territory of a Party to the territory of the other Party, with or without transit through the territory of a third country, and unladen journeys related to such journeys. 2. Road passenger transport operators of a Party may, when operating regular and special regular services, undertake laden journeys from the territory of the Party, in which the road passenger transport operator is established, to the territory of the same Party with transit through the territory of the other Party, and unladen journeys related to such journeys. 3. A road passenger transport operator of a Party may not operate regular or special regular services with both origin and destination in the territory of the other Party. 4. Where the passenger transport service referred to in paragraph 1 is part of a service to or from the territory of the Party where the road passenger transport operator is established, passengers may be picked up or set down in the territory of the other Party en route, provided the stop is authorised in accordance with the rules applicable in that territory. 5. Where the passenger transport service referred to in this Article is part of an international regular or special regular service between Ireland and the United Kingdom in respect of Northern Ireland, passengers may be picked up and set down in one Party by a road passenger transport operator established in the other Party. 6. Road passenger transport operators established in the territory of one Party may, on a temporary basis, operate occasional services on the island of Ireland which pick up and set down passengers on the territory of the other Party. 7. Road passenger transport operators may, when operating occasional services, undertake a laden journey from the territory of a Party through the territory of the other Party to the territory of a non-Contracting Party to the Interbus Agreement, including a related unladen journey. 8. The passenger transport services referred to in this Article shall be performed using coaches and buses registered in the Party where the road passenger transport operator is established or resides. Those coaches and buses shall comply with the technical standards laid down in Annex 2 to the Interbus Agreement. Article 476 Conditions for the provision of services referred to in Article 475 1. Regular services shall be open to all road passenger transport operators of a Party, subject to compulsory reservation, where appropriate. 2. Regular and special regular services shall be subject to authorisation in accordance with Article 477, and paragraph 6 of this Article. 3. The regular nature of the service shall not be affected by any adjustment to the service operating conditions. 4. The organisation of parallel or temporary services, serving the same public as existing regular services, the non-serving of certain stops and the serving of additional stops on existing regular services shall be governed by the same rules as those applicable to existing regular services. 5. Sections V (Social provisions) and VI (Custom and fiscal provisions) of the Interbus Agreement as well as Annexes 1 (Conditions applying to road passenger transport operators) and 2 (Technical standards applying to buses and coaches) thereto shall apply. 6. For a period of six months from the date of entry into force of this Agreement, special regular services shall not be subject to authorisation where they are covered by a contract concluded between the organiser and the road passenger transport operator. 7. Occasional services covered by this Title in accordance with Article 475 shall not require authorisation. However, the organisation of parallel or temporary services comparable to existing regular services and serving the same public as the latter shall be subject to authorisation in accordance with Section VIII of the Interbus Agreement. Article 477 Authorisation 1. Authorisations for services referred to in Article 475 shall be issued by the competent authority of the Party in whose territory the road passenger transport operator is established (the \"authorising authority\"). 2. If a road passenger transport operator is established in the Union, the authorising authority shall be the competent authority of the Member State of origin or destination. 3. In the case of a group of road passenger transport operators intending to operate a service referred to in Article 475, the authorising authority shall be the competent authority to which the application is addressed in accordance with the second subparagraph of Article 478(1). 4. Authorisations shall be issued in the name of the road passenger transport operator and shall be non-transferable. However, a road passenger transport operator of a Party who has received an authorisation may, with the consent of the authorising authority, operate the service through a subcontractor, if such a possibility is in line with the law of the Party. In this case, the name of the subcontractor and its role shall be indicated in the authorisation. The subcontractor shall be a road passenger transport operator of a Party and shall comply with all the provisions of this Title. In the case of a group of road passenger transport operators that intend to operate services referred to in Article 475, the authorisation shall be issued in the names of all the road passenger transport operators of the group and shall state the names of all those operators. It shall be given to the road passenger transport operators entrusted by the other road passenger transport operators of a Party for these purposes and which has requested it, and certified true copies shall be given to the other road passenger transport operators. 5. Without prejudice to Article 479(3), the period of validity of an authorisation shall not exceed five years. It may be set for a shorter period either at the request of the applicant or by mutual consent of the competent authorities of the Parties on whose territories passengers are picked up or set down. 6. Authorisations shall specify the following: (a) the type of service; (b) the route of the service, giving in particular the point of departure and the point of arrival; (c) the period of validity of the authorisation; and (d) the stops and the timetable. 7. Authorisations shall conform to the model set out in Annex 32. 8. The road passenger transport operator of a Party carrying out a service referred to in Article 475 may use additional vehicles to deal with temporary and exceptional situations. Such additional vehicles may be used only under the same conditions as set out in the authorisation referred to in paragraph 6 of this Article. In this case, in addition to the documents referred to in Article 483(1) and (2), the road passenger transport operator shall ensure that a copy of the contract between the road passenger transport operator carrying out the regular or special regular service and the undertaking providing the additional vehicles or an equivalent document is carried in the vehicle and presented at the request of any authorised inspecting officer. Article 478 Submission of application for authorisation 1. Applications for authorisation shall be submitted by the road passenger transport operator of a Party to the authorising authority referred to in Article 477(1). For each service, only one application shall be submitted. In the cases referred to in Article 477(3), it shall be submitted by the operator entrusted by the other operators for these purposes. The application shall be addressed to the authorising authority of the Party in which the road passenger transport operator submitting it is established. 2. Applications for authorisation shall be submitted on the basis of the model set out in Annex 33. 3. The road passenger transport operator applying for authorisation shall provide any further information which it considers relevant or which is requested by the authorising authority, in particular, the documents listed in Annex 33. Article 479 Authorisation procedure 1. Authorisations shall be issued in agreement with the competent authorities in the Parties in whose territory passengers are picked up or set down. The authorising authority shall forward to such competent authorities, as well as to the competent authorities whose territories are crossed without passengers being picked up or set down, a copy of the application, together with copies of any other relevant documentation, and its assessment. In respect of the Union, the competent authorities referred to in the first subparagraph shall be those of the Member States in whose territories passengers are picked up or set down and whose territories are crossed without passengers being picked up or set down. 2. The competent authorities whose agreement has been requested shall notify the authorising authority of their decision regarding the application within four months. This time limit shall be calculated from the date of receipt of the request for agreement which is shown in the acknowledgement of receipt. If the decision received from the competent authorities whose agreement has been requested is negative, it shall contain a proper statement of reasons. If the authorising authority does not receive a reply within four months, the competent authorities consulted shall be deemed to have given their agreement and the authorising authority may grant the authorisation. The competent authorities whose territory is crossed without passengers being picked up or set down may notify the authorising authority of their comments within four months. 3. In respect of services that had been authorised under Regulation (EC) No 1073/2009 of the European Parliament and the Council (70) before the end of the transition period and in respect of which the authorisation lapses at the end of the transition period, the following shall apply: (a) where, subject to the changes necessary to comply with Article 475, the operating conditions are the same as those having been set in the authorisation granted under Regulation (EC) No 1073/2009, the relevant authorising authority under this Title may, on application or otherwise, issue the road transport operator with a corresponding authorisation granted under this Title. Where such an authorisation is issued, the agreement of the competent authorities in whose territories passengers are picked up or set down, as referred to in paragraph 2, shall be deemed to be provided. Those competent authorities and the competent authorities whose territory is crossed without passengers being picked up or set down may, at any time, notify the authorising authority of any comments they may have; (b) where point (a) is applied, the validity period of the corresponding authorisation granted under this Title shall not extend beyond the last day of the validity period specified in the authorisation previously granted under Regulation (EC) No 1073/2009. 4. The authorising authority shall take a decision on the application no later than six months from the date of submission of the application by the road passenger transport operator. 5. Authorisation shall be granted unless: (a) the applicant is unable to provide the service which is the subject of the application with equipment directly available to the applicant; (b) the applicant has not complied with national or international legislation on road transport, and in particular the conditions and requirements relating to authorisations for international road passenger services, or has committed serious infringements of a Party's road transport legislation in particular with regard to the rules applicable to vehicles and driving and rest periods for drivers; (c) in the case of an application for renewal of authorisation, the conditions of authorisation have not been complied with; (d) a Party decides on the basis of a detailed analysis that the service concerned would seriously affect the viability of a comparable service covered by one or more public service contracts conforming to the Party's law on the direct sections concerned. In such a case, the Party shall set up criteria, on a non-discriminatory basis, for determining whether the service applied for would seriously affect the viability of the abovementioned comparable service and shall communicate them to the other Party referred to in paragraph 1; or (e) a Party decides on the basis of a detailed analysis that the principal purpose of the service is not to carry passengers between stops located in the territories of the Parties. In the event that an existing service seriously affects the viability of a comparable service covered by one or more public service contracts which conform to a Party's law on the direct sections concerned, due to exceptional reasons which could not have been foreseen at the time of granting the authorisation, a Party may, with the agreement of the other Party, suspend or withdraw the authorisation to run the international coach and bus service after having given six months' notice to the road passenger transport operator. The fact that a road passenger transport operator of a Party offers lower prices than those offered by other road passenger transport operators or the fact that the link in question is already operated by other road passenger transport operators shall not in itself constitute justification for rejecting the application. 6. Having completed the procedure laid down in paragraphs 1 to 5, the authorising authority shall grant the authorisation or formally refuse the application. Decisions rejecting an application shall state the reasons on which they are based. The Parties shall ensure that transport undertakings are given the opportunity to make representations in the event of their application being rejected. The authorising authority shall inform the competent authorities of the other Party of its decision and shall send them a copy of any authorisation. Article 480 Renewal and alteration of authorisation 1. Article 479 shall apply, mutatis mutandis, to applications for the renewal of authorisations or for alteration of the conditions under which the services subject to authorisation must be carried out. 2. Where the existing authorisation expires within six months from the date of entry into force of this Agreement, the period of time in which the competent authorities referred to in Article 479(2) shall notify the authorising authority of their agreement to, or comments on, the application in accordance with that Article, is two months. 3. In the event of a minor alteration to the operating conditions, in particular the adjustment of intervals, fares and timetables, the authorising authority needs only supply the competent authorities of the other Party with information relating to the alteration. Changing the timetables or intervals in a manner that affects the timing of controls at the borders between the Parties or at third country borders shall not be considered a minor alteration. Article 481 Lapse of an authorisation 1. Without prejudice to Article 479(3), an authorisation for a service referred to in Article 475 shall lapse at the end of its period of validity or three months after the authorising authority has received notice from its holder of his or her intention to withdraw the service. Such notice shall contain a proper statement of reasons. 2. Where demand for a service has ceased to exist, the period of notice provided for in paragraph 1 shall be one month. 3. The authorising authority shall inform the competent authorities of the other Party concerned that the authorisation has lapsed. 4. The holder of the authorisation shall notify users of the service concerned of its withdrawal one month in advance by means of appropriate publicity. Article 482 Obligations of transport operators 1. Save in the event of force majeure, the road passenger transport operator of a Party carrying out a service referred to in Article 475 shall launch the service without delay and, until the authorisation expires, take all measures to guarantee a transport service that fulfils the standards of continuity, regularity and capacity and complies with the conditions specified in accordance with Article 477(6) and Annex 32. 2. The road passenger transport operator of a Party shall display the route of the service, the bus stops, the timetable, the fares and the conditions of carriage in such a way as to ensure that such information is readily available to all users. 3. It shall be possible for the Parties to make changes to the operating conditions governing a service referred to in Article 475 by common agreement and in agreement with the holder of the authorisation. Article 483 Documents to be kept on the coach or bus 1. Without prejudice to Article 477(8), the authorisation or a certified true copy thereof to carry out services referred to in Article 475 and the operator's licence of the road passenger transport operator or a certified true copy thereof for the international carriage of passengers by road provided for according to national or Union law shall be kept on the coach or bus and shall be presented at the request of any authorised inspecting officer. 2. Without prejudice to paragraph 1 of this Article as well as to Article 477(8), in the case of a special regular service, the contract between the organiser and the road passenger transport operator or a copy thereof as well as a document evidencing that the passengers constitute a specific category to the exclusion of other passengers for the purposes of a special regular service shall also serve as control documents, shall be kept in the vehicle and shall be presented at the request of any authorised inspecting officer. 3. Road passenger transport operators carrying out occasional services under Article 475(6) and (7) shall carry a completed journey form, using the model set out in Annex 34. Books of journey forms shall be supplied by the competent authority of the territory in which the operator is registered, or by bodies appointed by the competent authority. Article 484 Road traffic rules Drivers of coaches and buses undertaking the transport of passengers under this Title shall, when in the territory of the other Party, comply with the national laws and regulations in force in that territory concerning road traffic. Article 485 Application The provisions of this Title shall cease to apply as of the date the Protocol to the Interbus Agreement regarding the international regular and special regular carriage of passengers by coach and bus enters into force for the United Kingdom, or six months following the entry into force of that Protocol for the Union, whichever is the earliest, except for the purpose of the operations under Article 475(2), (5), (6) and (7). Article 486 Obligations in other Titles Articles 135 and 137 are incorporated into and made part of this Title and apply to the treatment of transport operators undertaking journeys in accordance with Article 475. Article 487 Specialised Committee The Specialised Committee on Road Transport may amend Annexes 32, 33 and 34 to take into account regulatory developments. It may adopt measures regarding the implementation of this Title. HEADING FOUR SOCIAL SECURITY COORDINATION AND VISAS FOR SHORT-TERM VISITS TITLE I SOCIAL SECURITY COORDINATION Article 488 Overview Member States and the United Kingdom shall coordinate their social security systems in accordance with the Protocol on Social Security Coordination, in order to secure the social security entitlements of the persons covered therein. Article 489 Legally residing 1. The Protocol on Social Security Coordination applies to persons legally residing in a Member State or the United Kingdom. 2. Paragraph 1 of this Article shall not affect entitlements to cash benefits which relate to previous periods of legal residence of persons covered by Article SSC.2 of the Protocol on Social Security Coordination. Article 490 Cross-border situations 1. The Protocol on Social Security Coordination only applies to situations arising between one or more Member States and the United Kingdom. 2. The Protocol on Social Security Coordination shall not apply to persons whose situations are confined in all respects either to the United Kingdom, or to the Member States. Article 491 Immigration applications The Protocol on Social Security Coordination applies without prejudice to the right of a Member State or the United Kingdom to charge a health fee under national legislation in connection with an application for a permit to enter, to stay, to work, or to reside in that State. TITLE II VISAS FOR SHORT-TERM VISITS Article 492 Visas for short-term visits 1. The Parties note that on the date of entry into force of this Agreement both Parties provide for visa-free travel for short-term visits in respect of their nationals in accordance with their domestic law. Each Party shall notify the other of any intention to impose a visa requirement for short-term visits by nationals of the other Party in good time and, if possible, at least three months before such a requirement takes effect. 2. Subject to paragraph 3 of this Article and to Article 781, in the event that the United Kingdom decides to impose a visa requirement for short-term visits on nationals of a Member State, that requirement shall apply to the nationals of all Member States. 3. This Article is without prejudice to any arrangements made between the United Kingdom and Ireland concerning the Common Travel Area. HEADING FIVE FISHERIES CHAPTER 1 INITIAL PROVISIONS Article 493 Sovereign rights of coastal States exercised by the Parties The Parties affirm that sovereign rights of coastal States exercised by the Parties for the purpose of exploring, exploiting, conserving and managing the living resources in their waters should be conducted pursuant to and in accordance with the principles of international law, including the United Nations Convention on the Law of the Sea. Article 494 Objectives and principles 1. The Parties shall cooperate with a view to ensuring that fishing activities for shared stocks in their waters are environmentally sustainable in the long term and contribute to achieving economic and social benefits, while fully respecting the rights and obligations of independent coastal States as exercised by the Parties. 2. The Parties share the objective of exploiting shared stocks at rates intended to maintain and progressively restore populations of harvested species above biomass levels that can produce the maximum sustainable yield. 3. The Parties shall have regard to the following principles: (a) applying the precautionary approach to fisheries management; (b) promoting the long-term sustainability (environmental, social and economic) and optimum utilisation of shared stocks; (c) basing conservation and management decisions for fisheries on the best available scientific advice, principally that provided by the International Council for the Exploration of the Sea (ICES); (d) ensuring selectivity in fisheries to protect juvenile fish and spawning aggregations of fish, and to avoid and reduce unwanted bycatch; (e) taking due account of and minimising harmful impacts of fishing on the marine ecosystem and taking due account of the need to preserve marine biological diversity; (f) applying proportionate and non-discriminatory measures for the conservation of marine living resources and the management of fisheries resources, while preserving the regulatory autonomy of the Parties; (g) ensuring the collection and timely sharing of complete and accurate data relevant for the conservation of shared stocks and for the management of fisheries; (h) ensuring compliance with fisheries conservation and management measures, and combating illegal, unreported and unregulated fishing; and (i) ensuring the timely implementation of any agreed measures into the Parties' regulatory frameworks. Article 495 Definitions 1. For the purposes of this Heading, the following definitions apply: (a) \"EEZ\" (of a Party) means, in accordance with the United Nations Convention on the Law of the Sea: (i) in the case of the Union, the exclusive economic zones established by its Member States adjacent to their European territories; (ii) the exclusive economic zone established by the United Kingdom; (b) \"precautionary approach to fisheries management\" means an approach according to which the absence of adequate scientific information does not justify postponing or failing to take management measures to conserve target species, associated or dependent species and non-target species and their environment; (c) \"shared stocks\" means fish, including shellfish, of any kind that are found in the waters of the Parties, which includes molluscs and crustaceans; (d) \"TAC\" means the total allowable catch, which is the maximum quantity of a stock (or stocks) of a particular description that may be caught over a given period; (e) \"non-quota stocks\" means stocks which are not managed through TACs; (f) \"territorial sea\" (of a Party) means, in accordance with the United Nations Convention on the Law of the Sea: (i) in the case of the Union, by way of derogation from Article 774(1), the territorial sea established by its Member States adjacent to their European territories; (ii) the territorial sea established by the United Kingdom; (g) \"waters\" (of a Party) means: (i) in respect of the Union, by way of derogation from Article 774(1), the EEZs of the Member States and their territorial seas; (ii) in respect of the United Kingdom, its EEZ and its territorial sea, excluding for the purposes of Articles 500 and 501 and Annex 38 the territorial sea adjacent to the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man; (h) \"vessel\" (of a Party) means: (i) in the case of the United Kingdom, a fishing vessel flying the flag of the United Kingdom, registered in the United Kingdom, the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, and licensed by a United Kingdom fisheries administration; (ii) in the case of the Union, a fishing vessel flying the flag of a Member State and registered in the Union. CHAPTER 2 CONSERVATION AND SUSTAINABLE EXPLOITATION Article 496 Fisheries management 1. Each Party shall decide on any measures applicable to its waters in pursuit of the objectives set out in Article 494(1) and (2), and having regard to the principles referred to in Article 494(3). 2. A Party shall base the measures referred to in paragraph 1 on the best available scientific advice. A Party shall not apply the measures referred to in paragraph 1 to the vessels of the other Party in its waters unless it also applies the same measures to its own vessels. The second subparagraph is without prejudice to obligations of the Parties under the Port State Measures Agreement, the North East Atlantic Fisheries Commission Scheme of Control and Enforcement, the Northwest Atlantic Fisheries Organisation Conservation and Enforcement Measures, and Recommendation 18-09 by the International Commission for the Conservation of Atlantic Tunas on Port State Measures to Prevent, Deter and Eliminate Illegal, Unreported and Unregulated Fishing. The Specialised Committee on Fisheries may amend the list of pre-existing international obligations referred to in the third subparagraph. 3. Each Party shall notify the other Party of new measures as referred to in paragraph 1 that are likely to affect the vessels of the other Party before those measures are applied, allowing sufficient time for the other Party to provide comments or seek clarification. Article 497 Authorisations, compliance and enforcement 1. Where vessels have access to fish in the waters of the other Party pursuant to Article 500 and Article 502: (a) each Party shall communicate in sufficient time to the other Party a list of vessels for which it seeks to obtain authorisations or licences to fish; and (b) the other Party shall issue authorisations or licences to fish. 2. Each Party shall take all necessary measures to ensure compliance by its vessels with the rules applicable to those vessels in the other Party's waters, including authorisation or licence conditions. CHAPTER 3 ARRANGEMENTS ON ACCESS TO WATERS AND RESOURCES Article 498 Fishing opportunities 1. By 31 January of each year, the Parties shall cooperate to set the schedule for consultations with the aim of agreeing TACs for the stocks listed in Annex 35 for the following year or years. That schedule shall take into account other annual consultations among coastal States that affect either or both of the Parties. 2. The Parties shall hold consultations annually to agree, by 10 December of each year, the TACs for the following year for the stocks listed in Annex 35. This shall include an early exchange of views on priorities as soon as advice on the level of the TACs is received. The Parties shall agree those TACs: (a) on the basis of the best available scientific advice, as well as other relevant factors, including socio-economic aspects; and (b) in compliance with any applicable multi-year strategies for conservation and management agreed by the Parties. 3. The Parties' shares of the TACs for the stocks listed in Annex 35 shall be allocated between the Parties in accordance with the quota shares set out in that Annex. 4. Annual consultations may also cover, inter alia: (a) transfers of parts of one Party's shares of TACs to the other Party; (b) a list of stocks for which fishing is prohibited; (c) the determination of the TAC for any stock which is not listed in Annex 35 or Annex 36 and the Parties' respective shares of those stocks; (d) measures for fisheries management, including, where appropriate, fishing effort limits; (e) stocks of mutual interest to the Parties other than those listed in the Annexes to this Heading. 5. The Parties may hold consultations with the aim of agreeing amended TACs if either Party so requests. 6. A written record documenting the arrangements made between the Parties as a result of consultations under this Article shall be produced and signed by the heads of delegation of the Parties. 7. Each Party shall give sufficient notice to the other Party before setting or amending TACs for the stocks listed in Annex 37. 8. The Parties shall set up a mechanism for voluntary in-year transfers of fishing opportunities between the Parties, to take place each year. The Specialised Committee on Fisheries shall decide on the details of this mechanism. The Parties shall consider making transfers of fishing opportunities for stocks which are, or are projected to be, underfished available at market value through that mechanism. Article 499 Provisional TACs 1. If the Parties have not agreed a TAC for a stock listed in Annex 35 or tables A or B of Annex 36 by 10 December, they shall immediately resume consultations with the continued aim of agreeing the TAC. The Parties shall engage frequently with a view to exploring all possible options for reaching agreement in the shortest possible time. 2. If a stock listed in Annex 35 or in tables A and B of Annex 36 remains without an agreed TAC on 20 December, each Party shall set a provisional TAC corresponding to the level advised by ICES, applying from 1 January. 3. By way of derogation from paragraph 2, the TACs for special stocks shall be set in accordance with guidelines adopted under paragraph 5. 4. For the purposes of this Article, \"special stocks\" means: (a) stocks where the ICES advice is for a zero TAC; (b) stocks caught in a mixed fishery, if that stock or another stock in the same fishery is vulnerable; or (c) other stocks which the Parties consider require special treatment. 5. The Specialised Committee on Fisheries shall adopt guidelines by 1 July 2021 for the setting of provisional TACs for special stocks. 6. Each year when advice is received from ICES on TACs, the Parties shall discuss, as a priority, the special stocks and the application of any guidelines set under paragraph 5 to the setting of provisional TACs by each Party. 7. Each Party shall set its share for each of the provisional TACs, which shall not exceed its share as set out in the corresponding Annex. 8. The provisional TACs and shares referred to in paragraphs 2, 3 and 7 shall apply until agreement is reached under paragraph 1. 9. Each Party shall, immediately, notify the other Party of its provisional TACs under paragraphs 2 and 3 and its provisional share of each of those TACs under paragraph 7. Article 500 Access to waters 1. Provided that TACs have been agreed, each Party shall grant vessels of the other Party access to fish in its waters in the relevant ICES sub-areas that year. Access shall be granted at a level and on conditions determined in those annual consultations. 2. The Parties may agree, in annual consultations, further specific access conditions in relation to: (a) the fishing opportunities agreed; (b) any multi-year strategies for non-quota stocks developed under point (c) of Article 508(1); and (c) any technical and conservation measures agreed by the Parties, without prejudice to Article 496. 3. The Parties shall conduct the annual consultations, including on the level and conditions of access referred to in paragraph 1, in good faith and with the objective of ensuring a mutually satisfactory balance between the interests of both Parties. 4. In particular, the outcome of the annual consultations should normally result in each Party granting: (a) access to fish the stocks listed in Annex 35 and tables A, B and F of Annex 36 in each other's EEZ (or if access is granted under point (c), in EEZs and in the divisions mentioned in that point) at a level that is reasonably commensurate with the Parties' respective shares of the TACs; (b) access to fish non-quota stocks in each other's EEZ (or if access is granted under point (c), in EEZs and in the divisions mentioned in that point), at a level that at least equates to the average tonnage fished by that Party in the waters of the other Party during the period 2012-2016; and (c) access to the waters of the Parties between six and twelve nautical miles from the baselines in ICES divisions 4c and 7d-g for qualifying vessels to the extent that Union fishing vessels and United Kingdom fishing vessels had access to those waters on 31 December 2020. For the purposes of point (c), \"qualifying vessel\" means a vessel of a Party which fished in the zone mentioned in the previous sentence in four of the years between 2012 and 2016, or its direct replacement. Annual consultations referred to in point (c) may include appropriate financial commitments and quota transfers between the Parties. 5. During the application of a provisional TAC, and pending an agreed TAC, the Parties shall grant provisional access to fish in the relevant ICES sub-areas as follows: (a) for stocks listed in Annex 35 and non-quota stocks, from 1 January until 31 March at the levels provided for in points (a) and (b) of paragraph 4; (b) for stocks listed in Annex 36 from 1 January until 14 February at the levels provided for in point (a) of paragraph 4; and (c) in relation to access to fish in the six to twelve nautical miles zone, access in accordance with point (c) of paragraph 4 from 1 January to 31 January at a level equivalent to the average monthly tonnage fished in that zone in the previous three months. Such access, for each of the relevant stocks in points (a) and (b), shall be in proportion to the average percentage of a Party's share of the annual TAC which that Party's vessels fished in the other Party's waters in the relevant ICES sub-areas during the same period of the previous three calendar years. The same shall apply, mutatis mutandis, to access to fish non-quota stocks. By 15 January in relation to the situation in point (c) of this paragraph, by 31 January in respect of the stocks listed in Annex 36, and by 15 March in respect of all other stocks, each Party shall notify the other Party of the change in the level and conditions of access to waters that will apply as of 1 February in relation to the situation in point (c) of this paragraph, as of 15 February in respect of the stocks listed in Annex 36, and as of 1 April in respect of all other stocks for the relevant ICES sub-areas. 6. Without prejudice to Article 499(1) and (8), after the period of one month in relation to the situation in point (c) of paragraph 5 of this Article, one and a half months in respect of the stocks listed in Annex 36 and three months in respect of all other stocks, the Parties shall seek to agree further provisional access arrangements at the appropriate geographical level with the aim of minimising disruption to fishing activities. 7. In granting access under paragraph 1 of this Article, a Party may take into account compliance of individual or groups of vessels with the applicable rules in its waters during the preceding year, and measures taken by the other Party pursuant to Article 497(2) during the preceding year. 8. This Article shall apply subject to Annex 38. Article 501 Compensatory measures in case of withdrawal or reduction of access 1. Following a notification by a Party (\"host Party\") under Article 500(5), the other Party (\"fishing Party\") may take compensatory measures commensurate to the economic and societal impact of the change in the level and conditions of access to waters. Such impact shall be measured on the basis of reliable evidence and not merely on conjecture and remote possibility. Giving priority to those compensatory measures which will least disturb the functioning of this Agreement, the fishing Party may suspend, in whole or in part, access to its waters and the preferential tariff treatment granted to fishery products under Article 21. 2. A compensatory measure referred to in paragraph 1 of this Article may take effect at the earliest seven days after the fishing Party has given notice to the host Party of the intended suspension under paragraph 1 of this Article and, in any case, not earlier than 1 February in relation to the situation in point (c) of Article 500(5), 15 February in respect of Annex 36 and 1 April in respect of other stocks. The Parties shall consult within the Specialised Committee with a view to reaching a mutually agreeable solution. That notification shall identify: (a) the date upon which the fishing Party intends to suspend; and (b) the obligations to be suspended and the level of the intended suspension. 3. After the notification of the compensatory measures in accordance with paragraph 2 of this Article, the host Party may request the establishment of an arbitration tribunal pursuant to Article 739, without having recourse to consultations in accordance with Article 738. The arbitration tribunal may only review the conformity of the compensatory measures with paragraph 1 of this Article. The arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. 4. When the conditions for taking compensatory measures referred to in paragraph 1 are no longer met, such measures shall be withdrawn immediately. 5. Following a finding against the fishing Party in the procedure referred to in paragraph 3 of this Article, the host Party may request the arbitration tribunal, within 30 days from its ruling, to determine a level of suspension of obligations under this Agreement not exceeding the level equivalent to the nullification or impairment caused by the application of the compensatory measures, if it finds that the inconsistency of the compensatory measures with paragraph 1 of this Article is significant. The request shall propose a level of suspension in accordance with the principles set out in paragraph 1 of this Article and any relevant principles set out in Article 761. The host Party may apply the level of suspension of obligations under this Agreement in accordance with the level of suspension determined by the arbitration tribunal, no sooner than 15 days following such ruling. 6. A Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from suspending obligations under this Article. Article 502 Specific access arrangements relating to the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man 1. By way of derogation from Article 500(1) and (3) to (7), Article 501 and Annex 38, each Party shall grant vessels of the other Party access to fish in its waters reflecting the actual extent and nature of fishing activity that it can be demonstrated was carried out during the period beginning on 1 February 2017 and ending on 31 January 2020 by qualifying vessels of the other Party in the waters and under any treaty arrangements that existed on 31 January 2020. 2. For the purposes of this Article and, in so far as the other Articles in this Heading apply in relation to the arrangements for access established under this Article: (a) \"qualifying vessel\" means, in respect of fishing activity carried out in waters adjacent to the Bailiwick of Guernsey, the Bailiwick of Jersey, the Isle of Man or a Member State, any vessel which fished in the territorial sea adjacent to that territory or that Member State on more than 10 days in any of the three 12 month periods ending on 31 January, or between 1 February 2017 and 31 January 2020; (b) \"vessel\" (of a Party)\" means, in respect of the United Kingdom, a fishing vessel flying the flag of the United Kingdom and registered in the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, and licensed by a United Kingdom fisheries administration; (c) \"waters\" (of a Party) means: (i) in respect of the Union, the territorial sea adjacent to a Member State; and (ii) in respect of the United Kingdom, the territorial sea adjacent to each of the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man. 3. At the request of either Party, the Partnership Council shall decide, within 90 days of the entry into force of this Agreement, that this Article, Article 503 and any other provisions of this Heading in so far as they relate to the arrangements provided for in those Articles as well as Article 520(3) to (8) shall cease to apply in respect of one or more of the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man, following 30 days from this decision. 4. The Partnership Council may decide to amend this Article, Article 503 and any other provisions of this Heading in so far as they relate to the arrangements provided for in those Articles. Article 503 Notification periods relating to the importation and direct landing of fishery products 1. The Union shall apply the following notification periods to fishery products caught by vessels flying the flag of the United Kingdom and registered in the Bailiwick of Guernsey or the Bailiwick of Jersey in the territorial sea adjacent to those territories or in the territorial sea adjacent to a Member State: (a) prior notification of between three and five hours before landing fresh fishery products into the Union's territory; (b) prior notification of between one and three hours of the validated catch certificate for the direct movement of consignments of fishery products by sea before the estimated time of arrival at the place of entry into the Union's territory. 2. For the purposes of this Article only, \"fishery products\" means all species of marine fish, molluscs and crustaceans. Article 504 Alignment of management areas 1. By 1 July 2021, the Parties shall request advice from ICES on the alignment of the management areas and the assessment units used by ICES for the stocks marked with an asterisk in Annex 35. 2. Within six months of receipt of the advice referred to in paragraph 1, the Parties shall jointly review that advice and shall jointly consider adjustments to the management areas of the stocks concerned, with a view to agreeing consequential changes to the list of stocks and shares set out in Annex 35. Article 505 Shares of TACs for certain other stocks 1. The Parties' respective shares of the TACs for certain other stocks are set out in Annex 36. 2. Each Party shall notify the relevant States and international organisations of its shares in accordance with the sharing arrangement set out in tables A to D of Annex 36. 3. Any subsequent changes to those shares in tables C and D of Annex 36 are a matter for the relevant multilateral fora. 4. Without prejudice to the powers of the Partnership Council in Article 508(3), any subsequent changes to the shares in tables A and B of Annex 36 after 30 June 2026 are a matter for the relevant multilateral fora. 5. Both Parties shall approach the management of those stocks in tables A to D of Annex 36 in accordance with the objectives and principles set out in Article 494. CHAPTER 4 ARRANGEMENTS ON GOVERNANCE Article 506 Remedial measures and dispute resolution 1. In relation to an alleged failure by a Party (the \"respondent Party\") to comply with this Heading (other than in relation to alleged failures dealt with under paragraph 2), the other Party (the \"complaining Party\") may, after giving notice to the respondent Party: (a) suspend, in whole or in part, access to its waters and the preferential tariff treatment granted to fishery products under Article 21; and (b) if it considers that the suspension referred to in point (a) of this paragraph is not commensurate to the economic and societal impact of the alleged failure, it may suspend, in whole or in part, the preferential tariff treatment of other goods under Article 21; and (c) if it considers that the suspension referred to in points (a) and (b) of this paragraph is not commensurate to the economic and societal impact of the alleged failure, it may suspend, in whole or in part, obligations under Heading One of this Part with the exception of Title XI. If Heading One of this Part is suspended in whole, Heading Three of this part is also suspended. 2. In relation to an alleged failure by a Party (the \"respondent Party\") to comply with Article 502, 503 or any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles, the other Party (the \"complaining Party\"), after giving notice to the respondent Party: (a) may suspend, in whole or in part, access to its waters within the meaning of Article 502; (b) if it considers that the suspension referred to in point (a) of this paragraph is not commensurate to the economic and societal impact of the alleged failure, may suspend, in whole or in part, the preferential tariff treatment granted to fishery products under Article 21; (c) if it considers that the suspension referred to in points (a) and (b) of this paragraph is not commensurate to the economic and societal impact of the alleged failure, may suspend, in whole or in part, the preferential tariff treatment of other goods under Article 21. By way of derogation from paragraph 1 of this Article, remedial measures affecting the arrangements established under Article 502, Article 503 or any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles may not be taken as a result of an alleged failure by a Party to comply with provisions of this Heading unconnected to those arrangements. 3. Measures referred to in paragraphs 1 and 2 shall be proportionate to the alleged failure by the respondent Party and the economic and societal impact thereof. 4. A measure referred to in paragraphs 1 and 2 may take effect at the earliest seven days after the complaining Party has given the respondent Party notice of the proposed suspension. The Parties shall consult within the Specialised Committee on Fisheries with a view to reaching a mutually agreeable solution. That notification shall identify: (a) the way in which the complaining Party considers that the respondent Party has failed to comply; (b) the date upon which the complaining Party intends to suspend; and (c) the level of intended suspension. 5. The complaining Party must, within 14 days of the notification referred to in paragraph 4 of this Article, challenge the alleged failure by the respondent Party to comply with this Heading, as referred to in paragraphs 1 and 2 of this Article, by requesting the establishment of an arbitration tribunal under Article 739. Recourse to arbitration under this Article shall be made without having prior recourse to consultations under Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. 6. The suspension shall cease to apply when: (a) the complaining Party is satisfied that the respondent Party is complying with its relevant obligations under this Heading; or (b) the arbitration tribunal has decided that the respondent Party has not failed to comply with its relevant obligations under this Heading. 7. Following a finding against the complaining Party in the procedure referred to in paragraph 5 of this Article, the respondent Party may request the arbitration tribunal, within 30 days from its ruling, to determine a level of suspension of obligations under this Agreement not exceeding the level equivalent to the nullification or impairment caused by the application of the remedial measures, if it finds that the inconsistency of the remedial measures with paragraph 1 or 2 of this Article is significant. The request shall propose a level of suspension in accordance with paragraph 1 or 2 of this Article and any relevant principles set out in Article 761. The respondent Party may apply the level of suspension of obligations under this Agreement in accordance with the level of suspension determined by the arbitration tribunal, no sooner than 15 days following such ruling. 8. A Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from suspending obligations under this Article. Article 507 Data sharing The Parties shall share such information as is necessary to support the implementation of this Heading, subject to each Party's laws. Article 508 Specialised Committee on Fisheries 1. The Specialised Committee on Fisheries may in particular: (a) provide a forum for discussion and cooperation in relation to sustainable fisheries management; (b) consider the development of multi-year strategies for conservation and management as the basis for the setting of TACs and other management measures; (c) develop multi-year strategies for the conservation and management of non-quota stocks as referred to in point (b) of Article 500(2); (d) consider measures for fisheries management and conservation, including emergency measures and measures to ensure selectivity of fishing; (e) consider approaches to the collection of data for science and fisheries management purposes, the sharing of such data (including information relevant to monitoring, controlling and enforcing compliance), and the consultation of scientific bodies regarding the best available scientific advice; (f) consider measures to ensure compliance with the applicable rules, including joint control, monitoring and surveillance programmes and the exchange of data to facilitate monitoring uptake of fishing opportunities and control and enforcement; (g) develop the guidelines for setting the TACs referred to in Article 499(5); (h) make preparations for annual consultations; (i) consider matters relating to the designation of ports for landings, including the facilitation of the timely notification by the Parties of such designations and of any changes to those designations; (j) establish timelines for the notification of measures referred to in Article 496(3), the communication of the lists of vessels referred to in Article 497(1) and the notice referred to in Article 498(7); (k) provide a forum for consultations under Article 501(2) and Article 506(4); (l) develop guidelines to support the practical application of Article 500; (m) develop a mechanism for voluntary in-year transfers of fishing opportunities between the Parties, as referred to in Article 498(8); and (n) consider the application and implementation of Article 502 and Article 503. 2. The Specialised Committee on Fisheries may adopt measures, including decisions and recommendations: (a) recording matters agreed by the Parties following consultations under Article 498; (b) in relation to any of the matters referred to in points (b), (c), (d), (e), (f), (g), (i), (j), (l), (m) and (n) of paragraph 1 of this Article; (c) amending the list of pre-existing international obligations referred to in Article 496(2); (d) in relation to any other aspect of cooperation on sustainable fisheries management under this Heading; and (e) on the modalities of a review under Article 510. 3. The Partnership Council shall have the power to amend Annexes 35, 36 and 37. Article 509 Termination 1. Without prejudice to Article 779 or Article 521, each Party may at any moment terminate this Heading, by written notification through diplomatic channels. In that event, Heading One, Heading Two, Heading Three and this Heading shall cease to be in force on the first day of the ninth month following the date of notification. 2. In the event of termination of this Heading pursuant to paragraph 1 of this Article, Article 779 or Article 521, obligations entered into by the Parties under this Heading for the year ongoing at the time when this Heading ceases to be in force shall continue to apply until the end of the year. 3. Notwithstanding paragraph 1 of this Article, Heading Two may remain in force, if the Parties agree to integrate the relevant parts of Title XI of Heading One. 4. By way of derogation from paragraphs 1 to 3 of this Article and without prejudice to Article 779 or Article 521: (a) unless agreed otherwise between the Parties, Article 502, Article 503 and any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles, shall remain in force until: (i) they are terminated by either Party giving to the other Party three years' written notice of termination; or (ii) if earlier, the date on which Article 520(3) to (5) cease to be in force; (b) for the purposes of point (a)(i), notice of termination may be given in respect of one or more of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man and Article 502, Article 503 and any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles, shall continue to be in force for those territories in respect of which a notice of termination has not been given; and (c) for the purposes of point (a)(ii), if Article 520(3) to (5) cease to be in force in relation to one or more (but not all) of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, Article 502, Article 503 and any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles, shall continue to be in force for those territories in respect of which Article 520(3) to (5) remain in force. Article 510 Review clause 1. The Parties, within the Partnership Council, shall jointly review the implementation of this Heading four years after the end of the adjustment period referred to in the Article 1 of Annex 38 with the aim of considering whether arrangements, including in relation to access to waters, can be further codified and strengthened. 2. Such a review may be repeated at subsequent intervals of four years after the conclusion of the first review. 3. The Parties shall decide, in advance, on the modalities of the review through the Specialised Committee on Fisheries. 4. The review shall, in particular, allow for an evaluation, in relation to the previous years, of: (a) the provisions for access to each other's waters under Article 500; (b) the shares of TACs set out in Annexes 35, 36 and 37; (c) the number and extent of transfers as part of annual consultations under Article 498(4) and any transfers under Article 498(8); (d) the fluctuations in annual TACs; (e) compliance by both Parties with the provisions of this Heading and the compliance by vessels of each Party with the rules applicable to those vessels when in the other Party's waters; (f) the nature and extent of cooperation under this Heading; and (g) any other element the Parties decide, in advance, through the Specialised Committee on Fisheries. Article 511 Relationship with other agreements 1. Subject to paragraph 2, this Heading shall be without prejudice to other existing agreements concerning fishing by vessels of a Party within the area of jurisdiction of the other Party. 2. This Heading shall supersede and replace any existing agreements or arrangements with respect to fishing by Union fishing vessels in the territorial sea adjacent to the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man and with respect to fishing by United Kingdom fishing vessels registered in the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man in the territorial sea adjacent to a Member State. However, if the Partnership Council takes a decision in accordance with Article 502 for this Agreement to cease to apply in respect of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, the relevant agreements or arrangements shall not be superseded and replaced in respect of the territory or territories for which such a decision has been taken. HEADING SIX OTHER PROVISIONS Article 512 Definitions Unless otherwise specified, for the purposes of Part Two, the Protocol on mutual administrative assistance in customs matters and the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties, the following definitions apply: (a) \"customs authority\" means: (i) with respect to the Union, the services of the European Commission responsible for customs matters or, as appropriate, the customs administrations and any other authorities empowered in the Member States of the Union to apply and enforce customs legislation, and (ii) with respect to the United Kingdom, Her Majesty's Revenue and Customs and any other authority responsible for customs matters; (b) \"customs duty\" means any duty or charge of any kind imposed on, or in connection with, the importation of a good but does not include: (i) a charge equivalent to an internal tax imposed consistently with Article 19; (ii) an anti-dumping, special safeguard, countervailing or safeguard duty applied consistently with GATT 1994, the Anti-dumping Agreement, the Agreement on Agriculture, the Agreement on Subsidies and Countervailing Measures or the Agreement on Safeguards, as appropriate; or (iii) a fee or other charge imposed on or in connection with importation that is limited in amount to the approximate cost of the services rendered; (c) \"CPC\" means the Provisional Central Product Classification (Statistical Papers Series M No.77, Department of International Economic and Social Affairs, Statistical Office of the United Nations, New York, 1991); (d) \"existing\" means in effect on the date of entry into force of this Agreement; (e) \"goods of a Party\" means domestic products within the meaning of GATT 1994, and includes originating goods of that Party; (f) \"Harmonised System\" or \"HS\" means the Harmonised Commodity Description and Coding System, including all legal notes and amendments thereto developed by the World Customs Organization; (g) \"heading\" means the first four digits in the tariff classification number under the Harmonised System; (h) \"legal person\" means any legal entity duly constituted or otherwise organised under applicable law, whether for profit or otherwise, and whether privately-owned or governmentally-owned, including any corporation, trust, partnership, joint venture, sole proprietorship or association; (i) \"measure\" means any measure by a Party, whether in the form of a law, regulation, rule, procedure, decision, administrative action, requirement or practice, or any other form; (71) (j) \"measures of a Party\" means any measures adopted or maintained by: (i) central, regional or local governments or authorities; and (ii) non-governmental bodies in the exercise of powers delegated by central, regional or local governments or authorities; \"measures of a Party\" includes measures adopted or maintained by entities listed under sub-paragraphs (i) and (ii) by instructing, directing or controlling, either directly or indirectly, the conduct of other entities with regard to those measures. (k) \"natural person of a Party\" means (72): (i) for the European Union, a national of a Member State according to its law; (73) and (ii) for the United Kingdom, a British citizen; (l) \"person\" means a natural person or a legal person; (m) \"sanitary or phytosanitary measure\" means any measure referred to in paragraph 1 of Annex A to the SPS Agreement; (n) \"third country\" means a country or territory outside the territorial scope of application of this Agreement; and (o) \"WTO\" means the World Trade Organization. Article 513 WTO Agreements For the purposes of this Agreement, the WTO Agreements are referred to as follows: (a) \"Agreement on Agriculture\" means the Agreement on Agriculture, contained in Annex 1A to the WTO Agreement; (b) \"Anti-dumping Agreement\" means the Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 1994; (c) \"GATS\" means the General Agreement on Trade in Services, contained in Annex 1B to the WTO Agreement; (d) \"GATT 1994\" means the General Agreement on Tariffs and Trade 1994, contained in Annex 1A to the WTO Agreement; (e) \"GPA\" means the Agreement on Government Procurement in Annex 4 to the WTO Agreement (74); (f) \"Safeguards Agreement\" means the Agreement on Safeguards, contained in Annex 1A to the WTO Agreement; (g) \"SCM Agreement\" means the Agreement on Subsidies and Countervailing Measures, contained in Annex 1A to the WTO Agreement; (h) \"SPS Agreement\" means the Agreement on the Application of Sanitary and Phytosanitary Measures, contained in Annex 1A to the WTO Agreement; (i) \"TBT Agreement\" means the Agreement on Technical Barriers to Trade, contained in Annex 1 to the WTO Agreement; (j) \"TRIPS Agreement\" means the Agreement on Trade-Related Aspects of Intellectual Property Rights, contained in Annex 1C to the WTO Agreement; and (k) \"WTO Agreement\" means the Marrakesh Agreement Establishing the World Trade Organization, done at Marrakesh on 15 April 1994. Article 514 Establishment of a free trade area The Parties hereby establish a free trade area, in conformity with Article XXIV of GATT 1994 and Article V of GATS. Article 515 Relation to the WTO Agreement The Parties affirm their rights and obligations with respect to each other under the WTO Agreement and other agreements to which they are party. Nothing in this Agreement shall be construed as requiring either Party to act in a manner inconsistent with its obligations under the WTO Agreement. Article 516 WTO case-law The interpretation and application of the provisions of this Part shall take into account relevant interpretations in reports of WTO panels and of the Appellate Body adopted by the Dispute Settlement Body of the WTO as well as in arbitration awards under the Dispute Settlement Understanding. Article 517 Fulfilment of obligations Each Party shall adopt any general or specific measures required to fulfil their obligations under this Part, including those required to ensure its observance by central, regional or local governments and authorities, as well as non-governmental bodies in the exercise of powers delegated to them. Article 518 References to laws and other Agreements 1. Unless otherwise specified, where reference is made in this Part to laws and regulations of a Party, those laws and regulations shall be understood to include amendments thereto. 2. Unless otherwise specified, where international agreements are referred to or incorporated into this Part, in whole or in part, they shall be understood to include amendments thereto or their successor agreements entering into force for both Parties on or after the date of signature of this Agreement. If any matter arises regarding the implementation or application of the provisions of this Part as a result of such amendments or successor agreements, the Parties may, on request of either Party, consult with each other with a view to finding a mutually satisfactory solution to this matter, as necessary. Article 519 Tasks of the Partnership Council in Part Two The Partnership Council may: (a) adopt decisions to amend: (i) Chapter 2 of Title I of Heading one of Part two and its Annexes, in accordance with Article 68; (ii) the arrangements set out in Annexes 16 and 17, in accordance with Article 96(8); (iii) Appendices 15-A and 15-B, in accordance with Article 2(3) of Annex 15; (iv) Appendix 15-C, in accordance with Article 3(3) of Annex 15; (v) Appendices 14-A, 14-B, 14-C and 14-D, in accordance with Article 1 of Annex 14; (vi) Appendices 12-A, 12-B and 12-C, in accordance with Article 11 of Annex 12; (vii) the Annex on Authorised Economic Operators, the Protocol on mutual administrative assistance in customs matters, the Protocol on combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties, and the list of goods set out in Article 117(2), in accordance with Article 122; (viii) the relevant Sub-section under Section B of Annex 25, in accordance with Article 293; (ix) Annexes 26, 27 and 28, in accordance with Article 329; (x) Article 364(4) in accordance with that paragraph, the third sentence of Article 365(2) in accordance with the fourth sentence of that paragraph, Article 365(3) in accordance with that paragraph, Article 367 in accordance with paragraph 1 of that Article and Article 373 in accordance with paragraph 7 of that Article; (xi) Article 502, Article 503 and any other provision of Heading Five, in accordance with Article 502(4); (xii) Annexes 35, 36 and 37, in accordance with Article 508(3); (xiii) any other provision, protocol, appendix or annex, for which the possibility of such decision is explicitly foreseen in this Part; (b) adopt decisions to issue interpretations of the provisions of this Part. Article 520 Geographical application 1. The provisions of this Agreement concerning the tariff treatment of goods, including rules of origin and the temporary suspension of this treatment shall also apply, with respect to the Union, to those areas of the customs territory of the Union, as defined by Article 4 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (75), which are not covered by point (a) of Article 774(1). 2. Without prejudice to Article 774(2), (3) and (4), the rights and obligations of the Parties under this Part shall also apply with regard to the areas beyond each Party's territorial sea, including the sea-bed and subsoil thereof, over which that Party exercises sovereign rights or jurisdiction in accordance with international law including the United Nations Convention on the Law of the Sea and its laws and regulations which are consistent with international law (76). 3. Subject to the exceptions contained in paragraph 4 of this Article, Chapters 1, 2 and 5 of Title I of Heading One and the Protocols and Annexes to those Chapters shall also apply, with respect to the United Kingdom, to the territories referred to in Article 774(2). For that purpose, the territories referred to in Article 774(2) shall be considered as being part of the customs territory of the United Kingdom. The customs authorities of the territories referred to in Article 774(2) shall be responsible for the application and implementation of these Chapters, and the Protocols and Annexes to these Chapters, in their respective territories. References to \"customs authority\" in those provisions shall be read accordingly. However, requests and communications made under these Chapters, and the Protocols and Annexes to these Chapters, shall be administered by the customs authority of the United Kingdom. 4. Article 110, Annex 18 and the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties shall not apply to the Bailiwick of Jersey or the Bailiwick of Guernsey. 5. Chapters 3 and 4 of Title I of Heading One and the Annexes to those Chapters shall also apply, with respect to the United Kingdom, to the territories referred to in Article 774(2). The authorities of the territories referred to in Article 774(2) shall be responsible for the application and implementation of these Chapters, and the Annexes to these Chapters, in their respective territories and relevant references shall be read accordingly. However, requests and communications made under these Chapters, and the Annexes to these Chapters, shall be administered by the authorities of the United Kingdom. 6. Without prejudice to Article 779 and Article 521 and unless agreed otherwise between the Parties, paragraphs 3 to 5 of this Article shall remain in force until the earlier of: (a) expiry of a period of three years following written notice of termination to the other Party; or (b) the date on which Article 502, Article 503 and any other provision of Heading Five in so far as it relates to the arrangements provided for in those Articles cease to be in force. 7. For the purposes of point (a) of paragraph 6, notice of termination may be given in respect of one or more of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man and paragraphs 3 to 5 of this Article shall continue in force for those territories in respect of which a notice of termination has not been given. 8. For the purposes of point (b) of paragraph 6, if Article 502, Article 503 and any other provision of Heading Five in so far as it relates to the arrangements provided for in those Articles cease to be in force in relation to one or more (but not all) of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, paragraphs 3 to 5 of this Article shall continue to be in force for those territories in respect of which Article 502, Article 503 and any other provision of Heading Five in so far as it relates to the arrangements provided for in those Articles remain in force. Article 521 Termination of Part Two Without prejudice to Article 779, each Party may at any moment terminate this Part by written notification through diplomatic channels. In that event, this Part shall cease to be in force on the first day of the ninth month following the date of notification. Heading Four and the Protocol on Social Security Coordination shall not be terminated pursuant to this Article. PART THREE LAW ENFORCEMENT AND JUDICIAL COOPERATION IN CRIMINAL MATTERS TITLE I GENERAL PROVISIONS Article 522 Objective 1. The objective of this Part is to provide for law enforcement and judicial cooperation between the Member States and Union institutions, bodies, offices and agencies, on the one side, and the United Kingdom, on the other side, in relation to the prevention, investigation, detection and prosecution of criminal offences and the prevention of and fight against money laundering and financing of terrorism. 2. This Part only applies to law enforcement and judicial cooperation in criminal matters taking place exclusively between the United Kingdom, on the one side, and the Union and the Member States, on the other side. It does not apply to situations arising between the Member States, or between Member States and Union institutions, bodies, offices and agencies, nor does it apply to the activities of authorities with responsibilities for safeguarding national security when acting in that field. Article 523 Definitions For the purposes of this Part, the following definitions apply: (a) \"third country\" means a country other than a Member State or the United Kingdom; (b) \"special categories of personal data\" means personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, biometric data processed for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation; (c) \"genetic data\" means all personal data relating to the genetic characteristics of an individual that have been inherited or acquired, which give unique information about the physiology or the health of that individual, resulting in particular from an analysis of a biological sample from the individual in question; (d) \"biometric data\" means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data; (e) \"processing\" means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction; (f) \"personal data breach\" means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed; (g) \"filing system\" means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis; (h) \"Specialised Committee on Law Enforcement and Judicial Cooperation\" means the Committee by that name established by Article 8. Article 524 Protection of human rights and fundamental freedoms 1. The cooperation provided for in this Part is based on the Parties' and Member States' long-standing respect for democracy, the rule of law and the protection of fundamental rights and freedoms of individuals, including as set out in the Universal Declaration of Human Rights and in the European Convention on Human Rights, and on the importance of giving effect to the rights and freedoms in that Convention domestically. 2. Nothing in this Part modifies the obligation to respect fundamental rights and legal principles as reflected, in particular, in the European Convention on Human Rights and, in the case of the Union and its Member States, in the Charter of Fundamental Rights of the European Union. Article 525 Protection of personal data 1. The cooperation provided for in this Part is based on the Parties' long-standing commitment to ensuring a high level of protection of personal data. 2. To reflect that high level of protection, the Parties shall ensure that personal data processed under this Part is subject to effective safeguards in the Parties' respective data protection regimes, including that: (a) personal data is processed lawfully and fairly, in compliance with the principles of data minimisation, purpose limitation, accuracy and storage limitation; (b) processing of special categories of personal data is only permitted to the extent necessary and subject to appropriate safeguards adapted to the specific risks of the processing; (c) a level of security appropriate to the risk of the processing is ensured through relevant technical and organisational measures, in particular as regards the processing of special categories of personal data; (d) data subjects are granted enforceable rights of access, rectification and erasure, subject to possible restrictions provided for by law which constitute necessary and proportionate measures in a democratic society to protect important objectives of public interest; (e) in the event of a data breach creating a risk to the rights and freedoms of natural persons, the competent supervisory authority is notified without undue delay of the breach; where the breach is likely to result in a high risk to the rights and freedoms of natural persons, the data subjects are also notified, subject to possible restrictions provided for by law which constitute necessary and proportionate measures in a democratic society to protect important objectives of public interest; (f) onward transfers to a third country are allowed only subject to conditions and safeguards appropriate to the transfer ensuring that the level of protection is not undermined; (g) the supervision of compliance with data protection safeguards and the enforcement of data protection safeguards are ensured by independent authorities; and (h) data subjects are granted enforceable rights to effective administrative and judicial redress in the event that data protection safeguards have been violated. 3. The United Kingdom, on the one side, and the Union, also on behalf of any of its Member States, on the other side, shall notify the Specialised Committee on Law Enforcement and Judicial Cooperation of the supervisory authorities responsible for overseeing the implementation of, and ensuring compliance with, data protection rules applicable to cooperation under this Part. The supervisory authorities shall cooperate to ensure compliance with this Part. 4. The provisions on the protection of personal data set out in this Part apply to the processing of personal data wholly or partly by automated means, and to the processing other than by automated means of personal data which form part of a filing system or are intended to form part of a filing system. 5. This Article is without prejudice to the application of any specific provisions in this Part relating to the processing of personal data. Article 526 Scope of cooperation where a Member State no longer participates in analogous measures under Union law 1. This Article applies if a Member State ceases to participate in, or enjoy rights under, provisions of Union law relating to law enforcement and judicial cooperation in criminal matters analogous to any of the relevant provisions of this Part. 2. The United Kingdom may notify the Union in writing of its intention to cease to operate the relevant provisions of this Part in relation to that Member State. 3. A notification given under paragraph 2 takes effect on the date specified therein, which shall be no earlier than the date on which the Member State ceases to participate in, or to enjoy rights under, the provisions of Union law referred to in paragraph 1. 4. If the United Kingdom gives notification under this Article of its intention to cease to apply the relevant provisions of this Part, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what measures are needed to ensure that any cooperation initiated under this Part that is affected by the cessation is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under the relevant provisions of this Part before they cease to be applied, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the cessation takes effect. 5. The Union shall notify the United Kingdom in writing, through diplomatic channels, of the date on which the Member State is to resume its participation in, or the enjoyment of rights under, the provisions of Union law in question. The application of the relevant provisions of this Part shall be reinstated on that date or, if later, on the first day of the month following the day on which that notification has been given. 6. To facilitate the application of this Article, the Union shall inform the United Kingdom when a Member State ceases to participate in, or enjoy rights under, provisions of Union law relating to law enforcement and judicial cooperation in criminal matters analogous to the relevant provisions of this Part. TITLE II EXCHANGES OF DNA, FINGERPRINTS AND VEHICLE REGISTRATION DATA Article 527 Objective The objective of this Title is to establish reciprocal cooperation between the competent law enforcement authorities of the United Kingdom, on the one side, and the Member States, on the other side, on the automated transfer of DNA profiles, dactyloscopic data and certain domestic vehicle registration data. Article 528 Definitions For the purposes of this Title, the following definitions apply: (a) \"competent law enforcement authority\" means a domestic police, customs or other authority that is authorised by domestic law to detect, prevent and investigate offences or criminal activities and to exercise authority and take coercive measures in the context of such activities; agencies, bodies or other units dealing especially with national security issues are not competent law enforcement authorities for the purposes of this Title; (b) \"search\" and \"comparison\", as referred to in Articles 530, 531, 534 and 539 mean the procedures by which it is established whether there is a match between, respectively, DNA data or dactyloscopic data which have been communicated by one State and DNA data or dactyloscopic data stored in the databases of one, several, or all of the other States; (c) \"automated searching\", as referred to in Article 537, means an online access procedure for consulting the databases of one, several, or all of the other States; (d) \"non-coding part of DNA\" means chromosome regions not genetically expressed, i.e. not known to provide for any functional properties of an organism; (e) \"DNA profile\" means a letter or numeric code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci); (f) \"DNA reference data\" means DNA profile and reference number; DNA reference data shall only include DNA profiles established from the non-coding part of DNA and a reference number; DNA reference data shall not contain any data from which the data subject can be directly identified; DNA reference data which is not attributed to any natural person (unidentified DNA profiles) shall be recognisable as such; (g) \"reference DNA profile\" means the DNA profile of an identified person; (h) \"unidentified DNA profile\" means the DNA profile obtained from traces collected during the investigation of criminal offences and belonging to a person not yet identified; (i) \"note\" means a State's marking on a DNA profile in its domestic database indicating that there has already been a match for that DNA profile on another State's search or comparison; (j) \"dactyloscopic data\" means fingerprint images, images of fingerprint latents, palm prints, palm print latents and templates of such images (coded minutiae), when they are stored and dealt with in an automated database; (k) \"dactyloscopic reference data\" means dactyloscopic data and reference number; dactyloscopic reference data shall not contain any data from which the data subject can be directly identified; dactyloscopic reference data which is not attributed to any natural person (unidentified dactyloscopic data) shall be recognisable as such; (l) \"vehicle registration data\" means the data-set as specified in Chapter 3 of Annex 39; (m) \"individual case\", as referred to in Article 530(1), second sentence, Article 534(1), second sentence and Article 537(1), means a single investigation or prosecution file; if such a file contains more than one DNA profile, or one piece of dactyloscopic data or vehicle registration data, they may be transmitted together as one request; (n) \"laboratory activity\" means any measure taken in a laboratory when locating and recovering traces on items, as well as developing, analysing and interpreting forensic evidence regarding DNA profiles and dactyloscopic data, with a view to providing expert opinions or exchanging forensic evidence; (o) \"results of laboratory activities\" means any analytical outputs and directly associated interpretation; (p) \"forensic service provider\" means any organisation, public or private, that carries out laboratory activities at the request of competent law enforcement or judicial authorities; (q) \"domestic accreditation body\" means the sole body in a State that performs accreditation with authority derived from the State. Article 529 Establishment of domestic DNA analysis files 1. The States shall open and keep domestic DNA analysis files for the investigation of criminal offences. 2. For the purpose of implementing this Title, the States shall ensure the availability of DNA reference data from their domestic DNA analysis files as referred to in paragraph 1. 3. The States shall declare the domestic DNA analysis files to which Articles 529 to 532 and Articles 535, 536 and 539 apply and the conditions for automated searching as referred to in Article 530(1). Article 530 Automated searching of DNA profiles 1. For the investigation of criminal offences, States shall allow other States' national contact points as referred to in Article 535 access to the DNA reference data in their DNA analysis files, with the power to conduct automated searches by comparing DNA profiles. Searches may be conducted only in individual cases and in compliance with the requesting State's domestic law. 2. If an automated search shows that a DNA profile supplied matches DNA profiles entered in the requested State's searched file, the requested State shall send to the national contact point of the requesting State in an automated way the DNA reference data with which a match has been found. If no match can be found, this shall be notified automatically. Article 531 Automated comparison of DNA profiles 1. For the investigation of criminal offences, the States, via their national contact points, shall compare the DNA profiles of their unidentified DNA profiles with all DNA profiles from other domestic DNA analysis files' reference data in accordance with mutually accepted practical arrangements between the States concerned. DNA profiles shall be supplied and compared in automated form. Unidentified DNA profiles shall be supplied for comparison only where provided for under the requesting State's domestic law. 2. If a State, as a result of the comparison referred to in paragraph 1, finds that any DNA profiles supplied by another State match any of those in its DNA analysis files, it shall supply that other State's national contact point with the DNA reference data with which a match has been found without delay. Article 532 Collection of cellular material and supply of DNA profiles Where, in ongoing investigations or criminal proceedings, there is no DNA profile available for a particular individual present within a requested State's territory, the requested State shall provide legal assistance by collecting and examining cellular material from that individual and by supplying the DNA profile obtained to the requesting State, if: (a) the requesting State specifies the purpose for which it is required; (b) the requesting State produces an investigation warrant or statement issued by the competent authority, as required under that State's domestic law, showing that the requirements for collecting and examining cellular material would be fulfilled if the individual concerned were present within the requesting State's territory; and (c) under the requested State's law, the requirements for collecting and examining cellular material and for supplying the DNA profile obtained are fulfilled. Article 533 Dactyloscopic data For the purpose of implementing this Title, the States shall ensure the availability of dactyloscopic reference data from the file for the domestic automated fingerprint identification systems established for the prevention and investigation of criminal offences. Article 534 Automated searching of dactyloscopic data 1. For the prevention and investigation of criminal offences, States shall allow other States' national contact points, as referred to in Article 535, access to the reference data in the automated fingerprint identification systems which they have established for that purpose, with the power to conduct automated searches by comparing dactyloscopic data. Searches may be conducted only in individual cases and in compliance with the requesting State's domestic law. 2. The confirmation of a match of dactyloscopic data with reference data held by the requested State shall be carried out by the national contact point of the requesting State by means of the automated supply of the reference data required for a clear match. Article 535 National contact points 1. For the purposes of the supply of data as referred to in Articles 530, 531 and 534, the States shall designate national contact points. 2. In respect of the Member States, national contact points designated for an analogous exchange of data within the Union shall be considered as national contact points for the purpose of this Title. 3. The powers of the national contact points shall be governed by the applicable domestic law. Article 536 Supply of further personal data and other information If the procedure referred to in Articles 530, 531 and 534 show a match between DNA profiles or dactyloscopic data, the supply of further available personal data and other information relating to the reference data shall be governed by the domestic law, including the legal assistance rules, of the requested State, without prejudice to Article 539(1). Article 537 Automated searching of vehicle registration data 1. For the prevention and investigation of criminal offences and in dealing with other offences within the jurisdiction of the courts or a public prosecutor in the requesting State, as well as in maintaining public security, States shall allow other States' national contact points, as referred to in paragraph 2, access to the following domestic vehicle registration data, with the power to conduct automated searches in individual cases: (a) data relating to owners or operators; and (b) data relating to vehicles. 2. Searches may be conducted under paragraph 1 only with a full chassis number or a full registration number and in compliance with the requesting State's domestic law. 3. For the purposes of the supply of data as referred to in paragraph 1, the States shall designate a national contact point for incoming requests from other States. The powers of the national contact points shall be governed by the applicable domestic law. Article 538 Accreditation of forensic service providers carrying out laboratory activities 1. The States shall ensure that their forensic service providers carrying out laboratory activities are accredited by a domestic accreditation body as complying with EN ISO/IEC 17025. 2. Each State shall ensure that the results of accredited forensic service providers carrying out laboratory activities in other States are recognised by its authorities responsible for the prevention, detection, and investigation of criminal offences as being equally reliable as the results of domestic forensic service providers carrying out laboratory activities accredited to EN ISO/IEC 17025. 3. The competent law enforcement authorities of the United Kingdom shall not carry out searches and automated comparison in accordance with Articles 530, 531 and 534 before the United Kingdom has implemented and applied the measures referred to in paragraph 1 of this Article. 4. Paragraphs 1 and 2 do not affect domestic rules on the judicial assessment of evidence. 5. The United Kingdom shall communicate to the Specialised Committee on Law Enforcement and Judicial Cooperation the text of the main provisions adopted to implement and apply the provisions of this Article. Article 539 Implementing measures 1. For the purposes of this Title, States shall make all categories of data available for searching and comparison to the competent law enforcement authorities of other States under conditions equal to those under which they are available for searching and comparison by domestic competent law enforcement authorities. States shall supply further available personal data and other information relating to the reference data as referred to in Article 536 to the competent law enforcement authorities of other States for the purposes of this Title under conditions equal to those under which they would be supplied to domestic authorities. 2. For the purpose of implementing the procedures referred to in Articles 530, 531, 534 and 537, technical and procedural specifications are laid down in Annex 39. 3. The declarations made by Member States in accordance with Council Decisions 2008/615/JHA (77) and 2008/616/JHA (78) shall also apply in their relations with the United Kingdom. Article 540 Ex ante evaluation 1. In order to verify whether the United Kingdom has fulfilled the conditions set out in Article 539 and Annex 39, an evaluation visit and a pilot run, to the extent required by Annex 39, shall be carried out in respect of, and under conditions and arrangements acceptable to, the United Kingdom. In any event, a pilot run shall be carried out in relation to the searching of data under Article 537. 2. On the basis of an overall evaluation report on the evaluation visit and, where applicable, the pilot run, as referred to in paragraph 1, the Union shall determine the date or dates from which personal data may be supplied by Member States to the United Kingdom pursuant to this Title. 3. Pending the outcome of the evaluation referred to in paragraph 1, from the date of the entry into force of this Agreement, Member States may supply to the United Kingdom personal data as referred to in Articles 530, 531, 534 and 536 until the date or dates determined by the Union in accordance with paragraph 2 of this Article, but not longer than nine months after the entry into force of this Agreement. The Specialised Committee on Law Enforcement and Judicial Cooperation may extend this period once by a maximum of nine months. Article 541 Suspension and disapplication 1. In the event that the Union considers it necessary to amend this Title because Union law relating to the subject matter governed by this Title is amended substantially, or is in the process of being amended substantially, it may notify the United Kingdom accordingly with a view to agreeing on a formal amendment of this Agreement in relation to this Title. Following such notification, the Parties shall engage in consultations. 2. Where within nine months of that notification the Parties have not reached an agreement amending this Title, the Union may decide to suspend the application of this Title or any provisions of this Title for a period of up to nine months. Before the end of that period, the Parties may agree on an extension of the suspension for an additional period of up to nine months. If by the end of the suspension period the Parties have not reached an agreement amending this Title, the suspended provisions shall cease to apply on the first day of the month following the expiry of the suspension period, unless the Union informs the United Kingdom that it no longer seeks any amendment to this Title. In that case, the suspended provisions of this Title shall be reinstated. 3. If any of the provisions of this Title are suspended under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what steps are needed to ensure that any cooperation initiated under this Title and affected by the suspension is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Title before the provisions concerned by the suspension provisionally cease to apply, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the suspension takes effect. TITLE III TRANSFER AND PROCESSING OF PASSENGER NAME RECORD DATA Article 542 Scope 1. This Title lays down rules under which passenger name record data may be transferred to, processed and used by the United Kingdom competent authority for flights between the Union and the United Kingdom, and establishes specific safeguards in that regard. 2. This Title applies to air carriers operating passenger flights between the Union and the United Kingdom. 3. This Title also applies to air carriers incorporated, or storing data, in the Union and operating passenger flights to or from the United Kingdom. 4. This Title also provides for police and judicial cooperation in criminal matters between the United Kingdom and the Union in respect of PNR data. Article 543 Definitions For the purposes of this Title, the following definitions apply: (a) \"air carrier\" means an air transport undertaking with a valid operating licence or equivalent permitting it to carry out carriage of passengers by air between the United Kingdom and the Union; (b) \"passenger name record\" (\"PNR\") means a record of each passenger's travel requirements which contains information necessary to enable reservations to be processed and controlled by the booking and participating air carriers for each journey booked by or on behalf of any person, whether it is contained in reservation systems, departure control systems used to check passengers into flights, or equivalent systems providing the same functionalities; specifically, as used in this Title, PNR data consists of the elements set out in Annex 40; (c) \"United Kingdom competent authority\" means the United Kingdom authority responsible for receiving and processing PNR data under this Agreement; if the United Kingdom has more than one competent authority it shall provide a passenger data single window facility that allows air carriers to transfer PNR data to a single data transmission entry point and shall designate a single point of contact for the purpose of receiving and making requests under Article 546; (d) \"Passenger Information Units\" (\"PIUs\") means the Units established or designated by Member States that are responsible for receiving and processing PNR data; (e) \"terrorism\" means any offence listed in Annex 45; (f) \"serious crime\" means any offence punishable by a custodial sentence or detention order for a maximum period of at least three years under the domestic law of the United Kingdom. Article 544 Purposes of the use of PNR data 1. The United Kingdom shall ensure that PNR data received pursuant to this Title is processed strictly for the purposes of preventing, detecting, investigating or prosecuting terrorism or serious crime and for the purposes of overseeing the processing of PNR data within the terms set out in this Agreement. 2. In exceptional cases, the United Kingdom competent authority may process PNR data where necessary to protect the vital interests of any natural person, such as: (a) a risk of death or serious injury; or (b) a significant public health risk, in particular as identified under internationally recognised standards. 3. The United Kingdom competent authority may also process PNR data on a case-by-case basis where the disclosure of relevant PNR data is compelled by a United Kingdom court or administrative tribunal in a proceeding directly related to any of the purposes referred to in paragraph 1. Article 545 Ensuring PNR data is provided 1. The Union shall ensure that air carriers are not prevented from transferring PNR data to the United Kingdom competent authority pursuant to this Title. 2. The Union shall ensure that air carriers may transfer PNR data to the United Kingdom competent authority through authorised agents, who act on behalf of and under the responsibility of an air carrier, pursuant to this Title. 3. The United Kingdom shall not require an air carrier to provide elements of PNR data which are not already collected or held by the air carrier for reservation purposes. 4. The United Kingdom shall delete any data transferred to it by an air carrier pursuant to this Title upon receipt of that data, if that data element is not listed in Annex 40. Article 546 Police and judicial cooperation 1. The United Kingdom competent authority shall share with Europol or Eurojust, within the scope of their respective mandates, or with the PIUs of the Member States all relevant and appropriate analytical information containing PNR data as soon as possible in specific cases where necessary to prevent, detect, investigate, or prosecute terrorism or serious crime. 2. At the request of Europol or Eurojust, within the scope of their respective mandates, or of the PIU of a Member State, the United Kingdom competent authority shall share PNR data, the results of processing those data, or analytical information containing PNR data, in specific cases where necessary to prevent, detect, investigate, or prosecute terrorism or serious crime. 3. The PIUs of the Member States shall share with the United Kingdom competent authority all relevant and appropriate analytical information containing PNR data as soon as possible in specific cases where necessary to prevent, detect, investigate, or prosecute terrorism or serious crime. 4. At the request of the United Kingdom competent authority, the PIUs of the Member States shall share PNR data, the results of processing those data, or analytical information containing PNR data, in specific cases where necessary to prevent, detect, investigate, or prosecute terrorism or serious crime. 5. The Parties shall ensure that the information referred to in paragraphs 1 to 4 is shared in accordance with agreements and arrangements on law enforcement or information sharing between the United Kingdom and Europol, Eurojust, or the relevant Member State. In particular, the exchange of information with Europol under this Article shall take place through the secure communication line established for the exchange of information through Europol. 6. The United Kingdom competent authority and the PIUs of the Member States shall ensure that only the minimum amount of PNR data necessary is shared under paragraphs 1 to 4. Article 547 Non-discrimination The United Kingdom shall ensure that the safeguards applicable to the processing of PNR data apply to all natural persons on an equal basis without unlawful discrimination. Article 548 Use of special categories of personal data Any processing of special categories of personal data shall be prohibited under this Title. To the extent that any PNR data which is transferred to the United Kingdom competent authority includes special categories of personal data, the United Kingdom competent authority shall delete such data. Article 549 Data security and integrity 1. The United Kingdom shall implement regulatory, procedural or technical measures to protect PNR data against accidental, unlawful or unauthorised access, processing or loss. 2. The United Kingdom shall ensure compliance verification and the protection, security, confidentiality, and integrity of the data. In that regard, the United Kingdom shall: (a) apply encryption, authorisation, and documentation procedures to the PNR data; (b) limit access to PNR data to authorised officials; (c) hold PNR data in a secure physical environment that is protected with access controls; and (d) establish a mechanism that ensures that PNR data queries are conducted in a manner consistent with Article 544. 3. If a natural person's PNR data is accessed or disclosed without authorisation, the United Kingdom shall take measures to notify that natural person, to mitigate the risk of harm, and to take remedial action. 4. The United Kingdom competent authority shall promptly inform the Specialised Committee on Law Enforcement and Judicial Cooperation of any significant incident of accidental, unlawful or unauthorised access, processing or loss of PNR data. 5. The United Kingdom shall ensure that any breach of data security, in particular any breach leading to accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, or any unlawful forms of processing, are subject to effective and dissuasive corrective measures which may include sanctions. Article 550 Transparency and notification of passengers 1. The United Kingdom competent authority shall make the following available on its website: (a) a list of the legislation authorising the collection of PNR data; (b) the purposes for the collection of PNR data; (c) the manner of protecting PNR data; (d) the manner and extent to which PNR data may be disclosed; (e) information regarding the rights of access, correction, notation and redress; and (f) contact information for inquiries. 2. The Parties shall work with interested third parties, such as the aviation and air travel industry, to promote transparency at the time of booking regarding the purpose of the collection, processing and use of PNR data, and regarding how to request access, correction and redress. Air carriers shall provide passengers with clear and meaningful information in relation to the transfer of PNR data under this Title, including the details of the recipient authority, the purpose of the transfer and the right to request from the recipient authority, access to and correction of the personal data of the passenger that has been transferred. 3. Where PNR data retained in accordance with Article 552 has been used subject to the conditions set out in Article 553 or has been disclosed in accordance with Article 555 or Article 556, the United Kingdom shall notify the passengers concerned in writing, individually and within a reasonable time once such notification is no longer liable to jeopardise the investigations by the public authorities concerned to the extent that the relevant contact information of the passengers is available or can be retrieved, taking into account reasonable efforts. The notification shall include information on how the natural person concerned can seek administrative or judicial redress. Article 551 Automated processing of PNR data 1. The United Kingdom competent authority shall ensure that any automated processing of PNR data is based on non-discriminatory, specific and reliable pre-established models and criteria to enable it to: (a) arrive at results targeting natural persons who might be under a reasonable suspicion of involvement or participation in terrorism or serious crime; or (b) in exceptional circumstances, protect the vital interests of any natural person as set out in Article 544(2). 2. The United Kingdom competent authority shall ensure that the databases against which PNR data are compared are reliable, up to date and limited to those databases it uses in relation to the purposes set out in Article 544. 3. The United Kingdom shall not take any decision adversely affecting a natural person in a significant manner solely on the basis of automated processing of PNR data. Article 552 Retention of PNR data 1. The United Kingdom shall not retain PNR data for more than five years from the date that it receives the PNR data. 2. No later than six months after the transfer of the PNR data referred to in paragraph 1, all PNR data shall be depersonalised by masking out the following data elements which could serve to identify directly the passenger to whom the PNR data relate or any other natural person: (a) names, including the names of other passengers on the PNR and number of passengers on the PNR travelling together; (b) addresses, telephone numbers and electronic contact information of the passenger, the persons who made the flight reservation for the passenger, persons through whom the air passenger may be contacted and persons who are to be informed in the event of an emergency; (c) all available payment and billing information, to the extent that it contains any information which could serve to identify a natural person; (d) frequent flyer information; (e) other supplementary information (OSI), special service information (SSI) and special service request (SSR) information, to the extent that they contain any information which could serve to identify a natural person; and (f) any advance passenger information (API) data that have been collected. 3. The United Kingdom competent authority may unmask PNR data only if it is necessary to carry out investigations for the purposes set out in Article 544. Such unmasked PNR data shall be accessible only to a limited number of specifically authorised officials. 4. Notwithstanding paragraph 1, the United Kingdom shall delete the PNR data of passengers after their departure from the country unless a risk assessment indicates the need to retain such PNR data. In order to establish that need, the United Kingdom shall identify objective evidence from which it may be inferred that certain passengers present the existence of a risk in terms of the fight against terrorism and serious crime. 5. For the purposes of paragraph 4, unless information is available on the exact date of departure, the date of departure should be considered as the last day of the period of maximum lawful stay in the United Kingdom of the passenger concerned. 6. The use of the data retained under this Article is subject to the conditions laid down in Article 553. 7. An independent administrative body in the United Kingdom shall assess on a yearly basis the approach applied by the United Kingdom competent authority as regards the need to retain PNR data pursuant to paragraph 4. 8. Notwithstanding paragraphs 1, 2 and 4, the United Kingdom may retain PNR data required for any specific action, review, investigation, enforcement action, judicial proceeding, prosecution, or enforcement of penalties, until concluded. 9. The United Kingdom shall delete the PNR data at the end of the PNR data retention period. 10. Paragraph 11 applies due to the special circumstances that prevent the United Kingdom from making the technical adjustments necessary to transform the PNR processing systems which the United Kingdom operated whilst Union law applied to it into systems which would enable PNR data to be deleted in accordance with paragraph 4. 11. The United Kingdom may derogate from paragraph 4 on a temporary basis for an interim period, the duration of which is provided for in paragraph 13, pending the implementation by the United Kingdom of technical adjustments as soon as possible. During the interim period, the United Kingdom competent authority shall prevent the use of the PNR data that is to be deleted in accordance with paragraph 4 by applying the following additional safeguards to that PNR data: (a) the PNR data shall be accessible only to a limited number of authorised officials and only where necessary to determine whether the PNR data should be deleted in accordance with paragraph 4; (b) the request to use the PNR data shall be refused in cases where the data is to be deleted in accordance with paragraph 4, and no further access shall be granted to that data where the documentation referred to in point (d) of this paragraph indicates that an earlier request for use has been refused; (c) deletion of the PNR data shall be ensured as soon as possible using best efforts, taking into account the special circumstances referred to in paragraph 10; and (d) the following shall be documented in accordance with Article 554, and such documentation shall be made available to the independent administrative body referred to in paragraph 7 of this Article: (i) any requests to use the PNR data; (ii) the date and time of the access to the PNR data for the purpose of assessing whether deletion of the PNR data was required; (iii) that the request to use the PNR data was refused on the basis that the PNR data should have been deleted under paragraph 4, including the date and time of the refusal; and (iv) the date and time of the deletion of the PNR data in accordance with point (c) of this paragraph. 12. The United Kingdom shall provide to the Specialised Committee on Law Enforcement and Judicial Cooperation, nine months after the entry into force of this Agreement and again a year later if the interim period is extended for a further year: (a) a report from the independent administrative body referred to in paragraph 7 of this Article, which shall include the opinion of the United Kingdom supervisory authority referred to in Article 525(3) as to whether the safeguards provided for in paragraph 11 of this Article have been effectively applied; and (b) the assessment of the United Kingdom of whether the special circumstances referred to in paragraph 10 of this Article persist, together with a description of the efforts made to transform the PNR processing systems of the United Kingdom into systems which would enable PNR data to be deleted in accordance with paragraph 4 of this Article. 13. The Specialised Committee on Law Enforcement and Judicial Cooperation shall meet within one year of the entry into force of this Agreement to consider the report and assessment provided under paragraph 12. Where the special circumstances referred to in paragraph 10 persist, the Partnership Council shall extend the interim period referred to in paragraph 11 for one year. The Partnership Council shall extend the interim period for one further final year, under the same conditions and following the same procedure as for the first extension where, in addition, substantial progress has been made, although it has not yet been possible to transform the United Kingdom PNR processing systems into systems which would enable PNR data to be deleted in accordance with paragraph 4. 14. If the United Kingdom considers that a refusal by the Partnership Council to grant either of those extensions was not justified, it may suspend this Title with one month's notice. 15. On the third anniversary of the date of entry into force of this Agreement, paragraphs 10 to 14 shall cease to apply. Article 553 Conditions for the use of PNR data 1. The United Kingdom competent authority may use PNR data retained in accordance with Article 552 for purposes other than security and border control checks, including any disclosure under Article 555 and Article 556, only where new circumstances based on objective grounds indicate that the PNR data of one or more passengers might make an effective contribution to the attainment of the purposes set out in Article 544. 2. Use of PNR data by the United Kingdom competent authority in accordance with paragraph 1 shall be subject to prior review by a court or by an independent administrative body in the United Kingdom based on a reasoned request by the United Kingdom competent authority submitted within the domestic legal framework of procedures for the prevention, detection or prosecution of crime, except: (a) in cases of validly established urgency; or (b) for the purpose of verifying the reliability and currency of the pre-established models and criteria on which the automated processing of PNR data is based, or of defining new models and criteria for such processing. Article 554 Logging and documenting of PNR data processing The United Kingdom competent authority shall log and document all processing of PNR data. It shall only use such logging or documentation to: (a) self-monitor and to verify the lawfulness of data processing; (b) ensure proper data integrity; (c) ensure the security of data processing; and (d) ensure oversight. Article 555 Disclosure within the United Kingdom 1. The United Kingdom competent authority shall not disclose PNR data to other public authorities in the United Kingdom unless the following conditions are met: (a) the PNR data is disclosed to public authorities whose functions are directly related to the purposes set out in Article 544; (b) the PNR data is disclosed only on a case-by-case basis; (c) the disclosure is necessary, in the particular circumstances, for the purposes set out in Article 544; (d) only the minimum amount of PNR data necessary is disclosed; (e) the receiving public authority affords protection equivalent to the safeguards described in this Title; and (f) the receiving public authority does not disclose the PNR data to another entity unless the disclosure is authorised by the United Kingdom competent authority in accordance with the conditions laid down in this paragraph. 2. When transferring analytical information containing PNR data obtained under this Title, the safeguards set out in this Article shall apply. Article 556 Disclosure outside the United Kingdom 1. The United Kingdom shall ensure that the United Kingdom competent authority does not disclose PNR data to public authorities in third countries unless all the following conditions are met: (a) the PNR data is disclosed to public authorities whose functions are directly related to the purposes set out in Article 544; (b) the PNR data is disclosed only on a case-by-case basis; (c) the PNR data is disclosed only if necessary for the purposes set out in Article 544; (d) only the minimum amount of PNR data necessary is disclosed; and (e) the third country to which the PNR data is disclosed has either concluded an agreement with the Union that provides for the protection of personal data comparable to this Agreement or is subject to a decision of the European Commission pursuant to Union law that finds that the third country ensures an adequate level of data protection within the meaning of Union law. 2. As an exception to point (e) of paragraph 1, the United Kingdom competent authority may transfer PNR data to a third country if: (a) the head of that authority, or a senior official specifically mandated by the head, considers that the disclosure is necessary for the prevention and investigation of a serious and imminent threat to public security or to protect the vital interests of any natural person; and (b) the third country provides a written assurance, pursuant to an arrangement, agreement or otherwise, that the information shall be protected in line with the safeguards applicable under United Kingdom law to the processing of PNR data received from the Union, including those set out in this Title. 3. A transfer in accordance with paragraph 2 of this Article shall be documented. Such documentation shall be made available to the supervisory authority referred to in Article 525(3) on request, including the date and time of the transfer, information about the receiving authority, the justification for the transfer and the PNR data transferred. 4. If, in accordance with paragraph 1 or 2, the United Kingdom competent authority discloses PNR data collected under this Title that originates in a Member State, the United Kingdom competent authority shall notify the authorities of that Member State of the disclosure at the earliest appropriate opportunity. The United Kingdom shall make that notification in accordance with agreements or arrangements on law enforcement or information sharing between the United Kingdom and that Member State. 5. When transferring analytical information containing PNR data obtained under this Title, the safeguards set out in this Article shall apply. Article 557 Method of transfer Air carriers shall transfer PNR data to the United Kingdom competent authority exclusively on the basis of the \"push method\", a method by which air carriers transfer PNR data into the database of the United Kingdom competent authority, and in accordance with the following procedures to be observed by air carriers, by which they: (a) transfer PNR data by electronic means in compliance with the technical requirements of the United Kingdom competent authority or, in the case of a technical failure, by any other appropriate means ensuring an appropriate level of data security; (b) transfer PNR data using a mutually accepted messaging format; and (c) transfer PNR data in a secure manner using common protocols as required by the United Kingdom competent authority. Article 558 Frequency of transfer 1. The United Kingdom competent authority shall require air carriers to transfer the PNR data: (a) initially from no earlier than 96 hours before the scheduled flight service departure time; and (b) a maximum number of five times as specified by the United Kingdom competent authority. 2. The United Kingdom competent authority shall permit air carriers to limit the transfer referred to in point (b) of paragraph 1 to updates of the PNR data transferred as referred to in point (a) of that paragraph. 3. The United Kingdom competent authority shall inform air carriers of the specified times for the transfers. 4. In specific cases where there is an indication that additional access to PNR data is necessary to respond to a specific threat related to the purposes set out in Article 544, the United Kingdom competent authority may require an air carrier to provide PNR data prior to, between or after the scheduled transfers. In exercising that discretion, the United Kingdom competent authority shall act judiciously and proportionately, and shall use the method of transfer described in Article 557. Article 559 Cooperation The United Kingdom competent authority and the PIUs of the Member States shall cooperate to pursue the coherence of their PNR data processing regimes in a manner that further enhances the security of individuals in the United Kingdom, the Union and elsewhere. Article 560 Non-derogation This Title shall not be construed as derogating from any obligation between the United Kingdom and Member States or third countries to make or respond to a request under a mutual assistance instrument. Article 561 Consultation and review 1. The Parties shall advise each other of any measure that is to be enacted that may affect this Title. 2. When carrying out joint reviews of this Title as referred to in Article 691(1), the Parties shall pay particular attention to the necessity and proportionality of processing and retaining PNR data for each of the purposes set out in Article 544. The joint reviews shall also include an examination of how the United Kingdom competent authority has ensured that the pre-established models, criteria and databases referred to in Article 551 are reliable, relevant and current, taking into account statistical data. Article 562 Suspension of cooperation under this Title 1. In the event that either Party considers that the continued operation of this Title is no longer appropriate, it may notify the other Party accordingly of its intention to suspend the application of this Title. Following such notification, the Parties shall engage in consultations. 2. Where within 6 months of that notification the Parties have not reached a resolution, either Party may decide to suspend the application of this Title for a period of up to 6 months. Before the end of that period, the Parties may agree an extension of the suspension for an additional period of up to 6 months. If by the end of the suspension period the Parties have not reached a resolution with respect to this Title, this Title shall cease to apply on the first day of the month following the expiry of the suspension period, unless the notifying Party informs the other Party that it wishes to withdraw the notification. In that case, the provisions of this Title shall be reinstated. 3. If this Title is suspended under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what steps are needed to ensure that any cooperation initiated under this Title that is affected by the suspension is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Title before the provisions concerned by the suspension provisionally cease to apply, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the suspension takes effect. TITLE IV COOPERATION ON OPERATIONAL INFORMATION Article 563 Cooperation on Operational Information 1. The objective of this Title is for the Parties to ensure that the competent authorities of the United Kingdom and of the Member States are able to, subject to the conditions of their domestic law and within the scope of their powers, and to the extent that this is not provided for in other Titles of this Part, assist each other through the provision of relevant information for the purposes of: (a) the prevention, investigation, detection or prosecution of criminal offences; (b) the execution of criminal penalties; (c) safeguarding against, and the prevention of, threats to public safety; and (d) the prevention and combating of money laundering and the financing of terrorism. 2. For the purposes of this Title, a \"competent authority\" means a domestic police, customs or other authority that is competent under domestic law to undertake activities for the purposes set out in paragraph 1. 3. Information, including information on wanted and missing persons as well as objects, may be requested by a competent authority of the United Kingdom or of a Member State, or provided spontaneously to a competent authority of the United Kingdom or of a Member State. Information may be provided in response to a request or spontaneously, subject to the conditions of the domestic law which applies to the providing competent authority and within the scope of its powers. 4. Information may be requested and provided to the extent that the conditions of the domestic law which applies to the requesting or providing competent authority do not stipulate that the request or provision of information has to be made or channelled via judicial authorities. 5. In urgent cases, the providing competent authority shall respond to a request, or provide information spontaneously, as soon as possible. 6. A competent authority of the requesting State may, in accordance with relevant domestic law, at the time of making the request or at a later point in time, seek consent from the providing State for the information to be used for evidential purposes in proceedings before a judicial authority. The providing State may, subject to the conditions set out in Title VIII and the conditions of the domestic law which applies to it, consent to the information being used for evidential purposes before a judicial authority in the requesting State. Equally, where information is provided spontaneously, the providing State may consent to the information being used for evidential purposes in proceedings before a judicial authority in the receiving State. Where consent is not given under this paragraph, the information received shall not be used for evidential purposes in proceedings before a judicial authority. 7. The providing competent authority may, under relevant domestic law, impose conditions on the use of the information provided. 8. A competent authority may provide under this Title any type of information which it holds, subject to the conditions of the domestic law which applies to it and within the scope of its powers. This may include information from other sources, only if onward transfer of that information is permitted in the framework under which it was obtained by the providing competent authority. 9. Information may be provided under this Title via any appropriate communication channel, including the secure communication line for the purpose of provision of information through Europol. 10. This Article shall not affect the operation or conclusion of bilateral agreements between the United Kingdom and Member States, provided that the Member States act in compliance with Union law. It shall also not affect any other powers which are available to the competent authorities of the United Kingdom or of the Member States under applicable domestic or international law to provide assistance through the sharing of information for the purposes set out in paragraph 1. TITLE V COOPERATION WITH EUROPOL Article 564 Objective The objective of this Title is to establish cooperative relations between Europol and the competent authorities of the United Kingdom in order to support and strengthen the action by the Member States and the United Kingdom, as well as their mutual cooperation in preventing and combating serious crime, terrorism and forms of crime which affect a common interest covered by a Union policy, as referred to in Article 566. Article 565 Definitions For the purposes of this Title, the following definitions apply: (a) \"Europol\" means the European Union Agency for Law Enforcement Cooperation, set up under Regulation (EU) 2016/794 of the European Parliament and of the Council (79) (the \"Europol Regulation\"); (b) \"competent authority\" means, for the Union, Europol and, for the United Kingdom, a domestic law enforcement authority responsible under domestic law for preventing and combating criminal offences; Article 566 Forms of crime 1. The cooperation established under this Title relates to the forms of crime within Europol's competence, as listed in Annex 41, including related criminal offences. 2. Related criminal offences are criminal offences committed in order to procure the means of committing the forms of crime referred to in paragraph 1, criminal offences committed in order to facilitate or carry out such crimes, and criminal offences committed to ensure impunity for such crimes. 3. Where the list of forms of crime for which Europol is competent under Union law is changed, the Specialised Committee on Law Enforcement and Judicial Cooperation may, upon a proposal from the Union, amend Annex 41 accordingly from the date when the change to Europol's competence enters into effect. Article 567 Scope of cooperation The cooperation may, in addition to the exchange of personal data under the conditions laid down in this Title and in accordance with the tasks of Europol as outlined in the Europol Regulation, in particular include: (a) the exchange of information such as specialist knowledge; (b) general situation reports; (c) results of strategic analysis; (d) information on criminal investigation procedures; (e) information on crime prevention methods; (f) participation in training activities; and (g) the provision of advice and support in individual criminal investigations as well as operational cooperation. Article 568 National contact point and liaison officers 1. The United Kingdom shall designate a national contact point to act as the central point of contact between Europol and the competent authorities of the United Kingdom. 2. The exchange of information between Europol and the competent authorities of the United Kingdom shall take place between Europol and the national contact point referred to in paragraph 1. This does not preclude, however, direct exchanges of information between Europol and the competent authorities of the United Kingdom, if considered appropriate by both Europol and the relevant competent authorities. 3. The national contact point shall also be the central point of contact in respect of review, correction and deletion of personal data. 4. To facilitate the cooperation established under this Title, the United Kingdom shall second one or more liaison officers to Europol. Europol may second one or more liaison officers to the United Kingdom. 5. The United Kingdom shall ensure that its liaison officers have speedy and, where technically possible, direct access to the relevant domestic databases of the United Kingdom that are necessary for them to fulfil their tasks. 6. The number of liaison officers, the details of their tasks, their rights and obligations and the costs involved shall be governed by working arrangements concluded between Europol and the competent authorities of the United Kingdom as referred to in Article 577. 7. Liaison officers from the United Kingdom and representatives of the competent authorities of the United Kingdom may be invited to operational meetings. Member State liaison officers and third-country liaison officers, representatives of competent authorities from the Member States and third countries, Europol staff and other stakeholders may attend meetings organised by the liaison officers or the competent authorities of the United Kingdom. Article 569 Exchanges of information 1. Exchanges of information between the competent authorities shall comply with the objective and provisions of this Title. Personal data shall be processed only for the specific purposes referred to in paragraph 2. 2. The competent authorities shall clearly indicate, at the latest at the moment of transferring personal data, the specific purpose or purposes for which the personal data are being transferred. For transfers to Europol, the purpose or purposes of such transfer shall be specified in line with the specific purposes of processing set out in the Europol Regulation. If the transferring competent authority has not done so, the receiving competent authority, in agreement with the transferring authority, shall process the personal data in order to determine their relevance as well as the purpose or purposes for which it is to be further processed. The competent authorities may process personal data for a purpose other than the purpose for which they have been provided only if authorised to do so by the transferring competent authority. 3. The competent authorities receiving the personal data shall give an undertaking stating that such data will be processed only for the purpose for which they were transferred. The personal data shall be deleted as soon as they are no longer necessary for the purpose for which they were transferred. 4. Europol and the competent authorities of the United Kingdom shall determine without undue delay, and in any event no later than six months after receipt of the personal data, if and to what extent those personal data are necessary for the purpose for which they were transferred and inform the transferring authority accordingly. Article 570 Restrictions on access to and further use of transferred personal data 1. The transferring competent authority may indicate, at the moment of transferring personal data, any restriction on access thereto or the use to be made thereof, in general or specific terms, including as regards its onward transfer, erasure or destruction after a certain period of time, or its further processing. Where the need for such restrictions becomes apparent after the personal data have been transferred, the transferring competent authority shall inform the receiving competent authority accordingly. 2. The receiving competent authority shall comply with any restriction on access or further use of the personal data indicated by the transferring competent authority as described in paragraph 1. 3. Each Party shall ensure that information transferred under this Title was collected, stored and transferred in accordance with its respective legal framework. Each Party shall ensure, as far as possible, that such information has not been obtained in violation of human rights. Nor shall such information be transferred if, to the extent reasonably foreseeable, it could be used to request, hand down or execute a death penalty or any form of cruel or inhuman treatment. Article 571 Different categories of data subjects 1. The transfer of personal data in respect of victims of a criminal offence, witnesses or other persons who can provide information concerning criminal offences, or in respect of persons under the age of 18, shall be prohibited unless such transfer is strictly necessary and proportionate in individual cases for preventing or combating a criminal offence. 2. The United Kingdom and Europol shall each ensure that the processing of personal data under paragraph 1 is subject to additional safeguards, including restrictions on access, additional security measures and limitations on onward transfers. Article 572 Facilitation of flow of personal data between the United Kingdom and Europol In the interest of mutual operational benefits, the Parties shall endeavour to cooperate in the future with a view to ensuring that data exchanges between Europol and the competent authorities of the United Kingdom can take place as quickly as possible, and to consider the incorporation of any new processes and technical developments which might assist with that objective, while taking account of the fact that the United Kingdom is not a Member State. Article 573 Assessment of reliability of the source and accuracy of information 1. The competent authorities shall indicate as far as possible, at the latest at the moment of transferring the information, the reliability of the source of the information on the basis of the following criteria: (a) where there is no doubt as to the authenticity, trustworthiness and competence of the source, or if the information is provided by a source which has proved to be reliable in all instances; (b) where the information is provided by a source which has in most instances proved to be reliable; (c) where the information is provided by a source which has in most instances proved to be unreliable; (d) where the reliability of the source cannot be assessed. 2. The competent authorities shall indicate as far as possible, at the latest at the moment of transferring the information, the accuracy of the information on the basis of the following criteria: (a) information the accuracy of which is not in doubt; (b) information known personally to the source but not known personally to the official passing it on; (c) information not known personally to the source but corroborated by other information already recorded; (d) information not known personally to the source and which cannot be corroborated. 3. Where the receiving competent authority, on the basis of information already in its possession, comes to the conclusion that the assessment of information or of its source supplied by the transferring competent authority in accordance with paragraphs 1 and 2 needs correction, it shall inform that competent authority and shall attempt to agree on an amendment to the assessment. The receiving competent authority shall not change the assessment of information received or of its source without such agreement. 4. If a competent authority receives information without an assessment, it shall attempt as far as possible and where possible in agreement with the transferring competent authority to assess the reliability of the source or the accuracy of the information on the basis of information already in its possession. 5. If no reliable assessment can be made, the information shall be evaluated as provided for in point (d) of paragraph 1 and point (d) of paragraph 2. Article 574 Security of the information exchange 1. The technical and organisational measures put in place to ensure the security of the information exchange under this Title shall be laid down in administrative arrangements between Europol and the competent authorities of the United Kingdom as referred to in Article 577. 2. The Parties agree on the establishment, implementation and operation of a secure communication line for the purpose of the exchange of information between Europol and the competent authorities of the United Kingdom. 3. Administrative arrangements between Europol and the competent authorities of the United Kingdom as referred to in Article 576 shall regulate the secure communication line's terms and conditions of use. Article 575 Liability for unauthorised or incorrect personal data processing 1. The competent authorities shall be liable, in accordance with their respective legal frameworks, for any damage caused to an individual as a result of legal or factual errors in information exchanged. In order to avoid liability under their respective legal frameworks vis-\u00e0-vis an injured party, neither Europol nor the competent authorities of the United Kingdom may plead that the other competent authority had transferred inaccurate information. 2. If damages are awarded either against Europol or against the competent authorities of the United Kingdom because of the use by either of them of information which was erroneously communicated by the other, or communicated as a result of a failure on the part of the other to comply with their obligations, the amount paid as compensation under paragraph 1 either by Europol or by the competent authorities of the United Kingdom shall be repaid by the other, unless the information was used in breach of this Title. 3. Europol and the competent authorities of the United Kingdom shall not require each other to pay for punitive or non-compensatory damages under paragraphs 1 and 2. Article 576 Exchange of classified and sensitive non-classified information The exchange and protection of classified and sensitive non-classified information, if necessary under this Title, shall be regulated in working and administrative arrangements as referred to in Article 577 between Europol and the competent authorities of the United Kingdom. Article 577 Working and administrative arrangements 1. The details of cooperation between the United Kingdom and Europol, as appropriate to complement and implement the provisions of this Title, shall be the subject of working arrangements in accordance with Article 23(4) of the Europol Regulation and administrative arrangements in accordance with Article 25(1) of the Europol Regulation concluded between Europol and the competent authorities of the United Kingdom. 2. Without prejudice to any provision in this Title and while reflecting the status of the United Kingdom as not being a Member State, Europol and the competent authorities of the United Kingdom shall, subject to a decision by Europol's Management Board, include, in working arrangements or administrative arrangements, as the case may be, provisions complementing or implementing this Title, in particular allowing for: (a) consultations between Europol and one or more representatives of the national contact point of the United Kingdom on policy issues and matters of common interest for the purpose of realising their objectives and coordinating their respective activities, and of furthering cooperation between Europol and the competent authorities of the United Kingdom; (b) the participation of one or more representatives of the United Kingdom as observer or observers in specific meetings of the Heads of Europol National Units in line with the rules of proceedings of such meetings; (c) the association of one or more representatives of the United Kingdom to operational analysis projects, in accordance with the rules set out by the appropriate Europol governance bodies; (d) the specification of liaison officers' tasks, their rights and obligations and the costs involved; or (e) cooperation between the competent authorities of the United Kingdom and Europol in the event of privacy or security breaches. 3. The substance of working and administrative arrangements may be set out together in one document. Article 578 Notification of implementation 1. The United Kingdom and Europol shall each make publicly available a document setting out in an intelligible form the provisions regarding the processing of personal data transferred under this Title including the means available for the exercise of the rights of data subjects, and shall each ensure that a copy of that document be provided to the other. 2. Where not already in place, the United Kingdom and Europol shall adopt rules specifying how compliance with the provisions regarding the processing of personal data will be enforced in practice. The United Kingdom and Europol shall each send a copy of those rules to the other and to the respective supervisory authorities. Article 579 Powers of Europol Nothing in this Title shall be construed as creating an obligation on Europol to cooperate with the competent authorities of the United Kingdom beyond Europol's competence as set out in the relevant Union law. TITLE VI COOPERATION WITH EUROJUST Article 580 Objective The objective of this Title is to establish cooperation between Eurojust and the competent authorities of the United Kingdom in combating serious crimes as referred to in Article 582. Article 581 Definitions For the purposes of this Title, the following definitions apply: (a) \"Eurojust\" means the European Union Agency for Criminal Justice Cooperation, set up under Regulation (EU) 2018/1727 of the European Parliament and of the Council (80) (the \"Eurojust Regulation\"); (b) \"competent authority\" means, for the Union, Eurojust, represented by the College or a National Member and, for the United Kingdom, a domestic authority with responsibilities under domestic law relating to the investigation and prosecution of criminal offences; (c) \"College\" means the College of Eurojust, as referred to in the Eurojust Regulation; (d) \"National Member\" means the National Member seconded to Eurojust by each Member State, as referred to in the Eurojust Regulation; (e) \"Assistant\" means a person who may assist a National Member and the National Member's Deputy, or the Liaison Prosecutor, as referred to in the Eurojust Regulation and in Article 585(3) respectively; (f) \"Liaison Prosecutor\" means a public prosecutor seconded by the United Kingdom to Eurojust and subject to the domestic law of the United Kingdom as regards the public prosecutor's status; (g) \"Liaison Magistrate\" means a magistrate posted by Eurojust to the United Kingdom in accordance with Article 586; (h) \"Domestic Correspondent for Terrorism Matters\" means the contact point designated by the United Kingdom in accordance with Article 584, responsible for handling correspondence related to terrorism matters. Article 582 Forms of crime 1. The cooperation established under this Title relates to the forms of serious crime within the competence of Eurojust, as listed in Annex 42, including related criminal offences. 2. Related criminal offences are the criminal offences committed in order to procure the means of committing forms of serious crime referred to in paragraph 1, criminal offences committed in order to facilitate or commit such serious crimes, and criminal offences committed to ensure impunity for such serious crimes. 3. Where the list of forms of serious crime for which Eurojust is competent under Union law is changed, the Specialised Committee on Law Enforcement and Judicial Cooperation may, upon a proposal from the Union, amend Annex 42 accordingly from the date when the change to Eurojust's competence enters into effect. Article 583 Scope of cooperation The Parties shall ensure that Eurojust and the competent authorities of the United Kingdom cooperate in the fields of activity set out in Articles 2 and 54 of the Eurojust Regulation and in this Title. Article 584 Contact points to Eurojust 1. The United Kingdom shall put in place or appoint at least one contact point to Eurojust within the competent authorities of the United Kingdom. 2. The United Kingdom shall designate one of its contact points as the United Kingdom Domestic Correspondent for Terrorism Matters. Article 585 Liaison Prosecutor 1. To facilitate the cooperation established under this Title, the United Kingdom shall second a Liaison Prosecutor to Eurojust. 2. The mandate and the duration of the secondment shall be determined by the United Kingdom. 3. The Liaison Prosecutor may be assisted by up to five Assistants, reflecting the volume of cooperation. When necessary, Assistants may replace the Liaison Prosecutor or act on the Liaison Prosecutor's behalf. 4. The United Kingdom shall inform Eurojust of the nature and extent of the judicial powers of the Liaison Prosecutor and the Liaison Prosecutor's Assistants within the United Kingdom to accomplish their tasks in accordance with this Title. The United Kingdom shall establish the competence of its Liaison Prosecutor and the Liaison Prosecutor's Assistants to act in relation to foreign judicial authorities. 5. The Liaison Prosecutor and the Liaison Prosecutor's Assistants shall have access to the information contained in the domestic criminal record, or in any other register of the United Kingdom, in accordance with domestic law in the case of a prosecutor or person of equivalent competence. 6. The Liaison Prosecutor and the Liaison Prosecutor's Assistants shall have the power to contact the competent authorities of the United Kingdom directly. 7. The number of Assistants referred to in paragraph 3 of this Article, the details of the tasks of the Liaison Prosecutor and the Liaison Prosecutor's Assistants, their rights and obligations and the costs involved shall be governed by a working arrangement concluded between Eurojust and the competent authorities of the United Kingdom as referred to in Article 594. 8. The working documents of the Liaison Prosecutor and the Liaison Prosecutor's Assistants shall be held inviolable by Eurojust. Article 586 Liaison Magistrate 1. For the purpose of facilitating judicial cooperation with the United Kingdom in cases in which Eurojust provides assistance, Eurojust may post a Liaison Magistrate to the United Kingdom, in accordance with Article 53 of the Eurojust Regulation. 2. The details of the Liaison Magistrate's tasks referred to in paragraph 1 of this Article, the Liaison Magistrate's rights and obligations and the costs involved, shall be governed by a working arrangement concluded between Eurojust and the competent authorities of the United Kingdom as referred to in Article 594. Article 587 Operational and strategic meetings 1. The Liaison Prosecutor, the Liaison Prosecutor's Assistants, and representatives of other competent authorities of the United Kingdom, including the contact point to Eurojust, may participate in meetings with regard to strategic matters at the invitation of the President of Eurojust and in meetings with regard to operational matters with the approval of the National Members concerned. 2. National Members, their Deputies and Assistants, the Administrative Director of Eurojust and Eurojust staff may attend meetings organised by the Liaison Prosecutor, the Liaison Prosecutor's Assistants, or other competent authorities of the United Kingdom, including the contact point to Eurojust. Article 588 Exchange of non-personal data Eurojust and the competent authorities of the United Kingdom may exchange any non-personal data in so far as those data are relevant for the cooperation under this Title, and subject to any restrictions pursuant to Article 593. Article 589 Exchange of personal data 1. Personal data requested and received by competent authorities under this Title shall be processed by them only for the objectives set out in Article 580, for the specific purposes referred to in paragraph 2 of this Article and subject to the restrictions on access or further use referred to in paragraph 3 of this Article. 2. The transferring competent authority shall clearly indicate, at the latest at the moment of transferring personal data, the specific purpose or purposes for which the data are being transferred. 3. The transferring competent authority may indicate, at the moment of transferring personal data, any restriction on access thereto or the use to be made thereof, in general or specific terms, including as regards its onward transfer, erasure or destruction after a certain period of time, or its further processing. Where the need for such restrictions becomes apparent after the personal data have been provided, the transferring authority shall inform the receiving authority accordingly. 4. The receiving competent authority shall comply with any restriction on access or further use of the personal data indicated by the transferring competent authority as provided for in paragraph 3. Article 590 Channels of transmission 1. Information shall be exchanged: (a) either between the Liaison Prosecutor or the Liaison Prosecutor's Assistants or, if none is appointed or otherwise available, the United Kingdom's contact point to Eurojust and the National Members concerned or the College; (b) if Eurojust has posted a Liaison Magistrate to the United Kingdom, between the Liaison Magistrate and any competent authority of the United Kingdom; in that event, the Liaison Prosecutor shall be informed of any such information exchanges; or (c) directly between a competent authority in the United Kingdom and the National Members concerned or the College; in that event, the Liaison Prosecutor and, if applicable, the Liaison Magistrate shall be informed of any such information exchanges. 2. Eurojust and the competent authorities of the United Kingdom may agree to use other channels for the exchange of information in particular cases. 3. Eurojust and the competent authorities of the United Kingdom shall each ensure that their respective representatives are authorised to exchange information at the appropriate level and in accordance with United Kingdom law and the Eurojust Regulation respectively, and are adequately screened. Article 591 Onward transfers The competent authorities of the United Kingdom and Eurojust shall not communicate any information provided by the other to any third country or international organisation without the consent of whichever of the competent authorities of the United Kingdom or Eurojust provided the information and without appropriate safeguards regarding the protection of personal data. Article 592 Liability for unauthorised or incorrect personal data processing 1. The competent authorities shall be liable, in accordance with their respective legal frameworks, for any damage caused to an individual as a result of legal or factual errors in information exchanged. In order to avoid liability under their respective legal frameworks vis-\u00e0-vis an injured party, neither Eurojust nor the competent authorities of the United Kingdom may plead that the other competent authority had transferred inaccurate information. 2. If damages are awarded against any competent authority because of its use of information which was erroneously communicated by the other, or communicated as a result of a failure on the part of the other to comply with their obligations, the amount paid as compensation under paragraph 1 by the competent authority shall be repaid by the other, unless the information was used in breach of this Title. 3. Eurojust and the competent authorities of the United Kingdom shall not require each other to pay for punitive or non-compensatory damages under paragraphs 1 and 2. Article 593 Exchange of classified and sensitive non-classified information The exchange and protection of classified and sensitive non-classified information, if necessary under this Title, shall be regulated by a working arrangement as referred to in Article 594 concluded between Eurojust and the competent authorities of the United Kingdom. Article 594 Working arrangement The modalities of cooperation between the Parties as appropriate to implement this Title shall be the subject of a working arrangement concluded between Eurojust and the competent authorities of the United Kingdom in accordance with Articles 47(3) and 56(3) of the Eurojust Regulation. Article 595 Powers of Eurojust Nothing in this Title shall be construed as creating an obligation on Eurojust to cooperate with the competent authorities of the United Kingdom beyond Eurojust\u2018s competence as set out in the relevant Union law. TITLE VII SURRENDER Article 596 Objective The objective of this Title is to ensure that the extradition system between the Member States, on the one side, and the United Kingdom, on the other side, is based on a mechanism of surrender pursuant to an arrest warrant in accordance with the terms of this Title. Article 597 Principle of proportionality Cooperation through the arrest warrant shall be necessary and proportionate, taking into account the rights of the requested person and the interests of the victims, and having regard to the seriousness of the act, the likely penalty that would be imposed and the possibility of a State taking measures less coercive than the surrender of the requested person particularly with a view to avoiding unnecessarily long periods of pre-trial detention. Article 598 Definitions For the purposes of this Title, the following definitions apply: (a) \"arrest warrant\" means a judicial decision issued by a State with a view to the arrest and surrender by another State of a requested person, for the purposes of conducting a criminal prosecution or executing a custodial sentence or detention order; (b) \"judicial authority\" means an authority that is, under domestic law, a judge, a court or a public prosecutor. A public prosecutor is considered a judicial authority only to the extent that domestic law so provides; (c) \"executing judicial authority\" means the judicial authority of the executing State which is competent to execute the arrest warrant by virtue of the domestic law of that State; (d) \"issuing judicial authority\" means the judicial authority of the issuing State which is competent to issue an arrest warrant by virtue of the domestic law of that State. Article 599 Scope 1. An arrest warrant may be issued for acts punishable by the law of the issuing State by a custodial sentence or a detention order for a maximum period of at least 12 months or, where a sentence has been passed or a detention order has been made, for sentences or detention orders of at least four months. 2. Without prejudice to paragraphs 3 and 4, surrender is subject to the condition that the acts for which the arrest warrant has been issued constitute an offence under the law of the executing State, whatever the constituent elements or however it is described. 3. Subject to Article 600, points (b) to (h) of Article 601(1), and Articles 602, 603 and 604, a State shall not refuse to execute an arrest warrant issued in relation to the following behaviour where such behaviour is punishable by deprivation of liberty or a detention order of a maximum period of at least 12 months: (a) the behaviour of any person who contributes to the commission by a group of persons acting with a common purpose of one or more offences in the field of terrorism referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism, done at Strasbourg on 27 January 1977, or in relation to illicit trafficking in narcotic drugs and psychotropic substances, or murder, grievous bodily injury, kidnapping, illegal restraint, hostage-taking or rape, even where that person does not take part in the actual execution of the offence or offences concerned; such contribution must be intentional and made with the knowledge that the participation will contribute to the achievement of the group's criminal activities; or (b) terrorism as defined in Annex 45. 4. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that, on the basis of reciprocity, the condition of double criminality referred to in paragraph 2 will not be applied, provided that the offence on which the warrant is based is: (a) one of the offences listed in paragraph 5, as defined by the law of the issuing State; and (b) punishable in the issuing State by a custodial sentence or a detention order for a maximum period of at least three years. 5. The offences referred to in paragraph 4 are: \u2014 participation in a criminal organisation; \u2014 terrorism as defined in Annex 45; \u2014 trafficking in human beings; \u2014 sexual exploitation of children and child pornography; \u2014 illicit trafficking in narcotic drugs and psychotropic substances; \u2014 illicit trafficking in weapons, munitions and explosives; \u2014 corruption, including bribery; \u2014 fraud, including that affecting the financial interests of the United Kingdom, a Member State or the Union; \u2014 laundering of the proceeds of crime; \u2014 counterfeiting currency; \u2014 computer-related crime; \u2014 environmental crime, including illicit trafficking in endangered animal species and endangered plant species and varieties; \u2014 facilitation of unauthorised entry and residence; \u2014 murder; \u2014 grievous bodily injury; \u2014 illicit trade in human organs and tissue; \u2014 kidnapping, illegal restraint and hostage-taking; \u2014 racism and xenophobia; \u2014 organised or armed robbery; \u2014 illicit trafficking in cultural goods, including antiques and works of art; \u2014 swindling; \u2014 racketeering and extortion; \u2014 counterfeiting and piracy of products; \u2014 forgery of administrative documents and trafficking therein; \u2014 forgery of means of payment; \u2014 illicit trafficking in hormonal substances and other growth promoters; \u2014 illicit trafficking in nuclear or radioactive materials; \u2014 trafficking in stolen vehicles; \u2014 rape; \u2014 arson; \u2014 crimes within the jurisdiction of the International Criminal Court; \u2014 unlawful seizure of aircraft, ships or spacecraft; and \u2014 sabotage. Article 600 Grounds for mandatory non-execution of the arrest warrant The execution of the arrest warrant shall be refused: (a) if the offence on which the arrest warrant is based is covered by an amnesty in the executing State, where that State had jurisdiction to prosecute the offence under its own criminal law; (b) if the executing judicial authority is informed that the requested person has been finally judged by a State in respect of the same acts, provided that, if a penalty has been imposed, it has been enforced, is in the process of being enforced or can no longer be enforced under the law of the sentencing State; or (c) if the person who is the subject of the arrest warrant may not, owing to the person's age, be held criminally responsible for the acts on which the arrest warrant is based under the law of the executing State. Article 601 Other grounds for non-execution of the arrest warrant 1. The execution of the arrest warrant may be refused: (a) if, in one of the cases referred to in Article 599(2), the act on which the arrest warrant is based does not constitute an offence under the law of the executing State; however, in relation to taxes or duties, customs and exchange, the execution of the arrest warrant shall not be refused on the grounds that the law of the executing State does not impose the same kind of tax or duty or does not contain the same type of rules as regards taxes or duties, customs and exchange regulations as the law of the issuing State; (b) if the person who is the subject of the arrest warrant is being prosecuted in the executing State for the same act as that on which the arrest warrant is based; (c) if the judicial authorities of the executing State have decided either not to prosecute for the offence on which the arrest warrant is based or to halt proceedings, or if a final judgment which prevents further proceedings has been passed upon the requested person in a State in respect of the same acts; (d) if the criminal prosecution or punishment of the requested person is statute-barred under the law of the executing State and the acts fall within the jurisdiction of that State under its own criminal law; (e) if the executing judicial authority is informed that the requested person has been finally judged by a third country in respect of the same acts provided that, if a penalty has been imposed, it has been enforced, is in the process of being enforced or can no longer be enforced under the law of the sentencing country; (f) if the arrest warrant has been issued for the purposes of execution of a custodial sentence or detention order and the requested person is staying in, or is a national or a resident of the executing State and that State undertakes to execute the sentence or detention order in accordance with its domestic law; if consent of the requested person to the transfer of the sentence or detention order to the executing State is required, the executing State may refuse to execute the arrest warrant only after the requested person consents to the transfer of the sentence or detention order; (g) if the arrest warrant relates to offences which: (i) are regarded by the law of the executing State as having been committed in whole or in part in the territory of the executing State or in a place treated as such; or (ii) have been committed outside the territory of the issuing State, and the law of the executing State does not allow prosecution for the same offences if committed outside its territory; (h) if there are reasons to believe on the basis of objective elements that the arrest warrant has been issued for the purpose of prosecuting or punishing a person on the grounds of the person's sex, race, religion, ethnic origin, nationality, language, political opinions or sexual orientation, or that that person's position may be prejudiced for any of those reasons; (i) if the arrest warrant has been issued for the purpose of executing a custodial sentence or a detention order and the requested person did not appear in person at the trial resulting in the decision, unless the arrest warrant states that the person, in accordance with further procedural requirements defined in the domestic law of the issuing State: (i) in due time: (A) either was summoned in person and thereby informed of the scheduled date and place of the trial which resulted in the decision, or by other means actually received official information of the scheduled date and place of that trial in such a manner that it was unequivocally established that the person was aware of the date and place of the scheduled trial ; and (B) was informed that a decision may be handed down if that person did not appear for the trial; or (ii) being aware of the date and place of the scheduled trial, had given a mandate to a lawyer, who was either appointed by the person concerned or by the State, to defend him or her at the trial, and was indeed defended by that lawyer at the trial; or (iii) after being served with the decision and being expressly informed about the right to a retrial or appeal in which the person has the right to participate and which allows the merits of the case, including fresh evidence, to be re-examined, and which may lead to the original decision being reversed: (A) expressly stated that the person did not contest the decision; or (B) did not request a retrial or appeal within the applicable time frame; or (iv) was not personally served with the decision but: (A) will be personally served with it without delay after the surrender and will be expressly informed of the right to a retrial or appeal in which the person has the right to participate and which allows the merits of the case, including fresh evidence, to be re-examined, and which may lead to the original decision being reversed; and (B) will be informed of the time frame within which the person has to request such a retrial or appeal, as mentioned in the relevant arrest warrant. 2. Where the arrest warrant is issued for the purpose of executing a custodial sentence or detention order under the conditions in point (i) (iv) of paragraph 1 and the person concerned has not previously received any official information about the existence of the criminal proceedings against him or her, that person may, when being informed about the content of the arrest warrant, request to receive a copy of the judgment before being surrendered. Immediately after having been informed about the request, the issuing authority shall provide the copy of the judgment via the executing authority to the person concerned. The request of the person concerned shall neither delay the surrender procedure nor delay the decision to execute the arrest warrant. The provision of the judgment to the person concerned shall be for information purposes only; it shall not be regarded as a formal service of the judgment nor actuate any time limits applicable for requesting a retrial or appeal. 3. Where a person is surrendered under the conditions in point (i) (iv) of paragraph 1 and that person has requested a retrial or appeal, until those proceedings are finalised the detention of that person awaiting such retrial or appeal shall be reviewed in accordance with the domestic law of the issuing State, either on a regular basis or upon request of the person concerned. Such a review shall in particular include the possibility of suspension or interruption of the detention. The retrial or appeal shall begin within due time after the surrender. Article 602 Political offence exception 1. The execution of an arrest warrant may not be refused on the grounds that the offence may be regarded by the executing State as a political offence, as an offence connected with a political offence or as an offence inspired by political motives. 2. However, the United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that paragraph 1 will be applied only in relation to: (a) the offences referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism; (b) offences of conspiracy or association to commit one or more of the offences referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism, if those offences of conspiracy or association correspond to the description of behaviour referred to in Article 599(3) of this Agreement; and (c) terrorism as defined in Annex 45 to this Agreement. 3. Where an arrest warrant has been issued by a State having made a notification as referred to in paragraph 2 or by a State on behalf of which such a notification has been made, the State executing the arrest warrant may apply reciprocity. Article 603 Nationality exception 1. The execution of an arrest warrant may not be refused on the grounds that the requested person is a national of the executing State. 2. The United Kingdom, and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that that State's own nationals will not be surrendered or that the surrender of their own nationals will be authorised only under certain specified conditions. The notification shall be based on reasons related to the fundamental principles or practice of the domestic legal order of the United Kingdom or the State on behalf of which a notification was made. In such a case, the Union, on behalf of any of its Member States or the United Kingdom, as the case may be, may notify the Specialised Committee on Law Enforcement and Judicial Cooperation within a reasonable time after the receipt of the other Party's notification that the executing judicial authorities of the Member State or the United Kingdom, as the case may be, may refuse to surrender its nationals to that State or that surrender shall be authorised only under certain specified conditions. 3. In circumstances where a State has refused to execute an arrest warrant on the basis that, in the case of the United Kingdom, it has made a notification or, in the case of a Member State, the Union has made a notification on its behalf, as referred to in paragraph 2, that State shall consider instituting proceedings against its own national which are commensurate with the subject matter of the arrest warrant, having taken into account the views of the issuing State. In circumstances where a judicial authority decides not to institute such proceedings, the victim of the offence on which the arrest warrant is based shall be able to receive information on the decision in accordance with the applicable domestic law. 4. Where a State's competent authorities institute proceedings against its own national in accordance with paragraph 3, that State shall ensure that its competent authorities are able to take appropriate measures to assist the victims and witnesses in circumstances where they are residents of another State, particularly with regard to the way in which the proceedings are conducted. Article 604 Guarantees to be given by the issuing State in particular cases The execution of the arrest warrant by the executing judicial authority may be subject to the following guarantees: (a) if the offence on which the arrest warrant is based is punishable by a custodial life sentence or a lifetime detention order in the issuing State, the executing State may make the execution of the arrest warrant subject to the condition that the issuing State gives a guarantee deemed sufficient by the executing State that the issuing State will review the penalty or measure imposed, on request or at the latest after 20 years, or will encourage the application of measures of clemency for which the person is entitled to apply under the law or practice of the issuing State, aiming at the non-execution of such penalty or measure; (b) if a person who is the subject of an arrest warrant for the purposes of prosecution is a national or resident of the executing State, the surrender of that person may be subject to the condition that the person, after being heard, is returned to the executing State in order to serve there the custodial sentence or detention order passed against him or her in the issuing State; if the consent of the requested person to the transfer of the sentence or detention order to the executing State is required, the guarantee that the person be returned to the executing State to serve the person's sentence is subject to the condition that the requested person, after being heard, consents to be returned to the executing State; (c) if there are substantial grounds for believing that there is a real risk to the protection of the fundamental rights of the requested person, the executing judicial authority may require, as appropriate, additional guarantees as to the treatment of the requested person after the person's surrender before it decides whether to execute the arrest warrant. Article 605 Recourse to the central authority 1. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation of, in the case of the United Kingdom, its central authority and, in the case of the Union, the central authority for each State, having designated such an authority, or, if the legal system of the relevant State so provides, of more than one central authority to assist the competent judicial authorities. 2. When notifying the Specialised Committee on Law Enforcement and Judicial Cooperation under paragraph 1, the United Kingdom and the Union, acting on behalf of any of its Member States, may each indicate that, as a result of the organisation of the internal judicial system of the relevant States, the central authority or central authorities are responsible for the administrative transmission and receipt of arrest warrants as well as for all other official correspondence relating to the administrative transmission and receipt of arrest warrants. Such indication shall be binding upon all the authorities of the issuing State. Article 606 Content and form of the arrest warrant 1. The arrest warrant shall contain the following information set out in accordance with the form contained in Annex 43: (a) the identity and nationality of the requested person; (b) the name, address, telephone and fax numbers and e-mail address of the issuing judicial authority; (c) evidence of an enforceable judgment, an arrest warrant or any other enforceable judicial decision having the same effect that fall within the scope of Article 599; (d) the nature and legal classification of the offence, particularly in respect of Article 599; (e) a description of the circumstances in which the offence was committed, including the time, place and degree of participation in the offence by the requested person; (f) the penalty imposed, if there is a final judgment, or the prescribed scale of penalties for the offence under the law of the issuing State; and (g) if possible, other consequences of the offence. 2. The arrest warrant shall be translated into the official language or one of the official languages of the executing State. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that a translation in one or more other official languages of a State will be accepted. Article 607 Transmission of an arrest warrant If the location of the requested person is known, the issuing judicial authority may transmit the arrest warrant directly to the executing judicial authority. Article 608 Detailed procedures for transmitting an arrest warrant 1. If the issuing judicial authority does not know which authority is the competent executing judicial authority, it shall make the requisite enquiries, in order to obtain that information from the executing State. 2. The issuing judicial authority may request the International Criminal Police Organisation (\"Interpol\") to transmit an arrest warrant. 3. The issuing judicial authority may transmit the arrest warrant by any secure means capable of producing written records under conditions allowing the executing State to establish the authenticity of the arrest warrant. 4. All difficulties concerning the transmission or the authenticity of any document needed for the execution of the arrest warrant shall be dealt with by direct contacts between the judicial authorities involved, or, where appropriate, with the involvement of the central authorities of the States. 5. If the authority which receives an arrest warrant is not competent to act upon it, it shall automatically forward the arrest warrant to the competent authority in its State and shall inform the issuing judicial authority accordingly. Article 609 Rights of a requested person 1. If a requested person is arrested for the purpose of the execution of an arrest warrant, the executing judicial authority, in accordance with its domestic law, shall inform that person of the arrest warrant and of its contents, and also of the possibility of consenting to surrender to the issuing State. 2. A requested person who is arrested for the purpose of the execution of an arrest warrant and who does not speak or understand the language of the arrest warrant proceedings shall have the right to be assisted by an interpreter and to be provided with a written translation in the native language of the requested person or in any other language which that person speaks or understands, in accordance with the domestic law of the executing State. 3. A requested person shall have the right to be assisted by a lawyer in accordance with the domestic law of the executing State upon arrest. 4. The requested person shall be informed of the person's right to appoint a lawyer in the issuing State for the purpose of assisting the lawyer in the executing State in the arrest warrant proceedings. This paragraph is without prejudice to the time limits set out in Article 621. 5. A requested person who is arrested shall have the right to have the consular authorities of that person's State of nationality, or if that person is stateless, the consular authorities of the State where that person usually resides, informed of the arrest without undue delay and to communicate with those authorities, if that person so wishes. Article 610 Keeping the person in detention When a person is arrested on the basis of an arrest warrant, the executing judicial authority shall take a decision on whether the requested person should remain in detention, in accordance with the law of the executing State. The person may be released provisionally at any time in accordance with the domestic law of the executing State, provided that the competent authority of that State takes all the measures it deems necessary to prevent the person from absconding. Article 611 Consent to surrender 1. If the arrested person indicates that he or she consents to surrender, that consent and, if appropriate, the express renunciation of entitlement to the speciality rule referred to in Article 625(2) must be given before the executing judicial authority, in accordance with the domestic law of the executing State. 2. Each State shall adopt the measures necessary to ensure that the consent and, where appropriate, the renunciation referred to in paragraph 1 are established in such a way as to show that the person concerned has expressed them voluntarily and in full awareness of the consequences. To that end, the requested person shall have the right to a lawyer. 3. The consent and, where appropriate, the renunciation referred to in paragraph 1 shall be formally recorded in accordance with the procedure laid down by the domestic law of the executing State. 4. In principle, consent may not be revoked. Each State may provide that the consent and, if appropriate, the renunciation referred to in paragraph 1 of this Article may be revoked in accordance with the rules applicable under its domestic law. In such a case, the period between the date of the consent and that of its revocation shall not be taken into consideration in establishing the time limits laid down in Article 621. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that it wishes to have recourse to this possibility, specifying the procedures whereby revocation of the consent is possible and any amendments to those procedures. Article 612 Hearing of the requested person Where the arrested person does not consent to surrender as referred to in Article 611, that person shall be entitled to be heard by the executing judicial authority, in accordance with the law of the executing State. Article 613 Surrender decision 1. The executing judicial authority shall decide whether the person is to be surrendered within the time limits and in accordance with the conditions defined in this Title, in particular the principle of proportionality as set out in Article 597. 2. If the executing judicial authority finds the information communicated by the issuing State to be insufficient to allow it to decide on surrender, it shall request that the necessary supplementary information, in particular with respect to Article 597, Articles 600 to 602, Article 604 and Article 606, be furnished as a matter of urgency and may fix a time limit for the receipt thereof, taking into account the need to observe the time limits provided for in Article 615. 3. The issuing judicial authority may forward any additional useful information to the executing judicial authority at any time. Article 614 Decision in the event of multiple requests 1. If two or more States have issued a European arrest warrant or an arrest warrant for the same person, the decision as to which of those arrest warrants is to be executed shall be taken by the executing judicial authority, with due consideration of all the circumstances, especially the relative seriousness of the offences and place of the offences, the respective dates of the arrest warrants or European arrest warrants and whether they have been issued for the purposes of prosecution or for the execution of a custodial sentence or detention order, and of legal obligations of Member States deriving from Union law regarding, in particular, the principles of freedom of movement and non-discrimination on grounds of nationality. 2. The executing judicial authority of a Member State may seek the advice of Eurojust when making the choice referred to in paragraph 1. 3. In the event of a conflict between an arrest warrant and a request for extradition presented by a third country, the decision as to whether the arrest warrant or the extradition request takes precedence shall be taken by the competent authority of the executing State with due consideration of all the circumstances, in particular those referred to in paragraph 1 and those mentioned in the applicable convention. 4. This Article is without prejudice to the States' obligations under the Statute of the International Criminal Court. Article 615 Time limits and procedures for the decision to execute the arrest warrant 1. An arrest warrant shall be dealt with and executed as a matter of urgency. 2. In cases where the requested person consents to surrender, the final decision on the execution of the arrest warrant shall be taken within ten days after the consent was given. 3. In other cases, the final decision on the execution of the arrest warrant shall be taken within 60 days after the arrest of the requested person. 4. Where in specific cases the arrest warrant cannot be executed within the time limits laid down in paragraph 2 or 3, the executing judicial authority shall immediately inform the issuing judicial authority of that fact, giving the reasons for the delay. In such cases, the time limits may be extended by a further 30 days. 5. As long as the executing judicial authority has not taken a final decision on the arrest warrant, it shall ensure that the material conditions necessary for the effective surrender of the person remain fulfilled. 6. Reasons must be given for any refusal to execute an arrest warrant. Article 616 Situation pending the decision 1. Where the arrest warrant has been issued for the purpose of conducting a criminal prosecution, the executing judicial authority shall either: (a) agree that the requested person should be heard according to Article 617; or (b) agree to the temporary transfer of the requested person. 2. The conditions and the duration of the temporary transfer shall be determined by mutual agreement between the issuing and executing judicial authorities. 3. In the case of temporary transfer, the person must be able to return to the executing State to attend hearings which concern that person as part of the surrender procedure. Article 617 Hearing the person pending the decision 1. The requested person shall be heard by a judicial authority. To that end, the requested person shall be assisted by a lawyer designated in accordance with the law of the issuing State. 2. The requested person shall be heard in accordance with the law of the executing State and with the conditions determined by mutual agreement between the issuing and executing judicial authorities. 3. The competent executing judicial authority may assign another judicial authority of its State to take part in the hearing of the requested person in order to ensure the proper application of this Article. Article 618 Privileges and immunities 1. Where the requested person enjoys a privilege or immunity regarding jurisdiction or execution in the executing State, the time limits referred to in Article 615 only start running when, or if, the executing judicial authority is informed of the fact that the privilege or immunity has been waived. 2. The executing State shall ensure that the material conditions necessary for effective surrender are fulfilled when the person no longer enjoys such privilege or immunity. 3. Where power to waive the privilege or immunity lies with an authority of the executing State, the executing judicial authority shall request that authority to exercise that power without delay. Where power to waive the privilege or immunity lies with an authority of another State, third country or international organisation, the issuing judicial authority shall request that authority to exercise that power. Article 619 Competing international obligations 1. This Agreement does not prejudice the obligations of the executing State where the requested person has been extradited to that State from a third country and where that person is protected by provisions of the arrangement under which that person was extradited concerning the speciality rule. The executing State shall take all necessary measures for requesting without delay the consent of the third country from which the requested person was extradited so that the requested person can be surrendered to the State which issued the arrest warrant. The time limits referred to in Article 615 do not start running until the day on which the speciality rule ceases to apply. 2. Pending the decision of the third country from which the requested person was extradited, the executing State shall ensure that the material conditions necessary for effective surrender remain fulfilled. Article 620 Notification of the decision The executing judicial authority shall notify the issuing judicial authority immediately of the decision on the action to be taken on the arrest warrant. Article 621 Time limits for surrender of the person 1. The requested person shall be surrendered as soon as possible on a date agreed between the authorities concerned. 2. The requested person shall be surrendered no later than ten days after the final decision on the execution of the arrest warrant. 3. If the surrender of the requested person within the time limit in paragraph 2 is prevented by circumstances beyond the control of any of the States, the executing and issuing judicial authorities shall immediately contact each other and agree on a new surrender date. In that event, the surrender shall take place within ten days of the new date thus agreed. 4. The surrender may exceptionally be temporarily postponed for serious humanitarian reasons, for example if there are substantial grounds for believing that the surrender would manifestly endanger the requested person's life or health. The execution of the arrest warrant shall take place as soon as those grounds have ceased to exist. The executing judicial authority shall immediately inform the issuing judicial authority and agree on a new surrender date. In that event, the surrender shall take place within ten days of the new date agreed. 5. Upon the expiry of the time limits referred to in paragraphs 2 to 4, if the requested person is still being held in custody, that person shall be released. The executing and issuing judicial authorities shall contact each other as soon as it appears that a person is to be released under this paragraph and agree the arrangements for the surrender of that person. Article 622 Postponed or conditional surrender 1. After deciding to execute the arrest warrant, the executing judicial authority may postpone the surrender of the requested person so that the requested person may be prosecuted in the executing State or, if the requested person has already been sentenced, so that the requested person may serve, a sentence passed for an act other than that referred to in the arrest warrant in the territory of the executing State. 2. Instead of postponing the surrender, the executing judicial authority may temporarily surrender the requested person to the issuing State under conditions to be determined by mutual agreement between the executing and the issuing judicial authorities. The agreement shall be made in writing and the conditions shall be binding on all the authorities in the issuing State. Article 623 Transit 1. Each State shall permit the transit through its territory of a requested person who is being surrendered provided that it has been given information on: (a) the identity and nationality of the person subject to the arrest warrant; (b) the existence of an arrest warrant; (c) the nature and legal classification of the offence; and (d) the description of the circumstances of the offence, including the date and place. 2. The State, on behalf of which a notification has been made in accordance with Article 603(2) to the effect that its own nationals will not be surrendered or that surrender will be authorised only under certain specified conditions, may, refuse the transit of its own nationals through its territory under the same terms or submit it to the same conditions. 3. The States shall designate an authority responsible for receiving transit requests and the necessary documents, as well as any other official correspondence relating to transit requests. 4. The transit request and the information referred to in paragraph 1 may be addressed to the authority designated pursuant to paragraph 3 by any means capable of producing a written record. The State of transit shall notify its decision by the same procedure. 5. This Article does not apply in the case of transport by air without a scheduled stopover. However, if an unscheduled landing occurs, the issuing State shall provide the authority designated pursuant to paragraph 3 with the information referred to in paragraph 1. 6. Where a transit concerns a person who is to be extradited from a third country to a State, this Article applies mutatis mutandis. In particular, references to an \"arrest warrant\" shall be treated as references to an \"extradition request\". Article 624 Deduction of the period of detention served in the executing State 1. The issuing State shall deduct all periods of detention arising from the execution of an arrest warrant from the total period of detention to be served in the issuing State as a result of a custodial sentence or detention order being passed. 2. All information concerning the duration of the detention of the requested person on the basis of the arrest warrant shall be transmitted by the executing judicial authority or the central authority designated under Article 605 to the issuing judicial authority at the time of the surrender. Article 625 Possible prosecution for other offences 1. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that, in relations with other States to which the same notification applies, consent is presumed to have been given for the prosecution, sentencing or detention of a person with a view to the carrying out of a custodial sentence or detention order for an offence committed prior to the person's surrender, other than that for which that person was surrendered, unless in a particular case the executing judicial authority states otherwise in its decision on surrender. 2. Except in the cases referred to in paragraphs 1 and 3, a person surrendered may not be prosecuted, sentenced or otherwise deprived of liberty for an offence committed prior to that person's surrender other than that for which the person was surrendered. 3. Paragraph 2 of this Article does not apply in the following cases: (a) the person, having had an opportunity to leave the territory of the State to which that person has been surrendered, has not done so within 45 days of that person's final discharge or has returned to that territory after leaving it; (b) the offence is not punishable by a custodial sentence or detention order; (c) the criminal proceedings do not give rise to the application of a measure restricting personal liberty; (d) the person could be liable to a penalty or a measure not involving the deprivation of liberty, in particular a financial penalty or a measure in lieu of a financial penalty, even if the penalty or measure may give rise to a restriction of the person's personal liberty; (e) the person consented to be surrendered, where appropriate at the same time as the person renounced the speciality rule, in accordance with Article 611; (f) the person, after the person's surrender, has expressly renounced entitlement to the speciality rule with regard to specific offences preceding the person's surrender; renunciation must be given before the competent judicial authority of the issuing State and be recorded in accordance with that State's domestic law; the renunciation must be drawn up in such a way as to make clear that the person concerned has given it voluntarily and in full awareness of the consequences; to that end, the person shall have the right to a lawyer; and (g) the executing judicial authority which surrendered the person gives its consent in accordance with paragraph 4 of this Article. 4. A request for consent shall be submitted to the executing judicial authority, accompanied by the information referred to in Article 606(1) and a translation as referred to in Article 606(2). Consent shall be given where the offence for which it is requested is itself subject to surrender in accordance with the provisions of this Title. Consent shall be refused on the grounds referred to in Article 600 and otherwise may be refused only on the grounds referred to in Article 601, or Article 602(2) and Article 603(2). The decision shall be taken no later than 30 days after receipt of the request. For the situations laid down in Article 604 the issuing State must give the guarantees provided for therein. Article 626 Surrender or subsequent extradition 1. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that, in relations with other States to which the same notification applies, the consent for the surrender of a person to a State other than the executing State pursuant to an arrest warrant or European arrest warrant issued for an offence committed prior to that person's surrender is presumed to have been given, unless in a particular case the executing judicial authority states otherwise in its decision on surrender. 2. In any case, a person who has been surrendered to the issuing State pursuant to an arrest warrant or European arrest warrant may be surrendered to a State other than the executing State pursuant to an arrest warrant or European arrest warrant issued for any offence committed prior to the person's surrender without the consent of the executing State in the following cases: (a) the requested person, having had an opportunity to leave the territory of the State to which that person has been surrendered, has not done so within 45 days of that person's final discharge, or has returned to that territory after leaving it; (b) the requested person consents to be surrendered to a State other than the executing State pursuant to an arrest warrant or European arrest warrant; consent must be given before the competent judicial authorities of the issuing State and be recorded in accordance with that State's domestic law; it must be drawn up in such a way as to make clear that the person concerned has given it voluntarily and in full awareness of the consequences; to that end, the requested person shall have the right to a lawyer; and (c) the requested person is not subject to the speciality rule, in accordance with point (a), (e), (f) or (g) of Article 625(3). 3. The executing judicial authority shall consent to the surrender to another State in accordance with the following rules: (a) the request for consent shall be submitted in accordance with Article 607, accompanied by the information set out in Article 606(1) and a translation as referred to in Article 606(2); (b) consent shall be given where the offence for which it is requested is itself subject to surrender in accordance with the provisions of this Agreement; (c) the decision shall be taken no later than 30 days after receipt of the request; and (d) consent shall be refused on the grounds referred to in Article 600 and otherwise may be refused only on the grounds referred to in Article 601, Article 602(2) and Article 603(2). 4. For the situations referred to in Article 604, the issuing State shall give the guarantees provided for therein. 5. Notwithstanding paragraph 1, a person who has been surrendered pursuant to an arrest warrant shall not be extradited to a third country without the consent of the competent authority of the State which surrendered the person. Such consent shall be given in accordance with the Conventions by which that State is bound, as well as with its domestic law. Article 627 Handing over of property 1. At the request of the issuing judicial authority or on its own initiative, the executing judicial authority shall, in accordance with its domestic law, seize and hand over property which: (a) may be required as evidence; or (b) has been acquired by the requested person as a result of the offence. 2. The property referred to in paragraph 1 shall be handed over even if the arrest warrant cannot be carried out owing to the death or escape of the requested person. 3. If the property referred to in paragraph 1 is liable to seizure or confiscation in the territory of the executing State, that State may, if the property is needed in connection with pending criminal proceedings, temporarily retain it or hand it over to the issuing State on condition that it is returned. 4. Any rights which the executing State or third parties may have acquired in the property referred to in paragraph 1 shall be preserved. Where such rights exist, the issuing State shall return the property without charge to the executing State as soon as the criminal proceedings have been terminated. Article 628 Expenses 1. Expenses incurred in the territory of the executing State for the execution of an arrest warrant shall be borne by that State. 2. All other expenses shall be borne by the issuing State. Article 629 Relation to other legal instruments 1. Without prejudice to their application in relations between States and third countries, this Title, from the date of entry into force of this Agreement, replaces the corresponding provisions of the following conventions applicable in the field of extradition in relations between the United Kingdom, on the one side, and Member States, on the other side: (a) the European Convention on Extradition, done at Paris on 13 December 1957, and its additional protocols; and (b) the European Convention on the Suppression of Terrorism, as far as extradition is concerned. 2. Where the Conventions referred to in paragraph 1 apply to the territories of States or to territories for whose external relations a State is responsible to which this Title does not apply, those Conventions continue to govern the relations existing between those territories and the other States. Article 630 Review of notifications When carrying out the joint review of this Title as referred to in Article 691(1), the Parties shall consider the need to maintain the notifications made under Article 599(4), Article 602(2) and Article 603(2). If the notifications referred to in Article 603(2) are not renewed, they shall expire five years after the date of entry into force of this Agreement. Notifications as referred to in Article 603(2) may only be renewed or newly made during the three months prior to the fifth anniversary of the entry into force of this Agreement and, subsequently, every five years thereafter, provided that the conditions set out in Article 603(2) are met at that time. Article 631 Ongoing arrest warrants in case of disapplication Notwithstanding Article 526, Article 692 and Article 693, the provisions of this Title apply in respect of arrest warrants where the requested person was arrested before the disapplication of this Title for the purposes of the execution of an arrest warrant, irrespective of the decision of the executing judicial authority as to whether the requested person is to remain in detention or be provisionally released. Article 632 Application to existing European arrest warrants This Title shall apply in respect of European arrest warrants issued in accordance with Council Framework Decision 2002/584/JHA (81) by a State before the end of the transition period where the requested person has not been arrested for the purpose of its execution before the end of the transition period. TITLE VIII MUTUAL ASSISTANCE Article 633 Objective 1. The objective of this Title is to supplement the provisions, and facilitate the application between Member States, on the one side, and the United Kingdom, on the other side, of: (a) the European Convention on Mutual Assistance in Criminal Matters, done at Strasbourg on 20 April 1959 (the \"European Mutual Assistance Convention\"); (b) the Additional Protocol to the European Mutual Assistance Convention, done at Strasbourg on 17 March 1978; and (c) the Second Additional Protocol to the European Mutual Assistance Convention, done at Strasbourg on 8 November 2001. 2. This Title is without prejudice to the provisions of Title IX, which takes precedence over this Title. Article 634 Definition of competent authority For the purposes of this Title, \"competent authority\" means any authority which is competent to send or receive requests for mutual assistance in accordance with the provisions of the European Mutual Assistance Convention and its Protocols and as defined by States in their respective declarations addressed to the Secretary General of the Council of Europe. \"Competent authority\" also includes Union bodies notified in accordance with point (d) of Article 690; with regard to such Union bodies, the provisions of this Title apply accordingly. Article 635 Form for a request for mutual assistance 1. The Specialised Committee on Law Enforcement and Judicial Cooperation shall undertake to establish a standard form for requests for mutual assistance by adopting an annex to this Agreement. 2. If the Specialised Committee on Law Enforcement and Judicial Cooperation has adopted a decision in accordance with paragraph 1, requests for mutual assistance shall be made using the standard form. 3. The Specialised Committee on Law Enforcement and Judicial Cooperation may amend the standard form for requests for mutual assistance as may be necessary. Article 636 Conditions for a request for mutual assistance 1. The competent authority of the requesting State may only make a request for mutual assistance if it is satisfied that the following conditions are met: (a) the request is necessary and proportionate for the purpose of the proceedings, taking into account the rights of the suspected or accused person; and (b) the investigative measure or investigative measures indicated in the request could have been ordered under the same conditions in a similar domestic case. 2. The requested State may consult the requesting State if the competent authority of the requested State is of the view that the conditions in paragraph 1 are not met. After the consultation, the competent authority of the requesting State may decide to withdraw the request for mutual assistance. Article 637 Recourse to a different type of investigative measure 1. Wherever possible, the competent authority of the requested State shall consider recourse to an investigative measure other than the measure indicated in the request for mutual assistance if: (a) the investigative measure indicated in the request does not exist under the law of the requested State; or (b) the investigative measure indicated in the request would not be available in a similar domestic case. 2. Without prejudice to the grounds for refusal available under the European Mutual Assistance Convention and its Protocols and under Article 639, paragraph 1 of this Article does not apply to the following investigative measures, which shall always be available under the law of the requested State: (a) the obtaining of information contained in databases held by police or judicial authorities that is directly accessible by the competent authority of the requested State in the framework of criminal proceedings; (b) the hearing of a witness, expert, victim, suspected or accused person or third party in the territory of the requested State; (c) any non-coercive investigative measure as defined under the law of the requested State; and (d) the identification of persons holding a subscription to a specified phone number or IP address. 3. The competent authority of the requested State may also have recourse to an investigative measure other than the measure indicated in the request for mutual assistance if the investigative measure selected by the competent authority of the requested State would achieve the same result by less intrusive means than the investigative measure indicated in the request. 4. If the competent authority of the requested State decides to have recourse to a measure other than that indicated in the request for mutual assistance as referred to in paragraph 1 or 3, it shall first inform the competent authority of the requesting State, which may decide to withdraw or supplement the request. 5. If the investigative measure indicated in the request does not exist under the law of the requested State or would not be available in a similar domestic case, and there is no other investigative measure which would have the same result as the investigative measure requested, the competent authority of the requested State shall inform the competent authority of the requesting State that it is not possible to provide the assistance requested. Article 638 Obligation to inform The competent authority of the requested State shall inform the competent authority of the requesting State by any means and without undue delay if: (a) it is impossible to execute the request for mutual assistance due to the fact that the request is incomplete or manifestly incorrect; or (b) the competent authority of the requested State, in the course of the execution of the request for mutual assistance, considers without further enquiries that it may be appropriate to carry out investigative measures not initially foreseen, or which could not be specified when the request for mutual assistance was made, in order to enable the competent authority of the requesting State to take further action in the specific case. Article 639 Ne bis in idem Mutual assistance may be refused, in addition to the grounds for refusal provided for under the European Mutual Assistance Convention and its Protocols, on the ground that the person in respect of whom the assistance is requested and who is subject to criminal investigations, prosecutions or other proceedings, including judicial proceedings, in the requesting State, has been finally judged by another State in respect of the same acts, provided that, if a penalty has been imposed, it has been enforced, is in the process of being enforced or can no longer be enforced under the law of the sentencing State. Article 640 Time limits 1. The requested State shall decide whether to execute the request for mutual assistance as soon as possible and in any event no later than 45 days after the receipt of the request and shall inform the requesting State of its decision. 2. A request for mutual assistance shall be executed as soon as possible and in any event no later than 90 days after the decision referred to in paragraph 1 of this Article or after the consultation referred to in Article 636(2) has taken place. 3. If it is indicated in the request for mutual assistance that, due to procedural deadlines, the seriousness of the offence or other particularly urgent circumstances, a shorter time limit than that provided for in paragraph 1 or 2 is necessary, or if it is indicated in the request that a measure for mutual assistance is to be carried out on a specific date, the requested State shall take as full account as possible of that requirement. 4. If a request for mutual assistance is made to take provisional measures pursuant to Article 24 of the Second Additional Protocol to the European Mutual Assistance Convention, the competent authority of the requested State shall decide on the provisional measure, and shall communicate that decision to the competent authority of the requesting State, as soon as possible after the receipt of the request. Before lifting any provisional measure taken pursuant to this Article, the competent authority of the requested State, wherever possible, shall give the competent authority of the requesting State an opportunity to present its reasons in favour of continuing the measure. 5. If in a specific case, the time limit provided for in paragraph 1 or 2, or the time limit or specific date referred to in paragraph 3 cannot be met, or the decision on taking provisional measures in accordance with paragraph 4 is delayed, the competent authority of the requested State shall, without delay, inform the competent authority of the requesting State by any means, giving the reasons for the delay, and shall consult with the competent authority of the requesting State on the appropriate timing to execute the request for mutual assistance. 6. The time limits referred to in this Article do not apply if the request for mutual assistance is made in relation to any of the following offences and infringements that fall within scope of the European Mutual Assistance Convention and its Protocols, as defined in the law of the requesting State: (a) speeding, if no injury or death was caused to another person and if the excess speed was not significant; (b) failure to wear a seatbelt; (c) failure to stop at a red light or other mandatory stop signal; (d) failure to wear a safety helmet; or (e) using a forbidden lane (such as the forbidden use of an emergency lane, a lane reserved for public transport, or a lane closed down for road works). 7. The Specialised Committee on Law Enforcement and Judicial Cooperation shall keep the operation of paragraph 6 under review. It shall undertake to set time limits for the requests to which paragraph 6 applies within three years of the entry into force of this Agreement, taking into account the volume of requests. It may also decide that paragraph 6 shall no longer apply. Article 641 Transmission of requests for mutual assistance 1. In addition to the channels of communication provided for under the European Mutual Assistance Convention and its Protocols, if direct transmission is provided for under their respective provisions, requests for mutual assistance may also be transmitted directly by public prosecutors in the United Kingdom to competent authorities of the Member States. 2. In addition to the channels of communication provided for under the European Mutual Assistance Convention and its Protocols, in urgent cases, any request for mutual assistance, as well as spontaneous information, may be transmitted via Europol or Eurojust, in line with the provisions in the respective Titles of this Agreement. Article 642 Joint Investigation Teams If the competent authorities of States set up a Joint Investigation Team, the relationship between Member States within the Joint Investigation Team shall be governed by Union law, notwithstanding the legal basis referred to in the Agreement on the setting up of the Joint Investigation Team. TITLE IX EXCHANGE OF CRIMINAL RECORD INFORMATION Article 643 Objective 1. The objective of this Title is to enable the exchange between the Members States, on the one side, and the United Kingdom, on the other side, of information extracted from the criminal record. 2. In the relations between the United Kingdom and the Member States, the provisions of this Title: (a) supplement Articles 13 and 22(2) of the European Convention on Mutual Assistance in Criminal Matters and its Additional Protocols of 17 March 1978 and 8 November 2001; and (b) replace Article 22(1) of the European Convention on Mutual Assistance in Criminal Matters, as supplemented by Article 4 of its Additional Protocol of 17 March 1978. 3. In the relations between a Member State, on the one side, and the United Kingdom, on the other side, each shall waive the right to rely on its reservations to Article 13 of the European Convention on Mutual Assistance in Criminal Matters and to Article 4 of its Additional Protocol of 17 March 1978. Article 644 Definitions For the purposes of this Title, the following definitions apply: (a) \"conviction\" means any final decision of a criminal court against a natural person in respect of a criminal offence, to the extent that the decision is entered in the criminal record of the convicting State; (b) \"criminal proceedings\" means the pre-trial stage, the trial stage and the execution of a conviction; (c) \"criminal record\" means the domestic register or registers recording convictions in accordance with domestic law. Article 645 Central authorities Each State shall designate one or more central authorities that shall be competent for the exchange of information extracted from the criminal record pursuant to this Title and for the exchanges referred to in Article 22(2) of the European Convention on Mutual Assistance in Criminal Matters. Article 646 Notifications 1. Each State shall take the necessary measures to ensure that all convictions handed down within its territory are accompanied, when provided to its criminal record, by information on the nationality or nationalities of the convicted person if that person is a national of another State. 2. The central authority of each State shall inform the central authority of any other State of all criminal convictions handed down within its territory in respect of nationals of the latter State, as well as of any subsequent alterations or deletions of information contained in the criminal record, as entered in the criminal record. The central authorities of the States shall communicate such information to each other at least once per month. 3. If the central authority of a State becomes aware of the fact that a convicted person is a national of two or more other States, it shall transmit the relevant information to each of those States, even if the convicted person is a national of the State within whose territory that person was convicted. Article 647 Storage of convictions 1. The central authority of each State shall store all information notified under Article 646. 2. The central authority of each State shall ensure that if a subsequent alteration or deletion is notified under Article 646(2), an identical alteration or deletion is made to the information stored in accordance with paragraph 1 of this Article. 3. The central authority of each State shall ensure that only information which has been updated in accordance with paragraph 2 of this Article is provided when replying to requests made under Article 648. Article 648 Requests for information 1. If information from the criminal record of a State is requested at domestic level for the purposes of criminal proceedings against a person or for any purposes other than that of criminal proceedings, the central authority of that State may, in accordance with its domestic law, submit a request to the central authority of another State for information and related data to be extracted from the criminal record. 2. If a person asks the central authority of a State other than the State of the person's nationality for information on the person's own criminal record, that central authority shall submit a request to the central authority of the State of the person's nationality for information and related data to be extracted from the criminal record in order to be able to include that information and related data in the extract to be provided to the person concerned. Article 649 Replies to requests 1. Replies to requests for information shall be transmitted by the central authority of the requested State to the central authority of the requesting State as soon as possible and in any event within 20 working days from the date the request was received. 2. The central authority of each State shall reply to requests made for purposes other than that of criminal proceedings in accordance with its domestic law. 3. Notwithstanding paragraph 2, when replying to requests made for the purposes of recruitment for professional or organised voluntary activities involving direct and regular contacts with children, the States shall include information on the existence of criminal convictions for offences related to sexual abuse or sexual exploitation of children, child pornography, solicitation of children for sexual purposes, including inciting, aiding and abetting or attempting to commit any of those offences, as well as information on the existence of any disqualification from exercising activities involving direct and regular contacts with children arising from those criminal convictions. Article 650 Channel of communication The exchange between States of information extracted from the criminal record shall take place electronically in accordance with the technical and procedural specifications laid down in Annex 44. Article 651 Conditions for the use of personal data 1. Each State may use personal data received in reply to its request under Article 649 only for the purposes for which they were requested. 2. If the information was requested for any purposes other than that of criminal proceedings, personal data received under Article 649 may be used by the requesting State in accordance with its domestic law only within the limits specified by the requested State in the form set out in Chapter 2 of Annex 44. 3. Notwithstanding paragraphs 1 and 2 of this Article, personal data provided by a State in reply to a request under Article 649 may be used by the requesting State to prevent an immediate and serious threat to public security. 4. Each State shall ensure that their central authorities do not disclose personal data notified under Article 646 to authorities in third countries unless the following conditions are met: (a) the personal data are disclosed only on a case-by-case basis; (b) the personal data are disclosed to authorities whose functions are directly related to the purposes for which the personal data are disclosed under point (c) of this paragraph; (c) the personal data are disclosed only if necessary: (i) for the purposes of criminal proceedings; (ii) for any purposes other than that of criminal proceedings; or (iii) to prevent an immediate and serious threat to public security; (d) the personal data may be used by the requesting third country only for the purposes for which the information was requested and within the limits specified by the State that notified the personal data under Article 646; and (e) the personal data are disclosed only if the central authority, having assessed all the circumstances surrounding the transfer of the personal data to the third country, concludes that appropriate safeguards exist to protect the personal data. 2. This Article does not apply to personal data obtained by a State under this Title and originating from that State. TITLE X ANTI-MONEY LAUNDERING AND COUNTER TERRORIST FINANCING Article 652 Objective The objective of this Title is to support and strengthen action by the Union and the United Kingdom to prevent and combat money laundering and terrorist financing. Article 653 Measures to prevent and combat money laundering and terrorist financing 1. The Parties agree to support international efforts to prevent and combat money laundering and terrorist financing. The Parties recognise the need to cooperate in preventing the use of their financial systems to launder the proceeds of all criminal activity, including drug trafficking and corruption, and to combat terrorist financing. 2. The Parties shall exchange relevant information, as appropriate within their respective legal frameworks. 3. The Parties shall each maintain a comprehensive regime to combat money laundering and terrorist financing, and regularly review the need to enhance that regime, taking account of the principles and objectives of the Financial Action Task Force Recommendations. Article 654 Beneficial ownership transparency for corporate and other legal entities 1. For the purposes of this Article, the following definitions apply: (a) \"beneficial owner\" means any individual in respect of a corporate entity who, in accordance with the Party's laws and regulations: (i) exercises or has the right to exercise ultimate control over the management of the entity; (ii) ultimately owns or controls directly or indirectly more than 25 % of the voting rights or shares or other ownership interests in the entity, without prejudice to each Party's right to define a lower percentage; or (iii) otherwise controls or has the right to control the entity; In respect of legal entities such as foundations, Anstalt and limited liability partnerships, each Party has the right to determine similar criteria for identifying the beneficial owner, or, if they choose, to apply the definition set out in point (a) of Article 655(1), having regard to the form and structure of such entities. In respect of other legal entities not mentioned above, each Party shall take into account the different forms and structures of such entities and the levels of money laundering and terrorist financing risks associated with such entities, with a view to deciding the appropriate levels of beneficial ownership transparency; (b) \"basic information about a beneficial owner\" means the beneficial owner's name, month and year of birth, country of residence and nationality, as well as the nature and extent of the interest held, or control exercised, over the entity by the beneficial owner; (c) \"competent authorities\" means: (i) public authorities, including Financial Intelligence Units, that have designated responsibilities for combating money laundering or terrorist financing; (ii) public authorities that have the function of investigating or prosecuting money laundering, associated predicate offences or terrorist financing, or that have the function of tracing, seizing or freezing and confiscating criminal assets; (iii) public authorities that have supervisory or monitoring responsibilities aimed at ensuring compliance with anti-money laundering or counter terrorist financing requirements. This definition is without prejudice to each Party's right to identify additional competent authorities that can access information about beneficial owners. 2. Each Party shall ensure that legal entities in its territory maintain adequate, accurate and up-to-date information about beneficial owners. Each Party shall put in place mechanisms to ensure that their competent authorities have timely access to such information. 3. Each Party shall establish or maintain a central register holding adequate, up-to-date and accurate information about beneficial owners. In the case of the Union, the central registers shall be set up at the level of the Member States. This obligation shall not apply in respect of legal entities listed on a stock exchange that are subject to disclosure requirements regarding an adequate level of transparency. Where no beneficial owner is identified in respect of an entity, the register shall hold alternative information, such as a statement that no beneficial owner has been identified or details of the natural person or persons who hold the position of senior managing official in the legal entity. 4. Each Party shall ensure that the information held in its central register or registers is made available to its competent authorities without restriction and in a timely manner. 5. Each Party shall ensure that basic information about beneficial owners is made available to any member of the public. Limited exceptions may be made to the public availability of information under this paragraph in cases where public access would expose the beneficial owner to disproportionate risks, such as risks of fraud, kidnapping, blackmail, extortion, harassment, violence or intimidation, or where the beneficial owner is a minor or otherwise legally incapable. 6. Each Party shall ensure that there are effective, proportionate and dissuasive sanctions against legal or natural persons who fail to comply with requirements imposed on them in connection with the matters referred to in this Article. 7. Each Party shall ensure that its competent authorities are able to provide the information referred to in paragraphs 2 and 3 to the competent authorities of the other Party in a timely and effective manner and free of charge. To that end, the Parties shall consider ways to ensure the secure exchange of information. Article 655 Beneficial ownership transparency of legal arrangements 1. For the purposes of this Article, the following definitions apply: (a) \"beneficial owner\" means the settlor, the protector (if any), trustees, the beneficiary or class of beneficiaries, any person holding an equivalent position in relation to a legal arrangement with a structure or function similar to an express trust, and any other natural person exercising ultimate effective control over a trust or a similar legal arrangement; (b) \"competent authorities\" means: (i) public authorities, including Financial Intelligence Units, that have designated responsibilities for combating money laundering or terrorist financing; (ii) public authorities that have the function of investigating or prosecuting money laundering, associated predicate offences or terrorist financing or the function of tracing, seizing or freezing and confiscating criminal assets; (iii) public authorities that have supervisory or monitoring responsibilities aimed at ensuring compliance with anti-money laundering or counter terrorist financing requirements. This definition is without prejudice to each Party's right to identify additional competent authorities that can access information about beneficial owners. 2. Each Party shall ensure that trustees of express trusts maintain adequate, accurate and up-to-date information about beneficial owners. These measures shall also apply to other legal arrangements identified by each Party as having a structure or function similar to trusts. 3. Each Party shall put in place mechanisms to ensure that its competent authorities have timely access to adequate, accurate and up-to-date information about beneficial owners of express trusts and other legal arrangements with a structure or function similar to trusts in its territory. 4. If the beneficial ownership information about trusts or similar legal arrangements is held in a central register, the State concerned shall ensure that the information is adequate, accurate and up-to-date, and that competent authorities have timely and unrestricted access to such information. The Parties shall endeavour to consider ways to provide access to beneficial ownership information about trusts and similar legal arrangements to individuals or organisations who can demonstrate a legitimate interest in seeing such information. 5. Each Party shall ensure that there are effective, proportionate and dissuasive sanctions against legal or natural persons who fail to comply with requirements imposed on them in connection with the matters referred to in this Article. 6. Each Party shall ensure that its competent authorities are able to provide the information referred to in paragraph 3 to the competent authorities of the other Party in a timely and effective manner and free of charge. To that end, the Parties shall consider ways to ensure the secure exchange of information. TITLE XI FREEZING AND CONFISCATION Article 656 Objective and principles of cooperation 1. The objective of this Title is to provide for cooperation between the United Kingdom, on the one side, and the Member States, on the other side, to the widest extent possible for the purposes of investigations and proceedings aimed at the freezing of property with a view to subsequent confiscation thereof and investigations and proceedings aimed at the confiscation of property within the framework of proceedings in criminal matters. This does not preclude other cooperation pursuant to Article 665(5) and (6). This Title also provides for cooperation with Union bodies designated by the Union for the purposes of this Title. 2. Each State shall comply, under the conditions provided for in this Title, with requests from another State: (a) for the confiscation of specific items of property, as well as for the confiscation of proceeds consisting in a requirement to pay a sum of money corresponding to the value of proceeds; (b) for investigative assistance and provisional measures with a view to either form of confiscation referred to in point (a). 3. Investigative assistance and provisional measures sought under point (b) of paragraph 2 shall be carried out as permitted by and in accordance with the domestic law of the requested State. Where the request concerning one of these measures specifies formalities or procedures which are necessary under the domestic law of the requesting State, even if unfamiliar to the requested State, the latter shall comply with such requests to the extent that the action sought is not contrary to the fundamental principles of its domestic law. 4. The requested State shall ensure that the requests coming from another State to identify, trace, freeze or seize the proceeds and instrumentalities, receive the same priority as those made in the framework of domestic procedures. 5. When requesting confiscation, investigative assistance and provisional measures for the purposes of confiscation, the requesting State shall ensure that the principles of necessity and proportionality are respected. 6. The provisions of this Title apply in place of the \"international cooperation\" Chapters of the Council of Europe Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and on the Financing of Terrorism, done at Warsaw on 16 May 2005 (the \"2005 Convention\") and the Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime, done at Strasbourg on 8 November 1990 (the \"1990 Convention\"). Article 657 of this Agreement replaces the corresponding definitions in Article 1 of the 2005 Convention and Article 1 of the 1990 Convention. The provisions of this Title do not affect the States' obligations under the other provisions of the 2005 Convention and the 1990 Convention. Article 657 Definitions For the purposes of this Title, the following definitions apply: (a) \"confiscation\" means a penalty or a measure ordered by a court following proceedings in relation to a criminal offence or criminal offences, resulting in the final deprivation of property; (b) \"freezing\" or \"seizure\" means temporarily prohibiting the transfer, destruction, conversion, disposition or movement of property or temporarily assuming custody or control of property on the basis of an order issued by a court or other competent authority; (c) \"instrumentalities\" means any property used or intended to be used, in any manner, wholly or in part, to commit a criminal offence or criminal offences; (d) \"judicial authority\" means an authority that is, under domestic law, a judge, a court or a public prosecutor; a public prosecutor is considered a judicial authority only to the extent that domestic law so provides; (e) \"proceeds\" means any economic benefit, derived from or obtained, directly or indirectly, from criminal offences, or an amount of money equivalent to that economic benefit; it may consist of any property as defined in this Article; (f) \"property\" includes property of any description, whether corporeal or incorporeal, movable or immovable, and legal documents or instruments evidencing title or interest in such property, which the requesting State considers to be: (i) the proceeds of a criminal offence, or its equivalent, whether the full amount of the value of such proceeds or only part of the value of such proceeds; (ii) the instrumentalities of a criminal offence, or the value of such instrumentalities; (iii) subject to confiscation under any other provisions relating to powers of confiscation under the law of the requesting State, following proceedings in relation to a criminal offence, including third party confiscation, extended confiscation and confiscation without final conviction. Article 658 Obligation to assist The States shall afford each other, upon request, the widest possible measure of assistance in the identification and tracing of instrumentalities, proceeds and other property liable to confiscation. Such assistance shall include any measure providing and securing evidence as to the existence, location or movement, nature, legal status or value of those instrumentalities, proceeds or other property. Article 659 Requests for information on bank accounts and safe deposit boxes 1. The requested State shall, under the conditions set out in this Article, take the measures necessary to determine, in answer to a request sent by another State, whether a natural or legal person that is the subject of a criminal investigation holds or controls one or more accounts, of whatever nature, in any bank located in its territory and, if so, provide the details of the identified accounts. These details shall in particular include the name of the customer account holder and the IBAN number, and, in the case of safe deposit boxes, the name of the lessee or a unique identification number. 2. The obligation set out in paragraph 1 applies only to the extent that the information is in the possession of the bank keeping the account. 3. In addition to the requirements of Article 680, the requesting State shall, in the request: (a) indicate why it considers that the requested information is likely to be of substantial value for the purposes of the criminal investigation into the offence; (b) state on what grounds it presumes that banks in the requested State hold the account and specify, to the widest extent possible, which banks and accounts may be involved; and (c) include any additional information available which may facilitate the execution of the request. 4. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that this Article will be extended to accounts held in non-bank financial institutions. Such notifications may be made subject to the principle of reciprocity. Article 660 Requests for information on banking transactions 1. On request by another State, the requested State shall provide the particulars of specified bank accounts and of banking operations which have been carried out during a specified period through one or more accounts specified in the request, including the particulars of any sending or recipient account. 2. The obligation set out in paragraph 1 applies only to the extent that the information is in the possession of the bank keeping the account. 3. In addition to the requirements of Article 680, the requesting State shall indicate in its request why it considers the requested information relevant for the purposes of the criminal investigation into the offence. 4. The requested State may make the execution of such a request dependent on the same conditions as it applies in respect of requests for search and seizure. 5. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that this Article will be extended to accounts held in non-bank financial institutions. Such notifications may be made subject to the principle of reciprocity. Article 661 Requests for the monitoring of banking transactions 1. The requested State shall ensure that, at the request of another State, it is able to monitor, during a specified period, the banking operations that are being carried out through one or more accounts specified in the request and to communicate the results of the monitoring to the requesting State. 2. In addition to the requirements of Article 680, the requesting State shall indicate in its request why it considers the requested information relevant for the purposes of the criminal investigation into the offence. 3. The decision to monitor shall be taken in each individual case by the competent authorities of the requested State, in accordance with its domestic law. 4. The practical details regarding the monitoring shall be agreed between the competent authorities of the requesting and requested States. 5. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that this Article will be extended to accounts held in non-bank financial institutions. Such notifications may be made subject to the principle of reciprocity. Article 662 Spontaneous information Without prejudice to its own investigations or proceedings, a State may without prior request forward to another State information on instrumentalities, proceeds and other property liable to confiscation, where it considers that the disclosure of such information might assist the receiving State in initiating or carrying out investigations or proceedings or might lead to a request by that State under this Title. Article 663 Obligation to take provisional measures 1. At the request of another State which has instituted a criminal investigation or proceedings, or an investigation or proceedings for the purposes of confiscation, the requested State shall take the necessary provisional measures, such as freezing or seizing, to prevent any dealing in, transfer or disposal of property which, at a later stage, may be the subject of a request for confiscation or which might satisfy the request. 2. A State which has received a request for confiscation pursuant to Article 665 shall, if so requested, take the measures referred to in paragraph 1 of this Article in respect of any property which is the subject of the request or which might satisfy the request. 3. Where a request is received under this Article, the requested State shall take all necessary measures to comply with the request without delay and with the same speed and priority as for a similar domestic case and send confirmation without delay and by any means of producing a written record to the requesting State. 4. Where the requesting State states that immediate freezing is necessary since there are legitimate grounds to believe that the property in question will immediately be removed or destroyed, the requested State shall take all necessary measures to comply with the request within 96 hours of receiving the request and send confirmation to the requesting State by any means of producing a written record and without delay. 5. Where the requested State is unable to comply with the time limits under paragraph 4, the requested State shall immediately inform the requesting State, and consult with the requesting State on the appropriate next steps. 6. Any expiration of the time limits under paragraph 4 does not extinguish the requirements placed on the requested State by this Article. Article 664 Execution of provisional measures 1. After the execution of the provisional measures requested in conformity with Article 663(1), the requesting State shall provide spontaneously and as soon as possible to the requested State all information which may question or modify the extent of those measures. The requesting State shall also provide without delay all complementary information required by the requested State and which is necessary for the implementation of and the follow-up to the provisional measures. 2. Before lifting any provisional measure taken pursuant to Article 663, the requested State shall, wherever possible, give the requesting State an opportunity to present its reasons in favour of continuing the measure. Article 665 Obligation to confiscate 1. The State which has received a request for confiscation of property situated in its territory shall: (a) enforce a confiscation order made by a court of the requesting State in relation to such property; or (b) submit the request to its competent authorities for the purpose of obtaining an order of confiscation and, if such an order is granted, enforce it. 2. For the purposes of point (b) of paragraph 1, the States shall, whenever necessary, have competence to institute confiscation proceedings under their own domestic law. 3. Paragraph 1 also applies to confiscation consisting in a requirement to pay a sum of money corresponding to the value of proceeds, if property against which the confiscation can be enforced is located in the requested State. In such cases, when enforcing confiscation pursuant to paragraph 1, the requested State shall, if payment is not obtained, realise the claim on any property available for that purpose. 4. If a request for confiscation concerns a specific item of property, the requesting State and requested State may agree that the requested State may enforce the confiscation in the form of a requirement to pay a sum of money corresponding to the value of the property. 5. A State shall cooperate to the widest extent possible under its domestic law with a State requesting the execution of measures equivalent to confiscation of property, where the request has not been issued in the framework of proceedings in criminal matters, in so far as such measures are ordered by a judicial authority of the requesting State in relation to a criminal offence, provided that it has been established that the property constitutes proceeds or: (a) other property into which the proceeds have been transformed or converted; (b) property acquired from legitimate sources, if proceeds have been intermingled, in whole or in part, with such property, up to the assessed value of the intermingled proceeds; or (c) income or other benefit derived from the proceeds, from property into which proceeds of crime have been transformed or converted or from property with which the proceeds of crime have been intermingled, up to the assessed value of the intermingled proceeds, in the same manner and to the same extent as proceeds. 6. The measures referred to in paragraph 5 include measures which allow the seizure, detention and forfeiture of property and assets by means of applications to civil courts. 7. The requested State shall take the decision on the execution of the confiscation order without delay, and, without prejudice to paragraph 8 of this Article, no later than 45 days after receiving the request. The requested State shall send confirmation to the requesting State by any means of producing a written record and without delay. Unless grounds for postponement under Article 672 exist, the requested State shall take the concrete measures necessary to execute the confiscation order without delay and, at least, with the same speed and priority as for a similar domestic case. 8. Where the requested State is unable to comply with the time limit under paragraph 7, the requested State shall immediately inform the requesting State, and consult with the requesting State on the appropriate next steps. 9. Any expiration of the time limit under paragraph 7 does not extinguish the requirements placed on the requested State by this Article. Article 666 Execution of confiscation 1. The procedures for obtaining and enforcing the confiscation under Article 665 shall be governed by the domestic law of the requested State. 2. The requested State shall be bound by the findings as to the facts in so far as they are stated in a conviction or judicial decision issued by a court of the requesting State or in so far as such conviction or judicial decision is implicitly based on them. 3. If the confiscation consists in the requirement to pay a sum of money, the competent authority of the requested State shall convert the amount thereof into the currency of that State at the rate of exchange applicable at the time when the decision to enforce the confiscation is taken. Article 667 Confiscated property 1. Subject to paragraphs 2 and 3 of this Article, property confiscated pursuant to Articles 665 and 666 shall be disposed of by the requested State in accordance with its domestic law and administrative procedures. 2. When acting on the request made by another State pursuant to Article 665, the requested State shall, to the extent permitted by its domestic law and if so requested, give priority consideration to returning the confiscated property to the requesting State so that it can give compensation to the victims of the crime or return such property to their legitimate owners. 3. Where acting on the request made by another State in accordance with Article 665, and after having taken into account the right of a victim to restitution or compensation of property pursuant to paragraph 2 of this Article, the requested State shall dispose of the money obtained as a result of the execution of a confiscation order as follows: (a) if the amount is equal to or less than EUR 10 000, the amount shall accrue to the requested State; or (b) if the amount is greater than EUR 10 000, the requested State shall transfer 50 % of the amount recovered to the requesting State. 4. Notwithstanding paragraph 3, the requesting State and requested State may, on a case-by-case basis, give special consideration to concluding other such agreements or arrangements on disposal of property as they deem appropriate. Article 668 Right of enforcement and maximum amount of confiscation 1. A request for confiscation made under Article 665 does not affect the right of the requesting State to enforce the confiscation order itself. 2. Nothing in this Title shall be interpreted as permitting the total value of the confiscation to exceed the amount of the sum of money specified in the confiscation order. If a State finds that this might occur, the States concerned shall enter into consultations to avoid such an effect. Article 669 Imprisonment in default The requested State shall not impose imprisonment in default or any other measure restricting the liberty of a person as a result of a request under Article 665 without the consent of the requesting State. Article 670 Grounds for refusal 1. Cooperation under this Title may be refused if: (a) the requested State considers that executing the request would be contrary to the principle of ne bis in idem; or (b) the offence to which the request relates does not constitute an offence under the domestic law of the requested State if committed within its jurisdiction; however, this ground for refusal applies to cooperation under Articles 658 to 662 only in so far as the assistance sought involves coercive action. 2. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that, on the basis of reciprocity, the condition of double criminality referred to in point (b) of paragraph 1 of this Article will not be applied provided that the offence giving rise to the request is: (a) one of the offences listed in Article 599(5), as defined by the law of the requesting State; and (b) punishable by the requesting State by a custodial sentence or a detention order for a maximum period of at least three years. 3. Cooperation under Articles 658 to 662, in so far as the assistance sought involves coercive action, and under Articles 663 and 664 may also be refused if the measures sought could not be taken under the domestic law of the requested State for the purposes of investigations or proceedings in a similar domestic case. 4. Where the domestic law of the requested State so requires, cooperation under Articles 658 to 662, in so far as the assistance sought involves coercive action, and under Articles 663 and 664 may also be refused if the measures sought or any other measures having similar effects would not be permitted under the domestic law of the requesting State, or, as regards the competent authorities of the requesting State, if the request is not authorised by a judicial authority acting in relation to criminal offences. 5. Cooperation under Articles 665 to 669 may also be refused if: (a) under the domestic law of the requested State, confiscation is not provided for in respect of the type of offence to which the request relates; (b) without prejudice to the obligation pursuant to Article 665(3), it would be contrary to the principles of the domestic law of the requested State concerning the limits of confiscation in respect of the relationship between an offence and: (i) an economic advantage that might be qualified as its proceeds; or (ii) property that might be qualified as its instrumentalities; (c) under the domestic law of the requested State, confiscation may no longer be imposed or enforced because of the lapse of time; (d) without prejudice to Article 665(5) and (6), the request does not relate to a previous conviction, or a decision of a judicial nature or a statement in such a decision that an offence or several offences have been committed, on the basis of which the confiscation has been ordered or is sought; (e) confiscation is either not enforceable in the requesting State, or it is still subject to ordinary means of appeal; or (f) the request relates to a confiscation order resulting from a decision rendered in absentia of the person against whom the order was issued and, in the opinion of the requested State, the proceedings conducted by the requesting State leading to such decision did not satisfy the minimum rights of defence recognised as due to everyone against whom a criminal charge is made. 6. For the purposes of point (f) of paragraph 5 a decision is not considered to have been rendered in absentia if: (a) it has been confirmed or pronounced after opposition by the person concerned; or (b) it has been rendered on appeal, provided that the appeal was lodged by the person concerned. 7. When considering, for the purposes of point (f) of paragraph 5, whether the minimum rights of defence have been satisfied, the requested State shall take into account the fact that the person concerned has deliberately sought to evade justice or the fact that that person, having had the possibility of lodging a legal remedy against the decision made in absentia, elected not to do so. The same applies where the person concerned, having been duly served with the summons to appear, elected not to do so nor to ask for adjournment. 8. The States shall not invoke bank secrecy as a ground to refuse any cooperation under this Title. Where its domestic law so requires, a requested State may require that a request for cooperation which would involve the lifting of bank secrecy be authorised by a judicial authority acting in relation to criminal offences. 9. The requested State shall not invoke the fact that: (a) the person under investigation or subject to a confiscation order by the authorities of the requesting State is a legal person as an obstacle to affording any cooperation under this Title; (b) the natural person against whom an order of confiscation of proceeds has been issued has died or a legal person against whom an order of confiscation of proceeds has been issued has subsequently been dissolved as an obstacle to affording assistance in accordance with point (a) of Article 665(1); or (c) the person under investigation or subject to a confiscation order by the authorities of the requesting State is mentioned in the request both as the author of the underlying criminal offence and of the offence of money laundering as an obstacle to affording any cooperation under this Title. Article 671 Consultation and information Where there are substantial grounds for believing that the execution of a freezing or confiscation order would entail a real risk for the protection of fundamental rights, the requested State shall, before it decides on the execution of the freezing or confiscation order, consult the requesting State and may require any necessary information to be provided. Article 672 Postponement The requested State may postpone action on a request if such action would prejudice investigations or proceedings by its authorities. Article 673 Partial or conditional granting of a request Before refusing or postponing cooperation under this Title, the requested State shall, where appropriate after having consulted the requesting State, consider whether the request may be granted partially or subject to such conditions as it deems necessary. Article 674 Notification of documents 1. The States shall afford each other the widest measure of mutual assistance in the serving of judicial documents to persons affected by provisional measures and confiscation. 2. Nothing in this Article is intended to interfere with: (a) the possibility of sending judicial documents, by postal channels, directly to persons abroad; and (b) the possibility for judicial officers, officials or other competent authorities of the State of origin to effect service of judicial documents directly through the consular authorities of that State or through the judicial authorities, including judicial officers and officials, or other competent authorities of the State of destination. 3. When serving judicial documents to persons abroad affected by provisional measures or confiscation orders issued in the sending State, that State shall indicate what legal remedies are available under its domestic law to such persons. Article 675 Recognition of foreign decisions 1. When dealing with a request for cooperation under Articles 663 to 669 the requested State shall recognise any decision issued by a judicial authority taken in the requesting State regarding rights claimed by third parties. 2. Recognition may be refused if: (a) third parties did not have adequate opportunity to assert their rights; (b) the decision is incompatible with a decision already taken in the requested State on the same matter; (c) it is incompatible with the ordre public of the requested State; or (d) the decision was taken contrary to provisions on exclusive jurisdiction provided for by the domestic law of the requested State. Article 676 Authorities 1. Each State shall designate a central authority to be responsible for sending and answering requests made under this Title, the execution of such requests or their transmission to the authorities competent for their execution. 2. The Union may designate a Union body which may, in addition to the competent authorities of the Member States, make and, if appropriate, execute requests under this Title. Any such request is to be treated for the purposes of this Title as a request by a Member State. The Union may also designate that Union body as the central authority responsible for the purpose of sending and answering requests made under this Title by, or to, that body. Article 677 Direct communication 1. The central authorities shall communicate directly with one another. 2. In urgent cases, requests or communications under this Title may be sent directly by the judicial authorities of the requesting State to judicial authorities of the requested State. In such cases, a copy shall be sent at the same time to the central authority of the requested State through the central authority of the requesting State. 3. Where a request is made pursuant to paragraph 2 and the authority is not competent to deal with the request, it shall refer the request to the competent national authority and shall directly inform the requesting State that it has done so. 4. Requests or communications under Articles 658 to 662, which do not involve coercive action, may be directly transmitted by the competent authorities of the requesting State to the competent authorities of the requested State. 5. Draft requests or communications under this Title may be sent directly by the judicial authorities of the requesting State to the judicial authorities of the requested State prior to a formal request to ensure that the formal request can be dealt with efficiently upon receipt and that it contains sufficient information and supporting documentation for it to meet the requirements of the law of the requested State. Article 678 Form of request and languages 1. All requests under this Title shall be made in writing. They may be transmitted electronically, or by any other means of telecommunication, provided that the requesting State is prepared, upon request, to produce a written record of such communication and the original at any time. 2. Requests under paragraph 1 shall be made in one of the official languages of the requested State or in any other language notified by or on behalf of the requested State in accordance with paragraph 3. 3. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation of the language or languages which, in addition to the official language or languages of that State, may be used for making requests under this Title. 4. Requests under Article 663 for provisional measures shall be made using the prescribed form at Annex 46. 5. Requests under Article 665 for confiscation shall be made using the prescribed form at Annex 46. 6. The Specialised Committee on Law Enforcement and Judicial Cooperation may amend the forms referred to in paragraphs 4 and 5 as may be necessary. 7. The United Kingdom and the Union, acting on behalf of any of its Member States may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that it requires the translation of any supporting documents into one of the official languages of the requested State or any other language indicated in accordance with paragraph 3 of this Article. In the case of requests pursuant to Article 663(4), such translation of supporting documents may be provided to the requested State within 48 hours after transmitting the request, without prejudice to the time limits provided for in Article 663(4). Article 679 Legalisation Documents transmitted in application of this Title shall be exempt from all legalisation formalities. Article 680 Content of request 1. Any request for cooperation under this Title shall specify: (a) the authority making the request and the authority carrying out the investigations or proceedings; (b) the object of and the reason for the request; (c) the matters, including the relevant facts (such as date, place and circumstances of the offence) to which the investigations or proceedings relate, except in the case of a request for notification; (d) insofar as the cooperation involves coercive action: (i) the text of the statutory provisions or, where that is not possible, a statement of the relevant applicable law; and (ii) an indication that the measure sought or any other measures having similar effects could be taken in the territory of the requesting State under its own domestic law; (e) where necessary and in so far as possible: (i) details of the person or persons concerned, including name, date and place of birth, nationality and location, and, in the case of a legal person, its seat; and (ii) the property in relation to which cooperation is sought, its location, its connection with the person or persons concerned, any connection with the offence, as well as any available information about other persons, interests in the property; and (f) any particular procedure the requesting State wishes to be followed. 2. A request for provisional measures under Article 663 in relation to seizure of property on which a confiscation order consisting of the requirement to pay a sum of money may be realised shall also indicate a maximum amount for which recovery is sought in that property. 3. In addition to the information referred to in paragraph 1 of this Article, any request under Article 665 shall contain: (a) in the case of point (a) of Article 665(1): (i) a certified true copy of the confiscation order made by the court in the requesting State and a statement of the grounds on the basis of which the order was made, if they are not indicated in the order itself; (ii) an attestation by the competent authority of the requesting State that the confiscation order is enforceable and not subject to ordinary means of appeal; (iii) information as to the extent to which the enforcement of the order is requested; and (iv) information as to the necessity of taking any provisional measures; (b) in the case of point (b) of Article 665(1), a statement of the facts relied upon by the requesting State sufficient to enable the requested State to seek the order under its domestic law; (c) where third parties have had the opportunity to claim rights, documents demonstrating that this has been the case. Article 681 Defective requests 1. If a request does not comply with the provisions of this Title or the information supplied is not sufficient to enable the requested State to deal with the request, that State may ask the requesting State to amend the request or to complete it with additional information. 2. The requested State may set a time limit for the receipt of such amendments or information. 3. Pending receipt of the requested amendments or information in relation to a request under Article 665, the requested State may take any of the measures referred to in Articles 658 to 664. Article 682 Plurality of requests 1. Where the requested State receives more than one request under Article 663 or Article 665 in respect of the same person or property, the plurality of requests shall not prevent that State from dealing with the requests involving the taking of provisional measures. 2. In the case of a plurality of requests under Article 665, the requested State shall consider consulting the requesting States. Article 683 Obligation to give reasons The requested State shall give reasons for any decision to refuse, postpone or make conditional any cooperation under this Title. Article 684 Information 1. The requested State shall promptly inform the requesting State of: (a) the action initiated on the basis of a request under this Title; (b) the final result of the action carried out on the basis of a request under this Title; (c) a decision to refuse, postpone or make conditional, in whole or in part, any cooperation under this Title; (d) any circumstances which render impossible the carrying out of the action sought or are likely to delay it significantly; and (e) in the event of provisional measures taken pursuant to a request under Articles 658 to Article 663, such provisions of its domestic law as would automatically lead to the lifting of the provisional measure. 2. The requesting State shall promptly inform the requested State of: (a) any review, decision or any other fact by reason of which the confiscation order ceases to be wholly or partially enforceable; and (b) any development, factual or legal, by reason of which any action under this Title is no longer justified. 3. Where a State, on the basis of the same confiscation order, requests confiscation in more than one State, it shall inform all States which are affected by the enforcement of the order about the request. Article 685 Restriction of use 1. The requested State may make the execution of a request dependent on the condition that the information or evidence obtained is not, without its prior consent, to be used or transmitted by the authorities of the requesting State for investigations or proceedings other than those specified in the request. 2. Without the prior consent of the requested State, information or evidence provided by it under this Title shall not be used or transmitted by the authorities of the requesting State in investigations or proceedings other than those specified in the request. 3. Personal data communicated under this Title may be used by the State to which they have been transferred: (a) for the purposes of proceedings to which this Title applies; (b) for other judicial and administrative proceedings directly related to proceedings referred to in point (a); (c) for preventing an immediate and serious threat to public security; or (d) for any other purpose, only with the prior consent of the communicating State, unless the State concerned has obtained the consent of the data subject. 4. This Article shall also apply to personal data not communicated but obtained otherwise under this Title. 5. This Article does not apply to personal data obtained by the United Kingdom or a Member State under this Title and originating from that State. Article 686 Confidentiality 1. The requesting State may require that the requested State keep confidential the facts and substance of the request, except to the extent necessary to execute the request. If the requested State cannot comply with the requirement of confidentiality, it shall promptly inform the requesting State. 2. The requesting State shall, if not contrary to basic principles of its domestic law and if so requested, keep confidential any evidence and information provided by the requested State, except to the extent that its disclosure is necessary for the investigations or proceedings described in the request. 3. Subject to the provisions of its domestic law, a State which has received spontaneous information under Article 662 shall comply with any requirement of confidentiality as required by the State which supplies the information. If the receiving State cannot comply with such a requirement, it shall promptly inform the transmitting State. Article 687 Costs The ordinary costs of complying with a request shall be borne by the requested State. Where costs of a substantial or extraordinary nature are necessary to comply with a request, the requesting and requested States shall consult in order to agree the conditions on which the request is to be executed and how the costs will be borne. Article 688 Damages 1. Where legal action on liability for damages resulting from an act or omission in relation to cooperation under this Title has been initiated by a person, the States concerned shall consider consulting each other, where appropriate, to determine how to apportion any sum of damages due. 2. A State which has become the subject of litigation for damages shall endeavour to inform the other State of such litigation if that State might have an interest in the case. Article 689 Legal remedies 1. Each State shall ensure that persons affected by measures under Articles 663 to 666 have effective legal remedies in order to preserve their rights. 2. The substantive reasons for requested measures under Articles 663 to 666 shall not be challenged before a court in the requested State. TITLE XII OTHER PROVISIONS Article 690 Notifications 1. By the date of entry into force of this Agreement, the Union and the United Kingdom shall make any of the notifications provided for in Article 602(2), Article 603(2), and Article 611(4) and shall, to the extent it is possible to do so, indicate whether no such notification is to be made. To the extent that such a notification or indication has not been made in relation to a State, at the point in time referred to in the first subparagraph, notifications may be made in relation to that State as soon as possible and at the latest two months after the entry into force of this Agreement. During that interim period, any State in relation to which no notification provided for in Article 602(2), Article 603(2), or Article 611(4) has been made, and which has not been the subject of an indication that no such notification is to be made, may avail itself of the possibilities provided for in that Article as if such a notification had been made in respect of that State. In the case of Article 603(2), a State may only avail itself of the possibilities provided for in that Article to the extent that to do so is compatible with the criteria for making a notification. 2. The notifications referred to in Article 599(4), Article 605(1), Article 606(2), Article 625(1), Article 626(1), Article 659(4), Article 660(5), Article 661(5), Article 670(2), and Article 678(3) and (7) may be made at any time. 3. The notifications referred to in Article 605(1), Article 606(2) and Article 678(3) and (7) may be modified at any time. 4. The notifications referred to in Article 602(2), Article 603(2), Article 605(1), Article 611(4), Article 659(4), Article 660(5), and Article 661(5) may be withdrawn at any time. 5. The Union shall publish information on notifications of the United Kingdom referred to in Article 605(1) in the Official Journal of the European Union. 6. By the date of entry into force of this Agreement, the United Kingdom shall notify the Union of the identity of the following authorities: (a) the authority responsible for receiving and processing PNR data under Title III; (b) the authority considered as the competent law enforcement authority for the purposes of Title V and a short description of its competences; (c) the national contact point designated under Article 568(1); (d) the authority considered as the competent authority for the purposes of Title VI and a short description of its competences; (e) the contact point designated under Article 584(1); (f) the United Kingdom Domestic Correspondent for Terrorism Matters designated under Article 584(2); (g) the authority competent by virtue of domestic law of the United Kingdom to execute an arrest warrant, as referred to in point (c) of Article 598, and the authority competent by virtue of the domestic law of the United Kingdom to issue an arrest warrant, as referred to in point (d) of Article 598; (h) the authority designated by the United Kingdom under Article 623(3); (i) the central authority designated by the United Kingdom under Article 645; (j) the central authority designated by the United Kingdom under Article 676(1). The Union shall publish information about the authorities referred to in the first subparagraph in the Official Journal of the European Union. 7. By the date of entry into force of this Agreement, the Union shall, on its behalf or on behalf of its Member States as the case may be, notify the United Kingdom, of the identity of the following authorities: (a) the Passenger Information Units established or designated by each Member State for the purposes of receiving and processing PNR data under Title III; (b) the authority competent by virtue of the domestic law of each Member State to execute an arrest warrant, as referred to in point (c) of Article 598, and the authority competent by virtue of the domestic law of each Member State to issue an arrest warrant, as referred to in point (d) of Article 598; (c) the authority designated for each Member State under Article 623(3); (d) the Union body referred to in Article 634; (e) the central authority designated by each Member State under Article 645; (f) the central authority designated by each Member State under Article 676(1); (g) any Union body designated under the first sentence of Article 676(2) and whether it is also designated as a central authority under the last sentence of that paragraph. 8. The notifications made under paragraph 6 or 7 may be modified at any time. Such modifications shall be notified to the Specialised Committee on Law Enforcement and Judicial Cooperation. 9. The United Kingdom and the Union may notify more than one authority with respect to points (a), (b), (d), (e), (g), (h), (i) and (j) of paragraph 6 and with respect to paragraph 7 respectively and may limit such notifications for particular purposes only. 10. Where the Union makes the notifications referred to in this Article, it shall indicate to which of its Member States the notification applies or whether it is making the notification on its own behalf. Article 691 Review and evaluation 1. This Part shall be jointly reviewed in accordance with Article 776 or at the request of either Party where jointly agreed. 2. The Parties shall decide in advance on how the review is to be conducted and shall communicate to each other the composition of their respective review teams. The review teams shall include persons with appropriate expertise with respect to the issues under review. Subject to applicable laws, all participants in a review shall be required to respect the confidentiality of the discussions and to have appropriate security clearances. For the purposes of such reviews, the United Kingdom and the Union shall make arrangements for appropriate access to relevant documentation, systems and personnel. 3. Without prejudice to paragraph 2, the review shall in particular address the practical implementation, interpretation and development of this Part. Article 692 Termination 1. Without prejudice to Article 779, each Party may at any moment terminate this Part by written notification through diplomatic channels. In that event, this Part shall cease to be in force on the first day of the ninth month following the date of notification. 2. However, if this Part is terminated on account of the United Kingdom or a Member State having denounced the European Convention on Human Rights or Protocols 1, 6 or 13 thereto, this Part shall cease to be in force as of the date that such denunciation becomes effective or, if the notification of its termination is made after that date, on the fifteenth day following such notification. 3. If either Party gives notice of termination under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what measures are needed to ensure that any cooperation initiated under this Part is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Part before it ceases to be in force, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the termination takes effect. Article 693 Suspension 1. In the event of serious and systemic deficiencies within one Party as regards the protection of fundamental rights or the principle of the rule of law, the other Party may suspend this Part or Titles thereof, by written notification through diplomatic channels. Such notification shall specify the serious and systemic deficiencies on which the suspension is based. 2. In the event of serious and systemic deficiencies within one Party as regards the protection of personal data, including where those deficiencies have led to a relevant adequacy decision ceasing to apply, the other Party may suspend this Part or Titles thereof, by written notification through diplomatic channels. Such notification shall specify the serious and systemic deficiencies on which the suspension is based. 3. For the purposes of paragraph 2, \"relevant adequacy decision\" means: (a) in relation to the United Kingdom, a decision adopted by the European Commission, in accordance with Article 36 of Directive (EU) 2016/680 of the European Parliament and of the Council (82) or analogous successor legislation, attesting to the adequate level of protection; (b) in relation to the Union, a decision adopted by the United Kingdom attesting to the adequate level of protection for the purposes of transfers falling within the scope of Part 3 of the Data Protection Act 2018 (83) or analogous successor legislation. 4. In relation to the suspension of Title III or Title X, references to a \"relevant adequacy decision\" also include: (a) in relation to the United Kingdom, a decision adopted by the European Commission, in accordance with Article 45 of Regulation (EU) 2016/679 of the European Parliament and of the Council (84) (General Data Protection Regulation) or analogous successor legislation attesting to the adequate level of protection; (b) in relation to the Union, a decision adopted by the United Kingdom attesting to the adequate level of protection for the purposes of transfers falling within the scope of Part 2 of the Data Protection Act 2018 or analogous successor legislation. 5. The Titles concerned by the suspension shall provisionally cease to apply on the first day of the third month following the date of the notification referred to in paragraph 1 or 2, unless, no later than two weeks before the expiry of that period, as extended, as the case may be, in accordance with point (d) of paragraph 7, the Party which notified the suspension gives written notification to the other Party, through diplomatic channels, of its withdrawal of the first notification or of a reduction in scope of the suspension. In the latter case, only the Titles referred to in the second notification shall provisionally cease to apply. 6. If one Party notifies the suspension of one or several Titles of this Part pursuant to paragraph 1 or 2, the other Party may suspend all of the remaining Titles, by written notification through diplomatic channels, with three months' notice. 7. Upon the notification of a suspension pursuant to paragraph 1 or 2, the Partnership Council shall immediately be seized of the matter. The Partnership Council shall explore possible ways of allowing the Party that notified the suspension to postpone its entry into effect, to reduce its scope or to withdraw it. To that end, upon a recommendation of the Specialised Committee on Law Enforcement and Judicial Cooperation, the Partnership Council may: (a) agree on joint interpretations of provisions of this Part; (b) recommend any appropriate action to the Parties; (c) adopt appropriate adaptations to this Part which are necessary to address the reasons underlying the suspension, with a maximum validity of 12 months; and (d) extend the period referred to in paragraph 5 by up to three months. 8. If either Party gives notification of suspension under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what measures are needed to ensure that any cooperation initiated under this Part and affected by the notification is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Part before the Titles concerned by the suspension provisionally cease to apply, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the suspension takes effect. 9. The suspended Titles shall be reinstated on the first day of the month following the day on which the Party having notified the suspension pursuant to paragraph 1 or 2 has given written notification to the other Party, through diplomatic channels, of its intention to reinstate the suspended Titles. The Party having notified the suspension pursuant to paragraph 1 or 2 shall do so immediately after the serious and systemic deficiencies on the part of the other Party on which the suspension was based have ceased to exist. 10. Upon the notification of the intention to reinstate the suspended Titles in accordance with paragraph 9, the remaining Titles suspended pursuant to paragraph 6 shall be reinstated at the same time as the Titles suspended pursuant to paragraph 1 or 2. Article 694 Expenses The Parties and the Member States, including institutions, bodies, offices and agencies of the Parties or the Member States, shall bear their own expenses which arise in the course of implementation of this Part, unless otherwise provided for in this Agreement. TITLE XIII DISPUTE SETTLEMENT Article 695 Objective The objective of this Title is to establish a swift, effective and efficient mechanism for avoiding and settling disputes between the Parties concerning this Part, including disputes concerning this Part when applied to situations governed by other provisions of this Agreement, with a view to reaching a mutually agreed solution, where possible. Article 696 Scope 1. This Title applies to disputes between the Parties concerning this Part (the \"covered provisions\"). 2. The covered provisions shall include all provisions of this Part, with the exception of Articles 526 and 541, Article 552(14), Articles 562, 692, 693 and 700. Article 697 Exclusivity The Parties undertake not to submit a dispute between them regarding this Part to a mechanism of settlement other than that provided for in this Title. Article 698 Consultations 1. If a Party (the \"complaining Party\") considers that the other Party (the \"responding Party\") has breached an obligation under this Part, the Parties shall endeavour to resolve the matter by entering into consultations in good faith, with the aim of reaching a mutually agreed solution. 2. The complaining Party may seek consultations by means of a written request delivered to the responding Party. The complaining Party shall specify in its written request the reasons for the request, including identification of the acts or omissions that the complaining Party considers as giving rise to the breach of an obligation by the responding Party, specifying the covered provisions it considers applicable. 3. The responding Party shall reply to the request promptly, and no later than two weeks after the date of its delivery. Consultations shall be held regularly within a period of three months following the date of delivery of the request in person or by any other means of communication agreed by the Parties. 4. The consultations shall be concluded within three months of the date of delivery of the request, unless the Parties agree to continue the consultations. 5. The complaining Party may request that the consultations be held in the framework of the Specialised Committee on Law Enforcement and Judicial Cooperation or in the framework of the Partnership Council. The first meeting shall take place within one month of the request for consultations referred to in paragraph 2 of this Article. The Specialised Committee on Law Enforcement and Judicial Cooperation may at any time decide to refer the matter to the Partnership Council. The Partnership Council may also seize itself of the matter. The Specialised Committee on Law Enforcement and Judicial Cooperation, or as the case may be, the Partnership Council, may resolve the dispute by a decision. Such a decision shall be considered a mutually agreed solution within the meaning of Article 699. 6. The complaining Party may at any time unilaterally withdraw its request for consultations. In such a case, the consultations shall be terminated immediately. 7. Consultations, and in particular all information designated as confidential and positions taken by the Parties during consultations, shall be confidential. Article 699 Mutually agreed solution 1. The Parties may at any time reach a mutually agreed solution with respect to any dispute referred to in Article 696. 2. The mutually agreed solution may be adopted by means of a decision of the Specialised Committee on Law Enforcement and Judicial Cooperation or the Partnership Council. Where the mutually agreed solution consists of an agreement on joint interpretations of provisions of this Part by the Parties, that mutually agreed solution shall be adopted by means of a decision of the Partnership Council. 3. Each Party shall take the measures necessary to implement the mutually agreed solution within the agreed time period. 4. No later than the date of expiry of the agreed time period, the implementing Party shall inform the other Party in writing of any measures taken to implement the mutually agreed solution. Article 700 Suspension 1. Where consultations under Article 698 have not led to a mutually agreed solution within the meaning of Article 699, provided that the complaining Party has not withdrawn its request for consultations in accordance with Article 698(6), and where it considers that the respondent Party is in serious breach of its obligations under the covered provisions referred to in Article 698(2), the complaining Party may suspend the Titles of this Part to which the serious breach pertains, by written notification through diplomatic channels. Such notification shall specify the serious breach of obligations by the responding Party on which the suspension is based. 2. The Titles concerned by the suspension shall provisionally cease to apply on the first day of the third month following the date of the notification referred to in paragraph 1 or any other date mutually agreed by the Parties, unless, no later than two weeks before the expiry of that period, the complaining Party gives written notification to the responding Party, through diplomatic channels, of its withdrawal of the first notification or of a reduction in scope of the suspension. In the latter case, only the Titles referred to in the second notification shall provisionally cease to apply. 3. If the complaining Party notifies the suspension of one or several Titles of this Part pursuant to paragraph 1, the respondent Party may suspend all of the remaining Titles, by written notification through diplomatic channels, with three months' notice. 4. If a notification of suspension is given under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what measures are needed to ensure that any cooperation initiated under this Part and affected by the notification is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Part before the Titles concerned by the suspension provisionally cease to apply, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the suspension takes effect. 5. The suspended Titles shall be reinstated on the first day of the month following the date on which the complaining Party has given written notification to the respondent Party, through diplomatic channels, of its intention to reinstate the suspended Titles. The complaining Party shall do so immediately when it considers that the serious breach of the obligations on which the suspension was based has ceased to exist. 6. Upon notification by the complaining Party of its intention to reinstate the suspended Titles in accordance with paragraph 5, the remaining Titles suspended by the respondent Party pursuant to paragraph 3 shall be reinstated at the same time as the Titles suspended by the complaining Party pursuant to paragraph 1. Article 701 Time Periods 1. All time periods laid down in this Title shall be counted in weeks or months, as the case may be, from the day following the act to which they refer. 2. Any time period referred to in this Title may be modified by mutual agreement of the Parties. PART FOUR THEMATIC COOPERATION TITLE I HEALTH SECURITY Article 702 Cooperation on health security 1. For the purpose of this Article, a \"serious cross-border threat to health\" means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the borders of at least one Member State and the United Kingdom. 2. The Parties shall inform each other of a serious cross-border threat to health affecting the other Party and shall endeavour to do so in a timely manner. 3. Where there is a serious cross-border threat to health, following a written request from the United Kingdom, the Union may grant the United Kingdom ad hoc access to its Early Warning and Response System (\"EWRS\") in respect of the particular threat to enable the Parties and Member States' competent authorities to exchange relevant information, to assess public health risks, and to coordinate the measures that could be required to protect public health. The Union shall endeavour to respond to the United Kingdom's written request in a timely manner. Moreover, the Union may invite the United Kingdom to participate in a committee established within the Union and composed of representatives of Member States for the purposes of supporting the exchange of information and of coordination in relation to the serious cross-border threat to health. Both arrangements shall be on a temporary basis, and in any event for no longer than the duration that either of the Parties, having consulted the other Party, considers necessary for the relevant serious cross-border threat to health. 4. For the purposes of the information exchange referred to in paragraph 2 and any requests made pursuant to paragraph 3, each Party shall designate a focal point and notify the other Party thereof. The focal points shall also: (a) endeavour to facilitate understanding between the Parties as to whether or not a threat is a serious cross-border threat to health; (b) seek mutually agreed solutions to any technical issues arising from implementation of this Title. 5. The United Kingdom shall observe all applicable conditions for the use of the EWRS and the rules of procedure of the committee referred to in paragraph 3, for the period of access granted in respect of a particular serious cross-border threat to health. If, following clarificatory exchanges between the Parties: (a) the Union considers that the United Kingdom has not observed the above-mentioned conditions or rules of procedure, the Union may terminate the access of the United Kingdom to the EWRS or its participation in that committee, as the case may be, in respect of that threat; (b) the United Kingdom considers that it cannot accept the conditions or rules of procedure, the United Kingdom may withdraw its participation in the EWRS or its participation in that committee, as the case may be, in respect of that threat. 6. Where in their mutual interests the Parties shall cooperate in international forums on the prevention of, detection of, preparation for, and response to established and emerging threats to health security. 7. The European Centre for Disease Prevention and Control and the relevant body in the United Kingdom responsible for surveillance, epidemic intelligence and scientific advice on infectious diseases shall cooperate on technical and scientific matters of mutual interest to the Parties and, to that end, may conclude a memorandum of understanding. TITLE II CYBER SECURITY Article 703 Dialogue on cyber issues The Parties shall endeavour to establish a regular dialogue in order to exchange information about relevant policy developments, including in relation to international security, security of emerging technologies, internet governance, cybersecurity, cyber defence and cybercrime. Article 704 Cooperation on cyber issues 1. Where in their mutual interest, the Parties shall cooperate in the field of cyber issues by sharing best practices and through cooperative practical actions aimed at promoting and protecting an open, free, stable, peaceful and secure cyberspace based on the application of existing international law and norms for responsible State behaviour and regional cyber confidence-building measures. 2. The Parties shall also endeavour to cooperate in relevant international bodies and forums, and endeavour to strengthen global cyber resilience and enhance the ability of third countries to fight cybercrime effectively. Article 705 Cooperation with the Computer Emergency Response Team \u2013 European Union Subject to prior approval by the Steering Board of the Computer Emergency Response Team \u2013 European Union (CERT-EU), CERT-EU and the national UK computer emergency response team shall cooperate on a voluntary, timely and reciprocal basis to exchange information on tools and methods, such as techniques, tactics, procedures and best practices, and on general threats and vulnerabilities. Article 706 Participation in specific activities of the Cooperation Group established pursuant to Directive (EU) 2016/1148 1. With a view to promoting cooperation on cyber security while ensuring the autonomy of the Union decision-making process, the relevant national authorities of the United Kingdom may participate at the invitation, which the United Kingdom may also request, of the Chair of the Cooperation Group in consultation with the Commission, in the following activities of the Cooperation Group: (a) exchanging best practices in building capacity to ensure the security of network and information systems; (b) exchanging information with regard to exercises relating to the security of network and information systems; (c) exchanging information, experiences and best practices on risks and incidents; (d) exchanging information and best practices on awareness-raising, education programmes and training; and (e) exchanging information and best practices on research and development relating to the security of network and information systems. 2. Any exchange of information, experiences or best practices between the Cooperation Group and the relevant national authorities of the United Kingdom shall be voluntary and, where appropriate, reciprocal. Article 707 Cooperation with the European Union Agency for Cybersecurity (ENISA) 1. With a view to promoting cooperation on cyber security while ensuring the autonomy of the Union decision-making process, the United Kingdom may participate at the invitation, which the United Kingdom may also request, of the Management Board of the European Union Agency for Cybersecurity (ENISA), in the following activities carried out by ENISA: (a) capacity building; (b) knowledge and information; and (c) awareness raising and education. 2. The conditions for the participation of the United Kingdom in ENISA's activities referred to in paragraph 1, including an appropriate financial contribution, shall be set out in working arrangements adopted by the Management Board of ENISA subject to prior approval by the Commission and agreed with the United Kingdom. 3. The exchange of information, experiences and best practices between ENISA and the United Kingdom shall be voluntary and, where appropriate, reciprocal. PART FIVE PARTICIPATION IN UNION PROGRAMMES, SOUND FINANCIAL MANAGEMENT AND FINANCIAL PROVISIONS Article 708 Scope 1. This Part applies to the participation of the United Kingdom in Union programmes, activities and services thereunder, in which the Parties have agreed that the United Kingdom participates. 2. This Part shall not apply to the participation of the United Kingdom in cohesion programmes under the European territorial cooperation goal or similar programmes having the same objective, which takes place on the basis of the basic acts of one or more Union institutions applicable to those programmes. The applicable conditions for participation in the programmes referred to in the first subparagraph shall be specified in the applicable basic act and the financing agreement concluded thereunder. The Parties shall agree provisions with similar effect to Chapter 2 concerning the participation of the United Kingdom in those programmes. Article 709 Definitions For the purposes of this Part, the following definitions apply: (a) \"basic act\" means: (i) an act of one or more Union institutions establishing a programme or activity, which provides a legal basis for an action and for the implementation of the corresponding expenditure entered in the Union budget or of the budgetary guarantee backed by the Union budget, including any amendment and any relevant acts of a Union institution which supplement or implement that act, except those adopting work programmes, or (ii) an act of one or more Union institutions establishing an activity financed from the Union budget other than programmes; (b) \"funding agreement\" means agreements relating to Union programmes and activities under Protocol I on Programmes and activities in which the United Kingdom participates which implement Union funds, such as grant agreements, contribution agreements, financial framework partnership agreements, financing agreements and guarantee agreements; (c) \"other rules pertaining to the implementation of the Union programme and activity\" means rules laid down in the Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (85) (\"Financial Regulation\") that apply to the general budget of the Union, and in the work programme or in the calls or other Union award procedures; (d) \"Union\" means the Union or the European Atomic Energy Community, or both, as the context may require; (e) \"Union award procedure\" means a procedure for award of Union funding launched by the Union or by persons or entities entrusted with the implementation of Union funds; (f) \"United Kingdom entity\" means any type of entity, whether a natural person, legal person or another type of entity, which may participate in activities of a Union programme or activity in accordance with the basic act and who resides or which is established in the United Kingdom. CHAPTER 1 PARTICIPATION OF THE UNITED KINGDOM IN UNION PROGRAMMES AND ACTIVITIES SECTION 1 GENERAL CONDITIONS FOR PARTICIPATION IN UNION PROGRAMMES AND ACTIVITIES Article 710 Establishment of the participation 1. The United Kingdom shall participate in and contribute to the Union programmes, activities, or in exceptional cases, the part of Union programmes or activities, which are open to its participation, and which shall be listed in a Protocol on Programmes and activities in which the United Kingdom participates (\"Protocol I\"). 2. Protocol I shall be agreed between the Parties. It shall be adopted and may be amended by the Specialised Committee on Participation in Union Programmes. 3. Protocol I shall: (a) identify the Union programmes, activities, or in exceptional cases, the part of Union programmes or activities, in which the United Kingdom shall participate; (b) lay down the duration of participation, which shall refer to the period of time during which the United Kingdom and United Kingdom entities may apply for Union funding or may be entrusted with implementation of Union funds; (c) lay down specific conditions for the participation of the United Kingdom and United Kingdom entities, including specific modalities for the implementation of the financial conditions as identified under Article 714, specific modalities of the correction mechanism as identified under Article 716, and conditions for participation in structures created for the purposes of implementing those Union programmes or activities. These conditions shall comply with this Agreement and the basic acts and acts of one or more Union institutions establishing such structures; (d) where applicable, lay down the amount of United Kingdom's contribution to a Union programme implemented through a financial instrument or a budgetary guarantee and, where appropriate, specific modalities referred to in Article 717. Article 711 Compliance with programme rules 1. The United Kingdom shall participate in the Union programmes, activities or parts thereof listed in Protocol I under the terms and conditions established in this Agreement, in the basic acts and other rules pertaining to the implementation of Union programmes and activities. 2. The terms and conditions referred to in paragraph 1 shall include: (a) the eligibility of the United Kingdom entities and any other eligibility conditions related to the United Kingdom, in particular to the origin, place of activity or nationality; (b) the terms and conditions applicable to the submission, assessment and selection of applications and to the implementation of the actions by eligible United Kingdom entities. 3. The terms and conditions referred to in point (b) of paragraph 2 shall be equivalent to those applicable to eligible Member States entities, except in duly justified exceptional cases as provided for in the terms and conditions referred to in paragraph 1. Either party may bring to the attention of the Specialised Committee on Participation in Union Programmes the need for a discussion of duly justified exclusions. Article 712 Conditions for participation 1. The United Kingdom's participation in a Union programme or activity, or parts thereof as referred to in Article 708 shall be conditional upon the United Kingdom: (a) making every effort, within the framework of its domestic laws, to facilitate the entry and residence of persons involved in the implementation of these programmes and activities, or parts thereof, including students, researchers, trainees or volunteers; (b) ensuring, as far as it is under the control of the United Kingdom authorities, that the conditions for the persons referred to in point (a) to access services in the United Kingdom that are directly related to the implementation of the programmes or activities are the same as for United Kingdom nationals, including as regards any fees; (c) as regards participation involving exchange of or access to classified or sensitive non-classified information, having in place the appropriate agreements in accordance with Article 777. 2. In relation to the United Kingdom's participation in a Union programme or activity, or parts thereof as referred to in Article 708 the Union and its Member States shall: (a) make every effort, within the framework of Union or the Member States legislation, to facilitate the entry and residence of United Kingdom nationals involved in the implementation of these programmes and activities, or parts thereof, including students, researchers, trainees or volunteers; (b) ensure, as far as it is under the control of the Union and Member States' authorities, that the conditions for the United Kingdom nationals referred to in point (a) to access services in the Union that are directly related to the implementation of the programmes or activities are the same as for Union citizens, including as regards any fees. 3. Protocol I may lay down further specific conditions referring to this Article, which are necessary for the participation of the United Kingdom in a Union programme or activity, or parts thereof. 4. This Article is without prejudice to Article 711. 5. This Article and Article 718, are also without prejudice to any arrangements made between the United Kingdom and Ireland concerning the Common Travel Area. Article 713 Participation of the United Kingdom in the governance of programmes or activities 1. Representatives or experts of the United Kingdom, or experts designated by the United Kingdom shall be allowed to take part, as observers unless it concerns points reserved only for Member States or in relation to a programme or activity in which the United Kingdom is not participating, in the committees, expert groups meetings or other similar meetings where representatives or experts of the Member States, or experts designated by Member States take part, and which assist the European Commission in the implementation and management of the programmes, the activities or parts thereof, in which the United Kingdom participates in accordance with Article 708 or are established by the European Commission in respect of the implementation of the Union law in relation to these programmes, activities or parts thereof. The representatives or experts of the United Kingdom, or experts designated by the United Kingdom shall not be present at the time of voting. The United Kingdom shall be informed of the result of the vote. 2. Where experts or evaluators are not appointed on the basis of nationality, nationality shall not be a reason to exclude United Kingdom nationals. 3. Subject to the conditions of paragraph 1, participation of the United Kingdom's representatives in the meetings referred to in paragraph 1, or in other meetings related to the implementation of programmes or activities, shall be governed by the same rules and procedures as those applicable to representatives of the Member States, in particular speaking rights, receipt of information and documentation unless it concerns points reserved only for Member States or in relation to a programme or activity in which the United Kingdom is not participating, and the reimbursement of travel and subsistence costs. 4. Protocol I may define further modalities for the participation of experts, as well as the participation of the United Kingdom in governing boards and structures created for the purposes of implementing Union programmes or activities defined in that Protocol. SECTION 2 RULES FOR FINANCING THE PARTICIPATION IN UNION PROGRAMMES AND ACTIVITIES Article 714 Financial conditions 1. Participation of the United Kingdom or United Kingdom entities in Union programmes, activities or parts thereof shall be subject to the United Kingdom contributing financially to the corresponding funding under the Union budget. 2. The financial contribution shall take the form of the sum of: (a) a participation fee; and (b) an operational contribution. 3. The financial contribution shall take the form of an annual payment made in one or more instalments. 4. Without prejudice to Article 733, the participation fee shall be 4 % of the annual operational contribution and shall not be subject to retrospective adjustments except in relation to suspension under point (b) of Article 718(7) and termination under point (c) of Article 720(6). As of 2028 the level of the participation fee may be adjusted by the Specialised Committee on Participation in Union Programmes. 5. The operational contribution shall cover operational and support expenditure and be additional both in commitment and payment appropriations to the amounts entered in the Union budget definitively adopted for programmes or activities or exceptionally parts thereof increased, where appropriate, by external assigned revenue that does not result from financial contributions to Union programmes and activities from other donors, as defined in Protocol I. 6. The operational contribution shall be based on a contribution key defined as the ratio of the Gross Domestic Product (GDP) of the United Kingdom at market prices to the GDP of the Union at market prices. The GDPs at market prices to be applied shall be the latest available as of 1 January of the year in which the annual payment is made as provided by Statistical Office of the European Union (EUROSTAT), as soon as the arrangement referred to in Article 730 applies and according to the rules of this arrangement. Before this arrangement applies, the GDP of the United Kingdom shall be the one established on the basis of data provided by the Organisation for Economic Co-operation and Development (OECD). 7. The operational contribution shall be based on the application of the contribution key to the initial commitment appropriations increased as described in paragraph 5 entered in the Union budget definitively adopted for the applicable year for financing the Union programmes or activities or exceptionally parts thereof in which the United Kingdom participates. 8. The operational contribution of a programme, activity or part thereof for a year N may be adjusted upwards or downwards retrospectively in one or more subsequent years on the basis of the budgetary commitments made on the commitment appropriations of that year, their implementation through legal commitments and their decommitment. The first adjustment shall be made in year N+1 when the initial contribution shall be adjusted upwards or downwards by the difference between the initial contribution and an adjusted contribution calculated by applying the contribution key of year N to the sum of: (a) the amount of budgetary commitments made on commitment appropriations authorised in year N under the European Union adopted budget and on commitment appropriations corresponding to decommitments made available again; and (b) any external assigned revenue appropriations that do not result from financial contributions to Union programmes and activities from other donors as defined in Protocol I and that were available at the end of year N. Each subsequent year, until all the budgetary commitments financed under commitment appropriations originating from year N have been paid or decommitted and at the latest three years after the end of the programme or after the end of the multiannual financial framework corresponding to year N, whichever is earlier, the Union shall calculate an adjustment of the contribution of year N by reducing the United Kingdom contribution by the amount obtained by applying the contribution key of year N to the decommitments made each year on commitments of year N financed under the Union budget or from decommitments made available again. If external assigned revenue appropriations that do not result from financial contributions to Union programmes and activities from other donors as defined in Protocol I are cancelled, the contribution of the United Kingdom shall be reduced by the amount obtained by applying the contribution key of year N to the amount cancelled. In year N+2 or in subsequent years, after having made the adjustments referred to in the second, third and fourth subparagraphs, the contribution of the United Kingdom for year N shall also be reduced by an amount obtained by multiplying the contribution of the United Kingdom for year N and the ratio of: (a) the legal commitments of year N, funded under any commitment appropriations available in year N, and resulting from competitive award procedures, (i) from which the United Kingdom and the United Kingdom entities have been excluded; or (ii) for which the Specialised Committee on Participation in Union Programmes has decided, in accordance with the procedure established in Article 715 that there has been a quasi-exclusion of United Kingdom or United Kingdom entities; or (iii) for which the deadline for submission of applications has expired during the suspension referred to in Article 718 or after termination referred to in Article 720 has taken effect; or (iv) for which the participation of the United Kingdom and United Kingdom entities has been limited in accordance with Article 722(3); and (b) the total amount of legal commitments funded under any commitment appropriations of year N. This amount of legal commitments shall be calculated by taking all budgetary commitments made in year N and deducting the decommitments that have been made on these commitments in year N+1. 9. Upon request, the Union shall provide the United Kingdom with information in relation to its financial participation as included in the budgetary, accounting, performance and evaluation related information provided to the Union budgetary and discharge authorities concerning the Union programmes and activities in which the United Kingdom participates. That information shall be provided having due regard to the Union's and United Kingdom's confidentiality and data protection rules and is without prejudice to the information which the United Kingdom is entitled to receive under Chapter 2. 10. All contributions of the United Kingdom or payments from the Union, and the calculation of amounts due or to be received, shall be made in euros. 11. Subject to paragraph 5 and the second subparagraph of paragraph 8 of this Article, the detailed provisions for the implementation of this Article are set out in Annex 47. Annex 47 may be amended by the Specialised Committee on Participation in Union Programmes. Article 715 Quasi exclusion from competitive grant award procedure 1. When the United Kingdom considers that certain conditions laid down in a competitive grant award procedure amount to a quasi-exclusion of United Kingdom entities, the United Kingdom shall notify the Specialised Committee on Participation in Union Programmes before the deadline for submission of applications in the procedure concerned and shall provide justification. 2. Within three months of the deadline for submission of applications in the award procedure concerned, the Specialised Committee on Participation in Union Programmes shall examine the notification referred to in the paragraph 1 provided that the participation rate of United Kingdom entities in the award procedure concerned is at least 25 % lower compared to: (a) the average participation rate of United Kingdom entities in similar competitive award procedures not containing such a condition and launched within the three years preceding the notification; or, (b) in the absence of similar competitive award procedures, the average participation rate of United Kingdom entities in all competitive award procedures launched under the programme, or the preceding programme, as relevant, within the 3 years preceding the notification. 3. The Specialised Committee on Participation in Union Programmes shall by the end of the period referred to in paragraph 2, decide whether there has been a quasi-exclusion of the United Kingdom entities from the award procedure concerned in light of the justification provided by the United Kingdom pursuant to paragraph 1 and the effective participation rate in the award procedure concerned. 4. For the purposes of paragraphs 2 and 3, the participation rate shall be the ratio of the number of applications submitted by United Kingdom entities to the total number of applications submitted within the same award procedure. Article 716 Programmes to which an automatic correction mechanism applies 1. An automatic correction mechanism shall apply in relation to those Union programmes, activities or parts thereof for which the application of an automatic correction mechanism is provided in Protocol I. The application of that automatic correction mechanism may be limited to parts of the programme or activity specified in Protocol I, which are implemented through grants for which competitive calls are organised. Detailed rules on the identification of the parts of the programme or activity to which the automatic correction mechanism does or does not apply may be established in Protocol I. 2. The amount of the automatic correction for a programme or activity or parts thereof shall be the difference between the initial amounts of the legal commitments actually entered into with the United Kingdom or United Kingdom entities financed from commitment appropriations of the year in question and the corresponding operational contribution paid by the United Kingdom as adjusted pursuant to Article 714(8), excluding support expenditure, covering the same period if that amount is positive. 3. Any amount referred to in paragraph 2 of this Article, which for each of two consecutive years exceeds 8 % of the corresponding contribution of the United Kingdom to the programme as adjusted pursuant to Article 714(8) shall be due by the United Kingdom as an additional contribution under the automatic correction mechanism for each of those two years. 4. Detailed rules on the establishment of the relevant amounts of the legal commitments referred to in paragraph 2 of this Article, including in the case of consortia, and on the calculation of the automatic correction may be laid down in Protocol I. Article 717 Financing in relation to programmes implemented through financial instruments or budgetary guarantees 1. Where the United Kingdom participates in a Union programme, activity, or parts thereof that is implemented through a financial instrument or budgetary guarantee, the contribution of the United Kingdom to programmes implemented through financial instruments or budgetary guarantees under the Union budget implemented under Title X of the Financial Regulation applicable to the general budget of the Union shall be made in the form of cash. The amount contributed in cash shall increase the Union budgetary guarantee or the financial envelope of the financial instrument. 2. Where the United Kingdom participates in a programme referred to in paragraph 1 of this Article that is implemented by the European Investment Bank Group, if the European Investment Bank Group needs to cover losses that are not covered by the guarantee provided by the Union budget, the United Kingdom shall pay to the European Investment Bank Group a percentage of those losses equal to the ratio of the Gross Domestic Product at market prices of the United Kingdom to the sum of the Gross Domestic Product at market prices of the Member States, the United Kingdom and any other third country participating in that programme. The Gross Domestic Product at market prices to be applied shall be the latest available as of 1 January of the year in which the payment is due as provided by EUROSTAT, as soon as the arrangement referred to in Article 730 applies and according to the rules of this arrangement. Before this arrangement applies, the GDP of the United Kingdom shall be the one established on the basis of data provided by the OECD. 3. Where appropriate, modalities for the implementation of this Article, in particular ensuring that the United Kingdom receives its share of unused contributions to budgetary guarantees and financial instruments, shall be specified further in Protocol I. SECTION 3 SUSPENSION AND TERMINATION OF THE PARTICIPATION IN UNION PROGRAMMES Article 718 Suspension of the participation of the United Kingdom in a Union programme by the Union 1. The Union may unilaterally suspend the application of Protocol I, in relation to one or more Union programmes, activities, or exceptionally parts thereof in accordance with this Article, if the United Kingdom does not pay its financial contribution in accordance with Section 2 of this Chapter or if the United Kingdom introduces significant changes to one of the following conditions that existed when the United Kingdom participation in a programme, an activity or exceptionally part thereof was agreed and included in Protocol I, and if such changes have a significant impact on their implementation: (a) the conditions for entry and residence in the United Kingdom of the persons that are involved in the implementation of these programmes and activities, or parts thereof, including students, researchers, trainees or volunteers are changed. This shall apply, in particular, if the United Kingdom introduces a change in its domestic laws for the conditions for entry and residence in the United Kingdom for these persons, which discriminates between Member States; (b) there is a change in financial charges, including fees, that apply to persons referred in point (a) in order to perform the activities that they have to perform in order to implement the programme; (c) the conditions referred to in Article 712(3) are changed. 2. The Union shall notify the Specialised Committee on Participation in Union Programmes of its intention to suspend the participation of the United Kingdom in the programme or activity concerned. The Union shall identify the scope of the suspension and provide due justification. Unless the Union withdraws its notification, the suspension shall take effect 45 days following the date of notification by the Union. The date on which the suspension takes effect shall constitute the suspension reference date for the purposes of this Article. Prior to notification and suspension, and during the suspension period, the Specialised Committee on Participation in Union Programmes may discuss appropriate measures for avoiding or lifting the suspension. In case the Specialised Committee on Participation in Union Programmes finds an agreement for avoiding the suspension within the period referred to in the first subparagraph, the suspension shall not take effect. In any case, the Specialised Committee on Participation in Union Programmes shall meet during the period of 45 days to discuss the matter. 3. As of the suspension reference date the United Kingdom shall not be treated as a country participating in the Union programme, activity, or part thereof concerned by the suspension and in particular, the United Kingdom or United Kingdom entities shall no longer be eligible under the conditions laid down in Article 711 and Protocol I, with regard to Union award procedures which have not been completed yet on that date. An award procedure shall be considered completed when legal commitments have been entered into as a result of that procedure. 4. The suspension shall not affect legal commitments entered into before the suspension reference date. This Agreement shall continue to apply to such legal commitments. 5. The United Kingdom shall notify the Union as soon as it considers that compliance with the conditions for participation has been restored, and shall provide the Union with any relevant evidence to that effect. Within 30 days from that notification the Union shall assess the matter and may, for that purpose, request the United Kingdom to present additional evidence. The time needed to provide such additional evidence shall not be taken into account in the overall period for assessment. Where the Union has found that compliance with the conditions for participation is restored, it shall notify without undue delay the Specialised Committee on Participation in Union Programmes that the suspension is lifted. The lifting shall take effect on the day following the date of notification. Where the Union has found that compliance with the conditions for participation is not restored, the suspension shall remain in force. 6. The United Kingdom shall be treated again as a country participating in the Union programme or activity concerned, and in particular United Kingdom and United Kingdom entities shall be again eligible under the conditions laid down in Article 711 and Protocol I, with regard to Union award procedures under that Union programme or activity which were launched after the date on which the lifting of the suspension takes effect, or which were launched before that date, and for which the deadline for the submission of applications has not expired. 7. In case of the United Kingdom participation in a programme, activity, or part thereof being suspended, the financial contribution of the United Kingdom that is due during the period of suspension shall be established as follows: (a) the Union shall recalculate the operational contribution using the procedure described in point (a)(iii) of the fifth subparagraph of Article 714(8); (b) the participation fee shall be adjusted in line with the adjustment of the operational contribution. Article 719 Termination of the participation of the United Kingdom in a Union programme by the Union 1. If, by one year after the reference date referred to in Article 718(2) the Union has not lifted the suspension under Article 718, the Union shall either: (a) reassess the conditions under which it may offer to allow the United Kingdom to continue participating in the Union programmes, activities or parts thereof concerned and shall propose those conditions to the Specialised Committee on Participation in Union Programmes within 45 days from expiry of the one year suspension period with a view to modifying Protocol I. In the absence of an agreement on those measures by the Specialised Committee within a further period of 45 days, termination shall take effect as referred to in point (b) of this paragraph; or (b) terminate unilaterally the application of Protocol I, in relation to the Union programmes, activities or parts thereof concerned, in accordance with this Article, taking into account the impact of the change referred to in Article 718 on the implementation of the programme or activity or exceptionally parts thereof, or the amount of the unpaid contribution. 2. The Union shall notify the Specialised Committee on Participation in Union Programmes of its intention to terminate the participation of the United Kingdom in one or more Union programmes or activities pursuant to point (b) of paragraph 1. The Union shall identify the scope of the termination and provide due justification. Unless the Union withdraws its notification, the termination shall take effect 45 days following the date of notification by the Union. The date on which the termination takes effect shall constitute the termination reference date for the purposes of this Article. 3. As of the termination reference date the United Kingdom shall not be treated as a country participating in the Union programme or activity concerned by the termination, and in particular the United Kingdom or United Kingdom entities shall no longer be eligible under the conditions laid down in Article 711 and in Protocol I, with regard to Union award procedures which have not been completed yet as of that date. An award procedure shall be considered to have been completed if legal commitments have been entered into as a result of that procedure. 4. The termination shall not affect legal commitments entered into before the suspension reference date referred to in Article 718(2). This Agreement shall continue to apply to such legal commitments. 5. Where the application of Protocol I, or a part thereof, is terminated in respect of the programmes or activities or exceptionally parts thereof concerned: (a) the operational contribution covering support expenditure related to legal commitments already entered into shall continue to be due until the completion of those legal commitments or the end of the multiannual financial framework under which the legal commitment has been financed; (b) no contribution except the one referred to in point (a) shall be made in the following years. Article 720 Termination of the participation in a programme or activity in the case of substantial modification to Union programmes 1. The United Kingdom may unilaterally terminate its participation in a Union programme or activity or part thereof referred to in Protocol I where: (a) the basic act of that Union programme or activity is amended to an extent that the conditions for participation of the United Kingdom or of United Kingdom entities in that Union programme or activity have been substantially modified, in particular, as a result of a change of the objectives of the programme or activity and of the corresponding actions; or (b) the total amount of commitment appropriations as referred to in Article 714 is increased by more than 15 % compared with the initial financial envelope of that programme or activity or part thereof in which the United Kingdom participates and either the corresponding ceiling of the multiannual financial framework has been increased or the amount of external revenue referred to in Article 714(5) for the whole period of participation has been increased; or (c) the United Kingdom or United Kingdom entities are excluded from participation in part of a programme or activity on duly justified grounds, and that exclusion concerns commitment appropriations exceeding 10 % of the commitment appropriations in the Union budget definitively adopted for a year N for that programme or activity. 2. To this effect, the United Kingdom shall notify its intention to terminate Protocol I in relation to the Union programme or activity concerned, to the Specialised Committee on Participation in Union Programmes at the latest 60 days after the publication of the amendment or of the adopted annual budget or an amendment to it in the Official Journal of the European Union. The United Kingdom shall explain the reasons for which the United Kingdom considers the amendment to substantially alter the conditions of participation. The Specialised Committee on Participation in Union Programmes shall meet within 45 days of receiving the notification to discuss the matter. 3. Unless the United Kingdom withdraws its notification, the termination shall take effect 45 days following the date of notification by the United Kingdom. The date on which the termination takes effect shall constitute the reference date for the purposes of this Article. 4. As of the reference date the United Kingdom shall not be treated as a country participating in the Union programme or activity concerned by the termination, and in particular the United Kingdom or United Kingdom entities shall no longer be eligible under the conditions laid down in Article 711 and in Protocol I, with regard to Union award procedures which have not been completed yet as of that date. An award procedure shall be considered to have been completed if legal commitments have been entered into as a result of that procedure. 5. The termination shall not affect legal commitments entered into before the reference date. This Agreement shall continue to apply to such legal commitments. 6. In case of termination under this Article in respect of the programmes or activities concerned: (a) the operational contribution covering support expenditure related to legal commitments already entered into shall continue to be due until the completion of those legal commitments or the end of the multiannual financial framework under which the legal commitment has been financed; (b) the Union shall recalculate the operational contribution of the year where termination occurs using the procedure described in point (a)(iii) of the fifth subparagraph of Article 714(8). No contribution except the one referred to in point (a) of this Article shall be made in the following years; (c) the participation fee shall be adjusted in line with the adjustment of the operational contribution. SECTION 4 REVIEW OF PERFORMANCE AND FINANCIAL INCREASES Article 721 Performance review 1. A performance review procedure shall apply in accordance with the conditions laid down in this Article in relation to parts of the Union programme or activity to which the correction mechanism referred to in Article 716 applies. 2. The United Kingdom may request the Specialised Committee on Participation in Union Programmes to start the performance review procedure where the amount calculated in accordance with the method laid down in Article 716(2) is negative, and where that amount is higher than 12 % of the corresponding contributions of the United Kingdom to the programme or activity as adjusted pursuant to Article 714(8). 3. The Specialised Committee on Participation in Union Programmes, within a period of three months from the date of the request referred to in paragraph 2, shall analyse the relevant performance-related data and adopt a report proposing appropriate measures to address performance related issues. The measures referred to in the first subparagraph shall be applied for a period of twelve months after the adoption of the report. Following the application of the measures, performance data over the period in question shall be used to calculate the difference between the initial amounts due under the legal commitments actually entered into with the United Kingdom or United Kingdom entities during that calendar year and the corresponding operational contribution paid by the United Kingdom for the same year. If the difference referred to in the second subparagraph is negative and exceeds 16 % of the corresponding operational contribution, the United Kingdom may: (a) notify its intention to terminate its participation in the Union programme or part of a programme concerned by giving notice 45 days before the intended day of termination, and may terminate its participation in accordance with Article 720(3) to (6); or (b) request the Specialised Committee on Participation in Union Programmes to adopt further measures to address underperformance, including by making adaptations to the participation of the United Kingdom in the Union programme concerned and adjusting future financial contributions of the United Kingdom in respect of that programme. Article 722 Financial increases review 1. The United Kingdom may notify the Specialised Committee on Participation in Union Programmes that it objects to the amount of its contribution to a Union programme or activity if the total amount of commitment appropriations as referred to in Article 714 is increased by more than 5 % compared with the initial financial envelope for that Union programme or activity and either the corresponding ceiling has been increased or the amount of external revenue referred to in Article 714(5) for the whole period of participation has been increased. 2. The notification referred to in paragraph 1 of this Article shall be made within 60 days as of the publication date of the adopted annual budget or an amendment to it in the Official Journal of the European Union. The notification shall be without prejudice to the obligation of the United Kingdom to pay its contribution and to the application of the adjustment mechanism referred to in Article 714(8). 3. The Specialised Committee on Participation in Union Programmes shall prepare a report, propose and decide on the adoption of appropriate measures within three months from the date of the notification referred to in paragraph 2 of this Article. Those measures may include limiting the participation of the United Kingdom and United Kingdom entities to certain types of actions or award procedures or, where appropriate, a modification of Protocol I. The limitation of the United Kingdom's participation will be treated as an exclusion for the purposes of the adjustment mechanism referred to in Article 714(8). 4. Where the conditions referred to in point (b) of Article 720(1) are fulfilled, the United Kingdom may terminate its participation in a Union programme or activity referred to in Protocol I in accordance with Article 720(2) to (6). CHAPTER 2 SOUND FINANCIAL MANAGEMENT Article 723 Scope This Chapter shall apply in relation to the Union programmes, activities and services under Union programmes referred to in Protocol I and Protocol II on access of the United Kingdom to services established under certain Union programmes and activities in which the United Kingdom does not participate (Protocol II). SECTION 1 PROTECTION OF FINANCIAL INTERESTS AND RECOVERY Article 724 Conduct of activity for the purposes of sound financial management For the purposes of the application of this Chapter, the authorities of the United Kingdom and of the Union referred to in this Chapter shall cooperate closely in accordance with their respective laws and regulations. When exercising their duties in the territory of the United Kingdom, the agents and investigative bodies of the Union shall act in a manner consistent with United Kingdom law. Article 725 Reviews and audits 1. The Union shall have the right to conduct as provided in relevant funding agreements or contracts and in accordance with the applicable acts of one or more Union institutions, technical, scientific, financial, or other types of reviews and audits on the premises of any natural person residing in or legal entity established in the United Kingdom and receiving Union funding, as well as any third party involved in the implementation of Union funding residing or established in the United Kingdom. Such reviews and audits may be carried out by the agents of the institutions and bodies of the Union, in particular of the European Commission and the European Court of Auditors, or by other persons mandated by the European Commission in accordance with Union law. 2. The agents of the institutions and bodies of the Union, in particular the agents of the European Commission and the European Court of Auditors, as well as other persons mandated by the European Commission, shall have appropriate access to sites, works and documents (in electronic versions, paper versions, or both) and to all the information required in order to carry out such reviews and audits, as referred to in paragraph 1. Such access shall include the right to obtain physical or electronic copies of, and extracts from, any document or the contents of any data medium held by audited natural or legal persons, or by the audited third party. 3. The United Kingdom shall not prevent or raise any obstacle to the right of the agents and other persons referred to in paragraph 2 to enter the United Kingdom and to access the premises of the audited persons, in the exercise of their duties referred to in this Article. 4. Notwithstanding the suspension or termination of the United Kingdom's participation in a programme or activity, the suspension of part or all of the provisions of this Part and/or Protocol I or the termination of this Agreement, the reviews and audits may be carried out also after the date on which the relevant suspension or termination takes effect, on the terms laid down in the applicable acts of one or more Union institutions and as provided in the relevant funding agreements or contracts in relation to any legal commitment implementing the Union budget entered into by the Union before the date on which the relevant suspension or termination takes effect. Article 726 Fight against irregularities, fraud and other criminal offences affecting the financial interests of the Union 1. The European Commission and the European Anti-Fraud Office (OLAF) shall be authorised to carry out administrative investigations, including on-the-spot checks and inspections, in the territory of the United Kingdom. The European Commission and OLAF shall act in accordance with the Union acts governing those checks, inspections and investigations. 2. The competent United Kingdom authorities shall inform the European Commission or OLAF within a reasonable period of any fact or suspicion which has come to their notice relating to an irregularity, fraud or other illegal activity affecting the financial interests of the Union. 3. On-the-spot checks and inspections may be carried out on the premises of any natural person residing in or legal entity established in the United Kingdom and that receives Union funding under a funding agreement or a contract, as well as on the premises of any third party involved in the implementation of such Union funding residing or established in the United Kingdom. Such checks and inspections shall be prepared and conducted by the European Commission or OLAF in close collaboration with the competent United Kingdom authority designated by the United Kingdom. The designated authority shall be notified within a reasonable period before the checks and inspections of the object, purpose and legal basis of those checks and inspections, to enable it to provide assistance. To that end, the officials of the competent United Kingdom authorities may participate in the on-the-spot checks and inspections. 4. The agents of the European Commission and OLAF shall have access to all the information and documentation (in electronic versions, paper versions, or both) relating to the operations referred to in paragraph 3, which are required for the proper conduct of the on-the-spot checks and inspections. In particular, the agents of the European Commission and OLAF may copy relevant documents. 5. The European Commission or OLAF and the competent United Kingdom authorities shall decide on a case-by-case basis whether to conduct on-the-spot checks and inspections jointly, including where both parties are competent to conduct investigations. 6. Where the person, entity or another third party who is subject to an on-the-spot check or inspection resists an on-the-spot check or inspection, the United Kingdom authorities, acting in accordance with national rules and regulations, shall assist the European Commission or OLAF, to enable them to fulfil their duties in carrying out the on-the-spot check or inspection. Such assistance shall include taking the appropriate precautionary measures under national law, including measures to safeguard evidence. 7. The European Commission or OLAF shall inform the competent United Kingdom authorities of the result of such checks and inspections. In particular the European Commission or OLAF shall report as soon as possible to the competent United Kingdom authority any fact or suspicion relating to an irregularity which has come to their notice in the course of the on-the-spot check or inspection. 8. Without prejudice to application of United Kingdom law, the European Commission may impose administrative measures and penalties on legal or natural persons participating in the implementation of a programme or activity in accordance with Union legislation. 9. For the purposes of the proper implementation of this Article, the European Commission or OLAF and the United Kingdom competent authorities shall regularly exchange information and, at the request of one of the parties to this Agreement, consult each other, unless prohibited under Union legislation or under United Kingdom law. 10. In order to facilitate effective cooperation and the exchange of information with OLAF the United Kingdom shall designate a contact point. 11. The exchange of information between the European Commission or OLAF and the United Kingdom competent authorities shall comply with applicable confidentiality requirements. Personal data included in the exchange of information shall be protected in accordance with applicable rules. 12. Without prejudice to the applicability of Article 634, where any United Kingdom national, or natural persons residing in the United Kingdom, or legal entities established in the United Kingdom receive Union funding under Union programmes and activities listed in Protocol I, directly or indirectly, including in connection with any third party involved in the implementation of such Union funding, the United Kingdom authorities shall cooperate with the Union authorities or authorities of the Member States of the Union responsible for investigating, prosecuting and bringing to judgement the perpetrators of, and accomplices to, criminal offences affecting the financial interests of the Union in relation to such funding, in accordance with the applicable legislation and international instruments, to allow them to fulfil their duties. Article 727 Amendments to Articles 708, 723, 725 and 726 The Specialised Committee on Participation in Union Programmes may amend Articles 725 and 726, in particular to take account of changes of acts of one or more Union institutions. The Specialised Committee on Participation in Union Programmes may amend Article 708 and Article 723 to extend the application of this Chapter to other Union programmes, activities and services. Article 728 Recovery and enforcement 1. Decisions adopted by the European Commission imposing a pecuniary obligation on legal or natural persons other than States in relation to any claims stemming from Union programmes, activities, actions or projects shall be enforceable in the United Kingdom. The order for its enforcement shall be appended to the decision, without any other formality than a verification of the authenticity of the decision by the national authority designated for this purpose by the United Kingdom. The United Kingdom shall make known its designated national authority to the Commission and the Court of Justice of the European Union. In accordance with Article 729, the European Commission shall be entitled to notify such enforceable decisions directly to persons residing and legal entities established in the United Kingdom. The enforcement of those decisions shall take place in accordance with United Kingdom law. 2. Judgments and orders of the Court of Justice of the European Union delivered in application of an arbitration clause contained in a contract or agreement in relation to Union programmes, activities or parts thereof under Protocol I shall be enforceable in the United Kingdom in the same manner as European Commission decisions, as referred to in paragraph 1 of this Article. 3. The Court of Justice of the European Union shall have jurisdiction to review the legality of the decisions of the Commission referred to in paragraph 1 and to suspend the enforcement of such decisions. However, the Courts of the United Kingdom shall have jurisdiction over complaints alleging that enforcement is being carried out in an irregular manner. SECTION 2 OTHER RULES FOR THE IMPLEMENTATION OF UNION PROGRAMMES Article 729 Communication and exchange of information The Union institutions and bodies involved in the implementation of Union programmes or activities, or in control of such programmes or activities, shall be entitled to communicate directly, including through electronic exchange systems, with any natural person residing in the United Kingdom or legal entity established in the United Kingdom receiving Union funding, as well as with any third party involved in the implementation of Union funding that resides or is established in the United Kingdom. Such persons, entities and third parties may submit directly to the Union institutions and bodies all relevant information and documentation which they are required to submit on the basis of the Union legislation applicable to the Union programme or activity or on the basis of the contracts or funding agreements concluded to implement that programme or activity. Article 730 Statistical cooperation EUROSTAT and the United Kingdom Statistics Authority may establish an arrangement that enables cooperation on relevant statistical matters and includes that EUROSTAT, with the agreement of the United Kingdom Statistics Authority, provides statistical data on the United Kingdom for the purposes of this Part, including, in particular, data on the GDP of the United Kingdom. CHAPTER 3 ACCESS OF THE UNITED KINGDOM TO SERVICES UNDER UNION PROGRAMMES Article 731 Rules on service access 1. Where the United Kingdom does not participate in a Union programme or activity in accordance with Chapter 1, it may nevertheless have access to services provided under Union programmes and activities under the terms and conditions established in this Agreement, the basic acts and any other rules pertaining to the implementation of Union programmes and activities. 2. Protocol II shall, where appropriate: (a) identify the services under Union programmes and activities, to which the United Kingdom and United Kingdom entities shall have access; (b) lay down specific conditions for the access by the United Kingdom and United Kingdom entities. Those conditions shall comply with the conditions laid down in this Agreement and in the basic acts; (c) where applicable, specify the United Kingdom's financial or in-kind contribution with respect to a service provided under such Union programmes and activities. 3. Protocol II shall be adopted and may be amended by the Specialised Committee on Participation in Union Programmes. 4. The United Kingdom and public and private spacecraft owners and operators operating in or from the United Kingdom shall have access to the services provided under Article 5(1) of Decision No 541/2014/EU of the European Parliament and of the Council (86) in accordance with Article 5(2) of that Decision until provisions on similar access are included in Protocol II or until 31 December 2021. CHAPTER 4 REVIEWS Article 732 Review clause Four years after Protocols I and II become applicable, the Specialised Committee on Participation in Union Programmes shall review the implementation thereof on the basis of the data concerning the participation of United Kingdom entities in indirect and direct actions under the programme, parts of the programme, activities and services covered under Protocols I and II. Following a request by either Party, the Specialised Committee on Participation in Union Programmes shall discuss changes or proposed changes affecting the terms of the United Kingdom participation in any of the programmes or parts of programmes, activities and services listed in Protocols I and II, and, if necessary, may propose appropriate measures within the scope of this Agreement. CHAPTER 5 PARTICIPATION FEE IN THE YEARS 2021 TO 2026 Article 733 Participation fee in the years 2021 to 2026 The participation fee referred to in Article 714(4) shall have the following value in the years 2021 to 2026: \u2014 in 2021: 0,5 %; \u2014 in 2022: 1 %; \u2014 in 2023: 1,5 %; \u2014 in 2024: 2 %; \u2014 in 2025: 2,5 %; \u2014 in 2026: 3 %. PART SIX DISPUTE SETTLEMENT AND HORIZONTAL PROVISIONS TITLE I DISPUTE SETTLEMENT CHAPTER 1 GENERAL PROVISIONS Article 734 Objective The objective of this Title is to establish an effective and efficient mechanism for avoiding and settling disputes between the Parties concerning the interpretation and application of this Agreement and supplementing agreements with a view to reaching, where possible, a mutually agreed solution. Article 735 Scope 1. This Title applies, subject to paragraphs 2, 3, 4 and 5, to disputes between the Parties concerning the interpretation and application of the provisions of this Agreement or of any supplementing agreement (\"covered provisions\"). 2. The covered provisions shall include all provisions of this Agreement and of any supplementing agreement with the exception of: (a) Article 32(1) to (6) and Article 36; (b) Annex 12; (c) Title VII of Heading one of Part Two; (d) Title X of Heading One of Part Two; (e) Article 355(1), (2) and (4), Article 356(1) and (3), Chapter 2 of Title XI of Heading One of Part Two, Articles 371 and 372, Chapter 5 of Title XI of Heading One of Part Two, and Article 411(4) to (9); (f) Part Three, including when applying in relation to situations governed by other provisions of this Agreement; (g) Part Four; (h) Title II of Part Six; (i) Article 782; and (j) the Agreement on security procedures for exchanging and protecting classified information. 3. The Partnership Council may be seized by a Party with a view to resolving a dispute with respect to obligations arising from the provisions referred to in paragraph 2. 4. Article 736 applies to the provisions referred to in paragraph 2 of this Article. 5. Notwithstanding paragraphs 1 and 2, this Title shall not apply with respect to disputes concerning the interpretation and application of the provisions of the Protocol on Social Security Coordination or its annexes in individual cases. Article 736 Exclusivity The Parties undertake not to submit a dispute between them regarding the interpretation or application of provisions of this Agreement or of any supplementing agreement to a mechanism of settlement other than those provided for in this Agreement. Article 737 Choice of forum in case of a substantially equivalent obligation under another international agreement 1. If a dispute arises regarding a measure allegedly in breach of an obligation under this Agreement or any supplementing agreement and of a substantially equivalent obligation under another international agreement to which both Parties are party, including the WTO Agreement, the Party seeking redress shall select the forum in which to settle the dispute. 2. Once a Party has selected the forum and initiated dispute settlement procedures either under this Title or under another international agreement, that Party shall not initiate such procedures under the other international agreement with respect to the particular measure referred to in paragraph 1, unless the forum selected first fails to make findings for procedural or jurisdictional reasons. 3. For the purposes of this Article: (a) dispute settlement procedures under this Title are deemed to be initiated by a Party's request for the establishment of an arbitration tribunal under Article 739; (b) dispute settlement procedures under the WTO Agreement are deemed to be initiated by a Party's request for the establishment of a panel under Article 6 of the Understanding on Rules and Procedure Governing the Settlement of Disputes of the WTO; and (c) dispute settlement procedures under any other agreement are deemed to be initiated if they are initiated in accordance with the relevant provisions of that agreement. 4. Without prejudice to paragraph 2, nothing in this Agreement or any supplementing agreement shall preclude a Party from suspending obligations authorised by the Dispute Settlement Body of the WTO or authorised under the dispute settlement procedures of another international agreement to which the Parties are party. The WTO Agreement or any other international agreement between the Parties shall not be invoked to preclude a Party from suspending obligations under this Title. CHAPTER 2 PROCEDURE Article 738 Consultations 1. If a Party (the \"complaining Party\") considers that the other Party (the \"respondent Party\") has breached an obligation under this Agreement or under any supplementing agreement, the Parties shall endeavour to resolve the matter by entering into consultations in good faith, with the aim of reaching a mutually agreed solution. 2. The complaining Party may seek consultations by means of a written request delivered to the respondent Party. The complaining Party shall specify in its written request the reasons for the request, including the identification of the measures at issue and the legal basis for the request, and the covered provisions it considers applicable. 3. The respondent Party shall reply to the request promptly, and in any case no later than 10 days after the date of its delivery. Consultations shall be held within 30 days of the date of delivery of the request in person or by any other means of communication agreed by the Parties. If held in person, consultations shall take place in the territory of the respondent Party, unless the Parties agree otherwise. 4. The consultations shall be deemed concluded within 30 days of the date of delivery of the request, unless the Parties agree to continue consultations. 5. Consultations on matters of urgency, including those regarding perishable goods or seasonal goods or services, shall be held within 20 days of the date of delivery of the request. The consultations shall be deemed concluded within those 20 days unless the Parties agree to continue consultations. 6. Each Party shall provide sufficient factual information to allow a complete examination of the measure at issue, including an examination of how that measure could affect the application of this Agreement or any supplementing agreement. Each Party shall endeavour to ensure the participation of personnel of their competent authorities who have expertise in the matter subject to the consultations. 7. For any dispute concerning an area other than Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of Heading One or Heading Six of Part Two, at the request of the complaining Party, the consultations referred to in paragraph 3 of this Article shall be held in the framework of a Specialised Committee or of the Partnership Council. The Specialised Committee may at any time decide to refer the matter to the Partnership Council. The Partnership Council may also seize itself of the matter. The Specialised Committee, or, as the case may be, the Partnership Council, may resolve the dispute by a decision. The time periods referred to in paragraph 3 of this Article shall apply. The venue of meetings shall be governed by the rules of procedure of the Specialised Committee or, as the case may be, the Partnership Council. 8. Consultations, and in particular all information designated as confidential and positions taken by the Parties during consultations, shall be confidential, and shall be without prejudice to the rights of either Party in any further proceedings. Article 739 Arbitration procedure 1. The complaining Party may request the establishment of an arbitration tribunal if: (a) the respondent Party does not respond to the request for consultations within 10 days of the date of its delivery; (b) consultations are not held within the time periods referred to in Article 738(3), (4) or (5); (c) the Parties agree not to have consultations; or (d) consultations have been concluded without a mutually agreed solution having been reached. 2. The request for the establishment of the arbitration tribunal shall be made by means of a written request delivered to the respondent Party. In its request, the complaining Party shall explicitly identify the measure at issue and explain how that measure constitutes a breach of the covered provisions in a manner sufficient to present the legal basis for the complaint clearly. Article 740 Establishment of an arbitration tribunal 1. An arbitration tribunal shall be composed of three arbitrators. 2. No later than 10 days after the date of delivery of the request for the establishment of an arbitration tribunal, the Parties shall consult with a view to agreeing on the composition of the arbitration tribunal. 3. If the Parties do not agree on the composition of the arbitration tribunal within the time period provided for in paragraph 2 of this Article, each Party shall appoint an arbitrator from the sub-list for that Party established pursuant to Article 752 no later than five days after the expiry of the time period provided for in paragraph 2 of this Article. If a Party fails to appoint an arbitrator from its sub-list within that time period, the co-chair of the Partnership Council from the complaining Party shall select, no later than five days after the expiry of that time period, an arbitrator by lot from the sub-list of the Party that has failed to appoint an arbitrator. The co-chair of the Partnership Council from the complaining Party may delegate such selection by lot of the arbitrator. 4. If the Parties do not agree on the chairperson of the arbitration tribunal within the time period provided for in paragraph 2 of this Article, the co-chair of the Partnership Council from the complaining Party shall select, no later than five days after the expiry of that time period, the chairperson of the arbitration tribunal by lot from the sub-list of chairpersons established pursuant to Article 752. The co-chair of the Partnership Council from the complaining Party may delegate such selection by lot of the chairperson of the arbitration tribunal. 5. Should any of the lists provided for in Article 752 not be established or not contain sufficient names at the time a selection is made pursuant to paragraph 3 or 4 of this Article, the arbitrators shall be selected by lot from the individuals who have been formally proposed by one Party or both Parties in accordance with Annex 48. 6. The date of establishment of the arbitration tribunal shall be the date on which the last of the three arbitrators has notified to the Parties the acceptance of his or her appointment in accordance with Annex 48. Article 741 Requirements for arbitrators 1. All arbitrators shall: (a) have demonstrated expertise in law and international trade, including on specific matters covered by Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of Heading One of Part Two or Heading Six of Part Two, or in law and any other matter covered by this Agreement or by any supplementing agreement and, in the case of a chairperson, also have experience in dispute settlement procedures; (b) not be affiliated with or take instructions from either Party; (c) serve in their individual capacities and not take instructions from any organisation or government with regard to matters related to the dispute; and (d) comply with Annex 49. 2. All arbitrators shall be persons whose independence is beyond doubt, who possess the qualifications required for appointment to high judicial office in their respective countries or who are jurisconsults of recognised competence. 3. In view of the subject-matter of a particular dispute, the Parties may agree to derogate from the requirements listed in point (a) of paragraph 1. Article 742 Functions of the arbitration tribunal The arbitration tribunal: (a) shall make an objective assessment of the matter before it, including an objective assessment of the facts of the case and the applicability of, and conformity of the measures at issue with, the covered provisions; (b) shall set out, in its decisions and rulings, the findings of facts and law and the rationale behind any findings that it makes; and (c) should consult regularly with the Parties and provide adequate opportunities for the development of a mutually agreed solution. Article 743 Terms of reference 1. Unless the Parties agree otherwise no later than five days after the date of the establishment of the arbitration tribunal, the terms of reference of the arbitration tribunal shall be: \"to examine, in the light of the relevant covered provisions of this Agreement or of a supplementing agreement, the matter referred to in the request for the establishment of the arbitration tribunal, to decide on the conformity of the measure at issue with the provisions referred to in Article 735 and to issue a ruling in accordance with Article 745\". 2. If the Parties agree on terms of reference other than those referred to in paragraph 1, they shall notify the agreed terms of reference to the arbitration tribunal within the time period referred to in paragraph 1. Article 744 Urgent proceedings 1. If a Party so requests, the arbitration tribunal shall decide, no later than 10 days after the date of its establishment, whether the case concerns matters of urgency. 2. In cases of urgency, the applicable time periods set out in Article 745 shall be half the time prescribed therein. Article 745 Ruling of the arbitration tribunal 1. The arbitration tribunal shall deliver an interim report to the Parties within 100 days after the date of establishment of the arbitration tribunal. If the arbitration tribunal considers that this deadline cannot be met, the chairperson of the arbitration tribunal shall notify the Parties in writing, stating the reasons for the delay and the date on which the arbitration tribunal plans to deliver its interim report. The arbitration tribunal shall not deliver its interim report later than 130 days after the date of establishment of the arbitration tribunal under any circumstances. 2. Each Party may deliver to the arbitration tribunal a written request to review precise aspects of the interim report within 14 days of its delivery. A Party may comment on the other Party's request within six days of the delivery of the request. 3. If no written request to review precise aspects of the interim report is delivered within the time period referred to in paragraph 2, the interim report shall become the ruling of the arbitration tribunal. 4. The arbitration tribunal shall deliver its ruling to the Parties within 130 days of the date of establishment of the arbitration tribunal. When the arbitration tribunal considers that that deadline cannot be met, its chairperson shall notify the Parties in writing, stating the reasons for the delay and the date on which the arbitration tribunal plans to deliver its ruling. The arbitration tribunal shall not deliver its ruling later than 160 days after the date of establishment of the arbitration tribunal under any circumstances. 5. The ruling shall include a discussion of any written request by the Parties on the interim report and clearly address the comments of the Parties. 6. For greater certainty, a \"ruling\" or \"rulings\" as referred to in Articles 742, 743 and 753 and Article 754(1), (3), (4) and (6) shall be understood to refer also to the interim report of the arbitration tribunal. CHAPTER 3 COMPLIANCE Article 746 Compliance measures 1. If, in its ruling referred to in Article 745(4), the arbitration tribunal finds that the respondent Party has breached an obligation under this Agreement or under any supplementing agreement, that Party shall take the necessary measures to comply immediately with the ruling of the arbitration tribunal in order to bring itself in compliance with the covered provisions. 2. The respondent Party, no later than 30 days after delivery of the ruling, shall deliver a notification to the complaining Party of the measures which it has taken or which it envisages to take in order to comply. Article 747 Reasonable Period of Time 1. If immediate compliance is not possible, the respondent Party, no later than 30 days after delivery of the ruling referred to in Article 745(4), shall deliver a notification to the complaining Party of the length of the reasonable period of time it will require for compliance with the ruling referred to in Article 745(4). The Parties shall endeavour to agree on the length of the reasonable period of time to comply. 2. If the Parties have not agreed on the length of the reasonable period of time, the complaining Party may, at the earliest 20 days after the delivery of the notification referred to in paragraph 1, request in writing that the original arbitration tribunal determines the length of the reasonable period of time. The arbitration tribunal shall deliver its decision to the Parties within 20 days of the date of delivery of the request. 3. The respondent Party shall deliver a written notification of its progress in complying with the ruling referred to in Article 745(4) to the complaining Party at least one month before the expiry of the reasonable period of time. 4. The Parties may agree to extend the reasonable period of time. Article 748 Compliance Review 1. The respondent Party shall, no later than the date of expiry of the reasonable period of time, deliver a notification to the complaining Party of any measure that it has taken to comply with the ruling referred to in Article 745(4). 2. When the Parties disagree on the existence of, or the consistency with the covered provisions of, any measure taken to comply, the complaining Party may deliver a request, which shall be in writing, to the original arbitration tribunal to decide on the matter. The request shall identify any measure at issue and explain how that measure constitutes a breach of the covered provisions in a manner sufficient to present the legal basis for the complaint clearly. The arbitration tribunal shall deliver its decision to the Parties within 45 days of the date of delivery of the request. Article 749 Temporary Remedies 1. The respondent Party shall, at the request of and after consultations with the complaining Party, present an offer for temporary compensation if: (a) the respondent Party delivers a notification to the complaining Party that it is not possible to comply with the ruling referred to in Article 745(4); or (b) the respondent Party fails to deliver a notification of any measure taken to comply within the deadline referred to in Article 746 or before the date of expiry of the reasonable period of time; or (c) the arbitration tribunal finds that no measure taken to comply exists or that the measure taken to comply is inconsistent with the covered provisions. 2. In any of the conditions referred to in points (a), (b) and (c) of paragraph 1, the complaining Party may deliver a written notification to the respondent Party that it intends to suspend the application of obligations under the covered provisions if: (a) the complaining Party decides not to make a request under paragraph 1; or (b) the Parties do not agree on the temporary compensation within 20 days after the expiry of the reasonable period of time or the delivery of the arbitration tribunal decision under Article 748 if a request under paragraph 1 of this Article is made. The notification shall specify the level of intended suspension of obligations. 3. Suspension of obligations shall be subject to the following conditions: (a) obligations under Heading Four of Part Two, the Protocol on Social Security Coordination or its annexes or Part Five may not be suspended under this Article; (b) by way of derogation from point (a), obligations under Part Five may be suspended only where the ruling referred to in Article 745(4) concerns the interpretation and implementation of Part Five; (c) obligations outside Part Five may not be suspended where the ruling referred to in Article 745(4) concerns the interpretation and implementation of Part Five; and (d) obligations under Title II of Heading One of Part Two in respect of financial services may not be suspended under this Article, unless the ruling referred to in Article 745(4) concerns the interpretation and application of obligations under Title II of Heading One of Part two in respect of financial services. 4. Where a Party persists in not complying with a ruling of an arbitration panel established under an earlier agreement concluded between the Parties, the other Party may suspend obligations under the covered provisions referred to in Article 735. With the exception of the rule in point (a) of paragraph 3 of this Article, all rules relating to temporary remedies in case of non-compliance and to review of any such measures shall be governed by the earlier agreement. 5. The suspension of obligations shall not exceed the level equivalent to the nullification or impairment caused by the violation. 6. If the arbitration tribunal has found the violation in Heading One or Heading Three of Part Two, the suspension may be applied in another Title of the same Heading as that in which the tribunal has found the violation, in particular if the complaining party is of the view that such suspension is effective in inducing compliance. 7. If the arbitration tribunal has found the violation in Heading Two of Part Two: (a) the complaining party should first seek to suspend obligations in the same Title as that in which the arbitration tribunal has found the violation; (b) if the complaining party considers that it is not practicable or effective to suspend obligations with respect to the same Title as that in which the tribunal has found the violation, it may seek to suspend obligations in the other Title under the same Heading. 8. If the arbitration tribunal has found the violation in Heading One, Heading Two, Heading Three or Heading Five of Part Two, and if the complaining party considers that it is not practicable or effective to suspend obligations within the same Heading as that in which the arbitration tribunal has found the violation, and that the circumstances are serious enough, it may seek to suspend obligations under other covered provisions. 9. In the case of point (b) of paragraph 7 and paragraph 8, the complaining Party shall state the reasons for its decision. 10. The complaining Party may suspend the obligations 10 days after the date of delivery of the notification referred to in paragraph 2 unless the respondent Party made a request under paragraph 11. 11. If the respondent Party considers that the notified level of suspension of obligations exceeds the level equivalent to the nullification or impairment caused by the violation or that the principles and procedures set forth in point (b) of paragraph 7, paragraph 8 or paragraph 9 have not been followed, it may deliver a written request to the original arbitration tribunal before the expiry of the 10 day period set out in paragraph 10 to decide on the matter. The arbitration tribunal shall deliver its decision on the level of the suspension of obligations to the Parties within 30 days of the date of the request. Obligations shall not be suspended until the arbitration tribunal has delivered its decision. The suspension of obligations shall be consistent with that decision. 12. The arbitration tribunal acting pursuant to paragraph 11 shall not examine the nature of the obligations to be suspended but shall determine whether the level of such suspension exceeds the level equivalent to the nullification or impairment caused by the violation. However, if the matter referred to arbitration includes a claim that the principles and procedures set forth in point (b) of paragraph 7, paragraph 8 or paragraph 9 have not been followed, the arbitration tribunal shall examine that claim. In the event the arbitration tribunal determines that those principles and procedures have not been followed, the complaining party shall apply them consistently with point (b) of paragraph 7, paragraph 8 and paragraph 9. The parties shall accept the arbitration tribunal's decision as final and shall not seek a second arbitration procedure. This paragraph shall under no circumstances delay the date as of which the complaining Party is entitled to suspend obligations under this Article. 13. The suspension of obligations or the compensation referred to in this Article shall be temporary and shall not be applied after: (a) the Parties have reached a mutually agreed solution pursuant to Article 756; (b) the Parties have agreed that the measure taken to comply brings the respondent Party into compliance with the covered provisions; or (c) any measure taken to comply which the arbitration tribunal has found to be inconsistent with the covered provisions has been withdrawn or amended so as to bring the respondent Party into compliance with those covered provisions. Article 750 Review of any measure taken to comply after the adoption of temporary remedies 1. The respondent Party shall deliver a notification to the complaining Party of any measure it has taken to comply following the suspension of obligations or following the application of temporary compensation, as the case may be. With the exception of cases under paragraph 2, the complaining Party shall terminate the suspension of obligations within 30 days from the delivery of the notification. In cases where compensation has been applied, with the exception of cases under paragraph 2, the respondent Party may terminate the application of such compensation within 30 days from the delivery of its notification that it has complied. 2. If the Parties do not reach an agreement on whether the notified measure brings the respondent Party into compliance with the covered provisions within 30 days of the date of delivery of the notification, the complaining Party shall deliver a written request to the original arbitration tribunal to decide on the matter. The arbitration tribunal shall deliver its decision to the Parties within 46 days of the date of the delivery of the request. If the arbitration tribunal finds that the measure taken to comply is in conformity with the covered provisions, the suspension of obligations or compensation, as the case may be, shall be terminated. When relevant, the level of suspension of obligations or of compensation shall be adjusted in light of the arbitration tribunal decision. CHAPTER 4 COMMON PROCEDURAL PROVISIONS Article 751 Receipt of information 1. On request of a Party, or on its own initiative, the arbitration tribunal may seek from the Parties relevant information it considers necessary and appropriate. The Parties shall respond promptly and fully to any request by the arbitration tribunal for such information. 2. On request of a Party, or on its own initiative, the arbitration tribunal may seek from any source any information it considers appropriate. The arbitration tribunal may also seek the opinion of experts as it considers appropriate and subject to any terms and conditions agreed by the Parties, where applicable. 3. The arbitration tribunal shall consider amicus curiae submissions from natural persons of a Party or legal persons established in a Party in accordance with Annex 48. 4. Any information obtained by the arbitration tribunal under this Article shall be made available to the Parties and the Parties may submit comments on that information to the arbitration tribunal. Article 752 Lists of arbitrators 1. The Partnership Council shall, no later than 180 days after the date of entry into force of this Agreement, establish a list of individuals with expertise in specific sectors covered by this Agreement or its supplementing agreements who are willing and able to serve as members of an arbitration tribunal. The list shall comprise at least 15 persons and shall be composed of three sub-lists: (a) one sub-list of individuals established on the basis of proposals by the Union; (b) one sub-list of individuals established on the basis of proposals by the United Kingdom; and (c) one sub-list of individuals who are not nationals of either Party who shall serve as chairperson to the arbitration tribunal. Each sub-list shall include at least five individuals. The Partnership Council shall ensure that the list is always maintained at this minimum number of individuals. 2. The Partnership Council may establish additional lists of individuals with expertise in specific sectors covered by this Agreement or by any supplementing agreement. Subject to the agreement of the Parties, such additional lists may be used to compose the arbitration tribunal in accordance with the procedure set out in Article 740(3) and (5). Additional lists shall be composed of two sub-lists: (a) one sub-list of individuals established on the basis of proposals by the Union; and (b) one sub-list of individuals established on the basis of proposals by the United Kingdom. 3. The lists referred to in paragraphs 1 and 2 shall not comprise persons who are members, officials or other servants of the Union institutions, of the Government of a Member State, or of the Government of the United Kingdom. Article 753 Replacement of arbitrators If during dispute settlement procedures under this Title, an arbitrator is unable to participate, withdraws, or needs to be replaced because that arbitrator does not comply with the requirements of the Code of Conduct, the procedure set out in Article 740 shall apply. The time period for the delivery of the ruling or decision shall be extended for the time necessary for the appointment of the new arbitrator. Article 754 Arbitration tribunal decisions and rulings 1. The deliberations of the arbitration tribunal shall be kept confidential. The arbitration tribunal shall make every effort to draft rulings and take decisions by consensus. If this is not possible, the arbitration tribunal shall decide the matter by majority vote. In no case shall separate opinions of arbitrators be disclosed. 2. The decisions and rulings of the arbitration tribunal shall be binding on the Union and on the United Kingdom. They shall not create any rights or obligations with respect to natural or legal persons. 3. Decisions and rulings of the arbitration tribunal cannot add to or diminish the rights and obligations of the Parties under this Agreement or under any supplementing agreement. 4. For greater certainty, the arbitration tribunal shall have no jurisdiction to determine the legality of a measure alleged to constitute a breach of this Agreement or of any supplementing agreement, under the domestic law of a Party. No finding made by the arbitration tribunal when ruling on a dispute between the Parties shall bind the domestic courts or tribunals of either Party as to the meaning to be given to the domestic law of that Party. 5. For greater certainty, the courts of each Party shall have no jurisdiction in the resolution of disputes between the Parties under this Agreement. 6. Each Party shall make the rulings and decisions of the arbitration tribunal publicly available, subject to the protection of confidential information. 7. The information submitted by the Parties to the arbitration tribunal shall be treated in accordance with the confidentiality rules laid down in Annex 48. Article 755 Suspension and termination of the arbitration proceedings At the request of both Parties, the arbitration tribunal shall suspend its work at any time for a period agreed by the Parties and not exceeding 12 consecutive months. The arbitration tribunal shall resume its work before the end of the suspension period at the written request of both Parties, or at the end of the suspension period at the written request of either Party. The requesting Party shall deliver a notification to the other Party accordingly. If a Party does not request the resumption of the arbitration tribunal's work at the expiry of the suspension period, the authority of the arbitration tribunal shall lapse and the dispute settlement procedure shall be terminated. In the event of a suspension of the work of the arbitration tribunal, the relevant time periods shall be extended by the same time period for which the work of the arbitration tribunal was suspended. Article 756 Mutually agreed solution 1. The Parties may at any time reach a mutually agreed solution with respect to any dispute referred to in Article 735. 2. If a mutually agreed solution is reached during panel proceedings, the Parties shall jointly notify the agreed solution to the chairperson of the arbitration tribunal. Upon such notification, the arbitration proceedings shall be terminated. 3. The solution may be adopted by means of a decision of the Partnership Council. Mutually agreed solutions shall be made publicly available. The version disclosed to the public shall not contain any information either Party has designated as confidential. 4. Each Party shall take the measures necessary to implement the mutually agreed solution within the agreed time period. 5. No later than the date of expiry of the agreed time period, the implementing Party shall inform the other Party in writing of any measures thus taken to implement the mutually agreed solution. Article 757 Time Periods 1. All time periods laid down in this Title shall be counted in days from the day following the act to which they refer. 2. Any time period referred to in this Title may be modified by mutual agreement of the Parties. 3. The arbitration tribunal may at any time propose to the Parties to modify any time period referred to in this Title, stating the reasons for the proposal. Article 758 Costs 1. Each Party shall bear its own expenses derived from the participation in the arbitration tribunal procedure. 2. The Parties shall share jointly and equally the expenses derived from organisational matters, including the remuneration and expenses of the members of the arbitration tribunal. The remuneration of the arbitrators shall be in accordance with Annex 48. Article 759 Annexes 1. Dispute settlement procedures set out in this Title shall be governed by the rules of procedure set out in Annex 48 and conducted in accordance with Annex 49. 2. The Partnership Council may amend Annexes 48 and 49. CHAPTER 5 SPECIFIC ARRANGEMENTS FOR UNILATERAL MEASURES Article 760 Special procedures for remedial measures and rebalancing 1. For the purposes of Article 374 and Article 411(2) and (3), this Title applies with the modifications set out in this Article. 2. By way of derogation from Article 740 and Annex 48, if the Parties do not agree on the composition of the arbitration tribunal within two days, the co-chair of the Partnership Council from the complaining Party shall select, no later than one day after the expiry of the two-day time period, an arbitrator by lot from the sub-list of each Party and the chairperson of the arbitration tribunal by lot from the sub-list of chairpersons established pursuant to Article 752. The co-chair of the Partnership Council from the complaining Party may delegate such selection by lot of the arbitrator or chairperson. Each individual shall confirm his or her availability to both Parties within two days from the date on which he or she was informed of his or her appointment. The organisational meeting referred to in Rule 10 of Annex 48 shall take place within two days from the establishment of the arbitration tribunal. 3. By way of derogation from Rule 11 of Annex 48 the complaining Party shall deliver its written submission no later than seven days after the date of establishment of the arbitration tribunal. The respondent Party shall deliver its written submission no later than seven days after the date of delivery of the written submission of the complaining Party. The arbitration tribunal shall adjust any other relevant time periods of the dispute settlement procedure as necessary to ensure the timely delivery of the report. 4. Article 745 does not apply and references to the ruling in this Title shall be read as references to the ruling referred to in Article 374(10) or point (c) of Article 411(3). 5. By way of derogation from Article 748(2), the arbitration tribunal shall deliver its decision to the Parties within 30 days from the date of delivery of the request. Article 761 Suspension of obligations for the purposes of Article 374(12), Article 501(5) and Article 506(7) 1. The level of suspension of obligations shall not exceed the level equivalent to the nullification or impairment of benefits under this Agreement or under a supplementing agreement that is directly caused by the remedial or compensatory measures from the date the remedial or compensatory measures enter into effect until the date of the delivery of the arbitration ruling. 2. The level of suspension of obligations requested by the complaining Party and the determination of the level of suspension of obligations by the arbitration tribunal shall be based on facts demonstrating that the nullification or impairment arises directly from the application of the remedial or compensatory measure and affects specific goods, service suppliers, investors or other economic actors and not merely on allegation, conjecture or remote possibility. 3. The level of nullified or impaired benefits requested by the complaining Party or determined by the arbitration tribunal: (a) shall not include punitive damages, interest or hypothetical losses of profits or business opportunities; (b) shall be reduced by any prior refunds of duties, indemnification of damages or other forms of compensation already received by the concerned operators or the concerned Party; and (c) shall not include the contribution to the nullification or impairment by wilful or negligent action or omission of the concerned Party or any person or entity in relation to whom remedies are sought pursuant to the intended suspension of obligations. Article 762 Conditions for rebalancing, remedial, compensatory and safeguard measures Where a Party takes a measure under Article 374, Article 411, Article 469, Article 501, Article 506 or Article 773, that measure shall only be applied in respect of covered provisions within the meaning of Article 735 and shall comply, mutatis mutandis, with the conditions set out in Article 749(3). TITLE II BASIS FOR COOPERATION Article 763 Democracy, rule of law and human rights 1. The Parties shall continue to uphold the shared values and principles of democracy, the rule of law, and respect for human rights, which underpin their domestic and international policies. In that regard, the Parties reaffirm their respect for the Universal Declaration of Human Rights and the international human rights treaties to which they are parties. 2. The Parties shall promote such shared values and principles in international forums. The Parties shall cooperate in promoting those values and principles, including with or in third countries. Article 764 Fight against climate change 1. The Parties consider that climate change represents an existential threat to humanity and reiterate their commitment to strengthening the global response to this threat. The fight against human-caused climate change as elaborated in the United Nations Framework Convention on Climate Change (\"UNFCCC\") process, and in particular in the Paris Agreement adopted by the Conference of the Parties to the United Nations Framework Convention on Climate Change at its 21st session (the \"Paris Agreement\"), inspires the domestic and external policies of the Union and the United Kingdom. Accordingly, each Party shall respect the Paris Agreement and the process set up by the UNFCCC and refrain from acts or omissions that would materially defeat the object and purpose of the Paris Agreement. 2. The Parties shall advocate the fight against climate change in international forums, including by engaging with other countries and regions to increase their level of ambition in the reduction of greenhouse emissions. Article 765 Countering proliferation of weapons of mass destruction 1. The Parties consider that the proliferation of weapons of mass destruction (\"WMD\") and their means of delivery, to both state and non-state actors, represents one of the most serious threats to international stability and security. The Parties therefore agree to cooperate and to contribute to countering the proliferation of weapons of mass destruction and their means of delivery through full compliance with and national implementation of existing obligations under international disarmament and non-proliferation treaties and agreements and other relevant international obligations. 2. The Parties, furthermore, agree to cooperate on and to contribute to countering the proliferation of weapons of mass destruction and their means of delivery by: (a) taking steps to sign, ratify, or accede to, as appropriate, and fully implement all other relevant international instruments; and (b) establishing an effective system of national export controls, controlling the export as well as transit of WMD-related goods, including a WMD end-use control on dual use technologies and containing effective sanctions for breaches of export controls. 3. The Parties agree to establish a regular dialogue on those matters. Article 766 Small arms and light weapons and other conventional weapons 1. The Parties recognise that the illicit manufacture, transfer and circulation of small arms and light weapons (\"SALW\"), including their ammunition, their excessive accumulation, their poor management, inadequately secured stockpiles and their uncontrolled spread continue to pose a serious threat to peace and international security. 2. The Parties agree to observe and fully implement their respective obligations to deal with the illicit trade in SALW, including their ammunition, under existing international agreements and UN Security Council resolutions, as well as their respective commitments within the framework of other international instruments applicable in this area, such as the UN Programme of Action to prevent, combat and eradicate the illicit trade in SALW in all its aspects. 3. The Parties recognise the importance of domestic control systems for the transfer of conventional arms in line with existing international standards. The Parties recognise the importance of applying such controls in a responsible manner, as a contribution to international and regional peace, security and stability, and to the reduction of human suffering, as well as to the prevention of diversion of conventional weapons. 4. The Parties undertake, in that regard, to fully implement the Arms Trade Treaty and to cooperate with each other within the framework of that Treaty, including in promoting the universalisation and full implementation of that Treaty by all UN member states. 5. The Parties therefore undertake to cooperate in their efforts to regulate or improve the regulation of international trade in conventional arms and to prevent, combat and eradicate the illicit trade in arms. 6. The Parties agree to establish a regular dialogue on those matters. Article 767 The most serious crimes of concern to the international community 1. The Parties reaffirm that the most serious crimes of concern to the international community as a whole must not go unpunished and that their effective prosecution must be ensured by taking measures at the national level and by enhancing international cooperation, including with the International Criminal Court. The Parties agree to fully support the universality and integrity of the Rome Statute of the International Criminal Court and related instruments. 2. The Parties agree to establish a regular dialogue on those matters. Article 768 Counter-terrorism 1. The Parties shall cooperate at the bilateral, regional and international levels to prevent and combat acts of terrorism in all its forms and manifestations in accordance with international law, including, where applicable, international counterterrorism-related agreements, international humanitarian law and international human rights law, as well as in accordance with the principles of the Charter of the United Nations. 2. The Parties shall enhance cooperation on counter-terrorism, including preventing and countering violent extremism and the financing of terrorism, with the aim of advancing their common security interests, taking into account, the United Nations Global Counter-Terrorism Strategy and relevant United Nations Security Council resolutions, without prejudice to law enforcement and judicial cooperation in criminal matters and intelligence exchanges. 3. The Parties agree to establish a regular dialogue on those matters. This dialogue will, inter alia, aim to promote and facilitate: (a) the sharing of assessments on the terrorist threat; (b) the exchange of best practices and expertise on counter terrorism; (c) operational cooperation and exchange of information; and (d) exchanges on cooperation in the framework of multilateral organisations. Article 769 Personal data protection 1. The Parties affirm their commitment to ensuring a high level of personal data protection. They shall endeavour to work together to promote high international standards. 2. The Parties recognise that individuals have a right to the protection of personal data and privacy and that high standards in this regard contribute to trust in the digital economy and to the development of trade, and are a key enabler for effective law enforcement cooperation. To that end, the Parties shall undertake to respect, each in the framework of their respective laws and regulations, the commitments they have made in this Agreement in connection with that right. 3. The Parties shall cooperate at bilateral and multilateral levels, while respecting their respective laws and regulations. Such cooperation may include dialogue, exchanges of expertise, and cooperation on enforcement, as appropriate, with respect to personal data protection. 4. Where this Agreement or any supplementing agreement provide for the transfer of personal data, such transfer shall take place in accordance with the transferring Party's rules on international transfers of personal data. For greater certainty, this paragraph is without prejudice to the application of any specific provisions in this Agreement relating to the transfer of personal data, in particular Article 202 and Article 525, and to Title I of Part Six. Where needed, each Party will make best efforts, while respecting its rules on international transfers of personal data, to establish safeguards necessary for the transfer of personal data, taking into account any recommendations of the Partnership Council under point (h) of Article 7(4). Article 770 Global cooperation on issues of shared economic, environmental and social interest 1. The Parties recognise the importance of global cooperation to address issues of shared economic, environmental and social interest. Where it is in their mutual interest, they shall promote multilateral solutions to common problems. 2. While preserving their decision-making autonomy, and without prejudice to other provisions of this Agreement or any supplementing agreement, the Parties shall endeavour to cooperate on current and emerging global issues of common interest such as peace and security, climate change, sustainable development, cross-border pollution, environmental protection, digitalisation, public health and consumer protection, taxation, financial stability, and free and fair trade and investment. To that end, they shall endeavour to maintain a constant and effective dialogue and to coordinate their positions in multilateral organisations and forums in which the Parties participate, such as the United Nations, the Group of Seven (G-7) and the Group of Twenty (G-20), the Organisation for Economic Co-operation and Development, the International Monetary Fund, the World Bank and the World Trade Organization. Article 771 Essential elements Article 763(1), Article 764(1) and Article 765(1) constitute essential elements of the partnership established by this Agreement and any supplementing agreement. TITLE III FULFILLMENT OF OBLIGATIONS AND SAFEGUARD MEASURES Article 772 Fulfilment of obligations described as essential elements 1. If either Party considers that there has been a serious and substantial failure by the other Party to fulfil any of the obligations that are described as essential elements in Article 771, it may decide to terminate or suspend the operation of this Agreement or any supplementing agreement in whole or in part. 2. Before doing so, the Party invoking the application of this Article shall request that the Partnership Council meet immediately with a view to seeking a timely and mutually agreeable solution. If no mutually agreeable solution is found within 30 days from the date of the request to the Partnership Council, the Party may take the measures referred to in paragraph 1. 3. The measures referred to in paragraph 1 shall be in full respect of international law and shall be proportionate. Priority shall be given to the measures which least disturb the functioning of this Agreement and of any supplementing agreements. 4. The Parties consider that, for a situation to constitute a serious and substantial failure to fulfil any of the obligations described as essential elements in Article 771, its gravity and nature would have to be of an exceptional sort that threatens peace and security or that has international repercussions. For greater certainty, an act or omission which materially defeats the object and purpose of the Paris Agreement shall always be considered as a serious and substantial failure for the purposes of this Article. Article 773 Safeguard measures 1. If serious economic, societal or environmental difficulties of a sectorial or regional nature, including in relation to fishing activities and their dependent communities, that are liable to persist arise, the Party concerned may unilaterally take appropriate safeguard measures. Such safeguard measures shall be restricted with regard to their scope and duration to what is strictly necessary in order to remedy the situation. Priority shall be given to those measures which will least disturb the functioning of this Agreement. 2. The Party concerned shall, without delay, notify the other Party through the Partnership Council and shall provide all relevant information. The Parties shall immediately enter into consultations in the Partnership Council with a view to finding a mutually agreeable solution. 3. The Party concerned may not take safeguard measures until one month has elapsed after the date of notification referred to in paragraph 2, unless the consultation procedure pursuant to paragraph 2 has been jointly concluded before the expiration of the stated time limit. When exceptional circumstances requiring immediate action exclude prior examination, the Party concerned may apply forthwith the safeguard measures strictly necessary to remedy the situation. The Party concerned shall, without delay, notify the measures taken to the Partnership Council and shall provide all relevant information. 4. If a safeguard measure taken by the Party concerned creates an imbalance between the rights and obligations under this Agreement or under any supplementing agreement, the other Party may take such proportionate rebalancing measures as are strictly necessary to remedy the imbalance. Priority shall be given to those measures which will least disturb the functioning of this Agreement. Paragraphs 2 to 4 shall apply mutatis mutandis to such rebalancing measures. 5. Either Party may, without having prior recourse to consultations pursuant to Article 738, initiate the arbitration procedure referred to in Article 739 to challenge a measure taken by the other Party in application of paragraphs 1 to 5 of this Article. 6. The safeguard measures referred to in paragraph 1 and the rebalancing measures referred to in paragraph 5 may also be taken in relation to a supplementing agreement, unless otherwise provided therein. PART SEVEN FINAL PROVISIONS Article 774 Territorial scope 1. This Agreement applies to: (a) the territories to which the TEU, the TFEU and the Treaty establishing the European Atomic Energy Community are applicable, and under the conditions laid down in those Treaties; and (b) the territory of the United Kingdom. 2. This Agreement also applies to the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man to the extent set out in Heading Five of Part Two and Article 520. 3. This Agreement shall neither apply to Gibraltar nor have any effects in that territory. 4. This Agreement does not apply to the overseas territories having special relations with the United Kingdom: Anguilla; Bermuda; British Antarctic Territory; British Indian Ocean Territory; British Virgin Islands; Cayman Islands; Falkland Islands; Montserrat; Pitcairn, Henderson, Ducie and Oeno Islands; Saint Helena, Ascension and Tristan da Cunha; South Georgia and the South Sandwich Islands; and Turks and Caicos Islands. Article 775 Relationship with other agreements This Agreement and any supplementing agreement apply without prejudice to any earlier bilateral agreement between the United Kingdom of the one part and the Union and the European Atomic Energy Community of the other part. The Parties reaffirm their obligations to implement any such Agreement. Article 776 Review The Parties shall jointly review the implementation of this Agreement and supplementing agreements and any matters related thereto five years after the entry into force of this Agreement and every five years thereafter. Article 777 Classified information and sensitive non-classified information Nothing in this Agreement or in any supplementing agreement shall be construed as requiring a Party to make available classified information. Classified information or material provided by or exchanged between the Parties under this Agreement or any supplementing agreement shall be handled and protected in compliance with the Agreement on security procedures for exchanging and protecting classified information and any implementing arrangement concluded under it. The Parties shall agree upon handling instructions to ensure the protection of sensitive non-classified information exchanged between them. Article 778 Integral parts of this Agreement 1. The Protocols, Annexes, Appendices and footnotes to this Agreement shall form an integral part of this Agreement. 2. Each of the Annexes to this Agreement, including its appendices, shall form an integral part of the Section, Chapter, Title, Heading or Protocol that refers to that Annex or to which reference is made in that Annex. For greater certainty: (a) Annex 1 forms an integral part of Title III of Part One; (b) Annexes 2, 3, 4, 5, 6, 7, 8 and 9 form an integral part of Chapter 2 of Title I of Heading One of Part Two; (c) Annex 10 forms an integral part of Chapter 3 of Title I of Heading One of Part Two; (d) Annexes 11, 12, 13, 14, 15, 16 and 17 form an integral part of Chapter 4 of Title I of Heading One of Part Two; (e) Annex 18 forms an integral part of Chapter 5 of Title I of Heading One of Part Two; (f) Annexes 19, 20, 21, 22, 23 and 24 form an integral part of Title II of Heading One of Part Two; (g) Annex 25 forms an integral part of Title VI of Heading One of Part Two; (h) Annexes 26, 27, 28 and 29 form an integral part of Title VIII of Heading One of Part Two; (i) Annex 27 forms an integral part of Title XI of Heading One of Part Two; (j) Annex 30 and any annex adopted in accordance with Article 454 form an integral part of Title Two of Heading Two of Part Two; (k) Annex 31 forms an integral part of Title I of Heading Three of Part Two; (l) Annexes 32, 33 and 34 form an integral part of Title II of Heading Three of Part Two; (m) Annexes 35, 36, 37 and 38 form an integral part of Heading Five of Part Two; (n) Annex 39 forms an integral part of Title II of Part Three; (o) Annex 40 forms an integral part of Title III of Part Three; (p) Annex 41 forms an integral part of Title V of Part Three; (q) Annex 42 forms an integral part of Title VI of Part Three; (r) Annex 43 forms an integral part of Title VII of Part Three; (s) Annex 44 forms an integral part of Title IX of Part Three; (t) Annex 45 forms an integral part of Title III, Title VII and Title XI of Part Three; (u) Annex 46 forms an integral part of Title XI of Part Three; (v) Annex 47 forms an integral part of Section 2 of Chapter 1 of Part Five; (w) Annexes 48 and 49 form an integral part of Title I of Part Six; (x) the Annex to the protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties forms an integral part of the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties; (y) Annexes SSC-1, SSC-2, SSC-3, SSC-4, SSC-5, SSC-6, SSC-7 and SSC-8 and their Appendices form an integral part of the Protocol on Social Security Coordination. Article 779 Termination Either Party may terminate this Agreement by written notification through diplomatic channels. This Agreement and any supplementing agreement shall cease to be in force on the first day of the twelfth month following the date of notification. Article 780 Authentic texts This Agreement shall be drawn up in duplicate in the Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages. By 30 April 2021, all language versions of the Agreement shall be subject to a process of final legal-linguistic revision. Notwithstanding the previous sentence, the process of final legal-linguistic revision for the English version of the Agreement shall be finalised at the latest by the day referred to in Article 783(1) if that day is earlier than 30 April 2021. The language versions resulting from the above process of final legal-linguistic revision shall replace ab initio the signed versions of the Agreement and shall be established as authentic and definitive by exchange of diplomatic notes between the Parties. Article 781 Future accessions to the Union 1. The Union shall notify the United Kingdom of any new request for accession of a third country to the Union. 2. During the negotiations between the Union and a third country regarding the accession of that country to the Union (87), the Union shall endeavour to: (a) on request of the United Kingdom and, to the extent possible, provide any information regarding any matter covered by this Agreement and any supplementing agreement; and (b) take into account any concerns expressed by the United Kingdom. 3. The Partnership Council shall examine any effects of accession of a third country to the Union on this Agreement and any supplementing agreement sufficiently in advance of the date of such accession. 4. To the extent necessary, the United Kingdom and the Union shall, before the entry into force of the agreement on the accession of a third country to the Union: (a) amend this Agreement or any supplementing agreement, (b) put in place by decision of the Partnership Council any other necessary adjustments or transitional arrangements regarding this Agreement or any supplementing agreement; or (c) decide within the Partnership Council whether: (i) to apply Article 492 to the nationals of that third country; or (ii) to establish transitional arrangements as regards Article 492 in relation to that third country and its nationals once it accedes to the Union. 5. In the absence of a decision under point (c)(i) or (ii) of paragraph 4 of this Article by the entry into force of the agreement on the accession of the relevant third country to the Union, Article 492 shall not apply to nationals of that third country. 6. In the event that the Partnership Council establishes transitional arrangements as referred to in point (c)(ii) of paragraph 4, it shall specify their duration. The Partnership Council may extend the duration of those transitional arrangements. 7. Before the expiry of the transitional arrangements referred to in point (c)(ii) of paragraph 4 of this Article, the Partnership Council shall decide whether to apply Article 492 to the nationals of that third country from the end of the transitional arrangements. In the absence of such a decision Article 492 shall not apply in relation to the nationals of that third country from the end of the transitional arrangements. 8. Point (c) of paragraph 4, and paragraphs 5 to 7 are without prejudice to the Union's prerogatives under its domestic legislation. 9. For greater certainty, without prejudice to point (c) of paragraph 4 and paragraphs 5 to 7, this Agreement shall apply in relation to a new Member State of the Union from the date of accession of that new Member State to the Union. Article 782 Interim provision for transmission of personal data to the United Kingdom 1. For the duration of the specified period, transmission of personal data from the Union to the United Kingdom shall not be considered as a transfer to a third country under Union law, provided that the data protection legislation of the United Kingdom on 31 December 2020, as it is saved and incorporated into United Kingdom law by the European Union (Withdrawal) Act 2018 and as modified by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (SI 2019/419) (88) (the \"applicable data protection regime\"), applies and provided that the United Kingdom does not exercise the designated powers without the agreement of the Union within the Partnership Council. 2. Subject to paragraphs 3 to 11, paragraph 1 shall also apply in respect of transfers of personal data from Iceland, the Principality of Liechtenstein and the Kingdom of Norway to the United Kingdom during the specified period made under Union law as applied in those states by the Agreement on the European Economic Area done at Porto on 2 May 1992, for so long as paragraph 1 applies to transfers of personal data from the Union to the United Kingdom, provided that those states notify both Parties in writing of their express acceptance to apply this provision. 3. For the purposes of this Article, the \"designated powers\" means the powers: (a) to make regulations pursuant to sections 17A, 17C and 74A of the UK Data Protection Act 2018; (b) to issue a new document specifying standard data protection clauses pursuant to section 119A of the UK Data Protection Act 2018; (c) to approve a new draft code of conduct pursuant to Article 40(5) of the UK General Data Protection Regulation (\"UK GDPR\"), other than a code of conduct which cannot be relied on to provide appropriate safeguards for transfers of personal data to a third country under Article 46(2)(e) of the UK GDPR; (d) to approve new certification mechanisms pursuant to Article 42(5) of the UK GDPR, other than certification mechanisms which cannot be relied on to provide appropriate safeguards for transfers of personal data to a third country under Article 46(2)(f) of the UK GDPR; (e) to approve new binding corporate rules pursuant to Article 47 of the UK GDPR; (f) to authorise new contractual clauses referred to in Article 46(3)(a) of the UK GDPR; or (g) to authorise new administrative arrangements referred to in Article 46(3)(b) of the UK GDPR. 4. The \"specified period\" begins on the date of entry into force of this Agreement and, subject to paragraph 5, ends on one of the following dates, whichever is earlier: (a) on the date on which adequacy decisions in relation to the United Kingdom are adopted by the European Commission under Article 36(3) of Directive (EU) 2016/680 and under Article 45(3) of Regulation (EU) 2016/679, or (b) on the date four months after the date on which the specified period begins, which period shall be extended by two further months unless one of the Parties objects. 5. Subject to paragraphs 6 and 7, if, during the specified period, the United Kingdom amends the applicable data protection regime or exercises the designated powers without the agreement of the Union within the Partnership Council, the specified period shall end on the date on which the powers are exercised or the amendment comes into force. 6. The references to exercising the designated powers in paragraphs 1 and 5 do not include the exercise of such powers the effect of which is limited to alignment with the relevant Union data protection law. 7. Anything that would otherwise be an amendment to the applicable data protection regime which is: (a) made with the agreement of the Union within the Partnership Council; or (b) limited to alignment with the relevant Union data protection law; shall not be treated as an amendment to the applicable data protection regime for the purposes of paragraph 5 and instead should be treated as being part of the applicable data protection regime for the purposes of paragraph 1. 8. For the purposes of paragraphs 1, 5 and 7, \"the agreement of the Union within the Partnership Council\" means: (a) a decision of the Partnership Council as described in paragraph 11; or (b) deemed agreement as described in paragraph 10. 9. Where the United Kingdom notifies the Union that it proposes to exercise the designated powers or proposes to amend the applicable data protection regime, either party may request, within five working days, a meeting of the Partnership Council which must take place within two weeks of such request. 10. If no such meeting is requested, the Union is deemed to have given agreement to such exercise or amendment during the specified period. 11. If such a meeting is requested, at that meeting the Partnership Council shall consider the proposed exercise or amendment and may adopt a decision stating that it agrees to the exercise or amendment during the specified period. 12. The United Kingdom shall, as far as is reasonably possible, notify the Union when, during the specified period, it enters into a new instrument which can be relied on to transfer personal data to a third country under Article 46(2)(a) of the UK GDPR or section 75(1)(a) of the UK Data Protection Act 2018 during the specified period. Following a notification by the United Kingdom under this paragraph, the Union may request a meeting of the Partnership Council to discuss the relevant instrument. 13. Title I of Part Six does not apply in respect of disputes regarding the interpretation and application of this Article. Article 783 Entry into force and provisional application 1. This Agreement shall enter into force on the first day of the month following that in which both Parties have notified each other that they have completed their respective internal requirements and procedures for establishing their consent to be bound. 2. The Parties agree to provisionally apply this Agreement from 1 January 2021 provided that prior to that date they have notified each other that their respective internal requirements and procedures necessary for provisional application have been completed. Provisional application shall cease on one of the following dates, whichever is the earliest: (a) 28 February 2021 or another date as decided by the Partnership Council; or (b) the day referred to in paragraph 1. 3. As from the date from which this Agreement is provisionally applied, the Parties shall understand references in this Agreement to \"the date of entry into force of this Agreement\" or to \"the entry into force of this Agreement\" as references to the date from which this Agreement is provisionally applied. \u0421\u044a\u0441\u0442\u0430\u0432\u0435\u043d\u043e \u0432 \u0411\u0440\u044e\u043a\u0441\u0435\u043b \u0438 \u041b\u043e\u043d\u0434\u043e\u043d \u043d\u0430 \u0442\u0440\u0438\u0434\u0435\u0441\u0435\u0442\u0438 \u0434\u0435\u043a\u0435\u043c\u0432\u0440\u0438 \u0434\u0432\u0435 \u0445\u0438\u043b\u044f\u0434\u0438 \u0438 \u0434\u0432\u0430\u0434\u0435\u0441\u0435\u0442\u0430 \u0433\u043e\u0434\u0438\u043d\u0430. Hecho en Bruselas y Londres, el treinta de diciembre de dos mil veinte. V Bruselu a v Lond\u00fdn\u011b dne t\u0159ic\u00e1t\u00e9ho prosince dva tis\u00edce dvacet. Udf\u00e6rdiget i Bruxelles og London, den tredivte december to tusind og tyve. Geschehen zu Br\u00fcssel und London am drei\u00dfigsten Dezember zweitausendzwanzigt. Kahe tuhande kahek\u00fcmnenda aasta detsembrikuu kolmek\u00fcmnendal p\u00e4eval Br\u00fcsselis ja Londonis. \u0388\u03b3\u03b9\u03bd\u03b5 \u03c3\u03c4\u03b9\u03c2 \u0392\u03c1\u03c5\u03be\u03ad\u03bb\u03bb\u03b5\u03c2 \u03ba\u03b1\u03b9 \u03c3\u03c4\u03bf \u039b\u03bf\u03bd\u03b4\u03af\u03bd\u03bf, \u03c3\u03c4\u03b9\u03c2 \u03c4\u03c1\u03b9\u03ac\u03bd\u03c4\u03b1 \u0394\u03b5\u03ba\u03b5\u03bc\u03b2\u03c1\u03af\u03bf\u03c5 \u03b4\u03cd\u03bf \u03c7\u03b9\u03bb\u03b9\u03ac\u03b4\u03b5\u03c2 \u03b5\u03af\u03ba\u03bf\u03c3\u03b9. Done at Brussels and London on the thirtieth day of December in the year two thousand and twenty. Fait \u00e0 Bruxelles et \u00e0 Londres, le trente d\u00e9cembre deux mille vingt. Arna dh\u00e9anamh sa Bhruis\u00e9il agus i Londain, an tr\u00edochad\u00fa l\u00e1 de mh\u00ed na Nollag an bhliain dh\u00e1 mh\u00edle fiche. Sastavljeno u Bruxellesu i Londonu tridesetog prosinca godine dvije tisu\u0107e dvadesete. Fatto a Bruxelles e Londra, add\u00ec trenta dicembre duemilaventi. Brisel\u0113 un London\u0101, divi t\u016bksto\u0161i divdesmit\u0101 gada tr\u012bsdesmitaj\u0101 decembr\u012b. Priimta du t\u016bkstan\u010diai dvide\u0161imt\u0173 met\u0173 gruod\u017eio trisde\u0161imt\u0105 dien\u0105 Briuselyje ir Londone. Kelt Br\u00fcsszelben \u00e9s Londonban, a k\u00e9tezer-huszadik \u00e9v december hav\u00e1nak harmincadik napj\u00e1n. Mag\u0127mul fi Brussell u Londra, fit-tletin jum ta\u2019 Di\u010bembru fis-sena elfejn u g\u0127oxrin. Gedaan te Brussel en Londen, dertig december tweeduizend twintig. Sporz\u0105dzono w Brukseli i Londynie dnia trzydziestego grudnia roku dwa tysi\u0105ce dwudziestego. Feito em Bruxelas e em Londres, em trinta de dezembro de dois mil e vinte. \u00centocmit la Bruxelles \u0219i la Londra la treizeci decembrie dou\u0103 mii dou\u0103zeci. V Bruseli a Lond\u00fdne tridsiateho decembra dvetis\u00edcdvadsa\u0165. V Bruslju in Londonu, tridesetega decembra dva tiso\u010d dvajset. Tehty Brysseliss\u00e4 ja Lontoossa kolmantenakymmenenten\u00e4 p\u00e4iv\u00e4n\u00e4 joulukuuta vuonna kaksituhattakaksikymment\u00e4. Som skedde i Bryssel och i London den trettionde december \u00e5r tjugohundratjugo. (1) For the purpose of this Article, interested parties shall be defined as per Article 6.11 of the Anti-dumping Agreement and Article 12.9 of the SCM Agreement. (2) Preserving operations such as chilling, freezing or ventilating are considered insufficient within the meaning of point (a), whereas operations such as pickling, drying or smoking that are intended to give a product special or different characteristics are not considered insufficient. (3) The period will be of 12 months for requests of information pursuant to Article 62(2) addressed to the customs authority of the exporting Party during the first three months of the application of this Agreement. (4) G/TBT/9, 13 November 2000, Annex 4. (5) For greater certainty, it is understood that, in particular for the purposes of this Chapter, the notion of \"person\" includes any association of persons lacking the legal status of a legal person but recognized under applicable law as having the capacity to perform legal acts. (6) Air services or related services in support of air services include, but are not limited to, the following services: air transportation; services provided by using an aircraft whose primary purpose is not the transportation of goods or passengers, such as aerial fire-fighting, flight training, sightseeing, spraying, surveying, mapping, photography, parachute jumping, glider towing, helicopter-lift for logging and construction, and other airborne agricultural, industrial and inspection services; the rental of aircraft with crew; and airport operation services. (7) National maritime cabotage covers: for the Union, without prejudice to the scope of activities that may be considered cabotage under the relevant national legislation, transportation of passengers or goods between a port or point located in a Member State and another port or point located in that same Member State, including on its continental shelf, as provided for in the United Nations Convention on the Law of the Sea and traffic originating and terminating in the same port or point located in a Member State; for the United Kingdom, transportation of passengers or goods between a port or point located in the United Kingdom and another port or point located in the United Kingdom, including on its continental shelf, as provided for in the United Nations Convention on the Law of the Sea and traffic originating and terminating in the same port or point located in the United Kingdom. (8) For greater certainty, the term \"activities performed in the exercise of governmental authority\" when used in relation to measures of a Party affecting the supply of services, includes \"services supplied in the exercise of governmental authority\" as defined in point (p) of Article 124. (9) For greater certainty, the shipping companies referred to in this point are only considered as legal persons of a Party with respect to their activities relating to the supply of maritime transport services. (10) Points (a)(i) to (iii) of Article 128 do not cover measures taken in order to limit the production of an agricultural or fishery product. (11) Point (a)(iii) of Article 128 does not cover measures by a Party which limit inputs for the supply of services. (12) For greater certainty, point (f) of Article 132(1) is without prejudice to the provisions of Article 207. (13) Point (a) (iii) of Article 135 does not cover measures by a Party which limit inputs for the supply of services. (14) Where the degree or qualification has not been obtained in the Party where the service is supplied, that Party may evaluate whether this is equivalent to a university degree required in its territory. (15) Where the degree or qualification has not been obtained in the Party where the service is supplied, that Party may evaluate whether this is equivalent to a university degree required in its territory. (16) Managers and specialists may be required to demonstrate they possess the professional qualifications and experience needed in the legal person to which they are transferred. (17) While managers do not directly perform tasks concerning the actual supply of the services, this does not prevent them, in the course of executing their duties as described above, from performing such tasks as may be necessary for the provision of the services. (18) The recipient enterprise may be required to submit a training programme covering the duration of the stay for prior approval, demonstrating that the purpose of the stay is for training. For AT, CZ, DE, FR, ES, HU and LT, training must be linked to the university degree which has been obtained. (19) Balancing resource constraints against the potential burden on businesses, in cases where it is reasonable to do so, competent authorities may require that all information is submitted in a specified format to consider it \"complete for the purposes of processing\". (20) Competent authorities may meet the requirement set out in point (ii) by informing an applicant in advance in writing, including through a published measure, that a lack of response after a specified period of time from the date of submission of the application indicates acceptance of the application. The reference to \"in writing\" should be understood as including electronic format. (21) Such \"opportunity\" does not require a competent authority to provide extensions of deadlines. (22) Competent authorities are not responsible for delays due to reasons outside their competence. (23) For greater certainty, this Article shall not be construed to prevent the negotiation and conclusion of one or more agreements between the Parties on the recognition of professional qualifications on conditions and requirements different from those provided for in this Article. (24) For greater certainty, such arrangements shall not lead to the automatic recognition of qualifications but shall set, in the mutual interest of both Parties, the conditions for the competent authorities granting recognition. (25) Information requested shall be treated in accordance with the requirements of confidentiality. (26) Administrative fees do not include payments for rights to use scarce resources and mandated contributions to universal service provision. (27) For the purposes of this Article, \"non-discriminatory\" means most-favoured-nation and national treatment as defined in Articles 129, 130, 136 and 137, as well as under terms and conditions no less favourable than those accorded to any other user of like public telecommunications networks or services in like situations. (28) This Article does not apply to intra-European Union roaming services, which are commercial mobile services provided pursuant to a commercial agreement between suppliers of public telecommunications services that enable an end user to use its home mobile handset or other device for voice, data or messaging services in a Member State other than that in which the end user's home public telecommunications network is located. (29) For greater certainty, this modification applies to \"services supplied in the exercise of governmental authority\" in point (o) of Article 124 as it applies to \"activities performed in the exercise of governmental authority\" in point (f) of Article 124. (30) For greater certainty, this shall not prevent a Party from adopting or maintaining measures for prudential reasons in relation to branches established in its territory by legal persons in the other Party. (31) For greater certainty, for the purposes of this Title, Union law is part of the home jurisdiction law of the lawyers referred to in point (e)(i) of this Article. (32) \"Legal arbitration, conciliation and mediation services\" means the preparation of documents to be submitted to, the preparation for and appearance before, an arbitrator, conciliator or mediator in any dispute involving the application and interpretation of law. It does not include arbitration, conciliation and mediation services in disputes not involving the application and interpretation of law, which fall under services incidental to management consulting. It also does not include acting as an arbitrator, conciliator or mediator. As a sub-category, international legal arbitration, conciliation or mediation services refers to the same services when the dispute involves parties from two or more countries. (33) For greater certainty, for the purposes of this paragraph \"designated legal services\" means, for services supplied in the Union, legal services in relation to the law of the United Kingdom or any part of it and public international law (excluding Union law), and for services supplied in the United Kingdom, legal services in relation to the law of the Member States (including Union law) and public international law (excluding Union law). (34) For greater certainty, \"conditions of general application\" refer to conditions formulated in objective terms that apply horizontally to an unidentified number of economic operators and thus cover a range of situations and cases. (35) For greater certainty, serious balance of payments or external financial difficulties, or threat thereof, may be caused among other factors by serious difficulties related to monetary or exchange rate policies, or threat thereof. (36) Each Party may determine the relevant date of filing of the application in accordance with its own legislation. (37) This section does not apply to the protection known in the United Kingdom as a design right. (38) For the purposes of this Title, the term \"plant protection product\" shall be defined for each Party by the respective legislations of the Parties. (39) For greater certainty, and in so far as permitted by the law of a Party, the term \"federations and associations\" includes at least collective rights management bodies and professional defence bodies which are regularly recognised as having the right to represent holders of intellectual property rights. (40) For the Union the competent authority means the customs authorities. (41) For greater certainty, application of the national treatment obligation provided for in this Article is subject to the exceptions referred to in note 3 of the Notes of Sub-sections B1 and B2 of Section B of Annex 25. (42) Regulation (EU) 2019/942 of the European Parliament and of the Council of 5 June 2019 establishing a European Union Agency for the Cooperation of Energy Regulators (OJ EU L 158, 14.6.2019, p. 22). (43) Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (OJ EU L 158, 14.6.2019, p. 54) or its predecessors: OJ EU L 176, 15.7.2003, p.1 and OJ EU L 211, 14.8.2009, p. 15. (44) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas (OJ EU L 211, 14.8.2009, p. 94) or its predecessor: OJ EU L 176, 15.7.2003, p. 57. (45) Commission Regulation (EU) No 838/2010 of 23 September 2010 on laying down guidelines relating to the inter-transmission system operator compensation mechanism and a common regulatory approach to transmission charging (OJ EU L 250, 24.9.2010, p. 5). (46) Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (OJ EU L 211, 14.8.2009, p. 36). (47) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ EU L 328, 21.12.2018, p. 82). (48) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency (OJ EU L 315, 14.11.2012, p.1). (49) For the Union, such principles include the precautionary principle. (50) For the United Kingdom, \"small and medium-sized enterprises\" means small and micro-sized businesses. (51) In the case of the United Kingdom, major regulatory measures shall be understood as significant regulatory measures in accordance with the definition of such measures in the United Kingdom's rules and procedures. (52) For greater certainty, in relation to the implementation of this Agreement in the territory of the Union, the precautionary approach refers to the precautionary principle. (53) For this purpose, discrimination means that there is less favourable treatment of an economic actor compared with others in like situations and that that differential treatment is not justified by objective criteria. (54) For greater certainty, this standard is met when the facts demonstrate that the granting of a subsidy, without having been made legally contingent upon export performance, is in fact tied to actual or anticipated exportation or export earnings. The mere fact that a subsidy is granted to economic actors which export shall not for that reason alone be considered to be an export subsidy within the meaning of this provision. (55) The marketable risk countries are the United Kingdom, the Member States of the Union, Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, and the United States of America. (56) For greater certainty, this is without prejudice to Article 364(1) and (2). (57) For greater certainty, the law of the United Kingdom for the purposes of this Article does not include any law [i] having effect by virtue of section 2(1) of the European Communities Act 1972, as saved by section 1A of the European Union (Withdrawal) Act 2018, or [ii] passed or made under, or for a purpose specified in, section 2(2) of the European Communities Act 1972. (58) For the United Kingdom, this Article requires a new remedy of recovery which would be available at the end of a successful judicial review, in accordance with the standard of review under national law, commenced within the specified time period; such review is not expanded in any other way, in accordance with Article 372(3). No beneficiary would be able to raise a legitimate expectation to resist such recovery. (59) The Parties note that the United Kingdom will implement a new system of subsidy control subsequent to the entry into force of this Agreement. (60) National maritime cabotage covers: for the Union, without prejudice to the scope of activities which may be considered as cabotage under the relevant national legislation, transportation of passengers or goods between a port or point located in a Member State of the Union and another port or point located in that same Member State of the Union, including on its continental shelf, as provided for in the United Nations Convention on the Law of the Sea, and traffic originating and terminating in the same port or point located in a Member State of the Union; for the United Kingdom, transportation of passengers or goods between a port or point located in the United Kingdom and another port or point located in the United Kingdom, including on its continental shelf, as provided for in the United Nations Convention on the Law of the Sea, and traffic originating and terminating in the same port or point located in the United Kingdom. (61) For greater certainty, this paragraph shall not apply with respect to the purchase or sale of shares, stock or other forms of equity by a covered entity as a means of its equity participation in another enterprise. (62) For greater certainty, this Chapter and Article 411 do not apply to the Parties' law and standards relating to social security and pensions. (63) Each Party maintains its right to determine its priorities, policies and the allocation of resources in the effective implementation of the ILO Conventions and the relevant provisions of the European Social Charter in a manner consistent with its international commitments, including those under this Title. The Council of Europe, established in 1949, adopted the European Social Charter in 1961, which was revised in 1996. All Member States have ratified the European Social Charter in its original or revised version. For the United Kingdom, the reference to the European Social Charter in paragraph 5 refers to the original 1961 version. (64) For greater certainty, in this case the Party shall not have prior recourse to consultations in accordance with Article 738. (65) Such measures may include withdrawal or adjustment of the rebalancing measures, as appropriate. (66) Suspension of obligations under Article 749 shall be available only if rebalancing measures have in fact been applied. (67) The public security and public order exceptions may be invoked only where a genuine and sufficiently serious threat is posed to one of the fundamental interests of society. (68) For greater certainty, such determination shall be without prejudice to Title I of Part Six. (69) Measures that are aimed at ensuring the equitable or effective imposition or collection of direct taxes include measures taken by a Party under its taxation system which: (i) apply to non-resident service suppliers in recognition of the fact that the tax obligation of non-residents is determined with respect to taxable items sourced or located in the Party's territory; or (ii) apply to non-residents in order to ensure the imposition or collection of taxes in the Party's territory; or (iii) apply to non-residents or residents in order to prevent the avoidance or evasion of taxes, including compliance measures; or (iv) apply to consumers of services supplied in or from the territory of the other Party or of a third country in order to ensure the imposition or collection of taxes on such consumers derived from sources in the Party's territory; or (v) distinguish service suppliers subject to tax on worldwide taxable items from other service suppliers, in recognition of the difference in the nature of the tax base between them; or (vi) determine, allocate or apportion income, profit, gain, loss, deduction or credit of resident persons or branches, or between related persons or branches of the same person, in order to safeguard the Party's tax base. (70) Regulation (EC) No 1073/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international market for coach and bus services, and amending Regulation (EC) No 561/2006 (recast) (OJ EU L 300, 14.11.2009, p. 88). (71) For greater certainty, the term \"measure\" includes failures to act. (72) This does not include natural persons residing in the territory referred to in Article 774(3). (73) The definition of natural person also includes persons permanently residing in the Republic of Latvia who are not citizens of the Republic of Latvia or any other state but who are entitled, under the law of the Republic of Latvia, to receive a non-citizen's passport. (74) For greater certainty, the \"GPA\" shall be understood to be the GPA as amended by the Protocol Amending the Agreement on Government Procurement, done at Geneva on 30 March 2012. (75) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (recast) (OJ EU L 269, 10.10.2013, p. 1). (76) For greater certainty, for the Union, the areas beyond each Party's territorial sea shall be understood as the respective areas of the Member States of the Union. (77) Council Decision 2008/615/JHA of 23 June 2008 on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime (OJ EU L 210, 6.8.2008, p. 1). (78) Council Decision 2008/616/JHA of 23 June 2008 on the implementation of Decision 2008/615/JHA on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime (OJ EU L 210, 6.8.2008, p. 12). (79) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ EU L 135, 24.5.2016, p. 53). (80) Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ EU L 295, 21.11.2018, p. 138). (81) Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (OJ EU L 190, 18.7.2002, p. 1). (82) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ EU L 119, 4.5.2016, p. 89). (83) 2018 chapter 12. (84) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) (OJ EU L 119, 4.5.2016, p. 1). (85) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ EU L 193, 30.7.2018, p. 1). (86) Decision No 541/2014/EU of the European Parliament and of the Council of 16 April 2014 establishing a Framework for Space Surveillance and Tracking Support (OJ EU L 158, 27.5.2014, p. 227). (87) For greater certainty, paragraphs 2 to 9 apply in respect of negotiations between the Union and a third country for accession to the Union taking place after the entry into force of this Agreement, notwithstanding the fact a request for accession took place before the entry into force of this Agreement. (88) As amended by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2020 (SI 2020/1586). ANNEX 1 RULES OF PROCEDURE OF THE PARTNERSHIP COUNCIL AND COMMITTEES Rule 1 Chair 1. The Union and the United Kingdom shall notify each other of the name, position and contact details of their respective designated co-chairs. A co-chair is deemed to have the authorisation for representing, respectively, the Union or the United Kingdom until the date a new co-chair has been notified to the other Party. 2. The decisions of the co-chairs provided for by these Rules of Procedure shall be taken by mutual consent. 3. A co-chair may be replaced for a particular meeting by a designee. The co-chair, or his or her designee, shall notify the other co-chair and the Secretariat of the Partnership Council of the designation as early as possible. Any reference in these Rules of Procedure to the co-chairs shall be understood to include a designee. Rule 2 Secretariat The Secretariat of the Partnership Council (the \"Secretariat\") shall be composed of an official of the Union and an official of the Government of the United Kingdom. The Secretariat shall perform the tasks conferred on it by these Rules of Procedure. The Union and the United Kingdom shall notify each other of the name, position and contact details of the official who is the member of the Secretariat of the Partnership Council for the Union and the United Kingdom, respectively. This official is deemed to continue acting as member of the Secretariat for the Union or for the United Kingdom until the date either the Union or the United Kingdom has notified a new member. Rule 3 Meetings 1. Each meeting of the Partnership Council shall be convened by the Secretariat at a date and time agreed by the co-chairs. Where the Union or the United Kingdom has transmitted a request for a meeting through the Secretariat, the Partnership Council shall endeavour to meet within 30 days of such request, or sooner in cases provided for in this Agreement. 2. The Partnership Council shall hold its meetings alternately in Brussels and London, unless the co-chairs decide otherwise. 3. By way of derogation from paragraph 2, the co-chairs may agree that a meeting of the Partnership Council be held by videoconference or teleconference. Rule 4 Participation in meetings 1. A reasonable period of time in advance of each meeting, the Union and the United Kingdom shall inform each other through the Secretariat of the intended composition of their respective delegations and shall specify the name and function of each member of the delegation. 2. Where appropriate the co-chairs may, by mutual consent, invite experts (i.e. non-government officials) to attend meetings of the Partnership Council in order to provide information on a specific subject and only for the parts of the meeting where such specific subjects are discussed. Rule 5 Documents Written documents on which the deliberations of the Partnership Council are based shall be numbered and circulated to the Union and the United Kingdom by the Secretariat. Rule 6 Correspondence 1. The Union and the United Kingdom shall send their correspondence addressed to the Partnership Council via the Secretariat. Such correspondence may be sent in any form of written communication, including by electronic mail. 2. The Secretariat shall ensure that correspondence addressed to the Partnership Council is delivered to the co-chairs and is circulated, where appropriate, in accordance with Rule 5. 3. All correspondence from, or addressed directly to, the co-chairs shall be forwarded to the Secretariat and shall be circulated, where appropriate, in accordance with Rule 5. Rule 7 Agenda for the meetings 1. For each meeting, a draft provisional agenda shall be drawn up by the Secretariat. It shall be transmitted, together with the relevant documents, to the co-chairs no later than 10 days before the date of the meeting. 2. The provisional agenda shall include items requested by the Union or the United Kingdom. Any such request, together with any relevant document, shall be submitted to the Secretariat no later than 15 days before the beginning of the meeting. 3. No later than 5 days before the date of the meeting, the co-chairs shall decide on the provisional agenda for a meeting. 4. The agenda shall be adopted by the Partnership Council at the beginning of each meeting. On request by the Union or the United Kingdom, an item other than those included in the provisional agenda may be included in the agenda by consensus. 5. The co-chairs may, by mutual consent, reduce or increase the time periods specified in paragraphs 1, 2 and 3 in order to take account of the requirements of a particular case. Rule 8 Minutes 1. Draft minutes of each meeting shall be drawn up by the official acting as member of the Secretariat of the Party hosting the meeting, within 15 days from the end of the meeting, unless otherwise decided by the co-chairs. The draft minutes shall be transmitted for comments to the member of the Secretariat of the other Party. The latter may submit comments within 7 days from the date of receipt of the draft minutes. 2. The minutes shall, as a rule, summarise each item on the agenda, specifying where applicable: (a) the documents submitted to the Partnership Council; (b) any statement that one of the co-chairs requested to be entered in the minutes; and (c) the decisions taken, recommendations made, statements agreed upon and conclusions adopted on specific items. 3. The minutes shall include as an annex a list of participants setting out for each of the delegations the names and functions of all individuals who attended the meeting. 4. The Secretariat shall adjust the draft minutes on the basis of comments received and the draft minutes, as revised, shall be approved by the co-chairs within 28 days of the date of the meeting, or by any other date agreed by the co-chairs. Once approved, two versions of the minutes shall be authenticated by signature of the members of the Secretariat. The Union and the United Kingdom shall each receive one of these authentic versions. The co-chairs may agree that signing and exchanging electronic copies satisfies this requirement. Rule 9 Decisions and Recommendations 1. In the period between meetings, the Partnership Council may adopt decisions or recommendations by written procedure. The text of a draft decision or recommendation shall be presented in writing by a co-chair to the other co-chair in the working language of the Partnership Council. The other Party shall have one month, or any longer period of time specified by the proposing Party, to express its agreement to the draft decision or recommendation. If the other Party does not express its agreement, the proposed decision or recommendation shall be discussed and may be adopted at the next meeting of the Partnership Council. The draft decisions or recommendations shall be deemed to be adopted once the other Party expresses its agreement and shall be recorded in the minutes of the next meeting of the Partnership Council pursuant to Rule 8. 2. Where the Partnership Council adopts decisions or recommendations, the words \"Decision\" or \"Recommendation\", respectively, shall be inserted in the title of such acts. The Secretariat shall record any decision or recommendation under a serial number and with a reference to the date of its adoption. 3. Decisions adopted by the Partnership Council shall specify the date on which they take effect. 4. Decisions and recommendations adopted by the Partnership Council shall be established in duplicate in the authentic languages and signed by the co-chairs and shall be sent by the Secretariat to the Union and the United Kingdom immediately after signature. The co-chairs may agree that signing and exchanging electronic copies satisfies the requirement for signature. Rule 10 Transparency 1. The co-chairs may agree that the Partnership Council shall meet in public. 2. Each Party may decide on the publication of the decisions and recommendations of the Partnership Council in its respective official journal or online. 3. If the Union or the United Kingdom submits information that is confidential or protected from disclosure under its laws and regulations to the Partnership Council, the other party shall treat that information received as confidential. 4. Provisional agendas of the meetings shall be made public before the meeting of the Partnership Council takes place. The minutes of the meetings shall be made public following their approval in accordance with Rule 8. 5. Publication of documents referred to in paragraphs 2, 3 and 4 shall be made in compliance with both Parties\u2019 applicable data protection rules. Rule 11 Languages 1. The official languages of the Partnership Council shall be the official languages of the Union and the United Kingdom. 2. The working language of the Partnership Council shall be English. Unless otherwise decided by the co-chairs, the Partnership Council shall base its deliberations on documents prepared in English. 3. The Partnership Council shall adopt decisions concerning the amendment or interpretation of this Agreement in the languages of the authentic texts of this Agreement. All other decisions of the Partnership Council, including the ones through which the present rules of procedure are amended, shall be adopted in the working language referred to in paragraph 2. Rule 12 Expenses 1. The Union and the United Kingdom shall each meet any expenses they incur as a result of participating in the meetings of the Partnership Council. 2. Expenditure in connection with the organisation of meetings and reproduction of documents shall be borne by the party hosting the meeting. 3. Expenditure in connection with interpretation to and from the working language of the Partnership Council at meetings shall be borne by the party requesting such interpretation. 4. Each Party shall be responsible for the translation of decisions and other documents into its own official language(s), if required pursuant to Rule 11, and it shall meet expenditures associated with such translations. Rule 13 Committees 1. Without prejudice to paragraph 2 of this Rule, Rules 1 to 12 shall apply mutatis mutandis to the Committees. 2. The Committees shall inform the Partnership Council of their meeting schedules and agenda sufficiently in advance of their meetings, and shall report to the Partnership Council on the results and conclusions of each of their meetings. ANNEX 2 INTRODUCTORY NOTES TO PRODUCT-SPECIFIC RULES OF ORIGIN NOTE 1 General principles 1. This Annex sets out the general rules for the applicable requirements of Annex 3 as provided for in point (c) of Article 39(1) of this Agreement. 2. For the purposes of this Annex and Annex 3, the requirements for a product to be originating in accordance with point (c) of Article 39(1) of this Agreement are a change in tariff classification, a production process, a maximum value or weight of non-originating materials, or any other requirement specified in this Annex and Annex 3. 3. Reference to weight in a product-specific rule of origin means the net weight, which is the weight of a material or a product, not including the weight of any packaging. 4. This Annex and Annex 3 are based on the Harmonised System, as amended on 1 January 2017. NOTE 2 The structure of the list of product-specific rules of origin 1. Notes on sections or Chapters, where applicable, are read in conjunction with the product-specific rules of origin for the relevant section, Chapter, heading or subheading. 2. Each product-specific rule of origin set out in Column 2 of Annex 3 applies to the corresponding product indicated in Column 1 of Annex 3. 3. If a product is subject to alternative product-specific rules of origin, the product shall be originating in a Party if it satisfies one of the alternatives. 4. If a product is subject to a product-specific rule of origin that includes multiple requirements, the product shall be originating in a Party only if it satisfies all of the requirements. 5. For the purposes of this Annex and Annex 3, the following definitions apply: (a) \"section\" means a section of the Harmonised System; (b) \"Chapter\" means the first two-digits in the tariff classification number under the Harmonised System; (c) \"heading\" means the first four-digits in the tariff classification number under the Harmonised System; and (d) \"subheading\" means the first six-digits in the tariff classification number under the Harmonised System. 6. For the purposes of the product-specific rules of origin, the following abbreviations apply: \"CC\" means production from non-originating materials of any Chapter, except that of the product; this means that any non-originating material used in the production of the product must be classified under a Chapter (2-digit level of the Harmonised System) other than that of the product (i.e. a change in Chapter); \"CTH\" means production from non-originating materials of any heading, except that of the product; this means that any non-originating material used in the production of the product must be classified under a heading (4-digit level of the Harmonised System) other than that of the product (i.e. a change in heading); \"CTSH\" means production from non-originating materials of any subheading, except that of the product; this means that any non-originating material used in the production of the product must be classified under a subheading (6-digit level of the Harmonised System) other than that of the product (i.e. a change in subheading). NOTE 3 Application of the product-specific rules of origin 1. Article 39 of this Agreement, concerning products having acquired originating status which are used in the production of other products, applies whether or not this status has been acquired inside the same factory in a Party where these products are used. 2. If a product-specific rule of origin specifically excludes certain non-originating material or provides that the value or weight of a specified non-originating material shall not exceed a specific threshold, these conditions do not apply to non-originating materials classified elsewhere in the Harmonised System. Example 1: when the rule for bulldozers (subheading 8429.11) requires: \"CTH except from non-originating materials of heading 84.31\", the use of non-originating materials classified elsewhere than 84.29 and 84.31- such as screws (HS heading 73.18), insulated wires and electric conductors (heading 85.44) and various electronics (Chapter 85) - is not limited. Example 2: When the rule for heading 35.05 (dextrins and other modified starches; glues based on starches etc) requires \"CTH except from non-originating materials of heading 11.08\" then the use of non-originating materials classified elsewhere than 11.08 (starches, inulin), such as materials of Chapter 10 (cereals), is not limited. 3. If a product-specific rule of origin provides that a product shall be produced from a particular material, this does not prevent the use of other materials which are unable to satisfy that rule because of their inherent nature. NOTE 4 Calculation of a maximum value of non-originating materials For the purposes of the product-specific rules of origin, the following definitions apply: (a) \"customs value\" means the value as determined in accordance with the Agreement on Implementation of Article VII of GATT 1994; (b) \"EXW\" or \"ex-works price\" means: (i) the price of the product paid or payable to the producer in whose undertaking the last working or processing is carried out, provided that the price includes the value of all the materials used and all other costs incurred in the production of the product, minus any internal taxes which are, or may be, repaid when the product obtained is exported; or (ii) if there is no price paid or payable or if the actual price paid does not reflect all costs related to the production of the product which are actually incurred in the production of the product, the value of all the materials used and all other costs incurred in the production of the product in the exporting Party: (A) including selling, general and administrative expenses, as well as profit, that can reasonably be allocated to the product; and (B) excluding the cost of freight, insurance, all other costs incurred in transporting the product and any internal taxes of the exporting Party which are, or may be, repaid when the product obtained is exported; (iii) for the purposes of point (i), where the last production has been contracted to a producer, the term \"producer\" in point (i) refers to the person who has employed the subcontractor. (c) \"MaxNOM\" means the maximum value of non-originating materials expressed as a percentage and shall be calculated according to the following formula: (d) \"VNM\" means the value of the non-originating materials used in the production of the product which is its customs value at the time of importation including freight, insurance if appropriate, packing and all other costs incurred in transporting the materials to the importation port in the Party where the producer of the product is located; where the value of the non-originating materials is not known and cannot be ascertained, the first ascertainable price paid for the non-originating materials in the Union or in the United Kingdom is used; the value of the non-originating materials used in the production of the product may be calculated on the basis of the weighted average value formula or other inventory valuation method under accounting principles which are generally accepted in the Party. NOTE 5 Definitions of processes referred to in Sections V to VII of Annex 3 For the purposes of product-specific rules of origin, the following definitions apply: (a) \"biotechnological processing\" means: (i) biological or biotechnological culturing (including cell culture), hybridisation or genetic modification of micro-organisms (bacteria, viruses (including phages) etc.) or human, animal or plant cells; and (ii) production, isolation or purification of cellular or intercellular structures (such as isolated genes, gene fragments and plasmids), or fermentation; (b) \"change in particle size\" means the deliberate and controlled modification in particle size of a product, other than by merely crushing or pressing, resulting in a product with a defined particle size, defined particle size distribution or defined surface area, which is relevant to the purposes of the resulting product and with physical or chemical characteristics different from those of the input materials; (c) \"chemical reaction\" means a process (including a biochemical processing) which results in a molecule with a new structure by breaking intramolecular bonds and by forming new intramolecular bonds, or by altering the spatial arrangement of atoms in a molecule, with the exception of the following, which are not considered to be chemical reactions for the purpose of this definition: (i) dissolving in water or other solvents; (ii) the elimination of solvents including solvent water; or (iii) the addition or elimination of water of crystallisation; (d) \"distillation\" means: (i) atmospheric distillation: a separation process in which petroleum oils are converted, in a distillation tower, into fractions according to boiling point and the vapour then condensed into different liquefied fractions; products produced from petroleum distillation may include liquefied petroleum gas, naphtha, gasoline, kerosene, diesel or heating oil, light gas oils and lubricating oil; and (ii) vacuum distillation: distillation at a pressure below atmospheric but not so low that it would be classed as molecular distillation; vacuum distillation is used for distilling high-boiling and heat-sensitive materials such as heavy distillates in petroleum oils to produce light to heavy vacuum gas oils and residuum; (e) \"isomer separation\" means the isolation or separation of isomers from a mixture of isomers; (f) \"mixing and blending\" means the deliberate and proportionally controlled mixing or blending (including dispersing) of materials, other than the addition of diluents, only to conform to predetermined specifications which results in the production of a product having physical or chemical characteristics that are relevant to the purposes or uses of the product and are different from the input materials; (g) \"production of standard materials\" (including standard solutions) means a production of a preparation suitable for analytical, calibrating or referencing uses with precise degrees of purity or proportions certified by the producer; and (h) \"purification\" means a process which results in the elimination of at least 80 % of the content of existing impurities or the reduction or elimination of impurities resulting in a good suitable for one or more of the following applications: (i) pharmaceutical, medical, cosmetic, veterinary or food grade substances; (ii) chemical products and reagents for analytical, diagnostic or laboratory uses; (iii) elements and components for use in micro-electronics; (iv) specialised optical uses; (v) biotechnical use, for example, in cell culturing, in genetic technology or as a catalyst; (vi) carriers used in a separation process; or (vii) nuclear grade uses. NOTE 6 Definitions of terms used in Section XI of Annex 3 For the purposes of the product-specific rules of origin, the following definitions apply: (a) \"man-made staple fibres\" means synthetic or artificial filament tow, staple fibres or waste, of headings 55.01 to 55.07; (b) \"natural fibres\" means fibres other than synthetic or artificial fibres, the use of which is restricted to the stages before spinning takes place, including waste, and, unless otherwise specified, includes fibres which have been carded, combed or otherwise processed, but not spun; \"natural fibres\" includes horsehair of heading 05.11, silk of headings 50.02 and 50.03, wool-fibres and fine or coarse animal hair of headings 51.01 to 51.05, cotton fibres of headings 52.01 to 52.03, and other vegetable fibres of headings 53.01 to 53.05; (c) \"printing\" means a technique by which an objectively assessed function, such as colour, design, or technical performance, is given to a textile substrate with a permanent character, using screen, roller, digital or transfer techniques; and (d) \"printing (as standalone operation)\" means a technique by which an objectively assessed function, such as colour, design, or technical performance, is given to a textile substrate with a permanent character, using screen, roller, digital or transfer techniques combined with at least two preparatory or finishing operations (such as scouring, bleaching, mercerizing, heat setting, raising, calendaring, shrink resistance processing, permanent finishing, decatising, impregnating, mending and burling, shearing, singeing, process of air-tumbler, process of stenter, milling, steam and shrinking, and wet decatising), provided that the value of all the non-originating materials used does not exceed 50 % of the EXW of the product. NOTE 7 Tolerances applicable to products containing two or more basic textile materials 1. For the purposes of this Note, basic textile materials are the following: (a) silk; (b) wool; (c) coarse animal hair; (d) fine animal hair; (e) horsehair; (f) cotton; (g) paper-making materials and paper; (h) flax; (i) true hemp; (j) jute and other textile bast fibres; (k) sisal and other textile fibres of the genus Agave; (l) coconut, abaca, ramie and other vegetable textile fibres; (m) synthetic man-made filaments; (n) artificial man-made filaments; (o) current-conducting filaments; (p) synthetic man-made staple fibres of polypropylene; (q) synthetic man-made staple fibres of polyester; (r) synthetic man-made staple fibres of polyamide; (s) synthetic man-made staple fibres of polyacrylonitrile; (t) synthetic man-made staple fibres of polyimide; (u) synthetic man-made staple fibres of polytetrafluoroethylene; (v) synthetic man-made staple fibres of poly (phenylene sulphide); (w) synthetic man-made staple fibres of poly (vinyl chloride); (x) other synthetic man-made staple fibres; (y) artificial man-made staple fibres of viscose; (z) other artificial man-made staple fibres; (aa) yarn made of polyurethane segmented with flexible segments of polyether, whether or not gimped; (bb) yarn made of polyurethane segmented with flexible segments of polyester whether or not gimped; (cc) products of heading 56.05 (metallised yarn) incorporating strip consisting of a core of aluminium foil or of a core of plastic film irrespective of whether or not coated with aluminium powder, of a width not exceeding 5 mm, sandwiched by means of a transparent or coloured adhesive between two layers of plastic film; (dd) other products of heading 56.05; (ee) glass fibres; and (ff) metal fibres. 2. Where reference to this Note is made in Annex 3, the requirements set out in its Column 2 shall not apply, as a tolerance, to non-originating basic textile materials which are used in the production of a product, provided that: (a) the product contains two or more basic textile materials; and (b) the weight of the non-originating basic textile materials, taken together, does not exceed 10 % of the total weight of all the basic textile materials used. Example: For a woollen fabric of heading 51.12 containing woollen yarn of heading 51.07, synthetic yarn of staple fibres of heading 55.09 and materials other than basic textile materials, non-originating woollen yarn which does not satisfy the requirement set out in Annex 3, or non-originating synthetic yarn which does not satisfy the requirement set out in Annex 3, or a combination of both, may be used, provided that their total weight does not exceed 10 % of the weight of all the basic textile materials. 3. Notwithstanding point (b) of paragraph 2, for products containing \"yarn made of polyurethane segmented with flexible segments of polyether, whether or not gimped\", the maximum tolerance is 20 %. However, the percentage of the other non-originating basic textile materials shall not exceed 10 %. 4. Notwithstanding point (b) of paragraph 2, for products containing \"strip consisting of a core of aluminium foil or of a core of plastic film irrespective of whether or not coated with aluminium powder, of a width not exceeding 5 mm, sandwiched by means of a transparent or coloured adhesive between two layers of plastic film\", the maximum tolerance is 30 %. However, the percentage of the other non-originating basic textile materials shall not exceed 10 %. NOTE 8 Other tolerances applicable to certain textile products 1. Where reference to this Note is made in Annex 3, non-originating textile materials (with the exception of linings and interlinings) which do not satisfy the requirements set out in its Column 2 for a made-up textile product may be used, provided that they are classified under a heading other than that of the product and that their value does not exceed 8 % of the EXW of the product. 2. Non-originating materials which are not classified under Chapters 50 to 63 may be used without restriction in the production of textile products classified under Chapters 50 to 63, whether or not they contain textiles. Example: If a requirement set out in Annex 3 provides that yarn shall be used, for a certain textile item (such as trousers), this does not prevent the use of non-originating metal items (such as buttons), because metal items are not classified under Chapters 50 to 63. For the same reasons, it does not prevent the use of non-originating slide fasteners, even though slide-fasteners normally contain textiles. 3. Where a requirement set out in Annex 3 consists in a maximum value of non-originating materials, the value of the non-originating materials which are not classified under Chapters 50 to 63 shall be taken into account in the calculation of the value of the non-originating materials. NOTE 9 Agricultural products Agricultural products classified under Section II of the Harmonised System and heading 24.01, which are grown or harvested in the territory of a Party, shall be treated as originating in the territory of that Party, even if grown from seeds, bulbs, rootstock, cuttings, slips, grafts, shoots, buds, or other live parts of plants imported from a third country. ANNEX 3 PRODUCT-SPECIFIC RULES OF ORIGIN Column 1 Harmonised System classification (2017) including specific description Column 2 Product-specific rule of origin SECTION I LIVE ANIMALS; ANIMAL PRODUCTS Chapter 1 Live animals 01.01-01.06 All animals of Chapter 1 are wholly obtained. Chapter 2 Meat and edible meat offal 02.01-02.10 Production in which all the materials of Chapters 1 and 2 used are wholly obtained. Chapter 3 Fish and crustaceans, molluscs and other aquatic invertebrates 03.01-03.08 Production in which all the materials of Chapter 3 used are wholly obtained. Chapter 4 Dairy produce; birds' eggs; natural honey; edible products of animal origin, not elsewhere specified or included 04.01-04.10 Production in which: \u2014 all the materials of Chapter 4 used are wholly obtained; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 does not exceed 20 % of the weight of the product. Chapter 5 Products of animal origin, not elsewhere specified or included 05.01-05.11 Production from non-originating materials of any heading. SECTION II VEGETABLE PRODUCTS Chapter 6 Live trees and other plants; bulbs, roots and the like; cut flowers and ornamental foliage 06.01-06.04 Production in which all the materials of Chapter 6 used are wholly obtained. Chapter 7 Edible vegetables and certain roots and tubers 07.01-07.14 Production in which all the materials of Chapter 7 used are wholly obtained. Chapter 8 Edible fruit and nuts; peel of citrus fruit or melons 08.01-08.14 Production in which: \u2014 all the materials of Chapter 8 used are wholly obtained; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 does not exceed 20 % of the weight of the product. Chapter 9 Coffee, tea, mat\u00e9 and spices 09.01-09.10 Production from non-originating materials of any heading. Chapter 10 Cereals 10.01-10.08 Production in which all the materials of Chapter 10 used are wholly obtained. Chapter 11 Products of the milling industry; malt; starches; inulin; wheat gluten 11.01-11.09 Production in which all materials of Chapters 10 and 11, headings 07.01, 07.14, 23.02 to 23.03 or subheading 0710.10 used are wholly obtained. Chapter 12 Oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruit; industrial or medicinal plants; straw and fodder 12.01-12.14 CTH Chapter 13 Lac; gums, resins and other vegetable saps and extracts 13.01-13.02 Production from non-originating materials of any heading in which the total weight of non-originating materials of headings 17.01 and 17.02 does not exceed 20 % of the weight of the product. Chapter 14 Vegetable plaiting materials; vegetable products not elsewhere specified or included 14.01-14.04 Production from non-originating materials of any heading. SECTION III ANIMAL OR VEGETABLE FATS AND OILS AND THEIR CLEAVAGE PRODUCTS; PREPARED EDIBLE FATS; ANIMAL OR VEGETABLE WAXES Chapter 15 Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes 15.01-15.04 CTH 15.05-15.06 Production from non-originating materials of any heading. 15.07-15.08 CTSH 15.09-15.10 Production in which all the vegetable materials used are wholly obtained. 15.11-15.15 CTSH 15.16-15.17 CTH 15.18-15.19 CTSH 15.20 Production from non-originating materials of any heading. 15.21-15.22 CTSH SECTION IV PREPARED FOODSTUFFS; BEVERAGES, SPIRITS AND VINEGAR; TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES Chapter 16 Preparations of meat, of fish or of crustaceans, molluscs or other aquatic invertebrates 1601.00-1604.18 Production in which all the materials of Chapters 1, 2, 3 and 16 used are wholly obtained (1). 1604.19 CC 1604.20 \u2014 Preparations of surimi: CC \u2014 Others: Production in which all the materials of Chapters 3 and 16 used are wholly obtained (2). 1604.31-1605.69 Production in which all the materials of Chapters 3 and 16 used are wholly obtained. Chapter 17 Sugars and sugar confectionery 17.01 CTH 17.02 CTH, provided that the total weight of non-originating materials of headings 11.01 to 11.08, 17.01 and 17.03 used does not exceed 20 % of the weight of the product. 17.03 CTH 17.04 \u2014 White chocolate: CTH, provided that: (a) all the materials of Chapter 4 used are wholly obtained; and (b) (i) the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product; or (ii) the value of non-originating materials of headings 17.01 and 17.02 used does not exceed 30 % of the ex-works price of the product. \u2014 Others: CTH, provided that: \u2014 all the materials of Chapter 4 used are wholly obtained; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product. Chapter 18 Cocoa and cocoa preparations 18.01-18.05 CTH 1806.10 CTH, provided that: \u2014 all the materials of Chapter 4 used are wholly obtained; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product. 1806.20-1806.90 CTH, provided that: (a) all the materials of Chapter 4 used are wholly obtained; and (b) (i) the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product; or (ii) the value of non-originating materials of headings 17.01 and 17.02 used does not exceed 30 % of the ex-works price of the product. Chapter 19 Preparations of cereals, flour, starch or milk; pastrycooks' products 19.01-19.05 CTH, provided that: \u2014 all the materials of Chapter 4 used are wholly obtained; \u2014 the total weight of non-originating materials of Chapters 2, 3 and 16 used does not exceed 20 % of the weight of the product; \u2014 the total weight of non-originating materials of headings 10.06 and 11.08 used does not exceed 20 % of the weight of the product; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product. Chapter 20 Preparations of vegetables, fruit, nuts or other parts of plants 20.01 CTH 20.02-20.03 Production in which all the materials of Chapter 7 used are wholly obtained. 20.04-20.09 CTH, provided that the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product. Chapter 21 Miscellaneous edible preparations 21.01-21.02 CTH, provided that: \u2014 all the materials of Chapter 4 used are wholly obtained; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 20 % of the weight of the product. 2103.10 2103.20 2103.90 CTH; however, non-originating mustard flour or meal or prepared mustard may be used. 2103.30 Production from non-originating materials of any heading. 21.04-21.06 CTH, provided that: \u2014 all the materials of Chapter 4 used are wholly obtained; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 20 % of the weight of the product. Chapter 22 Beverages, spirits and vinegar 22.01-22.06 CTH except from non-originating materials of headings 22.07 and 22.08, provided that: \u2014 all the materials of subheadings 0806.10, 2009.61, 2009.69 used are wholly obtained; \u2014 all the materials of Chapter 4 used are wholly obtained; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 20 % of the weight of the product. 22.07 CTH except from non-originating materials of heading 22.08, provided that all the materials of Chapter 10, subheadings 0806.10, 2009.61 and 2009.69 used are wholly obtained. 22.08-22.09 CTH except from non-originating materials of headings 22.07 and 22.08, provided that all the materials of subheadings 0806.10, 2009.61 and 2009.69 used are wholly obtained. Chapter 23 Residues and waste from the food industries; prepared animal fodder 23.01 CTH 2302.10-2303.10 CTH, provided that the total weight of non-originating materials of Chapter 10 used does not exceed 20 % of the weight of the product. 2303.20-2308.00 CTH 23.09 CTH, provided that: \u2014 all the materials of Chapters 2 and 4 used are wholly obtained; \u2014 the total weight of non-originating materials of headings 10.01 to 10.04, 10.07 to 10.08, Chapter 11, and headings 23.02 and 23.03 used does not exceed 20 % of the weight of the product; and \u2014 the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 20 % of the weight of the product. Chapter 24 Tobacco and manufactured tobacco substitutes 24.01 Production in which all materials of heading 24.01 are wholly obtained. 2402.10 Production from non-originating materials of any heading, provided that the total weight of non-originating materials of heading 24.01 used does not exceed 30 % of the weight of materials of Chapter 24 used. 2402.20 Production from non-originating materials of any heading, except that of the product and of smoking tobacco of subheading 2403.19, and in which at least 10 % by weight of all materials of heading 24.01 used is wholly obtained. 2402.90 Production from non-originating materials of any heading, provided that the total weight of non-originating materials of heading 24.01 used does not exceed 30 % of the weight of materials of Chapter 24 used. 24.03 CTH, in which at least 10 % by weight of all materials of heading 24.01 used are wholly obtained. SECTION V MINERAL PRODUCTS Section note: For definitions of horizontal processing rules within this Section, see Note 5 of Annex 2 Chapter 25 Salt; sulphur; earths and stone; plastering materials, lime and cement 25.01-25.30 CTH; or MaxNOM 70 % (EXW). Chapter 26 Ores, slag and ash 26.01-26.21 CTH Chapter 27 Mineral fuels, mineral oils and products of their distillation; bituminous substances; mineral waxes 27.01-27.09 Production from non-originating materials of any heading. 27.10 CTH except from non-originating biodiesel of subheading 3824.99 or 3826.00; or Distillation or a chemical reaction is undergone, provided that biodiesel (including hydrotreated vegetable oil) of heading 27.10 and subheadings 3824.99 and 3826.00 used is obtained by esterification, transesterification or hydrotreatment. 27.11-27.15 Production from non-originating materials of any heading. SECTION VI PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES Section note: For definitions of horizontal processing rules within this Section, see Note 5 of Annex 2 Chapter 28 Inorganic chemicals; organic or inorganic compounds of precious metals, of rare-earth metals, of radioactive elements or of isotopes 28.01-28.53 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 29 Organic chemicals 2901.10-2905.42 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 2905.43-2905.44 CTH except from non-originating materials of heading 17.02 and subheading 3824.60. 2905.45 CTSH, however, non-originating materials of the same subheading as the product may be used, provided that their total value does not exceed 20 % of the ex-works price of the product; or MaxNOM 50 % (EXW). 2905.49-2942 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 30 Pharmaceutical products 30.01-30.06 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 31 Fertilisers 31.01-31.04 CTH, however, non-originating materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the EXW of the product; or MaxNOM 40 % (EXW). 31.05 \u2014 Sodium nitrate \u2014 Calcium cyanamide \u2014 Potassium sulphate \u2014 Magnesium potassium sulphate CTH, however, non-originating materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the EXW of the product; or MaxNOM 40 % (EXW). -Others CTH, however, non-originating materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the EXW of the product, and in which the value of all non-originating materials used does not exceed 50 % of the EXW of the product; or MaxNOM 40 % (EXW). Chapter 32 Tanning or dyeing extracts; tannins and their derivatives; dyes, pigments and other colouring matter; paints and varnishes; putty and other mastics; inks 32.01-32.15 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 33 Essential oils and resinoids; perfumery, cosmetic or toilet preparations 33.01 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 3302.10 CTH, however, non-originating materials of subheading 3302.10 may be used, provided that their total value does not exceed 20 % of the EXW of the product. 3302.90 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 33.03 Production from non-originating materials of any heading. 33.04 -33.07 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 34 Soap, organic surface-active agents, washing preparations, lubricating preparations, artificial waxes, prepared waxes, polishing or scouring preparations, candles and similar articles, modelling pastes, \"dental waxes\" and dental preparations with a basis of plaster 34.01-34.07 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 35 Albuminoidal substances; modified starches; glues; enzymes 35.01-35.04 CTH except from non-originating materials of Chapter 4. 35.05 CTH except from non-originating materials of heading 11.08. 35.06-35.07 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 36 Explosives; pyrotechnic products; matches; pyrophoric alloys; certain combustible preparations 36.01-36.06 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 37 Photographic or cinematographic goods 37.01-37.07 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 38 Miscellaneous chemical products 38.01-38.08 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 3809.10 CTH except from non-originating materials of headings 11.08 and 35.05. 3809.91-3822.00 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 38.23 Production from non-originating material of any heading. 3824.10-3824.50 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 3824.60 CTH except from non-originating materials of subheadings 2905.43 and 2905.44. 3824.71-3825.90 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 38.26 Production in which biodiesel is obtained through transesterification, esterification or hydro-treatment. SECTION VII PLASTICS AND ARTICLES THEREOF; RUBBER AND ARTICLES THEREOF Section note: For definitions of horizontal processing rules within this Section, see Note 5 of Annex 2 Chapter 39 Plastics and articles thereof 39.01-39.15 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 39.16-39.19 CTH; or MaxNOM 50 % (EXW). 39.20 CTSH; or MaxNOM 50 % (EXW). 39.21-39.22 CTH; or MaxNOM 50 % (EXW). 3923.10-3923.50 CTSH; or MaxNOM 50 % (EXW). 3923.90-3925.90 CTH; or MaxNOM 50 % (EXW). 39.26 CTSH; or MaxNOM 50 % (EXW). Chapter 40 Rubber and articles thereof 40.01-40.11 CTH; or MaxNOM 50 % (EXW). 4012.11-4012.19 CTSH; or Retreading of used tyres. 4012.20-4017.00 CTH; or MaxNOM 50 % (EXW). SECTION VIII RAW HIDES AND SKINS, LEATHER, FURSKINS AND ARTICLES THEREOF; SADDLERY AND HARNESS; TRAVEL GOODS, HANDBAGS AND SIMILAR CONTAINERS; ARTICLE OF ANIMAL GUT (OTHER THAN SILK-WORM GUT) Chapter 41 Raw hides and skins (other than furskins) and leather 41.01-4104.19 CTH 4104.41-4104.49 CTSH except from non-originating materials of subheadings 4104.41 to 4104.49. 4105.10 CTH 4105.30 CTSH 4106.21 CTH 4106.22 CTSH 4106.31 CTH 4106.32-4106.40 CTSH 4106.91 CTH 4106.92 CTSH 41.07-41.13 CTH except from non-originating materials of subheadings 4104.41, 4104.49, 4105.30, 4106.22, 4106.32 and 4106.92. However, non-originating materials of subheadings 4104.41, 4104.49, 4105.30, 4106.22, 4106.32 or 4106.92 may be used provided that they undergo a retanning operation. 4114.10 CTH 4114.20 CTH except from non-originating materials of subheadings 4104.41, 4104.49, 4105.30, 4106.22, 4106.32, 4106.92 and 4107. However, non-originating materials of subheadings 4104.41, 4104.49, 4105.30, 4106.22, 4106.32, 4106.92 and heading 41.07 may be used provided that they undergo a retanning operation. 41.15 CTH Chapter 42 Articles of leather; saddlery and harness; travel goods, handbags and similar containers; articles of animal gut (other than silk-worm gut) 42.01-42.06 CTH; or MaxNOM 50 % (EXW). Chapter 43 Furskins and artificial fur; manufactures thereof 4301.10-4302.20 CTH; or MaxNOM 50 % (EXW). 4302.30 CTSH 43.03-43.04 CTH; or MaxNOM 50 % (EXW). SECTION IX WOOD AND ARTICLES OF WOOD; WOOD CHARCOAL; CORK AND ARTICLES OF CORK; MANUFACTURES OF STRAW, OF ESPARTO OR OTHER PLAITING MATERIALS; BASKETWARE AND WICKERWORK Chapter 44 Wood and articles of wood; wood charcoal 44.01-44.21 CTH; or MaxNOM 50 % (EXW). Chapter 45 Cork and articles of cork 45.01-45.04 CTH; or MaxNOM 50 % (EXW). Chapter 46 Manufactures of straw, of esparto or of other plaiting materials; basketware and wickerwork 46.01-46.02 CTH; or MaxNOM 50 % (EXW). SECTION X PULP OF WOOD OR OF OTHER FIBROUS CELLULOSIC MATERIAL; RECOVERED (WASTE AND SCRAP) PAPAER OR PAPERBOARD; PAPER AND PAPERBOARD AND ARTICLES THEREOF Chapter 47 Pulp of wood or of other fibrous cellulosic material; recovered (waste and scrap) paper or paperboard 47.01-47.07 CTH; or MaxNOM 50 % (EXW). Chapter 48 Paper and paperboard; articles of paper pulp, of paper or of paperboard 48.01-48.23 CTH; or MaxNOM 50 % (EXW). Chapter 49 Printed books, newspapers, pictures and other products of the printing industry; manuscripts, typescripts and plans 49.01-49.11 CTH; or MaxNOM 50 % (EXW). SECTION XI TEXTILES AND TEXTILE ARTICLES Section note: For definitions of terms used for tolerances applicable to certain products made of textile materials, see Notes 6,7 and 8 of Annex 2 Chapter 50 Silk 50.01-50.02 CTH 50.03 \u2014 Carded or combed: Carding or combing of silk waste. \u2014 Others: CTH 50.04-50.05 Spinning of natural fibres; Extrusion of man-made continuous filament combined with spinning; Extrusion of man-made continuous filament combined with twisting; or Twisting combined with any mechanical operation. 50.06 \u2014 Silk yarn and yarn spun from silk waste: Spinning of natural fibres; Extrusion of man-made continuous filament combined with spinning; Extrusion of man-made continuous filament combined with twisting; or Twisting combined with any mechanical operation. \u2014 Silk-worm gut: CTH 50.07 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Twisting or any mechanical operation combined with weaving; Weaving combined with dyeing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 51 Wool, fine or coarse animal hair; horsehair yarn and woven fabric 51.01-51.05 CTH 51.06-51.10 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 51.11-51.13 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Weaving combined with dyeing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 52 Cotton 52.01-52.03 CTH 52.04-52.07 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 52.08-52.12 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Twisting or any mechanical operation combined with weaving; Weaving combined with dyeing or with coating or with laminating; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 53 Other vegetable textile fibres; paper yarn and woven fabrics of paper yarn 53.01-53.05 CTH 53.06-53.08 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 53.09-53.11 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Weaving combined with dyeing or with coating or with laminating; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 54 Man-made filaments; strip and the like of man-made textile materials 54.01-54.06 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 54.07-54.08 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Yarn dyeing combined with weaving; Weaving combined with dyeing or with coating or with laminating; Twisting or any mechanical operation combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 55 Man-made staple fibres 55.01-55.07 Extrusion of man-made fibres. 55.08-55.11 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 55.12-55.16 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Twisting or any mechanical operation combined with weaving; Weaving combined with dyeing or with coating or with laminating; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 56 Wadding, felt and nonwovens; special yarns; twine, cordage, ropes and cables and articles thereof 56.01 Spinning or bonding of natural fibres; Extrusion of man-made fibres combined with spinning or bonding; Flocking combined with dyeing or with printing; or Coating, flocking, laminating, or metalizing combined with at least two other main preparatory or finishing operations (such as calendering, shrink-resistance processes, heat setting, permanent finishing), provided that the value of non-originating materials used does not exceed 50 % of the EXW of the product. 56.02 \u2014 Needleloom Felt: Extrusion of man-made fibres combined with fabric formation; however: \u2014 non-originating polypropylene filament of heading 54.02; \u2014 non-originating polypropylene fibres of heading 55.03 or 55.06; or \u2014 non-originating polypropylene filament tow of heading 55.01; of which the denomination in all cases of a single filament or fibre is less than 9 decitex, may be used, provided that their total value does not exceed 40 % of the EXW of the product; or Non-woven fabric formation alone in the case of felt made from natural fibres. \u2014 Others: Extrusion of man-made fibres combined with fabric formation; or Non-woven fabric formation alone in the case of other felt made from natural fibres. 5603.11-5603.14 Production from \u2014 directionally or randomly oriented filaments; or \u2014 substances or polymers of natural or man-made origin; followed in both cases by bonding into a nonwoven. 5603.91-5603.94 Production from \u2014 directionally or randomly oriented staple fibres; or \u2014 chopped yarns, of natural or man-made origin; followed in both cases by bonding into a nonwoven. 5604.10 Production from rubber thread or cord, not textile covered. 5604.90 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 56.05 Spinning of natural or man-made staple fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 56.06 Extrusion of man-made fibres combined with spinning; Twisting combined with gimping; Spinning of natural or man-made staple fibres; or Flocking combined with dyeing. 56.07-56.09 Spinning of natural fibres; or Extrusion of man-made fibres combined with spinning. Chapter 57 Carpets and other textile floor coverings Chapter note: For products of this Chapter non-originating jute fabric may be used as a backing. 57.01-57.05 Spinning of natural or man-made staple fibres combined with weaving or with tufting; Extrusion of man-made filament yarn combined with weaving or with tufting; Production from coir yarn or sisal yarn or jute yarn or classical ring spun viscose yarn; Tufting combined with dyeing or with printing; Tufting or weaving of man-made filament yarn combined with coating or with laminating; Flocking combined with dyeing or with printing; or Extrusion of man-made fibres combined with nonwoven techniques including needle punching. Chapter 58 Special woven fabrics; tufted textile fabrics; lace; tapestries; trimmings; embroidery 58.01-58.04 Spinning of natural or man-made staple fibres combined with weaving or with tufting; Extrusion of man-made filament yarn combined with weaving or with tufting; Weaving combined with dyeing or with flocking or with coating or with laminating or with metalizing; Tufting combined with dyeing or with printing; Flocking combined with dyeing or with printing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). 58.05 CTH 58.06-58.09 Spinning of natural or man-made staple fibres combined with weaving or with tufting; Extrusion of man-made filament yarn combined with weaving or with tufting; Weaving combined with dyeing or with flocking or with coating or with laminating or with metalizing; Tufting combined with dyeing or with printing; Flocking combined with dyeing or with printing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). 58.10 Embroidering in which the value of non-originating materials of any heading, except that of the product, used does not exceed 50 % of the EXW of the product. 58.11 Spinning of natural or man-made staple fibres combined with weaving or with tufting; Extrusion of man-made filament yarn combined with weaving or with tufting; Weaving combined with dyeing or with flocking or with coating or with laminating or with metalizing; Tufting combined with dyeing or with printing; Flocking combined with dyeing or with printing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 59 Impregnated, coated, covered or laminated textile fabrics; textile articles of a kind suitable for industrial use 59.01 Weaving combined with dyeing or with flocking or with coating or with laminating or with metalising; or Flocking combined with dyeing or with printing. 59.02 \u2014 Containing not more than 90 % by weight of textile materials: Weaving. \u2014 Others: Extrusion of man-made fibres combined with weaving. 59.03 Weaving, knitting or crocheting combined with impregnating or with coating or with covering or with laminating or with metalising; Weaving combined with printing; or Printing (as standalone operation). 59.04 Calendaring combined with dyeing, coating, laminating or metalizing. Non-originating jute fabric may be used as a backing; or Weaving combined with dyeing or with coating or with laminating or with metalising. Non-originating jute fabric may be used as a backing. 59.05 \u2014 Impregnated, coated, covered or laminated with rubber, plastics or other materials: Weaving, knitting or non-woven fabric formation combined with impregnating or with coating or with covering or with laminating or with metalising. \u2014 Others: Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Weaving, knitting or nonwoven fabric formation combined with dyeing or with coating or with laminating; Weaving combined with printing; or Printing (as standalone operation). 59.06 \u2014 Knitted or crocheted fabrics: Spinning of natural or man-made staple fibres combined with knitting or with crocheting; Extrusion of man-made filament yarn combined with knitting or with crocheting; Knitting or crocheting combined with rubberising; or Rubberising combined with at least two other main preparatory or finishing operations (such as calendering, shrink-resistance processes, heat setting, permanent finishing) provided that the value of non-originating materials used does not exceed 50 % of the EXW of the product. \u2014 Other fabrics made of synthetic filament yarn, containing more than 90 % by weight of textile materials: Extrusion of man-made fibres combined with weaving. \u2014 Others: Weaving, knitting or nonwoven process combined with dyeing or with coating or with rubberising; Yarn dyeing combined with weaving, knitting or nonwoven process; or Rubberising combined with at least two other main preparatory or finishing operations (such as calendering, shrink-resistance processes, heat setting, permanent finishing) provided that the value of non-originating materials used does not exceed 50 % of the EXW of the product. 59.07 Weaving, knitting or nonwoven fabric formation combined with dyeing or with printing or with coating or with impregnating or with covering; Flocking combined with dyeing or with printing; or Printing (as standalone operation). 59.08 \u2014 Incandescent gas mantles, impregnated: Production from tubular knitted or crocheted gas-mantle fabric. \u2014 Others: CTH 59.09-59.11 Spinning of natural or of man-made staple fibres combined with weaving; Extrusion of man-made fibres combined with weaving; Weaving combined with dyeing or with coating or with laminating; or Coating, flocking, laminating or metalizing combined with at least two other main preparatory or finishing operations (such as calendering, shrink-resistance processes, heat setting, permanent finishing) provided that the value of non-originating materials used does not exceed 50 % of the EXW of the product. Chapter 60 Knitted or crocheted fabrics 60.01-60.06 Spinning of natural or man-made staple fibres combined with knitting or with crocheting; Extrusion of man-made filament yarn combined with knitting or with crocheting; Knitting or crocheting combined with dyeing or with flocking or with coating or with laminating or with printing; Flocking combined with dyeing or with printing; Yarn dyeing combined with knitting or with crocheting; or Twisting or texturing combined with knitting or with crocheting provided that the value of non-originating non-twisted or non-textured yarns used does not exceed 50 % of the EXW of the product. Chapter 61 Articles of apparel and clothing accessories, knitted or crocheted 61.01-61.17 \u2014 Obtained by sewing together or otherwise assembling, two or more pieces of knitted or crocheted fabric which have been either cut to form or obtained directly to form: Knitting or crocheting combined with making-up including cutting of fabric. \u2014 Others: Spinning of natural or man-made staple fibres combined with knitting or with crocheting; Extrusion of man-made filament yarn combined with knitting or with crocheting; or Knitting and making-up in one operation. Chapter 62 Articles of apparel and clothing accessories, not knitted or crocheted 62.01 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.02 \u2014 Embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.03 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.04 \u2014 Embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.05 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.06 \u2014 Embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.07-62.08 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.09 \u2014 Embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.10 \u2014 Fire-resistant equipment of fabric covered with foil of aluminised polyester: Weaving combined with making-up including cutting of fabric; or Coating or laminating combined with making-up including cutting of fabric, provided that the value of non-originating uncoated or unlaminated fabric used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.11 \u2014 Women's, or girls' garments, embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.12 \u2014 Knitted or crocheted obtained by sewing together or otherwise assembling, two or more pieces of knitted or crocheted fabric which have been either cut to form or obtained directly to form: Knitting combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.13-62.14 \u2014 Embroidered: Weaving combined with making-up including cutting of fabric; Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product; or Making-up including cutting of fabric preceded by printing (as standalone operation). \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.15 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.16 \u2014 Fire-resistant equipment of fabric covered with foil of aluminised polyester: Weaving combined with making-up including cutting of fabric; or Coating or laminating combined with making-up including cutting of fabric, provided that the value of non-originating uncoated or unlaminated fabric used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.17 \u2014 Embroidered: Weaving combined with making-up including cutting of fabric; Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product; or Making-up including cutting of fabric preceded by printing (as standalone operation). \u2014 Fire-resistant equipment of fabric covered with foil of aluminised polyester: Weaving combined with making-up including cutting of fabric; or Coating or laminating combined with making-up including cutting of fabric, provided that the value of non-originating uncoated or unlaminated fabric used does not exceed 40 % of the EXW of the product. \u2014 Interlinings for collars and cuffs, cut out: CTH, provided that the value of all the non-originating materials used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving combined with making-up including cutting of fabric. Chapter 63 Other made up textile articles; sets; worn clothing and worn textile articles; rags 63.01-63.04 \u2014 Of felt, of nonwovens: Nonwoven fabric formation combined with making-up including cutting of fabric. \u2014 Others: \u2014 Embroidered: Weaving or knitting or crocheting combined with making-up including cutting of fabric; or Production from unembroidered fabric (other than knitted or crocheted), provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. \u2014 Others: Weaving, knitting or crocheting combined with making-up including cutting of fabric. 63.05 Extrusion of man-made fibres or spinning of natural or man-made staple fibres, combined with weaving or with knitting and making-up including cutting of fabric. 63.06 \u2014 Of nonwovens: Nonwoven fabric formation combined with making-up including cutting of fabric. \u2014 Others: Weaving combined with making-up including cutting of fabric. 63.07 MaxNOM 40 % (EXW). 63.08 Each item in the set must satisfy the rule which would apply to it if it were not included in the set; however, non-originating articles may be incorporated, provided that their total value does not exceed 15 % of the EXW of the set. 63.09-63.10 CTH SECTION XII FOOTWEAR, HEADGEAR, UMBRELLAS, SUN UMBRELLAS, WALKING-STICKS, SEAT-STICKS, WHIPS, RIDING-CROPS AND PARTS THEREOF; PREPARED FEATHERS AND ARTICLES MADE THEREWITH; ARTIFICIAL FLOWERS; ARTICLE OF HUMAN HAIR Chapter 64 Footwear, gaiters and the like; parts of such articles 64.01-64.05 Production from non-originating materials of any heading, except from non-originating assemblies of uppers affixed to inner soles or to other sole components of heading 64.06. 64.06 CTH Chapter 65 Headgear and parts thereof 65.01-65.07 CTH Chapter 66 Umbrellas, sun umbrellas, walking-sticks, seat-sticks, whips, riding-crops and parts thereof 66.01-66.03 CTH; or MaxNOM 50 % (EXW). Chapter 67 Prepared feathers and down and articles made of feathers or of down; artificial flowers; articles of human hair 67.01-67.04 CTH SECTION XIII ARTICLES OF STONE, PLASTER, CEMENT, ASBESTOS, MICA OR SIMILAR MATERIALS; CERAMIC PRODUCTS; GLASS AND GLASSWARE Chapter 68 Articles of stone, plaster, cement, asbestos, mica or similar materials 68.01-68.15 CTH; or MaxNOM 70 % (EXW). Chapter 69 Ceramic products 69.01-69.14 CTH Chapter 70 Glass and glassware 70.01-70.09 CTH; or MaxNOM 50 % (EXW). 70.10 CTH 70.11 CTH; or MaxNOM 50 % (EXW). 70.13 CTH except from non-originating materials of heading 70.10. 70.14-70.20 CTH; or MaxNOM 50 % (EXW). SECTION XIV NATURAL OR CULTURED PEARLS, PRECIOUS OR SEMI-PRECIOUS STONES, PRECIOUS METALS, METALS CLAD WITH PRECIOUS METAL, AND ARTICLES THEREOF; IMITATION JEWELLERY; COIN Chapter 71 Natural or cultured pearls, precious or semi-precious stones, precious metals, metals clad with precious metal, and articles thereof; imitation jewellery; coin 71.01-71.05 Production from non-originating materials of any heading. 71.06 \u2014 Unwrought: CTH except from non-originating materials of headings 71.06, 71.08 and 71.10; Electrolytic, thermal or chemical separation of non-originating precious metals of headings 71.06, 71.08 and 71.10; or Fusion or alloying of non-originating precious metals of headings 71.06, 71.08 and 71.10 with each other or with base metals or purification. \u2014 Semi-manufactured or in powder form: Production from non-originating unwrought precious metals. 71.07 Production from non-originating materials of any heading. 71.08 \u2014 Unwrought: CTH except from non-originating materials of headings 71.06, 71.08 and 71.10; Electrolytic, thermal or chemical separation of non-originating precious metals of headings 71.06, 71.08 and 71.10; or Fusion or alloying of non-originating precious metals of headings 71.06, 71.08 and 71.10 with each other or with base metals or purification. \u2014 Semi-manufactured or in powder form: Production from non-originating unwrought precious metals. 71.09 Production from non-originating materials of any heading. 71.10 \u2014 Unwrought: CTH except from non-originating materials of headings 71.06, 71.08 and 71.10; Electrolytic, thermal or chemical separation of non-originating precious metals of headings 71.06, 71.08 and 71.10; or Fusion or alloying of non-originating precious metals of headings 71.06, 71.08 and 71.10 with each other or with base metals or purification. \u2014 Semi-manufactured or in powder form: Production from non-originating unwrought precious metals. 71.11 Production from non-originating materials of any heading. 71.12-71.18 CTH SECTION XV BASE METALS AND ARTICLES OF BASE METAL Chapter 72 Iron and Steel 72.01-72.06 CTH 72.07 CTH except from non-originating materials of heading 72.06. 72.08-72.17 CTH except from non-originating materials of headings 72.08 to 72.17. 72.18 CTH 72.19-72.23 CTH except from non-originating materials of headings 72.19 to 72.23. 72.24 CTH 72.25-72.29 CTH except from non-originating materials of headings 72.25 to 72.29. Chapter 73 Articles of iron or steel 7301.10 CC except from non-originating materials of headings 72.08 to 72.17. 7301.20 CTH 73.02 CC except from non-originating materials of headings 72.08 to 72.17. 73.03 CTH 73.04-73.06 CC except from non-originating materials of headings 72.13 to 72.17, 72.21 to 72.23 and 72.25 to 72.29. 73.07 \u2014 Tube or pipe fittings of stainless steel: CTH except from non-originating forged blanks; however, non-originating forged blanks may be used provided that their value does not exceed 50 % of the EXW of the product. \u2014 Others: CTH 73.08 CTH except from non-originating materials of subheading 7301.20. 7309.00-7315.19 CTH 7315.20 CTH; or MaxNOM 50 % (EXW). 7315.81-7326.90 CTH Chapter 74 Copper and articles thereof 74.01-74.02 CTH 74.03 Production from non-originating materials of any heading. 74.04-74.07 CTH 74.08 CTH and MaxNOM 50 % (EXW). 74.09-74.19 CTH Chapter 75 Nickel and articles thereof 75.01 CTH 75.02 Production from non-originating materials of any heading. 75.03-75.08 CTH Chapter 76 Aluminium and articles thereof 76.01 CTH and MaxNOM 50 % (EXW); or Thermal or electrolytic treatment from unalloyed aluminium or waste and scrap of aluminium. 76.02 CTH 76.03-76.16 CTH and MaxNOM 50 % (EXW) (3). Chapter 78 Lead and articles thereof 7801.10 Production from non-originating materials of any heading. 7801.91-7806.00 CTH Chapter 79 Zinc and articles thereof 79.01-79.07 CTH Chapter 80 Tin and articles thereof 80.01-80.07 CTH Chapter 81 Other base metals; cermets; articles thereof 81.01-81.13 Production from non-originating materials of any heading. Chapter 82 Tools, implements, cutlery, spoons and forks, of base metal; parts thereof of base metal 8201.10-8205.70 CTH; or MaxNOM 50 % (EXW). 8205.90 CTH, however, non-originating tools of heading 82.05 may be incorporated into the set, provided that their total value does not exceed 15 % of the EXW of the set. 82.06 CTH except from non-originating materials of headings 82.02 to 82.05; however, non-originating tools of headings 82.02 to 82.05 may be incorporated into the set, provided that their total value does not exceed 15 % of the EXW of the set. 82.07-82.15 CTH; or MaxNOM 50 % (EXW). Chapter 83 Miscellaneous articles of base metal 83.01-83.11 CTH; or MaxNOM 50 % (EXW). SECTION XVI MACHINERY AND MECHANICAL APPLIANCE; ELECTRICAL EQUIPMENT; PARTS THEREOF; SOUND RECORDERS AND REPRODUCERS, TELEVISION IMAGE AND SOUND RECORDERS AND REPRODUCERS, AND PARTS AND ACCESSORIES OF SUCH ARTICLES Chapter 84 Nuclear reactors, boilers, machinery and mechanical appliances; parts thereof 84.01-84.06 CTH; or MaxNOM 50 % (EXW). 84.07-84.08 MaxNOM 50 % (EXW). 84.09-84.12 CTH; or MaxNOM 50 % (EXW). 8413.11-8415.10 CTSH; or MaxNOM 50 % (EXW). 8415.20 CTH; or MaxNOM 50 % (EXW). 8415.81-8415.90 CTSH; or MaxNOM 50 % (EXW). 84.16-84.20 CTH; or MaxNOM 50 % (EXW). 84.21 CTSH; or MaxNOM 50 % (EXW). 84.22-84.24 CTH; or MaxNOM 50 % (EXW). 84.25-84.30 CTH except from non-originating materials of heading 84.31; or MaxNOM 50 % (EXW). 84.31-84.43 CTH; or MaxNOM 50 % (EXW). 84.44-84.47 CTH except from non-originating materials of heading 84.48; or MaxNOM 50 % (EXW). 84.48-84.55 CTH; or MaxNOM 50 % (EXW). 84.56-84.65 CTH except from non-originating materials of heading 84.66; or MaxNOM 50 % (EXW). 84.66-84.68 CTH; or MaxNOM 50 % (EXW). 84.70-84.72 CTH except from non-originating materials of heading 84.73; or MaxNOM 50 % (EXW). 84.73-84.78 CTH; or MaxNOM 50 % (EXW). 8479.10-8479.40 CTSH; or MaxNOM 50 % (EXW). 8479.50 CTH; or MaxNOM 50 % (EXW). 8479.60-8479.82 CTSH; or MaxNOM 50 % (EXW). 8479.89 CTH; or MaxNOM 50 % (EXW). 8479.90 CTSH; or MaxNOM 50 % (EXW). 84.80 CTH; or MaxNOM 50 % (EXW). 84.81 CTSH; or MaxNOM 50 % (EXW). 84.82-84.87 CTH; or MaxNOM 50 % (EXW). Chapter 85 Electrical machinery and equipment and parts thereof; sound recorders and reproducers, television image and sound recorders and reproducers, and parts and accessories of such articles 85.01-85.02 CTH except from non-originating materials of heading 85.03; or MaxNOM 50 % (EXW). 85.03-85.06 CTH; or MaxNOM 50 % (EXW). 85.07 \u2014 Accumulators containing one or more battery cells or battery modules and the circuitry to interconnect them amongst themselves, often referred to as \"battery packs\", of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH except from non-originating active cathode materials; or MaxNOM 30 % (EXW) (4). \u2014 Battery cells, battery modules and parts thereof, intended to be incorporated into an electric accumulator of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH except from non-originating active cathode materials; or MaxNOM 35 % (EXW) (5) \u2014 others CTH; or MaxNOM 50 % (EXW). 85.08-85.18 CTH; or MaxNOM 50 % (EXW). 85.19-85.21 CTH except from non-originating materials of heading 85.22; or MaxNOM 50 % (EXW). 85.22-85.23 CTH; or MaxNOM 50 % (EXW). 85.25-85.27 CTH except from non-originating materials of heading 85.29; or MaxNOM 50 % (EXW). 85.28-85.34 CTH; or MaxNOM 50 % (EXW). 85.35-85.37 CTH except from non-originating materials of heading 85.38; or MaxNOM 50 % (EXW). 8538.10-8541.90 CTH; or MaxNOM 50 % (EXW). 8542.31-8542.39 CTH; Non-originating materials undergo a diffusion; or MaxNOM 50 % (EXW). 8542.90-8543.90 CTH; or MaxNOM 50 % (EXW). 85.44-85.48 MaxNOM 50 % (EXW). SECTION XVII VEHICLES, AIRCRAFT, VESSELS AND ASSOCIATED TRANSPORT EQUIPMENT Chapter 86 Railway or tramway locomotives, rolling-stock and parts thereof; railway or tramway track fixtures and fittings and parts thereof; mechanical (including electro-mechanical) traffic signalling equipment of all kinds 86.01-86.09 CTH except from non-originating materials of heading 86.07; or MaxNOM 50 % (EXW). Chapter 87 Vehicles other than railway or tramway rolling-stock, and parts and accessories thereof 87.01 MaxNOM 45 % (EXW). 87.02-87.04 \u2014 vehicles with both internal combustion piston engine and electric motor as motors for propulsion capable of being charged by plugging to external source of electric power (\"plug-in hybrid\"); \u2014 vehicles with only electric motor for propulsion MaxNOM 45 % (EXW) and battery packs of heading 85.07 of a kind used as the primary source of electrical power for propulsion of the vehicle must be originating (6). \u2014 others MaxNOM 45 % (EXW) (7). 87.05-87.07 MaxNOM 45 % (EXW). 87.08-87.11 CTH; or MaxNOM 50 % (EXW). 87.12 MaxNOM 45 % (EXW). 87.13-87.16 CTH; or MaxNOM 50 % (EXW). Chapter 88 Aircraft, spacecraft, and parts thereof 88.01-88.05 CTH; or MaxNOM 50 % (EXW). Chapter 89 Ships, boats and floating structures 89.01-89.08 CC; or MaxNOM 40 % (EXW). SECTION XVIII OPTICAL, PHOTOGRAPHIC, CINEMATOGRAPHIC, MEASURING, CHECKING, PRECISION, MEDICAL OR SURGICAL INSTRUMENTS AND APPARATUS; CLOCKS AND WATCHES; MUSICAL INSTRUMENTS; PARTS AND ACCESSORIES THEREOF Chapter 90 Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus; parts and accessories thereof 9001.10-9001.40 CTH; or MaxNOM 50 % (EXW). 9001.50 CTH; Surfacing of the semi-finished lens into a finished ophthalmic lens with optical corrective power meant to be mounted on a pair of spectacles; Coating of the lens through appropriated treatments to improve vision and ensure protection of the wearer; or MaxNOM 50 % (EXW). 9001.90-9033.00 CTH; or MaxNOM 50 % (EXW). Chapter 91 Clocks and watches and parts thereof 91.01-91.14 CTH; or MaxNOM 50 % (EXW). Chapter 92 Musical instruments; parts and accessories of such articles 92.01-92.09 MaxNOM 50 % (EXW). SECTION XIX ARMS AND AMMUNITION; PARTS AND ACCESSORIES THEREOF Chapter 93 Arms and ammunition; parts and accessories thereof 93.01-93.07 MaxNOM 50 % (EXW). SECTION XX MISCELLANEOUS MANUFACTURED ARTICLES Chapter 94 Furniture; bedding, mattresses, mattress supports, cushions and similar stuffed furnishings; lamps and lighting fittings, not elsewhere specified or included; illuminated signs, illuminated name-plates and the like; prefabricated buildings 94.01-94.06 CTH; or MaxNOM 50 % (EXW). Chapter 95 Toys, games and sports requisites; parts and accessories thereof 95.03-95.08 CTH; or MaxNOM 50 % (EXW). Chapter 96 Miscellaneous manufactured articles 96.01-96.04 CTH; or MaxNOM 50 % (EXW). 96.05 Each item in the set shall satisfy the rule which would apply to it if it were not included in the set, provided that non-originating articles may be incorporated, provided that their total value does not exceed 15 % of the EXW of the set. 96.06-9608.40 CTH; or MaxNOM 50 % (EXW). 9608.50 Each item in the set shall satisfy the rule which would apply to it if it were not included in the set, provided that non-originating articles may be incorporated, provided that their total value does not exceed 15 % of the EXW of the set. 9608.60-96.20 CTH; or MaxNOM 50 % (EXW). SECTION XXI WORKS OF ART, COLLECTORS' PIECES AND ANTIQUES Chapter 97 Works of Art, Collectors' Pieces and Antiques 97.01-97.06 CTH (1) Prepared or preserved tunas, skipjack and bonito (Sarda spp.), whole or in pieces (excl. minced) classified under subheading 1604.14 may be considered as originating under alternative product-specific rules of origin within annual quotas as specified in Annex 4. (2) Prepared or preserved tunas, skipjack or other fish of genus Euthynnus (excl. whole or in pieces) classified under subheading 1604.20 may be considered as originating under alternative product-specific rules of origin within annual quotas as specified in Annex 4. (3) Certain aluminium products may be considered as originating under alternative product-specific rules of origin with annual quotas as specified in Annex 4. (4) For the period from the entry into force of this Agreement until 31 December 2026 alternative product-specific rules of origin apply, as specified in Annex 5. (5) For the period from the entry into force of this Agreement until 31 December 2026 alternative product-specific rules of origin apply, as specified in Annex 5. (6) For the period from the entry into force of this Agreement until 31 December 2026 alternative product-specific rules of origin apply, as specified in Annex 5. (7) For hybrid vehicles with both internal combustion engine and electric motor as motors for propulsion, other than those capable of being charged by plugging to external source of electric power, alternative product-specific rules of origin apply for the period from the entry into force of this Agreement until 31 December 2026, as specified in Annex 5. ANNEX 4 ORIGIN QUOTAS AND ALTERNATIVES TO THE PRODUCT-SPECIFIC RULES OF ORIGIN IN ANNEX 3 Common provisions 1. For the products listed in the tables below, the corresponding rules of origin are alternatives to those set out in Annex 3, within the limits of the applicable annual quota. 2. A statement on origin made out pursuant to this Annex shall contain the following statement: \"Origin quotas - Product originating in accordance with Annex 4\". 3. In the Union, any quantities referred to in this Annex shall be managed by the European Commission, which shall take all administrative actions it deems advisable for their efficient management in respect of the applicable legislation of the Union. 4. In the United Kingdom, any quantities referred to in this Annex shall be managed by its customs authority, which shall take all administrative actions it deems advisable for their efficient management in respect of the applicable legislation in the United Kingdom. 5. The importing Party shall manage the origin quotas on a first-come first-served basis and shall calculate the quantity of products entered under these origin quotas on the basis of that Party's imports. SECTION 1 Annual quota allocation for canned tuna Harmonised system classification (2017) Product description Alternative product-specific rule Annual quota for exports from the Union to the United Kingdom (net weight) Annual quota for exports from the United Kingdom to the Union (net weight) 1604.14 Prepared or preserved tunas, skipjack and bonito (Sarda spp.), whole or in pieces (excl. minced) CC 3 000 tonnes 3 000 tonnes 1604.20 Other prepared or preserved fish Of tuna, skipjack or other fish of the genus Euthynnus (excl. whole or in pieces) CC 4 000 tonnes 4 000 tonnes Of other fish - - - SECTION 2 Annual quota allocation for aluminium products (1) Table 1 Quotas applicable from 1 January 2021 until 31 December 2023 Harmonised system classification (2017) Product description Alternative product-specific rule Annual quota for exports from the Union to the United Kingdom (net weight) Annual quota for exports from the United Kingdom to the Union (net weight) 76.03, 76.04, 76.06, 76.08-76.16 Aluminium products and articles of aluminium (excluding aluminium wire and aluminium foil) CTH 95 000 tonnes 95 000 tonnes 76.05 Aluminium wire CTH except from non-originating materials of heading 76.04 76.07 Aluminium foil CTH except from non-originating materials of heading 76.06 Table 2 Quotas applicable from 1 January 2024 until 31 December 2026 Harmonised system classification (2017) Product description Alternative product-specific rule Annual quota for exports from the Union to the United Kingdom (net weight) Annual quota for exports from the United Kingdom to the Union (net weight) 76.03, 76.04, 76.06, 76.08-76.16 Aluminium products and articles of aluminium (excluding aluminium wire and aluminium foil) CTH 72 000 tonnes 72 000 tonnes 76.05 Aluminium wire CTH except from non-originating materials of heading 76.04 76.07 Aluminium foil CTH except from non-originating materials of heading 76.06 Table 3 Quotas applicable from 1 January 2027 onwards Harmonised system classification (2017) Product description Alternative product-specific rule Annual quota for exports from the Union to the United Kingdom (net weight) Annual quota for exports from the United Kingdom to the Union (net weight) 76.04 Aluminium bars, rods and profiles CTH 57 500 tonnes 57 500 tonnes 76.06 Aluminium plates, sheets and strip, of a thickness exceeding 0,2 mm CTH 76.07 Aluminium foil CTH except from non-originating materials of heading 76.06 Review of quotas for aluminium products in Table 3 in Section 2 1. Not earlier than 5 years from the entry into force of this Agreement and not earlier than 5 years from the completion of any review referred to in this paragraph, the Trade Partnership Committee, at the request of either Party and assisted by the Trade Specialised Committee on Customs Cooperation and Rules of Origin, shall review the quotas for aluminium contained in Table 3 in Section 2. 2. The review referred to in paragraph 1 shall be made on the basis of available information about the market conditions in both Parties and information about their imports and exports of relevant products. 3. On the basis of the result of a review carried out pursuant to paragraph 1, the Partnership Council may adopt a decision to increase or maintain the quantity, to change the scope, or to apportion or change any apportionment between products, of the quotas for aluminium contained in Table 3 in Section 2. (1) The quantities listed in each table in Section 2 are the entire quota quantities available (for exports from the Union to the United Kingdom, and for exports from the United Kingdom to the Union, respectively) for all the products listed in that table. ANNEX 5 TRANSITIONAL PRODUCT-SPECIFIC RULES FOR ELECTRIC ACCUMULATORS AND ELECTRIFIED VEHICLES SECTION 1 Interim product-specific rules applicable from the entry into force of this Agreement until 31 December 2023 1. For the products listed in column 1 below, the product-specific rule listed in column 2 shall apply for the period from the entry into force of this Agreement until 31 December 2023. Column 1 Harmonised System classification (2017) including specific description Column 2 Product-specific rule of origin applicable from the entry into force of this Agreement until 31 December 2023 85.07 \u2014 Accumulators containing one or more battery cells or battery modules and the circuitry to interconnect them amongst themselves, often referred to as \"battery packs\", of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTSH; Assembly of battery packs from non-originating battery cells or battery modules; or MaxNOM 70 % (EXW) \u2014 Battery cells, battery modules, and parts thereof, intended to be incorporated into an electric accumulator of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH; or MaxNOM 70 % (EXW) 87.02-87.04 \u2014 vehicles with both internal combustion engine and electric motor as motors for propulsion other than those capable of being charged by plugging to external source of electric power (\"hybrid\"); \u2014 vehicles with both internal combustion piston engine and electric motor as motors for propulsion capable of being charged by plugging to external source of electric power (\"plug-in hybrid\"); \u2014 vehicles with only electric motor for propulsion MaxNOM 60 % (EXW) SECTION 2 Interim product-specific rules applicable from 1 January 2024 until 31 December 2026 1. For the products listed in column 1 below, the product specific rule listed in column 2 shall apply for the period from 1 January 2024 until 31 December 2026. Column 1 Harmonised System classification (2017) including specific description Column 2 Product-specific rule of origin applicable from 1 January 2024 until 31 December 2026 85.07 \u2014 Accumulators containing one or more battery cells or battery modules and the circuitry to interconnect them amongst themselves, often referred to as \"battery packs\", of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH except from non-originating active cathode materials; or MaxNOM 40 % (EXW) \u2014 Battery cells, battery modules, and parts thereof, intended to be incorporated into an electric accumulator of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH except from non-originating active cathode materials; or MaxNOM 50 % (EXW) 87.02-87.04 \u2014 vehicles with both internal combustion engine and electric motor as motors for propulsion other than those capable of being charged by plugging to external source of electric power (\"hybrid\"); \u2014 vehicles with both internal combustion piston engine and electric motor as motors for propulsion capable of being charged by plugging to external source of electric power (\"plug-in hybrid\"); \u2014 vehicles with only electric motor for propulsion MaxNOM 55 % (EXW) SECTION 3 Review of product-specific rules for heading 85.07 1. Not earlier than 4 years from the entry into force of this Agreement, the Trade Partnership Committee shall, on request of either Party and assisted by the Trade Specialised Committee on Customs Cooperation and Rules of Origin, review the product-specific rules for heading 85.07 applicable as from 1 January 2027, contained in Annex 3. 2. The review referred to in paragraph 1, shall be made on the basis of available information about the markets within the Parties, such as the availability of sufficient and suitable originating materials, the balance between supply and demand and other relevant information. 3. On the basis of the results of the review carried out pursuant to paragraph 1, the Partnership Council may adopt a decision to amend the product-specific rules for heading 85.07 applicable as from 1 January 2027, contained in Annex 3. ANNEX 6 SUPPLIER\u2019S DECLARATION 1. A supplier\u2019s declaration shall have the content set out in this Annex. 2. Except in the cases referred to in point 3, a supplier\u2019s declaration shall be made out by the supplier for each consignment of products in the form provided for in Appendix 6-A and annexed to the invoice, or to any other document describing the products concerned in sufficient detail to enable them to be identified. 3. Where a supplier regularly supplies a particular customer with products for which the production carried out in a Party is expected to remain constant for a period of time, that supplier may provide a single supplier\u2019s declaration to cover subsequent consignments of those products (the \"long-term supplier\u2019s declaration\"). A long-term supplier\u2019s declaration is normally valid for a period of up to two years from the date of making out the declaration. The customs authorities of the Party where the declaration is made out may lay down the conditions under which longer periods may be used. The long-term supplier\u2019s declaration shall be made out by the supplier in the form provided for in Appendix 6-B and shall describe the products concerned in sufficient detail to enable them to be identified. The supplier shall inform the customer immediately if the long-term supplier\u2019s declaration ceases to apply to the products supplied. 4. The supplier making out a declaration shall be prepared to submit at any time, at the request of the customs authorities of the Party where the declaration is made out, all appropriate documents proving that the information given on that declaration is correct. Appendix 6-A SUPPLIER'S DECLARATION The supplier's declaration, the text of which is provided below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced. SUPPLIER'S DECLARATION I, the undersigned, the supplier of the products covered by the annexed document, declare that: 1. The following materials which do not originate in [indicate the name of the relevant Party] have been used in [indicate the name of the relevant Party] to produce these products: Description of the products supplied(1) Description of non-originating materials used HS heading of non-originating materials used(2) Value of non-originating materials used(2)(3) Total value 2. All the other materials used in [indicate the name of the relevant Party] to produce those products originate in [indicate the name of the relevant Party] I undertake to make available any further supporting documents required. \u2026 (Place and Date) \u2026 (Name and position of the undersigned, name and address of company) \u2026 (Signature)(6) Appendix 6-B LONG-TERM SUPPLIER'S DECLARATION The long-term supplier's declaration, the text of which is given below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced. LONG-TERM SUPPLIER'S DECLARATION I, the undersigned, the supplier of the products covered by the annexed document, which are regularly supplied to (4) \u2026, declare that: 1. The following materials which do not originate in [indicate the name of the relevant Party] have been used in [indicate the name of the relevant Party] to produce these products: Description of the products supplied(1) Description of non-originating materials used HS heading of non-originating materials used(2) Value of non-originating materials used(2)(3) Total value 2. All the other materials used in [indicate the name of the relevant Party] to produce those products originate in a Party [indicate the name of the relevant Party]; This declaration is valid for all subsequent consignments of these products dispatched from \u2026 to \u2026 (5) I undertake to inform \u2026 (4) immediately if this declaration ceases to be valid. \u2026 (Place and Date) \u2026 (Name and position of the undersigned, name and address of company) \u2026 (Signature)(6) Footnotes (1) Where the invoice or other document to which the declaration is annexed relates to different kinds of products, or to products which do not incorporate non-originating materials to the same extent, the supplier must clearly differentiate them. (2) The information requested does not have to be given unless it is necessary. Examples: One of the rules for garments of Chapter 62 provides \"Weaving combined with making-up including cutting of fabric\". If a manufacturer of such garments in a Party uses fabric imported from the other Party which has been obtained there by weaving non-originating yarn, it is sufficient for the supplier in the latter Party to describe in his declaration the non-originating material used as yarn, without it being necessary to indicate the HS heading and the value of such yarn. A producer of wire of iron of HS heading 72.17 who has produced it from non-originating iron bars should indicate in the second column \"bars of iron\". Where that wire is to be used in the production of a machine for which the rule contains a limitation for all non-originating materials used to a certain percentage value, it is necessary to indicate in the third column the value of non-originating bars. (3) \"Value of non-originating materials used\" means the value of the non-originating materials used in the production of the product, which is its customs value at the time of importation, including freight, insurance if appropriate, packing and all other costs incurred in transporting the materials to the importation port in the Party where the producer of the product is located; where the value of the non-originating materials is not known and cannot be ascertained, the first ascertainable price paid for the non-originating materials in the Union or in the United Kingdom is used. (4) Name and address of the customer (5) Insert dates (6) This field may contain an electronic signature, a scanned image or other visual representation of the signer\u2019s handwritten signature instead of original signatures, where appropriate. ANNEX 7 TEXT OF THE STATEMENT ON ORIGIN The statement on origin referred to in Article 56 of this Agreement shall be made out using the text set out below in one of the following language versions and in accordance with the laws and regulations of the exporting Party. If the statement on origin is handwritten, it shall be written in ink in printed characters. The statement on origin shall be made out in accordance with the respective footnotes. The footnotes do not have to be reproduced. Bulgarian version Croatian version Czech version Danish version Dutch version English version Estonian version Finnish version French version German version Greek version Hungarian version Italian version Latvian version Lithuanian version Maltese version Polish version Portuguese version Romanian version Slovak version Slovenian version Spanish version Swedish version (Period: from \u2026 to \u2026 (1)) The exporter of the products covered by this document (Exporter Reference No ...(2)) declares that, except where otherwise clearly indicated, these products are of ...(3) preferential origin. \u2026(4) (Place and date) \u2026 (Name of the exporter) (1) If the statement on origin is completed for multiple shipments of identical originating products within the meaning of point (b) of Article 56(4) of this Agreement, indicate the period for which the statement on origin is to apply. That period shall not exceed 12 months. All importations of the product must occur within the period indicated. If a period is not applicable, the field may be left blank. (2) Indicate the reference number by which the exporter is identified. For the Union exporter, this will be the number assigned in accordance with the laws and regulations of the Union. For the United Kingdom exporter, this will be the number assigned in accordance with the laws and regulations applicable within the United Kingdom. Where the exporter has not been assigned a number, this field may be left blank. (3) Indicate the origin of the product: the United Kingdom or the Union. (4) Place and date may be omitted if the information is contained on the document itself. ANNEX 8 JOINT DECLARATION CONCERNING THE PRINCIPALITY OF ANDORRA 1. Products originating in the Principality of Andorra that fall within Chapters 25 to 97 of the Harmonised System shall be accepted by the United Kingdom as originating in the Union within the meaning of this Agreement. 2. Paragraph 1 only applies if, by virtue of the customs union established by Council Decision 90/680/EEC of 26 November 1990 on the conclusion of an agreement in the form of an exchange of letters between the European Economic Community and the Principality of Andorra, the Principality of Andorra applies to products originating in the United Kingdom the same preferential tariff treatment as the Union applies to such products. 3. Part Two, Heading One, Title I, Chapter 2 of this Agreement applies mutatis mutandis for the purpose of defining the originating status of products referred to in paragraph 1 of this Joint Declaration. ANNEX 9 JOINT DECLARATION CONCERNING THE REPUBLIC OF SAN MARINO 1. Products originating in the Republic of San Marino shall be accepted by the United Kingdom as originating in the Union within the meaning of this Agreement. 2. Paragraph 1 only applies if, by virtue of the Agreement on Cooperation and Customs Union between the European Economic Community and the Republic of San Marino, done at Brussels on 16 December 1991, the Republic of San Marino applies to products originating in the United Kingdom the same preferential tariff treatment as the Union applies to such products. 3. Part Two, Heading One, Title I, Chapter 2 of this Agreement applies mutatis mutandis for the purposes of defining the originating status of products referred to in paragraph 1 of this Joint Declaration. ANNEX 10 CRITERIA REFERRED TO IN POINT (d) OF ARTICLE 87 The criteria referred to in point (d) of Article 87 of this Agreement are: (a) the information made available by the exporting Party for the purposes of obtaining import authorisation of a given product into the importing party according to Article 75 of this Agreement; (b) the outcome of audits and verifications by the importing party in accordance with Article 79 of this Agreement; (c) the frequency and severity of non-compliance detected by the importing party on products from the exporting party; (d) the exporting operators' past record as regards compliance with the requirements of the importing party; and (e) available scientific assessments and any other pertinent information regarding the risk associated with the products. ANNEX 11 MOTOR VEHICLES AND EQUIPMENT AND PARTS THEREOF Article 1 Definitions 1. For the purposes of this Annex, the following definitions apply: (a) \"WP.29\" means the World Forum for Harmonisation of Vehicle Regulations within the framework of the United Nations Economic Commission for Europe (\"UNECE\"); (b) \"1958 Agreement\" means the Agreement Concerning the Adoption of Harmonized Technical United Nations Regulations for Wheeled Vehicles, Equipment and Parts which can be Fitted and/or be Used on Wheeled Vehicles and the Conditions for Reciprocal Recognition of Approvals Granted on the Basis of these United Nations Regulations, done at Geneva on 20 March 1958, administered by the WP.29, and all subsequent amendments and revisions thereof; (c) \"1998 Agreement\" means the Agreement concerning the Establishing of Global Technical Regulations for Wheeled Vehicles, Equipment and Parts which can be Fitted and/or be Used on Wheeled Vehicles, done at Geneva on 25 June 1998, administered by the WP.29, and all subsequent amendments and revisions thereof; (d) \"UN Regulations\" means Regulations adopted in accordance with the 1958 Agreement; (e) \"GTR\" means a Global Technical Regulation established and placed on the Global Registry in accordance with the 1998 Agreement; (f) \"HS 2017\" means the 2017 edition of the Harmonised System Nomenclature issued by the World Customs Organization; (g) \"type approval\" means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements; (h) \"type-approval certificate\" means the document whereby an approval authority officially certifies that a type of vehicle, system, component or separate technical unit is type-approved. 2. Terms referred to in this Annex shall have the same meaning as they have in the 1958 Agreement or in Annex 1 to the TBT Agreement. Article 2 Product scope This Annex applies to the trade between the Parties of all categories of motor vehicles, equipment and parts thereof, as defined in Paragraph 1 of UNECE Consolidated Resolution on the Construction of Vehicles (R.E.3) (1), falling under, inter alia, Chapters 40, 84, 85, 87 and 94 of the HS 2017 (hereinafter referred to as \"products covered\"). Article 3 Objectives With regard to the products covered, the objectives of this Annex are to: (a) eliminate and prevent any unnecessary technical barriers to bilateral trade; (b) promote the compatibility and convergence of regulations based on international standards; (c) promote the recognition of approvals based on approval schemes applied under the agreements administered by WP.29; (d) reinforce competitive market conditions based on principles of openness, non-discrimination and transparency; (e) promote high levels of protection of human health, safety and the environment; and (f) maintain cooperation on issues of mutual interest to foster continued mutually beneficial development in trade. Article 4 Relevant international standards The Parties recognise that the WP.29 is the relevant international standardising body and that UN Regulations and GTRs under the 1958 Agreement and 1998 Agreement are relevant international standards for the products covered by this Annex. Article 5 Regulatory convergence based on relevant international standards 1. The Parties shall refrain from introducing or maintaining any domestic technical regulation, marking, or conformity assessment procedure diverging from UN Regulations or GTRs in areas covered by such Regulations or GTRs, including where the relevant UN Regulations or GTRs have not been completed but their completion is imminent, unless there are substantiated reasons why a specific UN Regulation or GTR is an ineffective or inappropriate means for the fulfilment of legitimate objectives pursued, for example, in the areas of road safety or the protection of the environment or human health. 2. A Party which introduces a divergent domestic technical regulation, marking, or conformity assessment procedure as referred to in paragraph 1, at the request of the other Party, shall identify the parts of the domestic technical regulation, marking, or conformity assessment procedure which substantially diverge from the relevant UN Regulations or GTRs and provide justification for the divergence. 3. Each Party shall systematically consider applying UN Regulations adopted after the entry into force of this Agreement, and shall inform each other of any changes regarding the implementation of those UN Regulations in its respective domestic legal system following the protocol established under the 1958 Agreement and in line with Articles 8 and 9. 4. Insofar as a Party has introduced or maintains domestic technical regulations, markings or conformity assessment procedures that diverge from UN Regulations or GTRs as permitted by paragraph 1, that Party shall review those domestic technical regulations, markings or conformity assessment procedures at regular intervals, preferably not exceeding five years, with a view to increasing their convergence with the relevant UN Regulations or GTRs. When reviewing their domestic technical regulations, markings and conformity assessment procedures, each Party shall consider whether the justification for the divergence still exists. The outcome of these reviews, including any scientific and technical information used, shall be notified to the other Party upon request. 5. Each Party shall refrain from introducing or maintaining domestic technical regulations, markings, or conformity assessment procedures which have the effect of prohibiting, restricting or increasing the burden for the importation and putting into service on their domestic market of products type-approved under UN Regulations for the areas covered by those UN Regulations unless such domestic technical regulations, markings or conformity assessment procedures are explicitly provided for by those UN Regulations. Article 6 Type approval and market surveillance 1. Each Party shall accept on its market products which are covered by a valid UN type-approval certificate as compliant with its domestic technical regulations, markings and conformity assessment procedures, without requiring any further testing or marking to verify or attest compliance with any requirement covered by the UN type-approval certificate concerned. In the case of vehicle approvals, the UN Universal International Whole Vehicle Type Approval (U-IWVTA) shall be considered valid in respect of the requirements covered by the U-IWVTA. UN type-approval certificates issued by a Party can only be considered valid if that Party has acceded to the relevant UN Regulations. 2. Each Party shall only be required to accept valid UN type-approval certificates issued pursuant to the latest version of the UN Regulations it has acceded to. 3. For the purpose of paragraph 1, the following shall be considered sufficient proof of the existence of a valid UN type-approval: (a) for whole vehicles, a valid UN Declaration of Conformance certifying compliance with a U-IWVTA; (b) for equipment and parts, a valid UN type-approval mark affixed to the product; or (c) for equipment and parts to which a UN type-approval mark cannot be affixed, a valid UN type-approval certificate. 4. For the purpose of conducting market surveillance, the competent authorities of a Party may verify that the products covered comply, as appropriate, with (a) all the domestic technical regulations of that Party; or (b) the UN Regulations with which compliance has been attested, in accordance with this Article, by a valid UN Declaration of Conformance certifying compliance with a U-IWVTA in the case of whole vehicles, or by a valid UN type-approval mark affixed to the product or a valid UN type-approval certificate in the case of equipment and parts. Such verifications shall be carried out by random sampling in the market and in accordance with the technical regulations referred to in point (a) or (b) of this paragraph, as the case may be. 5. The Parties shall endeavour to cooperate in the field of market surveillance to support the identification and addressing of non-conformities of vehicles, systems, components or separate technical units. 6. A Party may take any appropriate measures with respect to vehicles, systems, components or separate technical units that present a serious risk to the health or safety of persons or with regard to other aspects of the protection of public interests, or that otherwise do not comply with applicable requirements. Such measures may include prohibiting or restricting the making available on the market, the registration or the entry into service of the vehicles, systems, components or separate technical units concerned, or withdrawing them from the market or recalling them. A Party that adopts or maintains such measures shall promptly inform the other Party of those measures and, at the request of the other Party, shall provide its reasons for adopting those measures. Article 7 Products with new technologies or new features 1. Neither Party shall refuse or restrict the access to its market of a product that is covered by this Annex and that has been approved by the exporting Party on the grounds that the product incorporates a new technology or a new feature that the importing Party has not yet regulated, unless it can demonstrate that it has reasonable grounds for believing that the new technology or new feature creates a risk for human health, safety or the environment. 2. If a Party decides to refuse the access to its market or requires the withdrawal from its market of a product of the other Party covered by this Annex on the grounds that it incorporates a new technology or a new feature creating a risk for human health, safety or the environment, it shall promptly notify that decision to the other Party and to the economic operator or operators concerned. The notification shall include all relevant scientific or technical information taken into account in the decision. Article 8 Cooperation 1. In order to further facilitate trade in motor vehicles, their parts and equipment, and to prevent market access problems, while ensuring human health, safety and environmental protection, the Parties shall endeavour to cooperate and to exchange information as appropriate. 2. Areas of cooperation under this Article may include in particular: (a) the development and establishment of technical regulations or related standards; (b) the exchange, to the extent possible, of research, information and results linked to the development of new vehicle safety regulations or related standards, advanced emission reduction, and emerging vehicle technologies; (c) the exchange of available information on the identification of safety-related or emission-related defects and non-compliance with technical regulations; and (d) the promotion of greater international harmonisation of technical requirements through multilateral fora, such as the 1958 Agreement and the 1998 Agreement, including through cooperation in the planning of initiatives in support of such harmonisation. Article 9 Working Group on Motor Vehicles and Parts 1. A Working Group on Motor Vehicles and Parts shall assist the Trade Specialised Committee on Technical Barriers to Trade in monitoring and reviewing the implementation of this Annex and ensuring its proper functioning. 2. The functions of the Working Group on Motor Vehicles and Parts shall be the following: (a) discussing any matter arising under this Annex, on request of a Party; (b) facilitating cooperation and exchange of information in accordance with Article 8; (c) carrying out technical discussions in accordance with Article 97 of this Agreement on matters falling within the scope of this Annex; and (d) maintaining a list of contact points responsible for matters arising under this Annex. (1) ECE/TRANS/WP.29/78/Rev.6 of 11 July 2017. ANNEX 12 MEDICINAL PRODUCTS Article 1 Definitions For the purposes of this Annex, the following definitions apply: (a) \"authority\" means an authority of a Party as listed in Appendix 12-A; (b) \"Good Manufacturing Practice\" or \"GMP\" means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications, as listed in Appendix 12-B; (c) \"inspection\" means an evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with Good Manufacturing Practice and/or commitments made as part of the approval to market a product, which is conducted in accordance with the laws, regulations and administrative provisions of the relevant Party, and includes pre-marketing and post-marketing inspection; (d) \"official GMP document\" means a document issued by an authority of a Party following the inspection of a manufacturing facility, including, for example, inspection reports, certificates attesting the compliance of a manufacturing facility with GMP, or a GMP non-compliance statement. Article 2 Scope The provisions of this Annex apply to medicinal products as listed in Appendix 12-C. Article 3 Objectives With regard to the products covered, the objectives of this Annex are: (a) to facilitate the availability of medicines in each Party\u2019s territory; (b) to set out the conditions for the recognition of inspections and for the exchange and acceptance of official GMP documents between the Parties; (c) to promote public health by safeguarding patient safety and animal health and welfare, as well as to protect high levels of consumer and environmental protection, where relevant, by promoting regulatory approaches in line with the relevant international standards. Article 4 International standards The relevant standards for the products covered by this Annex shall ensure a high level of protection of public health in line with standards, practices and guidelines developed by the World Health Organization (WHO), the Organization for Economic Cooperation and Development (OECD), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). Article 5 Recognition of inspections and acceptance of official GMP documents 1. A Party shall recognise inspections carried out by the other Party and shall accept official GMP documents issued by the other Party in accordance with the laws, regulations and technical guidelines listed in Appendix 12-B. 2. An authority of a Party may in specific circumstances opt not to accept an official GMP document issued by an authority of the other Party for manufacturing facilities located in the territory of the issuing authority. Examples of such circumstances include the indication of material inconsistencies or inadequacies in an inspection report, quality defects identified in post-market surveillance or other specific evidence of serious concern in relation to product quality or patient safety. Each Party shall ensure that where an authority of a Party opts not to accept an official GMP document issued by an authority of the other Party, that authority notifies the relevant authority of the other Party of the reasons for not accepting the document and may request clarification from the authority of the other Party. The relevant Party shall ensure that its authority endeavours to respond to the request for clarification in a timely manner. 3. A Party may accept official GMP documents issued by an authority of the other Party for manufacturing facilities located outside the territory of the issuing authority. 4. Each Party may determine the terms and conditions under which it accepts official GMP documents issued under paragraph 3. Article 6 Exchange of official GMP documents 1. Each Party shall ensure that if an authority of a Party requests an official GMP document from the authority of the other Party, the authority of the other Party shall endeavour to transmit the document within 30 calendar days of the date of the request. 2. Each Party shall treat the information in a document obtained pursuant to paragraph 1 as confidential. Article 7 Safeguards 1. Each Party has the right to conduct its own inspection of manufacturing facilities that have been certified as compliant by the other Party. 2. Each Party shall ensure that, prior to conducting an inspection under paragraph 1, the authority of the Party that intends to conduct the inspection notifies the relevant authority of the other Party of the inspection in writing, stating the reasons for conducting its own inspection. The authority of the Party that intends to conduct the inspection shall endeavour to notify the authority of the other Party in writing at least 30 days before a proposed inspection, but may provide a shorter notice in urgent situations. The authority of the other Party may join the inspection. Article 8 Changes to applicable laws and regulations 1. Each Party shall notify the other Party at least 60 days before adopting any new measures or changes relating to Good Manufacturing Practice concerning any of the relevant laws, regulations and technical guidelines listed in Appendix 12-B. 2. The Parties shall exchange all the necessary information, including changes to their respective laws, regulations, technical guidelines or inspection procedures relating to Good Manufacturing Practice so that each Party can consider whether the conditions for the recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1) continue to exist. 3. If as a result of any of the new measures or changes referred to in paragraph 1 of this Article, a Party considers that it can no longer recognise inspections or accept official GMP documents issued by the other Party, it shall notify the other Party of its intention to apply Article 9 and the Parties shall enter into consultations within the Working Group on Medicinal Products. 4. Any notification under this Article shall be done via the designated contact points in the Working Group on Medicinal Products. Article 9 Suspension 1. Without prejudice to Article 5(2), each Party has the right to suspend totally or partially the recognition of inspections and acceptance of official GMP documents of the other Party pursuant to Article 5(1) for all or some of the products listed in Appendix 12-C. That right shall be exercised in an objective and reasoned manner. The Party exercising such right shall notify the other Party and provide a written justification. A Party shall continue to accept official GMP documents of the other Party issued prior to such suspension, unless the Party decides otherwise on the basis of health or safety considerations. 2. Where, following consultations referred to in Article 8(3), a Party nevertheless suspends the recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1), it may do so in accordance with paragraph 1 of this Article not earlier than 60 days after the commencement of the consultations. During that 60-day period, both Parties shall continue to recognise inspections and accept official GMP documents issued by an authority of the other Party. 3. Where recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1) is suspended, at the request of a Party, the Parties shall discuss the matter within the Working Group on Medicinal Products and they shall make every effort to consider possible measures that would enable the recognition of inspections and acceptance of official GMP documents to be restored. Article 10 Regulatory cooperation 1. The Parties shall endeavour to consult one another, as permitted by their respective law, on proposals to introduce significant changes to technical regulations or inspection procedures, including those that affect how documents from the other Party are recognised in accordance with Article 5 and, where appropriate, to provide the opportunity to comment on such proposals, without prejudice to Article 8. 2. The Parties shall endeavour to cooperate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines including, where feasible, through the presentation of joint initiatives, proposals and approaches in the relevant international organisations and bodies referred to in Article 4. Article 11 Amendments to appendices The Partnership Council shall have the power to amend Appendix 12-A in order to update the list of authorities, Appendix 12-B in order to update the list of applicable laws, regulations and technical guidelines, and Appendix 12-C in order to update the list of covered products. Article 12 Working Group on Medicinal Products 1. The Working Group on Medicinal Products shall assist the Trade Specialised Committee on Technical Barriers to Trade in monitoring and reviewing the implementation of this Annex and ensuring its proper functioning. 2. The functions of the Working Group on Medicinal Products shall be the following: (a) discussing any matter arising under this Annex at the request of a Party; (b) facilitating cooperation and exchanges of information for the purposes of Articles 8 and 10; (c) functioning as the forum for consultations and discussions for the purposes of Articles 8(3) and 9(3); (d) carrying out technical discussions in accordance with Article 97 of this Agreement on matters falling within the scope of this Annex; and (e) maintaining a list of contact points responsible for matters arising under this Annex. Article 13 Non-application of dispute settlement Title I of Part Six of this Agreement does not apply in respect of disputes regarding the interpretation and application of this Annex. Appendix 12-A AUTHORITIES OF THE PARTIES (1) European Union: Country For medicinal products for human use For medicinal products for veterinary use Belgium Federal agency for medicines and health products / Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence f\u00e9d\u00e9rale des m\u00e9dicaments et produits de sant\u00e9 See authority for medicinal products for human use Bulgaria Bulgarian Drug Agency / \u0418\u0417\u041f\u042a\u041b\u041d\u0418\u0422\u0415\u041b\u041d\u0410 \u0410\u0413\u0415\u041d\u0426\u0418\u042f \u041f\u041e \u041b\u0415\u041a\u0410\u0420\u0421\u0422\u0412\u0410\u0422\u0410 Bulgarian Food Safety Agency / \u0411\u044a\u043b\u0433\u0430\u0440\u0441\u043a\u0430 \u0430\u0433\u0435\u043d\u0446\u0438\u044f \u043f\u043e \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442 \u043d\u0430 \u0445\u0440\u0430\u043d\u0438\u0442\u0435 Czechia State Institute for Drug Control / St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div (S\u00daKL) Institute for State Control of Veterinary Biologicals and Medicaments / \u00dastav pro st\u00e1tn\u00ed kontrolu veterin\u00e1rn\u00edch bioprepar\u00e1t\u016f a l\u00e9\u010div (\u00daSKVBL) Denmark Danish Medicines Agency / Laegemiddelstyrelsen See authority for medicinal products for human use Germany Federal Institute for Drugs and Medical Devices / Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte (BfArM) Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines / Paul-Ehrlich-Institut (PEI) Bundesinstitut f\u00fcr Impfstoffe und biomedizinische Arzneimittel Federal Ministry of Health / Bundesministerium f\u00fcr Gesundheit (BMG) / Zentralstelle der L\u00e4nder f\u00fcr Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (1) Federal Office for Consumer Protection and Food Safety / Bundesamt f\u00fcr Verbraucherschutz und Lebensmittelsicherheit (BVL) Federal Ministry of Food and Agriculture, Bundesministerium f\u00fcr Ern\u00e4hrung und Landwirtschaft Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines / Paul-Ehrlich-Institut (PEI) Bundesinstitut f\u00fcr Impfstoffe und biomedizinische Arzneimittel Estonia State Agency of Medicines / Ravimiamet See authority for medicinal products for human use Ireland Health Products Regulatory Authority (HPRA) See authority for medicinal products for human use Greece National Organisation for Medicines / Ethnikos Organismos Farmakon (EOF) - (\u0395\u0398\u039dI\u039a\u039f\u03a3 \u039f\u03a1\u0393\u0391\u039dI\u03a3\u039c\u039f\u03a3 \u03a6\u0391\u03a1\u039c\u0391\u039a\u03a9\u039d) See authority for medicinal products for human use Spain Spanish Agency of Medicines and Medical Devices / Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (2) See authority for medicinal products for human use France French National Agency for Medicines and Health Products Safety Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) French agency for food, environmental and occupational health safety-National Agency for Veterinary Medicinal Products / Agence Nationale de S\u00e9curit\u00e9 Sanitaire de l\u2019alimentation, de l\u2019environnement et du travail-Agence Nationale du M\u00e9dicament V\u00e9t\u00e9rinaire (Anses-ANMV) Croatia Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED) Ministry of Agriculture, Veterinary and Food Safety Directorate / Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane Italy Italian Medicines Agency / Agenzia Italiana del Farmaco Direction General for Animal Health and Veterinary Medicinal Products / Ministero della Salute, Direzione Generale della Sanit\u00e0 Animale e dei Farmaci Veterinari Cyprus Ministry of Health - Pharmaceutical Services / \u03a6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03ad\u03c2 \u03a5\u03c0\u03b7\u03c1\u03b5\u03c3\u03af\u03b5\u03c2, \u03a5\u03c0\u03bf\u03c5\u03c1\u03b3\u03b5\u03af\u03bf \u03a5\u03b3\u03b5\u03af\u03b1\u03c2 Ministry of Agriculture, Rural Development and Environment- Veterinary Services / \u039a\u03c4\u03b7\u03bd\u03b9\u03b1\u03c4\u03c1\u03b9\u03ba\u03ad\u03c2 \u03a5\u03c0\u03b7\u03c1\u03b5\u03c3\u03af\u03b5\u03c2- \u03a5\u03c0\u03bf\u03c5\u03c1\u03b3\u03b5\u03af\u03bf \u0393\u03b5\u03c9\u03c1\u03b3\u03af\u03b1\u03c2, \u0391\u03b3\u03c1\u03bf\u03c4\u03b9\u03ba\u03ae\u03c2 \u0391\u03bd\u03ac\u03c0\u03c4\u03c5\u03be\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03a0\u03b5\u03c1\u03b9\u03b2\u03ac\u03bb\u03bb\u03bf\u03bd\u03c4\u03bf\u03c2 Latvia State Agency of Medicines / Z\u0101\u013cu valsts a\u0123ent\u016bra Assessment and Registration Department of the Food and Veterinary Service / P\u0101rtikas un veterin\u0101r\u0101 dienesta Nov\u0113rt\u0113\u0161anas un re\u0123istr\u0101cijas departaments Lithuania State Medicines Control Agency / Valstybin\u0117 vaist\u0173 kontrol\u0117s tarnyba State Food and Veterinary Service / Valstybin\u0117 maisto ir veterinarijos tarnyba Luxembourg Min\u00ecstere de la Sant\u00e9, Division de la Pharmacie et des M\u00e9dicaments See authority for medicinal products for human use Hungary Orsz\u00e1gos Gy\u00f3gyszer\u00e9szeti \u00e9s \u00c9lelmez\u00e9s-eg\u00e9szs\u00e9g\u00fcgyi Int\u00e9zet / National Institute of Pharmacy and Nutrition National Food Chain Safety Office, Directorate of Veterinary Medicinal Products / Nemzeti \u00c9lelmiszerl\u00e1nc-biztons\u00e1gi Hivatal, \u00c1llatgy\u00f3gy\u00e1szati Term\u00e9kek Igazgat\u00f3s\u00e1ga (\u00c1TI) Malta Medicines Regulatory Authority Veterinary Medicines Section of the National Veterinary Laboratory (NVL) within The Animal Health and Welfare Department (AHWD) Netherlands Healthcare and Youth Inspectorate / Inspectie Gezondheidszorg en Youth (IGJ) Medicines Evaluation Board / Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG) Austria Austrian Agency for Health and Food Safety / \u00d6sterreichische Agentur f\u00fcr Gesundheit und Ern\u00e4hrungssicherheit GmbH See authority for medicinal products for human use Poland The Main Pharmaceutical Inspectorate / G\u0142\u00f3wny Inspektorat Farmaceutyczny (GIF) See authority medicinal products for human use Portugal National Authority of Medicines and Health Products / INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Sa\u00fade, I.P General Directorate of Food and Veterinary / DGAV - Dire\u00e7\u00e3o Geral de Alimenta\u00e7\u00e3o e Veterin\u00e1ria (PT) Romania National Agency for Medicines and Medical Devices / Agen\u0163ia Na\u0163ional\u0103 a Medicamentului \u015fi a Dispozitivelor Medicale National Sanitary Veterinary and Food Safety Authority / Autoritatea Na\u0163ional\u0103 Sanitar\u0103 Veterinar\u0103 \u015fi pentru Siguran\u0163a Alimentelor Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia / Javna agencija Republike Slovenije za zdravila in medicinske pripomo\u010dke (JAZMP) See authority for medicinal products for human use Slovakia State Institute for Drug Control / \u0160t\u00e1tny \u00fastav pre kontrolu lie\u010div (\u0160\u00daKL) Institute for State Control of Veterinary Biologicals and Medicaments / \u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a lie\u010div (\u00da\u0160KVBL) Finland Finnish Medicines Agency / L\u00e4\u00e4kealan turvallisuus- ja kehitt\u00e4miskeskus (FIMEA) See authority for medicinal products for human use Sweden Medical Products Agency / L\u00e4kemedelsverket See authority for medicinal products for human use (2) United Kingdom Medicines and Healthcare Products Regulatory Agency Veterinary Medicines Directorate Appendix 12-B LIST OF APPLICABLE LAWS, REGULATIONS AND TECHNICAL GUIDELINES RELATING TO GOOD MANUFACTURING PRACTICE (1) For the European Union: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3); Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (4); Directive 2001/20/EC of European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (5); Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (6); Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (7); Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (8); Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (9); Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (10); Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (11); Commission Delegated Regulation (EU) 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (12); Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (13); Current version of the Guide to good manufacturing practice contained in volume IV of Rules governing medicinal products in the European Union and compilation of the community procedures on inspections and exchange of information. (2) For the United Kingdom: The Human Medicines Regulations 2012 (SI 2012/1916) The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) The Veterinary Medicines Regulations 2013 (SI 2013/2033) Regulations on good manufacturing practice made under regulation B17, and guidelines on good manufacturing practice published pursuant to regulation C17, of the Human Medicines Regulations 2012 The principles and guidelines on good manufacturing practice applicable for the purposes of Schedule 2 to the Veterinary Medicines Regulations 2013 Appendix 12-C COVERED PRODUCTS Medicinal products for human use and veterinary use: \u2014 marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use, \u2014 advanced therapy medicinal products, \u2014 active pharmaceutical ingredients for human or veterinary use, \u2014 investigational medicinal products. (1) For the purpose of this Annex, and without prejudice to the internal division of competence in Germany on matters falling within the scope of this Annex, ZLG shall be understood as covering all the competent L\u00e4nder authorities issuing GMP documents and conducting pharmaceutical inspections. (2) For the purpose of this Annex, and without prejudice to the internal division of competence in Spain on matters falling within the scope of this Annex, Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios shall be understood as covering all the competent regional authorities issuing official GMP documents and conducting pharmaceutical inspections. (3) OJ EU L 311, 28.11.2001, p. 67. (4) OJ EU L 311, 28.11.2001, p. 1. (5) OJ EU L 121, 1.5.2001, p. 34. (6) OJ EU L 158, 27.5.2014, p. 1. (7) OJ EU L 136, 30.4.2004, p. 1. (8) OJ EU L 324, 10.12.2007, p. 121. (9) OJ EU L 262, 14.10.2003, p. 22. (10) OJ EU L 228, 17.8.1991, p. 70. (11) OJ EU L 238, 16.9.2017, p. 44. (12) OJ EU L 337, 25.11.2014, p. 1. (13) OJ EU L 238, 16.9.2017, p. 12. ANNEX 13 CHEMICALS Article 1 Definitions For the purposes of this Annex, the following definitions apply: (a) \"responsible authorities\" means: (i) for the Union: the European Commission; (ii) for the United Kingdom: the government of the United Kingdom; (b) \"UN GHS\" means the United Nations Globally Harmonized System of Classification and Labelling of Chemicals. Article 2 Scope This Annex applies to the trade, regulation, import and export of chemicals between the Union and the United Kingdom in respect of their registration, evaluation, authorisation, restriction, approval, classification, labelling and packaging. Article 3 Objectives 1. The objectives of this Annex are to: (a) facilitate the trade of chemicals and related products between the Parties; (b) ensure high levels of protection for the environment, and human and animal health; and (c) provide for cooperation between Union and United Kingdom responsible authorities. 2. The Parties acknowledge that the commitments made under this Annex do not prevent either Party from setting its own priorities on chemicals regulation, including establishing its own levels of protection in respect of the environment, and human and animal health. Article 4 Relevant international organisations and bodies The Parties recognise that international organisations and bodies, in particular the OECD and the Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (SCEGHS) of the United Nations Economic and Social Council (ECOSOC), are relevant for developing scientific and technical guidelines with respect to chemicals. Article 5 Participation in relevant international organisations and bodies and regulatory developments 1. The Parties shall actively contribute to the development of the scientific or technical guidelines referred to in Article 4 with respect to the assessment of hazards and risks of chemicals and the formats for documenting the results of such assessments. 2. Each Party shall implement any guidelines issued by the international organisations and bodies referred to in Article 4, unless those guidelines would be ineffective or inappropriate for the achievement of that Party\u2019s legitimate objectives. Article 6 Classification and labelling of chemicals 1. Each Party shall implement the UN GHS as comprehensively as it considers feasible within its respective system, including for chemicals that are not within the scope of this Annex, except where there are specific reasons to apply a different labelling system for particular chemical products in their finished state intended for the final user. Each Party shall periodically update its implementation based on the regularly issued revisions of the UN GHS. 2. Where the responsible authority of a Party intends to classify individual substances in accordance with its respective rules and procedures, it shall give the responsible authority of the other Party the possibility of expressing its views in accordance with those respective rules and procedures within the applicable timelines. 3. Each Party shall make information about its procedures related to the classification of substances publicly available in accordance with its respective rules and procedures. Each Party shall endeavour to respond to comments received from the other Party pursuant to paragraph 2. 4. Nothing in this Article shall oblige either Party to achieve any particular outcome regarding the implementation of the UN GHS in its territory or regarding the classification of a given substance, or to advance, suspend or delay its respective procedures and decision-making processes. Article 7 Cooperation 1. The Parties recognise that voluntary cooperation on chemicals regulation can facilitate trade in ways that benefit consumers, businesses and the environment and that contribute to enhancing the protection of human and animal health. 2. The Parties commit to facilitating the exchange of non-confidential information between their responsible authorities, including through cooperation on electronic formats and tools used to store data. 3. The Parties shall cooperate where appropriate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines, including, where feasible, through the presentation of joint initiatives, proposals and approaches in the relevant international organisations and bodies, in particular those referred to in Article 4. 4. The Parties shall cooperate, if considered beneficial by both Parties, with regard to the dissemination of data related to chemicals safety, and shall make such information available to the public with the objective of ensuring easy access to and the comprehensibility of that information by different target groups. Upon request of either Party, the other Party shall provide available non-confidential information on chemicals safety to the requesting Party. 5. If a Party so requests and the other Party agrees to do so, the Parties shall enter into consultations on scientific information and data in the context of new and emerging issues related to the hazards or risks posed by chemicals to human health or the environment, with a view to creating a common pool of knowledge and, if feasible and to the extent possible, promoting a common understanding of the science related to such issues. Article 8 Information exchange The Parties shall cooperate and exchange information with respect to any issue relevant for the implementation of this Annex within the Trade Specialised Committee on Technical Barriers to Trade. ANNEX 14 ORGANIC PRODUCTS Article 1 Objective and scope 1. The objective of this Annex is to set out the provisions and procedures for fostering trade in organic products in accordance with the principles of non-discrimination and reciprocity, by means of the recognition of equivalence by the Parties of their respective laws. 2. This Annex applies to the organic products listed in Appendices 14-A and 14-B which comply with the laws and regulations listed in Appendix 14-C or 14-D. The Partnership Council shall have the power to amend Appendices 14-A, 14-B, 14-C and 14-D. Article 2 Definitions For the purposes of this Annex, the following definitions apply: (a) \"competent authority\" means an official agency that has jurisdiction over the laws and regulations listed in Appendix 14-C or 14-D and is responsible for the implementation of this Annex; (b) \"control authority\" means an authority on which the competent authority has conferred, in whole or in part, its competence for inspections and certifications in the field of organic production in accordance with the laws and regulations listed in Appendix 14-C or 14-D; (c) \"control body\" means an entity recognised by the competent authority to carry out inspections and certifications in the field of organic production in accordance with the laws and regulations listed in Appendix 14-C or 14-D; and (d) \"equivalence\" means the capability of different laws, regulations and requirements, as well as inspection and certification systems, of meeting the same objectives. Article 3 Recognition of equivalence 1. With respect to products listed in Appendix 14-A, the Union shall recognise the laws and regulations of the United Kingdom listed in Appendix 14-C as equivalent to the Union's laws and regulations listed in Appendix 14-D. 2. With respect to products listed in Appendix 14-B, the United Kingdom shall recognise the laws and regulations of the Union listed in Appendix 14-D as equivalent to the United Kingdom's laws and regulations listed in Appendix 14-C. 3. In view of the date of application of 1 January 2022 of Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007, the recognition of equivalence referred to in paragraphs 1 and 2 shall be reassessed by each Party by 31 December 2023. If, as a result of that reassessment, equivalence is not confirmed by a Party, recognition of equivalence shall be suspended. 4. Without prejudice to paragraph 3, in the event of the modification, revocation or replacement of the laws and regulations listed in Appendix 14-C or 14-D, the new rules shall be considered equivalent to the other Party\u2019s rules unless a Party objects in accordance with the procedure set out in paragraphs 5 and 6. 5. If, following the receipt of further information from the other Party that it has requested, a Party considers that the laws, regulations or administrative procedures or practices of the other Party no longer meet the requirements for equivalence, that Party shall issue a reasoned request to the other Party to amend the relevant laws, regulations or administrative procedures or practices, and shall provide the other Party with an adequate period, which shall not be less than three months, for ensuring equivalence. 6. If, following the expiry of the period in paragraph 5, the Party concerned still considers that the requirements for equivalence are not met, it may take a decision to unilaterally suspend the recognition of equivalence of the relevant laws and regulations listed in Appendix 14-C or 14-D, as regards the relevant organic products listed in Appendix 14-A or 14-B. 7. A decision to unilaterally suspend the recognition of equivalence of the laws and regulations listed in Appendix 14-C or 14-D, as regards the relevant organic products listed in Appendix 14-A or 14-B may also be taken, following the expiry of a notice period of three months, where a Party has not provided the information required under Article 6 or does not agree to a peer review under Article 7. 8. Where recognition of equivalence is suspended in accordance with this Article, the Parties shall, at the request of a Party, discuss the matter within the Working Group on Organic Products and they shall make every effort to consider possible measures that would enable recognition of equivalence to be restored. 9. With respect to products not listed in Appendix 14-A or 14-B, equivalence shall be discussed by the Working Group on Organic Products at the request of a Party. Article 4 Import and placing on the market 1. The Union shall accept the import into its territory of the products listed in Appendix 14-A, and the placing of those products on the market as organic products, provided that those products comply with the laws and regulations of the United Kingdom listed in Appendix 14-C and are accompanied by a certificate of inspection issued by a control body recognised by the United Kingdom and indicated to the Union as referred to in paragraph 3. 2. The United Kingdom shall accept the import into its territory of the products listed in Appendix 14-B, and the placing of those products on the market as organic products, provided that those products comply with the laws and regulations of the Union listed in Appendix 14-D and are accompanied by a certificate of inspection issued by a control body recognised by the Union and indicated to the United Kingdom as referred to in paragraph 3. 3. Each Party recognises the control authorities or control bodies indicated by the other Party as responsible for performing the relevant controls as regards organic products covered by the recognition of equivalence as referred to in Article 3 and for issuing the certificate of inspection as referred to in paragraphs 1 and 2 of this Article with a view to their import into and placing on the market in the territory of the other Party. 4. The importing Party, in cooperation with the other Party, shall assign code numbers to each relevant control authority and control body indicated by the other Party. Article 5 Labelling 1. Products imported into the territory of a Party in accordance with this Annex shall meet the requirements for labelling set out in the laws and regulations of the importing Party listed in Appendices 14-C and 14-D. Those products may bear the Union\u2019s organic logo, any United Kingdom organic logo or both logos, as set out in the relevant laws and regulations, provided that those products comply with the labelling requirements for the respective logo or both logos. 2. The Parties undertake to avoid any misuse of the terms referring to organic production in relation to organic products that are covered by the recognition of equivalence under this Annex. 3. The Parties undertake to protect the Union\u2019s organic logo and any United Kingdom organic logo set out in the relevant laws and regulations against any misuse or imitation. The Parties shall ensure that the Union\u2019s organic logo and any United Kingdom organic logo are used only for the labelling, advertising or commercial documents of organic products that comply with the laws and regulations listed in Appendices 14-C and 14-D. Article 6 Exchange of information 1. The Parties shall exchange all relevant information with respect to the implementation and application of this Annex. In particular, by 31 March of the second year following the entry into force of this Agreement, and by 31 March of each following year, each Party shall send to the other: (a) a report that contains information with respect to the types and quantities of organic products exported under this Annex, covering the period from January to December of the previous year; (b) a report on the monitoring and supervisory activities carried out by its competent authorities, the results obtained, and the corrective measures taken, covering the period from January to December of the previous year; and (c) details of observed irregularities and infringements of the laws and regulations listed in Appendix 14-C or 14-D, as relevant. 2. Each Party shall inform the other Party without delay of: (a) any update to the list of its competent authorities, control authorities and control bodies, including the relevant contact details (in particular the address and the internet address); (b) any changes or repeals it intends to make in respect of laws or regulations listed in Appendix 14-C or Appendix 14-D, any proposals for new laws or regulations or any relevant proposed changes to administrative procedures and practices related to organic products covered by this Annex; and (c) any changes or repeals it has adopted in respect of laws or regulations listed in Appendix 14-C or Appendix 14-D, any new legislation or relevant changes to administrative procedures and practices related to organic products covered by this Annex. Article 7 Peer reviews 1. Following advance notice of at least six months, each Party shall permit officials or experts designated by the other Party to conduct peer reviews in its territory to verify that the relevant control authorities and control bodies are carrying out the controls required to implement this Annex. 2. Each Party shall cooperate with and assist the other Party, to the extent permitted under the applicable law, in carrying out the peer reviews referred to in paragraph 1, which may include visits to offices of relevant control authorities and control bodies, processing facilities and certified operators. Article 8 Working Group on Organic Products 1. The Working Group on Organic Products shall assist the Trade Specialised Committee on Technical Barriers to Trade in monitoring and reviewing the implementation of this Annex and ensuring its proper functioning. 2. The functions of the Working Group on Organic Products shall be the following: (a) discussing any matter arising under this Annex at the request of a Party, including any possible need for amendments to this Annex or any of its Appendices; (b) facilitating cooperation regarding laws, regulations, standards and procedures concerning the organic products covered by this Annex, including discussions on any technical or regulatory issue related to rules and control systems; and (c) carrying out technical discussions in accordance with Article 97 of this Agreement on matters falling within the scope of this Annex. Appendix 14-A ORGANIC PRODUCTS FROM THE UNITED KINGDOM FOR WHICH THE UNION RECOGNISES EQUIVALENCE Description Comments Unprocessed plant products Live animals or unprocessed animal products Includes Honey Aquaculture products and seaweeds Processed agricultural products for use as food Processed agricultural products for use as feed Seeds and propagating material The organic products listed in this Appendix shall be unprocessed agricultural or aquaculture products produced in the United Kingdom or processed agricultural products for use as food or feed that have been processed in the United Kingdom with ingredients that have been grown in the United Kingdom or that have been imported into the United Kingdom in accordance with United Kingdom laws and regulations. Appendix 14-B ORGANIC PRODUCTS FROM THE UNION FOR WHICH THE UNITED KINGDOM RECOGNISES EQUIVALENCE Description Comments Unprocessed plant products Live animals or unprocessed animal products Includes Honey Aquaculture products and seaweeds Processed agricultural products for use as food Processed agricultural products for use as feed Seeds and propagating material The organic products listed in this Appendix shall be unprocessed agricultural or aquaculture products produced in the Union or processed agricultural products for use as food or feed that have been processed in the Union with ingredients that have been grown in the Union or that have been imported into the Union in accordance with the Union laws and regulations. Appendix 14-C LAWS AND REGULATIONS ON ORGANIC PRODUCTS APPLICABLE IN THE UNITED KINGDOM (1) The following laws and regulations are applicable in the United Kingdom: 1. Retained Regulation (EC) No 834/2007 2. Retained Regulation (EC) No 889/2008 3. Retained Regulation (EC) No 1235/2008 4. The Organic Products Regulations 2009 (SI 2009/842) Appendix 14-D LAWS AND REGULATIONS ON ORGANIC PRODUCTS APPLICABLE IN THE UNION The following laws and regulations are applicable in the Union: 1. Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (2) 2. Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (3) 3. Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (4) (1) References in this list to Retained Union law are deemed to be references to such legislation, as amended by the United Kingdom to apply to the United Kingdom. (2) OJ EU L 189, 20.7.2007, p. 1. (3) OJ EU L 250, 18.9.2008, p. 1. (4) OJ EU L 334, 12.12.2008, p. 25. ANNEX 15 TRADE IN WINE Article 1 Scope and definitions 1. This Annex applies to wine falling under heading 22.04 of the Harmonised System. 2. For the purposes of this Annex, \"wine produced in\" means fresh grapes, grape must and grape must in fermentation that have been turned into wine or added to wine in the territory of the exporting Party. Article 2 Product definitions, oenological practices and processes 1. Oenological practices for wine recommended and published by the International Organisation of the Vine and Wine (\"OIV\") shall be considered relevant international standards for the purposes of this Annex. 2. Each Party shall authorise the importation and sale for consumption of wine produced in the other Party, if that wine has been produced in accordance with: (a) product definitions authorised in each Party under the laws and regulations referred to in Appendix 15-A; (b) the oenological practices established in each Party under the laws and regulations referred to in Appendix 15-A that are in accordance with the relevant OIV standards; and (c) oenological practices and restrictions established in each Party that are not in accordance with the relevant OIV standards, listed in Appendix 15-B. 3. The Partnership Council shall have the power to amend the Appendices referred to in paragraph 2. Article 3 Certification requirements on import in the respective territories of the Parties 1. For wine produced in a Party and placed on the market in the other Party, the documentation and certification that may be required by either Party shall be limited to a certificate, as set out in Appendix 15-C, authenticated in conformity with the exporting Party\u2019s laws and regulations. 2. A certificate required under paragraph 1 may take the form of an electronic document. Access to the electronic document or to the data necessary for its establishment shall be given by each Party on request of the competent authorities of the other Party where the goods are to be released into free circulation. If access to the relevant electronic systems is not available, the necessary data may also be requested in the form of a paper document. 3. The Partnership Council shall have the power to amend Appendix 15-C. 4. The methods of analysis recognised as reference methods by the OIV and published by the OIV shall be the reference methods for the determination of the analytical composition of the wine in the context of control operations. Article 4 Food information and lot codes 1. Unless otherwise specified in this Article, labelling of wine imported and marketed under this Agreement shall be conducted in compliance with the laws and regulations that apply in the territory of the importing Party. 2. A Party shall not require any of the following dates or their equivalent to appear on the container, label, or packaging of wine: (a) the date of packaging; (b) the date of bottling; (c) the date of production or manufacture; (d) the date of expiration, use by date, use or consume by date, expire by date; (e) the date of minimum durability, best-by-date, best quality before date; or (f) the sell-by-date. By way of derogation from point (e) of the first subparagraph, a Party may require the display of a date of minimum durability on products that on account of the addition of perishable ingredients could have a shorter date of minimum durability than would normally be expected by the consumer. 3. Each Party shall ensure that a code is indicated on the label of packaged products that allows for the identification of the lot to which the product belongs, in accordance with the legislation of the Party exporting the packaged product. The lot code shall be easily visible, clearly legible and indelible. A Party shall not allow the marketing of packaged products which do not comply with the requirements set out in this paragraph. 4. Each Party shall permit mandatory information, including translations or an indication of the number of standard drinks or alcohol units whenever required, to be displayed on a supplementary label affixed to a wine container. Supplementary labels may be affixed to a wine container after importation but prior to the product being placed on the market in the Party's territory, provided that the mandatory information is fully and accurately displayed. 5. The importing Party shall not require the display on the label of allergens which have been used in the production of wine but are not present in the final product. Article 5 Transitional measures Wine which, at the date of entry into force of this Agreement, has been produced, described and labelled in accordance with the laws and regulations of a Party but in a manner that does not comply with this Annex, may continue to be labelled and placed on the market as follows: (a) by wholesalers or producers, for a period of two years from the entry into force of this Agreement; and (b) by retailers, until stocks are exhausted. Article 6 Information exchange The Parties shall cooperate and exchange information on any issue relevant for the implementation of this Annex within the Trade Specialised Committee on Technical Barriers to Trade. Article 7 Review No later than three years from the entry into force of this Agreement, the Parties shall consider further steps to facilitate trade in wine between the Parties. Appendix 15-A LAWS AND REGULATIONS OF THE PARTIES Laws and regulations of the United Kingdom (1) Laws and regulations referred to in Article 2(2) concerning: a) product definitions: (i) Retained Regulation (EU) No 1308/2013, in particular production rules in the wine sector, in accordance with Articles 75, 81 and 91, Part IV of Annex II and Part II of Annex VII to that Regulation and its implementing rules, including subsequent modifications; (ii) Retained Commission Delegated Regulation (EU) 2019/33, in particular Articles 47, 52 to 54 and Annexes III, V and VI to that Regulation, including subsequent modifications; (iii) Retained Regulation (EU) No 1169/2011, including subsequent modifications; b) oenological practices and restrictions: (i) Retained Regulation (EU) No 1308/2013, in particular oenological practices and restrictions in accordance with Articles 80 and 83 and Annex VIII to that Regulation and its implementing rules, including subsequent modifications; (ii) Retained Commission Delegated Regulation (EU) 2019/934, including subsequent modifications. Laws and regulations of the Union: Laws and regulations referred to in Article 2(2) concerning: a) product definitions: (i) Regulation (EU) No 1308/2013 of the European Parliament and of the Council (2), in particular production rules in the wine sector, in accordance with Articles 75, 81 and 91, Part IV of Annex II and Part II of Annex VII to that Regulation and its implementing rules, including subsequent modifications; (ii) Commission Delegated Regulation (EU) 2019/33 (3), in particular Articles 47, 52 to 54 and Annexes III, V and VI to that Regulation, including subsequent modifications; (iii) Regulation (EU) No 1169/2011 of the European Parliament and of the Council (4), including subsequent modifications. b) oenological practices and restrictions: (i) Regulation (EU) No 1308/2013, in particular oenological practices and restrictions in accordance with Articles 80 and 83 and Annex VIII to that Regulation and its implementing rules, including subsequent modifications; (ii) Commission Delegated Regulation (EU) 2019/934 (5), including subsequent modifications. Appendix 15-B ADDITIONAL OENOLOGICAL PRACTICES AND RESTRICTIONS JOINTLY ACCEPTED BY THE PARTIES (1) Concentrated grape must, rectified concentrated grape must and sucrose may be used for enrichment and sweetening under the specific and limited conditions set out in Part I of Annex VIII to Regulation (EU) No 1308/2013 and in Part I of Annex VIII to Retained Regulation (EU) No 1308/2013, subject to the exclusion of use of these products in a reconstituted form in wines covered by this Agreement. (2) The addition of water in winemaking is not allowed, except where required on account of a specific technical necessity. (3) Fresh lees may be used under the specific and limited conditions set out in line item 11.2 of Table 2 of Part A of Annex I to Commission Delegated Regulation (EU) 2019/934 and in line item 11.2 of Table 2 of Part A of Annex I to Retained Commission Delegated Regulation (EU) 2019/934. Appendix 15-C TEMPLATE FOR SELF-CERTIFICATE FOR WINE IMPORTED FROM THE [EUROPEAN UNION / UNITED KINGDOM] INTO THE [UNITED KINGDOM / EUROPEAN UNION](1) 1. Exporter (name and address) 2. Serial No(2) 3. Importer (name and address) 4. Competent authority at the place of dispatch in the [European Union / United Kingdom](3) 5. Customs stamp (for official [European Union / United Kingdom] use only) 6. Means of transport and transport details(4) 7. Place of unloading (if different from 3) 8. Description of the imported product(5) 9. Quantity in l/hl/kg 10. Number of containers(6) 11. Certificate The product described above is intended for direct human consumption and complies with the definitions and oenological practices authorised under Annex 15 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part. It has been produced by a producer who is subject to inspection and supervision by the following competent authority(7): Consignor certifying the above information(8) Identification of the consignor(9) Place, date and signature of the consignor (1) In accordance with Article 3(1) of Annex 15 to the Trade and Cooperation Agreement between the European Union European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part. (2) Indicate the traceability number of the consignment, i.e. a serial number that identifies the consignment in the records of the exporter. (3) Indicate full name, address and contact details of the competent authority in one of the Member States of the European Union or in the United Kingdom from which the consignment is exported that is responsible for verifying the information referred to in this certificate. (4) Indicate transport used for delivery to the point of entry into the European Union or the United Kingdom; specify transport mode (ship, airplane, etc.), give name of the means of transport (name of ship, number of flight, etc.). (5) Indicate the following information: \u2014 sale designation, as it appears on the label, \u2014 name of producer, \u2014 wine-growing region, \u2014 name of the country of production (one of the Member States of the European Union, or the United Kingdom), \u2014 name of the GI, if relevant, \u2014 total alcoholic strength by volume, \u2014 colour of the product (state \"red\", \"ros\u00e9\", \"pink\" or \"white\" only), \u2014 Combined Nomenclature code (CN code). (6) A container means a receptacle for wine of less than 60 litres. The number of containers may be the number of bottles. (7) Indicate full name, address and contact details of relevant competent authority in one of the Member States of the European Union or in the United Kingdom. (8) Indicate full name, address and contact details of the consignor. (9) Indicate: \u2014 For the European Union: the System of Exchange of Excise Data (SEED) excise number, or VAT number in case the consignor has no SEED number, or reference to the number in the list or register provided for in Article 8(3) of Commission Delegated Regulation (EU) 2018/273 (6); \u2014 For the United Kingdom: the System of Exchange of Excise Data (SEED) excise number, or VAT number in case the consignor has no SEED number, or reference to the WSB number. (1) References in this list to Retained Union law are deemed to be references to such legislation, as amended by the United Kingdom to apply to the United Kingdom. (2) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ EU L 347, 20.12.2013, p. 671). (3) Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards applications for protection of designations of origin, geographical indications and traditional terms in the wine sector, the objection procedure, restrictions of use, amendments to product specifications, cancellation of protection, and labelling and presentation (OJ EU L 9, 11.1.2019, p. 2). (4) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ EU L 304, 22.11.2011, p. 18). (5) Commission Delegated Regulation (EU) 2019/934 of 12 March 2019 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards wine-growing areas where the alcoholic strength may be increased, authorised oenological practices and restrictions applicable to the production and conservation of grapevine products, the minimum percentage of alcohol for by-products and their disposal, and publication of OIV files (OJ EU L 149, 7.6.2019, p. 1). (6) Commission Delegated Regulation (EU) 2018/273 of 11 December 2017 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the scheme of authorisations for vine plantings, the vineyard register, accompanying documents and certification, the inward and outward register, compulsory declarations, notifications and publication of notified information, and supplementing Regulation (EU) No 1306/2013 of the European Parliament and of the Council as regards the relevant checks and penalties, amending Commission Regulations (EC) No 555/2008, (EC) No 606/2009 and (EC) No 607/2009 and repealing Commission Regulation (EC) No 436/2009 and Commission Delegated Regulation (EU) 2015/560 (OJ EU L 58, 28.2.2018, p. 1). ANNEX 16 ARRANGEMENT REFERRED TO IN ARTICLE 96(4) FOR THE REGULAR EXCHANGE OF INFORMATION IN RELATION TO THE SAFETY OF NON-FOOD PRODUCTS AND RELATED PREVENTIVE, RESTRICTIVE AND CORRECTIVE MEASURES This Annex shall establish an arrangement for the regular exchange of information between the Union\u2019s Rapid Alert System for non-food products (RAPEX), or its successor, and the United Kingdom\u2019s database relating to market surveillance and product safety established under the General Product Safety Regulations 2005, or its successor. In accordance with Article 96(8) of this Agreement, the arrangement shall specify the type of information to be exchanged, the modalities for the exchange and the application of confidentiality and personal data protection rules. ANNEX 17 ARRANGEMENT REFERRED TO IN ARTICLE 96(5) FOR THE REGULAR EXCHANGE OF INFORMATION REGARDING MEASURES TAKEN ON NON-COMPLIANT NON-FOOD PRODUCTS, OTHER THAN THOSE COVERED BY ARTICLE 96(4) This Annex shall establish an arrangement for the regular exchange of information, including the exchange of information by electronic means, regarding measures taken on non-compliant non-food products, other than those covered by Article 96(4) of this Agreement. In accordance with Article 96(8) of this Agreement, the arrangement shall specify the type of information to be exchanged, the modalities for the exchange and the application of confidentiality and personal data protection rules. ANNEX 18 AUTHORISED ECONOMIC OPERATORS Article 1 Criteria for and treatment of Authorised Economic Operators 1. The specified criteria for qualification as an Authorised Economic Operator (\"AEO\") referred to in Article 110 of this Agreement, shall be established by the Parties' laws, regulations or procedures. The specified criteria, which shall be published, shall include: (a) the absence of any serious infringement or repeated infringements of customs legislation and taxation rules, including no record of serious criminal offences relating to the economic activity of the applicant; (b) the demonstration by the applicant of a high level of control of his or her operations and of the flow of goods, by means of a system of managing commercial and, where appropriate, transport records, which allows appropriate customs controls; (c) financial solvency which shall be deemed to be proven where the applicant has good financial standing, which enables him or her to fulfil his or her commitments, with due regard to the characteristics of the type of business activity concerned; and (d) appropriate security and safety standards which shall be considered as fulfilled where the applicant demonstrates that he or she maintains appropriate measures to ensure the security and safety of the international supply chain including in the areas of physical integrity and access controls, logistical processes and handling of specific types of goods, personnel and identification of his or her business partners. 2. The specified criteria for qualification as an AEO shall not be designed or applied so as to afford or create arbitrary or unjustifiable discrimination between operators where the same conditions prevail. Those criteria shall allow small and medium-sized enterprises to qualify as AEOs. 3. The trade partnership programme referred to in Article 110 of this Agreement shall include the following treatment: (a) taking the AEO status granted by the other Party favourably into account in its risk assessment to reduce inspections or controls and in other security and safety-related measures; (b) giving priority to the inspection of consignments covered by exit or entry summary declarations lodged by an AEO, if the customs authority decides to proceed with an inspection; (c) taking the AEO status granted by the other Party into account with a view to treating the AEO as a secure and safe partner when assessing requirements concerning business partners for applicants under its own Programme; and (d) endeavouring to establish a joint business continuity mechanism to respond to disruptions in trade flows due to increases in security alerts levels, border closures and/or natural disasters, hazardous emergencies or other major incidents where priority cargos related to AEOs could be facilitated and expedited to the extent possible by the customs authorities of the Parties. Article 2 Mutual recognition and responsibility for implementation 1. AEO Status under the trade partnership programmes of the Union and the United Kingdom are recognised to be compatible, and holders of the AEO status granted under each programme shall be treated in a manner consistent with Article 4. 2. The trade partnership programmes concerned are: a) The European Union Authorised Economic operator (security and safety) (point (b) of Article 38(2) of Regulation (EU) No 952/2013); b) The United Kingdom Authorised Economic Operator programme (security and safety) (point (b) of Article 38(2) of Regulation (EU) No 952/2013, as retained in United Kingdom domestic law). 3. The customs authorities, as defined in point (a) of Article 512 of this Agreement (\"customs authorities\"), are responsible for the implementation of the provisions in this Annex. Article 3 Compatibility 1. The Parties shall cooperate to maintain compatibility of the standards applied to each of their trade partnership programmes with respect to the following matters: (a) the application process for granting the AEO status to operators; (b) the assessment of AEO status applications; (c) the granting of the AEO status; and (d) the managing, monitoring, suspension and re-assessment, and revocation of the AEO status. The Parties shall ensure that their customs authorities monitor AEOs\u2032 compliance with the relevant conditions and criteria. 2. The Parties shall complete a joint work programme setting out a minimum number of joint validations of holders of the AEO status granted under each trade partnership programme that must be completed by the end of 2021, at the latest. 3. The Parties shall ensure that their trade partnership programmes operate within the relevant standards of the SAFE Framework. Article 4 Treatment of status holders 1. Each Party shall provide comparable treatment to that given to AEOs under the other Party's trade partnership programme. This treatment shall include in particular the treatment set out in Article 1(3). 2. Each Party may suspend the treatment referred to in Article 1(3) to an AEO under the other Party's trade partnership programme under this Agreement if that AEO ceases to comply with the legal requirements. Such suspension shall be promptly communicated to the other customs authority together with any additional information regarding the basis for suspension, as appropriate. 3. Each Party shall promptly inform the other Party in cases where it identifies any irregularity committed by an AEO authorised by the other customs authority to allow it to take an informed decision on the possible revocation or suspension of the membership of the operator concerned. Article 5 Exchange of information and communication 1. The Parties shall endeavour to communicate effectively with each other in the implementation of this Agreement. They shall exchange information and foster communication regarding their trade partnership programmes, in particular by: (a) providing updates on the operation and development of their trade partnership programmes in a timely manner; (b) engaging in mutually beneficial exchanges of information regarding supply chain security; (c) designating the contact points for their respective trade partnership programmes and providing the contact details for those contact points to the other Party; and (d) facilitating effective inter-agency communication between the European Commission's Directorate-General for Taxation and Customs Union and Her Majesty's Revenue and Customs to enhance risk management practices under their respective trade partnership programmes with respect to supply chain security on the part of AEOs. 2. Information and related data shall be exchanged in a systematic manner by electronic means. 3. The data to be exchanged regarding AEOs shall include: (a) name; (b) address; (c) status of membership; (d) validation or authorisation date; (e) suspensions and revocations; (f) the unique authorisation or identification number (in a form mutually determined by the customs authorities); and (g) other details that may be mutually determined between the customs authorities, subject, where applicable, to any necessary safeguards. The exchange of data shall commence with the entry into force of this Agreement. 4. The Parties shall use their best endeavours to establish, within six months of entry into force of this Agreement, an arrangement for fully automated exchange of the data referred to in paragraph 3, and in any event shall implement such an arrangement no later than one year after the entry into force of this Agreement. Article 6 Treatment of data Any exchange of information between the Parties under this Annex shall be mutatis mutandis subject to the confidentiality and protection of information set out in Article 12 of the Protocol on mutual administrative assistance in customs matters. Article 7 Consultation and review The Trade Specialised Committee on Customs Cooperation and Rules of Origin shall review the implementation of the provisions of this Annex regularly. That review shall include: (a) joint validations of AEOs granted status by each Party to identify strengths and weaknesses in implementing this Annex; (b) exchanges of views on data to be shared and treatment of operators. Article 8 Suspension and discontinuation 1. A Party may pursue the procedure set out in paragraph 2 in the event that either of the following circumstances arise: a) Before or within three months of entry into force of this Agreement the other Party has made material changes to the legal provisions referred to in Article 2(2) that were assessed in order to establish that the trade partnership programmes are compatible, such that the compatibility required for recognition under Article 2(1) has ceased to exist. b) The provisions under Article 5(2) are not operational. 2. In the event that either of the circumstances set out in point (a) or (b) of paragraph 1 arise, a Party may suspend the recognition provided for in Article 2(1) 60 days after notifying the other Party of their intention. 3. Where a party gives notice of its intention to suspend the recognition provided for in Article 2(1) in accordance with paragraph 2 of this Article, the other Party may request consultations in the Trade Specialised Committee on Customs Cooperation and Rules of Origin. These consultations shall be held within 60 days of the request. 4. A Party may pursue the procedure set out in paragraph 5 in the event that either of the following circumstances arise: a) The other Party changes its AEO programme or its implementation of this programme such that the compatibility required for recognition under Article 2(1) has ceased to exist; b) The joint validations provided for in Article 3(2) do not confirm the compatibility of the Parties' respective AEO programmes. 5. In the event that either of the circumstances set out in point (a) or (b) of paragraph 4 arise, a Party may request consultations with the other Party in the framework of the Trade Specialised Committee on Customs Cooperation and Rules of Origin. These consultations shall be held within 60 days from the request. If 90 days after the request a Party still considers that the compatibility required for recognition under Article 2(1) has ceased to exist, it may notify the other Party of its intention to suspend recognition of its programme. Suspension shall take effect 30 days after notification. ANNEX 19 EXISTING MEASURES Headnotes 1. The Schedules of the United Kingdom and the Union set out, under Articles 133, 139 and 195 of this Agreement, the reservations taken by the United Kingdom and the Union with respect to existing measures that do not conform with obligations imposed by: (a) Article 128 or 135 of this Agreement; (b) Article 136 of this Agreement; (c) Article 129 or 137 of this Agreement; (d) Article 130 or 138 of this Agreement; (e) Article 131 of this Agreement; (f) Article 132 of this Agreement; or (g) Article 194 of this Agreement. 2. The reservations of a Party are without prejudice to the rights and obligations of the Parties under GATS. 3. Each reservation sets out the following elements: (a) \"sector\" refers to the general sector in which the reservation is taken; (b) \"sub-sector\" refers to the specific sector in which the reservation is taken; (c) \"industry classification\" refers, where applicable, to the activity covered by the reservation according to the CPC, ISIC Rev. 3.1, or as expressly otherwise described in that reservation; (d) \"type of reservation\" specifies the obligation referred to in paragraph 1 for which a reservation is taken; (e) \"level of government\" indicates the level of government maintaining the measure for which a reservation is taken; (f) \"measures\" identifies the laws or other measures as qualified, where indicated, by the \"description\" element for which the reservation is taken. A \"measure\" cited in the \"measures\" element: (i) means the measure as amended, continued or renewed as of the date of entry into force of this Agreement; (ii) includes any subordinate measure adopted or maintained under the authority of and consistent with the measure; and (iii) in respect of the Schedule of the Union, includes any laws or other measures which implement a directive at Member State level; and (g) \"description\" sets out the non-conforming aspects of the existing measure for which the reservation is taken. 4. For greater certainty, if a Party adopts a new measure at a level of government different to that at which the reservation was originally taken, and this new measure effectively replaces \u2013 within the territory to which it applies \u2013 the non-conforming aspect of the original measure cited in the \"measures\" element, the new measure shall be deemed to constitute \"modification\" to the original measure within the meaning of point (c) of Article 133(1), point (c) of Article 139(1), point (c) of Article 144 and point (c) of Article 195(1) of this Agreement. 5. In the interpretation of a reservation, all elements of the reservation shall be considered. A reservation shall be interpreted in the light of the relevant obligations of the Chapters or Sections against which the reservation is taken. The \"measures\" element shall prevail over all other elements. 6. For the purposes of the Schedules of the United Kingdom and the Union: (a) \"ISIC Rev. 3.1\" means the International Standard Industrial Classification of All Economic Activities as set out in Statistical Office of the United Nations, Statistical Papers, Series M, No.4, ISIC Rev. 3.1, 2002; (b) \"CPC\" means the Provisional Central Product Classification (Statistical Papers, Series M No. 77, Department of International Economic and Social Affairs, Statistical Office of the United Nations, New York, 1991). 7. For the purposes of the Schedules of the United Kingdom and the Union, a reservation for a requirement to have a local presence in the territory of the Union or the United Kingdom is taken against Article 136 of this Agreement, and not against Article 135 or 137 of this Agreement. Furthermore, such a requirement is not taken as a reservation against Article 129 of this Agreement. 8. A reservation taken at the level of the Union applies to a measure of the Union, to a measure of a Member State at the central level or to a measure of a government within a Member State, unless the reservation excludes a Member State. A reservation taken by a Member State applies to a measure of a government at the central, regional or local level within that Member State. For the purposes of the reservations of Belgium, the central level of government covers the federal government and the governments of the regions and the communities as each of them holds equipollent legislative powers. For the purposes of the reservations of the Union and its Member States, a regional level of government in Finland means the \u00c5land Islands. A reservation taken at the level of the United Kingdom applies to a measure of the central government, a regional government or a local government. 9. The list of reservations below does not include measures relating to qualification requirements and procedures, technical standards and licensing requirements and procedures where they do not constitute a limitation within the meaning of Article 128, 129, 135, 136, 137 or 194 of this Agreement. These measures may include, in particular, the need to obtain a licence, to satisfy universal service obligations, to have recognised qualifications in regulated sectors, to pass specific examinations, including language examinations, to fulfil a membership requirement of a particular profession, such as membership in a professional organisation, to have a local agent for service, or to maintain a local address, or any other non-discriminatory requirements that certain activities may not be carried out in protected zones or areas. While not listed, such measures continue to apply. 10. For greater certainty, for the Union, the obligation to grant national treatment does not entail the requirement to extend to natural or legal persons of the United Kingdom the treatment granted in a Member State, pursuant to the Treaty on the Functioning of the European Union, or any measure adopted pursuant to that Treaty, including their implementation in the Member States, to: (i) natural persons or residents of another Member State; or (ii) legal persons constituted or organised under the law of another Member State or of the Union and having their registered office, central administration or principal place of business in the Union. 11. Treatment granted to legal persons established by investors of a Party in accordance with the law of the other Party (including, in the case of the Union, the law of a Member State) and having their registered office, central administration or principal place of business within that other Party, is without prejudice to any condition or obligation, consistent with Chapter 2 of Title II of Heading One of Part Two of this Agreement, which may have been imposed on such legal person when it was established in that other Party, and which shall continue to apply. 12. The Schedules apply only to the territories of the United Kingdom and the Union in accordance with Article 520(2) and Article 774 of this Agreement and are only relevant in the context of trade relations between the Union and its Member States with the United Kingdom. They do not affect the rights and obligations of the Member States under Union law. 13. For greater certainty, non-discriminatory measures do not constitute a market access limitation within the meaning of Article 128, 135 or 194 of this Agreement for any measure: (a) requiring the separation of the ownership of infrastructure from the ownership of the goods or services provided through that infrastructure to ensure fair competition, for example in the fields of energy, transportation and telecommunications; (b) restricting the concentration of ownership to ensure fair competition; (c) seeking to ensure the conservation and protection of natural resources and the environment, including a limitation on the availability, number and scope of concessions granted, and the imposition of a moratorium or ban; (d) limiting the number of authorisations granted because of technical or physical constraints, for example telecommunications spectra and frequencies; or (e) requiring that a certain percentage of the shareholders, owners, partners, or directors of an enterprise be qualified or practice a certain profession such as lawyers or accountants. 14. With respect to financial services: Unlike foreign subsidiaries, branches established directly in a Member State by a non-European Union financial institution are not, with certain limited exceptions, subject to prudential regulations harmonised at Union level which enable such subsidiaries to benefit from enhanced facilities to set up new establishments and to provide cross-border services throughout the Union. Therefore, such branches receive an authorisation to operate in the territory of a Member State under conditions equivalent to those applied to domestic financial institutions of that Member State, and may be required to satisfy a number of specific prudential requirements such as, in the case of banking and securities, separate capitalisation and other solvency requirements and reporting and publication of accounts requirements or, in the case of insurance, specific guarantee and deposit requirements, a separate capitalisation, and the localisation in the Member State concerned of the assets representing the technical reserves and at least one third of the solvency margin. The following abbreviations are used in the list of reservations below: UK United Kingdom EU European Union, including all its Member States AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czechia DE Germany DK Denmark EE Estonia EL Greece ES Spain FI Finland FR France HR Croatia HU Hungary IE Ireland IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta NL The Netherlands PL Poland PT Portugal RO Romania SE Sweden SI Slovenia SK Slovak Republic Schedule of the Union Reservation No. 1 - All sectors Reservation No. 2 - Professional services (except health-related professions) Reservation No. 3 - Professional services (health related and retail of pharmaceuticals) Reservation No. 4 - Research and development services Reservation No. 5 - Real estate services Reservation No. 6 - Business services Reservation No. 7 - Communication services Reservation No. 8 - Construction Services Reservation No. 9 - Distribution services Reservation No. 10 - Education services Reservation No. 11 - Environmental services Reservation No. 12 - Financial Services Reservation No. 13 - Health services and social services Reservation No. 14 - Tourism and travel related services Reservation No. 15 - Recreational, cultural and sporting services Reservation No. 16 - Transport services and services auxiliary to transport services Reservation No. 17 - Energy related activities Reservation No. 18 - Agriculture, fishing and manufacturing Reservation No. 1 - All sectors Sector: All sectors Type of reservation: Market access National treatment Most-favoured-nation treatment Performance requirements Senior management and boards of directors Obligations for legal services Chapter/Section: Investment liberalisation; Cross-border trade in services and Regulatory framework for legal services Level of government: EU/Member State (unless otherwise specified) Description: (a) Type of establishment With respect to Investment liberalisation \u2013 National treatment and Regulatory framework for legal services \u2013 Obligations: The EU: Treatment granted pursuant to the Treaty on the Functioning of the European Union to legal persons formed in accordance with the law of the Union or of a Member State and having their registered office, central administration or principal place of business within the Union, including those established in the Union by investors of the United Kingdom, is not accorded to legal persons established outside the Union, nor to branches or representative offices of such legal persons, including to branches or representative offices of legal persons of the United Kingdom. Treatment less favourable may be accorded to legal persons formed in accordance with the law of the Union or of a Member State which have only their registered office in the Union, unless it can be shown that they possess an effective and continuous link with the economy of one of the Member States. Measures: EU: Treaty on the Functioning of the European Union. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors: This reservation applies only to health, social or education services: The EU (applies also to the regional level of government): Any Member State, when selling or disposing of its equity interests in, or the assets of, an existing state enterprise or an existing governmental entity providing health, social or education services (CPC 93, 92), may prohibit or impose limitations on the ownership of such interests or assets, and/or restrict the ability of owners of such interests and assets to control any resulting enterprise, with respect to investors of the United Kingdom or their enterprises. With respect to such a sale or other disposition, any Member State may adopt or maintain any measure relating to the nationality of senior management or members of the boards of directors, as well as any measure limiting the number of suppliers. For the purposes of this reservation: (i) any measure maintained or adopted after the date of entry into force of this Agreement that, at the time of the sale or other disposition, prohibits or imposes limitations on the ownership of equity interests or assets or imposes nationality requirements or imposes limitations on the numbers of suppliers as described in this reservation shall be deemed to be an existing measure; and (ii) \"state enterprise\" means an enterprise owned or controlled through ownership interests by any Member State and includes an enterprise established after the date of entry into force of this Agreement solely for the purposes of selling or disposing of equity interests in, or the assets of, an existing state enterprise or governmental entity. Measures: EU: As set out in the description element as indicated above. With respect to Investment liberalisation \u2013 National Treatment and Regulatory framework for legal services \u2013 Obligations In AT: For the operation of a branch, non-European Economic Area (non-EEA) corporations must appoint at least one person responsible for its representation who is resident in Austria. Executives (managing directors, natural persons) responsible for the observance of the Austrian Trade Act (Gewerbeordnung) must be domiciled in Austria. In BG: Foreign legal persons, unless established under the legislation of a Member State of the European Economic Area (EEA), may conduct business and pursue activities if established in the Republic of Bulgaria in the form of a company registered in the Commercial Register. Establishment of branches is subject to authorisation. Representative offices of foreign enterprises are to be registered with Bulgarian Chamber of Commerce and Industry and may not engage in economic activity but are only entitled to advertise their owner and act as representatives or agents. In EE: If the residence of at least half of the members of the management board of a private limited company, a public limited company or a branch is not in Estonia, in another Member State of the EEA or in the Swiss Confederation, the private limited company, the public limited company or the foreign company shall appoint a point of contact whose Estonian address can be used for the delivery of the procedural documents of the undertaking and the declarations of intent addressed to the undertaking (i.e. the branch of a foreign company). With respect to Investment liberalisation \u2013 National treatment; Cross-border trade in services \u2013 Market access and Regulatory framework for legal services \u2013 Obligations: In FI: At least one of the partners in a general partnership or of general partners in a limited partnership needs to have residency in the EEA or, if the partner is a legal person, be domiciled (no branches allowed) in the EEA. Exemptions may be granted by the registration authority. To carry on trade as a private entrepreneur, residency in the EEA is required. If a foreign organisation from a country outside the EEA intends to carry on a business or trade by establishing a branch in Finland, a trade permit is required. Residency in the EEA is required for at least one of the ordinary and one of the deputy members of the board of directors and for the managing director. Company exemptions may be granted by the registration authority. In SE: A foreign company, which has not established a legal entity in Sweden or is conducting its business through a commercial agent, shall conduct its commercial operations through a branch, registered in Sweden, with independent management and separate accounts. The managing director and the vice-managing director, if appointed, of the branch, must reside in the EEA. A natural person not resident in the EEA, who conducts commercial operations in Sweden, shall appoint and register a resident representative responsible for the operations in Sweden. Separate accounts shall be kept for the operations in Sweden. The competent authority may in individual cases grant exemptions from the branch and residency requirements. Building projects with duration of less than a year, conducted by a company located or a natural person residing outside the EEA, are exempted from the requirements of establishing a branch or appointing a resident representative. For limited liability companies and co-operative economic associations, at least 50 per cent of the members of the board of directors, at least 50 per cent of the deputy board members, the managing director, the vice-managing director, and at least one of the persons authorised to sign for the company, if any, must reside within the EEA. The competent authority may grant exemptions from this requirement. If none of the company's or society's representatives reside in Sweden, the board must appoint and register a person resident in Sweden, who has been authorised to receive servings on behalf of the company or society. Corresponding conditions prevail for establishment of all other types of legal entities. In SK: A foreign natural person whose name is to be registered in the appropriate register (Commercial register, Entrepreneurial or other professional register) as a person authorised to act on behalf of an entrepreneur is required to submit a residence permit for Slovakia. Measures: AT: Aktiengesetz, BGBL. Nr. 98/1965, \u00a7 254 (2); GmbH-Gesetz, RGBL. Nr. 58/1906, \u00a7 107 (2); and Gewerbeordnung, BGBL. Nr. 194/1994, \u00a7 39 (2a). BG: Commercial Law, Article 17a; and Law for Encouragement of Investments, Article 24. EE: \u00c4riseadustik (Commercial Code) \u00a7 631 (1, 2 and 4). FI: Laki elinkeinon harjoittamisen oikeudesta (Act on the Right to Carry on a Trade) (122/1919), s. 1; Osuuskuntalaki (Co-Operatives Act) 1488/2001; Osakeyhti\u00f6laki (Limited Liabilities Company Act) (624/2006); and Laki luottolaitostoiminnasta (Act on Credit Institutions) (121/2007). SE: Lag om utl\u00e4ndska filialer m.m (Foreign Branch Offices Act) (1992:160); Aktiebolagslagen (Companies Act) (2005:551); The Co-operative Economic Associations Act (2018:672); and Act on European Economic Interest Groupings (1994:1927). SK: Act 513/1991 on Commercial Code (Article 21); Act 455/1991 on Trade Licensing; and Act no 404/2011 on Residence of Aliens (Articles 22 and 32). With respect to Investment liberalisation \u2013 Market Access, National Treatment, Performance requirements and Regulatory framework for legal services \u2013 Obligations: In BG: Established enterprises may employ third country nationals only for positions for which there is no requirement for Bulgarian nationality. The total number of third country nationals employed by an established enterprise over a period of the preceding 12 months must not exceed 20 percent (35 percent for small and medium-sized enterprises) of the average number of Bulgarian nationals, nationals of other Member States, of states parties to the Agreement on the EEA or of the Swiss Confederation hired on an employment contract. In addition, the employer must demonstrate that there is no suitable Bulgarian, EU, EEA or Swiss worker for the respective position by conducting a labour market test before employing a third country national. For highly qualified, seasonal and posted workers, as well as for intra-corporate transferees, researchers and students there is no limitation on the number of third country nationals working for a single enterprise. For the employment of third country nationals in these categories, no labour market test is required. Measures: BG: Labour Migration and Labour Mobility Act. With respect to Investment liberalisation \u2013 Market access, National treatment: In PL: The scope of operations of a representative office may only encompass advertising and promotion of the foreign parent company represented by the office. For all sectors except legal services, establishment by non-European Union investors and their enterprises may only be in the form of a limited partnership, limited joint-stock partnership, limited liability company, and joint-stock company, while domestic investors and enterprises have access also to the forms of non-commercial partnership companies (general partnership and unlimited liability partnership). Measures: PL: Act of 6 March 2018 on rules regarding economic activity of foreign entrepreneurs and other foreign persons in the territory of the Republic of Poland. (b) Acquisition of real estate With respect to Investment liberalisation \u2013 National treatment: In AT (applies to the regional level of government): The acquisition, purchase and rental or leasing of real estate by non-European Union natural persons and enterprises requires authorisation by the competent regional authorities (L\u00e4nder). Authorisation will only be granted if the acquisition is considered to be in the public (in particular economic, social and cultural) interest. In CY: Cypriots or persons of Cypriot origin, as well as nationals of a Member State, are allowed to acquire any property in Cyprus without restrictions. A foreigner shall not acquire, otherwise than mortis causa, any immovable property without obtaining a permit from the Council of Ministers. For foreigners, where the acquisition of immovable property exceeds the extent necessary for the erection of a premises for a house or professional roof, or otherwise exceeds the extent of two donums (2,676 square meter), any permit granted by the Council of Ministers shall be subject to such terms, limitations, conditions and criteria which are set by Regulations made by the Council of Ministers and approved by the House of Representatives. A foreigner is any person who is not a citizen of the Republic of Cyprus, including a foreign controlled company. The term does not include foreigners of Cypriot origin or non-Cypriot spouses of citizens of the Republic of Cyprus. In CZ: Specific rules apply to agricultural land under state ownership. State agricultural land can be acquired only by Czech nationals, nationals of another Member State, or states parties to the Agreement on the EEA or the Swiss Confederation. Legal persons can acquire state agriculture land from the state only if they are agricultural entrepreneurs in the Czech Republic or persons with similar status in other Member State of the European Union, or states parties to the Agreement on the EEA or the Swiss Confederation. In DK: Natural persons who are not resident in Denmark, and who have not previously been resident in Denmark for a total period of five years, must in accordance with the Danish Acquisition Act obtain permission from the Ministry of Justice to acquire title to real property in Denmark. This also applies for legal persons that are not registered in Denmark. For natural persons, acquisition of real property will be permitted if the applicant is going to use the real property as his or her primary residence. For legal persons that are not registered in Denmark, acquisition of real property will in general be permitted, if the acquisition is a prerequisite for the business activities of the purchaser. Permission is also required if the applicant is going to use the real property as a secondary dwelling. Such permission will only be granted if the applicant through an overall and concrete assessment is regarded to have particular strong ties to Denmark. Permission under the Acquisition Act is only granted for the acquisition of a specific real property. The acquisition of agricultural land by natural or legal persons is in addition governed by the Danish Agricultural Holdings Act, which imposes restrictions on all persons, Danish or foreign, when acquiring agricultural property. Accordingly, any natural or legal person, who wishes to acquire agricultural real property, must fulfil the requirements in this Act. This generally means a limited residence requirement on the agricultural holding applies. The residence requirement is not personal. Legal entities must be of the types listed in \u00a720 and \u00a721 of the act and must be registered in the Union (or EEA). In EE: A legal person from an OECD Member State has the right to acquire an immovable which contains: (i) less than ten hectares of agricultural land, forest land or agricultural and forest land in total without restrictions. (ii) ten hectares or more of agricultural land if the legal person has been engaged, for three years immediately preceding the year of making the transaction of acquisition of the immovable, in production of agricultural products listed in Annex I to the Treaty on the Functioning of the European Union, except fishery products and cotton (hereinafter agricultural product). (iii) ten hectares or more of forest land if the legal person has been engaged, for three years immediately preceding the year of making the transaction of acquisition of the immovable, in forest management within the meaning of the Forest Act (hereinafter forest management) or production of agricultural products. (iv) less than ten hectares of agricultural land and less than ten hectares of forest land, but ten hectares or more of agricultural and forest land in total, if the legal person has been engaged, for three years immediately preceding the year of making the transaction of acquisition of the immovable, in production of agricultural products or forest management. If a legal person does not meet the requirements provided for in (ii)\u2013(iv), the legal person may acquire an immovable which contains ten hectares or more of agricultural land, forest land or agricultural and forest land in total only with the authorisation of the council of the local government of the location of the immovable to be acquired. Restrictions on acquiring immovable property apply in certain geographical areas for non-EEA nationals. In EL: Real estate acquisition or tenancy in the border regions is prohibited to natural or legal persons whose nationality or base is outside the Member States and the European Free Trade Association. The ban may be lifted with a discretionary decision taken by a committee of the appropriate Decentralized Administration (or the Minister of National Defense in case the properties to be exploited belong to the Fund for the Exploitation of Private Public Property). In HR: Foreign companies are only allowed to acquire real estate for the supply of services if they are established and incorporated in Croatia as legal persons. Acquisition of real estate necessary for the supply of services by branches requires the approval of the Ministry of Justice. Agricultural land cannot be acquired by foreigners. In MT: Non-nationals of a Member State may not acquire immovable property for commercial purposes. Companies with 25 per cent (or more) of non-European Union shareholding must obtain an authorisation from the competent authority (Minister responsible for Finance) to buy immovable property for commercial or business purposes. The competent authority will determine whether the proposed acquisition represents a net benefit to the Maltese economy. In PL: The acquisition of real estate, direct and indirect, by foreigners requires a permit. A permit is issued through an administrative decision by a minister competent in internal affairs, with the consent of the Minister of National Defence, and in the case of agricultural real estate, also with the consent of the Minister of Agriculture and Rural Development. Measures: AT: Burgenl\u00e4ndisches Grundverkehrsgesetz, LGBL. Nr. 25/2007; K\u00e4rntner Grundverkehrsgesetz, LGBL. Nr. 9/2004; N\u00d6- Grundverkehrsgesetz, LGBL. 6800; O\u00d6- Grundverkehrsgesetz, LGBL. Nr. 88/1994; Salzburger Grundverkehrsgesetz, LGBL. Nr. 9/2002; Steierm\u00e4rkisches Grundverkehrsgesetz, LGBL. Nr. 134/1993; Tiroler Grundverkehrsgesetz, LGBL. Nr. 61/1996; Voralberger Grundverkehrsgesetz, LGBL. Nr. 42/2004; and Wiener Ausl\u00e4ndergrundverkehrsgesetz, LGBL. Nr. 11/1998. CY: Immovable Property Acquisition (Aliens) Law (Chapter 109), as amended. CZ: Act No. 503/2012, Coll. on State Land Office as amended. DK: Danish Act on Acquisition of Real Property (Consolidation Act No. 265 of 21 March 2014 on Acquisition of Real Property); Acquisition Executive Order (Executive Order No. 764 of 18 September 1995); and The Agricultural Holdings Act (Consolidation Act No. 27 of 4 January 2017). EE: Kinnisasja omandamise kitsendamise seadus (Restrictions on Acquisition of Immovables Act) Chapter 2 \u00a7 4, Chapter 3\u00a7 10, 2017. EL: Law 1892/1990, as it stands today, in combination, as far as the application is concerned, with the ministerial decision F.110/3/330340/S.120/7-4-14 of the Minister of National Defense and the Minister of Citizen Protection. HR: Ownership and other Proprietary Rights Act (OG 91/96, 68/98, 137/99, 22/00, 73/00, 129/00, 114/01, 79/06, 141/06, 146/08, 38/09, 143/12, 152/14), Articles 354 to 358.b; Agricultural Land Act (OG 20/18, 115/18, 98/19) Article 2; General Administrative Procedure Act. MT: Immovable Property (Acquisition by Non-Residents) Act (Cap. 246); and Protocol No 6 of the EU Accession Treaty on the acquisition of secondary residences in Malta. PL: Law of 24th March 1920 on the Acquisition of Real Estate by Foreigners (Journal of Laws of 2016, item 1061 as amended). With respect to Investment liberalisation \u2013 Market access, National treatment: In HU: The purchase of real estate by non-residents is subject to obtaining authorisation from the appropriate administrative authority responsible for the geographical location of the property. Measures: HU: Government Decree No. 251/2014 (X. 2.) on the Acquisition by Foreign Nationals of Real Estate other than Land Used for Agricultural or Forestry Purposes; and Act LXXVIII of 1993 (Paragraph 1/A). With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment: In LV: Acquisition of urban land by nationals of the United Kingdom is permitted through legal persons registered in Latvia or other Member States: (i) if more than 50 per cent of their equity capital is owned by nationals of Member States, the Latvian Government or a municipality, separately or in total; (ii) if more than 50 per cent of their equity capital is owned by natural persons and companies of third country with whom Latvia has concluded bilateral agreements on promotion and reciprocal protection of investments and which have been approved by the Latvian Parliament before 31 December 1996; (iii) if more than 50 per cent of their equity capital is possessed by natural persons and companies of third country with whom Latvia has concluded bilateral agreements on promotion and reciprocal protection of investments after 31 December 1996, if in those agreements the rights of Latvian natural persons and companies on acquisition of land in the respective third country have been determined; (iv) if more than 50 per cent of their equity capital is possessed jointly by persons referred to in points (i) to (iii); or (v) which are public joint stock companies, if their shares thereof are quoted in the stock exchange. Where the United Kingdom allows Latvian nationals and enterprises to purchase urban real estate in their territories, Latvia will allow nationals and enterprises of the United Kingdom to purchase urban real estate in Latvia under the same conditions as Latvian nationals. Measures: LV: Law on land reform in the cities of the Republic of Latvia, Section 20 and 21. With respect to Investment liberalisation - National treatment, Most-favoured-nation treatment: In DE: Certain conditions of reciprocity may apply for the acquisition of real estate. In ES: Foreign investment in activities directly relating to real estate investments for diplomatic missions by states that are not Member States requires an administrative authorisation from the Spanish Council of Ministers, unless there is a reciprocal liberalisation agreement in place. In RO: Foreign nationals, stateless persons and legal persons (other than nationals and legal persons of a Member State of the EEA) may acquire property rights over lands, under the conditions regulated by international treaties, based on reciprocity. Foreign nationals, stateless persons and legal persons may not acquire the property right over lands under more favourable conditions than those applicable to natural or legal persons of the European Union. Measures: DE: Einf\u00fchrungsgesetz zum B\u00fcrgerlichen Gesetzbuche (EGBGB; Introductory Law to the Civil Code). ES: Royal Decree 664/1999 of 23 April 1999 relating to foreign investment. RO: Law 17/2014 on some measures regulating the selling-buying agricultural land situated outside town and amending; and Law No 268/2001 on the privatization of companies that own land in public ownership and private management of the state for agricultural and establishing the State Domains Agency, with subsequent amendments. Reservation No. 2 - Professional services (except health-related professions) Sector \u2013 sub-sector: Professional services \u2013 legal services; patent agent, industrial property agent, intellectual property attorney; accounting and bookkeeping services; auditing services, taxation advisory services; architecture and urban planning services, engineering services and integrated engineering services Industry classification: CPC 861, 862, 863, 8671, 8672, 8673, 8674, part of 879 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Obligations for legal Services Chapter/Section: Investment liberalisation, Cross-border trade in services and Regulatory framework for legal services Level of government: EU/Member State (unless otherwise specified) Description: (a) Legal services (part of CPC 861) (1) With respect to Investment liberalisation \u2013 Market access \u2013 and Regulatory framework for legal services \u2013 Obligations In EU: Specific non-discriminatory legal form requirements apply in each Member State. (i) Designated legal services supplied under the home professional title (part of CPC 861 \u2013 legal advisory, arbitration, conciliation and mediation services with regard to home-jurisdiction and international law governed by Section 7 of Chapter 5 of Title II of Heading One of Part Two of this Agreement). For greater certainty, consistent with the Headnotes, in particular paragraph 9, requirements to register with a Bar may include a requirement to have completed some training under the supervision of a licensed lawyer, or to have an office or a postal address within the jurisdiction of a specific Bar in order to be eligible to apply for membership in that Bar. Some Member States may impose the requirement of having the right to practise host-jurisdiction law on those natural persons holding certain positions within a law firm/company/enterprise or for shareholders. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 National treatment, Market access and Regulatory framework for legal services \u2013 Obligations: In AT: EEA or Swiss nationality as well as residency (commercial presence) is required for the practice of legal services in respect of host jurisdiction (Union and Member State) law, including representation before courts. Only lawyers of EEA or Swiss nationality are allowed to provide legal services through commercial presence. The practice of legal services in respect of public international law and home-jurisdiction law is only allowed on a cross-border basis. Equity participation and shares in the operating result of any law firm by foreign lawyers (who must be fully qualified in their home-jurisdiction) is allowed up to 25 per cent; the rest must be held by fully qualified EEA or Swiss lawyers and only the latter may exercise decisive influence in the decision making of the law firm. In BE: (with respect also to Most-favoured-nation treatment) Foreign lawyers may practise as legal consultants. Lawyers who are members of foreign (non-EU) Bars and want to establish in Belgium but do not meet the conditions for registration on the Tableau of fully qualified lawyers, on the EU-list or on the List of Trainee Lawyers, may request registration on the so-called \"B-List\". Only at the Brussels Bar there exists such a \"B-List\". A lawyer on the B-list is allowed to supply designated legal services. In BG: (with respect also to Most-favoured-nation treatment): Permanent residency is required for legal mediation services. A mediator may be only a person who has been entered in the Uniform Register of Mediators with the Minister of Justice. In Bulgaria, full national treatment on the establishment and operation of companies, as well as on the supply of services, may be extended only to companies established in, and citizens of, countries with whom bilateral agreements on mutual legal assistance have been or will be concluded. In CY: EEA or Swiss nationality as well as residency (commercial presence) is required. Only advocates enrolled in the Bar may be partners or shareholders or members of the board of directors in a law company in Cyprus. In CZ: For foreign lawyers residence (commercial presence) is required. In DE: For foreign lawyers (with other than EEA and Swiss qualification) there may be restrictions for holding shares of a lawyers company which provides legal services in host-jurisdiction law. In DK: Without prejudice to the EU reservation above, shares of a law firm can only be owned by advocates who actively practise law in the firm, its parent company or its subsidiary company, other employees in the firm, or another law firm registered in Denmark. Other employees in the firm may collectively only own less than 10 per cent of the shares and of the voting rights, and in order to be shareholders they must pass an exam on the rules of particular importance for the practice of law. Only advocates who actively practise law in the firm, its parent company or its subsidiary company, other shareholders, and representatives of employees, may be members of the board. The majority of the members of the board must be advocates who actively practise law in the firm, its parent company or its subsidiary company. Only advocates who actively practise law in the firm, its parent company or its subsidiary company, and other shareholders having passed the exam mentioned above, may be a director of the law firm. In ES: Professional address is required in order to provide designated legal services. In FR, Residency or establishment in the EEA is required to practise on a permanent basis. Without prejudice to the EU reservation above: For all lawyers, company must take one of the following legal forms authorised under French law on a non-discriminatory basis: SCP (soci\u00e9t\u00e9 civile professionnelle), SEL (soci\u00e9t\u00e9 d'exercice lib\u00e9ral), SEP (soci\u00e9t\u00e9 en participation), SARL (soci\u00e9t\u00e9 \u00e0 responsabilit\u00e9 limit\u00e9e), SAS (soci\u00e9t\u00e9 par actions simplifi\u00e9e), SA (soci\u00e9t\u00e9 anonyme), SPE (soci\u00e9t\u00e9 pluriprofessionnelle d'exercice) and \"association\", under certain conditions. Shareholders, directors and partners may be subject to specific restrictions related to their professional activity. In HR: Only a lawyer who has the Croatian title of lawyer can establish a law firm (UK firms can establish branches, which may not employ Croatian lawyers). In HU: A cooperation contract concluded with a Hungarian attorney (\u00fcgyv\u00e9d) or law firm (\u00fcgyv\u00e9di iroda) is required. A foreign legal adviser cannot be a member of a Hungarian law firm. A foreign lawyer is not authorized for the preparation of documents to be submitted to, or act as the client's legal representative before an arbitrator, conciliator or mediator in any dispute. In PT (with respect also to Most-favoured-nation treatment): Foreigners holding a diploma awarded by any Faculty of Law in Portugal, may register with the Portuguese Bar (Ordem dos Advogados), under the same terms as Portuguese nationals, if their respective country grants Portuguese nationals reciprocal treatment. Other foreigners holding a Degree in Law which has been acknowledged by a Faculty of Law in Portugal may register as members of the Bar Association provided they undergo the required training and pass the final assessment and admission exam. Legal consultation is allowed by jurists, provided they have their professional residence (\"domicilia\u00e7\u00e3o\") in PT, pass an admission exam and are registered in the Bar. In RO: A foreign lawyer may not make oral or written conclusions before the courts and other judicial bodies, except for international arbitration. In SE: (with respect also to Most-favoured-nation treatment) Without prejudice to the EU reservation above: A member of the Swedish Bar Association may not be employed by anyone other than a Bar member or a company conducting the business of a Bar member. However, a Bar member may be employed by a foreign company conducting the business of an advocate, provided that the company in question is domiciled in a country within the Union, the EEA or the Swiss Confederation. Subject to an exemption from the Board of the Swedish Bar Association, a member of the Swedish Bar Association may also be employed by a non-European Union law firm. Bar members conducting their practice in the form of a company or a partnership may not have any other objective and may not carry out any other business than the practice of an advocate. Collaboration with other advocate businesses is permitted, however, collaboration with foreign businesses requires permission by the Board of the Swedish Bar Association. Only a Bar member may directly or indirectly, or through a company, practise as an advocate, own shares in the company or be a partner. Only a member may be a member or deputy member of the Board or deputy managing director, or an authorised signatory or secretary of the company or the partnership. In SI: (with respect also to Most-favoured-nation treatment) A foreign lawyer who has the right to practise home-jurisdiction law may supply legal services or practise law under the conditions laid down in Article 34a of the Attorneys Act, provided the condition of actual reciprocity is fulfilled. Without prejudice to the EU reservation on non-discriminatory legal form requirements, commercial presence for appointed attorneys by the Slovene Bar Association is restricted to sole proprietorship, law firm with limited liability (partnership) or to a law firm with unlimited liability (partnership) only. The activities of a law firm shall be restricted to the practice of law. Only attorneys may be partners in a law firm. In SK: For non-EU lawyers actual reciprocity is required. (ii) Other legal services (host-jurisdiction law including legal advisory, arbitration, conciliation and mediation services and legal representational services). For greater certainty, consistent with the Headnotes, in particular paragraph 9, requirements to register with a Bar may include a requirement to have obtained a law degree in the host jurisdiction or its equivalent, or to have completed some training under the supervision of a licensed lawyer, or to have an office or a postal address within the jurisdiction of a specific Bar in order to be eligible to apply for membership in that Bar. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 National treatment, Local presence: In EU: Representation of natural or legal persons before the European Union Intellectual Property Office (EUIPO) may only be undertaken by a legal practitioner qualified in one of the Member States of the EEA and having their place of business within the EEA, to the extent that they are entitled, within the said Member State, to act as a representative in trade mark matters or in industrial property matters and by professional representatives whose names appear on the list maintained for this purpose by the EUIPO. (Part of CPC 861) In AT: EEA or Swiss nationality as well as residency (commercial presence) is required for the practice of legal services in respect of host jurisdiction (Union and Member State) law, including representation before courts. Only lawyers of EEA or Swiss nationality are allowed to provide legal services through commercial presence. The practice of legal services in respect of public international law and home-jurisdiction law is only allowed on a cross-border basis. Equity participation and shares in the operating result of any law firm by foreign lawyers (who must be fully qualified in their home-jurisdiction) is allowed up to 25 per cent; the rest must be held by fully qualified EEA or Swiss lawyers and only the latter may exercise decisive influence in the decision making of the law firm. In BE: (with respect also to Most-favoured-nation treatment) Residency is required for full admission to the Bar, including for representation before courts. The residency requirement for a foreign lawyer to obtain full admission to the Bar is at least six years from the date of application for registration, three years under certain conditions. Requirement to have a certificate issued by the Belgian Minister of Foreign Affairs under which the national law or international convention allows reciprocity (reciprocity condition). Foreign lawyers may practise as legal consultants. Lawyers who are members of foreign (non-EU) Bars and want to establish in Belgium but do not meet the conditions for registration on the Tableau of fully qualified lawyers, on the EU-list or on the List of Trainee Lawyers, may request registration on the so-called \"B-List\". Only at the Brussels Bar there exists such a \"B-List\". A lawyer on the B-list is allowed to give advice. Representation before \"the Cour de Cassation\" is subject to nomination on a specific list. In BG: (with respect also to Most-favoured-nation treatment) Reserved to nationals of a Member State, of another State which is a party to the Agreement on the EEA, or of the Swiss Confederation who has been granted authorisation to pursue the profession of lawyer according to the legislation of any of the aforementioned countries. A foreign national (except for the above mentioned) who has been authorised to pursue the profession of lawyer in accordance with the legislation of his or her own country, may appeal before judicial bodies of the Republic of Bulgaria as defence-counsel or mandatary of a national of his or her own country, acting on a specific case, together with a Bulgarian attorney-at-law, in cases where this has been envisaged in an agreement between the Bulgarian and the respective foreign state, or on the basis of mutuality, making a preliminary request to this effect to the Chairperson of the Supreme Bar Council. Countries, in respect of which mutuality exists, shall be designated by the Minister of Justice, upon request of the Chairperson of the Supreme Bar Council. In order to provide legal mediation services, a foreign national must have a permit for long-term or permanent residence in the Republic of Bulgaria and has been entered in the Uniform Register of Mediators with the Minister of Justice. In CY: EEA or Swiss nationality as well as residency (commercial presence) is required. Only advocates enrolled in the Bar may be partners or shareholders or members of the board of directors in a law company in Cyprus. In CZ: For foreign lawyers full admission to the Czech Bar Association and residence (commercial presence) is required. In DE: Only lawyers with EEA or Swiss qualification may be admitted to the Bar and are thus entitled to provide legal services. Commercial presence is required in order to obtain full admission to the Bar. Exemptions may be granted by the competent bar association. For foreign lawyers (with other than EEA and Swiss qualification) there may be restrictions for holding shares of a lawyers company which provides legal services in domestic law. In DK: Legal services provided under the title \"advokat\" (advocate) or any similar title, as well as representation before the courts, is reserved for advocates with a Danish license to practise. EU, EEA and Swiss advocates may practise under the title of their country of origin. Without prejudice to the EU reservation on non-discriminatory legal form requirements, shares of a law firm can only be owned by advocates who actively practise law in the firm, its parent company or its subsidiary company, other employees in the firm, or another law firm registered in Denmark. Other employees in the firm may collectively only own less than 10 per cent of the shares and of the voting rights, and in order to be shareholders they must pass an exam on the rules of particular importance for the practice of law. Only advocates who actively practise law in the firm, its parent company or its subsidiary company, other shareholders, and representatives of employees, may be members of the board. The majority of the members of the board must be advocates who actively practise law in the firm, its parent company or its subsidiary company. Only advocates who actively practise law in the firm, its parent company or its subsidiary company, and other shareholders having passed the exam mentioned above, may be a director of the law firm. In EE: Residency (commercial presence) is required. In EL: EEA or Swiss nationality and residency (commercial presence) is required In ES: EEA or Swiss nationality is required. The competent authorities may grant nationality waivers. In FI: EEA or Swiss residency and Bar membership is required for the use of the professional title of \"advocate\" (in Finnish \"asianajaja\" or in Swedish \"advokat\"). Legal services may also be provided by non-Bar members. In FR: Without prejudice to the EU reservation on non-discriminatory legal form requirements, residency or establishment in the EEA is required for full admission to the Bar, necessary for the practice of legal services. In a law firm, shareholding and voting rights may be subject to quantitative restrictions related to the professional activity of the partners. Representation before \"the Cour de Cassation\" and \"Conseil d'Etat\" is subject to quotas and reserved for FR and EU nationals. For all lawyers, company must take one of the following legal forms authorised under French law on a non-discriminatory basis: SCP (soci\u00e9t\u00e9 civile professionnelle), SEL (soci\u00e9t\u00e9 d'exercice lib\u00e9ral), SEP (soci\u00e9t\u00e9 en participation), SARL (soci\u00e9t\u00e9 \u00e0 responsabilit\u00e9 limit\u00e9e), SAS (soci\u00e9t\u00e9 par actions simplifi\u00e9e), SA (soci\u00e9t\u00e9 anonyme), SPE (soci\u00e9t\u00e9 pluriprofessionnelle d'exercice) and \"association\", under certain conditions. Residency or establishment in the EEA is required to practise on a permanent basis. In HR: European Union nationality is required. In HU: EEA or Swiss nationality and residency (commercial presence) is required. In LT: (With respect also to Most-favoured-nation treatment) EEA or Swiss nationality and residency (commercial presence) is required. Attorneys from foreign countries can practise as advocates in court only in accordance with international agreements, including specific provisions regarding representation before courts. Full admission to the Bar is required. In LU (with respect also to Most-favoured-nation treatment): EEA or Swiss nationality and residency (commercial presence) is required. The Council of the Order may, on the basis of reciprocity, agree to waive the nationality requirement for a foreign national. In LV (with respect also to Most-favoured-nation treatment): EEA or Swiss nationality is required. Attorneys from foreign countries can practise as advocates in court only in accordance with bilateral agreements on mutual legal assistance. For European Union or foreign advocates, special requirements exist. For example, participation in court proceedings in criminal cases is only permitted in association with an advocate of the Latvian Collegium of Sworn Advocates. In MT: EEA or Swiss nationality as well as residency (commercial presence) is required. In NL: Only locally-licensed lawyers registered in the Dutch registry can use the title \"advocate\". Instead of using the full term \"advocate\", (non-registered) foreign lawyers are obliged to mention their home-jurisdiction professional organisation for the purposes of their activities in the Netherlands. In PT (with respect also to Most-favoured-nation treatment): residency (commercial presence) is required. For representation before courts, full admission to the Bar is required. Foreigners holding a diploma awarded by any Faculty of Law in Portugal, may register with the Portuguese Bar (Ordem dos Advogados), under the same terms as Portuguese nationals, if their respective country grants Portuguese nationals reciprocal treatment. Other foreigners holding a Degree in Law which has been acknowledged by a Faculty of Law in Portugal may register as members of the Bar Association provided they undergo the required training and pass the final assessment and admission exam. Only law firms where the shares belong exclusively to lawyers admitted to the Portuguese Bar can practise in Portugal. In RO: A foreign lawyer may not make oral or written conclusions before the courts and other judicial bodies, except for international arbitration. In SE: (with respect also to Most-favoured-nation treatment) EEA or Swiss residency is required for admission to the Bar and use of the title of \"advokat\". Exemptions may be granted by the board of the Swedish Bar Association. Admission to the Bar is not necessary for the practice of Swedish law. Without prejudice to the EU reservation on non-discriminatory legal form requirements, a member of the Swedish Bar Association may not be employed by anyone other than a Bar member or a company conducting the business of a Bar member. However, a Bar member may be employed by a foreign company conducting the business of an advocate, provided that the company in question is domiciled in a country within the EEA or the Swiss Confederation. Subject to an exemption from the Board of the Swedish Bar Association, a member of the Swedish Bar Association may also be employed by a non-European Union law firm. Bar members conducting their practice in the form of a company or a partnership may not have any other objective and may not carry out any other business than the practice of an advocate. Collaboration with other advocate businesses is permitted, however, collaboration with foreign businesses requires permission by the Board of the Swedish Bar Association. Only a Bar member may directly or indirectly, or through a company, practise as an advocate, own shares in the company or be a partner. Only a member may be a member or deputy member of the Board or deputy managing director, or an authorised signatory or secretary of the company or the partnership. In SI: (with respect also to Most-favoured-nation treatment) Representing clients before the court against payment is conditioned by commercial presence in Republic of Slovenia. A foreign lawyer who has the right to practise home-jurisdiction law may perform legal services or practise law under the conditions laid down in Article 34a of the Attorneys Act, provided the condition of actual reciprocity is fulfilled. Without prejudice to the EU reservation on non-discriminatory legal form requirements, commercial presence for appointed attorneys by the Slovene Bar Association is restricted to sole proprietorship, law firm with limited liability (partnership) or to a law firm with unlimited liability (partnership) only. The activities of a law firm shall be restricted to the practice of law. Only attorneys may be partners in a law firm. In SK: (with respect also to Most-favoured-nation treatment) EEA nationality as well as residency (commercial presence) is required for the practice of legal services in respect of host-jurisdiction law, including representation before courts. For non-EU lawyers actual reciprocity is required. Measures: EU: Article 120 of Regulation (EU) 2017/1001 of the European Parliament and of the Council (2); Article 78 of Council Regulation (EC) No 6/2002 of 12 December 2001 (3). AT: Rechtsanwaltsordnung (Lawyers Act) - RAO, RGBl. Nr. 96/1868, Article 1 and \u00a7 21c. BE: Belgian Judicial Code (Articles 428-508); Royal Decree of 24 August 1970. BG: Attorney Law; Law for Mediation; and Law for the Notaries and Notarial Activity. CY: Advocates Law (Chapter 2), as amended. CZ: Act No. 85/1996 Coll., the Legal Profession Act. DE: \u00a7 59e, \u00a7 59f, \u00a7 206 Bundesrechtsanwaltsordnung (BRAO; Federal Lawyers Act); Gesetz \u00fcber die T\u00e4tigkeit europ\u00e4ischer Rechtsanw\u00e4lte in Deutschland (EuRAG); and \u00a7 10 Rechtsdienstleistungsgesetz (RDG). DK: Retsplejeloven (Administration of Justice Act) chapters 12 and 13 (Consolidated Act No. 1284 of 14 November 2018). EE: Advokatuuriseadus (Bar Association Act); Tsiviilkohtumenetluse seadustik (Code of Civil Procedure); halduskohtumenetluse seadustik (Code of Administrative Court Procedure); kriminaalmenetluse seadustik (Code of Criminal Procedure); and v\u00e4\u00e4rteomenetluse seadustik (Code of Misdemeanour Procedure). EL: New Lawyers' Code n. 4194/2013. ES: Estatuto General de la Abogac\u00eda Espa\u00f1ola, aprobado por Real Decreto 658/2001, Article 13.1a. FI: Laki asianajajista (Advocates Act) (496/1958), ss. 1 and 3; and Oikeudenk\u00e4ymiskaari (4/1734) (Code of Judicial Procedure). FR: Loi 71-1130 du 31 d\u00e9cembre 1971, Loi 90- 1259 du 31 d\u00e9cembre 1990, d\u00e9cret 91-1197 du 27 novembre 1991, and Ordonnance du 10 septembre 1817 modifi\u00e9e. HR: Legal Profession Act (OG 9/94, 117/08, 75/09, 18/11). HU: ACT LXXVIII of 2017 on the professional activities of Attorneys at Law. LT: Law on the Bar of the Republic of Lithuania of 18 March 2004 No. IX-2066 as last amended on 12 December 2017 by law No XIII-571. LU: Loi du 16 d\u00e9cembre 2011 modifiant la loi du 10 ao\u00fbt 1991 sur la profession d'avocat. LV: Criminal Procedure Law, s. 79; and Advocacy Law of the Republic of Latvia, s. 4. MT: Code of Organisation and Civil Procedure (Cap. 12). NL: Advocatenwet (Act on Advocates). PT: Law 145/2015, 9 set., alterada p/ Lei 23/2020, 6 jul. (art.o 194 substitu\u00eddo p/ art.o 201.o; e art.o 203.o substitu\u00eddo p/ art.o 213.o). Portuguese Bar Statute (Estatuto da Ordem dos Advogados) and Decree-Law 229/2004, Articles 5, 7 \u2013 9; Decree-law 88/2003, Articles 77 and 102; Solicitadores Public Professional Association Statute (Estatuto da C\u00e2mara dos Solicitadores), as amended by Law 49/2004, mas alterada p/ Lei 154/2015, 14 set; by Law 14/2006 and by Decree-Law n.o 226/2008 alterado p/ Lei 41/2013, 26 jun; Law 78/2001, Articles 31, 4 Alterada p/ Lei 54/2013, 31 jul.; Regulation of family and labour mediation (Ordinance 282/2010), alterada p/ Portaria 283/2018, 19 out; Law 21/2007 on criminal mediation, Article 12; Law 22/2013, 26 fev., alterada p/ Lei 17/2017, 16 maio, alterada pelo Decreto-Lei 52/2019, 17 abril. RO: Attorney Law; Law for Mediation; and Law for the Notaries and the Notarial Activity. SE: R\u00e4tteg\u00e5ngsbalken (The Swedish Code of Judicial Procedure) (1942:740); and Swedish Bar Association Code of Conduct adopted 29 August 2008. SI: Zakon o odvetni\u0161tvu (Neuradno pre\u010di\u0161\u010deno besedilo-ZOdv-NPB8 Dr\u017eavnega Zbora RS z dne 7 junij 2019 (Attorneys Act) unofficial consolidated text prepared by the Slovenian parliament from 7 June 2019). SK: Act 586/2003 on Advocacy, Articles 2 and 12. With respect to Investment liberalisation - Market access, National treatment: In PL: Foreign lawyers may establish only in the form of a registered partnership, a limited partnership or a limited joint-stock partnership. Measures: PL: Act of 5 July 2002 on the provision by foreign lawyers of legal assistance in the Republic of Poland, Article 19. With respect to Cross-Border Trade in Services \u2013 Market access In IE, IT: Residency (commercial presence) is required for the practice of legal services in respect of host-jurisdiction law, including representation before courts. Measures: IE: Solicitors Acts 1954-2011. IT: Royal Decree 1578/1933, Article 17 law on the legal profession. (b) Patent agents, industrial property agents, intellectual property attorneys (part of CPC 879, 861, 8613) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Local presence: In AT: EEA or Swiss nationality is required for the practice of patent agency services, residency there is required. In BG, and CY: EEA or Swiss nationality is required for the practice of patent agency services. In CY, residency is required. In DE: Only patent lawyers having German qualifications may be admitted to the Bar and are thus entitled to provide patent agent services in Germany in domestic law. Foreign patent lawyers can offer legal services in foreign law when they prove expert knowledge, registration is required for legal services in Germany. Foreign (other than EEA and Swiss qualification) patent lawyers may not establish a firm together with national patent lawyers. Foreign (other than EEA and Swiss) patent lawyers may have their commercial presence only in the form of a Patentanwalts-GmbH or Patentanwalts-AG by acquiring a minority share. In EE: Estonian or EU nationality as well as permanent residency is required for the practice of patent agency services. In ES and PT: EEA nationality is required for the practice of industrial property agent services. In FR: To be registered on the industrial property agent services list, establishment or residency in the EEA is required. EEA nationality is required for natural persons. To represent a client in front of the national intellectual property office, establishment in the EEA is required. Provision only through SCP (soci\u00e9t\u00e9 civile professionnelle), SEL (soci\u00e9t\u00e9 d'exercice lib\u00e9ral) or any other legal form, under certain conditions. Irrespective of the legal form, more than half of shares and voting rights must be held by EEA professionals. Law firms may be entitled to provide industrial property agent services (see reservation for legal services). With respect to Cross-border trade in services \u2013 Local presence: In FI and HU: EEA residency is required for the practice of patent agency services. In SI: Residency in Slovenia is required for a holder/applicant of registered rights (patents, trademarks, design protection). Alternatively, a patent agent or a trademark and design agent registered in Slovenia is required for the main purpose of services of process, notification, etc. Measures: AT: Patent Attorney Act (\u00a7\u00a7 2 and 16a). BG: Article 4 of the Ordinance for Representatives regarding Intellectual Property. CY: Advocates Law (Chapter 2), as amended. DE: Patentanwaltsordnung (PAO). EE: Patendivoliniku seadus (Patent Agents Act) \u00a7 2, \u00a7 14. ES: Ley 11/1986, de 20 de marzo, de Patentes de Invenci\u00f3n y Modelos de utilidad, Articles 155-157. FI: Tavaramerkkilaki (Trademarks Act) (7/1964); Laki auktorisoiduista teollisoikeusasiamiehist\u00e4 (Act on Authorised Industrial Property Attorneys) (22/2014); and Laki kasvinjalostajanoikeudesta (Plant Breeder's Right Act) 1279/2009; and Mallioikeuslaki (Registered Designs Act) 221/1971. FR: Code de la propri\u00e9t\u00e9 intellectuelle. HU: Act XXXII of 1995 on Patent Attorneys. PT: Decree-Law 15/95, as modified by Law 17/2010, by Portaria 1200/2010, Article 5, and by Portaria 239/2013; and Law 9/2009. SI: Zakon o industrijski lastnini (Industrial Property Act), Uradni list RS, \u0161t. 51/06 \u2013 uradno pre\u010di\u0161\u010deno besedilo in 100/13 and 23/20 (Official Gazette of the Republic of Slovenia, No. 51/06 \u2013 official consolidated text 100/13 and 23/20). With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 National Treatment, Local presence: In IE: For establishment, at least one of the directors, partners, managers or employees of a company to be registered as a patent or intellectual property attorney in Ireland. Cross-border basis requires EEA nationality and commercial presence, principal place of business in an EEA Member State, qualification under the law of an EEA Member State. Measures: IE: Section 85 and 86 of the Trade Marks Act 1996, as amended; Rule 51, Rule 51A and Rule 51B of the Trade Marks Rules 1996, as amended; Section 106 and 107 of the Patent Act 1992, as amended; and Register of Patent Agent Rules S.I. 580 of 2015. (c) Accounting and bookkeeping services (CPC 8621 other than auditing services, 86213, 86219, 86220) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Local presence: In AT: The capital interests and voting rights of foreign accountants, bookkeepers, qualified according to the law of their home country, in an Austrian enterprise may not exceed 25 per cent. The service supplier must have an office or professional seat in the EEA (CPC 862). In FR: Establishment or residency is required. Provision through any company form except SNC (Soci\u00e9t\u00e9 en nom collectif) and SCS (Soci\u00e9t\u00e9 en commandite simple). Specific conditions apply to SEL (soci\u00e9t\u00e9s d'exercice lib\u00e9ral), AGC (Association de gestion et comptabilit\u00e9) and SPE (Soci\u00e9t\u00e9 pluri-professionnelle d'exercice). (CPC 86213, 86219, 86220). In IT: Residence or business domicile is required for enrolment in the professional register, which is necessary for the provision of accounting and bookkeeping services (CPC 86213, 86219, 86220). In PT: (with respect also to Most-favoured-nation treatment): Residence or business domicile is required for enrolment in the professional register by the Chamber of Certified Accountants (Ordem dos Contabilistas Certificados), which is necessary for the provision of accounting services, provided that there is reciprocal treatment for Portuguese nationals. Measures: AT: Wirtschaftstreuhandberufsgesetz (Public Accountant and Auditing Profession Act, BGBl. I Nr. 58/1999), \u00a7 12, \u00a7 65, \u00a7 67, \u00a7 68 (1) 4; and Bilanzbuchhaltungsgesetz (BibuG), BGBL. I Nr. 191/2013, \u00a7\u00a7 7, 11, 28. FR: Ordonnance 45-2138 du 19 septembre 1945. IT: Legislative Decree 139/2005; and Law 248/2006. PT: Decree-Law n.o452/99, changed by Law n.o 139/2015, september 7th. With respect to Cross-border trade in services \u2013 Local presence: In SI: Establishment in the European Union is required in order to provide accounting and bookkeeping services (CPC 86213, 86219, 86220). Measures: SI: Act on services in the internal market, Official Gazette RS No 21/10. (d) Auditing services (CPC \u2013 86211, 86212 other than accounting and bookkeeping services) With respect to Investment liberalisation \u2013 National treatment, Most-favoured nation treatment and Cross-border trade in services \u2013 National treatment, Most-favoured nation treatment: In EU: Supply of statutory auditing services requires approval by the competent authorities of a Member State that may recognise the equivalence of the qualifications of an auditor who is a national of the United Kingdom or of any third country subject to reciprocity (CPC 8621). Measures: EU: Directive 2013/34/EU of the European Parliament and of the Council (4); and Directive 2006/43/EC of the European Parliament and of the Council (5). With respect to Investment liberalisation \u2013 Market access: In BG: Non-discriminatory legal form requirements may apply. Measures: BG: Independent Financial Audit Act. With respect to Investment liberalisation \u2013 Market access, National treatment, and Cross-border trade in services \u2013 Local presence: In AT: The capital interests and voting rights of foreign auditors, qualified according to the law of their home country, in an Austrian enterprise may not exceed 25 per cent. The service supplier must have an office or professional seat in the EEA. Measures: AT: Wirtschaftstreuhandberufsgesetz (Public Accountant and Auditing Profession Act, BGBl. I Nr. 58/1999), \u00a7 12, \u00a7 65, \u00a7 67, \u00a7 68 (1) 4. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Local presence: In DK: Provision of statutory auditing services requires Danish approval as an auditor. Approval requires residency in a Member State of the EEA. Voting rights in approved audit firms of auditors and audit firms not approved in accordance with regulation implementing the Directive 2006/43/EC based on Article 54(3)(g) of the Treaty on statutory audit must not exceed 10 per cent of the voting rights. In FR: (with respect also to Most-favoured-nation treatment) For statutory audits: establishment or residency is required. British nationals may provide statutory auditing services in France, subject to reciprocity. Provision through any company form except those in which partners are considered to be traders (\"commer\u00e7ants\"), such as SNC (Soci\u00e9t\u00e9 en nom collectif) and SCS (Soci\u00e9t\u00e9 en commandite simple). In PL: Establishment in the European Union is required in order to provide auditing services. Legal form requirements apply. Measures: DK: Revisorloven (The Danish Act on Approved Auditors and Audit Firms), Act No. 1287 of 20/11/2018. FR: Code de commerce PL: Act of 11 May 2017 on statutory auditors, audit firms and public oversight - Journal of Laws of 2017, item 1089. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In CY: Authorisation is required, subject to an economic needs test. Main criteria: the employment situation in the sub-sector. Professional associations (partnerships) between natural persons are permitted. In SK: Only an enterprise in which at least 60 per cent of capital interests or voting rights are reserved to Slovak nationals or nationals of a Member State may be authorised to carry out audits in the Slovak Republic. Measures: CY: Auditors Law of 2017 (Law 53(I)/2017). SK: Act No. 423/2015 on Statutory audit. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 National treatment, Local presence: In DE: Auditing companies (\"Wirtschaftspr\u00fcfungsgesellschaften\") may only adopt legal forms admissible within the EEA. General partnerships and limited commercial partnerships may be recognised as \"Wirtschaftspr\u00fcfungsgesellschaften\" if they are listed as trading partnerships in the commercial register on the basis of their fiduciary activities, Article 27 WPO. However, auditors from third countries registered in accordance with Article 134 WPO may carry out the statutory audit of annual fiscal statements or provide the consolidated financial statements of a company with its headquarters outside the Union, whose transferable securities are offered for trading in a regulated market. Measures: DE: Handelsgesetzbuch (HGB; Code of Commercial Law); Gesetz \u00fcber eine Berufsordnung der Wirtschaftspr\u00fcfer (Wirtschaftspr\u00fcferordnung - WPO; Public Accountant Act). With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 National treatment: In ES: statutory auditors must be a national of a Member State. This reservation does not apply to the auditing of non-European Union companies listed in a Spanish regulated market. Measures: ES: Ley 22/2015, de 20 de julio, de Auditor\u00eda de Cuentas (new Auditing Law: Law 22/2015 on Auditing services). With respect to Investment liberalisation \u2013 Market access, National treatment: In EE: Legal form requirements apply. The majority of the votes represented by the shares of an audit firm shall belong to sworn auditors subject to supervision of a competent authority of a EEA Member State, who have acquired their qualification in an EEA Member State, or to audit firms. At least three-fourths of the persons representing an audit firm on the basis of law shall have acquired their qualifications in an EEA Member State. Measures: EE: Auditors Activities Act (Audiitortegevuse seadus) \u00a7 76-77 With respect to Investment liberalisation \u2013 National treatment, Most-favoured nation treatment and Cross-border trade in services \u2013 Local presence: In SI Commercial presence is required. A third country audit entity may hold shares or form partnerships in Slovenian audit company provided that, under the law of the country in which the third-country audit entity is incorporated, Slovenian audit companies may hold shares or form partnership in an audit entity in that country (reciprocity requirement). Measures: SI: Auditing Act (ZRev-2), Official Gazette RS No 65/2008 (as last amended No 84/18); and Companies Act (ZGD-1), Official Gazette RS No 42/2006 (as last amended No 22/19 - ZPosS). With respect to Cross-border trade in services \u2013 Local presence: In BE: An establishment in Belgium is required where the professional activity will take place and where acts, documents and correspondence relating to it will be maintained, and to have at least one administrator or manager of the establishment approved as auditor. In FI: EEA residency required for at least one of the auditors of a Finnish Limited Liability company and of companies which are under the obligation to carry out an audit. An auditor must be a locally-licensed auditor or a locally-licensed audit firm. In HR: Auditing services may be provided only by legal persons established in Croatia or by natural persons resident in Croatia. In IT: Residency is required for the provision of auditing services by natural persons. In LT: Establishment in the EEA is required for the provision of auditing services. In SE: Only auditors approved in Sweden and auditing firms registered in Sweden may perform statutory auditing services. EEA residency is required. The titles of \"approved auditor\" and \"authorised auditor\" may only be used by auditors approved or authorised in Sweden. Auditors of co-operative economic associations and certain other enterprises who are not certified or approved accountants must be resident within the EEA, unless the Government, or a Government authority appointed by the Government, in a particular case allows otherwise. Measures: BE: Law of December 7th 2016 on the organization of the profession and the public supervision of auditors (Public Audit Act). FI: Tilintarkastuslaki (Auditing Act) (459/2007), Sectoral laws requiring the use of locally licensed auditors. HR: Audit Act (OG 146/05, 139/08, 144/12), Article 3. IT: Legislative Decree 58/1998, Articles 155, 158 and 161; Decree of the President of the Republic 99/1998; and Legislative Decree 39/2010, Article 2. LT: Law on Audit of 15 June 1999 No. VIII -1227 (a new version of 3 July 2008 No. X1676). SE: Revisorslagen (Auditors Act) (2001:883); Revisionslag (Auditing Act) (1999:1079); Aktiebolagslagen (Companies Act) (2005:551); Lag om ekonomiska f\u00f6reningar (The Co-operative Economic Associations Act) (2018:672); and Others, regulating the requirements to make use of approved auditors. (e) Taxation advisory services (CPC 863, not including legal advisory and legal representational services on tax matters, which are to be found legal services) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Local presence: In AT: The capital interests and voting rights of foreign tax advisors, qualified according to the law of their home country, in an Austrian enterprise may not exceed 25 per cent. The service supplier must have an office or professional seat in the EEA. Measures: AT: Wirtschaftstreuhandberufsgesetz (Public Accountant and Auditing Profession Act, BGBl. I Nr. 58/1999), \u00a7 12, \u00a7 65, \u00a7 67, \u00a7 68 (1) 4. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Local presence: In FR: Establishment or residency is required. Provision through any company form except SNC (Soci\u00e9t\u00e9 en nom collectif) and SCS (Soci\u00e9t\u00e9 en commandite simple). Specific conditions apply to SEL (soci\u00e9t\u00e9s d'exercice lib\u00e9ral), AGC (Association de gestion et comptabilit\u00e9) and SPE (Soci\u00e9t\u00e9 pluri-professionnelle d'exercice). Measures: FR: Ordonnance 45-2138 du 19 septembre 1945. With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 National treatment: In BG: Nationality of a Member State is required for tax advisors. Measures: BG: Accountancy Act; Independent Financial Audit Act; Income Taxes on Natural Persons Act; and Corporate Income Tax Act. With respect to Cross-border trade in services \u2013 Local presence: In HU: EEA residency is required for the supply of taxation advisory services. In IT: Residency is required. Measures: HU: Act 150 of 2017 on taxing; Government Decree 2018/263 on the registration and training of taxation advisory activities. IT: Legislative Decree 139/2005; and Law 248/2006. (f) Architecture and urban planning services, engineering and integrated engineering services (CPC 8671, 8672, 8673, 8674) With respect to Investment liberalisation \u2013 Market access: In FR: An architect may only establish in France in order to provide architectural services using one of the following legal forms (on a non-discriminatory basis): SA et SARL (soci\u00e9t\u00e9s anonymes, \u00e0 responsabilit\u00e9 limit\u00e9e), EURL (Entreprise unipersonnelle \u00e0 responsabilit\u00e9 limit\u00e9e), SCP (en commandite par actions), SCOP (Soci\u00e9t\u00e9 coop\u00e9rative et participative), SELARL (soci\u00e9t\u00e9 d'exercice lib\u00e9ral \u00e0 responsabilit\u00e9 limit\u00e9e), SELAFA (soci\u00e9t\u00e9 d'exercice lib\u00e9ral \u00e0 forme anonyme), SELAS (soci\u00e9t\u00e9 d'exercice lib\u00e9ral) or SAS (Soci\u00e9t\u00e9 par actions simplifi\u00e9e), or as individual or as a partner in an architectural firm (CPC 8671). Measures: FR: Loi 90-1258 relative \u00e0 l'exercice sous forme de soci\u00e9t\u00e9 des professions lib\u00e9rales; D\u00e9cret 95-129 du 2 f\u00e9vrier 1995 relatif \u00e0 l'exercice en commun de la profession d'architecte sous forme de soci\u00e9t\u00e9 en participation; D\u00e9cret 92-619 du 6 juillet 1992 relatif \u00e0 l'exercice en commun de la profession d'architecte sous forme de soci\u00e9t\u00e9 d'exercice lib\u00e9ral \u00e0 responsabilit\u00e9 limit\u00e9e SELARL, soci\u00e9t\u00e9 d'exercice lib\u00e9ral \u00e0 forme anonyme SELAFA, soci\u00e9t\u00e9 d'exercice lib\u00e9ral en commandite par actions SELCA; and Loi 77-2 du 3 janvier 1977. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In BG: Residency in the EEA or the Swiss Confederation is required for architecture, urban planning and engineering services provided by natural persons. Measures: BG: Spatial Development Act; Chamber of Builders Act; and Chambers of Architects and Engineers in Project Development Design Act. With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 National treatment: In HR: A design or project created by a foreign architect, engineer or urban planner must be validated by an authorised natural or legal person in Croatia with regard to its compliance with Croatian Law (CPC 8671, 8672, 8673, 8674). Measures: HR: Act on Physical Planning and Building Activities (OG 118/18, 110/19) Physical Planning Act (OG 153/13, 39/19). With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 National treatment, Local presence: In CY: Nationality and residency condition applies for the provision of architecture and urban planning services, engineering and integrated engineering services (CPC 8671, 8672, 8673, 8674). Measures: CY: Law 41/1962 as amended; Law 224/1990 as amended; and Law 29(I)2001 as amended. With respect to Cross-border trade in services \u2013 Local presence: In CZ: Residency in the EEA is required. In HU: EEA residency is required for the supply of the following services, insofar as they are being supplied by a natural person present in the territory of Hungary: architectural services, engineering services (only applicable to graduate trainees), integrated Engineering services and landscape architectural services (CPC 8671, 8672, 8673, 8674). In IT: residency or professional domicile/business address in Italy is required for enrolment in the professional register, which is necessary for the exercise of architectural and engineering services (CPC 8671, 8672, 8673, 8674). In SK: Residency in the EEA is required for registration in the professional chamber, which is necessary for the exercise of architectural and engineering services (CPC 8671, 8672, 8673, 8674). Measures: CZ: Act no. 360/1992 Coll. on practice of profession of authorised architects and authorised engineers and technicians working in the field of building constructions. HU: Act LVIII of 1996 on the Professional Chambers of Architects and Engineers. IT: Royal Decree 2537/1925 regulation on the profession of architect and engineer; Law 1395/1923; and Decree of the President of the Republic (D.P.R.) 328/2001. SK: Act 138/1992 on Architects and Engineers, Articles 3, 15, 15a, 17a and 18a. With respect to Cross-border trade in services \u2013 Market access, National treatment: In BE: the provision of architectural services includes control over the execution of the works (CPC 8671, 8674). Foreign architects authorised in their host countries and wishing to practice their profession on an occasional basis in Belgium are required to obtain prior authorisation from the Council of Order in the geographical area where they intend to practice their activity. Measures: BE: Law of February 20, 1939 on the protection of the title of the architect's profession; and Law of 26th June 1963, which creates the Order of Architects Regulations of December 16th, 1983 of ethics established by national Council in the Order of Architects (Approved by Article 1st of A.R. of April 18th, 1985, M.B., May 8th, 1985). Reservation No. 3 - Professional services (health related and retail of pharmaceuticals) Sector \u2013 sub-sector: Professional services \u2013 medical (including psychologists) and dental services; midwives, nurses, physiotherapists and paramedical personnel; veterinary services; retail sales of pharmaceutical, medical and orthopaedic goods and other services provided by pharmacists Industry classification: CPC 9312, 93191, 932, 63211 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Chapter/Section: Investment Liberalisation and Cross-Border Trade in Services Description: (a) Medical, dental, midwives, nurses, physiotherapists and para-medical services (CPC 852, 9312, 93191) With respect to Investment liberalisation \u2013 National treatment, Most favoured nation treatment and Cross-border trade in services \u2013 National treatment, Most favoured nation treatment: In IT: European Union nationality is required for the services provided by psychologists, foreign professionals may be allowed to practice based on reciprocity (part of CPC 9312). Measures: IT: Law 56/1989 on the psychologist profession. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market Access, National treatment, Local presence: In CY: Cypriot nationality and residency condition applies for the provision of medical (including psychologists), dental, midwives, nurses, physiotherapists and para-medical services. Measures: CY: Registration of Doctors Law (Chapter 250) as amended; Registration of Dentists Law (Chapter 249) as amended; Law 75(I)/2013 - Podologists; Law 33(I)/2008 as amended- Medical Physics; Law 34(I)/2006 as amended - Occupational Therapists; Law 9(I)/1996 as amended - Dental Technicians; Law 68(I)/1995 as amended - Psychologists; Law 16(I)/1992 as amended - Opticians; Law 23(I)/2011 as amended - Radiologists/Radiotherapists; Law 31(I)/1996 as amended - Dieticians/Nutritionists; Law 140/1989 as amended - Physiotherapists; and Law 214/1988 as amended - Nurses. With respect to Investment liberalisation \u2013 Market Access and Cross-border trade in services \u2013 Market access, Local presence: In DE (applies also to the regional level of government): Geographical restrictions may be imposed on professional registration, which apply to nationals and non-nationals alike. Doctors (including psychologists, psychotherapists, and dentists) need to register with the regional associations of statutory health insurance physicians or dentists (kassen\u00e4rztliche or kassenzahn\u00e4rztliche Vereinigungen), if they wish to treat patients insured by the statutory sickness funds. This registration can be subject to quantitative restrictions based on the regional distribution of doctors. For dentists this restriction does not apply. Registration is necessary only for doctors participating in the public health scheme. Non-discriminatory restrictions on the legal form of establishment required to provide these services may exist (\u00a7 95 SGB V). For midwives services, access is restricted to natural persons only. For medical and dental services, access is possible for natural persons, licensed medical care centres and mandated bodies. Establishment requirements may apply. Regarding telemedicine, the number of ICT (information and communications technology) - service suppliers may be limited to guarantee interoperability, compatibility and necessary safety standards. This is applied in a non-discriminatory way (CPC 9312, 93191). Measures: Bundes\u00e4rzteordnung (B\u00c4O; Federal Medical Regulation); Gesetz \u00fcber die Aus\u00fcbung der Zahnheilkunde (ZHG); Gesetz \u00fcber den Beruf der Psychotherapeutin und des Psychotherapeuten (PsychThG; Act on the Provision of Psychotherapy Services); Gesetz \u00fcber die berufsm\u00e4\u00dfige Aus\u00fcbung der Heilkunde ohne Bestallung (Heilpraktikergesetz); Gesetz \u00fcber das Studium und den Beruf von Hebammen(HebG); Gesetz \u00fcber die Pflegeberufe (PflBG); Sozialgesetzbuch F\u00fcnftes Buch (SGB V; Social Code, Book Five) - Statutory Health Insurance. Regional level: Heilberufekammergesetz des Landes Baden-W\u00fcrttemberg; Gesetz \u00fcber die Berufsaus\u00fcbung, die Berufsvertretungen und die Berufsgerichtsbarkeit der \u00c4rzte, Zahn\u00e4rzte, Tier\u00e4rzte, Apotheker sowie der Psychologischen Psychotherapeuten und der Kinder- und Jugendlichenpsychotherapeuten (Heilberufe-Kammergesetz - HKaG) in Bayern; Berliner Heilberufekammergesetz (BlnHKG); Heilberufsgesetz Brandenburg (HeilBerG); Bremisches Gesetz \u00fcber die Berufsvertretung, die Berufsaus\u00fcbung, die Weiterbildung und die Berufsgerichtsbarkeit der \u00c4rzte, Zahn\u00e4rzte, Psychotherapeuten, Tier\u00e4rzte und Apotheker (Heilberufsgesetz - HeilBerG); Heilberufsgesetz Mecklenburg-Vorpommern (Heilberufsgesetz M-V \u2013 HeilBerG); Heilberufsgesetz (HeilBG NRW); Heilberufsgesetz (HeilBG Rheinland-Pfalz); Gesetz \u00fcber die \u00f6ffentliche Berufsvertretung, die Berufspflichten, die Weiterbildung und die Berufsgerichtsbarkeit der \u00c4rzte/ \u00c4rztinnen, Zahn\u00e4rzte/ Zahn\u00e4rztinnen, psychologischen Psychotherapeuten/ Psychotherapeutinnen und Kinder- und Jugendlichenpsychotherapeuten/psychotherapeutinnen, Tier\u00e4rzte/Tier\u00e4rztinnen und Apotheker/Apothekerinnen im Saarland (Saarl\u00e4ndisches Heilberufekammergesetz - SHKG); Gesetz \u00fcber Berufsaus\u00fcbung, Berufsvertretungen und Berufsgerichtsbarkeit der \u00c4rzte, Zahn\u00e4rzte, Tier\u00e4rzte, Apotheker sowie der Psychologischen Psychotherapeuten und der Kinder und Jugendlichenpsychotherapeuten im Freistaat (S\u00e4chsisches Heilberufekammergesetz \u2013 S\u00e4chsHKaG)and Th\u00fcringer Heilberufegesetz. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, Local presence: In FR: While other types of legal form are also available for Union investors, foreign investors only have access to the legal forms of \"soci\u00e9t\u00e9 d'exercice liberal\"(SEL) and \"soci\u00e9t\u00e9 civile professionnelle\" (SCP). For medical, dental and midwives services, French nationality is required. However, access by foreigners is possible within annually established quotas. For medical, dental and midwives services and services by nurses, provision through SEL \u00e0 forme anonyme, \u00e0 responsabilit\u00e9 limit\u00e9e par actions simplifi\u00e9e ou en commandite par actions SCP, soci\u00e9t\u00e9 coop\u00e9rative (for independent general and specialised practitioners only) or soci\u00e9t\u00e9 interprofessionnelle de soins ambulatoires (SISA) for multidisciplinary health home (MSP) only. Measures: FR: Loi 90-1258 relative \u00e0 l'exercice sous forme de soci\u00e9t\u00e9 des professions lib\u00e9rales, Loi n\u00b02011-940 du 10 ao\u00fbt 2011 modifiant certaines dipositions de la loi n\u00b02009-879 dite HPST, Loi n\u00b047-1775 portant statut de la coop\u00e9ration; and Code de la sant\u00e9 publique. With respect to Investment liberalisation \u2013 Market access: In AT: Cooperation of physicians for the purpose of ambulatory public healthcare, so-called group practices, can take place only under the legal form of Offene Gesellschaft/OG or Gesellschaft mit beschr\u00e4nkter Haftung/GmbH. Only physicians may act as associates of such a group practice. They must be entitled to independent medical practice, registered with the Austrian Medical Chamber and actively pursue the medical profession in the practice. Other natural or legal persons may not act as associates of the group practice and may not take share in its revenues or profits (part of CPC 9312). Measures: AT: Medical Act, BGBl. I Nr. 169/1998, \u00a7\u00a7 52a - 52c; Federal Act Regulating High Level Allied Health Professions, BGBl. Nr. 460/1992; and Federal Act regulating Medical Masseurs lower and upper level, BGBl. Nr. 169/2002. (b) Veterinary services (CPC 932) With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services \u2013 Market access, National treatment, Most-favoured nation treatment: In AT: Only nationals of a Member State of the EEA may provide veterinary services. The nationality requirement is waived for nationals of a non-Member State of the EEA where there is a Union agreement with that non-Member State of the EEA providing for national treatment with respect to investment and cross-border trade of veterinary services. In ES: Membership in the professional association is required for the practice of the profession and requires Union nationality, which may be waived through a bilateral professional agreement. The provision of veterinary services is restricted to natural persons. In FR: EEA nationality is required for the supply of veterinary services, but the nationality requirement may be waived subject to reciprocity. The legal forms available to a company providing veterinary services are limited to SCP (Soci\u00e9t\u00e9 civile professionnelle) and SEL (Soci\u00e9t\u00e9 d'exercice liberal). Other legal forms of company provided for by French domestic law or the law of another Member State of the EEA and having their registered office, central administration or principal place of business therein may be authorised, under certain conditions. Measures: AT: Tier\u00e4rztegesetz (Veterinary Act), BGBl. Nr. 16/1975, \u00a73 (2) (3). ES: Real Decreto 126/2013, de 22 de febrero, por el que se aprueban los Estatutos Generales de la Organizaci\u00f3n Colegial Veterinaria Espa\u00f1ola; Articles 62 and 64. FR: Code rural et de la p\u00eache maritime. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 National treatment, Local presence: In CY: Nationality and residency condition applies for the provision of veterinary services. In EL: EEA or Swiss nationality is required for the supply of veterinary services. In HR: Only legal and natural persons established in a Member State for the purpose of conducting veterinary activities can supply cross border veterinary services in the Republic of Croatia. Only Union nationals can establish a veterinary practice in the Republic of Croatia. In HU: EEA nationality is required for membership of the Hungarian Veterinary Chamber, necessary for supplying veterinary services. Authorisation for establishment is subject to an economic needs test. Main criteria: labour market conditions in the sector. Measures: CY: Law 169/1990 as amended. EL: Presidential Degree 38/2010, Ministerial Decision 165261/IA/2010 (Gov. Gazette 2157/B). HR: Veterinary Act (OG 83/13, 148/13, 115/18), Articles 3 (67), Articles 105 and 121. HU: Act CXXVII of 2012 on the Hungarian Veterinary Chamber and on the conditions how to supply Veterinary services. With respect to Cross-border trade in services \u2013 Local presence: In CZ: Physical presence in the territory is required for the supply of veterinary services. In IT and PT: Residency is required for the supply of veterinary services. In PL: Physical presence in the territory is required for the supply of veterinary services to pursue the profession of veterinary surgeon present in the territory of Poland, non- European Union nationals have to pass an exam in Polish language organized by the Polish Chambers of Veterinary Surgeons. In SI: Only legal and natural persons established in a Member State for the purpose of conducting veterinary activities can supply cross border veterinary services in to the Republic of Slovenia. With respect to Investment liberalisation \u2013 Market acces, and Cross-border trade in services \u2013Market access: In SK: Residency in the EEA is required for registration in the professional chamber, which is necessary for the exercise of the profession. The provision of veterinary services is restricted to natural persons. Measures: CZ: Act No. 166/1999 Coll. (Veterinary Act), \u00a758-63, 39; and Act No. 381/1991 Coll. (on the Chamber of Veterinary Surgeons of the Czech Republic), paragraph 4. IT: Legislative Decree C.P.S. 233/1946, Articles 7-9; and Decree of the President of the Republic (DPR) 221/1950, paragraph 7. PL: Law of 21st December 1990 on the Profession of Veterinary Surgeon and Chambers of Veterinary Surgeons. PT: Decree-Law 368/91 (Statute of the Veterinary Professional Association) alterado p/ Lei 125/2015, 3 set. SI Pravilnik o priznavanju poklicnih kvalifikacij veterinarjev (Rules on recognition of professional qualifications for veterinarians), Uradni list RS, \u0161t. (Official Gazette No) 71/2008, 7/2011, 59/2014 in 21/2016, Act on services in the internal market, Official Gazette RS No 21/2010. SK: Act 442/2004 on Private Veterinary Doctors and the Chamber of Veterinary Doctors, Article 2. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access: In DE (applies also to the regional level of government): The supply of veterinary services is restricted to natural persons. Telemedicine may only be provided in the context of a primary treatment involving the prior physical presence of a veterinary. In DK and NL: The supply of veterinary services is restricted to natural persons. In IE: The supply of veterinary services is restricted to natural persons or partnerships. In LV: The supply of veterinary services is restricted to natural persons. Measures: DE: Bundes-Tier\u00e4rzteordnung (BT\u00c4O; Federal Code for the Veterinary Profession). Regional level: Acts on the Councils for the Medical Profession of the L\u00e4nder (Heilberufs- und Kammergesetze der L\u00e4nder) and (based on these) Baden-W\u00fcrttemberg, Gesetz \u00fcber das Berufsrecht und die Kammern der \u00c4rzte, Zahn\u00e4rzte, Tier\u00e4rzte Apotheker, Psychologischen Psychotherapeuten sowie der Kinder- und Jugendlichenpsychotherapeuten (Heilberufe-Kammergesetz - HBKG); Bayern, Gesetz \u00fcber die Berufsaus\u00fcbung, die Berufsvertretungen und die Berufsgerichtsbarkeit der \u00c4rzte, Zahn\u00e4rzte, Tier\u00e4rzte, Apotheker sowie der Psychologischen Psychotherapeuten und der Kinder- und Jugendlichenpsychotherapeuten (Heilberufe-Kammergesetz - HKaG); Berliner Heilberufekammergesetz (BlnHKG); Brandenburg, Heilberufsgesetz (HeilBerG); Bremen, Gesetz \u00fcber die Berufsvertretung, die Berufsaus\u00fcbung, die Weiterbildung und die Berufsgerichtsbarkeit der \u00c4rzte, Zahn\u00e4rzte, Psychotherapeuten, Tier\u00e4rzte und Apotheker (Heilberufsgesetz - HeilBerG); Hamburg, Hamburgisches Kammergesetz f\u00fcr die Heilberufe (HmbKGH); Hessen, Gesetz \u00fcber die Berufsvertretungen, die Berufsaus\u00fcbung, die Weiterbildung und die Berufsgerichtsbarkeit der \u00c4rzte, Zahn\u00e4rzte, Tier\u00e4rzte, Apotheker, Psychologischen Psychotherapeuten und Kinder- und Jugendlichenpsychotherapeuten (Heilberufsgesetz); Mecklenburg-Vorpommern, Heilberufsgesetz (HeilBerG); Niedersachsen, Kammergesetz f\u00fcr die Heilberufe (HKG); Nordrhein-Westfalen, Heilberufsgesetz NRW (HeilBerg); Rheinland-Pfalz, Heilberufsgesetz (HeilBG); Saarland, Gesetz Nr. 1405 \u00fcber die \u00f6ffentliche Berufsvertretung, die Berufspflichten, die Weiterbildung und die Berufsgerichtsbarkeit der \u00c4rzte/\u00c4rztinnen, Zahn\u00e4rzte/Zahn\u00e4rztinnen, Tier\u00e4rzte/Tier\u00e4rztinnen und Apotheker/Apothekerinnen im Saarland (Saarl\u00e4ndisches Heilberufekammergesetz - SHKG); Sachsen, Gesetz \u00fcber Berufsaus\u00fcbung, Berufsvertretungen und Berufsgerichtsbarkeit der \u00c4rzte, Zahn\u00e4rzte, Tier\u00e4rzte, Apotheker sowie der Psychologischen Psychotherapeuten und der Kinder- und Jugendlichenpsychotherapeuten im Freistaat Sachsen (S\u00e4chsisches Heilberufekammergesetz \u2013 S\u00e4chsHKaG); Sachsen-Anhalt, Gesetz \u00fcber die Kammern f\u00fcr Heilberufe Sachsen-Anhalt (KGHB-LSA); Schleswig-Holstein, Gesetz \u00fcber die Kammern und die Berufsgerichtsbarkeit f\u00fcr die Heilberufe (Heilberufekammergesetz - HBKG); Th\u00fcringen, Th\u00fcringer Heilberufegesetz (Th\u00fcrHeilBG); and Berufsordnungen der Kammern (Codes of Professional Conduct of the Veterinary Practitioners' Councils). DK: Lovbekendtg\u00f8relse nr. 40 af lov om dyrl\u00e6ger af 15. januar 2020 (Consolidated act no. 40 of January 15th, 2020, on veterinary surgeons). IE: Veterinary Practice Act 2005. LV: Veterinary Medicine Law. NL: Wet op de uitoefening van de diergeneeskunde 1990 (WUD). (c) Retail sales of pharmaceuticals, medical and orthopaedic goods and other services provided by pharmacists (CPC 63211) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors: In AT: The retail of pharmaceuticals and specific medical goods to the public may only be carried out through a pharmacy. Nationality of a Member State of the EEA or the Swiss Confederation is required in order to operate a pharmacy. Nationality of a Member State of the EEA or the Swiss Confederation is required for leaseholders and persons in charge of managing a pharmacy. Measures: AT: Apothekengesetz (Pharmacy Law), RGBl. Nr. 5/1907 as amended, \u00a7\u00a7 3, 4, 12; Arzneimittelgesetz (Medication Act), BGBl. Nr. 185/1983 as amended, \u00a7\u00a7 57, 59, 59a; and Medizinproduktegesetz (Medical Products Law), BGBl. Nr. 657/1996 as amended, \u00a7 99. With respect to Investment liberalisation \u2013 Market Access, National Treatment: In DE: Only natural persons (pharmacists) are permitted to operate a pharmacy. Nationals of other countries or persons who have not passed the German pharmacy exam may only obtain a licence to take over a pharmacy which has already existed during the preceding three years. The total number of pharmacies per person is restricted to one pharmacy and up to three branch pharmacies. In FR: EEA or Swiss nationality is required in order to operate a pharmacy. Foreign pharmacists may be permitted to establish within annually established quotas. Pharmacy opening must be authorised and commercial presence including sale at a distance of medicinal products to the public by means of information society services, must take one of the legal forms which are allowed under national law on a non-discriminatory basis: soci\u00e9t\u00e9 d'exercice lib\u00e9ral (SEL) anonyme, par actions simplifi\u00e9e, \u00e0 responsabilit\u00e9 limit\u00e9e unipersonnelle or pluripersonnelle, en commandite par actions, soci\u00e9t\u00e9 en noms collectifs (SNC) or soci\u00e9t\u00e9 \u00e0 responsabilit\u00e9 limit\u00e9e (SARL) unipersonnelle or pluripersonnelle only. Measures: DE: Gesetz \u00fcber das Apothekenwesen (ApoG; German Pharmacy Act); Gesetz \u00fcber den Verkehr mit Arzneimitteln (AMG); Gesetz \u00fcber Medizinprodukte (MPG); Verordnung zur Regelung der Abgabe von Medizinprodukten (MPAV) FR: Code de la sant\u00e9 publique; and Loi 90-1258 du 31 d\u00e9cembre 1990 relative \u00e0 l'exercice sous forme de soci\u00e9t\u00e9 des professions lib\u00e9rales and Loi 2015-990 du 6 ao\u00fbt 2015. With respect to Investment liberalisation \u2013 National Treatment: In EL: European Union nationality is required in order to operate a pharmacy. In HU: EEA nationality is required in order to operate a pharmacy. In LV: In order to commence independent practice in a pharmacy, a foreign pharmacist or pharmacist's assistant, educated in a state which is not a Member State or a Member State of the EEA, must work for at least one year in a pharmacy in a Member State of the EEA under the supervision of a pharmacist. Measures: EL: Law 5607/1932 as amended by Laws 1963/1991 and 3918/2011. HU: Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products. LV: Pharmaceutical Law, s. 38. With respect to Investment liberalisation \u2013 Market access: In BG: Managers of pharmacies must be qualified pharmacists and may only manage one pharmacy in which they themselves work. A quota (not more than 4) exists for the number of pharmacies which may be owned per person in the Republic of Bulgaria. In DK: Only natural persons, who have been granted a pharmacist licence from the Danish Health and Medicines Authority, are permitted to provide retail services of pharmaceuticals and specific medical goods to the public. In ES, HR, HU, and PT: Establishment authorisation is subject to an economic needs test. Main criteria: population and density conditions in the area. In IE: The mail order of pharmaceuticals is prohibited, with the exception of non-prescription medicines. In MT: Issuance of Pharmacy licences under specific restrictions. No person shall have more than one licence in his name in any town or village (Regulation 5(1) of the Pharmacy Licence Regulations (LN279/07)), except in the case where there are no further applications for that town or village (Regulation 5(2) of the Pharmacy Licence Regulations (LN279/07)). In PT: In commercial companies where the capital is represented by shares, these shall be nominative. A person shall not hold or exercise, at the same time, directly or indirectly, ownership, operation or management of more than four pharmacies. In SI The network of pharmacies in Slovenia consists of public pharmacy institutions, owned by municipalities, and of private pharmacists with concession where the majority owner must be a pharmacist by profession. Mail order of pharmaceuticals requiring a prescription is prohibited. Mail order of non-prescription medicines requires special state permission. Measures: BG: Law on Medicinal Products in Human Medicine, arts. 222, 224, 228. DK: Apotekerloven (Danish Pharmacy Act) LBK nr. 801 12/06/2018. ES: Ley 16/1997, de 25 de abril, de regulaci\u00f3n de servicios de las oficinas de farmacia (Law 16/1997, of 25 April, regulating services in pharmacies), Articles 2, 3.1; and Real Decreto Legislativo 1/2015, de 24 de julio por el que se aprueba el Texto refundido de la Ley de garant\u00edas y uso racional de los medicamentos y productos sanitarios (Ley 29/2006). HR: Health Care Act (OG 100/18, 125/19). HU: Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products. IE: Irish Medicines Boards Acts 1995 and 2006 (No. 29 of 1995 and No. 3 of 2006); Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended (S.I. 540 of 2003); Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended (S.I. 540 of 2007); Pharmacy Act 2007 (No. 20 of 2007); Regulation of Retail Pharmacy Businesses Regulations 2008, as amended, (S.I. No 488 of 2008). MT: Pharmacy Licence Regulations (LN279/07) issued under the Medicines Act (Cap. 458). PT: Decree-Law 307/2007, Articles 9, 14 and 15 Alterado p/ Lei 26/2011, 16 jun., alterada: \u2014 p/ Ac\u00f3rd\u00e3o TC 612/2011, 24/01/2012, \u2014 p/ Decreto-Lei 171/2012, 1 ago., \u2014 p/ Lei 16/2013, 8 fev., \u2014 p/ Decreto-Lei 128/2013, 5 set., \u2014 p/ Decreto-Lei 109/2014, 10 jul., \u2014 p/ Lei 51/2014, 25 ago., \u2014 p/ Decreto-Lei 75/2016, 8 nov.; and Ordinance 1430/2007revogada p/ Portaria 352/2012, 30 out. SI Pharmacy Services Act (Official Gazette of the RS No. 85/2016, 77/2017, 73/2019); and Medicinal Products Act (Official Gazette of the RS, No. 17/2014, 66/2019). With respect to Investment liberalisation \u2013 Market Access, National treatment, Most-Favoured Nation treatment and Cross-border trade in services \u2013 Market access, National treatment: In IT: The practice of the profession is possible only for natural persons enrolled in the register, as well as for legal persons in the form of partnerships, where every partner of the company must be an enrolled pharmacist. Enrolment in the pharmacist professional register requires nationality of a Member State of the European Union or residency and the practice of the profession in Italy. Foreign nationals having the necessary qualifications may enrol if they are citizens of a country with whom Italy has a special agreement, authorising the exercise of the profession, under condition of reciprocity (D. Lgsl. CPS 233/1946 Articles 7-9 and D.P.R. 221/1950 paragraphs 3 and 7). New or vacant pharmacies are authorised following a public competition. Only nationals of a Member State of the European Union enrolled in the Register of pharmacists (\"albo\") are able to participate in a public competition. Establishment authorisation is subject to an economic needs test. Main criteria: population and density conditions in the area. Measures: IT: Law 362/1991, Articles 1, 4, 7 and 9; Legislative Decree CPS 233/1946, Articles 7-9; and Decree of the President of the Republic (D.P.R. 221/1950, paragraphs 3 and 7). With respect to Investment liberalisation \u2013 Market Access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In CY: Nationality requirement applies for the provision of retail sales of pharmaceuticals, medical and orthopaedic goods and other services provided by pharmacists (CPC 63211). Measures: CY: Pharmacy and Poisons Law (Chapter 254) as amended. With respect to Investment liberalisation \u2013 Market access and Cross-border services \u2013 Market access: In BG The retail of pharmaceuticals and specific medical goods to the public may only be carried out through a pharmacy. The mail order of pharmaceuticals is prohibited, with the exception of non-prescription medicines. In EE: The retail of pharmaceuticals and specific medical goods to the public may only be carried out through a pharmacy. Mail order sale of medicinal products as well as delivery by post or express service of medicinal products ordered through the Internet is prohibited. Establishment authorisation is subject to an economic needs test. Main criteria: density conditions in the area. In EL: Only natural persons, who are licenced pharmacists, and companies founded by licenced pharmacists, are permitted to provide retail services of pharmaceuticals and specific medical goods to the public. In ES: Only natural persons, who are licenced pharmacists, are permitted to provide retail services of pharmaceuticals and specific medical goods to the public. Each pharmacist cannot obtain more than one licence. In LU: Only natural persons are permitted to provide retail services of pharmaceuticals and specific medical goods to the public. In NL: Mail order of medicine is subject to requirements. Measures: BG: Law on Medicinal Products in Human Medicine, arts.219, 222, 228, 234(5). EE: Ravimiseadus (Medicinal Products Act), RT I 2005, 2, 4; \u00a7 29 (2) and \u00a7 41 (3); and Tervishoiuteenuse korraldamise seadus (Health Services Organisation Act, RT I 2001, 50, 284). EL: Law 5607/1932 as amended by Laws 1963/1991 and 3918/2011. ES: Ley 16/1997, de 25 de abril, de regulaci\u00f3n de servicios de las oficinas de farmacia (Law 16/1997, of 25 April, regulating services in pharmacies), Articles 2, 3.1; and Real Decreto Legislativo 1/2015, de 24 de julio por el que se aprueba el Texto refundido de la Ley de garant\u00edas y uso racional de los medicamentos y productos sanitarios (Ley 29/2006). LU: Loi du 4 juillet 1973 concernant le r\u00e9gime de la pharmacie (annex a043); R\u00e8glement grand-ducal du 27 mai 1997 relatif \u00e0 l'octroi des concessions de pharmacie (annex a041); and R\u00e8glement grand-ducal du 11 f\u00e9vrier 2002 modifiant le r\u00e8glement grand-ducal du 27 mai 1997 relatif \u00e0 l'octroi des concessions de pharmacie (annex a017). NL: Geneesmiddelenwet, article 67. With respect to Investment liberalisation \u2013 National treatment and Cross-border services \u2013 Local presence: In BG: Permanent residency is required for pharmacists. Measures: BG: Law on Medicinal Products in Human Medicine, arts. 146, 161, 195, 222, 228. With respect to Cross-border trade in services \u2013 Local presence: In DE, SK: Residency is required in order to obtain a licence as a pharmacist or to open a pharmacy for the retail of pharmaceuticals and certain medical goods to the public. Measures: DE: Gesetz \u00fcber das Apothekenwesen (ApoG; German Pharmacy Act); Gesetz \u00fcber den Verkehr mit Arzneimitteln (AMG); Gesetz \u00fcber Medizinprodukte (MPG); Verordnung zur Regelung der Abgabe von Medizinprodukten (MPAV). SK: Act 362/2011 on pharmaceuticals and medical devices, Article 6; and Act 578/2004 on healthcare providers, medical employees, professional organisation in healthcare. Reservation No. 4 - Research and development services Sector \u2013 sub-sector: Research and development (R&D) services Industry classification: CPC 851, 853 Type of reservation: Market access National treatment Chapter: Investment liberalisation and Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: The EU: For publicly funded research and development (R&D) services benefitting from funding provided by the Union at the Union level, exclusive rights or authorisations may only be granted to nationals of the Member States and to legal persons of the Union having their registered office, central administration or principal place of business in the Union (CPC 851, 853). For publicly funded R&D services benefitting from funding provided by a Member State exclusive rights or authorisations may only be granted to nationals of the Member State concerned and to legal persons of the Member State concerned having their headquarters in that Member State (CPC 851, 853). This reservation is without prejudice to Part Five of this Agreement and to the exclusion of procurement by a Party or subsidies, in Article 123(6) and (7) of this Agreement. Measures: EU: All currently existing and all future Union research or innovation framework programmes, including the Horizon 2020 Rules for Participation and regulations pertaining to Joint Technology Initiatives (JTIs), Article 185 Decisions, and the European Institute for Innovation and Technology (EIT), as well as existing and future national, regional or local research programmes. Reservation No. 5 - Real estate services Sector \u2013 sub-sector: Real estate services Industry classification: CPC 821, 822 Type of reservation: Market access National treatment Most-favoured nation treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 National treatment, Local presence: In CY: For the supply of real estate services, nationality and residency condition applies. Measures: CY: The Real Estate Agents Law 71(1)/2010 as amended. With respect to Cross-border trade in services \u2013 Local presence: In CZ: Residency for natural persons and establishment for legal persons in the Czech Republic are required to obtain the licence necessary for the provision of real estate services. In HR: Commercial presence in EEA is required to supply real estate services. In PT: EEA residency is required for natural persons. EEA incorporation is required for legal persons. Measures: CZ: Trade Licensing Act. HR: Real Estate Brokerage Act (OG 107/07 and 144/12), Article 2. PT: Decree-Law 211/2004 (Articles 3 and 25), as amended and republished by Decree-Law 69/2011. With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 Local presence: In DK: For the supply of real estate services by a natural person present in the territory of Denmark, only authorised real estate agent who are natural persons that have been admitted to the Danish Business Authority's real estate agent register may use the title of \"real estate agent\". The act requires that the applicant be a Danish resident or a resident of the Union, EEA or the Swiss Confederation. The Act on the sale of real estate is only applicable when providing real estate services to consumers. The Act on the sale of real estate does not apply to the leasing of real estate (CPC 822). Measures: DK: Lov om formidling af fast ejendom m.v. lov. nr. 526 af 28.05.2014 (The Act on the sale of real estate). With respect to Cross-border trade in services \u2013 Market access, National treatment, Most-favoured-nation treatment: In SI: In so far as the United Kingdom allows Slovenian nationals and enterprises to supply real estate agent services, Slovenia will allow nationals of the United Kingdom and enterprises to supply real estate agent services under the same conditions, in addition to the fulfilment of the following requirements: entitlement to act as a real estate agent in the country of origin, submission of the relevant document on impunity in criminal procedures, and inscription into the registry of real estate agents at the competent (Slovenian) ministry. Measures: SI: Real Estate Agencies Act. Reservation No. 6 - Business services Sector \u2013 sub-sector: Business services - rental or leasing services without operators; services related to management consulting; technical testing and analyses; related scientific and technical consulting services; services incidental to agriculture; security services; placement services; translation and interpretation services and other business services Industry classification: ISIC Rev. 37, part of CPC 612, part of 621, part of 625, 831, part of 85990, 86602, 8675, 8676, 87201, 87202, 87203, 87204, 87205, 87206, 87209, 87901, 87902, 87909, 88, part of 893 Type of reservation: Market access National treatment Most-favoured nation treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Rental or leasing services without operators (CPC 83103, CPC 831) With respect to Investment liberalisation \u2013 Market access, National treatment: In SE: To fly the Swedish flag, proof of dominating Swedish operating influence must be shown in case of foreign ownership interests in ships. Dominating Swedish operating influence means that the operation of the ship is located in Sweden and that the ship also has a more than half of the shares of either Swedish ownership or ownership of persons in another EEA country. Other foreign ships may under certain conditions be granted an exemption from this rule where they are rented or leased by Swedish legal persons through bareboat charter contracts (CPC 83103). Measures: SE: Sj\u00f6lagen (Maritime Law) (1994:1009), Chapter 1, \u00a7 1. With respect to Cross-border trade in services \u2013 Local presence: In SE: Suppliers of rental or leasing services of cars and certain off-road vehicles (terr\u00e4ngmotorfordon) without a driver, rented or leased for a period of less than one year, are obliged to appoint someone to be responsible for ensuring, among other things, that the business is conducted in accordance with applicable rules and regulations and that the road traffic safety rules are followed. The responsible person must reside in the EEA (CPC 831). Measures: SE: Lag (1998: 424) om biluthyrning (Act on renting and leasing cars). (b) Rental or leasing services and other business services related to aviation With respect to Investment liberalisation - Market access, National treatment, Most-favoured nation treatment, and Cross-border trade in services - Market access, National treatment, Most-favoured-nation treatment: The EU: For rental or leasing of aircraft without crew (dry lease), aircraft used by an air carrier of the Union are subject to applicable aircraft registration requirements. A dry lease agreement to which a Union carrier is a party shall be subject to requirements in the Union or national law on aviation safety, such as prior approval and other conditions applicable to the use of third countries' registered aircraft. To be registered, aircraft may be required to be owned either by natural persons meeting specific nationality criteria or by enterprises meeting specific criteria regarding ownership of capital and control (CPC 83104). With respect to computer reservation system (CRS) services, where Union air carriers are not accorded, by CRS services suppliers operating outside the Union, equivalent (meaning non-discriminatory) treatment to the treatment provided by Union CRS service suppliers to air carriers of a third country in the Union, or where Union CRS services suppliers are not accorded, by non-Union air carriers, equivalent treatment to the treatment provided by air carriers in the Union to CRS service suppliers of a third country, measures may be taken to accord the equivalent discriminatory treatment, respectively, to the non-Union air carriers by the CRS services suppliers operating in the Union, or to the non-Union CRS services suppliers by Union air carriers. Measures: EU: Regulation (EC) No 1008/2008 of the European Parliament and of the Council (6); and Regulation (EC) No 80/2009 of the European Parliament and of the Council (7). With respect to Investment liberalisation - National treatment and Cross-border trade in services - Market access, National treatment In BE: Private (civil) aircraft belonging to natural persons who are not nationals of a member state of the EEA may only be registered if they are domiciled or resident in Belgium without interruption for at least one year. Private (civil) aircraft belonging to foreign legal entities not formed in accordance with the law of a member state of the EEA may only be registered if they have a seat of operations, an agency or an office in Belgium without interruption for at least one year (CPC 83104). Authorisation procedures for aerial fire-fighting, flight training, spraying, surveying, mapping, photography, and other airborne agricultural, industrial and inspection services. Measures: BE: Arr\u00eat\u00e9 Royal du 15 mars 1954 r\u00e9glementant la navigation a\u00e9rienne. (c) Services related to management consulting \u2013 arbitration and conciliation services (CPC 86602) With respect to Cross-border trade in services \u2013National treatment, Local presence: In BG: For mediation services, permanent or long-term residency in the republic of Bulgaria is required for citizens of countries other than a member state of the EEA or the Swiss Confederation. In HU: A notification, for admission into the register, to the minister responsible for justice is required for the pursuit of mediation (such as conciliation) activities. Measures: BG: Mediation Act, Art. 8. HU: Act LV of 2002 on Mediation. (d) Technical testing and analysis services (CPC 8676) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In CY: The provision of services by chemists and biologists requires nationality of a Member State. In FR: The professions of biologist are reserved for natural persons, EEA nationality required. Measures: CY: Registration of Chemists Law of 1988 (Law 157/1988), as amended. FR: Code de la Sant\u00e9 Publique. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Local presence: In BG: Establishment in Bulgaria according to the Bulgarian Commercial Act and registration in the Commercial register is required for provision of technical testing and analysis services. For the periodical inspection for proof of technical condition of road transport vehicles, the person should be registered in accordance with the Bulgarian Commercial Act or the Non-Profit Legal Persons Act, or else be registered in another Member State of the EEA. The testing and analysis of the composition and purity of air and water may be conducted only by the Ministry of Environment and Water of Bulgaria, or its agencies in co-operation with the Bulgarian Academy of Sciences. Measures: BG: Technical Requirements towards Products Act; Measurement Act; Clean Ambient Air Act; and Water Act, Ordinance N-32 for the periodical inspection for proof of technical condition of road transport vehicles. With respect to Investment liberalisation \u2013 National treatment, Most-favoured-nation treatment and Cross-border trade in services \u2013National treatment, Most-favoured-nation treatment, Local presence: In IT: For biologists, chemical analysts, agronomists and \"periti agrari\", residency and enrolment in the professional register are required. Third country nationals can enrol under condition of reciprocity. Measures: IT: Biologists, chemical analysts: Law 396/1967 on the profession of biologists; and Royal Decree 842/1928 on the profession of chemical analysts. (e) Related scientific and technical consulting services (CPC 8675) With respect to Investment liberalisation \u2013 National treatment, Most-favoured nation treatment and Cross-border trade in services \u2013National treatment, Most-favoured-nation treatment, Local presence: In IT: Residency or professional domicile in Italy is required for enrolment in the geologists' register, which is necessary for the practice of the professions of surveyor or geologist in order to provide services relating to the exploration and the operation of mines, etc. Nationality of a Member State is required; however, foreigners may enrol under condition of reciprocity. Measures: IT: Geologists: Law 112/1963, Articles 2 and 5; D.P.R. 1403/1965, Article 1. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 National treatment, Local presence: In BG: For natural persons, nationality and residency of a Member State of the EEA or the Swiss Confederation is required in order to execute functions pertinent to geodesy, cartography and cadastral surveying. For legal entities, trade registration under the legislation of a Member State of the EEA or the Swiss Confederation is required. Measures: BG: Cadastre and Property Register Act; and Geodesy and Cartography Act. With respect to Investment liberalisation \u2013 National Treatment and Cross-border trade in services \u2013 National treatment: In CY: Nationality requirement applies for the provision of relevant services. Measures: CY: Law 224/1990 as amended. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access: In FR: For surveying, access through SEL (anonyme, \u00e0 responsabilit\u00e9 limit\u00e9e ou en commandite par actions), SCP (Soci\u00e9t\u00e9 civile professionnelle), SA and SARL (soci\u00e9t\u00e9s anonymes, \u00e0 responsabilit\u00e9 limit\u00e9e) only. For exploration and prospecting services establishment is required. This requirement may be waived for scientific researchers, by decision of the Minister of scientific research, in agreement with the Minister of Foreign affairs. Measures: FR: Loi 46-942 du 7 mai 1946 and d\u00e9cret n\u00b071-360 du 6 mai 1971. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013National treatment, Local presence: In HR: Services of basic geological, geodetic and mining consulting as well as related environmental protection consulting services in the territory of Croatia can be carried out only jointly with or through domestic legal persons. Measures: HR: Ordinance on requirements for issuing approvals to legal persons for performing professional environmental protection activities (OG No.57/10), Arts. 32-35. (f) Services incidental to agriculture (part of CPC 88) With respect to Investment liberalisation \u2013National treatment and Cross-border trade in services \u2013 National treatment, Most-favoured-nation treatment, Local presence: In IT: For biologists, chemical analysts, agronomists and \"periti agrari\", residency and enrolment in the professional register are required. Third country nationals can enrol under condition of reciprocity. Measures: IT: Biologists, chemical analysts: Law 396/1967 on the profession of biologists; and Royal Decree 842/1928 on the profession of chemical analysts. With respect to Investment liberalisation \u2013 Market access, Most-favoured-nation treatment and Cross-border trade in services \u2013 Market access, Most-favoured-nation treatment: In PT: The professions of biologist, chemical analyst and agronomist are reserved for natural persons. For third-country nationals, reciprocity regime applies in the case of engineers and technical engineers (and not a citizenship requirement). For biologists, there is not a citizenship requirement nor a reciprocity requirement. Measures: PT: Decree Law 119/92 alterado p/ Lei 123/2015, 2 set. (Ordem Engenheiros); Law 47/2011 alterado p/ Lei 157/2015, 17 set. (Ordem dos Engenheiros T\u00e9cnicos); and Decree Law 183/98 alterado p/ Lei 159/2015, 18 set. (Ordem dos Bi\u00f3logos). (g) Security Services (CPC 87302, 87303, 87304, 87305, 87309) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In IT: Nationality of a Member State of the European Union and residency is required in order to obtain the necessary authorisation to supply security guard services and the transport of valuables. In PT: The provision of security services by a foreign supplier on a cross-border basis is not allowed. A nationality requirement exists for specialised personnel. Measures: IT: Law on public security (TULPS) 773/1931, Articles 133-141; Royal Decree 635/1940, Article 257. PT: Law 34/2013 alterada p/ Lei 46/2019, 16 maio; and Ordinance 273/2013 alterada p/ Portaria 106/2015, 13 abril. With respect to Investment liberalisation \u2013 National treatment, Most-Favoured Nation treatment and Cross-border trade in services \u2013 Local presence: In DK: Residence requirement for individuals applying for an authorisation to provide security services. Residence is also required for managers and the majority of members of the board of a legal entity applying for an authorisation to conduct security services. However, residence for management and boards of directors is not required to the extent it follows from international agreements or orders issued by the Minister for Justice. Measures: DK: Lovbekendtg\u00f8relse 2016-01-11 nr. 112 om vagtvirksomhed. With respect to Cross-border trade in services \u2013 Local presence: In EE: Residency is required for security guards. Measures: EE: Turvaseadus (Security Act) \u00a7 21, \u00a7 22. (h) Placement Services (CPC 87201, 87202, 87203, 87204, 87205, 87206, 87209) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment (applies to the regional level of government): In BE: In all Regions in Belgium, a company having its head office outside the EEA has to demonstrate that it supplies placement services in its country of origin. In the Walloon Region, a specific type of legal entity (r\u00e9guli\u00e8rement constitu\u00e9e sous la forme d'une personne morale ayant une forme commerciale, soit au sens du droit belge, soit en vertu du droit d'un Etat membre ou r\u00e9gie par celui-ci, quelle que soit sa forme juridique) is required to supply placement services. A company having its head office outside the EEA has to demonstrate that it fulfils the conditions as set out in the Decree (for instance on the type of legal entity). In the German-speaking community, a company having its head office outside the EEA has to fulfil the admission criteria established by the mentioned Decree (CPC 87202). Measures: BE: Flemish Region: Article 8, \u00a7 3, Besluit van de Vlaamse Regering van 10 december 2010 tot uitvoering van het decreet betreffende de private arbeidsbemiddeling. Walloon Region: D\u00e9cret du 3 avril 2009 relatif \u00e0 l'enregistrement ou \u00e0 l'agr\u00e9ment des agences de placement (Decree of 3 April 2009 on registration of placement agencies), Article 7; and Arr\u00eat\u00e9 du Gouvernement wallon du 10 d\u00e9cembre 2009 portant ex\u00e9cution du d\u00e9cret du 3 avril 2009 relatif \u00e0 l'enregistrement ou \u00e0 l'agr\u00e9ment des agences de placement (Decision of the Walloon Government of 10 December 2009 implementing the Decree of 3 April 2009 on registration of placement agencies), Article 4. German-speaking community: Dekret \u00fcber die Zulassung der Leiharbeitsvermittler und die \u00dcberwachung der privaten Arbeitsvermittler / D\u00e9cret du 11 mai 2009 relatif \u00e0 l'agr\u00e9ment des agences de travail int\u00e9rimaire et \u00e0 la surveillance des agences de placement priv\u00e9es, Article 6. With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013National treatment, Local presence: In DE: Nationality of a Member State of the European Union or a commercial presence in the European Union is required in order to obtain a licence to operate as a temporary employment agency pursuant to Sec. 3 paragraphs 3 to 5 of this Act on temporary agency work (Arbeitnehmer\u00fcberlassungsgesetz). The Federal Ministry of Labour and Social Affairs may issue a regulation concerning the placement and recruitment of non-EEA personnel for specified professions e.g. for health and care related professions. The licence or its extension shall be refused if establishments, parts of establishments or ancillary establishments which are not located in the EEA are intended to execute the temporary employment pursuant to Sec. 3 paragraph 2 of the Act on temporary agency work (Arbeitnehmer\u00fcberlassungsgesetz). Measures: DE: Gesetz zur Regelung der Arbeitnehmer\u00fcberlassung (A\u00dcG); Sozialgesetzbuch Drittes Buch (SGB III; Social Code, Book Three) - Employment Promotion; Verordnung \u00fcber die Besch\u00e4ftigung von Ausl\u00e4nderinnen und Ausl\u00e4ndern (BeschV; Ordinance on the Employment of Foreigners). With respect to Investment liberalisation \u2013 Market access: In ES: Prior to the start of the activity, placement agencies are required to submit a sworn statement certifying the fulfilment of the requirements stated by the current legislation (CPC 87201, 87202). Measures: ES: Real Decreto-ley 8/2014, de 4 de julio, de aprobaci\u00f3n de medidas urgentes para el crecimiento, la competitividad y la eficiencia (tramitado como Ley 18/2014, de 15 de octubre). (i) Translation and interpretation services (CPC 87905) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access: In BG: To carry out official translation activities foreign natural persons are required to hold a permit for long-term or permanent residency in the Republic of Bulgaria. Measures: BG: Regulation for the legalisation, certification and translation of documents. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access: In HU: Official translations, official certifications of translations, and certified copies of official documents in foreign languages may only be provided by the Hungarian Office for Translation and Attestation (OFFI). In PL: Only natural persons may be sworn translators. Measures: HU: Decree of the Council of Ministers No. 24/1986 on Official translation and interpretation. PL: Act of 25 November 2004 on the profession of sworn translator or interpreter (Journal of Laws from 2019 item 1326). With respect to Cross-border trade in services \u2013Market Access: In FI: Residency in the EEA is required for certified translators. Measures: FI: Laki auktorisoiduista k\u00e4\u00e4nt\u00e4jist\u00e4 (Act on Authorised Translators) (1231/2007), s. 2(1). With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 National treatment: In CY: Registration to registry of translators is necessary for the provision of official translation and certification services. Nationality requirement applies. In HR: EEA nationality is required for certified translators. Measures: CY: The Establishment, Registration and Regulation of the Certified Translator Services in the Republic of Cyprus Law. HR: Ordinance on permanent court interpreters (OG 88/2008), Article 2. (j) Other business services (part of CPC 612, part of 621, part of 625, 87901, 87902, 88493, part of 893, part of 85990, 87909, ISIC 37) With respect to Investment liberalisation \u2013 Market access: In SE: Pawn-shops must be established as a limited liability company or as a branch (part of CPC 87909). With respect to Investment liberalisation \u2013 Market access, and Cross-border trade in services \u2013 Local presence: In CZ: Only an authorised package company is allowed to supply services relating to packaging take-back and recovery and must be a legal person established as a joint-stock company (CPC 88493, ISIC 37). With respect to Investment liberalisation \u2013 Market access, and Cross-border trade in services \u2013 Market access: In NL: To provide hallmarking services, commercial presence in the Netherlands is required. The hallmarking of precious metal Articles is currently exclusively granted to two Dutch public monopolies (part of CPC 893). Measures: CZ: Act. 477/2001 Coll. (Packaging Act) paragraph 16. SE: Pawn shop act (1995:1000). NL: Waarborgwet 1986. With respect to Investment liberalisation \u2013 Market Access, National Treatment: In PT: Nationality of a Member State is required for the provision of collection agency services and credit reporting services (CPC 87901, 87902). Measures: PT: Law 49/2004. With respect to Investment liberalisation \u2013 Market access, National Treatment and Cross-border trade in services \u2013 Local presence: In CZ: Auction services are subject to licence. To obtain a licence (for the supply of voluntary public auctions), a company must be incorporated in the Czech Republic and a natural person is required to obtain a residency permit, and the company, or natural person must be registered in the Commercial Register of the Czech Republic (part of CPC 612, part of 621, part of 625, part of 85990). Measures: CZ: Act no.455/1991 Coll.; Trade Licence Act; and Act no. 26/2000 Coll., on public auctions. With respect to Cross-border trade in services \u2013Market access: In SE: The economic plan for a building society must be certified by two persons. These persons must be publicly approved by authorities in the EEA (CPC 87909). Measures: SE: Cooperative building societies law (1991:614). Reservation No. 7 - Communication services Sector \u2013 sub-sector: Communication services - postal and courier services Industry classification: Part of CPC 71235, part of 73210, part of 751 Type of reservation: Market access Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation - Market access and Cross-border trade in services - Market access: The EU: The organisation of the siting of letter boxes on the public highway, the issuing of postage stamps and the provision of the registered mail service used in the course of judicial or administrative procedures may be restricted in accordance with national legislation. Licensing systems may be established for those services for which a general universal service obligation exists. These licences may be subject to particular universal service obligations or a financial contribution to a compensation fund. Measures: EU: Directive 97/67/EC of the European Parliament and of the Council (8). Reservation No. 8 - Construction Services Sector \u2013 sub-sector: Construction and related engineering services Industry classification: CPC 51 Type of reservation: National treatment Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: In CY: Nationality requirement. Measure: The Registration and Control of Contractors of Building and Technical Works Law of 2001 (29 (I) / 2001), Articles 15 and 52. Reservation No. 9 - Distribution services Sector \u2013 sub-sector: Distribution services \u2013 general, distribution of tobacco Industry classification: CPC 3546, part of 621, 6222, 631, part of 632 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation; Cross-Border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Distribution services (CPC 3546, 631, 632 except 63211, 63297, 62276, part of 621) With respect to Investment liberalisation \u2013 Market access: In PT: A specific authorisation scheme exists for the installation of certain retail establishments and shopping centres. This relates to shopping centres that have a gross leasable area equal or greater than 8,000 m2, and retail establishments having a sales area equal or exceeding 2,000 m2, when located outside shopping centres. Main criteria: Contribution to a multiplicity of commercial offers; assessment of services to consumer; quality of employment and corporate social responsibility; integration in urban environment; contribution to eco-efficiency (CPC 631, 632 except 63211, 63297). Measures: PT: Decree-Law No. 10/2015, 16 January. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In CY: Nationality requirement exists for distribution services provided by pharmaceutical representatives (CPC 62117). Measures: CY: Law 74(I) 2020 as amended. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Local presence: In LT: The distribution of pyrotechnics is subject to licensing. Only legal persons of the Union may obtain a licence (CPC 3546). Measures: LT: Law on Supervision of Civil Pyrotechnics Circulation (23 March 2004. No. IX-2074). (b) Distribution of tobacco (part of CPC 6222, 62228, part of 6310, 63108) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In ES: There is a state monopoly on retail sales of tobacco. Establishment is subject to a Member State nationality requirement. Only natural persons may operate as a tobacconist. Each tobacconist cannot obtain more than one license (CPC 63108). In FR: State monopoly on wholesale and retail sales of tobacco. Nationality requirement for tobacconists (buraliste) (part of CPC 6222, part of 6310). Measures: ES: Law 14/2013 of 27 September 2014. FR: Code g\u00e9n\u00e9ral des imp\u00f4ts. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In AT: Only natural persons may apply for an authorisation to operate as a tobacconist. Priority is given to nationals of a Member State of the EEA (CPC 63108). Measures: AT: Tobacco Monopoly Act 1996, \u00a7 5 and \u00a7 27. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access, National treatment: In IT: In order to distribute and sell tobacco, a licence is needed. The licence is granted through public procedures. The granting of licences is subject to an economic needs test. Main criteria: population and geographical density of existing selling points (part of CPC 6222, part of 6310). Measures: IT: Legislative Decree 184/2003; Law 165/1962; Law 3/2003; Law 1293/1957; Law 907/1942; and Decree of the President of the Republic (D.P.R.) 1074/1958. Reservation No. 10 - Education services Sector \u2013 sub-sector: Education services (privately funded) Industry classification: CPC 921, 922, 923, 924 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access: In CY: Nationality of a Member State is required for owners and majority shareholders in a privately funded school. Nationals of the United Kingdom may obtain authorisation from the Minister (of Education) in accordance with the specified form and conditions. Measures: CY: Private Schools Law of 2019 (N. 147(I)/2019) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In BG: Privately funded primary and secondary education services may only be supplied by authorised Bulgarian enterprises (commercial presence is required). Bulgarian kindergartens and schools having foreign participation may be established or transformed at the request of associations, or corporations, or enterprises of Bulgarian and foreign natural or legal entities, duly registered in Bulgaria, by decision of the Council of Ministers on a motion by the Minister of Education and Science. Foreign owned kindergartens and schools may be established or transformed at the request of foreign legal entities in accordance with international agreements and conventions and under the provisions above. Foreign higher education institutions cannot establish subsidiaries in the territory of Bulgaria. Foreign higher education institutions may open faculties, departments, institutes and colleges in Bulgaria only within the structure of Bulgarian high schools and in cooperation with them (CPC 921, 922). Measures: BG: Pre-school and School Education Act; and Law for the Higher Education, paragraph 4 of the additional provisions. With respect to Investment liberalisation \u2013 Market access, National treatment In SI: Privately funded elementary schools may be founded by Slovenian natural or legal persons only. The service supplier must establish a registered office or branch office (CPC 921). Measures: SI: Organisation and Financing of Education Act (Official Gazette of Republic of Slovenia, no. 12/1996) and its revisions, Article 40. With respect to Cross-border services \u2013 Local presence: In CZ and SK: Establishment in a Member State is required to apply for state approval to operate as a privately funded higher education institution. This reservation does not apply to post-secondary technical and vocational education services (CPC 92310). Measures: CZ: Act No. 111/1998, Coll. (Higher Education Act), \u00a7 39; and Act No. 561/2004 Coll. on Pre-school, Basic, Secondary, Tertiary Professional and Other Education (the Education Act). SK: Law No. 131/2002 on Universities. With respect to Investment liberalisation \u2013 Market access and Cross-border services: Market access: In ES and IT: An authorisation is required in order to open a privately funded university which issues recognised diplomas or degrees. An economic needs test is applied. Main criteria: population and density of existing establishments. In ES: The procedure involves obtaining the advice of the Parliament. In IT: This is based on a three-year programme and only Italian legal persons may be authorised to issue state-recognised diplomas (CPC 923). Measures: ES: Ley Org\u00e1nica 6/2001, de 21 de Diciembre, de Universidades (Law 6 / 2001 of 21 December, on Universities), Article 4. IT: Royal Decree 1592/1933 (Law on secondary education); Law 243/1991 (Occasional public contribution for private universities); Resolution 20/2003 of CNVSU (Comitato nazionale per la valutazione del sistema universitario); and Decree of the President of the Republic (DPR) 25/1998. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access: In EL: Nationality of a Member State is required for owners and a majority of the members of the board of directors in privately funded primary and secondary schools, and for teachers in privately funded primary and secondary education (CPC 921, 922). Education at university level shall be provided exclusively by institutions which are fully self-governed public law legal persons. However, Law 3696/2008 permits the establishment by Union residents (natural or legal persons) of private tertiary education institutions granting certificates which are not recognised as being equivalent to university degrees (CPC 923). Measures: EL: Laws 682/1977, 284/1968, 2545/1940, Presidential Degree 211/1994 as amended by Presidential Degree 394/1997, Constitution of Hellas, Article 16, paragraph 5 and Law 3549/2007. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access: In AT: The provision of privately funded university level education services in the area of applied sciences requires an authorisation from the competent authority, the AQ Austria (Agency for Quality Assurance and Accreditation Austria). An investor seeking to provide such services must have his primary business being the supply of such services, and must submit a needs assessment and a market survey for the acceptance of the proposed study programme. The competent Ministry may deny the approval if the decision of the accreditation authority does not comply with national educational interests. The applicant for a private university requires an authorisation from the competent authority (AQ Austria - Agency for Quality Assurance and Accreditation Austria). The competent Ministry may deny the approval if the decision of the accreditation authority does not comply with national educational interests (CPC 923). Measures: AT: University of Applied Sciences Studies Act, BGBl. I Nr. 340/1993 as amended, \u00a7 2, 8; Private Higher Education Institution Act, BGBl. I Nr. 77/2020, \u00a7 2; and Act on Quality Assurance in Higher Education, BGBl. Nr. 74/2011 as amended, \u00a7 25 (3). With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services \u2013 Market access, National treatment: In FR: Nationality of a Member State is required in order to teach in a privately funded educational institution (CPC 921, 922, 923). However, nationals of the United Kingdom may obtain an authorisation from the relevant competent authorities in order to teach in primary, secondary and higher level educational institutions. Nationals of the United Kingdom may also obtain an authorisation from the relevant competent authorities in order to establish and operate or manage primary, secondary or higher level educational institutions. Such authorisation is granted on a discretionary basis. Measures: FR: Code de l'\u00e9ducation. With respect to Investment \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In MT: Service suppliers seeking to provide privately funded higher or adult education services must obtain a licence from the Ministry of Education and Employment. The decision on whether to issue a licence may be discretionary (CPC 923, 924). Measures: MT: Legal Notice 296 of 2012. Reservation No. 11 - Environmental services Sector \u2013 sub-sector: Environmental services \u2013 processing and recycling of used batteries and accumulators, old cars and waste from electrical and electronic equipment; protection of ambient air and climate cleaning services of exhaust gases Industry classification: Part of CPC 9402, 9404 Type of reservation: Local presence Chapter: Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: In SE: Only entities established in Sweden or having their principal seat in Sweden are eligible for accreditation to perform control services of exhaust gas (CPC 9404). In SK: For processing and recycling of used batteries and accumulators, waste oils, old cars and waste from electrical and electronic equipment, incorporation in the EEA is required (residency requirement) (part of CPC 9402). Measures: SE: The Vehicles Act (2002:574). SK: Act 79/2015 on Waste. Reservation No. 12 \u2013 Financial Services Sector \u2013 sub-sector: Financial services \u2013 insurance and banking Industry classification: Not applicable Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Insurance and Insurance-related Services With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In IT: Access to the actuarial profession through natural persons only. Professional associations (no incorporation) among natural persons permitted. European Union nationality is required for the practice of the actuarial profession, except for foreign professionals who may be allowed to practice based on reciprocity. Measures: IT: Article 29 of the code of private insurance (Legislative decree no. 209 of 7 September 2005); and Law 194/1942, Article 4, Law 4/1999 on the register. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Local presence: In BG: Pension insurance shall be carried out as a joint-stock company licensed in accordance with the Code of Social Insurance and registered under the Commerce Act or under the legislation of another Member State of the EU (no branches). In BG, ES, PL and PT: Direct branching is not permitted for insurance intermediation, which is reserved to companies formed in accordance with the law of a Member State (local incorporation is required). For PL, residency requirement for insurance intermediaries. Measures: BG: Insurance Code, articles 12, 56-63, 65, 66 and 80 paragraph 4, Social Insurance Code Art. 120a\u2013162, Art. 209\u2013253, Art. 260\u2013310. ES: Reglamento de Ordenaci\u00f3n, Supervisi\u00f3n y Solvencia de Entidades Aseguradoras y Reaseguradoras (RD 1060/2015, de 20 de noviembre de 2015), article 36. PL: Act on insurance and reinsurance activity of September 11, 2015 (Journal of Laws of 2020, item 895 and 1180); Act on insurance distribution of December 15, 2017 (Journal of Laws 2019, item 1881); Act on the organization and operation of pension funds of August 28, 1997 (Journal of Laws of 2020, item 105); Act of 6 March 2018 on rules regarding economic activity of foreign entrepreneurs and other foreign persons in the territory of the Republic of Poland. PT: Article 7 of Decree-Law 94-B/98 revoked by Decree-Law 2/2009, January 5th; and chapter I, Section VI of Decree-Law 94-B/98, articles 34, nr. 6, 7, and article 7 of Decree-Law 144/2006, revoked by Law 7/2019, January 16th. Article 8 of the legal regime governing the business of insurance and reinsurance distribution, approved by Law 7/2019, of January 16th. With respect to Investment liberalisation \u2013 National treatment: In AT: The management of a branch office must consist of at least two natural persons resident in AT. In BG: Residency requirement for the members of managing and supervisory body of (re)insurance undertakings and every person authorised to manage or represent the (re)insurance undertaking. The Chairperson of the Management Board, the Chairperson of the Board of Directors, the Executive Director and the Managerial Agent of pension insurance companies must have a permanent address or hold a durable residence permit in Bulgaria. Measures: AT: Insurance Supervision Act 2016, Article 14 para. 1 no. 3, Federal Law Gazette I No. 34/2015 (Versicherungsaufsichtsgesetz 2016, \u00a7 14 Abs. 1 Z 3, BGBl. I Nr. 34/2015) BG: Insurance Code, articles 12, 56-63, 65, 66 and 80 paragraph 4, Social Insurance Code, Art. 120a\u2013162, Art. 209\u2013253, Art. 260\u2013310 With respect to Investment liberalisation \u2013 Market access, National treatment: In BG: Before establishing a branch or agency to provide insurance, a foreign insurer or reinsurer must have been authorised to operate in its country of origin in the same classes of insurance as those it wishes to provide in BG. The income of the supplementary voluntary pension funds, as well as similar income directly connected with voluntary pension insurance, carried out by persons who are registered under the legislation of another Member State and who may, in compliance with the legislation concerned, perform voluntary pension insurance operations, shall not be taxable according to the procedure established by the Corporate Income Tax Act. In ES: Before establishing a branch or agency in Spain in order to provide certain classes of insurance, a foreign insurer must have been authorised to operate in the same classes of insurance in its country of origin for at least five years. In PT: In order to establish a branch or agency, foreign insurance undertakings must have been authorised to carry out the business of insurance or reinsurance, according to the relevant national law for at least five years. Measures: BG: Insurance Code, articles 12, 56-63, 65, 66 and 80 paragraph 4, Social Insurance Code, Art. 120a\u2013162, Art. 209\u2013253, Art. 260\u2013310. ES: Reglamento de Ordenaci\u00f3n, Supervisi\u00f3n y Solvencia de Entidades Aseguradoras y Reaseguradoras (RD 1060/2015, de 20 de noviembre de 2015), article 36. PT: Article 7 of Decree-Law 94-B/98 and chapter I, Section VI of Decree-Law 94-B/98, articles 34, nr. 6, 7, and article 7 of Decree-Law 144/2006; Article 215 of legal regime governing the taking up and pursuit of the business of insurance and reinsurance, approved by Law 147/2005, of September 9th. With respect to Investment liberalisation \u2013 Market access: In AT: In order to obtain a licence to open a branch office, foreign insurers must have a legal form corresponding or comparable to a joint stock company or a mutual insurance association in their home country. In EL: Insurance and reinsurance undertakings with head offices in third countries may operate in Greece via establishing a subsidiary or a branch, where branch in this case does not take any specific legal form, as it means a permanent presence in the territory of a Member State (i.e. Greece) of an undertaking with head office outside EU, which receives authorisation in that Member State (Greece) and which pursues insurance business. Measures: AT: Insurance Supervision Act 2016, Article 14 para. 1 no. 1, Federal Law Gazette I No. 34/2015 (Versicherungsaufsichtsgesetz 2016, \u00a7 14 Abs. 1 Z 1, BGBl. I Nr. 34/2015). EL: Art. 130 of the Law 4364/ 2016 (Gov. Gazette 13/ A/ 05.02.2016). With respect to Cross-border trade in services \u2013 National treatment, Local presence: In AT: Promotional activity and intermediation on behalf of a subsidiary not established in the Union or of a branch not established in AT (except for reinsurance and retrocession) are prohibited. In DK: No persons or companies (including insurance companies) may, for business purposes, assist in effecting direct insurance for persons resident in DK, for Danish ships or for property in DK, other than insurance companies licensed by Danish law or by Danish competent authorities. In SE: The supply of direct insurance by a foreign insurer is allowed only through the mediation of an insurance service supplier authorised in Sweden, provided that the foreign insurer and the Swedish insurance company belong to the same group of companies or have an agreement of cooperation between them. With respect to Cross-border trade in services \u2013 Local presence: In DE, HU and LT: The supply of direct insurance services by insurance companies not incorporated in the European Union requires the setting up and authorisation of a branch. In SE: The provision of insurance intermediation services by undertakings not incorporated in the EEA requires the establishment of a commercial presence (local presence requirement). In SK: Air and maritime transport insurance, covering the aircraft/vessel and responsibility, can be underwritten only by insurance companies established in the Union or by the branch office of the insurance companies not established in the Union authorised in the Slovak Republic. Measures AT: Insurance Supervision Act 2016, Article 13 para. 1 and 2, Federal Law Gazette I No. 34/2015 (Versicherungsaufsichtsgesetz 2016, \u00a7 13 Abs. 1 und 2, BGBl. I Nr. 34/2015) DE: Versicherungsaufsichtsgesetz (VAG) for all insurance services; in connection with Luftverkehrs-Zulassungs-Ordnung (LuftVZO) only for compulsory air liability insurance. DK: Lov om finansiel virksomhed jf. lovbekendtg\u00f8relse 182 af 18. februar 2015. HU: Act LX of 2003. LT: Law on Insurance, 18 of September, 2003 m. Nr. IX-1737, last amendment 13 of June 2019 Nr. XIII-2232. SE: Lag om f\u00f6rs\u00e4kringsf\u00f6rmedling (Insurance Distribution Mediation Act) (Chapter 3, section 3, 2018:12192005:405); and Foreign Insurers Business in Sweden Act (Chapter 4, section 1 and 10, 1998:293). SK: Act 39/2015 on insurance. (b) Banking and other financial services With respect to Investment liberalisation \u2013 Market Access, National treatment, and Cross-border trade in services \u2013 Local presence: In BG: For pursuing the activities of lending with funds which are not raised through taking of deposits or other repayable funds, acquiring holdings in a credit institution or another financial institution, financial leasing, guarantee transactions, acquisition of claims on loans and other forms of financing (factoring, forfeiting, etc.), non-bank financial institutions are subject to registration regime with the Bulgarian National Bank. The financial institution shall have its main business in the territory of Bulgaria. In BG: Non-EEA banks may pursue banking activity in Bulgaria after obtaining a license from BNB for taking up and pursuing of business activities in the Republic of Bulgaria through a branch. In IT: In order to be authorised to operate the securities settlement system or to provide central securities depository services with an establishment in Italy, a company is required to be incorporated in Italy (no branches). In the case of collective investment schemes other than undertakings for collective investment in transferable securities (\"UCITS\") harmonised under Union legislation, the trustee or depository is required to be established in Italy or in another Member State and have a branch in Italy. Management enterprises of investment funds not harmonised under Union legislation are also required to be incorporated in Italy (no branches). Only banks, insurance enterprises, investment firms and enterprises managing UCITS harmonised under Union legislation having their legal head office in the Union, as well as UCITS incorporated in Italy, may carry out the activity of pension fund resource management. In providing the activity of door-to-door selling, intermediaries must utilise authorised financial salesmen resident within the territory of a Member State. Representative offices of non-European Union intermediaries cannot carry out activities aimed at providing investment services, including trading for own account and for the account of customers, placement and underwriting financial instruments (branch required). In PT: Pension fund management may be provided only by specialised companies incorporated in PT for that purpose and by insurance companies established in PT and authorised to take up life insurance business, or by entities authorised to provide pension fund management in other Member States. Direct branching from non-European Union countries is not permitted. Measures: BG: Law on Credit Institutions, article 2, paragraph 5, article 3a and article 17 Code of Social Insurance, articles 121, 121b, 121f; and Currency Law, article 3. IT: Legislative Decree 58/1998, articles 1, 19, 28, 30-33, 38, 69 and 80; Joint Regulation of Bank of Italy and Consob 22.2.1998, articles 3 and 41; Regulation of Bank of Italy 25.1.2005; Title V, Chapter VII, Section II, Consob Regulation 16190 of 29.10.2007, articles 17-21, 78-81, 91-111; and subject to: Regulation (EU) No 909/2014 of the European Parliament and of the Council (9). PT: Decree-Law 12/2006, as amended by Decree-Law 180/2007 Decree-Law 357-A/2007, Regulation 7/2007-R, as amended by Regulation 2/2008-R, Regulation 19/2008-R, Regulation 8/2009. Article 3 of the legal regime governing the establishment and functioning of pension funds and their management entities approved by Law 27/2020, of July 23rd. With respect to Investment liberalisation \u2013 Market access, National treatment: In HU: Branches of non-EEA investment fund management companies may not engage in the management of European investment funds and may not provide asset management services to private pension funds. Measures: HU: Act CCXXXVII of 2013 on Credit Institutions and Financial Enterprises; and Act CXX of 2001 on the Capital Market. With respect to Investment liberalisation \u2013 National Treatment and Cross-border trade in services \u2013 Market access: In BG: \u0410 bank shall be managed and represented jointly by at least two persons. The persons who manage and represent the bank shall be personally present at its management address. Legal persons may not be elected members of the managing board or the board of directors of a bank. In SE: A founder of a savings bank shall be a natural person. Measures: BG: Law on Credit Institutions, article 10; Code Of Social Insurance, article 121e; and Currency Law, article 3. SE: Sparbankslagen (Savings Bank Act) (1987:619), Chapter 2, \u00a7 1. With respect to Investment liberalisation \u2013 National treatment: In HU: The board of directors of a credit institution shall have at least two members recognised as resident according to foreign exchange regulations and having had prior permanent residence in HU for at least one year. Measures: HU: Act CCXXXVII of 2013 on Credit Institutions and Financial Enterprises; and Act CXX of 2001 on the Capital Market. With respect to Investment liberalisation \u2013 Market access: In RO: Market operators are legal persons set up as joint stock companies according to the provisions of the Company law. Alternative trading systems (Multilateral trading facility (MTF) pursuant to MiFID II Directive) can be managed by a system operator set up under the conditions described above or by an investment firm authorised by ASF (Autoritatea de Supraveghere Financiar\u0103 \u2013 Financial Supervisory Authority). In SI: A pension scheme may be provided by a mutual pension fund (which is not a legal entity and is therefore managed by an insurance company, a bank or a pension company), a pension company or an insurance company. Additionally, a pension scheme can also be offered by pension scheme providers established in accordance with the regulations applicable in a Member State of the EU. Measures: RO: Law no. 126 of 11 June 2018 regarding financial instruments and Regulation no. 1/2017 for the amendment and supplement of Regulation no. 2/2006 on regulated markets and alternative trading systems, approved by Order of NSC no. 15/2006 - ASF \u2013 Autoritatea de Supraveghere Financiar\u0103 \u2013 Financial Supervisory Authority. SI: Pension and Disability Insurance Act, (Official Gazette no. 102/2015 (as last amended No 28/19). With respect to Cross-border trade in services \u2013 Local presence: In HU: Non-EEA companies may provide financial services or engage in activities auxiliary to financial services solely through a branch in HU. Measures: HU: Act CCXXXVII of 2013 on Credit Institutions and Financial Enterprises; and Act CXX of 2001 on the Capital Market. Reservation No. 13 - Health services and social services Sector \u2013 sub-sector: Health services and social services Industry classification: CPC 931, 933 Type of reservation: Market access National treatment Chapter: Investment liberalisation and Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation \u2013 Market access: In DE: (applies also to the regional level of government): Rescue services and \"qualified ambulance services\" are organised and regulated by the L\u00e4nder. Most L\u00e4nder delegate competences in the field of rescue services to municipalities. Municipalities are allowed to give priority to not-for-profit operators. This applies equally to foreign as well as domestic service suppliers (CPC 931, 933). Ambulance services are subject to planning, permission and accreditation. Regarding telemedicine, the number of ICT (information and communications technology) service suppliers may be limited to guarantee interoperability, compatibility and necessary safety standards. This is applied in a non-discriminatory way. In HR: Establishment of some privately funded social care facilities may be subject to needs based limits in particular geographical areas (CPC 9311, 93192, 93193, 933). In SI: a state monopoly is reserved for the following services: Supply of blood, blood preparations, removal and preservation of human organs for transplant, socio-medical, hygiene, epidemiological and health-ecological services, patho-anatomical services, and biomedically-assisted procreation (CPC 931). Measures: DE: Bundes\u00e4rzteordnung (B\u00c4O; Federal Medical Regulation): Gesetz \u00fcber die Aus\u00fcbung der Zahnheilkunde (ZHG); Gesetz \u00fcber den Beruf der Psychotherapeutin und des Psychotherapeuten (PsychThG; Act on the Provision of Psychotherapy Services); Gesetz \u00fcber die berufsm\u00e4\u00dfige Aus\u00fcbung der Heilkunde ohne Bestallung (Heilpraktikergesetz); Gesetz \u00fcber das Studium und den Beruf der Hebammen (HebG); Gesetz \u00fcber den Beruf der Notfallsanit\u00e4terin und des Notfallsanit\u00e4ters (NotSanG); Gesetz \u00fcber die Pflegeberufe (PflBG); Gesetz \u00fcber die Berufe in der Physiotherapie (MPhG); Gesetz \u00fcber den Beruf des Logop\u00e4den (LogopG); Gesetz \u00fcber den Beruf des Orthoptisten und der Orthoptistin (OrthoptG); Gesetz \u00fcber den Beruf der Podologin und des Podologen (PodG); Gesetz \u00fcber den Beruf der Di\u00e4tassistentin und des Di\u00e4tassistenten (Di\u00e4tAssG); Gesetz \u00fcber den Beruf der Ergotherapeutin und des Ergotherapeuten (ErgThg); Bundesapothekerordnung (BapO); Gesetz \u00fcber den Beruf des pharmazeutisch-technischen Assistenten (PTAG); Gesetz \u00fcber technische Assistenten in der Medizin (MTAG); Gesetz zur wirtschaftlichen Sicherung der Krankenh\u00e4user und zur Regelung der Krankenhauspfleges\u00e4tze (Krankenhausfinanzierungsgesetz - KHG); Gewerbeordnung (German Trade, Commerce and Industry Regulation Act); Sozialgesetzbuch F\u00fcnftes Buch (SGB V; Social Code, Book Five) - Statutory Health Insurance; Sozialgesetzbuch Sechstes Buch (SGB VI; Social Code, Book Six) - Statutory Pension Insurance; Sozialgesetzbuch Siebtes Buch (SGB VII; Social Code, Book Seven) - Statutory Accident Insurance; Sozialgesetzbuch Neuntes Buch (SGB IX; Social Code, Book Nine) - Rehabilitation and Participation of Persons with Disabilities; Sozialgesetzbuch Elftes Buch (SGB XI; Social Code, Book Eleven) - Social Assistance. Personenbef\u00f6rderungsgesetz (PBefG; Act on Public Transport). Regional level: Gesetz \u00fcber den Rettungsdienst (Rettungsdienstgesetz - RDG) in Baden-W\u00fcrttemberg; Bayerisches Rettungsdienstgesetz (BayRDG); Gesetz \u00fcber den Rettungsdienst f\u00fcr das Land Berlin (Rettungsdienstgesetz); Gesetz \u00fcber den Rettungsdienst im Land Brandenburg (BbgRettG); Bremisches Hilfeleistungsgesetz (BremHilfeG); Hamburgisches Rettungsdienstgesetz (HmbRDG); Gesetz \u00fcber den Rettungsdienst f\u00fcr das Land Mecklenburg-Vorpommern (RDGM-V); Nieders\u00e4chsisches Rettungsdienstgesetz (NRettDG); Gesetz \u00fcber den Rettungsdienst sowie die Notfallrettung und den Krankentransport durch Unternehmer (RettG NRW); Landesgesetz \u00fcber den Rettungsdienst sowie den Notfall- und Krankentransport (RettDG); Saarl\u00e4ndisches Rettungsdienstgesetz (SRettG); S\u00e4chsisches Gesetz \u00fcber den Brandschutz, Rettungsdienst und Katastrophenschutz (S\u00e4chsBRKG); Rettungsdienstgesetz des Landes Sachsen-Anhalt (RettDG LSA); Schleswig-Holsteinisches Rettungsdienstgesetz (SHRDG); Th\u00fcringer Rettungsdienstgesetz (Th\u00fcRettG). Landespflegegesetze: Gesetz zur Umsetzung der Pflegeversicherung in Baden-W\u00fcrttemberg (Landespflegegesetz - LPflG); Gesetz zur Ausf\u00fchrung der Sozialgesetze (AGSG); Gesetz zur Planung und Finanzierung von Pflegeeinrichtungen (Landespflegeeinrichtungsgesetz- LPflegEG); Gesetz \u00fcber die pflegerische Versorgung im Land Brandenburg (Landespflegegesetz - LPflegeG); Gesetz zur Ausf\u00fchrung des Pflege-Versicherungsgesetzes im Lande Bremen und zur \u00c4nderung des Bremischen Ausf\u00fchrungsgesetzes zum Bundessozialhilfegesetz (BremAGPflegeVG); Hamburgisches Landespflegegesetz (HmbLPG); Hessisches Ausf\u00fchrungsgesetz zum Pflege-Versicherungsgesetz; Landespflegegesetz (LPflegeG M-V); Gesetz zur Planung und F\u00f6rderung von Pflegeeinrichtungen nach dem Elften Buch Sozialgesetzbuch (Nieders\u00e4chsisches Pflegegesetz - NPflegeG); Gesetz zur Weiterentwicklung des Landespflegerechts und Sicherung einer unterst\u00fctzenden Infrastruktur f\u00fcr \u00e4ltere Menschen, pflegebed\u00fcrftige Menschen und deren Angeh\u00f6rige (Alten- und Pflegegesetz Nordrhein-Westfalen \u2013 APG NRW); Landesgesetz zur Sicherstellung und Weiterentwicklung der pflegerischen Angebotsstruktur (LPflegeASG) (Rheinland-Pfalz); Gesetz Nr. 1694 zur Planung und F\u00f6rderung von Angeboten f\u00fcr hilfe-, betreuungs- oder pflegebed\u00fcrftige Menschen im Saarland (Saarl\u00e4ndisches Pflegegesetz); S\u00e4chsisches Pflegegesetz (S\u00e4chsPflegeG); Schleswig-Holstein: Ausf\u00fchrungsgesetz zum Pflege-Versicherungsgesetz (Landespflegegesetz - LPflegeG); Th\u00fcringer Gesetz zur Ausf\u00fchrung des Pflege-Versicherungsgesetzes (Th\u00fcrAGPflegeVG). Landeskrankenhausgesetz Baden-W\u00fcrttemberg; Bayerisches Krankenhausgesetz (BayKrG); Berliner Gesetz zur Neuregelung des Krankenhausrechts; Krankenhausentwicklungsgesetz Brandenburg (BbgKHEG); Bremisches Krankenhausgesetz (BrmKrHG); Hamburgisches Krankenhausgesetz (HmbKHG); Hessisches Krankenhausgesetz 2011 (HKHG 2011); Krankenhausgesetz f\u00fcr das Land Mecklenburg-Vorpommern (LKHG M-V); Nieders\u00e4chsisches Krankenhausgesetz (NKHG); Krankenhausgestaltungsgesetz des Landes Nordrhein-Westfalen (KHGG NRW); Landeskrankenhausgesetz Rheinland-Pfalz (LKG Rh-Pf); Saarl\u00e4ndisches Krankenhausgesetz (SKHG); Gesetz zur Neuordnung des Krankenhauswesens (S\u00e4chsisches Krankenhausgesetz - S\u00e4chsKHG); Krankenhausgesetz Sachsen-Anhalt (KHG LSA); Gesetz zur Ausf\u00fchrung des Krankenhausfinanzierungsgesetzes (AG-KHG) in Schleswig-Holstein; Th\u00fcringisches Krankenhausgesetz (Th\u00fcr KHG). HR: Health Care Act (OG 150/08, 71/10, 139/10, 22/11, 84/11, 12/12, 70/12, 144/12). SI: Law of Health Services, Official Gazette of the RS, No. 23/2005, Articles 1, 3 and 62-64; Infertility Treatment and Procedures of the Biomedically-Assisted Procreation Act, Official Gazette of the RS, No. 70/00, Articles 15 and 16; and Supply of Blood Act (ZPKrv-1), Official Gazette of RS, no. 104/06, Articles 5 and 8. With respect to Investment liberalisation \u2013 Market access, National treatment: In FR: For hospital and ambulance services, residential health facilities (other than hospital services) and social services, an authorisation is necessary in order to exercise management functions. The authorisation process takes into account the availability of local managers. Companies can take any legal forms, except those reserved to liberal professions. Measures: FR: Loi 90-1258 relative \u00e0 l'exercice sous forme de soci\u00e9t\u00e9 des professions lib\u00e9rales, Loi n\u00b02011-940 du 10 ao\u00fbt 2011 modifiant certaines dipositions de la loi n\u00b02009-879 dite HPST, Loi n\u00b047-1775 portant statut de la coop\u00e9ration; and Code de la sant\u00e9 publique. Reservation No. 14 - Tourism and travel related services Sector \u2013 sub-sector: Tourism and travel related services - hotels, restaurants and catering; travel agencies and tour operators services (including tour managers); tourist guides services Industry classification: CPC 641, 642, 643, 7471, 7472 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment: In BG: Incorporation (no branches) is required. Tour operation or travel agency services may be provided by a person established in the EEA if, upon establishment in the territory of Bulgaria, the said person presents a copy of a document certifying the right thereof to practice that activity and a certificate or another document issued by a credit institution or an insurer containing data of the existence of insurance covering the liability of the said person for damage which may ensue as a result of a culpable non-fulfilment of professional duties. The number of foreign managers may not exceed the number of managers who are Bulgarian nationals, in cases where the public (state or municipal) share in the equity capital of a Bulgarian company exceeds 50 per cent. EEA nationality requirement for tourist guides (CPC 641, 642, 643, 7471, 7472). Measures: BG: Law for Tourism, Articles 61, 113 and 146. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In CY: A licence to establish and operate a tourism and travel company or agency, as well as the renewal of an operating licence of an existing company or agency, shall be granted only to European Union natural or legal persons. No non-resident company except those established in another Member State, can provide in the Republic of Cyprus, on an organised or permanent basis, the activities referred to under Article 3 of the abovementioned Law, unless represented by a resident company. The provision of tourist guide services and travel agencies and tour operators services requires nationality of a Member State (CPC 7471, 7472). Measures: CY: The Tourism and Travel Offices and Tourist Guides Law 1995 (Law 41(I)/1995) as amended). With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services \u2013 Market access, National treatment, Most-favoured nation treatment: In EL: Third-country nationals have to obtain a diploma from the Tourist Guide Schools of the Greek Ministry of Tourism, in order to be entitled to the right of practicing the profession. By exception, the right of practicing the profession can be temporarily (up to one year) accorded to third-country nationals under certain explicitly defined conditions, by way of derogation of the above mentioned provisions, in the event of the confirmed absence of a tourist guide for a specific language. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment,: In ES (for ES applies also to the regional level of government): Nationality of a Member State is required for the provision of tourist guide services (CPC 7472). In HR: EEA or Swiss nationality is required for hospitality and catering services in households and rural homesteads (CPC 641, 642, 643, 7471, 7472). Measures: EL: Presidential Degree 38/2010, Ministerial Decision 165261/IA/2010 (Gov. Gazette 2157/B), Article 50 of the law 4403/2016, Article 47 of the law 4582/2018 (Gov. Gazette 208/A). ES: Andaluc\u00eda: Decreto 8/2015, de 20 de enero, Regulador de gu\u00edas de turismo de Andaluc\u00eda; Arag\u00f3n: Decreto 21/2015, de 24 de febrero, Reglamento de Gu\u00edas de turismo de Arag\u00f3n; Cantabria: Decreto 51/2001, de 24 de julio, Article 4, por el que se modifica el Decreto 32/1997, de 25 de abril, por el que se aprueba el reglamento para el ejercicio de actividades tur\u00edsticoinformativas privadas; Castilla y Le\u00f3n: Decreto 25/2000, de 10 de febrero, por el que se modifica el Decreto 101/1995, de 25 de mayo, por el que se regula la profesi\u00f3n de gu\u00eda de turismo de la Comunidad Aut\u00f3noma de Castilla y Le\u00f3n; Castilla la Mancha: Decreto 86/2006, de 17 de julio, de Ordenaci\u00f3n de las Profesiones Tur\u00edsticas; Catalu\u00f1a: Decreto Legislativo 3/2010, de 5 de octubre, para la adecuaci\u00f3n de normas con rango de ley a la Directiva 2006/123/CE, del Parlamento y del Consejo, de 12 de diciembre de 2006, relativa a los servicios en el mercado interior, Article 88; Comunidad de Madrid: Decreto 84/2006, de 26 de octubre del Consejo de Gobierno, por el que se modifica el Decreto 47/1996, de 28 de marzo; Comunidad Valenciana: Decreto 90/2010, de 21 de mayo, del Consell, por el que se modifica el reglamento regulador de la profesi\u00f3n de gu\u00eda de turismo en el \u00e1mbito territorial de la Comunitat Valenciana, aprobado por el Decreto 62/1996, de 25 de marzo, del Consell; Extremadura: Decreto 37/2015, de 17 de marzo; Galicia: Decreto 42/2001, de 1 de febrero, de Refundici\u00f3n en materia de agencias de viajes, guias de turismo y turismo activo; Illes Balears: Decreto 136/2000, de 22 de septiembre, por el cual se modifica el Decreto 112/1996, de 21 de junio, por el que se regula la habilitaci\u00f3n de gu\u00eda tur\u00edstico en las Islas Baleares; Islas Canarias: Decreto 13/2010, de 11 de febrero, por el que se regula el acceso y ejercicio de la profesi\u00f3n de gu\u00eda de turismo en la Comunidad Aut\u00f3noma de Canarias, Article 5; La Rioja: Decreto 14/2001, de 4 de marzo, Reglamento de desarrollo de la Ley de Turismo de La Rioja; Navarra: Decreto Foral 288/2004, de 23 de agosto. Reglamento para actividad de empresas de turismo activo y cultural de Navarra. Principado de Asturias: Decreto 59/2007, de 24 de mayo, por el que se aprueba el Reglamento regulador de la profesi\u00f3n de Gu\u00eda de Turismo en el Principado de Asturias; and Regi\u00f3n de Murcia: Decreto n.o 37/2011, de 8 de abril, por el que se modifican diversos decretos en materia de turismo para su adaptaci\u00f3n a la ley 11/1997, de 12 de diciembre, de turismo de la Regi\u00f3n de Murcia tras su modificaci\u00f3n por la ley 12/2009, de 11 de diciembre, por la que se modifican diversas leyes para su adaptaci\u00f3n a la directiva 2006/123/CE, del Parlamento Europeo y del Consejo de 12 de diciembre de 2006, relativa a los servicios en el mercado interior. HR: Hospitality and Catering Industry Act (OG 85/15, 121/16, 99/18, 25/19, 98/19, 32/20 and 42/20); and Act on Provision of Tourism Services (OG No. 130/17, 25/19, 98/19 and 42/20). With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 Market access, National treatment: In HU: The supply of travel agent and tour operator services, and tourist guide services on a cross-border basis is subject to a licence issued by the Hungarian Trade Licensing Office. Licences are reserved to EEA nationals and legal persons having their seats in the EEA (CPC 7471, 7472). In IT (applies also to the regional level of government): tourist guides from non-European Union countries need to obtain a specific licence from the region in order to act as a professional tourist guide. Tourist guides from Member States can work freely without the requirement for such a licence. The licence is granted to tourist guides demonstrating adequate competence and knowledge (CPC 7472). Measures: HU: Act CLXIV of 2005 on Trade, Government Decree No. 213/1996 (XII.23.) on Travel Organisation and Agency Activities. IT: Law 135/2001 Articles 7.5 and 6; and Law 40/2007 (DL 7/2007). Reservation No. 15 - Recreational, cultural and sporting services Sector \u2013 sub-sector: Recreational services; other sporting services Industry classification: CPC 962, part of 96419 Type of reservation: Market access National treatment Senior management and boards of directors Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: Other sporting services (CPC 96419) With respect to Investment liberalisation \u2013 National treatment, Senior management and boards of directors and Cross-border trade in services \u2013National treatment: In AT (applies to the regional level of government): The operation of ski schools and mountain guide services is governed by the laws of the Bundesl\u00e4nder. The provision of these services may require nationality of a Member State of the EEA. Enterprises may be required to appoint a managing director who is a national of a Member State of the EEA. With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013National treatment: In CY: Nationality requirement for the establishment of a dance school and nationality requirement for physical instructors. Measures: AT: K\u00e4rntner Schischulgesetz, LGBL. Nr. 53/97; K\u00e4rntner Berg- und Schif\u00fchrergesetz, LGBL. Nr. 25/98; N\u00d6- Sportgesetz, LGBL. Nr. 5710; O\u00d6- Sportgesetz, LGBl. Nr. 93/1997; Salzburger Schischul- und Snowboardschulgesetz, LGBL. Nr. 83/89; Salzburger Bergf\u00fchrergesetz, LGBL. Nr. 76/81; Steierm\u00e4rkisches Schischulgesetz, LGBL. Nr.58/97; Steierm\u00e4rkisches Berg- und Schif\u00fchrergesetz, LGBL. Nr. 53/76; Tiroler Schischulgesetz. LGBL. Nr. 15/95; Tiroler Bergsportf\u00fchrergesetz, LGBL. Nr. 7/98; Vorarlberger Schischulgesetz, LGBL. Nr. 55/02 \u00a74 (2)a; Vorarlberger Bergf\u00fchrergesetz, LGBL. Nr. 54/02; and Wien: Gesetz \u00fcber die Unterweisung in Wintersportarten, LGBL. Nr. 37/02. CY: Law 65(I)/1997 as amended; and Law 17(I) /1995 as amended. Reservation No. 16 - Transport services and services auxiliary to transport services Sector \u2013 sub-sector: Transport services - fishing and water transportation \u2013 any other commercial activity undertaken from a ship; water transportation and auxiliary services for water transport; rail transport and auxiliary services to rail transport; road transport and services auxiliary to road transport; services auxiliary to air transport services Industry classification: ISIC Rev. 3.1 0501, 0502; CPC 5133, 5223, 711, 712, 721, 741, 742, 743, 744, 745, 748, 749, 7461, 7469, 83103, 86751, 86754, 8730, 882 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Maritime transport and auxiliary services for maritime transport. Any commercial activity undertaken from a ship (ISIC Rev. 3.1 0501, 0502; CPC 5133, 5223, 721, Part of 742, 745, 74540, 74520, 74590, 882) With respect to Investment liberalisation \u2013 Market access, and Cross-border trade in services \u2013 Market access: In EU: For port services, the managing body of a port, or the competent authority, may limit the number of providers of port services for a given port service. Measures: EU: Article 6 of Regulation (EU) 2017/352 of the European Parliament and of the Council (10). With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors; Cross-border trade in services \u2013 Market access, National treatment: In BG: The carriage and any activities related to hydraulic-engineering and underwater technical works, prospecting and extraction of mineral and other inorganic resources, pilotage, bunkering, receipt of waste, water-and-oil mixtures and other such, performed by vessels in the internal waters, and the territorial sea of Bulgaria, may only be performed by vessels flying the Bulgarian flag or vessels flying the flag of another Member State. The number of the service suppliers at the ports may be limited depending on the objective capacity of the port, which is decided by an expert commission, set up by the Minister of Transport, Information Technology and Communications. Nationality requirement for supporting services. The master and the chief engineer of the vessel shall mandatorily be nationals of a Member State of the EEA, or of the Swiss Confederation. (ISIC Rev. 3.1 0501, 0502, CPC 5133, 5223, 721, 74520, 74540, 74590, 882). Measures: BG: Merchant Shipping Code; Law For the Sea Water, Inland Waterways and Ports of the Republic of Bulgaria; Ordinance for the condition and order for selection of Bulgarian carriers for carriage of passengers and cargoes under international treaties; and Ordinance 3 for servicing of unmanned vessels. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access: In BG: Regarding supporting services for public transport carried out in Bulgarian ports, in ports having national significance, the right to perform supporting activities is granted through a concession contract. In ports having regional significance, this right is granted by a contract with the owner of the port (CPC 74520, 74540, 74590). Measures: BG: Merchant Shipping Code; Law For the Sea Water, Inland Waterways and Ports of the Republic of Bulgaria. With respect to Cross-border trade in services \u2013 Local presence: In DK: Pilotage-providers may only conduct pilotage service in Denmark, if they are domiciled in the EEA and registered and approved by the Danish Authorities in accordance with the Danish Act on Pilotage (CPC 74520). Measures: DK: Danish Pilotage Act, \u00a718. With respect to Investment liberalisation - Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services - Market access, National treatment, Most-favoured-nation treatment: In DE (applies also to the regional level of government): A vessel that does not belong to a national of a Member State may only be used for activities other than transport and auxiliary services in the German federal waterways after specific authorisation. Waivers for non- European Union vessels may only be granted if no European Union vessels are available or if they are available under very unfavourable conditions, or on the basis of reciprocity. Waivers for vessels flying under the United Kingdom flag may be granted on the basis of reciprocity (\u00a7 2 paragraph 3 K\u00fcSchVO). All activities falling within the scope of the pilot law are regulated and accreditation is restricted to nationals of the EEA or the Swiss Confederation. Provision and Operation of facilities for pilotage is restricted to public authorities or companies, which are designated by them. For rental or leasing of seagoing vessels with or without operators, and for rental or leasing without operator of non-seagoing vessels, the conclusion of contracts for freight transport by ships flying a foreign flag or the chartering of such vessels may be restricted, depending on the availability of ships flying under the German flag or the flag of another Member State. Transactions between residents and non-residents concerning: (i) rental of inland waterway transport vessels, which are not registered in the economic area; (ii) transport of freight with such inland waterway transport vessels; or (iii) towing services by such inland waterway transport vessels, within the economic area may be restricted (Water transport, Supporting services for water transport, Rental of ships, Leasing services of ships without operators (CPC 721, 745, 83103, 86751, 86754, 8730)). Measures: DE: Gesetz \u00fcber das Flaggenrecht der Seeschiffe und die Flaggenf\u00fchrung der Binnenschiffe (Flaggenrechtsgesetz; Flag Protection Act); Verordnung \u00fcber die K\u00fcstenschifffahrt (K\u00fcSchV); Gesetz \u00fcber die Aufgaben des Bundes auf dem Gebiet der Binnenschiffahrt (Binnenschiffahrtsaufgabengesetz - BinSchAufgG); Verordnung \u00fcber Bef\u00e4higungszeugnisse in der Binnenschiffahrt (Binnenschifferpatentverordnung - BinSchPatentV); Gesetz \u00fcber das Seelotswesen (Seelotsgesetz - SeeLG); Gesetz \u00fcber die Aufgaben des Bundes auf dem Gebiet der Seeschiffahrt (Seeaufgabengesetz - SeeAufgG); and Verordnung zur Eigensicherung von Seeschiffen zur Abwehr \u00e4u\u00dferer Gefahren (See-Eigensicherungsverordnung - SeeEigensichV). With respect to Investment liberalisation - Market access, National treatment and Cross-border trade in services - Market access, National treatment: In FI: supporting services for maritime transport when provided in Finnish maritime waters are reserved to fleets operating under the national, Union or Norwegian flag (CPC 745). Measures: FI: Merilaki (Maritime Act) (674/1994); and Laki elinkeinon harjoittamisen oikeudesta (Act on the Right to Carry on a Trade) (122/1919), s. 4. With respect to Investment liberalisation - Market access: In EL: Public monopoly imposed in port areas for cargo handling services (CPC 741). In IT: An economic needs test is applied for maritime cargo-handling services. Main criteria: number of and impact on existing establishments, population density, geographic spread and creation of new employment (CPC 741). Measures: EL: Code of Public Maritime Law (Legislative Decree 187/1973). IT: Shipping Code; Law 84/1994; and Ministerial decree 585/1995. (b) Rail transport and auxiliary services to rail transport (CPC 711, 743) With respect to Investment liberalisation - Market access, National treatment, and Cross-border trade in services - Market access, National treatment: In BG: Only nationals of a Member State may provide rail transport or supporting services for rail transport in Bulgaria. A licence to carry out passenger or freight transportation by rail is issued by the Minister of Transport to railway operators registered as traders (CPC 711, 743). Measures: BG: Law for Railway Transport, Articles 37 and 48. With respect to Investment liberalisation - Market access: In LT: The exclusive rights for the provision of transit services are granted to railway undertakings which are owned, or whose stock is 100 per cent owned, by the state (CPC 711). Measures: LT: Railway transport Code of the Republic of Lithuania of 22 April 2004 No. IX-2152 as amended by 8 June 2006 No. X-653. (c) Road transport and services auxiliary to road transport (CPC 712, 7121, 7122, 71222, 7123) For road transport services not covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement With respect to Investment liberalisation - Market access, National treatment, and Cross-border trade in services - Market access, National treatment: In AT (with respect also to Most-favoured-nation treatment): For passenger and freight transportation, exclusive rights or authorisations may only be granted to nationals of the Contracting Parties of the EEA and to legal persons of the Union having their headquarters in Austria. Licences are granted on non\u2013 discriminatory terms, under condition of reciprocity (CPC 712). Measures: AT: G\u00fcterbef\u00f6rderungsgesetz (Goods Transportation Act), BGBl. Nr. 593/1995; \u00a7 5; Gelegenheitsverkehrsgesetz (Occasional Traffic Act), BGBl. Nr. 112/1996; \u00a7 6; and Kraftfahrliniengesetz (Law on Scheduled Transport), BGBl. I Nr. 203/1999 as amended, \u00a7\u00a7 7 and 8. With respect to Investment liberalisation - National treatment, Most-favoured-nation treatment: In EL: For operators of road freight transport services. In order to engage in the occupation of road freight transport operator a Hellenic licence is needed. Licences are granted on non\u2013 discriminatory terms, under condition of reciprocity (CPC 7123). Measures: EL: Licensing of road freight transport operators: Greek law 3887/2010 (Government Gazette A' 174), as amended by Article 5 of law 4038/2012 (Government Gazette A' 14). With respect to Investment liberalisation - Market access: In IE: Economic needs test for intercity bussing services. Main criteria: number of and impact on existing establishments, population density, geographical spread, impact on traffic conditions and creation of new employment (CPC 7121, CPC 7122). In MT: Taxis - numerical restrictions on the number of licences apply. Karozzini (horse drawn carriages): Numerical Restrictions on the number of licences apply (CPC 712). In PT: Economic needs test for limousine services. Main criteria: number of and impact on existing establishments, population density, geographic spread, impact on traffic conditions and creation of new employment (CPC 71222). Measures: IE: Public Transport Regulation Act 2009. MT: Taxi Services Regulations (SL499.59). PT: Decree-Law 41/80, August 21. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services - Local presence: In CZ: Incorporation in the Czech Republic is required (no branches). Measures: CZ: Act no. 111/1994. Coll. on Road Transport. With respect to Investment liberalisation - Market access, National treatment and Cross-border trade in services - Market access, National treatment, Most-favoured-nation treatment: In SE: In order to engage in the occupation of road transport operator, a Swedish licence is needed. Criteria for receiving a taxi licence include that the company has appointed a natural person to act as the transport manager (a de facto residency requirement \u2013 see the Swedish reservation on types of establishment). Measures: SE: Yrkestrafiklag (2012:210) (Act on professional traffic); Yrkestrafikf\u00f6rordning (2012:237) (Government regulation on professional traffic); Taxitrafiklag (2012:211) (Act on Taxis); and Taxitrafikf\u00f6rordning (2012:238) (Government regulation on taxis). With respect to Cross-border trade in services \u2013 Local presence: In SK: A taxi service concession and a permit for the operation of taxi dispatching can be granted to a person who has a residence or place of establishment in the territory of the Slovak Republic or in another EEA Member State. Measures: Act 56/2012 Coll. on Road Transport (d) Services auxiliary to air transport services With respect to Investment liberalisation - Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In EU: For groundhandling services, establishment within the Union territory may be required. The level of openness of groundhandling services depends on the size of airport. The number of suppliers in each airport may be limited. For \"big airports\", this limit may not be less than two suppliers. Measures: EU: Council Directive 96/67/EC of 15 October 1996 (11). In BE (applies also to the regional level of government): For groundhandling services, reciprocity is required. Measures: BE: Arr\u00eat\u00e9 Royal du 6 novembre 2010 r\u00e9glementant l'acc\u00e8s au march\u00e9 de l'assistance en escale \u00e0 l'a\u00e9roport de Bruxelles-National (Article 18); Besluit van de Vlaamse Regering betreffende de toegang tot de grondafhandelingsmarkt op de Vlaamse regionale luchthavens (Article 14); and Arr\u00eat\u00e9 du Gouvernement wallon r\u00e9glementant l'acc\u00e8s au march\u00e9 de l'assistance en escale aux a\u00e9roports relevant de la R\u00e9gion wallonne (Article14). (e) Supporting services for all modes of transport (part of CPC 748) With respect to Cross-border trade in services \u2013 Local presence: The EU (applies also to the regional level of government): Customs clearance services may only be provided by Union residents or legal persons established in the Union. Measures: EU: Regulation (EU) No 952/2013 of the European Parliament and of the Council (12) Reservation No. 17 - Energy related activities Sector \u2013 sub-sector: Energy related activities - mining and quarrying; production, transmission and distribution on own account of electricity, gas, steam and hot water; pipeline transportation of fuels; storage and warehouse of fuels transported through pipelines; and services incidental to energy distribution Industry classification: ISIC Rev. 3.1 10, 11, 12, 13, 14, 40, CPC 5115, 63297, 713, part of 742, 8675, 883, 887 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Mining and quarrying (ISIC Rev. 3.1 10, 11, 12, 13, 14, CPC 5115, 7131, 8675, 883) With respect to Investment liberalisation \u2013 Market access: In NL: The exploration for and exploitation of hydrocarbons in the Netherlands is always performed jointly by a private company and the public (limited) company designated by the Minister of Economic Affairs. Articles 81 and 82 of the Mining Act stipulate that all shares in this designated company must be directly or indirectly held by the Dutch State (ISIC Rev. 3.1 10, 3.1 11, 3.1 12, 3.1 13, 3.1 14). In BE: The exploration for and exploitation of mineral resources and other non-living resources in territorial waters and the continental shelf are subject to concession. The concessionaire must have an address for service in Belgium (ISIC Rev. 3.1:14). In IT (applies also to the regional level of government for exploration): Mines belonging to the State have specific exploration and mining rules. Prior to any exploitation activity, a permit for exploration is needed (\"permesso di ricerca\", Article 4 Royal Decree 1447/1927). This permit has a duration, defines exactly the borders of the ground under exploration and more than one exploration permit may be granted for the same area to different persons or companies (this type of licence is not necessarily exclusive). In order to cultivate and exploit minerals, an authorisation (\"concessione\", Article 14) from the regional authority is required (ISIC Rev. 3.1 10, 3.1 11, 3.1 12, 3.1 13, 3.1 14, CPC 8675, 883). Measures BE: Arr\u00eat\u00e9 Royal du 1er septembre 2004 relatif aux conditions, \u00e0 la d\u00e9limitation g\u00e9ographique et \u00e0 la proc\u00e9dure d'octroi des concessions d'exploration et d'exploitation des ressources min\u00e9rales et autres ressources non vivantes de la mer territoriale et du plateau continental. IT: Exploration services: Royal Decree 1447/1927; and Legislative Decree 112/1998, Article 34. NL: Mijnbouwwet (Mining Act). With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment: In BG: The activities of prospecting or exploration of underground natural resources on the territory of the Republic of Bulgaria, in the continental shelf and in the exclusive economic zone in the Black Sea are subject to permission, while the activities of extraction and exploitation are subject to concession granted under the Underground Natural Resources Act. It is forbidden for companies registered in preferential tax treatment jurisdictions (that is, offshore zones) or related, directly or indirectly, to such companies to participate in open procedures for granting permits or concessions for prospecting, exploration or extraction of natural resources, including uranium and thorium ores, as well as to operate an existing permit or concession which has been granted, as such operations are precluded, including the possibility to register the geological or commercial discovery of a deposit as a result of exploration. The mining of uranium ore is closed by Decree of the Council of Ministers No. 163 of 20.08.1992. With regard to exploration and mining of thorium ore, the general regime of permits and concessions applies. Decisions to allow the exploration or mining of thorium ore are taken on a non-discriminatory individual case-by-case basis. According to Decision of the National Assembly of the Republic of Bulgaria of 18 Jan 2012 (ch. 14 June 2012) any usage of hydraulic fracturing technology that is, fracking, for activities of prospecting, exploration or extraction of oil and gas is forbidden. Exploration and extraction of shale gas is forbidden (ISIC Rev. 3.1 10, 3.1 11, 3.112, 3.1 13,3.1 14). Measures: BG: Underground Natural Resources Act; Concessions Act; Law on Privatisation and Post-Privatisation Control; Safe Use of Nuclear Energy Act; Decision of the National Assembly of the Republic of Bulgaria of 18 Jan 2012; Economic and Financial Relations with Companies Registered in Preferential Tax Treatment Jurisdictions, the Persons Controlled Thereby and Their Beneficial Owners Act; and Subsurface Resources Act. With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment: In CY: The Council of Ministers may refuse to allow the activities of prospecting, exploration and exploitation of hydrocarbons to be carried out by any entity which is effectively controlled by the United Kingdom or by nationals of the United Kingdom. After the granting of an authorisation, no entity may come under the direct or indirect control of the United Kingdom or a national of the United Kingdom without the prior approval of the Council of Ministers. The Council of Ministers may refuse to grant an authorisation to an entity which is effectively controlled by the United Kingdom or by a national of the United Kingdom, if the United Kingdom does not grant entities of the Republic or entities of Member States as regards access to and exercise of the activities of prospecting, exploring for and exploiting hydrocarbons, treatment comparable to that which the Republic or Member State grants entities from the United Kingdom (ISIC Rev 3.1 1110). Measures: CY: The Hydrocarbons (Prospecting, Exploration and Exploitation Law) of 2007, (Law 4(I)/2007) as amended. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border services \u2013 Local presence: In SK: For mining, activities related to mining and geological activity, incorporation in the EEA is required (no branching). Mining and prospecting activities covered by Act of the Slovak Republic 44/1988 on protection and exploitation of natural resources are regulated on a non-discriminatory basis, including through public policy measures seeking to ensure the conservation and protection of natural resources and the environment such as the authorisation or prohibition of certain mining technologies. For greater certainty, such measures include the prohibition of the use of cyanide leaching in the treatment or refining of minerals, the requirement of a specific authorisation in the case of fracking for activities of prospecting, exploration or extraction of oil and gas, as well as prior approval by local referendum in the case of nuclear/radioactive mineral resources. This does not increase the non-conforming aspects of the existing measure for which the reservation is taken. (ISIC Rev. 3.1 10, 3.1 11, 3.1 12, 3.1 13, 3.1 14, CPC 5115, 7131, 8675 and 883). Measures SK: Act 51/1988 on Mining, Explosives and State Mining Administration; and Act 569/2007 on Geological Activity, Act 44/1988 on protection and exploitation of natural resources. With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Local presence: In FI: The exploration for and exploitation of mineral resources are subject to a licensing requirement, which is granted by the Government in relation to the mining of nuclear material. A permit of redemption for a mining area is required from the Government. Permission may be granted to a natural person resident in the EEA or a legal person established in the EEA. An economic needs test may apply (ISIC Rev. 3.1 120, CPC 5115, 883, 8675). In IE: Exploration and mining companies operating in Ireland are required to have a presence there. In the case of minerals exploration, there is a requirement that companies (Irish and foreign) employ either the services of an agent or a resident exploration manager in Ireland while work is being undertaken. In the case of mining, it is a requirement that a State Mining Lease or License be held by a company incorporated in Ireland. There are no restrictions as to ownership of such a company (ISIC Rev. 3.1 10, 3.1 13, 3.1 14, CPC 883). Measures FI: Kaivoslaki (Mining Act) (621/2011); and Ydinenergialaki (Nuclear Energy Act) (990/1987). IE: Minerals Development Acts 1940 \u2013 2017; and Planning Acts and Environmental Regulations. With respect only to Investment \u2013 Market access, National treatment and Cross-border trade in services \u2013 Local presence: In SI: The exploration for and exploitation of mineral resources, including regulated mining services, are subject to establishment in or citizenship of the EEA, the Swiss Confederation or an OECD Member(ISIC Rev. 3.1 10, ISIC Rev. 3.1 11, ISIC Rev. 3.1 12, ISIC Rev. 3.1 13, ISIC Rev. 3.1 14, CPC 883, CPC 8675). Measures SI: Mining Act 2014. (b) Production, transmission and distribution on own account of electricity, gas, steam and hot water; pipeline transportation of fuels; storage and warehouse of fuels transported through pipelines; services incidental to energy distribution (ISIC Rev. 3.1 40, 3.1 401, CPC 63297, 713, part of 742, 74220, 887) With respect to Investment liberalisation \u2013 Market access: In DK: The owner or user intending to establish gas infrastructure or a pipeline for the transport of crude or refined petroleum and petroleum products and of natural gas must obtain a permit from the local authority before commencing work. The number of such permits which are issued may be limited (CPC 7131). In MT: EneMalta plc has a monopoly for the provision of electricity (ISIC Rev. 3.1 401; CPC 887). In NL: the ownership of the electricity network and the gas pipeline network are exclusively granted to the Dutch government (transmission systems) and other public authorities (distribution systems) (ISIC Rev. 3.1 040, CPC 71310). Measures: DK: Lov om naturgasforsyning, LBK 1127 05/09/2018, lov om varmeforsyning, LBK 64 21/01/2019, lov om Energinet, LBK 997 27/06/2018. Bekendtg\u00f8relse nr. 1257 af 27. november 2019 om indretning, etablering og drift af olietanke, r\u00f8rsystemer og pipelines (Order no. 1257 of November 27th, 2019, on the arrangement, establishment and operation of oil tanks, piping systems and pipelines). MT: EneMalta Act Cap. 272 and EneMalta (Transfer of Assets, Rights, Liabilities & Obligations) Act Cap. 536. NL: Elektriciteitswet 1998; Gaswet. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 National treatment, Local presence: In AT: With regard to the transportation of gas authorisation is only granted to nationals of a Member State of the EEA domiciled in the EEA. Enterprises and partnerships must have their seat in the EEA. The operator of the network must appoint a Managing Director and a Technical Director who is responsible for the technical control of the operation of the network, both of whom must be nationals of a member state of the EEA. The competent authority may waive the nationality and domiciliation requirements where the operation of the network is considered to be in the public interest. For the transportation of goods other than gas and water, the following applies: (i) with regard to natural persons, authorisation is only granted to EEA-nationals who must have a seat in Austria; and (ii) enterprises and partnerships must have their seat in Austria. An Economic Needs Test or interest test is applied. Cross border pipelines must not jeopardise Austria's security interests and its status as a neutral country. Enterprises and partnerships have to appoint a managing director who must be a national of a member state of the EEA. The competent authority may waive the nationality and seat requirements if the operation of the pipeline is considered to be in the national economic interest (CPC 713). Measures: AT: Rohrleitungsgesetz (Law on Pipeline Transport), BGBl. Nr. 411/1975, \u00a7 5(1) and (2), \u00a7\u00a7 5 (1) and (3), 15, 16; and Gaswirtschaftsgesetz 2011(Gas Act), BGBl. I Nr. 107/2011, Articles 43 and 44, Articles 90 and 93. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of director and Cross-border trade in services \u2013 (applies only to the regional level of government) National treatment, Local presence: In AT: With regard to transmission and distribution of electricity, authorisation is only granted to nationals of a Member State of the EEA domiciled in the EEA. If the operator appoints a managing director or a leaseholder, the domicile requirement is waived. Legal persons (enterprises) and partnerships must have their seat in the EEA. They must appoint a managing director or a leaseholder, both of whom must be nationals of a Member State of the EEA domiciled in the EEA. The competent authority may waive the domicile and nationality requirements where the operation of the network is considered to be in the public interest (ISIC Rev. 3.1 40, CPC 887). Measures: AT: Burgenl\u00e4ndisches Elektrizit\u00e4tswesengesetz 2006, LGBl. Nr. 59/2006 as amended; Nieder\u00f6sterreichisches Elektrizit\u00e4tswesengesetz, LGBl. Nr. 7800/2005 as amended; Landesgesetz, mit dem das Ober\u00f6sterreichische Elektrizit\u00e4tswirtschafts- und -organisationsgesetz 2006 erlassen wird (O\u00f6. ElWOG 2006), LGBl. Nr. 1/2006 as amended; Salzburger Landeselektrizit\u00e4tsgesetz 1999 (LEG), LGBl. Nr. 75/1999 as amended; Gesetz vom 16. November 2011 \u00fcber die Regelung des Elektrizit\u00e4tswesens in Tirol (Tiroler Elektrizit\u00e4tsgesetz 2012 \u2013 TEG 2012), LGBl. Nr. 134/2011; Gesetz \u00fcber die Erzeugung, \u00dcbertragung und Verteilung von elektrischer Energie (Vorarlberger Elektrizit\u00e4tswirtschaftsgesetz), LGBl. Nr. 59/2003 as amended; Gesetz \u00fcber die Neuregelung der Elektrizit\u00e4tswirtschaft (Wiener Elektrizit\u00e4tswirtschaftsgesetz 2005 \u2013 WElWG 2005), LGBl. Nr. 46/2005; Steierm\u00e4rkisches Elektrizit\u00e4tswirtschafts- und Organisationsgesetz(ELWOG), LGBl. Nr. 70/2005; and K\u00e4rntner Elektrizit\u00e4tswirtschafts-und Organisationsgesetz(ELWOG), LGBl. Nr. 24/2006. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Local presence: In CZ: For electricity generation, transmission, distribution, trading, and other electricity market operator activities, as well as gas generation, transmission, distribution, storage and trading, as well as heat generation and distribution, authorisation is required. Such authorisation may only be granted to a natural person with a residence permit or a legal person established in the Union. Exclusive rights exist with regard to electricity and gas transmission and market operator licences (ISIC Rev. 3.1 40, CPC 7131, 63297, 742, 887). In LT: The licences for transmission, distribution, public supply and organizing of trade of electricity may only be issued to legal persons established in the Republic of Lithuania or branches of foreign legal persons or other organisations of another Member State established in the Republic Lithuania. The permits to generate electricity, develop electricity generation capacities and build a direct line may be issued to individuals with residency in the Republic of Lithuania or to legal persons established in the Republic of Lithuania, or to branches of legal persons or other organizations of another Member States established in the Republic of Lithuania. This reservation does not apply to consultancy services related to the transmission and distribution on a fee or contract basis of electricity (ISIC Rev. 3.1 401, CPC 887). In the case of fuels, establishment is required. Licences for transmission and distribution, storage of fuels and liquefaction of natural gas may only be issued to legal persons established in the Republic of Lithuania or branches of legal persons or other organisations (subsidiaries) of another Member State established in the Republic Lithuania. This reservation does not apply to consultancy services related to the transmission and distribution on a fee or contract basis of fuels (CPC 713, CPC 887). In PL: the following activities are subject to licensing under the Energy Law Act: (i) generation of fuels or energy, except for: generation of solid or gaseous fuels; generation of electricity using electricity sources of the total capacity of not more than 50 MW other than renewable energy sources; cogeneration of electricity and heat using sources of the total capacity of not more than 5 MW other than renewable energy sources; generation of heat using the sources of the total capacity of not more than 5 MW; (ii) storage of gaseous fuels in storage installations, liquefaction of natural gas and regasification of liquefied natural gas at LNG installations, as well as the storage of liquid fuels, except for: the local storage of liquid gas at installations of the capacity of less than 1 MJ/s capacity and the storage of liquid fuels in retail trade; (iii) transmission or distribution of fuels or energy, except for: the distribution of gaseous fuels in grids of less than 1 MJ/s capacity and the transmission or distribution of heat if the total capacity ordered by customers does not exceed 5 MW; (iv) trade in fuels or energy, except for: the trade in solid fuels; the trade in electricity using installations of voltage lower than 1 kV owned by the customer; the trade in gaseous fuels if their annual turnover value does not exceed the equivalent of EUR 100 000; the trade in liquid gas, if the annual turnover value does not exceed EUR 10 000; and the trade in gaseous fuels and electricity performed on commodity exchanges by brokerage houses which conduct the brokerage activity on the exchange commodities on the basis of the Act of 26 October 2000 on commodity exchanges, as well as the trade in heat if the capacity ordered by the customers does not exceed 5 MW. The limits on turnover do not apply to wholesale trade services in gaseous fuels or liquid gas or to retail services of bottled gas. A licence may only be granted by the competent authority to an applicant that has registered their principal place of business or residence in the territory of a Member State of the EEA or the Swiss Confederation (ISIC Rev. 3.1 040, CPC 63297, 74220, CPC 887). Measures: CZ: Act No. 458/2000 Coll on Business conditions and public administration in the energy sectors (The Energy Act). LT: Law on Natural Gas of the Republic of Lithuania of 10 October 2000 No VIII-1973; and Law on electricity of the Republic of Lithuania of 20 July 2000 No VIII-1881. PL: Energy Law Act of 10 April 1997, Articles 32 and 33. With respect to Cross-border trade in services \u2013 Local presence: In SI: The production, trading, supply to final customers, transmission and distribution of electricity and natural gas is subject to establishment in the Union (ISIC Rev. 3.1 4010, 4020, CPC 7131, CPC 887). Measures: SI: Energetski zakon (Energy Act) 2014, Official Gazette RS, nr. 17/2014; and Mining Act 2014. Reservation No. 18 - Agriculture, fishing and manufacturing Sector \u2013 sub-sector: Agriculture, hunting, forestry; animal and reindeer husbandry, fishing and aquaculture; publishing, printing and reproduction of recorded media Industry classification: ISIC Rev. 3.1 011, 012, 013, 014, 015, 1531, 050, 0501, 0502, 221, 222, 323, 324, CPC 881, 882, 88442 Type of reservation: Market access National treatment Most-favoured-nation treatment Performance requirements Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Agriculture, hunting and forestry (ISIC Rev. 3.1 011, 012, 013, 014, 015, 1531, CPC 881) With respect to Investment liberalisation \u2013 National treatment: In IE: Establishment by foreign residents in flour milling activities is subject to authorisation (ISIC Rev. 3.1 1531). Measures: IE: Agriculture Produce (Cereals) Act, 1933. With respect to Investment liberalisation \u2013 Market access, National treatment: In FI: Only nationals of a Member State of the EEA resident in the reindeer herding area may own reindeer and practice reindeer husbandry. Exclusive rights may be granted. In FR: Prior authorisation is required in order to become a member or act as a director of an agricultural cooperative (ISIC Rev. 3.1 011, 012, 013, 014, 015). In SE: Only Sami people may own and practice reindeer husbandry. Measures: FI: Poronhoitolaki (Reindeer Husbandry Act) (848/1990), Chapter 1, s. 4, Protocol 3 to the Accession Treaty of Finland. FR: Code rural et de la p\u00eache maritime. SE: Reindeer Husbandry Act (1971:437), section 1. (b) Fishing and aquaculture (ISIC Rev. 3.1 050, 0501, 0502, CPC 882) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border services: Market access: In FR: A French vessel flying the French flag may be issued a fishing authorisation or may be allowed to fish on the basis of national quotas only when a real economic link on the territory of France is established and the vessel is directed and controlled from a permanent establishment located on the territory of France (ISIC Rev. 3.1 050, CPC 882). Measures: FR: Code rural et de la p\u00eache maritime. (c) Manufacturing - Publishing, printing and reproduction of recorded media (ISIC Rev. 3.1 221, 222, 323, 324, CPC 88442) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border services: Market access, National treatment, Local presence: In LV: Only legal persons incorporated in Latvia, and natural persons of Latvia have the right to found and publish mass media. Branches are not allowed (CPC 88442). Measures: LV: Law on the Press and Other Mass Media, s. 8. With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 Local presence: In DE (applies also to the regional level of government): Each publicly distributed or printed newspaper, journal, or periodical must clearly indicate a \"responsible editor\" (the full name and address of a natural person). The responsible editor may be required to be a permanent resident of Germany, the Union or an EEA Member State. Exceptions may be allowed by the Federal Minister of the Interior (ISIC Rev. 3.1 223, 224). Measures: DE: Regional level: Gesetz \u00fcber die Presse Baden-W\u00fcrttemberg (LPG BW); Bayerisches Pressegesetz (BayPrG); Berliner Pressegesetz (BlnPrG); Brandenburgisches Landespressegesetz (BbgPG); Gesetz \u00fcber die Presse Bremen (BrPrG); Hamburgisches Pressegesetz; Hessisches Pressegesetz (HPresseG); Landespressegesetz f\u00fcr das Land Mecklenburg-Vorpommern (LPrG M-V); Nieders\u00e4chsisches Pressegesetz (NPresseG); Pressegesetz f\u00fcr das Land Nordrhein-Westfalen (Landespressegesetz NRW); Landesmediengesetz (LMG) Rheinland-Pfalz; Saarl\u00e4ndisches Mediengesetz (SMG); S\u00e4chsisches Gesetz \u00fcber die Presse (S\u00e4chsPresseG); Pressegesetz f\u00fcr das Land Sachsen-Anhalt (Landespressegesetz); Gesetz \u00fcber die Presse Schleswig-Holstein (PressG SH); Th\u00fcringer Pressegesetz (TPG). With respect to Investment liberalisation \u2013 Market Access, National Treatment: In IT: In so far as the United Kingdom allow Italian investors to own more than 49 per cent of the capital and voting rights in a publishing company of the United Kingdom, then Italy will allow investors of the United Kingdom to own more than 49 per cent of the capital and voting rights in an Italian publishing company under the same conditions (ISIC Rev. 3.1 221, 222). Measures: IT: Law 416/1981, Article 1 (and subsequent amendments). With respect to Investment liberalisation \u2013 Senior management and boards of directors: In PL: Nationality is required for the editor-in-chief of newspapers and journals (ISIC Rev. 3.1 221, 222). Measures: PL: Act of 26 January 1984 on Press law, Journal of Laws, No. 5, item 24, with subsequent amendments. With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013National treatment, Local presence: In SE: Natural persons who are owners of periodicals that are printed and published in Sweden must reside in Sweden or be nationals of a Member State of the EEA. Owners of such periodicals who are legal persons must be established in the EEA. Periodicals that are printed and published in Sweden and technical recordings must have a responsible editor, who must be domiciled in Sweden (ISIC Rev. 3.1 22, CPC 88442). Measures: SE: Freedom of the press act (1949:105); Fundamental law on Freedom of Expression (1991:1469); and Act on ordinances for the Freedom of the Press Act and the Fundamental law on Freedom of Expression (1991:1559). Schedule of the United Kingdom Reservation No. 1 \u2013 All sectors Reservation No. 2 \u2013 Professional services (all professions except health-related) Reservation No. 3 \u2013 Professional services (veterinary services) Reservation No. 4 \u2013 Research and development services Reservation No. 5 \u2013 Business services Reservation No. 6 \u2013 Communication services Reservation No. 7 \u2013 Transport services and services auxiliary to transport services Reservation No. 8 \u2013 Energy related activities Reservation No. 1 \u2013 All sectors Sector All sectors Type of reservation: Market access National treatment Most favoured nation treatment Senior management and boards of directors Performance requirements Chapter: Investment liberalisation Level of government: Central and Regional (unless otherwise specified) Description: With respect to Investment liberalisation \u2013 Performance requirements The United Kingdom may enforce a commitment or undertaking given in accordance with the provisions governing post-offer undertakings in the City Code on Takeovers and Mergers, or pursuant to Deeds of Undertaking in relation to takeovers or mergers, where the commitment or undertaking is not imposed or required as a condition of approval of the takeover or merger. Measures: The City Code on Takeovers and Mergers Companies Act 2006 Law of Property (Miscellaneous Provisions) Act 1989 as regards enforcement of Deeds of Undertaking in relation to takeovers or mergers With respect to Investment liberalisation \u2013 Market access, National treatment and Senior management and boards of directors This reservation applies only to health, social or education services: The UK, when selling or disposing of its equity interests in, or the assets of, an existing state enterprise or an existing governmental entity providing health, social or education services (CPC 93, 92), may prohibit or impose limitations on the ownership of such interests or assets, and on the ability of owners of such interests and assets to control any resulting enterprise, by investors of the Union or their enterprises. With respect to such a sale or other disposition, the UK may adopt or maintain any measure relating to the nationality of senior management or members of the boards of directors, as well as any measure limiting the number of suppliers. For the purposes of this reservation: (i) any measure maintained or adopted after entry into force of this Agreement that, at the time of the sale or other disposition, prohibits or imposes limitations on the ownership of equity interests or assets or imposes nationality requirements or imposes limitations on the numbers of suppliers as described in this reservation shall be deemed to be an existing measure; and (ii) \"state enterprise\" means an enterprise owned or controlled through ownership interests by the UK and includes an enterprise established after entry into force of this Agreement solely for the purposes of selling or disposing of equity interests in, or the assets of, an existing state enterprise or governmental entity. Measures: As set out in the Description element as indicated above. Reservation No. 2 \u2013 Professional services (all professions except health-related) Sector \u2013 sub-sector: Professional services \u2013 legal services; auditing services Industry classification: Part of CPC 861, CPC 862 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: (a) Legal services (part of CPC 861) In order to provide certain legal services, it may be necessary to obtain authorisation or a licence from a competent authority, or to comply with registration requirements. To the extent that the requirements for obtaining authorisation or a licence, or registration, are non-discriminatory and conform with commitments imposed by Article 194 of this Agreement, they are not listed. These may, for example, include a requirement to having obtained specified qualifications, having completed a recognised period of training, or requiring upon membership an office or a post address within the competent authority's jurisdiction. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, Local presence, National treatment: Residency (commercial presence) may be required by the relevant professional or regulatory body for the provision of some UK domestic legal services. Non-discriminatory legal form requirements apply. Residency may be required by the relevant professional or regulatory body for the provision of certain UK domestic legal services in relation to immigration. Measures: For England and Wales, the Solicitors Act 1974, the Administration of Justice Act 1985 and the Legal Services Act 2007. For Scotland, the Solicitors (Scotland) Act 1980 and the Legal Services (Scotland) Act 2010. For Northern Ireland, the Solicitors (Northern Ireland) Order 1976. For all jurisdictions, the Immigration and Asylum Act 1999. In addition, the measures applicable in each jurisdiction include any requirements set by professional and regulatory bodies. (b) Auditing services (CPC 86211, 86212 other than accounting and bookkeeping services) With respect to Investment liberalisation \u2013 National treatment and cross-border trade in Services \u2013 National treatment: The competent authorities of the UK may recognise the equivalence of the qualifications of an auditor who is a national of the Union or of any third country in order to approve them to act as a statutory auditor in the UK subject to reciprocity (CPC 8621). Measures: The Companies Act 2006 Reservation No. 3 \u2013 Professional services (veterinary services) Sector \u2013 sub-sector: Professional services \u2013 veterinary services Industry classification: CPC 932 Type of reservation: Market access Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: Physical presence is required to perform veterinary surgery. The practice of veterinary surgery is reserved to qualified veterinary surgeons who are registered with the Royal College of Veterinary Surgeons (RCVS). Measures: Veterinary Surgeons Act 1966 Reservation No. 4 \u2013 Research and development services Sector \u2013 sub-sector: Research and development (R&D) services Industry classification: CPC 851, 853 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: For publicly funded research and development (R&D) services benefitting from funding provided by the UK, exclusive rights or authorisations may only be granted to nationals of the UK and to legal persons of the UK having their registered office, central administration or principal place of business in the UK (CPC 851, 853). This reservation is without prejudice to Part Five of this Agreement and to the exclusion of procurement by a Party or subsidies or grants provided by the Parties in Article 123(6) and (7) of this Agreement. Measures: All currently existing and all future research or innovation programmes. Reservation No. 5 \u2013 Business services Sector \u2013 sub-sector: Business services \u2013 rental or leasing services without operators and other business services Industry classification: Part of CPC 831 Type of reservation: Market access National treatment Most-favoured-nation treatment Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: For rental or leasing of aircraft without crew (dry lease) aircraft used by an air carrier of the UK are subject to applicable aircraft registration requirements. A dry lease agreement to which a UK carrier is a party shall be subject to requirements in the national law on aviation safety, such as prior approval and other conditions applicable to the use of third countries' registered aircraft. To be registered, aircraft may be required to be owned either by natural persons meeting specific nationality criteria or by enterprises meeting specific criteria regarding ownership of capital and control (CPC 83104). With respect to computer reservation system (CRS) services, where the UK air carriers are not accorded, by CRS services suppliers operating outside the UK, equivalent (meaning non-discriminatory) treatment to that provided in the UK, or where UK CRS services suppliers are not accorded, by non-UK air carriers, equivalent treatment to that provided in the UK, measures may be taken to accord equivalent discriminatory treatment, respectively, to the non-UK air carriers by the CRS services suppliers operating in the UK, or to the non-UK CRS services suppliers by UK air carriers. Measures: Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community (Recast) as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Operation of Air Services (Amendment etc.) (EU Exit) Regulations (S.I. 2018/1392). Regulation (EC) No 80/2009 of the European Parliament and of the Council of 14 January 2009 on a Code of Conduct for computerised reservation systems and repealing Council Regulation (EEC) No 2299/89, as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Computer Reservation Systems (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1080). Reservation No. 6 \u2013 Communication services Sector \u2013 sub-sector: Communication services - postal and courier services Industry classification: Part of CPC 71235, part of 73210, part of 751 Type of reservation: Market access Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: The organisation of the siting of letter boxes on the public highway, the issuing of postage stamps and the provision of the registered mail service used in the course of judicial or administrative procedures may be restricted in accordance with national legislation. For greater certainty, postal operators may be subject to particular universal service obligations or a financial contribution to a compensation fund. Measures: Postal Services Act 2000 and Postal Services Act 2011 Reservation No. 7 \u2013 Transport services and services auxiliary to transport services Sector \u2013 sub-sector: Transport services - auxiliary services for water transport, auxiliary services to rail transport, services auxiliary to road transport, services auxiliary to air transport services Industry classification: CPC 711, 712, 721, 741, 742, 743, 744, 745, 746, 748, 749 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: (a) Services auxiliary to air transport services (CPC 746) With respect to Investment liberalisation - Market access and Cross-border trade in services - Market access: The level of openness of groundhandling services depends on the size of airport. The number of suppliers in each airport may be limited. For \"big airports\", this limit may not be less than two suppliers. Measures: The Airports (Groundhandling) Regulations 1997 (S.I. 1997/2389) (b) Supporting services for all modes of transport With respect to Investment liberalisation - National treatment and Cross-border trade in services - Market access, Local presence, National treatment: Customs services, including customs clearance services and services relating to use of temporary storage facilities or customs warehouses, may only be provided by persons established in the UK. For the avoidance of doubt, this includes UK residents, persons with a permanent place of business in the UK or a registered office in the UK. Measures: Taxation (Cross-Border Trade Act) 2018; the Customs and Excise Management Act 1979; the Customs (Export) (EU Exit) Regulations 2019; the Customs (Import Duty) (EU Exit) Regulations 2018; the Customs (Special Procedures and Outward Processing) (EU Exit) Regulations 2018; the Customs and Excise (Miscellaneous Provisions and Amendments) (EU Exit) Regulations 2019/1215. (c) Auxiliary services for water transport With respect to Investment liberalisation \u2013 Market access, and Cross-border trade in Services \u2013 Market access: For port services, the managing body of a port, or the competent authority, may limit the number of providers of port services for a given port service. Measures: Regulation (EU) 2017/352 of 15 February 2017 establishing a framework for the provision of port services and common rules on the financial transparency of ports, Article 6 as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Pilotage and Port Services (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/671) Port Services Regulations 2019 Reservation No. 8 \u2013 Energy related activities Sector \u2013 sub-sector: Energy related activities - mining and quarrying Industry classification: ISIC Rev. 3.1 11, 8675, 883 Type of reservation: Market access Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: A licence is necessary to undertake exploration and production activities on the UK Continental Shelf (UKCS), and to provide services which require direct access to or exploitation of natural resources. This reservation applies to production licences issued with respect to the UK Continental Shelf. To be a Licensee, a company must have a place of business within the UK. That means either: (i) a staffed presence in the UK; (ii) registration of a UK company at Companies House; or (iii) registration of a UK branch of a foreign company at Companies House. This requirement exists for any company applying for a new licence and for any company seeking to join an existing licence by assignment. It applies to all licences and to all enterprises, whether operator or not. To be a party to a licence that covers a producing field, a company must: (a) be registered at Companies House as a UK company; or (b) carry on its business through a fixed place of business in the UK as defined in section 148 of the Finance Act 2003 (which normally requires a staffed presence) (ISIC Rev. 3.1 11, CPC 883, 8675). Measures: Petroleum Act 1998 (1) For the purposes of this reservation: (a) \"host-jurisdiction law\" means the law of the specific Member State and Union law; \"home-jurisdiction law\" means the law of the United Kingdom; (b) \"international law\" means public international law with the exception of European Union law, and includes law established by international treaties and conventions, as well as international customary law; (c) \"legal advisory services\" includes provision of advice to and consultation with clients in matters, including transactions, relationships and disputes, involving the application or interpretation of law; participation with or on behalf of clients in negotiations and other dealings with third parties in such matters; and preparation of documents governed in whole or in part by law, and the verification of documents of any kind for purposes of and in accordance with the requirements of law; (d) \"legal representational services\" includes preparation of documents intended to be submitted to administrative agencies, the courts or other duly constituted official tribunals; and appearance before administrative agencies, the courts or other duly constituted official tribunals; (e) \"legal arbitration, conciliation and mediation services\" means the preparation of documents to be submitted to, the preparation for and appearance before, an arbitrator, conciliator or mediator in any dispute involving the application and interpretation of law. It does not include arbitration, conciliation and mediation services in disputes not involving the application and interpretation of law, which fall under services incidental to management consulting. It also does not include acting as an arbitrator, conciliator or mediator. As a sub-category, international legal arbitration, conciliation or mediation services refers to the same services when the dispute involves parties from two or more countries. (2) Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ EU L 154, 16.6.2017, p. 1). (3) Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (OJ EU L 3, 5.1.2002, p. 1). (4) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ EU L 182, 29.6.2013, p. 19). (5) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ EU L 157, 9.6.2006, p. 87). (6) Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community (OJ EU L 293 31.10.2008, p. 3). (7) Regulation (EC) No 80/2009 of the European Parliament and of the Council of 14 January 2009 on a Code of Conduct for computerised reservation systems and repealing Council Regulation (EEC) No 2299/89 (OJ EU L 35, 4.2.2009, p. 47). (8) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ EU L 15 21.1.1998, p. 14). (9) Regulation (EU) No 909/2014 of the European Parliament and of the Council of 23 July 2014 on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012 (OJ EU L 257 28.8.2014, p. 1). (10) Regulation (EU) 2017/352 of the European Parliament and of the Council of 15 February 2017 establishing a framework for the provision of port services and common rules on the financial transparency of ports (OJ EU L 57 3.3.2017, p. 1). (11) Council Directive 96/67/EC of 15 October 1996 on access to the groundhandling market at Community airports (OJ EU L 272, 25.10.1996, p. 36). (12) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ EU L 269, 10.10.2013, p. 1). ANNEX 20 FUTURE MEASURES Headnotes 1. The Schedules of the United Kingdom and the Union set out, under Articles 133, 139 and 195 of this Agreement, the reservations taken by the United Kingdom and the Union with respect to existing measures that do not conform with obligations imposed by: (a) Article 128 or 135 of this Agreement; (b) Article 136 of this Agreement; (c) Article 129 or 137 of this Agreement; (d) Article 130 or 138 of this Agreement; (e) Article 131 of this Agreement; (f) Article 132 of this Agreement; (g) Article 194 of this Agreement. 2. The reservations of a Party are without prejudice to the rights and obligations of the Parties under GATS. 3. Each reservation sets out the following elements: (a) \"sector\" refers to the general sector in which the reservation is taken; (b) \"sub-sector\" refers to the specific sector in which the reservation is taken; (c) \"industry classification\" refers, where applicable, to the activity covered by the reservation according to the CPC, ISIC rev 3.1, or as expressly otherwise described in a Party's reservation; (d) \"type of reservation\" specifies the obligation referred to in paragraph 1 for which a reservation is taken; (e) \"description\" sets out the scope of the sector, sub-sector or activities covered by the reservation; and (f) \"existing measures\" identifies, for transparency purposes, existing measures that apply to the sector, sub-sector or activities covered by the reservation. 4. In the interpretation of a reservation, all elements of the reservation shall be considered. The \"description\" element shall prevail over all other elements. 5. For the purposes of the Schedules of the United Kingdom and the European Union: (a) \"ISIC Rev. 3.1\" means the International Standard Industrial Classification of All Economic Activities as set out in Statistical Office of the United Nations, Statistical Papers, Series M, No.4, ISIC Rev. 3.1, 2002; (b) \"CPC\" means the Provisional Central Product Classification (Statistical Papers, Series M No. 77, Department of International Economic and Social Affairs, Statistical Office of the United Nations, New York,1991). 6. For the purposes of the Schedules of the United Kingdom and the Union, a reservation for a requirement to have a local presence in the territory of the Union or the United Kingdom is taken against Article 136 of this Agreement, and not against Article 135 or 137 of this Agreement. Furthermore, such a requirement is not taken as a reservation against Article 129 of this Agreement. 7. A reservation taken at the level of the Union applies to a measure of the Union, to a measure of a Member State at the central level or to a measure of a government within a Member State, unless the reservation excludes a Member State. A reservation taken by a Member State applies to a measure of a government at the central, regional or local level within that Member State. For the purposes of the reservations of Belgium, the central level of government covers the federal government and the governments of the regions and the communities as each of them holds equipollent legislative powers. For the purposes of the reservations of the Union and its Member States, a regional level of government in Finland means the \u00c5land Islands. A reservation taken at the level of the United Kingdom applies to a measure of the central government, a regional government or a local government. 8. The list of reservations below does not include measures relating to qualification requirements and procedures, technical standards and licensing requirements and procedures where they do not constitute a market access or a national treatment limitation within the meaning of Article 128, 129, 135, 136, 137 or 194 of this Agreement. These measures may include, in particular the need to obtain a licence, to satisfy universal service obligations, to have recognised qualifications in regulated sectors, to pass specific examinations, including language examinations, to fulfil a membership requirement of a particular profession, such as membership in a professional organisation, to have a local agent for service, or to maintain a local address, or any other non-discriminatory requirements that certain activities may not be carried out in protected zones or areas. While not listed, such measures continue to apply. 9. For greater certainty, for the Union, the obligation to grant national treatment does not entail the requirement to extend to natural or legal persons of the United Kingdom the treatment granted in a Member State, pursuant to the Treaty on the Functioning of the European Union, or any measure adopted pursuant to that Treaty, including their implementation in the Member States, to: (a) natural persons or residents of another Member State; or (b) legal persons constituted or organised under the law of another Member State or of the Union and having their registered office, central administration or principal place of business in the Union. 10. Treatment granted to legal persons established by investors of a Party in accordance with the law of the other Party (including, in the case of the Union, the law of a Member State) and having their registered office, central administration or principal place of business within that other Party, is without prejudice to any condition or obligation, consistent with Chapter 2 of Title II of Heading One of Part Two of this Agreement, which may have been imposed on such legal person when it was established in that other Party, and which shall continue to apply. 11. The Schedules apply only to the territories of the United Kingdom and the European Union in accordance with Article 520(2) and Article 774 of this Agreement and are only relevant in the context of trade relations between the Union and its Member States with the United Kingdom. They do not affect the rights and obligations of the Member States under Union law. 12. For greater certainty, non-discriminatory measures do not constitute a market access limitation within the meaning of Article 128, 135 or 194 of this Agreement for any measure: (a) requiring the separation of the ownership of infrastructure from the ownership of the goods or services provided through that infrastructure to ensure fair competition, for example in the fields of energy, transportation and telecommunications; (b) restricting the concentration of ownership to ensure fair competition; (c) seeking to ensure the conservation and protection of natural resources and the environment, including a limitation on the availability, number and scope of concessions granted, and the imposition of a moratorium or ban; (d) limiting the number of authorisations granted because of technical or physical constraints, for example telecommunications spectra and frequencies; or (e) requiring that a certain percentage of the shareholders, owners, partners, or directors of an enterprise be qualified or practice a certain profession such as lawyers or accountants. 13. With respect to financial services: Unlike foreign subsidiaries, branches established directly in a Member State by a non-European Union financial institution are not, with certain limited exceptions, subject to prudential regulations harmonised at European Union level which enable such subsidiaries to benefit from enhanced facilities to set up new establishments and to provide cross-border services throughout the Union. Therefore, such branches receive an authorisation to operate in the territory of a Member State under conditions equivalent to those applied to domestic financial institutions of that Member State, and may be required to satisfy a number of specific prudential requirements such as, in the case of banking and securities, separate capitalisation and other solvency requirements and reporting and publication of accounts requirements or, in the case of insurance, specific guarantee and deposit requirements, a separate capitalisation, and the localisation in the Member State concerned of the assets representing the technical reserves and at least one third of the solvency margin. The following abbreviations are used in the list of reservations below: UK United Kingdom EU European Union, including all its Member States AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czechia DE Germany DK Denmark EE Estonia EL Greece ES Spain FI Finland FR France HR Croatia HU Hungary IE Ireland IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta NL The Netherlands PL Poland PT Portugal RO Romania SE Sweden SI Slovenia SK Slovak Republic Schedule of the Union Reservation No. 1 - All sectors Reservation No. 2 - Professional services \u2013 other than health related services Reservation No. 3 - Professional services \u2013 health related and retail of pharmaceuticals Reservation No. 4 - Business Services - Research and development services Reservation No. 5 - Business Services - Real estate services Reservation No. 6 - Business services - Rental or leasing services Reservation No. 7 - Business Services - Collection agency services and Credit reporting services Reservation No. 8 - Business Services - Placement services Reservation No. 9 - Business Services - Security and investigation services Reservation No. 10 - Business Services - Other business services Reservation No. 11 - Telecommunication Reservation No. 12 - Construction Reservation No. 13 - Distribution services Reservation No. 14 - Education services Reservation No. 15 - Environmental services Reservation No. 16 \u2013 Financial Services Reservation No. 17 - Health services and social services Reservation No. 18 - Tourism and travel related services Reservation No. 19 - Recreational, cultural and sporting services Reservation No. 20 - Transport services and auxiliary transport services Reservation No. 21 - Agriculture, fishing and water Reservation No. 22 - Energy related activities Reservation No. 23 - Other services not included elsewhere Reservation No. 1 - All sectors Sector: All sectors Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Obligations for legal services Chapter/Section: Investment liberalisation, Cross-border trade in services and Regulatory framework for legal services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Establishment With respect to Investment liberalisation \u2013 Market access: The EU: Services considered as public utilities at a national or local level may be subject to public monopolies or to exclusive rights granted to private operators. Public utilities exist in sectors such as related scientific and technical consulting services, research and development (R&D) services on social sciences and humanities, technical testing and analysis services, environmental services, health services, transport services and services auxiliary to all modes of transport. Exclusive rights on such services are often granted to private operators, for instance operators with concessions from public authorities, subject to specific service obligations. Given that public utilities often also exist at the sub-central level, detailed and exhaustive sector-specific scheduling is not practical. This reservation does not apply to telecommunications and to computer and related services. With respect to Investment liberalisation \u2013 Market access, National treatment; Cross-border trade in services \u2013 Market access, National treatment and Regulatory framework for legal services \u2013 Obligations: In FI: Restrictions on the right for natural persons, who do not enjoy regional citizenship in \u00c5land, and for legal persons, to acquire and hold real property on the \u00c5land Islands without obtaining permission from the competent authorities of the \u00c5land Islands. Restrictions on the right of establishment and right to carry out economic activities by natural persons, who do not enjoy regional citizenship in \u00c5land, or by any enterprise, without obtaining permission from the competent authorities of the \u00c5land Islands. Existing measures: FI: Ahvenanmaan maanhankintalaki (Act on land acquisition in \u00c5land) (3/1975), s. 2; and Ahvenanmaan itsehallintolaki (Act on the Autonomy of \u00c5land) (1144/1991), s. 11. With respect to Investment liberalisation \u2013 Market access, National treatment, Performance requirements, Senior management and boards of directors; Regulatory Framework for legal services \u2013 Obligations: In FR: Pursuant to articles L151-1 and 151-1 et seq of the financial and monetary code, foreign investments in France in sectors listed in article R.151-3 of the financial and monetary code are subject to prior approval from the Minister for the Economy. Existing measures: FR: As set out in the description element as indicated above. With respect to Investment liberalisation \u2013 National treatment, Senior management and boards of directors: In FR: Limiting foreign participation in newly privatised companies to a variable amount, determined by the government of France on a case by case basis, of the equity offered to the public. For establishing in certain commercial, industrial or artisanal activities, a specific authorisation is needed if the managing director is not a holder of a permanent residence permit. With respect to Investment liberalisation \u2013 Market access and Regulatory framework for legal services \u2013 Obligations: In HU: Establishment should take a form of limited liability company, joint-stock company or representative office. Initial entry as a branch is not permitted except for financial services. With respect to Investment liberalisation \u2013 Market access, National treatment: In BG: Certain economic activities related to the exploitation or use of State or public property are subject to concessions granted under the provisions of the Concessions Act. In commercial corporations in which the State or a municipality holds a share in the capital exceeding 50 per cent, any transactions for disposition of fixed assets of the corporation, to conclude any contracts for acquisition of participating interest, lease, joint activity, credit, securing of receivables, as well as incurring any obligations arising under bills of exchange, are subject to authorisation or permission by the Privatisation Agency or other state or regional bodies, whichever is the competent authority. This reservation does not apply to mining and quarrying, which are subject to a separate reservation in the Schedule of the Union in Annex 19 to this Agreement. In IT: The Government may exercise certain special powers in enterprises operating in the areas of defence and national security, and in certain activities of strategic importance in the areas of energy, transport and communications. This applies to all juridical persons carrying out activities considered of strategic importance in the areas of defence and national security, not only to privatised companies. If there is a threat of serious injury to the essential interests of defence and national security, the Government has following special powers to: (a) to impose specific conditions in the purchase of shares; (b) to veto the adoption of resolutions relating to special operations such as transfers, mergers, splitting up and changes of activity; or (c) to reject the acquisition of shares, where the buyer seeks to hold a level of participation in the capital that is likely to prejudice the interests of defence and national security. Any resolution, act or transaction (such as transfers, mergers, splitting up, change of activity or termination) relating to strategic assets in the areas of energy, transport and communications shall be notified by the concerned company to the Prime Minister's office. In particular, acquisitions by any natural or juridical person outside the European Union that give this person control over the company shall be notified. The Prime Minister may exercise the following special powers: (a) to veto any resolution, act and transaction that constitutes an exceptional threat of serious injury to the public interest in the security and operation of networks and supplies; (b) to impose specific conditions in order to guarantee the public interest; or (c) to reject an acquisition in exceptional cases of risk to the essential interests of the State. The criteria on which to evaluate the real or exceptional threat and conditions and procedures for the exercise of the special powers are laid down in the law. Existing measures: IT: Law 56/2012 on special powers in companies operating in the field of defence and national security, energy, transport and communications; and Decree of the Prime Minister DPCM 253 of 30.11.2012 defining the activities of strategic importance in the field of defence and national security. With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment, Performance requirements, Senior management and boards of directors: In LT: Enterprises, sectors and facilities of strategic importance to national security. Existing measures: LT: Law on the Protection of Objects of Importance to Ensuring National Security of the Republic of Lithuania of 10 October 2002 No. IX-1132 (as last amended on 12 of January 2018 No XIII-992). With respect to Investment liberalisation \u2013 National treatment and Senior management and boards of directors: In SE: Discriminatory requirements for founders, senior management and boards of directors when new forms of legal association are incorporated into Swedish law. (b) Acquisition of real estate With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors: In HU: The acquisition of state-owned properties. With respect to Investment liberalisation \u2013 Market access, National treatment: In HU: The acquisition of arable land by foreign legal persons and non-resident natural persons. Existing measures: HU: Act CXXII of 2013 on the circulation of agricultural and forestry land (Chapter II (Paragraph 6-36) and Chapter IV (Paragraph 38-59)); and Act CCXII of 2013 on the transitional measures and certain provisions related to Act CXXII of 2013 on the circulation of agricultural and forestry land (Chapter IV (Paragraph 8-20)). In LV: The acquisition of rural land by nationals of the United Kingdom or of a third country. Existing measures: LV: Law on land privatisation in rural areas, ss. 28, 29, 30. In SK: Foreign companies or natural persons may not acquire agricultural and forest land outside the borders of the built-up area of a municipality and some other land (e.g. natural resources, lakes, rivers, public roads etc.). Existing measures: SK: Act No 44/1988 on protection and exploitation of natural resources; Act No 229/1991 on regulation of the ownership of land and other agricultural property; Act No 460/1992 Constitution of the Slovak Republic; Act No 180/1995 on some measures for land ownership arrangements; Act No 202/1995 on Foreign Exchange; Act No 503/2003 on restitution of ownership to land; Act No 326/2005 on Forests; and Act No 140/2014 on the acquisition of ownership of agricultural land. With respect to Investment liberalisation \u2013 National treatment and Cross-border trade in services \u2013 Local presence: In BG: Foreign natural and legal persons cannot acquire land. Legal persons of Bulgaria with foreign participation cannot acquire agricultural land. Foreign legal persons and foreign natural persons with permanent residence abroad can acquire buildings and real estate property rights (right to use, right to build, right to raise a superstructure and servitudes). Foreign natural persons with permanent residence abroad, foreign legal persons in which foreign participation ensures a majority in adopting decisions or blocks the adoption of decisions, can acquire real estate property rights in specific geographic regions designated by the Council of Ministers subject to permission. BG: Constitution of the Republic of Bulgaria, article 22; Law on Ownership and Use of Agricultural Land, article 3; and Law on Forests, article 10. In EE: Foreign natural or legal persons that are not from the EEA or from members of the Organisation for Economic Co-operation and Development can acquire an immovable asset which contains agricultural and/or forest land only with the authorisation of the county governor and of the municipal council, and must prove as prescribed by law that the immovable asset will, according to its intended purpose, be used efficiently, sustainably and purposefully. Existing measures: EE: Kinnisasja omandamise kitsendamise seadus (Restrictions on Acquisition of Immovables Act) Chapters 2 and 3. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services - Market access, National treatment: In LT: Any measure which is consistent with the commitments taken by the European Union and which are applicable in Lithuania in GATS with respect to land acquisition. The land plot acquisition procedure, terms and conditions, as well as restrictions shall be established by the Constitutional Law, the Law on Land and the Law on the Acquisition of Agricultural Land. However, local governments (municipalities) and other national entities of Members of the Organisation for Economic Co-operation and Development and North Atlantic Treaty Organization conducting economic activities in Lithuania, which are specified by the constitutional law in compliance with the criteria of European Union and other integration which Lithuania has embarked on, are permitted to acquire into their ownership non-agricultural land plots required for the construction and operation of buildings and facilities necessary for their direct activities. Existing measures: LT: Constitution of the Republic of Lithuania; The Constitutional Law of the Republic of Lithuania on the Implementation of Paragraph 3 of Article 47 of the Constitution of the Republic of Lithuania of 20 June 1996, No. I-1392 as last amended 20 March 2003, No. IX-1381; Law on land, of 27 January 2004, No. IX-1983; and Law on acquisition of agricultural land of 24 April 2014, No. XII-854. (c) Recognition With respect to Investment liberalisation \u2013National treatment and Cross-border trade in services \u2013 National treatment: In EU: The Union directives on mutual recognition of diplomas and other professional qualification only apply to the citizens of the Union. The right to practise a regulated professional service in one Member State does not grant the right to practise in another Member State. (d) Most-favoured-nation treatment With respect to Investment liberalisation \u2013 Most-favoured-nation treatment and Cross-border trade in services \u2013 Most-favoured-nation treatment and Regulatory framework for legal services \u2013 Obligations: The EU: According differential treatment to a third country pursuant to any international investment treaties or other trade agreement in force or signed prior to the date of entry into force of this Agreement. The EU: According differential treatment to a third country pursuant to any existing or future bilateral or multilateral agreement which: (i) creates an internal market in services and investment; (ii) grants the right of establishment; or (iii) requires the approximation of legislation in one or more economic sectors. An internal market in services and investment means an area without internal frontiers in which the free movement of services, capital and persons is ensured. The right of establishment means an obligation to abolish in substance all barriers to establishment among the parties to the bilateral or multilateral agreement by the entry into force of that agreement. The right of establishment shall include the right of nationals of the parties to the bilateral or multilateral agreement to set up and operate enterprises under the same conditions provided for nationals under the law of the party where such establishment takes place. The approximation of legislation means: (i) the alignment of the legislation of one or more of the parties to the bilateral or multilateral agreement with the legislation of the other party or parties to that agreement; or (ii) the incorporation of common legislation into the law of the parties to the bilateral or multilateral agreement. Such alignment or incorporation shall take place, and shall be deemed to have taken place, only at such time that it has been enacted in the law of the party or parties to the bilateral or multilateral agreement. Existing measures: EU: Agreement on the European Economic Area; Stabilisation Agreements; EU-Swiss Confederation bilateral agreements; and Deep and Comprehensive Free Trade Agreements. The EU: According differential treatment relating to the right of establishment to nationals or enterprises through existing or future bilateral agreements between the following Member States: BE, DE, DK, EL, ES, FR, IE, IT, LU, NL, PT and any of the following countries or principalities: Andorra, Monaco, San Marino and the Vatican City State. In DK, FI, SE: Measures taken by Denmark, Sweden and Finland aimed at promoting Nordic cooperation, such as: (a) financial support to research and development (R&D) projects (the Nordic Industrial Fund); (b) funding of feasibility studies for international projects (the Nordic Fund for Project Exports); and (c) financial assistance to companies utilizing environmental technology (the Nordic Environment Finance Corporation). The purpose of the Nordic Environment Finance Corporation (NEFCO) is to promote investments of Nordic environmental interest, with a focus on Eastern Europe. This reservation is without prejudice to the exclusion of procurement by a Party or subsidies in Article 123(6) and (7) of this Agreement. In PL: Preferential conditions for establishment or the cross-border supply of services, which may include the elimination or amendment of certain restrictions embodied in the list of reservations applicable in Poland, may be extended through commerce and navigation treaties. In PT: Waiving nationality requirements for the exercise of certain activities and professions by natural persons supplying services for countries in which Portuguese is the official language (Angola, Brazil, Cape Verde, Guinea-Bissau, Equatorial Guinea, Mozambique, S\u00e3o Tom\u00e9 & Principe, and East Timor). (e) Arms, munition and war material With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment, Most-favoured-nation treatment, Local presence: In EU: Production or distribution of, or trade in, arms, munitions and war material. War material is limited to any product which is solely intended and made for military use in connection with the conduct of war or defence activities. Reservation No. 2 - Professional services - other than health related services Sector: Professional services - legal services: services of notaries and by bailiffs; accounting and bookkeeping services; auditing services, taxation advisory services; architecture and urban planning services, engineering services, and integrated engineering services Industry classification: Part of CPC 861, part of 87902, 862, 863, 8671, 8672, 8673, 8674, part of 879 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Legal services With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment: The EU, with the exception of SE: The supply of legal advisory and legal authorisation, documentation, and certification services provided by legal professionals entrusted with public functions, such as notaries, \"huissiers de justice\" or other \"officiers publics et minist\u00e9riels\", and with respect to services provided by bailiffs who are appointed by an official act of government (part of CPC 861, part of 87902). With respect to Investment liberalisation \u2013 Most-favoured-nation treatment and Cross-border trade in services \u2013 Most-favoured-nation treatment: In BG: Full national treatment on the establishment and operation of companies, as well as on the supply of services, may be extended only to companies established in, and citizens of, the countries with whom preferential arrangements have been or will be concluded (part of CPC 861). In LT: Attorneys from foreign countries can participate as advocates in court only in accordance with international agreements (part of CPC 861), including specific provisions regarding representation before courts. (b) Accounting and bookkeeping services (CPC 8621 other than auditing services, 86213, 86219, 86220) With respect to Cross-border trade in services \u2013 Market access: In HU: Cross-border activities for accounting and bookkeeping. Existing measures: HU: Act C of 2000; and Act LXXV of 2007. (c) Auditing services (CPC \u2013 86211, 86212 other than accounting and bookkeeping services) With respect to Cross-border trade in services - National treatment: In BG: An independent financial audit shall be implemented by registered auditors who are members of the Institute of the Certified Public Accountants. Subject to reciprocity, the Institute of the Certified Public Accountants shall register an audit entity of the United Kingdom or of a third country upon the latter furnishing proof that: (a) three-fourths of the members of the management bodies and the registered auditors carrying out audit on behalf of the entity meet requirements equivalent to those for Bulgarian auditors and have passed successfully the examinations for it; (b) the audit entity carries out independent financial audit in accordance with the requirements for independence and objectivity; and (c) the audit entity publishes on its website an annual transparency report or performs other equivalent requirements for disclosure in case it audits public-interest entities. Existing Measures: BG: Independent Financial Audit Act. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors: In CZ: Only a legal person in which at least 60 per cent of capital interests or voting rights are reserved to nationals of the Czech Republic or of the Member States of the European Union is authorised to carry out audits in the Czech Republic. Existing Measures: CZ: Law of 14 April 2009 no. 93/2009 Coll., on Auditors. With respect to Cross-border trade in services \u2013 Market access: In HU: Cross-border supply of auditing services. Existing Measures: HU: Act C of 2000; and Act LXXV of 2007. In PT: Cross-border supply of auditing services. (d) Architecture and urban planning services (CPC 8674) With respect to Cross-border trade in services \u2013 Market access, National treatment: In HR: The cross-border supply of urban planning. Reservation No. 3 - Professional services \u2013 health related and retail of pharmaceuticals Sector: Health related professional services and retail sales of pharmaceutical, medical and orthopaedic goods, other services provided by pharmacists Industry classification: CPC 63211, 85201, 9312, 9319, 93121 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Medical and dental services; services provided by midwives, nurses, physiotherapists, psychologists and paramedical personnel (CPC 63211, 85201, 9312, 9319, CPC 932) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access and National treatment: In FI: The supply of all health-related professional services, whether publicly or privately funded, including medical and dental services, services provided by midwives, physiotherapists and paramedical personnel and services provided by psychologists, excluding services provided by nurses (CPC 9312, 93191). Existing measures: FI: Laki yksityisest\u00e4 terveydenhuollosta (Act on Private Health Care) (152/1990). In BG: The supply of all health-related professional services, whether publicly or privately funded, including medical and dental services, services provided by nurses, midwives, physiotherapists and paramedical personnel and services provided by psychologists (CPC 9312, part of 9319). Existing Measures: BG: Law for Medical Establishment, Professional Organisation of Medical Nurses, Midwives and Associated Medical Specialists Guild Act. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access and National treatment: In CZ, MT: The supply of all health-related professional services, whether publicly or privately funded, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, psychologists, as well as other related services (CPC 9312, part of 9319). Existing Measures: CZ: Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man (\"Act on Human Tissues and Cells\"); Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals); Act No. 268/2014 Coll. on medical devices and amending Act No 634/2004 Coll. on administrative fees, as subsequently amended; Act No. 285/2002 Coll., on the Donating, Taking and Transplanting of Tissues and Organs and on Amendment to Certain Acts (Transplantation Act). Act No. 372/2011 Coll., on health services and on conditions of their provision Act No. 373/2011 Coll., on specific health services). With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU, with the exception of NL and SE: The supply of all health-related professional services, whether publicly or privately funded, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, requires residency. These services may only be provided by natural persons physically present in the territory of the European Union (CPC 9312, part of 93191). In BE: The cross-border supply whether publicly or privately funded of all health-related professional services, including medical, dental and midwives services and services provided by nurses, physiotherapists, psychologists and paramedical personnel. (part of CPC 85201, 9312, part of 93191). In PT: (Also with respect to Most-favoured nation treatment) Concerning the professions of physiotherapists, paramedical personnel and podiatrists, foreign professionals may be allowed to practice based on reciprocity. (b) Veterinary services (CPC 932) With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013National treatment, Local presence: In BG: A veterinary medical establishment may be established by a natural or a legal person. The practice of veterinary medicine is only allowed for nationals of the EEA and for permanent residents (physical presence is required for permanent residents). With respect to Cross-border trade in services \u2013 Market access, National treatment: In BE, LV: Cross-border supply of veterinary services. (c) Retail sales of pharmaceutical, medical and orthopaedic goods, other services provided by pharmacists (CPC 63211) With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Local presence: The EU, with the exception of EL, IE, LU, LT and NL: For restricting the number of suppliers entitled to provide a particular service in a specific local zone or area on a non-discriminatory basis. An economic needs test may therefore be applied, taking into account such factors as the number of and impact on existing establishments, transport infrastructure, population density or geographic spread. The EU, with the exception of BE, BG, EE, ES, IE and IT: Mail order is only possible from Member States of the EEA, thus establishment in any of those countries is required for the retail of pharmaceuticals and specific medical goods to the general public in the Union. In CZ: Retail sales are only possible from Member States. In BE: The retail sales of pharmaceuticals and specific medical goods are only possible from a pharmacy established in Belgium. In BG, EE, ES, IT and LT: Cross-border retail sales of pharmaceuticals. In IE and LT: Cross-border retail of pharmaceuticals requiring a prescription. In PL: Intermediaries in the trade of medicinal products must be registered and have a place of residence or registered office in the territory of the Republic of Poland. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment: In FI: Retail sales of pharmaceutical products and of medical and orthopaedic goods. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment: In SE: Retail sales of pharmaceutical goods and the supply of pharmaceutical goods to the general public. Existing measures: AT: Arzneimittelgesetz (Medication Act), BGBl. Nr. 185/1983 as amended, \u00a7\u00a7 57, 59, 59a; and Medizinproduktegesetz (Medical Products Law), BGBl. Nr. 657/1996 as amended, \u00a7 99. BE: Arr\u00eat\u00e9 royal du 21 janvier 2009 portant instructions pour les pharmaciens; and Arr\u00eat\u00e9 royal du 10 novembre 1967 relatif \u00e0 l'exercice des professions des soins de sant\u00e9. CZ: Act No. 378/2007 Coll., on Pharmaceuticals, as amended; and Act No. 372/2011 Coll., on Health services, as amended. FI: L\u00e4\u00e4kelaki (Medicine Act) (395/1987). PL: Pharmaceutical Law, art. 73a (Journal of Laws of 2020, item 944, 1493). SE: Law on trade with pharmaceuticals (2009:336); Regulation on trade with pharmaceuticals (2009:659); and The Swedish Medical Products Agency has adopted further regulations, the details can be found at (LVFS 2009:9). Reservation No. 4 - Business Services - Research and development services Sector: Research and development services Industry classification: CPC 851, 852, 853 Type of reservation: Market access National treatment Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In RO: Cross-border supply of research and development services. Existing measures: RO: Governmental Ordinance no. 6 / 2011; Order of Minister of Education and Research no. 3548 / 2006; and Governmental Decision no. 134 / 2011. Reservation No. 5 - Business Services - Real estate services Sector: Real estate services Industry classification: CPC 821, 822 Type of reservation: Market access National treatment Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In CZ and HU: Cross-border supply of real estate services. Reservation No. 6 - Business services - Rental or leasing services Sector: Rental or leasing services without operators Industry classification: CPC 832 Type of reservation: Market access National treatment Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In BE and FR: Cross-border supply of leasing or rental services without operator concerning personal and household goods. Reservation No. 7 - Business Services - Collection agency services and Credit reporting services Sector: Collection agency services, credit reporting services Industry classification: CPC 87901, 87902 Type of reservation: Market access National treatment Local presence Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: The EU, with the exception of ES, LV and SE, with regard to the supply of collection agency services and credit reporting services. Reservation No. 8 - Business Services - Placement services Sector \u2013 sub-sector: Business Services \u2013 placement services Industry classification: CPC 87201, 87202, 87203, 87204, 87205, 87206, 87209 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In the EU, with the exception of HU and SE: Supply services of domestic help personnel, other commercial or industrial workers, nursing and other personnel (CPC 87204, 87205, 87206, 87209). In BG, CY, CZ, DE, EE, FI, MT, LT, LV, PL, PT, RO, SI and SK: Executive search services (CPC 87201). In AT, BG, CY, CZ, EE, FI, LT, LV MT, PL, PT, RO, SI and SK: The establishment of placement services of office support personnel and other workers (CPC 87202). In AT, BG, CY, CZ, DE, EE, FI, MT, LT, LV, PL, PT, RO, SI and SK: Supply services of office support personnel (CPC 87203). With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: In the EU with the exception of BE, HU and SE: The cross-border supply of placement services of office support personnel and other workers (CPC 87202). In IE: The cross-border supply of executive search services (CPC 87201). In FR, IE, IT and NL: The cross-border supply of services of office personnel (CPC 87203). With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access In DE : To restrict the number of suppliers of placement services. In ES: To restrict the number of suppliers of executive search services and placement services (CPC 87201, 87202). In FR: These services can be subject to a state monopoly (CPC 87202). In IT: To restrict the number of suppliers of supply services of office personnel (CPC 87203). With respect to Investment liberalisation \u2013Market access, National treatment: In DE: The Federal Ministry of Labour and Social Affairs may issue a regulation concerning the placement and recruitment of non-European Union and non-EEA personnel for specified professions (CPC 87201, 87202, 87203, 87204, 87205, 87206, 87209). Existing measures: AT: \u00a7\u00a797 and 135 of the Austrian Trade Act (Gewerbeordnung), Federal Law Gazette Nr. 194/1994 as amended; and Temporary Employment Act (Arbeitskr\u00e4fte\u00fcberlassungsgesetz/A\u00dcG), Federal Law Gazette Nr. 196/1988 as amended. BG: Employment Promotion Act, articles 26, 27, 27a and 28. CY: Private Employment Agency Law N. 126(I)/2012 as amended. CZ: Act on Employment (435/2004). DE: Gesetz zur Regelung der Arbeitnehmer\u00fcberlassung (A\u00dcG); Sozialgesetzbuch Drittes Buch (SGB III; Social Code, Book Three) - Employment Promotion; Verordnung \u00fcber die Besch\u00e4ftigung von Ausl\u00e4nderinnen und Ausl\u00e4ndern (BeschV; Ordinance on the Employment of Foreigners). DK: \u00a7\u00a7 8a \u2013 8f in law decree no. 73 of 17th of January 2014 and specified in decree no. 228 of 7th of March 2013 (employment of seafarers); and Employment Permits Act 2006. S1(2) and (3). EL: Law 4052/2012 (Official Government Gazette 41 \u0391) as amended to some of its provision by the law \u039d.4093/2012 (Official Government Gazette 222 \u0391). ES: Real Decreto-ley 8/2014, de 4 de julio, de aprobaci\u00f3n de medidas urgentes para el crecimiento, la competitividad y la eficiencia, art\u00edculo 117 (tramitado como Ley 18/2014, de 15 de octubre). FI: Laki julkisesta ty\u00f6voima-ja yrityspalvelusta (Act on Public Employment and Enterprise Service) (916/2012). HR: Labour Market Act (OG 118/18, 32/20) Labour Act (OG 93/14, 127/17, 98/19) Aliens Act (OG 130/11m 74/13, 67/17, 46/18, 53/20) IE: Employment Permits Act 2006. S1(2) and (3). IT: Legislative Decree 276/2003 articles 4, 5. LT: Lithuanian Labour Code of the Republic of Lithuania approved by Law No XII-2603 of 14 September 2016 of the Republic of Lithuania, The Law on the Legal Status of Aliens of the Republic of Lithuania of 29 April 2004 No. IX-2206 as last amended 03-12-2019 No. XIII-2582. LU: Loi du 18 janvier 2012 portant cr\u00e9ation de l'Agence pour le d\u00e9veloppement de l'emploi (Law of 18 January 2012 concerning the creation of an agency for employment development \u2013 ADEM). MT: Employment and Training Services Act, (Cap 343) (Articles 23 to 25); and Employment Agencies Regulations (S.L. 343.24). PL: Article 18 of the Act of 20 April 2004 on the promotion of employment and labour market institutions (Dz. U. of 2015, Item. 149, as amended). PT: Decree-Law No 260/2009 of 25 September, as amended by Law No. 5/2014 of 12 February (access and provision of services by placement agencies). RO: Law no. 156/2000 on the protection of Romanian citizens working abroad, republished, and Government Decision no. 384/2001 for approving the methodological norms for applying the Law no. 156/2000, with subsequent amendments; Ordinance of the Government no. 277/2002, as modified by Government Ordinance No. 790/2004 and Government Ordinance No. 1122/2010; and Law no.53/2003 - Labour Code, republished, with subsequent amendments and supplement and the Government Decision no 1256/2011 on the operating conditions and authorization procedure for temporary work agency. SI: Labour market regulation act (Official Gazette of RS, No. 80/2010, 21/2013, 63/2013, 55/2017); and Employment, Self-employment and Work of Aliens Act \u2013 ZZSDT (Official Gazette of RS, No. 47/2015), ZZSDT-UPB2 (Official Gazette of RS, No. 1 /2018). SK: Act No 5/2004 on Employment Services; and Act No 455/1991on Trade Licensing. Reservation No. 9 - Business Services - Security and investigation services Sector\u2013 sub-sector: Business services \u2013 security and investigation services Industry classification: CPC 87301, 87302, 87303, 87304, 87305, 87309 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Security services (CPC 87302, 87303, 87304, 87305, 87309) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment: In BG, CY, CZ, EE, ES, LT, LV, MT, PL, RO, SI and SK: The supply of security services. In DK, HR and HU: The supply of the following subsectors: guard services (87305) in HR and HU, security consultation services (87302) in HR, airport guard services (part of 87305) in DK and armoured car services (87304) in HU. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013National treatment, Local presence: In BE: Nationality of a Member State is required for boards of directors of enterprises legal persons supplying guard and security services (87305) as well as consultancy and training relating to security services (87302). The senior management of companies providing guard and security consultancy services required to be resident nationals of a Member State. In FI: Licences to supply security services may be granted only to natural persons resident in the EEA or legal persons established in the EEA. In ES: The cross border supply of security services. Nationality requirements exist for private security personnel. With respect to Cross-border trade in services \u2013 Market access, National treatment: In BE, FI, FR and PT: The supply of security services by a foreign provider on a cross-border basis is not allowed. Nationality requirements exist for specialised personnel in PT and for managing directors and directors in FR. Existing measures: BE: Loi r\u00e9glementant la s\u00e9curit\u00e9 priv\u00e9e et particuli\u00e8re, 2 Octobre 2017. BG: Private Security Business Act. CZ: Trade Licensing Act. DK: Regulation on aviation security. FI: Laki yksityisist\u00e4 turvallisuuspalveluista 282/2002 (Private Security Services Act). LT: Law on security of Persons and Assets 8 July 2004 No. IX-2327. LV: Security Guard Activities Law (Sections 6, 7, 14). PL: Act of 22 August 1997 on the protection of persons and property (Journal of Laws of 2016, item 1432 as amended). PT: Law 34/2013 alterada p/ Lei 46/2019, 16 maio; and Ordinance 273/2013 alterada p/ Portaria 106/2015, 13 abril. SI: Zakon o zasebnem varovanju (Law on private security). (b) Investigation services (CPC 87301) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU, with the exception of AT and SE: The supply of investigation services. With respect to Investment liberalisation - Market access and Cross-border trade in services \u2013 Market access: In LT and PT: Investigation services are a monopoly reserved to the State. Reservation No. 10 - Business Services - Other business services Sector\u2013 sub-sector: Business services \u2013 other business services (translation and interpretation services, duplicating services, services incidental to energy distribution and services incidental to manufacturing) Industry classification: CPC 87905, 87904, 884, 887 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Translation and interpretation services (CPC 87905) With respect to Cross-border trade in services \u2013 Market access, National treatment: In HR: Cross-border supply of translation and interpretation of official documents. (b) Duplicating services (CPC 87904) With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: In HU: Cross-border supply of duplicating services. (c) Services incidental to energy distribution and services incidental to manufacturing (Part of CPC 884, 887 other than advisory and consulting services) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In HU: Services incidental to energy distribution, and cross-border supply of services incidental to manufacturing, with the exception of advisory and consulting services relating to these sectors. (d) Maintenance and repair of vessels, rail transport equipment and aircraft and parts thereof (part of CPC 86764, CPC 86769, CPC 8868) With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: In EU, with the exception of DE, EE and HU: The cross-border supply of maintenance and repair services of rail transport equipment. In EU, with the exception of CZ, EE, HU, LU and SK: Cross-border supply of maintenance and repair services of inland waterway transport vessels. In EU, with the exception of EE, HU and LV: The cross-border supply of maintenance and repair services of maritime vessels. In EU, with the exception of AT, EE, HU, LV, and PL: The cross-border supply of maintenance and repair services of aircraft and parts thereof (part of CPC 86764, CPC 86769, CPC 8868). In EU: The cross-border supply of services of statutory surveys and certification of ships. Existing measures: EU: Regulation (EC) No 391/2009 of the European Parliament and the Council (1). (e) Other business services related to aviation With respect to Investment liberalisation \u2013 Most-favoured-nation treatment and Cross-border trade in services \u2013 Most-favoured-nation treatment: The EU: According differential treatment to a third country pursuant to existing or future bilateral agreements relating to the following services: (a) the selling and marketing of air transport services; (b) computer reservation system (CRS) services; (c) maintenance and repair of aircrafts and parts, (d) rental or leasing of aircraft without crew. With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In DE, FR: Aerial fire-fighting, flight training, spraying, surveying, mapping, photography, and other airborne agricultural, industrial and inspection services. In FI, SE: Aerial fire-fighting. Reservation No. 11 - Telecommunication Sector: Satellite broadcast transmission services Industry classification: Type of reservation: Market access National treatment Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In BE: Satellite broadcast transmission services. Reservation No. 12 - Construction Sector: Construction services Industry classification: CPC 51 Type of reservation: Market access National treatment Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In LT: The right to prepare design documentation for construction works of exceptional significance is only given to a design enterprise registered in Lithuania or a foreign design enterprise which has been approved by an institution authorised by the Government for those activities. The right to perform technical activities in the main areas of construction may be granted to a non-Lithuanian person who has been approved by an institution authorised by the Government of Lithuania. Reservation No. 13 - Distribution services Sector: Distribution services Industry classification: CPC 62117, 62251, 8929, part of 62112, 62226, part of 631 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Distribution of pharmaceuticals With respect to Cross-border trade in services \u2013 Market access, National treatment: In BG: Cross-border wholesale distribution of pharmaceuticals (CPC 62251). With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services \u2013 Market access, National treatment: In FI: Distribution of pharmaceutical products (CPC 62117, 62251, 8929). Existing measures: BG: Law on Medicinal Products in Human Medicine; Law on Medical Devices. FI: L\u00e4\u00e4kelaki (Medicine Act) (395/1987). (b) Distribution of alcoholic beverages In FI: Distribution of alcoholic beverages (part of CPC 62112, 62226, 63107, 8929). Existing measures: FI: Alkoholilaki (Alcohol Act) (1102/2017). With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access: In SE: Imposing a monopoly on retail sales of liquor, wine and beer (except non-alcoholic beer). Currently Systembolaget AB has such governmental monopoly on retail sales of liquor, wine and beer (except non-alcoholic beer). Alcoholic beverages are beverages with an alcohol content over 2.25 per cent per volume. For beer, the limit is an alcohol content over 3.5 per cent per volume (part of CPC 631). Existing measures: SE: The Alcohol Act (2010:1622). (c) Other distribution (part of CPC 621, CPC 62228, CPC 62251, CPC 62271, part of CPC 62272, CPC 62276, CPC 63108, part of CPC 6329) With respect to Cross-border trade in services \u2013 Market access, National treatment: In BG: Wholesale distribution of chemical products, precious metals and stones, medical substances and products and objects for medical use; tobacco and tobacco products and alcoholic beverages. Bulgaria reserves the right to adopt or maintain any measure with respect to the services provided by commodity brokers. Existing measures: In BG: Law on Medicinal Products in Human Medicine; Law on Medical Devices; Law of Veterinary Activity; Law for Prohibition of Chemical Weapons and for Control over Toxic Chemical Substances and Their Precursors; Law for Tobacco and Tobacco Products. Law on excise duties and tax warehouses and Law on wine and spirits. Reservation No. 14 - Education services Sector: Education services Industry classification: CPC 92 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: Educational services which receive public funding or State support in any form. Where the supply of privately funded education services by a foreign provider is permitted, participation of private operators in the education system may be subject to concession allocated on a non-discriminatory basis. The EU, with the exception of CZ, NL, SE and SK: With respect to the supply of privately funded other education services, which means other than those classified as being primary, secondary, higher and adult education services (CPC 929). In CY, FI, MT and RO: The supply of privately funded primary, secondary, and adult education services (CPC 921, 922, 924). In AT, BG, CY, FI, MT and RO: The supply of privately funded higher education services (CPC 923). In CZ and SK: The majority of the members of the board of directors of an establishment providing privately funded education services must be nationals of that country (CPC 921, 922, 923 for SK other than 92310, 924). In SI: Privately funded elementary schools may be founded by Slovenian natural or legal persons only. The service supplier must establish a registered office or a branch. The majority of the members of the board of directors of an establishment providing privately funded secondary or higher education services must be Slovenian nationals (CPC 922, 923). In SE: Educational services suppliers that are approved by public authorities to provide education. This reservation applies to privately funded educational services suppliers with some form of State support, inter alia educational service suppliers recognised by the State, educational services suppliers under State supervision or education which entitles to study support (CPC 92). In SK: EEA residency is required for suppliers of all privately funded education services other than post-secondary technical and vocational education services. An economic needs test may apply and the number of schools being established may be limited by local authorities (CPC 921, 922, 923 other than 92310, 924). With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: In BG, IT and SI: To restrict the cross-border supply of privately funded primary education services (CPC 921). In BG and IT: To restrict the cross-border supply of privately funded secondary education services (CPC 922). In AT: To restrict the cross-border supply of privately funded adult education services by means of radio or television broadcasting (CPC 924). Existing measures: BG: Public Education Act, article 12; Law for the Higher Education, paragraph 4 of the additional provisions; and Vocational Education and Training Act, article 22. FI: Perusopetuslaki (Basic Education Act) (628/1998); Lukiolaki (General Upper Secondary Schools Act) (629/1998); Laki ammatillisesta koulutuksesta (Vocational Training and Education Act) (630/1998); Laki ammatillisesta aikuiskoulutuksesta (Vocational Adult Education Act) (631/1998); Ammattikorkeakoululaki (Polytechnics Act) (351/2003); and Yliopistolaki (Universities Act) (558/2009). IT: Royal Decree 1592/1933 (Law on secondary education); Law 243/1991 (Occasional public contribution for private universities); Resolution 20/2003 of CNVSU (Comitato nazionale per la valutazione del sistema universitario); and Decree of the President of the Republic (DPR) 25/1998. SK: Act 245/2008 on education; Act 131/2002 on Universities; and Act 596/2003 on State Administration in Education and School Self- Administration. Reservation No. 15 - Environmental services Sector\u2013 sub-sector: Environmental services \u2013 waste and soil management Industry classification: CPC 9401, 9402, 9403, 94060 Type of reservation: Market access Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In DE: The supply of waste management services other than advisory services, and with respect to services relating to the protection of soil and the management of contaminated soils, other than advisory services. Reservation No. 16 - Financial services Sector: Financial services Industry classification: Not applicable Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) All Financial Services With respect to Investment liberalisation \u2013 Market access The EU: the right to require a financial service supplier, other than a branch, when establishing in a Member State to adopt a specific legal form, on a non-discriminatory basis. With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence The EU: the right to adopt or maintain any measure with respect to the cross-border supply of all financial services other than: In EU (except for BE, CY, EE, LT, LV, MT, PL, RO, SI): (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (v) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In BE: (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; In CY: (i) direct insurance services (including co-insurance) for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) Insurance intermediation; (iii) Reinsurance and retrocession; (iv) Services auxiliary to insurance; (v) the trading for own account or for the account of customers, whether on an exchange or an over-the-counter market or otherwise of transferrable securities; (vi) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (vii) advisory and other auxiliary financial services, relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In EE: (i) direct insurance (including co-insurance); (ii) reinsurance and retrocession; (iii) insurance intermediation; (iv) services auxiliary to insurance; (v) acceptance of deposits; (vi) lending of all types; (vii) financial leasing; (viii) all payment and money transmission services; guarantees and commitments; (ix) trading for own account or for account of customers, whether on an exchange, in an over-the-counter market; (x) participation in issues of all kinds of securities, including underwriting and placement as agent (whether publicly or privately) and provision of services related to such issues; (xi) money broking; (xii) asset management, such as cash or portfolio management, all forms of collective investment management, custodial, depository and trust services; (xiii) settlement and clearing services for financial assets, including securities, derivative products, and other negotiable instruments; (xiv) provision and transfer of financial information, and financial data processing and related software; and (xv) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In LT: (i) direct insurance services (including co-insurance) for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) acceptance of deposits; (v) lending of all types; (vi) financial leasing; (vii) all payment and money transmission services; guarantees and commitments; (viii) trading for own account or for account of customers, whether on an exchange, in an over-the-counter market; (ix) participation in issues of all kinds of securities, including underwriting and placement as agent (whether publicly or privately) and provision of services related to such issues; (x) money broking; (xi) asset management, such as cash or portfolio management, all forms of collective investment management, custodial, depository and trust services; (xii) settlement and clearing services for financial assets, including securities, derivative products, and other negotiable instruments; (xiii) provision and transfer of financial information, and financial data processing and related software; and (xiv) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In LV: (i) direct insurance services (including co-insurance) for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) participation in issues of all kinds of securities, including underwriting and placement as agent (whether publicly or privately) and provision of services related to such issues; (v) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (vi) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In MT: (i) direct insurance services (including co-insurance) for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) the acceptance of deposits; (v) lending of all types; (vi) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (vii) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In PL: (i) direct insurance services (including co-insurance) for the insurance of risks relating to goods in international trade; (ii) reinsurance and retrocession of risks relating to goods in international trade; (iii) direct insurance services (including co-insurance and retrocession) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (iv) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (v) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In RO: (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) acceptance of deposits; (v) lending of all types; (vi) guarantees and commitments; (vii) money broking; (viii) the provision and transfer of financial information, and financial data processing and related software; and (ix) advisory and other auxiliary financial services relating to banking and other financial services as described in in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In SI: (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) lending of all types; (v) the acceptance of guarantees and commitments from foreign credit institutions by domestic legal entities and sole proprietors; (vi) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (ix) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. (b) Insurance and insurance-related services With respect to Cross-border trade in services \u2013 Market access, National treatment: In BG: Transport insurance, covering goods, insurance of vehicles as such and liability insurance regarding risks located in the Bulgaria may not be underwritten by foreign insurance companies directly. In DE: If a foreign insurance company has established a branch in Germany, it may conclude insurance contracts in Germany relating to international transport only through the branch established in Germany. Existing measures: DE: Luftverkehrsgesetz (LuftVG); and Luftverkehrszulassungsordnung (LuftVZO). With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In ES: Residence is required, or alternatively to have two years of experience, for the actuarial profession. With respect to Cross-border trade in services \u2013 Local presence: In FI: The supply of insurance broker services is subject to a permanent place of business in the EU. Only insurers having their head office in the European Union or having their branch in Finland may offer direct insurance services, including co-insurance. Existing measures: FI: Laki ulkomaisista vakuutusyhti\u00f6ist\u00e4 (Act on Foreign Insurance Companies) (398/1995); Vakuutusyhti\u00f6laki (Insurance Companies Act) (521/2008); Laki vakuutusten tarjoamisesta (Act on Insurance Distribution) (234/2018). In FR: Insurance of risks relating to ground transport may be underwritten only by insurance firms established in the European Union. Existing measures: FR: Code des assurances. In HU: Only legal persons of the EU and branches registered in Hungary may supply direct insurance services. Existing measures: HU: Act LX of 2003. In IT: Transport insurance of goods, insurance of vehicles and liability insurance regarding risks located in Italy may be underwritten only by insurance companies established in the European Union, except for international transport involving imports into Italy. Cross-border supply of actuarial services. Existing measures: IT: Article 29 of the code of private insurance (Legislative decree no. 209 of 7 September 2005), Law 194/1942 on the actuarial profession. In PT: Air and maritime transport insurance, covering goods, aircraft, hull and liability can be underwritten only by enterprises legal persons of the European Union. Only natural persons of, or enterprises established in, the European Union may act as intermediaries for such insurance business in Portugal. Existing measure: PT: Article 3 of Law 147/2015, Article 8 of Law 7/2019. With respect to Investment liberalisation \u2013 Market access, National treatment In SK: Foreign nationals may establish an insurance company in the form of a joint stock company or may conduct insurance business through their branches having a registered office in the Slovak Republic. The authorisation in both cases is subject to the evaluation of the supervisory authority. Existing measures: SK: Act 39/2015 on Insurance. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access In FI: At least one half of the members of the board of directors and the supervisory board, and the managing director of an insurance company providing statutory pension insurance shall have their place of residence in the EEA, unless the competent authorities have granted an exemption. Foreign insurers cannot obtain a licence in Finland as a branch to carry out statutory pension insurance. At least one auditor shall have his permanent residence in the EEA. For other insurance companies, residency in the EEA is required for at least one member of the board of directors, the supervisory board and the managing director. At least one auditor shall have his permanent residence in the EEA. The general agent of an insurance company of the United Kingdom must have his place of residence in Finland, unless the company has its head office in the European Union. Existing measures: FI: Laki ulkomaisista vakuutusyhti\u00f6ist\u00e4 (Act on Foreign Insurance Companies) (398/1995); Vakuutusyhti\u00f6laki (Insurance Companies Act) (521/2008); Laki vakuutusedustuksesta (Act on Insurance Mediation) (570/2005); Laki vakuutusten tarjoamisesta (Act on Insurance Distribution) (234/2018) and Laki ty\u00f6el\u00e4kevakuutusyhti\u00f6ist\u00e4 (Act on Companies providing statutory pension insurance) (354/1997). (c) Banking and other Financial Services With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Local presence: The EU: Only legal persons having their registered office in the Union can act as depositories of the assets of investment funds. The establishment of a specialised management company, having its head office and registered office in the same Member State, is required to perform the activities of management of common funds, including unit trusts, and where allowed under national law, investment companies. Existing measures: EU: Directive 2009/65/EC of the European Parliament and of the Council (2); and Directive 2011/61/EU of the European Parliament and of the Council (3). In EE: For acceptance of deposits, requirement of authorisation by the Estonian Financial Supervision Authority and registration under Estonian law as a joint-stock company, a subsidiary or a branch. Existing measures: EE: Krediidiasutuste seadus (Credit Institutions Act) \u00a7 206 and \u00a721. In SK: Investment services can only be provided by management companies which have the legal form of a joint-stock company with equity capital according to the law. Existing measures: SK: Act 566/2001 on Securities and Investment Services; and Act 483/2001 on Banks. With respect to Investment liberalisation \u2013National treatment, Senior management and board of directors In FI: At least one of the founders, the members of the board of directors, the supervisory board, the managing director of banking services providers and the person entitled to sign the name of the credit institution shall have their permanent residence in the EEA. At least one auditor shall have his permanent residence in the EEA. Existing measures: FI: Laki liikepankeista ja muista osakeyhti\u00f6muotoisista luottolaitoksista (Act on Commercial Banks and Other Credit Institutions in the Form of a Limited Company) (1501/2001); S\u00e4\u00e4st\u00f6pankkilaki (1502/2001) (Savings Bank Act); Laki osuuspankeista ja muista osuuskuntamuotoisista luottolaitoksista (1504/2001) (Act on Cooperative Banks and Other Credit Institutions in the Form of a Cooperative Bank); Laki hypoteekkiyhdistyksist\u00e4 (936/1978) (Act on Mortgage Societies); Maksulaitoslaki (297/2010) (Act on Payment Institutions); Laki ulkomaisen maksulaitoksen toiminnasta Suomessa (298/2010) (Act on the Operation of Foreign Payment Institution in Finland); and Laki luottolaitostoiminnasta (Act on Credit Institutions) (121/2007). With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services - Local presence: In IT: Services of \"consulenti finanziari\" (financial consultant). In providing the activity of door-to-door selling, intermediaries must utilise authorised financial salesmen resident within the territory of a Member State. Existing measures: IT: Articles 91-111 of Consob Regulation on Intermediaries (no. 16190 of 29 October 2007). With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Local presence: In LT: Only banks having their registered office or branch in Lithuania and authorised to provide investment services in the EEA may act as the depositories of the assets of pension funds. At least one head of a bank's administration must speak the Lithuanian language. Existing measures: LT: Law on Banks of the Republic of Lithuania of 30 March 2004 No IX-2085, as amended by the Law No XIII-729 of 16 November 2017; Law on Collective Investment Undertakings of the Republic of Lithuania of 4 July 2003 No IX-1709, as amended by the Law No XIII-1872 of 20 December 2018; Law on Supplementary Voluntary Pension Accumulation of the Republic of Lithuania of 3 June 1999 No VIII-1212 (as revised in Law No XII-70 of 20 December 2012); Law on Payments of the Republic of Lithuania of 5 June 2003 No. IX-1596, last amendment 17 of October 2019 Nr. XIII-2488 Law on Payment Institutions of the Republic of Lithuania of 10 December 2009 No. XI-549 (new version of the Law: No XIII-1093 of 17 April 2018) With respect to Cross-border trade in services \u2013 Market access: In FI: For payment services, residency or domicile in Finland may be required. Reservation No. 17 - Health and social services Sector: Health and social services Industry classification: CPC 93, 931, other than 9312, part of 93191, 9311, 93192, 93193, 93199 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Health services \u2013 hospital, ambulance, residential health services (CPC 93, 931, other than 9312, part of 93191, 9311, 93192, 93193, 93199) With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of directors: The EU: For the supply of all health services which receive public funding or State support in any form. The EU: For all privately funded health services, other than privately funded hospital, ambulance, and residential health facilities services other than hospital services. The participation of private operators in the privately funded health network may be subject to concession on a non-discriminatory basis. An economic needs test may apply. Main criteria: number of and impact on existing establishments, transport infrastructure, population density, geographic spread, and creation of new employment. This reservation does not relate to the supply of all health-related professional services, including the services supplied by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, which are covered by other reservations (CPC 931 other than 9312, part of 93191). In AT, PL and SI: The supply of privately funded ambulance services (CPC 93192). In BE: the establishment of privately funded ambulance and residential health facilities services other than hospital services (CPC 93192, 93193). In BG, CY, CZ, FI, MT and SK: The supply of privately-funded hospital, ambulance, and residential health services other than hospital services (CPC 9311, 93192, 93193). In FI: Supply of other human health services (CPC 93199). Existing measures: CZ: Act No. 372/2011 Sb. on Health Care Services and Conditions of Their Provision. FI: Laki yksityisest\u00e4 terveydenhuollosta (Act on Private Health Care) (152/1990). With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment, Senior management and boards of directors, Performance requirements: In DE: The supply of the Social Security System of Germany, where services may be provided by different companies or entities involving competitive elements which are thus not \"Services carried out exclusively in the exercise of governmental authority\". To accord better treatment in the context of a bilateral trade agreement with regard to the supply of health and social services (CPC 93). With respect to Investment liberalisation \u2013 Market access, National treatment: In DE: The ownership of hospitals run by the German Forces. To nationalise other key privately funded hospitals (CPC 93110). In FR: To the supply of privately funded laboratory analysis and testing services. With respect to Cross-border trade in services \u2013 Market access, National treatment: In FR: The supply of privately funded laboratory analysis and testing services (part of CPC 9311). Existing measures: FR: Code de la Sant\u00e9 Publique (b) Health and social services, including pension insurance With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU, with the exception of HU: The cross-border supply of health services, social services and activities or services forming part of a public retirement plan or statutory system of social security. This reservation does not relate to the supply of all health-related professional services, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, which are covered by other reservations (CPC 931 other than 9312, part of 93191). In HU: The cross-border supply of all hospital, ambulance, and residential health services other than hospital services, which receive public funding (CPC 9311, 93192, 93193). (c) Social services, including pension insurance With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements: The EU: The supply of all social services which receive public funding or State support in any form and activities or services forming part of a public retirement plan or statutory system of social security. The participation of private operators in the privately funded social network may be subject to concession on a non-discriminatory basis. An economic needs test may apply. Main criteria: number of and impact on existing establishments, transport infrastructure, population density, geographic spread, and creation of new employment. In BE, CY, DE, DK, EL, ES, FR, IE, IT and PT: The supply of privately funded social services other than services relating to convalescent and rest houses and old people's homes. In CZ, FI, HU, MT, PL, RO, SK, and SI: The supply of privately funded social services. In DE: The Social Security System of Germany, where services are provided by different companies or entities involving competitive elements and might therefore not fall under the definition of the \"Services carried out exclusively in the exercise of governmental authority\". Existing measures: FI: Laki yksityisist\u00e4 sosiaalipalveluista (Private Social Services Act) (922/2011). IE: Health Act 2004 (S. 39); and Health Act 1970 (as amended \u2013S.61A). IT: Law 833/1978 Institution of the public health system; Legislative Decree 502/1992 Organisation and discipline of the health field; and Law 328/2000 Reform of social services. Reservation No. 18 - Tourism and travel related services Sector: Tourist guides services, health and social services Industry classification: CPC 7472 Type of reservation: National treatment Most-favoured-nation treatment Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: With respect to Investment liberalisation \u2013National treatment and Cross-border trade in services \u2013 National treatment: In FR: To require nationality of a Member State for the supply of tourist guide services. With respect to Investment liberalisation \u2013 Most-favoured-nation treatment and Cross-border trade in services \u2013 Most-favoured-nation treatment: In LT: In so far as the United Kingdom allows nationals of Lithuania to provide tourist guide services, Lithuania will allow nationals of the United Kingdom to provide tourist guide services under the same conditions. Reservation No. 19 - Recreational, cultural and sporting services Sector: Recreational, cultural and sporting services Industry classification: CPC 962, 963, 9619, 964 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Libraries, archives, museums and other cultural services (CPC963) With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU, with the exception of AT and, for investment liberalisation, in LT: The supply of library, archive, museum and other cultural services. In AT and LT: A licence or concession may be required for establishment. (b) Entertainment services, theatre, live bands and circus services (CPC 9619, 964 other than 96492) With respect to Cross-border trade in services \u2013 Market access, National treatment: The EU, with the exception of AT and SE: The cross-border supply of entertainment services, including theatre, live bands, circus and discotheque services. With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In CY, CZ, FI, MT, PL, RO, SI and SK: With respect to the supply of entertainment services, including theatre, live bands, circus and discotheque services. In BG: The supply of the following entertainment services: circus, amusement park and similar attraction services, ballroom, discotheque and dance instructor services, and other entertainment services. In EE: The supply of other entertainment services except for cinema theatre services. In LT and LV: The supply of all entertainment services other than cinema theatre operation services. In CY, CZ, LV, PL, RO and SK: The cross-border supply of sporting and other recreational services. (c) News and press agencies (CPC 962) With respect to Investment liberalisation \u2013 Market access, National treatment: In FR: Foreign participation in existing companies publishing publications in the French language may not exceed 20 per cent of the capital or of voting rights in the company. The establishment of press agencies of the United Kingdom is subject to conditions set out in domestic regulation. The establishment of press agencies by foreign investors is subject to reciprocity. Existing measures: FR: Ordonnance n\u00b0 45-2646 du 2 novembre 1945 portant r\u00e8glementation provisoire des agences de presse; and Loi n\u00b0 86-897 du 1 ao\u00fbt 1986 portant r\u00e9forme du r\u00e9gime juridique de la presse. With respect to Cross-border trade in services \u2013 Market access: In HU: For supply of news and press agencies services. (d) Gambling and betting services (CPC 96492) With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: The supply of gambling activities, which involve wagering a stake with pecuniary value in games of chance, including in particular lotteries, scratch cards, gambling services offered in casinos, gambling arcades or licensed premises, betting services, bingo services and gambling services operated by and for the benefit of charities or non-profit-making organisations. Reservation No. 20 - Transport services and auxiliary transport services Sector: Transport services Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Maritime transport \u2013 any other commercial activity undertaken from a ship With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment: The EU: The nationality of the crew on a seagoing or non-seagoing vessel. With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment, Senior management and boards of directors: The EU, except LV and MT: Only EU natural or legal persons may register a vessel and operate a fleet under the national flag of the state of establishment (applies to all commercial marine activity undertaken from a seagoing ship, including fishing, aquaculture, and services incidental to fishing; international passenger and freight transportation (CPC 721); and services auxiliary to maritime transport). With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access: In MT: Exclusive rights exist for the maritime link to mainland Europe through Italy with Malta (CPC 7213, 7214, part of 742, 745, part of 749). With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: In SK: Foreign investors must have their principal office in the Slovak Republic in order to apply for a licence enabling them to provide a service (CPC 722). (b) Auxiliary services to maritime transport With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: The supply of pilotage and berthing services. For greater certainty, regardless of the criteria which may apply to the registration of ships in a Member State of the European Union, the European Union reserves the right to require that only ships registered on the national registers of Member States of the European Union may provide pilotage and berthing services (CPC 7452). The EU, with the exception of LT and LV: Only vessels carrying the flag of a Member State of the European Union may provide pushing and towing services (CPC 7214). With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013National treatment, Local presence: In LT: Only juridical persons of Lithuania or juridical persons of a Member State of the European Union with branches in Lithuania that have a Certificate issued by the Lithuanian Maritime Safety Administration may provide pilotage and berthing, pushing and towing services (CPC 7214, 7452). With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In BE: Cargo handling services can only be operated by accredited workers, eligible to work in port areas designated by royal decree (CPC 741). Existing measures: BE: Loi du 8 juin 1972 organisant le travail portuaire; Arr\u00eat\u00e9 royal du 12 janvier 1973 instituant une Commission paritaire des ports et fixant sa d\u00e9nomination et sa comp\u00e9tence; Arr\u00eat\u00e9 royal du 4 septembre 1985 portant agr\u00e9ment d'une organisation d'employeur (Anvers); Arr\u00eat\u00e9 royal du 29 janvier 1986 portant agr\u00e9ment d'une organisation d'employeur (Gand); Arr\u00eat\u00e9 royal du 10 juillet 1986 portant agr\u00e9ment d'une organisation d'employeur (Zeebrugge); Arr\u00eat\u00e9 royal du 1er mars 1989 portant agr\u00e9ment d'une organisation d'employeur (Ostende); and Arr\u00eat\u00e9 royal du 5 juillet 2004 relatif \u00e0 la reconnaissance des ouvriers portuaires dans les zones portuaires tombant dans le champ d'application de la loi du 8 juin 1972 organisant le travail portuaire, tel que modifi\u00e9. (c) Auxiliary services to inland waterways transport With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment, Local presence, Most favoured-nation treatment: The EU: Services auxiliary to inland waterways transportation. (d) Rail transport and auxiliary services to rail transport With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In EU: Railway passenger transportation (CPC 7111). With respect to Investment liberalisation \u2013 Market access, and Cross-border trade in services \u2013 Market access, Local Presence: In EU: Railway freight transportation (CPC 7112). In LT: Maintenance and repair services of rail transport equipment are subject to a state monopoly (CPC 86764, 86769, part of 8868). In SE (with respect only to Market access): Maintenance and repair services of rail transport equipment are subject to an economic needs test when an investor intends to establish its own terminal infrastructure facilities. Main criteria: space and capacity constraints (CPC 86764, 86769, part of 8868). Existing measures: EU: Directive 2012/34/EU of the European Parliament and of the Council (4). SE: Planning and Building Act (2010:900). (e) Road transport (passenger transportation, freight transportation, international truck transport services) and services auxiliary to road transport With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: For road transport services covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors: The EU: For road transport services covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement: To limit the supply of cabotage within a Member State by foreign investors established in another Member State (CPC 712). With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: For road transport services not covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement: (i) to require establishment and to limit the cross-border supply of road transport services (CPC 712). (ii) to limit the supply of cabotage within a Member State by foreign investors established in another Member State (CPC 712). (iii) an economic needs test may apply to taxi services in the Union setting a limit on the number of service suppliers. Main criteria: local demand as provided in applicable laws (CPC 71221). With respect to Investment liberalisation \u2013 Market access: In BE: A maximum number of licences can be fixed by law (CPC 71221). In IT: An economic needs test is applied to limousine services. Main criteria: number of and impact on existing establishments, population density, geographical spread, impact on traffic conditions and creation of new employment. An economic needs test is applied to intercity bussing services. Main criteria: number of and impact on existing establishments, population density, geographical spread, impact on traffic conditions and creation of new employment. An economic needs test is applied to the supply of freight transportation services. Main criteria: local demand (CPC 712). In BG, DE: For passenger and freight transportation, exclusive rights or authorisations may only be granted to natural persons of the Union and to legal persons of the Union having their headquarters in the Union. (CPC 712). In MT: For public bus service: The entire network is subject to a concession which includes a Public Service Obligation agreement to cater for certain social sectors (such as students and the elderly) (CPC 712). With respect to Investment liberalisation \u2013 Market access, National treatment, In FI: Authorisation is required to provide road transport services, which is not extended to foreign registered vehicles (CPC 712). With respect to Investment liberalisation \u2013 Market access, National treatment: In FR: The supply of intercity bussing services (CPC 712). With respect to Investment liberalisation \u2013 Market access: In ES: For passenger transportation, an economic needs test applies to services provided under CPC 7122. Main criteria: local demand. An economic needs test applies for intercity bussing services. Main criteria: number of and impact on existing establishments, population density, geographical spread, impact on traffic conditions and creation of new employment. In SE: Maintenance and repair services of road transport equipment are subject to an economic needs test when a supplier intends to establish its own terminal infrastructure facilities. Main criteria: space and capacity constraints (CPC 6112, 6122, 86764, 86769, part of 8867). In SK: For freight transportation, an economic needs test is applied. Main criteria: local demand (CPC 712). With respect to Cross-border trade in services \u2013 Market access: In BG: To require establishment for supporting services to road transport (CPC 744). Existing measures: EU: Regulation (EC) No 1071/2009 of the European Parliament and of the Council (5); Regulation (EC) No 1072/2009 of the European Parliament and of the Council (6); and Regulation (EC) No 1073/2009 of the European Parliament and of the Council (7). FI: Laki kaupallisista tavarankuljetuksista tiell\u00e4 (Act on Commercial Road Transport) 693/2006; Laki liikenteen palveluista (Act on Transport Services) 320/2017; Ajoneuvolaki (Vehicles Act) 1090/2002. IT: Legislative decree 285/1992 (Road Code and subsequent amendments) article 85; Legislative Decree 395/2000 article 8 (road transport of passengers); Law 21/1992 (Framework law on non-scheduled public road transport of passengers); Law 218/2003 article 1 (transport of passenger through rented buses with driver); and Law 151/1981 (framework law on public local transport). SE: Planning and Building Act (2010:900). (f) Space transport and rental of space craft With respect to Investment liberalisation \u2013 Market access, National treatment, Performance requirements, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: The supply of space transport services and the supply of rental of space craft services (CPC 733, part of 734). (g) Most-favoured-nation exemptions With respect to Investment liberalisation \u2013 Most-favoured-nation treatment, and Cross-border trade in services \u2013 Most-favoured-nation treatment: \u2014 Transport (cabotage) other than maritime transport In FI: According differential treatment to a country pursuant to existing or future bilateral agreements exempting vessels registered under the foreign flag of a specified other country or foreign registered vehicles from the general prohibition from providing cabotage transport (including combined transport, road and rail) in Finland on the basis of reciprocity (part of CPC 711, part of 712, part of 722). \u2014 Supporting services for maritime transport In BG: In so far as the United Kingdom allows service suppliers from Bulgaria to supply cargo-handling services and storage and warehouse services in sea and river harbours, including services relating to containers and goods in containers, Bulgaria will allow service suppliers from the United Kingdom to supply cargo-handling services and storage and warehouse services in sea and river harbours, including services relating to containers and goods in containers under the same conditions (part of CPC 741, part of 742). \u2014 Rental or leasing of vessels In DE: Chartering-in of foreign ships by consumers resident in Germany may be subject to a condition of reciprocity (CPC 7213, 7223, 83103). \u2014 Road and rail transport The EU: To accord differential treatment to a country pursuant to existing or future bilateral agreements relating to international road haulage (including combined transport \u2013 road or rail) and passenger transport, concluded between the Union or the Member States and a third country (CPC 7111, 7112, 7121, 7122, 7123). That treatment may: (a) reserve or limit the supply of the relevant transport services between the contracting Parties or across the territory of the contracting Parties to vehicles registered in each contracting Party (8); or (b) provide for tax exemptions for such vehicles. \u2014 Road transport In BG: Measures taken under existing or future agreements, which reserve or restrict the supply of these kinds of transportation services and specify the terms and conditions of this supply, including transit permits or preferential road taxes, in the territory of Bulgaria or across the borders of Bulgaria (CPC 7121, 7122, 7123). In CZ: Measures that are taken under existing or future agreements, and which reserve or limit the supply of transport services and specify operating conditions, including transit permits or preferential road taxes of a transport services into, in, across and out of the Czech Republic to the contracting parties concerned (CPC 7121, 7122, 7123). In ES: Authorisation for the establishment of a commercial presence in Spain may be refused to service suppliers whose country of origin does not accord effective market access to service suppliers of Spain (CPC 7123). Existing measures: Ley 16/1987, de 30 de julio, de Ordenaci\u00f3n de los Transportes Terrestres. In HR: Measures applied under existing or future agreements on international road transport and which reserve or limit the supply of transport services and specify operating conditions, including transit permits or preferential road taxes of transport services into, in, across and out of Croatia to the parties concerned (CPC 7121, 7122, 7123). In LT: Measures that are taken under bilateral agreements and which set the provisions for transport services and specify operating conditions, including bilateral transit and other transport permits for transport services into, through and out of the territory of Lithuania to the contracting parties concerned, and road taxes and levies (CPC 7121, 7122, 7123). In SK: Measures that are taken under existing or future agreements, and which reserve or limit the supply of transport services and specify operating conditions, including transit permits or preferential road taxes of a transport services into, in, across and out of the Slovak Republic to the contracting parties concerned (CPC 7121, 7122, 7123). \u2014 Rail transport In BG, CZ and SK: For existing or future agreements, and which regulate traffic rights and operating conditions, and the supply of transport services in the territory of Bulgaria, the Czech Republic and Slovakia and between the countries concerned. (CPC 7111, 7112). \u2014 Air transport - Services auxiliary to air transport The EU: According differential treatment to a third country pursuant to existing or future bilateral agreements relating to ground-handling services. \u2014 Road and rail transport In EE: when according differential treatment to a country pursuant to existing or future bilateral agreements on international road transport (including combined transport-road or rail), reserving or limiting the supply of a transport services into, in, across and out of Estonia to the contracting Parties to vehicles registered in each contracting Party, and providing for tax exemption for such vehicles (part of CPC 711, part of 712, part of 721). \u2014 All passenger and freight transport services other than maritime and air transport In PL: In so far as the United Kingdom allows the supply of transport services into and across the territory of the United Kingdom by passenger and freight transport suppliers of Poland, Poland will allow the supply of transport services by passenger and freight transport suppliers of the United Kingdom into and across the territory of Poland under the same conditions. Reservation No. 21 - Agriculture, fishing and water Sector: Agriculture, hunting, forestry; fishing, aquaculture, services incidental to fishing; collection, purification and distribution of water Industry classification: ISIC Rev. 3.1 011, ISIC Rev. 3.1 012, ISIC Rev. 3.1 013, ISIC Rev. 3.1 014, ISIC Rev. 3.1 015, CPC 8811, 8812, 8813 other than advisory and consultancy services; ISIC Rev. 3.1 0501, 0502, CPC 882 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Agriculture, hunting and forestry With respect to Investment liberalisation \u2013 Market access, National treatment: In HR: Agricultural and hunting activities. In HU: Agricultural activities (ISIC Rev. 3.1 011, 3.1 012, 3.1 013, 3.1 014, 3.1 015, CPC 8811, 8812, 8813 other than advisory and consultancy services). Existing measures: HR: Agricultural Land Act (OG 20/18, 115/18, 98/19) (b) Fishing, aquaculture and services incidental to fishing (ISIC Rev. 3.1 0501, 0502, CPC 882) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements, Most-favoured-nation treatment and Cross-border trade in services \u2013 Market access, National treatment, Most-favoured-nation treatment, Local presence: The EU: 1. In particular within the framework of the Common Fisheries Policy, and of fishing agreements with a third country, access to and use of the biological resources and fishing grounds situated in maritime waters coming under the sovereignty or the jurisdiction of Member States, or entitlements for fishing under a Member State fishing licence, including: (a) regulating the landing of catches by vessels flying the flag of the United Kingdom or a third country with respect to the quotas allocated to them or, only with respect to vessels flying the flag of a Member State, requiring that a proportion of the total catch is landed in Union ports; (b) determining a minimum size for a company in order to preserve both artisanal and coastal fishing vessels; (c) according differential treatment pursuant to existing or future bilateral agreements relating to fisheries; and (d) requiring the crew of a vessel flying the flag of a Member State to be nationals of Member States. 2. A fishing vessel\u2019s entitlement to fly the flag of a Member State only if: (a) it is wholly owned by: (i) companies incorporated in the Union; or (ii) Member State nationals; (b) its day-to-day operations are directed and controlled from within the Union; and (c) any charterer, manager or operator of the vessel is a company incorporated in the Union or a national of a Member State. 3. A commercial fishing licence granting the right to fish in the territorial waters of a Member State may only be granted to vessels flying the flag of a Member State. 4. The establishment of marine or inland aquaculture facilities. 5. Point (a), (b), (c) (other than with respect to most-favoured nation treatment) and (d) of paragraph 1; point (a)(i), point (b) and (c) of paragraph 2 and paragraph 3 only apply to measures which are applicable to vessels or to enterprises irrespective of the nationality of their beneficial owners. With respect to Investment liberalisation \u2013 Market access: In FR: Nationals of non-European Union countries cannot participate in French maritime State property for fish, shellfish or algae farming. With respect to Investment liberalisation \u2013 Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services \u2013 Market access, National treatment: In BG: The taking of marine and river-living resources, performed by vessels in the internal marine waters, and the territorial sea of Bulgaria, shall be performed by vessels flying the flag of Bulgaria. A foreign ship may not engage in commercial fishing in the exclusive economic zone save on the basis of an agreement between Bulgaria and the flag state. While passing through the exclusive economic zone, foreign fishing ships may not maintain their fishing gear in operational mode. (c) Collection, purification and distribution of water With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: For activities, including services relating to the collection, purification and distribution of water to household, industrial, commercial or other users, including the supply of drinking water, and water management. Reservation No. 22 - Energy related activities Sector: Production of energy and related services Industry classification: ISIC Rev. 3.1 10, 1110, 12, 120, 1200, 13, 14, 232, 233, 2330, 40, 401, 4010, 402, 4020, part of 4030, CPC 613, 62271, 63297, 7131, 71310, 742, 7422, part of 88, 887. Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Energy services \u2013 general (ISIC Rev. 3.1 10, 1110, 13, 14, 232, 40, 401, 402, part of 403, 41; CPC 613, 62271, 63297, 7131, 742, 7422, 887 (other than advisory and consulting services)) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: Where a Member State permits foreign ownership of a gas or electricity transmission system, or an oil and gas pipeline transport system, with respect to enterprises of the United Kingdom controlled by natural or legal persons of a third country which accounts for more than 5 per cent of the Union's oil, natural gas or electricity imports, in order to guarantee the security of the energy supply of the Union as a whole, or of an individual Member State. This reservation does not apply to advisory and consultancy services provided as services incidental to energy distribution. This reservation does not apply to HR, HU and LT (for LT, only CPC 7131) with regard to the pipeline transport of fuels, nor to LV with regard to services incidental to energy distribution, nor to SI with regard to services incidental to the distribution of gas (ISIC Rev. 3.1 401, 402, CPC 7131, 887 other than advisory and consultancy services). In CY: For the manufacture of refined petroleum products in so far as the investor is controlled by a natural or juridical person of a third country which accounts for more than 5 per cent of the Union's oil or natural gas imports, as well as to the manufacture of gas, distribution of gaseous fuels through mains on own account, the production, transmission and distribution of electricity, the pipeline transportation of fuels, services incidental to electricity and natural gas distribution other than advisory and consulting services, wholesale services of electricity, retailing services of motor fuel, electricity and non-bottled gas. Nationality and residency conditions applies for electricity related services. (ISIC Rev. 3.1 232, 4010, 4020, CPC 613, 62271, 63297, 7131, and 887 other than advisory and consulting services). In FI: The transmission and distribution networks and systems of energy and of steam and hot water. In FI: The quantitative restrictions in the form of monopolies or exclusive rights for the importation of natural gas, and for the production and distribution of steam and hot water. Currently, natural monopolies and exclusive rights exist (ISIC Rev. 3.1 40, CPC 7131, 887 other than advisory and consultancy services). In FR: The electricity and gas transmission systems and oil and gas pipeline transport (CPC 7131). With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In BE: The energy distribution services, and services incidental to energy distribution (CPC 887 other than consultancy services). With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013National treatment, Local presence: In BE: For energy transmission services, regarding the types of legal entities and to the treatment of public or private operators to whom BE has conferred exclusive rights. Establishment is required within the Union (ISIC Rev. 3.1 4010, CPC 71310). In BG: For services incidental to energy distribution (part of CPC 88). In PT: For the production, transmission and distribution of electricity, the manufacturing of gas, the pipeline transportation of fuels, wholesale services of electricity, retailing services of electricity and non-bottled gas, and services incidental to electricity and natural gas distribution. Concessions for electricity and gas sectors are assigned only to limited companies with their headquarters and effective management in PT (ISIC Rev. 3.1 232, 4010, 4020, CPC 7131, 7422, 887 other than advisory and consulting services). In SK: An authorisation is required for the production, transmission and distribution of electricity, manufacture of gas and distribution of gaseous fuels, production and distribution of steam and hot water, pipeline transportation of fuels, wholesale and retail of electricity, steam and hot water, and services incidental to energy distribution, including services in the area of energy efficiency, energy savings and energy audit. An economic needs test is applied and the application may be denied only if the market is saturated. For all those activities, an authorisation may only be granted to a natural person with permanent residency in the EEA or a legal person of the EEA. With respect to Investment liberalisation \u2013 Market access, National treatment: In BE: With the exception of the mining of metal ores and other mining and quarrying, enterprises controlled by natural or legal persons of a third country which accounts for more than 5 per cent of the European Union's oil or natural gas or electricity imports may be prohibited from obtaining control of the activity. Incorporation is required (no branching) (ISIC Rev. 3.1 10, 1110, 13, 14, 232, part of 4010, part of 4020, part of 4030). Existing measures: EU: Directive (EU) 2019/944 of the European Parliament and of the Council (9); and Directive 2009/73/EC of the European Parliament and of the Council (10). BG: Energy Act. CY: The Regulation of the Electricity Market Laws of 2003 Law 122(I)/2003 as amended; The Regulation of the Gas Market Laws of 2004, Law 183(I)/2004 as amended; The Petroleum (Pipelines) Law, Chapter 273; The Petroleum Law Chapter 272 as amended; and The Petroleum and Fuel Specifications Laws of 2003, Law 148(I)/2003 as amended. FI: Maakaasumarkkinalaki (Natural Gas Market Act) (508/2000); and S\u00e4hk\u00f6markkinalaki (Electricity Market Act) (386/1995). Maakaasumarkkinalaki (Natural Gas Market Act) (587/2017) FR: Code de l'\u00e9nergie. PT: Decree-Law 230/2012 and Decree-Law 231/2012, 26 October - Natural Gas; Decree-Law 215-A/2012, and Decree-Law 215-B/2012, 8 October \u2013 Electricity; and Decree-Law 31/2006, 15 February \u2013 Crude oil/Petroleum products. SK: Act 51/1988 on Mining, Explosives and State Mining Administration; Act 569/2007 on Geological Works; Act 251/2012 on Energy; and Act 657/2004 on Thermal Energy. (b) Electricity (ISIC Rev. 3.1 40, 401; CPC 62271, 887 (other than advisory and consulting services)) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment: In FI: The importation of electricity. With respect to cross-border trade, the wholesale and retail of electricity. In FR: Only companies where 100 per cent of the capital is held by the French State, by another public sector organisation or by Electricit\u00e9 de France (EDF), may own and operate electricity transmission or distribution systems. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In BG: For the production of electricity and the production of heat. In PT: The activities of electricity transmission and distribution are carried out through exclusive concessions of public service. With respect to Investment liberalisation \u2013 Market access, National treatment: In BE: An individual authorisation for the production of electricity of a capacity of 25 MW or above requires establishment in the Union, or in another State which has a regime similar to that enforced by Directive 96/92/EC of the European Parliament and of the Council (11) in place, and where the company has an effective and continuous link with the economy. The production of electricity within the offshore territory of BE is subject to concession and a joint venture obligation with a legal person of the Union, or with a legal person of a country having a regime similar to that of Directive 2003/54/EC of the European Parliament and of the Council (12), particularly with regard to conditions relating to the authorisation and selection. Additionally, the legal person should have its central administration or its head office in a Member State of the European Union or a country meeting the above criteria, where it has an effective and continuous link with the economy. The construction of electrical power lines which link offshore production to the transmission network of Elia requires authorisation and the company must meet the previously specified conditions, except for the joint venture requirement. With respect to Cross-border trade in services \u2013 National treatment: In BE: An authorisation is necessary for the supply of electricity by an intermediary having customers established in BE who are connected to the national grid system or to a direct line whose nominal voltage is higher than 70,000 volts. That authorisation may only be granted to a natural or legal person of the EEA. With respect to Investment liberalisation \u2013 Market access: In FR: For the production of electricity. Existing measures: BE: Arr\u00eat\u00e9 Royal du 11 octobre 2000 fixant les crit\u00e8res et la proc\u00e9dure d'octroi des autorisations individuelles pr\u00e9alables \u00e0 la construction de lignes directes; Arr\u00eat\u00e9 Royal du 20 d\u00e9cembre 2000 relatif aux conditions et \u00e0 la proc\u00e9dure d'octroi des concessions domaniales pour la construction et l'exploitation d'installations de production d'\u00e9lectricit\u00e9 \u00e0 partir de l'eau, des courants ou des vents, dans les espaces marins sur lesquels la Belgique peut exercer sa juridiction conform\u00e9ment au droit international de la mer; and Arr\u00eat\u00e9 Royal du 12 mars 2002 relatif aux modalit\u00e9s de pose de c\u00e2bles d'\u00e9nergie \u00e9lectrique qui p\u00e9n\u00e8trent dans la mer territoriale ou dans le territoire national ou qui sont install\u00e9s ou utilis\u00e9s dans le cadre de l'exploration du plateau continental, de l'exploitation des ressources min\u00e9rales et autres ressources non vivantes ou de l'exploitation d'\u00eeles artificielles, d'installations ou d'ouvrages relevant de la juridiction belge. Arr\u00eat\u00e9 royal relatif aux autorisations de fourniture d'\u00e9lectricit\u00e9 par des interm\u00e9diaires et aux r\u00e8gles de conduite applicables \u00e0 ceux-ci. Arr\u00eat\u00e9 royal du 12 juin 2001 relatif aux conditions g\u00e9n\u00e9rales de fourniture de gaz naturel et aux conditions d'octroi des autorisations de fourniture de gaz naturel. FI: Maakaasumarkkinalaki (Natural Gas Market Act) (508/2000); and S\u00e4hk\u00f6markkinalak (Electricity Market Act) 588/2013; Maakaasumarkkinalaki (Natural Gas Market Act) (587/2017) FR: Code de l'\u00e9nergie. PT: Decree-Law 215-A/2012; and Decree-Law 215-B/2012, 8 October \u2013 Electricity. (c) Fuels, gas, crude oil or petroleum products (ISIC Rev. 3.1 232, 40, 402; CPC 613, 62271, 63297, 7131, 71310, 742, 7422, part of 88, 887 (other than advisory and consulting services)) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment: In FI: To prevent control or ownership of a liquefied natural gas (LNG) terminal (including those parts of the LNG terminal used for storage or re-gasification of LNG) by foreign natural or legal persons for energy security reasons. In FR: Only companies where 100 per cent of the capital is held by the French State, by another public sector organisation or by ENGIE, may own and operate gas transmission or distribution systems for reasons of national energy security. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In BE: For bulk storage services of gas, regarding the types of legal entities and the treatment of public or private operators to whom Belgium has conferred exclusive rights. Establishment is required within the Union for bulk storage services of gas (part of CPC 742). In BG: For pipeline transportation, storage and warehousing of petroleum and natural gas, including transit transmission (CPC 71310, part of CPC 742). In PT: For the cross-border supply of storage and warehousing services of fuels transported through pipelines (natural gas). Also, concessions relating to the transmission, distribution and underground storage of natural gas and the reception, storage and regasification terminal of LNG are awarded through contracts concession, following public calls for tenders (CPC 7131, CPC 7422). With respect to Cross-border trade in services \u2013 Market access, National treatment: In BE: The pipeline transport of natural gas and other fuels is subject to an authorisation requirement. An authorisation may only be granted to a natural or juridical person established in a Member State (in accordance with Article 3 of the AR of 14 May 2002). Where the authorisation is requested by a company: (a) the company must be established in accordance with Belgian law, or the law of another Member State, or the law of a third country, which has undertaken commitments to maintain a regulatory framework similar to the common requirements specified in Directive 98/30/EC of the European Parliament and the Council (13); and (b) the company must hold its administrative seat, its principal establishment or its head office within a Member State, or a third country, which has undertaken commitments to maintain a regulatory framework similar to the common requirements specified in Directive 98/30/EC, provided that the activity of this establishment or head office represents an effective and continuous link with the economy of the country concerned (CPC 7131). In BE: In general the supply of natural gas to customers (customers being both distribution companies and consumers whose overall combined consumption of gas arising from all points of supply attains a minimum level of one million cubic metres per year) established in Belgium is subject to an individual authorisation provided by the minister, except where the supplier is a distribution company using its own distribution network. Such an authorisation may only be granted to natural or legal persons of the European Union. In CY: For the cross-border supply of storage and warehousing services of fuels transported through pipelines, and the retail sales of fuel oil and bottled gas other than by mail order (CPC 613, CPC 62271, CPC 63297, CPC 7131, CPC 742). With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access: In HU: The supply of pipeline transport services requires establishment. Services may be provided through a Contract of Concession granted by the state or the local authority. The supply of this service is regulated by the Hungarian Concession Law (CPC 7131). With respect to Cross-border trade in services \u2013 Market access: In LT: For pipeline transportation of fuels and services auxiliary to pipeline transport of goods other than fuel. Existing measures: BE: Arr\u00eat\u00e9 Royal du 14 mai 2002 relatif \u00e0 l'autorisation de transport de produits gazeux et autres par canalisations; and Loi du 12 avril 1965 relative au transport de produits gazeux et autres par canalisations (article 8.2). BG: Energy Act. CY: The Regulation of the Electricity Market Law of 2003, Law 122(I)/2003 as amended; The Regulating of the Gas Market Laws of 2004, Law 183(I)/2004 as amended; The Petroleum (Pipelines) Law, Chapter 273; The Petroleum Law Chapter 272 as amended; and The Petroleum and Fuel Specifications Laws of 2003, Law 148(I)/2003 as amended. FI: Maakaasumarkkinalaki (Natural Gas Market Act) (508/2000); and Maakaasumarkkinalaki (Natural Gas Market Act) (587/2017). FR: Code de l'\u00e9nergie. HU: Act XVI of 1991 about Concessions. LT: Law on Natural Gas of the Republic of Lithuania of 10 October 2000 No VIII-1973. PT: Decree-Law 230/2012 and Decree-Law 231/2012, 26 October - Natural Gas; Decree-Law 215-A/2012, and Decree-Law 215-B/2012, 8 October \u2013 Electricity; and Decree-Law 31/2006, 15 February \u2013 Crude oil/Petroleum products. (d) Nuclear (ISIC Rev. 3.1 12, 3.1 23, 120, 1200, 233, 2330, 40, part of 4010, CPC 887)) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment: In DE: For the production, processing or transportation of nuclear material and generation or distribution of nuclear-based energy. With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, National treatment: In AT and FI: for the production, processing distribution or transportation of nuclear material and generation or distribution of nuclear-based energy. In BE: For the production, processing or transportation of nuclear material and generation or distribution of nuclear-based energy. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements: In HU and SE: For the processing of nuclear fuel and nuclear-based electricity generation. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors: In BG: For the processing of fissionable and fusionable materials or the materials from which they are derived, as well as to the trade therewith, to the maintenance and repair of equipment and systems in nuclear energy production facilities, to the transportation of those materials and the refuse and waste matter of their processing, to the use of ionising radiation, and on all other services relating to the use of nuclear energy for peaceful purposes (including engineering and consulting services and services relating to software etc.). With respect to Investment liberalisation \u2013 Market access, National treatment: In FR: These activities must respect the obligations of an Euratom Agreement. Existing measures: AT: Bundesverfassungsgesetz f\u00fcr ein atomfreies \u00d6sterreich (Constitutional Act for a Non-nuclear Austria) BGBl. I Nr. 149/1999. BG: Safe Use of Nuclear Energy Act. FI: Ydinenergialaki (Nuclear Energy Act) (990/1987). HU: Act CXVI of 1996 on Nuclear Energy; and Government Decree Nr. 72/2000 on Nuclear Energy. SE: The Swedish Environmental Code (1998:808); and Law on Nuclear Technology Activities (1984:3). Reservation No. 23 - Other services not included elsewhere Sector: Other services not included elsewhere Industry classification: CPC 9703, part of CPC 612, part of CPC 621, part of CPC 625, part of 85990 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Funeral, cremation services and undertaking services (CPC 9703) With respect to Investment liberalisation \u2013 Market access, National treatment: In FI: Cremation services and operation/maintenance of cemeteries and graveyards can only be performed by the state, municipalities, parishes, religious communities or non-profit foundations or societies. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, National treatment, Local presence: In DE: Only legal persons established under public law may operate a cemetery. The creation and operation of cemeteries and services related to funerals. In PT: Commercial presence is required to provide funeral and undertaking services. EEA nationality is required in order to become a technical manager for entities providing funeral and undertaking services. In SE: Church of Sweden or local authority monopoly on cremation and funeral services. In CY, SI: Funeral, cremation and undertaking services. Existing measures: FI: Hautaustoimilaki (Act on Burial Service) (457/2003). PT: Decree-Law 10/2015, of 16 January alterado p/ Lei 15/2018, 27 mar\u00e7o. SE: Begravningslag (1990:1144) (Act of Burials); Begravningsf\u00f6rordningen (1990:1147) (Ordinance of Burials). (b) Other business-related services With respect to Cross-border trade in services \u2013 Market access: In FI: Require establishment in Finland or elsewhere in the EEA in order to provide electronic identification services. Existing measures: FI: Laki vahvasta s\u00e4hk\u00f6isest\u00e4 tunnistamisesta ja s\u00e4hk\u00f6isist\u00e4 luottamuspalveluista 617/2009 (Act on Strong Electronic Identification and Electronic Trust Services 617/2009). (c) New services With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, National treatment, Local presence: The EU: For the provision of new services other than those classified in the United Nations Provisional Central Product Classification (CPC), 1991. Schedule of the United Kingdom Reservation No. 1 \u2013 All sectors Reservation No. 2 \u2013 Professional services (all professions except health related) Reservation No. 3 \u2013 Professional services (health related and retail of pharmaceuticals) Reservation No. 4 \u2013 Business services (collection agency services and credit reporting services) Reservation No. 5 \u2013 Business services (placement services) Reservation No. 6 \u2013 Business services (investigation services) Reservation No. 7 \u2013 Business services (other business services) Reservation No. 8 \u2013 Education services Reservation No. 9 \u2013 Financial services Reservation No. 10 \u2013 Health and social services Reservation No. 11 \u2013 Recreational, cultural and sporting services Reservation No. 12 \u2013 Transport services and auxiliary transport services Reservation No. 13 \u2013 Fishing and water Reservation No. 14 \u2013 Energy related activities Reservation No. 15 \u2013 Other services not included elsewhere Reservation No. 1 \u2013 All sectors Sector: All sectors Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Obligations for Legal Services Chapter/ Section: Investment liberalisation, Cross-border trade in services and Regulatory framework for legal services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Commercial presence With respect to Investment liberalisation \u2013 Market access: Services considered as public utilities at a national or local level may be subject to public monopolies or to exclusive rights granted to private operators. Public utilities exist in sectors such as related scientific and technical consulting services, research and development (R&D) services on social sciences and humanities, technical testing and analysis services, environmental services, health services, transport services and services auxiliary to all modes of transport. Exclusive rights on such services are often granted to private operators, for instance operators with concessions from public authorities, subject to specific service obligations. Given that public utilities often also exist at the sub-central level, detailed and exhaustive sector-specific scheduling is not practical. This reservation does not apply to telecommunications and to computer and related services. (b) Most-favoured-nation treatment With respect to Investment liberalisation \u2013 Most favoured nation treatment and Cross-Border Trade in Services \u2013 Most favoured nation treatment and Regulatory Framework for Legal Services \u2013 Obligations: According differential treatment pursuant to any international investment treaties or other trade agreement in force or signed prior to entry into force of this Agreement. According differential treatment to a country pursuant to any existing or future bilateral or multilateral agreement which: (i) creates an internal market in services and investment; (ii) grants the right of establishment; or (iii) requires the approximation of legislation in one or more economic sectors. An internal market on services and establishment means an area without internal frontiers in which the free movement of services, capital and persons is ensured. The right of establishment means an obligation to abolish in substance all barriers to establishment among the parties to the regional economic integration agreement by the entry into force of that agreement. The right of establishment shall include the right of nationals of the parties to the regional economic integration agreement to set up and operate enterprises under the same conditions provided for nationals under the law of the country where such establishment takes place. The approximation of legislation means: (i) the alignment of the legislation of one or more of the parties to the regional economic integration agreement with the legislation of the other party or parties to that agreement; or (ii) the incorporation of common legislation into the law of the parties to the regional economic integration agreement. Such alignment or incorporation shall take place, and shall be deemed to have taken place, only at such time that it has been enacted in the law of the party or parties to the regional economic integration agreement. According differential treatment relating to the right of establishment to nationals or enterprises through existing or future bilateral agreements between the UK and any of the following countries or principalities: Andorra, Monaco, San Marino and the Vatican City State. (c) Arms, ammunitions and war material With respect to Investment liberalisation \u2013 Market access, National treatment, Most favoured nation treatment, Senior management and boards of directors, Performance requirements and Cross-Border Trade in Services \u2013 Market access, Local presence, National treatment, Most favoured nation treatment: Production or distribution of, or trade in, arms, munitions and war material. War material is limited to any product which is solely intended and made for military use in connection with the conduct of war or defence activities. Reservation No. 2 \u2013 Professional services (all professions except health related) Sector\u2013 sub-sector: Professional services - legal services, auditing services Industry classification: Part of CPC 861, part of 87902, part of 862 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Obligations for Legal Services Chapter/ Section: Investment liberalisation, Cross-border trade in services and Regulatory framework for legal services Description: (a) Legal services With respect to Investment liberalisation \u2013 Market access, Senior management and boards of directors, National treatment, Cross-border trade in services \u2013 Market access, Local presence, National treatment and Regulatory framework \u2013 for legal services \u2013 Obligations: The UK reserves the right to adopt or maintain any measure with respect to the supply of legal advisory and legal authorisation, documentation, and certification services provided by legal professionals entrusted with public functions, such as notaries, and with respect to services provided by bailiffs (part of CPC 861, part of 87902). (b) Auditing services (CPC 86211, 86212 other than accounting and bookkeeping services) With respect to Cross-border trade in services \u2013 Market access, Local presence, National treatment: The UK reserves the right to adopt or maintain any measure with respect to the cross-border supply of auditing services. Existing measures: Companies Act 2006 Reservation No. 3 - Professional services (health related and retail of pharmaceuticals) Sector: Health related professional services and retail sales of pharmaceutical, medical and orthopaedic goods, other services provided by pharmacists Industry classification: CPC 63211, 85201, 9312, 9319, 93121 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Medical and dental services; services provided by midwives, nurses, physiotherapists, psychologists and paramedical personnel (CPC 63211, 85201, 9312, 9319) With respect to Investment liberalisation \u2013 Market access: Establishment for doctors under the National Health Service is subject to medical manpower planning (CPC 93121, 93122). With respect to Cross-border trade in services \u2013 Market access, Local presence, National treatment: The supply of all health-related professional services, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, requires residency. These services may only be provided by natural persons physically present in the territory of the UK (CPC 9312, part of 93191). The cross-border supply of medical, dental and midwives services and services provided by nurses, physiotherapists, psychologists and paramedical personnel (part of CPC 85201, 9312, part of 93191). For service suppliers not physically present in the territory of the UK (part of CPC 85201, 9312, part of 93191). (b) Retail sales of pharmaceutical, medical and orthopaedic goods, other services provided by pharmacists (CPC 63211) With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access, Local presence: Mail order is only possible from the UK, thus establishment in the UK is required for the retail of pharmaceuticals and specific medical goods to the general public in the UK. With respect to Cross-border trade in services \u2013 Market access, Local presence, National treatment: The cross-border retail sales of pharmaceuticals and of medical and orthopaedic goods, and other services supplied by pharmacists. Reservation No. 4 \u2013 Business services (collection agency services and credit reporting services) Sector\u2013 sub-sector: Business services - collection agency services, credit reporting services Industry classification: CPC 87901, 87902 Type of reservation: Market access National treatment Local presence Chapter: Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the supply of collection agency services and credit reporting services. Reservation No. 5 \u2013 Business services (placement services) Sector\u2013 sub-sector: Business Services \u2013 placement services Industry classification: CPC 87202, 87204, 87205, 87206, 87209 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: The supply of placement services of domestic help personnel, other commercial or industrial workers, nursing and other personnel (CPC 87204, 87205, 87206, 87209). To require establishment and to prohibit the cross-border supply of placement services of office support personnel and other workers. Reservation No. 6 \u2013 Business services (investigation services) Sector \u2013 sub-sector: Business Services \u2013 investigation services Industry classification: CPC 87301 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the supply of investigation services (CPC 87301). Reservation No. 7 \u2013 Business services (other business services) Sector\u2013 sub-sector: Business services \u2013 other business services Industry classification: CPC 86764, 86769, 8868, part of 8790 Type of reservation: Market access National treatment Most favoured nation treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Maintenance and repair of vessels, rail transport equipment and aircraft and parts thereof (part of CPC 86764, CPC 86769, CPC 8868) With respect to Cross-border trade in services \u2013 Market access, Local presence, National treatment: To require establishment or physical presence in its territory and prohibiting the cross-border supply of maintenance and repair services of rail transport equipment from outside its territory. To require establishment or physical presence in its territory and prohibiting the cross-border supply of maintenance and repair services of internal waterways transport vessels from outside its territory. To require establishment or physical presence in its territory and prohibiting the cross-border supply of maintenance and repair services of maritime vessels from outside its territory. To require establishment or physical presence in its territory and prohibiting the cross-border supply of maintenance and repair services of aircraft and parts thereof from outside its territory (part of CPC 86764, CPC 86769, CPC 8868). Only recognised organisations authorised by the UK may carry out statutory surveys and certification of ships on behalf of the UK. Establishment may be required. Existing measures: Regulation (EC) 391/2009 of the European Parliament and the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations as retained in UK law by the European Union (Withdrawal) Act 2018, and as amended by the Merchant Shipping (Recognised Organisations) (Amendment) (EU Exit) Regulations 2019. (b) Other business services related to aviation With respect to Investment liberalisation - Most favoured nation treatment and Cross-border trade in Services \u2013 Most favoured nation treatment: According differential treatment to a third country pursuant to existing or future bilateral agreements relating to the following services: (i) aircraft repair and maintenance services; (ii) rental or leasing of aircraft without crew; (iii) computer reservation system (CRS) services; (iv) the following services provided using a manned aircraft, subject to compliance with the Parties' respective laws and regulations governing the admission of aircrafts to, departure from and operation within, their territory: aerial fire-fighting, flight training, spraying, surveying, mapping, photography, and other airborne agricultural, industrial and inspection services; and (v) the selling and marketing of air transport services. Reservation No. 8 \u2013 Education services Sector: Education services Industry classification: CPC 92 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: All educational services which receive public funding or State support in any form, and are therefore not considered to be privately funded. Where the supply of privately funded education services by a foreign provider is permitted, participation of private operators in the education system may be subject to the granting of a concession allocated on a non-discriminatory basis. The supply of privately funded other education services, which means other than those classified as being primary, secondary, higher and adult education services (CPC 929). Reservation No. 9 \u2013 Financial services Sector: Financial services Industry classification: Type of reservation: Market access National treatment Most-favoured-nation treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) All financial services With respect to Investment liberalisation \u2013 Market access: To require a financial service supplier, other than a branch, when establishing in the UK to adopt a specific legal form, on a non-discriminatory basis. With respect to Investment liberalisation \u2013 Most favoured nation treatment and Cross-border trade in services \u2013 Most favoured nation treatment: According differential treatment to an investor or a financial services supplier of a third country pursuant to any bilateral or multilateral international investment treaty or other trade agreement. (b) Insurance and insurance-related services With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: For the supply of insurance and insurance-related services except for: (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: \u2014 maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and \u2014 goods in international transit; (ii) Reinsurance and retrocession; and (iii) Services auxiliary to insurance. (c) Banking and other financial services With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Local presence: Only firms having their registered office in the UK can act as depositories of the assets of investment funds. The establishment of a specialised management company, having its head office and registered office in the UK, is required to perform the activities of management of common funds, including unit trusts, and where allowed under national law, investment companies. With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: For the supply of banking and other financial services, except for: (i) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (ii) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point; Reservation No. 10 \u2013 Health and social services Sector: Health and social services Industry classification: CPC 931 other than 9312, part of 93191 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Health services \u2013 hospital, ambulance, residential health services (CPC 931 other than 9312, part of 93191) With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of directors: For the supply of all health services which receive public funding or State support in any form, and are therefore not considered to be privately funded. All privately funded health services other than hospital services. The participation of private operators in the privately funded health network may be subject to concession on a non-discriminatory basis. An economic needs test may apply. Main criteria: number of and impact on existing establishments, transport infrastructure, population density, geographic spread, and creation of new employment. This reservation does not relate to the supply of all health-related professional services, including the services supplied by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, which are covered by other reservations (CPC 931 other than 9312, part of 93191). (b) Health and social services, including pension insurance With respect to Cross-border trade in services \u2013 Market access, Local presence, National treatment: Requiring establishment or physical presence in its territory of suppliers and restricting the cross-border supply of health services from outside its territory, the cross-border supply of social services from outside its territory, as well as activities or services forming part of a public retirement plan or statutory system of social security. This reservation does not relate to the supply of all health-related professional services, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, which are covered by other reservations (CPC 931 other than 9312, part of 93191). (c) Social services, including pension insurance With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements: The supply of all social services which receive public funding or State support in any form, and are therefore not considered to be privately funded, and activities or services forming part of a public retirement plan or statutory system of social security. The participation of private operators in the privately funded social network may be subject to concession on a non-discriminatory basis. An economic needs test may apply. Main criteria: number of and impact on existing establishments, transport infrastructure, population density, geographic spread, and creation of new employment. The supply of privately funded social services other than services relating to convalescent and rest houses and old people's homes. Reservation No. 11 \u2013 Recreational, cultural and sporting services Sector: Recreational, cultural and sporting services Industry classification: CPC 963, 9619, 964 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Libraries, archives, museums and other cultural services (CPC 963) The supply of library, archive, museum and other cultural services. (b) Entertainment services, theatre, live bands and circus services (CPC 9619, 964 other than 96492) The cross-border supply of entertainment services, including theatre, live bands, circus and discotheque services. (c) Gambling and betting services (CPC 96492) The supply of gambling activities, which involve wagering a stake with pecuniary value in games of chance, including in particular lotteries, scratch cards, gambling services offered in casinos, gambling arcades or licensed premises, betting services, bingo services and gambling services operated by and for the benefit of charities or non-profit-making organisations. Reservation No. 12 \u2013 Transport services and auxiliary transport services Sector: Transport services Type of reservation: Market access National treatment Most favoured nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Maritime transport \u2013 any other commercial activity undertaken from a ship With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, Local presence, National treatment: The nationality of the crew on a seagoing or non-seagoing vessel. With respect to Investment liberalisation \u2013 Market access, National treatment, Most favoured nation treatment, Senior management and boards of directors: For the purpose of registering a vessel and operating a fleet under the flag of the UK (all commercial marine activity undertaken from a seagoing ship, including fishing, aquaculture, and services incidental to fishing; international passenger and freight transportation (CPC 721); and services auxiliary to maritime transport). This reservation does not apply to legal persons incorporated in the UK and having an effective and continuous link to its economy. (b) Auxiliary services to maritime transport With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, Local presence, National treatment: The supply of pilotage and berthing services. For greater certainty, regardless of the criteria which may apply to the registration of ships in the UK, the UK reserves the right to require that only ships registered on the national registers of the UK may provide pilotage and berthing services (CPC 7452). Only vessels carrying the flag of the UK may provide pushing and towing services (CPC 7214). (c) Auxiliary services to inland waterways transport With respect to Investment liberalisation \u2013 Market access, National treatment, Most favoured nation treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services \u2013 Market access, Local presence, National treatment, Most favoured nation treatment: Services auxiliary to inland waterways transportation. (d) Rail transport and auxiliary services to rail transport With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-Border Trade in Services \u2013 Market access, Local presence, National treatment: Railway passenger transportation (CPC 7111). With respect to Investment liberalisation \u2013 Market access and Cross-border trade in services \u2013 Market access, Local presence: Railway freight transportation (CPC 7112). (e) Road transport (passenger transportation, freight transportation, international truck transport services) and services auxiliary to road transport With respect to Cross-border trade in services \u2013 Market access, National treatment, Local presence: For road transport services covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement. With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, Local presence, National treatment: For road transport services not covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement: (i) to require establishment and to limit the cross-border supply of road transport services (CPC 712); (ii) an economic needs test may apply to taxi services in the UK setting a limit on the number of service suppliers. Main criteria: Local demand as provided in applicable laws (CPC 71221). Existing measures: Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Licensing of Operators and International Road Haulage (Amendment etc.) (EU Exit) Regulations 2019; Regulation (EC) No 1072/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international road haulage market as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Licensing of Operators and International Road Haulage (Amendment etc.) (EU Exit) Regulations 2019; and Regulation (EC) No 1073/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international market for coach and bus services, and amending Regulation (EC) No 561/2006 as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Common Rules for Access to the International Market for Coach and Bus Services (Amendment etc.) (EU Exit) Regulations 2019. (f) Space transport and rental of space craft With respect to Investment Liberalisation \u2013 Market access, National treatment, Performance requirements, Senior management and boards of directors and Cross-border trade in services \u2013 Market access, Local presence, National treatment: Transportation services via space and the rental of space craft (CPC 733, part of 734). (g) Most-favoured-nation exemptions With respect to Investment liberalisation \u2013 Most favoured nation treatment, and Cross-border trade in services \u2013 Most favoured nation treatment: (i) Road and rail transport To accord differential treatment to a country pursuant to existing or future bilateral agreements relating to international road haulage (including combined transport \u2013 road or rail) and passenger transport, concluded between the UK and a third country (CPC 7111, 7112, 7121, 7122, 7123). That treatment may: \u2014 reserve or limit the supply of the relevant transport services between the contracting parties or across the territory of the contracting parties to vehicles registered in each contracting party; or \u2014 provide for tax exemptions for such vehicles. (ii) Air transport - Services auxiliary to air transport According differential treatment to a third country pursuant to existing or future bilateral agreements relating to ground-handling services. Reservation No. 13 \u2013 Fishing and water Sector: Fishing, aquaculture, services incidental to fishing; collection, purification and distribution of water Industry classification: ISIC Rev. 3.1 0501, 0502, CPC 882, ISIC Rev. 3.1 41 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Fishing, aquaculture and services incidental to fishing (ISIC Rev. 3.1 0501, 0502, CPC 882) With respect to Investment liberalisation \u2013 Market access, National treatment, Senior management and boards of directors, Performance requirements, Most favoured nation treatment and Cross-border trade in services \u2013 Market access, National treatment, Local presence, Most favoured nation treatment: 1. In particular within the framework of United Kingdom fisheries policy, and of fishing agreements with a third country, access to and use of biological resources and fishing grounds situated in the maritime waters coming under the sovereignty or jurisdiction of the United Kingdom, or entitlements for fishing under a United Kingdom fishing licence, including: (a) regulating the landing of catches by vessels flying the flag of a Member State or a third country with respect to the quotas allocated to them or, only with respect to vessels flying the flag of the United Kingdom, requiring that a proportion of the total catch is landed in United Kingdom ports; (b) determining a minimum size for a company in order to preserve both artisanal and coastal fishing vessels; (c) according differential treatment pursuant to existing or future international agreements relating to fisheries; and (d) requiring the crew of a vessel flying the flag of the United Kingdom to be United Kingdom nationals. 2. A fishing vessel\u2019s entitlement to fly the flag of the United Kingdom only if: (a) it is wholly owned by: (i) companies incorporated in the United Kingdom; or (ii) United Kingdom nationals; (b) its day-to-day operations are directed and controlled from within the United Kingdom; and (c) any charterer, manager or operator of the vessel is a company incorporated in the United Kingdom or a United Kingdom national. 3. A commercial fishing licence granting the right to fish in the territorial waters of the United Kingdom may only be granted to vessels flying the flag of the United Kingdom. 4. The establishment of marine or inland aquaculture facilities. 5. Point (a), (b), (c) (other than with respect to most-favoured nation treatment) and (d) of paragraph 1, point (a)(i), point (b) and (c) of paragraph 2 and paragraph 3 only apply to measures which are applicable to vessels or to enterprises irrespective of the nationality of their beneficial owners. (b) Collection, purification and distribution of water With respect to Investment liberalisation \u2013 Market access, National treatment and Cross-border trade in services \u2013 Market access, Local presence, National treatment: For activities, including services relating to the collection, purification and distribution of water to household, industrial, commercial or other users, including the supply of drinking water, and water management. Reservation No. 14 \u2013 Energy related activities Sector: Production of energy and related services Industry classification: ISIC Rev. 3.1 401, 402, CPC 7131, CPC 887 (other than advisory and consulting services). Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure, where the UK permits foreign ownership of a gas or electricity transmission system, or an oil and gas pipeline transport system, with respect to enterprises of the Union controlled by natural persons or enterprises of a third country which accounts for more than 5 per cent of the UK's oil, natural gas or electricity imports, in order to guarantee the security of the energy supply of the UK. This reservation does not apply to advisory and consultancy services provided as services incidental to energy distribution. Reservation No. 15 \u2013 Other services not included elsewhere Sector: Other services not included elsewhere Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the provision of new services other than those classified in the United Nations Provisional Central Product Classification (CPC), 1991. (1) Regulation (EC) No 391/2009 of the European Parliament and the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations (OJ EU L 131 28.5.2009, p. 11). (2) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ EU L 302, 17.11.2009, p. 32). (3) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ EU L 174, 1.7.2011, p. 1). (4) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ EU L 343 14.12.2012, p. 32). (5) Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC (OJ EU L 300, 14.11.2009, p. 51). (6) Regulation (EC) No 1072/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international road haulage market (OJ EU L 300, 14.11.2009, p. 72). (7) Regulation (EC) No 1073/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international market for coach and bus services, and amending Regulation (EC) No 561/2006 (OJ EU L 300 14.11.2009, p. 88). (8) With regard to Austria the part of the most-favoured-nation treatment exemption regarding traffic rights covers all countries with whom bilateral agreements on road transport or other arrangements relating to road transport exist or may be considered in future. (9) Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU (OJ EU L 158, 14.6.2019, p. 125). (10) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ EU L 211, 14.8.2009, p. 94). (11) Directive 96/92/EC of the European Parliament and of the Council of 19 December 1996 concerning common rules for the internal market in electricity (OJ EU L 27, 30.1.1997, p. 20). (12) Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity and repealing Directive 96/92/EC (OJ EU L 176, 15.7.2003, p. 37). (13) Directive 98/30/EC of the European Parliament and the Council of 22 June 1998 concerning common rules for the internal market in natural gas (OJ EU L 204, 21.7.1998, p. 1). ANNEX 21 BUSINESS VISITORS FOR ESTABLISHMENT PURPOSES, INTRA-CORPORATE TRANSFEREES AND SHORT-TERM BUSINESS VISITORS 1. A measure listed in this Annex may be maintained, continued, promptly renewed, or amended, provided that the amendment does not decrease the conformity of the measure with Articles 141 and 142 of this Agreement, as it existed immediately before the amendment. 2. Articles 141 and 142 of this Agreement do not apply to any existing non-conforming measure listed in this Annex, to the extent of the non-conformity. 3. The schedules in paragraphs 6, 7 and 8 apply only to the territories of the United Kingdom and the Union in accordance with Article 520(2) and Article 774 of this Agreement and are only relevant in the context of trade relations between the Union and its Member States with the United Kingdom. They do not affect the rights and obligations of the Member States under Union law. 4. For greater certainty, for the Union, the obligation to grant national treatment does not entail the requirement to extend to natural or legal persons of the United Kingdom the treatment granted in a Member State, in application of the Treaty on the Functioning of the European Union, or of any measure adopted pursuant to that Treaty, including their implementation in the Member States, to: (i) natural persons or residents of another Member State; or (ii) legal persons constituted or organised under the law of another Member State or of the Union and having their registered office, central administration or principal place of business in the Union. 5. The following abbreviations are used in the paragraphs below: AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czechia DE Germany DK Denmark EE Estonia EL Greece ES Spain EU European Union, including all its Member States FI Finland FR France HR Croatia HU Hungary IE Ireland IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta NL The Netherlands PL Poland PT Portugal RO Romania SE Sweden SI Slovenia SK Slovak Republic 6. The Union's non-conforming measures are: Business visitors for establishment purposes All sectors AT, CZ: Business visitor for establishment purposes needs to work for an enterprise other than a non-profit organisation, otherwise: Unbound. SK: Business visitor for establishment purposes needs to work for an enterprise other than a non-profit organisation, otherwise: Unbound. Work permit required, including economic needs test. CY: Permissible length of stay: up to 90 days in any twelve month period. Business visitor for establishment purposes needs to work for an enterprise other than a non-profit organisation, otherwise: Unbound. Intra-corporate transferees All sectors EU: Until 31 December 2022 any charge, fee or tax imposed by a Party (other than fees associated with the processing of a visa, work permit, or residency permit application or renewal) on the grounds of being allowed to perform an activity or to hire a person who can perform such activity in the territory of a Party, unless it is a requirement consistent with Article 140(3) of this Agreement, or a health fee under national legislation in connection with an application for a permit to enter, stay, work, or reside in the territory of a Party. AT, CZ, SK: Intra-corporate transferees need to be employed by an enterprise other than a non-profit organisation, otherwise: Unbound. FI: Senior personnel needs to be employed by an enterprise other than a non-profit organisation. HU: Natural persons who have been a partner in an enterprise do not qualify to be transferred as intra-corporate transferees. Short-term business visitors All activities referred to in paragraph 8: CY, DK, HR: Work permit, including economic needs test, required in case the short-term business visitor supplies a service. LV: Work permit required for operations/activities to be performed on the basis of a contract. MT: Work permit required. No economic needs tests performed. SI: A single residency and work permit is required for the supply of services exceeding 14 days at a time and for certain activities (research and design; training seminars; purchasing; commercial transactions; translation and interpretation). An economic needs test is not required. SK: In case of supplying a service in the territory of Slovakia, a work permit, including economic needs test, is required beyond seven days in a month or 30 days in calendar year. Research and design AT: Work permit, including economic needs test, required, except for research activities of scientific and statistical researchers. Marketing research AT: Work permit required, including economic needs test. Economic needs test is waived for research and analysis activities for up to seven days in a month or 30 days in a calendar year. University degree required. CY: Work permit required, including economic needs test. Trade fairs and exhibitions AT, CY: Work permit, including economic needs test, required for activities beyond seven days in a month or 30 days in a calendar year. After-sales or after-lease service AT: Work permit required, including economic needs test. Economic needs test is waived for natural persons training workers to supply services and possessing specialisedge knowledge. CY, CZ : Work permit is required beyond seven days in a month or 30 days in calendar year. ES: Installers, repair and maintainers should be employed as such by the legal person supplying the good or service or by an enterprise which is a member of the same group as the originating legal person for at least three months immediately preceding the date of submission of an application for entry and they should possess at least 3 years of relevant professional experience, where applicable, obtained after the age of majority. FI: Depending on the activity, a residence permit may be required. SE: Work permit required, except for (i) natural persons who participate in training, testing, preparation or completion of deliveries, or similar activities within the framework of a business transaction, or (ii) fitters or technical instructors in connection with urgent installation or repair of machinery for up to two months, in the context of an emergency. No economic needs test required. Commercial transactions AT, CY: Work permit, including economic needs test, required for activities beyond seven days in a month or 30 days in a calendar year. FI: The natural person needs to be supplying services as an employee of a legal person of the other Party. Tourism personnel CY, ES, PL: Unbound. FI: The natural person needs to be supplying services as an employee of a legal person of the other Party. SE: Work permit required, except for drivers and staff of tourist buses. No economic needs test required. Translation and interpretation AT: Work permit required, including economic needs test. CY, PL: Unbound. 7. The United Kingdom's non-conforming measures are: Business visitors for establishment purposes All sectors Business visitor for establishment purposes needs to work for an enterprise other than a non-profit organisation, otherwise: Unbound. Intra-corporate transferees All sectors Intra-corporate transferees need to be employed by an enterprise other than a non-profit organisation, otherwise: Unbound. Until 31 December 2022 any charge, fee or tax imposed by a Party (other than fees associated with the processing of a visa, work permit, or residency permit application or renewal) on the grounds of being allowed to perform an activity or to hire a person who can perform such activity in the territory of a Party, unless it is a requirement consistent with Article 140(3) of this Agreement, or a health fee under national legislation in connection with an application for a permit to enter, stay, work, or reside in the territory of a Party. Short-term business visitors All activities referred to in paragraph 8: None 8. The activities Short-term business visitors are permitted to engage in are: (a) meetings and consultations: natural persons attending meetings or conferences, or engaged in consultations with business associates; (b) research and design: technical, scientific and statistical researchers conducting independent research or research for a legal person of the Party of which the Short-term business visitor is a natural person; (c) marketing research: market researchers and analysts conducting research or analysis for a legal person of the Party of which the Short-term business visitor is a natural person; (d) training seminars: personnel of an enterprise who enter the territory being visited by the Short-term business visitor to receive training in techniques and work practices which are utilised by companies or organisations in the territory being visited by the Short-term business visitor, provided that the training received is confined to observation, familiarisation and classroom instruction only; (e) trade fairs and exhibitions: personnel attending a trade fair for the purpose of promoting their company or its products or services; (f) sales: representatives of a supplier of services or goods taking orders or negotiating the sale of services or goods or entering into agreements to sell services or goods for that supplier, but not delivering goods or supplying services themselves. Short-term business visitors shall not engage in making direct sales to the general public; (g) purchasing: buyers purchasing goods or services for an enterprise, or management and supervisory personnel, engaging in a commercial transaction carried out in the territory of the Party of which the Short-term business visitor is a natural person; (h) after-sales or after-lease service: installers, repair and maintenance personnel and supervisors, possessing specialised knowledge essential to a seller's contractual obligation, supplying services or training workers to supply services pursuant to a warranty or other service contract incidental to the sale or lease of commercial or industrial equipment or machinery, including computer software, purchased or leased from a legal person of the Party of which the Short-term business visitor is a natural person throughout the duration of the warranty or service contract; (i) commercial transactions: management and supervisory personnel and financial services personnel (including insurers, bankers and investment brokers) engaging in a commercial transaction for a legal person of the Party of which the Short-term business visitor is a natural person; (j) tourism personnel: tour and travel agents, tour guides or tour operators attending or participating in conventions or accompanying a tour that has begun in the territory of the Party of which the Short-term business visitor is a natural person; and (k) translation and interpretation: translators or interpreters supplying services as employees of a legal person of the Party of which the Short-term business visitor is a natural person. ANNEX 22 CONTRACTUAL SERVICE SUPPLIERS AND INDEPENDENT PROFESSIONALS 1. Each Party shall allow the supply of services in its territory by contractual service suppliers or independent professionals of the other Party through the presence of natural persons, in accordance with Article 143 of this Agreement, for the sectors listed in this Annex and subject to the relevant limitations. 2. The list below is composed of the following elements: (a) the first column indicating the sector or sub-sector for which the category of contractual service suppliers and independent professionals is liberalised; and (b) the second column describing the applicable limitations. 3. In addition to the list of reservations in this Annex, each Party may adopt or maintain a measure relating to qualification requirements, qualification procedures, technical standards, licensing requirements or licensing procedures that does not constitute a limitation within the meaning of Article 143 of this Agreement. These measures, which include requirements to obtain a licence, obtain recognition of qualifications in regulated sectors or to pass specific examinations, such as language examinations, even if not listed in this Annex, apply in any case to contractual service suppliers or independent professionals of the Parties. 4. The Parties do not undertake any commitment for contractual service suppliers and independent professionals in economic activities which are not listed. 5. In identifying individual sectors and sub-sectors: CPC means the Central Products Classification as set out in Statistical Office of the United Nations, Statistical Papers, Series M, N\u00b0 77, CPC prov., 1991. 6. In the sectors where economic needs tests are applied, their main criteria will be the assessment of: (a) for the United Kingdom, the relevant market situation in the United Kingdom; and (b) for the Union, the relevant market situation in the Member State or the region where the service is to be provided, including with respect to the number of, and the impact on, services suppliers who are already supplying a service when the assessment is made. 7. The schedules in paragraphs 10 to 13 apply only to the territories of the United Kingdom and the Union in accordance with Article 520(2) and Article 774 of this Agreement and are only relevant in the context of trade relations between the Union and its Member States with the United Kingdom. They do not affect the rights and obligations of the Member States under Union law. 8. For greater certainty, for the Union, the obligation to grant national treatment does not entail the requirement to extend to natural or legal persons of the United Kingdom the treatment granted in a Member State, in application of the Treaty on the Functioning of the European Union, or of any measure adopted pursuant to that Treaty, including their implementation in the Member States, to: (i) natural persons or residents of another Member State; or (ii) legal persons constituted or organised under the law of another Member State or of the Union and having their registered office, central administration or principal place of business in the Union. 9. The following abbreviations are used in the lists below: AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czechia DE Germany DK Denmark EE Estonia EL Greece ES Spain EU European Union, including all its Member States FI Finland FR France HR Croatia HU Hungary IE Ireland IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta NL The Netherlands PL Poland PT Portugal RO Romania SE Sweden SI Slovenia SK Slovak Republic CSS Contractual Service Suppliers IP Independent Professionals Contractual Service Suppliers 10. Subject to the list of reservations in paragraphs 12 and 13, the Parties take commitments in accordance with Article 143 of this Agreement with respect to the mode 4 category of Contractual Service Suppliers in the following sectors or sub-sectors: (a) Legal advisory services in respect of public international law and home jurisdiction law; (b) Accounting and bookkeeping services; (c) Taxation advisory services; (d) Architectural services and urban planning and landscape architectural services; (e) Engineering services and integrated engineering services; (f) Medical and dental services; (g) Veterinary services; (h) Midwives services; (i) Services provided by nurses, physiotherapists and paramedical personnel; (j) Computer and related services; (k) Research and development services; (l) Advertising services; (m) Market research and opinion polling; (n) Management consulting services; (o) Services related to management consulting; (p) Technical testing and analysis services; (q) Related scientific and technical consulting services; (r) Mining; (s) Maintenance and repair of vessels; (t) Maintenance and repair of rail transport equipment; (u) Maintenance and repair of motor vehicles, motorcycles, snowmobiles and road transport equipment; (v) Maintenance and repair of aircrafts and parts thereof; (w) Maintenance and repair of metal products, of (non office) machinery, of (non transport and non office) equipment and of personal and household goods; (x) Translation and interpretation services; (y) Telecommunication services; (z) Postal and courier services; (aa) Construction and related engineering services; (bb) Site investigation work; (cc) Higher education services; (dd) Services relating to agriculture, hunting and forestry; (ee) Environmental services; (ff) Insurance and insurance related services advisory and consulting services; (gg) Other financial services advisory and consulting services; (hh) Transport advisory and consulting services; (ii) Travel agencies and tour operators' services; (jj) Tourist guides services; (kk) Manufacturing advisory and consulting services. Independent Professionals 11. Subject to the list of reservations in paragraphs 12 and 13, the Parties take commitments in accordance with Article 143 of this Agreement with respect to the mode 4 category of Independent Professionals in the following sectors or sub-sectors: (a) Legal advisory services in respect of public international law and home jurisdiction law; (b) Architectural services and urban planning and landscape architectural services; (c) Engineering services and integrated engineering services; (d) Computer and related services; (e) Research and development services; (f) Market research and opinion polling; (g) Management consulting services; (h) Services related to management consulting; (i) Mining; (j) Translation and interpretation services; (k) Telecommunication services; (l) Postal and courier services (m) Higher education services; (n) Insurance related services advisory and consulting services; (o) Other financial services advisory and consulting services; (p) Transport advisory and consulting services; (q) Manufacturing advisory and consulting services. 12. The Union's reservations are: Sector or sub-sector Description of reservations All sectors CSS and IP: In AT: Maximum stay shall be for a cumulative period of not more than six months in any 12 month period or for the duration of the contract, whichever is less. In CZ: Maximum stay shall be for a period of not more than 12 consecutive months or for the duration of the contract, whichever is less. Legal advisory services in respect of public international law and home jurisdiction law (part of CPC 861) CSS: In AT, BE, CY, DE, EE, EL, ES, FR, HR, IE, IT, LU, NL, PL, PT, SE: None. In BG, CZ, DK, FI, HU, LT, LV, MT, RO, SI, SK: Economic needs test. IP: In AT, CY, DE, EE, FR, HR, IE, LU, LV, NL, PL, PT, SE: None. In BE, BG, CZ, DK, EL, ES, FI, HU, IT, LT, MT, RO, SI, SK: Economic needs tests. Accounting and bookkeeping services (CPC 86212 other than \"auditing services\", 86213, 86219 and 86220) CSS: In AT, BE, DE, EE, ES, HR, IE, IT, LU, NL, PL, PT, SI, SE: None. In BG, CZ, CY, DK, EL, FI, FR, HU, LT, LV, MT, RO, SK: Economic needs test. IP: EU: Unbound. Taxation advisory services (CPC 863) (1) CSS: In AT, BE, DE, EE, ES, FR, HR, IE, IT, LU, NL, PL, SI, SE: None. In BG, CZ, CY, DK, EL, FI, HU, LT, LV, MT, RO, SK: Economic needs test. In PT: Unbound. IP: EU: Unbound. Architectural services and Urban planning and landscape architectural services (CPC 8671 and 8674) CSS: In BE, CY, EE, ES, EL, FR, HR, IE, IT, LU, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In BG, CZ, DE, HU, LT, LV, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In AT: Planning services only, where: Economic needs test. IP: In CY, DE, EE, EL, FR, HR, IE, LU, LV, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In BE, BG, CZ, DK, ES, HU, IT, LT, RO, SK: Economic needs test. In AT: Planning services only, where: Economic needs test. Engineering services and Integrated engineering services (CPC 8672 and 8673) CSS: In BE, CY, EE, ES, EL, FR, HR, IE, IT, LU, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In BG, CZ, DE, HU, LT, LV, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In AT: Planning services only, where: Economic needs test. IP: In CY, DE, EE, EL, FR, HR, IE, LU, LV, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In BE, BG, CZ, DK, ES, HU, IT, LT, RO, SK: Economic needs test. In AT: Planning services only, where: Economic needs test. Medical (including psychologists) and dental services (CPC 9312 and part of 85201) CSS: In SE: None. In CY, CZ, DE, DK, EE, ES, IE, IT, LU, MT, NL, PL, PT, RO, SI: Economic needs test. In FR: Economic needs test, except for psychologists, where: Unbound. In AT: Unbound, except for psychologists and dental services, where: Economic needs test. In BE, BG, EL, FI, HR, HU, LT, LV, SK: Unbound. IP: EU: Unbound. Veterinary services (CPC 932) CSS: In SE: None. In CY, CZ, DE, DK, EE, EL, ES, FI, FR, IE, IT, LT, LU, MT, NL, PL, PT, RO, SI: Economic needs test. In AT, BE, BG, HR, HU, LV, SK: Unbound. IP: EU: Unbound. Midwives services (part of CPC 93191) CSS: In IE, SE: None. In AT, CY, CZ, DE, DK, EE, EL, ES, FR, IT, LT, LV, LU, MT, NL, PL, PT, RO, SI: Economic needs test. In BE, BG, FI, HR, HU, SK: Unbound. IP: EU: Unbound. Services provided by nurses, physiotherapists and paramedical personnel (part of CPC 93191) CSS: In IE, SE: None. In AT, CY, CZ, DE, DK, EE, EL, ES, FR, IT, LT, LV, LU, MT, NL, PL, PT, RO, SI: Economic needs test. In BE, BG, FI, HR, HU, SK: Unbound. IP: EU: Unbound. Computer and related services (CPC 84) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LU, LV, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test except for CSS stays of up to three months. IP: In DE, EE, EL, FR, IE, LU, LV, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In AT, BE, BG, CZ, CY, DK, ES, HU, IT, LT, RO, SK: Economic needs test. In HR: Unbound. Research and development Services (CPC 851, 852 excluding psychologists services (2), and 853) CSS: EU except in NL, SE: A hosting agreement with an approved research organisation is required (3). EU except in CZ, DK, SK: None In CZ, DK, SK: Economic needs test. IP: EU except in NL, SE: A hosting agreement with an approved research organisation is required (4). EU except in BE, CZ, DK, IT, SK: None In BE, CZ, DK, IT, SK: Economic needs test. Advertising services (CPC 871) CSS: In BE, DE, EE, ES, FR, HR, IE, IT, LU, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DK, EL, FI, HU, LT, LV, MT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Market research and opinion polling services (CPC 864) CSS: In BE, DE, EE, ES, FR, IE, IT, LU, NL, PL, SE: None. In AT, BG, CZ, CY, DK, EL, FI, HR, LV, MT, RO, SI, SK: Economic needs test. In PT: None, except for public opinion polling services (CPC 86402), where: Unbound. In HU, LT: Economic needs test, except for public opinion polling services (CPC 86402), where: Unbound. IP: In DE, EE, FR, IE, LU, NL, PL, SE: None. In AT, BE, BG, CZ, CY, DK, EL, ES, FI, HR, IT, LV, MT, RO, SI, SK: Economic needs test. In PT: None, except for public opinion polling services (CPC 86402), where: Unbound. In HU, LT: Economic needs test, except for public opinion polling services (CPC 86402), where: Unbound. Management consulting services (CPC 865) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In CY, DE, EE, EL, FI, FR, IE, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, DK, ES, HR, HU, IT, LT, RO, SK: Economic needs test. Services related to management consulting (CPC 866) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In HU: Economic needs test, except for arbitration and conciliation services (CPC 86602), where: Unbound. IP: In CY, DE, EE, EL, FI, FR, IE, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, DK, ES, HR, IT, LT, RO, SK: Economic needs test In HU: Economic needs test, except for arbitration and conciliation services (CPC 86602), where: Unbound. Technical testing and analysis services (CPC 8676) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LU, NL, PL, SI, SE: None. In AT, BG, CZ, CY, FI, HU, LT, LV, MT, PT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: EU: Unbound, except NL. In NL: None. Related scientific and technical consulting services (CPC 8675) CSS: In BE, EE, EL, ES, HR, IE, IT, LU, NL, PL, SI, SE: None. In AT, CZ,CY, DE, DK, FI, HU, LT, LV, MT, PT, RO, SK: Economic needs test. In DE: None, except for publicly appointed surveyors, where: Unbound. In FR: None, except for \"surveying\" operations relating to the establishment of property rights and to land law, where: Unbound. In BG: Unbound. IP: EU: Unbound, except NL. In NL: None. Mining (CPC 883, advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ,CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In DE, EE, EL, FI, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, HU, IT, LT, PL, RO, SK: Economic needs test. Maintenance and repair of vessels (part of CPC 8868) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, NL, PL, PT, SI, SE: None In AT, BG, CZ, CY, DE, DK, FI, HU, IE, LT, MT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Maintenance and repair of rail transport equipment (part of CPC 8868) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, FI, HU, IE, LT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Maintenance and repair of motor vehicles, motorcycles, snowmobiles and road transport equipment (CPC 6112, 6122, part of 8867 and part of 8868) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, FI, HU, IE, LT, MT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Maintenance and repair of aircraft and parts thereof (part of CPC 8868) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, FI, HU, IE, LT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Maintenance and repair of metal products, of (non office) machinery, of (non transport and non office) equipment and of personal and household goods (5) (CPC 633, 7545, 8861, 8862, 8864, 8865 and 8866) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, HU, IE, LT, RO, SK: Economic needs test. In FI: Unbound, except in the context of an after-sales or after-lease contract; for maintenance and repair of personal and household goods (CPC 633): Economic needs test. IP: EU: Unbound, except NL. In NL: None. Translation and interpretation services (CPC 87905, excluding official or certified activities) CSS: In BE, CY, DE, EE, EL, ES, FR, HR, IT, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, DK, FI, HU, IE, LT, LV, RO, SK: Economic needs test. IP: In CY, DE, EE, FR, LU, LV, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, DK, EL, ES, FI, HU, IE, IT, LT, RO, SK: Economic needs test. In HR: Unbound. Telecommunication services (CPC 7544, advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In DE, EE, EL, FI, FR, HR, IE, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, HU, IT, LT, RO, SK: Economic needs test. Postal and courier services (CPC 751, advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, FI, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In DE, EE, EL, FR, HR, IE, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, FI, HU, IT, LT, RO, SK: Economic needs test. Construction and related engineering services (CPC 511, 512, 513, 514, 515, 516, 517 and 518. BG: CPC 512, 5131, 5132, 5135, 514, 5161, 5162, 51641, 51643, 51644, 5165 and 517) CSS: EU: Unbound except in BE, CZ, DK, ES, NL and SE. In BE, DK, ES, NL, SE: None. In CZ: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Site investigation work (CPC 5111) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ,CY, FI, HU, LT, LV, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: EU: Unbound. Higher education services (CPC 923) CSS: EU except in LU, SE: Unbound. In LU: Unbound, except for university professors, where: None. In SE: None, except for publicly funded and privately funded educational services suppliers with some form of State support, where: Unbound. IP: EU except in SE: Unbound. In SE: None, except for publicly funded and privately funded educational services suppliers with some form of State support, where: Unbound. Agriculture, hunting and forestry (CPC 881, advisory and consulting services only) CSS: EU except in BE, DE, DK, ES, FI, HR and SE: Unbound In BE, DE, ES, HR, SE: None In DK: Economic needs test. In FI: Unbound, except for advisory and consulting services relating to forestry, where: None. IP: EU: Unbound. Environmental services (CPC 9401, 9402, 9403, 9404, part of 94060, 9405, part of 9406 and 9409) CSS: In BE, EE, ES, FI, FR, HR, IE, IT, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, EL, HU, LT, LV, RO, SK: Economic needs test. IP: EU: Unbound. Insurance and insurance related services (advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ,CY, FI, LT, RO, SK: Economic needs test. In DK: Economic needs test except for CSS stays of up to three months. In HU: Unbound. IP: In DE, EE, EL, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, FI, IT, LT, PL, RO, SK: Economic needs test. In HU: Unbound. Other financial services (advisory and consulting services only) CSS: In BE, DE, ES, EE, EL, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, FI, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS that stays of up to three months. In HU: Unbound. IP: In DE, EE, EL, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, FI, IT, LT, PL, RO, SK: Economic needs test. In HU: Unbound. Transport (CPC 71, 72, 73, and 74, advisory and consulting services only) CSS: In DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In BE: Unbound. IP: In CY, DE, EE, EL, FI, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BG, CZ, DK, ES, HU, IT, LT, RO, SK: Economic needs test. In PL: Economic needs test, except for air transport, where: None. In BE: Unbound. Travel agencies and tour operators services (including tour managers (6)) (CPC 7471) CSS: In AT, CY, CZ, DE, EE, ES, FR, HR, IT, LU, NL, PL, SI, SE: None. In BG, EL, FI, HU, LT, LV, MT, PT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In BE, IE: Unbound, except for tour managers, where: None. IP: EU: Unbound. Tourist guides services (CPC 7472) CSS: In NL, PT, SE: None. In AT, BE, BG, CY, CZ, DE, DK, EE, FI, FR, EL, HU, IE, IT, LV, LU, MT, RO, SK, SI: Economic needs test. In ES, HR, LT, PL: Unbound. IP: EU: Unbound. Manufacturing (CPC 884, and 885, advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In DE, EE, EL, FI, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, HU, IT, LT, PL, RO, SK: Economic needs test. 13. The United Kingdom's reservations are: Sector or sub-sector Description of reservations All sectors None Legal advisory services in respect of public international law and home jurisdiction law (part of CPC 861) CSS: None. IP: None. Accounting and bookkeeping services (CPC 86212 other than \"auditing services\", 86213, 86219 and 86220) CSS: None. IP: Unbound. Taxation advisory services (CPC 863) (7) CSS: None. IP: Unbound. Architectural services and Urban planning and landscape architectural services (CPC 8671 and 8674) CSS: None. IP: None. Engineering services and Integrated engineering services (CPC 8672 and 8673) CSS: None. IP: None. Medical (including psychologists) and dental services (CPC 9312 and part of 85201) CSS: Unbound. IP: Unbound. Veterinary services (CPC 932) CSS: Unbound. IP: Unbound. Midwives services (part of CPC 93191) CSS: Unbound. IP: Unbound. Services provided by nurses, physiotherapists and paramedical personnel (part of CPC 93191) CSS: Unbound. IP: Unbound. Computer and related services (CPC 84) CSS: UK: None. IP: None. Research and development Services (CPC 851, 852 excluding psychologists services (8), and 853) CSS: None IP: None Advertising services (CPC 871) CSS: None. IP: Unbound. Market research and opinion polling services (CPC 864) CSS: None. IP: None. Management consulting services (CPC 865) CSS: None. IP: None. Services related to management consulting (CPC 866) CSS: None. IP: None. Technical testing and analysis services (CPC 8676) CSS: None. IP: Unbound. Related scientific and technical consulting services (CPC 8675) CSS: None. IP: Unbound. Mining (CPC 883, advisory and consulting services only) CSS: None. IP: None. Maintenance and repair of vessels (part of CPC 8868) CSS: None IP: Unbound. Maintenance and repair of rail transport equipment (part of CPC 8868) CSS: None. IP: Unbound. Maintenance and repair of motor vehicles, motorcycles, snowmobiles and road transport equipment (CPC 6112, 6122, part of 8867 and part of 8868) CSS: None. IP: Unbound. Maintenance and repair of aircraft and parts thereof (part of CPC 8868) CSS: None. IP: Unbound. Maintenance and repair of metal products, of (non office) machinery, of (non transport and non office) equipment and of personal and household goods (9) (CPC 633, 7545, 8861, 8862, 8864, 8865 and 8866) CSS: None. IP: Unbound. Translation and interpretation services (CPC 87905, excluding official or certified activities) CSS: None. IP: None. Telecommunication services (CPC 7544, advisory and consulting services only) CSS: None. IP: None. Postal and courier services (CPC 751, advisory and consulting services only) CSS: None. IP: None. Construction and related engineering services (CPC 511, 512, 513, 514, 515, 516, 517 and 518. BG: CPC 512, 5131, 5132, 5135, 514, 5161, 5162, 51641, 51643, 51644, 5165 and 517) CSS: Unbound. IP: Unbound. Site investigation work (CPC 5111) CSS: None. IP: Unbound. Higher education services (CPC 923) CSS: Unbound. IP: Unbound. Agriculture, hunting and forestry (CPC 881, advisory and consulting services only) CSS: Unbound IP: Unbound. Environmental services (CPC 9401, 9402, 9403, 9404, part of 94060, 9405, part of 9406 and 9409) CSS: None. IP: Unbound. Insurance and insurance related services (advisory and consulting services only) CSS: None. IP: None. Other financial services (advisory and consulting services only) CSS: None. IP: None. Transport (CPC 71, 72, 73, and 74, advisory and consulting services only) CSS: None. IP: None. Travel agencies and tour operators services (including tour managers (10)) (CPC 7471) CSS: None. IP: Unbound. Tourist guides services (CPC 7472) CSS: None. IP: Unbound. Manufacturing (CPC 884, and 885, advisory and consulting services only) CSS: None. IP: None. (1) Does not include legal advisory and legal representational services on tax matters, which are under legal advisory services in respect of public international law and home jurisdiction law. (2) Part of CPC 85201, which is under medical and dental services. (3) For all Member States except DK, the approval of the research organisation and the hosting agreement must meet the conditions set pursuant to EU Directive 2005/71/EC of 12 October 2005. (4) For all Member States except DK, the approval of the research organisation and the hosting agreement must meet the conditions set pursuant to EU Directive 2005/71/EC of 12 October 2005. (5) Maintenance and repair services of office machinery and equipment including computers (CPC 845) are under computer services. (6) Services suppliers whose function is to accompany a tour group of a minimum of 10 natural persons, without acting as guides in specific locations. (7) Does not include legal advisory and legal representational services on tax matters, which are under legal advisory services in respect of public international law and home jurisdiction law. (8) Part of CPC 85201, which is under medical and dental services. (9) Maintenance and repair services of office machinery and equipment including computers (CPC 845) are under computer services. (10) Services suppliers whose function is to accompany a tour group of a minimum of 10 natural persons, without acting as guides in specific locations. ANNEX 23 MOVEMENT OF NATURAL PERSONS Article 1 Entry and temporary stay-related procedural commitments The Parties shall endeavour to ensure that the processing of applications for entry and temporary stay pursuant to their respective commitments in the Agreement follows good administrative practice: (a) Each Party shall ensure that fees charged by competent authorities for the processing of applications for entry and temporary stay do not unduly impair or delay trade in services under this Agreement; (b) subject to the discretion of the competent authorities of each Party, documents required from an applicant for applications for the grant of entry and temporary stay of short-term visitors for business purposes should be commensurate with the purpose for which they are collected; (c) complete applications for the grant of entry and temporary stay shall be processed by the competent authorities of each Party as expeditiously as possible; (d) the competent authorities of each Party shall endeavour to provide, without undue delay, information in response to any reasonable request from an applicant concerning the status of an application; (e) if the competent authorities of a Party require additional information from an applicant in order to process the application, they shall endeavour to notify, without undue delay, the applicant; (f) the competent authorities of each Party shall notify the applicant of the outcome of the application promptly after a decision has been taken; (g) if an application is approved, the competent authorities of each Party shall notify the applicant of the period of stay and other relevant terms and conditions; (h) if an application is denied, the competent authorities of a Party shall, upon request or upon their own initiative make available to the applicant information on any available review and appeal procedures; and (i) each Party shall endeavour to accept and process applications in electronic format. Article 2 Additional procedural commitments applying to intra-corporate transferees and their partner, children and family members (1) 1. The competent authorities of each Party shall adopt a decision on an application for an intra-corporate transferee entry or temporary stay or a renewal thereof and notify the decision to the applicant in writing, in accordance with the notification procedures under national law, as soon as possible but not later than 90 days after the date on which the complete application was submitted. 2. Where the information or documentation supplied in support of the application is incomplete, the competent authorities concerned shall endeavour to notify the applicant within a reasonable period of the additional information that is required and set a reasonable deadline for providing it. The period referred to in paragraph 1 shall be suspended until the competent authorities have received the additional information required. 3. The Union shall extend to family members of natural persons of the United Kingdom, who are intra-corporate transferees to the Union, the right of entry and temporary stay granted to family members of an intra-corporate transferee under Article 19 of Directive 2014/66/EU of the European Parliament and of the Council (2). 4. The United Kingdom shall allow the entry and temporary stay of partners and dependent children of intra-corporate transferees, as allowed under the United Kingdom's Immigration Rules. 5. The United Kingdom shall allow the partners and dependent children of intra-corporate transferees referred to in paragraph 4 to work for the duration of their visa, in an employed or self-employed capacity, and shall not require them to obtain a work permit. (1) Paragraphs 1, 2 and 3 do not apply to the Member States that are not subject to the application of Directive 2014/66/EU of the European Parliament and of the Council of 15 May 2014 on the conditions of entry and residence of third-country nationals in the framework of an intra- corporate transfer (OJ EU L 157, 27.5.2014, p. 1) (the \"ICT Directive\"). (2) Directive 2014/66/EU of the European Parliament and of the Council of 15 May 2014 on the conditions of entry and residence of third- country nationals in the framework of an intra-corporate transfer (OJ EU L 157, 27.5.2014, p. 1). ANNEX 24 GUIDELINES FOR ARRANGEMENTS ON THE RECOGNITION OF PROFESSIONAL QUALIFICATIONS SECTION A GENERAL PROVISIONS Introduction 1. This Annex contains guidelines for arrangements on the conditions for the recognition of professional qualifications (\"arrangements\"), as foreseen by Article 158 of this Agreement. 2. Pursuant to Article 158 of this Agreement, these guidelines shall be taken into account in the development of joint recommendations by professional bodies or authorities of the Parties (\"joint recommendations\"). 3. The guidelines are non-binding, non-exhaustive and do not modify or affect the rights and obligations of the Parties under this Agreement. They set out the typical content of arrangements, and provide general indications as to the economic value of an arrangement and the compatibility of the respective professional qualifications regimes. 4. Not all elements of these guidelines may be relevant in all cases and professional bodies and authorities are free to include in their joint recommendations any other element that they consider pertinent for the arrangements of the profession and the professional activities concerned, consistent with this Agreement. 5. The guidelines should be taken into account by the Partnership Council when deciding whether to develop and adopt arrangements. They are without prejudice to its review of the consistency of joint recommendations with Title II of Heading One of Part Two of this Agreement and its discretion to take into account the elements it deems relevant, including those contained in joint recommendations. SECTION B FORM AND CONTENT OF AN ARRANGEMENT 6. This section sets out the typical content of an arrangement, some of which is not within the remit of the professional bodies or authorities preparing joint recommendations. These aspects constitute, nonetheless, useful information to be taken into account in the preparation of joint recommendations, so that they are better adapted to the possible scope of an arrangement. 7. Matters addressed specifically in this Agreement which apply to arrangements (such as the geographical scope of an arrangement, its interaction with scheduled non-conforming measures, the system of dispute resolution, appeal mechanisms, monitoring and review mechanisms of the arrangement) should not be addressed by joint recommendations. 8. An arrangement may specify different mechanisms for the recognition of professional qualifications within a Party. It may also be limited, but not necessarily so, to setting the scope of the arrangement, the procedural provisions, the effects of recognition and additional requirements, and the administrative arrangements. 9. An arrangement which is adopted by the Partnership Council should reflect the degree of discretion that is intended to be preserved for competent authorities deciding on recognition. Scope of an Arrangement 10. The arrangement should set out: (a) the specific regulated profession(s), relevant professional title(s) and the activity or group of activities covered by the scope of practice of the regulated profession in both Parties (\"scope of practice\"); and (b) whether it covers the recognition of professional qualifications for the purpose of access to professional activities on a fixed-term or an indefinite basis. Conditions for recognition 11. The arrangement may specify in particular: (a) the professional qualifications necessary for recognition under the arrangement (for example, evidence of formal qualification, professional experience, or other attestation of competence); (b) the degree of discretion preserved by recognition authorities when assessing requests for recognition of these qualifications; and (c) the procedures to deal with variations and gaps between professional qualifications and means to bridge the differences, including the possibility for imposing any compensatory measures or any other relevant conditions and limitations. Procedural provisions 12. The arrangement may set out: (a) the documents required and the form in which they should be presented (for example, by electronic or other means, whether they should be supported by translations or certifications of authenticity, etc.); (b) the steps and procedures in the recognition process, including those relating to possible compensatory measures, corresponding obligations and timelines; and (c) the availability of information relevant to all aspects of the recognition processes and requirements. Effects of recognition and additional requirements 13. The arrangement may set out provisions on the effects of recognition (if relevant, also in respect of different modes of supply). 14. The arrangement may describe any additional requirements for the effective exercise of the regulated profession in the host Party. Such requirements may include: (a) registration requirements with local authorities; (b) appropriate language skills; (c) proof of good character; (d) compliance with the requirements of the host Party for use of trade or firm names; (e) compliance with the rules of ethics, independence and professional conduct requirements of the host Party; (f) need to obtain professional indemnity insurance; (g) rules on disciplinary action, financial responsibility and professional liability; and (h) requirements for continuous professional development. Administration of the arrangement 15. The arrangement should set out the terms under which it can be reviewed or revoked, and the effects of any revision or revocation. Consideration may also be given to the inclusion of provisions concerning the effects of any recognition previously accorded. SECTION C ECONOMIC VALUE OF AN ENVISAGED ARRANGEMENT 16. Pursuant to Article 158(2) of this Agreement, joint recommendations shall be supported by an evidence-based assessment of the economic value of an envisaged arrangement. This may consist of an evaluation of the economic benefits that an arrangement is expected to bring to the economies of both Parties. Such an assessment may assist the Partnership Council when developing and adopting an arrangement. 17. Aspects such as the existing level of market openness, industry needs, market trends and developments, client expectations and requirements and business opportunities would constitute useful elements. 18. The evaluation is not required to be a full and detailed economic analysis, but should provide an explanation of the interest of the profession in, and the expected benefits for the Parties ensuing from, the adoption of an arrangement. SECTION D COMPATIBILITY OF RESPECTIVE PROFESSIONAL QUALIFICATION REGIMES 19. Pursuant to Article 158(2) of this Agreement, joint recommendations shall be supported by an evidence-based assessment of the compatibility of the respective professional qualification regimes. This assessment may assist the Partnership Council when developing and adopting an arrangement. 20. The following process aims at guiding professional bodies and authorities when assessing the compatibility of the respective professional qualifications and activities with a view to simplifying and facilitating the recognition of professional qualifications. Step One: Assessment of the scope of practice and the professional qualifications required to practise the regulated profession in each Party. 21. The assessment of the scope of practice and of the professional qualifications required to practise a regulated profession in each of the Parties should be based on all relevant information. 22. The following elements should be identified: (a) activities or groups of activities covered by the scope of practice of the regulated profession in each Party; and (b) the professional qualifications required in each Party to practise the regulated profession, which may include any of the following elements: (i) the minimum education required, for example, entry requirements, level of education, length of study and contents of study; (ii) the minimum professional experience required, for example, location, length and conditions of practical training or supervised professional practice prior to registration, licensing or equivalent; (iii) examinations passed, especially examinations of professional competency; and (iv) the acquisition of a licence, or equivalent, certifying, inter alia, the fulfilment of the necessary professional qualification requirements for the pursuit of the profession. Step Two: Evaluation of the divergence between the scope of practice of, or the professional qualifications required to practise, the regulated profession in each Party. 23. The evaluation of the divergence in the scope of practice of, or in the professional qualifications required to practise, the regulated profession, in each Party, should in particular identify divergence that is substantial. 24. Substantial divergence in the scope of practice may exist if all of the following conditions are met: (a) one or more activities covered by a regulated profession in the host Party are not covered by the corresponding profession in the Party of origin; (b) such activities are subject to specific training in the host Party; (c) the training for such activities in the host Party covers matters substantially diverging from those covered by the applicant's qualification. 25. Substantial divergence in the professional qualifications required to practise a regulated profession may exist if there are divergences in the Parties' requirements with regard to the level, duration or content of the training that is required for the pursuit of activities covered by the regulated profession. Step Three: Recognition mechanisms 26. There may be different mechanisms for the recognition of professional qualifications, depending on the circumstances. There may be different mechanisms within a Party. 27. If there is no substantial divergence in the scope of practice and in the professional qualifications required to practise a regulated profession, an arrangement may provide for a simpler, more streamlined recognition process than would be the case where substantial divergence exists. 28. If there is substantial divergence, the arrangement may provide for compensatory measures which are sufficient to remedy such divergence. 29. Where compensatory measures are used to reduce substantial divergence, they should be proportionate to the divergence that they seek to address. Any practical professional experience or formally validated training could be taken into account to assess the extent of the compensatory measures needed. 30. Whether or not the divergence is substantial, the arrangement may take account of the degree of discretion that is intended to be preserved for competent authorities deciding on recognition requests. 31. Compensatory measures may take different forms, including: (a) a period of supervised practice of a regulated profession in the host Party, possibly accompanied by further training, under the responsibility of a qualified person and subject to a regulated assessment; (b) a test made or recognised by the relevant authorities of the host Party to assess the applicant's ability to practice a regulated profession in that Party; or (c) a temporary limitation of the scope of practice; or a combination of those. 32. The arrangement could envisage that a choice be given to applicants between different compensatory measures where this could limit the administrative burden for applicants and such measures are equivalent. ANNEX 25 PUBLIC PROCUREMENT SECTION A RELEVANT PROVISIONS OF THE GPA Articles I to III, IV.1.a, IV.2 to IV.7, VI to XV, XVI.1 to XVI.3, XVII and XVIII. SECTION B: MARKET ACCESS COMMITMENTS For the purposes of this Section, \"CPC\" means the Provisional Central Product Classification (Statistical Papers, Series M No. 77, Department of International Economic and Social Affairs, Statistical Office of the United Nations, New York, 1991). SUB-SECTION B1 European Union In accordance with Article 277(2) and (3) of this Agreement, Title VI of Heading One of Part Two of this Agreement applies, in addition to the procurement covered by the annexes of the European Union to Appendix I to the GPA, to the procurement covered by this Sub-section. The Notes in Annexes 1 to 7 of the European Union to Appendix I to the GPA also apply to the procurement covered by this Sub-section, unless otherwise provided for in this Sub-section. Procurement covered by this Sub-section 1. Additional procuring entities Procurement of goods and services as set out in Annexes 4 to 6 of the European Union to Appendix I to the GPA, and in paragraph 2 of this Sub-section, by the following procuring entities of the Member States: (a) all contracting entities whose procurement is covered by Directive 2014/25/EU of the European Parliament and of the Council (1) (the \"EU Utilities Directive\") which are contracting authorities (e.g. those covered under Annex 1 and Annex 2 to Appendix I to the GPA) or public undertakings (2) and which have as one of their activities: (i) the provision or operation of fixed networks intended to provide a service to the public in connection with the production, transport or distribution of gas or heat or the supply of gas or heat to such networks; or (ii) any combination between such activity and those referred to in Annex 3 to Appendix I to the GPA; (b) privately-owned procuring entities that have as one of their activities any of those referred to in point (a) of this paragraph, in point 1 of Annex 3 to Appendix I to the GPA, or any combination thereof and operate on the basis of special or exclusive rights granted by a competent authority of a Member State; with regard to procurement equal to or above the following thresholds: \u2014 400 000 SDR for procurement of goods and services, \u2014 5 000 000 SDR for procurement of construction services (CPC 51). 2. Additional services Procurement of the following services, in addition to the services listed under Annex 5 of the European Union to Appendix I to the GPA, for entities covered under Annexes 1 to 3 of the European Union to Appendix I to the GPA or under paragraph 1 of this Sub-section: \u2014 Hotel and restaurant services (CPC 641); \u2014 Food serving services (CPC 642); \u2014 Beverage serving services (CPC 643); \u2014 Telecommunication related services (CPC 754); \u2014 Real estate services on a fee or contract basis (CPC 8220); \u2014 Other business services (CPC 87901, 87903, 87905-87907); \u2014 Education services (CPC 92). Notes: 1. Hotel and restaurant services (CPC 641), food serving services (CPC 642), beverage serving services (CPC 643) and education services (CPC 92) contracts are included under the national treatment regime for the suppliers, including service providers, of the United Kingdom, provided that their value equals or exceeds EUR 750 000 when they are awarded by procuring entities covered under Annexes 1 and 2 of the European Union to Appendix I to the GPA and that their value equals or exceeds EUR 1 000 000 when they are awarded by procuring entities covered under Annex 3 of the European Union to Appendix I to the GPA or by procuring entities covered by paragraph 1 of this Sub-section. 2. The supply of gas or heat to networks which provide a service to the public by a procuring entity other than a contracting authority shall not be considered as an activity within the meaning of this Sub-section where: (a) the production of gas or heat by the entity concerned takes place because its consumption is necessary for carrying out an activity other than that referred to in this Sub-section or in paragraphs (a) to (f) of Annex 3 of the European Union to Appendix I to the GPA; and (b) the supply to the public network is aimed only at the economic exploitation of such production and amounts to not more than 20 % of the entity's turnover on the basis of the average for the preceding three years, including the current year. 3. Title VI of Heading One of Part Two of this Agreement and this Annex do not cover procurement of the following services: (a) Human health services (CPC 931); (b) Administrative healthcare services (CPC 91122); and (c) Supply services of nursing personnel and supply services of medical personnel (CPC 87206 and CPC 87209). SUB-SECTION B2 United Kingdom In accordance with Article 277 (2) and (3) of this Agreement, Title VI of Heading One of Part Two of this Agreement applies, in addition to the procurement covered by Article II of the GPA, to the procurement covered by this Sub-section. The Notes in Annexes 1 to 7 of the United Kingdom to Appendix I to the GPA also apply to the procurement covered by this Sub-section, unless otherwise provided for in this Sub-section. Procurement covered by this Sub-section 1. Additional procuring entities Procurement of goods and services as set out in Annexes 4 to 6 of the United Kingdom's Appendix I to the GPA, and in paragraph 2 of this Sub-section, by the following procuring entities of the United Kingdom: (a) all contracting entities whose procurement is covered by the Utilities Contracts Regulation 2016 and the Utilities Contracts (Scotland) Regulations 2016 which are contracting authorities (e.g. those covered under Annex 1 and Annex 2 to Appendix I to the GPA) or public undertakings (see Note:1) and which have as one of their activities: (i) the provision or operation of fixed networks intended to provide a service to the public in connection with the production, transport or distribution of gas or heat or the supply of gas or heat to such networks; or (ii) any combination between such activity and those referred to in Annex 3 to Appendix I to the GPA; (b) privately-owned procuring entities that have as one of their activities any of those referred to in point (a) of this paragraph, in point 1 of Annex 3 to Appendix I to the GPA, or any combination thereof and operate on the basis of special or exclusive rights granted by a competent authority of the United Kingdom; with regard to procurement equal to or above the following thresholds: \u2014 400 000 SDR for procurement of goods and services, \u2014 5 000 000 SDR for procurement of construction services (CPC 51). Notes to paragraph 1: 1. According to the Utilities Contracts Regulations 2016, a \"public undertaking\" means any undertaking over which contracting authorities may exercise directly or indirectly a dominant influence by virtue of: (a) their ownership of that undertaking; (b) their financial participation in that undertaking; or (c) the rules which govern that undertaking. 2. According to the Utilities Contracts (Scotland) Regulations 2016, a \"public undertaking\" means a person over which one or more contracting authorities are able to exercise, directly or indirectly, a dominant influence by virtue of one or more of the following: (a) their ownership of that person; (b) their financial participation in that person; (c) the rights accorded to them by the rules which govern that person. 3. According to both the Utilities Contracts Regulations 2016 and the Utilities Contracts (Scotland) Regulations 2016, a dominant influence on the part of contracting authorities is presumed in any of the following cases in which those authorities, directly or indirectly: (a) hold the majority of the undertaking's subscribed capital; (b) control the majority of the votes attaching to shares issued by the undertaking; (c) can appoint more than half of the undertaking's administrative, management or supervisory body. 2. Additional services Procurement of the following services, in addition to the services listed under Annex 5 of the United Kingdom to Appendix I to the GPA, for entities covered under Annexes 1 to 3 of the United Kingdom to Appendix I to the GPA or under paragraph 1 of this Sub-section: \u2014 Hotel and restaurant services (CPC 641); \u2014 Food serving services (CPC 642); \u2014 Beverage serving services (CPC 643); \u2014 Telecommunication related services (CPC 754); \u2014 Real estate services on a fee or contract basis (CPC 8220); \u2014 Other business services (CPC 87901, 87903, 87905-87907); \u2014 Education services (CPC 92). Notes: 1. Hotel and restaurant services (CPC 641), food serving services (CPC 642), beverage serving services (CPC 643) and education services (CPC 92) contracts are included under the national treatment regime for the suppliers, including service providers, of the European Union, provided that their value equals or exceeds GBP 663 540 when they are awarded by procuring entities covered under Annexes 1 and 2 of the United Kingdom to Appendix I to the GPA and that their value equals or exceeds GBP 884 720 when they are awarded by procuring entities covered under Annex 3 of the United Kingdom to Appendix I to the GPA or by procuring entities covered by paragraph 1 of this Section. 2. The supply of gas or heat to networks which provide a service to the public by a procuring entity other than a contracting authority shall not be considered as an activity within the meaning of this Section where: (a) the production of gas or heat by the entity concerned takes place because its consumption is necessary for carrying out an activity other than that referred to in this Section or in paragraphs (a) to (f) of Annex 3 of the United Kingdom to Appendix I to the GPA; and (b) the supply to the public network is aimed only at the economic exploitation of such production and amounts to not more than 20 % of the entity's turnover on the basis of the average for the preceding three years, including the current year. 3. Title VI of Heading One of Part Two of this Agreement and this Annex do not cover procurement of the following services: (a) Human health services (CPC 931); (b) Administrative healthcare services (CPC 91122); and (c) Supply services of nursing personnel and supply services of medical personnel (CPC 87206 and CPC 87209). (1) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ EU L 94 28.3.2014, p. 243). (2) According to the EU Utilities Directive, a public undertaking is any undertaking over which the contracting authorities may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the contracting authorities shall be presumed when these authorities, directly or indirectly, in relation to an undertaking: (i) hold the majority of the undertaking's subscribed capital, (ii) control the majority of the votes attaching to shares issued by the undertaking, or (iii) can appoint more than half of the undertaking's administrative, management or supervisory body. ANNEX 26 LISTS OF ENERGY GOODS, HYDROCARBONS AND RAW MATERIALS LIST OF ENERGY GOODS BY HS CODE \u2014 Natural gas, including liquefied natural gas, liquefied petroleum gas (LPG) (HS code 27.11) \u2014 Electrical energy (HS code 27.16) \u2014 Crude oil and oil products (HS code 27.09 - 27.10, 27.13-27.15) \u2014 Solid fuels (HS code 27.01, HS code 27.02, HS code 27.04) \u2014 Fuel wood and wood charcoal (HS code 44.01 and HS code 44.02 goods used for energy) \u2014 Biogas (HS code 38.25) LIST OF HYDROCARBONS BY HS CODE \u2014 Crude oil (HS code 27.09) \u2014 Natural gas (HS code 27.11) LIST OF RAW MATERIALS BY HS CHAPTER Chapter Heading 25 Salt; sulphur; earths and stone; plastering materials, lime and cement 26 Ores, slag and ash, with the exception of uranium or thorium ores or concentrates (HS code 26.12) 27 Mineral fuels, mineral oils and products of their distillation; bituminous substances; mineral waxes 28 Inorganic chemicals; organic or inorganic compounds of precious metals, of rare-earth metals; of radioactive elements or of isotopes, with the exception of radioactive chemical elements and radioactive isotopes (including the fissile or fertile chemical elements and isotopes) and their compounds; mixtures and residues containing these products (HS code 28.44); and isotopes other than those of heading no. 28.44; compounds, inorganic or organic, of such isotopes, whether or not chemically defined (HS code 28.45) 29 Organic chemicals 31 Fertilisers 71 Natural or cultured pearls, precious or semi-precious stones, precious metals, metals clad with precious metal, and articles thereof, with the exception of pearls, natural or cultured, whether or not worked or graded but not strung, mounted or set; pearls, natural or cultured, temporarily strung for the convenience of transport (HS code 7101) 72 Iron and steel 74 Copper and articles thereof 75 Nickel and articles thereof 76 Aluminium and articles thereof 78 Lead and articles thereof 79 Zinc and articles thereof 80 Tin and articles thereof 81 Other base metals; cermets; articles thereof ANNEX 27 ENERGY AND ENVIRONMENTAL SUBSIDIES As part of the principles set out in Article 367(14) of this Agreement: (1) Subsidies for electricity generation adequacy, renewable energy and cogeneration shall not undermine the ability of a Party to meet its obligations under Article 304 of this Agreement, shall not unnecessarily affect the efficient use of electricity interconnectors provided for under Article 311 of this Agreement, and, without prejudice to Article 304(3) of this Agreement, shall be determined by means of a transparent, non-discriminatory and effective competitive process; and (a) subsidies for electricity generation adequacy shall provide incentives for capacity providers to be available in times of expected system stress and may be limited to installations not exceeding specified CO2 emission limits; and (b) subsidies for renewable energy and cogeneration shall not affect beneficiaries\u2019 obligations or opportunities to participate in electricity markets. (2) Notwithstanding point 1, provided that appropriate measures are put in place to prevent overcompensation, non-competitive procedures may be used to grant subsidies for renewable energy and cogeneration if the potential supply is insufficient to ensure a competitive process, the eligible capacity is unlikely to have a material effect on trade or investment between the Parties, or subsidies are granted for demonstration projects. (3) If partial exemptions from energy-related taxes and levies (1) in favour of energy-intensive users are introduced, such exemptions shall not exceed the total amount of the tax or levy. (4) If compensation for electricity-intensive users is granted in the event of an increase in electricity cost resulting from climate policy instruments, it shall be restricted to sectors at significant risk of carbon leakage due to the cost increase. (5) Subsidies for the decarbonisation of emissions linked to own industrial activities shall achieve an overall reduction in greenhouse gas emissions. The subsidies shall reduce the emissions directly resulting from the industrial activity. Subsidies for improvements of the energy efficiency of own industrial activities shall improve energy efficiency by reducing energy consumption, either directly or per unit of production. (1) For greater certainty, levies do not include network charges or tariffs. ANNEX 28 NON-APPLICATION OF THIRD-PARTY ACCESS AND OWNERSHIP UNBUNDLING TO INFRASTRUCTURE A Party may decide not to apply Articles 306 and 307 of this Agreement to new infrastructure or to a significant expansion of existing infrastructure where: (a) the risk attached to the investment in the infrastructure is such that the investment would not take place unless an exemption is granted; (b) the investment enhances competition or security of supply; (c) the infrastructure is owned by a natural or legal person separate, at least in terms of its legal form, from the system operators in whose systems it was or is to be built; (d) before granting the exemption, the Party has decided on the rules and mechanisms for management and allocation of capacity. ANNEX 29 ALLOCATION OF ELECTRICITY INTERCONNECTOR CAPACITY AT THE DAY-AHEAD MARKET TIMEFRAME PART 1 1. The new procedure for the allocation of capacity on electricity interconnectors at the day-ahead market timeframe shall be based on the concept of \"Multi-region loose volume coupling\". The overall objective of the new procedure shall be to maximise the benefits of trade. As the first step in developing the new procedure, the Parties shall ensure that transmission system operators prepare outline proposals and a cost-benefit analysis. 2. Multi-region loose volume coupling shall involve the development of a market coupling function to determine the net energy positions (implicit allocation) between: (a) bidding zones established in accordance with Regulation (EU) 2019/943, which are directly connected to the United Kingdom by an electricity interconnector; and (b) the United Kingdom. 3. The net energy positions over electricity interconnectors shall be calculated via an implicit allocation process by applying a specific algorithm to: (a) commercial bids and offers for the day-ahead market timeframe from the bidding zones established in accordance with Regulation (EU) 2019/943 which are directly connected to the United Kingdom by an electricity interconnector; (b) commercial bids and offers for the day-ahead market timeframe from relevant day-ahead markets in the United Kingdom; (c) network capacity data and system capabilities determined in accordance with the procedures agreed between transmission system operators; and (d) data on expected commercial flows of electricity interconnections between bidding zones connected to the United Kingdom and other bidding zones in the Union, as determined by Union transmission system operators using robust methodologies. This process shall be compatible with the specific characteristics of direct current electricity interconnectors, including losses and ramping requirements. 4. The market coupling function shall: (a) produce results sufficiently in advance of the operation of the Parties' respective day-ahead markets (for the Union this is single day-ahead coupling established in accordance with Commission Regulation (EU) 2015/1222 (1)) in order that such results may be used as inputs into the processes which determine the results in those markets; (b) produce results which are reliable and repeatable; (c) be a specific process to link the distinct and separate day-ahead markets in the Union and the United Kingdom; in particular, this means that the specific algorithm shall be distinct and separate from that used in single day-ahead coupling established in accordance with Regulation (EU) 2015/1222 and, in respect of commercial bids and offers of the Union, only have access to those from bidding zones which are directly connected to the United Kingdom by an electricity interconnector. 5. The calculated net energy positions shall be published following validation and verification. If the market coupling function is unable either to operate or to produce a result, electricity interconnector capacity shall be allocated by a fall-back process, and market participants shall be notified that the fall-back process will apply. 6. The costs of developing and implementing the technical procedures shall be equally shared between the relevant United Kingdom transmission system operators or other entities, on the one side, and relevant Union transmission system operators or other entities, on the other side, unless the Specialised Committee on Energy decides otherwise. PART 2 The timeline for the implementation of this Annex shall be from the entry into force of this Agreement, as follows: (a) within 3 months \u2013 cost benefit analysis and outline of proposals for technical procedures; (b) within 10 months \u2013 proposal for technical procedures; (c) within 15 months \u2013 entry into operation of technical procedures. (1) Commission Regulation (EU) 2015/1222 of 24 July 2015 establishing a guideline on capacity allocation and congestion management (OJ EU L 197, 25.7.2015, p. 24). ANNEX 30 AIRWORTHINESS AND ENVIRONMENT CERTIFICATION SECTION A GENERAL PROVISIONS Article 1 Purpose and scope 1. The objective of this Annex is the implementation of cooperation in the following areas, in accordance with Article 445(2) of this Agreement, describing the terms, conditions and methods for reciprocal acceptance of findings of compliance and certificates: (a) airworthiness certificates and monitoring of civil aeronautical products referred to in point (a) of Article 445(1) of this Agreement; (b) environmental certificates and testing of civil aeronautical products referred to in point (b) of Article 445(1) of this Agreement; and (c) design and production certificates and monitoring of design and production organisations referred to in point (c) Article 445(1) of this Agreement. 2. Notwithstanding paragraph 1, used civil aeronautical products, other than used aircraft, are excluded from the scope of this Annex. Article 2 Definitions For the purposes of this Annex, the following definitions apply: (a) \"acceptance\" means the recognition of certificates, approvals, changes, repairs, documents and data of one Party by the other Party without validation activities and without issuing a corresponding certificate by that other Party; (b) \"authorised release certificate\" means a certificate issued by an approved organisation or a competent authority of the exporting Party as a form of recognition that a new civil aeronautical product, other than an aircraft, conforms to a design approved by the exporting Party and is in a condition for safe operation; (c) \"category of civil aeronautical products\" means a set of products sharing common characteristics, as grouped in the technical implementation procedures, on the basis of EASA and UK CAA Certification Specifications; (d) \"certificating authority\" means the technical agent of the exporting Party that issues a design certificate for a civil aeronautical product in its capacity as an authority carrying out the State of Design responsibilities set out in Annex 8 to the Convention on International Civil Aviation. When a design certificate is issued by an approved organisation of the exporting Party, the technical agent of the exporting Party is considered as the certificating authority; (e) \"design certificate\" means a form of recognition by the technical agent or an approved organisation of a Party that the design or change to a design of a civil aeronautical product complies with airworthiness requirements, as applicable, and environmental protection requirements, in particular concerning environmental characteristics set out in laws, regulations and administrative provisions of that Party; (f) \"design-related operational requirements\" means the operational, including environmental, requirements affecting either the design features of the civil aeronautical product or data on the design relating to the operations, or the maintenance of that product, which make it eligible for a particular kind of operation; (g) \"export\" means the process by which a civil aeronautical product is released from the regulatory system for civil aviation safety of a Party to that of the other Party; (h) \"export certificate of airworthiness\" means a certificate issued by the competent authority of the exporting Party or, for used aircraft, by the competent authority of the State of Registry from which the product is exported as a form of recognition that an aircraft conforms to the applicable airworthiness and environmental protection requirements notified by the importing Party; (i) \"exporting Party\" means the Party from whose regulatory system for civil aviation safety a civil aeronautical product is released; (j) \"import\" means the process by which an exported civil aeronautical product from the regulatory system for civil aviation safety of a Party is introduced into that of the other Party; (k) \"importing Party\" means the Party into whose regulatory system for civil aviation safety a civil aeronautical product is introduced; (l) \"major change\" means all changes in type design other than \"minor change\"; (m) \"minor change\" means a change in type design that has no appreciable effect on the mass, balance, structural strength, reliability, operational characteristics, environmental characteristics, or other characteristics affecting the airworthiness of the civil aeronautical product; (n) \"operational suitability data\" means the required set of data to support and allow the type specific operational aspects of certain types of aircraft that are regulated under the regulatory system for civil aviation safety of the Union or of the United Kingdom. It must be designed by the type certificate applicant or holder for the aircraft and be part of the type certificate. Under the regulatory system for civil aviation safety of the Union or of the United Kingdom, an initial application for a type certificate or restricted type certificate shall include, or be subsequently supplemented by, the application for approval of operational suitability data, as applicable to the aircraft type; (o) \"production approval\" means a certificate issued by the competent authority of a Party to a manufacturer which produces civil aeronautical products, as a form of recognition that the manufacturer complies with applicable requirements set out in laws, regulations and administrative provisions of that Party for the production of the particular civil aeronautical products; (p) \"technical implementation procedures\" means the implementation procedures for this Annex developed by the technical agents of the Parties in accordance with Article 445(5) of this Agreement; (q) \"validating authority\" means the technical agent of the importing Party that accepts or validates, as specified in this Annex, a design certificate issued by the certificating authority. SECTION B CERTIFICATION OVERSIGHT BOARD Article 3 Establishment and composition 1. The Certification Oversight Board, accountable to the Specialised Committee on Aviation Safety, is hereby established under the co-chairmanship of the technical agents of the Parties, as a technical coordination body responsible for the effective implementation of this Annex. It shall be composed of representatives from the technical agent of each Party and may invite additional participants to facilitate the fulfilment of its mandate. 2. The Certification Oversight Board shall meet at regular intervals upon the request of either technical agent, and take decisions and make recommendations by consensus. It shall develop and adopt its rules of procedure. Article 4 Mandate The mandate of the Certification Oversight Board shall include in particular: (a) developing, adopting, and revising the technical implementation procedures referred to in Article 6; (b) sharing information on major safety concerns and, where appropriate, developing action plans to address them; (c) resolving technical issues falling within the responsibilities of the competent authorities and affecting the implementation of this Annex; (d) where appropriate, developing effective means of cooperation, technical support and exchange of information regarding safety and environmental protection requirements, certification systems, and quality management and standardisation systems; (e) conducting periodic reviews on the modalities of validation or acceptance of design certificates set out in Articles 10 and 13; (f) proposing amendments to this Annex to the Specialised Committee on Aviation Safety; (g) in accordance with Article 29, defining procedures to ensure the continued confidence of each Party in the reliability of the other Party's processes for findings of compliance; (h) analysing and taking action regarding the implementation of the procedures referred to in point (g); and (i) reporting unresolved issues to the Specialised Committee on Aviation Safety and ensuring the implementation of decisions taken by the Specialised Committee on Aviation Safety regarding this Annex. SECTION C IMPLEMENTATION Article 5 Competent authorities for design certification, production certification and export Certificates 1. The competent authorities for design certification are: (a) for the Union: the European Union Aviation Safety Agency; and (b) for the United Kingdom: the Civil Aviation Authority of the United Kingdom. 2. The competent authorities for production certification and export certificates are: (a) for the Union: the European Union Aviation Safety Agency and the competent authorities of the Member States. As regards an export certificate for used aircraft, it is the competent authority of the State of Registry for the aircraft from which the aircraft is exported; and (b) for the United Kingdom: the Civil Aviation Authority of the United Kingdom. Article 6 Technical implementation procedures 1. The technical implementation procedures shall be developed by the technical agents of the Parties through the Certification Oversight Board in order to provide specific procedures to facilitate the implementation of this Annex, by defining the procedures for communication activities between the competent authorities of the Parties. 2. The technical implementation procedures shall also address the differences between the Parties' civil aviation standards, rules, practices, procedures and systems related to the implementation of this Annex, as provided for in Article 445(5) of this Agreement. Article 7 Exchange and protection of confidential and proprietary data and information 1. Data and information exchanged in the implementation of this Annex shall be subject to Article 453 of this Agreement. 2. Data and information exchanged during the validation process shall be limited in nature and content to what is necessary for the purpose of compliance demonstration with applicable technical requirements, as detailed in the technical implementation procedures. 3. Any disagreement with regard to a data and information exchange between the competent authorities shall be handled as detailed in the technical implementation procedures. Each Party shall retain the right to refer the disagreement to the Certification Oversight Board for resolution. SECTION D DESIGN CERTIFICATION Article 8 General principles 1. This Section addresses all design certificates and changes thereto, where applicable, within the scope of this Annex, in particular: (a) type certificates, including restricted type certificates; (b) supplemental type certificates; (c) repair design approvals; and (d) technical standard order authorisations. 2. The validating authority shall either validate, having regard to the level of involvement referred to in Article 12, or accept a design certificate or a change that has been, or is in the process of being, issued or approved by the certificating authority, in accordance with the terms and conditions set out in this Annex and as detailed in the technical implementation procedures, including its modalities of acceptance and validation of certificates. 3. For the implementation of this Annex, each Party shall ensure that, in its regulatory system for civil aviation safety, the capability of any design organisation to assume its responsibilities is sufficiently controlled through a system of certification for design organisations. Article 9 Validation process 1. An application for the validation of a design certificate of a civil aeronautical product shall be made to the validating authority through the certificating authority as detailed in the technical implementation procedures. 2. The certificating authority shall ensure that the validating authority receives all the relevant data and information necessary for the validation of the design certificate, as detailed in the technical implementation procedures. 3. Upon receiving the application for the validation of the design certificate, the validating authority shall determine the certification basis for the validation in accordance with Article 11, as well as the level of involvement of the validating authority in the validation process in accordance with Article 12. 4. The validating authority shall, as detailed in the technical implementation procedures, base its validation to the maximum extent practicable on the technical evaluations, tests, inspections, and findings of compliance made by the certificating authority. 5. The validating authority shall, after examining relevant data and information provided by the certificating authority, issue its design certificate for the validated civil aeronautical product (\"validated design certificate\") when: (a) it is confirmed that the certificating authority has issued its own design certificate for the civil aeronautical product; (b) it has been stated by the certificating authority that the civil aeronautical product complies with the certification basis referred to in Article 11; (c) all issues raised during the validation process conducted by the validating authority have been resolved; and (d) additional administrative requirements, as detailed in the technical implementation procedures, have been met by the applicant. 6. Each Party shall ensure that in order to obtain and maintain a validated design certificate, the applicant holds and retains at the disposal of the certificating authority all relevant design information, drawings and test reports, including inspection records for the certified civil aeronautical product, in order to provide the information necessary to ensure the continued airworthiness and compliance with applicable environmental protection requirements of the civil aeronautical product. Article 10 Modalities of the validation of design certificates 1. Type certificates issued by the technical agent of the Union as certificating authority shall be validated by the technical agent of the United Kingdom as validating authority. The following data shall be subject to acceptance: (a) engine installation manual (for engine type certificate); (b) structural repair manual; (c) instruction for continued airworthiness of electrical wiring interconnection systems; and (d) weight balance manual. By way of technical implementation procedures, procedural detail may be established in respect of acceptance of the relevant data. Any such procedural detail must not affect the requirement of acceptance established in the first subparagraph. 2. Significant supplemental type certificates and approvals for significant major changes issued by the technical agent of the Union as certificating authority shall be validated by the technical agent of the United Kingdom as validating authority. A streamlined validation process limited to the technical familiarisation without the involvement of the validating authority in the showing of compliance activities by the applicant shall be used as a matter of principle, unless otherwise decided by the technical agents on a case-by-case basis. 3. Type certificates issued by the technical agent of the United Kingdom as certificating authority shall be validated by the technical agent of the Union as validating authority. 4. Supplemental type certificates, approvals for major changes, major repairs and technical standard order authorisations issued by the technical agent of the United Kingdom as certificating authority or by an approved organisation under laws and regulations of the United Kingdom shall be validated by the technical agent of the Union as validating authority. A streamlined validation process limited to the technical familiarisation without the involvement of the validating authority in the showing of compliance activities by the applicant may be used when decided by the technical agents on a case-by-case basis. Article 11 Certification basis for the validation 1. For the purpose of validating a design certificate of a civil aeronautical product, the validating authority shall refer to the following requirements set out in laws, regulations and administrative provisions of its Party in determining the certification basis: (a) the airworthiness requirements for a similar civil aeronautical product that were in effect on the effective application date established by the certificating authority, and complemented when applicable by additional technical conditions as detailed in the technical implementation procedures; and (b) the environmental protection requirements for the civil aeronautical product that were in effect on the date of the application for the validation to the validating authority. 2. The validating authority shall specify, when applicable, any: (a) exemption to the applicable requirements; (b) deviation from the applicable requirements; or (c) compensating factors that provide an equivalent level of safety when applicable requirements are not complied with. 3. In addition to the requirements set out in paragraphs 1 and 2, the validating authority shall specify any special condition to be applied if the related airworthiness codes, laws, regulations and administrative provisions do not contain adequate or appropriate safety requirements for the civil aeronautical product, because: (a) the civil aeronautical product has novel or unusual design features relative to the design practices on which the applicable airworthiness codes, laws, regulations and administrative provisions are based; (b) the intended use of the civil aeronautical product is unconventional; or (c) experience obtained from other, similar civil aeronautical products in service or civil aeronautical products having similar design features has shown that unsafe conditions may develop. 4. When specifying exemptions, deviations, compensating factors or special conditions, the validating authority shall give due consideration to these applied by the certificating authority and they shall not be more demanding for the civil aeronautical products to be validated than they would be for its own similar products. The validating authority shall notify the certificating authority of any such exemptions, deviations, compensating factors or special conditions. Article 12 Level of involvement of the validating authority 1. The level of involvement of the validating authority of a Party during the validation process referred to in Article 9 and as detailed in the technical implementation procedures, shall be mainly determined by: (a) the experience and records of the competent authority of the other Party as certificating authority; (b) the experience already gained by that validating authority during previous validation exercises with the competent authority of the other Party; (c) the nature of the design to be validated; (d) the performance and experience of the applicant with the validating authority; and (e) the outcome of qualification requirements assessments referred to in Articles 28 and Article 29. 2. The validating authority shall exercise special procedures and scrutiny, in particular regarding the certificating authority's processes and methods, during the first validation of any certificate, where the certificating authority has not previously issued a certificate in the category of civil aeronautical products concerned after 30 September 2004. The procedures and criteria to be applied shall be detailed in the technical implementation procedures. 3. The effective implementation of the principles set out in paragraphs 1 and 2 shall be regularly measured, monitored, reviewed by the Certification Oversight Board, using metrics as detailed in the technical implementation procedures. Article 13 Acceptance 1. For a design certificate subject to acceptance, the validating authority shall accept the design certificate issued by the certificating authority without any validation activities. In that case, the design certificate shall be recognised by the validating authority as equivalent to a certificate issued in accordance with laws, regulations and administrative provisions of its Party and the validating authority shall not issue its corresponding certificate. 2. Non-significant supplemental type certificates, non-significant major changes and technical standard order authorisations issued by the technical agent of the Union as certificating authority or by an approved organisation under Union law shall be accepted by the technical agent of the United Kingdom as validating authority. 3. Minor changes and repairs approved by the technical agent of the Union as certificating authority or by an approved organisation under Union law shall be accepted by the technical agent of the United Kingdom as validating authority. 4. Minor changes and minor repairs approved by the technical agent of the United Kingdom as certificating authority or by an approved organisation under laws and regulations of the United Kingdom shall be accepted by the technical agent of the Union as validating authority. Article 14 Implementation provisions for Articles 10 and 13 1. The minor change or major change classifications shall be made by the certificating authority in accordance with the definitions set out in this Annex and interpreted in accordance with the applicable rules and procedures of the certificating authority. 2. For classifying a supplemental type certificate or major change as significant or non-significant, the certificating authority shall consider the change in the context of all previous relevant design changes and all related revisions to the applicable certification specifications incorporated in the type certificate for the civil aeronautical product. Changes that meet either of the following criteria are automatically considered as significant: (a) the general configuration or the principles of construction are not retained; or (b) the assumptions used for certification of the product to be changed do not remain valid. Article 15 Existing design certificates For the purposes of this Annex, the following apply: (a) type certificates, supplemental type certificates, approvals for changes and repairs, as well as technical standard order authorisations and changes thereto issued by the technical agent of the Union to United Kingdom applicants, or by an approved design organisation located in the United Kingdom, on the basis of Union law and valid on 31 December 2020 are deemed to have been issued by the technical agent of the United Kingdom as certificating authority or by an approved organisation under the laws and regulations of the United Kingdom and to have been accepted by the technical agent of the Union as validating authority in accordance with Article 13(1); (b) type certificates, supplemental type certificates, approvals for changes and repairs, as well as technical standard order authorisations and changes thereto issued by the technical agent of the Union to Union applicants, or by a design organisation located in the Union, on the basis of Union law and valid on 31 December 2020 are deemed to have been accepted by the technical agent of the United Kingdom as validating authority in accordance with Article 13(1). Article 16 Transfer of a design certificate In the event that a design certificate is transferred to another entity, the certificating authority responsible for the design certificate shall promptly notify the validating authority of the transfer and apply the procedure related to the transfer of design certificates as detailed in the technical implementation procedures. Article 17 Design-related operational requirements 1. The technical agents shall ensure that, where necessary, data and information related to design-related operational requirements shall be exchanged during the validation process. 2. Subject to decision by the technical agents for some design-related operational requirements, the validating authority may accept the compliance statement of the certificating authority through the validation process. Article 18 Operational documents and data related to the type 1. Some type-specific sets of operational documents and data, including operational suitability data in the Union system and the equivalent data in the United Kingdom system, provided by the type certificate holder shall be approved or accepted by the certificating authority and, where necessary, exchanged during the validation process. 2. Operational documents and data referred to in paragraph 1 may be either accepted or validated by the validating authority as detailed in the technical implementation procedures. Article 19 Concurrent validation When decided by the applicant and the technical agents, a concurrent certification and validation process may be used, where appropriate and as detailed in the technical implementation procedures. Article 20 Continuing airworthiness 1. The competent authorities shall take action to address unsafe conditions in civil aeronautical products for which they are the certificating authority. 2. Upon request, a competent authority of a Party shall, in respect of civil aeronautical products designed or manufactured under its regulatory system, assist the competent authority of the other Party in determining any action considered to be necessary for the continued airworthiness of the civil aeronautical products. 3. When in-service difficulties or other potential safety issues affecting a civil aeronautical product within the scope of this Annex lead to an investigation conducted by the technical agent of a Party that is the certificating authority for the civil aeronautical product, the technical agent of the other Party shall, upon request, support that investigation, including by providing relevant information reported by relevant entities on failures, malfunctions, defects or other occurrences affecting that civil aeronautical product. 4. The reporting obligations of the design certificate holders to the certificating authority and the information exchange mechanism established under this Annex shall be considered to fulfil the obligation of each design certificate holder to report failures, malfunctions, defects or other occurrences affecting that civil aeronautical product to the validating authority. 5. Actions to address unsafe conditions and exchange of safety information referred to in paragraphs 1 to 4 shall be detailed in the technical implementation procedures. 6. The technical agent of a Party shall keep the technical agent of the other Party informed of all its mandatory continuing airworthiness information in relation to civil aeronautical products designed or manufactured under its oversight system, and which are within the scope of this Annex. 7. Any changes to the airworthiness status of a certificate issued by a Party's technical agent shall be communicated in a timely manner to the other Party's technical agent. SECTION E PRODUCTION CERTIFICATION Article 21 Recognition of production certification and production oversight systems 1. The importing Party shall recognise the production certification and production oversight system of the exporting Party, since the system is considered sufficiently equivalent to the system of the importing Party within the scope of this Annex, subject to the provisions of this Article. 2. The recognition of the production certification and production oversight system of the United Kingdom by the Union is limited to the recognition of the production of categories of civil aeronautical products that were already subject to that system on 31 December 2020, as detailed in the technical implementation procedures. 3. In the event that a new category of civil aeronautical products is added to the exporting Party's production certification and production oversight system, the competent authority of the exporting Party shall notify the technical agent of the importing Party. Before extending the recognition of the production certification and production oversight system to the new category of civil aeronautical products, the technical agent of the importing Party may decide to conduct an assessment to confirm that the production certification and production oversight system of the exporting Party for this category of civil aeronautical products is sufficiently equivalent to the production certification and production oversight system of the importing Party. That assessment shall be performed as detailed in the technical implementation procedures, and may include an assessment of the production approval holder under the oversight of the competent authority of the exporting Party. The process for the extension of the recognition of the production certification and production oversight system of the exporting Party to the new category of civil aeronautical products by the importing Party shall be detailed in the technical implementation procedures. 4. The recognition of the production certification and production oversight system of the exporting Party by the importing Party shall be subject to the level of safety provided by the production certification and production oversight system of the exporting Party remaining sufficiently equivalent to that provided by the system of the importing Party. The equivalence of the production certification and production oversight system shall be continuously monitored through the procedures set out in Article 29. 5. Paragraphs 1 to 3 also apply to the production of a civil aeronautical product for which the State of Design responsibilities are exercised by a country other than the exporting Party of the civil aeronautical product, provided that the competent authority of the exporting Party has established and implemented the necessary procedures with the relevant authority of the State of Design to control the interface between the design certificate holder and the production approval holder for that civil aeronautical product. Article 22 Extension of production approval 1. A production approval issued by the competent authority of the exporting Party to a manufacturer primarily located in the territory of that exporting Party and recognised under Article 21(1) may be extended to include manufacturing sites and facilities of the manufacturer located in the territory of the other Party or in the territory of a third country, irrespective of the legal status of those manufacturing sites and facilities, and irrespective of the type of civil aeronautical product manufactured in those sites and facilities. In that case, the competent authority of the exporting Party shall remain responsible for the oversight of those manufacturing sites and facilities and the competent authority of the importing Party shall not issue its own production approval to these manufacturing sites and facilities for the same civil aeronautical product. 2. If facilities and manufacturing sites for a manufacturer primarily located in the territory of the exporting Party are located in the other Party, the competent authorities of both Parties shall cooperate with each other, in the framework of Article 32, with a view to having the importing Party participating in the oversight activities of the exporting Party in relation to these facilities. Article 23 Interface between the production approval holder and the design certificate holder 1. In cases where the production approval holder for a civil aeronautical product is regulated by the competent authority of a Party, and the design certificate holder for the same civil aeronautical product is regulated by the competent authority of the other Party, the competent authorities of the Parties shall establish procedures to define the responsibilities of each Party to control the interface between the production approval holder and the design certificate holder. 2. For the purpose of export of civil aeronautical products within the framework of this Annex, when the design certificate holder and the production approval holder are not the same legal entity, the competent authorities of the Parties shall ensure that the design certificate holder establishes proper arrangements with the production approval holder to ensure satisfactory coordination between design and production and the proper support of the continued airworthiness of the civil aeronautical product. SECTION F EXPORT CERTIFICATES Article 24 Forms The exporting Party's forms are: (a) when the exporting Party is the United Kingdom, CAA Form 52 for new aircraft, export certificate of airworthiness for used aircraft, and CAA Form 1 for other new products; and (b) when the exporting Party is the Union, EASA Form 52 for new aircraft, export certificate of airworthiness for used aircraft, and EASA Form 1 for other new products. Article 25 Issuance of an export certificate 1. When issuing an export certificate, the competent authority or production approval holder of the exporting Party shall ensure that such civil aeronautical product: (a) conforms to the design automatically accepted or validated, or certified by the importing Party in accordance with this Annex and as detailed in the technical implementation procedures; (b) is in a condition for safe operation; (c) meets all additional requirements notified by the importing Party; and (d) as regards civil aircraft, aircraft engines and aircraft propellers, complies with the applicable mandatory continuing airworthiness information, including airworthiness directives of the importing Party, as notified by that Party. 2. When issuing an export certificate of airworthiness for a used aircraft registered in the exporting Party, in addition to the requirements referred to in points (a) to (d) of paragraph 1, the competent authority of the exporting Party shall ensure that such aircraft has been properly maintained using approved procedures and methods of the exporting Party during its service life, as evidenced by logbooks and maintenance records. Article 26 Acceptance of an export certificate for a new civil aeronautical product The competent authority of the importing Party shall accept an export certificate issued by the competent authority or a production approval holder of the exporting Party for a civil aeronautical product, in accordance with the terms and conditions set out in this Annex and as detailed in the technical implementation procedures. Article 27 Acceptance of an export certificate of airworthiness for a used aircraft 1. The competent authority of the importing Party shall accept an export certificate of airworthiness issued by the competent authority of the exporting Party for a used aircraft in accordance with the terms and conditions set out in this Annex and the technical implementation procedures only if a holder of either a type certificate or a restricted type certificate exists for the used aircraft to support continued airworthiness of that type of aircraft. 2. For an export certificate of airworthiness for a used aircraft manufactured under the production oversight of the exporting Party to be accepted in accordance with paragraph 1, the competent authority of the exporting Party shall assist, upon request, the competent authority of the importing Party in obtaining data and information regarding: (a) the configuration of the aircraft at the time of dispatch from the manufacturer; and (b) subsequent changes and repairs applied to the aircraft that it has approved. 3. The importing Party may request inspection and maintenance records as detailed in the technical implementation procedures. 4. If, in the process of assessing the airworthiness status of a used aircraft considered for export, the competent authority of the exporting Party is unable to satisfy all of the requirements set out in Article 25(2) and in paragraphs 1 and 2 of this Article, it shall: (a) notify the competent authority of the importing Party; (b) coordinate with the competent authority of the importing Party, as detailed in the technical implementation procedures, their acceptance or rejection of the exceptions to the applicable requirements; and (c) keep a record of any accepted exceptions when exporting. SECTION G QUALIFICATION OF COMPETENT AUTHORITIES Article 28 Qualification requirements for the acceptance of findings of compliance and certificates 1. Each Party shall maintain a structured and effective certification and oversight system for the implementation of this Annex, including: (a) a legal and regulatory framework, ensuring in particular regulatory powers over entities regulated under the regulatory system for civil aviation safety of the Party; (b) an organisational structure, including a clear description of responsibilities; (c) sufficient resources, including qualified staff with sufficient knowledge, experience and training; (d) adequate processes documented in policies and procedures; (e) documentation and records; and (f) an established inspection programme ensuring uniform level of implementation of the legal and regulatory framework among the various components of the oversight system. Article 29 Continued qualifications of the competent authorities 1. In order to maintain mutual confidence in each Party's regulatory system concerning the implementation of this Annex so that they ensure a sufficiently equivalent level of safety, the technical agent of each Party shall regularly assess the other Party's competent authorities' compliance with the qualification requirements referred to in Article 28. The modalities of such continued mutual assessments shall be detailed in the technical implementation procedures. 2. The competent authority of a Party shall cooperate with the competent authority of the other Party whenever such assessments are required and ensure that regulated entities subject to its oversight provide access to the technical agents of the Parties. 3. If the technical agent of either Party believes that the technical competence of a competent authority of the other Party is no longer adequate, or that the acceptance of findings of compliance made or certificates issued by that competent authority should be suspended as the other Party's systems concerning the implementation of this Annex no longer ensure a sufficiently equivalent level of safety to permit such acceptance, the technical agents of the Parties shall consult in order to identify remedial actions. 4. If mutual confidence is not restored through mutually acceptable means, the technical agent of each Party may refer the matter referred to in paragraph 3 to the Certification Oversight Board. 5. If the matter is not resolved by the Certification Oversight Board, each Party may refer the matter referred to in paragraph 3 to the Specialised Committee on Aviation Safety. SECTION H COMMUNICATIONS, CONSULTATIONS AND SUPPORT Article 30 Communications Subject to the exceptions decided by the technical agents of the Parties on a case-by-case basis, all communications between the competent authorities of the Parties, including documentation as detailed in the technical implementation procedures, shall be made in the English language. Article 31 Technical consultations 1. The technical agents of the Parties shall address issues concerning the implementation of this Annex through consultations. 2. If a mutually acceptable solution is not reached through consultations held pursuant to paragraph 1, the technical agent of each Party may refer an issue as referred to in paragraph 1 to the Certification Oversight Board. 3. If the issue is not resolved by the Certification Oversight Board, each Party may refer an issue as referred to in paragraph 1 to the Specialised Committee on Aviation Safety. Article 32 Support for certification and continued airworthiness oversight activities Upon request, after mutual consent, and as resources permit, the competent authority of a Party may provide technical support, data and information to the competent authority of the other Party in certification and continued airworthiness oversight activities related to design, production and environmental protection certification. The support to be provided and the process for providing such support shall be detailed in the technical implementation procedures. ANNEX 31 TRANSPORT OF GOODS BY ROAD PART A REQUIREMENTS FOR ROAD HAULAGE OPERATORS IN ACCORDANCE WITH ARTICLE 463 OF THIS AGREEMENT SECTION 1 ADMISSION TO, AND THE PURSUIT OF, THE OCCUPATION OF ROAD HAULAGE OPERATOR Article 1 Scope This Section governs admission to, and the pursuit of, the occupation of road haulage operator and shall apply to all road haulage operators of a Party engaged in the transport of goods within the scope of Article 462 of this Agreement. Article 2 Definitions For the purposes of this Section, the following definitions apply: (a) \"authorisation to pursue the occupation of road haulage operator\" means an administrative decision which authorises a natural or legal person who fulfils the conditions laid down in this Section to pursue the occupation of road haulage operator; (b) \"competent authority\" means a national, regional or local authority in a Party which, for the purpose of authorising the pursuit of the occupation of road haulage operator, verifies whether a natural or legal person fulfils the conditions laid down in this Section, and which is empowered to grant, suspend or withdraw an authorisation to pursue the occupation of road haulage operator; and (c) \"normal residence\" means the place where a person usually lives, that is for at least 185 days in each calendar year, because of personal ties which show close links between that person and the place where that person is living. Article 3 Requirements for engagement in the occupation of road haulage operator Natural or legal persons engaged in the occupation of road haulage operator shall: (a) have an effective and stable establishment in a Party as laid down in Article 5 of this Section; (b) be of good repute as laid down in Article 6 of this Section; (c) have appropriate financial standing as laid down in Article 7 of this Section; and (d) have the requisite professional competence as laid down in Article 8 of this Section. Article 4 Transport manager 1. A road haulage operator shall designate at least one natural person to be the transport manager, who effectively and continuously manages its transport activities and fulfils the requirements set out in points (b) and (d) of Article 3 and who: (a) has a genuine link to the road haulage operator, such as being an employee, director, owner or shareholder or administering it, or is that person; and (b) is resident in the Party in the territory of which the road haulage operator is established. 2. If a natural or legal person does not fulfil the requirement of professional competence, the competent authority may authorise the natural or legal person to engage in the occupation of road haulage operator without designating a transport manager in accordance with paragraph 1, provided that: (a) the natural or legal person designates a natural person residing in the Party of establishment of the road haulage operator who fulfils the requirements laid down in points (b) and (d) of Article 3 and who is entitled under contract to carry out duties as transport manager on behalf of the undertaking; (b) the contract linking the natural or legal person with the person referred to in point (a) specifies the tasks to be performed on an effective and continuous basis by that person and indicates that person's responsibilities as transport manager. The tasks to be specified shall comprise, in particular, those relating to vehicle maintenance management, verification of transport contracts and documents, basic accounting, the assignment of loads or services to drivers and vehicles, and the verification of safety procedures; (c) in his or her capacity as transport manager, the person referred to in point (a) may manage the transport activities of up to four different road haulage operators carried out with a combined maximum total fleet of 50 vehicles; and (d) the person referred to in point (a) performs the specified tasks solely in the interests of the natural or legal person and that person's responsibilities are exercised independently of any natural or legal persons for which it carries out transport operations. 3. A Party may decide that a transport manager designated in accordance with paragraph 1 may not in addition be designated in accordance with paragraph 2, or may only be so designated in respect of a limited number of natural or legal persons or a fleet of vehicles that is smaller than that referred to in point (c) of paragraph 2. 4. The natural or legal person shall notify the competent authority of the transport manager or managers designated. Article 5 Conditions relating to the requirement of establishment In order to fulfil the requirement of effective and stable establishment in the Party of establishment, a natural or legal person shall: (a) have premises at which it is able to access the originals of its core business documents, whether in electronic or any other form in particular its transport contracts, documents relating to the vehicles at the disposal of the natural or legal person, accounting documents, personnel management documents, labour contracts, social security documents, documents containing data on the dispatching and posting of drivers, documents containing data relating to journeys, driving time and rest periods, and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this Section; (b) be registered in the register of commercial companies of that Party or in a similar register whenever required under national law; (c) be subject to tax on revenues and, whenever required under national law, have assigned a VAT identification number; (d) once an authorisation has been granted, have at its disposal one or more vehicles which are registered or put into circulation and authorised to be used in conformity with the legislation of that Party, regardless of whether those vehicles are wholly owned or, for example, are held under a hire-purchase agreement or under a hire or leasing contract; (e) effectively and continuously conduct its administrative and commercial activities with the appropriate equipment and facilities at premises as referred to in point (a) situated in that Party and manage effectively and continuously its transport operations using the vehicles referred to in point (f) with the appropriate technical equipment situated in that Party; and (f) on an ongoing basis, have at its regular disposal a number of vehicles complying with the conditions laid down in point (d) and drivers normally based at an operational centre in that Party, proportionate to the volume of transport operations carried out by the undertaking. Article 6 Conditions relating to the requirement of good repute 1. Subject to paragraph 2, the Parties shall determine the conditions to be met by natural or legal persons and transport managers in order to fulfil the requirement of good repute. In determining whether a natural or legal person has fulfilled that requirement, the Parties shall consider the conduct of the natural or legal person, its transport managers, executive directors and any other relevant person as may be determined by the Party. Any reference in this Article to convictions, penalties or infringements shall include convictions, penalties or infringements of the natural or legal person itself, its transport managers, executive directors and any other relevant person as may be determined by the Party. The conditions referred to in this paragraph shall include at least the following: (a) that there be no compelling grounds for doubting the good repute of the transport manager or the road haulage operator, such as convictions or penalties for any serious infringement of national rules in force in the fields of: (i) commercial law; (ii) insolvency law; (iii) pay and employment conditions in the profession; (iv) road traffic; (v) professional liability; (vi) trafficking in human beings or drugs; (vii) tax law; and (b) that the transport manager or the road haulage operator have not in one or both Parties been convicted of a serious criminal offence or incurred a penalty for a serious infringement of the rules of Title I of Heading Three of Part Two of this Agreement or of national rules relating in particular to: (i) the driving time and rest periods of drivers, working time and the installation and use of recording equipment; (ii) the maximum weights and dimensions of commercial vehicles used in international traffic; (iii) the initial qualification and continuous training of drivers; (iv) the roadworthiness of commercial vehicles, including the compulsory technical inspection of motor vehicles; (v) access to the market in international road haulage; (vi) safety in the carriage of dangerous goods by road; (vii) the installation and use of speed-limiting devices in certain categories of vehicle; (viii) driving licences; (ix) admission to the occupation; (x) animal transport; (xi) the posting of workers in road transport; (xii) the law applicable to contractual obligations; and (xiii) journeys whose points of loading and unloading are situated in the other Party. 2. For the purposes of point (b) of the third subparagraph of paragraph 1 of this Article, where the transport manager or the road haulage operator has been convicted of a serious criminal offence or has incurred a penalty for one of the most serious infringements as set out in Appendix 31-A-1-1 in one or both Parties, the competent authority in the Party of establishment shall carry out and complete in an appropriate and timely manner an administrative procedure, which shall include, if appropriate, an on-site inspection at the premises of the natural or legal person concerned. During the administrative procedure, the competent authority shall assess whether, due to specific circumstances, the loss of good repute would constitute a disproportionate response in the individual case. In that assessment, the competent authority shall take into account the number of serious infringements of the rules as referred to in the third subparagraph of paragraph 1 of this Article, as well as the number of most serious infringements as set out in Appendix 31-A-1-1 for which the transport manager or the road haulage operator have been convicted or had penalties imposed on them. Any such finding shall be duly reasoned and justified. Where the competent authority finds that the loss of good repute would be disproportionate, it shall decide that the natural or legal person concerned continues to be of good repute. Where the competent authority does not find that the loss of good repute would be disproportionate, the conviction or penalty shall lead to the loss of good repute. 3. The Specialised Committee on Road Transport shall draw up a list of categories, types and degrees of seriousness of serious infringements which, in addition to those set out in Appendix 31-A-1-1, may lead to the loss of good repute. 4. The requirement of good repute shall not be fulfilled until a rehabilitation measure or any other measure having an equivalent effect has been taken pursuant to the relevant provisions of national law of the Parties. Article 7 Conditions relating to the requirement of financial standing 1. In order to fulfil the requirement of financial standing, a natural or legal person shall, on a permanent basis, be able to meet its financial obligations in the course of the annual accounting year. The natural or legal person shall demonstrate, on the basis of annual accounts certified by an auditor or a duly accredited person, that, every year, it has at its disposal capital and reserves: (a) totalling at least EUR 9 000 / GBP 8 000 when only one motor vehicle is used, EUR 5 000 / GBP 4 500 for each additional motor vehicle or combination of vehicles used that has a permissible laden mass exceeding 3.5 tonnes and EUR 900 / GBP 800 for each additional motor vehicle or combination of vehicles that has a permissible laden mass, exceeding 2.5 tonnes but not 3.5 tonnes; (b) natural or legal persons engaged in the occupation of road haulage operator solely by means of motor vehicles or combinations of vehicles that have a permissible laden mass exceeding 2.5 tonnes but not 3.5 tonnes shall demonstrate, on the basis of annual accounts certified by an auditor or a duly accredited person, that, every year, they have at their disposal capital and reserves totalling at least EUR 1 800 / GBP 1 600 when only one vehicle is used and EUR 900 / GBP 800 for each additional vehicle used. 2. By way of derogation from paragraph 1, the competent authority may agree or require that an undertaking demonstrate its financial standing by means of a certificate determined by the competent authority, such as a bank guarantee or an insurance, including a professional liability insurance from one or more banks or other financial institutions including insurance companies or another binding document providing a joint and several guarantee for the undertaking in respect of the amounts specified in point (a) of paragraph 1. 3. By way of derogation from paragraph 1, in the absence of certified annual accounts for the year of an undertaking's registration, the competent authority shall agree that an undertaking is to demonstrate its financial standing by means of a certificate, such as a bank guarantee, a document issued by a financial institution establishing access to credit in the name of the undertaking, or another binding document as determined by the competent authority proving that the undertaking has at its disposal the amounts specified in point (a) of paragraph 1. 4. The annual accounts referred to in paragraph 1, and the guarantee referred to in paragraph 2, which are to be verified, are those of the economic entity established in the Party in which an authorisation has been applied for and not those of any other entity established in the other Party. Article 8 Conditions relating to the requirement of professional competence 1. In order to satisfy the requirement of professional competence, the person or persons concerned shall possess knowledge corresponding to the level provided for in Part I of Appendix 31-A-1-2 in the subjects listed therein. That knowledge shall be demonstrated by means of a compulsory written examination which, if a Party so decides, may be supplemented by an oral examination. Those examinations shall be organised in accordance with Part II of Appendix 31-A-1-2. To this end, a Party may decide to impose training prior to the examination. 2. The persons concerned shall sit the examination in the Party in which they have their normal residence. 3. Only the authorities or bodies duly authorised for this purpose by a Party, in accordance with criteria defined by it, may organise and certify the written and oral examinations referred to in paragraph 1 of this Article. The Parties shall regularly verify that the conditions under which those authorities or bodies organise the examinations are in accordance with Appendix 31-A-1-2. 4. A Party may exempt the holders of certain higher education qualifications or technical education qualifications issued in that Party, specifically designated to this end and entailing knowledge of all the subjects listed in Appendix 31-A-1-2 from the examination in the subjects covered by those qualifications. The exemption shall only apply to those Sections of Part I of Appendix 31-A-1-2 for which the qualification covers all subjects listed under the heading of each Section. A Party may exempt from specified parts of the examinations holders of certificates of professional competence valid for national transport operations in that Party. Article 9 Exemption from examination For the purpose of granting a licence to a road haulage operator which only operates motor vehicles or combinations of vehicles the permissible laden mass of which does not exceed 3.5 tonnes, a Party may decide to exempt from the examinations referred to in Article 8(1) persons who provide proof that they have continuously managed, for the period of ten years before 20 August 2020, a natural or legal person of the same type. Article 10 Procedure for the suspension and withdrawal of authorisations 1. Where a competent authority establishes that a natural or legal person runs the risk of no longer fulfilling the requirements laid down in Article 3, it shall notify the natural or legal person thereof. Where a competent authority establishes that one or more of those requirements is no longer satisfied, it may set one of the following time limits for the natural or legal person to rectify the situation: (a) a time limit not exceeding 6 months, which may be extended by 3 months in the event of the death or physical incapacity of the transport manager, for the recruitment of a replacement transport manager where the transport manager no longer satisfies the requirement as to good repute or professional competence; (b) a time limit not exceeding 6 months where the natural or legal person has to rectify the situation by demonstrating that the natural or legal person has an effective and stable establishment; or (c) a time limit not exceeding 6 months where the requirement of financial standing is not satisfied, in order to demonstrate that that requirement is again satisfied on a permanent basis. 2. The competent authority may require a natural or legal person whose authorisation has been suspended or withdrawn to ensure that its transport managers have passed the examinations referred to in Article 8(1) prior to any rehabilitation measure being taken. 3. If the competent authority establishes that the natural or legal person no longer satisfies one or more of the requirements laid down in Article 3, it shall suspend or withdraw the authorisation to engage in the occupation of road haulage operator within the time limits referred to in paragraph 1 of this Article. Article 11 Declaration of unfitness of the transport manager 1. Where a transport manager loses good repute in accordance with Article 6, the competent authority shall declare that transport manager unfit to manage the transport activities of a road haulage operator. The competent authority shall not rehabilitate the transport manager earlier than one year from the date of the loss of good repute and before the transport manager has demonstrated to have followed appropriate training for a period of at least 3 months or an exam on the subjects listed in Part I of Appendix 31-A-1-2. 2. Where a transport manager loses good repute in accordance with Article 6, an application for rehabilitation may be introduced after no less than one year from the date of the loss of good repute. Article 12 Examination and registration of applications 1. The competent authorities in each Party shall record in the national electronic registers referred to in Article 13(1) the data relating to undertakings which they authorise. 2. When assessing the good repute of an undertaking, the competent authorities shall verify, whether at the time of the application the designated transport manager or managers are declared, in one of the Parties, unfit to manage the transport activities of an undertaking pursuant to Article 11. 3. The competent authorities shall regularly monitor whether undertakings which they have authorised to engage in the occupation of road haulage operators continue to fulfil the requirements referred to in Article 3. To that end, the competent authorities shall carry out checks, including, where appropriate, on-site inspections at the premises of the undertaking concerned, targeting those undertakings which are classed as posing an increased risk. Article 13 National electronic registers 1. The competent authorities shall keep a national electronic register of road transport undertakings which have been authorised to engage in the occupation of road haulage operator. 2. The Specialised Committee on Road Transport shall establish the data contained in the national registers of road transport undertakings and the conditions of access to this data. Article 14 Administrative cooperation between the competent authorities 1. The competent authorities in each Party shall designate a national contact point responsible for the exchange of information with the competent authorities of the other Party with regard to the application of this Section. 2. The competent authorities in each Party shall cooperate closely and shall swiftly provide one another with mutual assistance and with any other relevant information in order to facilitate the implementation and enforcement of this Section. 3. The competent authorities in each Party shall carry out individual checks to verify whether an undertaking meets the conditions governing admission to the occupation of road haulage operator whenever a competent authority in the other Party so requests in duly justified cases. It shall inform the competent authority in the other Party of the results of such checks and of the measures taken if it is established that the undertaking no longer fulfils the requirements laid down in this Section. 4. The competent authorities in each Party shall exchange information on convictions and penalties for any serious infringements referred to in Article 6(2). 5. The Specialised Committee on Road Transport shall establish detailed rules on the modalities of the exchange of information referred to in paragraphs 3 and 4. Appendix 31-A-1-1 MOST SERIOUS INFRINGEMENTS FOR THE PURPOSE OF ARTICLE 6(2) OF SECTION 1 OF PART A OF ANNEX 31 1. Exceeding time limits as follows: (a) exceeding the maximum 6-day or fortnightly driving time limits by margins of 25 % or more; (b) exceeding, during a daily working period, the maximum daily driving time limit by a margin of 50 % or more. 2. Not having a tachograph and/or speed limiter, or having in the vehicle and/or using a fraudulent device able to modify the records of the recording equipment and/or the speed limiter or falsifying record sheets or data downloaded from the tachograph and/or the driver card. 3. Driving without a valid roadworthiness certificate and/or driving with a very serious deficiency of, inter alia, the braking system, the steering linkages, the wheels/tyres, the suspension or chassis that would create such an immediate risk to road safety that it leads to a decision to immobilise the vehicle. 4. Transporting dangerous goods that are prohibited for transport or transporting such goods in a prohibited or non-approved means of containment or without identifying them on the vehicle as dangerous goods, thus endangering lives or the environment to such extent that it leads to a decision to immobilise the vehicle. 5. Carrying goods without holding a valid driving licence or carrying by an undertaking not holding a valid operator's licence as referred to in Article 463 of this Agreement. 6. Driving with a driver card that has been falsified, or with a card of which the driver is not the holder, or which has been obtained on the basis of false declarations and/or forged documents. 7. Carrying goods exceeding the maximum permissible laden mass by 20 % or more for vehicles the permissible laden weight of which exceeds 12 tonnes, and by 25 % or more for vehicles the permissible laden weight of which does not exceed 12 tonnes. Appendix 31-A-1-2 PART I LIST OF SUBJECTS REFERRED TO IN ARTICLE 8 OF SECTION 1 OF PART A OF ANNEX 31 The knowledge to be taken into consideration for the official recognition of professional competence by the Parties must cover at least the subjects listed below. In relation to those subjects, applicant road haulage operators must have the levels of knowledge and practical aptitude necessary for the management of a transport undertaking. The minimum level of knowledge, as indicated below, must correspond at least to the level of knowledge acquired during the course of compulsory education, which is supplemented either by vocational training and supplementary technical training or by secondary school or other technical training. A. Civil law The applicant must, in particular: (a) be familiar with the main types of contract used in road transport and with the rights and obligations arising therefrom; (b) be capable of negotiating a legally valid transport contract, notably with regard to conditions of carriage; (c) be able to consider a claim by the applicant's principal regarding compensation for loss of or damage to goods during transportation or for their late delivery, and to understand how such a claim affects the applicant's contractual liability; and (d) be familiar with the rules and obligations arising from the CMR Convention on the Contract for the International Carriage of Goods by Road, done in Geneva on 19 May 1956. B. Commercial law The applicant must, in particular: (a) be familiar with the conditions and formalities laid down for plying the trade, the general obligations incumbent upon transport operators (registration, record keeping, etc.) and the consequences of bankruptcy; and (b) have appropriate knowledge of the various forms of commercial companies and the rules governing their constitution and operation. C. Social law The applicant must, in particular, be familiar with the following: (a) the role and function of the various social institutions which are concerned with road transport (trade unions, works councils, shop stewards, labour inspectors, etc.); (b) the employers' social security obligations; (c) the rules governing work contracts for the various categories of worker employed by road transport undertakings (form of the contracts, obligations of the parties, working conditions and working hours, paid leave, remuneration, breach of contract, etc.); (d) the rules applicable to driving time, rest periods and working time, and the practical measures for applying those provisions; and (e) the rules applicable to the initial qualification and continuous training of drivers laid down in Section 1 of Part B of this Annex. D. Fiscal law The applicant must, in particular, be familiar with the rules governing: (a) value added tax (VAT) on transport services; (b) motor-vehicle tax; (c) the taxes on certain road haulage vehicles and tolls and infrastructure user charges; and (d) income tax. E. Business and financial management The applicant must, in particular: (a) be familiar with the laws and practices regarding the use of cheques, bills of exchange, promissory notes, credit cards and other means or methods of payment; (b) be familiar with the various forms of credit (bank credit, documentary credit, guarantee deposits, mortgages, leasing, renting, factoring, etc.) and the charges and obligations arising therefrom; (c) know what a balance sheet is, how it is set out and how to interpret it; (d) be able to read and interpret a profit and loss account; (e) be able to assess the undertaking's profitability and financial position, in particular on the basis of financial ratios; (f) be able to prepare a budget; (g) be familiar with the cost elements of the undertaking (fixed costs, variable costs, working capital, depreciation, etc.), and be able to calculate costs per vehicle, per kilometre, per journey or per tonne; (h) be able to draw up an organisation chart relating to the undertaking's personnel as a whole and to organise work plans, etc.; (i) be familiar with the principles of marketing, publicity and public relations, including transport services, sales promotion and the preparation of customer files, etc.; (j) be familiar with the different types of insurance relating to road transport (liability, accidental injury/life insurance, non-life and luggage insurance) and the guarantees and obligations arising therefrom; (k) be familiar with the applications of electronic data transmission in road transport; (l) be able to apply the rules governing the invoicing of road haulage services and know the meaning and implications of Incoterms; and (m) be familiar with the different categories of transport auxiliaries, their role, their functions and, where appropriate, their status. F. Access to the market The applicant must, in particular, be familiar with the following: (a) the occupational regulations governing road transport, industrial vehicle rental and subcontracting, and in particular the rules governing the official organisation of the occupation, admission to the occupation, authorisations for road transport operations, inspections and penalties; (b) the rules for setting up a road transport undertaking; (c) the various documents required for operating road transport services and the introduction of checking procedures to ensure that the approved documents relating to each transport operation, and in particular those relating to the vehicle, the driver, the goods and luggage are kept both in the vehicle and on the premises of the undertaking; (d) the rules on the organisation of the market in road haulage services, as well as the rules on freight handling and logistics; and (e) border formalities, the role and scope of T documents and TIR carnets, and the obligations and responsibilities arising from their use. G. Technical standards and technical aspects of operation The applicant must, in particular: (a) be familiar with the rules concerning the weights and dimensions of vehicles in the Parties and the procedures to be followed in the case of abnormal loads which constitute an exception to these rules; (b) be able to choose vehicles and their components (chassis, engine, transmission system, braking system, etc.) in accordance with the needs of the undertaking; (c) be familiar with the formalities relating to the type approval, registration and technical inspection of these vehicles; (d) understand what measures must be taken to reduce noise and to combat air pollution by motor vehicle exhaust emissions; (e) be able to draw up periodic maintenance plans for the vehicles and their equipment; (f) be familiar with the different types of cargo-handling and loading devices (tailboards, containers, pallets, etc.) and be able to introduce procedures and issue instructions for loading and unloading goods (load distribution, stacking, stowing, blocking and chocking, etc.); (g) be familiar with the various techniques of \"piggy-back\" and roll-on roll-off combined transport; (h) be able to implement procedures to comply with the rules on the carriage of dangerous goods and waste; (i) be able to implement procedures to comply with the rules on the carriage of perishable foodstuffs, notably those arising from the Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to be used for such Carriage (ATP); and (j) be able to implement procedures to comply with the rules on the transport of live animals. H. Road safety The applicant must, in particular: (a) know what qualifications are required for drivers (driving licence, medical certificates, certificates of fitness, etc.); (b) be able to take the necessary steps to ensure that drivers comply with the traffic rules, prohibitions and restrictions in force in the Parties (speed limits, priorities, waiting and parking restrictions, use of lights, road signs, etc.); (c) be able to draw up instructions for drivers to check their compliance with the safety requirements concerning the condition of the vehicles, their equipment and cargo, and concerning preventive measures to be taken; (d) be able to lay down procedures to be followed in the event of an accident and to implement appropriate procedures to prevent the recurrence of accidents or serious traffic offences; and (e) be able to implement procedures to properly secure goods and be familiar with the corresponding techniques. PART II ORGANISATION OF THE EXAMINATION 1. The Parties will organise a compulsory written examination which they may supplement by an optional oral examination to establish whether applicant road haulage operators have achieved the required level of knowledge in the subjects listed in Part I and in particular their capacity to use the instruments and techniques relating to those subjects and to fulfil the corresponding executive and coordination duties. (a) The compulsory written examination will involve two tests, namely: (i) written questions consisting of either multiple choice questions (each with four possible answers), questions requiring direct answers or a combination of both systems; and (ii) written exercises/case studies. The minimum duration of each test will be two hours. (b) Where an oral examination is organised, the Parties may stipulate that participation is subject to the successful completion of the written examination. 2. Where the Parties also organise an oral examination, they must provide, in respect of each of the three tests, for a weighting of marks of a minimum of 25 % and a maximum of 40 % of the total number of marks to be given. Where the Parties organise only a written examination, they must provide, in respect of each test, for a weighting of marks of a minimum of 40 % and a maximum of 60 % of the total number of marks to be given. 3. With regard to all the tests, applicants must obtain an average of at least 60 % of the total number of marks to be given, achieving in any given test not less than 50 % of the total number of marks possible. In one test only, a Party may reduce that mark from 50 % to 40 %. Appendix 31-A-1-3 PART A LICENCE MODEL FOR THE UNION EUROPEAN COMMUNITY (a) (Colour Pantone light blue 290, or as close as possible to this colour, format DIN A4 cellulose paper 100 g/m2 or more) (First page of the licence) (Text in (one of) the official language(s) of the Member State issuing the licence) Distinguishing sign of the Member State( 1 ) issuing the licence Name of the competent authority or body LICENCE No ... or CERTIFIED TRUE COPY No ... for the international carriage of goods by road for hire or reward This licence entitles( 2 ) \u2026 \u2026 \u2026 to engage in the international carriage of goods by road for hire or reward by any route, for journeys or parts of journeys carried out for hire or reward within the territory of the Community, as laid down in Regulation (EC) No 1072/2009 of the European Parliament and of the Council of 21 October 2009 (OJ EU L 300, 14.11.2009, p. 72) on common rules for access to the international road haulage market and in accordance with the general provisions of this licence. Particular remarks: \u2026 \u2026 This licence is valid from \u2026. to .\u2026 Issued in \u2026, on \u2026 \u2026 ( 3 ) ______________ (1) The distinguishing signs of the Member States are: (B) Belgium, (BG) Bulgaria, (CZ) Czech Republic, (DK) Denmark, (D) Germany, (EST) Estonia, (IRL) Ireland, (GR) Greece, (E) Spain, (F) France, (HR) Croatia, (I) Italy, (CY) Cyprus, (LV) Latvia, (LT) Lithuania, (L) Luxembourg, (H) Hungary, (MT) Malta, (NL) Netherlands, (A) Austria, (PL) Poland, (P) Portugal, (RO) Romania, (SLO) Slovenia, (SK) Slovakia, (FIN) Finland, (S) Sweden. (2) Name or business name and full address of the haulier. (3) Signature and seal of the issuing competent authority or body. (b) (Second page of the licence) (Text in (one of) the official language(s) of the Member State issuing the licence) GENERAL PROVISIONS This licence is issued under Regulation (EC) No 1072/2009. It entitles the holder to engage in the international carriage of goods by road for hire or reward by any route for journeys or parts of journeys carried out within the territory of the Community and, where appropriate, subject to the conditions laid down herein: \u2014 where the point of departure and the point of arrival are situated in two different Member States, with or without transit through one or more Member States or third countries, \u2014 from a Member State to a third country or vice versa, with or without transit through one or more Member States or third countries, \u2014 between third countries with transit through the territory of one or more Member States, and unladen journeys in connection with such carriage. In the case of carriage from a Member State to a third country or vice versa, this licence is valid for that part of the journey carried out within the territory of the Community. It shall be valid in the Member State of loading or unloading only after the conclusion of the necessary agreement between the Community and the third country in question in accordance with Regulation (EC) No 1072/2009. The licence is personal to the holder and is non-transferable. It may be withdrawn by the competent authority of the Member State which issued it, notably where the holder has: \u2014 not complied with all the conditions for using the licence, \u2014 supplied incorrect information with regard to the data needed for the issue or extension of the licence. The original of the licence must be kept by the haulage undertaking. A certified copy of the licence must be kept in the vehicle( 1 ). In the case of a coupled combination of vehicles it must accompany the motor vehicle. It covers the coupled combination of vehicles even if the trailer or semi-trailer is not registered or authorised to use the roads in the name of the licence holder or if it is registered or authorised to use the roads in another State. The licence must be presented at the request of any authorised inspecting officer. Within the territory of each Member State, the holder must comply with the laws, regulations and administrative provisions in force in that State, in particular with regard to transport and traffic. __________________ (1) \"Vehicle\" means a motor vehicle registered in a Member State, or a coupled combination of vehicles the motor vehicle of which at least is registered in a Member State, used exclusively for the carriage of goods. PART B LICENCE MODEL FOR THE UNITED KINGDOM UK Licence for the Community (a) (Colour Pantone light blue, format DIN A4 cellulose paper 100 g/m2 or more) (First page of the licence) (Text in English or Welsh) UK NAME OF THE UK COMPETENT AUTHORITY ( 1 ) LICENCE No: Or CERTIFIED TRUE COPY No: for the international carriage of goods by road for hire or reward This licence entitles( 2 ) \u2026 \u2026 \u2026 to engage in the international carriage of goods by road for hire or reward by any route, for journeys or parts of journeys carried out for hire or reward within the territory of a Member State as laid down in Regulation (EC) No 1072/2009( 3 ). Particular remarks: \u2026 \u2026 This licence is valid from \u2026. to \u2026 Issued in \u2026 on \u2026 ___________________________ (1) Competent authority for the relevant region for which the certificate is issued. (2) Name or business name and full address of the haulier. (3) Regulation (EC) No 1072/2009 as retained in UK law by Section 3 of the European Union (Withdrawal) Act 2018 and as amended by regulations made under Section 8 of that Act. (b) (Second page of the licence) (Text in English or Welsh) GENERAL PROVISIONS This licence is issued under Regulation (EC) No 1072/2009( 1 ). It entitles the holder to engage in the international carriage of goods by road for hire or reward by any route for journeys or parts of journeys carried out within the territory of a Member State permitted by any international agreement between the United Kingdom and the European Union or a Member State. In the case of carriage from the United Kingdom to a third country or vice versa, this licence is valid for that part of the journey carried out within the territory of any Member State. The licence is personal to the holder and is non-transferable. It may be withdrawn by a traffic commissioner or the Department for Infrastructure (Northern Ireland), for example, where the holder has: \u2014 not complied with all the conditions for using the licence, \u2014 supplied incorrect information with regard to the data needed for the issue or extension of the licence. The original of the licence must be kept by the haulage undertaking. A certified copy of the licence must be kept in the vehicle( 2 ). In the case of a coupled combination of vehicles it must accompany the motor vehicle. It covers the coupled combination of vehicles even if the trailer or semi-trailer is not registered or authorised to use the roads in the name of the licence holder or if it is registered or authorised to use the roads in another State. The licence must be presented at the request of any authorised inspecting officer. Within the territory of the United Kingdom or each Member State, the holder must comply with the laws, regulations and administrative provisions in force in that State, in particular with regard to transport and traffic. _______________________ (1) Regulation (EC) No 1072/2009 as retained in UK law by Section 3 of the European Union (Withdrawal) Act 2018 and as amended by regulations made under Section 8 of that Act. (2) \"Vehicle\" means a motor vehicle registered in the United Kingdom or a Member State, or a coupled combination of motor vehicles the motor vehicle of which at least is registered in the United Kingdom or a Member State, used exclusively for the carriage of goods. Appendix 31-A-1-4 SECURITY FEATURES OF THE LICENCE The licence must have at least two of the following security features: \u2014 a hologram; \u2014 special fibres in the paper which become visible under UV-light; \u2014 at least one microprint line (printing visible only with a magnifying glass and not reproduced by photocopying machines); \u2014 tactile characters, symbols or patterns; \u2014 double numbering: serial number of the licence, of the certified copy thereof as well as, in each case, the issue number; \u2014 a security design background with fine guilloche patterns and rainbow printing. SECTION 2 POSTING OF DRIVERS Article 1 Subject matter This Section lays down requirements for road haulage operators established in one of the Parties which, in the framework of the transport of goods, post drivers to the territory of the other Party in accordance with Article 3 of this Section. Nothing in this Section shall prevent a Party from applying measures to regulate the entry of natural persons into, or their temporary stay in, its territory, including measures necessary to protect the integrity of its borders and to ensure the orderly movement of natural persons across them, provided that such measures are not applied in such a manner as to nullify or impair the benefits accruing to the other Party under the terms of this Section. The sole fact of requiring a visa for natural persons of certain countries and not for those of others shall not be regarded as nullifying or impairing benefits under this Section. Nothing in this Section shall affect the application on the Union territory of the Union rules on the posting of drivers in road transport to Union road haulage operators. Article 2 Definitions For the purposes of this Section, \"posted driver\" means a driver who, for a limited period, carries out his or her work in the territory of a Party other than the Party in which the driver normally works. Article 3 Principles 1. The provisions of this Section apply to the extent that the road haulage operator posts drivers to the territory of the other Party on its account and under its direction, under a contract concluded between the road haulage operator making the posting and the party for whom the transport services are intended, and those drivers operate in the territory of that Party, provided that there is an employment relationship between the road haulage operator making the posting and the driver during the period of posting. 2. For the purposes of paragraph 1, a posting shall be considered to start when the driver enters the territory of the other Party for the loading and/or unloading of goods and to end when the driver leaves the territory of that Party. For the purposes of paragraph 1, in the case of posting in the Union, a posting shall, be considered to start when the driver enters the territory of a Member State for the loading and/or unloading of goods in that Member State and to end when the driver leaves the territory of that Member State. 3. Notwithstanding the paragraphs 1 and 2, a driver shall not be considered to be posted when performing transport operations, based on a transport contract, as defined in point (a) of Article 462(1) of this Agreement. 4. A driver shall not be considered to be posted in the United Kingdom where the driver transits through the territory of the United Kingdom without loading or unloading of goods. For the Union, a driver shall not be considered to be posted in a Member State when the driver transits through the territory of that Member State without loading or unloading of goods. Article 4 Terms and conditions of employment 1. Each Party shall ensure, irrespective of which law applies to the employment relationship, that road haulage operators guarantee, on the basis of equality of treatment, to drivers who are posted to their territory the terms and conditions of employment covering the following matters which, in the Party or, in the case of the Union, in the Member State where the work is carried out, are laid down: \u2014 by law, regulation or administrative provision, and/or \u2014 by collective agreements or arbitration awards which have been declared universally applicable or otherwise apply in accordance with paragraph 4: (a) maximum work periods and minimum rest periods; (b) minimum paid annual leave; (c) remuneration, including overtime rates; this point does not apply to supplementary occupational retirement pension schemes; (d) health, safety and hygiene at work; (e) protective measures with regard to the terms and conditions of employment of pregnant women or women who have recently given birth, of children and of young people; and (f) equality of treatment between men and women and other provisions on non-discrimination. 2. For the purposes of this Section, the concept of remuneration shall be determined by the national law and/or practice of the Party and, in the case of the Union, by the national law and/or practice of the Member State, to whose territory the driver is posted and means all the constituent elements of remuneration rendered mandatory by national law, regulation or administrative provision, or by collective agreements or arbitration awards which, in that Party or in that Member State, have been declared universally applicable or otherwise apply in accordance with paragraph 4. 3. Allowances specific to the posting shall be considered to be part of remuneration, unless they are paid in reimbursement of expenditure actually incurred on account of the posting, such as expenditure on travel, board and lodging. The road haulage operator shall reimburse the posted driver for such expenditure in accordance with the law and/or practice applicable to the employment relationship. Where the terms and conditions of employment applicable to the employment relationship do not determine which elements of the allowance specific to the posting are paid in reimbursement of expenditure actually incurred on account of the posting or which are part of remuneration, then the entire allowance shall be considered to be paid in reimbursement of expenditure. 4. For the purpose of this Section, \"collective agreements or arbitration awards which have been declared universally applicable\" means collective agreements or arbitration awards which must be observed by all undertakings in the geographical area and in the profession or industry concerned. In the absence of, or in addition to, a system for declaring collective agreements or arbitration awards to be of universal application within the meaning of the first subparagraph, each Party, or each Member State in the case of the Union, may, if they so decide, base themselves on: \u2014 collective agreements or arbitration awards which are generally applicable to all similar undertakings in the geographical area and in the profession or industry concerned; and/or \u2014 collective agreements which have been concluded by the most representative employers' and labour organisations at national level and which are applied throughout national territory. Equality of treatment, within the meaning of paragraph 1, shall be deemed to exist where national undertakings in a similar position: (i) are subject, in the place in question or in the sector concerned, to the same obligations as posting undertakings as regards the matters listed in the first subparagraph of paragraph 1; and (ii) are required to fulfil such obligations with the same effects. Article 5 Improved access to information 1. Each Party or, in the case of the Union, each Member State shall publish the information on the terms and conditions of employment, in accordance with national law and/or practice, without undue delay and in a transparent manner, on a single official national website, including the constituent elements of remuneration as referred to in Article 4(2) and all the terms and conditions of employment in accordance with Article 4(1). Each Party or, in the case of the Union, each Member State shall ensure that the information provided on the single official national website is accurate and up to date. 2. Each Party or, in the case of the Union, each Member State shall take the appropriate measures to ensure that the information mentioned in paragraph 1 is made generally available free of charge in a clear, transparent, comprehensive and easily accessible way at a distance and by electronic means, in formats and in accordance with web accessibility standards that ensure access to persons with disabilities and to ensure that competent national bodies are in a position to carry out their tasks effectively. 3. Where, in accordance with national law, traditions and practice, including respect for the autonomy of social partners, the terms and conditions of employment referred to in Article 4 are laid down in collective agreements in accordance with Article 4(1), each Party or, in the case of the Union, each Member State shall ensure that those terms and conditions are made available in an accessible and transparent way to service providers from the other Party and to posted drivers, and shall seek the involvement of the social partners in that respect. The relevant information should, in particular, cover the different minimum rates of pay and their constituent elements, the method used to calculate the remuneration due and, where relevant, the qualifying criteria for classification in the different wage categories. 4. Where, contrary to paragraph 1, the information on the single official national website does not indicate which terms and conditions of employment are to be applied, that circumstance shall be taken into account in accordance with national law and/or practice in determining penalties in the event of infringements to this Section, to the extent necessary to ensure the proportionality of those penalties. 5. Each Party or, in the case of the Union, each Member State shall indicate the bodies and authorities to which drivers and road haulage operators can turn for general information on national law and practice applicable to them concerning their rights and obligations within their territory. Article 6 Administrative requirements, control and enforcement 1. Each Party or, in the case of the Union, each Member State may only impose the following administrative requirements and control measures with respect to the posting of drivers: (a) an obligation for the operator established in the other Party to submit a posting declaration to the national competent authorities of the Party or, in the case of the Union, of the Member State to which the driver is posted at the latest at the commencement of the posting, using from 2 February 2022 a multilingual standard form of the public interface connected to the EU Internal Market Information System (1) for administrative cooperation (IMI); that posting declaration shall consist of the following information: (i) the identity of the operator, at least in the form of the number of the valid licence where this number is available; (ii) the contact details of a transport manager or other contact person in the Party of establishment or, in the case of the Union, in the Member State of establishment to liaise with the competent authorities of the host Party or in, the case of the Union, of the Member State in which the services are provided and to send out and receive documents or notices; (iii) the identity, the address of the residence and the number of the driving licence of the driver; (iv) the start date of the driver's contract of employment, and the law applicable to it; (v) the envisaged start and end date of the posting; and (vi) the number plates of the motor vehicles; (b) an obligation for the operator to ensure that the driver has at his or her disposal in paper or electronic form and an obligation for the driver to keep and make available when requested at the roadside: (i) a copy of the posting declaration submitted, via the IMI system from 2 February 2022; (ii) evidence of the transport operations taking place in the host Party, such as an electronic consignment note (e-CMR); and (iii) the tachograph records and in particular the country symbols of the Party or, in the case of the Union, of the Member State in which the driver was present when carrying out transport operations, in accordance with registration and record-keeping requirements under Section 2 of Part B and Section 4 of Part B; (c) an obligation for the operator to send, from 2 February 2022 via the public interface connected to the IMI system, after the period of posting, at the direct request of the competent authorities of the other Party or, in the case of the Union, of a Member State where the posting took place, copies of documents referred to in point (b)(ii) and (iii) of this paragraph as well as documentation relating to the remuneration of the driver in respect of the period of posting, the employment contract or an equivalent document, time-sheets relating to the driver's work, and proof of payments. The operator shall send the documentation, from 2 February 2022 via the public interface connected to the IMI system, no later than eight weeks from the date of the request. If the operator fails to submit the requested documentation within that time period, the competent authorities of the Party or, in the case of the Union, the Member State where the posting took place may request, from 2 February 2022 via the IMI system, the assistance of the competent authorities of the Party of establishment or, in the case of the Union, the Member State of establishment. When such a request for mutual assistance is made, the competent authorities of the Party of establishment or, in the case of the Union, the Member State of establishment of the operator shall have access to the posting declaration and other relevant information submitted by the operator, from 2 February 2022 via the public interface connected to the IMI system. The competent authorities of the Party of establishment or, in the case of the Union, of the Member State of establishment shall ensure that they provide the requested documentation to the competent authorities of the Party or, in the case of the Union, to the competent authorities of the Member State where the posting took place, from 2 February 2022 via the IMI system, within 25 working days from the day of the request for mutual assistance. Each Party shall ensure that the information exchanged by the competent national authorities or transmitted to them shall be used only in respect of the matter or matters for which it was requested. Mutual administrative cooperation and assistance shall be provided free of charge. A request for information shall not preclude the competent authorities from taking measures to investigate and prevent alleged breaches of this Section. 3. For the purpose of ascertaining whether a driver is not to be considered to be posted pursuant to Article 1, each Party may only impose as a control measure an obligation for the driver to keep and make available, where requested at the roadside check, in paper or electronic form, the evidence of the relevant transport operations, such as an electronic consignment note (e-CMR), and tachograph records, as referred to in point (b)(iii) of paragraph 2 of this Article. 4. For the purposes of control, the operator shall keep the posting declarations referred to in point (a) of paragraph 2 up to date, from 2 February 2022 in the public interface connected to IMI. 5. The information from the posting declarations shall be saved, from 2 February 2022, in the IMI repository for the purpose of checks for a period of 24 months. 6. The Party or, in the case of the Union, the Member State to whose territory the driver is posted and the Party or, in the case of the Union, the Member State from which the driver is posted shall be responsible for the monitoring, control and enforcement of the obligations laid down in this Section and shall take appropriate measures in the event of failure to comply with this Section. 7. Each Party or, in the case of the Union, the Member States shall ensure that inspections and controls of compliance under this Article are not discriminatory and/or disproportionate, whilst taking into account the relevant provisions of this Section. 8. For the enforcement of the obligations under this Section, each Party or, in the case of the Union, the Member States shall ensure that there are effective mechanisms for posted drivers to lodge complaints against their employers directly, as well as the right to institute judicial or administrative proceedings, also in the Party in whose territory the drivers are or were posted, where such drivers consider they have sustained loss or damage as a result of a failure to apply the applicable rules, even after the relationship in which the failure is alleged to have occurred has ended. 9. Paragraph 8 shall apply without prejudice to the jurisdiction of the courts of each Party or, in case of the Union, the Member States as laid down, in particular, in the relevant instruments of Union law and/or international conventions. 10. Each Party or, in the case of the Union, the Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Section and shall take all measures necessary to ensure that they are implemented and complied with. The penalties provided for shall be effective, proportionate and dissuasive. Each Party shall notify those provisions to the other Party by 30 June 2021. They shall notify without delay any subsequent amendments to them. Article 7 Use of the IMI system 1. As from 2 February 2022, information, including personal data, referred to in Article 6 shall be exchanged and processed in the IMI system, provided that the following conditions are fulfilled: (a) the Parties provide safeguards that data processed in the IMI system are only used for the purpose for which they were initially exchanged; (b) any transfer of personal data to the United Kingdom under this Article may only take place in accordance with point (c) of Article 23(1) of Regulation (EU) No 1024/2012 of the European Parliament and of the Council (2); and (c) any transfer of personal data to the Union under this Article may only take place in accordance with the data protection rules on international transfers of the United Kingdom. 2. The competent authorities in each Party shall grant and revoke appropriate access rights to IMI users. 3. IMI users are allowed to access personal data processed in the IMI system only on a need-to-know basis and exclusively for the purpose of implementation and enforcement of this Section. 4. Each Party or, in the case of the Union, each Member State, may allow the competent authority to provide national social partners by other means than the IMI system with relevant information available in the IMI system to the extent necessary for the purpose of checking compliance with posting rules and in accordance with national law and practices, provided that: (a) the information relates to a posting to the territory of the Party or, in the case of the Union, of the Member State, concerned; and (b) the information is used exclusively for the purpose of enforcing the posting rules. 5. The Specialised Committee on Road Transport shall set the technical and procedural specifications of the use of the IMI system by the United Kingdom. 6. Each Party shall participate in the operating costs of the IMI system. The Specialised Committee on Road Transport shall determine the costs to be borne by each Party. PART B REQUIREMENTS FOR DRIVERS INVOLVED IN THE TRANSPORT OF GOODS IN ACCORDANCE WITH ARTICLE 465 OF THIS AGREEMENT SECTION 1 CERTIFICATE OF PROFESSIONAL COMPETENCE Article 1 Scope This Section applies to the activity of driving by anyone employed or used by a road haulage operator of a Party undertaking journeys referred to in Article 462 of this Agreement and using vehicles for which a driving licence of category C1, C1+E, C or C+E, or a driving licence recognised as equivalent by the Specialised Committee on Road Transport, is required. Article 2 Exemptions A certificate of professional competence (CPC) is not required for drivers of vehicles: (a) with a maximum authorised speed not exceeding 45 km/h; (b) used by, or under the control of, the armed forces, civil defence, the fire service, forces responsible for maintaining public order, and emergency ambulance services, when the carriage is undertaken as a consequence of the tasks assigned to those services; (c) undergoing road tests for technical development, repair or maintenance purposes, or the drivers of new or rebuilt vehicles which have not yet been put into service; (d) used in states of emergency or assigned to rescue missions; (e) carrying material, equipment or machinery to be used by the drivers in the course of their work, provided that driving the vehicles is not the drivers' principal activity; or (f) used, or hired without a driver, by agricultural, horticultural, forestry, farming or fishery undertakings for carrying goods as part of their own entrepreneurial activity, except if driving is part of the driver's principal activity or the driving exceeds a distance set in national law from the base of the undertaking which owns, hires or leases the vehicle. Article 3 Qualification and training 1. The activity of driving as defined in Article 1 shall be subject to a compulsory initial qualification and to compulsory periodic training. To that end the Parties shall provide for: (a) a system of initial qualification corresponding to one of the following two options: (i) option combining both course attendance and a test In accordance with Section 2(2.1) of Appendix 31-B-1-1, this type of initial qualification involves compulsory course attendance for a specific period. It shall conclude with a test. Upon successful completion of the test, the qualification shall be certified by a CPC as provided for in point (a) of Article 6(1); (ii) option involving only tests In accordance with Section 2(2.2) of Appendix 31-B-1-1, this type of initial qualification does not involve compulsory course attendance but only theoretical and practical tests. Upon successful completion of the tests, the qualification shall be certified by a CPC as provided for in point (b) of Article 6(1). However, a Party may authorise a driver to drive within its territory before obtaining a CPC, where the driver is undergoing a national vocational training course of at least six months, for a maximum period of three years. In the context of that vocational training course, the tests referred to in points (i) and (ii) of this point may be completed in stages; (b) a system of periodic training In accordance with Section 4 of Appendix 31-B-1-1, periodic training involves compulsory course attendance. It shall be certified by a CPC as provided for in Article 8(1). 2. A Party may also provide for a system of accelerated initial qualification so that a driver may drive in the cases referred to in points (a)(ii) and (b) of Article 5(2). In accordance with Section 3 of Appendix 31-B-1-1, the accelerated initial qualification shall involve compulsory course attendance. It shall conclude with a test. Upon successful completion of the test, the qualification shall be certified by a CPC as provided for in Article 6(2). 3. A Party may exempt drivers who have obtained the certificate of professional competence provided for in Article 8 of Section 1 of Part A from the tests referred to in points (a)(i) and (ii) of paragraph 1 and in paragraph 2 of this Article in the subjects covered by the test provided for in that part of this Annex and, where appropriate, from attending the part of the course corresponding thereto. Article 4 Acquired rights Drivers who hold a category C1, C1+E, C or C+E licence, or a licence recognised as equivalent by the Specialised Committee on Road Transport, issued no later than 10 September 2009, shall be exempted from the need to obtain an initial qualification. Article 5 Initial qualification 1. Access to an initial qualification shall not require the corresponding driving licence to be obtained beforehand. 2. Drivers of a vehicle intended for the carriage of goods may drive: (a) from the age of 18: (i) a vehicle in licence categories C and C+E, provided they hold a CPC as referred to in Article 6(1); and (ii) a vehicle in licence categories C1 and C1+E, provided they hold a CPC as referred to in Article 6(2); (b) from the age of 21, a vehicle in licence categories C and C+E, provided they hold a CPC as referred to in Article 6(2). 3. Without prejudice to the age limits specified in paragraph 2, drivers undertaking carriage of goods who hold a CPC as provided for in Article 6 for one of the categories provided for in paragraph 2 of this Article shall be exempted from obtaining such a CPC for any other of the categories of vehicles referred to in that paragraph. 4. Drivers undertaking carriage of goods who broaden or modify their activities in order to carry passengers, or vice versa, and who hold a CPC as provided for in Article 6, shall not be required to repeat the common parts of the initial qualification, but rather only the parts specific to the new qualification. Article 6 CPC certifying the initial qualification 1. CPC certifying an initial qualification (a) CPC awarded on the basis of course attendance and a test In accordance with point (a)(i) of Article 3(1), the Parties shall require trainee drivers to attend courses in a training centre approved by the competent authorities in accordance with Section 5 of Appendix 31-B-1-1, hereinafter referred to as \"approved training centre\". Those courses shall cover all the subjects referred to in Section 1 of Appendix 31-B-1-1. That training shall conclude with successful completion of the test provided for in Section 2(2.1) of Appendix 31-B-1-1. That test shall be organised by the competent authorities in the Parties or an entity designated by them and shall serve to check whether, for the aforementioned subjects, the trainee driver has the level of knowledge required in Section 1 of Appendix 31-B-1-1. The said authorities or entities shall supervise the test and, upon successful completion, issue the drivers with a CPC certifying an initial qualification. (b) CPC awarded on the basis of tests In accordance with point (a)(ii) of Article 3(1), the Parties shall require trainee drivers to pass the theoretical and practical tests referred to in Section 2(2.2) of Appendix 31-B-1-1. Those tests shall be organised by the competent authorities in the Parties or an entity designated by them and shall serve to check whether, for all the aforementioned subjects, the trainee driver has the level of knowledge required in Section 1 of Appendix 31-B-1-1. The said authorities or entities shall supervise the tests and, upon successful completion, issue the drivers with a CPC certifying an initial qualification. 2. CPC certifying an accelerated initial qualification In accordance with Article 3(2), the Parties shall require trainee drivers to attend courses in an approved training centre. Those courses shall cover all the subjects referred to in Section 1 of Appendix 31-B-1-1. That training shall conclude with the test provided for in Section 3 of Appendix 31-B-1-1. That test shall be organised by the competent authorities in the Parties or an entity designated by them and shall serve to check whether, for the aforementioned subjects, the trainee driver has the level of knowledge required in Section 1 of Appendix 31-B-1-1. The said authorities or entities shall supervise the test and, upon successful completion, issue the drivers with a CPC certifying an accelerated initial qualification. Article 7 Periodic training Periodic training shall consist of training to enable holders of a CPC to update the knowledge which is essential for their work, with specific emphasis on road safety, health and safety at work, and the reduction of the environmental impact of driving. That training shall be organised by an approved training centre, in accordance with Section 5 of Appendix 31-B-1-1. Training shall consist of classroom teaching, practical training and, if available, training by means of information and communication technology (ICT) tools or on top-of-the-range simulators. If a driver moves to another undertaking, the periodic training already undergone must be taken into account. Periodic training shall be designed to expand on, and to revise, some of the subjects referred in Section 1 of Appendix 31-B-1-1. It shall cover a variety of subjects and shall always include at least one road safety related subject. The training subjects shall take into account developments in the relevant legislation and technology, and shall, as far as possible, take into account the specific training needs of the driver. Article 8 CPC certifying periodic training 1. When a driver has completed the periodic training referred to in Article 7, the competent authorities in the Parties or the approved training centre shall issue him or her with a CPC certifying periodic training. 2. The following drivers shall undergo a first course of periodic training: (a) holders of a CPC as referred to in Article 6, within five years of the issue of that CPC; and (b) the drivers referred to in Article 4, within five years of 10 September 2009. A Party may reduce or extend the periods of time referred to in point (a) or (b) by a maximum of two years. 3. A driver who has completed a first course of periodic training as referred to in paragraph 2 of this Article shall undergo periodic training every five years, before the end of the period of validity of the CPC certifying periodic training. 4. Holders of the CPC as referred to in Article 6 or the CPC as referred to in paragraph 1 of this Article and the drivers referred to in Article 4 who have ceased pursuit of the occupation and do not meet the requirements of paragraphs 1, 2 and 3 of this Article, shall undergo a course of periodic training before resuming pursuit of the occupation. 5. Drivers undertaking the carriage of goods by road who have completed courses of periodic training for one of the licence categories provided for in Article 5(2) shall be exempt from the obligation to undergo further periodic training for another of the categories provided for in that paragraph. Article 9 Enforcement The competent authorities in a Party shall either affix directly on the driver's driving permit (licence), beside the corresponding categories of licence, a distinguishing sign attesting to the possession of a CPC and indicating the date of expiry, or introduce a special driver qualification card which should be drawn up in accordance with the model reproduced in Appendix 31-B-1-2. Any other model may be acceptable provided that it is recognised as equivalent by the Specialised Committee on Road Transport. The driver qualification card or any equivalent document as specified above issued by the competent authorities in a Party shall be recognised by the other Party for the purposes of this Section. Drivers must be able to present, at the request of any authorised inspecting officer, a driving permit (licence) or a specific driver qualification card or equivalent document bearing the distinguishing sign confirming possession of a CPC. Appendix 31-B-1-1 MINIMUM QUALIFICATION AND TRAINING REQUIREMENTS To ensure that the rules governing the transport of goods by road covered by Title I of Heading Three of Part Two of this Agreement are as harmonised as possible, the minimum requirements for driver qualification and training as well as the approval of training centres are set out in Sections 1 to 5 of this Appendix. Any other content for this qualification or training may be acceptable provided that it is considered as equivalent by the Specialised Committee on Road Transport. SECTION 1 LIST OF SUBJECTS The knowledge to be taken into account by the Parties when establishing the driver's initial qualification and periodic training must include at least the subjects in this list. Trainee drivers must reach the level of knowledge and practical competence necessary to drive in all safety vehicles of the relevant licence category. The minimum level of knowledge may not be less than the level reached during compulsory education, supplemented by professional training. 1. Advanced training in rational driving based on safety regulations 1.1 Objective: to know the characteristics of the transmission system in order to make the best possible use of it: curves relating to torque, power, and specific consumption of an engine, area of optimum use of revolution counter, gearbox-ratio cover diagrams. 1.2 Objective: to know the technical characteristics and operation of the safety controls in order to control the vehicle, minimise wear and tear, and prevent disfunctioning: limits to the use of brakes and retarder, combined use of brakes and retarder, making better use of speed and gear ratio, making use of vehicle inertia, using ways of slowing down and braking on downhill stretches, action in the event of failure, use of electronic and mechanical devices such as Electronic Stability Program (ESP), Advanced Emergency Braking Systems (AEBS), Anti-Lock Braking System (ABS), traction control systems (TCS) and in vehicle monitoring systems (IVMS) and other, approved for use, driver assistance or automation devices. 1.3 Objective: ability to optimise fuel consumption: optimisation of fuel consumption by applying know-how as regards points 1.1 and 1.2, importance of anticipating traffic flow, appropriate distance to other vehicles and use of the vehicle's momentum, steady speed, smooth driving style and appropriate tyre pressure, and familiarity with intelligent transport systems that improve driving efficiency and assist in route planning. 1.4 Objective: ability to anticipate, assess and adapt to risks in traffic: to be aware of and adapt to different road, traffic and weather conditions, anticipate forthcoming events; to understand how to prepare and plan a journey during abnormal weather conditions; to be familiar with the use of related safety equipment and to understand when a journey has to be postponed or cancelled due to extreme weather conditions; to adapt to the risks of traffic, including dangerous behaviour in traffic or distracted driving (through the use of electronic devices, eating, drinking, etc.); to recognise and adapt to dangerous situations and to be able to cope with stress deriving therefrom, in particular related to size and weight of the vehicles and vulnerable road users, such as pedestrians, cyclists and powered two wheelers; to identify possible hazardous situations and properly interpret how those potentially hazardous situations may turn into situations where crashes can no longer be averted and selecting and implementing actions that increase the safety margins to such an extent that a crash can still be averted in case the potential hazards should occur. 1.5 Objective: ability to load the vehicle with due regard for safety rules and proper vehicle use: forces affecting vehicles in motion, use of gearbox ratios according to vehicle load and road profile, use of automatic transmission systems, calculation of payload of vehicle or assembly, calculation of total volume, load distribution, consequences of overloading the axle, vehicle stability and centre of gravity, types of packaging and pallets; main categories of goods needing securing, clamping and securing techniques, use of securing straps, checking of securing devices, use of handling equipment, placing and removal of tarpaulins. 2. Application of regulations 2.1 Objective: to know the social environment of road transport and the rules governing it: maximum working periods specific to the transport industry; principles, application and consequences of the rules related to the driving times and rest periods and those related to the tachograph; penalties for failure to use, improper use of and tampering with the tachograph; knowledge of the social environment of road transport: rights and duties of drivers as regards initial qualification and periodic training. 2.2 Objective: to know the regulations governing the carriage of goods: transport operating licences, documents to be carried in the vehicle, bans on using certain roads, road-use fees, obligations under standard contracts for the carriage of goods, drafting of documents which form the transport contract, international transport permits, obligations under the CMR Convention on the Contract for the International Carriage of Goods by Road, done in Geneva on 19 May 1956, drafting of the international consignment note, crossing borders, freight forwarders, special documents accompanying goods. 3. Health, road and environmental safety, service, logistics 3.1 Objective: to make drivers aware of the risks of the road and of accidents at work: types of accidents at work in the transport sector, road accident statistics, involvement of lorries/coaches, human, material and financial consequences. 3.2 Objective: ability to prevent criminality and trafficking in illegal immigrants: general information, implications for drivers, preventive measures, check list, legislation on transport operator liability. 3.3 Objective: ability to prevent physical risks: ergonomic principles; movements and postures which pose a risk, physical fitness, handling exercises, personal protection. 3.4 Objective: awareness of the importance of physical and mental ability: principles of healthy, balanced eating, effects of alcohol, drugs or any other substance likely to affect behaviour, symptoms, causes, effects of fatigue and stress, fundamental role of the basic work/rest cycle. 3.5 Objective: ability to assess emergency situations: behaviour in an emergency situation: assessment of the situation, avoiding complications of an accident, summoning assistance, assisting casualties and giving first aid, reaction in the event of fire, evacuation of occupants of a lorry, reaction in the event of aggression; basic principles for the drafting of an accident report. 3.6 Objective: ability to adopt behaviour to help enhance the image of the company: behaviour of the driver and company image: importance for the company of the standard of service provided by the driver, the roles of the driver, people with whom the driver will be dealing, vehicle maintenance, work organisation, commercial and financial effects of a dispute. 3.7 Objective: to know the economic environment of road haulage and the organisation of the market: road transport in relation to other modes of transport (competition, shippers), different road transport activities (transport for hire or reward, own account, auxiliary transport activities), organisation of the main types of transport company and auxiliary transport activities, different transport specialisations (road tanker, controlled temperature, dangerous goods, animal transport, etc.), changes in the industry (diversification of services provided, rail-road, subcontracting, etc.). SECTION 2 COMPULSORY INITIAL QUALIFICATION PROVIDED FOR IN POINT (a) OF ARTICLE 3(1) OF SECTION 1 OF PART B A Party may count specific other training related to the transport of goods by road required under its legislation as part of the training under this Section and under Section 3 of this Appendix. 2.1. Option combining both course attendance and a test Initial qualification must include the teaching of all subjects in the list under Section 1 of this Appendix. The duration of that initial qualification must be 280 hours. Each trainee driver must drive for at least 20 hours individually in a vehicle of the category concerned which meets at least the requirements for test vehicles. When driving individually, the trainee driver must be accompanied by an instructor, employed by an approved training centre. Each trainee driver may drive for a maximum of eight hours of the 20 hours of individual driving on special terrain or on a top-of-the-range simulator so as to assess training in rational driving based on safety regulations, in particular with regard to vehicle handling in different road conditions and the way they change with different atmospheric conditions, the time of day or night, and the ability to optimise fuel consumption. A Party and, in the case of the Union, a Member State may allow part of the training to be delivered by the approved training centre by means of ICT tools, such as e-learning, while ensuring that the high quality and the effectiveness of the training are maintained, and by selecting the subjects where ICT tools can most effectively be deployed. Reliable user identification and appropriate means of control shall be required in such a case. For the drivers referred to in Article 5(4) of Section 1 of Part B the length of the initial qualification must be 70 hours, including five hours of individual driving. At the end of that training, the competent authorities in the Parties or the entity designated by them shall give the driver a written or oral test. The test must include at least one question on each of the objectives in the list of subjects under Section 1 of this Appendix. 2.2 Option involving a test The competent authorities in the Parties or the entity designated by them shall organise the aforementioned theoretical and practical tests to check whether the trainee driver has the level of knowledge required in Section 1 of this Appendix for the subjects and objectives listed there. (a) The theoretical test shall consist of at least two parts: (i) questions including multiple-choice questions, questions requiring a direct answer, or a combination of both; and (ii) case studies. The minimum duration of the theoretical test must be four hours. (b) The practical test shall consist of two parts: (i) a driving test aimed at assessing training in rational driving based on safety regulations. The test must take place, whenever possible, on roads outside built-up areas, on fast roads and on motorways (or similar), and on all kinds of urban highways presenting the different types of difficulties that a driver is liable to encounter. It would be desirable for that test to take place in different traffic density conditions. The driving time on the road must be used optimally in order to assess the candidate in all traffic areas likely to be encountered. The minimum duration of that test must be 90 minutes; (ii) a practical test covering at least points 1.5, 3.2, 3.3 and 3.5 of Section 1 of this Appendix. The minimum duration of that test must be 30 minutes. The vehicle used for the practical test must meet at least the requirements for test vehicles. The practical test may be supplemented by a third test taking place on special terrain or on a top-of the-range simulator so as to assess training in rational driving based on safety regulations, in particular with regard to vehicle handling in different road conditions and the way they change with different atmospheric conditions and the time of day or night. The duration of that optional test is not fixed. Should the driver undergo such a test, its duration may be deducted from the 90 minutes of the driving test referred to under point (i), but the time deducted may not exceed 30 minutes. For the drivers referred to in Article 5(4) of Section 1 of Part B, the theoretical test must be limited to the subjects, referred to in Section 1 of this Appendix, which are relevant to the vehicles to which the new initial qualification applies. However, such drivers must undergo the whole practical test. SECTION 3 ACCELERATED INITIAL QUALIFICATION PROVIDED FOR IN ARTICLE 3(2) OF SECTION 1 OF PART B OF ANNEX 31 Accelerated initial qualification must include the teaching of all subjects in the list in Section 1 of this Appendix. Its duration must be 140 hours. Each trainee driver must drive for at least 10 hours individually in a vehicle of the category concerned which meets at least the requirements for test vehicles. When driving individually, the trainee driver must be accompanied by an instructor, employed by an approved training centre. Each trainee driver may drive for a maximum of four hours of the 10 hours of individual driving on special terrain or on a top-of-the-range simulator so as to assess training in rational driving based on safety regulations, in particular with regard to vehicle handling in different road conditions and the way those road conditions change with different atmospheric conditions, the time of day or night, and the ability to optimise fuel consumption. The provisions of the fourth paragraph of point 2.1 of Section 2 of this Appendix shall also apply to the accelerated initial qualification. For the drivers referred to in Article 5(4) of Section 1 of Part B, the length of the accelerated initial qualification must be 35 hours, including two-and-a-half hours of individual driving. At the end of that training, the competent authorities in the Parties or the entity designated by them shall give the driver a written or oral test. The test must include at least one question on each of the objectives in the list of subjects under Section 1 of this Appendix. A Party may count specific other training related to the transport of goods by road required under its legislation as part of the training under this Section. SECTION 4 COMPULSORY PERIODIC TRAINING PROVIDED FOR IN POINT (b) OF ARTICLE 3(1) OF SECTION 1 OF PART B OF ANNEX 31 Compulsory periodic training courses must be organised by an approved training centre. Their duration must be of 35 hours every five years, given in periods of at least seven hours, which may be split over two consecutive days. Whenever e- learning is used, the approved training centre shall ensure that the proper quality of the training is maintained, including by selecting the subjects where ICT tools can most effectively be deployed. In particular, the Parties shall require reliable user identification and appropriate means of control. The maximum duration of the e-learning training shall not exceed 12 hours. At least one of the training course periods shall cover a road safety related subject. The content of the training shall take into account training needs specific to the transport operations carried out by the driver and relevant legal and technological developments and should, as far as possible, take into account specific training needs of the driver. A range of different subjects should be covered over the 35 hours, including repeat training where it is shown that the driver needs specific remedial training. A Party and, in the case of the Union, a Member State may count specific other training related to the transport of goods by road required under its legislation as part of the training under this Section. SECTION 5 APPROVAL OF THE INITIAL QUALIFICATION AND PERIODIC TRAINING 5.1. The training centres taking part in the initial qualification and periodic training must be approved by the competent authorities in the Parties. Approval may be given only in response to a written application. The application must be accompanied by documents including: 5.1.1. a suitable qualification and training programme specifying the subjects taught and setting out the proposed implementing plan and teaching methods; 5.1.2. the instructors' qualifications and fields of activity; 5.1.3. information about the premises where the courses are given, the teaching materials, the resources made available for the practical work, and the vehicle fleet used; 5.1.4. the conditions regarding participation in the courses (number of participants). 5.2. The competent authority must give approval in writing subject to the following conditions: 5.2.1. the training must be given in accordance with the documents accompanying the application; 5.2.2. the competent authority must be entitled to send authorised persons to assist in the training courses of the approved centres, and must be entitled to monitor such centres, with regard to the resources used and the proper running of the training courses and tests; 5.2.3. the approval may be withdrawn or suspended if the conditions of approval are no longer complied with. The approved centre must guarantee that the instructors have a sound knowledge of the most recent regulations and training requirements. As part of a specific selection procedure, the instructors must provide certification showing a knowledge of both the subject material and teaching methods. As regards the practical part of the training, instructors must provide certification of experience as professional drivers or similar driving experience, such as that of driving instructors for heavy vehicles. The programme of instruction must be in accordance with the approval and must cover the subjects in the list in Section 1. Appendix 31-B-1-2 MODEL OF A DRIVER QUALIFICATION CARD REFERRED TO IN ARTICLE 9 OF SECTION 1 OF PART B OF THIS ANNEX SECTION 2 DRIVING TIMES, BREAKS AND REST PERIODS Article 1 Scope 1. This Section lays down the rules on driving time, breaks and rest periods for drivers referred to in point (b) of Article 465(1) of this Agreement undertaking journeys referred to in Article 462 of this Agreement. 2. Where a driver undertakes a journey referred to in Article 462 of this Agreement, the rules in this Section apply to any road transport operation undertaken by that driver between the territories of the Parties and between Member States. 3. This Section applies: (a) where the maximum permissible mass of the vehicle, including any trailer, or semitrailer, exceeds 3.5 tonnes; or (b) from 1 July 2026, where the maximum permissible mass of the vehicle, including any trailer, or semi-trailer, exceeds 2.5 tonnes. 4. This Section does not apply to transport by: (a) vehicles or combinations of vehicles with a maximum permissible mass not exceeding 7.5 tonnes used for: (i) carrying materials, equipment or machinery for the driver's use in the course of the driver's work, or (ii) for delivering goods which are produced on a craft basis, only within a 100 km radius from the base of the undertaking and on the condition that driving the vehicle does not constitute the driver's main activity and transport is not carried out for hire or reward; (b) vehicles with a maximum authorised speed not exceeding 40 km/h; (c) vehicles owned or hired without a driver by the armed services, civil defence services, fire services, and forces responsible for maintaining public order when the transport is undertaken as a consequence of the tasks assigned to those services and is under their control; (d) vehicles used in emergencies or rescue operations; (e) specialised vehicles used for medical purposes; (f) specialised breakdown vehicles operating within a 100 km radius of their base; (g) vehicles undergoing road tests for technical development, repair or maintenance purposes, and new or rebuilt vehicles which have not yet been put into service; (h) vehicles with a maximum permissible mass, including any trailer, or semi-trailer exceeding 2.5 tonnes but not exceeding 3.5 tonnes that are used for the transport of goods, where the transport is not effected for hire or reward, but on the own account of the company or the driver, and where driving does not constitute the main activity of the person driving the vehicle; (i) commercial vehicles, which have a historic status according to the legislation of the Member State in which they are being driven and which are used for the non-commercial transport of goods. Article 2 Definitions For the purposes of this Section, the following definitions apply: (a) \"transport by road\" means any journey made entirely or in part on roads open to the public by a vehicle, whether laden or not; (b) \"break\" means any period during which a driver may not carry out any driving or any other work and which is used exclusively for recuperation; (c) \"other work\" means all activities which are defined as working time in point (a) of Article 2(1) of Section 3 of Part B except \"driving\", including any work for the same or another employer, within or outside of the transport sector; (d) \"rest\" means any uninterrupted period during which a driver may freely dispose of his or her time; (e) \"daily rest period\" means the daily period during which a driver may freely dispose of his or her time and covers a \"regular daily rest period\" and a \"reduced daily rest period\": (i) \"regular daily rest period\" means any period of rest of at least 11 hours, which may be taken in two periods, the first of which must be an uninterrupted period of at least 3 hours and the second an uninterrupted period of at least nine hours; and (ii) \"reduced daily rest period\" means any period of rest of at least nine hours but less than 11 hours; (f) \"weekly rest period\" means the weekly period during which a driver may freely dispose of his or her time and covers a \"regular weekly rest period\" and a \"reduced weekly rest period\": (i) \"regular weekly rest period\" means any period of rest of at least 45 hours; and (ii) \"reduced weekly rest period\" means any period of rest of less than 45 hours, which may, subject to the conditions laid down in Article 6(6) and 6(7), be shortened to a minimum of 24 consecutive hours; (g) \"a week\" means the period of time between 00.00 on Monday and 24.00 on Sunday; (h) \"driving time\" means the duration of driving activity recorded: (i) automatically or semi-automatically by the tachograph as defined in points (e), (f), (g) and (h) of Article 2 of Section 4 of Part B of this Annex; or (ii) manually as required by Article 9(2) and Article 11 of Section 4 of Part B of this Annex; (i) \"daily driving time\" means the total accumulated driving time between the end of one daily rest period and the beginning of the following daily rest period or between a daily rest period and a weekly rest period; (j) \"weekly driving time\" means the total accumulated driving time during a week; (k) \"maximum permissible mass\" means the maximum authorised operating mass of a vehicle when fully laden; (l) \"multi-manning\" means the situation where, during each period of driving between any two consecutive daily rest periods, or between a daily rest period and a weekly rest period, there are at least two drivers in the vehicle to do the driving for the first hour of multimanning the presence of another driver or drivers is optional but for the remainder of the period it is compulsory; (m) \"driving period\" means the accumulated driving time from when a driver commences driving following a rest period or a break until the driver takes a rest period or a break; the driving period may be continuous or broken. Article 3 Requirement for drivers\u2019 mates The minimum age for drivers' mates shall be 18 years. However, each Party and, in the case of the Union, a Member State may reduce the minimum age for drivers' mates to 16 years, provided that the reduction is for the purposes of vocational training and there is compliance with the limits imposed by the United Kingdom and, for the Union, the Member State's national rules on employment matters. Article 4 Driving times 1. The daily driving time shall not exceed nine hours. However, the daily driving time may be extended to at most 10 hours not more than twice during the week. 2. The weekly driving time shall not exceed 56 hours and shall not result in the maximum weekly working time of 60 hours being exceeded. 3. The total accumulated driving time during any two consecutive weeks shall not exceed 90 hours. 4. Daily and weekly driving times shall include all driving time on the territory of the Parties. 5. A driver shall record as other work any time spent as described in point (c) of Article 2 of this Section as well as any time spent driving a vehicle used for commercial operations where a driver is not required to record driving time, and shall record any periods of availability, as defined in point (2) of Article 2 of Section 3 of Part B, in accordance with point (b)(iii) of Article 6(5) of Section 4 of Part B. This record shall be entered either manually on a record sheet or printout or by use of manual input facilities on recording equipment. Article 5 Breaks After a driving period of four and a half hours a driver shall take an uninterrupted break of not less than 45 minutes, unless the driver takes a rest period. That break may be replaced by a break of at least 15 minutes followed by a break of at least 30 minutes each distributed over the period in such a way as to comply with the provisions of the first paragraph. A driver engaged in multi-manning may take a break of 45 minutes in a vehicle driven by another driver provided that the driver taking the break is not involved in assisting the driver driving the vehicle. Article 6 Rests 1. A driver shall take daily and weekly rest periods. 2. Within each period of 24 hours after the end of the previous daily rest period or weekly rest period a driver shall have taken a new daily rest period. If the portion of the daily rest period which falls within that 24-hour period is at least nine hours but less than 11 hours, then the daily rest period in question shall be regarded as a reduced daily rest period. 3. A daily rest period may be extended to make a regular weekly rest period or a reduced weekly rest period. 4. A driver may have at most three reduced daily rest periods between any two weekly rest periods. 5. By way of derogation from paragraph 2, within 30 hours of the end of a daily or weekly rest period, a driver engaged in multi-manning must have taken a new daily rest period of at least nine hours. 6. In any two consecutive weeks a driver shall take at least: (a) two regular weekly rest periods; or (b) one regular weekly rest period and one reduced weekly rest period of at least 24 hours. A weekly rest period shall start no later than at the end of six 24-hour periods from the end of the previous weekly rest period. 7. By way of derogation from paragraph 6, a driver engaged in international transport of goods may, outside the territory of the Party of the road haulage operator or, for drivers of Union road haulage operators, outside the territory of the Member State of the road haulage operator, take two consecutive reduced weekly rest periods provided that the driver in any four consecutive weeks takes at least four weekly rest periods, of which at least two shall be regular weekly rest periods. For the purpose of this paragraph, a driver shall be considered to be engaged in international transport where the driver starts the two consecutive reduced weekly rest periods outside the territory of the Party of the road haulage operator and drivers' place of residence or, for the Union, outside the territory of the Member State of the road haulage operator and the country of the drivers' place of residence. Any reduction in weekly rest period shall be compensated by an equivalent period of rest taken en bloc before the end of the third week following the week in question. Where two reduced weekly rest periods have been taken consecutively in accordance with the third subparagraph, the next weekly rest period shall be preceded by a rest period taken as compensation for those two reduced weekly rest periods. 8. Any rest taken as compensation for a reduced weekly rest period shall be attached to another rest period of at least nine hours. 9. The regular weekly rest periods and any weekly rest period of more than 45 hours taken in compensation for previous reduced weekly rest periods shall not be taken in a vehicle. They shall be taken in suitable gender-friendly accommodation with adequate sleeping and sanitary facilities. Any costs for accommodation outside the vehicle shall be covered by the employer. 10. Transport undertakings shall organise the work of drivers in such a way that the drivers are able to return to the employer's operational centre where the driver is normally based and where the driver's weekly rest period begins, in the United Kingdom and, in the case of the Union, the Member State of the employer's establishment, or to return to the drivers' place of residence, within each period of four consecutive weeks, in order to spend at least one regular weekly rest period or a weekly rest period of more than 45 hours taken in compensation for reduced weekly rest period. However, where the driver has taken two consecutive reduced weekly rest periods in accordance with paragraph 7, the transport undertaking shall organise the work of the driver in such a way that the driver is able to return before the start of the regular weekly rest period of more than 45 hours taken in compensation. The undertaking shall document how it fulfils that obligation and shall keep the documentation at its premises in order to present it at the request of control authorities. 11. A weekly rest period that falls in two weeks may be counted in either week, but not in both. 12. By way of derogation, where a driver accompanies a vehicle which is transported by ferry or train and takes a regular daily rest period or a reduced weekly rest period, that period may be interrupted not more than twice by other activities not exceeding one hour in total. During that regular daily rest or reduced weekly rest period the driver shall have access to a sleeper cabin, bunk or couchette at their disposal. With regard to regular weekly rest periods, that derogation shall only apply to ferry or train journeys where: (a) the journey is scheduled for 8 hours or more; and (b) the driver has access to a sleeper cabin in the ferry or on the train. 13. Any time spent travelling to a location to take charge of a vehicle falling within the scope of this Section, or to return from that location, when the vehicle is neither at the driver's home nor at the employer's operational centre where the driver is normally based, shall not be counted as a rest or break unless the driver is on a ferry or train and has access to a sleeper cabin, bunk or couchette. 14. Any time spent by a driver driving a vehicle which falls outside the scope of this Section to or from a vehicle which falls within the scope of this Section, which is not at the driver's home or at the employer's operational centre where the driver is normally based, shall count as other work. Article 7 Liability of road haulage operators 1. A road haulage operator of a Party shall not give drivers it employs or who are put at its disposal any payment, even in the form of a bonus or wage supplement, related to distances travelled, the speed of delivery and/or the amount of goods carried if that payment is of such a kind as to endanger road safety and/or encourages infringement of this Section. 2. A road haulage operator of a Party shall organise road transport operations and properly instruct crew members so that they are able to comply with the provisions of this Section. 3. A road haulage operator of a Party shall be liable for infringements committed by drivers of the operator, even if the infringement was committed on the territory of the other Party. Without prejudice to the right of the Parties to hold road haulage operators fully liable, the Parties may make this liability conditional on the operator's infringement of paragraphs 1 and 2. The Parties may consider any evidence that the road haulage operator cannot reasonably be held responsible for the infringement committed. 4. Road haulage operators, consignors, freight forwarders, principal contractors, subcontractors and driver employment agencies shall ensure that contractually agreed transport time schedules respect this Section. 5. A road haulage operator which uses vehicles that are fitted with recording equipment complying with point (f), (g) or (h) of Article 2 of Section 4 of Part B and that fall within the scope of this Section, shall: (i) ensure that all data are downloaded from the vehicle unit and driver card as regularly as is stipulated by the Party and that relevant data are downloaded more frequently so as to ensure that all data concerning activities undertaken by or for that road haulage operator are downloaded; and (ii) ensure that all data downloaded from both the vehicle unit and driver card are kept for at least 12 months following recording and, should an inspecting officer request it, such data are accessible, either directly or remotely, from the premises of the road haulage operator. For the purposes of this paragraph 'downloaded' shall be interpreted in accordance with the definition laid down in point (h) of Article 2(2) of Section 2 of Part C. The maximum period within which the relevant data shall be downloaded under point (i) of this paragraph shall be 90 days for data from the vehicle unit and 28 days for data from the driver card. Article 8 Exceptions 1. Provided that road safety is not thereby jeopardised and to enable the vehicle to reach a suitable stopping place, the driver may depart from Articles 4, 5 and 6 to the extent necessary to ensure the safety of persons, of the vehicle or its load. The driver shall indicate the reason for such departure manually on the record sheet of the recording equipment or on a printout from the recording equipment or in the duty roster, at the latest on arrival at the suitable stopping place. 2. Provided that road safety is not thereby jeopardised, in exceptional circumstances, the driver may also depart from Article 4(1) and (2) and from Article 6(2) by exceeding the daily and weekly driving time by up to one hour in order to reach the employer's operational centre or the driver's place of residence to take a weekly rest period. Under the same conditions, the driver may exceed the daily and weekly driving time by up to two hours, provided that an uninterrupted break of 30 minutes was taken immediately prior to the additional driving in order to reach the employer's operational centre or the driver's place of residence for taking a regular weekly rest period. The driver shall indicate the reason for such departure manually on the record sheet of the recording equipment, or on a printout from the recording equipment or in the duty roster, at the latest on arrival at the destination or the suitable stopping place. Any period of extension shall be compensated by an equivalent period of rest taken en bloc with any rest period, by the end of the third week following the week in question. 3. Provided that road safety is not thereby jeopardised, each Party and, in the case of the Union, a Member State may grant exceptions from Articles 3 to 6 and make such exceptions subject to individual conditions on its own territory or, with the agreement of the other Party, on the territory of the other Party, applicable to transport by the following: (a) vehicles owned or hired, without a driver, by public authorities to undertake transport by road which do not compete with private road haulage operators; (b) vehicles used or hired, without a driver, by agricultural, horticultural, forestry, farming or fishery undertakings for carrying goods as part of their own entrepreneurial activity within a radius of up to 100 km from the base of the undertaking; (c) agricultural tractors and forestry tractors used for agricultural or forestry activities, within a radius of up to 100 km from the base of the undertaking which owns, hires or leases the vehicle; (d) vehicles or combinations of vehicles with a maximum permissible mass not exceeding 7.5 tonnes used by universal service providers to deliver items as part of the universal service. Those vehicles shall be used only within a 100 km radius from the base of the undertaking, and on condition that driving the vehicles does not constitute the driver's main activity; (e) vehicles operating exclusively on islands not exceeding 2 300 square kilometres in area which are not linked to the rest of the national territory by a bridge, ford or tunnel open for use by motor vehicles; (f) vehicles used for the transport of goods within a 100 km radius from the base of the undertaking and propelled by means of natural or liquefied gas or electricity, the maximum permissible mass of which, including the mass of a trailer or semi-trailer, does not exceed 7.5 tonnes; (g) vehicles used in connection with sewerage, flood protection, water, gas and electricity maintenance services, road maintenance and control, door-to-door household refuse collection and disposal, telegraph and telephone services, radio and television broadcasting, and the detection of radio or television transmitters or receivers; (h) specialised vehicles transporting circus and funfair equipment; (i) specially fitted mobile project vehicles, the primary purpose of which is use as an educational facility when stationary; (j) vehicles used for milk collection from farms and/or for the return to farms of milk containers or milk products intended for animal feed; (k) specialised vehicles transporting money and/or valuables; (l) vehicles used for carrying animal waste or carcasses which are not intended for human consumption; (m) vehicles used exclusively on roads inside hub facilities such as ports, interports and railway terminals; (n) vehicles used for the transport of live animals from farms to local markets and vice versa or from markets to local slaughterhouses within a radius of up to 100 km; (o) vehicles or combinations of vehicles carrying construction machinery for a construction undertaking, up to a radius of 100 km from the base of the undertaking, provided that driving the vehicles does not constitute the driver's main activity; and (p) vehicles used for the delivery of ready-mixed concrete. 4. Provided that working conditions of drivers and road safety are not thereby jeopardised and that the limits set out in Article 3 of Section 3 of Part B are complied with, a Party, and in the case of the Union, a Member State, may grant temporary exceptions from the application of Articles 4, 5 and 6 of this Section to transport operations carried out in exceptional circumstances, in accordance with the procedure applicable in the Party. The temporary exceptions shall be duly reasoned and notified immediately to the other Party. The Specialised Committee on Road Transport shall specify the modalities of that notification. Each Party shall immediately publish that information on a public website and shall ensure that its enforcement activities to take into account an exception granted by the other Party. SECTION 3 WORKING TIME OF MOBILE WORKERS Article 1 Scope 1. This Section applies to mobile workers employed by road haulage operators of the Parties, undertaking journeys referred to in Article 462 of this Agreement. This Section shall also apply to self-employed drivers. 2. In so far as this Section contains more specific provisions as regards mobile workers performing road transport activities it shall take precedence over the relevant provisions of Article 387 of this Agreement. 3. This Section shall supplement the provisions of Section 2 of Part B which take precedence over the provisions of this Section. 4. A Party may disapply the application of this Section for mobile workers and self-employed drivers undertaking no more than two return journeys in accordance with Article 462 of this Agreement in a calendar month. 5. Where a Party disapplies the application of this Section under paragraph 4, that Party shall notify the other Party. Article 2 Definitions For the purposes of this Section, the following definitions apply: (1) \"working time\" means: (a) in the case of mobile workers: the time from the beginning to the end of work, during which the mobile worker is at his or her workstation, at the disposal of the employer and exercising his or her functions or activities, that is to say: \u2014 the time devoted to all road transport activities, in particular, the following: (i) driving; (ii) loading and unloading; (iii) assisting passengers boarding and disembarking from the vehicle; (iv) cleaning and technical maintenance; and (v) all other work intended to ensure the safety of the vehicle and its cargo or to fulfil the legal or regulatory obligations directly linked to the specific transport operation under way, including monitoring of loading and unloading, administrative formalities with police, customs, immigration officers etc., \u2014 the times during which driver cannot dispose freely of his or her time and is required to be at his or her workstation, ready to take up normal work, with certain tasks associated with being on duty, in particular during periods awaiting loading or unloading where their foreseeable duration is not known in advance, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Parties; (b) in the case of self-employed drivers, the same definition applies to the time from the beginning to the end of work, during which the self-employed driver is at his or her workstation, at the disposal of the client and exercising his or her functions or activities other than general administrative work that is not directly linked to the specific transport operation under way. The break times referred to in Article 4, the rest times referred to in Article 5 and, without prejudice to the legislation of the Parties or agreements between the social partners providing that such periods should be compensated or limited, the periods of availability referred to in point (2) of this Article, shall be excluded from working time; (2) \"periods of availability\" means: \u2014 periods other than those relating to break times and rest times during which the mobile worker is not required to remain at his or her workstation, but must be available to answer any calls to start or resume driving or to carry out other work. In particular such periods of availability shall include periods during which the mobile worker is accompanying a vehicle being transported by ferryboat or by train as well as periods of waiting at frontiers and those due to traffic prohibitions. \u2014 Those periods and their foreseeable duration shall be known in advance by the mobile worker, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Parties, \u2014 for mobile workers driving in a team, the time spent sitting next to the driver or on the couchette while the vehicle is in motion; (3) \"workstation\" means: \u2014 the location of the main place of business of the road haulage operator for which the person performing mobile road transport activities carries out duties, together with its various subsidiary places of business, regardless of whether they are located in the same place as its head office or main place of business, \u2014 the vehicle which the person performing mobile road transport activities uses when that person carries out duties, and \u2014 any other place in which activities connected with transportation are carried out; (4) \"mobile worker\" means, for the purpose of this Section, any worker forming part of the travelling staff, including trainees and apprentices, who is in the service of an undertaking which operates transport services for passengers or goods by road on the territory of the other Party; (5) \"self-employed driver\" means anyone whose main occupation is to transport of goods by road for hire or reward, who is entitled to work for himself and who is not tied to an employer by an employment contract or by any other type of working hierarchical relationship, who is free to organise the relevant working activities, whose income depends directly on the profits made and who has the freedom to, individually or through a cooperation between self-employed drivers, have commercial relations with several customers. For the purposes of this Section, those drivers who do not satisfy those criteria shall be subject to the same obligations and benefit from the same rights as those provided for mobile workers by this Section; (6) \"person performing mobile road transport activities\" means any mobile worker or self-employed driver who performs such activities; (7) \"week\" means the period between 00.00 hours on Monday and 24.00 hours on Sunday; (8) \"night time\" means a period of at least four hours, as defined by national law, between 00.00 hours and 07.00 hours; and (9) \"night work\" means any work performed during night time. Article 3 Maximum weekly working time 1. Each Party shall take the measures necessary to ensure that the average weekly working time may not exceed 48 hours. The maximum weekly working time may be extended to 60 hours only if, over four months, an average of 48 hours a week is not exceeded. 2. Each Party shall take the measures necessary to ensure that working time for different employers is the sum of the working hours. The employer shall ask the mobile worker concerned in writing for an account of time worked for another employer. The mobile worker shall provide such information in writing. Article 4 Breaks Each Party shall take the measures necessary to ensure that, without prejudice to the provisions of Section 2 of Part B of this Annex, persons performing mobile road transport activities, in no circumstances work for more than six consecutive hours without a break. Working time shall be interrupted by a break of at least 30 minutes, if working hours total between six and nine hours, and of at least 45 minutes, if working hours total more than nine hours. Breaks may be subdivided into periods of at least 15 minutes each. Article 5 Rest periods For the purposes of this Section, apprentices and trainees who are in the service of an undertaking which operates transport services for passengers or goods by road journeys on the territory of the other Party shall be covered by the same provisions on rest time as other mobile workers pursuant to Section 2 of Part B of this Annex. Article 6 Night work Each Party shall take the measures necessary to ensure that: (a) if night work is performed, the daily working time does not exceed ten hours in each 24 period, and (b) compensation for night work is given in accordance with national legislative measures, collective agreements, agreements between the two sides of industry and/or national practice, on condition that such compensation is not liable to endanger road safety. Article 7 Derogations 1. Derogations from Articles 3 and 6 may, for objective or technical reasons or reasons concerning the organisation of work, be adopted by means of collective agreements, agreements between the social partners, or if that is not possible, by laws, regulations or administrative provisions provided that there is consultation of the representatives of the employers and workers concerned and efforts are made to encourage all relevant forms of social dialogue. 2. The option to derogate from Article 3 may not result in the establishment of a reference period exceeding six months, for calculation of the average maximum weekly working time of forty-eight hours. 3. The Specialised Committee on Road Transport shall be informed of the derogations applied by a Party in accordance with paragraph 1. Article 8 Information and records Each Party shall ensure that: (a) mobile workers are informed of the relevant national requirements, the internal rules of the road haulage operator and agreements between the two sides of industry, in particular collective agreements and any company agreements, reached on the basis of this Section; and (b) the working time of persons performing mobile road transport activities is recorded. Records shall be kept for at least two years after the end of the period covered. Employers shall be responsible for recording the working time of mobile workers. Employers shall upon request provide mobile workers with copies of the records of hours worked. Article 9 More favourable provisions This Section shall not affect the right of each Party to apply or introduce laws, regulations or administrative provisions more favourable to the protection of the health and safety of persons performing mobile road transport activities, or their right to facilitate or permit the application of collective agreements or other agreements concluded between the two sides of industry which are more favourable to the protection of the health and safety of mobile workers. Those rules shall be applied in a non-discriminatory manner. SECTION 4 USE OF TACHOGRAPHS BY DRIVERS Article 1 Subject matter and principles This Section lays down requirements for drivers falling within the scope of Section 2 of Part B regarding the use of tachographs referred to in point (b) of Article 465(1) of this Agreement. Article 2 Definitions 1. For the purposes of this Section, the definitions set out in Article 2 of Section 2 of Part B apply. 2. In addition to the definitions referred to in paragraph 1, for the purposes of this Section the following definitions apply: (a) \"tachograph\" or \"recording equipment\" means the equipment intended for installation in road vehicles to display, record, print, store and output automatically or semi-automatically details of the movement, including the speed, of such vehicles and details of certain periods of activity of their drivers; (b) \"record sheet\" means a sheet designed to accept and retain recorded data, to be placed in an analogue tachograph, and on which the marking devices of the analogue tachograph continuously inscribe the information to be recorded; (c) \"tachograph card\" means a smart card, intended for use with the tachograph, which allows identification by the tachograph of the role of the cardholder and allows data transfer and storage; (d) \"driver card\" means a tachograph card, issued by the competent authorities in a Party to a particular driver, which identifies the driver and allows for the storage of driver activity data; (e) \"analogue tachograph\" means a tachograph complying with the specifications in Annex I to Regulation (EU) No 165/2014 of the European Parliament and of the Council (3), as adapted by Appendix 31-B-4-1; (f) \"digital tachograph\" means a tachograph complying with one of the following set of specifications, as adapted by Appendix 31-B-4-2: \u2014 Annex IB to Regulation (EEC) No 3821/85 applicable until 30 September 2011; \u2014 Annex IB to Regulation (EEC) No 3821/85 applicable from 1 October 2011; or \u2014 Annex IB to Regulation (EEC) No 3821/85 applicable from 1 October 2012; (g) \"smart tachograph 1\" means a tachograph complying with Annex IC to Commission Implementing Regulation (EU) 2016/799 (4) applicable from 15 June 2019, as adapted by Appendix 31-B-4-3; (h) \"smart tachograph 2\" means a tachograph complying with the following requirements: \u2014 automatic recording of the border crossing; \u2014 recording of loading and unloading activities; \u2014 recording whether the vehicle is used for carriage of goods or passengers; and \u2014 with the specifications to be set out in the implementing acts referred to in the first paragraph of Article 11 of Regulation (EU) No 165/2014 of the European Parliament and of the Council (5), as adapted by a decision of the Specialised Committee on Road Transport; (i) \"event\" means an abnormal operation detected by the digital tachograph which may result from a fraud attempt; (j) \"non-valid card\" means a card detected as faulty, or whose initial authentication failed, or whose start of validity date is not yet reached, or whose expiry date has passed. Article 3 Use of driver cards 1. The driver card is personal. 2. A driver may hold no more than one valid driver card, and is only authorised to use his or her own personalised driver card. A driver shall not use a driver card which is defective or which has expired. Article 4 Issuing of driver cards 1. Driver cards shall be requested to the competent authority in the Party where the driver has his or her normal residence. 2. For the purposes of this Article, \"normal residence\" means the place where a person usually lives, that is for at least 185 days in each calendar year, because of personal and occupational ties, or, in the case of a person with no occupational ties, because of personal ties which show close links between that person and the place where that person is living. However, the normal residence of a person whose occupational ties are in a place different from their personal ties and who consequently lives in turn in different places situated in the two Parties shall be regarded as being the place of their personal ties, provided that such person returns there regularly. This last condition does not need to be complied with where the person is living in a Party in order to carry out a fixed-term assignment. 3. Drivers shall give proof of their normal residence by any appropriate means, such as their identity card or any other valid document. Article 5 Renewal of driver cards Where a driver wishes to renew his or her driver card, the driver shall apply to the competent authorities in the Party of his or her normal residence not later than 15 working days before the expiry date of the card. Article 6 Use of driver cards and record sheets 1. Drivers shall use record sheets or driver cards every day on which they drive, starting from the moment they take over the vehicle. The record sheet or driver card shall not be withdrawn before the end of the daily working period unless its withdrawal is otherwise authorised or is necessary in order to enter the symbol of the country after having crossed a border. No record sheet or driver card may be used to cover a period longer than that for which it is intended. 2. Drivers shall adequately protect the record sheets or driver cards, and shall not use dirty or damaged record sheets or driver cards. The driver shall ensure that, taking into account the length of the period of service, the printing of data from the tachograph at the request of a control officer can be carried out correctly in the event of an inspection. 3. When, as a result of being away from the vehicle, a driver is unable to use the tachograph fitted to the vehicle, the periods of time referred to in points (b)(ii), (b)(iii) and (b)(iv) of paragraph 5 shall: (a) if the vehicle is fitted with an analogue tachograph, be entered on the record sheet, either manually, by automatic recording or other means, legibly and without dirtying the record sheet; or (b) if the vehicle is fitted with a digital, smart 1 or smart 2 tachograph, be entered onto the driver card using the manual entry facility provided for in the tachograph. Each Party shall not impose on drivers a requirement to present forms attesting to their activities while away from the vehicle. 4. Where there is more than one driver on board a vehicle fitted with a digital, a smart 1 or smart 2 tachograph, each driver shall ensure that his or her driver card is inserted into the correct slot in the tachograph. Where there is more than one driver on board a vehicle fitted with an analogue tachograph, the drivers shall amend the record sheets as necessary, so that the relevant information is recorded on the record sheet of the driver who is actually driving. 5. Drivers shall: (a) ensure that the time recorded on the record sheet corresponds to the official time in the country of registration of the vehicle; (b) operate the switch mechanisms enabling the following periods of time to be recorded separately and distinctly: (i) under the sign: driving time, (ii) under the sign: \"other work\", which means any activity other than driving, as defined in point (a) of Article 2 of Section 3 of Part B, and also any work for the same or another employer within or outside of the transport sector, (iii) under the sign: \"availability\", as defined in point (b) of Article 2 of Section 3 of Part B, (iv) under the sign: breaks, rest, annual leave or sick leave, and (v) under the sign for \"ferry/train\": In addition to the sign: the rest period spent on a ferry or train as required in paragraph 12 of Article 6 of Section 2 of Part B. 6. Each driver of a vehicle fitted with an analogue tachograph shall enter the following information on his or her record sheet: (a) on beginning to use the record sheet \u2014 the driver's surname and first name; (b) the date and place where use of the record sheet begins and the date and place where such use ends; (c) the registration number of each vehicle to which the driver is assigned, both at the start of the first journey recorded on the record sheet and then, in the event of a change of vehicle, during use of the record sheet; (d) the odometer reading: (i) at the start of the first journey recorded on the record sheet, (ii) at the end of the last journey recorded on the record sheet, (iii) in the event of a change of vehicle during a working day, the reading on the first vehicle to which the driver was assigned and the reading on the next vehicle; (e) the time of any change of vehicle; and (f) the symbols of the countries in which the daily working period started and finished. The driver shall also enter the symbol of the country that the driver enters after crossing a border of an EU Member State and of the United Kingdom at the beginning of the driver's first stop in that Member State or the United Kingdom. That first stop shall be made at the nearest possible stopping place at or after the border. Where the crossing of the border takes place on a ferry or train, the driver shall enter the symbol of the country at the port or station of arrival. 7. The driver shall enter in the digital tachograph the symbols of the countries in which the daily working period started and finished. From 2 February 2022, the driver shall also enter the symbol of the country that the driver enters after crossing a border of a Member State and of the United Kingdom at the beginning of the driver's first stop in that Member State or the United Kingdom. That first stop shall be made at the nearest possible stopping place at or after the border. Where the crossing of the border takes place on a ferry or train, the driver shall enter the symbol of the country at the port or station of arrival. A Member State or the United Kingdom may require drivers of vehicles engaged in transport operations inside their territory to add more detailed geographic specifications to the country symbol, provided that each Party notifies in advance the other Party about those detailed geographic specifications. It shall not be necessary for drivers to enter the information referred to in the first sentence of the first subparagraph if the tachograph is automatically recording that location data. Article 7 Correct use of tachographs 1. Transport undertakings and drivers shall ensure the correct functioning and proper use of digital tachographs and driver cards. Transport undertakings and drivers using analogue tachographs shall ensure their correct functioning and the proper use of record sheets. 2. It shall be forbidden to falsify, conceal, suppress or destroy data recorded on the record sheet or stored in the tachograph or on the driver card, or print-outs from the tachograph. Any manipulation of the tachograph, record sheet or driver card which could result in data and/or printed information being falsified, suppressed or destroyed shall also be prohibited. No device which could be used to that effect shall be present on the vehicle. Article 8 Stolen, lost or defective driver cards 1. Issuing authorities of the Parties shall keep records of issued, stolen, lost or defective driver cards for a period at least equivalent to their period of validity. 2. If a driver card is damaged or if it malfunctions, the driver shall return it to the competent authority in the country of the driver's normal residence. Theft of the driver card shall be formally declared to the competent authorities of the State where the theft occurred. 3. Any loss of the driver card shall be reported in a formal declaration to the competent authorities in the issuing Party and to the competent authorities in the Party of the driver's normal residence if that is different. 4. If the driver card is damaged, malfunctions or is lost or stolen, the driver shall, within seven days, apply for its replacement to the competent authorities in the Party of the driver's normal residence. 5. In the circumstances set out in paragraph 4, the driver may continue to drive without a driver card for a maximum period of 15 days or for a longer period if that is necessary for the vehicle to return to the premises where it is based, provided that the driver can prove the impossibility of producing or using the card during that period. Article 9 Damaged driver cards and record sheets 1. In the event of damage to a record sheet bearing recordings or to a driver card, drivers shall keep the damaged record sheet or driver card together with any spare record sheet used to replace it. 2. Where a driver card is damaged, malfunctions, or is lost or stolen, the driver shall: (a) at the start of his or her journey, print out the details of the vehicle that the driver is driving, and enter on that printout: (i) details that enable the driver to be identified (name, driver card or driving licence number), including the driver's signature; and (ii) the periods referred to in points (b)(ii), (b)(iii) and (b)(iv) of Article 6(5); (b) at the end of the journey, print out the information relating to periods of time recorded by the tachograph, record any periods of other work, availability and rest taken since the printout made at the start of the journey, where not recorded by the tachograph, and mark on that document details enabling the driver to be identified (name, driver card or driving licence number), including the driver's signature. Article 10 Records to be carried by the driver 1. Where a driver drives a vehicle fitted with an analogue tachograph, the driver shall be able to produce, whenever an authorised control officer so requests: (i) the record sheets for the current day and the preceding 28 days; (ii) the driver card, if one is held; and (iii) any manual records and printouts made during the current day and the previous 28 days. 2. Where the driver drives a vehicle fitted with a digital, a smart 1 or smart 2 tachograph, the driver shall be able to produce, whenever an authorised control officer so requests: (i) the driver's driver card; (ii) any manual records and printouts made during the current day and the previous 28 days; and (iii) the record sheets corresponding to the same period as that referred to in point (ii) during which the driver drove a vehicle fitted with an analogue tachograph. From 31 December 2024, the period of 28 days referred to in points (i) and (iii) of paragraph 1 and in point (ii) of paragraph 2 shall be replaced by 56 days. 3. An authorised control officer may check compliance with Section 2 of Part B by analysis of the record sheets, of the displayed, printed or downloaded data which have been recorded by the tachograph or by the driver card or, failing that, of any other supporting document that justifies non-compliance with a provision of that Section. Article 11 Procedures for drivers in the event of malfunctioning equipment While the tachograph is unserviceable or malfunctioning, the driver shall mark data enabling him to be identified (name, driver card or driving licence number), including a signature, as well as the information for the various periods of time which are no longer recorded or printed out correctly by the tachograph: (a) on the record sheet or sheets; or (b) on a temporary sheet to be attached to the record sheet or to be kept together with the driver card. Article 12 Enforcement measures 1. Each Party shall adopt all appropriate measures to ensure observance of the provisions of Sections 2, 3 and 4 of Part B, in particular by ensuring annually an adequate level of roadside checks and checks performed at the premises of undertakings covering a large and representative cross-section of mobile workers, drivers, undertakings and vehicles of all transport categories falling within the scope of those Sections. The competent authorities in each Party shall organise the checks so that: (i) during each calendar year, a minimum of 3 % of the days worked by the drivers of vehicles falling within the scope of Section 2 of Part B applies shall be checked; and (ii) at least 30 % of the total number of working days checked shall be checked at the roadside and at least 50 % at the premises of undertakings. The elements of roadside checks shall include: (i) daily and weekly driving periods, interruptions and daily and weekly rest periods; (ii) the record sheets of the preceding days, which shall be on board the vehicle, and/or the data stored for the same period on the driver card and/or in the memory of the tachograph and/or on the printouts, when required; and (iii) the correct functioning of the tachograph. Those checks shall be carried out without discrimination among vehicles, undertakings and drivers whether resident or not, and regardless of the origin or destination of the journey or type of tachograph. The elements of checks on the premises of undertakings shall include, in addition to the elements subject to roadside checks: (i) weekly rest periods and driving periods between those rest periods; (ii) fortnightly driving limits; (iii) compensation for reduced weekly rest periods in accordance with Article 6(6) and (7) of Section 2 of Part B; and (iv) use of record sheets and/or vehicle unit and driver card data and printouts and/or the organisation of drivers' working time. 2. If the findings of a roadside check on the driver of a vehicle registered in the territory of the other Party provide grounds to believe that infringements have been committed which cannot be detected during the check due to lack of necessary data, the competent authorities in each Party shall assist each other to clarify the situation. In cases where, to that end, the competent authorities in a Party carry out a check at the premises of the undertaking, the results of that check shall be communicated to the competent authorities of the other Party. 3. The competent authorities in the Parties shall work in cooperation with each other in the organisation of concerted roadside checks. 4. Each Party shall introduce a risk rating system for undertakings based on the relative number and severity of any infringements, as set out in Appendix 31-A-1-1 and of any infringements included in the list drawn up by the Specialised Committee on Road Transport under Article 6(3) of Section 1 of Part A, that an individual undertaking has committed. 5. Undertakings with a high risk rating shall be checked more closely and more often. 6. Each Party and, in the case of the Union, each Member State, shall enable its competent authorities to impose a penalty on a road haulage operator and/or a driver for an infringement of the applicable provisions on driving time, breaks and rest periods detected on its territory and for which a penalty has not already been imposed, even where that infringement has been committed on the territory of the other Party or, in the case of the Union, the territory of a Member State or of a third country. Appendix 31-B-4-1 ADAPTATIONS TO THE TECHNICAL SPECIFICATIONS OF THE ANALOGUE TACHOGRAPH Annex I to Regulation (EU) No 165/2014 is adapted for the purpose of this Section as follows: (a) In Section III (Construction requirements for recording equipment), in paragraph 4.1 of subsection (c) (Recording instruments), for \"points (ii), (iii) and (iv) of Article 34(5)(b) of this Regulation\" substitute \"points (ii), (iii) and (iv) of point (b) of Article 6(5) of Section 4 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part.\" (b) In Section III (Construction requirements for recording equipment), in paragraph 4.2 of subsection (c) (Recording instruments), for \"Article 34 of this Regulation\" substitute \"Article 6(5) of Section 4 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part.\" (c) In Section IV (Record sheets), in the third subparagraph of paragraph 1 of subsection (a) (General points), for \"Article 34 of this Regulation\" substitute \"Article 6(6) of Section 4 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part. (d) In Section V (Installation of recording equipment), in the first subparagraph of paragraph 5, for \"this Regulation\" substitute \"Section 4 of Part B and Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\". (e) In Section V (Installation of recording equipment), in the third subparagraph of paragraph 5, for \"Part A of Annex II to Directive 2007/46/EC of the European Parliament and of the Council\" substitute \"the Consolidated Resolution on the Construction of Vehicles (R.E.3)\" and for \"this Regulation\" substitute \"Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\". (f) In Section VI (Checks and inspections), in the text before paragraph 1, after \"Member States\" insert \"and the United Kingdom\". (g) In Section VI (Checks and inspections), in the second subparagraph of paragraph 1 (Certification of new or repaired instruments), after \"Member States\" insert \"and the United Kingdom\", and for \"this Regulation\" substitute \"Section 4 of Part B and Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\". (h) In Section VI (Checks and inspections), in subparagraph (b) of paragraph 3 (Periodic inspections), after \"Member State\" insert \"and the United Kingdom\". Appendix 31-B-4-2 ADAPTATIONS TO THE TECHNICAL SPECIFICATIONS OF THE DIGITAL TACHOGRAPH Annex IB to Regulation (EEC) No 3821/85, including the appendixes introduced by Council Regulation (EC) No 2135/98 (6), is adapted for the purpose of this Section as follows: 1. In the case of the United Kingdom, the references to \"Member State\" are replaced by \"Party\", except for the references in subsection IV (Construction and functional requirements for tachograph cards), paragraph 174 and subsection VII (Card issuing), paragraph 268a; 2. For \"Council Regulation (EEC) No 3820/85\" and \"Regulation (EC) No 561/2006\" substitute \"Section 2 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\"; Section I (Definitions) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 3. Point (u) is replaced by the following: \"(u) 'effective circumference of the wheels' means the average of the distances travelled by each of the wheels moving the vehicle (driving wheels) in the course of one complete rotation. The measurement of those distances shall be made under standard test conditions as defined under requirement 414 and is expressed in the form 'l = \u2026 mm'. Vehicle manufacturers may replace the measurement of those distances by a theoretical calculation which takes into account the distribution of the weight on the axles, vehicle unladen in normal running order, namely with coolant fluid, lubricants, fuel, tools, spare-wheel and driver. The methods for such theoretical calculation are subject to approval by the competent authority in a Party and can take place only before tachograph activation;\" 4. In point (bb), the reference to \"Council Directive 92/6/EEC\" is replaced by \"the applicable law of each Party\". 5. Point (ii) is replaced by the following: \"'security certification' means: process to certify, by a Common Criteria certification body, that the recording equipment (or component) or the tachograph card under investigation fulfils the security requirements defined in Appendix 10 (Generic security targets);\" 6. In point (mm), the reference to \"Directive 92/23/EEC\" is replaced by \"UNECE Regulation No 54\". 7. In point (nn), footnote 17 is replaced by the following: \"'Vehicle Identification Number' means a fixed combination of characters assigned to each vehicle by the manufacturer, which consists of two sections: the first, composed of not more than six characters (letters or figures), identifying the general characteristics of the vehicle, in particular the type and model; the second, composed of eight characters of which the first four may be letters or figures and the other four figures only, providing, in conjunction with the first section, clear identification of a particular vehicle.\" 8. In point (rr), the first indent is replaced by the following: \"\u2013 installed and used only in M1 and N1 type vehicles as defined in the Consolidated Resolution on the Construction of Vehicles (R.E.3)\", Section II (General characteristics and functions of the recording equipment) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 9. In paragraph 004, the last subparagraph is deleted. Section III (Construction and functional requirements for recording equipment) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 10. In paragraph 065, the reference to \"Directive 2007/46/EC\" is replaced by \"the Consolidated Resolution on the Construction of Vehicles (R.E.3).\" 11. In paragraph 162, the reference to \"Commission Directive 95/54/EC of 31 October 1995 adapting to technical progress Council Directive 72/245/EEC\" is replaced by \"UNECE Regulation No 10\". Section IV (Construction and functional requirements for tachograph cards) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 12. In paragraph 174, the reference to \"UK: The United Kingdom\" is replaced by \"For the United Kingdom, the distinguishing sign shall be the UK.\" 13. In paragraph 185, the reference to \"Community territory\" is replaced by \"the territory of the Union and of the United Kingdom\". 14. In paragraph 188, the reference to \"Commission Directive 95/54/EC of 31 October 1995\" is replaced by \"UNECE Regulation No 10\". 15. In paragraph 189, the last subparagraph is deleted. Section V (Installation of recording equipment) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 16. In paragraph 250a, the reference to \"Regulation (EC) No 68/2009\" is replaced by \"Appendix 12 of this Annex.\" Section VI (Checks, inspections and repairs) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 17. The introductory sentence is replaced by the following: \"Requirements on the circumstances in which seals may be removed, as referred to in Article 5(5) of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, are defined in Chapter V(3) of this Annex\" 18. Under subsection 1 (Approval of fitters or workshops), the reference to \"Article 12(1) of this Regulation\" is replaced by \"Articles 5(1) and 8 of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\". Section VII (Card issuing) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 19. In paragraph 268a, after \"Member States\", wherever it occurs, insert \"and the United Kingdom\". Section VIII (Type approval of recording equipment and tachograph cards) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 20. In paragraph 271, omit \"in accordance with Article 5 of this Regulation\". Appendix 1 (Data dictionary) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 21. In point 2.111, the reference to \"Directive 92/23 (EEC) 31.3.1992, OJ L 129, p. 95\" is replaced by \"UNECE Regulation No 54\". Appendix 9 (Type approval List of minimum required tests) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 22. In subpoint 5.1 of Section 2 (Vehicle unit functional tests), the reference to \"Directive 95/54/EC\" is replaced by \"UNECE Regulation No 10\". 23. In subpoint 5.1 of Section 3 (Motion sensor functional tests), the reference to \"Directive 95/54/EC\" is replaced by \"UNECE Regulation No 10\". Appendix 12 (Adaptor for M1 and N1 category vehicles) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 24. In Section 4 (Construction and functional requirements for the adaptor) in paragraph 4.5 (performance characteristics) in ADA_023, for \"Commission Directive 2006/28/EC adapting to technical progress Council Directive 72/245/EEC\" substitute \"UNECE Regulation No 10\". 25. In point 5.1 of the table under subsection 7.2 (Functional certificate), for \"Directive 2006/28/EC\" substitute \"UNECE Regulation No 10\". Appendix 31-B-4-3 ADAPTATIONS TO THE TECHNICAL SPECIFICATIONS OF THE SMART TACHOGRAPH Commission Implementing Regulation (EU) 2016/799, including its annexes and appendixes, is adapted for the purpose of this Section as follows: 1. In the case of the United Kingdom, the references to \"Member State\" are replaced by \"Party\", except for the references in point (229) of subsection 4.1 and in point (424) of Section 7; 2. For \"Regulation (EEC) No 3820/85\" and \"Regulation (EC) No 561/2006\" substitute \"Section 2 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\"; 3. For \"Regulation (EU) No 165/2014\" substitute \"Section 4 of Part B and Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, except for the references in point (402) of subsection 5.3 and in point (424) of Section 7\"; 4. For \"Directive (EU) 2015/719\" and for \"Council Directive 96/53/EC\" substitute \"Section 1 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\". Section 1 (Definitions) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 5. Point (u) is replaced by the following: \"(u) 'effective circumference of the wheels' means: the average of the distances travelled by each of the wheels moving the vehicle (driving wheels) in the course of one complete rotation. The measurement of those distances shall be made under standard test conditions as defined under requirement 414 and is expressed in the form 'l = \u2026 mm'. Vehicle manufacturers may replace the measurement of those distances by a theoretical calculation which takes into account the distribution of the weight on the axles, vehicle unladen in normal running order, namely with coolant fluid, lubricants, fuel, tools, spare-wheel and driver. The methods for such theoretical calculation are subject to approval by the competent authority in a Party and can take place only before tachograph activation;\"; 6. In point (hh), the reference to \"Council Directive 92/6/EEC\" is replaced by \"the applicable law of each Party\"; 7. In point (uu), the reference to \"Directive 92/23/EEC\" is replaced by \"UNECE Regulation No 54\"; 8. In point (vv), footnote 9 is replaced by the following: \"'Vehicle Identification Number' means a fixed combination of characters assigned to each vehicle by the manufacturer, which consists of two sections: the first, composed of not more than six characters (letters or figures), identifying the general characteristics of the vehicle, in particular the type and model; the second, composed of eight characters of which the first four may be letters or figures and the other four figures only, providing, in conjunction with the first section, clear identification of a particular vehicle.\"; 9. In point (yy), the first indent is replaced by the following: \"\u2013 installed and used only in M1 and N1 type vehicles as defined in the Consolidated Resolution on the Construction of Vehicles (R.E.3);\"; 10. Point (aaa) is deleted; 11. In point (ccc), the first paragraph is replaced by \"15 June 2019\". Section 2 (General characteristics and functions of the recording equipment) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 12. The last subparagraph of paragraph (7) of subsection 2.1 is deleted. Section 3 (Construction and functional requirements for recording equipment) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 13. In point (200) of subsection 3.20, the second sentence of the third subparagraph is deleted. 14. Point (201) of subsection 3.20 is replaced by the following: \"The vehicle unit may also be able to output the following data using an appropriate dedicated serial link independent from an optional CAN bus connection (ISO 11898 Road vehicles \u2014 Interchange of digital information \u2014 Controller Area Network (CAN) for high speed communication), to allow their processing by other electronic units installed in the vehicle: \u2014 current UTC date and time, \u2014 speed of the vehicle, \u2014 total distance travelled by the vehicle (odometer), \u2014 currently selected driver and co-driver activity, \u2014 information if any tachograph card is currently inserted in the driver slot and in the co-driver slot and (if applicable) information about the corresponding cards identification (card number and issuing country). Other data may also be output in addition to that minimum list. When the ignition of the vehicle is ON, those data shall be permanently broadcast. When the ignition of the vehicle is OFF, at least any change of driver or co-driver activity and/or any insertion or withdrawal of a tachograph card shall generate a corresponding data output. In the event that data output has been withheld whilst the ignition of the vehicle is OFF, that data shall be made available once the ignition of the vehicle is ON again. The driver consent shall be required in case personal data are transmitted.\" Section 4 (Construction and functional requirements for tachograph cards) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 15. In Point (229) of the subsection 4.1, the following subparagraph is added: \"For the United Kingdom, the distinguishing sign shall be the UK.\"; 16. In point (237), for \"Article 26.4 of Regulation (EU) No. 165/2014\" substitute \"Article 9(2) of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\"; 17. In point (241) of subsection 4.4 of Chapter 4 of this Annex, the word \"Community territory\" is replaced by \"the territory of the Union and of the United Kingdom\"; 18. Point (246) in subsection 4.5 is deleted. Section 5 (Installation of recording equipment) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 19. The first paragraph of point (397) in subsection 5.2 is replaced by the following: \"(397) For M1 and N1 vehicles only, and which are fitted with an adaptor in conformity with Appendix 16 of this Annex and where it is not possible to include all the information necessary, as described in Requirement 396, a second, additional, plaque may be used. In such cases, this additional plaque shall contain at least the last four indents described in Requirement 396.\"; 20. In point (402) of subsection 5.3, for \"Article 22(3) of Regulation (EU) No 165/2014\" substitute \"Article 5(3) of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part.\". Section 6 (Checks, inspections and repairs) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 21. The introductory sentence is replaced by the following: \"Requirements on the circumstances in which seals may be removed are defined in Chapter 5.3 of this Annex.\"; Section 7 (Card issuing) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 22. In point (424), after the reference to \"Member States\" insert \"and the United Kingdom\", and for the reference to \"Article 31 of Regulation (EU) No 165/2014\" substitute \"Article 13 of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\". Appendix 1 (Data dictionary) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 23. In point 2.163, for \"Directive 92/23/EEC\" substitute \"UNECE Regulation No 54\". Appendix 11 (Common security mechanisms) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 24. In point 9.1.4 (Equipment Level: Vehicle Units), in the first note below CSM_78, for \"Regulation (EU) No 581/2010\" substitute \"Article 7(5) of Section 2 of Part B Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\". 25. In point 9.1.5 (Equipment level: Tachograph Cards), in the note below CSM_89, for \"Regulation (EU) No 581/2010\" substitute \"Article 7(5) of Section 2 of Part B Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part\". Appendix 12 (Positioning based on Global Navigation Satellite System (GNSS)) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 26. The second subparagraph of Section 1 (Introduction) is deleted. 27. In Section 2 (Specification of the GNSS receiver), the reference to \"compatibility with the services provided by the Galileo and European Geostationary Navigation Overlay Service (EGNOS) programmes as set out in Regulation (EU) No 1285/2013 of the European Parliament and of the Council\", is replaced by \"compatibility with Satellite Based Augmentation Systems (SBAS)\". Appendix 16 (Adaptor for M1 and N1 category vehicles) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 28. In point 5.1 in the table under Section (7) (Type approval of recording equipment when an adaptor is used), the reference to \"Directive 2006/28/EC\" is replaced by \"UNECE Regulation No 10\". PART C REQUIREMENTS FOR VEHICLES USED FOR THE TRANSPORT OF GOODS IN ACCORDANCE WITH ARTICLE 466 OF THIS AGREEMENT SECTION 1 WEIGHTS AND DIMENSIONS Article 1 Subject matter and principles The maximum weights and dimensions of the vehicles that may be used for journeys referred to in Article 462 of this Agreement are those set out in Appendix 31-C-1-1. Article 2 Definitions For the purposes of this Section, the following definitions apply: (a) \"motor vehicle\" means any power-driven vehicle which travels on the road by its own means; (b) \"trailer\" means any vehicle intended to be coupled to a motor vehicle excluding semitrailers, and constructed and equipped for the carriage of goods; (c) \"semi-trailer\" means any vehicle intended to be coupled to a motor vehicle in such a way that part of it rests on the motor vehicle with a substantial part of its weight and of the weight of its load being borne by the motor vehicle, and constructed and equipped for the carriage of goods; (d) \"vehicle combination\" means either: \u2014 a road train consisting of a motor vehicle coupled to a trailer; or \u2014 an articulated vehicle consisting of a motor vehicle coupled to a semi-trailer; (e) \"conditioned vehicle\" means any vehicle whose fixed or movable superstructures are specially equipped for the carriage of goods at controlled temperatures and whose side walls, inclusive of insulation, are each at least 45 mm thick; (f) \"maximum authorised dimensions\" means the maximum dimensions for use of a vehicle; (g) \"maximum authorised weight\" means the maximum weight for use of a laden vehicle; (h) \"maximum authorised axle weight\" means the maximum weight for use of a laden axle or group of axles; (i) \"tonne\" means the weight executed by the mass of a tonne and shall correspond to 9.8 kilonewtons (kN); (j) \"indivisible load\" means a load that cannot, for the purpose of carriage by road, be divided into two or more loads without undue expense or risk of damage and which owing to its dimensions or mass cannot be carried by a motor vehicle, trailer, road train or articulated vehicle complying with this Section in all respects; (k) \"alternative fuels\" means fuels or power sources which serve, at least partly, as a substitute for fossil oil sources in the energy supply to transport and which have the potential to contribute to its decarbonisation and enhance the environmental performance of the transport sector, consisting of: (i) electricity consumed in all types of electric vehicles; (ii) hydrogen; (iii) natural gas, including biomethane, in gaseous form (Compressed Natural Gas \u2014 CNG) and liquefied form (Liquefied Natural Gas \u2014 LNG); (iv) Liquefied Petroleum Gas (LPG); (v) mechanical energy from on-board storage/on-board sources, including waste heat, (l) \"alternatively fuelled vehicle\" means a motor vehicle powered wholly or in part by an alternative fuel; (m) \"zero-emission vehicle\" means a heavy goods vehicle without an internal combustion engine, or with an internal combustion engine that emits less than 1 g CO2/kWh; and (n) \"intermodal transport operation\" means the transport of one or more containers or swap bodies, with a length of no more than 45 feet, where the lorry, trailer, semi-trailer (with or without tractor unit), swap body or container uses the road on the initial and/or final leg of the journey and, on the other leg, rail or inland waterway or maritime services. Article 3 Special permits A vehicle or vehicle combination which exceeds the maximum weights or dimensions set out in Appendix 31-C-1-1 may only be allowed to circulate on the basis of a special permit issued without discrimination by the competent authorities, or on the basis of similar non-discriminatory arrangements agreed on a case-by-case basis with those authorities, where these vehicles or vehicle combinations carry or are intended to carry indivisible loads. Article 4 Local restrictions This Section shall not preclude the non-discriminatory application of road traffic provisions in force in each Party which permit the weight and/or dimensions of vehicles on certain roads or civil engineering structures to be limited. This includes the possibility to impose local restrictions on maximum authorised dimensions and/or weights of vehicles that may be used in specified areas or on specified roads, where the infrastructure is not suitable for long and heavy vehicles, such as city centres, small villages or places of special natural interest. Article 5 Aerodynamic devices attached to the rear of vehicles or vehicle combinations 1. Vehicles or vehicle combinations equipped with aerodynamic devices may exceed the maximum lengths provided for in point 1.1 of Appendix 31-C-1-1, to allow the addition of such devices to the rear of vehicles or vehicle combinations. Vehicles or vehicle combinations equipped with such devices shall comply with point 1.5 of Appendix 31-C-1-1, and any exceeding of the maximum lengths shall not result in an increase in the loading length of those vehicles or vehicle combinations. 2. The aerodynamic devices referred to in paragraph 1 shall fulfil the following operational conditions: (a) in circumstances where the safety of other road users or of the driver is at risk, they shall be folded, retracted or removed by the driver; (b) when aerodynamic devices and equipment exceed 500 mm in length in the in-use position they shall be retractable or foldable; (c) their use on urban and inter urban road infrastructures shall take into account the special characteristics of areas where the speed limit is less than or equal to 50 km/h and where vulnerable road users are more likely to be present; and (d) when retracted/folded, they shall not exceed the maximum authorised length by more than 20 cm. Article 6 Aerodynamic cabins Vehicles or vehicle combinations may exceed the maximum lengths laid down in point 1.1 of Appendix 31-C-1-1 provided that their cabs deliver improved aerodynamic performance, energy efficiency and safety performance. Vehicles or vehicle combinations equipped with such cabs shall comply with point 1.5 of Appendix 31-C-1-1 and any exceeding of the maximum lengths shall not result in an increase in the load capacity of those vehicles. Article 7 Intermodal transport operations 1. The maximum lengths laid down in point 1.1 of Appendix 31-C-1-1, subject where applicable to Article 6, and the maximum distance laid down in point 1.6 of Appendix 31-C-1-1, may be exceeded by 15 cm for vehicles or vehicle combinations engaged in the transport of 45-foot containers or 45-foot swap bodies, empty or loaded, provided that the road transport of the container or swap body in question is part of an intermodal transport operation carried out according to the conditions set by each Party. 2. For intermodal transport operations, the maximum authorised vehicle weight for articulate vehicles with five or six axles may be exceeded by two tonnes in the combination set out in point 2.2.2(a) of Appendix 31-C-1-1 and by four tonnes in the combination set out in point 2.2.2(b) of Appendix 31-C-1-1. The maximum authorised vehicle weight of these vehicles may not exceed 44 tonnes. Article 8 Proof of compliance 1. As proof of compliance with this Section, vehicles covered by it shall carry one of the following proofs: (a) a combination of the following two plates: \u2014 the manufacturer's statutory plate, which is a plate or label, affixed by the manufacturer on a vehicle that provides the main technical characteristics which are necessary for the identification of the vehicle and provides the competent authorities with the relevant information concerning the permissible maximum laden masses; and \u2014 a plate relating to dimensions as far as possible affixed next to the manufacturer's statutory plate and containing the following information: (i) name of the manufacturer; (ii) vehicle identification number; (iii) length of the motor vehicle, trailer or semi-trailer (L); (iv) width of the motor vehicle, trailer or semi-trailer (W); and (v) data for the measurement of the length of vehicle combinations: \u2014 the distance (a) between the front of the motor vehicle and the centre of the coupling device (coupling hook or fifth wheel); in the case of a fifth wheel with several coupling points, the minimum and maximum values must be given (amin and amax); \u2014 the distance (b) between the centre of the coupling device of the trailer (fifth wheel ring) or of the semi-trailer (king pin) and the rear of the trailer or of the semi-trailer; in the case of a device with several coupling points, the minimum and maximum values must be given (bmin and bmax); The length of vehicle combinations is the length of the motor vehicle and trailer or semi-trailer placed in a straight line behind each other. (b) a single plate containing the information on the two plates referred to in point (a); or (c) a single document issued by the competent authorities of a Party or, in the case of the Union, the Member State where the vehicle is registered or put into circulation containing the same information as the plates referred to in point (a). It shall be kept in a place easily accessible to inspection and shall be adequately protected. 2. If the characteristics of the vehicle no longer correspond to those indicated on the proof of compliance, the Party or, in the case of the Union, the Member State in which the vehicle is registered or put into circulation shall take the necessary steps to ensure that the proof of compliance is altered. 3. The plates and documents referred to in paragraph 1 shall be recognised by the Parties as the proof of vehicle compliance provided for in this Section. Article 9 Enforcement 1. Each Party shall take specific measures to identify vehicles or vehicle combinations in circulation that are likely to have exceeded the maximum authorised weight and that shall therefore be checked by the competent authorities of the Parties in order to ensure compliance with the requirements of this Section. This can be done with the aid of automatic systems set up on the road infrastructure, or by means of on-board weighing equipment installed in vehicles. Such on-board weighing equipment shall be accurate and reliable, fully interoperable and compatible with all vehicle types. 2. A Party shall not require on-board weighing equipment to be installed on vehicles or vehicle combinations which are registered in the other Party. 3. Where automatic systems are used to establish infringements of this Section and to impose penalties, such automatic systems shall be certified. Where automatic systems are used only for identification purposes, they need not be certified. 4. The Parties shall, in accordance with Article 14 of Section 1 of Part A, ensure that their competent authorities exchange information about infringements and penalties relating to this Article. Appendix 31-C-1-1 MAXIMUM WEIGHTS AND DIMENSIONS AND RELATED CHARACTERISTICS OF VEHICLES 1. Maximum authorised dimensions for vehicles (in metre; \"m\") 1.1 Maximum length: \u2014 motor vehicle 12.00 m \u2014 trailer 12.00 m \u2014 articulated vehicle 16.50 m \u2014 road train 18.75 m 1.2 Maximum width: (a) all vehicles except the vehicles referred to in point (b) 2.55 m (b) superstructures of conditioned vehicles or conditioned containers or swap bodies transported by vehicles 2.60 m 1.3 Maximum height (any vehicle) 4.00 m 1.4 Removable superstructures and standardised freight items such as containers are included in the dimensions specified in points 1.1, 1.2, 1.3, 1.6, 1.7, 1.8 and 4.4 1.5 Any motor vehicle or vehicle combination which is in motion must be able to turn within a swept circle having an outer radius of 12.50 m and an inner radius of 5.30 m 1.6 Maximum distance between the axis of the fifth-wheel king pin and the rear of a semi-trailer 12.00 m 1.7 Maximum distance measured parallel to the longitudinal axis of the road train from the foremost external point of the loading area behind the cabin to the rearmost external point of the trailer of the combination, minus the distance between the rear of the drawing vehicle and the front of the trailer 15.65 m 1.8 Maximum distance measured parallel to the longitudinal axis of the road train from the foremost external point of the loading area behind the cabin to the rearmost external point of the trailer of the combination 16.40 m 2. Maximum authorised vehicle weight (in tonnes) 2.1 Vehicles forming part of a vehicle combination 2.1.1 Two-axle trailer 18 tonnes 2.1.2 Three-axle trailer 24 tonnes 2.2 Vehicle combinations In the case of vehicle combinations including alternatively fuelled or zero-emission vehicles, the maximum authorised weights provided for in this Section are increased by the additional weight of the alternative fuel or zero-emission technology with a maximum of 1 tonne and 2 tonnes respectively. 2.2.1 Road trains with five or six axles (a) two-axle motor vehicle with three-axle trailer 40 tonnes (b) three-axle motor vehicle with two or three-axle trailer 40 tonnes 2.2.2 Articulated vehicles with five or six axles (a) two-axle motor vehicle with three-axle semi-trailer 40 tonnes (b) three-axle motor vehicle with two or three-axle semi-trailer 40 tonnes 2.2.3 Road trains with four axles consisting of a two-axle motor vehicle and a two-axle trailer 36 tonnes 2.2.4 Articulated vehicles with four axles consisting of a two-axle motor vehicle and a two-axle semi-trailer, if the distance between the axles of the semi-trailer: \u2014 is 1.3 m or greater but not more than 1.8 m 36 tonnes \u2014 is greater than 1.8 m 36 tonnes (+ 2 tonnes margin when the maximum authorised weight (MAW) of the motor vehicle (18 tonnes) and the MAW of the tandem axle of the semi-trailer (20 tonnes) are respected and the driving axle is fitted with twin tyres and air suspension or equivalent suspension) 2.3 Motor vehicles In the case of alternatively fuelled motor vehicles or zero-emission vehicles, the maximum authorised weights provided for in subsections 2.3.1 and 2.3.2 are increased by the additional weight of the alternative fuel or zero-emission technology with a maximum of 1 tonne and 2 tonnes respectively. 2.3.1 Two-axle motor vehicles 18 tonnes 2.3.2 Three-axle motor vehicles 25 tonnes (26 tonnes where the driving axle is fitted with twin tyres and air suspension or equivalent suspension, or where each driving axle is fitted with twin tyres and the maximum weight of each axle does not exceed 9.5 tonnes) 2.3.3 Four-axle motor vehicles with two steering axles 32 tonnes where the driving axle is fitted with twin tyres and air suspension or equivalent suspension, or where each driving axle is fitted with twin tyres and the maximum weight of each axle does not exceed 9.5 tonnes 3. Maximum authorised axle weight of the vehicles (in tonnes) 3.1 Single axles Single non-driving axle 10 tonnes 3.2 Tandem axles of trailers and semi-trailers The sum of the axle weights per tandem axle must not exceed, if the distance (d) between the axles is: \u2014 less than 1 m (d < 1.0) 11 tonnes \u2014 between 1.0 m and less than 1.3 m (1.0 \u2264 d < 1.3) 16 tonnes \u2014 between 1.3 m and less than 1.8 m (1.3 \u2264 d < 1.8) 18 tonnes \u2014 1.8 m or more (1.8 \u2264 d) 20 tonnes 3.3 Tri-axles of trailers and semi-trailers The sum of the axle weights per tri-axle must not exceed, if the distance (d) between the axles is: 1.3 m or less (d \u2264 1.3) 21 tonnes over 1.3 m and up to 1.4 m (1.3 <d \u2264 1.4) 24 tonnes 3.4 Driving axle Driving axle of the vehicles referred to in points 2.2 and 2.3 11.5 tonnes 3.5 Tandem axles of motor vehicles The sum of the axle weights per tandem axle must not exceed, if the distance (d) between the axles is: \u2014 less than 1 m (d < 1.0) 11.5 tonnes \u2014 1.0 m or greater but less than 1.3 m (1.0 \u2264 d < 1.3) 16 tonnes \u2014 1.3 m or greater but less than 1.8 m (1.3 \u2264 d < 1.8) 18 tonnes (19 tonnes where the driving axle is fitted with twin tyres and air suspension or equivalent suspension, or where each driving axle is fitted with twin tyres and where the maximum weight for each axle does not exceed 9.5 tonnes) 4. Other characteristics of the vehicles 4.1 All vehicles The weight borne by the driving axle or driving axles of a vehicle or vehicle combination must not be less than 25 % of the total laden weight of the vehicle or vehicle combination. 4.2 Road trains The distance between the rear axle of a motor vehicle and the front axle of a trailer must not be less than 3.00 m. 4.3 Maximum authorised weight depending on the wheelbase The maximum authorised weight in tonnes of a four-axle motor vehicle may not exceed five times the distance in metres between the axes of the foremost and rearmost axles of the vehicle. 4.4 Semi-trailers The distance measured horizontally between the axis of the fifth-wheel king pin and any point at the front of the semi-trailer must not exceed 2.04 m. SECTION 2 REQUIREMENTS FOR TACHOGRAPHS, DRIVERS' CARDS AND WORKSHOP CARDS Article 1 Subject-matter and principles This Section lays down the requirements for vehicles within the scope of Section 2 of Part B of this Annex regarding the installation, testing, and control of tachographs, as referred to in Article 466(2) of this Agreement. Article 2 Definitions 1. For the purposes of this Section, the definitions set out in Article 2 of Section 2 and in Article 2 of Section 4 of Part B of this Annex apply. 2. In addition to the definitions referred to in paragraph 1, for the purposes of this Section the following definitions apply: (a) \"vehicle unit\" means the tachograph excluding the motion sensor and the cables connecting the motion sensor. The vehicle unit may be a single unit or several units distributed in the vehicle, provided that it complies with the security requirements of this Section; the vehicle unit includes, among other things, a processing unit, a data memory, a time measurement function, two smart card interface devices for driver and co-driver, a printer, a display, connectors and facilities for entering the user's inputs; (b) \"motion sensor\" means a part of the tachograph providing a signal representative of vehicle speed and/or distance travelled; (c) \"control card\" means a tachograph card issued by the authorities of a Party to a national competent control authority which identifies the control body and, optionally, the control officer, and which allows access to the data stored in the data memory or in the driver cards and, optionally, in the workshop cards for reading, printing and/or downloading; (d) \"workshop card\" means a tachograph card issued by the authorities of a Party to designated staff of a tachograph manufacturer, a fitter, a vehicle manufacturer or a workshop, approved by that Party, which identifies the cardholder and allows for the testing, calibration and activation of tachographs, and/or downloading from them; (e) \"activation\" means the phase in which the tachograph becomes fully operational and implements all functions, including security functions, through the use of a workshop card; (f) \"calibration\" means, with regard to the digital tachograph, updating or confirming vehicle parameters, including vehicle identification and vehicle characteristics, to be held in the data memory through the use of a workshop card; (g) \"downloading\" from a digital or smart tachograph means the copying, together with the digital signature, of a part, or of a complete set, of data files recorded in the data memory of the vehicle unit or in the memory of a tachograph card, provided that this process does not alter or delete any stored data; (h) \"fault\" means an abnormal operation detected by the digital tachograph which may result from an equipment malfunction or failure; (i) \"installation\" means the mounting of a tachograph in a vehicle; (j) \"periodic inspection\" means a set of operations performed to check that the tachograph works properly, that its settings correspond to the vehicle parameters, and that no manipulation devices are attached to the tachograph; (k) \"repair\" means any repair of a motion sensor or of a vehicle unit that requires the disconnection of its power supply, or its disconnection from other tachograph components, or the opening of the motion sensor or vehicle unit; (l) \"interoperability\" means the capacity of systems and the underlying business processes to exchange data and to share information; (m) \"interface\" means a facility between systems which provides the media through which they can connect and interact; (n) \"time measurement\" means a permanent digital record of the coordinated universal date and time (UTC); and (o) \"TACHOnet messaging system\" means the messaging system complying with the technical specifications laid down in Annexes I to VII of Commission Implementing Regulation (EU) 2016/68 (7). Article 3 Installation 1. Tachographs as referred to in paragraph 2 shall be installed in vehicles: (a) where the maximum permissible mass of the vehicle, including any trailer, or semitrailer, exceeds 3.5 tonnes; or (b) from 1 July 2026, where the maximum permissible mass of the vehicle, including any trailer, or semi-trailer, exceeds 2.5 tonnes. 2. The tachographs are: (a) for vehicles put into service for the first time before 1 May 2006, an analogue tachograph; (b) for vehicles put into service for the first time between 1 May 2006 and 30 September 2011, the first version of the digital tachograph; (c) for vehicles put into service for the first time between 1 October 2011 and 30 September 2012, the second version of the digital tachograph; (d) for vehicles put into service for the first time between 1 October 2012 and 14 June 2019, the third version of the digital tachograph; (e) for vehicles registered for the first time from 15 June 2019 and until 2 years after the entry into force of the detailed specifications referred to in Article 2(2)(g) of Section 4 of Part B, a smart tachograph 1; and (f) for vehicles registered for the first time more than 2 years after the entry into force of the detailed specifications referred to in Article 2(2)(h) of Section 4 of Part B, a smart tachograph 2. 3. Each Party may exempt from the application of this Section the vehicles mentioned in Article 8(3) of Section 2 of Part B of this Annex. 4. Each Party may exempt from the application of this Section vehicles used for transport operations which have been granted an exception in accordance with Article 8(4) of Section 2 of Part B of this Annex. Each Party shall immediately notify each other when making use of this paragraph. 5. No later than three years from the end of the year of entry into force of the detailed technical specifications of the smart tachograph 2, vehicles mentioned in point (a) of paragraph 1 which are equipped with an analogue tachograph or a digital tachograph shall be fitted with a smart tachograph 2 when operating on the territory of a Party other than the one where they are registered. 6. No later than four years after the entry into force of the detailed technical specifications of the smart tachograph 2, vehicles mentioned in point (a) of paragraph 1 equipped with a smart tachograph 1, shall be equipped with a smart tachograph 2 when operating on the territory of a Party other than the one where they are registered. 7. From 1 July 2026, vehicles mentioned in point (b) of paragraph 1 shall be equipped with a smart tachograph 2 when operating on the territory of a Party other than the one where they are registered. 8. Nothing in this Section shall affect the application on the Union territory of the Union rules on recording equipment in road transport to Union road haulage operators. Article 4 Data protection 1. Each Party shall ensure that the processing of personal data in the context of this Section is carried out solely for the purpose of verifying compliance with this Section. 2. Each Party shall, in particular, ensure that personal data are protected against uses other than the one strictly referred to in paragraph 1 in relation to: (a) the use of a global navigation satellite system (GNSS) for the recording of location data as referred to in the technical specification for smart tachograph 1 and smart tachograph 2; (b) the electronic exchange of information on driver cards as referred to in Article 13, and in particular any cross-border exchanges of such data with third Parties; and (c) the keeping of records by road haulage operators as referred to in Article 15. 3. Digital tachographs shall be designed in such a way as to ensure privacy. Only data necessary for the purposes referred to in paragraph 1 shall be processed. 4. Owners of vehicles, road haulage operators and any other entity concerned shall comply with the relevant provisions on the protection of personal data. Article 5 Installation and repair 1. Tachographs may be installed or repaired only by fitters, workshops or vehicle manufacturers approved by the competent authorities in a Party for that purpose in accordance with Article 7. 2. Approved fitters, workshops or vehicle manufacturers shall seal the tachograph after having verified that it is functioning properly, and, in particular, in such a way as to ensure that no manipulation device can tamper with or alter the data recorded. 3. The approved fitter, workshop or vehicle manufacturer shall place a special mark on the seals which it affixes and, in addition, for digital, smart 1 and smart 2 tachographs, shall enter the electronic security data for carrying out authentication checks. Each Party shall keep and publish a register of the marks and electronic security data used and the necessary information related to the electronic security data used. 4. For the purpose of certifying that the installation of the tachograph took place in accordance with the requirements of this Section, an installation plaque shall be affixed in such a way as to be clearly visible and easily accessible. 5. Tachograph components shall be sealed. Any connections to the tachograph which are potentially vulnerable to tampering, including the connection between the motion sensor and the gearbox, and the installation plaque where relevant, shall be sealed. A seal shall be removed or broken only: \u2014 by fitters or workshops approved by the competent authorities under Article 7 for repair, maintenance or recalibration purposes of the tachograph, or by control officers properly trained and, where required authorised, for control purposes; or \u2014 for the purpose of vehicle repair or modification which affects the seal. In such cases, a written statement stating the date and time at which the seal was broken and giving the reasons for the seal removal shall be kept on board the vehicle. The removed or broken seals shall be replaced by an approved fitter or a workshop without undue delay and at the latest within seven days of their removal or breaking. When the seals have been removed or broken for control purposes, they may be replaced by a control officer equipped with sealing equipment and a unique special mark without undue delay. When a control officer removes a seal, the control card shall be inserted in the tachograph from the moment of the removal of the seal until the inspection is finished, including in the case of the placement of a new seal. The control officer shall issue a written statement containing at least the following information: \u2014 vehicle identification number; \u2014 name of the officer; \u2014 control authority and country; \u2014 number of the control card; \u2014 number of the removed seal; \u2014 date and time of seal removal; and \u2014 number of the new seal, where the control officer has placed a new seal. Before replacing the seals, a check and calibration of the tachograph shall be performed by an approved workshop, except where a seal has been removed or broken for control purposes and replaced by a control officer. Article 6 Inspections of tachographs 1. Tachographs shall be subject to regular inspection by approved workshops. Regular inspections shall be carried out at least every two years. 2. The inspections referred to in paragraph 1 shall check at least the following: \u2014 the tachograph is correctly fitted and appropriate for the vehicle; \u2014 the tachograph is working properly; \u2014 the tachograph carries the type-approval mark; \u2014 the installation plaque is affixed; \u2014 all seals are intact and effective; \u2014 there are no manipulation devices attached to the tachograph or traces of the use of such devices; and \u2014 the tyre size and the actual circumference of the tyres. 3. Workshops shall draw up an inspection report in cases where irregularities in the functioning of the tachograph had to be remedied, whether as a result of a periodic inspection or of an inspection carried out at the specific request of the national competent authority. They shall keep a list of all inspection reports drawn up. 4. Inspection reports shall be retained for a minimum period of two years from the time the report was made. Each Party shall decide whether inspection reports are to be retained or sent to the competent authority during that period. In cases where the inspection reports are kept by the workshop, upon request from the competent authority, the workshop shall make available the reports of inspections and calibrations carried out during that period. Article 7 Approval of fitters, workshops and vehicle manufacturers 1. Each Party or, in the case of the Union, each Member State shall approve, regularly control and certify the fitters, workshops and vehicle manufacturers which may carry out installations, checks, inspections and repairs of tachographs. 2. Each Party or, in the case of the Union, each Member State shall ensure that fitters, workshops and vehicle manufacturers are competent and reliable. For that purpose, they shall establish and publish a set of clear national procedures and shall ensure that the following minimum criteria are met: (a) the staff are properly trained; (b) the equipment necessary to carry out the relevant tests and tasks is available; and (c) the fitters, workshops and vehicle manufacturers are of good repute. 3. Audits of approved fitters or workshops shall be carried out as follows: (a) approved fitters or workshops shall be subject, at least every two years, to an audit of the procedures they apply when handling tachographs. The audit shall focus in particular on the security measures taken and the handling of workshop cards. Parties or, in the case of the Union, Member States may carry out these audits without conducting a site visit; and (b) unannounced technical audits of approved fitters or workshops shall also take place in order to check the calibrations, inspections and installations carried out. Those audits shall cover at least 10 % of the approved fitters and workshops annually. 4. Each Party and their competent authorities shall take appropriate measures to prevent conflicts of interests between fitters or workshops and road haulage operators. In particular, where there is a serious risk of a conflict of interests, additional specific measures shall be taken to ensure that the fitter or workshop complies with this Section. 5. The competent authorities of each Party shall withdraw approvals, either temporarily or permanently, from fitters, workshops and vehicle manufacturers which fail to meet their obligations under this Section. Article 8 Workshop cards 1. The period of validity of workshop cards shall not exceed one year. When renewing the workshop card, the competent authority shall ensure that the criteria listed in Article 7(2) are met by the fitter, workshop or vehicle manufacturer. 2. The competent authority shall renew a workshop card within 15 working days after receipt of a valid renewal request and all the necessary documentation. If a workshop card is damaged, malfunctions, or is lost or stolen, the competent authority shall supply a replacement card within five working days of receiving a detailed request to that effect. Competent authorities shall maintain a register of lost, stolen or defective cards. 3. If a Party or, in the case of the Union, a Member State withdraws the approval of a fitter, workshop or vehicle manufacturer as provided for in Article 7, it shall also withdraw the workshop cards issued thereto. 4. Each Party shall take all necessary measures to prevent the workshop cards distributed to approved fitters, workshops and vehicle manufacturers from being falsified. Article 9 Issuing of driver cards 1. Driver cards shall be issued, at the request of the driver, by the competent authority in a Party where the driver has his normal residence. Where the competent authorities in a Party issuing the driver card have doubts as to the validity of a statement as to normal residence, or for the purpose of certain specific controls, they may request any additional information or evidence from the driver. For the purposes of this Article, \"normal residence\" means the place where a person usually lives, that is for at least 185 days in each calendar year, because of personal and occupational ties, or, in the case of a person with no occupational ties, because of personal ties which show close links between that person and the place where he is living. However, the normal residence of a person whose occupational ties are in a place different from their personal ties and who consequently lives in turn in different places situated in the two Parties shall be regarded as being the place of their personal ties, provided that such person returns there regularly. This last condition need not be complied with where the person is living in a Party in order to carry out a fixed-term assignment. 2. In duly justified and exceptional cases, each Party or, in the case of the Union, a Member State may issue a temporary and non-renewable driver card valid for a maximum period of 185 days to a driver who does not have his normal residence in a Party, provided that such driver is in a labour law relationship with an undertaking established in the issuing Party and, in so far, presents a driver attestation when required. 3. The competent authorities of the issuing Party shall take appropriate measures to ensure that an applicant does not already hold a valid driver card and shall personalise the driver card, ensuring that its data are visible and secure. 4. The driver card shall not be valid for more than five years. 5. A valid driver card shall not be withdrawn or suspended unless the competent authorities of a Party find that the card has been falsified, or the driver is using a card of which he is not the holder, or the card held has been obtained on the basis of false declarations and/or forged documents. If such suspension or withdrawal measures are taken by a Party or, in the case of the Union, a Member State other than the issuing Party or, in the case of the Union, other than the issuing Member State, the former shall return the card to the authorities of the Party or, in the case of the Union, the authorities of the Member State which issued it, as soon as possible, indicating the reasons for the withdrawal or suspension. If the return of the card is expected to take longer than two weeks, the suspending or withdrawing Party or, in the case of the Union, the suspending or withdrawing Member State shall inform the issuing Party or, in the case of the Union, the issuing Member State within those two weeks of the reasons for suspension or withdrawal. 6. The competent authority of the issuing Party may require a driver to replace the driver card by a new one if this is necessary to comply with the relevant technical specifications. 7. Each Party shall take all necessary measures to prevent driver cards from being falsified. 8. This Article shall not prevent a Party or, in the case of the Union, a Member State from issuing a driver card to a driver who has his normal residence in a part of that Party's territory, to which this Annex does not apply, provided that the relevant provisions of this Section are applied in such cases. Article 10 Renewal of driver cards 1. Where, in the case of renewals, the Party of the driver's normal residence is different from that which issued his current card, and where the authorities of the former Party are requested to renew the driver card, they shall inform the authorities which issued the earlier card of the reasons for its renewal. 2. In the event of a request for the renewal of a card which is imminently about to expire, the competent authority shall supply a new card before the expiry date, provided that the request was sent within the time-limits laid down in Article 5 of Section 4 of Part B. Article 11 Stolen, lost or defective driver cards 1. Issuing authorities shall keep records of issued, stolen, lost or defective driver cards for a period at least equivalent to their period of validity. 2. If the driver card is damaged, malfunctions or is lost or stolen, the competent authorities in the Party of his normal residence shall supply a replacement card within eight working days after their receipt of a detailed request to that effect. Article 12 Mutual acceptance of driver cards 1. Each Party shall accept the driver cards issued by the other Party. 2. Where the holder of a valid driver card issued by a Party has established his normal residence in the other Party and has asked for his card to be exchanged for an equivalent driver card, it shall be the responsibility of the Party or, in the case of the Union, the Member State which carries out the exchange to verify whether the card produced is still valid. 3. Parties or, in the case of the Union, Member States carrying out an exchange shall return the old card to the authorities of the issuing Party or, in the case of the Union, the issuing Member State and indicate the reasons for so doing. 4. Where a Party or, in the case of the Union, a Member State replaces or exchanges a driver card, the replacement or exchange, and any subsequent replacement or exchange, shall be registered in that Party or, in the case of the Union, in that Member State. Article 13 Electronic exchange of information on driver cards 1. In order to ensure that an applicant does not already hold a valid driver card, Parties or, in the case of the Union, Member States shall maintain national electronic registers containing the following information on driver cards for a period at least equivalent to the period of validity of those cards: \u2014 surname and first name of the driver; \u2014 birth date and, if available, place of birth of the driver; \u2014 valid driving licence number and country of issue of the driving licence (if applicable); \u2014 status of the driver card; and \u2014 driver card number. 2. The electronic registers of the Parties or, in the case of the Union, the Member States shall be interconnected and accessible throughout the territory of the Parties, using the TACHOnet messaging system or a compatible system. In the case of the use of a compatible system, the exchange of electronic data with the other Party shall be possible through the TACHOnet messaging system. 3. When issuing, replacing and, where necessary, renewing a driver card, Parties or, in the case of the Union, Member States shall verify through electronic data exchange that the driver does not already hold another valid driver card. The data exchanged shall be limited to the data necessary for the purpose of this verification. 4. Control officers may have access to the electronic register in order to check the status of a driver card. Article 14 Settings of tachographs 1. Digital tachographs shall not be set in such a way that they automatically switch to a specific category of activity when the vehicle's engine or ignition is switched off, unless the driver remains able to choose manually the appropriate category of activity. 2. Vehicles shall not be fitted with more than one tachograph, except for the purposes of field tests. 3. Each Party shall forbid the production, distribution, advertising and/or selling of devices constructed and/or intended for the manipulation of tachographs. Article 15 Responsibility of road haulage operators 1. Road haulage operators shall be responsible for ensuring that their drivers are properly trained and instructed as regards the correct functioning of tachographs, whether digital, smart or analogue, shall make regular checks to ensure that their drivers make correct use thereof, and shall not give to their drivers any direct or indirect incentives that could encourage the misuse of tachographs. Road haulage operators shall issue a sufficient number of record sheets to drivers of vehicles fitted with analogue tachographs, taking into account the fact that record sheets are personal in character, the length of the period of service and the possible need to replace record sheets which are damaged or have been taken by an authorised control officer. Road haulage operators shall issue to drivers only record sheets of an approved model suitable for use in the equipment installed in the vehicle. The road haulage operator shall ensure that, taking into account the length of the period of service, the printing of data from the tachograph at the request of a control officer can be carried out correctly in the event of an inspection. 2. Road haulage operators shall keep record sheets and printouts, whenever printouts have been made to comply with Article 9 of Section 4 of Part B of this Annex, in chronological order and in a legible form, for at least a year after their use, and shall give copies to the drivers concerned who request them. Road haulage operators shall also give copies of data downloaded from driver cards to the drivers concerned who request them, together with printed paper versions of those copies. Record sheets, printouts and downloaded data shall be produced or handed over at the request of any authorised control officer. 3. Road haulage operators shall be liable for infringements of this Section and of Section 4 of Part B of this Annex committed by their drivers or by drivers at their disposal. However, each Party may make such liability conditional on the road haulage operator's infringement of the first subparagraph of paragraph 1 of this Article and Article 7(1) and (2) of Section 2 of Part B of this Annex. Article 16 Procedures for road haulage operators in the event of malfunctioning equipment 1. In the event of the breakdown or faulty operation of a tachograph, the road haulage operator shall have it repaired by an approved fitter or workshop, as soon as circumstances permit. 2. If the vehicle is unable to return to the road haulage operator's premises within a period of one week calculated from the day of the breakdown or of the discovery of defective operation, the repair shall be carried out en route. 3. Each Party or, in the case of the Union, the Member States shall give the competent authorities power to prohibit the use of the vehicle in cases where the breakdown or faulty operation has not been remedied as provided in paragraphs 1 and 2 in so far as this is in accordance with the national legislation in the Party concerned. Article 17 Procedure for the issuing of tachograph cards The European Commission shall provide to the competent authorities of the United Kingdom the cryptographic material for the issuing of tachograph cards for drivers, workshops and control authorities, in accordance with the European Root Certification Authority (ERCA) certificate policy and the certificate policy of the United Kingdom. (1) Established by Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC (\"the IMI Regulation\") (OJ EU L 316, 14.11.2012, p. 1). (2) Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC (\"the IMI Regulation\") (OJ EU L 316, 14.11.2012, p. 1). (3) Regulation (EU) No 165/2014 of the European Parliament and of the Council of 4 February 2014 on tachographs in road transport, repealing Council Regulation (EEC) No 3821/85 on recording equipment in road transport and amending Regulation (EC) No 561/2006 of the European Parliament and of the Council on the harmonisation of certain social legislation relating to road transport (OJ EU L 60, 28.2.2014, p. 1). (4) Commission Implementing Regulation (EU) 2016/799 of 18 March 2016 implementing Regulation (EU) No 165/2014 of the European Parliament and of the Council laying down the requirements for the construction, testing, installation, operation and repair of tachographs and their components (OJ EU L 139, 26.5.2016, p. 1). (5) Regulation (EU) No 165/2014 of the European Parliament and of the Council of 4 February 2014 on tachographs in road transport, repealing Council Regulation (EEC) No 3821/85 on recording equipment in road transport and amending Regulation (EC) No 561/2006 of the European Parliament and of the Council on the harmonisation of certain social legislation relating to road transport (OJ EU L 60, 28.2.2014, p. 1). (6) Council Regulation (EC) No 2135/98 of 24 September 1998 amending Regulation (EEC) No 3821/85 on recording equipment in road transport and Directive 88/599/EEC concerning the application of Regulations (EEC) No 3820/84 and (EEC) No 3821/85 (OJ EC L 274, 9.10.1998, p. 1). (7) Commission Implementing Regulation (EU) 2016/68 of 21 January 2016 on common procedures and specifications necessary for the interconnection of electronic registers of driver cards (OJ EU L 15, 22.1.2016, p. 51). ANNEX 32 MODEL OF AUTHORISATION FOR AN INTERNATIONAL REGULAR AND SPECIAL REGULAR SERVICE (First page of authorisation) (Orange paper \u2013 DIN A4) (To be worded in the official language(s) or one of the official languages of the Party where the request is made) Authorisation In accordance with Title II of Heading Three of Part Two of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, ISSUING STATE: \u2026 Authorising authority: \u2026 Issuing State distinguishing sign: \u2026 (1) AUTHORISATION No.: \u2026 for a regular service \u2610 ( 2 ) for a special regular service \u2610 (2) by coach and bus between the Parties to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, To: \u2026 \u2026 Last name, first name or trade name of the operator or of the managing operator in the case of a group of undertakings or in the case of a partnership: Address: \u2026 \u2026 Telephone and fax or e-mail: \u2026 \u2026 (Second page of authorisation) Name, address, telephone and fax or e-mails of the operator, or, in the case of groups of operators or partnerships, the names of all operators of the group or of the partnership; in addition, names of any subcontractors, to be identified as such: (1) \u2026 (2) \u2026 (3) \u2026 (4) \u2026 (5) \u2026 List attached, if appropriate Validity of the authorisation: From: \u2026 To: \u2026 Place and date of issue: \u2026 Signature and stamp of the issuing authority or agency: \u2026 1. Route: \u2026 \u2026 (a) Place of departure of service: \u2026 \u2026 (b) Place of destination of service: \u2026 \u2026 Principal itinerary, with passenger pick-up and set-down points underlined: \u2026 \u2026 2. Timetable: \u2026 (attached to this authorisation) 3. Special regular service: (a) Category of passengers: \u2026 \u2026 4. Other conditions or special points \u2026 \u2026 \u2026 Stamp of authority issuing the authorisation Important notice: (1) This authorisation is valid for the entire journey. (2) The authorisation or a true copy certified by the issuing authorising authority shall be kept on the vehicle for the duration of the journey and shall be presented to enforcement officials on request. (3) The departure or destination shall take place in the territory of the Party where the operator is established and the coaches and buses registered. (Third page of authorisation) GENERAL CONSIDERATIONS (1) The road passenger transport operator shall begin the transport service within the period indicated in the decision of the authorising authority granting the authorisation. (2) Except in the event of force majeure, the operator of an international regular or special regular service shall take all measures to guarantee a transport service that complies with the conditions as stipulated in the authorisation. (3) The operator shall make the information about the route, the stopping points, the timetable, the fares and the conditions of transport publicly available. (4) Without prejudice to documents pertaining to the vehicle and driver (such as the vehicle registration certificate and driving licence), the following documents shall serve as control documents required under Article 477 of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part and shall be kept in the vehicle and presented at the request of any authorised inspecting officer: \u2014 the authorisation or a certified true copy thereof to carry out international regular or special regular services; \u2014 the operator's licence or a certified true copy thereof for the international carriage of passengers by road provided for according to the United Kingdom or Union legislation; \u2014 when operating an international special regular service, the contract between the organiser and the transport operator or a certified true copy thereof as well as a document evidencing that the passengers constitute a specific category to the exclusion of other passengers for the purposes of a special regular service; \u2014 when the operator of a regular or special regular service uses additional vehicles to deal with temporary and exceptional situations, in addition to the relevant documents mentioned above, a copy of the contract between the operator of the international regular or special regular service and the undertaking providing the additional vehicles or an equivalent document. (Fourth page of authorisation) GENERAL CONSIDERATIONS (cont.) (5) Operators operating an international regular service, with the exclusion of special regular service, shall issue transport tickets confirming the rights of the passenger to be transported and serving as a control document evidencing of the conclusion of the contract of carriage between the passenger and the transport operator, either individual or collective. The tickets that can also be electronic shall indicate: (a) the name of the operator; (b) the points of departure and destination and, if applicable, the return journey; (c) the period of validity of the ticket and, if applicable, the date and time of departure; (d) the price of transport. The transport ticket shall be presented, by the passenger, at the request of any authorised inspection officer. (6) Operators operating international regular or special regular passenger transport services shall allow all inspections intended to ensure that operations are being conducted correctly, in particular as regards driving and rest periods and road safety and emissions. (1) Austria (A), Belgium (B), Bulgaria (BG), Cyprus (CY), Croatia (HR), Czech Republic (CZ), Denmark (DK), Estonia (EST), Finland (FIN), France (F), Germany (D), Greece (GR), Hungary (H), Ireland (IRL), Italy (I), Latvia (LV), Lithuania (LT), Luxembourg (L), Malta (MT), Netherlands (NL), Poland (PL), Portugal (P), Romania (RO), Slovak Republic (SK), Slovenia (SLO), Spain (E), Sweden (S), United Kingdom (UK), to be completed/ (2) Tick or complete as appropriate. ANNEX 33 MODEL OF APPLICATION FOR AN AUTHORISATION FOR AN INTERNATIONAL REGULAR AND SPECIAL REGULAR SERVICE (White paper \u2013 DIN A4) (To be worded in the official language(s) or one of the official languages of the Party where the request is made) APPLICATION FORM FOR AN AUTHORISATION OR RENEWAL OF AN AUTHORISATION TO CARRY OUT AN INTERNATIONAL REGULAR SERVICE OR AN INTERNATIONAL SPECIAL REGULAR SERVICE (1) To start a regular service \u2610 To start a special regular service \u2610 To renew authorisation for a service \u2610 To alter the conditions of authorisation for a service \u2610 carried out by coach and bus between Parties in accordance with the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, \u2026 (Authorising authority) 1. Name and first name or trade name of the applicant operator; in the case of an application by a group of operators or by a partnership, the name of the operator entrusted by the other operators for the purposes of submitting the application: \u2026 \u2026 2. Services to be carried out(1) By an operator \u2610 by a group of operators \u2610 by a partnership \u2610 by a subcontractor \u2610 3. Names and addresses of the operator or, in the case of a group of operators or of a partnership, the names of all operators of the group or of the partnership; in addition, any subcontractors shall be identified by their names (2) 3.1 \u2026. tel. \u2026 3.2 \u2026. tel. \u2026 3.3 \u2026. tel. \u2026 3.4 \u2026. tel. \u2026 (Second page of the application for authorisation or renewal of authorisation) 4 In the case of a special regular service: 4.1 Category of passengers: (3) workers \u2610 school pupils/students \u2610 other \u2610 5 Duration of authorisation requested or date on which the service ends: \u2026 6 Principal route of service (underline passenger pick-up and set-down points, with full addresses): (4) \u2026 \u2026 \u2026 7 Period of operation: \u2026 \u2026 \u2026 8 Frequency (daily, weekly, etc.): \u2026 9 Fares \u2026 Annex attached. 10 Enclose a driving schedule to permit verification of compliance with the international rules on driving times and rest time periods. 11 Number of authorisations or of certified true copies of authorisations requested: (5) \u2026 12 Any additional information: \u2026 (Place and date) (Signature of applicant) \u2026 The attention of the applicant is drawn to the fact that, since the authorisation or its certified true copy has to be kept on board the vehicle, the number of authorisations or certified true copies, issued by the authorising authority, which the applicant must have should correspond to the number of vehicles needed for carrying out the service requested at the same time. Important notice In particular the following must be attached to the application: (a) the timetable including the time slots for controls at relevant border crossings; (b) a certified true copy of the operator's (or operators') licence(s) for the international carriage of passengers by road provided for according to national or Union legislation; (c) a map on an appropriate scale on which are marked the route and the stopping points at which passengers are to be taken up or set down; (d) a driving schedule to permit verification of compliance with the international rules on driving times and rest periods; (e) any appropriate information concerning coach and bus terminals. (1) Tick or complete as appropriate. (2) Attach list if applicable. (3) Tick or complete as appropriate. (4) The authorising authority may request a full list of passenger pick-up and set-down points with full addresses to be attached separately to this application form. (5) Complete as appropriate/ ANNEX 34 MODEL OF JOURNEY FORM FOR OCCASIONAL SERVICES JOURNEY FORM No \u2026 of Book No \u2026 (colour Pantone 358 (light green), or as close as possible to this colour, format DIN A4 uncoated paper) OCCASIONAL SERVICES WITH CABOTAGE AND OCCASIONAL SERVICES WITH TRANSIT (Each item, if necessary, can be supplemented on a separate sheet) 1 Registration number of the coach \u2026 Place, date and signature of the carrier 2 1. \u2026 2. \u2026 3. \u2026 Carrier and, where appropriate, subcontractor or group of carriers 3 1. \u2026 2. \u2026 3. \u2026 Name of driver(s) 4 Organisation of person responsible for the occasional service 1. \u2026 2. \u2026 3. \u2026 4. \u2026. 5 Type of service \u2610 Occasional service with cabotage \u2610 Occasional service with transit 6 Place of departure of service: \u2026 Country: \u2026 Place of destination of service: \u2026 Country: \u2026 7 Journey Route/Daily stages and/or passenger pick-up or set-down points Number of passengers Empty (mark with an X ) Planned km Dates From To 8 Connection points, if any, with another carrier in the same group Number of passengers set down Final destination of the passengers set down Carrier picking up the passengers 9 Unforeseen changes \u2026 \u2026 ANNEX 35 # Code Common Name ICES Areas Shares 2021 2022 2023 2024 2025 2026 onwards EU UK EU UK EU UK EU UK EU UK EU UK 1 ALF/3X14- Alfonsinos (3,4,5,6,7,8,9, 10,12,14) UK, Union and international waters of 3, 4, 5, 6, 7, 8, 9, 10, 12 and 14 96.95 3.05 96.95 3.05 96.95 3.05 96.95 3.05 96.95 3.05 96.95 3.05 2 ANF/07. Anglerfish (7) 7 78.78 21.22 78.24 21.76 77.70 22.30 77.05 22.95 76.62 23.38 76.62 23.38 3 ANF/2AC4-C Anglerfish (North Sea) UK and Union waters 4; UK waters of 2a 13.74 86.26 12.92 87.08 12.11 87.89 11.13 88.87 10.48 89.52 10.48 89.52 4 ANF/56-14 Anglerfish (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 60.99 39.01 59.62 40.38 58.25 41.75 56.60 43.40 55.50 44.50 55.50 44.50 5 ARU/1/2. Greater Silver Smelt (1,2) UK and international waters of 1 and 2 56.90 43.10 56.90 43.10 56.90 43.10 56.90 43.10 56.90 43.10 56.90 43.10 6 ARU/3A4-C Greater Silver Smelt (North Sea) UK and Union waters of 4; Union waters of 3a 98.40 1.60 98.40 1.60 98.40 1.60 98.40 1.60 98.40 1.60 98.40 1.60 7 ARU/567. Greater Silver Smelt (Western) 6 and 7; UK and international waters of 5 94.41 5.59 94.41 5.59 94.41 5.59 94.41 5.59 94.41 5.59 94.41 5.59 8 BLI/12INT- Blue Ling (International 12) International waters of 12 99.14 0.86 99.14 0.86 99.14 0.86 99.14 0.86 99.14 0.86 99.14 0.86 9 BLI/24- Blue Ling (North Sea) UK and international waters of 2; UK and Union waters of 4 73.19 26.81 73.19 26.81 73.19 26.81 73.19 26.81 73.19 26.81 73.19 26.81 10 BLI/5B67- Blue Ling (Western) 6 and 7; UK and international waters of 5 77.31 22.69 76.73 23.27 76.16 23.84 75.46 24.54 75.00 25.00 75.00 25.00 11 BOR/678- Boarfish (Western) 6, 7 and 8 93.65 6.36 93.65 6.36 93.65 6.36 93.65 6.36 93.65 6.36 93.65 6.36 12 BSF/56712- Black Scabbardfish (Western) 6 and 7; UK and international waters of 5; international waters of 12 94.31 5.69 94.31 5.69 94.31 5.69 94.31 5.69 94.31 5.69 94.31 5.69 13 COD/07A. Cod (Irish Sea) 7a 56.05 43.95 55.84 44.16 55.63 44.37 55.37 44.63 55.20 44.80 55.20 44.80 14 COD/07D. Cod (Eastern Channel) 7d 90.75 9.25 90.75 9.25 90.75 9.25 90.75 9.25 90.75 9.25 90.75 9.25 15 COD/5BE6A Cod (West of Scotland) 6a; UK and international waters of 5b east of 12\u00b000' W 30.23 69.77 27.37 72.63 24.51 75.49 21.08 78.92 18.79 81.21 18.79 81.21 16 COD/5W6-14 Cod (Rockall) 6b; UK and international waters of 5b west of 12\u00b000' W and of 12 and 14 33.95 66.05 31.71 68.29 29.47 70.53 26.78 73.22 24.99 75.01 24.99 75.01 17 COD/7XAD34 Cod (Celtic Sea) 7b, 7c, 7e-k, 8, 9 and 10; Union waters of CECAF 34.1.1 90.70 9.30 90.47 9.53 90.23 9.77 89.95 10.05 89.76 10.24 89.76 10.24 18 DGS/15X14 Spurdog (Western) 6, 7 and 8; UK and international waters of 5; international waters of 1, 12 and 14 57.53 42.47 56.61 43.39 55.69 44.31 54.58 45.42 53.84 46.16 53.84 46.16 19 DWS/56789- Deep-sea Sharks (Western) 6, 7, 8 and 9; UK and international waters of 5 100.00 0.00 100.00 0.00 100.00 0.00 100.00 0.00 100.00 0.00 100.00 0.00 20 HAD/07A. Haddock (Irish Sea) 7a 47.24 52.76 46.42 53.58 45.61 54.39 44.63 55.37 43.98 56.02 43.98 56.02 21 HAD/5BC6A. Haddock (West of Scotland) 6a; UK and international waters of 5b 19.39 80.61 19.39 80.61 19.39 80.61 19.39 80.61 19.39 80.61 19.39 80.61 22 HAD/6B1214 Haddock (Rockall) UK, Union and international waters of 6b; international waters 12 and 14 16.76 83.24 16.32 83.68 15.88 84.12 15.35 84.65 15.00 85.00 15.00 85.00 23 HAD/7X7A34 Haddock (Celtic Sea) 7b-k, 8, 9 and 10; Union waters of CECAF 34.1.1 84.00 16.00 83.00 17.00 82.00 18.00 80.80 19.20 80.00 20.00 80.00 20.00 24 HER/07A/MM Herring (Irish Sea) 7a north of 52\u00b030\u2019N 11.01 88.99 8.50 91.50 6.00 94.00 2.99 97.01 0.99 99.01 0.99 99.01 25 HER/5B6ANB Herring (West of Scotland) 6b and 6aN; UK and international waters 5b 35.95 64.05 35.34 64.66 34.74 65.26 34.01 65.99 33.53 66.47 33.53 66.47 26 HER/7EF. Herring (Western Channel and Bristol Channel) 7e and 7f 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 27 HER/7G-K. Herring (Celtic Sea) 7a south of 52\u00b030\u2019N, 7g, 7h, 7j and 7k 99.88 0.12 99.88 0.12 99.88 0.12 99.88 0.12 99.88 0.12 99.88 0.12 28 HKE/2AC4-C Hake (North Sea) UK and Union waters 4; UK waters of 2a 60.67 39.33 57.11 42.89 53.56 46.44 49.29 50.71 46.45 53.55 46.45 53.55 29 HKE/571214 Hake (Western) 6 and 7; UK and international waters of 5b; international waters of 12 and 14 80.33 19.67 80.05 19.95 79.77 20.23 79.43 20.57 79.20 20.80 79.20 20.80 30 JAX/2A-14 Horse Mackerel (Western) UK and Union waters of 4a; 6, 7a-c, e-k; 8a-b, d-e; UK and international waters of 2a and 5b; international waters of 12 and 14 90.61 9.39 90.61 9.39 90.61 9.39 90.61 9.39 90.61 9.39 90.61 9.39 31 JAX/4BC7D Horse Mackerel (Southern North Sea and Eastern Channel) UK and Union waters of 4b, 4c and 7d 71.46 28.54 68.60 31.40 65.73 34.27 62.29 37.71 60.00 40.00 60.00 40.00 32 L/W/2AC4-C Lemon Sole and Witch (North Sea)* UK and Union waters of 4; UK waters of 2a 35.97 64.03 35.48 64.52 34.98 65.02 34.39 65.61 34.00 66.00 34.00 66.00 33 LEZ/07. Megrims (7) 7 81.37 18.63 80.65 19.35 79.93 20.07 79.07 20.93 78.50 21.50 78.50 21.50 34 LEZ/2AC4-C Megrims (North Sea) UK and Union waters 4; UK waters of 2a 3.74 96.26 3.74 96.26 3.74 96.26 3.74 96.26 3.74 96.26 3.74 96.26 35 LEZ/56-14 Megrims (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 60.84 39.16 59.55 40.45 58.25 41.75 56.69 43.31 55.65 44.35 55.65 44.35 36 LIN/03A-C. Ling (3a) Union waters of 3a 92.65 7.35 92.65 7.35 92.65 7.35 92.65 7.35 92.65 7.35 92.65 7.35 37 LIN/04-C. Ling (North Sea) UK and Union waters of 4 21.22 78.78 20.92 79.08 20.61 79.39 20.24 79.76 20.00 80.00 20.00 80.00 38 LIN/6X14. Ling (Western) 6, 7, 8, 9 and 10; international waters of 12 and 14 63.67 36.33 63.25 36.75 62.83 37.17 62.33 37.67 62.00 38.00 62.00 38.00 39 NEP/*07U16 Nephrops (Porcupine Bank) Functional Unit 16 of ICES Subarea 7 85.32 14.68 85.32 14.68 85.32 14.68 85.32 14.68 85.32 14.68 85.32 14.68 40 NEP/07. Nephrops (7) 7 61.68 38.32 60.76 39.24 59.84 40.16 58.74 41.26 58.00 42.00 58.00 42.00 41 NEP/2AC4-C Nephrops (North Sea) UK and Union waters 4; UK waters of 2a 13.38 86.62 13.38 86.62 13.38 86.62 13.38 86.62 13.38 86.62 13.38 86.62 42 NOP/2A3A4. Norway Pout (North Sea) 3a; UK and Union waters and 4; UK waters of 2a 85.00 15.00 82.50 17.50 80.00 20.00 77.00 23.00 75.00 25.00 75.00 25.00 43 PLE/07A. Plaice (Irish Sea) 7a 48.89 51.11 48.89 51.11 48.89 51.11 48.89 51.11 48.89 51.11 48.89 51.11 44 PLE/56-14 Plaice (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 39.23 60.77 39.23 60.77 39.23 60.77 39.23 60.77 39.23 60.77 39.23 60.77 45 PLE/7DE. Plaice (English Channel)* 7d and 7e 70.36 29.64 70.27 29.73 70.18 29.82 70.07 29.93 70.00 30.00 70.00 30.00 46 PLE/7FG. Plaice (7fg) 7f and 7g 74.86 25.14 74.58 25.42 74.30 25.70 73.96 26.04 73.74 26.26 73.74 26.26 47 PLE/7HJK. Plaice (7hjk) 7h, 7j and 7k 84.25 15.75 83.71 16.29 83.17 16.83 82.52 17.48 82.09 17.91 82.09 17.91 48 POK/56-14 Saithe (West of Scotland) 6; UK and international waters of 5b, 12 and 14 62.32 37.68 58.99 41.01 55.66 44.34 51.66 48.34 49.00 51.00 49.00 51.00 49 POK/7/3411 Saithe (Celtic Sea) 7, 8, 9 and 10; Union waters of CECAF 34.1.1 84.86 15.14 84.90 15.10 84.93 15.07 84.97 15.03 85.00 15.00 85.00 15.00 50 POL/07. Pollack (7) 7 78.03 21.97 77.27 22.73 76.51 23.49 75.61 24.39 75.00 25.00 75.00 25.00 51 POL/56-14 Pollack (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 63.38 36.62 63.38 36.62 63.38 36.62 63.38 36.62 63.38 36.62 63.38 36.62 52 PRA/2AC4-C Northern Prawn (North Sea) UK and Union waters 4; UK waters of 2a 77.99 22.01 77.99 22.01 77.99 22.01 77.99 22.01 77.99 22.01 77.99 22.01 53 RJE/7FG. Small-eyed Ray (7fg) 7f and 7g 56.36 43.64 53.39 46.61 50.42 49.58 46.86 53.14 44.49 55.51 44.49 55.51 54 RJU/7DE. Undulate Ray (English Channel) 7d and 7e 69.12 30.88 68.09 31.91 67.06 32.94 65.82 34.18 65.00 35.00 65.00 35.00 55 RNG/5B67- Roundnose Grenadier (Western) 6 and 7; UK and international waters of 5b 95.16 4.84 95.16 4.84 95.16 4.84 95.16 4.84 95.16 4.84 95.16 4.84 56 RNG/8X14- Roundnose Grenadier (8,9,10,12,14) 8, 9 and 10; international waters of 12 and 14 99.71 0.29 99.71 0.29 99.71 0.29 99.71 0.29 99.71 0.29 99.71 0.29 57 SAN/2A3A4. Sandeels (North Sea, All Banks) UK and Union waters of 4; UK waters of 2a; Union waters of 3a 97.26 2.74 97.14 2.86 97.03 2.97 96.89 3.11 96.80 3.20 96.80 3.20 58 SBR/678- Red Seabream (Western) 6, 7 and 8 90.00 10.00 90.00 10.00 90.00 10.00 90.00 10.00 90.00 10.00 90.00 10.00 59 SOL/07A. Sole (Irish Sea) 7a 77.15 22.86 77.03 22.97 76.92 23.08 76.79 23.21 76.70 23.30 76.70 23.30 60 SOL/07D. Sole (Eastern Channel) 7d 80.31 19.69 80.23 19.77 80.15 19.85 80.06 19.94 80.00 20.00 80.00 20.00 61 SOL/07E. Sole (Western Channel) 7e 38.97 61.03 38.60 61.40 38.24 61.76 37.79 62.21 37.50 62.50 37.50 62.50 62 SOL/24-C. Sole (North Sea) UK and Union waters 4; UK waters of 2a 88.09 11.91 86.81 13.19 85.54 14.46 84.02 15.98 83.00 17.00 83.00 17.00 63 SOL/56-14 Sole (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 80.00 20.00 80.00 20.00 80.00 20.00 80.00 20.00 80.00 20.00 80.00 20.00 64 SOL/7FG. Sole (7fg) 7f and 7g 69.35 30.65 68.93 31.07 68.51 31.49 68.01 31.99 67.67 32.33 67.67 32.33 65 SOL/7HJK. Sole (7hjk) 7h, 7j and 7k 83.33 16.67 83.33 16.67 83.33 16.67 83.33 16.67 83.33 16.67 83.33 16.67 66 SPR/2AC4-C Sprat (North Sea) UK and Union waters 4; UK waters of 2a 96.18 3.82 96.18 3.82 96.18 3.82 96.18 3.82 96.18 3.82 96.18 3.82 67 SPR/7DE. Sprat (English Channel) 7d and 7e 28.60 71.40 25.45 74.55 22.30 77.70 18.52 81.48 16.00 84.00 16.00 84.00 68 SRX/07D. Skates and Rays (Eastern Channel) 7d 84.51 15.49 84.44 15.56 84.36 15.64 84.27 15.73 84.21 15.79 84.21 15.79 69 SRX/2AC4-C Skates and Rays (North Sea) UK and Union waters 4; UK waters of 2a 32.73 67.27 32.29 67.71 31.86 68.14 31.35 68.65 31.00 69.00 31.00 69.00 70 SRX/67AKXD Skates and Rays (Western) UK and Union waters of 6a, 6b, 7a-c and 7e-k 71.06 28.94 70.54 29.46 70.02 29.98 69.40 30.60 68.99 31.01 68.99 31.01 71 T/B/2AC4-C Turbot and Brill (North Sea)* UK and Union waters of 4; UK waters of 2a 81.82 18.18 81.37 18.63 80.91 19.09 80.36 19.64 80.00 20.00 80.00 20.00 72 USK/04-C. Tusk (North Sea) UK and Union waters of 4 59.46 40.54 59.46 40.54 59.46 40.54 59.46 40.54 59.46 40.54 59.46 40.54 73 USK/567EI. Tusk (Western) 6 and 7; UK and international waters of 5 70.73 29.27 70.55 29.45 70.37 29.63 70.15 29.85 70.00 30.00 70.00 30.00 74 WHG/07A. Whiting (Irish Sea) 7a 42.27 57.73 41.45 58.55 40.63 59.37 39.65 60.35 39.00 61.00 39.00 61.00 75 WHG/56-14 Whiting (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 37.53 62.47 36.67 63.33 35.81 64.19 34.78 65.22 34.09 65.91 34.09 65.91 76 WHG/7X7A-C Whiting (Celtic Sea)* 7b, 7c, 7d, 7e, 7f, 7g, 7h, 7j and 7k 88.95 11.05 88.89 11.11 88.84 11.16 88.77 11.23 88.73 11.27 88.73 11.27 ANNEX 36 A. UK-EU-NO trilateral stocks # Code Common Name ICES Areas Shares 2021 2022 2023 2024 2025 2026 onwards EU UK EU UK EU UK EU UK EU UK EU UK 77 COD/2A3AX4 Cod (North Sea) 4; UK waters of 2a; that part of 3a not covered by the Skagerrak and Kattegat 47.03 52.97 46.02 53.98 45.02 54.99 43.81 56.19 43.00 57.00 43.00 57.00 78 HAD/2AC4. Haddock (North Sea) 4; UK waters of 2a 18.45 81.55 17.80 82.20 17.14 82.86 16.35 83.65 15.83 84.17 15.83 84.17 79 HER/2A47DX Herring (North Sea bycatch) 4 and 7d; UK waters of 2a 98.18 1.82 98.18 1.82 98.18 1.82 98.18 1.82 98.18 1.82 98.18 1.82 80 HER/4AB. Herring (North Sea) UK, Union and Norwegian waters of 4 north of 53\u00b0 30' N 71.33 28.67 70.42 29.58 69.50 30.50 68.41 31.59 67.68 32.32 67.68 32.32 81 HER/4CXB7D Herring (Southern North Sea and Eastern Channel) 4c, 7d excluding Blackwater 88.76 11.24 88.48 11.52 88.21 11.79 87.87 12.13 87.65 12.35 87.65 12.35 82 PLE/2A3AX4 Plaice (North Sea) 4; UK waters of 2a; that part of 3a not covered by the Skagerrak and the Kattegat 71.54 28.46 71.54 28.46 71.54 28.46 71.54 28.46 71.54 28.46 71.54 28.46 83 POK/2C3A4 Saithe (North Sea) 3a and 4; UK waters of 2a 77.71 22.29 76.78 23.22 75.85 24.15 74.74 25.26 74.00 26.00 74.00 26.00 84 WHG/2AC4. Whiting (North Sea) 4; UK waters of 2a 34.78 65.22 32.71 67.29 30.63 69.37 28.13 71.87 26.47 73.53 26.47 73.53 B. Coastal States Stocks # Code Common Name ICES Areas Shares 2021 2022 2023 2024 2025 2026 onwards EU UK EU UK EU UK EU UK EU UK EU UK 85 MAC/2A34. Mackerel (North Sea) 3a and 4; UK waters of 2a; Union waters of 3b, 3c and Subdivisions 22-32 93.91 6.09 93.78 6.22 93.65 6.35 93.50 6.50 93.40 6.60 93.40 6.60 86 MAC/2CX14- Mackerel (Western) 6, 7, 8a, 8b, 8d and 8e; UK and international waters of 5b; international waters of 2a, 12 and 14 35.15 64.85 34.06 65.94 32.98 67.02 31.67 68.33 30.80 69.20 30.80 69.20 87 WHB/1X14 Blue Whiting (Northern) UK, Union and international waters of 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 8d, 8e, 12 and 14 79.47 20.53 79.35 20.65 79.24 20.76 79.09 20.91 79.00 21.00 79.00 21.00 C. ICCAT Stocks # Code Common Name Area Shares EU UK 88 ALB/AN05N Albacore (North Atlantic) Atlantic Ocean, north of 5\u00b0 N 98.48 1.52 89 BFT/AE45WM Bluefin Tuna (Northeast Atlantic) Atlantic Ocean, east of 45\u00b0 W, and Mediterranean 99.75 0.25 90 BSH/AN05N Blue Shark (North Atlantic) Atlantic Ocean, north of 5\u00b0 N 99.90 0.10 91 SWO/AN05N Swordfish (North Atlantic) Atlantic Ocean, North of 5\u00b0 N 99.99 0.01 D. NAFO Stocks # Code Common Name Area Shares EU UK 92 COD/N3M. Cod (NAFO 3M) NAFO 3M 83.66 16.34 E. Special Cases # Code Common Name ICES Areas Shares EU UK 93 COD/1/2B. Cod (Svalbard) 1 and 2b 75.00 25.00 F. Stocks that are only present in one Party's waters # Code Common Name ICES Areas Shares EU UK 94 GHL/2A C46 Greenland Halibut (North Sea and West of Scotland) 6; UK and Union waters of 4; UK waters of 2a; UK and international waters of 5b 27.35 72.65 95 HER/06ACL. Herring (Clyde) 6 Clyde 0.00 100.00 96 HER/1/2- Herring (ASH) UK, Faroese, Norwegian and international waters of 1 and 2 70.00 30.00 97 LIN/05EI. Ling (5) UK and international waters of 5 81.48 18.52 98 LIN/1/2. Ling (1,2) UK and international waters of 1 and 2 77.78 22.22 99 NEP/5BC6. Nephrops (West of Scotland) 6; UK and international waters of 5b 2.36 97.64 100 RED/51214D Redfish [Deep Pelagic] (5,12,14) UK and international waters of 5; international waters of 12 and 14 98.00 2.00 101 RED/51214S Redfish [Shallow Pelagic] (5,12,14) UK and international waters of 5; international waters of 12 and 14 98.00 2.00 102 SBR/10- Red Seabream (Azores) Union and international waters of 10 99.12 0.88 103 SRX/89-C. Skates and Rays (8,9) UK and Union waters of 8; Union waters of 9 99.78 0.22 104 USK/1214EI Tusk (1,2,14) UK and international waters of 1, 2 and 14 71.43 28.57 ANNEX 37 # Stock Code Common Name ICES Areas 105 ANF/8ABDE. Anglerfish (8) 8a, 8b, 8d and 8e 106 BLI/03A- Blue Ling (3a) Union waters of 3a 107 BSF/8910- Black Scabbardfish (8,9,10) 8, 9 and 10 108 COD/03AN. Cod (Skagerrak) Skagerrak 109 HAD/03A. Haddock (3a) 3a 110 HER/03A. Herring (3a) 3a 111 HER/03A-BC Herring (3a bycatch) 3a 112 HER/6AS7BC Herring (West of Ireland) 6aS, 7b and 7c 113 HKE/03A. Hake (3a) 3a 114 HKE/8ABDE. Hake (8) 8a, 8b, 8d and 8e 115 JAX/08C. Horse Mackerel (8c) 8c 116 LEZ/8ABDE. Megrims (8) 8a, 8b, 8d and 8e 117 MAC/2A4A-N Mackerel (Denmark allocation in Norwegian waters) Norwegian waters of 2a and 4a 118 MAC/8C3411 Mackerel (Southern Component) 8c, 9 and 10; Union waters of CECAF 34.1.1 119 PLE/03AN. Plaice (Skagerrak) Skagerrak 120 SPR/03A. Sprat (3a) 3a 121 SRX/03A-C. Skates and Rays (3a) Union waters of 3a 122 USK/03A. Tusk (3a) 3a 123 WHB/8C3411 Blue Whiting (Southern Component) 8c, 9 and 10; Union waters of CECAF 34.1.1 ANNEX 38 PROTOCOL ON ACCESS TO WATERS The United Kingdom and the Union AFFIRMING the sovereign rights and obligations of independent coastal States exercised by the Parties; EMPHASISING that the right of each Party to grant vessels of the other Party access to fish in its waters is ordinarily to be exercised in annual consultations following the determination of TACs for a given year in annual consultations; NOTING the social and economic benefits of a further period of stability, during which fishers would be permitted until 30 June 2026 to continue to access the waters of the other Party as before the entry into force of this Agreement; HAVE AGREED as follows: Article 1 An adjustment period is hereby established. The adjustment period shall last from 1 January 2021 until 30 June 2026. Article 2 1. By way of derogation from Article 500(1), (3), (4), (5), (6) and (7) of this Agreement, during the adjustment period each Party shall grant to vessels of the other Party full access to its waters to fish: (a) stocks listed in Annex 35 and in tables A, B and F of Annex 36 at a level that is reasonably commensurate with the Parties\u2019 respective shares of the fishing opportunities; (b) non quota stocks at a level that equates to the average tonnage fished by that Party in the waters of the other Party during the period 2012-2016; (c) for qualifying vessels to the zone in the waters of the Parties between six and twelve nautical miles from the baselines in ICES divisions 4c and 7d-g to the extent that each Party's qualifying vessels had access to that zone on 31 December 2020. For the purposes point (c), \"qualifying vessel\" means a vessel of a Party, which fished in the zone mentioned in the previous sentence in at least four years between 2012 and 2016, or its direct replacement. 2. The Parties shall notify the other Party of any change in the level and conditions of access to waters that will apply from 1 July 2026. 3. Article 501 of this Agreement shall apply mutatis mutandis in relation to any change under paragraph 2 of this Article in respect of the period from 1 July 2026 to 31 December 2026. ANNEX 39 EXCHANGES OF DNA, FINGERPRINTS AND VEHICLE REGISTRATION DATA CHAPTER 0 GENERAL PROVISIONS Article 1 Aim The aim of this Annex is to lay down the necessary data protection, administrative and technical provisions for the implementation of Title II of Part Three of this Agreement. Article 2 Technical specifications States shall observe common technical specifications in connection with all requests and answers related to searches and comparisons of DNA profiles, dactyloscopic data and vehicle registration data. These technical specifications are laid down in Chapters 1 to 3. Article 3 Communications network The electronic exchange of DNA data, dactyloscopic data and vehicle registration data between States shall take place using the Trans European Services for Telematics between Administrations (TESTA II) communications network and further developments thereof. Article 4 Availability of automated data exchange States shall take all necessary measures to ensure that automated searching or comparison of DNA data, dactyloscopic data and vehicle registration data is possible 24 hours a day and seven days a week. In the event of a technical fault, the States' national contact points shall immediately inform each other and shall agree on temporary alternative information exchange arrangements in accordance with the legal provisions applicable. Automated data exchange shall be re-established as quickly as possible. Article 5 Reference numbers for DNA data and dactyloscopic data The reference numbers referred to in Articles 529 and 533 of this Agreement shall consist of a combination of the following: (a) a code allowing the States, in the case of a match, to retrieve personal data and other information in their databases in order to supply it to one, several or all of the States in accordance with Article 536 of this Agreement; (b) a code to indicate the national origin of the DNA profile or dactyloscopic data; and (c) with respect to DNA data, a code to indicate the type of DNA profile. Article 6 Principles of DNA data exchange 1. States shall use existing standards for DNA data exchange, such as the European Standard Set (ESS) or the Interpol Standard Set of Loci (ISSOL). 2. The transmission procedure, in the case of automated searching and comparison of DNA profiles, shall take place within a decentralised structure. 3. Appropriate measures shall be taken to ensure confidentiality and integrity of data being sent to other States, including their encryption. 4. States shall take the necessary measures to guarantee the integrity of the DNA profiles made available or sent for comparison to the other States and to ensure that those measures comply with international standards such as ISO 17025. 5. States shall use State codes in accordance with the ISO 3166-1 alpha-2 standard. Article 7 Rules for requests and answers in connection with DNA data 1. A request for an automated search or comparison, as referred to in Article 530 or 531 of this Agreement, shall include only the following information: (a) the State code of the requesting State; (b) the date, time and indication number of the request; (c) DNA profiles and their reference numbers; (d) the types of DNA profiles transmitted (unidentified DNA profiles or reference DNA profiles); and (e) information required for controlling the database systems and quality control for the automatic search processes. 2. The answer (matching report) to the request referred to in paragraph 1 shall contain only the following information: (a) an indication as to whether there were one or more matches (HITs) or no matches (No-HITs); (b) the date, time and indication number of the request; (c) the date, time and indication number of the answer; (d) the State codes of the requesting and requested States; (e) the reference numbers of the requesting and requested States; (f) the type of DNA profiles transmitted (unidentified DNA profiles or reference DNA profiles); (g) the requested and matching DNA profiles; and (h) information required for controlling the database systems and quality control for the automatic search processes. 3. Automated notification of a match shall only be provided if the automated search or comparison has resulted in a match of a minimum number of loci. That minimum is set out in Chapter 1. 4. The States shall ensure that requests comply with declarations issued pursuant to Article 529(3) of this Agreement. Article 8 Transmission procedure for automated searching of unidentified DNA profiles in accordance with Article 530 1. If, in a search with an unidentified DNA profile, no match has been found in the national database or a match has been found with an unidentified DNA profile, the unidentified DNA profile may then be transmitted to all other States' databases and if, in a search with this unidentified DNA profile, matches are found with reference DNA profiles and/or unidentified DNA profiles in other States' databases, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting State; if no matches can be found in other States' databases, it shall be automatically communicated to the requesting State. 2. If, in a search with an unidentified DNA profile, a match is found in other States' databases, each State concerned may insert a note to that effect in its national database. Article 9 Transmission procedure for automated search of reference DNA profiles in accordance with Article 530 If, in a search with a reference DNA profile, no match has been found in the national database with a reference DNA profile or a match has been found with an unidentified DNA profile, this reference DNA profile may then be transmitted to all other States' databases and if, in a search with this reference DNA profile, matches are found with reference DNA profiles and/or unidentified DNA profiles in other States' databases, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting State; if no matches can be found in other States' databases, it shall be automatically communicated to the requesting State. Article 10 Transmission procedure for automated comparison of unidentified DNA profiles in accordance with Article 531 1. If, in a comparison with unidentified DNA profiles, matches are found in other States' databases with reference DNA profiles and/or unidentified DNA profiles, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting State. 2. If, in a comparison with unidentified DNA profiles, matches are found in other States' databases with unidentified DNA profiles or reference DNA profiles, each State concerned may insert a note to that effect in its national database. Article 11 Principles for the exchange of dactyloscopic data 1. The digitalisation of dactyloscopic data and their transmission to the other States shall be carried out in accordance with the uniform data format specified in Chapter 2. 2. Each State shall ensure that the dactyloscopic data it transmits are of sufficient quality for a comparison by the automated fingerprint identification systems (AFIS). 3. The transmission procedure for the exchange of dactyloscopic data shall take place within a decentralised structure. 4. Appropriate measures shall be taken to ensure the confidentiality and integrity of dactyloscopic data being sent to other States, including their encryption. 5. The States shall use State codes in accordance with the ISO 3166-1 alpha-2 standard. Article 12 Search capacities for dactyloscopic data 1. Each State shall ensure that its search requests do not exceed the search capacities specified by the requested State. The United Kingdom shall declare their maximum search capacities per day for dactyloscopic data of identified persons and for dactyloscopic data of persons not yet identified. 2. The maximum numbers of candidates accepted for verification per transmission are set out in Chapter 2. Article 13 Rules for requests and answers in connection with dactyloscopic data 1. The requested State shall check the quality of the transmitted dactyloscopic data without delay by a fully automated procedure. Should the data be unsuitable for an automated comparison, the requested State shall inform the requesting State without delay. 2. The requested State shall conduct searches in the order in which requests are received. Requests shall be processed within 24 hours by a fully automated procedure. The requesting State may, if its domestic law so prescribes, ask for accelerated processing of its requests and the requested State shall conduct these searches without delay. If deadlines cannot be met for reasons of force majeure, the comparison shall be carried out without delay as soon as the impediments have been removed. Article 14 Principles of automated searching of vehicle registration data 1. For automated searching of vehicle registration data States shall use a version of the European Vehicle and Driving Licence Information System (Eucaris) software application especially designed for the purposes of Article 537 of this Agreement, and amended versions of that software. 2. Automated searching of vehicle registration data shall take place within a decentralised structure. 3. The information exchanged via the Eucaris system shall be transmitted in encrypted form. 4. The data elements of the vehicle registration data to be exchanged are specified in Chapter 3. 5. In the implementation of Article 537 of this Agreement, States may give priority to searches related to combating serious crime. Article 15 Costs Each State shall bear the costs arising from the administration, use and maintenance of the Eucaris software application referred to in Article 14(1). Article 16 Purpose 1. Processing of personal data by the receiving State shall be permitted solely for the purposes for which the data have been supplied in accordance with Title II of Part Three of this Agreement. Processing for other purposes shall be permitted solely with the prior authorisation of the State administering the file and subject only to the domestic law of the receiving State. Such authorisation may be granted provided that processing for such other purposes is permitted under the domestic law of the State administering the file. 2. Processing of data supplied pursuant to Articles 530, 531 and 534 of this Agreement by the searching or comparing State shall be permitted solely in order to: (a) establish whether the compared DNA profiles or dactyloscopic data match; (b) prepare and submit a police or judicial request for legal assistance in compliance with domestic law if those data match; (c) record within the meaning of Article 19 of this Chapter. 3. The State administering the file may process the data supplied to it in accordance with Articles 530, 531 and 534 of this Agreement solely where this is necessary for the purposes of comparison, providing automated replies to searches or recording pursuant to Article 19 of this Chapter. The supplied data shall be deleted immediately following data comparison or automated replies to searches unless further processing is necessary for the purposes referred to in points (b) and (c) of paragraph 2 of this Article. 4. Data supplied in accordance with Article 537 of this Agreement may be used by the State administering the file solely where this is necessary for the purpose of providing automated replies to search procedures or recording pursuant to Article 19 of this Chapter. The data supplied shall be deleted immediately following automated replies to searches unless further processing is necessary for recording pursuant to Article 19 of this Chapter. The Member State may use data received in a reply solely for the procedure for which the search was made. Article 17 Accuracy, current relevance and storage time of data 1. The States shall ensure the accuracy and current relevance of personal data. The receiving State shall be notified without delay if it transpires ex officio, or from a notification by the data subject, that incorrect data or data which should not have been supplied have been supplied. The State(s) concerned shall be obliged to correct or delete the data. Moreover, personal data supplied shall be corrected if they are found to be incorrect. If the receiving body has reason to believe that the supplied data are incorrect or should be deleted, the supplying body shall be informed forthwith. 2. Data, the accuracy of which the data subject contests and the accuracy or inaccuracy of which cannot be established shall, in accordance with the domestic law of the States, be marked with a flag at the request of the data subject. If a flag exists, this may be removed subject to the domestic law of the States and only with the permission of the data subject or on the basis of a decision of the competent court or independent data protection authority. 3. Personal data supplied which should not have been supplied or received shall be deleted. Data which are lawfully supplied and received shall be deleted: (a) if they are not or no longer necessary for the purpose for which they were supplied; if personal data have been supplied without request, the receiving body shall immediately check if they are necessary for the purposes for which they were supplied; (b) following the expiry of the maximum period for keeping data laid down in the domestic law of the supplying State, where the supplying body informed the receiving body of that maximum period at the time of supplying the data. 4. Where there is reason to believe that deletion would prejudice the interests of the data subject, the data shall be blocked instead of being deleted in compliance with domestic law. Blocked data may be supplied or used solely for the purpose which prevented their deletion. Article 18 Technical and organisational measures to ensure data protection and data security 1. The supplying and receiving bodies shall take steps to ensure that personal data is effectively protected against accidental or unauthorised destruction, accidental loss, unauthorised access, unauthorised or accidental alteration and unauthorised disclosure. 2. The features of the technical specification of the automated search procedure are regulated in the implementing measures as referred to in Article 539 of this Agreement which guarantee that: (a) state-of-the-art technical measures are taken to ensure data protection and data security, in particular data confidentiality and integrity; (b) encryption and authorisation procedures recognised by the competent authorities are used when having recourse to generally accessible networks; and (c) the admissibility of searches in accordance with paragraphs 2, 5 and 6 of Article 19 of this Chapter can be checked. Article 19 Logging and recording: special rules governing automated and non-automated supply 1. Each State shall guarantee that every non-automated supply and every non-automated receipt of personal data by the body administering the file and by the searching body is logged in order to verify the admissibility of the supply. Logging shall contain the following information: (a) the reason for the supply; (b) the data supplied; (c) the date of the supply; and (d) the name or reference code of the searching body and of the body administering the file. 2. The following shall apply to automated searches for data based on Articles 530, 534 and 537 of this Agreement and to automated comparison pursuant to Article 531 of this Agreement: (a) only specially authorised officers of the national contact points may carry out automated searches or comparisons; the list of officers authorised to carry out automated searches or comparisons shall be made available upon request to the supervisory authorities referred to in paragraph 6 and to the other States; (b) each State shall ensure that each supply and receipt of personal data by the body administering the file and the searching body is recorded, including notification of whether or not a HIT exists; recording shall include the following information: (i) the data supplied; (ii) the date and exact time of the supply; and (iii) the name or reference code of the searching body and of the body administering the file. 3. The searching body shall also record the reason for the search or supply as well as an identifier for the official who carried out the search and the official who ordered the search or supply. 4. The recording body shall immediately communicate the recorded data upon request to the competent data protection authorities of the relevant State at the latest within four weeks following receipt of the request; recorded data may be used solely for the following purposes: (a) monitoring data protection; (b) ensuring data security. 5. The recorded data shall be protected with suitable measures against inappropriate use and other forms of improper use and shall be kept for two years. After the conservation period, the recorded data shall be deleted immediately. 6. Responsibility for legal checks on the supply or receipt of personal data lies with the independent data protection authorities or, as appropriate, the judicial authorities of the respective States. Anyone can request those authorities to check the lawfulness of the processing of data in respect of their person in compliance with domestic law. Independently of such requests, those authorities and the bodies responsible for recording shall carry out random checks on the lawfulness of supply, based on the files involved. 7. The results of such checks shall be kept for inspection for 18 months by the independent data protection authorities. After that period, they shall be immediately deleted. Each data protection authority may be requested by the independent data protection authority of another State to exercise its powers in accordance with domestic law. The independent data protection authorities of the States shall perform the inspection tasks necessary for mutual cooperation, in particular by exchanging relevant information. Article 20 Data subjects' rights to damages Where a body of one State has supplied personal data under Title II of Part Three of this Agreement, the receiving body of the other State cannot use the inaccuracy of the data supplied as grounds to evade its liability vis-\u00e0-vis the injured party under domestic law. If damages are awarded against the receiving body because of its use of inaccurate transfer data, the body which supplied the data shall refund the amount paid in damages to the receiving body in full. Article 21 Information requested by the States The receiving State shall inform the supplying State on request of the processing of supplied data and the result obtained. Article 22 Declarations and designations 1. The United Kingdom shall communicate its declarations pursuant to Article 529(3) of this Agreement, and Article 12(1) of this Chapter, as well as its designations pursuant to Articles 535(1) and 537(3) of this Agreement to the Specialised Committee on Law Enforcement and Judicial Cooperation. 2. Factual information provided by the United Kingdom through these declarations and designations, and by Member States in accordance with Article 539(3) of this Agreement, are included in the Manual as referred to in Article 18(2) of Decision 2008/616/JHA. 3. States may amend declarations and designations submitted in accordance with paragraph 1 at any time by means of a notification submitted to the Specialised Committee on Law Enforcement and Judicial Cooperation. The Specialised Committee on Law Enforcement and Judicial Cooperation shall forward any declarations received to the General Secretariat of the Council. 4. The General Secretariat of the Council shall communicate any changes in the Manual referred to in paragraph 2 to the Specialised Committee on Law Enforcement and Judicial Cooperation. Article 23 Preparation of decisions as referred to in Article 540 1. The Council shall take a decision as referred to in Article 540 of this Agreement on the basis of an evaluation report which shall be based on a questionnaire. 2. With respect to the automated data exchange in accordance with Title II of Part Three of this Agreement, the evaluation report shall also be based on an evaluation visit and a pilot run that shall be carried out if required when the United Kingdom has informed the Specialised Committee on Law Enforcement and Judicial Cooperation that they have implemented the obligations imposed on them under Title II of Part Three of this Agreement and submit the declarations provided for in Article 22 of this Chapter. Further details of the procedure are set out in Chapter 4 of this Annex. Article 24 Statistics and reporting 1. An evaluation of the administrative, technical and financial application of the data exchange pursuant to Title II of Part Three of this Agreement shall be carried out on a regular basis. The evaluation shall be carried out with respect to the data categories for which data exchange has started among the States concerned. The evaluation shall be based on reports of the respective States. 2. Each State shall compile statistics on the results of the automated data exchange. In order to ensure comparability, the model for statistics will be compiled by the relevant Council Working Group. These statistics will be forwarded annually to the Specialised Committee on Law Enforcement and Judicial Cooperation. 3. In addition, States will be requested on a regular basis not to exceed once per year to provide further information on the administrative, technical and financial implementation of automated data exchange as needed to analyse and improve the process. 4. Statistics and reporting made by Member States in accordance with Decisions 2008/615/JHA and 2008/616/JHA shall apply in relation to this Article. CHAPTER 1 EXCHANGE OF DNA-DATA 1. DNA related forensic issues, matching rules and algorithms 1.1. Properties of DNA-profiles The DNA profile may contain 24 pairs of numbers representing the alleles of 24 loci which are also used in the DNA-procedures of Interpol. The names of those loci are provided in the following table: VWA TH01 D21S11 FGA D8S1179 D3S1358 D18S51 Amelogenin TPOX CSF1P0 D13S317 D7S820 D5S818 D16S539 D2S1338 D19S433 Penta D Penta E FES F13A1 F13B SE33 CD4 GABA The seven grey loci in the top row are both the present ESS and the ISSOL. Inclusion Rules: The DNA-profiles made available by the States for searching and comparison as well as the DNA-profiles sent out for searching and comparison shall contain at least six full designated (1) loci and may contain additional loci or blanks depending on their availability. The reference DNA profiles shall contain at least six of the seven ESS of loci. In order to raise the accuracy of matches, all available alleles shall be stored in the indexed DNA profile database and be used for searching and comparison. Each State should implement as soon as practically possible any new ESS of loci adopted by the EU. Mixed profiles are not allowed, so that the allele values of each locus will consist of only two numbers, which may be the same in the case of homozygosity at a given locus. Wild-cards and Micro-variants are to be dealt with using the following rules: \u2014 Any non-numerical value except amelogenin contained in the profile (e.g. \"o\", \"f\", \"r\", \"na\", \"nr\" or \"un\") has to be automatically converted for the export to a wild card (*) and searched against all, \u2014 Numerical values \"0\", \"1\" or \"99\" contained in the profile have to be automatically converted for the export to a wild card (*) and searched against all, \u2014 If three alleles are provided for one locus the first allele will be accepted and the remaining two alleles have to be automatically converted for the export to a wild card (*) and searched against all, \u2014 When wild card values are provided for allele 1 or 2 then both permutations of the numerical value given for the locus will be searched (e.g. 12, * could match against 12,14 or 9,12), \u2014 Pentanucleotide (Penta D, Penta E and CD4) micro-variants will be matched according to the following: \u2014 x.1 = x, x.1, x.2 \u2014 x.2 = x.1, x.2, x.3 \u2014 x.3 = x.2, x.3, x.4 \u2014 x.4 = x.3, x.4, x + 1, \u2014 Tetranucleotide (the rest of the loci are tetranucleotides) micro-variants will be matched according to the following: \u2014 x.1 = x, x.1, x.2 \u2014 x.2 = x.1, x.2, x.3 \u2014 x.3 = x.2, x.3, x + 1. 1.2. Matching rules The comparison of two DNA-profiles will be performed on the basis of the loci for which a pair of allele values is available in both DNA-profiles. At least six full designated loci (exclusive of amelogenin) must match between both DNA-profiles before a HIT response is provided. A full match (Quality 1) is defined as a match, when all allele values of the compared loci commonly contained in the requesting and requested DNA-profiles are the same. A near match is defined as a match, when the value of only one of all the compared alleles is different in the two DNA profiles (Quality 2, 3 and 4). A near match is only accepted if there are at least six full designated matched loci in the two compared DNA profiles. The reason for a near match may be: \u2014 a human typing error at the point of entry of one of the DNA-profiles in the search request or the DNA-database, \u2014 an allele-determination or allele-calling error during the generation procedure of the DNA-profile. 1.3. Reporting rules Full matches, near matches and \"No-HITs\" will all be reported. The matching report will be sent to the requesting national contact point and will also be made available to the requested national contact point (to enable it to estimate the nature and number of possible follow-up requests for further available personal data and other information associated with the DNA-profile corresponding to the HIT in accordance with Article 536 of this Agreement. 2. State code number table In accordance with Title II of Part Three of this Agreement, ISO 3166-1 alpha-2 code are used for setting up the domain names and other configuration parameters required in the Pr\u00fcm DNA data exchange applications over a closed network. ISO 3166-1 alpha-2 codes are the following two-letter State codes: State names Code State names Code Belgium BE Lithuania LT Bulgaria BG Luxemburg LU Czech Republic CZ Hungary HU Denmark DK Malta MT Germany DE Netherlands NL Estonia EE Austria AT Ireland IE Poland PL Greece EL Portugal PT Spain ES Romania RO France FR Slovakia SK Croatia HR Slovenia SI Italy IT Finland FI Cyprus CY Sweden SE Latvia LV United Kingdom UK 3. Functional analysis 3.1. Availability of the system Requests pursuant to Article 530 of this Agreement should reach the targeted database in the chronological order that each request was sent; responses should be dispatched to reach the requesting State within 15 minutes of the arrival of requests. 3.2. Second step When a State receives a report of a match, its national contact point is responsible for comparing the values of the profile submitted as a question and the values of the profile(s) received as an answer to validate and check the evidential value of the profile. National contact points can contact each other directly for validation purposes. Legal assistance procedures start after validation of an existing match between two profiles, on the basis of a \"full match\" or a \"near match\" obtained during the automated consultation phase. 4. DNA interface control document 4.1. Introduction 4.1.1. Objectives This Chapter defines the requirements for the exchange of DNA profile information between the DNA database systems of all States. The header fields are defined specifically for the Pr\u00fcm DNA exchange; the data part is based on the DNA profile data part in the XML schema defined for the Interpol DNA exchange gateway. Data are exchanged by Simple Mail Transfer Protocol (SMTP) and other state-of-the-art technologies, using a central relay mail server provided by the network provider. The XML file is transported as mail body. 4.1.2. Scope This ICD defines the content of the message (or \"mail\") only. All network-specific and mail-specific topics are defined uniformly in order to allow a common technical base for the DNA data exchange. This includes: \u2014 the format of the subject field in the message to enable/allow for an automated processing of the messages, \u2014 whether content encryption is necessary and if yes which methods should be chosen, \u2014 the maximum length of messages. 4.1.3. XML structure and principles The XML message is structured into: \u2014 the header part, which contains information about the transmission, and \u2014 the data part, which contains profile specific information, as well as the profile itself. The same XML schema shall be used for request and response. For the purpose of complete checks of unidentified DNA profiles, as provided for in Article 531 of this Agreement, it shall be possible to send a batch of profiles in one message. A maximum number of profiles within one message must be defined. The number depends on the maximum allowed mail size and shall be defined after selection of the mail server. XML example: <?version=\"1.0\" standalone=\"yes\"?> <PRUEMDNAx xmlns:msxsl=\"urn:schemas-microsoft-com:xslt\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\"> <header> (\u2026) </header> <datas> (\u2026) </datas> [<datas> datas structure repeated, if multiple profiles sent by (\u2026) a single SMTP message, only allowed for Article 531 of this Agreement cases </datas>] </PRUEMDNA> 4.2. XML structure definition The following definitions are for documentation purposes and better readability; the real binding information is provided by an XML schema file (PRUEM DNA.xsd). 4.2.1. Schema PRUEMDNAx It contains the following fields: Fields Type Description header PRUEM_header Occurs: 1 datas PRUEM_datas Occurs: 1 \u2026 500 4.2.2. Content of header structure 4.2.2.1. PRUEM header This is a structure describing the XML file header. It contains the following fields: Fields Type Description direction PRUEM_header_dir Direction of message flow ref String Reference of the XML file generator String Generator of XML file schema_version String Version number of schema to use requesting PRUEM_header_info Requesting State info requested PRUEM_header_info Requested State info 4.2.2.2. PRUEM_header dir Type of data contained in message, value can be: Value Description R Request A Answer 4.2.2.3. PRUEM header info Structure to describe State as well as message date/time. It contains the following fields: Fields Type Description source_isocode String ISO 3166-2 code of the requesting State destination_isocode String ISO 3166-2 code of the requested State request_id String unique Identifier for a request date Date Date of creation of message time Time Time of creation of message 4.2.3. Content of PRUEM Profile data 4.2.3.1. PRUEM_datas This is a structure describing the XML profile data part. It contains the following fields: Fields Type Description reqtype PRUEM request type Type of request (Article 530 or 531) date Date Date profile stored type PRUEM_datas_type Type of profile result PRUEM_datas_result Result of request agency String Name of corresponding unit responsible for the profile profile_ident String Unique State profile ID message String Error Message, if result = E profile IPSG_DNA_profile If direction = A (Answer) AND result \u2260 H (HIT) empty match_id String In case of a HIT PROFILE_ID of the requesting profile quality PRUEM_hitquality_type Quality of HIT hitcount Integer Count of matched Alleles rescount Integer Count of matched profiles. If direction = R (Request), then empty. If quality!=0 (the original requested profile), then empty. 4.2.3.2. PRUEM_request_type Type of data contained in message, value can be: Value Description 3 Requests pursuant to Article 530 4 Requests pursuant to Article 531 4.2.3.3. PRUEM_hitquality_type Value Description 0 Referring original requesting profile: Case \"No-HIT\": original requesting profile sent back only; Case \"HIT\": original requesting profile and matched profiles sent back. 1 Equal in all available alleles without wildcards 2 Equal in all available alleles with wildcards 3 HIT with Deviation (Microvariant) 4 HIT with mismatch 4.2.3.4. PRUEM_data_type Type of data contained in message, value can be: Value Description P Person profile S Stain 4.2.3.5. PRUEM_data_result Type of data contained in message, value can be: Value Description U Undefined, If direction = R (request) H HIT N No-HIT E Error 4.2.3.6. IPSG_DNA_profile Structure describing a DNA profile. It contains the following fields: Fields Type Description ess_issol IPSG_DNA_ISSOL Group of loci corresponding to the ISSOL (standard group of Loci of Interpol) additional_loci IPSG_DNA_additional_loci Other loci marker String Method used to generate of DNA profile_id String Unique identifier for DNA profile 4.2.3.7. IPSG_DNA_ISSOL Structure containing the loci of ISSOL (Standard Group of Interpol loci). It contains the following fields: Fields Type Description vwa IPSG_DNA_locus Locus vwa th01 IPSG_DNA_locus Locus th01 d21s11 IPSG_DNA_locus Locus d21s11 fga IPSG_DNA_locus Locus fga d8s1179 IPSG_DNA_locus Locus d8s1179 d3s1358 IPSG_DNA_locus Locus d3s1358 d18s51 IPSG_DNA_locus Locus d18s51 amelogenin IPSG_DNA_locus Locus amelogin 4.2.3.8. IPSG_DNA_additional_loci Structure containing the other loci. It contains the following fields: Fields Type Description tpox IPSG_DNA_locus Locus tpox csf1po IPSG_DNA_locus Locus csf1po d13s317 IPSG_DNA_locus Locus d13s317 d7s820 IPSG_DNA_locus Locus d7s820 d5s818 IPSG_DNA_locus Locus d5s818 d16s539 IPSG_DNA_locus Locus d16s539 d2s1338 IPSG_DNA_locus Locus d2s1338 d19s433 IPSG_DNA_locus Locus d19s433 penta_d IPSG_DNA_locus Locus penta_d penta_e IPSG_DNA_locus Locus penta_e fes IPSG_DNA_locus Locus fes f13a1 IPSG_DNA_locus Locus f13a1 f13b IPSG_DNA_locus Locus f13b se33 IPSG_DNA_locus Locus se33 cd4 IPSG_DNA_locus Locus cd4 gaba IPSG_DNA_locus Locus gaba 4.2.3.9. IPSG_DNA_locus Structure describing a locus. It contains the following fields: Fields Type Description low_allele String Lowest value of an allele high_allele String Highest value of an allele 5. Application, security and communication architecture 5.1. Overview In implementing applications for the DNA data exchange within the framework of Title II of Part Three of this Agreement, a common communication network shall be used, which will be logically closed among the States. In order to exploit this common communication infrastructure of sending requests and receiving replies in a more effective way, an asynchronous mechanism to convey DNA and dactyloscopic data requests in a wrapped SMTP e-mail message is adopted. In fulfilment of security concerns, the mechanism s/MIME as extension to the SMTP functionality will be used to establish a true end-to-end secure tunnel over the network. The operational Trans European Services for Telematics between Administrations (TESTA) is used as the communication network for data exchange among the States. TESTA is under the responsibility of the European Commission. Taking into account that national DNA databases and the current national access points of TESTA may be located on different sites in the States, access to TESTA may be set up either by: 1. using the existing national access point or establishing a new national TESTA access point; or 2. setting up a secure local link from the site where the DNA database is located and managed by the competent national agency to the existing national TESTA access point. The protocols and standards deployed in the implementation of Title II of Part Three of this Agreement applications comply with the open standards and meet the requirements imposed by national security policy makers of the States. 5.2. Upper Level Architecture In the scope of Title II of Part Three of this Agreement, each State will make its DNA data available to be exchanged with and/or searched by other States in conformity with the standardised common data format. The architecture is based upon an any-to-any communication model. There exists neither a central computer server nor a centralised database to hold DNA profiles. In addition to the fulfilment of domestic legal constraints at States' sites, each State may decide what kind of hardware and software should be deployed for the configuration at its site to comply with the requirements set out in Title II of Part Three of this Agreement. 5.3. Security Standards and Data Protection Three levels of security concerns have been considered and implemented. 5.3.1. Data Level DNA profile data provided by each State shall have to be prepared in compliance with a common data protection standard, so that requesting States will receive an answer mainly to indicate HIT or No-HIT along with an identification number in case of a HIT, which does not contain any personal information. The further investigation after the notification of a HIT will be conducted at bilateral level pursuant to the existing domestic legal and organisational regulations of the respective States' sites. 5.3.2. Communication Level Messages containing DNA profile information (requesting and replying) will be encrypted by means of a state-of-the-art mechanism in conformity with open standards, such as s/MIME, before they are forwarded to the sites of other States. 5.3.3. Transmission Level All encrypted messages containing DNA profile information will be forwarded onto other States' sites through a virtual private tunnelling system administered by a trusted network provider at the international level and the secure links to this tunnelling system under national responsibility. This virtual private tunnelling system does not have a connection point with the open Internet. 5.4. Protocols and Standards to be used for encryption mechanism: s/MIME and related packages The open standard s/MIME as extension to de facto e-mail standard SMTP will be deployed to encrypt messages containing DNA profile information. The protocol s/MIME (V3) allows signed receipts, security labels, and secure mailing lists and is layered on Cryptographic Message Syntax (CMS), an Internet Engineering Task Force (IETF) specification for cryptographic protected messages. It can be used to digitally sign, digest, authenticate or encrypt any form of digital data. The underlying certificate used by the s/MIME mechanism has to be in compliance with X.509 standard. In order to ensure common standards and procedures with other Pr\u00fcm applications, the processing rules for s/MIME encryption operations or to be applied under various Commercial Product of the Shelves (COTS) environments, are as follows: \u2014 the sequence of the operations is: first encryption and then signing, \u2014 the encryption algorithm AES (Advanced Encryption Standard) with 256 bit key length and RSA with 1024 bit key length shall be applied for symmetric and asymmetric encryption respectively, \u2014 the hash algorithm SHA-1 shall be applied. s/MIME functionality is built into the vast majority of modern e-mail software packages including Outlook, Mozilla Mail as well as Netscape Communicator 4.x and inter-operates among all major e-mail software packages. Because of s/MIME's easy integration into national IT infrastructure at all States' sites, it is selected as a viable mechanism to implement the communication security level. For achieving the goal \"Proof of Concept\" in a more efficient way and reducing costs the open standard JavaMail API is however chosen for prototyping DNA data exchange. JavaMail API provides simple encryption and decryption of e-mails using s/MIME and/or OpenPGP. The intent is to provide a single, easy-to-use API for e-mail clients that want to send and receive encrypted e-mail in either of the two most popular e-mail encryption formats. Therefore any state-of-the-art implementations to JavaMail API will suffice for the requirements set by Title II of Part Three of this Agreement, such as the product of Bouncy Castle JCE (Java Cryptographic Extension), which will be used to implement s/MIME for prototyping DNA data exchange among all States. 5.5. Application Architecture Each State will provide the other States with a set of standardised DNA profile data which are in conformity with the current common ICD. This can be done either by providing a logical view over individual national database or by establishing a physical exported database (indexed database). The four main components: E-mail server/s/MIME, Application Server, Data Structure Area for fetching/feeding data and registering incoming/outgoing messages, and Match Engine implement the whole application logic in a product-independent way. In order to provide all States with an easy integration of the components into their respective national sites, the specified common functionality has been implemented by means of open source components, which could be selected by each State depending on its national IT policy and regulations. Because of the independent features to be implemented to get access to indexed databases containing DNA profiles covered by Title II of Part Three of this Agreement, each State can freely select its hardware and software platform, including database and operating systems. A prototype for the DNA Data Exchange has been developed and successfully tested over the existing common network. The version 1.0 has been deployed in the productive environment and is used for daily operations. States may use the jointly developed product but may also develop their own products. The common product components will be maintained, customised and further developed according to changing IT, forensic and/or functional police requirements. 5.6. Protocols and Standards to be used for application architecture: 5.6.1. XML The DNA data exchange will fully exploit XML-schema as attachment to SMTP e-mail messages. The eXtensible Markup Language (XML) is a W3C-recommended general-purpose markup language for creating special-purpose markup languages, capable of describing many different kinds of data. The description of the DNA profile suitable for exchange among all States has been done by means of XML and XML schema in the ICD document. 5.6.2. ODBC Open DataBase Connectivity provides a standard software API method for accessing database management systems and making it independent of programming languages, database and operating systems. ODBC has, however, certain drawbacks. Administering a large number of client machines can involve a diversity of drivers and DLLs. This complexity can increase system administration overhead. 5.6.3. JDBC Java DataBase Connectivity (JDBC) is an API for the Java programming language that defines how a client may access a database. In contrast to ODBC, JDBC does not require to use a certain set of local DLLs at the Desktop. The business logic of processing DNA profile requests and replies at each States' site is described in the following diagram. Both requesting and replying flows interact with a neutral data area comprising different data pools with a common data structure. 5.7. Communication Environment 5.7.1. Common Communication Network: TESTA and its follow-up infrastructure The application DNA data exchange will exploit the e-mail, an asynchronous mechanism, to send requests and to receive replies among the States. As all States have at least one national access point to the TESTA network, the DNA data exchange will be deployed over the TESTA network. TESTA provides a number of added-value services through its e-mail relay. In addition to hosting TESTA specific e-mail boxes, the infrastructure can implement mail distribution lists and routing policies. This allows TESTA to be used as a clearing house for messages addressed to administrations connected to the EU wide Domains. Virus check mechanisms may also be put in place. The TESTA e-mail relay is built on a high availability hardware platform located at the central TESTA application facilities and protected by firewall. The TESTA Domain Name Systems (DNS) will resolve resource locators to IP addresses and hide addressing issues from the user and from applications. 5.7.2. Security Concern The concept of a Virtual Private Network (VPN) has been implemented within the framework of TESTA. Tag Switching Technology used to build this VPN will evolve to support Multi-Protocol Label Switching (MPLS) standard developed by the IETF. MPLS is an IETF standard technology that speeds up network traffic flow by avoiding packet analysis by intermediate routers (hops). This is done on the basis of so-called labels that are attached to packet by the edge routers of the backbone, on the basis of information stored in the forwarding information base (FIB). Labels are also used to implement VPNs. MPLS combines the benefits of layer 3 routing with the advantages of layer 2 switching. Because IP addresses are not evaluated during transition through the backbone, MPLS does not impose any IP addressing limitations. Furthermore, e-mail messages over the TESTA will be protected by s/MIME driven encryption mechanism. Without knowing the key and possessing the right certificate, nobody can decrypt messages over the network. 5.7.3. Protocols and Standards to be used over the communication network 5.7.3.1. SMTP SMTP is the de facto standard for e-mail transmission across the Internet. SMTP is a relatively simple, text-based protocol, where one or more recipients of a message are specified and then the message text is transferred. SMTP uses TCP port 25 upon the specification by the IETF. To determine the SMTP server for a given domain name, the MX (Mail eXchange) DNS (Domain Name Systems) record is used. Since this protocol started as purely ASCII text-based it did not deal well with binary files. Standards such as MIME were developed to encode binary files for transfer through SMTP. Today, most SMTP servers support the 8BITMIME and s/MIME extension, permitting binary files to be transmitted almost as easily as plain text. The processing rules for s/MIME operations are described in the section s/MIME (see Section 5.4). SMTP is a \"push\" protocol that does not allow one to \"pull\" messages from a remote server on demand. To do this a mail client shall use POP3 or IMAP. Within the framework of implementing DNA data exchange it is decided to use the protocol POP3. 5.7.3.2. POP Local e-mail clients use the Post Office Protocol version 3 (POP3), an application-layer Internet standard protocol, to retrieve e-mail from a remote server over a TCP/IP connection. By using the SMTP Submit profile of the SMTP protocol, e-mail clients send messages across the Internet or over a corporate network. MIME serves as the standard for attachments and non-ASCII text in e-mail. Although neither POP3 nor SMTP requires MIME-formatted e-mail, essentially Internet e-mail comes MIME-formatted, so POP clients must also understand and use MIME. The whole communication environment of Title II of Part Three of this Agreement will therefore include the components of POP. 5.7.4. Network Address Assignment Operative environment A dedicated block half B class subnet has currently been allocated by the European IP registration authority (RIPE) to TESTA. The assignment of IP addresses to States is based upon a geographical schema in Europe. The data exchange among States within the framework of Title II of Part Three of this Agreement is operated over a European wide logically closed IP network. Testing Environment In order to provide a smooth running environment for the daily operation among all connected States, it is necessary to establish a testing environment over the closed network for new States which prepare to join the operations. A sheet of parameters including IP addresses, network settings, e-mail domains as well as application user accounts has been specified and should be set up at the corresponding State's site. Moreover, a set of pseudo DNA profiles has been constructed for test purposes. 5.7.5. Configuration Parameters A secure e-mail system is set up using the eu-admin.net domain. That domain with the associated addresses will not be accessible from a location not on the TESTA EU wide domain, because the names are only known on the TESTA central DNS server, which is shielded from the Internet. The mapping of these TESTA site addresses (host names) to their IP addresses is done by the TESTA DNS service. For each Local Domain, a Mail entry will be added to this TESTA central DNS server, relaying all e-mail messages sent to TESTA Local Domains to the TESTA central Mail Relay. That TESTA central Mail Relay will then forward them to the specific Local Domain e-mail server using the Local Domain e-mail addresses. By relaying the e-mail in this way, critical information contained in e-mails will only pass the Europe-wide closed network infrastructure and not the insecure Internet. It is necessary to establish sub-domains (bold italics) at the sites of all States upon the following syntax: \"application-type.State-code.pruem.testa.eu\", where: \"State-code\" takes the value of one of the two letter-code State codes (i.e. AT, BE, etc.); \"application-type\" takes one of the values: DNA, FP and CAR. By applying the above syntax, the sub domains for the States are shown in the following table: States' sub domains syntax State Sub Domains Comments BE dna.be.pruem.testa.eu fp.be.pruem.testa.eu car.be.pruem.testa.eu test.dna.be.pruem.testa.eu test.fp.be.pruem.testa.eu test.car.be.pruem.testa.eu BG dna.bg.pruem.testa.eu fp.bg.pruem.testa.eu car.bg.pruem.testa.eu test.dna.bg.pruem.testa.eu test.fp.bg.pruem.testa.eu test.car.bg.pruem.testa.eu CZ dna.cz.pruem.testa.eu fp.cz.pruem.testa.eu car.cz.pruem.testa.eu test.dna.cz.pruem.testa.eu test.fp.cz.pruem.testa.eu test.car.cz.pruem.testa.eu DK dna.dk.pruem.testa.eu fp.dk.pruem.testa.eu car.dk.pruem.testa.eu test.dna.dk.pruem.testa.eu test.fp.dk.pruem.testa.eu test.car.dk.pruem.testa.eu DE dna.de.pruem.testa.eu fp.de.pruem.testa.eu car.de.pruem.testa.eu test.dna.de.pruem.testa.eu test.fp.de.pruem.testa.eu test.car.de.pruem.testa.eu EE dna.ee.pruem.testa.eu fp.ee.pruem.testa.eu car.ee.pruem.testa.eu test.dna.ee.pruem.testa.eu test.fp.ee.pruem.testa.eu test.car.ee.pruem.testa.eu IE dna.ie.pruem.testa.eu fp.ie.pruem.testa.eu car.ie.pruem.testa.eu test.dna.ie.pruem.testa.eu test.fp.ie.pruem.testa.eu test.car.ie.pruem.testa.eu EL dna.el.pruem.testa.eu fp.el.pruem.testa.eu car.el.pruem.testa.eu test.dna.el.pruem.testa.eu test.fp.el.pruem.testa.eu test.car.el.pruem.testa.eu ES dna.es.pruem.testa.eu fp.es.pruem.testa.eu car.es.pruem.testa.eu test.dna.es.pruem.testa.eu test.fp.es.pruem.testa.eu test.car.es.pruem.testa.eu FR dna.fr.pruem.testa.eu fp.fr.pruem.testa.eu car.fr.pruem.testa.eu test.dna.fr.pruem.testa.eu test.fp.fr.pruem.testa.eu test.car.fr.pruem.testa.eu HR dna.hr.pruem.testa.eu fp.hr.pruem.testa.eu car.hr.pruem.testa.eu test.dna.hr.pruem.testa.eu test.fp.hr.pruem.testa.eu test.car.hr.pruem.testa.eu IT dna.it.pruem.testa.eu fp.it.pruem.testa.eu car.it.pruem.testa.eu test.dna.it.pruem.testa.eu test.fp.it.pruem.testa.eu test.car.it.pruem.testa.eu CY dna.cy.pruem.testa.eu fp.cy.pruem.testa.eu car.cy.pruem.testa.eu test.dna.cy.pruem.testa.eu test.fp.cy.pruem.testa.eu test.car.cy.pruem.testa.eu LV dna.lv.pruem.testa.eu fp.lv.pruem.testa.eu car.lv.pruem.testa.eu test.dna.lv.pruem.testa.eu test.fp.lv.pruem.testa.eu test.car.lv.pruem.testa.eu LT dna.lt.pruem.testa.eu fp.lt.pruem.testa.eu car.lt.pruem.testa.eu test.dna.lt.pruem.testa.eu test.fp.lt.pruem.testa.eu test.car.lt.pruem.testa.eu LU dna.lu.pruem.testa.eu fp.lu.pruem.testa.eu car.lu.pruem.testa.eu test.dna.lu.pruem.testa.eu test.fp.lu.pruem.testa.eu test.car.lu.pruem.testa.eu HU dna.hu.pruem.testa.eu fp.hu.pruem.testa.eu car.hu.pruem.testa.eu test.dna.hu.pruem.testa.eu test.fp.hu.pruem.testa.eu test.car.hu.pruem.testa.eu MT dna.mt.pruem.testa.eu fp.mt.pruem.testa.eu car.mt.pruem.testa.eu test.dna.mt.pruem.testa.eu test.fp.mt.pruem.testa.eu test.car.mt.pruem.testa.eu NL dna.nl.pruem.nl.testa.eu fp.nl.pruem.testa.eu car.nl.pruem.testa.eu test.dna.nl.pruem.testa.eu test.fp.nl.pruem.testa.eu test.car.nl.pruem.testa.eu AT dna.at.pruem.testa.eu fp.at.pruem.testa.eu car.at.pruem.testa.eu test.dna.at.pruem.testa.eu test.fp.at.pruem.testa.eu test.car.at.pruem.testa.eu PL dna.pl.pruem.testa.eu fp.pl.pruem.testa.eu car.pl.pruem.testa.eu test.dna.pl.pruem.testa.eu test.fp.pl.pruem.testa.eu test.car.pl.pruem.testa.eu PT dna.pt.pruem.testa.eu fp.pt.pruem.testa.eu car.pt.pruem.testa.eu test.dna.pt.pruem.testa.eu test.fp.pt.pruem.testa.eu test.car.pt.pruem.testa.eu RO dna.ro.pruem.testa.eu fp.ro.pruem.testa.eu car.ro.pruem.testa.eu test.dna.ro.pruem.testa.eu test.fp.ro.pruem.testa.eu test.car.ro.pruem.testa.eu SI dna.si.pruem.testa.eu fp.si.pruem.testa.eu car.si.pruem.testa.eu test.dna.si.pruem.testa.eu test.fp.si.pruem.testa.eu test.car.si.pruem.testa.eu SK dna.sk.pruem.testa.eu fp.sk.pruem.testa.eu car.sk.pruem.testa.eu test.dna.sk.pruem.testa.eu test.fp.sk.pruem.testa.eu test.car.sk.pruem.testa.eu FI dna.fi.pruem.testa.eu fp.fi.pruem.testa.eu car.fi.pruem.testa.eu test.dna.fi.pruem.testa.eu test.fp.fi.pruem.testa.eu test.car.fi.pruem.testa.eu SE dna.se.pruem.testa.eu fp.se.pruem.testa.eu car.se.pruem.testa.eu test.dna.se.pruem.testa.eu test.fp.se.pruem.testa.eu test.car.se.pruem.testa.eu UK dna.uk.pruem.testa.eu fp.uk.pruem.testa.eu car.uk.pruem.testa.eu test.dna.uk.pruem.testa.eu test.fp.uk.pruem.testa.eu test.car.uk.pruem.testa.eu CHAPTER 2 EXCHANGE OF DACTYLOSCOPIC DATA (INTERFACE CONTROL DOCUMENT) The purpose of the following document interface Control Document is to define the requirements for the exchange of dactyloscopic information between the Automated Fingerprint Identification Systems (AFIS) of the States. It is based on the Interpol-Implementation of ANSI/NIST-ITL 1-2000 (INT-I, Version 4.22b). This version shall cover all basic definitions for Logical Records Type-1, Type-2, Type-4, Type-9, Type-13 and Type-15 required for image- and minuti\u00e6-based dactyloscopic processing. 1. File Content Overview A dactyloscopic file consists of several logical records. There are sixteen types of record specified in the original ANSI/NIST-ITL 1-2000 standard. Appropriate ASCII separation characters are used between each record and the fields and subfields within the records. Only 6 record types are used to exchange information between the originating and the destination agency: Type-1 \u2192 Transaction information Type-2 \u2192 Alphanumeric persons/case data Type-4 \u2192 High resolution greyscale dactyloscopic images Type-9 \u2192 Minuti\u00e6 Record Type-13 \u2192 Variable resolution latent image record Type-15 \u2192 Variable resolution palmprint image record 1.1. Type-1 \u2014 File header This record contains routing information and information describing the structure of the rest of the file. This record type also defines the types of transaction which fall under the following broad categories: 1.2. Type-2 \u2014 Descriptive text This record contains textual information of interest to the sending and receiving agencies. 1.3. Type-4 \u2014 High resolution greyscale image This record is used to exchange high resolution greyscale (eight bit) dactyloscopic images sampled at 500 pixels/inch. The dactyloscopic images shall be compressed using the WSQ algorithm with a ratio of not more than 15:1. Other compression algorithms or uncompressed images shall not be used. 1.4. Type-9 \u2014 Minuti\u00e6 record Type-9 records are used to exchange ridge characteristics or minuti\u00e6 data. Their purpose is partly to avoid unnecessary duplication of AFIS encoding processes and partly to allow the transmission of AFIS codes which contain less data than the corresponding images. 1.5. Type-13 \u2014 Variable-Resolution Latent Image Record This record shall be used to exchange variable-resolution latent fingerprint and latent palmprint images together with textural alphanumerical information. The scanning resolution of the images shall be 500 pixels/inch with 256 grey-levels. If the quality of the latent image is sufficient it shall be compressed using WSQ-algorithm. If necessary the resolution of the images may be expanded to more than 500 pixels/inch and more than 256 grey-levels by mutual agreement. In that case, it is strongly recommended to use JPEG 2000 (see Appendix 39-7). 1.6. Variable-Resolution Palmprint Image Record Type-15 tagged field image records shall be used to exchange variable-resolution palmprint images together with textural alphanumerical information. The scanning resolution of the images shall be 500 pixels/inch with 256 grey-levels. To minimise the amount of data, all palmprint images shall be compressed using WSQ-algorithm. If necessary the resolution of the images may be expanded to more than 500 pixels/inch and more than 256 grey-levels by mutual agreement. In that case, it is strongly recommended to use JPEG 2000 (see Appendix 39-7). 2. Record format A transaction file shall consist of one or more logical records. For each logical record contained in the file, several information fields appropriate to that record type shall be present. Each information field may contain one or more basic single-valued information items. Taken together these items are used to convey different aspects of the data contained in that field. An information field may also consist of one or more information items grouped together and repeated multiple times within a field. Such a group of information items is known as a subfield. An information field may therefore consist of one or more subfields of information items. 2.1. Information separators In the tagged-field logical records, mechanisms for delimiting information are implemented by use of four ASCII information separators. The delimited information may be items within a field or subfield, fields within a logical record, or multiple occurrences of subfields. These information separators are defined in the standard ANSI X3.4. These characters are used to separate and qualify information in a logical sense. Viewed in a hierarchical relationship, the File Separator \"FS\" character is the most inclusive followed by the Group Separator \"GS\", the Record Separator \"RS\", and finally the Unit Separator \"US\" characters. Table 1 lists these ASCII separators and a description of their use within this standard. Information separators should be functionally viewed as an indication of the type data that follows. The \"US\" character shall separate individual information items within a field or subfield. This is a signal that the next information item is a piece of data for that field or subfield. Multiple subfields within a field separated by the \"RS\" character signals the start of the next group of repeated information item(s). The \"GS\" separator character used between information fields signals the beginning of a new field preceding the field identifying number that shall appear. Similarly, the beginning of a new logical record shall be signalled by the appearance of the \"FS\" character. The four characters are only meaningful when used as separators of data items in the fields of the ASCII text records. There is no specific meaning attached to these characters occurring in binary image records and binary fields \u2014 they are just part of the exchanged data. Normally, there should be no empty fields or information items and therefore only one separator character should appear between any two data items. The exception to this rule occurs for those instances where the data in fields or information items in a transaction are unavailable, missing, or optional, and the processing of the transaction is not dependent upon the presence of that particular data. In those instances, multiple and adjacent separator characters shall appear together rather than requiring the insertion of dummy data between separator characters. For the definition of a field that consists of three information items, the following applies. If the information for the second information item is missing, then two adjacent \"US\" information separator characters would occur between the first and third information items. If the second and third information items were both missing, then three separator characters should be used \u2014 two \"US\" characters in addition to the terminating field or subfield separator character. In general, if one or more mandatory or optional information items are unavailable for a field or subfield, then the appropriate number of separator character should be inserted. It is possible to have side-by-side combinations of two or more of the four available separator characters. When data are missing or unavailable for information items, subfields, or fields, there shall be one separator character less than the number of data items, subfields, or fields required. Table 1 Separators Used Code Type Description Hexadecimal Value Decimal Value US Unit Separator Separates information items 1F 31 RS Record Separator Separates subfields 1E 30 GS Group Separator Separates fields 1D 29 FS File Separator Separates logical records 1C 28 2.2. Record layout For tagged-field logical records, each information field that is used shall be numbered in accordance with this standard. The format for each field shall consist of the logical record type number followed by a period \".\", a field number followed by a colon \":\", followed by the information appropriate to that field. The tagged-field number can be any one-to-nine digit number occurring between the period \".\" and the colon \":\". It shall be interpreted as an unsigned integer field number. This implies that a field number of \"2.123:\" is equivalent to and shall be interpreted in the same manner as a field number of \"2.000000123:\". For purposes of illustration throughout this document, a three-digit number shall be used for enumerating the fields contained in each of the tagged-field logical records described herein. Field numbers will have the form of \"TT.xxx:\" where the \"TT\" represents the one- or two-character record type followed by a period. The next three characters comprise the appropriate field number followed by a colon. Descriptive ASCII information or the image data follows the colon. Logical Type-1 and Type-2 records contain only ASCII textual data fields. The entire length of the record (including field numbers, colons, and separator characters) shall be recorded as the first ASCII field within each of these record types. The ASCII File Separator \"FS\" control character (signifying the end of the logical record or transaction) shall follow the last byte of ASCII information and shall be included in the length of the record. In contrast to the tagged-field concept, the Type-4 record contains only binary data recorded as ordered fixed-length binary fields. The entire length of the record shall be recorded in the first four-byte binary field of each record. For this binary record, neither the record number with its period, nor the field identifier number and its following colon, shall be recorded. Furthermore, as all the field lengths of this record is either fixed or specified, none of the four separator characters (\"US\", \"RS\", \"GS\", or \"FS\") shall be interpreted as anything other than binary data. For the binary record, the \"FS\" character shall not be used as a record separator or transaction terminating character. 3. Type-1 Logical Record: the File Header This record describes the structure of the file, the type of the file, and other important information. The character set used for Type-1 fields shall contain only the 7-bit ANSI code for information interchange. 3.1. Fields for Type-1 Logical Record 3.1.1. Field 1.001: Logical Record Length (LEN) This field contains the total count of the number of bytes in the whole Type-1 logical record. The field begins with \"1.001:\", followed by the total length of the record including every character of every field and the information separators. 3.1.2. Field 1.002: Version Number (VER) To ensure that users know which version of the ANSI/NIST standard is being used, this four byte field specifies the version number of the standard being implemented by the software or system creating the file. The first two bytes specify the major version reference number, the second two the minor revision number. For example, the original 1986 Standard would be considered the first version and designated \"0100\" while the present ANSI/NIST-ITL 1-2000 standard is \"0300\". 3.1.3. Field 1.003: File Content (CNT) This field lists each of the records in the file by record type and the order in which the records appear in the logical file. It consists of one or more subfields, each of which in turn contains two information items describing a single logical record found in the current file. The subfields are entered in the same order in which the records are recorded and transmitted. The first information item in the first subfield is \"1\", to refer to this Type-1 record. It is followed by a second information item which contains the number of other records contained in the file. This number is also equal to the count of the remaining subfields of field 1.003. Each of the remaining subfields is associated with one record within the file, and the sequence of subfields corresponds to the sequence of records. Each subfield contains two items of information. The first is to identify the Type of the record. The second is the record's IDC. The \"US\" character shall be used to separate the two information items. 3.1.4. Field 1.004: Type of Transaction (TOT) This field contains a three letter mnemonic designating the type of the transaction. These codes may be different from those used by other implementations of the ANSI/NIST standard. CPS: Criminal Print-to-Print Search. This transaction is a request for a search of a record relating to a criminal offence against a prints database. The person's prints shall be included as WSQ-compressed images in the file. In case of a No-HIT, the following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record. In case of a HIT, the following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record, \u2014 1-14 Type-4 Record. The CPS TOT is summarised in Table A.6.1 (Appendix 39-6). PMS: Print-to-Latent Search. This transaction is used when a set of prints is searched against an Unidentified Latent database. The response will contain the HIT/No-HIT decision of the destination AFIS search. If multiple unidentified latents exist, multiple SRE transactions will be returned, with one latent per transaction. The person's prints shall be included as WSQ-compressed images in the file. In case of a No-HIT, the following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record. In case of a HIT, the following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record, \u2014 1 Type-13 Record. The PMS TOT is summarised in Table A.6.1 (Appendix 39-6). MPS: Latent-to-Print Search. This transaction is used when a latent is to be searched against a Prints database. The latent minuti\u00e6 information and the image (WSQ-compressed) shall be included in the file. In case of a No-HIT, the following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record. In case of a HIT, the following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record, \u2014 1 Type-4 or Type-15 Record. The MPS TOT is summarised in Table A.6.4 (Appendix 39-6). MMS: Latent-to-Latent Search. In this transaction the file contains a latent which is to be searched against an Unidentified Latent database in order to establish links between various scenes of crime. The latent minuti\u00e6 information and the image (WSQ-compressed) must be included in the file. In case of a No-HIT, the following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record. In case of a HIT, the following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record, \u2014 1 Type-13 Record. The MMS TOT is summarised in Table A.6.4 (Appendix 39-6). SRE: This transaction is returned by the destination agency in response to dactyloscopic submissions. The response will contain the HIT/No-HIT decision of the destination AFIS search. If multiple candidates exist, multiple SRE transactions will be returned, with one candidate per transaction. The SRE TOT is summarised in Table A.6.2 (Appendix 39-6). ERR: This transaction is returned by the destination AFIS to indicate a transaction error. It includes a message field (ERM) indicating the error detected. The following logical records will be returned: \u2014 1 Type-1 Record, \u2014 1 Type-2 Record. The ERR TOT is summarised in Table A.6.3 (Appendix 39-6). Table 2 Permissible Codes in Transactions Transaction Type Logical Record Type 1 2 4 9 13 15 CPS M M M \u2014 \u2014 \u2014 SRE M M C \u2014 (C in case of latent HITs) C C MPS M M \u2014 M (1*) M \u2014 MMS M M \u2014 M (1*) M \u2014 PMS M M M* \u2014 \u2014 M* ERR M M \u2014 \u2014 \u2014 \u2014 Key: M = Mandatory, M* = Only one of both record-types may be included, O = Optional, C = Conditional on whether data is available, \u2014 = Not allowed, 1* = Conditional depending on legacy systems. 3.1.5. Field 1.005: Date of Transaction (DAT) This field indicates the date on which the transaction was initiated and shall conform to the ISO standard notation of: YYYYMMDD where YYYY is the year, MM is the month and DD is the day of the month. Leading zeros are used for single figure numbers. For example, \"19931004\" represents 4 October 1993. 3.1.6. Field 1.006: Priority (PRY) This optional field defines the priority, on a level of 1 to 9, of the request. \"1\" is the highest priority and \"9\" the lowest. Priority \"1\" transactions shall be processed immediately. 3.1.7. Field 1.007: Destination Agency Identifier (DAI) This field specifies the destination agency for the transaction. It consists of two information items in the following format: CC/agency. The first information item contains the Country Code, defined in ISO 3166, two alpha-numeric characters long. The second item, agency, is a free text identification of the agency, up to a maximum of 32 alpha-numeric characters. 3.1.8. Field 1.008: Originating Agency Identifier (ORI) This field specifies the file originator and has the same format as the DAI (Field 1.007). 3.1.9. Field 1.009: Transaction Control Number (TCN) This is a control number for reference purposes. It should be generated by the computer and have the following format: YYSSSSSSSSA where YY is the year of the transaction, SSSSSSSS is an eight-digit serial number, and A is a check character generated by following the procedure given in Appendix 39-2. Where a TCN is not available, the field, YYSSSSSSSS, is filled with zeros and the check character generated as above. 3.1.10. Field 1.010: Transaction Control Response (TCR) Where a request was sent out, to which this is the response, this optional field will contain the transaction control number of the request message. It therefore has the same format as TCN (Field 1.009). 3.1.11. Field 1.011: Native Scanning Resolution (NSR) This field specifies the normal scanning resolution of the system supported by the originator of the transaction. The resolution is specified as two numeric digits followed by the decimal point and then two more digits. For all transactions pursuant to Articles 533 and 534 of this Agreement the sampling rate shall be 500 pixels/inch or 19,68 pixels/mm. 3.1.12. Field 1.012: Nominal Transmitting Resolution (NTR) This five-byte field specifies the nominal transmitting resolution for the images being transmitted. The resolution is expressed in pixels/mm in the same format as NSR (Field 1.011). 3.1.13. Field 1.013: Domain name (DOM) This mandatory field identifies the domain name for the user-defined Type-2 logical record implementation. It consists of two information items and shall be \"INT-I{}{US}}4.22{}{GS}}\". 3.1.14. Field 1.014: Greenwich mean time (GMT) This mandatory field provides a mechanism for expressing the date and time in terms of universal Greenwich Mean Time (GMT) units. If used, the GMT field contains the universal date that will be in addition to the local date contained in Field 1.005 (DAT). Use of the GMT field eliminates local time inconsistencies encountered when a transaction and its response are transmitted between two places separated by several time zones. The GMT provides a universal date and 24-hour clock time independent of time zones. It is represented as \"CCYYMMDDHHMMSSZ\", a 15-character string that is the concatenation of the date with the GMT and concludes with a \"Z\". The \"CCYY\" characters shall represent the year of the transaction, the \"MM\" characters shall be the tens and units values of the month, and the \"DD\" characters shall be the tens and units values of the day of the month, the \"HH\" characters represent the hour, the \"MM\" the minute, and the \"SS\" represents the second. The complete date shall not exceed the current date. 4. Type-2 Logical Record: Descriptive Text The structure of most of this record is not defined by the original ANSI/NIST standard. The record contains information of specific interest to the agencies sending or receiving the file. To ensure that communicating dactyloscopic systems are compatible, it is required that only the fields listed below are contained within the record. This document specifies which fields are mandatory and which optional, and also defines the structure of the individual fields. 4.1. Fields for Type-2 Logical Record 4.1.1. Field 2.001: Logical Record Length (LEN) This mandatory field contains the length of this Type-2 record, and specifies the total number of bytes including every character of every field contained in the record and the information separators. 4.1.2. Field 2.002: Image Designation Character (IDC) The IDC contained in this mandatory field is an ASCII representation of the IDC as defined in the File Content field (CNT) of the Type-1 record (Field 1.003). 4.1.3. Field 2.003: System Information (SYS) This field is mandatory and contains four bytes which indicate which version of the INT-I this particular Type-2 record complies with. The first two bytes specify the major version number, the second two the minor revision number. For example, this implementation is based on INT-I version 4 revision 22 and would be represented as \"0422\". 4.1.4. Field 2.007: Case Number (CNO) This is a number assigned by the local dactyloscopic bureau to a collection of latents found at a scene-of-crime. The following format is adopted: CC/number where CC is the Interpol Country Code, two alpha-numeric characters in length, and the number complies with the appropriate local guidelines and may be up to 32 alpha-numeric characters long. This field allows the system to identify latents associated with a particular crime. 4.1.5. Field 2.008: Sequence Number (SQN) This specifies each sequence of latents within a case. It can be up to four numeric characters long. A sequence is a latent or series of latents which are grouped together for the purposes of filing and/or searching. This definition implies that even single latents will still have to be assigned a sequence number. This field together with MID (Field 2.009) may be included to identify a particular latent within a sequence. 4.1.6. Field 2.009: Latent Identifier (MID) This specifies the individual latent within a sequence. The value is a single letter or two letters, with \"A\" assigned to the first latent, \"B\" to the second, and so on up to a limit of \"ZZ\". This field is used analogue to the latent sequence number discussed in the description for SQN (Field 2.008). 4.1.7. Field 2.010: Criminal Reference Number (CRN) This is a unique reference number assigned by a national agency to an individual who is charged for the first time with committing an offence. Within one country no individual ever has more than one CRN, or shares it with any other individual. However, the same individual may have Criminal Reference Numbers in several countries, which will be distinguishable by means of the country code. The following format is adopted for CRN field: CC/number where CC is the Country Code, defined in ISO 3166, two alpha-numeric characters in length, and the number complies with the appropriate national guidelines of the issuing agency, and may be up to 32 alpha-numeric characters long. For transactions pursuant to Articles 533 and 534 of this Agreement this field will be used for the national criminal reference number of the originating agency which is linked to the images in Type-4 or Type-15 Records. 4.1.8. Field 2.012: Miscellaneous Identification Number (MN1) This fields contains the CRN (Field 2.010) transmitted by a CPS or PMS transaction without the leading country code. 4.1.9. Field 2.013: Miscellaneous Identification Number (MN2) This fields contains the CNO (Field 2.007) transmitted by an MPS or MMS transaction without the leading country code. 4.1.10. Field 2.014: Miscellaneous Identification Number (MN3) This fields contains the SQN (Field 2.008) transmitted by an MPS or MMS transaction. 4.1.11. Field 2.015: Miscellaneous Identification Number (MN4) This fields contains the MID (Field 2.009) transmitted by an MPS or MMS transaction. 4.1.12. Field 2.063: Additional Information (INF) In case of an SRE transaction to a PMS request this field gives information about the finger which caused the possible HIT. The format of the field is: NN where NN is the finger position code defined in Table 5, two digits in length. In all other cases the field is optional. It consists of up to 32 alpha-numeric characters and may give additional information about the request. 4.1.13. Field 2.064: Respondents List (RLS) This field contains at least two subfields. The first subfield describes the type of search that has been carried out, using the three-letter mnemonics which specify the transaction type in TOT (Field 1.004). The second subfield contains a single character. An \"I\" shall be used to indicate that a HIT has been found and an \"N\" shall be used to indicate that no matching cases have been found (No-HIT). The third subfield contains the sequence identifier for the candidate result and the total number of candidates separated by a slash. Multiple messages will be returned if multiple candidates exist. In case of a possible HIT the fourth subfield shall contain the score up to six digits long. If the HIT has been verified the value of this subfield is defined as \"999999\". Example: \"CPS{}{RS}}I{}{RS}}001/001{}{RS}}999999{}{GS}}\" If the remote AFIS does not assign scores, then a score of zero should be used at the appropriate point. 4.1.14. Field 2.074: Status/Error Message Field (ERM) This field contains error messages resulting from transactions, which will be sent back to the requester as part of an Error Transaction. Table 3 Error messages Numeric code (1-3) Meaning (5-128) 003 ERROR: UNAUTHORISED ACCESS 101 Mandatory field missing 102 Invalid record type 103 Undefined field 104 Exceed the maximum occurrence 105 Invalid number of subfields 106 Field length too short 107 Field length too long 108 Field is not a number as expected 109 Field number value too small 110 Field number value too big 111 Invalid character 112 Invalid date 115 Invalid item value 116 Invalid type of transaction 117 Invalid record data 201 ERROR: INVALID TCN 501 ERROR: INSUFFICIENT FINGERPRINT QUALITY 502 ERROR: MISSING FINGERPRINTS 503 ERROR: FINGERPRINT SEQUENCE CHECK FAILED 999 ERROR: ANY OTHER ERROR. FOR FURTHER DETAILS CALL DESTINATION AGENCY. Error messages in the range between 100 and 199: These error messages are related to the validation of the ANSI/NIST records and defined as: <error_code 1>: IDC <idc_number 1> FIELD <field_id 1> <dynamic text 1> LF <error_code 2>: IDC <idc_number 2> FIELD <field_id 2> <dynamic text 2>\u2026 where \u2014 error_code is a code uniquely related to a specific reason (see Table 3), \u2014 field_id is the ANSI/NIST field number of the incorrect field (e.g. 1.001, 2.001, \u2026) in the format <record_type>.<field_id>.<sub_field_id>, \u2014 dynamic text is a more detailed dynamic description of the error, \u2014 LF is a Line Feed separating errors if more than one error is encountered, \u2014 for type-1 record the ICD is defined as \"-1\". Example: 201: IDC - 1 FIELD 1.009 WRONG CONTROL CHARACTER {}{LF}} 115: IDC 0 FIELD 2.003 INVALID SYSTEM INFORMATION This field is mandatory for error transactions. 4.1.15. Field 2.320: Expected Number of Candidates (ENC) This field contains the maximum number of candidates for verification expected by the requesting agency. The value of ENC shall not exceed the values defined in Table 11. 5. Type-4 Logical Record: High Resolution GreyScale Image It should be noted that Type-4 records are binary rather than ASCII in nature. Therefore each field is assigned a specific position within the record, which implies that all fields are mandatory. The standard allows both image size and resolution to be specified within the record. It requires Type-4 Logical Records to contain dactyloscopic image data that are being transmitted at a nominal pixel density of 500 to 520 pixels per inch. The preferred rate for new designs is at a pixel density of 500 pixels per inch or 19,68 pixels per mm. 500 pixels per inch is the density specified by the INT-I, except that similar systems may communicate with each other at a non-preferred rate, within the limits of 500 to 520 pixels per inch. 5.1. Fields for Type-4 Logical Record 5.1.1. Field 4.001: Logical Record Length (LEN) This four-byte field contains the length of this Type-4 record, and specifies the total number of bytes including every byte of every field contained in the record. 5.1.2. Field 4.002: Image Designation Character (IDC) This is the one-byte binary representation of the IDC number given in the header file. 5.1.3. Field 4.003: Impression Type (IMP) The impression type is a single-byte field occupying the sixth byte of the record. Table 4 Finger Impression Type Code Description 0 Live-scan of plain fingerprint 1 Live-scan of rolled fingerprint 2 Non-live scan impression of plain fingerprint captured from paper 3 Non-live scan impression of rolled fingerprint captured from paper 4 Latent impression captured directly 5 Latent tracing 6 Latent photo 7 Latent lift 8 Swipe 9 Unknown 5.1.4. Field 4.004: Finger Position (FGP) This fixed-length field of six bytes occupies the seventh through twelfth byte positions of a Type-4 record. It contains possible finger positions beginning in the left most byte (byte seven of the record). The known or most probable finger position is taken from Table 5. Up to five additional fingers may be referenced by entering the alternate finger positions in the remaining five bytes using the same format. If fewer than five finger position references are to be used the unused bytes are filled with binary 255. To reference all finger positions code 0, for unknown, is used. Table 5 Finger position code and maximum size Finger position Finger code Width (mm) Length (mm) Unknown 0 40,0 40,0 Right thumb 1 45,0 40,0 Right index finger 2 40,0 40,0 Right middle finger 3 40,0 40,0 Right ring finger 4 40,0 40,0 Right little finger 5 33,0 40,0 Left thumb 6 45,0 40,0 Left index finger 7 40,0 40,0 Left middle finger 8 40,0 40,0 Left ring finger 9 40,0 40,0 Left little finger 10 33,0 40,0 Plain right thumb 11 30,0 55,0 Plain left thumb 12 30,0 55,0 Plain right four fingers 13 70,0 65,0 Plain left four fingers 14 70,0 65,0 For scene of crime latents only the codes 0 to 10 should be used. 5.1.5. Field 4.005: Image Scanning Resolution (ISR) This one-byte field occupies the 13th byte of a Type-4 record. If it contains \"0\" then the image has been sampled at the preferred scanning rate of 19,68 pixels/mm (500 pixels per inch). If it contains \"1\" then the image has been sampled at an alternative scanning rate as specified in the Type-1 record. 5.1.6. Field 4.006: Horizontal Line Length (HLL) This field is positioned at bytes 14 and 15 within the Type-4 record. It specifies the number of pixels contained in each scan line. The first byte will be the most significant. 5.1.7. Field 4.007: Vertical Line Length (VLL) This field records in bytes 16 and 17 the number of scan lines present in the image. The first byte is the most significant. 5.1.8. Field 4.008: Greyscale Compression Algorithm (GCA) This one-byte field specifies the greyscale compression algorithm used to encode the image data. For this implementation, a binary code 1 indicates that WSQ compression (Appendix 39-7) has been used. 5.1.9. Field 4.009: The Image This field contains a byte stream representing the image. Its structure will obviously depend on the compression algorithm used. 6. Type-9 Logical Record: Minuti\u00e6 Record Type-9 records shall contain ASCII text describing minuti\u00e6 and related information encoded from a latent. For latent search transaction, there is no limit for these Type-9 records in a file, each of which shall be for a different view or latent. 6.1. Minuti\u00e6 extraction 6.1.1. Minutia type identification This standard defines three identifier numbers that are used to describe the minutia type. These are listed in Table 6. A ridge ending shall be designated Type 1. A bifurcation shall be designated Type 2. If a minutia cannot be clearly categorised as one of the above two types, it shall be designated as \"other\", Type 0. Table 6 Minutia types Type Description 0 Other 1 Ridge ending 2 Bifurcation 6.1.2. Minutia placement and type For templates to be compliant with Section 5 of the ANSI INCITS 378-2004 standard, the following method, which enhances the current INCITS 378-2004 standard, shall be used for determining placement (location and angular direction) of individual minuti\u00e6. The position or location of a minutia representing a ridge ending shall be the point of forking of the medial skeleton of the valley area immediately in front of the ridge ending. If the three legs of the valley area were thinned down to a single-pixel-wide skeleton, the point of the intersection is the location of the minutia. Similarly, the location of the minutia for a bifurcation shall be the point of forking of the medial skeleton of the ridge. If the three legs of the ridge were each thinned down to a single-pixel-wide skeleton, the point where the three legs intersect is the location of the minutia. After all ridge endings have been converted to bifurcations, all of the minuti\u00e6 of the dactyloscopic image are represented as bifurcations. The X and Y pixel coordinates of the intersection of the three legs of each minutia can be directly formatted. Determination of the minutia direction can be extracted from each skeleton bifurcation. The three legs of every skeleton bifurcation shall be examined and the endpoint of each leg determined. Figure 6.1.2 illustrates the three methods used for determining the end of a leg that is based on a scanning resolution of 500 ppi. The ending is established according to the event that occurs first. The pixel count is based on a scan resolution of 500 ppi. Different scan resolutions would imply different pixel counts. \u2014 a distance of 0,064\" (the 32nd pixel), \u2014 the end of skeleton leg that occurs between a distance of 0,02\" and 0,064\" (the 10th through the 32nd pixels); shorter legs are not used, \u2014 a second bifurcation is encountered within a distance of 0,064\" (before the 32nd pixel). The angle of the minuti\u00e6 is determined by constructing three virtual rays originating at the bifurcation point and extending to the end of each leg. The smallest of the three angles formed by the rays is bisected to indicate the minuti\u00e6 direction. 6.1.3. Coordinate system The coordinate system used to express the minuti\u00e6 of a fingerprint shall be a Cartesian coordinate system. Minuti\u00e6 locations shall be represented by their x and y coordinates. The origin of the coordinate system shall be the upper left corner of the original image with x increasing to the right and y increasing downward. Both x and y coordinates of a minuti\u00e6 shall be represented in pixel units from the origin. It should be noted that the location of the origin and units of measure is not in agreement with the convention used in the definitions of the Type 9 in the ANSI/NIST-ITL 1-2000. 6.1.4. Minuti\u00e6 direction Angles are expressed in standard mathematical format, with zero degrees to the right and angles increasing in the counter clockwise direction. Recorded angles are in the direction pointing back along the ridge for a ridge ending and toward the centre of the valley for a bifurcation. This convention is 180 degrees opposite of the angle convention described in the definitions of the Type 9 in the ANSI/NIST-ITL 1-2000. 6.2. Fields for Type-9 Logical record INCITS-378 Format All fields of the Type-9 records shall be recorded as ASCII text. No binary fields are permissible in this tagged-field record. 6.2.1. Field 9.001: Logical record length (LEN) This mandatory ASCII field shall contain the length of the logical record specifying the total number of bytes, including every character of every field contained in the record. 6.2.2. Field 9.002: Image designation character (IDC) This mandatory two-byte field shall be used for the identification and location of the minuti\u00e6 data. The IDC contained in this field shall match the IDC found in the file content field of the Type-1 record. 6.2.3. Field 9.003: Impression type (IMP) This mandatory one-byte field shall describe the manner by which the dactyloscopic image information was obtained. The ASCII value of the proper code as selected from Table 4 shall be entered in this field to signify the impression type. 6.2.4. Field 9.004: Minuti\u00e6 format (FMT) This field shall contain a \"U\" to indicate that the minuti\u00e6 are formatted in M1-378 terms. Even though information may be encoded in accordance with the M1-378 standard, all data fields of the Type-9 record shall remain as ASCII text fields. 6.2.5. Field 9.126: CBEFF information This field shall contain three information items. The first information item shall contain the value \"27\" (0x1B). This is the identification of the CBEFF Format Owner assigned by the International Biometric Industry Association (IBIA) to INCITS Technical Committee M1. The <US> character shall delimit this item from the CBEFF Format Type that is assigned a value of \"513\" (0x0201) to indicate that this record contains only location and angular direction data without any Extended Data Block information. The <US> character shall delimit this item from the CBEFF Product Identifier (PID) that identifies the \"owner\" of the encoding equipment. The vendor establishes this value. It can be obtained from the IBIA website (www.ibia.org) if it is posted. 6.2.6. Field 9.127: Capture equipment identification This field shall contain two information items separated by the <US> character. The first shall contain \"APPF\" if the equipment used originally to acquire the image was certified to comply with Appendix F (IAFIS Image Quality Specification, 29 January 1999) of CJIS-RS-0010, the Federal Bureau of Investigation's Electronic Fingerprint Transmission Specification. If the equipment did not comply, it will contain the value of \"NONE\". The second information item shall contain the Capture Equipment ID which is a vendor-assigned product number of the capture equipment. A value of \"0\" indicates that the capture equipment ID is unreported. 6.2.7. Field 9.128: Horizontal line length (HLL) This mandatory ASCII field shall contain the number of pixels contained on a single horizontal line of the transmitted image. The maximum horizontal size is limited to 65534 pixels. 6.2.8. Field 9.129: Vertical line length (VLL) This mandatory ASCII field shall contain the number of horizontal lines contained in the transmitted image. The maximum vertical size is limited to 65534 pixels. 6.2.9. Field 9.130: Scale units (SLC) This mandatory ASCII field shall specify the units used to describe the image sampling frequency (pixel density). A \"1\" in this field indicates pixels per inch, or a \"2\" indicates pixels per centimetre. A \"0\" in this field indicates no scale is given. In this case, the quotient of HPS/VPS gives the pixel aspect ratio. 6.2.10. Field 9.131: Horizontal pixel scale (HPS) This mandatory ASCII field shall specify the integer pixel density used in the horizontal direction providing the SLC contains a \"1\" or a \"2\". Otherwise, it indicates the horizontal component of the pixel aspect ratio. 6.2.11. Field 9.132: Vertical pixel scale (VPS) This mandatory ASCII field shall specify the integer pixel density used in the vertical direction providing the SLC contains a \"1\" or a \"2\". Otherwise, it indicates the vertical component of the pixel aspect ratio. 6.2.12. Field 9.133: Finger view This mandatory field contains the view number of the finger associated with this record's data. The view number begins with \"0\" and increments by one to \"15\". 6.2.13. Field 9.134: Finger position (FGP) This field shall contain the code designating the finger position that produced the information in this Type-9 record. A code between 1 and 10 taken from Table 5 or the appropriate palm code from Table 10 shall be used to indicate the finger or palm position. 6.2.14. Field 9.135: Finger quality The field shall contain the quality of the overall finger minuti\u00e6 data and shall be between 0 and 100. This number is an overall expression of the quality of the finger record, and represents quality of the original image, of the minutia extraction and any additional operations that may affect the minuti\u00e6 record. 6.2.15. Field 9.136: number of minuti\u00e6 The mandatory field shall contain a count of the number of minuti\u00e6 recorded in this logical record. 6.2.16. Field 9.137: Finger minuti\u00e6 data This mandatory field has six information items separated by the <US> character. It consists of several subfields, each containing the details of single minutiae. The total number of minutiae subfields must agree with the count found in field 136. The first information item is the minutiae index number, which shall be initialised to \"1\" and incremented by \"1\" for each additional minutia in the fingerprint. The second and third information items are the \"x\" coordinate and \"y\" coordinates of the minutiae in pixel units. The fourth information item is the minutiae angle recorded in units of two degrees. This value shall be nonnegative between 0 and 179. The fifth information item is the minutiae type. A value of \"0\" is used to represent minutiae of type \"OTHER\", a value of \"1\" for a ridge ending and a value of \"2\" for a ridge bifurcation. The sixth information item represents the quality of each minutiae. This value shall range from 1 as a minimum to 100 as a maximum. A value of \"0\" indicates that no quality value is available. Each subfield shall be separated from the next with the use of the <RS> separator character. 6.2.17. Field 9.138: Ridge count information This field consists of a series of subfields each containing three information items. The first information item of the first subfield shall indicate the ridge count extraction method. A \"0\" indicates that no assumption shall be made about the method used to extract ridge counts, nor their order in the record. A \"1\" indicates that for each centre minuti\u00e6, ridge count data was extracted to the nearest neighbouring minuti\u00e6 in four quadrants, and ridge counts for each centre minutia are listed together. A \"2\" indicates that for each centre minuti\u00e6, ridge count data was extracted to the nearest neighbouring minuti\u00e6 in eight octants, and ridge counts for each centre minutia are listed together. The remaining two information items of the first subfield shall both contain \"0\". Information items shall be separated by the <US> separator character. Subsequent subfields will contain the centre minuti\u00e6 index number as the first information item, the neighbouring minuti\u00e6 index number as the second information item, and the number of ridges crossed as the third information item. Subfields shall be separated by the <RS> separator character. 6.2.18. Field 9.139: Core information This field will consist of one subfield for each core present in the original image. Each subfield consists of three information items. The first two items contain the \"x\" and \"y\" coordinate positions in pixel units. The third information item contains the angle of the core recorded in units of 2 degrees. The value shall be a nonnegative value between 0 and 179. Multiple cores will be separated by the <RS> separator character. 6.2.19. Field 9.140: Delta information This field will consist of one subfield for each delta present in the original image. Each subfield consists of three information items. The first two items contain the \"x\" and \"y\" coordinate positions in pixel units. The third information item contains the angle of the delta recorded in units of 2 degrees. The value shall be a nonnegative value between 0 and 179. Multiple cores will be separated by the <RS> separator character. 7. Type-13 variable-resolution latent image record The Type-13 tagged-field logical record shall contain image data acquired from latent images. These images are intended to be transmitted to agencies that will automatically extract or provide human intervention and processing to extract the desired feature information from the images. Information regarding the scanning resolution used, the image size, and other parameters required to process the image, are recorded as tagged-fields within the record. Table 7 Type-13 variable-resolution latent record layout Ident Cond. code Field Number Field name Char type Field size per occurrence Occur count Max byte count min. max. min max LEN M 13.001 LOGICAL RECORD LENGTH N 4 8 1 1 15 IDC M 13.002 IMAGE DESIGNATION CHARACTER N 2 5 1 1 12 IMP M 13.003 IMPRESSION TYPE A 2 2 1 1 9 SRC M 13.004 SOURCE AGENCY/ORI AN 6 35 1 1 42 LCD M 13.005 LATENT CAPTURE DATE N 9 9 1 1 16 HLL M 13.006 HORIZONTAL LINE LENGTH N 4 5 1 1 12 VLL M 13.007 VERTICAL LINE LENGTH N 4 5 1 1 12 SLC M 13.008 SCALE UNITS N 2 2 1 1 9 HPS M 13.009 HORIZONTAL PIXEL SCALE N 2 5 1 1 12 VPS M 13.010 VERTICAL PIXEL SCALE N 2 5 1 1 12 CGA M 13.011 COMPRESSION ALGORITHM A 5 7 1 1 14 BPX M 13.012 BITS PER PIXEL N 2 3 1 1 10 FGP M 13.013 FINGER POSITION N 2 3 1 6 25 RSV 13.014 RESERVED FOR FUTURE DEFINITION \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 13.019 COM O 13.020 COMMENT A 2 128 0 1 135 RSV 13.021 RESERVED FOR FUTURE DEFINITION \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 13.199 UDF O 13.200 USER-DEFINED FIELDS \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 13.998 DAT M 13.999 IMAGE DATA B 2 \u2014 1 1 \u2014 Key for character type: N = Numeric; A = Alphabetic; AN = Alphanumeric; B = Binary 7.1. Fields for the Type-13 logical record The following paragraphs describe the data contained in each of the fields for the Type-13 logical record. Within a Type-13 logical record, entries shall be provided in numbered fields. It is required that the first two fields of the record are ordered, and the field containing the image data shall be the last physical field in the record. For each field of the Type-13 record, Table 7 lists the \"condition code\" as being mandatory \"M\" or optional \"O\", the field number, the field name, character type, field size, and occurrence limits. Based on a three digit field number, the maximum byte count size for the field is given in the last column. As more digits are used for the field number, the maximum byte count will also increase. The two entries in the \"field size per occurrence\" include all character separators used in the field. The \"maximum byte count\" includes the field number, the information, and all the character separators including the \"GS\" character. 7.1.1. Field 13.001: Logical record length (LEN) This mandatory ASCII field shall contain the total count of the number of bytes in the Type-13 logical record. Field 13.001 shall specify the length of the record including every character of every field contained in the record and the information separators. 7.1.2. Field 13.002: Image designation character (IDC) This mandatory ASCII field shall be used to identify the latent image data contained in the record. This IDC shall match the IDC found in the file content (CNT) field of the Type-1 record. 7.1.3. Field 13.003: Impression type (IMP) This mandatory one- or two-byte ASCII field shall indicate the manner by which the latent image information was obtained. The appropriate latent code choice selected from Table 4 (finger) or Table 9 (palm) shall be entered in this field. 7.1.4. Field 13.004: Source agency/ORI (SRC) This mandatory ASCII field shall contain the identification of the administration or organisation that originally captured the facial image contained in the record. Normally, the Originating Agency Identifier (ORI) of the agency that captured the image will be contained in this field. It consists of two information items in the following format: CC/agency. The first information item contains the Interpol Country Code, two alpha-numeric characters long. The second item, agency, is a free text identification of the agency, up to a maximum of 32 alpha-numeric characters. 7.1.5. Field 13.005: Latent capture date (LCD) This mandatory ASCII field shall contain the date that the latent image contained in the record was captured. The date shall appear as eight digits in the format CCYYMMDD. The CCYY characters shall represent the year the image was captured; the MM characters shall be the tens and unit values of the month; and the DD characters shall be the tens and unit values of the day in the month. For example, 20000229 represents 29 February 2000. The complete date shall be a legitimate date. 7.1.6. Field 13.006: Horizontal line length (HLL) This mandatory ASCII field shall contain the number of pixels contained on a single horizontal line of the transmitted image. 7.1.7. Field 13.007: Vertical line length (VLL) This mandatory ASCII field shall contain the number of horizontal lines contained in the transmitted image. 7.1.8. Field 13.008: Scale units (SLC) This mandatory ASCII field shall specify the units used to describe the image sampling frequency (pixel density). A \"1\" in this field indicates pixels per inch, or a \"2\" indicates pixels per centimetre. A \"0\" in this field indicates no scale is given. In this case, the quotient of HPS/VPS gives the pixel aspect ratio. 7.1.9. Field 13.009: Horizontal pixel scale (HPS) This mandatory ASCII field shall specify the integer pixel density used in the horizontal direction providing the SLC contains a \"1\" or a \"2\". Otherwise, it indicates the horizontal component of the pixel aspect ratio. 7.1.10. Field 13.010: Vertical pixel scale (VPS) This mandatory ASCII field shall specify the integer pixel density used in the vertical direction providing the SLC contains a \"1\" or a \"2\". Otherwise, it indicates the vertical component of the pixel aspect ratio. 7.1.11. Field 13.011: Compression algorithm (CGA) This mandatory ASCII field shall specify the algorithm used to compress greyscale images. See Appendix 39-7 for the compression codes. 7.1.12. Field 13.012: Bits per pixel (BPX) This mandatory ASCII field shall contain the number of bits used to represent a pixel. This field shall contain an entry of \"8\" for normal greyscale values of \"0\" to \"255\". Any entry in this field greater than \"8\" shall represent a greyscale pixel with increased precision. 7.1.13. Field 13.013: Finger/palm position (FGP) This mandatory tagged-field shall contain one or more of the possible finger or palm positions that may match the latent image. The decimal code number corresponding to the known or most probable finger position shall be taken from Table 5 or the most probable palm position from Table 10 and entered as a one- or two-character ASCII subfield. Additional finger and/or palm positions may be referenced by entering the alternate position codes as subfields separated by the \"RS\" separator character. The code \"0\", for \"Unknown Finger\", shall be used to reference every finger position from one through ten. The code \"20\", for \"Unknown Palm\", shall be used to reference every listed palmprint position. 7.1.14. Field 13.014-019: Reserved for future definition (RSV) These fields are reserved for inclusion in future revisions of this standard. None of these fields are to be used at this revision level. If any of these fields are present, they are to be ignored. 7.1.15. Field 13.020: Comment (COM) This optional field may be used to insert comments or other ASCII text information with the latent image data. 7.1.16. Field 13.021-199: Reserved for future definition (RSV) These fields are reserved for inclusion in future revisions of this standard. None of these fields are to be used at this revision level. If any of these fields are present, they are to be ignored. 7.1.17. Fields 13.200-998: User-defined fields (UDF) These fields are user-definable fields and will be used for future requirements. Their size and content shall be defined by the user and be in accordance with the receiving agency. If present they shall contain ASCII textual information. 7.1.18. Field 13.999: Image data (DAT) This field shall contain all data from a captured latent image. It shall always be assigned field number 999 and shall be the last physical field in the record. For example, \"13.999:\" is followed by image data in a binary representation. Each pixel of uncompressed greyscale data shall normally be quantised to eight bits (256 grey levels) contained in a single byte. If the entry in BPX Field 13.012 is greater or less than \"8\", the number of bytes required to contain a pixel will be different. If compression is used, the pixel data shall be compressed in accordance with the compression technique specified in the GCA field. 7.2. End of Type-13 variable-resolution latent image record For the sake of consistency, immediately following the last byte of data from Field 13.999 an \"FS\" separator shall be used to separate it from the next logical record. This separator shall be included in the length field of the Type-13 record. 8. Type-15 variable-resolution palmprint image record The Type-15 tagged-field logical record shall contain and be used to exchange palmprint image data together with fixed and user-defined textual information fields pertinent to the digitised image. Information regarding the scanning resolution used, the image size and other parameters or comments required to process the image are recorded as tagged-fields within the record. Palmprint images transmitted to other agencies will be processed by the recipient agencies to extract the desired feature information required for matching purposes. The image data shall be acquired directly from a subject using a live-scan device, or from a palmprint card or other media that contains the subject's palmprints. Any method used to acquire the palmprint images shall be capable of capturing a set of images for each hand. This set shall include the writer's palm as a single scanned image, and the entire area of the full palm extending from the wrist bracelet to the tips of the fingers as one or two scanned images. If two images are used to represent the full palm, the lower image shall extend from the wrist bracelet to the top of the interdigital area (third finger joint) and shall include the thenar, and hypothenar areas of the palm. The upper image shall extend from the bottom of the interdigital area to the upper tips of the fingers. This provides an adequate amount of overlap between the two images that are both located over the interdigital area of the palm. By matching the ridge structure and details contained in this common area, an examiner can confidently state that both images came from the same palm. As a palmprint transaction may be used for different purposes, it may contain one or more unique image areas recorded from the palm or hand. A complete palmprint record set for one individual will normally include the writer's palm and the full palm image(s) from each hand. Since a tagged-field logical image record may contain only one binary field, a single Type-15 record will be required for each writer's palm and one or two Type-15 records for each full palm. Therefore, four to six Type-15 records will be required to represent the subject's palmprints in a normal palmprint transaction. 8.1. Fields for the Type-15 logical record The following paragraphs describe the data contained in each of the fields for the Type-15 logical record. Within a Type-15 logical record, entries shall be provided in numbered fields. It is required that the first two fields of the record are ordered, and the field containing the image data shall be the last physical field in the record. For each field of the Type-15 record, Table 8 lists the \"condition code\" as being mandatory \"M\" or optional \"O\", the field number, the field name, character type, field size, and occurrence limits. Based on a three digit field number, the maximum byte count size for the field is given in the last column. As more digits are used for the field number, the maximum byte count will also increase. The two entries in the \"field size per occurrence\" include all character separators used in the field. The \"maximum byte count\" includes the field number, the information, and all the character separators including the \"GS\" character. 8.1.1. Field 15.001: Logical record length (LEN) This mandatory ASCII field shall contain the total count of the number of bytes in the Type-15 logical record. Field 15.001 shall specify the length of the record including every character of every field contained in the record and the information separators. 8.1.2. Field 15.002: Image designation character (IDC) This mandatory ASCII field shall be used to identify the palmprint image contained in the record. This IDC shall match the IDC found in the file content (CNT) field of the Type-1 record. 8.1.3. Field 15.003: Impression type (IMP) This mandatory one-byte ASCII field shall indicate the manner by which the palmprint image information was obtained. The appropriate code selected from Table 9 shall be entered in this field. 8.1.4. Field 15.004: Source agency/ORI (SRC) This mandatory ASCII field shall contain the identification of the administration or organisation that originally captured the facial image contained in the record. Normally, the Originating Agency Identifier (ORI) of the agency that captured the image will be contained in this field. It consists of two information items in the following format: CC/agency. The first information item contains the Interpol Country Code, two alpha-numeric characters long. The second item, agency, is a free text identification of the agency, up to a maximum of 32 alpha-numeric characters. 8.1.5. Field 15.005: Palmprint capture date (PCD) This mandatory ASCII field shall contain the date that the palmprint image was captured. The date shall appear as eight digits in the format CCYYMMDD. The CCYY characters shall represent the year the image was captured; the MM characters shall be the tens and unit values of the month; and the DD characters shall be the tens and units values of the day in the month. For example, the entry 20000229 represents 29 February 2000. The complete date shall be a legitimate date. 8.1.6. Field 15.006: Horizontal line length (HLL) This mandatory ASCII field shall contain the number of pixels contained on a single horizontal line of the transmitted image. 8.1.7. Field 15.007: Vertical line length (VLL) This mandatory ASCII field shall contain the number of horizontal lines contained in the transmitted image. 8.1.8. Field 15.008: Scale units (SLC) This mandatory ASCII field shall specify the units used to describe the image sampling frequency (pixel density). A \"1\" in this field indicates pixels per inch, or a \"2\" indicates pixels per centimetre. A \"0\" in this field indicates no scale is given. In this case, the quotient of HPS/VPS gives the pixel aspect ratio. 8.1.9. Field 15.009: Horizontal pixel scale (HPS) This mandatory ASCII field shall specify the integer pixel density used in the horizontal direction providing the SLC contains a \"1\" or a \"2\". Other-wise, it indicates the horizontal component of the pixel aspect ratio. 8.1.10. Field 15.010: Vertical pixel scale (VPS) This mandatory ASCII field shall specify the integer pixel density used in the vertical direction providing the SLC contains a \"1\" or a \"2\". Otherwise, it indicates the vertical component of the pixel aspect ratio. Table 8 Type-15 variable-resolution palmprint record layout Ident Cond. code Field number Field name Char type Field size per occurrence Occur count Max byte count min. max. min max LEN M 15.001 LOGICAL RECORD LENGTH N 4 8 1 1 15 IDC M 15.002 IMAGE DESIGNATION CHARACTER N 2 5 1 1 12 IMP M 15.003 IMPRESSION TYPE N 2 2 1 1 9 SRC M 15.004 SOURCE AGENCY/ORI AN 6 35 1 1 42 PCD M 15.005 PALMPRINT CAPTURE DATE N 9 9 1 1 16 HLL M 15.006 HORIZONTAL LINE LENGTH N 4 5 1 1 12 VLL M 15.007 VERTICAL LINE LENGTH N 4 5 1 1 12 SLC M 15.008 SCALE UNITS N 2 2 1 1 9 HPS M 15.009 HORIZONTAL PIXEL SCALE N 2 5 1 1 12 VPS M 15.010 VERTICAL PIXEL SCALE N 2 5 1 1 12 CGA M 15.011 COMPRESSION ALGORITHM AN 5 7 1 1 14 BPX M 15.012 BITS PER PIXEL N 2 3 1 1 10 PLP M 15.013 PALMPRINT POSITION N 2 3 1 1 10 RSV 15.014 RESERVED FOR FUTURE INCLUSION \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 15.019 COM O 15.020 COMMENT AN 2 128 0 1 128 RSV 15.021 RESERVED FOR FUTURE INCLUSION \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 15.199 UDF O 15.200 USER-DEFINED FIELDS \u2014 \u2014 \u2014 \u2014 \u2014 \u2014 15.998 DAT M 15.999 IMAGE DATA B 2 \u2014 1 1 \u2014 Table 9 Palm Impression Type Description Code Live-scan palm 10 Nonlive-scan palm 11 Latent palm impression 12 Latent palm tracing 13 Latent palm photo 14 Latent palm lift 15 8.1.11. Field 15.011: Compression algorithm (CGA) This mandatory ASCII field shall specify the algorithm used to compress greyscale images. An entry of \"NONE\" in this field indicates that the data contained in this record are uncompressed. For those images that are to be compressed, this field shall contain the preferred method for the compression of tenprint fingerprint images. Valid compression codes are defined in Appendix 39-7. 8.1.12. Field 15.012: Bits per pixel (BPX) This mandatory ASCII field shall contain the number of bits used to represent a pixel. This field shall contain an entry of \"8\" for normal greyscale values of \"0\" to \"255\". Any entry in this field greater than or less than \"8\" shall represent a greyscale pixel with increased or decreased precision respectively. Table 10 Palm Codes, Areas and Sizes Palm Position Palm code Image area (mm2) Width (mm) Height (mm) Unknown Palm 20 28387 139,7 203,2 Right Full Palm 21 28387 139,7 203,2 Right Writer s Palm 22 5645 44,5 127,0 Left Full Palm 23 28387 139,7 203,2 Left Writer s Palm 24 5645 44,5 127,0 Right Lower Palm 25 19516 139,7 139,7 Right Upper Palm 26 19516 139,7 139,7 Left Lower Palm 27 19516 139,7 139,7 Left Upper Palm 28 19516 139,7 139,7 Right Other 29 28387 139,7 203,2 Left Other 30 28387 139,7 203,2 8.1.13. Field 15.013: Palmprint position (PLP) This mandatory tagged-field shall contain the palmprint position that matches the palmprint image. The decimal code number corresponding to the known or most probable palmprint position shall be taken from Table 10 and entered as a two-character ASCII subfield. Table 10 also lists the maximum image areas and dimensions for each of the possible palmprint positions. 8.1.14. Field 15.014-019: Reserved for future definition (RSV) These fields are reserved for inclusion in future revisions of this standard. None of these fields are to be used at this revision level. If any of these fields are present, they are to be ignored. 8.1.15. Field 15.020: Comment (COM) This optional field may be used to insert comments or other ASCII text information with the palmprint image data. 8.1.16. Field 15.021-199: Reserved for future definition (RSV) These fields are reserved for inclusion in future revisions of this standard. None of these fields are to be used at this revision level. If any of these fields are present, they are to be ignored. 8.1.17. Fields 15.200-998: User-defined fields (UDF) These fields are user-definable fields and will be used for future requirements. Their size and content shall be defined by the user and be in accordance with the receiving agency. If present, they shall contain ASCII textual information. 8.1.18. Field 15.999: Image data (DAT) This field shall contain all of the data from a captured palmprint image. It shall always be assigned field number 999 and shall be the last physical field in the record. For example, \"15.999:\" is followed by image data in a binary representation. Each pixel of uncompressed greyscale data shall normally be quantised to eight bits (256 grey levels) contained in a single byte. If the entry in BPX Field 15.012 is greater or less than 8, the number of bytes required to contain a pixel will be different. If compression is used, the pixel data shall be compressed in accordance with the compression technique specified in the CGA field. 8.2. End of Type-15 variable-resolution palmprint image record For the sake of consistency, immediately following the last byte of data from Field 15.999 an \"FS\" separator shall be used to separate it from the next logical record. This separator shall be included in the length field of the Type-15 record. 8.3. Additional Type-15 variable-resolution palmprint image records Additional Type-15 records may be included in the file. For each additional palmprint image, a complete Type-15 logical record together with the \"FS\" separator is required. Table 11 Maximum numbers of candidates accepted for verification per transmission Type of AFIS Search TP/TP LT/TP LP/PP TP/UL LT/UL PP/ULP LP/ULP Maximum Number of Candidates 1 10 5 5 5 5 5 Search types: TP/TP: ten-print against ten-print LT/TP: fingerprint latent against ten-print LP/PP: palmprint latent against palmprint TP/UL: ten-print against unsolved fingerprint latent LT/UL: fingerprint latent against unsolved fingerprint latent PP/ULP: palmprint against unsolved palmprint latent LP/ULP: palmprint latent against unsolved palmprint latent 9. Appendices to Chapter 2 (exchange of dactyloscopic data) 9.1. Appendix 39-1: ASCII Separator Codes ASCII Position (2) Description LF 1/10 Separates error codes in Field 2.074 FS 1/12 Separates logical records of a file GS 1/13 Separates fields of a logical record RS 1/14 Separates the subfields of a record field US 1/15 Separates individual information items of the field or subfield 9.2. Appendix 39-2: Calculation of Alpha-Numeric Check Character For TCN and TCR (Fields 1.09 and 1.10): The number corresponding to the check character is generated using the following formula: (YY * 108 + SSSSSSSS) Modulo 23 Where YY and SSSSSSSS are the numerical values of the last two digits of the year and the serial number respectively. The check character is then generated from the look-up table given below. For CRO (Field 2.010) The number corresponding to the check character is generated using the following formula: (YY * 106 + NNNNNN) Modulo 23 Where YY and NNNNNN are the numerical values of the last two digits of the year and the serial number respectively. The check character is then generated from the look-up table given below. Check Character Look-up Table 1-A 9-J 17-T 2-B 10-K 18-U 3-C 11-L 19-V 4-D 12-M 20-W 5-E 13-N 21-X 6-F 14-P 22-Y 7-G 15-Q 0-Z 8-H 16-R 9.3. Appendix 39-3: Character Codes 7-bit ANSI code for information interchange ASCII Character Set + 0 1 2 3 4 5 6 7 8 9 30 ! \u2019 # $ % & \u2018 40 ( ) * + , - . / 0 1 50 2 3 4 5 6 7 8 9 : ; 60 < = > ? @ A B C D E 70 F G H I J K L M N O 80 P Q R S T U V W X Y 90 Z [ \\ ] ^ _ ` a b c 100 d e f g h i j k l m 110 n o p q r s t u v w 120 x y z {}{ | }} ~ 9.4. Appendix 39-4: Transaction Summary Type 1 Record (mandatory) Identifier Field number Field name CPS/PMS SRE ERR LEN 1.001 Logical Record Length M M M VER 1.002 Version Number M M M CNT 1.003 File Content M M M TOT 1.004 Type of Transaction M M M DAT 1.005 Date M M M PRY 1.006 Priority M M M DAI 1.007 Destination Agency M M M ORI 1.008 Originating Agency M M M TCN 1.009 Transaction Control Number M M M TCR 1.010 Transaction Control Reference C M M NSR 1.011 Native Scanning Resolution M M M NTR 1.012 Nominal Transmitting Resolution M M M DOM 1.013 Domain name M M M GMT 1.014 Greenwich mean time M M M Under the Condition Column: O = Optional; M = Mandatory; C = Conditional if transaction is a response to the origin agency Type 2 Record (mandatory) Identifier Field number Field name CPS/PMS MPS/MMS SRE ERR LEN 2.001 Logical Record Length M M M M IDC 2.002 Image Designation Character M M M M SYS 2.003 System Information M M M M CNO 2.007 Case Number \u2014 M C \u2014 SQN 2.008 Sequence Number \u2014 C C \u2014 MID 2.009 Latent Identifier \u2014 C C \u2014 CRN 2.010 Criminal Reference Number M \u2014 C \u2014 MN1 2.012 Miscellaneous Identification Number \u2014 \u2014 C C MN2 2.013 Miscellaneous Identification Number \u2014 \u2014 C C MN3 2.014 Miscellaneous Identification Number \u2014 \u2014 C C MN4 2.015 Miscellaneous Identification Number \u2014 \u2014 C C INF 2.063 Additional Information O O O O RLS 2.064 Respondents List \u2014 \u2014 M \u2014 ERM 2.074 Status/Error Message Field \u2014 \u2014 \u2014 M ENC 2.320 Expected Number of Candidates M M \u2014 \u2014 Under the Condition Column: O = Optional; M = Mandatory; C = Conditional if data is available * = if the transmission of the data is in accordance with domestic law (not covered by Articles 533 and 534 of this Agreement) 9.5. Appendix 39-5: Type-1 Record Definitions Identifier Condition Field number Field name Character type Example data LEN M 1.001 Logical Record Length N 1.001:230{}{GS}} VER M 1.002 Version Number N 1.002:0300{}{GS}} CNT M 1.003 File Content N 1.003:1{}{US}}15{}{RS}}2{}{US}}00{}{RS}}4{}{US}}01{}{RS}}4{}{US}}02{}{RS}}4{}{US}}03{}{RS}}4{}{US}}04{}{RS}}4{}{US}}05{}{RS}}4{}{US}}06{}{RS}}4{}{US}}07{}{RS}}4{}{US}}08{}{RS}}4{}{US}}09{}{RS}}4{}{US}}10{}{RS}}4{}{US}}11{}{RS}}4{}{US}}12{}{RS}}4{}{US}}13{}{RS}}4{}{US}}14{}{GS}} TOT M 1.004 Type of Transaction A 1.004:CPS{}{GS}} DAT M 1.005 Date N 1.005:20050101{}{GS}} PRY M 1.006 Priority N 1.006:4{}{GS}} DAI M 1.007 Destination Agency 1* 1.007:DE/BKA{}{GS}} ORI M 1.008 Originating Agency 1* 1.008:NL/NAFIS{}{GS}} TCN M 1.009 Transaction Control Number AN 1.009:0200000004F{}{GS}} TCR C 1.010 Transaction Control Reference AN 1.010:0200000004F{}{GS}} NSR M 1.011 Native Scanning Resolution AN 1.011:19.68{}{GS}} NTR M 1.012 Nominal Transmitting Resolution AN 1.012:19,68{}{GS}} DOM M 1.013 Domain Name AN 1.013: INT-I{}{US}}4,22{}{GS}} GMT M 1.014 Greenwich Mean Time AN 1.014:20050101125959Z Under the Condition Column: O = Optional, M = Mandatory, C = Conditional Under the Character Type Column: A = Alpha, N = Numeric, B = Binary 1* allowed characters for agency name are [\"0..9\", \"A..Z\", \"a..z\", \"_\", \".\", \"\", \"-\"] 9.6. Appendix 39-6: Type-2 Record Definitions Table A.6.1 CPS- and PMS-Transaction Identifier Condition Field number Field name Character type Example data LEN M 2.001 Logical Record Length N 2.001:909{}{GS}} IDC M 2.002 Image Designation Character N 2.002:00{}{GS}} SYS M 2.003 System Information N 2.003:0422{}{GS}} CRN M 2.010 Criminal Reference Number AN 2.010:DE/E999999999{}{GS}} INF O 2.063 Additional Information 1* 2.063:Additional Information 123{}{GS}} ENC M 2.320 Expected Number of Candidates N 2.320:1{}{GS}} Table A.6.2 SRE-Transaction Identifier Condition Field number Field name Character type Example data LEN M 2.001 Logical Record Length N 2.001:909{}{GS}} IDC M 2.002 Image Designation Character N 2.002:00{}{GS}} SYS M 2.003 System Information N 2.003:0422{}{GS}} CRN C 2.010 Criminal Reference Number AN 2.010:NL/2222222222{}{GS}} MN1 C 2.012 Miscellaneous Identification Number AN 2.012:E999999999{}{GS}} MN2 C 2.013 Miscellaneous Identification Number AN 2.013:E999999999{}{GS}} MN3 C 2.014 Miscellaneous Identification Number N 2.014:0001{}{GS}} MN4 C 2.015 Miscellaneous Identification Number A 2.015:A{}{GS}} INF O 2.063 Additional Information 1* 2.063:Additional Information 123{}{GS}} RLS M 2.064 Respondents List AN 2.064:CPS{}{RS}}I{}{RS}}001/001{}{RS}}999999{}{GS}} Table A.6.3 ERR-Transaction Identifier Condition Field number Field name Character type Example data LEN M 2.001 Logical Record Length N 2.001:909{}{GS}} IDC M 2.002 Image Designation Character N 2.002:00{}{GS}} SYS M 2.003 System Information N 2.003:0422{}{GS}} MN1 M 2.012 Miscellaneous Identification Number AN 2.012:E999999999{}{GS}} MN2 C 2.013 Miscellaneous Identification Number AN 2.013:E999999999{}{GS}} MN3 C 2.014 Miscellaneous Identification Number N 2.014:0001{}{GS}} MN4 C 2.015 Miscellaneous Identification Number A 2.015:A{}{GS}} INF O 2.063 Additional Information 1* 2.063:Additional Information 123{}{GS}} ERM M 2.074 Status/Error Message Field AN 2.074: 201: IDC - 1 FIELD 1.009 WRONG CONTROL CHARACTER {}{LF}} 115: IDC 0 FIELD 2.003 INVALID SYSTEM INFORMATION {}{GS}} Table A.6.4 MPS- and MMS-Transaction Identifier Condition Field number Field name Character type Example data LEN M 2.001 Logical Record Length N 2.001:909{}{GS}} IDC M 2.002 Image Designation Character N 2.002:00{}{GS}} SYS M 2.003 System Information N 2.003:0422{}{GS}} CNO M 2.007 Case Number AN 2.007:E999999999{}{GS}} SQN C 2.008 Sequence Number N 2.008:0001{}{GS}} MID C 2.009 Latent Identifier A 2.009:A{}{GS}} INF O 2.063 Additional Information 1* 2.063:Additional Information 123{}{GS}} ENC M 2.320 Expected Number of Candidates N 2.320:1{}{GS}} Under the Condition Column: O = Optional, M = Mandatory, C = Conditional Under the Character Type Column: A = Alpha, N = Numeric, B = Binary 1* allowed characters are [\"0..9\", \"A..Z\", \"a..z\", \"_\", \".\", \"\", \"-\", \",\"] 9.7. Appendix 39-7: Greyscale Compression Codes Compression Codes Compression Value Remarks Wavelet Scalar Quantisation Greyscale Fingerprint Image Compression Specification IAFIS-IC-0010(V3), dated 19 December 1997 WSQ Algorithm to be used for the compression of greyscale images in Type-4, Type-7 and Type-13 to Type-15 records. Shall not be used for resolutions > 500 dpi. JPEG 2000 [ISO 15444/ITU T.800] J2K To be used for lossy and losslessly compression of greyscale images in Type-13 to Type-15 records. Strongly recommended for resolutions > 500 dpi 9.8. Appendix 39-8: Mail specification To improve the internal workflow the mail subject of a PRUEM transaction has to be filled with the country code (CC) of the State that send the message and the Type of Transaction (TOT Field 1.004). Format: CC/type of transaction Example: \"DE/CPS\" The mail body can be empty. CHAPTER 3 EXCHANGE OF VEHICLE REGISTRATION DATA 1. Common data-set for automated search of vehicle registration data 1.1. Definitions The definitions of mandatory and optional data elements set out in Article 14(4) of Chapter 0 are as follows: Mandatory (M): The data element has to be communicated when the information is available in a State's national register. Therefore there is an obligation to exchange the information when available. Optional (O): The data element may be communicated when the information is available in a State's national register. Therefore there is no obligation to exchange the information even when the information is available. An indication (Y) is given for each element in the data set where the element is specifically identified as important in relation with Article 537 of this Agreement. 1.2. Vehicle/owner/holder search 1.2.1. Triggers for the search There are two different ways to search for the information as defined in the next paragraph: \u2014 by Chassis Number (VIN), Reference Date and Time (optional), \u2014 by License Plate Number, Chassis Number (VIN) (optional), Reference Date and Time (optional). By means of these search criteria, information related to one and sometimes more vehicles will be returned. If information for only one vehicle has to be returned, all the items are returned in one response. If more than one vehicle is found, the requested State itself can determine which items will be returned; all items or only the items to refine the search (e.g. because of privacy reasons or because of performance reasons). The items necessary to refine the search are pictured in paragraph 1.2.2.1. In paragraph 1.2.2.2 the complete information set is described. When the search is done by Chassis Number, Reference Date and Time, the search can be done in one or all of the participating States. When the search is done by License Number, Reference Data and Time, the search has to be done in one specific State. Normally the actual Date and Time is used to make a search, but it is possible to conduct a search with a Reference Date and Time in the past. When a search is made with a Reference Date and Time in the past and historical information is not available in the register of the specific State because no such information is registered at all, the actual information can be returned with an indication that the information is actual information. 1.2.2. Data set 1.2.2.1. Items to be returned necessary for the refinement of the search Item M/O (3) Remarks Pr\u00fcm Y/N (4) Data relating to vehicles Licence number M Y Chassis number/VIN M Y Country of registration M Y Make M (D.1 (5)) e.g. Ford, Opel, Renault, etc. Y Commercial type of the vehicle M (D.3) e.g. Focus, Astra, Megane Y EU Category Code M (J) mopeds, motorbikes, cars, etc. Y 1.2.2.2. Complete data set Item M/O (6) Remarks Pr\u00fcm Y/N Data relating to holders of the vehicle (C.1 (7)) The data refer to the holder of the specific registration certificate. Registration holders' (company) name M (C.1.1.) separate fields will be used for surname, infixes, titles, etc., and the name in printable format will be communicated Y First name M (C.1.2) separate fields for first name(s) and initials will be used, and the name in printable format will be communicated Y Address M (C.1.3) separate fields will be used for Street, House number and Annex, Zip code, Place of residence, Country of residence, etc., and the Address in printable format will be communicated Y Gender M Male, female Y Date of birth M Y Legal entity M individual, association, company, firm, etc. Y Place of Birth O Y ID Number O An identifier that uniquely identifies the person or the company. N Type of ID Number O The type of ID Number (e.g. passport number). N Start date holdership O Start date of the holdership of the car. This date will often be the same as printed under (I) on the registration certificate of the vehicle. N End date holdership O End data of the holdership of the car. N Type of holder O If there is no owner of the vehicle (C.2) the reference to the fact that the holder of the registration certificate: \u2014 is the vehicle owner, \u2014 is not the vehicle owner, \u2014 is not identified by the registration certificate as being the vehicle owner. N Data relating to owners of the vehicle (C.2) Owners' (company) name M (C.2.1) Y First name M (C.2.2) Y Address M (C.2.3) Y Gender M male, female Y Date of birth M Y Legal entity M individual, association, company, firm, etc. Y Place of Birth O Y ID Number O An identifier that uniquely identifies the person or the company. N Type of ID Number O The type of ID Number (e.g. passport number). N Start date ownership O Start date of the ownership of the car. N End date ownership O End data of the ownership of the car. N Data relating to vehicles Licence number M Y Chassis number/VIN M Y Country of registration M Y Make M (D.1) e.g. Ford, Opel, Renault, etc. Y Commercial type of the vehicle M (D.3) e.g. Focus, Astra, Megane. Y Nature of the vehicle/EU Category Code M (J) mopeds, motorbikes, cars, etc. Y Date of first registration M (B) Date of first registration of the vehicle somewhere in the world. Y Start date (actual) registration M (I) Date of the registration to which the specific certificate of the vehicle refers. Y End date registration M End data of the registration to which the specific certificate of the vehicle refers. It is possible this date indicates the period of validity as printed on the document if not unlimited (document abbreviation = H). Y Status M Scrapped, stolen, exported, etc. Y Start date status M Y End date status O N kW O (P.2) Y Capacity O (P.1) Y Type of licence number O Regular, transito, etc. Y Vehicle document id 1 O The first unique document ID as printed on the vehicle document. Y Vehicle document id 2 (8) O A second document ID as printed on the vehicle document. Y Data relating to insurances Insurance company name O Y Begin date insurance O Y End date insurance O Y Address O Y Insurance number O Y ID number O An identifier that uniquely identifies the company. N Type of ID number O The type of ID number (e.g. number of the Chamber of Commerce) N 2. Data Security 2.1. Overview The Eucaris software application handles secure communication to the other States and communicates to the back-end legacy systems of States using XML. States exchange messages by directly sending them to the recipient. The data centre of a State is connected to the TESTA network. The XML-messages sent over the network are encrypted. The technique to encrypt these messages is SSL. The messages sent to the back-end are plain text XML-messages since the connection between the application and the back-end shall be in a protected environment. A client application is provided which can be used within a State to query their own register or other States' registers. The clients will be identified by means of user-id/password or a client certificate. The connection to a user may be encrypted, but this is the responsibility of each individual State. 2.2. Security Features related to message exchange The security design is based on a combination of HTTPS and XML signature. This alternative uses XML-signature to sign all messages sent so the server and can authenticate the sender of the message by checking the signature. 1-sided SSL (only a server certificate) is used to protect the confidentiality and integrity of the message in transit and provides protection against deletion/replay and insertion attacks. Instead of bespoke software development to implement 2-sided SSL, XML-signature is implemented. Using XML-signature is closer to the web services roadmap than 2-sided SSL and therefore more strategic. The XML-signature can be implemented in several ways but the chosen approach is to use XML Signature as part of the Web Services Security (WSS). WSS specifies how to use XML-signature. Since WSS builds upon the SOAP standard, it is logical to adhere to the SOAP standard as much as possible. 2.3. Security features not related to message exchange 2.3.1. Authentication of users The users of the Eucaris web application authenticate themselves using a username and password. Since standard Windows authentication is used, States can enhance the level of authentication of users if needed by using client certificates. 2.3.2. User roles The Eucaris software application supports different user roles. Each cluster of services has its own authorisation. E.g. (exclusive) users of the \"'Treaty of Eucaris' \u2014 functionality\" may not use the \"'Pr\u00fcm' \u2014 functionality\". Administrator services are separated from the regular end-user roles. 2.3.3. Logging and tracing of message exchange Logging of all message types is facilitated by the Eucaris software application. An administrator function allows the national administrator to determine which messages are logged: requests from end-users, incoming requests from other States, provided information from the national registers, etc. The application can be configured to use an internal database for this logging, or an external (Oracle) database. The decision on what messages have to be logged clearly depends on logging facilities elsewhere in the legacy systems and connected client applications. The header of each message contains information on the requesting State, the requesting organisation within that State and the user involved. Also the reason of the request is indicated. By means of the combined logging in the requesting and responding State complete tracing of any message exchange is possible (e.g. on request of a citizen involved). Logging is configured through the Eucaris web client (menu Administration, Logging configuration). The logging functionality is performed by the Core System. When logging is enabled, the complete message (header and body) is stored in one logging record. Per defined service, and per message type that passes along the Core System, the logging level can be set. Logging Levels The following logging levels are possible: Private \u2014 Message is logged: The logging is NOT available to the extract logging service but is available on a national level only, for audits and problem solving. None \u2014 Message is not logged at all. Message Types Information exchange between States consists of several messages, of which a schematic representation is given in Figure 5 below. The possible message types (in Figure 5 shown for the Eucaris Core System of State X) are the following: 1. Request to Core System_Request message by Client; 2. Request to Other State_Request message by Core System of this State; 3. Request to Core System of this State_Request message by Core System of other State; 4. Request to Legacy Register_Request message by Core System; 5. Request to Core System_Request message by Legacy Register; 6. Response from Core System_Request message by Client; 7. Response from Other State_Request message by Core System of this State; 8. Response from Core System of this State_Request message by other State; 9. Response from Legacy Register_Request message by Core System; 10. Response from Core System_Request message by Legacy Register. The following information exchanges are shown in Figure 5: \u2014 Information request from State X to State Y \u2014 blue arrows. This request and response consists of message types 1, 2, 7 and 6, respectively, \u2014 Information request from State Z to State X \u2014 red arrows. This request and response consists of message types 3, 4, 9 and 8, respectively, \u2014 Information request from the legacy register to its core system (this route also includes a request from a custom client behind the legacy register) \u2014 green arrows. This kind of request consists of message types 5 and 10. 2.3.4. Hardware Security Module A Hardware Security Module is not used. A Hardware Security Module (HSM) provides good protection for the key used to sign messages and to identify servers. This adds to the overall level of security but an HSM is expensive to buy/maintain and there are no requirements to decide for a FIPS 140-2 level 2 or level 3 HSM. Since a closed network is used that mitigates threats effectively, it is decided not to use an HSM initially. If an HSM is necessary e.g. to obtain accreditation, it can be added to the architecture. 3. Technical conditions of the data exchange 3.1. General description of the Eucaris application 3.1.1. Overview The Eucaris application connects all participating States in a mesh network where each State communicates directly to another State. There is no central component needed for the communication to be established. The Eucaris application handles secure communication to the other States and communicates to the back-end legacy systems of States using XML. The following picture visualises this architecture. States exchange messages by directly sending them to the recipient. The data centre of a State is connected to the network used for the message exchange (TESTA). To access the TESTA network, States connect to TESTA via their national gate. A firewall shall be used to connect to the network and a router connects the Eucaris application to the firewall. Depending on the alternative chosen to protect the messages, a certificate is used either by the router or by the Eucaris application. A client application is provided which can be used within a State to query its own register or other States' registers. The client application connects to Eucaris. The clients will be identified by means of user-id/password or a client certificate. The connection to a user in an external organisation (e.g. police) may be encrypted but this is the responsibility of each individual State. 3.1.2. Scope of the system The scope of the Eucaris system is limited to the processes involved in the exchange of information between the Registration Authorities in the States and a basic presentation of this information. Procedures and automated processes in which the information is to be used, are outside the scope of the system. States can choose either to use the Eucaris client functionality or to set up their own customised client application. The table below describes which aspects of the Eucaris system are mandatory to use and/or prescribed and which are optional to use and/or free to determine by the States. Eucaris aspects M/O (9) Remark Network concept M The concept is an \"any-to-any\" communication. Physical network M TESTA Core application M The core application of Eucaris has to be used to connect to the other States. The following functionality is offered by the core: \u2014 Encrypting and signing of the messages; \u2014 Checking of the identity of the sender; \u2014 Authorisation of States and local users; \u2014 Routing of messages; \u2014 Queuing of asynchronous messages if the recipient service is temporally unavailable; \u2014 Multiple country inquiry functionality; \u2014 Logging of the exchange of messages; \u2014 Storage of incoming messages Client application O In addition to the core application the Eucaris II client application can be used by a State. When applicable, the core and client application are modified under auspices of the Eucaris organisation. Security concept M The concept is based on XML-signing by means of client certificates and SSL-encryption by means of service certificates. Message specifications M Every State has to comply with the message specifications as set by the Eucaris organisation and this Chapter. The specifications can only be changed by the Eucaris organisation in consultation with the States. Operation and Support M The acceptance of new States or a new functionality is under auspices of the Eucaris organisation. Monitoring and help desk functions are managed centrally by an appointed State. 3.2. Functional and Non-Functional Requirements 3.2.1. Generic functionality In this section the main generic functions have been described in general terms. No Description 1. The system allows the Registration Authorities of the States to exchange request and response messages in an interactive way. 2. The system contains a client application, enabling end-users to send their requests and presenting the response information for manual processing 3. The system facilitates \"broadcasting\", allowing a State to send a request to all other States. The incoming responses are consolidated by the core application in one response message to the client application (this functionality is called a \"Multiple Country Inquiry\"). 4. The system is able to deal with different types of messages. User roles, authorisation, routing, signing and logging are all defined per specific service. 5. The system allows the States to exchange batches of messages or messages containing a large number of requests or replies. These messages are dealt with in an asynchronous way. 6. The system queues asynchronous messages if the recipient State is temporarily unavailable and guarantees the deliverance as soon as the recipient is up again. 7. The system stores incoming asynchronous messages until they can be processed. 8. The system only gives access to Eucaris applications of other States, not to individual organisations within those other States, i.e. each Registration Authority acts as the single gateway between its national end-users and the corresponding Authorities in the other States. 9. It is possible to define users of different States on one Eucaris server and to authorise them following the rights of that State. 10. Information on the requesting State, organisation and end user are included in the messages. 11. The system facilitates logging of the exchange of messages between the different States and between the core application and the national registration systems. 12. The system allows a specific secretary, which is an organisation or State explicitly appointed for this task, to gather logged information on messages sent/received by all the participating States, in order to produce statistical reports. 13. Each State indicates itself what logged information is made available for the secretary and what information is \"private\". 14. The system allows the National Administrators of each State to extract statistics of use. 15. The system enables addition of new States through simple administrative tasks. 3.2.2. Usability No Description 16. The system provides an interface for automated processing of messages by back-end systems/legacy and enables the integration of the user interface in those systems (customised user-interface). 17. The system is easy to learn, self-explanatory and contains help-text. 18. The system is documented to assist States in integration, operational activities and future maintenance (e.g. reference guides, functional/technical documentation, operational guide, \u2026). 19. The user interface is multi-lingual and offers facilities for the end-user to select a preferred language. 20. The user interface contains facilities for a Local Administrator to translate both screen-items and coded information to the national language. 3.2.3. Reliability No Description 21. The system is designed as a robust and dependable operational system which is tolerant to operator errors and which will recover cleanly from power cuts or other disasters. It shall be possible to restart the system with no or minimal loss of data. 22. The system shall give stable and reproducible results. 23. The system has been designed to function reliably. It is possible to implement the system in a configuration that guarantees an availability of 98 % (by redundancy, the use of back-up servers, etc.) in each bilateral communication. 24. It is possible to use part of the system, even during failure of some components (if State C is down, States A and B are still able to communicate). The number of single points of failure in the information chain should be minimised. 25. The recovery time after a severe failure should be less than one day. It should be possible to minimise down-time by using remote support, e.g. by a central service desk. 3.2.4. Performance No Description 26. The system can be used 24x7. This time-window (24x7) is then also required from the States' legacy systems. 27. The system responds rapidly to user requests irrespective of any background tasks. This is also required from the Parties legacy systems to ensure acceptable response time. An overall response time of 10 seconds maximum for a single request is acceptable. 28. The system has been designed as a multi-user system and in such a way that background tasks can continue while the user performs foreground tasks. 29. The system has been designed to be scaleable in order to support the potential increase of number of messages when new functionality is added or new organisations or States are added. 3.2.5. Security No Description 30. The system is suited (e.g. in its security measures) for the exchange of messages containing privacy-sensitive personal data (e.g. car owner/holders), classified as EU restricted. 31. The system is maintained in such a way that unauthorised access to the data is prevented. 32. The system contains a service for the management of the rights and permissions of national end-users. 33. States are able to check the identity of the sender (at State level), by means of XML-signing. 34. States shall explicitly authorise other States to request specific information. 35. The system provides at application level a full security and encryption policy compatible with the level of security required in such situations. Exclusiveness and integrity of the information is guaranteed by the use of XML-signing and encryption by means of SSL-tunnelling. 36. All exchange of messages can be traced by means of logging. 37. Protection is provided against deletion attacks (a third party deletes a message) and replay or insertion attacks (a third party replays or inserts a message). 38. The system makes use of certificates of a Trusted Third Party (TTP). 39. The system is able to handle different certificates per State, depending on the type of message or service. 40. The security measures at application level are sufficient to allow the use of non-accredited networks. 41. The system is able to use novice security techniques such as an XML-firewall. 3.2.6. Adaptability No Description 42. The system is extensible with new messages and new functionality. The costs of adaptations are minimal. Due to the centralised development of application components. 43. States are able to define new message types for bilateral use. Not all States are required to support all message types. 3.2.7. Support and Maintenance No Description 44. The system provides monitoring facilities for a central service-desk and/or operators concerning the network and servers in the different States. 45. The system provides facilities for remote support by a central service-desk. 46. The system provides facilities for problem analysis. 47. The system can be expanded to new States. 48. The application can easily be installed by staff with a minimum of IT-qualifications and experience. The installation procedure shall be as much as possible automated. 49. The system provides a permanent testing and acceptance environment. 50. The annual costs of maintenance and support has been minimised by adherence to market standards and by creating the application in such a way that as little support as possible from a central service-desk is required. 3.2.8. Design requirements No Description 51. The system is designed and documented for an operational lifetime of many years. 52. The system has been designed in such a way that it is independent of the network provider. 53. The system is compliant with the existing HW/SW in the States by interacting with those registration systems using open standard web service technology (XML, XSD, SOAP, WSDL, HTTP(s), Web services, WSS, X.509, etc.). 3.2.9. Applicable standards No Description 54. The system is compliant with data protection issues as stated in Regulation (EC) No 45/2001 (Articles 21, 22 and 23) and Directive 95/46/EC. 55. The system complies with the IDA Standards. 56. The system supports UTF8. CHAPTER 4 EVALUATION PROCEDURE REFERRED TO IN ARTICLE 540 Article 1 Questionnaire 1. The relevant Working Group of the Council of the European Union (the \"Council Working Group\") shall draw up a questionnaire concerning each of the automated data exchanges set out in Articles 527 to 539 of this Agreement. 2. As soon as the United Kingdom considers that it fulfils the prerequisites for sharing data in the relevant data category, it shall answer the relevant questionnaire. Article 2 Pilot run 1. If required, and with a view to evaluating the results of the questionnaire, the United Kingdom shall carry out a pilot run together with one or more other Member States already sharing data under Decision 2008/615/JHA. The pilot run takes place shortly before or shortly after the evaluation visit. 2. The conditions and arrangements for this pilot run shall be identified by the relevant Council Working Group and be based upon prior individual agreement with the United Kingdom. The States taking part in the pilot run shall decide on the practical details. Article 3 Evaluation visit 1. With a view to evaluating the results of the questionnaire, an evaluation visit shall take place. 2. The conditions and arrangement for this visit shall be identified by the relevant Council Working Group and be based upon prior individual agreement between the United Kingdom and the evaluation team. The United Kingdom shall enable the evaluation team to check the automated exchange of data in the data category or categories to be evaluated, in particular by organising a programme for the visit, which takes into account the requests of the evaluation team. 3. Within one month of the visit, the evaluation team shall produce a report on the evaluation visit and shall forward it to the United Kingdom for its comments. If appropriate, this report may be revised by the evaluation team on the basis of the United Kingdom's comments. 4. The evaluation team shall consist of no more than three experts, designated by the Member States taking part in the automated data exchange in the data categories to be evaluated, who have experience regarding the concerned data category, have the appropriate national security clearance to deal with these matters and are willing to take part in at least one evaluation visit in another State. The evaluation team shall also include a representative of the Commission. 5. The members of the evaluation team shall respect the confidential nature of the information they acquire when carrying out their task. Article 4 Evaluations carried out under Council Decisions 2008/615/JHA and 2008/616/JHA When carrying out the evaluation procedure as referred to in Article 540 of this Agreement and this Chapter, the Council, through the relevant Council Working Group, will take into account the results of the evaluation procedures, carried out in the context of the adoption of Council Implementing Decisions (EU) 2019/968 (10) and (EU) 2020/1188 (11). The relevant Council Working Group will decide on the necessity of carrying out the pilot run referred to in Article 540(1) of this Agreement, in Article 23(2) of Chapter 0 of this Annex, and in Article 2 of this Chapter. Article 5 Report to the Council An overall evaluation report, summarising the results of the questionnaires, the evaluation visit and, where applicable, the pilot run, shall be presented to the Council for its decision pursuant to Article 540 of this Agreement. (1) \"Full designated\" means the handling of rare allelle values is included. (2) This is the position as defined in the ASCII standard. (3) M = mandatory when available in national register, O = optional. (4) All the attributes specifically allocated by the States are indicated with Y. (5) Harmonised document abbreviation, see Council Directive 1999/37/EC of 29 April 1999. (6) M = mandatory when available in national register, O = optional. (7) Harmonised document abbreviation, see Council Directive 1999/37/EC of 29 April 1999. (8) In Luxembourg two separate vehicle registration document ID's are used. (9) M = mandatory to use or to comply with O = optional to use or to comply with. (10) Council Implementing Decision (EU) 2019/968 of 6 June 2019 on the launch of automated data exchange with regard to DNA data in the United Kingdom (OJ EU L 156, 13.6.2019, p. 8). (11) Council Implementing Decision (EU) 2020/1188 of 6 August 2020 on the launch of automated data exchange with regard to dactyloscopic data in the United Kingdom (OJ EU L 265, 12.8.2020, p. 1). ANNEX 40 PASSENGER NAME RECORD DATA Passenger name record data elements (as far as collected by air carriers): 1. PNR record locator; 2. Date of reservation/issue of ticket; 3. Date or dates of intended travel; 4. Name or names; 5. Address, telephone number and electronic contact information of the passenger, the persons who made the flight reservation for the passenger, persons through whom an air passenger may be contacted and persons who are to be informed in the event of an emergency; 6. All available payment/billing information (covering information relating solely to the payment methods for, and billing of, the air ticket, to the exclusion of any other information not directly relating to the flight); 7. Complete travel itinerary for specific PNR; 8. Frequent flyer information (the designator of the airline or vendor that administers the program, frequent flyer traveller number, membership level, tier description and alliance code); 9. Travel agency/travel agent; 10. Travel status of passenger, including confirmations, check-in status, no-show or go-show information; 11. Split/divided PNR information; 12. Other Supplementary Information (OSI), Special Service Information (SSI) and Special Service Request (SSR) information; 13. Ticketing field information, including ticket number, date of ticket issuance and one-way tickets, automated ticket fare quote fields; 14. Seat information, including seat number; 15. Code share information; 16. All baggage information; 17. The names of other passengers on the PNR and number of passengers on the PNR travelling together; 18. Any advance passenger information (API) data collected (type, number, country of issuance and expiry date of any identity document, nationality, family name, given name, gender, date of birth, airline, flight number, departure date, arrival date, departure port, arrival port, departure time and arrival time); 19. All historical changes to the PNR listed in points 1 to 18. ANNEX 41 FORMS OF CRIME FOR WHICH EUROPOL IS COMPETENT \u2014 Terrorism, \u2014 Organised crime, \u2014 Drug trafficking, \u2014 Money-laundering activities, \u2014 Crime connected with nuclear and radioactive substances, \u2014 Immigrant smuggling, \u2014 Trafficking in human beings, \u2014 Motor vehicle crime, \u2014 Murder and grievous bodily injury, \u2014 Illicit trade in human organs and tissue, \u2014 Kidnapping, illegal restraint and hostage-taking, \u2014 Racism and xenophobia, \u2014 Robbery and aggravated theft, \u2014 Illicit trafficking in cultural goods, including antiquities and works of art, \u2014 Swindling and fraud, \u2014 Crime against the financial interests of the Union, \u2014 Insider dealing and financial market manipulation, \u2014 Racketeering and extortion, \u2014 Counterfeiting and product piracy, \u2014 Forgery of administrative documents and trafficking therein, \u2014 Forgery of money and means of payment, \u2014 Computer crime, \u2014 Corruption, \u2014 Illicit trafficking in arms, ammunition and explosives, \u2014 Illicit trafficking in endangered animal species, \u2014 Illicit trafficking in endangered plant species and varieties, \u2014 Environmental crime, including ship-source pollution, \u2014 Illicit trafficking in hormonal substances and other growth promoters, \u2014 Sexual abuse and sexual exploitation, including child abuse material and solicitation of children for sexual purposes, \u2014 Genocide, crimes against humanity and war crimes. ANNEX 42 FORMS OF SERIOUS CRIME FOR WHICH EUROJUST IS COMPETENT \u2014 Terrorism, \u2014 Organised crime, \u2014 Drug trafficking, \u2014 Money-laundering activities, \u2014 Crime connected with nuclear and radioactive substances, \u2014 Immigrant smuggling, \u2014 Trafficking in human beings, \u2014 Motor vehicle crime, \u2014 Murder and grievous bodily injury, \u2014 Illicit trade in human organs and tissue, \u2014 Kidnapping, illegal restraint and hostage taking, \u2014 Racism and xenophobia, \u2014 Robbery and aggravated theft, \u2014 Illicit trafficking in cultural goods, including antiquities and works of art, \u2014 Swindling and fraud, \u2014 Crime against the financial interests of the Union, \u2014 Insider dealing and financial market manipulation, \u2014 Racketeering and extortion, \u2014 Counterfeiting and product piracy, \u2014 Forgery of administrative documents and trafficking therein, \u2014 Forgery of money and means of payment, \u2014 Computer crime, \u2014 Corruption, \u2014 Illicit trafficking in arms, ammunition and explosives, \u2014 Illicit trafficking in endangered animal species, \u2014 Illicit trafficking in endangered plant species and varieties, \u2014 Environmental crime, including ship source pollution, \u2014 Illicit trafficking in hormonal substances and other growth promoters, \u2014 Sexual abuse and sexual exploitation, including child abuse material and solicitation of children for sexual purposes, \u2014 Genocide, crimes against humanity and war crimes. ANNEX 43 ARREST WARRANT This warrant has been issued by a competent judicial authority. I request that the person mentioned below be arrested and surrendered for the purposes of conducting a criminal prosecution or executing a custodial sentence or detention order. (1) (a) Information regarding the identity of the requested person: Name: Forename(s): Maiden name, where applicable: Aliases, where applicable: Sex: Nationality: Date of birth: Place of birth: Residence and/or known address: Language(s) which the requested person understands (if known): Distinctive marks/description of the requested person: Photo and fingerprints of the requested person, if they are available and can be transmitted, or contact details of the person to be contacted in order to obtain such information or a DNA profile (where this evidence can be supplied but has not been included) (b) Decision on which the warrant is based: 1. Arrest warrant or judicial decision having the same effect: Type: 2. Enforceable judgement: Reference: (c) Indications on the length of the sentence: 1. Maximum length of the custodial sentence or detention order which may be imposed for the offence(s): 2. Length of the custodial sentence or detention order imposed: Remaining sentence to be served: (d) Indicate if the person appeared in person at the trial resulting in the decision: 1. \u2610 Yes, the person appeared in person at the trial resulting in the decision. 2. \u2610 No, the person did not appear in person at the trial resulting in the decision. 3. If you have ticked the box under point 2, please confirm the existence of one of the following, if applicable: \u2610 3.1a. the person was summoned in person on \u2026 (day/month/year) and thereby informed of the scheduled date and place of the trial which resulted in the decision and was informed that a decision may be handed down if he or she does not appear for the trial; OR \u2610 3.1b. the person was not summoned in person but by other means actually received official information of the scheduled date and place of the trial which resulted in the decision, in such a manner that it was unequivocally established that he or she was aware of the scheduled trial, and was informed that a decision may be handed down if he or she does not appear for the trial; OR \u2610 3.2. being aware of the scheduled trial, the person had given a mandate to a legal counsellor, who was either appointed by the person concerned or by the State, to defend him or her at the trial, and was indeed defended by that counsellor at the trial; OR \u2610 3.3. the person was served with the decision on \u2026 (day/month/year) and was expressly informed about the right to a retrial or appeal, in which he or she has the right to participate and which allows the merits of the case, including fresh evidence, to be re-examined, and which may lead to the original decision being reversed, and \u2610 the person expressly stated that he or she does not contest this decision; OR \u2610 the person did not request a retrial or appeal within the applicable timeframe; OR \u2610 3.4. the person was not personally served with the decision, but \u2014 the person will be personally served with this decision without delay after the surrender; and \u2014 when served with the decision, the person will be expressly informed of his or her right to a retrial or appeal, in which he or she has the right to participate and which allows the merits of the case, including fresh evidence, to be re-examined, and which may lead to the original decision being reversed; and \u2014 the person will be informed of the timeframe within which he or she has to request a retrial or appeal, which will be \u2026\u2026 days. 4. If you have ticked the box under point 3.1b, 3.2 or 3.3 above, please provide information about how the relevant condition has been met: \u2026 (e) Offences: This warrant relates to in total: offences Description of the circumstances in which the offence(s) was (were) committed, including the time, place and degree of participation in the offence(s) by the requested person: Nature and legal classification of the offence(s) and the applicable statutory provision/code: I. The following applies only in case both the issuing and the executing State have made a notification under Article 599(4) of the Agreement: if applicable, tick one or more of the following offences, as defined by the law of the issuing State, punishable in the issuing State by a custodial sentence or detention order for a maximum period of at least three years: \u2610 participation in a criminal organisation, \u2610 terrorism as defined in Annex 45 to the Agreement, \u2610 trafficking in human beings, \u2610 sexual exploitation of children and child pornography, \u2610 illicit trafficking in narcotic drugs and psychotropic substances, \u2610 illicit trafficking in weapons, munitions and explosives, \u2610 corruption, including bribery, \u2610 fraud, including that affecting the financial interests of the United Kingdom, of a Member State or of the Union, \u2610 laundering of the proceeds of crime, \u2610 counterfeiting of currency, \u2610 computer-related crime, \u2610 environmental crime, including illicit trafficking in endangered animal species and in endangered plant species and varieties, \u2610 facilitation of unauthorised entry and residence, \u2610 murder, grievous bodily injury, \u2610 illicit trade in human organs and tissue, \u2610 kidnapping, illegal restraint and hostage-taking, \u2610 racism and xenophobia, \u2610 organised or armed robbery, \u2610 illicit trafficking in cultural goods, including antiques and works of art, \u2610 swindling, \u2610 racketeering and extortion, \u2610 counterfeiting and piracy of products, \u2610 forgery of administrative documents and trafficking therein, \u2610 forgery of means of payment, \u2610 illicit trafficking in hormonal substances and other growth promoters, \u2610 illicit trafficking in nuclear or radioactive materials, \u2610 trafficking in stolen vehicles, \u2610 rape, \u2610 arson, \u2610 crimes within the jurisdiction of the International Criminal Court, \u2610 unlawful seizure of aircraft, ships or spacecraft, \u2610 sabotage. II. Full descriptions of offence(s) not covered by Section I above: (f) Other circumstances relevant to the case (optional information): (NB: This could cover remarks on extraterritoriality, interruption of periods of time limitation and other consequences of the offence) (g) This warrant pertains also to the seizure and handing over of property which may be required as evidence: This warrant pertains also to the seizure and handing over of property acquired by the requested person as a result of the offence: Description of the property (and location) (if known): (h) The offence(s) on the basis of which this warrant has been issued is (are) punishable by/has(have) led to a custodial life sentence or lifetime detention order: the issuing State will upon request by the executing State give an assurance that it will: \u2610 review the penalty or measure imposed \u2013 on request or at least after 20 years, and/or \u2610 encourage the application of measures of clemency to which the person is entitled to apply for under the law or practice of the issuing State, aiming at a non-execution of such penalty or measure. (i) The judicial authority which issued the warrant: Official name: Name of its representative: (2) Post held (title/grade): File reference: Address: Tel. No.: (country code) (area/city code) Fax No. (country code) (area/city code) E-mail: Contact details of the person to contact to make necessary practical arrangements for the surrender: Where a central authority has been made responsible for the transmission and administrative reception of arrest warrants: Name of the central authority: Contact person, if applicable (title/grade and name): Address: Tel. No.: (country code) (area/city code) Fax No. (country code) (area/city code) E-mail: Signature of the issuing judicial authority and/or its representative: Name: Post held (title/grade): Date: Official stamp (if available): (1) This warrant must be written in, or translated into, one of the official languages of the executing State, when that State is known, or any other language accepted by that State. (2) In the different language versions a reference to the \"holder\" of the judicial authority will be included. ANNEX 44 EXCHANGE OF CRIMINAL RECORD INFORMATION \u2013 TECHNICAL AND PROCEDURAL SPECIFICATIONS CHAPTER 1 GENERAL PROVISIONS Article 1 Objective The objective of this Annex is to lay down the necessary procedural and technical provisions for the implementation of Title IX of Part Three of this Agreement. Article 2 Communications network 1. The electronic exchange of information extracted from the criminal record between, on the one side, a Member State and, on the other side, the United Kingdom shall take place using a common communication infrastructure that provides for encrypted communications. 2. The common communication infrastructure shall be the Trans European Services for Telematics between Administrations (TESTA) communications network. Any further developments thereof or any alternative secure network shall ensure that the common communication infrastructure in place continues to fulfil the security requirements adequate for the exchange of criminal record information. Article 3 Interconnection software 1. The States shall use a standardised interconnection software enabling the connection of their central authorities to the common communication infrastructure in order to exchange the information extracted from the criminal record with the other States electronically in accordance with the provisions of Title IX of Part Three of this Agreement and this Annex. 2. For the Member States, the interconnection software shall be the ECRIS reference implementation software or their national ECRIS implementation software, if necessary adapted for the purposes of information exchange with the United Kingdom as set out in this Agreement. 3. The United Kingdom shall be responsible for the development and operation of its own interconnection software. For that purpose, at the latest before the entry into force of this Agreement, the United Kingdom shall ensure that its national interconnection software functions in accordance with the protocols and technical specifications established for the ECRIS reference implementation software, and with any further technical requirements established by eu-LISA. 4. The United Kingdom shall also ensure the implementation of any subsequent technical adaptations to its national interconnection software required by any changes to the technical specifications established for the ECRIS reference implementation software, or changes to any further technical requirements established by eu-LISA, without undue delay. To that end, the Union shall ensure that the United Kingdom is informed without undue delay of any planned changes to the technical specifications or requirements and is provided with any information necessary for the United Kingdom to comply with its obligations under this Annex. Article 4 Information to be transmitted in notifications, requests and replies 1. All notifications referred to in Article 646 of this Agreement shall include the following obligatory information: (a) information on the convicted person (full name, date of birth, place of birth (town and State), gender, nationality and \u2013 if applicable \u2013 previous name(s)); (b) information on the nature of the conviction (date of conviction, name of the court, date on which the decision became final); (c) information on the offence giving rise to the conviction (date of the offence underlying the conviction and name or legal classification of the offence as well as reference to the applicable legal provisions); and (d) information on the contents of the conviction (notably the sentence as well as any supplementary penalties, security measures and subsequent decisions modifying the enforcement of the sentence). 2. The following optional information shall be transmitted in notifications if that information has been entered in the criminal record (points (a) to (d)) or is available to the central authority (points (e) to (h)): (a) the convicted person's parents' names; (b) the reference number of the conviction; (c) the place of the offence; (d) disqualifications arising from the conviction; (e) the convicted person's identity number, or the type and number of the person's identification document; (f) fingerprints, which have been taken from that person; (g) if applicable, pseudonym and/or alias(es); (h) facial image. In addition, any other information concerning convictions entered in the criminal record may be transmitted. 3. All requests for information referred to in Article 648 of this Agreement shall be submitted in a standardised electronic format according to the model form set out in Chapter 2 of this Annex, in one of the official languages of the requested State. 4. All replies to requests referred to in Article 649 of this Agreement shall be submitted in a standardised electronic format in accordance with the model form set out in Chapter 2 of this Annex, and accompanied by a list of convictions, as provided for by national law. The requested State shall reply either in one of its official languages or in any other language accepted by both Parties. The United Kingdom, on the one side, and the Union, on behalf of any of its Member States, on the other side, may notify to the Specialised Committee on Law Enforcement and Judicial Cooperation which language(s) it accepts in addition to the official language(s) of that State. 5. The Specialised Committee on Law Enforcement and Judicial Cooperation shall adopt any modifications to the forms in Chapter 2 of this Annex referred to in paragraphs 3 and 4 as may be necessary. Article 5 Format of transmission of information 1. When transmitting information in accordance with Article 646 and Article 649 of this Agreement relating to the name or legal classification of the offence and to the applicable legal provisions, the States shall refer to the corresponding code for each of the offences referred to in the transmission, as provided for in the table of offences in Chapter 3 of this Annex. By way of exception, if the offence does not correspond to any specific sub-category, the \"open category\" code of the relevant or closest category of offences or, in the absence of the latter, an \"other offences\" code, shall be used for that particular offence. 2. The States may also provide available information relating to the level of completion and the level of participation in the offence and, if applicable, to the existence of total or partial exemption from criminal responsibility, or to recidivism. 3. When transmitting information in accordance with Article 646 and Article 649 of this Agreement relating to the contents of the conviction, notably the sentence as well as any supplementary penalties, security measures and subsequent decisions modifying the enforcement of the sentence, the States shall refer to the corresponding code for each of the penalties and measures referred to in the transmission, as provided for in the table of penalties and measures in Chapter 3 of this Annex. By way of exception, if the penalty or measure does not correspond to any specific sub-category, the \"open category\" code of the relevant or closest category of penalties and measures or, in the absence of the latter, an \"other penalties and measures\" code, shall be used for that particular penalty or measure. 4. The States shall also provide, if applicable, available information relating to the nature and/or conditions of execution of the penalty or measure imposed as provided for in the table of parameters of Chapter 3 of this Annex. The parameter \"non-criminal ruling\" shall be indicated only in cases where information on such a ruling is provided on a voluntary basis by the State of nationality of the person concerned, when replying to a request for information on convictions. 5. The following information shall be provided by the States to the Specialised Committee on Law Enforcement and Judicial Cooperation, with a view in particular to disseminating this information to other States: (a) the list of national offences in each of the categories referred to in the table of offences in Chapter 3 of this Annex. The list shall include the name or legal classification of the offence and reference to the applicable legal provisions. It may also include a short description of the constitutive elements of the offence; (b) the list of types of sentences, possible supplementary penalties and security measures and possible subsequent decisions modifying the enforcement of the sentence as defined in national law, in each of the categories referred to in the table of penalties and measures in Chapter 3 of this Annex. It may also include a short description of the specific penalty or measure. 6. The lists and descriptions referred to in paragraph 5 shall be regularly updated by the States. Updated information shall be sent to the Specialised Committee on Law Enforcement and Judicial Cooperation. 7. The Specialised Committee on Law Enforcement and Judicial Cooperation shall adopt any modifications to the tables in Chapter 3 of this Annex referred to in paragraphs 1 to 4 as may be necessary. Article 6 Continuity of transmission If the electronic mode of transmission of information is temporarily not available, the States shall transmit information by any means capable of producing a written record under conditions allowing the central authority of the requested State to establish the authenticity thereof, for the entire period of such unavailability. Article 7 Statistics and reporting 1. An evaluation of the electronic exchange of information extracted from criminal records pursuant to Title IX of Part Three of this Agreement shall be carried out on a regular basis. The evaluation shall be based on the statistics and reports of the respective States. 2. Each State shall compile statistics on the exchange generated by the interconnection software and shall forward them every month to the Specialised Committee on Law Enforcement and Judicial Cooperation and to eu-LISA. The States shall also provide the Specialised Committee on Law Enforcement and Judicial Cooperation and eu-LISA with the statistics on the number of nationals of other States convicted on their territory and on the number of such convictions. Article 8 Technical specifications The States shall observe common technical specifications on the electronic exchange of information extracted from the criminal record as provided by eu-LISA in the implementation of this Agreement and shall adapt their systems as appropriate without undue delay. CHAPTER 2 FORMS Request for information extracted from the criminal record (a) Information on the requesting State: State: Central authority(ies): Contact person: Telephone (with STD code): Fax (with STD code): E-mail address: Correspondence address: File reference, if known: (b) Information on the identity of the person concerned by the request( 1 ): Full name (forenames and all surnames) Previous names: Pseudonym and/or alias, if any: Gender: M \u2610 F \u2610 Nationality: Date of birth (in figures: dd/mm/yyyy): Place of birth (town and State): Father's name: Mother's name: Residence or known address: Person's identity number or type and number of the person's identification document: Fingerprints: Facial image: Other available identification information: (c) Purpose of the request: Please tick the appropriate box (1) \u2610 criminal proceedings (please identify the authority before which the proceedings are pending and, if available, the case reference number) \u2026 \u2026 (2) \u2610 request outside the context of criminal proceedings (please identify the authority before which the proceedings are pending and, if available, the case reference number, while ticking the relevant box): (i) \u2610 from a judicial authority \u2026 \u2026 (ii) \u2610 from a competent administrative authority \u2026 \u2026 (iii) \u2610 from the person concerned for information on own criminal record \u2026 \u2026 Purpose for which the information is requested: Requesting authority: \u2610 the person concerned does not consent for this information to be divulged (if the person concerned was asked for his or her consent in accordance with the law of the requesting State). Contact person for any further information needed: Name: Telephone: E-mail address: Other information (e.g. urgency of the request): Reply to the request Information relating to the person concerned Please tick the appropriate box The undersigned authority confirms that: \u2610 there is no information on convictions in the criminal record of the person concerned \u2610 there is information on convictions entered in the criminal record of the person concerned; a list of convictions is attached \u2610 there is other information entered in the criminal record of the person concerned; such information is attached (optional) \u2610 there is information on convictions entered in the criminal record of the person concerned but the convicting State intimated that the information about these convictions may not be retransmitted for any purposes other than that of criminal proceedings. The request for more information may be sent directly to \u2026 (please indicate the convicting State) \u2610 in accordance with the national law of the requested State, requests made for any purposes other than that of criminal proceedings may not be dealt with. Contact person for any further information needed: Name: Telephone: E-mail address: Other information (limitations of use of the data concerning requests outside the context of criminal proceedings): Please indicate the number of pages attached to the reply form: Done at on Signature and official stamp (if appropriate): Name and position/organisation: If appropriate, please attach a list of convictions and send the complete package to the requesting State. It is not necessary to translate the form or the list into the language of the requesting State. _______________ (1) To facilitate the identification of the person as much information as possible is to be provided. CHAPTER 3 STANDARISED FORMAT OF TRANSMISSION OF INFORMATION Common table of offences categories, with a table of parameters, referred to in Article 5(1) and (2) of Chapter 1 Code Categories and sub-categories of offences 0100 00 open category Crimes within the jurisdiction of the International Criminal Court 0101 00 Genocide 0102 00 Crimes against humanity 0103 00 War crimes 0200 00 open category Participation in a criminal organisation 0201 00 Directing a criminal organisation 0202 00 Knowingly taking part in the criminal activities of a criminal organisation 0203 00 Knowingly taking part in the non-criminal activities of a criminal organisation 0300 00 open category Terrorism 0301 00 Directing a terrorist group 0302 00 Knowingly participating in the activities of a terrorist group 0303 00 Financing of terrorism 0304 00 Public provocation to commit a terrorist offence 0305 00 Recruitment or training for terrorism 0400 00 open category Trafficking in human beings 0401 00 Trafficking in human beings for the purposes of labour or services exploitation 0402 00 Trafficking in human beings for the purposes of the exploitation of the prostitution of others or other forms of sexual exploitation 0403 00 Trafficking in human beings for the purposes of organ or human tissue removal 0404 00 Trafficking in human beings for the purposes of slavery, practices similar to slavery or servitude 0405 00 Trafficking in human beings for the purposes of labour or services exploitation of a minor 0406 00 Trafficking in human beings for the purposes of the exploitation of the prostitution of minors or other forms of their sexual exploitation 0407 00 Trafficking in human beings for the purposes of organ or human tissue removal of a minor 0408 00 Trafficking in human beings for the purposes of slavery, practices similar to slavery or servitude of a minor 0500 00 open category Illicit trafficking( 1 ) and other offences related to weapons, firearms, their parts and components, ammunition and explosives 0501 00 Illicit manufacturing of weapons, firearms, their parts and components, ammunition and explosives 0502 00 Illicit trafficking of weapons, firearms, their parts and components ammunition and explosives at national level( 2 ) 0503 00 Illicit exportation or importation of weapons, firearms, their parts and components, ammunition and explosives 0504 00 Unauthorised possession or use of weapons, firearms, their parts and components, ammunition and explosives 0600 00 open category Environmental crime 0601 00 Destroying or damaging protected fauna and flora species 0602 00 Unlawful discharges of polluting substances or ionising radiation into air, soil or water 0603 00 Offences related to waste, including hazardous waste 0604 00 Offences related to illicit trafficking( 1 ) in protected fauna and flora species or parts thereof 0605 00 Unintentional environmental offences 0700 00 open category Offences related to drugs or precursors, and other offences against public health 0701 00 Offences related to illicit trafficking( 3 ) in narcotic drugs, psychotropic substances and precursors not exclusively for own personal consumption 0702 00 Illicit consumption of drugs and their acquisition, possession, manufacture or production exclusively for own personal consumption 0703 00 Aiding or inciting others to use narcotic drugs or psychotropic substances illicitly 0704 00 Manufacture or production of narcotic drugs not exclusively for personal consumption 0800 00 open category Crimes against the person 0801 00 Intentional killing 0802 00 Aggravated cases of intentional killing( 4 ) 0803 00 Unintentional killing 0804 00 Intentional killing of a new-born by his/her mother 0805 00 Illegal abortion 0806 00 Illegal euthanasia 0807 00 Offences related to committing suicide 0808 00 Violence causing death 0809 00 Causing grievous bodily injury, disfigurement or permanent disability 0810 00 Unintentionally causing grievous bodily injury, disfigurement or permanent disability 0811 00 Causing minor bodily injury 0812 00 Unintentionally causing minor bodily injury 0813 00 Exposing to danger of loss of life or grievous bodily injury 0814 00 Torture 0815 00 Failure to offer aid or assistance 0816 00 Offences related to organ or tissue removal without authorisation or consent 0817 00 Offences related to illicit trafficking( 3 ) in human organs and tissue 0818 00 Domestic violence or threat 0900 00 open category Offences against personal liberty, dignity and other protected interests, including racism and xenophobia 0901 00 Kidnapping, kidnapping for ransom, illegal restraint 0902 00 Unlawful arrest or deprivation of liberty by public authority 0903 00 Hostage-taking 0904 00 Unlawful seizure of an aircraft or ship 0905 00 Insults, slander, defamation, contempt 0906 00 Threats 0907 00 Duress, pressure, stalking, harassment or aggression of a psychological or emotional nature 0908 00 Extortion 0909 00 Aggravated extortion 0910 00 Illegal entry into private property 0911 00 Invasion of privacy other than illegal entry into private property 0912 00 Offences against protection of personal data 0913 00 Illegal interception of data or communication 0914 00 Discrimination on grounds of gender, race, sexual orientation, religion or ethnic origin 0915 00 Public incitement to racial discrimination 0916 00 Public incitement to racial hatred 0917 00 Blackmail 1000 00 open category Sexual offences 1001 00 Rape 1002 00 Aggravated rape( 5 ) other than rape of a minor 1003 00 Sexual assault 1004 00 Procuring for prostitution or sexual act 1005 00 Indecent exposure 1006 00 Sexual harassment 1007 00 Soliciting by a prostitute 1008 00 Sexual exploitation of children 1009 00 Offences related to child pornography or indecent images of minors 1010 00 Rape of a minor 1011 00 Sexual assault of a minor 1100 00 open category Offences against family law 1101 00 Illicit sexual relations between close family members 1102 00 Polygamy 1103 00 Evading the alimony or maintenance obligation 1104 00 Neglect or desertion of a minor or a disabled person 1105 00 Failure to comply with an order to produce a minor or removal of a minor 1200 00 open category Offences against the State, public order, course of justice or public officials 1201 00 Espionage 1202 00 High treason 1203 00 Offences related to elections and referendum 1204 00 Attempt against life or health of the Head of State 1205 00 Insult of the State, Nation or State symbols 1206 00 Insult or resistance to a representative of public authority 1207 00 Extortion, duress, pressure towards a representative of public authority 1208 00 Assault or threat on a representative of public authority 1209 00 Public order offences, breach of the public peace 1210 00 Violence during sports events 1211 00 Theft of public or administrative documents 1212 00 Obstructing or perverting the course of justice, making false allegations in the course of criminal or judicial proceedings, perjury 1213 00 Unlawful impersonation of a person or an authority 1214 00 Escape from lawful custody 1300 00 open category Offences against public property or public interests 1301 00 Public, social security or family benefit fraud 1302 00 Fraud affecting European benefits or allowances 1303 00 Offences related to illegal gambling 1304 00 Obstructing of public tender procedures 1305 00 Active or passive corruption of a civil servant, a person holding public office or public authority 1306 00 Embezzlement, misappropriation or other diversion of property by a public official 1307 00 Abuse of a function by a public official 1400 00 open category Tax and customs offences 1401 00 Tax offences 1402 00 Customs offences 1500 00 open category Economic and trade related offences 1501 00 Bankruptcy or fraudulent insolvency 1502 00 Breach of accounting regulation, embezzlement, concealment of assets or unlawful increase in a company's liabilities 1503 00 Violation of competition rules 1504 00 Laundering of proceeds from crime 1505 00 Active or passive corruption in the private sector 1506 00 Revealing a secret or breaching an obligation of secrecy 1507 00 \"Insider trading\" 1600 00 open category Offences against property or causing damage to goods 1601 00 Unlawful appropriation 1602 00 Unlawful appropriation or diversion of energy 1603 00 Fraud, including swindling 1604 00 Dealing in stolen goods 1605 00 Illicit trafficking( 6 ) in cultural goods, including antiques and works of art 1606 00 Intentional damage or destruction of property 1607 00 Unintentional damage or destruction of property 1608 00 Sabotage 1609 00 Offences against industrial or intellectual property 1610 00 Arson 1611 00 Arson causing death or injury to persons 1612 00 Forest arson 1700 00 open category Theft offences 1701 00 Theft 1702 00 Theft after unlawful entry into property 1703 00 Theft, using violence or weapons, or using threat of violence or weapons against person 1704 00 Forms of aggravated theft which do not involve use of violence or weapons, or use of threat of violence or weapons, against persons. 1800 00 open category Offences against information systems and other computer-related crime 1801 00 Illegal access to information systems 1802 00 Illegal system interference 1803 00 Illegal data interference 1804 00 Production, possession, dissemination of or trafficking in computer devices or data enabling commitment of computer-related offences 1900 00 open category Forgery of means of payment 1901 00 Counterfeiting or forging currency 1902 00 Counterfeiting of non-cash means of payment 1903 00 Counterfeiting or forging public fiduciary documents 1904 00 Putting into circulation/using counterfeited or forged currency, non-cash means of payment or public fiduciary documents 1905 00 Possession of a device for the counterfeiting or forgery of currency or public fiduciary documents 2000 00 open category Falsification of documents 2001 00 Falsification of a public or administrative document by a private individual 2002 00 Falsification of a document by a civil servant or a public authority 2003 00 Supply or acquisition of a forged public or administrative document; supply or acquisition of a forged document by a civil servant or a public authority 2004 00 Using forged public or administrative documents 2005 00 Possession of a device for the falsification of public or administrative documents 2006 00 Forgery of private documents by a private individual 2100 00 open category Offences against traffic regulations 2101 00 Dangerous driving 2102 00 Driving under the influence of alcohol or narcotic drugs 2103 00 Driving without a licence or while disqualified 2104 00 Failure to stop after a road accident 2105 00 Avoiding a road check 2106 00 Offences related to road transport 2200 00 open category Offences against labour law 2201 00 Unlawful employment 2202 00 Offences relating to remuneration, including social security contributions 2203 00 Offences relating to working conditions, health and safety at work 2204 00 Offences relating to access to or exercise of a professional activity 2205 00 Offences relating to working hours and rest time 2300 00 open category Offences against migration law 2301 00 Unauthorised entry or residence 2302 00 Facilitation of unauthorised entry and residence 2400 00 open category Offences against military obligations 2500 00 open category Offences related to hormonal substances and other growth promoters 2501 00 Illicit importation, exportation or supply of hormonal substances and other grown promoters 2600 00 open category Offences related to nuclear materials or other hazardous radioactive substances 2601 00 Illicit importation, exportation, supply or acquisition of nuclear or radioactive materials 2700 00 open category Other offences 2701 00 Other intentional offences 2702 00 Other unintentional offences _______________ (1) Unless otherwise specified in this category, \"trafficking\" means import, export, acquisition, sale, delivery, movement or transfer. (2) For the purposes of this sub-category trafficking includes acquisition, sale, delivery, movement or transfer. (3) For the purposes of this sub-category trafficking includes import, export, acquisition, sale, delivery, movement or transfer. (4) For example: particularly grave circumstances. (5) For example rape with particular cruelty. (6) Trafficking includes import, export, acquisition, sale, delivery, movement or transfer. Parameters Level of completion: Completed act C Attempt or preparation A Non-transmitted element \u00d8 Level of participation: Perpetrator M Aider and abettor or instigator/organiser, conspirator H Non-transmitted element \u00d8 Exemption from criminal responsibility: Insanity or diminished responsibility S Recidivism R Common table of penalties and measures categories, with a table of parameters, referred to in Article 5(3) and (4) of Chapter 1 Code Categories and sub-categories of penalties and measures 1000 open category Deprivation of freedom 1001 Imprisonment 1002 Life imprisonment 2000 open category Restriction of personal freedom 2001 Prohibition from frequenting some places 2002 Restriction to travel abroad 2003 Prohibition to stay in some places 2004 Prohibition from entry to a mass event 2005 Prohibition to enter in contact with certain persons through whatever means 2006 Placement under electronic surveillance( 1 ) 2007 Obligation to report at specified times to a specific authority 2008 Obligation to stay/reside in a certain place 2009 Obligation to be at the place of residence on the set time 2010 Obligation to comply with the probation measures ordered by the court, including the obligation to remain under supervision 3000 open category Prohibition of a specific right or capacity 3001 Disqualification from function 3002 Loss/suspension of capacity to hold or to be appointed to public office 3003 Loss/suspension of the right to vote or to be elected 3004 Incapacity to contract with public administration 3005 Ineligibility to obtain public subsidies 3006 Cancellation of the driving licence( 2 ) 3007 Suspension of driving licence 3008 Prohibition to drive certain vehicles 3009 Loss/suspension of the parental authority 3010 Loss/suspension of right to be an expert in court proceedings/witness under oath/juror 3011 Loss/suspension of right to be a legal guardian( 3 ) 3012 Loss/suspension of right of decoration or title 3013 Prohibition to exercise professional, commercial or social activity 3014 Prohibition from working or activity with minors 3015 Obligation to close an establishment 3016 Prohibition to hold or to carry weapons 3017 Withdrawal of a hunting/fishing license 3018 Prohibition to issue cheques or to use payment/credit cards 3019 Prohibition to keep animals 3020 Prohibition to possess or use certain items other than weapons 3021 Prohibition to play certain games/sports 4000 open category Prohibition or expulsion from territory 4001 Prohibition from national territory 4002 Expulsion from national territory 5000 open category Personal obligation 5001 Submission to medical treatment or other forms of therapy 5002 Submission to a social-educational programme 5003 Obligation to be under the care/control of the family 5004 Educational measures 5005 Socio-judicial probation 5006 Obligation of training/working 5007 Obligation to provide judicial authorities with specific information 5008 Obligation to publish the judgment 5009 Obligation to compensate for the prejudice caused by the offence 6000 open category Penalty on personal property 6001 Confiscation 6002 Demolition 6003 Restoration 7000 open category Placing in an institution 7001 Placing in a psychiatric institution 7002 Placing in a detoxification institution 7003 Placing in an educational institution 8000 open category Financial penalty 8001 Fine 8002 Day-fine( 4 ) 8003 Fine for the benefit of a special recipient( 5 ) 9000 open category Working penalty 9001 Community service or work 9002 Community service or work accompanied with other restrictive measures 10000 open category Military penalty 10001 Loss of military rank( 6 ) 10002 Expulsion from professional military service 10003 Military imprisonment 11000 open category Exemption/deferment of sentence/penalty, warning 12000 open category Other penalties and measures Parameters (to be specified where applicable) \u00f8 Penalty m Measure a Suspended penalty/measure b Partially suspended penalty/measure c Suspended penalty/measure with probation/supervision d Partially suspended penalty/measure with probation/supervision e Conversion of penalty/measure f Alternative penalty/measure imposed as principal penalty g Alternative penalty/measure imposed initially in case of non-respect of the principal penalty h Revocation of suspended penalty/measure i Subsequent formation of an overall penalty j Interruption of enforcement/postponement of the penalty/measure( 7 ) k Remission of the penalty l Remission of the suspended penalty n End of penalty o Pardon p Amnesty q Release on parole (liberation of a person before end of the sentence under certain conditions) r Rehabilitation (with or without the deletion of penalty from criminal records) s Penalty or measure specific to minors t Non-criminal ruling( 8 ) _______________ (1) Fixed or mobile placement. (2) Reapplication in order to obtain a new driving licence is necessary. (3) Legal guardian for a person who is legally incompetent or for a minor. (4) Fine expressed in daily units. (5) E.g.: for an institution, association, foundation or a victim. (6) Military demotion. (7) Does not lead to avoidance of enforcement of penalty. (8) This parameter will be indicated only when such information is provided in reply to the request received by the State of nationality of the person concerned. ANNEX 45 DEFINITION OF TERRORISM 1. Scope For the purposes of Title IX of Part Three, point (b) of Article 599(3), Article 599(4), point (c) of Article 602(2) and point (a) of Article 670(2) of this Agreement, Annex 43 and Annex 46,\"terrorism\" means the offences as defined in paragraphs 3 to 14 of this Annex. 2. Definitions of terrorist group and structured group 2.1 \"Terrorist group\" means a structured group of more than two persons, established for a period of time and acting in concert to commit terrorist offences. 2.2 \"Structured group\" means a group that is not randomly formed for the immediate commission of an offence and that does not need to have formally defined roles for its members, continuity of its membership or a developed structure. 3. Terrorist offences 3.1 Intentional acts, as defined as offences under domestic law, which, given their nature or context may seriously damage a country or an international organisation where committed with one of the aims listed in paragraph 3.2: (a) attacks upon a person's life which may cause death; (b) attacks upon the physical integrity of a person; (c) kidnapping or hostage-taking; (d) causing extensive destruction to a government or public facility, a transport system, an infrastructure facility, including an information system, a fixed platform located on the continental shelf, a public place or private property likely to endanger human life or result in major economic loss; (e) seizure of aircraft, ships or other means of public or goods transport; (f) manufacture, possession, acquisition, transport, supply or use of explosives or weapons, including chemical, biological, radiological or nuclear weapons, as well as research into, and development of, chemical, biological, radiological or nuclear weapons; (g) release of dangerous substances, or causing fires, floods or explosions, the effect of which is to endanger human life; (h) interfering with or disrupting the supply of water, power or any other fundamental natural resource, the effect of which is to endanger human life; (i) seriously hindering or interrupting the functioning of an information system by inputting computer data, by transmitting, damaging, deleting, deteriorating, altering or suppressing such data, or by rendering such data inaccessible, intentionally and without right, in cases where: (i) a significant number of information systems have been affected through the use of a tool designed or adapted primarily for that purpose; (ii) the offence causes serious damage; (iii) the offence is committed against a critical infrastructure information system; (j) deleting, damaging, deteriorating, altering or suppressing computer data on an information system, or rendering such data inaccessible, intentionally and without right, in cases where the offence is committed against a critical infrastructure information system; (k) threatening to commit any of the acts listed in points (a) to (j). 3.2 The aims referred to in paragraph 3.1 are: (a) seriously intimidating a population; (b) unduly compelling a government or an international organisation to perform or abstain from performing any act; (c) seriously destabilising or destroying the fundamental political, constitutional, economic or social structures of a country or an international organisation. 4. Offences relating to a terrorist group The following intentional acts: (a) directing a terrorist group; (b) participating in the activities of a terrorist group, including by supplying information or material resources, or by funding its activities in any way, with knowledge of the fact that such participation will contribute to the criminal activities of the terrorist group. 5. Public provocation to commit a terrorist offence The distribution, or otherwise making available by any means, whether online or offline, of a message to the public, with the intent to incite the commission of one of the offences listed in points (a) to (j) of paragraph 3.1 where such conduct, directly or indirectly, such as by the glorification of terrorist acts, advocates the commission of terrorist offences, thereby causing a danger that one or more such offences may be committed when committed intentionally. 6. Recruitment for terrorism Soliciting another person to commit or contribute to the commission of one of the offences listed in points (a) to (j) of paragraph 3.1, or in paragraph 4 when committed intentionally. 7. Providing training for terrorism Providing instruction on the making or use of explosives, firearms or other weapons or noxious or hazardous substances, or on other specific methods or techniques, for the purpose of committing, or contributing to the commission of, one of the offences listed in points (a) to (j) of paragraph 3.1, knowing that the skills provided are intended to be used for this purpose when committed intentionally. 8. Receiving training for terrorism Receiving instruction on the making or use of explosives, firearms or other weapons or noxious or hazardous substances, or on other specific methods or techniques, for the purpose of committing, or contributing to the commission of, one of the offences listed in points (a) to (j) of paragraph 3.1 when committed intentionally. 9. Travelling for the purpose of terrorism 9.1 Travelling to a country other than that State for the purpose of committing, or contributing to the commission of, a terrorist offence as referred to in paragraph 3, for the purpose of the participation in the activities of a terrorist group with knowledge of the fact that such participation will contribute to the criminal activities of such a group as referred to in paragraph 4, or for the purpose of providing or receiving training for terrorism as referred to in paragraphs 7 and 8 when committed intentionally. 9.2 In addition, the following conduct when committed intentionally: (a) travelling to that State for the purpose of committing, or contributing to the commission of, a terrorist offence as referred to in paragraph 3, for the purpose of the participation in the activities of a terrorist group with knowledge of the fact that such participation will contribute to the criminal activities of such a group as referred to in paragraph 4, or for the purpose of providing or receiving training for terrorism as referred to in paragraphs 7 and 8; or (b) preparatory acts undertaken by a person entering that State with the intention to commit, or contribute to the commission of, a terrorist offence as referred to in paragraph 3.1. 10. Organising or otherwise facilitating travelling for the purpose of terrorism Any act of organisation or facilitation that assists any person in travelling for the purpose of terrorism, as referred to in paragraph 9.1 and point (a) of paragraph 9.2, knowing that the assistance thus rendered is for that purpose when committed intentionally. 11. Terrorist financing 11.1 Providing or collecting funds, by any means, directly or indirectly, with the intention that they be used, or in the knowledge that they are to be used, in full or in part, to commit, or to contribute to the commission of, any of the offences referred to in paragraphs 3 to 10 when committed intentionally. 11.2 Where the terrorist financing referred to in paragraph 11.1 concerns any of the offences laid down in paragraphs 3, 4 and 9, it shall not be necessary that the funds be in fact used, in full or in part, to commit, or to contribute to the commission of, any of those offences, nor shall it be required that the offender knows for which specific offence or offences the funds are to be used. 12. Other offences related to terrorist activities The following intentional acts: (a) aggravated theft with a view to committing one of the offences listed in paragraph 3; (b) extortion with a view to committing one of the offences listed in paragraph 3; (c) drawing up or using false administrative documents with a view to committing one of the offences listed points (a) to (j) of paragraph 3.1, point (b) of paragraph 4, and paragraph 9. 13. Relationship to terrorist offences For an offence referred to in paragraphs 4 to 12 to be considered terrorism as referred to in paragraph 1, it shall not be necessary that a terrorist act be actually committed, nor shall it be necessary, insofar as the offences referred to in paragraphs 5 to 10 and 12 are concerned, to establish a link to another specific offence laid down in this Annex. 14. Aiding and abetting, inciting and attempting The following acts: (a) aiding and abetting an offence referred to in paragraphs 3 to 8, 11 and 12; (b) inciting an offence referred to in paragraphs 3 to 12; and (c) attempting to commit an offence referred to in paragraphs 3, 6 and 7, paragraph 9.1, point (a) of paragraph 9.2, and paragraphs 11 and 12, with the exception of possession as provided for in point (f) of paragraph 3.1 and the offence referred to in point (k) of paragraph 3.1. ANNEX 46 FREEZING AND CONFISCATION Freezing / Provisional Measures Request Form SECTION A Requesting State: \u2026 Requested State: \u2026 SECTION B: Urgency Grounds for urgency and/or requested date of execution: Time limits for execution of the freezing request are set out in Article 663 of the Agreement. However, if a shorter or specific time limit is necessary, please provide the date and explain the reason for this: SECTION C: Relevant persons State all information, as far as known, regarding the identity of the (1) natural or (2) legal person(s) concerned in the freezing request or of the person(s) that owns/own the property that is covered by the freezing request (if more than one person is concerned, please provide the information for each person): 1. Natural person: Name: First name(s): Other relevant name(s), if applicable: Aliases, if applicable: Sex: Nationality: Identity number or social security number: Type and number of the identity document(s) (ID card, passport), if available: Date of birth: Place of birth: Residence and/or known address; if address not known, state the last known address: Language(s) which the person understands: Please indicate whether this person has the freezing request directed against him or her or owns the property that is covered by the freezing request: 2. Legal person: Name: Form of legal person: Shortened name, commonly used name or trading name, if applicable: Registered seat: Registration number: Address of the legal person: Name of the legal person's representative: Please indicate whether this legal person has the freezing request directed against it or owns the property that is covered by the freezing request: If different from the address above, please give the location where the freezing measure is to be carried out: 3. Third parties: (i) Third parties whose rights in relation to the property that is covered by the freezing request are directly prejudiced by the request (identity and grounds), if applicable: (ii) In case third parties have had the opportunity to claim rights, attach documents demonstrating that this has been the case. 4. Provide any other information that will assist with the execution of the freezing request: SECTION D: Relevant Property State all information, as far as known, regarding the assets subject of the freezing request. Please provide details of all property and individual items where applicable: 1. If relating to an amount of money: (i) Grounds for believing that the person has property/income in the requested State (ii) Description and location of the property/source of income of that person (iii) Exact location of the property/source of income of that person (iv) Details of the bank account of that person (if known) 2. If the freezing request concerns specific item(s) of property (or property of equivalent value to such property): (i) Grounds for believing that the specific item(s) of property is located in the requested State (ii) Description and location of the specific item(s) of property (iii) Other relevant information 3. Total amount requested for freezing or execution in the requested State (in figures and words, indicate currency): SECTION E: Grounds for request or issuing freezing order (if applicable) Summary of the facts: 1. Set out the reasons for the freezing request or why the order has been issued, including a summary of the underlying facts and grounds for freezing, a description of the criminal offence(s) charged, under investigation or subject to proceedings, the stage the investigation or proceedings have reached, the reasons for any risk factors and any other relevant information. 2. Nature and legal classification of the criminal offence(s) in relation to which the freezing request relates or the order was issued and the applicable legal provision(s). 3. The following applies only in the case(s) where both the requesting and requested State have made a notification under Article 670(2) of the Agreement: if applicable, tick one or more of the following offences, as defined by the law of the requesting State, punishable in the requesting State by a custodial sentence or detention order for a maximum period of at least three years. Where the freezing request or order concerns several criminal offences, please indicate numbers in the list of criminal offences below (corresponding to the criminal offences as described under points 1 and 2 above): \u2610 participation in a criminal organisation \u2610 terrorism as defined in Annex 45 \u2610 trafficking in human beings \u2610 sexual exploitation of children and child pornography \u2610 illicit trafficking in narcotic drugs and psychotropic substances \u2610 illicit trafficking in weapons, munitions and explosives \u2610 corruption, including bribery \u2610 fraud, including that affecting the financial interests of the United Kingdom, a Member State or the Union \u2610 laundering of the proceeds of crime \u2610 counterfeiting currency \u2610 computer-related crime \u2610 environmental crime, including illicit trafficking in endangered animal species and endangered plant species and varieties \u2610 facilitation of unauthorised entry and residence \u2610 murder \u2610 grievous bodily injury \u2610 illicit trade in human organs and tissue \u2610 kidnapping, illegal restraint and hostage-taking \u2610 racism and xenophobia \u2610 organised or armed robbery \u2610 illicit trafficking in cultural goods, including antiques and works of art \u2610 swindling \u2610 racketeering and extortion \u2610 counterfeiting and piracy of products \u2610 forgery of administrative documents and trafficking therein \u2610 forgery of means of payment \u2610 illicit trafficking in hormonal substances and other growth promoters \u2610 illicit trafficking in nuclear or radioactive materials \u2610 trafficking in stolen vehicles \u2610 rape \u2610 arson \u2610 crimes within the jurisdiction of the International Criminal Court \u2610 unlawful seizure of aircraft, ships or spacecraft \u2610 sabotage 4. Any other relevant information (e.g. relation between the property and the criminal offence): SECTION F: Confidentiality \u2610 Need to maintain the information in the request confidential after execution: \u2610 Need for specific formalities at the time of execution: SECTION G: Requests to more than one State Where a freezing request has been transmitted to more than one State, provide the following information: 1. A freezing request has been transmitted to the following other State(s) (State and authority): 2. Please indicate the reasons for transmitting freezing requests to multiple States: 3. Value of assets, if known, in each requested State: 4. Please indicate any specific needs: SECTION H: Relation to earlier freezing requests or orders If applicable, provide information relevant to identify previous or related freezing requests: 1. Date of request or issue and transmission of order: 2. Authority to which it was transmitted: 3. Reference given by the issuing and executing authorities: SECTION I: Confiscation This freezing request is accompanied by a confiscation order issued in the requesting State (reference number of the confiscation order): \u2610 Yes, reference number: \u2610 No The property shall remain frozen in the requested State pending the transmission and execution of the confiscation order (estimated date for submission of the confiscation order, if possible): SECTION J: Legal remedies (if applicable) Please indicate if a legal remedy can be sought in the requesting State against the issuing of a freezing request/order, and if so please provide further details (description of the legal remedy, including necessary steps to take and deadlines): SECTION K: Issuing Authority If there is a freezing order in the requesting state upon which this freezing request is based, please provide the following details: 1. Type of issuing authority: \u2610 judge, court, public prosecutor \u2610 another competent authority designated by the requesting State 2. Contact details: Official name of the issuing authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the issuing authority: Signature of the issuing authority and/or its representative certifying the content of the Freezing/Provisional Measures Request Form as accurate and correct: Name: Post held (title/grade): Date: Official stamp (if available): SECTION L: Validating Authority Please indicate the type of authority which has validated the Freezing/Provisional Measures Request Form, if applicable: \u2610 judge, court, public prosecutor \u2610 another competent authority designated by the requesting State Official name of the validating authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the competent authority: SECTION M: Central Authority Please indicate the central authority responsible for the administrative transmission and receipt of freezing requests in the requesting State: Official name of the central authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the competent authority: SECTION N: Further information 1. Please indicate if the main contact point in the requesting State should be the: \u2610 issuing authority \u2610 competent authority \u2610 central authority 2. If different from above, please provide the contact details of the person(s) to contact for additional information regarding this freezing request: Name/Title/Organisation: Address: E-mail/Contact Phone No: SECTION O: Annexes The original or duly authenticated copy of the freezing order must be provided with the Freezing/Provisional Measures Request Form if a freezing order has been issued in the requesting State. Confiscation Request Form SECTION A Requesting State: \u2026 Requested State: \u2026 SECTION B: Confiscation order Date of issue: \u2026 Date order became final: \u2026 Reference number: \u2026 Total amount of order in figures and words, indicate currency Amount requested for execution in requested State, or if specific type(s) of property, description and location of property Please provide details of the court findings in relation to the confiscation order: \u2610 property is the proceeds of an offence, or equivalent to the full or part of the value of such proceeds \u2610 property constitutes instrumentalities of such an offence \u2610 property is liable to extended confiscation \u2610 property is subject to confiscation under any other provisions relating to powers of confiscation, including confiscation without a final conviction, under the law of the requesting State following proceedings in relation to a criminal offence SECTION C: Affected persons State all information, as far as known, regarding the identity of the (1) natural or (2) legal person(s) affected by the confiscation request (if more than one person is concerned, please provide the information for each person): 1. Natural person: Name: First name(s): Other relevant name(s), if applicable: Aliases, if applicable: Sex: Nationality: Identity number or social security number: Type and number of the identity document(s) (ID card, passport), if available: Date of birth: Place of birth: Residence and/or known address; if address not known, state the last known address: Language(s) which the person understands: Please indicate whether this person has the confiscation request directed against him or her or owns the property that is covered by the confiscation request: 2. Legal person: Name: Form of legal person: Shortened name, commonly used name or trading name, if applicable: Registered seat: Registration number: Address of the legal person: Name of the legal person's representative: If different from the address above, please give the location where the confiscation request is to be carried out: 3. Third parties: (i) Third parties whose rights in relation to the property that is covered by the confiscation request are directly prejudiced by the request (identity and grounds), if known/applicable: (ii) In case third parties have had the opportunity to claim rights, attach documents demonstrating that this has been the case. 4. Provide any other information that will assist with the execution of the confiscation request: SECTION D: Affected Property State all information, as far as known, regarding the assets subject to the confiscation. Please provide details of all property and individual items where applicable: 1. If relating to amount of money: (i) Grounds for believing that the person has property/income in the requested State: (ii) Description and location of the property/source of income: 2. If the request concerns specific item(s) of property: (i) Grounds for believing that the specific item(s) of property is/are located in the requested State: (ii) Description and location of the specific item(s) of property: 3. Value of property: (i) Total amount of request (approximate amount): (ii) Total amount requested for execution in the requested State (approximate amount): (iii) If specific type(s) of property, description and location of property: SECTION E: Grounds for confiscation Summary of the facts: 1. Set out the reasons why a confiscation order has been issued, including a summary of the underlying facts and grounds for confiscation, a description of offences, the reasons for any risk factors and any other relevant information (such as date, place and circumstances of the offence): 2. Nature and legal classification of the offence(s) in relation to which the confiscation order was issued and the applicable legal provision(s): 3. The following applies only in the case where both the requesting and requested State have made a notification under Article 670(2) of the Agreement: if applicable, tick one or more of the following offences, as defined by the law of the requesting State, punishable in the requesting State by a custodial sentence or detention order for a maximum period of at least three years. Where the confiscation order concerns several criminal offences, please indicate numbers in the list of criminal offences below (corresponding to the criminal offences as described under points 1 and 2 above): \u2610 participation in a criminal organisation \u2610 terrorism as defined in Annex 45 \u2610 trafficking in human beings \u2610 sexual exploitation of children and child pornography \u2610 illicit trafficking in narcotic drugs and psychotropic substances \u2610 illicit trafficking in weapons, munitions and explosives \u2610 corruption, including bribery \u2610 fraud, including that affecting the financial interests of the United Kingdom, a Member State or the Union \u2610 laundering of the proceeds of crime \u2610 counterfeiting currency \u2610 computer-related crime \u2610 environmental crime, including illicit trafficking in endangered animal species and endangered plant species and varieties \u2610 facilitation of unauthorised entry and residence \u2610 murder \u2610 grievous bodily injury \u2610 illicit trade in human organs and tissue \u2610 kidnapping, illegal restraint and hostage-taking \u2610 racism and xenophobia \u2610 organised or armed robbery \u2610 illicit trafficking in cultural goods, including antiques and works of art \u2610 swindling \u2610 racketeering and extortion \u2610 counterfeiting and piracy of products \u2610 forgery of administrative documents and trafficking therein \u2610 forgery of means of payment \u2610 illicit trafficking in hormonal substances and other growth promoters \u2610 illicit trafficking in nuclear or radioactive materials \u2610 trafficking in stolen vehicles \u2610 rape \u2610 arson \u2610 crimes within the jurisdiction of the International Criminal Court \u2610 unlawful seizure of aircraft, ships or spacecraft \u2610 sabotage 4. Any other relevant information (e.g. relation between the property and the criminal offence): SECTION F: Confidentiality \u2610 Need to maintain the information in the request or part of it confidential Please indicate any relevant information: SECTION G: Requests to more than one State Where a confiscation request has been transmitted to more than one State, provide the following information: 1. A confiscation request has been transmitted to the following other State(s) (State and authority): 2. Reasons for transmitting confiscation request to multiple States (select appropriate reasons): (i) If a request concerns specific items of property: \u2610 Different items of property covered by the request are believed to be located in different States \u2610 The confiscation request relates to a specific item of property and requires action in more than one State (ii) If the confiscation request concerns an amount of money: \u2610 The estimated value of the property which may be confiscated in the requesting State and in any one requested State is not likely to be sufficient to cover the full amount set out in the order \u2610 Other specific needs: 3. Value of assets, if known, in each requested State: 4. If confiscation of the specific item(s) of property requires action in more than one State, description of the action to be taken in the requested State: SECTION H: Conversion and transfer of property 1. If the confiscation request concerns a specific item of property, confirm whether the requesting State allows for the confiscation in the requested State to take the form of a requirement to pay a sum of money corresponding to the value of the property: \u2610 Yes \u2610 No 2. If the confiscation concerns an amount of money, state whether property, other than money obtained from the execution of the confiscation request, may be transferred to the requesting State: \u2610 Yes \u2610 No SECTION I: Imprisonment in default or other measures restricting the liberty of a person Please indicate whether the requesting State allows for the application by the requested State of imprisonment in default or other measures restricting the liberty of a person where it is not possible to execute the confiscation request, either wholly or partially: \u2610 Yes \u2610 No SECTION J: Restitution or victim compensation 1. Please indicate, where relevant: \u2610 An issuing authority or another competent authority of the requesting State has issued a decision to compensate the victim with, or restitute to the victim, the following sum of money: \u2610 An issuing authority or another competent authority of the requesting State has issued a decision to restitute the following property other than money to the victim: 2. Details of the decision to restitute property to, or compensate, the victim: Issuing authority (official name): Date of the decision: Reference number of the decision (if available): Description of the property to be restituted or amount awarded in compensation: Name of the victim: Address of the victim: SECTION K: Legal remedies Please indicate if a legal remedy has already been sought against the issuing of a confiscation order, and if so please provide further details (description of the legal remedy, including necessary steps to take and deadlines): SECTION L: Issuing Authority Please provide details on the authority which issued the confiscation request in the requesting State: 1. Type of the issuing authority: \u2610 judge, court, public prosecutor \u2610 another competent authority designated by the requesting State 2. Contact details: Official name of the issuing authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the issuing authority: Signature of the issuing authority and/or its representative certifying the content of the Confiscation Request Form as accurate and correct: Name: Post held (title/grade): Date: Official stamp (if available): SECTION M: Validating Authority Please indicate the type of authority which has validated the Confiscation Request Form, if applicable: \u2610 judge, court, public prosecutor \u2610 another competent authority designated by the issuing State Official name of the validating authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the competent authority: SECTION N: Central Authority Please indicate the central authority responsible for the administrative transmission and receipt of the Confiscation Request Form in the requesting State: Official name of the central authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the competent authority: SECTION O: Further information 1. Please indicate if the main contact point in the requesting State should be the: \u2610 issuing authority \u2610 competent authority \u2610 central authority 2. If different from above, please provide the contact details of the person(s) to contact for additional information regarding this Confiscation Request Form: Name/ Title/ Organisation: Address: E-mail/Contact Phone No: SECTION P: Annexes The original or duly authenticated copy of the confiscation order must be provided with the Confiscation Request Form. ANNEX 47 IMPLEMENTATION OF THE FINANCIAL CONDITIONS 1. The Commission shall communicate to the United Kingdom, as soon as possible and at the latest on 16 April of the financial year, the following information for each Union programme, activity, or part thereof, in which the United Kingdom participates: (a) the amounts in commitment appropriations in the Union budget definitively adopted for the year in question for the budget lines covering participation of the United Kingdom in accordance with the Protocol referred to in Article 710 of this Agreement and, if relevant, the amount of external assigned revenue appropriations that do not result from financial contribution from other donors on these budget lines; (b) the amount of the participation fee referred to in Article 714(4) of this Agreement; (c) from year N + 1 of implementation of a programme included in the Protocol referred to in Article 710 of this Agreement, the implementation of commitment appropriations corresponding to budgetary year N and the level of decommitment; (d) for programmes to which Article 716 of this Agreement applies, for the part of the programmes where such information is necessary to calculate the automatic correction, the level of commitments entered into in favour of United Kingdom entities broken down according to the corresponding year of budgetary appropriations and the related total level of commitments. On the basis of its Draft Budget, the Commission shall provide an estimate of information under points (a) and (b) as soon as possible, and, at the latest, by 1 September of the financial year. 2. The Commission shall issue, at the latest on 16 April and on 16 July of each financial year, a call for funds to the United Kingdom that corresponds to the contribution of the United Kingdom under this Agreement for each of the programmes, activities, or parts thereof, in which the United Kingdom participates. 3. The United Kingdom shall pay the amount indicated in the call for funds at the latest 60 days after the call for funds is issued. The United Kingdom may make separate payments for each programme and activity. 4. By derogation from paragraphs 2 and 3, for the year 2021 in which the Protocol referred to in Article 710 of this Agreement is concluded, the Commission shall issue a call for funds at the latest on 16 April 2021 if the Protocol is signed on or before 31 March 2021, or at the latest on the 16th of the month following the month in which the Protocol was signed if it is signed after 31 March 2021. If that call for funds is issued after 16 July of the year in question, there shall be a single call for funds for this year. The United Kingdom shall pay the amount indicated in the call for funds at the latest 60 days after the call for funds is issued. The United Kingdom may make separate payments for each programme and activity. 5. The call for funds for a given year shall have the value established by dividing the annual amount calculated in application of Article 714 of this Agreement, including any adjustment under Article 714(8), Article 716 or 717 of this Agreement, by the number of calls for funds for that year pursuant to paragraphs 2 and 4 of this Annex. 6. By way of derogation from paragraph 5, in relation to the contribution to Horizon Europe for the multiannual financial framework 2021-2027, the call for funds for a given year N shall have the value established by dividing: (a) the annual amount calculated (i) by applying the following payment schedule for payments if year N is: \u2014 2021: 50 % paid in 2021, 50 % paid in 2026 \u2014 2022: 50 % paid in 2022, 50 % paid in 2027 (ii) on the amount resulting from the application of Articles 714 and 716 of this Agreement, including any adjustment under Article 714(8) or Article 716 of this Agreement for that year N, by (b) the number of calls for funds for that year N pursuant to paragraphs 2 and 4: The application of this paragraph has no bearing on establishing the calculation of the automatic correction under Articles 716 and 721. For all the calculations of other amounts related to Part V of this Agreement, the annual contribution of the United Kingdom shall take into account this paragraph . 7. Where the participation of the United Kingdom is terminated pursuant to Article 719 or Article 720 of this Agreement any payments in relation to the period before the termination takes effect, which were postponed in accordance with paragraph 6 of this Annex, shall become due. The Commission shall issue a call for funds in relation to the amount due at the latest one month after the termination takes effect. The United Kingdom shall pay this due amount within 60 days of the issue of the call for funds. 8. The Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (1) (\"Financial Regulation\") applicable to the general budget of the European Union shall apply to the management of the appropriations. 9. In the absence of payment by the United Kingdom by the due date, the Commission shall send a formal letter of reminder. Any delay in the payment of the contribution shall give rise to the payment of default interest by the United Kingdom on the outstanding amount as from the due date until the day on which that outstanding amount is paid in full. The interest rate for amounts receivable but not paid on the due date shall be the rate applied by the European Central Bank to its principal refinancing operations, as published in the C series of the Official Journal of the European Union, in force on the first day of the month in which the due date falls, or 0 per cent, whichever is higher, plus three and a half percentage points. (1) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ EU L 193, 30.7.2018, p. 1). ANNEX 48 RULES OF PROCEDURE FOR DISPUTE SETTLEMENT I. Definitions 1. For the purposes of Title I of Part Six of this Agreement and of these Rules of Procedure, the following definitions apply: (a) \"administrative staff\", in respect of an arbitrator, means individuals under the direction and control of an arbitrator, other than assistants; (b) \"adviser\" means an individual retained by a Party to advise or assist that Party in connection with the arbitration proceedings; (c) \"arbitration tribunal\" means a tribunal established under Article 740 of this Agreement; (d) \"arbitrator\" means a member of the arbitration tribunal; (e) \"assistant\" means an individual who, under the terms of appointment and under the direction and control of an arbitrator, conducts research or provides assistance to that arbitrator; (f) \"complaining Party\" means any Party that requests the establishment of an arbitration tribunal under Article 739 of this Agreement; (g) \"registry\" means an external body with relevant expertise appointed by the Parties to provide administrative support for the proceedings; (h) \"respondent Party\" means the Party that is alleged to be in violation of the covered provisions; and (i) \"representative of a Party\" means an employee or any individual appointed by a government department, agency or any other public entity of a Party who represents the Party for the purposes of a dispute under this Agreement or any supplementing agreement. II. Notifications 2. Any request, notice, written submission or other document of: (a) the arbitration tribunal shall be sent to both Parties at the same time; (b) a Party, which is addressed to the arbitration tribunal, shall be copied to the other Party at the same time; and (c) a Party, which is addressed to the other Party, shall be copied to the arbitration tribunal at the same time, as appropriate. 3. Any notification referred to in rule 2 shall be made by e-mail or, where appropriate, any other means of telecommunication that provides a record of the sending thereof. Unless proven otherwise, such notification shall be deemed to be delivered on the date of its sending. 4. All notifications shall be addressed to the Legal Service of the European Commission and to the Legal Adviser of the Foreign, Commonwealth & Development Office of the United Kingdom, respectively. 5. Minor errors of a clerical nature in a request, notice, written submission or other document related to the arbitration tribunal proceedings may be corrected by delivery of a new document clearly indicating the changes. 6. If the last day for delivery of a document falls on a non-working day of the institutions of the Union or of the government of the United Kingdom, the time period for the delivery of the document shall end on the first following working day. III. Appointment of arbitrators 7. If pursuant to Article 740 of this Agreement, an arbitrator is selected by lot, the co-chair of the Partnership Council of the complaining Party shall promptly inform the co-chair of the respondent Party of the date, time and venue of the lot. The respondent Party may, if it so chooses, be present during the lot. In any event, the lot shall be carried out with the Party or Parties that are present. 8. The co-chair of the complaining Party shall notify, in writing, each individual who has been selected to serve as an arbitrator of his or her appointment. Each individual shall confirm his or her availability to both Parties within five days from the date on which he or she was informed of his or her appointment. 9. The co-chair of the Partnership Council of the complaining Party shall select by lot the arbitrator or chairperson, within five days from the expiry of the time period referred to in Article 740(2) of this Agreement, if any of the sub-lists referred in Article 752(1) of this Agreement: (a) is not established, amongst those individuals who have been formally proposed by one or both Parties for the establishment of that particular sub-list; or (b) no longer contains at least five individuals, amongst those individuals who remain on that particular sub-list. 10. The Parties may appoint a registry to assist in the organisation and conduct of specific dispute settlement proceedings on the basis of ad-hoc arrangements or on the basis of arrangements adopted by the Partnership Council pursuant to Article 759 of this Agreement. To that end, the Partnership Council shall consider no later than 180 days after the entry into force of this Agreement whether there are any necessary amendments to these Rules of Procedure. IV. Organisational Meeting 11. Unless the Parties agree otherwise, they shall meet the arbitration tribunal within seven days of its establishment in order to determine such matters that the Parties or the arbitration tribunal deem to be appropriate, including: (a) if not determined earlier, the remuneration and expenses to be paid to the arbitrators, which shall in any case be in accordance with WTO standards; (b) the remuneration to be paid to assistants; the total amount of the remuneration of an assistant or assistants of each arbitrator shall not exceed 50 % of the remuneration of that arbitrator; (c) the timetable of the proceedings; and (d) ad-hoc procedures to protect confidential information. Arbitrators and representatives of the Parties may take part in this meeting via telephone or video conference. V. Written Submissions 12. The complaining Party shall deliver its written submission no later than 20 days after the date of establishment of the arbitration tribunal. The respondent Party shall deliver its written submission no later than 20 days after the date of delivery of the written submission of the complaining Party. VI. Operation of the arbitration tribunal 13. The chairperson of the arbitration tribunal shall preside at all its meetings. The arbitration tribunal may delegate to the chairperson the authority to make administrative and procedural decisions. 14. Unless otherwise provided in Title I of Part Six of this Agreement or in these Rules of Procedure, the arbitration tribunal may conduct its activities by any means, including telephone, facsimile transmissions or computer links. 15. Only arbitrators may take part in the deliberations of the arbitration tribunal, but the arbitration tribunal may permit their assistants to be present at its deliberations. 16. The drafting of any ruling, decision and report shall remain the exclusive responsibility of the arbitration tribunal and shall not be delegated. 17. Where a procedural question arises that is not covered by Title I of Part Six of this Agreement and its Annexes, the arbitration tribunal, after consulting the Parties, may adopt an appropriate procedure that is compatible with those provisions. 18. When the arbitration tribunal considers that there is a need to modify any of the time periods for the proceedings other than the time periods set out in Title I of Part Six of this Agreement or to make any other procedural or administrative adjustment, it shall inform the Parties, in writing and after consultation of the Parties, of the reasons for the change or adjustment and of the time period or adjustment needed. VII. Replacement 19. When a Party considers that an arbitrator does not comply with the requirements of Annex 49 and for that reason should be replaced, that Party shall notify the other Party within 15 days from when it obtained sufficient evidence of the arbitrator's alleged failure to comply with the requirements of that Annex. 20. The Parties shall consult within 15 days of the notification referred to in rule 19. They shall inform the arbitrator of his or her alleged failure and they may request the arbitrator to take steps to ameliorate the failure. They may also, if they so agree, remove the arbitrator and select a new arbitrator in accordance with Article 740 of this Agreement. 21. If the Parties fail to agree on the need to replace the arbitrator, other than the chairperson of the arbitration tribunal, either Party may request that this matter be referred to the chairperson of the arbitration tribunal, whose decision shall be final. If the chairperson of the arbitration tribunal finds that the arbitrator does not comply with the requirements of Annex 49, the new arbitrator shall be selected in accordance with Article 740 of this Agreement. 22. If the Parties fail to agree on the need to replace the chairperson, either Party may request that this matter be referred to one of the remaining members of the pool of individuals from the sub-list of chairpersons established under Article 752 of this Agreement. His or her name shall be drawn by lot by the co-chair of the Partnership Council from the requesting Party, or the chair's delegate. The decision by the selected person on the need to replace the chairperson shall be final. If this person finds that the chairperson does not comply with the requirements of Annex 49, the new chairperson shall be selected in accordance with Article 740 of this Agreement. VIII. Hearings 23. On the basis of the timetable determined pursuant to rule 11, after consulting with the Parties and the other arbitrators, the chairperson of the arbitration tribunal shall notify the Parties of the date, time and venue of the hearing. That information shall be made publicly available by the Party in which the hearing takes place, unless the hearing is closed to the public. 24. Unless the Parties agree otherwise, the hearing shall be held in London if the complaining Party is the Union and in Brussels if the complaining Party is the United Kingdom. The respondent Party shall bear the expenses derived from the logistical administration of the hearing. 25. The arbitration tribunal may convene additional hearings if the Parties so agree. 26. All arbitrators shall be present during the entirety of the hearing. 27. Unless the Parties agree otherwise, the following persons may attend the hearing, irrespective of whether the hearing is open to the public or not: (a) representatives of a Party; (b) advisers; (c) assistants and administrative staff; (d) interpreters, translators and court reporters of the arbitration tribunal; and (e) experts, as decided by the arbitration tribunal pursuant to Article 751(2) of this Agreement. 28. No later than five days before the date of a hearing, each Party shall deliver to the arbitration tribunal and to the other Party a list of the names of persons who will make oral arguments or presentations at the hearing on behalf of that Party and of other representatives and advisers who will be attending the hearing. 29. The arbitration tribunal shall conduct the hearing in the following manner, ensuring that the complaining Party and the respondent Party are afforded equal time in both argument and rebuttal argument: Argument (a) argument of the complaining Party; (b) argument of the respondent Party. Rebuttal Argument (a) reply of the complaining Party; (b) counter-reply of the respondent Party. 30. The arbitration tribunal may direct questions to either Party at any time during the hearing. 31. The arbitration tribunal shall arrange for a transcript of the hearing to be prepared and delivered to the Parties as soon as possible after the hearing. The Parties may comment on the transcript and the arbitration tribunal may consider those comments. 32. Each Party may deliver a supplementary written submission concerning any matter that arises during the hearing within 10 days after the date of the hearing. IX. Questions in Writing 33. The arbitration tribunal may at any time during the proceedings submit questions in writing to one or both Parties. Any questions submitted to one Party shall be copied to the other Party. 34. Each Party shall provide the other Party with a copy of its responses to the questions submitted by the arbitration tribunal. The other Party shall have an opportunity to provide comments in writing on the Party's responses within five days after the delivery of such copy. X. Confidentiality 35. Each Party and the arbitration tribunal shall treat as confidential any information submitted by the other Party to the arbitration tribunal that the other Party has designated as confidential. When a Party submits to the arbitration tribunal a written submission which contains confidential information, it shall also provide, within 15 days, a submission without the confidential information which shall be disclosed to the public. 36. Nothing in these Rules of Procedure shall preclude a Party from disclosing statements of its own positions to the public to the extent that, when making reference to information submitted by the other Party, it does not disclose any information designated by the other Party as confidential. 37. The arbitration tribunal shall hold the relevant parts of the session in private when the submission and arguments of a Party contains confidential information. The Parties shall maintain the confidentiality of the arbitration tribunal hearings when the hearings are held in closed session. XI. Ex parte contacts 38. The arbitration tribunal shall not meet or communicate with a Party in the absence of the other Party. 39. An arbitrator shall not discuss any aspect of the subject matter of the proceedings with a Party or both Parties in the absence of the other arbitrators. XII. Amicus curiae submissions 40. Unless the Parties agree otherwise within five days of the date of the establishment of the arbitration tribunal, the arbitration tribunal may receive unsolicited written submissions from natural persons of a Party or legal persons established in the territory of a Party that are independent from the governments of the Parties, provided that they: (a) are received by the arbitration tribunal within 10 days of the date of the establishment of the arbitration tribunal; (b) are concise and in no case longer than 15 pages, including any annexes, typed at double space; (c) are directly relevant to a factual or a legal issue under consideration by the arbitration tribunal; (d) contain a description of the person making the submission, including for a natural person his or her nationality and for a legal person its place of establishment, the nature of its activities, its legal status, general objectives and its source of financing; (e) specify the nature of the interest that the person has in the arbitration proceedings; and (f) are drafted in English. 41. The submissions shall be delivered to the Parties for their comments. The Parties may submit comments, within 10 days of the delivery, to the arbitration tribunal. 42. The arbitration tribunal shall list in its report all the submissions it has received pursuant to rule 40. The arbitration tribunal shall not be obliged to address in its report the arguments made in such submissions, however, if it does, it shall also take into account any comments made by the Parties pursuant to rule 41. XIII. Urgent cases 43. In cases of urgency referred to in Article 744 of this Agreement, the arbitration tribunal, after consulting the Parties, shall adjust, as appropriate, the time periods referred to in these Rules of Procedure. The arbitration tribunal shall notify the Parties of such adjustments. XIV. Translation and interpretation 44. The language of proceedings before the arbitration tribunal shall be English. Rulings, reports and decisions of the arbitration tribunal shall be issued in English. 45. Each party shall bear its own costs of the translation of any documents submitted to the arbitration tribunal which are not originally drafted in English, as well as any costs relating to interpretation during the hearing related to its representatives or advisers. XV. Other Procedures 46. The time periods laid down in these Rules of Procedure shall be adjusted in accordance with the special time periods provided for the adoption of a report or decision by the arbitration tribunal in the proceedings provided for in Articles 747 to 750 of this Agreement. ANNEX 49 CODE OF CONDUCT FOR ARBITRATORS I. Definitions 1. For the purposes of this Code of Conduct, the following definitions apply: (a) \"administrative staff\" means, in respect of an arbitrator, individuals under the direction and control of an arbitrator, other than assistants; (b) \"arbitrator\" means a member of an arbitration tribunal; (c) \"assistant\" means an individual who, under the terms of appointment of an arbitrator, conducts research or provides assistance to that arbitrator; and (d) \"candidate\" means an individual whose name is on a list of arbitrators referred to in Article 752 of this Agreement or who is under consideration for selection as an arbitrator under Article 740 of this Agreement. II. Governing Principles 2. In order to preserve the integrity and impartiality of the dispute settlement mechanism, each candidate and arbitrator shall: (a) get acquainted with this Code of Conduct; (b) be independent and impartial; (c) avoid direct or indirect conflicts of interest; (d) avoid impropriety and the appearance of impropriety or bias; (e) observe high standards of conduct; and (f) not be influenced by self-interest, outside pressure, political considerations, public clamour, and loyalty to a Party or fear of criticism. 3. An arbitrator shall not, directly or indirectly, incur any obligation or accept any benefit that would in any way interfere, or appear to interfere, with the proper performance of his or her duties. 4. An arbitrator shall not use his or her position on the arbitration tribunal to advance any personal or private interests. An arbitrator shall avoid actions that may create the impression that others are in a special position to influence him or her. 5. An arbitrator shall not allow past or existing financial, business, professional, personal, or social relationships or responsibilities to influence his or her conduct or judgement. 6. An arbitrator shall avoid entering into any relationship or acquiring any financial interest that is likely to affect his or her impartiality or that might reasonably create an appearance of impropriety or bias. III. Disclosure obligations 7. Prior to the acceptance of his or her appointment as an arbitrator under Article 740 of this Agreement, a candidate requested to serve as an arbitrator shall disclose any interest, relationship or matter that is likely to affect his or her independence or impartiality or that might reasonably create an appearance of impropriety or bias in the proceedings. To that end, a candidate shall make all reasonable efforts to become aware of any such interests, relationships and matters, including financial interests, professional interests, or employment or family interests. 8. The disclosure obligation under paragraph 7 is a continuing duty which requires an arbitrator to disclose any such interests, relationships or matters that may arise during any stage of the proceedings. 9. A candidate or an arbitrator shall communicate to the Partnership Council for consideration by the Parties any matters concerning actual or potential violations of this Code of Conduct at the earliest time he or she becomes aware of them. IV. Duties of Arbitrators 10. Upon acceptance of his or her appointment, an arbitrator shall be available to perform and shall perform his or her duties thoroughly and expeditiously throughout the proceedings, and with fairness and diligence. 11. An arbitrator shall consider only the issues raised in the proceedings and which are necessary for a decision and shall not delegate that duty to any other person. 12. An arbitrator shall take all appropriate steps to ensure that his or her assistants and administrative staff are aware of, and comply with, the obligations incurred by arbitrators under Parts II, III, IV and VI of this Code of Conduct. V. Obligations of Former Arbitrators 13. Each former arbitrator shall avoid actions that may create the appearance that he or she was biased in carrying out the duties or derived advantage from the decision of the arbitration tribunal. 14. Each former arbitrator shall comply with the obligations in Part VI of this Code of Conduct. VI. Confidentiality 15. An arbitrator shall not, at any time, disclose any non-public information concerning the proceedings or acquired during the proceedings for which he or she has been appointed. An arbitrator shall not, in any case, disclose or use such information to gain personal advantage or advantage for others or to adversely affect the interests of others. 16. An arbitrator shall not disclose a decision of the arbitration tribunal or parts thereof prior to its publication in accordance with Title I of Part Six of this Agreement. 17. An arbitrator shall not, at any time, disclose the deliberations of an arbitration tribunal, or any arbitrator's view, nor make any statements on the proceedings for which he or she has been appointed or on the issues in dispute in the proceedings. VII. Expenses 18. Each arbitrator shall keep a record and render a final account of the time devoted to the proceedings and of his or her expenses, as well as the time and expenses of his or her assistants and administrative staff. PROTOCOL ON ADMINISTRATIVE COOPERATION AND COMBATING FRAUD IN THE FIELD OF VALUE ADDED TAX AND ON MUTUAL ASSISTANCE FOR THE RECOVERY OF CLAIMS RELATING TO TAXES AND DUTIES TITLE I GENERAL PROVISIONS Article PVAT.1 Objective The objective of this Protocol is to establish the framework for administrative cooperation between the Member States and the United Kingdom, in order to enable their authorities to assist each other in ensuring compliance with VAT legislation and in protecting VAT revenue and in recovering claims relating to taxes and duties. Article PVAT.2 Scope 1. This Protocol lays down rules and procedures for cooperation: (a) to exchange any information that may help to effect a correct assessment of VAT, monitor the correct application of VAT, and combat VAT fraud; and (b) for the recovery of: (i) claims relating to VAT, customs duties and excise duties, levied by or on behalf of a State or its territorial or administrative subdivisions, excluding the local authorities, or on behalf of the Union; (ii) administrative penalties, fines, fees and surcharges relating to the claims referred to in point (i) imposed by the administrative authorities that are competent to levy the taxes or duties concerned or carry out administrative enquiries with regard to them, or confirmed by administrative or judicial bodies at the request of those administrative authorities; and (iii) interest and costs relating to the claims referred to in points (i) and (ii). 2. This Protocol does not affect the application of the rules on administrative cooperation and combating fraud in the field of VAT and assistance for the recovery of claims between Member States. 3. This Protocol does not affect the application of the rules on mutual assistance in criminal matters. Article PVAT.3 Definitions For the purpose of this Protocol, the following definitions apply: (a) \"administrative enquiry\" means all the controls, checks and other action taken by the States in the performance of their duties with a view to ensuring the proper application of the VAT legislation; (b) \"applicant authority\" means a central liaison office or a liaison department of a State which makes a request under Title III; (c) \"automatic exchange\" means the systematic communication of predefined information to another State, without prior request; (d) \"by electronic means\" means using electronic equipment for the processing (including digital compression) and storage of data, and employing wires, radio transmission, optical technologies or other electromagnetic means; (e) \"CCN/CSI network\" means the common platform based on the common communication network (\"CCN\") and common system interface (\"CSI\"), developed by the Union to ensure all transmissions by electronic means between competent authorities in the area of taxation; (f) \"central liaison office\" means the office designated pursuant to Article PVAT.4(2) with the principal responsibility for contacts for the application of Title II or Title III; (g) \"competent authority\" means the authority designated pursuant to Article PVAT.4(1); (h) \"competent official\" means any official designated pursuant to Article PVAT.4(4) who can directly exchange information under Title II; (i) \"customs duties\" means the duty payable on goods entering or leaving the customs territory of each Party in accordance with the rules set out in the customs legislation of the respective Parties; (j) \"excise duties\" means those duties and charges defined as such under the domestic legislation of the State in which the applicant authority is located; (k) \"liaison department\" means any office other than the central liaison office designated as such pursuant to Article PVAT.4(3) to request or grant mutual assistance under Title II or Title III; (l) \"person\" means any person as defined in point (l) of Article 512 of this Agreement; (1) (m) \"requested authority\" means the central liaison office, the liaison department or, as far as cooperation under Title II is concerned, the competent official who receives a request from a requesting or an applicant authority; (n) \"requesting authority\" means a central liaison office, a liaison department or a competent official who makes a request for assistance under Title II, on behalf of a competent authority; (o) \"simultaneous control\" means the coordinated checking of the tax situation of a taxable person or of two or more related taxable persons organised by two or more States with common or complementary interests; (p) \"Specialised Committee\" means the Trade Specialised Committee on Administrative Cooperation in VAT and Recovery of Taxes and Duties; (q) \"spontaneous exchange\" means the non-systematic communication, at any moment and without prior request, of information to another State; (r) \"State\" means a Member State or the United Kingdom, as the context requires; (s) \"third country\" means a country that is neither a Member State nor the United Kingdom; (t) \"VAT\" means value added tax pursuant to Council Directive 2006/112/EC on the common system of value added tax for the Union and means value added tax pursuant to the Value Added Tax Act 1994 for the United Kingdom. Article PVAT.4 Organisation 1. Each State shall designate a competent authority responsible for the application of this Protocol. 2. Each State shall designate: (a) one central liaison office with the principal responsibility for the application of Title II of this Protocol; and (b) one central liaison office with the principal responsibility for the application of Title III of this Protocol. 3. Each competent authority may designate, directly or by delegation: (a) liaison departments to exchange directly information under Title II of this Protocol; (b) liaison departments to request or grant mutual assistance under Title III of this Protocol, in relation to their specific territorial or operational competences. 4. Each competent authority may designate, directly or by delegation, competent officials who can directly exchange information on the basis of Title II of this Protocol 5. Each central liaison office shall keep the list of liaison departments and competent officials up-to-date and make it available to the other central liaison offices. 6. Where a liaison department or a competent official sends or receives a request for assistance under this Protocol, it shall inform its central liaison office thereof. 7. Where a central liaison office, a liaison department or a competent official receives a request for mutual assistance requiring action outside its competence, it shall forward the request without delay to the competent central liaison office or liaison department, and shall inform the requesting or applicant authority thereof. In such a case, the period laid down in Article PVAT.8 shall start the day after the request for assistance has been forwarded to the competent central liaison office or the competent liaison department. 8. Each Party shall inform the Specialised Committee of its competent authorities for the purposes of this Protocol within one month of the signature of this Agreement and of any changes regarding those competent authorities without delay. The Specialised Committee shall keep the list of competent authorities updated. Article PVAT.5 Service level agreement A service level agreement ensuring the technical quality and quantity of the services for the functioning of the communication and information exchange systems shall be concluded according to a procedure established by the Specialised Committee. Article PVAT.6 Confidentiality 1. Any information obtained by a State under this Protocol shall be treated as confidential and shall be protected in the same manner as information obtained under its domestic law. 2. Such information may be disclosed to persons or authorities (including courts and administrative or supervisory bodies) concerned with the application of VAT laws and for the purpose of a correct assessment of VAT as well as for the purpose of applying enforcement measures including recovery or precautionary measures with regard to claims referred to in point (b) of Article PVAT.2(1). 3. The information referred to in paragraph 1 may also be used for assessment of other taxes and for assessment and enforcement, including recovery or precautionary measures, with regard to claims relating to compulsory social security contributions. If the information exchanged reveals or helps to prove the existence of breaches of the tax law, it may also be used for imposing administrative or criminal sanctions. Only the persons or authorities mentioned in paragraph 2 may use the information and then only for purposes set out in the preceding sentences of this paragraph. They may disclose it in public court proceedings or in judicial decisions. 4. Notwithstanding paragraphs 1 and 2, the State providing the information shall, on the basis of a reasoned request, permit its use for purposes other than those referred to in Article PVAT.2(1) by the State which receives the information if, under the legislation of the State providing the information, the information may be used for similar purposes. The requested authority shall accept or refuse any such request within one month. 5. Reports, statements and any other documents, or certified true copies or extracts thereof, obtained by a State under the assistance provided by this Protocol may be invoked as evidence in that State on the same basis as similar documents provided by another authority of that State. 6. Information provided by a State to another State may be transmitted by the latter to another State, subject to prior authorisation by the competent authority from which the information originated. The State of origin of the information may oppose such a sharing of information within ten working days of the date on which it received the communication from the State wishing to share the information. 7. The States may transmit information obtained in accordance with this Protocol to third countries subject to the following conditions: (a) the competent authority from which the information originates has consented to that transmission; and (b) the transmission is permitted by assistance arrangements between the State transmitting the information and that particular third country. 8. When a State receives information from a third country, the States may exchange that information, in so far as permitted by the assistance arrangements with that particular third country. 9. Each State shall immediately notify the other States concerned regarding any breach of confidentiality, and any sanctions and remedial actions consequently imposed. 10. Persons duly accredited by the Security Accreditation Authority of the European Commission may have access to this information only in so far as it is necessary for care, maintenance and development of the electronic systems hosted by the Commission and used by the States to implement this Protocol. TITLE II ADMINISTRATIVE COOPERATION AND COMBATING VAT FRAUD CHAPTER ONE EXCHANGE OF INFORMATION ON REQUEST Article PVAT.7 Exchange of information and administrative enquiries 1. At the request of the requesting authority, the requested authority shall communicate the information referred to in point (a) of Article PVAT.2(1), including any information relating to a specific case or cases. 2. For the purpose of forwarding the information referred to in paragraph 1, the requested authority shall arrange for the conduct of any administrative enquiries necessary to obtain such information. 3. The request referred to in paragraph 1 may contain a reasoned request for a specific administrative enquiry. The requested authority shall undertake the administrative enquiry in consultation with the requesting authority where necessary. If the requested authority takes the view that no administrative enquiry is necessary, it shall immediately inform the requesting authority of the reasons thereof. 4. Where the requested authority refuses to undertake an administrative enquiry into amounts that were declared or amounts that should have been declared by a taxable person established in the State of the requested authority in connection with supplies of goods or services and imports of goods which are made by that taxable person and which are taxable in the State of the requesting authority, the requested authority shall at least provide to the requesting authority the dates and values of any relevant supplies and imports made by the taxable person in the State of the requesting authority over the previous two years, unless the requested authority does not hold and is not required to hold this information under domestic legislation. 5. In order to obtain the information sought or to conduct the administrative enquiry requested, the requested authority or the administrative authority to which it has recourse shall proceed as though acting on its own account or at the request of another authority in its own State. 6. At the request of the requesting authority, the requested authority shall communicate to it any pertinent information it obtains or has in its possession as well as the results of administrative enquiries, in the form of reports, statements and any other documents, or certified true copies or extracts thereof. 7. Original documents shall be provided only where this is not contrary to the provisions in force in the State of the requested authority. Article PVAT.8 Time limit for providing information 1. The requested authority shall provide the information referred to in Article PVAT.7 as quickly as possible and no later than 90 days following the date of receipt of the request. However, where the requested authority is already in possession of that information, the time limit shall be reduced to a maximum period of 30 days. 2. In certain special categories of cases, time limits which are different from those provided for in paragraph 1 may be agreed between the requested and the requesting authorities. 3. Where the requested authority is unable to respond to the request within the time limits referred to in paragraphs 1 and 2, it shall forthwith inform the requesting authority in writing of the reasons for its failure to do so, and when it considers it would be likely to be able to respond. CHAPTER TWO EXCHANGE OF INFORMATION WITHOUT PRIOR REQUEST Article PVAT.9 Types of exchange of information The exchange of information without prior request shall either be spontaneous exchanges, as provided for in Article PVAT.10, or automatic exchanges, as provided for in Article PVAT.11. Article PVAT.10 Spontaneous exchange of information The competent authority of a State shall, without prior request, forward to the competent authority of another State the information referred to in point (a) of Article PVAT.2(1) which has not been forwarded under the automatic exchange referred to in Article PVAT.11 and of which it is aware of in the following cases: (a) where taxation is deemed to take place in another State and information is necessary for the effectiveness of the control system of that State; (b) where a State has grounds to believe that a breach of VAT legislation has been committed or is likely to have been committed in the other State; (c) where there is a risk of tax loss in the other State. Article PVAT.11 Automatic exchange of information 1. The categories of information subject to automatic exchange shall be determined by the Specialised Committee in accordance with Article PVAT.39. 2. A State may abstain from taking part in the automatic exchange of one or more categories of information referred to in paragraph 1 where the collection of information for such exchange would require the imposition of new obligations on persons liable for VAT or would impose a disproportionate administrative burden on that State. 3. Each State shall notify the Specialised Committee in writing of its decision taken in accordance with the previous paragraph. CHAPTER THREE OTHER FORMS OF COOPERATION Article PVAT.12 Administrative notification 1. The requested authority shall, at the request of the requesting authority and in accordance with the rules governing the notification of similar instruments and decisions in the State of the requested authority, notify the addressee of all instruments and decisions which have been sent from the requesting authorities and concern the application of VAT legislation in the State of the requesting authority. 2. Requests for notification, mentioning the subject of the instrument or decision to be notified, shall indicate the name, address and any other relevant information for identifying the addressee. 3. The requested authority shall inform the requesting authority immediately of its response to the request for notification and notify it, in particular, of the date of notification of the decision or instrument to the addressee. Article PVAT.13 Presence in administrative offices and participation in administrative enquiries 1. By agreement between the requesting authority and the requested authority, and in accordance with the arrangements laid down by the latter, the requested authority may allow officials authorised by the requesting authority to be present in the offices of the requested authority, or any other place where those authorities carry out their duties, with a view to exchanging the information referred to in point (a) of Article PVAT.2(1). Where the requested information is contained in documentation to which the officials of the requested authority have access, the officials of the requesting authority shall be given copies thereof on request. 2. By agreement between the requesting authority and the requested authority, and in accordance with the arrangements laid down by the latter, the requested authority may allow officials authorised by the requesting authority to be present during the administrative enquiries carried out in the territory of the State of the requested authority, with a view to exchanging the information referred to in point (a) of Article PVAT.2(1). Such administrative enquiries shall be carried out exclusively by the officials of the requested authority. The officials of the requesting authority shall not exercise the powers of inspection conferred on officials of the requested authority. They may, however, have access to the same premises and documents as the latter, through the intermediation of the officials of the requested authority and for the sole purpose of carrying out the administrative enquiry. 3. By agreement between the requesting authorities and the requested authority, and in accordance with the arrangements laid down by the latter, officials authorised by the requesting authorities may take part in the administrative enquiries carried out in the territory of the requested State with a view to collecting and exchanging the information referred to in point (a) of Article PVAT.2(1). Such administrative enquiries shall be carried out jointly by the officials of the requesting and requested authorities and shall be conducted under the direction and according to the legislation of the requested State. The officials of the requesting authorities shall have access to the same premises and documents as the officials of the requested authority and, in so far as it is permitted under the legislation of the requested State for its officials, shall be able to interview taxable persons. Where it is permitted under the legislation of the requested State, the officials of the requesting States shall exercise the same inspection powers as those conferred on officials of the requested State. The inspection powers of the officials of the requesting authorities shall be exercised for the sole purpose of carrying out the administrative enquiry. By agreement between the requesting authorities and the requested authority and in accordance with the arrangements laid down by the requested authority, the participating authorities may draft a common enquiry report. 4. The officials of the requesting authority present in another State in accordance with paragraphs 1, 2 and 3 must at all times be able to produce written authority stating their identity and their official capacity. Article PVAT.14 Simultaneous controls 1. The States may agree to conduct simultaneous controls whenever they consider such controls to be more effective than controls carried out by only one State. 2. A State shall identify independently the taxable persons which it intends to propose for a simultaneous control. The competent authority of that State shall notify the competent authority of the other State concerned of the cases proposed for a simultaneous control. It shall give reasons for its choice, as far as possible, by providing the information which led to its decision. It shall specify the period of time during which such controls should be conducted. 3. A competent authority that receives the proposal for a simultaneous control shall confirm its agreement or communicate its reasoned refusal to the counterpart authority, in principle within two weeks of receipt of the proposal, but within a month of receipt of the proposal at the latest. 4. Each competent authority concerned shall appoint a representative to be responsible for supervising and coordinating the control operation. CHAPTER FOUR GENERAL PROVISIONS Article PVAT.15 Conditions governing the exchange of information 1. The requested authority shall provide a requesting authority with the information referred to in point (a) of Article PVAT.2(1) or carry out an administrative notification referred to in Article PVAT.12, provided that: (a) the number and nature of the requests for information or administrative notification made by the requesting authority do not impose a disproportionate administrative burden on that requested authority; and (b) the requesting authority has exhausted the usual sources of information which it could have used in the circumstances to obtain the information requested or measures which it could reasonably have taken to carry out the administrative notification requested, without running the risk of jeopardising the achievement of the desired end. 2. This Protocol shall impose no obligation to have enquiries carried out or to provide information on a particular case if the laws or administrative practices of the State which would have to supply the information do not authorise that State to carry out those enquiries or collect or use that information for its own purposes. 3. A requested authority may refuse to provide information where the requesting authority is unable, for legal reasons, to provide similar information. The requested authority shall inform the Specialised Committee of the grounds for the refusal. 4. The provision of information may be refused where it would lead to the disclosure of a commercial, industrial or professional secret or of a commercial process, or of information whose disclosure would be contrary to public policy. 5. Paragraphs 2, 3 and 4 should in no case be interpreted as authorising the requested authority to refuse to supply information on the sole grounds that this information is held by a bank, other financial institution, nominee or person acting in an agency or fiduciary capacity or because it relates to ownership interests in a legal person. 6. The requested authority shall inform the requesting authority of the grounds for refusing a request for assistance. Article PVAT.16 Feedback Where a competent authority provides information pursuant to Article PVAT.7 or PVAT.10, it may request the competent authority which receives the information to give feedback thereon. If such request is made, the competent authority which receives the information shall, without prejudice to the rules on tax secrecy and data protection applicable in its State, send feedback as soon as possible, provided that this does not impose a disproportionate administrative burden on it. Article PVAT.17 Language Requests for assistance, including requests for notification and attached documents, shall be made in a language agreed between the requested and requesting authority. Article PVAT.18 Statistical data 1. By 30 June each year, the Parties shall communicate by electronic means to the Specialised Committee statistical data on the application of this Title. 2. The content and format of the statistical data to be communicated under paragraph 1 shall be determined by the Specialised Committee. Article PVAT.19 Standard forms and means of communication 1. Any information communicated pursuant to Articles PVAT.7, PVAT.10, PVAT.11, PVAT.12 and PVAT.16 and the statistics communicated pursuant to Article PVAT.18 shall be provided using a standard form referred to in point (d) of Article PVAT.39(2), except in the cases referred to in Article PVAT.6(7) and (8) or in specific cases where the respective competent authorities deem other secure means more appropriate and agree to use those means. 2. The standard forms shall be transmitted, in so far as possible, by electronic means. 3. Where the request has not been lodged completely through the electronic systems, the requested authority shall confirm receipt of the request by electronic means without delay and, in any event, no later than five working days after receipt. 4. Where an authority has received a request or information of which it is not the intended recipient, it shall send a message by electronic means to the sender without delay and, in any event, no later than five working days after receipt. 5. Pending the adoption by the Specialised Committee of the decisions referred to in Article PVAT.39(2), the competent authorities shall make use of the rules set out in the Annex to this Protocol, including the standard forms. TITLE III RECOVERY ASSISTANCE CHAPTER ONE EXCHANGE OF INFORMATION Article PVAT.20 Request for information 1. At the request of the applicant authority, the requested authority shall provide any information which is foreseeably relevant to the applicant authority in the recovery of its claims as referred to in point (b) of Article PVAT.2(1). The request for information shall include, where available, the name and any other data relevant to the identification of the persons concerned. For the purpose of providing that information, the requested authority shall arrange for the carrying-out of any administrative enquiries necessary to obtain it. 2. The requested authority shall not be obliged to supply information: (a) which it would not be able to obtain for the purpose of recovering similar claims on its own behalf; (b) which would disclose any commercial, industrial or professional secrets; or (c) the disclosure of which would be liable to prejudice the security of or be contrary to the public policy of the State of the requested authority. 3. Paragraph 2 shall in no case be construed as permitting a requested authority to decline to supply information solely because this information is held by a bank, other financial institution, nominee or person acting in an agency or a fiduciary capacity or because it relates to ownership interests in a legal person. 4. The requested authority shall inform the applicant authority of the grounds for refusing a request for information. Article PVAT.21 Exchange of information without prior request Where a refund of taxes or duties relates to a person established or resident in another State, the State from which the refund is to be made may inform the State of establishment or residence of the pending refund. Article PVAT.22 Presence in administrative offices and participation in administrative enquiries 1. By agreement between the applicant authority and the requested authority, and in accordance with the arrangements laid down by the latter, officials authorised by the applicant authority may, with a view to promoting mutual assistance provided for in this Title: (a) be present in the offices where officials of the requested State carry out their duties; (b) be present during administrative enquiries carried out in the territory of the requested State; and (c) assist the competent officials of the requested State during court proceedings in that State. 2. In so far as it is permitted under applicable legislation in the requested State, the agreement referred to in point (b) of paragraph 1 may provide that officials of the applicant authority may interview individuals and examine records. 3. Officials authorised by the applicant authority who make use of the possibility offered by paragraphs 1 and 2 must at all times be able to produce written authority stating their identity and their official capacity. CHAPTER TWO ASSISTANCE FOR THE NOTIFICATION OF DOCUMENTS Article PVAT.23 Request for notification of certain documents relating to claims 1. At the request of the applicant authority, the requested authority shall notify to the addressee all documents, including those of a judicial nature, which have been sent from the State of the applicant authority and which relate to a claim as referred to in point (b) of Article PVAT.2(1) or to its recovery. The request for notification shall be accompanied by a standard form containing at least the following information: (a) name, address and other data relevant to the identification of the addressee; (b) the purpose of the notification and the period within which notification should be effected; (c) a description of the attached document and the nature and amount of the claim concerned; and (d) name, address and other contact details regarding: (i) the office responsible with regard to the attached document; and (ii) if different, the office where further information can be obtained concerning the notified document or concerning the possibilities for contesting the payment obligation. 2. The applicant authority shall make a request for notification pursuant to this Article only when it is unable to notify in accordance with the rules governing the notification of the document concerned in its own State or when such notification would give rise to disproportionate difficulties. 3. The requested authority shall forthwith inform the applicant authority of any action taken on its request for notification and in particular of the date of notification of the document to the addressee. Article PVAT.24 Means of notification 1. The requested authority shall ensure that notification in the requested State is effected in accordance with the applicable national laws, regulations and administrative practices. 2. Paragraph 1 is without prejudice to any other form of notification made by a competent authority of the applicant State in accordance with the rules in force in that State. A competent authority established in the applicant State may notify any document directly by registered mail or electronically to a person within the territory of another State. CHAPTER THREE RECOVERY OR PRECAUTIONARY MEASURES Article PVAT.25 Request for recovery 1. At the request of the applicant authority, the requested authority shall recover claims which are the subject of an instrument permitting enforcement in the State of the applicant authority. 2. As soon as any relevant information relating to the matter which gave rise to the request for recovery comes to the knowledge of the applicant authority, it shall forward it to the requested authority. Article PVAT.26 Conditions governing a request for recovery 1. The applicant authority may not make a request for recovery if and as long as the claim or the instrument permitting its enforcement are contested in the State of the applicant authority, except in cases where the third subparagraph of Article PVAT.29(4) applies. 2. Before the applicant authority makes a request for recovery, appropriate recovery procedures available in the State of the applicant authority shall be applied, except in the following situations: (a) where it is obvious that there are no assets for recovery in that State or that such procedures will not result in the payment of a substantial amount, and the applicant authority has specific information indicating that the person concerned has assets in the State of the requested authority; (b) where recourse to such procedures in the State of the applicant authority would give rise to disproportionate difficulty. Article PVAT.27 Instrument permitting enforcement in the State of the requested authority and other accompanying documents 1. Any request for recovery shall be accompanied by a uniform instrument permitting enforcement in the State of the requested authority. This uniform instrument permitting enforcement shall reflect the substantial contents of the initial instrument permitting enforcement in the State of the applicant authority, and constitute the sole basis for recovery and precautionary measures in the State of the requested authority. No act of recognition, supplementing or replacement shall be required in that State. The uniform instrument permitting enforcement shall contain at least the following information: (a) information relevant to the identification of the initial instrument permitting enforcement, a description of the claim, including its nature, the period covered by the claim, any dates of relevance to the enforcement process, and the amount of the claim and its different components such as principal, interest accrued, etc.; (b) name and other data relevant to the identification of the debtor; and (c) name, address and other contact details regarding: (i) the office responsible for the assessment of the claim; and (ii) if different, the office where further information can be obtained concerning the claim or the possibilities for contesting the payment obligation. 2. The request for recovery of a claim may be accompanied by other documents relating to the claim issued by the State of the applicant authority. Article PVAT.28 Execution of the request for recovery 1. For the purpose of the recovery in the State of the requested authority, any claim in respect of which a request for recovery has been made shall be treated as if it was a claim of that State, except where otherwise provided for in this Protocol. The requested authority shall make use of the powers and procedures provided under the laws, regulations or administrative provisions of that State applying to its claims except where otherwise provided for in this Protocol. The State of the requested authority shall not be obliged to grant to claims whose recovery is requested preferences accorded to similar claims arising in the State of the requested authority, except where otherwise agreed or provided under the law of that State. The State of the requested authority shall recover the claim in its own currency. 2. The requested authority shall inform the applicant authority with due diligence of any action it has taken on the request for recovery. 3. From the date on which the recovery request is received, the requested authority shall charge interest for late payment in accordance with the laws, regulations and administrative provisions applicable to its own claims. 4. The requested authority may, where the applicable laws, regulations or administrative provisions so permit, allow the debtor time to pay or authorise payment by instalment and it may charge interest in that respect. It shall inform the applicant authority of any such decision. 5. Without prejudice to Article PVAT.35(1), the requested authority shall remit to the applicant authority the amounts recovered with respect to the claim and the interest referred to in paragraphs 3 and 4 of this Article. Article PVAT.29 Disputed claims and enforcement measures 1. Disputes concerning the claim, the initial instrument permitting enforcement in the State of the applicant authority or the uniform instrument permitting enforcement in the State of the requested authority and disputes concerning the validity of a notification made by an applicant authority shall fall within the competence of the competent bodies of the State of the applicant authority. If, in the course of the recovery procedure, the claim, the initial instrument permitting enforcement in the State of the applicant authority or the uniform instrument permitting enforcement in the State of the requested authority is contested by an interested party, the requested authority shall inform that party that such an action must be brought by the latter before the competent body of the State of the applicant authority in accordance with the laws in force there. 2. Disputes concerning enforcement measures taken in the State of the requested authority or concerning the validity of a notification made by an authority of the requested State shall be brought before the competent body of that State in accordance with its laws and regulations. 3. Where an action as referred to in paragraph 1 has been brought, the applicant authority shall inform the requested authority thereof and shall indicate the extent to which the claim is not contested. 4. As soon as the requested authority has received the information referred to in paragraph 3, either from the applicant authority or from the interested party, it shall suspend the enforcement procedure, as far as the contested part of the claim is concerned, pending the decision of the body competent in the matter, unless the applicant authority requests otherwise in accordance with the third subparagraph of this paragraph. At the request of the applicant authority, or where otherwise deemed to be necessary by the requested authority, and without prejudice to Article PVAT.31, the requested authority may take precautionary measures to guarantee recovery in so far as the applicable laws or regulations allow. The applicant authority may, in accordance with the laws, regulations and administrative practices in force in its State, ask the requested authority to recover a contested claim or the contested part of a claim, in so far as the laws, regulations and administrative practices in force in the State of the requested authority allow. Any such request shall be reasoned. If the result of contestation is subsequently favourable to the debtor, the applicant authority shall be liable for reimbursing any sums recovered, together with any compensation due, in accordance with the laws in force in the State of the requested authority. If a mutual agreement procedure has been initiated between the State of the applicant authority and the State of requested authority, and the outcome of the procedure may affect the claim in respect of which assistance has been requested, the recovery measures shall be suspended or stopped until that procedure has been terminated, unless it concerns a case of immediate urgency because of fraud or insolvency. If the recovery measures are suspended or stopped, the second subparagraph shall apply. Article PVAT.30 Amendment or withdrawal of the request for recovery assistance 1. The applicant authority shall inform the requested authority immediately of any subsequent amendment to its request for recovery or of the withdrawal of its request, indicating the reasons for amendment or withdrawal. 2. If the amendment of the request is caused by a decision of the competent body referred to in Article PVAT.29(1), the applicant authority shall communicate this decision together with a revised uniform instrument permitting enforcement in the State of the requested authority. The requested authority shall then proceed with further recovery measures on the basis of the revised instrument. Recovery or precautionary measures already taken on the basis of the original uniform instrument permitting enforcement in the State of the requested authority may be continued on the basis of the revised instrument, unless the amendment of the request is due to invalidity of the initial instrument permitting enforcement in the State of the applicant authority or the original uniform instrument permitting enforcement in the State of the requested authority. Articles PVAT.27 and PVAT.29 shall apply in relation to the revised instrument. Article PVAT.31 Request for precautionary measures 1. At the request of the applicant authority, the requested authority shall take precautionary measures, if allowed by its national law and in accordance with its administrative practices, to ensure recovery where a claim or the instrument permitting enforcement in the State of the applicant authority is contested at the time when the request is made, or where the claim is not yet the subject of an instrument permitting enforcement in the State of the applicant authority, in so far as precautionary measures are possible in a similar situation under the law and administrative practices of the State of the applicant authority. The document drawn up for permitting precautionary measures in the State of the applicant authority and relating to the claim for which mutual assistance is requested, if any, shall be attached to the request for precautionary measures in the State of the requested authority. This document shall not be subject to any act of recognition, supplementing or replacement in the State of the requested authority. 2. The request for precautionary measures may be accompanied by other documents relating to the claim. Article PVAT.32 Rules governing the request for precautionary measures In order to give effect to Article PVAT.31, Article PVAT.25(2), Article PVAT.28(1) and (2), Article PVAT.29 and Article PVAT.30 shall apply mutatis mutandis to requests under Article PVAT.31. Article PVAT.33 Limits to the requested authority's obligation 1. The requested authority shall not be obliged to grant the assistance provided for in Articles PVAT.25 to PVAT.31 if recovery of the claim would, because of the situation of the debtor, create serious economic or social difficulties in the State of the requested authority, in so far as the laws, regulations and administrative practices in force in that State allow such exception for national claims. 2. The requested authority shall not be obliged to grant the assistance provided for in Articles PVAT.25 to PVAT.31 where the costs or administrative burdens for the requested State would be clearly disproportionate to the monetary benefit to be derived by the applicant State. 3. The requested authority shall not be obliged to grant the assistance provided for in Article PVAT.20 and Articles PVAT.22 to PVAT.31 if the initial request for assistance pursuant to Article PVAT.20, PVAT.22, PVAT.23, PVAT.25 or PVAT.31 is made in respect of claims which are more than 5 years old, dating from the due date of the claim in the State of the applicant authority to the date of the initial request for assistance. However, in cases where the claim or the initial instrument permitting enforcement in the State of the applicant authority is contested, the 5-year period shall be deemed to begin from the moment when it is established in the State of the applicant authority that the claim or the instrument permitting enforcement may no longer be contested. Moreover, in cases where a postponement of the payment or payment by instalments arrangement has been granted by the State of the applicant authority, the 5-year period shall be deemed to begin from the moment when the entire extended payment period has come to its end. However, in those cases the requested authority shall not be obliged to grant assistance in respect of claims which are more than 10 years old, dating from the due date of the claim in the State of the applicant authority. 4. A State shall not be obliged to grant assistance if the total amount for which assistance is requested is less than GBP 5 000. 5. The requested authority shall inform the applicant authority of the grounds for refusing a request for assistance. Article PVAT.34 Questions on limitation 1. Questions concerning periods of limitation shall be governed solely by the laws in force in the State of the applicant authority. 2. In relation to the suspension, interruption or prolongation of periods of limitation, any steps taken in the recovery of claims by or on behalf of the requested authority in pursuance of a request for assistance which have the effect of suspending, interrupting or prolonging the period of limitation according to the laws in force in the State of the requested authority shall have the same effect in the State of the applicant authority, on condition that the corresponding effect is provided for under the law of the latter State. If suspension, interruption or prolongation of the period of limitation is not possible under the laws in force in the State of the requested authority, any steps taken in the recovery of claims by or on behalf of the requested authority in pursuance of a request for assistance which, if they had been carried out by or on behalf of the applicant authority in its own State, would have had the effect of suspending, interrupting or prolonging the period of limitation according to the laws of that State shall be deemed to have been taken in the latter State, in so far as that effect is concerned. The first and second subparagraphs shall not affect the right of the State of the applicant authority to take measures which have the effect of suspending, interrupting or prolonging the period of limitation in accordance with the laws in force in that State. 3. The applicant authority and the requested authority shall inform each other of any action which interrupts, suspends or prolongs the limitation period of the claim for which the recovery or precautionary measures were requested, or which may have this effect. Article PVAT.35 Costs 1. In addition to the amounts referred to in Article PVAT.28(5), the requested authority shall seek to recover from the person concerned and retain the costs linked to the recovery that it incurred, in accordance with the laws and regulations of its State. The States shall renounce all claims on each other for the reimbursement of costs arising from any mutual assistance they grant each other pursuant to this Protocol. 2. However, where recovery creates a specific problem, concerns a very large amount in costs or relates to organised crime, the applicant and requested authorities may agree reimbursement arrangements specific to the cases in question. 3. Notwithstanding paragraph 2, the State of the applicant authority shall be liable to the State of the requested authority for any costs and any losses incurred as a result of actions held to be unfounded, as far as either the substance of the claim or the validity of the instrument permitting enforcement and/or precautionary measures issued by the applicant authority are concerned. CHAPTER FOUR GENERAL RULES GOVERNING ALL TYPES OF RECOVERY ASSISTANCE REQUESTS Article PVAT.36 Use of languages 1. All requests for assistance, standard forms for notification and uniform instruments permitting enforcement in the State of the requested authority shall be sent in, or shall be accompanied by a translation into, the official language, or one of the official languages, of the State of the requested authority. The fact that certain parts thereof are written in a language other than the official language, or one of the official languages, of that State, shall not affect their validity or the validity of the procedure, in so far as that other language is one agreed between the States concerned. 2. The documents for which notification is requested pursuant to Article PVAT.23 may be sent to the requested authority in an official language of the State of the applicant authority. 3. Where a request is accompanied by documents other than those referred to in paragraphs 1 and 2, the requested authority may, where necessary, require from the applicant authority a translation of such documents into the official language, or one of the official languages of the State of the requested authority, or into any other language agreed between the States concerned. Article PVAT.37 Statistical data on recovery assistance 1. By 30 June each year, the Parties shall communicate by electronic means to the Specialised Committee the statistical data on the application of this Title. 2. The content and format of the statistical data to be communicated under paragraph 1 shall be determined by the Specialised Committee. Article PVAT.38 Standard forms and means of communication for recovery assistance 1. Requests pursuant to Article PVAT.20(1) for information, requests pursuant to Article PVAT.23(1) for notification, requests pursuant to Article PVAT.25(1) for recovery or requests pursuant to Article PVAT.31(1) for precautionary measures, and communication of statistical data pursuant to Article PVAT.37 shall be sent by electronic means, using a standard form, unless this is impracticable for technical reasons. As far as possible, these forms shall also be used for any further communication with regard to the request. The uniform instrument permitting enforcement in the State of the requested authority, the document permitting precautionary measures in the State of the applicant authority and the other documents referred to in Articles PVAT.27 and PVAT.31 shall also be sent by electronic means, unless this is impracticable for technical reasons. Where appropriate, the standard forms may be accompanied by reports, statements and any other documents, or certified true copies or extracts thereof, which shall also be sent by electronic means, unless this is impracticable for technical reasons. Standard forms and communication by electronic means may also be used for the exchange of information pursuant to Article PVAT.21. 2. Paragraph 1 shall not apply to the information and documentation obtained through the presence of officials in administrative offices in another State or through participation in administrative enquiries in another State, in accordance with Article PVAT.22. 3. If communication is not made by electronic means or with use of standard forms, this shall not affect the validity of the information obtained or of the measures taken in the execution of a request for assistance. 4. The electronic communication network and the standard forms adopted for the implementation of this Protocol may also be used for recovery assistance regarding other claims than the claims referred to in point (b) of Article PVAT.2(1), if such recovery assistance is possible under other bilateral or multilateral legally binding instruments on administrative cooperation between the States. 5. Pending the adoption by the Specialised Committee of the decisions referred to in Article PVAT.39(2), the competent authorities shall make use of the rules set out in the Annex to this Protocol, including the standard forms. 6. The State of the requested authority shall use its official currency for the transfer of the recovered amounts to the State of the applicant authority, unless otherwise agreed between the States concerned. TITLE IV IMPLEMENTATION AND APPLICATION Article PVAT.39 Trade Specialised Committee on Administrative Cooperation in VAT and Recovery of Taxes and Duties 1. The Specialised Committee shall: (a) hold regular consultations; and (b) review the operation and effectiveness of this Protocol at least every 5 years. 2. The Specialised Committee shall adopt decisions or recommendations to: (a) determine the frequency of, the practical arrangements for and the exact categories of information subject to automatic exchange referred to in Article PVAT.11; (b) review the result of the automatic exchange of information for each category established pursuant to point (a) so as to ensure that this type of exchange takes place only where it is the most efficient means for the exchange of information; (c) establish new categories of information to be exchanged pursuant to Article PVAT.11, should the automatic exchange be the most efficient means of cooperation; (d) define the standard forms for the communications pursuant to Articles PVAT.19(1) and PVAT.38(1); (e) review the availability, collection, and processing of statistical data referred to in Articles PVAT.18 and PVAT.37, so as to ensure that the obligations set out in those Articles do not impose a disproportionate administrative burden on the Parties; (f) establish what shall be transmitted via the CCN/CSI network or other means; (g) determine the amount and the modalities of the financial contribution to be made by the United Kingdom to the general budget of the Union in respect of the cost generated by its participation in the European information systems, taking into account the decisions referred to in points (d) and (f); (h) establish implementing rules on the practical arrangements with regard to the organisation of the contacts between the central liaison offices and liaison departments referred to in Article PVAT.4(2) and (3); (i) establish the practical arrangements between the central liaison offices for the implementation of Article PVAT.4(5); (j) establish implementing rules for Title III, including rules on the conversion of the sums to be recovered and the transfer of sums recovered; and (k) establish the procedure for concluding the service level agreement referred to in Article PVAT.5 and also conclude that service level agreement. TITLE V FINAL PROVISIONS Article PVAT.40 Execution of on-going requests 1. Where requests for information and for administrative enquiries sent in accordance with Regulation (EU) No 904/2010 in relation to the transactions covered by Article 99(1) of the Withdrawal Agreement are not yet closed within four years after the end of the transition period, the requested State shall ensure that those requests are executed in accordance with the rules of this Protocol. 2. Where assistance requests relating to taxes and duties within the scope of Article PVAT.2 of this Protocol sent in accordance with Directive 2010/24/EU in relation to the claims referred to in Article 100(1) of the Withdrawal Agreement are not closed within five years after the end of the transition period, the requested State shall ensure that those assistance requests are executed in accordance with the rules of this Protocol. The standard uniform form for notification or the instrument permitting enforcement in the requested State established in accordance with the legislation referred to in this paragraph shall retain its validity for the purposes of such execution. A revised uniform instrument permitting enforcement in the requested State may be established after the end of that five year period in relation to claims for which assistance was requested before that time. Such revised uniform instruments shall refer to the legal basis used for the initial assistance request. Article PVAT.41 Relation to other agreements or arrangements This Protocol shall take precedence over the provisions of any bilateral or multilateral agreements or arrangements on administrative cooperation in the field of VAT, or on recovery assistance relating to the claims covered by this Protocol, which have been concluded between Member States and the United Kingdom, insofar as their provisions are incompatible with those of this Protocol. (1) For greater certainty and in particular for the purposes of this Protocol, it is understood that the term \"person\" includes any association of persons lacking the legal status of a legal person but recognized under applicable law as having the capacity to perform legal acts. It also includes any other legal arrangement of whatever nature and form, having legal personality or not, which conducts transactions which are subject to VAT or which is liable for the payment of the claims referred to in point (b) of Article PVAT.2(1) of this Protocol. ANNEX TO THE PROTOCOL ON ADMINISTRATIVE COOPERATION AND COMBATING FRAUD IN THE FIELD OF VALUE ADDED TAX AND ON MUTUAL ASSISTANCE FOR THE RECOVERY OF CLAIMS RELATING TO TAXES AND DUTIES SECTION 1 Pending the adoption by the Specialised Committee of the decisions referred to in Article PVAT.39(2) of this Protocol, the following rules and standard forms apply. SECTION 2 ORGANISATION OF CONTACTS 2.1. Until further notice, the central liaison offices having the principal responsibility for the application of Title II of this Protocol are: (a) for the United Kingdom: Her Majesty's Revenue and Customs, UK VAT Central Liaison Office; (b) for the Member States: the central liaison offices designated for administrative cooperation between the Member States in the area of VAT. 2.2. Until further notice, the central liaison offices having the principal responsibility for the application of Title III of this Protocol are: (a) for the United Kingdom: Her Majesty's Revenue and Customs, Debt Management; (b) for the Member States: the central liaison offices designated for recovery assistance between the Member States. SECTION 3 ADMINISTRATIVE COOPERATION AND COMBATING FRAUD IN THE FIELD OF VALUE ADDED TAX 3.1. Communication The communication of information under Title II of this Protocol shall be done, as far as possible, by electronic means and via the Common Communication Network (CCN), between the respective mailboxes of the States for the exchange of information on administrative cooperation or the mailboxes for combating fraud in the field of VAT. 3.2. Standard form For the exchange of information under Title II of this Protocol, the States shall use the following model: Standard form for requests for information, for spontaneous exchange of information and for feedback between EU Member States and the United Kingdom under the Protocol on administrative cooperation and combating fraud in the area of VAT Exchange of information reference: A) BASIC INFORMATION A1 Requesting State: Requested State: Requesting authority: Requested authority: A2 Official dealing with the request/exchange in the requesting authority: Official dealing with the reply to the request/exchange in the requested authority: Name: Name: Email: Email: Telephone: Telephone: Language: Language: A3 Requesting authority national reference: Requested authority national reference: Space reserved for the requesting authority: Space reserved for the requested authority: A4 Date of transmission of the request/exchange: Date of transmission of the reply: A5 No of attachments to the request/exchange: No of attachments to the reply: A6 A7 o General request/exchange \u2610 I, requested authority, will not be able to reply within the following deadlines: o Request for information o 3 months o Spontaneous exchange of information o 1 month for information that is already in my possession \u2610 Feedback on spontaneous exchange of information is requested Reason for delay: o Anti-fraud request/exchange o Request for information o Missing Trader Fraud - Registration control/Business activity o Spontaneous supply of information \u2610 Feedback on spontaneous information is requested \u2610 Expected time of reply: \u2610 The requested authority of the State authorises the transmission of the information to another State (Article PVAT.6(6) of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties) \u2610 Feedback on the reply is requested Pursuant to Article PVAT.6(4) of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties, the State providing the information shall, on the basis of a reasoned request, permit the use of the information received for purposes other than those referred to in Article 2(1) of that Protocol. B) REQUEST FOR GENERAL INFORMATION Requesting authority Requested authority Requested authority (1) B1 VAT identification number (if not, tax identification number) B1 VAT identification number (if not, tax identification number) o Please fill in o Please confirm o I confirm o I do not confirm VAT number: VAT number: VAT number: \u2610 VAT number not available \u2610 VAT number not available \u2610 VAT number not available Tax identification number: Tax identification number: Tax identification number: B2 Name B2 Name o Please fill in o Please confirm o I confirm o I do not confirm Name: B3 Trading name B3 Trading name o Please fill in o Please confirm o I confirm o I do not confirm Trading name: B4 Address B4 Address o Please fill in o Please confirm o I confirm o I do not confirm Address: B5 The following dates in the format (YYYY/MM/DD): B5 The following dates in the format (YYYY/MM/DD): o Please fill in o Please confirm o I confirm o I do not confirm (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (c) Incorporation (c) Incorporation (c) Incorporation B6 Date of commencement of activity B6 Date of commencement of activity o Please fill in o Please confirm o I confirm o I do not confirm Date of commencement of activity Date of commencement of activity B7 Date of cessation of activity B7 Date of cessation of activity o Please fill in o Please confirm o I confirm o I do not confirm Date of cessation of activity Date of cessation of activity B8 Names of the managers/directors B8 Names of the managers/directors o Please fill in o Please confirm o I confirm o I do not confirm B9 Names of the owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business B9 Names of the owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business o Please fill in o Please confirm o I confirm o I do not confirm B10 Nature of the activity B10 Nature of the activity o Please fill in o Please confirm o I confirm o I do not confirm (a) Legal status of the business (a) Legal status of the business (a) Legal status of the business (b) Actual principal activity (2) (b) Actual principal activity (b) Actual principal activity B11 Nature of the transaction Nature of the transaction B11 Goods/services involved o Please fill in Nature of the transaction B11 Goods/services involved o Please confirm o I confirm o I do not confirm Period and amount to which the request/exchange relates B12 Supply of goods from one country to another From Period Period To Amount Amount Sources: \u2610 VAT information exchange system (VIES) \u2610 Other B13 Supply of services from one country to another From Period Period To Amount Amount Sources: \u2610 VIES \u2610 Other C) ADDITIONAL INFORMATION Registration \u2610 C1 The taxable person in the requested State (\u2610)/ the taxable person in the requesting State (\u2610) is currently not identified for VAT purposes. According to the VIES or other sources, supplies have been made after the date of cessation of the activity. Please explain. \u2610 C2 The taxable person in the requested State (\u2610) / the taxable person in the requesting State (\u2610) is not identified for VAT purposes. According to the VIES or other sources, supplies have been made before the date of registration. Please explain. Transactions of goods/services Goods \u2610 C3 According to the VIES or other sources, the taxable person in the requested State made supplies of goods but the taxable person in the requesting State either: o did not declare a purchase of the goods; o denies receipt of the goods; o declared a purchase for a different amount and the declared amount is: Please investigate and explain. \u2610 I attach copies of documents in my possession. \u2610 C4 The purchase declared by the taxable person in the requesting State does not correspond with the information from VIES or other sources. Please investigate and explain. \u2610 C5 Please provide the addresses where the goods were delivered. Addresses: \u2610 C6 The taxable person in the requesting State claims to have made supply to a person in the requested State. Please confirm that the goods were received and whether they were: \u2610 accounted for: o Yes o No \u2610 declared/paid by a taxable person in the requested State o Yes o No Name and/or VAT identification number of the taxable person in the requested State. Prior/onward movement of the goods \u2610 C7 From whom were the goods purchased? Please provide names, trading names and VAT numbers in box C41. \u2610 C8 To whom were the goods sold on? Please provide names, trading names and VAT numbers in box C41. Services \u2610 C9 According to the VIES or other sources, the taxable person in the requested State made supplies of services taxable in the requesting State but the taxable person in the requesting State either: o did not declare the service; o denies having received the service; o declared having receiving the service for a different amount and the declared amount is: Please investigate and explain. \u2610 I attach copies of documents in my possession. \u2610 C10 The a purchase declared by the taxable person in the requesting State do not correspond with the information from the VIES or other sources. Please investigate and explain. \u2610 C11 Please provide the addresses where the services were provided. Addresses: \u2610 C12 The taxable person in the requesting State claims to have made supply to a person in the requested State. Please confirm that the services were provided and whether they were: \u2610 accounted for: o Yes o No \u2610 declared/paid by a taxable person in the requested State o Yes o No Name and/or VAT identification number of the taxable person in the requested State. Transport of goods \u2610 C13 Please provide the name/VAT identification number and the address of the transporter. Name and/or VAT identification number and address: \u2610 C14 Who ordered and paid the transportation of the goods? Name and/or VAT identification number and address: \u2610 C15 Who is the owner of the means of transport used? Name and/or VAT identification number and address: Invoices \u2610 C16 Please provide the amount invoiced and currency. Payment \u2610 C17 Please provide the amount paid and currency. \u2610 C18 Please provide the name of the bank account holder and the number of the account from which and/or to which the payment was made. From: Name of the account holder: IBAN number or account number: Bank: To: Name of the account holder: IBAN number or account number: Bank: \u2610 C19 Please provide the following details where the payment was made in cash: \u2610 Who handed over the money, to whom, where and when? \u2610 What document (cash receipt, etc.) was issued confirming the payment? \u2610 C20 Is there any evidence of third party payments? If yes, please provide additional information in box C41 o Yes o No Placing of an order \u2610 C21 Please furnish all available details of the person placing the order, how the order was placed and how the contact was established between the supplier and the customer. Goods covered by special schemes/particular procedures Please tick the appropriate box and enter your question in box C40 \u2610 C22 Triangular transactions. \u2610 C23 Margin scheme. \u2610 C24 Distance sales of goods \u2610 covered by the Union scheme \u2610 covered by the Import scheme \u2610 C25 New means of transport sold to non-taxable persons. \u2610 C26 Exemption under Customs Procedure 42XX / 63XX. \u2610 C27 Gas and electricity. \u2610 C28 Call-off stock arrangements. \u2610 C29 Others: Services covered by particular provisions Please tick the appropriate box and enter your question in box C40 \u2610 C30 Supply of services provided by an intermediary. \u2610 C31 Supply of services connected to immovable property. \u2610 C32 Supplies of passenger transport. \u2610 C33 Supplies of transport of goods. \u2610 C34 Supply of cultural, artistic, sporting, scientific, educational, entertainment and similar services, ancillary transport services and valuations of and work on movable tangible property. \u2610 C35 Supply of restaurant and catering services other than as provided for at C37. \u2610 C36 Supply of transport hire. \u2610 C37 Supply of restaurant and catering services for consumption on board of ships, aircraft or trains. \u2610 C38 Supply of services \u2610 covered by the non-Union scheme \u2610 covered by the Union scheme \u2610 C39 Services for which effective use and enjoyment rules are applied. \u2610 C40 Background information and further questions C41 Free text reply box D) REQUEST FOR DOCUMENTS Please provide copies of the following documents (where applicable see amount and period in part B12 and B13) \u2610 D1 Invoices o Provided o Not available \u2610 D2 Contracts o Provided o Not available \u2610 D3 Orders o Provided o Not available \u2610 D4 Evidence of payments o Provided o Not available \u2610 D5 Transport documentation o Provided o Not available \u2610 D6 Creditor's ledger for the taxable person in the requested State o Provided o Not available \u2610 D7 Debtor's ledger for the taxable person in the requested State o Provided o Not available \u2610 D8 Call-off stock registers From To o Provided o Not available \u2610 D9 One-stop-shop/import one-stop-shop records From To o Provided o Not available \u2610 D10 Bank account statements From To o Provided o Not available \u2610 D11 Others o Provided o Not available E) SPONTANEOUS SUPPLY OF INFORMATION (GENERAL) \u2610 E1 Based on the records of the taxable person in the sending State, it appears that they should be registered in the receiving State. \u2610 E2 According to the records of the taxable person in the sending State, \u2610 goods / \u2610 services were supplied to them by a taxable person in the receiving State, but no information is available via the VIES/Customs or other sources data. \u2610 E3 According to the records of the taxable person in the sending State, VAT is to be paid on goods supplied to the receiving State, but no data was entered into VIES/Customs or other sources data. \u2610 E4 According to the VIES/Customs or other sources data, the taxable person in the receiving State made supplies to a taxable person in the sending State but the latter taxable person either: \u2610 did not declare a purchase of \u2610 goods / receipt of \u2610 services; \u2610 denies the purchase of the \u2610 goods / receipt of \u2610 services. \u2610 E5 According to the records of the taxable person in the sending State, VAT is to be paid on services supplied in the receiving State. \u2610 E6 Background and additional information: \u2610 E7 I attach copies of invoices in my possession. F) MISSING TRADER FRAUD: REGISTRATION CONTROL / BUSINESS ACTIVITY (A) Identification of the business Requesting authority Requested authority Requested authority (3) F1 VAT identification number (if not, tax identification number) F1 VAT identification number (if not, tax identification number) o Please fill in o Please confirm o I confirm o I do not confirm VAT number: VAT number: VAT number: \u2610 VAT number not available \u2610 VAT number not available \u2610 VAT number not available Tax identification number: Tax identification number: Tax identification number: F2 Name F2 Name o Please fill in o Please confirm o I confirm o I do not confirm Name: F3 Address F3 Address o Please fill in o Please confirm o I confirm o I do not confirm Address: F4 The following dates in the format (YYYY/MM/DD): F4 The following dates in the format (YYYY/MM/DD): o Please fill in o Please confirm o I confirm o I do not confirm (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (c) Incorporation (c) Incorporation (c) Incorporation F5 Owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business F5 Owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business o Please fill in o Please confirm o I confirm o I do not confirm (a) Name (a) Name (a) Name (b) Address (b) Address (b) Address (c) Date of birth (c) Date of birth (c) Date of birth (d) Nationality (d) Nationality (d) Nationality F6 Managers/directors F6 Managers/directors o Please fill in o Please confirm o I confirm o I do not confirm (a) Name (a) Name (a) Name (b) Address (b) Address (b) Address (c) Date of birth (c) Date of birth (c) Date of birth (d) Nationality (d) Nationality (d) Nationality (B) Information requested \u2610 F7 Are the persons referred to in F5 and F6 (with date of birth if known) contained in any of your databases? o Yes o No \u2610 F8 Do those persons referred to in F5 and F6 have a financial criminal record? \u2610 The information cannot be given for legal reasons. o Yes o No \u2610 F9 Do those persons referred to in F5 and F6 have a history of involvement in missing trader fraud or other type of fraud? \u2610 The information cannot be given for legal reasons. o Yes o No \u2610 F10 Are those persons referred to in F5 and F6 either resident at or connected with the address given? o Yes o No \u2610 F11 Is the stated address residential/business/temporary accommodation/accountant/other? o Yes o No \u2610 F12 What is the business activity? \u2610 F13 Is the business's tax compliance suspect? o Yes o No \u2610 F14 What is the reason for the cancellation of the VAT number? \u2610 F15 Please advise of any associated business (4) including their VAT identification numbers and any views as to their credibility. \u2610 F16 Please provide details of known bank accounts of the business in the requested State and any associated businesses. \u2610 F17 Please provide information from recapitulative statements or from Customs declarations on the supplies/purchases of goods/services for the year(s): \u2610 F18 Please provide information from VAT declarations/about payments for the year(s): \u2610 F19 Any additional comments: G) SPONTANEOUS SUPPLY OF INFORMATION (MISSING TRADER FRAUD) Sending authority Receiving authority Identification of the business G1 VAT identification number (if not, tax identification number) Identification of the business G1 VAT identification number (if not, tax identification number) VAT number: VAT number: \u2610 VAT number not available \u2610 VAT number not available Tax identification number: Tax identification number: G2 Name G2 Name G3 Address G3 Address G4 The following dates in the format (YYYY/MM/DD): G4 The following dates in the format (YYYY/MM/DD): (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (c) Incorporation (c) Incorporation G5 Owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business G5 Owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business (a) Name (a) Name (b) Address (b) Address (c) Date of birth (c) Date of birth (d) Nationality (d) Nationality G6 Managers, directors G6 Managers, directors (a) Name (a) Name (b) Address (b) Address (c) Date of birth (c) Date of birth (d) Nationality (d) Nationality Any additional comments H) FEEDBACK (5) Results related to the information provided: 1) The information provided: \u2610 Resulted in an additional assessment of VAT or of other taxes. Please provide details on the type and amount of tax assessed: Type of tax: Additional assessment: Penalty: \u2610 Resulted in VAT registration. \u2610 Resulted in VAT deregistration. \u2610 Resulted in the cancellation of a VAT number from VIES or from VAT registered taxpayer's database. \u2610 Resulted in the correction of VAT declarations. \u2610 Led to a desk enquiry. \u2610 Led to a new audit procedure or was used as part of an on-going audit. \u2610 Led to a fraud investigation. \u2610 Resulted in a request for information. \u2610 Led to a presence in administrative office or to participation in administrative enquiry. \u2610 Led to Multilateral control (MLC). \u2610 Resulted in other actions: \u2610 Did not result in any substantial action. 2) Other comments: Date of transmission: SECTION 4 RECOVERY ASSISTANCE Article 4.1 Communication A request sent by electronic means for the application of Title III of this Protocol shall be sent between the CCN mailboxes that are set up for the type of tax or duty to which the request relates, unless the central liaison offices of the applicant and requested States agree that one of the mailboxes can be used for requests concerning different types of taxes or duties. However, if a request for notification of documents relates to more than one type of tax or duty, the applicant authority shall send that request to a mailbox set up for at least one of the types of claims mentioned in the documents to be notified. Article 4.2 Implementing rules relating to the uniform instrument permitting enforcement in the requested State 1. The administrative penalties, fines, fees and surcharges and the interest and costs referred to in point (b) of Article PVAT.2(1) of this Protocol which, in accordance with the rules in force in the applicant State, may be due from the date of the initial instrument permitting enforcement until the day before the date on which the recovery request is sent, may be added in the uniform instrument permitting enforcement in the requested State. 2. A single uniform instrument permitting enforcement in the requested State may be issued in respect of several claims and several persons, corresponding to the initial instrument or instruments permitting enforcement in the applicant State. 3. In so far as initial instruments permitting enforcement for several claims in the applicant State have already been replaced by a global instrument permitting enforcement for all those claims in that State, the uniform instrument permitting enforcement in the requested State may be based on the initial instruments permitting enforcement in the applicant State or on that global instrument regrouping those initial instruments in the applicant State. 4. Where the initial instrument referred to in paragraph 2 or the global instrument referred to in paragraph 3 contains several claims, one or more of which have already been collected or recovered, the uniform instrument permitting enforcement in the requested State shall only refer to those claims for which recovery assistance is requested. 5. Where the initial instrument referred to in paragraph 2 or the global instrument referred to in paragraph 3 contains several claims, the applicant authority may list those claims in different uniform instruments permitting enforcement in the requested State, in line with the tax type related division of competences of the respective recovery offices in the requested State. 6. If a request cannot be transmitted by CCN network and is transmitted by post, the uniform instrument permitting enforcement in the requested State shall be signed by a duly authorised official of the applicant authority. Article 4.3 Conversion of the sums to be recovered 1. The applicant authority shall express the amount of the claim to be recovered in the currency of the applicant State and in the currency of the requested State. 2. For requests sent to the United Kingdom, the exchange rate to be used for the purposes of the recovery assistance shall be the exchange rate published by the European Central Bank on the day before the date on which the request is sent. Where there is no such rate available on that date, the exchange rate used shall be the latest exchange rate published by the European Central Bank before the date the request is sent. For requests sent to a Member State, the exchange rate to be used for the purposes of the recovery assistance shall be the exchange rate published by the Bank of England on the day before the date on which the request is sent. Where there is no such rate available on that date, the exchange rate used shall be the latest exchange rate published by the Bank of England before the date the request is sent. 3. In order to convert the amount of the claim resulting from the adjustment referred to in Article PVAT.30(2) of this Protocol into the currency of the State of the requested authority, the applicant authority shall use the exchange rate used in its initial request. Article 4.4 Transfer of recovered amounts 1. The transfer of the recovered amounts shall take place within two months of the date on which recovery was effected, unless otherwise agreed between the States. 2. However, if recovery measures applied by the requested authority are contested for a reason not falling within the responsibility of the applicant State, the requested authority may wait to transfer any sums recovered in relation to the applicant State's claim, until the dispute is settled, if the following conditions are simultaneously fulfilled: (a) the requested authority finds it likely that the outcome of this contestation will be favourable to the party concerned; and (b) the applicant authority has not declared that it will reimburse the sums already transferred if the outcome of that contestation is favourable to the party concerned. 3. If the applicant authority has made a declaration to reimburse in accordance with point (b) of the paragraph 2, it shall return the recovered amounts already transferred by the requested authority within one month of the receipt of the request for reimbursement. Any other compensation due shall, in that case, be borne solely by the requested authority. Article 4.5 Reimbursement of recovered amounts The requested authority shall notify any action taken in the requested State for reimbursement of sums recovered or for compensation in relation to recovery of contested claims to the applicant authority immediately after the requested authority has been informed of such action. The requested authority shall as far as possible involve the applicant authority in the procedures for settling the amount to be reimbursed and the compensation due. Upon receipt of a reasoned request from the requested authority, the applicant authority shall transfer the sums reimbursed and the compensation paid within two months of the receipt of that request. Article 4.6 Standard forms 1. For the uniform notification form accompanying the request for notification, referred to in Article PVAT.23 of this Protocol, the States shall use the form established in accordance with model A. 2. For the uniform instrument permitting enforcement in the requested State, referred to in Article PVAT.27 of this Protocol, accompanying the request for recovery or the request for precautionary measures, or the revised uniform instrument permitting enforcement in the requested State, referred to in Article PVAT.30(2) of this Protocol, the States shall use the form established in accordance with model B. 3. For the request for information referred to in Article PVAT.20 of this Protocol, the States shall use the form established in accordance with model C. 4. For the request for notification referred to in Article PVAT.23 of this Protocol, the States shall use the form established in accordance with model D. 5. For the request for recovery or for precautionary measures referred to in Articles PVAT.25 and PVAT.31 of this Protocol, the States shall use the form established in accordance with model E. 6. Where forms are transmitted by electronic means, their structure and lay-out may be adapted to the requirements and possibilities of the electronic communication system, provided that the set of data and information contained therein is not substantially altered when compared to the models set out below. Model A Uniform notification form providing information about notified document(s) (to be transmitted to the addressee of the notification)( 1 ) This document accompanies document(s) hereby notified by the competent authority of the following State: [name of requested State]. This notification concerns documents of the competent authorities of the following State: [name of applicant State], which asked for notification assistance, in accordance with Article PVAT.23 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom. A. ADDRESSEE OF THE NOTIFICATION \u2013 Name \u2013 Address (known or assumed) \u2013 Other data relevant to the identification of the addressee B. PURPOSE OF THE NOTIFICATION This notification is intended: \u2610 to inform the addressee about the document(s) to which this document is attached \u2610 to interrupt the period of limitation with regard to the claim(s) mentioned in the notified document(s). \u2610 to confirm to the addressee, his/her obligation to pay the amounts mentioned under point D. Please note that in case of non-payment, the authorities may take enforcement and/or precautionary measures to ensure the recovery of the claim(s). This may cause extra costs charged to the addressee. You are the addressee of this notification, as you are considered to be: \u2610 the principal debtor \u2610 a co-debtor \u2610 a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures, under the laws in force in the applicant State \u2610 a person other than the (co-)debtor, holding assets belonging to, or having debts towards, the (co-)debtor or to any other person liable \u2610 a third party which may become affected by enforcement measures concerning other persons (The following information will appear if the addressee of the notification is a person other than the (co-)debtor, holding assets belonging to, or having debts towards, the (co-)debtor or to any other person liable, or a third party which may become affected by enforcement measures concerning other persons: The notified documents concern claims relating to taxes and duties, for which the following person(s) is (are) liable as \u2610 the principal debtor: [name and address (known or assumed)] \u2610 a co-debtor: [name and address (known or assumed)] \u2610 a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures, under the laws in force in the applicant State: [name and address (known or assumed)]). The applicant authority of the applicant State [name of the applicant State] invited the competent authorities of the requested State [name of the requested State] to make this notification before [date]. Please note that this date is not specifically related to any period of limitation. C. OFFICE(S) RESPONSIBLE FOR THE NOTIFIED DOCUMENT(S) Office responsible with regard to the attached document(s): \u2013 Name: \u2013 Address: \u2013 Other contact details: \u2013 Language(s) in which this office can be contacted: Further information about \u2610 the notified document(s) \u2610 and/or the possibility of contesting the obligations can be obtained \u2610 at the abovementioned office responsible with regard to the attached document(s), and/or \u2610 from the following office: \u2013 Name: \u2013 Address: \u2013 Other contact details: \u2013 Language(s) in which this office can be contacted: D. DESCRIPTION OF THE NOTIFIED DOCUMENT(S) Document [number] \u2013 Reference number: \u2013 Date of establishment: \u2013 Nature of the notified document: \u2610 Tax assessment \u2610 Payment order \u2610 Decision following an administrative appeal \u2610 Other administrative document: \u2610 Judgment or order of: \u2610 Other judicial document: \u2013 Name of the claim(s) concerned (in the language of the applicant State): \u2013 Nature of the claim(s) concerned: \u2013 Amount of the claim(s) concerned: \u2610 Principal amount: \u2610 Administrative penalties and fines: \u2610 Interest up to [date]: \u2610 Costs up to [date]: \u2610 Fees for certificates and similar documents issued in connection with administrative procedures related to the claim mentioned under point [x]: \u2610 Total amount for this (these) claim(s): \u2013 The amount mentioned under point [x] should be paid: \u2610 before: \u2610 within [number] days following the date of this notification \u2610 without any further delay \u2013 This payment should be made to: \u2013 Holder of the bank account: \u2013 International Bank Account Number (IBAN): \u2013 Bank Identification Code (BIC): \u2013 Name of the bank: \u2013 Reference to be used for the payment: \u2013 The addressee can reply to the document(s) that is (are) hereby notified. \u2610 Last day for replying: \u2610 Time period for replying: \u2013 Name and address of the authority to whom a reply can be sent: \u2013 Possibility of contesting: \u2610 The period to contest the claim or the notified document(s) has already come to its end. \u2610 Last day for contesting the claim: \u2610 Time period to contest the claim: [number of days] following \u2610 the date of this notification. \u2610 the establishment of the notified document(s) \u2610 another date: \u2013 Name and address of the authority where a contestation has to be submitted: Please note that disputes concerning the claim, the instrument permitting enforcement or any other document originating from the authorities of the applicant State [name of applicant State], fall within the competence of the competent bodies of the applicant State [name of applicant State], in accordance with Article PVAT.29 of the above Protocol between the European Union and the United Kingdom. Any such dispute is governed by the procedural and language rules applying in the applicant State [name of applicant State]. \u2610 Please note that the recovery may begin before the end of the period within which the claim may be contested. \u2013 Other information: ______________ (1) The elements in italics are optional. Model B Uniform instrument permitting enforcement of claims covered by Article PVAT.27 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom(1) \u2610 UNIFORM INSTRUMENT PERMITTING ENFORCEMENT OF CLAIMS \u2013 Date of issue: \u2013 Reference number: \u2610 REVISED UNIFORM INSTRUMENT PERMITTING ENFORCEMENT OF CLAIMS \u2013 Date of issue of the original uniform instrument: \u2013 Date of revision: \u2013 Reason for the revision: \u2610 judgment or order of [name of the Court] of [date] \u2610 administrative decision of [date] \u2013 Reference number: State where this document is issued: [name of applicant State] Recovery measures taken by the requested State are based on: \u2610 a uniform instrument permitting enforcement, in accordance with Article PVAT.27 of the above Protocol. \u2610 a revised uniform instrument permitting enforcement, in accordance with Article PVAT.30 of the above Protocol (to take account of the decision of the competent body referred to in Article PVAT.29(1) of that Protocol). This document is the uniform instrument permitting enforcement (including precautionary measures). It concerns the claim(s) mentioned below, which remain(s) unpaid in the applicant State [name of applicant State]. The initial instrument for the enforcement of this/these claim(s) has been notified in so far as required under the national law of the applicant State [name of applicant State]. Disputes concerning the claim(s) fall exclusively within the competence of the competent bodies of the applicant State [name of applicant State], in accordance with Article PVAT.29 of the above Protocol. Any such action shall be brought before them in accordance with the procedural and language rules in force in the applicant State [name of applicant State]. DESCRIPTION OF THE CLAIM(S) AND THE PERSON(S) CONCERNED Identification of the claim(s) [number] 1. Reference: 2. Nature of the claim(s) concerned: 3. Name of the tax/duty concerned: 4. Period or date concerned: 5. Date of establishment of the claim: 6. Date on which enforcement becomes possible: 7. Amount of the claim still due: \u2610 principal amount: \u2610 administrative penalties and fines: \u2610 interest till date before the day the request is sent: \u2610 costs till date before the day the request is sent: \u2610 total amount of this claim: 8. Date of notification of the initial instrument permitting enforcement in the applicant State: [name of the applicant State]: \u2610 Date: \u2610 No date available 9. Office responsible for the assessment of the claim: \u2013 Name: \u2013 Address: \u2013 Other contact details: \u2013 Language(s) in which this office can be contacted: 10. Further information concerning the claim or the possibilities for contesting the payment obligation can be obtained from: \u2610 the office indicated above \u2610 the following office responsible for the Uniform instrument permitting enforcement: \u2013 Name: \u2013 Address: \u2013 Other contact details: \u2013 Language(s) in which this office can be contacted: Identification of the person(s) concerned in the national instrument(s) permitting enforcement (a) The following person is mentioned in the national instrument(s) permitting enforcement \u2610 natural person \u2610 other \u2013 Name \u2013 Address (known or assumed) \u2013 Other data relevant to the identification of the addressee \u2610 Legal representative \u2013 Name \u2013 Address (known or assumed) \u2013 Other data relevant to the identification of the addressee Cause of liability: \u2610 principal debtor \u2610 a co-debtor \u2610 a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures under the laws in force in the applicant State (b) the following person(s) is (are) also mentioned in the national instrument(s) permitting enforcement: \u2610 natural person \u2610 other \u2013 Name: \u2013 Address (known or assumed): \u2013 Other data relevant to the identification of the addressee: \u2610 Legal representative \u2013 Name: \u2013 Address (known or assumed): \u2013 Other data relevant to the identification of the addressee: Cause of liability: \u2610 principal debtor \u2610 a co-debtor \u2610 a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures under the laws in force in the applicant State Other information Overall total amount of the claim(s) \u2013 in the currency of the applicant State: \u2013 in the currency of the requested State: _____________ (1) The elements in italics are optional. Model form C \u2013 request for information REQUEST FOR INFORMATION Based on Article PVAT.20 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom Reference: AA_RA_aaaaaaaaaaa_rrrrrrrrrrrr_20YYMMDD_xxxxxxx_RI Nature of the claim(s): 1. STATE OF THE APPLICANT AUTHORITY A. Applicant authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills B. Office initiating the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 2. STATE OF THE REQUESTED AUTHORITY A. Requested authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills B. Office handling the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 3. INFORMATION RELATING TO THE REQUEST \u2610 I, applicant authority, ask the requested authority not to inform the person(s) concerned about this request. \u2610 I, applicant authority, confirm that the information to be received will be subject to the secrecy provisions defined in the legal basis quoted above. 4. INFORMATIONRELATING TO THE PERSON CONCERNED A. Information is requested with regard to: \u2610 For natural persons: First name(s): Surname: Maiden name (name at birth): Date of birth: Place of birth: VAT number: Tax Identification Number: Other identification data: Address of this person: \u2610 known \u2014 \u2610 assumed \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2014 Country: \u2610 Or for legal entities: Company name: Legal status: VAT number: Tax Identification Number: Other identification data: Address of this legal entity: \u2610 known \u2014 \u2610 assumed \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2014 Country: \u2610 Legal representative Name: Address of this legal representative: \u2610 known \u2014 \u2610 assumed \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2014 Country: B. Liability: the person concerned is: \u2610 the principal debtor \u2610 a co-debtor \u2610 a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures under the laws in force in the applicant State; \u2610 a person other than the (co-)debtor, holding assets belonging to, or having debts towards, the (co-)debtor or to any other person liable. \u2610 a third party which may become affected by enforcement measures concerning other persons. C. Other relevant information concerning the above persons: \u2610 Bank account number(s) \u2014 Bank account number (IBAN): \u2014 Bank identification code (BIC): \u2014 Name of the bank: \u2610 Car information on 20YY/MM/DD \u2014 car plate number: \u2014 car brand: \u2014 colour of the car: \u2610 Estimated or provisional or \u2610 precise amount of the claim(s): \u2610 Other: 5. INFORMATION REQUESTED \u2610 Information about the identity of the person concerned (for natural persons: full name, date and place of birth; for legal entities: company name and legal status) \u2610 Information about the address \u2610 Information about the income and assets for recovery \u2610 Information about the heirs and/or legal successors \u2610 Other: 6. FOLLOW-UP OF THE REQUEST FOR INFORMATION Date Nr Message Applicant authority Requested authority date 1 \u2610 I, requested authority, acknowledge receipt of the request. date \u2610 To be combined with acknowledgment 2 \u2610 I, requested authority, invite the applicant authority to complete the request with the following additional information: date 3 \u2610 I, requested authority, have not yet received the additional information required and will close your request if I do not receive this information before 20YY/MM/DD. date 4 I, applicant authority, \u2610 a provide on request the following additional information: \u2610 b am not able to provide the requested additional information (because:) date 5 \u2610 I, requested authority, acknowledge receipt of the additional information and am now in a position to proceed. date 6 I, requested authority, do not provide assistance and close the case because: \u2610 a I do not have competence for any of the claims to which the request relates. \u2610 b the claim is older than foreseen in the Protocol. \u2610 c the amount of the claim is below the threshold. \u2610 d I am not able to obtain this information for the purpose of recovering similar national claims. \u2610 e this would disclose a commercial, industrial or professional secret. \u2610 f the disclosure of this information would be liable to prejudice the security or be contrary to the public policy of the State. \u2610 g the applicant authority did not provide all the required additional information \u2610 h other reason: date 7 \u2610 I, applicant authority, ask to be informed about the present status of my request. date 8 I, requested authority, cannot provide the information now because: \u2610 I have asked information from other public bodies. \u2610 I have asked information from a third party. \u2610 I am arranging a personal call. \u2610 other reason: date 9 The requested information cannot be obtained because: \u2610 a the person concerned is not known. \u2610 b insufficient data for identification of person concerned. \u2610 c the person concerned has moved away, address unknown. \u2610 d the requested information is not available. \u2610 e other reason: date 10 \u2610 I, requested authority, transmit the following part of the requested information: date 11 I, requested authority, transmit all (or the final part of) the requested information: \u2610 a Identity confirmed \u2610 b Address confirmed \u2610 c The following data about the identity of the person concerned have changed (or are added): For natural persons: \u2610 First name(s): \u2610 Surname: \u2610 Maiden name: \u2610 Date of birth: \u2610 Place of birth: For legal entities: \u2610 Legal Status: \u2610 Company name: \u2610 d The following address data have changed (or are added): \u2610 Street and no.: \u2610 Details of address: \u2610 Postcode and town: \u2610 Country: \u2610 Telephone: \u2610 Fax: \u2610 E-mail: \u2610 e Financial situation: \u2610 Bank account(s) known: Bank account number (IBAN): \u2026 Bank identification code (BIC): \u2026 Name of the bank: \u2026 \u2610 Employment details: \u2610 Employee \u2014\u2610 Self-employed \u2014 \u2610 Unemployed \u2610 It seems that the person concerned has no means to settle the debt/no assets to cover recovery \u2610 The person concerned is bankrupt/insolvent: \u2014 Date of order: \u2014 Date of release: \u2014 Liquidators details: Name: Street and no: Details of address: Postcode and town: Country: \u2610 It seems that the person concerned has: \u2610 limited means to partially settle the debt \u2610 sufficient means/assets for recovery \u2610 Comments: \u2610 f Debt disputed \u2610 person concerned has been advised to contest the claim in the State of the applicant authority \u2610 references of the dispute, if available: \u2610 further details attached \u2610 g Debtor deceased on YYYY/MM/DD \u2610 h Name and address of heirs/will executor: \u2610 i Other comments: \u2610 j I recommend proceeding with recovery procedures \u2610 k I recommend not proceeding with recovery procedures date 12 \u2610 I, applicant authority, withdraw my request for information. date 13 \u2610 Other: comment from o applicant authority or o requested authority: Model form D \u2013 request for notification REQUEST FOR NOTIFICATION Based on Article PVAT.23 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom Reference: AA_RA_aaaaaaaaaaa_rrrrrrrrrrrr_20YYMMDD_xxxxxxx_RN Nature of the claim(s): 1. STATE OF THE APPLICANT AUTHORITY A. Applicant authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills: B. Office initiating the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 2. STATE OF THE REQUESTED AUTHORITY A. Requested authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills: B. Office handling the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 3. INFORMATION RELATING TO THE REQUEST \u2610 Final date for notification of these documents in order to avoid problems with the limitation period (if necessary): 20YY/MM/DD \u2610 Other comments: 4. IDENTIFICATION OF THE ADDRESSEE OF THE NOTIFICATION A. The notification should be made to: \u2610 For natural persons: First name(s): Surname: Maiden name (name at birth): Date of birth: Place of birth: VAT number: Tax Identification Number: Other identification data: Address of this person: \u2610 known \u2014 \u2610 assumed: Street and number: Details of address: Postcode and town: Country: \u2610 Or for legal entities: Company name: Legal status: VAT number: Tax Identification Number: Other identification data: Address of this legal entity: \u2610 known \u2014 \u2610 assumed Street and number: Details of address: Postcode and town: Country: \u2610 Legal representative Name: Address of this legal representative: \u2610 known \u2014 \u2610 assumed Street and number: Details of address: Postcode and town: Country: B. Other relevant information concerning the above persons: 5 PURPOSE OF THE NOTIFICATION: see the attached uniform notification form. 6 DESCRIPTION OF THE NOTIFIED DOCUMENT(S): see the attached uniform notification form. 7. FOLLOW-UP OF THE REQUEST FOR NOTIFICATION Date Nr Message Applicant authority Requested authority date 1 \u2610 I, requested authority, acknowledge receipt of the request. date 2 \u2610 I, requested authority, invite the applicant authority to complete the request with the following additional information: date 3 \u2610 I, requested authority, have not yet received the additional information required and will close your request if I do not receive this information before 20YY/MM/DD. date 4 I, applicant authority, \u2610 a provide on request the following additional information: \u2610 b I am not able to provide the requested additional information (because: ) date 5 \u2610 I, requested authority, acknowledge receipt of the additional information and am now in a position to proceed. date 6 \u2610 \u2610 \u2610 \u2610 \u2610 I, requested authority, do not provide assistance and close the case because: a I do not have competence for any of the taxes to which the request relates. b the claim(s) is/are older than foreseen in the Protocol. c the amount of the claim(s) is below the threshold. d the applicant authority did not provide all the required additional information e Other reason: date 7 \u2610 I, applicant authority, ask to be informed about the present status of my request. date 8 I, requested authority, certify: \u2610 a that the document(s) has (have) been notified to the addressee, with legal effect according to the national legislation of the State of the requested authority, on 20YY/MM/DD. The notification was made in the following manner: \u2610 to the addressee in person \u2610 by mail \u2610 by electronic mail \u2610 by registered mail \u2610 by bailiff \u2610 by another procedure \u2610 b that the above-mentioned document(s) could not be notified to the person concerned for the following reasons: \u2610 addressee(s) not known \u2610 addressee(s) deceased \u2610 addressee(s) has (have) left the State. New address: \u2610 other: date 9 \u2610 I, applicant authority, withdraw my request for notification. date 10 \u2610 Other: comment from o applicant authority or o requested authority Model form E \u2013 request for recovery or precautionary measures REQUEST FOR \u2610 RECOVERY MEASURES Based on Article PVAT.25 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom AND/OR \u2610 PRECAUTIONARY MEASURES Based on Article PVAT.31 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom Reference: AA_RA_aaaaaaaaaaa_rrrrrrrrrrrr_20YYMMDD_xxxxxxx_RR(RP) Nature of the claim(s): 1. STATE OF THE APPLICANT AUTHORITY A. Applicant authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills: B. Office initiating the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 2. STATE OF THE REQUESTED AUTHORITY A. Requested authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills: B. Office handling the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 3. INFORMATION ABOUT THE REQUEST \u2610 The claim(s) is (are) the subject of an instrument permitting enforcement in the applicant State. \u2610 The claim(s) is (are) not yet subject of an instrument permitting enforcement in the applicant State. \u2610 The claim(s) is (are) not contested. \u2610 The claim(s) may no longer be contested by an administrative appeal/by an appeal to the courts. \u2610 The claim(s) is (are) contested but the laws, regulations and administrative practices in force in the State of the applicant authority allow recovery of a contested claim. \u2610 The total amount of the claims for which assistance is requested, is not less than GBP 5 000 . \u2610 This request relates to claims that fulfil the age requirement applying under the Protocol. \u2610 This request for precautionary measures is based on the reasons described in the attached document(s). \u2610 This request is accompanied by an instrument permitting precautionary measures in the applicant state. \u2610 I request not to inform the debtor/other person concerned prior to the precautionary measures. \u2610 Please contact me if the following specific situation occurs (by using the free text field at the end of the request form: \u2610 I, applicant authority will reimburse the sums already transferred if the outcome of the contestation is favourable to the party concerned. \u2610 Sensitive case: 4. PAYMENT INSTRUCTIONS A. Please remit the amount of the claim recovered to: \u2014 Bank account number (IBAN): \u2014 Bank identification code (BIC): \u2014 Name of the bank: \u2014 Name of the account holder: \u2014 Address of the account holder: \u2014 Payment reference to be used at the transfer of the money: B. Payment by instalment is: \u2610 acceptable without further consultation \u2610 only acceptable after consultation (Please use box 7, point 20 for this consultation) \u2610 not acceptable 5. INFORMATION ABOUT THE PERSON CONCERNED BY THE REQUEST A Recovery/precautionary measures are requested with regard to: \u2610 For natural persons: First name(s): Surname: Maiden name (name at birth): Date of birth: Place of birth: VAT number: Tax Identification Number: Other identification data: Address of this person/legal entity: \u2610 known \u2014 \u2610 assumed Street and number: Details of address: Postcode and town: \u2610 Or for legal entities: Legal status: Company name: VAT number: Tax Identification Number: Other identification data: Address of this person/legal entity: \u2610 known \u2014 \u2610 assumed Street and number: Details of address: Postcode and town: \u2014 other information concerning this person: \u2014 \u2610 Legal representative \u2014 Name: \u2014 Details of address: \u2610 known \u2014 \u2610 assumed \u2014 Street and number: \u2014 Postcode and town: \u2014 Country: B Other relevant information concerning this request and/or person 1 \u2610 The following person(s) is (are) co-debtor(s): [It should be possible to add more than 1 name of such persons] \u2014 Identity of this person: \u2610 For natural persons: \u2014 Name: \u2014 Date of birth: \u2014 VAT number: \u2014 Tax Identification Number: \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2610 Or for legal entities: \u2014 Legal status: \u2014 Company name: \u2014 VAT number: \u2014 Tax Identification Number: \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2014 other information concerning this (these) co-debtor(s): 2 \u2610 The following person(s) is (are) holding assets belonging to the person concerned by this request: [It should be possible to add more than 1 name of such persons] \u2014 Identity of this person: \u2610 For natural persons: \u2014 Name: \u2014 Date of birth: \u2014 VAT number: \u2014 Tax Identification Number: \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2610 Or for legal entities: \u2014 Legal status: \u2014 Company name: \u2014 VAT number: \u2014 Tax Identification Number: \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2014 assets held by this other person: 3 \u2610 The following person(s) is (are) having debts towards the person concerned by this request: [It should be possible to add more than 1 name of such persons] \u2014 Identity of this person: \u2610 For natural persons: \u2014 Name: \u2014 Date of birth: \u2014 VAT number: \u2014 Tax Identification Number: \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2610 Or for legal entities: \u2014 Legal status: \u2014 Company name: \u2014 VAT number \u2014 Tax Identification Number: \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2014 (future) debts of this other person: 4 \u2610 There (is) are (an)other person(s) than the person concerned by this request, who (is) are liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures under the laws of the applicant State. [It should be possible to add more than 1 name of such persons] \u2014 Identity of this person: \u2610 For natural persons: \u2014 Name: \u2014 Date of birth: \u2014 VAT number: \u2014 Tax Identification Number: \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2610 Or for legal entities: \u2014 Legal status: \u2014 Company name: \u2014 VAT number: \u2014 Tax Identification Number: \u2014 Street and number: \u2014 Details of address: \u2014 Postcode and town: \u2014 Reason or nature of the liability of this other person: 6. DESCRIPTION OF THE CLAIM(S): see the attached uniform instrument permitting enforcement in the requested State. 7. FOLLOW-UP OF THE REQUEST Applicant authority Requested authority date 1 \u2610 I, requested authority, acknowledge receipt of the request. date \u2610 To be combined with acknowledgment 2 \u2610 I, requested authority, invite the applicant authority to complete the request with the following additional information: date 3 \u2610 I, requested authority, have not yet received the additional information required and will close your request if I do not receive this information before 20YY/MM/DD. date 4 I, applicant authority, \u2610 a provide on request the following additional information: \u2610 b am not able to provide the requested additional information (because: ) date 5 \u2610 I, requested authority, acknowledge receipt of the additional information and am now in a position to proceed. date 6 I, requested authority, do not provide assistance and close the case because: \u2610 a I do not have competence for the claims to which your request relates. \u2610 b I do not have competence for the following claim(s) of your request: \u2610 c the claim(s) is/are older than foreseen in the Protocol. \u2610 d the total amount is less than the threshold foreseen in the Protocol. \u2610 e the applicant authority did not provide all the required additional information. \u2610 f Other reason: date 7 \u2610 I, applicant authority, ask to be informed about the present status of my request. date 8 I, requested authority, will not take the requested action(s), for the following reasons: \u2610 a my national legislation and practice does not allow recovery measures for claims that are contested. \u2610 b my national legislation and practice does not allow precautionary measures for claims that are contested. 9 I, requested authority, have conducted the following procedures for recovery and/or precautionary measures: date \u2610 a I established contact with the debtor and requested payment on 20YY/MM/DD. date \u2610 b I am negotiating payment by instalment. date \u2610 c I have commenced enforcement procedures on 20YY/MM/DD. The following actions have been taken: \u2610 d I have commenced precautionary measures on 20YY/MM/DD. The following actions have been taken: \u2610 e I, requested authority, inform the applicant authority that the measures which I have taken (described under point c and/or d above) have the following effect on the period of limitation: \u2610 suspension \u2610 interruption \u2610 prolongation \u2610 till 20YY/MM/DD \u2013 \u2610 with xx years/months/weeks/days I ask the applicant State to inform me if the same effect is not provided for under the laws in force in the applicant State. \u2610 f I, requested authority, inform the applicant authority that suspension, interruption or prolongation of the period of limitation is not possible under the laws of the requested State. I ask the applicant State to confirm whether the measures which I have taken (described under point c and/or d above) have interrupted, suspended or prolonged the time limit for recovery and, if so, what the new time limit is. date 10 \u2610 Procedures are still going on. I, requested authority, will inform applicant authority when changes occur. date 11 \u2610 a I, applicant authority, confirm that: as a result of the action mentioned under point 9, the time limit has been changed. The new time limit is: \u2026 \u2610 b My national laws do not provide for the suspension, interruption or prolongation of the period of limitation. 12 I, requested authority, inform the applicant authority that: date \u2610 a the claim has been fully recovered on 20YY/MM/DD \u2014 of which the following amount (indicate the currency of the State of the requested authority) relates to the claim as mentioned in the request: \u2014 of which the following amount relates to the interest charged under the laws of the State of the requested authority: date \u2610 b the claim has been partly recovered on 20YY/MM/DD, \u2014 for the amount of (indicate the currency of the State of the requested authority): \u2014 of which the following amount relates to the claim as mentioned in the request: \u2014 of which the following amount relates to the interest charged under the laws of the State of the requested authority: \u2610 I will take no further action. \u2610 I will continue recovery procedures. date \u2610 c precautionary measures have been taken. (The requested authority is invited to indicate the nature of these measures:) date \u2610 d the following payment by instalment has been agreed: date 13 I, requested authority, confirm that all or part of the claim could not be recovered/ precautionary measures will not be taken, and the case will be closed because: \u2610 a The person concerned is not known. \u2610 b The person concerned is known, but moved to: \u2610 c The person concerned is known, but moved to an unknown address. \u2610 d The person concerned is deceased on YYYY/MM/DD. \u2610 e Debtor/co-debtor is insolvent. \u2610 f Debtor/co-debtor is bankrupt and the claim has been lodged. Date of order: \u2026 --- Date of release: \u2026 \u2610 g Debtor/co-debtor is bankrupt / no recovery possible \u2610 h Others: date 14 \u2610 I, applicant authority, confirm that the case is closed. date 15 \u2610 I, requested authority, inform the applicant authority that I have received notification that an action has been launched contesting the claim or the instrument permitting its enforcement and will suspend enforcement procedures. Further, \u2610 a I have taken precautionary measures to ensure recovery of the claim on \u2026. \u2610 b I ask the applicant authority to inform me whether I should recover the claim. \u2610 c I inform the applicant authority that the laws, regulations and administrative practices in force in the State in which I am situated do not permit (continued) recovery of the claim as long as it is contested. date 16 I, applicant authority, having been informed that an action has been launched contesting the claim or the instrument permitting its enforcement, \u2610 a ask the requested authority to suspend any action which it has undertaken. \u2610 b ask the requested authority to take precautionary measures to ensure recovery of the claim. \u2610 c ask the requested authority to (continue to) recover the claim. date 17 \u2610 I, requested authority, inform the applicant authority that the laws, regulations and administrative practices in force in the State in which I am situated do not permit the action requested: \u2610 under point 16(b). \u2610 under point 16(c). date 18 I, applicant authority, \u2610 a amend the request for recovery/precautionary measures \u2610 in accordance with the decision about the contested claim, [this information about the decision will be put in box 6A] \u2610 because part of the claim was paid directly to the applicant authority; \u2610 for another reason: \u2026. \u2610 b ask the requested authority to resume enforcement procedures since the contestation was not favourable to the debtor (decision of the body competent in this matter of \u2026). date 19 I, applicant authority, withdraw this request for recovery/precautionary measures because: \u2610 a the amount was paid directly to the applicant authority. \u2610 b the time limit for recovery action has elapsed. \u2610 c the claim(s) has (have) been annulled by a national court or by an administrative body. \u2610 d the instrument permitting enforcement has been annulled. \u2610 e other reason: \u2026 date 20 \u2610 Other: comment from o applicant authority or o requested authority (Please start each comment by indicating the date) (1) In this third column, the requested authority either fills in the information requested by the requesting authority (box \"please fill in\" ticked in the second column) or confirms the veracity of the information provided by the requesting authority (box \"please confirm\" ticked and information provided in the second column). (2) Actual principal activity means the real main activity carried out by the business (as opposed to another possibly declared one). (3) In this third column, the requested authority either fills in the information requested by the requesting authority (box \"please fill in\" ticked in the second column) or confirms the veracity of the information provided by the requesting authority (box \"please confirm\" ticked and information provided in the second column). (4) This is any business with common directors or other legal, economic or financial links with the business referred to in Heading A. (5) To be provided by the competent authority receiving the information. PROTOCOL ON MUTUAL ADMINISTRATIVE ASSISTANCE IN CUSTOMS MATTERS Article PCUST.1 Definitions 1. For the purposes of this Protocol: (a) \"applicant authority\" means a competent administrative authority which has been designated by a Party for this purpose and which makes a request for assistance on the basis of this Protocol; (b) \"operations in breach of customs legislation\" means any violation or attempted violation of customs legislation; (c) \"requested authority\" means a competent administrative authority which has been designated by a Party for this purpose and which receives a request for assistance on the basis of this Protocol. 2. Unless otherwise provided in this Protocol, the definitions of Chapter 5 of Title I of Heading One of Part Two of this Agreement also apply to this Protocol. Article PCUST.2 Scope 1. The Parties shall assist each other in the areas within their competence, in the manner and under the conditions laid down in this Protocol, to ensure the correct application of customs legislation, in particular by preventing, investigating and combating operations in breach of that legislation. 2. The provisions on assistance in customs matters provided for in this Protocol apply to any administrative authority of either Party which is competent for the application of this Protocol. That assistance shall neither prejudice the provisions governing mutual assistance in criminal matters nor shall it cover information obtained under powers exercised at the request of a judicial authority, except where communication of such information is authorised by that authority. 3. Assistance in the recovery of duties, taxes or fines is covered by the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties. Article PCUST.3 Assistance on request 1. At the request of the applicant authority, the requested authority shall provide the applicant authority with all relevant information which may enable the applicant authority to ensure that customs legislation is correctly applied, including information related to activities noted or planned which are or could be operations in breach of customs legislation. 2. At the request of the applicant authority, the requested authority shall in particular inform it whether: (a) goods exported from the territory of one of the Parties have been properly imported into the territory of the other Party, specifying, where appropriate, the customs procedure applied to the goods; (b) goods imported into the territory of one of the Parties have been properly exported from the territory of the other Party, specifying, where appropriate, the customs procedure applied to the goods. 3. At the request of the applicant authority, the requested authority shall take the necessary steps in accordance with its applicable laws and regulations to ensure special surveillance of and to provide the applicant authority with information on: (a) natural or legal persons in respect of whom there are reasonable grounds for believing that they are or have been involved in operations in breach of customs legislation; (b) goods that are or may be transported in such a way that there are reasonable grounds for believing that they have been or are intended to be used in operations in breach of customs legislation; (c) places where stocks of goods have been or may be stored or assembled in such a way that there are reasonable grounds for believing that these goods have been or are intended to be used in operations in breach of customs legislation; (d) means of transport that are or may be used in such a way that there are reasonable grounds for believing that they are intended to be used in operations in breach of customs legislation; and (e) premises suspected by the applicant authority of being used to commit breaches of customs legislation. Article PCUST.4 Spontaneous assistance Wherever possible, on their own initiative, the Parties shall assist each other in accordance with their laws and regulations by providing information on concluded, planned or ongoing activities which constitute or appear to constitute operations in breach of customs legislation and which may be of interest to the other Party. The information shall focus in particular on: (a) goods known to be subject to operations in breach of customs legislation; (b) persons in respect of whom there are reasonable grounds for believing they are or have been involved in operations in breach of customs legislation; (c) means of transport in respect of which there are reasonable grounds for believing that they have been, are, or may be used in operations in breach of customs legislation; and (d) new means or methods employed in carrying out operations in breach of customs legislation. Article PCUST.5 Form and substance of requests for assistance 1. Requests pursuant to this Protocol shall be made in writing either in print or electronic format. They shall be accompanied by the documents necessary to enable compliance with the request. In case of urgency, the requested authority may accept oral requests, but such oral requests shall be confirmed by the applicant authority in writing promptly. 2. Requests pursuant to paragraph 1 shall include the following information: (a) the applicant authority and requesting official; (b) the information or type of assistance requested; (c) the object of and the reason for the request; (d) the laws and regulations and other legal elements involved; (e) indications as exact and comprehensive as possible on the goods or persons who are the target of the investigations; (f) a summary of the relevant facts and of the enquiries already carried out; and (g) any additional available details to enable the requested authority to comply with the request. 3. Requests shall be submitted in an official language of the requested authority or in a language acceptable to that authority, English always being an acceptable language. This requirement does not apply to any documents that accompany the request under paragraph 1. 4. If a request does not meet the formal requirements set out in this Article, the requested authority may require the correction or the completion of the request; pending such correction or completion, precautionary measures may be ordered. Article PCUST.6 Execution of requests 1. In order to comply with a request for assistance, the requested authority shall proceed promptly, within the limits of its competence, as though it was acting on its own account or at the request of another authority of that same Party, by supplying information already in its possession, by carrying out appropriate enquiries or by arranging for those enquiries to be carried out. This provision shall also apply to any other authority to which the request has been addressed by the requested authority when the latter cannot act on its own. In providing any such assistance the requested authority shall give appropriate consideration to the urgency of the request. 2. Requests for assistance shall be executed in accordance with the laws and regulations of the requested Party. Article PCUST.7 Form in which information is to be communicated 1. The requested authority shall communicate results of enquiries conducted pursuant to a request made under this Protocol to the applicant authority in writing, together with relevant documents, certified copies of documents or other items. This information may be provided in electronic format. 2. Original documents shall be transmitted according to each Party's legal constraints, only at the request of the applicant authority, in cases where certified copies would be insufficient. The applicant authority shall return those originals at the earliest opportunity. 3. Under the provisions referred to in paragraph 2, the requested authority shall deliver to the applicant authority any information related to the authenticity of the documents issued or certified by official agencies within its territory in support of a goods declaration. Article PCUST.8 Presence of officials of one Party in the territory of another 1. Duly authorised officials of a Party may, with the agreement of the other Party and subject to the conditions laid down by the latter, be present in the offices of the requested authority or any other concerned authority referred to in Article PCUST.6(1) to obtain information relating to activities that are or could be operations in breach of customs legislation which the applicant authority needs for the purposes of this Protocol. 2. With the agreement of the requested Party, and subject to the conditions it may specify, duly authorised officials of the other Party may be present at enquiries carried out in the requested Party's territory. Article PCUST.9 Delivery and notification 1. At the request of the applicant authority, the requested authority shall take all necessary measures in accordance with its applicable laws and regulations in order to deliver any documents or to notify any decisions of the applicant authority that fall within the scope of this Protocol, to an addressee residing or established in the territory of the requested authority. 2. Such requests for the delivery of documents or the notification of decisions shall be made in writing in an official language of the requested authority or in a language acceptable to that authority. Article PCUST.10 Automatic exchange of information 1. The Parties may, by mutual arrangement in accordance with Article PCUST.15 of this Protocol: (a) exchange any information covered by this Protocol on an automatic basis; (b) exchange specific information in advance of the arrival of consignments in the territory of the other Party. 2. The Parties may establish arrangements on the type of information they wish to exchange, the format and the frequency of transmission to implement the exchanges under points (a) and (b) of paragraph 1. Article PCUST.11 Exceptions to the obligation to provide assistance 1. Assistance under this Protocol may be refused or may be subject to the satisfaction of certain conditions or requirements in cases where a Party is of the opinion that such assistance would: (a) be likely to prejudice the sovereignty of the United Kingdom or that of a Member State which has been requested to provide assistance under this Protocol; (b) be likely to prejudice public policy, security or other essential interests; or (c) violate an industrial, commercial or professional secret. 2. The requested authority may postpone the assistance on the grounds that such assistance will interfere with ongoing investigations, prosecutions or proceedings. In such a case, the requested authority shall consult with the applicant authority to determine if assistance can be given subject to such terms or conditions as the requested authority may require. 3. Where the applicant authority seeks assistance which it would itself be unable to provide if so requested, it shall draw attention to that fact in its request. It shall then be for the requested authority to decide how to respond to such a request. 4. In the cases referred to in paragraphs 1 and 2, the requested authority shall communicate its decision and the reasons for that decision to the applicant authority without delay. Article PCUST.12 Information exchange and confidentiality 1. The information received under this Protocol shall be used solely for the purposes established in this Protocol. 2. The use of information obtained under this Protocol in administrative or judicial proceedings instituted in respect of operations in breach of customs legislation is considered to be for the purposes of this Protocol. Therefore, the Parties may use information obtained and documents consulted in accordance with the provisions of this Protocol as evidence in their records of evidence, reports and testimonies and in proceedings and charges brought before the courts or tribunals. The requested authority may subject the supply of information or the granting of access to documents to the condition that it is notified of such use. 3. Where one of the Parties wishes to use such information for other purposes, it shall obtain the prior written consent of the authority which provided the information. Such use shall then be subject to any restrictions laid down by that authority. 4. Any information communicated in whatsoever form pursuant to this Protocol shall be considered to be of a confidential or restricted nature, in accordance with the laws and regulations applicable in each Party. That information shall be covered by the obligation of professional secrecy and shall enjoy the protection granted to similar information under the relevant laws and regulations of the receiving Party, unless the Party which provided the information gives its prior consent to the disclosure of such information. The Parties shall communicate to each other information on their applicable laws and regulations. Article PCUST.13 Experts and witnesses The requested authority may authorise its officials to appear, within the limitations of the authorisation granted, as experts or witnesses in judicial or administrative proceedings regarding the matters covered by this Protocol, and produce such objects, documents or confidential or certified copies thereof, as may be needed for the proceedings. The request for appearance must indicate specifically before which judicial or administrative authority the official will have to appear, on what matters and by virtue of what title or qualification the official will be questioned. Article PCUST.14 Assistance expenses 1. Subject to paragraphs 2 and 3, the Parties shall waive any claims on each other for reimbursements of expenses incurred in the execution of this Protocol. 2. Expenses and allowances paid to experts, witnesses, interpreters and translators, other than public service employees, shall be borne as appropriate by the requesting Party. 3. If expenses of a substantial or extraordinary nature are or will be required to execute the request, the Parties shall consult to determine the terms and conditions under which the request is to be executed, as well as the manner in which the costs are to be borne. Article PCUST.15 Implementation 1. The implementation of this Protocol shall be entrusted on the one hand to the customs authorities of the United Kingdom and on the other hand to the competent services of the European Commission and the customs authorities of the Member States of the Union, as appropriate. They shall decide on all practical measures and arrangements necessary for the implementation of this Protocol, taking into consideration their respective applicable laws and regulations, in particular for the protection of personal data. 2. Each Party shall keep the other Party informed of the detailed implementation measures which it adopts in accordance with the provisions of this Protocol, in particular with respect to the duly authorised services and officials designated as competent to send and receive the communications provided for in this Protocol. 3. In the Union, the provisions of this Protocol shall not affect the communication of any information obtained under this Protocol between the competent services of the European Commission and the customs authorities of the Member States. Article PCUST.16 Other agreements The provisions of this Protocol shall take precedence over the provisions of any bilateral agreement on mutual administrative assistance in customs matters which has been or may be concluded between individual Member States of the Union and the United Kingdom insofar as the provisions of those bilateral agreements are incompatible with those of this Protocol. Article PCUST.17 Consultations In respect of the interpretation and implementation of this Protocol, the Parties shall consult each other to resolve the matter in the framework of the Trade Specialised Committee on Customs Cooperation and Rules of Origin. Article PCUST.18 Future developments With a view to supplementing the levels of mutual assistance provided for in this Protocol, the Trade Specialised Committee on customs cooperation and rules of origin may adopt a decision to expand this Protocol by establishing arrangements on specific sectors or matters in accordance with the Parties' respective customs legislation. PROTOCOL ON SOCIAL SECURITY COORDINATION TITLE I GENERAL PROVISIONS Article SSC.1 Definitions For the purposes of this Protocol, the following definitions apply: (a) \"activity as an employed person\" means any activity or equivalent situation treated as such for the purposes of the social security legislation of the State in which such activity or equivalent situation exists; (b) \"activity as a self-employed person\" means any activity or equivalent situation treated as such for the purposes of the social security legislation of the State in which such activity or equivalent situation exists; (c) \"assisted reproduction services\" means any medical, surgical or obstetric services provided for the purpose of assisting a person to carry a child; (d) \"benefits in kind\" means: (i) for the purposes of Chapter 1 of Title III, benefits in kind provided for under the legislation of a State which are intended to supply, make available, pay directly or reimburse the cost of medical care and products and services ancillary to that care; (ii) for the purposes of Chapter 2 of Title III, all benefits in kind relating to accidents at work and occupational diseases as defined in point (i) and provided for under the States' accidents at work and occupational diseases schemes; (e) \"child-raising period\" refers to any period which is credited under the pension legislation of a State or which provides a supplement to a pension explicitly for the reason that a person has raised a child, irrespective of the method used to calculate those periods and whether they accrue during the time of child-raising or are acknowledged retroactively; (f) \"civil servant\" means a person considered to be such or treated as such by the State to which the administration employing them is subject; (g) \"competent authority\" means, in respect of each State, the Minister, Ministers or other equivalent authority responsible for social security schemes throughout or in any part of the State in question; (h) \"competent institution\" means: (i) the institution with which the person concerned is insured at the time of the application for benefit; or (ii) the institution from which the person concerned is or would be entitled to benefits if that person or a member or members of their family resided in the State in which the institution is situated; or (iii) the institution designated by the competent authority of the State concerned; or (iv) in the case of a scheme relating to an employer's obligations in respect of the benefits set out in Article SSC.3(1), either the employer or the insurer involved or, in default thereof, the body or authority designated by the competent authority of the State concerned; (i) \"competent State\" means the State in which the competent institution is situated; (j) \"death grant\" means any one-off payment in the event of death, excluding the lump-sum benefits referred to in point (w); (k) \"family benefit\" means all benefits in kind or in cash intended to meet family expenses; (l) \"frontier worker\" means any person pursuing an activity as an employed or self-employed person in a State and who resides in another State to which that person returns as a rule daily or at least once a week; (m) \"home base\" means the place from where the crew member normally starts and ends a duty period or a series of duty periods, and where, under normal conditions, the operator/airline is not responsible for the accommodation of the crew member concerned; (n) \"institution\" means, in respect of each State, the body or authority responsible for applying all or part of the legislation; (o) \"institution of the place of residence\" and \"institution of the place of stay\" mean, respectively, the institution which is competent to provide benefits in the place where the person concerned resides and the institution which is competent to provide benefits in the place where the person concerned is staying, in accordance with the legislation administered by that institution or, where no such institution exists, the institution designated by the competent authority of the State concerned; (p) \"insured person\", in relation to the social security branches covered by Chapters 1 and 3 of Title III, means any person satisfying the conditions required under the legislation of the State competent under Title II in order to have the right to benefits, taking into account the provisions of this Protocol; (q) \"legislation\" means, in respect of each State, laws, regulations and other statutory provisions and all other implementing measures relating to the social security branches covered by Article SSC.3(1), but excludes contractual provisions other than those which serve to implement an insurance obligation arising from the laws and regulations referred to in this point or which have been the subject of a decision by the public authorities which makes them obligatory or extends their scope, provided that the State concerned makes a declaration to that effect, notified to the Specialised Committee on Social Security Coordination. The European Union shall publish such a declaration in the Official Journal of the European Union; (r) \"long-term care benefit\" means a benefit in kind or in cash the purpose of which is to address the care needs of a person who, on account of impairment, requires considerable assistance, including but not limited to assistance from another person or persons to carry out essential activities of daily living for an extended period of time in order to support their personal autonomy; this includes benefits granted for the same purpose to a person providing such assistance; (s) \"member of the family\" means: (i) (A) any person defined or recognised as a member of the family or designated as a member of the household by the legislation under which benefits are provided; (B) with regard to benefits in kind pursuant to Chapter 1 of Title III, any person defined or recognised as a member of the family or designated as a member of the household by the legislation of the State in which that person resides; (ii) if the legislation of a State which is applicable under point (i) does not make a distinction between the members of the family and other persons to whom it is applicable, the spouse, minor children, and dependent children who have reached the age of majority shall be considered members of the family; (iii) if, under the legislation which is applicable under points (i) and (ii), a person is considered a member of the family or member of the household only if that person lives in the same household as the insured person or pensioner, this condition shall be considered satisfied if the person in question is mainly dependent on the insured person or pensioner; (t) \"period of employment\" or \"period of self-employment\" mean periods so defined or recognised by the legislation under which they were completed, and all periods treated as such, where they are regarded by that legislation as equivalent to periods of employment or to periods of self-employment; (u) \"period of insurance\" means periods of contribution, employment or self-employment as defined or recognised as periods of insurance by the legislation under which they were completed or considered as completed, and all periods treated as such, where they are regarded by that legislation as equivalent to periods of insurance; (v) \"period of residence\" means periods so defined or recognised by the legislation under which they were completed or considered as completed; (w) \"pension\" covers not only pensions but also lump-sum benefits which can be substituted for them and payments in the form of reimbursement of contributions and, subject to the provisions of Title III, revaluation increases or supplementary allowances; (x) \"pre-retirement benefit\" means all cash benefits, other than an unemployment benefit or an early old-age benefit, provided from a specified age to workers who have reduced, ceased or suspended their remunerative activities until the age at which they qualify for an old-age pension or an early retirement pension, the receipt of which is not conditional upon the person concerned being available to the employment services of the competent State; \"early old-age benefit\" means a benefit provided before the normal pension entitlement age is reached and which either continues to be provided once the said age is reached or is replaced by another old-age benefit; (y) \"refugee\" has the meaning assigned to it in Article 1 of the Convention relating to the Status of Refugees, signed in Geneva on 28 July 1951; (z) \"registered office or place of business\" means the registered office or place of business where the essential decisions of the undertaking are adopted and where the functions of its central administration are carried out; (aa) \"residence\" means the place where a person habitually resides; (bb) \"special non-contributory cash benefits\" means those non-contributory cash benefits which: (i) are intended to provide either: (A) supplementary, substitute or ancillary cover against the risks covered by the branches of social security referred to in Article SSC.3(1), and which guarantee the persons concerned a minimum subsistence income having regard to the economic and social situation in the State concerned; or (B) solely specific protection for the disabled, closely linked to the said person's social environment in the State concerned, and (ii) where the financing exclusively derives from compulsory taxation intended to cover general public expenditure and the conditions for providing and for calculating the benefits are not dependent on any contribution in respect of the beneficiary. However, benefits provided to supplement a contributory benefit shall not be considered to be contributory benefits for this reason alone; (cc) \"special scheme for civil servants\" means any social security scheme which is different from the general social security scheme applicable to employed persons in the State concerned and to which all, or certain categories of, civil servants are directly subject; (dd) \" stateless person\" has the meaning assigned to it in Article 1 of the Convention relating to the Status of Stateless Persons, signed in New York on 28 September 1954; (ee) \"stay\" means temporary residence. Article SSC.2 Persons covered This Protocol applies to persons, including stateless persons and refugees, who are or have been subject to the legislation of one or more States, as well as to the members of their families and their survivors. Article SSC.3 Matters covered 1. This Protocol applies to the following branches of social security: (a) sickness benefits; (b) maternity and equivalent paternity benefits; (c) invalidity benefits; (d) old-age benefits; (e) survivors' benefits; (f) benefits in respect of accidents at work and occupational diseases; (g) death grants; (h) unemployment benefits; (i) pre-retirement benefits. 2. Unless otherwise provided for in Annex SSC-6, this Protocol applies to general and special social security schemes, whether contributory or non-contributory, and to schemes relating to the obligations of an employer or ship-owner. 3. The provisions of Title III do not, however, affect the legislative provisions of any State concerning a ship-owner's obligations. 4. This Protocol does not apply to: (a) special non-contributory cash benefits which are listed in Part 1 of Annex SSC-1; (b) social and medical assistance; (c) benefits in relation to which a State assumes the liability for damages to persons and provides for compensation, such as those for victims of war and military action or their consequences; victims of crime, assassination or terrorist acts; victims of damage occasioned by agents of the State in the course of their duties; or victims who have suffered a disadvantage for political or religious reasons or for reasons of descent; (d) long-term care benefits which are listed in Part 2 of Annex SSC-1; (e) assisted reproduction services; (f) payments which are connected to a branch of social security listed in paragraph 1 and which are: (i) paid to meet expenses for heating in cold weather; and (ii) listed in Part 3 of Annex SSC-1; (g) family benefits. Article SSC.4 Non-discrimination between Member States 1. Social security coordination arrangements established in this Protocol shall be based on the principle of non-discrimination between the Member States. 2. This Article is without prejudice to any arrangements made between the United Kingdom and Ireland concerning the Common Travel Area. Article SSC.5 Equality of treatment 1. Unless otherwise provided for in this Protocol, as regards the branches of social security covered by Article SSC.3(1), persons to whom this Protocol applies shall enjoy the same benefits and be subject to the same obligations under the legislation of any State as the nationals thereof. 2. This provision does not apply to the matters referred to in Article SSC.3(4). Article SSC.6 Equal treatment of benefits, income, facts or events Unless otherwise provided for in this Protocol, the States shall ensure the application of the principle of equal treatment of benefits, income, facts or events in the following manner: (a) where, under the legislation of the competent State, the receipt of social security benefits and other income has certain legal effects, the relevant provisions of that legislation shall also apply to the receipt of equivalent benefits acquired under the legislation of another State or to income acquired in another State; (b) where, under the legislation of the competent State, legal effects are attributed to the occurrence of certain facts or events, that State shall take account of like facts or events that have occurred in any other State as though they had taken place in its own territory. Article SSC.7 Aggregation of periods Unless otherwise provided for in this Protocol, the competent institution of a State shall, to the extent necessary, take into account periods of insurance, employment, self-employment or residence completed under the legislation of any other State as though they were periods completed under the legislation which it applies, where its legislation makes conditional upon the completion of periods of insurance, employment, self-employment or residence: (a) the acquisition, retention, duration or recovery of the right to benefits; (b) the coverage by legislation; or (c) the access to or the exemption from compulsory, optional continued or voluntary insurance. Article SSC.8 Waiving of residence rules The States shall ensure the application of the principle of exportability of cash benefits in accordance with points (a) and (b): (a) Cash benefits payable under the legislation of a State or under this Protocol shall not be subject to any reduction, amendment, suspension, withdrawal or confiscation on account of the fact that the beneficiary or the members of their family reside in a State other than that in which the institution responsible for providing benefits is situated. (b) Point (a) does not apply to the cash benefits covered by points (c) and (h) of Article SSC.3(1). Article SSC.9 Preventing of overlapping of benefits Unless otherwise provided, this Protocol shall neither confer nor maintain the right to several benefits of the same kind for one and the same period of compulsory insurance. TITLE II DETERMINATION OF THE LEGISLATION APPLICABLE Article SSC.10 General rules 1. Persons to whom this Protocol applies shall be subject to the legislation of a single State only. Such legislation shall be determined in accordance with this Title. 2. For the purposes of this Title, persons receiving cash benefits because or as a consequence of their activity as an employed or self-employed person shall be considered to be pursuing the said activity. This shall not apply to invalidity, old-age or survivors' pensions or to pensions in respect of accidents at work or occupational diseases or to sickness benefits in cash covering treatment for an unlimited period. 3. Subject to Articles SSC.11, SSC.12 and SSC.13: (a) a person pursuing an activity as an employed or self-employed person in a State shall be subject to the legislation of that State; (b) a civil servant shall be subject to the legislation of the State to which the administration employing them is subject; (c) any other person to whom points (a) and (b) do not apply shall be subject to the legislation of the State of residence, without prejudice to other provisions of this Protocol guaranteeing them benefits under the legislation of one or more other States. 4. For the purposes of this Title, an activity as an employed or self-employed person normally pursued on board a vessel at sea flying the flag of a State shall be deemed to be an activity pursued in the said State. However, a person employed on board a vessel flying the flag of a State and remunerated for such activity by an undertaking or a person whose registered office or place of business is in another State shall be subject to the legislation of the latter State if that person resides in that State. The undertaking or person paying the remuneration shall be considered as the employer for the purposes of the said legislation. 5. An activity as a flight crew or cabin crew member performing air passenger or freight services shall be deemed to be an activity pursued in the State where the home base is located. Article SSC.11 Detached workers 1. By way of derogation from Article SSC.10(3) and as a transitional measure in relation to the situation that existed before the entry into force of this Agreement, the following rules as regards the applicable legislation apply between the Member States listed in Category A of Annex SSC-8 and the United Kingdom: (a) a person who pursues an activity as an employed person in a State for an employer which normally carries out its activities there and who is sent by that employer to another State to perform work on that employer's behalf shall continue to be subject to the legislation of the first State, provided that: (i) the duration of such work does not exceed 24 months; and (ii) that person is not sent to replace another detached worker. (b) a person who normally pursues an activity as a self-employed person in a State who goes to pursue a similar activity in another State shall continue to be subject to the legislation of the first State, provided that the anticipated duration of such activity does not exceed 24 months. 2. By the date of entry into force of this Agreement, the Union shall notify the United Kingdom which of the following categories each Member State falls under: (a) Category A: The Member State has notified the Union that it wishes to derogate from Article SSC.10 in accordance with this Article; (b) Category B: The Member State has notified the Union that it does not wish to derogate from Article SSC.10; or (c) Category C: The Member State has not indicated whether it wishes to derogate from Article SSC.10. 3. The document referred to in paragraph 2 shall become the content of Annex SSC-8 on the date of entry into force of this Agreement. 4. For Member States which are listed in Category A on the date of entry into force of this Agreement, points (a) and (b) of paragraph 1 shall apply. 5. For Member States which are listed in Category C on the date of entry into force of this Agreement, points (a) and (b) of paragraph 1 shall apply as though that Member State was listed in Category A for one month after the date of entry into force of this Agreement. The Specialised Committee on Social Security Coordination shall move a Member State from Category C to Category A if the Union notifies the Specialised Committee on Social Security Coordination that that Member State wishes to be so moved. 6. A month after the date of entry into force of this Agreement, Categories B and C will cease to exist. The Parties shall publish an updated Annex SSC-8 as soon as possible thereafter. For the purpose of paragraph 1, Annex SSC-8 will be considered as containing only Category A Member States as from the date of that publication. 7. Where a person is in a situation referred to in paragraph 1 involving a Category C Member State before the publication of an updated Annex SSC-8 in accordance with paragraph 6, paragraph 1 shall continue to apply to that person for the duration of their activities under paragraph 1. 8. The Union shall notify the Specialised Committee on Social Security Coordination if a Member State wishes to be removed from Category A of Annex SSC-8 and the Specialised Committee on Social Security Coordination shall, at the request of the Union, remove that Member State from Category A of Annex SSC-8. The Parties shall publish an updated Annex SSC-8 which shall apply as from the first day of the second month following the receipt of the request by the Specialised Committee on Social Security Coordination. 9. Where a person is in a situation referred to in paragraph 1 before the publication of an updated Annex SSC-8 in accordance with paragraph 8, paragraph 1 shall continue to apply to that person for the duration of that person's activities under paragraph 1. Article SSC.12 Pursuit of activities in two or more States 1. A person who normally pursues an activity as an employed person in one or more Member States as well as in the United Kingdom shall be subject to: (a) the legislation of the State of residence if that person pursues a substantial part of their activity in that State; or (b) if that person does not pursue a substantial part of their activity in the State of residence: (i) the legislation of the State in which the registered office or place of business of the undertaking or employer is situated if that person is employed by one undertaking or employer; or (ii) the legislation of the State in which the registered office or place of business of the undertakings or employers is situated if that person is employed by two or more undertakings or employers which have their registered office or place of business in only one State; or (iii) the legislation of the State in which the registered office or place of business of the undertaking or employer is situated other than the State of residence if that person is employed by two or more undertakings or employers, which have their registered office or place of business in a Member State and the United Kingdom, one of which is the State of residence; or (iv) the legislation of the State of residence if that person is employed by two or more undertakings or employers, at least two of which have their registered office or place of business in different States other than the State of residence. 2. A person who normally pursues an activity as a self-employed person in one or more Member States as well as in the United Kingdom shall be subject to: (a) the legislation of the State of residence if that person pursues a substantial part of their activity in that State; or (b) the legislation of the State in which the centre of interest of their activities is situated, if that person does not reside in one of the States in which that person pursues a substantial part of their activity. 3. A person who normally pursues an activity as an employed person and an activity as a self-employed person in two or more States shall be subject to the legislation of the State in which that person pursues an activity as an employed person or, if that person pursues such an activity in two or more States, to the legislation determined in accordance with paragraph 1. 4. A person who is employed as a civil servant by a State and who pursues an activity as an employed person or as a self-employed person in one or more other States shall be subject to the legislation of the State to which the administration employing that person is subject. 5. A person who normally pursues an activity as an employed person in two or more Member States (and not in the United Kingdom) shall be subject to the legislation of the United Kingdom if that person does not pursue a substantial part of that activity in the State of residence and that person: (a) is employed by one or more undertakings or employers, all of which have their registered office or place of business in the United Kingdom; (b) resides in a Member State and is employed by two or more undertakings or employers, all of which have their registered office or place of business in the United Kingdom and the Member State of residence; (c) resides in the United Kingdom and is employed by two or more undertakings or employers, at least two of which have their registered office or place of business in different Member States; or (d) resides in the United Kingdom and is employed by one or more undertakings or employers, none of which have a registered office or place of business in another State. 6. A person who normally pursues an activity as a self-employed person in two or more Member States (and not in the United Kingdom), without pursuing a substantial part of that activity in the State of residence, shall be subject to the legislation of the United Kingdom if the centre of interest of their activity is situated in the United Kingdom. 7. Paragraph 6 shall not apply in the case of a person who normally pursues an activity as an employed person and as a self-employed person in two or more Member States. 8. Persons referred to in paragraphs 1 to 6 shall be treated, for the purposes of the legislation determined in accordance with these provisions, as though they were pursuing all their activities as employed or self-employed persons and were receiving all their income in the State concerned. Article SSC.13 Voluntary insurance or optional continued insurance 1. Articles SSC.10, SSC.11 and SSC.12 do not apply to voluntary insurance or to optional continued insurance unless, in respect of one of the branches referred to in Article SSC.3, only a voluntary scheme of insurance exists in a State. 2. Where, by virtue of the legislation of a State, the person concerned is subject to compulsory insurance in that State, that person may not be subject to a voluntary insurance scheme or an optional continued insurance scheme in another State. In all other cases in which, for a given branch, there is a choice between several voluntary insurance schemes or optional continued insurance schemes, the person concerned shall join only the scheme of their choice. 3. However, in respect of invalidity, old-age and survivors' benefits, the person concerned may join the voluntary or optional continued insurance scheme of a State, even if that person is compulsorily subject to the legislation of another State, provided that that person has been subject, at some stage in his or her career, to the legislation of the first State because or as a consequence of an activity as an employed or self-employed person and if such overlapping is explicitly or implicitly allowed under the legislation of the first State. 4. Where the legislation of a State makes admission to voluntary insurance or optional continued insurance conditional upon residence in that State or upon previous activity as an employed or self-employed person, point (b) of Article SSC.6 shall apply only to persons who have been subject, at some earlier stage, to the legislation of that State on the basis of an activity as an employed or self-employed person. Article SSC.14 Obligations of the employer 1. An employer who has its registered office or place of business outside the competent State shall fulfil all the obligations laid down by the legislation applicable to its employees, notably the obligation to pay the contributions provided for by that legislation, as if it had its registered office or place of business in the competent State. 2. An employer who does not have a place of business in the State whose legislation is applicable and the employee may agree that the latter may fulfil the employer's obligations on its behalf as regards the payment of contributions without prejudice to the employer's underlying obligations. The employer shall send notice of such an arrangement to the competent institution of that State. TITLE III SPECIAL PROVISIONS CONCERNING THE VARIOUS CATEGORIES OF BENEFITS CHAPTER 1 SICKNESS, MATERNITY AND EQUIVALENT PATERNITY BENEFITS SECTION 1 INSURED PERSONS AND MEMBERS OF THEIR FAMILIES EXCEPT PENSIONERS AND MEMBERS OF THEIR FAMILIES Article SSC.15 Residence in a State other than the competent State An insured person or members of their family who reside in a State other than the competent State shall receive in the State of residence benefits in kind provided, on behalf of the competent institution, by the institution of the place of residence, in accordance with the legislation it applies, as though the persons concerned were insured under the said legislation. Article SSC.16 Stay in the competent State when residence is in another State \u2013 special rules for the members of the families of frontier workers 1. Unless otherwise provided for by paragraph 2, the insured person and the members of their family referred to in Article SSC.15 shall also be entitled to benefits in kind while staying in the competent State. The benefits in kind shall be provided by the competent institution and at its own expense, in accordance with the legislation it applies, as though the persons concerned resided in that State. 2. The members of the family of a frontier worker shall be entitled to benefits in kind during their stay in the competent State. Where the competent State is listed in Annex SSC-2 however, the members of the family of a frontier worker who reside in the same State as the frontier worker shall be entitled to benefits in kind in the competent State only under the conditions laid down in Article SSC.17(1). Article SSC.17 Stay outside the competent State 1. Unless otherwise provided for by paragraph 2, an insured person and the members of their family staying in a State other than the competent State shall be entitled to benefits in kind, provided on behalf of the competent institution by the institution of the place of stay in accordance with the legislation it applies, as though the persons concerned were insured under that legislation, where: (a) the benefits in kind become necessary on medical grounds during their stay, in the opinion of the provider of the benefits in kind, taking into account the nature of the benefits and the expected length of the stay; (b) the person did not travel to that State with the purpose of receiving the benefits in kind, unless the person is a passenger or member of the crew on a vessel or aircraft travelling to that State and the benefits in kind became necessary on medical grounds during the voyage or flight; and (c) a valid entitlement document is presented in accordance with Article SSCI.22(1) of Annex SSC-7. 2. Appendix SSCI-2 to Annex SSC-7 lists benefits in kind which, in order to be provided during a stay in another State, require for practical reasons a prior agreement between the person concerned and the institution providing the care. Article SSC.18 Travel with the purpose of receiving benefits in kind \u2013 authorisation to receive appropriate treatment outside the State of residence 1. Unless otherwise provided for in this Protocol, an insured person travelling to another State with the purpose of receiving benefits in kind during the stay shall seek authorisation from the competent institution. 2. An insured person who is authorised by the competent institution to go to another State with the purpose of receiving the treatment appropriate to their condition shall receive the benefits in kind provided, on behalf of the competent institution, by the institution of the place of stay, in accordance with the legislation it applies, as though that person were insured under the said legislation. The authorisation shall be accorded where the treatment in question is among the benefits provided for by the legislation in the State where the person concerned resides and where that person cannot be given such treatment within a time limit which is medically justifiable, taking into account their current state of health and the probable course of their illness. 3. Paragraphs 1 and 2 apply mutatis mutandis to the members of the family of an insured person. 4. If the members of the family of an insured person reside in a State other than the State in which the insured person resides, and this State has opted for reimbursement on the basis of fixed amounts, the cost of the benefits in kind referred to in paragraph 2 shall be borne by the institution of the place of residence of the members of the family. In this case, for the purposes of paragraph 1, the institution of the place of residence of the members of the family shall be considered to be the competent institution. Article SSC.19 Cash benefits 1. An insured person and members of their family residing or staying in a State other than the competent State shall be entitled to cash benefits provided by the competent institution in accordance with the legislation it applies. By agreement between the competent institution and the institution of the place of residence or stay, such benefits may, however, be provided by the institution of the place of residence or stay at the expense of the competent institution in accordance with the legislation of the competent State. 2. The competent institution of a State whose legislation stipulates that the calculation of cash benefits shall be based on average income or on an average contribution basis shall determine such average income or average contribution basis exclusively by reference to the incomes confirmed as having been paid, or contribution bases applied, during the periods completed under the said legislation. 3. The competent institution of a State whose legislation provides that the calculation of cash benefits shall be based on standard income shall take into account exclusively the standard income or, where appropriate, the average of standard incomes for the periods completed under the said legislation. 4. Paragraphs 2 and 3 apply mutatis mutandis to cases where the legislation applied by the competent institution lays down a specific reference period which corresponds in the case in question either wholly or partly to the periods which the person concerned has completed under the legislation of one or more other States. Article SSC.20 Pension claimants 1. An insured person who, on making a claim for a pension, or during the investigation thereof, ceases to be entitled to benefits in kind under the legislation of the State last competent, shall remain entitled to benefits in kind under the legislation of the State in which that person resides, provided that the pension claimant satisfies the insurance conditions of the legislation of the State referred to in paragraph 2. The right to benefits in kind in the State of residence shall also apply to the members of the family of the pension claimant. 2. The benefits in kind shall be chargeable to the institution of the State which, in the event of a pension being awarded, would become competent under Articles SSC.21, SSC.22 and SSC.23. SECTION 2 SPECIAL PROVISIONS FOR PENSIONERS AND MEMBERS OF THEIR FAMILIES Article SSC.21 Right to benefits in kind under the legislation of the State of residence A person who receives a pension or pensions under the legislation of two or more States, of which one is the State of residence, and who is entitled to benefits in kind under the legislation of that State, shall, with the members of their family, receive such benefits in kind from and at the expense of the institution of the place of residence, as though that person were a pensioner whose pension was payable solely under the legislation of that State. Article SSC.22 No right to benefits in kind under the legislation of the State of residence 1. A person who: (a) resides in a State; (b) receives a pension or pensions under the legislation of one or more States; and (c) is not entitled to benefits in kind under the legislation of the State of residence, shall nevertheless receive such benefits for themselves and the members of their family, insofar as the pensioner would be entitled to them under the legislation of the State competent in respect of their pension or at least one of the States competent, if that person resided in that State. The benefits in kind shall be provided at the expense of the institution referred to in paragraph 2 by the institution of the place of residence, as though the person concerned were entitled to a pension and entitled to benefits in kind under the legislation of that State. 2. In the cases covered by paragraph 1, the cost of the benefits in kind shall be borne by the institution as determined in accordance with the following rules: (a) where the pensioner is treated as if he or she were entitled to benefits in kind under the legislation of one State, the cost of those benefits shall be borne by the competent institution of that State; (b) where the pensioner is treated as if he or she were entitled to benefits in kind under the legislation of two or more States, the cost of those benefits shall be borne by the competent institution of the State to whose legislation the person has been subject for the longest period of time; (c) if the application of the rule in point (b) would result in several institutions being responsible for the cost of those benefits, the cost shall be borne by the competent institution of the State to whose legislation the pensioner was last subject. Article SSC.23 Pensions under the legislation of one or more States other than the State of residence, where there is a right to benefits in kind in the latter State Where a person receiving a pension or pensions under the legislation of one or more States resides in a State under whose legislation the right to receive benefits in kind is not subject to conditions of insurance, or conditions of activity as an employed or self-employed person, and that person does not receive a pension from the State of residence, the cost of benefits in kind provided to them and to members of their family shall be borne by the institution of one of the States competent in respect of the person's pensions determined in accordance with Article SSC.22(2), to the extent that the person and the members of their family would be entitled to such benefits if they resided in that State. Article SSC.24 Residence of members of the family in a State other than the one in which the pensioner resides Where a person: (a) receives a pension or pensions under the legislation of one or more States; and (b) resides in a State other than the one in which members of his or her family reside, those members of that person's family shall be entitled to receive benefits in kind from the institution of the place of their residence in accordance with the legislation it applies insofar as the pensioner is entitled to benefits in kind under the legislation of a State. The costs shall be borne by the competent institution responsible for the costs of the benefits in kind provided to the pensioner in their State of residence. Article SSC.25 Stay of the pensioner or the members of their family in a State other than the State of residence \u2013 stay in the competent State \u2013 authorisation for appropriate treatment outside the State of residence 1. Article SSC.17 applies mutatis mutandis to: (a) a person receiving a pension or pensions under the legislation of one or more States and who is entitled to benefits in kind under the legislation of one of the States which provide their pension(s); (b) the members of their family, who are staying in a State other than the one in which they reside. 2. Article SSC.16(1) applies mutatis mutandis to the persons described in paragraph 1 when they stay in the State in which is situated the competent institution responsible for the cost of the benefits in kind provided to the pensioner in his or her State of residence and that State has opted for this and is listed in Annex SSC-3. 3. Article SSC.18 applies mutatis mutandis to a pensioner or members of his or her family who are staying in a State other than the one in which they reside with the purpose of receiving in that State the treatment appropriate to their condition. 4. Unless otherwise provided for by paragraph 5, the cost of the benefits in kind referred to in paragraphs 1 to 3 shall be borne by the competent institution responsible for the cost of benefits in kind provided to the pensioner in their State of residence. 5. The cost of the benefits in kind referred to in paragraph 3 shall be borne by the institution of the place of residence of the pensioner or of the members of their family, if these persons reside in a State which has opted for reimbursement on the basis of fixed amounts. In these cases, for the purposes of paragraph 3, the institution of the place of residence of the pensioner or of the members of their family shall be considered to be the competent institution. Article SSC.26 Cash benefits for pensioners 1. Cash benefits shall be paid to a person receiving a pension or pensions under the legislation of one or more States by the competent institution of the State in which is situated the competent institution responsible for the cost of benefits in kind provided to the pensioner in their State of residence. Article SSC.19 applies mutatis mutandis. 2. Paragraph 1 also applies to the members of a pensioner's family. Article SSC.27 Contributions by pensioners 1. The institution of a State which is responsible under the legislation it applies for making deductions in respect of contributions for sickness, maternity and equivalent paternity benefits, may request and recover such deductions, calculated in accordance with the legislation it applies, only to the extent that the cost of the benefits pursuant to Articles SSC.21 to SSC.24 is to be borne by an institution of that State. 2. Where, in the cases referred to in Article SSC.23, the acquisition of sickness, maternity and equivalent paternity benefits is subject to the payment of contributions or similar payments under the legislation of a State in which the pensioner concerned resides, these contributions shall not be payable by virtue of such residence. SECTION 3 COMMON PROVISIONS Article SSC.28 General provisions Articles SSC.21 to SSC.27 do not apply to a pensioner or the members of the pensioner's family who are entitled to benefits under the legislation of a State on the basis of an activity as an employed or self-employed person. In such cases, the person concerned shall be subject, for the purposes of this Chapter, to Articles SSC.15 to SSC.19. Article SSC.29 Prioritising of the right to benefits in kind \u2013 special rule for the right of members of the family to benefits in the State of residence 1. Unless otherwise provided for by paragraphs 2 and 3, where a member of the family has an independent right to benefits in kind based on the legislation of a State or on this Chapter such right shall take priority over a derivative right to benefits in kind for members of the family. 2. Unless otherwise provided for by paragraph 3, where the independent right in the State of residence exists directly and solely on the basis of the residence of the person concerned in that State, a derivative right to benefits in kind shall take priority over the independent right. 3. Notwithstanding paragraphs 1 and 2, benefits in kind shall be provided to the members of the family of an insured person at the expense of the competent institution in the State in which they reside, where: (a) those members of the family reside in a State under whose legislation the right to benefits in kind is not subject to conditions of insurance or activity as an employed or self-employed person; and (b) the spouse or the person caring for the children of the insured person pursues an activity as an employed or self-employed person in that State, or receives a pension from that State on the basis of an activity as an employed or self-employed person. Article SSC.30 Reimbursements between institutions 1. The benefits in kind provided by the institution of a State on behalf of the institution of another State under this Chapter shall give rise to full reimbursement. 2. The reimbursements referred to in paragraph 1 shall be determined and effected in accordance with the arrangements set out in Annex SSC-7, either on production of proof of actual expenditure, or on the basis of fixed amounts for States whose legal or administrative structures are such that the use of reimbursement on the basis of actual expenditure is not appropriate. 3. The States, and their competent authorities, may provide for other methods of reimbursement or waive all reimbursement between the institutions coming under their jurisdiction. CHAPTER 2 BENEFITS IN RESPECT OF ACCIDENTS AT WORK AND OCCUPATIONAL DISEASES Article SSC.31 Right to benefits in kind and in cash 1. Without prejudice to any more favourable provisions in paragraphs 2 and 3 of this Article, Article SSC.15 and Articles SSC.16(1), SSC.17(1) and SSC.18(1) also apply to benefits relating to accidents at work or occupational diseases. 2. A person who has sustained an accident at work or has contracted an occupational disease and who resides or stays in a State other than the competent State shall be entitled to the special benefits in kind of the scheme covering accidents at work and occupational diseases provided, on behalf of the competent institution, by the institution of the place of residence or stay in accordance with the legislation which it applies, as though that person were insured under that legislation. 3. The competent institution may not refuse to grant the authorisation provided for in Article SSC.18(1) to a person who has sustained an accident at work or who has contracted an occupational disease and is entitled to benefits chargeable to that institution, where the treatment appropriate to his or her condition cannot be given in the State in which that person resides within a time limit which is medically justifiable, taking into account that person's current state of health and the probable course of the illness. 4. Article SSC.19 also applies to benefits falling within this Chapter. Article SSC.32 Costs of transport 1. The competent institution of a State whose legislation provides for meeting the costs of transporting a person who has sustained an accident at work or is suffering from an occupational disease, either to their place of residence or to a hospital, shall meet such costs to the corresponding place in the State where the person resides, provided that that institution gives prior authorisation for such transport, duly taking into account the reasons justifying it. Such authorisation shall not be required in the case of a frontier worker. 2. The competent institution of a State whose legislation provides for meeting the costs of transporting the body of a person killed in an accident at work to the place of burial shall, in accordance with the legislation it applies, meet such costs to the corresponding place in the State where the person was residing at the time of the accident. Article SSC.33 Benefits for an occupational disease where the person suffering from such a disease has been exposed to the same risk in several States When a person who has contracted an occupational disease has, under the legislation of two or more States, pursued an activity which by its nature is likely to cause the said disease, the benefits that that person or his or her survivors may claim shall be provided exclusively under the legislation of the last of those States whose conditions are satisfied. Article SSC.34 Aggravation of an occupational disease In the event of aggravation of an occupational disease for which a person suffering from such a disease has received or is receiving benefits under the legislation of a State, the following rules shall apply: (a) if the person concerned, while in receipt of benefits, has not pursued, under the legislation of another State, an activity as an employed or self-employed person likely to cause or aggravate the disease in question, the competent institution of the first State shall bear the cost of the benefits under the provisions of the legislation which it applies, taking into account the aggravation; (b) if the person concerned, while in receipt of benefits, has pursued such an activity under the legislation of another State, the competent institution of the first State shall bear the cost of the benefits under the legislation it applies without taking the aggravation into account. The competent institution of the second State shall grant a supplement to the person concerned, the amount of which shall be equal to the difference between the amount of benefits due after the aggravation and the amount which would have been due prior to the aggravation under the legislation it applies, if the disease in question had occurred under the legislation of that State; (c) the rules concerning reduction, suspension or withdrawal laid down by the legislation of a State shall not be invoked against persons receiving benefits provided by institutions of two States in accordance with point (b). Article SSC.35 Rules for taking into account the special features of certain legislation 1. If there is no insurance against accidents at work or occupational diseases in the State in which the person concerned resides or stays, or if such insurance exists but there is no institution responsible for providing benefits in kind, those benefits shall be provided by the institution of the place of residence or stay responsible for providing benefits in kind in the event of sickness. 2. If there is no insurance against accidents at work or occupational diseases in the competent State, the provisions of this Chapter concerning benefits in kind shall nevertheless be applied to a person who is entitled to those benefits in the event of sickness, maternity or equivalent paternity under the legislation of that State if that person sustains an accident at work or suffers from an occupational disease during a residence or stay in another State. Costs shall be borne by the institution that is competent for the benefits in kind under the legislation of the competent State. 3. Article SSC.6 applies to the competent institution in a State as regards the equivalence of accidents at work and occupational diseases which either have occurred or have been confirmed subsequently under the legislation of another State when assessing the degree of incapacity, the right to benefits or the amount thereof, on condition that: (a) no compensation is due in respect of an accident at work or an occupational disease which had occurred or had been confirmed previously under the legislation it applies; and (b) no compensation is due in respect of an accident at work or an occupational disease which had occurred or had been confirmed subsequently, under the legislation of the other State under which the accident at work or the occupational disease had occurred or been confirmed. Article SSC.36 Reimbursements between institutions 1. Article SSC.30 also applies to benefits falling within this Chapter, and reimbursement shall be made on the basis of actual costs. 2. The States, or their competent authorities, may provide for other methods of reimbursement or waive all reimbursement between the institutions under their jurisdiction. CHAPTER 3 DEATH GRANTS Article SSC.37 Right to grants where death occurs in, or where the person entitled resides in, a State other than the competent one 1. When an insured person or a member of their family dies in a State other than the competent State, the death shall be deemed to have occurred in the competent State. 2. The competent institution shall be obliged to provide death grants payable under the legislation it applies, even if the person entitled resides in a State other than the competent State. 3. Paragraphs 1 and 2 shall also apply when the death is the result of an accident at work or an occupational disease. Article SSC.38 Provision of benefits in the event of the death of a pensioner 1. In the event of the death of a pensioner who was entitled to a pension under the legislation of one State, or to pensions under the legislations of two or more States, when that pensioner was residing in a State other than that of the institution responsible for the cost of benefits in kind provided under Articles SSC.22 and SSC.23, the death grants payable under the legislation administered by that institution shall be provided at its own expense as though the pensioner had been residing at the time of their death in the State in which that institution is situated. 2. Paragraph 1 applies mutatis mutandis to the members of the family of a pensioner. CHAPTER 4 INVALIDITY BENEFITS Article SSC.39 Calculation of invalidity benefits Without prejudice to Article SSC.7, where, under the legislation of the State competent under Title II of this Protocol, the amount of invalidity benefits is dependent on the duration of the periods of insurance, employment, self-employment or residence, the competent State is not required to take into account any such periods completed under the legislation of another State for the purposes of calculating the amount of invalidity benefit payable. Article SSC.40 Special provisions on aggregation of periods The competent institution of a State whose legislation makes the acquisition, retention or recovery of the right to benefits conditional upon the completion of periods of insurance or residence shall, where necessary, apply Article SSC.46 mutatis mutandis. Article SSC.41 Aggravation of invalidity In the case of aggravation of an invalidity for which a person is receiving benefits under the legislation of a State in accordance with this Protocol, the benefit shall continue to be provided in accordance with this Chapter, taking the aggravation into account. Article SSC.42 Conversion of invalidity benefits into old-age benefits 1. Where provided for in the legislation of the State paying invalidity benefit in accordance with this Protocol, invalidity benefits shall be converted into old-age benefits under the conditions laid down by the legislation under which they are provided and in accordance with Chapter 5 of Title III. 2. Where a person receiving invalidity benefits can establish a claim to old-age benefits under the legislation of one or more other States, in accordance with Article SSC.45, any institution which is responsible for providing invalidity benefits under the legislation of a State shall continue to provide such a person with the invalidity benefits to which he or she is entitled under the legislation it applies until paragraph 1 becomes applicable in respect of that institution, or otherwise for as long as the person concerned satisfies the conditions for such benefits. Article SSC.43 Special provisions for civil servants Articles SSC.7, SSC.39, SSC.41, SSC.42 and Article SSC.55(2) and (3) apply mutatis mutandis to persons covered by a special scheme for civil servants. CHAPTER 5 OLD-AGE AND SURVIVORS' PENSIONS Article SSC.44 Taking into account child-raising periods 1. Where, under the legislation of the State which is competent under Title II, no child-raising period is taken into account, the institution of the State whose legislation, according to Title II, was applicable to the person concerned on the grounds that he or she was pursuing an activity as an employed or self-employed person at the date when, under that legislation, the child-raising period started to be taken into account for the child concerned, shall remain responsible for taking into account that period as a child-raising period under its own legislation, as if such child-raising took place in its own territory. 2. Paragraph 1 shall not apply if the person concerned is, or becomes, subject to the legislation of another State due to the pursuit of an employed or self-employed activity. Article SSC.45 General provisions 1. All the competent institutions shall determine entitlement to benefit, under all the legislations of the States to which the person concerned has been subject, when a request for award has been submitted, unless the person concerned expressly requests deferment of the award of old age benefits under the legislation of one or more States. 2. If at a given moment the person concerned does not satisfy, or no longer satisfies, the conditions laid down by all the legislations of the States to which that person has been subject, the institutions applying legislation the conditions of which have been satisfied shall not take into account, when performing the calculation in accordance with point (a) or (b) of Article SSC.47(1), the periods completed under the legislations the conditions of which have not been satisfied, or are no longer satisfied, where this gives rise to a lower amount of benefit. 3. Paragraph 2 shall apply mutatis mutandis when the person concerned has expressly requested deferment of the award of old-age benefits. 4. A new calculation shall be performed automatically as and when the conditions to be fulfilled under the other legislations are satisfied or when a person requests the award of an old-age benefit deferred in accordance with paragraph 1, unless the periods completed under the other legislations have already been taken into account by virtue of paragraph 2 or 3. Article SSC.46 Special provisions on aggregation of periods 1. Where the legislation of a State makes the granting of certain benefits conditional upon the periods of insurance having been completed only in a specific activity as an employed or self-employed person or in an occupation which is subject to a special scheme for employed or self-employed persons, the competent institution of that State shall take into account periods completed under the legislation of other States only if completed under a corresponding scheme or, failing that, in the same occupation, or where appropriate, in the same activity as an employed or self-employed person. If, account having been taken of the periods thus completed, the person concerned does not satisfy the conditions for receipt of the benefits of a special scheme, these periods shall be taken into account for the purposes of providing the benefits of the general scheme or, failing that, of the scheme applicable to manual or clerical workers, as the case may be, provided that the person concerned had been affiliated to one or other of those schemes. 2. The periods of insurance completed under a special scheme of a State shall be taken into account for the purposes of providing the benefits of the general scheme or, failing that, of the scheme applicable to manual or clerical workers, as the case may be, of another State, provided that the person concerned had been affiliated to one or other of those schemes, even if those periods have already been taken into account in the latter State under a special scheme. 3. Where the legislation or specific scheme of a State makes the acquisition, retention or recovery of the right to benefits conditional upon the person concerned being insured at the time of the materialisation of the risk, this condition shall be regarded as having been satisfied if that person has been previously insured under the legislation or specific scheme of that State and is, at the time of the materialisation of the risk, insured under the legislation of another State for the same risk or, failing that, if a benefit is due under the legislation of another State for the same risk. The latter condition shall, however, be deemed to be fulfilled in the cases referred to in Article SSC.52. Article SSC.47 Award of benefits 1. The competent institution shall calculate the amount of the benefit that would be due: (a) under the legislation it applies, only where the conditions for entitlement to benefits have been satisfied exclusively under national law (independent benefit); (b) by calculating a theoretical amount and subsequently an actual amount (pro rata benefit), as follows: (i) the theoretical amount of the benefit is equal to the benefit which the person concerned could claim if all the periods of insurance and/or of residence which have been completed under the legislations of the other States had been completed under the legislation it applies on the date of the award of the benefit. If, under this legislation, the amount does not depend on the duration of the periods completed, that amount shall be regarded as being the theoretical amount; (ii) the competent institution shall then establish the actual amount of the pro rata benefit by applying to the theoretical amount the ratio between the duration of the periods completed before materialisation of the risk under the legislation it applies and the total duration of the periods completed before materialisation of the risk under the legislations of all the States concerned. 2. Where appropriate, the competent institution shall apply, to the amount calculated in accordance with points (a) and (b) of paragraph 1, all the rules relating to reduction, suspension or withdrawal, under the legislation it applies, within the limits provided for by Articles SSC.48, SSC.49 and SSC.50. 3. The person concerned shall be entitled to receive from the competent institution of each State the higher of the amounts calculated in accordance with points (a) and (b) of paragraph 1. 4. Where the calculation pursuant to point (a) of paragraph 1 in one State invariably results in the independent benefit being equal to or higher than the pro rata benefit, calculated in accordance with point (b) of paragraph 1, the competent institution shall waive the pro rata calculation, provided that: (a) such a situation is set out in Part 1 of Annex SSC-4; (b) no legislation containing rules against overlapping, as referred to in Articles SSC.49 and SSC.50, is applicable unless the conditions laid down in Article SSC.50(2) are fulfilled; and (c) Article SSC.52 is not applicable in relation to periods completed under the legislation of another State in the specific circumstances of the case. 5. Notwithstanding paragraphs 1, 2 and 3, the pro rata calculation shall not apply to schemes providing benefits in respect of which periods of time are of no relevance to the calculation, subject to such schemes being listed in Part 2 of Annex SSC-4. In such cases, the person concerned shall be entitled to the benefit calculated in accordance with the legislation of the State concerned. Article SSC.48 Rules to prevent overlapping 1. Any overlapping of old-age and survivors' benefits calculated or provided on the basis of periods of insurance or residence completed by the same person shall be considered to be overlapping of benefits of the same kind. 2. Overlapping of benefits which cannot be considered to be of the same kind within the meaning of paragraph 1 shall be considered to be overlapping of benefits of a different kind. 3. The following provisions shall be applicable for the purposes of rules to prevent overlapping laid down by the legislation of a State in the case of overlapping of a benefit in respect of old age or survivors with a benefit of the same kind or a benefit of a different kind or with other income: (a) the competent institution shall take into account the benefits or incomes acquired in another State only where the legislation it applies provides for benefits or income acquired abroad to be taken into account; (b) the competent institution shall take into account the amount of benefits to be paid by another State before deduction of tax, social security contributions and other individual levies or deductions, unless the legislation it applies provides for the application of rules to prevent overlapping after such deductions, under the conditions and the procedures laid down in Annex SSC-7; (c) the competent institution shall not take into account the amount of benefits acquired under the legislation of another State on the basis of voluntary insurance or continued optional insurance; (d) if a single State applies rules to prevent overlapping because the person concerned receives benefits of the same or of a different kind under the legislation of other States or income acquired in other States, the benefit due may be reduced solely by the amount of such benefits or such income. Article SSC.49 Overlapping of benefits of the same kind 1. Where benefits of the same kind due under the legislation of two or more States overlap, the rules to prevent overlapping laid down by the legislation of a State shall not be applicable to a pro rata benefit. 2. The rules to prevent overlapping shall apply to an independent benefit only if the benefit concerned is: (a) a benefit the amount of which does not depend on the duration of periods of insurance or residence; or (b) a benefit the amount of which is determined on the basis of a credited period deemed to have been completed between the date on which the risk materialised and a later date, overlapping with: (i) a benefit of the same type, except where an agreement has been concluded between two or more States to avoid the same credited period being taken into account more than once; or (ii) a benefit referred to in point (a). The benefits and agreements referred to in points (a) and (b) are listed in Annex SSC-5. Article SSC.50 Overlapping of benefits of a different kind 1. If the receipt of benefits of a different kind or other income requires the application of the rules to prevent overlapping provided for by the legislation of the States concerned regarding: (a) two or more independent benefits, the competent institutions shall divide the amounts of the benefit or benefits or other income, as they have been taken into account, by the number of benefits subject to the said rules; however, the application of this point cannot deprive the person concerned of their status as a pensioner for the purposes of the other chapters of this Title under the conditions and the procedures laid down in Annex SSC-7; (b) one or more pro rata benefits, the competent institutions shall take into account the benefit or benefits or other income and all the elements stipulated for applying the rules to prevent overlapping as a function of the ratio between the periods of insurance and/or residence established for the calculation referred to in point (b)(ii) of Article SSC.47(1); (c) one or more independent benefits and one or more pro-rata benefits, the competent institutions shall apply mutatis mutandis point (a) as regards independent benefits and point (b) as regards pro rata benefits. 2. The competent institution shall not apply the division stipulated in respect of independent benefits, if the legislation it applies provides for account to be taken of benefits of a different kind or other income and all other elements for calculating part of their amount determined as a function of the ratio between periods of insurance and/or residence referred to in point (b)(ii) of Article SSC.47(1). 3. Paragraphs 1 and 2 shall apply mutatis mutandis where the legislation of one or more States provides that a right to a benefit cannot be acquired in the case where the person concerned is in receipt of a benefit of a different kind, payable under the legislation of another State, or of other income. Article SSC.51 Additional provisions for the calculation of benefits 1. For the calculation of the theoretical and pro rata amounts referred to in point (b) of Article SSC.47(1), the following rules apply: (a) where the total length of the periods of insurance and/or residence completed before the risk materialised under the legislations of all the States concerned is longer than the maximum period required by the legislation of one of these States for receipt of full benefit, the competent institution of that State shall take into account this maximum period instead of the total length of the periods completed; this method of calculation shall not result in the imposition on that institution of the cost of a benefit greater than the full benefit provided for by the legislation it applies. This provision shall not apply to benefits the amount of which does not depend on the length of insurance; (b) the procedure for taking into account overlapping periods is laid down in Annex SSC-7; (c) if the legislation of a State provides that the benefits are to be calculated on the basis of incomes, contributions, bases of contributions, increases, earnings, other amounts or a combination of more than one of them (average, proportional, fixed or credited), the competent institution shall: (i) determine the basis for calculation of the benefits in accordance only with periods of insurance completed under the legislation it applies; (ii) use, in order to determine the amount to be calculated in accordance with the periods of insurance and/or residence completed under the legislation of the other States, the same elements determined or recorded for the periods of insurance completed under the legislation it applies; where necessary in accordance with the procedures laid down in Annex SSC-6 for the State concerned; (d) in the event that point (c) is not applicable because the legislation of a State provides for the benefit to be calculated on the basis of elements other than periods of insurance or residence which are not linked to time, the competent institution shall take into account, in respect of each period of insurance or residence completed under the legislation of any other State, the amount of the capital accrued, the capital which is considered as having been accrued or any other element for the calculation under the legislation it administers divided by the corresponding units of periods in the pension scheme concerned. 2. The provisions of the legislation of a State concerning the revalorisation of the elements taken into account for the calculation of benefits shall apply, as appropriate, to the elements to be taken into account by the competent institution of that State, in accordance with paragraph 1, in respect of the periods of insurance or residence completed under the legislation of other States. Article SSC.52 Periods of insurance or residence of less than one year 1. Notwithstanding point (b) of Article SSC.47(1), the institution of a State shall not be required to provide benefits in respect of periods completed under the legislation it applies which are taken into account when the risk materialises, if: (a) the duration of the said periods is less than one year; and (b) taking only these periods into account no right to benefit is acquired under that legislation. For the purposes of this Article, \"periods\" shall mean all periods of insurance, employment, self-employment or residence which either qualify for, or directly increase, the benefit concerned. 2. The competent institution of each of the States concerned shall take into account the periods referred to in paragraph 1, for the purposes of point (b)(i) of Article SSC.47(1). 3. If the effect of applying paragraph 1 would be to relieve all the institutions of the States concerned of their obligations, benefits shall be provided exclusively under the legislation of the last of those States whose conditions are satisfied, as if all the periods of insurance and residence completed and taken into account in accordance with Article SSC.7 and Article SSC.46(1) and (2) had been completed under the legislation of that State. 4. This Article does not apply to schemes listed in Part 2 of Annex SSC-4. Article SSC.53 Award of a supplement 1. A recipient of benefits to whom this Chapter applies may not, in the State of residence and under whose legislation a benefit is payable to them, be provided with a benefit which is less than the minimum benefit fixed by that legislation for a period of insurance or residence equal to all the periods taken into account for the payment in accordance with this Chapter. 2. The competent institution of that State shall pay them throughout the period of their residence in its territory a supplement equal to the difference between the total of the benefits due under this Chapter and the amount of the minimum benefit. Article SSC.54 Recalculation and revaluation of benefits 1. If the method for determining benefits or the rules for calculating benefits are altered under the legislation of a State, or if the personal situation of the person concerned undergoes a relevant change which, under that legislation, would lead to an adjustment of the amount of the benefit, a recalculation shall be carried out in accordance with Article SSC.47. 2. On the other hand, if, by reason of an increase in the cost of living or changes in the level of income or other grounds for adjustment, the benefits of the State concerned are altered by a percentage or fixed amount, such percentage or fixed amount shall be applied directly to the benefits determined in accordance with Article SSC.47, without the need for a recalculation. Article SSC.55 Special provisions for civil servants 1. Articles SSC.7 and SSC.45, Article SSC.46(3) and Articles SSC.47 to SSC.54 apply mutatis mutandis to persons covered by a special scheme for civil servants. 2. However, if the legislation of a competent State makes the acquisition, liquidation, retention or recovery of the right to benefits under a special scheme for civil servants subject to the condition that all periods of insurance be completed under one or more special schemes for civil servants in that State, or be regarded by the legislation of that State as equivalent to such periods, the competent institution of that State shall take into account only the periods which can be recognised under the legislation it applies. If, account having been taken of the periods thus completed, the person concerned does not satisfy the conditions for the receipt of these benefits, these periods shall be taken into account for the award of benefits under the general scheme or, failing that, the scheme applicable to manual or clerical workers, as the case may be. 3. Where, under the legislation of a State, benefits under a special scheme for civil servants are calculated on the basis of the last salary or salaries received during a reference period, the competent institution of that State shall take into account, for the purposes of the calculation, only those salaries, duly revalued, which were received during the period or periods for which the person concerned was subject to that legislation. CHAPTER 6 UNEMPLOYMENT BENEFITS Article SSC.56 Special provisions on aggregation of periods of insurance, employment or self-employment 1. The competent institution of a State whose legislation makes the acquisition, retention, recovery or duration of the right to benefits conditional upon the completion of either periods of insurance, employment or self-employment shall, to the extent necessary, take into account periods of insurance, employment or self-employment completed under the legislation of any other State as though they were completed under the legislation it applies. However, when the applicable legislation makes the right to benefits conditional on the completion of periods of insurance, the periods of employment or self-employment completed under the legislation of another State shall not be taken into account unless such periods would have been considered to be periods of insurance had they been completed in accordance with the applicable legislation. 2. The application of paragraph 1 of this Article shall be conditional on the person concerned having the most recently completed, in accordance with the legislation under which the benefits are claimed: (a) periods of insurance, if that legislation requires periods of insurance; (b) periods of employment, if that legislation requires periods of employment; or (c) periods of self-employment, if that legislation requires periods of self-employment. Article SSC.57 Calculation of unemployment benefits 1. Where the calculation of unemployment benefits is based on the amount of the previous salary or professional income of the person concerned, the competent State shall take into account the salary or professional income received by the person concerned based exclusively on their last activity as an employed or self-employed person under the legislation of the competent State. 2. Where the legislation applied by the competent State provides for a specific reference period for the determination of the salary or professional income used to calculate the amount of benefit, and the person concerned was subject to the legislation of another State for all or part of that reference period, the competent State shall only take into account the salary or professional income received during their last activity as an employed or self-employed person under that legislation. CHAPTER 7 PRE-RETIREMENT BENEFITS Article SSC.58 Benefits When the applicable legislation makes the right to pre-retirement benefits conditional on the completion of periods of insurance, of employment or of self-employment, Article SSC.7 shall not apply. TITLE IV MISCELLANEOUS PROVISIONS Article SSC.59 Cooperation 1. The competent authorities of the States shall notify the Specialised Committee on Social Security Coordination of any changes to their legislation as regards the branches of social security covered by Article SSC.3 which are relevant to or may affect the implementation of this Protocol. 2. Unless this Protocol requires such information to be notified to the Specialised Committee on Social Security Coordination, the competent authorities of the States shall communicate to each other measures taken to implement this Protocol that are not notified under paragraph 1 and that are relevant for the implementation of this Protocol. 3. For the purposes of this Protocol, the authorities and institutions of the States shall lend one another their good offices and act as though implementing their own legislation. The administrative assistance given by those authorities and institutions shall, as a rule, be free of charge. However, the Specialised Committee on Social Security Coordination shall establish the nature of reimbursable expenses and the limits above which their reimbursement is due. 4. The authorities and institutions of the States may, for the purposes of this Protocol, communicate directly with one another and with the persons involved or their representatives. 5. The institutions and persons covered by this Protocol shall have a duty of mutual information and cooperation to ensure the correct implementation of this Protocol. The institutions, in accordance with the principle of good administration, shall respond to all queries within a reasonable period of time and shall in this connection provide the persons concerned with any information required for exercising the rights conferred on them by this Protocol. The persons concerned must inform the institutions of the competent State and of the State of residence as soon as possible of any change in their personal or family situation which affects their right to benefits under this Protocol. 6. Failure to respect the obligation of information referred to in the third subparagraph of paragraph 5 may result in the application of proportionate measures in accordance with national law. Nevertheless, these measures shall be equivalent to those applicable to similar situations under domestic law and shall not make it impossible or excessively difficult in practice for claimants to exercise the rights conferred on them by this Protocol. 7. In the event of difficulties in the interpretation or application of this Protocol which could jeopardise the rights of a person covered by it, the institution of the competent State or of the State of residence of the person concerned, shall contact the institution(s) of the State(s) concerned. If a solution cannot be found within a reasonable period, a Party may request to hold consultations in the framework of the Specialised Committee on Social Security Coordination. 8. The authorities, institutions and tribunals of one State may not reject applications or other documents submitted to them on the grounds that they are written in an official language of the Union, including in English. Article SSC.60 Data processing 1. The States shall progressively use new technologies for the exchange, access and processing of the data required to apply this Protocol. 2. Each State shall be responsible for managing its own part of the data-processing services. 3. An electronic document sent or issued by an institution in conformity with this Protocol and Annex SSC-7 may not be rejected by any authority or institution of another State on the grounds that it was received by electronic means, once the receiving institution has declared that it can receive electronic documents. Reproduction and recording of such documents shall be presumed to be a correct and accurate reproduction of the original document or representation of the information it relates to, unless there is proof to the contrary. 4. An electronic document shall be considered valid if the computer system on which the document is recorded contains the safeguards necessary in order to prevent any alteration, disclosure or unauthorised access to the recording. It shall at any time be possible to reproduce the recorded information in an immediately readable form. Article SSC.61 Exemptions 1. Any exemption from or reduction of taxes, stamp duty, notarial or registration fees provided for under the legislation of one State in respect of certificates or documents required to be produced in application of the legislation of that State shall be extended to similar certificates or documents required to be produced in application of the legislation of another State or of this Protocol. 2. All statements, documents and certificates of any kind whatsoever required to be produced in application of this Protocol shall be exempt from authentication by diplomatic or consular authorities. Article SSC.62 Claims, declarations or appeals Any claim, declaration or appeal which should have been submitted, in application of the legislation of one State, within a specified period to an authority, institution or tribunal of that State shall be admissible if it is submitted within the same period to a corresponding authority, institution or tribunal of another State. In such a case, the authority, institution or tribunal receiving the claim, declaration or appeal shall forward it without delay to the competent authority, institution or tribunal of the former State either directly or through the competent authorities of the States concerned. The date on which such claims, declarations or appeals were submitted to the authority, institution or tribunal of the second State shall be considered as the date of their submission to the competent authority, institution or tribunal. Article SSC.63 Medical examinations 1. Medical examinations provided for by the legislation of one State may be carried out, at the request of the competent institution, in the territory of another State, by the institution of the place of stay or residence of the person entitled to benefits, under the conditions laid down in Annex SSC-7 or agreed between the competent authorities of the States concerned. 2. Medical examinations carried out under the conditions laid down in paragraph 1 shall be considered as having been carried out in the territory of the competent State. Article SSC.64 Collection of contributions and recovery of benefits 1. Collection of contributions due to an institution of one State and recovery of benefits provided by the institution of one State but not due, may be effected in another State in accordance with the procedures and with the guarantees and privileges applicable to the collection of contributions due to the corresponding institution of the latter and the recovery of benefits provided by it but not due. 2. Enforceable decisions of the judicial and administrative authorities relating to the collection of contributions, interest and any other charges or to the recovery of benefits provided but not due under the legislation of one State shall be recognised and enforced at the request of the competent institution in another State within the limits and in accordance with the procedures laid down by the legislation and any other procedures applicable to similar decisions of the latter. Such decisions shall be declared enforceable in that State insofar as the legislation and any other procedures of that State so require. 3. Claims of an institution of one State shall in enforcement, bankruptcy or settlement proceedings in another State enjoy the same privileges as the legislation that the latter accords to claims of the same kind. 4. The procedure for implementing this Article, including costs reimbursement, shall be governed by Annex SSC-7 or, where necessary and as a complementary measure, by means of agreements between the States. Article SSC.65 Rights of institutions 1. If a person receives benefits under the legislation of a State in respect of an injury resulting from events occurring in another State, any rights of the institution responsible for providing benefits against a third party liable to provide compensation for the injury shall be governed by the following rules: (a) where the institution responsible for providing benefits is, under the legislation it applies, subrogated to the rights which the beneficiary has against the third party, such subrogation shall be recognised by each State; (b) where the institution responsible for providing benefits has a direct right against the third party, each State shall recognise such rights. 2. If a person receives benefits under the legislation of one State in respect of an injury resulting from events occurring in another State, the provisions of the said legislation which determine the cases in which the civil liability of employers or of their employees is to be excluded shall apply with regard to the said person or to the competent institution. Paragraph 1 shall also apply to any rights of the institution responsible for providing benefits against employers or their employees in cases where their liability is not excluded. 3. Where, in accordance with Article SSC.30(3) or SSC.36(2), two or more States or their competent authorities have concluded an agreement to waive reimbursement between institutions under their jurisdiction, or, where reimbursement does not depend on the amount of benefits actually provided, any rights arising against a liable third party shall be governed by the following rules: (a) where the institution of the State of residence or stay grants benefits to a person in respect of an injury sustained in its territory, that institution, in accordance with the provisions of the legislation it applies, shall exercise the right to subrogation or direct action against the third party liable to provide compensation for the injury; (b) for the application of point (a): (i) the person receiving benefits shall be deemed to be insured with the institution of the place of residence or stay, and (ii) that institution shall be deemed to be the institution responsible for providing benefits; (c) paragraphs 1 and 2 shall remain applicable in respect of any benefits not covered by the waiver agreement or a reimbursement which does not depend on the amount of benefits actually provided. Article SSC.66 Implementation of legislation Special provisions for implementing the legislation of a certain State are referred to in Annex SSC-6 to the Protocol. TITLE V FINAL PROVISIONS Article SSC.67 Protection of individual rights 1. The Parties shall ensure in accordance with their domestic legal orders that the provisions of the Protocol on Social Security Coordination have the force of law, either directly or through domestic legislation giving effect to those provisions, so that legal or natural persons can invoke those provisions before domestic courts, tribunals and administrative authorities. 2. The Parties shall ensure the means for legal and natural persons to effectively protect their rights under this Protocol, such as the possibility to address complaints to administrative bodies or to bring legal action before a competent court or tribunal in an appropriate judicial procedure, in order to seek an adequate and timely remedy. Article SSC.68 Amendments The Specialised Committee on Social Security Coordination may amend the Annexes and Appendices to this Protocol. Article SSC.69 Termination of this Protocol Without prejudice to Article 779 of this Agreement, each Party may at any moment terminate this Protocol, by written notification through diplomatic channels. In that event, this Protocol shall cease to be in force on the first day of the ninth month following the date of notification. Article SSC.70 Sunset clause 1. This Protocol shall cease to apply fifteen years after the entry into force of this Agreement. 2. Not less than 12 months before this Protocol ceases to apply in accordance with paragraph 1, either Party shall notify the other Party of its wish to enter into negotiations with a view to concluding an updated Protocol. Article SSC.71 Post-termination arrangements When this Protocol ceases to apply pursuant to Article SSC.69, Article SSC.70 or Article 779 of this Agreement, the rights of insured persons regarding entitlements which are based on periods completed or facts or events that occurred before this Protocol ceases to apply shall be retained. The Partnership Council may lay down additional arrangements setting out appropriate consequential and transitional arrangements in good time before this Protocol ceases to apply. ANNEX SSC-1 CERTAIN BENEFITS IN CASH TO WHICH THIS PROTOCOL SHALL NOT APPLY PART 1 SPECIAL NON-CONTRIBUTORY CASH BENEFITS (Point (a) of Article SSC.3(4) of this Protocol) (i) UNITED KINGDOM (a) State Pension Credit (State Pension Credit Act 2002 and State Pension Credit Act (Northern Ireland) 2002); (b) Income-based allowances for jobseekers (Jobseekers Act 1995 and Jobseekers (Northern Ireland) Order 1995); (c) Disability Living Allowance, mobility component (Social Security Contributions and Benefits Act 1992 and Social Security Contributions and Benefits (Northern Ireland) Act 1992); (d) Personal Independence Payment, mobility component (Welfare Reform Act 2012 (Part 4) and Welfare Reform (Northern Ireland) Order 2015 (Part 5)); (e) Employment and Support Allowance Income-related (Welfare Reform Act 2007 and Welfare Reform Act (Northern Ireland) 2007); (f) Best Start Foods payment (Welfare Foods (Best Start Foods) (Scotland) Regulations 2019 (SSI 2019/193)); (g) Best Start Grants (pregnancy and baby grant, early learning grant, school-age grant) (The Early Years Assistance (Best Start Grants) (Scotland) Regulations 2018 (SSI 2018/370)); (h) Funeral Support Payment (Funeral Expense Assistance (Scotland) Regulations 2019 (SSI 2019/292)). (ii) MEMBER STATES AUSTRIA Compensatory supplement (Federal Act of 9 September 1955 on General Social Insurance \u2014 ASVG, Federal Act of 11 October 1978 on Social insurance for persons engaged in trade and commerce \u2014 GSVG and Federal Act of 11 October 1978 on Social insurance for farmers \u2014 BSVG). BELGIUM (a) Income replacement allowance (Law of 27 February 1987); (b) Guaranteed income for elderly persons (Law of 22 March 2001). BULGARIA Social Pension for old age (Article 89 of the Social Insurance Code). CYPRUS (a) Social Pension (Social Pension Law of 1995 (Law 25(I)/95), as amended); (b) Severe motor disability allowance (Council of Ministers' Decisions Nos 38210 of 16 October 1992, 41370 of 1 August 1994, 46183 of 11 June 1997 and 53675 of 16 May 2001); (c) Special grant to blind persons (Special Grants Law of 1996 (Law 77(I)/96), as amended). CZECH REPUBLIC Social allowance (State Social Support Act No 117/1995 Sb.). DENMARK Accommodation expenses for pensioners (Law on individual accommodation assistance, consolidated by Law No 204 of 29 March 1995). ESTONIA (a) Disabled adult allowance (Social Benefits for Disabled Persons Act of 27 January 1999); (b) State unemployment allowance (Labour Market Services and Support Act of 29 September 2005). FINLAND (a) Housing allowance for pensioners (Act concerning the Housing Allowance for pensioners, 571/2007); (b) Labour market support (Act on Unemployment Benefits 1290/2002); (c) Special assistance for immigrants (Act on Special Assistance for Immigrants, 1192/2002). FRANCE (a) Supplementary allowances of: (i) the Special Invalidity Fund; and (ii) the Old Age Solidarity Fund in respect of acquired rights (Law of 30 June 1956, codified in Book VIII of the Social Security Code); (b) Disabled adults' allowance (Law of 30 June 1975, codified in Book VIII of the Social Security Code); (c) Special allowance (Law of 10 July 1952, codified in Book VIII of the Social Security Code) in respect of acquired rights; (d) Old-age solidarity allowance (ordinance of 24 June 2004, codified in Book VIII of the Social Security Code) as of 1 January 2006. GERMANY (a) Basic subsistence income for the elderly and for persons with reduced earning capacity under Chapter 4 of Book XII of the Social Code; (b) Benefits to cover subsistence costs under the basic provision for jobseekers unless, with respect to these benefits, the eligibility requirements for a temporary supplement following receipt of unemployment benefit (Article 24(1) of Book II of the Social Code) are fulfilled. GREECE Special benefits for the elderly (Law 1296/82). HUNGARY (a) Invalidity annuity (Decree No 83/1987 (XII 27) of the Council of Ministers on Invalidity Annuity); (b) Non-contributory old age allowance (Act III of 1993 on Social Administration and Social Benefits); (c) Transport allowance (Government Decree No 164/1995 (XII 27) on Transport Allowances for Persons with Severe Physical Handicap). IRELAND (a) Jobseekers' allowance (Social Welfare Consolidation Act 2005, Part 3, Chapter 2); (b) State pension (non-contributory) (Social Welfare Consolidation Act 2005, Part 3, Chapter 4); (c) Widow's (non-contributory) pension and widower's (non-contributory) pension (Social Welfare Consolidation Act 2005, Part 3, Chapter 6); (d) Disability allowance (Social Welfare Consolidation Act 2005, Part 3, Chapter 10); (e) Mobility allowance (Health Act 1970, Section 61); (f) Blind pension (Social Welfare Consolidation Act 2005, Part 3, Chapter 5). ITALY (a) Social pensions for persons without means (Law No 153 of 30 April 1969); (b) Pensions and allowances for the civilian disabled or invalids (Laws No 118 of 30 March 1971, No 18 of 11 February 1980 and No 508 of 21 November 1988); (c) Pensions and allowances for the deaf and dumb (Laws No 381 of 26 May 1970 and No 508 of 21 November 1988); (d) Pensions and allowances for the civilian blind (Laws No 382 of 27 May 1970 and No 508 of 21 November 1988); (e) Benefits supplementing the minimum pensions (Laws No 218 of 4 April 1952, No 638 of 11 November 1983 and No 407 of 29 December 1990); (f) Benefits supplementing disability allowances (Law No 222 of 12 June 1984); (g) Social allowance (Law No 335 of 8 August 1995); (h) Social increase (Article 1(1) and (12) of Law No 544 of 29 December 1988 and successive amendments). LATVIA (a) State Social Security Benefit (Law on State Social Benefits of 1 January 2003); (b) Allowance for the compensation of transportation expenses for disabled persons with restricted mobility (Law on State Social Benefits of 1 January 2003). LITHUANIA (a) Social assistance pension (Law of 2005 on State Social Assistance Benefits, Article 5); (b) Relief compensation (Law of 2005 on State Social Assistance Benefits, Article 15); (c) Transport compensation for the disabled who have mobility problems (Law of 2000 on Transport Compensation, Article 7). LUXEMBOURG Income for the seriously disabled (Article 1(2), Law of 12 September 2003), with the exception of persons recognised as being disabled workers and employed on the mainstream labour market or in a sheltered environment. MALTA (a) Supplementary allowance (Section 73 of the Social Security Act (Cap. 318) 1987); (b) Age pension (Social Security Act (Cap. 318) 1987). NETHERLANDS (a) Work and Employment Support for Disabled Young Persons Act of 24 April 1997 (Wet Wajong). (b) Supplementary Benefits Act of 6 November 1986 (TW). POLAND Social pension (Act of 27 June 2003 on social pensions). PORTUGAL (a) Non-contributory State old-age and invalidity pension (Decree-Law No 464/80 of 13 October 1980); (b) Non-contributory widowhood pension (Regulatory Decree No 52/81 of 11 November 1981); (c) Solidarity supplement for the elderly (Decree \u2013 Law No 232/2005 of 29 December 2005, amended by Decree \u2013 Law No 236/2006 of 11 December 2006). SLOVAKIA (a) Adjustment awarded before 1 January 2004 to pensions constituting the sole source of income; (b) Social pension which has been awarded before 1 January 2004. SLOVENIA (a) State pension (Pension and Disability Insurance Act of 23 December 1999); (b) Income support for pensioners (Pension and Disability Insurance Act of 23 December 1999); (c) Maintenance allowance (Pension and Disability Insurance Act of 23 December 1999). SPAIN (a) Minimum income guarantee (Law No 13/82 of 7 April 1982); (b) Cash benefits to assist the elderly and invalids unable to work (Royal Decree No 2620/81 of 24 July 1981): (i) Non-contributory invalidity and retirement pensions as provided for in Chapter II of Title VI of the Consolidated Text of the General Law on Social Security, approved by Royal Legislative Decree No 8/2015 of 30 October 2015; and (ii) the benefits which supplement the above pensions, as provided for in the legislation of the Comunidades Auton\u00f3mas, where such supplements guarantee a minimum subsistence income having regard to the economic and social situation in the Comunidades Auton\u00f3mas concerned; (c) Allowances to promote mobility and to compensate for transport costs (Law No 13/1982 of 7 April 1982). SWEDEN (a) Housing supplements for persons receiving a pension (Law 2001:761); (b) Financial support for the elderly (Law 2001:853). PART 2 LONG-TERM CARE BENEFITS (Point (d) of Article SSC.3(4) of this Protocol) (i) UNITED KINGDOM (a) Attendance Allowance (Social Security Contributions and Benefits Act 1992, Social Security (Attendance Allowance) Regulations 1991, Social Security Contributions and Benefits (Northern Ireland) Act 1992 and Social Security (Attendance Allowance) Regulations (Northern Ireland) 1992); (b) Carer's Allowance (Social Security Contributions and Benefits Act 1992, The Social Security (Invalid Care Allowance) Regulations 1976, Social Security Contributions and Benefits (Northern Ireland) Act 1992) and The Social Security (Invalid Care Allowance) Regulations 1976 (Northern Ireland); (c) Disability Living Allowance, care component (Social Security Contributions and Benefits Act 1992, Social Security (Disability Living Allowance) Regulations 1991, Social Security Contributions and Benefits (Northern Ireland) Act 1992 and Social Security (Disability Living Allowance) Regulations (Northern Ireland) 1992); (d) Personal Independence Payment, daily living component (Welfare Reform Act 2012 (Part 4), Social Security (Personal Independence Payment) Regulations 2013, The Personal Independence Payment (Transitional Provisions) Regulations 2013, Personal Independence Payment (Transitional Provisions) (Amendment) Regulations 2019, Welfare Reform (Northern Ireland) Order 2015 (Part 5), The Personal Independence Payment Regulations (Northern Ireland) 2016, The Personal Independence Payment (Transitional Provisions) Regulations (Northern Ireland) 2016 and Personal Independence Payment (Transitional Provisions) (Amendment) Regulations (Northern Ireland) 2019; (e) Carer's Allowance Supplement (The Social Security (Scotland) Act 2018); (f) Young Carer's Grant (The Carer's Assistance (Young Carer Grants) (Scotland) Regulations 2020 (as amended)). (ii) MEMBER STATES AUSTRIA (a) Federal Long-term care allowance Act (Bundespflegegeldgesetz, BPGG), original version BGBl. no. 110/1993, last amendment BGBl- I no. 100/2016 (b) Regulation on the staging of the Federal long-term care allowance (Einstufungsverordnung zum Bundespflegegeldgesetz (EinstV)): (c) Regulation of the Federal minister for Labour, Social affairs and Consumer protection on needs assessments of care for children and young people in accordance with the Federal Nursing Care Act. (Bundespflegegeldgesetz, Kinder-EinstV) (d) Numerous applicable statutory bases, e.g. Agreement between the Federal Government and the L\u00e4nder on joint measures for persons in need of care. Social Assistance Acts and Disability Acts of the L\u00e4nder. (e) Care Fund Law (Pflegefondsgesetz, PFG), Original version: Official Journal (BGBI. I) No. 57/2011. (f) Care Services Statistics Ordinance 2012 (Pflegedienstleistungsstatistik-Verordnung 2012) (g) Support for the 24-hour care: Federal Long-term care allowance Act (Bundespflegegeldgesetz, BPGG): (h) Guidelines for the support of the 24-hour care (\u00a7 21b of the Federal Long-term care allowance Act (Bundespflegegeldgesetz)) (i) Guidelines for granting benefits to support caring family members (\u00a7 21a of the Federal Long-term care allowance Act (Bundespflegegeldgesetz)) (j) Care recourse interdiction (k) Federal Act on a specific supplement due to the abolition of access to funds when housing people in inpatient care facilities (l) Federal Act on a specific supplement due to the abolition of access to funds when housing people in inpatient care facilities for 2019 and 2020, BGBl. I No 95/2019. BELGIUM (a) Health Care and Sickness Benefit Compulsory Insurance Act (Loi relative \u00e0 l'assurance obligatoire soins de sant\u00e9 et indemnit\u00e9s/Wet betreffende de verplichte verzekering voor geneeskundige verzorging en uitkeringen), coordinated on 14 July 1994 (b) Act of 27 February 1987 on allowances for persons with disabilities (Loi relative aux allocations aux personnes handicap\u00e9es/Wet betreffende de tegemoetkomingen aan gehandicapten). (c) Flemish social protection (Vlaamse sociale bescherming): Decree of the Flemish Parliament of 18 May 2018 on the organisation of Flemish social protection (Decreet houdende Vlaamse sociale bescherming/) and Orders of the Flemish government of 30 November 2018. (d) Walloon Code for Social Action and Health (Code wallon de l'Action sociale et de la Sant\u00e9), decretal part. Part 1, book IIIter, instituted by Decree of 8 November 2018 (e) Walloon Regulatory Code for Social Action and Health, part I/1 instituted by Walloon Government Decree of 21 December 2018 (f) Decree of 13 December 2018 on offers to elderly or dependent persons as well as on palliative care (Dekret \u00fcber die Angebote f\u00fcr Senioren und Personen mit Unterst\u00fctzungsbedarf sowie \u00fcber die Palliativpflege) (g) Decree of 4 June 2007 on psychiatric nursing homes (Dekret \u00fcber die psychiatrischen Pflegewohnheime) (h) Government Decree of 20 June 2017 on mobility aids (Erlass \u00fcber die Mobilit\u00e4tshilfen) (i) Decree of 13 December 2016 on the establishment of a German Community Office for self-determined life (Dekret zur Schaffung einer Dienststelle der Deutschsprachigen Gemeinschaft f\u00fcr selbstbestimmtes Leben) (j) Royal Decree of 5 March 1990 on the allowance for assistance to the elderly (Arr\u00eat\u00e9 royal du 5 mars 1990 relatif \u00e0 l'allocation pour l'aide aux personnes \u00e2g\u00e9es) (k) Government Decree of 19 December 2019 on transitional arrangements relating to the procedure for obtaining a prior authorization or an approval for the coverage or the sharing of costs of long-term rehabilitation abroad (Erlass der Regierung zur \u00fcbergansweisen Regelung des Verfahrens zur Erlangung einer Vorabgeehmigung oder Zustimmung zwecks Kosten\u00fcbernahme oder Kostenbeteiligung f\u00fcr eine Langzeitrehabilitation im Ausland). (l) Order of 21 December 2018 on Brussels health insurance bodies in the field of health care and assistance to people (Ordonnance du 21 d\u00e9cembre 2018 relative aux organismes assureurs bruxellois dans le domaine des soins de sant\u00e9 et de l'aide aux personnes) (m) Cooperation between federated entities: (n) Cooperation agreement of 31 December 2018 between the Flemish Community, the Walloon Region, the French Community Commission, the Joint Community Commission and the German-speaking Community concerning mobility aids (o) Cooperation agreement of 31 December 2018 between the Flemish Community, the Walloon Region, the French Community, the Joint Community Commission, the French Community Commission and the German-speaking Community concerning the financing of care when using care institutions located outside the limits of the federated entity. BULGARIA (a) Social Insurance Code (\u041a\u043e\u0434\u0435\u043a\u0441 \u0437\u0430 \u0441\u043e\u0446\u0438\u0430\u043b\u043d\u043e \u043e\u0441\u0438\u0433\u0443\u0440\u044f\u0432\u0430\u043d\u0435), 1999 title amended 2003. (b) Law on Social Assistance (\u0417\u0430\u043a\u043e\u043d \u0437\u0430 \u0441\u043e\u0446\u0438\u0430\u043b\u043d\u043e \u043f\u043e\u0434\u043f\u043e\u043c\u0430\u0433\u0430\u043d\u0435), 1998. (c) Regulation on the Implementation of the Law on Social Assistance (\u041f\u0440\u0430\u0432\u0438\u043b\u043d\u0438\u043a \u0437\u0430 \u043f\u0440\u0438\u043b\u0430\u0433\u0430\u043d\u0435 \u043d\u0430 \u0417\u0430\u043a\u043e\u043d\u0430 \u0437\u0430 \u0441\u043e\u0446\u0438\u0430\u043b\u043d\u043e \u043f\u043e\u0434\u043f\u043e\u043c\u0430\u0433\u0430\u043d\u0435), 1998. (d) Law on Integration of People with Disabilities 2019 (\u0417\u0430\u043a\u043e\u043d \u0437\u0430 \u0445\u043e\u0440\u0430\u0442\u0430 \u0441 \u0443\u0432\u0440\u0435\u0436\u0434\u0430\u043d\u0438\u044f), 2019. (e) Personal Assistance Act 2019 (\u0417\u0430\u043a\u043e\u043d \u0437\u0430 \u043b\u0438\u0447\u043d\u0430\u0442\u0430 \u043f\u043e\u043c\u043e\u0449) 2019 which entered into force on 1 September 2019. (f) Regulation on the Implementation of the Law on Integration of People with Disabilities (\u041f\u0440\u0430\u0432\u0438\u043b\u043d\u0438\u043a \u0437\u0430 \u043f\u0440\u0438\u043b\u0430\u0433\u0430\u043d\u0435 \u043d\u0430 \u0417\u0430\u043a\u043e\u043d\u0430 \u0437\u0430 \u0438\u043d\u0442\u0435\u0433\u0440\u0430\u0446\u0438\u044f \u043d\u0430 \u0445\u043e\u0440\u0430\u0442\u0430 \u0441 \u0443\u0432\u0440\u0435\u0436\u0434\u0430\u043d\u0438\u044f), 2004. (g) Ordinance on the medical expertise (\u041d\u0430\u0440\u0435\u0434\u0431\u0430 \u0437\u0430 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0430\u0442\u0430 \u0435\u043a\u0441\u043f\u0435\u0440\u0442\u0438\u0437\u0430) 2010. (h) Tariff of the Fees for Social Services Financed by the State Budget (\u0422\u0430\u0440\u0438\u0444\u0430 \u0437\u0430 \u0442\u0430\u043a\u0441\u0438\u0442\u0435 \u0437\u0430 \u0441\u043e\u0446\u0438\u0430\u043b\u043d\u0438 \u0443\u0441\u043b\u0443\u0433\u0438, \u0444\u0438\u043d\u0430\u043d\u0441\u0438\u0440\u0430\u043d\u0438 \u043e\u0442 \u0434\u044a\u0440\u0436\u0430\u0432\u043d\u0438\u044f \u0431\u044e\u0434\u0436\u0435\u0442), 2003. CROATIA (a) Social Welfare Act (Zakon o socijalnoj skrbi) of 2013, OJ no. 157/13, 152/14, 99/15, 52/16, 16/17, 130/17 and 98/19) (b) Foster Families Act (Zakon o udomiteljstvu) OJ no. 90/11 and 78/12, as amended. (c) Ordinance on minimum requirements for delivery of social services (Pravilnik o minimalnim uvjetima za pru\u017eanje socijalnih usluga) of 2014, OJ no 40/14 and 66/15. (d) Ordinance on participation and method of payment of beneficiaries in the maintenance costs of accommodation outside the family (Pravilnik o sudjelovanju i na\u010dinu pla\u0107anja korisnika I drugih obveznika uzdr\u017eavanja u tro\u0161kovima smje\u0161taja izvan vlastite obitelji) of 1998, OJ no. 112/98 and 05/02, as amended. (e) Ordinance on the content and manner of keeping records of individuals who are professionally engaged in social services delivery as a profession (Pravilnik o sadr\u017eaju I na\u010dinu vo\u0111enja evidencije fizi\u010dkih osoba koje profesionalno pru\u017eaju socijalne usluge) of 2015, OJ no. 66/15. CYPRUS (a) Social Welfare Services (\u03a5\u03c0\u03b7\u03c1\u03b5\u03c3\u03af\u03b5\u03c2 \u039a\u03bf\u03b9\u03bd\u03c9\u03bd\u03b9\u03ba\u03ae\u03c2 \u0395\u03c5\u03b7\u03bc\u03b5\u03c1\u03af\u03b1\u03c2): (b) The Guaranteed Minimum Income and in General the Social Benefits (Emergency Needs and Care Needs) Regulations and Decrees as they are amended or superseded. Homes for the Elderly and Disabled Persons Laws (\u039f\u03b9 \u03c0\u03b5\u03c1\u03af \u03a3\u03c4\u03b5\u03b3\u03ce\u03bd \u03b3\u03b9\u03b1 \u0397\u03bb\u03b9\u03ba\u03b9\u03c9\u03bc\u03ad\u03bd\u03bf\u03c5\u03c2 \u03ba\u03b1\u03b9 \u0391\u03bd\u03b1\u03c0\u03ae\u03c1\u03bf\u03c5\u03c2 \u039d\u03cc\u03bc\u03bf\u03b9) of 1991 - 2011.[L. 222/91 and L. 65(I)/2011]. (c) Adult Day-Care Centres Laws (\u039f\u03b9 \u03c0\u03b5\u03c1\u03af \u039a\u03ad\u03bd\u03c4\u03c1\u03c9\u03bd \u0395\u03bd\u03b7\u03bb\u03af\u03ba\u03c9\u03bd \u039d\u03cc\u03bc\u03bf\u03b9)(L. 38(\u0399)/1997 and L.64(\u0399)/2011). (d) State Aid Scheme, under the Regulation 360/2012 for the provision of services of general economic interest (De minimis) [\u03a3\u03c7\u03ad\u03b4\u03b9\u03bf \u039a\u03c1\u03b1\u03c4\u03b9\u03ba\u03ce\u03bd \u0395\u03bd\u03b9\u03c3\u03c7\u03cd\u03c3\u03b5\u03c9\u03bd \u2018\u0397\u03c3\u03c3\u03bf\u03bd\u03bf\u03c2 \u03a3\u03b7\u03bc\u03b1\u03c3\u03af\u03b1\u03c2, \u03b2\u03b1\u03c3\u03b7 \u03c4\u03bf\u03c5 \u039a\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03bc\u03bf\u03cd 360/2012 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03c0\u03b1\u03c1\u03bf\u03c7\u03ae \u03c5\u03c0\u03b7\u03c1\u03b5\u03c3\u03b9\u03ce\u03bd \u03b3\u03b5\u03bd\u03b9\u03ba\u03bf\u03cd \u03bf\u03b9\u03ba\u03bf\u03bd\u03bf\u03bc\u03b9\u03ba\u03bf\u03cd \u03c3\u03c5\u03bc\u03c6\u03ad\u03c1\u03bf\u03bd\u03c4\u03bf\u03c2]. (e) Welfare Benefits Administration Service (\u03a5\u03c0\u03b7\u03c1\u03b5\u03c3\u03af\u03b1 \u0394\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u0395\u03c0\u03b9\u03b4\u03bf\u03bc\u03ac\u03c4\u03c9\u03bd \u03a0\u03c1\u03cc\u03bd\u03bf\u03b9\u03b1\u03c2): (f) The Guaranteed Minimum Income and generally for Welfare Benefits Law of 2014 as it is amended or superseded. (g) The Guaranteed Minimum Income and generally for Welfare Benefits Regulations and Decrees as they are amended or superseded. CZECH REPUBLIC (a) Act. No. 108/2006 on social services (Z\u00e1kon o soci\u00e1ln\u00edch slu\u017eb\u00e1ch). (b) Act No. 372/2011 on Health Services (Z\u00e1kon o zdravotn\u00edch slu\u017eb\u00e1ch). (c) Act No. 48/1997 on Public Health Insurance (Z\u00e1kon o ve\u0159ejn\u00e9m zdravotn\u00edm poji\u0161t\u011bn\u00ed). DENMARK (a) Consolidated Act No 988 of 17 August 2017 on Social Services (om social service). (b) Consolidated Act No 119 of 1 February 2019 on Social Housing (om almene boliger). ESTONIA Social Welfare Act (Sotsiaalhoolekande seadus) 2016. FINLAND (a) Services and Assistance for the Disabled Act (Laki vammaisuuden perusteella j\u00e4rjestett\u00e4vist\u00e4 palveluista ja tukitoimista) of 3 April 1987. (b) Act on Supporting the Functional Capacity of the Ageing Population and on Social and Health Care Services for Older People (Laki ik\u00e4\u00e4ntyneen v\u00e4est\u00f6n toimintakyvyn tukemisesta sek\u00e4 i\u00e4kk\u00e4iden sosiaali- ja terveyspalveluista) of 28 December 2012. (c) Social Welfare Act (Sosiaalihuoltolaki) of 30 December 2014. (d) Health Care Act (Terveydenhuoltolaki) of 30 December 2010. (e) Primary Health Care Act (Kansanterveyslaki) of 28 January 1972. (f) Act on Informal Care Support (Laki omaishoidon tuesta) of 2 December 2005. (g) Family Care Act (Perhehoitolaki) of 20 March 2015. FRANCE (a) Supplement for a third party (majoration pour tierce personne, MTP): Articles L. 341-4 and L. 355-1 of the Social Security Code (Code de la s\u00e9curit\u00e9 sociale). (b) Supplementary benefit for recourse to a third party (prestation compl\u00e9mentaire pour recours \u00e0 tierce personne): Article L. 434-2 of the Social Security Code. (c) Special education supplement for a disabled child (compl\u00e9ment d'allocation d'\u00e9ducation de l'enfant handicap\u00e9): Article L. 541-1 of the Social Security Code. (d) Disability compensation allowance (prestation de compensation du handicap, PCH): Articles L. 245-1 to L. 245-14 of the Social action and Family Code (Code de l'action sociale et des familles). (e) Allowance for loss of autonomy (allocation personnalis\u00e9e d'autonomie, APA): Articles L. 232-1 to L. 232-28 of the Social action and Family Code (Code de l'action sociale et des familles). GERMANY (a) Long-term care insurance (Pflegeversicherung): (b) Social long-term care insurance for persons insured under statutory sickness insurance and private compulsory long-term care insurance for persons insured under private sickness insurance: Social CodeSozialgesetzbuch, Book XI (SGB XI), last amended by Article 2 of the Act of 21 December 2019 (BGBl. I p. 2913). GREECE (a) Law No. 1140/1981, as amended. (b) Legislative Decree No. 162/73 and Joint Ministerial Decision No. \u03a04\u03b2/5814/1997. (c) Ministerial Decision No. \u03a01\u03b3/\u0391\u0393\u03a0/\u03bf\u03b9\u03ba.14963 of 9 October 2001. (d) Law No. 4025/2011. (e) Law No. 4109/2013. (f) Law No. 4199/2013 art. 127. (g) Law No. 4368/2016 art. 334. (h) Law No. 4483/2017 art. 153. (i) Law No. 498/1-11-2018, art. 28, 30 and 31, for the \"Unified Health Benefits Regulation\" of the National Service Provider Organization Health (EOPYY). HUNGARY (a) Long-term care services providing personal social care (social services): (b) Act III of 1993 on Social Administration and Social Assistance (t\u00f6rv\u00e9ny a szoci\u00e1lis igazgat\u00e1sr\u00f3l \u00e9s szoci\u00e1lis ell\u00e1t\u00e1sokr\u00f3l) supplemented by Government and Ministerial decrees. IRELAND (a) Health Act 1970 (No. 1 of 1970). (b) Nursing Homes Support Scheme Act 2009 (No. 15 of 2009). (c) Social Welfare Consolidation Act 2005: (d) Constant Attendance Allowance; (e) Carer's Benefit; (f) Carer's Allowance; (g) Carer's Support Grant; (h) Domiciliary Care Allowance. ITALY (a) Law No. 118 of 30 March 1971 on civilian invalidity benefits (Legge 30 Marzo 1971, n. 118 - Conversione in Legge del D.L. 30 gennaio 1971, n. 5 e nuove norme in favore dei mutilati ed invalidi civili). (b) Law No. 18 of 11 February 1980 on Constant attendance allowance (Legge 11 Febbraio 1980, n. 18 - Indennit\u00e0 di accompagnamento agli invalidi civili totalmente inabili). (c) Law No. 104 of 5 February 1992, Article 33 (Framework law on disability) (Legge 5 Febbraio 1992, n. 104 - Legge-quadro per l'assistenza, l'integrazione sociale e i diritti delle persone handicappate). (d) Legislative Decree No. 112 of 31 March 1998 on the transfer of legislative tasks and administrative competences from the State to the Regions and local entities (Decreto Legislativo 31 Marzo 1998, n. 112 - Conferimento di funzioni e compiti amministrativi dello Stato alle regioni ed agli enti locali, in attuazione del capo I della Legge 15 Marzo 1997, n. 59). (e) Regulation (CE) 883/04 on social security coordination of the European Parliament and Council (Regolamento (CE) 883 del 29 aprile 2004 del Parlamento Europeo e del Consiglio, relativo al coordinamento dei sistemi di sicurezza sociale - SNCB \u2013 art 70 and Annex X). (f) Law No. 183 of 4 November 2010, Article 24, modifying the rules regarding the permits for the assistance to disabled persons in difficult situations (Legge n. 183 del 4 Novembre 2010, art. 24 - Modifiche alla disciplina in materia di permessi per l'assistenza a portatori di handicap in situazione di gravit\u00e0). (g) Law No. 147 of 27 December 2013 containing provisions for drawing up the annual and pluri-annual budget of the State \u2013 Stability Law 2014 (Disposizioni per la formazione del bilancio annuale e pluriennale dello Stato - Legge di stabilit\u00e0 2014). LATVIA (a) Law on Social Services and Social Assistance (Soci\u0101lo pakalpojumu un soci\u0101l\u0101s pal\u012bdz\u012bbas likums) 31/10/2002. (b) Medical Treatment Law (\u0100rstniec\u012bbas likums) 12/06/1997. (c) Law on Patient Rights (Pacientu ties\u012bbu likums) 30/12/2009 (d) Regulations of the Cabinet of Ministers No. 555 on Health care organisation and payment procedure (Ministru kabineta 2018. gada 28.augusta noteikumi Nr.555 \u201cVesel\u012bbas apr\u016bpes pakalpojumu organiz\u0113\u0161anas un samaksas k\u0101rt\u012bba\u201d) 28/08/2018. (e) Regulations of the Cabinet of Ministers No. 275 on Procedures for Payment of Social Care and Social Rehabilitation Services and the Procedures for Covering Service Costs from a Local Government Budget (Ministru kabineta 2003.gada 27.maija noteikumi Nr.275 \u201eSoci\u0101l\u0101s apr\u016bpes un soci\u0101l\u0101s rehabilit\u0101cijas pakalpojumu samaksas k\u0101rt\u012bba un k\u0101rt\u012bba, k\u0101d\u0101 pakalpojuma izmaksas tiek segtas no pa\u0161vald\u012bbas bud\u017eeta\u201d) 27/05/2003. (f) Regulations of the Cabinet of Ministers No. 138 on Receiving of Social Services and Social Assistance (Ministru kabineta 2019.gada 2.apr\u012b\u013ca noteikumi Nr 138 \"Noteiku mi par soci\u0101lo pakalpojumu un soci\u0101l\u0101s pal\u012bdz\u012bbas sa\u0146em\u0161anu\") 02/04/2019. LITHUANIA (a) Law on Target compensations (Tikslini\u0173 kompensacij\u0173 \u012fstatymas) of 29 June 2016 (No. XII-2507). (b) Law on Social Services (Socialini\u0173 paslaug\u0173 \u012fstatymas) of 19 January 2006 (No. X-493). (c) Law on Health Insurance (Sveikatos draudimo \u012fstatymas) of 21 May 1996 (No I-1343). (d) Law on Healthcare system (Sveikatos sistemos \u012fstatymas) of 19 July 1994 (No I-552). (e) Law on Health Care Institutions (Sveikatos prie\u017ei\u016bros \u012fstaig\u0173 \u012fstatymas) of 6 June 1996 (No. I-1367). LUXEMBOURG Law of 19 June 1998 introducing the dependency insurance, amended by the Law of 23 December 2005 and the Law of 29 August 2017. MALTA (a) Social Security Act (Att dwar is-Sigurta' Socjali) (Cap. 318). (b) Subsidiary Legislation 318.19: State-Owned Institutions and Hostels Rates Regulations (Regolamenti dwar it-Trasferiment ta' Fondi g\u0127al Hostels Statali Indikati). (c) Subsidiary Legislation 318.17: Transfer of Funds (Government Financed Beds) Regulations (Regolamenti dwar it-Trasferiment ta' Fondi g\u0127al Sodod Iffinanzjati mill-Gvern). (d) Subsidiary Legislation 318.13: State Financed Residential Services Rates Regulations (Regolamenti dwar Rati g\u0127al Servizzi Residenzjali Finanzjali mill-Istat). THE NETHERLANDS Long term care act (Wet langdurige zorg (WLZ)), Law of 3 December 2014. POLAND (a) Law on Health Care Services financed from Public Means (Ustawa o \u015bwiadczeniach opieki zdrowotnej finansowanych ze \u015brodk\u00f3w publicznych) of 27 August 2004. (b) Law on Social Assistance (Ustawa o pomocy spo\u0142ecznej) of 12 March 2004. (c) Law on Family Benefits (Ustawa o \u015bwiadczeniach rodzinnych) of 28 November 2003. (d) Law on Social Pension (Ustawa o rencie socjalnej) of 27 June 2003. (e) Law on Social Insurance Fund Pensions (Ustawa o emeryturach i rentach z Funduszu Ubezpiecze\u0144 Spo\u0142ecznych) of 17 December 1998. (f) Law on Vocational and Social Rehabilitation and Employment of Disabled Persons (Ustawa o rehabilitacji zawodowej i spo\u0142ecznej oraz zatrudnianiu os\u00f3b niepe\u0142nosprawnych) of 27 August 1997. (g) Law on support for pregnant women and their families \"For life\" (Ustawa o wsparciu kobiet w ci\u0105\u017cy i rodzin \u201cZa \u017cyciem\u201d) of 4 November 2016. (h) Law on supplementary benefit for persons unable to live independently (Ustawa o \u015bwiadczeniu uzupe\u0142niaj\u0105cym dla os\u00f3b niezdolnych do samodzielnej egzystencji) of 31 July 2019. PORTUGAL (a) Social insurance and guaranteeing sufficient resources: (b) Statutory Decree 265/99 of 14 July 1999 on the long-term care supplement (complemento por depend\u00eancia), as amended on several occasions. (c) Act 90/2009 of 31 August 2009 on the special protection system in case of disability (regime especial de prote\u00e7\u00e3o na invalidez), re-published in consolidated version by Statutory Decree 246/2015 of 20 October 2015, amended. (d) Social security system and National Health Service: (e) Statutory Decree 101/06 of 6 June 2006 on the National network of integrated continuing care (rede de cuidados continuados integrados), re-published in a consolidated version in Statutory Decree 136/2015 of 28 July 2015. (f) Decree-Law n\u00b0 8/2010 of 28 January 2010, amended and republished by Decree-Law n\u00b0 22/2011 of 10 February 2011 on the creation of units and teams for integrated continuous care in mental health (unidades e equipas de cuidados continuados integrados de sa\u00fade mental). (g) Decree n\u00b0 343/.2015 of 12 October 2015 on standards governing hospital and ambulatory paediatric care as well as the discharge management teams and the paediatric care teams within the framework of the national network of long-term integrated care (condi\u00e7\u00f5es de instala\u00e7\u00e3o e funcionamento das unidades de internamento de cuidados integrados pedi\u00e1tricos e de ambulat\u00f3rio pedi\u00e1tricas, bem como as condi\u00e7\u00f5es a que devem obedecer as equipas de gest\u00e3o de altas e as equipas de cuidados continuados integrados destinadas a cuidados pedi\u00e1tricos da Rede Nacional de Cuidados Continuados Integrados). (h) Law n\u00b0 6/2009 of 6 September on the status of informal carer (Estatuto do cuidador informal). ROMANIA (a) Law 17 of 6 March 2000 on Social Assistance of Senior Persons (Legea privind asisten\u021ba social\u0103 a persoanelor v\u00e2rstnice), with subsequent amendments. (b) Law 448 of 6 December 2006 on Protection and Promotion of the Rights of Persons with Disability (Legea privind protec\u021bia \u0219i promovarea drepturilor persoanelor cu handicap), with subsequent amendments. (c) Social Assistance Law (Legea asisten\u021bei sociale) No. 292 of 20 December 2011. SLOVAKIA (a) Law on Social Services (Z\u00e1kon o soci\u00e1lnych slu\u017eb\u00e1ch) No. 448/2008. (b) Law on Financial Benefits for Compensation of Disabled Persons (Z\u00e1kon o pe\u0148a\u017en\u00fdch pr\u00edspevkoch na kompenz\u00e1ciu \u0165a\u017ek\u00e9ho zdravotn\u00e9ho postihnutia) No. 447/2008. (c) Law on Health Care and Services Related to Health Care (Z\u00e1kon o zdravotnej starostlivosti a slu\u017eb\u00e1ch s\u00favisiacich s poskytovan\u00edm zdravotnej starostlivosti) No. 576/2004. (d) Law on Health Care Providers, Medical Workers and Professional Medical Associations (Z\u00e1kon o poskytovate\u013eoch zdravotnej starostlivosti, zdravotn\u00edckych pracovn\u00edkoch a stavovsk\u00fdch organiz\u00e1ci\u00e1ch v zdravotn\u00edctve) No. 578/2004. (e) Law on Subsistence Minimum (Z\u00e1kon o \u017eivotnom minime) No. 601/2003. (f) Law on Family (Z\u00e1kon o rodine) No. 36/2005 (g) Law on Social and legal protection of children and social guardianship (Z\u00e1kon o soci\u00e1lno-pr\u00e1vnej ochrane det\u00ed a soci\u00e1lnej kuratele) No. 305/2005 (h) Law on Social Work (Z\u00e1kon o soci\u00e1lnej pr\u00e1ci) No. 219/2014. SLOVENIA No specific law related to long-term care. Long-term care benefits are included in the following acts: (a) Pension and Disability Insurance Act (Zakon o pokojninskem in invalidskem zavarovanju) (Official Gazette of the Republic of Slovenia, no. 96/2012, and subsequent amendments). (b) Financial Social Assistance Act (Zakon o socialno vartsvenih prejemkih) (Official Gazette of the Republic of Slovenia, no. 61/2010, and subsequent amendments). (c) Exercise of Rights to Public Funds Act (Zakon o uveljavljanju pravic iz javnih sredstev) (Official Gazette of the Republic of Slovenia, no. 62/2010, and subsequent amendments). (d) Social Protection Act (Zakon o socialnem varstvu) (Official Gazette of the Republic of Slovenia, no. 3/2004 \u2013 official consolidated text, and subsequent amendments). (e) Parental Care and Family Benefits Act (Zakon o star\u0161evskem varstvu in dru\u017einskih prejemkih) (Official Gazette of the Republic of Slovenia, no. 110/2006 \u2013 official consolidated text, and subsequent amendments). (f) Mentally and Physically Handicapped Persons Act (Zakon o dru\u017ebenem varstvu du\u0161evno in telesno prizadetih oseb) (Official Gazette of the Republic of Slovenia, no. 41/83, and subsequent amendments). (g) Health Care and Health Insurance Act (Zakon o zdravstvenem varstvu in zdravstvenem zavarovanju) (Official Gazette of the Republic of Slovenia, no. 72/2006 \u2013 official consolidated text, and subsequent amendments). (h) War Veterans Act (Zakon o vojnih veteranih) (Official Gazette of the Republic of Slovenia, no 59/06 official consolidated text, and subsequent amendments) (i) War Disability Act (Zakon o vojnih invalidih) (Official Gazette of the Republic of Slovenia, no 63/59 official consolidated text, and subsequent amendments) (j) Fiscal Balance Act (Zakon za uravnote\u017eenje javnih finance (ZUJF)) (Official Gazette of the Republic of Slovenia, no. 40/2012, and subsequent amendments). (k) Act Regulating Adjustments of Transfers to Individuals and Households in the Republic of Slovenia (Zakon o usklajevanju transferjev posameznikom in gospodinjstvom v Republiki Sloveniji) (Official Gazette of the Republic of Slovenia, no. 114/2006 \u2013 official consolidated text, and subsequent amendments). SPAIN (a) Law No. 39/2006 on the Promotion of Personal Autonomy and Assistance to persons in situations of dependence of 14 December 2006, as amended. (b) Ministerial Order of 15 April 1969. (c) Royal Decree No. 1300/95 of 21 July 1995, as amended. (d) Royal Decree No. 1647/97 of 31 October 1997, as amended. SWEDEN (a) Social Services Act (Socialtj\u00e4nstlagen (2001:453)) of 2001. (b) The Health Care Act (H\u00e4lso- och sjukv\u00e5rdslag (2017:30)) of 2017. PART 3 PAYMENTS WHICH ARE CONNECTED TO A BRANCH OF SOCIAL SECURITY LISTED IN ARTICLE SSC.3(1) OF THIS PROTOCOL AND WHICH ARE PAID TO MEET EXPENSES FOR HEATING IN COLD WEATHER (Point (f) of Article SSC.3(4) of this Protocol) (i) UNITED KINGDOM Winter Fuel Payment (Social Security Contributions and Benefits Act 1992, Social Fund Winter Fuel Payment Regulations 2000, Social Security Contributions and Benefits (Northern Ireland) Act 1992 and Social Fund Winter Fuel Payment Regulations (Northern Ireland) 2000). (ii) MEMBER STATES DENMARK (a) Act on Social and state pensions, LBK no. 983 of 23/09/2019 (b) Regulations on social and state pensions, BEK no. 1602 of 27/12/2019. ANNEX SSC-2 RESTRICTION OF RIGHTS TO BENEFITS IN KIND FOR MEMBERS OF THE FAMILY OF A FRONTIER WORKER (referred to in Article SSC.16(2) of this Protocol) CROATIA DENMARK IRELAND FINLAND SWEDEN UNITED KINGDOM ANNEX SSC-3 MORE RIGHTS FOR PENSIONERS RETURNING TO THE COMPETENT STATE (Article SSC.25(2) of this Protocol) AUSTRIA BELGIUM BULGARIA CYPRUS CZECH REPUBLIC FRANCE GERMANY GREECE HUNGARY LUXEMBOURG THE NETHERLANDS POLAND SLOVENIA SPAIN SWEDEN ANNEX SSC-4 CASES IN WHICH THE PRO RATA CALCULATION SHALL BE WAIVED OR SHALL NOT APPLY (Article SSC.47(4) and (5) of this Protocol) PART 1 CASES IN WHICH THE PRO RATA CALCULATION SHALL BE WAIVED PURSUANT TO ARTICLE SSC.47(4) AUSTRIA (a) All applications for benefits under the Federal Act of 9 September 1955 on General Social Insurance \u2013 ASVG, the Federal Act of 11 October 1978 on social insurance for self-employed persons engaged in trade and commerce \u2013 GSVG, the Federal Act of 11 October 1978 on social insurance for self-employed farmers \u2013 BSVG and the Federal Act of 30 November 1978 on social insurance for the self-employed in the liberal professions (FSVG); (b) All applications for survivors' pensions based on a pension account pursuant to the General Pensions Act (APG) of 18 November 2004, with the exception of cases under Part 2; (c) All applications for survivors' pensions of the Austrian Provincial Chambers of Physicians (Landes\u00e4rztekammer) based on basic provision (basic and any supplementary benefit, or basic pension); (d) All applications for survivors' support from the pension fund of the Austrian Chamber of Veterinary Surgeons; (e) All applications for benefits from widows and orphans pensions according to the statutes of the welfare institutions of the Austrian bar associations, Part A; (f) All applications for benefits under the Notary Insurance Act of 3 February 1972 \u2013 NVG 1972. CYPRUS All applications for old age, widow's and widower's pensions. DENMARK All applications for pensions referred to in the law on social pensions, except for pensions mentioned in Annex SSC-5 to this Protocol. IRELAND All applications for state pension (transition), state pension (contributory), widow's (contributory) pension and widower's (contributory) pension. LATVIA All applications for survivor's pensions (Law on State pensions of 1 January 1996; Law on State funded pensions of 1 July 2001). LITHUANIA All applications for State social insurance survivor's pensions calculated on the basis of the basic amount of survivor's pension (Law on State Social Insurance Pensions). NETHERLANDS All applications for old-age pensions under the law on general old-age insurance (AOW). POLAND All applications for old-age under the defined benefits scheme and survivors' pensions, except for the cases where the totalised periods of insurance completed under the legislation of more than one country are equal to or longer than 20 years for women and 25 years for men but the national periods of insurance are inferior to these limits (and not less than 15 years for women and 20 years for men), and the calculation is made under Articles 27 and 28 of the Act of 17 December 1998 (O.J. 2015, item 748). PORTUGAL All applications for old-age and survivors' pension claims, except for the cases where the totalised periods of insurance completed under the legislation of more than one country are equal to or longer than 21 calendar years but the national periods of insurance are equal or inferior to 20 years, and the calculation is made under Articles 32 and 33 of Decree-Law No 187/2007 of 10 May 2007. SLOVAKIA (a) All applications for survivors' pension (widow's pension, widower's and orphan's pension) calculated according to the legislation in force before 1 January 2004, the amount of which is derived from a pension formerly paid to the deceased; (b) All applications for pensions calculated pursuant to Act No 461/2003 Coll. on social security as amended. SWEDEN (a) Applications for an old-age pension in the form of a guaranteed pension (Chapters 66 and 67 of the Social Insurance Code). (b) Applications for an old-age pension in the form of a supplementary pension (Chapter 63 of the Social Insurance Code). UNITED KINGDOM All applications for retirement pension, state pension pursuant to Part 1 of the Pensions Act 2014, widows' and bereavement benefits, with the exception of those for which during a tax year beginning on or after 6 April 1975: (i) the party concerned had completed periods of insurance, employment or residence under the legislation of the United Kingdom and a Member State; and one (or more) of the tax years was not considered a qualifying year within the meaning of the legislation of the United Kingdom; (ii) the periods of insurance completed under the legislation in force in the United Kingdom for the periods prior to 5 July 1948 would be taken into account for the purposes of point (b) of Article SSC.47(1) of this Protocol by application of the periods of insurance, employment or residence under the legislation of a Member State. All applications for additional pension pursuant to the Social Security Contributions and Benefits Act 1992, section 44, and the Social Security Contributions and Benefits (Northern Ireland) Act 1992, section 44. PART 2 CASES IN WHICH ARTICLE SSC.47(5) APPLIES AUSTRIA (a) Old-age pensions and survivor's pensions derived thereof based on a pension account pursuant to the General Pensions Act (APG) of 18 November 2004; (b) Compulsory allowances under Article 41 of the Federal Law of 28 December 2001, BGBl I Nr. 154 on the general salary fund of Austrian pharmacists (Pharmazeutische Gehaltskasse f\u00fcr \u00d6sterreich); (c) Retirement and early retirement pensions of the Austrian Provincial Chambers of Physicians based on basic provision (basic and any supplementary benefit, or basic pension), and all pension benefits of the Austrian Provincial Chambers of Physicians based on additional provision (additional or individual pension); (d) Old-age support from the pension fund of the Austrian Chamber of Veterinary Surgeons; (e) Benefits according to the statutes of the welfare institutions of the Austrian bar associations, Parts A and B, with the exception of applications for benefits from widows' and orphans' pensions according to the statutes of the welfare institutions of the Austrian bar associations, Part A; (f) Benefits by the welfare institutions of the Federal Chamber of Architects and Consulting Engineers under the Austrian Civil Engineers' Chamber Act (Ziviltechnikerkammergesetz) 1993 and the statutes of the welfare institutions, with the exception of benefits on grounds of survivors' benefits deriving from the last-named benefits; (g) Benefits according to the statute of the welfare institution of the Federal Chamber of Professional Accountants and Tax Advisors under the Austrian Professional Accountants and Tax Advisors' Act (Wirtschaftstreuhandberufsgesetz). BULGARIA Old age pensions from the Supplementary Compulsory Pension Insurance, under Part II, Title II, of the Social Insurance Code. CROATIA Pensions from the compulsory insurance scheme based on the individual capitalised savings according to the Compulsory and Voluntary Pension Funds Act (OG 49/99, as amended) and the Act on Pension Insurance Companies and Payment of Pensions Based on Individual Capitalised Savings (OG 106/99, as amended), except in the cases provided by Articles 47 and 48 of the Compulsory and Voluntary Pension Funds Act and survivor's pension). CZECH REPUBLIC Pensions paid from the Second Pillar scheme established by Act No 426/2011 Coll., on pension savings. DENMARK (a) Personal pensions; (b) Benefits in the event of death (accrued based on contributions to Arbejdsmarkedets Till\u00e6gspension related to the time before 1 January 2002); (c) Benefits in the event of death (accrued based on contributions to Arbejdsmarkedets Till\u00e6gspension related to the time after 1 January 2002) referred to in the Consolidated Act on Labour Market Supplementary Pension (Arbejdsmarkedets Till\u00e6gspension) 942:2009. ESTONIA Mandatory funded old-age pension scheme. FRANCE Basic or supplementary schemes in which old-age benefits are calculated on the basis of retirement points. HUNGARY Pension benefits based on membership of private pension funds. LATVIA Old-age pensions (Law on State pensions of 1 January 1996; Law on State funded pensions of 1 July 2001). POLAND Old-age pensions under the defined contribution scheme. PORTUGAL Supplementary pensions granted pursuant to Decree-Law No 26/2008 of 22 February 2008 (public capitalisation scheme). SLOVAKIA Mandatory old-age pension saving. SLOVENIA Pension from compulsory supplementary pension insurance. SWEDEN Old-age pension in the form of an income pension and a premium pension (Chapters 62 and 64 of the Social Insurance Code). UNITED KINGDOM Graduated retirement benefits paid pursuant to the National Insurance Act 1965, sections 36 and 37, and the National Insurance Act (Northern Ireland) 1966, sections 35 and 36. ANNEX SSC-5 BENEFITS AND AGREEMENTS WHICH ALLOW THE APPLICATION OF ARTICLE SSC.49 I. Benefits referred to in point (a) of Article SSC.49(2) of this Protocol, the amount of which is independent of the length of periods of insurance or residence completed DENMARK The full Danish national old-age pension acquired after 10 years' residence by persons who will have been awarded a pension by 1 October 1989 FINLAND National pensions and spouse's pensions determined according to the transitional rules and awarded prior to 1 January 1994 (Act on Enforcement of the National Pensions Act, 569/2007) The additional amount of child's pension when calculating independent benefit according to the National Pension Act (the National Pension Act, 568/2007) FRANCE Widower's or widow's invalidity pension under the general social security system or under the agricultural workers scheme where it is calculated on the basis of the deceased spouse's invalidity pension settled in accordance with point (a) of Article SSC.47(1). GREECE Benefits under Law No 4169/1961 relating to the agricultural insurance scheme (OGA) NETHERLANDS General Surviving Relatives Act of 21 December 1995 (ANW) The Work and Income according to Labour Capacity Act of 10 November 2005 (WIA) SPAIN Survivors' pensions granted under the general and special schemes, with the exception of the Special Scheme for Civil Servants SWEDEN Income-related sickness compensation and income-related activity compensation (Chapter 34 of the Social Insurance Code) Guaranteed pension and guaranteed compensation which replaced the full state pensions provided under the legislation on the state pension which applied before 1 January 1993, and the full state pension awarded under the transitional rules of the legislation applying from that date II. Benefits referred to in point (b) of Article SSC.49(2) of this Protocol, the amount of which is determined by reference to a credited period deemed to have been completed between the date on which the risk materialised and a later date FINLAND Employment pensions for which account is taken of future periods according to the national legislation GERMANY Survivors' pensions, for which account is taken of a supplementary period Old-age pensions, for which account is taken of a supplementary period already acquired ITALY Italian pensions for total incapacity for work (inabilit\u00e0) LATVIA Survivors' pension calculated on the basis of assumed insurance periods (Article 23(8) of the Law on State Pensions of 1 January 1996) LITHUANIA (a) State social insurance work incapacity pensions, paid under the Law on State Social Insurance Pensions (b) State social insurance survivors' and orphans' pensions, calculated on the basis of the work incapacity pension of the deceased under the Law on State Social Insurance Pensions LUXEMBOURG Survivors' pensions SLOVAKIA Slovak survivors' pension derived from the invalidity pension. SPAIN The pensions for retirement under the Special Scheme for Civil Servants due under Title I of the consolidated text of the Law on State Pensioners if at the time of materialisation of the risk the beneficiary was an active civil servant or treated as such; death and survivors' (widows'/widowers', orphans' and parents') pensions due under Title I of the consolidated text of the Law on State Pensioners if at the time of death the civil servant was active or treated as such SWEDEN Sickness compensation and activity compensation in the form of guarantee compensation (Chapter 35 of the Social Insurance Code) Survivors' pension calculated on the basis of credited insurance periods (Chapters 76-85 of the Social Insurance Code) III. Agreements referred to in point (b)(i) of Article SSC.49(2) of this Protocol intended to prevent the same credited period being taken into account two or more times: The Social Security Agreement of 28 April 1997 between the Republic of Finland and the Federal Republic of Germany The Social Security Agreement of 10 November 2000 between the Republic of Finland and the Grand Duchy of Luxembourg Nordic Convention on social security of 18 August 2003. ANNEX SSC-6 SPECIAL PROVISIONS FOR THE APPLICATION OF THE LEGISLATION OF THE MEMBER STATES AND OF THE UNITED KINGDOM (Article SSC.3(2), Article SSC.51(1) and Article SSC.66) AUSTRIA 1. For the purpose of acquiring periods in the pension insurance, attendance at a school or comparable educational establishment in another State shall be regarded as equivalent to attendance at a school or educational establishment pursuant to Articles 227(1)(1) and 228(1)(3) of the Allgemeines Sozialversicherungsgesetz (ASVG) (General Social Security Act), Article 116(7) of the Gewerbliches Sozialversicherungsgesetz (GSVG) (Federal Act on Social Insurance for Persons engaged in Trade and Commerce) and Article 107(7) of the Bauern-Sozialversicherungsgesetz (BSVG) (Social Security Act for Farmers), when the person concerned was subject at some time to Austrian legislation on the grounds that he pursued an activity as an employed or self-employed person, and the special contributions provided for under Article 227(3) of the ASVG, Article 116(9) of the GSVG and Article 107(9) of the BSGV for the purchase of such periods of education, are paid. 2. For the calculation of the pro rata benefit referred to in point (b) of Article SSC.47(1) of this Protocol, special increments for contributions for supplementary insurance and the miners' supplementary benefit under Austrian legislation shall be disregarded. In those cases the pro rata benefit calculated without those contributions shall, if appropriate, be increased by unreduced special increments for contributions for supplementary insurance and the miners' supplementary benefit. 3. Where pursuant to Article SSC.7 of this Protocol substitute periods under an Austrian pension insurance scheme have been completed but cannot form a basis for calculation pursuant to Articles 238 and 239 of the ASVG, Articles 122 and 123 of the GSVG and Articles 113 and 114 of the BSVG, the calculation basis for periods of childcare pursuant to Article 239 of the ASVG, Article 123 of the GSVG and Article 114 of the BSVG shall be used. BULGARIA Article 33(1) of the Bulgarian Health Insurance Act applies to all persons for whom Bulgaria is the competent Member State under Chapter 1 of Title III of this Protocol. CYPRUS For the purpose of applying the provisions of Articles SSC.7, SSC.46 and SSC.56 of this Protocol, for any period commencing on or after 6 October 1980, a week of insurance under the legislation of the Republic of Cyprus is determined by dividing the total insurable earnings for the relevant period by the weekly amount of the basic insurable earnings applicable in the relevant contribution year, provided that the number of weeks so determined shall not exceed the number of calendar weeks in the relevant period. CZECH REPUBLIC For the purposes of defining members of the family in accordance with point (s) of Article SSC.1 of this Protocol, \"spouse\" includes registered partners as defined in the Czech act no. 115/2006 Coll., on registered partnership. DENMARK 1. (a) For the purpose of calculating the pension under the \"lov om social pension\" (Social Pension Act), periods of activity as an employed or self-employed person completed under Danish legislation by a frontier worker or a worker who has gone to Denmark to do work of a seasonal nature are regarded as periods of residence completed in Denmark by the surviving spouse in so far as, during those periods, the surviving spouse was linked to the abovementioned worker by marriage without separation from bed and board or de facto separation on grounds of incompatibility, and provided that, during those periods, the spouse resided in the territory of another State. For the purposes of this point, \"work of a seasonal nature\" means work which, being dependent on the succession of the seasons, automatically recurs each year. (b) For the purpose of calculating the pension under the \"lov om social pension\" (Social Pension Act), periods of activity as an employed or self-employed person completed under Danish legislation before 1 January 1984 by a person to whom point (a) does not apply shall be regarded as periods of residence completed in Denmark by the surviving spouse, in so far as, during those periods, the surviving spouse was linked to that person by marriage without separation from bed and board or de facto separation on grounds of incompatibility, and provided that, during those periods, the spouse resided in the territory of another State. (c) Periods to be taken into account under points (a) and (b) shall not be taken into consideration if they coincide with the periods taken into account for the calculation of the pension due to the person concerned under the legislation on compulsory insurance of another State, or with the periods during which the person concerned received a pension under such legislation. Those periods shall, however, be taken into consideration if the annual amount of the said pension is less than half the basic amount of the social pension. 2. (a) Notwithstanding the provisions of Article SSC.7 of this Protocol, persons who have not been gainfully employed in one or more States are entitled to a Danish social pension only if they have been, or have previously been, permanent residents of Denmark for at least 3 years, subject to the age limits prescribed by Danish legislation. Subject to Article SSC.5 of this Protocol, Article SSC.8 of this Protocol does not apply to a Danish social pension to which entitlement has been acquired by such persons. (b) The provisions referred to in point (a) do not apply to Danish social pension entitlement for the members of the family of persons who are or have been gainfully employed in Denmark, or for students or the members of their families. 3. The temporary benefit for unemployed persons who have been admitted to the ledighedsydelse (flexible job' scheme) (Law No 455 of 10 June 1997) is covered by Chapter 6 of Title III of this Protocol. 4. Where the beneficiary of a Danish social pension is also entitled to a survivor's pension from another State, those pensions for the implementation of Danish legislation shall be regarded as benefits of the same kind within the meaning of Article SSC.48(1), subject to the condition, however, that the person whose periods of insurance or of residence serve as the basis for the calculation of the survivor's pension had also acquired a right to a Danish social pension. ESTONIA For the purpose of calculating parental benefits, periods of employment in States other than Estonia shall be considered to be based on the same average amount of Social Tax as paid during the periods of employment in Estonia with which they are aggregated. If during the reference year the person has been employed only in other States, the calculation of the benefit shall be considered to be based on the average Social Tax paid in Estonia between the reference year and the maternity leave. FINLAND 1. For the purposes of determining entitlement and of calculating the amount of the Finnish national pension under Articles SSC.47, SSC.48 and SSC.49 of this Protocol, pensions acquired under the legislation of another State are treated in the same way as pensions acquired under Finnish legislation. 2. When applying point (b)(i) of Article SSC.47(1) of this Protocol for the purpose of calculating earnings for the credited period under Finnish legislation on earnings-related pensions, where an individual has pension insurance periods based on activity as an employed or self-employed person in another State for part of the reference period under Finnish legislation, the earnings for the credited period shall be equivalent to the sum of earnings obtained during the part of the reference period in Finland, divided by the number of months for which there were insurance periods in Finland during the reference period. FRANCE 1. For persons receiving benefits in kind in France pursuant to Article SSC.15 or SSC.24 of this Protocol who are resident in the French departments of Haut-Rhin, Bas-Rhin or Moselle, benefits in kind provided on behalf of the institution of another State which is responsible for bearing their cost include benefits provided by both the general sickness insurance scheme and the obligatory supplementary local sickness insurance scheme of Alsace-Moselle. 2. French legislation applicable to a person engaged, or formerly engaged, in an activity as an employed or self-employed person for the application of Chapter 5 of Title III of this Protocol includes both the basic old-age insurance scheme(s) and the supplementary retirement scheme(s) to which the person concerned was subject. GERMANY 1. Notwithstanding point (a) of Article SSC.6 of this Protocol and point 1 of Article 5(4) of the Sozialgesetzbuch VI (Volume VI of the Social Code), a person who receives a full old-age pension under the legislation of another State may request to be compulsorily insured under the German pension insurance scheme. 2. Notwithstanding point (a) of Article SSC.6 of this Protocol and Article 7 of the Sozialgesetzbuch VI (Volume VI of the Social Code), a person who is compulsorily insured in another State, or receives an old-age pension under the legislation of another State may join the voluntary insurance scheme in Germany. 3. For the purpose of granting cash benefits under \u00a747(1) of SGB V, \u00a747(1) of SGB VII and \u00a7200(2) of the Reichsversicherungsordnung to insured persons who live in another State, German insurance schemes calculate net pay, which is used to assess benefits, as if the insured person lived in Germany, unless the insured person requests an assessment on the basis of the net pay which he actually receives. 4. Nationals of other States whose place of residence or usual abode is outside Germany and who fulfil the general conditions of the German pension insurance scheme may pay voluntary contributions only if they had been voluntarily or compulsorily insured in the German pension insurance scheme at some time previously; this also applies to stateless persons and refugees whose place of residence or usual abode is in another State. 5. The pauschale Anrechnungszeit (fixed credit period) pursuant to Article 253 of the Sozialgesetzbuch VI (Volume VI of the Social Code) shall be determined exclusively with reference to German periods. 6. In cases where the German pension legislation, in force on 31 December 1991, is applicable for the recalculation of a pension, only the German legislation applies for the purposes of crediting German Ersatzzeiten (substitute periods). 7. The German legislation on accidents at work and occupational diseases to be compensated for under the law governing foreign pensions and on benefits for insurance periods which can be credited under the law governing foreign pensions in the territories named in paragraph 1(2)(3) of the Act on affairs of displaced persons and refugees (Bundesvertriebenengesetz) continues to apply within the scope of application of this Protocol, notwithstanding the provisions of paragraph 2 of the Act on foreign pensions (Fremdrentengesetz). 8. For the calculation of the theoretical amount referred to in point (b)(i) of Article SSC.47(1) of this Protocol, in pension schemes for liberal professions, the competent institution shall take as a basis, in respect of each of the years of insurance completed under the legislation of any other State, the average annual pension entitlement acquired during the period of membership of the competent institution through the payment of contributions. GREECE 1. Law No 1469/84 concerning voluntary affiliation to the pension insurance scheme for Greek nationals and foreign nationals of Greek origin is applicable to nationals of other States, stateless persons and refugees, where the persons concerned, regardless of their place of residence or stay, have at some time in the past been compulsorily or voluntarily affiliated to the Greek pension insurance scheme. 2 Notwithstanding point (a) of Article SSC.6 of this Protocol and Article 34 of Law 1140/1981, a person who receives a pension in respect of accidents at work or occupational diseases under the legislation of another State may request to be compulsorily insured under the legislation applied by OGA, to the extent that they pursue an activity falling within the scope of that legislation. IRELAND 1. Notwithstanding Article SSC.19(2) and Article SSC.57 of this Protocol, for the purposes of calculating the prescribed reckonable weekly earnings of an insured person for the grant of sickness or unemployment benefit under Irish legislation, an amount equal to the average weekly wage of employed persons in the relevant prescribed year shall be credited to that insured person in respect of each week of activity as an employed person under the legislation of another State during that prescribed year. MALTA Special provisions for civil servants (a) Solely for the purposes of the application of Articles SSC.43 and SSC.55 of this Protocol, persons employed under the Malta Armed Forces Act (Chapter 220 of the Laws of Malta), the Police Act (Chapter 164 of the Laws of Malta) and the Prisons Act (Chapter 260 of the Laws of Malta) shall be treated as civil servants. (b) Pensions payable under the above Acts and under the Pensions Ordinance (Chapter 93 of the Laws of Malta) shall, solely for the purposes of point (cc) of Article SSC.1 of this Protocol, be considered as \"special schemes for civil servants\". NETHERLANDS 1. Health care insurance (a) As regards entitlement to benefits in kind under Dutch legislation, persons entitled to benefits in kind for the purpose of the implementation of Chapters 1 and 2 of Title III of this Protocol shall mean: (i) persons who, under Article 2 of the Zorgverzekeringswet (Health Care Insurance Act), are obliged to take out insurance under a health care insurer; and (ii) in so far as they are not already included under point (i), members of the family of active military personnel who are living in another State and persons who are resident in another State and who, under this Protocol, are entitled to health care in their state of residence, the costs being borne by the Netherlands. (b) The persons referred to in point 1(a)(i) must, in accordance with the provisions of the Zorgverzekeringswet (Health Care Insurance Act), take out insurance with a health care insurer, and the persons referred to in point 1(a)(ii) must register with the College voor zorgverzekeringen (Health Care Insurance Board). (c) The provisions of the Zorgverzekeringswet (Health Care Insurance Act) and the Algemene Wet Bijzondere Ziektekosten (General Act on Exceptional Medical Expenses) concerning liability for the payment of contributions shall apply to the persons referred to in point (a) and the members of their families. In respect of members of the family, the contributions shall be levied on the person from whom the right to health care is derived with the exception of the members of the family of military personnel living in another State, who shall be levied directly. (d) The provisions of the Zorgverzekeringswet (Health Care Insurance Act) concerning late insurance shall apply mutatis mutandis in the event of late registration with the College voor zorgverzekeringen (Health Care Insurance Board) in respect of the persons referred to in point (a)(ii). (e) Persons entitled to benefits in kind by virtue of the legislation of a State other than the Netherlands who reside in the Netherlands or stay temporarily in the Netherlands shall be entitled to benefits in kind in accordance with the policy offered to insured persons in the Netherlands by the institution of the place of residence or the place of stay, taking into account Article 11(1), (2) and (3) and Article 19(1) of the Zorgverzekeringswet (Health Care Insurance Act), as well as to benefits in kind provided for by the Algemene Wet Bijzondere Ziektekosten (General Act on Exceptional Medical Expenses). (f) For the purposes of Articles SSC.21 to SSC.27 of this Protocol, the following benefits, in addition to pensions covered by Chapters 4 and 5 of Title III of this Protocol, shall be treated as pensions due under Dutch legislation: \u2014 pensions awarded under the Law of 6 January 1966 on pensions for civil servants and their survivors (Algemene burgerlijke pensioenwet) (Netherlands Civil Service Pensions Act), \u2014 pensions awarded under the Law of 6 October 1966 on pensions for military personnel and their survivors (Algemene militaire pensioenwet) (Military Pensions Act), \u2014 benefits for incapacity for work awarded under the Law of 7 June 1972 on benefits for incapacity for work for military personnel (Wetarbeidsongeschiktheidsvoorziening militairen) (Military Personnel Incapacity for Work Act), \u2014 pensions awarded under the Law of 15 February 1967 on pensions for employees of the NV Nederlandse Spoorwegen (Dutch Railway Company) and their survivors (Spoorwegpensioenwet) (Railway Pensions Act), \u2014 pensions awarded under the Reglement Dienstvoorwaarden Nederlandse Spoorwegen (governing conditions of employment of the Netherlands Railway Company), \u2014 benefits awarded to retired persons before reaching the pensionable age of 65 years under a pension designed to provide income for former employed persons in their old age, or benefits provided in the event of premature exit from the labour market under a scheme set up by the state or by an industrial agreement for persons aged 55 or over, \u2014 benefits awarded to military personnel and civil servants under a scheme applicable in the event of redundancy, superannuation and early retirement. (g) For the purposes of Article SSC.16(1) of this Protocol, the persons referred to in point (a)(ii) of this paragraph who stay temporarily in the Netherlands shall be entitled to benefits in kind in accordance with the policy offered to insured persons in the Netherlands by the institution of the place of stay, taking into account Article 11(1), (2) and (3) and Article 19(1) of the Zorgverzekeringswet (Health Care Insurance Act), as well as to benefits in kind provided for by the Algemene Wet Bijzondere Ziektekosten (General Act on Exceptional Medical Expenses). 2. Application of the Algemene Ouderdomswet (AOW) (General Old Age Pensions Act) (a) The reduction referred to in Article 13(1) of the AOW (General Old Age Pensions Act) shall not be applied for calendar years before 1 January 1957 during which a recipient not satisfying the conditions for having such years treated as periods of insurance: \u2014 resided in the Netherlands between the ages of 15 and 65, \u2014 while residing in another State, worked in the Netherlands for an employer established in the Netherlands, or \u2014 worked in another State during periods regarded as periods of insurance under the Dutch social security system. By way of derogation from Article 7 of the AOW, anyone who resided or worked in the Netherlands in accordance with the above conditions only prior to 1 January 1957 shall also be regarded as being entitled to a pension. (b) The reduction referred to in Article 13(1) of the AOW shall not apply to calendar years prior to 2 August 1989 during which a person, between the ages of 15 and 65, who is or was married was not insured under the above legislation, while being resident in the territory of a State other than the Netherlands, if these calendar years coincide with periods of insurance completed by the person's spouse under the above legislation or with calendar years to be taken into account under point 2(a), provided that the couple's marriage subsisted during that time. By way of derogation from Article 7 of the AOW, such a person shall be regarded as being entitled to a pension. (c) The reduction referred to in Article 13(2) of the AOW shall not apply to calendar years before 1 January 1957 during which a pensioner's spouse who fails to satisfy the conditions for having such years treated as periods of insurance: \u2014 resided in the Netherlands between the ages of 15 and 65, or \u2014 while residing in another State, worked in the Netherlands for an employer established in the Netherlands, or \u2014 worked in another State during periods regarded as periods of insurance under the Netherlands social security system. (d) The reduction referred to in Article 13(2) of the AOW shall not apply to calendar years prior to 2 August 1989 during which a pensioner's spouse resident in a State other than the Netherlands, between the ages of 15 and 65, was not insured under the AOW, if those calendar years coincide with periods of insurance completed by the pensioner under that legislation or with calendar years to be taken into account under point 2(a), provided that the couple's marriage subsisted during that time. (e) Points 2(a), 2(b), 2(c) and 2(d) shall not apply to periods which coincide with: \u2014 periods which may be taken into account for calculating pension rights under the old-age insurance legislation of a State other than the Netherlands, or \u2014 periods for which the person concerned has drawn an old-age pension under such legislation. Periods of voluntary insurance under the system of another State shall not be taken into account for the purposes of this point. (f) Points 2(a), 2(b), 2(c) and 2(d) shall apply only if the person concerned has resided in one or more States for 6 years after the age of 59 and only for such time as that person is resident in one of those States. (g) By way of derogation from Chapter IV of the AOW, anyone resident in a State other than the Netherlands whose spouse is covered by compulsory insurance under that legislation shall be authorised to take out voluntary insurance under that legislation for periods during which the spouse is compulsorily insured. This authorisation shall not cease where the spouse's compulsory insurance is terminated as a result of their death and where the survivor receives only a pension under the Algemene nabestaandenwet (General Surviving Relatives Act). In any event, the authorisation in respect of voluntary insurance ceases on the date on which the person reaches the age of 65. The contribution to be paid for voluntary insurance shall be set in accordance with the provisions relating to the determination of the contribution for voluntary insurance under the AOW. However, if the voluntary insurance follows on from a period of insurance as referred to in point 2(b), the contribution shall be set in accordance with the provisions relating to the determination of the contribution for compulsory insurance under the AOW, with the income to be taken into account being deemed to have been received in the Netherlands. (h) The authorisation referred to in point 2(g) shall not be granted to anyone insured under another State's legislation on pensions or survivors' benefits. (i) Anyone wishing to take out voluntary insurance under point 2(g) shall be required to apply for it to the Social Insurance Bank (Sociale Verzekeringsbank) not later than 1 year after the date on which the conditions for participation are fulfilled. 3. Application of the Algemene nabestaandenwet (ANW) (General Surviving Relatives Act) (a) Where the surviving spouse is entitled to a survivor's pension under the ANW (General Surviving Relatives Act) pursuant to Article SSC.46(3) of this Protocol, that pension shall be calculated in accordance with point (b) of Article SSC.47(1) of this Protocol. For the application of these provisions, periods of insurance prior to 1 October 1959 shall also be regarded as periods of insurance completed under Dutch legislation if during those periods the insured person, after the age of 15: \u2014 resided in the Netherlands; or \u2014 while resident in another State, worked in the Netherlands for an employer established in the Netherlands; or \u2014 worked in another State during periods regarded as periods of insurance under the Dutch social security system. (b) Account shall not be taken of the periods to be taken into consideration under point 3(a) which coincide with periods of compulsory insurance completed under the legislation of another State in respect of survivor's pensions. (c) For the purposes of point (b) of Article SSC.47(1) of this Protocol, only periods of insurance completed under Dutch legislation after the age of 15 shall be taken into account as periods of insurance. (d) By way of derogation from Article 63a(1) of the ANW, a person resident in a State other than the Netherlands whose spouse is compulsorily insured under the ANW shall be authorised to take out voluntary insurance under the ANW provided that such insurance has already begun by the date of application of this Protocol, but only for periods during which the spouse is compulsorily insured. That authorisation shall cease as from the date of termination of the spouse's compulsory insurance under the ANW, unless the spouse's compulsory insurance is terminated as a result of their death and where the survivor only receives a pension under the ANW. In any event, the authorisation in respect of voluntary insurance ceases on the date on which the person reaches the age of 65. The contribution to be paid for voluntary insurance shall be set in accordance with the provisions relating to the determination of contributions for voluntary insurance under the ANW. However, if the voluntary insurance follows on from a period of insurance as referred to in point 2(b), the contribution shall be set in accordance with the provisions relating to the determination of contributions for compulsory insurance under the ANW, with the income to be taken into account being deemed to have been received in the Netherlands. 4. Application of Dutch legislation relating to incapacity for work In calculating benefits under either the WAO, WIA or the WAZ, the Netherlands institutions shall take account of: \u2014 periods of paid employment, and periods treated as such, completed in the Netherlands before 1 July 1967, \u2014 periods of insurance completed under the WAO, \u2014 periods of insurance completed by the person concerned, after the age of 15, under the Algemene Arbeidsongeschiktheidswet (General Act on Incapacity for Work), in so far as they do not coincide with the periods of insurance completed under the WAO, \u2014 periods of insurance completed under the WAZ, \u2014 periods of insurance completed under the WIA. SPAIN 1. For the purpose of implementing point (1)(b) of Article SSC.47(1) of this Protocol, the years which the worker lacks to reach the pensionable or compulsory retirement age as stipulated under Article 31(4) of the consolidated version of the Ley de Clases Pasivas del Estado (Law on State Pensioners) shall be taken into account as actual years of service to the State only if at the time of the event in respect of which death pensions are due, the beneficiary was covered by Spain's special scheme for civil servants or was performing an activity assimilated under the scheme, or if, at the time of the event in respect of which the pensions are due, the beneficiary was performing an activity that would have required the person concerned to be included under the State's special scheme for civil servants, the armed forces or the judiciary, had the activity been performed in Spain. 2. (a) Under point (c) of Article SSC.51(1), the calculation of the theoretical Spanish benefit shall be carried out on the basis of the actual contributions of the person during the years immediately preceding payment of the last contribution to Spanish social security. Where, in the calculation of the basic amount for the pension, periods of insurance and/or residence under the legislation of other States have to be taken into account, the contribution basis in Spain which is closest in time to the reference periods shall be used for those periods, taking into account the development of the retail price index. (b) The amount of the pension obtained shall be increased by the amount of the increases and revaluations calculated for each subsequent year for pensions of the same nature. 3. Periods completed in other States which must be calculated in the special scheme for civil servants, the armed forces and the judicial administration, will be treated in the same way, for the purposes of Article SSC.51 of this Protocol, as the periods closest in time covered as a civil servant in Spain. 4. The additional amounts based on age referred to in the Second Transitional Provision of the General Law on Social Security shall be applicable to all beneficiaries under this Protocol who have contributions to their name under the Spanish legislation prior to 1 January 1967; it shall not be possible, by application of Article SSC.6 of this Protocol, to treat periods of insurance credited in another State prior to 1 January 1967 as being the same as contributions paid in Spain, solely for the purposes of this Protocol. The date corresponding to 1 January 1967 shall be 1 August 1970 for the Special Scheme for Seafarers and 1 April 1969 for the Special Social Security Scheme for Coal Mining. SWEDEN 1. The provisions of this Protocol on the aggregation of insurance periods and periods of residence shall not apply to the transitional provisions in the Swedish legislation on entitlement to guarantee pension for persons born in or before 1937 who have been resident in Sweden for a specified period before applying for a pension (Act 2000:798). 2. For the purpose of calculating income for notional income-related sickness compensation and income-related activity compensation in accordance with Chapter 8 of the Lag (1962:381) om allm\u00e4n f\u00f6rs\u00e4kring (the National Insurance Act), the following shall apply: (a) where the insured person, during the reference period, has also been subject to the legislation of one or more other States on account of activity as an employed or self-employed person, income in the State(s) concerned shall be deemed to be equivalent to the insured person's average gross income in Sweden during the part of the reference period in Sweden, calculated by dividing the earnings in Sweden by the number of years over which those earnings accrued; 3. (a) For the purpose of calculating notional pension assets for income-based survivor's pension (Act 2000:461), if the requirement in Swedish legislation for pension entitlement in respect of at least three out of the 5 calendar years immediately preceding the insured person's death (reference period) is not met, account shall also be taken of insurance periods completed in other States as if they had been completed in Sweden. Insurance periods in other States shall be regarded as based on the average Swedish pension base. If the person concerned has only 1 year in Sweden with a pension base, each insurance period in another State shall be regarded as constituting the same amount. (b) For the purpose of calculating notional pension credits for widows' pensions relating to deaths on or after 1 January 2003, if the requirement in Swedish legislation for pension credits in respect of at least two out of the 4 years immediately preceding the insured person's death (reference period) is not met and insurance periods were completed in another State during the reference period, those years shall be regarded as being based on the same pension credits as the Swedish year. UNITED KINGDOM 1. Where, in accordance with United Kingdom legislation, a person may be entitled to a retirement pension if: (a) the contributions of a former spouse are taken into account as if they were that person's own contributions; or (b) the relevant contribution conditions are satisfied by that person's spouse or former spouse, then provided, in each case, that the spouse or former spouse is or had been exercising an activity as an employed or self-employed person, and had been subject to the legislation of two or more States, the provisions of Chapter 5 of Title III of this Protocol shall apply in order to determine entitlement under United Kingdom legislation. In that case, references in Articles SSC.44 to SSC.55 of this Protocol to \"periods of insurance\" shall be construed as references to periods of insurance completed by: (i) a spouse or former spouse where a claim is made by: \u2014 a married woman, or \u2014 a person whose marriage has terminated otherwise than by the death of the spouse; or (ii) a former spouse, where a claim is made by: \u2014 a widower who immediately before pensionable age is not entitled to a widowed parent's allowance, or \u2014 a widow who immediately before pensionable age is not entitled to a widowed mother's allowance, widowed parent's allowance or widow's pension, or who is only entitled to an age-related widow's pension calculated pursuant to point (b) of Article SSC.47(1) of this Protocol, and for this purpose \u2018age related widow's pension\u2019 means a widow's pension payable at a reduced rate in accordance with section 39(4) of the Social Security Contributions and Benefits Act 1992. 2. For the purposes of Article SSC.8 of this Protocol in the case of old-age or survivors' cash benefits, pensions for accidents at work or occupational diseases and death grants, any beneficiary under United Kingdom legislation who is staying in the territory of another State shall, during that stay, be considered as if they resided in the territory of that other State. 3. (1) For the purpose of calculating an earnings factor in order to determine entitlement to benefits under United Kingdom legislation, for each week of activity as an employed person under the legislation of a Member State, and which commenced during the relevant income tax year within the meaning of United Kingdom legislation, the person concerned shall be deemed to have paid contributions as an employed earner, or have earnings on which contributions have been paid, on the basis of earnings equivalent to two-thirds of that year's upper earnings limit. (2) For the purposes of point (b) of Article SSC.47(1) of this Protocol, where: (a) in any income tax year starting on or after 6 April 1975, a person carrying out activity as an employed person has completed periods of insurance, employment or residence exclusively in a Member State, and the application of point (1) of this paragraph results in that year being counted as a qualifying year within the meaning of United Kingdom legislation for the purposes of point (b)(i) of Article SSC.47(1) of this Protocol, they shall be deemed to have been insured for 52 weeks in that year in that Member State; (b) any income tax year starting on or after 6 April 1975 does not count as a qualifying year within the meaning of United Kingdom legislation for the purposes of point (b)(i) of Article SSC.47(1) of this Protocol, any periods of insurance, employment or residence completed in that year shall be disregarded. (3) For the purpose of converting an earnings factor into periods of insurance, the earnings factor achieved in the relevant income tax year within the meaning of United Kingdom legislation shall be divided by that year's lower earnings limit. The result shall be expressed as a whole number, any remaining fraction being ignored. The figure so calculated shall be treated as representing the number of weeks of insurance completed under United Kingdom legislation during that year, provided that such figure shall not exceed the number of weeks during which in that year the person was subject to that legislation. ANNEX SSC-7 IMPLEMENTING PART TITLE I GENERAL PROVISIONS CHAPTER 1 Article SSCI.1 Definitions 1. For the purposes of this Annex, the definitions set out in Article SSC.1 of this Protocol apply. 2. In addition to the definitions referred to in paragraph 1: (a) \"access point\" means an entity providing: (i) an electronic contact point; (ii) automatic routing based on the address; and (iii) intelligent routing based on software that enables automatic checking and routing (for example, an artificial intelligence application) or human intervention; (b) \"liaison body\" means any body designated by the competent authority of a State for one or more of the branches of social security referred to in Article SSC.3 of this Protocol to respond to requests for information and assistance for the purposes of the application of this Protocol and of this Annex and which has to fulfil the tasks assigned to it under Title IV of this Annex; (c) \"document\" means a set of data, irrespective of the medium used, structured in such a way that it can be exchanged electronically and which must be communicated in order to enable the operation of this Protocol and this Annex; (d) \"Structured Electronic Document\" means any structured document in a format designed for the electronic exchange of information between States; (e) \"transmission by electronic means\" means the transmission of data using electronic equipment for the processing (including digital compression) of data and employing wires, radio transmission, optical technologies or any other electromagnetic means; (f) \"fraud\" means any deliberate act or deliberate omission to act, carried out with the intention to either: (i) receive social security benefits, or enable another person to receive social security benefits, when the conditions of entitlement to such benefits under the law of the State(s) concerned or this Protocol are not met; or (ii) avoid paying social security contributions, or enable another person to avoid paying social security contributions, when such contributions are required under the law of the State(s) concerned or this Protocol. CHAPTER 2 PROVISIONS CONCERNING COOPERATION AND EXCHANGES OF DATA Article SSCI.2 Scope and rules for exchanges between institutions 1. For the purposes of this Annex, exchanges between authorities of the States and institutions and persons covered by this Protocol shall be based on the principles of public service, efficiency, active assistance, rapid delivery and accessibility, including e-accessibility, in particular for the disabled and the elderly. 2. The institutions shall without delay provide or exchange all data necessary for establishing and determining the rights and obligations of persons to whom this Protocol applies. Such data shall be transferred between the States directly by the institutions themselves or indirectly via the liaison bodies. 3. Where a person has mistakenly submitted information, documents or claims to an institution in the territory of a State other than that in which the institution designated, in accordance with this Annex, is situated, the information, documents or claims shall be resubmitted without delay by the former institution to the institution designated in accordance with this Annex, indicating the date on which they were initially submitted. That date shall be binding on the latter institution. The institutions of the States shall not, however, be held liable, or be deemed to have taken a decision by virtue of their failure to act as a result of the late transmission of information, documents or claims by States' institutions. 4. Where data are transferred indirectly via the liaison body of the State of destination, time limits for responding to claims shall start from the date when that liaison body received the claim, as if it had been received by the institution in that State. Article SSCI.3 Scope and rules for exchanges between the persons concerned and institutions 1. The States shall ensure that the necessary information is made available to the persons concerned in order to inform them of the provisions introduced by this Protocol and this Annex to enable them to assert their rights. They shall also provide for user-friendly services. 2. Persons to whom this Protocol applies shall be required to forward to the relevant institution the information, documents or supporting evidence necessary to establish their situation or that of their families, to establish or maintain their rights and obligations and to determine the applicable legislation and their obligations under it. 3. To the extent necessary for the application of this Protocol and this Annex, the relevant institutions shall forward the information and issue the documents to the persons concerned without delay and in all cases within any time limits specified under the legislation of the State in question. The relevant institution shall notify the claimant residing or staying in another State of its decision directly or through the liaison body of the State of residence or stay. When refusing the benefits, it shall also indicate the reasons for refusal, the remedies and periods allowed for appeals. A copy of this decision shall be sent to other involved institutions. Article SSCI.4 Forms, documents and methods of exchanging data 1. Subject to Article SSCI.75 and Appendix SSCI-2, the structure, content and format of forms and documents issued on behalf of the States for the purposes of implementing this Protocol shall be agreed by the Specialised Committee on Social Security Coordination. 2. The transmission of data between the institutions or the liaison bodies may, subject to the approval of the Specialised Committee on Social Security Coordination, be carried out via the Electronic Exchange of Social Security Information. To the extent the forms and documents referred to in paragraph 1 are exchanged via the Electronic Exchange of Social Security Information, they shall respect the rules applicable to that system. Where the transmission of data between institutions or the liaison bodies is not carried out via the Electronic Exchange of Social Security Information, the relevant institutions and liaison bodies shall use the arrangements appropriate to each case, and favour the use of electronic means as far as possible. 3. In their communications with the persons concerned, the relevant institutions shall use the arrangements appropriate to each case, and favour the use of electronic means as far as possible. Article SSCI.5 Legal value of documents and supporting evidence issued in another State 1. Documents issued by the institution of a State and showing the position of a person for the purposes of the application of this Protocol and this Annex, and supporting evidence on the basis of which the documents have been issued, shall be accepted by the institutions of the other States for as long as they have not been withdrawn or declared to be invalid by the State in which they were issued. 2. Where there is doubt about the validity of a document or the accuracy of the facts on which the particulars contained therein are based, the institution of the State that receives the document shall ask the issuing institution for the necessary clarification and, where appropriate, the withdrawal of that document. The issuing institution shall reconsider the grounds for issuing the document and, if necessary, withdraw it. 3. Pursuant to paragraph 2, where there is doubt about the information provided by the persons concerned, the validity of a document or supporting evidence or the accuracy of the facts on which the particulars contained therein are based, the institution of the place of stay or residence shall, insofar as this is possible, at the request of the competent institution, proceed to the necessary verification of this information or document. 4. Where no agreement is reached between the institutions concerned, the matter may be brought before the Specialised Committee on Social Security Coordination by the competent authorities no earlier than one month following the date on which the institution that received the document submitted its request. The Specialised Committee on Social Security Coordination shall endeavour to reconcile the points of view within six months of the date on which the matter was brought before it. Article SSCI.6 Provisional application of legislation and provisional granting of benefits 1. Unless otherwise provided for in this Annex, where there is a difference of views between the institutions or authorities of two or more States concerning the determination of the applicable legislation, the person concerned shall be made provisionally subject to the legislation of one of those States, the order of priority being determined as follows: (a) the legislation of the State where the person actually pursues their employment or self-employment, if the employment or self-employment is pursued in only one State; (b) the legislation of the State of residence if the person concerned pursues employment or self-employment in two or more States and performs part of their activity or activities in the State of residence, or if the person concerned is neither employed nor self-employed; (c) in all other cases, the legislation of the State the application of which was first requested if the person pursues an activity, or activities, in two or more States. 2. Where there is a difference of views between the institutions or authorities of two or more States about which institution should provide the benefits in cash or in kind, the person concerned who could claim benefits if there was no dispute shall be entitled, on a provisional basis, to the benefits provided for by the legislation applied by the institution of that person's place of residence or, if that person does not reside on the territory of one of the States concerned, to the benefits provided for by the legislation applied by the institution to which the request was first submitted. 3. Where no agreement is reached between the institutions or authorities concerned, the matter may be brought before the Specialised Committee on Social Security Coordination by a Party no earlier than one month after the date on which the difference of views, as referred to in paragraph 1 or 2, arose. The Specialised Committee on Social Security Coordination shall seek to reconcile the points of view within six months of the date on which the matter was brought before it. 4. Where it is established either that the applicable legislation is not that of the State of provisional membership, or the institution which granted the benefits on a provisional basis was not the competent institution, the institution identified as being competent shall be deemed retroactively to have been so, as if that difference of views had not existed, at the latest from either the date of provisional membership or of the first provisional granting of the benefits concerned. 5. If necessary, the institution identified as being competent and the institution which provisionally paid the cash benefits or provisionally received contributions shall settle the financial situation of the person concerned as regards contributions and cash benefits paid provisionally, where appropriate, in accordance with Chapter 2 of Title IV of this Annex. Benefits in kind granted provisionally by an institution in accordance with paragraph 2 shall be reimbursed by the competent institution in accordance with Title IV of this Annex. Article SSCI.7 Provisional calculation of benefits and contributions 1. Unless otherwise provided for in this Annex, where a person is eligible for a benefit, or is liable to pay a contribution in accordance with this Protocol, and the competent institution does not have all the information concerning the situation in another State which is necessary to calculate definitively the amount of that benefit or contribution, that institution shall, on request of the person concerned, award this benefit or calculate this contribution on a provisional basis, if such a calculation is possible on the basis of the information at the disposal of that institution. 2. The benefit or the contribution concerned shall be recalculated once all the necessary supporting evidence or documents are provided to the institution concerned. CHAPTER 3 OTHER GENERAL PROVISIONS FOR THE APPLICATION OF THIS PROTOCOL Article SSCI.8 Other procedures between authorities and institutions 1. Two or more States, or their competent authorities, may agree procedures other than those provided for by this Annex, provided that such procedures do not adversely affect the rights or obligations of the persons concerned. 2. Any agreements concluded to this end shall be notified to the Specialised Committee on Social Security Coordination and listed in Appendix SSCI-1. 3. Provisions contained in implementing agreements concluded between two or more States with the same purpose as, or which are similar to, those referred to in paragraph 2, which are in force on the day preceding the entry into force of this Agreement, shall continue to apply, for the purposes of relations between those States, provided they are also included in Appendix SSCI-1 to this Protocol. Article SSCI.9 Prevention of overlapping of benefits Notwithstanding other provisions in this Protocol, when benefits due under the legislation of two or more States are mutually reduced, suspended or withdrawn, any amounts that would not be paid in the event of strict application of the rules concerning reduction, suspension or withdrawal laid down by the legislation of the State concerned shall be divided by the number of benefits subjected to reduction, suspension or withdrawal. Article SSCI.10 Elements for determining residence 1. Where there is a difference of views between the institutions of two or more States about the determination of the residence of a person to whom this Protocol applies, these institutions shall establish by common agreement the centre of interests of the person concerned, based on an overall assessment of all available information relating to relevant facts, which may include, as appropriate: (a) the duration and continuity of presence on the territory of the States concerned; (b) that person's situation, including: (i) the nature and the specific characteristics of any activity pursued, in particular the place where such activity is habitually pursued, the stability of the activity, and the duration of any work contract; (ii) that person's family status and family ties; (iii) the exercise of any non-remunerated activity; (iv) in the case of students, the source of that student's income; (v) that person's housing situation, in particular how permanent it is; (vi) the State in which that person is deemed to reside for taxation purposes. 2. Where the consideration of the various criteria based on relevant facts as set out in paragraph 1 does not lead to agreement between the institutions concerned, the person's intention, as it appears from such facts and circumstances, especially the reasons that led the person to move, shall be considered to be decisive for establishing that person's actual place of residence. 3. The centre of interests of a student who goes to another State to pursue a full-time course of study shall not be considered as being in the State of study for the entire duration of the course of study in that State, without prejudice to the possibility of rebutting this presumption. 4. Paragraph 3 applies mutatis mutandis to the family members of the student. Article SSCI.11 Aggregation of periods 1. For the purposes of applying Article SSC.7, the competent institution shall contact the institutions of the States to whose legislation the person concerned has also been subject in order to determine all the periods completed under their legislation. 2. The respective periods of insurance, employment, self-employment or residence completed under the legislation of a State shall be added to those completed under the legislation of any other State, insofar as necessary for the purposes of applying Article SSC.7, provided that these periods do not overlap. 3. Where a period of insurance or residence which is completed in accordance with compulsory insurance under the legislation of a State coincides with a period of insurance completed on the basis of voluntary insurance or continued optional insurance under the legislation of another State, only the period completed on the basis of compulsory insurance shall be taken into account. 4. Where a period of insurance or residence other than an equivalent period completed under the legislation of a State coincides with an equivalent period on the basis of the legislation of another State, only the period other than an equivalent period shall be taken into account. 5. Any period regarded as equivalent under the legislation of two or more States shall be taken into account only by the institution of the State to whose legislation the person concerned was last compulsorily subject before that period. In the event that the person concerned was not compulsorily subject to the legislation of a State before that period, the latter shall be taken into account by the institution of the State to whose legislation the person concerned was compulsorily subject for the first time after that period. 6. In the event that the time in which certain periods of insurance or residence were completed under the legislation of a State cannot be determined precisely, it shall be presumed that these periods do not overlap with periods of insurance or residence completed under the legislation of another State, and account shall be taken thereof, where advantageous to the person concerned, insofar as they can reasonably be taken into consideration. Article SSCI.12 Rules for conversion of periods 1. Where periods completed under the legislation of a State are expressed in units different from those provided for by the legislation of another State, the conversion needed for the purpose of aggregation under Article SSC.7 shall be carried out under the following rules: (a) the period to be used as the basis for the conversion shall be that communicated by the institution of the State under whose legislation the period was completed; (b) in the case of schemes where the periods are expressed in days the conversion from days to other units, and vice versa, as well as between different schemes based on days shall be calculated according to the following table: Scheme based on 1 day corresponds to 1 week corresponds to 1 month corresponds to 1 quarter corresponds to Maximum of days in one calendar year 5 days 9 hours 5 days 22 days 66 days 264 days 6 days 8 hours 6 days 26 days 78 days 312 days 7 days 6 hours 7 days 30 days 90 days 360 days (c) in the case of schemes where the periods are expressed in units other than days, (i) three months or 13 weeks shall be equivalent to one quarter, and vice versa; (ii) one year shall be equivalent to four quarters, 12 months or 52 weeks, and vice versa; (iii) for the conversion of weeks into months, and vice versa, weeks and months shall be converted into days in accordance with the conversion rules for the schemes based on six days in the table in point (b); (d) in the case of periods expressed in fractions, those figures shall be converted into the next smaller integer unit applying the rules laid down in points (b) and (c). Fractions of years shall be converted into months unless the scheme involved is based on quarters; (e) if the conversion under this paragraph results in a fraction of a unit, the next higher integer unit shall be taken as the result of the conversion under this paragraph. 2. The application of paragraph 1 shall not have the effect of producing, for the total sum of the periods completed during one calendar year, a total exceeding the number of days indicated in the last column in the table in point (b) of paragraph 1, 52 weeks, 12 months or four quarters. If the periods to be converted correspond to the maximum annual amount of periods under the legislation of the State in which they have been completed, the application of paragraph 1 shall not result within one calendar year in periods that are shorter than the possible maximum annual amount of periods provided under the legislation concerned. 3. The conversion shall be carried out either in one single operation covering all those periods which were communicated as an aggregate, or for each year, if the periods were communicated on a year-by-year basis. 4. Where an institution communicates periods expressed in days, it shall at the same time indicate whether the scheme it administers is based on five days, six days or seven days. TITLE II DETERMINATION OF THE LEGISLATION APPLICABLE Article SSCI.13 Details relating to Articles SSC.11 and SSC.12 of this Protocol 1. For the purposes of the application of point (a) of Article SSC.11(1), a \"person who pursues an activity as an employed person in a State for an employer which normally carries out its activities there and who is sent by that employer to another State\" shall include a person who is recruited with a view to being sent to another State, provided that, immediately before the start of that person's employment, the person concerned is already subject to the legislation of the State in which their employer is established. 2. For the purposes of the application of point (a) of Article SSC.11(1) of this Protocol, the words \"which normally carries out its activities there\" shall refer to an employer that ordinarily performs substantial activities, other than purely internal management activities, in the territory of the State in which it is established, taking account of all criteria characterising the activities carried out by the undertaking in question. The relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out. 3. For the purposes of the application of point (b) of Article SSC.11(1) of this Protocol, the words \"who normally pursues an activity as a self-employed person\" shall refer to a person who habitually carries out substantial activities in the territory of the State in which that person is established. In particular, that person must have already pursued their activity for some time before the date when they wish to take advantage of the provisions of that Article and, during any period of temporary activity in another State, must continue to fulfil, in the State where they are established, the requirements for the pursuit of their activity in order to be able to pursue it on their return. 4. For the purposes of the application of point (b) of Article SSC.11(1) of this Protocol, the criterion for determining whether the activity that a self-employed person goes to pursue in another State is \"similar\" to the self-employed activity normally pursued shall be that of the actual nature of the activity, rather than of the designation of employed or self-employed activity that may be given to this activity by the other State. 5. For the purposes of the application of Article SSC.12(1) and (5) of this Protocol, a person who \"normally pursues an activity as an employed person\" in \"one or more Member States as well as in the United Kingdom\", or in \"two or more Member States\" respectively, shall refer to a person who simultaneously, or in alternation, for the same undertaking or employer or for various undertakings or employers, exercises one or more separate activities in such States. 6. For the purposes of Article SSC.12(1) and (5) of this Protocol, an employed flight crew or cabin crew member normally pursuing air passenger or freight services in two or more States shall be subject to the legislation of the State where the home base, as defined in Article SSC.1 of this Protocol, is located. 7. Marginal activities shall be disregarded for the purposes of determining the applicable legislation under Article SSC.12 of this Protocol. Article SSCI.15 shall apply to all cases under this Article. 8. For the purposes of the application of Article SSC.12(2) and (6) of this Protocol, a person who \"normally pursues an activity as a self-employed person\" in \"one or more Member States as well as in the United Kingdom\", or in \"two or more Member States\" respectively, shall refer, in particular, to a person who simultaneously or in alternation pursues one or more separate self-employed activities, irrespective of the nature of those activities, in such States. 9. For the purposes of distinguishing the activities under paragraphs 5 and 8 of this Article from the situations described in Article SSC.11(1) of this Protocol, the duration of the activity in one or more States (whether it is permanent or of an ad hoc or temporary nature) shall be decisive. For these purposes, an overall assessment shall be made of all the relevant facts including, in particular, in the case of an employed person, the place of work as defined in the employment contract. 10. For the purposes of the application of Article SSC.12(1), (2), (5) and (6) of this Protocol, a \"substantial part of employed or self-employed activity\" pursued in a State shall mean a quantitatively substantial part of all the activities of the employed or self-employed person pursued there, without this necessarily being the major part of those activities. 11. To determine whether a substantial part of the activities is pursued in a State, the following indicative criteria shall be taken into account: (a) in the case of an employed activity, the working time or the remuneration; and (b) in the case of a self-employed activity, the turnover, working time, number of services rendered or income. In the framework of an overall assessment, a share of less than 25 % in respect of the criteria mentioned above shall be an indicator that a substantial part of the activities is not being pursued in the relevant State. 12. For the purposes of the application of point (b) of Article SSC.12(2) of this Protocol, the \"centre of interest\" of the activities of a self-employed person shall be determined by taking account of all the aspects of that person's occupational activities, notably the place where the person's fixed and permanent place of business is located, the habitual nature or the duration of the activities pursued, the number of services rendered, and the intention of the person concerned as revealed by all the circumstances. 13. For the determination of the applicable legislation under paragraphs 10, 11 and 12, the institutions concerned shall take into account the situation projected for the following 12 calendar months. 14. If a person pursues his or her activity as an employed person in two or more States on behalf of an employer established outside the territory of the States, and if this person resides in a State without pursuing substantial activity there, they shall be subject to the legislation of the State of residence. Article SSCI.14 Procedures for the application of point (b) of Article SSC.10(3), Article SSC.10(4) and Article SSC.11 of this Protocol (on the provision of information to the institutions concerned) 1. Unless otherwise provided for by Article SSCI.15 of this Annex, where a person pursues their activity outside the competent State, the employer or, in the case of a person who does not pursue an activity as an employed person, the person concerned shall inform the competent institution of the State whose legislation is applicable thereof, whenever possible in advance. That institution shall issue the attestation referred to in Article SSCI.16(2) of this Annex to the person concerned and shall without delay make information concerning the legislation applicable to that person, pursuant to point (b) of Article SSC.10(3) or Article SSC.11 of this Protocol, available to the institution designated by the competent authority of the State in which the activity is pursued. 2. An employer within the meaning of Article SSC.10(4) of this Protocol who has an employee on board a vessel flying the flag of another State shall inform the competent institution of the State whose legislation is applicable thereof whenever possible in advance. That institution shall, without delay, make information concerning the legislation applicable to the person concerned, pursuant to Article SSC.10(4) of this Protocol, available to the institution designated by the competent authority of the State whose flag, the vessel on which the employee is to perform the activity, is flying. Article SSCI.15 Procedure for the application of Article SSC.12 of this Protocol 1. A person who pursues activities in two or more States, or where Article SSC.12(5) or (6) applies, shall inform the institution designated by the competent authority of the State of residence thereof. 2. The designated institution of the place of residence shall without delay determine the legislation applicable to the person concerned, having regard to Article SSC.12 of this Protocol and Article SSCI.13 of this Annex. That initial determination shall be provisional. The institution shall inform the designated institutions of each State in which an activity is pursued of its provisional determination. 3. The provisional determination of the applicable legislation, as provided for in paragraph 2, shall become definitive within two months of the institutions designated by the competent authorities of the State(s) concerned being informed of it, in accordance with paragraph 2, unless the legislation has already been definitively determined on the basis of paragraph 4, or at least one of the institutions concerned informs the institution designated by the competent authority of the State of residence by the end of this two-month period that it cannot yet accept the determination or that it takes a different view on this. 4. Where uncertainty about the determination of the applicable legislation requires contacts between the institutions or authorities of two or more States, at the request of one or more of the institutions designated by the competent authorities of the State(s) concerned, or of the competent authorities themselves, the legislation applicable to the person concerned shall be determined by common agreement, having regard to Article SSC.12 of this Protocol and the relevant provisions of Article SSCI.13 of this Annex. Where there is a difference of views between the institutions or competent authorities concerned, those bodies shall seek agreement in accordance with the conditions set out above and Article SSCI.6 shall apply. 5. The competent institution of the State whose legislation is determined to be applicable either provisionally or definitively shall without delay inform the person concerned. 6. If the person concerned fails to provide the information referred to in paragraph 1, this Article shall be applied at the initiative of the institution designated by the competent authority of the State of residence as soon as it is appraised of that person's situation, possibly via another institution concerned. Article SSCI.16 Provision of information to persons concerned and employers 1. The competent institution of the State whose legislation becomes applicable pursuant to Title II of this Protocol shall inform the person concerned and, where appropriate, their employer(s) of the obligations laid down in that legislation. It shall provide them with the necessary assistance to complete the formalities required by that legislation. 2. At the request of the person concerned or of the employer, the competent institution of the State whose legislation is applicable pursuant to Title II shall provide an attestation that such legislation is applicable and shall indicate, where appropriate, until what date and under what conditions. Article SSCI.17 Cooperation between institutions 1. The relevant institutions shall communicate to the competent institution of the State whose legislation is applicable to a person pursuant to Title II of this Protocol the necessary information required to establish the date on which that legislation becomes applicable and the contributions which that person and his or her employer(s) are liable to pay under that legislation. 2. The competent institution of the State whose legislation becomes applicable to a person pursuant to Title II of this Protocol shall make the information indicating the date on which the application of that legislation takes effect available to the institution designated by the competent authority of the State to whose legislation that person was last subject. Article SSCI.18 Cooperation in case of doubts about the validity of issued documents concerning the applicable legislation 1. Where there is doubt about the validity of a document showing the position of the person for the purposes of the applicable legislation or the accuracy of the facts on which the document is based, the institution of the State that receives the document shall ask the issuing institution for the necessary clarification and, where appropriate, the withdrawal or rectification of that document. The requesting institution shall substantiate its request and provide the relevant supporting documentation that gave rise to the request. 2. When receiving such a request, the issuing institution shall reconsider the grounds for issuing the document and, where an error is detected, withdraw it or rectify it within 30 working days from the receipt of the request. The withdrawal or rectification shall have retroactive effect. However, in cases where there is a risk of disproportionate outcome, and in particular, of the loss of status as an insured person for the whole or part of the relevant period in the State(s) concerned, the States shall consider a more proportionate arrangement in such case. When the available evidence permits the issuing institution to find that the applicant of the document has committed fraud, it shall withdraw or rectify the document without delay and with retroactive effect. TITLE III SPECIAL PROVISIONS CONCERNING THE VARIOUS CATEGORIES OF BENEFITS CHAPTER 1 SICKNESS, MATERNITY AND EQUIVALENT PATERNITY BENEFITS Article SSCI.19 General implementing provisions 1. The competent authorities or institutions shall ensure that any necessary information is made available to insured persons regarding the procedures and conditions for the granting of benefits in kind where such benefits are received in the territory of a State other than that of the competent institution. 2. Notwithstanding point (a) of Article SSC.6 of this Protocol, a State may become responsible for the cost of benefits in accordance with Article SSC.20 of this Protocol only if, either the insured person has made a claim for a pension under the legislation of that State, or in accordance with Articles SSC.21 to SSC.27 of this Protocol, they receive a pension under the legislation of that State. Article SSCI.20 Regime applicable in the event of the existence of more than one regime in the State of residence or stay If the legislation of the State of residence or stay comprises more than one scheme of sickness, maternity and paternity insurance for more than one category of insured persons, the provisions applicable under Articles SSC.15, SSC.17(1), SSC.18, SSC.20, SSC.22 and SSC.24 of this Protocol shall be those of the legislation on the general scheme for employed persons. Article SSCI.21 Residence in a State other than the competent State Procedure and scope of right 1. For the purposes of the application of Article SSC.15 of this Protocol, the insured person or members of that person's family shall be obliged to register promptly with the institution of the place of residence. Their right to benefits in kind in the State of residence shall be certified by a document issued by the competent institution upon request of the insured person or upon request of the institution of the place of residence. 2. The document referred to in paragraph 1 shall remain valid until the competent institution informs the institution of the place of residence of its cancellation. The institution of the place of residence shall inform the competent institution of any registration under paragraph 1 and of any change or cancellation of that registration. 3. This Article applies mutatis mutandis to the persons referred to in Articles SSC.20, SSC.22, SSC.23 and SSC.24 of this Protocol. Reimbursement 4. Where a person or the members of that person's family: (a) have been issued with the document referred to in paragraph 1; (b) have registered that document with the institution of the place of residence in accordance with paragraph 1; and (c) a health fee has been paid by or on behalf of the person or members of their family to the State of residence as part of an application for a permit to enter, stay, work or reside in that State, that person or members of that person's family may apply to the institution of the State of residence for reimbursement (in whole or part, as the case may be) of the health fee paid. 5. Where a claim is made in accordance with paragraph 1, the institution of the State of residence shall determine that claim within three calendar months, starting on the day the claim was received, and shall make any reimbursement in accordance with this Article. 6. Where the period of validity of the document referred to in paragraph 1 is less than the period of time in respect of which the health fee has been paid, the amount reimbursed shall not exceed that portion of the health fee which corresponds to the period for which the document had been issued. 7. Where the health fee was paid by another person on behalf of a person to whom this Article applies, reimbursement may be made to that other person. Article SSCI.22 Stay in a State other than the competent State Procedure and scope of right 1. For the purposes of the application of Article SSC.17 of this Protocol, the insured person shall present to the health care provider in the State of stay an entitlement document issued by the competent institution indicating his entitlement to benefits in kind. If the insured person does not have such a document, the institution of the place of stay, upon request or if otherwise necessary, shall contact the competent institution in order to obtain one. 2. That document shall indicate that the insured person is entitled to benefits in kind under the conditions laid down in Article SSC.17 of this Protocol on the same terms as those applicable to persons insured under the legislation of the State of stay, and shall satisfy the requirements in Appendix SSCI-2. 3. The benefits in kind referred to in Article SSC.17(1) of this Protocol shall refer to the benefits in kind which are provided in the State of stay, in accordance with its legislation, and which become necessary on medical grounds with a view to preventing an insured person from being forced to return, before the end of the planned duration of stay, to the competent State to obtain the necessary treatment. Procedure and arrangements for meeting the costs and providing reimbursement of benefits in kind 4. If the insured person has actually borne the costs of all or part of the benefits in kind provided within the framework of Article SSC.17 of this Protocol and if the legislation applied by the institution of the place of stay enables reimbursement of those costs to an insured person, they may send an application for reimbursement to the institution of the place of stay. In that case, that institution shall reimburse directly to that person the amount of the costs corresponding to those benefits within the limits of and under the conditions of the reimbursement rates laid down in its legislation. 5. If the reimbursement of such costs has not been requested directly from the institution of the place of stay, the costs incurred shall be reimbursed to the person concerned by the competent institution in accordance with the reimbursement rates administered by the institution of the place of stay or the amounts which would have been subject to reimbursement to the institution of the place of stay, if Article SSCI.47 had applied in the case concerned. The institution of the place of stay shall provide the competent institution, upon request, with all necessary information about these rates or amounts. 6. By way of derogation from paragraph 5, the competent institution may undertake the reimbursement of the costs incurred within the limits of and under the conditions of the reimbursement rates laid down in its legislation, provided that the insured person has agreed to this provision being applied to them. 7. If the legislation of the State of stay does not provide for reimbursement pursuant to paragraphs 4 and 5 in the case concerned, the competent institution may reimburse the costs within the limits of and under the conditions of the reimbursement rates laid down in its legislation, without the agreement of the insured person. 8. The reimbursement to the insured person shall not, in any event, exceed the amount of costs actually incurred by them. 9. In the case of substantial expenditure, the competent institution may pay the insured person an appropriate advance as soon as that person submits the application for reimbursement to it. Family Members 10. Paragraphs 1 to 9 apply mutatis mutandis to the members of the family of the insured person. Reimbursement for students 11. Where a person: (a) holds a valid entitlement document referred to in Appendix SSCI-2 issued by the competent institution; (b) has been accepted by a higher education institution in a State other than the competent State (\"State of study\") to pursue a full-time course of study leading to a higher education qualification recognised by that State, including diplomas, certificates or doctoral degrees at a higher education institution, which may cover a preparatory course prior to such education, in accordance with national law, or compulsory training; (c) does not exercise, or has not exercised, an activity as an employed or self-employed person in the State of study during the period to which the health fee relates; and (d) a health fee has been paid by or on behalf of that person to the State of study as part of an application for a permit to enter, stay or reside for the purposes of pursuing a full-time course of study in that State; that person may apply to the institution of the State of study for reimbursement (in whole or part, as the case may be) of the health fee paid. 12. Where a claim is made in accordance with paragraph 11, the institution of the State of study shall process and settle that claim within a reasonable period but not later than six calendar months starting on the day the claim was received and make any reimbursement in accordance with this Article. 13. Where the period of validity of the entitlement document referred to in point (a) of paragraph 11 is less than the period of time in respect of which the health fee has been paid, the amount of the health fee reimbursed shall be the amount paid which corresponds to the period of validity of that document. 14. Where the health fee was paid by another person on behalf of a person to whom this Article applies, reimbursement may be made to that other person. 15. Paragraphs 11 to 14 apply mutatis mutandis to the members of the family of that person. 16. This Article shall enter into force 12 months after the date of entry into force of this Agreement. 17. A person who satisfied the conditions in paragraph 11 in the period between the entry into force of this Agreement and the date specified in paragraph 16 may, upon the entry into force of this Article, make a claim for reimbursement under paragraph 11 in relation to that period. 18. By way of derogation from Article SSC.5(1), charges may be imposed by the State of study in accordance with its national law in respect of benefits in kind that do not fulfil the criteria set out in point (a) of Article SSC.17(1) and which are provided to a person in respect of whom reimbursement has been made during that person's stay for the period to which that reimbursement relates. Article SSCI.23 Scheduled treatment Authorisation procedure 1. For the purposes of the application of Article SSC.18(1) of this Protocol, the insured person shall present a document issued by the competent institution to the institution of the place of stay. For the purposes of this Article, the competent institution shall mean the institution which bears the cost of the scheduled treatment; in the cases referred to in Articles SSC.18(4) and SSC.25(5) of this Protocol, in which the benefits in kind provided in the State of residence are reimbursed on the basis of fixed amounts, the competent institution shall mean the institution of the place of residence. 2. If an insured person does not reside in the competent State, they shall request authorisation from the institution of the place of residence, which shall forward it to the competent institution without delay. In that event, the institution of the place of residence shall certify in a statement whether the conditions set out in the second sentence of Article SSC.18(2) of this Protocol are met in the State of residence. The competent institution may refuse to grant the requested authorisation only if, in accordance with the assessment of the institution of the place of residence, the conditions set out in the second sentence of Article SSC.18(2) of this Protocol are not met in the State of residence of the insured person, or if the same treatment can be provided in the competent State itself, within a time-limit which is medically justifiable, taking into account the current state of health and the probable course of illness of the person concerned. The competent institution shall inform the institution of the place of residence of its decision. In the absence of a reply within the deadlines set by its national legislation, the authorisation shall be considered to have been granted by the competent institution. 3. If an insured person who does not reside in the competent Party is in need of urgent vitally necessary treatment, and the authorisation cannot be refused in accordance with the second sentence of Article SSC.18(2) of this Protocol, the authorisation shall be granted by the institution of the place of residence on behalf of the competent institution, which shall be immediately informed by the institution of the place of residence. The competent institution shall accept the findings and the treatment options of the doctors approved by the institution of the place of residence that issues the authorisation, concerning the need for urgent vitally necessary treatment. 4. At any time during the procedure granting the authorisation, the competent institution shall retain the right to have the insured person examined by a doctor of its own choice in the Party of stay or residence. 5. The institution of the place of stay shall, without prejudice to any decision regarding authorisation, inform the competent institution if it appears medically appropriate to supplement the treatment covered by the existing authorisation. Meeting the cost of benefits in kind incurred by the insured person 6. Without prejudice to paragraph 7, Article SSCI.22(4) and (5) apply mutatis mutandis. 7. If the insured person has actually borne all or part of the costs for the authorised medical treatment themselves and the costs which the competent institution is obliged to reimburse to the institution of the place of stay or to the insured person according to paragraph 6 (actual cost) are lower than the costs which it would have had to assume for the same treatment in the competent State (notional cost), the competent institution shall reimburse, upon request, the cost of treatment incurred by the insured person up to the amount by which the notional cost exceeds the actual cost. The reimbursed sum may not, however, exceed the costs actually incurred by the insured person and may take account of the amount which the insured person would have had to pay if the treatment had been delivered in the competent State. Meeting the costs of travel and stay as part of scheduled treatment 8. Where the national legislation of the competent institution provides for the reimbursement of the costs of travel and stay which are inseparable from the treatment of the insured person, such costs for the person concerned and, if necessary, for a person who must accompany them, shall be assumed by this institution when an authorisation is granted in the case of treatment in another State. Family members 9. Paragraphs 1 to 8 apply mutatis mutandis to the members of the family of the insured person. Article SSCI.24 Cash benefits relating to incapacity for work in the event of stay or residence in a State other than the competent State Procedure to be followed by the insured person 1. If the legislation of the competent State requires that the insured person presents a certificate in order to be entitled to cash benefits relating to incapacity for work pursuant to Article SSC.19(1) of this Protocol, the insured person shall ask the doctor of the State of residence who established that person's state of health to certify his or her incapacity for work and its probable duration. 2. The insured person shall send the certificate to the competent institution within the time limit laid down by the legislation of the competent State. 3. Where the doctors providing treatment in the State of residence do not issue certificates of incapacity for work, and where such certificates are required under the legislation of the competent State, the person concerned shall apply directly to the institution of the place of residence. That institution shall immediately arrange for a medical assessment of the person's incapacity for work and for the certificate referred to in paragraph 1 to be drawn up. The certificate shall be forwarded to the competent institution forthwith. 4. The forwarding of the document referred to in paragraphs 1, 2 and 3 shall not exempt the insured person from fulfilling the obligations provided for by the applicable legislation, in particular with regard to that person's employer. Where appropriate, the employer or the competent institution may call upon the employee to participate in activities designed to promote and assist his or her return to employment. Procedure to be followed by the institution of the State of residence 5. At the request of the competent institution, the institution of the place of residence shall carry out any necessary administrative checks or medical examinations of the person concerned in accordance with the legislation applied by this latter institution. The report of the examining doctor concerning, in particular, the probable duration of the incapacity for work, shall be forwarded without delay by the institution of the place of residence to the competent institution. Procedure to be followed by the competent institution 6. The competent institution shall reserve the right to have the insured person examined by a doctor of its choice. 7. Without prejudice to the second sentence of Article SSC.19(1) of this Protocol, the competent institution shall pay the cash benefits directly to the person concerned and shall, where necessary, inform the institution of the place of residence thereof. 8. For the purposes of the application of Article SSC.19(1) of this Protocol, the particulars of the certificate of incapacity for work of an insured person drawn up in another State on the basis of the medical findings of the examining doctor or institution shall have the same legal value as a certificate drawn up in the competent State. 9. If the competent institution refuses the cash benefits, it shall notify its decision to the insured person and at the same time to the institution of the place of residence. Procedure in the event of a stay in a State other than the competent State 10. Paragraphs 1 to 9 apply mutatis mutandis when the insured person stays in a State other than the competent State. Article SSCI.25 Contributions by pensioners If a person receives a pension from more than one State, the amount of contributions deducted from all the pensions paid shall, under no circumstances, be greater than the amount deducted in respect of a person who receives the same amount of pension from the competent State. Article SSCI.26 Special implementing measures 1. When a person or a group of persons are exempted upon request from compulsory sickness insurance and such persons are thus not covered by a sickness insurance scheme to which this Protocol applies, the institution of a State shall not, solely because of this exemption, become responsible for bearing the costs of benefits in kind or in cash provided to such persons or to a member of their family under Articles SSC.15 to SSC.30 of this Protocol. 2. When the persons referred to in paragraph 1 and the members of their families reside in a State where the right to receive benefits in kind is not subject to conditions of insurance, or of activity as an employed or self-employed person, they shall be liable to pay the full costs of benefits in kind provided in their State of residence. CHAPTER 2 BENEFITS IN RESPECT OF ACCIDENTS AT WORK AND OCCUPATIONAL DISEASES Article SSCI.27 Right to benefits in kind and in cash in the event of residence or stay in a State other than the competent State 1. For the purposes of the application of Article SSC.31 of this Protocol, the procedures laid down in Articles SSCI.21 to SSCI.24 of this Annex apply mutatis mutandis. 2. When providing special benefits in kind in connection with accidents at work and occupational diseases under the national legislation of the State of stay or residence, the institution of that State shall without delay inform the competent institution. Article SSCI.28 Procedure in the event of an accident at work or occupational disease which occurs in a State other than the competent State 1. If an accident at work occurs or an occupational disease is diagnosed for the first time in a State other than the competent State, the declaration or notification of the accident at work or the occupational disease, where the declaration or notification exists under national legislation, shall be carried out in accordance with the legislation of the competent State, without prejudice, where appropriate, to any other applicable legal provisions in force in the State in which the accident at work occurred or in which the first medical diagnosis of the occupational disease was made, which remain applicable in such cases. The declaration or notification shall be addressed to the competent institution. 2. The institution of the State in the territory of which the accident at work occurred or in which the occupational disease was first diagnosed, shall notify the competent institution of medical certificates drawn up in the territory of that State. 3. Where, as a result of an accident while travelling to or from work which occurs in the territory of a State other than the competent State, an inquiry is necessary in the territory of the first State in order to determine any entitlement to relevant benefits, a person may be appointed for that purpose by the competent institution, which shall inform the authorities of that State. The institutions shall cooperate with each other in order to assess all relevant information and to consult the reports and any other documents relating to the accident. 4. Following treatment, a detailed report accompanied by medical certificates relating to the permanent consequences of the accident or disease, in particular the injured person's present state and the recovery or stabilisation of injuries, shall be sent upon request of the competent institution. The relevant fees shall be paid by the institution of the place of residence or of stay, where appropriate, at the rate applied by that institution to the charge of the competent institution. 5. At the request of the institution of the place of residence or stay, where appropriate, the competent institution shall notify it of the decision setting the date for the recovery or stabilisation of injuries and, where appropriate, the decision concerning the granting of a pension. Article SSCI.29 Disputes concerning the occupational nature of the accident or disease 1. Where the competent institution disputes the application of the legislation relating to accidents at work or occupational diseases under Article SSC.31(2) of this Protocol, it shall without delay inform the institution of the place of residence or stay which provided the benefits in kind, which will then be considered as sickness insurance benefits. 2. When a final decision has been taken on that subject, the competent institution shall, without delay, inform the institution of the place of residence or stay which provided the benefits in kind. Where an accident at work or occupational disease is not established, benefits in kind shall continue to be provided as sickness benefits if the person concerned is entitled to them. Where an accident at work or occupational disease is established, sickness benefits in kind provided to the person concerned shall be considered as accident at work or occupational disease benefits from the date on which the accident at work occurred or the occupational disease was first medically diagnosed. 3. The second subparagraph of Article SSCI.6(5) applies mutatis mutandis. Article SSCI.30 Procedure in the event of exposure to the risk of an occupational disease in two or more States 1. In the case referred to in Article SSC.33 of this Protocol, the declaration or notification of the occupational disease shall be sent to the competent institution for occupational diseases of the last State under the legislation of which the person concerned pursued an activity likely to cause that disease. When the institution to which the declaration or notification was sent establishes that an activity likely to cause the occupational disease in question was last pursued under the legislation of another State, it shall send the declaration or notification and all accompanying certificates to the equivalent institution in that State. 2. Where the institution of the last State under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question establishes that the person concerned or his survivors do not meet the requirements of that legislation, inter alia, because the person concerned had never pursued in that State an activity which caused the occupational disease or because that State does not recognise the occupational nature of the disease, that institution shall forward without delay the declaration or notification and all accompanying certificates, including the findings and reports of medical examinations performed by the first institution to the institution of the previous State under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question. 3. Where appropriate, the institutions shall reiterate the procedure set out in paragraph 2 going back as far as the equivalent institution in the State under whose legislation the person concerned first pursued an activity likely to cause the occupational disease in question. Article SSCI.31 Exchange of information between institutions and advance payments in the event of an appeal against rejection 1. In the event of an appeal against a decision to refuse benefits taken by the institution of a State under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question, that institution shall inform the institution to which the declaration or notification was sent, in accordance with the procedure provided for in Article SSCI.30(2), and shall subsequently inform it when a final decision is reached. 2. Where a person is entitled to benefits under the legislation applied by the institution to which the declaration or notification was sent, that institution shall make the advance payments, the amount of which shall be determined, where appropriate, after consulting the institution which made the decision against which the appeal was lodged, and in such a way that overpayments are avoided. The latter institution shall reimburse the advance payments made if, as a result of the appeal, it is obliged to provide those benefits. That amount will then be deducted from the benefits due to the person concerned, in accordance with the procedure provided for in Articles SSCI.56 and SSCI.57. 3. The second subparagraph of Article SSCI.6(5) applies mutatis mutandis. Article SSCI.32 Aggravation of an occupational disease In the cases covered by Article SSC.34 of this Protocol, the claimant must provide the institution in the State from which they are claiming entitlement to benefits with details concerning benefits previously granted for the occupational disease in question. That institution may contact any other previously competent institution in order to obtain the information it considers necessary. Article SSCI.33 Assessment of the degree of incapacity in the event of occupational accidents or diseases which occurred previously or subsequently Where a previous or subsequent incapacity for work was caused by an accident which occurred when the person concerned was subject to the legislation of a State which makes no distinction according to the origin of the incapacity to work, the competent institution or the body designated by the competent authority of the State in question shall: (a) upon request by the competent institution of another State, provide information concerning the degree of the previous or subsequent incapacity for work, and where possible, information making it possible to determine whether the incapacity is the result of an accident at work within the meaning of the legislation applied by the institution in the other State; (b) take into account the degree of incapacity caused by these previous or subsequent cases when determining the right to benefits and the amount, in accordance with the applicable legislation. Article SSCI.34 Submission and investigation of claims for pensions or supplementary allowances In order to receive a pension or supplementary allowance under the legislation of a State, the person concerned or their survivors residing in the territory of another State shall submit, where appropriate, a claim either to the competent institution or to the institution of the place of residence, which shall send it to the competent institution. The claim shall contain the information required under the legislation applied by the competent institution. CHAPTER 3 DEATH GRANTS Article SSCI.35 Claim for death grants For the purposes of Articles SSC.37 and SSC.38 of this Protocol, the claim for death grants shall be sent either to the competent institution or to the institution of the claimant's place of residence, which shall send it to the competent institution. The claim shall contain the information required under the legislation applied by the competent institution. CHAPTER 4 INVALIDITY BENEFITS AND OLD-AGE AND SURVIVORS' PENSIONS Article SSCI.36 Additional provisions for the calculation of the benefit 1. For the purposes of calculating the theoretical amount and the actual amount of the benefit in accordance with point (b) of Article SSC.47(1) of this Protocol, the rules provided for in Article SSCI.11(3), (4), (5) and (6) of this Annex apply. 2. Where periods of voluntary or optional continued insurance have not been taken into account under Article SSCI.11(3) of this Annex, the institution of the State under whose legislation those periods were completed shall calculate the amount corresponding to those periods under the legislation it applies. The actual amount of the benefit, calculated in accordance with point (b) of Article SSC.47(1) of this Protocol, shall be increased by the amount corresponding to periods of voluntary or optional continued insurance. 3. The institution of each State shall calculate, under the legislation it applies, the amount due corresponding to periods of voluntary or optional continued insurance which, under point (c) of Article SSC.48(3) of this Protocol, shall not be subject to the another State's rules relating to withdrawal, reduction or suspension. Where the legislation applied by the competent institution does not allow it to determine this amount directly, on the grounds that that legislation allocates different values to insurance periods, a notional amount may be established. The Specialised Committee on Social Security Coordination shall lay down the detailed arrangements for the determination of that notional amount. Article SSCI.37 Claims for benefits Submission of claims for old-age and survivors' pensions 1. The claimant shall submit a claim to the institution of his place of residence or to the institution of the last State whose legislation was applicable. If the person concerned was not, at any time, subject to the legislation applied by the institution of the place of residence, that institution shall forward the claim to the institution of the last State whose legislation was applicable. 2. The date of submission of the claim shall apply in all the institutions concerned. 3. By way of derogation from paragraph 2, if the claimant does not, despite having been asked to do so, notify the fact that he or she has been employed or has resided in other States, the date on which the claimant completes his or her initial claim or submits a new claim for his or her missing periods of employment or/and residence in a State shall be considered as the date of submission of the claim to the institution applying the legislation in question, subject to more favourable provisions of that legislation. Article SSCI.38 Certificates and information to be submitted with the claim by the claimant 1. The claim shall be submitted by the claimant in accordance with the provisions of the legislation applied by the institution referred to in Article SSCI.37(1) and be accompanied by the supporting documents required by that legislation. In particular, the claimant shall supply all available relevant information and supporting documents relating to periods of insurance (institutions, identification numbers), employment (employers) or self-employment (nature and place of activity) and residence (addresses) which may have been completed under other legislation, as well as the length of those periods. 2. Where, in accordance with Article SSC.45(1) of this Protocol, the claimant requests deferment of the award of old-age benefits under the legislation of one or more States, the claimant shall state that in their claim and specify under which legislation the deferment is requested. In order to enable the claimant to exercise that right, the institutions concerned shall, upon the request of the claimant, notify them of all the information available to them so that he or she can assess the consequences of concurrent or successive awards of benefits which they might claim. 3. Should the claimant withdraw a claim for benefits provided for under the legislation of a particular State, that withdrawal shall not be considered as a concurrent withdrawal of claims for benefits under the legislation of another State. Article SSCI.39 Investigation of claims by the institutions concerned Contact institution 1. The institution to which the claim for benefits is submitted or forwarded in accordance with Article SSCI.37(1) shall be referred to hereinafter as the \"contact institution\". The institution of the place of residence shall not be referred to as the contact institution if the person concerned has not, at any time, been subject to the legislation which that institution applies. In addition to investigating the claim for benefits under the legislation which it applies, that institution shall, in its capacity as contact institution, promote the exchange of data, the communication of decisions and the operations necessary for the investigation of the claim by the institutions concerned, and supply the claimant, upon request, with any information relevant to the aspects of the investigation which arise under this Protocol, and keep the claimant informed of its progress. Investigation of claims for old-age and survivors pensions 2. The contact institution shall, without delay, send claims for benefits and all the documents which it has available and, where appropriate, the relevant documents supplied by the claimant to all the institutions in question so that they can all start the investigation of the claim concurrently. The contact institution shall notify the other institutions of periods of insurance or residence subject to its legislation. It shall also indicate which documents shall be submitted at a later date and supplement the claim as soon as possible. 3. Each of the institutions in question shall notify the contact institution and the other institutions in question, as soon as possible, of the periods of insurance or residence subject to their legislation. 4. Each of the institutions in question shall calculate the amount of benefits in accordance with Article SSC.47 of this Protocol and shall notify the contact institution and the other institutions concerned of its decision, of the amount of benefits due and of any information required for the purposes of Articles SSC.48 to SSC.50 of this Protocol. 5. Should an institution establish, on the basis of the information referred to in paragraphs 2 and 3 of this Article, that Article SSC.52(2) or (3) of this Protocol is applicable, it shall inform the contact institution and the other institutions concerned. Article SSCI.40 Notification of decisions to the claimant 1. Each institution shall notify the claimant of the decision it has taken in accordance with the applicable legislation. Each decision shall specify the remedies and periods allowed for appeals. Once the contact institution has been notified of all decisions taken by each institution, it shall send the claimant and the other institutions concerned a summary of those decisions. A model summary shall be drawn up by the Specialised Committee on Social Security Coordination. The summary shall be sent to the claimant in the language of the institution or, at the request of the claimant, in any language of their choice, including English, recognised as an official language of the Union. 2. Where it appears to the claimant following receipt of the summary that his or her rights may have been adversely affected by the interaction of decisions taken by two or more institutions, the claimant shall have the right to a review of the decisions by the institutions concerned within the time limits laid down in the respective national legislation. The time limits shall commence on the date of receipt of the summary. The claimant shall be notified of the result of the review in writing. Article SSCI.41 Determination of the degree of invalidity Each institution shall, in accordance with its legislation, have the possibility of having the claimant examined by a medical doctor or other expert of its choice to determine the degree of invalidity. However, the institution of a State shall take into consideration documents, medical reports and administrative information collected by the institution of any other State as if they had been drawn up in its own territory. Article SSCI.42 Provisional instalments and advance payment of a benefit 1. Notwithstanding Article SSCI.7 of this Annex, any institution which establishes, while investigating a claim for benefits, that the claimant is entitled to an independent benefit under the applicable legislation, in accordance with point (a) of Article SSC.47(1) of this Protocol, shall pay that benefit without delay. That payment shall be considered provisional if the amount might be affected by the result of the claim investigation procedure. 2. Whenever it is evident from the information available that the claimant is entitled to a payment from an institution under point (b) of Article SSC.47(1) of this Protocol, that institution shall make an advance payment, the amount of which shall be as close as possible to the amount which will probably be paid under point (b) of Article SSC.47(1) of this Protocol. 3. Each institution which is obliged to pay the provisional benefits or advance payment under paragraph 1 or 2 shall inform the claimant without delay, specifically drawing the claimant's attention to the provisional nature of the measure and any rights of appeal in accordance with its legislation. Article SSCI.43 New calculation of benefits 1. Where there is a new calculation of benefits in accordance with Articles SSC.45(4) and SSC.54(1) of this Protocol, Article SSCI.42 of this Annex shall be applicable mutatis mutandis. 2. Where there is a new calculation, withdrawal or suspension of the benefit, the institution which took the decision shall inform the person concerned without delay and shall inform each of the institutions in respect of which the person concerned has an entitlement. Article SSCI.44 Measures intended to accelerate the pension calculation process 1. In order to facilitate and accelerate the investigation of claims and the payment of benefits, the institutions to whose legislation a person has been subject shall: (a) exchange with or make available to institutions of other States the elements for identifying persons who change from one applicable national legislation to another, and together ensure that those identification elements are retained and correspond, or, failing that, provide those persons with the means to access their identification elements directly; (b) sufficiently in advance of the minimum age for commencing pension rights or before an age to be determined by national legislation, exchange with or make available to the person concerned and to institutions of other States information (periods completed or other important elements) on the pension entitlements of persons who have changed from one applicable legislation to another or, failing that, inform those persons of, or provide them with, the means of familiarising themselves with their prospective benefit entitlement. 2. For the purposes of paragraph 1, the Specialised Committee on Social Security Coordination shall determine the elements of information to be exchanged or made available and shall establish the appropriate procedures and mechanisms, taking account of the characteristics, administrative and technical organisation, and the technological means at the disposal of national pension schemes. The Specialised Committee on Social Security Coordination shall ensure the implementation of those pension schemes by organising a follow-up to the measures taken and their application. 3. For the purposes of paragraph 1, the institution in the first State where a person is allocated a Personal Identification Number (PIN) for the purposes of social security administration should be provided with the information referred to in this Article. Article SSCI.45 Coordination measures in the States 1. Without prejudice to Article SSC.46 of this Protocol, where national legislation includes rules for determining the institution responsible or the scheme applicable or for designating periods of insurance to a specific scheme, those rules shall be applied, taking into account only periods of insurance completed under the legislation of the State concerned. 2. Where national legislation includes rules for the coordination of special schemes for civil servants and the general scheme for employed persons, those rules shall not be affected by the provisions of this Protocol and of this Annex. CHAPTER 5 UNEMPLOYMENT BENEFITS Article SSCI.46 Aggregation of periods and calculation of benefits 1. Article SSCI.11(1) of this Annex applies mutatis mutandis to Article SSC.56 of this Protocol. Without prejudice to the underlying obligations of the institutions involved, the person concerned may submit to the competent institution a document issued by the institution of the State to whose legislation they were subject in respect of that person's last activity as an employed or self-employed person specifying the periods completed under that legislation. 2. For the purpose of applying Article SSC.57 of this Protocol, the competent institution of a State whose legislation provides that the calculation of benefits varies with the number of members of the family shall also take into account the members of the family of the person concerned residing in another State as if they resided in the competent State. This provision shall not apply where, in the State of residence of members of the family, another person is entitled to unemployment benefits calculated on the basis of the number of members of the family. TITLE IV FINANCIAL PROVISIONS CHAPTER 1 REIMBURSEMENT OF THE COST OF BENEFITS IN APPLICATION OF ARTICLE SSC.30 AND ARTICLE SSC.36 OF THIS PROTOCOL SECTION 1 REIMBURSEMENT ON THE BASIS OF ACTUAL EXPENDITURE Article SSCI.47 Principles 1. For the purpose of applying Article SSC.30 and Article SSC.36 of this Protocol, the actual amount of the expenses for benefits in kind, as shown in the accounts of the institution that provided them, shall be reimbursed to that institution by the competent institution, except where Article SSCI.57 of this Annex is applicable. 2. If any or part of the actual amount of the expenses for benefits referred to in paragraph 1 is not shown in the accounts of the institution that provided them, the amount to be refunded shall be determined on the basis of a lump-sum payment calculated from all the appropriate references obtained from the data available. The Specialised Committee on Social Security Coordination shall assess the bases to be used for calculation of the lump-sum payment and shall decide the amount thereof. 3. Higher rates than those applicable to the benefits in kind provided to insured persons subject to the legislation applied by the institution providing the benefits referred to in paragraph 1 may not be taken into account in the reimbursement. SECTION 2 REIMBURSEMENT ON THE BASIS OF FIXED AMOUNTS Article SSCI.48 Identification of the State(s) concerned 1. The States referred to in Article SSC.30(2) of this Protocol, whose legal or administrative structures are such that the use of reimbursement on the basis of actual expenditure is not appropriate, are listed in Appendix SSCI-3 to this Annex. 2. In the case of the States listed in Appendix SSCI-3, the amount of benefits in kind supplied to: (a) family members who do not reside in the same State as the insured person, as provided for in Article SSC.15 of this Protocol; and to (b) pensioners and members of their family, as provided for in Article SSC.22(1), Articles SSC.23 and SSC.24 of this Protocol; shall be reimbursed by the competent institutions to the institutions providing those benefits, on the basis of a fixed amount established for each calendar year. This fixed amount shall be as close as possible to actual expenditure. Article SSCI.49 Calculation method of the monthly fixed amounts and the total fixed amount 1. For each creditor State, the monthly fixed amount per person (Fi) for a calendar year shall be determined by dividing the annual average cost per person (Yi), broken down by age group (i), by 12 and by applying a reduction (X) to the result in accordance with the following formula: Fi = Yi*1/12*(1-X) Where: \u2014 the index (i = 1, 2 and 3) represents the three age groups used for calculating the fixed amounts: \u2014 i = 1: persons aged under 20, \u2014 i = 2: persons aged from 20 to 64, \u2014 i = 3: persons aged 65 and over, \u2014 Yi represents the annual average cost per person in age group i, as defined in paragraph 2, \u2014 the coefficient X (0.20 or 0.15) represents the reduction as defined in paragraph 3. 2. The annual average cost per person (Yi) in age group i shall be obtained by dividing the annual expenditure on all benefits in kind provided by the institutions of the creditor State to all persons in the age group concerned subject to its legislation and residing within its territory by the average number of persons concerned in that age group in the calendar year in question. The calculation shall be based on the expenditure under the schemes referred to in Article SSCI.20. 3. The reduction to be applied to the monthly fixed amount shall, in principle, be equal to 20 % (X = 0.20). It shall be equal to 15 % (X = 0.15) for pensioners and members of their family where the competent State is not listed in Annex SSC-3 to this Protocol. 4. For each debtor State, the total fixed amount for a calendar year shall be the sum of the products obtained by multiplying, in each age group i, the determined monthly fixed amounts per person by the number of months completed by the persons concerned in the creditor State in that age group. The number of months completed by the persons concerned in the creditor State shall be the sum of the calendar months in a calendar year during which the persons concerned were, because of their residence in the territory of the creditor State, eligible to receive benefits in kind in that territory at the expense of the debtor State. Those months shall be determined from an inventory kept for that purpose by the institution of the place of residence, based on documentary evidence of the entitlement of the beneficiaries supplied by the competent institution. 5. The Specialised Committee on Social Security Coordination may present a proposal containing any amendments which may prove necessary in order to ensure that the calculation of fixed amounts comes as close as possible to the actual expenditure incurred and the reductions referred to in paragraph 3 do not result in unbalanced payments or double payments for the States. 6. The Specialised Committee on Social Security Coordination shall establish the methods for determining the elements for calculating the fixed amounts referred to in this Article. Article SSCI.50 Notification of annual average costs The annual average cost per person in each age group for a specific year shall be notified to the Specialised Committee on Social Security Coordination at the latest by the end of the second year following the year in question. If the notification is not made by this deadline, the annual average cost per person which the Specialised Committee on Social Security Coordination has last determined for a previous year will be taken. SECTION 3 COMMON PROVISIONS Article SSCI.51 Procedure for reimbursement between institutions 1. Reimbursements between the States shall be made as promptly as possible. Every institution concerned shall be obliged to reimburse claims before the deadlines mentioned in this Section, as soon as it is in a position to do so. A dispute concerning a particular claim shall not hinder the reimbursement of another claim or other claims. 2. The reimbursements between the institutions of the Member States and the United Kingdom, provided for in Articles SSC.30 and SSC.36 of this Protocol, shall be made via the liaison body. There may be a separate liaison body for reimbursements under Article SSC.30 and Article SSC.36 of this Protocol. Article SSCI.52 Deadlines for the introduction and settlement of claims 1. Claims based on actual expenditure shall be introduced to the liaison body of the debtor State within 12 months of the end of the calendar half-year during which those claims were recorded in the accounts of the creditor institution. 2. Claims for fixed amounts for a calendar year shall be introduced to the liaison body of the debtor State within the 12-month period following the month during which the average costs for the year concerned were approved by the Specialised Committee on Social Security Coordination. The inventories referred to Article SSCI.49(4) shall be presented by the end of the year following the reference year. 3. In the case referred to in the second subparagraph of Article SSCI.7(5), the deadline set out in paragraphs 1 and 2 of this Article shall not start before the competent institution has been identified. 4. Claims introduced after the deadlines specified in paragraphs 1 and 2 shall not be considered. 5. The claims shall be paid to the liaison body of the creditor State referred to in Article SSCI.51, by the debtor institution within 18 months of the end of the month during which they were introduced to the liaison body of the debtor State. This does not apply to the claims which the debtor institution has rejected for a relevant reason within that period. 6. Any disputes concerning a claim shall be settled, at the latest, within 36 months following the month in which the claim was introduced. 7. The Specialised Committee on Social Security Coordination shall facilitate the final closing of accounts in cases where a settlement cannot be reached within the period set out in paragraph 6, and, upon a reasoned request by one of the parties in the dispute, shall give its opinion on a dispute within six months following the month in which the matter was referred to it. Article SSCI.53 Interest on late payments and down payments 1. From the end of the 18-month period set out in Article SSCI.52(5), interest can be charged by the creditor institution on outstanding claims, unless the debtor institution has made, within six months of the end of the month during which the claim was introduced, a down payment of at least 90 % of the total claim introduced pursuant to Article SSCI.52(1) or (2). For those parts of the claim not covered by the down payment, interest may be charged only from the end of the 36-month period set out in Article SSCI.52(6). 2. The interest shall be calculated on the basis of the reference rate applied by the financial institution designated for this purpose by the Specialised Committee on Social Security Coordination to its main refinancing operations. The reference rate applicable shall be that in force on the first day of the month on which the payment is due. 3. No liaison body shall be obliged to accept a down payment as provided for in paragraph 1. If however, a liaison body declines such an offer, the creditor institution shall no longer be entitled to charge interest on late payments related to the claims in question other than under the second sentence of paragraph 1. Article SSCI.54 Statement of Annual Accounts 1. The Partnership Council shall establish the claims situation for each calendar year on the basis of the report of the Specialised Committee on Social Security Coordination. To this end, the liaison bodies shall notify the Specialised Committee on Social Security Coordination, by the deadlines and according to the procedures laid down by the latter, of the amount of the claims introduced, settled or contested (creditor position) and the amount of claims received, settled or contested (debtor position). 2. The Partnership Council may perform any appropriate checks on the statistical and accounting data used as the basis for drawing up the annual statement of claims provided for in paragraph 1 in order, in particular, to ensure that they comply with the rules laid down under this Title. CHAPTER 2 RECOVERY OF BENEFITS PROVIDED BUT NOT DUE, RECOVERY OF PROVISIONAL PAYMENTS AND CONTRIBUTIONS, OFFSETTING AND ASSISTANCE WITH RECOVERY SECTION 1 PRINCIPLES Article SSCI.55 Common provisions For the purposes of applying Article SSC.64 of this Protocol and within the framework defined therein, the recovery of claims shall, wherever possible, be by way of offsetting either between the institutions of the Member State concerned and of the United Kingdom, or vis-\u00e0-vis the natural or legal person concerned in accordance with Articles SSCI.56 to SSCI.58 of this Annex. If it is not possible to recover all or any of the claim via this offsetting procedure, the remainder of the amount due shall be recovered in accordance with Articles SSCI.59 to SSCI.69 of this Annex. SECTION 2 OFFSETTING Article SSCI.56 Benefits received unduly 1. If the institution of a State has paid undue benefits to a person, that institution may, within the terms and limits laid down in the legislation it applies, request the institution of the State responsible for paying benefits to the person concerned to deduct the undue amount from arrears or on-going payments owed to the person concerned regardless of the social security branch under which the benefit is paid. The institution of the latter State shall deduct the amount concerned subject to the conditions and limits applying to this kind of offsetting procedure in accordance with the legislation it applies in the same way as if it had made the overpayments itself, and shall transfer the amount deducted to the institution that has paid undue benefits. 2. By way of derogation from paragraph 1, if, when awarding or reviewing benefits in respect of invalidity benefits, old-age and survivors' pensions pursuant to Chapters 3 and 4 of Title III of this Protocol, the institution of a State has paid to a person benefits of undue sum, that institution may request the institution of the State responsible for the payment of corresponding benefits to the person concerned to deduct the amount overpaid from the arrears payable to the person concerned. After the latter institution has informed the institution that has paid an undue sum of these arrears, the institution which has paid the undue sum shall within two months communicate the amount of the undue sum. If the institution which is due to pay arrears receives that communication within the deadline it shall transfer the amount deducted to the institution which has paid undue sums. If the deadline expires, that institution shall without delay pay out the arrears to the person concerned. 3. If a person has received social welfare assistance in one State during a period in which they were entitled to benefits under the legislation of another State, the body which provided the assistance may, if it is legally entitled to reclaim the benefits due to the person concerned, request the institution of any other State responsible for paying benefits in favour of the person concerned to deduct the amount of assistance paid from the amounts which that State pays to the person concerned. This provision applies mutatis mutandis to any family member of a person concerned who has received assistance in the territory of a State during a period in which the insured person was entitled to benefits under the legislation of another State in respect of that family member. The institution of a State which has paid an undue amount of assistance shall send a statement of the amount due to the institution of the other State, which shall then deduct the amount, subject to the conditions and limits laid down for this kind of offsetting procedure in accordance with the legislation it applies, and transfer the amount without delay to the institution that has paid the undue amount. Article SSCI.57 Provisionally paid benefits in cash or contributions 1. For the purposes of applying Article SSCI.6, at the latest three months after the applicable legislation has been determined or the institution responsible for paying the benefits has been identified, the institution which provisionally paid the cash benefits shall draw up a statement of the amount provisionally paid and shall send it to the institution identified as being competent. The institution identified as being competent for paying the benefits shall deduct the amount due in respect of the provisional payment from the arrears of the corresponding benefits it owes to the person concerned and shall without delay transfer the amount deducted to the institution which provisionally paid the cash benefits. If the amount of provisionally paid benefits exceeds the amount of arrears, or if arrears do not exist, the institution identified as being competent shall deduct this amount from ongoing payments subject to the conditions and limits applying to this kind of offsetting procedure under the legislation it applies, and without delay transfer the amount deducted to the institution which provisionally paid the cash benefits. 2. The institution which has provisionally received contributions from a legal or natural person shall not reimburse the amounts in question to the person who paid them until it has ascertained from the institution identified as being competent the sums due to it under Article SSCI.6(4). Upon request of the institution identified as being competent, which shall be made at the latest three months after the applicable legislation has been determined, the institution that has provisionally received contributions shall transfer them to the institution identified as being competent for that period for the purpose of settling the situation concerning the contributions owed by the legal or natural person to it. The contributions transferred shall be retroactively deemed as having been paid to the institution identified as being competent. If the amount of provisionally paid contributions exceeds the amount the legal or natural person owes to the institution identified as being competent, the institution which provisionally received contributions shall reimburse the amount in excess to the legal or natural person concerned. Article SSCI.58 Costs related to offsetting No costs are payable where the debt is recovered via the offsetting procedure provided for in Articles SSCI.56 and SSCI.57. SECTION 3 RECOVERY Article SSCI.59 Definitions and common provisions 1. For the purposes of this Section: (a) \"claim\" means all claims relating to contributions or to benefits paid or provided unduly, including interest, fines, administrative penalties and all other charges and costs connected with the claim in accordance with the legislation of the State making the claim; (b) \"applicant party\" means, in respect of each State, any institution which makes a request for information, notification or recovery concerning a claim as defined above; (c) \"requested party\" means, in respect of each State, any institution to which a request for information, notification or recovery can be made. 2. Requests and any related communications between the States shall, in general, be addressed via designated institutions. 3. Practical implementation measures, including, among others, those related to Article SSCI.4 and to setting a minimum threshold for the amounts for which a request for recovery can be made, shall be taken by the Specialised Committee on Social Security Coordination. Article SSCI.60 Requests for information 1. At the request of the applicant party, the requested party shall provide any information which would be useful to the applicant party in the recovery of its claim. 2. In order to obtain that information, the requested party shall make use of the powers provided for under the laws, regulations or administrative practices applying to the recovery of similar claims arising in its own State. The request for information shall indicate the name, last known address, and any other relevant information relating to the identification of the legal or natural person concerned to whom the information to be provided relates and the nature and amount of the claim in respect of which the request is made. 3. The requested party shall not be obliged to supply information: (a) which it would not be able to obtain for the purpose of recovering similar claims arising in its own territory; (b) which would disclose any commercial, industrial or professional secrets; or (c) the disclosure of which would be liable to prejudice the security of or be contrary to the public policy of a State. 4. The requested party shall inform the applicant party of the grounds for refusing a request for information. Article SSCI.61 Notification 1. The requested party shall, at the request of the applicant party, and in accordance with the rules in force for the notification of similar instruments or decisions in its own territory, notify the addressee of all instruments and decisions, including those of a judicial nature, which come from the State of the applicant party and which relate to a claim or to its recovery. 2. The request for notification shall indicate the name, address and any other relevant information relating to the identification of the addressee concerned to which the applicant party normally has access, the nature and the subject of the instrument or decision to be notified and, if necessary the name, address and any other relevant information relating to the identification of the debtor and the claim to which the instrument or decision relates, and any other useful information. 3. The requested party shall without delay inform the applicant party of the action taken on its request for notification and, particularly, of the date on which the decision or instrument was forwarded to the addressee. Article SSCI.62 Request for recovery 1. At the request of the applicant party, the requested party shall recover claims that are the subject of an instrument permitting enforcement issued by the applicant party to the extent permitted by and in accordance with the laws and administrative practices in force in the State of the requested party. 2. The applicant party may only make a request for recovery if: (a) it also provides to the requested party an official or certified copy of the instrument permitting enforcement of the claim in the State of the applicant party, except in cases where Article SSCI.64(3) is applied; (b) the claim or instrument permitting its enforcement are not contested in its own State; (c) it has, in its own State, applied appropriate recovery procedures available to it on the basis of the instrument referred to in paragraph 1, and the measures taken will not result in the payment in full of the claim; (d) the period of limitation according to its own legislation has not expired. 3. The request for recovery shall indicate: (a) the name, address and any other relevant information relating to the identification of the natural or legal person concerned or to the identification of any third party holding that person's assets; (b) the name, address and any other relevant information relating to the identification of the applicant party; (c) a reference to the instrument permitting its enforcement, issued in the State of the applicant party; (d) the nature and amount of the claim, including the principal, interest, fines, administrative penalties and all other charges and costs due indicated in the currencies of the State(s) of the applicant and requested parties; (e) the date of notification of the instrument to the addressee by the applicant party or by the requested party; (f) the date from which and the period during which enforcement is possible under the laws in force in the State of the applicant party; (g) any other relevant information. 4. The request for recovery shall also contain a declaration by the applicant party confirming that the conditions laid down in paragraph 2 have been fulfilled. 5. The applicant party shall forward to the requested party any relevant information relating to the matter which gave rise to the request for recovery, as soon as this comes to its knowledge. Article SSCI.63 Instrument permitting enforcement of recovery 1. In accordance with Article SSC.64(2) of this Protocol, the instrument permitting enforcement of the claim shall be directly recognised and treated automatically as an instrument permitting the enforcement of a claim of the State of the requested party 2. Notwithstanding paragraph 1, the instrument permitting enforcement of the claim may, where appropriate and in accordance with the provisions in force in the State of the requested party, be accepted as, recognised as, supplemented with, or replaced by an instrument authorising enforcement in the territory of that State. Within three months of the date of receipt of the request for recovery, the State(s) shall endeavour to complete the acceptance, recognition, supplementing or replacement, except in cases where the third subparagraph of this paragraph applies. States may not refuse to complete these actions where the instrument permitting enforcement is properly drawn up. The requested party shall inform the applicant party of the grounds for exceeding the three-month period. If any of these actions should give rise to a dispute in connection with the claim or the instrument permitting enforcement issued by the applicant party, Article SSCI.65 shall apply. Article SSCI.64 Payment arrangements and deadline 1. Claims shall be recovered in the currency of the State of the requested party. The entire amount of the claim that is recovered by the requested party shall be remitted by the requested party to the applicant party. 2. The requested party may, where the laws, regulations or administrative provisions in force in its own State so permit, and after consulting the applicant party, allow the debtor time to pay or authorise payment by instalment. Any interest charged by the requested party in respect of such extra time to pay shall also be remitted to the applicant party. 3. From the date on which the instrument permitting enforcement of the recovery of the claim has been directly recognised in accordance with Article SSCI.63(1) or accepted, recognised, supplemented or replaced in accordance with Article SSCI.63(2), interest shall be charged for late payment under the laws, regulations and administrative provisions in force in the State of the requested party and shall also be remitted to the applicant party. Article SSCI.65 Contestation concerning the claim or the instrument permitting enforcement of its recovery and contestation concerning enforcement measures 1. If, in the course of the recovery procedure, the claim or the instrument permitting its enforcement issued in the State of the applicant party are contested by an interested party, the action shall be brought by this party before the appropriate authorities of the State of the applicant party, in accordance with the laws in force in that State. The applicant party shall without delay notify the requested party of this action. The interested party may also inform the requested party of the action. 2. As soon as the requested party has received the notification or information referred to in paragraph 1 either from the applicant party or from the interested party, it shall suspend the enforcement procedure pending the decision of the appropriate authority in the matter, unless the applicant party requests otherwise in accordance with the second subparagraph of this paragraph. Should the requested party deem it necessary, and without prejudice to Article SSCI.68, it may take precautionary measures to guarantee recovery insofar as the laws or regulations in force in its own State allow such action for similar claims. Notwithstanding the first subparagraph, the applicant party may, in accordance with the laws, regulations and administrative practices in force in its own State, request the requested party to recover a contested claim, insofar as the relevant laws, regulations and administrative practices in force in the requested party's State allow such action. If the result of the contestation is subsequently favourable to the debtor, the applicant party shall be liable for the reimbursement of any sums recovered, together with any compensation due, in accordance with the legislation in force in the requested party's State. 3. Where the contestation concerns enforcement measures taken in the State of the requested party, the action shall be brought before the appropriate authority of that State in accordance with its laws and regulations. 4. Where the appropriate authority before which the action is brought in accordance with paragraph 1 is a judicial or administrative tribunal, the decision of that tribunal, insofar as it is favourable to the applicant party and permits recovery of the claim in the State of the applicant party, shall constitute the \"instrument permitting enforcement\" within the meaning of Articles SSCI.62 and SSCI.63 and the recovery of the claim shall proceed on the basis of that decision. Article SSCI.66 Limits applying to assistance 1. The requested party shall not be obliged: (a) to grant the assistance provided for in Articles SSCI.62 to SSCI.65, if recovery of the claim would, because of the situation of the debtor, create serious economic or social difficulties in the State of the requested party, insofar as the laws, regulations or administrative practices in force in the State of the requested party allow such action for similar national claims; (b) to grant the assistance provided for in Articles SSCI.60 to SSCI.65, if the initial request under Articles SSCI.60 to SSCI.62 applies to claims more than five years old, dating from the moment the instrument permitting the recovery was established in accordance with the laws, regulations or administrative practices in force in the State of the applicant party at the date of the request. However, if the claim or instrument is contested, the time limit begins from the moment that the State of the applicant party establishes that the claim or the enforcement order permitting recovery may no longer be contested. 2. The requested party shall inform the applicant party of the grounds for refusing a request for assistance. Article SSCI.67 Periods of limitation 1. Questions concerning periods of limitation shall be governed as follows: (a) by the laws in force in the State of the applicant party, insofar as they concern the claim or the instrument permitting its enforcement; and (b) by the laws in force in the State of the requested party, insofar as they concern enforcement measures in the requested State. Periods of limitation according to the laws in force in the State of the requested party shall start from the date of direct recognition or from the date of acceptance, recognition, supplementing or replacement in accordance with Article SSCI.63. 2. Steps taken in the recovery of claims by the requested party in pursuance of a request for assistance, which, if they had been carried out by the applicant party, would have had the effect of suspending or interrupting the period of limitation according to the laws in force in the State of the applicant party, shall be deemed to have been taken in the latter, insofar as that effect is concerned. Article SSCI.68 Precautionary measures Upon reasoned request by the applicant party, the requested party shall take precautionary measures to ensure recovery of a claim insofar as the laws and regulations in force in the State of the requested party so permit. For the purposes of implementing the first paragraph, the provisions and procedures laid down in Articles SSCI.62, SSCI.63, SSCI.65 and SSCI.66 apply mutatis mutandis. Article SSCI.69 Costs related to recovery 1. The requested party shall recover from the natural or legal person concerned and retain any costs linked to recovery which it incurs, in accordance with the laws and regulations of the State of the requested party that apply to similar claims. 2. Mutual assistance afforded under this Section shall, as a rule, be free of charge. However, where recovery poses a specific problem or concerns a very large amount in costs, the applicant and the requested parties may agree on reimbursement arrangements specific to the cases in question. The State of the applicant party shall remain liable to the State of the requested party for any costs and any losses incurred as a result of actions held to be unfounded, as far as either the substance of the claim or the validity of the instrument issued by the applicant party is concerned. TITLE V MISCELLANEOUS, TRANSITIONAL AND FINAL PROVISIONS Article SSCI.70 Medical examination and administrative checks 1. Without prejudice to other provisions, where a recipient or a claimant of benefits, or a member of that person's family, is staying or residing within the territory of a State other than that in which the debtor institution is located, the medical examination shall be carried out, at the request of that institution, by the institution of the beneficiary's place of stay or residence in accordance with the procedures laid down by the legislation applied by that institution. The debtor institution shall inform the institution of the place of stay or residence of any special requirements, if necessary, to be followed and points to be covered by the medical examination. 2. The institution of the place of stay or residence shall forward a report to the debtor institution that requested the medical examination. This institution shall be bound by the findings of the institution of the place of stay or residence. The debtor institution shall reserve the right to have the beneficiary examined by a doctor of its choice. However, the beneficiary may be asked to return to the State of the debtor institution only if the beneficiary is able to make the journey without prejudice to the beneficiary's health and the cost of travel and accommodation is paid for by the debtor institution. 3. Where a recipient or a claimant of benefits, or a member of that person's family, is staying or residing in the territory of a State other than that in which the debtor institution is located, the administrative check shall, at the request of the debtor institution, be performed by the institution of the beneficiary's place of stay or residence. Paragraph 2 shall also apply in this case. 4. As an exception to the principle of free-of-charge mutual administrative cooperation in Article SSC.59(3) of this Protocol, the effective amount of the expenses of the checks referred to in this Article shall be refunded to the institution which was requested to carry them out by the debtor institution which requested them. Article SSCI.71 Notifications 1. The States shall notify the Specialised Committee on Social Security Coordination of the details of the bodies and entities defined in Article SSC.1 of this Protocol and points (a) and (b) of Article SSCI.1(2) of this Annex, and of the institutions designated in accordance with this Annex. 2. The bodies specified in paragraph 1 shall be provided with an electronic identity in the form of an identification code and electronic address. 3. The Specialised Committee on Social Security Coordination shall establish the structure, content and detailed arrangements, including the common format and model, for notification of the details specified in paragraph 1. 4. For the purposes of implementing this Protocol, the United Kingdom may take part in the Electronic Exchange of Social Security Information and bear the related costs. 5. The States shall be responsible for keeping the information specified in paragraph 1 up to date. Article SSCI.72 Information The Specialised Committee on Social Security Coordination shall prepare the information needed to ensure that the parties concerned are aware of their rights and the administrative formalities required in order to assert them. This information shall, where possible, be disseminated electronically via publication online on sites accessible to the public. The Specialised Committee on Social Security Coordination shall ensure that the information is regularly updated and monitor the quality of services provided to customers. Article SSCI.73 Currency conversion For the purposes of this Protocol and this Annex, the exchange rate between two currencies shall be the reference rate published by the financial institution designated for this purpose by the Specialised Committee on Social Security Coordination. The date to be taken into account for determining the exchange rate shall be fixed by the Specialised Committee on Social Security Coordination. Article SSCI.74 Implementing provisions The Specialised Committee on Social Security Coordination may adopt further guidance on the implementation of this Protocol and of this Annex. Article SSCI.75 Interim provisions for forms and documents 1. For an interim period, the end date of which shall be agreed by the Specialised Committee on Social Security Coordination, all forms and documents issued by the competent institutions in the format used immediately before this Protocol comes into force shall be valid for the purposes of implementing this Protocol and, where appropriate, shall continue to be used for the exchange of information between competent institutions. All such forms and documents issued before and during that interim period shall be valid until their expiry or cancellation. 2. The forms and documents valid in accordance with paragraph 1 include: (a) European Health Insurance Cards issued on behalf of the United Kingdom, which shall be valid entitlement documents for the purposes of Article SSC.17 and Article SSC.25(1) of this Protocol and Article SSCI.22 of this Annex; and (b) portable documents which certify a person's social security situation as required to give effect to this Protocol. Appendix SSCI-1 ADMINISTRATIVE ARRANGEMENTS BETWEEN TWO OR MORE STATES (referred to in Article SSCI.8 of this Annex) BELGIUM \u2014 UNITED KINGDOM The Exchange of Letters of 4 May and 14 June 1976 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) The Exchange of Letters of 18 January and 14 March 1977 regarding Article 36(3) of Regulation (EEC) No 1408/71 (arrangement for reimbursement or waiving of reimbursement of the costs of benefits in kind provided under the terms of Chapter 1 of Title III of Regulation (EEC) No 1408/71) as amended by the Exchange of Letters of 4 May and 23 July 1982 (agreement for reimbursement of costs incurred under Article 22(1)(a) of Regulation (EEC) No 1408/71) DENMARK \u2014 UNITED KINGDOM The Exchange of Letters of 30 March and 19 April 1977 as modified by an Exchange of Letters of 8 November 1989 and of 10 January 1990 on agreement of waiving of reimbursement of the costs of benefits in kind and administrative checks and medical examinations ESTONIA \u2014 UNITED KINGDOM The Arrangement finalised on 29 March 2006 between the Competent Authorities of the Republic of Estonia and of the United Kingdom under Article 36(3) and 63(3) of Regulation (EEC) No 1408/71 establishing other methods of reimbursement of the costs of benefits in kind provided under Regulation (EC) No 883/2004 by both countries with effect from 1 May 2004 FINLAND \u2014 UNITED KINGDOM The Exchange of Letters 1 and 20 June 1995 concerning Article 36(3) and 63(3) of Regulation (EEC) No 1408/71 (reimbursement or waiving of reimbursement of the cost of benefits in kind) and Article 105(2) of Regulation (EEC) 574/72 (waiving of reimbursement of the cost of administrative checks and medical examinations) FRANCE \u2014 UNITED KINGDOM The Exchange of Letters of 25 March and 28 April 1997 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) The Agreement of 8 December 1998 on the specific methods of determining the amounts to be reimbursed for benefits in kind pursuant to Regulations (EEC) No 1408/71 and (EEC) No 574/72 HUNGARY \u2014 UNITED KINGDOM The Arrangement finalised on 1 November 2005 between the Competent Authorities of the Republic of Hungary and of the United Kingdom under Article 35(3) and 41(2) of Regulation (EEC) No 883/2004 establishing other methods of reimbursement of the costs of benefits in kind provided under that Regulation by both countries with effect from 1 May 2004 IRELAND \u2014 UNITED KINGDOM The Exchange of Letters of 9 July 1975 regarding Article 36(3) and 63(3) of Regulation (EEC) No 1408/71 (arrangement for reimbursement or waiving of reimbursement of the costs of benefits in kind provided under the terms of Chapter 1 or 4 of Title III of Regulation (EEC) No 1408/71) and Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) ITALY \u2014 UNITED KINGDOM The Arrangement signed on 15 December 2005 between the Competent Authorities of the Italian Republic and of the United Kingdom under Article 36(3) and 63(3) of Regulation (EEC) No 1408/71 establishing other methods of reimbursement of the costs of benefits in kind provided under Regulation (EC) No 883/2004 by both countries with effect from 1 January 2005 LUXEMBOURG \u2014 UNITED KINGDOM The Exchange of Letters of 18 December 1975 and 20 January 1976 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs entailed in administrative checks and medical examinations referred to in Article 105 of Regulation (EEC) No 574/72) MALTA \u2014 UNITED KINGDOM The Arrangement finalised on 17 January 2007 between the Competent Authorities of Malta and of the United Kingdom under Article 35(3) and 41(2) of Regulation (EEC) No 883/2004 establishing other methods of reimbursement of the costs of benefits in kind provided under that Regulation by both countries with effect from 1 May 2004 NETHERLANDS \u2014 UNITED KINGDOM The second sentence of Article 3 of the Administrative Arrangement of 12 June 1956 on the implementation of the Convention of 11 August 1954 PORTUGAL \u2014 UNITED KINGDOM The Arrangement of 8 June 2004 establishing other methods of reimbursement of the costs of benefits in kind provided by both countries with effect from 1 January 2003 SPAIN \u2014 UNITED KINGDOM The Agreement of 18 June 1999 on the reimbursement of costs for benefits in kind granted pursuant to the provisions of Regulations (EEC) No 1408/71 and (EEC) No 574/72 SWEDEN \u2014 UNITED KINGDOM The Arrangement of 15 April 1997 concerning Article 36(3) and Article 63(3) of Regulation (EEC) No 1408/71 (reimbursement or waiving of reimbursement of the cost of benefits in kind) and Article 105(2) of Regulation (EEC) No 574/72 (waiving of refunds of the costs of administrative checks and medical examinations) Appendix SSCI-2 ENTITLEMENT DOCUMENT (Article SSC.17 and Article SSC.25(1) of this Protocol and Article SSCI.22 of this Annex) 1. Entitlement documents issued for the purposes of Article SSC.17 and Article SSC.25(1) of this Protocol by the competent institutions of Member States shall comply with Decision No S2 of 12 June 2009 of the Administrative Commission concerning the technical specifications of the European Health Insurance Card. 2. Entitlement documents issued for the purposes of Article SSC.17 and Article SSC.25(1) by the competent institutions of the United Kingdom shall contain the following data: (a) surname and forename of the document holder; (b) personal identification number of the document holder; (c) date of birth of the document holder; (d) expiry date of the document; (e) the code \"UK\" in lieu of the ISO code of the United Kingdom; (f) identification number and acronym of the United Kingdom institution issuing the document; (g) logical number of the document; (h) in the case of a provisional document, the date of issue and date of delivery of the document, and the signature and stamp of the United Kingdom institution. 3. The technical specifications of entitlement documents issued by the United Kingdom shall be notified without delay to the Specialised Committee on Social Security Coordination in order to facilitate the acceptance of the respective documents by institutions of the Member States providing the benefits in kind. BENEFITS IN KIND REQUIRING PRIOR AGREEMENT (Article SSC.17 and Article SSC.25(1) of this Protocol) 1. The benefits in kind to be provided under Article SSC.17 and Article SSC.25(1) of this Protocol shall include benefits provided in conjunction with chronic or existing illnesses as well as in conjunction with pregnancy and childbirth. 2. Benefits in kind, including those in conjunction with chronic or existing illnesses or in conjunction with childbirth, are not covered by these provisions when the objective of the stay in another State is to receive these treatments. 3. Any vital medical treatment which is only accessible in a specialised medical unit or given by specialised staff or equipment must be subject to a prior agreement between the insured person and the unit providing the treatment in order to ensure that the treatment is available during the insured person's stay in a State other than the competent State or the one of residence. 4. A non-exhaustive list of the treatments which fulfil these criteria is the following: (a) kidney dialysis; (b) oxygen therapy; (c) special asthma treatment; (d) echocardiography in case of chronic autoimmune diseases; (e) chemotherapy. Appendix SSCI-3 STATES CLAIMING THE REIMBURSEMENT OF THE COST OF BENEFITS IN KIND ON THE BASIS OF FIXED AMOUNTS (referred to in Article SSCI.48(1) of this Annex) IRELAND SPAIN CYPRUS PORTUGAL SWEDEN UNITED KINGDOM ANNEX SSC-8 TRANSITIONAL PROVISIONS REGARDING THE APPLICATION OF ARTICLE SSC.11 MEMBER STATES", "summary": "EU-UK Trade and Cooperation agreement EU-UK Trade and Cooperation agreement SUMMARY OF: Trade and cooperation agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information Decision (EU) 2020/2252 on the signing, on behalf of the Union, of the EU-UK Trade and Cooperation Agreement and of the Agreement concerning security procedures for exchanging and protecting classified information Decision (Euratom) 2020/2253 approving the conclusion of the Agreement between the Government of the United Kingdom of Great Britain and Northern Ireland and the European Atomic Energy Community for Cooperation on the Safe and Peaceful Uses of Nuclear Energy and of the Trade and Cooperation Agreement Declarations referred to in the Council Decision on the conclusion, on behalf of the Union, of the Trade and Cooperation Agreement and of the Agreement concerning security procedures for exchanging and protecting classified information Decision (EU) 2021/689 on the conclusion, on behalf of the Union, of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information Notice concerning the entry into force of the EU-UK Trade and Cooperation Agreement and of the Agreement concerning security procedures for exchanging and protecting classified information WHAT IS THE AIM OF THE DECISIONS, THE AGREEMENTS AND THE DECLARATIONS? The decisions cover the signing and application of the free trade agreement between the United Kingdom and the EU and the EU Member States. The agreement is designed to go further than a traditional free trade agreement and provide a solid basis to preserve friendship and cooperation in the future. It reflects the fact that the UK is leaving the EU\u2019s system of common rules, supervision and enforcement mechanisms, and will no longer enjoy the benefits of the EU\u2019s single market. The declarations set out political decisions agreed between the 2 parties on a number of specific issues and policy areas. KEY POINTS The agreement is divided into 7 parts followed by 3 protocols and more than 600 pages of annexes. Part 1: Common and institutional rules This part lays out the aims of the agreement, rules for supplementary agreements between the parties and sets out the institutional structure, including the Partnership Council committees and working groups designed to ensure the proper functioning of the agreement. Part 2: Trade, transport, fisheries and other arrangements This part is subdivided into several headings: 1.Trade \u2014 this heading covers a number of areas including: trade in goods \u2014 including an agreement for zero tariffs or quotas on goods traded, mutual recognition of trusted traders programmes, and rules of origin; services and investments \u2014 includes an agreement for equal treatment for EU service suppliers and investors in the UK and vice versa; digital trade \u2014 includes the removal of unjustified barriers to digital trade, including prohibition of data localisation requirements, while respecting data protection rules; energy \u2014 includes guarantees on security of energy supply, offshore energy cooperation in the North Sea, enforceable commitments towards the Paris Agreement and non-regression on climate change and carbon pricing; a level playing field for open and fair competition and sustainable development. 2. Aviation \u2014 the agreement includes: unlimited point-to-point traffic between EU and UK airports; cooperation on aviation safety, security and air traffic management; rules on ground-handling and slots (non-discrimination and access), and passenger rights. 3. Road transport \u2014 the agreement includes: unlimited point-to-point access for hauliers carrying loads between the EU and the UK and full transit rights across each other\u2019s territories; rules on working conditions, road safety, fair competition, and a level playing field regarding the environment, social issues and competition. 4. Social security coordination and visas for short term visits \u2014 the agreement includes: coordination of some social security benefits (old-age and survivors\u2019 pensions, pre-retirement, healthcare, maternity and paternity, accidents at work) making it easier to work abroad and not lose rights; non-discrimination clause ensures equal treatment of EU citizens for short-term visas. 5. Fisheries \u2014 the agreement includes: new arrangements ensure sustainable management of shared fish stocks in EU and UK waters, respecting both parties\u2019 rights and obligations as independent coastal states; a transition period of five and a half years during which reciprocal access rights to fish in each other\u2019s waters remain unchanged, with a gradual transfer of EU quotas to the UK. Part 3: Law enforcement and judicial cooperation in criminal matters The agreement ensures that the parties will work together in a number of ways including: continued cooperation between UK, Europol and Eurojust; arrangements for close cooperation between national police and judicial authorities of the UK and EU Member States, including on surrender; mechanisms for swift exchanges of Passenger Name Record (PNR) data, of DNA, fingerprints and vehicle registration data (Pr\u00fcm), and of criminal record information; cooperation on money-laundering and terrorist financing. Part 4: Thematic cooperation The agreement ensures cooperation on certain other issues including: cross-border health security threats; sharing classified information and best practice in the field of cyber security, including the opportunity for the UK to take part in the EU Agency for Cyber Security (ENISA). Part 5: Participation in EU programmes, sound financial management and financial provisions The UK will take part in 5 EU programmes open to non-EU country participation (subject to its financial contribution): Horizon Europe (research and innovation); Euratom Research and Training programme; ITER (fusion test facility); Copernicus (Earth monitoring system); Access to EU satellite surveillance & tracking (SST) services. Part 6: Dispute settlement and horizontal rules If a solution to a disagreement cannot be found between the parties, an independent arbitration tribunal can be set up to settle the matter through a binding ruling. This dispute settlement mechanism covers most areas of the agreement, including the level playing field and fisheries. The mechanism is accompanied by enforcement and safeguard mechanisms including the possibility to suspend market access commitments, e.g. by reintroducing tariffs and/or quotas in the affected area. Both parties will also be able to cross-retaliate* if the other does not comply with a ruling of an independent arbitration tribunal. Any substantial breach of obligations deemed \u2018essential elements\u2019 (fighting climate change, respecting democratic values and fundamental rights, or non-proliferation) can trigger the suspension or termination of all or part of the entire agreement. Part 7: Final provisions The agreement does not apply to Gibraltar nor to British overseas territories. The agreement and any supplementary agreements will be reviewed every 5 years. Annexes and protocols There are numerous annexes to the agreement covering issues such as: rules of procedure of the Partnership Council and committees; rules of origin; motor vehicles, equipment and parts; medical products; rules for authorised economic operators; guidelines for the recognition of professional qualifications. The are 3 protocols attached to the agreement: Protocol on administrative cooperation and combating fraud in the field of value added tax and for mutual assistance for the recovery of claims related to tax and duties \u2014 this protocol sets out the rules and procedures for cooperation in this field. Protocol on mutual administrative assistance in customs matters \u2014 this protocol is designed to enable the two parties to assist each other in ensuring the correct application of customs legislation, in particular by preventing, investigating and combating operations in breach of that legislation. Protocol on social security coordination \u2014 this protocol sets out the rules for coordination on: sickness benefits;maternity and paternity benefits;invalidity benefits;old-age benefits. Declarations The declarations cover a wide range of issues including: financial service regulatory cooperation; countering harmful tax regimes; monetary policy and subsidy control; road hauliers; asylum and returns; various aspects of law enforcement and judicial cooperation on criminal matters; exchange and protection of classified information; UK participation in EU programmes and access to programme services; a draft protocol on the programmes and activities in which the UK will participate. FROM WHEN DO THE DECISIONS AND AGREEMENT APPLY? Decisions (EU) 2020/2252 and (Euratom) 2020/2253 have applied since 29 December 2020. Following the consent of the European Parliament on 27 April 2021 and the Council decision on 29 April 2021, the EU-UK Trade and Cooperation Agreement and the Agreement on security of information entered into force on 1 May 2021. BACKGROUND The Trade and Cooperation Agreement follows on from the Withdrawal Agreement agreed between the UK and the EU which entered into force on 1 February 2020. The Withdrawal Agreement covered issues such as: citizens\u2019 rights \u2014 both of EU citizens living in the UK and vice versa; separation issues \u2014 steps to ensure an orderly withdrawal of the UK; a transition period from 1 February to 31 December 2020 \u2014 to enable a Trade and Cooperation Agreement to be negotiated, and during which the UK was treated in most respects as a Member State; the financial settlement \u2014 ensuring that the UK honoured its financial obligations as a Member State. KEY TERMS Cross-retaliation: retaliation by means such as tariffs, in one sector of trade, such as agriculture, to counter unfair actions or violations of agreements affecting trade in another sector. MAIN DOCUMENTS Trade and cooperation agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part (OJ L 149, 30.4.2021, pp. 10-2539) Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information (OJ L 149, 30.4.2021, pp. 2540-2548) Council Decision (EU) 2020/2252 of 29 December 2020 on the signing, on behalf of the Union, and on provisional application of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information (OJ L 444, 31.12.2020, pp. 2-10) Council Decision (Euratom) 2020/2253 of 29 December 2020 approving the conclusion, by the European Commission, of the Agreement between the Government of the United Kingdom of Great Britain and Northern Ireland and the European Atomic Energy Community for Cooperation on the Safe and Peaceful Uses of Nuclear Energy and the conclusion, by the European Commission, on behalf of the European Atomic Energy Community, of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part (OJ L 444, 31.12.2020, pp. 11-13) Declarations referred to in the Council Decision on the conclusion, on behalf of the Union, of the Trade and Cooperation Agreement and of the Agreement concerning security procedures for exchanging and protecting classified information (OJ L 149, 30.4.2021, pp. 2549-2559) Council Decision (EU) 2021/689 of 29 April 2021 on the conclusion, on behalf of the Union, of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information (OJ L 149, 30.4.2021, pp. 2-9) Notice concerning the entry into force of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information (OJ L 149, 30.4.2021, p. 2560) RELATED DOCUMENT Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ C 384I, 12.11.2019, pp. 1-177) last update 27.05.2021"}
{"article": "16.6.2017 EN Official Journal of the European Union L 154/1 REGULATION (EU) 2017/1001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2017 on the European Union trade mark (codification) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 118 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Council Regulation (EC) No 207/2009 (2) has been substantially amended several times (3). In the interests of clarity and rationality, that Regulation should be codified. (2) Council Regulation (EC) No 40/94 (4), which was codified in 2009 as Regulation (EC) No 207/2009, created a system of trade mark protection specific to the Union which provided for the protection of trade marks at the level of the Union, in parallel to the protection of trade marks available at the level of the Member States in accordance with the national trade mark systems, harmonised by Council Directive 89/104/EEC (5), which was codified as Directive 2008/95/EC of the European Parliament and of the Council (6). (3) It is desirable to promote throughout the Union a harmonious development of economic activities and a continuous and balanced expansion by completing an internal market which functions properly and offers conditions which are similar to those obtaining in a national market. In order to establish a market of this kind and make it increasingly a single market, not only should barriers to free movement of goods and services be removed and arrangements be instituted which ensure that competition is not distorted, but, in addition, legal conditions should be laid down which enable undertakings to adapt their activities to the scale of the Union, whether in manufacturing and distributing goods or in providing services. For those purposes, trade marks enabling the products and services of undertakings to be distinguished by identical means throughout the entire Union, regardless of frontiers, should feature amongst the legal instruments which undertakings have at their disposal. (4) For the purpose of pursuing the Union's said objectives it would appear necessary to provide for Union arrangements for trade marks whereby undertakings can by means of one procedural system obtain EU trade marks to which uniform protection is given and which produce their effects throughout the entire area of the Union. The principle of the unitary character of the EU trade mark thus stated should apply unless otherwise provided for in this Regulation. (5) The barrier of territoriality of the rights conferred on proprietors of trade marks by the laws of the Member States cannot be removed by approximation of laws. In order to open up unrestricted economic activity in the whole of the internal market for the benefit of undertakings, it should be possible to register trade marks which are governed by a uniform Union law directly applicable in all Member States. (6) The experience acquired since the establishment of the Community trade mark system has shown that undertakings from within the Union and from third countries have accepted the system which has become a successful and viable complement and alternative to the protection of trade marks at the level of the Member States. (7) The Union law relating to trade marks nevertheless does not replace the laws of the Member States on trade marks. It would not in fact appear to be justified to require undertakings to apply for registration of their trade marks as EU trade marks. (8) National trade marks continue to be necessary for those undertakings which do not want protection of their trade marks at Union level, or which are unable to obtain Union-wide protection while national protection does not face any obstacles. It should be left to each person seeking trade mark protection to decide whether the protection is sought only as a national trade mark in one or more Member States, or only as an EU trade mark, or both. (9) The rights in an EU trade mark should not be obtained otherwise than by registration, and registration should be refused in particular if the trade mark is not distinctive, if it is unlawful or if it conflicts with earlier rights. (10) A sign should be permitted to be represented in any appropriate form using generally available technology, and thus not necessarily by graphic means, as long as the representation is clear, precise, self-contained, easily accessible, intelligible, durable and objective. (11) The protection afforded by an EU trade mark, the function of which is in particular to guarantee the trade mark as an indication of origin, should be absolute in the case of identity between the mark and the sign and the goods or services. The protection should apply also in cases of similarity between the mark and the sign and the goods or services. An interpretation should be given for the concept of similarity in relation to the likelihood of confusion. The likelihood of confusion, the appreciation of which depends on numerous elements and, in particular, on the recognition of the trade mark on the market, the association which can be made with the used or registered sign, the degree of similarity between the trade mark and the sign and between the goods or services identified, should constitute the specific condition for such protection. (12) In order to ensure legal certainty and full consistency with the principle of priority, under which a registered earlier trade mark takes precedence over later registered trade marks, it is necessary to provide that the enforcement of rights conferred by an EU trade mark should be without prejudice to the rights of proprietors acquired prior to the filing or priority date of the EU trade mark. This is in conformity with Article 16(1) of the Agreement on trade-related aspects of intellectual property rights of 15 April 1994. (13) Confusion as to the commercial source from which the goods or services emanate may occur when a company uses the same or a similar sign as a trade name in such a way that a link is established between the company bearing the name and the goods or services coming from that company. Infringement of an EU trade mark should therefore also comprise the use of the sign as a trade name or similar designation as long as the use is made for the purposes of distinguishing goods or services. (14) In order to ensure legal certainty and full consistency with specific Union legislation, it is appropriate to provide that the proprietor of an EU trade mark should be entitled to prohibit a third party from using a sign in comparative advertising where such comparative advertising is contrary to Directive 2006/114/EC of the European Parliament and of the Council (7). (15) In order to ensure trade mark protection and combat counterfeiting effectively, and in line with international obligations of the Union under the framework of the World Trade Organisation (WTO), in particular Article V of the General Agreement on Tariffs and Trade (GATT) on freedom of transit and, as regards generic medicines, the \u2018Declaration on the TRIPS Agreement and public health\u2019 adopted by the Doha WTO Ministerial Conference on 14 November 2001, the proprietor of an EU trade mark should be entitled to prevent third parties from bringing goods, in the course of trade, into the Union without being released for free circulation there, where such goods come from third countries and bear without authorisation a trade mark which is identical or essentially identical with the EU trade mark registered in respect of such goods. (16) To this effect, it should be permissible for EU trade mark proprietors to prevent the entry of infringing goods and their placement in all customs situations, including transit, transhipment, warehousing, free zones, temporary storage, inward processing or temporary admission, also when such goods are not intended to be placed on the market of the Union. In performing customs controls, the customs authorities should make use of the powers and procedures laid down in Regulation (EU) No 608/2013 of the European Parliament and the Council (8), also at the request of the right holders. In particular, the customs authorities should carry out the relevant controls on the basis of risk analysis criteria. (17) In order to reconcile the need to ensure the effective enforcement of trade mark rights with the necessity to avoid hampering the free flow of trade in legitimate goods, the entitlement of the proprietor of the EU trade mark should lapse where, during the subsequent proceedings initiated before the European Union trade mark court (\u2018EU trade mark court\u2019) competent to take a substantive decision on whether the EU trade mark has been infringed, the declarant or the holder of the goods is able to prove that the proprietor of the EU trade mark is not entitled to prohibit the placing of the goods on the market in the country of final destination. (18) Article 28 of Regulation (EU) No 608/2013 provides that a right holder is to be liable for damages towards the holder of the goods where, inter alia, the goods in question are subsequently found not to infringe an intellectual property right. (19) Appropriate measures should be taken with a view to ensuring the smooth transit of generic medicines. With respect to international non-proprietary names (INN) as globally recognised generic names for active substances in pharmaceutical preparations, it is vital to take due account of the existing limitations on the effect of EU trade mark rights. Consequently, the proprietor of an EU trade mark should not have the right to prevent a third party from bringing goods into the Union without being released for free circulation there, based upon similarities between the INN for the active ingredient in the medicines and the trade mark. (20) In order to enable proprietors of EU trade marks to combat counterfeiting effectively, they should be entitled to prohibit the affixing of an infringing mark to goods and preparatory acts carried out prior to the affixing. (21) The exclusive rights conferred by an EU trade mark should not entitle the proprietor to prohibit the use of signs or indications by third parties which are used fairly and thus in accordance with honest practices in industrial and commercial matters. In order to ensure equal conditions for trade names and EU trade marks in the event of conflicts, given that trade names are regularly granted unrestricted protection against later trade marks, such use should be only considered to include the use of the personal name of the third party. It should further permit the use of descriptive or non-distinctive signs or indications in general. Furthermore, the proprietor should not be entitled to prevent the fair and honest use of the EU trade mark for the purpose of identifying or referring to the goods or services as those of the proprietor. Use of a trade mark by third parties to draw the consumer's attention to the resale of genuine goods that were originally sold by or with the consent of the proprietor of the EU trade mark in the Union should be considered as being fair as long as it is at the same time in accordance with honest practices in industrial and commercial matters. Use of a trade mark by third parties for the purpose of artistic expression should be considered as being fair as long as it is at the same time in accordance with honest practices in industrial and commercial matters. Furthermore, this Regulation should be applied in a way that ensures full respect for fundamental rights and freedoms, and in particular the freedom of expression. (22) It follows from the principle of free movement of goods that it is essential that the proprietor of an EU trade mark not be entitled to prohibit its use by a third party in relation to goods which have been put into circulation in the European Economic Area, under the trade mark, by him or with his consent, save where there exist legitimate reasons for the proprietor to oppose further commercialisation of the goods. (23) In order to ensure legal certainty and safeguard legitimately acquired trade mark rights, it is appropriate and necessary to lay down, without prejudice to the principle that the later trade mark cannot be enforced against the earlier trade mark, that proprietors of EU trade marks should not be entitled to oppose the use of a later trade mark if the later trade mark was acquired at a time when the earlier trade mark could not be enforced against the later trade mark. (24) There is no justification for protecting EU trade marks or, as against them, any trade mark which has been registered before them, except where the trade marks are actually used. (25) For reasons of equity and legal certainty, the use of an EU trade mark in a form that differs in elements which do not alter the distinctive character of that mark in the form in which it is registered should be sufficient to preserve the rights conferred regardless of whether the trade mark in the form as used is also registered. (26) An EU trade mark is to be regarded as an object of property which exists separately from the undertakings whose goods or services are designated by it. Accordingly, it should be capable of being transferred, of being charged as security in favour of a third party and of being the subject matter of licences. (27) Administrative measures are necessary at Union level for implementing in relation to every trade mark the trade mark law laid down by this Regulation. It is therefore essential, while retaining the Union's existing institutional structure and balance of powers, to provide for a European Union Intellectual Property Office (\u2018the Office\u2019) which is independent in relation to technical matters and has legal, administrative and financial autonomy. To this end it is necessary and appropriate that the Office should be a body of the Union having legal personality and exercising the powers which are conferred on it by this Regulation, and that it should operate within the framework of Union law without detracting from the competences exercised by the Union institutions. (28) EU trade mark protection is granted in relation to specific goods or services whose nature and number determine the extent of protection afforded to the trade mark proprietor. It is therefore essential to lay down rules for the designation and classification of goods and services in this Regulation and to ensure legal certainty and sound administration by requiring that the goods and services for which trade mark protection is sought are identified by the applicant with sufficient clarity and precision to enable the competent authorities and economic operators, on the basis of the application alone, to determine the extent of the protection applied for. The use of general terms should be interpreted as only including all goods and services clearly covered by the literal meaning of the term. Proprietors of EU trade marks, which because of the practice of the Office prior to 22 June 2012 were registered in respect of the entire heading of a class of the system of classification established by the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks of 15 June 1957, should be given the possibility to adapt their lists of goods and services in order to ensure that the content of the Register meets the requisite standard of clarity and precision in accordance with the case law of the Court of Justice of the European Union. (29) In order to avoid unnecessary delays in registering an EU trade mark, it is appropriate to lay down a regime of optional EU and national trade mark searches that should be flexible in terms of user needs and preferences. The optional EU and national trade mark searches should be complemented by the making available of all-encompassing, fast and powerful search engines for the use of the public free of charge within the context of cooperation between the Office and the central industrial property offices of the Member States, including the Benelux Office for Intellectual Property. (30) It is necessary to ensure that parties who are affected by decisions made by the Office are protected by the law in a manner which is suited to the special character of trade mark law. To that end, provision should be made for an appeal to lie from decisions of the various decision-making instances of the Office. A Board of Appeal of the Office should decide on the appeal. Decisions of the Boards of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. (31) In order to ensure the protection of EU trade marks the Member States should designate, having regard to their own national system, as limited a number as possible of national courts of first and second instance having jurisdiction in matters of infringement and validity of EU trade marks. (32) It is essential that decisions regarding the validity and infringement of EU trade marks have effect and cover the entire area of the Union, as this is the only way of preventing inconsistent decisions on the part of the courts and the Office and of ensuring that the unitary character of EU trade marks is not undermined. The provisions of Regulation (EU) No 1215/2012 of the European Parliament and of the Council (9) should apply to all actions at law relating to EU trade marks, save where this Regulation derogates from those rules. (33) Contradictory judgments should be avoided in actions which involve the same acts and the same parties and which are brought on the basis of an EU trade mark and parallel national trade marks. For this purpose, when the actions are brought in the same Member State, the way in which this is to be achieved is a matter for national procedural rules, which are not prejudiced by this Regulation, whilst when the actions are brought in different Member States, provisions modelled on the rules on lis pendens and related actions of Regulation (EU) No 1215/2012 appear appropriate. (34) With the aim of promoting convergence of practices and of developing common tools, it is necessary to establish an appropriate framework for cooperation between the Office and the industrial property offices of the Member States, including the Benelux Office for Intellectual Property, defining key areas of cooperation and enabling the Office to coordinate relevant common projects of interest to the Union and the Member States and to finance, up to a maximum amount, those projects. Those cooperation activities should be beneficial for undertakings using trade mark systems in Europe. For users of the Union regime laid down in this Regulation, the projects, particularly the databases for search and consultation purposes, should provide additional, inclusive, efficient tools that are free of charge to comply with the specific requirements arising from the unitary character of the EU trade mark. (35) It is desirable to facilitate friendly, expeditious and efficient dispute resolution by entrusting the Office with the establishment of a mediation centre the services of which could be used by any person with the aim of achieving a friendly settlement of disputes relating to EU trade marks and Community designs by mutual agreement. (36) The setting up of the EU trade mark system has resulted in increased financial burdens for the central industrial property offices and other authorities of the Member States. The additional costs are related to the handling of a higher number of opposition and invalidity proceedings involving EU trade marks or brought by proprietors of such trade marks; to the awareness-raising activities linked to the EU trade mark system; as well as to activities intended to ensure the enforcement of EU trade mark rights. It is, therefore, appropriate to ensure that the Office offset part of the costs incurred by Member States for the role they play in ensuring the smooth functioning of the EU trade mark system. The payment of such offsetting should be subject to the submission, by Member States, of relevant statistical data. The offsetting of costs should not be of such an extent that it would cause a budgetary deficit for the Office. (37) In order to guarantee the full autonomy and independence of the Office, it is considered necessary to grant it an autonomous budget whose revenue comes principally from fees paid by the users of the system. However, the Union budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the Union are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors. (38) In the interest of sound financial management, the accumulation by the Office of significant budgetary surpluses should be avoided. This should be without prejudice to the Office maintaining a financial reserve covering one year of its operational expenditure to ensure the continuity of its operations and the performance of its tasks. That reserve should only be used to ensure the continuity of the tasks of the Office as specified in this Regulation. (39) Given the essential importance of the amounts of fees payable to the Office for the functioning of the EU trade mark system and its complementary relationship as regards national trade mark systems, it is necessary to set those fee amounts directly in this Regulation in the form of an annex. The amounts of the fees should be fixed at a level which ensures that: first, the revenue they produce is in principle sufficient for the budget of the Office to be balanced; second, there is coexistence and complementarity between the EU trade mark and the national trade mark systems, also taking into account the size of the market covered by the EU trade mark and the needs of small and medium-sized enterprises; and third, the rights of proprietors of an EU trade mark are enforced efficiently in the Member States. (40) In order to ensure an effective, efficient and expeditious examination and registration of EU trade mark applications by the Office using procedures which are transparent, thorough, fair and equitable, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of specifying the details on the procedures for filing and examining an opposition and on the procedures governing the amendment of the application. (41) In order to ensure that an EU trade mark can be revoked or declared invalid in an effective and efficient way by means of transparent, thorough, fair and equitable procedures, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the procedures for revocation and declaration of invalidity. (42) In order to allow for an effective, efficient and complete review of decisions of the Office by the Boards of Appeal by means of a transparent, thorough, fair and equitable procedure which takes into account the principles laid down in this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the formal content of the notice of appeal, the procedure for the filing and examination of an appeal, the formal content and form of the Board of Appeal's decisions, and the reimbursement of the appeal fees. (43) In order to ensure a smooth, effective and efficient operation of the EU trade mark system, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the requirements as to the details on oral proceedings and the detailed arrangements for taking of evidence, the detailed arrangements for notification, the means of communication and the forms to be used by the parties to proceedings, the rules governing the calculation and duration of time limits, the procedures for the revocation of a decision or for cancellation of an entry in the Register, the detailed arrangements for the resumption of proceedings, and the details on representation before the Office. (44) In order to ensure an effective and efficient organisation of the Boards of Appeal, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the details on the organisation of the Boards of Appeal. (45) In order to ensure the effective and efficient registration of international trade marks in a manner that is fully consistent with the rules of the Protocol relating to the Madrid Agreement concerning the international registration of marks, adopted at Madrid on 27 June 1989 (\u2018Madrid Protocol\u2019), the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the details on the procedures concerning the filing and examination of an opposition, including the necessary communications to be made to the World Intellectual Property Organisation (WIPO), and the details of the procedure concerning international registrations based on a basic application or basic registration relating to a collective mark, certification mark or guarantee mark. (46) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (10). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (47) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of specifying the details concerning applications, requests, certificates, claims, regulations, notifications and any other document under the relevant procedural requirements established by this Regulation, as well as in respect of maximum rates for costs essential to the proceedings and actually incurred, details concerning publications in the European Union Trade Marks Bulletin and the Official Journal of the Office, the detailed arrangements for exchange of information between the Office and national authorities, detailed arrangements concerning translations of supporting documents in written proceedings, exact types of decisions to be taken by a single member of the opposition or cancellation divisions, details of the notification obligation pursuant to the Madrid Protocol, and detailed requirements regarding the request for territorial extension subsequent to international registration. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11). (48) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 EU trade mark 1. A trade mark for goods or services which is registered in accordance with the conditions contained in this Regulation and in the manner herein provided is hereinafter referred to as a \u2018European Union trade mark (\u201cEU trade mark\u201d)\u2019. 2. An EU trade mark shall have a unitary character. It shall have equal effect throughout the Union: it shall not be registered, transferred or surrendered or be the subject of a decision revoking the rights of the proprietor or declaring it invalid, nor shall its use be prohibited, save in respect of the whole Union. This principle shall apply unless otherwise provided for in this Regulation. Article 2 Office 1. A European Union Intellectual Property Office (\u2018the Office\u2019) is established. 2. All references in Union law to the Office for Harmonization in the Internal Market (Trade Marks and Designs) shall be read as references to the Office. Article 3 Capacity to act For the purpose of implementing this Regulation, companies or firms and other legal bodies shall be regarded as legal persons if, under the terms of the law governing them, they have the capacity in their own name to have rights and obligations of all kinds, to make contracts or accomplish other legal acts, and to sue and be sued. CHAPTER II THE LAW RELATING TO TRADE MARKS SECTION 1 Definition of an EU trade mark and obtaining an EU trade mark Article 4 Signs of which an EU trade mark may consist An EU trade mark may consist of any signs, in particular words, including personal names, or designs, letters, numerals, colours, the shape of goods or of the packaging of goods, or sounds, provided that such signs are capable of: (a) distinguishing the goods or services of one undertaking from those of other undertakings; and (b) being represented on the Register of European Union trade marks (\u2018the Register\u2019), in a manner which enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor. Article 5 Persons who can be proprietors of EU trade marks Any natural or legal person, including authorities established under public law, may be the proprietor of an EU trade mark. Article 6 Means whereby an EU trade mark is obtained An EU trade mark shall be obtained by registration. Article 7 Absolute grounds for refusal 1. The following shall not be registered: (a) signs which do not conform to the requirements of Article 4; (b) trade marks which are devoid of any distinctive character; (c) trade marks which consist exclusively of signs or indications which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin or the time of production of the goods or of rendering of the service, or other characteristics of the goods or service; (d) trade marks which consist exclusively of signs or indications which have become customary in the current language or in the bona fide and established practices of the trade; (e) signs which consist exclusively of: (i) the shape, or another characteristic, which results from the nature of the goods themselves; (ii) the shape, or another characteristic, of goods which is necessary to obtain a technical result; (iii) the shape, or another characteristic, which gives substantial value to the goods; (f) trade marks which are contrary to public policy or to accepted principles of morality; (g) trade marks which are of such a nature as to deceive the public, for instance as to the nature, quality or geographical origin of the goods or service; (h) trade marks which have not been authorised by the competent authorities and are to be refused pursuant to Article 6ter of the Paris Convention for the Protection of Industrial Property (\u2018Paris Convention\u2019); (i) trade marks which include badges, emblems or escutcheons other than those covered by Article 6ter of the Paris Convention and which are of particular public interest, unless the consent of the competent authority to their registration has been given; (j) trade marks which are excluded from registration, pursuant to Union legislation or national law or to international agreements to which the Union or the Member State concerned is party, providing for protection of designations of origin and geographical indications; (k) trade marks which are excluded from registration pursuant to Union legislation or international agreements to which the Union is party, providing for protection of traditional terms for wine; (l) trade marks which are excluded from registration pursuant to Union legislation or international agreements to which the Union is party, providing for protection of traditional specialities guaranteed; (m) trade marks which consist of, or reproduce in their essential elements, an earlier plant variety denomination registered in accordance with Union legislation or national law, or international agreements to which the Union or the Member State concerned is a party, providing for protection of plant variety rights, and which are in respect of plant varieties of the same or closely related species. 2. Paragraph 1 shall apply notwithstanding that the grounds of non-registrability obtain in only part of the Union. 3. Paragraph 1(b), (c) and (d) shall not apply if the trade mark has become distinctive in relation to the goods or services for which registration is requested as a consequence of the use which has been made of it. Article 8 Relative grounds for refusal 1. Upon opposition by the proprietor of an earlier trade mark, the trade mark applied for shall not be registered: (a) if it is identical with the earlier trade mark and the goods or services for which registration is applied for are identical with the goods or services for which the earlier trade mark is protected; (b) if, because of its identity with, or similarity to, the earlier trade mark and the identity or similarity of the goods or services covered by the trade marks there exists a likelihood of confusion on the part of the public in the territory in which the earlier trade mark is protected; the likelihood of confusion includes the likelihood of association with the earlier trade mark. 2. For the purposes of paragraph 1, \u2018earlier trade mark\u2019 means: (a) trade marks of the following kinds with a date of application for registration which is earlier than the date of application for registration of the EU trade mark, taking account, where appropriate, of the priorities claimed in respect of those trade marks: (i) EU trade marks; (ii) trade marks registered in a Member State, or, in the case of Belgium, the Netherlands or Luxembourg, at the Benelux Office for Intellectual Property; (iii) trade marks registered under international arrangements which have effect in a Member State; (iv) trade marks registered under international arrangements which have effect in the Union; (b) applications for the trade marks referred to in point (a), subject to their registration; (c) trade marks which, on the date of application for registration of the EU trade mark, or, where appropriate, of the priority claimed in respect of the application for registration of the EU trade mark, are well known in a Member State, in the sense in which the words \u2018well known\u2019 are used in Article 6bis of the Paris Convention. 3. Upon opposition by the proprietor of the trade mark, a trade mark shall not be registered where an agent or representative of the proprietor of the trade mark applies for registration thereof in his own name without the proprietor's consent, unless the agent or representative justifies his action. 4. Upon opposition by the proprietor of a non-registered trade mark or of another sign used in the course of trade of more than mere local significance, the trade mark applied for shall not be registered where and to the extent that, pursuant to Union legislation or the law of the Member State governing that sign: (a) rights to that sign were acquired prior to the date of application for registration of the EU trade mark, or the date of the priority claimed for the application for registration of the EU trade mark; (b) that sign confers on its proprietor the right to prohibit the use of a subsequent trade mark. 5. Upon opposition by the proprietor of a registered earlier trade mark within the meaning of paragraph 2, the trade mark applied for shall not be registered where it is identical with, or similar to, an earlier trade mark, irrespective of whether the goods or services for which it is applied are identical with, similar to or not similar to those for which the earlier trade mark is registered, where, in the case of an earlier EU trade mark, the trade mark has a reputation in the Union or, in the case of an earlier national trade mark, the trade mark has a reputation in the Member State concerned, and where the use without due cause of the trade mark applied for would take unfair advantage of, or be detrimental to, the distinctive character or the repute of the earlier trade mark. 6. Upon opposition by any person authorised under the relevant law to exercise the rights arising from a designation of origin or a geographical indication, the trade mark applied for shall not be registered where and to the extent that, pursuant to the Union legislation or national law providing for the protection of designations of origin or geographical indications: (i) an application for a designation of origin or a geographical indication had already been submitted, in accordance with Union legislation or national law, prior to the date of application for registration of the EU trade mark or the date of the priority claimed for the application, subject to its subsequent registration; (ii) that designation of origin or geographical indication confers the right to prohibit the use of a subsequent trade mark. SECTION 2 Effects of an EU trade mark Article 9 Rights conferred by an EU trade mark 1. The registration of an EU trade mark shall confer on the proprietor exclusive rights therein. 2. Without prejudice to the rights of proprietors acquired before the filing date or the priority date of the EU trade mark, the proprietor of that EU trade mark shall be entitled to prevent all third parties not having his consent from using in the course of trade, in relation to goods or services, any sign where: (a) the sign is identical with the EU trade mark and is used in relation to goods or services which are identical with those for which the EU trade mark is registered; (b) the sign is identical with, or similar to, the EU trade mark and is used in relation to goods or services which are identical with, or similar to, the goods or services for which the EU trade mark is registered, if there exists a likelihood of confusion on the part of the public; the likelihood of confusion includes the likelihood of association between the sign and the trade mark; (c) the sign is identical with, or similar to, the EU trade mark irrespective of whether it is used in relation to goods or services which are identical with, similar to or not similar to those for which the EU trade mark is registered, where the latter has a reputation in the Union and where use of that sign without due cause takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the EU trade mark. 3. The following, in particular, may be prohibited under paragraph 2: (a) affixing the sign to the goods or to the packaging of those goods; (b) offering the goods, putting them on the market, or stocking them for those purposes under the sign, or offering or supplying services thereunder; (c) importing or exporting the goods under the sign; (d) using the sign as a trade or company name or part of a trade or company name; (e) using the sign on business papers and in advertising; (f) using the sign in comparative advertising in a manner that is contrary to Directive 2006/114/EC. 4. Without prejudice to the rights of proprietors acquired before the filing date or the priority date of the EU trade mark, the proprietor of that EU trade mark shall also be entitled to prevent all third parties from bringing goods, in the course of trade, into the Union without being released for free circulation there, where such goods, including packaging, come from third countries and bear without authorisation a trade mark which is identical with the EU trade mark registered in respect of such goods, or which cannot be distinguished in its essential aspects from that trade mark. The entitlement of the proprietor of an EU trade mark pursuant to the first subparagraph shall lapse if, during the proceedings to determine whether the EU trade mark has been infringed, initiated in accordance with Regulation (EU) No 608/2013, evidence is provided by the declarant or the holder of the goods that the proprietor of the EU trade mark is not entitled to prohibit the placing of the goods on the market in the country of final destination. Article 10 Right to prohibit preparatory acts in relation to the use of packaging or other means Where the risk exists that the packaging, labels, tags, security or authenticity features or devices or any other means to which the mark is affixed could be used in relation to goods or services and such use would constitute an infringement of the rights of the proprietor of an EU trade mark under Article 9(2) and (3), the proprietor of that trade mark shall have the right to prohibit the following acts if carried out in the course of trade: (a) affixing a sign identical with, or similar to, the EU trade mark on packaging, labels, tags, security or authenticity features or devices or any other means to which the mark may be affixed; (b) offering or placing on the market, or stocking for those purposes, or importing or exporting, packaging, labels, tags, security or authenticity features or devices or any other means to which the mark is affixed. Article 11 Date from which rights against third parties prevail 1. The rights conferred by an EU trade mark shall prevail against third parties from the date of publication of the registration of the trade mark. 2. Reasonable compensation may be claimed in respect of acts occurring after the date of publication of an EU trade mark application, where those acts would, after publication of the registration of the trade mark, be prohibited by virtue of that publication. 3. A court seised of a case shall not decide upon the merits of that case until the registration has been published. Article 12 Reproduction of an EU trade mark in a dictionary If the reproduction of an EU trade mark in a dictionary, encyclopaedia or similar reference work gives the impression that it constitutes the generic name of the goods or services for which the trade mark is registered, the publisher of the work shall, at the request of the proprietor of the EU trade mark, ensure that the reproduction of the trade mark at the latest in the next edition of the publication is accompanied by an indication that it is a registered trade mark. Article 13 Prohibition of the use of an EU trade mark registered in the name of an agent or representative Where an EU trade mark is registered in the name of the agent or representative of a person who is the proprietor of that trade mark, without the proprietor's authorisation, the latter shall be entitled to oppose the use of his mark by his agent or representative if he has not authorised such use, unless the agent or representative justifies his action. Article 14 Limitation of the effects of an EU trade mark 1. An EU trade mark shall not entitle the proprietor to prohibit a third party from using, in the course of trade: (a) the name or address of the third party, where that third party is a natural person; (b) signs or indications which are not distinctive or which concern the kind, quality, quantity, intended purpose, value, geographical origin, the time of production of goods or of rendering of the service, or other characteristics of the goods or services; (c) the EU trade mark for the purpose of identifying or referring to goods or services as those of the proprietor of that trade mark, in particular, where the use of that trade mark is necessary to indicate the intended purpose of a product or service, in particular as accessories or spare parts. 2. Paragraph 1 shall only apply where the use made by the third party is in accordance with honest practices in industrial or commercial matters. Article 15 Exhaustion of the rights conferred by an EU trade mark 1. An EU trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the European Economic Area under that trade mark by the proprietor or with his consent. 2. Paragraph 1 shall not apply where there exist legitimate reasons for the proprietor to oppose further commercialisation of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market. Article 16 Intervening right of the proprietor of a later registered trade mark as a defence in infringement proceedings 1. In infringement proceedings, the proprietor of an EU trade mark shall not be entitled to prohibit the use of a later registered EU trade mark where that later trade mark would not be declared invalid pursuant to Article 60(1), (3) or (4), Article 61(1) or (2), or Article 64(2) of this Regulation. 2. In infringement proceedings, the proprietor of an EU trade mark shall not be entitled to prohibit the use of a later registered national trade mark where that later registered national trade mark would not be declared invalid pursuant to Article 8 or Article 9(1) or (2), or Article 46(3) of Directive (EU) 2015/2436 of the European Parliament and of the Council (12). 3. Where the proprietor of an EU trade mark is not entitled to prohibit the use of a later registered trade mark pursuant to paragraph 1 or 2, the proprietor of that later registered trade mark shall not be entitled to prohibit the use of that earlier EU trade mark in infringement proceedings. Article 17 Complementary application of national law relating to infringement 1. The effects of EU trade marks shall be governed solely by the provisions of this Regulation. In other respects, infringement of an EU trade mark shall be governed by the national law relating to infringement of a national trade mark in accordance with the provisions of Chapter X. 2. This Regulation shall not prevent actions concerning an EU trade mark being brought under the law of Member States relating in particular to civil liability and unfair competition. 3. The rules of procedure to be applied shall be determined in accordance with the provisions of Chapter X. SECTION 3 Use of an EU trade mark Article 18 Use of an EU trade mark 1. If, within a period of five years following registration, the proprietor has not put the EU trade mark to genuine use in the Union in connection with the goods or services in respect of which it is registered, or if such use has been suspended during an uninterrupted period of five years, the EU trade mark shall be subject to the sanctions provided for in this Regulation, unless there are proper reasons for non-use. The following shall also constitute use within the meaning of the first subparagraph: (a) use of the EU trade mark in a form differing in elements which do not alter the distinctive character of the mark in the form in which it was registered, regardless of whether or not the trade mark in the form as used is also registered in the name of the proprietor; (b) affixing of the EU trade mark to goods or to the packaging thereof in the Union solely for export purposes. 2. Use of the EU trade mark with the consent of the proprietor shall be deemed to constitute use by the proprietor. SECTION 4 EU trade marks as objects of property Article 19 Dealing with EU trade marks as national trade marks 1. Unless Articles 20 to 28 provide otherwise, an EU trade mark as an object of property shall be dealt with in its entirety, and for the whole area of the Union, as a national trade mark registered in the Member State in which, according to the Register: (a) the proprietor has his seat or his domicile on the relevant date; (b) where point (a) does not apply, the proprietor has an establishment on the relevant date. 2. In cases which are not provided for by paragraph 1, the Member State referred to in that paragraph shall be the Member State in which the seat of the Office is situated. 3. If two or more persons are mentioned in the Register as joint proprietors, paragraph 1 shall apply to the joint proprietor first mentioned; failing this, it shall apply to the subsequent joint proprietors in the order in which they are mentioned. Where paragraph 1 does not apply to any of the joint proprietors, paragraph 2 shall apply. Article 20 Transfer 1. An EU trade mark may be transferred, separately from any transfer of the undertaking, in respect of some or all of the goods or services for which it is registered. 2. A transfer of the whole of the undertaking shall include the transfer of the EU trade mark except where, in accordance with the law governing the transfer, there is agreement to the contrary or circumstances clearly dictate otherwise. This provision shall apply to the contractual obligation to transfer the undertaking. 3. Without prejudice to paragraph 2, an assignment of the EU trade mark shall be made in writing and shall require the signature of the parties to the contract, except when it is a result of a judgment; otherwise it shall be void. 4. On request of one of the parties a transfer shall be entered in the Register and published. 5. An application for registration of a transfer shall contain information to identify the EU trade mark, the new proprietor, the goods and services to which the transfer relates, as well as documents duly establishing the transfer in accordance with paragraphs 2 and 3. The application may further contain, where applicable, information to identify the representative of the new proprietor. 6. The Commission shall adopt implementing acts specifying: (a) the details to be contained in the application for registration of a transfer; (b) the kind of documentation required to establish a transfer, taking account of the agreements given by the registered proprietor and the successor in title; (c) the details of how to process applications for partial transfers, ensuring that the goods and services in the remaining registration and the new registration do not overlap and that a separate file, including a new registration number, is established for the new registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 7. Where the conditions applicable to the registration of a transfer, as laid down in paragraphs 1, 2 and 3, or in the implementing acts referred to in paragraph 6, are not fulfilled, the Office shall notify the applicant of the deficiencies. If the deficiencies are not remedied within a period to be specified by the Office, it shall reject the application for registration of the transfer. 8. A single application for registration of a transfer may be submitted for two or more trade marks, provided that the registered proprietor and the successor in title are the same in each case. 9. Paragraphs 5 to 8 shall also apply to applications for EU trade marks. 10. In the case of a partial transfer, any application made by the original proprietor pending with regard to the original registration shall be deemed to be pending with regard to the remaining registration and the new registration. Where such application is subject to the payment of fees and those fees have been paid by the original proprietor, the new proprietor shall not be liable to pay any additional fees with regard to such application. 11. As long as the transfer has not been entered in the Register, the successor in title may not invoke the rights arising from the registration of the EU trade mark. 12. Where there are time limits to be observed vis-\u00e0-vis the Office, the successor in title may make the corresponding statements to the Office once the request for registration of the transfer has been received by the Office. 13. All documents which require notification to the proprietor of the EU trade mark in accordance with Article 98 shall be addressed to the person registered as proprietor. Article 21 Transfer of a trade mark registered in the name of an agent 1. Where an EU trade mark is registered in the name of the agent or representative of a person who is the proprietor of that trade mark, without the proprietor's authorisation, the latter shall be entitled to demand the assignment of the EU trade mark in his favour, unless such agent or representative justifies his action. 2. The proprietor may submit a request for assignment pursuant to paragraph 1 of this Article to the following: (a) the Office, pursuant to Article 60(1)(b), instead of an application for a declaration of invalidity; (b) a European Union trade mark court (\u2018EU trade mark court\u2019) as referred to in Article 123, instead of a counterclaim for a declaration of invalidity based on Article 128(1). Article 22 Rights in rem 1. An EU trade mark may, independently of the undertaking, be given as security or be the subject of rights in rem. 2. At the request of one of the parties, the rights referred to in paragraph 1 or the transfer of those rights shall be entered in the Register and published. 3. An entry in the Register effected pursuant to paragraph 2 shall be cancelled or modified at the request of one of the parties. Article 23 Levy of execution 1. An EU trade mark may be levied in execution. 2. As regards the procedure for levy of execution in respect of an EU trade mark, the courts and authorities of the Member States determined in accordance with Article 19 shall have exclusive jurisdiction. 3. On request of one the parties, the levy of execution shall be entered in the Register and published. 4. An entry in the Register effected pursuant to paragraph 3 shall be cancelled or modified at the request of one of the parties. Article 24 Insolvency proceedings 1. The only insolvency proceedings in which an EU trade mark may be involved are those opened in the Member State in the territory of which the debtor has his centre of main interests. However, where the debtor is an insurance undertaking or a credit institution as defined in Directive 2009/138/EC of the European Parliament and of the Council (13) and Directive 2001/24/EC of the European Parliament and of the Council (14), respectively, the only insolvency proceedings in which an EU trade mark may be involved are those opened in the Member State where that undertaking or institution has been authorised. 2. In the case of joint proprietorship of an EU trade mark, paragraph 1 shall apply to the share of the joint proprietor. 3. Where an EU trade mark is involved in insolvency proceedings, on request of the competent national authority an entry to this effect shall be made in the Register and published in the European Union Trade Marks Bulletin referred to in Article 116. Article 25 Licensing 1. An EU trade mark may be licensed for some or all of the goods or services for which it is registered and for the whole or part of the Union. A licence may be exclusive or non-exclusive. 2. The proprietor of an EU trade mark may invoke the rights conferred by that trade mark against a licensee who contravenes any provision in his licensing contract with regard to: (a) its duration; (b) the form covered by the registration in which the trade mark may be used; (c) the scope of the goods or services for which the licence is granted; (d) the territory in which the trade mark may be affixed; or (e) the quality of the goods manufactured or of the services provided by the licensee. 3. Without prejudice to the provisions of the licensing contract, the licensee may bring proceedings for infringement of an EU trade mark only if its proprietor consents thereto. However, the holder of an exclusive licence may bring such proceedings if the proprietor of the trade mark, after formal notice, does not himself bring infringement proceedings within an appropriate period. 4. A licensee shall, for the purpose of obtaining compensation for damage suffered by him, be entitled to intervene in infringement proceedings brought by the proprietor of the EU trade mark. 5. On request of one of the parties the grant or transfer of a licence in respect of an EU trade mark shall be entered in the Register and published. 6. An entry in the Register effected pursuant to paragraph 5 shall be cancelled or modified at the request of one of the parties. Article 26 Procedure for entering licences and other rights in the Register 1. Article 20(5) and (6) and the rules adopted pursuant to it and Article 20(8) shall apply mutatis mutandis to the registration of a right in rem or transfer of a right in rem as referred to in Article 22(2), the levy of execution as referred to in Article 23(3), the involvement in insolvency proceedings as referred to in Article 24(3), as well as to the registration of a licence or transfer of a licence as referred to in Article 25(5), subject to the following: (a) the requirement relating to the identification of goods and services to which the transfer relates shall not apply in respect of a request for registration of a right in rem, of a levy of execution or of insolvency proceedings; (b) the requirement relating to the documents proving the transfer shall not apply where the request is made by the proprietor of the EU trade mark. 2. The application for registration of the rights referred to in paragraph 1 shall not be deemed to have been filed until the required fee has been paid. 3. The application for registration of a licence may contain a request to record a licence in the Register as one or more of the following: (a) an exclusive licence; (b) a sub-licence in the event that the licence is granted by a licensee whose licence is recorded in the Register; (c) a licence limited to only part of the goods or services for which the mark is registered; (d) a licence limited to part of the Union; (e) a temporary licence. Where a request is made to record the licence as a licence listed in points (c), (d) and (e) of the first subparagraph, the application for registration of a licence shall indicate the goods and services, the part of the Union and the time period for which the licence is granted. 4. Where the conditions applicable to registration, as laid down in Articles 22 to 25, in paragraphs 1 and 3 of this Article and in the other applicable rules adopted pursuant to this Regulation, are not fulfilled, the Office shall notify the applicant of the deficiency. If the deficiency is not corrected within a period specified by the Office, it shall reject the application for registration. 5. Paragraphs 1 and 3 shall apply mutatis mutandis to applications for EU trade marks. Article 27 Effects vis-\u00e0-vis third parties 1. Legal acts referred to in Articles 20, 22 and 25 concerning an EU trade mark shall have effects vis-\u00e0-vis third parties in all the Member States only after entry in the Register. Nevertheless, such an act, before it is so entered, shall have effect vis-\u00e0-vis third parties who have acquired rights in the trade mark after the date of that act but who knew of the act at the date on which the rights were acquired. 2. Paragraph 1 shall not apply in the case of a person who acquires the EU trade mark or a right concerning the EU trade mark by way of transfer of the whole of the undertaking or by any other universal succession. 3. The effects vis-\u00e0-vis third parties of the legal acts referred to in Article 23 shall be governed by the law of the Member State determined in accordance with Article 19. 4. Until such time as common rules for the Member States in the field of bankruptcy enter into force, the effects vis-\u00e0-vis third parties of bankruptcy or similar proceedings shall be governed by the law of the Member State in which such proceedings are first brought within the meaning of national law or of conventions applicable in this field. Article 28 The application for an EU trade mark as an object of property Articles 19 to 27 shall apply to applications for EU trade marks. Article 29 Procedure for cancelling or modifying the entry in the Register of licences and other rights 1. A registration effected under Article 26(1) shall be cancelled or modified at the request of one of the persons concerned. 2. The application shall contain the registration number of the EU trade mark concerned and the particulars of the right for which registration is requested to be cancelled or modified. 3. The application for cancellation of a licence, a right in rem or an enforcement measure shall not be deemed to have been filed until the required fee has been paid. 4. The application shall be accompanied by documents showing that the registered right no longer exists or that the licensee or the holder of another right consents to the cancellation or modification of the registration. 5. Where the requirements for cancellation or modification of the registration are not satisfied, the Office shall notify the applicant of the deficiency. If the deficiency is not corrected within a period to be specified by the Office, it shall reject the application for cancellation or modification of the registration. 6. Paragraphs 1 to 5 of this Article shall apply mutatis mutandis to entries made in the files pursuant to Article 26(5). CHAPTER III APPLICATION FOR EU TRADE MARKS SECTION 1 Filing of applications and the conditions which govern them Article 30 Filing of applications 1. An application for an EU trade mark shall be filed at the Office. 2. The Office shall issue to the applicant, without delay, a receipt which shall include at least the file number, a representation, description or other identification of the mark, the nature and the number of the documents and the date of their receipt. That receipt may be issued by electronic means. Article 31 Conditions with which applications must comply 1. An application for an EU trade mark shall contain: (a) a request for the registration of an EU trade mark; (b) information identifying the applicant; (c) a list of the goods or services in respect of which the registration is requested; (d) a representation of the mark, which satisfies the requirements set out in Article 4(b). 2. The application for an EU trade mark shall be subject to the payment of the application fee covering one class of goods or services and, where appropriate, of one or more class fees for each class of goods and services exceeding the first class and, where applicable, the search fee. 3. In addition to the requirements referred to in paragraphs 1 and 2, an application for an EU trade mark shall comply with the formal requirements laid down in this Regulation and in the implementing acts adopted pursuant to it. If those conditions provide for the trade mark to be represented electronically, the Executive Director may determine the formats and maximum size of such an electronic file. 4. The Commission shall adopt implementing acts specifying the details to be contained in the application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 32 Date of filing The date of filing of an EU trade mark application shall be the date on which the documents containing the information specified in Article 31(1) are filed with the Office by the applicant, subject to payment of the application fee within one month of filing those documents. Article 33 Designation and classification of goods and services 1. Goods and services in respect of which trade mark registration is applied for shall be classified in conformity with the system of classification established by the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks of 15 June 1957 (\u2018the Nice Classification\u2019). 2. The goods and services for which the protection of the trade mark is sought shall be identified by the applicant with sufficient clarity and precision to enable the competent authorities and economic operators, on that sole basis, to determine the extent of the protection sought. 3. For the purposes of paragraph 2, the general indications included in the class headings of the Nice Classification or other general terms may be used, provided that they comply with the requisite standards of clarity and precision set out in this Article. 4. The Office shall reject an application in respect of indications or terms which are unclear or imprecise, where the applicant does not suggest an acceptable wording within a period set by the Office to that effect. 5. The use of general terms, including the general indications of the class headings of the Nice Classification, shall be interpreted as including all the goods or services clearly covered by the literal meaning of the indication or term. The use of such terms or indications shall not be interpreted as comprising a claim to goods or services which cannot be so understood. 6. Where the applicant requests registration for more than one class, the applicant shall group the goods and services according to the classes of the Nice Classification, each group being preceded by the number of the class to which that group of goods or services belongs, and shall present them in the order of the classes. 7. Goods and services shall not be regarded as being similar to each other on the ground that they appear in the same class under the Nice Classification. Goods and services shall not be regarded as being dissimilar from each other on the ground that they appear in different classes under the Nice Classification. 8. Proprietors of EU trade marks applied for before 22 June 2012 which are registered in respect of the entire heading of a Nice class may declare that their intention on the date of filing had been to seek protection in respect of goods or services beyond those covered by the literal meaning of the heading of that class, provided that the goods or services so designated are included in the alphabetical list for that class in the edition of the Nice Classification in force at the date of filing. The declaration shall be filed at the Office by 24 September 2016, and shall indicate, in a clear, precise and specific manner, the goods and services, other than those clearly covered by the literal meaning of the indications of the class heading, originally covered by the proprietor's intention. The Office shall take appropriate measures to amend the Register accordingly. The possibility to make a declaration in accordance with the first subparagraph of this paragraph shall be without prejudice to the application of Article 18, Article 47(2), Article 58(1)(a), and Article 64(2). EU trade marks for which no declaration is filed within the period referred to in the second subparagraph shall be deemed to extend, as from the expiry of that period, only to goods or services clearly covered by the literal meaning of the indications included in the heading of the relevant class. 9. Where the register is amended, the exclusive rights conferred by the EU trade mark under Article 9 shall not prevent a third party from continuing to use a trade mark in relation to goods or services where and to the extent that the use of the trade mark for those goods or services: (a) commenced before the register was amended; and (b) did not infringe the proprietor's rights based on the literal meaning of the record of the goods and services in the register at that time. In addition, the amendment of the list of goods or services recorded in the register shall not give the proprietor of the EU trade mark the right to oppose or to apply for a declaration of invalidity of a later trade mark where and to the extent that: (a) the later trade mark was either in use, or an application had been made to register the trade mark, for goods or services before the register was amended; and (b) the use of the trade mark in relation to those goods or services did not infringe, or would not have infringed, the proprietor's rights based on the literal meaning of the record of the goods and services in the register at that time. SECTION 2 Priority Article 34 Right of priority 1. A person who has duly filed an application for a trade mark in or in respect of any State party to the Paris Convention or to the Agreement establishing the World Trade Organisation, or his successors in title, shall enjoy, for the purpose of filing an EU trade mark application for the same trade mark in respect of goods or services which are identical with or contained within those for which the application has been filed, a right of priority during a period of six months from the date of filing of the first application. 2. Every filing that is equivalent to a regular national filing under the national law of the State where it was made or under bilateral or multilateral agreements shall be recognised as giving rise to a right of priority. 3. By a regular national filing is meant any filing that is sufficient to establish the date on which the application was filed, whatever may be the outcome of the application. 4. A subsequent application for a trade mark which was the subject of a previous first application in respect of the same goods or services and which is filed in or in respect of the same State shall be considered as the first application for the purposes of determining priority, provided that, at the date of filing of the subsequent application, the previous application has been withdrawn, abandoned or refused, without being open to public inspection and without leaving any rights outstanding, and has not served as a basis for claiming a right of priority. The previous application may not thereafter serve as a basis for claiming a right of priority. 5. If the first filing has been made in a State which is not a party to the Paris Convention or to the Agreement establishing the World Trade Organisation, paragraphs 1 to 4 shall apply only in so far as that State, according to published findings, grants, on the basis of the first filing made at the Office and subject to conditions equivalent to those laid down in this Regulation, a right of priority having equivalent effect. The Executive Director shall, where necessary, request the Commission to consider enquiring as to whether a State within the meaning of the first sentence accords that reciprocal treatment. If the Commission determines that reciprocal treatment in accordance with the first sentence is accorded, it shall publish a communication to that effect in the Official Journal of the European Union. 6. Paragraph 5 shall apply from the date of publication in the Official Journal of the European Union of the communication determining that reciprocal treatment is accorded, unless the communication states an earlier date from which it is applicable. It shall cease to apply from the date of publication in the Official Journal of the European Union of a communication of the Commission to the effect that reciprocal treatment is no longer accorded, unless the communication states an earlier date from which it is applicable. 7. Communications as referred to in paragraphs 5 and 6 shall also be published in the Official Journal of the Office. Article 35 Claiming priority 1. Priority claims shall be filed together with the EU trade mark application and shall include the date, number and country of the previous application. The documentation in support of priority claims shall be filed within three months of the filing date. 2. The Commission shall adopt implementing acts specifying the kind of documentation to be filed for claiming the priority of a previous application in accordance with paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 3. The Executive Director may determine that the documentation to be provided by the applicant in support of the priority claim may consist of less than what is required under the specifications adopted in accordance with paragraph 2, provided that the information required is available to the Office from other sources. Article 36 Effect of priority right The right of priority shall have the effect that the date of priority shall count as the date of filing of the EU trade mark application for the purposes of establishing which rights take precedence. Article 37 Equivalence of Union filing with national filing An EU trade mark application which has been accorded a date of filing shall, in the Member States, be equivalent to a regular national filing, where appropriate with the priority claimed for the EU trade mark application. SECTION 3 Exhibition priority Article 38 Exhibition priority 1. If an applicant for an EU trade mark has displayed goods or services under the mark applied for, at an official or officially recognised international exhibition falling within the terms of the Convention relating to international exhibitions signed at Paris on 22 November 1928 and last revised on 30 November 1972, he may, if he files the application within a period of six months of the date of the first display of the goods or services under the mark applied for, claim a right of priority from that date within the meaning of Article 36. The priority claim shall be filed together with the EU trade mark application. 2. An applicant who wishes to claim priority pursuant to paragraph 1 shall file evidence of the display of goods or services under the mark applied for within three months of the filing date. 3. An exhibition priority granted in a Member State or in a third country shall not extend the period of priority laid down in Article 34. 4. The Commission shall adopt implementing acts specifying the type and details of evidence to be filed for claiming an exhibition priority in accordance with paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). SECTION 4 Seniority of a national trade mark Article 39 Claiming seniority of a national trade mark in an application for an EU trade mark or subsequent to the filing of the application 1. The proprietor of an earlier trade mark registered in a Member State, including a trade mark registered in the Benelux countries, or registered under international arrangements having effect in a Member State, who applies for an identical trade mark for registration as an EU trade mark for goods or services which are identical with or contained within those for which the earlier trade mark has been registered, may claim for the EU trade mark the seniority of the earlier trade mark in respect of the Member State in or for which it is registered. 2. Seniority claims shall either be filed together with the EU trade mark application or within two months of the filing date of the application, and shall include the Member State or Member States in or for which the mark is registered, the number and the filing date of the relevant registration, and the goods and services for which the mark is registered. Where the seniority of one or more registered earlier trade marks is claimed in the application, the documentation in support of the seniority claim shall be filed within three months of the filing date. Where the applicant wishes to claim the seniority subsequent to the filing of the application, the documentation in support of the seniority claim shall be submitted to the Office within three months of receipt of the seniority claim. 3. Seniority shall have the sole effect under this Regulation that, where the proprietor of the EU trade mark surrenders the earlier trade mark or allows it to lapse, he shall be deemed to continue to have the same rights as he would have had if the earlier trade mark had continued to be registered. 4. The seniority claimed for the EU trade mark shall lapse where the earlier trade mark the seniority of which is claimed is declared to be invalid or revoked. Where the earlier trade mark is revoked, the seniority shall lapse provided that the revocation takes effect prior to the filing date or priority date of that EU trade mark. 5. The Office shall inform the Benelux Office for Intellectual Property or the central industrial property office of the Member State concerned of the effective claiming of seniority. 6. The Commission shall adopt implementing acts specifying the kind of documentation to be filed for claiming the seniority of a national trade mark or a trade mark registered under international agreements having effect in a Member State in accordance with paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 7. The Executive Director may determine that the documentation to be provided by the applicant in support of the seniority claim may consist of less than what is required under the specifications adopted in accordance with paragraph 6, provided that the information required is available to the Office from other sources. Article 40 Claiming seniority of a national trade mark after registration of an EU trade mark 1. The proprietor of an EU trade mark who is the proprietor of an earlier identical trade mark registered in a Member State, including a trade mark registered in the Benelux countries or of an earlier identical trade mark, with an international registration effective in a Member State, for goods or services which are identical to those for which the earlier trade mark has been registered, or contained within them, may claim the seniority of the earlier trade mark in respect of the Member State in or for which it was registered. 2. Seniority claims filed pursuant to paragraph 1 of this Article shall include the registration number of the EU trade mark, the name and address of its proprietor, the Member State or Member States in or for which the earlier mark is registered, the number and the filing date of the relevant registration, the goods and services for which the mark is registered and those in respect of which seniority is claimed, and supporting documentation as provided for in the rules adopted pursuant to Article 39(6). 3. If the requirements governing the claiming of seniority are not fulfilled, the Office shall communicate the deficiency to the proprietor of the EU trade mark. If the deficiency is not remedied within a period to be specified by the Office, the Office shall reject the claim. 4. Article 39(3), (4), (5) and (7) shall apply. CHAPTER IV REGISTRATION PROCEDURE SECTION 1 Examination of applications Article 41 Examination of the conditions of filing 1. The Office shall examine whether: (a) the EU trade mark application satisfies the requirements for the accordance of a date of filing in accordance with Article 32; (b) the EU trade mark application complies with the conditions and requirements referred to in Article 31(3); (c) where appropriate, the class fees have been paid within the prescribed period. 2. Where the EU trade mark application does not satisfy the requirements referred to in paragraph 1, the Office shall request the applicant to remedy the deficiencies or the default on payment within two months of the receipt of the notification. 3. If the deficiencies or the default on payment established pursuant to paragraph 1(a) are not remedied within this period, the application shall not be dealt with as an EU trade mark application. If the applicant complies with the Office's request, the Office shall accord as the date of filing of the application the date on which the deficiencies or the default on payment established are remedied. 4. If the deficiencies established pursuant to paragraph 1(b) are not remedied within the prescribed period, the Office shall refuse the application. 5. If the default on payment established pursuant to paragraph 1(c) is not remedied within the prescribed period, the application shall be deemed to be withdrawn unless it is clear which categories of goods or services the amount paid is intended to cover. In the absence of other criteria to determine which classes are intended to be covered, the Office shall take the classes in the order of the classification. The application shall be deemed to have been withdrawn with regard to those classes for which the class fees have not been paid or have not been paid in full. 6. Failure to satisfy the requirements concerning the claim to priority shall result in loss of the right of priority for the application. 7. Failure to satisfy the requirements concerning the claiming of seniority of a national trade mark shall result in loss of that right for the application. 8. Where failure to satisfy the requirements referred to in paragraph 1(b) and (c) concerns only some of the goods or services, the Office shall refuse the application, or the right of priority or the right of seniority shall be lost, only in so far as those goods and services are concerned. Article 42 Examination as to absolute grounds for refusal 1. Where, under Article 7, a trade mark is ineligible for registration in respect of some or all of the goods or services covered by the EU trade mark application, the application shall be refused as regards those goods or services. 2. The application shall not be refused before the applicant has been allowed the opportunity to withdraw or amend the application or to submit his observations. To this effect, the Office shall notify the applicant of the grounds for refusing registration and shall specify a period within which he may withdraw or amend the application or submit his observations. Where the applicant fails to overcome the grounds for refusing registration, the Office shall refuse registration in whole or in part. SECTION 2 Search Article 43 Search report 1. The Office shall, at the request of the applicant for the EU trade mark when filing the application, draw up a European Union search report (\u2018EU search report\u2019) citing those earlier EU trade marks or EU trade mark applications discovered which may be invoked under Article 8 against the registration of the EU trade mark applied for. 2. Where, at the time of filing an EU trade mark application, the applicant requests that a search report be prepared by the central industrial property offices of the Member States and where the appropriate search fee has been paid within the time limit for the payment of the filing fee, the Office shall transmit without delay a copy of the EU trade mark application to the central industrial property office of each Member State which has informed the Office of its decision to operate a search in its own register of trade marks in respect of EU trade mark applications. 3. Each of the central industrial property offices of the Member States referred to in paragraph 2 shall communicate a search report which shall either cite any earlier national trade marks, national trade mark applications or trade marks registered under international agreements, having effect in the Member State or Member States concerned, which have been discovered and which may be invoked under Article 8 against the registration of the EU trade mark applied for, or state that the search has revealed no such rights. 4. The Office, after consulting the Management Board provided for in Article 153 (\u2018the Management Board\u2019), shall establish the contents and modalities for the reports. 5. The Office shall pay an amount to each central industrial property office for each search report provided in accordance with paragraph 3. The amount, which shall be the same for each office, shall be fixed by the Budget Committee by means of a decision adopted by a majority of three quarters of the representatives of the Member States. 6. The Office shall transmit to the applicant for the EU trade mark the EU search report requested and any requested national search reports received. 7. Upon publication of the EU trade mark application, the Office shall inform the proprietors of any earlier EU trade marks or EU trade mark applications cited in the EU search report of the publication of the EU trade mark application. The latter shall apply irrespective of whether the applicant has requested to receive the EU search report, unless the proprietor of an earlier registration or application requests not to receive the notification. SECTION 3 Publication of the application Article 44 Publication of the application 1. If the conditions which the application for an EU trade mark is required to satisfy have been fulfilled, the application shall be published for the purposes of Article 46 to the extent that it has not been refused pursuant to Article 42. The publication of the application shall be without prejudice to information already made available to the public otherwise in accordance with this Regulation or acts adopted pursuant to this Regulation. 2. Where, after publication, the application is refused pursuant to Article 42, the decision that it has been refused shall be published upon becoming final. 3. Where the publication of the application contains an error attributable to the Office, the Office shall of its own motion or at the request of the applicant correct the error and publish the correction. The rules adopted pursuant to Article 49(3) shall apply mutatis mutandis where a correction is requested by the applicant. 4. Article 46(2) shall also apply where the correction concerns the list of goods or services or the representation of the mark. 5. The Commission shall adopt implementing acts laying down the details to be contained in the publication of the application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). SECTION 4 Observations by third parties and opposition Article 45 Observations by third parties 1. Any natural or legal person and any group or body representing manufacturers, producers, suppliers of services, traders or consumers may submit to the Office written observations, explaining on which grounds, under Articles 5 and 7, the trade mark should not be registered ex officio. Persons and groups or bodies as referred to in the first subparagraph shall not be parties to the proceedings before the Office. 2. Third party observations shall be submitted before the end of the opposition period or, where an opposition against the trade mark has been filed, before the final decision on the opposition is taken. 3. The submission referred to in paragraph 1 shall be without prejudice to the right of the Office to re-open the examination of absolute grounds on its own initiative at any time before registration, where appropriate. 4. The observations referred to in paragraph 1 shall be communicated to the applicant who may comment on them. Article 46 Opposition 1. Within a period of three months following the publication of an EU trade mark application, notice of opposition to registration of the trade mark may be given on the grounds that it may not be registered under Article 8: (a) by the proprietors of earlier trade marks referred to in Article 8(2) as well as licensees authorised by the proprietors of those trade marks, in respect of Article 8(1) and (5); (b) by the proprietors of trade marks referred to in Article 8(3); (c) by the proprietors of earlier marks or signs referred to in Article 8(4) and by persons authorised under the relevant national law to exercise these rights; (d) by the persons authorised under the relevant Union legislation or national law to exercise the rights referred to in Article 8(6). 2. Notice of opposition to registration of the trade mark may also be given, subject to the conditions laid down in paragraph 1, in the event of the publication of an amended application in accordance with the second sentence of Article 49(2). 3. Opposition shall be expressed in writing, and shall specify the grounds on which it is made. It shall not be considered as duly entered until the opposition fee has been paid. 4. Within a period to be fixed by the Office, the opponent may submit facts, evidence and arguments in support of his case. Article 47 Examination of opposition 1. In the examination of the opposition the Office shall invite the parties, as often as necessary, to file observations, within a period set by the Office, on communications from the other parties or issued by itself. 2. If the applicant so requests, the proprietor of an earlier EU trade mark who has given notice of opposition shall furnish proof that, during the five-year period preceding the date of filing or the date of priority of the EU trade mark application, the earlier EU trade mark has been put to genuine use in the Union in connection with the goods or services in respect of which it is registered and which he cites as justification for his opposition, or that there are proper reasons for non-use, provided that the earlier EU trade mark has at that date been registered for not less than five years. In the absence of proof to this effect, the opposition shall be rejected. If the earlier EU trade mark has been used in relation to only part of the goods or services for which it is registered it shall, for the purposes of the examination of the opposition, be deemed to be registered in respect only of that part of the goods or services. 3. Paragraph 2 shall apply to earlier national trade marks referred to in Article 8(2)(a), by substituting use in the Member State in which the earlier national trade mark is protected for use in the Union. 4. The Office may, if it thinks fit, invite the parties to make a friendly settlement. 5. If examination of the opposition reveals that the trade mark may not be registered in respect of some or all of the goods or services for which the EU trade mark application has been made, the application shall be refused in respect of those goods or services. Otherwise the opposition shall be rejected. 6. The decision refusing the application shall be published upon becoming final. Article 48 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details of the procedure for filing and examining an opposition set out in Articles 46 and 47. SECTION 5 Withdrawal, restriction, amendment and division of the application Article 49 Withdrawal, restriction and amendment of the application 1. The applicant may at any time withdraw his EU trade mark application or restrict the list of goods or services contained therein. Where the application has already been published, the withdrawal or restriction shall also be published. 2. In other respects, an EU trade mark application may be amended, upon request of the applicant, only by correcting the name and address of the applicant, errors of wording or of copying, or obvious mistakes, provided that such correction does not substantially change the trade mark or extend the list of goods or services. Where the amendments affect the representation of the trade mark or the list of goods or services and are made after publication of the application, the trade mark application shall be published as amended. 3. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details of the procedure governing the amendment of the application. Article 50 Division of the application 1. The applicant may divide the application by declaring that some of the goods or services included in the original application will be the subject of one or more divisional applications. The goods or services in the divisional application shall not overlap with the goods or services which remain in the original application or those which are included in other divisional applications. 2. The declaration of division shall not be admissible: (a) if, where an opposition has been entered against the original application, such a divisional application has the effect of introducing a division amongst the goods or services against which the opposition has been directed, until the decision of the Opposition Division has become final or the opposition proceedings are finally terminated otherwise; (b) before the date of filing referred to in Article 32 has been accorded by the Office and during the opposition period provided for in Article 46(1). 3. The declaration of division shall be subject to a fee. The declaration shall be deemed not to have been made until the fee has been paid. 4. Where the Office finds that the requirements laid down in paragraph 1 and in the rules adopted pursuant to paragraph 9(a) are not fulfilled, it shall invite the applicant to remedy the deficiencies within a period to be specified by the Office. If the deficiencies are not remedied before the time limit expires, the Office shall refuse the declaration of division. 5. The division shall take effect on the date on which it is recorded in the files kept by the Office concerning the original application. 6. All requests and applications submitted and all fees paid with regard to the original application prior to the date on which the Office receives the declaration of division are deemed also to have been submitted or paid with regard to the divisional application or applications. The fees for the original application which have been duly paid prior to the date on which the declaration of division is received shall not be refunded. 7. The divisional application shall preserve the filing date and any priority date and seniority date of the original application. 8. Where the declaration of division relates to an application which has already been published pursuant to Article 44, the division shall be published. The divisional application shall be published. The publication shall not open a new period for the filing of oppositions. 9. The Commission shall adopt implementing acts specifying: (a) the details to be contained in a declaration of the division of an application made pursuant to paragraph 1; (b) the details as to how to process a declaration of the division of an application, ensuring that a separate file, including a new application number, is established for the divisional application; (c) the details to be contained in the publication of the divisional application pursuant to paragraph 8. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). SECTION 6 Registration Article 51 Registration 1. Where an application meets the requirements set out in this Regulation and where no notice of opposition has been given within the period referred to in Article 46(1) or where any opposition entered has been finally disposed of by withdrawal, rejection or other disposition, the trade mark and the particulars referred to in Article 111(2) shall be recorded in the Register. The registration shall be published. 2. The Office shall issue a certificate of registration. That certificate may be issued by electronic means. The Office shall provide certified or uncertified copies of the certificate subject to the payment of a fee, where those copies are issued other than by electronic means. 3. The Commission shall adopt implementing acts specifying the details to be contained in and the form of the certificate of registration referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). CHAPTER V DURATION, RENEWAL, ALTERATION AND DIVISION OF EU TRADE MARKS Article 52 Duration of registration EU trade marks shall be registered for a period of 10 years from the date of filing of the application. Registration may be renewed in accordance with Article 53 for further periods of 10 years. Article 53 Renewal 1. Registration of the EU trade mark shall be renewed at the request of the proprietor of the EU trade mark or any person expressly authorised by him, provided that the fees have been paid. 2. The Office shall inform the proprietor of the EU trade mark, and any person having a registered right in respect of the EU trade mark, of the expiry of the registration at least six months before the said expiry. Failure to give such information shall not involve the responsibility of the Office and shall not affect the expiry of the registration. 3. The request for renewal shall be submitted in the six-month period prior to the expiry of the registration. The basic fee for the renewal and, where appropriate, one or more class fees for each class of goods or services exceeding the first one shall also be paid within this period. Failing this, the request may be submitted and the fees paid within a further period of six months following the expiry of registration, provided that an additional fee for late payment of the renewal fee or late submission of the request for renewal is paid within this further period. 4. The request for renewal shall include: (a) the name of the person requesting renewal; (b) the registration number of the EU trade mark to be renewed; (c) if the renewal is requested for only part of the registered goods and services, an indication of those classes or those goods and services for which renewal is requested, or those classes or those goods and services for which renewal is not requested, grouped according to the classes of the Nice classification, each group being preceded by the number of the class of that classification to which that group of goods or services belongs, and presented in the order of classes of that classification. If the payment referred to in paragraph 3 is made, it shall be deemed to constitute a request for renewal provided that it contains all necessary indications to establish the purpose of the payment. 5. Where the request is submitted or the fees paid in respect of only some of the goods or services for which the EU trade mark is registered, registration shall be renewed for those goods or services only. Where the fees paid are insufficient to cover all the classes of goods and services for which renewal is requested, registration shall be renewed if it is clear which class or classes are to be covered. In the absence of other criteria, the Office shall take the classes into account in the order of classification. 6. Renewal shall take effect from the day following the date on which the existing registration expires. The renewal shall be registered. 7. Where the request for renewal is filed within the periods provided for in paragraph 3, but the other conditions governing renewal provided for in this Article are not satisfied, the Office shall inform the applicant of the deficiencies found. 8. Where a request for renewal is not submitted or is submitted after the expiry of the period provided for in paragraph 3, or where the fees are not paid or are paid only after the period in question has expired, or where the deficiencies referred to in paragraph 7 are not remedied within that period, the Office shall determine that the registration has expired and shall notify the proprietor of the EU trade mark accordingly. Where the determination has become final, the Office shall cancel the mark from the register. The cancellation shall take effect from the day following the date on which the existing registration expired. Where the renewal fees have been paid but the registration is not renewed, those fees shall be refunded. 9. A single request for renewal may be submitted for two or more marks, upon payment of the required fees for each of the marks, provided that the proprietors or the representatives are the same in each case. Article 54 Alteration 1. The EU trade mark shall not be altered in the Register during the period of registration or on renewal thereof. 2. Nevertheless, where the EU trade mark includes the name and address of the proprietor, any alteration thereof not substantially affecting the identity of the trade mark as originally registered may be registered at the request of the proprietor. 3. The request for alteration shall include the element of the mark to be altered and that element in its altered version. The Commission shall adopt implementing acts specifying the details to be contained in the request for alteration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 4. The request shall be deemed not to have been filed until the required fee has been paid. If the fee has not been paid or has not been paid in full, the Office shall inform the applicant accordingly. A single request may be made for the alteration of the same element in two or more registrations of the same proprietor. The required fee shall be paid in respect of each registration to be altered. If the requirements governing the alteration of the registration are not fulfilled, the Office shall communicate the deficiency to the applicant. If the deficiency is not remedied within a period to be specified by the Office, the Office shall reject the request. 5. The publication of the registration of the alteration shall contain a representation of the EU trade mark as altered. Third parties whose rights may be affected by the alteration may challenge the registration thereof within the period of three months following publication. Articles 46 and 47 and rules adopted pursuant to Article 48 shall apply to the publication of the registration of the alteration. Article 55 Change of the name or address 1. A change of the name or address of the proprietor of the EU trade mark which is not an alteration of the EU trade mark pursuant to Article 54(2) and which is not the consequence of a whole or partial transfer of the EU trade mark shall, at the request of the proprietor, be recorded in the Register. The Commission shall adopt implementing acts specifying the details to be contained in a request for the change of name or address pursuant to the first subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 2. A single request may be made for the change of the name or address in respect of two or more registrations of the same proprietor. 3. If the requirements governing the recording of a change are not fulfilled, the Office shall communicate the deficiency to the proprietor of the EU trade mark. If the deficiency is not remedied within a period to be specified by the Office, the Office shall reject the request. 4. Paragraphs 1, 2 and 3 shall also apply to a change of the name or address of the registered representative. 5. Paragraphs 1 to 4 shall apply to applications for EU trade marks. The change shall be recorded in the files kept by the Office on the EU trade mark application. Article 56 Division of the registration 1. The proprietor of the EU trade mark may divide the registration by declaring that some of the goods or services included in the original registration will be the subject of one or more divisional registrations. The goods or services in the divisional registration shall not overlap with the goods or services which remain in the original registration or those which are included in other divisional registrations. 2. The declaration of division shall not be admissible: (a) if, where an application for revocation of rights or for a declaration of invalidity has been entered at the Office against the original registration, such a divisional declaration has the effect of introducing a division amongst the goods or services against which the application for revocation of rights or for a declaration of invalidity is directed, until the decision of the Cancellation Division has become final or the proceedings are finally terminated otherwise; (b) if, where a counterclaim for revocation or for a declaration of invalidity has been entered in a case before an EU trade mark court, such a divisional declaration has the effect of introducing a division amongst the goods or services against which the counterclaim is directed, until the mention of the EU trade mark court's judgment is recorded in the Register pursuant to Article 128(6). 3. If the requirements laid down in paragraph 1 and pursuant to the implementing acts referred to in paragraph 8 are not fulfilled, or the list of goods and services which form the divisional registration overlap with the goods and services which remain in the original registration, the Office shall invite the proprietor of the EU trade mark to remedy the deficiencies within such period as it may specify. If the deficiencies are not remedied before the period expires, the Office shall refuse the declaration of division. 4. The declaration of division shall be subject to a fee. The declaration shall be deemed not to have been made until the fee has been paid. 5. The division shall take effect on the date on which it is entered in the Register. 6. All requests and applications submitted and all fees paid with regard to the original registration prior to the date on which the Office receives the declaration of division shall be deemed also to have been submitted or paid with regard to the divisional registration or registrations. The fees for the original registration which have been duly paid prior to the date on which the declaration of division is received shall not be refunded. 7. The divisional registration shall preserve the filing date and any priority date and seniority date of the original registration. 8. The Commission shall adopt implementing acts specifying: (a) the details to be contained in a declaration of the division of a registration pursuant to paragraph 1; (b) the details as how to process a declaration of the division of a registration, ensuring that a separate file, including a new registration number, is established for the divisional registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). CHAPTER VI SURRENDER, REVOCATION AND INVALIDITY SECTION 1 Surrender Article 57 Surrender 1. An EU trade mark may be surrendered in respect of some or all of the goods or services for which it is registered. 2. The surrender shall be declared to the Office in writing by the proprietor of the trade mark. It shall not have effect until it has been entered in the Register. The validity of the surrender of an EU trade mark which is declared to the Office subsequent to the submission of an application for revocation of that trade mark pursuant to Article 63(1) shall be conditional upon the final rejection or withdrawal of the application for revocation. 3. Surrender shall be entered only with the agreement of the proprietor of a right relating to the EU trade mark and which is entered in the Register. If a licence has been registered, surrender shall be entered in the Register only if the proprietor of the EU trade mark proves that he has informed the licensee of his intention to surrender. The entry of the surrender shall be made on expiry of the three-month period after the date on which the proprietor satisfies the Office that he has informed the licensee of his intention to surrender, or before the expiry of that period, as soon as he proves that the licensee has given his consent. 4. If the requirements governing surrender are not fulfilled, the Office shall communicate the deficiencies to the declarant. If the deficiencies are not remedied within a period to be specified by the Office, the Office shall reject the entry of surrender in the Register. 5. The Commission shall adopt implementing acts specifying the details to be contained in a declaration of surrender pursuant to paragraph 2 of this Article and the kind of documentation required to establish a third party's agreement pursuant to paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). SECTION 2 Grounds for revocation Article 58 Grounds for revocation 1. The rights of the proprietor of the EU trade mark shall be declared to be revoked on application to the Office or on the basis of a counterclaim in infringement proceedings: (a) if, within a continuous period of five years, the trade mark has not been put to genuine use in the Union in connection with the goods or services in respect of which it is registered, and there are no proper reasons for non-use; however, no person may claim that the proprietor's rights in an EU trade mark should be revoked where, during the interval between expiry of the five-year period and filing of the application or counterclaim, genuine use of the trade mark has been started or resumed; the commencement or resumption of use within a period of three months preceding the filing of the application or counterclaim which began at the earliest on expiry of the continuous period of five years of non-use shall, however, be disregarded where preparations for the commencement or resumption occur only after the proprietor becomes aware that the application or counterclaim may be filed; (b) if, in consequence of acts or inactivity of the proprietor, the trade mark has become the common name in the trade for a product or service in respect of which it is registered; (c) if, in consequence of the use made of the trade mark by the proprietor of the trade mark or with his consent in respect of the goods or services for which it is registered, the trade mark is liable to mislead the public, particularly as to the nature, quality or geographical origin of those goods or services. 2. Where the grounds for revocation of rights exist in respect of only some of the goods or services for which the EU trade mark is registered, the rights of the proprietor shall be declared to be revoked in respect of those goods or services only. SECTION 3 Grounds for invalidity Article 59 Absolute grounds for invalidity 1. An EU trade mark shall be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings: (a) where the EU trade mark has been registered contrary to the provisions of Article 7; (b) where the applicant was acting in bad faith when he filed the application for the trade mark. 2. Where the EU trade mark has been registered in breach of the provisions of Article 7(1)(b), (c) or (d), it may nevertheless not be declared invalid if, in consequence of the use which has been made of it, it has after registration acquired a distinctive character in relation to the goods or services for which it is registered. 3. Where the ground for invalidity exists in respect of only some of the goods or services for which the EU trade mark is registered, the trade mark shall be declared invalid as regards those goods or services only. Article 60 Relative grounds for invalidity 1. An EU trade mark shall be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings: (a) where there is an earlier trade mark as referred to in Article 8(2) and the conditions set out in paragraph 1 or 5 of that Article are fulfilled; (b) where there is a trade mark as referred to in Article 8(3) and the conditions set out in that paragraph are fulfilled; (c) where there is an earlier right as referred to in Article 8(4) and the conditions set out in that paragraph are fulfilled; (d) where there is an earlier designation of origin or geographical indication as referred to in Article 8(6) and the conditions set out in that paragraph are fulfilled. All the conditions referred to in the first subparagraph shall be fulfilled at the filing date or the priority date of the EU trade mark. 2. An EU trade mark shall also be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings where the use of such trade mark may be prohibited pursuant to another earlier right under the Union legislation or national law governing its protection, and in particular: (a) a right to a name; (b) a right of personal portrayal; (c) a copyright; (d) an industrial property right. 3. An EU trade mark may not be declared invalid where the proprietor of a right referred to in paragraph 1 or 2 consents expressly to the registration of the EU trade mark before submission of the application for a declaration of invalidity or the counterclaim. 4. Where the proprietor of one of the rights referred to in paragraph 1 or 2 has previously applied for a declaration that an EU trade mark is invalid or made a counterclaim in infringement proceedings, he may not submit a new application for a declaration of invalidity or lodge a counterclaim on the basis of another of the said rights which he could have invoked in support of his first application or counterclaim. 5. Article 59(3) shall apply. Article 61 Limitation in consequence of acquiescence 1. Where the proprietor of an EU trade mark has acquiesced, for a period of five successive years, in the use of a later EU trade mark in the Union while being aware of such use, he shall no longer be entitled on the basis of the earlier trade mark to apply for a declaration that the later trade mark is invalid in respect of the goods or services for which the later trade mark has been used, unless registration of the later EU trade mark was applied for in bad faith. 2. Where the proprietor of an earlier national trade mark as referred to in Article 8(2) or of another earlier sign referred to in Article 8(4) has acquiesced, for a period of five successive years, in the use of a later EU trade mark in the Member State in which the earlier trade mark or the other earlier sign is protected while being aware of such use, he shall no longer be entitled on the basis of the earlier trade mark or of the other earlier sign to apply for a declaration that the later trade mark is invalid in respect of the goods or services for which the later trade mark has been used, unless registration of the later EU trade mark was applied for in bad faith. 3. In the cases referred to in paragraphs 1 and 2, the proprietor of a later EU trade mark shall not be entitled to oppose the use of the earlier right, even though that right may no longer be invoked against the later EU trade mark. SECTION 4 Consequences of revocation and invalidity Article 62 Consequences of revocation and invalidity 1. The EU trade mark shall be deemed not to have had, as from the date of the application for revocation or of the counterclaim, the effects specified in this Regulation, to the extent that the rights of the proprietor have been revoked. An earlier date, on which one of the grounds for revocation occurred, may be fixed in the decision at the request of one of the parties. 2. The EU trade mark shall be deemed not to have had, as from the outset, the effects specified in this Regulation, to the extent that the trade mark has been declared invalid. 3. Subject to the national provisions relating either to claims for compensation for damage caused by negligence or lack of good faith on the part of the proprietor of the trade mark, or to unjust enrichment, the retroactive effect of revocation or invalidity of the trade mark shall not affect: (a) any decision on infringement which has acquired the authority of a final decision and been enforced prior to the revocation or invalidity decision; (b) any contract concluded prior to the revocation or invalidity decision, in so far as it has been performed before that decision; however, repayment, to an extent justified by the circumstances, of sums paid under the relevant contract may be claimed on grounds of equity. SECTION 5 Proceedings in the office in relation to revocation or invalidity Article 63 Application for revocation or for a declaration of invalidity 1. An application for revocation of the rights of the proprietor of an EU trade mark or for a declaration that the trade mark is invalid may be submitted to the Office: (a) where Articles 58 and 59 apply, by any natural or legal person and any group or body set up for the purpose of representing the interests of manufacturers, producers, suppliers of services, traders or consumers, which, under the terms of the law governing it, has the capacity in its own name to sue and be sued; (b) where Article 60(1) applies, by the persons referred to in Article 46(1); (c) where Article 60(2) applies, by the owners of the earlier rights referred to in that provision or by the persons who are entitled under Union legislation or the law of the Member State concerned to exercise the rights in question. 2. The application shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the fee has been paid. 3. An application for revocation or for a declaration of invalidity shall be inadmissible where an application relating to the same subject matter and cause of action, and involving the same parties, has been adjudicated on its merits, either by the Office or by an EU trade mark court as referred to in Article 123, and the decision of the Office or that court on that application has acquired the authority of a final decision. Article 64 Examination of the application 1. On the examination of the application for revocation of rights or for a declaration of invalidity, the Office shall invite the parties, as often as necessary, to file observations, within a period to be fixed by the Office, on communications from the other parties or issued by itself. 2. If the proprietor of the EU trade mark so requests, the proprietor of an earlier EU trade mark, being a party to the invalidity proceedings, shall furnish proof that, during the period of five years preceding the date of the application for a declaration of invalidity, the earlier EU trade mark has been put to genuine use in the Union in connection with the goods or services in respect of which it is registered and which the proprietor of that earlier trade mark cites as justification for his application, or that there are proper reasons for non-use, provided that the earlier EU trade mark has at that date been registered for not less than five years. If, at the date on which the EU trade mark application was filed or at the priority date of the EU trade mark application, the earlier EU trade mark had been registered for not less than five years, the proprietor of the earlier EU trade mark shall furnish proof that, in addition, the conditions set out in Article 47(2) were satisfied at that date. In the absence of proof to this effect, the application for a declaration of invalidity shall be rejected. If the earlier EU trade mark has been used only in relation to part of the goods or services for which it is registered, it shall, for the purpose of the examination of the application for a declaration of invalidity, be deemed to be registered in respect of that part of the goods or services only. 3. Paragraph 2 shall apply to earlier national trade marks referred to in Article 8(2)(a), by substituting use in the Member State in which the earlier national trade mark is protected for use in the Union. 4. The Office may, if it thinks fit, invite the parties to make a friendly settlement. 5. If the examination of the application for revocation of rights or for a declaration of invalidity reveals that the trade mark should not have been registered in respect of some or all of the goods or services for which it is registered, the rights of the proprietor of the EU trade mark shall be revoked or it shall be declared invalid in respect of those goods or services. Otherwise the application for revocation of rights or for a declaration of invalidity shall be rejected. 6. A record of the Office's decision on the application for revocation of rights or for a declaration of invalidity shall be entered in the Register once it has become final. Article 65 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details of the procedures governing the revocation and declaration of invalidity of an EU trade mark as referred to in Articles 63 and 64, as well as the transfer of an EU trade mark registered in the name of an agent as referred to in Article 21. CHAPTER VII APPEALS Article 66 Decisions subject to appeal 1. An appeal shall lie from decisions of any of the decision-making instances of the Office listed in points (a) to (d) of Article 159, and, where appropriate, point (f) of that Article. Those decisions shall take effect only as from the date of expiration of the appeal period referred to in Article 68. The filing of the appeal shall have suspensive effect. 2. A decision which does not terminate proceedings as regards one of the parties can only be appealed together with the final decision, unless the decision allows separate appeal. Article 67 Persons entitled to appeal and to be parties to appeal proceedings Any party to proceedings adversely affected by a decision may appeal. Any other parties to the proceedings shall be parties to the appeal proceedings as of right. Article 68 Time limit and form of appeal 1. Notice of appeal shall be filed in writing at the Office within two months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. It shall be filed in the language of the proceedings in which the decision subject to appeal was taken. Within four months of the date of notification of the decision, a written statement setting out the grounds of appeal shall be filed. 2. In inter partes proceedings, the defendant may, in his response, seek a decision annulling or altering the contested decision on a point not raised in the appeal. Such submissions shall cease to have effect should the appellant discontinue the proceedings. Article 69 Revision of decisions in ex parte cases 1. If the party which has lodged the appeal is the sole party to the procedure, and if the department whose decision is contested considers the appeal to be admissible and well founded, the department shall rectify its decision. 2. If the decision is not rectified within one month of receipt of the statement of grounds, the appeal shall be remitted to the Board of Appeal without delay, and without comment as to its merit. Article 70 Examination of appeals 1. If the appeal is admissible, the Board of Appeal shall examine whether the appeal is allowable. 2. In the examination of the appeal, the Board of Appeal shall invite the parties, as often as necessary, to file observations, within a period to be fixed by the Board of Appeal, on communications from the other parties or issued by itself. Article 71 Decisions in respect of appeals 1. Following the examination as to the allowability of the appeal, the Board of Appeal shall decide on the appeal. The Board of Appeal may either exercise any power within the competence of the department which was responsible for the decision appealed or remit the case to that department for further prosecution. 2. If the Board of Appeal remits the case for further prosecution to the department whose decision was appealed, that department shall be bound by the ratio decidendi of the Board of Appeal, in so far as the facts are the same. 3. The decisions of the Board of Appeal shall take effect only as from the date of expiry of the period referred to in Article 72(5) or, if an action has been brought before the General Court within that period, as from the date of dismissal of such action or of any appeal filed with the Court of Justice against the decision of the General Court. Article 72 Actions before the Court of Justice 1. Actions may be brought before the General Court against decisions of the Boards of Appeal in relation to appeals. 2. The action may be brought on grounds of lack of competence, infringement of an essential procedural requirement, infringement of the TFEU, infringement of this Regulation or of any rule of law relating to their application or misuse of power. 3. The General Court shall have jurisdiction to annul or to alter the contested decision. 4. The action shall be open to any party to proceedings before the Board of Appeal adversely affected by its decision. 5. The action shall be brought before the General Court within two months of the date of notification of the decision of the Board of Appeal. 6. The Office shall take the necessary measures to comply with the judgment of the General Court or, in the event of an appeal against that judgment, the Court of Justice. Article 73 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying: (a) the formal content of the notice of appeal referred to in Article 68 and the procedure for the filing and the examination of an appeal; (b) the formal content and form of the Board of Appeal's decisions as referred to in Article 71; (c) the reimbursement of the appeal fee referred to in Article 68. CHAPTER VIII SPECIFIC PROVISIONS ON EUROPEAN UNION COLLECTIVE MARKS AND CERTIFICATION MARKS SECTION 1 EU collective marks Article 74 EU collective marks 1. A European Union collective mark (\u2018EU collective mark\u2019) shall be an EU trade mark which is described as such when the mark is applied for and is capable of distinguishing the goods or services of the members of the association which is the proprietor of the mark from those of other undertakings. Associations of manufacturers, producers, suppliers of services, or traders which, under the terms of the law governing them, have the capacity in their own name to have rights and obligations of all kinds, to make contracts or accomplish other legal acts, and to sue and be sued, as well as legal persons governed by public law, may apply for EU collective marks. 2. By way of derogation from Article 7(1)(c), signs or indications which may serve, in trade, to designate the geographical origin of the goods or services may constitute EU collective marks within the meaning of paragraph 1. An EU collective mark shall not entitle the proprietor to prohibit a third party from using in the course of trade such signs or indications, provided that he uses them in accordance with honest practices in industrial or commercial matters; in particular, such a mark shall not be invoked against a third party who is entitled to use a geographical name. 3. Chapters I to VII and IX to XIV shall apply to EU collective marks to the extent that this section does not provide otherwise. Article 75 Regulations governing use of an EU collective mark 1. An applicant for an EU collective mark shall submit regulations governing use within two months of the date of filing. 2. The regulations governing use shall specify the persons authorised to use the mark, the conditions of membership of the association and, where they exist, the conditions of use of the mark, including sanctions. The regulations governing use of a mark referred to in Article 74(2) shall authorise any person whose goods or services originate in the geographical area concerned to become a member of the association which is the proprietor of the mark. 3. The Commission shall adopt implementing acts specifying the details to be contained in the regulations referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 76 Refusal of the application 1. In addition to the grounds for refusal of an EU trade mark application provided for in Articles 41 and 42, an application for an EU collective mark shall be refused where the provisions of Articles 74 or 75 are not satisfied, or where the regulations governing use are contrary to public policy or to accepted principles of morality. 2. An application for an EU collective mark shall also be refused if the public is liable to be misled as regards the character or the significance of the mark, in particular if it is likely to be taken to be something other than a collective mark. 3. An application shall not be refused if the applicant, as a result of amendment of the regulations governing use, meets the requirements of paragraphs 1 and 2. Article 77 Observations by third parties Where written observations on an EU collective mark are submitted to the Office pursuant to Article 45, those observations may also be based on the particular grounds on which the application for an EU collective mark should be refused pursuant to Article 76. Article 78 Use of marks Use of an EU collective mark by any person who has authority to use it shall satisfy the requirements of this Regulation, provided that the other conditions which this Regulation imposes with regard to the use of EU trade marks are fulfilled. Article 79 Amendment of the regulations governing use of the EU collective mark 1. The proprietor of an EU collective mark shall submit to the Office any amended regulations governing use. 2. The amendment shall not be mentioned in the Register if the amended regulations do not satisfy the requirements of Article 75 or involve one of the grounds for refusal referred to in Article 76. 3. Written observations made in accordance with Article 77 may also be submitted with regard to amended regulations governing use. 4. For the purposes of applying this Regulation, amendments to the regulations governing use shall take effect only from the date of entry of the mention of the amendment in the Register. Article 80 Persons who are entitled to bring an action for infringement 1. The provisions of Article 25(3) and (4) concerning the rights of licensees shall apply to every person who has authority to use an EU collective mark. 2. The proprietor of an EU collective mark shall be entitled to claim compensation on behalf of persons who have authority to use the mark where they have sustained damage in consequence of unauthorised use of the mark. Article 81 Grounds for revocation Apart from the grounds for revocation provided for in Article 58, the rights of the proprietor of an EU collective mark shall be revoked on application to the Office or on the basis of a counterclaim in infringement proceedings, if: (a) the proprietor does not take reasonable steps to prevent the mark being used in a manner incompatible with the conditions of use, where these exist, laid down in the regulations governing use, amendments to which have, where appropriate, been mentioned in the Register; (b) the manner in which the mark has been used by the proprietor has caused it to become liable to mislead the public in the manner referred to in Article 76(2); (c) an amendment to the regulations governing use of the mark has been mentioned in the Register in breach of the provisions of Article 79(2), unless the proprietor of the mark, by further amending the regulations governing use, complies with the requirements of those provisions. Article 82 Grounds for invalidity Apart from the grounds for invalidity provided for in Articles 59 and 60, an EU collective mark which is registered in breach of the provisions of Article 76 shall be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings, unless the proprietor of the mark, by amending the regulations governing use, complies with the requirements of those provisions. SECTION 2 EU certification marks Article 83 EU certification marks 1. An EU certification mark shall be an EU trade mark which is described as such when the mark is applied for and is capable of distinguishing goods or services which are certified by the proprietor of the mark in respect of material, mode of manufacture of goods or performance of services, quality, accuracy or other characteristics, with the exception of geographical origin, from goods and services which are not so certified. 2. Any natural or legal person, including institutions, authorities and bodies governed by public law, may apply for EU certification marks provided that such person does not carry on a business involving the supply of goods or services of the kind certified. 3. Chapters I to VII and IX to XIV shall apply to EU certification marks to the extent that this Section does not provide otherwise. Article 84 Regulations governing use of an EU certification mark 1. An applicant for an EU certification mark shall submit regulations governing the use of the EU certification mark within two months of the date of filing. 2. The regulations governing use shall specify the persons authorised to use the mark, the characteristics to be certified by the mark, how the certifying body is to test those characteristics and to supervise the use of the mark. Those regulations shall also specify the conditions of use of the mark, including sanctions. 3. The Commission shall adopt implementing acts specifying the details to be contained in the regulations referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 85 Refusal of the application 1. In addition to the grounds for refusal of an EU trade mark application provided for in Articles 41 and 42, an application for an EU certification mark shall be refused where the conditions set out in Articles 83 and 84 are not satisfied, or where the regulations governing use are contrary to public policy or to accepted principles of morality. 2. An application for an EU certification mark shall also be refused if the public is liable to be misled as regards the character or the significance of the mark, in particular if it is likely to be taken to be something other than a certification mark. 3. An application shall not be refused if the applicant, as a result of an amendment of the regulations governing use, meets the requirements of paragraphs 1 and 2. Article 86 Observations by third parties Where written observations on an EU certification mark are submitted to the Office pursuant to Article 45, those observations may also be based on the particular grounds on which the application for an EU certification mark should be refused pursuant to Article 85. Article 87 Use of the EU certification mark Use of an EU certification mark by any person who has authority to use it pursuant to the regulations governing use referred to in Article 84 shall satisfy the requirements of this Regulation, provided that the other conditions laid down in this Regulation with regard to the use of EU trade marks are fulfilled. Article 88 Amendment of the regulations governing use of the EU certification mark 1. The proprietor of an EU certification mark shall submit to the Office any amended regulations governing use. 2. Amendments shall not be mentioned in the Register where the regulations as amended do not satisfy the requirements of Article 84 or involve one of the grounds for refusal referred to in Article 85. 3. Written observations in accordance with Article 86 may also be submitted with regard to amended regulations governing use. 4. For the purposes of this Regulation, amendments to the regulations governing use shall take effect only as from the date of entry of the mention of the amendment in the Register. Article 89 Transfer By way of derogation from Article 20(1), an EU certification mark may only be transferred to a person who meets the requirements of Article 83(2). Article 90 Persons who are entitled to bring an action for infringement 1. Only the proprietor of an EU certification mark, or any person specifically authorised by him to that effect, shall be entitled to bring an action for infringement. 2. The proprietor of an EU certification mark shall be entitled to claim compensation on behalf of persons who have authority to use the mark where they have sustained damage as a consequence of unauthorised use of the mark. Article 91 Grounds for revocation In addition to the grounds for revocation provided for in Article 58, the rights of the proprietor of an EU certification mark shall be revoked on application to the Office or on the basis of a counterclaim in infringement proceedings, where any of the following conditions is fulfilled: (a) the proprietor no longer complies with the requirements set out in Article 83(2); (b) the proprietor does not take reasonable steps to prevent the EU certification mark being used in a manner that is incompatible with the conditions of use laid down in the regulations governing use, amendments to which have, where appropriate, been mentioned in the Register; (c) the manner in which the EU certification mark has been used by the proprietor has caused it to become liable to mislead the public in the manner referred to in Article 85(2); (d) an amendment to the regulations governing use of the EU certification mark has been mentioned in the Register in breach of Article 88(2), unless the proprietor of the mark, by further amending the regulations governing use, complies with the requirements of that Article. Article 92 Grounds for invalidity In addition to the grounds for invalidity provided for in Articles 59 and 60, an EU certification mark which is registered in breach of Article 85 shall be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings, unless the proprietor of the EU certification mark, by amending the regulations governing use, complies with the requirements of Article 85. Article 93 Conversion Without prejudice to Article 139(2), conversion of an application for an EU certification mark or of a registered EU certification mark shall not take place where the national law of the Member State concerned does not provide for the registration of guarantee or certification marks pursuant to Article 28 of Directive (EU) 2015/2436. CHAPTER IX PROCEDURE SECTION 1 General provisions Article 94 Decisions and communications of the Office 1. Decisions of the Office shall state the reasons on which they are based. They shall be based only on reasons or evidence on which the parties concerned have had an opportunity to present their comments. Where oral proceedings are held before the Office, the decision may be given orally. Subsequently, the decision shall be notified in writing to the parties. 2. Any decision, communication or notice from the Office shall indicate the department or division of the Office as well as the name or the names of the official or officials responsible. They shall be signed by that official or those officials, or, instead of a signature, carry a printed or stamped seal of the Office. The Executive Director may determine that other means of identifying the department or division of the Office and the name of the official or officials responsible, or an identification other than a seal, may be used where decisions, communications or notices from the Office are transmitted by telecopier or any other technical means of communication. 3. Decisions of the Office which are open to appeal shall be accompanied by a written communication indicating that any notice of appeal is to be filed in writing at the Office within two months of the date of notification of the decision in question. The communications shall also draw the attention of the parties to the provisions laid down in Articles 66, 67 and 68. The parties may not plead any failure on the part of the Office to communicate the availability of appeal proceedings. Article 95 Examination of the facts by the Office of its own motion 1. In proceedings before it the Office shall examine the facts of its own motion; however, in proceedings relating to relative grounds for refusal of registration, the Office shall be restricted in this examination to the facts, evidence and arguments provided by the parties and the relief sought. In invalidity proceedings pursuant to Article 59, the Office shall limit its examination to the grounds and arguments submitted by the parties. 2. The Office may disregard facts or evidence which are not submitted in due time by the parties concerned. Article 96 Oral proceedings 1. If the Office considers that oral proceedings would be expedient they shall be held either at the instance of the Office or at the request of any party to the proceedings. 2. Oral proceedings before the examiners, the Opposition Division and the Department in charge of the Register shall not be public. 3. Oral proceedings, including delivery of the decision, shall be public before the Cancellation Division and the Boards of Appeal, in so far as the department before which the proceedings are taking place does not decide otherwise in cases where admission of the public could have serious and unjustified disadvantages, in particular for a party to the proceedings. 4. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the detailed arrangements for oral proceedings, including the detailed arrangements for the use of languages in accordance with Article 146. Article 97 Taking of evidence 1. In any proceedings before the Office, the means of giving or obtaining evidence shall include the following: (a) hearing the parties; (b) requests for information; (c) the production of documents and items of evidence; (d) hearing witnesses; (e) opinions by experts; (f) statements in writing sworn or affirmed or having a similar effect under the law of the State in which the statement is drawn up. 2. The relevant department may commission one of its members to examine the evidence adduced. 3. If the Office considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. The period of notice provided in such summons shall be at least one month, unless they agree to a shorter period. 4. The parties shall be informed of the hearing of a witness or expert before the Office. They shall have the right to be present and to put questions to the witness or expert. 5. The Executive Director shall determine the amounts of expenses to be paid, including advances, as regards the costs of taking of evidence as referred to in this Article. 6. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the detailed arrangements for the taking of evidence. Article 98 Notification 1. The Office shall, as a matter of course, notify those concerned of decisions and summonses and of any notice or other communication from which a time limit is reckoned, or of which those concerned are to be notified under other provisions of this Regulation or of acts adopted pursuant to this Regulation, or of which notification has been ordered by the Executive Director. 2. The Executive Director may determine which documents other than decisions subject to a time limit for appeal and summonses shall be notified by registered letter with proof of delivery. 3. Notification may be effected by different means, including by electronic means. The details regarding electronic means shall be determined by the Executive Director. 4. Where notification is to be effected by public notice, the Executive Director shall determine how the public notice is to be given and shall fix the beginning of the one-month period on the expiry of which the document shall be deemed to have been notified. 5. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the detailed arrangements for notification. Article 99 Notification of loss of rights Where the Office finds that the loss of any rights results from this Regulation or acts adopted pursuant to this Regulation, without any decision having been taken, it shall communicate this to the person concerned in accordance with Article 98. The latter may apply for a decision on the matter within two months of notification of the communication, if he considers that the finding of the Office is incorrect. The Office shall adopt such a decision only where it disagrees with the person requesting it; otherwise the Office shall amend its finding and inform the person requesting the decision. Article 100 Communications to the Office 1. Communications addressed to the Office may be effected by electronic means. The Executive Director shall determine to what extent and under which technical conditions those communications may be submitted electronically. 2. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the rules on the means of communication, including the electronic means of communication, to be used by the parties to proceedings before the Office and the forms to be made available by the Office. Article 101 Time limits 1. Time limits shall be laid down in terms of full years, months, weeks or days. Calculation shall start on the day following the day on which the relevant event occurred. The duration of time limits shall be no less than one month and no more than six months. 2. The Executive Director shall determine, before the commencement of each calendar year, the days on which the Office is not open for receipt of documents or on which ordinary post is not delivered in the locality in which the Office is located. 3. The Executive Director shall determine the duration of the period of interruption in the case of a general interruption in the delivery of post in the Member State where the Office is located or, in the case of an actual interruption of the Office's connection to admitted electronic means of communication. 4. If an exceptional occurrence, such as a natural disaster or strike, interrupts or interferes with proper communication from the parties to the proceedings to the Office or vice-versa, the Executive Director may determine that for parties to the proceedings having their residence or registered office in the Member State concerned or who have appointed a representative with a place of business in the Member State concerned all time limits that otherwise would expire on or after the date of commencement of such occurrence, as determined by him, shall extend until a date to be determined by him. When determining that date, he shall assess when the exceptional occurrence comes to an end. If the occurrence affects the seat of the Office, such determination of the Executive Director shall specify that it applies in respect of all parties to the proceedings. 5. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details regarding the calculation and duration of time limits. Article 102 Correction of errors and manifest oversights 1. The Office shall correct any linguistic errors or errors of transcription and manifest oversights in its decisions, or technical errors attributable to it in registering an EU trade mark or in publishing the registration of its own motion or at the request of a party. 2. Where the correction of errors in the registration of an EU trade mark or the publication of the registration is requested by the proprietor, Article 55 shall apply mutatis mutandis. 3. Corrections of errors in the registration of an EU trade mark and in the publication of the registration shall be published by the Office. Article 103 Revocation of decisions 1. Where the Office has made an entry in the Register or taken a decision which contains an obvious error attributable to the Office, it shall ensure that the entry is cancelled or the decision is revoked. Where there is only one party to the proceedings and the entry or the act affects its rights, cancellation or revocation shall be determined even if the error was not evident to the party. 2. Cancellation or revocation as referred to in paragraph 1 shall be determined, ex officio or at the request of one of the parties to the proceedings, by the department which made the entry or took the decision. The cancellation of the entry in the Register or the revocation of the decision shall be effected within one year of the date on which the entry was made in the Register or that decision was taken, after consultation with the parties to the proceedings and any proprietor of rights to the EU trade mark in question that are entered in the Register. The Office shall keep records of any such cancellation or revocation. 3. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the procedure for the revocation of a decision or for the cancellation of an entry in the Register. 4. This Article shall be without prejudice to the right of the parties to submit an appeal under Articles 66 and 72, or to the possibility of correcting errors and manifest oversights under Article 102. Where an appeal has been filed against a decision of the Office containing an error, the appeal proceedings shall become devoid of purpose upon revocation by the Office of its decision pursuant to paragraph 1 of this Article. In the latter case, the appeal fee shall be reimbursed to the appellant. Article 104 Restitutio in integrum 1. The applicant for or proprietor of an EU trade mark or any other party to proceedings before the Office who, in spite of all due care required by the circumstances having been taken, was unable to comply with a time limit vis-\u00e0-vis the Office shall, upon application, have his rights re-established if the obstacle to compliance has the direct consequence, by virtue of the provisions of this Regulation, of causing the loss of any right or means of redress. 2. The application shall be filed in writing within two months of the removal of the obstacle to compliance with the time limit. The omitted act shall be completed within this period. The application shall only be admissible within the year immediately following the expiry of the unobserved time limit. In the case of non-submission of the request for renewal of registration or of non-payment of a renewal fee, the further period of six months provided in the third sentence of Article 53(3) shall be deducted from the period of one year. 3. The application shall state the grounds on which it is based and shall set out the facts on which it relies. It shall not be deemed to be filed until the fee for re-establishment of rights has been paid. 4. The department competent to decide on the omitted act shall decide upon the application. 5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article, Article 46(1) and (3) and Article 105. 6. Where the applicant for or proprietor of an EU trade mark has his rights re-established, he may not invoke his rights vis-\u00e0-vis a third party who, in good faith, has put goods on the market or supplied services under a sign which is identical with, or similar to, the EU trade mark in the course of the period between the loss of rights in the application or in the EU trade mark and publication of the mention of re-establishment of those rights. 7. A third party who may avail himself of the provisions of paragraph 6 may bring third party proceedings against the decision re-establishing the rights of the applicant for or proprietor of an EU trade mark within a period of two months as from the date of publication of the mention of re-establishment of those rights. 8. Nothing in this Article shall limit the right of a Member State to grant restitutio in integrum in respect of time limits provided for in this Regulation and to be observed vis-\u00e0-vis the authorities of such State. Article 105 Continuation of proceedings 1. An applicant for or proprietor of an EU trade mark or any other party to proceedings before the Office who has omitted to observe a time limit vis-\u00e0-vis the Office may, upon request, obtain the continuation of proceedings, provided that at the time the request is made the omitted act has been carried out. The request for continuation of proceedings shall be admissible only if it is submitted within two months of the expiry of the unobserved time limit. The request shall not be deemed to have been filed until the fee for continuation of the proceedings has been paid. 2. This Article shall not apply to the time limits laid down in Article 32, Article 34(1), Article 38(1), Article 41(2), Article 46(1) and (3), Article 53(3), Article 68, Article 72(5), Article 104(2) and Article 139, or to the time limits laid down in paragraph 1 of this Article or the time limit for claiming seniority pursuant to Article 39 after the application has been filed. 3. The department competent to decide on the omitted act shall decide upon the application. 4. If the Office accepts the application, the consequences of having failed to observe the time limit shall be deemed not to have occurred. If a decision has been taken between the expiry of that time limit and the request for the continuation of proceedings, the department competent to decide on the omitted act shall review the decision and, where completion of the omitted act itself is sufficient, take a different decision. If, following the review, the Office concludes that the original decision does not require to be altered, it shall confirm that decision in writing. 5. If the Office rejects the application, the fee shall be refunded. Article 106 Interruption of proceedings 1. Proceedings before the Office shall be interrupted: (a) in the event of the death or legal incapacity of the applicant for, or proprietor of, an EU trade mark or of the person authorised by national law to act on his behalf. To the extent that that death or incapacity does not affect the authorisation of a representative appointed under Article 120, proceedings shall be interrupted only on application by such representative; (b) in the event of the applicant for, or proprietor of, an EU trade mark being prevented, for legal reasons resulting from action taken against his property, from continuing the proceedings before the Office; (c) in the event of the death or legal incapacity of the representative of an applicant for, or proprietor of, an EU trade mark, or of that representative being prevented, for legal reasons resulting from action taken against his property, from continuing the proceedings before the Office. 2. Proceedings before the Office shall be resumed as soon as the identity of the person authorised to continue them has been established. 3. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the detailed arrangements for the resumption of proceedings before the Office. Article 107 Reference to general principles In the absence of procedural provisions in this Regulation or in acts adopted pursuant to this Regulation, the Office shall take into account the principles of procedural law generally recognised in the Member States. Article 108 Termination of financial obligations 1. Rights of the Office to the payment of a fee shall be extinguished after four years from the end of the calendar year in which the fee fell due. 2. Rights against the Office for the refunding of fees or sums of money paid in excess of a fee shall be extinguished after four years from the end of the calendar year in which the right arose. 3. The period laid down in paragraphs 1 and 2 shall be interrupted, in the case covered by paragraph 1, by a request for payment of the fee, and in the case covered by paragraph 2, by a reasoned claim in writing. On interruption it shall begin again immediately and shall end at the latest six years after the end of the year in which it originally began, unless, in the meantime, judicial proceedings to enforce the right have begun; in this case the period shall end at the earliest one year after the judgment has acquired the authority of a final decision. SECTION 2 Costs Article 109 Costs 1. The losing party in opposition proceedings, proceedings for revocation, proceedings for a declaration of invalidity or appeal proceedings shall bear the fees paid by the other party. Without prejudice to Article 146(7), the losing party shall also bear all costs incurred by the other party that are essential to the proceedings, including travel and subsistence and the remuneration of a representative within the meaning of Article 120(1), within the limits of the scales set for each category of costs in the implementing act to be adopted in accordance with paragraph 2 of this Article. The fees to be borne by the losing party shall be limited to the fees paid by the other party for opposition, for an application for revocation or for a declaration of invalidity of the EU trade mark and for appeal. 2. The Commission shall adopt implementing acts specifying the maximum rates for costs essential to the proceedings and actually incurred by the successful party. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). When specifying such amounts with respect to travel and subsistence costs, the Commission shall take into account the distance between the place of residence or business of the party, representative or witness or expert and the place where the oral proceedings are held, the procedural stage at which the costs have been incurred, and, as far as costs of representation within the meaning of Article 120(1) are concerned, the need to ensure that the obligation to bear the costs may not be misused for tactical reasons by the other party. Subsistence expenses shall be calculated in accordance with the Staff Regulations of Officials of the Union and the Conditions of Employment of Other Servants of the Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (15) (\u2018the Staff Regulations\u2019 and \u2018Conditions of Employment\u2019 respectively). The losing party shall bear the costs for one opposing party only and, where applicable, one representative only. 3. However, where each party succeeds on some and fails on other heads, or if reasons of equity so dictate, the Opposition Division, Cancellation Division or Board of Appeal shall decide a different apportionment of costs. 4. The party who terminates the proceedings by withdrawing the EU trade mark application, the opposition, the application for revocation of rights, the application for a declaration of invalidity or the appeal, or by not renewing registration of the EU trade mark or by surrendering the EU trade mark, shall bear the fees and the costs incurred by the other party as stipulated in paragraphs 1 and 3. 5. Where a case does not proceed to judgment the costs shall be at the discretion of the Opposition Division, Cancellation Division or Board of Appeal. 6. Where the parties conclude before the Opposition Division, Cancellation Division or Board of Appeal a settlement of costs differing from that provided for in paragraphs 1 to 5, the department concerned shall take note of that agreement. 7. The Opposition Division or Cancellation Division or Board of Appeal shall fix the amount of the costs to be paid pursuant to paragraphs 1 to 6 of this Article when the costs to be paid are limited to the fees paid to the Office and the representation costs. In all other cases, the registry of the Board of Appeal or a member of the staff of the Opposition Division or Cancellation Division shall fix, on request, the amount of the costs to be reimbursed. The request shall be admissible only for the period of two months following the date on which the decision for which an application was made for the costs to be fixed becomes final and shall be accompanied by a bill and supporting evidence. For the costs of representation pursuant to Article 120(1), an assurance by the representative that the costs have been incurred shall be sufficient. For other costs, it shall be sufficient if their plausibility is established. Where the amount of the costs is fixed pursuant to the first sentence of this paragraph, representation costs shall be awarded at the level laid down in the implementing act adopted pursuant to paragraph 2 of this Article and irrespective of whether they have been actually incurred. 8. The decision on the fixing of costs, stating the reasons on which it is based, may be reviewed by a decision of the Opposition Division or Cancellation Division or Board of Appeal on a request filed within one month of the date of notification of the awarding of costs. It shall not be deemed to be filed until the fee for reviewing the amount of the costs has been paid. The Opposition Division, the Cancellation Division or the Board of Appeal, as the case may be, shall take a decision on the request for a review of the decision on the fixing of costs without oral proceedings. Article 110 Enforcement of decisions fixing the amount of costs 1. Any final decision of the Office fixing the amount of costs shall be enforceable. 2. Enforcement shall be governed by the rules of civil procedure in force in the State in the territory of which it is carried out. Each Member State shall designate a single authority responsible for verifying the authenticity of the decision referred to in paragraph 1 and shall communicate its contact details to the Office, the Court of Justice and the Commission. The order for the enforcement of the decision shall be appended to the decision by that authority, with the verification of the authenticity of the decision as the sole formality. 3. When these formalities have been completed on application by the party concerned, the latter may proceed to enforcement in accordance with the national law, by bringing the matter directly before the competent authority. 4. Enforcement may be suspended only by a decision of the Court of Justice. However, the courts of the country concerned shall have jurisdiction over complaints that enforcement is being carried out in an irregular manner. SECTION 3 Information which may be made available to the public and to the authorities of the Member States Article 111 Register of EU trade marks 1. The Office shall keep a Register of EU trade marks which it shall keep up to date. 2. The Register shall contain the following entries relating to EU trade mark applications and registrations: (a) the date of filing the application; (b) the file number of the application; (c) the date of the publication of the application; (d) the name and address of the applicant; (e) the name and business address of the representative, other than a representative as referred to in the first sentence of Article 119(3); (f) the representation of the mark, with indications as to its nature; and, where applicable, a description of the mark; (g) an indication of the goods and services by their names; (h) particulars of claims of priority pursuant to Article 35; (i) particulars of claims of exhibition priority pursuant to Article 38; (j) particulars of claims of seniority of a registered earlier trade mark as referred to in Article 39; (k) a statement that the mark has become distinctive in consequence of the use which has been made of it, pursuant to Article 7(3); (l) an indication that the mark is a collective mark; (m) an indication that the mark is a certification mark; (n) the language in which the application was filed and the second language which the applicant has indicated in his application, pursuant to Article 146(3); (o) the date of registration of the mark in the Register and the registration number; (p) a statement that the application is the result of a transformation of an international registration designating the Union, pursuant to Article 204 of this Regulation, together with the date of the international registration pursuant to Article 3(4) of the Madrid Protocol or the date on which the territorial extension to the Union made subsequent to the international registration pursuant to Article 3ter(2) of the Madrid Protocol was recorded and, where applicable, the date of priority of the international registration. 3. The Register shall also contain the following entries, each accompanied by the date of recording of such entry: (a) changes in the name, address or nationality of the proprietor of an EU trade mark or a change in the State in which he is domiciled or has his seat or establishment; (b) changes in the name or business address of the representative, other than a representative as referred to in the first sentence of Article 119(3); (c) where a new representative is appointed, the name and business address of that representative; (d) amendments and alterations of the mark, pursuant to Articles 49 and 54, and corrections of errors; (e) notice of amendments to the regulations governing the use of the collective mark pursuant to Article 79; (f) particulars of claims of seniority of a registered earlier trade mark as referred to in Article 39, pursuant to Article 40; (g) total or partial transfers pursuant to Article 20; (h) creation or transfer of a right in rem pursuant to Article 22, and the nature of the right in rem; (i) levy of execution pursuant to Article 23 and insolvency proceedings pursuant to Article 24; (j) the grant or transfer of a licence pursuant to Article 25 and, where applicable, the type of licence; (k) renewal of a registration pursuant to Article 53, the date from which it takes effect and any restrictions pursuant to Article 53(4); (l) a record of a determination of the expiry of a registration pursuant to Article 53; (m) declarations of withdrawal or surrender by the proprietor of the mark pursuant to Articles 49 and 57 respectively; (n) the date of submission and the particulars of an opposition pursuant to Article 46, of an application pursuant to Article 63, or a counterclaim pursuant to Article 128(4) for revocation or for a declaration of invalidity, or of an appeal pursuant to Article 68; (o) the date and content of a decision on an opposition, on an application or counterclaim pursuant to Article 64(6) or the third sentence of Article 128(6), or on an appeal pursuant to Article 71; (p) a record of the receipt of a request for conversion pursuant to Article 140(2); (q) the cancellation of the representative recorded pursuant to point (e) of paragraph 2 of this Article; (r) the cancellation of the seniority of a national mark; (s) the modification to or cancellation from the Register of the items referred to in points (h), (i) and (j) of this paragraph; (t) the replacement of the EU trade mark by an international registration pursuant to Article 197; (u) the date and number of international registrations based on the EU trade mark application which has been registered as an EU trade mark pursuant to Article 185(1); (v) the date and number of international registrations based on the EU trade mark pursuant to Article 185(2); (w) the division of an application pursuant to Article 50 and the division of a registration pursuant to Article 56, together with the items referred to in paragraph 2 of this Article in respect of the divisional registration, as well as the list of goods and services of the original registration as amended; (x) the revocation of a decision or an entry in the Register pursuant to Article 103, where the revocation concerns a decision or entry which has been published; (y) notice of amendments to the regulations governing the use of the EU certification mark pursuant to Article 88. 4. The Executive Director may determine that items other than those referred to in paragraphs 2 and 3 of this Article are to be entered in the Register, subject to Article 149(4). 5. The Register may be maintained in electronic form. The Office shall collect, organise, make public and store the items referred to in paragraphs 2 and 3, including any personal data, for the purposes laid down in paragraph 8. The Office shall keep the register easily accessible for public inspection. 6. The proprietor of an EU trade mark shall be notified of any change in the Register. 7. The Office shall provide certified or uncertified extracts from the Register on request and on payment of a fee. 8. The processing of the data concerning the entries set out in paragraphs 2 and 3, including any personal data, shall take place for the purposes of: (a) administering the applications and/or registrations as described in this Regulation and acts adopted pursuant to it; (b) maintaining a public register for inspection by, and the information of, public authorities and economic operators, in order to enable them to exercise the rights conferred on them by this Regulation and be informed about the existence of prior rights belonging to third parties; and (c) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system. 9. All the data, including personal data, concerning the entries in paragraphs 2 and 3 shall be considered to be of public interest and may be accessed by any third party. For reasons of legal certainty, the entries in the Register shall be kept for an indefinite period of time. Article 112 Database 1. In addition to the obligation to keep a Register within the meaning of Article 111, the Office shall collect and store in an electronic database all the particulars provided by applicants or any other party to the proceedings pursuant to this Regulation or acts adopted pursuant to it. 2. The electronic database may include personal data, beyond those included in the Register pursuant to Article 111, to the extent that such particulars are required by this Regulation or by acts adopted pursuant to it. The collection, storage and processing of such data shall serve the purposes of: (a) administering the applications and/or registrations as described in this Regulation and in acts adopted pursuant to it; (b) accessing the information necessary for conducting the relevant proceedings more easily and efficiently; (c) communicating with the applicants and other parties to the proceedings; (d) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system. 3. The Executive Director shall determine the conditions of access to the electronic database and the manner in which its contents, other than the personal data referred to in paragraph 2 of this Article but including those listed in Article 111, may be made available in machine-readable form, including the charge for such access. 4. Access to the personal data referred to in paragraph 2 shall be restricted and such data shall not be made publicly available unless the party concerned has given his express consent. 5. All data shall be kept indefinitely. However, the party concerned may request the removal of any personal data from the database after 18 months from the expiry of the EU trade mark or the closure of the relevant inter partes procedure. The party concerned shall have the right to obtain the correction of inaccurate or erroneous data at any time. Article 113 Online access to decisions 1. The decisions of the Office shall be made available online for the information and consultation of the general public in the interest of transparency and predictability. Any party to the proceedings that led to the adoption of the decision may request the removal of any personal data included in the decision. 2. The Office may provide online access to judgments of national and Union courts related to its tasks in order to raise public awareness of intellectual property matters and promote convergence of practices. The Office shall respect the conditions of the initial publication with regard to personal data. Article 114 Inspection of files 1. The files relating to EU trade mark applications which have not yet been published shall not be made available for inspection without the consent of the applicant. 2. Any person who can prove that the applicant for an EU trade mark has stated that after the trade mark has been registered he will invoke the rights under it against him may obtain inspection of the files prior to the publication of that application and without the consent of the applicant. 3. Subsequent to the publication of the EU trade mark application, the files relating to such application and the resulting trade mark may be inspected on request. 4. Where the files are inspected pursuant to paragraph 2 or 3 of this Article, documents relating to exclusion or objection pursuant to Article 169, draft decisions and opinions, and all other internal documents used for the preparation of decisions and opinions, as well as parts of the file which the party concerned showed a special interest in keeping confidential before the request for inspection of the files was made, unless inspection of such parts of the file is justified by overriding, legitimate interests of the party seeking inspection, may be withheld from inspection. 5. Inspection of the files of EU trade mark applications and of registered EU trade marks shall be of the original document, or of copies thereof, or of technical means of storage if the files are stored in this way. The Executive Director shall determine the means of inspection. 6. Where inspection of files takes place as provided for in paragraph 7, the request for inspection of the files shall not be deemed to have been made until the required fee has been paid. No fee shall be payable if inspection of technical means of storage takes place online. 7. Inspection of the files shall take place at the premises of the Office. On request, inspection of the files shall be effected by means of issuing copies of file documents. The issuing of such copies shall be conditional on the payment of a fee. The Office shall also issue on request certified or uncertified copies of the application for an EU trade mark upon payment of a fee. 8. The files kept by the Office relating to international registrations designating the Union may be inspected on request as from the date of publication referred to in Article 190(1), in accordance with the conditions laid down in paragraphs 1, 3 and 4 of this Article. 9. Subject to the restrictions provided for in paragraph 4, the Office may, on request, communicate information from any file of an EU trade mark applied for or of a registered EU trade mark, subject to payment of a fee. However, the Office may require the exercise of the option to obtain inspection of the file itself should it deem this to be appropriate in view of the quantity of information to be supplied. Article 115 Keeping of files 1. The Office shall keep the files of any procedure relating to an EU trade mark application or EU trade mark registration. The Executive Director shall determine the form in which those files shall be kept. 2. Where the files are kept in electronic format, the electronic files, or back-up copies thereof, shall be kept indefinitely. The original documents filed by parties to the proceedings, and forming the basis of such electronic files, shall be disposed of after a period following their reception by the Office, which shall be determined by the Executive Director. 3. Where and to the extent that files or parts of the files are kept in any form other than electronically, documents or items of evidence constituting part of such files shall be kept for at least five years from the end of the year in which the application is rejected or withdrawn or is deemed to be withdrawn, the registration of the EU trade mark expires completely pursuant to Article 53, the complete surrender of the EU trade mark is registered pursuant to Article 57, or the EU trade mark is completely removed from the Register pursuant to Article 64(6) or 128(6). Article 116 Periodical publications 1. The Office shall periodically publish: (a) a European Union Trade Marks Bulletin containing publications of applications and of entries made in the Register as well as other particulars relating to applications or registrations of EU trade marks the publication of which is required under this Regulation or by acts adopted pursuant to it; (b) an Official Journal of the Office containing notices and information of a general character issued by the Executive Director, as well as any other information relevant to this Regulation or its implementation. The publications referred to in points (a) and (b) of the first subparagraph may be effected by electronic means. 2. The European Union Trade Marks Bulletin shall be published in a manner and at a frequency to be determined by the Executive Director. 3. The Official Journal of the Office shall be published in the languages of the Office. However, the Executive Director may determine that certain items shall be published in the Official Journal of the Office in the official languages of the Union. 4. The Commission shall adopt implementing acts specifying: (a) the date to be taken as the date of publication in the European Union Trade Marks Bulletin; (b) the manner of publication of entries regarding the registration of a trade mark which do not contain changes as compared to the publication of the application; (c) the forms in which editions of the Official Journal of the Office may be made available to the public. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 117 Administrative cooperation 1. Unless otherwise provided in this Regulation or in national laws, the Office and the courts or authorities of the Member States shall on request give assistance to each other by communicating information or opening files for inspection. Where the Office lays files open to inspection by courts, Public Prosecutors' Offices or central industrial property offices, the inspection shall not be subject to the restrictions laid down in Article 114. 2. The Office shall not charge fees for the communication of information or the opening of files for inspection. 3. The Commission shall adopt implementing acts specifying the detailed arrangements as to how the Office and the authorities of the Member States are to exchange information between each other and open files for inspection, taking into account the restrictions to which the inspection of files relating to EU trade mark applications or registrations is subject, pursuant to Article 114, when it is opened to third parties. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 118 Exchange of publications 1. The Office and the central industrial property offices of the Member States shall despatch to each other on request and for their own use one or more copies of their respective publications free of charge. 2. The Office may conclude agreements relating to the exchange or supply of publications. SECTION 4 Representation Article 119 General principles of representation 1. Subject to the provisions of paragraph 2, no person shall be compelled to be represented before the Office. 2. Without prejudice to the second sentence of paragraph 3 of this Article, natural or legal persons having neither their domicile nor their principal place of business or a real and effective industrial or commercial establishment in the European Economic Area shall be represented before the Office in accordance with Article 120(1) in all proceedings provided for by this Regulation, other than the filing of an application for an EU trade mark. 3. Natural or legal persons having their domicile or principal place of business or a real and effective industrial or commercial establishment in the European Economic Area may be represented before the Office by an employee. An employee of a legal person to which this paragraph applies may also represent other legal persons which have economic connections with the first legal person, even if those other legal persons have neither their domicile nor their principal place of business nor a real and effective industrial or commercial establishment within the European Economic Area. Employees who represent persons, within the meaning of this paragraph, shall, at the request of the Office or, where appropriate, of the party to the proceedings, file with it a signed authorisation for insertion in the files. 4. Where there is more than one applicant or more than one third party acting in common, a common representative shall be appointed. Article 120 Professional representatives 1. Representation of natural or legal persons before the Office may only be undertaken by: (a) a legal practitioner qualified in one of the Member States of the European Economic Area and having his place of business within the European Economic Area, to the extent that he is entitled, within the said Member State, to act as a representative in trade mark matters; (b) professional representatives whose names appear on the list maintained for this purpose by the Office. Representatives acting before the Office shall, at the request of the Office or, where appropriate, of the other party to the proceedings, file with it a signed authorisation for insertion on the files. 2. Any natural person who fulfils the following conditions may be entered on the list of professional representatives: (a) being a national of one of the Member States of the European Economic Area; (b) having his place of business or employment in the European Economic Area; (c) being entitled to represent natural or legal persons in trade mark matters before the Benelux Office for Intellectual Property or before the central industrial property office of a Member State of the European Economic Area. Where, in the State concerned, the entitlement is not conditional upon the requirement of special professional qualifications, persons applying to be entered on the list who act in trade mark matters before the Benelux Office for Intellectual Property or those central industrial property offices shall have habitually so acted for at least five years. However, persons whose professional qualification to represent natural or legal persons in trade mark matters before the Benelux Office for Intellectual Property or those central industrial property offices is officially recognised in accordance with the regulations laid down by the State concerned shall not be required to have exercised the profession. 3. Entry shall be effected upon request, accompanied by a certificate furnished by the central industrial property office of the Member State concerned, indicating that the conditions laid down in paragraph 2 are fulfilled. 4. The Executive Director may grant an exemption from: (a) the requirement in the second sentence of paragraph 2(c), if the applicant furnishes proof that he has acquired the requisite qualification in another way; (b) the requirement set out in paragraph 2(a) in the case of highly qualified professionals, provided that the requirements set out in paragraph 2(b) and (c) are fulfilled. 5. A person may be removed from the list of professional representatives at his request or when no longer in a capacity to represent. The amendments of the list of professional representatives shall be published in the Official Journal of the Office. Article 121 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying: (a) the conditions and the procedure for the appointment of a common representative as referred to in Article 119(4); (b) the conditions under which employees referred to in Article 119(3) and professional representatives referred to in Article 120(1) shall file with the Office a signed authorisation in order to undertake representation, and the content of that authorisation; (c) the circumstances in which a person may be removed from the list of professional representatives referred to in Article 120(5). CHAPTER X JURISDICTION AND PROCEDURE IN LEGAL ACTIONS RELATING TO EU TRADE MARKS SECTION 1 Application of Union rules on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters Article 122 Application of Union rules on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters 1. Unless otherwise specified in this Regulation, the Union rules on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters shall apply to proceedings relating to EU trade marks and applications for EU trade marks, as well as to proceedings relating to simultaneous and successive actions on the basis of EU trade marks and national trade marks. 2. In the case of proceedings in respect of the actions and claims referred to in Article 124: (a) Articles 4 and 6, points 1, 2, 3 and 5 of Article 7 and Article 35 of Regulation (EU) No 1215/2012 shall not apply; (b) Articles 25 and 26 of Regulation (EU) No 1215/2012 shall apply subject to the limitations in Article 125(4) of this Regulation; (c) the provisions of Chapter II of Regulation (EU) No 1215/2012 which are applicable to persons domiciled in a Member State shall also be applicable to persons who do not have a domicile in any Member State but have an establishment therein. 3. References in this Regulation to Regulation (EU) No 1215/2012 shall include, where appropriate, the Agreement between the European Community and the Kingdom of Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters done on 19 October 2005. SECTION 2 Disputes concerning the infringement and validity of EU trade marks Article 123 EU trade mark courts 1. The Member States shall designate in their territories as limited a number as possible of national courts and tribunals of first and second instance, which shall perform the functions assigned to them by this Regulation. 2. Any change made in the number, names or territorial jurisdiction of the courts included in the list of EU trade mark courts communicated by a Member State to the Commission in accordance with Article 95(2) of Regulation (EC) No 207/2009 shall be notified without delay by the Member State concerned to the Commission. 3. The information referred to in paragraph 2 shall be notified by the Commission to the Member States and published in the Official Journal of the European Union. Article 124 Jurisdiction over infringement and validity The EU trade mark courts shall have exclusive jurisdiction: (a) for all infringement actions and \u2014 if they are permitted under national law \u2014 actions in respect of threatened infringement relating to EU trade marks; (b) for actions for declaration of non-infringement, if they are permitted under national law; (c) for all actions brought as a result of acts referred to in Article 11(2); (d) for counterclaims for revocation or for a declaration of invalidity of the EU trade mark pursuant to Article 128. Article 125 International jurisdiction 1. Subject to the provisions of this Regulation as well as to any provisions of Regulation (EU) No 1215/2012 applicable by virtue of Article 122, proceedings in respect of the actions and claims referred to in Article 124 shall be brought in the courts of the Member State in which the defendant is domiciled or, if he is not domiciled in any of the Member States, in which he has an establishment. 2. If the defendant is neither domiciled nor has an establishment in any of the Member States, such proceedings shall be brought in the courts of the Member State in which the plaintiff is domiciled or, if he is not domiciled in any of the Member States, in which he has an establishment. 3. If neither the defendant nor the plaintiff is so domiciled or has such an establishment, such proceedings shall be brought in the courts of the Member State where the Office has its seat. 4. Notwithstanding the provisions of paragraphs 1, 2 and 3: (a) Article 25 of Regulation (EU) No 1215/2012 shall apply if the parties agree that a different EU trade mark court shall have jurisdiction; (b) Article 26 of Regulation (EU) No 1215/2012 shall apply if the defendant enters an appearance before a different EU trade mark court. 5. Proceedings in respect of the actions and claims referred to in Article 124, with the exception of actions for a declaration of non-infringement of an EU trade mark, may also be brought in the courts of the Member State in which the act of infringement has been committed or threatened, or in which an act referred to in Article 11(2) has been committed. Article 126 Extent of jurisdiction 1. An EU trade mark court whose jurisdiction is based on Article 125(1) to (4) shall have jurisdiction in respect of: (a) acts of infringement committed or threatened within the territory of any of the Member States; (b) acts referred to in Article 11(2) committed within the territory of any of the Member States. 2. An EU trade mark court whose jurisdiction is based on Article 125(5) shall have jurisdiction only in respect of acts committed or threatened within the territory of the Member State in which that court is situated. Article 127 Presumption of validity \u2014 Defence as to the merits 1. The EU trade mark courts shall treat the EU trade mark as valid unless its validity is put in issue by the defendant with a counterclaim for revocation or for a declaration of invalidity. 2. The validity of an EU trade mark may not be put in issue in an action for a declaration of non-infringement. 3. In the actions referred to in points (a) and (c) of Article 124, a plea relating to revocation of the EU trade mark submitted otherwise than by way of a counterclaim shall be admissible where the defendant claims that the EU trade mark could be revoked for lack of genuine use at the time the infringement action was brought. Article 128 Counterclaims 1. A counterclaim for revocation or for a declaration of invalidity may only be based on the grounds for revocation or invalidity mentioned in this Regulation. 2. An EU trade mark court shall reject a counterclaim for revocation or for a declaration of invalidity if a decision taken by the Office relating to the same subject matter and cause of action and involving the same parties has already become final. 3. If the counterclaim is brought in a legal action to which the proprietor of the trade mark is not already a party, he shall be informed thereof and may be joined as a party to the action in accordance with the conditions set out in national law. 4. The EU trade mark court with which a counterclaim for revocation or for a declaration of invalidity of the EU trade mark has been filed shall not proceed with the examination of the counterclaim, until either the interested party or the court has informed the Office of the date on which the counterclaim was filed. The Office shall record that information in the Register. If an application for revocation or for a declaration of invalidity of the EU trade mark had already been filed before the Office before the counterclaim was filed, the court shall be informed thereof by the Office and stay the proceedings in accordance with Article 132(1) until the decision on the application is final or the application is withdrawn. 5. Article 64(2) to (5) shall apply. 6. Where an EU trade mark court has given a judgment which has become final on a counterclaim for revocation or for a declaration of invalidity of an EU trade mark, a copy of the judgment shall be sent to the Office without delay, either by the court or by any of the parties to the national proceedings. The Office or any other interested party may request information about such transmission. The Office shall mention the judgment in the Register and shall take the necessary measures to comply with its operative part. 7. The EU trade mark court hearing a counterclaim for revocation or for a declaration of invalidity may stay the proceedings on application by the proprietor of the EU trade mark and after hearing the other parties and may request the defendant to submit an application for revocation or for a declaration of invalidity to the Office within a time limit which it shall determine. If the application is not made within the time limit, the proceedings shall continue; the counterclaim shall be deemed withdrawn. Article 132(3) shall apply. Article 129 Applicable law 1. The EU trade mark courts shall apply the provisions of this Regulation. 2. On all trade mark matters not covered by this Regulation, the relevant EU trade mark court shall apply the applicable national law. 3. Unless otherwise provided for in this Regulation, an EU trade mark court shall apply the rules of procedure governing the same type of action relating to a national trade mark in the Member State in which the court is located. Article 130 Sanctions 1. Where an EU trade mark court finds that the defendant has infringed or threatened to infringe an EU trade mark, it shall, unless there are special reasons for not doing so, issue an order prohibiting the defendant from proceeding with the acts which infringed or would infringe the EU trade mark. It shall also take such measures in accordance with its national law as are aimed at ensuring that this prohibition is complied with. 2. The EU trade mark court may also apply measures or orders available under the applicable law which it deems appropriate in the circumstances of the case. Article 131 Provisional and protective measures 1. Application may be made to the courts of a Member State, including EU trade mark courts, for such provisional, including protective, measures in respect of an EU trade mark or EU trade mark application as may be available under the law of that State in respect of a national trade mark, even if, under this Regulation, an EU trade mark court of another Member State has jurisdiction as to the substance of the matter. 2. An EU trade mark court whose jurisdiction is based on Article 125(1), (2), (3) or (4) shall have jurisdiction to grant provisional and protective measures which, subject to any necessary procedure for recognition and enforcement pursuant to Chapter III of Regulation (EU) No 1215/2012, are applicable in the territory of any Member State. No other court shall have such jurisdiction. Article 132 Specific rules on related actions 1. An EU trade mark court hearing an action referred to in Article 124 other than an action for a declaration of non-infringement shall, unless there are special grounds for continuing the hearing, of its own motion after hearing the parties or at the request of one of the parties and after hearing the other parties, stay the proceedings where the validity of the EU trade mark is already in issue before another EU trade mark court on account of a counterclaim or where an application for revocation or for a declaration of invalidity has already been filed at the Office. 2. The Office, when hearing an application for revocation or for a declaration of invalidity shall, unless there are special grounds for continuing the hearing, of its own motion after hearing the parties or at the request of one of the parties and after hearing the other parties, stay the proceedings where the validity of the EU trade mark is already in issue on account of a counterclaim before an EU trade mark court. However, if one of the parties to the proceedings before the EU trade mark court so requests, the court may, after hearing the other parties to these proceedings, stay the proceedings. The Office shall in this instance continue the proceedings pending before it. 3. Where the EU trade mark court stays the proceedings it may order provisional and protective measures for the duration of the stay. Article 133 Jurisdiction of EU trade mark courts of second instance \u2014 Further appeal 1. An appeal to the EU trade mark courts of second instance shall lie from judgments of the EU trade mark courts of first instance in respect of proceedings arising from the actions and claims referred to in Article 124. 2. The conditions under which an appeal may be lodged with an EU trade mark court of second instance shall be determined by the national law of the Member State in which that court is located. 3. The national rules concerning further appeal shall be applicable in respect of judgments of EU trade mark courts of second instance. SECTION 3 Other disputes concerning EU trade marks Article 134 Supplementary provisions on the jurisdiction of national courts other than EU trade mark courts 1. Within the Member State whose courts have jurisdiction under Article 122(1) those courts shall have jurisdiction for actions other than those referred to in Article 124, which would have jurisdiction ratione loci and ratione materiae in the case of actions relating to a national trade mark registered in that State. 2. Actions relating to an EU trade mark, other than those referred to in Article 124, for which no court has jurisdiction under Article 122(1) and paragraph 1 of this Article may be heard before the courts of the Member State in which the Office has its seat. Article 135 Obligation of the national court A national court which is dealing with an action relating to an EU trade mark, other than the action referred to in Article 124, shall treat the EU trade mark as valid. CHAPTER XI EFFECTS ON THE LAWS OF THE MEMBER STATES SECTION 1 Civil actions on the basis of more than one trade mark Article 136 Simultaneous and successive civil actions on the basis of EU trade marks and national trade marks 1. Where actions for infringement involving the same cause of action and between the same parties are brought in the courts of different Member States, one seised on the basis of an EU trade mark and the other seised on the basis of a national trade mark: (a) the court other than the court first seised shall of its own motion decline jurisdiction in favour of that court where the trade marks concerned are identical and valid for identical goods or services. The court which would be required to decline jurisdiction may stay its proceedings if the jurisdiction of the other court is contested; (b) the court other than the court first seised may stay its proceedings where the trade marks concerned are identical and valid for similar goods or services and where the trade marks concerned are similar and valid for identical or similar goods or services. 2. The court hearing an action for infringement on the basis of an EU trade mark shall reject the action if a final judgment on the merits has been given on the same cause of action and between the same parties on the basis of an identical national trade mark valid for identical goods or services. 3. The court hearing an action for infringement on the basis of a national trade mark shall reject the action if a final judgment on the merits has been given on the same cause of action and between the same parties on the basis of an identical EU trade mark valid for identical goods or services. 4. Paragraphs 1, 2 and 3 shall not apply in respect of provisional, including protective, measures. SECTION 2 Application of national laws for the purpose of prohibiting the use of EU trade marks Article 137 Prohibition of use of EU trade marks 1. This Regulation shall, unless otherwise provided for, not affect the right existing under the laws of the Member States to invoke claims for infringement of earlier rights within the meaning of Article 8 or Article 60(2) in relation to the use of a later EU trade mark. Claims for infringement of earlier rights within the meaning of Article 8(2) and (4) may, however, no longer be invoked if the proprietor of the earlier right may no longer apply for a declaration that the EU trade mark is invalid in accordance with Article 61(2). 2. This Regulation shall, unless otherwise provided for, not affect the right to bring proceedings under the civil, administrative or criminal law of a Member State or under provisions of Union law for the purpose of prohibiting the use of an EU trade mark to the extent that the use of a national trade mark may be prohibited under the law of that Member State or under Union law. Article 138 Prior rights applicable to particular localities 1. The proprietor of an earlier right which only applies to a particular locality may oppose the use of the EU trade mark in the territory where his right is protected in so far as the law of the Member State concerned so permits. 2. Paragraph 1 shall cease to apply if the proprietor of the earlier right has acquiesced in the use of the EU trade mark in the territory where his right is protected for a period of five successive years, being aware of such use, unless the EU trade mark was applied for in bad faith. 3. The proprietor of the EU trade mark shall not be entitled to oppose use of the right referred to in paragraph 1 even though that right may no longer be invoked against the EU trade mark. SECTION 3 Conversion into a national trade mark application Article 139 Request for the application of national procedure 1. The applicant for or proprietor of an EU trade mark may request the conversion of his EU trade mark application or EU trade mark into a national trade mark application: (a) to the extent that the EU trade mark application is refused, withdrawn, or deemed to be withdrawn; (b) to the extent that the EU trade mark ceases to have effect. 2. Conversion shall not take place: (a) where the rights of the proprietor of the EU trade mark have been revoked on the grounds of non-use, unless in the Member State for which conversion is requested the EU trade mark has been put to use which would be considered to be genuine use under the laws of that Member State; (b) for the purpose of protection in a Member State in which, in accordance with the decision of the Office or of the national court, grounds for refusal of registration or grounds for revocation or invalidity apply to the EU trade mark application or EU trade mark. 3. The national trade mark application resulting from the conversion of an EU trade mark application or an EU trade mark shall enjoy in respect of the Member State concerned the date of filing or the date of priority of that application or trade mark and, where appropriate, the seniority of a trade mark of that State claimed under Articles 39 or 40. 4. In cases where an EU trade mark application is deemed to be withdrawn, the Office shall send to the applicant a communication fixing a period of three months from the date of that communication in which a request for conversion may be filed. 5. Where the EU trade mark application is withdrawn or the EU trade mark ceases to have effect as a result of a surrender being recorded or of failure to renew the registration, the request for conversion shall be filed within three months of the date on which the EU trade mark application has been withdrawn or on which the EU trade mark ceases to have effect. 6. Where the EU trade mark application is refused by decision of the Office or where the EU trade mark ceases to have effect as a result of a decision of the Office or of an EU trade mark court, the request for conversion shall be filed within three months of the date on which that decision acquired the authority of a final decision. 7. The effect referred to in Article 37 shall lapse if the request is not filed in due time. Article 140 Submission, publication and transmission of the request for conversion 1. A request for conversion shall be filed with the Office within the relevant period pursuant to Article 139(4), (5) or (6), and shall include an indication of the grounds for conversion in accordance with Article 139(1)(a) or (b), the Member States in respect of which conversion is requested, and the goods and services subject to conversion. Where conversion is requested following a failure to renew the registration, the period of three months provided for in Article 139(5) shall begin to run on the day following the last day on which the request for renewal can be presented pursuant to Article 53(3). The request for conversion shall not be deemed to be filed until the conversion fee has been paid. 2. Where the request for conversion relates to an EU trade mark application which has already been published or where the request for conversion relates to an EU trade mark, receipt of any such request shall be recorded in the Register and the request for conversion shall be published. 3. The Office shall check whether the conversion requested fulfils the conditions set out in this Regulation, in particular Article 139(1), (2), (4), (5) and (6), and paragraph 1 of this Article, together with the formal conditions specified in the implementing act adopted pursuant to paragraph 6 of this Article. If the conditions governing the request are not fulfilled, the Office shall notify the applicant of the deficiencies. If the deficiencies are not remedied within a period to be specified by the Office, the Office shall reject the request for conversion. Where Article 139(2) applies, the Office shall reject the request for conversion as inadmissible only with respect to those Member States for which conversion is excluded under that provision. Where the conversion fee has not been paid within the relevant period of three months pursuant to Article 139(4), (5) or (6), the Office shall inform the applicant that the request for conversion is deemed not to have been filed. 4. If the Office or an EU trade mark court has refused the EU trade mark application or has declared the EU trade mark invalid on absolute grounds by reference to the language of a Member State, conversion shall be excluded under Article 139(2) for all the Member States in which that language is one of the official languages. If the Office or an EU trade mark court has refused the EU trade mark application or has declared the EU trade mark invalid on absolute grounds which are found to apply throughout the Union or on account of an earlier EU trade mark or other Union industrial property right, conversion shall be excluded under Article 139(2) for all Member States. 5. Where the request for conversion complies with the requirements referred to in paragraph 3 of this Article, the Office shall transmit the request for conversion and the data referred to in Article 111(2) to the central industrial property offices of the Member States, including the Benelux Office for Intellectual Property, for which the request has been found admissible. The Office shall inform the applicant of the date of transmission. 6. The Commission shall adopt implementing acts specifying: (a) the details to be contained in a request for conversion of an EU trade mark application or a registered EU trade mark into a national trade mark application pursuant to paragraph 1; (b) the details which are to be contained in the publication of the request for conversion pursuant to paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 141 Formal requirements for conversion 1. Any central industrial property office to which the request for conversion is transmitted may obtain from the Office any additional information concerning the request enabling that office to make a decision regarding the national trade mark resulting from the conversion. 2. An EU trade mark application or an EU trade mark transmitted in accordance with Article 140 shall not be subject to formal requirements of national law which are different from or additional to those provided for in this Regulation or in acts adopted pursuant to this Regulation. 3. Any central industrial property office to which the request is transmitted may require that the applicant shall, within not less than two months: (a) pay the national application fee; (b) file a translation in one of the official languages of the State in question of the request and of the documents accompanying it; (c) indicate an address for service in the State in question; (d) supply a representation of the trade mark in the number of copies specified by the State in question. CHAPTER XII THE OFFICE SECTION 1 General provisions Article 142 Legal status 1. The Office shall be an agency of the Union. It shall have legal personality. 2. In each of the Member States the Office shall enjoy the most extensive legal capacity accorded to legal persons under their laws; it may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings. 3. The Office shall be represented by its Executive Director. Article 143 Staff 1. The Staff Regulations, the Conditions of Employment and the rules adopted by agreement between the institutions of the Union for giving effect to those Staff Regulations and Conditions of Employment shall apply to the staff of the Office, without prejudice to the application of Article 166 of this Regulation to the members of the Boards of Appeal. 2. Without prejudice to paragraph 1, the Office may make use of seconded national experts or other staff not employed by the Office. The Management Board shall adopt a decision laying down rules on the secondment to the Office of national experts. Article 144 Privileges and immunities The Protocol on the Privileges and Immunities of the Union shall apply to the Office and its staff. Article 145 Liability 1. The contractual liability of the Office shall be governed by the law applicable to the contract in question. 2. The Court of Justice shall be competent to give judgment pursuant to any arbitration clause contained in a contract concluded by the Office. 3. In the case of non-contractual liability, the Office shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its departments or by its servants in the performance of their duties. 4. The Court of Justice shall have jurisdiction in disputes relating to compensation for the damage referred to in paragraph 3. 5. The personal liability of its servants towards the Office shall be governed by the provisions laid down in the Staff Regulations or in the Conditions of Employment applicable to them. Article 146 Languages 1. The application for an EU trade mark shall be filed in one of the official languages of the Union. 2. The languages of the Office shall be English, French, German, Italian and Spanish. 3. The applicant shall indicate a second language which shall be a language of the Office the use of which he accepts as a possible language of proceedings for opposition, revocation or invalidity proceedings. If the application was filed in a language which is not one of the languages of the Office, the Office shall arrange to have the application, as described in Article 31(1), translated into the language indicated by the applicant. 4. Where the applicant for an EU trade mark is the sole party to proceedings before the Office, the language of proceedings shall be the language used for filing the application for an EU trade mark. If the application was made in a language other than the languages of the Office, the Office may send written communications to the applicant in the second language indicated by the applicant in his application. 5. The notice of opposition and an application for revocation or a declaration of invalidity shall be filed in one of the languages of the Office. 6. Without prejudice to paragraph 5: (a) any application or declaration relating to an EU trade mark application may be filed in the language used for filing the application for that EU trade mark or in the second language indicated by the applicant in his application; (b) any application or declaration relating to a registered EU trade mark may be filed in one of the languages of the Office. However, when the application is filed by using any form provided by the Office as referred to in Article 100(2), such forms may be used in any of the official languages of the Union, provided that the form is completed in one of the languages of the Office, as far as textual elements are concerned. 7. If the language chosen, in accordance with paragraph 5, for the notice of opposition or the application for revocation or invalidity is the language of the application for a trade mark or the second language indicated when the application was filed, that language shall be the language of the proceedings. If the language chosen, in accordance with paragraph 5, for the notice of opposition or the application for revocation or invalidity is neither the language of the application for a trade mark nor the second language indicated when the application was filed, the opposing party or the party seeking revocation or invalidity shall be required to produce, at his own expense, a translation of his application either into the language of the application for a trade mark, provided that it is a language of the Office, or into the second language indicated when the application was filed. The translation shall be produced within one month of the expiry of the opposition period or of the date of filing an application for revocation or a declaration of invalidity. The language into which the application has been translated shall then become the language of the proceedings. 8. Parties to opposition, revocation, invalidity or appeal proceedings may agree that a different official language of the Union is to be the language of the proceedings. 9. Without prejudice to paragraphs 4 and 8, and unless provided otherwise, in written proceedings before the Office any party may use any language of the Office. If the language chosen is not the language of the proceedings, the party shall supply a translation into that language within one month of the date of the submission of the original document. Where the applicant for an EU trade mark is the sole party to proceedings before the Office and the language used for the filing of the application for the EU trade mark is not one of the languages of the Office, the translation may also be filed in the second language indicated by the applicant in his application. 10. The Executive Director shall determine the manner in which translations are to be certified. 11. The Commission shall adopt implementing acts specifying: (a) the extent to which supporting documents to be used in written proceedings before the Office may be filed in any language of the Union, and the need to supply a translation; (b) the requisite standards of translations to be filed with the Office. Those implementing acts shall be adopted in accordance with the examination procedure referred to Article 207(2). Article 147 Publication and entries in the Register 1. An application for an EU trade mark, as described in Article 31(1), and all other information the publication of which is prescribed by this Regulation or an act adopted pursuant to this Regulation, shall be published in all the official languages of the Union. 2. All entries in the Register shall be made in all the official languages of the Union. 3. In cases of doubt, the text in the language of the Office in which the application for the EU trade mark was filed shall be authentic. If the application was filed in an official language of the Union other than one of the languages of the Office, the text in the second language indicated by the applicant shall be authentic. Article 148 Translation services The translation services required for the functioning of the Office shall be provided by the Translation Centre for the Bodies of the European Union. Article 149 Transparency 1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council (16) shall apply to documents held by the Office. 2. The Management Board shall adopt detailed rules for applying Regulation (EC) No 1049/2001. 3. Decisions taken by the Office under Article 8 of Regulation (EC) No 1049/2001 may be challenged through the European Ombudsman or form the subject of an action before the Court of Justice of the European Union, under the conditions laid down in Articles 228 and 263 TFEU respectively. 4. The processing of personal data by the Office shall be subject to Regulation (EC) No 45/2001 of the European Parliament and of the Council (17). Article 150 Security rules on the protection of classified and sensitive non-classified information The Office shall apply the security principles contained in the Commission's security rules for protecting European Union Classified Information (EUCI) and sensitive non-classified information, as set out in Commission Decisions (EU, Euratom) 2015/443 (18) and 2015/444 (19). The security principles shall cover, inter alia, provisions for the exchange, processing and storage of such information. SECTION 2 Tasks of the office and cooperation to promote convergence Article 151 Tasks of the Office 1. The Office shall have the following tasks: (a) administration and promotion of the EU trade mark system established in this Regulation; (b) administration and promotion of the European Union design system established in Council Regulation (EC) No 6/2002 (20); (c) promoting convergence of practices and tools in the fields of trade marks and designs, in cooperation with the central industrial property offices in the Member States, including the Benelux Office for Intellectual Property; (d) the tasks referred to in Regulation (EU) No 386/2012 of the European Parliament and of the Council (21); (e) the tasks conferred on it under Directive 2012/28/EU of the European Parliament and of the Council (22). 2. The Office shall cooperate with institutions, authorities, bodies, industrial property offices, international and non-governmental organisations in relation to the tasks conferred on it in paragraph 1. 3. The Office may provide voluntary mediation services for the purpose of assisting parties in reaching a friendly settlement. Article 152 Cooperation to promote convergence of practices and tools 1. The Office and the central industrial property offices of the Member States and the Benelux Office for Intellectual Property shall cooperate with each other to promote convergence of practices and tools in the field of trade marks and designs. Without prejudice to paragraph 3, this cooperation shall in particular cover the following areas of activity: (a) the development of common examination standards; (b) the creation of common or connected databases and portals for Union-wide consultation, search and classification purposes; (c) the continuous provision and exchange of data and information, including for the purposes of feeding of the databases and portals referred to in point (b); (d) the establishment of common standards and practices, with a view to ensuring interoperability between procedures and systems throughout the Union and enhancing their consistency, efficiency and effectiveness; (e) the sharing of information on industrial property rights and procedures, including mutual support to helpdesks and information centres; (f) the exchange of technical expertise and assistance in relation to the areas referred to in points (a) to (e). 2. On the basis of a proposal by the Executive Director, the Management Board shall define and coordinate projects of interest to the Union and the Member States with regard to the areas referred to in paragraphs 1 and 6, and shall invite the central industrial property offices of the Member States and the Benelux Office for Intellectual Property to participate in those projects. The project definition shall contain the specific obligations and responsibilities of each participating industrial property office of the Member States, the Benelux Office for Intellectual Property and the Office. The Office shall consult with user representatives in particular in the phases of definition of the projects and evaluation of their results. 3. The central industrial property offices of the Member States and the Benelux Office for Intellectual Property may opt out of, restrict or temporarily suspend their cooperation in the projects referred to in the first subparagraph of paragraph 2. When making use of the possibilities provided for in the first subparagraph, the central industrial property offices of the Member States and the Benelux Office for Intellectual Property shall provide the Office with a written statement explaining the reasons for their decision. 4. Once having committed to participate in certain projects, the central industrial property offices of the Member States and the Benelux Office for Intellectual Property shall, without prejudice to paragraph 3, participate effectively in the projects referred to in paragraph 2 with a view to ensuring that they are developed, function, are interoperable and kept up to date. 5. The Office shall provide financial support to the projects referred to in paragraph 2 to the extent that is necessary in order to ensure, for the purposes of paragraph 4, the effective participation of the central industrial property offices of the Member States and the Benelux Office for Intellectual Property in those projects. That financial support may take the form of grants and in-kind contributions. The total amount of funding shall not exceed 15 % of the yearly revenue of the Office. The beneficiaries of grants shall be the central industrial property offices of the Member States and the Benelux Office for Intellectual Property. Grants may be awarded without calls for proposals in accordance with the financial rules applicable to the Office and with the principles of grant procedures contained in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (23) and in Commission Delegated Regulation (EU) No 1268/2012 (24). 6. The Office and the relevant competent authorities of the Member States shall cooperate with each other on a voluntary basis to promote the raising of awareness concerning the trade mark system and the fight against counterfeiting. Such cooperation shall include projects aiming, in particular, at the implementation of established standards and practices as well as at organising education and training activities. The financial support for those projects shall be part of the total amount of funding referred to in paragraph 5. Paragraphs 2 to 5 shall apply mutatis mutandis. SECTION 3 Management Board Article 153 Functions of the Management Board 1. Without prejudice to the functions attributed to the Budget Committee in Section 6, the Management Board shall have the following functions: (a) on the basis of a draft submitted by the Executive Director in accordance with Article 157(4)(c), adopting the annual work programme of the Office for the coming year, taking into account the opinion of the Commission, and forwarding the adopted annual work programme to the European Parliament, to the Council and to the Commission; (b) on the basis of a draft submitted by the Executive Director in accordance with Article 157(4)(e) and taking into account the opinion of the Commission, adopting a multiannual strategic programme for the Office, including the Office's strategy for international cooperation, following an exchange of views between the Executive Director and the relevant committee in the European Parliament, and forwarding the adopted multiannual strategic programme to the European Parliament, to the Council and to the Commission; (c) on the basis of a draft submitted by the Executive Director in accordance with Article 157(4)(g), adopting the annual report and forwarding the adopted annual report to the European Parliament, to the Council, to the Commission and to the Court of Auditors; (d) on the basis of a draft submitted by the Executive Director in accordance with Article 157(4)(h), adopting the multiannual staff policy plan; (e) exercising the powers conferred on it under Article 152(2); (f) exercising the powers conferred on it under Article 172(5); (g) adopting rules on the prevention and management of conflicts of interest in the Office; (h) in accordance with paragraph 2, exercising, with respect to the staff of the Office, the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment on the Authority Empowered to Conclude Contracts of Employment (\u2018the appointing authority powers\u2019); (i) adopting appropriate implementing rules to give effect to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations; (j) drawing up the list of candidates provided for in Article 158(2); (k) ensuring adequate follow-up to the findings and recommendations stemming from the internal or external audit reports and evaluations referred to in Article 210, as well as from investigations of the European Anti-fraud Office (OLAF); (l) being consulted before adoption of the guidelines for examination in the Office and in the other cases provided for in this Regulation; (m) providing opinions and requests for information to the Executive Director and to the Commission where it considers it necessary. 2. The Management Board shall adopt, in accordance with Article 110 of the Staff Regulations and Article 142 of the Conditions of Employment, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment, delegating the relevant appointing authority powers to the Executive Director and defining the conditions under which that delegation of appointing authority powers can be suspended. The Executive Director shall be authorised to sub-delegate those powers. Where exceptional circumstances so require, the Management Board may, by way of a decision, temporarily suspend the delegation of the appointing authority powers to the Executive Director and those sub-delegated by the latter, and exercise them itself or delegate them to one of its members or to a staff member other than the Executive Director. Article 154 Composition of the Management Board 1. The Management Board shall be composed of one representative of each Member State, two representatives of the Commission and one representative of the European Parliament, and their respective alternates. 2. The members of the Management Board may, subject to its rules of procedure, be assisted by advisers or experts. Article 155 Chairperson of the Management Board 1. The Management Board shall elect a chairperson and a deputy chairperson from among its members. The deputy chairperson shall ex officio replace the chairperson in the event of his being prevented from attending to his duties. 2. The duration of the terms of office of the chairperson and the deputy chairperson shall be four years. The terms of office shall be renewable once. If, however, their membership of the Management Board ends at any time during their term of office, their term of office shall automatically expire on that date also. Article 156 Meetings 1. Meetings of the Management Board shall be convened by its chairperson. 2. The Executive Director shall take part in the deliberations, unless the Management Board decides otherwise. 3. The Management Board shall hold an ordinary meeting at least once a year. In addition, it shall meet on the initiative of its chairperson or at the request of the Commission or of one-third of the Member States. 4. The Management Board shall adopt rules of procedure. 5. The Management Board shall take its decisions by an absolute majority of its members. However, a majority of two-thirds of its members shall be required for the decisions which the Management Board is empowered to take under Article 153(1)(a) and (b), Article 155(1) and Article 158(2) and (4). In both cases each member shall have one vote. 6. The Management Board may invite observers to attend its meetings. 7. The secretariat for the Management Board shall be provided by the Office. SECTION 4 Executive Director Article 157 Functions of the Executive Director 1. The Office shall be managed by the Executive Director. The Executive Director shall be accountable to the Management Board. 2. Without prejudice to the powers of the Commission, the Management Board, and the Budget Committee, the Executive Director shall be independent in the performance of his duties and shall neither seek nor take instructions from a government or from any other body. 3. The Executive Director shall be the legal representative of the Office. 4. The Executive Director shall have in particular the following functions, which may be delegated: (a) taking all necessary steps, including the adoption of internal administrative instructions and the publication of notices, to ensure the functioning of the Office; (b) implementing the decisions adopted by the Management Board; (c) preparing a draft annual work programme indicating estimated human and financial resources for each activity, and submitting it to the Management Board after consultation of the Commission; (d) submitting to the Management Board proposals pursuant to Article 152(2); (e) preparing a draft multiannual strategic programme, including the Office's strategy for international cooperation, and submitting it to the Management Board after consultation of the Commission and following an exchange of views with the relevant committee in the European Parliament; (f) implementing the annual work programme and the multiannual strategic programme and reporting to the Management Board on their implementation; (g) preparing the annual report on the Office's activities and presenting it to the Management Board for approval; (h) preparing a draft multiannual staff policy plan and submitting it to the Management Board after consultation of the Commission; (i) preparing an action plan following-up on the conclusions of the internal or external audit reports and evaluations, as well as following up on the investigations of the OLAF, and reporting on progress twice a year to the Commission and to the Management Board; (j) protecting the financial interests of the Union by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by imposing effective, proportionate and dissuasive administrative and financial penalties; (k) preparing an anti-fraud strategy for the Office and presenting it to the Budget Committee for approval; (l) in order to ensure uniform application of the Regulation, referring, where appropriate, to the enlarged Board of Appeal (\u2018the Grand Board\u2019) questions on a point of law, in particular if the Boards of Appeal have issued diverging decisions on the point; (m) drawing up estimates of the revenue and expenditure of the Office and implementing the budget; (n) exercising the powers entrusted to him in respect of staff by the Management Board under Article 153(1)(h); (o) exercising the powers conferred on him under Articles 31(3), 34(5), 35(3), 94(2), 97(5), Articles 98, 100, 101, Articles 111(4), 112(3), 114(5), Articles 115, 116, Articles 120(4), 146(10), Article 178, Articles 179(1) and 180(2), and Article 181 in accordance with the criteria set out in this Regulation and in the acts adopted pursuant to this Regulation. 5. The Executive Director shall be assisted by one or more Deputy Executive Directors. If the Executive Director is absent or indisposed, the Deputy Executive Director or one of the Deputy Executive Directors shall replace him in accordance with the procedure laid down by the Management Board. Article 158 Appointment and removal of the Executive Director and extension of term of office 1. The Executive Director shall be engaged as a temporary agent of the Office under Article 2(a) of the Conditions of Employment. 2. The Executive Director shall be appointed by the Council by simple majority, from a list of candidates proposed by the Management Board, following an open and transparent selection procedure. Before being appointed, the candidate selected by the Management Board may be invited to make a statement before any competent European Parliament committee and to answer questions put by its members. For the purpose of concluding the contract with the Executive Director, the Office shall be represented by the chairperson of the Management Board. The Executive Director may be removed from office only upon a decision of the Council acting on a proposal from the Management Board. 3. The term of office of the Executive Director shall be five years. By the end of that period, the Management Board shall undertake an assessment which takes into account an evaluation of the performance of the Executive Director and the Office's future tasks and challenges. 4. The Council, taking into account the assessment referred to in paragraph 3, may extend the term of office of the Executive Director once and for no more than five years. 5. An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of his overall term of office. 6. The Deputy Executive Director or Deputy Executive Directors shall be appointed or removed from office as provided for in paragraph 2, after consultation of the Executive Director and, where applicable, the Executive Director-elect. The term of office of the Deputy Executive Director shall be five years. It may be extended once and for no more than five years by the Council, after consultation of the Executive Director. SECTION 5 Implementation of procedures Article 159 Competence For taking decisions in connection with the procedures laid down in this Regulation, the following shall be competent: (a) examiners; (b) Opposition Divisions; (c) a department in charge of the Register; (d) Cancellation Divisions; (e) Boards of Appeal; (f) any other unit or person appointed by the Executive Director to that effect. Article 160 Examiners An examiner shall be responsible for taking decisions on behalf of the Office in relation to an application for registration of an EU trade mark, including the matters referred to in Articles 41, 42, 76 and 85, except in so far as an Opposition Division is responsible. Article 161 Opposition Divisions 1. An Opposition Division shall be responsible for taking decisions on an opposition to an application to register an EU trade mark. 2. The decisions of the Opposition Divisions shall be taken by three-member groups. At least one member shall be legally qualified. Decisions relating to costs or to procedures shall be taken by a single member. The Commission shall adopt implementing acts specifying the exact types of decisions that are to be taken by a single member. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 162 Department in charge of the Register 1. The Department in charge of the Register shall be responsible for taking decisions in respect of entries in the Register. 2. It shall also be responsible for keeping the list of professional representatives referred to in Article 120(2). 3. The decisions of the Department shall be taken by a single member. Article 163 Cancellation Divisions 1. A Cancellation Division shall be responsible for taking decisions in relation to: (a) applications for the revocation or a declaration of invalidity of an EU trade mark; (b) requests for the assignment of an EU trade mark as provided for in Article 21. 2. The decisions of the Cancellation Divisions shall be taken by three-member groups. At least one member shall be legally qualified. Decisions relating to costs or to procedures as specified in the acts adopted pursuant to Article 161(2) shall be taken by a single member. Article 164 General Competence Decisions required under this Regulation which do not fall within the competence of an examiner, an Opposition Division, a Cancellation Division or the Department in charge of the Register, shall be taken by any official or unit appointed by the Executive Director for that purpose. Article 165 Boards of Appeal 1. The Boards of Appeal shall be responsible for deciding on appeals from decisions taken pursuant to Articles 160 to 164. 2. The decisions of the Boards of Appeal shall be taken by three members, at least two of whom are legally qualified. In certain specific cases, decisions shall be taken by the Grand Board chaired by the President of the Boards of Appeal or by a single member, who shall be legally qualified. 3. In order to determine the special cases which fall under the jurisdiction of the Grand Board, account should be taken of the legal difficulty or the importance of the case or of special circumstances which justify it. Such cases may be referred to the Grand Board: (a) by the authority of the Boards of Appeal referred to in Article 166(4)(a); or (b) by the Board handling the case. 4. The Grand Board shall also be responsible for giving reasoned opinions on questions of law referred to it by the Executive Director pursuant to Article 157(4)(l). 5. To determine which specific cases fall under the authority of a single member, account should be taken of the lack of difficulty of the legal or factual matters raised, the limited importance of the individual case or the absence of other specific circumstances. The decision to confer a case on one member in the cases referred to shall be adopted by the Board handling the case. Article 166 Independence of the members of the Boards of Appeal 1. The President of the Boards of Appeal and the chairpersons of the Boards shall be appointed, in accordance with the procedure laid down in Article 158 for the appointment of the Executive Director, for a term of five years. They shall not be removed from office during this term, unless there are serious grounds for such removal and the Court of Justice, on application by the institution which appointed them, takes a decision to this effect. 2. The term of office of the President of the Boards of Appeal may be extended once for one additional five-year period, or until retirement age if this age is reached during the new term of office, after a prior positive evaluation of his performance by the Management Board. 3. The term of office of the chairpersons of the Boards may be extended for additional five-year periods, or until retirement age if this age is reached during the new term of office, after a prior positive evaluation of their performance by the Management Board, and after consulting the President of the Boards of Appeal. 4. The President of the Boards of Appeal shall have the following managerial and organisational functions: (a) chairing the Presidium of the Boards of Appeal (\u2018the Presidium\u2019), responsible for laying down the rules and organising the work of the Boards; (b) ensuring the implementation of the decisions of the Presidium; (c) allocating cases to a Board on the basis of objective criteria determined by the Presidium; (d) forwarding to the Executive Director the Boards' expenditure requirements, with a view to drawing up the expenditure estimates. The President of the Boards of Appeal shall chair the Grand Board. 5. The members of the Boards of Appeal shall be appointed by the Management Board for a term of five years. Their term of office may be extended for additional five-year periods, or until retirement age if that age is reached during the new term of office after a prior positive evaluation of their performance by the Management Board, and after consulting the President of the Boards of Appeal. 6. The members of the Boards of Appeal shall not be removed from office unless there are serious grounds for such removal and the Court of Justice, after the case has been referred to it by the Management Board on the recommendation of the President of the Boards of Appeal, and after consulting the chairperson of the Board to which the member concerned belongs, takes a decision to this effect. 7. The President of the Boards of Appeal and the chairpersons and members of the Boards of Appeal shall be independent. In their decisions, they shall not be bound by any instructions. 8. Decisions taken by the Grand Board on appeals or opinions on questions of law referred to it by the Executive Director pursuant to Article 165 shall be binding on the decision-making instances of the Office listed in Article 159. 9. The President of the Boards of Appeal and the chairpersons and members of the Boards of Appeal shall not be examiners or members of the Opposition Divisions, the Department in charge of the Register or Cancellation Divisions. Article 167 Presidium of the Boards of Appeal and Grand Board 1. The Presidium shall comprise the President of the Boards of Appeal, who shall chair it, the chairmen of the Boards and Board members elected for each calendar year by and from among all the members of the Boards other than the President of the Boards of Appeal and the chairmen of the Boards. The number of Board members so elected shall constitute a quarter of the number of Board members, other than the President of the Boards of Appeal and the chairmen of the Boards, and that number shall be rounded up if necessary. 2. The Grand Board referred to in Article 165(2) shall comprise nine members, including the President of the Boards of Appeal, the chairmen of the Boards, the rapporteur designated prior to referral to the Grand Board, if applicable, and members drawn in rotation from a list comprising the names of all members of the Boards of Appeal other than the President of the Boards of Appeal and the chairmen of the Boards. Article 168 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details concerning the organisation of the Boards of Appeal, including the setting up and the role of the Presidium, the composition of the Grand Board and the rules on referrals to it, and the conditions under which decisions are to be taken by a single member in accordance with Article 165(2) and (5). Article 169 Exclusion and objection 1. Examiners and members of the Divisions set up within the Office or of the Boards of Appeal may not take part in any proceedings if they have any personal interest therein, or if they have previously been involved as representatives of one of the parties. Two of the three members of an Opposition Division shall not have taken part in examining the application. Members of the Cancellation Divisions may not take part in any proceedings if they have participated in the final decision on the case in the proceedings for registration or opposition proceedings. Members of the Boards of Appeal may not take part in appeal proceedings if they participated in the decision under appeal. 2. If, for one of the reasons mentioned in paragraph 1 or for any other reason, a member of a Division or of a Board of Appeal considers that he should not take part in any proceedings, he shall inform the Division or Board accordingly. 3. Examiners and members of the Divisions or of a Board of Appeal may be objected to by any party for one of the reasons mentioned in paragraph 1, or if suspected of partiality. An objection shall not be admissible if, while being aware of a reason for objection, the party has taken a procedural step. No objection may be based upon the nationality of examiners or members. 4. The Divisions and the Boards of Appeal shall decide as to the action to be taken in the cases specified in paragraphs 2 and 3 without the participation of the member concerned. For the purposes of taking this decision the member who withdraws or has been objected to shall be replaced in the Division or Board of Appeal by his alternate. Article 170 Mediation centre 1. For the purposes of Article 151(3), the Office may establish a Mediation Centre (\u2018the Centre\u2019). 2. Any natural or legal person may use the Centre's services on a voluntary basis with the aim of reaching a friendly settlement of disputes, based on this Regulation or Regulation (EC) No 6/2002, by mutual agreement. 3. The parties shall have recourse to mediation by means of a joint request. The request shall not be deemed to have been filed until the corresponding charge has been paid. The Executive Director shall fix the amount to be charged in accordance with Article 178(1). 4. In the case of disputes subject to the proceedings pending before the Opposition Divisions, Cancellation Divisions or before the Boards of Appeal of the Office a joint request for mediation may be presented at any time after the lodging of a notice of opposition, an application for revocation or an application for a declaration of invalidity or a notice of appeal against decisions of the Opposition or Cancellation Divisions. 5. The proceedings in question shall be suspended and the time periods, other than the time periods for the payment of the applicable fee, shall be interrupted as from the date of the filing of a joint request for mediation. The time periods shall continue as from the day on which the proceedings are resumed. 6. The parties shall be invited to jointly appoint, from the list referred to in paragraph 12, a mediator who has declared that he has a command of the language of the mediation in question. Where the parties do not appoint a mediator within 20 days of the invitation to do so, the mediation shall be deemed to have failed. 7. The parties shall agree together with the mediator on the detailed arrangements for the mediation in a mediation agreement. 8. The mediator shall conclude the mediation proceedings as soon as the parties reach a settlement agreement, or one of the parties declares that it wishes to end the mediation or the mediator establishes that the parties have failed to reach such an agreement. 9. The mediator shall inform the parties as well as the relevant instance of the Office as soon as the mediation proceedings have been concluded. 10. The discussions and negotiations conducted within the framework of mediation shall be confidential for all persons involved in the mediation, in particular for the mediator, the parties and their representatives. All documents and information submitted during the mediation shall be kept separately from, and shall not be part of, the file of any other proceedings before the Office. 11. The mediation shall be conducted in one of the official languages of the Union to be agreed upon by the parties. Where the mediation relates to disputes pending before the Office, the mediation shall be conducted in the language of the Office proceedings, unless otherwise agreed by the parties. 12. The Office shall establish a list of mediators who shall support parties in resolving disputes. The mediators shall be independent and possess relevant skills and experience. The list may include mediators who are employed by the Office, and mediators who are not so employed. 13. Mediators shall be impartial in the exercise of their duties and shall declare any real or perceived conflict of interest upon their designation. Members of the decision-making instances of the Office listed in Article 159 shall not take part in mediation concerning a case in which they have: (a) had any prior involvement in the proceedings referred to mediation; (b) any personal interest in those proceedings; or (c) been previously involved as a representative of one of the parties. 14. Mediators shall not take part as members of the decision-making instances of the Office listed in Article 159 in proceedings resumed as a consequence of a mediation failure. 15. The Office may cooperate with other recognised national or international bodies dealing with mediation. SECTION 6 Budget and financial control Article 171 Budget Committee 1. The Budget Committee shall have the functions assigned to it in this Section. 2. Articles 154 and 155, Article 156(1) to (4), and (5), in so far as it relates to the election of the chairperson and deputy chairperson, and Article 156(6) and (7) shall apply to the Budget Committee, mutatis mutandis. 3. The Budget Committee shall take its decisions by an absolute majority of its members. However, a majority of two-thirds of its members shall be required for the decisions which the Budget Committee is empowered to take under Article 173(3) and Article 177. In both cases each member shall have one vote. Article 172 Budget 1. Estimates of all the Office's revenue and expenditure shall be prepared for each financial year and shall be shown in the Office's budget. Each financial year shall correspond to the calendar year. 2. The revenue and expenditure shown in the budget shall be in balance. 3. Revenue shall comprise, without prejudice to other types of income, total fees payable under Annex I to this Regulation, total fees as provided for in Regulation (EC) No 6/2002, total fees payable, under the Madrid Protocol, for an international registration designating the Union, and other payments made to Contracting Parties to the Madrid Protocol, total fees payable, under the Geneva Act referred to in Article 106c of Regulation (EC) No 6/2002, for an international registration designating the Union and other payments made to Contracting Parties to the Geneva Act, and, to the extent necessary, a subsidy entered against a specific heading of the Commission section of the general budget of the Union. 4. Every year the Office shall offset the costs incurred by the central industrial property offices of the Member States, by the Benelux Office for Intellectual Property and by any other relevant authority to be nominated by a Member State, as the result of the specific tasks which they carry out as functional parts of the EU trade mark system in the context of the following services and procedures: (a) opposition and invalidity proceedings before the central industrial property offices of the Member States and the Benelux Office for Intellectual Property involving EU trade marks; (b) provision of information on the functioning of the EU trade mark system through helpdesks and information centres; (c) enforcement of EU trade marks, including action taken pursuant to Article 9(4). 5. The overall offsetting of the costs identified in paragraph 4 shall correspond to 5 % of the yearly revenue of the Office. Without prejudice to the third subparagraph of this paragraph, on a proposal by the Office and after having consulted the Budget Committee, the Management Board shall determine the distribution key on the basis of the following fair, equitable and relevant indicators: (a) the annual number of EU trade mark applications originating from applicants in each Member State; (b) the annual number of national trade mark applications in each Member State; (c) the annual number of oppositions and applications for a declaration of invalidity submitted by proprietors of EU trade marks in each Member State; (d) the annual number of cases brought before the EU trade mark courts designated by each Member State in accordance with Article 123. For the purpose of substantiating the costs referred to in paragraph 4, Member States shall submit to the Office by 31 March of each year, statistical data demonstrating the figures referred to in points (a) to (d) of the first subparagraph of this paragraph for the preceding year, which shall be included in the proposal to be made to the Management Board. On grounds of equity, the costs incurred by the bodies referred to in paragraph 4 in each Member State shall be deemed to correspond to at least 2 % of the total offsetting provided for under this paragraph. 6. The obligation by the Office to offset the costs referred to in paragraph 4 and incurred in a given year shall only apply to the extent that no budgetary deficit occurs in that year. 7. In the event of a budgetary surplus, and without prejudice to paragraph 10, on a proposal by the Office and after having consulted the Budget Committee, the Management Board may increase the percentage laid down in paragraph 5 to a maximum of 10 % of the yearly revenue of the Office. 8. Without prejudice to paragraphs 4 to 7 and paragraph 10 of this Article and to Articles 151 and 152, where a substantive surplus is generated over five consecutive years, the Budget Committee, upon a proposal from the Office and in accordance with the annual work programme and multiannual strategic programme referred to in Article 153(1)(a) and (b), shall decide by a two-thirds majority on the transfer to the budget of the Union of a surplus generated from 23 March 2016. 9. The Office shall prepare on a biannual basis a report for the European Parliament, the Council and the Commission on its financial situation, including on the financial operations performed under Article 152(5) and (6), and paragraphs 5 and 7 of this Article. On the basis of that report, the Commission shall review the financial situation of the Office. 10. The Office shall provide for a reserve fund covering one year of its operational expenditure to ensure the continuity of its operations and the execution of its tasks. Article 173 Preparation of the budget 1. The Executive Director shall draw up each year an estimate of the Office's revenue and expenditure for the following year and shall send it to the Budget Committee not later than 31 March in each year, together with a list of posts. 2. Should the budget estimates provide for a Union subsidy, the Budget Committee shall immediately forward the estimate to the Commission, which shall forward it to the budget authority of the Union. The Commission may attach an opinion on the estimate along with an alternative estimate. 3. The Budget Committee shall adopt the budget, which shall include the Office's list of posts. Should the budget estimates contain a subsidy from the general budget of the Union, the Office's budget shall, if necessary, be adjusted. Article 174 Audit and control 1. An internal audit function shall be set up within the Office, to be performed in compliance with the relevant international standards. The internal auditor, appointed by the Executive Director, shall be responsible to him for verifying the proper operation of budget implementation systems and procedures of the Office. 2. The internal auditor shall advise the Executive Director on dealing with risks, by issuing independent opinions on the quality of management and control systems and by issuing recommendations for improving the conditions of implementation of operations and promoting sound financial management. 3. The responsibility for putting in place internal control systems and procedures suitable for carrying out his tasks shall lie with the authorising officer. Article 175 Combating fraud 1. In order to facilitate combating fraud, corruption and other unlawful activities under Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (25), the Office shall accede to the Inter-institutional Agreement of 25 May 1999 concerning internal investigations by OLAF, and adopt the appropriate provisions applicable to all the employees of the Office using the template set out in the Annex to that Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds from the Office. 3. OLAF may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96 (26) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant or a contract funded by the Office. 4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and international organisations, contracts, grant agreements and grant decisions of the Office shall contain provisions expressly empowering the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences. 5. The Budget Committee shall adopt an anti-fraud strategy which is proportionate to the fraud risks having regard to the cost-benefit of the measures to be implemented. Article 176 Auditing of accounts 1. Not later than 31 March in each year the Executive Director shall transmit to the Commission, the European Parliament, the Budget Committee and the Court of Auditors accounts of the Office's total revenue and expenditure for the preceding financial year. The Court of Auditors shall examine them in accordance with Article 287 TFEU. 2. The Budget Committee shall give a discharge to the Executive Director in respect of the implementation of the budget. Article 177 Financial provisions The Budget Committee shall, after consulting the Court of Auditors and the Commission, adopt internal financial provisions specifying, in particular, the procedure for establishing and implementing the Office's budget. As far as is compatible with the particular nature of the Office, the financial provisions shall be based on the financial regulations adopted for other bodies set up by the Union. Article 178 Fees and charges and due date 1. The Executive Director shall lay down the amount to be charged for any services rendered by the Office other than those set out in Annex I, as well as the amount to be charged for the European Union Trade Marks Bulletin, the Official Journal of the Office and any other publications issued by the Office. The amounts of charges shall be set in euros and shall be published in the Official Journal of the Office. The amount of each charge shall not exceed what is necessary to cover the costs of the specific service rendered by the Office. 2. Fees and charges in respect of which the due date is not specified in this Regulation shall be due on the date of receipt of the request for the service for which the fee or the charge is incurred. With the consent of the Budget Committee, the Executive Director may determine which of the services mentioned in the first subparagraph are not to be dependent upon the advance payment of the corresponding fees or charges. Article 179 Payment of fees and charges 1. Fees and charges due to the Office shall be paid by payment or transfer to a bank account held by the Office. With the consent of the Budget Committee, the Executive Director may establish which specific methods of payment other than those set out in the first subparagraph, in particular by means of deposits in current accounts held with the Office, may be used. Determinations made pursuant to the second subparagraph shall be published in the Official Journal of the Office. All payments, including by any other method of payment established pursuant to the second subparagraph, shall be made in euros. 2. Every payment shall indicate the name of the person making the payment and shall contain the necessary information to enable the Office to establish immediately the purpose of the payment. In particular, the following information shall be provided: (a) when the application fee is paid, the purpose of the payment, namely \u2018application fee\u2019; (b) when the opposition fee is paid, the file number of the application and the name of the applicant for the EU trade mark against which opposition is entered, and the purpose of the payment, namely \u2018opposition fee\u2019; (c) when the revocation fee and the invalidity fee are paid, the registration number and the name of the proprietor of the EU trade mark against which the application is directed, and the purpose of the payment, namely \u2018revocation fee\u2019 or \u2018invalidity fee\u2019. 3. If the purpose of the payment referred to in paragraph 2 cannot immediately be established, the Office shall require the person making the payment to notify it in writing of this purpose within such period as it may specify. If the person does not comply with this request in due time, the payment shall be considered not to have been made. The amount which has been paid shall be refunded. Article 180 Deemed date of payment 1. In the cases referred to in the first subparagraph of Article 179(1), the date on which the payment shall be considered to have been made to the Office shall be the date on which the amount of the payment or of the transfer is actually entered in a bank account held by the Office. 2. Where the methods of payment referred to in the second subparagraph of Article 179(1) may be used, the Executive Director shall establish the date on which such payments are to be considered to have been made. 3. Where, under paragraphs 1 and 2, payment of a fee is not considered to have been made until after the expiry of the period in which it was due, it shall be considered that this period has been observed if evidence is provided to the Office that the persons who made the payment in a Member State, within the period within which the payment should have been made, duly gave an order to a banking establishment to transfer the amount of the payment, and paid a surcharge of 10 % of the relevant fee or fees, but not exceeding EUR 200. No surcharge shall be payable if the relevant order to the banking establishment has been given not later than 10 days before the expiry of the period for payment. 4. The Office may request the person who made the payment to produce evidence as to the date on which the order to the banking establishment as referred to in paragraph 3 was given and, where required, to pay the relevant surcharge within a period to be specified by it. If the person fails to comply with that request or if the evidence is insufficient, or if the required surcharge is not paid in due time, the period for payment shall be considered not to have been observed. Article 181 Insufficient payments and refund of insignificant amounts 1. A time limit for payment shall, in principle, be considered to have been observed only if the full amount of the fee has been paid in due time. If the fee is not paid in full, the amount which has been paid shall be refunded after the period for payment has expired. 2. The Office may, however, in so far as is possible within the time remaining before the end of the period, give the person making the payment the opportunity to pay the amount lacking or, where this is considered justified, overlook any small amounts lacking, without prejudice to the rights of the person making the payment. 3. With the consent of the Budget Committee, the Executive Director may waive action for the enforced recovery of any sum due where the sum to be recovered is minimal or where such recovery is too uncertain. 4. Where an excessive sum is paid to cover a fee or a charge, the excess shall not be refunded if the amount is insignificant and the party concerned has not expressly requested a refund. With the consent of the Budget Committee the Executive Director may determine the amount below which an excessive sum paid to cover a fee or a charge shall not be refunded. Determinations pursuant to the second subparagraph shall be published in the Official Journal of the Office. CHAPTER XIII INTERNATIONAL REGISTRATION OF MARKS SECTION I General provisions Article 182 Application of provisions Unless otherwise specified in this chapter, this Regulation and the acts adopted pursuant to this Regulation shall apply to applications for international registrations under the Madrid Protocol (\u2018international applications\u2019), based on an application for an EU trade mark or on an EU trade mark and to registrations of marks in the international register maintained by the International Bureau of the World Intellectual Property Organisation (\u2018international registrations\u2019 and \u2018the International Bureau\u2019, respectively) designating the Union. SECTION 2 International registration on the basis of applications for an EU trade mark and of EU trade marks Article 183 Filing of an international application 1. International applications pursuant to Article 3 of the Madrid Protocol based on an application for an EU trade mark or on an EU trade mark shall be filed at the Office. 2. Where an international application is filed before the mark on which the international registration is to be based has been registered as an EU trade mark, the applicant for the international registration shall indicate whether the international registration is to be based on an EU trade mark application or registration. Where the international registration is to be based on an EU trade mark once it is registered, the international application shall be deemed to have been received at the Office on the date of registration of the EU trade mark. Article 184 Form and contents of the international application 1. The international application shall be filed in one of the official languages of the Union, using a form provided by the Office. The Office shall inform the applicant filing the international application of the date on which the documents making up the international application are received by the Office. Unless otherwise specified by the applicant on form when he files the international application, the Office shall correspond with the applicant in the language of filing in a standard form. 2. If the international application is filed in a language which is not one of the languages allowed under the Madrid Protocol, the applicant shall indicate a second language from among those languages. This shall be the language in which the Office submits the international application to the International Bureau. 3. Where the international application is filed in a language other than one of the languages allowed under the Madrid Protocol for the filing of international applications, the applicant may provide a translation of the list of goods or services and of any other textual elements forming part of the international application in the language in which the international application is to be submitted to the International Bureau pursuant to paragraph 2. If the application is not accompanied by such translation, the applicant shall authorise the Office to include that translation in the international application. Where the translation has not yet been established in the course of the registration procedure for the EU trade mark application on which the international application is based, the Office shall, without delay, arrange for the translation. 4. The filing of an international application shall be subject to the payment of a fee to the Office. Where the international registration is to be based on an EU trade mark once it is registered, the fee shall be due on the date of registration of the EU trade mark. The application shall be deemed not to have been filed until the required fee has been paid. Where the fee has not been paid, the Office shall inform the applicant accordingly. In the event of electronic filing, the Office may authorise the International Bureau to collect the fee on its behalf. 5. Where the examination of the international application reveals any of the following deficiencies, the Office shall invite the applicant to remedy those deficiencies within such period as it may specify: (a) the international application has not been filed using the form referred to in paragraph 1, and does not contain all the indications and information required by that form; (b) the list of goods and services contained in the international application is not covered by the list of goods and services appearing in the basic EU trade mark application or basic EU trade mark; (c) the mark which is subject to the international application is not identical with the mark as it appears in the basic EU trade mark application or basic EU trade mark; (d) an indication in the international application as to the trade mark, other than a disclaimer or a colour claim, does not also appear in the basic EU trade mark application or basic EU trade mark; (e) where colour is claimed in the international application as a distinctive feature of the mark, the basic EU trade mark application or basic EU trade mark is not in the same colour or colours; or (f) according to the indications made in the international form, the applicant is not eligible to file an international application through the Office in accordance with Article 2(1)(ii) of the Madrid Protocol. 6. Where the applicant has failed to authorise the Office to include a translation as provided for in paragraph 3, or where it is otherwise unclear on which list of goods and services the international application is to be based, the Office shall invite the applicant to make the required indications within such period as it may specify. 7. If the deficiencies referred to in paragraph 5 are not remedied or the required indications referred to in paragraph 6 are not given within the period fixed by the Office, the Office shall refuse to forward the international application to the International Bureau. 8. The Office shall forward the international application to the International Bureau along with the certification provided for under Article 3(1) of the Madrid Protocol as soon as the international application meets the requirements laid down in this Article, the implementing act adopted pursuant to paragraph 9 of this Article, and in Article 183 of this Regulation. 9. The Commission shall adopt implementing acts specifying the exact form, including the elements thereof, to be used for the filing of an international application pursuant to paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 185 Recordal in the files and in the Register 1. The date and number of an international registration based on an EU trade mark application shall be recorded in the files of that application. When the application results in an EU trade mark, the date and number of the international registration shall be entered in the Register. 2. The date and number of an international registration based on an EU trade mark shall be entered in the Register. Article 186 Notification of the invalidity of the basic application or registration 1. Within a period of five years of the date of the international registration, the Office shall notify the International Bureau of any facts and decisions affecting the validity of the EU trade mark application or the EU trade mark registration on which the international registration was based. 2. The Commission shall adopt implementing acts specifying the individual facts and decisions subject to the notification obligation in accordance with Article 6(3) of the Madrid Protocol as well as the relevant point in time of such notifications. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2) of this Regulation. Article 187 Request for territorial extension subsequent to international registration 1. A request for territorial extension made subsequent to an international registration pursuant to Article 3ter(2) of the Madrid Protocol may be filed through the intermediary of the Office. The request shall be filed in the language in which the international application was filed pursuant to Article 184 of this Regulation. It shall include indications to substantiate the entitlement to make a designation in accordance with Article 2(1)(ii) and Article 3ter(2) of the Madrid Protocol. The Office shall inform the applicant requesting the territorial extension of the date on which the request for territorial extension was received. 2. The Commission shall adopt implementing acts specifying the detailed requirements regarding the request for territorial extension pursuant to paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 3. Where the request for territorial extension made subsequent to the international registration does not comply with the requirements set out in paragraph 1 and in the implementing act adopted pursuant to paragraph 2, the Office shall invite the applicant to remedy the deficiencies found within such time limit as it may specify. If the deficiencies are not remedied within the time limit fixed by the Office, the Office shall refuse to forward the request to the International Bureau. The Office shall not refuse to forward the request to the International Bureau before the applicant has had the opportunity to correct any deficiency detected in the request. 4. The Office shall forward the request for territorial extension made subsequent to the international registration to the International Bureau as soon as the requirements referred to in paragraph 3 are complied with. Article 188 International fees Any fees payable to the International Bureau under the Madrid Protocol shall be paid direct to the International Bureau. SECTION 3 International registrations designating the Union Article 189 Effects of international registrations designating the Union 1. An international registration designating the Union shall, from the date of its registration pursuant to Article 3(4) of the Madrid Protocol or from the date of the subsequent designation of the Union pursuant to Article 3ter(2) of the Madrid Protocol, have the same effect as an application for an EU trade mark. 2. If no refusal has been notified in accordance with Article 5(1) and (2) of the Madrid Protocol or if any such refusal has been withdrawn, the international registration of a mark designating the Union shall, from the date referred to in paragraph 1, have the same effect as the registration of a mark as an EU trade mark. 3. For the purposes of applying Article 11 of this Regulation, publication of the particulars of the international registration designating the Union pursuant to Article 190(1) shall take the place of publication of an EU trade mark application, and publication pursuant to Article 190(2) shall take the place of publication of the registration of an EU trade mark. Article 190 Publication 1. The Office shall publish the date of registration of a mark designating the Union pursuant to Article 3(4) of the Madrid Protocol or the date of the subsequent designation of the Union pursuant to Article 3ter(2) of the Madrid Protocol, the language of filing of the international application and the second language indicated by the applicant, the number of the international registration and the date of publication of such registration in the Gazette published by the International Bureau, a reproduction of the mark and the numbers of the classes of the goods or services in respect of which protection is claimed. 2. If no refusal of protection of an international registration designating the Union has been notified in accordance with Article 5(1) and (2) of the Madrid Protocol or if any such refusal has been withdrawn, the Office shall publish this fact, together with the number of the international registration and, where applicable, the date of publication of such registration in the Gazette published by the International Bureau. Article 191 Seniority claimed in an international application 1. The applicant for an international registration designating the Union may claim, in the international application, the seniority of an earlier trade mark registered in a Member State, including a trade mark registered in the Benelux countries, or registered under international arrangements having effect in a Member State, as provided for in Article 39. 2. The documentation, as specified in the implementing act adopted pursuant to Article 39(6), in support of the seniority claim shall be submitted within three months of the date on which the International Bureau notifies the international registration to the Office. In this regard, Article 39(7) shall apply. 3. Where the holder of the international registration is obliged to be represented before the Office pursuant to Article 119(2), the communication as referred to in paragraph 2 of this Article shall contain the appointment of a representative within the meaning of Article 120(1). 4. Where the Office finds that the seniority claim under paragraph 1 of this Article does not comply with Article 39, or does not comply with the other requirements laid down in this Article, it shall invite the applicant to remedy the deficiencies. If the requirements referred to in the first sentence are not satisfied within the time limit specified by the Office, the right of seniority in respect of that international registration shall be lost. If the deficiencies concern only some of the goods and services, the right of seniority shall be lost only in so far as those goods and services are concerned. 5. The Office shall inform the International Bureau of any declaration of a loss of the right of seniority pursuant to paragraph 4. It shall also inform the International Bureau of any withdrawal or restriction of the seniority claim. 6. Article 39(5) shall apply, unless the right of seniority is declared lost pursuant to paragraph 4 of this Article. Article 192 Seniority claimed before the Office 1. The holder of an international registration designating the Union may, as from the date of publication of the effects of such registration pursuant to Article 190(2), claim at the Office the seniority of an earlier trade mark registered in a Member State, including a trade mark registered in the Benelux countries, or registered under international arrangements having effect in a Member State, as provided for in Article 40. 2. When the seniority is claimed before the date referred to in paragraph 1, the seniority claim shall be deemed to have been received by the Office on that date. 3. A seniority claim under paragraph 1 of this Article shall fulfil the requirements referred to in Article 40 and shall contain information to enable its examination against those requirements. 4. If the requirements governing the claiming of seniority referred to in paragraph 3 and specified in the implementing act adopted pursuant to paragraph 6 are not fulfilled, the Office shall invite the holder of the international registration to remedy the deficiencies. If the deficiencies are not remedied within a period to be specified by the Office, the Office shall reject the claim. 5. Where the Office has accepted the seniority claim, or where a seniority claim has been withdrawn or cancelled by the Office, the Office shall inform the International Bureau accordingly. 6. The Commission shall adopt implementing acts specifying the details to be contained in a seniority claim under paragraph 1 of this Article and the details of the information to be notified pursuant to paragraph 5 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 193 Designation of goods and services and examination as to absolute grounds for refusal 1. International registrations designating the Union shall be subject to examination as to their conformity with Article 33(2), (3) and (4) and to absolute grounds for refusal in the same way as applications for EU trade marks. 2. Where an international registration designating the Union is found to be ineligible for protection pursuant to Article 33(4) or Article 42(1) of this Regulation for all or any part of the goods and services for which it has been registered by the International Bureau, the Office shall issue an ex officio provisional notification of refusal to the International Bureau, in accordance with Article 5(1) and (2) of the Madrid Protocol. 3. Where the holder of an international registration is obliged to be represented before the Office pursuant to Article 119(2), the notification referred to in paragraph 2 of this Article shall contain an invitation to appoint a representative within the meaning of Article 120(1). 4. The notification of provisional refusal shall state the reasons on which it is based, and shall specify a time period by which the holder of the international registration may submit his observations and, if appropriate, shall appoint a representative. The time period shall start on the day on which the Office issues the provisional refusal. 5. Where the Office finds that the international application designating the Union does not contain the indication of a second language pursuant to Article 206 of this Regulation, the Office shall issue an ex officio provisional notification of refusal to the International Bureau pursuant to Article 5(1) and (2) of the Madrid Protocol. 6. Where the holder of an international registration fails to overcome the ground for refusing protection within the time limit or, if appropriate, to appoint a representative or to indicate a second language, the Office shall refuse the protection in whole or for part of the goods and services for which the international registration is registered. The refusal of protection shall take the place of a refusal of an EU trade mark application. The decision shall be subject to appeal in accordance with Articles 66 to 72. 7. Where, as of the start of the opposition period referred to in Article 196(2), the Office has not issued an ex officio provisional notification of refusal pursuant to paragraph 2 of this Article, it shall send a statement to the International Bureau, indicating that the examination of absolute grounds of refusal pursuant to Article 42 has been completed but that the international registration is still subject to oppositions or observations of third parties. This interim statement shall be without prejudice to the right of the Office to re-open the examination of absolute grounds on its own initiative any time before the final statement of grant of protection has been issued. 8. The Commission shall adopt implementing acts specifying the details to be contained in the notification of ex officio provisional refusal of protection to be sent to the International Bureau and in the final communications to be sent to the International Bureau on the final grant or refusal of protection. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 194 Collective and certification marks 1. Where an international registration is based on a basic application or basic registration relating to a collective mark, certification mark or guarantee mark, the international registration designating the Union shall be dealt with as an EU collective mark or as an EU certification mark, whichever is applicable. 2. The holder of the international registration shall submit the regulations governing the use of the mark, as provided for in Articles 75 and 84, directly to the Office within two months of the date on which the International Bureau notifies the international registration to the Office. 3. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details of the procedure concerning international registrations based on a basic application or basic registration relating to a collective mark, certification mark or guarantee mark. Article 195 Search 1. Once the Office has received a notification of an international registration designating the Union, it shall draw up a Union search report as provided for in Article 43(1) provided that a request for a search report, pursuant to Article 43(1), is made to the Office within one month of the date of notification. 2. As soon as the Office has received a notification of an international registration designating the Union, the Office shall transmit a copy thereof to the central industrial property office of each Member State which has informed the Office of its decision to operate a search in its own register of trade marks as provided for in Article 43(2) provided that a request for a search report, pursuant to Article 43(2), is made to the Office within one month of the date of notification and the search fee is paid within the same period. 3. Article 43(3) to (6) shall apply mutatis mutandis. 4. The Office shall inform the proprietors of any earlier EU trade marks or EU trade mark applications cited in the Union search report of the publication of the international registration designating the Union as provided for in Article 190(1). This shall apply whether or not the holder of the international registration has requested to receive the EU search report, unless the proprietor of an earlier registration or application requests not to receive the notification. Article 196 Opposition 1. International registration designating the Union shall be subject to opposition in the same way as published EU trade mark applications. 2. Notice of opposition shall be filed within a period of three months which shall begin one month following the date of the publication pursuant to Article 190(1). The opposition shall not be considered as duly entered until the opposition fee has been paid. 3. Refusal of protection shall take the place of refusal of an EU trade mark application. 4. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the procedure for the filing and examination of an opposition, including the necessary communications to be made to the International Bureau. Article 197 Replacement of an EU trade mark by an international registration The Office shall, upon request, enter a notice in the Register that an EU trade mark is deemed to have been replaced by an international registration in accordance with Article 4bis of the Madrid Protocol. Article 198 Invalidation of the effects of an international registration 1. The effects of an international registration designating the Union may be declared invalid. 2. The application for invalidation of the effects of an international registration designating the Union shall take the place of an application for a declaration of revocation as provided for in Article 58 or for a declaration of invalidity as provided for in Article 59 or Article 60. 3. Where pursuant to Article 64 or Article 128 of this Regulation and this Article, the effects of an international registration designating the Union have been declared invalid by means of a final decision, the Office shall notify the International Bureau in accordance with Article 5(6) of the Madrid Protocol. 4. The Commission shall adopt implementing acts specifying the details to be contained in the notification to be made to the International Bureau pursuant to paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 199 Legal effect of registration of transfers The recordal of a change in the ownership of an international registration on the International Register shall have the same effect as the entry of a transfer in the Register pursuant to Article 20. Article 200 Legal effect of registration of licences and other rights The recordal of a licence or a restriction of the holder's right of disposal in respect of an international registration in the International Register shall have the same effect as the registration of a right in rem, a levy of execution, insolvency proceedings or a licence in the Register pursuant to Articles 22, 23, 24 and 25 respectively. Article 201 Examination of requests for registration of transfers, licences or restrictions of a holder's right of disposal The Office shall transmit requests to register a change in ownership, a licence or a restriction of the holder's right of disposal, the amendment or cancellation of a licence or the removal of a restriction of the holder's right of disposal which have been filed with it to the International Bureau, if accompanied by appropriate proof of the transfer, licence, or the restriction of the right of disposal, or by proof that the licence no longer exists or that it has been amended, or that the restriction of the right of disposal has been removed. Article 202 Conversion of a designation of the Union through an international registration into a national trade mark application or into a designation of Member States 1. Where a designation of the Union through an international registration has been refused or ceases to have effect, the holder of the international registration may request the conversion of the designation of the Union: (a) into a national trade mark application pursuant to Articles 139, 140 and 141; (b) into a designation of a Member State party to the Madrid Protocol, provided that on the date when conversion was requested it was possible to have designated that Member State directly under the Madrid Protocol. Articles 139, 140 and 141 of this Regulation shall apply. 2. The national trade mark application or the designation of a Member State party to the Madrid Protocol resulting from the conversion of the designation of the Union through an international registration shall enjoy, in respect of the Member State concerned, the date of the international registration pursuant to Article 3(4) of the Madrid Protocol or the date of the extension to the Union pursuant to Article 3ter(2) of the Madrid Protocol, if the latter was made subsequent to the international registration, or the date of priority of that registration and, where appropriate, the seniority of a trade mark of that State claimed under Article 191 of this Regulation. 3. The request for conversion shall be published. 4. The request for conversion of an international registration designating the Union into a national trade mark application shall include the information and indications referred to in Article 140(1). 5. Where conversion is requested pursuant to this Article and Article 139(5) of this Regulation following a failure to renew the international registration, the request referred to in paragraph 4 of this Article shall contain an indication to that effect and the date on which the protection expired. The period of three months provided for in Article 139(5) of this Regulation shall begin to run on the day following the last day on which the renewal may still be effected pursuant to Article 7(4) of the Madrid Protocol. 6. Article 140(3) and (5) shall apply to the request for conversion referred to in paragraph 4 of this Article mutatis mutandis. 7. The request for conversion of an international registration designating the Union into a designation of a Member State party to the Madrid Protocol shall include the indications and elements referred to in paragraphs 4 and 5. 8. Article 140(3) shall apply to the request for conversion referred to in paragraph 7 of this Article mutatis mutandis. The Office shall also reject the request for conversion where the conditions to designate the Member State which is a party to the Madrid Protocol or to the Madrid Agreement were fulfilled neither on the date of the designation of the Union nor on the date on which the application for conversion was received or, pursuant to the last sentence of Article 140(1), is deemed to have been received by the Office. 9. Where the request for conversion referred to in paragraph 7 complies with the requirements of this Regulation and rules adopted pursuant to it, the Office shall transmit the request without delay to the International Bureau. The Office shall inform the holder of the international registration of the date of transmission. 10. The Commission shall adopt implementing acts specifying: (a) the details to be contained in the requests for conversion referred to in paragraphs 4 and 7; (b) the details to be contained in the publication of the requests for conversion pursuant to paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 203 Use of a mark subject of an international registration For the purposes of applying Article 18(1), Article 47(2), Article 58(1)(a) and Article 64(2), the date of publication pursuant to Article 190(2) shall take the place of the date of registration for the purpose of establishing the date as from which the mark which is the subject of an international registration designating the Union shall be put to genuine use in the Union. Article 204 Transformation 1. Subject to paragraph 2, the provisions applicable to EU trade mark applications shall apply mutatis mutandis to applications for transformation of an international registration into an EU trade mark application pursuant to Article 9quinquies of the Madrid Protocol. 2. When the application for transformation relates to an international registration designating the Union the particulars of which have been published pursuant to Article 190(2), Articles 42 to 47 shall not apply. 3. In order to be considered a transformation of an international registration which has been cancelled at the request of the office of origin by the International Bureau pursuant to Article 9quinquies of the Madrid Protocol, an EU trade mark application shall contain an indication to that effect. That indication shall be made when filing the application. 4. Where, in the course of the examination in accordance with Article 41(1)(b), the Office finds that the application was not filed within three months of the date on which the international registration was cancelled by the International Bureau, or the goods and services for which the EU trade mark is to be registered are not contained in the list of goods and services for which the international registration was registered in respect of the Union, the Office shall invite the applicant to remedy the deficiencies. 5. If the deficiencies referred to in paragraph 4 are not remedied within the time period specified by the Office, the right to the date of the international registration or the territorial extension and, if any, of the priority of the international registration shall be lost. 6. The Commission shall adopt implementing acts specifying the details to be contained in an application for transformation pursuant to paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 205 Communication with the International Bureau Communication with the International Bureau shall be in a manner and format agreed on between the International Bureau and the Office, and preferably be by electronic means. Any reference to forms shall be construed as including forms made available in electronic format. Article 206 Use of languages For the purpose of applying this Regulation, and rules adopted pursuant to it, to international registrations designating the Union, the language of filing of the international application shall be the language of the proceedings within the meaning of Article 146(4), and the second language indicated in the international application shall be the second language within the meaning of Article 146(3). CHAPTER XIV FINAL PROVISIONS Article 207 Committee Procedure 1. The Commission shall be assisted by a Committee on Implementation Rules. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 208 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 48, Article 49(3), Articles 65 and 73, Articles 96(4), 97(6), 98(5), 100(2), 101(5), 103(3), and 106(3), Articles 121 and 168, and Articles 194(3) and 196(4) shall be conferred on the Commission for an indeterminate period of time from 23 March 2016. 3. The delegation of power referred to in Article 48, Article 49(3), Articles 65 and 73, Articles 96(4), 97(6), 98(5), 100(2), 101(5), 103(3), and 106(3), Articles 121 and 168, and Articles 194(3) and 196(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall carry out consultations with experts, including experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 48, Article 49(3), Articles 65 and 73, Articles 96(4), 97(6), 98(5), 100(2), 101(5), 103(3), and 106(3), Articles 121 and 168, and Articles 194(3) and 196(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 209 Provisions relating to the enlargement of the Union 1. As of the date of accession of Bulgaria, the Czech Republic, Estonia, Croatia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Romania, Slovenia and Slovakia (\u2018new Member State(s)\u2019), an EU trade mark registered or applied for pursuant to this Regulation before their respective date of accession shall be extended to the territory of those Member States in order to have equal effect throughout the Union. 2. The registration of an EU trade mark which was under application at the date of accession may not be refused on the basis of any of the absolute grounds for refusal listed in Article 7(1), if these grounds became applicable merely because of the accession of a new Member State. 3. Where an application for the registration of an EU trade mark has been filed during the six months prior to the date of accession, notice of opposition may be given pursuant to Article 46 where an earlier trade mark or another earlier right within the meaning of Article 8 was acquired in a new Member State prior to accession, provided that it was acquired in good faith and that the filing date or, where applicable, the priority date or the date of acquisition in the new Member State of the earlier trade mark or other earlier right precedes the filing date or, where applicable, the priority date of the EU trade mark applied for. 4. An EU trade mark as referred to in paragraph 1 may not be declared invalid: (a) pursuant to Article 59 if the grounds for invalidity became applicable merely because of the accession of a new Member State; (b) pursuant to Article 60(1) and (2) if the earlier national right was registered, applied for or acquired in a new Member State prior to the date of accession. 5. The use of an EU trade mark as referred to in paragraph 1 may be prohibited pursuant to Articles 137 and 138, if the earlier trade mark or other earlier right was registered, applied for or acquired in good faith in the new Member State prior to the date of accession of that State; or, where applicable, has a priority date prior to the date of accession of that State. Article 210 Evaluation and review 1. By 24 March 2021, and every five years thereafter, the Commission shall evaluate the implementation of this Regulation. 2. The evaluation shall review the legal framework for cooperation between the Office and the central industrial property offices of the Member States and the Benelux Office for Intellectual Property, paying particular attention to the financing mechanism laid down in Article 152. The evaluation shall further assess the impact, effectiveness and efficiency of the Office and its working practices. The evaluation shall, in particular, address the possible need to modify the mandate of the Office, and the financial implications of any such modification. 3. The Commission shall forward the evaluation report together with its conclusions drawn on the basis of that report to the European Parliament, the Council and the Management Board. The findings of the evaluation shall be made public. 4. On the occasion of every second evaluation, there shall be an assessment of the results achieved by the Office having regard to its objectives, mandate and tasks. Article 211 Repeal Regulation (EC) No 207/2009 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III. Article 212 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 October 2017. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 14 June 2017. For the European Parliament The President A. TAJANI For the Council The President H. DALLI (1) Position of the European Parliament of 27 April 2017 (not yet published in the Official Journal) and decision of the Council of 22 May 2017. (2) Council Regulation (EC) No 207/2009 of 26 February 2009 on the European Union trade mark (OJ L 78, 24.3.2009, p. 1). (3) See Annex II. (4) Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade mark (OJ L 11, 14.1.1994, p. 1). (5) First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks (OJ L 40, 11.2.1989, p. 1). (6) Directive 2008/95/EC of the European Parliament and of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks (OJ L 299, 8.11.2008, p. 25). (7) Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (OJ L 376, 27.12.2006, p. 21). (8) Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15). (9) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (10) OJ L 123, 12.5.2016, p. 1. (11) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (12) Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (OJ L 336, 23.12.2015, p. 1). (13) Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1). (14) Directive 2001/24/EC of the European Parliament and of the Council of 4 April 2001 on the reorganisation and winding up of credit institutions (OJ L 125, 5.5.2001, p. 15). (15) OJ L 56, 4.3.1968, p. 1. (16) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (17) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (18) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). (19) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (20) Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (OJ L 3, 5.1.2002, p. 1). (21) Regulation (EU) No 386/2012 of the European Parliament and of the Council of 19 April 2012 on entrusting the Office for Harmonization in the Internal Market (Trade Marks and Designs) with tasks related to the enforcement of intellectual property rights, including the assembling of public and private-sector representatives as a European Observatory on Infringements of Intellectual Property Rights (OJ L 129, 16.5.2012, p. 1). (22) Directive 2012/28/EU of the European Parliament and of the Council of 25 October 2012 on certain permitted uses of orphan works (OJ L 299, 27.10.2012, p. 5). (23) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (24) Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union (OJ L 362, 31.12.2012, p. 1). (25) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (26) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). ANNEX I AMOUNT OF FEES A. The fees to be paid to the Office under this Regulation shall be as follows (in EUR): 1. Basic fee for the application for an individual EU trade mark (Article 31(2)): EUR 1 000 2. Basic fee for the application for an individual EU trade mark by electronic means (Article 31(2)): EUR 850 3. Fee for the second class of goods and services for an individual EU trade mark (Article 31(2)): EUR 50 4. Fee for each class of goods and services exceeding two for an individual EU trade mark (Article 31(2)): EUR 150 5. Basic fee for the application for an EU collective mark or an EU certification mark (Article 31(2) and Article 74(3) or Article 83(3)): EUR 1 800 6. Basic fee for the application for an EU collective mark or an EU certification mark by electronic means (Article 31(2) and Article 74(3) or Article 83(3)): EUR 1 500 7. Fee for the second class of goods and services for an EU collective mark or an EU certification mark: (Article 31(2) and Article 74(3) or Article 83(3)): EUR 50 8. Fee for each class of goods and services exceeding two for an EU collective mark or an EU certification mark (Article 31(2) and 74(3) or Article 83(3)): EUR 150 9. Search fee for an EU trade mark application (Article 43(2)) or for an international registration designating the Union (Article 43(2) and Article 195(2)): EUR 12 multiplied by the number of central industrial property offices referred to in Article 43(2); that amount, and the subsequent changes, shall be published by the Office in the Official Journal of the Office. 10. Opposition fee (Article 46(3)): EUR 320 11. Basic fee for the renewal of an individual EU trade mark (Article 53(3)): EUR 1 000 12. Basic fee for the renewal of an individual EU trade mark by electronic means (Article 53(3)): EUR 850 13. Fee for the renewal of the second class of goods and services for an individual EU trade mark (Article 53(3)): EUR 50 14. Fee for the renewal of each class of goods and services exceeding two for an individual EU trade mark (Article 53(3)): EUR 150 15. Basic fee for the renewal of an EU collective mark or an EU certification mark (Article 53(3) and Article 74(3) or Article 83(3): EUR 1 800 16. Basic fee for the renewal of an EU collective mark or an EU certification mark by electronic means (Article 53(3) and Article 74(3) or Article 83(3)): EUR 1 500 17. Fee for the renewal of the second class of goods and services for an EU collective mark or an EU certification mark (Article 53(3) and Article 74(3) or Article 83(3)): EUR 50 18. Fee for the renewal of each class of goods and services exceeding two for an EU collective mark or an EU certification mark (Article 53(3) and Article 74(3) or Article 83(3)): EUR 150 19. Additional fee for the late payment of the renewal fee or the late submission of the request for renewal (Article 53(3)): 25 % of the belated renewal fee, subject to a maximum of EUR 1 500 20. Fee for the application for revocation or for a declaration of invalidity (Article 63(2)): EUR 630 21. Appeal fee (Article 68(1)): EUR 720 22. Fee for the application of restitutio in integrum (Article 104(3)): EUR 200 23. Fee for the application for the conversion of an EU trade mark application or an EU trade mark (Article 140(1), also in conjunction with Article 202(1)): (a) into a national trade mark application; (b) into a designation of Member States under the Madrid Protocol: EUR 200 24. Fee for continuation of proceedings (Article 105(1)): EUR 400 25. Fee for the declaration of division of a registered EU trade mark (Article 56(4) or an application for an EU trade mark (Article 50(3)): EUR 250 26. Fee for the application for the registration of a licence or another right in respect of a registered EU trade mark (Article 26(2)) or an application for an EU trade mark (Article 26(2)): (a) grant of a licence; (b) transfer of a licence; (c) creation of a right in rem; (d) transfer of a right in rem; (e) levy of execution: EUR 200 per registration, but where multiple requests are submitted in the same application or at the same time, not to exceed a total of EUR 1 000 27. Fee for the cancellation of the registration of a licence or other right (Article 29(3)): EUR 200 per cancellation, but where multiple requests are submitted in the same application or at the same time, not to exceed a total of EUR 1 000 28. Fee for the alteration of a registered EU trade mark (Article 54(4)): EUR 200 29. Fee for the issue of a copy of the application for an EU trade mark (Article 114(7)), a copy of the certificate of registration (Article 51(2)), or an extract from the register (Article 111(7)): (a) uncertified copy or extract: EUR 10 (b) certified copy or extract: EUR 30 30. Fee for the inspection of the files (Article 114(6)): EUR 30 31. Fee for the issue of copies of file documents (Article 114(7)): (a) uncertified copy: EUR 10 (b) certified copy: EUR 30 plus per page, exceeding 10 EUR 1 32. Fee for the communication of information in a file (Article 114(9)): EUR 10 33. Fee for the review of the determination of the procedural costs to be refunded (Article 109(8)): EUR 100 34. Fee for the filing of an international application at the Office (Article 184(4)): EUR 300 B. Fees to be paid to the International Bureau I. Individual fee for an international registration designating the Union 1. The applicant for an international registration designating the Union shall be required to pay to the International Bureau an individual fee for the designation of the Union in accordance with Article 8(7) of the Madrid Protocol. 2. The holder of an international registration who files a request for territorial extension designating the Union made subsequent to the international registration shall be required to pay to the International Bureau an individual fee for the designation of the Union in accordance with Article 8(7) of the Madrid Protocol. 3. The amount of the fee under points B.I.1 or B.I.2 shall be the equivalent in Swiss Francs, as established by the Director-General of the WIPO pursuant to Rule 35(2) of the Common Regulations under the Madrid Agreement and Protocol, of the following amounts: (a) for an individual trade mark: EUR 820 plus, where applicable, EUR 50 for the second class of goods and services and EUR 150 for each class of goods and services contained in the international registration exceeding two; (b) for a collective mark or a certification mark: EUR 1 400 plus, where applicable, EUR 50 for the second class of goods and services and EUR 150 for each class of goods or services exceeding two. II. Individual fee for a renewal of an international registration designating the Union 1. The holder of an international registration designating the Union shall be required to pay to the International Bureau, as a part of the fees for a renewal of the international registration, an individual fee for the designation of the Union in accordance with Article 8(7) of the Madrid Protocol. 2. The amount of the fee referred to in point B.II.1 shall be the equivalent in Swiss Francs, as established by the Director-General of the WIPO pursuant to Rule 35(2) of the Common Regulations under the Madrid Agreement and Protocol, of the following amounts: (a) for an individual trade mark: EUR 820 plus, where applicable, EUR 50 for the second class of goods and services and EUR 150 for each class of goods and services contained in the international registration exceeding two; (b) for a collective mark or a certification mark: EUR 1 400 plus, where applicable, EUR 50 for the second class of goods and services and EUR 150 for each class of goods and services contained in the international registration exceeding two. ANNEX II Repealed Regulation with list of its successive amendments Council Regulation (EC) No 207/2009 (OJ L 78, 24.3.2009, p. 1) Act of Accession of 2012, Annex III, point 2(I) Regulation (EU) 2015/2424 of the European Parliament and of the Council (OJ L 341, 24.12.2015, p. 21) Only Article 1 ANNEX III Correlation table Regulation (EC) No 207/2009 This Regulation Articles 1 to 7 Articles 1 to 7 Article 8(1) to (4) Article 8(1) to (4) Article 8(4a) Article 8(6) Article 8(5) Article 8(5) Article 9 Article 9 Article 9a Article 10 Article 9b Article 11 Article 10 Article 12 Article 11 Article 13 Article 12 Article 14 Article 13 Article 15 Article 13a Article 16 Article 14 Article 17 Article 15 Article 18 Article 16 Article 19 Article 17(1), (2) and (3) Article 20(1), (2) and (3) Article 17(5) Article 20(4) Article 17(5a) Article 20(5) Article 17(5b) Article 20(6) Article 17(5c) Article 20(7) Article 17(5d) Article 20(8) Article 17(5e) Article 20(9) Article 17(5f) Article 20(10) Article 17(6) Article 20(11) Article 17(7) Article 20(12) Article 17(8) Article 20(13) Article 18 Article 21 Article 19 Article 22 Article 20 Article 23 Article 21 Article 24 Article 22 Article 25 Article 22a Article 26 Article 23 Article 27 Article 24 Article 28 Article 24a Article 29 Article 25 Article 30 Article 26 Article 31 Article 27 Article 32 Article 28 Article 33 Article 29 Article 34 Article 30 Article 35 Article 31 Article 36 Article 32 Article 37 Article 33 Article 38 Article 34(1) Article 39(1) Article 34(1a) Article 39(2) Article 34(2) Article 39(3) Article 34(3) Article 39(4) Article 34(4) Article 39(5) Article 34(5) Article 39(6) Article 34(6) Article 39(7) Article 35 Article 40 Article 36 Article 41 Article 37(1) Article 42(1) Article 37(3) Article 42(2) Article 38 Article 43 Article 39 Article 44 Article 40 Article 45 Article 41 Article 46 Article 42 Article 47 Article 42a Article 48 Article 43 Article 49 Article 44(1) and (2) Article 50(1) and (2) Article 44(4) Article 50(3) Article 44(4a) Article 50(4) Article 44(5) to (9) Article 50(5) to (9) Article 45 Article 51 Article 46 Article 52 Article 47 Article 53 Article 48 Article 54 Article 48a Article 55 Article 49 Article 56 Article 50 Article 57 Article 51 Article 58 Article 52 Article 59 Article 53 Article 60 Article 54 Article 61 Article 55 Article 62 Article 56 Article 63 Article 57 Article 64 Article 57a Article 65 Article 58 Article 66 Article 59 Article 67 Article 60 Article 68 Article 61 Article 69 Article 63 Article 70 Article 64 Article 71 Article 65 Article 72 Article 65a Article 73 Article 66 Article 74 Article 67 Article 75 Article 68 Article 76 Article 69 Article 77 Article 70 Article 78 Article 71 Article 79 Article 72 Article 80 Article 73 Article 81 Article 74 Article 82 Article 74a Article 83 Article 74b Article 84 Article 74c Article 85 Article 74d Article 86 Article 74e Article 87 Article 74f Article 88 Article 74g Article 89 Article 74h Article 90 Article 74i Article 91 Article 74j Article 92 Article 74k Article 93 Article 75 Article 94 Article 76 Article 95 Article 77 Article 96 Article 78 Article 97 Article 79 Article 98 Article 79a Article 99 Article 79b Article 100 Article 79c Article 101 Article 79d Article 102 Article 80 Article 103 Article 81 Article 104 Article 82 Article 105 Article 82a Article 106 Article 83 Article 107 Article 84 Article 108 Article 85(1) Article 109(1) Article 85(1a) Article 109(2) Article 85(2) Article 109(3) Article 85(3) Article 109(4) Article 85(4) Article 109(5) Article 85(5) Article 109(6) Article 85(6) Article 109(7) Article 85(7) Article 109(8) Article 86 Article 110 Article 87 Article 111 Article 87a Article 112 Article 87b Article 113 Article 88 Article 114 Article 88a Article 115 Article 89 Article 116 Article 90 Article 117 Article 91 Article 118 Article 92 Article 119 Article 93 Article 120 Article 93a Article 121 Article 94 Article 122 Article 95(1) Article 123(1) Article 95(2) \u2014 Article 95(3) Article 123(2) Article 95(4) Article 123(3) Article 95(5) \u2014 Article 96 Article 124 Article 97 Article 125 Article 98 Article 126 Article 99 Article 127 Article 100 Article 128 Article 101 Article 129 Article 102 Article 130 Article 103 Article 131 Article 104 Article 132 Article 105 Article 133 Article 106 Article 134 Article 107 Article 135 Article 109 Article 136 Article 110 Article 137 Article 111 Article 138 Article 112 Article 139 Article 113 Article 140 Article 114 Article 141 Article 115 Article 142 Article 116 Article 143 Article 117 Article 144 Article 118 Article 145 Article 119(1) to (5) Article 146(1) to (5) Article 119(5a) Article 146(6) Article 119(6) Article 146(7) Article 119(7) Article 146(8) Article 119(8) Article 146(9) Article 119(9) Article 146(10) Article 119(10) Article 146(11) Article 120 Article 147 Article 121 Article 148 Article 123 Article 149 Article 123a Article 150 Article 123b Article 151 Article 123c Article 152 Article 124 Article 153 Article 125 Article 154 Article 126 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Article 196 Article 157 Article 197 Article 158 Article 198 Article 158a Article 199 Article 158b Article 200 Article 158c Article 201 Article 159 Article 202 Article 160 Article 203 Article 161 Article 204 Article 161a Article 205 Article 161b Article 206 Article 163 Article 207 Article 163a(1) Article 208(1) Article 163a(2), first sentence Article 208(2) Article 163a(2), second sentence Article 208(4) Article 163a(3) Article 208(3) Article 163a(4) Article 208(5) Article 163a(5) Article 208(6) Article 165 Article 209 Article 165a Article 210 Article 166 Article 211 Article 167 Article 212 Annex -I Annex I Annex I Annex II Annex II Annex III", "summary": "European Union trade mark European Union trade mark SUMMARY OF: Regulation (EU) 2017/1001 on the European Union trade mark WHAT IS THE AIM OF THE REGULATION? It establishes EU-wide rules and conditions for the granting of an EU trade mark. It codifies and replaces Council Regulation (EC) No 207/2009 and its numerous successive amendments. KEY POINTS EU trade mark Any person or company, including authorities established under public law, may obtain an EU trade mark through registration. It may consist of any signs, in particular words (including personal names), designs, letters, numerals and the shape of goods or of their packaging, provided that such signs are capable of: distinguishing the goods or services of one business from those of another; and being represented on the register of trade marks in such a way that the public and the authorities know exactly the subject matter that is being protected. Owner\u2019s rights It grants the owner exclusive rights, which prohibit third parties from using any of the following for commercial purposes: any sign which is identical with the EU trade mark in relation to goods or services which are identical with those for which the EU trade mark is registered; any sign where there is a likelihood of confusion with another trade mark; any sign which is identical with, or similar to, the EU trade mark in relation to goods or services which are not similar to those for which the EU trade mark is registered, where use of that sign takes advantage of the reputation and distinctive character of the trade mark. However, the owner of the EU trade mark may not prohibit third parties from using the following for commercial purposes: the owner\u2019s own name or address; indications concerning characteristics of goods or services such as the kind, quality or quantity; the trade mark where it is necessary to indicate the intended purpose of a product or service, as accessories or spare parts. Application Applicants must file an application for an EU trade mark with the European Union Intellectual Property Office (EUIPO). The application must contain the following information: a request for the registration of a EU trade mark, information identifying the applicant, a list of the goods or services in respect of which the registration is requested, a representation of the trade mark. Applicants must also pay an application fee. The application fee must be paid within 1 month of the filing date \u2014 the date on which the documents are filed with the EUIPO. Registration Once the application has been filed, EUIPO will examine whether it meets all the conditions for the granting of an EU trade mark. Publication of the application will allow third parties opposed to the granting of the trade mark to do so, on the basis of earlier rights, in opposition proceedings. If the application meets all the required criteria and no opposition is either entered or accepted, then the trade mark registration is published. Duration and renewal EU trade marks are registered for a period of 10 years from the date of filing of the application. Registration may be renewed for further periods of 10 years. The renewal application must be filed 6 months before the end of the validity of the registration. Surrender, revocation and invalidity An EU trade mark may be surrendered in respect of some or all of the goods or services for which it is registered. The rights of the owner may also be revoked if: the trade mark has not been subject to genuine use* in the EU for 5 years; the trade mark has become the common name for a product or service; the trade mark could deceive the public as to the nature, quality or geographical origin of the goods or services. The regulation also establishes grounds for invalidity of the trade mark. These grounds include, for example, cases where the applicant acted in bad faith when filing the application for the trade mark. EU collective marksWhen an application for registration is filed, it is possible to designate an EU trade mark as being collective. The following are authorised to file EU collective marks \u2014 associations of: manufacturers producers suppliers of services traders legal persons governed by public law. EU certification marksIt is also possible to designate an EU trade mark as a certification mark. The owner of such a mark certifies the material, mode of manufacture of goods or performance of services, quality, accuracy or other characteristics (excluding geographical origin) of the certified goods and services. Legal action Regulation (EU) No 1215/2012 applies to proceedings relating to EU trade marks and applications for EU trade marks, as well as to simultaneous and successive actions on the basis of EU and national trade marks.EU countries must designate \u2018EU trade mark courts\u2019. These courts have exclusive jurisdiction in all disputes concerning the infringement and validity of EU trade marks. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 October 2017. BACKGROUND EUIPO replaces the Office for Harmonization in the Internal Market from 23 March 2016 in line with Regulation (EU) 2015/2424 which amended Regulation (EC) No 207/2009 both of which were replaced by Regulation (EU) 2017/1001 . For more information, see: EUIPO \u2014 trade marks. KEY TERMS Genuine use: if a company registers an EU trade mark, uses it for a period and then stops using it for a continuous period of 5 years, the trade mark may be revoked. This is because there is no value in giving protection to trade marks if they are not being used and there is no interest in preventing another company, that might legitimately wish to use the mark, from using it. MAIN DOCUMENT Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, pp. 1-99) last update 13.02.2018"}
{"article": "20.9.2017 EN Official Journal of the European Union L 242/1 REGULATION (EU) 2017/1563 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 September 2017 on the cross-border exchange between the Union and third countries of accessible format copies of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled (the \u2018Marrakesh Treaty\u2019) was signed on behalf of the Union on 30 April 2014 (3). It requires contracting parties to provide for exceptions or limitations to copyright and related rights for the making and dissemination of copies, in accessible formats, of certain works and other protected subject matter, and for the cross-border exchange of those copies. (2) The beneficiaries of the Marrakesh Treaty are persons who are blind, persons who have a visual impairment which cannot be improved so as to give them visual function substantially equivalent to that of a person who has no such impairment, persons who have a perceptual or reading disability, including dyslexia or any other learning disability preventing them from reading printed works to substantially the same degree as persons without such disability, and persons who are unable, due to a physical disability, to hold or manipulate a book or to focus or move the eyes to the extent that would be normally acceptable for reading, insofar as, as a result of such impairments or disabilities, those persons are unable to read printed works to substantially the same degree as persons without such impairments or disabilities. (3) Persons who are blind, visually impaired or otherwise print-disabled continue to face many barriers to accessing books and other printed material which are protected by copyright and related rights. The need to increase the number of works and other protected subject matter in accessible formats available to such persons, and to significantly improve the circulation and dissemination of such works and other protected subject matter has been recognised at international level. (4) According to Opinion 3/15 of the Court of Justice of the European Union (4), the exceptions or limitations to copyright and related rights for the making and dissemination of copies, in accessible formats, of certain works and other subject matter, provided for by the Marrakesh Treaty, have to be implemented within the field harmonised by Directive 2001/29/EC of the European Parliament and of the Council (5). The same is true of the export and import arrangements prescribed by that treaty, inasmuch as they are ultimately intended to permit the communication to the public or the distribution, in the territory of a party, of accessible format copies published in the territory of another party, without the consent of the rightholders being obtained. (5) Directive (EU) 2017/1564 of the European Parliament and of the Council (6) aims to implement the obligations that the Union has to meet under the Marrakesh Treaty in a harmonised manner in order to improve the availability of accessible format copies for beneficiary persons in all of the Member States of the Union and the circulation of such copies within the internal market, and requires Member States to introduce a mandatory exception to certain rights that are harmonised by Union law. This Regulation aims to implement the obligations under the Marrakesh Treaty with respect to the export and import arrangements for accessible format copies for non-commercial purposes for the benefit of beneficiary persons between the Union and third countries that are parties to the Marrakesh Treaty, and to lay down the conditions for such export and import in a uniform manner within the field harmonised by Directives 2001/29/EC and (EU) 2017/1564 in order to ensure that those measures are applied consistently throughout the internal market and do not jeopardise the harmonisation of exclusive rights and exceptions contained within those Directives. (6) This Regulation should ensure that accessible format copies of books, including e-books, journals, newspapers, magazines and other kinds of writing, notation, including sheet music, and other printed material, including in audio form, whether digital or analogue, which have been made in any Member State in accordance with the national provisions adopted pursuant to Directive (EU) 2017/1564 can be distributed, communicated, or made available, to a beneficiary person or authorised entity, as referred to in the Marrakesh Treaty, in third countries that are parties to the Marrakesh Treaty. Accessible formats include, for example, Braille, large print, adapted e-books, audio books and radio broadcasts. Taking into account the \u2018non-commercial objective of the Marrakesh Treaty\u2019 (7), the distribution, communication to the public or making available to the public of accessible format copies to persons who are blind, visually impaired or otherwise print-disabled or to authorised entities in the third country should only be carried out on a non-profit basis by authorised entities established in a Member State. (7) This Regulation should also allow for the importation of, and access to, accessible format copies made in accordance with the implementation of the Marrakesh Treaty, from a third country, by beneficiary persons in the Union and authorised entities established in a Member State, for non-commercial purposes for the benefit of persons who are blind, visually impaired or otherwise print-disabled. It should be possible for those accessible format copies to circulate in the internal market under the same conditions as accessible format copies made in the Union in accordance with Directive (EU) 2017/1564. (8) In order to improve the availability of accessible format copies and to prevent the unauthorised dissemination of works or other subject matter, authorised entities which engage in the distribution, communication to the public or making available to the public of accessible format copies should comply with certain obligations. Initiatives by Member States to promote the objectives of the Marrakesh Treaty and the exchange of accessible format copies with third countries that are parties to that treaty, and to support authorised entities to exchange and make information available, should be encouraged. Such initiatives could include the development of guidelines or best practices on the making and dissemination of accessible format copies in consultation with representatives of authorised entities, beneficiary persons and rightholders. (9) It is essential that any processing of personal data under this Regulation respect fundamental rights, including the right to respect for private and family life and the right to protection of personal data under Articles 7 and 8 of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019), and it is imperative that any such processing also be in compliance with Directives 95/46/EC (8) and 2002/58/EC (9) of the European Parliament and of the Council, which govern the processing of personal data, as may be carried out by authorised entities within the framework of this Regulation and under the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States. (10) The United Nations Convention on the Rights of Persons with Disabilities (the \u2018UNCRPD\u2019), to which the Union is a party, guarantees persons with disabilities the right of access to information and education and the right to participate in cultural, economic and social life, on an equal basis with others. The UNCRPD requires parties to the Convention to take all appropriate steps, in accordance with international law, to ensure that laws protecting intellectual property rights do not constitute an unreasonable or discriminatory barrier to access by persons with disabilities to cultural materials. (11) Under the Charter, all forms of discrimination, including on grounds of disability, are prohibited and the right of persons with disabilities to benefit from measures designed to ensure their independence, social and occupational integration and participation in the life of the community is recognised and respected by the Union. (12) Since the objective of this Regulation, namely to implement in a uniform manner the obligations under the Marrakesh Treaty with respect to the export and import between the Union and third countries that are parties to the Marrakesh Treaty of accessible format copies of certain works and other subject matter for non-commercial purposes for the benefit of beneficiary persons, and to lay down the conditions for such export and import, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (13) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and the UNCRPD. This Regulation should be interpreted and applied in accordance with those rights and principles, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope This Regulation lays down uniform rules on the cross-border exchange of accessible format copies of certain works and other subject matter between the Union and third countries that are parties to the Marrakesh Treaty without the authorisation of the rightholder, for the benefit of persons who are blind, visually impaired or otherwise print-disabled, within the field harmonised by Directives 2001/29/EC and (EU) 2017/1564, in order to prevent jeopardising the harmonisation of exclusive rights and exceptions in the internal market. Article 2 Definitions For the purposes of this Regulation the following definitions apply: (1) \u2018work or other subject matter\u2019 means a work in the form of a book, journal, newspaper, magazine or other kind of writing, notation, including sheet music, and related illustrations, in any media, including in audio form such as audiobooks and in digital format, which is protected by copyright or related rights and which is published or otherwise lawfully made publicly available; (2) \u2018beneficiary person\u2019 means, regardless of any other disabilities, a person who: (a) is blind; (b) has a visual impairment which cannot be improved so as to give the person visual function substantially equivalent to that of a person who has no such impairment, and who is, as a result, unable to read printed works to substantially the same degree as a person without such an impairment; (c) has a perceptual or reading disability and is, as a result, unable to read printed works to substantially the same degree as a person without such disability; or (d) is otherwise unable, due to a physical disability, to hold or manipulate a book or to focus or move their eyes to the extent that would be normally acceptable for reading; (3) \u2018accessible format copy\u2019 means a copy of a work or other subject matter in an alternative manner or form that gives a beneficiary person access to the work or other subject matter, including allowing such person to have access as feasibly and comfortably as a person without any of the impairments or disabilities referred to in point 2; (4) \u2018authorised entity established in a Member State\u2019 means an entity that is authorised or recognised by a Member State to provide education, instructional training, adaptive reading or information access to beneficiary persons on a non-profit basis. It also includes a public institution or non-profit organisation that provides the same services to beneficiary persons as one of its primary activities, institutional obligations or as part of its public-interest missions. Article 3 Export of accessible format copies to third countries An authorised entity established in a Member State may distribute, communicate or make available to beneficiary persons or to an authorised entity established in a third country that is a party to the Marrakesh Treaty an accessible format copy of a work or other subject matter made in accordance with the national legislation adopted pursuant to Directive (EU) 2017/1564. Article 4 Import of accessible format copies from third countries A beneficiary person or an authorised entity established in a Member State may import or otherwise obtain or access and thereafter use, in accordance with the national legislation adopted pursuant to Directive (EU) 2017/1564, an accessible format copy of a work or other subject matter that has been distributed, communicated or made available to beneficiary persons or to authorised entities, by an authorised entity in a third country that is a party to the Marrakesh Treaty. Article 5 Obligations of authorised entities 1. An authorised entity established in a Member State carrying out the acts referred to in Articles 3 and 4 shall establish and follow its own practices to ensure that it: (a) distributes, communicates and makes available accessible format copies only to beneficiary persons or other authorised entities; (b) takes appropriate steps to discourage the unauthorised reproduction, distribution, communication to the public and making available to the public of accessible format copies; (c) demonstrates due care in, and maintains records of, its handling of works or other subject matter and of accessible format copies thereof; and (d) publishes and updates, on its website if appropriate, or through other online or offline channels, information on how it complies with the obligations laid down in points (a) to (c). An authorised entity established in a Member State shall establish and follow the practices referred to in the first subparagraph in full respect of the rules applicable to the processing of personal data of beneficiary persons referred to in Article 6. 2. An authorised entity established in a Member State carrying out the acts referred to in Articles 3 and 4 shall provide the following information in an accessible way, on request, to beneficiary persons, other authorised entities or rightholders: (a) the list of works or other subject matter for which it has accessible format copies and the available formats; and (b) the name and contact details of the authorised entities with which it has engaged in the exchange of accessible format copies pursuant to Articles 3 and 4. Article 6 Protection of personal data The processing of personal data carried out within the framework of this Regulation shall be carried out in compliance with Directives 95/46/EC and 2002/58/EC. Article 7 Review By 11 October 2023, the Commission shall carry out an evaluation of this Regulation and present the main findings in a report to the European Parliament, the Council and the European Economic and Social Committee, accompanied, where appropriate, by proposals for amending this Regulation. Member States shall provide the Commission with the necessary information for the preparation of the evaluation report. Article 8 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 12 October 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 13 September 2017. For the European Parliament The President A. TAJANI For the Council The President M. MAASIKAS (1) Opinion of 5 July 2017 (not yet published in the Official Journal). (2) Position of the European Parliament of 6 July 2017 (not yet published in the Official Journal) and decision of the Council of 17 July 2017. (3) Council Decision 2014/221/EU of 14 April 2014 on the signing, on behalf of the European Union, of the Marrakesh Treaty to Facilitate Access to Published Works for Persons who are Blind, Visually Impaired, or otherwise Print Disabled (OJ L 115, 17.4.2014, p. 1). (4) Opinion of the Court of Justice of 14 February 2017, 3/15, ECLI:EU:C:2017:114, paragraph 112. (5) Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p. 10). (6) Directive (EU) 2017/1564 of the European Parliament and of the Council of 13 September 2017 on certain permitted uses of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled and amending Directive 2001/29/EC on the harmonisation of certain aspects of copyright and related rights in the information society (see page 6 of this Official Journal). (7) Opinion of the Court of Justice of 14 February 2017, 3/15, ECLI:EU:C:2017:114, paragraph 90. (8) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). That Directive will be repealed and replaced, with effect from 25 May 2018, by Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (9) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).", "summary": "Regulation implementing the Marrakesh Treaty in the EU Regulation implementing the Marrakesh Treaty in the EU SUMMARY OF: Regulation (EU) 2017/1563 on the cross-border exchange between EU and non-EU countries of accessible format copies of certain works for the benefit of persons who are blind, visually impaired or otherwise print-disabled WHAT IS THE AIM OF THE REGULATION? It sets out the rules for how works or other subject matter* in accessible format copies* are shared between the EU and non-EU countries that are party to the Marrakesh Treaty, for the benefit of persons who are blind, visually impaired or otherwise print-disabled, and without needing copyright holder permission. KEY POINTS The Marrakesh Treaty The Marrakesh Treaty requires countries who sign up to it to adopt national laws encouraging books to be produced in accessible formats, such as braille, e-text, audio or large print, aimed at people who are blind, visually impaired or otherwise print-disabled. These laws should also make it easier to share these items across national boundaries without needing authorisation by the copyright holder. The treaty was signed in 2013 and was ratified by the EU on 1 October 2018. The EU became a party to the treaty on 1 January 2019. This regulation An EU country authorised entity* is permitted to make available to beneficiary persons*, or to any authorised entities in non-EU countries which are party to the treaty, accessible versions of books or other written materials allowed by Directive (EU) 2017/1564, the directive implementing the Marrakesh Treaty in the EU, and these items may also be imported and used by such persons or entities. An authorised entity must: discourage unauthorised reproduction and distribution to the public of accessible format copies; keep records of its handling of works and accessible format copies; publish information on how it complies with these obligations; follow rules on the processing of personal data of beneficiary persons; provide the following information in an accessible way, on request, to beneficiary persons, other authorised entities or copyright holders the list of works for which it has accessible format copies and the available formats andcontact details of the authorised entities involved in the exchange of accessible format copies. Review By 11 October 2023, the European Commission will evaluate the regulations\u2019s operation and report to the European Parliament, the Council and the European Economic and Social Committee, with proposals for amending the regulation, where appropriate. FROM WHEN DOES THE REGULATION APPLY? It has applied since 12 October 2018. BACKGROUND For more information, see: Implementation of the Marrakesh Treaty in EU law (European Commission) EU accedes to the Marrakesh Treaty (European External Action Service). KEY TERMS Work or other subject matter: a book, journal, newspaper, magazine or other kind of writing, notation, including sheet music, and related illustrations, in any media, including in audio form such as audiobooks and in digital format, which is protected by copyright or related rights and which is published or made publicly available. Accessible format copy: a copy of a work in a form that gives a beneficiary person access as feasibly and comfortably as a person without any of the impairments or disabilities covered by this regulation. Authorised entity: an entity authorised or recognised by a country to provide education, training, adaptive reading or information access to beneficiary persons on a non-profit basis. Beneficiary person: a person who is blind, has a visual impairment, or a perceptual or reading disability and is unable to read printed works to the same degree as a person without such an impairment, or is unable to hold or manipulate a book or to focus or move their eyes to the extent normally acceptable for reading. MAIN DOCUMENT Regulation (EU) 2017/1563 of the European Parliament and of the Council of 13 September 2017 on the cross-border exchange between the Union and third countries of accessible format copies of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled (OJ L 242, 20.9.2017, pp. 1-5) RELATED DOCUMENTS Council Decision (EU) 2018/254 of 15 February 2018 on the conclusion on behalf of the European Union of the Marrakesh Treaty to Facilitate Access to Published Works for Persons who are Blind, Visually Impaired, or otherwise Print Disabled (OJ L 48, 21.2.2018, pp. 1-2) Marrakesh Treaty to Facilitate Access to Published Works for Persons who are Blind, Visually Impaired, or otherwise Print Disabled (OJ L 48, 21.2.2018, pp. 3-11) Directive (EU) 2017/1564 of the European Parliament and of the Council of 13 September 2017 on certain permitted uses of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled and amending Directive 2001/29/EC on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 242, 20.9.2017, pp. 6-13) Council Decision 2014/221/EU of 14 April 2014 on the signing, on behalf of the European Union, of the Marrakesh Treaty to Facilitate Access to Published Works for Persons who are Blind, Visually Impaired, or otherwise Print Disabled (OJ L 115, 17.4.2014, p. 1-2) last update 21.03.2019"}
{"article": "27.12.2017 EN Official Journal of the European Union L 345/1 REGULATION (EU) 2017/2394 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Regulation (EC) No 2006/2004 of the European Parliament and of the Council (3) provides for harmonised rules and procedures to facilitate cooperation between the national authorities that are responsible for the enforcement of cross-border consumer protection laws. Article 21a of Regulation (EC) No 2006/2004 provides for a review of the effectiveness of that Regulation and its operational mechanisms. Following such review, the Commission concluded that Regulation (EC) No 2006/2004 is not sufficient to effectively address the enforcement challenges of the Single Market, including the challenges of the Digital Single Market. (2) The communication of the Commission of 6 May 2015, \u2018A Digital Single Market Strategy for Europe\u2019, identified as one of the priorities of that strategy, the need to enhance consumer trust through more rapid, agile and consistent enforcement of consumer rules. The communication of the Commission of 28 October 2015\u2018Upgrading the Single Market Strategy: more opportunities for people and business\u2019 reiterated that the enforcement of Union consumer protection legislation should be further strengthened by the reform of Regulation (EC) No 2006/2004. (3) The ineffective enforcement in cases of cross-border infringements, including infringements in the digital environment, enables traders to evade enforcement by relocating within the Union. It also gives rise to a distortion of competition for law-abiding traders operating either domestically or cross-border, online or offline, and thus directly harms consumers and undermines consumer confidence in cross-border transactions and the internal market. An increased level of harmonisation that includes effective and efficient enforcement cooperation among competent public enforcement authorities is therefore necessary to detect, to investigate and to order the cessation or prohibition of infringements covered by this Regulation. (4) Regulation (EC) No 2006/2004 established a network of competent public enforcement authorities throughout the Union. Effective coordination among different competent authorities participating in that network is necessary, as well as effective coordination among other public authorities at the Member State level. The coordination role of the single liaison office should be entrusted to a public authority in each Member State. That authority should have sufficient powers and necessary resources to undertake that key role. Each Member State is encouraged to designate one of the competent authorities as the single liaison office pursuant to this Regulation. (5) Consumers should also be protected against infringements covered by this Regulation that have already ceased, but the harmful effects of which may continue. Competent authorities should have the necessary minimum powers to investigate and to order the cessation of such infringements or their prohibition in the future, in order to prevent them from being repeated, and in so doing, to ensure a high level of consumer protection. (6) Competent authorities should have a minimum set of investigation and enforcement powers in order to apply this Regulation, to cooperate with each other more quickly and more efficiently and to deter traders from committing infringements covered by this Regulation. Those powers should be sufficient to tackle the enforcement challenges of e-commerce and the digital environment effectively and to prevent non-compliant traders from exploiting gaps in the enforcement system by relocating to Member States whose competent authorities are not equipped to tackle unlawful practices. Those powers should enable Member States to ensure that necessary information and evidence can be validly exchanged among competent authorities to achieve an equal level of effective enforcement in all Member States. (7) Each Member State should ensure that all competent authorities within its jurisdiction have all the minimum powers that are necessary to ensure the proper application of this Regulation. However, Member States should be able to decide not to confer all the powers on every competent authority, provided that each of those powers can be exercised effectively and as necessary in relation to any infringement covered by this Regulation. Member States should also be able to decide, in accordance with this Regulation, to ascribe certain tasks to designated bodies or to confer on competent authorities the power to consult consumer organisations, trader associations, designated bodies, or other persons concerned, regarding the effectiveness of the commitments proposed by a trader to cease the infringement covered by this Regulation. However, Member States should not be under any obligation to involve designated bodies in the application of this Regulation or to provide for consultations with consumer organisations, trader associations, designated bodies, or other persons concerned, regarding the effectiveness of the proposed commitments to cease the infringement covered by this Regulation. (8) Competent authorities should be in a position to open investigations or proceedings on their own initiative if they become aware of infringements covered by this Regulation by means other than consumer complaints. (9) Competent authorities should have access to any relevant documents, data and information that relate to the subject matter of an investigation or concerted investigations of a consumer market (\u2018sweeps\u2019) in order to determine whether an infringement of Union laws that protect consumers\u2019 interests has occurred or is occurring, and in particular to identify the trader responsible, irrespective of who possesses the documents, data or information in question, and regardless of their form or format, their storage medium, or the place where they are stored. Competent authorities should be able to directly request that third parties in the digital value chain provide any relevant evidence, data and information in accordance with Directive 2000/31/EC of the European Parliament and of the Council (4) and in accordance with the legislation on personal data protection. (10) Competent authorities should be able to request any relevant information from any public authority, body or agency within their Member State, or from any natural person or legal person, including, for example, payment service providers, internet service providers, telecommunication operators, domain registries and registrars, and hosting service providers, for the purpose of establishing whether an infringement covered by this Regulation has occurred or is occurring. (11) Competent authorities should be able to carry out necessary on-site inspections, and should have the power to enter any premises, land or means of transport, that the trader concerned by the inspection uses for purposes related to his trade, business, craft or profession. (12) Competent authorities should be able to request any representative or member of the staff of the trader concerned by the inspection to give explanations of facts, information, data or documents relating to the subject matter of the inspection, and should be able to record the answers given by that representative or staff member. (13) Competent authorities should be able to verify compliance with Union laws that protect consumers\u2019 interests and to obtain evidence of infringements covered by this Regulation, including infringements that take place during or after the purchase of goods or services. Competent authorities should therefore have the power to purchase goods or services as test purchases, where necessary, under a cover identity, in order to detect infringements covered by this Regulation, such as refusals to implement the consumer right of withdrawal in the case of distance contracts, and to obtain evidence. That power should also include the power to inspect, observe, study, disassemble or test a product or service that has been purchased by the competent authority for those purposes. The power to purchase goods or services as test purchases might include the power on the part of competent authorities to ensure the return of any payment made where such return would not be disproportionate and would otherwise comply with Union and national law. (14) In the digital environment in particular, the competent authorities should be able to stop infringements covered by this Regulation quickly and effectively, and in particular where the trader selling goods or services conceals his identity or relocates within the Union or to a third country in order to avoid enforcement. In cases where there is a risk of serious harm to the collective interests of consumers, the competent authorities should be able to adopt interim measures in accordance with national law, including the removal of content from an online interface or ordering the explicit display of a warning to consumers when they access an online interface. Interim measures should not go beyond what is necessary to achieve their objective. Furthermore, the competent authorities should have the power to order the explicit display of a warning to consumers when they access an online interface, or to order the removal or modification of digital content if there are no other effective means to stop an illegal practice. Such measures should not go beyond what is necessary to achieve the objective of bringing to an end or prohibiting the infringement covered by this Regulation. (15) Pursuing the objective of this Regulation while stressing the importance of the traders\u2019 willingness to act in accordance with Union laws that protect consumers\u2019 interests and to remedy the consequences of their infringements covered by this Regulation, competent authorities should have the possibility to agree with traders on commitments containing steps and measures that a trader has to take regarding an infringement, and in particular the ceasing of an infringement. (16) Because they have a direct impact on the degree to which public enforcement acts as a deterrent, penalties for infringements of consumer law represent an important part of the enforcement system. Since national penalties regimes do not always allow the cross-border dimension of an infringement to be taken into account, competent authorities should, as part of their minimum powers, have the right to impose penalties for infringements covered by this Regulation. Member States should not be required to establish a new penalty regime for infringements covered by this Regulation. Instead, they should require competent authorities to apply the applicable regime for the same domestic infringement, where possible taking into account the actual scale and scope of the infringement concerned. In view of the findings of the Commission\u2019s Report of the Fitness Check of consumer and marketing law, it might be considered to be necessary to strengthen the level of penalties for breaches of Union consumer law. (17) Consumers should be entitled to redress for harm caused by infringements covered by this Regulation. Depending on the case, the power of the competent authorities to receive from the trader, on the trader\u2019s initiative, additional remedial commitments for the benefit of consumers that have been affected by the alleged infringement covered by this Regulation, or where appropriate to seek to obtain commitments from the trader to offer adequate remedies to the consumers that have been affected by that infringement should contribute to removing the adverse impact on consumers caused by a cross-border infringement. Those remedies might include, inter alia, repair, replacement, price reductions, the termination of contract or the reimbursement of the price paid for the goods or services, as appropriate, to mitigate the negative consequences of the infringement covered by this Regulation on the affected consumer in accordance with the requirements of Union law. This should be without prejudice to a consumer\u2019s right to seek redress through appropriate means. Where applicable, competent authorities should inform, by appropriate means, consumers that claim that they have suffered harm as a consequence of an infringement covered by this Regulation about how to seek compensation under national law. (18) The implementation and exercise of powers in application of this Regulation should be proportionate and adequate in view of the nature and the overall actual or potential harm of the infringement of Union laws that protect consumers\u2019 interests. Competent authorities should take all facts and circumstances of the case into account and should choose the most appropriate measures which are essential to address the infringement covered by this Regulation. Those measures should be proportionate, effective and dissuasive. (19) The implementation and exercise of powers in the application of this Regulation should also comply with other Union and national law, including with applicable procedural safeguards and principles of the fundamental rights. Member States should remain free to set out conditions and limits for the exercise of the powers in national law, in accordance with Union law. Where, for example, in accordance with national law, prior authorisation to enter the premises of natural persons and legal persons is required from the judicial authority of the Member State concerned, the power to enter such premises should be used only after such prior authorisation has been obtained. (20) Member States should be able to choose whether the competent authorities exercise those powers directly, under their own authority, by recourse to other competent authorities or other public authorities, by instructing designated bodies or by application to the competent courts. Member States should ensure that those powers are exercised effectively and in a timely manner. (21) When responding to requests submitted through the mutual assistance mechanism, competent authorities should, where appropriate, also make use of other powers or measures granted to them at the national level, including the power to initiate or refer matters for criminal prosecution. It is of the utmost importance that courts and other authorities, in particular those involved in criminal prosecution, have the necessary means and powers to cooperate with competent authorities effectively and in a timely manner. (22) The effectiveness and efficiency of the mutual assistance mechanism should be improved. Requested information should be provided within the time limits set out in this Regulation, and necessary investigation and enforcement measures should be adopted in a timely manner. Competent authorities should reply to information and enforcement requests within set periods, unless otherwise agreed. The obligations of the competent authority within the mutual assistance mechanism should remain intact, unless it is likely that enforcement actions and administrative decisions taken at national level outside the mutual assistance mechanism would ensure the swift and effective cessation or prohibition of the intra-Union infringement. Administrative decisions in that regard should be understood as decisions giving effect to the measures taken to bring about the cessation or the prohibition of the intra-Union infringement. In those exceptional cases, competent authorities should be entitled to refuse to comply with a request for enforcement measures submitted under the mutual assistance mechanism. (23) The Commission should be better able to coordinate and monitor the functioning of the mutual assistance mechanism, issue guidance, make recommendations and issue opinions to the Member States when problems arise. The Commission should also be better able to assist competent authorities effectively and quickly to resolve disputes over the interpretation of their obligations stemming from the mutual assistance mechanism. (24) This Regulation should provide for harmonised rules setting out the procedures for the coordination of investigation and enforcement measures relating to widespread infringements and widespread infringements with a Union dimension. Coordinated actions against widespread infringements and widespread infringements with a Union dimension should ensure that competent authorities are able to choose the most appropriate and efficient tools to stop those infringements and, where appropriate, to receive or seek to obtain from the traders responsible remedial commitments for the benefit of consumers. (25) As part of a coordinated action, the competent authorities concerned should coordinate their investigation and enforcement measures in order to tackle effectively the widespread infringement or widespread infringement with a Union dimension and to bring about its cessation or prohibition. To that end, all necessary evidence and information should be exchanged between the competent authorities and necessary assistance should be provided. Competent authorities concerned by the widespread infringement or widespread infringement with a Union dimension should take the necessary enforcement measures in a coordinated way in order to bring about the cessation or prohibition of that infringement. (26) The participation of each competent authority in a coordinated action, and in particular the investigation and enforcement measures that a competent authority is required to take should be sufficient in order to address the widespread infringement or widespread infringement with a Union dimension effectively. Competent authorities concerned by that infringement should be required to take only those investigation and enforcement measures which are needed to obtain all necessary evidence and information regarding the widespread infringement or widespread infringement with a Union dimension and to bring about the cessation or prohibition of the infringement. However, a lack of available resources on the part of the competent authority concerned by that infringement should not be considered to justify not taking part in a coordinated action. (27) Competent authorities concerned by the widespread infringement or widespread infringement with a Union dimension which participate in a coordinated action should be able to conduct national investigation and enforcement activities in relation to the same infringement and against the same trader. However, at the same time, the obligation of the competent authority to coordinate its investigation and enforcement activities in the framework of the coordinated action with other competent authorities concerned by that infringement should remain intact, unless it is likely that enforcement actions and administrative decisions taken at national level outside the framework of the coordinated action would ensure the swift and effective cessation or prohibition of the widespread infringement or widespread infringement with a Union dimension. Administrative decisions in that regard should be understood as decisions giving effect to the measures taken to bring about the cessation or the prohibition of the infringement. In those exceptional cases, competent authorities should be entitled to decline to participate in the coordinated action. (28) Where there is a reasonable suspicion of a widespread infringement, the competent authorities concerned by that infringement should, by agreement, launch a coordinated action. In order to establish which competent authorities are concerned by a widespread infringement, all relevant aspects of that infringement should be considered, and in particular the place where the trader is established or resides, the location of the trader\u2019s assets, the location of the consumers who were harmed by the alleged infringement, and the place of the points of sale of the trader, namely, shops and websites. (29) The Commission should cooperate more closely with Member States to prevent large-scale infringements from occurring. The Commission should therefore notify competent authorities if it suspects any infringements covered by this Regulation. If, for example by monitoring the alerts issued by competent authorities, the Commission has a reasonable suspicion that a widespread infringement with a Union dimension has occurred, it should notify Member States, through the competent authorities and single liaison offices concerned by that alleged infringement, stating the grounds which justify a possible coordinated action in the notification. Competent authorities concerned should conduct appropriate investigations on the basis of information that is available or easily accessible to them. They should notify the results of their investigations to the other competent authorities, to the single liaison offices concerned by that infringement and to the Commission. Where the competent authorities concerned conclude that such investigations reveal that an infringement might be taking place, they should start the coordinated action by taking the measures set out in this Regulation. A coordinated action tackling a widespread infringement with a Union dimension should always be coordinated by the Commission. If it is apparent that the Member State is concerned by that infringement, it should take part in a coordinated action in order to help to collect all necessary evidence and information related to the infringement and to bring about its cessation or prohibition. As regards the enforcement measures, criminal and judicial proceedings in Member States should not be affected by the application of this Regulation. The principle of ne bis in idem should be respected. However, if the same trader repeats the same act or omission that constituted an infringement covered by this Regulation which had already been addressed by enforcement proceedings that resulted in the cessation or prohibition of that infringement, it should be considered to be a new infringement and the competent authorities should address it. (30) Competent authorities concerned should take the necessary investigation measures to establish the details of the widespread infringement or widespread infringement with a Union dimension, and in particular the identity of the trader, acts or omissions committed by the trader, and the effects of the infringement. The competent authorities should take enforcement measures based on the outcome of the investigation. Where appropriate, the outcome of the investigation and the assessment of the widespread infringement or the widespread infringement with a Union dimension should be set out in a common position agreed among the competent authorities of the Member States concerned by the coordinated action, and should be addressed to the trader responsible for that infringement. The common position should not constitute a binding decision of the competent authorities. It should, however, give the addressee the opportunity to be heard on the matters which are part of the common position. (31) In the context of widespread infringements or widespread infringements with a Union dimension, the rights of defence of the traders should be respected. This requires, in particular, giving the trader the rights to be heard and to use, during the proceedings, the official language or one of the official languages used for official purposes in the Member State in which the trader is established or resides. It is also essential to ensure compliance with Union law on the protection of undisclosed know-how and business information. (32) Competent authorities concerned should take within their jurisdiction the necessary investigation and enforcement measures. However, the effects of widespread infringements or widespread infringements with a Union dimension are not limited to a single Member State. Therefore cooperation between competent authorities is required to address those infringements and to bring about their cessation or prohibition. (33) The effective detection of infringements covered by this Regulation should be supported by exchanging information between competent authorities and the Commission by the means of issuing alerts if there is a reasonable suspicion of such infringements. The Commission should coordinate the functioning of the exchange of information. (34) Consumer organisations play an essential role in informing consumers about their rights and educating them and protecting their interests, including the settlement of disputes. Consumers should be encouraged to cooperate with the competent authorities to strengthen the application of this Regulation. (35) Consumer organisations, and where appropriate trader associations, should be allowed to notify competent authorities of suspected infringements covered by this Regulation and to share with them the information needed to detect, investigate and stop infringements, to give their opinion about investigations or infringements and to notify competent authorities of abuses of Union laws that protect consumers\u2019 interests. (36) In order to ensure the correct implementation of this Regulation, Member States should confer on designated bodies, European Consumer Centres, consumer organisations and associations, and, where appropriate, trader associations, that have the necessary expertise, the power to issue external alerts to the competent authorities of the relevant Member States and the Commission of suspected infringements covered by this Regulation and to provide the necessary information available to them. Member States might have appropriate reasons for not conferring on such entities the power to undertake those actions. In this context, where a Member State decides not to allow one of those entities to issue external alerts, it should provide an explanation justifying its reasons for doing so. (37) Sweeps are another form of enforcement coordination that has proven to be an effective tool against infringements of Union laws that protect consumers\u2019 interests, and should be retained and strengthened in the future, for both online and offline sectors. In particular, sweeps should be conducted where market trends, consumer complaints or other indications suggest that infringements of Union laws that protect consumers\u2019 interests have occurred or are occurring. (38) Data related to consumer complaints might help policymakers at Union and national level to assess the functioning of consumer markets and to detect infringements. The exchange of such data at Union level should be promoted. (39) It is essential that, to the extent necessary to contribute to achieving the objective of this Regulation, Member States inform each other and the Commission about their activities in protecting consumers\u2019 interests, including about their support for the activities of consumer representatives, their support for the activities of bodies responsible for the extra-judicial settlement of consumer disputes and their support for consumers\u2019 access to justice. In cooperation with the Commission, Member States should be able to carry out joint activities with respect to the exchange of consumer policy information in the aforementioned areas. (40) The enforcement challenges that exist go beyond the frontiers of the Union, and the interests of Union consumers need to be protected from rogue traders based in third countries. Hence, international agreements with third countries regarding mutual assistance in the enforcement of Union laws that protect consumers\u2019 interests should be negotiated. Those international agreements should include the subject matter laid down in this Regulation and should be negotiated at Union level in order to ensure the optimum protection of Union consumers and smooth cooperation with third countries. (41) Information exchanged between competent authorities should be subject to strict rules on confidentiality and on professional and commercial secrecy, in order to ensure investigations are not compromised or that the reputations of traders are not unfairly harmed. Competent authorities should decide to disclose such information only when appropriate and necessary, in accordance with the principle of proportionality, taking into account the public interest, such as public safety, consumer protection, public health, environmental protection or proper conduct of criminal investigations, and on a case-by-case basis. (42) In order to enhance the transparency of the cooperation network, and to raise awareness amongst consumers and the public in general, every 2 years the Commission should produce an overview of the information, statistics and developments in the area of consumer law enforcement, collected within the enforcement framework of the cooperation provided for by this Regulation, and make it publicly available. (43) Widespread infringements should be resolved effectively and efficiently. A system of biennial exchange of enforcement priorities should be put in place to achieve this. (44) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission, to lay down the practical and operational arrangements for the functioning of the electronic database. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (5). (45) This Regulation is without prejudice to sectoral Union rules providing for cooperation among sectoral regulators or to applicable sectoral Union rules on the compensation of consumers for harm resulting from infringements of those rules. This Regulation is also without prejudice to other cooperation systems and networks set out in sectoral Union legislation. This Regulation promotes cooperation and coordination among the consumer protection network and the networks of regulatory bodies and authorities established by sectoral Union legislation. This Regulation is without prejudice to the application in the Member States of measures relating to judicial cooperation in civil and criminal matters. (46) This Regulation is without prejudice to the right to claim individual or collective compensation, which is subject to the national law, and does not provide for the enforcement of those claims. (47) Regulation (EC) No 45/2001 of the European Parliament and of the Council (6), Regulation (EU) 2016/679 of the European Parliament and of the Council (7) and Directive (EU) 2016/680 of the European Parliament and of the Council (8) should apply in the context of this Regulation. (48) This Regulation is without prejudice to the applicable Union rules concerning the powers of national regulatory bodies established by Union sectoral legislation. Where appropriate and possible, those bodies should use the powers available to them under Union law and national law to bring about the cessation or prohibition of infringements covered by this Regulation, and to assist the competent authorities in doing so. (49) This Regulation is without prejudice to the role and the powers of the competent authorities and of the European Banking Authority in relation to the protection of the collective economic interests of consumers in matters concerning payment accounts services and credit agreements relating to residential immovable property under Directive 2014/17/EU of the European Parliament and of the Council (9) and Directive 2014/92/EU of the European Parliament and of the Council (10). (50) In view of the existing cooperation mechanisms under Directive 2014/17/EU and Directive 2014/92/EU, the mutual assistance mechanism should not apply to intra-Union infringements of those Directives. (51) This Regulation is without prejudice to Council Regulation No 1 (11). (52) This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and present in the constitutional traditions of the Member States. Accordingly, this Regulation should be interpreted and applied in accordance with those rights and principles, including those related to the freedom of expression and the freedom and pluralism of the media. When exercising the minimum powers set out in this Regulation, the competent authorities should strike an appropriate balance between the interests protected by fundamental rights such as a high level of consumer protection, the freedom to conduct a business and the freedom of information. (53) Since the objective of this Regulation, namely, cooperation between national authorities responsible for the enforcement of consumer protection laws, cannot be sufficiently achieved by the Member States because they cannot ensure cooperation and coordination by acting alone, but can rather, by reason of its territorial and personal scope, be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (54) Regulation (EC) No 2006/2004 should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I INTRODUCTORY PROVISIONS Article 1 Subject matter This Regulation lays down the conditions under which competent authorities, having been designated by their Member States as responsible for the enforcement of Union laws that protect consumers\u2019 interests, cooperate and coordinate actions with each other and with the Commission, in order to enforce compliance with those laws and to ensure the smooth functioning of the internal market, and in order to enhance the protection of consumers\u2019 economic interests. Article 2 Scope 1. This Regulation applies to intra-Union infringements, widespread infringements and widespread infringements with a Union dimension, even if those infringements have ceased before enforcement starts or is completed. 2. This Regulation is without prejudice to the Union rules on private international law, in particular rules related to court jurisdiction and applicable laws. 3. This Regulation is without prejudice to the application in the Member States of measures relating to judicial cooperation in civil and criminal matters, in particular the operation of the European Judicial Network. 4. This Regulation is without prejudice to the fulfilment by the Member States of any additional obligations in relation to mutual assistance for the protection of the collective economic interests of consumers, including in criminal matters, stemming from other legal acts, including bilateral or multilateral agreements. 5. This Regulation is without prejudice to Directive 2009/22/EC of the European Parliament and of the Council (12). 6. This Regulation is without prejudice to the possibility of bringing further public or private enforcement actions under national law. 7. This Regulation is without prejudice to relevant Union law applicable to the protection of individuals with regard to the processing of personal data. 8. This Regulation is without prejudice to national law applicable to compensation of consumers for harm caused by infringements of Union laws that protect consumers\u2019 interests. 9. This Regulation is without prejudice to the right of the competent authorities to conduct investigation and enforcement actions against more than one trader for similar infringements covered by this Regulation. 10. Chapter III of this Regulation does not apply to intra-Union infringements of Directives 2014/17/EU and 2014/92/EU. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018Union laws that protect consumers\u2019 interests\u2019 means the Regulations and the Directives, as transposed into the internal legal order of the Member States, that are listed in the Annex hereto; (2) \u2018intra-Union infringement\u2019 means any act or omission contrary to Union laws that protect consumers\u2019 interests that has done, does or is likely to do harm to the collective interests of consumers residing in a Member State other than the Member State in which: (a) the act or omission originated or took place; (b) the trader responsible for the act or omission is established; or (c) evidence or assets of the trader pertaining to the act or omission are to be found; (3) \u2018widespread infringement\u2019 means: (a) any act or omission contrary to Union laws that protect consumers\u2019 interests that has done, does or is likely to do harm to the collective interests of consumers residing in at least two Member States other than the Member State in which: (i) the act or omission originated or took place; (ii) the trader responsible for the act or omission is established; or (iii) evidence or assets of the trader pertaining to the act or omission are to be found; or (b) any acts or omissions contrary to Union laws that protect consumers interests that have done, do or are likely to do harm to the collective interests of consumers and that have common features, including the same unlawful practice, the same interest being infringed and that are occurring concurrently, committed by the same trader, in at least three Member States; (4) \u2018widespread infringement with a Union dimension\u2019 means a widespread infringement that has done, does or is likely to do harm to the collective interests of consumers in at least two-thirds of the Member States, accounting, together, for at least two-thirds of the population of the Union; (5) \u2018infringements covered by this Regulation\u2019 means intra-Union infringements, widespread infringements and widespread infringements with a Union dimension; (6) \u2018competent authority\u2019 means any public authority established either at national, regional or local level and designated by a Member State as responsible for enforcing the Union laws that protect consumers\u2019 interests; (7) \u2018single liaison office\u2019 means the public authority designated by a Member State as responsible for coordinating the application of this Regulation within that Member State; (8) \u2018designated body\u2019 means a body having a legitimate interest in the cessation or prohibition of infringements of the Union laws that protect consumers\u2019 interests which is designated by a Member State and instructed by a competent authority for the purpose of gathering the necessary information and to take the necessary enforcement measures available to that body under national law in order to bring about the cessation or prohibition of the infringement, and which is acting on behalf of that competent authority; (9) \u2018applicant authority\u2019 means the competent authority that makes a request for mutual assistance; (10) \u2018requested authority\u2019 means the competent authority that receives a request for mutual assistance; (11) \u2018trader\u2019 means any natural person or any legal person, irrespective of whether privately or publicly owned, who is acting, including through any other person acting in his name or on his behalf, for purposes relating to his trade, business, craft or profession; (12) \u2018consumer\u2019 means any natural person who is acting for purposes which are outside his trade, business, craft or profession; (13) \u2018consumer complaint\u2019 means a statement, supported by reasonable evidence, that a trader has committed, is committing, or is likely to commit, an infringement of the Union laws that protect consumers\u2019 interests; (14) \u2018harm to collective interests of consumers\u2019 means actual or potential harm to the interests of a number of consumers that are affected by intra-Union infringements, by widespread infringements or by widespread infringements with a Union dimension; (15) \u2018online interface\u2019 means any software, including a website, part of a website or an application, that is operated by or on behalf of a trader, and which serves to give consumers access to the trader\u2019s goods or services; (16) \u2018sweeps\u2019 means concerted investigations of consumer markets through simultaneous coordinated control actions to check compliance with, or to detect infringements of, Union laws that protect consumers\u2019 interests. Article 4 Notification of limitation periods Each single liaison office shall notify the Commission of the limitation periods that are in place in its own Member State and that apply to enforcement measures referred to in Article 9(4). The Commission shall summarise the notified limitation periods and shall make that summary available to the competent authorities. CHAPTER II COMPETENT AUTHORITIES AND THEIR POWERS Article 5 Competent authorities and single liaison offices 1. Each Member State shall designate one or more competent authorities and the single liaison office that are responsible for the application of this Regulation. 2. Competent authorities shall fulfil their obligations under this Regulation as though acting on behalf of consumers in their own Member State and on their own account. 3. Within each Member State, the single liaison office shall be responsible for coordinating the investigation and enforcement activities of the competent authorities, other public authorities referred to in Article 6 and, if applicable, designated bodies, in relation to infringements covered by this Regulation. 4. Member States shall ensure that competent authorities and single liaison offices have the necessary resources for the application of this Regulation, including sufficient budgetary and other resources, expertise, procedures and other arrangements. 5. Where there is more than one competent authority in their territory, Member States shall ensure that the respective duties of those competent authorities are clearly defined and that they collaborate closely in order to discharge those duties effectively. Article 6 Cooperation for the application of this Regulation within Member States 1. For the purpose of the proper application of this Regulation each Member State shall ensure that its competent authorities, other public authorities and, if applicable, designated bodies cooperate effectively with one another. 2. Other public authorities referred to in paragraph 1 shall, at the request of a competent authority, take all necessary measures available to them under national law in order to bring about the cessation or prohibition of infringements covered by this Regulation. 3. The Member States shall ensure that the other public authorities referred to in paragraph 1 have the means and powers necessary to cooperate effectively with the competent authorities in the application of this Regulation. Those other public authorities shall regularly inform the competent authorities about the measures taken in the application of this Regulation. Article 7 Role of designated bodies 1. Where applicable, a competent authority (\u2018instructing authority\u2019) may, in accordance with its national law, instruct a designated body to gather the necessary information regarding an infringement covered by this Regulation or to take the necessary enforcement measures available to it under national law, in order to bring about the cessation or prohibition of that infringement. The instructing authority shall only instruct a designated body if, after consulting the applicant authority or the other competent authorities concerned by the infringement covered by this Regulation, both the applicant authority and requested authority, or all competent authorities concerned, agree that the designated body is likely to obtain the necessary information or to bring about the cessation or the prohibition of the infringement in a manner that is at least as efficient and effective as the instructing authority would have done. 2. If the applicant authority or the other competent authorities concerned by an infringement covered by this Regulation are of the view that the conditions set out in paragraph 1 have not been fulfilled, they shall inform the instructing authority in writing without delay, setting out the reasons justifying that view. If the instructing authority does not share that view, it may refer the matter to the Commission, which shall issue an opinion on the matter without delay. 3. The instructing authority shall continue to be obliged to gather the necessary information or to take the necessary enforcement measures if: (a) the designated body fails to obtain the necessary information or to bring about the cessation or prohibition of the infringement covered by this Regulation without delay; or (b) the competent authorities concerned by an infringement covered by this Regulation do not agree that the designated body may be instructed pursuant to paragraph 1. 4. The instructing authority shall take all necessary measures to prevent the disclosure of information which is subject to the rules on confidentiality and on professional and commercial secrecy laid down in Article 33. Article 8 Information and lists 1. Each Member State shall, without delay, communicate to the Commission the following information and any changes thereto: (a) the identities and contact details of the competent authorities, of the single liaison office, of the designated bodies and of the entities issuing external alerts pursuant to Article 27(1); and (b) information about the organisation, powers and responsibilities of the competent authorities. 2. The Commission shall maintain and update on its website a publicly available list of competent authorities, single liaison offices, designated bodies and entities issuing external alerts pursuant to Article 27(1) or (2). Article 9 Minimum powers of competent authorities 1. Each competent authority shall have the minimum investigation and enforcement powers set out in paragraphs 3, 4, 6 and 7 of this Article that are necessary for the application of this Regulation and shall exercise those powers in accordance with Article 10. 2. Notwithstanding paragraph 1, Member States may decide not to confer all the powers on every competent authority, provided that each of those powers can be exercised effectively and as necessary in relation to any infringement covered by this Regulation in accordance with Article 10. 3. Competent authorities shall have at least the following investigation powers: (a) the power of access to any relevant documents, data or information related to an infringement covered by this Regulation, in any form or format and irrespective of their storage medium, or the place where, they are stored; (b) the power to require any public authority, body or agency within their Member State or any natural person or legal person to provide any relevant information, data or documents, in any form or format and irrespective of their storage medium, or the place where they are stored, for the purposes of establishing whether an infringement covered by this Regulation has occurred or is occurring, and for the purposes of establishing the details of such infringement, including tracing financial and data flows, ascertaining the identity of persons involved in financial and data flows, and ascertaining bank account information and ownership of websites; (c) the power to carry out necessary on-site inspections, including the power to enter any premises, land or means of transport that the trader concerned by the inspection uses for purposes related to his trade, business, craft or profession, or to request other public authorities to do so, in order to examine, seise, take or obtain copies of information, data or documents, irrespective of their storage medium; the power to seise any information, data or documents for a necessary period and to the extent necessary for the inspection; the power to request any representative or member of the staff of the trader concerned by the inspection to give explanations of facts, information, data or documents relating to the subject matter of the inspection and to record the answers; (d) the power to purchase goods or services as test purchases, where necessary, under a cover identity, in order to detect infringements covered by this Regulation and to obtain evidence, including the power to inspect, observe, study, disassemble or test goods or services. 4. Competent authorities shall have at least the following enforcement powers: (a) the power to adopt interim measures to avoid the risk of serious harm to the collective interests of consumers; (b) the power to seek to obtain or to accept commitments from the trader responsible for the infringement covered by this Regulation to cease that infringement; (c) the power to receive from the trader, on the trader\u2019s initiative, additional remedial commitments for the benefit of consumers that have been affected by the alleged infringement covered by this Regulation, or, where appropriate, to seek to obtain commitments from the trader to offer adequate remedies to the consumers that have been affected by that infringement; (d) where applicable, the power to inform, by appropriate means, consumers that claim that they have suffered harm as a consequence of an infringement covered by this Regulation about how to seek compensation under national law; (e) the power to order in writing the cessation of infringements covered by this Regulation by the trader; (f) the power to bring about the cessation or the prohibition of infringements covered by this Regulation; (g) where no other effective means are available to bring about the cessation or the prohibition of the infringement covered by this Regulation and in order to avoid the risk of serious harm to the collective interests of consumers: (i) the power to remove content or to restrict access to an online interface or to order the explicit display of a warning to consumers when they access an online interface; (ii) the power to order a hosting service provider to remove, disable or restrict access to an online interface; or (iii) where appropriate, the power to order domain registries or registrars to delete a fully qualified domain name and to allow the competent authority concerned to register it; including by requesting a third party or other public authority to implement such measures; (h) the power to impose penalties, such as fines or periodic penalty payments, for infringements covered by this Regulation and for the failure to comply with any decision, order, interim measure, trader\u2019s commitment or other measure adopted pursuant to this Regulation. The penalties referred to in point (h) shall be effective, proportionate and dissuasive, in accordance with the requirements of Union laws that protect consumers\u2019 interests. In particular, due regard shall be given, as appropriate, to the nature, gravity and duration of the infringement in question. 5. The power to impose penalties, such as fines or periodic penalty payments, for infringements covered by this Regulation applies to any infringement of Union laws that protect consumers\u2019 interests, where the relevant Union legal act listed in the Annex provides for penalties. This is without prejudice to the power of national authorities under national law to impose penalties, such as administrative or other fines, or periodic penalty payments, in cases where the Union legal acts listed in the Annex do not provide for penalties. 6. Competent authorities shall have the power to start investigations or proceedings on their own initiative to bring about the cessation or prohibition of infringements covered by this Regulation. 7. Competent authorities may publish any final decision, trader\u2019s commitments or orders adopted pursuant to this Regulation, including the publication of the identity of the trader responsible for an infringement covered by this Regulation. 8. Where applicable, competent authorities may consult consumer organisations, trader associations, designated bodies or other persons concerned, regarding the effectiveness of the proposed commitments in bringing the infringement covered by this Regulation to an end. Article 10 Exercise of minimum powers 1. The powers set out in Article 9 shall be exercised either: (a) directly by competent authorities under their own authority; (b) where appropriate, by recourse to other competent authorities or other public authorities; (c) by instructing designated bodies, if applicable; or (d) by application to courts competent to grant the necessary decision, including, where appropriate, by appeal, if the application to grant the necessary decision is not successful. 2. The implementation and the exercise of powers set out in Article 9 in application of this Regulation shall be proportionate and shall comply with Union and national law, including with applicable procedural safeguards and with the principles of the Charter of Fundamental Rights of the European Union. The investigation and enforcement measures adopted in application of this Regulation shall be appropriate to the nature and the overall actual or potential harm of the infringement of Union laws that protect consumers\u2019 interests. CHAPTER III MUTUAL ASSISTANCE MECHANISM Article 11 Requests for information 1. At the request of an applicant authority, a requested authority shall, without delay, and in any event within 30 days unless otherwise agreed, provide to the applicant authority any relevant information necessary to establish whether an intra-Union infringement has occurred or is occurring, and to bring about the cessation of that infringement. 2. The requested authority shall undertake the appropriate and necessary investigations or take any other necessary or appropriate measures in order to gather the required information. If necessary, those investigations shall be carried out with the assistance of other public authorities or designated bodies. 3. On request from the applicant authority, the requested authority may allow officials of the applicant authority to accompany the officials of the requested authority in the course of their investigations. Article 12 Requests for enforcement measures 1. At the request of an applicant authority, a requested authority shall take all necessary and proportionate enforcement measures to bring about the cessation or prohibition of the intra-Union infringement by exercising the powers set out in Article 9 and any additional powers granted to it under national law. The requested authority shall determine the appropriate enforcement measures needed to bring about the cessation or prohibition of the intra-Union infringement and shall take them without delay and not later than 6 months after receiving the request, unless it provides specific reasons for extending that period. Where appropriate, the requested authority shall impose penalties, such as fines or periodic penalty payments, on the trader responsible for the intra-Union infringement. The requested authority may receive from the trader, on the trader\u2019s initiative, additional remedial commitments for the benefit of consumers that have been affected by the alleged intra-Union infringement, or, where appropriate, may seek to obtain commitments from the trader to offer adequate remedies to consumers that have been affected by that infringement. 2. The requested authority shall regularly inform the applicant authority about the steps and measures taken and the steps and measures that it intends to take. The requested authority shall use the electronic database provided for in Article 35 to notify without delay the applicant authority, the competent authorities of other Member States and the Commission of the measures taken and the effect of those measures on the intra-Union infringement, including the following: (a) whether interim measures have been imposed; (b) whether the infringement has ceased; (c) which measures have been adopted, and whether those measures have been implemented; (d) the extent to which consumers affected by the alleged infringement have been offered remedial commitments. Article 13 Procedure for requests for mutual assistance 1. When making a request for mutual assistance, the applicant authority shall provide the information necessary to enable the requested authority to fulfil that request, including any necessary evidence which can only be obtained in the Member State of the applicant authority. 2. The applicant authority shall send such requests for mutual assistance to the single liaison office of the Member State of the requested authority and to the single liaison office of the Member State of the applicant authority for information. The single liaison office of the Member State of the requested authority shall pass the requests on to the appropriate competent authority without delay. 3. Requests for mutual assistance and all communications linked to them shall be made in writing using standard forms and shall be communicated electronically via the electronic database provided for in Article 35. 4. The competent authorities concerned shall agree on the languages to be used for requests for mutual assistance and for all communications linked to them. 5. If no agreement about languages can be reached, requests for mutual assistance shall be sent in the official language, or one of the official languages, of the Member State of the applicant authority and replies in the official language, or one of the official languages, of the Member State of the requested authority. In that case, each competent authority shall be responsible for the necessary translations of the requests, replies and other documents that it receives from another competent authority. 6. The requested authority shall reply directly both to the applicant authority and to the single liaison offices of the Member States of the applicant authority and of the requested authority. Article 14 Refusal to comply with a request for mutual assistance 1. A requested authority may refuse to comply with a request for information under Article 11 if one or more of the following applies: (a) following a consultation with the applicant authority, it appears that the information requested is not needed by the applicant authority to establish whether an intra-Union infringement has occurred or is occurring, or to establish whether there is a reasonable suspicion that it may occur; (b) the applicant authority does not agree that the information is subject to the rules on confidentiality and on professional and commercial secrecy laid down in Article 33; (c) criminal investigations or judicial proceedings have already been initiated against the same trader in respect of the same intra-Union infringement before the judicial authorities in the Member State of the requested authority or of the applicant authority. 2. A requested authority may refuse to comply with a request for enforcement measures under Article 12 if, having consulted with the applicant authority, one or more of the following applies: (a) criminal investigations or judicial proceedings have already been initiated, or there is a judgment, a court settlement or a judicial order in respect of the same intra-Union infringement and against the same trader before the judicial authorities in the Member State of the requested authority; (b) the exercise of the necessary enforcement powers has already been initiated, or an administrative decision has already been adopted in respect of the same intra-Union infringement and against the same trader in the Member State of the requested authority in order to bring about the swift and effective cessation or prohibition of the intra-Union infringement; (c) following an appropriate investigation, the requested authority concludes that no intra-Union infringement has occurred; (d) the requested authority concludes that the applicant authority has not provided the information that is necessary in accordance with Article 13(1); (e) the requested authority has accepted commitments proposed by the trader to cease the intra-Union infringement within a set time limit and that time limit has not yet passed. However, the requested authority shall comply with the request for enforcement measures under Article 12 if the trader fails to implement accepted commitments within the time limit referred to in point (e) of the first subparagraph. 3. The requested authority shall inform the applicant authority and the Commission of any refusal to comply with a request for mutual assistance, together with the reasons for that refusal. 4. In the event of a disagreement between the applicant authority and the requested authority, either the applicant authority or the requested authority may refer the matter to the Commission, which shall issue an opinion on the matter without delay. Where the matter has not been referred to the Commission, the Commission may nevertheless issue an opinion on its own initiative. For the purpose of issuing that opinion, the Commission may ask for relevant information and documents that have been exchanged between the applicant authority and the requested authority. 5. The Commission shall monitor the functioning of the mutual assistance mechanism and the compliance of competent authorities with the procedures and the time limits for handling requests for mutual assistance. The Commission shall have access to the requests for mutual assistance and to the information and documents that have been exchanged between the applicant authority and requested authority. 6. Where appropriate, the Commission may issue guidance and provide advice to the Member States to ensure the effective and efficient functioning of the mutual assistance mechanism. CHAPTER IV COORDINATED INVESTIGATION AND ENFORCEMENT MECHANISMS FOR WIDESPREAD INFRINGEMENTS AND FOR WIDESPREAD INFRINGEMENTS WITH A UNION DIMENSION Article 15 Procedure for decisions amongst Member States For matters covered by this Chapter, the competent authorities concerned shall act by consensus. Article 16 General principles of cooperation 1. Where there is a reasonable suspicion that a widespread infringement or widespread infringement with a Union dimension is taking place, competent authorities concerned by that infringement and the Commission shall inform each other and the single liaison offices concerned by that infringement without delay, by issuing alerts pursuant to Article 26. 2. The competent authorities concerned by the widespread infringement or widespread infringement with a Union dimension shall coordinate the investigation and enforcement measures that they take to address those infringements. They shall exchange all necessary evidence and information and provide each other and the Commission with any necessary assistance without delay. 3. The competent authorities concerned by the widespread infringement or widespread infringement with a Union dimension shall ensure that all necessary evidence and information are gathered, and that all necessary enforcement measures are taken to bring about the cessation or prohibition of that infringement. 4. Without prejudice to paragraph 2, this Regulation shall not affect national investigation and enforcement activities carried out by competent authorities in respect of the same infringement by the same trader. 5. Where appropriate, the competent authorities may invite Commission officials and other accompanying persons, who have been authorised by the Commission, to participate in the coordinated investigations, enforcement actions and other measures covered by this Chapter. Article 17 Launch of coordinated action and designation of the coordinator 1. Where there is a reasonable suspicion of a widespread infringement, the competent authorities concerned by that infringement shall launch a coordinated action which shall be based on an agreement between them. The launch of the coordinated action shall be notified to the single liaison offices concerned by that infringement and to the Commission, without delay. 2. The competent authorities concerned by the suspected widespread infringement shall designate one competent authority concerned by the suspected widespread infringement to be the coordinator. If those competent authorities are unable to reach agreement on that designation, the Commission shall take the role of coordinator. 3. If the Commission has a reasonable suspicion of a widespread infringement with a Union dimension, it shall without delay notify the competent authorities and the single liaison offices concerned by that alleged infringement pursuant to Article 26. The Commission shall state in the notification the grounds which justify a possible coordinated action. The competent authorities concerned by the alleged widespread infringement with a Union dimension shall conduct appropriate investigations on the basis of information that is available or easily accessible to them. The competent authorities concerned by the alleged widespread infringement with a Union dimension shall notify the results of such investigations to the other competent authorities, the single liaison offices concerned by that infringement and the Commission pursuant to Article 26, within 1 month from the date of the Commission\u2019s notification. Where such investigations reveal that a widespread infringement with a Union dimension might be taking place, the competent authorities concerned by that infringement shall start with the coordinated action and shall take the measures set out in Article 19 as well as, where appropriate, the measures set out in Articles 20 and 21. 4. The coordinated actions referred to in paragraph 3 shall be coordinated by the Commission. 5. A competent authority shall join the coordinated action, if it becomes apparent during that coordinated action that the competent authority is concerned by the widespread infringement or the widespread infringement with a Union dimension. Article 18 Reasons for declining to take part in the coordinated action 1. A competent authority may decline to take part in a coordinated action for any of the following reasons: (a) in respect of the same trader, a criminal investigation or judicial proceedings have already been initiated, a judgement has been given, or a court settlement has been reached, concerning the same infringement in that competent authority\u2019s Member State; (b) the exercise of the necessary enforcement powers has already been initiated before the issuing of an alert referred to in Article 17(3), or an administrative decision has been adopted against the same trader in respect of the same infringement in that competent authority\u2019s Member State in order to bring about the swift and effective cessation or prohibition of the widespread infringement or widespread infringement with a Union dimension; (c) following an appropriate investigation, it is apparent that the actual or potential impact of the alleged widespread infringement or widespread infringement with a Union dimension in that competent authority\u2019s Member State is negligible and therefore no enforcement measures need to be adopted by that competent authority; (d) the relevant widespread infringement or the widespread infringement with a Union dimension has not occurred in that competent authority\u2019s Member State and therefore no enforcement measures need to be adopted by that competent authority; (e) the competent authority has accepted commitments proposed by the trader responsible for the widespread infringement or widespread infringement with a Union dimension to cease that infringement in that competent authority\u2019s Member State and those commitments have been implemented, and therefore no enforcement measures need to be adopted by that competent authority. 2. Where a competent authority declines to take part in the coordinated action, it shall inform the Commission and the other competent authorities and single liaison offices concerned by the widespread infringement or widespread infringement with a Union dimension about its decision without delay, stating the reasons for its decision and providing any necessary supporting documents. Article 19 Investigation measures in coordinated actions 1. The competent authorities concerned by the coordinated action shall ensure that investigations and inspections are conducted in an effective, efficient and coordinated manner. They shall seek, simultaneously with one another, to conduct investigations and inspections and, to the extent that national procedural law so allows, to apply interim measures. 2. The mutual assistance mechanism pursuant to Chapter III may be used if it is needed, in particular to gather necessary evidence and other information from Member States other than the Member States concerned by the coordinated action or to ensure that the trader concerned does not circumvent enforcement measures. 3. Where appropriate, the competent authorities concerned by the coordinated action shall set out the outcome of the investigation and the assessment of the widespread infringement or, where applicable, the widespread infringement with a Union dimension in a common position agreed upon among themselves. 4. Unless otherwise agreed between the competent authorities concerned by the coordinated action, the coordinator shall communicate the common position to the trader responsible for the widespread infringement or the widespread infringement with a Union dimension. The trader responsible for the widespread infringement or the widespread infringement with a Union dimension shall be given the opportunity to be heard on the matters forming part of the common position. 5. Where appropriate, and without prejudice to Article 15 or to the rules on confidentiality and on professional and commercial secrecy laid down in Article 33, the competent authorities concerned by the coordinated action shall decide to publish the common position or parts thereof on their websites, and may seek the views of consumer organisations, trader associations and other parties concerned. The Commission shall publish the common position or parts thereof on its website with the agreement of the competent authorities concerned. Article 20 Commitments in coordinated actions 1. On the basis of a common position adopted pursuant to Article 19(3), the competent authorities concerned by the coordinated action may invite the trader responsible for the widespread infringement or the widespread infringement with a Union dimension to propose within a set time limit commitments to cease that infringement. The trader may also, on his own initiative, propose commitments to cease that infringement or offer remedial commitments to consumers that have been affected by that infringement. 2. Where appropriate and without prejudice to the rules on confidentiality and on professional and commercial secrecy laid down in Article 33, the competent authorities concerned by the coordinated action, may publish the commitments proposed by the trader responsible for the widespread infringement or the widespread infringement with a Union dimension on their websites or, if appropriate, the Commission may publish the commitments proposed by that trader on its website if so requested by the competent authorities concerned. Competent authorities and the Commission may seek the views of consumer organisations, trader associations and other parties concerned. 3. The competent authorities concerned by the coordinated action shall assess the proposed commitments and communicate the outcome of the assessment to the trader responsible for the widespread infringement or the widespread infringement with a Union dimension, and, where applicable, if remedial commitments have been offered by the trader, they shall inform consumers that claim that they have suffered harm as a consequence of that infringement. Where commitments are proportionate and are sufficient to bring about the cessation of the widespread infringement or the widespread infringement with a Union dimension, the competent authorities shall accept those commitments and set a time limit within which the commitments have to be implemented. 4. The competent authorities concerned by the coordinated action shall monitor the implementation of the commitments. They shall in particular ensure that the trader responsible for the widespread infringement or the widespread infringement with a Union dimension regularly reports to the coordinator about the progress of the implementation of the commitments. The competent authorities concerned by the coordinated action may, where appropriate, seek the views of consumer organisations and experts to verify whether the steps taken by the trader comply with the commitments. Article 21 Enforcement measures in coordinated actions 1. The competent authorities concerned by the coordinated action shall take within their jurisdiction all necessary enforcement measures against the trader responsible for the widespread infringement or the widespread infringement with a Union dimension to bring about the cessation or prohibition of that infringement. Where appropriate, they shall impose penalties, such as fines or periodic penalty payments, on the trader responsible for the widespread infringement or the widespread infringement with a Union dimension. The competent authorities may receive from the trader, on the trader\u2019s initiative, additional remedial commitments for the benefit of consumers that have been affected by the alleged widespread infringement or the alleged widespread infringement with a Union dimension, or, where appropriate, may seek to obtain commitments from the trader to offer adequate remedies to the consumers that have been affected by that infringement. Enforcement measures are in particular appropriate where: (a) an immediate enforcement action is necessary to bring about the swift and effective cessation or prohibition of the infringement; (b) it is unlikely that the infringement will cease as a result of the commitments proposed by the trader responsible for the infringement; (c) the trader responsible for the infringement has not proposed commitments before the expiry of a time limit set by the competent authorities concerned; (d) the commitments that the trader responsible for the infringement proposed are insufficient to ensure the cessation of the infringement or, where appropriate, to provide a remedy to consumers harmed by the infringement; or (e) the trader responsible for the infringement has failed to implement the commitments to cease the infringement or, where appropriate, to provide a remedy to consumers harmed by the infringement, within the time limit referred to in Article 20(3). 2. Enforcement measures pursuant to paragraph 1 shall be taken in an effective, efficient and coordinated manner to bring about the cessation or prohibition of the widespread infringement or the widespread infringement with a Union dimension. The competent authorities concerned by the coordinated action shall seek to take enforcement measures simultaneously in the Member States concerned by that infringement. Article 22 Closure of the coordinated actions 1. The coordinated action shall be closed if the competent authorities concerned by the coordinated action conclude that the widespread infringement or widespread infringement with a Union dimension has ceased or has been prohibited in all Member States concerned, or that no such infringement was committed. 2. The coordinator shall notify the Commission and, where applicable, the competent authorities and the single liaison offices of the Member States concerned by the coordinated action of the closure of the coordinated action without delay. Article 23 Role of the coordinator 1. The coordinator appointed in accordance with Article 17 or 29 shall in particular: (a) ensure that all the competent authorities concerned and the Commission are duly informed, in a timely manner, of the progress of the investigation or of the enforcement action, as applicable, and informed of any anticipated next steps and the measures to be adopted; (b) coordinate and monitor the investigation measures taken by the competent authorities concerned in accordance with this Regulation; (c) coordinate the preparation and sharing of all necessary documents among the competent authorities concerned and the Commission; (d) maintain contact with the trader and other parties concerned by the investigation or enforcement measures, as applicable, unless otherwise agreed by the competent authorities concerned and the coordinator; (e) where applicable, coordinate the assessment, the consultations and the monitoring by the competent authorities concerned as well as other steps necessary to process and implement commitments proposed by the traders concerned; (f) where applicable, coordinate enforcement measures adopted by the competent authorities concerned; (g) coordinate requests for mutual assistance submitted by the competent authorities concerned pursuant to Chapter III. 2. The coordinator shall not be held responsible for the actions or the omissions of the competent authorities concerned when they make use of the powers set out in Article 9. 3. Where the coordinated actions concern widespread infringements or widespread infringements with a Union dimension of the legal acts of the Union referred to in Article 2(10), the coordinator shall invite the European Banking Authority to act as an observer. Article 24 Language arrangements 1. The languages used by the competent authorities for notifications, as well as for all other communications covered by this Chapter which are linked to the coordinated actions and sweeps shall be agreed upon by the competent authorities concerned. 2. If no agreement can be reached between the competent authorities concerned, notifications and other communications shall be sent in the official language or one of the official languages of the Member State making the notification or other communication. In that case, if necessary, each competent authority concerned shall be responsible for translating the notifications, communications and other documents that it receives from other competent authorities. Article 25 Language arrangements for communication with traders For the purposes of the procedures set out in this Chapter, the trader shall be entitled to communicate in the official language or one of the official languages used for official purposes of the Member State in which the trader is established or resides. CHAPTER V UNION-WIDE ACTIVITIES Article 26 Alerts 1. A competent authority shall without delay notify the Commission, other competent authorities and single liaison offices of any reasonable suspicion that an infringement covered by this Regulation that may affect consumers\u2019 interests in other Member States is taking place on its territory. 2. The Commission shall without delay notify the competent authorities and single liaison offices concerned of any reasonable suspicion that an infringement covered by this Regulation has occurred. 3. When notifying, that is to say issuing an alert, under paragraphs 1 and 2 the competent authority or the Commission shall provide information about the suspected infringement covered by this Regulation, and in particular, and, where available, the following: (a) a description of the act or omission that constitutes the infringement; (b) details of the product or service concerned by the infringement; (c) the names of the Member States concerned or possibly concerned by the infringement; (d) the identity of the trader or traders responsible or suspected of being responsible for the infringement; (e) the legal basis for possible actions by reference to national law and the corresponding provisions of the Union legal acts listed in the Annex; (f) a description of any legal proceedings, enforcement measures or other measures taken concerning the infringement and their dates and duration, as well as the status thereof; (g) the identities of the competent authorities bringing the legal proceedings and taking other measures. 4. When issuing an alert, the competent authority may ask competent authorities and the relevant single liaison offices in other Member States and the Commission, or the Commission may ask competent authorities and the relevant single liaison offices in other Member States, to verify whether, based on information that is available or easily accessible to the relevant competent authorities or to the Commission, respectively, similar suspected infringements are taking place in the territory of those other Member States or whether any enforcement measures have already been taken against such infringements in those Member States. Those competent authorities of other Member States and the Commission shall reply to the request without delay. Article 27 External alerts 1. Each Member State shall, unless to do so would not be justified, confer on designated bodies, European Consumer Centres, consumer organisations and associations, and, where appropriate, trader associations, that have the necessary expertise, the power to issue an alert to the competent authorities of the relevant Member States and the Commission of suspected infringements covered by this Regulation and to provide information available to them set out in Article 26(3) (\u2018external alert\u2019). Each Member State shall without delay notify the Commission of the list of those entities and of any changes to it. 2. The Commission, after consulting the Member States, shall confer on associations representing consumer, and, where appropriate, trader, interests at a Union level the power to issue an external alert. 3. The competent authorities shall not be bound to initiate a procedure or take any other action in response to an external alert. Entities issuing external alerts shall ensure that the information provided is correct, up to date and accurate, and shall correct the notified information without delay, or withdraw it as appropriate. Article 28 Exchange of other information relevant for the detection of infringements To the extent necessary to achieve the objective of this Regulation, competent authorities shall, via the electronic database referred to in Article 35, notify the Commission and competent authorities of Member States concerned without delay of any measure that they have taken to address an infringement covered by this Regulation within their jurisdiction if they suspect that the infringement in question may affect consumers\u2019 interests in other Member States. Article 29 Sweeps 1. The competent authorities may decide to conduct sweeps to check compliance with, or to detect infringements of Union laws that protect consumers\u2019 interests. Unless otherwise agreed upon by the competent authorities involved, sweeps shall be coordinated by the Commission. 2. When conducting sweeps, the competent authorities involved may use the investigation powers set out in Article 9(3) and any other powers conferred upon them by national law. 3. The competent authorities may invite designated bodies, Commission officials, and other accompanying persons authorised by the Commission, to participate in sweeps. Article 30 Coordination of other activities contributing to investigation and enforcement 1. To the extent necessary to achieve the objective of this Regulation, Member States shall inform each other and the Commission of their activities in the following areas: (a) the training of their officials involved in the application of this Regulation; (b) the collection, classification and exchange of data on consumer complaints; (c) the development of sector-specific networks of officials; (d) the development of information and communication tools; and (e) where applicable, the development of standards, methodologies and guidelines concerning the application of this Regulation. 2. To the extent necessary to achieve the objective of this Regulation, Member States may coordinate and jointly organise activities in the areas referred to in paragraph 1. Article 31 Exchange of officials between competent authorities 1. The competent authorities may participate in exchange schemes for officials from other Member States in order to improve cooperation. The competent authorities shall take the necessary measures to enable officials from other Member States to play an effective role in the activities of the competent authority. To that end, those officials shall be authorised to carry out the duties entrusted to them by the host competent authority in accordance with the laws of its Member State. 2. During the exchange, the civil and criminal liability of the official shall be treated in the same way as that of the officials of the host competent authority. The officials from other Member States shall comply with professional standards and the appropriate internal rules of conduct of the host competent authority. Those rules of conduct shall ensure in particular the protection of individuals with regard to the processing of personal data, procedural fairness and the proper observance of the rules on confidentiality and on professional and commercial secrecy laid down in Article 33. Article 32 International cooperation 1. To the extent necessary to achieve the objective of this Regulation, the Union shall cooperate with third countries and with the competent international organisations in the areas covered by this Regulation in order to protect consumers\u2019 interests. The Union and the third countries concerned may conclude agreements setting out arrangements for cooperation, including the establishment of mutual assistance arrangements, the exchange of confidential information and exchange of staff programmes. 2. Agreements concluded between the Union and third countries concerning cooperation and mutual assistance to protect and enhance consumers\u2019 interests shall respect the relevant data protection rules applicable to the transfer of personal data to third countries. 3. When a competent authority receives information that is potentially of relevance for the competent authorities of other Member States from an authority of a third country, it shall communicate the information to those competent authorities insofar as it is permitted to do so under any applicable bilateral assistance agreements with that third country and insofar as that information is in accordance with Union law regarding the protection of individuals with regard to the processing of personal data. 4. Information communicated under this Regulation may also be communicated to an authority of a third country by a competent authority under a bilateral assistance agreement with that third country, provided that the approval of the competent authority that originally communicated the information has been obtained, and provided that it is in accordance with Union law regarding the protection of individuals with regard to the processing of personal data. CHAPTER VI COMMON ARRANGEMENTS Article 33 Use and disclosure of information and professional and commercial secrecy 1. Information collected by or communicated to the competent authorities and the Commission in the course of applying this Regulation shall only be used for the purposes of ensuring compliance with Union laws that protect consumers\u2019 interests. 2. The information referred to in paragraph 1 shall be treated as confidential and shall only be used and disclosed with due regard to the commercial interests of a natural person or legal person, including trade secrets and intellectual property. 3. Nevertheless, the competent authorities may, after consulting the competent authority which provided the information, disclose such information that is necessary: (a) to prove infringements covered by this Regulation; or (b) to bring about the cessation or prohibition of infringements covered by this Regulation. Article 34 Use of evidence and investigation findings Competent authorities may use as evidence any information, documents, findings, statements, certified true copies or intelligence communicated, on the same basis as similar documents obtained in their own Member State, irrespective of their storage medium. Article 35 Electronic database 1. The Commission shall establish and maintain an electronic database for all communications between competent authorities, single liaison offices and the Commission under this Regulation. All information sent by the means of the electronic database shall be stored and processed in that electronic database. That database shall be directly accessible to the competent authorities, single liaison offices and the Commission. 2. Information provided by entities issuing an external alert pursuant to Article 27(1) or (2) shall be stored and processed in the electronic database. However, those entities shall not have access to that database. 3. Where a competent authority, a designated body or an entity issuing an external alert pursuant to Article 27(1) or (2) establishes that an alert concerning an infringement that it issued pursuant to Article 26 or 27 has subsequently been shown to be unfounded, it shall withdraw that alert. The Commission shall remove the relevant information from the database without delay, and shall inform the parties of the reasons for that removal. The data relating to an infringement shall be stored in the electronic database for no longer than is necessary for the purposes for which they were collected and processed, but shall not be stored for longer than 5 years following the day on which: (a) a requested authority notifies the Commission pursuant to Article 12(2) that an intra- Union infringement has ceased; (b) the coordinator notifies the closure of the coordinated action pursuant to Article 22(1); or (c) the information has been entered in the database in all other cases. 4. The Commission shall adopt implementing acts laying down the practical and operational arrangements for the functioning of the electronic database. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 38(2). Article 36 Waiver of reimbursement of expenses 1. Member States shall waive all claims for the reimbursement of expenses incurred in applying this Regulation. 2. Notwithstanding paragraph 1, as regards requests for enforcement measures under Article 12, the Member State of the applicant authority shall remain liable to the Member State of the requested authority for any costs and any losses incurred as a result of measures that have been dismissed and held to be unfounded by a court, as far as the substance of the infringement in question is concerned. Article 37 Enforcement priorities 1. By 17 January 2020 and every 2 years thereafter, Member States shall exchange information on their enforcement priorities for the application of this Regulation with one another and with the Commission. Such information shall include: (a) information concerning market trends that might affect consumers\u2019 interests in the Member State concerned and in other Member States; (b) an overview of actions carried out under this Regulation in the last 2 years, and in particular, investigation and enforcement measures related to the widespread infringements; (c) statistics exchanged by means of alerts referred to in Article 26; (d) the tentative priority areas, for the next 2 years, for the enforcement of the Union laws that protect consumers\u2019 interests in the Member State concerned; and (e) the proposed priority areas, for the next 2 years, for the enforcement of the Union laws that protect consumers\u2019 interests at the Union level. 2. Without prejudice to Article 33, every 2 years, the Commission shall produce an overview of the information referred to in points (a), (b) and (c) of paragraph 1 and shall make it publicly available. The Commission shall inform the European Parliament thereof. 3. In cases involving a substantial change of circumstances or of market conditions during the 2 years after the last submission of information on their enforcement priorities, Member States shall update their enforcement priorities and shall inform other Member States and the Commission accordingly. 4. The Commission shall summarise the enforcement priorities submitted by the Member States under paragraph 1 of this Article and shall report annually to the committee referred to in Article 38(1) in order to facilitate the prioritisation of actions under this Regulation. The Commission shall exchange best practices and benchmarking with the Member States, in particular with a view of developing capacity building activities. CHAPTER VII FINAL PROVISIONS Article 38 Committee 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 39 Notifications Member States shall without delay communicate to the Commission the text of any provisions of national law on matters covered by this Regulation that they adopt, as well as the text of agreements, on matters covered by this Regulation, other than agreements dealing with individual cases that they conclude. Article 40 Reporting 1. By 17 January 2023, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. 2. That report shall contain an evaluation of the application of this Regulation, including an assessment of the effectiveness of enforcement of Union laws that protect consumers\u2019 interests under this Regulation, in particular with regard to the powers of competent authorities set out in Article 9, along with, in particular, an examination of how compliance by traders with Union laws that protect consumers\u2019 interests has evolved in key consumer markets concerned by cross-border trade. That report shall be accompanied, where necessary, by a legislative proposal. Article 41 Repeal Regulation (EC) No 2006/2004 is repealed with effect from 17 January 2020. Article 42 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 17 January 2020. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 12 December 2017. For the European Parliament The President A. TAJANI For the Council The President M. MAASIKAS (1) OJ C 34, 2.2.2017, p. 100. (2) Position of the European Parliament of 14 November 2017 (not yet published in the Official Journal) and decision of the Council of 30 November 2017. (3) Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (the Regulation on consumer protection cooperation) (OJ L 364, 9.12.2004, p. 1). (4) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (\u2018Directive on electronic commerce\u2019) (OJ L 178, 17.7.2000, p. 1). (5) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (6) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (7) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (8) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (9) Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34). (10) Directive 2014/92/EU of the European Parliament and of the Council of 23 July 2014 on the comparability of fees related to payment accounts, payment account switching and access to payment accounts with basic features (OJ L 257, 28.8.2014, p. 214). (11) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). (12) Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers\u2019 interests (OJ L 110, 1.5.2009, p. 30). ANNEX Directives and Regulations referred to in point (1) of Article 3 1. Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29). 2. Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ L 80, 18.3.1998, p. 27). 3. Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, p. 12). 4. Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). 5. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67): Articles 86 to 100. 6. Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37): Article 13. 7. Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC (OJ L 271, 9.10.2002, p. 16). 8. Regulation (EC) No 261/2004 of the European Parliament and of the Council of 11 February 2004 establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, and repealing Regulation (EEC) No 295/91 (OJ L 46, 17.2.2004, p. 1). 9. Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (\u2018Unfair Commercial Practices Directive\u2019) (OJ L 149, 11.6.2005, p. 22). 10. Regulation (EC) No 1107/2006 of the European Parliament and of the Council of 5 July 2006 concerning the rights of disabled persons and persons with reduced mobility when travelling by air (OJ L 204, 26.7.2006, p. 1). 11. Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (OJ L 376, 27.12.2006, p. 21): Article 1, point (c) of Article 2 and Articles 4 to 8. 12. Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36): Article 20. 13. Regulation (EC) No 1371/2007 of the European Parliament and of the Council of 23 October 2007 on rail passengers\u2019 rights and obligations (OJ L 315, 3.12.2007, p. 14). 14. Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66). 15. Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community (OJ L 293, 31.10.2008, p. 3): Articles 22, 23 and 24. 16. Directive 2008/122/EC of the European Parliament and of the Council of 14 January 2009 on the protection of consumers in respect of certain aspects of timeshare, long-term holiday product, resale and exchange contracts (OJ L 33, 3.2.2009, p. 10). 17. Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, p. 1): Articles 9, 10, 11 and Articles 19 to 26. 18. Regulation (EU) No 1177/2010 of the European Parliament and of the Council of 24 November 2010 concerning the rights of passengers when travelling by sea and inland waterway and amending Regulation (EC) No 2006/2004 (OJ L 334, 17.12.2010, p. 1). 19. Regulation (EU) No 181/2011 of the European Parliament and of the Council of 16 February 2011 concerning the rights of passengers in bus and coach transport and amending Regulation (EC) No 2006/2004 (OJ L 55, 28.2.2011, p. 1). 20. Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). 21. Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Directive on consumer ADR) (OJ L 165, 18.6.2013, p. 63): Article 13. 22. Regulation (EU) No 524/2013 of the European Parliament and of the Council of 21 May 2013 on online dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Regulation on consumer ODR) (OJ L 165, 18.6.2013, p. 1): Article 14. 23. Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34): Articles 10, 11, 13, 14, 15, 16, 17, 18, 21, 22, 23, Chapter 10 and Annexes I and II. 24. Directive 2014/92/EU of the European Parliament and of the Council of 23 July 2014 on the comparability of fees related to payment accounts, payment account switching and access to payment accounts with basic features (OJ L 257, 28.8.2014, p. 214): Articles 3 to 18 and Article 20(2). 25. Directive (EU) 2015/2302 of the European Parliament and of the Council of 25 November 2015 on package travel and linked travel arrangements, amending Regulation (EC) No 2006/2004 and Directive 2011/83/EU of the European Parliament and of the Council and repealing Council Directive 90/314/EEC (OJ L 326, 11.12.2015, p. 1). 26. Regulation (EU) 2017/1128 of the European Parliament and of the Council of 14 June 2017 on cross-border portability of online content services in the internal market (OJ L 168, 30.6.2017, p. 1).", "summary": "Cooperation between national authorities on consumer protection laws Cooperation between national authorities on consumer protection laws SUMMARY OF: Regulation (EU) 2017/2394 \u2014 cooperation between national authorities for the enforcement of consumer protection laws WHAT IS THE AIM OF THE REGULATION? It aims to protect consumers against cross-border infringements to EU consumer law by modernising the cooperation of the relevant national authorities in EU, European Economic Area (EEA) and European Free Trade Association (EFTA) countries among themselves and with the European Commission. The new rules help increase consumers\u2019 and businesses\u2019 trust in e-commerce within the EU. It repeals and replaces Regulation (EC) No 2006/2004 as of 17 January 2020. KEY POINTS Scope The regulation covers 26 EU laws that protect consumers\u2019 interests listed in its annex (new ones may be added in the future to extend the scope of the Regulation to new legislative areas) and it applies in case of any infringement of those laws. These infringements can be: intra-EU infringements: where consumers live in an EU country other than that in which the infringement took placethe trader responsible is based orwhere the relevant evidence or assets are to be found; widespread infringements: an act or an omission contrary to EU consumer protection law that harms or is likely to harm the collective interests of consumers in at least 2 EU countries other than the country in which it originated or took placethe trader responsible for it is basedwhere the evidence or assets of the trader involved are to be found; or any acts or omissions contrary to EU consumer protection laws that harm or are likely to harm the collective interests of consumers and that have common features, including the same unlawful practicethe same interest being infringed andthat are occurring concurrentlycommitted by the same trader, in at least 3 EU countries; widespread infringements with an EU dimension: the consumers affected reside in at least two thirds of the EU countries, representing at least two thirds of the EU population. The infringement can be an act or an omission, and may have ceased before enforcement starts or is completed. Competent authorities Each EU country must designate and provide resources for: a single liaison office responsible for coordinating investigation and enforcement activities and for ensuring effective cooperation; one or more competent authorities responsible for the application of the regulation. EU countries may also involve designated bodies, where necessary, to gather information regarding an infringement or to take enforcement measures, under certain conditions of the regulation. The regulation lists the minimum investigative and enforcement powers of the competent authorities, including the power to obtain commitments from a trader to cease an infringement or to provide remedies to the affected consumers . Moreover, authorities will also be able to: request information from domain registrars and banks to detect the identity of the responsible trader; carry out test purchases (\u2018mystery shopping\u2019) to check geographical discrimination or after-sales conditions (e.g. withdrawal rights); and order the removal of online content if necessary. Mutual assistance For intra-EU infringements, the regulation lays out the procedure for requests for information and for enforcement measures from one EU country to another. Authorities must respond to requests for information within 30 days unless otherwise agreed, and must apply appropriate enforcement measures without delay and normally within 6 months. The regulation also covers the conditions under which such a request may be turned down. Coordinated action Where there is a reasonable suspicion of a widespread infringement, the authorities concerned must alert without delay the Commission, other competent authorities and liaison offices, and launch coordinated action where agreed, with a designated coordinator. The Commission must report any suspected infringements of which it has become aware to the national authorities. If there is a suspicion of a wide-scale EU-wide infringement, national authorities must conduct appropriate investigations and start a coordinated action if such investigations confirm that an infringement might be taking place. Coordinated actions to address widespread infringements with an EU dimension must always be coordinated by the Commission. EU countries may refuse to participate in a coordinated action, for example if there are already judicial proceedings or if an investigation has shown that the actual or potential effects of the alleged infringement are negligible in that country. EU-wide activities The regulation also introduces a new EU-wide market alert system, so that emerging threats are detected more rapidly. This new alert system combines the system already existing under the consumer protection cooperation regulation (Regulation (EC) No 2006/2004) with a wider exchange of relevant and necessary information. In addition, certain external bodies (such as consumer and trade associations, the European Consumer Centres and designated bodies given this power by the EU countries or by the Commission) will also be able to send alerts (\u2018external alerts\u2019). This increases the role of stakeholders in the enforcement of consumer protection law. The authorities may also decide to conduct sweeps* to detect infringements, but these must normally be coordinated by the Commission. Data protection Authorities may directly request relevant data from third parties in accordance with Directive 2000/31/EC (on e-commerce) and respecting data protection legislation (Regulation (EC) No 45/2001 on European Data Protection Supervisor, Regulation (EU) 2016/679 \u2014 general data protection regulation (GDPR) and Directive (EU) 2016/680 \u2014 Protecting personal data when being used by police and criminal justice authorities). FROM WHEN DOES THE REGULATION APPLY? It applies from 17 January 2020. BACKGROUND For more information, see: Coordinated enforcement of consumer rights (European Commission). KEY TERMS Sweeps: coordinated investigations of a consumer market. MAIN DOCUMENT Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, pp. 1-26) RELATED DOCUMENTS Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, pp. 89-131) Successive amendments to Regulation (EU) 2016/680 have been incorporated in the original text. This consolidated version is of documentary value only. Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (the Regulation on consumer protection cooperation) (OJ L 364, 9.12.2004, pp. 1-11) See consolidated version. Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, pp. 1-22) See consolidated version. Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (\u2018Directive on electronic commerce\u2019) (OJ L 178, 17.7.2000, pp. 1-16) last update 14.05.2018"}
{"article": "5.5.2017 EN Official Journal of the European Union L 117/176 REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Directive 98/79/EC of the European Parliament and of the Council (3) constitutes the Union regulatory framework for in vitro diagnostic medical devices. However, a fundamental revision of that Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation. (2) This Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods. As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices by ensuring, among other things, that data generated in performance studies are reliable and robust and that the safety of subjects participating in performance studies is protected. (3) This Regulation does not seek to harmonise rules relating to the further making available on the market of in vitro diagnostic medical devices after they have already been put into service, such as in the context of second-hand sales. (4) Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices should be introduced, to improve health and safety. (5) To the extent possible, guidance developed for in vitro diagnostic medical devices at international level, in particular in the context of the Global Harmonization Task Force and its follow-up initiative, the International Medical Devices Regulators Forum, should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical evidence. (6) There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned. (7) The scope of application of this Regulation should be clearly delimited from other legislation concerning products, such as medical devices, general laboratory products and products for research use only. (8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (\u2018MDCG\u2019), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority, as relevant. (9) It appears that it is possible that divergent national rules regarding the provision of information and counselling in relation to genetic testing might only have an impact on the smooth functioning of the internal market to a limited extent. Therefore, it is appropriate to lay down only limited requirements in this regard in this Regulation, having regard to the need to ensure constant respect of the principles of proportionality and subsidiarity. (10) It should be made clear that all tests that provide information on the predisposition to a medical condition or a disease, such as genetic tests, and tests that provide information to predict treatment response or reactions, such as companion diagnostics, are in vitro diagnostic medical devices. (11) Companion diagnostics are essential for defining patients' eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at a higher risk of developing an adverse reaction to the medicinal product in question or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective. Such biomarker or biomarkers can be present in healthy subjects and/or in patients. (12) Devices that are used with a view to monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be companion diagnostics. (13) The requirement to reduce risks as far as possible should be fulfilled taking into account the generally acknowledged state of the art in the field of medicine. (14) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (4) are an integral part of the general safety and performance requirements laid down in this Regulation for devices. Consequently, this Regulation should be considered a lex specialis in relation to that Directive. (15) This Regulation should include requirements regarding the design and manufacture of devices emitting ionizing radiation without affecting the application of Council Directive 2013/59/Euratom (5) which pursues other objectives. (16) This Regulation should include requirements for devices' safety and performance characteristics which are developed in such a way as to prevent occupational injuries, including protection from radiation. (17) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic medical device, qualifies as an in vitro diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being purposes is not an in vitro diagnostic medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device. (18) The definitions in this Regulation regarding the devices themselves, the making available of devices, economic operators, users and specific processes, the conformity assessment, clinical evidence, post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should be aligned with well-established practice in the field at Union and international level in order to enhance legal certainty. (19) It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council (6) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union. (20) To recognise the important role of standardisation in the field of in vitro diagnostic medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (7) should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation. (21) Directive 98/79/EC allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance requirements and the requirements for performance studies and performance evaluation and/or post-market follow-up, laid down in this Regulation. (22) Common specifications (\u2018CS\u2019) should be developed after consulting the relevant stakeholders and taking account of the European and international standards. (23) The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the Council (8) and Decision No 768/2008/EC of the European Parliament and of the Council (9). (24) The rules on Union market surveillance and control of products entering the Union market laid down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks. (25) It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors, building on the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the various parts of this Regulation, to enhance understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators. (26) For the purpose of this Regulation, the activities of distributors should be deemed to include acquisition, holding and supplying of devices. (27) Several of the obligations on manufacturers, such as performance evaluation or vigilance reporting, that were set out only in the Annexes to Directive 98/79/EC, should be incorporated into the enacting provisions of this Regulation to facilitate its application. (28) To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices, manufactured and used within a single health institution only, should be clarified and strengthened. That use should be understood to include measurement and delivery of results. (29) Health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby addressing, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market. In that context, it is appropriate to provide that certain rules of this Regulation, as regards devices manufactured and used only within health institutions, including hospitals as well as institutions, such as laboratories and public health institutes that support the health care system and/or address patient needs, but which do not treat or care for patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner. It should be noted that the concept of \u2018health institution\u2019 does not cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption applicable to health institutions does not apply to such establishments. (30) In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC (10). Such measures should be proportionate to the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device. (31) To ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question. In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting incidents and field safety corrective actions. (32) The risk management system should be carefully aligned with and reflected in the performance evaluation process for the device, including the clinical risks to be addressed as part of performance studies, performance evaluation and post-market performance follow-up. The risk management and performance evaluation processes should be inter-dependent and should be regularly updated. (33) It should be ensured that supervision and control of the manufacture of devices, as well as post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification. (34) For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance. (35) To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify when a distributor, importer or other person is to be considered the manufacturer of a device. (36) Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety and from the need for protection of intellectual property rights provided for under Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different interpretations in the Member States. The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the Court of Justice (11) in other relevant sectors and existing good practice in the field of in vitro diagnostic medical devices. (37) Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to the placing on the market or putting into service of devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation. (38) The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those settings. (39) The UDI system should apply to all devices placed on the market except devices for performance studies, and be based on internationally recognised principles including definitions that are compatible with those used by major trade partners. In order for the UDI system to become functional in time for the application of this Regulation, detailed rules should be laid down in this Regulation and in Regulation (EU) 2017/745 of the European Parliament and of the Council (12). (40) Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system. (41) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, performance studies, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission. Within the internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices set up by Commission Decision 2010/227/EU (13). (42) To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably practicable, free of charge also to other stakeholders. (43) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on performance studies should serve as a tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and to report serious adverse events, device deficiencies and related updates. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of the evaluation of such incidents and events by competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. (44) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the European Parliament and of the Council (14) applies to the processing of personal data carried out in the Member States, under the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (15) applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. In accordance with Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems. (45) For class C and D devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the performance evaluation in a document that should be publicly available. (46) The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level. (47) Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on performance evaluation, should be critically evaluated by the authority responsible for notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities of notified bodies and should be based on sampling of the relevant documentation. (48) The position of notified bodies vis-\u00e0-vis manufacturers should be strengthened, including with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification. (49) To increase transparency with regard to the oversight of notified bodies by national authorities, the authorities responsible for notified bodies should publish information on the national measures governing the assessment, designation and monitoring of notified bodies. In accordance with good administrative practice, this information should be kept up to date by those authorities in particular to reflect relevant, significant or substantive changes to the procedures in question. (50) The Member State in which a notified body is established should be responsible for enforcing the requirements of this Regulation with regard to that notified body. (51) In view, in particular, of the responsibility of Member States for the organisation and delivery of health services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for the conformity assessment of devices and established on their territory as far as issues that are not regulated in this Regulation are concerned. Any such additional requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal treatment of notified bodies. (52) For class D devices, competent authorities should be informed about certificates granted by notified bodies and be given the right to scrutinise the assessment conducted by notified bodies. (53) For class D devices for which no CS exist it is appropriate to provide that where it is the first certification for that specific type of device and there is no similar device on the market having the same intended purpose and based on similar technology, notified bodies should, in addition to the laboratory testing of the performance claimed by the manufacturer and the compliance of the device by the EU reference laboratories, be obliged to request expert panels to scrutinise their performance evaluation assessment reports. The consultation of expert panels in relation to the performance evaluation should lead to a harmonised evaluation of high-risk in vitro diagnostic medical devices by sharing expertise on performance aspects and developing CS on categories of devices that have undergone that consultation process. (54) To enhance patient safety and to take due account of technological progress, the current classification system for devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the corresponding conformity assessment procedures should be accordingly adapted. (55) It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in four risk classes and to establish a set of robust risk-based classification rules, in line with international practice. (56) The conformity assessment procedure for class A devices should be carried out, as a general rule, under the sole responsibility of manufacturers, since such devices pose a low risk to patients. For class B, class C and class D devices, an appropriate level of involvement of a notified body should be compulsory. (57) The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field. (58) It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity. (59) It is necessary to clarify the requirements regarding batch release verification for the highest risk devices. (60) EU reference laboratories should be enabled to verify by laboratory testing the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. (61) To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical evidence. It is necessary to clarify the requirements for the demonstration of the clinical evidence, that is based on data on scientific validity, and the analytical performance and clinical performance of the device. To allow for a structured and transparent process, generating reliable and robust data, sourcing and assessment of available scientific information and data generated in performance studies should be based on a performance evaluation plan. (62) As a general rule, clinical evidence should be sourced from performance studies that have been carried out under the responsibility of a sponsor. It should be possible both for the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the performance study. (63) It is necessary to ensure that the clinical evidence of devices is updated throughout their lifecycle. Such updating entails the planned monitoring of scientific developments and changes in medical practice by the manufacturer. Relevant new information should then trigger a reassessment of the clinical evidence of the device thus ensuring safety and performance through a continuous process of performance evaluation. (64) It should be recognised that the concept of clinical benefit for in vitro diagnostic medical devices is fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical devices, since the benefit of in vitro diagnostic medical devices lies in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available. (65) Where specific devices have no analytical or clinical performance or specific performance requirements are not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions relating to such requirements. (66) The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies conducted outside the Union in accordance with international guidelines to be accepted within the Union. In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects. (67) It should be left to the Member State where a performance study is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a performance study and to organise the involvement of ethics committees within the timelines for the authorisation of that performance study as set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that context, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the necessary expertise is available. (68) An electronic system should be set up at Union level to ensure that every interventional clinical performance study and other performance study involving risks for the subjects of the studies is recorded and reported in a publicly accessible database. To protect the right to protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union (\u2018the Charter\u2019), no personal data of subjects participating in a performance study should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use. (69) Where an interventional clinical performance study or another performance study involving risks for the subjects is to be conducted in more than one Member State, the sponsor should have the possibility of submitting a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the device for performance study and of the scientific design of that performance study, the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a performance study, including informed consent. For an initial period of seven years from the date of application of this Regulation, Member States should be able to participate on a voluntary basis in the coordinated assessment. After that period, all Member States should be obliged to participate in the coordinated assessment. The Commission, based on the experience gained from the voluntary coordination between Member States, should draw up a report on the application of the relevant provisions regarding the coordinated assessment procedure. In the event that the findings of the report are negative, the Commission should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment procedure. (70) Sponsors should report certain adverse events and device deficiencies that occur during interventional clinical performance studies and other performance studies involving risks for the subjects to the Member States in which those studies are being conducted. Member States should have the possibility of terminating or suspending the studies or revoking the authorisation for those studies, if considered necessary to ensure a high level of protection of the subjects participating in such studies. Such information should be communicated to the other Member States. (71) The sponsor of a performance study should submit a summary of results of the performance study that is easily understandable for the intended user together with the performance study report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results will be submitted. (72) With exemption of some general requirements, this Regulation should only cover performance studies intended to gather scientific data for the purpose of demonstrating conformity of devices. (73) It is necessary to clarify that performance studies using left-over specimens need not be authorised. Nevertheless, the general requirements and other additional requirements with regard to data protection and the requirements applicable to procedures that are performed in accordance with national law such as ethical review should continue to apply to all performance studies, including when using left-over specimens. (74) The principles of replacement, reduction and refinement in the area of animal experimentation laid down in the Directive 2010/63/EU of the European Parliament and the Council (16) should be observed. In particular, the unnecessary duplication of tests and studies should be avoided. (75) Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities. To that end, manufacturers should establish a comprehensive post-market surveillance system, set up under their quality management system and based on a post-market surveillance plan. Relevant data and information gathered through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and performance evaluation, and should also serve the purposes of transparency. (76) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance for devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions. (77) Member States should take appropriate measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be encouraged and enabled to report suspected serious incidents at national level using harmonised formats. The national competent authorities should inform manufacturers of any suspected serious incident and, where a manufacturer confirms that such an incident might have occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents. (78) The evaluation of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective action. (79) In the context of the investigation of incidents, the competent authorities should take into account, where appropriate, the information provided by and views of relevant stakeholders, including patient and healthcare professionals' organisations and manufacturers' associations. (80) The reporting of serious adverse events or device deficiencies during interventional clinical performance studies and other performance studies involving risks for the subjects, and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting. (81) Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures. (82) Any statistically significant increase in the number or severity of incidents that are not serious or in expected erroneous results that could have a significant impact on the benefit-risk analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to permit their assessment and the adoption of appropriate measures. (83) An expert committee, the MDCG, composed of persons designated by the Member States based on their role and expertise in the field of medical devices including in vitro diagnostic medical devices, should be established in accordance with the conditions and modalities defined in Regulation (EU) 2017/745 to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/745, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation. The MDCG should be able to establish subgroups in order to have access to necessary in-depth technical expertise in the field of medical devices including in vitro diagnostic medical devices. When establishing subgroups, appropriate consideration should be given to the possibility of involving existing groups at Union level in the field of medical devices. (84) Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is essential for ensuring a uniform high level of health and safety protection within the internal market, in particular in the areas of performance studies and vigilance. The principle of coordinated exchange and assessment should also apply across other authority activities described in this Regulation, such as the designation of notified bodies and should be encouraged in the area of market surveillance of devices. Joint working, coordination and communication of activities should also lead to more efficient use of resources and expertise at national level. (85) The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly implemented at Union level based on sound scientific evidence. (86) The Union and, where appropriate, the Member States should actively participate in international regulatory cooperation in the field of devices to facilitate the exchange of safety-related information regarding devices and foster the further development of international regulatory guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that set by this Regulation. (87) Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement. (88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should, in order to ensure transparency, inform the Commission and the other Member States before they decide on the level and structure of such fees. In order to further ensure transparency, the structure and level of the fees should be publicly available on request. (89) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should be applied by the Member States in accordance with those rights and principles. (90) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in order to amend certain non-essential provisions of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making (17). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with preparation of delegated acts. (91) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (18). (92) The advisory procedure should be used for implementing acts that set out the form and presentation of the data elements of manufacturers' summaries of safety and performance, and that establish the model for certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an impact on health and safety at Union level. (93) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures, imperative grounds of urgency so require. (94) In order to enable it to designate issuing entities and EU reference laboratories, implementing powers should be conferred on the Commission. (95) To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements that are to be made. However, certain parts of the Regulation that directly affect Member States and the Commission should be implemented as soon as possible. It is also particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be designated in accordance with the new requirements so as to avoid any shortage of devices on the market. Nonetheless, it is necessary that any designation of a notified body in accordance with the requirements of this Regulation prior to the date of its application be without prejudice to the validity of the designation of those notified bodies under Directive 98/79/EC and to their capacity to continue issuing valid certificates under that Directive until the date of application of this Regulation. (96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the obligation to submit the relevant information to the electronic systems set up at Union level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to plan, only become fully effective from 18 months after the date of application of this Regulation. During this transitional period, certain provisions of Directive 98/79/EC should remain in force. However, in order to avoid multiple registrations, economic operators and notified bodies who register in the relevant electronic systems set up at Union level pursuant to this Regulation should be considered to be in compliance with the registration requirements adopted by the Member States pursuant to those provisions. (97) In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned. (98) Directive 98/79/EC should be repealed to ensure that only one set of rules applies to the placing of in vitro diagnostic medical devices on the market and the related aspects covered by this Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to that Directive should however continue to apply. While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting adverse incidents related to devices placed on the market pursuant to that Directive using the same tools as those for reporting on devices placed on the market pursuant to this Regulation. However, Decision 2010/227/EU adopted in implementation of that Directive and Council Directives 90/385/EEC (19) and 93/42/EEC (20) should also be repealed as from the date when Eudamed becomes fully functional. (99) The requirements of this Regulation should be applicable to all devices placed on the market or put into service from the date of application of this Regulation. However, in order to provide for a smooth transition it should be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by virtue of a valid certificate issued pursuant to Directive 98/79/EC. (100) The European Data Protection Supervisor has given an opinion (21) pursuant to Article 28(2) of Regulation (EC) No 45/2001. (101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal market as regards medical devices and to ensure high standards of quality and safety for in vitro diagnostic medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER I INTRODUCTORY PROVISIONS Section 1 Scope and definitions Article 1 Subject matter and scope 1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union. 2. For the purposes of this Regulation, in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices shall hereinafter be referred to as \u2018devices\u2019. 3. This Regulation does not apply to: (a) products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; (b) invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen; (c) internationally certified reference materials; (d) materials used for external quality assessment schemes. 4. Any device which, when placed on the market or put into service, incorporates, as an integral part, a medical device as defined in point 1 of Article 2 of Regulation (EU) 2017/745 shall be governed by that Regulation. The requirements of this Regulation shall apply to the in vitro diagnostic medical device part. 5. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU. 6. Devices which are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (22) shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation. 7. This Regulation shall not affect the application of Directive 2013/59/Euratom. 8. This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation. 9. This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or health care institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling. 10. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) \u2018medical device\u2019 means \u2018medical device\u2019 as defined in point (1) of Article 2 of Regulation (EU) 2017/745; (2) \u2018in vitro diagnostic medical device\u2019 means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices; (3) \u2018specimen receptacle\u2019 means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination; (4) \u2018accessory for an in vitro diagnostic medical device\u2019 means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s); (5) \u2018device for self-testing\u2019 means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services; (6) \u2018device for near-patient testing\u2019 means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional; (7) \u2018companion diagnostic\u2019 means a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product; (8) \u2018generic device group\u2019 means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics; (9) \u2018single-use device\u2019 means a device that is intended to be used during a single procedure; (10) \u2018falsified device\u2019 means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights; (11) \u2018kit\u2019 means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof; (12) \u2018intended purpose\u2019 means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation; (13) \u2018label\u2019 means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices; (14) \u2018instructions for use\u2019 means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken; (15) \u2018Unique Device Identifier\u2019 (\u2018UDI\u2019) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market; (16) \u2018risk\u2019 means the combination of the probability of occurrence of harm and the severity of that harm; (17) \u2018benefit-risk determination\u2019 means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer; (18) \u2018compatibility\u2019 is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to: (a) perform without losing or compromising the ability to perform as intended, and/or (b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or (c) be used together without conflict/interference or adverse reaction; (19) \u2018interoperability\u2019 is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to: (a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or (b) communicate with each other, and/or (c) work together as intended; (20) \u2018making available on the market\u2019 means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (21) \u2018placing on the market\u2019 means the first making available of a device, other than a device for performance study, on the Union market; (22) \u2018putting into service\u2019 means the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose; (23) \u2018manufacturer\u2019 means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark; (24) \u2018fully refurbishing\u2019, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device; (25) \u2018authorised representative\u2019 means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation; (26) \u2018importer\u2019 means any natural or legal person established within the Union that places a device from a third country on the Union market; (27) \u2018distributor\u2019 means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service; (28) \u2018economic operator\u2019 means a manufacturer, an authorised representative, an importer or a distributor; (29) \u2018health institution\u2019 means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health; (30) \u2018user\u2019 means any healthcare professional or lay person who uses a device; (31) \u2018lay person\u2019 means an individual who does not have formal education in a relevant field of healthcare or medical discipline; (32) \u2018conformity assessment\u2019 means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; (33) \u2018conformity assessment body\u2019 means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; (34) \u2018notified body\u2019 means a conformity assessment body designated in accordance with this Regulation; (35) \u2018CE marking of conformity\u2019 or \u2018CE marking\u2019 means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing; (36) \u2018clinical evidence\u2019 means clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer; (37) \u2018clinical benefit\u2019 means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health; (38) \u2018scientific validity of an analyte\u2019 means the association of an analyte with a clinical condition or a physiological state; (39) \u2018performance of a device\u2019 means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose; (40) \u2018analytical performance\u2019 means the ability of a device to correctly detect or measure a particular analyte; (41) \u2018clinical performance\u2019 means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user; (42) \u2018performance study\u2019 means a study undertaken to establish or confirm the analytical or clinical performance of a device; (43) \u2018performance study plan\u2019 means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study; (44) \u2018performance evaluation\u2019 means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device; (45) \u2018device for performance study\u2019 means a device intended by the manufacturer to be used in a performance study. A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study; (46) \u2018interventional clinical performance study\u2019 means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment; (47) \u2018subject\u2019 means an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes; (48) \u2018investigator\u2019 means an individual responsible for the conduct of a performance study at a performance study site; (49) \u2018diagnostic specificity\u2019 means the ability of a device to recognise the absence of a target marker associated with a particular disease or condition; (50) \u2018diagnostic sensitivity\u2019 means the ability of a device to identify the presence of a target marker associated with a particular disease or condition; (51) \u2018predictive value\u2019 means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition; (52) \u2018positive predictive value\u2019 means the ability of a device to separate true positive results from false positive results for a given attribute in a given population; (53) \u2018negative predictive value\u2019 means the ability of a device to separate true negative results from false negative results for a given attribute in a given population; (54) \u2018likelihood ratio\u2019 means the likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state; (55) \u2018calibrator\u2019 means a measurement reference material used in the calibration of a device; (56) \u2018control material\u2019 means a substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device; (57) \u2018sponsor\u2019 means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study; (58) \u2018informed consent\u2019 means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the performance study; (59) \u2018ethics committee\u2019 means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations; (60) \u2018adverse event\u2019 means any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study; (61) \u2018serious adverse event\u2019 means any adverse event that led to any of the following: (a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring, (b) death, (c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect; (62) \u2018device deficiency\u2019 means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer; (63) \u2018post-market surveillance\u2019 means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions; (64) \u2018market surveillance\u2019 means the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; (65) \u2018recall\u2019 means any measure aimed at achieving the return of a device that has already been made available to the end user; (66) \u2018withdrawal\u2019 means any measure aimed at preventing a device in the supply chain from being further made available on the market; (67) \u2018incident\u2019 means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device; (68) \u2018serious incident\u2019 means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat; (69) \u2018serious public health threat\u2019 means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time; (70) \u2018corrective action\u2019 means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation; (71) \u2018field safety corrective action\u2019 means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; (72) \u2018field safety notice\u2019 means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action; (73) \u2018harmonised standard\u2019 means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012; (74) \u2018common specifications\u2019 (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. Section 2 Regulatory status of products and counselling Article 3 Regulatory status of products 1. Upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of Regulation (EU) 2017/745 (MDCG), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of \u2018in vitro diagnostic medical device\u2019 or \u2018accessory for an in vitro diagnostic medical device\u2019. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3) of this Regulation. 2. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 3. The Commission shall ensure that Member States share expertise in the fields of in vitro diagnostic medical devices, medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products. 4. When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant. Article 4 Genetic information, counselling and informed consent 1. Member States shall ensure that where a genetic test is used on individuals, in the context of healthcare as defined in point (a) of Article 3 of Directive 2011/24/EU of the European Parliament and of the Council (23) and for the medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing, the individual being tested or, where applicable, his or her legally designated representative is provided with relevant information on the nature, the significance and the implications of the genetic test, as appropriate. 2. In the context of the obligations referred to in paragraph 1, Member States shall, in particular, ensure that there is appropriate access to counselling in the case of the use of genetic tests that provide information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable according to the state of science and technology. 3. Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease which the individual being tested is already known to have is confirmed by a genetic test or in cases where a companion diagnostic is used. 4. Nothing in this Article shall prevent Member States from adopting or maintaining measures at national level which are more protective of patients, more specific or which deal with informed consent. CHAPTER II MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE MARKING, FREE MOVEMENT Article 5 Placing on the market and putting into service 1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose. 2. A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose. 3. Demonstration of conformity with the general safety and performance requirements shall include a performance evaluation in accordance with Article 56. 4. Devices that are manufactured and used within health institutions, with the exception of devices for performance studies, shall be considered as having been put into service. 5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met: (a) the devices are not transferred to another legal entity; (b) manufacture and use of the devices occur under appropriate quality management systems; (c) the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation; (d) the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market; (e) the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use; (f) the health institution draws up a declaration which it shall make publicly available, including: (i) the name and address of the manufacturing health institution, (ii) the details necessary to identify the devices, (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor; (g) as regards class D devices in accordance with the rules set out in Annex VIII, the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met. Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII; (h) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g); and (i) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions. Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions. This paragraph shall not apply to devices that are manufactured on an industrial scale. 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 6 Distance sales 1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation. 2. Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation. 3. Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned. 4. A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity. Article 7 Claims In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: (a) ascribing functions and properties to the device which the device does not have; (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; (d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out. Article 8 Use of harmonised standards 1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, performance studies, clinical evidence or post-market performance follow-up (\u2018PMPF\u2019). References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union. 2. References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, provided that references to those monographs have been published in the Official Journal of the European Union. Article 9 Common specifications 1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the performance evaluation and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annex XIII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS. 3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto. Article 10 General obligations of manufacturers 1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation. 2. Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. 3. Manufacturers shall conduct a performance evaluation in accordance with the requirements set out in Article 56 and Annex XIII, including a PMPF. 4. Manufacturers shall draw up and keep up to date the technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress, the Annexes II and III. 5. Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devices for performance study, shall draw up an EU declaration of conformity in accordance with Article 17, and affix the CE marking of conformity in accordance with Article 18. 6. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 24 and with the registration obligations referred to in Article 26 and 28. 7. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof. A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available. 8. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a product is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than devices for performance study, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device. The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation. The quality management system shall address at least the following aspects: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system; (b) identification of applicable general safety and performance requirements and exploration of options to address those requirements; (c) responsibility of the management; (d) resource management, including selection and control of suppliers and sub-contractors; (e) risk management as set out in Section 3 of Annex I; (f) performance evaluation, in accordance with Article 56 and Annex XIII, including PMPF; (g) product realisation, including planning, design, development, production and service provision; (h) verification of the UDI assignments made in accordance with Article 24(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 26; (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 78; (j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders; (k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance; (l) management of corrective and preventive actions and verification of their effectiveness; (m) processes for monitoring and measurement of output, data analysis and product improvement. 9. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 78. 10. Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient. The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing shall be easily understandable and provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient. 11. Manufacturers that consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly. Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 51, in particular, of the non-compliance and of any corrective action taken. 12. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 82 and 83. 13. Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned. The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service. If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information. If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights. The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings. 14. Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 27(1). 15. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law. Article 11 Authorised representative 1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. 2. The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group. 3. The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request. The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer; (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, at the disposal of competent authorities for the period referred to in Article 10(7); (c) comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied with the registration obligations laid down in Article 26; (d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned; (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device; (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices; (g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated; (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation. 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11). 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. 6. An authorised representative who terminates its mandate on the grounds referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor. 7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business. Article 12 Change of authorised representative The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects: (a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative; (b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material; (c) the transfer of documents, including confidentiality aspects and property rights; (d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative. Article 13 General obligations of importers 1. Importers shall place on the Union market only devices that are in conformity with this Regulation. 2. In order to place a device on the market, importers shall verify that: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up; (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer; (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use; (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24. Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established. 3. Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer. 4. Importers shall verify that the device is registered in the electronic system in accordance with Article 26. Importers shall add their details to the registration in accordance with Article 28. 5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available. 6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints. 7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it, is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 51 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken. 8. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative. 9. Importers shall, for the period referred to in Article 10(7), keep a copy of the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51. 10. Importers shall cooperate with competent authorities, at the latters' request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device. Article 14 General obligations of distributors 1. When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable. 2. Before making a device available on the market, distributors shall verify that all of the following requirements are met: (a) the device has been CE marked and the EU declaration of conformity of the device has been drawn up; (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(10); (c) for imported devices, the importer has complied with the requirements set out in Article 13(3); (d) that, where applicable, a UDI has been assigned by the manufacturer. In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor. Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established. 3. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer. 4. Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable the manufacturer's authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. 5. Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request. 6. Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device. Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device. Article 15 Person responsible for regulatory compliance 1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices. The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices; (b) four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (24) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal. 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(9); (d) the reporting obligations referred to in Articles 82 to 86 are fulfilled; (e) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued. 4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing. 5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation. 6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for in vitro diagnostic medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices; (b) four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons 1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following: (a) makes available on the market a device under its own name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation; (b) changes the intended purpose of a device already placed on the market or put into service; (c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (23) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose. 2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements: (a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 20 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State; (b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging. 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established. Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation. 4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities referred to in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or a mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3. Article 17 EU declaration of conformity 1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available. 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device. The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates. 3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device. 4. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress. Article 18 CE marking of conformity 1. Devices, other than devices for performance studies, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V. 2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. 3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging. 4. The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use. 5. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 48. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking. 6. Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation. Article 19 Devices for special purposes 1. Member States shall not create obstacles to devices for performance study being supplied for that purpose to laboratories or other institutions, if they meet the conditions laid down in Articles 57 to 76, and in the implementing acts adopted pursuant to Article 77. 2. The devices referred to in paragraph 1 shall not bear the CE marking, with the exception of the devices referred to in Article 70. 3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided that a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation. Article 20 Parts and components 1. Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States. 2. An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation. Article 21 Free movement Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation. CHAPTER III IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES Article 22 Identification within the supply chain 1. Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices. 2. Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(7): (a) any economic operator to whom they have directly supplied a device; (b) any economic operator who has directly supplied them with a device; (c) any health institution or healthcare professional to which they have directly supplied a device. Article 23 Medical devices nomenclature To facilitate the functioning of the European database on medical devices (Eudamed) as referred to in Article 33 of Regulation (EU) 2017/745, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable. Article 24 Unique Device Identification system 1. The Unique Device Identification system (\u2018UDI system\u2019) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than devices for performance studies, and shall consist of the following: (a) production of a UDI that comprises the following: (i) a UDI device identifier (\u2018UDI-DI\u2019) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI; (ii) a UDI production identifier (\u2018UDI-PI\u2019) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI; (b) placing of the UDI on the label of the device or on its packaging; (c) storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 respectively; (d) establishment of an electronic system for Unique Device Identification (\u2018UDI database\u2019) in accordance with Article 28 of Regulation (EU) 2017/745. 2. The Commission shall, by means of implementing acts, designate one or several entities to operate a system for assignment of UDIs pursuant to this Regulation (\u2018issuing entity\u2019). That entity or those entities shall satisfy all of the following criteria: (a) the entity is an organisation with legal personality; (b) its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation; (c) its system for the assignment of UDIs conforms to the relevant international standards; (d) the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions; (e) the entity undertakes to do the following: (i) operate its system for the assignment of UDIs for at least 10 years after its designation; (ii) make available to the Commission and to the Member States, upon request, information concerning its system for the assignment of UDIs; (iii) remain in compliance with the criteria for designation and the terms of designation. When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to minimising financial and administrative burdens for economic operators, health institutions and healthcare professionals. 3. Before placing a device, other than a device for performance study, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2. Before a device, other than a device for performance study, is placed on the market the manufacturer must ensure that the information referred to in Part B of Annex V of the device in question are correctly submitted and transferred to the UDI database referred to in Article 25. 4. UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers. 5. The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 82. 6. The Basic UDI-DI, as defined in Part C of Annex VI of the device shall appear on the EU declaration of conformity referred to in Article 17. 7. As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned. 8. Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11. 9. Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied. Member States shall encourage, and may require, health care professionals to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied with. 10. The Commission is empowered to adopt delegated acts in accordance with Article 108: (a) amending the list of information set out in Part B of Annex VI in the light of technical progress; and (b) amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification. 11. The Commission may, by means of implementing acts, specify the detailed arrangements and the procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the following: (a) determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply; (b) specifying the data to be included in the UDI-PI of specific devices or device groups. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3). 12. When adopting the measures referred to in paragraph 11, the Commission shall take into account all of the following: (a) confidentiality and data protection as referred to in Articles 102 and 103 respectively; (b) the risk-based approach; (c) the cost-effectiveness of the measures; (d) the convergence of UDI systems developed at international level; (e) the need to avoid duplications in the UDI system; (f) the needs of the health care systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders. Article 25 UDI database The Commission, after consulting the MDCG, shall set up and manage a UDI database in accordance with the conditions and detailed arrangements provided for in Article 28 of Regulation (EU) 2017/745. Article 26 Registration of devices 1. Before placing a device on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 24(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device. 2. For devices that are the subject of a conformity assessment as referred to in Article 48(3) and (4), the second subparagraph of Article 48(7), Article 48(8) and the second subparagraph of Article 48(9), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment. For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device. 3. Before placing a device on the market, the manufacturer shall enter or, if already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and thereafter shall keep the information updated. Article 27 Electronic system for registration of economic operators 1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 28(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative and the importer. The details regarding the information to be provided to that electronic system by the economic operators are laid down in Section 1 of Part A of Annex VI. 2. Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory. 3. Within two weeks of placing a device on the market, importers shall verify that the manufacturer or authorised representative has provided to the electronic system the information referred to in paragraph 1. Where applicable, importers shall inform the relevant authorised representative or manufacturer if the information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the relevant entry/entries. Article 28 Registration of manufacturers, authorised representatives and importers 1. Before placing a device on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 48, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body. 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (\u2018SRN\u2019) from the electronic system referred to in Article 27 and issue it to the manufacturer, the authorised representative or the importer. 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 26. 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 27. 5. Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation. 6. Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI. 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 27 shall be accessible to the public. 8. The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 104. Article 29 Summary of safety and performance 1. For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary of safety and performance. The summary of safety and performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available. 2. The summary of safety and performance shall include at least the following aspects: (a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN; (b) the intended purpose of the device and any indications, contra-indications and target populations; (c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device; (d) reference to any harmonised standards and CS applied; (e) the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF; (f) the metrological traceability of assigned values; (g) suggested profile and training for users; (h) information on any residual risks and any undesirable effects, warnings and precautions. 3. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2). Article 30 European database on medical devices 1. The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (\u2018Eudamed\u2019) in accordance with the conditions and detailed arrangements established by Articles 33 and 34 of Regulation (EU) 2017/745. 2. Eudamed shall include the following electronic systems: (a) the electronic system for registration of devices referred to in Article 26; (b) the UDI database referred to in Article 25; (c) the electronic system on registration of economic operators referred to in Article 27; (d) the electronic system on notified bodies and on certificates referred to in Article 52; (e) the electronic system on performance studies referred to in Article 69, (f) the electronic system on vigilance and post-market surveillance referred to in Article 87; (g) the electronic system on market surveillance referred to in Article 95. CHAPTER IV NOTIFIED BODIES Article 31 Authorities responsible for notified bodies 1. Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (the \u2018authority responsible for notified bodies\u2019), which may consist of separate constituent entities under national law and shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors and subsidiaries of those bodies. 2. The authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with conformity assessment bodies. 3. The authority responsible for notified bodies shall be organised in a manner such that each decision relating to designation or notification is taken by personnel different from those who carried out the assessment. 4. The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis. 5. The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains. However, it shall exchange information on notified bodies with other Member States, the Commission and, when required, with other regulatory authorities. 6. The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks. Where the authority responsible for notified bodies is a different authority from the national competent authority for in vitro diagnostic medical devices, it shall ensure that the national authority responsible for in vitro diagnostic medical devices is consulted on relevant matters. 7. Member States shall make publicly available general information on their measures governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and on changes which have a significant impact on such tasks. 8. The authority responsible for notified bodies shall participate in peer-review activities provided for in Article 44. Article 32 Requirements relating to notified bodies 1. Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex VII. In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII, and personnel with relevant clinical expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself. The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors. 2. Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter. 3. In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 33 Subsidiaries and subcontracting 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly. 2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries. 3. Notified bodies shall make publicly available a list of their subsidiaries. 4. Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly. 5. Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation. Article 34 Application by conformity assessment bodies for designation 1. Conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies. 2. The application shall specify the conformity assessment activities as defined in this Regulation, and the types of devices for which the body is applying to be designated, and shall be supported by documentation demonstrating compliance with Annex VII. In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 35. However, the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request. 3. The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements set out in Annex VII. Article 35 Assessment of the application 1. The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 34 is complete and shall request the applicant to provide any missing information. Once the application is complete that national authority shall send it to the Commission. The authority responsible for notified bodies shall review the application and supporting documentation in accordance with its own procedures and shall draw up a preliminary assessment report. 2. The authority responsible for notified bodies shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the MDCG. 3. Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific circumstances require a different number of experts, chosen from the list referred to in Article 36. One of the experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team. The other two experts shall come from Member States other than the one in which the applicant conformity assessment body is established. The joint assessment team shall be comprised of competent experts who are competent to assess the conformity assessment activities and the types of devices which are the subject of the application or, in particular when the assessment procedure is initiated in accordance with Article 43(3) to ensure that the specific concern can be appropriately assessed. 4. Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 34. The joint assessment team may provide feedback to, or require clarification from, the authority responsible for notified bodies on the application and on the planned on-site assessment. The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to be involved in the conformity assessment process. The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies. 5. Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VII shall be raised during the assessment process and discussed between the authority responsible for notified bodies and the joint assessment team with a view to reaching consensus and resolving any diverging opinions, with respect to the assessment of the application. At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant conformity assessment body the non-compliances resulting from the assessment and summarise of the assessment by the joint assessment team. Within a specified timeframe, the applicant conformity assessment body shall submit to the national authority a corrective and preventive action plan to address the non-compliances. 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies. 7. The authority responsible for notified bodies shall, following receipt of a corrective and preventive action plan from the applicant body, assess whether non-compliances identified during the assessment have been appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein. The authority responsible for notified bodies shall, having confirmed the corrective and preventive action plan, forward it and its opinion thereon to the joint assessment team. The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications. The authority responsible for notified bodies shall draw up its final assessment report which shall include: \u2014 the result of the assessment, \u2014 confirmation that the corrective and preventive actions have been appropriately addressed and, where required, implemented, \u2014 any remaining diverging opinion with the joint assessment team, and, where applicable, \u2014 the recommended scope of designation. 8. The authority responsible for notified bodies shall submit its final assessment report and, if applicable, the draft designation to the Commission, the MDCG and the joint assessment team. 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those documents to the Commission which shall immediately submit that final opinion to the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft designation, which the authority responsible for notified bodies shall duly take into consideration for its decision on the designation of the notified body. 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements specifying procedures and reports for the application for designation referred to in Article 34 and the assessment of the application set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 36 Nomination of experts for joint assessment of applications for notification 1. The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of in vitro diagnostic medical devices to participate in the activities referred to in Articles 35 and 44. 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise. That list shall be made available to Member States competent authorities through the electronic system referred to in Article 52. Article 37 Language requirements All documents required pursuant to Articles 34 and 35 shall be drawn up in a language or languages which shall be determined by the Member State concerned. Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned. The Commission shall provide translations of the documentation pursuant to Articles 34 and 35, or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 35(3). Article 38 Designation and notification procedure 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 35 was completed and which comply with Annex VII. 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool within the database of notified bodies developed and managed by the Commission (NANDO). 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope of the designation indicating the conformity assessment activities as defined in this Regulation, and the types of devices which the notified body is authorised to assess and, without prejudice to Article 40, any conditions associated with the designation. 4. The notification shall be accompanied by the final assessment report of the authority responsible for notified bodies, the final opinion of the joint assessment team referred to in Article 35(9) and the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification. 5. The notifying Member State shall, without prejudice to Article 40, inform the Commission and the other Member States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set out in Annex VII. 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission may raise written objections, setting out its arguments, with regard either to the notified body or to its monitoring by the authority responsible for notified bodies. Where no objection is raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in paragraph 2. 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter having been brought before it. Where the MDCG is of the opinion that the notification can be accepted, the Commission shall publish in NANDO the notification within 14 days. 8. Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40 days of its receipt. The response shall address the objections raised in the opinion, and set out the reasons for the notifying Member State's decision to designate or not designate the conformity assessment body. 9. Where the notifying Member State decides to uphold its decision to designate the conformity assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notification within 14 days of being informed thereof. 10. When publishing the notification in NANDO, the Commission shall add to the electronic system referred to in Article 52 the information relating to the notification of the notified body along with the documents mentioned in paragraph 4 of this Article and the opinion and response referred to in paragraphs 7 and 8 of this Article. 11. The designation shall become valid the day after the notification is published in NANDO. The published notification shall state the scope of lawful conformity assessment activity of the notified body. 12. The conformity assessment body concerned may perform the activities of a notified body only after the designation has become valid in accordance with paragraph 11. 13 The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). The Commission, after consulting the MDCG, may update this list based, inter alia, on information arising from the coordination activities described in Article 44. Article 39 Identification number and list of notified bodies 1. The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 38(11). It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directive 98/79/EC shall retain the identification number assigned to them pursuant to that Directive. 2. The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in Article 52. The Commission shall ensure that the list is kept up to date. Article 40 Monitoring and re-assessment of notified bodies 1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated. 2. The authorities responsible for notified bodies shall monitor the notified bodies established on their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its obligations set out in this Regulation. Notified bodies shall, upon request by their authority responsible for notified bodies, supply all relevant information and documents, required to enable the authority, the Commission and other Member States to verify compliance. 3. Where the Commission or the authority of a Member State submits a request to a notified body established on the territory of another Member State relating to a conformity assessment carried out by that notified body, it shall send a copy of that request to the authority responsible for notified bodies of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The authority responsible for notified bodies of the Member State in which the body is established shall ensure that requests submitted by authorities of any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason for not doing so in which case the matter may be referred to the MDCG. 4. At least once a year, the authorities responsible for notified bodies shall re-assess whether the notified bodies established on their respective territory and, where appropriate, the subsidiaries and subcontractors under the responsibility of those notified bodies still satisfy the requirements and fulfil their obligations set out in Annex VII. That review shall include an on-site audit of each notified body and, where necessary, of its subsidiaries and subcontractors. The authority responsible for notified bodies shall conduct its monitoring and assessment activities according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular, associated subsidiaries and subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission. 5. The monitoring of notified bodies by the authority responsible for notified bodies shall include observed audits of notified body personnel, including where necessary any personnel from subsidiaries and subcontractors, as that personnel in the process of conducting quality management system assessments at a manufacturer's facility. 6. The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider data arising from market surveillance, vigilance and post-market surveillance to help guide its activities. The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and other information, including from other Member States, which may indicate non-fulfilment of the obligations by a notified body or its deviation from common or best practice. 7. The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments conduct short-notice, unannounced or \u2018for-cause\u2019 reviews if needed to address a particular issue or to verify compliance. 8. The authority responsible for notified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the performance evaluation documentation as further outlined in Article 41. 9. The authority responsible for notified bodies shall document and record any findings regarding non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective and preventive actions. 10. Three years after notification of a notified body, and again every fourth year thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team appointed for the purpose of the procedure described in Articles 34 and 35. 11. The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to amend paragraph 10 of this Article to modify the frequency at which the complete re-assessment referred to in that paragraph is to be carried out. 12. The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however, it shall contain a summary which shall be made publicly available. The summary of the report shall be uploaded to the electronic system referred to in Article 52. Article 41 Review of notified body assessment of technical documentation and performance evaluation documentation 1. The authority responsible for notified bodies, as part of its ongoing monitoring of notified bodies, shall review an appropriate number of notified body assessments of manufacturers' technical documentation, in particular the performance evaluation documentation to verify the conclusions drawn by the notified body based on the information presented by the manufacturer. The reviews by the authority responsible for notified bodies shall be conducted both off-site and on-site. 2. The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the types and risk of devices certified by the notified body, in particular high-risk devices, and be appropriately justified and documented in a sampling plan, which shall be made available by the authority responsible for notified bodies to the MDCG upon request. 3. The authority responsible for notified bodies shall review whether the assessment by the notified body was conducted appropriately and shall check the procedures used, associated documentation and the conclusions drawn by the notified body. Such checking shall include the technical documentation and performance evaluation documentation of the manufacturer upon which the notified body has based its assessment. Such reviews shall be conducted utilising CS. 4. Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 40(10) and the joint assessment activities referred to in Article 43(3). The reviews shall be conducted utilising appropriate expertise. 5. Based on the reports of the reviews and assessments by the authority responsible for notified bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market surveillance activities described in Chapter VII, or on the continuous monitoring of technical progress, or on the identification of concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that the sampling carried out under this Article cover a greater or lesser proportion of the technical documentation and performance evaluation documentation assessed by a notified body. 6. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and performance evaluation documentation, as referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 42 Changes to designations and notifications 1. The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body. The procedures described in Article 35 and in Article 38 shall apply to extensions of the scope of the designation. For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply. 2. The Commission shall immediately publish the amended notification in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 52. 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation. 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period. The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation. 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days. 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request. 7 In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall: (a) assess the impact on the certificates issued by the notified body; (b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation; (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market; (d) enter in the electronic system referred to in Article 52 information in relation to certificates of which it has required their suspension or withdrawal; (e) inform the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 52 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others. 8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor, and remain responsible for, existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction. 9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances: (a) where the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and (b) another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation. In the circumstances referred to in the first subparagraph, the national competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months. The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof. Article 43 Challenge to the competence of notified bodies 1. The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in Annex VII or the obligations to which they are subject. It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns. 2. The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned. 3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described in Article 35(3) and (5) where there is reasonable concern about the ongoing compliance of a notified body or a subsidiary or subcontractor of the notified body with the requirements set out in Annex VII and where the investigation by the authority responsible for notified bodies is not deemed to have fully addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome of that assessment shall follow the principles of Article 35. Alternatively, depending on the severity of the issue, the Commission, in conjunction with the MDCG, may request that the authority responsible for notified bodies allow the participation of up to two experts from the list established pursuant to Article 36 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 40 and as outlined in the annual assessment plan described in Article 40(4) therein. 4. Where the Commission ascertains that a notified body no longer meets the requirements for its designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the designation if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the designation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 52. 5. The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly. Article 44 Peer review and exchange of experience between authorities responsible for notified bodies 1. The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements including: (a) development of best practice documents relating to the activities of the authorities responsible for notified bodies; (b) development of guidance documents for notified bodies in relation to the implementation of this Regulation; (c) training and qualification of the experts referred to in Article 36; (d) monitoring of trends relating to changes to notified body designations and notifications, and trends in certificate withdrawals and transfers between notified bodies; (e) monitoring of the application and applicability of scope codes referred to in Article 38(13); (f) development of a mechanism for peer reviews between authorities and the Commission; (g) methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies. 2. The authorities responsible for notified bodies shall participate in a peer review every third year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 35. Alternatively, a national authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 40. 3. The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism. 4. The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available. 5. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanisms and training and qualification as referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 45 Coordination of notified bodies The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies, as referred to in Article 49 of Regulation (EU) 2017/745. The bodies notified under this Regulation shall participate in the work of that group. Article 46 List of standard fees Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available. CHAPTER V CLASSIFICATION AND CONFORMITY ASSESSMENT Section 1 Classification Article 47 Classification of devices 1. Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII. 2. Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2. of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body. The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request. 3. At the request of a Member State, the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices; (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII. 4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3. 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 107(3). Section 2 Conformity assessment Article 48 Conformity assessment procedures 1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 2. Prior to putting into service a device that is not placed on the market, with the exception of in-house devices manufactured pursuant to Article 5(5), manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 3. Manufacturers of class D devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I, II except for Section 5, and in Chapter III of Annex IX. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council (25) or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 4. Manufacturers of class D devices, other than devices for performance study, may, instead of the conformity assessment procedure applicable pursuant to paragraph 3, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI. For companion diagnostics, the notified body shall in particular consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 5. In particular, and without prejudice to any of the obligations pursuant to the other procedures referred to in paragraphs 3 and 4, for devices for which one or more EU reference laboratories have been designated in accordance with Article 100, the notified body performing the conformity assessment shall request one of the EU reference laboratories to verify by laboratory testing the performance claimed by the manufacturer and the compliance of the device with the applicable CS, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 4.9 of Annex IX and in point (j) of Section 3 of Annex X. Laboratory tests performed by an EU reference laboratory shall in particular focus on analytical and diagnostic sensitivity using the best available reference materials. 6. In addition to the procedure applicable pursuant to paragraphs 3 and 4, where no CS are available for class D devices and where it is also the first certification for that type of device, the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer. To that end, the notified body shall provide the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the manufacturer. The relevant experts shall, under the supervision of the Commission, provide their views, in accordance with Section 4.9 of Annex IX or point (j) of Section 3 of Annex X, as applicable, to the notified body within the deadline for delivery of the scientific opinion by the EU reference laboratory as specified therein. 7. Manufacturers of class C devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex of at least one representative device per generic device group. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 8. Manufacturers of class C devices, other than devices for performance study, may, instead of the conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5. For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 9. Manufacturers of class B devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex for at least one representative device per category of devices. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out in Section 5.1 of Annex IX. 10. Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III. However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions. 11. Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77. 12. The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 10 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body. 13. The Commission may, by means of implementing acts, specify the detailed arrangements and procedural aspects with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies, for any of the following aspects: (a) the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in third paragraph of Section 2.3. and in Section 3.5 of Annex IX, in the case of class C devices; (b) the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device; (c) the frequency of samples of the manufactured devices or batches of class D devices to be sent to an EU reference laboratory designated under Article 100 in accordance with Section 4.12 of Annex IX and Section 5.1 of Annex XI; or (d) the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX and points (f) and (g) of Section 3. of Annex X. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 49 Involvement of notified bodies in conformity assessment procedures 1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure. 2. The notified body concerned shall, by means of the electronic system referred to in Article 52, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body's decision regarding the conformity assessment. 3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn an application with another notified body prior to the decision of that notified body and provide information about any previous application for the same conformity assessment that has been refused by another notified body. 4. The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure. 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities. Article 50 Mechanism for scrutiny of conformity assessments of class D devices 1. A notified body shall notify the competent authority of certificates it has granted for class D devices, with the exception of applications to supplement or renew existing certificates. Such notification shall take place through the electronic system referred to in Article 52 and shall include the instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106 of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a full justification shall also be included. 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in accordance with to Articles 90 and 92. 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device. Article 51 Certificates of conformity 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates shall be as set out in Annex XII. 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid. 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or users or require manufacturers to undertake specific PMPF studies pursuant to Part B of Annex XIII. 4. Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision. 5. The notified body shall enter in the electronic system referred to in Article 52 any information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. Such information shall be accessible to the public. 6. In the light of technical progress, the Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the certificates set out in Annex XII. Article 52 Electronic system on notified bodies and on certificates of conformity For the purposes of this Regulation, the following information shall be collated and processed pursuant to Article 57 of Regulation (EU) 2017/745 in the electronic system set up in accordance with that Article: (a) the list of subsidiaries referred to in Article 33(2); (b) the list of experts referred to in Article 36(2); (c) the information relating to the notification referred to in Article 38(10) and the amended notifications referred to in Article 42(2); (d) the list of notified bodies referred to in Article 39(2); (e) the summary of the report referred to in Article 40(12); (f) the notifications for conformity assessments and certificates referred to in Article 50(1); (g) withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and Section 4.3 of Annex VII; (h) the information regarding certificates referred to in Article 51(5); (i) the summary of safety and performance referred to in Article 29. Article 53 Voluntary change of notified body 1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects: (a) the date on which the certificates issued by the outgoing notified body become invalid; (b) the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material; (c) the transfer of documents, including confidentiality aspects and property rights; (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body; (e) the last serial number or lot number for which the outgoing notified body is responsible. 2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid. Article 54 Derogation from the conformity assessment procedures 1. By way of derogation from Article 48, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service, within the territory of the Member State concerned, of a specific device for which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety or health. 2. The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient. 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 107(4). Article 55 Certificate of free sale 1. For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE-marking in accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 26. Where a notified body has issued a certificate pursuant to Article 51, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII. 2. The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2). CHAPTER VI CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES Article 56 Performance evaluation and clinical evidence 1. Confirmation of conformity with relevant general safety and performance requirements set out in Annex I, in particular those concerning the performance characteristics referred to in Chapter I and Section 9 of Annex I, under the normal conditions of the intended use of the device, and the evaluation of the interference(s) and cross-reaction(s) and of the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I, shall be based on scientific validity, analytical and clinical performance data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III. The manufacturer shall specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose. To that end, manufacturers shall plan, conduct and document a performance evaluation in accordance with this Article and with Part A of Annex XIII. 2. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan. 3. A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of the following, in accordance with this Article and with Part A of Annex XIII: (a) scientific validity; (b) analytical performance; (c) clinical performance. The data and conclusions drawn from the assessment of those elements shall constitute the clinical evidence for the device. The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance, that the relevant general safety and performance requirements set out in Annex I, are fulfilled, under normal conditions of use. 4. Clinical performance studies in accordance with Section 2 of Part A of Annex XIII shall be carried out unless it is duly justified to rely on other sources of clinical performance data. 5. The scientific validity data, the analytical performance data and the clinical performance data, their assessment and the clinical evidence derived therefrom, shall be documented in the performance evaluation report referred to in Section 1.3.2 of Part A of Annex XIII. The performance evaluation report shall be part of the technical documentation, referred to in Annex II, relating to the device concerned. 6. The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer's PMPF plan in accordance with Part B of Annex XIII and the post-market surveillance plan referred to in Article 79. The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually, with the data referred to in the first subparagraph. The summary of safety and performance referred to in Article 29(1) shall be updated as soon as possible, where necessary. 7. Where necessary to ensure the uniform application of Annex XIII, the Commission may, having due regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 57 General requirements regarding performance studies 1. The manufacturer shall ensure that a device for performance study complies with the general safety and performance requirements set out in Annex I apart from the aspects covered by the performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons. 2. Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device. 3. Performance studies shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all other interests and the data generated are scientifically valid, reliable and robust. Performance studies, including performance studies that use left-over samples, shall be conducted in accordance with applicable law on data protection. Article 58 Additional requirements for certain performance studies 1. Any performance study: (a) in which surgically invasive sample-taking is done only for the purpose of the performance study; (b) that is an interventional clinical performance study as defined in point (46) of Article 2; or (c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies, shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised, conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV. 2. Performance studies involving companion diagnostics shall be subject to the same requirements as the performance studies listed in paragraph 1. This does not apply to performance studies involving companion diagnostics using only left-over samples. Such studies shall however be notified to the competent authority. 3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study. At least one lay person shall participate in the ethical review. 4. Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor. Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that performance study who shall be the addressee for all communications with the sponsor provided for in this Regulation. 5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the performance study is the subject of an authorisation by the Member State(s) in which the performance study is to be conducted, in accordance with this Regulation, unless otherwise stated; (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the performance study, which is valid for that entire Member State under its national law; (c) the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union; (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64; (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored; (f) the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent, in accordance with Article 59; (g) the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need; (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded; (i) the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the performance study plan and constantly monitored; (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, any other person entitled by national law to provide the relevant patient care under performance study conditions; (k) no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the performance study; (l) where appropriate, biological safety testing reflecting the latest scientific knowledge or any other test deemed necessary in the light of the device's intended purpose has been conducted; (m) in the case of clinical performance studies, the analytical performance has been demonstrated, taking into consideration the state of the art; (n) in the case of interventional clinical performance studies, the analytical performance and scientific validity has been demonstrated, taking into consideration the state of the art. Where, for companion diagnostics, the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided; (o) the technical safety of the device with regard to its use has been proven, taking into consideration the state of the art as well as provisions in the field of occupational safety and accident prevention; (p) the requirements of Annex XIV are fulfilled. 6. Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the performance study at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal. 7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks. 8. Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used. Article 59 Informed consent 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2. Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent document. The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent has been given. The informed consent shall be documented. Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the performance study. 2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall: (a) enable the subject or his or her legally designated representative to understand: (i) the nature, objectives, benefits, implications, risks and inconveniences of the performance study; (ii) the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the performance study at any time without any resulting detriment and without having to provide any justification; (iii) the conditions under which the performance study is to be conducted, including the expected duration of the subject's participation in the performance study; and (iv) the possible treatment alternatives, including the follow-up measures if the participation of the subject in the performance study is discontinued; (b) be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative; (c) be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law; and (d) include information about the applicable damage compensation system referred to in Article 65; (e) include the Union-wide unique single identification number for the performance study referred to in Article 66(1) and information about the availability of the performance study results in accordance with paragraph 6 of this Article. 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative. 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information. 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information. 6. The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be made available pursuant to Article 73(5) in the electronic system on performance studies referred to in Article 69, irrespective of the outcome of the performance study, and shall be informed, to the extent possible, when they have become available. 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a performance study. Article 60 Performance studies on incapacitated subjects 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met: (a) the informed consent of their legally designated representative has been obtained; (b) the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in view of their capacity to understand it; (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator; (d) no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study; (e) the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods; (f) the performance study relates directly to a medical condition from which the subject suffers; (g) there are scientific grounds for expecting that participation in the performance study will produce: (i) a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or (ii) some benefit for the population represented by the incapacitated subject concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition. 2. The subject shall as far as possible take part in the informed consent procedure. 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved. Article 61 Performance studies on minors 1. A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met: (a) the informed consent of their legally designated representative has been obtained; (b) the minors have received the information referred to in Article 59(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children; (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator; (d) no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study; (e) the performance study is intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods; (f) the performance study either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors; (g) there are scientific grounds for expecting that participation in the performance study will produce: (i) a direct benefit to the minor subject outweighing the risks and burdens involved; or (ii) some benefit for the population represented by the minor concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor's condition; (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity; (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined in the national law, his or her express informed consent shall be obtained before that subject can continue to participate in the performance study. 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on minors, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved. Article 62 Performance studies on pregnant or breastfeeding women A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met: (a) the performance study has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved; (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if: (i) a performance study of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding; (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth; (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child; (d) no incentives or financial inducements are given to subjects, except for compensation for expenses and loss of earnings directly related to the participation in the performance study. Article 63 Additional national measures Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance studies, or persons in residential care institutions. Article 64 Performance studies in emergency situations 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information on the performance studies may be given, after the decision to include the subject in the performance study, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical performance study plan for that performance study and that all of the following conditions are fulfilled: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the performance study; (b) there are scientific grounds to expect that participation of the subject in the performance study will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition; (c) it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative; (d) the investigator certifies that he or she is not aware of any objections to participate in the performance study previously expressed by the subject; (e) the performance study relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the performance study is of such a nature that it may be conducted exclusively in emergency situations; (f) the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition. 2. Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article 59 shall be sought to continue the participation of the subject in the performance study, and information on the performance study shall be given, in accordance with the following requirements: (a) regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 59(2) shall be given as soon as possible to the subject and to his or her legally designated representative; (b) regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever can be done sooner, and the information referred to in Article 59(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable. For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the performance study shall be obtained from the subject as soon as he or she is capable of giving informed consent. 3. If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object to the use of data obtained from the performance study. Article 65 Damage compensation 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a performance study conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk. 2. The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State in which the performance study is conducted. Article 66 Application for performance studies 1. The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an application to the Member State(s) in which the performance study is to be conducted (referred to for the purposes of this Article as \u2018Member State concerned\u2019) accompanied by the documentation referred to in Sections 2 and 3 of Annex XIII and in Annex XIV. The application shall be submitted by means of the electronic system referred to in Article 69, which shall generate a Union-wide unique single identification number for the performance study which shall be used for all relevant communication in relation to that performance study. Within 10 days of receiving the application, the Member State concerned shall notify the sponsor as to whether the performance study falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I of Annex XIV. 2. Within one week of any change occurring in relation to the documentation referred to in Chapter I of Annex XIV, the sponsor shall update the relevant data in the electronic system referred to in Article 69 and make that change to the documentation clearly identifiable. The Member State concerned shall be notified of the update by means of that electronic system. 3. Where the Member State concerned finds that the performance study applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 69. The Member State concerned may extend this period by a maximum of 20 days where appropriate. Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers that the application falls under the scope of this Regulation and/or is complete but the Member State concerned does not agree, the application shall be considered to have been rejected. The Member State concerned shall provide for an appeal procedure in respect of such refusal. The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the performance study is considered as falling within the scope of this Regulation and the application is complete. 4. The Member State concerned may also extend the period referred to in paragraphs 1 and 3 each by a further five days. 5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively. 6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received. 7. The sponsor may start the performance study in the following circumstances: (a) in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated by national law, immediately after the validation date of application described in paragraph 5 of this Article, provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study; (b) in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts. 8. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV. 9. In order to assure the uniform application of the requirements laid down in Chapter I of Annex XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 67 Assessment by Member States 1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons financing the performance study, as well as free of any other undue influence. 2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. 3. Member States shall assess whether the performance study is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected. They shall, while taking into account applicable CS or harmonised standards, examine in particular: (a) the demonstration of compliance of the device(s) for performance study with the applicable general safety and performance requirements, apart from the aspects covered by the performance study, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, in case of performance studies, the evaluation of the analytical performance, and in case of interventional clinical performance studies, the evaluation of the analytical performance, clinical performance and scientific validity, taking into consideration the state of the art; (b) whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by harmonised standards; (c) whether the measures planned for the safe installation, putting into service and maintenance of the device for performance study are adequate; (d) the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the performance study and methodological aspects, including sample size, comparator and endpoints; (e) whether the requirements of Annex XIV are met. 4. Member States shall refuse the authorisation of the performance study if: (a) the application dossier submitted pursuant to Article 66(3) remains incomplete; (b) the device or the submitted documents, especially the performance study plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the performance study, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients; (c) the requirements of Article 58 are not met; or (d) any assessment under paragraph 3 is negative. Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph. Article 68 Conduct of a performance study 1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan. 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following: (a) the objective and methodology of the performance study; and (b) the degree of deviation of the intervention from normal clinical practice. 3. All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection. 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network. 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan. 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the study. Article 69 Electronic system on performance studies 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system: (a) to create the single identification numbers for performance studies referred to in Article 66(1); (b) to be used as an entry point for the submission of all applications or notifications for performance studies referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context; (c) for the exchange of information relating to performance studies in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in to Articles 72 and 74; (d) for information to be provided by the sponsor in accordance with Article 73, including the performance study report and its summary as required in paragraph 5 of that Article; (e) for reporting on serious adverse events and device deficiencies, and related updates referred to in Article 76. 2. When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council (26) as concerns performance studies of companion diagnostics. 3. The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission. The information referred to in the other points of that paragraph shall be accessible to the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds: (a) protection of personal data in accordance with Regulation (EC) No 45/2001; (b) protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an overriding public interest in disclosure; (c) effective supervision of the conduct of the performance study by the Member State(s) concerned. 4. No personal data of subjects shall be publicly available. 5. The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union. Article 70 Performance studies regarding devices bearing the CE marking 1. Where a performance study is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1) (\u2018PMPF study\u2019), and where the performance study would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 69. The sponsor shall include the documentation referred to in Section 2 of Part A of Annex XIII and in Annex XIV. Points (b) to (l) and (p) of Article 58(5), and Articles 71, 72 and 73 Article 76(5) and the relevant provisions of Annexes XIII and XIV shall apply to PMPF studies. 2. Where a performance study is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1), Articles 58 to 77 shall apply. Article 71 Substantial modifications to performance studies 1. If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article 69, the Member State(s) in which the performance study is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Annex XIV as part of the notification. Changes to the relevant documentation shall be clearly identifiable. 2. The Member State shall assess any substantial modification to the performance study in accordance with the procedure laid down in Article 67. 3. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in paragraph 1, unless: (a) the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or of public policy; or (b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the performance study, which, in accordance with national law, is valid for that entire Member State. 4. The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts. Article 72 Corrective measures to be taken by Member States and information exchange between Member States on performance studies 1. Where a Member State in which a performance study is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures on its territory: (a) revoke the authorisation for the performance study; (b) suspend or terminate the performance study; (c) require the sponsor to modify any aspect of the performance study. 2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion. That opinion shall be delivered within seven days. 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article, or has refused a performance study, or has been notified by the sponsor of the early termination of a performance study on safety grounds, that Member State shall communicate the corresponding decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 69. 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 69 to all Member States and the Commission. Article 73 Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination 1. If the sponsor has temporarily halted a performance study or has terminated a performance study early, it shall inform within 15 days the Member States in which that performance study has been temporarily halted or terminated early, through the electronic system referred to in Article 69, of the temporary halt or early termination. In the event that the sponsor has temporarily halted or terminated early the performance study on safety grounds, it shall inform all Member States in which that performance study is being conducted thereof within 24 hours. 2. The end of a performance study shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the performance study plan. 3. The sponsor shall notify each Member State in which that performance study was being conducted of the end of that performance study in that Member State. That notification shall be made within 15 days of the end of the performance study in relation to that Member State. 4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member States. That notification shall be made within 15 days of that end of the performance study. 5. Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII. The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 69. Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available. In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study are going to be available, together with a justification. 6. The Commission shall issue guidelines regarding the content and structure of the summary of the performance study report. In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of performance studies. 7. The summary and the performance study report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 69, at the latest when the device is registered in accordance with Article 26 and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission. If the device is not registered in accordance with Article 26 within one year of the summary and the performance study report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time. Article 74 Coordinated assessment procedure for performance studies 1. By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted in more than one Member State may submit, for the purpose of Article 66, a single application that, upon receipt, is transmitted electronically to all Member States in which the performance study is to be conducted. 2. The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States in which the performance study is to be conducted acts as coordinating Member State. The Member States in which the performance study is to be conducted shall, within six days of submission of the application, agree on one of them taking the role of the coordinating Member State. If they do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that role. 3. Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shall coordinate their assessment of the application, in particular of the documentation referred to in Chapter I of Annex XIV. However, the completeness of the documentation referred to in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of Section 2.3.2. of Part A of Annex XIII shall be assessed separately by each Member State concerned in accordance with Article 66(1) to (5). 4. With regard to documentation other than that referred to in the second subparagraph of paragraph 3, the coordinating Member State shall: (a) within six days of receipt of the single application, notify the sponsor that it is the coordinating Member State (\u2018notification date\u2019); (b) for the purpose of the validation of the application, take into account any considerations submitted within seven days of the notification date by any Member State concerned; (c) within 10 days of the notification date, assess whether the performance study falls within the scope of this Regulation and whether the application is complete and shall notify the sponsor accordingly. Article 66(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment; (d) establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the validation date to the Member States concerned. By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned. The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's application in accordance with Article 66(7). 5. As regards the assessment of the documentation referred to in the second subparagraph of paragraph 3, each Member State concerned may request, on a single occasion, additional information from the sponsor. The sponsor shall submit the requested additional information within the period set by the Member State concerned, which shall not exceed 12 days from the receipt of the request. The expiry of the last deadline pursuant to point (d) of paragraph 4 shall be suspended from the date of the request until such time as the additional information has been received. 6. For class C and D devices, the coordinating Member State may also extend the periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts. 7. The Commission may, by means of implementing acts, further specify the procedures and timescales for coordinated assessments to be taken into account by Member States concerned when deciding on the sponsor's application. Such implementing acts may also set out the procedures and timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of this Article and in the case of reporting of adverse events pursuant to Article 76(4) and in the case of performance studies involving companion diagnostics, where the medicinal products are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 8. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the conduct of the performance study is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member State(s) concerned. Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds: (a) when it considers that participation in the performance study would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned; (b) infringement of national law; or (c) considerations as regards subject safety and data reliability and robustness submitted under point (d) of paragraph 4. Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed justification, through the electronic system referred to in Article 69 to the Commission, to all other Member States concerned, and to the sponsor. 9. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the performance study is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned. 10. A Member State concerned shall refuse to authorise a performance study if it disagrees with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV are not complied with, or where an ethics committee has issued a negative opinion in relation to that performance study which is valid in accordance with national law for that entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal. 11. Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 69 as to whether the performance study is authorised, whether it is authorised subject to conditions, or whether authorisation has been refused. Notification shall be done by way of one single decision within five days of the transmission, pursuant to point (d) of paragraph 4 of this Article, by the coordinating Member State of the final assessment report. Where an authorisation of a performance study is subject to conditions, those conditions may only be such that, by their nature, they cannot be fulfilled at the time of that authorisation. 12. Any substantial modifications as referred to in Article 71 shall be notified to the Member States concerned by means of the electronic system referred to in Article 69. Any assessment as to whether there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State, except for substantial modifications concerning sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of Section 2.3.2 of Part A of Annex XIII, which shall be assessed separately by each Member State concerned. 13. The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter. 14. The procedure set out in this Article shall, until 27 May 2029, be applied only by those of the Member States in which the performance studies are to be conducted which have agreed to apply it. After 27 May 2029, all Member States shall be required to apply that procedure. Article 75 Review of the coordinated assessment procedure By 27 May 2028, the Commission shall submit to the European Parliament and to the Council a report on the experience gained from the application of Article 74 and, if necessary, propose a review of Article 74(14) and point (g) of Article 113(3). Article 76 Recording and reporting of adverse events that occur during performance studies 1. The sponsor shall fully record all of the following: (a) any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study; (b) any serious adverse event; (c) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate; (d) any new findings in relation to any event referred to in points (a) to (c). 2. The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in Article 69: (a) any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such causal relationship is reasonably possible; (b) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate; (c) any new findings in relation to any event referred to in points (a) and (b). The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report. Upon request by any Member State in which the performance study is being conducted, the sponsor shall provide all information referred to in paragraph 1. 3. The sponsor shall also report to the Member States in which the performance study is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a performance study is performed under the same clinical performance study plan as the one applying to a performance study covered by this Regulation by means of the electronic system referred to in Article 69. 4. In the case of a performance study for which the sponsor has used the single application referred to in Article 74, the sponsor shall report any event as referred to in paragraph 2 of this Article by means of the electronic system referred to in Article 69. Upon receipt, this report shall be transmitted electronically to all Member States in which the performance study is being conducted. Under the direction of the coordinating Member State referred to in Article 74(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate the performance study or whether to revoke the authorisation for that performance study. This paragraph shall not affect the rights of the other Member States to perform their own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any such measures. 5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply instead of this Article. 6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding performance study has been established. Article 77 Implementing acts The Commission may, by means of implementing acts, establish the detailed arrangements and procedural aspects necessary for the implementation of this Chapter, as regards the following: (a) harmonised electronic forms for the application for performance studies and their assessment as referred to in Articles 66 and 74, taking into account specific categories or groups of devices; (b) the functioning of the electronic system referred to in Article 69; (c) harmonised electronic forms for the notification of PMPF studies as referred to in Article 70(1), and of substantial modifications as referred to in Article 71; (d) the exchange of information between Member States as referred to in Article 72; (e) harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 76; (f) the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in Article 76; (g) uniform application of the requirements regarding the clinical evidence/data needed to demonstrate compliance with the general safety and performance requirements set out in Annex I. The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 107(3). CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE Section 1 Post-market surveillance Article 78 Post-market surveillance system of the manufacturer 1. For each device manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(8). 2. The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions. 3. Data gathered by the manufacturer's post-market surveillance system shall in particular be used: (a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I; (b) to update the design and manufacturing information, the instructions for use and the labelling; (c) to update the performance evaluation; (d) to update the summary of safety and performance referred to in Article 29; (e) for the identification of needs for preventive, corrective or field safety corrective action; (f) for the identification of options to improve the usability, performance and safety of the device; (g) when relevant, to contribute to the post-market surveillance of other devices; and (h) to detect and report trends in accordance with Article 83. The technical documentation shall be updated accordingly. 4. If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 82. Article 79 Post-market surveillance plan The post-market surveillance system referred to in Article 78 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III. The post-market surveillance plan shall be part of the technical documentation specified in Annex II. Article 80 Post-market surveillance report Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the notified body and the competent authority upon request. Article 81 Periodic safety update report 1. Manufacturers of class C and class D devices shall prepare a periodic safety update report (\u2018PSUR\u2019) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out: (a) the conclusions of the benefit-risk determination; (b) the main findings of the PMPF; and (c) the volume of sales of the device and an estimate of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device. Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the technical documentation as specified in Annexes II and III. 2. Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system. 3. For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities. Section 2 Vigilance Article 82 Reporting of serious incidents and field safety corrective actions 1. Manufacturers of devices, made available on the Union market, other than devices for performance study, shall report, to the relevant competent authorities, in accordance with Articles 87(5) and (7), the following: (a) any serious incident involving devices made available on the Union market, except expected erroneous results which are clearly documented and quantified in the product information and in the technical documentation and are subject to trend reporting pursuant to Article 83; (b) any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country. The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 87. 2. As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident. 3. Manufacturers shall report any serious incident as referred to in point (a) immediately after they have established a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident. 4. Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat. 5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident. 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report. 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it shall nevertheless submit a report within the timeframe required in accordance with paragraphs 2 to 5. 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1, in advance of the field safety corrective action being undertaken. 9. For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the coordinating competent authority referred to in Article 84(9), in consultation with the competent authorities referred to in points (a) and (b) of Article 87(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent authority is referred to in points (a) and (b) of Article 87(8), the manufacturer may provide periodic summary reports following agreement with that competent authority. 10. The Member States shall take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities suspected serious incidents referred to in point (a) of paragraph 1. The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients. 11. Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay. Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 84. Where the manufacturer of the device concerned considers that the incident is not a serious incident or is to be treated as an increase in expected erroneous results, which will be covered by trend reporting in accordance with to Article 83, it shall provide an explanatory statement. If the competent authority does not agree with the conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance with Article 84. Article 83 Trend reporting 1. Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically significant increase in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and product information. The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such events or change in performance, as well as the observation period, in the post-market surveillance plan referred to in Article 79. 2. The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures. Article 84 Analysis of serious incidents and field safety corrective actions 1. Following the reporting of a serious incident pursuant to Article 82(1), the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned. This shall include risk assessment of the incident and field safety corrective action taking into account the criteria as referred to in paragraph 3 of this Article as appropriate. The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned during the investigations referred to in the first subparagraph and shall not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action. 2. Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory, or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 82 is evaluated centrally at national level by their competent authority, if possible together with the manufacturer, and, where relevant, the notified body concerned. 3. In the context of the evaluation referred to in paragraph 2, the competent authority shall evaluate the risks arising from the reported serious incident and evaluate any field safety corrective actions, taking into account the protection of public health and criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of direct or indirect harm, the severity of that harm, the clinical benefit of the device, intended and potential users, and the population affected. The competent authority shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other corrective action, in particular taking into account the principle of inherent safety contained in Annex I. Upon request by the national competent authority, manufacturers shall provide for all documents necessary for the risk assessment. 4. The competent authority shall monitor the manufacturer's investigation of a serious incident. Where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent investigation. 5. The manufacturer shall provide a final report to the competent authority setting out its findings from the investigation by means of the electronic system referred to in Article 87. The report shall set out conclusions and where relevant indicate corrective actions to be taken. 6. In the case of companion diagnostic, the evaluating competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall, depending on whether the relevant competent authority of the Member State that authorised the medicinal products or the EMA was consulted by the notified body in accordance with the procedures set out in Section 5.2 of Annex IX and Section 3.11 of Annex X, inform that national competent authority or the EMA, as appropriate. 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating competent authority shall, through the electronic system referred to in Article 87, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident, including information on the underlying serious incidents and the outcome of its assessment. 8. The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice. The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph 9, to the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States. The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action. The field safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons and shall clearly indicate all the actions to be taken by users. The manufacturer shall enter the field safety notice in the electronic system referred to in Article 87 through which that notice shall be accessible to the public. 9. The competent authorities shall actively participate in a procedure in order to coordinate their assessments referred to in paragraph 3 in the following cases: (a) where there is concern regarding a particular serious incident or cluster of serious incidents relating to the same device or type of device of the same manufacturer in more than one Member State; (b) where the appropriateness of a field safety corrective action that is proposed by a manufacturer in more than one Member State is in question. That coordinated procedure shall cover the following: \u2014 designation of a coordinating competent authority on a case by case basis, when required; \u2014 defining the coordinated assessment process, including the tasks and responsibilities of the coordinating competent authority and the involvement of other competent authorities. Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the competent authority of the Member State in which the manufacturer has its registered place of business. The coordinating competent authority shall, through the electronic system referred to in Article 87, inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority. 10. The designation of a coordinating competent authority shall not affect the rights of the other competent authorities to perform their own assessment and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating competent authority and the Commission shall be kept informed of the outcome of any such assessment and the adoption of any such measures. 11. The Commission shall provide administrative support to the coordinating competent authority in the accomplishment of its tasks under this Chapter. Article 85 Analysis of vigilance data The Commission shall, in collaboration with the Member States, put in place systems and processes to actively monitor the data available in the electronic system referred to in Article 87, in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns. Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating competent authority shall inform the manufacturer, or where applicable the authorised representative, which shall then take the necessary corrective actions. Article 86 Implementing acts The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the detailed arrangements and procedural aspects necessary for the implementation of Articles 80 to 85 and 87 as regards the following: (a) the typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices; (b) the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 80, 81, 82, 83 and 84 respectively; (c) standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting of suspected serious incidents by healthcare professionals, users and patients; (d) timelines for the reporting of field safety corrective actions, and for the provision by manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be reported as referred to in Article 82; (e) harmonised forms for the exchange of information between competent authorities as referred to in Article 84; (f) procedures for the designation of a coordinating competent authority; the coordinated evaluation process, including tasks and responsibilities of the coordinating competent authority and involvement of other competent authorities in this process. The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 87 Electronic system on vigilance and post-market surveillance 1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information: (a) reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 82(1) and Article 84(5); (b) the periodic summary reports by manufacturers referred to in Article 82(9); (c) the reports by manufacturers on trends referred to in Article 83; (d) the PSURs referred to in Article 81; (e) the field safety notices by manufacturers referred to in Article 84(8); (f) the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 84(7) and (9). That electronic system shall include relevant links to the UDI database. 2. The information referred to in paragraph 1 of this Article shall be made available through the electronic system to the competent authorities of the Member States and to the Commission. The notified bodies shall also have access to that information to the extent that it relates to devices for which they issued a certificate in accordance with Article 49. 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system referred to in paragraph 1. 4. On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the electronic system referred to in paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union. 5. The reports on serious incidents referred to in point (a) of Article 82(1), shall be automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the Member State in which the incident occurred. 6. The trend reports referred to in Article 83(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the Member States in which the incidents occurred. 7. The reports on field safety corrective actions referred to in point (b) of Article 82(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the following Member States: (a) the Member State in which the field safety corrective action is being or is to be undertaken; (b) the Member State in which the manufacturer has its registered place of business. 8. The periodic summary reports referred to in Article 82(9) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of: (a) the Member State or Member States participating in the coordination procedure in accordance with Article 84(9) and which have agreed on the periodic summary report; (b) the Member State in which the manufacturer has its registered place of business. 9. The information referred to in paragraphs 5 to 8 of this Article shall be automatically transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this Article, to the notified body that issued the certificate for the device in question in accordance with Article 51. Section 3 Market surveillance Article 88 Market surveillance activities 1. The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples. The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints. 2. The competent authorities shall draw up annual surveillance activity plans and allocate a sufficient number of material and competent human resources in order to carry out those activities taking into account the European market surveillance programme developed by the MDCG pursuant to Article 99 and local circumstances. 3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities: (a) may require economic operators to, inter alia, make available the documentation and information necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of devices or access to devices free of charge; and (b) shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users. 4. The competent authorities shall prepare an annual summary of the results of their surveillance activities and make it accessible to other competent authorities by means of the electronic system referred to in Article 95. 5. The competent authorities may confiscate, destroy or otherwise render inoperable devices that present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the protection of public health. 6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority shall draw up a report on the findings of the inspection that concern compliance with the legal and technical requirements applicable under this Regulation. The report shall set out any corrective actions needed. 7. The competent authority which carried out the inspection shall communicate the content of the report referred to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before adopting the final report, the competent authority shall give that economic operator the opportunity to submit comments. That final inspection report shall be entered in the electronic system provided for in Article 95. 8. The Member States shall review and assess the functioning of their market surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. Each Member State shall make a summary of the results accessible to the public by means of the electronic system referred to in Article 95. 9. The competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof, to provide for a harmonised and high level of market surveillance in all Member States. Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint market surveillance activities and specialisation. 10. Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions. 11. Where appropriate, the competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance. Article 89 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance Where the competent authorities of a Member State, based on data obtained by vigilance or market surveillance activities or on other information, have reason to believe that a device: (a) may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or (b) otherwise does not comply with the requirements laid down in this Regulation, they shall carry out an evaluation of the device concerned covering all requirements laid down in this Regulation relating to the risk presented by the device or to any other non-compliance of the device. The relevant economic operators shall cooperate with the competent authorities. Article 90 Procedure for dealing with devices presenting an unacceptable risk to health and safety 1. Where, having performed an evaluation pursuant to Article 89, the competent authorities find that the device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall without delay require the manufacturer of the devices concerned, its authorised representative and all other relevant economic operators to take all appropriate and duly justified corrective action to bring the device into compliance with the requirements of this Regulation relating to the risk presented by the device and, in a manner that is proportionate to the nature of the risk, to restrict the making available of the device on the market, to subject the making available of the device to specific requirements, to withdraw the device from the market, or to recall it, within a reasonable period that is clearly defined and communicated to the relevant economic operator. 2. The competent authorities shall, without delay, notify the Commission, the other Member States and, where a certificate has been issued in accordance with Article 51 for the device concerned, the notified body that issued that certificate, of the results of the evaluation and of the actions which they have required the economic operators to take, by means of the electronic system referred to in Article 95. 3. The economic operators as referred to in paragraph 1 shall, without delay, ensure that all appropriate corrective action is taken throughout the Union in respect of all the devices concerned that they have made available on the market. 4. Where the economic operator as referred to in paragraph 1 does not take adequate corrective action within the period referred to in paragraph 1, the competent authorities shall take all appropriate measures to prohibit or restrict the making available of the device on their national market, to withdraw the device from that market or to recall it. The competent authorities shall notify the Commission, the other Member States and the notified body referred to in paragraph 2 of this Article, without delay, of those measures, by means of the electronic system referred to in Article 95. 5. The notification referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification and tracing of the non-compliant device, the origin of the device, the nature of and the reasons for the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. 6. Member States other than the Member State initiating the procedure shall, without delay, inform the Commission and the other Member States, by means of the electronic system referred to in Article 95, of any additional relevant information at their disposal relating to the non-compliance of the device concerned and of any measures adopted by them in relation to the device concerned. In the event of disagreement with the notified national measure, they shall, without delay, inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 95. 7. Where, within two months of receipt of the notification referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of any measures taken by a Member State, those measures shall be deemed to be justified. In that case, all Member States shall ensure that corresponding appropriate restrictive or prohibitive measures, including withdrawing, recalling or limiting the availability of the device on their national market are taken without delay in respect of the device concerned. Article 91 Procedure for evaluating national measures at Union level 1. Where, within two months of receipt of the notification referred to in Article 90(4), objections are raised by a Member State against a measure taken by another Member State, or where the Commission considers the measure to be contrary to Union law, the Commission shall, after consulting the competent authorities concerned and, where necessary, the economic operators concerned, evaluate that national measure. On the basis of the results of that evaluation, the Commission may decide, by means of implementing acts, whether or not the national measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 2. Where the Commission considers the national measure to be justified as referred to in paragraph 1 of this Article, the second subparagraph of Article 90(7) shall apply. If the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure. Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt of the notification referred to in Article 90(4), the national measure shall be considered to be justified. 3. Where a Member State or the Commission considers that the risk to health and safety emanating from a device cannot be mitigated satisfactorily by means of measures taken by the Member State or Member States concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of implementing acts, the necessary and duly justified measures to ensure the protection of health and safety, including measures restricting or prohibiting the placing on the market and putting into service of the device concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 92 Other non-compliance 1. Where, having performed an evaluation pursuant to Article 89, the competent authorities of a Member State find that a device does not comply with the requirements laid down in this Regulation but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance. 2. Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph 1 of this Article, the Member State concerned shall without delay take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market. That Member State shall inform the Commission and the other Member States without delay of those measures, by means of the electronic system referred to in Article 95. 3. In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 93 Preventive health protection measures 1. Where a Member State, after having performed an evaluation, which indicates a potential risk related to a device or a specific category or group of devices considers that, in order to protect the health and safety of patients, users or other persons or other aspects of public health, the making available on the market or putting into service of a device or a specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled, it may take any necessary and justified measures. 2. The Member State referred to in paragraph 1 shall immediately notify the Commission and all other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 95. 3. The Commission, in consultation with the MDCG and, where necessary, the economic operators concerned, shall assess the national measures taken. The Commission may decide, by means of implementing acts, whether the national measures are justified or not. In the absence of a Commission decision within six months of their notification, the national measures shall be considered to be justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 4. Where the assessment referred to in paragraph 3 of this Article demonstrates that the making available on the market or putting into service of a device, specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in all Member States in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission may adopt implementing acts) to take the necessary and duly justified measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 94 Good administrative practice 1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 90 to 93 shall state the exact grounds on which it is based. Where such a measure is addressed to a specific economic operator, the competent authority shall notify without delay the economic operator concerned of that measure, and shall at the same time inform that economic operator of the remedies available under the law or the administrative practice of the Member State concerned and of the time limits to which such remedies are subject. Where the measure is of general applicability, it shall be appropriately published. 2. Except in cases where immediate action is necessary for reasons of unacceptable risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time that is clearly defined before any measure is adopted. Where action has been taken without the economic operator having had the opportunity to make submissions as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter. 3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator's demonstrating that it has taken effective corrective action and that the device is in compliance with the requirements of this Regulation. 4. Where a measure adopted pursuant to Articles 90 to 93 concerns a device for which a notified body has been involved in the conformity assessment, the competent authorities shall by means of the electronic system referred to in Article 95 inform the relevant notified body and the authority responsible for the notified body of the measure taken. Article 95 Electronic system on market surveillance 1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information: (a) summaries of the results of the surveillance activities referred to in Article 88(4); (b) the final inspection report as referred to in Article 88(7); (c) information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 90(2), (4) and (6); (d) information in relation to non-compliance of products as referred to in Article 92(2); (e) information in relation to the preventive health protection measures referred to in Article 93(2); (f) summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in Article 88(8). 2. The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with Article 51 for the device concerned and be accessible to the Member States and to the Commission. 3. Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States. CHAPTER VIII COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS Article 96 Competent authorities The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States shall communicate the names and contact details of the competent authorities to the Commission which shall publish a list of competent authorities. Article 97 Cooperation 1. The competent authorities of the Member States shall cooperate with each other and with the Commission. The Commission shall provide for the organisation of exchanges of information necessary to enable this Regulation to be applied uniformly. 2. Member States shall with the support of the Commission participate, where appropriate, in initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical devices. Article 98 Medical Device Coordination Group The Medical Device Coordination Group (MDCG) established in accordance with the conditions and detailed arrangements referred to in Article 103 and 107 of Regulation (EU) 2017/745 shall carry out, with the support of the Commission as provided in Article 104 of Regulation (EU) 2017/745, the tasks conferred on it under this Regulation as well as those under Regulation (EU) 2017/745. Article 99 Tasks of the MDCG Under this Regulation, the MDCG shall have the following tasks: (a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV; (b) to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 45; (c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of performance evaluations by manufacturers, assessment by notified bodies and vigilance activities; (d) to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and performance requirements laid down in this Regulation and Regulation (EU) 2017/745 are adequate to ensure safety and performance of devices, and thereby contribute to identifying whether there is a need to amend Annex I to this Regulation; (e) to contribute to the development of device standards and of CS; (f) to assist the competent authorities of the Member States in their coordination activities in particular in the fields of classification and the determination of the regulatory status of devices, performance studies, vigilance and market surveillance including the development and maintenance of a framework for a European market surveillance programme with the objective of achieving efficiency and harmonisation of market surveillance in the Union, in accordance with Article 88; (g) to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue related to the implementation of this Regulation; (h) to contribute to harmonised administrative practice with regard to devices in the Member States. Article 100 The European Union reference laboratories 1. For specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices, the Commission may designate, by means of implementing acts, one or more European Union reference laboratories (the \u2018EU reference laboratories\u2019), that satisfy the criteria set out in paragraph 4. The Commission shall only designate the EU reference laboratories for which a Member State or the Commission's Joint Research Centre have submitted an application for designation. 2. Within the scope of their designation, the EU reference laboratories shall, where appropriate, have the following tasks: (a) to verify the performance claimed by the manufacturer and the compliance of class D devices with the applicable CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3); (b) to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 4.12 of Annex IX and in Section 5.1 of Annex XI; (c) to provide scientific and technical assistance to the Commission, the MDCG, the Member States and notified bodies in relation to the implementation of this Regulation; (d) to provide scientific advice regarding the state of the art in relation to specific devices, or a category or group of devices; (e) to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks; (f) to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance; (g) to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures; (h) to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order; (i) to contribute to the development of CS and of international standards; (j) to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation and publish them by electronic means having considered national provisions on confidentiality. 3. At the request of a Member State, the Commission may also designate the EU reference laboratories where that Member State wishes to have recourse to such laboratories to ensure the verification of the performance claimed by the manufacturer and the compliance of class C devices with the applicable CS when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. 4. The EU reference laboratories shall satisfy the following criteria: (a) have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated; (b) possess the necessary equipment and reference material to carry out the tasks assigned to them; (c) have the necessary knowledge of international standards and best practices; (d) have an appropriate administrative organisation and structure; (e) ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks; (f) act in the public interest and in an independent manner; (g) ensure that their staff do not have financial or other interests in the in vitro diagnostic medical device industry which could affect their impartiality, declare any other direct and indirect interests they may have in the in vitro diagnostic medical device industry and update this declaration whenever a relevant change occurs. 5. The EU reference laboratories shall form a network in order to coordinate and harmonise their working methods as regards testing and assessment. That coordination and harmonisation shall involve: (a) applying coordinated methods, procedures and processes; (b) agreeing on the use of same reference materials and common test samples and seroconversion panels; (c) establishing common assessment and interpretation criteria; (d) using common testing protocols and assessing the test results using standardised and coordinated evaluation methods; (e) using standardised and coordinated test reports; (f) developing, applying and maintaining a peer review system; (g) organizing regular quality assessment tests (including mutual checks on the quality and comparability of test results); (h) agreeing on joint guidelines, instructions, procedural instructions or standard operational procedures; (i) coordinating the introduction of testing methods for new technologies and according to new or amended CS; (j) reassessing the state of the art on the basis of comparative test results or by further studies, as requested by a Member State or by the Commission. 6. The EU reference laboratories may be granted a Union financial contribution. The Commission may adopt, by means of implementing acts, the detailed arrangements and the amount of a Union financial contribution to the EU reference laboratories, taking into account the objectives of health and safety protection, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 7. Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to predetermined and transparent terms and conditions. 8. The Commission shall specify by means of implementing acts: (a) detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure compliance with the criteria referred to in paragraph 4 of this Article. (b) the structure and the level of the fees referred to in paragraph 7 of this Article which may be levied by an EU reference laboratory for providing scientific opinions in response to consultations by notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human health and safety protection, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 9. The EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation. If those controls find that an EU reference laboratory is not complying with the requirements for which it has been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the designation. 10. The provisions in Article 107(1) of Regulation (EU) 2017/745 shall apply to the staff of the EU reference laboratories. Article 101 Device registers and databanks The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices. CHAPTER IX CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES Article 102 Confidentiality 1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: (a) personal data in accordance with Article 103; (b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights unless disclosure is in the public interest; (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits. 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities and between competent authorities and the Commission shall not be disclosed without the prior agreement of the originating authority. 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law. 4. The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. Article 103 Data protection 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation. 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation. Article 104 Levying of fees 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost-recovery principles. 2. Member States shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted. The structure and level of fees shall be made publicly available on request. Article 105 Funding of activities related to designation and monitoring of notified bodies The costs associated with joint assessment activities shall be covered by the Commission. The Commission shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other necessary implementing rules. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 106 Penalties The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those measures by 25 February 2022 and shall notify it without delay of any subsequent amendment affecting them. CHAPTER X FINAL PROVISIONS Article 107 Committee procedure 1. The Commission shall be assisted by the Committee on Medical Devices established by Article 114 of Regulation (EU) 2017/745. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or 5 thereof, as appropriate, shall apply. Article 108 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall be conferred on the Commission for a period of five years from 25 May 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 109 Separate delegated acts for different delegated powers The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation. Article 110 Transitional provisions 1. From 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void. 2. Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI to Directive 98/79/EC which shall become void at the latest on 27 May 2024. Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 shall become void by 27 May 2024. 3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with that Directive, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply and replace the corresponding requirements in that Directive. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all applicable requirements relating to the devices it has certified. 4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025. 5. By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before 26 May 2022. 6. By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2022. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2022. 7. As regards devices subject to the procedures laid down in Article 48(3) and (4), paragraph 5 of this Article applies provided that the necessary appointments to the MDCG and expert panels and of EU reference laboratories have been made. 8. By way of derogation from Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Article 27(3) and Article 28(1) and Article 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC as specified in Decision 2010/227/EU. 9. Authorisations granted by the competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation. 10. Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities. Article 111 Evaluation By 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation report on the progress towards achievement of the objectives contained herein including an assessment of the resources required to implement this Regulation. Special attention shall be given to the traceability of devices through the storage, pursuant to Article 24, of the UDI by economic operators, health institutions and health professionals. The evaluation shall also include a review on the functioning of Article 4. Article 112 Repeal Without prejudice to Articles 110 (3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and the obligations of manufacturers as regards the making available of documentation, under Directive 98/79/EC, that Directive is repealed with effect from 26 May 2022 with the exception of: (a) Article 11, point (c) of Article 12(1) and Article 12(2) and (3) of Directive 98/79/EC, and the obligations relating to vigilance and performance studies provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation; and (b) Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, and the obligations relating to registration of devices and economic operators, and certificate notifications provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation. As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs. Decision 2010/227/EU adopted in implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC shall be repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation. References to the repealed Directive shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XV. Article 113 Entry into force and date of application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 26 May 2022. 3. By way of derogation from paragraph 2: (a) Article 27(3) and Article 51(5) shall apply from 27 November 2023; (b) Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34; (c) Article 97 shall apply from 26 May 2018; (d) Article 100 shall apply from 25 November 2020; (e) for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027; (f) without prejudice to the obligations on the Commission pursuant to Article 34 of Regulation (EU) 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) of that Regulation. The provisions referred to in the preceding sentence are: \u2014 Article 26, \u2014 Article 28, \u2014 Article 29, \u2014 the second sentence of Article 36(2), \u2014 Article 38(10), \u2014 Article 39(2), \u2014 the second subparagraph of Article 40(12), \u2014 points (d) and (e) of Article 42(7), \u2014 Article 49(2), \u2014 Article 50(1), \u2014 Articles 66 to 73, \u2014 paragraphs 1 to 13 of Article 74, \u2014 Articles 75 to 77, \u2014 Article 81(2), \u2014 Articles 82 and 83, \u2014 Article 84(5) and (7) and the third subparagraph of Article 84(8), \u2014 Article 85, \u2014 Article 88(4), (7) and (8), \u2014 Article 90(2) and (4), \u2014 the last sentence of Article 92(2), \u2014 Article 94(4), \u2014 the second sentence of the first subparagraph of Article 110(3). Until Eudamed is fully functional the corresponding provisions of Directive 98/79/EC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding performance studies, vigilance reporting, registration of devices and economic operators, and certificate notifications. (g) The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14). (h) Article 110(10) shall apply from 26 May 2019. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 5 April 2017. For the European Parliament The President A. TAJANI For the Council The President I. BORG (1) Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p. 52). (2) Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of the Council at first reading of 7 March 2017 (not yet published in the Official Journal). (3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1). (4) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). (5) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1). (6) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (7) Regulation (EU) No 1025/2012 of 25 October 2012 of the European Parliament and of the Council on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (8) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (9) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). (10) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29). (11) Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C-400/09 and C-207/10, ECLI:EU:C:2011:519. (12) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (see page 1 of this Official Journal). (13) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45). (14) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (15) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (16) Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010. p. 33). (17) OJ L 123, 12.5.2016, p. 1. (18) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (19) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17) (20) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) (21) OJ C 358, 7.12.2013, p. 10. (22) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (OJ L 157, 9.6.2006, p. 24). (23) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). (24) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (25) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). (26) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). ANNEXES I General safety and performance requirements II Technical documentation III Technical documentation on post-market surveillance IV EU declaration of conformity V CE marking of conformity VI Information to be submitted upon the registration of devices and economic operators in accordance with Articles 26(3) and 28, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 25 and 26 and the UDI system VII Requirements to be met by notified bodies VIII Classification rules IX Conformity assessment based on a quality management system and on assessment of technical documentation X Conformity assessment based on type examination XI Conformity assessment based on production quality assurance XII Certificates issued by a notified body XIII Performance evaluation, performance studies and post-market performance follow-up XIV Interventional clinical performance studies and certain other performance studies XV Correlation table ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS CHAPTER I GENERAL REQUIREMENTS 1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. 2. The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio. 3. Manufacturers shall establish, implement, document and maintain a risk management system. Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall: (a) establish and document a risk management plan for each device; (b) identify and analyse the known and foreseeable hazards associated with each device; (c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse; (d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4; (e) evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, the benefit-risk ratio and risk acceptability; and (f) based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4. 4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, the manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority: (a) eliminate or reduce risks as far as possible through safe design and manufacture; (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users. Manufacturers shall inform users of any residual risks. 5. In eliminating or reducing risks related to use error, the manufacturer shall: (a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and (b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users). 6. The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions. 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer. 8. All known and foreseeable risks, and any undesirable effects shall be minimised and be acceptable when weighed against the evaluated potential benefits to the patients and/or the user arising from the intended performance of the device during normal conditions of use. CHAPTER II REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE 9. Performance characteristics 9.1. Devices shall be designed and manufactured in such a way that they are suitable for the purposes referred to in point (2) of Article 2, as specified by the manufacturer, and suitable with regard to the performance they are intended to achieve, taking account of the generally acknowledged state of the art. They shall achieve the performances, as stated by the manufacturer and in particular, where applicable: (a) the analytical performance, such as, analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, cross-reactions; and (b) the clinical performance, such as diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations. 9.2. The performance characteristics of the device shall be maintained during the lifetime of the device as indicated by the manufacturer. 9.3. Where the performance of devices depends on the use of calibrators and/or control materials, the metrological traceability of values assigned to calibrators and/or control materials shall be assured through suitable reference measurement procedures and/or suitable reference materials of a higher metrological order. Where available, metrological traceability of values assigned to calibrators and control materials shall be assured to certified reference materials or reference measurement procedures. 9.4. The characteristics and performances of the device shall be specifically checked in the event that they may be affected when the device is used for the intended use under normal conditions: (a) for devices for self-testing, performances obtained by laypersons; (b) for devices for near-patient testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances). 10. Chemical, physical and biological properties 10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled. Particular attention shall be paid to the possibility of impairment of analytical performance due to physical and/or chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device. 10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure. 10.3. Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably practicable the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction (\u2018CMR\u2019), in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2). 10.4. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress of substances into the device, taking into account the device and the nature of the environment in which it is intended to be used. 11. Infection and microbial contamination 11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or, where applicable, other persons. The design shall: (a) allow easy and safe handling; (b) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use; and, where necessary (c) prevent microbial contamination of the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. 11.2. Devices labelled either as sterile or as having a specific microbial state shall be designed, manufactured and packaged to ensure that their sterile condition or microbial state is maintained under the transport and storage conditions specified by the manufacturer until that packaging is opened at the point of use, unless the packaging which maintains their sterile condition or microbial state is damaged. 11.3. Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods. 11.4. Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities. 11.5. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer. 11.6. The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile. 12. Devices incorporating materials of biological origin Where devices include tissues, cells and substances of animal, human or microbial origin, the selection of sources, the processing, preservation, testing and handling of tissues, cells and substances of such origin and control procedures shall be carried out so as to provide safety for user or other person. In particular, safety with regard to microbial and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This might not apply to certain devices if the activity of the microbial and other transmissible agent are integral to the intended purpose of the device or when such elimination or inactivation process would compromise the performance of the device. 13. Construction of devices and interaction with their environment 13.1. If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system, shall be safe and shall not impair the specified performances of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. 13.2. Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible: (a) the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features; (b) risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences; (c) the risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use; (d) the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts; (e) the risks of accidental ingress of substances into the device; (f) the risk of incorrect identification of specimens and the risk of erroneous results due to, for example, confusing colour and/or numeric and/or character codings on specimen receptacles, removable parts and/or accessories used with devices in order to perform the test or assay as intended; (g) the risks of any foreseeable interference with other devices. 13.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention shall be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion. 13.4. Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively. 13.5. Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe. 13.6. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by users, or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use. 13.7 The measuring, monitoring or display scale (including colour change and other visual indicators) shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used. 14. Devices with a measuring function 14.1. Devices having a primary analytical measuring function shall be designed and manufactured in such a way as to provide appropriate analytical performance in accordance with point (a) of Section 9.1 of Annex I, taking into account the intended purpose of the device. 14.2. The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC (3). 15. Protection against radiation 15.1. Devices shall be designed, manufactured and packaged in such a way that exposure of users or other persons to radiation (intended, unintended, stray or scattered) is reduced as far as possible and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for diagnostic purposes. 15.2. When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall as far as possible be: (a) designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation emitted can be controlled and/or adjusted; and (b) fitted with visual displays and/or audible warnings of such emissions. 15.3. The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified. 16. Electronic programmable systems \u2014 devices that incorporate electronic programmable systems and software that are devices in themselves 16.1. Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks or impairment of performance. 16.2. For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation. 16.3. Software referred to in this Section that is intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise). 16.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended. 17. Devices connected to or equipped with an energy source 17.1. For devices connected to or equipped with an energy source, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks. 17.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming critical. 17.3. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment. 17.4. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electromagnetic interference such that is adequate to enable them to operate as intended. 17.5. Devices shall be designed and manufactured in such a way as to avoid as far as possible the risk of accidental electric shocks to the user, or other person both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer. 18. Protection against mechanical and thermal risks 18.1. Devices shall be designed and manufactured in such a way as to protect users and other persons against mechanical risks. 18.2. Devices shall be sufficiently stable under the foreseen operating conditions. They shall be suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer. 18.3. Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means shall be incorporated. Any guards or other means included with the device to provide protection, in particular against moving parts, shall be secure and shall not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer. 18.4. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance. 18.5. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance. 18.6. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible risks. 18.7. Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings. The same information shall be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk. 18.8. Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use. 19. Protection against the risks posed by devices intended for self-testing or near-patient testing 19.1. Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user's technique and environment. The information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result provided by the device and to avoid misleading information. In the case of near-patient testing, the information and the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience required by the user. 19.2. Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way as to: (a) ensure that the device can be used safely and accurately by the intended user at all stages of the procedure if necessary after appropriate training and/or information; and (b) reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, the specimen, and also in the interpretation of the results. 19.3. Devices intended for self-testing and near-patient testing shall, where feasible, include a procedure by which the intended user: (a) can verify that, at the time of use, the device will perform as intended by the manufacturer; and (b) be warned if the device has failed to provide a valid result. CHAPTER III REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE 20. Label and instructions for use 20.1. General requirements regarding the information supplied by the manufacturer Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following: (a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. (b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit. If individual full labelling of each unit is not practicable, the information shall be set out on the packaging of multiple devices. (c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification or bar codes. (d) Instructions for use shall be provided together with devices. However, in duly justified and exceptional cases instructions for use shall not be required or may be abbreviated if the device can be used safely and as intended by the manufacturer without any such instructions for use. (e) Where multiple devices, with the exception of devices intended for self-testing or near-patient testing, are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge. (f) When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing. (g) Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer. (h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols, taking into account the intended users. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device. (i) In the case of devices containing a substance or a mixture which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given in the instructions for use. (j) The provisions of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all relevant information, as appropriate, is already made available in the instructions for use. 20.2. Information on the label The label shall bear all of the following particulars: (a) the name or trade name of the device; (b) the details strictly necessary for a user to identify the device and, where it is not obvious for the user, the intended purpose of the device; (c) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business; (d) if the manufacturer has its registered place of business outside the Union, the name of its authorised representative and the address of the registered place of business of the authorised representative; (e) an indication that the device is an in vitro diagnostic medical device, or if the device is a \u2018device for performance study\u2019, an indication of that fact; (f) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate; (g) the UDI carrier as referred to in Article 24 and Part C of Annex VI; (h) an unambiguous indication of the time limit for using the device safely, without degradation of performance, expressed at least in terms of year and month and, where relevant, the day, in that order; (i) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable; (j) where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of thereof, or other terms which accurately reflect the contents of the package; (k) an indication of any special storage and/or handling condition that applies; (l) where appropriate, an indication of the sterile state of the device and the sterilisation method, or a statement indicating any special microbial state or state of cleanliness; (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device or to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; (n) if the instructions for use are not provided in paper form in accordance with point (f) of Section 20.1, a reference to their accessibility (or availability), and where applicable the website address where they can be consulted; (o) where applicable, any particular operating instructions; (p) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union; (q) if the device is intended for self-testing or near-patient testing, an indication of that fact; (r) where rapid assays are not intended for self-testing or near-patient testing, the explicit exclusion hereof; (s) where device kits include individual reagents and articles that are made available as separate devices, each of those devices shall comply with the labelling requirements contained in this Section and with the requirements of this Regulation; (t) the devices and separate components shall be identified, where applicable in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. As far as practicable and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales packaging; (u) the label for devices for self-testing shall bear the following particulars: (i) the type of specimen(s) required to perform the test (e.g. blood, urine or saliva); (ii) the need for additional materials for the test to function properly; (iii) contact details for further advice and assistance. The name of devices for self-testing shall not reflect an intended purpose other than that specified by the manufacturer. 20.3. Information on the packaging which maintains the sterile condition of a device (\u2018sterile packaging\u2019): The following particulars shall appear on the sterile packaging: (a) an indication permitting the sterile packaging to be recognised as such, (b) a declaration that the device is in a sterile condition, (c) the method of sterilisation, (d) the name and address of the manufacturer, (e) a description of the device, (f) the month and year of manufacture, (g) an unambiguous indication of the time limit for using the device safely, expressed at least in terms of year and month and, where relevant, the day, in that order, (h) an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use. 20.4. Information in the instructions for use 20.4.1. The instructions for use shall contain all of the following particulars: (a) the name or trade name of the device; (b) the details strictly necessary for the user to uniquely identify the device; (c) the device's intended purpose: (i) what is detected and/or measured; (ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic); (iii) the specific information that is intended to be provided in the context of: \u2014 a physiological or pathological state; \u2014 congenital physical or mental impairments; \u2014 the predisposition to a medical condition or a disease; \u2014 the determination of the safety and compatibility with potential recipients; \u2014 the prediction of treatment response or reactions; \u2014 the definition or monitoring of therapeutic measures; (iv) whether it is automated or not; (v) whether it is qualitative, semi-quantitative or quantitative; (vi) the type of specimen(s) required; (vii) where applicable, the testing population; and (viii) for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test. (d) an indication that the device is an in vitro diagnostic medical device, or, if the device is a \u2018device for performance study\u2019, an indication of that fact; (e) the intended user, as appropriate (e.g. self-testing, near patient and laboratory professional use, healthcare professionals); (f) the test principle; (g) a description of the calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated instrument only); (h) a description of the reagents and any limitation upon their use (e.g. suitable for a dedicated instrument only) and the composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device contains other ingredients which might influence the measurement; (i) a list of materials provided and a list of special materials required but not provided; (j) for devices intended for use in combination with or installed with or connected to other devices and/or general purpose equipment: \u2014 information to identify such devices or equipment, in order to obtain a validated and safe combination, including key performance characteristics, and/or \u2014 information on any known restrictions to combinations of devices and equipment. (k) an indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling conditions which apply; (l) in-use stability which may include the storage conditions, and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions, where this is relevant; (m) if the device is supplied as sterile, an indication of its sterile state, the sterilisation method and instructions in the event of the sterile packaging being damaged before use; (n) information that allows the user to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device. That information shall cover, where appropriate: (i) warnings, precautions and/or measures to be taken in the event of malfunction of the device or its degradation as suggested by changes in its appearance that may affect performance, (ii) warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature, (iii) warnings, precautions and/or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment, (iv) precautions related to materials incorporated into the device that contain or consist of CMR substances, or endocrine disrupting substances or that could result in sensitisation or an allergic reaction by the patient or user, (v) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union, (vi) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, decontamination, packaging and, where appropriate, the validated method of re-sterilisation. Information shall be provided to identify when the device should no longer be reused, such as signs of material degradation or the maximum number of allowable reuses; (o) any warnings and/or precautions related to potentially infectious material that is included in the device; (p) where relevant, requirements for special facilities, such as a clean room environment, or special training, such as on radiation safety, or particular qualifications of the intended user; (q) conditions for collection, handling, and preparation of the specimen; (r) details of any preparatory treatment or handling of the device before it is ready for use, such as sterilisation, final assembly, calibration, etc., for the device to be used as intended by the manufacturer; (s) the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant: \u2014 details of the nature, and frequency, of preventive and regular maintenance, including cleaning and disinfection; \u2014 identification of any consumable components and how to replace them; \u2014 information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime; \u2014 methods for mitigating the risks encountered by persons involved in installing, calibrating or servicing devices. (t) where applicable, recommendations for quality control procedures; (u) the metrological traceability of values assigned to calibrators and control materials, including identification of applied reference materials and/or reference measurement procedures of higher order and information regarding maximum (self-allowed) batch to batch variation provided with relevant figures and units of measure; (v) assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding batch to batch variation provided with relevant figures and units of measure; (w) analytical performance characteristics, such as analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and measurement range, (information needed for the control of known relevant interferences, cross-reactions and limitations of the method), measuring range, linearity and information about the use of available reference measurement procedures and materials by the user; (x) clinical performance characteristics as defined in Section 9.1 of this Annex; (y) the mathematical approach upon which the calculation of the analytical result is made; (z) where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity and diagnostic specificity, positive and negative predictive value; (aa) where relevant, reference intervals in normal and affected populations; (ab) information on interfering substances or limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age of specimen) that may affect the performance of the device; (ac) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and the consumables used with it, if any. This information shall cover, where appropriate: (i) infection or microbial hazards, such as consumables contaminated with potentially infectious substances of human origin; (ii) environmental hazards such as batteries or materials that emit potentially hazardous levels of radiation); (iii) physical hazards such as explosion. (ad) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business at which he can be contacted and its location be established, together with a telephone number and/or fax number and/or website address to obtain technical assistance; (ae) date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use, with a clear indication of the introduced modifications; (af) a notice to the user that any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority of the Member State in which the user and/or the patient is established; (ag) where device kits include individual reagents and articles that may be made available as separate devices, each of these devices shall comply with the instructions for use requirements contained in this Section and with the requirements of this Regulation; (ah) for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended. 20.4.2 In addition, the instructions for use for devices intended for self-testing shall comply with all of the following principles: (a) details of the test procedure shall be given, including any reagent preparation, specimen collection and/or preparation and information on how to run the test and interpret the results; (b) specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to use the device and to understand the result(s) produced by the device; (c) the device's intended purpose shall provide sufficient information to enable the user to understand the medical context and to allow the intended user to make a correct interpretation of the results; (d) the results shall be expressed and presented in a way that is readily understood by the intended user; (e) information shall be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result), on the test limitations and on the possibility of false positive or false negative result. Information shall also be provided as to any factors that can affect the test result such as age, gender, menstruation, infection, exercise, fasting, diet or medication; (f) the information provided shall include a statement clearly directing that the user should not take any decision of medical relevance without first consulting the appropriate healthcare professional, information on disease effects and prevalence, and, where available, information specific to the Member State(s) where the device is placed on the market on where a user can obtain further advice such as national helplines, websites; (g) for devices intended for self-testing used for the monitoring of a previously diagnosed existing disease or condition, the information shall specify that the patient should only adapt the treatment if he has received the appropriate training to do so. (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 136, 29.5.2007, p. 3). (3) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40). ANNEX II TECHNICAL DOCUMENTATION The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex. 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES 1.1. Device description and specification (a) product or trade name and a general description of the device including its intended purpose and intended users; (b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability; (c) the intended purpose of the device which may include information on: (i) what is to be detected and/or measured; (ii) its function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic; (iii) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate; (iv) whether it is automated or not; (v) whether it is qualitative, semi-quantitative or quantitative; (vi) the type of specimen(s) required; (vii) where applicable, the testing population; (viii) the intended user; (ix) in addition, for companion diagnostics, the relevant target population and the associated medicinal product(s). (d) the description of the principle of the assay method or the principles of operation of the instrument; (e) the rationale for the qualification of the product as a device; (f) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII; (g) the description of the components and where appropriate, the description of the reactive ingredients of relevant components such as antibodies, antigens, nucleic acid primers; and where applicable: (h) the description of the specimen collection and transport materials provided with the device or descriptions of specifications recommended for use; (i) for instruments of automated assays: the description of the appropriate assay characteristics or dedicated assays; (j) for automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation; (k) a description of any software to be used with the device; (l) a description or complete list of the various configurations/variants of the device that are intended to be made available on the market; (m) a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with the device. 1.2. Reference to previous and similar generations of the device (a) an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist; (b) an overview of identified similar devices available on the Union or international markets, where such devices exist. 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER A complete set of (a) the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in the case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; (b) the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold. 3. DESIGN AND MANUFACTURING INFORMATION 3.1. Design information Information to allow the design stages applied to the device to be understood shall include: (a) a description of the critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use with the device; (b) for instruments, a description of major subsystems, analytical technology such as operating principles and control mechanisms, dedicated computer hardware and software; (c) for instruments and software, an overview of the entire system; (d) for software, a description of the data interpretation methodology, namely the algorithm; (e) for devices intended for self-testing or near-patient testing, a description of the design aspects that make them suitable for self-testing or near-patient testing. 3.2. Manufacturing information (a) information to allow the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device to be understood. More detailed information shall be provided for the audit of the quality management system or other applicable conformity assessment procedures; (b) identification of all sites, including suppliers and sub-contractors, where manufacturing activities are performed. 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall also include: (a) the general safety and performance requirements that apply to the device and an explanation as to why others do not apply; (b) the method or methods used to demonstrate conformity with each applicable general safety and performance requirement; (c) the harmonised standards, CS or other solutions applied; (d) the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation. 5. BENFIT-RISK ANALYSIS AND RISK MANAGEMENT The documentation shall contain information on: (a) the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and (b) the solutions adopted and the results of the risk management referred to in Section 3 of Annex I. 6. PRODUCT VERIFICATION AND VALIDATION The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements. This includes: 6.1. Information on analytical performance of the device 6.1.1. Specimen type This Section shall describe the different specimen types that can be analysed, including their stability such as storage, where applicable specimen transport conditions and, with a view to time-critical analysis methods, information on the timeframe between taking the specimen and its analysis and storage conditions such as duration, temperature limits and freeze/thaw cycles. 6.1.2. Analytical performance characteristics 6.1.2.1. Accuracy of measurement (a) Trueness of measurement This Section shall provide information on the trueness of the measurement procedure and summarise the data in sufficient detail to allow an assessment of the adequacy of the means selected to establish the trueness. Trueness measures apply to both quantitative and qualitative assays only when a certified reference material or certified reference method is available. (b) Precision of measurement This Section shall describe repeatability and reproducibility studies. 6.1.2.2. Analytical sensitivity This Section shall include information about the study design and results. It shall provide a description of specimen type and preparation including matrix, analyte levels, and how levels were established. The number of replicates tested at each concentration shall also be provided as well as a description of the calculation used to determine assay sensitivity. 6.1.2.3. Analytical specificity This Section shall describe interference and cross reactivity studies performed to determine the analytical specificity in the presence of other substances/agents in the specimen. Information shall be provided on the evaluation of potentially interfering and cross-reacting substances or agents on the assay, on the tested substance or agent type and its concentration, specimen type, analyte test concentration, and results. Interferents and cross-reacting substances or agents, which vary greatly depending on the assay type and design, could derive from exogenous or endogenous sources such as: (a) substances used for patient treatment such as medicinal products; (b) substances ingested by the patient such as alcohol, foods; (c) substances added during specimen preparation such as preservatives, stabilisers; (d) substances encountered in specific specimen types such as haemoglobin, lipids, bilirubin, proteins; (e) analytes of similar structure such as precursors, metabolites or medical conditions unrelated to the test condition including specimens negative for the assay but positive for a condition that can mimic the test condition. 6.1.2.4. Metrological traceability of calibrator and control material values 6.1.2.5. Measuring range of the assay This Section shall include information on the measuring range regardless of whether the measuring systems are linear or non-linear, including the limit of detection and describe information on how the range and detection limit were established. This information shall include a description of specimen type, number of specimens, number of replicates, and specimen preparation including information on the matrix, analyte levels and how levels were established. If applicable, a description of any high dose hook effect and the data supporting the mitigation such as dilution steps shall be added. 6.1.2.6. Definition of assay cut-off This Section shall provide a summary of analytical data with a description of the study design including methods for determining the assay cut-off, such as: (a) the population(s) studied: demographics, selection, inclusion and exclusion criteria, number of individuals included; (b) method or mode of characterisation of specimens; and (c) statistical methods such as Receiver Operator Characteristic (ROC) to generate results and if applicable, define grey-zone/equivocal zone. 6.1.3. The analytical performance report referred to in Annex XIII. 6.2. Information on clinical performance and clinical evidence. Performance Evaluation Report The documentation shall contain the performance evaluation report, which includes the reports on the scientific validity, the analytical and the clinical performance, as referred to in Annex XIII, together with an assessment of those reports. The clinical performance study documents referred to in Section 2 of Part A of Annex XIII shall be included and/or fully referenced in the technical documentation. 6.3. Stability (excluding specimen stability) This Section shall describe claimed shelf life, in use stability and shipping stability studies. 6.3.1. Claimed shelf-life This Section shall provide information on stability testing studies to support the shelf life that is claimed for the device. Testing shall be performed on at least three different lots manufactured under conditions that are essentially equivalent to routine production conditions. The three lots do not need to be consecutive. Accelerated studies or extrapolated data from real time data are acceptable for initial shelf life claims but shall be followed up with real time stability studies. Such detailed information shall include: (a) the study report including the protocol, number of lots, acceptance criteria and testing intervals; (b) where accelerated studies have been performed in anticipation of the real time studies, the method used for accelerated studies shall be described; (c) the conclusions and claimed shelf life. 6.3.2. In-use stability This Section shall provide information on in-use stability studies for one lot reflecting actual routine use of the device, regardless of whether real or simulated. This may include open vial stability and/or, for automated instruments, on board stability. In the case of automated instrumentation, if calibration stability is claimed, supporting data shall be included. Such detailed information shall include: (a) the study report (including the protocol, acceptance criteria and testing intervals); (b) the conclusions and claimed in-use stability. 6.3.3. Shipping stability This Section shall provide information on shipping stability studies for one lot of devices to evaluate the tolerance of devices to the anticipated shipping conditions. Shipping studies may be done under real and/or simulated conditions and shall include variable shipping conditions such as extreme heat and/or cold. Such information shall describe: (a) the study report (including the protocol, acceptance criteria); (b) the method used for simulated conditions; (c) the conclusion and recommended shipping conditions. 6.4. Software verification and validation The documentation shall contain evidence of the validation of the software, as it is used in the finished device. Such information shall typically include the summary results of all verification, validation and testing performed in-house and applicable in an actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the labelling. 6.5. Additional information required in specific cases (a) In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with regard to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues. (b) In the case of devices containing tissues, cells and substances of animal, human or microbial origin, information on the origin of such material and on the conditions in which it was collected. (c) In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications. (d) If the device is to be connected to other equipment in order to operate as intended, a description of the resulting combination including proof that it conforms to the general safety and performance requirements set out in Annex I when connected to any such equipment having regard to the characteristics specified by the manufacturer. ANNEX III TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 78 to 81 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex. 1. The post-market surveillance plan drawn up in accordance with Article 79. The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 78. (a) The post-market surveillance plan shall address the collection and utilisation of available information, in particular: \u2014 information concerning serious incidents, including information from PSURs, and field safety corrective actions, \u2014 records referring to non-serious incidents and data on any undesirable side-effects, \u2014 information from trend reporting, \u2014 relevant specialist or technical literature, databases and/or registers, \u2014 information, including feedbacks and complaints, provided by users, distributors and importers, and \u2014 publicly-available information about similar medical devices. (b) The post-market surveillance plan shall cover at least: \u2014 a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market; \u2014 effective and appropriate methods and processes to assess the collected data; \u2014 suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I; \u2014 effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field; \u2014 methods and protocols to manage the events subject to the trend report as provided for in Article 83, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period; \u2014 methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users; \u2014 reference to procedures to fulfil the manufacturers obligations laid down in Articles 78, 79 and 81; \u2014 systematic procedures to identify and initiate appropriate measures including corrective actions; \u2014 effective tools to trace and identify devices for which corrective actions might be necessary; and \u2014 a PMPF plan as referred to in Part B of Annex XIII, or a justification as to why a PMPF is not applicable. 2. The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80. ANNEX IV EU DECLARATION OF CONFORMITY The EU declaration of conformity shall contain the following information: 1. Name, registered trade name or registered trade mark and, if already issued, SRN referred to in Article 28 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established; 2. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer; 3. The Basic UDI-DI as referred to in Part C of Annex VI; 4. Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3; 5. Risk class of the device in accordance with the rules set out in Annex VIII; 6. A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity; 7. References to any CS used and in relation to which conformity is declared; 8. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued; 9. Where applicable, additional information; 10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature. ANNEX V CE MARKING OF CONFORMITY 1. The CE marking shall consist of the initials \u2018CE\u2019 taking the following form: 2. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing shall be respected. 3. The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices. ANNEX VI INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM PART A INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28 Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party. 1. Information relating to the economic operator 1.1. type of economic operator (manufacturer, authorised representative, or importer), 1.2. name, address and contact details of the economic operator, 1.3. where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person, 1.4. name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15, 2. Information relating to the device 2.1. Basic UDI-DI, 2.2. type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates, 2.3. Member State in which the device shall or has been placed on the market in the Union, 2.4. in the case of class B, class C or class D devices: Member States where the device is or is to be made available, 2.5. presence of tissues, cells, or, their derivatives, of human origin (y/n), 2.6. presence of tissues, cells or their derivatives of animal origin as referred to in Regulation (EU) No 722/2012(y/n), 2.7. presence of cells or substances of microbial origin (y/n), 2.8. risk class of the device, 2.9. where applicable, the single identification number of the performance study, 2.10. in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(14), the name, address and contact details of that legal or natural person, 2.11. in the case of class C or D devices, the summary of safety and performance, 2.12. status of the device (on the market, no longer placed on the market, recalled, field safety corrective Action initiated), 2.13. indication as to whether the device is a \u2018new\u2019 device. A device shall be considered to be \u2018new\u2019 if: (a) there has been no such device continuously available on the Union market during the previous three years for the relevant analyte or other parameter; (b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three years. 2.14. indication as to whether the device is intended for self-testing or near-patient testing. PART B CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 The manufacturer shall provide to the UDI database the UDI-DI and the following information relating to the manufacturer and the device: 1. quantity per package configuration, 2. the Basic UDI-DI as referred to in Article 24(6) and any additional UDI-DIs, 3. the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number), 4. if applicable, the \u2018unit of use\u2019 UDI-DI (where a UDI is not labelled on the device at the level of its \u2018unit of use\u2019, a \u2018unit of use\u2019 UDI-DI shall be assigned so as to associate the use of a device with a patient), 5. name and address of the manufacturer, as indicated on the label, 6. the SRN issued in accordance with Article 28(2), 7. if applicable, name and address of the authorised representative (as indicated on the label), 8. the medical device nomenclature code as provided for in Article 23, 9. risk class of the device, 10. if applicable, name or trade name, 11. if applicable, device model, reference, or catalogue number, 12. additional product description (optional), 13. if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use), 14. if applicable, additional trade names of the device, 15. labelled as a single use device (y/n), 16. if applicable, the maximum number of reuses, 17. device labelled sterile (y/n), 18. need for sterilisation before use (y/n), 19. URL for additional information, such as electronic instructions for use (optional), 20. if applicable, critical warnings or contra-indications, 21. status of the device (on the market, no longer placed on the market, recalled, field safety action initiated). PART C THE UDI SYSTEM 1. Definitions Automatic identification and data capture (\u2018AIDC\u2019) AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID. Basic UDI-DI The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity. Unit of Use DI The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together. Configurable device A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves. Configuration Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customised to meet specific needs. UDI-DI The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the \u2018access key\u2019 to information stored in a UDI database. Human Readable Interpretation (HRI) HRI is a legible interpretation of the data characters encoded in the UDI carrier. Packaging levels Packaging levels means the various levels of device packaging that contain a fixed quantity of devices, such as a carton or case. Production Identifier (UDI-PI) The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PI(s) include serial number, lot number, software identification and manufacturing or expiry date or both types of date. Radio Frequency Identification (\u2018RFID\u2019) RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification. Shipping containers A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems. Unique Device Identifier (\u2018UDI\u2019) The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI. The word \u2018Unique\u2019 does not imply serialisation of individual production units. UDI carrier The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI. UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID. 2. General requirements 2.1. The affixing of the UDI is an additional requirement \u2014 it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation. 2.2. The manufacturer shall assign and maintain unique UDIs for its devices. 2.3. Only the manufacturer may place the UDI on the device or its packaging. 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 24(2) may be used. 3. The UDI 3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI. 3.2. Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements. 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI. 3.4. The UDI-DI shall be unique at each level of device packaging. 3.5. If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI. 3.6. Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI. 3.7. Kits shall be assigned and bear their own UDI. 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard. 3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, any change of one of the following UDI database data elements shall require a new UDI-DI: (a) Name or trade name, (b) device version or model, (c) labelled as single use, (d) packaged sterile, (e) need for sterilization before use, (f) quantity of devices provided in a package, (g) critical warnings or contra-indications. 3.10. Manufacturers that repackage or relabel devices with their own label shall retain a record of the original device manufacturer's UDI. 4. UDI carrier 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label and on all higher levels of device packaging. Higher levels do not include shipping containers. 4.2. In the event of there being significant space constraints on the unit of use packaging the UDI carrier may be placed on the next higher packaging level. 4.3. For single use class A and class B devices packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging e.g. a carton containing several packages. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging. 4.4. For devices exclusively intended for retail point of sale, the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging. 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable. 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable. 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC. 4.8. The HRI format shall follow the rules of the UDI code-issuing entity. 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label. 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device. 4.12. If the UDI carrier is readily readable or scannable through the device's packaging, the placing of the UDI carrier on the packaging shall not be required. 4.13. In the case of single finished devices made up of multiple parts that must be assembled before first use, it shall be sufficient to place the UDI carrier on only one part of each device. 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage. 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data. 5. General principles of the UDI database 5.1. The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex. 5.2. Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database. 5.3. Appropriate methods/procedures for validation of the data provided shall be implemented. 5.4. Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market. 5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation. 5.6. The database shall allow for the linking of all the packaging levels of the device. 5.7. The data for new UDI-DIs shall be available at the time the device is placed on the market. 5.8. Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI. 5.9. Internationally accepted standards for data submission and updates shall, wherever possible, be used by the UDI database. 5.10. The user interface of the UDI database shall be available in all official languages of the Union. The use of free-text fields shall, however, be minimised in order to reduce translations. 5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database. 6. Rules for specific device types 6.1. Reusable devices that are part of kits and that require cleaning, disinfection, sterilisation or refurbishing between uses 6.1.1. The UDI of such devices shall be placed on the device and shall be readable after each procedure to make the device ready for the next use; 6.1.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer. 6.2. Device software 6.2.1. UDI assignment Criteria The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement. The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI. 6.2.2. A new UDI-DI shall be required whenever there is a modification that changes: (a) the original performance, (b) the safety or the intended use of the software. (c) interpretation of data. Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability. 6.2.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI: Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency. Minor software revisions shall be identified by a manufacturer-specific form of identification. 6.2.4. UDI placement criteria for software (a) where the software is delivered on a physical medium, for example via a CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software; (b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format such as an \u2018about\u2019 file, or included on the start-up screen; (c) software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API); (d) only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays such as \u2018about\u2019 menu, splash screen, etc.; (e) the human readable format of the UDI for the software shall include the application identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI. ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES 1. ORGANISATIONAL AND GENERAL REQUIREMENTS 1.1. Legal status and organisational structure 1.1.1. Each notified body shall be established under the national law of a Member State, or under the law of a third country with which the Union has concluded an agreement in this respect. Its legal personality and status shall be fully documented. Such documentation shall include information about ownership and the legal or natural persons exercising control over the notified body. 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of that organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable to both the notified body and the organisation to which it belongs. 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a third country or is owned by another legal entity, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented. Personnel of those entities performing conformity assessment activities under this Regulation shall be subject to the applicable requirements of this Regulation. 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified body shall be such that they ensure that there is confidence in the performance by the notified body and in the results of the conformity assessment activities it conducts. 1.1.5. The notified body shall clearly document its organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel who may have an influence upon the performance by the notified body upon the results of its conformity assessment activities. 1.1.6. The notified body shall identify the persons in top-level management that have overall authority and responsibility for each of the following: (a) provision of adequate resources for conformity assessment activities; (b) development of procedures and policies for the operation of the notified body; (c) supervision of implementation of the procedures, policies and quality management systems of the notified body; (d) supervision of the notified body's finances; (e) activities and decisions taken by the notified body, including contractual agreements; (f) delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities; (g) interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent authorities, the Commission and other notified bodies. 1.2. Independence and impartiality 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does not preclude the notified body from carrying out conformity assessment activities for competing manufacturers. 1.2.2. The notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities. The notified body shall document and implement a structure and procedures for safeguarding impartiality and for promoting and applying the principles of impartiality throughout its organisation, personnel and assessment activities. Such procedures shall provide for the identification, investigation and resolution of any case in which a conflict of interest may arise including involvement in consultancy services in the field of devices prior to taking up employment with the notified body. The investigation, outcome and its resolution shall be documented. 1.2.3. The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not: (a) be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess, nor the authorised representative of any of those parties. Such restriction shall not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes; (b) be involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which they are designated, nor represent the parties engaged in those activities; (c) engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated; (d) offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity. In particular, they shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of the devices or processes under assessment; and (e) be linked to any organisation which itself provides consultancy services as referred to in the point (d). Such restriction shall not preclude general training activities that are not client specific and that relate to regulation of devices s or to related standards. 1.2.4. Involvement in consultancy services in the field of devices prior to taking up employment with a notified body shall be fully documented at the time of employment, and potential conflicts of interests shall be monitored and resolved in accordance with this Annex. Personnel who were formerly employed by a specific client, or provided consultancy services in the field of devices to that specific client prior to taking up employment with a notified body, shall not be assigned for conformity assessment activities for that specific client or companies belonging to the same group for a period of three years. 1.2.5. The impartiality of notified bodies, of their top-level management and of the assessment personnel shall be guaranteed. The level of the remuneration of the top-level management and assessment personnel of a notified body and subcontractors involved in assessment activities shall not depend on the results of the assessments. Notified bodies shall make publicly available the declarations of interest of their top-level management. 1.2.6. If a notified body is owned by a public entity or institution, independence and absence of any conflict of interests shall be ensured and documented between, on the one hand, the authority responsible for notified bodies and/or the competent authority and, on the other hand, the notified body. 1.2.7. The notified body shall ensure and document that the activities of its subsidiaries or subcontractors or of any associated body, including the activities of its owners do not affect its independence, impartiality or the objectivity of its conformity assessment activities. 1.2.8. The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined in Recommendation 2003/361/EC in relation to fees. 1.2.9. The requirements laid down in this Section shall in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment. 1.3. Confidentiality 1.3.1. The notified body shall have documented procedures in place ensuring that its personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect the confidentiality of the information which comes into its possession during the performance of the conformity assessment activities, except when disclosure is required by law. 1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks under this Regulation or any provision of national law giving effect to it, except in relation to the authorities responsible for notified bodies, competent authorities for devices in the Member States or the Commission. Proprietary rights shall be protected. The notified body shall have documented procedures in place in respect of the requirement of this Section. 1.4. Liability 1.4.1. The notified body shall take out appropriate liability insurance for its conformity assessment activities, unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for their conformity assessment. 1.4.2. The scope and overall financial value of the liability insurance shall correspond to the level and geographic scope of activities of the notified body and be commensurate with the risk profile of the devices certified by the notified body. The liability insurance shall cover cases where the notified body may be obliged to withdraw, restrict or suspend certificates. 1.5. Financial requirements The notified body shall have at its disposal the financial resources required to conduct its conformity assessment activities within its scope of designation and related business operations. It shall document and provide evidence of its financial capacity and its long-term economic viability, taking into account, where relevant, any specific circumstances during an initial start-up phase. 1.6. Participation in coordination activities 1.6.1. The notified body shall participate in, or ensure that its assessment personnel is informed of any relevant standardisation activities and in the activities of the notified body coordination group referred to in Article 49 of Regulation (EU) 2017/745 and that its assessment and decision-making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation. 1.6.2. The notified body shall take into consideration guidance and best practice documents. 2. QUALITY MANAGEMENT REQUIREMENTS 2.1. The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation. 2.2. The quality management system of the notified body shall address at least the following: (a) management system structure and documentation, including policies and objectives for its activities; (b) policies for assignment of activities and responsibilities to personnel; (c) assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management; (d) the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures; (e) control of documents; (f) control of records; (g) management reviews; (h) internal audits; (i) corrective and preventive actions; (j) complaints and appeals; (k) continuous training. Where documents are used in various languages, the notified body shall ensure and control that they have the same content. 2.3. The top-level management of the notified body shall ensure that the quality management system is fully understood, implemented and maintained throughout the notified body organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this Regulation. 2.4. The notified body shall require all personnel to formally commit themselves by a signature or equivalent to comply with the procedures defined by the notified body. That commitment shall cover aspects relating to confidentiality and to independence from commercial and other interests, and any existing or prior association with clients. The personnel shall be required to complete written statements indicating their compliance with confidentiality, independence and impartiality principles. 3. RESOURCE REQUIREMENTS 3.1. General 3.1.1. Notified bodies shall be capable of carrying out all the tasks falling to them under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility. In particular, notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated. Such requirement presupposes at all times and for each conformity assessment procedure and each type of devices in relation to which they have been designated, that the notified body has permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant devices and the corresponding technologies. Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, performance evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular those set out in Annex I. A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is designated. The notified body shall have sufficient internal competence to critically evaluate assessments conducted by external expertise. Tasks which a notified body is precluded from subcontracting are set out in Section 4.1. Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices shall have appropriate knowledge to set up and operate a system for the selection of assessment and verification staff, for verification of their competence, for authorisation and allocation of their tasks, for organisation of their initial and ongoing training, and for their assignment of their duties and monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification operations are competent to fulfil the tasks required of them. The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices. 3.1.2. The notified body shall ensure that personnel involved in conformity assessment activities maintain their qualification and expertise by implementing a system for exchange of experience and a continuous training and education programme. 3.1.3. The notified body shall clearly document the extent and limits of duties and responsibilities and the level of authorisation of to the personnel, including any subcontractors and external experts involved in conformity assessment activities and inform those personnel accordingly. 3.2. Qualification criteria in relation to personnel 3.2.1. The notified body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training. The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review, decision-making, and batch release, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics and performance evaluation, covered by the scope of designation. 3.2.2. The qualification criteria referred to in Section 3.2.1 shall refer to the scope of the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 38(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description. Specific qualification criteria shall be defined at least for the assessment of: \u2014 biological safety, \u2014 performance evaluation, \u2014 devices for self and near patient testing, \u2014 companion diagnostics, \u2014 functional safety, \u2014 software, \u2014 packaging, and \u2014 the different types of sterilisation processes. 3.2.3. The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted. They shall have proven knowledge and experience in all of the following: \u2014 Union devices legislation and relevant guidance documents; \u2014 the conformity assessment procedures provided for in this Regulation; \u2014 a broad base of knowledge of device technologies and the design and manufacture of devices; \u2014 the notified body's quality management system, related procedures and the required qualification criteria; \u2014 training relevant to personnel involved in conformity assessment activities in relation to devices; \u2014 adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body. 3.2.4. The notified body shall have permanent availability of personnel with relevant clinical expertise and where possible such personnel shall be employed by the notified body itself. Such personnel shall be integrated throughout the notified body's assessment and decision-making process in order to: \u2014 identify when specialist input is required for the assessment of the performance evaluation conducted by the manufacturer and identify appropriately qualified experts; \u2014 appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonised standards and ensure that the external clinical experts are fully aware of the context and implications of their assessment and the advice they provide; \u2014 be able to review and scientifically challenge the clinical data contained within the performance evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment of the performance evaluation presented by the manufacturer; \u2014 be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's performance evaluation; \u2014 be able to ascertain the comparability and consistency of the assessments of performance evaluation conducted by clinical experts; \u2014 be able to make an assessment of the manufacturer's performance evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body's decision maker; and \u2014 be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. 3.2.5. The personnel responsible for carrying out product-related reviews, (product reviewers), such as technical documentation reviews or type examination, including aspects such as performance evaluation, biological safety, sterilisation and software validation, shall have all the following proven qualifications: \u2014 successful completion of a university or a technical college degree or an equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences; \u2014 four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of devices or technology to be assessed or related to the scientific aspects to be assessed; \u2014 knowledge of device legislation, including the general safety and performance requirements set out in Annex I; \u2014 appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents; \u2014 appropriate knowledge and experience of risk management and related device standards and guidance documents; \u2014 appropriate knowledge and experience of performance evaluation; \u2014 appropriate knowledge of the devices which they are assessing; \u2014 appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments; \u2014 the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. 3.2.6. The personnel responsible for carrying out audits of the manufacturer's quality management system (site auditors) shall have all of the following proven qualifications: \u2014 successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences; \u2014 four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management; \u2014 appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents; \u2014 appropriate knowledge and experience of risk management and related device standards and guidance documents; \u2014 appropriate knowledge of quality management systems and related l devices standards and guidance documents; \u2014 appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits; \u2014 training in auditing techniques enabling them to challenge quality management systems; \u2014 the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. 3.2.7. The personnel with overall responsibility for final reviews and decision-making on certification shall be employed by the notified body itself and shall not be external experts or be subcontracted. Those personnel, as a group, shall have proven knowledge and comprehensive experience of all of the following: \u2014 devices legislation and relevant guidance documents; \u2014 device conformity assessments relevant to this Regulation; \u2014 the types of qualifications, experience and expertise relevant to device conformity assessment; \u2014 a broad base of knowledge of device technologies, including sufficient experience of the conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices; \u2014 the notified body's quality system, related procedures and the required qualifications for personnel involved; \u2014 the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out. 3.3. Documentation of qualification, training and authorisation of personnel 3.3.1. The notified body shall have a procedure in place to fully document the qualification of each member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where, in exceptional circumstances, the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities. 3.3.2. For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and maintain up to date: \u2014 a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment activities; \u2014 records attesting to the required knowledge and experience for the conformity assessment activity for which they are authorised. The records shall contain a rationale for defining the scope of the responsibilities for each of the assessment personnel and records of the conformity assessment activities carried out by each of them. 3.4. Subcontractors and external experts 3.4.1. Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined component parts of a conformity assessment activity. The subcontracting of the auditing of quality management systems or of product-related reviews as a whole shall not be permitted, nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts working on behalf of the notified body. The notified body in question shall retain full responsibility for being able to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific tasks, for making a decision based on a subcontractor's assessment and for the work conducted by subcontractors and experts on its behalf. The following activities may not be subcontracted by notified bodies: \u2014 review of the qualifications and monitoring of the performance of external experts; \u2014 auditing and certification activities where the subcontracting in question is to auditing or certification organisations; \u2014 allocation of work to external experts for specific conformity assessment activities; \u2014 final review and decision-making functions. 3.4.2. Where a notified body subcontracts certain conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place, and shall ensure that: \u2014 the subcontractor meets the relevant requirements of this Annex; \u2014 subcontractors and external experts do not further subcontract work to organisations or personnel; \u2014 the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent. Any subcontracting or consultation of external personnel shall be properly documented, shall not involve any intermediaries, and shall be subject to a written agreement covering, among other things, confidentiality and conflicts of interest. The notified body in question shall take full responsibility for the tasks performed by subcontractors. 3.4.3. Where subcontractors or external experts are used in the context of a conformity assessment, in particular regarding novel devices or technologies, the notified body in question shall have adequate internal competence in each product area for which it is designated that is adequate for the purpose of leading the overall conformity assessment, verifying the appropriateness and validity of expert opinions and making decisions on certification. 3.5. Monitoring of competences, training and exchange of experience 3.5.1. The notified body shall establish procedures for the initial evaluation and on-going monitoring of the competence, conformity assessment activities and performance of all internal and external personnel and subcontractors, involved in conformity assessment activities. 3.5.2. Notified bodies shall review at regular intervals, the competence of their personnel, identify training needs and draw up a training plan to maintain the required level of qualification and knowledge of individual personnel. That review shall as a minimum, verify that personnel: \u2014 are aware of the Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities referred to in Section 1.6; \u2014 take part in the internal exchange of experience and the continuous training and education programme referred to in Section 3.1.2. 4. PROCESS REQUIREMENTS 4.1. General The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of each conformity assessment activity for which it is designated, comprising the individual steps from pre-application activities up to decision making and surveillance and taking into account, when necessary, the respective specificities of the devices. The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the internal activities of notified bodies and shall not be subcontracted. 4.2. Notified body quotations and pre-application activities The notified body shall (a) publish a publicly available description of the application procedure by which manufacturers can obtain certification from it. That description shall include which languages are acceptable for submission of documentation and for any related correspondence; (b) have documented procedures relating to, and documented details about, fees charged for specific conformity assessment activities and any other financial conditions relating to notified bodies' assessment activities for devices;, (c) have documented procedures in relation to advertising of its conformity assessment services. Those procedures shall ensure that advertising or promotional activities in no way imply or are capable of leading to an inference that their conformity assessment will offer manufacturers earlier market access or be quicker, easier or less stringent than that of other notified bodies; (d) have documented procedures requiring the review of pre-application information including the preliminary verification that the product is covered by this Regulation and its classification prior to issuing any quotation to the manufacturer relating to a specific conformity assessment; (e) ensure that all contracts relating to the conformity assessment activities covered by this Regulation are concluded directly between the manufacturer and the notified body and not with any other organisation. 4.3. Application review and contract The notified body shall require a formal application signed by a manufacturer or an authorised representative containing all of the information and the manufacturer's declarations required by the relevant conformity assessment as referred to in Annexes IX to XI. The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both parties. It shall be kept by the notified body. This contract shall have clear terms and conditions and contain obligations that enable the notified body to act as required under this Regulation, including an obligation on the manufacturer to inform the notified body of vigilance reports, the right of the notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its information obligations. The notified body shall have documented procedures to review applications, addressing: (a) the completeness of those applications with respect to the requirements of the relevant conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought, (b) the verification of the qualification of products covered by those applications as devices and their respective classifications, (c) whether the conformity assessment procedures chosen by the applicant are applicable to the device in question under this Regulation, (d) the ability of the notified body to assess the application based on its designation, and (e) the availability of sufficient and appropriate resources. The outcome of each review of an application shall be documented. Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 52 and shall be accessible to other notified bodies. 4.4. Allocation of resources The notified body shall have documented procedures to ensure that all conformity assessment activities are conducted by appropriately authorised and qualified personnel who are sufficiently experienced in the evaluation of the devices, systems and processes and related documentation that are subject to conformity assessment. For each application, the notified body shall determine the resources needed and identify one individual responsible for ensuring that the assessment of that application is conducted in accordance with the relevant procedures and for ensuring that the appropriate resources including personnel are utilised for each of the tasks of the assessment. The allocation of tasks required to be carried out as part of the conformity assessment and any changes subsequently made to this allocation shall be documented. 4.5. Conformity assessment activities 4.5.1. General The notified body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific fields. The notified body shall have expertise, facilities and documented procedures that are sufficient to effectively conduct the conformity assessment activities for which the notified body in question is designated, taking account of the relevant requirements set out in Annexes IX to XI and in particular the following requirements: \u2014 to appropriately plan the conduct of each individual project, \u2014 to ensure that the composition of the assessment teams is such that there is sufficient experience in relation to the technology concerned, and that there is continuous objectivity and independence, and to provide for rotation of the members of the assessment team at appropriate intervals, \u2014 to specify the rationale for fixing time limits for completion of conformity assessment activities, \u2014 to assess the manufacturer's technical documentation and the solutions adopted to meet the requirements laid down in Annex I, \u2014 to review the manufacturer's procedures and documentation relating to performance evaluation, \u2014 to address the interface between the manufacturer's risk management process and its appraisal and analysis of the performance evaluation and to evaluate their relevance for the demonstration of conformity with the relevant requirements in Annex I, \u2014 to carry out the \u2018specific procedures\u2019 referred to in Section 5 of Annex IX, \u2014 in the case of class B or C devices, to assess the technical documentation of devices selected on a representative basis, \u2014 to plan and periodically carry out appropriate surveillance audits and assessments, to carry out or request certain tests to verify the proper functioning of the quality management system and to perform unannounced on site audits, \u2014 relating to the sampling of devices verify that the manufactured device is in conformity with the technical documentation; such requirements shall define the relevant sampling criteria and testing procedure prior to sampling, \u2014 to evaluate and verify a manufacturer's compliance with relevant Annexes. The notified body shall, where relevant, take into consideration available CS, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance. 4.5.2. Quality management system auditing (a) As part of the assessment of the quality management system a, a notified body shall prior to an audit and in accordance with its documented procedures: \u2014 assess the documentation submitted in accordance with the relevant conformity assessment Annex, and draw up an audit programme which clearly identifies the number and sequence of activities required to demonstrate complete coverage of a manufacturer's quality management system and to determine whether it meets the requirements of this Regulation, \u2014 identify links between and allocation of responsibilities among, the various manufacturing sites, and identify relevant suppliers and/or subcontractors of the manufacturer, and consider the need to specifically audit any of those suppliers or subcontractors or both, \u2014 clearly define, for each audit identified in the audit programme, the objectives, criteria and scope of the audit, and draw up an audit plan that adequately addresses and takes account of the specific requirements for the devices, technologies and processes involved, \u2014 draw up and keep up to date, for class B and class C devices, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer's application. That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate, \u2014 select and assign appropriately qualified and authorised personnel for conducting the individual audits. The respective roles, responsibilities and authorities of the team members shall be clearly defined and documented. (b) Based on the audit programme it has drawn up, the notified body shall, in accordance with its documented procedures: \u2014 audit the manufacturer's quality management system in order to verify that the quality management system ensures that the devices covered conform to the relevant provisions of this Regulation which apply to devices at every stage, from design through final quality control to ongoing surveillance, and shall determine whether the requirements of this Regulation are met, \u2014 based on relevant technical documentation, and in order to determine whether the manufacturer meets the requirements referred to in the relevant conformity assessment Annex, review and audit the manufacturer's processes and subsystems,\u2013 in particular for: \u2014 design and development, \u2014 production and process controls, \u2014 product documentation, \u2014 purchasing controls including verification of purchased devices, \u2014 corrective and preventive actions including for post-market surveillance, and \u2014 PMPF, \u2014 and review and audit requirements and provisions adopted by the manufacturer, including those in relation to fulfilling the general safety and performance requirements set out in Annex I, \u2014 the documentation shall be sampled in such as a manner as to reflect the risks associated with the intended use of the device, the complexity of the manufacturing technologies, the range and classes of devices produced and any available post-market surveillance information, \u2014 if not already covered by the audit programme, audit the control of processes on the premises of the manufacturer's suppliers, when the conformity of finished devices is significantly influenced by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient control over its suppliers, \u2014 conduct assessments of the technical documentation based on its sampling plan and taking account of Section 4.5.4. for performance evaluation, \u2014 the notified body shall ensure that audit findings are appropriately and consistently classified in accordance with the requirements of this Regulation and with relevant standards, or with best practice documents developed or adopted by the MDCG. 4.5.3. Product verification Assessment of the technical documentation For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX, notified bodies shall have sufficient expertise, facilities and documented procedures for: \u2014 the allocation of appropriately qualified and authorised personnel for the examination of individual aspects, such as use of the device, biocompatibility, performance evaluation, risk management and sterilisation, and \u2014 the assessment of conformity of the design with this Regulation, and taking account of Sections 4.5.4. and 4.5.5. This assessment shall include the examination of the implementation by manufacturers of incoming, in-process and final checks and the results thereof. If further tests or other evidence is required for the assessment of conformity with the requirements of this Regulation, the notified body in question shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests. Type-examinations The notified body shall have documented procedures, sufficient expertise and facilities for the type-examination of devices in accordance with Annex X including the capacity to: \u2014 examine and assess the technical documentation, taking account of Sections 4.5.4. and 4.5.5, and verify that the type has been manufactured in conformity with that documentation; \u2014 establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility; \u2014 document its rationale for the selection of those parameters; \u2014 carry out the appropriate examinations and tests in order to verify that the solutions adopted by the manufacturer meet the general safety and performance requirements set out in Annex I. Such examinations and tests shall include all tests necessary to verify that the manufacturer has in fact applied the relevant standards it has opted to use; \u2014 agree with the applicant as to where the necessary tests will be performed if they are not to be carried out directly by the notified body; \u2014 assume full responsibility for test results. Test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer. Verification by examination and testing of every product batch The notified body shall: (a) have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product batch in accordance with Annexes IX and XI; (b) establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility in order to: \u2014 verify, for class C devices, the conformity of the device with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to those devices, \u2014 confirm, for class B devices, the conformity with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to those devices, (c) document its rationale for the selection of the parameters referred to in point (b); (d) have documented procedures to carry out the appropriate assessments and tests in order to verify the conformity of the device with the requirements of this Regulation by examining and testing every product batch as specified in Section 5 of Annex XI; (e) have documented procedures providing for the reaching of an agreement with the applicant concerning when and where necessary tests that are not to be carried out by the notified body itself are to be performed; (f) assume full responsibility for test results in accordance with documented procedures; test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer. 4.5.4. Performance evaluation assessment The assessment by notified bodies of procedures and documentation shall address the results of literature searches and all validation, verification and testing performed and conclusions drawn, and shall typically include considering the use of alternative materials and substances and take account of the packaging, stability including shelf life of the finished device. Where no new testing has been undertaken by a manufacturer or where there have been deviations from procedures, the notified body in question shall critically examine the justification presented by the manufacturer. The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to performance evaluation both for initial conformity assessment and on an ongoing basis. The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address: (a) the planning, conduct, assessment, reporting and updating of the performance evaluation as referred to in Annex XIII, (b) post-market surveillance and post-market performance follow up, (c) the interface with the risk management process, (d) the appraisal and analysis of the available data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I, (e) the conclusions drawn with regard to the clinical evidence and drawing up of the performance evaluation report. The procedures referred to in the second paragraph shall take into consideration available CS, guidance and best practice documents. The notified body's assessment of performance evaluations as referred to in Annex XIII shall cover: \u2014 the intended use specified by the manufacturer and claims for the device defined by it, \u2014 the planning of the performance evaluation, \u2014 the methodology for the literature search, \u2014 relevant documentation from the literature search, \u2014 the performance studies, \u2014 post-market surveillance and post-market performance follow up, \u2014 validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability and conclusions data from equivalent and similar devices, \u2014 the performance evaluation report, \u2014 justifications in relation to non-performance of performance studies or PMPF. In relation to data from performance studies included within the performance evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved performance study plan. The notified body shall ensure that the performance evaluation adequately addresses the relevant safety and performance requirements provided for in Annex I, that it is appropriately aligned with the risk management requirements and that it is conducted in accordance with Annex XIII and that it is appropriately reflected in the information provided relating to the device. 4.5.5. Specific Procedures The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to in Section 5 of Annex IX, for which they are designated. In the case of companion diagnostics, the notified body shall have documented procedures in place that aim to fulfil the requirements of this Regulation in relation to consultation of the EMA or a medicinal products competent authority during its assessment of such types of device. 4.6. Reporting The notified body shall: \u2014 ensure that all steps of the conformity assessment are documented so that the conclusions of the assessment are clear and demonstrate compliance with the requirements of this Regulation and can represent objective evidence of such compliance to persons that are not themselves involved in the assessment, for example personnel in designating authorities, \u2014 ensure that records that are sufficient to provide a discernible audit trail are available for quality management system audits, \u2014 clearly document the conclusions of its assessment of performance evaluation in a performance evaluation assessment report, \u2014 for each specific project, provide a detailed report which shall be based on a standard format containing a minimum set of elements determined by the MDCG. The report of the notified body shall: \u2014 clearly document the outcome of its assessment and draw clear conclusions from the verification of the manufacturer's conformity with the requirements of this Regulation, \u2014 make a recommendation for a final review and for a final decision to be taken by the notified body; this recommendation shall be signed off by the member of personnel responsible in the notified body, \u2014 be provided to the manufacturer in question. 4.7. Final review The notified body shall prior to making a final decision: \u2014 ensure that the personnel assigned for the final review and decision making on specific projects are appropriately authorised and are different from the personnel who have conducted the assessments, \u2014 verify that the report or reports and supporting documentation needed for decision making, including concerning resolution of non-conformities noted during assessment, are complete and sufficient with respect to the scope of the application, and \u2014 verify whether there are any unresolved non-conformities preventing issuance of a certificate. 4.8. Decisions and certifications The notified body shall have documented procedures for decision-making including as regards the allocation of responsibilities for the issuance, suspension, restriction and withdrawal of certificates. Those procedures shall include the notification requirements laid down in Chapter V of this Regulation. The procedures shall allow the notified body in question to: \u2014 decide, based on the assessment documentation and additional information available whether the requirements of this Regulation are fulfilled, \u2014 decide, based on the results of its assessment of the performance evaluation and risk management whether the post-market surveillance plan, including the PMPF plan, is adequate, \u2014 decide on specific milestones for further review by the notified body of the up to date performance evaluation, \u2014 decide whether specific conditions or provisions need to be defined for the certification, \u2014 decide, based on the novelty, risk classification, performance evaluation and conclusions from the risk analysis of the device, on a period of certification not exceeding five years, \u2014 clearly document decision making and approval steps including approval by signature of the members of personnel responsible, \u2014 clearly document responsibilities and mechanisms for communication of decisions, in particular, where the final signatory of a certificate differs from the decision maker or decision makers or does not fulfil the requirements laid down in Section 3.2.7., \u2014 issue a certificate or certificates in accordance with the minimum requirements laid down in Annex XII for a period of validity not exceeding five years and shall indicate whether there are specific conditions or limitations associated with the certification, \u2014 issue a certificate or certificates for the applicant alone and shall not issue certificates covering multiple entities, \u2014 ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that they are entered into the electronic system referred to in Article 52. 4.9. Changes and modifications The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to the manufacturers' information obligations and the assessment of changes to: \u2014 the approved quality management system or systems or to the product-range covered, \u2014 the approved design of a device, \u2014 the approved type of a device, \u2014 any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.5. The procedures and contractual arrangements referred to in the first paragraph shall include measures for checking the significance of the changes referred to in the first paragraph. In accordance with its documented procedures, the notified body in question shall: \u2014 ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and relevant information relating to such changes, \u2014 assess the changes proposed and verify whether, after these changes, the quality management system, or the design of a device or type of a device, still meets the requirements of this Regulation, \u2014 notify the manufacturer of its decision and provide a report or, as applicable, a supplementary report, which shall contain the justified conclusions of its assessment. 4.10. Surveillance activities and post-certification monitoring The notified body shall have documented procedures: \u2014 defining how and when surveillance activities of manufacturers are to be conducted. Those procedures shall include arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at defined intervals, \u2014 for screening relevant sources of scientific and clinical data and post-market information relating to the scope of their designation. Such information shall be taken into account in the planning and conduct of surveillance activities, \u2014 to review vigilance data to which they have access under to Article 87 in order to estimate its impact, if any, on the validity of existing certificates. The results of the evaluation and any decisions taken shall be thoroughly documented. The notified body in question shall, upon receipt of information about vigilance cases from a manufacturer or competent authorities, decide on which of the following options to apply: \u2014 not to take action on the basis that the vigilance case is clearly not related to the certification granted, \u2014 observe the manufacturer's and competent authorities' activities and the results of the manufacturer's investigation so as to determine whether the certification granted is at risk or whether adequate corrective action has been taken, \u2014 perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits and product testing, where it is likely that the certification granted is at risk, \u2014 increase the frequency of surveillance audits, \u2014 review specific products or processes on the occasion of the next audit of the manufacturer, or \u2014 take any other relevant measure. In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to: \u2014 conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned and conducted in line with the relevant requirements in Section 4.5., \u2014 ensure that it adequately assesses the manufacturer's documentation on, and application of, the provisions on vigilance, the post-market surveillance and PMPF, \u2014 sample and test devices and technical documentation, during audits, according to pre-defined sampling criteria and testing procedures to ensure that the manufacturer continuously applies the approved quality management system, \u2014 ensure that the manufacturer complies with the documentation and information obligations laid down in the relevant Annexes and that its procedures take into account best practices in the implementation of quality management systems, \u2014 ensure that the manufacturer does not use quality management system or device approvals in a misleading manner, \u2014 gather sufficient information to determine if the quality management system continues to comply with the requirements of this Regulation, \u2014 ask the manufacturer, if non-conformities are detected, for corrections, corrective actions, and where applicable preventive actions, and \u2014 where necessary, impose specific restrictions on the relevant certificate, or suspend or withdraw it. The notified body shall, if listed as part of the conditions for certification: \u2014 conduct an in-depth review of the performance evaluation as most recently updated by the manufacturer based on the manufacturer's post-market surveillance, on its PMPF and on clinical literature relevant to the condition being treated with the device or on clinical literature relevant to similar devices, \u2014 clearly document the outcome of the in-depth review and address any specific concerns to the manufacturer or impose any specific conditions on it, \u2014 ensure that the performance evaluation as most recently updated is appropriately reflected in the instructions for use and, where applicable, the summary of safety and performance. 4.11. Re-certification The notified body shall have documented procedures in place relating to the re-certification reviews and the renewal of certificates. Re-certification of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates shall occur at least every five years. The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including: (a) all changes to the originally approved device, including changes not yet notified, (b) experience gained from post-market surveillance, (c) experience from risk-management, (d) experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I, (e) experience from reviews of the performance evaluation, including the results of any performance studies and PMPF, (f) changes to the requirements, to components of the device or to the scientific or regulatory environment, (g) changes to applied or new harmonised standards, CS or equivalent documents, and (h) changes in medical, scientific and technical knowledge, such as: \u2014 new treatments, \u2014 changes in test methods, \u2014 new scientific findings on materials and components, including findings on their biocompatibility, \u2014 experience from studies on comparable devices, \u2014 data from registers and registries, \u2014 experience from performance studies with comparable devices. The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMPF activities undertaken since the previous certification or re-certification, including appropriate updates to manufacturers' performance evaluation reports. For the decision on the re-certification, the notified body in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps to be taken for certification, such as application and application review. ANNEX VIII CLASSIFICATION RULES 1. IMPLEMENTING RULES 1.1. Application of the classification rules shall be governed by the intended purpose of the devices. 1.2. If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. 1.3. Accessories for an in vitro diagnostic medical device shall be classified in their own right separately from the device with which they are used. 1.4. Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right. 1.5. Calibrators intended to be used with a device shall be classified in the same class as the device. 1.6. Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes shall be classified in the same class as the device. 1.7. The manufacturer shall take into consideration all classification and implementation rules in order to establish the proper classification for the device. 1.8. Where a manufacturer states multiple intended purposes for a device, and as a result the device falls into more than one class, it shall be classified in the higher class. 1.9. If several classification rules apply to the same device, the rule resulting in the higher classification shall apply. 1.10. Each of the classification rules shall apply to first line assays, confirmatory assays and supplemental assays. 2. CLASSIFICATION RULES 2.1. Rule 1 Devices intended to be used for the following purposes are classified as class D: \u2014 detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration; \u2014 detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation; \u2014 determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management. 2.2. Rule 2 Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers: \u2014 ABO system [A (ABO1), B (ABO2), AB (ABO3)]; \u2014 Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]; \u2014 Kell system [Kel1 (K)]; \u2014 Kidd system [JK1 (Jka), JK2 (Jkb)]; \u2014 Duffy system [FY1 (Fya), FY2 (Fyb)]; in which case they are classified as class D. 2.3. Rule 3 Devices are classified as class C if they are intended: (a) for detecting the presence of, or exposure to, a sexually transmitted agent; (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation; (c) for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual's offspring; (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents; (e) for determining infective disease status or immune status, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring; (f) to be used as companion diagnostics; (g) to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring; (h) to be used in screening, diagnosis, or staging of cancer; (i) for human genetic testing; (j) for monitoring of levels of medicinal products, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring; (k) for management of patients suffering from a life-threatening disease or condition; (l) for screening for congenital disorders in the embryo or foetus; (m) for screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities. 2.4. Rule 4 (a) Devices intended for self-testing are classified as class C, except for devices for the detection of pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine, which are classified as class B. (b) Devices intended for near-patient testing are classified in their own right. 2.5. Rule 5 The following devices are classified as class A: (a) products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination; (b) instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures; (c) specimen receptacles. 2.6. Rule 6 Devices not covered by the above-mentioned classification rules are classified as class B. 2.7. Rule 7 Devices which are controls without a quantitative or qualitative assigned value are classified as class B. ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION CHAPTER I QUALITY MANAGEMENT SYSTEM 1. The manufacturer shall establish, document and implement a quality management system, as described in Article 10(8), and maintain its effectiveness throughout the life cycle of the devices concerned. The manufacturer shall ensure the application of the quality management system as specified in Section 2, and shall be subject to audit as laid down in Sections 2.3 and 2.4 and to surveillance as specified in Section 3. 2. Quality management system assessment 2.1. The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include: \u2014 the name of the manufacturer and address of its registered place of business and any additional manufacturing site covered by the quality management system, and, if the manufacturer's application is lodged by its authorised representative the name of the authorised representative and the address of the authorised representative's registered place of business, \u2014 all relevant information on the device or group of devices covered by the quality management system, \u2014 a written declaration that no application has been lodged with any other notified body for the same device-related quality management system, or information about any previous application for the same device-related quality management system, \u2014 a draft of an EU declaration of conformity in accordance with Article 17 and Annex IV for the device model covered by the conformity assessment procedure, \u2014 the documentation on the manufacturer's quality management system, \u2014 a documented description of the procedures in place to fulfil the obligations arising from by the quality management system and required under this Regulation and of the undertaking by the manufacturer in question to apply those procedures, \u2014 a description of the procedures in place to ensure that the quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures, \u2014 the documentation on the manufacturer's post-market surveillance system, and, where applicable, on the PMPF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87, \u2014 a description of the procedures in place to keep up to date the post-market surveillance system and, where applicable, the PMPF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87, as well as the undertaking by the manufacturer to apply those procedures, \u2014 documentation on the performance evaluation plan, and \u2014 a description of the procedures in place to keep up to date the performance evaluation plan, taking into account the state of the art. 2.2. Implementation of the quality management system shall ensure compliance with this Regulation. All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records. Moreover, the documentation to be submitted for the assessment of the quality management system shall include an adequate description of, in particular: (a) the manufacturer's quality objectives; (b) the organisation of the business and in particular: \u2014 the organisational structures with the assignment of staff responsibilities in relation to critical procedures, the responsibilities of the managerial staff and their organisational authority, \u2014 the methods of monitoring whether the operation of the quality management system is efficient and in particular the ability of that system to achieve the desired design and device quality, including control of devices which fail to conform, \u2014 where the design, manufacture, and/or final verification and testing of the devices, or parts of any of those processes, is carried out by another party, the methods of monitoring the efficient operation of the quality management system and in particular the type and extent of control applied to the other party, \u2014 where the manufacturer does not have a registered place of business in a Member State, the draft mandate for the designation of an authorised representative and a letter of intention from the authorised representative to accept the mandate; (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices, and the corresponding documentation as well as the data and records arising from those procedures and techniques. Those procedures and techniques shall specifically cover: \u2014 the strategy for regulatory compliance, including processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, choice of, and compliance with, conformity assessment procedures, \u2014 identification of applicable general safety and performance requirements and solutions to fulfil those requirements, taking applicable CS into account and, where opted for, harmonised standards, \u2014 risk management as referred to in Section 3 of Annex I, \u2014 the performance evaluation, pursuant to Article 56 and Annex XIII, including PMPF, \u2014 solutions for fulfilling the applicable specific requirements regarding design and construction, including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I, \u2014 solutions for fulfilling the applicable specific requirements regarding the information to be supplied with the device, in particular the requirements of Chapter III of Annex I, \u2014 the device identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture, and \u2014 management of design or quality management system changes; (d) the verification and quality assurance techniques at the manufacturing stage and in particular the processes and procedures which are to be used, particularly as regards sterilisation, and the relevant documents, and (e) the appropriate tests and trials which are to be carried out before, during and after manufacture, the frequency with which they are to take place, and the test equipment to be used; it shall be possible to trace back adequately the calibration of that test equipment. In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annexes II and III. 2.3. Audit The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 2.2. Where the manufacturer uses a harmonised standard or CS related to a quality management system, the notified body shall assess conformity with those standards or CS. The notified body shall assume that a quality management system which satisfies the relevant harmonised standards or CS conforms to the requirements covered by those standards or CS, unless it duly substantiate not doing so. The audit team of the notified body shall include at least one member with past experience of assessments of the technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such experience is not immediately obvious or applicable, the notified body shall provide a documented rationale for the composition of that team. The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to verify the manufacturing and other relevant processes. Moreover, in the case of class C devices, the quality management system assessment shall be accompanied by the assessment of the technical documentation for devices selected on a representative basis in accordance with provisions in Sections 4.4 to 4.8. In choosing representative samples the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 99 and in particular, the novelty of the technology, the potential impact on the patient and standard medical practice, similarities in design, technology, manufacturing and, where applicable, sterilisation methods, the intended purpose and the results of any previous relevant assessments that have been carried out in accordance with this Regulation. The notified body in question shall document its rationale for the samples taken. If the quality management system conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality management system certificate. The notified body shall notify the manufacturer of tits decision to issue the certificate. The decision shall contain the conclusions of the audit and a reasoned report. 2.4. The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered. The notified body shall assess the changes proposed, determine the need for additional audits and verify whether, after those changes, the quality management system still meets the requirements referred to in Section 2.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits. The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate. 3. Surveillance assessment applicable to class C and class D devices 3.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality management system. 3.2. The manufacturer shall give authorisation to the notified body to carry out all the necessary audits, including on-site audits, and supply it with all relevant information, in particular: \u2014 the documentation on its quality management system, \u2014 the documentation on any findings and conclusions resulting from the application of the post-market surveillance plan, including the PMPF plan, for a representative sample of devices, and of the provisions on vigilance set out in Articles 82 to 87, \u2014 the data stipulated in the part of the quality management system relating to design, such as the results of analyses, calculations, tests and the solutions adopted regarding the risk-management as referred to in Section 4 of Annex I, \u2014 the data stipulated in the part of the quality management system relating to manufacture, such as quality control reports and test data, calibration data, and records on the qualifications of the personnel concerned. 3.3. Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. At the time of such on-site audits, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report. 3.4. The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer and, where appropriate, the site of the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 3.3 or be performed in addition to that surveillance assessment. The notified body shall establish a plan for such unannounced on-site audits but shall not disclose it to the manufacturer. Within the context of such unannounced on-site audits, the notified body shall test an adequate sample of the devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation. Prior to unannounced on-site audits, the notified body shall specify the relevant sampling criteria and testing procedure. Instead of, or in addition to, sampling referred to in the second paragraph, notified bodies shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation. Prior to the sampling, the notified body in question shall specify the relevant sampling criteria and testing procedure. The notified body shall provide the manufacturer in question with an on-site audit report which shall include, if applicable, the result of the sample test. 3.5. In the case of class C devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 of for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the third paragraph of Section 2.3. 3.6. Notified bodies shall ensure that the composition of the assessment team is such that there is sufficient experience with the evaluation of the devices, systems and processes concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals. As a general rule, a lead auditor shall neither lead nor attend audits for more than three consecutive years in respect of the same manufacturer. 3.7. If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it. CHAPTER II ASSESSMENT OF THE TECHNICAL DOCUMENTATION 4. Assessment of the technical documentation of class B, C and D devices and batch verification applicable to class D devices 4.1. In addition to the obligation laid down in Section 2, the manufacturer of devices shall lodge with the notified body an application for the assessment of the technical documentation relating to the device which it plans to place on the market or put into service and which is covered by the quality management system referred to in Section 2. 4.2. The application shall describe the design, manufacture and performance of the device in question. It shall include the technical documentation as referred to in Annexes II and III. In the case of devices for self-testing or near-patient testing, the application shall also include the aspects referred to in point (b) of Section 5.1. 4.3. The notified body shall examine the application by using staff, employed by it, with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests. 4.4. The notified body shall review the clinical evidence presented by the manufacturer in the performance evaluation report and the related performance evaluation that was conducted. The notified body shall use employed device reviewers with sufficient clinical expertise and including external clinical experts with direct and current experience relating to the clinical application of the device in question for the purposes of that review. 4.5. The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity. 4.6. The notified body shall verify that the clinical evidence and the performance evaluation are adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety and performance requirements. That verification shall include consideration of the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training and the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the PMPF plan proposed, where applicable. 4.7. Based on its assessment of the clinical evidence, the notified body shall consider the performance evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMPF data. 4.8. The notified body shall clearly document the outcome of its assessment in the performance evaluation assessment report. 4.9. Before issuing an EU technical documentation assessment certificate, the notified body shall request an EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The verification shall include laboratory tests by the EU reference laboratory as referred to in Article 48(5). In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation, consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 in accordance with the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer. The EU reference laboratory shall provide a scientific opinion within 60 days. The scientific opinion of the EU reference laboratory and, where applicable, the views of the experts consulted, pursuant to the procedure laid down in Article 48(6), and any possible updates shall be included in the documentation of the notified body concerning the device. The notified body shall, when making its decision, give due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views expressed by the experts consulted pursuant to Article 48(6). The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable. 4.10. The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a performance evaluation assessment report. If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate. The certificate shall contain the conclusions of the technical documentation assessment, the conditions of the certificate's validity, the data needed for identification of the approved device, and, where appropriate, a description of the intended purpose of the device. 4.11. Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate, where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate. Where the changes could affect compliance with the CS or with other solutions chosen by the manufacturer which were approved through the EU technical documentation assessment certificate, the notified body shall consult the EU reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CS or with other solutions chosen by the manufacturer, to ensure a level of safety and performance that is at least equivalent, is maintained. The EU reference laboratory shall provide a scientific opinion within 60 days. 4.12. To verify conformity of manufactured class D devices, the manufacturer shall carry out tests on each manufactured batch of devices. After the conclusion of the controls and tests, it shall forward to the notified body, without delay, the relevant reports on those tests. Furthermore, the manufacturer shall make the samples of manufactured batches of devices available to the notified body in accordance with pre-agreed conditions and detailed arrangements which shall include that the notified body or the manufacturer shall send samples of the manufactured batches of devices to the EU reference laboratory, where such a laboratory has been designated in accordance with Article 100, to carry out appropriate tests. The EU reference laboratory shall inform the notified body about its findings. 4.13. The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates. 5. Assessment of the technical documentation of specific types of devices 5.1. Assessment of the technical documentation of class B, C and D devices for self-testing and near-patient testing (a) The manufacturer of class B, C and D devices for self-testing and near-patient testing shall lodge with the notified body an application for the assessment of the technical documentation. (b) The application shall enable the design of the device characteristics and performance(s) to be understood and shall enable conformity with the design-related requirements of this Regulation to be assessed. It shall include: (i) test reports, including results of studies carried out with intended users; (ii) where practicable, an example of the device; if required, the device shall be returned on completion of the technical documentation assessment; (iii) data showing the suitability of the device in view of its intended purpose for self-testing or near patient-testing; (iv) the information to be provided with the device on its label and its instructions for use. The notified body may require the application to be completed by carrying out further tests or by providing further proof to allow assessment of conformity with the requirements of this Regulation. (c) The notified body shall verify the compliance of the device with the relevant requirements set out in Annex I of this Regulation. (d) The notified body shall assess the application, by using staff, employed by it, with proven knowledge and experience regarding the technology concerned and the intended purpose of the device and provide the manufacturer with a technical documentation assessment report. (e) If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate. The certificate shall contain the conclusions of the assessment, the conditions of its validity, the data needed for the identification of the approved devices and, where appropriate, a description of the intended purpose of the device. (f) Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate, where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-mentioned changes, it shall inform the notified body which issued the EU technical documentation assessment certificate thereof. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate. 5.2. Assessment of the technical documentation of companion diagnostics (a) The manufacturer of a companion diagnostic shall lodge with the notified body an application for the assessment of the technical documentation. The notified body shall assess that application in accordance with the procedure laid down in Sections 4.1 to 4.8 of this Annex. (b) The application shall enable the characteristics and performance of the device to be understood, and shall enable conformity with the design-related requirements of this Regulation to be assessed, in particular, with regard to the suitability of the device in relation to the medicinal product concerned. (c) The notified body shall, before issuing an EU technical documentation assessment certificate for the companion diagnostic and on the basis of the draft summary of safety and performance and the draft instructions for use, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as \u2018the medicinal products authority consulted\u2019 depending on which has been consulted under this point, regarding the suitability of the device in relation to the medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex to Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), the notified body shall seek the opinion of the EMA. If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products authority, or the EMA, that is responsible for the authorisation. (d) The medicinal products authority consulted shall provide its opinion, within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a further 60 days on justified grounds. The opinion and any possible update shall be included in the documentation of the notified body concerning the device. (e) The notified body shall give due consideration to the scientific opinion referred to in point (d) when making its decision. The notified body shall convey its final decision to the medicinal products authority consulted. The EU technical documentation assessment certificate shall be delivered in accordance with point (e) of Section 5.1. (f) Before changes affecting the performance and/or the intended use and/or the suitability of the device in relation to the medicinal product concerned are made, the manufacturer shall inform the notified body of the changes. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes and seek the opinion of the medicinal products authority consulted. The medicinal products authority consulted shall give its opinion within 30 days of receipt of the all the necessary documentation regarding the changes. A supplement to the EU technical documentation assessment certificate shall be issued in accordance with point (f) of Section 5.1. CHAPTER III ADMINISTRATIVE PROVISIONS 6. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, it's authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities: \u2014 the EU declaration of conformity, \u2014 the documentation referred to in the fifth indent of Section 2.1. and, in particular, the data and records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2., \u2014 information on the changes referred to in Section 2.4., \u2014 the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and \u2014 the decisions and reports from the notified body as referred to in this Annex. 7. Each Member State shall require that the documentation referred to in Section 6 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period. (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION 1. EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentation and relevant life cycle processes and a corresponding representative sample of the device production envisaged, fulfils the relevant provisions of this Regulation. 2. Application The manufacturer shall lodge an application for assessment with a notified body. The application shall include: \u2014 the name of the manufacturer and the address of its registered place of business and, if the application is lodged by the authorised representative, the name of the authorised representative and the address of its registered place of business, \u2014 the technical documentation referred to in Annexes II and III. The applicant shall make a representative sample of the device production envisaged (\u2018type\u2019) available to the notified body. The notified body may request other samples as necessary, \u2014 in the case of devices for self-testing or near-patient testing, test reports, including results of studies carried out with intended users, and data showing the handling suitability of the device in relation to its intended purpose for self-testing or near patient-testing, \u2014 where practicable, an example of the device. If required, the device shall be returned on completion of the technical documentation assessment; \u2014 data showing the suitability of the device in relation to its intended purpose for self-testing or near-patient testing, \u2014 the information to be provided with the device on its label and its instructions for use, and \u2014 a written declaration that no application has been lodged with any other notified body for the same type, or information about any previous application for the same type that was refused by another notified body or was withdrawn by the manufacturer or its authorised representative before that other notified body made its final assessment. 3. Assessment The notified body shall: (a) examine the application, by using staff with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests; (b) examine and assess the technical documentation for conformity with the requirements of this Regulation that are applicable to the device and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable standards referred to in Article 8 or with applicable CS, and record items not designed on the basis of the relevant standards referred to in Article 8 or of the relevant CS; (c) review the clinical evidence presented by the manufacturer in the performance evaluation report in accordance with Section 1.3.2 of Annex XIII. The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the clinical application of the device in question for the purposes of that review; (d) in circumstances in which the clinical evidence is partly or totally based on data from devices which are claimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity; (e) clearly document the outcome of its assessment in the performance evaluation assessment report referred to in Section 4.8 of Annex IX; (f) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements laid down in this Regulation in the event that the standards referred to in Article 8 or the CS have not been applied. Where the device has to be connected to another device or devices in order to operate as intended, proof shall be provided that it conforms to the general safety and performance requirements when connected to any such device or devices having the characteristics specified by the manufacturer; (g) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised standards, those standards have actually been applied; (h) agree with the applicant on the place where the necessary assessments and tests are to be carried out; (i) draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to (g); (j) in the case of class D devices, request the EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The verification shall include laboratory tests by the EU reference laboratory in accordance with Article 48(5). In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation, consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 following the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer. The EU reference laboratory shall provide a scientific opinion within 60 days. The scientific opinion of the EU reference laboratory and, where the procedure laid down in Article 48(6) is applicable, the views of the experts consulted, and any possible updates shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views expressed by the experts consulted in accordance with Article 48(6), when making its decision. The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable; (k) for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use, of one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as \u2018the medicinal products authority consulted\u2019 depending on which has been consulted under this point) on the suitability of the device in relation to the medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMA. If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the EMA, that is responsible for the authorisation. The medicinal products authority consulted shall deliver its opinion within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a further 60 days on justified grounds. The opinion of the medicinal products authority consulted and any possible update shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the opinion expressed by the medicinal products authority consulted when making its decision. It shall convey its final decision to the medicinal products authority consulted; and (l) draw up an EU type-examination report on the results of the assessments and tests carried out, and scientific opinions provided under, points (a) to (k), including a performance evaluation assessment report for class C or class D devices or covered by the third indent of Section 2. 4. Certificate If the type conforms to this Regulation, the notified body shall issue an EU type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the type examination assessment, the conditions of certificate's validity and the data needed for identification of the type approved. The certificate shall be drawn up in accordance with Annex XII. The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body. 5. Changes to the type 5.1. The applicant shall inform the notified body which issued the EU type-examination certificate of any planned change to the approved type or of its intended purpose and conditions of use. 5.2. Changes to the approved device including limitations of its intended purpose and conditions of use shall require further approval from the notified body which issued the EU type-examination certificate where such changes may affect conformity with the general safety and performance requirements or with the conditions prescribed for use of the product. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU type-examination report. The approval of any change to the approved type shall take the form of a supplement to the EU type-examination certificate. 5.3. Changes to the intended purpose and conditions of use of the approved device, with the exception of limitations of the intended purpose and conditions of use, shall necessitate a new application for a conformity assessment. 5.4. Where the changes could affect the performance claimed by the manufacturer or compliance with the CS or with other solutions chosen by the manufacturer which were approved through the EU type-examination certificate, the notified body shall consult the EU reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained. The EU reference laboratory shall provide a scientific opinion within 60 days. 5.5. Where the changes affect the performance or the intended use of a companion diagnostic approved through the EU type-examination certificate or its suitability in relation to a medicinal product, the notified body shall consult the medicinal products competent authority that was involved in the initial consultation or the EMA. The medicinal products authority consulted shall give its opinion, if any, within 30 days after receipt of the valid documentation regarding the changes. The approval of any change to the approved type shall take the form of a supplement to the initial EU type-examination certificate. 6. Administrative provisions The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, after the last device has been placed on the market, keep at the disposal of the competent authorities: \u2014 the documentation referred to in the second indent of Section 2, \u2014 information on the changes referred to in Section 5, \u2014 copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements. Section 7 of Annex IX shall apply. ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE 1. The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and shall be subject to the surveillance referred to in Section 4. 2. When the manufacturer fulfils the obligations laid down in Section 1, it shall draw up and keep an EU declaration of conformity in accordance with Article 17 and Annex IV for the device covered by the conformity assessment procedure. By issuing an EU declaration of conformity, the manufacturer shall be deemed to ensure, and to declare, that the device concerned meets the requirements of this Regulation which apply to the device, and in the case of class C and class D devices that undergo a type examination, conforms to the type described in the EU type-examination certificate. 3. Quality management system 3.1. The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include: \u2014 all elements listed in Section 2.1 of Annex IX, \u2014 the technical documentation referred to in Annexes II and III for the types approved, \u2014 a copy of the EU type-examination certificates referred to in Section 4 of Annex X; if the EU type-examination certificates have been issued by the same notified body with which the application is lodged, a reference to the technical documentation and its updates and the certificates issued shall also be included in the application. 3.2. Implementation of the quality management system shall be such as to ensure that there is compliance with the type described in the EU type-examination certificate and with the provisions of this Regulation which apply to the devices at each stage. All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records. That documentation shall, in particular, include an adequate description of all elements listed in points (a), (b), (d) and (e) of Section 2.2. of Annex IX. 3.3. The first and second paragraphs of Section 2.3 of Annex IX shall apply. If the quality management system is such that it ensures that the devices conform to the type described in the EU type-examination certificate and conform to the relevant provisions of this Regulation, the notified body shall issue an EU production quality assurance certificate. The notified body shall notify the manufacturer of its decision to issue the certificate. That decision shall contain the conclusions of the notified body's audit and a reasoned assessment. 3.4. Section 2.4 of Annex IX shall apply. 4. Surveillance Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of Annex IX shall apply. 5. Verification of manufactured class D devices 5.1. In the case of class D devices, the manufacturer shall carry out tests on each manufactured batch of devices. After the conclusion of the controls and tests, it shall forward to the notified body without delay the relevant reports on those tests. Furthermore, the manufacturer shall make samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and detailed arrangements which shall include that the notified body or the manufacturer, shall send samples of the manufactured devices or batches of devices to an EU reference laboratory, where such a laboratory has been designated in accordance with Article 100, to carry out appropriate laboratory tests. The EU reference laboratory shall inform the notified body about its findings. 5.2. The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates. 6. Administrative provisions The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities: \u2014 the EU declaration of conformity, \u2014 the documentation referred to in the fifth indent of Section 2.1 of Annex IX, \u2014 the documentation referred to in the eighth indent of Section 2.1 of Annex IX, including the EU type-examination certificate referred to in Annex X, \u2014 information on the changes referred to in Section 2.4 of Annex IX, and \u2014 the decisions and reports from the notified body as referred to in Sections 2.3., 3.3. and 3.4. of Annex IX. Section 7 of Annex IX shall apply. ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY CHAPTER I GENERAL REQUIREMENTS 1. Certificates shall be drawn up in one of the official languages of the Union. 2. Each certificate shall refer to only one conformity assessment procedure. 3. Certificates shall only be issued to one manufacturer. The name and address of the manufacturer included in the certificate shall be the same as that registered in the electronic system referred to in Article 27. 4. The scope of the certificates shall unambiguously describe the device or devices covered: (a) EU technical documentation assessment certificates and EU type-examination certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose as indicated by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI as referred to in Article 24(6). (b) EU quality management system certificates and EU production quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification and the intended purpose. 5. The notified body shall be able to demonstrate on request, which (individual) devices are covered by the certificate. The notified body shall set up a system that enables the determination of the devices, including their classification, covered by the certificate. 6. Certificates shall contain, if applicable, a note that, for the placing on the market of the device or devices it covers, another certificate issued in accordance with this Regulation is required. 7. EU quality management system certificates and EU production quality assurance certificates for class A sterile devices shall include a statement that the audit by the notified body was limited to the aspects of manufacture concerned with securing and maintaining sterile conditions. 8. Where a certificate is supplemented, modified or re-issued, the new certificate shall contain a reference to the preceding certificate and its date of issue with identification of the changes. CHAPTER II MINIMUM CONTENT OF THE CERTIFICATES 1. name, address and identification number of the notified body; 2. name and address of the manufacturer and, if applicable, of the authorised representative; 3. unique number identifying the certificate; 4. if already issued, the SRN of the manufacturer referred to in Article 28(2); 5. date of issue; 6. date of expiry; 7. data needed for the unambiguous identification of the device or devices where applicable as specified in Section 4 of this Annex; 8. if applicable, reference to any previous certificate as specified in Section 8 of Chapter I; 9. reference to this Regulation and the relevant Annex in accordance with which the conformity assessment has been carried out; 10. examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test reports and audit report(s); 11. if applicable, reference to the relevant parts of the technical documentation or other certificates required for the placing on the market of the device or devices covered; 12. if applicable, information about the surveillance by the notified body; 13. conclusions of the notified body's conformity assessment with regard to the relevant Annex; 14. conditions for or limitations to the validity of the certificate; 15. legally binding signature of the notified body in accordance with the applicable national law. ANNEX XIII PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP PART A PERFORMANCE EVALUATION AND PERFORMANCE STUDIES 1. PERFORMANCE EVALUATION Performance evaluation of a device is a continuous process by which data are assessed and analysed to demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended purpose as stated by the manufacturer. To plan, continuously conduct and document a performance evaluation, the manufacturer shall establish and update a performance evaluation plan. The performance evaluation plan shall specify the characteristics and the performance of the device and the process and criteria applied to generate the necessary clinical evidence. The performance evaluation shall be thorough and objective, considering both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the characteristics of the device including the risks, risk class, performance and its intended purpose. 1.1. Performance evaluation plan As a general rule, the performance evaluation plan shall include at least: \u2014 a specification of the intended purpose of the device; \u2014 a specification of the characteristics of the device as described in Section 9 of Chapter II of Annex I and in point (c) of Section 20.4.1. of Chapter III of Annex I; \u2014 a specification of the analyte or marker to be determined by the device; \u2014 a specification of the intended use of the device; \u2014 identification of certified reference materials or reference measurement procedures to allow for metrological traceability; \u2014 a clear identification of specified target patient groups with clear indications, limitations and contra-indications; \u2014 an identification of the general safety and performance requirements as laid down in Sections 1 to 9 of Annex I that require support from relevant scientific validity and analytical and clinical performance data; \u2014 a specification of methods, including the appropriate statistical tools, used for the examination of the analytical and clinical performance of the device and of the limitations of the device and information provided by it; \u2014 a description of the state of the art, including an identification of existing relevant standards, CS, guidance or best practices documents; \u2014 an indication and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the intended purpose or purposes and for the analytical and clinical performance of the device; \u2014 for software qualified as a device, an identification and specification of reference databases and other sources of data used as the basis for its decision making; \u2014 an outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria; \u2014 the PMPF planning as referred to in Part B of this Annex. Where any of the above mentioned elements are not deemed appropriate in the Performance Evaluation Plan due to the specific device characteristics a justification shall be provided in the plan. 1.2. Demonstration of the scientific validity and the analytical and clinical performance: As a general methodological principle the manufacturer shall: \u2014 identify through a systematic scientific literature review the available data relevant to the device and its intended purpose and identify any remaining unaddressed issues or gaps in the data; \u2014 appraise all relevant data by evaluating their suitability for establishing the safety and performance of the device; \u2014 generate any new or additional data necessary to address outstanding issues. 1.2.1. Demonstration of the scientific validity The manufacturer shall demonstrate the scientific validity based on one or a combination of the following sources: \u2014 relevant information on the scientific validity of devices measuring the same analyte or marker; \u2014 scientific (peer-reviewed) literature; \u2014 consensus expert opinions/positions from relevant professional associations; \u2014 results from proof of concept studies; \u2014 results from clinical performance studies. The scientific validity of the analyte or marker shall be demonstrated and documented in the scientific validity report. 1.2.2. Demonstration of the analytical performance The manufacturer shall demonstrate the analytical performance of the device in relation to all the parameters described in point (a) of Section 9.1 of Annex I, unless any omission can be justified as not applicable. As a general rule, the analytical performance shall always be demonstrated on the basis of analytical performance studies. For novel markers or other markers without available certified reference materials or reference measurement procedures, it may not be possible to demonstrate trueness. If there are no comparative methods, different approaches may be used if demonstrated to be appropriate, such as comparison to some other well-documented methods or the composite reference standard. In the absence of such approaches, a clinical performance study comparing performance of the novel device to the current clinical standard practice is required. Analytical performance shall be demonstrated and documented in the analytical performance report. 1.2.3. Demonstration of the clinical performance The manufacturer shall demonstrate the clinical performance of the device in relation to all the parameters described in point (b) of Section 9.1. of Annex I, unless any omission can be justified as not applicable. Demonstration of the clinical performance of a device shall be based on one or a combination of the following sources: \u2014 clinical performance studies; \u2014 scientific peer-reviewed literature; \u2014 published experience gained by routine diagnostic testing. Clinical performance studies shall be performed unless due justification is provided for relying on other sources of clinical performance data. Clinical performance shall be demonstrated and documented in the clinical performance report. 1.3. Clinical evidence and performance evaluation report 1.3.1. The manufacturer shall assess all relevant scientific validity, analytical and clinical performance data to verify the conformity of its device with the general safety and performance requirements as referred to in Annex I. The amount and quality of that data shall allow the manufacturer to make a qualified assessment whether the device will achieve the intended clinical benefit or benefits and safety, when used as intended by the manufacturer. The data and conclusions drawn from this assessment shall constitute the clinical evidence for the device. The clinical evidence shall scientifically demonstrate that the intended clinical benefit or benefits and safety will be achieved according to the state of the art in medicine. 1.3.2. Performance evaluation report The clinical evidence shall be documented in a performance evaluation report. This report shall include the scientific validity report, the analytical performance report, the clinical performance report and an assessment of those reports allowing demonstration of the clinical evidence. The performance evaluation report shall in particular include: \u2014 the justification for the approach taken to gather the clinical evidence; \u2014 the literature search methodology and the literature search protocol and literature search report of a literature review; \u2014 the technology on which the device is based, the intended purpose of the device and any claims made about the device's performance or safety; \u2014 the nature and extent of the scientific validity and the analytical and clinical performance data that has been evaluated; \u2014 the clinical evidence as the acceptable performances against the state of the art in medicine; \u2014 any new conclusions derived from PMPF reports in accordance with Part B of this Annex. 1.3.3. The clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's PMPF plan in accordance with Part B of this Annex, as part of the performance evaluation and the post-market surveillance system referred to in Article 10(9). The performance evaluation report shall be part of the technical documentation. Both favourable and unfavourable data considered in the performance evaluation shall be included in the technical documentation. 2. CLINICAL PERFORMANCE STUDIES 2.1. Purpose of clinical performance studies The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. This information is used to demonstrate compliance with the relevant general safety and performance requirements with respect to clinical performance. When clinical performance studies are conducted, the data obtained shall be used in the performance evaluation process and be part of the clinical evidence for the device. 2.2. Ethical considerations for clinical performance studies Each step in the clinical performance study, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles. 2.3. Methods for clinical performance studies 2.3.1. Clinical performance study design type Clinical performance studies shall be designed in such a way as to maximize the relevance of the data while minimising potential bias. 2.3.2. Clinical performance study plan Clinical performance studies shall be performed on the basis of a clinical performance study plan (CPSP). The CPSP shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study. It shall contain in particular the following information: (a) the single identification number of the clinical performance study, as referred to in Article 66(1); (b) identification of the sponsor, including the name, address of the registered place of business and contact details of the sponsor and, if applicable, the name, address of the registered place of business and contact details of its contact person or legal representative pursuant to Article 58(4) established in the Union; (c) information on the investigator or investigators, namely principal, coordinating or other investigator; qualifications; contact details, and investigation site or sites, such as number, qualification, contact details and, in the case of devices for self-testing, the location and number of lay persons involved; (d) the starting date and scheduled duration for the clinical performance study; (e) identification and description of the device, its intended purpose, the analyte or analytes or marker or markers, the metrological traceability, and the manufacturer; (f) information about the type of specimens under investigation; (g) overall synopsis of the clinical performance study, its design type, such as observational, interventional, together with the objectives and hypotheses of the study, reference to the current state of the art in diagnosis and/or medicine; (h) a description of the expected risks and benefits of the device and of the clinical performance study in the context of the state of the art in clinical practice, and with the exception of studies using left-over samples, the medical procedures involved and patient management; (i) the instructions for use of the device or test protocol, the necessary training and experience of the user, the appropriate calibration procedures and means of control, the indication of any other devices, medical devices, medicinal product or other articles to be included or excluded and the specifications on any comparator or comparative method used as reference; (j) description of and justification for the design of the clinical performance study, its scientific robustness and validity, including the statistical design, and details of measures to be taken to minimise bias, such as randomisation, and management of potential confounding factors; (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justification for any omission; (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined, with justification for any omission; and with the exception of studies using left-over samples the specified clinical outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health and/or public health management decisions; (m) information on the performance study population: specifications of the subjects, selection criteria, size of performance study population, representativity of target population and, if applicable, information on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects; (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or disease registries etc. with description of reliability and representativity and statistical analysis approach; assurance of relevant method for determining the true clinical status of patient specimens; (o) monitoring plan; (p) data management; (q) decision algorithms; (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP, with a clear prohibition of use of waivers from the CPSP; (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the device used in the clinical performance study and the return of unused, expired or malfunctioning devices; (t) statement of compliance with the recognised ethical principles for medical research involving humans and the principles of good clinical practice in the field of clinical performance studies as well as with the applicable regulatory requirements; (u) description of the informed consent process, including a copy of the patient information sheet and consent forms; (v) procedures for safety recording and reporting, including definitions of recordable and reportable events, and procedures and timelines for reporting; (w) criteria and procedures for suspension or early termination of the clinical performance study; (x) criteria and procedures for follow up of subjects following completion of a performance study, procedures for follow up of subjects in the case of suspension or early termination, procedures for follow up of subjects who have withdrawn their consent and procedures for subjects lost to follow up; (y) procedures for communication of test results outside the study, including communication of test results to the performance study subjects; (z) policy as regards the establishment of the clinical performance study report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 2.2; (aa) list of the technical and functional features of the device indicating those that are covered by the performance study; (ab) bibliography. If part of the information referred to in the second paragraph is submitted in a separate document, it shall be referenced in the CPSP. For studies using left-over samples, points (u), (x), (y) and (z) shall not apply. Where any of the elements referred to in the second paragraph are not deemed appropriate for inclusion in the CPSP due to the specific study design chosen, such as use of left-over samples versus interventional clinical performance studies, a justification shall be provided. 2.3.3. Clinical performance study report A clinical performance study report, signed by a medical practitioner or any other authorised person responsible, shall contain documented information on the clinical performance study protocol plan, results and conclusions of the clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias and clinically relevant. The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents. The report shall also include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale. 3. OTHER PERFORMANCE STUDIES By analogy, the performance study plan referred to in Section 2.3.2, and the performance study report, referred to in Section 2.3.3, shall be documented for other performance studies than clinical performance studies. PART B POST-MARKET PERFORMANCE FOLLOW-UP 4. PMPF shall be understood to be a continuous process that updates the performance evaluation referred to in Article 56 and Part A of this Annex and shall be specifically addressed in the manufacturer's post-market surveillance plan. When conducting PMPF, the manufacturer shall proactively collect and evaluate performance and relevant scientific data from the use of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety, performance and scientific validity throughout the expected lifetime of the device, of ensuring the continued acceptability of the benefit-risk ratio and of detecting emerging risks on the basis of factual evidence. 5. PMPF shall be performed pursuant to a documented method laid down in a PMPF plan. 5.1. The PMPF plan shall specify the methods and procedures for proactively collecting and evaluating safety, performance and scientific data with the aim of: (a) confirming the safety and performance of the device throughout its expected lifetime, (b) identifying previously unknown risks or limits to performance and contra-indications, (c) identifying and analysing emergent risks on the basis of factual evidence, (d) ensuring the continued acceptability of the clinical evidence and of the benefit-risk ratio referred to in Sections 1 and 8 of Chapter I of Annex I, and (e) identifying possible systematic misuse. 5.2. The PMPF plan shall include at least: (a) the general methods and procedures of the PMPF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of performance or scientific data; (b) the specific methods and procedures of PMPF to be applied, such as ring trials and other quality assurance activities, epidemiological studies, evaluation of suitable patient or disease registers, genetic databanks or post-market clinical performance studies; (c) a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b); (d) a reference to the relevant parts of the performance evaluation report referred to in Section 1.3 of this Annex and to the risk management referred to in Section 3 of Annex I; (e) the specific objectives to be addressed by the PMPF; (f) an evaluation of the performance data relating to equivalent or similar devices, and the current state of the art; (g) reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMPF, and; (h) a detailed and adequately justified time schedule for PMPF activities, such as analysis of PMPF data and reporting, to be undertaken by the manufacturer. 6. The manufacturer shall analyse the findings of the PMPF and document the results in a PMPF evaluation report that shall update the performance evaluation report and be part of the technical documentation. 7. The conclusions of the PMPF evaluation report shall be taken into account for the performance evaluation referred to in Article 56 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMPF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them. 8. If PMPF is not deemed appropriate for a specific device then a justification shall be provided and documented within the performance evaluation report. ANNEX XIV INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES CHAPTER I DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES For devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies, the sponsor shall draw up and submit the application in accordance with Article 58 accompanied by the following documents: 1. Application form The application form shall be duly filled in, containing the following information: 1.1. name, address and contact details of the sponsor and, if applicable, name, address and contact details of its contact person or legal representative in accordance with Article 58(4) established in the Union; 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for performance evaluation and, if applicable, of its authorised representative; 1.3. title of the performance study; 1.4. single identification number in accordance with Article 66(1); 1.5. status of the performance study, such as. the first submission, resubmission, significant amendment; 1.6. details and/ or reference to the performance study plan, such as including details of the design phase of the performance study; 1.7. if the application is a resubmission with regard to a device for which an application has been already submitted, the date or dates and reference number or numbers of the earlier application or in the case of significant amendment, reference to the original application. The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews; 1.8. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial; 1.9. identification of the Member States and third countries in which the clinical performance study is to be conducted as part of a multicentre or multinational study at the time of application; 1.10. brief description of the device for performance study, its classification and other information necessary for the identification of the device and device type; 1.11. summary of the performance study plan; 1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device; 1.13. evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical performance study in accordance with the performance study plan; 1.14. details of the anticipated start date and duration of the performance study; 1.15. details to identify the notified body, if already involved at the stage of application for the performance study; 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application; 1.17. the statement referred to in Section 4.1. 2. Investigator's brochure The investigator's brochure (IB) shall contain the information on the device for performance study that is relevant for the study and available at the time of application. Any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner. The IB shall be clearly identified and contain in particular the following information: 2.1. Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule pursuant to Annex VIII, design and manufacturing of the device and reference to previous and similar generations of the device. 2.2. Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use, including storage and handling requirements, as well as, to the extent that such information is available, information to be placed the label, and instructions for use to be provided with the device when placed on the market. In addition, information relating to any relevant training required. 2.3. Analytical performance. 2.4. Existing clinical data, in particular: \u2014 from relevant peer-reviewed scientific literature and available consensus expert opinions or positions from relevant professional associations relating to the safety, performance, clinical benefits to patients, design characteristics, scientific validity, clinical performance and intended purpose of the device and/or of equivalent or similar devices; \u2014 other relevant clinical data available relating to the safety, scientific validity, clinical performance, clinical benefits to patients, design characteristics and intended purpose of similar devices, including details of their similarities and differences with the device in question. 2.5. Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks and warnings. 2.6. In the case of devices that include tissues, cells and substances of human, animal or microbial origins detailed information on the tissues, cells and substances, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to those tissues, cells and substances. 2.7. A list detailing the fulfilment of the relevant general safety and performance requirements set out in Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or have only been partly fulfilled or are lacking. 2.8. A detailed description of the clinical procedures and diagnostic tests used in the course of the performance study and in particular information on any deviation from normal clinical practice. 3. Performance study plan as referred to in Sections 2 and 3 of Annex XIII. 4. Other information 4.1. A signed statement by the natural or legal person responsible for the manufacture of the device for performance study that the device in question conforms to the general safety and performance requirements laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject. 4.2. Where applicable according to national law, a copy of the opinion or opinions of the ethics committee or committees concerned. Where under national law the opinion or opinions of the ethics committee or committees is not required at the time of the submission of the application, a copy of the opinion or opinions shall be submitted as soon as available. 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 65 and the corresponding national law. 4.4. Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document. 4.5 Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular: \u2014 organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed; \u2014 a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects; \u2014 a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects. 4.6. Full details of the available technical documentation, for example detailed risk analysis/management documentation or specific test reports shall be submitted to the competent authority reviewing an application upon request. CHAPTER II OTHER OBLIGATIONS OF THE SPONSOR 1. The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance study, that obligation may be fulfilled by that person on behalf of the sponsor. 2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner. 3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market. Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the competent authorities for the period indicated in the first subparagraph in case the sponsor, or his contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period. 4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation. 5. The sponsor shall complete the follow-up of investigation subjects. ANNEX XV CORRELATION TABLE Directive 98/79/EC This Regulation Article 1(1) Article 1(1) Article 1(2) Article 2 Article 1(3) points (54) and (55) of Article 2 Article 1(4) \u2014 Article 1(5) Article 5(4) and (5) Article 1(6) Article 1(9) Article 1(7) Article 1(5) Article 2 Article 5(1) Article 3 Article 5(2) Article 4(1) Article 21 Article 4(2) Article 19(1) and (2) Article 4(3) Article 19(3) Article 4(4) Article 10(10) Article 4(5) Article 18(6) Article 5(1) Article 8(1) Article 5(2) \u2014 Article 5(3) Article 9 Article 6 \u2014 Article 7 Article 107 Article 8 Articles 89 and 92 Article 9(1) first subparagraph Article 48(10) first subparagraph Article 9(1) second subparagraph Article 48(3) second subparagraph, Article 48(7) second subparagraph and Article 48(9) second subparagraph Article 9(2) Article 48(3) to (6) Article 9(3) Article 48(3) to (9) Article 9(4) Article 5(6) Article 9(5) \u2014 Article 9(6) Article 11(3) and (4) Article 9(7) Article 10(7) Article 9(8) Article 49(1) Article 9(9) Article 49(4) Article 9(10) Article 51(2) Article 9(11) Article 48(12) Article 9(12) Article 54(1) Article 9(13) Article 48(2) Article 10(1) and (2), second sentence of Article 10(3) and Article 10(4) Articles 26(3), 27 and 28 Article 10(3), first sentence Article 11(1) Article 11(1) Articles 82(1) and 84(2) Article 11(2) Article 82(10) and Article 82(11) first subparagraph Article 11(3) Article 84(7) Article 11(4) \u2014 Article 11(5) Article 86 Article 12 Article 30 Article 13 Article 93 Article 14(1)(a) \u2014 Article 14(1)(b) Article 47(3) and (6) Article 14(2) \u2014 Article 14(3) \u2014 Article 15(1) Article 38 and Article 39 Article 15(2) Article 32 Article 15(3) Article 40(2) and (4) Article 15(4) \u2014 Article 15(5) Article 51(5) Article 15(6) Article 51(4) Article 15(7) Article 34(2) and Article 40(2) Article 16 Article 18 Article 17 Articles 89 to 92 Article 18 Article 94 Article 19 Article 102 Article 20 Article 97 Article 21 \u2014 Article 22 \u2014 Article 23 \u2014 Article 24 \u2014", "summary": "Ensuring the safety and performance of in vitro diagnostic medical devices Ensuring the safety and performance of in vitro diagnostic medical devices SUMMARY OF: Regulation (EU) 2017/746 on in vitro diagnostic medical devices WHAT IS THE AIM OF THE REGULATION? It updates the rules on placing on the EU market, making available and putting into service in vitro diagnostic (IVD) medical devices * for human use and their accessories. It also contains rules on the conduct of performance studies * that are carried out in the EU concerning IVD medical devices (or accessories). It aims to improve patient safety by introducing stricter procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market) and post-market surveillance. KEY POINTS Scope It covers IVD medical devices for human use and their accessories. However, devices manufactured and used in the same healthcare centre are exempted from the rules laid down by this regulation, other than the relevant general safety and performance requirements, so long as a number of conditions are fulfilled. Classification system The classification system for IVD medical devices has been adapted to the rapid scientific progress in the field and to the international guidance. They are classified according to their intended purpose and their inherent risks (classes A, B, C and D \u2014 for more details, see the regulation\u2019s Annex VIII). Notified bodies The regulation tightens the rules concerning how the independent notified bodies \u2014 which assess the conformity of medium- and high-risk medical devices before they are placed on the market \u2014 are designated, organised and monitored. These bodies have to meet the same high-quality standards throughout the EU and must have the required staff to successfully perform their conformity assessment tasks. On-site inspections of manufacturers, of which some are unannounced, must be carried out. Clinical data The regulation specifies what is required in the data collection of performance studies on IVD medical devices. These have been aligned with those applicable for clinical trials on medicinal products. These include rules on informed consent and protecting vulnerable subjects (e.g. people under the age of 18, pregnant women or the incapacitated). Performance studies conducted in more than one EU country will be subject to a coordinated assessment. Manufacturers\u2019 obligations Manufacturers have clearer and more stringent obligations to monitor the quality, performance and safety of devices. They are required to have measures in place that correspond to the level of risk, type of device and size of company. They must ensure they have sufficient financial coverage with respect to their potential liability under the product liability directive as well as quality management and post-market surveillance systems. In the event of damages due to defective devices, a manufacturer\u2019s authorised representative is jointly and severally liable. Traceability The regulation introduces a system for registering devices and manufacturers, importers and authorised representatives to ensure the traceability of devices throughout the supply chain by means of a unique device identification system. This will ensure that, should problems arise, measures can be taken rapidly. High-risk devices In the event of the first certification for class D IVD devices, and when common specifications are not available, designated reference laboratories will check the performance claimed by their manufacturers and an expert panel will be consulted on innovative devices of the same class. Although the notified body is not bound by the panel\u2019s opinion, it has to provide a justification for not following it. Nevertheless, the notified body shall not deliver this first certificate if the scientific opinion of the EU reference laboratory is negative. Genetic counselling Patients tested with a genetic test must be provided with all relevant information on its nature, significance and implications. They must be given appropriate access to counselling in cases where a test provides information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable. Incident reporting In addition to the obligation for manufacturers to report serious incidents (resulting in death or a serious deterioration in a person\u2019s health) and trends in non-serious incidents (for example, side-effects from the use of a device), the regulation introduces the obligation for EU countries to encourage and enable healthcare professionals, users and patients to report suspected incidents at national level. Market surveillance Competent EU authorities are responsible for ensuring that any unsafe device is withdrawn from the market. Eudamed A centralised database, called the European Databank on Medical Devices (Eudamed) will be developed to provide EU countries, businesses, patients, healthcare professionals and the public with information on medical devices available in the EU. Repeal of existing legislation \u2014 Directive 98/79/EC and Commission Decision 2010/227/EU The regulation repeals Directive 98/79/EC and Decision 2010/227/EU from 26 May 2022, with some exceptions laid down in Article 112. FROM WHEN DOES THE REGULATION APPLY? It entered into force on 25 May 2017 and applies from 26 May 2022. Dates of application for some of the regulation\u2019s articles vary and are detailed in Articles 110 and 113. BACKGROUND This regulation is one of 2 adopted by the EU to overhaul its laws on medical devices. The second regulation (Regulation (EU) 2017/745) concerns medical devices. For more information, see: Medical devices (European Commission).Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted:Communication from the Commission \u2014 Guidelines on COVID-19 in vitro diagnostic tests and their performance KEY TERMS In vitro diagnostic medical devices: term covering a wide variety of devices used for providing information on: (a) a physiological or pathological process or state; (b) a congenital physical or mental impairment; (c) the predisposition to a medical condition or disease; (d) the safety and compatibility between the materials used and the specimens of the body intended to be used; (e) treatment response or reactions; (f) defining or monitoring therapeutic measures. Examples range from self-tests for pregnancy through to tests for highly transmissible substances using specimens taken from the human body. Performance studies: studies that demonstrate that an IVD medical device complies with the necessary regulatory requirements through conformity assessment procedures. MAIN DOCUMENT Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, pp. 176-332) RELATED DOCUMENTS Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, pp. 1-175) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, pp. 45-48) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, pp. 1-37) Successive amendments to Directive 98/79/EC have been incorporated into the original text. This consolidated version is of documentary value only. last update 10.06.2020"}
{"article": "29.6.2016 EN Official Journal of the European Union L 171/1 REGULATION (EU) 2016/1011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The pricing of many financial instruments and financial contracts depends on the accuracy and integrity of benchmarks. Serious cases of manipulation of interest rate benchmarks such as LIBOR and EURIBOR, as well as allegations that energy, oil and foreign exchange benchmarks have been manipulated, demonstrate that benchmarks can be subject to conflicts of interest. The use of discretion, and weak governance regimes, increase the vulnerability of benchmarks to manipulation. Failures in, or doubts about, the accuracy and integrity of indices used as benchmarks can undermine market confidence, cause losses to consumers and investors and distort the real economy. It is therefore necessary to ensure the accuracy, robustness and integrity of benchmarks and of the benchmark determination process. (2) Directive 2014/65/EU of the European Parliament and of the Council (4) contains certain requirements with respect to the reliability of benchmarks used to price a listed financial instrument. Directive 2003/71/EC of the European Parliament and of the Council (5) contains certain requirements on benchmarks used by issuers. Directive 2009/65/EC of the European Parliament and of the Council (6) contains certain requirements on the use of benchmarks by undertakings for collective investment in transferable securities (UCITS). Regulation (EU) No 1227/2011 of the European Parliament and of the Council (7) contains certain provisions which prohibit the manipulation of benchmarks that are used for wholesale energy products. However, those legislative acts only cover certain aspects of certain benchmarks and they neither address all the vulnerabilities in the provision of all benchmarks, nor do they cover all uses of financial benchmarks in the financial industry. (3) Benchmarks are vital in pricing cross-border transactions, thereby facilitating the effective functioning of the internal market in a wide variety of financial instruments and services. Many benchmarks used as reference rates in financial contracts, in particular mortgages, are provided in one Member State but used by credit institutions and consumers in other Member States. In addition, such credit institutions often hedge their risks or obtain funding for granting those financial contracts in the cross-border interbank market. Only a few Member States have adopted national rules on benchmarks, but their respective legal frameworks on benchmarks already show divergences regarding aspects such as the scope of application. In addition, the International Organisation of Securities Commissions (IOSCO) agreed principles on financial benchmarks on 17 July 2013 (\u2018IOSCO principles for financial benchmarks\u2019), Principles for Oil Price Reporting Agencies on 5 October 2012 (\u2018IOSCO principles for PRAs\u2019) (together, \u2018the IOSCO principles\u2019), and since those principles provide a certain flexibility as to their exact scope and means of implementation, Member States are likely to adopt rules at national level which would implement such principles in a divergent manner. (4) Those divergent approaches would result in fragmentation of the internal market since administrators and users of benchmarks would be subject to different rules in different Member States. Thus, benchmarks provided in one Member State could be prevented from being used in other Member States. In the absence of a harmonised framework to ensure the accuracy and integrity of benchmarks used in financial instruments and financial contracts, or in order to measure the performance of investment funds, in the Union it is therefore likely that differences in Member States' laws will create obstacles to the smooth functioning of the internal market for the provision of benchmarks. (5) Union consumer protection rules do not cover the particular issue of adequate information on benchmarks in financial contracts. As a result of consumer complaints and litigation relating to the use of benchmarks in several Member States, it is likely that divergent measures, inspired by legitimate concerns of consumer protection, would be adopted at national level, which could result in fragmentation of the internal market due to the divergent conditions of competition attached to different levels of consumer protection. (6) Therefore, in order to ensure the proper functioning of the internal market and improve the conditions of its functioning, in particular with regard to financial markets, and to ensure a high level of consumer and investor protection, it is appropriate to lay down a regulatory framework for benchmarks at Union level. (7) It is appropriate and necessary for that framework to take the form of a regulation in order to ensure that provisions directly imposing obligations on persons involved in the provision, contribution and use of benchmarks are applied in a uniform manner throughout the Union. Since a legal framework for the provision of benchmarks necessarily involves measures specifying precise requirements concerning aspects inherent to such provision of benchmarks, even small divergences on the approach taken regarding one of those aspects could lead to significant impediments in the cross-border provision of benchmarks. Therefore, the use of a regulation, which is directly applicable, should reduce the possibility of divergent measures being taken at national level, and should ensure a consistent approach and greater legal certainty, and prevent the appearance of significant impediments in the cross-border provision of benchmarks. (8) The scope of this Regulation should be as broad as necessary to create a preventive regulatory framework. The provision of benchmarks involves discretion in their determination and is inherently subject to certain types of conflicts of interest, which implies the existence of opportunities and incentives to manipulate benchmarks. Such risk factors are common to all benchmarks and should be made subject to adequate governance and control requirements. The degree of risk, however, varies, and the approach adopted should therefore be tailored to the particular circumstances. Since the vulnerability and importance of a benchmark varies over time, restricting the scope by reference to indices that are currently important or vulnerable would not address the risks that any benchmark poses in the future. In particular, benchmarks that are currently not widely used could be used more in the future with the result that, in their regard, even a minor manipulation could have a significant impact. (9) The critical determinant of the scope of this Regulation should be whether the output value of the benchmark determines the value of a financial instrument or a financial contract, or measures the performance of an investment fund. Therefore, the scope should not be dependent on the nature of the input data. Benchmarks calculated from economic input data, such as share prices and non-economic numbers, or values such as weather parameters should thus be included. The framework provided for in this Regulation should also acknowledge the existence of a large number of benchmarks and the different impact that they have on financial stability and the real economy. This Regulation should also provide for a proportionate response to the risks that different benchmarks pose. This Regulation should therefore cover benchmarks which are used to price financial instruments listed or traded on regulated venues. (10) A large number of consumers are parties to financial contracts, in particular consumer credit agreements secured by mortgages, that reference benchmarks that are subject to the same risks. This Regulation should therefore cover credit agreements as defined in Directives 2008/48/EC (8) and 2014/17/EU of the European Parliament and of the Council (9). (11) Many investment indices involve significant conflicts of interest and are used to measure the performance of a fund such as a UCITS fund. Some of those benchmarks are published and others are made available, for free or upon payment of a fee, to the public or a section of the public and their manipulation can adversely affect investors. This Regulation should therefore cover indices or reference rates that are used to measure the performance of an investment fund. (12) All contributors of input data to benchmarks can exercise discretion and are potentially subject to conflicts of interest, and so risk being a source of manipulation. Contributing to a benchmark is a voluntary activity. If any initiative requires contributors to significantly change their business models, they could cease to contribute. However, for entities already subject to regulation and supervision, requiring good governance and control systems is not expected to lead to substantial costs or disproportionate administrative burden. Therefore this Regulation imposes certain obligations on supervised contributors. When a benchmark is determined on the basis of readily available data, the source of such data should not be considered to be a contributor. (13) Financial benchmarks are not only used in the issuance and manufacturing of financial instruments and contracts. The financial industry also relies on benchmarks for measuring the performance of investment funds for the purpose of return tracking or of determining the asset allocation of a portfolio or of computing the performance fees. A given benchmark can be used either directly as a reference for financial instruments and financial contracts or to measure the performance of investment funds, or indirectly within a combination of benchmarks. In the latter case, the setting and review of the weights to be assigned to various indices within a combination for the purpose of determining the pay-out or the value of a financial instrument or a financial contract or measuring the performance of an investment fund also amounts to use as such an activity does not involve discretion, in contrast to the activity of provision of benchmarks. The holding of financial instruments referencing a certain benchmark is not considered to be use of the benchmark. (14) Central banks already meet principles, standards and procedures which ensure that they exercise their activities with integrity and in an independent manner. It is therefore not necessary that central banks be subject to this Regulation. When central banks provide benchmarks, especially where those benchmarks are intended for transaction purposes, it is their responsibility to set appropriate internal procedures in order to ensure the accuracy, integrity, reliability and independence of those benchmarks, in particular with respect to transparency in governance and computation methodology. (15) Furthermore, public authorities, including national statistics agencies, should not be subject to this Regulation where they contribute data to, provide or have control over the provision of, benchmarks for public policy purposes, including measures of employment, economic activity, and inflation. (16) An administrator is the natural or legal person that has control over the provision of a benchmark and in particular administers the arrangements for determining the benchmark, collects and analyses the input data, determines the benchmark and publishes it. An administrator should be able to outsource to a third party one or more of those functions, including the calculation or publication of the benchmark, or other relevant services and activities in the provision of the benchmark. However, where a person merely publishes or refers to a benchmark as part of that person's journalistic activities but does not have control over the provision of that benchmark, that person should not be subject to the requirements imposed on administrators by this Regulation. (17) An index is calculated using a formula or some other methodology on the basis of underlying values. There exists a degree of discretion in constructing the formula, performing the necessary calculation and determining the input data which creates a risk of manipulation. Therefore, all benchmarks sharing that characteristic of discretion should be covered by this Regulation. (18) However, where a single price or value is used as a reference to a financial instrument, for example where the price of a single security is the reference price for an option or future, there is no calculation, input data or discretion. Therefore single price or single value reference prices should not be considered to be benchmarks for the purposes of this Regulation. (19) Reference prices or settlement prices produced by central counterparties (CCPs) should not be considered to be benchmarks because they are used to determine settlement, margins and risk management and thus do not determine the amount payable under a financial instrument or the value of a financial instrument. (20) The provision of borrowing rates by creditors should not be considered to be benchmark provision for the purposes of this Regulation. A borrowing rate provided by a creditor is either set by an internal decision or calculated as a spread or mark-up over an index (e.g. EURIBOR). In the first case, the creditor is exempt from this Regulation for activity concerning financial contracts entered into by that creditor with its own clients, while in the latter case the creditor is considered to be only a user of a benchmark. (21) In order to ensure the integrity of benchmarks, benchmark administrators should be required to implement adequate governance arrangements to control conflicts of interest and to safeguard confidence in the integrity of benchmarks. Even where effectively managed, most administrators are subject to some conflicts of interest and could have to make judgements and decisions which affect a diverse group of stakeholders. It is therefore important that administrators have in place a function that operates with integrity to oversee the implementation and effectiveness of the governance arrangements that provide effective oversight. (22) The manipulation or unreliability of benchmarks can cause damage to investors and consumers. Therefore, this Regulation should set out a framework for retention of records by administrators and contributors as well as for providing transparency about a benchmark's purpose and methodology which facilitates a more efficient and fairer resolution of potential claims in accordance with national or Union law. (23) Auditing and the effective enforcement of this Regulation requires ex post analysis and evidence. This Regulation should therefore set out requirements for adequate record-keeping by benchmark administrators relating to the calculation of the benchmark for a sufficient period of time. The reality that a benchmark intends to measure and the environment in which it is measured are likely to change over time. Therefore it is necessary that the process and methodology of the provision of benchmarks are reviewed on a periodic basis to identify shortcomings and possible improvements. Many stakeholders can be impacted by failures in the provision of the benchmark and can help identify such shortcomings. This Regulation should therefore set out a framework for the establishment of a complaints handling mechanism by benchmark administrators to enable stakeholders to notify the benchmark administrator of complaints and ensure that the benchmark administrator objectively evaluates the merits of any complaint. (24) The provision of benchmarks frequently involves the outsourcing of important functions such as calculating the benchmark, gathering input data and disseminating the benchmark. In order to ensure the effectiveness of the governance arrangements, it is necessary to ensure that any such outsourcing does not relieve benchmark administrators of any of their obligations and responsibilities, and is done in such a way that it does not interfere with either the administrators' ability to meet their obligations or responsibilities, or the relevant competent authority's ability to supervise them. (25) The benchmark administrator is the central recipient of input data and is able to evaluate the integrity and accuracy of input data on a consistent basis. It is therefore necessary that this Regulation requires administrators to take certain measures where an administrator considers that input data does not represent the market or economic reality that a benchmark intends to measure, comprising measures to change the input data, the contributors or the methodology or else to cease providing that benchmark. Furthermore, an administrator should, as part of its control framework, establish measures to monitor, where feasible, input data prior to the publication of the benchmark and to validate input data after publication, including comparing that data against historical patterns where applicable. (26) Any discretion that can be exercised in providing input data creates an opportunity to manipulate a benchmark. Where the input data is transaction-based data, there is less discretion and therefore the opportunity to manipulate the data is reduced. As a general rule, benchmark administrators should therefore use actual transaction-based input data where possible but other data can be used in those cases where the transaction data is insufficient or inappropriate to ensure the integrity and accuracy of the benchmark. (27) The accuracy and reliability of a benchmark in measuring the economic reality it is intended to measure depends on the methodology and input data used. It is therefore necessary to adopt a transparent methodology that ensures the benchmark's reliability and accuracy. Such transparency does not mean the publication of the formula applied for the determination of a given benchmark, but rather the disclosure of elements sufficient to allow stakeholders to understand how the benchmark is derived and to assess its representativeness, relevance and appropriateness for its intended use. (28) It could become necessary to change the methodology to ensure the continued accuracy of the benchmark, but any changes in the methodology have an impact on users and stakeholders of the benchmark. It is therefore necessary to specify the procedures to be followed when changing the benchmark methodology, including the need for consultation, so that users and stakeholders can take the necessary action in light of those changes or notify the administrator if they have concerns about those changes. (29) Employees of the administrator can identify possible infringements of this Regulation or potential vulnerabilities that could lead to manipulation or attempted manipulation. This Regulation should therefore put in place a framework to enable employees to alert administrators confidentially of possible infringements of this Regulation. (30) The integrity and accuracy of benchmarks depends on the integrity and accuracy of the input data provided by contributors. It is essential that the obligations of contributors in respect of such input data are clearly specified, that compliance with those obligations can be relied upon, and that the obligations are consistent with the benchmark administrator's controls and methodology. It is therefore necessary that the benchmark administrator produces a code of conduct to specify those requirements and the contributor's responsibilities concerning the provision of input data. The administrator should be satisfied that contributors adhere to the code of conduct. Where contributors are located in third countries, the administrator should be satisfied to the extent possible. (31) Contributors are potentially subject to conflicts of interest and are able to exercise discretion in the determination of input data. Therefore, it is necessary for contributors to be subject to governance arrangements in order to ensure that those conflicts are managed and that the input data is accurate, conforms to the administrator's requirements and can be validated. (32) Many benchmarks are determined by the application of a formula using input data that is provided by the following entities: a trading venue, an approved publication arrangement, a consolidated tape provider, an approved reporting mechanism, an energy exchange or an emission allowance auction platform. In some situations, data collection is outsourced to a service provider that receives the data entirely and directly from those entities. In those cases, existing regulation and supervision ensure the integrity and transparency of the input data and provide for governance requirements and procedures for the notification of infringements. Therefore, those benchmarks are less vulnerable to manipulation, are subject to independent verifications, and the relevant administrators are accordingly released from certain obligations set out in this Regulation. (33) Different types of benchmarks and different benchmark sectors have different characteristics, vulnerabilities and risks. The provisions of this Regulation should be further specified for particular benchmark sectors and types. Interest rate benchmarks are benchmarks that play an important role in the transmission of monetary policy and so it is necessary to introduce specific provisions in this Regulation for such benchmarks. (34) Physical commodities markets have unique characteristics which should be taken into account. Commodity benchmarks are widely used and can have sector-specific characteristics, so it is necessary to introduce specific provisions in this Regulation for such benchmarks. Certain commodity benchmarks are exempt from this Regulation but would need to nevertheless respect the relevant IOSCO principles. Commodity benchmarks can become critical since the regime is not limited to benchmarks based on submissions by contributors which are in majority supervised entities. For critical commodity benchmarks subject to Annex II, the requirements of this Regulation regarding mandatory contribution and colleges are not applicable. (35) The failure of critical benchmarks can impact market integrity, financial stability, consumers, the real economy, or the financing of households and businesses in Member States. Those potentially destabilising effects of the failure of a critical benchmark could be felt in a single Member State or in more than one. It is therefore necessary that this Regulation provides for a process to determine those benchmarks that should be considered to be critical benchmarks and that additional requirements apply to ensure the integrity and robustness of such benchmarks. (36) Critical benchmarks can be determined using a quantitative criterion or a combination of quantitative and qualitative criteria. In addition, in cases where a benchmark does not meet the appropriate quantitative threshold, it could nonetheless be recognised as critical where the benchmark has no or very few market-led substitutes and its existence and accuracy are relevant for market integrity, financial stability or consumer protection in one or more Member States, and where all the relevant competent authorities agree that such a benchmark should be recognised as critical. In the event of disagreement between the relevant competent authorities, the decision of the competent authority of the administrator on whether such a benchmark should be recognised as critical should prevail. In such a case, the European Securities and Markets Authority (ESMA), established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (10), should be able to publish an opinion on the assessment made by the competent authority of the administrator. Furthermore, a competent authority can also designate a benchmark as critical based on certain qualitative criteria where the administrator and the majority of the contributors to the benchmark are located in its Member State. All critical benchmarks should be included in a list established by a way of an implementing act by the Commission, which should be reviewed and updated regularly. (37) The cessation of the administration of a critical benchmark by an administrator could render financial contracts or financial instruments invalid, cause losses to consumers and investors, and impact financial stability. It is therefore necessary to include a power for the relevant competent authority to require mandatory administration of a critical benchmark in order to preserve the existence of the benchmark in question. In the event of insolvency proceedings of a benchmark administrator, the competent authority should provide an assessment for the consideration of the relevant judicial authority of whether and how the critical benchmark could be transitioned to a new administrator or could cease to be provided. (38) Without prejudice to the application of Union competition law and the ability of Member States to take measures to facilitate compliance with it, it is necessary to require administrators of critical benchmarks, including critical commodity benchmarks, to take adequate steps to ensure that licences of, and information on, benchmarks are provided on a fair, reasonable, transparent and non-discriminatory basis to all users. (39) Contributors that cease to contribute input data to critical benchmarks can undermine the credibility of such benchmarks, as the capability of such benchmarks to measure the underlying market or economic reality would as a result be impaired. It is therefore necessary to include a power for the relevant competent authority to require mandatory contributions from supervised entities to critical benchmarks in order to preserve the credibility of the benchmark in question. Mandatory contribution of input data is not intended to impose an obligation on supervised entities to enter into, or to commit to entering into, transactions. (40) Due to the existence of a large variety of types and sizes of benchmarks, it is important to introduce proportionality in this Regulation and to avoid putting an excessive administrative burden on administrators of benchmarks the cessation of which poses less threat to the wider financial system. Thus, in addition to the regime for critical benchmarks, two distinct regimes should be introduced: one for significant benchmarks and one for non-significant benchmarks. (41) Administrators of significant benchmarks should be able to choose not to apply a limited number of detailed requirements of this Regulation. Competent authorities should, however, maintain the right to require the application of those requirements, based on criteria outlined in this Regulation. Delegated acts and implementing acts that apply to significant benchmark administrators should take due account of the principle of proportionality and aim to avoid administrative burden where possible. (42) Administrators of non-significant benchmarks are subject to a less detailed regime, whereby administrators should be able to choose not to apply some requirements of this Regulation. In such a case, the administrator in question should explain why it is appropriate not to do so in a compliance statement which should be published and provided to the administrator's competent authority. That competent authority should review the compliance statement and should be able to request additional information or require changes to ensure compliance with this Regulation. While non-significant benchmarks could still be vulnerable to manipulation, they are more easily substitutable, therefore transparency to users should be the main tool used for market participants to make informed choices about the benchmarks they consider appropriate for use. For that reason, the delegated acts in Title II should not apply to non-significant benchmark administrators. (43) In order for users of benchmarks to choose appropriately from among, and understand the risks of, benchmarks, they need to know what a given benchmark intends to measure and its susceptibility to manipulation. Therefore, the benchmark administrator should publish a benchmark statement specifying those elements. In order to ensure uniform application and that benchmark statements are of reasonable length but at the same time focus on providing the key information needed to users in an easily accessible manner, ESMA should provide further specification of the content of the benchmark statement, differentiating appropriately among the different types and specificities of benchmarks and their administrators. (44) This Regulation should take into account the IOSCO principles, which serve as global standards for regulatory requirements for benchmarks. As an overarching principle, in order to ensure investor protection, supervision and regulation in a third country should be equivalent to Union supervision and regulation of benchmarks. Therefore, benchmarks provided from that third country can be used by supervised entities in the Union where a positive decision on equivalence of the third- country regime has been taken by the Commission. In such circumstances, competent authorities should enter into cooperation arrangements with supervisory authorities in third countries. ESMA should coordinate the development of such cooperation arrangements and the exchange between competent authorities of information received from third countries. However, in order to avoid any adverse impact resulting from a possible abrupt cessation of the use in the Union of benchmarks provided from a third country, this Regulation also provides for certain other mechanisms (namely, recognition and endorsement) under which third-country benchmarks can be used by supervised entities located in the Union. (45) This Regulation introduces a process for the recognition of administrators located in a third country by the competent authority of the Member State of reference. Recognition should be granted to administrators complying with the requirements of this Regulation. Acknowledging the role of the IOSCO principles as a global standard for the provision of benchmarks, the competent authority of the Member State of reference should be able to grant recognition to administrators on the basis of them applying the IOSCO principles. To do so, the competent authority should assess the application of the IOSCO principles by a specific administrator and determine whether such application is equivalent, for the administrator in question, to compliance with the various requirements established in this Regulation, taking into account the specificities of the regime of recognition as compared to the equivalence regime. (46) This Regulation also introduces an endorsement regime allowing, under certain conditions, administrators or supervised entities located in the Union to endorse benchmarks provided from a third country in order for such benchmarks to be used in the Union. To do so, the competent authority should take into account whether, in providing the benchmark to be endorsed, compliance with the IOSCO principles would be equivalent to compliance with this Regulation, taking into account the specificities of the regime of endorsement as compared to the equivalence regime. An administrator or a supervised entity that has endorsed a benchmark provided from a third country should be fully responsible for such endorsed benchmarks and for the fulfilment of the relevant conditions referred to in this Regulation. (47) All benchmark administrators are able to exercise discretion, are potentially subject to conflicts of interest, and risk having inadequate governance and control systems in place. As administrators control the benchmark determination process, requiring authorisation or registration and supervision of administrators is the most effective way of ensuring the integrity of benchmarks. (48) Certain administrators should be authorised and supervised by the competent authority of the Member State where the administrator in question is located. Entities already subject to supervision and that provide financial benchmarks other than critical benchmarks should be registered and supervised by the competent authority for the purposes of this Regulation. Entities that provide only indices that qualify as non-significant benchmarks should also be registered by the relevant competent authority. Authorisation and registration should be distinct processes with authorisation requiring a more extensive assessment of the administrator's application. Whether an administrator is authorised or registered should not affect the supervision of that administrator by the relevant competent authorities. Additionally, a transitional regime should be introduced, according to which persons providing benchmarks which are not critical and are not widely used in one or more Member States could be registered, with a view to facilitating the initial phase of application of this Regulation. ESMA should maintain at the Union level a register that contains information on authorised or registered administrators, on benchmarks and the administrators that provide those benchmarks by virtue of a positive decision under either the equivalence regime or the recognition regime, on Union administrators or supervised entities that have endorsed benchmarks from a third country, and on any such endorsed benchmarks and their administrators located in a third country. (49) In some circumstances a person provides an index but could be unaware that the index in question is being used as a reference for a financial instrument, a financial contract or an investment fund. That is particularly the case where the users and benchmark administrator are located in different Member States. It is therefore necessary to increase the level of transparency concerning which specific benchmark is being used. Such transparency can be achieved by improving the content of the prospectuses or key information documents required by Union law and the content of the notifications required by Regulation (EU) No 596/2014 of the European Parliament and of the Council (11). (50) A set of effective tools and powers and resources for the competent authorities of Member States guarantees supervisory effectiveness. This Regulation should therefore, in particular, provide for a minimum set of supervisory and investigative powers which should be entrusted to competent authorities of Member States in accordance with national law. When exercising their powers under this Regulation, competent authorities and ESMA should act objectively and impartially and remain autonomous in their decision-making. (51) For the purpose of detecting infringements of this Regulation, it is necessary for competent authorities to be able to access, in accordance with national law, the premises of legal persons in order to seize documents. Access to such premises is necessary when there is reasonable suspicion that documents and other data related to the subject-matter of an inspection or investigation exist and could be relevant to prove an infringement of this Regulation. Additionally, access to such premises is necessary where the person to whom a demand for information has already been made fails to comply with it, or where there are reasonable grounds for believing that if a demand were to be made, it would not be complied with, or that the documents or information to which the information requirement relates would be removed, tampered with or destroyed. If prior authorisation is needed from the judicial authority of the Member State concerned, in accordance with national law, access to premises should take place after having obtained that prior judicial authorisation. (52) Existing recordings of telephone conversations and data traffic records from supervised entities can constitute crucial, and sometimes the only, evidence to detect and prove the existence of infringements of this Regulation, in particular the compliance with governance and control requirements. Such records and recordings can help to verify the identity of the person responsible for the submission of input data, those responsible for its approval and whether organisational separation of employees is maintained. Therefore, competent authorities should be able to require existing recordings of telephone conversations, electronic communications and data traffic records held by supervised entities, in those cases where a reasonable suspicion exists that such recordings or records related to the subject-matter of the inspection or investigation could be relevant to prove an infringement of this Regulation. (53) This Regulation respects the fundamental rights and observes the principles recognised in the Treaty on the Functioning of the European Union (TFEU) and in the Charter of Fundamental Rights of the European Union, in particular the right to respect for private and family life, the protection of personal data, the right to freedom of expression and information, the freedom to conduct a business, the right to property, the right to consumer protection, the right to an effective remedy, the right of defence. Accordingly, this Regulation should be interpreted and applied in accordance with those rights and principles. (54) The rights of defence of the persons concerned should be fully respected. In particular, persons subject to proceedings should be provided with access to the findings upon which the competent authorities has based the decision and should be given the right to be heard. (55) Transparency regarding benchmarks is necessary for reasons of financial market stability and investor protection. Any exchange or transmission of information by competent authorities should take place in accordance with the rules on the transfer of personal data laid down in Directive 95/46/EC of the European Parliament and of the Council (12). Any exchange or transmission of information by ESMA should take place in accordance with the rules on the transfer of personal data laid down in Regulation (EC) No 45/2001 of the European Parliament and of the Council (13). (56) Taking into consideration the principles set out in the Commission's Communication of 8 December 2010 on reinforcing sanctioning regimes in the financial services sector, and legal acts of the Union adopted as a follow-up to that Communication, Member States should, in order to ensure a common approach and deterrent effect, lay down rules on administrative sanctions and other administrative measures, including pecuniary sanctions, applicable to infringements of the provisions of this Regulation and should ensure that they are implemented. Those administrative sanctions and other administrative measures should be effective, proportionate and dissuasive. (57) Administrative sanctions and other administrative measures applied in specific cases should be determined taking into account, where appropriate, factors such as the repayment of any identified financial benefit, the gravity and duration of the infringement, any aggravating or mitigating factors, the need for administrative pecuniary sanctions to have a deterrent effect and, where appropriate, include a reduction in return for cooperation with the competent authority. In particular, the actual amount of administrative pecuniary sanctions to be imposed in a specific case should be able to reach the maximum level provided for in this Regulation, or the higher level provided for in national law, for very serious infringements, while administrative pecuniary sanctions significantly lower than the maximum level should be able to be applied to minor infringements or in case of settlement. The possibility of imposing a temporary ban on the exercise of management functions within benchmark administrators or contributors should be available to the competent authority. (58) This Regulation should not limit the ability of Member States to provide for higher levels of administrative sanctions and should be without prejudice to any provisions in the law of Member States relating to criminal sanctions. (59) Even though nothing prevents Member States from laying down rules for administrative and criminal sanctions for the same infringement, Member States should not be required to lay down rules for administrative sanctions for the infringements of this Regulation which are subject to national criminal law. In accordance with national law, Member States are not obliged to impose both administrative and criminal sanctions for the same offence, but they should be able to do so if their national law so permits. However, the maintenance of criminal sanctions instead of administrative sanctions for infringements of this Regulation should not reduce or otherwise affect the ability of competent authorities to cooperate, access and exchange information in a timely way with competent authorities in other Member States for the purposes of this Regulation, including after any referral of the relevant infringements to the competent judicial authorities for criminal prosecution. (60) It is necessary to reinforce provisions on exchange of information between competent authorities and to strengthen the duties of assistance and cooperation which they owe to each other. Due to increasing cross-border activity, competent authorities should provide each other with the relevant information for the exercise of their function, so as to ensure the effective enforcement of this Regulation, including in situations where an infringement or suspected infringement is of concern to authorities in two or more Member States. When exchanging information, strict professional secrecy is needed to ensure the smooth transmission of that information and the protection of particular rights. (61) In order to ensure that decisions made by competent authorities to impose an administrative sanction or other administrative measure have a deterrent effect on the public at large, they should be published. The publication of decisions imposing an administrative sanction or other administrative measure is also an important tool for competent authorities to inform market participants of the type of behaviour that is considered to infringe this Regulation and to promote wider good behaviour amongst market participants. If such publication risks causing disproportionate damage to the persons involved, or jeopardises the stability of financial markets or an on-going investigation, the competent authority should either publish the administrative sanction or other administrative measure on an anonymous basis or delay the publication. In addition, competent authorities should have the option not to publish a decision imposing administrative sanctions or other administrative measures at all where anonymous or delayed publication is considered insufficient to ensure that the stability of financial markets is not jeopardised. Competent authorities are also not required to publish administrative sanctions or other administrative measures which are deemed to be of a minor nature where publication would be disproportionate. (62) Critical benchmarks can involve contributors, administrators and users in more than one Member State. Thus, the cessation of the provision of such a benchmark or any events that can significantly undermine its integrity could have an impact in more than one Member State, meaning that the supervision of such a benchmark only by the competent authority of the Member State in which the administrator of the benchmark is located will not be efficient and effective in terms of addressing the risks that the critical benchmark poses. In such a case, in order to ensure the effective exchange of supervisory information among competent authorities and coordination of their activities and supervisory measures, colleges, comprising competent authorities and ESMA, should be formed. The activities of the colleges should contribute to the harmonised application of rules under this Regulation and to the convergence of supervisory practices. The competent authority of the administrator should establish written arrangements regarding the exchange of information, the decision-making process, which could include rules on voting procedures, any cooperation for the purposes of mandatory contribution measures, and the cases where the competent authorities should consult each other. ESMA's legally binding mediation is a key element of the achievement of coordination, supervisory consistency and convergence of supervisory practices. (63) Benchmarks can reference financial instruments and financial contracts that have a long duration. In certain cases, such benchmarks risk no longer being permitted to be provided once this Regulation comes into effect because they have characteristics that cannot be adjusted to conform to the requirements of this Regulation. At the same time, prohibiting the continued provision of such a benchmark could result in the termination or frustration of the financial instruments or financial contracts and so harm investors. It is therefore necessary to make provision to allow for the continued provision of such benchmarks for a transitional period. (64) In cases where this Regulation captures or potentially captures supervised entities and markets covered by Regulation (EU) No 1227/2011, the Agency for the Cooperation of Energy Regulators (ACER) would need to be consulted by ESMA in order to draw upon ACER's expertise in energy markets and to mitigate any dual regulation. (65) In order to specify further technical elements of this Regulation, the power to adopt acts in accordance with Article 290 of TFEU should be delegated to the Commission in respect of the specification of technical elements of definitions; in respect of the calculation of the nominal amounts of financial instruments, notional amount of derivatives and the net asset value of investment funds referencing a benchmark to determine whether such benchmark is critical; in respect of reviewing the calculation method used to determine the threshold for the determination of critical and significant benchmarks; in respect of establishing the objective reasons for the endorsement of a benchmark or family of benchmarks provided in a third country; in respect of establishing the elements to assess whether the cessation or the changing of an existing benchmark could reasonably result in a force majeure event, frustrate or otherwise breach the terms of any financial contract or financial instrument, or the rules of any investment fund, which references such benchmark; and in respect of the extension of the 24-month period envisaged for the registration instead of authorisation of certain administrators. When adopting those acts, the Commission should take into account the market or technological developments and the international convergence of supervisory practice in relation to benchmarks, in particular the work of IOSCO. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (14) of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (66) Technical standards should ensure consistent harmonisation of the requirements for the provision of and contribution to indices used as benchmarks and adequate protection of investors and consumers across the Union. As a body with highly specialised expertise, it would be efficient and appropriate to entrust ESMA with the elaboration of draft regulatory technical standards which do not involve policy choices for submission to the Commission. The Commission should adopt draft regulatory technical standards developed by ESMA by means of delegated acts pursuant to Article 290 TFEU and in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010, regarding the procedures and the characteristics of the oversight function; regarding how to ensure the appropriateness and the verifiability of the input data as well as the internal oversight and verification procedures of a contributor; regarding the information to be provided by an administrator about the benchmark and methodology; regarding the elements of the code of conduct; regarding the requirements concerning systems and controls; regarding the criteria that the competent authority should take into account when deciding whether to apply certain additional requirements; regarding the contents of the benchmark statement and the cases in which an update of such a statement is required; regarding the minimum content of the cooperation arrangements between the competent authorities and ESMA; regarding the form and content of the application for recognition of a third country administrator and presentation of the information that is to be provided with such an application; and regarding the information to be provided in the application for authorisation or registration. (67) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish and review a list of public authorities in the Union, to establish and review the list of critical benchmarks, and to determine the equivalence of the legal framework to which providers of benchmarks of third countries are subject for the purposes of full or partial equivalence. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (15). (68) The Commission should also be empowered to adopt implementing technical standards developed by ESMA establishing templates for the compliance statements, procedures and forms for exchange of information between competent authorities and ESMA, by means of implementing acts pursuant to Article 291 TFEU and in accordance with Article 15 of Regulation (EU) No 1095/2010. (69) Since the objectives of this Regulation, namely to lay down a consistent and effective regime to address the vulnerabilities that benchmarks pose, cannot be sufficiently achieved by the Member States, given that the overall impact of the problems relating to benchmarks can be fully perceived only in a Union context, but can rather, by reason of the scale and effects of this Regulation, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (70) Given the urgency of the need to restore confidence in benchmarks and promote fair and transparent financial markets, this Regulation should enter into force on the day following that of its publication. (71) Consumers are able to enter into financial contracts, in particular mortgages and consumer credit contracts, that reference a benchmark, but unequal bargaining power and the use of standard terms mean that they can have a limited choice about the benchmark used. It is therefore necessary to ensure that at least adequate information is provided by creditors or credit intermediaries to consumers. To that end, Directives 2008/48/EC and 2014/17/EU should therefore be amended accordingly. (72) Regulation (EU) No 596/2014 requires persons discharging managerial responsibilities, as well as persons closely associated with them, to notify the issuer and the competent authority of every transaction conducted on their own account relating to financial instruments that are themselves linked to shares and debt instruments of their issuer. However, there are a variety of financial instruments that are linked to shares and debt instruments of a given issuer. Such financial instruments include units in collective investment undertakings, structured products or financial instruments embedding a derivative that provides exposure to the performance of shares or debt instruments issued by an issuer. Every transaction in such financial instruments above a de minimis threshold should be subject to notification to the issuer and the competent authority. An exception should be made where either the linked financial instrument provides an exposure of 20 % or less to the issuer's shares or debt instruments, or the person discharging managerial responsibilities or person closely associated with them did not and could not know the investment composition of the linked financial instrument. Regulation (EU) No 596/2014 should therefore be amended, HAVE ADOPTED THIS REGULATION: TITLE I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject-matter This Regulation introduces a common framework to ensure the accuracy and integrity of indices used as benchmarks in financial instruments and financial contracts, or to measure the performance of investment funds in the Union. This Regulation thereby contributes to the proper functioning of the internal market while achieving a high level of consumer and investor protection. Article 2 Scope 1. This Regulation applies to the provision of benchmarks, the contribution of input data to a benchmark and the use of a benchmark within the Union. 2. This Regulation shall not apply to: (a) a central bank; (b) a public authority, where it contributes data to, provides, or has control over the provision of, benchmarks for public policy purposes, including measures of employment, economic activity, and inflation; (c) a central counterparty (CCP), where it provides reference prices or settlement prices used for CCP risk-management purposes and settlement; (d) the provision of a single reference price for any financial instrument listed in Section C of Annex I to Directive 2014/65/EU; (e) the press, other media and journalists where they merely publish or refer to a benchmark as part of their journalistic activities with no control over the provision of that benchmark; (f) a natural or legal person that grants or promises to grant credit in the course of that person's trade, business or profession, only insofar as that person publishes or makes available to the public that person's own variable or fixed borrowing rates set by internal decisions and applicable only to financial contracts entered into by that person or by a company within the same group with their respective clients; (g) a commodity benchmark based on submissions from contributors the majority of which are non-supervised entities and in respect of which both of the following conditions apply: (i) the benchmark is referenced by financial instruments for which a request for admission to trading has been made on only one trading venue, as defined in point (24) of Article 4(1) of Directive 2014/65/EU, or which are traded on only one such trading venue; (ii) the total notional value of financial instruments referencing the benchmark does not exceed EUR 100 million; (h) an index provider in respect of an index provided by said provider where that index provider is unaware and could not reasonably have been aware that that index is used for the purposes referred to in point (3) of Article 3(1). Article 3 Definitions 1. For the purposes of this Regulation, the following definitions apply: (1) \u2018index\u2019 means any figure: (a) that is published or made available to the public; (b) that is regularly determined: (i) entirely or partially by the application of a formula or any other method of calculation, or by an assessment; and (ii) on the basis of the value of one or more underlying assets or prices, including estimated prices, actual or estimated interest rates, quotes and committed quotes, or other values or surveys; (2) \u2018index provider\u2019 means a natural or legal person that has control over the provision of an index; (3) \u2018benchmark\u2019 means any index by reference to which the amount payable under a financial instrument or a financial contract, or the value of a financial instrument, is determined, or an index that is used to measure the performance of an investment fund with the purpose of tracking the return of such index or of defining the asset allocation of a portfolio or of computing the performance fees; (4) \u2018family of benchmarks\u2019 means a group of benchmarks provided by the same administrator and determined from input data of the same nature which provides specific measures of the same or similar market or economic reality; (5) \u2018provision of a benchmark\u2019 means: (a) administering the arrangements for determining a benchmark; (b) collecting, analysing or processing input data for the purpose of determining a benchmark; and (c) determining a benchmark through the application of a formula or other method of calculation or by an assessment of input data provided for that purpose; (6) \u2018administrator\u2019 means a natural or legal person that has control over the provision of a benchmark; (7) \u2018use of a benchmark\u2019 means: (a) issuance of a financial instrument which references an index or a combination of indices; (b) determination of the amount payable under a financial instrument or a financial contract by referencing an index or a combination of indices; (c) being a party to a financial contract which references an index or a combination of indices; (d) providing a borrowing rate as defined in point (j) of Article 3 of Directive 2008/48/EC calculated as a spread or mark-up over an index or a combination of indices and that is solely used as a reference in a financial contract to which the creditor is a party; (e) measuring the performance of an investment fund through an index or a combination of indices for the purpose of tracking the return of such index or combination of indices, of defining the asset allocation of a portfolio, or of computing the performance fees; (8) \u2018contribution of input data\u2019 means providing any input data not readily available to an administrator, or to another person for the purposes of passing to an administrator, that is required in connection with the determination of a benchmark, and is provided for that purpose; (9) \u2018contributor\u2019 means a natural or legal person contributing input data; (10) \u2018supervised contributor\u2019 means a supervised entity that contributes input data to an administrator located in the Union; (11) \u2018submitter\u2019 means a natural person employed by the contributor for the purpose of contributing input data; (12) \u2018assessor\u2019 means an employee of an administrator of a commodity benchmark, or any other natural person whose services are placed at the administrator's disposal or under the control of the administrator, and who is responsible for applying a methodology or judgement to input data and other information to reach a conclusive assessment about the price of a certain commodity; (13) \u2018expert judgement\u2019 means the exercise of discretion by an administrator or a contributor with respect to the use of data in determining a benchmark, including extrapolating values from prior or related transactions, adjusting values for factors that might influence the quality of data such as market events or impairment of a buyer or seller's credit quality, and weighting firm bids or offers greater than a particular concluded transaction; (14) \u2018input data\u2019 means the data in respect of the value of one or more underlying assets, or prices, including estimated prices, quotes, committed quotes or other values, used by an administrator to determine a benchmark; (15) \u2018transaction data\u2019 means observable prices, rates, indices or values representing transactions between unaffiliated counterparties in an active market subject to competitive supply and demand forces; (16) \u2018financial instrument\u2019 means any of the instruments listed in Section C of Annex I to Directive 2014/65/EU for which a request for admission to trading on a trading venue, as defined in point (24) of Article 4(1) of Directive 2014/65/EU, has been made or which is traded on a trading venue as defined in point (24) of Article 4(1) of Directive 2014/65/EU or via a systematic internaliser as defined in point (20) of Article 4(1) of that Directive; (17) \u2018supervised entity\u2019 means any of the following: (a) a credit institution as defined in point (1) of Article 4(1) of Regulation (EU) No 575/2013 of the European Parliament and of the Council (16); (b) an investment firm as defined in point (1) of Article 4(1) of Directive 2014/65/EU; (c) an insurance undertaking as defined in point (1) of Article 13 of Directive 2009/138/EC of the European Parliament and of the Council (17); (d) a reinsurance undertaking as defined in point (4) of Article 13 of Directive 2009/138/EC; (e) a UCITS as defined in Article 1(2) of Directive 2009/65/EC or, where applicable, a UCITS management company as defined in point (b) of Article 2(1) of that Directive; (f) an alternative investment fund manager (AIFM) as defined in point (b) of Article 4(1) of Directive 2011/61/EU of the European Parliament and of the Council (18); (g) an institution for occupational retirement provision as defined in point (a) of Article 6 of Directive 2003/41/EC of the European Parliament and of the Council (19); (h) a creditor as defined in point (b) of Article 3 of Directive 2008/48/EC for the purposes of credit agreements as defined in point (c) of Article 3 of that Directive; (i) a non-credit institution as defined in point (10) of Article 4 of Directive 2014/17/EU for the purposes of credit agreements as defined in point (3) of Article 4 of that Directive; (j) a market operator as defined in point (18) of Article 4(1) of Directive 2014/65/EU; (k) a CCP as defined in point (1) of Article 2 of Regulation (EU) No 648/2012 of the European Parliament and of the Council (20); (l) a trade repository as defined in point (2) of Article 2 of Regulation (EU) No 648/2012; (m) an administrator; (18) \u2018financial contract\u2019 means: (a) any credit agreement as defined in point (c) of Article 3 of Directive 2008/48/EC; (b) any credit agreement as defined in point (3) of Article 4 of Directive 2014/17/EU; (19) \u2018investment fund\u2019 means an AIF as defined in point (a) of Article 4(1) of Directive 2011/61/EU, or a UCITS as defined in Article 1(2) of Directive 2009/65/EC; (20) \u2018management body\u2019 means the body or bodies of an administrator or another supervised entity which are appointed in accordance with national law, which are empowered to set the strategy, objectives and overall direction of the administrator or other supervised entity, and which oversee and monitor management decision-making and include persons who effectively direct the business of the administrator or other supervised entity; (21) \u2018consumer\u2019 means a natural person who, in financial contracts covered by this Regulation, is acting for purposes which are outside his or her trade, business or profession; (22) \u2018interest rate benchmark\u2019 means a benchmark which for the purposes of point (1)(b)(ii) of this paragraph is determined on the basis of the rate at which banks may lend to, or borrow from, other banks, or agents other than banks, in the money market; (23) \u2018commodity benchmark\u2019 means a benchmark where the underlying asset for the purposes of point (1)(b)(ii) of this paragraph is a commodity within the meaning of point (1) of Article 2 of Commission Regulation (EC) No 1287/2006 (21), excluding emission allowances as referred to in point (11) of Section C of Annex I to Directive 2014/65/EU; (24) \u2018regulated-data benchmark\u2019 means a benchmark determined by the application of a formula from: (a) input data contributed entirely and directly from: (i) a trading venue as defined in point (24) of Article 4(1) of Directive 2014/65/EU or a trading venue in a third country for which the Commission has adopted an implementing decision that the legal and supervisory framework of that country is considered to have equivalent effect within the meaning of Article 28(4) of Regulation (EU) No 600/2014 of the European Parliament and of the Council (22), or a regulated market considered to be equivalent under Article 2a of Regulation (EU) No 648/2012, but in each case only with reference to transaction data concerning financial instruments; (ii) an approved publication arrangement as defined in point (52) of Article 4(1) of Directive 2014/65/EU or a consolidated tape provider as defined in point (53) of Article 4(1) of Directive 2014/65/EU, in accordance with mandatory post-trade transparency requirements, but only with reference to transaction data concerning financial instruments that are traded on a trading venue; (iii) an approved reporting mechanism as defined in point (54) of Article 4(1) of Directive 2014/65/EU, but only with reference to transaction data concerning financial instruments that are traded on a trading venue and that must be disclosed in accordance with mandatory post-trade transparency requirements; (iv) an electricity exchange as referred to in point (j) of Article 37(1) of Directive 2009/72/EC of the European Parliament and of the Council (23); (v) a natural gas exchange as referred to in point (j) of Article 41(1) of Directive 2009/73/EC of the European Parliament and of the Council (24); (vi) an auction platform referred to in Article 26 or 30 of Commission Regulation (EU) No 1031/2010 (25); (vii) a service provider to which the benchmark administrator has outsourced the data collection in accordance with Article 10, provided that the service provider receives the data entirely and directly from an entity referred to in points (i) to (vi); (b) net asset values of investment funds; (25) \u2018critical benchmark\u2019 means a benchmark other than a regulated-data benchmark that fulfils any of the conditions laid down in Article 20(1) and which is on the list established by the Commission pursuant to that Article; (26) \u2018significant benchmark\u2019 means a benchmark that fulfils the conditions laid down in Article 24(1); (27) \u2018non-significant benchmark\u2019 means a benchmark that does not fulfil the conditions laid down in Articles 20(1) and 24(1); (28) \u2018located\u2019 means, in relation to a legal person, the country where that person's registered office or other official address is situated and, in relation to a natural person, the country where that person is resident for tax purposes; (29) \u2018public authority\u2019 means: (a) any government or other public administration, including the entities charged with or intervening in the management of the public debt; (b) any entity or person either performing public administrative functions under national law or having public responsibilities or functions or providing public services, including measures of employment, economic activities and inflation, under the control of an entity within the meaning of point (a). 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 49 in order to specify further technical elements of the definitions laid down in paragraph 1 of this Article, in particular specifying what constitutes making available to the public for the purposes of the definition of an index. Where applicable, the Commission shall take into account the market or technological developments and the international convergence of supervisory practice in relation to benchmarks. 3. The Commission shall adopt implementing acts in order to establish and review a list of public authorities in the Union falling within the definition under point (29) of paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 50(2). Where applicable, the Commission shall take into account the market or technological developments and the international convergence of supervisory practice in relation to benchmarks. TITLE II BENCHMARK INTEGRITY AND RELIABILITY CHAPTER 1 Governance of and control by administrators Article 4 Governance and conflict of interest requirements 1. An administrator shall have in place robust governance arrangements which include a clear organisational structure with well-defined, transparent and consistent roles and responsibilities for all persons involved in the provision of a benchmark. Administrators shall take adequate steps to identify and to prevent or manage conflicts of interest between themselves, including their managers, employees or any person directly or indirectly linked to them by control, and contributors or users, and to ensure that, where any judgement or discretion in the benchmark determination process is required, it is independently and honestly exercised. 2. The provision of a benchmark shall be operationally separated from any part of an administrator's business that may create an actual or potential conflict of interest. 3. Where a conflict of interest arises within an administrator due to the latter's ownership structure, controlling interests or other activities conducted by any entity owning or controlling the administrator or by an entity that is owned or controlled by the administrator or any of the administrator's affiliates, that cannot be adequately mitigated, the relevant competent authority may require the administrator to establish an independent oversight function which shall include a balanced representation of stakeholders, including users and contributors. 4. If such a conflict of interest cannot be adequately managed, the relevant competent authority may require the administrator to either cease the activities or relationships that create the conflict of interest or cease providing the benchmark. 5. An administrator shall publish or disclose all existing or potential conflicts of interest to users of a benchmark, to the relevant competent authority and, where relevant, to contributors, including conflicts of interest arising from the ownership or control of the administrator. 6. An administrator shall establish and operate adequate policies and procedures, as well as effective organisational arrangements, for the identification, disclosure, prevention, management and mitigation of conflicts of interest in order to protect the integrity and independence of benchmark determinations. Such policies and procedures shall be regularly reviewed and updated. The policies and procedures shall take into account and address conflicts of interest, the degree of discretion exercised in the benchmark determination process and the risks that the benchmark poses, and shall: (a) ensure the confidentiality of information contributed to or produced by the administrator, subject to the disclosure and transparency obligations under this Regulation; and (b) specifically mitigate conflicts of interest due to the administrator's ownership or control, or due to other interests in the administrator's group or as a result of other persons that may exercise influence or control over the administrator in relation to determining the benchmark. 7. Administrators shall ensure that their employees and any other natural persons whose services are placed at their disposal or under their control and who are directly involved in the provision of a benchmark: (a) have the necessary skills, knowledge and experience for the duties assigned to them and are subject to effective management and supervision; (b) are not subject to undue influence or conflicts of interest and that the compensation and performance evaluation of those persons do not create conflicts of interest or otherwise impinge upon the integrity of the benchmark determination process; (c) do not have any interests or business connections that compromise the activities of the administrator concerned; (d) are prohibited from contributing to a benchmark determination by way of engaging in bids, offers and trades on a personal basis or on behalf of market participants, except where such way of contribution is explicitly required as part of the benchmark methodology and is subject to specific rules therein; and (e) are subject to effective procedures to control the exchange of information with other employees involved in activities that may create a risk of conflicts of interest or with third parties, where that information may affect the benchmark. 8. An administrator shall establish specific internal control procedures to ensure the integrity and reliability of the employee or person determining the benchmark, including at least internal sign-off by management before the dissemination of the benchmark. Article 5 Oversight function requirements 1. Administrators shall establish and maintain a permanent and effective oversight function to ensure oversight of all aspects of the provision of their benchmarks. 2. Administrators shall develop and maintain robust procedures regarding their oversight function, which shall be made available to the relevant competent authorities. 3. The oversight function shall operate with integrity and shall have the following responsibilities, which shall be adjusted by the administrator based on the complexity, use and vulnerability of the benchmark: (a) reviewing the benchmark's definition and methodology at least annually; (b) overseeing any changes to the benchmark methodology and being able to request the administrator to consult on such changes; (c) overseeing the administrator's control framework, the management and operation of the benchmark, and, where the benchmark is based on input data from contributors, the code of conduct referred to in Article 15; (d) reviewing and approving procedures for cessation of the benchmark, including any consultation about a cessation; (e) overseeing any third party involved in the provision of the benchmark, including calculation or dissemination agents; (f) assessing internal and external audits or reviews, and monitoring the implementation of identified remedial actions; (g) where the benchmark is based on input data from contributors, monitoring the input data and contributors and the actions of the administrator in challenging or validating contributions of input data; (h) where the benchmark is based on input data from contributors, taking effective measures in respect of any breaches of the code of conduct referred to in Article 15; and (i) reporting to the relevant competent authorities any misconduct by contributors, where the benchmark is based on input data from contributors, or administrators, of which the oversight function becomes aware, and any anomalous or suspicious input data. 4. The oversight function shall be carried out by a separate committee or by means of another appropriate governance arrangement. 5. ESMA shall develop draft regulatory technical standards to specify the procedures regarding the oversight function and the characteristics of the oversight function including its composition as well as its positioning within the organisational structure of the administrator, so as to ensure the integrity of the function and the absence of conflicts of interest. In particular, ESMA shall develop a non-exhaustive list of appropriate governance arrangements as laid down in paragraph 4. ESMA shall distinguish between the different types of benchmarks and sectors as set out in this Regulation and shall take into consideration the differences in the ownership and control structure of administrators, the nature, scale and complexity of the provision of the benchmark, and the risk and impact of the benchmark, also in light of international convergence of supervisory practice in relation to governance requirements of benchmarks. However, the ESMA draft regulatory technical standards shall not cover or apply to administrators of non-significant benchmarks. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. 6. ESMA may issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010, addressed to administrators of non-significant benchmarks to specify the elements referred to in paragraph 5 of this Article. Article 6 Control framework requirements 1. Administrators shall have in place a control framework that ensures that their benchmarks are provided and published or made available in accordance with this Regulation. 2. The control framework shall be proportionate to the level of conflicts of interest identified, the extent of discretion in the provision of the benchmark and the nature of the benchmark input data. 3. The control framework shall include: (a) management of operational risk; (b) adequate and effective business continuity and disaster recovery plans; (c) contingency procedures that are in place in the event of a disruption to the process of the provision of the benchmark. 4. An administrator shall establish measures to: (a) ensure that contributors adhere to the code of conduct referred to in Article 15 and comply with the applicable standards for input data; (b) monitor input data including, where feasible, monitoring input data before publication of the benchmark and validating input data after publication to identify errors and anomalies. 5. The control framework shall be documented, reviewed and updated as appropriate and made available to the relevant competent authority and, upon request, to users. Article 7 Accountability framework requirements 1. An administrator shall have in place an accountability framework, covering record-keeping, auditing and review, and a complaints process, that provides evidence of compliance with the requirements of this Regulation. 2. An administrator shall designate an internal function with the necessary capability to review and report on the administrator's compliance with the benchmark methodology and this Regulation. 3. For critical benchmarks, an administrator shall appoint an independent external auditor to review and report on the administrator's compliance with the benchmark methodology and this Regulation, at least annually. 4. Upon the request of the relevant competent authority, an administrator shall provide to the relevant competent authority the details of the reviews and reports provided for in paragraph 2. Upon the request of the relevant competent authority or any user of a benchmark, an administrator shall publish the details of the audits provided for in paragraph 3. Article 8 Record-keeping requirements 1. An administrator shall keep records of: (a) all input data, including the use of such data; (b) the methodology used for the determination of a benchmark; (c) any exercise of judgement or discretion by the administrator and, where applicable, by assessors, in the determination of a benchmark, including the reasoning for said judgement or discretion; (d) the disregard of any input data, in particular where it conformed to the requirements of the benchmark methodology, and the rationale for such disregard; (e) other changes in or deviations from standard procedures and methodologies, including those made during periods of market stress or disruption; (f) the identities of the submitters and of the natural persons employed by the administrator for the determination of a benchmark; (g) all documents relating to any complaint, including those submitted by a complainant; and (h) telephone conversations or electronic communications between any person employed by the administrator and contributors or submitters in respect of a benchmark. 2. An administrator shall keep the records set out in paragraph 1 for at least five years in such a form that it is possible to replicate and fully understand the determination of a benchmark and enable an audit or evaluation of input data, calculations, judgements and discretion. Records of telephone conversation or electronic communications recorded in accordance with point (h) of paragraph 1 shall be provided to the persons involved in the conversation or communication upon request and shall be kept for a period of three years. Article 9 Complaints-handling mechanism 1. An administrator shall have in place and publish procedures for receiving, investigating and retaining records concerning complaints made, including about the administrator's benchmark determination process. 2. Such a complaints-handling mechanism shall ensure that: (a) the administrator makes available the complaints-handling policy through which complaints may be submitted on whether a specific benchmark determination is representative of market value, on a proposed change to the benchmark determination process, on an application of the methodology in relation to a specific benchmark determination, and on other decisions in relation to the benchmark determination process; (b) complaints are investigated in a timely and fair manner and the outcome of the investigation is communicated to the complainant within a reasonable period of time, unless such communication would be contrary to objectives of public policy or to Regulation (EU) No 596/2014; and (c) the inquiry is conducted independently of any personnel who may be or may have been involved in the subject-matter of the complaint. Article 10 Outsourcing 1. An administrator shall not outsource functions in the provision of a benchmark in such a way as to impair materially the administrator's control over the provision of the benchmark or the ability of the relevant competent authority to supervise the benchmark. 2. Where an administrator outsources to a service provider functions or any relevant services and activities in the provision of a benchmark, the administrator shall remain fully responsible for discharging all of the administrator's obligations under this Regulation. 3. Where outsourcing takes place, the administrator shall ensure that the following conditions are fulfilled: (a) the service provider has the ability, capacity, and any authorisation required by law, to perform the outsourced functions, services or activities reliably and professionally; (b) the administrator makes available to the relevant competent authorities the identity and the tasks of the service provider that participates in the benchmark determination process; (c) the administrator takes appropriate action if it appears that the service provider may not be carrying out the outsourced functions effectively and in compliance with applicable law and regulatory requirements; (d) the administrator retains the necessary expertise to supervise the outsourced functions effectively and to manage the risks associated with the outsourcing; (e) the service provider discloses to the administrator any development that may have a material impact on its ability to carry out the outsourced functions effectively and in compliance with applicable law and regulatory requirements; (f) the service provider cooperates with the relevant competent authority regarding the outsourced activities, and the administrator and the relevant competent authority have effective access to data related to the outsourced activities, as well as to the business premises of the service provider, and the relevant competent authority is able to exercise those rights of access; (g) the administrator is able to terminate the outsourcing arrangements where necessary; (h) the administrator takes reasonable steps, including contingency plans, to avoid undue operational risk related to the participation of the service provider in the benchmark determination process. CHAPTER 2 Input data, methodology and reporting of infringements Article 11 Input data 1. The provision of a benchmark shall be governed by the following requirements in respect of its input data: (a) the input data shall be sufficient to represent accurately and reliably the market or economic reality that the benchmark is intended to measure. The input data shall be transaction data, if available and appropriate. If transaction data is not sufficient or is not appropriate to represent accurately and reliably the market or economic reality that the benchmark is intended to measure, input data which is not transaction data may be used, including estimated prices, quotes and committed quotes, or other values; (b) the input data referred to in point (a) shall be verifiable; (c) the administrator shall draw up and publish clear guidelines regarding the types of input data, the priority of use of the different types of input data and the exercise of expert judgement, to ensure compliance with point (a) and the methodology; (d) where a benchmark is based on input data from contributors, the administrator shall obtain, where appropriate, the input data from a reliable and representative panel or sample of contributors so as to ensure that the resulting benchmark is reliable and representative of the market or economic reality that the benchmark is intended to measure; (e) the administrator shall not use input data from a contributor if the administrator has any indication that the contributor does not adhere to the code of conduct referred to in Article 15, and in such a case shall obtain representative publicly available data. 2. Administrators shall ensure that their controls in respect of input data include: (a) criteria that determine who may contribute input data to the administrator and a process for selecting contributors; (b) a process for evaluating a contributor's input data and for stopping the contributor from providing further input data, or applying other penalties for non-compliance against the contributor, where appropriate; and (c) a process for validating input data, including against other indicators or data, to ensure its integrity and accuracy. 3. Where the input data of a benchmark is contributed from a front office function, meaning any department, division, group, or personnel of contributors or any of its affiliates that performs any pricing, trading, sales, marketing, advertising, solicitation, structuring, or brokerage activities, the administrator shall: (a) obtain data from other sources that corroborate that input data; and (b) ensure that contributors have in place adequate internal oversight and verification procedures. 4. Where an administrator considers that the input data does not represent the market or economic reality that a benchmark is intended to measure, that administrator shall, within a reasonable time period, either change the input data, the contributors or the methodology in order to ensure that the input data does represent such market or economic reality, or else cease to provide that benchmark. 5. ESMA shall develop draft regulatory technical standards to specify further how to ensure that input data is appropriate and verifiable, as required under points (a) and (b) of paragraph 1, as well as the internal oversight and verification procedures of a contributor that the administrator has to ensure are in place, in compliance with point (b) of paragraph 3, in order to ensure the integrity and accuracy of input data. However, the ESMA draft regulatory technical standards shall not cover or apply to administrators of non-significant benchmarks. ESMA shall take into account the different types of benchmarks and sectors as set out in this Regulation, the nature of input data, the characteristics of the underlying market or economic reality and the principle of proportionality, the vulnerability of the benchmarks to manipulation as well as the international convergence of supervisory practice in relation to benchmarks. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. 6. ESMA may issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010, addressed to administrators of non-significant benchmarks to specify the elements referred to in paragraph 5 of this Article. Article 12 Methodology 1. An administrator shall use a methodology for determining a benchmark that: (a) is robust and reliable; (b) has clear rules identifying how and when discretion may be exercised in the determination of that benchmark; (c) is rigorous, continuous and capable of validation including, where appropriate, back-testing against available transaction data; (d) is resilient and ensures that the benchmark can be calculated in the widest set of possible circumstances, without compromising its integrity; (e) is traceable and verifiable. 2. When developing a benchmark methodology, a benchmark administrator shall: (a) take into account factors including the size and normal liquidity of the market, the transparency of trading and the positions of market participants, market concentration, market dynamics, and the adequacy of any sample to represent the market or economic reality that the benchmark is intended to measure; (b) determine what constitutes an active market for the purposes of that benchmark; and (c) establish the priority given to different types of input data. 3. An administrator shall have in place clear published arrangements that identify the circumstances in which the quantity or quality of input data falls below the standards necessary for the methodology to determine the benchmark accurately and reliably, and that describe whether and how the benchmark is to be calculated in such circumstances. Article 13 Transparency of methodology 1. An administrator shall develop, operate and administer the benchmark and methodology transparently. To that end, the administrator shall publish or make available the following information: (a) the key elements of the methodology that the administrator uses for each benchmark provided and published or, when applicable, for each family of benchmarks provided and published; (b) details of the internal review and the approval of a given methodology, as well as the frequency of such review; (c) the procedures for consulting on any proposed material change in the administrator's methodology and the rationale for such changes, including a definition of what constitutes a material change and the circumstances in which the administrator is to notify users of any such changes. 2. The procedures required under point (c) of paragraph 1 shall provide for: (a) advance notice, with a clear time frame, that gives the opportunity to analyse and comment upon the impact of such proposed material changes; and (b) the comments referred to in point (a) of this paragraph, and the administrator's response to those comments, to be made accessible after any consultation, except where confidentiality has been requested by the originator of the comments. 3. ESMA shall develop draft regulatory technical standards to specify further the information to be provided by an administrator in compliance with the requirements laid down in paragraphs 1 and 2, distinguishing for different types of benchmarks and sectors as set out in this Regulation. ESMA shall take into account the need to disclose those elements of the methodology that provide for sufficient detail to allow users to understand how a benchmark is provided and to assess its representativeness, its relevance to particular users and its appropriateness as a reference for financial instruments and contracts and the principle of proportionality. However, the ESMA draft regulatory technical standards shall not cover or apply to administrators of non-significant benchmarks. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 4. ESMA may issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010, addressed to administrators of non-significant benchmarks to specify further the elements referred to in paragraph 3 of this Article. Article 14 Reporting of infringements 1. An administrator shall establish adequate systems and effective controls to ensure the integrity of input data in order to be able to identify and report to the competent authority any conduct that may involve manipulation or attempted manipulation of a benchmark, under Regulation (EU) No 596/2014. 2. An administrator shall monitor input data and contributors in order to be able to notify the competent authority and provide all relevant information where the administrator suspects that, in relation to a benchmark, any conduct has taken place that may involve manipulation or attempted manipulation of the benchmark, under Regulation (EU) No 596/2014, including collusion to do so. The competent authority of the administrator shall, where applicable, transmit such information to the relevant authority under Regulation (EU) No 596/2014. 3. Administrators shall have procedures in place for their managers, employees and any other natural persons whose services are placed at their disposal or under their control to report internally infringements of this Regulation. CHAPTER 3 Code of conduct and requirements for contributors Article 15 Code of conduct 1. Where a benchmark is based on input data from contributors, its administrator shall develop a code of conduct for each benchmark clearly specifying contributors' responsibilities with respect to the contribution of input data and shall ensure that such code of conduct complies with this Regulation. The administrator shall be satisfied that contributors adhere to the code of conduct on a continuous basis and at least annually and in case of changes to it. 2. The code of conduct shall include at least the following elements: (a) a clear description of the input data to be provided and the requirements necessary to ensure that input data is provided in accordance with Articles 11 and 14; (b) identification of the persons that may contribute input data to the administrator and procedures to verify the identity of a contributor and any submitters, as well as authorisation of any submitters that contribute input data on behalf of a contributor; (c) policies to ensure that a contributor provides all relevant input data; (d) the systems and controls that a contributor is required to establish, including: (i) procedures for contributing input data, including requirements for the contributor to specify whether input data is transaction data and whether input data conforms to the administrator's requirements; (ii) policies on the use of discretion in contributing input data; (iii) any requirement for the validation of input data before it is provided to the administrator; (iv) record-keeping policies; (v) reporting requirements concerning suspicious input data; (vi) requirements concerning the management of conflicts of interest. 3. Administrators may develop a single code of conduct for each family of benchmarks they provide. 4. In the event that a relevant competent authority, in the use of its powers referred to in Article 41, finds that there are elements of a code of conduct which do not comply with this Regulation, it shall notify the administrator concerned. The administrator shall adjust the code of conduct to ensure that it complies with this Regulation within 30 days of such a notification. 5. Within 15 working days from the date of application of the decision to include a critical benchmark in the list referred to in Article 20(1), the administrator of that critical benchmark shall notify the code of conduct to the relevant competent authority. The relevant competent authority shall verify within 30 days whether the content of the code of conduct complies with this Regulation. In the event that the relevant competent authority finds elements which do not comply with this Regulation, paragraph 4 of this Article shall apply. 6. ESMA shall develop draft regulatory technical standards to specify further the elements of the code of conduct referred to in paragraph 2 for different types of benchmarks, and in order to take account of developments in benchmarks and financial markets. ESMA shall take into account the different characteristics of benchmarks and contributors, in particular in terms of differences in input data and methodologies, the risks of input data of being manipulated and international convergence of supervisory practices in relation to benchmarks. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 16 Governance and control requirements for supervised contributors 1. The following governance and control requirements shall apply to a supervised contributor: (a) the supervised contributor shall ensure that the provision of input data is not affected by any existing or potential conflict of interest and that, where any discretion is required, it is independently and honestly exercised based on relevant information in accordance with the code of conduct referred to in Article 15; (b) the supervised contributor shall have in place a control framework that ensures the integrity, accuracy and reliability of input data and that input data is provided in accordance with this Regulation and the code of conduct referred to in Article 15. 2. A supervised contributor shall have in place effective systems and controls to ensure the integrity and reliability of all contributions of input data to the administrator, including: (a) controls regarding who may submit input data to an administrator including, where proportionate, a process for sign-off by a natural person holding a position senior to that of the submitter; (b) appropriate training for submitters, covering at least this Regulation and Regulation (EU) No 596/2014; (c) measures for the management of conflicts of interest, including organisational separation of employees where appropriate and consideration of how to remove incentives, created by remuneration polices, to manipulate a benchmark; (d) record-keeping, for an appropriate period of time, of communications in relation to provision of input data, of all information used to enable the contributor to make each submission, and of all existing or potential conflicts of interest including, but not limited to, the contributor's exposure to financial instruments which use a benchmark as a reference; (e) record-keeping of internal and external audits. 3. Where input data relies on expert judgement, supervised contributors shall establish, in addition to the systems and controls referred to in paragraph 2, policies guiding any use of judgement or exercise of discretion and shall retain records of the rationale for any such judgement or discretion. Where proportionate, supervised contributors shall take into account the nature of the benchmark and its input data. 4. A supervised contributor shall fully cooperate with the administrator and the relevant competent authority in the auditing and supervision of the provision of a benchmark and make available the information and records kept in accordance with paragraphs 2 and 3. 5. ESMA shall develop draft regulatory technical standards to specify further the requirements concerning governance, systems and controls, and policies set out in paragraphs 1, 2 and 3. ESMA shall take into account the different characteristics of benchmarks and supervised contributors, in particular in terms of differences in input data provided and methodologies used, the risks of manipulation of the input data and the nature of the activities carried out by the supervised contributors, and the developments in benchmarks and financial markets in light of international convergence of supervisory practices in relation to benchmarks. However, the ESMA draft regulatory technical standards shall not cover or apply to supervised contributors of non-significant benchmarks. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. 6. ESMA may issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010, addressed to supervised contributors to non-significant benchmarks to specify the elements referred to in paragraph 5 of this Article. TITLE III REQUIREMENTS FOR DIFFERENT TYPES OF BENCHMARKS CHAPTER 1 Regulated-data benchmarks Article 17 Regulated-data benchmarks 1. Article 11(1)(d) and (e), Article 11(2) and (3), Article 14(1) and (2), and Articles 15 and 16 shall not apply to the provision of and the contribution to regulated-data benchmarks. Article 8(1)(a) shall not apply to the provision of regulated-data benchmarks with reference to input data that are contributed entirely and directly as specified in point (24) of Article 3(1). 2. Articles 24 and 25 or Article 26 shall, as applicable, apply to the provision of, and the contribution to, regulated-data benchmarks that are used directly or indirectly within a combination of benchmarks as a reference for financial instruments or financial contracts or for measuring the performance of investment funds, having a total value of up to EUR 500 billion, on the basis of all the range of maturities or tenors of the benchmark, where applicable. CHAPTER 2 Interest rate benchmarks Article 18 Interest rate benchmarks The specific requirements laid down in Annex I shall apply to the provision of, and contribution to, interest rate benchmarks in addition to, or as a substitute for, the requirements of Title II. Articles 24, 25 and 26 shall not apply to the provision of, and contribution to, interest rate benchmarks. CHAPTER 3 Commodity benchmarks Article 19 Commodity benchmarks 1. The specific requirements laid down in Annex II shall apply instead of the requirements of Title II, with the exception of Article 10, to the provision of, and contribution to, commodity benchmarks, unless the benchmark in question is a regulated-data benchmark or is based on submissions by contributors the majority of which are supervised entities. Articles 24, 25 and 26 shall not apply to the provision of, and contribution to, commodity benchmarks. 2. Where a commodity benchmark is a critical benchmark and the underlying asset is gold, silver or platinum, the requirements of Title II shall apply instead of Annex II. CHAPTER 4 Critical benchmarks Article 20 Critical benchmarks 1. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 50(2) to establish and review at least every two years a list of benchmarks provided by administrators located within the Union which are critical benchmarks, provided that one of the following conditions is fulfilled: (a) the benchmark is used directly or indirectly within a combination of benchmarks as a reference for financial instruments or financial contracts or for measuring the performance of investment funds, having a total value of at least EUR 500 billion on the basis of all the range of maturities or tenors of the benchmark, where applicable; (b) the benchmark is based on submissions by contributors the majority of which are located in one Member State and is recognised as being critical in that Member State in accordance with the procedure laid down in paragraphs 2, 3, 4 and 5 of this Article; (c) the benchmark fulfils all of the following criteria: (i) the benchmark is used directly or indirectly within a combination of benchmarks as a reference for financial instruments or financial contracts or for measuring the performance of investment funds having a total value of at least EUR 400 billion on the basis of all the range of maturities or tenors of the benchmark, where applicable, but not exceeding the value provided for in point (a); (ii) the benchmark has no, or very few, appropriate market-led substitutes; (iii) in the event that the benchmark ceases to be provided, or is provided on the basis of input data no longer fully representative of the underlying market or economic reality or on the basis of unreliable input data, there would be significant and adverse impacts on market integrity, financial stability, consumers, the real economy, or the financing of households and businesses in one or more Member States. If a benchmark meets the criteria set out in point (c)(ii) and (iii) but does not meet the criterion set out in point (c)(i), the competent authorities of the Member States concerned together with the competent authority of the Member State where the administrator is established may agree that such benchmark should be recognised as critical under this subparagraph. In any case, the competent authority of the administrator shall consult the competent authorities of the Member States concerned. In the event of disagreement between the competent authorities, the competent authority of the administrator shall decide whether the benchmark should be recognised as critical under this subparagraph, taking into account the reasons for the disagreement. The competent authorities or, in the event of disagreement, the competent authority of the administrator, shall transmit the assessment to the Commission. After receiving the assessment, the Commission shall adopt an implementing act in accordance with this paragraph. In addition, in the event of disagreement, the competent authority of the administrator shall transmit its assessment to ESMA, which may publish an opinion. 2. Where the competent authority of a Member State referred to in point (b) of paragraph 1 considers that an administrator under its supervision provides a benchmark that should be recognised as critical, it shall notify ESMA and transmit to ESMA a documented assessment. 3. For the purposes of paragraph 2, the competent authority shall assess whether the cessation of the benchmark or its provision on the basis of input data or of a panel of contributors no longer representative of the underlying market or economic reality would have an adverse impact on market integrity, financial stability, consumers, the real economy, or the financing of households and businesses in its Member State. The competent authority shall take into consideration in its assessment: (a) the value of financial instruments and financial contracts that reference the benchmark and the value of investment funds referencing the benchmark for measuring their performance within the Member State and their relevance in terms of the total value of financial instruments and of financial contracts outstanding, and of the total value of investment funds, in the Member State; (b) the value of financial instruments and financial contracts that reference the benchmark and the value of investment funds referencing the benchmark for measuring their performance within the Member State and their relevance in terms of the gross national product of the Member State; (c) any other figure to assess on objective grounds the potential impact of the discontinuity or unreliability of the benchmark on market integrity, financial stability, consumers, the real economy, or the financing of households and businesses in the Member State. The competent authority shall review its assessment of the criticality of the benchmark at least every two years, and shall notify and transmit the new assessment to ESMA. 4. Within six weeks of receipt of the notification referred to in paragraph 2, ESMA shall issue an opinion on whether the assessment of the competent authority complies with the requirements of paragraph 3 and shall transmit such opinion to the Commission, together with the competent authority's assessment. 5. The Commission, after receiving the opinion referred to in paragraph 4, shall adopt implementing acts in accordance with paragraph 1. 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 49 in order to: (a) specify how the nominal amount of financial instruments other than derivatives, the notional amount of derivatives and the net asset value of investment funds are to be assessed, including in the event of an indirect reference to a benchmark within a combination of benchmarks, in order to be compared with the thresholds referred to in paragraph 1 of this Article and in point (a) of Article 24(1); (b) review the calculation method used to determine the thresholds referred to in paragraph 1 of this Article in the light of market, price and regulatory developments as well as the appropriateness of the classification of benchmarks with a total value of financial instruments, financial contracts, or investment funds referencing them that is close to the thresholds; such review shall take place at least every two years as from 1 January 2018; (c) specify how the criteria referred to in point (c)(iii) of paragraph 1 of this Article are to be applied, taking into consideration any data which helps assess on objective grounds the potential impact of the discontinuity or unreliability of the benchmark on market integrity, financial stability, consumers, the real economy, or the financing of households and businesses in one or more Member States. Where applicable, the Commission shall take into account relevant market or technological developments. Article 21 Mandatory administration of a critical benchmark 1. If an administrator of a critical benchmark intends to cease providing such benchmark, the administrator shall: (a) immediately notify its competent authority; and (b) within four weeks of such notification submit an assessment of how the benchmark: (i) is to be transitioned to a new administrator; or (ii) is to be ceased to be provided, taking into account the procedure established in Article 28(1). During the period referred to in point (b) of the first subparagraph, the administrator shall not cease provision of the benchmark. 2. Upon receipt of the assessment of the administrator referred to in paragraph 1, the competent authority shall: (a) inform ESMA and, where applicable, the college established under Article 46; and (b) within four weeks, make its own assessment of how the benchmark is to be transitioned to a new administrator or be ceased to be provided, taking into account the procedure established in accordance with Article 28(1). During the period of time referred to in point (b) of the first subparagraph of this paragraph, the administrator shall not cease the provision of the benchmark without the written consent of the competent authority. 3. Following completion of the assessment referred to in point (b) of paragraph 2, the competent authority shall have the power to compel the administrator to continue publishing the benchmark until such time as: (a) the provision of the benchmark has been transitioned to a new administrator; (b) the benchmark can be ceased to be provided in an orderly fashion; or (c) the benchmark is no longer critical. For the purposes of the first subparagraph, the period for which the competent authority may compel the administrator to continue to publish the benchmark shall not exceed 12 months. By the end of that period, the competent authority shall review its decision to compel the administrator to continue to publish the benchmark and may, where necessary, extend the time period by an appropriate period not exceeding a further 12 months. The maximum period of mandatory administration shall not exceed 24 months in total. 4. Without prejudice to paragraph 1, in the event that the administrator of a critical benchmark is to be wound down due to insolvency proceedings, the competent authority shall make an assessment of whether and how the critical benchmark can be transitioned to a new administrator or can cease to be provided in an orderly fashion, taking into account the procedure established in accordance with Article 28(1). Article 22 Mitigation of market power of critical benchmark administrators Without prejudice to the application of Union competition law, when providing a critical benchmark, the administrator shall take adequate steps to ensure that licences of, and information relating to, the benchmark are provided to all users on a fair, reasonable, transparent and non-discriminatory basis. Article 23 Mandatory contribution to a critical benchmark 1. This Article shall apply to critical benchmarks based on submissions by contributors the majority of which are supervised entities. 2. Administrators of one or more critical benchmarks shall, every two years, submit to their competent authority an assessment of the capability of each critical benchmark they provide to measure the underlying market or economic reality. 3. If a supervised contributor to a critical benchmark intends to cease contributing input data, it shall promptly notify in writing the benchmark administrator, which shall inform without delay its competent authority. Where the supervised contributor is located in another Member State, the competent authority of the administrator shall inform, without delay, the competent authority of that contributor. The benchmark administrator shall submit to its competent authority an assessment of the implications on the capability of the benchmark to measure the underlying market or economic reality as soon as possible but no later than 14 days after the notification made by the supervised contributor. 4. Upon receipt of an assessment of the benchmark administrator referred to in paragraphs 2 and 3 of this Article and on the basis of such assessment, the competent authority of the administrator shall promptly inform ESMA and, where applicable, the college established under Article 46, and make its own assessment on the capability of the benchmark to measure the underlying market and economic reality, taking into account the administrator's procedure for cessation of the benchmark established in accordance with Article 28(1). 5. From the date on which the competent authority of the administrator is notified of the intention of a contributor to cease contributing input data and until such time as the assessment referred to in paragraph 4 is complete, it shall have the power to require the contributors which made the notification in accordance with paragraph 3 to continue contributing input data, in any event for a period of no more than four weeks, without imposing an obligation on supervised entities to either trade or commit to trade. 6. In the event that the competent authority, after the period specified in paragraph 5 and on the basis of its own assessment referred to in paragraph 4, considers that the representativeness of a critical benchmark is put at risk, it shall have the power to: (a) require supervised entities selected in accordance with paragraph 7 of this Article, including entities that are not yet contributors to the relevant critical benchmark, to contribute input data to the administrator in accordance with the administrator's methodology, the code of conduct referred to in Article 15 and other rules. Such requirement shall be in place for an appropriate period of time not exceeding 12 months from the date on which the initial decision requiring mandatory contribution was taken pursuant to paragraph 5 or, for those entities that are not yet contributors, from the date on which the decision requiring mandatory contribution is taken under this point; (b) extend the period of mandatory contribution by an appropriate period of time not exceeding 12 months, following a review under paragraph 9 of any measures adopted pursuant to point (a) of this paragraph; (c) determine the form in which, and the time by which, any input data is to be contributed without imposing an obligation on supervised entities to either trade or commit to trade; (d) require the administrator to change the methodology, the code of conduct referred to in Article 15 or other rules of the critical benchmark. The maximum period of mandatory contribution under points (a) and (b) of the first subparagraph shall not exceed 24 months in total. 7. For the purposes of paragraph 6, supervised entities that are to be required to contribute input data shall be selected by the competent authority of the administrator, with the close cooperation of the competent authorities of the supervised entities, on the basis of the size of the supervised entity's actual and potential participation in the market that the benchmark intends to measure. 8. The competent authority of a supervised contributor that has been required to contribute to a benchmark through measures taken in accordance with point (a), (b) or (c) of paragraph 6 shall cooperate with the competent authority of the administrator in the enforcement of such measures. 9. By the end of the period referred to in point (a) of the first subparagraph of paragraph 6, the competent authority of the administrator shall review the measures adopted under paragraph 6. It shall revoke any of them if it considers that: (a) the contributors are likely to continue contributing input data for at least one year if the measure were revoked, which shall be evidenced by at least: (i) a written commitment by the contributors to the administrator and the competent authority to continue contributing input data to the critical benchmark for at least one year if the measure were revoked; (ii) a written report by the administrator to the competent authority providing evidence for its assessment that the critical benchmark's continued viability can be assured once mandatory contribution has been revoked; (b) the provision of the benchmark is able to continue once the contributors mandated to contribute input data have ceased contributing; (c) an acceptable substitute benchmark is available and users of the critical benchmark can switch to this substitute at minimal costs which shall be evidenced by at least a written report by the administrator detailing the means of transition to a substitute benchmark and the ability and costs to users of transitioning to this benchmark; or (d) no appropriate alternative contributors can be identified and the cessation of contributions from the relevant supervised entities would weaken the benchmark to such an extent to require the cessation of the benchmark. 10. In the event that a critical benchmark is to be ceased to be provided, each supervised contributor to that benchmark shall continue to contribute input data for a period of time determined by the competent authority, but not exceeding the maximum 24-month period laid down in the second subparagraph of paragraph 6. 11. The administrator shall notify the relevant competent authority in the event that any contributors breach the requirements set out in paragraph 6 as soon as reasonably possible. 12. In the event that a benchmark is recognised as critical in accordance with the procedure laid down in Article 20(2), (3), (4) and (5), the competent authority of the administrator shall have the power to require input data in accordance with paragraph 5, and points (a), (b) and (c) of paragraph 6, of this Article only from supervised contributors located in its Member State. CHAPTER 5 Significant benchmarks Article 24 Significant benchmarks 1. A benchmark which does not fulfil any of the conditions laid down in Article 20(1) is significant when: (a) it is used directly or indirectly within a combination of benchmarks as a reference for financial instruments or financial contracts or for measuring the performance of investments funds having a total average value of at least EUR 50 billion on the basis of all the range of maturities or tenors of the benchmark, where applicable, over a period of six months; or (b) it has no or very few appropriate market-led substitutes and, in the event that the benchmark ceases to be provided or is provided on the basis of input data no longer fully representative of the underlying market or economic reality or unreliable input data, there would be a significant and adverse impact on market integrity, financial stability, consumers, the real economy or the financing of households or businesses in one or more Member States. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 49 in order to review the calculation method used to determine the threshold referred to in point (a) of paragraph 1 of this Article in the light of market, price and regulatory developments as well as the appropriateness of the classification of benchmarks with a total value of financial instruments, financial contracts or investment funds referencing them that is close to that threshold. Such review shall take place at least every two years as from 1 January 2018. 3. An administrator shall immediately notify its competent authority when its significant benchmark falls below the threshold mentioned in point (a) of paragraph 1. Article 25 Exemptions from specific requirements for significant benchmarks 1. An administrator may choose not to apply Article 4(2), points (c), (d) and (e) of Article 4(7), point (b) of Article 11(3) or Article 15(2) with respect to its significant benchmark where that administrator considers that the application of one or more of those provisions would be disproportionate taking into account the nature or impact of the benchmark or the size of the administrator. 2. In the event that an administrator chooses not to apply one or more of the provisions referred to in paragraph 1, it shall immediately notify the competent authority and provide it with all relevant information confirming the administrator's assessment that the application of one or more of those provisions would be disproportionate taking into account the nature or impact of the benchmarks or the size of the administrator. 3. A competent authority may decide that the administrator of a significant benchmark is nevertheless to apply one or more of the requirements laid down in Article 4(2), points (c), (d) and (e) of Article 4(7), point (b) of Article 11(3) and Article 15(2) if it considers that it would be appropriate taking into account the nature or the impact of the benchmarks or the size of the administrator. In its assessment, the competent authority shall, based on the information provided by the administrator, take into account the following criteria: (a) the vulnerability of the benchmark to manipulation; (b) the nature of the input data; (c) the level of conflicts of interest; (d) the degree of discretion of the administrator; (e) the impact of the benchmark on markets; (f) the nature, scale and complexity of the provision of the benchmark; (g) the importance of the benchmark to financial stability; (h) the value of financial instruments, financial contracts or investment funds that reference the benchmark; (i) the administrator's size, organisational form or structure. 4. Within 30 days of receipt of a notification from an administrator under paragraph 2, the competent authority shall notify that administrator of its decision to apply an additional requirement pursuant to paragraph 3. In the event that the notification to the competent authority is made during the course of an authorisation or registration procedure, the deadlines set out in Article 34 shall apply. 5. When exercising its supervisory powers in accordance with Article 41, a competent authority shall regularly review whether its assessment pursuant to paragraph 3 of this Article is still valid. 6. If a competent authority finds, on reasonable grounds, that the information submitted to it pursuant to paragraph 2 of this Article is incomplete or that supplementary information is needed, the 30-day time limit referred to in paragraph 4 of this Article shall apply only from the date on which such complementary information is provided by the administrator, unless the deadlines of Article 34 apply pursuant to paragraph 4 of this Article. 7. Where an administrator of a significant benchmark does not comply with one or more of the requirements laid down in Article 4(2), points (c), (d) and (e) of Article 4(7), point (b) of Article 11(3) and Article 15(2), it shall publish and maintain a compliance statement that clearly states why it is appropriate for that administrator not to comply with those provisions. 8. ESMA shall develop draft implementing technical standards to develop a template for the compliance statement referred to in paragraph 7. ESMA shall submit the draft implementing technical standards referred to in the first subparagraph to the Commission by 1 April 2017. Power is conferred to the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. 9. ESMA shall develop draft regulatory technical standards to specify further the criteria referred to in paragraph 3. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. CHAPTER 6 Non-significant benchmarks Article 26 Non-significant benchmarks 1. An administrator may choose not to apply Articles 4(2), points (c), (d) and (e) of Article 4(7), Articles 4(8), 5(2), 5(3), 5(4), 6(1), 6(3), 6(5), 7(2), point (b) of Article 11(1), points (b) and (c) of Article 11(2), and Articles 11(3), 13(2), 14(2), 15(2), 16(2) and (3) with respect to its non-significant benchmarks. 2. An administrator shall immediately notify its competent authority when the administrator's non-significant benchmark exceeds the threshold mentioned in point (a) of Article 24(1). In that case, it shall comply with the requirements applicable to significant benchmarks within three months. 3. Where an administrator of a non-significant benchmark chooses not to apply one or more of the provisions referred to in paragraph 1, it shall publish and maintain a compliance statement which shall clearly state why it is appropriate for that administrator not to comply with those provisions. The administrator shall provide the compliance statement to its competent authority. 4. The relevant competent authority shall review the compliance statement referred to in paragraph 3 of this Article. The competent authority may also request additional information from the administrator in respect of its non-significant benchmarks in accordance with Article 41 and may require changes to ensure compliance with this Regulation. 5. ESMA shall develop draft implementing technical standards to develop a template for the compliance statement referred to in paragraph 3. ESMA shall submit the draft implementing technical standards referred to in the first subparagraph to the Commission by 1 April 2017. Power is conferred to the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. TITLE IV TRANSPARENCY AND CONSUMER PROTECTION Article 27 Benchmark statement 1. Within two weeks of the inclusion of an administrator in the register referred to in Article 36, the administrator shall publish, by means that ensure fair and easy access, a benchmark statement for each benchmark or, where applicable, for each family of benchmarks, that may be used in the Union in accordance with Article 29. Where that administrator begins providing a new benchmark or family of benchmarks that may be used in the Union in accordance with Article 29, the administrator shall publish, within two weeks and by means that ensure a fair and easy access, a benchmark statement for each new benchmark or, where applicable, family of benchmarks. The administrator shall review and, where necessary, update the benchmark statement for each benchmark or family of benchmarks in the event of any changes to the information to be provided under this Article and at least every two years. The benchmark statement shall: (a) clearly and unambiguously define the market or economic reality measured by the benchmark and the circumstances in which such measurement may become unreliable; (b) lay down technical specifications that clearly and unambiguously identify the elements of the calculation of the benchmark in relation to which discretion may be exercised, the criteria applicable to the exercise of such discretion and the position of the persons that can exercise discretion, and how such discretion may be subsequently evaluated; (c) provide notice of the possibility that factors, including external factors beyond the control of the administrator, may necessitate changes to, or the cessation of, the benchmark; and (d) advise users that changes to, or the cessation of, the benchmark may have an impact upon the financial contracts and financial instruments that reference the benchmark or the measurement of the performance of investment funds. 2. A benchmark statement shall contain at least: (a) the definitions for all key terms relating to the benchmark; (b) the rationale for adopting the benchmark methodology and procedures for the review and approval of the methodology; (c) the criteria and procedures used to determine the benchmark, including a description of the input data, the priority given to different types of input data, the minimum data needed to determine a benchmark, the use of any models or methods of extrapolation and any procedure for rebalancing the constituents of a benchmark's index; (d) the controls and rules that govern any exercise of judgement or discretion by the administrator or any contributors, to ensure consistency in the use of such judgement or discretion; (e) the procedures which govern the determination of the benchmark in periods of stress or periods where transaction data sources may be insufficient, inaccurate or unreliable and the potential limitations of the benchmark in such periods; (f) the procedures for dealing with errors in input data or in the determination of the benchmark, including when a re-determination of the benchmark is required; and (g) the identification of potential limitations of the benchmark, including its operation in illiquid or fragmented markets and the possible concentration of inputs. 3. ESMA shall develop draft regulatory technical standards to specify further the contents of a benchmark statement and the cases in which an update of such statement is required. ESMA shall distinguish between the different types of benchmarks and sectors as set out in this Regulation and shall take into account the principle of proportionality. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 28 Changes to and cessation of a benchmark 1. An administrator shall publish, together with the benchmark statement referred to in Article 27, a procedure concerning the actions to be taken by the administrator in the event of changes to or the cessation of a benchmark which may be used in the Union in accordance with Article 29(1). The procedure may be drafted, where applicable, for families of benchmarks and shall be updated and published whenever a material change occurs. 2. Supervised entities other than an administrator as referred to in paragraph 1 that use a benchmark shall produce and maintain robust written plans setting out the actions that they would take in the event that a benchmark materially changes or ceases to be provided. Where feasible and appropriate, such plans shall nominate one or several alternative benchmarks that could be referenced to substitute the benchmarks no longer provided, indicating why such benchmarks would be suitable alternatives. The supervised entities shall, upon request, provide the relevant competent authority with those plans and any updates and shall reflect them in the contractual relationship with clients. TITLE V USE OF BENCHMARKS IN THE UNION Article 29 Use of a benchmark 1. A supervised entity may use a benchmark or a combination of benchmarks in the Union if the benchmark is provided by an administrator located in the Union and included in the register referred to in Article 36 or is a benchmark which is included in the register referred to in Article 36. 2. Where the object of a prospectus to be published under Directive 2003/71/EC or Directive 2009/65/EC is transferable securities or other investment products that reference a benchmark, the issuer, offeror, or person asking for admission to trade on a regulated market shall ensure that the prospectus also includes clear and prominent information stating whether the benchmark is provided by an administrator included in the register referred to in Article 36 of this Regulation. Article 30 Equivalence 1. In order for a benchmark or a combination of benchmarks provided by an administrator located in a third country to be used in the Union in accordance with Article 29(1), the benchmark and the administrator shall be included in the register referred to in Article 36. The following conditions shall be complied with in order to be included in the register: (a) an equivalence decision is adopted by the Commission in accordance with paragraph 2 or 3 of this Article; (b) the administrator is authorised or registered, and is subject to supervision, in the third country in question; (c) ESMA is notified by the administrator of its consent that its actual or prospective benchmarks may be used by supervised entities in the Union, of the list of the benchmarks for which they have given consent to be used in the Union and of the competent authority responsible for its supervision in the third country; and (d) the cooperation arrangements referred to in paragraph 4 of this Article are operational. 2. The Commission may adopt an implementing decision stating that the legal framework and supervisory practice of a third country ensures that: (a) administrators authorised or registered in that third country comply with binding requirements which are equivalent to the requirements under this Regulation, in particular taking account of whether the legal framework and supervisory practice of a third country ensures compliance with the IOSCO principles for financial benchmarks or, where applicable, with the IOSCO principles for PRAs; and (b) the binding requirements are subject to effective supervision and enforcement on an on-going basis in that third country. Such implementing decision shall be adopted in accordance with the examination procedure referred to in Article 50(2). 3. Alternatively, the Commission may adopt an implementing decision stating that: (a) binding requirements in a third country with respect to specific administrators or specific benchmarks or families of benchmarks are equivalent to the requirements under this Regulation, in particular taking account of whether the legal framework and supervisory practice of a third country ensures compliance with the IOSCO principles for financial benchmarks or, where applicable, with the IOSCO principles for PRAs; and (b) such specific administrators or specific benchmarks or families of benchmarks are subject to effective supervision and enforcement on an on-going basis in that third country. Such implementing decision shall be adopted in accordance with the examination procedure referred to in Article 50(2). 4. ESMA shall establish cooperation arrangements with the competent authorities of third countries whose legal framework and supervisory practices have been recognised as equivalent in accordance with paragraph 2 or 3. Such arrangements shall specify at least: (a) the mechanism for the exchange of information between ESMA and the competent authorities of third countries concerned, including access to all relevant information regarding the administrator authorised in that third country that is requested by ESMA; (b) the mechanism for prompt notification to ESMA where a third country competent authority deems that the administrator authorised in that third country that it is supervising is in breach of the conditions of its authorisation or other national legislation in the third country; (c) the procedures concerning the coordination of supervisory activities, including on-site inspections. 5. ESMA shall develop draft regulatory technical standards to determine the minimum content of the cooperation arrangements referred to in paragraph 4 so as to ensure that the competent authorities and ESMA are able to exercise all their supervisory powers under this Regulation. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 31 Withdrawal of registration of an administrator located in a third country 1. ESMA shall withdraw the registration of an administrator located in a third country by removing that administrator from the register referred to in Article 36 where it has well-founded reasons, based on documented evidence, that the administrator: (a) is acting in a manner which is clearly prejudicial to the interests of the users of its benchmarks or the orderly functioning of markets; or (b) has seriously infringed the national legislation in the third country or other provisions applicable to it in the third country and on the basis of which the Commission has adopted the implementing decision in accordance with Article 30(2) or (3). 2. ESMA shall take a decision under paragraph 1 only if the following conditions are fulfilled: (a) ESMA has referred the matter to the competent authority of the third country and that competent authority has not taken the appropriate measures needed to protect investors and the orderly functioning of the markets in the Union, or has failed to demonstrate that the administrator concerned complies with the requirements applicable to it in the third country; (b) ESMA has informed the competent authority of the third country of its intention to withdraw the registration of the administrator, at least 30 days before the withdrawal. 3. ESMA shall inform the other competent authorities of any measure adopted in accordance with paragraph 1 without delay and shall publish its decision on its website. Article 32 Recognition of an administrator located in a third country 1. Until such time as an equivalence decision in accordance with Article 30(2) or (3) is adopted, a benchmark provided by an administrator located in a third country may be used by supervised entities in the Union provided that the administrator acquires prior recognition by the competent authority of its Member State of reference in accordance with this Article. 2. An administrator located in a third country intending to obtain prior recognition as referred to in paragraph 1 of this Article shall comply with the requirements established in this Regulation, excluding Article 11(4) and Articles 16, 20, 21 and 23. The administrator may fulfil that condition by applying the IOSCO principles for financial benchmarks or the IOSCO principles for PRAs, as applicable, provided that such application is equivalent to compliance with the requirements established in this Regulation, excluding Article 11(4), and Articles 16, 20, 21 and 23. For the purposes of determining whether the condition referred to in the first subparagraph is fulfilled, and in order to assess compliance with the IOSCO principles for financial benchmarks or the IOSCO principles for PRAs, as applicable, the competent authority of the Member State of reference may rely on an assessment by an independent external auditor or, where the administrator located in a third country is subject to supervision, on the certification provided by the competent authority of the third country where the administrator is located. If, and to the extent that, an administrator is able to demonstrate that a benchmark it provides is a regulated-data benchmark or a commodity benchmark that is not based on submissions by contributors the majority of which are supervised entities, there shall be no obligation on the administrator to comply with requirements not applicable to the provision of regulated-data benchmarks and of commodity benchmarks as provided for in Article 17 and Article 19(1) respectively. 3. An administrator located in a third country intending to obtain prior recognition as referred to in paragraph 1 shall have a legal representative established in its Member State of reference. The legal representative shall be a natural or legal person located in the Union, and which, expressly appointed by the administrator located in a third country, acts on behalf of such administrator vis-\u00e0-vis the authorities and any other person in the Union with regard to the administrator's obligations under this Regulation. The legal representative shall perform the oversight function relating to the provision of benchmarks performed by the administrator under this Regulation together with the administrator and, in that respect, shall be accountable to the competent authority of the Member State of reference. 4. The Member State of reference of an administrator located in a third country shall be determined as follows: (a) where an administrator is part of a group that contains one supervised entity located in the Union, the Member State of reference shall be the Member State where that supervised entity is located. Such supervised entity shall be appointed as the legal representative for the purposes of paragraph 3; (b) if point (a) does not apply, where an administrator is part of a group that contains more than one supervised entity located in the Union, the Member State of reference shall be the Member State where the highest number of supervised entities are located or, in the event that there is an equal number of supervised entities, the Member State of reference shall be the one where the value of financial instruments, financial contracts or investment funds that reference the benchmark is highest. One of the supervised entities located in the Member State of reference determined pursuant to this point shall be appointed as the legal representative for the purposes of paragraph 3; (c) if neither point (a) nor (b) of this paragraph applies, where one or more benchmarks provided by the administrator are used as a reference for financial instruments admitted to trading in a trading venue as defined in point (24) of Article 4(1) of Directive 2014/65/EU in one or more Member States, the Member State of reference shall be the Member State where the financial instrument referencing any of those benchmarks was admitted to trading or traded on a trading venue for the first time and is still traded. If the relevant financial instruments were admitted to trading or traded for the first time simultaneously on trading venues in different Member States, and are still traded, the Member State of reference shall be the one where the value of financial instruments, financial contracts or investment funds that reference the benchmark is highest; (d) if points (a), (b) and (c) do not apply, where one or more benchmarks provided by the administrator are used by supervised entities in more than one Member State, the Member State of reference shall be the Member State where the highest number of such supervised entities are located or, in the event that there is an equal number of supervised entities, the Member State of reference shall be the one where the value of financial instruments, financial contracts or investment funds that reference the benchmark is highest; (e) if points (a), (b), (c) and (d) do not apply and if the administrator enters into an agreement consenting to the use of a benchmark it provides with a supervised entity, the Member State of reference shall be the Member State where such supervised entity is located. 5. An administrator located in a third country intending to obtain prior recognition as referred to in paragraph 1 shall apply for recognition with the competent authority of its Member State of reference. The applicant administrator shall provide all information necessary to satisfy the competent authority that it has established, at the time of recognition, all the necessary arrangements to meet the requirements referred to in paragraph 2 and shall provide the list of its actual or prospective benchmarks which may be used in the Union and shall, where applicable, indicate the competent authority responsible for its supervision in the third country. Within 90 working days of receipt of the application referred to in the first subparagraph of this paragraph, the competent authority shall verify that the conditions laid down in paragraphs 2, 3 and 4 are fulfilled. If the competent authority considers that the conditions laid down in paragraphs 2, 3 and 4 are not fulfilled, it shall refuse the recognition request and set out the reasons for that refusal. In addition, no recognition shall be granted unless the following additional conditions are fulfilled: (a) where an administrator located in a third country is subject to supervision, an appropriate cooperation arrangement is in place between the competent authority of the Member State of reference and the competent authority of the third country where the administrator is located, in compliance with the regulatory technical standards adopted pursuant to Article 30(5), in order to ensure an efficient exchange of information that allows the competent authority to carry out its duties in accordance with this Regulation; (b) the effective exercise by the competent authority of its supervisory functions under this Regulation is neither prevented by the laws, regulations or administrative provisions of the third country where the administrator is located, nor, where applicable, by limitations in the supervisory and investigatory powers of that third country's supervisory authority. 6. In the event that the competent authority of the Member State of reference considers that an administrator located in a third country provides a benchmark that fulfils the conditions of a significant or non-significant benchmark, as provided for in Articles 24 and 26 respectively, it shall, without undue delay, notify ESMA thereof. It shall support such assessment with the information provided by the administrator in the relevant application for recognition. Within one month of receipt of the notification referred to in the first subparagraph, ESMA shall issue advice to the competent authority about the type of the benchmark and the requirements applicable to its provision, as provided for in Articles 24, 25 and 26. The advice may, in particular, address whether ESMA considers that the conditions for such type are fulfilled on the basis of the information provided by the administrator in the application for recognition. The period of time referred to in paragraph 5 shall be suspended from the date on which the notification is received by ESMA, until such time as ESMA issues advice in accordance with this paragraph. If the competent authority of the Member State of reference proposes to grant recognition contrary to ESMA's advice referred to in the second subparagraph, it shall inform ESMA thereof, stating its reasons. ESMA shall publish the fact that the competent authority does not comply or intend to comply with that advice. ESMA may also decide, on a case-by-case basis, to publish the reasons provided by the competent authority for not complying with that advice. The competent authority concerned shall receive advance notice of such publication. 7. The competent authority of the Member State of reference shall notify ESMA of any decision to recognise an administrator located in a third country within five working days, along with the list of the benchmarks provided by the administrator which may be used in the Union and, where applicable, the competent authority responsible for its supervision in the third country. 8. The competent authority of the Member State of reference shall suspend or, where appropriate, withdraw the recognition granted in accordance with paragraph 5 if it has well-founded reasons, based on documented evidence, to consider that the administrator is acting in a manner which is clearly prejudicial to the interests of users of its benchmarks or the orderly functioning of markets or the administrator has seriously infringed the relevant requirements set out in this Regulation, or that the administrator made false statements or used any other irregular means to obtain the recognition. 9. ESMA may develop draft regulatory technical standards to determine the form and content of the application referred to in paragraph 5 and, in particular, the presentation of the information required in paragraph 6. In the event that such draft regulatory technical standards are developed, ESMA shall submit them to the Commission. Power is conferred on the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 33 Endorsement of benchmarks provided in a third country 1. An administrator located in the Union and authorised or registered in accordance with Article 34, or any other supervised entity located in the Union with a clear and well-defined role within the control or accountability framework of a third country administrator, which is able to monitor effectively the provision of a benchmark, may apply to the relevant competent authority to endorse a benchmark or a family of benchmarks provided in a third country for their use in the Union, provided that all of the following conditions are fulfilled: (a) the endorsing administrator or other supervised entity has verified and is able to demonstrate on an on-going basis to its competent authority that the provision of the benchmark or family of benchmarks to be endorsed fulfils, on a mandatory or on a voluntary basis, requirements which are at least as stringent as the requirements of this Regulation; (b) the endorsing administrator or other supervised entity has the necessary expertise to monitor effectively the activity of the provision of a benchmark in a third country and to manage the associated risks; (c) there is an objective reason to provide the benchmark or family of benchmarks in a third country and for said benchmark or family of benchmarks to be endorsed for their use in the Union. For the purpose of point (a), when assessing whether the provision of the benchmark or family of benchmarks to be endorsed fulfils requirements which are at least as stringent as the requirements of this Regulation, the competent authority may take into account whether the compliance of the provision of the benchmark or family of benchmarks with the IOSCO principles for financial benchmarks or the IOSCO principles for PRAs, as applicable, would be equivalent to compliance with the requirements of this Regulation. 2. An administrator or other supervised entity that makes an application for endorsement as referred to in paragraph 1 shall provide all information necessary to satisfy the competent authority that, at the time of application, all the conditions referred to in that paragraph are fulfilled. 3. Within 90 working days of receipt of the application for endorsement referred to in paragraph 1, the relevant competent authority shall examine the application and adopt a decision either to authorise the endorsement or to refuse it. An endorsed benchmark or an endorsed family of benchmarks shall be notified by the competent authority to ESMA. 4. An endorsed benchmark or an endorsed family of benchmarks shall be considered to be a benchmark or family of benchmarks provided by the endorsing administrator or other supervised entity. The endorsing administrator or other supervised entity shall not use the endorsement with the intention of avoiding the requirements of this Regulation. 5. An administrator or other supervised entity that has endorsed a benchmark or a family of benchmarks provided in a third country shall remain fully responsible for such a benchmark or family of benchmarks and for compliance with the obligations under this Regulation. 6. Where the competent authority of the endorsing administrator or other supervised entity has well-founded reasons to consider that the conditions laid down under paragraph 1 of this Article are no longer fulfilled, it shall have the power to require the endorsing administrator or other supervised entity to cease the endorsement and shall inform ESMA thereof. Article 28 shall apply in case of cessation of the endorsement. 7. The Commission shall be empowered to adopt delegated acts in accordance with Article 49 concerning measures to determine the conditions under which the relevant competent authorities may assess whether there is an objective reason for the provision of a benchmark or family of benchmarks in a third country and their endorsement for their use in the Union. The Commission shall take into account elements such as the specificities of the underlying market or economic reality the benchmark intends to measure, the need for proximity of the provision of the benchmark to such market or economic reality, the need for proximity of the provision of the benchmark to contributors, the material availability of input data due to different time zones, and specific skills required in the provision of the benchmark. TITLE VI AUTHORISATION, REGISTRATION AND SUPERVISION OF ADMINISTRATORS CHAPTER 1 Authorisation and registration Article 34 Authorisation and registration of an administrator 1. A natural or legal person located in the Union that intends to act as an administrator shall apply to the competent authority designated under Article 40 of the Member State in which that person is located in order to receive: (a) authorisation if it provides or intends to provide indices which are used or intended to be used as benchmarks within the meaning of this Regulation; (b) registration if it is a supervised entity, other than an administrator, that provides or intends to provide indices which are used or intended to be used as benchmarks within the meaning of this Regulation, on condition that the activity of provision of a benchmark is not prevented by the sectoral discipline applying to the supervised entity and that none of the indices provided would qualify as a critical benchmark; or (c) registration if it provides or intends to provide only indices which would qualify as non-significant benchmarks. 2. An authorised or registered administrator shall comply at all times with the conditions laid down in this Regulation and shall notify the competent authority of any material changes thereof. 3. The application referred to in paragraph 1 shall be made within 30 working days of any agreement entered into by a supervised entity to use an index provided by the applicant as a reference to a financial instrument or financial contract or to measure the performance of an investment fund. 4. The applicant shall provide all information necessary to satisfy the competent authority that the applicant has established, at the time of authorisation or registration, all the necessary arrangements to meet the requirements laid down in this Regulation. 5. Within 15 working days of receipt of the application, the relevant competent authority shall assess whether the application is complete and shall notify the applicant accordingly. If the application is incomplete, the applicant shall submit the additional information required by the relevant competent authority. The time limit referred to in this paragraph shall apply from the date on which such additional information is provided by the applicant. 6. The relevant competent authority shall: (a) examine the application for authorisation and adopt a decision to authorise or refuse to authorise the applicant within four months of receipt of a complete application; (b) examine the application for registration and adopt a decision to register or refuse to register the applicant within 45 working days of receipt of a complete application. Within five working days of the adoption of a decision referred to in the first subparagraph, the competent authority shall notify it to the applicant. Where the competent authority refuses to authorise or to register the applicant, it shall give reasons for its decision. 7. The competent authority shall notify ESMA of any decision to authorise or to register an applicant within five working days of the date of adoption of said decision. 8. ESMA shall develop draft regulatory technical standards to specify further the information to be provided in the application for authorisation and in the application for registration, taking into account that authorisation and registration are distinct processes where authorisation requires a more extensive assessment of the administrator's application, the principle of proportionality, the nature of the supervised entities applying for registration under point (b) of paragraph 1 and the costs to the applicants and competent authorities. ESMA shall submit those draft regulatory technical standards to the Commission by 1 April 2017. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 35 Withdrawal or suspension of authorisation or registration 1. A competent authority may withdraw or suspend the authorisation or registration of an administrator where the administrator: (a) expressly renounces the authorisation or registration or has provided no benchmarks for the preceding 12 months; (b) has obtained the authorisation or registration, or has endorsed a benchmark, by making false statements or by any other irregular means; (c) no longer meets the conditions under which it was authorised or registered; or (d) has seriously or repeatedly infringed the provisions of this Regulation. 2. The competent authority shall notify ESMA of its decision within five working days of the adoption of said decision. ESMA shall promptly update the register provided for in Article 36. 3. Following the adoption of a decision to suspend the authorisation or registration of an administrator, and where cessation of the benchmark would result in a force majeure event, or frustrate or otherwise breach the terms of any financial contract or financial instrument, or the rules of any investment fund, which references that benchmark, as specified in the delegated act adopted pursuant to Article 51(6), the provision of the benchmark in question may be permitted by the relevant competent authority of the Member State where the administrator is located until the decision of suspension has been withdrawn. During that period of time, the use of such benchmark by supervised entities shall be permitted only for financial contracts, financial instruments and investment funds that already reference the benchmark. 4. Following the adoption of a decision to withdraw the authorisation or registration of an administrator, Article 28(2) shall apply. Article 36 Register of administrators and benchmarks 1. ESMA shall establish and maintain a public register that contains the following information: (a) the identities of the administrators authorised or registered pursuant to Article 34 and the competent authorities responsible for the supervision thereof; (b) the identities of administrators that comply with the conditions laid down in Article 30(1), the list of benchmarks referred to in point (c) of Article 30(1) and the third country competent authorities responsible for the supervision thereof; (c) the identities of the administrators that acquired recognition in accordance with Article 32, the list of benchmarks referred to in Article 32(7) and, where applicable, the third country competent authorities responsible for the supervision thereof; (d) the benchmarks that are endorsed in accordance with the procedure laid down in Article 33, the identities of their administrators, and the identities of the endorsing administrators or endorsing supervised entities. 2. The register referred to in paragraph 1 shall be publicly accessible on the website of ESMA and shall be updated promptly, as necessary. CHAPTER 2 Supervisory cooperation Article 37 Delegation of tasks between competent authorities 1. In accordance with Article 28 of Regulation (EU) No 1095/2010, a competent authority may delegate its tasks under this Regulation to the competent authority of another Member State with its prior consent. The competent authorities shall notify ESMA of any proposed delegation 60 days prior to such delegation taking effect. 2. A competent authority may delegate some of its tasks under this Regulation to ESMA, subject to the agreement of ESMA. 3. ESMA shall notify the Member States of a proposed delegation within seven days. ESMA shall publish details of any agreed delegation within five working days of notification. Article 38 Disclosure of information from another Member State A competent authority may disclose information received from another competent authority only if: (a) it has obtained the written agreement of that competent authority and the information is disclosed only for the purposes for which that competent authority gave its agreement; or (b) such disclosure is necessary for legal proceedings. Article 39 Cooperation on on-site inspections and investigations 1. A competent authority may request the assistance of another competent authority with regard to on-site inspections or investigations. The competent authority receiving the request shall cooperate to the extent possible and appropriate. 2. A competent authority making a request referred to in paragraph 1 shall inform ESMA thereof. In the event of an investigation or inspection with cross-border effect, the competent authorities may request ESMA to coordinate the on-site inspection or investigation. 3. Where a competent authority receives a request from another competent authority to carry out an on-site inspection or an investigation, it may: (a) carry out the on-site inspection or investigation itself; (b) allow the competent authority which submitted the request to participate in the on-site inspection or investigation; (c) appoint auditors or experts to support or carry out the on-site inspection or investigation. CHAPTER 3 Role of competent authorities Article 40 Competent authorities 1. For administrators and supervised entities, each Member State shall designate the relevant competent authority responsible for carrying out the duties under this Regulation and shall inform the Commission and ESMA thereof. 2. Where a Member State designates more than one competent authority, it shall clearly determine their respective roles and shall designate a single authority to be responsible for coordinating cooperation and the exchange of information with the Commission, ESMA and other Member States' competent authorities. 3. ESMA shall publish on its website a list of the competent authorities designated in accordance with paragraphs 1 and 2. Article 41 Powers of competent authorities 1. In order to fulfil their duties under this Regulation, competent authorities shall have, in conformity with national law, at least the following supervisory and investigatory powers: (a) access to any document and other data in any form, and to receive or take a copy thereof; (b) require or demand information from any person involved in the provision of, and contribution to, a benchmark, including any service provider to which functions, services or activities in the provision of a benchmark have been outsourced as provided for in Article 10, as well as their principals, and if necessary, summon and question any such person with a view to obtaining information; (c) request, in relation to commodity benchmarks, information from contributors on related spot markets according, where applicable, to standardised formats and reports on transactions, and direct access to traders' systems; (d) carry out on-site inspections or investigations, at sites other than the private residences of natural persons; (e) enter premises of legal persons, without prejudice to Regulation (EU) No 596/2014, in order to seize documents and other data in any form, where a reasonable suspicion exists that documents and other data related to the subject-matter of the inspection or investigation may be relevant to prove a breach of this Regulation. Where prior authorisation is needed from the judicial authority of the Member State concerned, in accordance with national law, such power shall only be used after having obtained that prior authorisation; (f) require existing recordings of telephone conversations, electronic communications or other data traffic records held by supervised entities; (g) request the freezing or sequestration of assets or both; (h) require temporary cessation of any practice that the competent authority considers contrary to this Regulation; (i) impose a temporary prohibition on the exercise of professional activity; (j) take all necessary measures to ensure that the public is correctly informed about the provision of a benchmark, including by requiring the relevant administrator or a person that has published or disseminated the benchmark or both to publish a corrective statement about past contributions to or figures of the benchmark. 2. Competent authorities shall exercise their functions and powers referred to in paragraph 1 of this Article and the powers to impose sanctions referred to in Article 42, in accordance with their national legal frameworks, in any of the following ways: (a) directly; (b) in collaboration with other authorities or with market undertakings; (c) under their responsibility by delegation to such authorities or to market undertakings; (d) by application to the competent judicial authorities. For the exercise of those powers, competent authorities shall have in place adequate and effective safeguards in regard to the right of defence and fundamental rights. 3. Member States shall ensure that appropriate measures are in place so that competent authorities have all the supervisory and investigatory powers that are necessary to fulfil their duties. 4. An administrator or any other supervised entity making information available to a competent authority in accordance with paragraph 1 shall not be considered to be in breach of any restriction on disclosure of information posed by any contractual, legislative, regulatory or administrative provision. Article 42 Administrative sanctions and other administrative measures 1. Without prejudice to the supervisory powers of competent authorities in accordance with Article 41, and the right of Member States to provide for and impose criminal sanctions, Member States shall, in conformity with national law, provide for competent authorities to have the power to impose appropriate administrative sanctions and other administrative measures in relation to at least the following infringements: (a) any infringement of Articles 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 21, 23, 24, 25, 26, 27, 28, 29 and 34 where they apply; and (b) any failure to cooperate or comply in an investigation or with an inspection or request covered by Article 41. Those administrative sanctions and other administrative measures shall be effective, proportionate and dissuasive. 2. In the event of an infringement referred to in paragraph 1, Member States shall, in conformity with national law, confer on competent authorities the power to impose at least the following administrative sanctions and other administrative measures: (a) an order requiring the administrator or supervised entity responsible for the infringement to cease the conduct and to desist from repeating that conduct; (b) the disgorgement of the profits gained or losses avoided because of the infringement where those can be determined; (c) a public warning which indicates the administrator or supervised entity responsible and the nature of the infringement; (d) withdrawal or suspension of the authorisation or the registration of an administrator; (e) a temporary ban prohibiting any natural person, who is held responsible for such infringement, from exercising management functions in administrators or supervised contributors; (f) the imposition of maximum administrative pecuniary sanctions of at least three times the amount of the profits gained or losses avoided because of the infringement where those can be determined; (g) in respect of a natural person, maximum administrative pecuniary sanctions of at least: (i) for infringements of Articles 4, 5, 6, 7, 8, 9, 10, points (a), (b), (c) and (e) of Article 11(1), Article 11(2) and (3), and Articles 12, 13,14, 15, 16, 21, 23, 24, 25, 26, 27, 28, 29 and 34, EUR 500 000 or in the Member States whose official currency is not the euro, the corresponding value in the national currency on 30 June 2016; or (ii) for infringements of point (d) of Article 11(1) or of Article 11(4), EUR 100 000 or in the Member States whose official currency is not the euro, the corresponding value in the national currency on 30 June 2016; (h) in respect of a legal person, maximum administrative pecuniary sanctions of at least: (i) for infringements of Articles 4, 5, 6, 7, 8, 9, 10, points (a), (b), (c) and (e) of Article 11(1), Article 11(2) and (3), and Articles 12, 13,14, 15, 16, 21, 23, 24, 25, 26, 27, 28, 29 and 34, either EUR 1 000 000 or, in the Member States whose official currency is not the euro, the corresponding value in the national currency on 30 June 2016, or 10 % of its total annual turnover according to the last available accounts approved by the management body, whichever is the higher; or (ii) for infringements of point (d) of Article 11(1) or of Article 11(4), either EUR 250 000 or, in the Member States whose official currency is not the euro, the corresponding value in the national currency on 30 June 2016, or 2 % of its total annual turnover according to the last available accounts approved by the management body, whichever is the higher. For the purposes of point (h)(i) and (ii), where the legal person is a parent undertaking or a subsidiary of a parent undertaking which has to prepare consolidated financial accounts in accordance with Directive 2013/34/EU of the European Parliament and of the Council (26), the relevant total annual turnover shall be the total annual turnover or the corresponding type of income in accordance with Council Directive 86/635/EEC (27) for banks and Council Directive 91/674/EEC (28) for insurance companies according to the last available consolidated accounts approved by the management body of the ultimate parent undertaking or if the person is an association, 10 % of the aggregate turnovers of its members. 3. By 1 January 2018, Member States shall notify the rules regarding paragraphs 1 and 2 to the Commission and ESMA. Member States may decide not to lay down rules for administrative sanctions as provided for in paragraph 1 where the infringements referred to in that paragraph are subject to criminal sanctions under their national law. In that case, Member States shall communicate to the Commission and ESMA the relevant criminal law provisions along with the notification referred to in the first subparagraph of this paragraph. They shall notify the Commission and ESMA without delay of any subsequent amendment thereto. 4. Member States may provide competent authorities under national law to have other powers to impose sanctions in addition to those referred to in paragraph 1 and may provide for higher levels of sanctions than those established in paragraph 2. Article 43 Exercise of supervisory powers and imposition of sanctions 1. Member States shall ensure that, when determining the type and level of administrative sanctions and other administrative measures, competent authorities take into account all relevant circumstances, including where appropriate: (a) the gravity and duration of the infringement; (b) the criticality of the benchmark to financial stability and the real economy; (c) the degree of responsibility of the responsible person; (d) the financial strength of the responsible person, as indicated, in particular, by the total annual turnover of the responsible legal person or the annual income of the responsible natural person; (e) the level of the profits gained or losses avoided by the responsible person, insofar as they can be determined; (f) the level of cooperation of the responsible person with the competent authority, without prejudice to the need to ensure disgorgement of profits gained or losses avoided by that person; (g) previous infringements by the person concerned; (h) measures taken, after the infringement, by a responsible person to prevent the repetition of the infringement. 2. In the exercise of their powers to impose administrative sanctions and other administrative measures under Article 42, competent authorities shall cooperate closely to ensure that the supervisory and investigative powers and administrative sanctions and other administrative measures produce the desired results of this Regulation. They shall also coordinate their action in order to avoid possible duplication and overlap when applying supervisory and investigative powers and administrative sanctions, including pecuniary sanctions, and other administrative measures to cross-border cases. Article 44 Obligation to cooperate 1. Where Member States have chosen, in accordance with Article 42, to lay down criminal sanctions for infringements of the provisions referred to in that Article, they shall ensure that appropriate measures are in place so that competent authorities have all the necessary powers to liaise with judicial authorities within their jurisdiction to receive specific information relating to criminal investigations or proceedings commenced for possible infringements of this Regulation. Those competent authorities shall provide that information to other competent authorities and ESMA, in order to fulfil their obligation to cooperate with each other and ESMA for the purposes of this Regulation. 2. Competent authorities shall provide assistance to competent authorities of other Member States. In particular, they shall exchange information and cooperate in any investigation or supervisory activities. Competent authorities may also cooperate with competent authorities of other Member States with respect to facilitating the recovery of pecuniary sanctions. Article 45 Publication of decisions 1. Subject to paragraph 2, a competent authority shall publish any decision imposing an administrative sanction or other administrative measure in relation to infringements of this Regulation on its official website immediately after the person subject to that decision has been informed of that decision. Such publication shall include at least information on the type and nature of the infringement and the identity of the persons subject to the decision. The first subparagraph does not apply to decisions imposing measures that are of an investigatory nature. 2. Where a competent authority considers that the publication of the identity of the legal person or of the personal data of a natural person, would be disproportionate following a case-by-case assessment conducted on the proportionality of the publication of such data, or where such publication would jeopardise the stability of financial markets or an on-going investigation, it shall do any of the following: (a) defer publication of the decision until such time as the reasons for that deferral cease to exist; (b) publish the decision on an anonymous basis in accordance with national law where such anonymous publication ensures an effective protection of the personal data concerned; (c) not publish the decision at all in the event that the competent authority is of the opinion that publication in accordance with point (a) or (b) will be insufficient to ensure: (i) that the stability of financial markets is not jeopardised; or (ii) the proportionality of the publication of such decisions with regard to measures which are deemed to be of a minor nature. Where a competent authority decides to publish a decision on an anonymous basis as referred to in point (b) of the first subparagraph, it may postpone the publication of the relevant data for a reasonable period of time where it is foreseeable that the reasons for anonymous publication shall cease to exist during that period. 3. Where the decision is subject to an appeal before a national judicial, administrative or other authority, the competent authority shall also publish, immediately, on its official website such information and any subsequent information on the outcome of such appeal. Any decision annulling a previous decision to impose a sanction or a measure shall also be published. 4. The competent authority shall ensure that any decision that is published in accordance with this Article shall remain accessible on its official website for a period of at least five years after its publication. Personal data contained in the publication shall only be kept on the official website of the competent authority for the period which is necessary in accordance with the applicable data protection rules. 5. Member States shall annually provide ESMA with aggregated information regarding all administrative sanctions and other administrative measures imposed pursuant to Article 42. That obligation does not apply to measures of an investigatory nature. ESMA shall publish that information in an annual report. Where Member States have chosen, in accordance with Article 42, to lay down criminal sanctions for infringements of the provisions referred to in that Article, their competent authorities shall annually provide ESMA with anonymised and aggregated data regarding all criminal investigations undertaken and criminal sanctions imposed. ESMA shall publish data on criminal sanctions imposed in an annual report. Article 46 Colleges 1. Within 30 working days from the inclusion of a benchmark referred to in points (a) and (c) of Article 20(1) in the list of critical benchmarks, with the exception of benchmarks where the majority of contributors are non-supervised entities, the competent authority shall establish a college. 2. The college shall comprise the competent authority of the administrator, ESMA, and the competent authorities of supervised contributors. 3. Competent authorities of other Member States shall have the right to be members of the college where, if the critical benchmark in question were to cease to be provided, it would have a significant adverse impact on the market integrity, financial stability, consumers, real economy, or financing of households and businesses of those Member States. Where a competent authority intends to become a member of a college, it shall submit a request to the competent authority of the administrator containing evidence that the requirements of the first subparagraph of this paragraph are fulfilled. The relevant competent authority of the administrator shall consider the request and notify the requesting authority within 20 working days of receipt of the request whether or not it considers those requirements to be fulfilled. Where it considers those requirements not to be fulfilled, the requesting authority may refer the matter to ESMA in accordance with paragraph 9. 4. ESMA shall contribute to promoting and monitoring the efficient, effective and consistent functioning of colleges referred to in this Article in accordance with Article 21 of Regulation (EU) No 1095/2010. To that end, ESMA shall participate as appropriate and shall be considered to be a competent authority for that purpose. Where ESMA acts in accordance with Article 17(6) of Regulation (EU) No 1095/2010 regarding a critical benchmark, it shall ensure appropriate exchange of information and cooperation with the other members of the college. 5. The competent authority of an administrator shall chair the meetings of the college, coordinate the actions of the college and ensure efficient exchange of information among members of the college. Where an administrator provides more than one critical benchmark, the competent authority of that administrator may establish a single college in respect of all the benchmarks provided by that administrator. 6. The competent authority of an administrator shall establish written arrangements within the framework of the college regarding the following matters: (a) the information to be exchanged between competent authorities; (b) the decision-making process between the competent authorities and the time frame within which each decision has to be taken; (c) the cases in which the competent authorities must consult each other; (d) the cooperation to be provided under Article 23(7) and (8). 7. The competent authority of an administrator shall give due consideration to any advice provided by ESMA concerning the written arrangements under paragraph 6 before agreeing their final text. The written arrangements shall be set out in a single document containing full reasons for any significant deviation from the advice of ESMA. The competent authority of the administrator shall transmit the written arrangements to the members of the college and to ESMA. 8. Before taking any measures referred to in Article 23(6), (7) and (9), and Articles 34, 35 and 42, the competent authority of an administrator shall consult the members of the college. The members of the college shall do everything reasonable within their power to reach an agreement within the time frame specified in the written arrangements referred to in paragraph 6 of this Article. Any decision of the competent authority of the administrator to take such measures shall take into account the impact on the other Member States concerned, in particular the potential impact on the stability of their financial systems. With regard to the decision to withdraw the authorisation or registration of an administrator in accordance with Article 35, whenever the cessation of a benchmark would result in a force majeure event, frustrate or otherwise breach the terms of any financial contract or financial instrument, or the rules of any investment fund, which references that benchmark in the Union, within the meaning specified by the Commission in any delegated act adopted pursuant to Article 51(6), the competent authorities within the college shall consider whether to adopt measures to mitigate the effects referred to in this paragraph, including: (a) a change to the code of conduct referred to in Article 15, the methodology or other rules of the benchmark; (b) a transitional period, during which the procedures envisaged under Article 28(2) shall apply. 9. In the absence of agreement between the members of a college, competent authorities may refer to ESMA any of the following situations: (a) where a competent authority has not communicated essential information; (b) where, following a request made under paragraph 3, the competent authority of the administrator has notified the requesting authority that the requirements of that paragraph are not fulfilled or where it has not acted upon such request within a reasonable time; (c) where the competent authorities have failed to reach an agreement on the matters set out in paragraph 6; (d) where there is a disagreement concerning the measures to be taken in accordance with Articles 34, 35 and 42; (e) where there is a disagreement concerning the measures to be taken in accordance with Article 23(6); (f) where there is a disagreement concerning the measures to be taken in accordance with the third subparagraph of paragraph 8 of this Article. 10. In the situations referred to in points (a), (b), (c), (d) and (f) of paragraph 9, if the issue is not settled within 30 days after referral to ESMA, the competent authority of an administrator shall take the final decision and provide a detailed explanation of its decision in writing to the competent authorities referred to in that paragraph and to ESMA. The period of time referred to in point (a) of Article 34(6) shall be suspended from the date of referral to ESMA until such time as a decision is taken in accordance with the first subparagraph of this paragraph. Where ESMA considers that the competent authority of the administrator has taken any measures referred to in paragraph 8 of this Article which may not be in conformity with Union law it shall act in accordance with Article 17 of Regulation (EU) No 1095/2010. 11. In the situation referred to in point (e) of paragraph 9 of this Article, and without prejudice to Article 258 TFEU, ESMA may act in accordance with the powers conferred on it under Article 19 of Regulation (EU) No 1095/2010. The power of the competent authority of an administrator under Article 23(6) may be exercised until such time as ESMA publishes its decision. Article 47 Cooperation with ESMA 1. The competent authorities shall cooperate with ESMA for the purposes of this Regulation, in accordance with Regulation (EU) No 1095/2010. 2. The competent authorities shall, without delay, provide ESMA with all information necessary to carry out its duties, in accordance with Article 35 of Regulation (EU) No 1095/2010. 3. ESMA shall develop draft implementing technical standards to determine the procedures and forms for exchange of information as referred to in paragraph 2. ESMA shall submit the draft implementing technical standards referred to in the first subparagraph to the Commission by 1 April 2017. Power is conferred to the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Article 48 Professional secrecy 1. Any confidential information received, exchanged or transmitted pursuant to this Regulation shall be subject to the conditions of professional secrecy laid down in paragraph 2. 2. The obligation of professional secrecy applies to all persons who work or who have worked for the competent authority or for any authority or market undertaking or natural or legal person to whom the competent authority has delegated its powers, including auditors and experts contracted by the competent authority. 3. Information covered by professional secrecy may not be disclosed to any other person or authority except by virtue of provisions laid down by Union or national law. 4. All information exchanged between the competent authorities under this Regulation that concerns business or operational conditions and other economic or personal affairs shall be considered confidential and shall be subject to the requirements of professional secrecy, except where the competent authority states at the time of communication that such information may be disclosed or where such disclosure is necessary for legal proceedings. TITLE VII DELEGATED AND IMPLEMENTING ACTS Article 49 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 3(2), 20(6), 24(2), 33(7), 51(6) and 54(3) shall be conferred on the Commission for an indeterminate period of time from 30 June 2016. 3. The delegation of power referred to in Articles 3(2), 20(6), 24(2), 33(7), 51(6) and 54(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 3(2), 20(6), 24(2), 33(7), 51(6) and 54(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 50 Committee procedure 1. The Commission shall be assisted by the European Securities Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply, having regard to the provisions of Article 8 thereof. TITLE VIII TRANSITIONAL AND FINAL PROVISIONS Article 51 Transitional provisions 1. An index provider providing a benchmark on 30 June 2016 shall apply for authorisation or registration in accordance with Article 34 by 1 January 2020. 2. By 1 January 2020, the competent authority of the Member State where an index provider applying for authorisation in accordance with Article 34 is located shall have the power to decide to register that index provider as an administrator even if it is not a supervised entity, under the following conditions: (a) the index provider does not provide a critical benchmark; (b) the competent authority is aware, on a reasonable basis, that the index or indices provided by the index provider are not widely used, within the meaning of this Regulation, in the Member State where the index provider is located as well as in other Member States. The competent authority shall notify ESMA of its decision adopted in accordance with the first subparagraph. The competent authority shall keep evidence of the reasons for its decision adopted in accordance with the first subparagraph, in such a form that it is possible to fully understand the evaluations of the competent authority that the index or indices provided by the index provider are not widely used, including any market data, judgement or other information, as well as information received from the index provider. 3. An index provider may continue to provide an existing benchmark which may be used by supervised entities until 1 January 2020 or, where the index provider submits an application for authorisation or registration in accordance with paragraph 1, unless and until such authorisation or registration is refused. 4. Where an existing benchmark does not meet the requirements of this Regulation, but ceasing or changing that benchmark to fulfil the requirements of this Regulation would result in a force majeure event, frustrate or otherwise breach the terms of any financial contract or financial instrument or the rules of any investment fund, which references that benchmark, the use of the benchmark shall be permitted by the competent authority of the Member State where the index provider is located. No financial instruments, financial contracts, or measurements of the performance of an investment fund shall add a reference to such an existing benchmark after 1 January 2020. 5. Unless the Commission has adopted an equivalence decision as referred to in Article 30(2) or (3) or unless an administrator has been recognised pursuant to Article 32, or a benchmark has been endorsed pursuant to Article 33, the use in the Union by supervised entities of a benchmark provided by an administrator located in a third country where the benchmark is already used in the Union as a reference for financial instruments, financial contracts, or for measuring the performance of an investment fund, shall be permitted only for such financial instruments, financial contracts and measurements of the performance of an investment fund that already reference the benchmark in the Union on, or which add a reference to such benchmark prior to, 1 January 2020. 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 49 concerning measures to determine the conditions on which the relevant competent authority may assess whether the cessation or the changing of an existing benchmark to conform with the requirements of this Regulation could reasonably result in a force majeure event, frustrate or otherwise breach the terms of any financial contract or financial instrument or the rules of any investment fund which references such benchmark. Article 52 Deadline for updating the prospectuses and key information documents Article 29(2) is without prejudice to outstanding prospectuses approved under Directive 2003/71/EC prior to 1 January 2018. For prospectuses approved prior to 1 January 2018 under Directive 2009/65/EC, the underlying documents shall be updated at the first occasion or at the latest within 12 months after that date. Article 53 ESMA reviews 1. ESMA shall seek to build a common European supervisory culture and consistent supervisory practices and ensure consistent approaches among competent authorities in relation to the application of Articles 32 and 33. To that end, the recognitions granted in accordance with Article 32 and the endorsements authorised in accordance with Article 33 shall be reviewed by ESMA every two years. ESMA shall issue an opinion to each competent authority that has recognised a third country administrator or endorsed a third country benchmark assessing how that competent authority applies the relevant requirements of Articles 32 and 33 respectively and the requirements of any relevant delegated act and regulatory or implementing technical standard based on this Regulation. 2. ESMA shall have the power to require the documented evidence from a competent authority for any of the decisions adopted in accordance with the first subparagraph of Article 51(2), Article 24(1) and Article 25(2). Article 54 Review 1. By 1 January 2020, the Commission shall review and submit a report to the European Parliament and to the Council on this Regulation and in particular on: (a) the functioning and effectiveness of the critical benchmark, mandatory administration and mandatory contribution regime under Articles 20, 21 and 23 and the definition of a critical benchmark in point (25) of Article 3(1); (b) the effectiveness of the authorisation, registration and supervision regime of administrators under Title VI and the colleges under Article 46 and the appropriateness of supervision of certain benchmarks by a Union body; (c) the functioning and effectiveness of Article 19(2), in particular the scope of its application. 2. The Commission shall review the evolution of international principles applicable to benchmarks and of legal frameworks and supervisory practices in third countries concerning the provision of benchmarks and report to the European Parliament and to the Council every five years after 1 January 2018. That report shall assess in particular whether there is a need to amend this Regulation and shall be accompanied by a legislative proposal, if appropriate. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 49 in order to extend the 42-month period referred to in Article 51(2) by 24 months, if the report referred to in point (b) of paragraph 1 of this Article provides evidence that the transitional registration regime under Article 51(2) is not detrimental to a common European supervisory culture and consistent supervisory practices and approaches among competent authorities. Article 55 Notification of benchmarks referenced and their administrators When a benchmark is referenced in a financial instrument covered by Article 4(1) of Regulation (EU) No 596/2014, the notifications under Article 4(1) of that Regulation shall include the name of the benchmark referenced and its administrator. Article 56 Amendments to Regulation (EU) No 596/2014 Regulation (EU) No 596/2014 is amended as follows: (1) Article 19 is amended as follows: (a) the following paragraph is inserted: \u20181a. The notification obligation referred to in paragraph 1 shall not apply to transactions in financial instruments linked to shares or to debt instruments of the issuer referred to in that paragraph where at the time of the transaction any of the following conditions is met: (a) the financial instrument is a unit or share in a collective investment undertaking in which the exposure to the issuer's shares or debt instruments does not exceed 20 % of the assets held by the collective investment undertaking; (b) the financial instrument provides exposure to a portfolio of assets in which the exposure to the issuer's shares or debt instruments does not exceed 20 % of the portfolio's assets; (c) the financial instrument is a unit or share in a collective investment undertaking or provides exposure to a portfolio of assets and the person discharging managerial responsibilities or person closely associated with such a person does not know, and could not know, the investment composition or exposure of such collective investment undertaking or portfolio of assets in relation to the issuer's shares or debt instruments, and furthermore there is no reason for that person to believe that the issuer's shares or debt instruments exceed the thresholds in point (a) or (b). If information regarding the investment composition of the collective investment undertaking or exposure to the portfolio of assets is available, then the person discharging managerial responsibility or person closely associated with such a person shall make all reasonable efforts to avail themselves of that information.\u2019; (b) in paragraph 7, the following subparagraph is inserted after the second subparagraph: \u2018For the purposes of point (b), transactions executed in shares or debt instruments of an issuer or derivatives or other financial instruments linked thereto by managers of a collective investment undertaking in which the person discharging managerial responsibilities or a person closely associated with them has invested do not need to be notified where the manager of the collective investment undertaking operates with full discretion, which excludes the manager receiving any instructions or suggestions on portfolio composition directly or indirectly from investors in that collective investment undertaking.\u2019. (2) Article 35 is amended as follows: (a) in paragraphs (2) and (3), the phrase \u2018and Article 19(13) and (14)\u2019 is replaced by \u2018, Article 19(13) and (14) and Article 38\u2019; (b) paragraph (5) is replaced by the following: \u20185. A delegated act adopted pursuant to Article 6(5) or (6), Article 12(5), the third subparagraph of Article 17(2), Article 17(3), Article 19(13) or (14) or Article 38, shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or the Council.\u2019. (3) In Article 38, the following paragraphs are added: \u2018By 3 July 2019, the Commission shall, after consulting ESMA, submit a report to the European Parliament and to the Council on the level of the thresholds set out in Article 19(1a)(a) and (b) in relation to managers' transactions where the issuer's shares or debt instruments form part of a collective investment undertaking or provide exposure to a portfolio of assets, with a view to assessing whether that level is appropriate or should be adjusted. The Commission shall be empowered to adopt delegated acts in accordance with Article 35 adjusting the thresholds in Article 19(1a)(a) and (b), if it determines in that report that those thresholds should be adjusted.\u2019. Article 57 Amendments to Directive 2008/48/EC Directive 2008/48/EC is amended as follows: (1) In Article 5(1), the following subparagraph is inserted after the second subparagraph: \u2018Where the credit agreement references a benchmark as defined in point 3 of Article 3(1) of Regulation (EU) 2016/1011 of the European Parliament and of the Council (*), the name of the benchmark and of its administrator and the potential implications on the consumer shall be provided by the creditor, or where applicable, by the credit intermediary, to the consumer in a separate document, which may be annexed to the Standard European Consumer Credit Information form. (*) Regulation (EU) 2016/1011, of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (OJ L 171, 29.6.2016, p. 1).\u2019.\" (2) In Article 27(1), the following subparagraph is inserted after the second subparagraph: \u2018By 1 July 2018 Member States shall adopt and publish the provisions necessary to comply with the third subparagraph of Article 5(1) and shall communicate them to the Commission. They shall apply those provisions from 1 July 2018.\u2019. Article 58 Amendments to Directive 2014/17/EU Directive 2014/17/EU is amended as follows: (1) In the second subparagraph of Article 13(1), the following point is inserted: \u2018(ea) where contracts that reference a benchmark as defined in point (3) of Article 3(1) of Regulation (EU) 2016/1011 of the European Parliament and of the Council (**) are available, the names of the benchmarks and of their administrators and the potential implications on the consumer; (**) Regulation (EU) 2016/1011, of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (OJ L 171, 29.6.2016, p. 1).\u2019;\" (2) In Article 42(2), the following subparagraph is inserted after the first subparagraph: \u2018By 1 July 2018, Member States shall adopt and publish the provisions necessary to comply with point (ea) of the second subparagraph of Article 13(1) and shall communicate them to the Commission. They shall apply those provisions from 1 July 2018.\u2019; (3) In Article 43(1), the following subparagraph is added: \u2018Point (ea) of the second subparagraph of Article 13(1) shall not apply to credit agreements existing before 1 July 2018.\u2019. Article 59 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2018. Notwithstanding the second paragraph of this Article, Articles 3(2), 5(5), 11(5), 13(3), 15(6), 16(5), Article 20 (excluding point (b) of paragraph (6)), Articles 21 and 23, Articles 25(8), 25(9), 26(5), 27(3), 30(5), 32(9), 33(7), 34(8), Article 46, and Articles 47(3) and 51(6) shall apply from 30 June 2016. Notwithstanding the second paragraph of this Article, Article 56 shall apply from 3 July 2016. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 8 June 2016. For the European Parliament The President M. SCHULZ For the Council The President A.G. KOENDERS (1) OJ C 113, 15.4.2014, p. 1. (2) OJ C 177, 11.6.2014, p. 42. (3) Position of the European Parliament of 28 April 2016 (not yet published in the Official Journal) and decision of the Council of 17 May 2016. (4) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349). (5) Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading and amending Directive 2001/34/EC (OJ L 345, 31.12.2003, p. 64). (6) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32). (7) Regulation (EU) No 1227/2011 of the European Parliament and of the Council of 25 October 2011 on wholesale energy market integrity and transparency (OJ L 326, 8.12.2011, p. 1). (8) Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66). (9) Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34). (10) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (11) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1). (12) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (13) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (14) OJ L 123, 12.5.2016, p. 1. (15) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (16) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (17) Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1). (18) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1). (19) Directive 2003/41/EC of the European Parliament and of the Council of 3 June 2003 on the activities and supervision of institutions for occupational retirement provision (OJ L 235, 23.9.2003, p. 10). (20) Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1). (21) Commission Regulation (EC) No 1287/2006 of 10 August 2006 implementing Directive 2004/39/EC of the European Parliament and of the Council as regards record-keeping obligations for investment firms, transaction reporting, market transparency, admission of financial instruments to trading, and defined terms for the purposes of that Directive (OJ L 241, 2.9.2006, p. 1). (22) Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84). (23) Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJ L 211, 14.8.2009, p. 55). (24) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94). (25) Commission Regulation (EU) No 1031/2010 of 12 November 2010 on the timing, administration and other aspects of auctioning of greenhouse gas emission allowances pursuant to Directive 2003/87/EC of the European Parliament and of the Council establishing a scheme for greenhouse gas emission allowances trading within the Community (OJ L 302, 18.11.2010, p. 1). (26) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19). (27) Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (OJ L 372, 31.12.1986, p. 1). (28) Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (OJ L 374, 31.12.1991, p. 7). ANNEX I INTEREST RATE BENCHMARKS Accurate and sufficient data 1. For the purposes of points (a) and (c) of Article 11(1), in general the priority of use of input data shall be as follows: (a) a contributor's transactions in the underlying market that a benchmark intends to measure or, if not sufficient, its transactions in related markets, such as: \u2014 the unsecured inter-bank deposit market, \u2014 other unsecured deposit markets, including certificates of deposit and commercial paper, and \u2014 other markets such as overnight index swaps, repurchase agreements, foreign exchange forwards, interest rate futures and options, provided that those transactions comply with the input data requirements in the code of conduct; (b) a contributor's observations of third party transactions in the markets described in point (a); (c) committed quotes; (d) indicative quotes or expert judgements. 2. For the purposes of point (a) of Article 11(1) and Article 11(4), input data may be adjusted. In particular, input data may be adjusted by application of the following criteria: (a) proximity of transactions to the time of provision of the input data and the impact of any market events between the time of the transactions and the time of provision of the input data; (b) interpolation or extrapolation from transactions data; (c) adjustments to reflect changes in the credit standing of the contributors and other market participants. Oversight function 3. The following requirements shall apply in substitution for the requirements of Article 5(4) and (5): (a) the administrator of an interest rate benchmark shall have in place an independent oversight committee. Details of the membership of that committee shall be made public, along with any declarations of any conflict of interest and the processes for election or nomination of its members; (b) the oversight committee shall hold no less than one meeting every four months and shall keep minutes of each such meeting; (c) the oversight committee shall operate with integrity and shall have all of the responsibilities provided for in Article 5(3). Auditing 4. The administrator of an interest rate benchmark shall appoint an independent external auditor to review and report on the administrator's compliance with the benchmark methodology and this Regulation. The external audit of the administrator shall be carried out for the first time six months after the introduction of the code of conduct and subsequently every two years. The oversight committee may require an external audit of a contributor to an interest rate benchmark if dissatisfied with any aspects of its conduct. Contributor systems and controls 5. The following requirements shall apply to contributors to interest rate benchmarks, in addition to the requirements set out in Article 16. Article 16(5) shall not apply. 6. Each contributor's submitter and the direct managers of that submitter shall acknowledge in writing that they have read the code of conduct and that they will comply with it. 7. A contributor's systems and controls shall include: (a) an outline of responsibilities within each firm, including internal reporting lines and accountability, including the location of submitters and managers and the names of relevant individuals and alternates; (b) internal procedures for sign-off of contributions of input data; (c) disciplinary procedures in respect of attempts to manipulate, or any failure to report, actual or attempted manipulation by parties external to the contribution process; (d) effective conflicts of interest management procedures and communication controls, both within contributors and between contributors and other third parties, to avoid any inappropriate external influence over those responsible for submitting rates. Submitters shall work in locations physically separated from interest rate derivatives traders; (e) effective procedures to prevent or control the exchange of information between persons engaged in activities involving a risk of conflict of interest where the exchange of that information may affect the benchmark data contributed; (f) rules to avoid collusion among contributors, and between contributors and the benchmark administrators; (g) measures to prevent, or limit, any person from exercising inappropriate influence over the way in which persons involved in the provision of input data carries out those activities; (h) the removal of any direct link between the remuneration of employees involved in the provision of input data and the remuneration of, or revenues generated by, persons engaged in another activity, where a conflict of interest may arise in relation to those activities; (i) controls to identify any reverse transaction subsequent to the provision of input data. 8. A contributor to an interest rate benchmark shall keep detailed records of: (a) all relevant aspects of contributions of input data; (b) the process governing input data determination and the sign-off of input data; (c) the names of submitters and their responsibilities; (d) any communications between the submitters and other persons, including internal and external traders and brokers, in relation to the determination or contribution of input data; (e) any interaction of submitters with the administrator or any calculation agent; (f) any queries regarding the input data and their outcome of those queries; (g) sensitivity reports for interest rate swap trading books and any other derivative trading book with a significant exposure to interest rate fixings in respect of input data. 9. Records shall be kept on a medium that allows the storage of information to be accessible for future reference with a documented audit trail. 10. The compliance function of the contributor to an interest rate benchmark shall report any findings, including reverse transactions, to management on a regular basis. 11. Input data and procedures shall be subject to regular internal reviews. 12. An external audit of the input data of a contributor to an interest rate benchmark, compliance with the code of conduct and the provisions of this Regulation shall be carried out for the first time six months after the introduction of the code of conduct, and subsequently every two years. ANNEX II COMMODITY BENCHMARKS Methodology 1. The administrator of a commodity benchmark shall formalise, document, and make public any methodology that the administrator uses for a benchmark calculation. At a minimum, such methodology shall contain and describe the following: (a) all criteria and procedures that are used to develop the benchmark, including how the administrator uses input data including the specific volume, concluded and reported transactions, bids, offers and any other market information in its assessment or assessment time periods or windows, why a specific reference unit is used, how the administrator collects such input data, the guidelines that control the exercise of judgement by assessors and any other information, such as assumptions, models or extrapolation from collected data that are considered in making an assessment; (b) procedures and practices that are designed to ensure consistency between its assessors in exercising their judgement; (c) the relative importance that shall be assigned to each criterion used in benchmark calculation, in particular the type of input data used and the type of criterion used to guide judgement so as to ensure the quality and integrity of the benchmark calculation; (d) criteria that identify the minimum amount of transaction data required for a particular benchmark calculation. If no such threshold is provided for, the reasons why a minimum threshold is not established shall be explained, including setting out the procedures to be used where no transaction data exist; (e) criteria that address the assessment periods where the submitted data fall below the methodology's recommended transaction data threshold or the requisite administrator's quality standards, including any alternative methods of assessment including theoretical estimation models. Those criteria shall explain the procedures to be used where no transaction data exist; (f) criteria for timeliness of contributions of input data and the means for such contributions of input data whether electronically, by telephone or otherwise; (g) criteria and procedures that address assessment periods where one or more contributors submit input data that constitute a significant proportion of the total input data for that benchmark. The administrator shall also define in those criteria and procedures what constitutes a significant proportion for each benchmark calculation; (h) criteria according to which transaction data may be excluded from a benchmark calculation. 2. The administrator of a commodity benchmark shall publish or make available the key elements of the methodology that the administrator uses for each commodity benchmark provided and published or, when applicable, for each family of benchmarks provided and published. 3. Along with the methodology referred to in paragraph 2, the administrator of a commodity benchmark shall also describe and publish all of the following: (a) the rationale for adopting a particular methodology, including any price adjustment techniques and a justification of why the time period or window within which input data is accepted is a reliable indicator of physical market values; (b) the procedure for internal review and approval of a given methodology, as well as the frequency of such review; (c) the procedure for external review of a given methodology, including the procedures to gain market acceptance of the methodology through consultation with users on important changes to their benchmark calculation processes. Changes to a methodology 4. The administrator of a commodity benchmark shall adopt and make public to users explicit procedures and the rationale of any proposed material change in its methodology. Those procedures shall be consistent with the overriding objective that an administrator must ensure the continued integrity of its benchmark calculations and implement changes for good order of the particular market to which such changes relate. Such procedures shall provide: (a) advance notice in a clear time frame that gives users sufficient opportunity to analyse and comment on the impact of such proposed changes, having regard to the administrator's calculation of the overall circumstances; (b) for users' comments, and the administrator's response to those comments, to be made accessible to all market users after any given consultation period, except where the commenter has requested confidentiality. 5. The administrator of a commodity benchmark shall regularly examine its methodologies for the purpose of ensuring that they reliably reflect the physical market under assessment and shall include a process for taking into account the views of relevant users. Quality and integrity of benchmark calculations 6. The administrator of a commodity benchmark shall: (a) specify the criteria that define the physical commodity that is the subject of a particular methodology; (b) give priority to input data in the following order, where consistent with its methodologies: (i) concluded and reported transactions; (ii) bids and offers; (iii) other information. If concluded and reported transactions are not given priority, the reasons should be explained, as required in point 7(b). (c) employ sufficient measures designed to use input data submitted and considered in a benchmark calculation which are bona fide, meaning that the parties submitting the input data have executed, or are prepared to execute, transactions generating such input data and the concluded transactions were executed at arms-length from each other and particular attention shall be paid to inter-affiliate transactions; (d) establish and employ procedures to identify anomalous or suspicious transaction data and keep records of decisions to exclude transaction data from the administrator's benchmark calculation process; (e) encourage contributors to submit all of their input data that falls within the administrator's criteria for that calculation. Administrators shall seek, so far as they are able and is reasonable, to ensure that input data submitted is representative of the contributors' actual concluded transactions; and (f) employ a system of appropriate measures to ensure that contributors comply with the administrator's applicable quality and integrity standards for input data. 7. The administrator of a commodity benchmark shall describe and publish for each calculation, to the extent reasonable without prejudicing due publication of the benchmark: (a) a concise explanation, sufficient to facilitate a benchmark subscriber's or competent authority's ability to understand how the calculation was developed including, at a minimum, the size and liquidity of the physical market being assessed (such as the number and volume of transactions submitted), the range and average volume and range and average of price, and indicative percentages of each type of input data that have been considered in a calculation; terms referring to the pricing methodology shall be included such as transaction-based, spread-based or interpolated or extrapolated; and (b) a concise explanation of the extent to which, and the basis upon which, any judgement including the exclusions of data which otherwise conformed to the requirements of the relevant methodology for that calculation, basing prices on spreads or interpolation, extrapolation, or weighting bids or offers higher than concluded transactions, if any, was used in any calculation. Integrity of the reporting process 8. The administrator of a commodity benchmark shall: (a) specify the criteria that define who may submit input data to the administrator; (b) have in place quality control procedures to evaluate the identity of a contributor and any submitter who reports input data and the authorisation of such submitter to report input data on behalf of a contributor; (c) specify the criteria applied to employees of a contributor who are permitted to submit input data to an administrator on behalf of a contributor; encourage contributors to submit transaction data from back office functions and seek corroborating data from other sources where transaction data is received directly from a trader; and (d) implement internal controls and written procedures to identify communications between contributors and assessors that attempt to influence a calculation for the benefit of any trading position (whether of the contributor, its employees or any third party), attempt to cause an assessor to violate the administrator's rules or guidelines or identify contributors that engage in a pattern of submitting anomalous or suspicious transaction data. Those procedures shall include, to the extent possible, provision for escalation of the inquiry by the administrator within the contributor's company. Controls shall include cross-checking market indicators to validate submitted information. Assessors 9. In relation to the role of an assessor, the administrator of a commodity benchmark shall: (a) adopt and have in place explicit internal rules and guidelines for selecting assessors, including their minimum level of training, experience and skills, as well as the process for periodic review of their competence; (b) have in place arrangements to ensure that calculations can be made on a consistent and regular basis; (c) maintain continuity and succession planning in respect of its assessors in order to ensure that calculations are made consistently and by employees who possess the relevant levels of expertise; and (d) establish internal control procedures to ensure the integrity and reliability of calculations. At a minimum, such internal controls and procedures shall require the ongoing supervision of assessors to ensure that the methodology was properly applied and procedures for internal sign-off by a supervisor prior to releasing prices for dissemination to the market. Audit trails 10. The administrator of a commodity benchmark shall have rules and procedures in place to document contemporaneously relevant information, including: (a) all input data; (b) the judgements that are made by assessors in reaching each benchmark calculation; (c) whether a calculation excluded a particular transaction which otherwise conformed to the requirements of the relevant methodology for that calculation, and the rationale for doing so; (d) the identity of each assessor and of any other person who submitted or otherwise generated any of the information in points (a), (b) or (c). 11. The administrator of a commodity benchmark shall have rules and procedures in place to ensure that an audit trail of relevant information is retained for at least five years in order to document the construction of its calculations. Conflicts of interest 12. The administrator of a commodity benchmark shall establish adequate policies and procedures for the identification, disclosure, management or mitigation and avoidance of any conflict of interest and the protection of integrity and independence of calculations. Those policies and procedures shall be reviewed and updated regularly and shall: (a) ensure that benchmark calculations are not influenced by the existence of, or potential for, a commercial or personal business relationship or interest between the administrator or its affiliates, its personnel, clients, any market participant or persons connected with them; (b) ensure that personal interests and business connections of the administrator's personnel are not permitted to compromise the administrator's functions, including outside employment, travel, and acceptance of entertainment, gifts and hospitality provided by the administrator's clients or other commodity market participants; (c) ensure, in respect of identified conflicts, appropriate segregation of functions within the administrator by way of supervision, compensation, systems access and information flows; (d) protect the confidentiality of information submitted to or produced by the administrator, subject to the disclosure obligations of the administrator; (e) prohibit managers, assessors and other employees of the administrator from contributing to a benchmark calculation by way of engaging in bids, offers and trades on either a personal basis or on behalf of market participants; and (f) effectively address any identified conflict of interest which may exist between the administrator's provision of a benchmark (including all employees who perform or otherwise participate in benchmark calculation responsibilities), and any other business of the administrator. 13. The administrator of a commodity benchmark shall ensure that its other business operations have in place appropriate procedures and mechanisms designed to minimise the likelihood that a conflict of interest will affect the integrity of benchmark calculations. 14. The administrator of a commodity benchmark shall ensure that it has in place segregated reporting lines amongst its managers, assessors and other employees and from the managers to the administrator's most senior level management and its board to ensure: (a) that the administrator satisfactorily implements the requirements of this Regulation; and (b) that responsibilities are clearly defined and do not conflict or cause a perception of conflict. 15. The administrator of a commodity benchmark shall disclose to its users as soon as it becomes aware of a conflict of interest arising from the ownership of the administrator. Complaints 16. The administrator of a commodity benchmark shall have in place and publish a complaints handling policy setting out procedures for receiving, investigating and retaining records concerning complaints made about an administrator's calculation process. Such complaint mechanisms shall ensure that: (a) subscribers of the benchmark may submit complaints on whether a specific benchmark calculation is representative of market value, proposed benchmark calculation changes, applications of methodology in relation to a specific benchmark calculation and other editorial decisions in relation to the benchmark calculation processes; (b) there is in place a target timetable for the handling of complaints; (c) formal complaints made against the administrator and its personnel are investigated by that administrator in a timely and fair manner; (d) the inquiry is conducted independently of any personnel who may be involved in the subject of the complaint; (e) the administrator aims to complete its investigation promptly; (f) the administrator advises the complainant and any other relevant parties of the outcome of the investigation in writing and within a reasonable period; (g) there is recourse to an independent third party appointed by the administrator. if a complainant is dissatisfied with the way a complaint has been handled by the relevant administrator or the administrator's decision in the situation no later than six months from the time of the original complaint; and (h) all documents relating to a complaint, including those submitted by the complainant as well as an administrator's own record, are retained for a minimum of five years. 17. Disputes as to daily pricing determinations, which are not formal complaints, shall be resolved by the administrator of a commodity benchmark with reference to its appropriate standard procedures. If a complaint results in a change in price, the details of that change in price shall be communicated to the market as soon as possible. External auditing 18. The administrator of a commodity benchmark shall appoint an independent external auditor with appropriate experience and capability to review and report on the administrator's adherence to its stated methodology criteria and with the requirements of this Regulation. Audits shall take place annually and be published three months after each audit is completed with further interim audits carried out as appropriate.", "summary": "Ensuring accuracy and integrity of benchmarks Ensuring accuracy and integrity of benchmarks SUMMARY OF: Regulation (EU) 2016/1011 on indices used as financial benchmarks WHAT IS THE AIM OF THE REGULATION? It sets common European Union (EU) standards to prevent manipulation of benchmarks* that could affect the price of financial instruments, or financial contracts such as loans or mortgages. KEY POINTS Administrators* responsible for the provision of financial benchmarks must: apply robust governance arrangements and clear organisational structures;identify, prevent or manage any potential conflicts of interest;ensure their staff have the necessary skills, knowledge and experience, and are effectively managed and supervised;maintain permanent and effective oversight of all aspects of the benchmarks under their responsibility;operate controls to ensure benchmarks comply with the legislation;have a system in place to record input data, phone or electronic communications and complaints received and investigated;subject any outsourcing to strict conditions;publish clear guidelines for different types of input data and the methodology used for calculating benchmarks;develop a code of conduct stipulating the responsibilities of contributors providing input data to the administrator. The regulation establishes three separate regimes, progressively increasing the level of regulation and supervision depending on a benchmark\u2019s importance: non-significant benchmarks do not fall into either of the two categories below and are subject to less onerous rules;significant benchmarks are used as a reference for financial instruments, financial contracts or investment funds with a total average value of at least \u20ac50 billion, or fulfil certain other criteria;critical benchmarks are used as a reference for financial instruments, financial contracts or investment funds with a total value of at least \u20ac500 billion, or fulfil certain other criteria. Specific arrangements exist for commodity benchmarks*, interest rate benchmarks and regulated data benchmarks*. Two types of EU climate benchmarks that are underpinned by a methodology linked to the commitments laid down in the Paris agreement were introduced into the regulation by amending Regulation (EU) 2019/2089. The regulation also lays down environmental, social and governance (ESG) disclosure requirements for all benchmarks, with the exception of interest rate and foreign exchange benchmarks. The European Securities and Markets Authority (ESMA) establishes and maintains a public register of all authorised or registered administrators. Various schemes exist to provide access to the EU market for financial benchmarks and administrators from outside the EU. EU Member States\u2019 competent authorities have the power to apply appropriate administrative sanctions and other measures for an infringement. The European Commission had to report on the system\u2019s operation to the European Parliament and the Council of the European Union by 1 January 2020. Amending Regulation (EU) 2021/168 lays down rules enabling the Commission to designate a statutory replacement benchmark where a critical benchmark or a non-EU country benchmark that is of particular relevance in the EU ceases to be provided. This aims to reduce legal uncertainty regarding existing contracts and avoid risks to financial stability, and was prompted by the fact that, from January 2022, the London interbank offered rate (LIBOR) interest rate benchmark will cease to be published. Delegated acts Delegated acts adopted by the Commission include: Delegated Regulation (EU) 2018/1637 with regard to technical standards in relation to the oversight function; Delegated Regulation (EU) 2018/1642 with regard to technical standards specifying further the criteria to be taken into account by competent authorities when assessing whether administrators of significant benchmarks should apply certain requirements; Delegated Regulation (EU) 2020/1816 as regards the explanation in the benchmark statement of how environmental, social and governance factors are reflected in each benchmark provided and published; Delegated Regulation (EU) 2020/1817 as regards the minimum content of the explanation on how environmental, social and governance factors are reflected in the benchmark methodology; Delegated Regulation (EU) 2020/1818 as regards minimum standards for EU climate transition benchmarks and EU Paris-aligned benchmarks; Delegated Regulation (EU) 2021/1348 with regard to technical standards specifying the criteria under which competent authorities may require changes to the compliance statement of non-significant benchmarks; Delegated Regulation (EU) 2021/1349 with regard to technical standards specifying the criteria for the competent authorities\u2019 compliance assessment regarding the mandatory administration of a critical benchmark; Delegated Regulation (EU) 2021/1350 with regard to technical standards specifying the requirements to ensure that an administrator\u2019s governance arrangements are sufficiently robust; Delegated Regulation (EU) 2021/1351 with regard to technical standards specifying the characteristics of the systems and controls for the identification and reporting of any conduct that may involve manipulation or attempted manipulation of a benchmark; and Delegated Regulation (EU) 2021/1352 with regard to technical standards specifying the conditions to ensure that the methodology for determining a benchmark complies with the quality requirements. FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) 2016/1011 has applied since 1 January 2018, except for certain articles which have already applied since 30 June 2016. These articles largely involve preparatory work, such as the development by ESMA of regulatory technical standards, but also the identification and supervision of critical benchmarks. The regime applicable to the use of non-EU benchmarks in the EU will start to apply as of 31 December 2023. Regulation (EU) 2021/168 has applied since 13 February 2021. BACKGROUND Benchmarks are used to price financial instruments and financial contracts or to measure the performance of investment funds. A well-known example of a benchmark is the euro interbank offered rate (Euribor), used for interbank interest rates. Benchmarks are also used for oil price assessments, stock market indexes and the level of personal mortgage payments. For more information, see: Benchmarks \u2014 Regulation (EU) 2016/1011 (European Commission)EU climate benchmarks and benchmarks\u2019 ESG disclosures (European Commission). KEY TERMS Benchmark. A figure which is made public and used to price payments under financial instruments or financial contracts, or to measure the performance of an investment fund. Administrator. An individual or company/organisation that has control over a benchmark. Commodity benchmark. A benchmark that measures the price of a commodity. Regulated data benchmark. Benchmarks determined from input data that is provided by regulated venues, energy exchanges and emission allowance auctions. MAIN DOCUMENT Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (OJ L 171, 29.6.2016, pp. 1\u201365). Successive amendments to Regulation (EU) 2016/1011 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2021/1352 of 6 May 2021 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council with regard to regulatory technical standards specifying the conditions to ensure that the methodology for determining a benchmark complies with the quality requirements (OJ L 291, 13.8.2021, pp. 16\u201319). Commission Delegated Regulation (EU) 2021/1351 of 6 May 2021 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council with regard to regulatory technical standards specifying the characteristics of the systems and controls for the identification and reporting of any conduct that may involve manipulation or attempted manipulation of a benchmark (OJ L 291, 13.8.2021, pp. 13\u201315). Commission Delegated Regulation (EU) 2021/1350 of 6 May 2021 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council with regard to regulatory technical standards specifying the requirements to ensure that an administrator\u2019s governance arrangements are sufficiently robust (OJ L 291, 13.8.2021, pp. 9\u201312). Commission Delegated Regulation (EU) 2021/1349 of 6 May 2021 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council with regard to regulatory technical standards specifying the criteria for the competent authorities\u2019 compliance assessment regarding the mandatory administration of a critical benchmark (OJ L 291, 13.8.2021, pp. 4\u20138). Commission Delegated Regulation (EU) 2021/1348 of 6 May 2021 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council with regard to regulatory technical standards specifying the criteria under which competent authorities may require changes to the compliance statement of non-significant benchmarks (OJ L 291, 13.8.2021, pp. 1\u20133). Commission Delegated Regulation (EU) 2020/1816 of 17 July 2020 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council as regards the explanation in the benchmark statement of how environmental, social and governance factors are reflected in each benchmark provided and published (OJ L 406, 3.12.2020, pp. 1\u201311). Commission Delegated Regulation (EU) 2020/1817 of 17 July 2020 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council as regards the minimum content of the explanation on how environmental, social and governance factors are reflected in the benchmark methodology (OJ L 406, 3.12.2020, pp. 12\u201316). Commission Delegated Regulation (EU) 2020/1818 of 17 July 2020 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council as regards minimum standards for EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks (OJ L 406, 3.12.2020, pp. 17\u201325). Commission Delegated Regulation (EU) 2018/1637 of 13 July 2018 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council with regard to regulatory technical standards for the procedures and characteristics of the oversight function (OJ L 274, 5.11.2018, pp. 1\u20135). Commission Delegated Regulation (EU) 2018/1642 of 13 July 2018 supplementing Regulation (EU) 2016/1011 of the European Parliament and of the Council with regard to regulatory technical standards specifying further the criteria to be taken into account by competent authorities when assessing whether administrators of significant benchmarks should apply certain requirements (OJ L 274, 5.11.2018, pp. 25\u201328). Commission Implementing Regulation (EU) 2016/1368 of 11 August 2016 establishing a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011 of the European Parliament and of the Council (OJ L 217, 12.8.2016, pp. 1\u20133). See consolidated version. Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, pp. 1\u201361). See consolidated version. Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, pp. 34\u201385). See consolidated version. Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, pp. 66\u201392). See consolidated version. last update 17.11.2021"}
{"article": "31.3.2016 EN Official Journal of the European Union L 81/99 REGULATION (EU) 2016/426 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Directive 2009/142/EC of the European Parliament and of the Council (3) lays down rules for the placing on the market and the putting into service of appliances burning gaseous fuels (\u2018appliances\u2019). (2) Directive 2009/142/EC is based on the \u2018new approach\u2019 principles, as set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (4). Thus, it sets out only the essential requirements applying to appliances, whereas technical details are adopted by the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (5). Conformity with the harmonised standards so set, the reference numbers of which are published in the Official Journal of the European Union, provides a presumption of conformity with the requirements of Directive 2009/142/EC. Experience has shown that those basic principles have worked well in that sector and should be maintained and even further promoted. (3) Experience acquired from the implementation of Directive 2009/142/EC has shown the need to modify some of its provisions in order to clarify and update them and thus ensure legal certainty as regards the definitions relating to its scope, the content of the Member States' communications of the types of gas and corresponding supply pressures used on their territory and certain essential requirements. (4) Since the scope, essential requirements and conformity assessment procedures have to be identical in all Member States, there is almost no flexibility in transposing a directive based on the new approach principles into national law. In order to simplify the regulatory framework, Directive 2009/142/EC should be replaced by a regulation, which is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for divergent transposition by Member States and thus ensures uniform implementation throughout the Union. (5) Decision No 768/2008/EC of the European Parliament and of the Council (6) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. In order to ensure consistency with other sectoral product legislation, Directive 2009/142/EC should be adapted to that Decision. (6) Regulation (EC) No 765/2008 of the European Parliament and of the Council (7) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. (7) The scope of this Regulation should reflect the scope of Directive 2009/142/EC. This Regulation should apply to domestic and non-domestic appliances intended for a number of specified applications and to fittings designed to be incorporated into such appliances. (8) This Regulation covers appliances and fittings which are new to the Union market when they are placed on the market; that is to say, they are either new appliances and fittings made by a manufacturer established in the Union or appliances and fittings, whether new or second-hand, imported from a third country. (9) Appliances possessing a historic or artistic value within the meaning of Article 36 of the Treaty on the Functioning of the European Union (TFEU) and not put into service, such as antique and other appliances serving exhibition or collection purposes, should not be considered as appliances covered by this Regulation. (10) This Regulation should apply to all forms of supply, including distance selling. (11) This Regulation should aim to ensure the functioning of the internal market of appliances and of fittings as regards gas safety risks and energy efficiency. (12) This Regulation should not apply in respect of aspects covered more specifically by other Union harmonisation legislation. This includes the measures adopted pursuant to Directive 2009/125/EC of the European Parliament and of the Council (8). (13) This Regulation should prevent Member States from imposing stricter requirements on health, safety and energy conservation which would prohibit, restrict or impede the making available on the market and the putting into service of appliances which comply with this Regulation. However, this should not affect the possibility for Member States, when implementing other Union acts, to impose requirements which affect the energy efficiency of products, including appliances, as long as such measures are compatible with the TFEU. (14) Directive 2009/28/EC of the European Parliament and of the Council (9) requires Member States to introduce in their building regulations and codes appropriate measures in order to increase the share of all kinds of energy from renewable sources in the building sector. Directive 2010/31/EU of the European Parliament and of the Council (10) requires Member States to set minimum energy performance requirements for buildings and building elements and system requirements in respect of the overall energy performance of the technical building systems which are installed in existing buildings. Directive 2012/27/EU of the European Parliament and of the Council (11) requires Member States to take sufficient measures to progressively reduce energy consumption in different areas, including in buildings. (15) This Regulation should not affect the obligation for Member States to adopt measures with respect to the promotion of the use of energy from renewable sources and to the energy efficiency of buildings, in accordance with Directives 2009/28/EC, 2010/31/EU and 2012/27/EU. It is consistent with the objectives of those Directives that national measures may in certain circumstances limit the installation of appliances which comply with the rational use of energy requirement of this Regulation, provided that such measures do not constitute an unjustifiable market barrier. (16) Member States should take the necessary steps to ensure that appliances are made available on the market and put into service only where they do not compromise the health and safety of persons, domestic animals or property, when normally used. (17) This Regulation should not affect the Member States' entitlement to lay down rules concerning commissioning or periodic inspections of appliances or other measures such as installer training or certification, in order to ensure the correct installation, use and maintenance of appliances, including precautionary safety measures. Those rules and measures are essential in preventing gas poisoning, including from carbon monoxide (CO), and the leakage of any substances harmful to health and safety. (18) This Regulation should not affect the Member States' entitlement to lay down requirements as they may deem necessary concerning installation aspects, space ventilation conditions and aspects relating to the safety of the building itself and its energy performance, provided that those requirements do not impose design requirements on appliances. (19) As this Regulation does not cover risks caused by appliances in the case of incorrect installation, maintenance or use, Member States should be encouraged to take measures to ensure that the public is made aware of the health and safety risks related to combustion products and the need for proper precautionary safety measures, inter alia in relation to emissions of carbon monoxide. (20) Although this Regulation does not regulate the gas supply conditions in the Member States, it should take into account the fact that different conditions as regards types of gas and supply pressures are in force in the Member States in the absence of harmonisation of the technical characteristics of the gaseous fuel. The composition and specifications of the types of gas and the supply pressures at the place where an appliance is put into service is very important for its safe and correct functioning, therefore that aspect should be taken into consideration at the design phase of the appliance in order to ensure its compatibility with the gas type(s) and supply pressure(s) it is intended for. (21) In order to avoid barriers to trade with regard to appliances on grounds relating to the fact that the gas supply conditions are not yet harmonised and to ensure that economic operators are sufficiently informed, Member States should communicate to the other Member States and to the Commission the types of gas and corresponding supply pressures used on their territory and any changes thereof in good time. (22) The communication of the gas types and supply pressures by Member States should contain the necessary information for economic operators. In that framework, the primary source of the gaseous fuel supplied is not relevant for the characteristics, the performance and the compatibility of appliances with the communicated gas supply conditions. (23) When determining the gas families and gas groups used on their territory, Member States are encouraged to take into account the ongoing standardisation work concerning gas qualities and thus ensure, across the Union, a coherent and coordinated approach towards harmonisation of gaseous fuels via standardisation. (24) When, in accordance with Directive 2009/73/EC of the European Parliament and of the Council (12) and the ongoing standardisation work of CEN on gas quality specifications, Member States take concrete measures for a wider use of biogas by injecting such gas into the gas distribution network or by distributing such gas through isolated systems, they should ensure that they update in a timely manner their communication of the types of gas in the event that the quality of the supplied gas does not remain within the already communicated quality range. (25) When Member States establish their national action plans in accordance with Directive 2009/28/EC in order to comply with their obligation to increase the percentage of renewable energies and in particular biogas in the total energy consumption, they are encouraged to consider the possibilities of injecting such gases into the gas distribution network. (26) Member States should take the necessary measures to ensure that the gas supply conditions do not constitute barriers to trade and that they do not restrict the putting into service of appliances that are compatible with the local gas supply conditions. (27) Appliances covered by this Regulation and complying with it should benefit from the principle of free movement of goods. Such appliances should be allowed to be put into service provided that they are compatible with the local gas supply conditions. (28) The appliance category marking indicated on the appliance or its data plate establishes a direct link with the gas families and/or gas groups for which an appliance has been designed to burn safely at the desired performance level and thus ensures the compatibility of the appliance with the local gas supply conditions. (29) The essential requirements laid down in this Regulation should be observed in order to ensure that appliances are safe when normally used at the desired performance level. (30) The essential requirements should be interpreted and applied so as to take account of the state of the art at the time of design and manufacture as well as of technical and economic considerations which are consistent with a high degree of health and safety protection and rational use of energy. (31) Economic operators should be responsible for the compliance of appliances and of fittings with the requirements of this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety of persons and domestic animals, protection of consumers and of property, and rational use of energy, and to guarantee fair competition on the Union market. (32) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market appliances or fittings which are in conformity with this Regulation. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain. (33) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer. (34) The manufacturer should provide sufficient and detailed information on the intended use of the appliance so as to allow its correct and safe installation and putting into service, use and maintenance. Such information may need to include the technical specifications of the interface between the appliance and its installation environment. (35) This Regulation should not apply to any natural person who manufactures an appliance on a non-professional basis and uses it exclusively for his own purposes. (36) In order to facilitate communication between economic operators, national market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address. (37) It is necessary to ensure that appliances and fittings from third countries entering the Union market comply with the requirements of this Regulation, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those appliances and fittings. Provision should therefore be made for importers to make sure that the appliances and fittings they place on the market comply with the requirements of this Regulation and that they do not place on the market appliances and fittings which do not comply with such requirements or present a risk. Provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that the CE marking on appliances and fittings and documentation drawn up by manufacturers are available for inspection by the competent national authorities. (38) The distributor makes an appliance or a fitting available on the market after it has been placed on the market by the manufacturer or the importer and should act with due care to ensure that its handling of the appliance or fitting does not adversely affect its compliance. (39) When placing an appliance or a fitting on the market, every importer should indicate on the appliance or fitting his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the appliance or fitting does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the appliance or fitting. (40) Any economic operator that either places an appliance or a fitting on the market under his own name or trademark or modifies an appliance or a fitting in such a way that compliance with the requirements of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer. (41) Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the appliance or fitting concerned. (42) Ensuring traceability of an appliance or a fitting throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant appliances or fittings available on the market. When keeping the information required under this Regulation for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with an appliance or a fitting or to whom they have supplied an appliance or a fitting. (43) This Regulation should be limited to the expression of the essential requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for presumption of conformity for appliances and fittings which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements, especially with regard to the design, manufacture, operation, testing, the rational use of energy and installation of appliances. (44) Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Regulation. (45) In order to enable economic operators to demonstrate and the competent authorities to ensure that appliances and fittings made available on the market conform to the essential requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad hoc variants, conformity assessment procedures should be chosen from among those modules. (46) Manufacturers should draw up an EU declaration of conformity to provide information required under this Regulation on the conformity of an appliance or a fitting with the requirements of this Regulation and of other relevant Union harmonisation legislation. (47) To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts for an appliance or a fitting should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity. (48) The CE marking, indicating the conformity of an appliance or a fitting, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship with other markings are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking on appliances and fittings should be laid down in this Regulation. Exceptions should be provided for in cases where the size or nature of the appliance or fitting does not allow the CE marking to be affixed to it. (49) Fittings are not appliances but intermediate products intended for appliance manufacturers and designed to be incorporated into an appliance. However, fittings should satisfy the essential requirements so as to fulfil correctly their intended purpose when incorporated into an appliance or assembled to constitute an appliance. With a view to simplification and in order to avoid any confusion and misunderstanding for manufacturers in meeting their obligations, it is considered justified that fittings should also bear the CE marking. (50) A check on compliance of appliances and of fittings with the essential requirements is necessary in order to provide effective protection of the health and safety of persons, of domestic animals and of property. (51) In order to ensure compliance of appliances and fittings with the essential requirements, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Those procedures should be set from the conformity assessment modules laid down in Decision No 768/2008/EC. (52) The conformity assessment procedures set out in this Regulation require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission. (53) Experience has shown that the criteria set out in Directive 2009/142/EC, that conformity assessment bodies have to fulfil to be notified to the Commission, are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union. It is, however, essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services. (54) In order to ensure a consistent level of conformity assessment quality, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies. (55) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in this Regulation. (56) The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification. (57) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements. (58) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the appliances and the fittings to be placed on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified, and the monitoring of bodies already notified, cover also activities carried out by subcontractors and subsidiaries. (59) It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification. (60) Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies. (61) In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies. (62) Interested parties should have the right to appeal against the result of a conformity assessment carried out by a notified body. For that reason, it is important to ensure that an appeal procedure against decisions taken by notified bodies is available. (63) In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to appliances and fittings covered by this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks. (64) Directive 2009/142/EC already provides for a safeguard procedure which is necessary to allow for the possibility of contesting the conformity of an appliance or fitting. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States. (65) The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to appliances and fittings presenting a risk to the health or safety of persons or to domestic animals or property. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such appliances and fittings. (66) Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard. (67) The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the content of the Member States' communications on the gas supply conditions on their territory. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (68) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (13). (69) The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification. (70) The examination procedure should be used for the adoption of implementing acts to define the form for the Member States' communications on the gas supply conditions on their territory. (71) The examination procedure should also be used for the adoption of implementing acts with respect to compliant appliances and fittings which present a risk to the health or safety of persons or to domestic animals or property. (72) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant appliances or fittings which present a risk to the health or safety of persons, imperative grounds of urgency so require. (73) In line with established practice, the committee set up by this Regulation can play a useful role in examining matters concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure. (74) When matters relating to this Regulation, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should, in line with existing practice, receive full information and documentation and, where appropriate, an invitation to attend such meetings. (75) The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant appliances or fittings are justified or not. (76) It is necessary to provide for reasonable transitional arrangements that allow the making available on the market and the putting into service without the need to comply with further product requirements, of appliances and fittings that have already been placed on the market in accordance with Directive 2009/142/EC before the date of application of this Regulation. Distributors should therefore be able to supply appliances and fittings that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of this Regulation. (77) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive. (78) Since the objective of this Regulation, namely to ensure that appliances and fittings on the Union market fulfil the requirements providing for a high level of protection of health and safety of persons, of domestic animals and of property and for rational use of energy, while guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (79) Directive 2009/142/EC should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Scope 1. This Regulation applies to appliances and fittings. 2. For the purposes of this Regulation, an appliance is considered to be \u2018normally used\u2019 where the following conditions are met: (a) it is correctly installed and regularly serviced in accordance with the manufacturer's instructions; (b) it is used with a normal variation in the gas quality and a normal fluctuation in the supply pressure as set out by Member States in their communication pursuant to Article 4(1); (c) it is used in accordance with its intended purpose or in a way which can be reasonably foreseen. 3. This Regulation does not apply to appliances specifically designed: (a) for use in industrial processes carried out on industrial premises; (b) for use on aircrafts and railways; (c) for research purposes for temporary use in laboratories. For the purposes of this paragraph, an appliance is considered to be \u2018specifically designed\u2019 when the design is only intended to address a specific need for a specific process or use. 4. Where, for appliances or fittings, the aspects covered by this Regulation are covered more specifically by other acts of Union harmonisation legislation, this Regulation does not apply or ceases to apply to such appliances or fittings in respect of those aspects. 5. The rational use of energy essential requirement laid down in point 3.5 of Annex I to this Regulation does not apply to appliances covered by a measure adopted pursuant to Article 15 of Directive 2009/125/EC. 6. This Regulation shall not affect the obligation upon Member States to adopt measures with respect to the promotion of the use of energy from renewable sources and to the energy efficiency of buildings, in accordance with Directives 2009/28/EC, 2010/31/EU and 2012/27/EU. Such measures shall be compatible with the TFEU. Article 2 Definitions For the purposes of this Regulation the following definitions apply: (1) \u2018appliances\u2019 means appliances burning gaseous fuels used for cooking, refrigeration, air-conditioning, space heating, hot water production, lighting or washing, and also forced draught burners and heating bodies to be equipped with such burners; (2) \u2018fittings\u2019 means safety devices, controlling devices or regulating devices and sub-assemblies thereof, designed to be incorporated into an appliance or to be assembled to constitute an appliance; (3) \u2018burning\u2019 means a process in which gaseous fuel reacts with oxygen producing heat or light; (4) \u2018washing\u2019 means the entire washing process, including drying and ironing; (5) \u2018cooking\u2019 means the art or practice of preparing or warming food for consumption with the use of heat and employing a wide range of methods; (6) \u2018gaseous fuel\u2019 means any fuel which is in a gaseous state at a temperature of 15 \u00b0C under an absolute pressure of 1 bar; (7) \u2018industrial process\u2019 means the extraction, growth, refining, processing, production, manufacture or preparation of materials, plants, livestock, animal products, food or other products with a view to their commercial use; (8) \u2018industrial premises\u2019 means any place where the main activity carried out is an industrial process that would be subject to specific national health and safety regulations; (9) \u2018gas family\u2019 means a group of gaseous fuels with similar burning behaviour linked together by a range of Wobbe indices; (10) \u2018gas group\u2019 means a specified range of Wobbe indices within that of the gas family concerned; (11) \u2018Wobbe index\u2019 means an indicator of the interchangeability of fuel gases used to compare the combustion energy output of different composition fuel gases in an appliance; (12) \u2018appliance category\u2019 means the identification of gas families and/or gas groups that an appliance is designed to burn safely and at the desired performance level, as indicated by the appliance category marking; (13) \u2018energy efficiency\u2019 means the ratio of output of performance of an appliance to input of energy; (14) \u2018making available on the market\u2019 means any supply of an appliance or a fitting for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (15) \u2018placing on the market\u2019 means the first making available of an appliance or a fitting on the Union market; (16) \u2018putting into service\u2019 means the first use of an appliance in the Union by its end-user; (17) \u2018manufacturer\u2019 means any natural or legal person who manufactures an appliance or a fitting or who has an appliance or a fitting designed or manufactured, and markets that appliance or fitting under his name or trademark or uses the appliance for his own purposes; (18) \u2018authorised representative\u2019 means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; (19) \u2018importer\u2019 means any natural or legal person established within the Union who places an appliance or a fitting from a third country on the Union market; (20) \u2018distributor\u2019 means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an appliance or a fitting available on the market; (21) \u2018economic operators\u2019 means the manufacturer, the authorised representative, the importer and the distributor; (22) \u2018technical specification\u2019 means a document that prescribes technical requirements to be fulfilled by an appliance or a fitting; (23) \u2018harmonised standard\u2019 means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012; (24) \u2018accreditation\u2019 means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008; (25) \u2018national accreditation body\u2019 means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008; (26) \u2018conformity assessment\u2019 means the process demonstrating whether the essential requirements of this Regulation relating to an appliance or a fitting have been fulfilled; (27) \u2018conformity assessment body\u2019 means a body that performs conformity assessment activities including calibration, testing, certification and inspection; (28) \u2018recall\u2019 means any measure aimed at achieving the return of an appliance that has already been made available to the end-user or of a fitting that has already been made available to an appliance manufacturer; (29) \u2018withdrawal\u2019 means any measure aimed at preventing an appliance or a fitting in the supply chain from being made available on the market; (30) \u2018Union harmonisation legislation\u2019 means any Union legislation harmonising the conditions for the marketing of products; (31) \u2018CE marking\u2019 means a marking by which the manufacturer indicates that the appliance or the fitting is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing. Article 3 Making available on the market and putting into service 1. Appliances shall only be made available on the market and put into service if, when normally used, they comply with this Regulation. 2. Fittings shall only be made available on the market if they comply with this Regulation. 3. This Regulation shall not affect Member States' entitlement to lay down such requirements as they may deem necessary to ensure that persons, domestic animals and property are protected during the normal use of the appliances, provided that this does not mean modifications to the appliances. Article 4 Gas supply conditions 1. By 21 October 2017, Member States shall communicate to the Commission and the other Member States in accordance with Annex II and using the relevant form the types of gas and corresponding supply pressures of gaseous fuels used on their territory. They shall communicate any changes thereof within six months after the announcement of the envisaged changes. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 41 concerning modifications to the content of the Member States' communications of the gas supply conditions on their territory, as set out in Annex II, in order to take into account the technical developments with regard to the gas supply conditions. 3. The Commission may, by means of implementing acts, define the harmonised form of the Member States' communications referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3). 4. The Commission shall ensure that the information provided by Member States in accordance with paragraph 1 is published in the Official Journal of the European Union. Article 5 Essential requirements Appliances and fittings shall meet the essential requirements set out in Annex I which apply to them. Article 6 Free movement 1. Member States shall not, on grounds relating to the aspects covered by this Regulation, prohibit, restrict or impede the making available on the market and the putting into service of appliances which comply with this Regulation. 2. Member States shall not, on grounds relating to the risks covered by this Regulation, prohibit, restrict or impede the making available on the market of fittings which comply with this Regulation. 3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not prevent the showing of appliances or fittings which do not comply with this Regulation, provided that a visible sign clearly indicates that such appliances or fittings do not comply with this Regulation and that they are not for sale until they have been brought into conformity. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons, domestic animals and property. CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS Article 7 Obligations of manufacturers 1. When placing their appliances or fittings on the market or when using the appliances for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I. 2. Manufacturers shall draw up the technical documentation referred to in Annex III (\u2018technical documentation\u2019) and carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out. Where compliance of an appliance or a fitting with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking. 3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the appliance or the fitting has been placed on the market. 4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in appliance or fitting design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the appliance or the fitting is declared shall be adequately taken into account. When deemed appropriate with regard to the risks presented by an appliance, manufacturers shall, to protect the health and safety of consumers and other users, carry out sample testing of appliances made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming appliances and fittings and recalls of such appliances and fittings, and shall keep distributors informed of any such monitoring. 5. Manufacturers shall ensure that their appliances and fittings bear a type, batch or serial number or other element allowing their identification, and the inscriptions provided for in Annex IV. Where the size or nature of the appliance or the fitting does not allow it, manufacturers shall ensure that the required information is provided on the packaging or in a document accompanying the appliance or the fitting. 6. Manufacturers shall indicate on the appliance their name, registered trade name or registered trade mark, and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a document accompanying the appliance. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by consumers and other end-users and the market surveillance authorities. Manufacturers shall indicate on the fitting their name, registered trade name or registered trade mark, and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a document accompanying the fitting. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by appliance manufacturers and the market surveillance authorities. 7. Manufacturers shall ensure that the appliance is accompanied by instructions and safety information in accordance with point 1.5 of Annex I, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible. Manufacturers shall ensure that the fitting is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, in a language which can be easily understood by appliance manufacturers, as determined by the Member State concerned. However, where a large number of fittings are delivered to a single user, the batch or consignment concerned may be accompanied by a single copy of the EU declaration of conformity. 8. Manufacturers who consider or have reason to believe that an appliance or a fitting which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that appliance or fitting into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the appliance or the fitting presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the appliance or the fitting available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the appliance or the fitting with this Regulation, in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by appliances or fittings which they have placed on the market. Article 8 Authorised representatives 1. A manufacturer may, by a written mandate, appoint an authorised representative. The obligations laid down in Article 7(1) and the obligation to draw up technical documentation shall not form part of the authorised representative's mandate. 2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following: (a) keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the appliance or the fitting has been placed on the market; (b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the appliance or the fitting; (c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by appliances or fittings covered by the authorised representative's mandate. Article 9 Obligations of importers 1. Importers shall place only compliant appliances or fittings on the market. 2. Before placing an appliance on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the appliance bears the CE marking and is accompanied by instructions and safety information in accordance with point 1.5 of Annex I, and that the manufacturer has complied with the requirements set out in Article 7(5) and (6). Before placing a fitting on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the fitting bears the CE marking and is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, and that the manufacturer has complied with the requirements set out in Article 7(5) and (6). Where an importer considers or has reason to believe that an appliance or a fitting is not in conformity with the essential requirements set out in Annex I, he shall not place the appliance or the fitting on the market until it has been brought into conformity. Furthermore, where the appliance or the fitting presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect. 3. Importers shall indicate on the appliance their name, registered trade name or registered trade mark, and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the appliance. The contact details shall be in a language easily understood by consumers and other end-users and the market surveillance authorities. Importers shall indicate on the fitting their name, registered trade name or registered trade mark, and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the fitting. The contact details shall be in a language easily understood by appliance manufacturers and the market surveillance authorities. 4. Importers shall ensure that the appliance is accompanied by instructions and safety information in accordance with point 1.5 of Annex I, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Importers shall ensure that the fitting is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, in a language which can be easily understood by appliance manufacturers, as determined by the Member State concerned. 5. Importers shall ensure that, while an appliance or a fitting is under their responsibility, storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Annex I. 6. When deemed appropriate with regard to the risks presented by an appliance, importers shall, to protect the health and safety of consumers and other users, carry out sample testing of appliances made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming appliances and fittings and recalls of such appliances and fittings, and shall keep distributors informed of any such monitoring. 7. Importers who consider or have reason to believe that an appliance or a fitting which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that appliance or fitting into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the appliance or the fitting presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the appliance or the fitting available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 8. Importers shall, for 10 years after the appliance or the fitting has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request. 9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an appliance or a fitting in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by appliances or fittings which they have placed on the market. Article 10 Obligations of distributors 1. When making an appliance or a fitting available on the market distributors shall act with due care in relation to the requirements of this Regulation. 2. Before making an appliance available on the market, distributors shall verify that the appliance bears the CE marking and that it is accompanied by instructions and safety information in accordance with point 1.5 of Annex I, in a language which can be easily understood by consumers and other end-users, as determined by the Member State in which the appliance is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 7(5) and (6) and Article 9(3) respectively. Before making a fitting available on the market, distributors shall verify that the fitting bears the CE marking and that it is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, in a language which can be easily understood by appliance manufacturers, as determined by the Member State concerned, and that the manufacturer and the importer have complied with the requirements set out in Article 7(5) and (6) and Article 9(3) respectively. Where a distributor considers or has reason to believe that an appliance or a fitting is not in conformity with the essential requirements set out in Annex I, he shall not make the appliance or the fitting available on the market until it has been brought into conformity. Furthermore, where the appliance or the fitting presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities. 3. Distributors shall ensure that, while an appliance or a fitting is under their responsibility, storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Annex I. 4. Distributors who consider or have reason to believe that an appliance or a fitting which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring that appliance or fitting into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the appliance or the fitting presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the appliance or the fitting available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 5. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an appliance or a fitting. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by appliances or fittings which they have made available on the market. Article 11 Cases in which obligations of manufacturers apply to importers and distributors An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and he shall be subject to the obligations of the manufacturer under Article 7, where he places an appliance or a fitting on the market under his name or trademark or modifies an appliance or a fitting already placed on the market in such a way that compliance with the requirements of this Regulation may be affected. Article 12 Identification of economic operators Economic operators shall, on request, identify the following to the market surveillance authorities: (a) any economic operator who has supplied them with an appliance or a fitting; (b) any economic operator to whom they have supplied an appliance or a fitting. Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the appliance or the fitting and for 10 years after they have supplied the appliance or the fitting. CHAPTER III CONFORMITY OF APPLIANCES AND FITTINGS Article 13 Presumption of conformity of appliances and fittings Appliances and fittings which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Annex I covered by those standards or parts thereof. Article 14 Conformity assessment procedures for appliances and fittings 1. Before an appliance or a fitting is placed on the market, the manufacturer shall submit it to a conformity assessment procedure in accordance with paragraph 2 or 3. 2. The conformity of series-manufactured appliances and fittings with the requirements of this Regulation shall be assessed by means of the EU type-examination (Module B \u2014 production type) set out in point 1 of Annex III, combined with one of the following modules, at the choice of the manufacturer: (a) conformity to type based on internal production control plus supervised product checks at random intervals (Module C2), set out in point 2 of Annex III; (b) conformity to type based on quality assurance of the production process (Module D), set out in point 3 of Annex III; (c) conformity to type based on product quality assurance (Module E), set out in point 4 of Annex III; (d) conformity to type based on product verification (Module F), set out in point 5 of Annex III. 3. In the case of an appliance or a fitting produced as a single unit or in small quantities, the manufacturer may choose one of the procedures set out in paragraph 2 of this Article or conformity based on unit verification (Module G) set out in point 6 of Annex III. 4. Records and correspondence relating to conformity assessment of an appliance or a fitting shall be drawn up in an official language of the Member State where the notified body carrying out the procedures referred to in paragraphs 2 and 3 is established or in a language accepted by that body. Article 15 EU declaration of conformity 1. The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Annex I has been demonstrated. 2. The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the relevant modules set out in Annex III and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the appliance or the fitting is placed or made available on the market. 3. In order to assist compliance of finished appliances with the applicable essential requirements set out in Annex I, the EU declaration of conformity for a fitting shall state the characteristics of the fitting and shall contain instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance. The EU declaration of conformity shall be in a language which can be easily understood by appliance manufacturers and market surveillance authorities, as determined by the Member State concerned. 4. Where an appliance or a fitting is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references. 5. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the appliance or the fitting with the requirements laid down in this Regulation. 6. A copy of the EU declaration of conformity shall be supplied with the fitting. Article 16 General principles of the CE marking The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. Article 17 Rules and conditions for affixing the CE marking 1. The CE marking shall be affixed visibly, legibly and indelibly to the appliance and the fitting or to their data plate as far as relevant. Where that is not possible or not warranted on account of the nature of the appliance or the fitting, it shall be affixed to the packaging and to the documents accompanying the appliance or the fitting. 2. The CE marking shall be affixed before the appliance or the fitting is placed on the market. 3. The CE marking shall be followed by the identification number of the notified body involved in the production control phase of the appliance or of the fitting and by the last two digits of the year in which the CE marking was affixed. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative. 4. The CE marking and the identification number referred to in paragraph 3 may be followed by any other mark indicating a special risk or use. 5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Article 18 Inscriptions 1. The inscriptions referred to in Annex IV shall be affixed visibly, legibly and indelibly to the appliance or to its data plate and, as far as relevant, to the fitting or to its data plate. 2. The inscriptions referred to in Annex IV shall be affixed before the appliance or the fitting is placed on the market. CHAPTER IV NOTIFICATION OF CONFORMITY ASSESSMENT BODIES Article 19 Notification Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation. Article 20 Notifying authorities 1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 25. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008. 3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 21. In addition, it shall have arrangements to cover liabilities arising out of its activities. 4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3. Article 21 Requirements relating to notifying authorities 1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs. 2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities. 3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment. 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis. 5. A notifying authority shall safeguard the confidentiality of the information it obtains. 6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks. Article 22 Information obligation on notifying authorities Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available. Article 23 Requirements relating to notified bodies 1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. 2. A conformity assessment body shall be established under the national law of a Member State and have legal personality. 3. A conformity assessment body shall be a third-party body independent of the organisation or the appliance or the fitting it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of appliances or fittings which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. 4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the appliances or the fittings which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed appliances or fittings that are necessary for the operations of the conformity assessment body or the use of such appliances or fittings for personal purposes. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those appliances or fittings, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services. Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. 5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. 6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annex III and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. At all times, and for each conformity assessment procedure and each kind or category of appliances or fittings in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary: (a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities; (c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the appliance or fitting technology in question and the mass or serial nature of the production process. A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. 7. The personnel responsible for carrying out conformity assessment tasks shall have the following: (a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; (b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding of the essential requirements set out in Annex I, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of national legislation; (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. 8. The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed. The remuneration of the top level management and of the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments. 9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment. 10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annex III or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected. 11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established pursuant to Article 35 and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group. Article 24 Presumption of conformity of notified bodies Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 23 in so far as the applicable harmonised standards cover those requirements. Article 25 Subsidiaries of and subcontracting by notified bodies 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 23 and shall inform the notifying authority accordingly. 2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established. 3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. 4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex III. Article 26 Application for notification 1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the appliance/fitting or appliances/fittings for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 23. 3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 23. Article 27 Notification procedure 1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 23. 2. They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission. 3. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the appliance/fitting or appliances/fittings concerned and the relevant attestation of competence. 4. Where a notification is not based on an accreditation certificate as referred to in Article 26(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 23. 5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used. Only such a body shall be considered a notified body for the purposes of this Regulation. 6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification. Article 28 Identification numbers and lists of notified bodies 1. The Commission shall assign an identification number to a notified body. It shall assign a single such number even where the body is notified under several Union acts. 2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date. Article 29 Changes to notifications 1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 23 or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. 2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request. Article 30 Challenge of the competence of notified bodies 1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject. 2. The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned. 3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 42(2). Article 31 Operational obligations of notified bodies 1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annex III. 2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the appliance or fitting technology in question and the mass or serial nature of the production process. In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the appliance or the fitting with this Regulation. 3. Where a notified body finds that the essential requirements set out in Annex I or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision. 4. Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, a notified body finds that an appliance or a fitting no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision, if necessary. 5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate. Article 32 Appeal against decisions of notified bodies Notified bodies shall ensure that an appeal procedure against their decisions is available. Article 33 Information obligation on notified bodies 1. Notified bodies shall inform the notifying authority of the following: (a) any refusal, restriction, suspension or withdrawal of a certificate or approval decision; (b) any circumstances affecting the scope of or the conditions for notification; (c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities; (d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting. 2. Notified bodies shall provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same appliances or fittings with relevant information on issues relating to negative and, on request, positive conformity assessment results. Article 34 Exchange of experience The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy. Article 35 Coordination of notified bodies The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group or groups of notified bodies. Notified bodies shall participate in the work of that group or those groups, directly or by means of designated representatives. CHAPTER V UNION MARKET SURVEILLANCE, CONTROL OF APPLIANCES AND FITTINGS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE Article 36 Union market surveillance and control of appliances and fittings entering the Union market Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to appliances and fittings covered by this Regulation. Article 37 Procedure at national level for dealing with appliances or fittings presenting a risk 1. Where the market surveillance authorities of one Member State have sufficient reason to believe that an appliance or fitting covered by this Regulation presents a risk to the health or safety of persons or to domestic animals or property, they shall carry out an evaluation in relation to the appliance or fitting concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose. Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the appliance or fitting does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the appliance or fitting into compliance with those requirements, to withdraw the appliance or fitting from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe. The market surveillance authorities shall inform the relevant notified body accordingly. Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph. 2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take. 3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the appliances and fittings concerned that he has made available on the market throughout the Union. 4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the appliances or fittings being made available on their national market, to withdraw the appliance or fitting from that market or to recall it. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. 5. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant appliance or fitting, the origin of the appliance or fitting, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following: (a) failure of the appliance or fitting to meet requirements relating to the health or safety of persons or to the protection of domestic animals or property; or (b) shortcomings in the harmonised standards referred to in Article 13 conferring a presumption of conformity. 6. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the appliance or fitting concerned, and, in the event of disagreement with the adopted national measure, of their objections. 7. Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. 8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the appliance or fitting from the market, are taken in respect of the appliance or fitting concerned without delay. Article 38 Union safeguard procedure 1. Where, on completion of the procedure set out in Article 37(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. 2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant appliance or fitting is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure. 3. Where the national measure is considered justified and the non-compliance of the appliance or fitting is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 37(5) of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012. Article 39 Compliant appliances or fittings which present a risk 1. Where, having carried out an evaluation under Article 37(1), a Member State finds that although an appliance or fitting is in compliance with this Regulation, it presents a risk to the health or safety of persons or to domestic animals or property, it shall require the relevant economic operator to take all appropriate measures to ensure that the appliance or fitting concerned, when placed on the market, no longer presents that risk, to withdraw the appliance or fitting from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe. 2. The economic operator shall ensure that corrective action is taken in respect of all the appliances or fittings concerned that he has made available on the market throughout the Union. 3. The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the appliance or fitting concerned, the origin and the supply chain of the appliance or fitting, the nature of the risk involved and the nature and duration of the national measures taken. 4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide by means of implementing acts whether the national measure is justified or not and, where necessary, propose appropriate measures. The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 42(3). On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 42(4). 5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. Article 40 Formal non-compliance 1. Without prejudice to Article 37, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 17 of this Regulation; (b) the CE marking has not been affixed; (c) the inscriptions referred to in Annex IV have not been affixed or have been affixed in violation of Article 18; (d) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 17 or has not been affixed; (e) the EU declaration of conformity has not been drawn up or has not been drawn up correctly; (f) a copy of the EU declaration of conformity does not accompany the fitting; (g) the technical documentation is either not available or not complete; (h) the information referred to in Article 7(6) or Article 9(3) is absent, false or incomplete; (i) any other administrative requirement provided for in Article 7 or Article 9 is not fulfilled. 2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the appliance or fitting being made available on the market or ensure that it is recalled or withdrawn from the market. CHAPTER VI DELEGATED ACTS AND COMMITTEE PROCEDURE Article 41 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 4(2) shall be conferred on the Commission for a period of five years from 21 April 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. It is of particular importance that the Commission follow its usual practice and carry out consultations with experts, including Member States' experts, before adopting those delegated acts. 3. The delegation of power referred to in Article 4(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 4(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 42 Committee procedure 1. The Commission shall be assisted by the Committee on appliances. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. 5. The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by any other Union legislation. The committee may furthermore examine any other matter concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure. CHAPTER VII TRANSITIONAL AND FINAL PROVISIONS Article 43 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements by economic operators of the provisions of this Regulation. Such rules may include criminal penalties for serious infringements. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify those rules to the Commission by 21 March 2018 and shall notify it without delay of any subsequent amendment affecting them. 2. Member States shall take all measures necessary to ensure that their rules on penalties applicable to infringements by economic operators of the provisions of this Regulation are enforced. Article 44 Transitional provisions 1. Member States shall not impede the making available on the market or the putting into service of appliances covered by Directive 2009/142/EC which are in conformity with that Directive and which were placed on the market before 21 April 2018. 2. Member States shall not impede the making available on the market of fittings covered by Directive 2009/142/EC which are in conformity with that Directive and which were placed on the market before 21 April 2018. Article 45 Repeal Directive 2009/142/EC is repealed with effect from 21 April 2018. References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI. Article 46 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. This Regulation shall apply from 21 April 2018, with the exception of: (a) Articles 4, 19 to 35 and 42 and Annex II, which shall apply from 21 October 2016; (b) Article 43(1), which shall apply from 21 March 2018 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 March 2016. For the European Parliament The President M. SCHULZ For the Council The President J.A. HENNIS-PLASSCHAERT (1) OJ C 458, 19.12.2014, p. 25. (2) Position of the European Parliament of 20 January 2016 (not yet published in the Official Journal) and decision of the Council of 12 February 2016. (3) Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels (OJ L 330, 16.12.2009, p. 10). (4) OJ C 136, 4.6.1985, p. 1. (5) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European Standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (6) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). (7) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (8) Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10). (9) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, p. 16). (10) Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13). (11) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1). (12) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94). (13) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). ANNEX I ESSENTIAL REQUIREMENTS PRELIMINARY OBSERVATIONS: 1. The essential requirements laid down in this Regulation are compulsory. 2. The essential requirements are to be interpreted and applied in such a way as to take into account the state of the art and current practice at the time of design and manufacture as well as technical and economic considerations which are consistent with a high degree of energy efficiency and of health and safety protection. 1. GENERAL REQUIREMENTS 1.1. Appliances shall be so designed and constructed as to operate safely and present no danger to persons, domestic animals or property, when normally used. Fittings shall be so designed and constructed as to fulfil correctly their intended purpose when incorporated into an appliance or assembled to constitute an appliance. 1.2. The manufacturer is under an obligation to analyse the risks in order to identify those which apply to his appliance or fitting. He shall then design and construct it taking into account its risk assessment. 1.3. In selecting the most appropriate solutions, the manufacturer shall apply the principles set out below, in the following order: (a) eliminate or reduce risks as far as possible (inherently safe design and construction); (b) take the necessary protection measures in relation to risks that cannot be eliminated; (c) inform users of the residual risks due to any shortcomings of the protection measures adopted and indicate whether any particular precautions are required. 1.4. When designing and constructing the appliance, and when drafting the instructions, the manufacturer shall envisage not only the intended use of the appliance, but also the reasonably foreseeable uses. 1.5. All appliances shall: (a) be accompanied by instructions for installation intended for the installer; (b) be accompanied by instructions for use and servicing, intended for the user; (c) bear appropriate warning notices, which shall also appear on the packaging. 1.6.1. The instructions for installation intended for the installer shall contain all the instructions for installation, adjustment and servicing required to ensure that those operations are correctly performed so that the appliance may be used safely. The instructions for installation intended for the installer shall include also information on the technical specifications of the interface between the appliance and its installation environment allowing its correct connection to the gas supply network, the supply of auxiliary energy, the combustion air supply and the flue gas evacuation system. 1.6.2. The instructions for use and servicing intended for the user shall contain all the information required for safe use and in particular shall draw the user's attention to any restrictions on use. The manufacturers shall note in the instructions where additional care is needed or where it would be advisable that any of the above work be carried out by a professional. This shall be without prejudice to national requirements to that effect. The manufacturer of the appliance shall include in the instructions accompanying the appliance all necessary information for adjustment, operation and maintenance of the fittings as part of the finished appliance, as appropriate. 1.6.3. The warning notices on the appliance and its packaging shall clearly state the type of gas to be used, the gas supply pressure, the appliance category and any restrictions on use, in particular the restriction whereby the appliance shall be installed only in areas where there is sufficient ventilation so as to ensure that the risks presented by it are minimised. 1.7. The instructions for incorporation of the fitting into an appliance or its assembly in order to constitute an appliance and for its adjustment, operation and maintenance shall be provided with the fittings concerned as part of the EU declaration of conformity. 2. MATERIALS Materials for appliances or fittings shall be appropriate for their intended purpose and shall withstand the mechanical, chemical and thermal conditions to which they will foreseeably be subjected. 3. DESIGN AND CONSTRUCTION The obligations arising for appliances from the essential requirements set out in this point apply also to fittings, as far as relevant. 3.1. General 3.1.1. Appliances shall be so designed and constructed that, when normally used, no instability, distortion, breakage or wear likely to impair their safety may occur. 3.1.2. Condensation produced at the start-up and/or during use shall not affect the safety of appliances. 3.1.3. Appliances shall be so designed and constructed as to minimise the risk of explosion in the event of a fire of external origin. 3.1.4. Appliances shall be so designed and constructed that water and inappropriate air penetration into the gas circuit does not occur. 3.1.5. In the event of a normal fluctuation of auxiliary energy, appliances shall continue to operate safely. 3.1.6. Abnormal fluctuation or failure of auxiliary energy or its restoration shall not lead to an unsafe situation. 3.1.7. Appliances shall be so designed and constructed as to obviate any gas-related risks due to hazards of electrical origin. As far as relevant, the results of the conformity assessment in relation to the safety requirements of Directive 2014/53/EU of the European Parliament and of the Council (1) or the safety objectives of Directive 2014/35/EU of the European Parliament and of the Council (2) shall be taken into account. 3.1.8. Appliances shall be so designed and constructed as to obviate any gas-related risks due to hazards originating from electromagnetic phenomena. As far as relevant, the results of the conformity assessment in relation to the electromagnetic compatibility requirements of Directive 2014/53/EU or Directive 2014/30/EU of the European Parliament and of the Council (3) shall be taken into account. 3.1.9. All pressurised parts of an appliance shall withstand the mechanical and thermal stresses to which they are subjected without any deformation affecting safety. 3.1.10. Appliances shall be so designed and constructed that failure of a safety, controlling or regulating device may not lead to an unsafe situation. 3.1.11. If an appliance is equipped with safety and controlling devices, the functioning of the safety devices shall not be overruled by that of the controlling devices. 3.1.12. All parts of appliances which are set or adjusted at the stage of manufacture and which should not be manipulated by the user or the installer shall be appropriately protected. 3.1.13. Levers and other controlling and setting devices shall be clearly marked and give appropriate instructions so as to prevent any error in operation/use. Their design shall be such as to preclude accidental operation. 3.2. Unburned gas release 3.2.1. Appliances shall be so designed and constructed that the gas leakage rate is not dangerous. 3.2.2. Appliances shall be so designed and constructed that gas release at any state of operation is limited in order to avoid a dangerous accumulation of unburned gas in the appliance. 3.2.3. Appliances intended to be used in indoor spaces and rooms shall be so designed and constructed as to prevent the release of unburned gas in all situations which could lead to a dangerous accumulation of unburned gas in such spaces and rooms. 3.2.4. Appliances designed and constructed to burn gas containing carbon monoxide or other toxic components shall not present a danger to the health of persons and domestic animals exposed. 3.3. Ignition Appliances shall be so designed and constructed that, when normally used, ignition and re-ignition is smooth and cross-lighting is assured. 3.4. Combustion 3.4.1. Appliances shall be so designed and constructed that, when normally used, the combustion process is stable and combustion products do not contain unacceptable concentrations of substances harmful to health. 3.4.2. Appliances shall be so designed and constructed that, when normally used, there will be no accidental release of combustion products. 3.4.3. Appliances connected to a flue for the dispersal of combustion products shall be so designed and constructed that in abnormal draught conditions there is no release of combustion products in a dangerous quantity into the indoor spaces or rooms concerned. 3.4.4. Appliances shall be so designed and constructed that, when normally used, they do not cause a concentration of carbon monoxide or other substances harmful to health, such as they would be likely to present a danger to the health of persons and domestic animals exposed. 3.5. Rational use of energy Appliances shall be so designed and constructed as to ensure rational use of energy, reflecting the state of the art and taking into account safety aspects. 3.6. Temperature 3.6.1. Parts of appliances which are intended to be installed or placed in close proximity to surfaces shall not reach temperatures which present a danger. 3.6.2. The surface temperature of parts of appliances intended to be handled during normal use shall not present a danger to the user. 3.6.3. The surface temperatures of external parts of appliances, with the exception of surfaces or parts which are associated with the transmission of heat, shall not under operating conditions present a danger to the health and safety of persons exposed and in particular to children and elderly people, for whom an appropriate reaction time shall be taken into account. 3.7. Contact with food and water intended for human consumption Without prejudice to Regulations (EC) No 1935/2004 (4) and (EU) No 305/2011 (5) of the European Parliament and of the Council, materials and parts used in the construction of an appliance which may come into contact with food or water intended for human consumption as defined in Article 2 of Council Directive 98/83/EC (6), shall not impair quality of the food or water. (1) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). (2) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357). (3) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). (4) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4). (5) Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5). (6) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32). ANNEX II CONTENT OF THE MEMBER STATES COMMUNICATIONS OF THE GAS SUPPLY CONDITIONS 1. The communications of the Member States to the Commission and the other Member States provided for in Article 4 shall have the following content: (a) (i) gross calorific value (GCV) in MJ/m3 minimum/maximum; (ii) Wobbe index in MJ/m3 minimum/maximum. (b) Gas composition by volume in % of the total content: \u2014 C1 to C5 content in % (sum) minimum/maximum; \u2014 N2 + CO2 content in % minimum/maximum; \u2014 CO content in % minimum/maximum; \u2014 unsaturated HC content in % minimum/maximum; \u2014 hydrogen content in % minimum/maximum. (c) Information on toxic components contained in the gaseous fuel. That communication shall also include either of the following: (a) supply pressure at the inlet of appliances in mbar: nominal/minimum/maximum; (b) (i) supply pressure at the point of delivery in mbar: nominal/minimum/maximum; (ii) admissible pressure loss in the end-user gas installation in mbar: nominal/minimum/maximum. 2. The reference conditions for Wobbe index and gross calorific value shall be the following: (a) combustion reference temperature: 15 \u00b0C; (b) volume measurement reference temperature: 15 \u00b0C; (c) volume measurement reference pressure: 1 013,25 mbar. ANNEX III CONFORMITY ASSESSMENT PROCEDURES FOR APPLIANCES AND FITTINGS 1. MODULE B: EU TYPE-EXAMINATION \u2014 PRODUCTION TYPE 1.1. EU type-examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an appliance or a fitting and verifies and attests that the technical design of the appliance or the fitting meets the requirements of this Regulation that apply to it. 1.2. EU type-examination shall be carried out by assessment of the adequacy of the technical design of the appliance or the fitting through examination of the technical documentation and supporting evidence referred to in point 1.3, plus examination of a specimen, representative of the production envisaged, of the complete appliance or fitting (production type). 1.3. The manufacturer shall lodge an application for EU type-examination with a single notified body of his choice. 1.3.1. The application shall include the following: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) the technical documentation. The technical documentation shall make it possible to assess the appliance's or fitting's conformity with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the appliance or the fitting. The technical documentation shall contain, wherever applicable, at least the following elements: (1) a general description of the appliance or the fitting; (2) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.; (3) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the appliance or the fitting; (4) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; (5) results of design calculations made, examinations carried out, etc.; (6) test reports; (7) instructions for installation and use of the appliance; (8) the EU declaration of conformity of the fitting containing the instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance; (d) the specimens representative of the production envisaged. The notified body may request further specimens where needed for carrying out the test programme; (e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. 1.3.2. Where appropriate, the manufacturer shall also submit to the notified body the following documents: (a) the EU type-examination certificate and the EU declaration of conformity relating to the fittings incorporated into the appliance; (b) attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance or the fitting; (c) any other document making it possible for the notified body to improve its assessment. 1.4. The notified body shall: For the appliance or the fitting: 1.4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the appliance or the fitting. For the specimen(s): 1.4.2. verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications; 1.4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly; 1.4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Regulation; 1.4.5. agree with the manufacturer on a location where the examinations and tests will be carried out. 1.5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 1.4 and their outcomes. Without prejudice to its obligations vis-\u00e0-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. 1.6. Where the appliance or the fitting type meets the requirements of this Regulation, the notified body shall issue an EU type-examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity, the necessary data for identification of the approved type, such as the type of gas, appliance category and gas supply pressure, and, if relevant, descriptions of its functioning. The certificate may have one or more annexes attached. The EU type-examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured appliances or fittings with the examined type to be evaluated and to allow for in-service control. It shall also indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved type. The certificate shall have a maximum validity period of ten years from the date of its issue. Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 1.7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU type-examination certificate of all modifications to the approved type that may affect the conformity of the appliance or the fitting with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate. 1.8. Each notified body shall inform its notifying authority concerning the EU type-examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU type-examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate. 1.9. The manufacturer shall keep a copy of the EU type-examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. 1.10. The manufacturer's authorised representative may lodge the application referred to in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9, provided that they are specified in the mandate. 2. MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS 2.1. Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2.2, 2.3 and 2.4, and ensures and declares on his sole responsibility that the appliances or the fittings concerned are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them. 2.2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the type described in the EU type-examination certificate and with the requirements of this Regulation that apply to them. 2.3. Product checks A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at intervals of one year or less, in order to verify the quality of the internal checks on the appliance or the fitting, taking into account, inter alia, the technological complexity of the appliances or the fittings and the quantity of production. An adequate sample of the final appliances or fittings taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to check the conformity of the appliance or the fitting with the relevant requirements of this Regulation. Where a sample does not conform to the acceptable quality level, the notified body shall take appropriate measures. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the appliance or the fitting performs within acceptable limits, with a view to ensuring conformity of the appliance or the fitting. The manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process. 2.4. CE marking and EU declaration of conformity 2.4.1. The manufacturer shall affix the CE marking to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation. 2.4.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities for 10 years after the appliance or fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment. 2.5. Authorised representative The manufacturer's obligations set out in point 2.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. 3. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS 3.1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 3.2 and 3.5, and ensures and declares on his sole responsibility that the appliances or fittings concerned are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them. 3.2. Manufacturing The manufacturer shall operate an approved quality system for production, final product inspection and testing of the appliances or fittings concerned as specified in point 3.3, and shall be subject to surveillance as specified in point 3.4. 3.3. Quality system 3.3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the appliances or fittings concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) all relevant information for the appliance or the fitting approved under module B; (d) the documentation concerning the quality system; (e) the technical documentation of the approved type and a copy of the EU type-examination certificate. 3.3.2. The quality system shall ensure that the appliances or fittings are in conformity with the type described in the EU type-examination certificate and comply with the requirements of this Regulation that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out; (d) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.; (e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system. 3.3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and the product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.3.1(e), to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the appliance or the fitting with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 3.4. Surveillance under the responsibility of the notified body 3.4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 3.4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. 3.4.3. The notified body shall carry out periodic audits at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 3.4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 3.5. CE marking and EU declaration of conformity 3.5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation. 3.5.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment. 3.6. The manufacturer shall, for a period ending at least 10 years after the appliance or the fitting has been placed on the market, keep at the disposal of the national authorities: (a) the documentation referred to in point 3.3.1; (b) the information relating to the change referred to in point 3.3.5, as approved; (c) the decisions and reports of the notified body referred to in points 3.3.5, 3.4.3 and 3.4.4. 3.7. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality systems approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued. 3.8. Authorised representative The manufacturer's obligations set out in points 3.3.1, 3.3.5, 3.5 and 3.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. 4. MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE 4.1. Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 4.2 and 4.5, and ensures and declares on his sole responsibility that the appliances or fittings concerned are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them. 4.2. Manufacturing The manufacturer shall operate an approved quality system for final product inspection and testing of the appliances or fittings concerned as specified in point 4.3 and shall be subject to surveillance as specified in point 4.4. 4.3. Quality system 4.3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the appliances or fittings concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) all relevant information for the product category envisaged; (d) the documentation concerning the quality system; and (e) the technical documentation of the approved type and a copy of the EU type-examination certificate. 4.3.2. The quality system shall ensure compliance of the appliances or the fittings with the type described in the EU type-examination certificate and with the applicable requirements of this Regulation. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the examinations and tests that will be carried out after manufacture; (c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.; (d) the means of monitoring the effective operation of the quality system. 4.3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 4.3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 4.3.1(e), in order to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the appliance or the fitting with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 4.3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 4.3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 4.3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 4.4. Surveillance under the responsibility of the notified body 4.4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. 4.4.3. The notified body shall carry out periodic audits at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 4.4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 4.5. CE marking and EU declaration of conformity 4.5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation. 4.5.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment. 4.6. The manufacturer shall, for a period ending at least 10 years after the appliance or the fitting has been placed on the market, keep at the disposal of the national authorities: (a) the documentation referred to in point 4.3.1; (b) the information relating to the change referred to in point 4.3.5, as approved; (c) the decisions and reports of the notified body referred to in points 4.3.5, 4.4.3 and 4.4.4. 4.7. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued. 4.8. Authorised representative The manufacturer's obligations set out in points 4.3.1, 4.3.5, 4.5 and 4.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. 5. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION 5.1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 5.2, 5.5.1 and 5.6, and ensures and declares on his sole responsibility that the appliances or fittings concerned, which have been subject to point 5.3, are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them. 5.2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the approved type described in the EU type-examination certificate and with the requirements of this Regulation that apply to them. 5.3. Verification A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the appliances or fittings with the approved type described in the EU type-examination certificate and with the appropriate requirements of this Regulation. The examinations and tests to check the conformity of the appliances or fittings with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every appliance or fitting as specified in point 5.4 or by examination and testing of the appliances or fittings on a statistical basis as specified in point 5.5. 5.4. Verification of conformity by examination and testing of every appliance or fitting 5.4.1. All appliances or fittings shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify conformity with the approved type described in the EU type-examination certificate and with the appropriate requirements of this Regulation. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. 5.4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved appliance or fitting, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the appliance or the fitting has been placed on the market. 5.5. Statistical verification of conformity 5.5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his appliances or fittings for verification in the form of homogeneous lots. 5.5.2. A random sample shall be taken from each lot in accordance with the requirements of point 5.5.3. All appliances or fittings in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. 5.5.3. The notified body shall apply a sampling system with the following characteristics: \u2014 a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,5 % and 1,5 %, \u2014 a limit quality corresponding to a probability of acceptance of 5 % with a non-conformity percentage of between 5 % and 10 %. 5.5.4. If a lot is accepted, all appliances or fittings of the lot shall be considered approved, except for those appliances or fittings from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved appliance or fitting, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. 5.5.5. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures. 5.6. CE marking and EU declaration of conformity 5.6.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.3, the latter's identification number to each individual appliance or fitting that is in conformity with the approved type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation. 5.6.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities, for 10 years after the appliance or the fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment. If the notified body referred to in point 5.3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the appliance or the fitting. 5.7. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the appliances or the fittings during the manufacturing process. 5.8. Authorised representative The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in points 5.2 and 5.5.1. 6. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION 6.1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 6.2, 6.3 and 6.5, and ensures and declares on his sole responsibility that the appliance or the fitting concerned, which has been subject to point 6.4, is in conformity with the requirements of this Regulation that apply to it. 6.2. Technical documentation The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 6.4. The technical documentation shall make it possible to assess the appliance's or fitting's conformity with the applicable requirements of this Regulation, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the appliance or the fitting. 6.2.1. The technical documentation shall, wherever applicable, contain at least the following elements: (a) a general description of the appliance or the fitting; (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.; (c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the appliance or the fitting; (d) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; (e) results of design calculations made, examinations carried out, etc.; (f) test reports; (g) instructions for installation and use, for appliances; (h) instructions for incorporation into an appliance or for assembly, for fittings. 6.2.2. Where appropriate, the manufacturer shall also submit to the notified body the following documents: (a) the EU type-examination certificate and the EU declaration of conformity relating to the fittings incorporated into the appliance; (b) attestations and certificates relating to the methods of manufacture and inspection and monitoring of the appliance or the fitting; (c) any other document making it possible for the notified body to improve its assessment. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the appliance or the fitting has been placed on the market. 6.3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the applicable requirements of this Regulation. 6.4. Verification A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the appliances or fittings with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out. If deemed necessary by the notified body, the examinations and tests may be carried out after the incorporation of the fitting, the assembly or the installation of the appliance. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved appliances or fittings, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. 6.5. CE marking and EU declaration of conformity 6.5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 6.4, the latter's identification number to each appliance or fitting that satisfies the applicable requirements of this Regulation. 6.5.2. The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or the fitting for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment. 6.6. Authorised representative The manufacturer's obligations set out in points 6.2 and 6.5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. ANNEX IV INSCRIPTIONS 1. In addition to the CE marking referred to in Article 16, the appliance or its data plate shall bear the following information: (a) the manufacturer's name, registered trade name or registered trade mark; (b) the appliance type, batch or serial number of the appliance or other element allowing its identification; (c) the type of electrical supply used, where applicable; (d) the appliance category marking; (e) the nominal supply pressure for the appliance; (f) the necessary information to ensure correct and safe installation, according to the nature of the appliance. 2. The fitting or its data plate shall bear, as far as relevant, the information provided for in point 1. ANNEX V EU DECLARATION OF CONFORMITY No \u2026 (1) 1. Appliance or fitting /appliance or fitting model (product, type, batch or serial number): 2. Name and address of the manufacturer and, where applicable, his authorised representative: 3. This declaration of conformity is issued under the sole responsibility of the manufacturer. 4. Object of the declaration (identification of the appliance or fitting allowing traceability; where necessary for the identification of the appliance or the fitting, an image may be included): description of the appliance or the fitting. 5. The object of the declaration described in point 4 is in conformity with the relevant Union harmonisation legislation: \u2026 (reference to the other Union acts applied). 6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared: 7. The notified body \u2026 (name, address, number) \u2026 performed \u2026 (description of intervention) \u2026 and issued the certificate(s): \u2026 (details, including its date, and, where appropriate, information on the duration and conditions of its validity). 8. In the case of fittings, instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance in order to assist compliance with the essential requirements applicable to finished appliances. 9. Additional information: Signed for and on behalf of: \u2026 (place and date of issue): (name, function) (signature): (1) It is optional for the manufacturer to assign a number to the declaration of conformity. ANNEX VI CORRELATION TABLE Directive 2009/142/EC This Regulation Article 1(1) first subparagraph Article 1(1) Article 1(1) second subparagraph Article 1(3)(a) \u2014 Article 1(3)(b) and (c) \u2014 Article 1(4) to (6) Article 1(2) Article 2, points 1, 2 and 6 Article 1(3) Article 1(2) \u2014 Article 2, points 3, 4, 5, 7 to 31 Article 2(1) Article 3(1) \u2014 Article 3(2) and (3) Article 2(2) Article 4(1) and (4) \u2014 Article 4(2) and (3) Article 3 Article 5 Article 4 Article 6(1) and (2) \u2014 Article 6(3) \u2014 Article 7 \u2014 Article 8 \u2014 Article 9 \u2014 Article 10 \u2014 Article 11 \u2014 Article 12 \u2014 Article 13 Article 5(1)(a) \u2014 Article 5(1)(b) \u2014 Article 5(2) \u2014 Article 6 \u2014 Article 7 \u2014 Article 8(1), (2) and (4) Article 14(1) to (3) Article 8(3) and (5) \u2014 Article 8(6) Article 14(4) \u2014 Article 15 \u2014 Article 16 Article 9 \u2014 Article 10 \u2014 \u2014 Article 17 Article 11 \u2014 Article 12 \u2014 \u2014 Article 18 \u2014 Article 19 \u2014 Article 20 \u2014 Article 21 \u2014 Article 22 \u2014 Article 23 \u2014 Article 24 \u2014 Article 25 \u2014 Article 26 \u2014 Article 27 \u2014 Article 28 \u2014 Article 29 \u2014 Article 30 \u2014 Article 31 \u2014 Article 32 \u2014 Article 33 \u2014 Article 34 \u2014 Article 35 \u2014 Article 36 \u2014 Article 37 \u2014 Article 38 \u2014 Article 39 \u2014 Article 40 \u2014 Article 41 \u2014 Article 42 \u2014 Article 43 \u2014 Article 44 Article 13 \u2014 Article 14 \u2014 Article 15 \u2014 Article 16 \u2014 \u2014 Article 45 \u2014 Article 46 Annex I Annex I \u2014 Annex II Annex II Annex III Annex III Annex IV Annex IV \u2014 Annex V \u2014 Annex VI \u2014 \u2014 Annex V \u2014 Annex VI", "summary": "Appliances burning gaseous fuels (from 2018) Appliances burning gaseous fuels (from 2018) SUMMARY OF: Regulation (EU) 2016/426 on appliances burning gaseous fuels WHAT IS THE AIM OF THE REGULATION? It modifies and updates rules set out in earlier legislation (Directive 2009/142/EC). It establishes the rules for the placing on the market and putting into service of appliances burning gaseous fuels and their fittings. It provides access to the European Union (EU) market for the appliances and fittings covered as far as their gas safety is concerned. It deals with the energy efficiency of these products, unless other more specific EU legislation applies. KEY POINTS Scope The regulation applies to gas appliances and fittings where: \u2018appliances\u2019 are appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing as well as forced draught burners* and heaters to be equipped with such burners; \u2018fittings\u2019 are safety devices, controlling devices or regulating devices and their parts, designed to be fitted into an appliance burning gaseous fuel or used to build such an appliance. The regulation does not apply to specially designed appliances for use: in industrial processes carried out on industrial premises; on aircraft and railways; or for temporary research purposes in laboratories. Conditions to be met when placing appliances or fittings on the market Appliances and fittings must comply with the regulation \u2014 whose essential requirements are set out in Annex I \u2014 before they can be placed on the market and put into service in the EU. Appliances covered by the regulation must be designed and built in such a way as to operate safely and present no danger to persons, domestic animals or property when used normally*. All appliances must be accompanied by: technical instructions for the installer, containing all the instructions for installation, adjustment and servicing required to ensure that those operations are correctly performed, and that the appliance may be used safely, including, for example details of the type of gas and supply pressure used the flow of fresh air required, as well as the conditions for the dispersal of combustion products; instructions for use and servicing intended for the user containing all the information required for safe use and drawing the user\u2019s attention to any restrictions on use; warnings indicating the type of gas to be used, the gas supply pressure and any restrictions on use, in particular the restrictions on installing the appliance only in areas where there is sufficient ventilation. Type-examination The manufacturer must lodge an application for an EU type-examination with a single notified body*. This application must include: the manufacturer\u2019s name and address; a written declaration that the application has not been lodged with any other notified body; technical documentation, as described in this regulation. Where the type satisfies the criteria laid down by this regulation, the notified body must issue an EU type-examination certificate to the applicant. EU declaration of conformity Before placing an appliance or a fitting type on the market, the manufacturer must subject it to a production phase surveillance by a notified body. After a successful conformity assessment of the product, the manufacturer must draw up an EU declaration of conformity* declaring that the product concerned conforms to the requirements of this regulation. The gas appliance or its data plate must bear the CE marking and the following information: the manufacturer\u2019s name; registered trade name; appliance category; and the gas supply pressure; the last two digits of the year in which the \u2018CE\u2019 marking was added. Manufacturers must keep relevant technical documentation and the EU declaration of conformity for 10 years after the placing on the market of the appliance/fitting; inform national authorities of any appliance that might pose a risk. Importers must ensure that appliances and fittings that they place on the market comply with this regulation, including that conformity assessment procedures have been carried out and that the CE marking and documentation drawn up by manufacturers are available for inspection by the authorities. Their name and contact details should be indicated on the appliance or fitting. Distributors must ensure they act with due care to ensure that their handling of an appliance or fitting does not affect its compliance; verify that any appliance they make available on the market bears the CE marking and is accompanied by a declaration of conformity EU governments inform the European Commission of the notified bodies which are authorised to carry out the conformity assessment tasks. The Commission coordinates the mutual collaboration between national authorities. EU countries must inform the Commission of the types of gas and corresponding supply pressures used on their territory by 21 October 2017. They must also notify any subsequent changes in these conditions in advance. EU countries must have penalties in place for any violations of the law by 21 March 2018. FROM WHEN DOES THE REGULATION APPLY? It applies from 21 April 2018, apart from certain articles dealing largely with notification bodies and procedures, as well as the notification of the types of gas and corresponding supply pressures used on EU countries\u2019 territories. These apply from 21 October 2016. BACKGROUND For more information, see: \u2018Gas appliances\u2019 on the European Commission's website. * KEY TERMS Forced draught burner: the air is brought into the head of the burner by means of a forced draught blower or fan. Normal use: considered to be when an appliance is:correctly installed and regularly serviced according to the manufacturer\u2019s instructions;used with a normal variation in the gas quality and a normal fluctuation in the supply pressure;used in accordance with its intended purpose or in a way which can be reasonably expected. Notified body: It assesses conformity under the conditions laid down by EU regulations. This is a service offered to manufacturers in the public interest. EU declaration of conformity to type: a manufacturer declares that the appliances conform with the type as described in the EU type-examination certificate and satisfy the essential requirements of this regulation (CE marking). MAIN DOCUMENT Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, pp. 99\u2013147) RELATED DOCUMENTS Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels (OJ L 330, 16.12.2009, pp. 10\u201327) last update 06.03.2017"}
{"article": "29.11.2011 EN Official Journal of the European Union L 316/1 REGULATION (EU) No 1214/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 November 2011 on the professional cross-border transport of euro cash by road between euro-area Member States THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 133 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The introduction of the euro has considerably increased the need for cross-border transport of cash by road. Within the euro area, banks, the large retail sector and other professional cash handlers should be able to contract with the cash-in-transit (CIT) company that offers the best price and/or service and to take advantage of the cash services of the nearest national central bank (NCB) branch or CIT cash centre, even if it is located in another Member State. Furthermore, a large number of Member States whose currency is the euro (hereinafter \u2018participating Member States\u2019) have arranged, or may want to arrange for, euro banknotes and coins to be produced abroad. The very principle of a single currency implies the freedom to move cash between participating Member States. (2) Due to the marked differences between Member States\u2019 national law, it is generally very difficult to carry out the professional cross-border transport of euro cash by road between participating Member States. This situation is in contradiction to the principle of the free circulation of the euro and is to the detriment of the principle of freedom to provide services, which are among the fundamental principles of the European Union. (3) This Regulation is the response to the possible presentation of harmonisation instruments for the transport of cash, as expressed in Article 38(b) of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (3). (4) With a view to improving CIT security for both the CIT security staff involved and the public, use of the intelligent banknote neutralisation system (IBNS) should be encouraged and, after a thorough analysis of the potential impacts by the Commission, should be capable of being developed in a manner entailing harmonisation of IBNS among the participating Member States, without prejudice to the rules set out in this Regulation on applicable transport arrangements. (5) In view of the particular dangers to the health and life of both CIT security staff and the general public that are associated with the activity of transporting cash, it is appropriate that the cross-border transport of euro cash be subject to holding a specific cross-border CIT-licence. Such a licence should be held in addition to the national CIT licence that is required in most participating Member States, the form of which this Regulation does not harmonise. It is, moreover, appropriate that CIT companies established in those participating Member States which do not have a specific approval procedure for CIT-companies in addition to their general rules for the security or transport sectors, demonstrate a minimum experience of 24 months of regularly transporting cash in the Member State of establishment without infringing national law before they are granted a cross-border CIT licence by that Member State. Such an approach would increase mutual confidence between Member States. (6) In order to avoid the duplication of obligations and the introduction of an unnecessarily burdensome procedure, it is furthermore appropriate to provide that the holder of a cross-border CIT licence is not required also to hold a Community licence for the international carriage of goods by road, as laid down in Regulation (EC) No 1072/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international road haulage market (4). (7) The professional cross-border transport of euro cash by road between participating Member States should fully comply with this Regulation or with the law of the Member State of origin, the host Member State and, if applicable, the Member State of transit. (8) This Regulation is designed to allow the professional cross-border transport of euro cash by road between participating Member States under conditions that guarantee the security of the transaction, the safety of the CIT security staff involved and of the public and the free movement of euro cash. In accordance with normal market practice, it is also appropriate to allow a limited value of non-euro cash to be transported in the same CIT vehicle. (9) In view of the specific requirements facing cross-border CIT workers, it is appropriate that they follow a specific cross-border training module as detailed in Annex VI. In order to avoid unnecessary duplication, the cross-border training module should not include the elements already covered by compulsory training required for carrying out the domestic CIT activity. (10) Due to the specific conditions in the CIT sector, it is difficult to organise safe multi-day euro cash deliveries. It is therefore appropriate that a CIT vehicle carrying out the professional cross-border transport of euro cash by road return to its Member State of origin on the same day. (11) The Commission should put forward a proposal to amend the definition of \u2018daytime\u2019 and/or of the minimum required length of ad-hoc initial training laid down in this Regulation in the event that the social partners at Union level agree that another definition is more appropriate. (12) According to Regulation (EC) No 1072/2009, the number of operations that may be carried out in the host Member State following the international carriage from another Member State is limited to three cabotage operations within 7 days. However, due to the specific characteristics of the CIT sector, it is normal practice for a CIT vehicle to carry out a much larger number of euro cash deliveries/pick-ups per day. It is therefore appropriate to derogate from Regulation (EC) No 1072/2009 by not imposing any limit upon the number of euro cash deliveries/pick-ups that a CIT vehicle may carry out in a host Member State during a single day. (13) National rules governing the behaviour of CIT security staff outside a CIT vehicle and governing the security of euro cash delivery/pick-up locations should not cover the possible use of banknote neutralisation systems in combination with the transport of banknotes in a fully-armoured CIT vehicle not equipped with IBNS. (14) Article 1(3)(a) of Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (5) covers posting situations where an undertaking provides transnational services on its own account and under its direction under a contract concluded between the undertaking and the party for whom the services are intended. (15) Considering the specific nature of CIT transport services, there is a need to provide for the analogous application of Directive 96/71/EC to all cross-border euro cash transport services in order to provide legal certainty for operators and ensure the practical applicability of the Directive in that sector. (16) Due to the specificity of the transport activities concerned and the occasional character of some of those activities, the analogous application of the minimum protection rules laid down in Directive 96/71/EC should be limited to the minimum rates of pay, including overtime rates, as referred to in Article 3(1)(c) of that Directive and these should be guaranteed for the duration of the whole working day in order not to impose an unnecessary administrative burden on the operators. As referred to in Directive 96/71/EC, and within the limits of the case law of the Court of Justice of the European Union, the concept of minimum rates of pay is defined by the national law or practice of the Member State where the worker is posted. Where, as a result of contracts, regulations, administrative provisions or practical arrangements, a CIT worker carries out cross-border transport for more than 100 working days in a calendar year in another Member State, it is appropriate that the minimum protection rules laid down in Directive 96/71/EC apply to such a worker mutatis mutandis. (17) The application of minimum protection rules in the host Member State should be without prejudice to the application of terms and conditions of employment which are more favourable to the worker under the law, collective agreement or employment contract in the worker\u2019s Member State of origin. (18) For the purpose of establishing the relevant minimum protection rules, it is appropriate that the provisions on information cooperation in Article 4 of Directive 96/71/EC apply mutatis mutandis. In this respect, Member States should be able to avail themselves of the administrative cooperation and exchange of information provided for in Directive 96/71/EC. (19) This Regulation is without prejudice to the application of Regulation (EC) No 1889/2005 of the European Parliament and of the Council of 26 October 2005 on controls of cash entering or leaving the Community (6). (20) In order to take into account technological progress and possible new European standards, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of the amendment of the technical rules on standards in regard to the IBNS, the armouring of CIT vehicles, bulletproof vests and weapons strong-boxes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and of the social partners. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (21) In accordance with the principle of proportionality, as set out in Article 5 of the Treaty on European Union, this Regulation does not go beyond what is necessary in order to achieve its objective, namely to facilitate the professional cross-border transport of euro cash by road between euro-area Member States, HAVE ADOPTED THIS REGULATION: SECTION 1 COMMON RULES GOVERNING ALL CROSS-BORDER TRANSPORT OF EURO CASH BY ROAD Article 1 Definitions For the purpose of this Regulation, the following definitions shall apply: (a) \u2018participating Member States\u2019 means those Member States whose currency is the euro; (b) \u2018cross-border transport of euro cash by road\u2019 means the professional transport, either for remuneration on behalf of third parties or carried out within a cash-in-transit (hereinafter \u2018CIT\u2019) company, by a CIT vehicle by road of euro banknotes or coins from a participating Member State, for supplying euro banknotes or coins to, or collecting them from, one or more locations in one or more other participating Member States, and in the Member State of origin \u2013 without prejudice to the transport of a maximum of 20 % of non-euro cash in relation to the total value of cash transported in the same CIT vehicle \u2013 where the majority of euro cash deliveries/pick-ups made by a CIT vehicle during the same day is carried out on the territory of the host Member State, or, in the case of point-to-point transport, where the transport takes place between two different participating Member States; (c) \u2018cross-border CIT licence\u2019 means a licence delivered by the granting authority of the Member State of origin which authorises the holder to carry out the cross-border transport of euro cash by road between participating Member States in accordance with the conditions laid down in this Regulation; (d) \u2018granting authority\u2019 means the authority in the Member State of origin in charge of issuing the cross-border CIT licence; (e) \u2018Member State of origin\u2019 means the participating Member State in whose territory the CIT company is established. The CIT company is considered to be established if it is actually pursuing an economic activity, in accordance with Article 49 TFEU, for an indefinite period, through a stable infrastructure from where the business of providing services is actually carried out; (f) \u2018host Member State\u2019 means one or more participating Member States in which a CIT company provides the service of delivering/picking up euro cash other than its Member State of origin; (g) \u2018Member State of transit\u2019 means one or more participating Member States other than the Member State of origin which the CIT vehicle crosses in order either to reach the host Member State or to return to the Member State of origin; (h) \u2018daytime\u2019, when referring to transport, means transport carried out between 06.00 and 22.00; (i) \u2018CIT security staff\u2019 means the employees instructed to drive the CIT vehicle in which the euro cash is being carried or to protect its contents; (j) \u2018CIT vehicle\u2019 means a vehicle used for the professional transport of euro cash by road; (k) \u2018vehicle of ordinary appearance\u2019 means a CIT vehicle which has a normal appearance and does not bear any distinctive signs indicating that it belongs to a CIT company or that it is used for the purposes of transporting euro cash; (l) \u2018point-to-point transport\u2019 means transport from one secure location to another, without any intermediate stops; (m) \u2018secured area\u2019 means a delivery/pick-up point for euro cash located within a building and secured against unauthorised access in terms of equipment (anti-intrusion systems) and access procedures for persons; (n) \u2018secure location\u2019 means a location within a secured area, which is accessible to CIT vehicles and in which CIT vehicles can be loaded and unloaded in a secure manner; (o) to \u2018neutralise\u2019 a banknote means to mutilate or damage it by staining or by other means as specified in Annex II; (p) \u2018intelligent banknote neutralisation system\u2019 or \u2018IBNS\u2019 means a system that meets the following conditions: (i) the banknote container continuously protects the banknotes by means of a euro cash neutralisation system, from a secured area to the euro cash delivery point or from the euro cash pick-up point to a secured area; (ii) the CIT security staff is not able to open the container outside the pre-programmed time periods and/or locations or to change the pre-programmed time periods and/or locations where the container can be opened once the euro cash transport operation has been initiated; (iii) the container is equipped with a mechanism for permanently neutralising the banknotes if any unauthorised attempt is made to open the container; and (iv) the requirements laid down in Annex II are complied with; (q) \u2018end-to-end IBNS\u2019 means IBNS that is equipped for end-to-end use, namely the banknotes remain inaccessible to CIT security staff at all times and are under continuous protection by the IBNS from secured area to secured area or, for cassettes for Automated Teller Machines (ATMs) or other types of cash dispensers, from a secured area to the interior of the ATMs or the other types of cash dispensers; (r) \u2018A1\u2019 and \u2018B1\u2019, when referring to the level of language skills, mean the levels established by the Council of Europe\u2019s Common European Framework of Reference for Languages, as referred to in Annex VII; (s) \u2018EU official languages\u2019 means the languages referred to in Article 1 of Regulation No 1 determining the languages to be used by the European Economic Community (7). Article 2 Exclusions 1. The transport of euro banknotes and coins shall be excluded from the scope of this Regulation where it is: (a) carried out on the account of, and between, NCBs, or between banknote printing works and/or mints of participating Member States and the relevant NCBs; and (b) escorted by the military or the police. 2. The exclusive transport of euro coins shall be excluded from the scope of this Regulation where it is: (a) carried out on the account of, and between, NCBs, or between mints of participating Member States and the relevant NCBs; and (b) escorted by the military or the police or by private security staff in separate vehicles. Article 3 Place of departure, maximum duration and number of euro cash deliveries/pick-ups 1. Cross-border transport of euro cash provided in accordance with this Regulation shall be carried out during the daytime. 2. A CIT vehicle carrying out cross-border transport of euro cash shall start its journey from its Member State of origin and shall return to it on the same day. 3. By derogation from paragraphs 1 and 2, point-to-point transport may be carried out within a time-slot of 24 hours, provided that night-time transport of euro cash is allowed under national rules of the Member State of origin, of the Member State of transit and of the host Member State. 4. By way of derogation from Regulation (EC) No 1072/2009, there shall be no limit to the number of euro cash deliveries/pick-ups that a CIT vehicle may carry out in a host Member State during the same day. Article 4 Cross-border CIT licence 1. A company wishing to undertake cross-border transport of euro cash by road shall apply for a cross-border CIT licence from the granting authority in its Member State of origin. 2. The cross-border CIT licence shall be granted for a period of 5 years by the national granting authority, provided that the applicant company meets the following conditions: (a) it is approved to carry out CIT transport within its Member State of origin or, if the Member State has no specific approval procedure for CIT companies in addition to its general rules for the security or transport sector, it is able to provide evidence that it has had regular business transporting cash for at least 24 months within its Member State of origin prior to the application with no infringements of that Member State\u2019s national law governing such activities; (b) its managers and the members of its board do not have a relevant entry in a criminal record and are of good repute and integrity, according to, for instance, relevant police records; (c) it has a valid civil liability insurance to cover at least third-party damage to life and property, regardless of whether the cash transported is insured thereunder; (d) the applicant company, its CIT security staff, vehicles and security procedures employed in or applied for the purposes of cross-border transport of euro cash comply with this Regulation or, where expressly referred to in this Regulation, with national law specifically relating to the transport of cash. 3. The cross-border CIT licence shall be drawn up in accordance with the model and the physical characteristics defined in Annex I. CIT security staff in CIT vehicles engaged in the professional cross-border transport of euro cash by road shall, at all times, be able to show the inspection authorities the original or a certified copy of a valid cross-border CIT licence. 4. The cross-border CIT licence shall allow the company to carry out cross-border transport of euro cash under the terms of this Regulation. By way of derogation from Regulation (EC) No 1072/2009, the holder of such a licence shall not be required to possess a Community licence for the international carriage of goods by road. Article 5 CIT security staff 1. All members of the CIT security staff shall satisfy the following requirements: (a) they do not have a relevant entry in a criminal record and are of good repute and integrity according to, for instance, relevant police records; (b) they have a medical certificate certifying that their physical and mental health is adequate for the task to be performed; (c) they have successfully followed at least 200 hours of ad hoc initial training, not including any training on the use of firearms. The minimum requirements for the ad hoc initial training referred to in point (c) are set out in Annex VI. CIT security staff shall follow further training activities in the areas set out in point 3 of Annex VI, at least every 3 years. 2. At least one member of the CIT security staff in the CIT vehicle shall have at least A1-level language skills in the languages used by the local authorities and the population in the relevant areas of the Member State of transit and of the host Member State. The CIT vehicle shall, furthermore, be in constant radio contact, via the CIT company\u2019s control centre, with someone who has at least B1-level language skills in the languages used by the local authorities and the population in the relevant areas of the Member State of transit and of the host Member State, so as to ensure that effective communication with the national authorities is possible at all times. Article 6 Carrying of weapons 1. CIT security staff shall comply with the law of the Member State of origin, of the Member State of transit and of the host Member State as regards the carrying of weapons and the maximum permitted calibre. 2. When entering the territory of a Member State the law of which does not allow CIT security staff to be armed, any weapons in the possession of the CIT security staff shall be placed in an on-board weapons strong-box which meets the European standard EN 1143-1. Such weapons shall remain inaccessible to the CIT security staff throughout the journey across that Member State\u2019s territory. They may be removed from the weapons strong-box when entering the territory of a Member State whose law allows CIT security staff to be armed and shall be removed from it when entering the territory of a Member State whose law requires CIT security staff to be armed. Opening the weapons strong-box shall require remote intervention by the CIT vehicle\u2019s control centre and shall be conditional upon verification by the control centre of the vehicle\u2019s exact geographical location. The requirements set out in the first subparagraph shall also apply if the type or the calibre of the weapon is not allowed under the law of the Member State of transit or of the host Member State. 3. Where a CIT vehicle whose Member State of origin does not allow CIT security staff to carry arms, enters the territory of a Member State whose law requires CIT security staff to carry arms, the CIT company shall ensure that the CIT security staff on board is provided with the required weapons and that they fulfil the minimum training requirements of the host Member State. 4. CIT security staff who are armed or who travel in a CIT vehicle with arms on board shall have a professional weapons licence or authorisation issued by the national authorities of the Member State of transit and/or the host Member State, where those Member States allow CIT security staff to be armed, and fulfil all the national requirements for that professional weapons licence or authorisation. For that purpose, Member States may recognise the professional weapons licence or authorisation of the other Member State. 5. Member States shall establish a single central national contact point to which CIT companies established in other Member States may submit applications for a professional weapons licence or authorisation for their CIT security staff. Federal Member States may establish contact points at State level. Member States shall inform the applicant of the outcome of the application within 3 months from the submission of a complete application file. 6. In order to make it easier for CIT security staff who are employed by a company established in another Member State to fulfil the national requirements for obtaining a professional weapons licence or authorisation, Member States shall provide for validation of equivalent professional weapons training followed in the Member State where the applicant\u2019s employer is established. If this is not possible, Member States shall ensure that the necessary professional weapons training is provided on their own territory in an EU official language which is an official language of the Member State where the applicant\u2019s employer is established. Article 7 CIT vehicle equipment 1. CIT vehicles shall be equipped with a global navigation system. The CIT company\u2019s control centre shall be able continuously and accurately to locate its vehicles. 2. CIT vehicles shall be equipped with appropriate communication tools to allow contact to be made at any time with the control centre of the CIT company operating the vehicles and with the competent national authorities. The emergency numbers to contact the police authorities in the Member State of transit or in the host Member State shall be available in the vehicles. 3. CIT vehicles shall be equipped in a manner that allows the registration of the time and location of all euro cash deliveries/pick-ups in order to make it possible for the proportion of euro cash deliveries/pick-ups referred to in Article 1(b) to be checked at any time. 4. Where CIT vehicles are equipped with IBNS, the IBNS used shall comply with Annex II and shall have been homologated in a participating Member State. In reply to a request for verification made by the authorities of the Member State of origin, the host Member State or the Member State of transit, undertakings carrying out cross-border transport of euro cash in CIT vehicles using IBNS shall supply written evidence of approval of the IBNS model used within 48 hours. Article 8 Role of the national police forces This Regulation is without prejudice to the application of national rules that require: (a) cash-transport operations to be notified to the police in advance; (b) CIT vehicles to be equipped with a device that allows them to be tracked at a remote distance by the police; (c) high-value point-to-point transport to be escorted by the police. Article 9 Rules to ensure the security of the cash delivery/pick-up locations in the host Member State This Regulation is without prejudice to the application of national rules governing the behaviour of CIT security staff outside a CIT vehicle and the security of the locations where cash is delivered/picked up in the Member State concerned. Article 10 Removal of neutralised banknotes from circulation CIT companies operating under this Regulation shall remove from circulation all banknotes that may have been neutralised that they encounter while carrying out their activities. They shall hand over those banknotes to the appropriate NCB branch of their Member State of origin and provide a written statement on the cause and nature of the neutralisation. If those banknotes are collected in a host Member State, the NCB of the host Member State shall be informed by the NCB of the Member State of origin. Article 11 Mutual information 1. Member States shall submit to the Commission the rules referred to in Articles 8 and 9 as well as information on which IBNS have been homologated by them and shall immediately inform the Commission of any change affecting those rules and homologations. The Commission shall ensure that those rules as well as a list of homologated IBNS are published in all the EU official languages which are the official languages of the relevant participating Member States through the appropriate channels, with a view to informing swiftly all the actors involved in a CIT cross-border activity. 2. Member States shall keep a register of all the companies to which they have delivered a cross-border CIT licence and shall inform the Commission about its content. They shall update the register, including in relation to any decision to suspend or withdraw a licence pursuant to Article 22 and shall immediately inform the Commission of such update. To facilitate information-sharing, the Commission shall set up a central secured database containing data on licences issued, suspended or withdrawn, which shall be accessible to the relevant authorities of the participating Member States. 3. In implementing Article 5(1)(a), the Member State of origin shall take due account of information concerning the criminal record, repute and integrity of CIT security staff that is communicated to it by the host Member State. 4. Member States shall inform the Commission about their specific training requirements for CIT security staff for the purpose of the ad-hoc initial training referred to in Article 5(1)(c). The Commission shall ensure that that information is published in all the EU official languages which are the official languages of the relevant participating Member States through the appropriate channels, with a view to informing all the actors involved in a CIT cross-border activity. 5. Member States shall inform the Commission of the addresses and other contact details of the national contact points referred to in Article 6(5) and of relevant national law. The Commission shall ensure that this information is published through the appropriate channels, with a view to informing all the actors involved in a CIT cross-border activity. 6. Where a Member State withdraws the professional weapons licence or authorisation that it has delivered to a member of the CIT security staff of a company established in another Member State, it shall inform the granting authority of the Member State of origin thereof. 7. Member States shall inform the Commission of the addresses and other contact details of the relevant authorities referred to in Article 12(2). The Commission shall ensure that this information is published through the appropriate channels, with a view to informing all the actors involved in a CIT cross-border activity. Article 12 Information prior to the start of cross-border transport 1. A company holding or having submitted an application for a cross-border CIT licence shall inform the granting authority at least 2 months before it begins its cross-border activity of the Member States in which it will carry out CIT transport. The Member State of origin shall subsequently immediately notify the Member States concerned that the cross-border activity is to start. 2. A company that intends to carry out cross-border cash transport shall provide in advance the relevant authority or authorities indicated by the host Member State with information on the type or types of transport it will use, the names of the persons who may carry out such transport and the type of any weapons carried. SECTION 2 SPECIFIC RULES FOR EACH TYPE OF TRANSPORT Article 13 Applicable transport arrangements 1. With respect to the cross-border transport of euro banknotes by road carried out on its territory, each Member State shall allow: (a) at least one of the options laid down in Article 14, 15, 16, 17 or 18; and (b) those options laid down in Articles 14, 15, 16, 17 and 18 that are comparable to the transport arrangements allowed for domestic CIT transport. Article 17 shall apply to all Member States as regards point-to-point transport. 2. With respect to the cross-border transport of euro coins by road carried out on its territory, each Member State shall allow: (a) at least one of the options laid down in Article 19 or 20; and (b) those options laid down in Articles 19 and 20 that are comparable to the transport arrangements allowed for domestic CIT transport. 3. Transport which includes both euro banknotes and coins shall be covered by the transport arrangements for the cross-border transport of euro banknotes. 4. As regards the application of Articles 14, 15, 16 and 18, a Member State may decide that only end-to-end IBNS may be used on its territory for the servicing of off-premises ATMs or other types of off-premises cash dispensers, provided that the same rules apply for domestic CIT transport. 5. Participating Member States shall notify the Commission of the transport arrangements which are applicable in accordance with this Article. The Commission shall publish a corresponding information notice in the Official Journal of the European Union. The applicable transport arrangements shall take effect 1 month after publication of the information notice. Participating Member States shall use the same procedure when new transport arrangements become applicable pursuant to this Article. 6. If a host Member State or a Member State of transit finds that an IBNS displays serious deficiencies as regards the technical characteristics normally required, namely that the cash can be accessed without triggering the neutralisation mechanism or the IBNS has been modified after homologation in such a way that it no longer fulfils the homologation criteria, it shall inform the Commission and the Member State that granted the homologation and may ask that new tests be carried out on that IBNS. Pending the results of those new tests, Member States may provisionally prohibit the use of that IBNS on their territory. They shall, without delay, inform the Commission and the other participating Member States thereof. Article 14 Transport of banknotes in an unarmoured CIT vehicle of ordinary appearance equipped with IBNS Companies holding a cross-border CIT licence may carry out cross-border transport of euro banknotes by road using an unarmoured CIT vehicle equipped with IBNS, provided that the following conditions are met: (a) the vehicle is of ordinary appearance; (b) there are at least two CIT security staff per vehicle; (c) none of the CIT security staff wears a uniform. Article 15 Transport of banknotes in an unarmoured CIT vehicle with a clear marking indicating that it is equipped with IBNS Companies holding a cross-border CIT licence may carry out cross-border transport of euro banknotes by road using an unarmoured CIT vehicle equipped with IBNS, provided that the following conditions are met: (a) the vehicle and banknote containers bear very clear markings indicating that they are equipped with IBNS and those markings correspond to the pictograms depicted in Annex III; (b) there are at least two CIT security staff per vehicle. Article 16 Transport of banknotes in a cabin-armoured CIT vehicle equipped with IBNS Companies holding a cross-border CIT licence may carry out cross-border transport of euro banknotes by road using a cabin-armoured CIT vehicle equipped with IBNS, provided that the following conditions are met: (a) the cabin of the vehicle is armoured to withstand at least gunfire from firearms in accordance with the specifications set out in Annex V; (b) the vehicle and banknote containers bear very clear markings indicating that they are equipped with IBNS and those markings correspond to the pictograms depicted in Annex III; (c) the cabin of the vehicle is equipped with a bulletproof vest for each member of the CIT security staff on board, at least respecting the norm VPAM class 5, NIJ IIIA or an equivalent standard; (d) there are at least two CIT security staff per vehicle. The CIT security staff may wear the bulletproof vests referred to in point (c) during the transport and shall wear them where required by the law of the Member State where they are situated. Article 17 Transport of banknotes in a fully-armoured CIT vehicle not equipped with IBNS Companies holding a cross-border CIT licence may carry out cross-border transport of euro banknotes by road using a fully-armoured CIT vehicle not equipped with IBNS, provided that the following conditions are met: (a) the parts of the vehicle in which the CIT security staff are present are armoured to withstand at least gunfire from firearms in accordance with the specifications set out in Annex V; (b) the cabin of the vehicle is equipped with a bulletproof vest for each member of the CIT security staff on board, at least respecting the norm VPAM class 5, NIJ IIIA or an equivalent standard; (c) there are at least three CIT security staff per vehicle. The CIT security staff may wear the vests referred to in point (b) during the transport and shall wear them where required by the law of the Member State where they are situated. Article 18 Transport of banknotes in a fully-armoured CIT vehicle equipped with IBNS Companies holding a cross-border CIT licence may carry out cross-border transport of euro banknotes by road using a fully-armoured CIT vehicle equipped with IBNS, in accordance with Article 16(b) and Article 17(a) and (b). There shall be at least two CIT security staff per vehicle. Article 19 Transport of coins in an unarmoured CIT vehicle Companies holding a cross-border CIT licence may carry out cross-border transport of euro coins by road using an unarmoured CIT vehicle carrying only coins, provided that the following conditions are met: (a) the vehicle is of ordinary appearance; (b) there are at least two CIT security staff per vehicle; (c) none of the CIT security staff wears a uniform. Article 20 Transport of coins in a cabin-armoured CIT vehicle Companies holding a cross-border CIT licence may carry out cross-border transport of euro coins by road using a cabin-armoured CIT vehicle carrying only coins, provided that the following conditions are met: (a) the cabin of the vehicle is armoured to withstand at least gunfire from firearms in accordance with the specifications set out in Annex V; (b) the vehicle bears very clear markings indicating that it is carrying only coins and those markings correspond to the pictogram depicted in Annex IV; (c) the cabin of the vehicle is equipped with a bulletproof vest for each member of the CIT security staff on board, at least respecting the norm VPAM class 5, NIJ IIIA or an equivalent standard; (d) there are at least two CIT security staff per vehicle. The CIT security staff may wear the bulletproof vests referred to in point (c) during the transport and shall wear them where required by the law of the Member State where they are situated. SECTION 3 FINAL PROVISIONS Article 21 Compliance During the period of validity of a cross-border CIT licence, Member States of origin shall ensure that the rules laid down in this Regulation are complied with, including via random inspections without prior notification to the company. Such inspections may also be carried out by host Member States. Article 22 Penalties 1. Where the competent national authorities find that there has been an infringement of one of the terms under which the cross-border CIT licence was granted, the granting authority may send a warning to the company concerned, impose a fine, suspend the licence for a period ranging from 2 weeks to 2 months or withdraw the licence completely, depending on the nature or severity of the infringement. The granting authority may also prohibit the company concerned from applying for a new licence for a period of up to 5 years. 2. The Member State of transit or the host Member State shall communicate any infringement of this Regulation \u2013 including infringements of the national rules referred to in Articles 8 and 9 \u2013 to the competent national authorities of the Member State of origin, which shall decide on an appropriate penalty. The Member State of transit or the host Member State may furthermore impose a fine in case of infringement of the national rules referred to in Articles 8 and 9 or of the applicable transport arrangements referred to in Article 13. It may prohibit CIT security staff that have committed such infringements from carrying out cross-border cash transport on its territory if the infringement can be imputed to them. 3. The Member State of transit or the host Member State may suspend the right of a CIT company to transport euro cash by road on its territory for a maximum period of 2 months, pending a decision by the granting authority of the Member State of origin which shall be taken within that same period, where the CIT company: (a) has not complied with the provisions of this Regulation relating to the minimum number of CIT security staff per CIT vehicle or relating to weapons; (b) carries out its transport activity in a way that constitutes a danger to public order; or (c) has committed repeated infringements of this Regulation. 4. The Member State that issued the professional weapons licence or authorisation may impose penalties on the CIT security staff in accordance with its national rules in case of infringement of its national weapons law. 5. The penalties shall be proportionate to the severity of the infringement. Article 23 Emergency security measures 1. A Member State may decide to introduce temporary security measures going beyond those provided for in this Regulation in the event of an urgent problem affecting significantly the security of CIT operations. Such temporary measures shall affect all CIT transport in all or part of the national territory, shall apply for a maximum period of 4 weeks and shall be notified immediately to the Commission. The Commission shall ensure their swift publication through the appropriate channels. 2. The prolongation of the temporary measures provided for in paragraph 1 beyond a period of 4 weeks shall be subject to prior authorisation by the Commission. The Commission shall decide whether to grant such prior authorisation within 72 hours of receipt of a request. Article 24 Remuneration of CIT security staff carrying out cross-border transport CIT security staff carrying out cross-border transport in accordance with this Regulation shall be guaranteed the relevant minimum rates of pay, including overtime rates, in the host Member State in accordance with Article 3(1)(c) of Directive 96/71/EC. If the relevant minimum rates of pay in the host Member State are higher than the wage paid to the employee in the Member State of origin, the relevant minimum rates of pay, including overtime rates, of the host Member State shall apply for the whole working day. If transport is carried out in more than one host Member State during the same day and more than one of those Member States have higher relevant minimum rates of pay than the wage applied in the Member State of origin, the highest of those minimum rates of pay, including overtime rates, shall apply for the whole working day. However, where, as a result of contracts, regulations, administrative provisions or practical arrangements, a CIT worker carries out cross-border transport for more than 100 working days, wholly or partially spent in a calendar year in another Member State, the terms and conditions of employment referred to in Directive 96/71/EC shall be applied fully for all the working days spent wholly or partially in that host Member State in that calendar year. For the purpose of establishing the relevant terms and conditions of employment, Article 4 of Directive 96/71/EC shall apply mutatis mutandis. Article 25 Committee on the cross-border transport of euro cash 1. A Committee on the cross-border transport of euro cash shall be established. It shall be chaired by the Commission and gather two representatives per participating Member State, together with two representatives of the European Central Bank. 2. The Committee shall meet at least once a year to exchange views on the implementation of this Regulation. For this purpose, it shall consult the stakeholders in the sector, including the social partners, and take their views into account as appropriate. It shall be consulted on the preparation of the review referred to in Article 26. Article 26 Review By 1 December 2016 and every 5 years thereafter, the Commission shall report to the European Parliament and to the Council on the implementation of this Regulation. For that purpose, it shall consult the stakeholders in the sector including the social partners followed by the Member States. The report shall, in particular, examine the possibility of establishing common training requirements for the carrying of arms by CIT -security staff and of amending Article 24 in the light of Directive 96/71/EC, take due account of technological progress in the area of IBNS, consider the potential added value of granting Union CIT licences on a group basis and assess whether this Regulation needs to be revised accordingly. Article 27 Amendment of technical rules The Commission shall be empowered to adopt delegated acts in accordance with Article 28 concerning amendments to Annex II and to the technical rules on the standards applicable to the armouring of CIT vehicles and to bulletproof vests referred to in Articles 16, 17, 18 and 20, and to weapons strong-boxes referred to in Article 6(2), with a view to taking into account technological progress and possible new European standards. Article 28 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 27 shall be conferred on the Commission for an indeterminate period of time from 30 November 2012. 3. The delegation of power referred to in Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified therein. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 27 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 3 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or of the Council. Article 29 Entry into force This Regulation shall enter into force 12 months after its publication in the Official Journal of the European Union. It shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 16 November 2011. For the European Parliament The President J. BUZEK For the Council The President W. SZCZUKA (1) OJ C 278, 15.10.2010, p. 1. (2) Position of the European Parliament of 27 September 2011 (not yet published in the Official Journal) and decision of the Council of 27 October 2011. (3) OJ L 376, 27.12.2006, p. 36. (4) OJ L 300, 14.11.2009, p. 72. (5) OJ L 18, 21.1.1997, p. 1. (6) OJ L 309, 25.11.2005, p. 9. (7) OJ 17, 6.10.1958, p. 385. ANNEX I MODEL FOR CROSS-BORDER CIT LICENCE ANNEX II INTELLIGENT BANKNOTE NEUTRALISATION SYSTEM (IBNS) I. Definitions and general provisions An IBNS may contain either banknotes (packaged or unpackaged) or one or several cassettes for ATMs or other types of cash dispensers. An IBNS must have been homologated in a participating Member State in order to be used for cross-border transport of euro cash under this Regulation. The homologation must be made according to an existing European specific standard. As long as there is no such standard, the homologation must be made in accordance with this Annex. II. IBNS approval procedure (a) In order to be homologated, the IBNS must have passed various tests in a test laboratory that has been approved or recognised by a participating Member State. It must furthermore be accompanied by instructions for its use, which indicate the operating procedures and conditions that ensure the effectiveness of the destruction or neutralisation of the banknotes. These tests must make it possible to ascertain that the following technical characteristics of the IBNS are satisfactory: (i) Main required functions of the monitoring system \u2014 permanently to monitor and record the instructions concerning the conditions for access to, and use of, the IBNS, \u2014 continuously to verify compliance with these instructions and detect anomalous situations, \u2014 automatically and immediately to neutralise the banknotes in the event of non-compliance with the instructions, detection of anomalous situations or opening of the container outside the pre-programmed time periods and/or locations. (ii) Location where the monitoring system may be programmed and influence of CIT security staff on how the IBNS operates An IBNS must be programmed only in a secured area. An end-to-end IBNS must only be programmed in a secure location. CIT security staff must not have any means whatsoever of influencing the operation of the IBNS outside the pre-programmed time periods and/or locations. However, where there is a time-delay system for triggering the neutralisation, the CIT security staff may re-initiate the time delay once. (iii) Location where the IBNS may be opened (for end-to-end systems) An IBNS must only be opened in the pre-programmed destinations. (b) The IBNS must be retested every 5 years, even where the national approval is issued for an unlimited period. If the new tests are not conclusive, the homologation ceases to be valid for cross-border transport under this Regulation. (c) In order to pass the tests, one of the following results must be achieved upon performance of the tests: \u2014 it was not possible to access the banknotes and there was no damage to the IBNS, the mechanism of which remained operational, or \u2014 the IBNS was damaged but it was not possible to access the banknotes without triggering the neutralisation system. III. Testing procedures The method used to carry out the tests and the standards establishing the result which the systems tested must achieve are laid down in this Annex. However, adjustments may be made at national level so as to bring them into line with the existing test protocols followed by the laboratories in each Member State. In order for the IBNS to be homologated, the IBNS-manufacturer must ensure that the results of the testing procedures in this Annex are transmitted to the homologating authority. (a) Test of IBNS\u2019 resistance to different attack scenarios Member States must carry out six of the various tests simulating attack scenarios, while the other tests may also be carried out in accordance with the applicable national rules. For each of the tests carried out, the result must be a pass within the meaning of point II(c): \u2014 compulsory tests: 1. cutting of the power supply; 2. breaking into the container; 3. opening the container by destructive means (e.g. sledgehammer); 4. rapid cutting (\u2018guillotining\u2019); 5. immersion in liquid; 6. gradual and immediate exposure to extreme temperatures (hot and cold): e.g. cooling in liquid nitrogen and heating in a preheated oven, \u2014 recommended tests that may also be carried out: 7. resistance to firearms (e.g. with 12-bore cartridges); 8. use of chemicals; 9. free drop; 10. exposure to significant electromagnetic surges; 11. exposure to significant electrostatic surges. (b) Effectiveness of neutralisation of banknotes The neutralisation processes currently used are staining, chemical destruction and pyrotechnical destruction. Since technological developments may occur, the list of processes used is non-exhaustive and purely indicative. Following any unauthorised attempt to access the banknotes via the various forms of attack, the banknotes must be either destroyed or stained. A minimum of three tests must be carried out. 100 % of the banknotes must be irreversibly neutralised. It must furthermore be apparent for any holder of the banknotes that they have been subject to neutralisation. A minimum of 10 % of the surface area of both sides of each banknote must be stained if the banknotes are in safe-bags. If the banknotes are not in safe-bags, a minimum of 20 % of the surface area of both sides of each banknote must be stained. For destruction systems, a minimum of 20 % of the surface area of each banknote must be destroyed in both cases. (c) Content of the tests for banknotes\u2019 resistance to cleaning \u2013 for IBNS using staining For such \u2018cleaning\u2019, use must be made of different products or combinations of products. Different scenarios must be arranged so as to vary the temperature and duration of cleaning. Two procedures must be used for these cleaning tests: \u2014 cleaning must be carried out immediately after staining, and \u2014 cleaning must be carried out 24 hours after staining, These tests must be carried out on a representative sample of real banknotes used in the euro area. One of the following results must be obtained at the end of these tests: \u2014 the cleaning leads to destruction of the banknotes, \u2014 the cleaning leaves ink visible on a surface area of at least 10 % of each banknote (density test of the ink used), \u2014 the cleaning leads to the mutilation of both the banknote's original colours and its security features. IV. Safety guarantees for the systems used Chemical substances released from IBNS in order to neutralise banknotes may be subject to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (1). That Regulation addresses risks to human health and the environment of substances manufactured, imported or used on their own, in a mixture, or in an article. In order for the IBNS to be homologated, the manufacturer must verify whether it has to register or notify substances contained in its products or to communicate information on safe use to its customers. The manufacturer may also have legal obligations resulting from the inclusion of these substances in the candidate list of substances of very high concern or in the list of substances subject to authorisation set out in Regulation (EC) No 1907/2006. These obligations refer not only to the listed substances on their own or in mixtures, but also to their presence in articles. A certificate must be supplied to the homologating authority of the Member State by the IBNS manufacturer, which includes the results of this verification and which lists the substances or elements used to ensure destruction or neutralisation of the banknotes and attests that they do not pose a serious risk to health in the case of inhalation by, or contact with, the skin of the CIT security staff or of the NCB staff. The certificate must furthermore indicate possible precautionary measures to be taken. The homologating authority must transmit the certificate to the NCBs of the participating Member States with respect to IBNS homologated by it. To this effect, the certificate may include an analysis of the risks of exposure to the chemicals, i.e. maximum permissible duration of exposure for a quantity to be determined. (1) OJ L 396, 30.12.2006, p. 1. ANNEX III IBNS PICTOGRAMS Pictogram for CIT vehicles equipped with IBNS Pictogram for banknote containers equipped with IBNS ANNEX IV PICTOGRAM FOR CIT VEHICLES CARRYING EXCLUSIVELY COINS ANNEX V ARMOURING SPECIFICATIONS The minimum armouring requirement referred to in Section 2 of this Regulation means that the armouring of the CIT vehicle is able to resist gunfire from a rifle of Kalashnikov type with a calibre of 7,62 mm \u00d7 39 mm using full steel jacket (plated) iron core ammunition with a mass of 7,97 grams (+/\u2013 0,1 gram) with a velocity of at least 700 metres/second at a firing distance of 10 metres (+/\u2013 0,5 metres). ANNEX VI MINIMUM REQUIREMENTS OF INITIAL TRAINING FOR CIT SECURITY STAFF THAT CARRY OUT CROSS-BORDER EURO CASH TRANSPORT CIT workers taking part in professional cross-border transport of euro cash by road between Member States in the euro area must: (1) fully follow and complete at least the appropriate initial training as provided by their national regulations of reference and/or the relevant collective labour agreements or, in the absence thereof, the national CIT/security association's or internal company's training courses; (2) successfully pass the examinations following this initial training or any procedure aimed at testing the learning outcome; (3) fully follow and complete the additional and obligatory training module as provided for in this Annex consisting of at least: \u2014 cross-border CIT procedures, \u2014 Union law on CIT, \u2014 applicable national law covering CIT of the Member States of transit and the host Member States, \u2014 driving rules for CIT in the Member States of transit and the host Member States (including right for CIT vehicles to use specific driving lanes), \u2014 national security protocols in case of attack in the Member States of transit and the host Member States, \u2014 organisation and operating procedures of CIT transport protected by IBNS technology of the Member States of transit and the host Member States, \u2014 applicable national operational protocols, rules and regulations of the Member States of transit and the host Member States, \u2014 national protocols in case of emergency of the Member States of transit and the host Member States in case of breakdown, road accidents, and technical and mechanical failures of any CIT equipment and vehicle, \u2014 national administrative procedures and company rules within the Member States of transit and the host Member States regarding communication with the control point etc. of all Member States transited and of all host Member States, \u2014 information and training regarding cooperation and appropriate protocols with national, regional and local police forces including with regards to checks carried out on CIT vehicles and security staff, \u2014 applicable national and Union law and/or applicable collective agreements regarding working time, number of breaks necessary, working conditions, wages applicable, \u2014 applicable national and Union law and/or applicable collective agreement stipulations regarding CIT security staff rest periods \u2013 when needed, how often, duration of each break period, secure location, communication with control centres, etc., \u2014 applicable security rules for deliveries/pick-ups (secure location, pavement risk management etc.), \u2014 national law of reference regarding the use of weapons and their storage, \u2014 offensive and defensive driving techniques, \u2014 relevant training on the use of GPS, telephone and other technical equipment/systems used in cross-border CIT transport, \u2014 national health and safety regulation in the Member States of transit and the host Member States relevant for workers transporting valuables and travelling with large vehicles by road and protocols in case of injury or sickness of employees, \u2014 first aid training. The training must furthermore include the following items: \u2014 preventive and remedial measures in the areas of stress management and third party violence, \u2014 risk assessment at work, \u2014 language training as necessary to fulfil the language requirements set out in Article 5(2). ANNEX VII COUNCIL OF EUROPE\u2019S COMMON EUROPEAN FRAMEWORK OF REFERENCE FOR LANGUAGES: LEVELS User B1: Can understand the main points of clear standard input on familiar matters regularly encountered in work, school, leisure, etc. Can deal with most situations likely to arise whilst travelling in an area where the language is spoken. Can produce simple connected text on topics which are familiar or of personal interest. Can describe experiences and events, dreams, hopes & ambitions and briefly give reasons and explanations for opinions and plans. User A1: Can understand and use familiar everyday expressions and very basic phrases aimed at the satisfaction of needs of a concrete type. Can introduce him/herself and others and can ask and answer questions about personal details such as where he/she lives, people he/she knows and things he/she has. Can interact in a simple way provided the other person talks slowly and clearly and is prepared to help.", "summary": "Cross-border transportation of euro cash by road Cross-border transportation of euro cash by road SUMMARY OF: Regulation (EU) No 1214/2011 \u2014 rules on the professional cross-border transport of euro cash by road between euro-area countries WHAT IS THE AIM OF THIS REGULATION? The aim is twofold: to ensure a more level-playing field for cash-intransit (CIT) companies providing transportation of euro cash by road in the euro area; to ensure that the professional transport of euro cash by road between countries belonging to the euro area is competitive, secure and safe for both the staff concerned and the general public. KEY POINTS Rationale and scope The introduction of the euro has increased the need for the cross-border transport of cash by road in euro area countries. Banks, the retail sector and other professional cash handlers should be able to contract with CIT companies offering the best price and/or service. They should also be entitled to take advantage of the cash services of the nearest national central bank branch or CIT cash centre, even if it is located in another euro-area country. Euro-area countries (\u2018participating countries\u2019) also have the right to arrange for euro banknotes and coins to be produced abroad. Retailers and banks located in border areas may wish to obtain their supplies from the cash centre nearest to them, which is not necessarily in the same EU country. The very principle of a single currency implies the freedom to move cash between participating euro-area countries. A full harmonisation of CIT transport in participating EU countries was not considered feasible, nor was a system considered appropriate where authorisation in one EU country would be valid in all EU countries (\u2018mutual recognition\u2019). Therefore, Regulation (EU) No 1214/2011 lays down a set of common rules valid in all EU countries, without prejudice to national rules for certain aspects explicitly indicated in the regulation. It does not involve full harmonisation, as the common rules only apply to cross-border transport. Cross-border CIT licence Given the potential threats, associated with the activity of transporting cash, to the security of the staff of CIT companies and the general public, the cross-border transport of euro cash is subject to holding a specific cross-border CIT licence. National authorities grant this licence for a period of 5 years if CIT companies meet certain conditions, such as requirements for security staff or for vehicles. The CIT licences are registered in the EU\u2019s Internal Market Information System to allow public authorities to easily access them. Staff carrying out cross-border CIT are entitled to the minimum rates of pay that apply in the host countries. Cross-border transport of euro cash The cross-border CIT licence grants the holder the right to transport euro banknotes and coins across borders by road, during daylight hours and only if both the majority of the pick-up or of the delivery is in the host country and the value of euro cash is at least 80 % of the total cash value transported in the vehicle. Some specific transport arrangements are explicitly exempted from the scope of the regulation, such as point-to-point transports to and from national central banks or cash production sites. Transport arrangements The regulation provides for 5 types of transport arrangements for euro banknotes and 2 types for euro coins. It defines the conditions of each, such as: vehicle armouring; the use of intelligent banknote neutralisation systems (IBNS); the presence of CIT security staff. The participating countries decide which transport arrangements apply in their territory. Role of IBNS and removal of neutralised banknotes The regulation seeks to facilitate the use of IBNS so as to improve the security of CIT security staff and the public. CIT companies must remove neutralised banknotes (banknotes rendered unusable to protect them against unauthorised access) from circulation so that they are no longer used for payment. Host country rules applying to transport: national police force, public security and carrying of firearms CIT aspects not covered by the common rules of the regulation are governed by national law, subject to the general rules of the treaty (such as the principle of non-discrimination), and must be respected in the host country by the CIT company carrying out the cross-border transport. These national rules concern: the role of the police force (such as prior notification, escorting or distant remote tracking); security rules on cash delivery or pick-up at locations; and rules on firearms. Notification and information Licence holders must inform the participating country of the intended start of cross-border transport. Participating countries must inform each other of cross-border business notified by the CIT companies. On the Europa website, the European Commission publishes all information on: IBNS approved by participating countries;national rules on the role of police forces and on the security of locations where the cash is delivered or picked up from;national CIT training requirements;the credentials of the national granting authority; andthe host administration that has to be notified about the start of cross-border transport. The Commission publishes the applicable transport arrangements as chosen by the participating countries in the Official Journal of the European Union. Compliance checks, penalties and emergency security measures Participating countries carry out compliance checks on CIT companies acting in their territory. Penalties can be applied in cases of non-compliance. Competent authorities may introduce temporary security measures in the event of an urgent problem significantly affecting the security of CIT operations. Review Every 5 years, the Commission reports to the European Parliament and the Council on the regulation\u2019s implementation. FROM WHEN DOES THE REGULATION APPLY? It has applied since 29 November 2012. BACKGROUND For more information, see: Common EU rules for professional cross-border transportation of euro cash by road (European Commission). MAIN DOCUMENT Regulation (EU) No 1214/2011 of the European Parliament and of the Council of 16 November 2011 on the professional cross-border transport of euro cash by road between euro-area Member States (OJ L 316, 29.11.2011, pp. 1-20) RELATED DOCUMENTS Applicable transport arrangements in the euro-area Member States (Article 13(5)) and in Andorra, Monaco, San Marino and the Vatican (Regulation (EU) No 1214/2011 of the European Parliament and of the Council on the cross-border transport of euro cash by road between euro-area Member States) (OJ C 139, 4.5.2017, pp. 14-23) Report from the Commission to the European Parliament and the Council on the implementation of Regulation (EU) No 1214/2011 of the European Parliament and of the Council of 16 November 2011 on the professional cross-border transport of euro cash by road between euro-area Member States pursuant to Article 26 of this regulation (COM(2017) 5 final, 11.1.2017) Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (OJ L 18, 21.1.1997, pp. 1-6) last update 01.03.2018"}
{"article": "22.11.2011 EN Official Journal of the European Union L 304/18 REGULATION (EU) No 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Article 169 of the Treaty on the Functioning of the European Union (TFEU) provides that the Union is to contribute to the attainment of a high level of consumer protection by the measures it adopts pursuant to Article 114 thereof. (2) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests. (3) In order to achieve a high level of health protection for consumers and to guarantee their right to information, it should be ensured that consumers are appropriately informed as regards the food they consume. Consumers\u2019 choices can be influenced by, inter alia, health, economic, environmental, social and ethical considerations. (4) According to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (3) it is a general principle of food law to provide a basis for consumers to make informed choices in relation to food they consume and to prevent any practices that may mislead the consumer. (5) Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (4) covers certain aspects of the provision of information to consumers specifically to prevent misleading actions and omissions of information. The general principles on unfair commercial practices should be complemented by specific rules concerning the provision of food information to consumers. (6) Union rules on food labelling applicable to all foods are laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (5). The majority of the provisions laid down in that Directive date back to 1978 and should therefore be updated. (7) Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs (6) lays down rules on the content and presentation of nutrition information on prepacked foods. According to those rules, the inclusion of nutrition information is voluntary unless a nutrition-related claim is made concerning the food. The majority of the provisions laid down in that Directive date back to 1990 and should therefore be updated. (8) The general labelling requirements are complemented by a number of provisions applicable to all foods in particular circumstances or to certain categories of foods. In addition, there are a number of specific rules which are applicable to specific foods. (9) While the original objectives and the core components of the current labelling legislation are still valid, it is necessary to streamline it in order to ensure easier compliance and greater clarity for stakeholders and to modernise it in order to take account of new developments in the field of food information. This Regulation will both serve the interests of the internal market by simplifying the law, ensuring legal certainty and reducing administrative burden, and benefit citizens by requiring clear, comprehensible and legible labelling of foods. (10) The general public has an interest in the relationship between diet and health and in the choice of an appropriate diet to suit individual needs. The Commission White Paper of 30 May 2007 on a Strategy for Europe on Nutrition, Overweight and Obesity related health issues (the \u2018Commission White Paper\u2019) noted that nutrition labelling is one important method of informing consumers about the composition of foods and of helping them to make an informed choice. The Commission Communication of 13 March 2007 entitled \u2018EU Consumer Policy strategy 2007-2013 \u2014 Empowering consumers, enhancing their welfare, effectively protecting them\u2019 underlined that allowing consumers to make an informed choice is essential both to effective competition and consumer welfare. Knowledge of the basic principles of nutrition and appropriate nutrition information on foods would contribute significantly towards enabling the consumer to make such an informed choice. Education and information campaigns are an important mechanism for improving consumer understanding of food information. (11) In order to enhance legal certainty and ensure rationality and consistency of enforcement, it is appropriate to repeal Directives 90/496/EEC and 2000/13/EC and to replace them by a single regulation which ensures certainty for consumers and other stakeholders and reduces the administrative burden. (12) For the sake of clarity, it is appropriate to repeal and include in this Regulation other horizontal acts, namely Commission Directive 87/250/EEC of 15 April 1987 on the indication of alcoholic strength by volume in the labelling of alcoholic beverages for sale to the ultimate consumer (7), Commission Directive 1999/10/EC of 8 March 1999 providing for derogations from the provisions of Article 7 of Council Directive 79/112/EEC as regards the labelling of foodstuffs (8), Commission Directive 2002/67/EC of 18 July 2002 on the labelling of foodstuffs containing quinine, and of foodstuffs containing caffeine (9), Commission Regulation (EC) No 608/2004 of 31 March 2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters (10) and Commission Directive 2008/5/EC of 30 January 2008 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Directive 2000/13/EC of the European Parliament and of the Council (11). (13) It is necessary to set common definitions, principles, requirements and procedures so as to form a clear framework and a common basis for Union and national measures governing food information. (14) In order to follow a comprehensive and evolutionary approach to the information provided to consumers relating to food they consume, there should be a broad definition of food information law covering rules of a general and specific nature as well as a broad definition of food information covering information provided also by other means than the label. (15) Union rules should apply only to undertakings, the concept of which implies a certain continuity of activities and a certain degree of organisation. Operations such as the occasional handling and delivery of food, the serving of meals and the selling of food by private persons, for example at charity events, or at local community fairs and meetings, should not fall within the scope of this Regulation. (16) Food information law should provide sufficient flexibility to be able to keep up to date with new information requirements of consumers and ensure a balance between the protection of the internal market and the differences in the perception of consumers in the Member States. (17) The prime consideration for requiring mandatory food information should be to enable consumers to identify and make appropriate use of a food and to make choices that suit their individual dietary needs. With this aim, food business operators should facilitate the accessibility of that information to the visually impaired. (18) In order to enable food information law to adapt to consumers\u2019 changing needs for information, any considerations about the need for mandatory food information should also take account of the widely demonstrated interest of the majority of consumers in the disclosure of certain information. (19) New mandatory food information requirements should however only be established if and where necessary, in accordance with the principles of subsidiarity, proportionality and sustainability. (20) Food information law should prohibit the use of information that would mislead the consumer in particular as to the characteristics of the food, food effects or properties, or attribute medicinal properties to foods. To be effective, that prohibition should also apply to the advertising and presentation of foods. (21) In order to prevent a fragmentation of the rules concerning the responsibility of food business operators with respect to food information it is appropriate to clarify the responsibilities of food business operators in this area. That clarification should be in accordance with the responsibilities regarding the consumer referred to in Article 17 of Regulation (EC) No 178/2002. (22) A list should be drawn up of all mandatory information which should in principle be provided for all foods intended for the final consumer and mass caterers. That list should maintain the information that is already required under existing Union legislation given that it is generally considered as a valuable acquis in respect of consumer information. (23) In order to take account of changes and developments in the field of food information, provisions should be made to empower the Commission to enable certain particulars to be made available through alternative means. Consultation with stakeholders should facilitate timely and well-targeted changes of food information requirements. (24) When used in the production of foods and still present therein, certain ingredients or other substances or products (such as processing aids) can cause allergies or intolerances in some people, and some of those allergies or intolerances constitute a danger to the health of those concerned. It is important that information on the presence of food additives, processing aids and other substances or products with a scientifically proven allergenic or intolerance effect should be given to enable consumers, particularly those suffering from a food allergy or intolerance, to make informed choices which are safe for them. (25) In order to inform consumers of the presence of engineered nanomaterials in food, it is appropriate to provide for a definition of engineered nanomaterials. Taking into account the possibility of food containing or consisting of engineered nanomaterials being a novel food, the appropriate legislative framework for that definition should be considered in the context of the upcoming review of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (12). (26) Food labels should be clear and understandable in order to assist consumers who want to make better-informed food and dietary choices. Studies show that easy legibility is an important element in maximising the possibility for labelled information to influence its audience and that illegible product information is one of the main causes of consumer dissatisfaction with food labels. Therefore, a comprehensive approach should be developed in order to take into account all aspects related to legibility, including font, colour and contrast. (27) In order to ensure the provision of food information, it is necessary to consider all ways of supplying food to consumers, including selling food by means of distance communication. Although it is clear that any food supplied through distance selling should meet the same information requirements as food sold in shops, it is necessary to clarify that in such cases the relevant mandatory food information should also be available before the purchase is concluded. (28) The technology used in the freezing of foods has developed significantly during recent decades and has become widely used both to improve the circulation of goods on the Union internal market, and to reduce food safety risks. However, the freezing and later defrosting of certain foods, especially meat and fishery products, limits their possible further use and may also have an effect on their safety, taste and physical quality. Conversely, for other products, especially butter, freezing has no such effects. Therefore, where a product has been defrosted, the final consumer should be appropriately informed of its condition. (29) The indication of the country of origin or of the place of provenance of a food should be provided whenever its absence is likely to mislead consumers as to the true country of origin or place of provenance of that product. In all cases, the indication of country of origin or place of provenance should be provided in a manner which does not deceive the consumer and on the basis of clearly defined criteria which ensure a level playing field for industry and improve consumers\u2019 understanding of the information related to the country of origin or place of provenance of a food. Such criteria should not apply to indications related to the name or address of the food business operator. (30) In some cases, food business operators may want to indicate the origin of a food on a voluntary basis to draw consumers\u2019 attention to the qualities of their product. Such indications should also comply with harmonised criteria. (31) The indication of origin is currently mandatory for beef and beef products (13) in the Union following the bovine spongiform encephalopathy crisis and it has created consumer expectations. The impact assessment of the Commission confirms that the origin of meat appears to be consumers\u2019 prime concern. There are other meats widely consumed in the Union, such as swine, sheep, goat and poultrymeat. It is therefore appropriate to impose a mandatory declaration of origin for those products. The specific origin requirements could differ from one type of meat to another according to the characteristics of the animal species. It is appropriate to provide for the establishment through implementing rules of mandatory requirements that could vary from one type of meat to another taking into account the principle of proportionality and the administrative burden for food business operators and enforcement authorities. (32) Mandatory origin provisions have been developed on the basis of vertical approaches for instance for honey (14), fruit and vegetables (15), fish (16), beef and beef products (17) and olive oil (18). There is a need to explore the possibility to extend mandatory origin labelling for other foods. It is therefore appropriate to request the Commission to prepare reports covering the following foods: types of meat other than beef, swine, sheep, goat and poultrymeat; milk; milk used as an ingredient in dairy products; meat used as an ingredient; unprocessed foods; single-ingredient products; and ingredients that represent more than 50 % of a food. Milk being one of the products for which an indication of origin is considered of particular interest, the Commission report on this product should be made available as soon as possible. Based on the conclusions of such reports, the Commission may submit proposals to modify the relevant Union provisions or may take new initiatives, where appropriate, on a sectoral basis. (33) The Union\u2019s non-preferential rules of origin are laid down in Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (19) and its implementing provisions in Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (20). Determination of the country of origin of foods will be based on those rules, which are well known to food business operators and administrations and should ease their implementation. (34) The nutrition declaration for a food concerns information on the presence of energy and certain nutrients in foods. The mandatory provision of nutrition information on packaging should assist nutrition actions as part of public health policies which could involve the provision of scientific recommendations for nutrition education for the public and support informed food choices. (35) To facilitate the comparison of products in different package sizes, it is appropriate to retain the requirement that the mandatory nutrition declaration should refer to 100 g or 100 ml amounts and, if appropriate, to allow additional portion-based declarations. Therefore, where food is prepacked and individual portions or consumption units are identified, a nutrition declaration per portion or per consumption unit, in addition to the expression per 100 g or per 100 ml, should be allowed. Furthermore, in order to provide comparable indications relating to portions or consumption units, the Commission should be empowered to adopt rules on the expression of the nutrition declaration per portion or per consumption unit for specific categories of food. (36) The Commission White Paper highlighted certain nutritional elements of importance to public health such as saturated fat, sugars or sodium. Therefore, it is appropriate that the requirements on the mandatory provision of nutrition information should take into account such elements. (37) Since one of the objectives pursued by this Regulation is to provide a basis to the final consumer for making informed choices, it is important to ensure in this respect that the final consumer easily understands the information provided on the labelling. Therefore it is appropriate to use on the labelling the term \u2018salt\u2019 instead of the corresponding term of the nutrient \u2018sodium\u2019. (38) In the interest of consistency and coherence of Union law the voluntary inclusion of nutrition or health claims on food labels should be in accordance with the Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (21). (39) To avoid unnecessary burdens on food business operators, it is appropriate to exempt from the mandatory provision of a nutrition declaration certain categories of foods that are unprocessed or for which nutrition information is not a determining factor for consumers\u2019 purchasing decisions, or for which the packaging is too small to accommodate the mandatory labelling requirements, unless the obligation to provide such information is provided for under other Union rules. (40) Taking into account the specific nature of alcoholic beverages, it is appropriate to invite the Commission to analyse further the information requirements for those products. Therefore, the Commission should, taking into account the need to ensure coherence with other relevant Union policies, produce a report within 3 years of the entry into force of this Regulation concerning the application of the requirements to provide information on ingredients and nutrition information to alcoholic beverages. In addition, taking into account the resolution of the European Parliament of 5 September 2007 on an European Union strategy to support Member States in reducing alcohol-related harm (22), the opinion of the European Economic and Social Committee (23), the work of the Commission, and general public concern about alcohol-related harm especially to young and vulnerable consumers, the Commission, after consultation with stakeholders and the Member States, should consider the need for a definition of beverages such as \u2018alcopops\u2019, which are specifically targeted at young people. The Commission should also, if appropriate, propose specific requirements relating to alcoholic beverages in the context of this Regulation. (41) To appeal to the average consumer and to serve the informative purpose for which it is introduced, and given the current level of knowledge on the subject of nutrition, the nutrition information provided should be simple and easily understood. To have the nutrition information partly in the principal field of vision, commonly known as the \u2018front of pack\u2019, and partly on another side on the pack, for instance the \u2018back of pack\u2019, might confuse consumers. Therefore, the nutrition declaration should be in the same field of vision. In addition, on a voluntary basis, the most important elements of the nutrition information may be repeated in the principal field of vision, in order to help consumers to easily see the essential nutrition information when purchasing foods. A free choice as to the information that could be repeated might confuse consumers. Therefore it is necessary to clarify which information may be repeated. (42) In order to encourage food business operators to provide on a voluntary basis the information contained in the nutrition declaration for foods such as alcoholic beverages and non-prepacked foods that may be exempted from the nutrition declaration, the possibility should be given to declare only limited elements of the nutrition declaration. It is nevertheless appropriate to clearly establish the information that may be provided on a voluntary basis in order to avoid misleading the consumer by the free choice of the food business operator. (43) There have been recent developments in the expression of the nutrition declaration, other than per 100 g, per 100 ml or per portion, or in its presentation, through the use of graphical forms or symbols, by some Member States and organisations in the food sector. Such additional forms of expression and presentation may help consumers to better understand the nutrition declaration. However, there is insufficient evidence across all the Union on how the average consumer understands and uses the alternative forms of expression or presentation of the information. Therefore, it is appropriate to allow for different forms of expression and presentation to be developed on the basis of criteria established in this Regulation and to invite the Commission to prepare a report regarding the use of those forms of expression and presentation, their effect on the internal market and the advisability of further harmonisation. (44) In order to assist the Commission in producing that report, Member States should provide the Commission with the relevant information on the use of additional forms of expression and presentation of the nutrition declaration on the market in their territory. In order to do so, Member States should be empowered to request food business operators placing on the market in their territory foods bearing additional forms of expression or presentation to notify national authorities of the use of such additional forms and of the relevant justifications regarding the fulfilment of the requirements set out in this Regulation. (45) It is desirable to ensure a certain level of consistency in the development of additional forms of expression and presentation of the nutrition declaration. It is therefore appropriate to promote the constant exchange and sharing of best practices and experience between Member States and with the Commission and to promote the participation of stakeholders in such exchanges. (46) The declaration in the same field of vision of the amounts of nutritional elements and comparative indicators in an easily recognisable form to enable an assessment of the nutritional properties of a food should be considered in its entirety as part of the nutrition declaration and should not be treated as a group of individual claims. (47) Experience shows that in many cases voluntary food information is provided to the detriment of the clarity of the mandatory food information. Therefore, criteria should be provided to help food business operators and enforcement authorities to strike a balance between the provision of mandatory and voluntary food information. (48) Member States should retain the right, depending on local practical conditions and circumstances, to lay down rules in respect of the provision of information concerning non-prepacked foods. Although in such cases the consumer demand for other information is limited, information on potential allergens is considered very important. Evidence suggests that most food allergy incidents can be traced back to non-prepacked food. Therefore information on potential allergens should always be provided to the consumer. (49) As regards the matters specifically harmonised by this Regulation, Member States should not be able to adopt national provisions unless authorised by Union law. This Regulation should not prevent Member States from adopting national measures concerning matters not specifically harmonised by this Regulation. However, such national measures should not prohibit, impede or restrict the free movement of goods that are in conformity with this Regulation. (50) Union consumers show an increasing interest in the implementation of the Union animal welfare rules at the time of slaughter, including whether the animal was stunned before slaughter. In this respect, a study on the opportunity to provide consumers with the relevant information on the stunning of animals should be considered in the context of a future Union strategy for the protection and welfare of animals. (51) Food information rules should be able to adapt to a rapidly changing social, economic and technological environment. (52) Member States should carry out official controls in order to enforce compliance with this Regulation in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (24). (53) References to Directive 90/496/EEC in Regulation (EC) No 1924/2006 and in Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (25) should be updated to take this Regulation into account. Regulations (EC) No 1924/2006 and (EC) No 1925/2006 should therefore be amended accordingly. (54) Irregular and frequent updating of food information requirements may impose considerable administrative burdens on food businesses, especially small and medium-sized enterprises. It is therefore appropriate to ensure that measures that may be adopted by the Commission in exercising the powers conferred by this Regulation apply on the same day in any calendar year following an appropriate transitional period. Derogations from this principle should be permitted in cases of urgency where the purpose of the measures concerned is the protection of human health. (55) In order to enable food business operators to adapt the labelling of their products to the new requirements introduced by this Regulation, it is important to provide for appropriate transitional periods for the application of this Regulation. (56) Given the substantial changes in the requirements related to nutrition labelling introduced by this Regulation, in particular changes in relation to the content of the nutrition declaration, it is appropriate to authorise food business operators to anticipate the application of this Regulation. (57) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (58) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of, inter alia, the availability of certain mandatory particulars by means other than on the package or on the label, the list of foods not required to bear a list of ingredients, the re-examination of the list of substances or products causing allergies or intolerances, or the list of nutrients that may be declared on a voluntary basis. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (59) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt implementing acts in relation to, inter alia, the modalities of expression of one or more particulars by means of pictograms or symbols instead of words or numbers, the manner of indicating the date of minimum durability, the manner of indicating the country of origin or place of provenance for meat, the precision of the declared values for the nutrition declaration, or the expression per portion or per consumption unit of the nutrition declaration. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (26), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation provides the basis for the assurance of a high level of consumer protection in relation to food information, taking into account the differences in the perception of consumers and their information needs whilst ensuring the smooth functioning of the internal market. 2. This Regulation establishes the general principles, requirements and responsibilities governing food information, and in particular food labelling. It lays down the means to guarantee the right of consumers to information and procedures for the provision of food information, taking into account the need to provide sufficient flexibility to respond to future developments and new information requirements. 3. This Regulation shall apply to food business operators at all stages of the food chain, where their activities concern the provision of food information to consumers. It shall apply to all foods intended for the final consumer, including foods delivered by mass caterers, and foods intended for supply to mass caterers. This Regulation shall apply to catering services provided by transport undertakings when the departure takes place on the territories of the Member States to which the Treaties apply. 4. This Regulation shall apply without prejudice to labelling requirements provided for in specific Union provisions applicable to particular foods. Article 2 Definitions 1. For the purposes of this Regulation, the following definitions shall apply: (a) the definitions of \u2018food\u2019, \u2018food law\u2019, \u2018food business\u2019, \u2018food business operator\u2019, \u2018retail\u2019, \u2018placing on the market\u2019 and \u2018final consumer\u2019 in Article 2 and in points (1), (2), (3), (7), (8) and (18) of Article 3 of Regulation (EC) No 178/2002; (b) the definitions of \u2018processing\u2019, \u2018unprocessed products\u2019 and \u2018processed products\u2019 in points (m), (n) and (o) of Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (27); (c) the definition of \u2018food enzyme\u2019 in point (a) of Article 3(2) of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (28); (d) the definitions of \u2018food additive\u2019, \u2018processing aid\u2019 and \u2018carrier\u2019 in points (a) and (b) of Article 3(2) of, and in point 5 of Annex I to, Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (29); (e) the definition of \u2018flavourings\u2019 in point (a) of Article 3(2) of Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (30); (f) the definitions of \u2018meat\u2019, \u2018mechanically separated meat\u2019, \u2018meat preparations\u2019, \u2018fishery products\u2019 and \u2018meat products\u2019 in points 1.1, 1.14, 1.15, 3.1 and 7.1 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (31); (g) the definition of \u2018advertising\u2019 in point (a) of Article 2 of Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (32). 2. The following definitions shall also apply: (a) \u2018food information\u2019 means information concerning a food and made available to the final consumer by means of a label, other accompanying material, or any other means including modern technology tools or verbal communication; (b) \u2018food information law\u2019 means the Union provisions governing the food information, and in particular labelling, including rules of a general nature applicable to all foods in particular circumstances or to certain categories of foods and rules which apply only to specific foods; (c) \u2018mandatory food information\u2019 means the particulars that are required to be provided to the final consumer by Union provisions; (d) \u2018mass caterer\u2019 means any establishment (including a vehicle or a fixed or mobile stall), such as restaurants, canteens, schools, hospitals and catering enterprises in which, in the course of a business, food is prepared to be ready for consumption by the final consumer; (e) \u2018prepacked food\u2019 means any single item for presentation as such to the final consumer and to mass caterers, consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, but in any event in such a way that the contents cannot be altered without opening or changing the packaging; \u2018prepacked food\u2019 does not cover foods packed on the sales premises at the consumer\u2019s request or prepacked for direct sale; (f) \u2018ingredient\u2019 means any substance or product, including flavourings, food additives and food enzymes, and any constituent of a compound ingredient, used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; residues shall not be considered as \u2018ingredients\u2019; (g) \u2018place of provenance\u2019 means any place where a food is indicated to come from, and that is not the \u2018country of origin\u2019 as determined in accordance with Articles 23 to 26 of Regulation (EEC) No 2913/92; the name, business name or address of the food business operator on the label shall not constitute an indication of the country of origin or place of provenance of food within the meaning of this Regulation; (h) \u2018compound ingredient\u2019 means an ingredient that is itself the product of more than one ingredient; (i) \u2018label\u2019 means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to the packaging or container of food; (j) \u2018labelling\u2019 means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food; (k) \u2018field of vision\u2019 means all the surfaces of a package that can be read from a single viewing point; (l) \u2018principal field of vision\u2019 means the field of vision of a package which is most likely to be seen at first glance by the consumer at the time of purchase and that enables the consumer to immediately identify a product in terms of its character or nature and, if applicable, its brand name. If a package has several identical principal fields of vision, the principal field of vision is the one chosen by the food business operator; (m) \u2018legibility\u2019 means the physical appearance of information, by means of which the information is visually accessible to the general population and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background; (n) \u2018legal name\u2019 means the name of a food prescribed in the Union provisions applicable to it or, in the absence of such Union provisions, the name provided for in the laws, regulations and administrative provisions applicable in the Member State in which the food is sold to the final consumer or to mass caterers; (o) \u2018customary name\u2019 means a name which is accepted as the name of the food by consumers in the Member State in which that food is sold, without that name needing further explanation; (p) \u2018descriptive name\u2019 means a name providing a description of the food, and if necessary of its use, which is sufficiently clear to enable consumers to know its true nature and distinguish it from other products with which it might be confused; (q) \u2018primary ingredient\u2019 means an ingredient or ingredients of a food that represent more than 50 % of that food or which are usually associated with the name of the food by the consumer and for which in most cases a quantitative indication is required; (r) \u2018date of minimum durability of a food\u2019 means the date until which the food retains its specific properties when properly stored; (s) \u2018nutrient\u2019 means protein, carbohydrate, fat, fibre, sodium, vitamins and minerals listed in point 1 of Part A of Annex XIII to this Regulation, and substances which belong to or are components of one of those categories; (t) \u2018engineered nanomaterial\u2019 means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material; (u) \u2018means of distance communication\u2019 means any means which, without the simultaneous physical presence of the supplier and the consumer, may be used for the conclusion of a contract between those parties. 3. For the purposes of this Regulation the country of origin of a food shall refer to the origin of a food as determined in accordance with Articles 23 to 26 of Regulation (EEC) No 2913/92. 4. The specific definitions set out in Annex I shall also apply. CHAPTER II GENERAL PRINCIPLES ON FOOD INFORMATION Article 3 General objectives 1. The provision of food information shall pursue a high level of protection of consumers\u2019 health and interests by providing a basis for final consumers to make informed choices and to make safe use of food, with particular regard to health, economic, environmental, social and ethical considerations. 2. Food information law shall aim to achieve in the Union the free movement of legally produced and marketed food, taking into account, where appropriate, the need to protect the legitimate interests of producers and to promote the production of quality products. 3. When food information law establishes new requirements, a transitional period after the entry into force of the new requirements shall be granted, except in duly justified cases. During such transitional period, foods bearing labels not complying with the new requirements may be placed on the market, and stocks of such foods that have been placed on the market before the end of the transitional period may continue to be sold until exhausted. 4. An open and transparent public consultation shall be conducted, including with stakeholders, directly or through representative bodies, during the preparation, evaluation and revision of food information law, except where the urgency of the matter does not allow it. Article 4 Principles governing mandatory food information 1. Where mandatory food information is required by food information law, it shall concern information that falls, in particular, into one of the following categories: (a) information on the identity and composition, properties or other characteristics of the food; (b) information on the protection of consumers\u2019 health and the safe use of a food. In particular, it shall concern information on: (i) compositional attributes that may be harmful to the health of certain groups of consumers; (ii) durability, storage and safe use; (iii) the health impact, including the risks and consequences related to harmful and hazardous consumption of a food; (c) information on nutritional characteristics so as to enable consumers, including those with special dietary requirements, to make informed choices. 2. When considering the need for mandatory food information and to enable consumers to make informed choices, account shall be taken of a widespread need on the part of the majority of consumers for certain information to which they attach significant value or of any generally accepted benefits to the consumer. Article 5 Consultation of the European Food Safety Authority Any Union measure in the field of food information law which is likely to have an effect on public health shall be adopted after consultation of the European Food Safety Authority (\u2018the Authority\u2019). CHAPTER III GENERAL FOOD INFORMATION REQUIREMENTS AND RESPONSIBILITIES OF FOOD BUSINESS OPERATORS Article 6 Basic requirement Any food intended for supply to the final consumer or to mass caterers shall be accompanied by food information in accordance with this Regulation. Article 7 Fair information practices 1. Food information shall not be misleading, particularly: (a) as to the characteristics of the food and, in particular, as to its nature, identity, properties, composition, quantity, durability, country of origin or place of provenance, method of manufacture or production; (b) by attributing to the food effects or properties which it does not possess; (c) by suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics, in particular by specifically emphasising the presence or absence of certain ingredients and/or nutrients; (d) by suggesting, by means of the appearance, the description or pictorial representations, the presence of a particular food or an ingredient, while in reality a component naturally present or an ingredient normally used in that food has been substituted with a different component or a different ingredient. 2. Food information shall be accurate, clear and easy to understand for the consumer. 3. Subject to derogations provided for by Union law applicable to natural mineral waters and foods for particular nutritional uses, food information shall not attribute to any food the property of preventing, treating or curing a human disease, nor refer to such properties. 4. Paragraphs 1, 2 and 3 shall also apply to: (a) advertising; (b) the presentation of foods, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed. Article 8 Responsibilities 1. The food business operator responsible for the food information shall be the operator under whose name or business name the food is marketed or, if that operator is not established in the Union, the importer into the Union market. 2. The food business operator responsible for the food information shall ensure the presence and accuracy of the food information in accordance with the applicable food information law and requirements of relevant national provisions. 3. Food business operators which do not affect food information shall not supply food which they know or presume, on the basis of the information in their possession as professionals, to be non-compliant with the applicable food information law and requirements of relevant national provisions. 4. Food business operators, within the businesses under their control, shall not modify the information accompanying a food if such modification would mislead the final consumer or otherwise reduce the level of consumer protection and the possibilities for the final consumer to make informed choices. Food business operators are responsible for any changes they make to food information accompanying a food. 5. Without prejudice to paragraphs 2 to 4, food business operators, within the businesses under their control, shall ensure compliance with the requirements of food information law and relevant national provisions which are relevant to their activities and shall verify that such requirements are met. 6. Food business operators, within the businesses under their control, shall ensure that information relating to non-prepacked food intended for the final consumer or for supply to mass caterers shall be transmitted to the food business operator receiving the food in order to enable, when required, the provision of mandatory food information to the final consumer. 7. In the following cases, food business operators, within the businesses under their control, shall ensure that the mandatory particulars required under Articles 9 and 10 shall appear on the prepackaging or on a label attached thereto, or on the commercial documents referring to the foods where it can be guaranteed that such documents either accompany the food to which they refer or were sent before or at the same time as delivery: (a) where prepacked food is intended for the final consumer but marketed at a stage prior to sale to the final consumer and where sale to a mass caterer is not involved at that stage; (b) where prepacked food is intended for supply to mass caterers for preparation, processing, splitting or cutting up. Notwithstanding the first subparagraph, food business operators shall ensure that the particulars referred to in points (a), (f), (g) and (h) of Article 9(1) also appear on the external packaging in which the prepacked foods are presented for marketing. 8. Food business operators that supply to other food business operators food not intended for the final consumer or to mass caterers shall ensure that those other food business operators are provided with sufficient information to enable them, where appropriate, to meet their obligations under paragraph 2. CHAPTER IV MANDATORY FOOD INFORMATION SECTION 1 Content and presentation Article 9 List of mandatory particulars 1. In accordance with Articles 10 to 35 and subject to the exceptions contained in this Chapter, indication of the following particulars shall be mandatory: (a) the name of the food; (b) the list of ingredients; (c) any ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II causing allergies or intolerances used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; (d) the quantity of certain ingredients or categories of ingredients; (e) the net quantity of the food; (f) the date of minimum durability or the \u2018use by\u2019 date; (g) any special storage conditions and/or conditions of use; (h) the name or business name and address of the food business operator referred to in Article 8(1); (i) the country of origin or place of provenance where provided for in Article 26; (j) instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions; (k) with respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume; (l) a nutrition declaration. 2. The particulars referred to in paragraph 1 shall be indicated with words and numbers. Without prejudice to Article 35, they may additionally be expressed by means of pictograms or symbols. 3. Where the Commission adopts delegated and implementing acts referred to in this Article, the particulars referred to in paragraph 1 may alternatively be expressed by means of pictograms or symbols instead of words or numbers. In order to ensure that consumers benefit from other means of expression of mandatory food information than words and numbers, and provided that the same level of information as with words and numbers is ensured, the Commission, taking into account evidence of uniform consumer understanding, may establish, by means of delegated acts in accordance with Article 51, the criteria subject to which one or more particulars referred to in paragraph 1 may be expressed by pictograms or symbols instead of words or numbers. 4. For the purpose of ensuring the uniform implementation of paragraph 3 of this Article, the Commission may adopt implementing acts on the modalities of application of the criteria defined in accordance with paragraph 3 to express one or more particulars by means of pictograms or symbols instead of words or numbers. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). Article 10 Additional mandatory particulars for specific types or categories of foods 1. In addition to the particulars listed in Article 9(1), additional mandatory particulars for specific types or categories of foods are laid down in Annex III. 2. In order to ensure consumer information with respect to specific types or categories of foods and to take account of technical progress, scientific developments, the protection of consumers\u2019 health or the safe use of a food, the Commission may amend Annex III by means of delegated acts, in accordance with Article 51. Where, in the case of the emergence of a risk to consumers\u2019 health, imperative grounds of urgency so require, the procedure provided for in Article 52 shall apply to delegated acts adopted pursuant to this Article. Article 11 Weights and measures Article 9 shall be without prejudice to more specific Union provisions regarding weights and measures. Article 12 Availability and placement of mandatory food information 1. Mandatory food information shall be available and shall be easily accessible, in accordance with this Regulation, for all foods. 2. In the case of prepacked food, mandatory food information shall appear directly on the package or on a label attached thereto. 3. In order to ensure that consumers benefit from other means of provision of mandatory food information better adapted for certain mandatory particulars, and provided that the same level of information as by means of the package or the label is ensured, the Commission, taking into account evidence of uniform consumer understanding and of the wide use of these means by consumers, may establish, by means of delegated acts in accordance with Article 51, criteria subject to which certain mandatory particulars may be expressed by means other than on the package or on the label. 4. For the purposes of ensuring the uniform implementation of paragraph 3 of this Article, the Commission may adopt implementing acts on the modalities of application of the criteria referred to in paragraph 3 in order to express certain mandatory particulars by means other than on the package or on the label. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). 5. In the case of non-prepacked food, the provisions of Article 44 shall apply. Article 13 Presentation of mandatory particulars 1. Without prejudice to the national measures adopted under Article 44(2), mandatory food information shall be marked in a conspicuous place in such a way as to be easily visible, clearly legible and, where appropriate, indelible. It shall not in any way be hidden, obscured, detracted from or interrupted by any other written or pictorial matter or any other intervening material. 2. Without prejudice to specific Union provisions applicable to particular foods, when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be printed on the package or on the label in such a way as to ensure clear legibility, in characters using a font size where the x-height, as defined in Annex IV, is equal to or greater than 1,2 mm. 3. In case of packaging or containers the largest surface of which has an area of less than 80 cm2, the x-height of the font size referred to in paragraph 2 shall be equal to or greater than 0,9 mm. 4. For the purpose of achieving the objectives of this Regulation, the Commission shall, by means of delegated acts in accordance with Article 51, establish rules for legibility. For the same purpose as referred to in the first subparagraph, the Commission may, by means of delegated acts in accordance with Article 51, extend the requirements under paragraph 5 of this Article to additional mandatory particulars for specific types or categories of foods. 5. The particulars listed in points (a), (e) and (k) of Article 9(1) shall appear in the same field of vision. 6. Paragraph 5 of this Article shall not apply in the cases specified in Article 16(1) and (2). Article 14 Distance selling 1. Without prejudice to the information requirements laid down in Article 9, in the case of prepacked foods offered for sale by means of distance communication: (a) mandatory food information, except the particulars provided in point (f) of Article 9(1), shall be available before the purchase is concluded and shall appear on the material supporting the distance selling or be provided through other appropriate means clearly identified by the food business operator. When other appropriate means are used, the mandatory food information shall be provided without the food business operator charging consumers supplementary costs; (b) all mandatory particulars shall be available at the moment of delivery. 2. In the case of non-prepacked foods offered for sale by means of distance communication, the particulars required under Article 44 shall be made available in accordance with paragraph 1 of this Article. 3. Point (a) of paragraph 1 shall not apply to foods offered for sale by means of automatic vending machines or automated commercial premises. Article 15 Language requirements 1. Without prejudice to Article 9(3), mandatory food information shall appear in a language easily understood by the consumers of the Member States where a food is marketed. 2. Within their own territory, the Member States in which a food is marketed may stipulate that the particulars shall be given in one or more languages from among the official languages of the Union. 3. Paragraphs 1 and 2 shall not preclude the particulars from being indicated in several languages. Article 16 Omission of certain mandatory particulars 1. In the case of glass bottles intended for reuse which are indelibly marked and which therefore bear no label, ring or collar only the particulars listed in points (a), (c), (e), (f) and (l) of Article 9(1) shall be mandatory. 2. In the case of packaging or containers the largest surface of which has an area of less than 10 cm2 only the particulars listed in points (a), (c), (e) and (f) of Article 9(1) shall be mandatory on the package or on the label. The particulars referred to in point (b) of Article 9(1) shall be provided through other means or shall be made available at the request of the consumer. 3. Without prejudice to other Union provisions requiring a mandatory nutrition declaration, the declaration referred to in point (l) of Article 9(1) shall not be mandatory for the foods listed in Annex V. 4. Without prejudice to other Union provisions requiring a list of ingredients or a mandatory nutrition declaration, the particulars referred to in points (b) and (l) of Article 9(1) shall not be mandatory for beverages containing more than 1,2 % by volume of alcohol. By 13 December 2014, the Commission shall produce a report concerning the application of Article 18 and Article 30(1) to the products referred to in this paragraph, and addressing whether alcoholic beverages should in future be covered, in particular, by the requirement to provide the information on the energy value, and the reasons justifying possible exemptions, taking into account the need to ensure coherence with other relevant Union policies. In this context, the Commission shall consider the need to propose a definition of \u2018alcopops\u2019. The Commission shall accompany that report by a legislative proposal, if appropriate, determining the rules for a list of ingredients or a mandatory nutrition declaration for those products. SECTION 2 Detailed provisions on mandatory particulars Article 17 Name of the food 1. The name of the food shall be its legal name. In the absence of such a name, the name of the food shall be its customary name, or, if there is no customary name or the customary name is not used, a descriptive name of the food shall be provided. 2. The use in the Member State of marketing of the name of the food under which the product is legally manufactured and marketed in the Member State of production shall be allowed. However, where the application of the other provisions of this Regulation, in particular those set out in Article 9, would not enable consumers in the Member State of marketing to know the true nature of the food and to distinguish it from foods with which they could confuse it, the name of the food shall be accompanied by other descriptive information which shall appear in proximity to the name of the food. 3. In exceptional cases, the name of the food in the Member State of production shall not be used in the Member State of marketing when the food which it designates in the Member State of production is so different, as regards its composition or manufacture, from the food known under that name in the Member State of marketing that paragraph 2 is not sufficient to ensure, in the Member State of marketing, correct information for consumers. 4. The name of the food shall not be replaced with a name protected as intellectual property, brand name or fancy name. 5. Specific provisions on the name of the food and particulars that shall accompany it are laid down in Annex VI. Article 18 List of ingredients 1. The list of ingredients shall be headed or preceded by a suitable heading which consists of or includes the word \u2018ingredients\u2019. It shall include all the ingredients of the food, in descending order of weight, as recorded at the time of their use in the manufacture of the food. 2. Ingredients shall be designated by their specific name, where applicable, in accordance with the rules laid down in Article 17 and in Annex VI. 3. All ingredients present in the form of engineered nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word \u2018nano\u2019 in brackets. 4. Technical rules for applying paragraphs 1 and 2 of this Article are laid down in Annex VII. 5. For the purposes of achieving the objectives of this Regulation, the Commission shall, by means of delegated acts in accordance with Article 51, adjust and adapt the definition of engineered nanomaterials referred to in point (t) of Article 2(2) to technical and scientific progress or to definitions agreed at international level. Article 19 Omission of the list of ingredients 1. The following foods shall not be required to bear a list of ingredients: (a) fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated; (b) carbonated water, the description of which indicates that it has been carbonated; (c) fermentation vinegars derived exclusively from a single basic product, provided that no other ingredient has been added; (d) cheese, butter, fermented milk and cream, to which no ingredient has been added other than lactic products, food enzymes and micro-organism cultures essential to manufacture, or in the case of cheese other than fresh cheese and processed cheese the salt needed for its manufacture; (e) foods consisting of a single ingredient, where: (i) the name of the food is identical to the ingredient name; or (ii) the name of the food enables the nature of the ingredient to be clearly identified. 2. In order to take into account the relevance for the consumer of a list of ingredients for specific types or categories of foods, the Commission may, in exceptional cases, by means of delegated acts, in accordance with Article 51, supplement paragraph 1 of this Article, provided that omissions do not result in the final consumer or mass caterers being inadequately informed. Article 20 Omission of constituents of food from the list of ingredients Without prejudice to Article 21, the following constituents of a food shall not be required to be included in the list of ingredients: (a) the constituents of an ingredient which have been temporarily separated during the manufacturing process and later reintroduced but not in excess of their original proportions; (b) food additives and food enzymes: (i) whose presence in a given food is solely due to the fact that they were contained in one or more ingredients of that food, in accordance with the carry-over principle referred to in points (a) and (b) of Article 18(1) of Regulation (EC) No 1333/2008, provided that they serve no technological function in the finished product; or (ii) which are used as processing aids; (c) carriers and substances which are not food additives but are used in the same way and with the same purpose as carriers, and which are used in the quantities strictly necessary; (d) substances which are not food additives but are used in the same way and with the same purpose as processing aids and are still present in the finished product, even if in an altered form; (e) water: (i) where the water is used during the manufacturing process solely for the reconstitution of an ingredient used in concentrated or dehydrated form; or (ii) in the case of a liquid medium which is not normally consumed. Article 21 Labelling of certain substances or products causing allergies or intolerances 1. Without prejudice to the rules adopted under Article 44(2), the particulars referred to in point (c) of Article 9(1) shall meet the following requirements: (a) they shall be indicated in the list of ingredients in accordance with the rules laid down in Article 18(1), with a clear reference to the name of the substance or product as listed in Annex II; and (b) the name of the substance or product as listed in Annex II shall be emphasised through a typeset that clearly distinguishes it from the rest of the list of ingredients, for example by means of the font, style or background colour. In the absence of a list of ingredients, the indication of the particulars referred to in point (c) of Article 9(1) shall comprise the word \u2018contains\u2019 followed by the name of the substance or product as listed in Annex II. Where several ingredients or processing aids of a food originate from a single substance or product listed in Annex II, the labelling shall make it clear for each ingredient or processing aid concerned. The indication of the particulars referred to in point (c) of Article 9(1) shall not be required in cases where the name of the food clearly refers to the substance or product concerned. 2. In order to ensure better information for consumers and to take account of the most recent scientific progress and technical knowledge, the Commission shall systematically re-examine and, where necessary, update the list in Annex II by means of delegated acts, in accordance with Article 51. Where, in the case of the emergence of a risk to consumers\u2019 health, imperative grounds of urgency so require, the procedure provided for in Article 52 shall apply to delegated acts adopted pursuant to this Article. Article 22 Quantitative indication of ingredients 1. The indication of the quantity of an ingredient or category of ingredients used in the manufacture or preparation of a food shall be required where the ingredient or category of ingredients concerned: (a) appears in the name of the food or is usually associated with that name by the consumer; (b) is emphasised on the labelling in words, pictures or graphics; or (c) is essential to characterise a food and to distinguish it from products with which it might be confused because of its name or appearance. 2. Technical rules for applying paragraph 1, including specific cases where the quantitative indication shall not be required in respect of certain ingredients, are laid down in Annex VIII. Article 23 Net quantity 1. The net quantity of a food shall be expressed using litres, centilitres, millilitres, kilograms or grams, as appropriate: (a) in units of volume in the case of liquid products; (b) in units of mass in the case of other products. 2. In order to ensure a better understanding by the consumer of the food information on the labelling, the Commission may establish for certain specified foods, by means of delegated acts, in accordance with Article 51, a manner for the expression of the net quantity other than the one laid down in paragraph 1 of this Article. 3. Technical rules for applying paragraph 1, including specific cases where the indication of the net quantity shall not be required, are laid down in Annex IX. Article 24 Minimum durability date, \u2018use by\u2019 date and date of freezing 1. In the case of foods which, from a microbiological point of view, are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health, the date of minimum durability shall be replaced by the \u2018use by\u2019 date. After the \u2018use by\u2019 date a food shall be deemed to be unsafe in accordance with Article 14(2) to (5) of Regulation (EC) No 178/2002. 2. The appropriate date shall be expressed in accordance with Annex X. 3. In order to ensure a uniform application of the manner of indicating the date of minimum durability referred to in point 1(c) of Annex X, the Commission may adopt implementing acts setting out rules in this regard. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). Article 25 Storage conditions or conditions of use 1. In cases where foods require special storage conditions and/or conditions of use, those conditions shall be indicated. 2. To enable appropriate storage or use of the food after opening the package, the storage conditions and/or time limit for consumption shall be indicated, where appropriate. Article 26 Country of origin or place of provenance 1. This Article shall apply without prejudice to labelling requirements provided for in specific Union provisions, in particular Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialties guaranteed (33) and Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (34). 2. Indication of the country of origin or place of provenance shall be mandatory: (a) where failure to indicate this might mislead the consumer as to the true country of origin or place of provenance of the food, in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance; (b) for meat falling within the Combined Nomenclature (\u2018CN\u2019) codes listed in Annex XI. The application of this point shall be subject to the adoption of implementing acts referred to in paragraph 8. 3. Where the country of origin or the place of provenance of a food is given and where it is not the same as that of its primary ingredient: (a) the country of origin or place of provenance of the primary ingredient in question shall also be given; or (b) the country of origin or place of provenance of the primary ingredient shall be indicated as being different to that of the food. The application of this paragraph shall be subject to the adoption of the implementing acts referred to in paragraph 8. 4. Within 5 years from the date of application of point (b) of paragraph 2, the Commission shall submit a report to the European Parliament and the Council to evaluate the mandatory indication of the country of origin or place of provenance for products referred to in that point. 5. By 13 December 2014, the Commission shall submit reports to the European Parliament and the Council regarding the mandatory indication of the country of origin or place of provenance for the following foods: (a) types of meat other than beef and those referred to in point (b) of paragraph 2; (b) milk; (c) milk used as an ingredient in dairy products; (d) unprocessed foods; (e) single ingredient products; (f) ingredients that represent more than 50 % of a food. 6. By 13 December 2013, the Commission shall submit a report to the European Parliament and the Council regarding the mandatory indication of the country of origin or place of provenance for meat used as an ingredient. 7. The reports referred to in paragraphs 5 and 6 shall take into account the need for the consumer to be informed, the feasibility of providing the mandatory indication of the country of origin or place of provenance and an analysis of the costs and benefits of the introduction of such measures, including the legal impact on the internal market and the impact on international trade. The Commission may accompany those reports with proposals to modify the relevant Union provisions. 8. By 13 December 2013, following impact assessments, the Commission shall adopt implementing acts concerning the application of point (b) of paragraph 2 of this Article and the application of paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). 9. In the case of foods referred to in point (b) of paragraph 2, in point (a) of paragraph 5 and in paragraph 6, the reports and the impact assessments under this Article shall consider, inter alia, the options for the modalities of expressing the country of origin or place of provenance of those foods, in particular with respect to each of the following determining points in the life of the animal: (a) place of birth; (b) place of rearing; (c) place of slaughter. Article 27 Instructions for use 1. The instructions for use of a food shall be indicated in such a way as to enable appropriate use to be made of the food. 2. The Commission may adopt implementing acts setting out detailed rules concerning the implementation of paragraph 1 for certain foods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). Article 28 Alcoholic strength 1. The rules concerning indication of the alcoholic strength by volume shall, in the case of products classified in CN code 2204, be those laid down in the specific Union provisions applicable to such products. 2. The actual alcoholic strength by volume of beverages containing more than 1,2 % by volume of alcohol other than those referred to in paragraph 1 shall be indicated in accordance with Annex XII. SECTION 3 Nutrition declaration Article 29 Relationship with other legislation 1. This Section shall not apply to foods falling within the scope of the following legislation: (a) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (35); (b) Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (36). 2. This Section shall apply without prejudice to Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (37) and specific Directives as referred to in Article 4(1) of that Directive. Article 30 Content 1. The mandatory nutrition declaration shall include the following: (a) energy value; and (b) the amounts of fat, saturates, carbohydrate, sugars, protein and salt. Where appropriate, a statement indicating that the salt content is exclusively due to the presence of naturally occurring sodium may appear in close proximity to the nutrition declaration. 2. The content of the mandatory nutrition declaration referred to in paragraph 1 may be supplemented with an indication of the amounts of one or more of the following: (a) mono-unsaturates; (b) polyunsaturates; (c) polyols; (d) starch; (e) fibre; (f) any of the vitamins or minerals listed in point 1 of Part A of Annex XIII, and present in significant amounts as defined in point 2 of Part A of Annex XIII. 3. Where the labelling of a prepacked food provides the mandatory nutrition declaration referred to in paragraph 1, the following information may be repeated thereon: (a) the energy value; or (b) the energy value together with the amounts of fat, saturates, sugars, and salt. 4. By way of derogation from Article 36(1), where the labelling of the products referred to in Article 16(4) provides a nutrition declaration, the content of the declaration may be limited to the energy value only. 5. Without prejudice to Article 44 and by way of derogation from Article 36(1), where the labelling of the products referred to in Article 44(1) provides a nutrition declaration, the content of that declaration may be limited only to: (a) the energy value; or (b) the energy value together with the amounts of fat, saturates, sugars, and salt. 6. In order to take account of the relevance of particulars referred to in paragraphs 2 to 5 of this Article for the information of consumers, the Commission may, by means of delegated acts, in accordance with Article 51, amend the lists in paragraphs 2 to 5 of this Article, by adding or removing particulars. 7. By 13 December 2014, the Commission, taking into account scientific evidence and experience acquired in Member States, shall submit a report on the presence of trans fats in foods and in the overall diet of the Union population. The aim of the report shall be to assess the impact of appropriate means that could enable consumers to make healthier food and overall dietary choices or that could promote the provision of healthier food options to consumers, including, among others, the provision of information on trans fats to consumers or restrictions on their use. The Commission shall accompany this report with a legislative proposal, if appropriate. Article 31 Calculation 1. The energy value shall be calculated using the conversion factors listed in Annex XIV. 2. The Commission may adopt, by means of delegated acts, in accordance with Article 51, conversion factors for the vitamins and minerals referred to in point 1 of Part A of Annex XIII, in order to calculate more precisely the content of such vitamins and minerals in foods. Those conversion factors shall be added to Annex XIV. 3. The energy value and the amounts of nutrients referred to in Article 30(1) to (5) shall be those of the food as sold. Where appropriate, the information may relate to the food after preparation, provided that sufficiently detailed preparation instructions are given and the information relates to the food as prepared for consumption. 4. The declared values shall, according to the individual case, be average values based on: (a) the manufacturer\u2019s analysis of the food; (b) a calculation from the known or actual average values of the ingredients used; or (c) a calculation from generally established and accepted data. The Commission may adopt implementing acts setting out detailed rules for the uniform implementation of this paragraph with regard to the precision of the declared values such as the differences between the declared values and those established in the course of official checks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). Article 32 Expression per 100 g or per 100 ml 1. The energy value and the amount of nutrients referred to in Article 30(1) to (5) shall be expressed using the measurement units listed in Annex XV. 2. The energy value and the amount of nutrients referred to in Article 30(1) to (5) shall be expressed per 100 g or per 100 ml. 3. When provided, the declaration on vitamins and minerals shall, in addition to the form of expression referred to in paragraph 2, be expressed as a percentage of the reference intakes set out in point 1 of Part A of Annex XIII in relation to per 100 g or per 100 ml. 4. In addition to the form of expression referred to in paragraph 2 of this Article, the energy value and the amounts of nutrients referred to in Article 30(1), (3), (4) and (5) may be expressed, as appropriate, as a percentage of the reference intakes set out in Part B of Annex XIII in relation to per 100 g or per 100 ml. 5. Where information is provided pursuant to paragraph 4, the following additional statement shall be indicated in close proximity to it: \u2018Reference intake of an average adult (8 400 kJ/2 000 kcal)\u2019. Article 33 Expression on a per portion basis or per consumption unit 1. In the following cases, the energy value and the amounts of nutrients referred to in Article 30(1) to (5) may be expressed per portion and/or per consumption unit, easily recognisable by the consumer, provided that the portion or the unit used is quantified on the label and that the number of portions or units contained in the package is stated: (a) in addition to the form of expression per 100 g or per 100 ml referred to in Article 32(2); (b) in addition to the form of expression per 100 g or per 100 ml referred to in Article 32(3) regarding the amounts of vitamins and minerals; (c) in addition to or instead of the form of expression per 100 g or per 100 ml referred to in Article 32(4). 2. By way of derogation from Article 32(2), in the cases referred to in point (b) of Article 30(3) the amount of nutrients and/or the percentage of the reference intakes set out in Part B of Annex XIII may be expressed on the basis of per portion or per consumption unit alone. When the amounts of nutrients are expressed on the basis of per portion or per consumption unit alone in accordance with the first subparagraph, the energy value shall be expressed per 100 g or per 100 ml and on the basis of per portion or per consumption unit. 3. By way of derogation from Article 32(2), in the cases referred to in Article 30(5) the energy value and the amount of nutrients and/or the percentage of the reference intakes set out in Part B of Annex XIII may be expressed on the basis of per portion or per consumption unit alone. 4. The portion or unit used shall be indicated in close proximity to the nutrition declaration. 5. In order to ensure the uniform implementation of the expression of the nutrition declaration per portion or per unit of consumption and to provide for a uniform basis of comparison for the consumer, the Commission shall, taking into account actual consumption behaviour of consumers as well as dietary recommendations, adopt, by means of implementing acts, rules on the expression per portion or per consumption unit for specific categories of foods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). Article 34 Presentation 1. The particulars referred to in Article 30(1) and (2) shall be included in the same field of vision. They shall be presented together in a clear format and, where appropriate, in the order of presentation provided for in Annex XV. 2. The particulars referred to in Article 30(1) and (2) shall be presented, if space permits, in tabular format with the numbers aligned. Where space does not permit, the declaration shall appear in linear format. 3. The particulars referred to in Article 30(3) shall be presented: (a) in the principal field of vision; and (b) using a font size in accordance with Article 13(2). The particulars referred to in Article 30(3) may be presented in a format different from that specified in paragraph 2 of this Article. 4. The particulars referred to in Article 30(4) and (5) may be presented in a format different from that specified in paragraph 2 of this Article. 5. In cases where the energy value or the amount of nutrient(s) in a product is negligible, the information on those elements may be replaced by a statement such as \u2018Contains negligible amounts of \u2026\u2019 and shall be indicated in close proximity to the nutrition declaration when present. In order to ensure the uniform implementation of this paragraph, the Commission may adopt implementing acts regarding the energy value and amounts of nutrients referred to in Article 30(1) to (5) which can be regarded as negligible. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). 6. In order to ensure a uniform application of the manner of presenting the nutrition declaration under the formats referred to in paragraphs 1 to 4 of this Article, the Commission may adopt implementing acts in this regard. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). Article 35 Additional forms of expression and presentation 1. In addition to the forms of expression referred to in Article 32(2) and (4) and Article 33 and to the presentation referred to in Article 34(2), the energy value and the amount of nutrients referred to in Article 30(1) to (5) may be given by other forms of expression and/or presented using graphical forms or symbols in addition to words or numbers provided that the following requirements are met: (a) they are based on sound and scientifically valid consumer research and do not mislead the consumer as referred to in Article 7; (b) their development is the result of consultation with a wide range of stakeholder groups; (c) they aim to facilitate consumer understanding of the contribution or importance of the food to the energy and nutrient content of a diet; (d) they are supported by scientifically valid evidence of understanding of such forms of expression or presentation by the average consumer; (e) in the case of other forms of expression, they are based either on the harmonised reference intakes set out in Annex XIII, or in their absence, on generally accepted scientific advice on intakes for energy or nutrients; (f) they are objective and non-discriminatory; and (g) their application does not create obstacles to the free movement of goods. 2. Member States may recommend to food business operators the use of one or more additional forms of expression or presentation of the nutrition declaration that they consider as best fulfilling the requirements laid down in points (a) to (g) of paragraph 1. Member States shall provide the Commission with the details of such additional forms of expression and presentation. 3. Member States shall ensure an appropriate monitoring of additional forms of expression or presentation of the nutrition declaration that are present on the market in their territory. To facilitate the monitoring of the use of such additional forms of expression or presentation, Member States may require food business operators placing on the market in their territory foods bearing such information to notify the competent authority of the use of an additional form of expression or presentation and to provide them with the relevant justifications regarding the fulfilment of the requirements laid down in points (a) to (g) of paragraph 1. In such cases, information on the discontinuation of the use of such additional forms of expression or presentation may also be required. 4. The Commission shall facilitate and organise the exchange of information between Member States, itself and stakeholders on matters relating to the use of any additional forms of expression or presentation of the nutrition declaration. 5. By 13 December 2017, in the light of the experience gained, the Commission shall submit a report to the European Parliament and the Council on the use of additional forms of expression and presentation, on their effect on the internal market and on the advisability of further harmonisation of those forms of expression and presentation. For this purpose, Member States shall provide the Commission with relevant information concerning the use of such additional forms of expression or presentation on the market in their territory. The Commission may accompany this report with proposals to modify the relevant Union provisions. 6. In order to ensure the uniform application of this Article, the Commission shall adopt implementing acts setting out detailed rules concerning the implementation of paragraphs 1, 3 and 4 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). CHAPTER V VOLUNTARY FOOD INFORMATION Article 36 Applicable requirements 1. Where food information referred to in Articles 9 and 10 is provided on a voluntary basis, such information shall comply with the requirements laid down in Sections 2 and 3 of Chapter IV. 2. Food information provided on a voluntary basis shall meet the following requirements: (a) it shall not mislead the consumer, as referred to in Article 7; (b) it shall not be ambiguous or confusing for the consumer; and (c) it shall, where appropriate, be based on the relevant scientific data. 3. The Commission shall adopt implementing acts on the application of the requirements referred to in paragraph 2 of this Article to the following voluntary food information: (a) information on the possible and unintentional presence in food of substances or products causing allergies or intolerances; (b) information related to suitability of a food for vegetarians or vegans; and (c) the indication of reference intakes for specific population groups in addition to the reference intakes set out in Annex XIII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). 4. In order to ensure that consumers are appropriately informed, where voluntary food information is provided by food business operators on a divergent basis which might mislead or confuse the consumer, the Commission may, by means of delegated acts, in accordance with Article 51, provide for additional cases of provision of voluntary food information to the ones referred to in paragraph 3 of this Article. Article 37 Presentation Voluntary food information shall not be displayed to the detriment of the space available for mandatory food information. CHAPTER VI NATIONAL MEASURES Article 38 National measures 1. As regards the matters specifically harmonised by this Regulation, Member States may not adopt nor maintain national measures unless authorised by Union law. Those national measures shall not give rise to obstacles to free movement of goods, including discrimination as regards foods from other Member States. 2. Without prejudice to Article 39, Member States may adopt national measures concerning matters not specifically harmonised by this Regulation provided that they do not prohibit, impede or restrict the free movement of goods that are in conformity with this Regulation. Article 39 National measures on additional mandatory particulars 1. In addition to the mandatory particulars referred to in Article 9(1) and in Article 10, Member States may, in accordance with the procedure laid down in Article 45, adopt measures requiring additional mandatory particulars for specific types or categories of foods, justified on grounds of at least one of the following: (a) the protection of public health; (b) the protection of consumers; (c) the prevention of fraud; (d) the protection of industrial and commercial property rights, indications of provenance, registered designations of origin and the prevention of unfair competition. 2. By means of paragraph 1, Member States may introduce measures concerning the mandatory indication of the country of origin or place of provenance of foods only where there is a proven link between certain qualities of the food and its origin or provenance. When notifying such measures to the Commission, Member States shall provide evidence that the majority of consumers attach significant value to the provision of that information. Article 40 Milk and milk products Member States may adopt measures derogating from Article 9(1) and Article 10(1) in the case of milk and milk products presented in glass bottles intended for reuse. They shall communicate to the Commission the text of those measures without delay. Article 41 Alcoholic beverages Member States may, pending the adoption of the Union provisions referred to in Article 16(4), maintain national measures as regards the listing of ingredients in the case of beverages containing more than 1,2 % by volume of alcohol. Article 42 Expression of the net quantity In the absence of Union provisions referred to in Article 23(2) concerning the expression of net quantity for specified foods in a different manner to that provided for in Article 23(1), Member States may maintain national measures adopted before 12 December 2011. By 13 December 2014, Member States shall inform the Commission about such measures. The Commission shall bring them to the attention of the other Member States. Article 43 Voluntary indication of reference intakes for specific population groups Pending the adoption of the Union provisions referred to in point (c) of Article 36(3), Member States may adopt national measures on the voluntary indication of reference intakes for specific population groups. Member States shall communicate to the Commission the text of those measures without delay. Article 44 National measures for non-prepacked food 1. Where foods are offered for sale to the final consumer or to mass caterers without prepackaging, or where foods are packed on the sales premises at the consumer\u2019s request or prepacked for direct sale: (a) the provision of the particulars specified in point (c) of Article 9(1) is mandatory; (b) the provision of other particulars referred to in Articles 9 and 10 is not mandatory unless Member States adopt national measures requiring the provision of some or all of those particulars or elements of those particulars. 2. Member States may adopt national measures concerning the means through which the particulars or elements of those particulars specified in paragraph 1 are to be made available and, where appropriate, their form of expression and presentation. 3. Member States shall communicate to the Commission the text of the measures referred to in point (b) of paragraph 1 and in paragraph 2 without delay. Article 45 Notification procedure 1. When reference is made to this Article, the Member State which deems it necessary to adopt new food information legislation shall notify in advance the Commission and the other Member States of the measures envisaged and give the reasons justifying them. 2. The Commission shall consult the Standing Committee on the Food Chain and Animal Health set up by Article 58(1) of Regulation (EC) No 178/2002 if it considers such consultation to be useful or if a Member State so requests. In that case, the Commission shall ensure that this process is transparent for all stakeholders. 3. The Member State which deems it necessary to adopt new food information legislation may take the envisaged measures only 3 months after the notification referred to in paragraph 1, provided that it has not received a negative opinion from the Commission. 4. If the Commission\u2019s opinion is negative, and before the expiry of the period referred to in paragraph 3 of this Article, the Commission shall initiate the examination procedure referred to in Article 48(2) in order to determine whether the envisaged measures may be implemented subject, if necessary, to the appropriate modifications. 5. Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (38) shall not apply to the measures falling within the notification procedure specified in this Article. CHAPTER VII IMPLEMENTING, AMENDING AND FINAL PROVISIONS Article 46 Amendments to the Annexes In order to take into account technical progress, scientific developments, consumers\u2019 health, or consumers\u2019 need for information, and subject to the provisions of Article 10(2) and Article 21(2) relating to the amendments to Annexes II and III, the Commission may, by means of delegated acts in accordance with Article 51, amend the Annexes to this Regulation. Article 47 Transitional period for and date of application of implementing measures or delegated acts 1. Without prejudice to paragraph 2 of this Article, in exercising the powers conferred by this Regulation to adopt measures by means of implementing acts in accordance with the examination procedure referred to in Article 48(2) or by means of delegated acts in accordance with Article 51 the Commission shall: (a) establish an appropriate transitional period for application of the new measures, during which foods bearing labels not complying with the new measures may be placed on the market and after which stocks of such foods that have been placed on the market before the end of the transitional period may continue to be sold until exhausted; and (b) ensure that those measures apply as from 1 April in any calendar year. 2. Paragraph 1 shall not apply in cases of urgency where the purpose of the measures referred to in that paragraph is the protection of human health. Article 48 Committee 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58(1) of Regulation (EC) No 178/2002. That Committee is a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 49 Amendments to Regulation (EC) No 1924/2006 The first and second paragraphs of Article 7 of Regulation (EC) No 1924/2006 are replaced by the following: \u2018Nutrition labelling of products on which a nutrition and/or health claim is made shall be mandatory, with the exception of generic advertising. The information to be provided shall consist of that specified in Article 30(1) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (*1). Where a nutrition and/or health claim is made for a nutrient referred to in Article 30(2) of Regulation (EU) No 1169/2011 the amount of that nutrient shall be declared in accordance with Articles 31 to 34 of that Regulation. The amount(s) of the substance(s) to which a nutrition or health claim relates that does not appear in the nutrition labelling shall be stated in the same field of vision as the nutrition labelling and be expressed in accordance with Articles 31, 32 and 33 of Regulation (EU) No 1169/2011. The units of measurement used to express the amount of the substance shall be appropriate for the individual substances concerned. Article 50 Amendments to Regulation (EC) No 1925/2006 Paragraph 3 of Article 7 of Regulation (EC) No 1925/2006 is replaced by the following: \u20183. Nutrition labelling of products to which vitamins and minerals have been added and which are covered by this Regulation shall be compulsory. The information to be provided shall consist of that specified in Article 30(1) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (*2) and of the total amounts present of the vitamins and minerals when added to the food. Article 51 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 9(3), Article 10(2), Article 12(3), Article 13(4), Article 18(5), Article 19(2), Article 21(2), Article 23(2), Article 30(6), Article 31(2), Article 36(4) and Article 46 shall be conferred on the Commission for a period of 5 years after 12 December 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 9(3), Article 10(2), Article 12(3), Article 13(4), Article 18(5), Article 19(2), Article 21(2), Article 23(2), Article 30(6), Article 31(2), Article 36(4) and Article 46 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 9(3), Article 10(2), Article 12(3), Article 13(4), Article 18(5), Article 19(2), Article 21(2), Article 23(2), Article 30(6), Article 31(2), Article 36(4) and Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 52 Urgency procedure 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 51(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council. Article 53 Repeal 1. Directives 87/250/EEC, 90/496/EEC, 1999/10/EC, 2000/13/EC, 2002/67/EC and 2008/5/EC and Regulation (EC) No 608/2004 are repealed as from 13 December 2014. 2. References to the repealed acts shall be construed as references to this Regulation. Article 54 Transitional measures 1. Foods placed on the market or labelled prior to 13 December 2014 which do not comply with the requirements of this Regulation may be marketed until the stocks of the foods are exhausted. Foods placed on the market or labelled prior to 13 December 2016 which do not comply with the requirement laid down in point (l) of Article 9(1) may be marketed until the stocks of the foods are exhausted. Foods placed on the market or labelled prior to 1 January 2014 which do not comply with the requirements laid down in Part B of Annex VI may be marketed until the stocks of the foods are exhausted. 2. Between 13 December 2014 and 13 December 2016, where the nutrition declaration is provided on a voluntary basis, it shall comply with Articles 30 to 35. 3. Notwithstanding Directive 90/496/EEC, Article 7 of Regulation (EC) No 1924/2006 and Article 7(3) of Regulation (EC) No 1925/2006, foods labelled in accordance with Articles 30 to 35 of this Regulation may be placed on the market before 13 December 2014. Notwithstanding Commission Regulation (EC) No 1162/2009 of 30 November 2009 laying down transitional measures for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council (39), foods labelled in accordance with Part B of Annex VI to this Regulation may be placed on the market before 1 January 2014. Article 55 Entry into force and date of application This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 13 December 2014, with the exception of point (l) of Article 9(1), which shall apply from 13 December 2016, and Part B of Annex VI, which shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 October 2011. For the European Parliament The President J. BUZEK For the Council The President M. DOWGIELEWICZ (1) OJ C 77, 31.3.2009, p. 81. (2) Position of the European Parliament of 16 June 2010 (OJ C 236 E, 12.8.2011, p. 187) and position of the Council at first reading of 21 February 2011 (OJ C 102 E, 2.4.2011, p. 1). Position of the European Parliament of 6 July 2011 (not yet published in the Official Journal) and decision of the Council of 29 September 2011. (3) OJ L 31, 1.2.2002, p. 1. (4) OJ L 149, 11.6.2005, p. 22. (5) OJ L 109, 6.5.2000, p. 29. (6) OJ L 276, 6.10.1990, p. 40. (7) OJ L 113, 30.4.1987, p. 57. (8) OJ L 69, 16.3.1999, p. 22. (9) OJ L 191, 19.7.2002, p. 20. (10) OJ L 97, 1.4.2004, p. 44. (11) OJ L 27, 31.1.2008, p. 12. (12) OJ L 43, 14.2.1997, p. 1. (13) Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products (OJ L 204, 11.8.2000, p. 1). (14) Council Directive 2001/110/EC of 20 December 2001 relating to honey (OJ L 10, 12.1.2002, p. 47). (15) Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules of Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (OJ L 350, 31.12.2007, p. 1). (16) Council Regulation (EC) No 104/2000 of 17 December 1999 on the common organisation of the markets in fishery and aquaculture products (OJ L 17, 21.1.2000, p. 22). (17) Regulation (EC) No 1760/2000. (18) Commission Regulation (EC) No 1019/2002 of 13 June 2002 on marketing standards for olive oil (OJ L 155, 14.6.2002, p. 27). (19) OJ L 302, 19.10.1992, p. 1. (20) OJ L 253, 11.10.1993, p. 1. (21) OJ L 404, 30.12.2006, p. 9. (22) OJ C 187 E, 24.7.2008, p. 160. (23) OJ C 77, 31.3.2009, p. 81. (24) OJ L 165, 30.4.2004, p. 1. (25) OJ L 404, 30.12.2006, p. 26. (26) OJ L 55, 28.2.2011, p. 13. (27) OJ L 139, 30.4.2004, p. 1. (28) OJ L 354, 31.12.2008, p. 7. (29) OJ L 354, 31.12.2008, p. 16. (30) OJ L 354, 31.12.2008, p. 34. (31) OJ L 139, 30.4.2004, p. 55. (32) OJ L 376, 27.12.2006, p. 21. (33) OJ L 93, 31.3.2006, p. 1. (34) OJ L 93, 31.3.2006, p. 12. (35) OJ L 183, 12.7.2002, p. 51. (36) OJ L 164, 26.6.2009, p. 45. (37) OJ L 124, 20.5.2009, p. 21. (38) OJ L 204, 21.7.1998, p. 37. (39) OJ L 314, 1.12.2009, p. 10. ANNEX I SPECIFIC DEFINITIONS As referred to in Article 2(4) 1. \u2018nutrition declaration\u2019 or \u2018nutrition labelling\u2019 means information stating the: (a) energy value; or (b) energy value and one or more of the following nutrients only: \u2014 fat (saturates, mono-unsaturates, polyunsaturates), \u2014 carbohydrate (sugars, polyols, starch), \u2014 salt, \u2014 fibre, \u2014 protein, \u2014 any of the vitamins or minerals listed in point 1 of Part A of Annex XIII, and present in significant amounts as defined in point 2 of Part A of Annex XIII, 2. \u2018fat\u2019 means total lipids, and includes phospholipids; 3. \u2018saturates\u2019 means fatty acids without double bond; 4. \u2018trans fat\u2019 means fatty acids with at least one non-conjugated (namely interrupted by at least one methylene group) carbon-carbon double bond in the trans configuration; 5. \u2018mono-unsaturates\u2019 means fatty acids with one cis double bond; 6. \u2018polyunsaturates\u2019 means fatty acids with two or more cis, cis-methylene interrupted double bonds; 7. \u2018carbohydrate\u2019 means any carbohydrate which is metabolised by humans, and includes polyols; 8. \u2018sugars\u2019 means all monosaccharides and disaccharides present in food, but excludes polyols; 9. \u2018polyols\u2019 means alcohols containing more than two hydroxyl groups; 10. \u2018protein\u2019 means the protein content calculated using the formula: protein = total Kjeldahl nitrogen \u00d7 6,25; 11. \u2018salt\u2019 means the salt equivalent content calculated using the formula: salt = sodium \u00d7 2,5; 12. \u2018fibre\u2019 means carbohydrate polymers with three or more monomeric units, which are neither digested nor absorbed in the human small intestine and belong to the following categories: \u2014 edible carbohydrate polymers naturally occurring in the food as consumed, \u2014 edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic or chemical means and which have a beneficial physiological effect demonstrated by generally accepted scientific evidence, \u2014 edible synthetic carbohydrate polymers which have a beneficial physiological effect demonstrated by generally accepted scientific evidence, 13. \u2018average value\u2019 means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary. ANNEX II SUBSTANCES OR PRODUCTS CAUSING ALLERGIES OR INTOLERANCES 1. Cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof, except: (a) wheat based glucose syrups including dextrose (1); (b) wheat based maltodextrins (1); (c) glucose syrups based on barley; (d) cereals used for making alcoholic distillates including ethyl alcohol of agricultural origin; 2. Crustaceans and products thereof; 3. Eggs and products thereof; 4. Fish and products thereof, except: (a) fish gelatine used as carrier for vitamin or carotenoid preparations; (b) fish gelatine or Isinglass used as fining agent in beer and wine; 5. Peanuts and products thereof; 6. Soybeans and products thereof, except: (a) fully refined soybean oil and fat (1); (b) natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, and natural D-alpha tocopherol succinate from soybean sources; (c) vegetable oils derived phytosterols and phytosterol esters from soybean sources; (d) plant stanol ester produced from vegetable oil sterols from soybean sources; 7. Milk and products thereof (including lactose), except: (a) whey used for making alcoholic distillates including ethyl alcohol of agricultural origin; (b) lactitol; 8. Nuts, namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia), and products thereof, except for nuts used for making alcoholic distillates including ethyl alcohol of agricultural origin; 9. Celery and products thereof; 10. Mustard and products thereof; 11. Sesame seeds and products thereof; 12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers; 13. Lupin and products thereof; 14. Molluscs and products thereof. (1) And the products thereof, in so far as the process that they have undergone is not likely to increase the level of allergenicity assessed by the Authority for the relevant product from which they originated. ANNEX III FOODS FOR WHICH THE LABELLING MUST INCLUDE ONE OR MORE ADDITIONAL PARTICULARS TYPE OR CATEGORY OF FOOD PARTICULARS 1. Foods packaged in certain gases 1.1. Foods whose durability has been extended by means of packaging gases authorised pursuant to Regulation (EC) No 1333/2008. \u2018packaged in a protective atmosphere\u2019. 2. Foods containing sweeteners 2.1. Foods containing a sweetener or sweeteners authorised pursuant to Regulation (EC) No 1333/2008. \u2018with sweetener(s)\u2019 this statement shall accompany the name of the food. 2.2. Foods containing both an added sugar or sugars and a sweetener or sweeteners authorised pursuant to Regulation (EC) No 1333/2008. \u2018with sugar(s) and sweetener(s)\u2019 this statement shall accompany the name of the food. 2.3. Foods containing aspartame/aspartame-acesulfame salt authorised pursuant to Regulation EC) No 1333/2008. \u2018contains aspartame (a source of phenylalanine)\u2019 shall appear on the label in cases where aspartame/aspartame-acesulfame salt is designated in the list of ingredients only by reference to the E number. \u2018contains a source of phenylalanine\u2019 shall appear on the label in cases where aspartame/aspartame-acesulfame salt is designated in the list of ingredients by its specific name. 2.4. Foods containing more than 10 % added polyols authorised pursuant to Regulation (EC) No 1333/2008. \u2018excessive consumption may produce laxative effects\u2019. 3. Foods containing glycyrrhizinic acid or its ammonium salt 3.1. Confectionery or beverages containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plant Glycyrrhiza glabra, at concentration of 100 mg/kg or 10 mg/l or above. \u2018contains liquorice\u2019 shall be added immediately after the list of ingredients, unless the term \u2018liquorice\u2019 is already included in the list of ingredients or in the name of the food. In the absence of a list of ingredients, the statement shall accompany the name of the food. 3.2. Confectionary containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plant Glycyrrhiza glabra at concentrations of 4 g/kg or above. \u2018contains liquorice \u2013 people suffering from hypertension should avoid excessive consumption\u2019 shall be added immediately after the list of ingredients. In the absence of a list of ingredients, the statement shall accompany the name of the food. 3.3. Beverages containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plant Glycyrrhiza glabra at concentrations of 50 mg/l or above, or of 300 mg/l or above in the case of beverages containing more than 1,2 % by volume of alcohol (1). \u2018contains liquorice \u2013 people suffering from hypertension should avoid excessive consumption\u2019 shall be added immediately after the list of ingredients. In the absence of a list of ingredients, the statement shall accompany the name of the food. 4. Beverages with high caffeine content or foods with added caffeine 4.1. Beverages, with the exception of those based on coffee, tea or coffee or tea extract where the name of the food includes the term \u2018coffee\u2019 or \u2018tea\u2019, which: \u2014 are intended for consumption without modification and contain caffeine, from whatever source, in a proportion in excess of 150 mg/l, or, \u2014 are in concentrated or dried form and after reconstitution contain caffeine, from whatever source, in a proportion in excess of 150 mg/l, \u2018High caffeine content. Not recommended for children or pregnant or breast-feeding women\u2019 in the same field of vision as the name of the beverage, followed by a reference in brackets and in accordance with Article 13(1) of this Regulation to the caffeine content expressed in mg per 100 ml. 4.2. Foods other than beverages, where caffeine is added with a physiological purpose. \u2018Contains caffeine. Not recommended for children or pregnant women\u2019 in the same field of vision as the name of the food, followed by a reference in brackets and in accordance with Article 13(1) of this Regulation to the caffeine content expressed in mg per 100 g/ml. In the case of food supplements, the caffeine content shall be expressed per portion as recommended for daily consumption on the labelling. 5. Foods with added phytosterols, phytosterol esters, phytostanols or phytostanol esters 5.1. Foods or food ingredients with added phytosterols, phytosterol esters, phytostanols or phytostanol esters. (1) \u2018with added plant sterols\u2019 or \u2018with added plant stanols\u2019 in the same field of vision as the name of the food; (2) the amount of added phytosterols, phytosterol esters, phytostanols or phytostanol esters content (expressed in % or as g of free plant sterols/plant stanols per 100 g or 100 ml of the food) shall be stated in the list of ingredients; (3) a statement that the food is intended exclusively for people who want to lower their blood cholesterol level; (4) a statement that patients on cholesterol lowering medication should only consume the product under medical supervision; (5) an easily visible statement that the food may not be nutritionally appropriate for pregnant or breastfeeding women and children under the age of 5 years; (6) advice that the food is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels; (7) in the same field of vision as the statement required under point (3) above, a statement that the consumption of more than 3 g/day of added plant sterols/plant stanols should be avoided; (8) a definition of a portion of the food or food ingredient concerned (preferably in g or ml) with the amount of the plant sterol/plant stanol that each portion contains. 6. Frozen meat, frozen meat preparations and frozen unprocessed fishery products 6.1. Frozen meat, frozen meat preparations and frozen unprocessed fishery products. the date of freezing or the date of first freezing in cases where the product has been frozen more than once, in accordance with point (3) of Annex X. (1) The level shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers. ANNEX IV DEFINITION OF x-HEIGHT x-HEIGHT Legend 1 Ascender line 2 Cap line 3 Mean line 4 Baseline 5 Descender line 6 x-height 7 Font size ANNEX V FOODS WHICH ARE EXEMPTED FROM THE REQUIREMENT OF THE MANDATORY NUTRITION DECLARATION 1. Unprocessed products that comprise a single ingredient or category of ingredients; 2. Processed products which the only processing they have been subjected to is maturing and that comprise a single ingredient or category of ingredients; 3. Waters intended for human consumption, including those where the only added ingredients are carbon dioxide and/or flavourings; 4. A herb, a spice or mixtures thereof; 5. Salt and salt substitutes; 6. Table top sweeteners; 7. Products covered by Directive 1999/4/EC of the European Parliament and of the Council of 22 February 1999 relating to coffee extracts and chicory extracts (1), whole or milled coffee beans and whole or milled decaffeinated coffee beans; 8. Herbal and fruit infusions, tea, decaffeinated tea, instant or soluble tea or tea extract, decaffeinated instant or soluble tea or tea extract, which do not contain other added ingredients than flavourings which do not modify the nutritional value of the tea; 9. Fermented vinegars and substitutes for vinegar, including those where the only added ingredients are flavourings; 10. Flavourings; 11. Food additives; 12. Processing aids; 13. Food enzymes; 14. Gelatine; 15. Jam setting compounds; 16. Yeast; 17. Chewing-gums; 18. Food in packaging or containers the largest surface of which has an area of less than 25 cm2; 19. Food, including handcrafted food, directly supplied by the manufacturer of small quantities of products to the final consumer or to local retail establishments directly supplying the final consumer. (1) OJ L 66, 13.3.1999, p. 26. ANNEX VI NAME OF THE FOOD AND SPECIFIC ACCOMPANYING PARTICULARS PART A \u2014 MANDATORY PARTICULARS ACCOMPANYING THE NAME OF THE FOOD 1. The name of the food shall include or be accompanied by particulars as to the physical condition of the food or the specific treatment which it has undergone (for example, powdered, refrozen, freeze-dried, quick-frozen, concentrated, smoked) in all cases where omission of such information could mislead the purchaser. 2. In the case of foods that have been frozen before sale and which are sold defrosted, the name of the food shall be accompanied by the designation \u2018defrosted\u2019. This requirement shall not apply to the following: (a) ingredients present in the final product; (b) foods for which freezing is a technologically necessary step of the production process; (c) foods for which the defrosting has no negative impact on the safety or quality of the food. This point shall apply without prejudice to point 1. 3. Foods treated with ionising radiation shall bear one of the following indications: \u2018irradiated\u2019 or \u2018treated with ionising radiation\u2019, and other indications as stated in Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation (1). 4. In the case of foods in which a component or ingredient that consumers expect to be normally used or naturally present has been substituted with a different component or ingredient, the labelling shall bear \u2014 in addition to the list of ingredients \u2014 a clear indication of the component or the ingredient that has been used for the partial or whole substitution: (a) in close proximity to the name of the product; and (b) using a font size which has an x-height of at least 75 % of the x-height of the name of the product and which is not smaller than the minimum font size required in Article 13(2) of this Regulation. 5. In the case of meat products, meat preparations and fishery products containing added proteins as such, including hydrolysed proteins, of a different animal origin, the name of the food shall bear an indication of the presence of those proteins and of their origin. 6. In the case of meat products and meat preparations which have the appearance of a cut, joint, slice, portion or carcase of meat, the name of the food shall include an indication of the presence of added water if the added water makes up more than 5 % of the weight of the finished product. The same rules shall apply in the case of fishery products and prepared fishery products which have the appearance of a cut, joint, slice, portion, filet or of a whole fishery product. 7. Meat products, meat preparations and fishery products which may give the impression that they are made of a whole piece of meat or fish, but actually consist of different pieces combined together by other ingredients, including food additives and food enzymes or by other means, shall bear the following indication: in Bulgarian : \u2018\u0444\u043e\u0440\u043c\u043e\u0432\u0430\u043d\u043e \u043c\u0435\u0441\u043e\u2019 and \u2018\u0444\u043e\u0440\u043c\u043e\u0432\u0430\u043d\u0430 \u0440\u0438\u0431\u0430\u2019; in Spanish : \u2018combinado de piezas de carne\u2019 and \u2018combinado de piezas de pescado\u2019; in Czech : \u2018ze spojovan\u00fdch kousk\u016f masa\u2019 and \u2018ze spojovan\u00fdch kousk\u016f ryb\u00edho masa\u2019; in Danish : \u2018Sammensat af stykker af k\u00f8d\u2019 and \u2018Sammensat af stykker af fisk\u2019; in German : \u2018aus Fleischst\u00fccken zusammengef\u00fcgt\u2019 and \u2018aus Fischst\u00fccken zusammengef\u00fcgt\u2019; in Estonian : \u2018liidetud liha\u2019 and \u2018liidetud kala\u2019; in Greek : \u2018\u03bc\u03bf\u03c1\u03c6\u03bf\u03c0\u03bf\u03b9\u03b7\u03bc\u03ad\u03bd\u03bf \u03ba\u03c1\u03ad\u03b1\u03c2\u2019 and \u2018\u03bc\u03bf\u03c1\u03c6\u03bf\u03c0\u03bf\u03b9\u03b7\u03bc\u03ad\u03bd\u03bf \u03c8\u03ac\u03c1\u03b9\u2019; in English : \u2018formed meat\u2019 and \u2018formed fish\u2019; in French : \u2018viande reconstitu\u00e9e\u2019 and \u2018poisson reconstitu\u00e9\u2019; in Irish : \u2018p\u00edosa\u00ed feola ceangailte\u2019 and \u2018p\u00edosa\u00ed \u00e9isc ceangailte\u2019; in Italian : \u2018carne ricomposta\u2019 and \u2018pesce ricomposto\u2019; in Latvian : \u2018form\u0113ta ga\u013ca\u2019 and \u2018form\u0113ta zivs\u2019; in Lithuanian : \u2018sudarytas (-a) i\u0161 m\u0117sos gabal\u0173\u2019 and \u2018sudarytas (-a) i\u0161 \u017euvies gabal\u0173\u2019; in Hungarian : \u2018darabokb\u00f3l \u00fajraform\u00e1zott h\u00fas\u2019 and \u2018darabokb\u00f3l \u00fajraform\u00e1zott hal\u2019; in Maltese : \u2018la\u0127am rikostitwit\u2019 and \u2018\u0127ut rikostitwit\u2019; in Dutch : \u2018samengesteld uit stukjes vlees\u2019 and \u2018samengesteld uit stukjes vis\u2019; in Polish : \u2018z po\u0142\u0105czonych kawa\u0142k\u00f3w mi\u0119sa\u2019 and \u2018z po\u0142\u0105czonych kawa\u0142k\u00f3w ryby\u2019; in Portuguese : \u2018carne reconstitu\u00edda\u2019 and \u2018peixe reconstitu\u00eddo\u2019; in Romanian : \u2018carne format\u0103\u2019 and \u2018carne de pe\u0219te format\u0103\u2019; in Slovak : \u2018sp\u00e1jan\u00e9 alebo formovan\u00e9 m\u00e4so\u2019 and \u2018sp\u00e1jan\u00e9 alebo formovan\u00e9 ryby\u2019; in Slovenian : \u2018sestavljeno, iz ko\u0161\u010dkov oblikovano meso\u2019 and \u2018sestavljene, iz ko\u0161\u010dkov oblikovane ribe\u2019; in Finnish : \u2018paloista yhdistetty liha\u2019 and \u2018paloista yhdistetty kala\u2019; in Swedish : \u2018sammanfogade bitar av k\u00f6tt\u2019 and \u2018sammanfogade bitar av fisk\u2019. PART B \u2014 SPECIFIC REQUIREMENTS CONCERNING THE DESIGNATION OF \u2018MINCED MEAT\u2019 1. Composition criteria checked on the basis of a daily average: Fat content Collagen/meat protein ratio (2) \u2014 lean minced meat, \u2264 7 % \u2264 12 % \u2014 minced pure beef, \u2264 20 % \u2264 15 % \u2014 minced meat containing pigmeat, \u2264 30 % \u2264 18 % \u2014 minced meat of other species, \u2264 25 % \u2264 15 % 2. In addition to the requirements laid down in Chapter IV of Section V of Annex III to Regulation (EC) No 853/2004, the following expressions shall appear on the labelling: \u2014 \u2018percentage of fat content under \u2026\u2019, \u2014 \u2018collagen/meat protein ratio under \u2026\u2019, 3. The Member States may allow the placing on their national market of minced meat which does not comply with the criteria laid down in point 1 of this Part under a national mark that cannot be confused with the marks provided for in Article 5(1) of Regulation (EC) No 853/2004. PART C \u2014 SPECIFIC REQUIREMENTS CONCERNING THE DESIGNATION OF SAUSAGE CASINGS If a sausage casing is not edible, this must be indicated. (1) OJ L 66, 13.3.1999, p. 16. (2) The collagen/meat protein ratio is expressed as the percentage of collagen in meat protein. The collagen content means the hydroxyproline content multiplied by a factor of 8. ANNEX VII INDICATION AND DESIGNATION OF INGREDIENTS PART A \u2014 SPECIFIC PROVISIONS CONCERNING THE INDICATION OF INGREDIENTS BY DESCENDING ORDER OF WEIGHT Category of ingredient Provision concerning indication by weight 1. Added water and volatile products Shall be listed in order of their weight in the finished product. The amount of water added as an ingredient in a food shall be calculated by deducting from the total amount of the finished product the total amount of the other ingredients used. This amount shall not be required to be taken into consideration if it does not exceed 5 % by weight of the finished product. This derogation does not apply to meat, meat preparations, unprocessed fishery products and unprocessed bivalve molluscs 2. Ingredients used in concentrated or dehydrated form and reconstituted at the time of manufacture May be listed in order of weight as recorded before their concentration or dehydration 3. Ingredients used in concentrated or dehydrated foods, which are intended to be reconstituted by the addition of water May be listed in order of proportion in the reconstituted product provided that the list of ingredients is accompanied by an expression, such as \u2018ingredients of the reconstituted product\u2019, or \u2018ingredients of the ready-to-use product\u2019 4. Fruit, vegetables or mushrooms, none of which significantly predominates in terms of weight and which are used in proportions that are likely to vary, used in a mixture as ingredients of a food May be grouped together in the list of ingredients under the designation \u2018fruit\u2019, \u2018vegetables\u2019 or \u2018mushrooms\u2019 followed by the phrase \u2018in varying proportions\u2019, immediately followed by a list of the fruit, vegetables or mushrooms present. In such cases, the mixture shall be included in the list of ingredients in accordance with Article 18(1), on the basis of the total weight of the fruit, vegetables or mushrooms present 5. Mixtures of spices or herbs, where none significantly predominates in proportion by weight May be listed in different order provided that that list of ingredients is accompanied by an expression such as \u2018in variable proportion\u2019 6. Ingredients constituting less than 2 % of the finished product May be listed in a different order after the other ingredients 7. Ingredients, which are similar or mutually substitutable, likely to be used in the manufacture or preparation of a food without altering its composition, its nature or its perceived value, and in so far as they constitute less than 2 % of the finished product May be referred to in the list of ingredients by means of the statement \u2018contains \u2026 and/or \u2026\u2019, where at least one of no more than two ingredients is present in the finished product. This provision shall not apply to food additives or to ingredients listed in Part C of this Annex, and to substances or products listed in Annex II causing allergies or intolerances 8. Refined oils of vegetable origin May be grouped together in the list of ingredients under the designation \u2018vegetable oils\u2019 followed immediately by a list of indications of specific vegetable origin, and may be followed by the phrase \u2018in varying proportions\u2019. If grouped together, vegetable oils shall be included in the list of ingredients in accordance with Article 18(1), on the basis of the total weight of the vegetable oils present. The expression \u2018fully hydrogenated\u2019 or \u2018partly hydrogenated\u2019, as appropriate, must accompany the indication of a hydrogenated oil 9. Refined fats of vegetable origin May be grouped together in the list of ingredients under the designation \u2018vegetable fats\u2019 followed immediately by a list of indications of specific vegetable origin, and may be followed by the phrase \u2018in varying proportions\u2019. If grouped together, vegetable fats shall be included in the list of ingredients in accordance with Article 18(1), on the basis of the total weight of the vegetable fats present. The expression \u2018fully hydrogenated\u2019 or \u2018partly hydrogenated\u2019, as appropriate, must accompany the indication of a hydrogenated fat PART B \u2014 DESIGNATION OF CERTAIN INGREDIENTS BY THE NAME OF A CATEGORY RATHER THAN A SPECIFIC NAME Without prejudice to Article 21, ingredients which belong to one of the categories of foods listed below and are constituents of another food may be designated by the name of that category rather than the specific name. Definition of category of food Designation 1. Refined oils of animal origin \u2018Oil\u2019, together with either the adjective \u2018animal\u2019, or the indication of specific animal origin. The expression \u2018fully hydrogenated\u2019 or \u2018partly hydrogenated\u2019, as appropriate, must accompany the indication of a hydrogenated oil 2. Refined fats of animal origin \u2018Fat\u2019, together with either the adjective \u2018animal\u2019 or the indication of specific animal origin. The expression \u2018fully hydrogenated\u2019 or \u2018partly hydrogenated\u2019, as appropriate, must accompany the indication of a hydrogenated fat 3. Mixtures of flour obtained from two or more cereal species \u2018Flour\u2019, followed by a list of the cereals from which it has been obtained, in descending order by weight 4. Starches, and starches modified by physical means or by enzymes \u2018Starch\u2019 5. All species of fish where the fish constitutes an ingredient of another food and provided that the name and presentation of such food does not refer to a specific species of fish \u2018Fish\u2019 6. All types of cheese where the cheese or mixture of cheeses constitutes an ingredient of another food and provided that the name and presentation of such food does not refer to a specific type of cheese \u2018Cheese\u2019 7. All spices not exceeding 2 % by weight of the food \u2018Spice(s)\u2019 or \u2018mixed spices\u2019 8. All herbs or parts of herbs not exceeding 2 % by weight of the food \u2018Herb(s)\u2019 or \u2018mixed herbs\u2019 9. All types of gum preparations used in the manufacture of gum base for chewing gum \u2018Gum base\u2019 10. All types of crumbed baked cereal products \u2018Crumbs\u2019 or \u2018rusks\u2019 as appropriate 11. All types of sucrose \u2018Sugar\u2019 12. Anhydrous dextrose or dextrose monohydrate \u2018Dextrose\u2019 13. Glucose syrup and anhydrous glucose syrup \u2018Glucose syrup\u2019 14. All types of milk protein (caseins, caseinates and whey proteins) and mixtures thereof \u2018Milk proteins\u2019 15. Press, expeller or refined cocoa butter \u2018Cocoa butter\u2019 16. All types of wine as covered by Annex XIb to Regulation (EC) No 1234/2007 (1) \u2018Wine\u2019 17. Skeletal muscles (2) of mammalian and bird species recognised as fit for human consumption with naturally included or adherent tissue, where the total fat and connective tissue content does not exceed the values indicated below and where the meat constitutes an ingredient of another food. Maximum fat and connective tissue contents for ingredients designated by the term \u2018\u2026 meat\u2019 Species Fat content Collagen/meat protein ratio (4) \u2014 Mammals (other than rabbits and porcines) and mixtures of species with mammals predominating, 25 % 25 % \u2014 Porcines, 30 % 25 % \u2014 Birds and rabbits, 15 % 10 % If these maximum limits are exceeded, but all other criteria for the definition of \u2018meat\u2019 are satisfied, the \u2018\u2026 meat\u2019 content must be adjusted downwards accordingly and the list of ingredients must mention, in addition to the term \u2018\u2026 meat\u2019, the presence of fat and/or connective tissue. The products covered by the definition of \u2018mechanically separated meat\u2019 are excluded from this definition \u2018\u2026 meat\u2019 and the name(s) (3) of the animal species from which it comes 18. All types of products covered by the definition of \u2018mechanically separated meat\u2019 \u2018mechanically separated meat\u2019 and the name(s) (3) of the animal species from which it comes PART C \u2014 DESIGNATION OF CERTAIN INGREDIENTS BY THE NAME OF THEIR CATEGORY FOLLOWED BY THEIR SPECIFIC NAME OR E NUMBER Without prejudice to Article 21, food additives and food enzymes other than those specified in point (b) of Article 20 belonging to one of the categories listed in this Part must be designated by the name of that category, followed by their specific name or, if appropriate, E number. If an ingredient belongs to more than one of the categories, the category appropriate to the principal function in the case of the food in question shall be indicated. Acid Acidity regulator Anti-caking agent Anti-foaming agent Antioxidant Bulking agent Colour Emulsifier Emulsifying salts (5) Firming agent Flavour enhancer Flour treatment agent Foaming agent Gelling agent Glazing agent Humectant Modified starch (6) Preservative Propellent gas Raising agent Sequestrant Stabiliser Sweetener Thickener PART D \u2014 DESIGNATION OF FLAVOURINGS IN THE LIST OF INGREDIENTS 1. Flavourings shall be designated either by the terms: \u2014 \u2018flavouring(s)\u2019 or by a more specific name or description of the flavouring if the flavouring component contains flavourings as defined in points (b), (c), (d), (e), (f), (g) and (h) of Article 3(2) of Regulation (EC) No 1334/2008, \u2014 \u2018smoke flavouring(s)\u2019, or \u2018smoke flavouring(s) produced from food(s) or food category or source(s)\u2019 (e.g. \u2018smoke flavouring produced from beech\u2019), if the flavouring component contains flavourings as defined in point (f) of Article 3(2) of Regulation (EC) No 1334/2008 and imparts a smoky flavour to the food. 2. The term \u2018natural\u2019 for the description of flavourings shall be used in accordance with Article 16 of Regulation (EC) No 1334/2008. 3. Quinine and/or caffeine used as a flavouring in the production or preparation of a food shall be mentioned by name in the list of ingredients immediately after the term \u2018flavouring(s)\u2019. PART E \u2014 DESIGNATION OF COMPOUND INGREDIENTS 1. A compound ingredient may be included in the list of ingredients, under its own designation in so far as this is laid down by law or established by custom, in terms of its overall weight, and immediately followed by a list of its ingredients. 2. Without prejudice to Article 21, the list of ingredients for compound ingredients shall not be compulsory: (a) where the composition of the compound ingredient is defined in current Union provisions, and in so far as the compound ingredient constitutes less than 2 % of the finished product; however, this provision shall not apply to food additives, subject to points (a) to (d) of Article 20; (b) for compound ingredients consisting of mixtures of spices and/or herbs that constitute less than 2 % of the finished product, with the exception of food additives, subject to points (a) to (d) of Article 20; or (c) where the compound ingredient is a food for which a list of ingredients is not required under Union provisions. (1) Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (OJ L 299, 16.11.2007, p. 1). (2) The diaphragm and the masseters are part of the skeletal muscles, while the heart, tongue, the muscles of the head (other than the masseters), the muscles of the carpus, the tarsus and the tail are excluded. (3) For labelling in English, this designation may be replaced by the generic name of the ingredient for the animal species concerned. (4) The collagen/meat protein ratio is expressed as the percentage of collagen in meat protein. The collagen content means the hydroxyproline content multiplied by a factor of 8. (5) Only for processed cheeses and products based on processed cheeses. (6) The specific name or E number shall not be required to be indicated. ANNEX VIII QUANTITATIVE INDICATION OF INGREDIENTS 1. The quantitative indication shall not be required: (a) in respect of an ingredient or category of ingredients: (i) the drained net weight of which is indicated in accordance with point 5 of Annex IX; (ii) the quantities of which must already appear on the labelling under Union provisions; (iii) which is used in small quantities for the purposes of flavouring; or (iv) which, while appearing in the name of the food, is not such as to govern the choice of the consumer in the country of marketing because the variation in quantity is not essential to characterise the food or does not distinguish it from similar foods; (b) where specific Union provisions stipulate precisely the quantity of an ingredient or of a category of ingredients without providing for the indication thereof on the labelling; or (c) in the cases referred to in points 4 and 5 of Part A of Annex VII. 2. Points (a) and (b) of Article 22(1) shall not apply in the case of: (a) any ingredient or category of ingredients covered by the indication \u2018with sweetener(s)\u2019 or \u2018with sugar(s) and sweetener(s)\u2019 if that indication accompanies the name of the food, pursuant Annex III; or (b) any added vitamin and mineral if that substance is subject to a nutrition declaration. 3. The indication of quantity of an ingredient or category of ingredients shall: (a) be expressed as a percentage, which shall correspond to the quantity of the ingredient or ingredients at the time of its/their use; and (b) appear either in or immediately next to the name of the food or in the list of ingredients in connection with the ingredient or category of ingredients in question. 4. By way of derogation from point 3: (a) where foods have lost moisture following heat treatment or other treatment, the quantity shall be expressed as a percentage which shall correspond to the quantity of the ingredient(s) used, related to the finished product, unless that quantity or the total quantity of all the ingredients indicated on the labelling exceeds 100 %, in which case the quantity shall be indicated on the basis of the weight of the ingredient(s) used to prepare 100 g of finished product; (b) the quantity of volatile ingredients shall be indicated on the basis of their proportion by weight in the finished product; (c) the quantity of ingredients used in concentrated or dehydrated form and reconstituted during manufacture may be indicated on the basis of their proportion by weight as recorded before their concentration or dehydration; (d) in the case of concentrated or dehydrated foods which are intended to be reconstituted by the addition of water, the quantity of the ingredients may be indicated on the basis of their proportion by weight in the reconstituted product. ANNEX IX NET QUANTITY DECLARATION 1. The net quantity declaration shall not be mandatory in the case of foods: (a) which are subject to considerable losses in their volume or mass and which are sold by number or weighed in the presence of the purchaser; (b) the net quantity of which is less than 5 g or 5 ml; however, this provision shall not apply to spices and herbs; or (c) normally sold by number, provided that the number of items can clearly be seen and easily counted from the outside or, if not, is indicated on the labelling. 2. Where the indication of a certain type of quantity (such as the nominal quantity, minimum quantity, or average quantity) is required by Union provisions or, where there are none, by national provisions, this quantity shall be regarded as the net quantity for the purposes of this Regulation. 3. Where a prepacked item consists of two or more individual prepacked items containing the same quantity of the same product, the net quantity shall be indicated by mentioning the net quantity contained in each individual package and the total number of such packages. The indication of those particulars shall not, however, be mandatory where the total number of individual packages can be clearly seen and easily counted from the outside and where at least one indication of the net quantity contained in each individual package can be clearly seen from the outside. 4. Where a prepacked item consists of two or more individual packages which are not regarded as units of sale, the net quantity shall be given by indicating the total net quantity and the total number of individual packages. 5. Where a solid food is presented in a liquid medium, the drained net weight of the food shall also be indicated. Where the food has been glazed, the declared net weight of the food shall be exclusive of the glaze. For the purposes of this point, \u2018liquid medium\u2019 shall mean the following products, possibly in mixtures and also where frozen or quick-frozen, provided that the liquid is merely an adjunct to the essential elements of that preparation and is thus not a decisive factor for the purchase: water, aqueous solutions of salts, brine, aqueous solutions of food acids, vinegar, aqueous solutions of sugars, aqueous solutions of other sweetening substances, fruit or vegetable juices in the case of fruit or vegetables. ANNEX X DATE OF MINIMUM DURABILITY, \u2018USE BY\u2019 DATE AND DATE OF FREEZING 1. The date of minimum durability shall be indicated as follows: (a) the date shall be preceded by the words: \u2014 \u2018Best before \u2026\u2019 when the date includes an indication of the day, \u2014 \u2018Best before end \u2026\u2019 in other cases, (b) the words referred to in point (a) shall be accompanied by: \u2014 either the date itself, or, \u2014 a reference to where the date is given on the labelling, If need be, these particulars shall be followed by a description of the storage conditions which must be observed if the product is to keep for the specified period; (c) the date shall consist of the day, the month and possibly, the year, in that order and in uncoded form. However, in the case of foods: \u2014 which will not keep for more than 3 months, an indication of the day and the month shall be sufficient, \u2014 which will keep for more than 3 months but not more than 18 months, an indication of the month and year shall be sufficient, \u2014 which will keep for more than 18 months, an indication of the year shall be sufficient, (d) subject to Union provisions imposing other types of date indication, an indication of the date of minimum durability shall not be required for: \u2014 fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated; this derogation shall not apply to sprouting seeds and similar products such as legume sprouts, \u2014 wines, liqueur wines, sparkling wines, aromatised wines, and similar products obtained from fruit other than grapes, and beverages falling within CN code 2206 00 obtained from grapes or grape musts, \u2014 beverages containing 10 % or more by volume of alcohol, \u2014 bakers\u2019 or pastry cooks\u2019 wares which, given the nature of their content, are normally consumed within 24 hours of their manufacture, \u2014 vinegar, \u2014 cooking salt, \u2014 solid sugar, \u2014 confectionery products consisting almost solely of flavoured and/or coloured sugars, \u2014 chewing gums and similar chewing products, 2. The \u2018use by\u2019 date shall be indicated as follows: (a) it shall be preceded by the words \u2018use by \u2026\u2019; (b) the words in point (a) shall be accompanied by: \u2014 either the date itself, or, \u2014 a reference to where the date is given on the labelling, Those particulars shall be followed by a description of the storage conditions which must be observed; (c) the date shall consist of the day, the month and, possibly, the year, in that order and in uncoded form; (d) the \u2018use by\u2019 date shall be indicated on each individual prepacked portion. 3. The date of freezing or the date of first freezing as referred to in point 6 of Annex III shall be indicated as follows: (a) it shall be preceded by the words \u2018Frozen on \u2026\u2019; (b) the words referred to in point (a) shall be accompanied by: \u2014 the date itself, or, \u2014 a reference to where the date is given on the labelling, (c) the date shall consist of the day, the month and the year, in that order and in uncoded form. ANNEX XI TYPES OF MEAT FOR WHICH THE INDICATION OF THE COUNTRY OF ORIGIN OR PLACE OF PROVENANCE IS MANDATORY CN codes (Combined Nomenclature 2010) Description 0203 Meat of swine, fresh, chilled or frozen 0204 Meat of sheep or goats, fresh, chilled or frozen Ex02 07 Meat of the poultry of heading 0105 , fresh, chilled or frozen ANNEX XII ALCOHOLIC STRENGTH The actual alcoholic strength by volume of beverages containing more than 1,2 % by volume of alcohol shall be indicated by a figure to not more than one decimal place. It shall be followed by the symbol \u2018% vol.\u2019 and may be preceded by the word \u2018alcohol\u2019 or the abbreviation \u2018alc\u2019. The alcoholic strength shall be determined at 20 \u00b0C. Positive and negative allowed tolerances in respect of the indication of the alcoholic strength by volume and expressed in absolute values shall be as listed in the following table. They shall apply without prejudice to the tolerances deriving from the method of analysis used for determining the alcoholic strength. Description of beverage Positive or negative tolerance 1. Beers of CN code 2203 00 having an alcoholic strength not exceeding 5,5 % vol.; still beverages falling within CN code 2206 00 obtained from grapes 0,5 % vol. 2. Beers having an alcoholic strength exceeding 5,5 % vol.; sparkling beverages falling within CN code 2206 00 obtained from grapes, ciders, perries, fruit wines and the like, obtained from fruit other than grapes, whether or not semi-sparkling or sparkling; mead 1 % vol. 3. Beverages containing macerated fruit or parts of plants 1,5 % vol. 4. Any other beverages containing more than 1,2 % by volume of alcohol 0,3 % vol. ANNEX XIII REFERENCE INTAKES PART A \u2014 DAILY REFERENCE INTAKES FOR VITAMINS AND MINERALS (ADULTS) 1. Vitamins and minerals which may be declared and their nutrient reference values (NRVs) Vitamin A (\u03bcg) 800 Vitamin D (\u03bcg) 5 Vitamin E (mg) 12 Vitamin K (\u03bcg) 75 Vitamin C (mg) 80 Thiamin (mg) 1,1 Riboflavin (mg) 1,4 Niacin (mg) 16 Vitamin B6 (mg) 1,4 Folic acid (\u03bcg) 200 Vitamin B12 (\u03bcg) 2,5 Biotin (\u03bcg) 50 Pantothenic acid (mg) 6 Potassium (mg) 2 000 Chloride (mg) 800 Calcium (mg) 800 Phosphorus (mg) 700 Magnesium (mg) 375 Iron (mg) 14 Zinc (mg) 10 Copper (mg) 1 Manganese (mg) 2 Fluoride (mg) 3,5 Selenium(\u03bcg) 55 Chromium (\u03bcg) 40 Molybdenum (\u03bcg) 50 Iodine (\u03bcg) 150 2. Significant amount of vitamins and minerals As a rule, the following values should be taken into consideration in deciding what constitutes a significant amount: \u2014 15 % of the nutrient reference values specified in point 1 supplied by 100 g or 100 ml in the case of products other than beverages, \u2014 7,5 % of the nutrient reference values specified in point 1 supplied by 100 ml in the case of beverages, or, \u2014 15 % of the nutrient reference values specified in point 1 per portion if the package contains only a single portion, PART B \u2014 REFERENCE INTAKES FOR ENERGY AND SELECTED NUTRIENTS OTHER THAN VITAMINS AND MINERALS (ADULTS) Energy or nutrient Reference intake Energy 8 400 kJ/2 000 kcal Total fat 70 g Saturates 20 g Carbohydrate 260 g Sugars 90 g Protein 50 g Salt 6 g ANNEX XIV CONVERSION FACTORS CONVERSION FACTORS FOR THE CALCULATION OF ENERGY The energy value to be declared shall be calculated using the following conversion factors: \u2014 carbohydrate (except polyols), 17 kJ/g \u2014 4 kcal/g \u2014 polyols, 10 kJ/g \u2014 2,4 kcal/g \u2014 protein, 17 kJ/g \u2014 4 kcal/g \u2014 fat, 37 kJ/g \u2014 9 kcal/g \u2014 salatrims, 25 kJ/g \u2014 6 kcal/g \u2014 alcohol (ethanol), 29 kJ/g \u2014 7 kcal/g \u2014 organic acid, 13 kJ/g \u2014 3 kcal/g \u2014 fibre, 8 kJ/g \u2014 2 kcal/g \u2014 erythritol, 0 kJ/g \u2014 0 kcal/g ANNEX XV EXPRESSION AND PRESENTATION OF NUTRITION DECLARATION The units of measurement to be used in the nutrition declaration for energy (kilojoules (kJ) and kilocalories (kcal)) and mass (grams (g), milligrams (mg) or micrograms (\u03bcg)) and the order of presentation of the information, as appropriate, shall be the following: energy kJ/kcal fat g of which \u2014 saturates, g \u2014 mono-unsaturates, g \u2014 polyunsaturates, g carbohydrate g of which \u2014 sugars, g \u2014 polyols, g \u2014 starch, g fibre g protein g salt g vitamins and minerals the units specified in point 1 of Part A of Annex XIII", "summary": "Labelling of foodstuffs Labelling of foodstuffs SUMMARY OF: Regulation (EU) No 1169/2011 on providing food information to consumers WHAT IS THE AIM OF THE REGULATION? It seeks to guarantee consumers their right to information by establishing the general principles, requirements and responsibilities for the labelling of foodstuffs they consume. It provides sufficient flexibility to respond to future developments in the food sector. It merges the previous legislation, Directives 2000/13/EC on the labelling of foodstuffs and 90/496/EEC on nutritional labelling. KEY POINTS Scope The legislation applies to businesses at all stages of the food chain and to all foods intended for final consumption. This includes food delivered by or supplied to mass caterers. Responsibility to provide information Responsibility for providing the necessary information, and ensuring it is accurate, lies with the manufacturer marketing the food under their name. If they are based outside the European Union (EU), it lies with the importer. Mandatory information Certain information is mandatory. This includes: the food\u2019s namea list of ingredientsnet quantitya use-by dateinstructions for use, if necessarythe operator\u2019s name and addressa nutrition declaration. The general rule is that the indication of the country of origin or place of provenance is mandatory where failure to indicate this might mislead the consumer as to the true country of origin or place of provenance of the food. This is particularly the case if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance. Origin labelling must be provided for fresh, chilled and frozen meat of swine, sheep, goats and poultry. Separate EU-level mandatory origin rules exist for foods such as honey (Directive 2001/110/EC), fruit and vegetables and olive oil (Regulation (EU) No 1308/2013), fish (Regulation (EU) No 1379/2013) and beef and beef products (Regulation (EC) No 1760/2000). The mandatory information must be available at no extra cost to consumers who use distance selling to buy food, before they make their purchase. The actual alcoholic strength must be given for any drinks with more than 1.2% by volume of alcohol. Additional mandatory information must be given for certain types of foods, such as those containing sweeteners, ammonium salt or with a high caffeine count. The net quantity of food and liquids must be expressed in litres, centilitres, millilitres, kilograms or grams. Certain foods are exempt from the mandatory nutrition declaration, such as herbs and spices, flavourings and herbal teas. Other foods \u2014 notably fresh fruit and vegetables, carbonated water, vinegars, and dairy items like cheese, butter, cream and fermented milk \u2014 do not need a list of ingredients. Food information should not mislead the public, particularly by suggesting it possesses special characteristics or effects it does not have. It should be accurate, clear and easy for the consumer to understand. The European Commission adopted Implementing Regulation (EU) 2018/775, which builds on Regulation (EU) No 1169/2011\u2019s Article 26(3) by laying down detailed rules for indicating the country of origin or place of provenance of the primary ingredient of a food. In force since 1 April 2020, this regulation requires that the country of origin or place of provenance of the primary ingredient be indicated on the label if it is not the same as the given country of origin or the given place of provenance of the food. It also sets rules regarding the minimum font size and the positioning of this label. In 2018, the Commission issued a notice on questions and answers on the application of Regulation (EU) No 1169/2011 to assist food business operators and national authorities in applying the regulation. In 2020, the Commission issued a notice providing guidelines for food business operators and national authorities on applying the rules regarding labelling when the country of origin or place of provenance of a food is given and it is not the same as that of its primary ingredient, the country of origin or place of provenance. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 13 December 2014, with the exception of the introduction of a nutrition declaration (from 13 December 2016) and the specific requirements concerning the designation of \u2018minced meat\u2019 (1 January 2014), and the indication of the primary ingredient (1 April 2020). BACKGROUND The free movement of safe and wholesome food in the EU is of major benefit to the public\u2019s health and well-being and is an essential feature of the single market. In addition to guaranteeing a high level of health protection, EU law ensures that consumers have appropriate information to make informed choices in the food they buy and eat. For further information, see: Food information to consumers (European Commission). MAIN DOCUMENT Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, pp.18\u201363). Successive amendments to Regulation (EC) No 1169/2011 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission notice on the application of the provisions of Article 26(3) of Regulation (EU) No 1169/2011 (OJ C 32, 31.1.2020, pp. 1\u20138). Commission notice on questions and answers on the application of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (OJ C 196, 8.6.2018, pp. 1\u201314). Commission Implementing Regulation (EU) 2018/775 of 28 May 2018 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food (OJ L 131, 29.5.2018, pp. 8\u201311). See consolidated version. Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, pp. 671\u2013854). See consolidated version. Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, pp. 1\u201321). See consolidated version. Council Directive 2001/110/EC of 20 December 2001 relating to honey (OJ L 10, 12.1.2002, pp. 47\u201352). See consolidated version. Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, pp. 1\u201310). See consolidated version. last update 24.11.2021"}
{"article": "27.7.2012 EN Official Journal of the European Union L 201/135 REGULATION (EU) No 651/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 on the issuance of euro coins THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 133 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the Opinion of the European Central Bank (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Council conclusions of 23 November 1998 and of 5 November 2002 on euro coins intended for collection, the Commission Recommendation 2009/23/EC of 19 December 2008 on common guidelines for the national sides and the issuance of euro coins intended for circulation (3), endorsed by Council conclusions of 10 February 2009, and the Commission Recommendation 2010/191/EU of 22 March 2010 on the scope and effects of legal tender of euro banknotes and coins (4), recommend practices regarding the issuance of euro coins intended for circulation, including commemorative euro coins, consultation prior to the destruction of fit euro circulation coins and the use of euro collector coins. (2) The lack of mandatory provisions for the issuance of euro coins may result in different practices among Member States and does not achieve a sufficiently integrated framework for the single currency. In the interests of transparency and legal certainty, it is therefore necessary to introduce binding rules for the issuance of euro coins. (3) In accordance with Council Regulation (EC) No 974/98 of 3 May 1998 on the introduction of the euro (5), coins denominated in euro and cent and complying with the denominations and technical specifications laid down by the Council have the status of legal tender in all Member States whose currency is the euro. Denominations and technical specifications of euro coins are laid down in Council Regulation (EC) No 975/98 of 3 May 1998 on denominations and technical specifications of euro coins intended for circulation (6). (4) Member States whose currency is the euro should also be able to issue 2-euro commemorative coins to celebrate specific subjects, subject to limits set per year and per issuing Member State for the number of issues of such coins. It is necessary to establish certain volume limits for commemorative euro coins in order to ensure that such coins remain a minor percentage of the total number of the 2-euro coins in circulation. Such volume limits should, however, allow for the issuance of a sufficient volume of coins to ensure that commemorative euro coins can circulate effectively. (5) Member States whose currency is the euro should also be able to issue euro collector coins, which are not intended for circulation and which should be readily distinguishable from circulation coins. Euro collector coins should have the status of legal tender only in the Member State of issuance and should not be issued with a view to their entry into circulation. (6) It is appropriate that issuances of euro collector coins are accounted for in the volume of coins to be approved by the European Central Bank, but on an aggregate basis rather than for each individual issue. (7) The use of different denominations of euro coins and euro banknotes, as currently devised, should be periodically and carefully examined by the competent institutions against the criteria of cost and public acceptability. In particular, the Commission should conduct an impact assessment on the continued issuance of 1- and 2-cent coins. (8) In order to avoid that fit euro circulation coins are destroyed by one Member State while there may be a need of such coins in another, Member States should consult each other prior to the destruction of such coins, HAVE ADOPTED THIS REGULATION: Article 1 Definitions For the purposes of this Regulation, the following definitions shall apply: (1) \u2018circulation coins\u2019 means euro coins intended for circulation, the denominations and technical specifications of which are laid down in Regulation (EC) No 975/98; (2) \u2018commemorative coins\u2019 means circulation coins, which are intended to commemorate a specific subject as specified in Article 1h of Regulation (EC) No 975/98; (3) \u2018collector coins\u2019 means euro coins intended for collection that are not issued with a view to their entry into circulation. Article 2 Types of euro coin 1. Member States may issue two types of euro coin: circulation coins and collector coins. 2. The Commission shall conduct an impact assessment on the continued issuance of 1- and 2-cent coins. That impact assessment shall include a cost-benefit analysis which takes into account the real production costs of those coins set against their value and benefits. Article 3 Issuance of circulation coins 1. Circulation coins shall be issued and put into circulation at face value. 2. A minor proportion, not exceeding 5 % of the cumulated total net value and volume of circulation coins issued by a Member State, taking into account only years with positive net issuance, may be put on the market above face value if justified by the special quality of the coin, a special packaging or any additional services provided. Article 4 Issuance of commemorative coins 1. Each Member State whose currency is the euro may only issue two commemorative coins per year, save where: (a) commemorative coins are collectively issued by all Member States whose currency is the euro; or (b) a commemorative coin is issued on the occasion of a temporary vacancy or a provisional occupation of the function of Head of State. 2. The total number of commemorative coins put into circulation for each individual issue shall not exceed the higher of the following two ceilings: (a) 0,1 % of the cumulated total net number of 2-euro coins put into circulation by all Member States whose currency is the euro up to the beginning of the year preceding the year of issuance of the commemorative coin; this ceiling may be raised to 2,0 % of the cumulated total net number of 2-euro coins of all Member States whose currency is the euro if a widely recognised and highly symbolic subject is commemorated, in which case the issuing Member State shall refrain from launching another commemorative coin issue using the raised ceiling during the subsequent four years and shall set out the reasons for choosing the raised ceiling; or (b) 5,0 % of the cumulated total net number of 2-euro coins put into circulation by the Member State concerned up to the beginning of the year preceding the year of issuance of the commemorative coin. 3. The decision whether to issue commemorative coins with a common design collectively issued by all Member States whose currency is the euro shall be taken by the Council. The voting rights of the Member States whose currency is not the euro shall be suspended for the adoption of that decision. Article 5 Issuance of collector coins 1. Collector coins shall have the status of legal tender only in the issuing Member State. The identity of the issuing Member State shall be clearly and easily recognisable on the coin. 2. In order to be easily differentiated from circulation coins, collector coins shall meet all of the following criteria: (a) their face value must be different from the face values of circulation coins; (b) their images must not be similar to the common sides of circulation coins, and if their images are similar to any national side of circulation coins, their overall appearance can still be easily differentiated; (c) their colour, diameter and weight must differ significantly from circulation coins for at least two of these three characteristics; the difference shall be regarded as significant if the values including tolerances are outside the tolerance ranges fixed for circulation coins; and (d) they must not have a shaped edge with fine scallops or a \u2018Spanish flower\u2019 shape. 3. Collector coins may be put on the market at or above face value. 4. The issuances of collector coins shall be accounted for on an aggregated basis in the volume of coin issuance to be approved by the European Central Bank. 5. Member States shall take all appropriate measures to discourage the use of collector coins as a means of payment. Article 6 Consultation prior to the destruction of circulation coins Prior to the destruction of circulation coins which are not euro coins unfit for circulation within the meaning of point (b) of Article 2 of Regulation (EU) No 1210/2010 of the European Parliament and of the Council of 15 December 2010 concerning authentication of euro coins and handling of euro coins unfit for circulation (7), Member States shall consult each other via the relevant subcommittee of the Economic and Financial Committee and inform the mint directors of the Member States whose currency is the euro. Article 7 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 4 July 2012. For the European Parliament The President M. SCHULZ For the Council The President A. D. MAVROYIANNIS (1) OJ C 273, 16.9.2011, p. 2. (2) Position of the European Parliament of 22 May 2012 (not yet published in the Official Journal) and decision of the Council of 26 June 2012. (3) OJ L 9, 14.1.2009, p. 52. (4) OJ L 83, 30.3.2010, p. 70. (5) OJ L 139, 11.5.1998, p. 1. (6) OJ L 139, 11.5.1998, p. 6. (7) OJ L 339, 22.12.2010, p. 1.", "summary": "Issue of euro coins Issue of euro coins SUMMARY OF: Regulation (EU) No 651/2012 on the issuance of euro coins Regulation (EU) No 729/2014 on denominations and technical specifications of euro coins intended for circulation WHAT IS THE AIM OF THE REGULATIONS? Regulation (EU) No 651/2012 defines the types of euro coins and lays down the conditions to be respected at coin issue. Regulation (EU) No 729/2014 sets the technical requirements of the euro coins and provides for general rules on their design including design approval. KEY POINTS Regulation (EU) No 651/2012 states: governments of euro area countries (countries that have the euro as their currency) may issue circulation coins* and collector coins*; circulation coins are made available at their face value, except for a maximum of 5% which may be put on the market at a higher price because of their special qualities or packaging; national commemorative coins* may only be issued twice a year (unless the design is common to all euro area countries); the total number issued must not be above one of two possible limits, whichever is higher, as a percentage of all 2-euro coins in circulation; collector coins are only legal tender* in the issuing euro area country; must be clearly distinguishable from circulation coins in face value, images and in two of the following: colour, diameter and weight; governments of euro area countries must consult each other before destroying damaged euro coins; the Commission carries out an impact assessment, analysing the real production costs of 1- and 2-cent coins against their value and benefits. Further to Regulation (EU) No 729/2014: there are eight euro coins (1, 2, 5, 10, 20 and 50 cents and 1 and 2 euro); each coin has a distinctive national and a common European side; national sides must: bear a circle of 12 stars fully surrounding the national design; remain unchanged for 15 years, unless the country\u2019s head of state changes; not show the coin\u2019s value, unless using a different alphabet; comply fully with the regulation by 20 June 2062; commemorative coins must: only have a face value of 2 euros; have a different national design from regular* 2-euro coins; only commemorate subjects of major national or European relevance or commemorate subjects of the highest European relevance if issued collectively throughout the euro area; euro area countries must inform each other and the Commission of any proposed changes to their national designs and submit this to an approval procedure. This allows for objections from a government that believes the design would upset its own public; the Commission, if it considers the design does not respect the legislation\u2019s technical requirements. FROM WHEN DO THE REGULATIONS APPLY? Regulation (EU) No 651/2012 has applied since 16 August 2012. Regulation (EU) No 729/2014 consolidates former rules regarding coins set when the euro was introduced in 2002 by the Regulation (EC) No 975/98 and successive amendments. It has applied since 22 July 2014. Both Regulations have integrated the elements of the Commission Recommendation 2009/23/EC on common guidelines for the national sides and the issuance of euro coins intended for circulation. BACKGROUND Euro coins came into general use in 2002. The eight denominations vary in size, colour and thickness depending on their value and are designed to make any illegal reproduction extremely difficult. For more information, see: \u2018Euro notes and coins\u2019 (European Commission). * KEY TERMS Circulation coins: coins for general public use which are legal tender in all euro area countries. Collector coins: coins not intended for circulation, which are legal tender only in the euro area country where they are issued. Commemorative coins: 2-euro circulation coins to commemorate a specific subject of national or European importance. Legal tender: coins or banknotes that must be accepted in a country if offered in payment of a debt. Regular coins: circulation coins excluding commemorative coins. MAIN DOCUMENTS Regulation (EU) No 651/2012 of the European Parliament and of the Council of 4 July 2012 on the issuance of euro coins (OJ L 201, 27.7.2012, pp. 135\u2013137) Council Regulation (EU) No 729/2014 of 24 June 2014 on denominations and technical specifications of euro coins intended for circulation (Recast) (OJ L 194, 2.7.2014, pp. 1\u20137) last update 04.04.2017"}
{"article": "20.12.2013 EN Official Journal of the European Union L 347/470 REGULATION (EU) No 1304/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2013 on the European Social Fund and repealing Council Regulation (EC) No 1081/2006 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 164 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinions of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure, Whereas: (1) Regulation (EU) No 1303/2013 of the European Parliament and of the Council (3) establishes the framework for action by the European Social Fund (ESF), the European Regional Development Fund (ERDF), the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and lays down, in particular, the thematic objectives, the principles and the rules concerning programming, monitoring and evaluation, management and control. It is therefore necessary to specify the mission and scope of the ESF, together with the related investment priorities addressing the thematic objectives, and to lay down specific provisions concerning the type of activities that may be financed by the ESF. (2) The ESF should improve employment opportunities, strengthen social inclusion, fight poverty, promote education, skills and life-long learning and develop active, comprehensive and sustainable inclusion policies in accordance with the tasks entrusted to the ESF by Article 162 of the Treaty on the Functioning of the European Union (TFEU), and thereby contribute to economic, social and territorial cohesion in accordance with Article 174 TFEU. In accordance with Article 9 TFEU, the ESF should take into account requirements linked to the promotion of a high level of employment, the guarantee of adequate social protection, the fight against social exclusion, and a high level of education, training and protection of human health. (3) The European Council of 17 June 2010 called for all common policies, including cohesion policy, to support the Europe 2020 Strategy for smart, sustainable and inclusive growth (the 'Europe 2020 strategy'). In order to ensure the full alignment of the ESF with the objectives of this strategy, particularly as regards employment, education, training and the fight against social exclusion, poverty and discrimination, the ESF should support Member States, taking account of the relevant Integrated Guidelines and relevant country-specific recommendations adopted in accordance with Article 121(2) and Article 148(4) TFEU and, where appropriate, at national level, the national reform programmes underpinned by national employment strategies, national social reports, national Roma integration strategies and national disability strategies. The ESF should also contribute to relevant aspects of the implementation of the flagship initiatives, in particular the \"Agenda for New Skills and Jobs\", the \"Youth on the Move\", and the \"European Platform against Poverty and Social Exclusion\". It should also support relevant activities in the initiatives on the \"Digital Agenda\" and \"Innovation Union\". (4) The Union is confronted with structural challenges arising from economic globalisation, technological change and an increasingly ageing workforce and growing skills and labour shortages in some sectors and regions. They have been compounded by the recent economic and financial crisis, which has resulted in increased levels of unemployment, hitting in particular young people and other disadvantaged people, such as migrants and minorities. (5) The ESF should aim to promote employment, improve access to the labour market, paying particular attention to those who are furthest from the labour market and support voluntary labour mobility. The ESF should also support active and healthy ageing, including through innovative forms of work organisation, promoting health and safety at work and increasing employability. In promoting the better functioning of labour markets by enhancing the transnational geographical mobility of workers, the ESF should, in particular, support EURES activities (activities of the European network of employment services) in relation to recruitment and related information, advice and guidance services at national and cross-border level. Operations financed by the ESF should comply with Article 5(2) of the Charter of Fundamental Rights of the European Union which provides that no one shall be required to perform forced or compulsory labour. (6) The ESF should also promote social inclusion and prevent and combat poverty with a view to breaking the cycle of disadvantage across generations which implies mobilising a range of policies targeting the most disadvantaged people regardless of their age including children, the working poor and older women. Attention should be paid to the participation of those seeking asylum and refugees. The ESF may be used to enhance access to affordable, sustainable and high quality services of general interest, in particular in the fields of health care, employment and training services, services for the homeless, out of school care, childcare and long-term care services. Services supported can be public, private and/or community-based, and delivered by different types of providers, namely public administrations, private companies, social enterprises, non-governmental organisations. (7) The ESF should undertake to tackle early school leaving, promote equal access to good quality education, invest in vocational education and training, improve the labour market relevance of education and training systems and enhance life-long learning, including formal, non-formal and informal learning pathways. (8) In addition to these priorities, in the less developed regions and Member States, and with a view to increasing economic growth and employment opportunities, the efficiency of public administration at national and regional level, as well as the ability of a public administration to act in a participative manner, should be improved. The institutional capacity of stakeholders, including non-governmental organisations, delivering employment, education, training and social policies, including in the field of anti-discrimination, should be strengthened. (9) Support under the investment priority \"community-led local development\" may contribute to all thematic objectives as set out in this Regulation. Community-led local development strategies supported by the ESF should be inclusive with regard to disadvantaged people present on the territory, both in terms of governance of local action groups and in terms of content of the strategy. (10) At the same time, it is crucial to support the development and competitiveness of micro, small and medium-sized enterprises of the Union and to ensure that people can adapt, through acquiring appropriate skills and through lifelong learning opportunities, to new challenges such as the shift to a knowledge-based economy, the digital agenda, and the transition to a low-carbon and more energy-efficient economy. By pursuing its primary thematic objectives, the ESF should contribute to addressing these challenges. In this context, the ESF should support the labour force transition from education to employment, towards greener skills and jobs, and should address skills shortages, including those in the energy-efficiency, renewable energy and sustainable transport sectors. The ESF should also contribute to cultural and creative skills. Socio-cultural, creative and cultural sectors are important in indirectly addressing the aims of the ESF; their potential should therefore be better integrated into ESF projects and programming. (11) In light of the persistent need to make an effort to address youth unemployment in the Union as a whole, a Youth Employment Initiative (YEI) should be created for the most affected regions. The YEI should support, in such regions, young persons not in employment, education or training (NEET), who are unemployed or inactive, thereby reinforcing and accelerating the delivery of activities supported by ESF funding. Additional funds should be specifically attributed to the YEI and should be matched with funding from the ESF in the most affected regions. By targeting individual persons rather than structures, the YEI should aim to complement other ESF\u2013funded operations and national actions targeting NEET, including through the implementation of the Youth Guarantee in line with the Council's Recommendation of 22 April 2013 on Establishing a Youth Guarantee (4), which provides that young persons should receive a good-quality offer of either employment, continued education, an apprenticeship or a traineeship within a period of four months of becoming unemployed or of leaving formal education. The YEI may also support actions to combat early school leaving. Access to welfare benefits for the young person and his/her family or dependants should not be conditional upon the young person's participation in the YEI. (12) The YEI should be fully integrated into ESF programming but, where appropriate, specific provisions related to YEI should be envisaged with a view to achieving its objectives. It is necessary to simplify and facilitate implementation of the YEI, in particular with regard to financial management provisions and thematic concentration arrangements. In order to ensure that the results of the YEI are clearly demonstrated and communicated, specific monitoring and evaluation, as well as information and publicity arrangements should be envisaged. Youth organisations should be involved in the monitoring committees' discussions on the preparation and implementation, including evaluation, of the YEI. (13) The ESF should contribute to the Europe 2020 strategy, ensuring a greater concentration of support on the priorities of the Union. A minimum share of cohesion policy funding for the ESF is established in accordance with Article 92(4) of Regulation (EU) No 1303/2013. The ESF should in particular increase its support for the fight against social exclusion and poverty, through a minimum ring-fenced allocation of 20 % of the total ESF resources of each Member State. The choice and number of investment priorities for ESF support should also be limited, in accordance with the level of development of the supported regions. (14) In order to ensure closer monitoring and improved assessment of the results achieved at the Union level by actions supported by the ESF, a common set of output and result indicators should be established in this Regulation. Such indicators should correspond to the investment priority and type of action supported in accordance with this Regulation as well as the relevant provisions of Regulation (EU) No 1303/2013. The indicators should be complemented where necessary by programme-specific result and/or output indicators. (15) Member States are encouraged to report on the effect of ESF investments on equal opportunities, equal access and integration of marginalised groups in all operational programmes. (16) Taking into account data protection requirements linked to collecting and storing sensitive data on participants, the Member States and the Commission should regularly evaluate the effectiveness, efficiency and impact of ESF support in promoting social inclusion and combating poverty, in particular with regard to disadvantaged people such as the Roma. Member States are encouraged to report on ESF-funded initiatives in the national social reports annexed to their national reform programmes, in particular as regards marginalised communities, such as the Roma and migrants. (17) Efficient and effective implementation of actions supported by the ESF depends on good governance and partnership between all relevant territorial and socio-economic actors, taking into account the actors at regional and local levels, in particular the umbrella associations representing local and regional authorities, organised civil society, economic and, in particular, social partners and non-governmental organisations. Member States should therefore ensure the participation of social partners and non-governmental organisations in the strategic governance of the ESF, from shaping priorities for operational programmes to implementing and evaluating ESF results. (18) The Member States and the Commission should ensure that the implementation of the priorities financed by the ESF contributes to the promotion of equality between women and men in accordance with Article 8 TFEU. Evaluations have shown the importance of taking the gender equality objectives aspect into account in all dimensions and in all stages of the preparation, monitoring, implementation and evaluation of operational programmes, in a timely and consistent manner while ensuring that specific actions are taken to promote gender equality, the economic independence of women, education and skills upgrading and the reintegration of female victims of violence into the labour market and into society. (19) In accordance with Article 10 TFEU, the implementation of the priorities financed by the ESF should contribute to combating discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation by paying particular attention to those facing multiple discrimination. Discrimination on the ground of sex should be interpreted in a broad sense so as to cover other gender-related aspects in line with the case law of the Court of Justice of the European Union. The implementation of the priorities financed by the ESF should also contribute to promoting equal opportunities. The ESF should support the fulfilment of the Union's obligation under the UN Convention on the Rights of Persons with Disabilities with regard inter alia to education, work, employment and accessibility. The ESF should also promote the transition from institutional to community-based care. The ESF should not support any action that contributes to segregation or to social exclusion. (20) Support for social innovation contributes to making policies more responsive to social change. The ESF should encourage and support innovative social enterprises and entrepreneurs as well as innovative projects taken on by non-governmental organisations and other actors within the social economy. In particular, testing and evaluating innovative solutions before scaling them up is instrumental in improving the efficiency of policies and thus justifies specific support from the ESF. Innovative solutions could include, provided they prove to be effective, the development of social metrics such as, for example, social labelling. (21) Transnational cooperation has significant added value and should therefore be supported by all Member States with the exception of duly justified cases taking account of the principle of proportionality. It is also necessary to reinforce the Commission's role in facilitating exchanges of experience and coordinating implementation of relevant initiatives. (22) With a view to fostering an integrated and holistic approach in terms of employment and social inclusion, the ESF should support cross-sectoral and territorial-based partnerships. (23) The mobilisation of regional and local stakeholders should help to deliver the Europe 2020 strategy and its headline targets. Territorial pacts, local initiatives for employment and social inclusion, sustainable and inclusive community-led local development strategies in urban and rural areas and sustainable urban development strategies may be used and supported to involve more actively regional and local authorities, cities, social partners and non-governmental organisations throughout the preparation and implementation of operational programmes. (24) Regulation (EU) No 1303/2013 provides that rules on eligibility of expenditure are to be established at the national level, with certain exceptions for which it is necessary to lay down specific provisions with regard to the ESF. (25) With a view to simplifying the use of the ESF and reducing the risk of error, and with regard to the specificities of the operations supported by the ESF, it is appropriate to lay down provisions which complement Regulation (EU) No 1303/2013 as regards eligibility of expenditure. (26) The use of standard scales of unit costs, lump sums and flat-rate financing should lead to simplification for the beneficiary and should lower the administrative burden for all ESF project partners. (27) It is important to ensure the sound financial management of each operational programme and its implementation in the most effective and user-friendly manner possible. Member States should refrain from adding rules that complicate the use of funds for the beneficiary. (28) The Member States and the regions should be encouraged to leverage the ESF through financial instruments in order to support, for example, students, job creation, the mobility of workers, social inclusion and social entrepreneurship. (29) The ESF should complement other Union programmes and close synergies should be developed between the ESF and other Union financial instruments. (30) Investment in human capital is the main force on which the Union can rely to ensure its international competitiveness and the sustainable recovery of its economy. No type of investment can produce structural reforms unless it is accompanied by a coherent, growth-oriented human capital development strategy. It is therefore necessary to ensure that in the 2014-2020 programming period the resources intended to improve skills and raise employment levels allow action to be taken on an adequate scale. (31) The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission for establishing the definition of standard scales of unit costs and lump sums and their maximum amounts according to different types of operations. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure the simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (32) The Commission should be assisted in the administration of the ESF by the Committee provided for in Article 163 TFEU. (33) Since this Regulation replaces Regulation (EC) No 1081/2006 of the European Parliament and of the Council (5), that Regulation should be repealed. Nevertheless, this Regulation should not affect either the continuation or modification of assistance approved by the Commission on the basis of Regulation (EC) No 1081/2006 or any other legislation applying to that assistance on 31 December 2013. That Regulation or such other applicable legislation should consequently continue to apply after 31 December 2013 to that assistance or the operations concerned until their closure. Applications to receive assistance made or approved under Regulation (EC) No 1081/2006 should remain valid, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the missions of the European Social Fund (ESF), including the Youth Employment Initiative (YEI), the scope of its support, specific provisions and the types of expenditure eligible for assistance. Article 2 Missions 1. The ESF shall promote high levels of employment and job quality, improve access to the labour market, support the geographical and occupational mobility of workers and facilitate their adaptation to industrial change and to changes in production systems needed for sustainable developments, encourage a high level of education and training for all and support the transition between education and employment for young people, combat poverty, enhance social inclusion, and promote gender equality, non-discrimination and equal opportunities, thereby contributing to the priorities of the Union as regards strengthening economic, social and territorial cohesion. 2. The ESF shall fulfil the missions set out in paragraph 1 by supporting Member States in pursuing the priorities and headline targets of the Union strategy for smart, sustainable and inclusive growth (the 'Europe 2020 strategy') and by allowing Member States to address their specific challenges with regard to achieving the Europe 2020 strategy objectives. The ESF shall support the design and implementation of policies and actions in connection with its missions, taking account of the relevant Integrated Guidelines and relevant country-specific recommendations adopted in accordance with Article 121(2) and Article 148(4) TFEU and, where appropriate, at national level, the national reform programmes as well as other relevant national strategies and reports. 3. The ESF shall benefit people, including disadvantaged people such as the long-term unemployed, people with disabilities, migrants, ethnic minorities, marginalised communities and people of all ages facing poverty and social exclusion. The ESF shall also provide support to workers, enterprises, including actors in the social economy, and entrepreneurs, as well as to systems and structures with a view to facilitating their adaptation to new challenges including reducing skill mismatches and promoting good governance, social progress, and the implementation of reforms, in particular in the fields of employment, education, training and social policies. Article 3 Scope of support 1. Under the thematic objectives set out in points (8), (9), (10) and (11) of the first paragraph of Article 9 of Regulation (EU) No 1303/2013, which correspond to points (a), (b), (c) and (d) of this paragraph, and in accordance with its missions, the ESF shall support the following investment priorities: (a) For the thematic objective 'promoting sustainable and quality employment and supporting labour mobility': (i) Access to employment for job-seekers and inactive people, including the long-term unemployed and people far from the labour market, also through local employment initiatives and support for labour mobility; (ii) Sustainable integration into the labour market of young people, in particular those not in employment, education or training, including young people at risk of social exclusion and young people from marginalised communities, including through the implementation of the Youth Guarantee; (iii) Self-employment, entrepreneurship and business creation including innovative micro, small and medium sized enterprises; (iv) Equality between men and women in all areas, including in access to employment, career progression, reconciliation of work and private life and promotion of equal pay for equal work; (v) Adaptation of workers, enterprises and entrepreneurs to change; (vi) Active and healthy ageing; (vii) Modernisation of labour market institutions, such as public and private employment services, and improving the matching of labour market needs, including through actions that enhance transnational labour mobility as well as through mobility schemes and better cooperation between institutions and relevant stakeholders; (b) For the thematic objective 'promoting social inclusion, combating poverty and any discrimination': (i) Active inclusion, including with a view to promoting equal opportunities and active participation, and improving employability; (ii) Socio-economic integration of marginalised communities such as the Roma; (iii) Combating all forms of discrimination and promoting equal opportunities; (iv) Enhancing access to affordable, sustainable and high-quality services, including health care and social services of general interest; (v) Promoting social entrepreneurship and vocational integration in social enterprises and the social and solidarity economy in order to facilitate access to employment; (vi) Community-led local development strategies; (c) For the thematic objective 'investing in education, training and vocational training for skills and life-long learning': (i) Reducing and preventing early school-leaving and promoting equal access to good quality early-childhood, primary and secondary education including formal, non-formal and informal learning pathways for reintegrating into education and training; (ii) Improving the quality and efficiency of, and access to, tertiary and equivalent education with a view to increasing participation and attainment levels, especially for disadvantaged groups; (iii) Enhancing equal access to lifelong learning for all age groups in formal, non-formal and informal settings, upgrading the knowledge, skills and competences of the workforce, and promoting flexible learning pathways including through career guidance and validation of acquired competences; (iv) Improving the labour market relevance of education and training systems, facilitating the transition from education to work, and strengthening vocational education and training systems and their quality, including through mechanisms for skills anticipation, adaptation of curricula and the establishment and development of work-based learning systems, including dual learning systems and apprenticeship schemes; (d) For the thematic objective 'enhancing institutional capacity of public authorities and stakeholders and efficient public administration': (i) Investment in institutional capacity and in the efficiency of public administrations and public services at the national, regional and local levels with a view to reforms, better regulation and good governance; This investment priority is applicable only in Member States eligible for support from the Cohesion Fund, or in Member States that have one or more NUTS level 2 regions referred to in Article 90(2)(a) of Regulation (EU) No 1303/2013. (ii) Capacity building for all stakeholders delivering education, lifelong learning, training and employment and social policies, including through sectoral and territorial pacts to mobilise for reform at the national, regional and local levels. 2. Through the investment priorities listed in paragraph 1, the ESF shall also contribute to the other thematic objectives listed in the first paragraph of Article 9 of Regulation (EU) No 1303/2013, primarily by: (a) Supporting the shift towards a low-carbon, climate-resilient, resource-efficient and environmentally sustainable economy, through the improvement of education and training systems necessary for the adaptation of skills and qualifications, the up-skilling of the labour force, and the creation of new jobs in sectors related to the environment and energy; (b) Enhancing the accessibility of, and use and quality of, information and communication technologies through the development of digital literacy and e-learning, and investment in e-inclusion, e-skills and related entrepreneurial skills; (c) Strengthening research, technological development and innovation through the development of post-graduate studies and entrepreneurial skills, the training of researchers, networking activities and partnerships between higher education institutions, research and technological centres and enterprises; (d) Enhancing the competitiveness and long-term sustainability of small and medium-sized enterprises, through promoting the adaptability of enterprises, managers and workers, increased investment in human capital, and support for bodies providing practice-oriented vocational education and training. Article 4 Consistency and thematic concentration 1. Member States shall ensure that the strategy and actions set out in their operational programmes are consistent with, and respond to, the challenges identified in their national reform programmes, as well as, where relevant, in their other national strategies that aim to fight unemployment, poverty and social exclusion, and also in the relevant Council recommendations adopted in accordance with Article 148(4) TFEU, in order to contribute to achieving the headline targets of the Europe 2020 strategy on employment, education and poverty reduction. 2. At least 20 % of the total ESF resources in each Member State shall be allocated to the thematic objective \"promoting social inclusion, combating poverty and any discrimination\" set out in point (9) of the first paragraph of Article 9 of Regulation (EU) No 1303/2013. 3. Member States shall pursue thematic concentration according to the following modalities: (a) For more developed regions, Member States shall concentrate at least 80 % of the ESF allocation to each operational programme on up to five of the investment priorities set out in Article 3(1). (b) For transition regions, Member States shall concentrate at least 70 % of the ESF allocation to each operational programme on up to five of the investment priorities set out in Article 3(1). (c) For less developed regions, Member States shall concentrate at least 60 % of the ESF allocation to each operational programme on up to five of the investment priorities set out in Article 3(1). 4. The priority axes referred to in Article 11(1) shall be excluded from the calculation of the percentages specified in paragraphs 2 and 3 of this Article. Article 5 Indicators 1. Common output and result indicators, as set out in Annex I to this Regulation, and, where relevant, programme-specific indicators shall be used in accordance with Article 27(4) and Article 96(2)(b)(ii) and (iv) of Regulation (EU) No 1303/2013. All common output and result indicators shall be reported for all investment priorities. The result indicators set out in Annex II to this Regulation shall be reported in accordance with paragraph 2 of this Article. Where applicable, data shall be broken down by gender. For common and programme-specific output indicators, baselines shall be set at zero. Where relevant to the nature of the operations supported, cumulative quantified target values for those indicators shall be set for 2023. Output indicators shall be expressed in absolute numbers. For those common and programme-specific result indicators for which a cumulative quantified target value for 2023 has been set, baselines shall be fixed using the latest available data or other relevant sources of information. Programme-specific result indicators and related targets may be expressed in quantitative or qualitative terms. 2. In addition to paragraph 1, result indicators set out in Annex II to this Regulation shall be used for all operations supported under the investment priority referred to in Article 3(1)(a)(ii) for the implementation of the YEI. All indicators set out in Annex II to this Regulation shall be linked with a quantified cumulative target value for 2023 and a baseline. 3. Together with annual implementation reports, each managing authority shall transmit electronically structured data for each priority axis broken down by investment priority. The data shall be submitted for the categories of intervention referred to in Article 96(2)(b)(vi) of Regulation (EU) No 1303/2013and the output and result indicators. By way of derogation from Article 50(2) of Regulation (EU) No 1303/2013, data transmitted for output and result indicators shall relate to values for partially or fully implemented operations. CHAPTER II SPECIFIC PROVISIONS FOR PROGRAMMING AND IMPLEMENTATION Article 6 Involvement of partners 1. The participation of the partners referred to in Article 5 of Regulation (EU) No 1303/2013 in the implementation of the operational programmes may take the form of global grants as defined in Article 123(7) of Regulation (EU) No 1303/2013. In such cases, the operational programme shall identify the part of the operational programme concerned by the global grant, including an indicative financial allocation from each priority axis to it. 2. To encourage adequate participation of the social partners in actions supported by the ESF, the managing authorities of an operational programme in a region defined in Article 90(2)(a) or (b) of Regulation (EU) No 1303/2013 or in a Member State eligible for support from the Cohesion Fund shall ensure that, according to the needs, an appropriate amount of ESF resources is allocated to capacity building activities, in the form of training, networking measures, and strengthening of the social dialogue, and to activities jointly undertaken by the social partners. 3. To encourage the adequate participation of, and access by, non-governmental organisations in and to actions supported by the ESF, in particular in the fields of social inclusion, gender equality and equal opportunities, the managing authorities of an operational programme in a region defined in Article 90(2)(a) or (b) of Regulation (EU) No 1303/2013 or in a Member State eligible for support from the Cohesion Fund shall ensure that an appropriate amount of ESF resources is allocated to capacity building for non-governmental organisations. Article 7 Promotion of equality between men and women The Member States and the Commission shall promote equality between men and women through mainstreaming as referred to in Article 7 of Regulation (EU) No 1303/2013 throughout the preparation, implementation, monitoring and evaluation of the operational programmes. Through the ESF, the Member States and the Commission shall also support specific targeted actions within any of the investment priorities referred to in Article 3, and in particular Article 3(1)(a)(iv) of this Regulation, with the aim of increasing the sustainable participation and progress of women in employment, thus combating the feminisation of poverty, reducing gender-based segregation, combating gender stereotypes in the labour market and in education and training, and promoting the reconciliation of work and personal life for all as well as the equal sharing of care responsibilities between men and women. Article 8 Promotion of equal opportunities and non-discrimination The Member States and the Commission shall promote equal opportunities for all, without discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation through mainstreaming the principle of non-discrimination, as referred to in Article 7 of Regulation (EU) No 1303/2013. Through the ESF, the Member States and the Commission shall also support specific actions within any of the investment priorities referred to in Article 3, and in particular Article 3(1)(b)(iii) of this Regulation. Such actions shall aim to combat all forms of discrimination as well as to improve accessibility for persons with disabilities, with a view to improving integration into employment, education and training, thereby enhancing social inclusion, reducing inequalities in terms of educational attainment and health status, and facilitating the transition from institutional to community-based care, in particular for those who face multiple discrimination. Article 9 Social innovation 1. The ESF shall promote social innovation within all areas falling under its scope, as defined in Article 3 of this Regulation, in particular with the aim of testing, evaluating and scaling up innovative solutions, including at the local or regional level, in order to address social needs in partnership with the relevant partners and, in particular, social partners. 2. Member States shall identify, either in their operational programmes or at a later stage during implementation, fields for social innovation that correspond to the Member States' specific needs. 3. The Commission shall facilitate capacity building for social innovation, in particular through supporting mutual learning, establishing networks, and disseminating and promoting good practices and methodologies. Article 10 Transnational cooperation 1. Member States shall support transnational cooperation with the aim of promoting mutual learning, thereby increasing the effectiveness of policies supported by the ESF. Transnational cooperation shall involve partners from at least two Member States. 2. By way of derogation from paragraph 1, Member States with a single operational programme supported by the ESF or a single multi-fund operational programme may exceptionally choose not to support transnational cooperation actions, in duly justified cases and taking account of the principle of proportionality. 3. Member States, in partnership with the relevant partners, may select themes for transnational cooperation from a list of common themes proposed by the Commission and endorsed by the Committee referred to in Article 25 or select any other themes corresponding to their specific needs. 4. The Commission shall facilitate transnational cooperation on the common themes of the list referred to in paragraph 3 and, where appropriate, other themes selected by Member States, through mutual learning and coordinated or joint action. In particular, the Commission shall operate an EU-level platform to facilitate the setting up of transnational partnerships, the exchange of experiences, capacity building and networking, and the capitalisation on and the dissemination of the relevant outcomes. In addition, the Commission shall develop a coordinated implementation framework, including common eligibility criteria, types and timing of actions, and common methodological approaches for monitoring and evaluation, with a view to facilitating transnational cooperation. Article 11 Fund-specific provisions for operational programmes 1. By way of derogation from Article 96(1) of Regulation (EU) No 1303/2013, operational programmes may set out priority axes for the implementation of social innovation and transnational cooperation as referred to in Articles 9 and 10 of this Regulation. 2. By way of derogation from Article 120(3) of Regulation (EU) No 1303/2013, the maximum co-financing rate for a priority axis shall be increased by ten percentage points, but shall not exceed 100 % where the whole of a priority axis is dedicated to social innovation or to transnational cooperation, or a combination of both. 3. In addition to the provision made in Article 96(3) of Regulation (EU) No 1303/2013, operational programmes shall also set out the contribution of planned ESF-supported actions to: (a) the thematic objectives listed under points (1) to (7) of the first paragraph of Article 9 of Regulation (EU) No 1303/2013 by priority axis, as appropriate; (b) social innovation and transnational cooperation, as referred to in Articles 9 and 10 of this Regulation, where they are not covered by a dedicated priority axis. Article 12 Specific provisions on the treatment of particular territorial features 1. The ESF may support community-led local development strategies in urban and rural areas, as referred to in Articles 32, 33 and 34 of Regulation (EU) No 1303/2013, territorial pacts and local initiatives for employment, including youth employment, education and social inclusion, as well as Integrated territorial investments (ITI) as referred to in Article 36 of Regulation (EU) No 1303/2013. 2. As a complement to ERDF interventions as referred to in Article 7 of Regulation (EU) No 1301/2013 of the European Parliament and of the Council (6), the ESF may support sustainable urban development through strategies setting out integrated actions to tackle the economic, environmental and social challenges affecting the urban areas identified by the Member States on the basis of the principles laid down in their respective Partnership Agreements. CHAPTER III SPECIFIC PROVISIONS FOR FINANCIAL MANAGEMENT Article 13 Eligibility of expenditure 1. The ESF shall provide support for eligible expenditure which, as referred to in Article 120(2)(b) of Regulation (EU) No 1303/2013, may include any financial resources collectively contributed by employers and workers. 2. The ESF may provide support for expenditure incurred for operations which take place outside the programme area, but within the Union, provided that the following two conditions are satisfied: (a) the operation is for the benefit of the programme area; (b) the obligations of the authorities for the operational programme in relation to management, control and audit concerning the operation are fulfilled by the authorities responsible for the operational programme under which that operation is supported or they enter into agreements with authorities in the Member State in which the operation is implemented provided that in that Member State the obligations in relation to management, control and audit concerning the operation are met. 3. Up to a limit of 3 % of the budget of an ESF operational programme or the ESF part of a multi-fund operational programme, expenditure incurred outside the Union shall be eligible for a contribution from the ESF provided that it concerns the thematic objectives under Article 3(1)(a) or Article 3(1)(c) and provided that the relevant monitoring committee has given its agreement to the operation or types of operations concerned. 4. In addition to the expenditure referred to in Article 69(3) of Regulation (EU) No 1303/2013, the purchase of infrastructure, land and real estate shall also not be eligible for a contribution from the ESF. 5. Contributions in kind in the form of allowances or salaries disbursed by a third party for the benefit of the participants in an operation may be eligible for a contribution from the ESF provided that the contributions in kind are incurred in accordance with national rules, including accountancy rules, and do not exceed the cost borne by the third party. Article 14 Simplified cost options 1. In addition to the options referred to in Article 67 of Regulation (EU) No 1303/2013, the Commission may reimburse expenditure paid by Member States on the basis of standard scales of unit costs and lump sums defined by the Commission. The amounts calculated on this basis shall be regarded as public support paid to beneficiaries and as eligible expenditure for the purpose of applying Regulation (EU) No 1303/2013. For the purpose of the first subparagraph, the Commission shall be empowered to adopt delegated acts in accordance with Article 24 concerning the type of operations covered, the definitions of the standard scales of unit costs and lump sums and their maximum amounts, which may be adjusted according to the applicable commonly agreed methods, taking due account of experience gained during the previous programming period. Financial audit shall exclusively aim at verifying that the conditions for reimbursement by the Commission on the basis of standard scales of unit costs and lump sums have been fulfilled. Where funding on the basis of standard scales of unit costs and lump sums, in accordance with the first subparagraph, is used, the Member State may apply its accounting practices to support operations. For the purpose of this Regulation and Regulation (EU) No 1303/2013, such accounting practices and the resulting amounts shall not be subject to audit by the audit authority or by the Commission. 2. In accordance with Article 67(1)(d) and (5)(d) of Regulation (EU) No 1303/2013, a flat rate of up to 40 % of the eligible direct staff costs may be used in order to cover the remaining eligible costs of an operation without a requirement for the Member State to execute any calculation to determine the applicable rate. 3. In addition to the methods stipulated in Article 67(5) of Regulation (EU) No 1303/2013, where the public support for grants and repayable assistance does not exceed EUR 100 000, the amounts referred to in Article 67(1)(b), (c) and (d) of Regulation (EU) No 1303/2013 may be established on a case-by-case basis by reference to a draft budget agreed ex ante by the managing authority. 4. Without prejudice to Article 67 (4) of Regulation (EU) No (1303/2013), grants and repayable assistance for which the public support does not exceed EUR 50 000 shall take the form of standard scales of unit costs or lump sums in accordance with paragraph 1 of this Article or with Article 67 of Regulation (EU) No (1303/2013) or flat rates in accordance with Article 67 of Regulation (EU) No (1303/2013), except for operations receiving support within the framework of a State aid scheme. Where flat-rate financing is used, the categories of costs which are used to calculate the rate may be reimbursed in accordance with Article 67(1)(a) of Regulation (EU) No (1303/2013). Article 15 Financial instruments Pursuant to Article 37 of Regulation (EU) No 1303/2013, the ESF may support actions and policies falling within its scope through financial instruments, including micro-credits and guarantee funds. CHAPTER IV YOUTH EMPLOYMENT INITIATIVE Article 16 Youth Employment Initiative The YEI shall support the fight against youth unemployment in eligible regions of the Union through providing support to actions under Article 3(1)(a)(ii) of this Regulation. It shall target all young persons under the age of 25 not in employment, education or training, residing in eligible regions, who are inactive or unemployed including the long-term unemployed, and whether or not registered as seeking work. On a voluntary basis, Member States may decide to extend the target group to include young persons under the age of 30. For the purpose of the YEI for 2014-2015, \"eligible regions\" are those NUTS level 2 regions that have youth unemployment rates for young persons aged 15 to 24 of more than 25 % in 2012 and, for Member States where the youth unemployment rate has increased by more than 30 % in 2012, NUTS level 2 regions that have youth unemployment rates of more than 20 % in 2012. The resources for the YEI may be revised upwards for the years 2016 to 2020 in the framework of the budgetary procedure in accordance with Article 14 of Regulation (EU) 1311/2013. For the determination of the regions eligible for the YEI for the period 2016-2020, the reference to 2012 data in the second subparagraph shall be construed as a reference to the latest available annual data. The breakdown by Member State of the additional resources shall follow the same steps as the initial allocation in accordance with Annex VIII of Regulation (EU) No 1303/2013. In agreement with the Commission, Member States may decide to allocate a limited amount not exceeding 10 % of the funds under the YEI to young persons residing in sub-regions which experience high youth unemployment levels and which are outside the eligible NUTS level 2 regions. Article 17 Thematic concentration The specific allocation for YEI shall not be taken into account for the purpose of calculating the thematic concentration referred to in Article 4. Article 18 Programming The YEI is integrated into the programming of the ESF under Article 96 of Regulation (EU) No 1303/2013. Where appropriate, Member States shall set out the programming arrangements for the YEI in their Partnership Agreements and in their operational programmes. The programming arrangements may take one or more of the following forms: (a) a dedicated operational programme; (b) a dedicated priority axis within an operational programme; (c) a part of one or more priority axes. Article 9 and 10 of this Regulation shall also apply to the YEI. Article 19 Monitoring and evaluation 1. In addition to the functions of the monitoring committee set out in Article 110 of Regulation (EU) No 1303/2013, at least once per year, the monitoring committee shall examine the implementation of the YEI in the context of the operational programme and the progress made towards achieving its objectives. 2. The annual implementation reports and the final report as referred to in Article 50(1) and (2) of Regulation (EU) No 1303/2013 shall include additional information on the implementation of the YEI. The Commission shall transmit to the European Parliament a summary of those reports as referred to in Article 53(1) of Regulation (EU) No 1303/2013. The Commission shall attend the European Parliament's annual debate on those reports. 3. As from April 2015 and for subsequent years, and at the same time as the annual implementation reports referred to in Article 50(1) and (2) of Regulation (EU) No 1303/2013, the managing authority shall transmit electronically to the Commission structured data for each priority axis or any part thereof supporting the YEI. Indicator data transmitted shall relate to values for the indicators set out in Annexes I and II to this Regulation and, where applicable, to programme specific indicators. They shall relate to partially or fully implemented operations. 4. The annual implementation reports referred to in Article 50(4) of Regulation (EU) No 1303/2013 or, where applicable, the progress report referred to in Article 111(4) of Regulation (EU) No 1303/2013. and the annual implementation report submitted by 31 May 2016, shall present the main findings of evaluations referred to in paragraph 6 of this Article. The reports shall also set out and assess the quality of employment offers received by YEI participants, including disadvantaged persons, those from marginalised communities and those leaving education without qualifications. The reports shall also set out and assess their progress in continuing education, finding sustainable and decent jobs, or moving into apprenticeships or quality traineeships. 5. The progress reports referred to in Article 52 of Regulation (EU) No 1303/2013 shall include additional information on, and assess the implementation of, the YEI. The Commission shall transmit to the European Parliament a summary of these reports as referred to in Article 53(2) of that Regulation and shall attend the European Parliament's debate on those reports. 6. At least twice during the programming period, an evaluation shall assess the effectiveness, efficiency and impact of joint support from the ESF and the specific allocation for YEI including for the implementation of the Youth Guarantee. The first evaluation shall be completed by 31 December 2015 and the second evaluation by 31 December 2018. Article 20 Information and communication measures 1. The beneficiaries shall ensure that those taking part in an operation are specifically informed of the YEI support provided through the ESF funding and the specific YEI allocation. 2. Any document relating to the implementation of an operation and issued for the public or for participants, including an attendance or other certificate, shall include a statement to the effect that the operation was supported under the YEI. Article 21 Technical assistance The specific allocation for YEI may be taken into account by the Member States in the calculation of the limit on the total amount of funds allocated to technical assistance for each Member State. Article 22 Financial support 1. The Commission decision adopting an operational programme shall fix the maximum amount of support from the specific allocation for YEI and the corresponding ESF support, as a global amount and also by category of regions, for each priority axis. The corresponding ESF support shall at least match the support from the specific allocation for YEI for each priority axis. 2. On the basis of the amounts referred to in paragraph 1, the Commission decision referred to in paragraph 1 shall also fix the ratio between the categories of regions for the ESF support for each priority axis. 3. Where the YEI is implemented by a specific priority axis covering eligible regions from more than one category, the highest co-financing rate shall apply with regard to the ESF allocation. The specific allocation for YEI shall not be subject to the national co-financing requirement. The overall co-financing rate of the priority axis fixed by the Commission decision referred to in paragraph 1 shall be calculated taking into account the co-financing rate of the ESF allocation together with the special allocation for the YEI. Article 23 Financial management In addition to Article 130 of Regulation (EU) No 1303/2013, when the Commission reimburses interim payments and pays the final balance for the YEI by priority axis, it shall allocate the reimbursement from the budget of the Union equally between the ESF and the specific allocation for YEI. Once all resources from the specific allocation for YEI have been reimbursed, the Commission shall allocate the remaining reimbursements from the budget of the Union to the ESF. The Commission shall allocate the reimbursement from the ESF between categories of regions according to the ratio laid down in Article 22 (2). CHAPTER V DELEGATIONS OF POWER AND FINAL PROVISIONS Article 24 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 14(1) shall be conferred on the Commission from21 December 2013 until 31 December 2020. 3. The delegation of power referred to in Article 14(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 14(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council, or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 25 Committee under Article 163 TFEU 1. The Commission shall be assisted by a Committee (the \"ESF Committee\") set up under Article 163 TFEU. 2. The member of the Commission responsible for chairing the ESF Committee may delegate that responsibility to a senior Commission official. The Secretariat of the ESF Committee shall be provided by the Commission. 3. Each Member State shall appoint one government representative, one representative of the workers' organisations, one representative of the employers' organisations and one alternate for each member for a maximum period of seven years. In the absence of a member, the alternate shall be automatically entitled to take part in the proceedings. 4. The ESF Committee shall include one representative from each of the organisations representing workers' organisations and employers' organisations at Union level. 5. The ESF Committee may invite non-voting representatives of the European Investment Bank and the European Investment Fund as well as non-voting representatives of the relevant civil society organizations to its meetings, if the agenda of the meeting requires their participation. 6. The ESF Committee shall: (a) be consulted on draft Commission decisions relating to operational programmes and programming in the case of support from the ESF; (b) be consulted on the planned use of technical assistance in the case of support from the ESF, as well as on other issues having an impact on the implementation of strategies at Union level relevant to the ESF; (c) endorse the list of common themes for transnational cooperation provided for in Article 10(3). 7. The ESF Committee may deliver opinions on: (a) questions related to the ESF contribution to the implementation of the Europe 2020 strategy; (b) issues concerning Regulation (EU) No 1303/2013 relevant for the ESF; (c) questions related to the ESF referred to it by the Commission other than those referred to in paragraph 6. 8. The opinions of the ESF Committee shall be adopted by an absolute majority of the votes validly cast, and shall be communicated to the European Parliament for information. The Commission shall inform the ESF Committee of the manner in which it has taken account of its opinions. Article 26 Transitional provisions 1. This Regulation shall not affect either the continuation or modification, including the total or partial cancellation, of assistance approved by the Commission on the basis of Regulation (EC) No 1081/2006 or any other legislation applying to that assistance on 31 December 2013. That Regulation or such other applicable legislation shall consequently continue to apply after 31 December 2013 to that assistance or the operations concerned until their closure. 2. Applications to receive assistance made or approved under Regulation (EC) No 1081/2006 before 1 January 2014 shall remain valid. Article 27 Repeal Without prejudice to the provisions laid down in Article 26 of this Regulation, Regulation (EC) No 1081/2006 is hereby repealed with effect from 1 January 2014. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex III. Article 28 Review The European Parliament and the Council shall review this Regulation by 31 December 2020 in accordance with Article 164 TFEU. Article 29 Entry in force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 December 2013. For the European Parliament The President M. SCHULZ For the Council The President R. \u0160AD\u017dIUS (1) OJ C 143, 22.5.2012, p. 82 and OJ C 271, 19.9.2013, p. 101. (2) OJ C 225, 27.7.2012, p. 127. (3) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (See page 320 of this Official Journal). (4) OJ C 120, 26.4.2013, p. 1. (5) Regulation (EC) No 1081/2006 of the European Parliament and of the Council of 5 July 2006 on the European Social Fund and repealing Regulation (EC) No 1784/1999 (OJ L 210, 31.7.2006, p. 12). (6) Regulation (EU) No 1301/2013 of the European Parliament and of the Council of 17 December 2013 on the European Regional Development Fund and the Investment for growth and jobs goal and repealing Regulation (EC) No 1080/2006 (See page 289 of this Official Journal). ANNEX I Common output and result indicators for ESF investments (1) Common output indicators for participants \"Participants\" (1) refers to persons benefiting directly from an ESF intervention who can be identified and asked for their characteristics, and for whom specific expenditure is earmarked. Other persons shall not be classified as participants. All data shall be broken down by gender. The common output indicators for participants are: \u2014 unemployed, including long-term unemployed*, \u2014 long-term unemployed*, \u2014 inactive*, \u2014 inactive, not in education or training*, \u2014 employed, including self-employed*, \u2014 below 25 years of age*, \u2014 above 54 years of age*, \u2014 above 54 years of age who are unemployed, including long-term unemployed, or inactive not in education or training*, \u2014 with primary (ISCED 1) or lower secondary education (ISCED 2)*, \u2014 with upper secondary (ISCED 3) or post-secondary education (ISCED 4)*, \u2014 with tertiary education (ISCED 5 to 8)*, \u2014 participants who live in jobless households*, \u2014 participants who live in jobless households with dependent children*, \u2014 participants who live in a single adult household with dependent children*, \u2014 migrants, participants with a foreign background, minorities (including marginalised communities such as the Roma)**, \u2014 participants with disabilities**, \u2014 other disadvantaged**. The total number of participants will be calculated automatically on the basis of the output indicators. These data on participants entering an ESF supported operation shall be provided in the annual implementation reports as specified in Article 50(1) and (2) and Article 111(1) of Regulation (EU) No 1303/2013. \u2014 homeless or affected by housing exclusion*, \u2014 from rural areas* (2). The data on participants under the two above indicators will be provided in the annual implementation reports as specified in Article 50(4) of Regulation (EU) No 1303/2013. The data shall be collected based on a representative sample of participants within each investment priority. Internal validity of the sample shall be ensured in such a way that the data can be generalised at the level of investment priority. (2) Common output indicators for entities are: \u2014 number of projects fully or partially implemented by social partners or non-governmental organisations, \u2014 number of projects dedicated at sustainable participation and progress of women in employment, \u2014 number of projects targeting public administrations or public services at national, regional or local level, \u2014 number of supported micro, small and medium-sized enterprises (including cooperative enterprises, enterprises of the social economy). These data shall be provided in the annual implementation reports as specified in Article 50(1) and (2) and Article 111(1) of Regulation (EU) No 1303/2013. (3) Common immediate result indicators for participants are: \u2014 inactive participants engaged in job searching upon leaving*, \u2014 participants in education/training upon leaving*, \u2014 participants gaining a qualification upon leaving*, \u2014 participants in employment, including self-employment, upon leaving*, \u2014 disadvantaged participants engaged in job searching, education/ training, gaining a qualification, in employment, including self-employment, upon leaving**. These data shall be provided in the annual implementation reports as specified in Article 50(1) and (2) and Article 111(1) of Regulation (EU) No 1303/2013. All data shall be broken down by gender. (4) Common longer-term result indicators for participants are: \u2014 participants in employment, including self-employment, six months after leaving*, \u2014 participants with an improved labour market situation six months after leaving*, \u2014 participants above 54 years of age in employment, including self-employment, six months after leaving*, \u2014 disadvantaged participants in employment, including self-employment, six months after leaving**. These data shall be provided in the annual implementation reports as specified in Article 50(5) of Regulation (EU) No 1303/2013. They shall be collected based on a representative sample of participants within each investment priority. Internal validity of the sample shall be ensured in such a way that the data can be generalised at the level of investment priority. All data shall be broken down by gender. (1) Managing authorities shall establish a system that records and stores individual participant data in computerised form as set out in Article 125 (2) (d) of Regulation (EU) No 1303/2013. The data processing arrangements put in place by the Member States shall be in line with the provisions of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31), in particular Articles 7 and 8 thereof. Data reported under the indicators marked with * are personal data according to Article 7 of Directive 95/46/EC. Their processing is necessary for compliance with the legal obligation to which the controller is subject (Article 7(c) of Directive 95/46/EC). For the definition of controller, see Article 2 of Directive 95/46/EC. Data reported under the indicators marked with ** are a special category of data according to Article 8 of Directive 95/46/EC. Subject to the provision of suitable safeguards, Member States may, for reasons of substantial public interest, lay down exemptions in addition to those laid down in Article 8(2) of Directive 95/46/EC, either by national law or by decision of the supervisory authority (Article 8(4) of Directive 95/46/EC). (2) The data shall be collected at the level of smaller administrative units (local administrative units 2), in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1). ANNEX II Result indicators for the YEI These data shall be provided in the annual implementation reports as specified in Article 50(1) and (2) of Regulation (EU) No 1303/2013 and in the report to be submitted in April 2015 as specified in Article 19(3) of this Regulation. All data shall be broken down by gender. (1) Common immediate result indicators for participants \"Participants\" (1) refers to persons benefiting directly from a YEI intervention who can be identified and asked for their characteristics, and for whom specific expenditure is earmarked. The immediate result indicators are: \u2014 Unemployed participants who complete the YEI supported intervention*, \u2014 Unemployed participants who receive an offer of employment, continued education, apprenticeship or traineeship upon leaving*, \u2014 Unemployed participants who are in education/training, gain a qualification, or are in employment, including self-employment, upon leaving*, \u2014 Long-term unemployed participants who complete the YEI supported intervention*, \u2014 Long-term unemployed participants who receive an offer of employment, continued education, apprenticeship or traineeship upon leaving*, \u2014 Long-term unemployed participants who are in education/training, gain a qualification, or are in employment, including self-employment, upon leaving*, \u2014 Inactive participants not in education or training who complete the YEI supported intervention*, \u2014 Inactive participants not in education or training who receive an offer of employment, continued education, apprenticeship or traineeship upon leaving*, \u2014 Inactive participants not in education or training who are in education/training, gain a qualification, or are in employment, including self-employment, upon leaving*. (2) Common longer-term result indicators for participants The longer-term result indicators are: \u2014 Participants in continued education, training programmes leading to a qualification, an apprenticeship or a traineeship six months after leaving*, \u2014 Participants in employment six months after leaving*, \u2014 Participants in self-employment six months after leaving*. The data for longer-term result indicators shall be collected based on a representative sample of participants within each investment priority. Internal validity of the sample shall be ensured in such a way that the data can be generalised at the level of investment priority. (1) Managing authorities shall establish a system that records and stores individual participant data in computerised form as set out in Article 125 (2) (d) of Regulation (EU) No 1303/2013 The data processing arrangements put in place by the Member States must be in line with the provisions of Directive 95/46/EC, in particular Articles 7 and 8 thereof. Data reported under the indicators marked with * are personal data according to Article 7 of Directive 95/46/EC. Their processing is necessary for compliance with the legal obligation to which the controller is subject (Article 7(c) of Directive 95/46/EC). For the definition of controller, see Article 2 of Directive 95/46/EC. Data reported under the indicators marked with ** are a special category of data according to Article 8 of Directive 95/46/EC. Subject to the provision of suitable safeguards, Member States may, for reasons of substantial public interest, lay down exemptions in addition to those laid down in Article 8(2) of Directive 95/46/EC, either by national law or by decision of the supervisory authority (Article 8(4) of Directive 95/46/EC). ANNEX III Correlation table European Parliament and Council Regulation (EC) No 1081/2006 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 Article 3 Article 4 Article 4 Article 5 Article 5 Article 6 Article 6 Article 7 Article 8 Article 7 Article 9 Article 8 Article 10 Article 9 \u2014 Article 10 \u2014 Article 11 Article 12 Article 11 Article 13 Article 14 Article 15 Articles 16 to 23 Article 24 Article 25 Article 12 Article 26 Article 13 Article 27 Article 14 Article 28 Article 15 Article 29", "summary": "European Social Fund European Social Fund SUMMARY OF: Regulation (EU) 1304/2013 \u2014 the European Social Fund WHAT IS THE AIM OF THE REGULATION? It sets down principles, rules and standards for the implementation of the European Social Fund (ESF). In 2014-2020, the ESF covers 4 main areas of investment: employment and in particular youth employment;social inclusion;education; andgood governance (i.e. improved quality of public administration). KEY POINTS Overall aimsThe ESF invests in people with the aim of improving employment and education opportunities across the EU. Over the 2014-2020 period, it aims to pay particular attention to vulnerable groups, including youth. The regulation describes the scope of the ESF and its relationship with the Youth Employment Initiative (YEI). Key themes The ESF focuses on a number of key themes including: promoting employment and supporting labour mobility; promoting social inclusion and combating poverty; investing in education, skills and lifelong learning; enhancing institutional capacity and the efficiency of public administration. Eligible regionsAll EU countries are eligible for funding from the ESF. A wide range of organisations, from both the public and private sectors, can apply through the EU countries. Budget priorities For the first time, a minimum share has been introduced for the ESF, set at 23.1% of cohesion policy which corresponds to more than \u20ac80 billion earmarked for ESF programming during the 2014-2020 programming period.In each EU country, at least 20% of the ESF must be earmarked for social inclusion and combating poverty. This means helping vulnerable people and disadvantaged groups to get the skills and jobs they need to integrate in the labour market.The ESF must provide targeted help for young people by topping up the YEI with at least \u20ac3.2 billion. This initiative must exclusively support young people not in employment, education or training in regions experiencing youth unemployment rates above 25%.In light of the need to address the persistently high levels of youth unemployment in the EU, Regulation (EU) 2015/779 amends Regulation (EU) No 1304/2013. It increases the level of the initial pre-financing paid to operational programmes supported by the YEI in 2015 from 1% to 30%. Focus on resultsThe programmes must be results-oriented and based on the additionality principle*. The concentration mechanism (i.e. very focused measures on a given target group) is important in order to make a real impact on the ground.ImplementationPartnership Agreements and operational programmes, agreed between the EU countries and the European Commission, set the framework for strategic investments at national and regional level. Public Private Partnerships Regulation (EU) No 1303/2013 stipulates that in relation to a Public Private Partnership (\u2018PPP\u2019) operation a beneficiary may be a body governed by private law of an EU country (\u2018private partner\u2019). The private partner (selected to implement the operation) may be replaced as beneficiary during implementation \u2014 where this is required \u2014 under the terms and conditions of the PPP or of the underlying financing agreement between the private partner and the financial institution co-financing the operation. Commission Delegated Regulation (EU) 2015/1076 lays down additional rules on the replacement of the beneficiary and on the related responsibilities. In the case of the replacement of a beneficiary in a PPP operation funded by European Structural and Investment Funds (ESIFs), it is necessary to ensure that after the replacement, the new partner or body provides at least the same service and with the same minimum quality standards, which was required by the initial PPP contract. This regulation also sets out procedures with regard to proposals to replace the private partner and confirmation of the private partner, as well as minimum requirements to be included in PPP agreements funded by ESIFs. FROM WHEN DOES THE REGULATION APPLY? It has applied since 21 December 2013. BACKGROUND For more information, see: European Social Fund (European Commission). KEY TERMS Additionality principle: ESF funding may not replace national spending by an EU country. MAIN DOCUMENT Regulation (EU) 1304/2013 of the European Parliament and of the Council of 17 December 2013 on the European Social Fund and repealing Council Regulation (EC) No 1081/2006 (OJ L 347, 20.12.2013, pp. 470-486) Successive amendments to Regulation (EU) 1304/2013 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2015/1076 of 28 April 2015 laying down, pursuant to Regulation (EU) No 1303/2013 of the European Parliament and of the Council, additional rules on the replacement of a beneficiary and on the related responsibilities, and minimum requirements to be included in Public Private Partnership agreements funded by the European Structural and Investment Funds (OJ L 175, 4.7.2015, pp. 1-3) Commission Implementing Regulation (EU) No 288/2014 of 25 February 2014 laying down rules pursuant to Regulation (EU) No 1303/2013 of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund with regard to the model for operational programmes under the Investment for growth and jobs goal and pursuant to Regulation (EU) No 1299/2013 of the European Parliament and of the Council on specific provisions for the support from the European Regional Development Fund to the European territorial cooperation goal with regard to the model for cooperation programmes under the European territorial cooperation goal (OJ L 87, 22.3.2014, pp. 1-48) Commission Implementing Decision 2014/99/EU of 18 February 2014 setting out the list of regions eligible for funding from the European Regional Development Fund and the European Social Fund and of Member States eligible for funding from the Cohesion Fund for the period 2014-2020 (OJ L 50, 20.2.2014, pp. 22-34) See consolidated version. Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (OJ L 347, 20.12.2013, pp. 320-469) See consolidated version. last update 08.05.2018"}
{"article": "10.12.2013 EN Official Journal of the European Union L 330/39 REGULATION (EU) No 1260/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 November 2013 on European demographic statistics (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 338(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) According to Article 16(4) of the Treaty on European Union (TEU), as from 1 November 2014, a qualified majority of the members of the Council is to be defined, inter alia, on the basis of the population of the Member States. (2) The Economic and Financial Affairs Council regularly gives a mandate to the Economic Policy Committee to assess the long-term sustainability and quality of public finances on the basis of population projections produced by Eurostat. (3) In accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council (2), all Member State statistics transmitted to the Commission which are broken down by territorial units are to use the NUTS classification. Consequently, in order to establish comparable regional statistics, the territorial units should be defined in accordance with the NUTS classification. (4) In accordance with the second paragraph of Article 175 of the Treaty on the Functioning of the European Union (TFEU), the Commission is to submit a report to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions every three years on the progress made towards achieving economic, social and territorial cohesion. Annual regional data at NUTS 3 regional level is necessary for the preparation of those reports and for the regular monitoring of demographic developments and of possible future demographic challenges in the Union regions, including different types of regions such as border regions, metropolitan regions, rural regions and mountain and island regions. Since demographic ageing exhibits strong regional differences, Eurostat is required to prepare regional projections on a regular basis in order to complement the demographic picture of the NUTS 2 regions in the Union. (5) In accordance with Article 159 TFEU, the Commission is to draw up a report each year on progress in achieving the objectives of Article 151 TFEU, including the demographic situation in the Union. (6) The Commission in its Communication of 20 October 2009 entitled \u2018Solidarity in health: reducing health inequalities in the EU\u2019 supported the further development and collection of data, and the further development of health indicators, by age, sex, socioeconomic status and geographic dimensions. (7) The Sustainable Development Strategy of the Union, launched by the European Council in Gothenburg in 2001 and renewed in June 2006, has as its objective the continuous improvement of the quality of life for current and future generations. The Commission (Eurostat) monitoring report, which is published every two years, provides an objective statistical picture of progress, based on a Union set of sustainable development indicators. (8) Annual demographic statistics are fundamental for the study and definition of a wide range of policies, with particular regard to social and economic issues, at national and regional level. Statistics on population are an important denominator for a wide range of policy indicators. (9) The strategic objective H.3. of Chapter IV of the Beijing Platform for Action (1995) provides a reference framework for the generation and dissemination of gender-disaggregated data and information for planning and policy evaluation reasons. (10) Demographic statistics constitute an essential component for the estimation of total population in the framework of the European System of Accounts. It is important to update and revise data when establishing statistics at European level. (11) In order to ensure the quality, and in particular the comparability, of the data provided by the Member States, and in order for reliable overviews to be drawn up at Union level, the data used should be based on the same concepts, and should refer to the same reference date or period. (12) Regulation (EC) No 223/2009 of the European Parliament and of the Council (3) provides a reference framework for European demographic statistics. In particular, it requires compliance with the principles of professional independence, impartiality, objectivity, reliability, statistical confidentiality and cost effectiveness. (13) The information on demography should be consistent with the relevant information collected pursuant to Regulation (EC) No 862/2007 of the European Parliament and of the Council (4) and Regulation (EC) No 763/2008 of the European Parliament and of the Council (5). To this end, scientifically-based and well-documented statistical estimation methods should be evaluated, and their use should be encouraged. (14) When developing, producing and disseminating European statistics, the national and European statistical authorities, and, where applicable, other relevant national and regional authorities, should take account of the principles set out in the European Statistics Code of Practice, as reviewed and updated by the European Statistical System Committee on 28 September 2011. (15) This Regulation guarantees the right to respect for private and family life and to the protection of personal data, as set out in Articles 7 and 8 of the Charter of Fundamental Rights of the European Union. (16) Directive 95/46/EC of the European Parliament and of the Council (6) and Regulation (EC) No 45/2001 of the European Parliament and of the Council (7) apply with regard to the processing of personal data in the context of this Regulation. (17) Since the objective of this Regulation, namely the establishment of a common legal framework for the systematic production of European demographic statistics in the Member States, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (18) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (8), HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes a common legal framework for the development, production and dissemination of European statistics on population and vital events. Article 2 Definitions For the purpose of this Regulation, the following definitions apply: (a) \u2018national\u2019 refers to the territory of a Member State within the meaning of Regulation (EC) No 1059/2003 applicable at the reference time; (b) \u2018regional\u2019 means NUTS level 1, NUTS level 2 or NUTS level 3 within the meaning of Regulation (EC) No 1059/2003 applicable at the reference time; where this term is used in connection with countries that are not members of the Union, \u2018regional\u2019 means the statistical regions at level 1, 2 or 3, as agreed between those countries and the Commission (Eurostat), at the reference time; (c) \u2018usually resident population\u2019 means all persons having their usual residence in a Member State at the reference time; (d) \u2018usual residence\u2019 means the place where a person normally spends the daily period of rest, regardless of temporary absences for purposes of recreation, holidays, visits to friends and relatives, business, medical treatment or religious pilgrimage. The following persons alone shall be considered to be usual residents of a specific geographical area: (i) those who have lived in their place of usual residence for a continuous period of at least 12 months before the reference time; or (ii) those who arrived in their place of usual residence during the 12 months before the reference time with the intention of staying there for at least one year. Where the circumstances described in point (i) or (ii) cannot be established, \u2018usual residence\u2019 can be taken to mean the place of legal or registered residence, except for the purposes of Article 4. In applying the definition of \u2018usual residence\u2019, Member States shall treat special cases in accordance with the Annex to Commission Regulation (EC) No 1201/2009 (9); (e) \u2018live birth\u2019 means the birth of a child who breathes or shows any other evidence of life, such as beating of the heart, pulsation of the umbilical cord or definite movement of voluntary muscles, regardless of gestational age; (f) \u2018death\u2019 means the permanent disappearance of all evidence of life at any time after live birth has taken place (post-natal cessation of vital functions without capability of resuscitation); (g) \u2018vital events\u2019 means live births and deaths as defined in points (e) and (f). Article 3 Data on population and on vital events 1. Member States shall provide the Commission (Eurostat) with data on their usually resident population at the reference time. The data provided shall cover population by age, sex and region of residence. 2. Member States shall provide the Commission (Eurostat) with data on their vital events that occurred during the reference period. Member States shall use the same population definition that they use for the data referred to in paragraph 1. The data provided shall cover the following variables: (a) live births by sex, month of occurrence, live birth-order, mother\u2019s age, mother\u2019s year of birth, mother\u2019s country of birth, mother\u2019s country of citizenship and mother\u2019s region of residence; (b) deaths by age, sex, year of birth, region of residence, country of birth, country of citizenship and month of occurrence. 3. Member States shall use the same definition of population for all \u2018national\u2019 and \u2018regional\u2019 levels as defined by this Regulation. 4. The Commission shall adopt implementing acts laying down uniform conditions for the breakdown of data referred to in paragraphs 1 and 2, for deadlines and for revisions of data. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 10(2). Article 4 Total population for specific Union purposes 1. For the purposes of qualified majority voting in the Council, Member States shall provide the Commission (Eurostat) with data on the total population at national level at the reference time, in accordance with Article 2(c), within eight months of the end of the reference year. 2. Member States may estimate the total population referred to in paragraph 1 from the legally resident or registered population using scientifically-based, well-documented, and publicly available statistical estimation methods. Article 5 Frequency and reference time 1. Each year, Member States shall provide the Commission (Eurostat) with data on their population and on their vital events for the previous year referred to in Article 3(1) and in points (a) and (b) of Article 3(2). 2. Each year Member States shall provide the Commission (Eurostat) with data on the total population at national level referred to in Article 4. 3. For the purposes of this Regulation, the reference time shall mean either the reference date referred to in paragraph 4 or the reference period referred to in paragraph 5, as appropriate. 4. The reference date for population data shall be the end of the reference period (midnight of 31 December). The first reference date shall be in 2013 and the last reference date shall be in 2027. 5. The reference period for vital events data shall be the calendar year in which the events occurred. The first reference period shall be 2013 and the last reference period shall be 2027. Article 6 Provision of data and metadata Member States shall make available to the Commission (Eurostat) the data and metadata required under this Regulation in accordance with the data and metadata exchange standards specified by the Commission (Eurostat). Member States shall either provide those data and metadata through the Single Entry Point services so that the Commission (Eurostat) can retrieve them, or shall transmit them using the Single Entry Point services. Article 7 Data sources The data shall be based on the data sources chosen by the Member State in accordance with national law and practice. Scientifically-based and well-documented statistical estimation methods shall be used, where appropriate. Article 8 Feasibility studies 1. Member States shall carry out feasibility studies on the use of the definition of \u2018usual residence\u2019 for population and vital events as referred to in Article 3(1) and (2). 2. The results of the feasibility studies referred to in paragraph 1 shall be transmitted to the Commission by 31 December 2016. 3. In order to facilitate the carrying out of the feasibility studies referred to in paragraph 1 of this Article, the Union may provide financial support to the national statistical institutes and other national authorities referred to in Article 5 of Regulation (EC) No 223/2009. Article 9 Quality requirements 1. Member States shall ensure the quality of the data transmitted. 2. For the purposes of this Regulation, the quality criteria referred to in Article 12(1) of Regulation (EC) No 223/2009 shall apply to the data to be transmitted. 3. Member States shall report to the Commission (Eurostat) on reference metadata, using the European Statistical System standards, and in particular on the data sources, definitions and estimation methods used for the first reference year, and Member States shall keep the Commission (Eurostat) informed of any changes thereto. 4. At the request of the Commission (Eurostat), Member States shall provide it with all the information necessary to evaluate the quality of the statistical information. 5. Member States shall ensure that the data on population required by Article 3 of this Regulation are consistent with those required by point (c) of Article 3(1) of Regulation (EC) No 862/2007. Article 10 Committee procedure 1. The Commission shall be assisted by the European Statistical System Committee established by Regulation (EC) No 223/2009. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 11 Review Clause 1. The Commission shall submit a first report to the European Parliament and to the Council on the implementation of this Regulation by 31 December 2018, and a second report by 31 December 2023. In those reports, the Commission shall take account of relevant information provided by Member States and shall evaluate the quality of the data transmitted, the data collection methods used, the additional burden imposed on the Member States and on the respondents, and the comparability of those statistics. Those reports shall evaluate the use of scientifically-based, well-documented statistical estimation methods, for the estimation of the \u2018usually resident population\u2019 from the legally resident or registered population. The first report shall also cover the results of the feasibility studies referred to in Article 8. 2. If appropriate, those reports shall be accompanied by proposals designed to further improve the common legal framework for the development, production and dissemination of European statistics on population and vital events under this Regulation. Article 12 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall cease to apply on 31 August 2028. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 20 November 2013. For the European Parliament The President M. SCHULZ For the Council The President V. LE\u0160KEVI\u010cIUS (1) Position of the European Parliament of 22 October 2013 (not yet published in the Official Journal) and decision of the Council of 15 November 2013. (2) Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1). (3) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (4) Regulation (EC) No 862/2007 of the European Parliament and of the Council of 11 July 2007 on Community statistics on migration and international protection and repealing Council Regulation (EEC) No 311/76 on the compilation of statistics on foreign workers (OJ L 199, 31.7.2007, p. 23). (5) Regulation (EC) No 763/2008 of the European Parliament and of the Council of 9 July 2008 on population and housing censuses (OJ L 218, 13.8.2008, p. 14). (6) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (7) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (8) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (9) Commission Regulation (EC) No 1201/2009 of 30 November 2009 implementing Regulation (EC) No 763/2008 of the European Parliament and of the Council on population and housing censuses as regards the technical specifications of the topics and of their breakdowns (OJ L 329, 15.12.2009, p. 29).", "summary": "Demography statistics Demography statistics SUMMARY OF: Regulation (EU) No 1260/2013 on European demographic statistics WHAT IS THE AIM OF THE REGULATION? It seeks to regulate the harmonisation and provision of data on population and on vital events (i.e. births and deaths) linked to the population. It lays down common definitions, subjects covered and characteristics of the required information, coverage, quality criteria and reporting deadlines and results although EU countries will compile the data using their own national sources and practices. KEY POINTS Why are these statistics important? 1.High-quality population estimates are vital for the EU\u2019s democratic process, i.e. they are important in the calculation of the weighting of votes as in the case of qualified majority voting in the Council. Since 1 November 2014, a qualified majority is defined as at least 55 % of the members of the Council, comprising at least 15 of them and representing countries comprising at least 65 % of the population of the EU (double majority). 2.The long-term assessment of the sustainability of EU countries\u2019 public finances is, among other things, conducted on the basis of Eurostat population projections; these, in turn, require timely, accurate, reliable and consistent time series on population, births and deaths, together with sound assumptions concerning the future development of fertility, life expectancy and migration flows. 3.Progress of the EU\u2019s sustainable development strategy is assessed via the Eurostat monitoring report which uses time series on old-age dependency ratios, fertility rates and life expectancy in the EU. 4.Trends in achieving economic, social and territorial cohesion are assessed on the basis of regional demographic data. Commission Implementing Regulation (EU) No 205/2014 lays down uniform conditions for the implementation of Regulation (EU) No 1260/2013 as regards the breakdown (i.e. disaggregation) of data, deadlines and data revisions. FROM WHEN DOES THE REGULATION APPLY? It has applied since 30 December 2013. BACKGROUND For more information see: \u2018Population (demography, migration and projections)\u2019 on Eurostat's website. ACT Regulation (EU) No 1260/2013 of the European Parliament and of the Council of 20 November 2013 on European demographic statistics (OJ L 330, 10.12.2013, pp. 39-43) RELATED ACTS Commission Implementing Regulation (EU) No 205/2014 of 4 March 2014 laying down uniformed conditions for the implementation of Regulation (EU) No 1260/2013 of the European Parliament and the Council on European demographic statistics, as regards breakdowns of data, deadlines and data revisions (OJ L 65, 5.3.2014, pp. 10-26) last update 03.08.2016"}
{"article": "18.10.2011 EN Official Journal of the European Union L 272/1 REGULATION (EU) No 1007/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Council Directive 73/44/EEC of 26 February 1973 on the approximation of the laws of the Member States relating to the quantitative analysis of ternary fibre mixtures (3), Directive 96/73/EC of the European Parliament and of the Council of 16 December 1996 on certain methods for the quantitative analysis of binary textile fibre mixtures (4) and Directive 2008/121/EC of the European Parliament and of the Council of 14 January 2009 on textile names (5) have been amended several times. Since further amendments are to be made, those acts should be replaced by a single legal instrument, in the interest of clarity. (2) The legal acts of the Union on textile fibre names and related labelling and marking of fibre composition of textile products are very technical in their content, with detailed provisions that need to be adapted regularly. In order to avoid the need for Member States to transpose the technical amendments into national legislation and thus reduce the administrative burden for national authorities and in order to allow for a faster adoption of new textile fibre names to be used simultaneously throughout the Union, a regulation seems to be the most appropriate legal instrument to carry out the legislative simplification. (3) In order to eliminate potential obstacles to the proper functioning of the internal market caused by Member States' diverging provisions with regard to textile fibre names and related labelling and marking of fibre composition of textile products, it is necessary to harmonise the names of textile fibres and the indications appearing on labels, markings and documents which accompany textile products at the various stages of their production, processing and distribution. (4) The labelling and marking requirements laid down in this Regulation should not apply in cases where textile products are contracted out to persons working in their own homes or to independent firms that carry out work from materials supplied to them without the property therein being transferred for consideration or where customised textile products are made up by self-employed tailors. However, those exemptions should be limited to the transactions between those persons working in their own homes or independent firms and the persons contracting out work to them, and between self-employed tailors and consumers. (5) This Regulation lays down harmonised provisions with regard to certain aspects of textile labelling and marking, in particular textile fibre names. Other labelling and marking may exist, provided that it does not cover the same scope as this Regulation and that it is compatible with the Treaties. (6) It is appropriate to lay down rules enabling manufacturers to ask for the inclusion of a new textile fibre name in the Annexes to this Regulation. (7) Provision should also be made in respect of certain products which are not made exclusively of textile materials but have a textile content which constitutes an essential part of the product or to which attention is specifically drawn by the economic operator. (8) It is appropriate to lay down rules concerning the labelling or marking of certain textile products which contain non-textile parts of animal origin. This Regulation should, in particular, set out the requirement to indicate the presence of non-textile parts of animal origin on the labelling or marking of textile products containing such parts, in order to enable consumers to make informed choices. The labelling or marking should not be misleading. (9) The tolerance in respect of \u2018extraneous fibres\u2019, which are not to be stated on the labels and markings, should apply both to pure products and to mixtures. (10) Labelling or marking of the fibre composition should be compulsory to ensure that correct and uniform information is made available to all consumers in the Union. However, this Regulation should not prevent economic operators from indicating, in addition, the presence of small quantities of fibres requiring particular attention to keep the original quality of the textile product. Where it is technically difficult to specify the fibre composition of a textile product at the time of its manufacture, it should be possible to state, on the label or marking, only those fibres which are known at the time of manufacture provided that they account for a certain percentage of the finished product. (11) In order to avoid differences in practice among the Member States, it is necessary to lay down the exact methods of labelling or marking for certain textile products consisting of two or more components, and also to specify the components of textile products that need not be taken into account for the purposes of labelling, marking and analysis. (12) Textile products subject only to the requirements of inclusive labelling, and those sold by the metre or in cut lengths, should be made available on the market in such a way that the consumer can fully acquaint himself with the information affixed to the overall packaging or the roll. (13) The use of textile fibre names or descriptions of fibre compositions which enjoy particular prestige among users and consumers should be made subject to certain conditions. Furthermore, in order to provide information to users and consumers, it is appropriate that the textile fibre names are related to the characteristics of the fibre. (14) The market surveillance in Member States of products covered by this Regulation is subject to Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (6) and Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (7). (15) It is necessary to lay down methods for the sampling and analysis of textile products in order to exclude any possibility of objections to the methods used. The methods used for official tests carried out in the Member States to determine the fibre composition of textile products composed of binary and ternary fibre mixtures should be uniform, as regards both the pre-treatment of the sample and its quantitative analysis. In order to simplify this Regulation and adapt the uniform methods set out therein to technical progress, it is appropriate that those methods be turned into harmonised standards. To that end, the Commission should manage the transition from the current system, which is based on the methods set out in this Regulation, to a harmonised standard-based system. The use of uniform methods of analysis of textile products composed of binary and ternary fibre mixtures will facilitate the free movement of those products, and thereby improve the functioning of the internal market. (16) In the case of binary textile fibre mixtures for which there is no uniform method of analysis at Union level, the laboratory responsible for the test should be allowed to determine the composition of such mixtures, indicating in the analysis report the result obtained, the method used and its degree of accuracy. (17) This Regulation should set out the agreed allowances to be applied to the anhydrous mass of each fibre during the determination by analysis of the fibre content of textile products, and should give two different agreed allowances for calculating the composition of carded or combed fibres containing wool and/or animal hair. Since it cannot always be established whether a product is carded or combed, and consequently inconsistent results can arise from the application of the tolerances during checks on the conformity of textile products carried out in the Union, the laboratories carrying out those checks should be authorised to apply a single agreed allowance in doubtful cases. (18) Rules should be laid down in respect of products exempt from the general labelling and marking requirements set out in this Regulation, in particular with respect to disposable products or products for which only inclusive labelling is required. (19) Misleading commercial practices, involving the provision of false information that would cause consumers to take a transactional decision that they would not have taken otherwise, are prohibited by Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (8) and are covered by Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection law (9). (20) Consumer protection requires transparent and consistent trade rules, including as regards indications of origin. When such indications are used, they should enable consumers to be fully aware of the origin of the products they purchase, so as to protect them against fraudulent, inaccurate or misleading claims of origin. (21) The European textiles sector is affected by counterfeiting, which poses problems in terms of consumer protection and information. Member States should pay particular attention to the implementation of horizontal Union legislation and measures regarding counterfeit products in the field of textile products, for example Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (10). (22) It is appropriate to establish a procedure for the inclusion of new textile fibre names in the Annexes to this Regulation. This Regulation should thus set out requirements regarding applications by manufacturers or other persons acting on their behalf for new textile fibre names to be added to those Annexes. (23) It is necessary that manufacturers, or other persons acting on their behalf, who wish to add a new textile fibre name to the Annexes to this Regulation, include in the technical file to be submitted with their application available scientific information concerning possible allergic reactions or other adverse effects of the new textile fibre on human health, including results of tests conducted to that effect in compliance with relevant Union legislation. (24) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the adoption of technical criteria and procedural rules for the authorisation of higher tolerances, the amendment of Annexes II, IV, V, VI, VII, VIII and IX in order to adapt them to technical progress and the amendment of Annex I in order to include new textile fibre names in the list set out in that Annex. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (25) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (26) In order to eliminate possible obstacles to the proper functioning of the internal market caused by divergent provisions or practices of Member States, and in order to keep pace with the development of electronic commerce and future challenges in the market for textile products, the harmonisation or standardisation of other aspects of textile labelling should be examined. To that end, the Commission is invited to submit a report to the European Parliament and to the Council regarding possible new labelling requirements to be introduced at Union level with a view to facilitating the free movement of textile products in the internal market and to achieving a high level of consumer protection throughout the Union. That report should examine in particular consumer views relating to the amount of information that should be supplied on the label of textile products, and investigate which means other than labelling may be used to provide additional information to consumers. The report should be based on an extended consultation of relevant stakeholders, including consumers, and should take into account existing related European and international standards. The report should examine, in particular: the scope and features of possible harmonised rules on the indication of origin, taking into account the results of developments on potential horizontal country-of-origin rules; the added value to the consumer of possible labelling requirements relating to care instructions, size, hazardous substances, flammability and environmental performance of the textile products; the use of language-independent symbols or codes for identifying the textile fibres contained in a textile product, enabling the consumer to understand easily the composition and, in particular, the use of natural or synthetic fibres; social labelling and electronic labelling; as well as the inclusion of an identification number on the label to obtain additional on-demand information, especially via the Internet, about the product and the manufacturer. The report should be accompanied, where appropriate, by legislative proposals. (27) The Commission should carry out a study to evaluate whether there is a causal link between allergic reactions and chemical substances or mixtures used in textile products. On the basis of that study, the Commission should, where appropriate, submit legislative proposals in the context of existing Union legislation. (28) Directives 73/44/EEC, 96/73/EC and 2008/121/EC should be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER 1 GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down rules concerning the use of textile fibre names and related labelling and marking of fibre composition of textile products, rules concerning the labelling or marking of textile products containing non-textile parts of animal origin and rules concerning the determination of the fibre composition of textile products by quantitative analysis of binary and ternary textile fibre mixtures, with a view to improving the functioning of the internal market and to providing accurate information to consumers. Article 2 Scope 1. This Regulation shall apply to textile products when made available on the Union market and to the products referred to in paragraph 2. 2. For the purposes of this Regulation, the following products shall be treated in the same way as textile products: (a) products containing at least 80 % by weight of textile fibres; (b) furniture, umbrella and sunshade coverings containing at least 80 % by weight of textile components; (c) the textile components of: (i) the upper layer of multi-layer floor coverings; (ii) mattress coverings; (iii) coverings of camping goods; provided such textile components constitute at least 80 % by weight of such upper layers or coverings; (d) textiles incorporated in other products and forming an integral part thereof, where their composition is specified. 3. This Regulation shall not apply to textile products which are contracted out to persons working in their own homes or to independent firms that carry out work from materials supplied without the property therein being transferred for consideration. 4. This Regulation shall not apply to customised textile products made up by self-employed tailors. Article 3 Definitions 1. For the purposes of this Regulation, the following definitions shall apply: (a) \u2018textile product\u2019 means any raw, semi-worked, worked, semi-manufactured, manufactured, semi-made-up or made-up product which is exclusively composed of textile fibres, regardless of the mixing or assembly process employed; (b) \u2018textile fibre\u2019 means either of the following: (i) a unit of matter characterised by its flexibility, fineness and high ratio of length to maximum transverse dimension, which render it suitable for textile applications; (ii) a flexible strip or tube, of which the apparent width does not exceed 5 mm, including strips cut from wider strips or films, produced from the substances used for the manufacture of the fibres listed in Table 2 of Annex I and suitable for textile applications; (c) \u2018apparent width\u2019 means the width of the strip or tube when folded, flattened, compressed or twisted, or the average width where the width is not uniform; (d) \u2018textile component\u2019 means a part of a textile product with an identifiable fibre content; (e) \u2018extraneous fibres\u2019 means fibres other than those stated on the label or marking; (f) \u2018lining\u2019 means a separate component used in making up garments and other products, consisting of a single layer or multiple layers of textile material held in place along one or more of the edges; (g) \u2018labelling\u2019 means affixing the required information to the textile product by way of attaching a label; (h) \u2018marking\u2019 means indicating the required information directly on the textile product by way of sewing, embroidering, printing, embossing or any other technology of application; (i) \u2018inclusive labelling\u2019 means the use of a single label for several textile products or components; (j) \u2018disposable product\u2019 means a textile product designed to be used only once or for a limited time, and the normal use of which is not intended for subsequent use for the same or a similar purpose; (k) \u2018agreed allowance\u2019 means the value of moisture regain to be used in the calculation of the percentage of fibre components on a clean, dry mass basis, with adjustment by conventional factors. 2. For the purposes of this Regulation, the definitions of \u2018making available on the market\u2019, \u2018placing on the market\u2019, \u2018manufacturer\u2019, \u2018importer\u2019, \u2018distributor\u2019, \u2018economic operators\u2019, \u2018harmonised standard\u2019, \u2018market surveillance\u2019 and \u2018market surveillance authority\u2019 set out in Article 2 of Regulation (EC) No 765/2008 shall apply. Article 4 General requirement on the making available on the market of textile products Textile products shall only be made available on the market provided that such products are labelled, marked or accompanied with commercial documents in compliance with this Regulation. CHAPTER 2 TEXTILE FIBRE NAMES AND RELATED LABELLING AND MARKING REQUIREMENTS Article 5 Textile fibre names 1. Only the textile fibre names listed in Annex I shall be used for the description of fibre compositions on labels and markings of textile products. 2. Use of the names listed in Annex I shall be reserved for textile fibres the nature of which corresponds to the description set out in that Annex. The names listed in Annex I shall not be used for other fibres, whether on their own or as a root or as an adjective. The term \u2018silk\u2019 shall not be used to indicate the shape or particular presentation in continuous filament yarn of textile fibres. Article 6 Applications for new textile fibre names Any manufacturer or any person acting on a manufacturer's behalf may apply to the Commission to add a new textile fibre name to the list set out in Annex I. The application shall include a technical file compiled in accordance with Annex II. Article 7 Pure textile products 1. Only textile products exclusively composed of the same fibre may be labelled or marked as \u2018100 %\u2019, \u2018pure\u2019 or \u2018all\u2019. Those or similar terms shall not be used for other textile products. 2. Without prejudice to Article 8(3), a textile product containing no more than 2 % by weight of extraneous fibres may also be treated as exclusively composed of the same fibre, provided this quantity is justified as being technically unavoidable in good manufacturing practice and is not added as a matter of routine. A textile product which has undergone a carding process may also be treated as exclusively composed of the same fibre if it contains no more than 5 % by weight of extraneous fibres, provided this quantity is justified as being technically unavoidable in good manufacturing practice and is not added as a matter of routine. Article 8 Fleece wool or virgin wool products 1. A textile product may be labelled or marked by one of the names set out in Annex III provided it is composed exclusively of a wool fibre which has not previously been incorporated in a finished product, which has not been subjected to any spinning and/or felting processes other than those required in the manufacture of that product, and which has not been damaged by treatment or use. 2. By way of derogation from paragraph 1, the names listed in Annex III may be used to describe wool contained in a textile fibre mixture if all the following conditions are met: (a) all the wool contained in that mixture satisfies the requirements defined in paragraph 1; (b) such wool accounts for not less than 25 % of the total weight of the mixture; (c) in the case of a scribbled mixture, the wool is mixed with only one other fibre. The full percentage composition of such mixture shall be given. 3. The extraneous fibres in the products referred to in paragraphs 1 and 2, including wool products which have undergone a carding process, shall not exceed 0,3 % by weight, shall be justified as being technically unavoidable in good manufacturing practice and shall not be added as a matter of routine. Article 9 Multi-fibre textile products 1. A textile product shall be labelled or marked with the name and percentage by weight of all constituent fibres in descending order. 2. By way of derogation from paragraph 1, and without prejudice to Article 7(2), a fibre which accounts for up to 5 % of the total weight of the textile product, or fibres which collectively account for up to 15 % of the total weight of the textile product, may, where they cannot easily be stated at the time of the manufacture, be designated by the term \u2018other fibres\u2019, immediately preceded or followed by their total percentage by weight. 3. Products having a pure cotton warp and a pure flax weft, in which the percentage of flax accounts for at least 40 % of the total weight of the unsized fabric may be given the name \u2018cotton linen union\u2019 which must be accompanied by the composition specification \u2018pure cotton warp \u2014 pure flax (or linen) weft\u2019. 4. Without prejudice to Article 5(1), for textile products the composition of which is hard to state at the time of their manufacture, the term \u2018mixed fibres\u2019 or the term \u2018unspecified textile composition\u2019 may be used on the label or marking. 5. By way of derogation from paragraph 1 of this Article, fibres not yet listed in Annex I may be designated by the term \u2018other fibres\u2019, immediately preceded or followed by their total percentage by weight. Article 10 Decorative fibres and fibres with antistatic effect 1. Visible, isolable fibres which are purely decorative and do not exceed 7 % of the weight of the finished product do not have to be taken into account in the fibre compositions provided for in Articles 7 and 9. 2. Metallic fibres and other fibres which are incorporated in order to obtain an antistatic effect and which do not exceed 2 % of the weight of the finished product do not have to be taken into account in the fibre compositions provided for in Articles 7 and 9. 3. In the case of the products referred to in Article 9(4), the percentages provided for in paragraphs 1 and 2 of this Article shall be calculated on the weight of the warp and that of the weft separately. Article 11 Multi-component textile products 1. Any textile product containing two or more textile components which have different textile fibre contents shall bear a label or marking stating the textile fibre content of each component. 2. The labelling or marking referred to in paragraph 1 shall not be compulsory for textile components when the following two conditions are fulfilled: (a) those components are not main linings; and (b) those components represent less than 30 % of the total weight of the textile product. 3. Where two or more textile products have the same fibre content and normally form a single unit, they may bear only one label or marking. Article 12 Textile products containing non-textile parts of animal origin 1. The presence of non-textile parts of animal origin in textile products shall be indicated by using the phrase \u2018Contains non-textile parts of animal origin\u2019 on the labelling or marking of products containing such parts whenever they are made available on the market. 2. The labelling or marking shall not be misleading and shall be carried out in such a way that the consumer can easily understand. Article 13 Labelling and marking of textile products listed in Annex IV The fibre composition of textile products listed in Annex IV shall be indicated in accordance with the labelling and marking provisions set out in that Annex. Article 14 Labels and markings 1. Textile products shall be labelled or marked to give an indication of their fibre composition whenever they are made available on the market. The labelling and marking of textile products shall be durable, easily legible, visible and accessible and, in the case of a label, securely attached. 2. Without prejudice to paragraph 1, labels or markings may be replaced or supplemented by accompanying commercial documents when the products are being supplied to economic operators within the supply chain, or when they are delivered in performance of an order placed by any contracting authority as defined in Article 1 of Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (11). 3. The textile fibre names and descriptions of fibre compositions referred to in Articles 5, 7, 8 and 9 shall be clearly indicated in the accompanying commercial documents referred to in paragraph 2 of this Article. Abbreviations shall not be used with the exception of a mechanised processing code, or where the abbreviations are defined in international standards, provided that they are explained in the same commercial document. Article 15 Obligation to supply the label or marking 1. When placing a textile product on the market, the manufacturer shall ensure the supply of the label or marking and the accuracy of the information contained therein. If the manufacturer is not established in the Union, the importer shall ensure the supply of the label or marking and the accuracy of the information contained therein. 2. A distributor shall be considered a manufacturer for the purposes of this Regulation where he places a product on the market under his name or trademark, attaches the label himself or modifies the content of the label. 3. When making a textile product available on the market, the distributor shall ensure that textile products bear the appropriate labelling or marking prescribed by this Regulation. 4. The economic operators referred to in paragraphs 1, 2 and 3 shall ensure that any information supplied when textile products are made available on the market cannot be confused with the textile fibre names and the descriptions of fibre compositions, as laid down by this Regulation. Article 16 The use of textile fibre names and fibre composition descriptions 1. When making a textile product available on the market, the textile fibre composition descriptions referred to in Articles 5, 7, 8 and 9 shall be indicated in catalogues and trade literature, on packaging, labels and markings in a manner that is easily legible, visible, clear and in print which is uniform as regards its size, style and font. This information shall be clearly visible to the consumer before the purchase, including in cases where the purchase is made by electronic means. 2. Trade marks or the name of the undertaking may be given immediately before or after textile fibre composition descriptions referred to in Articles 5, 7, 8 and 9. However, where a trade mark or a name of an undertaking contains, on its own or as a root or as an adjective, one of the textile fibre names listed in Annex I or a name liable to be confused therewith, such trade mark or name shall be given immediately before or after the textile fibre composition descriptions referred to in Articles 5, 7, 8 and 9. Other information shall be always displayed separately. 3. The labelling or marking shall be provided in the official language or languages of the Member State on the territory of which the textile products are made available to the consumer, unless the Member State concerned provides otherwise. In the case of bobbins, reels, skeins, balls or other small quantities of sewing, mending and embroidery yarns, the first subparagraph shall apply to the inclusive labelling referred to in Article 17(3). Whenever these products are individually sold, they may be labelled or marked in any of the official languages of the institutions of the Union, provided they are also inclusively labelled. Article 17 Derogations 1. The rules laid down in Articles 11, 14, 15 and 16 shall be subject to the derogations provided for in paragraphs 2, 3 and 4 of this Article. 2. The indication of textile fibre names or fibre composition on the labels and markings of textile products listed in Annex V is not required. However, where a trade mark or name of an undertaking contains, on its own or as a root or as an adjective, one of the names listed in Annex I or a name liable to be confused therewith, Articles 11, 14, 15 and 16 shall apply. 3. Where textile products listed in Annex VI are of the same type and fibre composition, they may be made available on the market together with an inclusive labelling. 4. The fibre composition of textile products sold by the metre may be shown on the length or roll made available on the market. 5. The textile products referred to in paragraphs 3 and 4 shall be made available on the market in such a way that the fibre composition of those products is made known to each purchaser in the supply chain, including the consumer. CHAPTER 3 MARKET SURVEILLANCE Article 18 Market surveillance checks Market surveillance authorities shall carry out checks on the conformity of the fibre composition of textile products with the supplied information related to the fibre composition of those products in accordance with this Regulation. Article 19 Determination of fibre composition 1. For the purpose of determining the fibre composition of textile products, the checks referred to in Article 18 shall be carried out in accordance with the methods set out in Annex VIII or with the harmonised standards to be introduced in that Annex. 2. In the determination of fibre compositions set out in Articles 7, 8 and 9, the items listed in Annex VII shall not be taken into account. 3. The fibre compositions set out in Articles 7, 8 and 9 shall be determined by applying to the anhydrous mass of each fibre the appropriate agreed allowance laid down in Annex IX, after having removed the items set out in Annex VII. 4. The laboratories responsible for the testing of textile mixtures for which there is no uniform method of analysis at Union level shall determine the fibre composition of such mixtures, indicating in the analysis report the result obtained, the method used and its degree of accuracy. Article 20 Tolerances 1. For the purposes of establishing the fibre composition of textile products, the tolerances laid down in paragraphs 2, 3 and 4 shall apply. 2. Without prejudice to Article 8(3), the presence of extraneous fibres in the fibre composition to be provided in accordance with Article 9 does not need to be indicated if the percentage of those fibres does not reach the following values: (a) 2 % of the total weight of the textile product, provided this quantity is justified as being technically unavoidable in good manufacturing practice and is not added as a matter of routine; or (b) 5 % of the total weight in the case of textile products which have undergone a carding process, provided this quantity is justified as being technically unavoidable in good manufacturing practice and is not added as a matter of routine. 3. A manufacturing tolerance of 3 % shall be permitted between the stated fibre composition to be provided in accordance with Article 9 and the percentages obtained from analysis carried out in accordance with Article 19, in relation to the total weight of fibres shown on the label or marking. Such tolerance shall also apply to the following: (a) fibres which may be designated by the term \u2018other fibres\u2019 in accordance with Article 9; (b) the percentage of wool referred to in point (b) of Article 8(2). For the purposes of the analysis, the tolerances shall be calculated separately. The total weight to be taken into account in calculating the tolerance referred to in this paragraph shall be that of the fibres of the finished product less the weight of any extraneous fibres found when applying the tolerance referred to in paragraph 2 of this Article. 4. The cumulative application of the tolerances referred to in paragraphs 2 and 3 shall be permitted only if any extraneous fibres found by analysis, when applying the tolerance referred to in paragraph 2, prove to be of the same chemical type as one or more of the fibres shown on the label or marking. 5. In the case of particular textile products for which the manufacturing process requires tolerances higher than those laid down in paragraphs 2 and 3, the Commission may authorise higher tolerances. Prior to placing the textile product on the market, the manufacturer shall submit a request for authorisation by the Commission providing sufficient reasons for and evidence of the exceptional manufacturing circumstances. The authorisation may only be granted in exceptional cases and where adequate justification is provided by the manufacturer. If appropriate, the Commission shall adopt, by means of delegated acts in accordance with Article 22, technical criteria and procedural rules for the application of this paragraph. CHAPTER 4 FINAL PROVISIONS Article 21 Delegated acts 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 concerning the adoption of technical criteria and procedural rules for the application of Article 20(5), amendments to Annexes II, IV, V, VI, VII, VIII and IX, in order to take account of technical progress, and amendments to Annex I in order to include, pursuant to Article 6, new textile fibre names in the list set out in that Annex. 2. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 22 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 20(5) and Article 21 shall be conferred on the Commission for a period of five years from 7 November 2011. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 20(5) and Article 21 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 20(5) and Article 21 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 23 Reporting By 8 November 2014, the Commission shall submit a report to the European Parliament and to the Council on the application of this Regulation, with an emphasis on the requests for and adoption of new textile fibre names and submit, where appropriate, a legislative proposal. Article 24 Review 1. By 30 September 2013, the Commission shall submit a report to the European Parliament and to the Council regarding possible new labelling requirements to be introduced at Union level with a view to providing consumers with accurate, relevant, intelligible and comparable information on the characteristics of textile products. 2. The report shall be based on a consultation of relevant stakeholders and shall take into account existing related European and international standards. 3. The report shall be accompanied, where appropriate, by legislative proposals, and shall examine, inter alia, the following issues: (a) an origin labelling scheme aimed at providing consumers with accurate information on the country of origin and additional information ensuring full traceability of textile products, taking into account the results of developments on potential horizontal country-of-origin rules; (b) a harmonised care labelling system; (c) a Union-wide uniform size labelling system for relevant textile products; (d) an indication of allergenic substances; (e) electronic labelling and other new technologies, and the use of language-independent symbols or codes for the identification of fibres. Article 25 Study on hazardous substances By 30 September 2013, the Commission shall carry out a study to evaluate whether there is a causal link between allergic reactions and chemical substances or mixtures used in textile products. On the basis of that study, the Commission shall, where appropriate, submit legislative proposals in the context of existing Union legislation. Article 26 Transitional provision Textile products which comply with Directive 2008/121/EC and which are placed on the market before 8 May 2012 may continue to be made available on the market until 9 November 2014. Article 27 Repeal Directives 73/44/EEC, 96/73/EC and 2008/121/EC are hereby repealed with effect from 8 May 2012. References to the repealed Directives shall be construed as references to this Regulation and shall be read in accordance with the correlation tables in Annex X. Article 28 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 8 May 2012. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 27 September 2011. For the European Parliament The President J. BUZEK For the Council The President M. DOWGIELEWICZ (1) OJ C 255, 22.9.2010, p. 37. (2) Position of the European Parliament of 18 May 2010 (OJ C 161 E, 31.5.2011, p. 179) and position of the Council at first reading of 6 December 2010 (OJ C 50 E, 17.2.2011, p. 1). Position of the European Parliament of 11 May 2011 (not yet published in the Official Journal) and decision of the Council of 19 July 2011. (3) OJ L 83, 30.3.1973, p. 1. (4) OJ L 32, 3.2.1997, p. 1. (5) OJ L 19, 23.1.2009, p. 29. (6) OJ L 218, 13.8.2008, p. 30. (7) OJ L 11, 15.1.2002, p. 4. (8) OJ L 149, 11.6.2005, p. 22. (9) OJ L 364, 9.12.2004, p. 1. (10) OJ L 196, 2.8.2003, p. 7. (11) OJ L 134, 30.4.2004, p. 114. ANNEX I List of textile fibre names (referred to in Article 5) Table 1 Number Name Fibre description 1 wool fibre from sheep's or lambs\u2019 fleeces (Ovis aries) or a mixture of fibres from sheep's or lambs\u2019 fleeces and the hairs of animals listed in number 2 2 alpaca, llama, camel, cashmere, mohair, angora, vicuna, yak, guanaco, cashgora, beaver, otter, followed or not by the word \u2018wool\u2019 or \u2018hair\u2019 hair of the following animals: alpaca, llama, camel, kashmir goat, angora goat, angora rabbit, vicuna, yak, guanaco, cashgora goat, beaver, otter 3 animal or horsehair, with or without an indication of the kind of animal (e.g. cattle hair, common goat hair, horsehair) hair of the various animals not mentioned under number 1 or 2 4 Silk fibre obtained exclusively from silk-secreting insects 5 cotton fibre obtained from the bolls of the cotton plant (Gossypium) 6 kapok fibre obtained from the inside of the kapok fruit (Ceiba pentandra) 7 flax (or linen) fibre obtained from the bast of the flax plant (Linum usitatissimum) 8 true hemp fibre obtained from the bast of hemp (Cannabis sativa) 9 Jute fibre obtained from the bast of Corchorus olitorius and Corchorus capsularis. For the purposes of this Regulation, bast fibres obtained from the following species shall be treated in the same way as jute: Hibiscus cannabinus, Hibiscus sabdariffa, Abutilon avicennae, Urena lobata, Urena sinuata 10 abaca (Manila hemp) fibre obtained from the sheathing leaf of Musa textilis 11 Alfa fibre obtained from the leaves of Stipa tenacissima 12 coir (coconut) fibre obtained from the fruit of Cocos nucifera 13 broom fibre obtained from the bast of Cytisus scoparius and/or Spartium Junceum 14 ramie fibre obtained from the bast of Boehmeria nivea and Boehmeria tenacissima 15 sisal fibre obtained from the leaves of Agave sisalana 16 sunn fibre from the bast of Crotalaria juncea 17 henequen fibre from the bast of Agave fourcroydes 18 maguey fibre from the bast of Agave cantala Table 2 Number Name Fibre description 19 acetate cellulose acetate fibre wherein less than 92 % but at least 74 % of the hydroxyl groups are acetylated 20 alginate fibre obtained from metallic salts of alginic acid 21 cupro regenerated cellulose fibre obtained by the cuprammonium process 22 modal a regenerated cellulose fibre obtained by a modified viscose process having a high breaking force and high wet modulus. The breaking force (BC) in the conditioned state and the force (BM) required to produce an elongation of 5 % in the wet state are: BC (cN) \u2265 1,3 BM (cN) \u2265 0,5 where T is the mean linear density in decitex 23 protein fibre obtained from natural protein substances regenerated and stabilised through the action of chemical agents 24 triacetate cellulose acetate fibre wherein at least 92 % of the hydroxyl groups are acetylated 25 viscose regenerated cellulose fibre obtained by the viscose process for filament and discontinuous fibre 26 acrylic fibre formed of linear macromolecules comprising at least 85 % (by mass) in the chain of the acrylonitrilic pattern 27 chlorofibre fibre formed of linear macromolecules having in their chain more than 50 % by mass of chlorinated vinyl or chlorinated vinylidene monomeric units 28 fluorofibre fibre formed of linear macromolecules made from fluorocarbon aliphatic monomers 29 modacrylic fibre formed of linear macromolecules having in the chain more than 50 % and less than 85 % (by mass) of the acrylonitrilic pattern 30 polyamide or nylon fibre formed from synthetic linear macromolecules having in the chain recurring amide linkages of which at least 85 % are joined to aliphatic or cycloaliphatic units 31 aramid fibre formed from synthetic linear macromolecules made up of aromatic groups joined by amide or imide linkages, of which at least 85 % are joined directly to two aromatic rings and with the number of imide linkages, if present, not exceeding the number of amide linkages 32 polyimide fibre formed from synthetic linear macromolecules having in the chain recurring imide units 33 lyocell a regenerated cellulose fibre obtained by dissolution, and an organic solvent (mixture of organic chemicals and water) spinning process, without formation of derivatives 34 polylactide fibre formed of linear macromolecules having in the chain at least 85 % (by mass) of lactic acid ester units derived from naturally occurring sugars, and which has a melting temperature of at least 135 \u00b0C 35 polyester fibre formed of linear macromolecules comprising at least 85 % (by mass) in the chain of an ester of a diol and terephthalic acid 36 polyethylene fibre formed of un-substituted aliphatic saturated hydrocarbon linear macromolecules 37 polypropylene fibre formed of an aliphatic saturated hydrocarbon linear macromolecule where one carbon atom in two carries a methyl side chain in an isotactic disposition and without further substitution 38 polycarbamide fibre formed of linear macromolecules having in the chain the recurring ureylene (NH-CO-NH) functional group 39 polyurethane fibre formed of linear macromolecules composed of chains with the recurring urethane functional group 40 vinylal fibre formed of linear macromolecules whose chain is constituted by poly(vinyl alcohol) with differing levels of acetalisation 41 trivinyl fibre formed of acrylonitrile terpolymer, a chlorinated vinyl monomer and a third vinyl monomer, none of which represents as much as 50 % of the total mass 42 elastodiene elastofibre composed of natural or synthetic polyisoprene, or composed of one or more dienes polymerised with or without one or more vinyl monomers, and which, when stretched to three times its original length and released, recovers rapidly and substantially to its initial length 43 elastane elastofibre composed of at least 85 % (by mass) of a segmented polyurethane, and which, when stretched to three times its original length and released, recovers rapidly and substantially to its initial length 44 glass fibre fibre made of glass 45 elastomultiester fibre formed by interaction of two or more chemically distinct linear macromolecules in two or more distinct phases (of which none exceeds 85 % by mass) which contains ester groups as the dominant functional unit (at least 85 %) and which, after suitable treatment when stretched to one and half times its original length and released, recovers rapidly and substantially to its initial length 46 elastolefin fibre composed of at least 95 % (by mass) of macromolecules partially cross-linked, made up from ethylene and at least one other olefin and which, when stretched to one and a half times its original length and released, recovers rapidly and substantially to its initial length 47 melamine fibre formed of at least 85 % by mass of cross-linked macromolecules made up of melamine derivatives 48 name corresponding to the material of which the fibres are composed, e.g. metal (metallic, metallised), asbestos, paper, followed or not by the word \u2018yarn\u2019 or \u2018fibre\u2019 fibres obtained from miscellaneous or new materials not listed above ANNEX II Minimum requirements regarding a technical file to be included in the application for a new textile fibre name (referred to in Article 6) A technical file to be attached to an application for the inclusion of a new textile fibre name in the list set out in Annex I, as provided for in Article 6, shall contain at least the following information: (1) Proposed name of the textile fibre: The name proposed shall be related to the chemical composition and shall provide information about the characteristics of the fibre, if appropriate. The name proposed shall be free of any intellectual property rights and shall not be linked to the manufacturer. (2) Proposed definition of the textile fibre: The characteristics mentioned in the definition of the new textile fibre, such as elasticity, shall be verifiable via testing methods to be provided with the technical file along with the experimental results of analyses. (3) Identification of the textile fibre: chemical formula, differences from existing textile fibres, together with, where relevant, detailed data such as melting point, density, refractive index, burning behaviour and FTIR spectrum. (4) Proposed agreed allowance to be used in the calculation of fibre composition. (5) Sufficiently developed identification and quantification methods, including experimental data: The applicant shall evaluate the possibility to use the methods listed in Annex VIII or the harmonised standards to be introduced in that Annex to analyse the most expected commercial mixtures of the new textile fibre with other textile fibres and shall propose at least one of those methods. For those methods or harmonised standards where the textile fibre can be considered as an insoluble component, the applicant shall evaluate the mass correction factors of the new textile fibre. All the experimental data shall be submitted with the application. If methods listed in this Regulation are not suitable, the applicant shall provide adequate reasoning and propose a new method. The application shall contain all the experimental data for the methods proposed. Data on the accuracy, robustness and repeatability of the methods shall be provided with the file. (6) Available scientific information concerning possible allergic reactions or other adverse effects of the new textile fibre on human health, including results of tests conducted to that effect in compliance with relevant Union legislation. (7) Additional information to support the application: production process, consumer relevance. The manufacturer or any person acting on the manufacturer\u2019s behalf shall provide representative samples of the new pure textile fibre and the relevant textile fibre mixtures necessary to conduct the validation of the proposed identification and quantification methods. The Commission may request additional samples of relevant fibre mixtures from the manufacturer or the person acting on the manufacturer\u2019s behalf. ANNEX III Names referred to in Article 8(1) \u2014 in Bulgarian: \u2018\u043d\u0435\u043e\u0431\u0440\u0430\u0431\u043e\u0442\u0435\u043d\u0430 \u0432\u044a\u043b\u043d\u0430\u2019 \u2014 in Spanish: \u2018lana virgen\u2019 or \u2018lana de esquilado\u2019 \u2014 in Czech: \u2018st\u0159i\u017en\u00ed vlna\u2019 \u2014 in Danish: \u2018ren, ny uld\u2019 \u2014 in German: \u2018Schurwolle\u2019 \u2014 in Estonian: \u2018uus vill\u2019 \u2014 in Greek: \u2018\u03c0\u03b1\u03c1\u03b8\u03ad\u03bd\u03bf \u03bc\u03b1\u03bb\u03bb\u03af\u2019 \u2014 in English: \u2018fleece wool\u2019 or \u2018virgin wool\u2019 \u2014 in French: \u2018laine vierge\u2019 or \u2018laine de tonte\u2019 \u2014 in Irish: \u2018olann lomra\u2019 \u2014 in Italian: \u2018lana vergine\u2019 or \u2018lana di tosa\u2019 \u2014 in Latvian: \u2018pirmlietojuma vilna\u2019 or \u2018cirpt\u0101 vilna\u2019 \u2014 in Lithuanian: \u2018nat\u016bralioji vilna\u2019 \u2014 in Hungarian: \u2018\u00e9l\u0151gyapj\u00fa\u2019 \u2014 in Maltese: \u2018suf ver\u0121ni\u2019 \u2014 in Dutch: \u2018scheerwol\u2019 \u2014 in Polish: \u2018\u017cywa we\u0142na\u2019 \u2014 in Portuguese: \u2018l\u00e3 virgem\u2019 \u2014 in Romanian: \u2018l\u00e2n\u0103 virgin\u0103\u2019 \u2014 in Slovak: \u2018stri\u017en\u00e1 vlna\u2019 \u2014 in Slovene: \u2018runska volna\u2019 \u2014 in Finnish: \u2018uusi villa\u2019 \u2014 in Swedish: \u2018ny ull\u2019 ANNEX IV Special provisions for the labelling and marking of certain textile products (referred to in Article 13) Products Labelling and marking provisions 1. The following corsetry products: The fibre composition shall be indicated on the label and marking by stating the composition of the whole product or, either inclusively or separately, that of the components listed respectively: (a) Brassi\u00e8res the outside and the inside fabric of the surface of the cups and back (b) Corsets and girdles the front, the rear and side panels (c) Corselets the outside and inside fabric of the surface of cups, the front and rear stiffening panels and the side panels 2. Other corsetry products not listed above The fibre composition shall be indicated by stating the composition of the whole product or, either inclusively or separately, the composition of the various components of the products. Such labelling shall not be compulsory for components representing less than 10 % of the total weight of the product 3. All corsetry products The separate labelling and marking of the various parts of corsetry products shall be carried out in such a way that the consumer can easily understand to which part of the product the information on the label or marking refers 4. Etch-printed textiles The fibre composition shall be given for the product as a whole and may be indicated by stating, separately, the composition of the base fabric and that of the etched parts. Those components shall be mentioned by name 5. Embroidered textiles The fibre composition shall be given for the product as a whole and may be indicated by stating, separately, the composition of the base fabric and that of the embroidery yarn. Those components shall be mentioned by name. Such labelling or marking is compulsory only for the embroidered parts which amount to at least 10 % of the surface area of the product 6. Yarns consisting of a core and a cover made up of different fibres and made available on the market as such to the consumer The fibre composition shall be given for the product as a whole and may be indicated by stating the composition of the core and the cover separately. Those components shall be mentioned by name 7. Velvet and plush textiles, or textiles resembling velvet or plush The fibre composition shall be given for the whole product and, where the product comprises a distinct backing and a use-surface composed of different fibres, may be stated separately for those components. Those components shall be mentioned by name 8. Floor coverings and carpets of which the backing and the use-surface are composed of different fibres The fibre composition may be stated for the use-surface alone. The use-surface must be mentioned by name ANNEX V Textile products for which labelling or marking is not mandatory (referred to in Article 17(2)) 1. Sleeve-supporting armbands 2. Watch straps of textile materials 3. Labels and badges 4. Stuffed pan-holders of textile materials 5. Coffee cosy covers 6. Tea cosy covers 7. Sleeve protectors 8. Muffs other than in pile fabric 9. Artificial flowers 10. Pin cushions 11. Painted canvas 12. Textile products for base and underlying fabrics and stiffenings 13. Old made-up textile products, where explicitly stated to be such 14. Gaiters 15. Packaging, not new and sold as such 16. Fancy goods and saddlery, of textile materials 17. Travel goods of textile materials 18. Hand-embroidered tapestries, finished or unfinished, and materials for their production, including embroidery yarns, sold separately from the canvas and specially presented for use in such tapestries 19. Slide fasteners 20. Buttons and buckles covered with textile materials 21. Book covers of textile materials 22. Toys 23. Textile parts of footwear 24. Table mats having several components and a surface area of not more than 500 cm2 25. Oven gloves and cloths 26. Egg cosy covers 27. Make-up cases 28. Tobacco pouches of textile fabric 29. Spectacle, cigarette and cigar, lighter and comb cases of textile fabric 30. Covers for mobile telephones and portable media players with a surface of not more than 160 cm2 31. Protective requisites for sports with the exception of gloves 32. Toilet cases 33. Shoe-cleaning cases 34. Funeral products 35. Disposable products, with the exception of wadding 36. Textile products subject to the rules of the European Pharmacopoeia and covered by a reference to those rules, non-disposable bandages for medical and orthopaedic use and orthopaedic textile products in general 37. Textile products including cordage, ropes and string, subject to item 12 of Annex VI, normally intended: (a) for use as equipment components in the manufacture and processing of goods; (b) for incorporation in machines, installations (e.g. for heating, air conditioning or lighting), domestic and other appliances, vehicles and other means of transport, or for their operation, maintenance or equipment, other than tarpaulin covers and textile motor vehicle accessories sold separately from the vehicle 38. Textile products for protection and safety purposes such as safety belts, parachutes, life-jackets, emergency chutes, fire-fighting devices, bulletproof waistcoats and special protective garments (e.g. protection against fire, chemical substances or other safety hazards) 39. Air-supported structures (e.g. sports halls, exhibition stands or storage facilities), provided that details of the performances and technical specifications of these products are supplied 40. Sails 41. Animal clothing 42. Flags and banners ANNEX VI Textile products for which inclusive labelling is sufficient (referred to in Article 17(3)) 1. Floorcloths 2. Cleaning cloths 3. Edgings and trimmings 4. Passementerie 5. Belts 6. Braces 7. Suspenders and garters 8. Shoe and boot laces 9. Ribbons 10. Elastic 11. New packaging sold as such 12. Packing string and agricultural twine; string, cordage and ropes other than those falling within item 37 of Annex V (1) 13. Table mats 14. Handkerchiefs 15. Bun nets and hair nets 16. Ties and bow ties for children 17. Bibs, washgloves and face flannels 18. Sewing, mending and embroidery yarns presented for retail sale in small quantities with a net weight of 1 gram or less 19. Tape for curtains and blinds and shutters (1) For the products falling within this item and sold in cut lengths, the inclusive labelling shall be that of the reel. The cordage and ropes falling within this item include those used in mountaineering and water sports. ANNEX VII Items not to be taken into account for the determination of fibre composition (referred to in Article 19(2)) Products Items excluded (a) All textile products (i) Non-textile parts, selvedges, labels and badges, edgings and trimmings not forming an integral part of the product, buttons and buckles covered with textile materials, accessories, decorations, non-elastic ribbons, elastic threads and bands added at specific and limited points of the product and, subject to the conditions specified in Article 10, visible, isolable fibres which are purely decorative and fibres with antistatic effect (ii) Fatty substances, binders, weightings, sizings and dressings, impregnating products, additional dyeing and printing products and other textile processing products (b) Floor coverings and carpets All components other than the use-surface (c) Upholstery fabrics Binding and filling warps and wefts which do not form part of the use-surface (d) Hangings and curtains Binding and filling warps and wefts which do not form part of the right side of the fabric (e) Socks Additional elastic yarns used in the cuff and the stiffening and reinforcement yarns of the toe and the heel (f) Tights Additional elastic yarns used in the belt and the stiffening and reinforcement yarns of the toe and the heel (g) Textile products other than those under points (b) to (f) Base or underlying fabrics, stiffenings and reinforcements, inter-linings and canvas backings, stitching and assembly threads unless they replace the warp and/or weft of the fabric, fillings not having an insulating function and, subject to Article 11(2), linings For the purposes of this provision: (i) the base or underlying material of textile products which serve as a backing for the use-surface, in particular in blankets and double fabrics, and the backings of velvet or plush fabrics and kindred products shall not be regarded as backings to be removed; (ii) \u2018stiffenings and reinforcements\u2019 mean the yarns or materials added at specific and limited points of the textile products to strengthen them or to give them stiffness or thickness ANNEX VIII Methods for the quantitative analysis of binary and ternary textile fibre mixtures (referred to in Article 19(1)) CHAPTER 1 I. Preparation of laboratory test samples and test specimens to determine the fibre composition of textile products 1. FIELD OF APPLICATION This Chapter gives procedures for obtaining laboratory test samples of a suitable size for pre-treatment for quantitative analysis (i.e. of a mass not exceeding 100 g) from laboratory bulk samples, and for selecting test specimens from the laboratory test samples that have been pre-treated to remove non-fibrous matter (1). 2. DEFINITIONS 2.1. Bulk source The quantity of material which is assessed on the basis of one series of test results. This may comprise, for example, all the material in one delivery of cloth; all the cloth woven from a particular beam; a consignment of yarn, a bale or a group of bales of raw fibre. 2.2. Laboratory bulk sample The portion of the bulk source taken to be representative of the whole, and which is available to the laboratory. The size and nature of the laboratory bulk sample shall be sufficient to adequately overcome the variability of the bulk source and to facilitate ease of handling in the laboratory (2). 2.3. Laboratory test sample That portion of the laboratory bulk sample that is subjected to pre-treatment to remove non-fibrous matter, and from which test specimens are taken. The size and nature of the laboratory test sample shall be sufficient to overcome adequately the variability of the laboratory bulk sample (3). 2.4. Test specimen The portion of material required to give an individual test result, and selected from the laboratory test sample. 3. PRINCIPLE The laboratory test sample is selected so that it is representative of the laboratory bulk sample. The test specimens are taken from the laboratory test sample in such a way that each of them is representative of the laboratory test sample. 4. SAMPLING FROM LOOSE FIBRES 4.1. Unorientated fibres Obtain the laboratory test sample by selecting tufts at random from the laboratory bulk sample. Mix thoroughly the whole of the laboratory test sample by means of a laboratory carder (4). Subject the web or mixture, including loose fibres and fibres adhering to the equipment used for mixing, to pre-treatment. Then select test specimens, in proportion to the respective masses, from the web or mixture, from the loose fibres and from the fibres adhering to the equipment. If the card web remains intact after pre-treatment, select the test specimens in the manner described in 4.2. If the card web is disturbed by the pre-treatment, select each test specimen by removing at random at least 16 small tufts of suitable and approximately equal size and then combine them. 4.2. Orientated fibres (cards, webs, slivers, rovings) From randomly selected parts of the laboratory bulk sample cut not less than 10 cross-sections each of mass approximately 1 g. Subject the laboratory test sample so formed to the pre-treatment. Recombine the cross-sections by laying them side by side and obtain the test specimen by cutting through them so as to take a portion of each of the 10 lengths. 5. SAMPLING YARN 5.1. Yarn in packages or in banks Sample all the packages in the bulk laboratory sample. Withdraw the appropriate continuous equal lengths from each package either by winding skeins of the same number of turns on a wrap-reel (5), or by some other means. Unite the lengths side by side either as a single skein or as a tow to form the laboratory test sample, ensuring that there are equal lengths from each package in the skein or tow. Subject the laboratory test sample to the pre-treatment. Take test specimens from the laboratory test sample by cutting a bunch of threads of equal length from the skein or tow, taking care to see that the bunch contains all the threads in the sample. If the tex of the yarn is t and the number of packages selected from the laboratory bulk sample is n, then to obtain a test sample of 10 g, the length of yarn to be withdrawn from each package is 106/nt cm. If nt is high, i.e. more than 2 000, wind a heavier skein and cut it across in two places to make a tow of suitable mass. The ends of any sample in the form of a tow shall be securely tied before pre-treatment and test specimens taken from a place remote from the tie bands. 5.2. Yarn on warp Take the laboratory test sample by cutting a length from the end of the warp, not less than 20 cm long and comprising all the yarns in the warp except the selvedge yarns, which are rejected. Tie the bunch of threads together near one end. If the sample is too large for pre-treatment as a whole divide it into two or more portions, each tied together for pre-treatment, and reunite the portions after each has been pre-treated separately. Take a test specimen by cutting a suitable length from the laboratory test sample from the end remote from the tie band, and comprising all the threads in the warp. For warp of N threads of tex t, the length of a specimen of mass 1 g is 105/Nt cm. 6. SAMPLING FABRIC 6.1. From a laboratory bulk sample consisting of a single cutting representative of the cloth Cut a diagonal strip from one corner to the other and remove the selvedges. This strip is the laboratory test sample. To obtain a laboratory test sample of x g, the strip area shall be x104/G cm2, where G is the mass of the cloth in g/m2. Subject the laboratory test sample to the pre-treatment and then cut the strip transversely into four equal lengths and superimpose them. Take test specimens from any part of the layered material by cutting through all the layers so that each specimen contains an equal length of each layer. If the fabric has a woven design, make the width of the laboratory test sample, measured parallel to the warp direction, not less than one warp repeat of the design. If, with this condition satisfied, the laboratory test sample is too large to be treated as a whole, cut it into equal parts, pre-treat them separately, and superimpose these parts before selection of the test specimen, taking care that corresponding parts of the design do not coincide. 6.2. From a laboratory bulk sample consisting of several cuttings Treat each cutting as described in 6.1, and give each result separately. 7. SAMPLING MADE-UP AND FINISHED PRODUCTS The bulk laboratory sample is normally a complete made-up or finished product or representative fraction of one. Where appropriate determine the percentage of the various parts of the product not having the same fibre content, in order to check compliance with Article 11. Select a laboratory test sample representative of the part of the made-up or finished product, whose composition must be shown by the label. If the product has several labels, select laboratory test samples representative of each part corresponding to a given label. If the product whose composition is to be determined is not uniform, it may be necessary to select laboratory test samples from each of the parts of the product and to determine the relative proportions of the various parts in relation to the whole product in question. Then calculate the percentages taking into account the relative proportions of the sampled parts. Subject the laboratory test samples to the pre-treatment. Then select test specimens representative of the pre-treated laboratory test samples. II. Introduction to the methods for the quantitative analysis of textile fibre mixtures Methods for the quantitative analysis of fibre mixtures are based on two main processes, the manual separation and the chemical separation of fibres. The method of manual separation shall be used whenever possible since it generally gives more accurate results than the chemical method. It can be used for all textiles whose component fibres do not form an intimate mixture, as for example in the case of yarns composed of several elements each of which is made up of only one type of fibre, or fabrics in which the fibre of the warp is of a different kind to that of the weft, or knitted fabrics capable of being unravelled made up of yarns of different types. In general, the methods of chemical quantitative analysis are based on the selective solution of the individual components. After the removal of a component the insoluble residue is weighed, and the proportion of the soluble component is calculated from the loss in mass. This first part of the Annex gives the information common to the analyses by this method of all fibre mixtures dealt with in the Annex, whatever their composition. It shall thus be used in conjunction with the succeeding individual sections of the Annex, which contain the detailed procedures applicable to particular fibre mixtures. Occasionally, an analysis is based on a principle other than selective solution; in such cases full details are given in the appropriate section. Mixtures of fibres during processing and, to a lesser extent, finished textiles may contain non-fibrous matter, such as fats, waxes or dressings, or water-soluble matter, either occurring naturally or added to facilitate processing. Non-fibrous matter must be removed before analysis. For this reason a method for removing oils, fats, waxes and water-soluble matter is also given. In addition, textiles may contain resins or other matter added to confer special properties. Such matter, including dyestuffs in exceptional cases, may interfere with the action of the reagent on the soluble component and/or it may be partially or completely removed by the reagent. This type of added matter may thus cause errors and shall be removed before the sample is analysed. If it is impossible to remove such added matter the methods for quantitative chemical analysis given in this Annex are no longer applicable. Dye in dyed fabrics is considered to be an integral part of the fibre and is not removed. Analyses are conducted on the basis of dry mass and a procedure is given for determining dry mass. The result is obtained by applying to the dry mass of each fibre the agreed allowances listed in Annex IX. Before proceeding with any analysis, all the fibres present in the mixture shall have been identified. In some methods, the insoluble component of a mixture may be partially dissolved in the reagent used to dissolve the soluble component(s). Where possible, reagents have been chosen that have little or no effect on the insoluble fibres. If loss in mass is known to occur during the analysis, the result shall be corrected; correction factors for this purpose are given. These factors have been determined in several laboratories by treating, with the appropriate reagent as specified in the method of analysis, fibres cleaned by the pre treatment. These correction factors apply only to undegraded fibres and different correction factors may be necessary if the fibres have been degraded before or during processing. The procedures given apply to single determinations. At least two determinations on separate test specimens shall be made, both in the case of manual separation and in the case of chemical separation. For confirmation, unless technically impossible, it is recommended to use alternative procedures whereby the constituent that was the residue in the standard method is dissolved out first. CHAPTER 2 METHODS FOR QUANTITATIVE ANALYSIS OF CERTAIN BINARY TEXTILE FIBRE MIXTURES I. General information common to the methods given for the quantitative chemical analysis of textile fibre mixtures I.1. FIELD OF APPLICATION The field of application for each method specifies to which fibres the method is applicable. I.2. PRINCIPLE After the identification of the components of a mixture, the non-fibrous material is removed by suitable pre-treatment and then one of the components, usually by selective solution (6). The insoluble residue is weighed and the proportion of soluble component calculated from the loss in mass. Except where this presents technical difficulties, it is preferable to dissolve the fibre present in the greater proportion, thus obtaining the fibre present in the smaller proportion as residue. I.3. MATERIALS AND EQUIPMENT I.3.1. Apparatus I.3.1.1. Filter crucibles and weighing bottles large enough to contain such crucibles, or any other apparatus giving identical results. I.3.1.2. Vacuum flask. I.3.1.3. Desiccator containing self-indicating silica gel. I.3.1.4. Ventilated oven for drying specimens at 105 \u00b1 3 \u00b0C. I.3.1.5. Analytical balance, accurate to 0,0002 g. I.3.1.6. Soxhlet extractor or other apparatus giving identical results. I.3.2. Reagents. I.3.2.1. Light petroleum, redistilled, boiling range 40 to 60 \u00b0C. I.3.2.2. Other reagents are specified in the appropriate section of each method. I.3.2.3. Distilled or deionised water. I.3.2.4. Acetone. I.3.2.5. Orthophosphoric acid. I.3.2.6. Urea. I.3.2.7. Sodium bicarbonate. All reagents used shall be chemically pure. I.4. CONDITIONING AND TESTING ATMOSPHERE Because dry masses are determined, it is unnecessary to condition the specimen or to conduct analyses in a conditioned atmosphere. I.5. LABORATORY TEST SAMPLE Take a laboratory test sample that is representative of the laboratory bulk sample and sufficient to provide all the specimens, each of at least 1 g, that are required. I.6. PRE-TREATMENT OF LABORATORY TEST SAMPLE (7) Where a substance not to be taken into account in the percentage calculations (see Article 19) is present, it shall first be removed by a suitable method that does not affect any of the fibre constituents. For this purpose, non-fibrous matter which can be extracted with light petroleum and water is removed by treating the laboratory test sample in a Soxhlet extractor with light petroleum for 1 hour at a minimum rate of six cycles per hour. Allow the light petroleum to evaporate from the sample, which is then extracted by direct treatment consisting in soaking the laboratory test sample in water at room temperature for 1 hour and then soaking it in water at 65 \u00b1 5 \u00b0C for a further hour, agitating the liquor from time to time. Use a liquor-laboratory test sample ratio of 100:1. Remove the excess water from the sample by squeezing, suction or centrifuging and then allow the sample to become air-dry. In the case of elastolefin or fibre mixtures containing elastolefin and other fibres (wool, animal hair, silk, cotton, flax (or linen) true hemp, jute, abaca, alfa, coir, broom, ramie, sisal, cupro, modal, protein, viscose, acrylic, polyamide or nylon, polyester, elastomultiester) the procedure just described shall be slightly modified, in that light petroleum ether shall be replaced by acetone. In the case of binary fibre mixtures containing elastolefin and acetate the following procedure shall apply as pre-treatment. Extract the laboratory test sample for 10 minutes at 80 \u00b0C with a solution containing 25 g/l of 50 % orthophosphoric acid and 50 g/l of urea. Use a liquor-laboratory test sample ratio of 100:1. Wash laboratory test sample in water, then drain and wash it in a 0,1 % sodium bicarbonate solution, finally wash it carefully in water. Where non-fibrous matter cannot be extracted with light petroleum and water, it shall be removed by substituting for the water method described above a suitable method that does not substantially alter any of the fibre constituents. However, for some unbleached, natural vegetable fibres (e.g. jute, coir) it is to be noted that normal pre-treatment with light petroleum and water does not remove all the natural non-fibrous substances; nevertheless additional pre-treatment is not applied unless the sample contains finishes insoluble in both light petroleum and water. Analysis reports shall include full details of the methods of pre-treatment used. I.7. TEST PROCEDURE I.7.1. General instructions I.7.1.1. Drying Conduct all drying operations for not less than 4 hours and not more than 16 hours at 105 \u00b1 3 \u00b0C in a ventilated oven with the oven door closed throughout. If the drying period is less than 14 hours, the specimen must be weighed to check that its mass has become constant. The mass may be considered to have become constant if, after a further drying period of 60 minutes, its variation is less than 0,05 %. Avoid handling crucibles and weighing bottles, specimens or residues with bare hands during the drying, cooling and weighing operations. Dry specimens in a weighing bottle with its cover beside it. After drying, stopper the weighing bottle before removing it from the oven, and transfer it quickly to the desiccator. Dry the filter crucible in a weighing bottle with its cover beside it in the oven. After drying, close the weighing bottle and transfer it quickly to the desiccator. Where apparatus other than a filter crucible is used, drying operations in the oven shall be conducted in such a way as to enable the dry mass of the fibres to be determined without loss. I.7.1.2. Cooling Conduct all cooling operations in the desiccator, the latter placed beside the balance, until complete cooling of the weighing bottles is attained, and in any case for not less than 2 hours. I.7.1.3. Weighing After cooling, complete the weighing of the weighing bottle within 2 minutes of its removal from the desiccator. Weigh to an accuracy of 0,0002 g. I.7.2. Procedure Take from the pre-treated laboratory test sample a test specimen weighing at least 1 g. Cut yarn or cloth into lengths of about 10 mm, dissected as much as possible. Dry the specimen in a weighing bottle, cool it in the desiccator and weigh it. Transfer the specimen to the glass vessel specified in the appropriate section of the relevant Union method, reweigh the weighing bottle immediately and obtain the dry mass of the specimen by difference. Complete the test as specified in the appropriate section of the applicable method. Examine the residue microscopically to check that the treatment has in fact completely removed the soluble fibre. I.8. CALCULATION AND EXPRESSION OF RESULTS Express the mass of the insoluble component as a percentage of the total mass of fibre in the mixture. The percentage of soluble component is obtained by difference. Calculate the results on the basis of clean, dry mass, adjusted by (a) the agreed allowances and (b) the correction factors necessary to take account of loss of matter during pre-treatment and analysis. Calculations shall be made by applying the formula given in I.8.2. I.8.1. Calculation of percentage of insoluble component on clean, dry mass basis, disregarding loss of fibre mass during pre-treatment: where P1% is the percentage of clean, dry insoluble component, m is the dry mass of the test specimen after pre-treatment, r is the dry mass of the residue, d is the correction factor for loss in mass of the insoluble component in the reagent during the analysis. Suitable values for \u2018d\u2019 are given in the relevant section of each method. Of course, these values for \u2018d\u2019 are the normal values applicable to chemically undegraded fibres. I.8.2. Calculation of percentage of insoluble component on clean, dry mass basis, with adjustment by conventional factors and, where appropriate, correction factors for loss of mass during pre-treatment: where P1A% is the percentage of insoluble component adjusted by agreed allowances and for loss in mass during pre-treatment, P1 is the percentage of clean dry insoluble component as calculated from the formula shown in I.8.1, a1 is the agreed allowance for the insoluble component (see Annex IX), a2 is the agreed allowance for the soluble component (see Annex IX), b1 is the percentage loss of insoluble component caused by pre-treatment, b2 is the percentage loss of soluble component caused by pre-treatment. The percentage of the second component is P2A % = 100 \u2013 P1A %. Where a special pre-treatment has been used, the values of b1 and b2 shall be determined, if possible, by submitting each of the pure fibre constituents to the pre-treatment applied in the analysis. Pure fibres are those free from all non-fibrous material except that which they normally contain (either naturally or because of the manufacturing process), in the state (unbleached, bleached) in which they are found in the material to be analysed. Where no clean separate constituent fibres used in the manufacture of the material to be analysed are available, average values of b1 and b2 as obtained from tests performed on clean fibres similar to those in the mixture under examination, shall be used. If normal pre-treatment by extraction with light petroleum and water is applied, correction factors b1 and b2 may generally be ignored, except in the case of unbleached cotton, unbleached flax (or linen) and unbleached hemp, where the loss due to the pre-treatment is conventionally taken as 4 %, and in the case of polypropylene, where it is taken as 1 %. In the case of other fibres, losses due to the pre-treatment are conventionally disregarded in calculations. II. Method of quantitative analysis by manual separation II.1. FIELD OF APPLICATION This method is applicable to textile fibres of all types provided they do not form an intimate mixture and that it is possible to separate them by hand. II.2. PRINCIPLE After identification of the constituents of the textile, the non-fibrous material is removed by suitable pre-treatment and then the fibres are separated by hand, dried and weighed in order to calculate the proportion of each fibre in the mixture. II.3. APPARATUS II.3.1. Weighing bottle or any other apparatus giving identical results. II.3.2. Desiccator containing self-indicating silica gel. II.3.3. Ventilated oven for drying specimens at 105 \u00b1 3 \u00b0C. II.3.4. Analytical balance, accurate to 0,0002 g. II.3.5. Soxhlet extractor, or other apparatus giving an identical result. II.3.6. Needle. II.3.7. Twist tester or similar apparatus. II.4. REAGENTS II.4.1. Light petroleum, redistilled, boiling range 40 to 60 \u00b0C. II.4.2. Distilled or deionised water. II.4.3. Acetone. II.4.4. Orthophosphoric acid. II.4.5. Urea. II.4.6. Sodium bicarbonate. All reagents used shall be chemically pure. II.5. CONDITIONING AND TESTING ATMOSPHERE See I.4. II.6. LABORATORY TEST SAMPLE See I.5. II.7. PRE-TREATMENT OF LABORATORY TEST SAMPLE See I.6. II.8. PROCEDURE II.8.1. Analysis of yarn Select from the pre-treatment laboratory test sample a specimen of mass not less than 1 g. For a very fine yarn, the analysis may be made on a minimum length of 30 m, whatever its mass. Cut the yarn into pieces of a suitable length and separate the fibre types by means of a needle and, if necessary, a twist tester. The fibre types so obtained are placed in pre-weighed weighing bottles and dried at 105 \u00b1 3 \u00b0C until a constant mass is obtained, as described in I.7.1 and I.7.2. II.8.2. Analysis of cloth Select from the pre-treated laboratory test sample, well away from all selvedges, a specimen of mass not less than 1 g, with edges carefully trimmed to avoid fraying and running parallel with weft or warp yarns, or in the case of knitted fabrics in the line of wales and courses. Separate the different fibre types, collect them in pre-weighed weighing bottles and proceed as described in II.8.1. II.9. CALCULATION AND EXPRESSION OF RESULTS Express the mass of each fibre constituent as a percentage of the total mass of the fibres in the mixture. Calculate the results on the basis of clean, dry mass, adjusted by (a) the agreed allowances and (b) the correction factors necessary to take account of loss of matter during pre-treatment. II.9.1. Calculation of percentage masses of clean, dry fibre, disregarding loss of fibre mass during pre-treatment: P1% is the percentage of the first clean, dry component, m1 is the clean, dry mass of the first component, m2 is the clean, dry mass of the second component. II.9.2. For calculation of the percentage of each component with adjustment by agreed allowances and, where appropriate, by correction factors for loss of matter during pre-treatment, see I.8.2. III.1. PRECISION OF THE METHODS The precision indicated in individual methods relates to the reproducibility. The reproducibility refers to the reliability, i.e. the closeness of agreement between experimental values obtained by operators in different laboratories or at different times using the same method and obtaining individual results on specimens of an identical consistent mixture. The reproducibility is expressed by confidence limits of the results for a confidence level of 95 %. Therefore, the difference between two results in a series of analyses made in different laboratories would, given a normal and correct application of the method to an identical and consistent mixture, exceed the confidence limit only in five cases out of 100. III.2. TEST REPORT III.2.1. State that the analysis was conducted in accordance with this method. III.2.2. Give details of any special pre-treatment (see I.6). III.2.3. Give the individual results and the arithmetic mean, each to an accuracy of 0,1. IV. Special methods Summary Table Method Field of application Reagent/Description Soluble component Insoluble component 1. Acetate Certain other fibres Acetone 2. Certain protein fibres Certain other fibres Hypochlorite 3. Viscose, cupro or certain types of modal Certain other fibres Formic acid and zinc chloride 4. Polyamide or nylon Certain other fibres Formic acid, 80 % m/m 5. Acetate Certain other fibres Benzyl alcohol 6. Triacetate or polylactide Certain other fibres Dichloromethane 7. Certain cellulose fibres Certain other fibres Sulphuric acid, 75 % m/m 8. Acrylics, certain modacrylics or certain chlorofibres Certain other fibres Dimethylformamide 9. Certain chlorofibres Certain other fibres Carbon disulphide/acetone, 55,5/44,5 % v/v 10. Acetate Certain other fibres Glacial acetic acid 11. Silk Certain other fibres Sulphuric acid, 75 % m/m 12. Jute Certain animal fibres Nitrogen content method 13. Polypropylene Certain other fibres Xylene 14. Certain other fibres Chlorofibres (homopolymers of vinyl chloride), elastolefin or melamine Concentrated sulphuric acid 15. Chlorofibres, certain modacrylics, certain elastanes, acetates, triacetates Certain other fibres Cyclohexanone 16. Melamine Cotton or aramid Hot formic acid, 90 % m/m METHOD No 1 ACETATE AND CERTAIN OTHER FIBRES (Acetone method) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. acetate (19) with 2. wool (1), animal hair (2 and 3), silk (4), cotton (5), flax (or linen) (7), true hemp (8), jute (9), abaca (10), alfa (11), coir (12), broom (13), ramie (14), sisal (15), cupro (21), modal (22), protein (23), viscose (25), acrylic (26), polyamide or nylon (30), polyester (35) elastomultiester (45), elastolefin (46) and melamine (47). In no circumstances is the method applicable to acetate fibres which have been deacetylated on the surface. 2. PRINCIPLE The acetate is dissolved out from a known dry mass of the mixture, with acetone. The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of dry acetate is found by difference. 3. APPARATUS AND REAGENTS (additional to those specified in the general instructions) 3.1. Apparatus Glass-stoppered conical flasks of at least 200 ml capacity. 3.2. Reagent Acetone. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: To the test specimen contained in a glass-stoppered conical flask of at least 200 ml capacity, add 100 ml of acetone per gram of test specimen, shake the flask, stand it for 30 minutes at room temperature, stirring from time to time, and then decant the liquid through the weighed filter crucible. Repeat the treatment twice more (making three extractions in all), but for periods of 15 minutes only, so that the total time of treatment in acetone is 1 hour. Transfer the residue to the filter crucible. Wash the residue in the filter crucible with acetone and drain with suction. Refill the crucible with acetone and allow to drain under gravity. Finally, drain the crucible with suction, dry the crucible and residue, and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except for melamine, for which \u2018d\u2019 = 1,01. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 2 CERTAIN PROTEIN FIBRES AND CERTAIN OTHER FIBRES (Method using hypochlorite) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. certain protein fibres, namely: wool (1), animal hair (2 and 3), silk (4), protein (23) with 2. cotton (5), cupro (21), modal (22), viscose (25), acrylic (26), chlorofibres (27), polyamide or nylon (30), polyester (35), polypropylene (37), elastane (43), glass fibre (44), elastomultiester (45), elastolefin (46) and melamine (47). If different protein fibres are present, the method gives the total of their amounts but not their individual quantities. 2. PRINCIPLE The protein fibre is dissolved out from a known dry mass of the mixture, with a hypochlorite solution. The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of dry protein fibre is found by difference. Either lithium hypochlorite or sodium hypochlorite can be used for the preparation of the hypochlorite solution. Lithium hypochlorite is recommended in cases involving a small number of analyses or for analyses conducted at fairly lengthy intervals. This is because the percentage of hypochlorite in solid lithium hypochlorite \u2014 unlike that in sodium hypochlorite \u2014 is virtually constant. If the percentage of hypochlorite is known, hypochlorite content need not be checked iodometrically for each analysis, since a constant weighed portion of lithium hypochlorite can be employed. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Erlenmeyer flask with ground-glass stopper, 250 ml. (b) Thermostat, adjustable to 20 \u00b1 2 \u00b0C. 3.2. Reagents (a) Hypochlorite reagent (i) Lithium hypochlorite solution This consists of a freshly prepared solution containing 35 \u00b1 2 g/l of active chlorine (approximately 1 M), to which 5 \u00b1 0,5 g/l of previously dissolved sodium hydroxide is added. To prepare, dissolve 100 grams of lithium hypochlorite containing 35 % active chlorine (or 115 grams containing 30 % active chlorine) in approximately 700 ml of distilled water, add 5 grams of sodium hydroxide dissolved in approximately 200 ml of distilled water and make up to 1 litre with distilled water. The solution which has been freshly prepared need not be checked iodometrically. (ii) Sodium hypochlorite solution This consists of a freshly prepared solution containing 35 \u00b1 2 g/l of active chlorine (approximately 1 M) to which 5 \u00b1 0,5 g/l of previously dissolved sodium hydroxide is added. Check the active chlorine content of the solution iodometrically before each analysis. (b) Acetic acid, dilute solution Dilute 5 ml of glacial acetic acid to 1 litre with water. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: mix approximately 1 gram of the test specimen with approximately 100 ml of the hypochlorite solution (lithium or sodium hypochlorite) in the 250 ml flask and agitate thoroughly in order to wet out the test specimen. Then heat the flask for 40 minutes in a thermostat at 20 \u00b0C and agitate continuously, or at least at regular intervals. Since the dissolution of the wool proceeds exothermically, the reaction heat of this method must be distributed and removed. Otherwise, considerable errors may be caused by the incipient dissolution of the non-soluble fibres. After 40 minutes, filter the flask contents through a weighed glass-filter crucible and transfer any residual fibres into the filter crucible by rinsing the flask with a little hypochlorite reagent. Drain the crucible with suction and wash the residue successively with water, dilute acetic acid, and finally water, draining the crucible with suction after each addition. Do not apply suction until each washing liquor has drained under gravity. Finally, drain the crucible with suction, dry the crucible with the residue, and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except for cotton, viscose, modal and melamine for which \u2018d\u2019 = 1,01, and unbleached cotton, for which \u2018d\u2019 = 1,03. 6. PRECISION On homogeneous mixtures of textile materials, the confidence limits for results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 3 VISCOSE, CUPRO OR CERTAIN TYPES OF MODAL AND CERTAIN OTHER FIBRES (Method using formic acid and zinc chloride) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. viscose (25) or cupro (21), including certain types of modal fibre (22) with 2. cotton (5), elastolefin (46) and melamine (47). If a modal fibre is found to be present, a preliminary test shall be carried out to see whether it is soluble in the reagent. This method is not applicable to mixtures in which the cotton has suffered extensive chemical degradation nor when the viscose or cupro is rendered incompletely soluble by the presence of certain dyes or finishes that cannot be removed completely. 2. PRINCIPLE The viscose, cupro or modal fibre is dissolved from a known dry mass of the mixture, with a reagent consisting of formic acid and zinc chloride. The residue is collected, washed, dried and weighed; its corrected mass is expressed as a percentage of the dry mass of the mixture. The percentage of dry viscose, cupro or modal fibre is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flasks of at least 200 ml capacity. (b) Apparatus for maintaining flasks at 40 \u00b1 2 \u00b0C. 3.2. Reagents (a) Solution containing 20 g of fused anhydrous zinc chloride and 68 g of anhydrous formic acid made up to 100 g with water (namely 20 parts by mass of fused anhydrous zinc chloride to 80 parts by mass of 85 % m/m formic acid). Note: Attention is drawn, in this respect, to point I.3.2.2, which lays down that all reagents used shall be chemically pure; in addition, it is essential to use only fused anhydrous zinc chloride. (b) Ammonium hydroxide solution: dilute 20 ml of a concentrated ammonia solution (relative density at 20 \u00b0C: 0,880) to 1 litre with water. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: place the specimen immediately in the flask, pre-heated to 40 \u00b0C. Add 100 ml of the solution of formic acid and zinc chloride, pre-heated to 40 \u00b0C per gram of specimen. Insert the stopper and shake the flask vigorously. Keep the flask and its contents at a constant temperature of 40 \u00b0C for 2,5 hours, shaking the flask at hourly intervals. Filter the contents of the flask through the weighed filter crucible and with the help of the reagent transfer to the crucible any fibres remaining in the flask. Rinse with 20 ml of reagent pre-heated to 40 \u00b0C. Wash crucible and residue thoroughly with water at 40 \u00b0C. Rinse the fibrous residue in approximately 100 ml of cold ammonia solution (3.2(b)) ensuring that this residue remains wholly immersed in the solution for 10 minutes (8); then rinse thoroughly with cold water. Do not apply suction until each washing liquor has drained under gravity. Finally, drain the remaining liquid with suction, dry the crucible and residue, and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,02 for cotton, 1,01 for melamine and 1,00 for elastolefin. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 2 for a confidence level of 95 %. METHOD No 4 POLYAMIDE OR NYLON, AND CERTAIN OTHER FIBRES (Method using 80 % m/m formic acid) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. polyamide or nylon (30) with 2. wool (1), animal hair (2 and 3), cotton (5), cupro (21), modal (22), viscose (25), acrylic (26), chlorofibre (27), polyester (35), polypropylene (37), glass fibre (44), elastomultiester (45), elastolefin (46) and melamine (47). As mentioned above, this method is also applicable to mixtures with wool, but when the wool content exceeds 25 %, method No 2 shall be applied (dissolving wool in a solution of alkaline sodium hypochlorite or lithium hypochlorite). 2. PRINCIPLE The polyamide or nylon fibre is dissolved out from a known dry mass of the mixture, with formic acid. The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of dry polyamide or nylon is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus Glass-stoppered conical flask of at least 200 ml capacity. 3.2. Reagents (a) Formic acid (80 % m/m, relative density at 20 \u00b0C: 1,186). Dilute 880 ml of 90 % m/m formic acid (relative density at 20 \u00b0C: 1,204) to 1 litre with water. Alternatively, dilute 780 ml of 98 to 100 % m/m formic acid (relative density at 20 \u00b0C: 1,220) to 1 litre with water. The concentration is not critical within the range 77 to 83 % m/m formic acid. (b) Ammonia, dilute solution: dilute 80 ml of concentrated ammonia solution (relative density at 20 \u00b0C: 0,880) to 1 litre with water. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: to the specimen contained in the conical flask of at least 200 ml capacity, add 100 ml of formic acid per gram of specimen. Insert the stopper, shake the flask to wet out the specimen. Stand the flask for 15 minutes at room temperature, shaking it at intervals. Filter the contents of the flask through the weighed filter crucible and transfer any residual fibres to the crucible by washing out the flask with a little formic acid reagent. Drain the crucible with suction and wash the residue on the filter successively with formic acid reagent, hot water, dilute ammonia solution, and finally cold water, draining the crucible with suction after each addition. Do not apply suction until each washing liquor has drained under gravity. Finally, drain the crucible with suction, dry the crucible and residue, and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except for melamine, for which \u2018d\u2019 = 1,01. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 5 ACETATE AND CERTAIN OTHER FIBRES (Method using benzyl alcohol) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. acetate (19) with 2. triacetate (24), elastolefin (46) and melamine (47). 2. PRINCIPLE The acetate fibre is dissolved out from a known dry mass of the mixture, with benzyl alcohol at 52 \u00b1 2 \u00b0C. The residue is collected, washed, dried and weighed; its mass is expressed as a percentage of the dry mass of the mixture. The percentage of dry acetate is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flask of at least 200 ml capacity. (b) Mechanical shaker. (c) Thermostat or other apparatus for keeping the flask at a temperature of 52 \u00b1 2 \u00b0C. 3.2. Reagents (a) Benzyl alcohol. (b) Ethanol. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: To the specimen contained in the conical flask, add 100 ml of benzyl alcohol per gram of specimen. Insert the stopper, secure the flask to the shaker so that it is immersed in the water-bath, kept at 52 \u00b1 2 \u00b0C, and shake for 20 minutes at this temperature. (Instead of using a mechanical shaker, the flask may be shaken vigorously by hand). Decant the liquid through the weighed filter crucible. Add a further dose of benzyl alcohol in the flask and shake as before at 52 \u00b1 2 \u00b0C for 20 minutes. Decant the liquid through the crucible. Repeat the cycle of operations a third time. Finally pour the liquid and the residue into the crucible; wash any remaining fibres from the flask into the crucible with an extra quantity of benzyl alcohol at 52 \u00b1 2 \u00b0C. Drain the crucible thoroughly. Transfer the fibres into a flask, rinse with ethanol and after shaking manually decant through the filter crucible. Repeat this rinsing operation two or three times. Transfer the residue into the crucible and drain thoroughly. Dry the crucible and the residue and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except for melamine, for which \u2018d\u2019 = 1,01. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 6 TRIACETATES OR POLYLACTIDE AND CERTAIN OTHER FIBRES (Method using dichloromethane) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. triacetate (24) or polylactide (34) with 2. wool (1), animal hair (2 and 3), silk (4), cotton (5), cupro (21), modal (22), viscose (25), acrylic (26), polyamide or nylon (30), polyester (35), glass fibre (44), elastomultiester (45), elastolefin (46) and melamine (47). Note: Triacetate fibres which have received a finish leading to partial hydrolysis cease to be completely soluble in the reagent. In such cases, the method is not applicable. 2. PRINCIPLE The triacetate or polylactide fibres are dissolved out from a known dry mass of the mixture, with dichloromethane. The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of dry triacetate or polylactide is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus Glass-stoppered conical flask of at least 200 ml capacity. 3.2. Reagent Dichloromethane. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: To the test specimen contained in the 200 ml glass-stoppered conical flask, add 100 ml of dichloromethane per gram of the test specimen, insert the stopper, shake the flask to wet out the test specimen and stand for 30 minutes at room temperature, shaking the flask every 10 minutes. Decant the liquid through the weighed filter crucible. Add 60 ml of dichloromethane to the flask containing the residue, shake manually and filter the contents of the flask through the filter crucible. Transfer the residual fibres to the crucible by washing out the flask with a little more dichloromethane. Drain the crucible with suction to remove excess liquid, refill the crucible with dichloromethane and allow it to drain under gravity. Finally, apply suction to eliminate excess liquid, then treat the residue with boiling water to eliminate all the solvent, apply suction, dry the crucible and residue, cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except in the case of polyester, elastomultiester, elastolefin and melamine for which the value of \u2018d\u2019 is 1,01. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 7 CERTAIN CELLULOSE FIBRES AND CERTAIN OTHER FIBRES (Method using 75 % m/m sulphuric acid) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. cotton (5), flax (or linen) (7), true hemp (8), ramie (14), cupro (21), modal (22), viscose (25) with 2. polyester (35), elastomultiester (45) and elastolefin (46). 2. PRINCIPLE The cellulose fibre is dissolved out from a known dry mass of the mixture, with 75 % m/m sulphuric acid. The residue is collected, washed, dried and weighed; its mass is expressed as a percentage of the dry mass of the mixture. The proportion of dry cellulose fibre is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flask of at least 500 ml capacity. (b) Thermostat or other apparatus for maintaining the flask at 50 \u00b1 5 \u00b0C. 3.2. Reagents (a) Sulphuric acid, 75 \u00b1 2 % m/m Prepare by adding carefully, while cooling, 700 ml of sulphuric acid (relative density at 20 \u00b0C: 1,84) to 350 ml of distilled water. After the solution has cooled to room temperature, dilute to 1 litre with water. (b) Ammonia, dilute solution Dilute 80 ml of ammonia solution (relative density at 20 \u00b0C: 0,880) to 1 litre with water. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: To the specimen contained in the glass-stoppered conical flask of at least 500 ml capacity, add 200 ml of 75 % sulphuric acid per gram of specimen, insert the stopper and carefully shake the flask to wet out the specimen. Maintain the flask at 50 \u00b1 5 \u00b0C for 1 hour, shaking it at regular intervals of approximately 10 minutes. Filter the contents of the flask through the weighed filter crucible by means of suction. Transfer any residual fibres by washing out the flask with a little 75 % sulphuric acid. Drain the crucible with suction and wash the residue on the filter once by filling the crucible with a fresh portion of sulphuric acid. Do not apply suction until the acid has drained under gravity. Wash the residue successively several times with cold water, twice with dilute ammonia solution, and then thoroughly with cold water, draining the crucible with suction after each addition. Do not apply suction until each washing liquor has drained under gravity. Finally, drain the remaining liquid from the crucible with suction, dry the crucible and residue, and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 8 ACRYLICS, CERTAIN MODACRYLICS OR CERTAIN CHLOROFIBRES AND CERTAIN OTHER FIBRES (Method using dimethylformamide) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. acrylics (26), certain modacrylics (29), or certain chlorofibres (27) (9) with 2. wool (1), animal hair (2 and 3), silk (4), cotton (5), cupro (21), modal (22), viscose (25), polyamide or nylon (30), polyester (35), elastomultiester (45), elastolefin (46) and melamine (47). It is equally applicable to acrylics, and certain modacrylics, treated with premetallised dyes, but not to those dyed with afterchrome dyes. 2. PRINCIPLE The acrylic, modacrylic or chlorofibre is dissolved out from a known dry mass of the mixture, with dimethylformamide heated in a water-bath at boiling point. The residue is collected, washed, dried and weighed. Its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture and the percentage of dry acrylic, modacrylic or chlorofibre is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flask of at least 200 ml capacity. (b) Water bath at boiling point. 3.2. Reagent Dimethylformamide (boiling point 153 \u00b1 1 \u00b0C) not containing more than 0,1 % water. This reagent is toxic and the use of a hood is thus recommended. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: To the specimen contained in the glass-stoppered conical flask of at least 200 ml capacity, add per gram of specimen 80 ml of dimethylformamide, pre-heated in the water-bath at boiling point, insert the stopper, shake the flask to wet out the specimen and heat in the water-bath at boiling point for 1 hour. Shake the flask and its contents gently by hand five times during this period. Decant the liquid through the weighed filter crucible, retaining the fibres in the flask. Add a further 60 ml of dimethylformamide to the flask and heat for a further 30 minutes, shaking the flask and contents gently by hand twice during this period. Filter the contents of the flask through the filter crucible by means of suction. Transfer any residual fibre to the crucible by washing out the beaker with dimethylformamide. Drain the crucible with suction. Wash the residue with about 1 litre of hot water at 70-80 \u00b0C, filling the crucible each time. After each addition of water, apply suction briefly but not until the water has drained under gravity. If the washing liquor drains through the crucible too slowly slight suction may be applied. Finally dry the crucible with the residue, cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except in the case of wool, cotton, cupro, modal, polyester, elastomultiester and melamine, for which the value of \u2027d\u2027 is 1,01. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 9 CERTAIN CHLOROFIBRES AND CERTAIN OTHER FIBRES (Method using 55,5/44,5 % v/v mixture of carbon disulphide and acetone) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. certain chlorofibres (27), namely certain polyvinyl chloride fibres, whether after-chlorinated or not (10) with 2. wool (1), animal hair (2 and 3), silk (4), cotton (5), cupro (21), modal (22), viscose (25), acrylic (26), polyamide or nylon (30), polyester (35), glass fibre (44), elastomultiester (45) and melamine (47). When the wool or silk content of the mixture exceeds 25 %, method No 2 shall be used. When the polyamide or nylon content of the mixture exceeds 25 %, method No 4 shall be used. 2. PRINCIPLE The chlorofibre is dissolved out from a known dry mass of the mixture, with an azeotropic mixture of carbon disulphide and acetone. The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of dry polyvinyl chloride fibre is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flask of at least 200 ml capacity. (b) Mechanical shaker. 3.2. Reagents (a) Azeotropic mixture of carbon disulphide and acetone (55,5 % by volume carbon disulphide to 44,5 % acetone). As this reagent is toxic, the use of a hood is recommended. (b) Ethanol (92 % by volume) or methanol. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: To the specimen contained in the glass-stoppered conical flask of at least 200 ml capacity, add 100 ml of the azeotropic mixture per gram of specimen. Seal the flask securely, and shake the flask on a mechanical shaker, or vigorously by hand, for 20 minutes at room temperature. Decant the supernatant liquid through the weighed filter crucible. Repeat the treatment with 100 ml of fresh reagent. Continue this cycle of operations until no polymer deposit is left on a watch glass when a drop of the extraction liquid is evaporated. Transfer the residue to the filter crucible using more reagent, apply suction to remove the liquid, and rinse the crucible and residue with 20 ml of alcohol and then three times with water. Allow the washing liquor to drain under gravity before draining with suction. Dry the crucible and residue and cool and weigh them. Note: With certain mixtures having a high chlorofibre content there may be substantial shrinkage of the specimen during the drying procedure, as a result of which the dissolution of chlorofibre by the solvent is retarded. This does not, however, affect the ultimate dissolution of the chlorofibre in the solvent. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except for melamine, for which \u2018d\u2019 = 1,01. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of the results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 10 ACETATE AND CERTAIN OTHER FIBRES (Method using glacial acetic acid) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. acetate (19) with 2. certain chlorofibres (27) namely polyvinyl chloride fibres, whether afterchlorinated or not, elastolefin (46) and melamine (47). 2. PRINCIPLE The acetate fibre is dissolved out from a known dry mass of the mixture, with glacial acetic acid. The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of dry acetate is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flask of at least 200 ml capacity. (b) Mechanical shaker. 3.2. Reagent Glacial acetic acid (over 99 %). This reagent shall be handled with care since it is highly caustic. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: To the specimen contained in the glass-stoppered conical flask of at least 200 ml capacity, add 100 ml glacial acetic acid per gram of specimen. Seal the flask securely and shake on the mechanical shaker, or vigorously by hand, for 20 minutes at room temperature. Decant the supernatant liquid through the weighed filter crucible. Repeat this treatment twice, using 100 ml of fresh reagent each time, making three extractions in all. Transfer the residue to the filter crucible, drain with suction to remove the liquid and rinse the crucible and the residue with 50 ml of glacial acetic acid, and then three times with water. After each rinse, allow the liquid to drain under gravity before applying suction. Dry the crucible and residue, and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of the results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 11 SILK AND CERTAIN OTHER FIBRES (Method using 75 % m/m sulphuric acid) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. silk (4) with 2. wool (1), animal hair (2 and 3), elastolefin (46) and melamine (47). 2. PRINCIPLE The silk fibre is dissolved out from a known dry mass of the mixture, with 75 % m/m sulphuric acid (11). The residue is collected, washed, dried and weighed. Its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of dry silk is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus Glass-stoppered conical flask of at least 200 ml capacity. 3.2. Reagents (a) Sulphuric acid (75 \u00b1 2 % m/m) Prepare by adding carefully, while cooling, 700 ml sulphuric acid (relative density at 20 \u00b0C: 1,84) to 350 ml distilled water. After cooling to room temperature, dilute the solution to 1 litre with water. (b) Sulphuric acid, dilute solution: add 100 ml sulphuric acid (relative density at 20 \u00b0C: 1,84) slowly to 1 900 ml distilled water. (c) Ammonia, dilute solution: dilute 200 ml concentrated ammonia (relative density at 20 \u00b0C: 0,880) to 1 litre with water. 4. TEST PROCEDURE Follow the procedure described in the general instructions and proceed as follows: To the specimen contained in a glass-stoppered conical flask of at least 200 ml capacity, add 100 ml of 75 % m/m sulphuric acid per gram of specimen and insert the stopper. Shake vigorously and stand for 30 minutes at room temperature. Shake again and stand for 30 minutes. Shake a last time and filter the contents of the flask through the weighed filter crucible. Wash any remaining fibres from the flask with the 75 % sulphuric acid reagent. Wash the residue on the crucible successively with 50 ml of the dilute sulphuric acid reagent, 50 ml water and 50 ml of the dilute ammonia solution. Each time allow the fibres to remain in contact with the liquid for about 10 minutes before applying suction. Finally rinse with water, leaving the fibres in contact with the water for about 30 minutes. Drain the crucible with suction, dry the crucible and residue, and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 0,985 for wool, 1,00 for elastolefin and 1,01 for melamine. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 12 JUTE AND CERTAIN ANIMAL FIBRES (Method by determining nitrogen content) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. jute (9) with 2. certain animal fibres. The animal-fibre component may consist solely of hair (2 and 3) or wool (1) or of any mixture of the two. This method is not applicable to textile mixtures containing non-fibrous matter (dyes, finishes, etc.) with a nitrogen base. 2. PRINCIPLE The nitrogen content of the mixture is determined, and from this and the known or assumed nitrogen contents of the two components, the proportion of each component is calculated. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Kjeldahl digestion flask, 200-300 ml capacity. (b) Kjeldahl distillation apparatus with steam injection. (c) Titration apparatus, allowing precision of 0,05 ml. 3.2. Reagents (a) Toluene. (b) Methanol. (c) Sulphuric acid, relative density at 20 \u00b0C: 1,84 (12). (d) Potassium sulphate (12). (e) Selenium dioxide (12). (f) Sodium hydroxide solution (400 g/litre). Dissolve 400 g of sodium hydroxide in 400-500 ml of water and dilute to 1 litre with water. (g) Mixed indicator. Dissolve 0,1 g of methyl red in 95 ml of ethanol and 5 ml of water, and mix with 0,5 g of bromocresol green dissolved in 475 ml of ethanol and 25 ml of water. (h) Boric acid solution. Dissolve 20 g of boric acid in 1 litre of water. (i) Sulphuric acid, 0,02N (standard volumetric solution). 4. PRE-TREATMENT OF TEST SAMPLE The following pre-treatment is substituted for the pre-treatment described in the general instructions: Extract the air-dry laboratory test sample in a Soxhlet apparatus with a mixture of 1 volume of toluene and 3 volumes of methanol for 4 hours at a minimum rate of 5 cycles per hour. Allow the solvent to evaporate from the sample in air, and remove the last traces in an oven at 105 \u00b1 3 \u00b0C. Then extract the sample in water (50 ml per g of sample) by boiling under reflux for 30 minutes. Filter, return the sample to the flask, and repeat the extraction with an identical volume of water. Filter, remove excess water from the sample by squeezing, suction, or centrifuging and then allow the sample to become air-dry. Note: The toxic effects of toluene and methanol shall be borne in mind and full precautions shall be taken in their use. 5. TEST PROCEDURE 5.1. General instructions Follow the procedure described in the general instructions as regards the selection, drying and weighing of the specimen. 5.2. Detailed procedure Transfer the specimen to a Kjeldahl digestion flask. To the specimen weighing at least 1 g contained in the digestion flask, add, in the following order, 2,5 g potassium sulphate, 0,1-0,2 g selenium dioxide and 10 ml sulphuric acid (relative density at 20 \u00b0C: 1,84). Heat the flask, gently at first, until the whole of the fibre is destroyed, and then heat it more vigorously until the solution becomes clear and almost colourless. Heat it for a further 15 minutes. Allow the flask to cool, dilute the contents carefully with 10-20 ml water, cool, transfer the contents quantitatively to a 200 ml graduated flask and make up to volume with water to form the digest solution. Place about 20 ml of boric acid solution in a 100 ml conical flask and place the flask under the condenser of the Kjeldahl distillation apparatus so that the delivery tube dips just below the surface of the boric acid solution. Transfer exactly 10 ml of digest solution to the distillation flask, add not less than 5 ml of sodium hydroxide solution to the funnel, lift the stopper slightly and allow the sodium hydroxide solution to run slowly into the flask. If the digest solution and sodium hydroxide solution remain as two separate layers, mix them by gentle agitation. Heat the distillation flask gently and pass it into steam from the generator. Collect about 20 ml of distillate, lower the conical flask so that the tip of the delivery tube of the condenser is about 20 mm above the surface of the liquid and distil for 1 minute more. Rinse the tip of the delivery tube with water, catching the washings in the conical flask. Remove the conical flask and replace it with another conical flask containing roughly 10 ml of boric acid solution and collect about 10 ml distillate. Titrate the two distillates separately with 0,02 N sulphuric acid, use the mixed indicator. Record the total titre for the two distillates. If the titre for the second distillate is more than 0,2 ml, repeat the test and start the distillation again using a fresh aliquot of digest solution. Carry out a blank determination, i.e. digestion and distillation using the reagents only. 6. CALCULATION AND EXPRESSION OF RESULTS 6.1. Calculate the percentage nitrogen content in the dry specimen as follows: where A = percentage nitrogen in the clean dry specimen, V = total volume in ml of standard sulphuric acid used in the determination, b = total volume in ml of standard sulphuric acid used in the blank determination, N = normality of standard sulphuric acid, W = dry mass (g) of specimen. 6.2. Using the values of 0,22 % for the nitrogen content of jute and 16,2 % for the nitrogen content of animal fibre, both percentages being expressed on the dry mass of the fibre, calculate the composition of the mixture as follows: where PA% = percentage of animal fibre in the clean dry specimen. 7. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 13 POLYPROPYLENE FIBRES AND CERTAIN OTHER FIBRES (Xylene method) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. polypropylene fibres (37) with 2. wool (1), animal hair (2 and 3), silk (4), cotton (5), acetate (19), cupro (21), modal (22), triacetate (24), viscose (25), acrylic (26), polyamide or nylon (30), polyester (35), glass fibre (44), elastomultiester (45) and melamine (47). 2. PRINCIPLE The polypropylene fibre is dissolved out from a known dry mass of the mixture with boiling xylene. The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of polypropylene is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flask of at least 200 ml capacity. (b) Reflux condenser (suitable for liquids of high boiling point), fitting the conical flask (a). (c) Heating mantle at boiling point of xylene. 3.2. Reagent Xylene distilling between 137 and 142 \u00b0C. Note: Xylene is highly flammable and has a toxic vapour. Suitable precautions must be taken in its use. 4. TEST PROCEDURE Follow the procedure described in the general instructions then proceed as follows: To the specimen contained in the conical flask (3.1(a)), add 100 ml of xylene (3.2) per gram of specimen. Attach the condenser (3.1(b)), bring the contents to the boil and maintain at boiling point for 3 minutes. Immediately decant the hot liquid through the weighed filter crucible (see Note 1). Repeat this treatment twice more, each time using a fresh 50 ml portion of solvent. Wash the residue remaining in the flask successively with 30 ml of boiling xylene (twice), then with 75 ml of light petroleum (I.3.2.1 of general instructions) (twice). After the second wash with light petroleum, filter the contents of the flask through the crucible, transfer any residual fibres to the crucible with the aid of a small quantity of light petroleum and allow the solvent to evaporate. Dry the crucible and residue, cool and weigh them. Notes: 1. The filter crucible through which the xylene is to be decanted must be pre-heated. 2. After the treatment with boiling xylene, ensure that the flask containing the residue is cooled sufficiently before the light petroleum is introduced. 3. In order to reduce the fire and toxicity hazards to the operator, a hot extraction apparatus using the appropriate procedures, giving identical results, may be used (13). 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except for melamine, for which \u2018d\u2019 = 1,01. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 14 CERTAIN FIBRES AND CHLOROFIBRES (HOMOPOLYMERS OF VINYL CHLORIDE), ELASTOLEFIN OR MELAMINE (Concentrated sulphuric acid method) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. cotton (5), acetate (19), cupro (21), modal (22), triacetate (24), viscose (25), certain acrylics (26), certain modacrylics (29), polyamide or nylon (30), polyester (35) and elastomultiester (45) with 2. chlorofibres (27) based on homopolymers of vinyl chloride, whether after-chlorinated or not, elastolefin (46) and melamine (47). The modacrylics concerned are those which give a limpid solution when immersed in concentrated sulphuric acid (relative density at 20 \u00b0C: 1,84). This method can be used in place of methods No 8 and No 9. 2. PRINCIPLE The constituent other than the chlorofibre, the elastolefin or the melamine (i.e. the fibres mentioned in point 1.1) is dissolved out from a known dry mass of the mixture with concentrated sulphuric acid (relative density at 20 \u00b0C: 1,84). The residue, consisting of the chlorofibre, the elastolefin or the melamine, is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of the second constituents is obtained by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flask of at least 200 ml capacity. (b) Glass rod with flattened end. 3.2. Reagents (a) Sulphuric acid, concentrated (relative density at 20 \u00b0C: 1,84). (b) Sulphuric acid, approximately 50 % (m/m) aqueous solution. Prepare by adding carefully, while cooling, 400 ml of sulphuric acid (relative density at 20 \u00b0C: 1,84) to 500 ml of distilled or deionised water. After cooling to room temperature, dilute the solution to one litre with water. (c) Ammonia, dilute solution. Dilute 60 ml of concentrated ammonia solution (relative density at 20 \u00b0C: 0,880) to one litre with distilled water. 4. TEST PROCEDURE Follow the procedure described in the general instructions, then proceed as follows: To the test specimen contained in the flask (3.1(a)) add 100 ml of sulphuric acid (3.2(a)) per gram of specimen. Allow the contents of the flask to remain at room temperature for 10 minutes and during that time stir the test specimen occasionally by means of the glass rod. If a woven or knitted fabric is being treated, wedge it between the wall of the flask and the glass rod and exert a light pressure in order to separate the material dissolved by the sulphuric acid. Decant the liquid through the weighed filter crucible. Add to the flask a fresh portion of 100 ml of sulphuric acid (3.2(a)) and repeat the same operation. Transfer the contents of the flask to the filter crucible and transfer the fibrous residue there with the aid of the glass rod. If necessary, add a little concentrated sulphuric acid (3.2(a)) to the flask in order to remove any fibres adhering to the wall. Drain the filter crucible with suction; remove the filtrate by emptying or changing the filter-flask, wash the residue in the crucible successively with 50 % sulphuric acid solution (3.2(b)), distilled or deionised water (I.3.2.3 of the general instructions), ammonia solution (3.2(c)) and finally wash thoroughly with distilled or deionised water, draining the crucible with suction after each addition. (Do not apply suction during the washing operation, but only after the liquid has drained off by gravity.) Dry the crucible and residue, cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00, except for melamine, for which \u2018d\u2019 = 1,01. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. METHOD No 15 CHLOROFIBRES, CERTAIN MODACRYLICS, CERTAIN ELASTANES, ACETATES, TRIACETATES AND CERTAIN OTHER FIBRES (Method using cyclohexanone) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. acetate (19), triacetate (24), chlorofibre (27), certain modacrylics (29), certain elastanes (43) with 2. wool (1), animal hair (2 and 3), silk (4), cotton (5), cupro (21), modal (22), viscose (25), polyamide or nylon (30), acrylic (26), glass fibre (44) and melamine (47). Where modacrylics or elastanes are present a preliminary test must first be carried out to determine whether the fibre is completely soluble in the reagent. It is also possible to analyse mixtures containing chlorofibres by using method No 9 or 14. 2. PRINCIPLE The acetate and triacetate fibres, chlorofibres, certain modacrylics, and certain elastanes are dissolved out from a known dry mass with cyclohexanone at a temperature close to boiling point. The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of chlorofibre, modacrylic, elastane, acetate and triacetate is found by difference. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Hot extraction apparatus suitable for use in the test procedure in point 4 (see figure: this is a variant of the apparatus described in Melliand Textilberichte 56 (1975) pp. 643-645). (b) Filter crucible to contain the test specimen. (c) Porous baffle (porosity grade 1). (d) Reflux condenser that can be adapted to the distillation flask. (e) Heating device. 3.2. Reagents (a) Cyclohexanone, boiling point 156 \u00b0C. (b) Ethyl alcohol, 50 % by volume. Note: Cyclohexanone is flammable and toxic. Suitable precautions must be taken in its use. 4. TEST PROCEDURE Follow the procedure described in the general instructions and then proceed as follows: Pour into the distillation flask 100 ml of cyclohexanone per gram of material, insert the extraction container in which the filter crucible, containing the specimen and the porous baffle, slightly inclined, have previously been placed. Insert the reflux condenser. Bring to the boil and continue extraction for 60 minutes at a minimum rate of 12 cycles per hour. After extraction and cooling remove the extraction container, take out the filter crucible and remove the porous baffle. Wash the contents of the filter crucible three or four times with 50 % ethyl alcohol heated to about 60 \u00b0C and subsequently with 1 litre of water at 60 \u00b0C. Do not apply suction during or between the washing operations. Allow the liquid to drain under gravity and then apply suction. Finally, dry the crucible with the residue, cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,00 except in the case of silk and melamine for which \u2018d\u2019 = 1,01, and acrylic, for which \u2018d\u2019 = 0,98. 6. PRECISION On homogeneous mixtures of textile fibres, the confidence limits of results obtained by this method are not greater than \u00b1 1 for a confidence level of 95 %. Figure referred to in point 3.1(a) of method No 15 METHOD No 16 MELAMINE AND CERTAIN OTHER FIBRES (Method using hot formic acid) 1. FIELD OF APPLICATION This method is applicable, after removal of non-fibrous matter, to binary fibre mixtures of: 1. melamine (47) with 2. cotton (5) and aramid (31). 2. PRINCIPLE The melamine is dissolved out from a known dry mass of the mixture with hot formic acid (90 % m/m). The residue is collected, washed, dried and weighed; its mass, corrected if necessary, is expressed as a percentage of the dry mass of the mixture. The percentage of the second constituents is obtained by difference. Note: Keep strictly the recommended temperature range because the solubility of melamine is very much dependent on temperature. 3. APPARATUS AND REAGENTS (other than those specified in the general instructions) 3.1. Apparatus (a) Glass-stoppered conical flask of at least 200 ml capacity. (b) Shaking water bath or other apparatus to shake and maintain the flask at 90 \u00b1 2 \u00b0C. 3.2. Reagents (a) Formic acid (90 % m/m, relative density at 20 \u00b0C: 1,204). Dilute 890 ml of 98 to 100 % m/m formic acid (relative density at 20 \u00b0C: 1,220) to 1 litre with water. Hot formic acid is very corrosive and must be handled with care. (b) Ammonia, dilute solution: dilute 80 ml of concentrated ammonia solution (relative density at 20 \u00b0C: 0,880) to 1 litre with water. 4. TEST PROCEDURE Follow the procedure described in the general instructions, then proceed as follows: To the test specimen contained in the glass-stoppered conical flask of at least 200 ml capacity, add 100 ml of formic acid per gram of specimen. Insert the stopper and shake the flask to wet out the specimen. Maintain the flask in a shaking water bath at 90 \u00b1 2 \u00b0C for 1 hour, shaking it vigorously. Cool the flask to room temperature. Decant the liquid through the weighed filter crucible. Add 50 ml of formic acid to the flask containing the residue, shake manually and filter the contents of the flask through the filter crucible. Transfer any residual fibres to the crucible by washing out the flask with a little more formic acid reagent. Drain the crucible with suction and wash the residue with formic acid reagent, hot water, dilute ammonia solution, and finally cold water, draining the crucible with suction after each addition. Do not apply suction until each washing liquor has drained under gravity. Finally, drain the crucible with suction, dry the crucible and residue, and cool and weigh them. 5. CALCULATION AND EXPRESSION OF RESULTS Calculate the results as described in the general instructions. The value of \u2018d\u2019 is 1,02. 6. PRECISION On a homogeneous mixture of textile materials, the confidence limits of results obtained by this method are not greater than \u00b1 2 for a confidence level of 95 %. CHAPTER 3 QUANTITATIVE ANALYSIS OF TERNARY TEXTILE FIBRE MIXTURES INTRODUCTION In general, the methods of quantitative chemical analysis are based on the selective solution of the individual components. There are four possible variants of this method: 1. Using two different test specimens, a component (a) is dissolved from the first test specimen, and another component (b) from the second test specimen. The insoluble residues of each specimen are weighed and the percentage of each of the two soluble components is calculated from the respective losses in mass. The percentage of the third component (c) is calculated by difference. 2. Using two different test specimens, a component (a) is dissolved from the first test specimen and two components (a and b) from the second test specimen. The insoluble residue of the first test specimen is weighed and the percentage of the component (a) is calculated from the loss in mass. The insoluble residue of the second test specimen is weighed; it corresponds to component (c). The percentage of the third component (b) is calculated by difference. 3. Using two different test specimens, two components (a and b) are dissolved from the first test specimen and two components (b and c) from the second test specimen. The insoluble residues correspond to the two components (c) and (a) respectively. The percentage of the third component (b) is calculated by difference. 4. Using only one test specimen, after removal of one of the components, the insoluble residue formed by the two other fibres is weighed and the percentage of the soluble component is calculated from the loss in mass. One of the two fibres of the residue is dissolved, the insoluble component is weighed and the percentage of the second soluble component is calculated from the loss in mass. Where a choice is possible, it is advisable to use one of the first three variants. Where chemical analysis is used, the expert responsible for the analysis must take care to select methods employing solvents which dissolve only the correct fibre(s), leaving the other fibre(s) intact. By way of example, a table is given in Section V which contains a certain number of ternary fibre mixtures, together with methods for analysing binary fibre mixtures which can, in principle, be used for analysing these ternary fibre mixtures. In order to reduce the possibility of error to a minimum, it is recommended that, whenever possible, chemical analysis using at least two of the four abovementioned variants shall be made. Before proceeding with any analysis, all the fibres present in the mixture must be identified. In some chemical methods, the insoluble component of a mixture may be partially dissolved in the reagent used to dissolve the soluble component(s). Wherever possible, reagents have been chosen that have little or no effect on the insoluble fibres. If a loss in mass is known to occur during the analysis, the result shall be corrected; correction factors are given for this purpose. These factors have been determined in several laboratories by treating, with the appropriate reagent as specified in the method of analysis, fibres cleaned by the pre-treatment. These correction factors apply only to undergraded fibres and different correction factors may be necessary if the fibres have been degraded before or during processing. If the fourth variant, in which a textile fibre is subjected to the successive action of two different solvents, must be used, correction factors must be applied for possible losses in mass undergone by the fibre in the two treatments. At least two determinations shall be made, both in the case of manual separation and in the case of chemical separation. I. General information on methods for the quantitative chemical analysis of ternary fibre mixtures Information common to the methods given for the quantitative chemical analysis of ternary fibre mixtures. I.1. FIELD OF APPLICATION The field of application of each method for analysing binary fibre mixtures specifies to which fibres the method is applicable (see Chapter 2 relating to methods for quantitative analysis of certain binary textile fibre mixtures). I.2. PRINCIPLE After the identification of the components of a mixture, the non-fibrous material is removed by suitable pre-treatment and then one or more of the four variants of the process of selective solution described in the introduction is applied. Except where this presents technical difficulties, it is preferable to dissolve the major fibre component so as to obtain the minor fibre component as final residue. I.3. MATERIALS AND EQUIPMENT I.3.1. Apparatus I.3.1.1. Filter crucibles and weighing bottles large enough to contain such crucibles, or any other apparatus giving identical results. I.3.1.2. Vacuum flask. I.3.1.3. Desiccator containing self-indicating silica gel. I.3.1.4. Ventilated oven for drying specimens at 105 \u00b1 3 \u00b0C. I.3.1.5. Analytical balance, accurate to 0,0002 g. I.3.1.6. Soxhlet extractor or other apparatus giving identical results. I.3.2. Reagents I.3.2.1. Light petroleum, redistilled, boiling range 40 to 60 \u00b0C. I.3.2.2. Other reagents are specified in the appropriate sections of each method. I.3.2.3. Distilled or deionised water. I.3.2.4. Acetone. I.3.2.5. Orthophosphoric acid. I.3.2.6. Urea. I.3.2.7. Sodium bicarbonate. All reagents used shall be chemically pure. I.4. CONDITIONING AND TESTING ATMOSPHERE Because dry masses are determined, it is unnecessary to condition the specimen or to conduct analyses in a conditioned atmosphere. I.5. LABORATORY TEST SAMPLE Take a laboratory test sample that is representative of the laboratory bulk sample and sufficient to provide all the specimens, each of at least 1 g, that are required. I.6. PRE-TREATMENT OF LABORATORY TEST SAMPLE (14) Where a substance not to be taken into account in the percentage calculations (see Article 19) is present, it shall first be removed by a suitable method that does not affect any of the fibre constituents. For this purpose, non-fibrous matter which can be extracted with light petroleum and water is removed by treating the laboratory test sample in a Soxhlet extractor with light petroleum for 1 hour at a minimum rate of six cycles per hour. Allow the light petroleum to evaporate from the laboratory test sample, which is then extracted by direct treatment consisting in soaking the laboratory test sample in water at room temperature for 1 hour and then soaking it in water at 65 \u00b1 5 \u00b0C for a further hour, agitating the liquor from time to time. Use a liquor: laboratory test sample ratio of 100:1. Remove the excess water from the laboratory test sample by squeezing, suction or centrifuging and then allow the laboratory test sample to become air-dry. In the case of elastolefin or fibre mixtures containing elastolefin and other fibres (wool, animal hair, silk, cotton, flax (or linen), true hemp, jute, abaca, alfa, coir, broom, ramie, sisal, cupro, modal, protein, viscose, acrylic, polyamide or nylon, polyester, elastomultiester) the procedure just described shall be slightly modified, in fact light petroleum ether shall be replaced by acetone. Where non-fibrous matter cannot be extracted with light petroleum and water, it shall be removed by substituting for the water method described above a suitable method that does not substantially alter any of the fibre constituents. However, for some unbleached, natural vegetable fibres (e.g. jute, coir) it is to be noted that normal pre-treatment with light petroleum and water does not remove all the natural non-fibrous substances; nevertheless additional pre-treatment is not applied unless the sample contains finishes insoluble in both light petroleum and water. Analysis reports shall include full details of the methods of pre-treatment used. I.7. TEST PROCEDURE I.7.1. General instructions I.7.1.1. Drying Conduct all drying operations for not less than 4 hours and not more than 16 hours at 105 \u00b1 3 \u00b0C in a ventilated oven with the oven door closed throughout. If the drying period is less than 14 hours, the specimen must be checkweighed to determine whether its mass is constant. The mass may be considered as constant if, after a further drying period of 60 minutes, its variation is less than 0,05 %. Avoid handling crucibles and weighing bottles, specimens or residues with bare hands during the drying, cooling and weighing operations. Dry specimens in a weighing bottle with its cover beside it. After drying, stopper the weighing bottle before removing it from the oven, and transfer it quickly to the desiccator. Dry the filter crucible in a weighing bottle with its cover beside it in the oven. After drying, close the weighing bottle and transfer it quickly to the desiccator. Where apparatus other than a filter crucible is used, drying operations shall be conducted in the oven so as to determine the dry mass of the fibres without loss. I.7.1.2. Cooling Conduct all cooling operations in the desiccator, placed beside the balance, until the cooling of the weighing bottles is complete, and in any case for not less than 2 hours. I.7.1.3. Weighing After cooling, complete the weighing of the weighing bottle within 2 minutes of its removal from the desiccator; weigh to an accuracy of 0,0002 g. I.7.2. Procedure Take from the pre-treated laboratory test sample a test specimen of at least 1 g (in mass). Cut yarn or cloth into lengths of about 10 mm, dissected as much as possible. Dry the specimen in a weighing bottle, cool it in the desiccator and weigh it. Transfer the specimen to the glass vessel specified in the appropriate section of the Union method, reweigh the weighing bottle immediately and obtain the dry mass of the specimen by difference; complete the test as specified in the appropriate section of the applicable method. Examine the residue microscopically to check that the treatment has in fact completely removed the soluble fibre(s). I.8. CALCULATION AND EXPRESSION OF RESULTS Express the mass of each component as a percentage of the total mass of fibre in the mixture. Calculate the results on the basis of dean dry mass, adjusted by (a) the agreed allowances and (b) the correction factors necessary to take account of loss of non-fibrous matter during pre-treatment and analysis. I.8.1. Calculation of percentages of mass of clean dry fibres disregarding loss of fibre mass during pre-treatment. I.8.1.1. - VARIANT 1 - Formulae to be applied where a component of the mixture is removed from one specimen and another component from a second specimen: P 3% = 100 \u2013 (P 1% + P 2%) P1% is the percentage of the first clean dry component (component in the first specimen dissolved in the first reagent), P2% is the percentage of the second clean dry component (component in the second specimen dissolved in the second reagent), P3% is the percentage of the third clean dry component (component undissolved in both specimens), m1 is the dry mass of the first specimen after pre-treatment, m2 is the dry mass of the second specimen after pre-treatment, r1 is the dry mass of the residue after removal of the first component from the first specimen in the first reagent, r2 is the dry mass of the residue after removal of the second component from the second specimen in the second reagent, d1 is the correction factor for loss in mass in the first reagent, of the second component undissolved in the first specimen (15); d2 is the correction factor for loss in mass in the first reagent, of the third component undissolved in the first specimen, d3 is the correction factor for loss in mass in the second reagent, of the first component undissolved in the second specimen, d4 is the correction factor for loss in mass in the second reagent, of the third component undissolved in the second specimen. I.8.1.2. - VARIANT 2 - Formulae to be applied where a component (a) is removed from the first test specimen, leaving as residue the other two components (b + c), and two components (a + b) are removed from the second test specimen, leaving as residue the third component (c): P 1% = 100 \u2013 (P 2% + P 3%) P1% is the percentage of the first clean dry component (component in the first specimen dissolved in the first reagent), P2% is the percentage of the second clean dry component (component soluble, at the same time as the first component of the second specimen, in the second reagent), P3% is the percentage of the third clean dry component (component undissolved in both specimens), m1 is the dry mass of the first specimen after pre-treatment, m2 is the dry mass of the second specimen after pre-treatment, r1 is the dry mass of the residue after removal of the first component from the first specimen in the first reagent, r2 is the dry mass of the residue after removal of the first and second components from the second specimen in the second reagent, d1 is the correction factor for loss in mass in the first reagent, of the second component undissolved in the first specimen, d2 is the correction factor for loss in mass in the first reagent, of the third component undissolved in the first specimen, d4 is the correction factor for loss in mass in the second reagent, of the third component undissolved in the second specimen. I.8.1.3. - VARIANT 3 - Formulae to be applied where two components (a + b) are removed from a specimen, leaving as residue the third component (c), then two components (b + c) are removed from another specimen, leaving as residue the first component (a): P 2% = 100 \u2013 (P 1% + P 3%) P1% is the percentage of the first clean dry component (component dissolved by the reagent), P2% is the percentage of the second clean dry component (component dissolved by the reagent), P3% is the percentage of the third clean dry component (component dissolved in the second specimen by the reagent), m1 is the dry mass of the first specimen after pre-treatment, m2 is the dry mass of the second specimen after pre-treatment, r1 is the dry mass of the residue after the removal of the first and second components from the first specimen with the first reagent, r2 is the dry mass of the residue after the removal of the second and third components from the second specimen with the second reagent, d2 is the correction factor for loss in mass in the first reagent of the third component undissolved in the first specimen, d3 is the correction factor for loss in mass in the second reagent of the first component undissolved in the second specimen. I.8.1.4. - VARIANT 4 - Formulae to be applied where two components are successively removed from the mixture using the same specimen: P 1% = 100 \u2013 (P 2% + P 3%) P1% is the percentage of the first clean dry component (first soluble component), P2% is the percentage of the second clean dry component (second soluble component), P3% is the percentage of the third clean dry component (insoluble component), m is the dry mass of the specimen after pre-treatment, r1 is the dry mass of the residue after elimination of the first component by the first reagent, r2 is the dry mass of the residue after elimination of the first and second component by the first and second reagents, d1 is the correction factor for loss in mass of the second component in the first reagent, d2 is the correction factor for loss in mass of the third component in the first reagent, d3 is the correction factor for loss in mass of the third component in the first and second reagents (16). I.8.2. Calculation of the percentage of each component with adjustment by agreed allowances and, where appropriate, correction factors for losses in mass during pre-treatment operations: Given: then: P1A% is the percentage of the first clean dry component, including moisture content and loss in mass during pre-treatment, P2A% is the percentage of the second clean dry component, including moisture content and loss in mass during pre-treatment, P3A% is the percentage of the third clean dry component, including moisture content and loss in mass during pre-treatment, P1 is the percentage of the first clean dry component obtained by one of the formulae given in I.8.1, P2 is the percentage of the second clean dry component obtained by one of the formulae given in I.8.1, P3 is the percentage of the third clean dry component obtained by one of the formulae given in I.8.1, a1 is the agreed allowance of the first component, a2 is the agreed allowance of the second component, a3 is the agreed allowance of the third component, b1 is the percentage of loss in mass of the first component during pre-treatment, b2 is the percentage of loss in mass of the second component during pre-treatment, b3 is the percentage of loss in mass of the third component during pre-treatment. Where a special pre-treatment is used the values b1, b2 and b3 shall be determined, if possible, by submitting each of the pure fibre constituents to the pre-treatment applied in the analysis. Pure fibres are those free from all non-fibrous material except those which they normally contain (either naturally or because of the manufacturing process), in the state (unbleached, bleached) in which they are found in the material to be analysed. Where no clean separate constituent fibres used in the manufacture of the material to be analysed are available, average values of b1, b2 and b3 as obtained from tests performed on clean fibres similar to those in the mixture under examination, must be used. If normal pre-treatment by extraction with light petroleum and water is applied, correction factors b1, b2 and b3 may generally be ignored, except in the case of unbleached cotton, unbleached flax (or linen) and unbleached hemp where the loss due to pre-treatment is usually accepted as 4 % and in the case of polypropylene as 1 %. In the case of other fibres, losses due to pre-treatment are usually disregarded in calculations. I.8.3. Note: Calculation examples are given in Section IV. II. Method of quantitative analysis by manual separation of ternary fibre mixtures II.1. FIELD OF APPLICATION This method is applicable to textile fibres of all types provided they do not form an intimate mixture and that it is possible to separate them by hand. II.2. PRINCIPLE After identification of the textile components, the non-fibrous matter is removed by a suitable pre-treatment and then the fibres are separated by hand, dried and weighed in order to calculate the proportion of each fibre in the mixture. II.3. APPARATUS II.3.1. Weighing bottles or other apparatus giving identical results. II.3.2. Desiccator containing self-indicating silica gel. II.3.3. Ventilated oven for drying specimens at 105 \u00b1 3 \u00b0C. II.3.4. Analytical balance accurate to 0,0002 g. II.3.5. Soxhlet extractor, or other apparatus giving identical results. II.3.6. Needle. II.3.7. Twist tester or similar apparatus. II.4. REAGENTS II.4.1. Light petroleum, redistilled, boiling range 40 to 60 \u00b0C. II.4.2. Distilled or deionised water. II.5. CONDITIONING AND TESTING ATMOSPHERE See I.4. II.6. LABORATORY TEST SAMPLE See I.5. II.7. PRE-TREATMENT OF LABORATORY TEST SAMPLES See I.6. II.8. PROCEDURE II.8.1. Analysis of yarn Take from the pre-treated laboratory test sample a specimen of mass not less than 1 g. For a very fine yarn, the analysis may be made on a minimum length of 30 m, whatever its mass. Cut the yarn into pieces of a suitable length and separate the fibre types by means of a needle and, if necessary, a twist tester. The fibre types so obtained are placed in pre-weighed weighing bottles and dried at 105 \u00b1 3 \u00b0C to constant mass, as described in I.7.1 and I.7.2. II.8.2. Analysis of cloth Take from the pre-treated laboratory test sample a specimen of mass not less than 1 g, not including a selvedge with edges carefully trimmed to avoid fraying and running parallel with weft or warp yarns, or in the case of knitted fabrics in the line of the wales and courses. Separate the different types of fibres and collect them in pre-weighed weighing bottles and proceed as described in II.8.1. II.9. CALCULATION AND EXPRESSION OF RESULTS Express the mass of each component fibre as a percentage of the total mass of the fibres in the mixture. Calculate the results on the basis of clean dry mass, adjusted by (a) the agreed allowances and (b) the correction factors necessary to take account of losses in mass during pre-treatment operations. II.9.1. Calculation of percentage masses of clean dry fibre, disregarding loss in fibre mass during pre-treatment: P 3% = 100 \u2013 (P 1% + P 2%) P1% is the percentage of the first clean dry component, P2% is the percentage of the second clean dry component, P3% is the percentage of the third clean dry component, m1 is the clean dry mass of the first component, m2 is the clean dry mass of the second component, m3 is the clean dry mass of the third component. II.9.2. For calculation of the percentage of each component with adjustment by agreed allowances and, where appropriate, by correction factors for losses in mass during pre-treatment: see I.8.2. III. Method of quantitative analysis of ternary fibre mixtures by a combination of manual separation and chemical separation Wherever possible, manual separation shall be used, taking account of the proportions of components separated before proceeding to any chemical treatment of each of the separate components. III.1. PRECISION OF THE METHODS The precision indicated in each method of analysis of binary fibre mixtures relates to the reproducibility (see Chapter 2 relating to methods for quantitative analysis of certain binary textile fibre mixtures). Reproducibility refers to the reliability, i.e. the closeness of agreement between experimental values obtained by operators in different laboratories or at different times using the same method and obtaining individual results on specimens of an identical homogeneous mixture. Reproducibility is expressed by confidence limits of the results for a confidence level of 95 %. By this is meant that the difference between two results in a series of analyses made in different laboratories would, given a normal and correct application of the method to an identical and homogeneous mixture, exceed the confidence limit only in five cases out of 100. To determine the precision of the analysis of a ternary fibre mixture the values indicated in the methods for the analysis of binary fibre mixtures which have been used to analyse the ternary fibre mixture are applied in the usual way. Given that in the four variants of the quantitative chemical analysis of ternary fibre mixtures, provision is made for two dissolutions (using two separate specimens for the first three variants and a single specimen for the fourth variant) and, assuming that E1 and E2 denote the precision of the two methods for analysing binary fibre mixtures, the precision of the results for each component is shown in the following table: Component fibre Variants 1 2 and 3 4 a E1 E1 E1 b E2 E1 + E2 E1 + E2 c E1 + E2 E2 E1 + E2 If the fourth variant is used, the degree of precision may be found to be lower than that calculated by the method indicated above, owing to possible action of the first reagent on the residue consisting of components b and c, which would be difficult to evaluate. III.2. TEST REPORT III.2.1. Indicate the variant(s) used to carry out the analysis, the methods, reagents and correction factors. III.2.2. Give details of any special pre-treatments (see I.6). III.2.3. Give the individual results and the arithmetic mean, each to the first decimal place. III.2.4. Wherever possible, state the precision of the method for each component, calculated according to the table in Section III.1. IV. Examples of the calculation of percentages of the components of certain ternary fibre mixtures using some of the variants described in point I.8.1. Consider the case of a fibre mixture which gave the following components when qualitatively analysed for raw material composition: 1. carded wool; 2. nylon (polyamide); 3. unbleached cotton. VARIANT No 1 Using this variant, that is using two different specimens and removing one component (a = wool) by dissolution from the first specimen and a second component (b = polyamide) from the second specimen, the following results can be obtained: 1. Dry mass of the first specimen after pre-treatment is (m1) = 1,6000 g 2. Dry mass of the residue after treatment with alkaline sodium hypochlorite (polyamide + cotton) (r1) = 1,4166 g 3. Dry mass of the second specimen after pre-treatment (m2) = 1,8000 g 4. Dry mass of the residue after treatment with formic acid (wool + cotton) (r2) = 0,9000 g Treatment with alkaline sodium hypochlorite does not entail any loss in mass of polyamide, while unbleached cotton loses 3 %, therefore d1 = 1,00 and d2 = 1,03. Treatment with formic acid does not entail any loss in mass for wool or unbleached cotton, therefore d3 and d4 = 1,00. If the values obtained by chemical analysis and the correction factors are substituted in the formula under I.8.1.1, the following result is obtained: P1% (wool) = [1,03/1,00 \u2013 1,03 \u00d7 1,4166/1,6000 + (0,9000/1,8000) \u00d7 (1 \u2013 1,03/1,00)] \u00d7100 = 10,30 P2% (polyamide) = [1,00/1,00 \u2013 1,00 \u00d7 0,9000/1,8000 + (1,4166/1,6000) \u00d7 (1 \u2013 1,00/1,00)] \u00d7 100 = 50,00 P3% (cotton) = 100 \u2013 (10,30 + 50,00) = 39,70 The percentages of the various clean dry fibres in the mixture are as follows: wool 10,30 % polyamide 50,00 % cotton 39,70 % These percentages must be corrected according to the formulae under I.8.2, in order to take account of the agreed allowances and the correction factors for any losses in mass after pre-treatment. As indicated in Annex IX, the agreed allowances are as follows: carded wool 17,00 %, polyamide 6,25 %, cotton 8,50 %, also unbleached cotton shows a loss in mass of 4 %, after pre-treatment with light petroleum and water. Therefore: P1A% (wool) = 10,30 \u00d7 [1 + (17,00 + 0,0)/100] / [10,30 \u00d7 (1 + (17,00 + 0,0)/100) + 50,00 \u00d7 (1 + (6,25 + 0,0)/100) + 39,70 \u00d7 (1 + (8,50 + 4,0)/100)] \u00d7 100 = 10,97 P2A% (polyamide) = 50,0 \u00d7 [(1 + (6,25 + 0,0)/100)/109,8385] \u00d7 100 = 48,37 P3A% (cotton) = 100 \u2013 (10,97 + 48,37) = 40,66 The raw material composition of the yarn is therefore as follows: polyamide 48,4 % cotton 40,6 % wool 11,0 % 100,0 % VARIANT No 4 Consider the case of a fibre mixture which when qualitatively analysed gave the following components: carded wool, viscose, unbleached cotton. Suppose that using variant 4, that is successively removing two components from the mixture of one single specimen, the following results are obtained: 1. Dry mass of the specimen after pre-treatment (m) = 1,6000 g 2. Dry mass of the residue after treatment with alkaline sodium hypochlorite (viscose + cotton) (r1) = 1,4166 g 3. Dry mass of the residue after the second treatment of the residue r1 with zinc chloride/formic acid (cotton) (r2) = 0,6630 g Treatment with alkaline sodium hypochlorite does not entail any loss in mass of viscose, while unbleached cotton loses 3 %, therefore d1 =1,00 and d2 = 1,03. As a result of treatment with formic acid-zinc chloride, the mass of cotton increases by 4 %, so that d3 = 1,03 \u00d7 0,96 = 0,9888, rounded to 0,99, (d3 being the correction factor for the respective loss or increase in mass of the third component in the first and second reagents). If the values obtained by chemical analysis and the correction factors are substituted in the formulae given in I.8.1.4, the following result is obtained: P2% (viscose) = 1,00 \u00d7 (1,4166/1,6000) \u00d7 100 \u2013 (1,00/1,03) \u00d7 41,02 = 48,71 % P3% (cotton) = 0,99 \u00d7 (0,6630/1,6000) \u00d7 100 = 41,02 % P1% (wool) = 100 \u2013 (48,71 + 41,02) = 10,27 % As has already been indicated for Variant 1, these percentages must be corrected by the formulae indicated in point I.8.2. P1A% (wool) = 10,27 \u00d7 [1 + (17,0 + 0,0)/100)]/[10,27 \u00d7 (1 + (17,00 + 0,0)/100) +48,71 \u00d7 (1 + (13 + 0,0)/100) + 41,02 \u00d7 (1 + (8,5 + 4,0)/100)] \u00d7 100 = 10,61 % P2A% (viscose) = 48,71 \u00d7 [1 + (13 + 0,0)/100] / 113,2057 \u00d7 100 = 48,62 % P3A% (cotton) = 100 \u2013 (10,61 + 48,62) = 40,77 % The raw material composition of the mixture is therefore as follows: viscose 48,6 % cotton 40,8 % wool 10,6 % \u2014 100,0 % V. Table of typical ternary fibre mixtures which may be analysed using Union methods of analysis of binary fibre mixtures (for illustration purposes) Mixture No Component fibres Variant Number of method used and reagent for binary fibre mixtures Component 1 Component 2 Component 3 1. wool or hair viscose, cupro or certain types of modal cotton 1 and/or 4 2. (hypochlorite) and 3. (zinc chloride/formic acid) 2. wool or hair polyamide or nylon cotton, viscose, cupro or modal 1 and/or 4 2. (hypochlorite) and 4. (formic acid, 80 % m/m) 3. wool, hair or silk certain other fibres viscose, cupro modal or cotton 1 and/or 4 2. (hypochlorite) and 9. (carbon disulphide/acetone 55,5/44,5 % v/v) 4. wool or hair polyamide or nylon polyester, polypropylene, acrylic or glass fibre 1 and/or 4 2. (hypochlorite) and 4. (formic acid, 80 % m/m) 5. wool, hair or silk certain other fibres polyester, acrylic, polyamide or nylon or glass fibre 1 and/or 4 2. (hypochlorite) and 9. (carbon disulphide/acetone 55,5/44,5 % v/v) 6. silk wool or hair polyester 2 11. (sulphuric acid 75 % m/m) and 2. (hypochlorite) 7. polyamide or nylon acrylic or certain other fibres cotton, viscose, cupro or modal 1 and/or 4 4. (formic acid 80 % m/m) and 8. (dimethylformamide) 8. certain chlorofibres polyamide or nylon cotton, viscose, cupro or modal 1 and/or 4 8. (dimethylformamide) and 4. (formic acid, 80 % m/m) or 9. (carbon disulphide/acetone, 55,5/44,5 % v/v) and 4. (formic acid, 80 % m/m) 9. acrylic polyamide or nylon polyester 1 and/or 4 8. (dimethylformamide) and 4. (formic acid, 80 % m/m) 10. acetate polyamide or nylon or certain other fibres viscose, cotton, cupro or modal 4 1. (acetone) and 4. (formic acid, 80 % m/m) 11. certain chlorofibres acrylic or certain other fibres polyamide or nylon 2 and/or 4 9. (carbon disulphide/acetone 55,5/44,5 % v/v) and 8. (dimethylformamide) 12. certain chlorofibres polyamide or nylon acrylic 1 and/or 4 9. (carbon disulphide/acetone 55,5/44,5 % v/v) and 4. (formic acid, 80 %m/m) 13. polyamide or nylon viscose, cupro, modal or cotton polyester 4 4. (formic acid, 80 % m/m) and 7. (sulphuric acid, 75 % m/m) 14. acetate viscose, cupro, modal or cotton polyester 4 1. (acetone) and 7 (sulphuric acid, 75 % m/m) 15. acrylic viscose, cupro, modal or cotton polyester 4 8. (dimethylformamide) and 7. (sulphuric acid, 75 % m/m) 16. acetate wool, hair or silk cotton, viscose, cupro, modal, polyamide or nylon, polyester, acrylic 4 1. (acetone) and 2. (hypochlorite) 17. triacetate wool, hair or silk cotton, viscose, cupro, modal, polyamide or nylon, polyester, acrylic 4 6. (dichloromethane) and 2. (hypochlorite) 18. acrylic wool, hair or silk polyester 1 and/or 4 8. (dimethylformamide) and 2. (hypochlorite) 19. acrylic silk wool or hair 4 8. (dimethylformamide) and 11. (sulphuric acid 75 % m/m) 20. acrylic wool or hair silk cotton, viscose, cupro or modal 1 and/or 4 8. (dimethylformamide) and 2. (hypochlorite) 21. wool, hair or silk cotton, viscose, modal, cupro polyester 4 2. (hypochlorite) and 7. (sulphuric acid 75 % m/m) 22. viscose, cupro or certain types of modal cotton polyester 2 and/or 4 3. (zinc chloride/formic acid) and 7. (sulphuric acid 75 % m/m) 23. acrylic viscose, cupro or certain types of modal cotton 4 8. (dimethylformamide) and 3 (zinc chloride/formic acid) 24. certain chlorofibres viscose, cupro or certain types of modal cotton 1 and/or 4 9. (carbon disulphide/acetone, 55,5/44,5 % v/v) and 3. (zinc chloride/formic acid) or 8. (dimethylformamide) and 3. (zinc chloride/formic acid) 25. acetate viscose, cupro or certain types of modal cotton 4 1. (acetone) and 3. (zinc chloride/formic acid) 26. triacetate viscose, cupro or certain types of modal cotton 4 6. (dichloromethane) and 3. (zinc chloride/formic acid) 27. acetate silk wool or hair 4 1. (acetone) and 11. (sulphuric acid 75 % m/m) 28. triacetate silk wool or hair 4 6. (dichloromethane) and 11. (sulphuric acid 75 % m/m) 29. acetate acrylic cotton, viscose, cupro or modal 4 1. (acetone) and 8. (dimethylformamide) 30. triacetate acrylic cotton, viscose, cupro or modal 4 6. (dichloromethane) and 8. (dimethylformamide) 31. triacetate polyamide or nylon cotton, viscose, cupro or modal 4 6. (dichloromethane) and 4. (formic acid 80 % m/m) 32. triacetate cotton, viscose, cupro or modal polyester 4 6. (dichloromethane) and 7. (sulphuric acid 75 % m/m) 33. acetate polyamide or nylon polyester or acrylic 4 1. (acetone) and 4. (formic acid 80 % m/m) 34. acetate acrylic polyester 4 1. (acetone) and 8. (dimethylformamide) 35. certain chlorofibres cotton, viscose, cupro or modal polyester 4 8. (dimethylformamide) and 7. (sulphuric acid 75 % m/m) or 9 (carbon disulphide/acetone, 55,5/44,5 % v/v) and 7. (sulphuric acid 75 % m/m) 36. cotton polyester elastolefin 2 and/or 4 7. (sulphuric acid 75 % m/m) and 14. (concentrated sulphuric acid) 37. certain modacrylics polyester melamine 2 and/or 4 8. (dimethylformamide) and 14. (concentrated sulphuric acid) (1) In some cases it is necessary to pre-treat the individual test specimen. (2) For made-up and finished articles see point 7. (3) See point 1. (4) The laboratory carder may be replaced by a fibre blender, or the fibres may be mixed by the method of \u2018tufts and rejects\u2019. (5) If the packages can be mounted in a convenient creel a number can be wound simultaneously. (6) Method 12 is an exception. It is based on a determination of the content of a constituent substance of one of the two components. (7) See Chapter 1.1. (8) To ensure that the fibrous residue is immersed in the ammonia solution for 10 minutes, one may, for example, use a filter crucible adaptor fitted with a tap by which the flow of the ammonia solution can be regulated. (9) The solubility of such modacrylics or chlorofibres in the reagent shall be checked before carrying out the analysis. (10) Before carrying out the analysis, the solubility of the polyvinyl chloride fibres in the reagent shall be checked. (11) Wild silks, such as tussah silk, are not completely soluble in 75 % m/m sulphuric acid. (12) These reagents should be nitrogen-free. (13) See for example the apparatus described in Melliand Textilberichte 56 (1975), pp. 643-645. (14) See Chapter 1.1. (15) The values of d are indicated in Chapter 2 of this Annex relating to the various methods of analysing binary mixtures. (16) Wherever possible d3 should be determined in advance by experimental methods. ANNEX IX Agreed allowances used to calculate the mass of fibres contained in a textile product (referred to in Article 19(3)) Fibre No Fibres Percentages 1-2 Wool and animal hair: combed fibres 18,25 carded fibres 17,00 (1) 3 Animal hair: combed fibres 18,25 carded fibres 17,00 (1) Horsehair: combed fibres 16,00 carded fibres 15,00 4 Silk 11,00 5 Cotton: normal fibres 8,50 mercerised fibres 10,50 6 Kapok 10,90 7 Flax (or linen) 12,00 8 True hemp 12,00 9 Jute 17,00 10 Abaca 14,00 11 Alfa 14,00 12 Coir 13,00 13 Broom 14,00 14 Ramie (bleached fibre) 8,50 15 Sisal 14,00 16 Sunn 12,00 17 Henequen 14,00 18 Maguey 14,00 19 Acetate 9,00 20 Alginate 20,00 21 Cupro 13,00 22 Modal 13,00 23 Protein 17,00 24 Triacetate 7,00 25 Viscose 13,00 26 Acrylic 2,00 27 Chlorofibre 2,00 28 Fluorofibre 0,00 29 Modacrylic 2,00 30 Polyamide or nylon: discontinuous fibre 6,25 filament 5,75 31 Aramid 8,00 32 Polyimide 3,50 33 Lyocell 13,00 34 Polylactide 1,50 35 Polyester 1,50 36 Polyethylene 1,50 37 Polypropylene 2,00 38 Polycarbamide 2,00 39 Polyurethane: discontinuous fibre 3,50 filament 3,00 40 Vinylal 5,00 41 Trivinyl 3,00 42 Elastodiene 1,00 43 Elastane 1,50 44 Glass fibre: with an average diameter of over 5 \u03bcm 2,00 with an average diameter of 5 \u03bcm or less 3,00 45 Elastomultiester 1,50 46 Elastolefin 1,50 47 Melamine 7,00 48 Metal fibre 2,00 Metallised fibre 2,00 Asbestos 2,00 Paper yarn 13,75 (1) The agreed allowances of 17,00 % shall also be applied where it is impossible to ascertain whether the textile product containing wool and/or animal hair is combed or carded. ANNEX X Correlation Tables Directive 2008/121/EC This Regulation Article 1(1) Article 4 Article 1(2)(a)-(c) \u2014 Article 1(2)(d) Article 2(3) Article 2(1) Article 3(1) Article 2(2) introductory wording Article 2(2) introductory wording Article 2(2)(a) Article 2(2)(a) Article 2(2)(b) Article 2(2)(b) and (c) Article 2(2)(c) Article 2(2)(d) Article 3 Article 5 Article 4 Article 7 Article 5 Article 8 Article 6(1) and (2) \u2014 Article 6(3) Article 9(3) Article 6(4) Article 9(4) Article 6(5) Article 20 Article 7 Article 10 Article 8(1) first sentence Article 14(1) Article 8(1) second sentence Article 14(2) Article 8(2) Article 14(3) Article 8(3) first subparagraph Article 16(1) Article 8(3) second and third subparagraph Article 16(2) Article 8(4) Article 16(3) Article 8(5) \u2014 Article 9(1) Article 11(1) and (2) Article 9(2) Article 11(3) Article 9(3) Article 13 and Annex IV Article 10(1)(a) Article 17(2) Article 10(1)(b) Article 17(3) Article 10(1)(c) Article 17(4) Article 10(2) Article 17(5) Article 11 Article 15(4) Article 12 Article 19(2) and Annex VII Article 13(1) Article 19(1) Article 13(2) \u2014 Article 14(1) \u2014 Article 14(2) \u2014 Article 15 Article 21 Article 16 \u2014 Article 17 \u2014 Article 18 \u2014 Article 19 \u2014 Article 20 \u2014 Annex I Annex I Annex II Annex III Annex III Annex V Annex III point 36 Article 3(1)(j) Annex IV Annex VI Annex V Annex IX Annex VI \u2014 Annex VII \u2014 Directive 96/73/EC This Regulation Article 1 Article 1 Article 2 Annex VIII Chapter 1 Section I (2) Article 3 Article 19(1) Article 4 Article 19(4) Article 5 Article 21 Article 6 \u2014 Article 7 \u2014 Article 8 \u2014 Article 9 \u2014 Annex I Annex VIII Chapter 1 Section I Annex II Annex VIII Chapter 1 Section II and Chapter 2 Annex III \u2014 Annex IV \u2014 Directive 73/44/EEC This Regulation Article 1 Article 1 Article 2 Annex VIII Chapter 1 Section I Article 3 Article 19(1) Article 4 Article 19(4) Article 5 Article 21 Article 6 \u2014 Article 7 \u2014 Annex I Annex VIII Chapter 3 introduction and Sections I to III Annex II Annex VIII Chapter 3 Section IV Annex III Annex VIII Chapter 3 Section V", "summary": "Textile products: textile fibre names and labelling Textile products: textile fibre names and labelling SUMMARY OF: Regulation (EU) No 1007/2011 \u2013 fibre names labelling and the marking of the fibre composition of textile products SUMMARY WHAT DOES THIS REGULATION DO? It seeks to ensure that EU consumers are properly informed and that the EU clothing and textile market operates smoothly. It lays down rules on textile fibre names with regard to their definition and use when indicating the fibre composition of textile products; the labelling of textile products containing non-textile parts of animal origin; methods of analysis to check information indicated on labels or markings. KEY POINTS The law covers: products exclusively composed of textile fibres and products treated in the same way as textile products, for example products containing at least 80 % by weight of textile fibres. Exclusion: products contracted out to persons working at home, to independent firms or to self-employed tailors. Fibre names The description of fibre composition of textile products must use the textile fibres listed in the regulation\u2019s Annex I. Manufacturers may apply to the European Commission to include a new fibre name in Annex I to the regulation. They must submit a technical file drawn up in line with Annex II which lists minimum requirements. Indication of the composition The use of the terms \u2018100 %\u2019, \u2018pure\u2019 or \u2018all\u2019 is limited to textile products composed of a single textile fibre. The terms \u2018virgin wool\u2019 or \u2018fleece wool\u2019 (and the terms listed in Annex III) may be used on labels only when the product is composed exclusively of a wool fibre which has not previously been incorporated in a finished product, and which has not been subjected to any spinning. Products composed of several fibres must be labelled with the name and percentage by weight of all constituent fibres, in descending order. The presence of non-textile parts of animal origin (for example, a leather strap on a bag made of fabric) in textile products must be indicated by the phrase \u2018Contains non-textile parts of animal origin\u2019. Labelling and marking of textile products If they are to be sold to the consumer, they must be labelled and marked in a durable, legible, visible and accessible way, to indicate their fibre composition. Labelling or marking is the responsibility of those selling the products. For products consisting of two or more textile components not having the same fibre composition, each component\u2019s composition must appear. Labelling must be offered in the official language(s) of the country where the product is sold. Labelling is not required for products listed in Annex V. Market surveillance EU countries\u2019 market surveillance authorities must check the fibre composition of textiles according to the methods in Annex VIII. WHEN DOES THE REGULATION APPLY? It has applied since 8 May 2012. BACKGROUND Textiles and clothing legislation ACT Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (OJ L 272, 18.10.2011, pp. 1\u201364) Successive amendments to Regulation (EU) No 1007/2011 have been incorporated into the basic text. This consolidated version is of documentary value only. last update 30.11.2015"}
{"article": "20.5.2014 EN Official Journal of the European Union L 149/1 REGULATION (EU) No 508/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 42, Article 43(2), Article 91(1), Article 100(2), Article 173(3), Articles 175 and188, Article 192(1), Article 194(2), Article 195(2) and Article 349 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinions of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 13 July 2011 entitled \u2018Reform of the Common Fisheries Policy\u2019 set out the potential challenges, objectives and orientations for the Common Fisheries Policy (\u2018CFP\u2019) after 2013. In the light of the debate that followed the publication of that Communication, the CFP was reformed by Regulation (EU) No 1380/2013 of the European Parliament and of the Council (4). The reform of the CFP covers all the main elements of the CFP, including its financial aspects. In order to attain the objectives of that reform, it is appropriate to repeal Council Regulation (EC) No 2328/2003 (5), Council Regulation (EC) No 861/2006 (6), Council Regulation (EC) No 1198/2006 (7) and Council Regulation (EC) No 791/2007 (8) and to replace them with this Regulation. Recognising that all matters related to Europe\u2019s oceans and seas are interlinked, this Regulation should also support the further development of the Integrated Maritime Policy (IMP) as referred to in Regulation (EU) No 1255/2011 of the European Parliament and of the Council (9). (2) The scope of the European Maritime and Fisheries Fund (EMFF) should include support for the CFP for the conservation of marine biological resources, for the management of fisheries and fleets exploiting those resources, for fresh water biological resources and aquaculture, as well as for the processing and marketing of fishery and aquaculture products, where such activities take place on the territory of Member States, by Union fishing vessels, or by nationals of Member States, without prejudice to the primary responsibility of the flag State, bearing in mind the provisions of Article 117 of the United Nations Convention on the Law of the Sea of 10 December 1982 (10) (UNCLOS). (3) The success of the CFP depends on an effective system of control, inspection and enforcement, as well as on the availability of reliable and complete data, both for scientific advice purposes and for implementation and control purposes. The EMFF should, therefore, support those policies. (4) The scope of the EMFF should include the support for the IMP, including for the development and implementation of coordinated operations and decision-making in relation to the oceans, seas, coastal regions and maritime sectors, complementing the different Union policies relating to them, notably, the CFP, and transport, industry, territorial cohesion, environment, energy and tourism policies. Coherence and integration should be ensured in the management of different sectoral policies within the Baltic Sea, North Sea, Celtic Seas, Bay of Biscay and the Iberian Coast, Mediterranean and Black Sea sea basins. (5) Beneficiaries of the EMFF, within the meaning of point (10) of Article 2 of Regulation (EU) No 1303/2013 of the European Parliament and of the Council (11), can be operators, within the meaning of point (30) of Article 4 of Regulation (EU) No 1380/2013, fishermen or organisations of fishermen, unless otherwise laid down in this Regulation. (6) In accordance with the conclusions of the European Council of 17 June 2010, whereby the Union\u2019s new strategy for jobs and smart, sustainable and inclusive growth, based on the Communication from the Commission of 3 March 2010 entitled \u2018Europe 2020 \u2013 A strategy for smart, sustainable and inclusive growth\u2019 (\u2018Europe 2020 strategy\u2019) was adopted, the Union and Member States should implement smart, sustainable and inclusive growth, while promoting harmonious development in the Union. Resources should be concentrated in order to meet the Europe 2020 strategy objectives and targets, in particular those linked to employment, climate change, energy sustainability, the fight against poverty and social inclusion, and to improve effectiveness by an increased focus on results. The inclusion of the IMP in the EMFF also contributes to the major policy objectives set out in the Europe 2020 strategy and corresponds to the general objectives to increase economic, social and territorial cohesion set out in the Treaty on European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU). (7) To ensure that the EMFF contributes to the achievement of the objectives of the CFP, the IMP and the Europe 2020 strategy, it is necessary to focus on a limited number of core priorities relating to fostering environmentally sustainable, resource efficient, innovative, competitive and knowledge-based fisheries and aquaculture, fostering the implementation of the CFP, increasing employment and territorial cohesion, fostering marketing and processing, as well as fostering the implementation of the IMP. (8) The Union should, at all stages of implementation of the EMFF, aim to eliminate inequalities and promote equality between men and women, as well as to combat discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation. (9) The overall objective of the CFP is to ensure that fishing and aquaculture activities contribute to the creation of environmental conditions capable of being sustained long-term which are necessary for economic and social development. Moreover, it should contribute to increased productivity, a fair standard of living for the fisheries sector and stable markets, and it should ensure the availability of resources and that supplies reach consumers at reasonable prices. (10) It is paramount to better integrate environmental concerns into the CFP which should achieve the objectives and targets of the Union\u2019s environmental policy and the Europe 2020 strategy. The CFP seeks to achieve an exploitation of living marine biological resources that restores fish stocks to and maintains them above levels which can produce the maximum sustainable yield, by 2015, where possible, and at the latest by 2020. The CFP should implement the precautionary and eco-system approaches to fisheries management. Consequently, the EMFF should contribute to the protection of the marine environment as set out in Directive 2008/56/EC of the European Parliament and of the Council (12). (11) The financing of the CFP and IMP expenditure through a single fund, the EMFF, should address the need for simplification and should strengthen the integration of both policies. The extension of shared management to processing and marketing, including compensation for the outermost regions, control, data collection and management activities and to the IMP, should further contribute to simplifying and reducing the administrative burden both for the Commission and Member States as well as to achieving a greater coherence and efficiency of the support granted. (12) The Union budget should finance the CFP and the IMP expenditure through a single fund, the EMFF, either directly or in the context of shared management with Member States. Shared management with Member States should apply not only to measures to support fisheries, aquaculture and community-led local development, but also to processing and marketing, compensation for the outermost regions, control and data collection activities as well as the IMP. Direct management should apply to scientific advice, specific control and enforcement measures, voluntary contributions to regional fisheries management organisations, Advisory Councils, market intelligence, operations for the implementation of the IMP and communication activities. The types of operations that qualify for financing under the EMFF should be specified. (13) It is necessary to distinguish between categories of control and enforcement measures that are co-financed within the framework of shared management, and those co-financed within the framework of direct management. It is crucial to ring-fence the resources to be allocated to control and data collection under shared management whilst allowing flexibility between those two categories of measures. (14) In accordance with Regulation (EU) No 1380/2013, Union financial support under EMFF is to be made conditional upon compliance by Member States and by operators with the rules of the CFP. This requirement is intended to reflect the responsibility of the Union to ensure, in the public interest, the conservation of marine biological resources under the CFP pursuant to Article 3 TFEU. (15) The achievement of the objectives of the CFP would be undermined if Union financial support under the EMFF were disbursed to operators who, ex ante, did not comply with requirements related to the public interest of conservation of marine biological resources. Therefore, applications submitted by operators should only be admissible for funding under the EMFF on the condition that, within a particular period of time before submitting an application for support, the operators concerned have not committed a serious infringement, offence or fraud and have not been involved in the operation, management or ownership of fishing vessels included in the Union list of vessels engaged in illegal, unreported and unregulated (IUU) fishing or of vessels flagged to countries identified as non-cooperating third countries as set out in this Regulation. (16) In addition, the beneficiaries, after submitting the application for support, should continue to comply with those admissibility requirements throughout the period of implementation of the operation and for a period of five years after the final payment to the beneficiary concerned. (17) If the beneficiary fails to fulfil the conditions related to eligibility and duration, financial consequences and corrections should apply. In order to determine the amount of such a financial correction, the nature, gravity, duration and repetition of the infringement, offence or fraud by the beneficiary and the importance of the EMFF contribution to the economic activity of the beneficiary should be taken into account. (18) The achievement of the objectives of the CFP would also be undermined if Union financial support under the EMFF were paid to Member States who did not comply with their obligations under the CFP rules related to the public interest of conservation of marine biological resources, such as data collection and the implementation of control obligations. Moreover, if those obligations are not complied with, there is a risk that inadmissible applications or ineligible operations will not be detected by Member States. (19) As a precautionary measure, in order to prevent ineligible payments as well as to provide an incentive for Member States to comply with the CFP rules, provision should be made for the interruption of the payment deadline and the suspension of payments, measures which are limited in time and in their scope of application. Financial corrections which have definite and irrevocable consequences should only apply to expenditure which is affected by the cases of non-compliance. (20) In order to improve the coordination and to harmonise the implementation of the Funds providing support under the cohesion policy, namely the European Regional Development Fund (ERDF), the European Social Fund (ESF) and the Cohesion Fund (CF), with the Funds for rural development and for the maritime and fisheries sector, namely the European Agricultural Fund for Rural Development (EAFRD) and the EMFF respectively, common provisions for all those Funds (\u2018ESI Funds\u2019) have been established in Regulation (EU) No 1303/2013. In addition to Regulation (EU) No 1303/2013, this Regulation contains specific, complementary provisions due to the particularities of the CFP and the IMP sectors. (21) The principle of proportionality should be applied to the operational programme and throughout the programme cycle, taking into account the size of the Member States\u2019 respective administrations and the total amount of public expenditure allocated to the operational programme. (22) The Commission should break down the available commitment appropriations annually by Member State using objective and transparent criteria. Those criteria should include indicators measuring the size of the fishery and aquaculture sector, the extent of control and data collection responsibilities, the historical allocations in accordance with Regulation (EC) No 1198/2006 and the historical consumption in accordance with Regulation (EC) No 861/2006. (23) The fulfilment of certain specific ex ante conditionalities is of utmost importance in the context of the CFP, especially as regards the submission of a report on fishing capacity and of a multiannual national strategic plan on aquaculture and the proven administrative capacity to comply with the data requirements for fisheries management and to enforce the implementation of a Union control, inspection and enforcement system. (24) In accordance with the aim of simplification, all activities under the EMFF which fall under shared management, including control and data collection, should take the form of a single operational programme per Member State, in accordance with the national structure of the Member State concerned. The programming exercise should cover the period from 1 January 2014 to 31 December 2020. When preparing the single operational programme, Member States should ensure that the content and volume of their operational programmes reflect the aim of simplification. Each programme should identify a strategy for meeting targets in relation to the Union priorities under the EMFF and a selection of measures. Programming should comply with those Union priorities, while adapting to national contexts, and should complement other Union policies, in particular the rural development policy and the cohesion policy. (25) With a view to promoting small\u2013scale coastal fishing, Member States having a significant small\u2013 scale coastal fishing segment should attach, to their operational programmes, action plans for the development, competitiveness and sustainability of small-scale coastal fishing. (26) In order to contribute to achieving the aim of simplification while implementing the EMFF and to reduce the costs of control and the error rate, Member States should make as much use as possible of the possibility to use simplified forms of grants as provided for in Regulation (EU) No 1303/2013. (27) For the purpose of enforcing control obligations under the CFP, Member States should draw up the section on control of the operational programme in accordance with the priorities of the Union adopted by the Commission for that policy area. In order to adjust the operational programme to the evolving needs in relation to control and enforcement, the control section of the operational programmes should be reviewed regularly on the basis of the changes in the priorities of the Union in the control and enforcement policy under the CFP. Those amendments should be approved by the Commission. In order to keep flexibility in the programming of activities in the field of control, the revision of the control section of the operational programmes should be subject to a simplified procedure. (28) Member States should draw up the section on data collection of the operational programme in accordance with the Union multiannual programme as referred to in Council Regulation (EC) No 199/2008 (13). In order to adapt to the specific needs of data collection activities, Member States should, in accordance with that Regulation, draw up a work plan, which should be subject to approval by the Commission. (29) Funds under direct management, with the exception of technical assistance by the Commission, should be pre-defined by objectives with a 5 % flexibility margin and be governed by annual work programmes. (30) In order to increase the competitiveness and economic performance of fishing activities, it is vital to stimulate and to provide support for investment in innovation. In order to encourage a higher level of participation, the application procedure for support for innovation should be simplified. (31) Investment in human capital is also vital to increase the competitiveness and economic performance of fishing and maritime activities. Therefore, the EMFF should support advisory services, cooperation between scientists and fishermen, professional training, lifelong learning, and should stimulate the dissemination of knowledge, help to improve the overall performance and competitiveness of operators and promote social dialogue. In recognition of their role in fishing communities, spouses and life partners of self-employed fishermen should, under certain conditions, also be granted support for professional training, lifelong learning and the dissemination of knowledge, and for networking that contributes to their professional development. (32) In order to help young people experiencing difficulties in accessing the labour market in the fisheries sector during a time of persistent financial crisis, the EMFF should support traineeship programmes and courses on sustainable fishing practices and the conservation of marine biological resources. (33) Conscious of the potential that diversification offers for small\u2013scale coastal fishermen and their crucial role in coastal communities, the EMFF should provide support for investments contributing to the diversification of the income of fishermen through the development of complementary activities, including investments on board, angling tourism, restaurants, environmental services related to fishing and educational activities on fishing. (34) The creation and development of new economic activities in the fisheries sector by young fishermen is financially challenging and constitutes an element that should be considered in the allocation and targeting of funds under the EMFF. Such development is essential for the competitiveness of the fisheries sector in the Union. Consequently, support for young fishermen starting up their fisheries activities should be established in order to facilitate their initial establishment. In order to ensure the viability of new economic activities supported under the EMFF, support should be made conditional upon the acquisition of the necessary skills and competencies. Support for business start\u2013up should only contribute to the acquisition of the first fishing vessel. (35) In order to address health and safety needs on board, the EMFF should support investments covering safety, working conditions, health and hygiene on board, provided that the investment supported goes beyond requirements under Union or national law. (36) Rules should be laid down for granting allowances and financial compensation to fishermen and owners of fishing vessels in cases of temporary cessation of fishing activities, if such cessation is the direct consequence of certain conservation measures, excluding the fixing and allocation of fishing opportunities, is provided for in certain Union or national fisheries\u2019 management plans, or results from the non-renewal of Sustainable fisheries partnership agreements or protocols thereto. Such rules should also be laid down in cases of permanent cessation of fishing activities. (37) It should be possible, under certain conditions, for the EMFF to contribute to mutual funds which provide financial compensation to fishermen for economic losses caused by adverse climatic events, an environmental incident or rescue costs. (38) In order to adapt fishing activities to fishing opportunities, it should be possible for the EMFF to support the design, development, monitoring, evaluation and management of systems for the allocation of fishing opportunities. (39) It is of paramount importance to integrate environmental concerns into the EMFF and to support the implementation of conservation measures under the CFP, whilst taking into account the diverse conditions throughout Union waters. For that purpose, it is essential to develop a regionalised approach to conservation measures. (40) Similarly, it should be possible for the EMFF to support the reduction of the impact of fishing on the marine environment, in particular through the promotion of eco- innovation and the use of more selective gears and equipment as well as through measures aimed at protecting and restoring marine biodiversity and ecosystems and the services they provide, in accordance with the \u2018EU Biodiversity Strategy to 2020\u2019. (41) In accordance with the headline target of the Europe 2020 strategy related to mitigation of climate change and energy efficiency, it should be possible for the EMFF to support investments on board and energy audits. (42) In order to mitigate the effects of climate change and improve the energy efficiency of fishing vessels, it should be possible to grant support to the modernisation and replacement of main and ancillary engines, provided that operators active in small\u2013scale coastal fishing are given priority in the selection process in order to improve their access to financing, and provided that larger vessels contribute to the reduction of engine power. (43) In order not to jeopardise the sustainability objective of the CFP reform, the amount of financial support that may be dedicated to fleet measures, such as temporary and permanent cessation as well as engine replacement, should be capped, and the period of time during which such financial support may be granted for permanent cessation should be limited. (44) In accordance with the discard ban introduced by the CFP, the EMFF should support investments on board aimed at making the best use of unwanted fish caught and exploiting underused components of the fish caught. In view of the scarcity of the resources, and in order to maximise the value of the fish caught, the EMFF should also support investments on board aimed at adding commercial value to the fish caught. (45) Conscious of the importance of fishing ports, landing sites and shelters, the EMFF should support relevant investments that aim, in particular, to increase energy efficiency, environmental protection, the quality of the products landed, and to improve safety and working conditions. (46) It is vital for the Union that a sustainable balance be achieved between fresh water resources and their exploitation. Therefore, having due regard to the impact on the environment, while preserving the economic viability of those sectors, appropriate measures should be provided for to support inland fishing. (47) In accordance with the Communication from the Commission to the Council and the European Parliament of 19 September 2002 entitled \u2018A Strategy for the sustainable development of European aquaculture\u2019 and the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 29 April 2013 entitled \u2018Strategic guidelines for the sustainable development of EU aquaculture\u2019, the CFP objectives and the Europe 2020 strategy, the EMFF should support the environmentally, economically and socially sustainable development of the aquaculture industry. (48) Due to the potential impact on wild marine populations of escapes of farmed animals from aquaculture sites, the EMFF should not provide incentives for the farming of genetically modified organisms. (49) Aquaculture contributes to growth and jobs in coastal and rural regions. Therefore, it is crucial that the EMFF is accessible to aquaculture enterprises, in particular small and medium-sized enterprises (SMEs), and that it contributes to bringing new aquaculture farmers into the business. In order to increase the competitiveness and economic performance of aquaculture activities, it is vital to stimulate innovation and entrepreneurship. Therefore, it should be possible for the EMFF to support innovative operations, the business development of aquaculture enterprises in general, including non\u2013food and off\u2013shore aquaculture, and complementary activities such as angling-tourism, environmental services related to aquaculture or educational activities. (50) Investment in human capital is also vital to increase the competitiveness and economic performance of aquaculture activities. Therefore, it should be possible for the EMFF to support lifelong learning and networking stimulating the dissemination of knowledge, as well as advisory services helping to improve the overall performance and competitiveness of operators. (51) In order to contribute to the development of aquaculture sites and infrastructures, it should be possible for the EMFF to support national and regional authorities in their strategic choices, in particular as regards the definition and mapping of the zones which may be considered to be most suited to the development of aquaculture. (52) In order to promote environmentally, socially and economically sustainable aquaculture, it should be possible for the EMFF to support aquaculture activities which highly respect the environment, the conversion of aquaculture enterprises to eco-management, the use of audit schemes as well as the conversion to organic aquaculture. Similarly, it should be possible for the EMFF to also support aquaculture which provides special environmental services. (53) Conscious of the importance of consumer protection, it should be possible for the EMFF to provide adequate support to farmers in order to prevent and mitigate the risk for public and animal health that aquaculture rearing may cause. (54) Recognizing the risk of investments in aquaculture activities, it should be possible for the EMFF to promote business security by contributing to aquaculture stock insurance, thereby safeguarding the income of producers in case of abnormal production losses due, in particular, to natural disasters, adverse climatic events, sudden water quality changes, diseases or pest infestations and the destruction of production facilities. (55) Given that the community\u2013led approach for local development has, over a number of years, proven its utility in promoting the development of fisheries and aquaculture as well as rural areas by fully taking into account the multisectoral needs for endogenous development, support should be continued and reinforced in the future. (56) In the fishery and aquaculture sector, community-led local development should encourage innovative approaches to create growth and jobs, in particular by adding value to fishery products and diversifying the local economy towards new economic activities, including those offered by \u2018blue growth\u2019 and the broader maritime sectors. (57) The sustainable development of the fishery and aquaculture sector should contribute to achieving the objectives of the Europe 2020 Strategy of promoting social inclusion and poverty reduction, creating jobs and fostering innovation, at local level. It should also contribute to achieving the objective of territorial cohesion which is one of the main priorities of the TFEU. (58) Community-led local development should be implemented through a bottom-up approach by local partnerships that are composed of representatives of the public, private and civil society sectors and that reflect correctly the local society. Those local actors are best placed to draw up and implement multisectoral community-led local development strategies to meet the needs of their local fisheries area. It is important to ensure that no single interest group has more than 49 % of the voting rights in the decision-making bodies of Fisheries local action groups (FLAGs). (59) Networking between local partnerships is an essential feature of that approach. Cooperation between local partnerships is therefore an important development tool which should be supported by the EMFF. (60) The support to fisheries areas through the EMFF should be coordinated with the local development support offered by other Union Funds, and should cover all aspects of the preparation and implementation of community-led local development strategies and operations of FLAGs as well as the costs of animating the local area and running the local partnership. (61) In order to ensure the viability of fisheries and aquaculture in a highly competitive market, it is necessary to lay down provisions granting support for the implementation of Regulation (EU) No 1379/2013 of the European Parliament and of the Council (14), and for marketing and processing activities carried out by operators to maximise the value of fishery and aquaculture products. Particular attention should be paid to the promotion of operations which integrate producing, processing and marketing activities of the supply chain, or which consist of innovative processes or methods. Priority should be given to producer organisations and associations of producer organisations when granting support. In the case of production and marketing plans, only such organisations and associations should be eligible for support. In order to adapt to the new discard ban policy, the EMFF should also support the processing of unwanted catches. (62) Regulation (EU) No 1379/2013 provides for a storage mechanism for fishery products intended for human consumption with a view to fostering the stabilisation of the markets. In order to ensure a transition from market intervention mechanisms to a new focus on the planning and management of production and marketing activities, any support granted by the EMFF should end by 31 December 2018. (63) Recognising the growing competition that small\u2013scale coastal fishermen are confronted with, it should be possible for the EMFF to support entrepreneurial initiatives of small\u2013scale coastal fishermen that add value to the fish they catch, in particular by carrying out the processing or direct marketing of such fish. (64) Given that fishing activities in the outermost regions of the Union are facing difficulties, in particular because of their remoteness and special climatic conditions, it should be possible for the EMFF to take into account the particular constraints of such regions, recognised in Article 349 TFEU. (65) In order to maintain the competitiveness of certain fishery and aquaculture products from the outermost regions of the Union compared to that of similar products from other regions of the Union, the Union introduced measures in 1992 to compensate for the related additional costs in the fisheries sector. The measures that apply for the period 2007-2013 are laid down in Regulation (EC) No 791/2007. It is necessary to continue to provide support in order to offset the additional costs for the fishing, farming, processing and marketing of certain fishery and aquaculture products from the outermost regions of the Union as from 1 January 2014, so that the compensation contributes to the retaining of the economic viability of operators from those regions. (66) In view of the different marketing conditions in the outermost regions, the fluctuations in captures and stocks and of market demands, it should be left to the Member States concerned to determine the fishery products eligible for compensation, their respective maximum quantities and the compensation amounts, within the overall allocation per Member State. (67) Member States should be authorised to differentiate the list and the quantities of fishery products concerned and the amount of compensation within the overall allocation per Member State. They should also be authorised to adjust their compensation plans if justified by changing conditions. (68) Member States should set the compensation amount at a level which allows appropriate off-setting of additional costs, arising from the specific handicaps of the outermost regions. To avoid overcompensation, that amount should be proportionate to the additional costs that the aid off sets. For that purpose, it should also take into account other types of public intervention having an impact on the level of additional costs. (69) It is of paramount importance that Member States and operators have the means necessary to carry out controls to a high standard, thereby ensuring compliance with the rules of the CFP, while providing for the sustainable exploitation of living aquatic resources. It should therefore be possible for the EMFF to support Member States and operators in accordance with Council Regulation (EC) No 1224/2009 (15). By creating a culture of compliance, that support should contribute to sustainable growth. (70) The support granted to Member States on the basis of Regulation (EC) No 861/2006 in respect of expenditure incurred in relation to the implementation of the Union control system should be increased under the EMFF, thereby pursuing the logic of a single fund. (71) In accordance with the Union control and enforcement policy objectives, it is appropriate that a minimum time is dedicated to fisheries control in the usage of patrol vessels, aircrafts and helicopters, which should be set out precisely in order to provide a basis for support under the EMFF. (72) Considering the importance of cooperation between Member States in the field of control, it should be possible for the EMFF to provide support for that purpose. (73) Measures should be adopted which support the collection, management and use of fisheries data as specified in the multiannual Union programme, in particular to support national programmes and the management and use of data for scientific analysis and CFP implementation. The support granted to Member States on the basis of Regulation (EC) No 861/2006 for the expenditure incurred relating to the collection, management and use of fisheries data should be continued under the EMFF, thereby pursuing the logic of a single fund. (74) Sound and efficient fisheries management decisions under the CFP should be supported by research and cooperation activities, by the provision of scientific and socio\u2013economic opinions and by the advice needed for the implementation and development of the CFP, including in biogeographically sensitive areas. (75) It is also necessary to support the cooperation between Member States, as well as with third countries where relevant, with respect to the collection of data within the same sea basin, as well as with the relevant international scientific bodies. (76) The objective of the IMP is to support the sustainable use of seas and oceans and to develop coordinated, coherent and transparent decision-making in relation to the policies affecting the oceans, seas, islands, coastal and outermost regions and maritime sectors, as reflected in Commission Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 10 October 2007 entitled \u2018An Integrated Maritime Policy of the European Union\u2019. (77) Sustained funding is needed for the implementation and further development of the IMP for the Union as reflected in Regulation (EU) No 1255/2011, in the conclusions of the Council, in European Parliament resolutions and in opinions of the Committee of the Regions. The development of maritime affairs through financial support for IMP measures is expected to have a significant impact in terms of economic, social and territorial cohesion. (78) The EMFF should support the promotion of integrated maritime governance at all levels, especially through exchanges of best practices and the further development and implementation of sea basin strategies. Those strategies aim to set up an integrated framework to address common challenges in European sea basins, to strengthen cooperation between stakeholders to maximise the use of Union financial instruments and funds, and to contribute to the economic, social and territorial cohesion of the Union. In that context, actions and mechanisms targeting improved cooperation between Member States may include cross-border and cross-sectoral cooperation between maritime sectors, for example, activities within the framework of the European coastguard functions forum, to promote the exchange of experiences and best practices in order to achieve effectiveness and coherence within the framework of existing relevant Union law. (79) The EMFF should support the further development of tools to create synergies between initiatives taken in different sectors and affecting the seas, oceans and coasts. This is the case for the Integrated Maritime Surveillance (IMS), which aims to improve awareness of the maritime situation through enhanced and secure information exchanges across sectors. However, operations related to maritime surveillance falling within the scope of Title V of Part Three, TFEU should not be financed through the EMFF. (80) The interconnection of information systems run by those sectors may make it necessary to mobilise the funding mechanisms of those systems in a coherent way and in accordance with the TFEU. Maritime spatial planning and integrated coastal zone management are essential for the sustainable development of marine areas and coastal regions, and both contribute to the aims of an ecosystem-based management and the development of land-sea links. Those tools are also important in managing the diverse uses of our coasts, seas and oceans to enable their sustainable economic development and to stimulate cross-border investment, whereas the implementation of Directive 2008/56/EC will further define the boundaries of sustainability of human activities that have an impact on the marine environment. Furthermore, it is necessary to improve knowledge of the marine world, and to stimulate innovation by facilitating the collection, free sharing, re-use and dissemination of data concerning the status of oceans and seas. (81) The EMFF should support sustainable economic growth, employment, innovation and competitiveness within maritime sectors and in coastal regions. It is particularly important to identify regulatory barriers and skill deficiencies hindering growth in emerging and prospective maritime sectors, as well as operations aimed at fostering investment in technological innovation that are necessary to enhance the business potential of marine and maritime applications. (82) The EMFF should be complementary to, and coherent with, existing and future financial instruments made available by the Union and Member States, at national and sub-national level, for promoting sustainable economic, social and territorial development, the protection and sustainable use of the oceans, seas and coasts, helping to foster more effective cooperation between Member States and their coastal, island, and outermost regions, and taking into account the prioritisation and progress of national and local projects. The EMFF should tie in with other Union policies that are capable of having a maritime dimension, in particular the ERDF, the CF and the ESF, as well as the Horizon 2020 Programme established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council (16). (83) In order to achieve the objectives of the CFP at global level, the Union plays an active role in the work of international organisations. It is therefore essential that the Union contributes to the activities of such organisations that help to ensure the conservation and sustainable exploitation of fisheries resources on the high seas and in third country waters. The support granted to international organisations on the basis of Regulation No (EC) 861/2006 should be continued under the EMFF, thereby pursuing the logic of a single fund. (84) In order to improve governance within the CFP and to ensure the effective functioning of the Advisory Councils, it is essential for Advisory Councils to be provided with sufficient and permanent funding in order to pursue effectively their advisory role within the CFP. Pursuing the logic of a single fund, the support granted to Advisory Councils under the EMFF should replace the support granted to Regional Advisory Councils on the basis of Regulation (EC) No 861/2006. (85) By means of technical assistance, the EMFF should facilitate the implementation of operational programmes, inter alia, by promoting innovative approaches and practices that are capable of simple and transparent implementation. Technical assistance should also include the setting\u2013up of a European network of FLAGs aimed at capacity building, disseminating information, exchanging experience and supporting cooperation between local partnerships. (86) In the interest of a good working partnership and the proper promotion of Union assistance, provision should be made for the broadest possible information on, and publicity about, Union support. The authorities responsible for managing assistance should also be responsible for such information and publicity aspects, and for keeping the Commission informed of measures taken in that regard. (87) In relation to all operations financed under this Regulation, both under shared and direct management, it is necessary to ensure the protection of the financial interests of the Union by means of the proper application of the relevant legislation relating to the protection of those interests, and to ensure that appropriate controls are carried out by Member States and by the Commission. (88) In order to address the specific conditions of the CFP referred to in Regulation (EU) No 1380/2013 and to contribute to the compliance with CFP rules, provisions additional to the rules on interruption of the payment deadline as set out in Regulation (EU) No 1303/2013should be laid down. Where a Member State or an operator has failed to comply with its obligations under the CFP, or where the Commission has evidence that suggests such a lack of compliance, the Commission should, as a precautionary measure, be allowed to interrupt payment deadlines. (89) In addition to the possibility of interruption of the payment deadline, and in order to avoid an evident risk of paying out ineligible expenditure, the Commission should be allowed to suspend payments in cases of serious non-compliance with the CFP rules by a Member State. (90) Operational programmes should be subject to monitoring and evaluation in order to improve their quality and to demonstrate their achievements. The Commission should set up a framework for a common monitoring and evaluation system ensuring, inter alia, that relevant data is made available in a timely manner. In that context, a list of indicators should be determined and the impact of the EMFF policy should be assessed by the Commission in relation to specific objectives. (91) Responsibility for monitoring the implementation of an operational programme should be shared between the managing authority and the monitoring committee set up for that purpose. To this end, the respective responsibilities of the managing authority and the monitoring committee should be specified. The monitoring of an operational programme should involve the drawing up of an annual implementation report, which should be sent to the Commission. (92) With a view to improving accessibility to, and transparency of, information about funding opportunities and project beneficiaries, a single website or website portal providing information on the operational programme, including the lists of operations supported under the operational programme, should be made available in each Member State. The dedicated websites of all Member States should also be accessible from a single official Union website in order to facilitate the access of citizens from different Member States to information published by all Member States. That information should be reasonable, clear and concrete, to give the wider public and, in particular, Union taxpayers, an understanding of how Union funding is spent in the framework of the EMFF. In addition to that objective, the publication of relevant data should serve to further publicise the possibility of applying for Union funding. Without prejudice to the application of Directive 95/46/EC of the European Parliament and of the Council (17), such publication may include the names of natural persons in accordance with national law. (93) In order to supplement and amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the identification of the period of time and of the relevant starting or ending dates of the period of time with regard to the admissibility criteria of applications, adjusting the percentages concerning the indicative distribution of funds among the objectives under direct management, the definition of eligible operations and costs for hygiene, health and safety-related investments and investments concerning working conditions, on board or in individual equipment, the definition of eligible costs of operations to protect and restore marine biodiversity and ecosystems in the framework of sustainable fishing activities, the definition of costs eligible for support with regard to investments in equipment or on board aimed at reducing the emission of pollutants or green-house gases and increasing the energy efficiency of fishing vessels, the definition of the criteria for calculation of the additional costs resulting from the specific handicaps of outermost regions, the definition of the cases of non-compliance by Member States which can trigger interruption of the payment deadline or suspension of payments, the definition of the criteria for establishing the level of financial correction to be applied and the criteria for applying flat rates or extrapolated financial corrections and the definition of the content and construction of the common monitoring and evaluation system. (94) In order to facilitate a smooth transition from the scheme established by Regulation (EC) No 1198/2006 to the scheme established by this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of establishing transitional provisions. (95) When adopting delegated acts under this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (96) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of setting out the annual breakdown, by Member State, of the global resources available for commitments in the framework of shared management approving the operational programmes and their amendments, approving the work plans for data collection, adopting the annual work programmes relating to technical assistance at the initiative of the Commission, recognising that there is evidence suggesting non-compliance with obligations under the CFP, recognising that a Member State has failed to comply with its obligations under the CFP, suspending all or part of the interim payments under the operational programme and making financial corrections by cancelling all or part of the Union support for an operational programme. The Commission should adopt those implementing acts without applying Regulation (EU) No 182/2011 of the European Parliament and of the Council (18). (97) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should also be conferred on the Commission in respect of the presentation of the elements of the operational programme, rules on procedures, format and timetables concerning the approval of, and the submission and approval of amendments to, operational programmes, the annual work programme under Chapters I and II of Title VI, the structure of the compensation plan for outermost regions, the application of the different percentage points of public aid intensity, the model to be used by Member States when submitting financial data to the Commission, setting the indicators specific to the Union priorities, rules on the information to be sent by Member States as well as on the data needs and synergies between potential data sources, the format and presentation of the annual implementation reports, and the elements to be included in the ex ante evaluation reports. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 and the examination procedure should be used. (98) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should, moreover, be conferred on the Commission in respect of the adoption of, and detailing any changes in, the actual priorities of the Union for enforcement and control, laying down rules for the presentation of the data provided by the managing authorities, technical characteristics of information and publicity measures for the operation and instructions for creating the emblem and a definition of the standard colours. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. In order to ensure a simpler and faster procedure, the advisory procedure should be used. (99) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States given the structural problems encountered in the development of the fisheries, aquaculture and maritime sectors as well as the limited financial resources of Member States, but can rather, by reason of the scale and effects of the operations to be financed under the operational programmes, be better achieved at Union level by providing multiannual financial support focused on the relevant priorities, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (100) The support scheme provided for in this Regulation replaces the support schemes set up by Regulation (EC) No 2328/2003, Regulation (EC) No 861/2006, Regulation (EC) No 1198/2006, Regulation (EC) No 791/2007, Regulation (EU) No 1255/2011 and Article 103 of Regulation (EC) No 1224/2009. Those regulations and that provision should therefore be repealed with effect from 1 January 2014. However, this Regulation should not affect either the continuation or modification of assistance approved by the Commission on the basis of Regulation (EC) No 1198/2006 or any other legislation applying to that assistance on 31 December 2013. (101) It is appropriate to align the period of application of this Regulation with that of Regulation (EU) No 1303/2013. Therefore, this Regulation should apply as from 1 January 2014, HAVE ADOPTED THIS REGULATION: TITLE I SUBJECT-MATTER, SCOPE AND DEFINITIONS Article 1 Subject-matter This Regulation defines Union financial measures for the implementation of: (a) the Common Fisheries Policy (CFP); (b) relevant measures relating to the Law of the Sea; (c) the sustainable development of fisheries and aquaculture areas and inland fishing; and (d) the Integrated Maritime Policy (IMP). Article 2 Geographical scope This Regulation applies to operations carried out in the territory of the Union, unless otherwise provided for in this Regulation. Article 3 Definitions 1. For the purposes of this Regulation and without prejudice to paragraph 2 of this Article, the definitions referred to in Article 4 of Regulation (EU) No 1380/2013, Article 5 of Regulation (EU) No 1379/2013, Article 4 of Regulation (EC) No 1224/2009 and Article 2 of Regulation (EU) No 1303/2013 apply. 2. For the purpose of this Regulation, the following definitions apply: (1) \u2018Common information sharing environment\u2019 (CISE) means a network of systems with a decentralised set-up developed for the exchange of information between users in order to improve their situational awareness of activities at sea; (2) \u2018cross-sectoral operations\u2019 means those initiatives that mutually benefit different sectors and/or sectoral policies, as referred to in the TFEU, and that cannot be accomplished entirely through measures encompassed within respective policy areas; (3) \u2018electronic recording and reporting system\u2019 (ERS) means a system for the electronic recording and reporting of data as referred to in Regulation (EC) No 1224/2009; (4) \u2018European marine observation and data network\u2019 means a network that integrates relevant national marine observation and data programmes into a common and accessible European resource; (5) \u2018fisheries and aquaculture area\u2019 means an area with a sea, river or lake shore, including ponds or a river basin, with a significant level of employment in fisheries or aquaculture, that is functionally coherent in geographical, economic and social terms and is designated as such by a Member State; (6) \u2018fisherman\u2019 means any person engaging in commercial fishing activities, as recognised by the Member State; (7) \u2018inland fishing\u2019 means fishing activities carried out for commercial purposes in inland waters by vessels or other devices, including those used for ice fishing; (8) \u2018integrated coastal zone management\u2019 means strategies and measures such as those described in Recommendation 2002/413/EC of the European Parliament and of the Council (19); (9) \u2018integrated maritime governance\u2019 means the coordinated management of all sectoral policies at Union level affecting the oceans, seas and coastal regions; (10) \u2018Integrated Maritime Policy\u2019 (IMP) means a Union policy whose aim is to foster coordinated and coherent decision-making to maximise the sustainable development, economic growth and social cohesion of Member States, and notably the coastal, insular and outermost regions in the Union, as well as maritime sectors, through coherent maritime-related policies and relevant international cooperation; (11) \u2018Integrated maritime surveillance\u2019 (IMS) means a Union initiative aimed at enhancing effectiveness and efficiency in surveillance activities in respect of the European seas through information exchange and collaboration across sectors and borders; (12) \u2018maritime spatial planning\u2019 means a process by which the relevant Member State\u2019s authorities analyse and organise human activities in marine areas in order to achieve ecological, economic and social objectives; (13) \u2018measure\u2019 means a set of operations; (14) \u2018small\u2013scale coastal fishing\u2019 means fishing carried out by fishing vessels of an overall length of less than 12 metres and not using towed fishing gear as listed in Table 3 of Annex I to Commission Regulation (EC) No 26/2004 (20); (15) \u2018vessels operating exclusively in inland waters\u2019 means vessels engaged in commercial fishing in inland waters and not included in the Union fishing fleet register. TITLE II GENERAL FRAMEWORK CHAPTER I Establishment and objectives of the European Maritime and Fisheries Fund Article 4 Establishment The European Maritime and Fisheries Fund (EMFF) is hereby established. Article 5 Objectives The EMFF shall contribute to the achievement of the following objectives: (a) promoting competitive, environmentally sustainable, economically viable and socially responsible fisheries and aquaculture; (b) fostering the implementation of the CFP; (c) promoting a balanced and inclusive territorial development of fisheries and aquaculture areas; (d) fostering the development and implementation of the Union\u2019s IMP in a manner complementary to cohesion policy and to the CFP. The pursuit of those objectives shall not result in an increase in fishing capacity. Article 6 Union priorities The EMFF shall contribute to the Europe 2020 strategy and to the implementation of CFP. It shall pursue the following Union priorities for the sustainable development of fisheries and aquaculture and related activities, which reflect the relevant thematic objectives referred to in Regulation (EU) No 1303/2013: (1) Promoting environmentally sustainable, resource\u2013efficient, innovative, competitive and knowledge\u2013based fisheries by pursuing the following specific objectives: (a) the reduction of the impact of fisheries on the marine environment, including the avoidance and reduction, as far as possible, of unwanted catches; (b) the protection and restoration of aquatic biodiversity and ecosystems; (c) the ensuring of a balance between fishing capacity and available fishing opportunities; (d) the enhancement of the competitiveness and viability of fisheries enterprises, including of small\u2013scale coastal fleet, and the improvement of safety and working conditions; (e) the provision of support to strengthen technological development and innovation, including increasing energy efficiency, and knowledge transfer; (f) the development of professional training, new professional skills and lifelong learning. (2) Fostering environmentally sustainable, resource-efficient, innovative, competitive and knowledge-based aquaculture by pursuing the following specific objectives: (a) the provision of support to strengthen technological development, innovation and knowledge transfer; (b) the enhancement of the competitiveness and viability of aquaculture enterprises, including the improvement of safety and working conditions, in particular of SMEs; (c) the protection and restoration of aquatic biodiversity and the enhancement of ecosystems related to aquaculture and the promotion of resource-efficient aquaculture; (d) the promotion of aquaculture having a high level of environmental protection, and the promotion of animal health and welfare and of public health and safety; (e) the development of professional training, new professional skills and lifelong learning. (3) Fostering the implementation of the CFP by pursuing the following specific objectives: (a) the improvement and supply of scientific knowledge as well as the improvement of the collection and management of data; (b) the provision of support to monitoring, control and enforcement, thereby enhancing institutional capacity and the efficiency of public administration, without increasing the administrative burden. (4) Increasing employment and territorial cohesion by pursuing the following specific objective: the promotion of economic growth, social inclusion and job creation, and providing support to employability and labour mobility in coastal and inland communities which depend on fishing and aquaculture, including the diversification of activities within fisheries and into other sectors of maritime economy. (5) Fostering marketing and processing by pursuing the following specific objectives: (a) the improvement of market organisation for fishery and aquaculture products; (b) the encouragement of investment in the processing and marketing sectors. (6) Fostering the implementation of the IMP. CHAPTER II Shared and direct management Article 7 Shared and direct management 1. Measures covered by Title V shall be financed by the EMFF in accordance with the principle of shared management between the Union and Member States and the common rules laid down in Regulation (EU) No 1303/2013. 2. Measures covered by Title VI shall be financed by the EMFF in accordance with the principle of direct management. CHAPTER III General Principles of Assistance under Shared Management Article 8 State aid 1. Without prejudice to paragraph 2 of this Article, Articles 107, 108 and 109 TFEU shall apply to aid granted by Member States to undertakings in the fishery and aquaculture sector. 2. However, Articles 107, 108 and 109 TFEU shall not apply to payments made by Member States pursuant to, and in conformity with, this Regulation falling within the scope of Article 42 TFEU. 3. National provisions setting up public financing going beyond the provisions of this Regulation concerning payments referred to in paragraph 2, shall be treated as a whole on the basis of paragraph 1. 4. For the fishery and aquaculture products, listed in Annex I TFEU, to which Articles 107, 108 and 109 thereof apply, the Commission may authorise, in accordance with Article 108 TFEU, operating aid in the outermost regions referred to in Article 349 TFEU within the sectors producing, processing and marketing fishery and aquaculture products, with a view to alleviating the specific constraints in those regions as a result of their isolation, insularity and extreme remoteness. Article 9 Specific ex ante conditionalities The specific ex ante conditionalities referred to in Annex IV shall apply to the EMFF. CHAPTER IV Admissibility of applications and ineligible operations Article 10 Admissibility of applications 1. An application submitted by an operator for support from the EMFF shall be inadmissible for an identified period of time laid down pursuant to paragraph 4 of this Article, if it has been determined by the competent authority that the operator concerned: (a) has committed a serious infringement under Article 42 of Council Regulation (EC) No 1005/2008 (21) or Article 90(1) of Regulation (EC) No 1224/2009; (b) has been involved in the operation, management or ownership of fishing vessels included in the Union IUU vessel list as set out in Article 40(3) of Regulation (EC) No 1005/2008, or of vessels flagged to countries identified as non-cooperating third countries as set out in Article 33 of that Regulation; (c) has committed a serious infringement of the CFP rules identified as such in other legislation adopted by the European Parliament and by the Council; or (d) has committed any of the offences set out in Articles 3 and 4 of Directive 2008/99/EC of the European Parliament and of the Council (22), where the application is made for support under Chapter II of Title V of this Regulation. 2. The beneficiary, after submitting the application, shall continue to comply with the conditions referred to in points (a) to (d) of paragraph 1 throughout the period of implementation of the operation and for a period of five years after the final payment to that beneficiary. 3. An application submitted by an operator shall be inadmissible for an identified period of time laid down pursuant to paragraph 4 of this Article, if it has been determined by the competent authority that that operator has committed a fraud, as defined in Article 1 of the Convention on the protection of the European Communities\u2019 financial interests (23), in the context of the European Fisheries Fund (EFF) or the EMFF. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 126 concerning: (a) the identification of the period of time referred to in paragraphs 1 and 3 of this Article which shall be proportionate to the nature, gravity, duration and repetition of the serious infringement, offence or fraud, and shall be of at least one year\u2019s duration; (b) the relevant starting or ending dates of the period of time referred to in paragraphs 1 and 3 of this Article. 5. Member States shall require that operators submitting an application under the EMFF provide to the managing authority a signed statement confirming that they respect the criteria listed in paragraph 1 of this Article and declaring that they have not committed a fraud under the EFF or the EMFF as referred to in paragraph 3 of this Article. Member States shall verify the veracity of that statement before approving the operation, based on the information available in the national register of infringements referred to in Article 93 of Regulation (EC) No 1224/2009, or any other available data. For the purposes of the first subparagraph, a Member State shall provide, on request from another Member State, the information contained in its national register of infringements referred to in Article 93 of Regulation (EC) No 1224/2009. Article 11 Ineligible operations The following operations shall not be eligible under the EMFF: (a) operations increasing the fishing capacity of a vessel or equipment increasing the ability of a vessel to find fish; (b) the construction of new fishing vessels or the importation of fishing vessels; (c) the temporary or permanent cessation of fishing activities, unless otherwise provided for in this Regulation; (d) exploratory fishing; (e) the transfer of ownership of a business; (f) direct restocking, unless explicitly provided for as a conservation measure by a Union legal act or in the case of experimental restocking. TITLE III FINANCIAL FRAMEWORK Article 12 Budget implementation 1. The Union budget allocated to the EMFF under Title V of this Regulation shall be implemented within the framework of shared management in accordance with Article 4 of Regulation (EU) No 1303/2013. 2. The Union budget allocated to the EMFF under Title VI of this Regulation shall be implemented directly by the Commission in accordance with Article 58(1)(a) of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (24). 3. Any cancellations of all or part of the budget commitment under direct management by the Commission shall comply with Regulation (EU, Euratom) No 966/2012 and, where appropriate, with Article 123 of this Regulation. 4. The principle of sound financial management shall be applied in accordance with Articles 30 and 53 of Regulation (EU, Euratom) No 966/2012. Article 13 Budgetary resources under shared management 1. The resources available for commitments from the EMFF for the period from 2014 to 2020 under shared management shall be EUR 5 749 331 600 in current prices in accordance with the annual breakdown set out in Annex II. 2. EUR 4 340 800 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the sustainable development of fisheries, aquaculture and fisheries areas, to marketing and processing-related measures and to technical assistance at the initiative of the Member States under Chapters I, II, III, IV and VII of Title V, with the exception of Article 67. 3. EUR 580 000 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the control and enforcement measures referred to in Article 76. 4. EUR 520 000 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the measures on data collection referred to in Article 77. 5. EUR 192 500 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the compensation of outermost regions under Chapter V of Title V. That compensation shall not exceed, per year: (a) EUR 6 450 000 for the Azores and Madeira; (b) EUR 8 700 000 for the Canary Islands; (c) EUR 12 350 000 for the French outermost regions referred to in Article 349 TFEU. 6. EUR 44 976 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the storage aid referred to in Article 67. 7. EUR 71 055 600 of the budgetary resources referred to in paragraph 1 shall be allocated to measures concerning the IMP referred to in Chapter VIII of Title V. 8. Member States shall have the possibility to use interchangeably the resources available under paragraphs 3 and 4. Article 14 Budgetary resources under direct management 1. The resources available for commitments from the EMFF, for the period 2014 to 2020, concerning measures under direct management as specified in Chapters I to III of Title VI shall be EUR 647 275 400 in current prices. 2. For the purposes of Chapters I and II of Title VI, the indicative distribution of funds between the objectives set out in Articles 82 and 85, is set out in Annex III. 3. The Commission may depart from the indicative percentages referred to in paragraph 2 by no more than 5 % of the value of the financial envelope in each case. 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 126, adjusting the percentages set out in Annex III. Article 15 Mid-term review The Commission shall review the implementation of Chapter I and II of Title VI, including the need for adjustments of the indicative distribution of funds as laid down in Annex III, and shall, by 30 June 2017, submit to the European Parliament and to the Council an interim evaluation report on the results obtained and the qualitative and quantitative aspects of the EMFF. Article 16 Financial distribution for shared management 1. The resources available for commitments by Member States referred to in Article 13(2) to (7) for the period from 2014 to 2020, as set out in the table in Annex II, shall be determined on the basis of the following objective criteria: (a) as regards Title V, with the exception of Articles 76 and 77: (i) the level of employment in the fisheries and marine and fresh water aquaculture sectors, including employment in related processing; (ii) the level of production in the fisheries and marine and fresh water aquaculture sectors, including related processing; and (iii) the share of small\u2013scale coastal fishing fleet in the overall fishing fleet; (b) as regards Articles 76 and 77: (i) the extent of the control tasks of the Member State concerned, taking into account the size of the national fishing fleet and the size of the sea area to be controlled, the volume of the landings and the value of imports from third countries; (ii) the available control resources compared to the extent of the control tasks of the Member State, where available means are determined by taking into account the number of controls conducted at sea and the number of landing inspections; (iii) the extent of the data collections tasks of the Member State concerned, taking into account the size of the national fishing fleet, the volume of the landings and of the aquaculture production, the amount of scientific monitoring activities at sea and the number of surveys the Member State is taking part in; and (iv) the available data collection resources compared to the extent of the data collection tasks of the Member State, where available means are determined by taking into account the human resources and technical means needed to implement the national sampling programme for data collection; (c) as regards all measures, the historical allocations of funds in accordance with Regulation (EC) No 1198/2006 and the historical consumption in accordance with Regulation (EC) No 861/2006. 2. The Commission shall adopt implementing acts setting out the annual breakdown of the global resources per Member State. TITLE IV PROGRAMMING CHAPTER I Programming for measures financed under shared management Article 17 Preparation of operational programmes 1. Each Member State shall draw up a single operational programme to implement the Union priorities set out in Article 6 which are to be co\u2013financed by the EMFF. 2. The operational programme shall be established by the Member State following close cooperation with the partners referred to in Article 5 of Regulation (EU) No 1303/2013. 3. For the section of the operational programme referred to in point (o) of Article 18(1), the Commission shall, by 31 May 2014, adopt implementing acts laying down the actual priorities of the Union for enforcement and control policy. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 127(2). Article 18 Content of the operational programme 1. In addition to the elements referred to in Article 27 of Regulation (EU) No 1303/2013, the operational programme shall include: (a) an analysis of the situation in terms of the strengths, weaknesses, opportunities and threats and the identification of the needs that require to be addressed in the geographical area, including, where relevant, sea basins covered by the programme. The analysis shall be structured around the relevant Union priorities set out in Article 6 of this Regulation and, where applicable, shall be consistent with the multiannual national strategic plan for aquaculture referred to in Article 34 of Regulation (EU) No 1380/2013 and the progress made in achieving good environmental status through the development and implementation of a marine strategy referred to in Article 5 of Directive 2008/56/EC. Specific needs concerning jobs, the environment, the mitigation of, and adaptation to, climate change, and the promotion of innovation shall be assessed in relation to the Union priorities, with a view to identifying the most relevant responses at the level of each of the priorities related to the relevant area; (b) a description of the strategy within the meaning of Article 27 of Regulation (EU) No 1303/2013, which shall demonstrate that: (i) appropriate targets are set for each of the Union priorities that are included in the programme, on the basis of common indicators referred to in Article 109 of this Regulation; (ii) the selection of relevant measures follows logically from each Union priority selected in the programme, taking into account the conclusions of the ex ante evaluation and the analysis referred to in point (a) of this paragraph. As regards the measures for the permanent cessation of fishing activities under Article 34 of this Regulation, the description of the strategy shall include the targets and measures to be taken for the reduction of the fishing capacity in accordance with Article 22 of Regulation (EU) No 1380/2013. A description of the method for the calculation of the compensation to be granted under Articles 33 and 34 of this Regulation shall also be included; (iii) the allocation of financial resources to the Union priorities included in the programme is justifiable and adequate to achieve the targets set; (c) where appropriate, the specific needs of Natura 2000 areas, as established by Council Directive 92/43/EEC (25), and the contribution of the programme to the establishment of a coherent network of fish stock recovery areas as provided for in Article 8 of Regulation (EU) No 1380/2013; (d) the assessment of the specific ex ante conditionalities referred to in Article 9 of and in Annex IV to this Regulation and, where required, the actions referred to in Article 19(2) of Regulation (EU) No 1303/2013; (e) a description of the performance framework within the meaning of Article 22 of and Annex II to Regulation (EU) No 1303/2013; (f) a list of measures selected organised by Union priorities; (g) a list of criteria applied for selecting the fisheries and aquaculture areas under Chapter III of Title V; (h) a list of selection criteria for community-led local development strategies under Chapter III of Title V; (i) in Member States where over 1 000 vessels can be considered small-scale coastal fishing vessels, an action plan for the development, competitiveness and sustainability of small-scale coastal fishing; (j) the evaluation requirements and the evaluation plan referred to in Article 56 of Regulation (EU) No 1303/2013 and actions to be taken to address identified needs; (k) a financing plan which is to be designed by taking into account Article 20 of Regulation (EU) No 1303/2013 and in accordance with the Commission implementing act referred to in Article 16(2) of this Regulation, comprising: (i) a table setting out the total EMFF contribution planned for each year; (ii) a table setting out the applicable EMFF resources and co-financing rate under the Union priorities set out in Article 6 of this Regulation and for technical assistance; by way of derogation from the general rule laid down in Article 94(2) of this Regulation, that table shall, where applicable, indicate separately the EMFF resources and the co-financing rates which apply for the support referred to in Articles 33, 34, Article 41(2), Articles 67 and 70, points (a) to (d) and (f) to (l) of Article 76(2), point (e) of Article 76(2) and Article 77 of this Regulation; (l) information on the complementarity and coordination with ESI Funds and other relevant Union and national funding instruments; (m) implementing arrangements of the operational programme including: (i) identification of the authorities referred to in Article 123 of Regulation (EU) No 1303/2013 and, for information purposes, a summary describing the management and control system; (ii) a description of the respective roles of the FLAGs, the managing authority or designated body for all implementation tasks relating to the community-led local development strategy; (iii) a description of the monitoring and evaluation procedures, as well as the general composition of the monitoring committee referred to in Article 48 of Regulation (EU) No 1303/2013; (iv) the provisions to ensure that the programme is publicised in accordance with Article 119 of this Regulation; (n) a list of the partners referred to in Article 5 of Regulation (EU) No 1303/2013 and the results of the consultation of those partners; (o) for the objective of ensuring increased compliance through control referred to in Article 6(3)(b), and in accordance with the actual priorities adopted by the Commission pursuant to Article 17(3): (i) a list of the bodies implementing the control, inspection and enforcement system and a brief description of their human and financial resources available for fisheries control, inspection and enforcement, and their major equipment available for fisheries control, inspection and enforcement, in particular the number of vessels, aircraft and helicopters; (ii) the overall objectives of the control measures to be implemented, using common indicators to be set in accordance with Article 109; (iii) specific objectives to be achieved in accordance with the Union priorities set out in Article 6 and a detailed indication by category over the entire programming period; (p) for the objective of collection of data for sustainable fisheries management referred to in point (a) of Article 6(3), and in accordance with the multiannual Union programme referred to in Article 3 of Regulation (EC) No 199/2008: (i) a description of the activities of data collection, in accordance with Article 25(1) of Regulation (EU) No 1380/2013; (ii) a description of the data storage methods, data management and data use; (iii) a description of the capability to achieve sound financial and administrative management of the data collected. The section of the operational programme referred to in point (p) shall be supplemented in accordance with Article 21 of this Regulation. 2. The operational programme shall include the methods for calculating the simplified costs referred to in points (b), (c) and (d) of Article 67(1) of Regulation (EU) No 1303/2013 and additional costs or income foregone in accordance with Article 96 of this Regulation, and the method for calculating compensation in accordance with relevant criteria identified for each of the activities deployed under Article 40(1), Articles 53, 54 and 55, point (f) of Article 56(1) and Article 67 of this Regulation. Where relevant, information on advance payments to FLAGs under Article 62 of this Regulation shall also be included. 3. The Commission shall adopt implementing acts laying down rules for the presentation of the elements described in paragraphs 1 and 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3). Article 19 Approval of the operational programme 1. Subject to Article 29 of Regulation (EU) No 1303/2013, the Commission shall adopt implementing acts approving the operational programme. 2. For the purpose of adopting the implementing acts referred to in paragraph 1 of this Article, the Commission shall examine whether the measures referred to in point (b)(ii) of Article 18(1) are likely to effectively remove the overcapacity identified. Article 20 Amendment of the operational programme 1. The Commission shall adopt implementing acts approving any amendments to an operational programme 2. In order to adapt to the evolving needs of control, the Commission may, every two years, adopt implementing acts detailing any changes in the priorities of the Union in the enforcement and control policy as referred to in Article 17(3) and the corresponding eligible operations which are to be prioritised. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 127(2). 3. Member States may submit an amendment to their operational programme, taking into account new priorities laid down in implementing acts referred to in paragraph 2 of this Article. In accordance with the principle of proportionality, such amendments to the operational programme shall be subject to a simplified procedure to be adopted in accordance with Article 22(2). Article 21 Work plans for data collection 1. For the purpose of application of point (p) of Article 18(1) of this Regulation, Member States shall submit to the Commission by electronic means work plans for data collection in accordance with Article 4(4) of Regulation (EC) No 199/2008 by 31 October of the year preceding the year from which the work plan is to apply, unless an existing plan still applies, in which case they shall notify the Commission thereof. The content of those plans shall be consistent with Article 4(2) of that Regulation. 2. The Commission shall adopt implementing acts approving the work plans referred to in paragraph 1 by 31 December of the year preceding the year from which the work plan is to apply. Article 22 Rules on procedures and timetables 1. The Commission may adopt implementing acts laying down rules on procedures, format and timetables for: (a) the approval of operational programmes; (b) the submission and approval of amendments to operational programmes, including their entry into force and frequency of submission during the programming period; (c) the submission and approval of amendments as referred to in Article 20(3); (d) the submission of work plans for data collection. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3). 2. The procedures and timetables shall be simplified in the case of: (a) amendments to operational programmes concerning a transfer of funds between Union priorities, provided that the funds transferred do not exceed 10 % of the amount allocated to the Union priority; (b) amendments to operational programmes concerning the introduction or withdrawal of measures or types of relevant operations and related information and indicators; (c) amendments to operational programmes concerning changes in the description of measures, including changes of eligibility conditions; (d) amendments referred to in Article 20(3), as well as in the case of any other amendments to the section of the operational programme referred to in point (n) of Article 18(1). 3. Paragraph 2 shall not apply to measures referred to in Articles 33, 34 and Article 41(2). CHAPTER II Programming for measures financed under direct management Article 23 Annual work programme 1. In order to implement Title VI, the Commission shall adopt implementing acts laying down annual work programmes in accordance with the objectives set out in the respective Chapters. For Chapters I and II of Title VI, those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3). 2. The annual work programmes shall include: (a) a description of the activities to be financed and the objectives to be pursued for each activity which shall be in accordance with the objectives laid down in Articles 82 and 85. It shall also contain an indication of the amount allocated to each activity, an indicative implementation timetable, as well as information on their implementation; (b) for grants and related measures, the essential evaluation criteria, which shall be set in a manner that best achieves the objectives pursued by the operational programme, and the maximum rate of co-financing. TITLE V MEASURES FINANCED UNDER SHARED MANAGEMENT CHAPTER I Sustainable development of fisheries Article 24 Specific objectives Support under this Chapter shall contribute to the achievement of the specific objectives under the Union priority set out in Article 6(1). Article 25 General conditions 1. The owner of a fishing vessel having received support under this Chapter shall not transfer that vessel outside the Union during at least the five years following the date of actual payment of that support to the beneficiary. If a vessel is transferred within that time\u2013frame, sums unduly paid in respect of the operation shall be recovered by the Member State, in an amount proportionate to the period during which the condition set out in the first sentence of this paragraph has not been fulfilled. 2. Operating costs shall not be eligible unless otherwise expressly provided for in this Chapter. 3. The total financial contribution from the EMFF to the measures referred to in Articles 33 and 34 and to the replacement or modernisation of main or ancillary engines referred to in Article 41, shall not exceed the higher of the following two thresholds: (a) EUR 6 000 000; or (b) 15 % of the Union financial support allocated by the Member State to the Union priorities set out in Article 6(1), (2) and (5). 4. The total financial contribution from the EMFF to the measures referred to in Article 29(4) shall not exceed 5 % of the Union financial support allocated per Member State. 5. Support to vessel owners granted under Article 33 shall be deducted from support granted to vessel owners under Article 34 for the same vessel. Article 26 Innovation 1. In order to stimulate innovation in fisheries, the EMFF may support projects aimed at developing or introducing new or substantially improved products and equipment, new or improved processes and techniques, and new or improved management and organisation systems, including at the level of processing and marketing. 2. Operations financed under this Article shall be carried out by, or in collaboration with, a scientific or technical body, recognised by the Member State or the Union. That scientific or technical body shall validate the results of such operations. 3. The results of operations financed under this Article shall be adequately publicised by the Member State in accordance with Article 119. Article 27 Advisory services 1. In order to improve the overall performance and competitiveness of operators and to promote sustainable fisheries, the EMFF may support: (a) feasibility studies and advisory services that assess the viability of projects potentially eligible for support under this Chapter; (b) the provision of professional advice on environmental sustainability, with a focus on limiting and, where possible, eliminating the negative impact of fishing activities on marine, terrestrial and freshwater ecosystems; (c) the provision of professional advice on business and marketing strategies. 2. The feasibility studies, advisory services and advice referred to in paragraph 1 shall be provided by scientific, academic, professional or technical bodies, or entities providing economic advice that have the required competences. 3. The support referred to in paragraph 1 shall be granted to operators, organisations of fishermen, including producer organisations, or public law bodies. 4. Where the support referred to in paragraph 1 does not exceed the amount of EUR 4 000, the beneficiary may be selected by means of an accelerated procedure. Article 28 Partnerships between scientists and fishermen 1. In order to foster the transfer of knowledge between scientists and fishermen, the EMFF may support: (a) the creation of networks, partnership agreements or associations between one or more independent scientific bodies and fishermen, or one or more organisations of fishermen, in which technical bodies may participate; (b) the activities carried out in the framework of the networks, partnership agreements, or associations referred to in point (a). 2. The activities referred to in point (b) of paragraph 1 may cover data collection and management activities, studies, pilot projects, dissemination of knowledge and research results, seminars and best practices. 3. The support referred to in paragraph 1 may be granted to public law bodies, fishermen, organisations of fishermen, FLAGs and non-governmental organisations. Article 29 Promotion of human capital, job creation and social dialogue 1. In order to promote human capital, job creation and social dialogue, the EMFF may support: (a) professional training, lifelong learning, joint projects, the dissemination of knowledge of an economic, technical, regulatory or scientific nature and of innovative practices, and the acquisition of new professional skills, in particular linked to the sustainable management of marine ecosystems, hygiene, health, safety, activities in the maritime sector, innovation and entrepreneurship; (b) networking and exchange of experiences and best practices between stakeholders, including among organisations promoting equal opportunities between men and women, promoting the role of women in fishing communities and promoting under-represented groups involved in small-scale coastal fishing or in on-foot fishing; (c) social dialogue at Union, national, regional or local level involving fishermen, social partners and other relevant stakeholders. 2. The support referred to in paragraph 1 may also be granted to spouses of self-employed fishermen or, where and in so far as recognised by national law, the life partners of self-employed fishermen, under the conditions laid down in point (b) of Article 2 of Directive 2010/41/EU of the European Parliament and of the Council (26). 3. The support referred to in point (a) of paragraph 1 may be granted, for a maximum period of two years, for the training of people under 30 years of age, who are recognised as unemployed by the Member State concerned (\u2018trainees\u2019). Such support shall be limited to training on board a small\u2013scale coastal fishing vessel owned by a professional fisherman of at least 50 years of age, formalised by a contract between the trainee and the owner of the vessel that is recognised by the Member State concerned, including courses on sustainable fishing practices and the conservation of marine biological resources as defined in Regulation (EU) No 1380/2013. The trainee shall be accompanied on board by a professional fisherman of at least 50 years of age. 4. Support under paragraph 3 shall be granted to professional fishermen to cover the trainee\u2019s salary and related charges, and shall be calculated in accordance with Article 67(5) of Regulation (EU) No 1303/2013, taking into account the economic situation and living standards of the Member State concerned. That support shall not exceed a maximum amount of EUR 40 000 for each beneficiary during the programming period. Article 30 Diversification and new forms of income 1. The EMFF may support investments contributing to the diversification of the income of fishermen through the development of complementary activities, including investments on board, angling tourism, restaurants, environmental services related to fishing and educational activities concerning fishing. 2. The support under paragraph 1 shall be granted to fishermen who: (a) submit a business plan for the development of their new activities; and (b) possess adequate professional skills which may be acquired through operations financed under point (a) of Article 29(1). 3. The support under paragraph 1 shall only be granted if the complementary activities relate to the fisherman\u2019s core fishing business. 4. The amount of support granted under paragraph 1 shall not exceed 50 % of the budget foreseen in the business plan for each operation, and shall not exceed a maximum amount of EUR 75 000 for each beneficiary. Article 31 Start-up support for young fishermen 1. The EMFF may provide business start-up support to young fishermen. 2. Support under this Article may be granted only in respect of the first acquisition of a fishing vessel: (a) with an overall length of less than 24 metres; (b) which is equipped for sea fishing; (c) which is between 5 and 30 years old; and (d) which belongs to a fleet segment for which the report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown a balance with the fishing opportunities available to that segment. 3. For the purpose of this Article, the term \u2018young fisherman\u2019 means a natural person who seeks to acquire a fishing vessel for the first time and who, at the moment of submitting the application, is under 40 years of age and who has worked for at least five years as fisherman, or has acquired equivalent vocational training. Member States may define further objective criteria to be met by young fishermen in order to be eligible for support under this Article. 4. The support under this Article shall not exceed 25 % of the acquisition cost of the fishing vessel and shall in any event not be higher than EUR 75 000 per young fisherman. Article 32 Health and safety 1. In order to improve hygiene, health, safety and working conditions for fishermen, the EMFF may support investments on board or in individual equipment provided that those investments go beyond the requirements under Union or national law. 2. The support under this Article shall be granted to fishermen or owners of fishing vessels. 3. Where the operation consists of an investment on board, the support shall not be granted more than once during the programming period for the same type of investment and for the same fishing vessel. Where the operation consists of an investment in individual equipment, the support shall not be granted more than once during the programming period for the same type of equipment and for the same beneficiary. 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 126, identifying the types of operations eligible under paragraph 1 of this Article. Article 33 Temporary cessation of fishing activities 1. The EMFF may support measures for temporary cessation of fishing activities in the following cases: (a) the implementation of Commission measures or Member States emergency measures referred to in Articles 12 and 13, respectively, of Regulation (EU) No 1380/2013 or of conservation measures referred to in Article 7 of that Regulation, including biological recovery periods; (b) a non-renewal of Sustainable fisheries partnership agreements or protocols thereto; (c) where the temporary cessation is provided for in a management plan adopted in accordance with Council Regulation (EC) No 1967/2006 (27) or in a multiannual plan adopted under Articles 9 and 10 of Regulation (EU) No 1380/2013, where, based on scientific advice, a reduction of fishing effort is needed in order to achieve the objectives referred to in Article 2(2) and point (a) of Article 2(5) of Regulation (EU) No 1380/2013. 2. The support referred to in paragraph 1 may be granted for a maximum duration of six months per vessel during the period from 2014 to 2020. 3. The support referred to in paragraph 1 shall only be granted to: (a) owners of Union fishing vessels which are registered as active and which have carried out fishing activities at sea for at least 120 days during the last two calendar years preceding the date of submission of the application for support; or (b) fishermen who have worked at sea for at least 120 days during the last two calendar years preceding the date of submission of the application for support on board a Union fishing vessel concerned by the temporary cessation. 4. All fishing activities carried out by the fishing vessel or by the fishermen concerned shall be effectively suspended. The competent authority shall satisfy itself that the fishing vessel concerned has stopped any fishing activities during the period concerned by the temporary cessation. Article 34 Permanent cessation of fishing activities 1. The EMFF may support measures for the permanent cessation of fishing activities only when that is achieved through the scrapping of fishing vessels and provided that: (a) such scrapping is included in the operational programme referred to in Article 18; and (b) the permanent cessation is foreseen as a tool of an action plan referred to in Article 22(4) of Regulation (EU) No 1380/2013 indicating that the fleet segment is not effectively balanced with the fishing opportunities available to that segment. 2. Support under paragraph 1 shall be granted to: (a) owners of Union fishing vessels registered as active and which have carried out fishing activities at sea for at least 90 days per year during the last two calendar years preceding the date of submission of the application for support; or (b) fishermen who have worked at sea for at least 90 days per year during the last two calendar years preceding the date of submission of the application for support, on board of a Union fishing vessel concerned by the permanent cessation. 3. The fishermen concerned shall effectively cease all fishing activities. The beneficiary shall provide proof of the effective cessation of fishing activities to the competent authority. The compensation shall be refunded on a pro rata temporis basis where the fisherman returns to a fishing activity within a period of less than two years from the date of submission of the application for support. 4. Support under this Article may be granted until 31 December 2017. 5. Support under this Article shall be paid only after the equivalent capacity has been permanently removed from the Union fishing fleet register and after the fishing licences and authorisations have also been permanently withdrawn. The beneficiary shall be prohibited from registering a new fishing vessel within five years following the receipt of such support. The decrease in capacity as a result of the permanent cessation of fishing activities with public aid shall result in the permanent equivalent reduction of the fishing capacity ceilings set out in Annex II to Regulation (EU) No 1380/2013. 6. By way of derogation from paragraph 1, support may be granted for the permanent cessation of fishing activities without scrapping provided that the vessels retrofit for activities other than commercial fishing. In addition and with a view to preserving maritime heritage, support may be granted for the permanent cessation of fishing activities without scrapping in the case of traditional wooden vessels, provided that such vessels retain a land-based heritage function. Article 35 Mutual funds for adverse climatic events and environmental incidents 1. The EMFF may contribute to mutual funds which pay financial compensation to fishermen for economic losses caused by adverse climatic events or by environmental incidents or for the rescue costs for fishermen or fishing vessels in the case of accidents at sea during their fishing activities. 2. For the purpose of paragraph 1, the term \u2018mutual fund\u2019 means a scheme accredited by the Member State, in accordance with its national law, which enables affiliated fishermen to insure themselves, whereby compensation payments are made to affiliated fishermen for economic losses caused by the events set out in paragraph 1. 3. Member States shall ensure that overcompensation as a result of the combination of the support under this Article with other Union or national instruments or private insurance schemes is avoided. 4. In order to be eligible for support under this Article, the mutual fund concerned shall: (a) be accredited by the competent authority of the Member State, in accordance with national law; (b) have a transparent policy towards payments into and withdrawals from the fund; and (c) have clear rules attributing responsibility for any debts incurred. 5. Member States shall define the rules for the establishment and management of the mutual funds, in particular for the granting of compensation payments and the eligibility of fishermen for such compensation in the event of adverse climatic events, environmental incidents or accidents at sea referred to in paragraph 1, as well as for the administration and monitoring of compliance with those rules. Member States shall ensure that the fund arrangements provide for penalties in the case of negligence on the part of the fisherman. 6. Adverse climatic events, environmental incidents or accidents at sea referred to in paragraph 1 shall be those that are formally recognised by the competent authority of the Member State concerned as having occurred. 7. The contributions referred to in paragraph 1 shall only relate to the amounts paid by the mutual fund as financial compensation to fishermen. The administrative costs of setting-up the mutual funds shall not be eligible for support. Member States may limit the costs that are eligible for support by applying ceilings per mutual fund. 8. The contributions referred to in paragraph 1 shall only be granted to cover losses caused by the adverse climatic events, environmental incidents or accidents at sea which amount to more than 30 % of the annual turnover of the business concerned, calculated on the basis of the average turnover of that business over the preceding three calendar years. 9. No contribution from the EMFF shall be made to the initial capital stock. 10. Where Member States decide to limit the costs that are eligible for support by applying ceilings per mutual fund, they shall provide details and justifications in their operational programmes on those ceilings. Article 36 Support for the systems of allocation of fishing opportunities 1. In order to adapt the fishing activities to the fishing opportunities, the EMFF may support the design, development, monitoring, evaluation and management of the systems for allocating the fishing opportunities. 2. Support under this Article shall be granted to public authorities, legal or natural persons or organisations of fishermen recognised by the Member State, including recognised producer organisations involved in the collective management of the systems referred to in paragraph 1. Article 37 Support for the design and implementation of conservation measures and regional cooperation 1. In order to ensure the efficient design and implementation of conservation measures under Articles 7, 8 and 11 of Regulation (EU) No 1380/2013 and regional cooperation under Article 18 of that Regulation, the EMFF may support: (a) the design, development and monitoring of technical and administrative means necessary for the development and implementation of conservation measures and regionalisation; (b) stakeholder participation and cooperation between Member States in designing and implementing conservation measures and regionalisation. 2. The EMFF may support direct restocking under paragraph 1 only when it is provided for as a conservation measure in a Union legal act. Article 38 Limitation of the impact of fishing on the marine environment and adaptation of fishing to the protection of species 1. In order to reduce the impact of fishing on the marine environment, to foster the gradual elimination of discards and to facilitate the transition to a sustainable exploitation of living marine biological resources in accordance with Article 2(2) of Regulation (EU) No 1380/2013, the EMFF may support investments: (a) in equipment improving size selectivity or species selectivity of fishing gear; (b) on board or in equipment that eliminates discards by avoiding and reducing unwanted catches of commercial stocks, or that deals with unwanted catches to be landed in accordance with Article 15 of Regulation (EU) No 1380/2013; (c) in equipment that limits and, where possible, eliminates the physical and biological impacts of fishing on the ecosystem or the sea bed; (d) in equipment that protects gear and catches from mammals and birds protected by Council Directive 92/43/EEC or Directive 2009/147/EC of the European Parliament and of the Council (28), provided that it does not undermine the selectivity of the fishing gear and that all appropriate measures are introduced to avoid physical damage to the predators. 2. By way of derogation from point (a) of Article 11, in the outermost regions the support referred to in paragraph 1 may be granted for anchored fish aggregating devices, provided that such devices contribute to sustainable and selective fishing. 3. Support shall not be granted more than once during the programming period for the same type of equipment on the same Union fishing vessel. 4. Support shall only be granted where the gear or other equipment referred to in paragraph 1 has a demonstrably better size-selection or a demonstrably lower impact on the ecosystem and on non-target species than the standard gear or other equipment permitted under Union law, or under relevant national law adopted in the context of regionalisation as provided for in Regulation (EU) No 1380/2013. 5. Support shall be granted to: (a) owners of Union fishing vessels which are registered as active vessels and which have carried out fishing activities at sea of at least 60 days during the two calendar years preceding the date of submission of the application for support; (b) fishermen who own the gear to be replaced and who have worked on board of a Union fishing vessel for at least 60 days during the two calendar years preceding the date of submission of the application for support; (c) organisations of fishermen recognised by the Member State. Article 39 Innovation linked to the conservation of marine biological resources 1. In order to contribute to the gradual elimination of discards and by\u2013catches and to facilitate the transition to exploitation of living marine biological resources in accordance with Article 2(2) of Regulation (EU) No 1380/2013, and to reduce the impact of fishing on the marine environment and the impact of protected predators, the EMFF may support operations aimed at developing or introducing new technical or organisational knowledge that reduces the impact of fishing activities on the environment, including improved fishing techniques and gear selectivity, or aimed at achieving a more sustainable use of marine biological resources and coexistence with protected predators. 2. Operations financed under this Article shall be carried out by, or in collaboration with, a scientific or technical body recognised by the Member State which shall validate the results of such operations. 3. The results of operations financed under this Article shall be adequately publicised by the Member State in accordance with Article 119. 4. Fishing vessels involved in projects financed under this Article shall not exceed 5 % of the number of vessels of the national fleet or 5 % of the national fleet tonnage in gross tonnage, calculated at the time of submission of the application. At the request of a Member State, in duly justified circumstances and on the basis of a recommendation by the Scientific, Technical and Economic Committee for Fisheries (STECF) established by Commission Decision 2005/629/EC (29), the Commission may approve projects that exceed the limits set out in this paragraph. 5. Operations which do not qualify as fishing for scientific purposes in accordance with Article 33 of Regulation (EC) No 1224/2009 and which consist of testing new fishing gear or techniques shall be carried out within the limits of the fishing opportunities allocated to the Member State concerned. 6. The net revenue generated by the participation of the fishing vessel in the operation shall be deducted from the eligible expenditure of the operation in accordance with Article 65(8) of Regulation (EU) No 1303/2013. 7. For the purpose of paragraph 6, the term \u2018net revenue\u2019 means the income of fishermen from the first sale of the fish or shellfish caught during the introduction and testing of the new technical or organisational knowledge less the selling costs such as auction hall fees. Article 40 Protection and restoration of marine biodiversity and ecosystems and compensation regimes in the framework of sustainable fishing activities 1. In order to protect and restore marine biodiversity and ecosystems in the framework of sustainable fishing activities, with the participation, where relevant, of fishermen, the EMFF may support the following operations: (a) the collection of waste by fishermen from the sea such as the removal of lost fishing gear and marine litter; (b) the construction, installation or modernisation of static or movable facilities intended to protect and enhance marine fauna and flora, including their scientific preparation and evaluation; (c) contributions to a better management or conservation of marine biological resources; (d) the preparation, including studies, drawing-up, monitoring and updating of protection and management plans for fishery-related activities relating to NATURA 2000 sites and spatial protected areas referred to in Directive 2008/56/EC and relating to other special habitats; (e) the management, restoration and monitoring of NATURA 2000 sites in accordance with Directives 92/43/EEC and 2009/147/EC, in accordance with prioritised action frameworks established pursuant to Directive 92/43/EEC; (f) the management, restoration and monitoring of marine protected areas with a view to the implementation of the spatial protection measures referred to in Article 13(4) of Directive 2008/56/EC; (g) increasing environmental awareness, involving fishermen, with regard to the protection and restoration of marine biodiversity; (h) schemes for compensation for damage to catches caused by mammals and birds protected by Directives 92/43/EEC and 2009/147/EC; (i) the participation in other actions aimed at maintaining and enhancing biodiversity and ecosystem services, such as the restoration of specific marine and coastal habitats in support of sustainable fish stocks, including their scientific preparation and evaluation. 2. Support under point (h) of paragraph 1 shall be subject to the formal recognition of such schemes by the competent authorities of the Member States. Member States shall also ensure that no overcompensation for damage occurs as a result of the combination of Union, national and private compensation schemes. 3. The operations referred to in this Article may be implemented by scientific or technical public law bodies, Advisory Councils, fishermen or organisations of fishermen which are recognised by the Member State, or by non-governmental organisations in partnership with organisations of fishermen or in partnership with FLAGs. 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 126, specifying the costs which are eligible for support under paragraph 1 of this Article. Article 41 Energy efficiency and mitigation of climate change 1. In order to mitigate the effects of climate change and to improve the energy efficiency of fishing vessels, the EMFF may support: (a) investments in equipment or on board aimed at reducing the emission of pollutants or greenhouse gases and increasing the energy efficiency of fishing vessels. Investments in fishing gear are also eligible provided that they do not undermine the selectivity of that fishing gear; (b) energy efficiency audits and schemes; (c) studies to assess the contribution of alternative propulsion systems and hull designs to the energy efficiency of fishing vessels. 2. Support for the replacement or modernisation of main or ancillary engines may be granted only: (a) for vessels up to 12 metres in overall length, provided that the new or modernised engine does not have more power in kW than the current engine; (b) for vessels between 12 and 18 metres in overall length, provided that the power in kW of the new or modernised engine is at least 20 % lower than that of the current engine; (c) for vessels between 18 and 24 metres in overall length, provided that the power in kW of the new or modernised engine is at least 30 % lower than that of the current engine. 3. Support under paragraph 2 for the replacement or modernisation of main or ancillary engines may only be granted in respect of vessels belonging to a fleet segment for which the report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown a balance with the fishing opportunities available to that segment. 4. Support under paragraph 2 of this Article shall only be granted for the replacement or modernisation of main or ancillary engines which have been officially certified in accordance with Article 40(2) of Regulation (EC) No 1224/2009. It shall only be paid after any required reduction of capacity in kW has been permanently removed from the Union fishing fleet register. 5. For fishing vessels not subject to a certification of engine power, support under paragraph 2 of this Article shall only be granted for the replacement or modernisation of main or ancillary engines in respect of which the consistency of engine power has been verified in accordance with Article 41 of Regulation (EC) No 1224/2009 and which have been physically inspected to ensure that the engine power does not exceed the engine power established in the fishing licenses. 6. The reduction of engine power referred to in points(b) and (c) of paragraph 2 may be achieved by a group of vessels for each category of vessel referred to in those points. 7. Without prejudice to Article 25(3), support from the EMFF under paragraph 2 of this Article shall not exceed the higher of the following two thresholds: (a) EUR 1 500 000; or (b) 3 % of the Union financial support allocated by the Member State to the Union priorities set out in Article 6(1), (2) and (5). 8. Applications made by operators from the small\u2013scale coastal fishing sector shall be treated as a priority up to 60 % of the total support allocated for the replacement or modernisation of main or ancillary engines referred to in paragraph 2 over the entire programming period. 9. Support under paragraphs 1 and 2 shall only be granted to owners of fishing vessels and shall not be granted more than once for the same type of investment during the programming period for the same fishing vessel. 10. The Commission shall be empowered to adopt delegated acts, in accordance with Article 126, specifying the costs which are eligible for support under point (a) of paragraph 1 of this Article. Article 42 Added value, product quality and use of unwanted catches 1. In order to improve the added value or quality of the fish caught, the EMFF may support: (a) investments that add value to fishery products, in particular by allowing fishermen to carry out the processing, marketing and direct sale of their own catches; (b) innovative investments on board that improve the quality of the fishery products. 2. The support referred to in point (b) of paragraph 1 shall be conditional on the use of selective gears to minimise unwanted catches and shall only be granted to owners of Union fishing vessels that have carried out a fishing activity at sea for at least 60 days during the two calendar years preceding the date of submission of the application for support. Article 43 Fishing ports, landing sites, auction halls and shelters 1. For the purpose of increasing the quality, control and traceability of the products landed, increasing energy efficiency, contributing to environmental protection and improving safety and working conditions, the EMFF may support investments improving the infrastructure of fishing ports, auctions halls, landing sites and shelters, including investments in facilities for waste and marine litter collection. 2. In order to facilitate compliance with the obligation to land all catches in accordance with Article 15 of Regulation (EU) No 1380/2013 and Article 8(2)(b) of Regulation (EU) No 1379/2013, as well as to add value to under-used components of the catch, the EMFF may support investments in fishing ports, auction halls, landing sites and shelters. 3. In order to improve the safety of fishermen, the EMFF may support investments in the construction or modernisation of shelters. 4. Support shall not cover the construction of new ports, new landing sites or new auction halls. Article 44 Inland fishing and inland aquatic fauna and flora 1. In order to reduce the impact of inland fishing on the environment, to increase energy efficiency, to increase the value or quality of fish landed, or to improve health, safety, working conditions, human capital and training, the EMFF may support investments in the following: (a) the promotion of human capital, job creation and social dialogue as referred to in Article 29 and under the conditions set out in that Article; (b) on board or in individual equipment as referred to in Article 32 and under the conditions set out in that Article; (c) in equipment and types of operations as referred to in Articles 38 and 39 and under the conditions set out in those Articles; (d) the improvement of energy efficiency and the mitigation of the effects of climate change as referred to in Article 41 and under the conditions set out in that Article; (e) the improvement of the value or quality of the fish caught as referred to in Article 42 and under the conditions set out in that Article. (f) in fishing ports, shelters and landing sites as referred to in Article 43 and under the conditions set out in that Article; 2. The EMFF may provide support for investments relating to business start-ups for young fishermen as referred to in Article 31 and under the same conditions as set out in that Article, except for the requirement under point (b) of paragraph 2 of that Article. 3. The EMFF may provide support for the development and facilitation of innovation in accordance with Article 26, for the advisory services in accordance with Article 27 and for partnerships between scientists and fishermen in accordance with Article 28. 4. In order to promote diversification by inland fishermen, the EMFF may support the diversification of inland fishing activities to complementary activities under the conditions laid down in Article 30. 5. For the purposes of paragraph 1: (a) references made in Articles 30, 32, 38, 39, 41 and 42 to fishing vessels shall be understood as references to vessels operating exclusively in inland waters; (b) references made in Article 38 to the marine environment shall be understood as references to the environment in which the inland fishing vessel operates. 6. In order to protect and develop aquatic fauna and flora, the EMFF may support: (a) the management, restoration and monitoring of NATURA 2000 sites which are affected by fishing activities, and the rehabilitation of inland waters in accordance with Directive 2000/60/EC of the European Parliament and of the Council (30), including spawning grounds and migration routes for migratory species, without prejudice to point (e) of Article 40(1) of this Regulation and, where relevant, with the participation of inland fishermen; (b) the construction, modernisation or installation of static or movable facilities intended to protect and enhance aquatic fauna and flora, including their scientific preparation, monitoring and evaluation. 7. Member States shall ensure that vessels receiving support under this Article continue to operate exclusively in inland waters. CHAPTER II Sustainable development of aquaculture Article 45 Specific objectives Support under this Chapter shall contribute to the achievement of the specific objectives under the Union priority set out in Article 6(2). Article 46 General conditions 1. Support under this Chapter shall be limited to aquaculture enterprises, unless otherwise stated in this Regulation. 2. For the purposes of this Article, entrepreneurs entering the sector shall provide a business plan and, where the amount of investments is more than EUR 50 000, a feasibility study including an environmental assessment of the operations. Support under this Chapter shall be granted only where it has been clearly demonstrated in an independent marketing report that good and sustainable market prospects exist for the product. 3. Where operations consist of investments in equipment or infrastructure ensuring compliance with future requirements relating to the environment, human or animal health, hygiene or animal welfare under Union law, support may be granted until the date on which such requirements become mandatory for the enterprises. 4. Support shall not be granted to the farming of genetically modified organisms. 5. Support shall not be granted to aquaculture operations in marine protected areas, if it has been determined by the competent authority of the Member State, on the basis of an environmental impact assessment, that the operation would generate significant negative environmental impact that cannot be adequately mitigated. Article 47 Innovation 1. In order to stimulate innovation in aquaculture, the EMFF may support operations aiming at: (a) developing technical, scientific or organisational knowledge in aquaculture farms, which, in particular, reduces the impact on the environment, reduces dependence on fish meal and oil, fosters a sustainable use of resources in aquaculture, improves animal welfare or facilitates new sustainable production methods; (b) developing or introducing on the market new aquaculture species with good market potential, new or substantially improved products, new or improved processes, or new or improved management and organisation systems; (c) exploring the technical or economic feasibility of innovative products or processes. 2. Operations under this Article shall be carried out by, or in collaboration with, public or private scientific or technical bodies, recognised by the Member State, which shall validate the results of such operations. 3. The results of operations receiving support shall be adequately publicised by the Member State in accordance with Article 119. Article 48 Productive investments in aquaculture 1. The EMFF may support: (a) productive investments in aquaculture; (b) the diversification of aquaculture production and species cultured; (c) the modernisation of aquaculture units, including the improvement in working and safety conditions of aquaculture workers; (d) improvements and modernisation related to animal health and welfare, including the purchase of equipment aiming at protecting the farms from wild predators; (e) investments reducing the negative impact or enhancing the positive effects on the environment and increasing resource efficiency; (f) investments in enhancing the quality of, or in adding value to, aquaculture products; (g) the restoration of existing aquaculture ponds or lagoons through the removal of silt, or investments aimed at the prevention of silt deposits; (h) the diversification of the income of aquaculture enterprises through the development of complementary activities; (i) investments resulting in a substantial reduction in the impact of aquaculture enterprises on water usage and quality, in particular through reducing the amount of water or chemicals, antibiotics and other medicines used, or through improving the output water quality, including through the deployment of multi\u2013trophic aquaculture systems; (j) the promotion of closed aquaculture systems where aquaculture products are farmed in closed recirculation systems, thereby minimising water use; (k) investments increasing energy efficiency and promoting the conversion of aquaculture enterprises to renewable sources of energy. 2. Support under point (h) of paragraph 1 shall only be granted to aquaculture enterprises if the complementary activities relate to the core aquaculture business of the enterprise, including angling tourism, environmental services related to aquaculture or educational activities concerning aquaculture. 3. Support under paragraph 1 may be granted for the increase in production and/or modernisation of existing aquaculture enterprises, or for the construction of new ones, provided that the development is consistent with the multiannual national strategic plan for the development of aquaculture referred to in Article 34 of Regulation (EU) No 1380/2013. Article 49 Management, relief and advisory services for aquaculture farms 1. In order to improve the overall performance and competitiveness of aquaculture farms, and to reduce the negative environmental impact of their operations, the EMFF may support: (a) the setting-up of management, relief and advisory services for aquaculture farms; (b) the purchase of farm advisory services of a technical, scientific, legal, environmental or economic nature. 2. Advisory services referred to in point (b) of paragraph 1 shall cover: (a) the management needs to enable aquaculture farms to comply with Union and national environmental legislation, as well as with maritime spatial planning requirements; (b) environmental impact assessment as referred to in Directive 2001/42/EC of the European Parliament and of the Council (31) and Directive 92/43/EEC; (c) the management needs to enable aquaculture farms to comply with Union and national aquatic animal health and welfare or public health legislation; (d) health and safety standards based on Union and national legislation; (e) marketing and business strategies. 3. The advisory services referred to in point (b) of paragraph 1 shall be provided by scientific or technical bodies, as well as by entities providing legal or economic advice with the required competences as recognised by the Member State. 4. Support under point (a) of paragraph 1 shall only be granted to public law bodies or other entities selected by the Member State to set up the farm advisory services. Support under point (b) of paragraph 1 shall only be granted to aquaculture SMEs or aquaculture organisations, including aquaculture producer organisations and associations of aquaculture producer organisations. 5. Where the support does not exceed EUR 4 000, the beneficiary may be selected by means of an accelerated procedure. 6. Beneficiaries shall not receive support more than once per year for each category of advisory services referred to in paragraph 2. Article 50 Promotion of human capital and networking 1. In order to promote human capital and networking in aquaculture, the EMFF may support: (a) professional training, lifelong learning, the dissemination of scientific and technical knowledge and innovative practices, the acquisition of new professional skills in aquaculture and with regard to the reduction of the environmental impact of aquaculture operations; (b) the improvement of working conditions and the promotion of occupational safety; (c) networking and exchange of experiences and best practices among aquaculture enterprises or professional organisations and other stakeholders, including scientific and technical bodies or those promoting equal opportunities between men and women. 2. Support referred to in point (a) of paragraph 1 shall not be granted to large aquaculture enterprises, unless they are engaged in knowledge-sharing with SMEs. 3. By way of derogation from Article 46, support under this Article shall also be granted to public or semi-public organisations and to other organisations recognised by the Member State. 4. Support under this Article shall also be granted to spouses of self-employed aquaculture farmers or, where and in so far as they are recognised by national law, to the life partners of self-employed aquaculture farmers, under the conditions laid down in point (b) of Article 2 of Directive 2010/41/EU. Article 51 Increasing the potential of aquaculture sites 1. In order to contribute to the development of the aquaculture sites and infrastructures, and to reduce the negative environmental impact of the operations, the EMFF may support: (a) the identification and mapping of the most suitable areas for developing aquaculture, taking into account, where applicable, spatial planning processes, and the identification and mapping of areas where aquaculture should be excluded in order to maintain the role of such areas in the functioning of the ecosystem; (b) the improvement and development of support facilities and infrastructures required to increase the potential of aquaculture sites and to reduce the negative environmental impact of aquaculture, including investments in land consolidation, energy supply or water management; (c) action taken and implemented by competent authorities under Article 9(1) of Directive 2009/147/EC or Article 16(1) of Directive 92/43/EEC, with the aim of preventing serious damage to aquaculture; (d) action taken and implemented by competent authorities following the detection of increased mortalities or diseases as provided for in Article 10 of Council Directive 2006/88/EC (32). Those actions may cover the adoption of shellfish action plans aimed at the protection, restoration and management, including support to shellfish producers for the maintenance, of natural shellfish banks and catchment areas. 2. Beneficiaries of support under this Article shall only be public law bodies or private bodies entrusted by the Member State with the tasks referred to in paragraph 1. Article 52 Encouraging new aquaculture farmers practising sustainable aquaculture 1. In order to foster entrepreneurship in aquaculture, the EMFF may support the setting-up of sustainable aquaculture enterprises by new aquaculture farmers. 2. Support under paragraph 1 shall be granted to aquaculture farmers entering the sector provided that they: (a) possess adequate professional skills and competence; (b) set up for the first time an aquaculture micro or small enterprise, as managers of that enterprise; and (c) submit a business plan for the development of their aquaculture activities. 3. In order to acquire adequate professional skills, aquaculture farmers entering the sector may benefit from support under point (a) of Article 50(1). Article 53 Conversion to eco-management and audit schemes and organic aquaculture 1. In order to promote the development of organic or energy\u2013efficient aquaculture, the EMFF may support: (a) the conversion of conventional aquaculture production methods into organic aquaculture within the meaning of Council Regulation (EC) No 834/2007 (33) and in accordance with Commission Regulation (EC) No 710/2009 (34); (b) the participation in the Union eco-management and audit schemes (EMAS) established by Regulation (EC) No 761/2001 of the European Parliament and of the Council (35). 2. Support shall only be granted to beneficiaries who commit themselves to participate in the EMAS for a minimum of three years or to comply with the requirements of organic production for a minimum of five years. 3. Support shall take the form of compensation for a maximum of three years during the period of the conversion of the enterprise to organic production, or during the preparation for participation in the EMAS. Member States shall calculate that compensation on the basis of: (a) the loss of revenue or additional costs incurred during the period of transition from conventional into organic production for operations eligible under point (a) of paragraph 1; or (b) the additional costs resulting from the application and preparation of the participation in EMAS for operations eligible under point (b) of paragraph 1. Article 54 Aquaculture providing environmental services 1. In order to foster the development of aquaculture providing environmental services, the EMFF may support: (a) aquaculture methods compatible with specific environmental needs and subject to specific management requirements resulting from the designation of NATURA 2000 areas in accordance with Directives 92/43/EEC and 2009/147/EC; (b) participation, in terms of costs directly related thereto, in ex-situ conservation and reproduction of aquatic animals, within the framework of conservation and biodiversity restoration programmes developed by public authorities, or under their supervision; (c) aquaculture operations which include conservation and improvement of the environment and of biodiversity, and management of the landscape and traditional features of aquaculture zones. 2. Support under point (a) of paragraph 1 shall take the form of annual compensation for the additional costs incurred and/or income foregone as a result of management requirements in the areas concerned, related to the implementation of Directives 92/43/EEC or 2009/147/EC. 3. Support under point (c) of paragraph 1 shall be granted only to beneficiaries who commit themselves for a minimum period of five years to aqua-environmental requirements that go beyond the mere application of Union and national law. The environmental benefits of the operation shall be demonstrated by a prior assessment conducted by competent bodies designated by the Member State, unless the environmental benefits of that operation are already recognised. 4. Support under point (c) of paragraph 1 shall take the form of annual compensation for the additional costs incurred and/or income foregone. 5. The results of operations receiving support under this Article shall be adequately publicised by the Member State in accordance with Article 119. Article 55 Public health measures 1. The EMFF may support compensation to mollusc farmers for the temporary suspension of harvesting of farmed molluscs, where such suspension occurs exclusively for reasons of public health. 2. Support may only be granted where the suspension of harvesting due to the contamination of molluscs is the result of the proliferation of toxin-producing plankton or the presence of plankton containing biotoxins, and provided that: (a) the contamination lasts for more than four consecutive months; or (b) the loss, resulting from the suspension of the harvest, amounts to more than 25 % of the annual turnover of the business concerned, calculated on the basis of the average turnover of that business over the three calendar years preceding the year in which the harvest was suspended. For the purposes of point (b) of the first subparagraph, Member States may establish special calculation rules in respect of companies with less than three years of activity. 3. The duration for which compensation may be granted shall be a maximum of 12 months over the entire programming period. In duly justified cases, it may be extended once for a maximum of an additional 12 months up to a combined maximum of 24 months. Article 56 Animal health and welfare measures 1. In order to foster animal health and welfare in aquaculture enterprises, inter alia, in terms of prevention and bio-security, the EMFF may support: (a) the costs of control and eradication of diseases in aquaculture in accordance with Council Decision 2009/470/EC (36), including the operational costs necessary to fulfil the obligations in an eradication plan; (b) the development of general and species-specific best practices or codes of conduct on bio-security or on animal health and animal welfare needs in aquaculture; (c) initiatives aimed at reducing the dependence of aquaculture on veterinary medicine; (d) veterinary or pharmaceutical studies and dissemination and exchange of information and best practices regarding veterinary diseases in aquaculture, with the aim of promoting an appropriate use of veterinary medicine; (e) the establishment and operation of health protection groups in the aquaculture sector as recognised by Member States; (f) compensation to mollusc farmers for the temporary suspension of their activities due to exceptional mass mortality, if the mortality rate exceeds 20 %, or if the loss resulting from the suspension of the activity amounts to more than 35 % of the annual turnover of the business concerned, calculated on the basis of the average turnover of that business over the three calendar years preceding the year in which the activities were suspended. 2. Support under point (d) of paragraph 1 shall not cover the purchase of veterinary medicines. 3. The results of the studies financed under point (d) of paragraph 1 shall be adequately reported and publicised by the Member State in accordance with Article 119. 4. Support may also be granted to public law bodies. Article 57 Aquaculture stock insurance 1. In order to safeguard the income of aquaculture producers, the EMFF may contribute to an aquaculture stock insurance covering economic losses due to at least one of the following: (a) natural disasters; (b) adverse climatic events; (c) sudden water quality and quantity changes for which the operator is not responsible; (d) diseases in aquaculture, failure or destruction of production facilities for which the operator is not responsible. 2. The occurrence of the circumstances referred to in paragraph 1 in aquaculture shall be formally recognised as such by the Member State concerned. 3. Member States may, where appropriate, establish in advance criteria on the basis of which the formal recognition referred to in paragraph 2 shall be deemed to be granted. 4. Support shall only be granted for aquaculture stock insurance contracts which cover economic losses, as referred to in paragraph 1, exceeding 30 % of the average annual turnover of the aquaculture farmer, calculated on the basis of the average turnover of the aquaculture farmer over the three calendar years preceding the year in which the economic losses occurred. CHAPTER III Sustainable development of fisheries and aquaculture areas Section 1 Scope and objectives Article 58 Scope The EMFF shall support the sustainable development of fisheries and aquaculture areas following a community\u2013led local development approach as set out in Article 32 of Regulation (EU) No 1303/2013. Article 59 Specific objectives Support under this Chapter shall contribute to the achievement of the specific objectives under the Union priority set out in Article 6(4). Section 2 Community\u2013led local development strategies and fisheries local action groups Article 60 Community\u2013led local development strategies 1. In order to contribute to the achievement of the objectives referred to in Article 59, community\u2013led local development strategies shall: (a) maximise the participation of fishery and aquaculture sectors in the sustainable development of coastal and inland fisheries and aquaculture areas; (b) ensure that local communities fully exploit and benefit from the opportunities offered by maritime, coastal and inland water development and, in particular, help small and declining fishing ports to maximise their marine potential by developing a diversified infrastructure. 2. The strategies shall be coherent with the opportunities and needs identified in the relevant area and the Union priorities set out in Article 6. Strategies may range from those which focus on fisheries to broader strategies directed at the diversification of fisheries areas. The strategies shall go beyond a mere collection of operations or juxtaposition of sectoral measures. Article 61 Fisheries local action groups 1. For the purposes of the EMFF, the local action groups referred to in Article 32(2)(b) of Regulation (EU) No 1303/2013 shall be designated as Fisheries local action groups (FLAGs). 2. The FLAGs shall propose a community\u2013led local development strategy based on, at least, the elements set out in Article 60 of this Regulation and shall be responsible for its implementation. 3. The FLAGs shall: (a) broadly reflect the main focus of their strategy and the socioeconomic composition of the area through a balanced representation of the main stakeholders, including private sector, public sector and civil society; (b) ensure a significant representation of the fisheries and/or aquaculture sectors. 4. If the community\u2013led local development strategy is supported by other Funds in addition to the EMFF, the selection body of the FLAGs for the EMFF supported projects shall also fulfil the requirements set out in paragraph 3. 5. FLAGs may also carry out additional tasks going beyond the minimum tasks provided for in Article 34(3) of Regulation (EU) No 1303/2013, where such tasks are delegated to them by the managing authority. Section 3 Eligible operations Article 62 Support from the EMFF for community\u2013led local development 1. The following operations are eligible for support under this Section in accordance with Article 35 of Regulation (EU) No 1303/2013: (a) preparatory support; (b) implementation of community\u2013led local development strategies; (c) cooperation activities; (d) running costs and animation. 2. FLAGs may request the payment of an advance from the managing authority if such possibility is provided for in the operational programme. The amount of the advances shall not exceed 50 % of the public support related to the running costs and animation. Article 63 Implementation of community\u2013led local development strategies 1. Support for the implementation of community\u2013led local development strategies may be granted for the following objectives: (a) adding value, creating jobs, attracting young people and promoting innovation at all stages of the supply chain of fishery and aquaculture products; (b) supporting diversification inside or outside commercial fisheries, lifelong learning and job creation in fisheries and aquaculture areas; (c) enhancing and capitalising on the environmental assets of the fisheries and aquaculture areas, including operations to mitigate climate change; (d) promoting social well-being and cultural heritage in fisheries and aquaculture areas, including fisheries, aquaculture and maritime cultural heritage; (e) strengthening the role of fisheries communities in local development and the governance of local fisheries resources and maritime activities. 2. The support referred to in paragraph 1 may include measures provided for in Chapters I, II and IV of this Title, with the exception of Articles 66 and 67, provided that there is a clear rationale for their management at local level. Where support is granted for operations corresponding to those measures, the relevant conditions and the scales of contribution per operation laid down in Chapters I, II and IV of this Title shall apply. Article 64 Cooperation activities 1. Support referred to in Article 35(1)(c) of Regulation (EU) No 1303/2013 may be granted to: (a) inter-territorial or transnational cooperation projects; (b) preparatory technical support for inter-territorial and transnational cooperation projects, on the condition that FLAGs can demonstrate that they are preparing the implementation of a project. For the purposes of this Article, the term \u2018inter-territorial cooperation\u2019 means cooperation within a Member State, and the term \u2018transnational cooperation\u2019 means cooperation between territories in several Member States or cooperation between at least one territory of a Member State and one or more territories in third countries. 2. For the purposes of this Article, apart from other FLAGs, the partners of a FLAG under the EMFF may be a local public\u2013private partnership that is implementing a community\u2013led local development strategy within or outside the Union. 3. In cases where co\u2013operation projects are not selected by the FLAGs, Member States shall establish an appropriate system for the purpose of facilitating cooperation projects. They shall make public the national or regional administrative procedures concerning the selection of transnational cooperation projects and a list of eligible costs at the latest two years after the date of approval of their operational programme. 4. Administrative decisions concerning cooperation projects shall take place no later than four months after the date of submission of the project. 5. Member States shall communicate to the Commission the approved transnational cooperation projects in accordance with Article 110. CHAPTER IV Marketing and processing related measures Article 65 Specific objectives Support under this Chapter shall contribute to the achievement of the specific objectives under the Union priority set out in Article 6(5). Article 66 Production and marketing plans 1. The EMFF shall support the preparation and implementation of production and marketing plans referred to in Article 28 of Regulation (EU) No 1379/2013. 2. Expenditure related to production and marketing plans shall be eligible for support from the EMFF only after approval by the competent authorities in the Member State of the annual report referred to in Article 28(5) of Regulation (EU) No 1379/2013. 3. Support granted per producer organisation per year under this Article shall not exceed 3 % of the average annual value of the production placed on the market by that producer organisation during the preceding three calendar years. For any newly recognised producer organisation, that support shall not exceed 3 % of the average annual value of the production placed on the market by the members of that organisation during the preceding three calendar years. 4. The Member State concerned may grant an advance of 50 % of the financial support after approval of the production and marketing plan in accordance with Article 28(3) of Regulation (EU) No 1379/2013. 5. The support referred to in paragraph 1 shall only be granted to producer organisations and associations of producers organisations. Article 67 Storage aid 1. The EMFF may support compensation to recognised producer organisations and associations of producers organisations which store fishery products listed in Annex II to Regulation (EU) No 1379/2013, provided that those products are stored in accordance with Articles 30 and 31 of that Regulation and subject to the following conditions: (a) the amount of the storage aid does not exceed the amount of the technical and financial costs of the actions required for the stabilisation and storage of the products in question; (b) the quantities eligible for storage aid do not exceed 15 % of the annual quantities of the products concerned put up for sale by the producer organisation; (c) the financial support per year does not exceed 2 % of the average annual value of the production placed on the market by the members of the producer organisation in the period 2009-2011. For the purposes of point (c) of the first subparagraph, where a member of the producer organisation did not have any production placed on the market in the period 2009 to 2011, the average annual value of production placed on the market in the first three years of production of that member shall be taken into account. 2. The support referred to in paragraph 1 shall end by 31 December 2018. 3. The support referred to in paragraph 1 shall only be granted once the products are released for human consumption. 4. Member States shall fix the amount of the technical and financial costs applicable in their territories as follows: (a) technical costs shall be calculated each year on the basis of direct costs relating to the actions required in order to stabilise and store the products in question; (b) financial costs shall be calculated each year using the interest rate set annually in each Member State; These technical and financial costs shall be made publicly available. 5. Member States shall carry out controls to ensure that the products benefiting from storage aid fulfil the conditions laid down in this Article. For the purposes of such controls, beneficiaries of storage aid shall keep stock records for each category of products entered into storage and later reintroduced onto the market for human consumption. Article 68 Marketing measures 1. The EMFF may support marketing measures for fishery and aquaculture products which are aimed at: (a) creating producer organisations, associations of producer organisations or inter-branch organisations to be recognised in accordance with Section II of Chapter II of Regulation (EU) No 1379/2013; (b) finding new markets and improving the conditions for the placing on the market of fishery and aquaculture products, including: (i) species with marketing potential; (ii) unwanted catches landed from commercial stocks in accordance with technical measures, Article 15 of Regulation (EU) No 1380/2013 and Article 8(2)(b) of Regulation (EU) No 1379/2013; (iii) fishery and aquaculture products obtained using methods with low impact on the environment, or organic aquaculture products within the meaning of Regulation (EC) No 834/2007; (c) promoting the quality and the value added by facilitating: (i) the application for registration of a given product and the adaptation of concerned operators to the relevant compliance and certification requirements in accordance with Regulation (EU) No 1151/2012 of the European Parliament and of the Council (37); (ii) the certification and the promotion of sustainable fishery and aquaculture products, including products from small\u2013scale coastal fishing, and of environmentally-friendly processing methods; (iii) the direct marketing of fishery products by small\u2013scale coastal fishermen or by on\u2013foot fishermen; (iv) the presentation and packaging of products; (d) contributing to the transparency of production and the markets and conducting market surveys and studies on the Union\u2019s dependence on imports; (e) contributing to the traceability of fishery or aquaculture products and, where relevant, the development of a Union\u2013wide ecolabel for fishery and aquaculture products as referred to in Regulation (EU) No 1379/2013; (f) drawing up standard contracts for SMEs, which are compatible with Union law; (g) conducting regional, national or transnational communication and promotional campaigns, to raise public awareness of sustainable fishery and aquaculture products. 2. The operations referred to in paragraph 1 may include the production, processing and marketing activities along the supply chain. The operations referred to in point (g) of paragraph 1 shall not be aimed at commercial brands. Article 69 Processing of fishery and aquaculture products 1. The EMFF may support investments in the processing of fishery and aquaculture products that: (a) contribute to energy saving or reducing the impact on the environment, including waste treatment; (b) improve safety, hygiene, health and working conditions; (c) support the processing of catches of commercial fish that cannot be destined for human consumption; (d) relate to the processing of by-products resulting from main processing activities; (e) relate to the processing of organic aquaculture products pursuant to Articles 6 and 7 of Regulation (EC) No 834/2007; (f) lead to new or improved products, new or improved processes, or new or improved management and organisation systems. 2. As regards enterprises other than SMEs, the support referred to in paragraph 1 shall only be granted through the financial instruments provided for in Title IV of Part Two of Regulation (EU) No 1303/2013. CHAPTER V Compensation for additional costs in outermost regions for fishery and aquaculture products Article 70 Compensation regime 1. The EMFF may support the compensation of additional costs incurred by operators in the fishing, farming, processing and marketing of certain fishery and aquaculture products from the outermost regions referred to in Article 349 TFEU. 2. Each Member State concerned shall determine, for the regions referred to in paragraph 1, the list of fishery and aquaculture products and the quantity of those products eligible for compensation. 3. When establishing the list and the quantities referred to in paragraph 2, Member States shall take into account all relevant factors, in particular the need to ensure that the compensation is fully compatible with the CFP rules. 4. The compensation shall not be granted for fishery and aquaculture products: (a) caught by third country vessels, with the exception of fishing vessels which fly the flag of Venezuela and operate in Union waters; (b) caught by Union fishing vessels that are not registered in a port of one of the regions referred to in paragraph 1; (c) imported from third countries. 5. Point (b) of paragraph 4 shall not apply if the existing capacity of the processing industry in the outermost region concerned exceeds the quantity of raw material supplied in accordance with the compensation plan of the region concerned. 6. The following operators shall be eligible for compensation: (a) natural or legal persons using means of production to obtain fishery or aquaculture products with a view to placing them on the market; (b) the owners or operators of vessels that are registered in the ports of the regions referred to in paragraph 1 and that are operating in those regions, or associations of such owners or operators; (c) the operators in the processing and marketing sector or associations of such operators. Article 71 Calculation of the compensation The compensation shall be paid to the operators referred to in Article 70(6) carrying out activities in the regions referred to in Article 70(1) and shall take into account: (a) for each fishery or aquaculture product or category of products, the additional costs resulting from the specific handicaps of the regions concerned; and (b) any other type of public intervention affecting the level of additional costs. Article 72 Compensation plan 1. The Member States concerned shall submit to the Commission a compensation plan for each region referred to in Article 70(1). That plan shall include the list, and quantities of fishery and aquaculture products and the type of operators referred to in Article 70, the level of compensation referred to in Article 71 and the managing authority referred to in Article 97. The Commission shall adopt implementing acts setting out its decision whether to approve such compensation plans. 2. Member States may amend the content of the compensation plan referred to in paragraph 1. Member States shall submit such amendments to the Commission. The Commission shall adopt implementing acts setting out its decision whether to approve those amendments. 3. The Commission shall adopt implementing acts defining the structure of the compensation plan. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3). 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 126, laying down the criteria for the calculation of the additional costs resulting from the specific handicaps of the regions concerned. Article 73 State aid for implementing compensation plans Member States may grant additional financing for the implementation of the compensation plans referred to in Article 72. In such cases, Member States shall notify the Commission of the State aid which the Commission may approve in accordance with this Regulation as part of those plans. State aid thus notified shall be regarded as notified within the meaning of the first sentence of Article 108(3) TFEU. CHAPTER VI Accompanying measures for the CFP under shared management Article 74 Geographical scope By way of derogation from Article 2, this Chapter shall also apply to operations carried out outside the territory of the Union. Article 75 Specific objectives Support under this Chapter shall contribute to achieving the specific objectives under the Union priority set out in Article 6(3). Article 76 Control and enforcement 1. The EMFF may support the implementation of a Union control, inspection and enforcement system as provided for in Article 36 of Regulation (EU) No 1380/2013 and further specified in Regulation (EC) No 1224/2009. 2. In particular, the following types of operations shall be eligible: (a) the purchase, installation and development of technology, including computer hardware and software, vessel detection systems (VDS), closed-circuit television (CCTV) systems and IT networks enabling the gathering, administration, validation, analysis, risk management, presentation (by means of the websites related to control) and exchange of, and the development of sampling methods for, data related to fisheries, as well as interconnection to cross-sectoral data exchange systems; (b) the development, purchase and installation of the components, including computer hardware and software, that are necessary to ensure data transmission from actors involved in fishing and the marketing of fishery products to the relevant Member State and Union authorities, including the necessary components for electronic recording and reporting systems (ERS), vessel monitoring systems (VMS) and automatic identification systems (AIS) used for control purposes; (c) the development, purchase and installation of the components, including computer hardware and software, which are necessary to ensure the traceability of fishery and aquaculture products, as referred to in Article 58 of Regulation (EC) No 1224/2009; (d) the implementation of programmes for exchanging data between Member States and for analysing them; (e) the modernisation and purchase of patrol vessels, aircrafts and helicopters, provided that they are used for fisheries control for at least 60 % of the total period of use per year; (f) the purchase of other control means, including devices to enable the measurement of engine power and weighing equipment; (g) the development of innovative control and monitoring systems and the implementation of pilot projects related to fisheries control, including fish DNA analysis or the development of websites related to control; (h) training and exchange programmes, including between Member States, of personnel responsible for the monitoring, control and surveillance of fisheries activities; (i) cost/benefit analyses and assessments of audits performed and expenditure incurred by competent authorities in carrying out monitoring, control and surveillance; (j) initiatives, including seminars and media tools, aimed at enhancing awareness, among both fishermen and other players such as inspectors, public prosecutors and judges, as well as among the general public, of the need to fight illegal, unreported and unregulated fishing and of the implementation of the CFP rules; (k) operational costs incurred in carrying out more stringent control for stocks subject to specific control and inspection programmes established in accordance with Article 95 of Regulation (EC) No 1224/2009 and subject to control coordination in accordance with Article 15 of Council Regulation (EC) No 768/2005 (38); (l) programmes linked to the implementation of an action plan established in accordance with Article 102(4) of Regulation (EC) No 1224/2009, including any operational costs incurred. 3. The measures listed in points (h) to (l) of paragraph 2 shall only be eligible for support if they relate to control activities carried out by a public authority. 4. In the case of the measures listed in points (d) and (h) of paragraph 2, the Member States concerned shall designate the managing authorities responsible for the project. Article 77 Data collection 1. The EMFF shall support the collection, management and use of data, as provided for in Article 25(1) and (2) of Regulation (EU) No 1380/2013 and further specified in Regulation (EC) No 199/2008. 2. In particular, the following types of operations shall be eligible: (a) the collection, management and use of data for the purpose of scientific analysis and implementation of the CFP; (b) national, transnational and subnational multiannual sampling programmes, provided that they relate to stocks covered by the CFP; (c) at-sea monitoring of commercial and recreational fisheries, including monitoring of by-catch of marine organisms such as marine mammals and birds; (d) research surveys at sea; (e) the participation of representatives of Member States and regional authorities in regional coordination meetings, meetings of regional fisheries management organisations of which the Union is a contracting party or an observer, or meetings of international bodies responsible for providing scientific advice; (f) the improvement of data collection and data management systems and the implementation of pilot studies to improve existing data collection and data management systems. CHAPTER VII Technical assistance at the initiative of Member States Article 78 Technical assistance at the initiative of Member States 1. The EMFF may support, at the initiative of a Member State, and subject to a ceiling of 6 % of the total amount of the operational programme: (a) the measures of technical assistance referred to in Article 59(1) of Regulation (EU) No 1303/2013; (b) the establishment of national networks aiming at disseminating information, capacity building, exchanging best practices and supporting cooperation between the FLAGs in the territory of the Member State. 2. In duly justified circumstances, the threshold referred to in paragraph 1 may exceptionally be exceeded. CHAPTER VIII The IMP measures financed under shared management Article 79 Specific objectives 1. Support under this Chapter shall contribute to the achievement of the specific objectives under the Union priority set out in Article 6(6), including: (a) the Integrated maritime surveillance (IMS) and, in particular, the Common information sharing environment (CISE) for the surveillance of the Union maritime domain; (b) the promotion of the protection of the marine environment, in particular its biodiversity and marine protected areas such as Natura 2000 sites, without prejudice to Article 37 of this Regulation, and the sustainable use of marine and coastal resources, and the further definition of the boundaries of the sustainability of human activities that have an impact on the marine environment, in particular in the framework of Directive 2008/56/EC. 2. Amendments of the operational programme with regard to the measures referred to in paragraph 1 shall not result in an increase of the total financial allocation referred to in Article 13(7). Article 80 Eligible operations 1. The EMFF may support operations in accordance with the objectives set out in Article 79, such as operations that: (a) contribute to achieving the objectives of the IMS and, in particular, those of the CISE; (b) protect the marine environment, in particular its biodiversity and marine protected areas such as Natura 2000 sites, in accordance with the obligations established in Directives 92/43/EEC and 2009/147/EC; (c) improve the knowledge on the state of the marine environment, with a view to establishing the monitoring programmes and the programmes of measures provided for in Directive 2008/56/EC, in accordance with the obligations established in that Directive. 2. The salary costs of personnel of national administrations shall not be considered to be eligible operating costs. TITLE VI MEASURES FINANCED UNDER DIRECT MANAGEMENT CHAPTER I Integrated maritime policy Article 81 Geographical scope By way of derogation from Article 2, this Chapter shall also apply to operations carried out outside the territory of the Union. Article 82 Scope and objectives Support under this Chapter shall contribute to enhancing the development and implementation of the Union\u2019s IMP. It shall: (a) foster the development and implementation of integrated governance of maritime and coastal affairs, in particular by: (i) promoting actions which encourage Member States and their regions to develop, introduce or implement integrated maritime governance; (ii) promoting dialogue and cooperation with and among competent authorities of the Member States and stakeholders on marine and maritime issues, including by developing and implementing integrated sea-basin strategies taking into account a balanced approach in all sea basins as well as the specific characteristics of the sea basins and sub-sea basins, and relevant macro-regional strategies where applicable; (iii) promoting cross-sectoral cooperation platforms and networks, including representatives of public authorities at national, regional and local level, industry including tourism, research stakeholders, citizens, civil society organisations and the social partners; (iv) improving the cooperation between Member States through exchange of information and best practices among their competent authorities; (v) promoting the exchange of best practices and dialogue at international level, including bilateral dialogue with third countries, taking into account UNCLOS and the relevant international conventions based on UNCLOS, without prejudice to other agreements or arrangements which may exist between the Union and the third countries concerned. Such dialogue shall include, as appropriate, effective discussion on the ratification and implementation of UNCLOS; (vi) enhancing the visibility of, and raising the awareness of public authorities, the private sector and the general public to an integrated approach to, maritime affairs; (b) contribute to the development of cross-sectoral initiatives that are mutually beneficial to different maritime sectors and/or sectoral policies, taking into account and building upon existing tools and initiatives, such as: (i) the IMS so as to reinforce the safe, secure and sustainable use of maritime space in particular by enhancing effectiveness and efficiency through information exchange across sectors and borders, while taking due account of existing and future cooperation mechanisms and systems; (ii) maritime spatial planning and integrated coastal zone management processes; (iii) the progressive development of a comprehensive and publicly accessible high quality marine data and knowledge base which shall facilitate the sharing, re-use and dissemination of those data and knowledge among various user groups, thus avoiding a duplication of efforts; for that purpose, the best use shall be made of existing Union and Member States\u2019 programmes; (c) support sustainable economic growth, employment, innovation and new technologies within emerging and prospective maritime sectors, as well as in coastal, insular and outermost regions of the Union, in a way that complements established sectoral and national activities; (d) promote the protection of the marine environment, in particular its biodiversity and marine protected areas such as Natura 2000 sites, and the sustainable use of marine and coastal resources and to further define the boundaries of the sustainability of human activities that have an impact on the marine environment, in accordance with the objectives of achieving and maintaining a good environmental status as required by Directive 2008/56/EC. Article 83 Eligible operations 1. The EMFF may support operations in accordance with the objectives set out in Article 82, such as: (a) studies; (b) projects, including test projects and cooperation projects; (c) public information and sharing best practices, awareness-raising campaigns and associated communication and dissemination activities such as publicity campaigns, events, the development and maintenance of websites, and stakeholder platforms; (d) conferences, seminars, fora and workshops; (e) coordination activities, including information-sharing networks, and development support for sea\u2013basin strategies; (f) the development, operation and maintenance of IT systems and networks enabling the gathering, administration, validation, analysis and exchange of, and the development of sampling methods for, data, as well as interconnection to cross\u2013sectoral data exchange systems; (g) training projects for the development of knowledge, professional qualifications and measures aimed at promoting professional development in the maritime sector. 2. In order to achieve the specific objective of developing cross\u2013border and cross\u2013sectoral operations set out in point (b) of Article 82, the EMFF may support: (a) the development and implementation of technical tools for the IMS, in particular for supporting the deployment, operation and maintenance of the CISE, with a view to promoting cross-sectoral and cross-border surveillance information exchanges interlinking all user communities, taking into account the relevant developments of sectoral policies as regards surveillance and contributing, as appropriate, to their necessary evolution; (b) activities of coordination and cooperation between Member States or regions in order to develop maritime spatial planning and integrated coastal zone management, including expenditure related to systems and practices of data sharing and monitoring, evaluation activities, the setting-up and running of networks of experts, and the setting-up of a programme aimed at building capacity for Member States to implement maritime spatial planning; (c) initiatives to co-finance, purchase and maintain marine observation systems and technical tools for designing, setting-up and running an operational European marine observation and data network system which aims to facilitate the collection, acquisition, assembly, processing, quality control, re-use and distribution of marine data and knowledge, through cooperation between Member States and/or international institutions concerned. CHAPTER II Accompanying measures for the CFP and the IMP under direct management Article 84 Geographical scope By way of derogation from Article 2, this Chapter shall also apply to operations carried out outside the territory of the Union. Article 85 Specific objectives Measures under this Chapter shall facilitate the implementation of the CFP and the IMP, in particular with regard to: (a) the collection, management and dissemination of scientific advice under the CFP; (b) specific control and enforcement measures under the CFP; (c) voluntary contributions to international organisations; (d) Advisory Councils; (e) market intelligence; (f) communication activities under the CFP and the IMP. Article 86 Scientific advice and knowledge 1. The EMFF may support the provision of scientific deliverables, particularly applied\u2013research projects directly linked to the provision of scientific and socio\u2013economic opinions and advice, for the purpose of sound and efficient fisheries management decisions under the CFP. 2. In particular, the following types of operations shall be eligible: (a) studies and pilot projects needed for the implementation and development of the CFP, including those on alternative types of sustainable fishing and aquaculture management techniques, including within Advisory Councils; (b) the preparation and provision of scientific opinions and advice by scientific bodies, including international advisory bodies in charge of stock assessments, by independent experts and by research institutions; (c) the participation of experts in the meetings of working groups on scientific and technical issues related to fisheries, such as STECF, as well as in international advisory bodies and in meetings where the contribution of fishery and aquaculture experts is required; (d) research surveys at sea, as referred to in Article 12(2) of Regulation (EC) No 199/2008, in areas where Union vessels operate under Sustainable fisheries partnership agreements as referred to in Article 31 of Regulation (EU) No 1380/2013; (e) expenditure incurred by the Commission for services related to the collection, management and use of data, to the organisation and management of fisheries expert meetings and the management of annual work programmes related to fisheries scientific and technical expertise, to the processing of data calls and datasets and to the preparatory work aiming at delivering scientific opinions and advice; (f) cooperation activities between Member States in the field of data collection, including those between the various regional stakeholders, and including the setting\u2013up and running of regionalised databases for the storage, management and use of data which will benefit regional cooperation and improve data collection and management activities as well as improving scientific expertise in support of fisheries management. Article 87 Control and enforcement 1. The EMFF may support the implementation of a Union control, inspection and enforcement system as provided for in Article 36 of Regulation (EU) No 1380/2013 and further specified in Regulation (EC) No 1224/2009. 2. In particular, the following types of operations shall be eligible: (a) joint purchase and/or chartering by several Member States belonging to the same geographical area, of patrol vessels, aircrafts and helicopters, provided that they are used for fisheries control for at least 60 % of the total period of use per year; (b) expenditure relating to the assessment and development of new control technologies, as well as of processes for the exchange of data; (c) all operational expenditure related to control and evaluation by the Commission of the implementation of the CFP, in particular that relating to verification, inspection and audit missions, equipment and training for Commission officials, the organisation of or participation in meetings, including the exchange of information and best practices between Member States, studies, IT services and suppliers, and the charter or purchase by the Commission of inspection means as specified in Titles IX and X of Regulation (EC) No 1224/2009. 3. With a view to strengthening and standardising controls, the EMFF may support the implementation of transnational projects that aim to develop and test the inter\u2013State control, inspection and enforcement systems provided for in Article 36 of Regulation (EU) No 1380/2013 and further laid down in Regulation (EC) No 1224/2009. Eligible types of operations shall include, in particular, the following: (a) international training programmes for personnel responsible for monitoring, control and surveillance of fisheries activities; (b) initiatives, including seminars and media tools, for standardising the interpretation of regulations and associated controls in the Union. 4. In the case of the operations referred to in point (a) of paragraph 2, only one of the Member States concerned shall be designated as a beneficiary. Article 88 Voluntary financial contributions to international organisations The EMFF may support the following types of operations in the area of international relations: (a) financial contributions provided to the United Nations organisations as well as voluntary funding provided to any international organisation active in the field of the Law of the Sea; (b) financial contributions to preparations for new international organisations or the preparation of new international treaties which are of interest to the Union; (c) financial contributions to work or programmes carried out by international organisations which are of special interest to the Union; (d) financial contributions to any activity (including working, informal or extraordinary meetings of contracting parties) which upholds the interests of the Union in international organisations and strengthens cooperation with its partners in those organisations. In that regard, when the presence of representatives of third countries in negotiations and meetings in international fora and organisations becomes necessary for the interests of the Union, the EMFF may bear the costs of their participation. Article 89 Advisory Councils 1. The EMFF shall support the operating costs of the Advisory Councils established in accordance with Article 43 of Regulation (EU) No 1380/2013. 2. An Advisory Council having legal personality may apply for Union support as a body pursuing an aim of general European interest. Article 90 Market intelligence The EMFF may support the development and dissemination of market intelligence for fishery and aquaculture products by the Commission in accordance with Article 42 of Regulation (EU) No 1379/2013. Article 91 Communication activities under the CFP and the IMP The EMFF may support: (a) the costs of information and communication activities linked to the CFP and the IMP, including: (i) the costs of the production, translation and dissemination of material tailored to the specific needs of the different target groups in written, audiovisual and electronic format; (ii) the costs of the preparation and organisation of events and meetings to inform, or collect the views of, the different parties concerned by the CFP and the IMP; (b) the travelling and accommodation costs of experts and stakeholders\u2019 representatives invited by the Commission to meetings; (c) the costs of the corporate communication of the political priorities of the Union as far as they are related to the general objectives of this Regulation. CHAPTER III Technical assistance Article 92 Technical assistance at the initiative of the Commission The EMFF may support, at the initiative of the Commission and subject to the ceiling of 1,1 % of the EMFF: (a) the measures of technical assistance specified in Article 58 of Regulation (EU) No 1303/2013; (b) the preparation, monitoring and evaluation of sustainable fisheries agreements and the Union participation in regional fisheries management organisations. The measures concerned shall consist of studies, meetings, expert involvement, temporary staff costs, information activities and any other administrative costs or costs arising from scientific or technical assistance by the Commission; (c) the setting-up of a European network of FLAGs aimed at capacity building, disseminating information, exchanging experiences and best practices and supporting cooperation between the FLAGs. That network shall cooperate with the networking and technical support bodies for local development set up by the ERDF, the ESF and the EAFRD as regards their local development activities and transnational cooperation. TITLE VII IMPLEMENTATION UNDER SHARED MANAGEMENT CHAPTER I General provisions Article 93 Scope This Title shall apply to measures financed under shared management as set out in Title V. CHAPTER II Delivery mechanism Section 1 Support from the EMFF Article 94 Determination of co-financing rates 1. When adopting implementing acts pursuant to Article 19 approving an operational programme, the Commission shall set the maximum EMFF contribution to that programme. 2. The EMFF contribution shall be calculated on the basis of the amount of eligible public expenditure. The operational programme shall establish the EMFF contribution rate applicable to the Union priorities set out in Article 6. The maximum EMFF contribution rate shall be 75 % and the minimum EMFF contribution rate shall be 20 % of eligible public expenditure. 3. By way of derogation from paragraph 2, the EMFF contribution shall be: (a) 100 % of the eligible public expenditure for the support under storage aid referred to in Article 67; (b) 100 % of the eligible public expenditure for the compensation regime referred to in Article 70; (c) 50 % of the eligible public expenditure for the support referred to in Articles 33, 34 and Article 41(2); (d) 70 % of the eligible public expenditure for the support referred to in point (e) of Article 76(2); (e) 90 % of the eligible public expenditure for the support referred to in points (a) to (d) and (f) to (l) of Article 76(2); (f) 80 % of the eligible expenditure for the support referred to in Article 77. 4. By way of derogation from paragraph 2, the maximum EMFF contribution rate applicable to the specific objectives under a Union priority shall be increased by ten percentage points, where the whole of the Union priority set out in Article 6(4) is delivered through community-led local development. Article 95 Intensity of public aid 1. Member States shall apply a maximum intensity of public aid of 50 % of the total eligible expenditure of the operation. 2. By way of derogation from paragraph 1, Member States may apply an intensity of public aid of 100 % of the eligible expenditure of the operation where: (a) the beneficiary is a public law body or an undertaking entrusted with the operation of services of general economic interest as referred to in Article 106(2) TFEU, where the aid is granted for the operation of such services; (b) the operation is related to the storage aid referred to in Article 67; (c) the operation is related to the compensation regime referred to in Article 70; (d) the operation is related to the data collection referred to in Article 77; (e) the operation is related to support under Article 33 or 34 or to compensation under Article 54, 55 or 56; (f) the operation is related to the IMP measures referred to in Article 80. 3. By way of derogation from paragraph 1, Member States may apply an intensity of public aid between 50 % and 100 % of the total eligible expenditure where: (a) the operation is implemented under Chapter I, II or IV of Title V and fulfils all of the following criteria: (i) it is of collective interest; (ii) it has a collective beneficiary; (iii) it has innovative features, where appropriate, at local level; (b) the operation is implemented under Chapter III of Title V, fulfils one of the criteria referred to in points (a)(i), (ii) or (iii) of this paragraph and provides public access to its results. 4. By way of derogation from paragraph 1, additional percentage points of public aid intensity shall apply for specific types of operations as set out in Annex I. 5. The Commission shall adopt implementing acts establishing how the different percentage points of public aid intensity shall apply in case several conditions of Annex I are fulfilled. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3). Article 96 Calculation of additional costs or income foregone Where aid is granted on the basis of additional costs or income foregone, Member States shall ensure that the relevant calculations are adequate, accurate and established in advance on the basis of a fair, equitable and verifiable calculation. CHAPTER III Management and control systems Article 97 Managing authority 1. In addition to the general rules set out in Article 125 of Regulation (EU) No 1303/2013, the managing authority shall: (a) by 31 March each year, provide the Commission with relevant cumulative data on operations selected for funding until the end of the previous calendar year, including key characteristics of the beneficiary and the operation itself; (b) ensure publicity for the operational programme by informing potential beneficiaries, professional organisations, the economic and social partners, bodies involved in promoting equality between men and women, and the non-governmental organisations concerned, including environmental organisations, of the possibilities offered by the programme and the rules for gaining access to programme funding; (c) ensure publicity for the operational programme by informing beneficiaries of the Union contribution and the general public of the role played by the Union in the programme. 2. The Commission shall adopt implementing acts laying down rules for the presentation of the data referred to in point (a) of paragraph 1. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 127(2). Article 98 Transmission of financial data 1. By 31 January and 31 July, the Member States shall transmit, by electronic means, to the Commission a forecast of the amount for which they expect to submit payment applications for the current and for the subsequent financial year. 2. The Commission shall adopt an implementing act establishing the model to be used when submitting the financial data to the Commission. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 127(3). CHAPTER IV Control by Member States Article 99 Financial corrections by Member States 1. In addition to the financial corrections referred to in Article 143 of Regulation (EU) No 1303/2013, Member States shall make financial corrections if the beneficiary does not respect the obligations referred to in Article 10(2) of this Regulation. 2. In the cases of financial corrections referred to in paragraph 1, Member States shall determine the amount of the correction, which shall be proportionate, having regard to the nature, gravity, duration and repetition of the infringement or offence by the beneficiary and the importance of the EMFF contribution to the economic activity of the beneficiary. CHAPTER V Control by the Commission Section 1 Interruption and suspension Article 100 Interruption of the payment deadline 1. In addition to the criteria allowing for interruption listed in points (a), (b) and (c) of Article 83(1) of Regulation (EU) No 1303/2013, the authorising officer by delegation, within the meaning of Regulation (EU, Euratom) No 966/2012, may interrupt the payment deadline for an interim payment claim in the case of non-compliance by a Member State with its obligations under the CFP which is liable to affect the expenditure contained in a certified statement of expenditure for which the interim payment is requested. 2. Prior to the interruption of an interim payment deadline as referred to in paragraph 1, the Commission shall, adopt implementing acts recognising that there is evidence suggesting non-compliance with obligations under the CFP. Before the Commission adopts such implementing acts, it shall immediately inform the Member State concerned of such evidence or reliable information and the Member State shall be given the opportunity to present its observations within a reasonable period of time. 3. The interruption of all or part of the interim payments related to the expenditure referred to in paragraph 1 covered by the payment claim shall be proportionate, having regard to the nature, gravity, duration and repetition of the non-compliance. Article 101 Suspension of payments 1. In addition to Article 142 of Regulation (EU) No 1303/2013, the Commission may adopt implementing acts suspending all or part of the interim payments under the operational programme in the case of a serious non-compliance by a Member State with its obligations under the CFP, which is liable to affect the expenditure contained in a certified statement of expenditure for which the interim payment is requested. 2. Prior to the suspension of an interim payment as referred to in paragraph 1, the Commission shall adopt an implementing act recognising that a Member State has failed to comply with its obligations under the CFP. Before the Commission adopts such an implementing act, it shall immediately inform the Member State concerned of such findings or reliable information and the Member State shall be given the opportunity to present its observations on the matter. 3. The suspension of all or part of the interim payments related to the expenditure referred to in paragraph 1 covered by the payment claim shall be proportionate, having regard to the nature, gravity, duration and repetition of the serious non-compliance. Article 102 Commission powers The Commission shall be empowered to adopt delegated acts, in accordance with Article 126, defining those cases of non-compliance, referred to in Article 100, and the cases of serious non-compliance, referred to in Article 101(1), deriving from the relevant CFP rules that are essential to the conservation of marine biological resources. Section 2 Information exchange and financial corrections Article 103 Access to information On request by the Commission, Member States shall communicate to the Commission the laws, regulations and administrative provisions which they have adopted for implementing Union acts relating to the CFP, where those acts have a financial impact on the EMFF. Article 104 Confidentiality 1. Member States and the Commission shall take all necessary steps to ensure the confidentiality of the information communicated or obtained during on-the-spot controls or in the context of the clearance of accounts implemented pursuant to this Regulation. 2. The principles referred to in Article 8 of Council Regulation (Euratom, EC) No 2185/96 (39) shall apply to the information referred to in paragraph 1 of this Article. Article 105 Financial corrections by the Commission 1. In addition to the cases referred to in Article 22(7), Article 85 and Article 144(1) of Regulation (EU) No 1303/2013, the Commission shall adopt implementing acts making financial corrections by cancelling all or part of the Union contribution to an operational programme if, after carrying out the necessary examination, it concludes that: (a) expenditure contained in a certified statement of expenditure is affected by cases in which the beneficiary does not respect the obligations referred to in Article 10(2) of this Regulation and has not been corrected by the Member State prior to the opening of the correction procedure under this paragraph; (b) expenditure contained in a certified statement of expenditure is affected by cases of serious non-compliance with the CFP rules by the Member State which have resulted in the suspension of payment under Article 101 of this Regulation and where the Member State concerned still fails to demonstrate that it has taken the necessary remedial action to ensure compliance with and the enforcement of applicable rules in the future. 2. The Commission shall decide on the amount of the correction taking into account the nature, gravity, duration and repetition of the serious non-compliance by the Member State or beneficiary with the CFP rules and the importance of the EMFF contribution to the economic activity of the beneficiary concerned. 3. Where it is not possible to quantify precisely the amount of expenditure linked to non-compliance with the CFP rules by the Member State, the Commission shall apply a flat rate or extrapolated financial correction in accordance with paragraph 4. 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 126, determining the criteria for establishing the level of financial correction to be applied and the criteria for applying flat rates or extrapolated financial corrections. Article 106 Procedure Article 145 of Regulation (EU) No 1303/2013 shall apply mutatis mutandis where the Commission proposes a financial correction referred to in Article 105 of this Regulation. CHAPTER VI Monitoring, evaluation, information and communication Section 1 Establishment and objectives of a common monitoring and evaluation system Article 107 Monitoring and evaluation system 1. A common monitoring and evaluation system for EMFF operations under shared management shall be established with a view to measuring the performance of the EMFF. In order to ensure an effective performance measurement, the Commission shall be empowered to adopt delegated acts, in accordance with Article 126, defining the content and construction of that system. 2. The general impact of the EMFF shall be considered in relation to the Union priorities set out in Article 6. The Commission may adopt implementing acts establishing the set of indicators specific to those Union priorities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3). 3. Member States shall provide the Commission with all the information necessary to permit the monitoring and evaluation of the measures concerned. The Commission shall take into account the data needs and synergies between potential data sources, in particular their use for statistical purposes when appropriate. The Commission shall adopt implementing acts laying down rules on the information to be sent by Member States, as well as on the data needs and synergies between potential data sources. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3). 4. The Commission shall present a report on the implementation of this Article to the European Parliament and to the Council every four years. The first report shall be presented by 31 December 2017. Article 108 Objectives The objectives of the common monitoring and evaluation system shall be: (a) to demonstrate the progress and achievements of the CFP and the IMP, to consider the general impact and to assess the effectiveness, efficiency and relevance of EMFF operations; (b) to contribute to better targeted support for the CFP and the IMP; (c) to support a common learning process related to monitoring and evaluation; (d) to provide robust, evidenced based evaluations of the EMFF operations that feed into the decision-making process. Section 2 Technical provisions Article 109 Common indicators 1. A list of common indicators relating to the initial situation as well as to the financial execution, outputs and results of the operational programme and applicable to each operational programme shall be specified in the monitoring and evaluation system provided for in Article 107 to allow for aggregation of data at Union level. 2. The common indicators shall be linked to the milestones and targets established in the operational programmes in accordance with the Union priorities set out in Article 6. Those common indicators shall be used for the performance review referred to in Article 21(1) of Regulation (EU) No 1303/2013, and shall allow assessment of the progress, efficiency and effectiveness of policy implementation against objectives and targets at Union and programme level. Article 110 Electronic information system 1. Key information on the implementation of the operational programme, on each operation selected for funding, as well as on completed operations, needed for monitoring and evaluation, including the key characteristics of the beneficiary and the project, shall be recorded and maintained electronically. 2. The Commission shall ensure that there is an appropriate secure electronic system to record, maintain and manage key information and report on monitoring and evaluation. Article 111 Provision of information Beneficiaries of support under EMFF, including FLAGs, shall undertake to provide to the managing authority and/or to appointed evaluators or other bodies to which the performance of functions on its behalf is delegated, all the data and information necessary to permit monitoring and evaluation of the operational programme, in particular in relation to meeting specific objectives and priorities. Section 3 Monitoring Article 112 Monitoring procedures 1. The managing authority referred to in Article 97 of this Regulation and the monitoring committee referred to in Article 47 of Regulation (EU) No 1303/2013 shall monitor the quality of programme implementation. 2. The managing authority and the monitoring committee shall carry out monitoring of the operational programme by means of financial, output and result indicators. Article 113 Functions of the monitoring committee In addition to the functions provided for in Article 49 of Regulation (EU) No 1303/2013, the monitoring committee shall verify the performance of the operational programme and the effectiveness of its implementation. For that purpose, the monitoring committee shall: (a) be consulted and shall approve, within six months of the decision approving the programme, the selection criteria for the financed operations; the selection criteria shall be revised in accordance with programming needs; (b) examine the activities and outputs related to the evaluation plan of the programme; (c) examine actions in the programme relating to the fulfilment of specific ex ante conditionalities; (d) examine and approve the annual implementation reports before they are sent to the Commission; (e) examine actions to promote equality between men and women, equal opportunities, and non-discrimination, including accessibility for disabled persons. The monitoring committee shall not be consulted on the work plans for data collection referred to in Article 21. Article 114 Annual implementation report 1. By 31 May 2016, and by 31 May of each subsequent year up to and including 2023, Member States shall submit to the Commission an annual implementation report on the implementation of the operational programme in the previous calendar year. The report submitted in 2016 shall cover the calendar years 2014 and 2015. 2. In addition to the provisions of Article 50 of Regulation (EU) No 1303/2013, annual implementation reports shall include: (a) information on financial commitments and expenditure by measure; (b) a summary of the activities undertaken in relation to the evaluation plan; (c) information on the actions taken in cases of serious infringements as referred to in Article 10(1) of this Regulation, and of non-respect of the conditions laid down in Article 10(2) of this Regulation, as well as on remedy actions; (d) information on actions taken to comply with Article 41(10) of this Regulation.; (e) information on the actions taken to ensure the publication of beneficiaries in accordance with Annex V to this Regulation, for natural persons in accordance with national law, including any applicable threshold. 3. The Commission shall adopt implementing acts laying down rules concerning the format and presentation of the annual implementation reports. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3). Section 4 Evaluation Article 115 General provisions 1. The Commission shall adopt implementing acts laying down the elements to be contained in ex ante evaluation reports referred to in Article 55 of Regulation (EU) No 1303/2013 and establishing the minimum requirements for the evaluation plan referred to in Article 56 of that Regulation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3) of this Regulation. 2. Member States shall ensure that the evaluations conform to the common monitoring and evaluation system agreed in accordance with Article 107, shall organise the production and gathering of the necessary data, and shall supply the various pieces of information provided by the monitoring system to the evaluators. 3. The evaluation reports shall be made available by Member States on the internet and by the Commission on the Union website. Article 116 Ex ante evaluation Member States shall ensure that the ex ante evaluator is involved from an early stage in the process of development of the operational programme, including the development of the analysis referred to in point (a) of Article 18(1), the design of the programme\u2019s intervention logic and the establishment of the programme\u2019s targets. Article 117 Ex post evaluation In accordance with Article 57 of Regulation (EU) No 1303/2013, an ex post evaluation report shall be prepared by the Commission in close cooperation with Member States. Article 118 Synthesis of evaluations A synthesis at Union level of the ex ante evaluation reports shall be undertaken under the responsibility of the Commission. The synthesis of the evaluation reports shall be completed at the latest by 31 December of the year following the submission of the relevant evaluations. Section 5 Information and communication Article 119 Information and publicity 1. The managing authority shall be responsible in accordance with point (b) of Article 97(1) for: (a) ensuring the establishment of a single website or a single website portal providing information on, and access to, the operational programme in the Member State; (b) informing potential beneficiaries about funding opportunities under the operational programme; (c) publicising to Union citizens the role and achievements of the EMFF through information and communication actions on the results and impact of partnership agreements, operational programmes and operations; (d) ensuring that a summary of measures designed to ensure compliance with the CFP rules, including cases of non-compliance by Member States or beneficiaries, as well as of remedy actions such as financial corrections taken, is made publicly available. 2. In order to ensure transparency concerning the support from the EMFF, Member States shall maintain a list of operations in CSV or XML format which shall be accessible through the single website or the single website portal, providing a list of operations and a summary of the operational programme. The list of operations shall be updated at least every six months. The minimum information to be set out in the list of operations, including specific information concerning operations under Articles 26, 39, 47, 54 and 56, is laid down in Annex V. 3. Detailed rules concerning the information and publicity measures for the public and information measures for applicants and beneficiaries are laid down in Annex V. 4. The Commission shall adopt implementing acts laying down the technical characteristics of information and publicity measures for the operation, instructions for creating the emblem and a definition of the standard colours. Those implementing acts shall be adopted in accordance with the advisory procedure referred to Article 127(2). TITLE VIII IMPLEMENTATION UNDER DIRECT MANAGEMENT CHAPTER I General provisions Article 120 Scope This Title shall apply to measures financed under direct management as set out in Title VI. CHAPTER II Control Article 121 Protection of Union financial interests 1. The Commission shall take appropriate measures to ensure that, when operations financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective proportionate and dissuasive penalties. 2. The Commission or its representatives and the Court of Auditors shall have the power of audit, both on the basis of documents and on-the-spot checks, over all beneficiaries, contractors and sub-contractors who have received Union funds. The European Anti-Fraud Office (OLAF) may carry out on-the-spot checks and inspections on economic operators concerned directly or indirectly by Union funding, in accordance with the procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (40) and in Regulation (Euratom, EC) No 2185/96, with a view to establishing whether fraud, corruption or any other illegal activity has occurred affecting the financial interests of the Union in connection with a grant agreement, grant decision or a contract concerning Union funding. 3. Without prejudice to paragraphs 1 and 2, cooperation agreements with third countries and international organisations, grant agreements, grant decisions and contracts resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct the audits, on-the-spot checks and inspections referred to in those paragraphs, in accordance with their respective competences. Article 122 Audits 1. Officials of the Commission and of the Court of Auditors, or their representatives, may carry out on-the-spot audits on operations financed by this Regulation at any time with a notice of at least ten working days, except in urgent cases, for a period of up to three years after the final payment made by the Commission. 2. Officials of the Commission and of the Court of Auditors, or their representatives, duly empowered to carry out on-the-spot audits, shall have access to the books and all other documents, including documents and metadata drawn-up or received and recorded in an electronic format relating to expenditure financed under this Regulation. 3. The powers of audit referred to in paragraph 2 shall not affect the application of national provisions which reserve certain acts for agents specifically designated by national legislation. Officials of the Commission and of the Court of Auditors, or their representatives, shall not take part, inter alia, in home visits or the formal questioning of persons within the framework of the national legislation of the Member State concerned. However, they shall have access to information thereby obtained. 4. If any Union financial support granted under this Regulation is subsequently allocated to a third party as a final beneficiary, the initial beneficiary, being the recipient of the Union financial support, shall provide the Commission with all relevant information regarding the identity of that final beneficiary. Article 123 Suspension of payments, reduction and cancellation of the financial contribution 1. If the Commission considers that Union funds have not been used in accordance with the conditions laid down in this Regulation or in any other applicable Union legal act, it shall notify the beneficiaries who shall have one month from the date of such notification to provide the Commission with their observations. 2. If the beneficiaries do not reply within the period referred to in paragraph 1 of this Article or if their observations are not considered satisfactory, the Commission shall reduce or cancel the financial contribution granted or suspend the payments. Any amount unduly paid shall be repaid to the general budget of the Union. Interest shall be added to any sums not repaid in due time under the conditions laid down in Regulation (EU, Euratom) No 966/2012. CHAPTER III Evaluation and reporting Article 124 Evaluation 1. Operations financed under this Regulation shall be monitored regularly in order to follow their implementation. 2. The Commission shall ensure the regular, independent, external evaluation of the operations financed. Article 125 Reporting The Commission shall submit to the European Parliament and the Council: (a) by 31 March 2017, an interim evaluation report on the results obtained and the qualitative and quantitative aspects of the implementation of the operations financed under this Regulation; (b) by 31 August 2018, a communication on the continuation of the operations financed under this Regulation. TITLE IX PROCEDURAL PROVISIONS Article 126 Exercise of delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 10, 14, 32, 40, 41, 72, 102, 105, 107 and 129 shall be conferred until 31 December 2020. 3. The delegation of power referred to in Articles 10, 14, 32, 40, 41, 72, 102, 105, 107 and 129 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 10, 14, 32, 40, 41, 72, 102, 105, 107 and 129 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. Article 127 Committee procedure 1. The Commission shall be assisted by a Committee for the European Maritime and Fisheries Fund. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion on a draft implementing act to be adopted pursuant to Article 95(5) of this Regulation, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. TITLE X FINAL PROVISIONS Article 128 Repeal 1. Without prejudice to the provisions of Article 129(2), Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006, (EC) No 791/2007, (EU) No 1255/2011 and Article 103 of Regulation (EC) No 1224/2009 are repealed with effect from 1 January 2014. 2. References to the repealed Regulations shall be construed as references to this Regulation. Article 129 Transitional provisions 1. In order to facilitate the transition from the support schemes established by Regulations (EC) No 861/2006, (EC) No 1198/2006, (EC) No 791/2007 and (EU) No 1255/2011 to the scheme established by this Regulation, the Commission shall be empowered to adopt delegated acts, in accordance with Article 126, laying down the conditions under which support approved by the Commission under those Regulations may be integrated into support provided for under this Regulation, including for technical assistance and for the ex post evaluations. 2. This Regulation shall not affect the continuation or modification, including the total or partial cancellation, of the projects concerned, until their closure, or of assistance approved by the Commission on the basis of Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006, (EC) No 791/2007 and (EU) No 1255/2011 and Article 103 of Regulation (EC) No 1224/2009 or any other legislation applying to that assistance on 31 December 2013, which shall continue to apply to such projects or assistance. 3. Applications made under Regulation (EC) No 1198/2006 shall remain valid. Article 130 Entry into force and date of application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 May 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 299, 4.10.2012, p. 133 and OJ C 271, 19.9.2013, p. 154. (2) OJ C 391, 18.12.2012, p. 84. (3) Position of the European Parliament of 16 April 2014 (not yet published in the Official Journal) and decision of the Council of 8 May 2014. (4) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (5) Council Regulation (EC) No 2328/2003 of 22 December 2003 introducing a scheme to compensate for the additional costs incurred in the marketing of certain fishery products from the Azores, Madeira, the Canary Islands and the French departments of Guiana and R\u00e9union, as a result of those regions\u2019 remoteness (OJ L 345, 31.12.2003, p. 34). (6) Council Regulation (EC) No 861/2006 of 22 May 2006 establishing Community financial measures for the implementation of the Common Fisheries Policy and in the area of the Law of the Sea (OJ L 160, 14.6.2006, p. 1). (7) Council Regulation (EC) No 1198/2006 of 27 July 2006 on the European Fisheries Fund (OJ L 223, 15.8.2006, p. 1). (8) Council Regulation (EC) No 791/2007 of 21 May 2007 introducing a scheme to compensate for the additional costs incurred in the marketing of certain fishery products from the outermost regions the Azores, Madeira, the Canary Islands, French Guiana and R\u00e9union (OJ L 176, 6.7.2007, p. 1). (9) Regulation (EU) No 1255/2011 of the European Parliament and of the Council of 30 November 2011 establishing a Programme to support the further development of an Integrated Maritime Policy (OJ L 321, 5.12.2011, p. 1). (10) The United Nations Convention on the Law of the Sea and of the Agreement on the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 3). (11) Regulation (EU) No 1303/2013 of the European Parliament and the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (OJ L 347, 20.12.2013, p. 320). (12) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (13) Council Regulation (EC) No 199/2008 of 25 February 2008 concerning the establishment of a Community framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the Common Fisheries Policy (OJ L 60, 5.3.2008, p. 1). (14) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, p. 1). (15) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (16) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 \u2014 the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104). (17) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (18) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (19) Recommendation 2002/413/EC of the European Parliament and of the Council of 30 May 2002 concerning the implementation of Integrated Coastal Zone Management in Europe (OJ L 148, 6.6.2002, p. 24). (20) Commission Regulation (EC) No 26/2004 of 30 December 2003 on the Community fishing fleet register (OJ L 5, 9.1.2004, p. 25). (21) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (22) Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28). (23) Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities\u2019 financial interests (OJ C 316, 27.11.1995, p. 49). (24) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (25) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). (26) Directive 2010/41/EU of the European Parliament and of the Council of 7 July 2010 on the application of the principle of equal treatment between men and women engaged in an activity in a self-employed capacity and repealing Council Directive 86/613/EEC (OJ L 180, 15.7.2010, p. 1). (27) Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, p. 11). (28) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). (29) Commission Decision 2005/629/EC of 26 August 2005 establishing a Scientific, Technical and Economic Committee for Fisheries (OJ L 225, 31.8.2005, p. 18). (30) Directive 60/2000/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (31) Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30). (32) Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14). (33) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1). (34) Commission Regulation (EC) No 710/2009 of 5 August 2009 amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007, as regards laying down detailed rules on organic aquaculture animal and seaweed production (OJ L 204, 6.8.2009, p. 15). (35) Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (OJ L 114, 24.4.2001, p. 1). (36) Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field (OJ L 155, 18.6.2009, p. 30). (37) Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1). (38) Council Regulation (EC) No 768/2005 of 26 April 2005 establishing a Community Fisheries Control Agency and amending Regulation (EEC) No 2847/93 establishing a control system applicable to the common fisheries policy (OJ L 128, 21.5.2005, p. 1). (39) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities\u2019 financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (40) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). ANNEX I SPECIFIC AID INTENSITY Type of operations Percentage points Operations related to small\u2013scale coastal fisheries may benefit from an increase by 30 Operations located in the remote Greek Islands and in the Croatian islands of Dugi Otok, Vis, Mljet and Lastovo may benefit from an increase by 35 Operations located in the outermost regions may benefit from an increase by 35 Operations implemented by organisations of fishermen or other collective beneficiaries outside Chapter III of Title V may benefit from an increase by 10 Operations implemented by producer organisations, associations of producer organisations or interbranch organisations may benefit from an increase by 25 Operations under Article 76 on control and enforcement may benefit from an increase by 30 Operations under Article 76 on control and enforcement related to small\u2013scale coastal fisheries may benefit from an increase by 40 Operations under Article 41(2) concerning replacement or modernisation of main or ancillary engines shall be reduced by 20 Operations implemented by enterprises that fall outside the definition of SMEs shall be reduced by 20 ANNEX II ANNUAL BREAKDOWN OF COMMITMENT APPROPRIATIONS FOR 2014 TO 2020 Description Period 2014 2015 2016 2017 2018 2019 2020 Total EMFF shared management (2014-2020) 788 060 689 798 128 031 805 423 852 818 478 098 837 523 233 843 250 018 858 467 679 5 749 331 600 ANNEX III INDICATIVE DISTRIBUTION OF FUNDS UNDER CHAPTERS I AND II OF TITLE VI AMONG THE OBJECTIVES SET OUT IN ARTICLES 82 AND 85 (1) Objectives set out in Article 82: 1. Development and implementation of an integrated governance of maritime and coastal affairs \u2013 5 % 2. Development of cross-sectorial initiatives \u2013 33 % 3. Support for sustainable economic growth, employment, innovation and new technologies \u2013 2 % 4. Promotion of the protection of the marine environment \u2013 5 % Objectives set out in Article 85: 1. Collection, management and dissemination of scientific advice under the CFP \u2013 11 % 2. Specific control and enforcement measures under the CFP \u2013 19 % 3. Voluntary contributions to international organisations \u2013 10 % 4. Advisory Councils and communication activities under the CFP and the IMP \u2013 9 % 5. Market intelligence, including the establishment of electronic markets \u2013 6 % (1) The percentages apply to the amount set out in Article 14 excluding the allocation under Article 92. ANNEX IV SPECIFIC EX ANTE CONDITIONALITIES Specific objective under the Union priority for EMFF/thematic objective (TO) Ex ante conditionality Criteria for fulfilment EMFF priority: 1. Promoting environmentally sustainable, resource efficient, innovative, competitive and knowledge\u2013based fisheries. Specific objectives: (a) - (f). TO 3: enhancing the competitiveness of SMEs, of the agricultural sector (for the EAFRD) and of the fishery and aquaculture sector (for the EMFF); TO 6: preserving and protecting the environment and promoting resource efficiency; TO 8: promoting sustainable and quality employment and supporting labour mobility. Report on fishing capacity has been submitted in accordance with Article 22(2) of Regulation (EU) No 1380/2013. The report is made in accordance with common guidelines issued by the Commission Fishing capacity does not exceed the fishing capacity ceiling set up in Annex II to Regulation (EU) No 1380/2013 EMFF priority: 2. Fostering environmentally sustainable, resource efficient, innovative, competitive and knowledge\u2013based aquaculture. Specific objectives: (a), (b) and (c). TO 3: enhancing the competitiveness of SMEs, of the agricultural sector (for the EAFRD) and of the fishery and aquaculture sector (for the EMFF); TO 6: preserving and protecting the environment and promoting resource efficiency; TO 8: promoting sustainable and quality employment and supporting labour mobility. The establishment of a multiannual national strategic plan on aquaculture, as referred to in Article 34 of Regulation (EU) No 1380/2013, by 2014. A multiannual national strategic plan on aquaculture is transmitted to the Commission at the latest by the day of transmission of the operational programme The operational programme includes information on the complementarities with the multiannual national strategic plan on aquaculture EMFF priority: 3. Fostering the implementation of the CFP. Specific objective (a). TO 6: preserving and protecting the environment and promoting resource efficiency. Administrative capacity: administrative capacity is available to comply with the data requirements for fisheries management set out in Article 25 of Regulation (EU) No 1380/2013 and Article 4 of Regulation (EC) No 199/2008. A description of the administrative capacity to prepare and apply a multiannual programme for data collection, to be reviewed by STECF and accepted by the Commission A description of the administrative capacity to prepare and implement work plans for data collection, to be reviewed by STECF and accepted by the Commission A description of the capacity in human resources allocation to undertake bilateral or multilateral agreements with other Member States if the work to implement the data collection obligations is shared EMFF priority: 3. Fostering the implementation of the CFP. Specific objective (b). TO 6: preserving and protecting the environment and promoting resource efficiency. Administrative capacity: administrative capacity is available to comply with the implementation of a Union control, inspection and enforcement system as provided for in Article 36 of Regulation (EU) No 1380/2013 and further specified in Regulation (EC) No 1224/2009. The specific actions include: A description of the administrative capacity to prepare and implement the section of the operational programme pertaining to the 2014-2020 national control financing programme as referred to in point (o) of Article 18(1) A description of the administrative capacity to prepare and implement the national control action programme for multiannual plans, as provided for in Article 46 of Regulation (EC) No 1224/2009 A description of the administrative capacity to prepare and implement a common control programme that may be developed with other Member States, as provided for in Article 94 of Regulation (EC) No 1224/2009 A description of the administrative capacity to prepare and implement the specific control and inspection programmes, as provided for in Article 95 of Regulation (EC) No 1224/2009 A description of the administrative capacity to apply a system of effective, proportionate and dissuasive sanctions for serious infringements, as provided for in Article 90 of Regulation (EC) No 1224/2009 A description of the administrative capacity to apply the point system for serious infringements, as provided for in Article 92 of Regulation (EC) No 1224/2009 ANNEX V INFORMATION AND COMMUNICATION ON SUPPORT FROM THE EMFF 1. List of operations The list of operations referred to in Article 119 shall contain, in at least one of the official languages of the Member State, the following data fields: \u2014 beneficiary name (only legal entities and natural persons in accordance with national law); \u2014 Community fleet register (CFR) identification number as referred to in Article 10 of Regulation (EC) No 26/2004 (to be completed only where the operation is linked to a fishing vessel); \u2014 operation name; \u2014 operation summary; \u2014 operation start date; \u2014 operation end date (expected date for physical completion or full implementation of the operation); \u2014 total eligible expenditure; \u2014 amount of Union contribution; \u2014 operation postcode; \u2014 country; \u2014 name of Union priority; \u2014 date of the last update of the list of operations. 2. Information and publicity measures for the public 1. The Member State shall ensure that the information and publicity measures aim at the widest possible media coverage using various forms and methods of communication at the appropriate level. 2. The Member State shall be responsible for organising at least the following information and publicity measures: (a) a major information activity publicising the launch of the operational programme; (b) at least twice during the programming period major information activity which promotes the funding opportunities and the strategies pursued and presents the achievements of the operational programme; (c) displaying the flag or emblem, as appropriate, of the Union in front of, or at a place visible to the public, at the premises of each managing authority; (d) publishing electronically the list of operations in accordance with section 1; (e) giving examples of operations, by operational programme, on the single website or on the operational programme\u2019s website that is accessible through the single website portal; the examples should be in a widely spoken official language of the Union other than the official language or languages of the Member State concerned; (f) ensuring that a specific section of the single website is dedicated to give a short summary of innovation and eco-innovation operations; (g) updating information about the operational programme\u2019s implementation, including its main achievements, on the single website or on the operational programme\u2019s website that is accessible through the single website portal; (h) ensuring that a summary of measures designed to ensure compliance with the CFP rules, including cases of non-compliance by Member States or beneficiaries, as well as of remedy actions such as financial corrections taken, is made publicly available. 3. The managing authority shall involve in information and publicity measures, in accordance with national laws and practices, the following bodies: (a) the partners referred to in Article 5 of Regulation (EU) No 1303/2013; (b) information centres on Europe, as well as Commission representation offices in Member States; (c) educational and research institutions. Those bodies shall widely disseminate the information referred to in points (a) and (b) of Article 119(1). 3. Information measures for potential beneficiaries and beneficiaries 3.1. Information measures for potential beneficiaries 1. The managing authority shall ensure that the operational programme\u2019s objectives and funding opportunities offered by the EMFF are disseminated widely to potential beneficiaries and all interested parties. 2. The managing authority shall ensure that potential beneficiaries are informed of at least the following: (a) the conditions of eligibility of expenditure to be met in order to qualify for support under an operational programme; (b) a description of the admissibility conditions for applications, procedures for examining applications for funding and of the time periods involved; (c) the criteria for selecting the operations to be supported; (d) the contacts at national, regional or local level that are able to provide information on the operational programmes; (e) that applications should propose communication activities, proportionate to the size of the operation, in order to inform the public about the operation\u2019s aims and the Union support to the operation. 3.2. Information measures for beneficiaries The managing authority shall inform beneficiaries that acceptance of funding constitutes an acceptance of their inclusion in the list of operations published in accordance with Article 119(2).", "summary": "European Maritime and Fisheries Fund (2014-2020) European Maritime and Fisheries Fund (2014-2020) SUMMARY OF: Regulation (EU) No 508/2014 \u2014 the European Maritime and Fisheries Fund WHAT IS THE AIM OF THE REGULATION? The European Maritime and Fisheries Fund (EMFF) aims to help coastal populations and those working in the fishing and aquaculture sectors to adapt to the newly reformed EU common fisheries policy (CFP) for the period 2014-2020. KEY POINTS Budget and priorities With a budget of \u20ac6.5 billion for the 2014-2020 period, the EMFF aims to: rebuild fish stocks, reduce the impact of fishing on the marine environment and gradually eliminate discards \u2014 the dumping at sea of unwanted catches \u2014 returning fish to the sea either dead or alive because they are too small, because the fisherman has no quota to catch them or because of certain catch composition rules; support small-scale, local fishing and young fishermen; help communities to diversify their local economy; fund projects that will create jobs and improve the quality of life on Europe\u2019s coasts; support European aquaculture (fish and shellfish farming); finance the improvement of scientific knowledge of the marine environment and the collection of relevant data so that decisions are taken based on reliable information; strengthen fishery control programmes; support innovative investments in fishing vessels, for example, to improve fishing gear selectivity (gear that targets and captures fish by size and species and allows other fish to be avoided or to be released unharmed); support (under certain conditions) investments in equipment or on board aimed at reducing the emission of pollutants or greenhouse gases; improve the marketing and processing in the fisheries and aquaculture sectors; support the EU\u2019s integrated maritime policy by facilitating coordination across borders and between sectors (for example maritime spatial planning, integrated maritime surveillance and improving knowledge on the state of the marine environment). Implementation The EMFF co-finances projects with EU countries that provide national funding. EU countries draw up an operational programme stating how they intend to spend the money allocated. Once the European Commission approves these programmes, it is up to the national authorities to decide which projects will be funded. Since the adoption of Regulation (EU) No 508/2014, the Commission has adopted rules mainly dealing with detailed technical aspects of its implementation. These include: how EU countries should present cumulative data on fishing operations and the information that they need to provide to the Commission;the contents and setting up of a system to monitor and evaluate the operations that receive funding;the format and presentation of annual reports of funded programmes;detailed conditions on interrupting and suspending of payments to EU countries that do not comply with the CFP rules. A full list of implementing and delegated acts is available on the EMFF website. COVID-19 pandemic \u2014 amendment to the regulation Regulation (EU) 2020/560 amends Regulation (EU) No 508/2014 introducing specific measures to mitigate the impact of the COVID-19 pandemic. There has been a significant drop in demand for fishery and aquaculture products following the outbreak with serious socio-economic consequences in those communities where fishing and aquaculture play a major role. The amended regulation allows the EMFF to provide support for: the temporary cessation of fishing activities, including for inland fishing and fishermen on foot;certain economic losses for aquaculture producers and processing enterprises and in the outermost regions, if they are due to the COVID\u201019 outbreak. The measures may also involve providing working capital to aquaculture producers and processing enterprises, and support for producer organisations and associations of producer organisations for the storage of fishery and aquaculture products. This regulation also allows a more flexible reallocation of financial resources within the operational programme of each EU country and simplifies the procedure for amending operational programmes. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. The temporary measures related to the COVID-19 outbreak apply retroactively as of 1 February 2020 and are available until 31 December 2020. BACKGROUND The EMFF is the financial instrument supporting the CFP for the 2014-2020 period. It is one of the 5 European Structural and Investment Funds that complement each other and aim to promote a recovery in Europe based on growth and jobs. MAIN DOCUMENT Regulation (EU) No 508/2014 of the European Parliament and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council (OJ L 149, 20.5.2014, pp. 1-66) Successive amendments to Regulation (EU) No 508/2014 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2015/852 of 27 March 2015 supplementing Regulation (EU) No 508/2014 of the European Parliament and of the Council as regards the cases of non-compliance and the cases of serious non-compliance with the rules of the common fisheries policy that may lead to an interruption of a payment deadline or suspension of payments under the European Maritime and Fisheries Fund (OJ L 135, 2.6.2015, pp. 13-17) Commission Implementing Regulation (EU) No 1362/2014 of 18 December 2014 laying down rules on a simplified procedure for the approval of certain amendments to operational programmes financed under the European Maritime and Fisheries Fund and rules concerning the format and presentation of the annual reports on the implementation of those programmes (OJ L 365, 19.12.2014, pp. 124-136) Commission Implementing Regulation (EU) No 1243/2014 of 20 November 2014 laying down rules pursuant to Regulation (EU) No 508/2014 of the European Parliament and of the Council on the European Maritime and Fisheries Fund with regard to the information to be sent by Member States, as well as on data needs and synergies between potential data sources (OJ L 334, 21.11.2014, pp. 39-51) See consolidated version. Commission Implementing Regulation (EU) No 1242/2014 of 20 November 2014 laying down rules pursuant to Regulation (EU) No 508/2014 of the European Parliament and of the Council on the European Maritime and Fisheries Fund with regard to the presentation of relevant cumulative data on operations (OJ L 334, 21.11.2014, pp. 11-38) Commission Delegated Regulation (EU) No 1014/2014 of 22 July 2014 supplementing Regulation (EU) No 508/2014 of the European Parliament and of the Council on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council with regards to the content and construction of a common monitoring and evaluation system for the operations funded under the European Maritime and Fisheries Fund (OJ L 283, 27.9.2014, pp. 11-19) See consolidated version. Commission Implementing Regulation (EU) No 763/2014 of 11 July 2014 laying down rules for applying Regulation (EU) No 508/2014 of the European Parliament and of the Council on the European Maritime and Fisheries Fund as regards the technical characteristics of information and publicity measures and instructions for creating the Union emblem (OJ L 209, 16.7.2014, pp. 1-4) Commission Implementing Decision 2014/372/EU of 11 June 2014 setting out the annual breakdown by Member State of the global resources of the European Maritime and Fisheries Fund available in the framework of shared management for the period 2014-2020 (notified under document C(2014) 3781) (OJ L 180, 20.6.2014, pp. 18-20) last update 09.06.2020"}
{"article": "9.12.2014 EN Official Journal of the European Union L 352/1 REGULATION (EU) No 1286/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the ordinary legislative procedure, Whereas: (1) Retail investors are increasingly offered a wide variety of packaged retail and insurance-based investment products (PRIIPs) when they consider making an investment. Some of these products provide specific investment solutions tailored to the needs of retail investors, are frequently combined with insurance coverage or can be complex and difficult to understand. Existing disclosures to retail investors for such PRIIPs are uncoordinated and often do not help retail investors to compare different products, or understand their features. Consequently, retail investors have often made investments without understanding the associated risks and costs and have, on occasion, suffered unforeseen losses. (2) Improving the transparency of PRIIPs offered to retail investors is an important investor protection measure and a precondition for rebuilding the confidence of retail investors in the financial market, in particular in the aftermath of the financial crisis. First steps in this direction have already been taken at Union level through the development of the key investor information regime established by Directive 2009/65/EC of the European Parliament and of the Council (3). (3) The existence of different rules on PRIIPs, that vary according to the industry offering the PRIIPs and differences in national regulation in this area create an unlevel playing field between different products and distribution channels, erecting additional barriers to an internal market in financial services and products. Member States have already taken divergent and uncoordinated action to address shortcomings in investor protection measures and it is likely that this development would continue. Divergent approaches to disclosures relating to PRIIPs impede the development of a level playing field between different PRIIP manufacturers and those advising on, or selling, these products, and thus distort competition and lead to unequal levels of investor protection within the Union. Such divergence represents an obstacle to the establishment and smooth functioning of the internal market. (4) To prevent divergence, it is necessary to establish uniform rules on transparency at Union level which will apply to all participants in the PRIIPs market and thereby enhance investor protection. A regulation is necessary to ensure that a common standard for key information documents is established in a uniform fashion so as to be able to harmonise the format and the content of those documents. The directly applicable rules of a regulation should ensure that all those advising on, or selling, PRIIPs are subject to uniform requirements in relation to the provision of the key information document to retail investors. This Regulation has no effect on the supervision of advertising documents. Moreover, it has no effect on product intervention measures other than in relation to insurance-based investment products. (5) Whilst improving disclosures relating to PRIIPs is essential in rebuilding the trust of retail investors in the financial markets, effectively regulated sales processes for those products are equally important. This Regulation is complementary to measures on distribution in Directive 2014/65/EU of the European Parliament and of the Council (4). It is also complementary to measures taken on the distribution of insurance products in Directive 2002/92/EC of the European Parliament and of the Council (5). (6) This Regulation should apply to all products, regardless of their form or construction, that are manufactured by the financial services industry to provide investment opportunities to retail investors, where the amount repayable to the retail investor is subject to fluctuation because of exposure to reference values, or subject to the performance of one or more assets which are not directly purchased by the retail investor. Those products should be known as PRIIPs for the purposes of this Regulation and should include, among other things, investment products such as investment funds, life insurance policies with an investment element, structured products and structured deposits. Financial instruments issued by special purpose vehicles that conform to the definition of PRIIPs should also fall within the scope of this Regulation. For all those products, investments are not of the direct kind that is achieved when buying or holding assets themselves. Instead these products intercede between the retail investor and the markets through a process of packaging or wrapping together assets so as to create different exposures, provide different product features, or achieve different cost structures as compared with a direct holding. Such packaging can allow retail investors to engage in investment strategies that would otherwise be inaccessible or impractical, but can also require additional information to be made available, in particular to enable comparisons between different ways of packaging investments. (7) In order to ensure that this Regulation applies solely to such PRIIPs, insurance products that do not offer investment opportunities and deposits solely exposed to interest rates should be excluded from the scope of this Regulation. In the case of life insurance products, the term \u2018capital\u2019 means capital that is invested on the request of the retail investor. In addition, any deposit or certificates which represent traditional deposits, other than structured deposits as defined in point (43) of Article 4(1) of Directive 2014/65/EU should be excluded from the scope of this Regulation. Assets that are held directly, such as corporate shares or sovereign bonds, are not PRIIPs, and should therefore be excluded from the scope of this Regulation. Investment funds dedicated to institutional investors are excluded from the scope of this Regulation since they are not for sale to retail investors. Individual and occupational pension products, recognised under national law as having the primary purpose of providing the investor with an income in retirement, should be excluded from the scope of this Regulation, in consideration of their peculiarities and objectives, whereas other individual insurance accumulation or saving products that offer investment opportunities should be covered by this Regulation. (8) This Regulation does not prejudice the right of Member States to regulate the provision of key information on products that fall outside its scope. In accordance with their mandate for consumer protection under Article 9 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (6), of Regulation (EU) No 1094/2010 of the European Parliament and of the Council (7) and of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (8), the European Supervisory Authority (European Banking Authority) ('EBA'), the European Supervisory Authority (European Insurance and Occupational Pensions Authority) ('EIOPA') and the European Supervisory Authority (European Securities and Markets Authority) ('ESMA') established by those Regulations (the 'ESAs') should monitor the products which are excluded from the scope of this Regulation and, where appropriate, should issue guidelines to address any problem which is identified. Such guidelines should be taken into account in the review, to be conducted four years after the entry into force of this Regulation, on the possible extension of the scope and the elimination of certain exclusions. (9) To provide clarity on the relationship between the obligations established by this Regulation and obligations established by other legislative acts requiring the provision of information to investors, including but not limited to Directive 2003/71/EC of the European Parliament and of the Council (9) and Directive 2009/138/EC of the European Parliament and of the Council (10), it is necessary to establish that those legislative acts continue to apply in addition to this Regulation. (10) To ensure orderly and effective supervision of compliance with the requirements of this Regulation, Member States should designate the competent authorities responsible for that supervision. In many cases, competent authorities are already designated to supervise other obligations of PRIIP manufacturers, sellers or advisors, arising from other provisions of national and Union law. (11) The competent authorities should be provided, upon request and including ex ante, with all necessary information to verify the contents of the key information documents, to assess compliance with this Regulation and to ensure the protection of clients and investors in financial markets. (12) PRIIP manufacturers \u2014 such as fund managers, insurance undertakings, credit institutions or investment firms \u2014 should draw up the key information document for the PRIIPs that they manufacture, as they are in the best position to know the product. They should also be responsible for the accuracy of the key information document. The key information document should be drawn up by the PRIIP manufacturer before the product can be sold to retail investors. However, where a product is not sold to retail investors, there should be no obligation to draw up a key information document, and where it is impractical for the PRIIP manufacturer to draw up the key information document, it should remain possible for this task to be delegated to others. The obligations under this Regulation which are laid down in the provisions on drawing up, and the rules on revision of, the key information document should apply only to the PRIIP manufacturer and should continue to apply for as long as the PRIIP is traded on secondary markets. In order to ensure widespread dissemination and availability of key information documents, this Regulation should provide for publication by the PRIIP manufacturer of key information documents on its website. (13) To meet the needs of retail investors, it is necessary to ensure that information on PRIIPs is accurate, fair, clear and not misleading for those retail investors. This Regulation should therefore lay down common standards for the drafting of the key information document, in order to ensure that it is comprehensible to retail investors. Given the difficulties many retail investors have in understanding specialist financial terminology, particular attention should be paid to the vocabulary and style of writing used in the document. Rules should also be laid down on the language in which the key information document should be drawn up. Furthermore, retail investors should be able to understand the key information document on its own without referring to other non-marketing information. (14) When developing the technical standards for the content of the key information document so as to reflect accurately the product's investment policies and its objectives in accordance with this Regulation, the ESAs should ensure that the PRIIP manufacturer uses clear and understandable language which is accessible to retail investors and that the description of how the investment targets are achieved, including the description of the financial instruments used, avoids financial jargon and terminology which is not immediately clear to retail investors. (15) Retail investors should be provided with the information necessary for them to make an informed investment decision and compare different PRIIPs, but unless the information is short and concise there is a risk that they will not use it. The key information document should therefore only contain key information, in particular as regards the nature and features of the product, including whether it is possible to lose capital, the costs and risk profile of the product, as well as relevant performance information, and certain other specific information which may be necessary for understanding the features of individual types of product. (16) Investment product calculators are already being developed at national level. However, in order that the calculators are as useful as possible to consumers, they should cover the costs and fees charged by the various PRIIP manufacturers, together with any further costs or fees charged by intermediaries or other parts of the investment chain not already included by the PRIIP manufacturers. The Commission should report on whether those tools are available on-line in each Member State and whether they provide for reliable and accurate computations of aggregate costs and fees for all products within the scope of this Regulation. (17) The key information document should be drawn up in a standardised format which allows retail investors to compare different PRIIPs, since consumer behaviour and capabilities are such that the format, presentation and content of information must be carefully calibrated to maximise understanding and use of information. The same order of items and headings for these items should be followed for each document. In addition, the details of the information to be included in the key information document for different PRIIPs and the presentation of this information should be further harmonised through regulatory technical standards that take into account existing and ongoing research into consumer behaviour, including results from testing the effectiveness of different ways of presenting information with consumers. In addition, some PRIIPs give the retail investor a choice between multiple underlying investments, such as internal funds held by insurance undertakings. Those products should be taken into account when drawing up the format. (18) As some of the investment products within the scope of this Regulation are not simple and may be difficult for retail investors to understand, the key information document should, where applicable, include a comprehension alert to the retail investor. A product should be regarded as not being simple and as being difficult to understand in particular if it invests in underlying assets in which retail investors do not commonly invest, if it uses a number of different mechanisms to calculate the final return of the investment, creating a greater risk of misunderstanding on the part of the retail investor or if the investment's pay-off takes advantage of retail investor's behavioural biases, such as a teaser rate followed by a much higher floating conditional rate, or an iterative formula. (19) Increasingly, retail investors pursue, along with the financial returns on their investment, additional purposes such as social or environmental goals. However, information on social or environmental outcomes sought by the PRIIP manufacturer can be difficult to compare or may be absent. Therefore, anticipated sustainable environmental and social developments in financial investments, as well as the application of Regulation (EU) No 346/2013 of the European Parliament and of the Council (11) could allow for such aspects to be more appropriately integrated into, and further fostered by, Union law. However there are no established criteria and there is no formal procedure to verify such social or environmental criteria objectively, as there already are in the food sector. Therefore, it is desirable that in its review of this Regulation the Commission thoroughly considers developments relating to social and environmental investment products and the outcome of the review of Regulation (EU) No 346/2013. (20) The key information document should be clearly distinguishable and separate from any marketing communications. (21) To ensure that the information in the key information document is reliable, PRIIP manufacturers should be required to keep the key information document up to date. To that end, it is necessary to establish detailed rules relating to the conditions and frequency of the review of the information and the revision of the key information document in regulatory technical standards to be adopted by the Commission. (22) Key information documents are the foundation for investment decisions by retail investors. For that reason, PRIIP manufacturers have a significant responsibility towards retail investors in ensuring that they are not misleading, inaccurate or inconsistent with the relevant parts of the contractual documents of the PRIIP. It is therefore important to ensure that retail investors have an effective right of redress. It should also be ensured that all retail investors across the Union have the same right to seek compensation for damage suffered due to failure to comply with this Regulation. Therefore, rules regarding the civil liability of the PRIIP manufacturers should be harmonised. Retail investors should be able to hold the PRIIP manufacturer liable for an infringement of this Regulation where damage is suffered as a result of reliance on a key information document that is inconsistent with pre-contractual or contractual documents under the PRIIP manufacturer's control, or is misleading or inaccurate. (23) Matters concerning the civil liability of a PRIIP manufacturer which are not covered by this Regulation should be governed by the applicable national law. The court competent to decide on a claim for civil liability brought by a retail investor should be determined by the relevant rules on international jurisdiction. (24) This Regulation does not introduce a passport allowing for the cross-border sale or marketing of PRIIPs to retail investors, or alter existing passport arrangements for the cross-border sale or marketing of PRIIPs, if any. This Regulation does not alter the allocation of responsibilities between existing competent authorities under existing passport arrangements. Competent authorities designated by Member States for the purposes of this Regulation should therefore be consistent with those competent for the marketing of PRIIPs under an existing passport, if any. The competent authority of the Member State where the PRIIP is marketed should be responsible for supervision of the marketing of that PRIIP. The competent authority of the Member State where the product is marketed should always have the right to suspend the marketing of a PRIIP within their territory in cases of non-compliance with this Regulation. (25) The powers of EIOPA and the relevant competent authorities should be complemented by an explicit mechanism for prohibiting or restricting the marketing, distribution and sale of insurance-based investment products giving rise to serious concerns regarding investor protection, orderly functioning and integrity of financial markets, or the stability of the whole or part of the financial system, together with appropriate coordination and contingency powers for EIOPA. Those powers should also reflect the powers conferred on ESMA and EBA under Regulation (EU) No 600/2014 of the European Parliament and of the Council (12) so as to ensure that such mechanisms for intervention can be applied for all investment products irrespective of their legal form. The exercise of such powers by competent authorities and, in exceptional cases, by EIOPA should be subject to the need to fulfil a number of specific conditions. Where those conditions are met, the competent authority or, in exceptional cases, EIOPA should be able to impose a prohibition or restriction on a precautionary basis before an insurance-based investment product has been marketed, distributed or sold to investors. Those powers do not imply any requirement to introduce or apply product approval or licensing by the competent authority or by EIOPA, and do not relieve the manufacturer of an insurance-based investment product of its responsibility to comply with all the relevant requirements of this Regulation. Moreover, those powers should be used exclusively in the public interest and should not give rise to civil liability on the part of the competent authorities. (26) In order for the retail investor to be able to make an informed investment decision, persons advising on or selling PRIIPs should be required to provide the key information document in good time before any transaction is concluded. This requirement should apply irrespective of where or how the transaction takes place. However, where the transaction is by means of distance communication, the key information document may be provided immediately after the transaction is concluded as long as it is not possible to provide the key information document in advance and the retail investor consents. Persons advising on, or selling, PRIIPs include intermediaries and the PRIIP manufacturers themselves where the PRIIP manufacturers choose to advise on, or sell, the PRIIP directly to retail investors. This Regulation is without prejudice to Directive 2000/31/EC of the European Parliament and of the Council (13) and to Directive 2002/65/EC of the European Parliament and of the Council (14). (27) Uniform rules should be laid down in order to give the person advising on, or selling, the PRIIP a certain choice with regard to the medium in which the key information document is provided to retail investors, allowing for use of electronic communications where appropriate having regard to the circumstances of the transaction. However, the retail investor should be given the option to receive it on paper. In the interest of consumer access to information, the key information document should always be provided free of charge. (28) To ensure the trust of retail investors in PRIIPs and in financial markets as a whole, requirements should be established for appropriate internal procedures which ensure that retail investors receive a substantive response from the PRIIP manufacturer to complaints. (29) As the key information documents for PRIIPs should be produced by entities operating in the banking, insurance, securities and fund sectors of the financial markets, it is of utmost importance to ensure smooth cooperation between the various authorities supervising PRIIP manufacturers and persons advising on, or selling, PRIIPs so that they have a common approach to the application of this Regulation. (30) In line with the Commission Communication of 8 December 2010 entitled 'Reinforcing sanctioning regimes in the financial services sector' and in order to ensure that the requirements of this Regulation are fulfilled, it is important that Member States take necessary steps to ensure that infringements of this Regulation are subject to appropriate administrative penalties and measures. In order to ensure that penalties have a dissuasive effect and to strengthen investor protection by warning them about PRIIPs marketed in infringement of this Regulation, sanctions and measures should normally be published, except in certain well-defined circumstances. (31) Although Member States may lay down rules for administrative and criminal penalties for the same infringements, Member States should not be required to lay down rules for administrative penalties for the infringements of this Regulation which are subject to national criminal law. In accordance with national law, Member States are not obliged to impose both administrative and criminal penalties for the same offence, but they should be able to do so if their national law so permits. However, the maintenance of criminal penalties instead of administrative penalties for infringements of this Regulation should not reduce or otherwise affect the ability of competent authorities to cooperate, access and exchange information in a timely way with competent authorities in other Member States for the purposes of this Regulation, including after any referral of the relevant infringements to the competent judicial authorities for criminal prosecution. (32) In order to fulfil the objectives of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of specifying the details of the procedures used to establish whether a PRIIP targets specific environmental or social objectives, and the conditions for the exercise of intervention powers by EIOPA and the competent authorities. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (33) The Commission should adopt draft regulatory technical standards developed by the ESAs, through the Joint Committee, with regard to the presentation and the content of the key information document, the standardised format of the key information document, the methodology underpinning the presentation of risk and reward and the calculation of costs, as well as the conditions and the minimum frequency for reviewing the information contained in the key information document and the conditions fulfilling the requirement on the provision of the key information document to retail investors in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010. The Commission should complement the technical work of the ESAs by conducting consumer tests of the presentation of the key information document as proposed by the ESAs. (34) Directive 95/46/EC of the European Parliament and of the Council (15) governs the processing of personal data carried out in the Member States in the context of this Regulation and under the supervision of the competent authorities. Regulation (EC) No 45/2001 of the European Parliament and of the Council (16), governs the processing of personal data carried out by the ESAs pursuant to this Regulation and under the supervision of the European Data Protection Supervisor. Any processing of personal data carried out within the framework of this Regulation, such as the exchange or transmission of personal data by the competent authorities should be undertaken in accordance with Directive 95/46/EC and any exchange or transmission of information by the ESAs should be undertaken in accordance with Regulation (EC) No 45/2001. (35) While undertakings for collective investment in transferable securities (UCITS) constitute investment products within the meaning of this Regulation, the recent establishment of the key investor information requirements under Directive 2009/65/EC means that it would be proportionate to provide to such UCITS a transitional period of five years after the entry into force of this Regulation during which they would not be subject to this Regulation. After the expiry of that transitional period and in the absence of any extension thereto, UCITS should become subject to this Regulation. That transitional period should also apply to management companies, investment companies and persons advising on, or selling, units of non-UCITS funds when a Member State applies rules on the format and content of the key information document, as laid down in Articles 78 to 81 of Directive 2009/65/EC, to such funds. (36) A review of this Regulation should be carried out four years after its entry into force in order to take account of market developments, such as the emergence of new types of PRIIPs, as well as developments in other areas of Union law and the experiences of Member States. The review should also assess the feasibility, costs and possible benefits of introducing a label for social and environmental investments. Furthermore, the review should assess whether the measures introduced have improved the average retail investor understanding of PRIIPs and the comparability of the PRIIPs. It should also consider whether the transitional period applying to UCITS or certain non-UCITS should be extended, or whether other options for the treatment of such funds might be considered. In addition, it should assess whether the exemption of products from the scope of this Regulation should be maintained, in view of the need for sound standards of consumer protection including comparisons between financial products. As part of the review, the Commission should also carry out a market survey to determine whether there are online calculator tools available in the market which allow the retail investor to compute the aggregate costs and fees of PRIIPs and whether those tools are made available free of charge. On the basis of that review, the Commission should submit a report to the European Parliament and to the Council accompanied, if appropriate, by legislative proposals. (37) Having regard to the ongoing work undertaken by EIOPA on disclosure of product information requirements for personal pension products and taking into account the specificities of those products, the Commission should, within four years after the entry into force of this Regulation, assess whether to maintain the exclusion of pension products which, under national law, are recognised as having the primary purpose of providing the investor with an income in retirement, and which entitle the investor to certain benefits. In making its assessment, the Commission should consider whether this Regulation is the best legislative mechanism for ensuring the disclosure relating to pension products, or whether other disclosure mechanisms would be more appropriate. (38) In order to give PRIIP manufacturers and persons advising on, or selling, PRIIPs sufficient time to prepare for the practical application of the requirements of this Regulation, it should not be applicable until two years after the date of its entry into force. (39) This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of the Fundamental Rights of the European Union. (40) Since the objectives of this Regulation, namely to enhance retail investor protection and improve retail investor confidence in PRIIPs, including where those products are sold cross-border, cannot be sufficiently achieved by the Member States but can rather, by reason of its effects, be better achieved at Union level the Union may adopt measures, in accordance with principle of subsidiarity as set out in Article 5 of the Treaty of the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (41) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered its opinion (17), HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 This Regulation lays down uniform rules on the format and content of the key information document to be drawn up by PRIIP manufacturers and on the provision of the key information document to retail investors in order to enable retail investors to understand and compare the key features and risks of the PRIIP. Article 2 1. This Regulation shall apply to PRIIP manufacturers and persons advising on, or selling, PRIIPs. 2. This Regulation shall not apply to the following products: (a) non-life insurance products as listed in Annex I to Directive 2009/138/EC; (b) life insurance contracts where the benefits under the contract are payable only on death or in respect of incapacity due to injury, sickness or infirmity; (c) deposits other than structured deposits as defined in point (43) of Article 4(1) of Directive 2014/65/EU; (d) securities as referred to in points (b) to (g), (i) and (j) of Article 1(2) of Directive 2003/71/EC; (e) pension products which, under national law, are recognised as having the primary purpose of providing the investor with an income in retirement and which entitle the investor to certain benefits; (f) officially recognised occupational pension schemes within the scope of Directive 2003/41/EC of the European Parliament and of the Council (18) or Directive 2009/138/EC; (g) individual pension products for which a financial contribution from the employer is required by national law and where the employer or the employee has no choice as to the pension product or provider. Article 3 1. Where PRIIP manufacturers subject to this Regulation are also subject to Directive 2003/71/EC, this Regulation and Directive 2003/71/EC shall both apply. 2. Where PRIIP manufacturers subject to this Regulation are also subject to Directive 2009/138/EC, this Regulation and Directive 2009/138/EC shall both apply. Article 4 For the purposes of this Regulation, the following definitions apply: (1) \u2018packaged retail investment product\u2019 or \u2018PRIP\u2019 means an investment, including instruments issued by special purpose vehicles as defined in point (26) of Article 13 of Directive 2009/138/EC or securitisation special purpose entities as defined in point (an) of Article 4(1) of the Directive 2011/61/EU of the European Parliament and of the Council (19), where, regardless of the legal form of the investment, the amount repayable to the retail investor is subject to fluctuations because of exposure to reference values or to the performance of one or more assets which are not directly purchased by the retail investor; (2) \u2018insurance-based investment product\u2019 means an insurance product which offers a maturity or surrender value and where that maturity or surrender value is wholly or partially exposed, directly or indirectly, to market fluctuations; (3) \u2018packaged retail and insurance-based investment product\u2019 or \u2018PRIIP\u2019 means a product that is one or both of the following: (a) a PRIP; (b) an insurance-based investment product; (4) \u2018packaged retail and insurance-based investment product manufacturer\u2019 or \u2018PRIIP manufacturer\u2019 means: (a) any entity that manufactures PRIIPs; (b) any entity that makes changes to an existing PRIIP including, but not limited to, altering its risk and reward profile or the costs associated with an investment in a PRIIP; (5) \u2018person selling a PRIIP\u2019 means a person offering or concluding a PRIIP contract with a retail investor; (6) \u2018retail investor\u2019 means: (a) a retail client as defined in point (11) of Article 4 (1) of Directive 2014/65/EU; (b) a customer within the meaning of Directive 2002/92/EC, where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of Directive 2014/65/EU; (7) \u2018durable medium\u2019 means a durable medium as defined in point (m) of Article 2(1) of Directive 2009/65/EC; (8) \u2018competent authorities\u2019 means the national authorities designated by a Member State to supervise the requirements this Regulation places on PRIIP manufacturers and the persons advising on, or selling, the PRIIP. CHAPTER II KEY INFORMATION DOCUMENT SECTION I Drawing up the key information document Article 5 1. Before a PRIIP is made available to retail investors, the PRIIP manufacturer shall draw up for that product a key information document in accordance with the requirements of this Regulation and shall publish the document on its website. 2. Any Member State may require the ex ante notification of the key information document by the PRIIP manufacturer or the person selling a PRIIP to the competent authority for PRIIPs marketed in that Member State. SECTION II Form and content of the key information document Article 6 1. The key information document shall constitute pre-contractual information. It shall be accurate, fair, clear and not misleading. It shall provide key information and shall be consistent with any binding contractual documents, with the relevant parts of the offer documents and with the terms and conditions of the PRIIP. 2. The key information document shall be a stand-alone document, clearly separate from marketing materials. It shall not contain cross-references to marketing material. It may contain cross-references to other documents including a prospectus where applicable, and only where the cross-reference is related to the information required to be included in the key information document by this Regulation. 3. By way of derogation from paragraph 2, where a PRIIP offers the retail investor a range of options for investments, such that all information required in Article 8(3) with regard to each underlying investment option cannot be provided within a single, concise stand-alone document, the key information document shall provide at least a generic description of the underlying investment options and state where and how more detailed pre-contractual information documentation relating to the investment products backing the underlying investment options can be found. 4. The key information document shall be drawn up as a short document written in a concise manner and of a maximum of three sides of A4-sized paper when printed, which promotes comparability. It shall: (a) be presented and laid out in a way that is easy to read, using characters of readable size; (b) focus on the key information that retail investors need; (c) be clearly expressed and written in language and a style that communicate in a way that facilitates the understanding of the information, in particular, in language that is clear, succinct and comprehensible. 5. Where colours are used in the key information document, they shall not diminish the comprehensibility of the information if the key information document is printed or photocopied in black and white. 6. Where the corporate branding or logo of the PRIIP manufacturer or the group to which it belongs is used in the key information document, it shall not distract the retail investor from the information contained in the document or obscure the text. Article 7 1. The key information document shall be written in the official languages, or in one of the official languages, used in the part of the Member State where the PRIIP is distributed, or in another language accepted by the competent authorities of that Member State, or where it has been written in a different language, it shall be translated into one of these languages. The translation shall faithfully and accurately reflect the content of the original key information document. 2. If a PRIIP is promoted in a Member State through marketing documents written in one or more official languages of that Member State, the key information document shall at least be written in the corresponding official languages. Article 8 1. The title 'Key Information Document' shall appear prominently at the top of the first page of the key information document. The key information document shall be presented in the sequence laid down in paragraphs 2 and 3. 2. An explanatory statement shall appear directly underneath the title of the key information document. It shall read: \u2018This document provides you with key information about this investment product. It is not marketing material. The information is required by law to help you understand the nature, risks, costs, potential gains and losses of this product and to help you compare it with other products.\u2019. 3. The key information document shall contain the following information: (a) at the beginning of the document, the name of the PRIIP, the identity and contact details of the PRIIP manufacturer, information about the competent authority of the PRIIP manufacturer and the date of the document; (b) where applicable, a comprehension alert which shall read: \u2018You are about to purchase a product that is not simple and may be difficult to understand.\u2019; (c) under a section titled \u2018What is this product?\u2019, the nature and main features of the PRIIP, including: (i) the type of the PRIIP; (ii) its objectives and the means for achieving them, in particular whether the objectives are achieved by means of direct or indirect exposure to the underlying investment assets, including a description of the underlying instruments or reference values, including a specification of the markets the PRIIP invests in, including, where applicable, specific environmental or social objectives targeted by the product, as well as how the return is determined; (iii) a description of the type of retail investor to whom the PRIIP is intended to be marketed, in particular in terms of the ability to bear investment loss and the investment horizon; (iv) where the PRIIP offers insurance benefits, details of those insurance benefits, including the circumstances that would trigger them; (v) the term of the PRIIP, if known; (d) under a section titled \u2018What are the risks and what could I get in return?\u2019, a brief description of the risk-reward profile comprising the following elements: (i) a summary risk indicator, supplemented by a narrative explanation of that indicator, its main limitations and a narrative explanation of the risks which are materially relevant to the PRIIP and which are not adequately captured by the summary risk indicator; (ii) the possible maximum loss of invested capital, including, information on: \u2014 whether the retail investor can lose all invested capital, or \u2014 whether the retail investor bears the risk of incurring additional financial commitments or obligations, including contingent liabilities in addition to the capital invested in the PRIIP, and \u2014 where applicable, whether the PRIIP includes capital protection against market risk, and the details of its cover and limitations, in particular with respect to the timing of when it applies; (iii) appropriate performance scenarios, and the assumptions made to produce them; (iv) where applicable, information on conditions for returns to retail investors or built-in performance caps; (v) a statement that the tax legislation of the retail investor's home Member State may have an impact on the actual payout; (e) under a section titled \u2018What happens if [the name of the PRIIP manufacturer] is unable to pay out?\u2019, a brief description of whether the related loss is covered by an investor compensation or guarantee scheme and if so, which scheme it is, the name of the guarantor and which risks are covered by the scheme and which are not; (f) under a section titled \u2018What are the costs?\u2019, the costs associated with an investment in the PRIIP, comprising both direct and indirect costs to be borne by the retail investor, including one-off and recurring costs, presented by means of summary indicators of these costs and, to ensure comparability, total aggregate costs expressed in monetary and percentage terms, to show the compound effects of the total costs on the investment. The key information document shall include a clear indication that advisors, distributors or any other person advising on, or selling, the PRIIP will provide information detailing any cost of distribution that is not already included in the costs specified above, so as to enable the retail investor to understand the cumulative effect that these aggregate costs have on the return of the investment; (g) under a section titled \u2018How long should I hold it and can I take money out early?\u2019 (i) where applicable, whether there is a cooling off period or cancellation period for the PRIIP; (ii) an indication of the recommended and, where applicable, required minimum holding period; (iii) the ability to make, and the conditions for, any disinvestments before maturity, including all applicable fees and penalties, having regard to the risk and reward profile of the PRIIP and the market evolution it targets; (iv) information about the potential consequences of cashing in before the end of the term or recommended holding period, such as the loss of capital protection or additional contingent fees; (h) under a section titled \u2018How can I complain?\u2019, information about how and to whom a retail investor can make a complaint about the product or the conduct of the PRIIP manufacturer or a person advising on, or selling, the product; (i) under a section titled \u2018Other relevant information\u2019, a brief indication of any additional information documents to be provided to the retail investor at the pre-contractual and/or the post-contractual stage, excluding any marketing material. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 30 specifying the details of the procedures used to establish whether a PRIIP targets specific environmental or social objectives. 5. In order to ensure consistent application of this Article, the ESAs shall, through the Joint Committee of the European Supervisory Authorities (\u2018Joint Committee\u2019), develop draft regulatory technical standards specifying: (a) the details of the presentation and the content of each of the elements of information referred to in paragraph 3; (b) the methodology underpinning the presentation of risk and reward as referred to in points (d) (i) and (iii) of paragraph 3; and (c) the methodology for the calculation of costs, including the specification of summary indicators, as referred to in point (f) of paragraph 3. When developing the draft regulatory technical standards the ESAs shall take into account the various types of PRIIPs, the differences between them and the capabilities of retail investors as well as the features of the PRIIPs so as to allow the retail investor to select between different underlying investments or other options provided for by the product, including where this selection can be undertaken at different points in time, or changed in the future. The ESAs shall submit those draft regulatory technical standards to the Commission by 31 March 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010. Article 9 Marketing communications that contain specific information relating to the PRIIP shall not include any statement that contradicts the information contained in the key information document or diminishes the significance of the key information document. Marketing communications shall indicate that a key information document is available and supply information on how and from where to obtain it, including the PRIIP manufacturer's website. Article 10 1. The PRIIP manufacturer shall review the information contained in the key information document regularly and shall revise the document where the review indicates that changes need to be made. The revised version shall be made available promptly. 2. In order to ensure consistent application of this Article, the ESAs shall, through the Joint Committee, develop draft regulatory technical standards specifying: (a) the conditions for reviewing the information contained in the key information document; (b) the conditions under which the key information document must be revised; (c) the specific conditions under which information contained in the key information document must be reviewed or the key information document revised where a PRIIP is made available to retail investors in a non-continuous manner; (d) the circumstances in which retail investors are to be informed about a revised key information document for a PRIIP purchased by them, as well as the means by which the retail investors are to be informed. The ESAs shall submit those draft regulatory technical standards to the Commission by 31 December 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010. Article 11 1. The PRIIP manufacturer shall not incur civil liability solely on the basis of the key information document, including any translation thereof, unless it is misleading, inaccurate or inconsistent with the relevant parts of legally binding pre-contractual and contractual documents or with the requirements laid down in Article 8. 2. A retail investor who demonstrates loss resulting from reliance on a key information document under the circumstances referred to in paragraph 1, when making an investment into the PRIIP for which that key information document was produced, may claim damages from the PRIIP manufacturer for that loss in accordance with national law. 3. Elements such as \u2018loss\u2019 or \u2018damages\u2019 as referred to in paragraph 2 of this Article which are not defined shall be interpreted and applied in accordance with the applicable national law as determined by the relevant rules of private international law. 4. This Article does not exclude further civil liability claims in accordance with national law. 5. The obligations under this Article shall not be limited or waived by contractual clauses. Article 12 Where the key information document concerns an insurance contract, the insurance undertakings' obligations under this Regulation are only towards the policyholder of the insurance contract and not towards the beneficiary of the insurance contract. SECTION III Provision of the key information document Article 13 1. A person advising on, or selling, a PRIIP shall provide retail investors with the key information document in good time before those retail investors are bound by any contract or offer relating to that PRIIP. 2. A person advising on, or selling, a PRIIP may satisfy the requirements of paragraph 1 by providing the key information document to a person with written authority to make investment decisions on behalf of the retail investor in respect of transactions concluded under that written authority. 3. By way of derogation from paragraph 1 and subject to Article 3(1), point (a) of Article 3(3) and Article 6 of Directive 2002/65/EC, a person selling a PRIIP may provide the retail investor with the key information document after conclusion of the transaction, without undue delay, where all of the following conditions are met: (a) the retail investor chooses, on his own initiative, to contact the person selling a PRIIP and conclude the transaction using a means of distance communication; (b) provision of the key information document in accordance with paragraph 1 of this Article is not possible; (c) the person advising on or selling the PRIIP has informed the retail investor that provision of the key information document is not possible and has clearly stated that the retail investor may delay the transaction in order to receive and read the key information document before concluding the transaction; (d) the retail investor consents to receiving the key information document without undue delay after conclusion of the transaction, rather than delaying the transaction in order to receive the document in advance. 4. Where successive transactions regarding the same PRIIP are carried out on behalf of a retail investor in accordance with instructions given by that retail investor to the person selling the PRIIP prior to the first transaction, the obligation to provide a key information document under paragraph 1 shall apply only to the first transaction, and to the first transaction after the key information document has been revised in accordance with Article 10. 5. In order to ensure consistent application of this Article, the ESAs shall, through the Joint Committee, develop draft regulatory technical standards specifying the conditions for fulfilling the requirement to provide the key information document as laid down in paragraph 1. The ESAs shall submit those draft regulatory technical standards to the Commission by 31 December 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010. Article 14 1. The person advising on, or selling, a PRIIP shall provide the key information document to retail investors free of charge. 2. The person advising on, or selling, a PRIIP shall provide the key information document to the retail investor in one of the following media: (a) on paper, which should be the default option where the PRIIP is offered on a face-to-face basis, unless the retail investor requests otherwise; (b) using a durable medium other than paper, where the conditions laid down in paragraph 4 are met; or (c) by means of a website where the conditions laid down in paragraph 5 are met. 3. Where the key information document is provided using a durable medium other than paper or by means of a website, a paper copy shall be provided to retail investors upon request and free of charge. Retail investors shall be informed about their right to request a paper copy free of charge. 4. The key information document may be provided using a durable medium other than paper if the following conditions are met: (a) the use of the durable medium is appropriate in the context of the business conducted between the person advising on, or selling, a PRIIP and the retail investor; and (b) the retail investor has been given the choice between information on paper and in the durable medium, and has chosen that other medium in a way that can be evidenced. 5. The key information document may be provided by the means of a website that does not meet the definition of a durable medium if all of the following conditions are met: (a) the provision of the key information document by means of a website is appropriate in the context of the business conducted between the person advising on, or selling, a PRIIP and the retail investor; (b) the retail investor has been given the choice between information provided on paper and by means of a website and has chosen the latter in a way that can be evidenced; (c) the retail investor has been notified electronically, or in written form, of the address of the website, and the place on the website where the key information document can be accessed; (d) the key information document remains accessible on the website, capable of being downloaded and stored in a durable medium, for such period of time as the retail investor may need to consult it. Where the key information document has been revised in accordance with Article 10, previous versions shall also be provided on request of the retail investor. 6. For the purposes of paragraphs 4 and 5, the provision of information using a durable medium other than paper or by means of a website shall be regarded as appropriate in the context of the business conducted between the person advising on or selling a PRIIP and the retail investor if there is evidence that the retail investor has regular access to the internet. The provision by the retail investor of an email address for the purposes of that business shall be regarded as such evidence. CHAPTER III MARKET MONITORING AND PRODUCT INTERVENTION POWERS Article 15 1. In accordance with Article 9(2) of Regulation (EU) No 1094/2010, EIOPA shall monitor the market for insurance-based investment products which are marketed, distributed or sold in the Union. 2. Competent authorities shall monitor the market for insurance-based investment products which are marketed, distributed or sold in or from their Member State. Article 16 1. In accordance with Article 9(5) of Regulation (EU) No 1094/2010, EIOPA may, where the conditions in paragraphs 2 and 3 of this Article are fulfilled, temporarily prohibit or restrict in the Union: (a) the marketing, distribution or sale of certain insurance-based investment products or insurance-based investment products with certain specified features; or (b) a type of financial activity or practice of an insurance or reinsurance undertaking. A prohibition or restriction may apply in circumstances, or be subject to exceptions, specified by EIOPA. 2. EIOPA shall take a decision under paragraph 1 only if all of the following conditions are fulfilled: (a) the proposed action addresses a significant investor protection concern or a threat to the orderly functioning and integrity of financial markets or to the stability of the whole or part of the financial system in the Union; (b) regulatory requirements under Union law that are applicable to the relevant insurance-based investment product or activity do not address the threat; (c) a competent authority or competent authorities have not taken action to address the threat or the actions that have been taken do not adequately address the threat. Where the conditions set out in the first subparagraph are fulfilled, EIOPA may impose the prohibition or restriction referred to in paragraph 1 on a precautionary basis before an insurance-based investment product has been marketed or sold to investors. 3. When taking action under this Article, EIOPA shall ensure that the action does not: (a) have a detrimental effect on the efficiency of financial markets or on investors that is disproportionate to the benefits of the action; or (b) create a risk of regulatory arbitrage. Where a competent authority or competent authorities have taken a measure under Article 17, EIOPA may take any of the measures referred to in paragraph 1 of this Article without issuing the opinion provided for in Article 18. 4. Before deciding to take any action under this Article, EIOPA shall notify competent authorities of the action it proposes. 5. EIOPA shall publish on its website notice of any decision to take any action under this Article. The notice shall specify details of the prohibition or restriction and specify a time after the publication of the notice from which the measures will take effect. A prohibition or restriction shall only apply to action taken after the measures take effect. 6. EIOPA shall review a prohibition or restriction imposed under paragraph 1 at appropriate intervals and at least every three months. If the prohibition or restriction is not renewed after that three-month period it shall expire. 7. Action adopted by EIOPA under this Article shall prevail over any previous action taken by a competent authority. 8. The Commission shall adopt delegated acts in accordance with Article 30 specifying criteria and factors to be taken into account by EIOPA in determining when there is a significant investor protection concern or a threat to the orderly functioning and integrity of financial markets or to the stability of the whole or part of the financial system of the Union referred to in point (a) of the first subparagraph of paragraph 2. Those criteria and factors shall include: (a) the degree of complexity of the insurance-based investment product and the relation to the type of investor to whom it is marketed and sold; (b) the size or the notional value of the insurance-based investment product; (c) the degree of innovation of the insurance-based investment product, activity or a practice; and (d) the leverage a product or practice provides. Article 17 1. A competent authority may prohibit or restrict the following in or from its Member State: (a) the marketing, distribution or sale of insurance-based investment products or insurance-based investment products with certain specified features; or (b) a type of financial activity or practice of an insurance or reinsurance undertaking. 2. A competent authority may take the action referred to in paragraph 1 if it is satisfied on reasonable grounds that: (a) an insurance-based investment product, or activity or practice gives rise to significant investor protection concerns or poses a threat to the orderly functioning and integrity of financial markets or the stability of whole or part of the financial system within at least one Member State; (b) existing regulatory requirements under Union law applicable to the insurance-based investment product, or activity or practice do not sufficiently address the risks referred to in point (a) and the issue would not be better addressed by improved supervision or enforcement of existing requirements; (c) the action is proportionate taking into account the nature of the risks identified, the level of sophistication of investors or market participants concerned and the likely effect of the action on investors and market participants who may hold, use or benefit from the insurance-based investment product, or activity or practice; (d) the competent authority has properly consulted competent authorities in other Member States that may be significantly affected by the action; and (e) the action does not have a discriminatory effect on services or activities provided from another Member State. Where the conditions set out in the first subparagraph are fulfilled, the competent authority may impose the prohibition or restriction referred to in paragraph 1 on a precautionary basis before an insurance-based investment product has been marketed or sold to investors. A prohibition or restriction may apply in circumstances, or be subject to exceptions, specified by the competent authority. 3. The competent authority shall not impose a prohibition or restriction under this Article unless, not less than one month before the measure is intended to take effect, it has notified all other competent authorities involved and EIOPA in writing or through another medium agreed between the authorities of the details of: (a) the insurance-based investment product, or activity or practice to which the proposed action relates; (b) the precise nature of the proposed prohibition or restriction and when it is intended to take effect; and (c) the evidence upon which it has based its decision and upon which it is satisfied that each of the conditions in paragraph 2 are met. 4. In exceptional cases where the competent authority deems it necessary to take urgent action under this Article in order to prevent detriment arising from the insurance-based investment products, activities or practices referred to in paragraph 1, the competent authority may take action on a provisional basis with no less than 24 hours' written notice before the measure is intended to take effect to all other competent authorities and EIOPA, provided that all the criteria in this Article are met and that, in addition, it is clearly established that a one-month notification period would not adequately address the specific concern or threat. The competent authority shall not take action on a provisional basis for a period exceeding three months. 5. The competent authority shall publish on its website notice of any decision to impose any prohibition or restriction referred to in paragraph 1. That notice shall specify details of the prohibition or restriction, a time after the publication of the notice from which the measures will take effect and the evidence upon which it is satisfied each of the conditions in paragraph 2 are met. The prohibition or restriction shall only apply in relation to action taken after the publication of the notice. 6. The competent authority shall revoke a prohibition or restriction if the conditions in paragraph 2 no longer apply. 7. The Commission shall adopt delegated acts in accordance with Article 30 specifying criteria and factors to be taken into account by competent authorities in determining when there is a significant investor protection concern or a threat to the orderly functioning and integrity of financial markets or to the stability of the financial system within at least one Member State referred to in point (a) of the first subparagraph of paragraph 2. Those criteria and factors shall include: (a) the degree of complexity of an insurance-based investment product and the relation to the type of investor to whom it is marketed and sold; (b) the degree of innovation of an insurance-based investment product, an activity or a practice; (c) the leverage a product or practice provides; (d) in relation to the orderly functioning and integrity of financial markets, the size or the notional value of an insurance-based investment product. Article 18 1. EIOPA shall perform a facilitation and coordination role in relation to action taken by competent authorities under Article 17. In particular EIOPA shall ensure that action taken by a competent authority is justified and proportionate and that, where appropriate, a consistent approach is taken by competent authorities. 2. After receiving notification under Article 17 of any action that is to be imposed under that Article, EIOPA shall adopt an opinion on whether the prohibition or restriction is justified and proportionate. If EIOPA considers that the taking of a measure by other competent authorities is necessary to address the risk, it shall state this in its opinion. The opinion shall be published on EIOPA's website. 3. Where a competent authority proposes to take, or takes, action contrary to an opinion adopted by EIOPA under paragraph 2 or declines to take action contrary to such an opinion, it shall immediately publish on its website a notice fully explaining its reasons for so doing. CHAPTER IV COMPLAINTS, REDRESS, COOPERATION AND SUPERVISION Article 19 The PRIIP manufacturer and the person advising on, or selling, the PRIIP shall establish appropriate procedures and arrangements which ensure that: (a) retail investors have an effective way of submitting a complaint against the PRIIP manufacturer; (b) retail investors who have submitted a complaint in relation to the key information document receive a substantive reply in a timely and proper manner; and (c) effective redress procedures are also available to retail investors in the event of cross-border disputes, in particular where the PRIIP manufacturer is located in another Member State or in a third country. Article 20 1. For the purposes of the application of this Regulation the competent authorities shall cooperate with each other and, without undue delay, provide each other with such information as is relevant for the purposes of carrying out their duties under this Regulation and of making use of their powers. 2. Competent authorities shall, in accordance with national law, have all supervisory and investigatory powers that are necessary for the exercise of their functions under this Regulation. Article 21 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in that Member State pursuant to this Regulation. 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the ESAs. CHAPTER V ADMINISTRATIVE PENALTIES AND OTHER MEASURES Article 22 1. Without prejudice to the supervisory powers of competent authorities and the right of Member States to provide for and impose criminal sanctions, Member States shall lay down rules establishing appropriate administrative sanctions and measures applicable to situations which constitute an infringement of this Regulation and shall take all necessary measures to ensure that they are implemented. Those sanctions and measures shall be effective, proportionate and dissuasive. Member States may decide not to lay down rules for administrative sanctions as referred to in the first subparagraph for infringements which are subject to criminal sanctions under their national law. By 31 December 2016 the Member States shall notify the rules referred to in the first subparagraph to the Commission and to the Joint Committee. They shall notify the Commission and the Joint Committee without delay of any subsequent amendment thereto. 2. In the exercise of their powers in Article 24, competent authorities shall cooperate closely to ensure that the administrative sanctions and measures produce the results pursued by this Regulation and coordinate their action in order to avoid possible duplication and overlap when applying administrative sanctions and measures to cross-border cases. Article 23 Competent authorities shall exercise their powers to impose sanctions in accordance with this Regulation and national law in any of the following ways: (a) directly; (b) in collaboration with other authorities; (c) under their responsibility by delegation to such authorities; (d) by application to the competent judicial authorities. Article 24 1. This Article applies to infringements of Article 5(1), Articles 6 and 7, Article 8(1) to (3), Article 9, Article 10(1), Article 13(1), (3) and (4) and Articles 14 and 19. 2. The competent authorities shall have the power to impose, in accordance with national law, at least the following administrative sanctions and measures: (a) an order prohibiting the marketing of a PRIIP; (b) an order suspending the marketing of a PRIIP; (c) a public warning which indicates the person responsible for, and the nature of, the infringement; (d) an order prohibiting the provision of a key information document which does not comply with the requirement of Articles 6, 7, 8 or 10 and requiring the publication of a new version of a key information document; (e) administrative fines of at least: (i) in the case of a legal entity: \u2014 up to EUR 5 000 000, or, in the Member States whose currency is not the euro, the corresponding value in the national currency on 30 December 2014, or up to 3 % of the total annual turnover of that legal entity according to the last available financial statements approved by the management body, or \u2014 up to twice the amount of the profits gained or losses avoided because of the infringement where those can be determined; (ii) in the case of a natural person: \u2014 up to EUR 700 000, or, in the Member States whose currency is not the euro, the corresponding value in the national currency on 30 December 2014, or \u2014 up to twice the amount of the profits gained or losses avoided because of the infringement where those can be determined. Where the legal entity referred to in point (e)(i) of the first subparagraph is a parent undertaking or a subsidiary of a parent undertaking which is required to prepare consolidated financial statements according to Directive 2013/34/EU of the European Parliament and of the Council (20), the relevant total annual turnover shall be the total annual turnover or the corresponding type of income in accordance with the relevant Union law in the area of accounting according to the last available consolidated financial statements approved by the management body of the ultimate parent undertaking. 3. Member States may provide for additional sanctions or measures and for higher levels of administrative fines than those provided for in this Regulation. 4. Where the competent authorities have imposed one or more administrative penalties or measures in accordance with paragraph 2, the competent authorities shall have the power to issue or require the PRIIP manufacturer or person advising on, or selling, the PRIIP to issue a direct communication to the retail investor concerned, giving them information about the administrative sanction or measure, and informing them where to lodge complaints or submit claims for redress. Article 25 The competent authorities shall apply the administrative sanctions and measures referred to in Article 24(2) taking into account all relevant circumstances including, where appropriate: (a) the gravity and the duration of the infringement; (b) the degree of responsibility of the person responsible for the infringement; (c) the impact of the infringement on retail investors' interests; (d) the cooperative behaviour of the person responsible for the infringement; (e) any previous infringements by the person responsible for the infringement; (f) measures taken after the infringement by the person responsible for the infringement to prevent its repetition. Article 26 Decisions to impose sanctions and measures taken pursuant to this Regulation shall be subject to a right of appeal. Article 27 1. Where the competent authority has disclosed administrative sanctions or measures to the public, it shall simultaneously report those administrative sanctions or measures to the competent ESA. 2. The competent authority shall, on an annual basis, provide the competent ESA with aggregate information regarding all administrative sanctions and measures imposed in accordance with Article 22 and Article 24(2). 3. The ESAs shall publish the information referred to in this Article in their annual reports. Article 28 1. Competent authorities shall establish effective mechanisms to enable reporting of actual or potential infringements of this Regulation to them. 2. The mechanisms referred to in paragraph 1 shall include at least: (a) specific procedures for the receipt of reports of actual or potential infringements and their follow-up; (b) appropriate protection for employees who report infringements committed within their employer at least against retaliation, discrimination and other types of unfair treatment; (c) protection of the identity both of the person who reports the infringements and the natural person who is allegedly responsible for an infringement, at all stages of the procedure unless such disclosure is required by national law in the context of further investigation or subsequent judicial proceedings. 3. Member States may provide for competent authorities to establish additional mechanisms under national law. 4. Member States may require employers engaged in activities that are regulated for financial services purposes to have in place appropriate procedures for their employees to report actual or potential infringements internally through a specific, independent and autonomous channel. Article 29 1. A decision, against which there is no appeal, imposing an administrative sanction or measure for infringements referred to in Article 24(1) shall be published by competent authorities on their official website without undue delay after the person on whom the sanction or measure was imposed has been informed of that decision. The publication shall include at least the following information: (a) the type and nature of the infringement; (b) the identity of the persons responsible. That obligation does not apply to decisions imposing measures that are of an investigatory nature. Where the publication of the identity of the legal entities, or identity or personal data of natural persons, is considered by the competent authority to be disproportionate following a case-by-case assessment conducted on the proportionality of the publication of such data, or where such publication would jeopardise the stability of financial markets or an ongoing investigation, the competent authorities shall: (a) delay the publication of the decision to impose a sanction or a measure until the moment where the reasons for non-publication cease to exist; (b) publish the decision to impose a sanction or a measure on an anonymous basis in a manner which complies with national law, if such anonymous publication ensures an effective protection of the personal data concerned; or (c) not publish the decision to impose a sanction or measure in the event that the options laid down in points (a) and (b) are considered to be insufficient to ensure: (i) that the stability of financial markets would not be put in jeopardy; (ii) the proportionality of the publication of such decisions with regard to measures which are deemed to be of a minor nature. 2. Competent authorities shall inform the ESAs of all administrative sanctions or measures imposed but not published in accordance with point (c) of the third subparagraph of paragraph 1 including any appeal in relation thereto and the outcome thereof. In the case of a decision to publish a sanction or measure on an anonymous basis the publication of the relevant data may be postponed for a reasonable period of time if it is envisaged that within that period the reasons for anonymous publication will cease to exist. 3. Where national law provides for the publication of the decision to impose a sanction or measure which is subject to an appeal before the relevant judicial or other authorities, the competent authorities shall publish on their official website, without undue delay, such information and any subsequent information on the outcome of such appeal. Moreover, any decision annulling a previous decision to impose a sanction or a measure which has been published shall also be published. 4. Competent authorities shall ensure that any publication, in accordance with this Article, shall remain on their official website for a period of at least five years after its publication. Personal data contained in the publication shall be kept on the official website of the competent authority only for the period which is necessary in accordance with the applicable data protection rules. CHAPTER VI FINAL PROVISIONS Article 30 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 8(4), Article 16(8) and Article 17(7) shall be conferred on the Commission for a period of three years from 30 December 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the three-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 8(4), Article 16(8) and Article 17(7) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 8(4), Article 16(8) or Article 17(7) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 31 Where the Commission adopts regulatory technical standards pursuant to Article 8(5), Article 10(2) or Article 13(5) which are the same as the draft regulatory technical standards submitted by the ESAs, the period during which the European Parliament and the Council may object to those regulatory technical standards shall, by way of derogation from the second subparagraph of Article 13(1) of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010, and in order to take into account the complexity and volume of the issues covered therein, be two months from the date of notification. At the initiative of the European Parliament or the Council that period may be extended by one month. Article 32 1. Management companies as defined in Article 2(1)(b) of Directive 2009/65/EC, investment companies as referred to in Article 27 thereof and persons advising on, or selling, units of UCITS as referred to in Article 1(2) thereof shall be exempt from the obligations under this Regulation until 31 December 2019. 2. When a Member State applies rules on the format and content of the key information document, as laid down in Articles 78 to 81 of Directive 2009/65/EC, to non-UCITS funds offered to retail investors, the exemption laid down in paragraph 1 of this Article shall apply to management companies, investment companies and persons advising on, or selling, units of such funds to retail investors. Article 33 1. By 31 December 2018, the Commission shall review this Regulation. The review shall include, on the basis of the information received by the ESAs, a general survey of the operation of the comprehension alert, taking into account any guidance developed by competent authorities in this respect. It shall also include a survey of the practical application of the rules laid down in this Regulation, taking due account of developments in the market for retail investment products and the feasibility, costs and possible benefits of introducing a label for social and environmental investments. As part of its review, the Commission shall undertake consumer testing and an examination of non-legislative options as well as the outcomes of the review of Regulation (EU) No 346/2013 regarding points (c), (e) and (g) of Article 27(1)thereof. As regards UCITS as defined in Article 1(2) of Directive 2009/65/EC, the review shall assess whether the transitional arrangements under Article 32 of this Regulation shall be prolonged, or whether, following the identification of any necessary adjustments, the provisions on key investor information in Directive 2009/65/EC might be replaced by or considered equivalent to the key investor document under this Regulation. The review shall also reflect on a possible extension of the scope of this Regulation to other financial products, and shall assess whether the exemption of products from the scope of this Regulation should be maintained, in view of sound standards for consumer protection including comparisons between financial products. The review shall also assess the appropriateness of introducing common rules on the need for all Member States to provide for administrative sanctions for infringements of this Regulation. 2. The Commission shall assess, by 31 December 2018, on the basis of the work undertaken by EIOPA on disclosure of product information requirements, whether to propose a new legislative act guaranteeing appropriate disclosure of product information requirements for those products or whether to include pension products referred to in point (e) of Article 2 (2) in the scope of this Regulation. In making its assessment, the Commission shall ensure that such measures do not reduce standards of disclosure in Member States that have pre-existing disclosure regimes for such pension products. 3. After consulting the Joint Committee, the Commission shall submit a report to the European Parliament and to the Council relating to paragraphs 1 and 2, accompanied, if appropriate, by a legislative proposal. 4. By 31 December 2018, the Commission shall conduct a market survey to determine whether online calculator tools which allow the retail investor to compute the aggregate costs and fees of PRIIPs are available and whether they are free of charge. The Commission shall report on whether those tools provide for reliable and accurate calculations for all products within the scope of this Regulation. In the event that the survey concludes that no such tools exist or that existing tools do not enable retail investors to understand the aggregate amount of costs and fees of PRIIPS, the Commission shall assess the feasibility of the ESAs, through the Joint Committee, developing draft regulatory technical standards setting out the specifications applicable to such Union-level tools. Article 34 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 31 December 2016. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 26 November 2014. For the European Parliament The President M. SCHULZ For the Council The President S. GOZI (1) OJ C 70, 9.3.2013, p. 2. (2) OJ C 11, 15.1.2013, p. 59. (3) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32). (4) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12. 6.2014, p. 349). (5) Directive 2002/92/EC of the European Parliament and of the Council of 9 December 2002 on insurance mediation (OJ L 9, 15.1.2003, p. 3). (6) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12). (7) Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48). (8) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (9) Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading and amending Directive 2001/34/EC (OJ L 345, 31.12.2003, p. 64). (10) Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1). (11) Regulation (EU) No 346/2013 of the European Parliament and of the Council of 17 April 2013 on European social entrepreneurship funds (OJ L 115, 25.4.2013, p. 18). (12) Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84). (13) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') (OJ L 178, 17.7.2000, p. 1). (14) Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC (OJ L 271, 9.10.2002, p. 16). (15) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (16) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (17) OJ C 100, 6.4.2013, p. 12. (18) Directive 2003/41/EC of the European Parliament and of the Council of 3 June 2003 on the activities and supervision of institutions for occupational retirement provision (OJ L 235, 23.9.2003, p. 10). (19) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1). (20) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19).", "summary": "Key information about investment products Key information about investment products SUMMARY OF: Regulation (EU) No 1286/2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) WHAT IS THE AIM OF THE REGULATION? It obliges those who produce or sell investment products to provide retail investors with key information documents (KIDs) about the products. The aim is to help investors to understand and compare the key features and risks of these products. KEY POINTS Key information for retail investors The producer of an investment product intended to be sold to retail investors has to provide a KID concerning the product. Those selling or advising on these investment products have to provide the KID to an investor before any agreement is made. KIDs should be a maximum of three pages long and provide clear information on a product, allowing the investor to take an informed investment decision. KIDs should include the following information: the name of the product and the identity of the producer;the types of investors for whom the financial product is intended;the risk and reward profile of the financial product, which includes a summary risk indicator, the possible maximum loss of invested capital and appropriate performance scenarios of the product;the costs to be borne by the investor associated with the investment in the financial product;information about how and to whom an investor can make a complaint where there is a problem with the product or the person producing, advising on or selling the product. \u2018Comprehension alert\u2019 for investment products that are difficult to understand When an investment product is very difficult to understand, the provider has to ensure the KID contains the following warning: \u2018You are about to purchase a product that is not simple and may be difficult to understand\u2019. Investment products covered The rules apply to packaged retail and insurance-based investment products (also known as PRIIPs). These are a standard range of investment products typically offered by a bank or financial advisers to consumers, for example, in order to save for a specific objective such as a house purchase or a child\u2019s education. They include investment funds, insurance-based investment products, retail-structured securities, structured deposits and structured products. Delegated acts Delegated Regulation (EU) 2017/653, as amended by Delegated Regulation (EU) 2021/2268, supplements Regulation (EU) No 1286/2014. Its Annex I establishes a common template for the KID describing the purpose of the investment product to help investors understand the nature, risks, costs (entry/exit, ongoing and incidental costs), potential gains and losses of the product, and help them compare it with other products. The KID must provide information such as: the name of the product and manufacturer, type of PRIIP, its investment objectives, intended retail investor;risks and return \u2013 a risk indicator including the risk and reward profile, a summary risk indicator, summary-risk-indicator-related narratives, including on possible maximum loss, and performance scenario templates and narratives;what happens if a PRIIP manufacturer is unable to pay out (information about the guarantee / compensation scheme, the risks covered and those not covered);costs over time and the composition of costs;the recommended holding period and information about disinvesting before maturity and applicable fees/penalties, if appropriate;how a retail investor can lodge a complaint. Other aspects are addressed in subsequent annexes: Annex II \u2013 methodology for presenting risk;Annex III \u2013 presentation of the summary risk indicator;Annex IV \u2013 performance scenarios;Annex V \u2013 methodology for presenting performance scenarios;Annex VI \u2013 methodology for calculating costs;Annex VII \u2013 presentation of costs. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2018. BACKGROUND For further information, see: Key information documents for packaged retail and insurance-based investment products (PRIIPs) (European Commission). MAIN DOCUMENT Regulation (EU) No 1286/2014 of the European Parliament and of the Council of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (OJ L 352, 9.12.2014, pp. 1\u201323). Successive amendments to Regulation (EU) No 1286/2014 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2017/653 of 8 March 2017 supplementing Regulation (EU) No 1286/2014 of the European Parliament and of the Council on key information documents for packaged retail and insurance-based investment products (PRIIPs) by laying down regulatory technical standards with regard to the presentation, content, review and revision of key information documents and the conditions for fulfilling the requirement to provide such documents (OJ L 100, 12.4.2017, pp. 1\u201352). See consolidated version. This consolidated version is of documentary value only. last update 21.02.2022"}
{"article": "30.7.2014 EN Official Journal of the European Union L 225/1 REGULATION (EU) No 806/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Over the past decades the Union has made progress in creating an internal market for banking services. A better integrated internal market for banking services is essential in order to foster economic growth in the Union and adequate funding of the real economy. However, the financial and economic crisis has shown that the functioning of the internal market in this area is under threat and that there is an increasing risk of financial fragmentation. This is a real source of concern in an internal market in which banks should be able to carry out significant cross-border activities. Interbank markets have become less liquid and cross-border bank activities are decreasing due to fear of contagion, lack of confidence in other national banking systems and in the ability of Member States to support banks. (2) Divergences between national resolution rules in different Member States and corresponding administrative practices and the lack of a unified decision-making process for resolution in the banking union contribute to that lack of confidence and market instability, as they do not ensure predictability as to the possible outcome of a bank failure. (3) In particular, the different incentives and practices of Member States in the treatment of creditors of banks under resolution and in the bail-out of failing banks with tax payers' money have an impact on the perceived credit risk, financial soundness and solvency of their banks and thus create an unlevel playing field. This undermines public confidence in the banking sector and obstructs the exercise of the freedom of establishment and the free provision of services within the internal market because financing costs would be lower without such differences in practices of Member States. (4) Divergences between national resolution rules in different Member States and corresponding administrative practices may lead banks and customers to have higher borrowing costs only because of their place of establishment and irrespective of their real creditworthiness. In addition, customers of banks in some Member States face higher borrowing rates than customers of banks in other Member States, irrespective of their own creditworthiness. (5) The European Council on 18 October 2012 concluded that, \u2018In the light of the fundamental challenges facing it, the Economic and Monetary Union needs to be strengthened to ensure economic and social welfare as well as stability and sustained prosperity\u2019 and \u2018that the process towards deeper economic and monetary union should build on the Union institutional and legal framework and be characterised by openness and transparency towards Member States whose currency is not the euro and by respect for the integrity of the internal market\u2019. To that end a banking union is established, underpinned by a comprehensive and detailed single rulebook for financial services for the internal market as a whole. The process towards establishing a banking union is characterised by openness and transparency towards non-participating Member States and by respect for the integrity of the internal market. (6) The European Parliament, in its resolution of 7 July 2010 with recommendations to the Commission on Cross-Border Crisis Management in the Banking Sector, requested the Commission to submit \u2018on the basis of Articles 50 and 114 of the Treaty on the Functioning of the European Union, one or more legislative proposals relating to an EU crisis-management framework, an EU financial stability fund, and a resolution unit\u2019 and, in its resolution of 20 November 2012 with recommendations to the Commission on the report of the Presidents of the European Council, the European Commission, the European Central Bank and the Eurogroup \u2018Towards a genuine Economic and Monetary Union\u2019, stated that \u2018breaking up the negative feedback loops between sovereigns, banks and the real economy is crucial for a smooth functioning of the EMU\u2019, stressed the \u2018urgent need for additional and far-reaching measures to solve the crisis in the banking sector\u2019 and for the \u2018realisation of a fully operational European banking union\u2019 while ensuring \u2018the continued proper functioning of the internal market for financial services and the free movement of capital\u2019. (7) As a first step towards a banking union, the single supervisory mechanism established by Council Regulation (EU) No 1024/2013 (4) (the \u2018SSM\u2019) is to ensure that the Union's policy relating to the prudential supervision of credit institutions is implemented in a coherent and effective manner, that the single rulebook for financial services is applied in the same manner to credit institutions in the euro area Member States and those non-euro area Member States who choose to participate in the SSM (the \u2018participating Member States\u2019), and that those credit institutions are subject to supervision of the highest quality. (8) More efficient resolution mechanisms are an essential instrument to avoid damages that have resulted from failures of banks in the past. (9) As long as resolution rules, practices and approaches to burden-sharing remain national and the financial resources needed for funding resolution are raised and spent at national level, the internal market will remain fragmented. Moreover, national supervisors have strong incentives to minimise the potential impact of bank crises on their national economies by adopting unilateral action to ring-fence banking operations, for instance by limiting intra-group transfers and lending, or by imposing higher liquidity and capital requirements on subsidiaries in their jurisdictions of potentially failing parent undertakings. This restricts the cross-border activities of banks and thus creates obstacles to the exercise of fundamental freedoms and distorts competition in the internal market. Contentious home-host issues, although addressed in the context of SSM and of Directive 2014/59/EU of the European Parliament and of the Council (5), may still reduce efficiency in cross-border resolution processes. (10) In order to address those issues it has been necessary to intensify the integration of the resolution framework for credit institutions and investment firms (\u2018institutions\u2019) in order to bolster the Union, restore financial stability and lay the basis for economic recovery. Directive 2014/59/EU is a significant step towards harmonisation of the rules relating to the resolution of banks across the Union and provides for cooperation among resolution authorities when dealing with the failure of cross-border banks. However, that Directive establishes minimum harmonisation rules and does not lead to centralisation of decision making in the field of resolution. It essentially provides for common resolution tools and resolution powers available for the national authorities of every Member State, but leaves discretion to national authorities in the application of the tools and in the use of national financing arrangements in support of resolution procedures. This ensures that authorities have the tools to intervene sufficiently early and quickly in an unsound or failing institution so as to ensure the continuity of the institution's critical financial and economic functions while minimising the impact of an institution's failure on the economy and financial system. Although it confers regulatory and mediation tasks on the European Supervisory Authority (European Banking Authority) (\u2018EBA\u2019), established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council (6), Directive 2014/59/EU does not completely avoid the taking of separate and potentially inconsistent decisions by Member States regarding the resolution of cross-border groups which may affect the overall costs of resolution. Moreover, as it provides for national financing arrangements, it does not sufficiently reduce the dependence of banks on the support from national budgets and does not completely prevent different approaches by Member States to the use of the financing arrangements. (11) For participating Member States, in the context of the Single Resolution Mechanism (SRM), a centralised power of resolution is established and entrusted to the Single Resolution Board established in accordance with this Regulation (\u2018the Board\u2019) and to the national resolution authorities. That establishment is an integral part of the process of harmonisation in the field of resolution operated by Directive 2014/59/EU and by the set of uniform provisions on resolution laid down in this Regulation. The uniform application of the resolution regime in the participating Member States will be enhanced as a result of it being entrusted to a central authority such as the SRM. Furthermore, the SRM is interwoven with the process of harmonisation in the field of prudential supervision, brought about by the establishment of EBA, the single rulebook on prudential supervision (Regulation (EU) No 575/2013 of the European Parliament and of the Council (7) and Directive 2013/36/EU of the European Parliament and of the Council (8)), and, in the participating Member States, the establishment of the SSM to which the application of Union prudential supervision rules is entrusted. Supervision and resolution are two complementary aspects of the establishment of the internal market for financial services whose application at the same level is regarded as mutually dependent. (12) Ensuring effective resolution decisions for failing banks within the Union, including on the use of funding raised at Union level, is essential for the completion of the internal market in financial services. Within the internal market, the failure of banks in one Member State may affect the stability of the financial markets of the Union as a whole. Ensuring effective and uniform resolution rules and equal conditions of resolution financing across Member States is in the best interests not only of the Member States in which banks operate but also of all Member States in general as a means of ensuring a level competitive playing field and improving the functioning of the internal market. Banking systems in the internal market are highly interconnected, bank groups are international and banks have a large percentage of foreign assets. In the absence of the SRM, bank crises in Member States participating in the SSM would have a stronger negative systemic impact also in non-participating Member States. The establishment of the SRM will ensure a neutral approach in dealing with failing banks and therefore increase stability of the banks of the participating Member States and prevent the spill-over of crises into non-participating Member States and will thus facilitate the functioning of the internal market as a whole. The mechanisms for cooperation regarding institutions established in both participating and non-participating Member States should be clear, and no Member State or group of Member States should be discriminated against, directly or indirectly, as a venue for financial services. (13) In order to restore trust and credibility in the banking sector, the European Central Bank (ECB) is currently conducting a comprehensive balance sheet assessment of all banks supervised directly. Such an assessment should assure all stakeholders that banks entering the SSM, and therefore falling within the scope of the SRM, are fundamentally sound and trustworthy. (14) Following the establishment of the SSM by Regulation (EU) No 1024/2013 pursuant to which banks in the participating Member States are supervised either centrally by the ECB or by the national competent authorities within the framework of the SSM, there is a misalignment between the Union supervision of such banks and the national treatment of those banks in the resolution proceedings pursuant to Directive 2014/59/EU which will be addressed by the establishment of the SRM. (15) This Regulation applies only in respect of banks whose home supervisor is the ECB or the national competent authority in Member States whose currency is the euro or in Member States whose currency is not the euro which have established a close cooperation in accordance with Article 7 of Regulation (EU) No 1024/2013. The scope of application of this Regulation is linked to the scope of application of Regulation (EU) No 1024/2013. Indeed, bearing in mind the significant level to which the supervisory tasks attributed to the SSM and resolution action are interwoven, the establishment of a centralised system of supervision operated under Article 127(6) of the Treaty on the Functioning of the European Union (TFEU) is fundamentally important to the process of harmonisation of resolution in participating Member States. The fact of being subject to supervision by the SSM constitutes a specific attribute that places the entities falling within the scope of application of Regulation (EU) No 1024/2013 in an objectively and characterised distinct position for resolution purposes. It is necessary to adopt measures to create an SRM for all Member States participating in the SSM in order to facilitate the proper and stable functioning of the internal market. (16) Whilst banks in Member States remaining outside the SSM are subject to supervision, resolution and financial backstop arrangements which are aligned at national level, banks in Member States participating in the SSM are subject to Union arrangements for supervision and national arrangements for resolution and financial backstops. Because supervision and resolution are at two different levels within the SSM, intervention and resolution in banks in the Member States participating in the SSM would not be as rapid, consistent and effective as in banks in the Member States outside of the SSM. Therefore, a centralised resolution mechanism for all banks operating in the Member States participating in the SSM is essential to guarantee a level playing field. (17) As long as supervision in a Member State remains outside the SSM, that Member State should remain responsible for the financial consequences of a bank failure. The SRM should therefore extend only to banks and financial institutions established in Member States participating in the SSM and subject to the supervision of the ECB and the national authorities within the framework of the SSM. Banks established in the Member States not participating in the SSM should not be subject to the SRM. Subjecting such Member States to the SRM would create the wrong incentives for them. In particular, supervisors in those Member States may become more lenient towards banks in their jurisdictions as they would not have to bear the full financial risk of their failures. Therefore, in order to ensure parallelism with the SSM, the SRM should apply to Member States participating in the SSM. As Member States join the SSM, they should also automatically become subject to the SRM. Ultimately, the SRM could potentially extend to the entire internal market. (18) In order to ensure a level playing field within the internal market as a whole, this Regulation is consistent with Directive 2014/59/EU. It therefore adapts the rules and principles of that Directive to the specificities of the SRM and ensures that appropriate funding is available to the latter. When the Board, the Council and the Commission exercise the powers conferred on them by this Regulation, they should be subject to the delegated acts, and regulatory and implementing technical standards, guidelines and recommendations adopted by EBA on the basis of respectively Articles 10 to 15 and Article 16 of Regulation (EU) No 1093/2010 within the scope of Directive 2014/59/EU. The Board, the Council and the Commission, in their respective capacities, should also cooperate with EBA in accordance with Articles 25 and 30 of Regulation (EU) No 1093/2010 and respond to requests of collection of information addressed to them by EBA in accordance with Article 35 of that Regulation. It is recalled that, according to the last sentence of Recital 32 of that Regulation, \u2018in cases where the relevant Union legislation confers discretion on [\u2026] competent authorities, decisions taken by the Authority cannot replace the exercise in compliance with Union law of that discretion\u2019. The same principle should extend to this Regulation, while fully respecting the principles enshrined in primary Union law. In the light of those key elements EBA should be able to perform its tasks effectively and to secure the equality of treatment between the Board, the Council, the Commission and the national authorities when performing similar tasks. (19) A single resolution fund (\u2018Fund\u2019) is an essential element without which the SRM could not work properly. If the funding of resolution were to remain national in the longer term, the link between sovereigns and the banking sector would not be fully broken, and investors would continue to establish borrowing conditions according to the place of establishment of the banks rather than to their creditworthiness. The Fund should help to ensure a uniform administrative practice in the financing of resolution and to avoid the creation of obstacles for the exercise of fundamental freedoms or the distortion of competition in the internal market due to divergent national practices. The Fund should be financed by bank contributions raised at national level and should be pooled at Union level in accordance with an intergovernmental agreement on the transfer and progressive mutualisation of those contributions (the \u2018Agreement\u2019), thus increasing financial stability and limiting the link between the perceived fiscal position of individual Member States and the funding costs of banks and undertakings operating in those Member States. To further break that link, decisions taken within the SRM should not impinge on the fiscal responsibilities of the Member States. In that regard, only extraordinary public financial support should be considered to be an impingement on the budgetary sovereignty and fiscal responsibilities of the Member States. In particular, decisions that require the use of the Fund or of a deposit guarantee scheme should not be considered to impinge on the budgetary sovereignty or fiscal responsibilities of the Member States. (20) This Regulation, together with Directive 2014/59/EU, establishes the modalities for the use of the Fund and the general criteria to determine the fixing and calculation of ex-ante and ex-post contributions. Participating Member States remain competent to levy the contributions from the entities located in their respective territories in accordance with Directive 2014/59/EU and with this Regulation. By means of the Agreement, the participating Member States will assume the obligation to transfer to the Fund the contributions that they raise at national level in accordance with Directive 2014/59/EU and this Regulation. During a transitional period, the contributions will be allocated to different compartments corresponding to each participating Member State (national compartments). Those compartments will be subject to a progressive merger so that they will cease to exist at the end of the transitional period. The Agreement will lay down the conditions upon which the parties thereto agree to transfer the contributions that they raise at national level to the Fund and to progressively merge the compartments. The entry into force of the Agreement will be necessary for the contributions raised by the parties to be transferred to the national compartments of the Fund. This Regulation lays down the powers of the Board for using and managing the Fund. The Agreement will determine how the Board is able to dispose of the national compartments that are progressively merged. (21) A centralised application of the resolution rules for institutions laid down in Directive 2014/59/EU by a single Union resolution authority in the participating Member States can be ensured only where the rules governing the establishment and functioning of the SRM are directly applicable in the Member States to avoid divergent interpretations across the Member States. Such direct applicability should bring benefits to the internal market as a whole because it will contribute to ensuring fair competition and to preventing obstacles to the free exercise of fundamental freedoms not only in the participating Member States but in the internal market as a whole. (22) Mirroring the scope of Regulation (EU) No 1024/2013, the SRM should cover all credit institutions established in the participating Member States. However, within the framework of the SRM, it should be possible to resolve directly any credit institution of a participating Member State in order to avoid asymmetries within the internal market in respect of the treatment of failing institutions and creditors during a resolution process. To the extent that parent undertakings, investment firms and financial institutions are included in the consolidated supervision by the ECB, they should be included in the scope of the SRM. Although the ECB will not supervise those institutions on a solo basis, it will be the only supervisor that will have a global perception of the risk which a group, and indirectly its individual members, is exposed to. To exclude entities which form part of the consolidated supervision within the scope of the ECB from the scope of the SRM would make it impossible to plan for the resolution of groups and to adopt a group resolution strategy, and would make any resolution decisions much less effective. (23) Within the SRM, decisions should be taken at the most appropriate level. When adopting decisions under this Regulation, the Board and the national resolution authorities should apply the same material rules. (24) Since only institutions of the Union may establish the resolution policy of the Union and since a margin of discretion remains in the adoption of each specific resolution scheme, it is necessary to provide for the adequate involvement of the Council and the Commission, as institutions which may exercise implementing powers, in accordance with Article 291 TFEU. The assessment of the discretionary aspects of the resolution decisions taken by the Board should be exercised by the Commission. Given the considerable impact of the resolution decisions on the financial stability of Member States and on the Union as such, as well as on the fiscal sovereignty of Member States, it is important that implementing power to take certain decisions relating to resolution be conferred on the Council. It should therefore be for the Council, on a proposal from the Commission, to exercise effective control on the assessment by the Board of the existence of a public interest and to assess any material change to the amount of the Fund to be used in a specific resolution action. Moreover, the Commission should be empowered to adopt delegated acts to specify further criteria or conditions to be taken into account by the Board in the exercise of its different powers. Such a conferral of resolution tasks should not in any way hamper the functioning of the internal market for financial services. EBA should therefore maintain its role and retain its existing powers and tasks: it should develop and contribute to the consistent application of the Union legislation applicable to all Member States and enhance convergence of resolution practices across the Union as a whole. (25) In order to ensure conformity with the principles established in Article 3(3) of Directive 2014/59/EU, the Union institutions, when performing the tasks conferred on them by this Regulation, should ensure that appropriate organisational arrangements are in place. (26) The ECB, as the supervisor within the SSM, and the Board, should be able to assess whether a credit institution is failing or is likely to fail and whether there is no reasonable prospect that any alternative private sector or supervisory action would prevent its failure within a reasonable timeframe. The Board, if it considers all the criteria relating to the triggering of resolutions to be met, should adopt the resolution scheme. The procedure relating to the adoption of the resolution scheme, which involves the Commission and the Council, strengthens the necessary operational independence of the Board while respecting the principle of delegation of powers to agencies as interpreted by the Court of Justice of the European Union (the \u2018Court of Justice\u2019). Therefore, this Regulation provides that the resolution scheme adopted by the Board enters into force only if, within 24 hours after its adoption by the Board, there are no objections from the Council or the Commission or the resolution scheme is approved by the Commission. The grounds on which the Council is permitted to object, on a proposal by the Commission, to the Board's resolution scheme should be strictly limited to the existence of a public interest and to material modifications by the Commission of the amount of the use of the Fund as proposed by the Board. A change of 5 % or more to the amount of the Fund compared with the original proposal of the Board should be considered to be material. The Council should approve or object to the Commission's proposal without amending it. As an observer to the meetings of the Board, the Commission should, on an ongoing basis, check that the resolution scheme adopted by the Board complies fully with this Regulation, balances appropriately the different objectives and interests at stake, respects the public interest and that the integrity of the internal market is preserved. Considering that the resolution action requires a very speedy decision-making process, the Council and the Commission should cooperate closely and the Council should not duplicate the preparatory work already undertaken by the Commission. The Board should instruct the national resolution authorities which should take all necessary measures to implement the resolution scheme. (27) The production of a group resolution scheme should facilitate coordinated resolution that is more likely to deliver the best result for all entities of a group. The Board or, where relevant, the national resolution authorities should have the power to apply the bridge institution tool at group level (which may involve, where appropriate, burden-sharing arrangements) to stabilise a group as a whole. Ownership of subsidiaries could be transferred to the bridge institution with a view to onward sale, either as a package or individually, when market conditions are appropriate. In addition, the Board or, where relevant, the national resolution authority should have the power to apply the bail-in tool at parent level. (28) The Board should, in particular, be empowered to take decisions in relation to significant entities or groups, entities or groups directly supervised by the ECB or cross-border groups. The national resolution authorities should assist the Board in resolution planning and in the preparation of resolution decisions. For entities and groups which are not significant and not cross-border, the national resolution authorities should be responsible, in particular, for resolution planning, the assessment of resolvability, the removal of impediments to resolvability, the measures that the resolution authorities are entitled to take during early intervention, and resolution actions. Under certain circumstances the national resolution authorities should perform their tasks on the basis of and in accordance with this Regulation while exercising the powers conferred on them by, and in accordance with, the national law transposing Directive 2014/59/EU in so far as it is not in conflict with this Regulation. (29) It is essential for the good functioning of the internal market that the same rules apply to all resolution actions, regardless of whether they are taken by the resolution authorities under Directive 2014/59/EU or within the framework of the SRM. The Commission should assess those measures under Article 107 TFEU. (30) Where resolution action would involve the granting of State aid pursuant to Article 107(1) TFEU or as Fund aid, a resolution decision can be adopted after the Commission has adopted a positive or conditional decision concerning the compatibility of the use of such aid with the internal market. The decision of the Commission on Fund aid may impose conditions, commitments or undertakings in respect of the beneficiary. The conditions which may be imposed by the Commission may include, but are not limited to, burden-sharing requirements, including a requirement that losses are first absorbed by equity, and requirements as to contributions by hybrid capital holders, subordinated debt holders and senior creditors, including in accordance with the requirements of Directive 2014/59/EU; restrictions on the payment of dividends on shares or coupons on hybrid capital instruments, on the repurchase of own shares or hybrid capital instruments, or on capital management transactions; restrictions on acquisitions of stakes in any undertaking either through an asset or share transfer; prohibitions against aggressive commercial practices or strategies, or advertising support from public aid; requirements concerning market shares, pricing, product features or other behavioural requirements; requirements for restructuring plans; governance requirements; reporting and disclosure requirements, including as regards compliance with such conditions as may be specified by the Commission; requirements relating to the sale of the beneficiary or of all or part of its assets, rights and liabilities; requirements relating to the liquidation of the beneficiary. (31) In order to ensure a swift and effective decision-making process in resolution, the Board should be a specific Union agency with a specific structure, corresponding to its specific tasks, and which departs from the model of all other agencies of the Union. Its composition should ensure that due account is taken of all relevant interests at stake in resolution procedures. Taking into account the missions of the Board, a Chair, a Vice-Chair and four further full-time members of the Board should be appointed on the basis of merit, skills, knowledge of banking and financial matters, and experience relevant to financial supervision, regulation and resolution of institutions. The Chair, the Vice-Chair and the four further full-time members of the Board should be chosen on the basis of an open selection procedure of which the European Parliament and the Council should be kept duly informed and which should respect the principle of gender balance, experience and qualification. The Commission should provide the competent committee of the European Parliament with the shortlist of candidates for the positions of Chair, Vice-Chair and the four further full-time members of the Board. The Commission should submit a proposal for the appointment of the Chair, the Vice-Chair and the four further full-time members of the Board to the European Parliament for approval. Following the European Parliament's approval of that proposal, the Council should adopt an implementing decision to appoint the Chair, the Vice-Chair and the four further full-time members of the Board. (32) The Board should operate in executive and plenary sessions. In its executive session, it should be composed of its Chair, its four further independent full-time members, which should act independently and objectively in the interest of the Union as a whole, and permanent observers appointed by the Commission and by the ECB. When deliberating on the resolution of an institution or group established within a single participating Member State, the executive session of the Board should convene and involve in the decision-making process the member appointed by the Member State concerned representing its national resolution authority. When deliberating on a cross-border group, the members appointed by the home and all host Member States concerned representing the relevant national resolution authorities should be convened and involved in the decision-making process of the executive session of the Board. (33) The Board, in its executive session, should prepare all decisions concerning resolution procedure and, to the fullest extent possible, adopt those decisions. Because of the institution-specific nature of the information contained in the resolution plans, decisions concerning the drawing up, assessment, and approval of the resolution plans should be taken by the Board in its executive session. Regarding the use of the Fund, it is important that there is no first-mover advantage and that the outflows of the Fund are monitored. In order to ensure corresponding decision making by the Board, where resolution action is required above the threshold of EUR 5 000 000 000, any member of the plenary should be able, within a strict deadline, to request that the plenary session decide. Where liquidity support involves no or significantly less risk than other forms of support, in particular in the case of a short-term, one-off extension of credit to solvent institutions against adequate collateral of high quality, it is justified to give such a form of support a lower weight of only 0,5. Once the net accumulated use of the Fund in the previous consecutive 12 months reaches the threshold of EUR 5 000 000 000 per year, the plenary session should evaluate the application of the resolution tools, including the use of the Fund, and should provide guidance which the executive session should follow in subsequent resolution decisions. Guidance to the executive session should, in particular, focus on ensuring the non-discriminatory application of resolution tools, on avoiding a depletion of the Fund and differentiating appropriately between no-risk or low-risk liquidity and other forms of support. (34) Since the participants in the decision-making process of the Board in its executive sessions would change depending on the Member State where the relevant institution or group operates, the permanent participants should ensure that the decisions throughout the different formations of the executive sessions of the Board are consistent, appropriate and proportionate. (35) The Board should be able to invite observers to its meetings. The conferral of resolution tasks on the Board should be consistent with the framework of the European System of Financial Supervision (\u2018ESFS\u2019) and its underlying objective to develop the single rulebook and enhance convergence of supervisory and resolution practices across the Union as a whole. In particular, EBA should assess and coordinate initiatives, in accordance with Regulation (EU) No 1093/2010, on resolution plans with a view to promoting convergence in that area. Therefore, as a general rule, the Board should always invite EBA when matters are discussed for which, in accordance with Directive 2014/59/EU, EBA is required to develop technical standards or to issue guidelines. Other observers, such as a representative of the European Stability Mechanism (ESM), may, where appropriate, also be invited to attend the meetings of the Board. (36) The observers should be subject to the same requirements of professional secrecy as the members and the staff of the Board and staff exchanged with or seconded by participating Member States carrying out resolution duties. (37) The Board should be able to establish internal resolution teams composed of its own staff and staff of the national resolution authorities, including, where appropriate, observers from non-participating Member States. Those internal resolution teams should be headed by coordinators appointed from the Board's senior staff, who might be invited as observers to participate in the executive sessions of the Board. (38) The Board and the resolution authorities and competent authorities of the non-participating Member States should conclude memoranda of understanding describing in general terms how they will cooperate with one another in the performance of their tasks under Directive 2014/59/EU. The memoranda of understanding could, inter alia, clarify the consultation relating to decisions of the Board that have effect on subsidiaries established or branches located in the non-participating Member States, where the parent undertaking is established in a participating Member State. The memoranda should be reviewed on a regular basis. (39) The Board should act independently. It should have the capacity to deal with large groups and to act swiftly and impartially. The Board should ensure that appropriate account is taken of national financial stability, financial stability of the Union and the internal market. Members of the Board should have the necessary expertise on bank restructuring and insolvency. (40) When making decisions or taking actions in the exercise of the powers conferred by this Regulation, due account should be given to the importance for the internal market of the exercise of the right of establishment provided for in the TFEU, and, in particular, where possible, to the effects on the continuation of cross-border activities. (41) In the light of the Board's missions and the resolution objectives which include the protection of public funds, the functioning of the SRM should be financed from contributions paid by the institutions established in the participating Member States. (42) The Board, the Council where relevant, and the Commission should replace the national resolution authorities designated under Directive 2014/59/EU in respect of all aspects relating to the resolution decision-making process. The national resolution authorities designated under that Directive should continue to carry out activities relating to the implementation of resolution schemes adopted by the Board. In order to ensure transparency and democratic control, as well as to safeguard the rights of the Union institutions, the Board should be accountable to the European Parliament and to the Council for any decisions taken on the basis of this Regulation. For reasons of transparency and democratic control, national parliaments should have certain rights to obtain information about the activities of, and to engage in a dialogue with, the Board. (43) The national parliament of a participating Member State, or the competent committee thereof, should be able to invite the Chair to participate in an exchange of views in relation to the resolution of institutions in that Member State together with a representative of the national resolution authority. Such a role for national parliaments is appropriate given the potential impact that resolution actions may have on public finances, institutions, their customers and employees, and the markets in the participating Member States. The Chair and the national resolution authorities should respond positively to such invitations to exchange views with the national parliaments. (44) To ensure a uniform approach for institutions and groups the Board should be empowered to draw up resolution plans for such institutions and groups, after consulting the national competent and resolution authorities. It should be the general rule that the group resolution plans are prepared for the group as a whole and identify measures in relation to a parent undertaking as well as all individual subsidiaries that are part of a group. The group resolution plans should take into account the financial, technical and business structure of the relevant group. If individual resolution plans for entities that are a part of a group are prepared, the Board or, where relevant, the national resolution authorities should aim to achieve, to the extent possible, consistency with resolution plans for the rest of the group. The Board or, where relevant, the national resolution authorities should transmit the resolution plans and any changes thereto to the competent authority, in order to permanently keep it fully informed. The Board should assess the resolvability of institutions and groups, and take measures aimed at removing impediments to resolvability, if any. The Board should require the national resolution authorities to apply such appropriate measures designed to remove impediments to resolvability in order to ensure consistency and the resolvability of the institutions concerned. Given the sensitivity of the information contained in them, resolution plans should be subject to the requirements of professional secrecy laid down in this Regulation. (45) When applying resolution tools and exercising resolution powers, the principle of proportionality and the particularities of the legal form of an institution should be taken into account. (46) Resolution planning is an essential component of effective resolution. The Board should therefore have the power to require changes to the structure and organisation of institutions or groups to take measures which are necessary and proportionate to reduce or remove material impediments to the application of resolution tools and ensure the resolvability of the entities concerned. Due to the potentially systemic nature of all institutions, it is crucial, in order to maintain financial stability, that the Board, or, where relevant, the national resolution authorities, have the possibility to resolve any institution. In order to respect the right to conduct business laid down by Article 16 of the Charter of Fundamental Rights of the European Union (the \u2018Charter\u2019), the Board's discretion should be limited to what is necessary to simplify the structure and operations of the institution solely to improve its resolvability. In addition, any measure imposed for such purposes should be consistent with Union law. Measures should neither directly nor indirectly be discriminatory on grounds of nationality, and should be justified by the overriding reason of being conducted in the public interest in financial stability. To determine whether an action was taken in the general public interest, the Board, acting in the general public interest, should be able to achieve the resolution objectives without encountering impediments to the application of resolution tools or its ability to exercise the powers conferred on it by this Regulation. Furthermore, action should not go beyond the minimum necessary to attain the objectives sought. When determining the measures to be taken, the Board or, where applicable, the national resolution authorities should take into account the warnings and recommendations of the European Systemic Risk Board (\u2018ESRB\u2019) established by Regulation (EU) No 1092/2010 of the European Parliament and of the Council (9). (47) Due to the potentially systemic nature of all institutions, it is crucial that the Board, where appropriate in cooperation with the national resolution authorities, is able to adopt resolution plans, assess the resolvability of any institution and group and, where necessary, take measures to address or remove impediments to the resolvability of any institution in the participating Member States. The failure of systemically important institutions, including those referred to in Article 131 of Directive 2013/36/EU, could pose a considerable risk to the functioning of the financial markets and could have a negative impact on financial stability. The Board should take due care, as a matter of priority, to establish the resolution plans of those systemically important institutions, as well as to assess their resolvability and to take all action necessary to address or remove all of the impediments to their resolvability, without prejudice to its independence and to its obligation to plan for the resolution and assess the resolvability of all of the institutions subject to its powers. (48) Resolution plans should include procedures for informing and consulting employee representatives throughout the resolution processes where appropriate. Where applicable, collective agreements or other arrangements provided for by social partners, as well as by Union and national law on the involvement of trade unions and workers' representatives in company restructuring processes, should be complied with in that regard. (49) In relation to the obligation of drafting resolution plans, the Board, or, where relevant, the national resolution authorities, in the context of resolution plans and when using the different powers and tools at their disposal, should take into account the nature of an entity's business, shareholding structure, legal form, risk profile, size and legal status and interconnectedness to other institutions or to the financial system in general, the scope and complexity of its activities, whether it is a member of an institutional protection scheme (IPS) or other cooperative mutual solidarity systems, whether it exercises any investment services or activities and whether its failure and subsequent winding up under normal insolvency proceedings would be likely to have a significant negative effect on financial markets, on other institutions, on funding conditions, or on the wider economy, ensuring that the regime is applied in an appropriate and proportionate way and that the administrative burden relating to resolution plan preparation obligations is minimised. Whereas the contents and information specified in Section A of the Annex to Directive 2014/59/EU establish a minimum standard for entities with evident systemic relevance, it is permitted to apply different or significantly reduced resolution planning and information requirements on an institution-specific basis, and at a lower frequency for updates than one year. For a small entity of little interconnectedness and complexity, the resolution plan could be reduced. Further, the regime should be applied so as not to jeopardise the stability of financial markets. In particular, in situations characterised by broader problems or even doubts about the resilience of many entities, it is essential to consider the risk of contagion from the actions taken in relation to any individual entity. (50) Where Directive 2014/59/EU provides for the possibility of applying simplified obligations or waivers by the national resolution authorities in relation to the requirement of drafting resolution plans, a procedure should be provided for whereby the Board or, where relevant, the national resolution authorities could authorise the application of such simplified obligations. (51) In line with the capital structure of entities affiliated to a central body, for the purposes of this Regulation, the Board, or, where relevant, the national resolution authorities, should not be obliged to draw up separate resolution plans solely on the grounds that the central body to which those entities are affiliated is under direct supervision of the ECB. In the case of group resolution plans, the potential impact of the resolution actions in all the Member States where the group operates should be specifically taken into account in the drawing up of the plans. (52) The SRM should be based on the frameworks of Regulation (EU) No 1024/2013 and of Directive 2014/59/EU. Therefore, the Board should be empowered to intervene at an early stage where the financial situation or the solvency of an entity is deteriorating. The information that the Board receives from the national resolution authorities or the ECB at that stage is instrumental in making a determination on the action it might take in order to prepare for the resolution of the entity concerned. (53) In order to ensure rapid resolution action when it becomes necessary, the Board should closely monitor, in cooperation with the ECB or with the relevant national competent authority, the situation of the entities concerned and the compliance of those entities with any early intervention measure taken in their respect. In determining whether a private sector action could prevent within a reasonable timeframe the failure of an entity, the appropriate authority should take into account the effectiveness of early intervention measures undertaken within a timeframe set by the competent authority. (54) The Board, the national resolution authorities and the competent authorities, including the ECB, should, where necessary, conclude a memorandum of understanding describing in general terms how they will cooperate with one another in the performance of their respective tasks under Union law. The memorandum should be reviewed on a regular basis. (55) When making decisions or taking actions, in particular regarding entities established both in participating Member States and in non-participating Member States, possible adverse effects on those Member States, such as threats to the financial stability of their financial markets, and on the entities established in those Member States, should also be taken into consideration. (56) In order to minimise disruption of the financial market and of the economy, the resolution process should be accomplished in a short time. Depositors should be granted access at least to the guaranteed deposits as promptly as possible, and in any event within the same deadlines as provided for in Directive 2014/49/EU of the European Parliament and of the Council (10). The Commission should, throughout the resolution procedure, have access to any information which it deems to be necessary to take an informed decision in the resolution process. (57) The decision to place an entity under resolution should be taken before a financial entity is balance sheet insolvent and before all equity has been fully wiped out. Resolution should be initiated after the determination that an entity is failing or is likely to fail and that no alternative private sector measures would prevent such failure within a reasonable timeframe. The fact that an entity does not meet the requirements for authorisation should not justify per se the entry into resolution, especially if the entity remains or is likely to remain viable. An entity should be considered to be failing or likely to fail where it infringes or is likely, in the near future, to infringe the requirements for continuing authorisation, where the assets of the entity are, or are likely in the near future to be, less than its liabilities, where the entity is, or is likely in the near future to be, unable to pay its debts as they fall due, or where the entity requires extraordinary public financial support except in the particular circumstances laid down in this Regulation. The need for emergency liquidity assistance from a central bank should not, per se, be a condition that sufficiently demonstrates that an entity is, or is likely in the near future to be, unable to pay its liabilities as they fall due. If that facility were guaranteed by a State, an entity accessing such a facility would be subject to State aid rules. In order to preserve financial stability, in particular in the event of a systemic liquidity shortage, State guarantees of liquidity facilities provided by central banks or State guarantees of newly issued liabilities to remedy a serious disturbance in the economy of a Member State should not trigger the resolution framework provided that a number of conditions are met. In particular, the State guarantee measures should be approved under the State aid framework and should not be part of a larger aid package, and the use of the guarantee measures should be strictly limited in time. Member States' guarantees for equity claims should be prohibited. When providing a guarantee, a Member State should ensure that the guarantee is sufficiently remunerated by the entity. Furthermore, the provision of extraordinary public financial support should not trigger resolution where, as a precautionary measure, a Member State takes an equity stake in an entity, including an entity which is publicly owned, which complies with its capital requirements. That may be the case, for example, where an entity is required to raise new capital due to the outcome of a scenario-based stress test or of the equivalent exercise conducted by macroprudential authorities which includes a requirement that is set to maintain financial stability in the context of a systemic crisis, but the entity is unable to raise capital privately in markets. An entity should not be considered to be failing or likely to fail solely on the basis that extraordinary public financial support was provided before the entry into force of this Regulation. Finally, access to liquidity facilities including emergency liquidity assistance by central banks may constitute State aid pursuant to the State aid framework. (58) Liquidation of a failing entity under normal insolvency proceedings could jeopardise financial stability, interrupt the provision of essential services, and affect the protection of depositors. In such a case there is a public interest in applying resolution tools. The objectives of resolution should therefore be to ensure the continuity of essential financial services, to maintain the stability of the financial system, to reduce moral hazard by minimising reliance on public financial support to failing entities, and to protect depositors. (59) However, the winding up of an insolvent entity through normal insolvency proceedings should always be considered before a decision is taken to maintain the entity as a going concern. An insolvent entity should be maintained as a going concern for financial stability purposes and with the use, to the extent possible, of private funds. That may be achieved either through sale to or merger with a private sector purchaser, or after having written down the liabilities of the entity, or after converting its debt to equity in order to effect a recapitalisation. (60) When taking or preparing decisions relating to resolution powers, the Board, the Council and the Commission should ensure that resolution action is taken in accordance with certain principles, including that shareholders and creditors bear an appropriate share of the losses, that the management should in principle be replaced, that the costs of the resolution of the entity are minimised, and that creditors of the same class are treated in an equitable manner. In particular, where creditors within the same class are treated differently in the context of resolution action, such distinctions should be justified in the public interest and should be neither directly nor indirectly discriminatory on the grounds of nationality. (61) The limitations on the rights of shareholders and creditors should comply with Article 52 of the Charter. The resolution tools should therefore be applied only to those entities that are failing or likely to fail, and only where necessary to pursue the objective of financial stability in the general interest. In particular, resolution tools should be applied where the entity cannot be wound up under normal insolvency proceedings without destabilising the financial system and the measures are necessary in order to ensure the rapid transfer and continuation of systemically important functions and where there is no reasonable prospect for any alternative private solution, including any increase of capital by the existing shareholders or by any third party, sufficient to restore the full viability of the entity. (62) Interference with property rights should not be disproportionate. As a consequence, affected shareholders and creditors should not incur greater losses than those which they would have incurred had the entity been wound up at the time that the resolution decision is taken. In the event of partial transfer of assets of an institution under resolution to a private purchaser or to a bridge institution, the residual part of the institution under resolution should be wound up under normal insolvency proceedings. In order to protect shareholders and creditors of the entity during the winding up proceedings, they should be entitled to receive in payment of their claims not less than what it is estimated they would have recovered if the entity as a whole had been wound up under normal insolvency proceedings. (63) For the purpose of protecting the rights of shareholders and creditors, clear obligations should be laid down concerning the valuation of the assets and liabilities of the institution under resolution and, where required under this Regulation, the valuation of the treatment that shareholders and creditors would have received if the entity had been wound up under normal insolvency proceedings. It should be possible to commence a valuation already in the early intervention phase. Before any resolution action is taken, a fair, prudent and realistic valuation of the assets and liabilities of the entity should be carried out. Such valuation should be subject to a right of appeal only together with the resolution decision. In addition, where required under this Regulation, an ex-post comparison between the treatment that shareholders and creditors have received and the treatment they would have received under normal insolvency proceedings should be carried out after resolution tools have been applied. If it is determined that shareholders and creditors have received, in payment of their claims, less than the amount that they would have received under normal insolvency proceedings, they should be entitled to the payment of the difference where required under this Regulation. That difference, if any, should be paid by the Fund established in accordance with this Regulation. (64) It is important that losses be recognised upon failure of the entity. The valuation of assets and liabilities of failing entities should be based on fair, prudent and realistic assumptions at the moment when the resolution tools are applied. The value of liabilities should not, however, be affected in the valuation by the entity's financial state. It should be possible, for reasons of urgency, that the Board makes a rapid valuation of the assets or the liabilities of a failing entity. That valuation should be provisional and should apply until an independent valuation is carried out. (65) In order to ensure that the resolution process remains objective and certain, it is necessary to lay down the order in which unsecured claims of creditors against an institution under resolution should be written down or converted. In order to limit the risk of creditors incurring greater losses than if the institution had been wound up under normal insolvency proceedings, the order to be laid down should be applicable both in normal insolvency proceedings and in the write-down or conversion process under resolution. This would also facilitate the pricing of debt. (66) The Board should decide on the detailed resolution scheme. The relevant resolution tools should include the sale of business tool, the bridge institution tool, the bail-in tool and the asset separation tool, which are also provided for in Directive 2014/59/EU. The scheme should also make it possible to assess whether the conditions for the write-down and conversion of capital instruments are met. (67) When taking resolution actions, the Board should take into account and follow the measures provided for in the resolution plans unless the Board assesses, taking into account the circumstances of the case, that resolution objectives will be achieved more effectively by taking actions which are not provided for in those resolution plans. (68) The resolution tools should include the sale of the business or shares of the institution under resolution, the setting up of a bridge entity, the separation of the performing assets from the impaired or under-performing assets of the failing entity, and the bail-in of the shareholders and creditors of the failing entity. (69) Where the resolution tools have been used to transfer the systemically important services or viable business of an entity to a sound entity such as a private sector purchaser or bridge entity, the residual part of the entity should be liquidated. (70) The sale of business tool should enable the sale of the entity or parts of its business to one or more purchasers without the consent of shareholders. (71) Any net proceeds from the transfer of assets or liabilities of the institution under resolution when applying the sale of business tool should benefit the entity left in the winding-up proceedings. Any net proceeds from the transfer of instruments of ownership issued by the institution under resolution when applying the sale of business tool should benefit the owners of those instruments of ownership in the entity left in the winding up proceedings. Proceeds should be calculated net of the costs arisen from the failure of the entity and from the resolution process. (72) The asset separation tool should enable authorities to transfer assets, rights or liabilities of an institution under resolution to a separate vehicle. That tool should be used only in conjunction with other tools to prevent an undue competitive advantage for the failing entity. (73) An effective resolution regime should minimise the costs of the resolution of a failing entity borne by the taxpayers. It should also ensure that systemic entities can be resolved without jeopardising financial stability. The bail-in tool achieves that objective by ensuring that shareholders and creditors of the failing entity suffer appropriate losses and bear an appropriate part of the costs arising from the failure of the entity. The bail-in tool will therefore give shareholders and creditors of entities a stronger incentive to monitor the health of an entity during normal circumstances. It also meets the Financial Stability Board recommendation that statutory debt write-down and conversion powers be included in a framework for resolution, as an additional option in conjunction with other resolution tools. (74) In order to ensure the necessary flexibility to allocate losses to creditors in a range of circumstances, it is appropriate that the bail-in tool be applicable both where the objective is to resolve the failing entity as a going concern if there is a realistic prospect that the entity viability may be restored, and where systemically important services are transferred to a bridge entity and the residual part of the entity ceases to operate and is wound down. (75) Where the bail-in tool is applied with the objective of restoring the capital of the failing entity to enable it to continue to operate as a going concern, the resolution through bail-in should be accompanied by replacement of management, except where retention of management is appropriate and necessary for the achievement of the resolution objectives, and a subsequent restructuring of the entity and its activities in a way that addresses the reasons for its failure. That restructuring should be achieved through the implementation of a business reorganisation plan. Where applicable, such plans should be compatible with the restructuring plan that the entity is required to submit to the Commission under the Union State aid framework. In particular, in addition to measures aiming at restoring the long term viability of the entity, the plan should include measures limiting the aid to the minimum burden sharing, and measures limiting distortions of competition. (76) It is not appropriate to apply the bail-in tool to claims in so far as they are secured, collateralised or otherwise guaranteed. However, in order to ensure that the bail-in tool is effective and achieves its objectives, it is desirable that it can be applied to as wide a range of the unsecured liabilities of a failing entity as possible. Nevertheless, it is appropriate to exclude certain kinds of unsecured liability from the scope of application of the bail-in tool. In order to protect holders of covered deposits, the bail-in tool should not apply to those deposits that are protected under Directive 2014/49/EU. In order to ensure continuity of critical functions, the bail-in tool should not apply to certain liabilities to employees of the failing entity or to commercial claims that relate to goods and services critical for the daily functioning of the entity. In order to honour pension entitlements and pension amounts owed or owing to pension trusts and pension trustees, the bail-in tool should not apply to the failing entity's liabilities to a pension scheme, except for liabilities for pension benefits attributable to variable remuneration which do not arise from collective bargaining agreements. To reduce risk to systemic contagion, the bail-in tool should not apply to liabilities arising from a participation in payment systems which have a remaining maturity of less than seven days, or liabilities to entities, excluding entities that are part of the same group, with an original maturity of less than seven days. (77) It should be possible to exclude or partially exclude liabilities in a number of circumstances, including where it is not possible to bail-in such liabilities within a reasonable timeframe, where the exclusion is strictly necessary and is proportionate to achieving the continuity of critical functions and core business lines, or where the application of the bail-in tool to liabilities would cause a destruction in value such that losses borne by other creditors would be higher than if those liabilities were not excluded from bail-in. It should also be possible to exclude or partially exclude liabilities where necessary to avoid the spreading of contagion and financial instability which may cause serious disturbance to the economy of a Member State. When carrying out the assessments, the Board or, where relevant, the national resolution authorities should give consideration to the consequences of a potential bail-in of liabilities stemming from eligible deposits held by natural persons and micro, small and medium-sized enterprises above the coverage level provided for in Directive 2014/49/EU. (78) Where those exclusions are applied, the level of write-down or conversion of other eligible liabilities may be increased to take account of such exclusions subject to the \u2018no creditor worse off than under normal insolvency proceedings\u2019 principle being respected. Where the losses cannot be passed to other creditors, the Fund may make a contribution to the institution under resolution subject to a number of strict conditions including the requirement that losses totalling not less than 8 % of total liabilities including own funds have already been absorbed, and the funding provided by the Fund is limited to the lower of 5 % of total liabilities including own funds or the means available to the Fund and the amount that can be raised through ex-post contributions within three years. (79) In extraordinary circumstances, where liabilities have been excluded and the Fund has been used to contribute to bail-in in lieu of those liabilities up to the permissible cap, the Board should be able to seek funding from alternative funding means. (80) The minimum amount of bail-in of 8 % of total liabilities referred to in this Regulation should be calculated based on the valuation conducted in accordance with this Regulation. Historical losses which have already been absorbed by shareholders through a reduction in own funds prior to that valuation should not be included in that percentage. (81) As the protection of covered depositors is one of the most important objectives of resolution, covered deposits should not be subject to the exercise of the bail-in tool. The deposit guarantee scheme, however, contributes to funding the resolution process by absorbing losses to the extent of the net losses that it would have had to suffer after compensating depositors in normal insolvency proceedings. The exercise of the bail-in powers would ensure that depositors continue to have access to their deposits which is the main reason why the deposit guarantee schemes have been established. Not providing for the involvement of those schemes in such cases would constitute an unfair advantage with respect to the remaining creditors which would be subject to the exercise of the powers by the resolution authority. (82) Where deposits are transferred to another entity in the context of the resolution of an entity, depositors should not be insured beyond the coverage level provided for in Directive 2014/49/EU. Therefore, claims with regard to deposits remaining in the institution under resolution should be limited to the difference between the funds transferred and the coverage level provided for in Directive 2014/49/EU. Where transferred deposits are superior to the coverage level, the depositor should have no claim against the deposit guarantee scheme with regard to deposits remaining in the institution under resolution. (83) To avoid entities structuring their liabilities in a manner that impedes the effectiveness of the bail-in tool, it is appropriate to establish that the entities should meet at all times a minimum requirement for own funds and eligible liabilities which may be subject to the bail-in tool, expressed as a percentage of the total liabilities and own funds of the entity. (84) A top-down approach should be adopted when determining the minimum requirement for own funds and eligible liabilities within a group. That approach should recognise that resolution action is applied at the level of the individual legal entity, and that it is imperative that loss absorbing capacity is located in, or is accessible to, the entity within the group where losses occur. To that end, it should be ensured that loss absorbing capacity within a group is distributed across the group in accordance with the level of risk in its constituent legal entities. The minimum requirement for own funds and eligible liabilities necessary for each individual subsidiary should be separately assessed. Furthermore, it should be ensured that all capital and liabilities which are counted towards the consolidated minimum requirement for own funds and eligible liabilities are located in entities where losses are likely to occur, or are otherwise available to absorb losses. This Regulation should allow for a multiple-point-of-entry or a single-point-of-entry resolution. The minimum requirement for own funds and eligible liabilities should reflect the resolution strategy which is appropriate to a group in accordance with the resolution plan. In particular, the minimum requirement for own funds and eligible liabilities should be required at the appropriate level in the group in order to reflect a multiple-point-of-entry or a single-point-of-entry approach contained in the resolution plan while keeping in mind that there could be circumstances where an approach different from that contained in the plan is used as it would allow, for instance, reaching the resolution objectives more efficiently. Against that background, regardless of whether a group has chosen the multiple-point-of entry or the single-point-of-entry approach, all entities of the group should have at any time a robust minimum requirement for own funds and eligible liabilities so as to avoid the risk of contagion or of a bank run. (85) The best method of resolution should be chosen depending on the circumstances of the case and, for that purpose, all of the resolution tools provided for in Directive 2014/59/EU should be available. When deciding on the resolution scheme, the Board, the Council and the Commission should, to the extent possible, respectively opt for the scheme that is the least costly for the Fund. (86) Directive 2014/59/EU confers power on the national resolution authorities to write down and convert capital instruments, since the conditions for the write-down and conversion of capital instruments may coincide with the conditions for resolution and in such a case, an assessment is to be made of whether the sole write-down and conversion of the capital instruments is sufficient to restore the financial soundness of the entity concerned or whether it is also necessary to take resolution action. As a rule, it will be used in the context of resolution. The Board, under the control of the Commission or, where relevant, of the Council, should replace the national resolution authorities also in that function and should therefore be empowered to assess whether the conditions for the write-down and conversion of capital instruments are met and to decide whether to place an entity under resolution, if the requirements for resolution are also fulfilled. (87) The efficiency and uniformity of resolution action should be ensured in all of the participating Member States. For that purpose, where a national resolution authority has not applied or has not complied with a decision by the Board pursuant to this Regulation or has applied it in a way which poses a threat to any of the resolution objectives or to the efficient implementation of the resolution scheme, the Board should be empowered to transfer to another person specified rights, assets or liabilities of an institution under resolution, to require the conversion of debt instruments which contain a contractual term for conversion in certain circumstances or to adopt any necessary action which significantly addresses the threat to the relevant resolution objective. Any action by a national resolution authority that would restrain or affect the exercise of powers or functions of the Board should be excluded. (88) The relevant entities, bodies and authorities involved in the application of this Regulation should cooperate with each other in accordance with the duty of sincere cooperation enshrined in the Treaties. (89) In order to enhance the effectiveness of the SRM, the Board should closely cooperate with EBA in all circumstances. Where appropriate the Board should also cooperate with the ESRB, the European Supervisory Authority (European Insurance and Occupational Pensions Authority) (\u2018EIOPA\u2019) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (11), the European Supervisory Authority (European Securities and Markets Authority) (\u2018ESMA\u2019), established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (12), and the other authorities which constitute the ESFS. Moreover, the Board should closely cooperate with the ECB and the other authorities empowered to supervise entities within the SSM, in particular for groups subject to the consolidated supervision by the ECB. To effectively manage the resolution process of failing banks, the Board should cooperate with the national resolution authorities at all stages of the resolution process. Thus, that cooperation is necessary not only for the implementation of resolution decisions taken by the Board, but also prior to the adoption of any resolution decision, at the stage of resolution planning or during the phase of early intervention. The Board should be able to cooperate with relevant resolution authorities and facilities financing direct or indirect public financial assistance. (90) When applying resolution tools and exercising resolution powers, the Board should instruct the national resolution authorities to ensure that the representatives of the employees of the entities concerned are informed and, where appropriate, are consulted, as provided for in Directive 2014/59/EU. (91) Since the Board replaces the national resolution authorities of the participating Member States in their resolution decisions, the Board should also replace those authorities for the purposes of the cooperation with non-participating Member States, including in the resolution colleges as referred to in Directive 2014/59/EU as far as the resolution functions are concerned. (92) As many institutions operate not only within the Union, but internationally, an effective resolution mechanism needs to set out principles of cooperation with the relevant third-country authorities. Support to third-country authorities should be provided in accordance with the legal framework provided for in Article 88 of Directive 2014/59/EU. In order to ensure a coherent approach vis-\u00e0-vis third countries, the taking of divergent decisions in the participating Member States with respect to the recognition of resolution proceedings conducted in third countries in relation to institutions or parent undertakings which have subsidiaries or other assets, rights or liabilities located in the participating Member States should be avoided as far as possible. The Board should therefore be enabled to issue recommendations in that regard. (93) In order to perform its tasks effectively, the Board should have appropriate investigatory powers. It should be able to require all necessary information either through the national resolution authorities, or directly, after informing them, and to conduct investigations and on-site inspections, where appropriate in cooperation with national competent authorities, making full use of all information available to the ECB and the national competent authorities. In the context of resolution, on-site inspections should be available for the Board to ensure that decisions are taken on the basis of fully accurate information and to monitor implementation by national authorities effectively. (94) In order to ensure that the Board has access to all relevant information, the relevant entities and their employees or third parties to whom the entities concerned have outsourced functions or activities should not be able to invoke the requirements of professional secrecy to prevent the disclosure of information to the Board. At the same time, the disclosure of such information to the Board should not be deemed to infringe the requirements of professional secrecy. (95) In order to ensure compliance with decisions adopted within the framework of the SRM, proportionate and dissuasive fines should be imposed in the event of an infringement. The Board should be entitled to impose fines or periodic penalty payments on undertakings for failure to comply with its decisions addressed to them. (96) Where a national resolution authority infringes the rules of the SRM by not using the powers conferred on it under national law to implement an instruction by the Board, the Member State concerned may be liable to make good any damage caused to individuals, including, where applicable, to the institution or group under resolution, or any creditor of any part of that entity or group in any Member State, in accordance with the relevant case-law. (97) In order to guarantee its full autonomy and independence, the Board should have an autonomous budget with revenues from obligatory contributions from the institutions in the participating Member States. Appropriate rules should be laid down governing the budget of the Board, the preparation of the budget, the adoption of internal rules specifying the procedure for the establishment and implementation of the budget, and the internal and external audit of the accounts. (98) This Regulation should be without prejudice to the ability of Member States to levy fees to cover the administrative expenses of their national resolution authorities. (99) Participating Member States have jointly agreed to ensure that non-participating Member States are to be reimbursed promptly and with interest for the amount that a non-participating Member State has paid in own resources in respect of any application of the Union budget for the purposes of meeting non-contractual liabilities and costs relating thereto in relation to the performance of tasks under this Regulation. Participating Member States have concluded an agreement to implement that commitment. (100) There are circumstances in which the effectiveness of the resolution tools applied may depend on the availability of short-term funding for the entity or a bridge entity, the provision of guarantees to potential purchasers, or the provision of capital to the bridge entity. Notwithstanding the role of central banks in providing liquidity to the financial system even in times of stress, it is therefore important to set up a fund to avoid that the funds needed for such purposes come from the national budgets. It should be the financial industry, as a whole, that finances the stabilisation of the financial system. (101) It is necessary to ensure that the Fund is fully available for the purpose of the resolution of failing institutions. Therefore, the Fund should not be used for any other purpose than the efficient implementation of resolution tools and resolution powers. Furthermore, it should be used only in accordance with the applicable resolution objectives and principles. Accordingly, the Board should ensure that any losses, costs or other expenses incurred in connection with the use of the resolution tools are first borne by the shareholders and the creditors of the institution under resolution. Only where the resources from shareholders and creditors are exhausted should the losses, costs or other expenses incurred with the resolution tools be borne by the Fund. (102) As a principle, contributions should be collected from the industry prior to, and independently of, any operation of resolution. When prior funding is insufficient to cover the losses or costs incurred by the use of the Fund, additional contributions should be collected to bear the additional cost or loss. Moreover, the Fund should be able to contract borrowings or other forms of support from institutions, financial institutions or other third parties in the event that the ex-ante and ex-post contributions are not immediately accessible or do not cover the expenses incurred by the use of the Fund in relation to resolution actions. (103) In order to avoid double payments, Member States should be able to make use of available financial means resulting from national bank levies, taxes or resolution contributions established between 17 June 2010 and 2 July 2014 for the purpose of the ex-ante contributions. (104) In order to reach a critical mass and to avoid pro-cyclical effects which would arise if the Fund had to rely solely on ex-post contributions in a systemic crisis, it is indispensable that the ex-ante available financial means of the Fund amount at least to a certain minimum target level. (105) The target level of the Fund should be established as a percentage of the amount of covered deposits of all credit institutions authorised in the participating Member States. However, since the amount of the total liabilities of those institutions would be, taking into account the functions of the Fund, a more adequate benchmark, the Commission should assess whether covered deposits or total liabilities is a more appropriate basis and if a minimum absolute amount for the Fund should be introduced in the future, maintaining a level playing field with Directive 2014/59/EU. (106) An appropriate time frame should be set to reach the target level for the Fund. However, it should be possible for the Board to adjust the contribution period to take into account significant disbursements made from the Fund. (107) Ensuring effective and sufficient financing of the Fund is of paramount importance to the credibility of the SRM. The capacity of the Board to contract alternative funding means for the Fund should be enhanced in a manner that optimises the cost of funding and preserves the creditworthiness of the Fund. Immediately after the entry into force of this Regulation, the necessary steps should be taken by the Board in cooperation with the participating Member States to develop the appropriate methods and modalities permitting the enhancement of the borrowing capacity of the Fund that should be in place by the date of application of this Regulation. (108) Where participating Member States have already established national resolution financing arrangements, they should be able to provide that the national resolution financing arrangements use their available financial means, collected from entities in the past by way of ex-ante contributions, to compensate entities for the ex-ante contributions which those entities should pay into the Fund. Such restitution should be without prejudice to the obligations of Member States under Directive 2014/49/EU. (109) In order to ensure a fair calculation of contributions and provide incentives to operate under a model which presents less risk, contributions to the Fund should take account of the degree of risk incurred by the credit institution in accordance with Directive 2014/59/EU and with the delegated acts adopted pursuant thereto. (110) In order to ensure the proper sharing of resolution costs between deposit guarantee schemes and the Fund, the deposit guarantee scheme to which an institution under resolution is affiliated should be required to make a contribution not greater than the amount of losses that it would have had to bear if the entity had been wound up under normal insolvency proceedings. (111) So as to protect the value of the amounts held in the Fund, those amounts should be invested in sufficiently safe, diversified and liquid assets. (112) Where close cooperation of a participating Member State whose currency is not the euro with the ECB is terminated in accordance with Article 7 of Regulation (EU) No 1024/2013, a fair partition of the cumulated contributions of the participating Member State concerned should be decided taking into account the interests of the participating Member State concerned and the Fund. (113) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to determine the rules for the calculation of the interest rate to be applied in the event of a decision on the recovery of misused amounts from the Fund and to guarantee the rights to good administration and of access to documents of beneficiaries in procedures in respect of such a recovery; determine the type of contributions to the Fund and the matters for which contributions are due, and the manner in which the amount of the contributions is calculated and the way in which they are to be paid; specify registration, accounting, reporting and other rules necessary to ensure that the contributions are paid fully and in a timely manner; determine the annual contributions necessary to cover the administrative expenditure of the Board before it becomes fully operational; determine the contribution system for institutions that have been authorised to operate after the Fund has reached its target level; determine the criteria for the spreading out in time of the contributions; determine the criteria for determining the number of years by which the initial period for reaching the target level can be extended; determine the criteria for establishing the annual contributions when the available financial means of the Fund diminishes below its target level after the initial period; determine the measures to specify the circumstances and conditions under which ex-post contributions may be temporarily deferred for individual institutions; and determine the detailed rules for the administration of the Fund and general principles and criteria for its investment strategy. (114) The Council should, within the framework of the delegated acts adopted under Directive 2014/59/EU, adopt implementing acts to specify the application of the methodology for the calculation of individual contributions to the Fund, as well as the technical modalities for computing the flat contribution and the risk-adjusted contribution. That methodology should ensure that both the flat and the risk-adjusted elements in the formula for the calculation of individual contributions are accounted in a way that is consistent with resolution principles and in line with the delegated acts adopted pursuant to Article 103(7) of Directive 2014/59/EU. The methodology should take into account the principle of proportionality, without creating distortions between banking sector structures of the Member States. (115) As reflected in the Declaration No 39 on Article 290 of the TFEU, the Commission, in accordance with the established practice, in preparation of draft delegated acts provided for in this Regulation, should continue to consult experts appointed by the Member States. It is also of particular importance in this area that the Commission, where relevant, carry out appropriate consultations during its preparatory work with the ECB and the Board in their fields of competence. (116) Resolution actions should be properly notified and, subject to the limited exceptions laid down in this Regulation, made public. However, as information obtained by the Board, the national resolution authorities and their professional advisers during the resolution process is likely to be sensitive, before the resolution decision is made public, that information should be subject to the requirements of professional secrecy. The fact that information on the contents and details of resolution plans and the result of any assessment of those plans may have far-reaching effects, in particular on the undertakings concerned, must be taken into account. Any information provided in respect of a decision before it is taken, be it on whether the conditions for resolution are satisfied, on the use of a specific tool or of any action during the proceedings, must be presumed to have effects on the public and private interests concerned by the action. However, information that the Board and the national resolution authorities are examining a specific entity could be enough to have negative effects on that entity. It is therefore necessary to ensure that there are appropriate mechanisms for maintaining the confidentiality of such information, such as the content and details of resolution plans and the result of any assessment carried out in that context. (117) To preserve the confidentiality of the work of the Board, its members and its staff, including the staff exchanged with or seconded by participating Member States for the purpose of carrying out resolution duties, should be subject to requirements of professional secrecy, even after their duties have ceased. Those requirements should also apply to other persons authorised by the Board, to persons authorised or appointed by the national resolution authorities of the Member States to conduct on-site inspections, and to observers invited to attend the plenary and executive sessions' meetings of the Board and to observers from non-participating Member States that take part in internal resolution teams. For the purpose of performing the tasks conferred on it by this Regulation, the Board should be authorised, subject to conditions, to exchange information with national or Union authorities and bodies. (118) In order to ensure that the Board is assimilated in the ESFS, Regulation (EU) No 1093/2010 should be amended in order to include the Board in the concept of competent authorities established by that Regulation. Such assimilation of the Board and competent authorities pursuant to Regulation (EU) No 1093/2010 is consistent with the functions attributed to EBA pursuant to Article 25 of Regulation (EU) No 1093/2010 to contribute to and participate actively in the development and coordination of recovery and resolution plans and to aim to facilitate the resolution of failing entities and in particular cross-border groups. (119) Until the Board is fully operational, the Commission should be responsible for the initial operations including the designation of an interim Chair to authorise all necessary payments on behalf of the Board. (120) The SRM brings together the Board, the Council, the Commission and the resolution authorities of the participating Member States. The Court of Justice has jurisdiction to review the legality of decisions adopted by the Board, the Council and the Commission, in accordance with Article 263 TFEU, as well as for determining their non-contractual liability. Furthermore, the Court of Justice has, in accordance with Article 267 TFEU, competence to give preliminary rulings upon request of national judicial authorities on the validity and interpretation of acts of the institutions, bodies or agencies of the Union. National judicial authorities should be competent, in accordance with their national law, to review the legality of decisions adopted by the resolution authorities of the participating Member States in the exercise of the powers conferred on them by this Regulation, as well as to determine their non-contractual liability. (121) This Regulation respects the fundamental rights and observes the rights, freedoms and principles recognised in particular by the Charter, and, in particular, the right to property, the protection of personal data, the freedom to conduct a business, the right to an effective remedy and to a fair trial and the right of defence, and should be implemented in accordance with those rights and principles. (122) Since the objectives of this Regulation, namely setting up an efficient and effective single European framework for the resolution of entities and ensuring the consistent application of resolution rules, cannot be sufficiently achieved by the Member States but can rather be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (123) The Commission should review the application of this Regulation in order to assess its impact on the internal market and to determine whether any modifications or further developments are needed in order to improve the efficiency and the effectiveness of the SRM, in particular whether the banking Union needs to be completed with the harmonisation at Union level of insolvency proceedings for failed institutions. (124) The transfer of contributions raised at national level under this Regulation should allow the Fund to operate and thus the resolution tools to be applied in an effective manner. Therefore, the provisions of this Regulation relating to resolution tools and the contributions should apply from 1 January 2016. From December 2015, it should be possible to postpone that date by periods of one month where the conditions allowing the transfer of the contributions raised at national level have not been met, HAVE ADOPTED THIS REGULATION: PART I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes uniform rules and a uniform procedure for the resolution of the entities referred to in Article 2 that are established in the participating Member States referred to in Article 4. Those uniform rules and that uniform procedure shall be applied by the Single Resolution Board established in accordance with Article 42 (the \u2018Board\u2019), together with the Council and the Commission and the national resolution authorities within the framework of the single resolution mechanism (\u2018SRM\u2019) established by this Regulation. The SRM shall be supported by a single resolution fund (\u2018the Fund\u2019). The use of the Fund shall be contingent upon the entry into force of an agreement among the participating Member States (\u2018the Agreement\u2019) on transferring the funds raised at national level towards the Fund as well as on a progressive merger of the different funds raised at national level to be allocated to national compartments of the Fund. Article 2 Scope This Regulation shall apply to the following entities: (a) credit institutions established in a participating Member State; (b) parent undertakings, including financial holding companies and mixed financial holding companies, established in a participating Member State, where they are subject to consolidated supervision carried out by the ECB in accordance with Article 4(1)(g) of Regulation (EU) No 1024/2013; (c) investment firms and financial institutions established in a participating Member State, where they are covered by the consolidated supervision of the parent undertaking carried out by the ECB in accordance with Article 4(1)(g) of Regulation (EU) No 1024/2013. Article 3 Definitions 1. For the purposes of this Regulation the following definitions apply: (1) \u2018national competent authority\u2019 means any national competent authority as defined in Article 2(2) of Regulation (EU) No 1024/2013; (2) \u2018competent authority\u2019 means a competent authority as defined in Article 4(2)(i) of Regulation (EU) No 1093/2010; (3) \u2018national resolution authority\u2019 means an authority designated by a participating Member State in accordance with Article 3 of Directive 2014/59/EU; (4) \u2018relevant national resolution authority\u2019 means the national resolution authority of a participating Member State in which an entity or a group's entity is established; (5) \u2018conditions for resolution\u2019 means the conditions referred to in Article 18(1); (6) \u2018resolution plan\u2019 means a plan drawn up in accordance with Article 8 or 9; (7) \u2018group resolution plan\u2019 means a plan for group resolution drawn up in accordance with Articles 8 and 9; (8) \u2018resolution objectives\u2019 means the objectives referred to in Article 14; (9) \u2018resolution tool\u2019 means a resolution tool referred to in Article 22(2); (10) \u2018resolution action\u2019 means the decision to place an entity referred to in Article 2 under resolution pursuant to Article 18, the application of a resolution tool or the exercise of one or more resolution powers; (11) \u2018covered deposits\u2019 means deposits as defined in Article 2(1)(5) of Directive 2014/49/EU; (12) \u2018eligible deposits\u2019 means eligible deposits as defined in Article 2(1)(4) of Directive 2014/49/EU; (13) \u2018institution\u2019 means a credit institution, or an investment firm covered by consolidated supervision in accordance with Article 2(c); (14) \u2018institution under resolution\u2019 means an entity referred to in Article 2 in respect of which a resolution action is taken; (15) \u2018financial institution\u2019 means a financial institution as defined in Article 4(1)(26) of Regulation (EU) No 575/2013; (16) \u2018financial holding company\u2019 means a financial holding company as defined in Article 4(1)(20) of Regulation (EU) No 575/2013; (17) \u2018mixed financial holding company\u2019 means a mixed financial holding company as defined in point (21) of Article 4(1) of Regulation (EU) No 575/2013; (18) \u2018Union parent financial holding company\u2019 means an EU parent financial holding company as defined in point (31) of Article 4(1) of Regulation (EU) No 575/2013; (19) \u2018Union parent institution\u2019 means an EU parent institution as defined in point (29) of Article 4(1) of Regulation (EU) No 575/2013; (20) \u2018parent undertaking\u2019 means a parent undertaking as defined in Article 4(1)(15)(a) of Regulation (EU) No 575/2013; (21) \u2018subsidiary\u2019 means a subsidiary as defined in Article 4(1)(16) of Regulation (EU) No 575/2013; (22) \u2018branch\u2019 means a branch as defined in Article 4(1)(17) of Regulation (EU) No 575/2013; (23) \u2018group\u2019 means a parent undertaking and its subsidiaries that are entities as referred to in Article 2; (24) \u2018cross-border group\u2019 means a group that has entities as referred to in Article 2 established in more than one participating Member State; (25) \u2018consolidated basis\u2019 means the basis of the consolidated situation as defined in Article 4(1)(47) of Regulation (EU) No 575/2013; (26) \u2018consolidating supervisor\u2019 means consolidating supervisor as defined in Article 4(1)(41) of Regulation (EU) No 575/2013; (27) \u2018group-level resolution authority\u2019 means the resolution authority in the participating Member State in which the institution or parent undertaking subject to consolidated supervision at the highest level of consolidation within participating Member States in accordance with Article 111 of Directive 2013/36/EU is established; (28) \u2018institutional protection scheme\u2019 or \u2018IPS\u2019 means an arrangement that meets the requirements laid down in Article 113(7) of Regulation (EU) No 575/2013; (29) \u2018extraordinary public financial support\u2019 means State aid within the meaning of Article 107(1) TFEU or any other public financial support at supra-national level, which, if provided at national level, would constitute State aid, that is provided in order to preserve or restore the viability, liquidity or solvency of an entity referred to in Article 2 of this Regulation or of a group of which such an entity forms part; (30) \u2018sale of business tool\u2019 means the mechanism for effecting a transfer by a resolution authority of instruments of ownership issued by an institution under resolution, or assets, rights or liabilities of an institution under resolution, to a purchaser that is not a bridge institution, in accordance with Article 24; (31) \u2018bridge institution tool\u2019 means the mechanism for transferring instruments of ownership issued by an institution under resolution, or assets, rights or liabilities of an institution under resolution, to a bridge institution, in accordance with Article 25; (32) \u2018asset separation tool\u2019 means the mechanism for effecting a transfer of assets, rights or liabilities of an institution under resolution to an asset management vehicle in accordance with Article 26; (33) \u2018bail-in tool\u2019 means the mechanism for effecting the exercise of the write-down and conversion powers in relation to liabilities of an institution under resolution in accordance with Article 27; (34) \u2018available financial means\u2019 means the cash, deposits, assets and irrevocable payment commitments available to the Fund for the purposes listed under Article 76(1); (35) \u2018target level\u2019 means the amount of available financial means to be reached under Article 69(1); (36) \u2018Agreement\u2019 means the agreement on the transfer and mutualisation of contributions to the Fund; (37) \u2018transitional period\u2019 means the period from the date of application of this Regulation as determined under Article 99(2) and (6) until the Fund reaches the target level or 1 January 2024, whichever is earlier; (38) \u2018financial instrument\u2019 means financial instrument as defined in point (50) of Article 4(1) of Regulation (EU) No 575/2013; (39) \u2018debt instruments\u2019 means bonds and other forms of transferable debt, instruments creating or acknowledging a debt, and instruments giving rights to acquire debt instruments; (40) \u2018own funds\u2019 means own funds as defined in Article 4(1)(118) of Regulation (EU) No 575/2013; (41) \u2018own funds requirements\u2019 means the requirements laid down in Articles 92 to 98 of Regulation (EU) No 575/2013; (42) \u2018winding up\u2019 means the realisation of assets of an entity referred to in Article 2; (43) \u2018derivative\u2019 means a derivative as defined in Article 2(5) of Regulation (EU) No 648/2012; (44) \u2018write-down and conversion powers\u2019 means the powers referred to in Article 21; (45) \u2018Common Equity Tier 1 instruments\u2019 means capital instruments that meet the conditions laid down in Article 28(1) to (4), Article 29(1) to (5) or Article 31(1) of Regulation (EU) No 575/2013; (46) \u2018Additional Tier 1 instruments\u2019 means capital instruments that meet the conditions laid down in Article 52(1) of Regulation (EU) No 575/2013; (47) \u2018Tier 2 instruments\u2019 means capital instruments or subordinated loans that meet the conditions laid down in Article 63 of Regulation (EU) No 575/2013; (48) \u2018aggregate amount\u2019 means the aggregate amount by which the resolution authority has assessed that eligible liabilities are to be written down or converted, in accordance with Article 27(13); (49) \u2018eligible liabilities\u2019 means the liabilities and capital instruments that do not qualify as Common Equity Tier 1, Additional Tier 1 or Tier 2 instruments of an entity referred to in Article 2 that are not excluded from the scope of the bail-in tool pursuant to Article 27(3); (50) \u2018deposit guarantee scheme\u2019 means a deposit guarantee scheme introduced and officially recognised by a Member State pursuant to Article 4 of Directive 2014/49/EU; (51) \u2018relevant capital instruments\u2019 means Additional Tier 1 instruments and Tier 2 instruments; (52) \u2018covered bond\u2019 means an instrument as referred to in Article 52(4) of Directive 2009/65/EC of the European Parliament and of the Council (13); (53) \u2018depositor\u2019 means a depositor as defined in Article 2(1)(6) of Directive 2014/49/EU; (54) \u2018investor\u2019 means an investor within the meaning of Article 1(4) of Directive 97/9/EC of the European Parliament and of the Council (14). 2. In the absence of a relevant definition in paragraph 1 of this Article, the definitions referred to in Article 2 of Directive 2014/59/EU apply. In the absence of a relevant definition in paragraph 1 of this Article or in Article 2 of Directive 2014/59/EU, the definitions referred to in Article 3 of Directive 2013/36/EU apply. Article 4 Participating Member States 1. Participating Member States within the meaning of Article 2 of Regulation (EU) No 1024/2013 shall be considered to be participating Member States for the purposes of this Regulation. 2. Where close cooperation between a Member State and the ECB is suspended or terminated in accordance with Article 7 of Regulation (EU) No 1024/2013, entities established in that Member State shall cease to be covered by this Regulation from the date of application of the decision to suspend or terminate close cooperation. 3. In the event that the close cooperation with the ECB of a Member State whose currency is not the euro is terminated in accordance with Article 7 of Regulation (EU) No 1024/2013, the Board shall decide within three months after the date of adoption of the decision to terminate close cooperation, in agreement with that Member State, on the modalities for the recoupment of contributions that the Member State concerned has transferred to the Fund and any conditions applicable. Recoupments shall include the part of the compartment corresponding to the Member State concerned not subject to mutualisation. If during the transitional period, as laid down in the Agreement, recoupments of the non-mutualised part are not sufficient to permit the funding of the establishment by the Member State concerned of its national financial arrangement in accordance with Directive 2014/59/EU, recoupments shall also include the totality or a part of the part of the compartment corresponding to that Member State subject to mutualisation in accordance with the Agreement or otherwise, after the transitional period, the totality or a part of the contributions transferred by the Member State concerned during the close cooperation, in an amount sufficient to permit the funding of that national financial arrangement. When assessing the amount of financial means to be recouped from the mutualised part or otherwise, after the transitional period, from the Fund, the following additional criteria shall be taken into account: (a) the manner in which termination of close cooperation with the ECB has taken place, whether voluntarily, in accordance with Article 7(6) of Regulation (EU) No 1024/2013, or not; (b) the existence of ongoing resolution actions on the date of termination; (c) the economic cycle of the Member State concerned by the termination. Recoupments shall be distributed during a limited period commensurate to the duration of the close cooperation. The relevant Member State's share of the financial means from the Fund used for resolution actions during the period of close cooperation shall be deducted from those recoupments. 4. This Regulation shall continue to apply to resolution proceedings which are ongoing on the date of application of a decision as referred to in paragraph 2. Article 5 Relation to Directive 2014/59/EU and applicable national law 1. Where, pursuant to this Regulation, the Board performs tasks and exercises powers, which, pursuant to Directive 2014/59/EU are to be performed or exercised by the national resolution authority, the Board shall, for the application of this Regulation and of Directive 2014/59/EU, be considered to be the relevant national resolution authority or, in the event of cross-border group resolution, the relevant group-level resolution authority. 2. The Board, the Council and the Commission and, where relevant, the national resolution authorities, shall take decisions subject to and in compliance with the relevant Union law and in particular any legislative and non-legislative acts, including those referred to in Articles 290 and 291 TFEU. The Board, the Council and the Commission shall be subject to binding regulatory and implementing technical standards developed by EBA and adopted by the Commission in accordance with Articles 10 to 15 of Regulation (EU) No 1093/2010 and to any guidelines and recommendations issued by EBA under Article 16 of that Regulation. They shall make every effort to comply with any guidelines and recommendations of EBA which relate to tasks of a kind to be performed by those bodies. Where they do not comply or do not intend to comply with such guidelines or recommendations EBA shall be informed thereof in accordance with Article 16(3) of that Regulation. The Board, the Council and the Commission shall cooperate with EBA in the application of Articles 25 and 30 of that Regulation. The Board shall also be subject to any decisions of EBA in accordance with Article 19 of Regulation (EU) No 1093/2010 where Directive 2014/59/EU provides for such decisions. Article 6 General principles 1. No action, proposal or policy of the Board, the Council, the Commission or a national resolution authority shall discriminate against entities, deposit holders, investors or other creditors established in the Union on grounds of their nationality or place of business. 2. Every action, proposal or policy of the Board, the Council, the Commission, or of a national resolution authority in the framework of the SRM shall be undertaken with full regard and duty of care for the unity and integrity of the internal market. 3. When making decisions or taking action which may have an impact in more than one Member State, and in particular when taking decisions concerning groups established in two or more Member States, due consideration shall be given to the resolution objectives referred to in Article 14 and all of the following factors: (a) the interests of the Member States where a group operates and in particular the impact of any decision or action or inaction on the financial stability, fiscal resources, the economy, the financing arrangements, the deposit guarantee scheme or the investor compensation scheme of any of those Member States and on the Fund; (b) the objective of balancing the interests of the various Member States involved and of avoiding unfairly prejudicing or unfairly protecting the interests of a Member State; (c) the need to minimise a negative impact for any part of a group of which an entity referred to in Article 2, which is subject to a resolution, is a member. 4. When making decisions or taking actions, in particular regarding entities or groups established both in a participating Member State and in a non-participating Member State, possible negative effects on non-participating Member States, including on entities established in those Member States, shall be taken into consideration. 5. The Board, the Council and the Commission shall balance the factors referred to in paragraph 3 with the resolution objectives referred to in Article 14 as appropriate to the nature and circumstances of each case and shall comply with the decisions made by the Commission under Article 107 TFEU and Article 19 of this Regulation. 6. Decisions or actions of the Board, the Council or the Commission shall neither require Member States to provide extraordinary public financial support nor impinge on the budgetary sovereignty and fiscal responsibilities of the Member States. 7. Where the Board takes a decision that is addressed to a national resolution authority, the national resolution authority shall have the right to specify further the measures to be taken. Such specifications shall comply with the decision of the Board in question. Article 7 Division of tasks within the SRM 1. The Board shall be responsible for the effective and consistent functioning of the SRM. 2. Subject to the provisions referred to in Article 31(1), the Board shall be responsible for drawing up the resolution plans and adopting all decisions relating to resolution for: (a) the entities referred to in Article 2 that are not part of a group and for groups: (i) which are considered to be significant in accordance with Article 6(4) of Regulation (EU) No 1024/2013; or (ii) in relation to which the ECB has decided in accordance with Article 6(5)(b) of Regulation (EU) No 1024/2013 to exercise directly all of the relevant powers; and (b) other cross-border groups. 3. In relation to entities and groups other than those referred to in paragraph 2, without prejudice to the responsibilities of the Board for the tasks conferred on it by this Regulation, the national resolution authorities shall perform, and be responsible for, the following tasks: (a) adopting resolution plans and carrying out an assessment of resolvability in accordance with Articles 8 and 10 and with the procedure laid down in Article 9; (b) adopting measures during early intervention in accordance with Article 13(3); (c) applying simplified obligations or waiving the obligation to draft a resolution plan, in accordance with Article 11; (d) setting the level of minimum requirement for own funds and eligible liabilities, in accordance with Article 12; (e) adopting resolution decisions and applying resolution tools referred to in this Regulation, in accordance with the relevant procedures and safeguards, provided that the resolution action does not require any use of the Fund and is financed exclusively by the tools referred to in Articles 21 and 24 to 27 and/or by the deposit guarantee scheme, in accordance with Article 79, and with the procedure laid down in Article 31; (f) writing down or converting relevant capital instruments pursuant to Article 21, in accordance with the procedure laid down in Article 31. If the resolution action requires the use of the Fund, the Board shall adopt the resolution scheme. When adopting a resolution decision, the national resolution authorities shall take into account and follow the resolution plan as referred to in Article 9, unless they assess, taking into account the circumstances of the case, that the resolution objectives will be achieved more effectively by taking actions which are not provided for in the resolution plan. When performing the tasks referred to in this paragraph, the national resolution authorities shall apply the relevant provisions of this Regulation. Any references to the Board in Article 5(2), Article 6(5), Article 8(6), (8), (12) and (13), Article 10(1) to (10), Articles 11 to 14, Article 15(1), (2) and (3), Article 16, the first subparagraph of Article 18(1), Article 18(2) and (6), Article 20, Article 21(1) to (7), the second subparagraph of Article 21(8), Article 21(9) and (10), Article 22(1), (3) and (6), Articles 23 and 24, Article 25(3), Article 27(1) to (15), the second sentence of the second subparagraph, the third subparagraph, and the first, third and fourth sentences of the fourth subparagraph of Article 27(16), and Article 32 shall be read as references to the national resolution authorities with regard to groups and entities referred to in the first subparagraph of this paragraph. For that purpose the national resolution authorities shall exercise the powers conferred on them under national law transposing Directive 2014/59/EU in accordance with the conditions laid down in national law. The national resolution authorities shall inform the Board of the measures referred to in this paragraph that are to be taken and shall closely coordinate with the Board when taking those measures. The national resolution authorities shall submit to the Board the resolution plans referred to in Article 9, as well as any updates, accompanied by a reasoned assessment of the resolvability of the entity or group concerned in accordance with Article 10. 4. Where necessary to ensure the consistent application of high resolution standards under this Regulation, the Board may: (a) further to the notification by a national resolution authority of a measure under paragraph 3 of this Article pursuant to Article 31(1), within the appropriate timeframe having regard to the urgency of the circumstances, issue a warning to the relevant national resolution authority where the Board considers that the draft decision with regard to any entity or group referred to in paragraph 3 of this Article does not comply with this Regulation or with its general instructions referred to in Article 31(1)(a); (b) at any time decide, in particular if its warning referred to in point (a) is not being appropriately addressed, on its own initiative, after consulting the national resolution authority concerned, or upon request from the national resolution authority concerned, to exercise directly all of the relevant powers under this Regulation also with regard to any entity or group referred to in paragraph 3 of this Article. 5. Notwithstanding paragraph 3 of this Article, participating Member States may decide that the Board exercise all of the relevant powers and responsibilities conferred on it by this Regulation in relation to entities and to groups, other than those referred to in paragraph 2, established in their territory. If so, paragraphs 3 and 4 of this Article, Article 9, Article 12(2), and Article 31(1) shall not apply. Member States that intend to make use of this option shall notify the Board and the Commission accordingly. The notification shall take effect from the day of its publication in the Official Journal of the European Union. PART II SPECIFIC PROVISIONS TITLE I FUNCTIONS WITHIN THE SRM AND PROCEDURAL RULES CHAPTER 1 Resolution planning Article 8 Resolution plans drawn up by the Board 1. The Board shall draw up and adopt resolution plans for the entities and groups referred to in Article 7(2), and for the entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met. 2. The Board shall draw up the resolution plans, after consulting the ECB or the relevant national competent authorities and the national resolution authorities, including the group-level resolution authority, of the participating Member States in which the entities are established, and the resolution authorities of non-participating Member States in which significant branches are located insofar as relevant to the significant branch. To that end, the Board may require the national resolution authorities to prepare and submit to the Board draft resolution plans and the group-level resolution authority to prepare and submit to the Board a draft group resolution plan. 3. In order to ensure effective and consistent application of this Article, the Board shall issue guidelines and address instructions to the national resolution authorities for the preparation of draft resolution plans and draft group resolution plans relating to specific entities or groups. 4. For the purposes of paragraph 1 of this Article, the national resolution authorities shall submit to the Board all information necessary to draw up and implement the resolution plans, as obtained by them in accordance with Article 11 and Article 13(1) of Directive 2014/59/EU, without prejudice to Chapter 5 of this Title. 5. The resolution plan shall set out options for applying the resolution tools and exercising resolution powers referred to in this Regulation to the entities and groups referred to in paragraph 1. 6. The resolution plan shall provide for the resolution actions which the Board may take where an entity or a group referred to in paragraph 1 meets the conditions for resolution. The information referred to in paragraph 9 shall be disclosed to the entity concerned. When drawing up and updating the resolution plan, the Board shall identify any material impediments to resolvability and, where necessary and proportionate, outline relevant actions for how those impediments could be addressed, in accordance with Article 10. The resolution plan shall take into consideration relevant scenarios including that the event of failure may be idiosyncratic or may occur at a time of broader financial instability or system wide events. The resolution plan shall not assume any of the following: (a) any extraordinary public financial support besides the use of the Fund established in accordance with Article 67; (b) any central bank emergency liquidity assistance; or (c) any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. 7. The resolution plan shall include an analysis of how and when an institution may apply, in the conditions addressed by the plan, for the use of central bank facilities and shall identify those assets which would be expected to qualify as collateral. 8. The Board may require institutions to assist it in the drawing up and updating of the plans. 9. The resolution plan for each entity shall include, quantified where appropriate and possible: (a) a summary of the key elements of the plan; (b) a summary of the material changes to the institution that have occurred after the latest resolution information was filed; (c) a demonstration of how critical functions and core business lines could be legally and economically separated, to the extent necessary, from other functions so as to ensure continuity upon the failure of the institution; (d) an estimation of the timeframe for executing each material aspect of the plan; (e) a detailed description of the assessment of resolvability carried out in accordance with Article 10; (f) a description of any measures required pursuant to Article 10(7) to address or remove impediments to resolvability identified as a result of the assessment carried out in accordance with Article 10; (g) a description of the processes for determining the value and marketability of the critical functions, core business lines and assets of the institution; (h) a detailed description of the arrangements for ensuring that the information required pursuant to Article 11 of Directive 2014/59/EU is up to date and at the disposal of the resolution authorities at all times; (i) an explanation as to how the resolution options could be financed without the assumption of any of the following: (i) any extraordinary public financial support besides the use of the Fund established in accordance with Article 67; (ii) any central bank emergency liquidity assistance; or (iii) any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms; (j) a detailed description of the different resolution strategies that could be applied according to the different possible scenarios and the applicable timescales; (k) a description of critical interdependencies; (l) a description of options for preserving access to payments and clearing services and other infrastructures and an assessment of the portability of client positions; (m) an analysis of the impact of the plan on the employees of the institution, including an assessment of any associated costs, and a description of envisaged procedures to consult staff during the resolution process, taking into account national systems for dialogue with social partners, where applicable; (n) a plan for communicating with the media and the public; (o) the minimum requirement for own funds and eligible liabilities required pursuant to Article 12 and a deadline to reach that level, where applicable; (p) where applicable, the minimum requirement for own funds and contractual bail-in instruments pursuant to Article 12, and a deadline to reach that level, where applicable; (q) a description of essential operations and systems for maintaining the continuous functioning of the institution's operational processes; (r) where applicable, any opinion expressed by the institution in relation to the resolution plan. 10. Group resolution plans shall include a plan for the resolution of the group, headed by the Union parent undertaking established in a participating Member State, as a whole, either through resolution at the level of the Union parent undertaking or through break up and resolution of the subsidiaries. The group resolution plan shall identify measures for the resolution of: (a) the Union parent undertaking; (b) the subsidiaries that are part of the group and that are established in the Union; (c) the entities referred to in Article 2(b); and (d) subject to Article 33, the subsidiaries that are part of the group and that are established outside the Union. 11. The group resolution plan shall: (a) set out the resolution actions to be taken in relation to group entities, both through resolution actions in respect of the entities referred to in Article 2(b) and subsidiary institutions and through coordinated resolution actions in respect of subsidiary institutions, in the scenarios provided for in paragraph 6; (b) examine the extent to which the resolution tools and powers could be applied and exercised in a coordinated way to group entities established in the Union, including measures to facilitate the purchase by a third party of the group as a whole, or separate business lines or activities that are delivered by a number of group entities, or particular group entities, and identify any potential impediments to a coordinated resolution; (c) include a detailed description of the assessment of resolvability carried out in accordance with Article 10; (d) where a group includes entities incorporated in third countries, identify appropriate arrangements for cooperation and coordination with the relevant authorities of those third countries and the implications for resolution within the Union; (e) identify measures, including the legal and economic separation of particular functions or business lines, that are necessary to facilitate group resolution where the conditions for resolution are met; (f) identify how the group resolution actions could be financed and, where the Fund and the financing arrangements from non-participating Member States established in accordance with Article 100 of Directive 2014/59/EU would be required, set out principles for sharing responsibility for that financing between sources of funding in different participating and non-participating Member States. The plan shall not assume any of the following: (i) any extraordinary public financial support besides the use of the Fund established in accordance with Article 67 of this Regulation and the financing arrangements from non-participating Member States established in accordance with Article 100 of Directive 2014/59/EU; (ii) any central bank emergency liquidity assistance; or (iii) any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. Those principles shall be set out on the basis of equitable and balanced criteria and shall take into account in particular Article 107(5) of Directive 2014/59/EU and the impact on financial stability in all Member States concerned. The group resolution plan shall not have a disproportionate impact on any Member State. 12. The Board shall determine the date by which the first resolution plans shall be drawn up. Resolution plans and group resolution plans shall be reviewed, and where appropriate updated, at least annually and after any material changes to the legal or organisational structure or to the business or the financial position of the entity or, in the case of group resolution plans, of the group including any group entity that could have a material effect on the effectiveness of the plan or that otherwise necessitates a revision of the resolution plan. For the purpose of the revision or update of the resolution plans referred to in the first subparagraph, the institutions, the ECB or the national competent authorities shall promptly communicate to the Board any change that necessitates such revision or update. 13. The Board shall transmit the resolution plans and any changes thereto to the ECB or to the relevant national competent authorities. Article 9 Resolution plans drawn up by national resolution authorities 1. The national resolution authorities shall draw up and adopt resolution plans for the entities and for the groups, other than those referred to in Article 7(2), (4)(b) and (5), in accordance with Article 8(5) to (13). 2. The national resolution authorities shall prepare resolution plans, after consulting the relevant national competent authorities and the national resolution authorities of the participating and non-participating Member States, in which significant branches are located, insofar as relevant to the significant branch. Article 10 Assessment of resolvability 1. When drafting and updating resolution plans in accordance with Article 8, the Board, after consulting the competent authorities, including the ECB, and the resolution authorities of non-participating Member States in which significant branches are located insofar as relevant to the significant branch, shall conduct an assessment of the extent to which institutions and groups are resolvable without the assumption of any of the following: (a) any extraordinary public financial support besides the use of the Fund established in accordance with Article 67; (b) any central bank emergency liquidity assistance; or (c) any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. 2. The ECB or the relevant national competent authority shall provide the Board with a recovery plan or group recovery plan. The Board shall examine the recovery plan with a view to identifying any actions in the recovery plan which may adversely impact the resolvability of the institution or group and make recommendations to the ECB or the national competent authority on those matters. 3. When drafting a resolution plan, the Board shall assess the extent to which such an entity is resolvable in accordance with this Regulation. An entity shall be deemed to be resolvable if it is feasible and credible for the Board to either liquidate it under normal insolvency proceedings or to resolve it by applying to it resolution tools and exercising resolution powers while avoiding, to the maximum extent possible, any significant adverse consequences for financial systems, including circumstances of broader financial instability or system wide events, of the Member State in which the entity is situated, or other Member States, or the Union and with a view to ensuring the continuity of critical functions carried out by the entity. The Board shall notify EBA in a timely manner where an institution is deemed not to be resolvable. 4. A group shall be deemed to be resolvable if it is feasible and credible for the Board to either liquidate group entities under normal insolvency proceedings or to resolve them by applying resolution tools and exercising resolution powers in relation to group entities while avoiding, to the maximum extent possible, any significant adverse consequences for financial systems, including circumstances of broader financial instability or system wide events, of the Member States in which group entities are established, or other Member States or the Union and with a view to ensuring the continuity of critical functions carried out by those group entities, where they can be easily separated in a timely manner or by other means. The Board shall notify EBA in a timely manner where a group is deemed not to be resolvable. 5. For the purposes of paragraphs 3, 4 and 10, significant adverse consequences for the financial system or threat to financial stability refers to a situation where the financial system is actually or potentially exposed to a disruption that may give rise to financial distress liable to jeopardise the orderly functioning, efficiency and integrity of the internal market or the economy or the financial system of one or more Member States. In determining the significant adverse consequences the Board shall take into account the relevant warnings and recommendations of the ESRB and the relevant criteria developed by EBA in considering the identification and measurement of systemic risk. 6. For the purpose of the assessment referred to in this Article, the Board shall examine the matters specified in Section C of the Annex to Directive 2014/59/EU. 7. If, pursuant to an assessment of resolvability for an entity or a group carried out in accordance with paragraph 3 or 4, the Board, after consulting the competent authorities, including the ECB, determines that there are substantive impediments to the resolvability of that entity or group, the Board shall prepare a report, in cooperation with the competent authorities, addressed to the institution or the parent undertaking analysing the substantive impediments to the effective application of resolution tools and the exercise of resolution powers. That report shall consider the impact on the institution's business model and recommend any proportionate and targeted measures that, in the Board's view, are necessary or appropriate to remove those impediments in accordance with paragraph 10. 8. The report shall also be notified to the competent authorities and to the resolution authorities of non-participating Member States in which significant branches of institutions which are not part of a group are located. It shall be supported by reasons for the assessment or determination in question and shall indicate how that assessment or determination complies with the requirement for proportionate application laid down in Article 6. 9. Within four months from the date of receipt of the report, the entity or the parent undertaking shall propose to the Board possible measures to address or remove the substantive impediments identified in the report. The Board shall communicate any measure proposed by the entity or parent undertaking to the competent authorities, to EBA and, where significant branches of institutions that are not part of a group are located in non-participating Member States, to the resolution authorities of those Member States. 10. The Board, after consulting the competent authorities, shall assess whether the measures referred to in paragraph 9 effectively address or remove the substantive impediments in question. If the measures proposed by the entity or parent undertaking concerned do not effectively reduce or remove the impediments to resolvability, the Board shall take a decision, after consulting the competent authorities and, where appropriate, the designated macro-prudential authority, indicating that the measures proposed do not effectively reduce or remove the impediments to resolvability, and instructing the national resolution authorities to require the institution, the parent undertaking, or any subsidiary of the group concerned, to take any of the measures listed in paragraph 11. In identifying alternative measures, the Board shall demonstrate how the measures proposed by the institution would not be able to remove the impediments to resolvability and how the alternative measures proposed are proportionate in removing them. The Board shall take into account the threat to financial stability of those impediments to resolvability and the effect of the measures on the business of the institution, its stability and its ability to contribute to the economy, on the internal market for financial services and on the financial stability in other Member States and the Union as a whole. The Board shall also take into account the need to avoid any impact on the institution or the group concerned which would go beyond what is necessary to remove the impediment to resolvability or would be disproportionate. 11. For the purpose of paragraph 10, the Board, where applicable, shall instruct the national resolution authorities to take any of the following measures: (a) to require the entity to revise any intragroup financing agreements or review the absence thereof, or draw up service agreements (whether intra-group or with third parties) to cover the provision of critical functions; (b) to require the entity to limit its maximum individual and aggregate exposures; (c) to impose specific or regular additional information requirements relevant for resolution purposes; (d) to require the entity to divest specific assets; (e) to require the entity to limit or cease specific existing or proposed activities; (f) to restrict or prevent the development of new or existing business lines or sale of new or existing products; (g) to require changes to legal or operational structures of the entity or any group entity, either directly or indirectly under their control, so as to reduce complexity in order to ensure that critical functions may be legally and operationally separated from other functions through the application of the resolution tools; (h) to require an entity to set up a parent financial holding company in a Member State or a Union parent financial holding company; (i) to require an entity to issue eligible liabilities to meet the requirements of Article 12; (j) to require an entity to take other steps to meet the requirements referred to in Article 12, including in particular to attempt to renegotiate any eligible liability, Additional Tier 1 instrument or Tier 2 instrument it has issued, with a view to ensuring that any decision of the Board to write down or convert that liability or instrument would be effected under the law of the jurisdiction governing that liability or instrument. Where applicable, the national resolution authorities shall directly take the measures referred to in points (a) to (j) of the first subparagraph. 12. The national resolution authorities shall implement the instructions of the Board in accordance with Article 29. 13. A decision made pursuant to paragraphs 10 and 11 shall meet the following requirements: (a) it shall be supported by reasons for the assessment or determination in question; (b) it shall indicate how that assessment or determination complies with the requirement for proportionate application laid down in paragraph 10. Article 11 Simplified obligations for certain institutions 1. The Board, on its own initiative after consulting a national resolution authority or upon proposal by a national resolution authority, may apply simplified obligations in relation to the drafting of resolution plans referred to in Article 8 or may waive the obligation of drafting those plans in accordance with paragraphs 3 to 9 of this Article. 2. National resolution authorities may propose to the Board to apply simplified obligations to institutions or groups pursuant to paragraphs 3 and 4 or to waive the obligation of drafting resolution plans pursuant to paragraph 7. That proposal shall be reasoned and shall be supported by all of the relevant documentation. 3. On receiving a proposal to apply simplified obligations pursuant to paragraph 2 of this Article, or when acting on its own initiative, the Board shall conduct an assessment of the institution or group concerned and shall apply simplified obligations, if the failure of the institution or group is not likely to have significant adverse consequences for the financial system or be a threat to financial stability within the meaning of Article 10(5). For those purposes, the Board shall take into account: (a) the nature of the institution's or group's business, its shareholding structure, its legal form, its risk profile, size and legal status, its interconnectedness to other institutions or to the financial system in general, the scope and complexity of its activities; (b) its membership of an IPS or other cooperative mutual solidarity systems as referred to in Article 113(7) of Regulation (EU) No 575/2013; (c) any exercise of investment services or activities as defined in Article 4(1)(2) of Directive 2014/65/EU of the European Parliament and of the Council (15); and (d) whether its failure and subsequent winding up under normal insolvency proceedings would be likely to have a significant negative effect on financial markets, on other institutions, on funding conditions, or on the wider economy. The Board shall make the assessment referred to in the first subparagraph after consulting, where appropriate, the national macroprudential authority and, where appropriate, the ESRB. 4. When applying simplified obligations, the Board shall determine: (a) the contents and details of resolution plans provided for in Article 8; (b) the date by which the first resolution plans are to be drawn up and the frequency for updating resolution plans which may be lower than that provided for in Article 8(12); (c) the contents and details of the information required from institutions as provided for in Article 8(9) of this Regulation and in Section B of the Annex to Directive 2014/59/EU; (d) the level of detail for the assessment of resolvability provided for in Article 10 of this Regulation, and in Section C of the Annex to Directive 2014/59/EU. 5. The application of simplified obligations shall not in itself affect the Board's power to take any resolution action. 6. Where simplified obligations are applied, the Board shall impose full, unsimplified obligations at any time if any of the circumstances that justified them no longer exist. 7. Without prejudice to Articles 9 and 31, on receiving a proposal to waive the obligation of drafting resolution plans pursuant to paragraph 2 of this Article, or when acting on its own initiative, the Board shall, pursuant to paragraph 3 of this Article, waive the application of the obligation of drafting resolution plans to institutions affiliated to a central body and wholly or partially exempt from prudential requirements in national law in accordance with Article 10 of Regulation (EU) No 575/2013. Where a waiver is granted in accordance with the first subparagraph, the obligation of drafting the resolution plan shall apply on a consolidated basis to the central body and institutions affiliated to it within the meaning of Article 10 of Regulation (EU) No 575/2013. For that purpose, any reference in this Chapter to a group shall include a central body and institutions affiliated to it within the meaning of Article 10 of Regulation (EU) No 575/2013 and their subsidiaries, and any reference to parent undertakings or institutions that are subject to consolidated supervision pursuant to Article 111 of Directive 2013/36/EU shall include the central body. 8. Institutions that are subject to direct supervision by the ECB pursuant to Article 6(4) of Regulation (EU) No 1024/2013 or that constitute a significant share in the financial system of a participating Member State shall be the subject of individual resolution plans. For the purposes of this paragraph, the operations of an institution shall be considered to constitute a significant share of that participating Member State's financial system where: (a) the total value of its assets exceeds EUR 30 000 000 000; or (b) the ratio of its total assets over the GDP of the Member State of establishment exceeds 20 %, unless the total value of its assets is below EUR 5 000 000 000. 9. Where the national resolution authority which has proposed the application of simplified obligations or the grant of a waiver in accordance with paragraph 2 considers that the decision to apply simplified obligations or to grant the waiver must be withdrawn, it shall submit a proposal to the Board to that end. In that case, the Board shall take a decision on the proposed withdrawal taking full account of the justification for withdrawal put forward by the national resolution authority in the light of the factors or circumstances referred to in paragraph 3 or in paragraphs 7 and 8. 10. The Board shall inform EBA of its application of this Article. Article 12 Minimum requirement for own funds and eligible liabilities 1. The Board shall, after consulting competent authorities, including the ECB, determine the minimum requirement for own funds and eligible liabilities as referred to in paragraph 4, subject to write-down and conversion powers, which the entities and groups referred to in Article 7(2), and the entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of these paragraphs are met, are required to meet at all times. 2. When drafting resolution plans in accordance with Article 9, national resolution authorities shall, after consulting competent authorities, determine the minimum requirement for own funds and eligible liabilities, as referred to in paragraph 4, subject to write-down and conversion powers, which the entities referred to in Article 7(3) are required to meet at all times. In that regard the procedure established in Article 31 shall apply. 3. In order to ensure effective and consistent application of this Article, the Board shall issue guidelines and address instructions to national resolution authorities relating to specific entities or groups. 4. The minimum requirement for own funds and eligible liabilities shall be calculated as the amount of own funds and eligible liabilities expressed as a percentage of the total liabilities and own funds of the institution. For the purpose of the first subparagraph derivative liabilities shall be included in the total liabilities on the basis that full recognition is given to counterparty netting rights. 5. Notwithstanding paragraph 1, the Board shall exempt mortgage credit institutions financed by covered bonds which, according to national law, are not allowed to receive deposits, from the obligation to meet, at all times, a minimum requirement for own funds and eligible liabilities, as: (a) those institutions will be wound up through national insolvency procedures, or other type of procedures implemented in accordance with Article 38, 40 or 42 of Directive 2014/59/EU, provided for those institutions; and (b) such national insolvency procedures, or other type of procedures, will ensure that creditors of those institutions, including holders of covered bonds where relevant, will bear losses in a way that meets the resolution objectives. 6. The minimum requirement for own funds and eligible liabilities referred to in paragraph 4 shall not exceed the amount of own funds and eligible liabilities sufficient to ensure that, if the bail-in tool were to be applied, the losses of an institution or a parent undertaking as referred to in Article 2, as well as of the ultimate parent undertaking of that institution or parent undertaking and any institution or financial institution included in the consolidated accounts of that ultimate parent undertaking, could be absorbed, and the Common Equity Tier 1 ratio of those entities could be restored to a level necessary to enable them to continue to comply with the conditions for authorisation and to continue to carry out the activities for which they are authorised under Directive 2013/36/EU or equivalent legislation and to sustain sufficient market confidence in the institution or parent undertaking referred to in Article 2 and the ultimate parent undertaking of that institution or parent undertaking and any institution or financial institution included in the consolidated accounts of that ultimate parent undertaking. Where the resolution plan anticipates that certain classes of eligible liabilities might be excluded from bail-in under Article 27(5), or that certain classes of eligible liabilities might be transferred to a recipient in full under a partial transfer, the minimum requirement for own funds and eligible liabilities referred to in paragraph 4 shall not exceed the amount of own funds and eligible liabilities necessary to ensure that the institution or parent undertaking referred to in Article 2 has sufficient other eligible liabilities to ensure that losses of the institution or the parent undertaking referred to in Article 2 as well as of the ultimate parent undertaking of that institution or parent undertaking and any institution or financial institution included in the consolidated accounts of that ultimate parent undertaking could be absorbed and the Common Equity Tier 1 ratio of those entities could be restored to a level necessary to enable them to continue to comply with the conditions for authorisation and to carry out the activities for which they are authorised under Directive 2013/36/EU or equivalent legislation and to sustain sufficient market confidence in the institution or parent undertaking and the ultimate parent undertaking of that institution or parent undertaking and any institution or financial institution included in the consolidated accounts of that ultimate parent undertaking. The minimum requirement for own funds and eligible liabilities referred to in paragraph 4 shall not be inferior to the total amount of any own funds requirements and buffer requirements under Regulation (EU) No 575/2013 and Directive 2013/36/EU. 7. Within the limits laid down in paragraph 6 of this Article, in order to ensure that an entity referred to in Article 2 can be resolved by the application of the resolution tools including, where appropriate, the bail-in tool, in a way that meets the resolution objectives, the determination referred to in paragraph 1 of this Article shall be made on the basis of the following criteria: (a) the size, the business model, the funding model and the risk profile of the institution and parent undertaking referred to in Article 2; (b) the extent to which the deposit guarantee scheme could contribute to the financing of resolution in accordance with Article 79; (c) the extent to which the failure of the institution and parent undertaking referred to in Article 2 would have significant adverse consequences for the financial system or would be a threat to financial stability within the meaning of Article 10(5), including, due to its interconnectedness with other institutions or with the rest of the financial system through contagion to other institutions. 8. The determination shall specify the minimum requirement for own funds and eligible liabilities that the institutions are to comply with on an individual basis, and that parent undertakings are to comply with on a consolidated basis. The minimum aggregate amount requirement for own funds and eligible liabilities at consolidated level of a Union parent undertaking established in a participating Member State shall be determined by the Board, after consulting the consolidating supervisor, on the basis of the criteria laid down in paragraph 7, and of whether the third-country subsidiaries of the group are to be resolved separately in accordance with the resolution plan. 9. The Board shall set the minimum requirement for own funds and eligible liabilities to be applied to the group's subsidiaries on an individual basis. Those minimum requirements for own funds and eligible liabilities shall be set at a level appropriate for the subsidiary having regard to: (a) the criteria listed in paragraph 7, in particular the size, business model and risk profile of the subsidiary, including its own funds; and (b) the consolidated requirement that has been set for the group. 10. The Board may decide to waive the minimum requirement for own funds and eligible liabilities on an individual basis to a parent institution provided that the conditions laid down in points (a) and (b) of Article 45(11) of Directive 2014/59/EU are met. The Board may decide to waive the minimum requirement for own funds and eligible liabilities on an individual basis to a subsidiary provided that the conditions laid down in points (a), (b) and (c) of Article 45(12) of Directive 2014/59/EU are met. 11. The Board, on its own initiative after consulting the national resolution authority or upon proposal by a national resolution authority, may decide that the minimum requirement for own funds and eligible liabilities as referred to in paragraph 1 is partially met on a consolidated or on an individual basis through contractual bail-in instruments, in full compliance with the criteria laid down in the first and second subparagraphs of paragraph 5 and in paragraph 7. 12. To qualify as a contractual bail-in instrument under paragraph 11, the Board must be satisfied that the instrument: (a) contains a contractual term providing that, where the Board decides that the bail-in tool be applied to that institution, the instrument shall be written down or converted to the extent required before other eligible liabilities are written down or converted; and (b) is subject to a binding subordination agreement, undertaking or provision under which in the event of normal insolvency proceedings, it ranks below other eligible liabilities and cannot be repaid until other eligible liabilities outstanding at the time have been settled. 13. The Board shall make any determination referred to in paragraph 1 of this Article, and, where relevant, in paragraph 11 of this Article, in parallel with the development and maintenance of the resolution plans pursuant to Article 8. 14. The Board shall address its determination to the national resolution authorities. The national resolution authorities shall implement the instructions of the Board in accordance with Article 29. The Board shall require that the national resolution authorities verify and ensure that institutions and parent undertakings maintain the minimum requirement for own funds and eligible liabilities laid down in paragraph 1 of this Article. 15. The Board shall inform the ECB and EBA of the minimum requirement for own funds and eligible liabilities that it has determined for each institution and parent undertaking under paragraph 1 and, where relevant, the requirements laid down in paragraph 11. 16. Eligible liabilities, including subordinated debt instruments and subordinated loans that do not qualify as Additional Tier 1 instruments or Tier 2 instruments, shall be included in the amount of own funds and eligible liabilities referred to in paragraph 1 only if they satisfy the following conditions: (a) the instrument is issued and fully paid up; (b) the liability is not owed to, secured by or guaranteed by the institution itself; (c) the purchase of the instrument was not funded either directly or indirectly by the institution; (d) the liability has a remaining maturity of at least one year; (e) the liability does not arise from a derivative; (f) the liability does not arise from a deposit which benefits from preference in the national insolvency hierarchy in accordance with Article 108 of Directive 2014/59/EU. For the purpose of point (d) of the first subparagraph, where a liability confers upon its owner a right to early reimbursement, the maturity of that liability shall be the first date where such right arises. 17. Where a liability is governed by the law of a jurisdiction outside the Union, the Board may instruct national resolution authorities to require the institution to demonstrate that any decision of the Board to write down or convert that liability would be effected under the law of that jurisdiction, having regard to the terms of the contract governing the liability, international agreements on the recognition of resolution proceedings and other relevant matters. If the Board is not satisfied that any decision would be effected under the law of that jurisdiction, the liability shall not be counted towards the minimum requirement for own funds and eligible liabilities. 18. If the Commission submits a legislative proposal pursuant to Article 45(18) of Directive 2014/59/EU, it shall, if appropriate, submit a legislative proposal amending this Regulation in the same way. CHAPTER 2 Early intervention Article 13 Early intervention 1. The ECB or national competent authorities shall inform the Board of any measure that they require an institution or group to take or that they take themselves pursuant to Article 16 of Regulation (EU) No 1024/2013, to Article 27(1) or Article 28 or 29 of Directive 2014/59/EU, or to Article 104 of Directive 2013/36/EU. The Board shall notify the Commission of any information which it has received pursuant to the first subparagraph. 2. From the date of receipt of the information referred to in paragraph 1, and without prejudice to the powers of the ECB and national competent authorities in accordance with other Union law, the Board may prepare for the resolution of the institution or group concerned. For the purposes of the first subparagraph, the ECB or the relevant national competent authority shall closely monitor, in cooperation with the Board, the conditions of the institution or the parent undertaking and their compliance with any early intervention measure that was required of them. The ECB or the relevant national competent authority shall provide the Board with all of the information necessary in order to update the resolution plan and prepare for the possible resolution of the institution and for valuation of the assets and liabilities of the institution in accordance with Article 20(1) to (15). 3. The Board shall have the power to require the institution, or the parent undertaking, to contact potential purchasers in order to prepare for the resolution of the institution, subject to the criteria specified in Article 39(2) of Directive 2014/59/EU and the requirements of professional secrecy laid down in Article 88 of this Regulation. The Board shall also have the power to require the relevant national resolution authority to draft a preliminary resolution scheme for the institution or group concerned. The Board shall inform the ECB, the relevant national competent authorities and the relevant national resolution authorities of any action it takes pursuant to this paragraph. 4. If the ECB or the national competent authorities intend to impose on an institution or a group any additional measure under Article 16 of Regulation (EU) No 1024/2013, under Article 27(1), 28 or 29 of Directive 2014/59/EU or under Article 104 of Directive 2013/36/EU, before the entity or group has fully complied with the first measure notified to the Board, they shall inform the Board before imposing such additional measure on the institution or group concerned. 5. The ECB or the national competent authority, the Board and the relevant national resolution authorities shall ensure that the additional measure referred to in paragraph 4 and any action of the Board aimed at preparing for resolution under paragraph 2 are consistent. CHAPTER 3 Resolution Article 14 Resolution objectives 1. When acting under the resolution procedure referred to in Article 18, the Board, the Council, the Commission, and, where relevant, the national resolution authorities, in respect of their respective responsibilities, shall take into account the resolution objectives, and choose the resolution tools and resolution powers which, in their view, best achieve the resolution objectives that are relevant in the circumstances of the case. 2. The resolution objectives referred to in paragraph 1 are the following: (a) to ensure the continuity of critical functions; (b) to avoid significant adverse effects on financial stability, in particular by preventing contagion, including to market infrastructures, and by maintaining market discipline; (c) to protect public funds by minimising reliance on extraordinary public financial support; (d) to protect depositors covered by Directive 2014/49/EU and investors covered by Directive 97/9/EC; (e) to protect client funds and client assets. When pursuing the objectives referred to in the first subparagraph, the Board, the Council, the Commission and, where relevant, the national resolution authorities, shall seek to minimise the cost of resolution and avoid destruction of value unless necessary to achieve the resolution objectives. 3. Subject to different provisions of this Regulation, the resolution objectives are of equal significance, and shall be balanced, as appropriate, to the nature and circumstances of each case. Article 15 General principles governing resolution 1. When acting under the resolution procedure referred to in Article 18, the Board, the Council, the Commission and, where relevant, the national resolution authorities, shall take all appropriate measures to ensure that the resolution action is taken in accordance with the following principles: (a) the shareholders of the institution under resolution bear first losses; (b) creditors of the institution under resolution bear losses after the shareholders in accordance with the order of priority of their claims pursuant to Article 17, save as expressly provided otherwise in this Regulation; (c) the management body and senior management of the institution under resolution are replaced, except in those cases where the retention of the management body and senior management, in whole or in part, as appropriate to the circumstances, is considered to be necessary for the achievement of the resolution objectives; (d) the management body and senior management of the institution under resolution shall provide all necessary assistance for the achievement of the resolution objectives; (e) natural and legal persons are made liable, subject to national law, under civil or criminal law, for their responsibility for the failure of the institution under resolution; (f) except where otherwise provided in this Regulation, creditors of the same class are treated in an equitable manner; (g) no creditor shall incur greater losses than would have been incurred if an entity referred to in Article 2 had been wound up under normal insolvency proceedings in accordance with the safeguards provided for in Article 29; (h) covered deposits are fully protected; and (i) resolution action is taken in accordance with the safeguards in this Regulation. 2. Where an institution is a group entity, without prejudice to Article 14, the Board, the Council and the Commission, when deciding on the application of resolution tools and the exercise of resolution powers, shall act in a way that minimises the impact on other group entities and on the group as a whole and minimises the adverse effect on financial stability in the Union and its Member States, in particular in the countries where the group operates. 3. Where the sale of business tool, the bridge institution tool or the asset separation tool is applied to an entity referred to in Article 2 of this Regulation, that entity shall be considered to be the subject of bankruptcy proceedings or analogous insolvency proceedings for the purposes of Article 5(1) of Council Directive 2001/23/EC (16). 4. When deciding on the application of resolution tools and the exercise of resolution powers, the Board shall instruct national resolution authorities to inform and consult employee representatives where appropriate. This is without prejudice to provisions on the representation of employees in management bodies as provided for by national law or practice. Article 16 Resolution of financial institutions and parent undertakings 1. The Board shall decide on a resolution action in relation to a financial institution established in a participating Member State, where the conditions laid down in Article 18(1) are met with regard to both the financial institution and with regard to the parent undertaking subject to consolidating supervision. 2. The Board shall take a resolution action in relation to a parent undertaking referred to in point (b) of Article 2, where the conditions laid down in Article 18(1) are met with regard to both that parent undertaking and with regard to one or more subsidiaries which are institutions or, where the subsidiary is not established in the Union, the third-country authority has determined that it meets the conditions for resolution under the law of that third country. 3. By way of derogation from paragraph 2 and notwithstanding the fact that a parent undertaking does not meet the conditions established in Article 18(1), the Board may decide on resolution action with regard to that parent undertaking when one or more of its subsidiaries which are institutions meet the conditions established in Article 18(1), (4) and (5) and their assets and liabilities are such that their failure threatens an institution or the group as a whole and resolution action with regard to that parent undertaking is necessary for the resolution of such subsidiaries which are institutions or for the resolution of the group as a whole. Where a national resolution authority informs the Board that the insolvency law of the Member State provides that groups be treated as a whole and resolution action with regard to the parent undertaking is necessary for the resolution of such subsidiaries which are institutions or for the resolution of the group as a whole, the Board may also decide on resolution action with regard to the parent undertaking. For the purposes of the first subparagraph, when assessing whether the conditions in Article 18(1) are met in respect of one or more subsidiaries which are institutions, the Board may disregard any intra-group capital or loss transfers between the entities, including the exercise of write-down or conversion powers. Article 17 Order of priority of claims 1. When applying the bail-in tool to an entity referred to in Article 2 of this Regulation, and without prejudice to liabilities excluded from the bail-in tool under Article 27(3) of this Regulation, the Board, the Commission, or, where applicable, the national resolution authorities, shall decide on the exercise of the write-down and conversion powers, including on any possible application of Article 27(5) of this Regulation, and the national resolution authorities shall exercise those powers in accordance with Articles 47 and 48 of Directive 2014/59/EU and in accordance with the reverse order of priority of claims laid down in their national law, including the provisions transposing Article 108 of that Directive. 2. Participating Member States shall notify to the Commission and to the Board the ranking of claims against entities referred to in Article 2 in national insolvency proceedings on 1 July of every year or immediately, where there is a change of the ranking. Where the bail-in tool is applied, the relevant deposit guarantee scheme shall be liable in the terms provided for in Article 79. Article 18 Resolution procedure 1. The Board shall adopt a resolution scheme pursuant to paragraph 6 in relation to entities and groups referred to in Article 7(2), and to the entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met, only when it assesses, in its executive session, on receiving a communication pursuant to the fourth subparagraph, or on its own initiative, that the following conditions are met: (a) the entity is failing or is likely to fail; (b) having regard to timing and other relevant circumstances, there is no reasonable prospect that any alternative private sector measures, including measures by an IPS, or supervisory action, including early intervention measures or the write-down or conversion of relevant capital instruments in accordance with Article 21, taken in respect of the entity, would prevent its failure within a reasonable timeframe; (c) a resolution action is necessary in the public interest pursuant to paragraph 5. An assessment of the condition referred to in point (a) of the first subparagraph shall be made by the ECB, after consulting the Board. The Board, in its executive session, may make such an assessment only after informing the ECB of its intention and only if the ECB, within three calendar days of receipt of that information, does not make such an assessment. The ECB shall, without delay, provide the Board with any relevant information that the Board requests in order to inform its assessment. Where the ECB assesses that the condition referred to in point (a) of the first subparagraph is met in relation to an entity or group referred to in the first subparagraph, it shall communicate that assessment without delay to the Commission and to the Board. An assessment of the condition referred to in point (b) of the first subparagraph shall be made by the Board, in its executive session, or, where applicable, by the national resolution authorities, in close cooperation with the ECB. The ECB may also inform the Board or the national resolution authorities concerned that it considers the condition laid down in that point to be met. 2. Without prejudice to cases where the ECB has decided to exercise directly supervisory tasks relating to credit institutions pursuant to Article 6(5)(b) of Regulation (EU) No 1024/2013, in the event of receipt of a communication pursuant to paragraph 1 or where the Board intends to make an assessment under paragraph 1 on its own initiative in relation to an entity or group referred to in Article 7(3), the Board shall communicate its assessment to the ECB without delay. 3. The previous adoption of a measure pursuant to Article 16 of Regulation (EU) No 1024/2013, to Article 27(1) or Article 28 or 29 of Directive 2014/59/EU, or to Article 104 of Directive 2013/36/EU is not a condition for taking a resolution action. 4. For the purposes of point (a) of paragraph 1, the entity shall be deemed to be failing or to be likely to fail in one or more of the following circumstances: (a) the entity infringes, or there are objective elements to support a determination that the institution will, in the near future, infringe the requirements for continuing authorisation in a way that would justify the withdrawal of the authorisation by the ECB, including but not limited to the fact that the institution has incurred or is likely to incur losses that will deplete all or a significant amount of its own funds; (b) the assets of the entity are, or there are objective elements to support a determination that the assets of the entity will, in the near future, be less than its liabilities; (c) the entity is, or there are objective elements to support a determination that the entity will, in the near future, be unable to pay its debts or other liabilities as they fall due; (d) extraordinary public financial support is required except where, in order to remedy a serious disturbance in the economy of a Member State and preserve financial stability, that extraordinary public financial support takes any of the following forms: (i) a State guarantee to back liquidity facilities provided by central banks in accordance with the central banks' conditions; (ii) a State guarantee of newly issued liabilities; or (iii) an injection of own funds or purchase of capital instruments at prices and on terms that do not confer an advantage upon the entity, where neither the circumstances referred to in points (a), (b) and (c) of this paragraph nor the circumstances referred to in Article 21(1) are present at the time the public support is granted. In each of the cases referred to in points (i), (ii) and (iii) of point (d) of the first subparagraph, the guarantee or equivalent measures referred to therein shall be confined to solvent entities and shall be conditional on final approval under the Union State aid framework. Those measures shall be of a precautionary and temporary nature and shall be proportionate to remedy the consequences of the serious disturbance and shall not be used to offset losses that the entity has incurred or is likely to incur in the near future. Support measures under point (d)(iii) of the first subparagraph shall be limited to injections necessary to address capital shortfall established in the national, Union or SSM-wide stress tests, asset quality reviews or equivalent exercises conducted by the ECB, EBA or national authorities, where applicable, confirmed by the competent authority. If the Commission submits a legislative proposal pursuant to Article 32(4) of Directive 2014/59/EU, it shall, if appropriate, submit a legislative proposal amending this Regulation in the same way. 5. For the purposes of point (c) of paragraph 1 of this Article, a resolution action shall be treated as in the public interest if it is necessary for the achievement of, and is proportionate to one or more of the resolution objectives referred to in Article 14 and winding up of the entity under normal insolvency proceedings would not meet those resolution objectives to the same extent. 6. If the conditions laid down in paragraph 1 are met, the Board shall adopt a resolution scheme. The resolution scheme shall: (a) place the entity under resolution; (b) determine the application of the resolution tools to the institution under resolution referred to in Article 22(2), in particular any exclusions from the application of the bail-in in accordance with Article 27(5) and (14); (c) determine the use of the Fund to support the resolution action in accordance with Article 76 and in accordance with a Commission decision taken in accordance with Article 19. 7. Immediately after the adoption of the resolution scheme, the Board shall transmit it to the Commission. Within 24 hours from the transmission of the resolution scheme by the Board, the Commission shall either endorse the resolution scheme, or object to it with regard to the discretionary aspects of the resolution scheme in the cases not covered in the third subparagraph of this paragraph. Within 12 hours from the transmission of the resolution scheme by the Board, the Commission may propose to the Council: (a) to object to the resolution scheme on the ground that the resolution scheme adopted by the Board does not fulfil the criterion of public interest referred to in paragraph 1(c); (b) to approve or object to a material modification of the amount of the Fund provided for in the resolution scheme of the Board. For the purposes of the third subparagraph, the Council shall act by simple majority. The resolution scheme may enter into force only if no objection has been expressed by the Council or by the Commission within a period of 24 hours after its transmission by the Board. The Council or the Commission, as the case may be, shall provide reasons for the exercise of their power of objection. Where, within 24 hours from the transmission of the resolution scheme by the Board, the Council has approved the proposal of the Commission for modification of the resolution scheme on the ground referred to in point (b) of the third subparagraph or the Commission has objected in accordance with the second subparagraph, the Board shall, within eight hours modify the resolution scheme in accordance with the reasons expressed. Where the resolution scheme adopted by the Board provides for the exclusion of certain liabilities in the exceptional circumstances referred to in Article 27(5), and where such exclusion requires a contribution by the Fund or an alternative financing source, in order to protect the integrity of the internal market, the Commission may prohibit or require amendments to the proposed exclusion setting out adequate reasons based on an infringement of the requirements laid down in Article 27 and in the delegated act adopted by the Commission on the basis of Article 44(11) of Directive 2014/59/EU. 8. Where the Council objects to the placing of an institution under resolution on the ground that the public interest criterion referred to in paragraph 1(c) is not fulfilled, the relevant entity shall be wound up in an orderly manner in accordance with the applicable national law. 9. The Board shall ensure that the necessary resolution action is taken to carry out the resolution scheme by the relevant national resolution authorities. The resolution scheme shall be addressed to the relevant national resolution authorities and shall instruct those authorities, which shall take all necessary measures to implement it in accordance with Article 29, by exercising resolution powers. Where State aid or Fund aid is present, the Board shall act in conformity with a decision on that aid taken by the Commission. 10. The Commission shall have the power to obtain from the Board any information which it deems to be relevant for performing its tasks under this Regulation. The Board shall have the power to obtain from any person, in accordance with Chapter 5 of this Title, any information necessary for it to prepare and decide upon a resolution action, including updates and supplements of information provided in the resolution plans. Article 19 State aid and Fund aid 1. Where resolution action involves the granting of State aid pursuant to Article 107(1) TFEU or of Fund aid in accordance with paragraph 3 of this Article, the adoption of the resolution scheme under Article 18(6) of this Regulation shall not take place until such time as the Commission has adopted a positive or conditional decision concerning the compatibility of the use of such aid with the internal market. In performing the tasks conferred on them by Article 18 of this Regulation, Union institutions shall act in conformity with the principles established in Article 3(3) of Directive 2014/59/EU and shall make public in an appropriate manner all relevant information on their internal organisation in this regard. 2. On receiving a communication pursuant to Article 18(1) of this Regulation or on its own initiative, if the Board considers that resolution actions could constitute State aid pursuant to Article 107(1) TFEU, it shall invite the participating Member State or Member States concerned to immediately notify the envisaged measures to the Commission under Article 108(3) TFEU. The Board shall notify the Commission of any case in which it invites one or more Member States to make a notification under Article 108(3) TFEU. 3. To the extent that the resolution action as proposed by the Board involves the use of the Fund, the Board shall notify the Commission of the proposed use of the Fund. The Board's notification shall include all of the information necessary to enable the Commission to make its assessments pursuant to this paragraph. The notification under this paragraph shall trigger a preliminary investigation by the Commission during the course of which the Commission may request further information from the Board. The Commission shall assess whether the use of the Fund would distort, or threaten to distort, competition by favouring the beneficiary or any other undertaking so as, insofar as it would affect trade between Member States, to be incompatible with the internal market. The Commission shall apply to the use of the Fund the criteria established for the application of State aid rules as enshrined in Article 107 TFEU. The Board shall provide the Commission with the information that the Commission deems to be necessary to carry out that assessment. If the Commission has serious doubts as to the compatibility of the proposed use of the Fund with the internal market, or where the Board has failed to provide the necessary information pursuant to a request of the Commission under the second subparagraph, the Commission shall open an in-depth investigation and shall notify the Board accordingly. The Commission shall publish its decision to open an in-depth investigation in the Official Journal of the European Union. The Board, any Member State or any person, undertaking or association whose interests may be affected by the use of the Fund, may submit comments to the Commission within such timeframe as may be specified in the notification. The Board may submit observations on the comments submitted by Member States and interested third parties within such timeframe as may be specified by the Commission. At the end of the period of investigation the Commission shall make its assessment as to whether the use of the Fund would be compatible with the internal market. In making its assessments and conducting its investigations pursuant to this paragraph, the Commission shall be guided by all of the relevant regulations adopted under Article 109 TFEU as well as relevant communications, guidance and measures adopted by the Commission in application of the rules of the Treaties relating to State aid as are in force at the time the assessment is to be made. Those measures shall be applied as though references to the Member State responsible for notifying the aid were references to the Board, and with any other necessary modifications. The Commission shall adopt a decision on the compatibility of the use of the Fund with the internal market, which shall be addressed to the Board and to the national resolution authorities of the Member State or Member States concerned. That decision may be contingent on conditions, commitments or undertakings in respect of the beneficiary. The decision may also lay down obligations on the Board, the national resolution authorities in the participating Member State or Member States concerned or the beneficiary to enable compliance with it to be monitored. This may include requirements for the appointment of a trustee or other independent person to assist in monitoring. A trustee or other independent person may perform such functions as may be specified in the Commission decision. Any decision pursuant to this paragraph shall be published in the Official Journal of the European Union. The Commission may issue a negative decision, addressed to the Board, where it decides that the proposed use of the Fund would be incompatible with the internal market and cannot be implemented in the form proposed by the Board. On receipt of such a decision the Board shall reconsider its resolution scheme and prepare a revised resolution scheme. 4. Where the Commission has serious doubts as to whether its decision under paragraph 3 is being complied with, it shall conduct the necessary investigations. For that purpose, the Commission may exercise such powers as are available to it under the regulations and other measures referred to in the fourth subparagraph of paragraph 3, and shall be guided by them. 5. If, on the basis of the investigations carried out by the Commission, and after giving notice to the parties concerned to submit their comments, the Commission considers that the decision under paragraph 3 has not been complied with, it shall issue a decision to the national resolution authority in the participating Member State concerned requiring that authority to recover the misused amounts within a period to be determined by the Commission. The Fund aid to be recovered pursuant to a recovery decision shall include interest at an appropriate rate fixed by the Commission and shall be paid over to the Board. The Board shall pay any amounts received under the first subparagraph into the Fund and take such amounts into consideration when determining contributions in accordance with Articles 70 and 71. The recovery procedure referred to in the first subparagraph shall respect the right to good administration and the right of access to documents, of the beneficiaries, as laid down in Articles 41 and 42 of the Charter. 6. Without prejudice to the reporting obligations that the Commission may establish in its decision under paragraph 3 of this Article, the Board shall submit to the Commission annual reports assessing the compliance of the use of the Fund with the decision under that paragraph, for the drawing up of which the Board shall make use of its powers under Article 34. 7. Any Member State or any person, undertaking or association whose interests may be affected by the use of the Fund, in particular the entities referred to in Article 2, shall have the right to inform the Commission of any suspected misuse of the Fund incompatible with the decision under paragraph 3 of this Article. 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 93 concerning detailed rules of procedure concerning: (a) the calculation of the interest rate to be applied in the event of a recovery decision in accordance with paragraph 5; (b) the guarantees of the right to good administration and the right of access to documents referred to in paragraph 5. 9. Where the Commission, following a recommendation of the Board or on its own initiative, considers that the application of resolution tools and actions does not respond to the criteria on the basis of which its initial decision under paragraph 3 was made, it may review such a decision and adopt the appropriate amendments. 10. By way of derogation from paragraph 3, on application by a Member State, the Council may, acting unanimously, decide that the use of the Fund shall be considered to be compatible with the internal market, if such a decision is justified by exceptional circumstances. If, however, the Council has not made its attitude known within seven days of the said application being made, the Commission shall give its decision on the case. 11. Participating Member States shall ensure that their national resolution authorities have the powers necessary to ensure compliance with any conditions laid down in a Commission decision pursuant to paragraph 3 and to recover misused amounts pursuant to a Commission decision under paragraph 5. Article 20 Valuation for the purposes of resolution 1. Before deciding on resolution action or the exercise of the power to write down or convert relevant capital instruments, the Board shall ensure that a fair, prudent and realistic valuation of the assets and liabilities of an entity referred to in Article 2 is carried out by a person independent from any public authority, including the Board and the national resolution authority, and from the entity concerned. 2. Subject to paragraph 15, where all of the requirements laid down in paragraphs 1 and 4 to 9 are met, the valuation shall be considered to be definitive. 3. Where an independent valuation in accordance with paragraph 1 is not possible, the Board may carry out a provisional valuation of the assets and liabilities of the entity referred to in Article 2, in accordance with paragraph 10 of this Article. 4. The objective of the valuation shall be to assess the value of the assets and liabilities of an entity referred to in Article 2 that meets the conditions for resolution of Articles 16 and 18. 5. The purposes of the valuation shall be: (a) to inform the determination of whether the conditions for resolution or the conditions for the write-down or conversion of capital instruments are met; (b) if the conditions for resolution are met, to inform the decision on the appropriate resolution action to be taken in respect of an entity referred to in Article 2; (c) when the power to write down or convert relevant capital instruments is applied, to inform the decision on the extent of the cancellation or dilution of instruments of ownership, and the extent of the write-down or conversion of relevant capital instruments; (d) when the bail-in tool is applied, to inform the decision on the extent of the write-down or conversion of eligible liabilities; (e) when the bridge institution tool or asset separation tool is applied, to inform the decision on the assets, rights, liabilities or instruments of ownership to be transferred and the decision on the value of any consideration to be paid to the institution under resolution or, as the case may be, to the owners of the instruments of ownership; (f) when the sale of business tool is applied, to inform the decision on the assets, rights, liabilities or instruments of ownership to be transferred and to inform the Board's understanding of what constitutes commercial terms for the purposes of Article 24(2)(b); (g) in all cases, to ensure that any losses on the assets of an entity referred to in Article 2 are fully recognised at the moment the resolution tools are applied or the power to write down or convert relevant capital instruments is exercised. 6. Without prejudice to the Union State aid framework, where applicable, the valuation shall be based on prudent assumptions, including as to rates of default and severity of losses. The valuation shall not assume any potential future provision of any extraordinary public financial support, any central bank emergency liquidity assistance, or any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms to an entity referred to in Article 2 from the point at which resolution action is taken or the power to write down or convert relevant capital instruments is exercised. Furthermore, the valuation shall take account of the fact that, if any resolution tool is applied: (a) the Board may recover any reasonable expenses properly incurred from the institution under resolution, in accordance with Article 22(6); (b) the Fund may charge interest or fees in respect of any loans or guarantees provided to the institution under resolution, in accordance with Article 76. 7. The valuation shall be supplemented by the following information as appearing in the accounting books and records of an entity referred to in Article 2: (a) an updated balance sheet and a report on the financial position of an entity referred to in Article 2; (b) an analysis and an estimate of the accounting value of the assets; (c) the list of outstanding on-balance-sheet and off-balance-sheet liabilities shown in the books and records of an entity referred to in Article 2, with an indication of the respective credits and priority of claims referred to in Article 17. 8. Where appropriate, to inform the decisions referred to in paragraph 5(e) and (f) of this Article, the information in paragraph 7(b) of this Article may be complemented by an analysis and estimate of the value of the assets and liabilities of an entity referred to in Article 2 on a market value basis. 9. The valuation shall indicate the subdivision of the creditors in classes in accordance with the priority of claims referred to in Article 17 and an estimate of the treatment that each class of shareholders and creditors would have been expected to receive, if an entity referred to in Article 2 were wound up under normal insolvency proceedings. That estimate shall not affect the application of the \u2018no creditor worse off\u2019 principle referred to in Article 15(1)(g). 10. Where, due to urgency in the circumstances of the case, either it is not possible to comply with the requirements laid down in paragraphs 7 and 9, or paragraph 3 applies, a provisional valuation shall be carried out. The provisional valuation shall comply with the requirements laid down in paragraph 4 and, in so far as reasonably practicable in the circumstances, with the requirements laid down in paragraphs 1, 7 and 9. The provisional valuation referred to in the first subparagraph shall include a buffer for additional losses, with appropriate justification. 11. A valuation that does not comply with all of the requirements laid down in paragraphs 1 and 4 to 9 shall be considered to be provisional until an independent person as referred to in paragraph 1 has carried out a valuation that is fully compliant with all of the requirements laid down in those paragraphs. That ex-post definitive valuation shall be carried out as soon as practicable. It may be carried out either separately from the valuation referred to in paragraphs 16, 17 and 18, or simultaneously with and by the same independent person as that valuation, but shall be distinct from it. The purposes of the ex-post definitive valuation shall be: (a) to ensure that any losses on the assets of an entity referred to in Article 2 are fully recognised in the books of accounts of that entity; (b) to inform the decision to write back creditors' claims or to increase the value of the consideration paid, in accordance with paragraph 12 of this Article. 12. In the event that the ex-post definitive valuation's estimate of the net asset value of an entity referred to in Article 2 is higher than the provisional valuation's estimate of the net asset value of that entity, the Board may request the national resolution authority to: (a) exercise its power to increase the value of the claims of creditors or owners of relevant capital instruments which have been written down under the bail-in tool; (b) instruct a bridge institution or asset management vehicle to make a further payment of consideration in respect of the assets, rights or liabilities to an institution under resolution, or as the case may be, in respect of the instruments of ownership to the owners of those instruments of ownership. 13. Notwithstanding paragraph 1, a provisional valuation conducted in accordance with paragraphs 10 and 11 shall be a valid basis for the Board to decide on resolution actions, including instructing national resolution authorities to take control of a failing institution or on the exercise of the write-down or conversion power of relevant capital instruments. 14. The Board shall establish and maintain arrangements to ensure that the assessment for the application of the bail-in tool in accordance with Article 27 and the valuation referred to in paragraphs 1 to 15 of this Article are based on information about the assets and liabilities of the institution under resolution that is as up to date and complete as is reasonably possible. 15. The valuation shall be an integral part of the decision on the application of a resolution tool or on the exercise of a resolution power or the decision on the exercise of the write-down or conversion power of capital instruments. The valuation itself shall not be subject to a separate right of appeal but may be subject to an appeal together with the decision of the Board. 16. For the purposes of assessing whether shareholders and creditors would have received better treatment if the institution under resolution had entered into normal insolvency proceedings, the Board shall ensure that a valuation is carried out by an independent person as referred to in paragraph 1 as soon as possible after the resolution action or actions have been effected. That valuation shall be distinct from the valuation carried out under paragraphs 1 to 15. 17. The valuation referred to in paragraph 16 shall determine: (a) the treatment that shareholders and creditors, or the relevant deposit guarantee schemes, would have received if an institution under resolution with respect to which the resolution action or actions have been effected, had entered normal insolvency proceedings at the time when the decision on the resolution action was taken; (b) the actual treatment that shareholders and creditors have received in the resolution of an institution under resolution; and (c) whether there is any difference between the treatment referred to in point (a) of this paragraph and the treatment referred to in point (b) of this paragraph. 18. The valuation referred to in paragraph 16 shall: (a) assume that an institution under resolution with respect to which the resolution action or actions have been effected, would have entered normal insolvency proceedings at the time when the decision on the resolution action was taken; (b) assume that the resolution action or actions had not been effected; (c) disregard any provision of extraordinary public financial support to an institution under resolution. Article 21 Write-down and conversion of capital instruments 1. The Board shall exercise the power to write down or convert relevant capital instruments acting under the procedure laid down in Article 18, in relation to the entities and groups referred to in Article 7(2), and to the entities and groups referred to in Article 7(4)(b) and (5), where the conditions for the application of those paragraphs are met, only where it assesses, in its executive session, on receiving a communication pursuant to the second subparagraph or on its own initiative, that one or more of the following conditions are met: (a) where the determination has been made that the conditions for resolution specified in Articles 16 and 18 have been met, before any resolution action is taken; (b) the entity will no longer be viable unless the relevant capital instruments are written down or converted into equity; (c) in the case of relevant capital instruments issued by a subsidiary and where those relevant capital instruments are recognised for the purposes of meeting own funds requirements on an individual basis and on a consolidated basis, unless the write-down or conversion power is exercised in relation to those instruments, the group will no longer be viable; (d) in the case of relevant capital instruments issued at the level of the parent undertaking and where those relevant capital instruments are recognised for the purposes of meeting own funds requirements on an individual basis at the level of the parent undertaking or on a consolidated basis, unless the write-down or conversion power is exercised in relation to those instruments, the group will no longer be viable; (e) extraordinary public financial support is required by the entity or group, except in any of the circumstances set out in point (d)(iii) of Article 18(4). The assessment of the conditions referred to in points (a), (c) and (d) of the first subparagraph shall be made by the ECB, after consulting the Board. The Board, in its executive session, may also make such assessment. 2. Regarding the assessment of whether the entity or group is viable, the Board, in its executive session, may make such an assessment only after informing the ECB of its intention and only if the ECB, within three calendar days of receipt of such information, does not make such an assessment. The ECB shall, without delay, provide the Board with any relevant information that the Board requests in order to inform its assessment. 3. For the purposes of paragraph 1 of this Article, an entity referred to in Article 2 or a group shall be deemed to be no longer viable only if both of the following conditions are met: (a) that entity or group is failing or is likely to fail; (b) having regard to timing and other relevant circumstances, there is no reasonable prospect that any action, including alternative private sector measures or supervisory action (including early intervention measures), other than the write-down or conversion of relevant capital instruments, independently or in combination with resolution action, would prevent the failure of that entity or group within a reasonable timeframe. 4. For the purposes of point (a) of paragraph 3 of this Article, that entity shall be deemed to be failing or to be likely to fail where one or more of the circumstances referred to in Article 18(4) occur. 5. For the purposes of point (a) of paragraph 3, a group shall be deemed to be failing or to be likely to fail where the group infringes, or there are objective elements to support a determination that the group, in the near future, will infringe its consolidated prudential requirements in a way that would justify action by the ECB or the national competent authority, including but not limited to the fact that the group has incurred or is likely to incur losses that will deplete all or a significant amount of its own funds. 6. A relevant capital instrument issued by a subsidiary shall not be written down to a greater extent or converted on worse terms pursuant to Article 59(3)(c) of Directive 2014/59/EU than equally ranked capital instruments at the level of the parent undertaking which have been written down or converted. 7. If one or more of the conditions referred to in paragraph 1 are met, the Board, acting under the procedure laid down in Article 18, shall determine whether the powers to write down or convert relevant capital instruments are to be exercised independently or, in accordance with the procedure under Article 18, in combination with a resolution action. 8. Where the Board, acting under the procedure laid down in Article 18 of this Regulation, determines that one or more of the conditions referred to in paragraph 1 of this Article are met, but the conditions for resolution in accordance with Article 18(1) of this Regulation are not met, it shall instruct, without delay, the national resolution authorities to exercise the write-down or conversion powers in accordance with Articles 59 and 60 of Directive 2014/59/EU. The Board shall ensure that before national resolution authorities exercise the power to write down or convert relevant capital instruments, a valuation of the assets and liabilities of an entity referred to in Article 2 or a group is carried out in accordance with Article 20(1) to (15). That valuation shall form the basis of the calculation of the write-down to be applied to the relevant capital instruments in order to absorb losses and the level of conversion to be applied to relevant capital instruments in order to recapitalise the entity referred to in Article 2 or the group. 9. Where one or more of the conditions referred to in paragraph 1 are met, and the conditions referred to in Article 18(1) are also met, the procedure laid down in Article 18(6), (7) and (8) shall apply. 10. The Board shall ensure that the national resolution authorities exercise the write-down or conversion powers without delay, in accordance with the priority of claims pursuant to Article 17 and in a way that produces the following results: (a) Common Equity Tier 1 items are reduced first in proportion to the losses and to the extent of their capacity; (b) the principal amount of Additional Tier 1 instruments is written down or converted into Common Equity Tier 1 instruments or both, to the extent required to achieve the resolution objectives set out in Article 14 or to the extent of the capacity of the relevant capital instruments, whichever is lower; (c) the principal amount of Tier 2 instruments is written down or converted into Common Equity Tier 1 instruments or both, to the extent required to achieve the resolution objectives set out in Article 14 or to the extent of the capacity of the relevant capital instruments, whichever is lower. 11. The national resolution authorities shall implement the instructions of the Board and exercise the write-down or conversion of relevant capital instruments in accordance with Article 29. Article 22 General principles of resolution tools 1. Where the Board decides to apply a resolution tool to an entity or group referred to in Article 7(2) or to an entity or group referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met, and that resolution action would result in losses being borne by creditors or their claims being converted, the Board shall instruct the national resolution authorities to exercise the power to write down and convert relevant capital instruments in accordance with Article 21 immediately before or together with the application of the resolution tool. 2. The resolution tools referred to in point (b) of Article 18(6) are the following: (a) the sale of business tool; (b) the bridge institution tool; (c) the asset separation tool; (d) the bail-in tool. 3. When adopting the resolution scheme referred to in Article 18(6), the Board shall take into consideration the following factors: (a) the assets and liabilities of the institution under resolution on the basis of the valuation pursuant to Article 20; (b) the liquidity position of the institution under resolution; (c) the marketability of the franchise value of the institution under resolution in the light of the competitive and economic conditions of the market; (d) the time available. 4. The resolution tools shall be applied to meet the resolution objectives specified in Article 14, in accordance with the resolution principles specified in Article 15. They may be applied either individually or in any combination, except for the asset separation tool which may be applied only together with another resolution tool. 5. Where the resolution tools referred to in point (a) or (b) of paragraph 2 of this Article are used to transfer only part of the assets, rights or liabilities of the institution under resolution, the residual entity referred to in Article 2 from which the assets, rights or liabilities have been transferred, shall be wound up under normal insolvency proceedings. 6. The Board may recover any reasonable expenses properly incurred in connection with the use of the resolution tools or powers in one or more of the following ways: (a) as a deduction from any consideration paid by a recipient to the institution under resolution or, as the case may be, to the owners of instruments of ownership; (b) from the institution under resolution, as a preferred creditor; or (c) from any proceeds generated as a result of the termination of the operation of the bridge institution or the asset management vehicle, as a preferred creditor. Any proceeds received by national resolution authorities in connection with the use of the Fund shall be reimbursed to the Board. Article 23 Resolution Scheme The resolution scheme adopted by the Board under Article 18 shall establish, in accordance with any decision on State aid or Fund aid, the details of the resolution tools to be applied to the institution under resolution concerning at least the measures referred to in Article 24(2), Article 25(2), Article 26(2) and Article 27(1), to be implemented by the national resolution authorities in accordance with the relevant provisions of Directive 2014/59/EU as transposed into national law, and determine the specific amounts and purposes for which the Fund shall be used. The resolution scheme shall outline the resolution actions that should be taken by the Board in relation to the Union parent undertaking or particular group entities established in the participating Member States with the aim of meeting the resolution objectives and principles as referred to in Articles 14 and 15. When adopting a resolution scheme, the Board, the Council and the Commission shall take into account and follow the resolution plan as referred to in Article 8 unless the Board assesses, taking into account the circumstances of the case, that the resolution objectives will be achieved more effectively by taking actions which are not provided for in the resolution plan. In the course of the resolution process, the Board may amend and update the resolution scheme as appropriate in light of the circumstances of the case. For amendments and updates the procedure laid down in Article 18 shall apply. In addition, the resolution scheme shall provide, where appropriate, for the appointment by the national resolution authorities of a special manager for the institution under resolution pursuant to Article 35 of Directive 2014/59/EU. The Board may establish that the same special manager is appointed for all of the entities affiliated to a group where that is necessary in order to facilitate solutions redressing the financial soundness of the entities concerned. Article 24 Sale of business tool 1. Within the resolution scheme, the sale of business tool shall consist of the transfer to a purchaser that is not a bridge institution of the following: (a) instruments of ownership issued by an institution under resolution; or (b) all or any assets, rights or liabilities of an institution under resolution. 2. Concerning the sale of business tool, the resolution scheme shall establish: (a) the instruments, assets, rights and liabilities to be transferred by the national resolution authority in accordance with Article 38(1) and (7) to (11) of Directive 2014/59/EU; (b) the commercial terms, having regard to the circumstances and the costs and expenses incurred in the resolution process, pursuant to which the national resolution authority shall make the transfer in accordance with Article 38(2), (3) and (4) of Directive 2014/59/EU; (c) whether the transfer powers may be exercised by the national resolution authority more than once in accordance with Article 38(5) and (6) of Directive 2014/59/EU; (d) the arrangements for the marketing by the national resolution authority of that entity or those instruments, assets, rights and liabilities in accordance with Article 39(1) and (2) of Directive 2014/59/EU; (e) whether the compliance with the marketing requirements by the national resolution authority is likely to undermine the resolution objectives in accordance with paragraph 3 of this Article. 3. The Board shall apply the sale of business tool without complying with the marketing requirements laid down in point (e) of paragraph 2 when it determines that compliance with those requirements would be likely to undermine one or more of the resolution objectives and in particular where the following conditions are met: (a) it considers that there is a material threat to financial stability arising from or aggravated by the failure or likely failure of the institution under resolution; and (b) it considers that compliance with those requirements would be likely to undermine the effectiveness of the sale of business tool in addressing that threat or achieving the resolution objective specified in point (b) of Article 14(2). Article 25 Bridge institution tool 1. Within the resolution scheme, the bridge institution tool shall consist of the transfer to a bridge institution of any of the following: (a) instruments of ownership issued by one or more institutions under resolution; (b) all or any assets, rights or liabilities of one or more institutions under resolution. 2. With regard to the bridge institution tool, the resolution scheme shall establish: (a) the instruments, assets, rights and liabilities to be transferred to a bridge institution by the national resolution authority in accordance with Article 40(1) to (12) of Directive 2014/59/EU; (b) the arrangements for the setting up, the operation and the termination of the bridge institution by the national resolution authority in accordance with Article 41(1), (2), (3) and (5) to (9) of Directive 2014/59/EU; (c) the arrangements for the marketing of the bridge institution or its assets or liabilities by the national resolution authority in accordance with Article 41(4) of Directive 2014/59/EU. 3. The Board shall ensure that the total value of liabilities transferred by the national resolution authority to the bridge institution does not exceed the total value of the rights and assets transferred from the institution under resolution or provided by other sources. Article 26 Asset separation tool 1. Within the resolution scheme, the asset separation tool shall consist of the transfer of assets, rights or liabilities of an institution under resolution or a bridge institution to one or more asset management vehicles. 2. Concerning the asset separation tool, the resolution scheme shall establish: (a) the assets, rights and liabilities to be transferred by the national resolution authority to an asset management vehicle in accordance with Article 42(1) to (5) and (8) to (13) of Directive 2014/59/EU; (b) the consideration for which the assets, rights and liabilities are to be transferred by the national resolution authority to the asset management vehicle in accordance with the principles established in Article 20 of this Regulation, with Article 42(7) of Directive 2014/59/EU and with the Union State aid framework. Point (b) of the first subparagraph shall not prevent the consideration having nominal or negative value. Article 27 Bail-in tool 1. The bail-in tool may be applied for any of the following purposes: (a) to recapitalise an entity referred to in Article 2 of this Regulation that meets the conditions for resolution to the extent sufficient to restore its ability to comply with the conditions for authorisation (to the extent that those conditions apply to the entity) and to continue to carry out the activities for which it is authorised under Directive 2013/36/EU or Directive 2014/65/EU, where the entity is authorised under those Directives, and to sustain sufficient market confidence in the institution or entity; (b) to convert to equity or reduce the principal amount of claims or debt instruments that are transferred: (i) to a bridge institution with a view to providing capital for that bridge institution; or (ii) under the sale of business tool or the asset separation tool. Within the resolution scheme, concerning the bail-in tool, the following shall be established: (a) the aggregate amount by which eligible liabilities must be reduced or converted, in accordance with paragraph 13; (b) the liabilities that may be excluded in accordance with paragraphs 5 to 14; (c) the objectives and minimum content of the business reorganisation plan to be submitted in accordance with paragraph 16. 2. The bail-in tool may be applied for the purpose referred to in point (a) of paragraph 1 only if there is a reasonable prospect that the application of that tool, together with other relevant measures including measures implemented in accordance with the business reorganisation plan required by paragraph 16 will, in addition to achieving relevant resolution objectives, restore the entity in question to financial soundness and long-term viability. Any of the resolution tools referred to in Article 22(2)(a), (b) and (c), and the bail-in tool referred to in point (d) of that paragraph, shall apply, as appropriate, where the conditions laid down in the first subparagraph are not met. 3. The following liabilities, whether they are governed by the law of a Member State or of a third country, shall not be subject to write-down or conversion: (a) covered deposits; (b) secured liabilities including covered bonds and liabilities in the form of financial instruments used for hedging purposes which form an integral part of the cover pool and which, in accordance with national law, are secured in a way similar to covered bonds; (c) any liability that arises by virtue of the holding by an institution or entity referred to in Article 2 of this Regulation of client assets or client money, including client assets or client money held on behalf of UCITS as defined in Article 1(2) of Directive 2009/65/EC or of AIFs as defined in Article 4(1)(a) of Directive 2011/61/EU of the European Parliament and of the Council (17), provided that such client is protected under the applicable insolvency law; (d) any liability that arises by virtue of a fiduciary relationship between an entity referred to in Article 2 (as fiduciary) and another person (as beneficiary), provided that such beneficiary is protected under the applicable insolvency or civil law; (e) liabilities to institutions, excluding entities that are part of the same group, with an original maturity of less than seven days; (f) liabilities with a remaining maturity of less than seven days, owed to systems or operators of systems designated in accordance with Directive 98/26/EC of the European Parliament and of the Council (18) or their participants and arising from the participation in such a system; (g) a liability to any one of the following: (i) an employee, in relation to accrued salary, pension benefits or other fixed remuneration, except for the variable component of remuneration that is not regulated by a collective bargaining agreement; (ii) a commercial or trade creditor arising from the provision to the institution or entity referred to in Article 2 of goods or services that are critical to the daily functioning of its operations, including IT services, utilities and the rental, servicing and upkeep of premises; (iii) tax and social security authorities, provided that those liabilities are preferred under the applicable law; (iv) deposit guarantee schemes arising from contributions due in accordance with Directive 2014/49/EU. Point (g)(i) of the first subparagraph shall not apply to the variable component of the remuneration of material risk takers as identified in Article 92(2) of Directive 2013/36/EU. 4. The scope of the bail-in tool referred to in paragraph 3 of this Article shall not prevent, where appropriate, the exercise of the bail-in powers to any part of a secured liability or a liability for which collateral has been pledged that exceeds the value of the assets, pledge, lien or collateral against which it is secured or to any amount of a deposit that exceeds the coverage level provided for in Article 6 of Directive 2014/49/EU. The Board shall ensure that all secured assets relating to a covered bond cover pool remain unaffected, segregated and with enough funding. Without prejudice to the large exposure rules in Regulation (EU) No 575/2013 and Directive 2013/36/EU, and in order to provide for the resolvability of entities and groups, the Board shall instruct the national resolution authorities to limit, in accordance with Article 10(11)(b) of this Regulation, the extent to which other institutions hold liabilities eligible for a bail-in tool, save for liabilities that are held at entities that are part of the same group. 5. In exceptional circumstances, where the bail-in tool is applied, certain liabilities may be excluded or partially excluded from the application of the write-down or conversion powers where: (a) it is not possible to bail-in that liability within a reasonable time notwithstanding the good faith efforts of the relevant national resolution authority; (b) the exclusion is strictly necessary and is proportionate to achieve the continuity of critical functions and core business lines in a manner that maintains the ability of the institution under resolution to continue key operations, services and transactions; (c) the exclusion is strictly necessary and proportionate to avoid giving rise to widespread contagion, in particular as regards eligible deposits held by natural persons and micro, small and medium-sized enterprises, which would severely disrupt the functioning of financial markets, including of financial market infrastructures, in a manner that could cause a serious disturbance to the economy of a Member State or of the Union; or (d) the application of the bail-in tool to those liabilities would cause a destruction in value such that the losses borne by other creditors would be higher than if those liabilities were excluded from bail-in. Where an eligible liability or class of eligible liabilities is excluded or partially excluded under this paragraph, the level of write-down or conversion applied to other eligible liabilities may be increased to take account of such exclusions provided that the level of write-down and conversion applied to other eligible liabilities complies with the principle laid down in point (g) of Article 15(1). 6. Where an eligible liability or class of eligible liabilities is excluded or partially excluded pursuant to paragraph 5, and the losses that would have been borne by those liabilities have not been passed on fully to other creditors, a contribution from the Fund may be made to the institution under resolution to do one or both of the following: (a) cover any losses which have not been absorbed by eligible liabilities and restore the net asset value of the institution under resolution to zero in accordance with point (a) of paragraph 13; (b) purchase instruments of ownership or capital instruments in the institution under resolution, in order to recapitalise the institution in accordance with point (b) of paragraph 13. 7. The Fund may make a contribution referred to in paragraph 6 only where: (a) a contribution to loss absorption and recapitalisation equal to an amount not less than 8 % of the total liabilities including own funds of the institution under resolution, measured at the time of resolution action in accordance with the valuation provided for in Article 20(1) to (15), has been made by shareholders, the holders of relevant capital instruments and other eligible liabilities through write-down, conversion or otherwise; and (b) the contribution from the Fund does not exceed 5 % of the total liabilities including own funds of the institution under resolution, measured at the time of resolution action in accordance with the valuation provided for in Article 20(1) to (15). 8. The contribution of the Fund referred to in paragraph 7 of this Article may be financed by: (a) the amount available to the Fund which has been raised through contributions by entities referred to in Article 2 of this Regulation in accordance with the rules laid down in Directive 2014/59/EU and in Article 67(4) and Articles 70 and 71 of this Regulation; (b) where the amounts referred to in point (a) of this paragraph are insufficient, amounts raised from alternative funding means in accordance with Articles 73 and 74. 9. In extraordinary circumstances, further funding may be sought from alternative financing sources after: (a) the 5 % limit specified in point (b) of paragraph 7 has been reached; and (b) all unsecured, non-preferred liabilities, other than eligible deposits, have been written down or converted in full. 10. As an alternative or in addition, where the conditions laid down in points (a) and (b) of paragraph 9 are met, a contribution may be made from resources which have been raised through ex-ante contributions in accordance with Article 70 and which have not yet been used. 11. For the purposes of this Regulation, Article 44(8) of Directive 2014/59/EU shall not apply. 12. When taking the decision referred to in paragraph 5, due consideration shall be given to: (a) the principle that losses should be borne first by shareholders and next, in general, by creditors of the institution under resolution in order of preference; (b) the level of loss absorbing capacity that would remain in the institution under resolution if the liability or class of liabilities were excluded; and (c) the need to maintain adequate resources for resolution financing. 13. The Board shall assess, on the basis of a valuation that complies with the requirements of Article 20(1) to (15), the aggregate of: (a) where relevant, the amount by which eligible liabilities must be written down in order to ensure that the net asset value of the institution under resolution is equal to zero; and (b) where relevant, the amount by which eligible liabilities must be converted into shares or other types of capital instruments in order to restore the Common Equity Tier 1 capital ratio of either: (i) the institution under resolution; or (ii) the bridge institution. The assessment referred to in the first subparagraph shall establish the amount by which eligible liabilities need to be written down or converted in order to restore the Common Equity Tier 1 capital ratio of the institution under resolution, or, where applicable, establish the ratio of the bridge institution taking into account any contribution of capital by the Fund pursuant to point (d) of Article 76(1), and to sustain sufficient market confidence in the institution under resolution or the bridge institution and enable it to continue to meet, for at least one year, the conditions for authorisation and to continue to carry out the activities for which it is authorised under Directive 2013/36/EU or Directive 2014/65/EU. Where the Board intends to use the asset separation tool referred to in Article 26, the amount by which eligible liabilities need to be reduced shall take into account a prudent estimate of the capital needs of the asset management vehicle as appropriate. 14. Exclusions under paragraph 5 may be applied either to completely exclude a liability from write-down or to limit the extent of the write-down applied to that liability. 15. The write-down and conversion powers shall comply with the requirements on the priority of claims laid down in Article 17 of this Regulation. 16. The national resolution authority shall immediately submit to the Board the business reorganisation plan received in accordance with Article 52(1), (2) and (3) of Directive 2014/59/EU from the management body or the person or persons appointed in accordance with Article 72(1) thereof. Within two weeks from the date of submission of the business reorganisation plan, the relevant national resolution authority shall provide the Board with its assessment of the plan. Within one month from the date of submission of the business reorganisation plan, the Board shall assess the likelihood that the plan, if implemented, will restore the long term viability of an entity referred to in Article 2. The assessment shall be completed in agreement with the national competent authority or the ECB, where relevant. Where the Board is satisfied that the plan would achieve that objective, it shall allow the national resolution authority to approve the plan in accordance with Article 52(7) of Directive 2014/59/EU. Where the Board is not satisfied that the plan would achieve that objective, it shall instruct the national resolution authority to notify the management body or the person or persons appointed in accordance with Article 72(1) of that Directive of its concerns and require the amendment of the plan in a way that addresses those concerns in accordance with Article 52(8) of that Directive. In both cases this shall be done in agreement with the national competent authority or the ECB, where relevant. Within two weeks from the date of receipt of such a notification, the management body or the person or persons appointed in accordance with Article 72(1) of Directive 2014/59/EU shall submit an amended plan to the national resolution authority for approval. The national resolution authority shall submit to the Board the amended plan and its assessment of such plan. The Board shall assess the amended plan, and shall instruct the national resolution authority to notify the management body or the person or persons appointed in accordance with Article 72(1) of Directive 2014/59/EU within one week whether it is satisfied that the plan, as amended, addresses the concerns notified or whether further amendment is required. The Board shall communicate the group business reorganisation plan to EBA. Article 28 Monitoring by the Board 1. The Board shall closely monitor the execution of the resolution scheme by the national resolution authorities. For that purpose, the national resolution authorities shall: (a) cooperate with and assist the Board in the performance of its monitoring duty; (b) provide, at regular intervals established by the Board, accurate, reliable and complete information on the execution of the resolution scheme, the application of the resolution tools and the exercise of the resolution powers, that might be requested by the Board, including on the following: (i) the operation and financial situation of the institution under resolution, the bridge institution and the asset management vehicle; (ii) the treatment that shareholders and creditors would have received in the liquidation of the institution under normal insolvency proceedings; (iii) any ongoing court proceedings relating to the liquidation of the assets of the institution under resolution, to challenges to the resolution decision and to the valuation or relating to applications for compensation filed by the shareholders or creditors; (iv) the appointment, removal or replacement of evaluators, administrators, accountants, lawyers and other professionals that may be necessary to assist the national resolution authority, and on the performance of their duties; (v) any other matter that is relevant for the execution of the resolution scheme including any potential infringement of the safeguards provided for in Directive 2014/59/EU that may be referred to by the Board; (vi) the extent to which, and manner in which, the powers of the national resolution authorities referred to in Articles 63 to 72 of Directive 2014/59/EU are exercised by them; (vii) the economic viability, feasibility, and implementation of the business reorganisation plan provided for in Article 27(16). The national resolution authorities shall submit to the Board a final report on the execution of the resolution scheme. 2. On the basis of the information provided, the Board may give instructions to the national resolution authorities as to any aspect of the execution of the resolution scheme, and in particular the elements referred to in Article 23 and to the exercise of the resolution powers. 3. Where necessary in order to achieve the resolution objectives, the resolution scheme may be amended. The procedure laid down in Article 18 shall apply. Article 29 Implementation of decisions under this Regulation 1. National resolution authorities shall take the necessary action to implement decisions referred to in this Regulation, in particular by exercising control over the entities and groups referred to in Article 7(2), and the entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met, by taking the necessary measures in accordance with Article 35 or 72 of Directive 2014/59/EU and by ensuring that the safeguards provided for in that Directive are complied with. National resolution authorities shall implement all decisions addressed to them by the Board. For those purposes, subject to this Regulation, they shall exercise their powers under national law transposing Directive 2014/59/EU and in accordance with the conditions laid down in national law. National resolution authorities shall fully inform the Board of the exercise of those powers. Any action they take shall comply with the Board's decisions pursuant to this Regulation. When implementing those decisions, the national resolution authorities shall ensure that the applicable safeguards provided for in Directive 2014/59/EU are complied with. 2. Where a national resolution authority has not applied or has not complied with a decision by the Board pursuant to this Regulation or has applied it in a way which poses a threat to any of the resolution objectives under Article 14 or to the efficient implementation of the resolution scheme, the Board may order an institution under resolution: (a) in the event of action pursuant to Article 18, to transfer to another person specified rights, assets or liabilities of an institution under resolution; (b) in the event of action pursuant to Article 18, to require the conversion of any debt instruments which contain a contractual term for conversion in the circumstances provided for in Article 21; (c) to adopt any other necessary action to comply with the decision in question. The Board shall adopt a decision referred to in point (c) of the first subparagraph only if the measure significantly addresses the threat to the relevant resolution objective or to the efficient implementation of the resolution scheme. Before deciding to impose any measure the Board shall notify the national resolution authorities concerned and the Commission of the measure it intends to take. That notification shall include details of the envisaged measures, the reasons for those measures and details of when the measures are intended to take effect. The notification shall be made not less than 24 hours before the measures are to take effect. In exceptional circumstances where it is not possible to give 24 hours' notice, the Board may make the notification less than 24 hours before the measures are intended to take effect. 3. The institution under resolution shall comply with any decision taken referred to in paragraph 2. Those decisions shall prevail over any previous decision adopted by the national resolution authorities on the same matter. 4. When taking action in relation to issues which are subject to a decision taken pursuant to paragraph 2, national resolution authorities shall comply with that decision. 5. The Board shall publish on its official website either a copy of the resolution scheme or a notice summarising the effects of the resolution action, and in particular the effects on retail customers. The national resolution authorities shall comply with the applicable procedural obligations provided for in Article 83 of Directive 2014/59/EU. CHAPTER 4 Cooperation Article 30 Obligation to cooperate and information exchange within the SRM 1. The Board shall inform the Commission of any action it takes in order to prepare for resolution. With regard to any information received from the Board, the members of the Council, the Commission as well as the Council and the Commission staff shall be subject to the requirements of professional secrecy laid down in Article 88. 2. In the exercise of their respective responsibilities under this Regulation, the Board, the Council, the Commission, the ECB and the national resolution authorities and national competent authorities shall cooperate closely, in particular in the resolution planning, early intervention and resolution phases pursuant to Articles 8 to 29. They shall provide each other with all information necessary for the performance of their tasks. 3. The ECB or the national competent authorities shall transmit to the Board and the national resolution authorities the group financial support agreements authorised and any changes thereto. 4. For the purposes of this Regulation, the ECB may invite the Chair of the Board to participate as an observer in the Supervisory Board of the ECB established in accordance with Article 19 of Regulation (EU) No 1024/2013. Where deemed to be appropriate the Board may appoint another representative to replace the Chair for that purpose. 5. For the purposes of this Regulation, the Board shall appoint a representative which shall participate in the Resolution Committee of EBA established in accordance with Article 127 of Directive 2014/59/EU. 6. The Board shall endeavour to cooperate closely with any public financial assistance facility including the European Financial Stability Facility (EFSF) and the European Stability Mechanism (ESM), in particular in the extraordinary circumstances referred to in Article 27(9) and where such a facility has granted, or is likely to grant, direct or indirect financial assistance to entities established in a participating Member State. 7. Where necessary, the Board shall conclude a memorandum of understanding with the ECB and the national resolution authorities and the national competent authorities describing in general terms how they will cooperate under paragraphs 2 and 4 in the performance of their respective tasks under Union law. The memorandum shall be reviewed on a regular basis and shall be published subject to the requirements of professional secrecy. Article 31 Cooperation within the SRM 1. The Board shall perform its tasks in close cooperation with national resolution authorities. The Board shall, in cooperation with national resolution authorities, approve and make public a framework to organise the practical arrangements for the implementation of this Article. In order to ensure effective and consistent application of this Article, the Board: (a) shall issue guidelines and general instructions to national resolution authorities according to which the tasks are performed and resolution decisions are adopted by national resolution authorities; (b) may at any time exercise the powers referred to in Articles 34 to 37; (c) may request, on an ad hoc or continuous basis, information from national resolution authorities on the performance of the tasks carried out by them under Article 7(3); (d) shall receive from national resolution authorities draft decisions on which it may express its views, and, in particular, indicate the elements of the draft decision that do not comply with this Regulation or with the Board's general instructions. For the purposes of evaluating resolution plans, the Board may request national resolution authorities to submit to the Board all information necessary, as obtained by them in accordance with Article 11 and Article 13(1) of Directive 2014/59/EU, without prejudice to Chapter 5 of this Title. 2. Article 13(4) to (10) and Articles 88 to 92 of Directive 2014/59/EU shall not apply to relations between national resolution authorities. The joint decision and any decision taken in the absence of a joint decision as referred to in Article 45(9) to (13) of Directive 2014/59/EU shall not apply. The relevant provisions of this Regulation shall apply instead. Article 32 Consultation of, and cooperation with, non-participating Member States and third countries 1. Where a group includes entities established in participating Member States as well as in non-participating Member States or third countries, without prejudice to any approval by the Council or the Commission required under this Regulation, the Board shall represent the national resolution authorities of the participating Member States for the purposes of consultation and cooperation with non-participating Member States or third countries in accordance with Articles 7, 8, 12, 13, 16, 18, 55, and 88 to 92 of Directive 2014/59/EU. Where a group includes entities established in participating Member States and subsidiaries established, or significant branches located, in non-participating Member States, the Board shall communicate any plans, decisions or measures referred to in Articles 8, 10, 11, 12 and 13 relevant to the group to the competent authorities and/or the resolution authorities of the non-participating Member State, as appropriate. 2. The Board, the ECB and the resolution authorities and competent authorities of the non-participating Member States shall conclude memoranda of understanding describing in general terms how they will cooperate with one another in the performance of their tasks under Directive 2014/59/EU. Without prejudice to the first subparagraph, the Board shall conclude a memorandum of understanding with the resolution authority of each non-participating Member State that is home to at least one global systemically important institution, identified as such pursuant to Article 131 of Directive 2013/36/EU. 3. Each memorandum shall be reviewed on a regular basis and shall be published subject to the requirements of professional secrecy. 4. The Board shall conclude, on behalf of the national resolution authorities of participating Member States, non-binding cooperation arrangements in line with the EBA framework cooperation arrangements referred to in Article 97(2) of Directive 2014/59/EU. The Board shall notify EBA of any such cooperation arrangement. Article 33 Recognition and enforcement of third-country resolution proceedings 1. This Article shall apply in respect of third-country resolution proceedings unless and until an international agreement as referred to in Article 93(1) of Directive 2014/59/EU enters into force with the relevant third country. It shall also apply following the entry into force of an international agreement as referred to in Article 93(1) of that Directive with the relevant third country to the extent that recognition and enforcement of third-country resolution proceedings is not governed by that agreement. 2. The Board shall assess and issue a recommendation addressed to the national resolution authorities on the recognition and enforcement of resolution proceedings conducted by third-country resolution authorities in relation to a third-country institution or a third-country parent undertaking that has: (a) one or more Union subsidiaries established in one or more participating Member States; or (b) assets, rights or liabilities located in one or more participating Member States or governed by the law of participating Member States. The Board shall conduct its assessment, after consulting the national resolution authorities and, where a European resolution college is established pursuant to Article 89 of Directive 2014/59/EU, with the resolution authorities of non-participating Member States. The assessment shall give due consideration to the interests of each individual participating Member State where a third-country institution or parent undertaking operates, and in particular to the potential impact of the recognition and enforcement of the third-country resolution proceedings on the other parts of the group and the financial stability in those Member States. 3. The Board shall recommend to refuse the recognition or enforcement of the resolution proceedings referred to in paragraph 1, if it considers that: (a) the third-country resolution proceedings would have an adverse effect on financial stability in a participating Member State; (b) creditors, including in particular depositors located or payable in a participating Member State, would not receive the same treatment as third-country creditors and depositors with similar legal rights under the third-country home resolution proceedings; (c) recognition or enforcement of the third-country resolution proceedings would have material fiscal implications for the participating Member State; or (d) the effects of such recognition or enforcement would be contrary to the national law of the participating Member State. 4. National resolution authorities shall implement the recommendation of the Board and ask for the recognition or enforcement of the resolution proceedings in their respective territories, or shall explain in a reasoned statement to the Board why they cannot implement the recommendation of the Board. 5. When exercising resolution powers in relation to third-country entities, national resolution authorities shall, where relevant, exercise the powers conferred on them on the basis of the provisions referred to in Article 94(4) of Directive 2014/59/EU. CHAPTER 5 Investigatory powers Article 34 Requests for information 1. For the purpose of performing its tasks under this Regulation, the Board may, through the national resolution authorities or directly, after informing them, making full use of all of the information available to the ECB or to the national competent authorities, require the following legal or natural persons to provide all of the information necessary to perform the tasks conferred on it by this Regulation: (a) the entities referred to in Article 2; (b) employees of the entities referred to in Article 2; (c) third parties to whom the entities referred to in Article 2 have outsourced functions or activities. 2. The entities and persons referred to in paragraph 1 shall supply the information requested pursuant to that paragraph. The requirements of professional secrecy shall not exempt those entities and persons from the duty to supply that information. The supply of the information requested shall not be deemed to infringe the requirements of professional secrecy. 3. Where the Board obtains information directly from those entities and persons, it shall make that information available to the national resolution authorities concerned. 4. The Board shall be able to obtain, including on a continuous basis, any information necessary for the exercise of its functions under this Regulation, in particular on capital, liquidity, assets and liabilities concerning any institution subject to its resolution powers. 5. The Board, the ECB, the national competent authorities and the national resolution authorities may draw up memoranda of understanding with a procedure concerning the exchange of information. The exchange of information between the Board, the ECB, the national competent authorities and the national resolution authorities shall not be deemed to infringe the requirements of professional secrecy. 6. National competent authorities, the ECB where relevant, and national resolution authorities shall cooperate with the Board in order to verify whether some or all of the information requested is already available. Where such information is available, national competent authorities, the ECB where relevant, or national resolution authorities shall provide that information to the Board. Article 35 General investigations 1. For the purpose of performing its tasks under this Regulation, and subject to any other conditions laid down in relevant Union law, the Board may, through the national resolution authorities or directly, after informing them, conduct all necessary investigations of any legal or natural person referred to in Article 34(1) established or located in a participating Member State. To that end, the Board may: (a) require the submission of documents; (b) examine the books and records of any legal or natural person referred to in Article 34(1) and take copies or extracts from such books and records; (c) obtain written or oral explanations from any legal or natural person referred to in Article 34(1) or their representatives or staff; (d) interview any other natural or legal person who consents to be interviewed for the purpose of collecting information relating to the subject matter of an investigation. 2. The natural or legal persons referred to in Article 34(1) shall be subject to investigations launched on the basis of a decision of the Board. Where a person obstructs the conduct of the investigation, the national resolution authorities of the participating Member State where the relevant premises are located shall afford, in accordance with national law, the necessary assistance including facilitating the access by the Board to the business premises of the natural or legal persons referred to in Article 34(1), so that those rights can be exercised. Article 36 On-site inspections 1. For the purpose of performing its tasks under this Regulation, and subject to other conditions laid down in relevant Union law, the Board may, in accordance with Article 37 and subject to prior notification to the national resolution authorities and the relevant national competent authorities concerned, and, where appropriate, in cooperation with them, conduct all necessary on-site inspections at the business premises of the natural or legal persons referred to in Article 34(1). Where the proper conduct and efficiency of the inspection so require, the Board may carry out the on-site inspection without prior announcement to those legal persons. 2. The officials of and other persons authorised by the Board to conduct an on-site inspection may enter any business premises and land of the legal persons subject to an investigation decision adopted by the Board pursuant to Article 35(2) and shall have all of the powers referred to in Article 35(1). 3. The legal persons referred to in Article 34(1) shall be subject to on-site inspections on the basis of a decision of the Board. 4. Officials of, and other accompanying persons authorised or appointed by, the national resolution authorities of the Member States where the inspection is to be conducted shall, under the supervision and coordination of the Board, actively assist the officials of, and other persons authorised by, the Board. To that end, they shall enjoy the powers referred to in paragraph 2. Officials of, and other accompanying persons authorised or appointed by, the national resolution authorities of the participating Member States concerned shall also have the right to participate in the on-site inspections. 5. Where the officials of and other accompanying persons authorised or appointed by the Board find that a person opposes an inspection ordered pursuant to paragraph 1, the national resolution authorities of the participating Member States concerned shall afford them the necessary assistance in accordance with national law. To the extent necessary for the inspection, that assistance shall include the sealing of any business premises and books or records. Where that power is not available to the national resolution authorities concerned, it shall exercise its powers to request the necessary assistance of other national authorities. Article 37 Authorisation by a judicial authority 1. If an on-site inspection provided for in Article 36(1) and (2) or the assistance provided for in Article 36(5) requires authorisation by a judicial authority in accordance with national rules, such authorisation shall be applied for. 2. Where authorisation as referred to in paragraph 1 of this Article is applied for, the national judicial authority shall control that the decision of the Board is authentic and that the coercive measures envisaged are neither arbitrary nor excessive, taking into account the subject matter of the inspection. In its control of the proportionality of the coercive measures, the national judicial authority may ask the Board for detailed explanations, in particular relating to the grounds the Board has for suspecting that an infringement of the decisions referred to in Article 29 has taken place, the seriousness of the suspected infringement and the nature of the involvement of the person subject to the coercive measures. However, the national judicial authority shall not review the necessity for the inspection or demand to be provided with the information on the Board's file. The lawfulness of the Board's decision shall be subject to review only by the Court of Justice. CHAPTER 6 Penalties Article 38 Fines 1. Where the Board finds that an entity referred to in Article 2 has intentionally or negligently committed one of the infringements listed in paragraph 2, the Board shall take a decision imposing a fine in accordance with paragraph 3. An infringement by such an entity shall be considered to have been committed intentionally if there are objective factors which demonstrate that the entity or its management body or senior management acted deliberately to commit the infringement. 2. The fines shall be imposed on entities referred to in Article 2 for the following infringements: (a) where they do not supply the information requested in accordance with Article 34; (b) where they do not submit to a general investigation in accordance with Article 35 or an on-site inspection in accordance with Article 36; (c) where they do not comply with a decision addressed to them by the Board pursuant to Article 29. 3. The basic amount of the fines referred to in paragraph 1 of this Article shall be a percentage of the total annual net turnover including the gross income consisting of interest receivable and similar income, income from shares and other variable or fixed-yield securities, and commissions or fees receivable in accordance with Article 316 of Regulation (EU) No 575/2013 of the undertaking in the preceding business year, or, in the Member States whose currency is not the euro, the corresponding value in the national currency on 19 August 2014, and included within the following limits: (a) for the infringements referred to in paragraph 2(a) and (b), the basic amount shall amount to at least 0,05 % and shall not exceed 0,15 %; (b) for the infringements referred to in paragraph 2(c), the basic amount shall amount to at least 0,25 % and shall not exceed 0,5 %. In order to decide whether the basic amount of the fines should be set at the lower, the middle or the higher end of the limits referred to in the first subparagraph, the Board shall take into account the annual turnover in the preceding business year of the entity concerned. The basic amount shall be at the lower end of the limit for entities whose annual turnover is below EUR 1 000 000 000, the middle of the limit for the entities whose annual turnover is between EUR 1 000 000 000 and 5 000 000 000 and the higher end of the limit for the entities whose annual turnover is higher than EUR 5 000 000 000. 4. The basic amounts referred to in paragraph 3 shall be adjusted, if necessary, by taking into account the aggravating or mitigating factors referred to in paragraphs 5 and 6, in accordance with the relevant coefficients referred to in paragraph 9. The relevant mitigating coefficient shall be applied one by one to the basic amount. If more than one mitigating coefficient is applicable, the difference between the basic amount and the amount resulting from the application of each individual mitigating coefficient shall be subtracted from the basic amount. The relevant aggravating coefficient shall be applied one by one to the basic amount. If more than one aggravating coefficient is applicable, the difference between the basic amount and the amount resulting from the application of each individual aggravating coefficient shall be added to the basic amount. 5. The following aggravating factors shall apply in respect of the fines referred to in paragraph 1: (a) the infringement has been committed intentionally; (b) the infringement has been committed repeatedly; (c) the infringement has been committed over a period exceeding three months; (d) the infringement has revealed systemic weaknesses in the organisation of the entity, in particular in its procedures, management systems or internal controls; (e) no remedial action has been taken since the infringement was identified; (f) the entity's senior management has not cooperated with the Board in carrying out its investigations. 6. The following mitigating factors shall apply in respect of the fines referred to in paragraph 1: (a) the infringement has been committed over a period of less than 10 working days; (b) the entity's senior management can demonstrate that they have taken all measures necessary to prevent the infringement; (c) the entity has brought quickly, effectively and completely the infringement to the Board's attention; (d) the entity has voluntarily taken measures to ensure that a similar infringement cannot be committed in the future. 7. Notwithstanding paragraphs 2 to 6, the fines applied shall not exceed 1 % of the annual turnover of the entity referred to in paragraph 1 concerned in the preceding business year. By way of derogation from the first subparagraph, where the entity has directly or indirectly benefited financially from that infringement and where profits gained or losses avoided because of the infringement can be determined, the fine shall be at least equal to that financial benefit. Where an act or omission of an entity referred to in paragraph 1 constitutes more than one infringement listed in paragraph 2, only the higher fine calculated in accordance with this Article and relating to one of those infringements shall apply. 8. In the cases not covered by paragraph 2, the Board may recommend to national resolution authorities to take action in order to ensure that appropriate penalties are imposed in accordance with Articles 110 to 114 of Directive 2014/59/EU and with any relevant national legislation. 9. The Board shall apply the following adjustment coefficients linked to aggravating factors when calculating the fines: (a) if the infringement has been committed repeatedly, for every time it has been repeated, an additional coefficient of 1,1 shall apply; (b) if the infringement has been committed over a period exceeding three months, a coefficient of 1,5 shall apply; (c) if the infringement has revealed systemic weaknesses in the organisation of the entity, in particular in its procedures, management systems or internal controls, a coefficient of 2,2 shall apply; (d) if the infringement has been committed intentionally, a coefficient of 2 shall apply; (e) if no remedial action has been taken since the infringement was identified, a coefficient of 1,7 shall apply; (f) if the entity's senior management has not cooperated with the Board in carrying out its investigations, a coefficient of 1,5 shall apply. The Board shall apply the following adjustment coefficients linked to mitigating factors when calculating the fines: (a) if the infringement has been committed over a period of less than 10 working days, a coefficient of 0,9 shall apply; (b) if the entity's senior management can demonstrate that they have taken all measures necessary to prevent the infringement, a coefficient of 0,7 shall apply; (c) if the entity has brought quickly, effectively and completely the infringement to the Board's attention, a coefficient of 0,4 shall apply; (d) if the entity has voluntarily taken measures to ensure that a similar infringement cannot be committed in the future, a coefficient of 0,6 shall apply. Article 39 Periodic penalty payments 1. The Board shall, by a decision, impose a periodic penalty payment in respect of an entity referred to in Article 2 in order to compel: (a) that entity to comply with a decision adopted under Article 34; (b) a person referred to in Article 34(1) to supply complete information which has been required by a decision pursuant to that Article; (c) a person referred to in Article 35(1) to submit to an investigation and, in particular, to produce complete records, data, procedures or any other material required and to complete and correct other information provided in an investigation launched by a decision taken pursuant to that Article; (d) a person referred to in Article 36(1) to submit to an on-site inspection ordered by a decision taken pursuant to that Article. 2. A periodic penalty payment shall be effective and proportionate. A periodic penalty payment shall be imposed on a daily basis until the entity referred to in Article 2 or person concerned complies with the relevant decisions referred to in points (a) to (d) of paragraph 1 of this Article. 3. Notwithstanding paragraph 2, the amount of a periodic penalty payment shall be 0,1 % of the average daily turnover in the preceding business year. A periodic penalty payment shall be calculated from the date stipulated in the decision imposing the periodic penalty payment. 4. A periodic penalty payment may be imposed for a period of no more than six months following the notification of the Board's decision. Article 40 Hearing of the persons subject to the proceedings 1. Before taking any decision imposing a fine and/or periodic penalty payment under Article 38 or 39, the Board shall give the natural or legal persons subject to the proceedings the opportunity to be heard on its findings. The Board shall base its decisions only on findings on which the natural or legal persons subject to the proceedings have had the opportunity to comment. 2. The rights of defence of the natural or legal persons subject to the proceedings shall be fully complied with during the proceedings. They shall be entitled to have access to the Board's file, subject to the legitimate interest of other persons in the protection of their business secrets. The right of access to the file shall not extend to confidential information or internal preparatory documents of the Board. Article 41 Disclosure, nature, enforcement and allocation of fines and periodic penalty payments 1. The Board shall publish the decisions imposing penalties referred to in Article 38(1) and Article 39(1), unless such disclosure could endanger the resolution of the entity concerned. The publication shall be on an anonymous basis, in any of the following circumstances: (a) where the information published contains personal data and following an obligatory prior assessment, such publication of personal data is found to be disproportionate; (b) where publication would jeopardise the stability of financial markets or an ongoing criminal investigation; (c) where publication would cause, insofar as it can be determined, disproportionate damage to the natural or legal persons involved. Alternatively, in such cases, the publication of the data in question may be postponed for a reasonable period if it is foreseeable that the reasons for anonymous publication will cease to exist within that period. The Board shall inform EBA of all fines and periodic penalty payments imposed by it under Articles 38 and 39 and shall provide information on the appeal status and outcome thereof. 2. Fines and periodic penalty payments imposed pursuant to Articles 38 and 39 shall be of an administrative nature. 3. Fines and periodic penalty payments imposed pursuant to Articles 38 and 39 shall be enforceable. Enforcement shall be governed by the applicable procedural rules in force in the participating Member State in the territory of which it is carried out. The order for its enforcement shall be appended to the decision without any other formality than verification of the authenticity of the decision by the authority which the government of each participating Member State shall designate for that purpose and which it shall make known to the Board and to the Court of Justice. When those formalities have been completed on application by the party concerned, the latter may proceed to enforcement in accordance with the national law, by bringing the matter directly before the competent body. Enforcement may be suspended only by a decision of the Court of Justice. However, the courts of the participating Member State concerned shall have jurisdiction over complaints that enforcement is being carried out in an irregular manner. 4. The amounts of the fines and periodic penalty payments shall be allocated to the Fund. PART III INSTITUTIONAL FRAMEWORK TITLE I THE BOARD Article 42 Legal status 1. The Board is hereby established. The Board shall be a Union agency with a specific structure corresponding to its tasks. It shall have legal personality. 2. In each Member State, the Board shall enjoy the most extensive legal capacity accorded to legal persons under national law. It may, in particular, acquire or dispose of movable and immovable property and be a party to legal proceedings. 3. The Board shall be represented by its Chair. Article 43 Composition 1. The Board shall be composed of: (a) the Chair appointed in accordance with Article 56; (b) four further full-time members appointed in accordance with Article 56; (c) a member appointed by each participating Member State, representing their national resolution authorities. 2. Each member, including the Chair, shall have one vote. 3. The Commission and the ECB shall each designate a representative entitled to participate in the meetings of executive sessions and plenary sessions as a permanent observer. The representatives of the Commission and the ECB shall be entitled to participate in the debates and shall have access to all documents. 4. In the event of more than one national resolution authority in a participating Member State, a second representative shall be allowed to participate as observer without voting rights. 5. The Board's administrative and management structure shall comprise: (a) a plenary session of the Board, which shall perform the tasks referred to in Article 50; (b) an executive session of the Board, which shall perform the tasks referred to in Article 54; (c) a Chair, which shall perform the tasks referred to in Article 56; (d) a Secretariat, which shall provide the necessary administrative and technical support on the performing of all the tasks assigned to the Board. Article 44 Compliance with Union law The Board shall act in compliance with Union law, in particular with the Council and the Commission decisions pursuant to this Regulation. Article 45 Accountability 1. The Board shall be accountable to the European Parliament, the Council and the Commission for the implementation of this Regulation, in accordance with paragraphs 2 to 8. 2. The Board shall submit an annual report to the European Parliament, the national parliaments of participating Member States in accordance with Article 46, the Council, the Commission and the European Court of Auditors on the performance of the tasks conferred on it by this Regulation. Subject to the requirements of professional secrecy, that report shall be published on the Board's website. 3. The Chair shall present that report in public to the European Parliament, and to the Council. 4. At the request of the European Parliament, the Chair shall participate in a hearing by the competent committee of the European Parliament on the performance of the resolution tasks by the Board. A hearing shall take place at least annually. 5. The Chair may be heard by the Council, at the Council's request, on the performance of the resolution tasks by the Board. 6. The Board shall reply orally or in writing to questions addressed to it by the European Parliament or by the Council, in accordance with its own procedures and in any event within five weeks of receipt of a question. 7. Upon request, the Chair shall hold confidential oral discussions behind closed doors with the Chair and Vice-Chairs of the competent committee of the European Parliament where such discussions are required for the exercise of the European Parliament's powers under the TFEU. An agreement shall be concluded between the European Parliament and the Board on the detailed modalities of organising such discussions, with a view to ensuring full confidentiality in accordance with the requirements of professional secrecy imposed on the Board by this Regulation and when the Board is acting as a national resolution authority under the relevant Union law. 8. During any investigations by the European Parliament, the Board shall cooperate with the European Parliament, subject to the TFEU and regulations referred to in Article 226 thereof. Within six months of the appointment of the Chair, the Board and the European Parliament shall conclude appropriate arrangements on the practical modalities of the exercise of democratic accountability and oversight over the exercise of the tasks conferred on the Board by this Regulation. Subject to the power of the European Parliament pursuant to Article 226 TFEU, those arrangements shall cover, inter alia, access to information, including rules on the handling and protection of classified or otherwise confidential information, cooperation in hearings, as referred to in Article 45(4) of this Regulation, confidential oral discussions, reports, responding to questions, investigations and information on the selection procedure of the Chair, the Vice-Chair, and the four members referred to in Article 43(1)(b) of this Regulation. Article 46 National parliaments 1. Due to the specific tasks that are conferred on the Board by this Regulation, national parliaments of the participating Member States, by means of their own procedures, may request the Board to reply and the Board is obliged to reply in writing to any observations or questions submitted by them to the Board in respect of the functions of the Board under this Regulation. 2. When submitting the report provided for in Article 45(2), the Board shall simultaneously submit that report directly to the national parliaments of the participating Member States. National parliaments may address to the Board their reasoned observations on that report. The Board shall reply orally or in writing to any observations or questions addressed to it by the national parliaments of the participating Member States, in accordance with its own procedures. 3. The national parliament of a participating Member State may invite the Chair to participate in an exchange of views in relation to the resolution of entities referred to in Article 2 in that Member State together with a representative of the national resolution authority. The Chair is obliged to follow such invitation. 4. This Regulation shall be without prejudice to the accountability of national resolution authorities to national parliaments in accordance with national law for the performance of tasks not conferred on the Board, the Council or the Commission by this Regulation and for the performance of activities carried out by them in accordance with Article 7(3). Article 47 Independence 1. When performing the tasks conferred on them by this Regulation, the Board and the national resolution authorities shall act independently and in the general interest. 2. The Chair, the Vice-Chair and the members referred to in Article 43(1)(b) shall perform their tasks in conformity with the decisions of the Board, the Council and the Commission. They shall act independently and objectively in the interest of the Union as a whole and shall neither seek nor take instructions from the Union's institutions or bodies, from any government of a Member State or from any other public or private body. In the deliberations and decision-making processes within the Board, they shall express their own views and vote independently. 3. Neither the Member States, the Union's institutions or bodies, nor any other public or private body shall seek to influence the Chair, the Vice-Chair or the members of the Board. 4. In accordance with the Staff Regulations of Officials as laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 (19) (the \u2018Staff Regulations\u2019) referred to in Article 87(6) of this Regulation, the Chair, the Vice-Chair and the members referred to in Article 43(1)(b) of this Regulation shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits. Article 48 Seat The Board shall have its seat in Brussels, Belgium. TITLE II PLENARY SESSION OF THE BOARD Article 49 Participation in plenary sessions All members of the Board referred to in Article 43(1) shall participate in its plenary sessions. Article 50 Tasks 1. In its plenary session, the Board shall: (a) adopt, by 30 November each year, the Board's annual work programme for the following year, based on a draft put forward by the Chair and shall transmit it for information to the European Parliament, the Council, the Commission, and the ECB; (b) adopt and monitor the annual budget of the Board in accordance with Article 61(2), and approve the Board's final accounts and give discharge to the Chair in accordance with Article 63(4) and (8); (c) subject to the procedure referred to in paragraph 2, decide on the use of the Fund, if the support of the Fund in that specific resolution action is required above the threshold of EUR 5 000 000 000 for which the weighting of liquidity support is 0,5; (d) once the net accumulated use of the Fund in the last consecutive 12 months reaches the threshold of EUR 5 000 000 000, evaluate the application of the resolution tools, in particular the use of the Fund, and provide guidance which the executive session shall follow in subsequent resolution decisions, in particular, if appropriate, differentiating between liquidity and other forms of support; (e) decide on the necessity to raise extraordinary ex-post contributions in accordance with Article 71, on the voluntary borrowing between financing arrangements in accordance with Article 72, on alternative financing means in accordance with Articles 73 and 74, and on the mutualisation of national financing arrangements in accordance with Article 78, involving support of the Fund above the threshold referred to in point (c) of this paragraph; (f) decide on the investments in accordance with Article 75; (g) adopt the annual activity report on the Board's activities referred to in Article 45, which shall present detailed explanations on the implementation of the budget; (h) adopt the financial rules applicable to the Board in accordance with Article 64; (i) adopt an anti-fraud strategy, proportionate to fraud risks taking into account the costs and benefits of the measures to be implemented; (j) adopt rules for the prevention and management of conflicts of interest in respect of its members; (k) adopt its rules of procedure and those of the Board in its executive session; (l) in accordance with paragraph 3 of this Article, exercise, with respect to the staff of the Board, the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment of Other Servants of the European Union as laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 (\u2018Conditions of Employment\u2019) on the Authority Empowered to Conclude a Contract of Employment (\u2018the appointing authority powers\u2019); (m) adopt appropriate implementing rules for giving effect to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations; (n) appoint an Accounting Officer, subject to the Staff Regulations and the Conditions of Employment, who shall be functionally independent in the performance of his or her duties; (o) ensure adequate follow-up to findings and recommendations stemming from the internal or external audit reports and evaluations, as well as from investigations of the European Anti-Fraud Office (OLAF); (p) take all decisions on the establishment of the Board's internal structures and, where necessary, their modification; (q) approve the framework referred to in Article 31(1) to organise the practical arrangements for the cooperation with the national resolution authorities. 2. When taking decisions, the plenary session of the Board shall act in accordance with the objectives as specified in Articles 6 and 14. For the purposes of point (c) of paragraph 1, the resolution scheme prepared by the executive session is deemed to be adopted unless, within three hours from the submission of the draft by the executive session to the plenary session, at least one member of the plenary session has called a meeting of the plenary session. In the latter case, a decision on the resolution scheme shall be taken by the plenary session. 3. In its plenary session, the Board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment, delegating relevant appointing authority powers to the Chair and establishing the conditions under which the delegation of powers can be suspended. The Chair shall be authorised to sub-delegate those powers. In exceptional circumstances, the Board in its plenary session may by way of a decision temporarily suspend the delegation of the appointing authority powers to the Chair and any sub-delegation by the latter and exercise them itself or delegate them to one of its members or to a staff member other than the Chair. Article 51 Meeting of the plenary session of the Board 1. The Chair shall convene and chair meetings of the plenary session of the Board in accordance with Article 56(2)(a). 2. The Board in its plenary session shall hold at least two ordinary meetings per year. In addition, it shall meet on the initiative of the Chair, or at the request of at least one-third of its members. The representative of the Commission may request the Chair to convene a meeting of the Board in its plenary session. The Chair shall provide reasons in writing if he or she does not convene a meeting in due time. 3. Where relevant, the Board may invite observers in addition to those referred in Article 43(3) to participate in the meetings of its plenary session on an ad hoc basis, including a representative of EBA. 4. The Board shall provide for the secretariat of the plenary session of the Board. Article 52 General provisions on the decision-making process 1. The Board, in its plenary session, shall take its decisions by a simple majority of its members, unless otherwise provided for in this Regulation. Each voting member shall have one vote. In the event of a tie, the Chair shall have a casting vote. 2. By way of derogation from paragraph 1, decisions referred to in Article 50(1)(c) and (d) as well as on the mutualisation of national financing arrangements in accordance with Article 78, limited to the use of the financial means available in the Fund, shall be taken by a simple majority of the Board members, representing at least 30 % of contributions. Each voting member shall have one vote. In the event of a tie, the Chair shall have a casting vote. 3. By way of derogation from paragraph 1 of this Article, decisions referred to in Article 50(1), which involve the raising of ex-post contributions in accordance with Article 71, on voluntary borrowing between financing arrangements in accordance with Article 72, on alternative financing means in accordance with Article 73 and Article 74, as well as on the mutualisation of national financing arrangements in accordance with Article 78, exceeding the use of the financial means available in the Fund, shall be taken by a majority of two thirds of the Board members, representing at least 50 % of contributions during the eight-year transitional period until the Fund is fully mutualised and by a majority of two thirds of the Board members, representing at least 30 % of contributions from then on. Each voting member shall have one vote. In the event of a tie, the Chair shall have a casting vote. 4. The Board shall adopt and make public its rules of procedure. The rules of procedure shall establish more detailed voting arrangements, in particular the circumstances in which a member may act on behalf of another member and including, where appropriate, the rules governing quorums. TITLE III EXECUTIVE SESSION OF THE BOARD Article 53 Participation in the executive sessions 1. The Board in its executive session is composed of the Chair and the four members referred to in Article 43(1)(b). The Board, in its executive session, shall meet as often as necessary. Meetings of the Board in its executive session shall be convened by the Chair on his or her own initiative or at the request of any of the members, and shall be chaired by the Chair. Where relevant, the Board in its executive session may invite observers in addition to those referred to in Article 43(3), including a representative of EBA, and shall invite national resolution authorities of non-participating Member States, when deliberating on a group that has subsidiaries or significant branches in those non-participating Member States, to participate at its meetings. The participation shall be on an ad hoc basis. 2. In accordance with paragraphs 3 and 4, the members of the Board referred to in Article 43(1)(c) shall participate in the executive sessions of the Board. 3. When deliberating on an entity referred to in Article 2 or a group of entities established only in one participating Member State, the member appointed by that Member State shall also participate in the deliberations and in the decision-making process, and the rules laid down in Article 55(1) shall apply. 4. When deliberating on a cross-border group, the member appointed by the Member State in which the group-level resolution authority is situated, as well as the members appointed by the Member States in which a subsidiary or entity covered by consolidated supervision is established, shall also participate in the decision-making process, and the rules laid down in Article 55(2) shall apply. 5. The members of the Board referred to in Article 43(1)(a) and (b) shall ensure that the resolution decisions and actions, in particular with regard to the use of the Fund, across the different formations of the executive sessions of the Board are coherent, appropriate and proportionate. Article 54 Tasks 1. The Board, in its executive session, shall: (a) prepare all of the decisions to be adopted by the Board in its plenary session; (b) take all of the decisions to implement this Regulation, unless this Regulation provides otherwise. 2. In exercising its duties pursuant to paragraph 1 of this Article, the Board shall: (a) prepare, assess and approve resolution plans for entities and groups referred to in Article 7(2), and for the entities and groups referred to in Article 7(4)(b) and (5), where the conditions for the application of those paragraphs are met, in accordance with Articles 8, 10 and 11; (b) apply simplified obligations to certain entities and groups referred to in Article 7(2), and entities and groups referred to in Article 7(4)(b) and (5), where the conditions for the application of those paragraphs are met, in accordance with Article 11; (c) determine the minimum requirement for own funds and eligible liabilities that entities and groups referred to in Article 7(2), and entities and groups referred to in Article 7(4)(b) and (5), where the conditions for the application of those paragraphs are met, need to meet at all times in accordance with Article 12; (d) provide the Commission, as early as possible, with a resolution scheme in accordance with Article 18 accompanied by all relevant information allowing in due time the Commission to assess and decide or, where appropriate, propose a decision to the Council, pursuant to Article 18(7); (e) decide upon the Board's part II of the budget on the Fund, in accordance with Article 60. 3. Where necessary because of urgency, the Board in its executive session may take certain provisional decisions on behalf of the Board in its plenary session, in particular on administrative management matters, including budgetary matters. 4. The Board in its executive session shall keep the Board in its plenary session informed of the decisions it takes on resolution. Article 55 Decision-making 1. When deliberating on an individual entity or a group established only in one participating Member State, if all members referred to in Article 53(1) and (3) are not able to reach a joint agreement by consensus within a deadline set by the Chair, the Chair and the members referred to in Article 43(1)(b) shall take a decision by a simple majority. 2. When deliberating on a cross-border group, if all members referred to in Article 53(1) and (4) are not able to reach a joint agreement by consensus within a deadline set by the Chair, the Chair and the members referred to in Article 43(1)(b) shall take a decision by a simple majority. 3. In the event of a tie, the Chair shall have a casting vote. TITLE IV CHAIR Article 56 Appointment and tasks 1. The Board shall be chaired by a full-time Chair. 2. The Chair shall be responsible for: (a) preparing the work of the Board, in its plenary and executive sessions, and convening and chairing its meetings; (b) all staff matters; (c) matters of day-to-day administration; (d) the establishment of a draft budget of the Board in accordance with Article 61(1) and the implementation of the budget of the Board, in accordance with Article 63; (e) the management of the Board; (f) the implementation of the annual work programme of the Board; (g) the preparation, each year, of a draft of the annual report referred to in Article 45 with a section on the resolution activities of the Board and a section on financial and administrative matters. In the performance of the tasks referred to in this Article, the Chair shall be assisted by a dedicated staff. 3. The Chair shall be assisted by a Vice-Chair. The Vice-Chair shall carry out the functions of the Chair in his or her absence or reasonable impediment, in accordance with this Regulation. 4. The Chair, the Vice-Chair and the members referred to in Article 43(1)(b) shall be appointed on the basis of merit, skills, knowledge of banking and financial matters, and of experience relevant to financial supervision, regulation as well as bank resolution. The Chair, the Vice-Chair and the members referred to in Article 43(1)(b) shall be chosen on the basis of an open selection procedure, which shall respect the principles of gender balance, experience and qualification. The European Parliament and the Council shall be kept duly informed at every stage of that procedure in a timely manner. 5. The term of office of the Chair, of the Vice-Chair and of the members referred to in Article 43(1)(b) shall be five years. Subject to paragraph 7 of this Article, that term shall not be renewable. The Chair, the Vice-Chair and the members referred to in Article 43(1)(b) shall not hold office at national, Union, or international level. 6. After hearing the Board, in its plenary session, the Commission shall provide to the European Parliament a shortlist of candidates for the positions of Chair, Vice-Chair and members referred to in Article 43(1)(b) and inform the Council of the shortlist. By way of derogation from the first subparagraph, for the appointment of the first members of the Board following the entry into force of this Regulation, the Commission shall provide the shortlist of candidates without hearing the Board. The Commission shall submit a proposal for the appointment of the Chair, the Vice-Chair and the members referred to in Article 43(1)(b) to the European Parliament for approval. Following the approval of that proposal, the Council shall adopt an implementing decision to appoint the Chair, the Vice-Chair and the members referred to in Article 43(1)(b). The Council shall act by qualified majority. 7. By way of derogation from paragraph 5, the term of office of the first Chair appointed after the entry into force of this Regulation shall be three years. That term shall be renewable once for a period of five years. The Chair, the Vice-Chair, and the members referred to in Article 43(1)(b) shall remain in office until their successors are appointed. 8. A Chair whose term of office has been extended shall not participate in another selection procedure for the same post at the end of the overall period. 9. If the Chair or the Vice-Chair or a member referred to in Article 43(1)(b) no longer fulfil the conditions required for the performance of his or her duties or has been guilty of serious misconduct, the Council may, on a proposal from the Commission which has been approved by the European Parliament, adopt an implementing decision to remove him or her from office. The Council shall act by qualified majority. For those purposes, the European Parliament or the Council may inform the Commission that it considers the conditions for the removal of the Chair, the Vice-Chair or the members referred to in Article 43(1)(b) from office to be fulfilled, to which the Commission shall respond. TITLE V FINANCIAL PROVISIONS CHAPTER 1 General provisions Article 57 Resources 1. The Board shall be responsible for devoting the necessary financial and human resources to the performance of the tasks conferred on it by this Regulation. 2. The funding of the Board's budget or its resolution activities under this Regulation may under no circumstances engage the budgetary liability of the Member States. Article 58 Budget 1. The Board shall have an autonomous budget which is not part of the Union budget. Estimates of all of the Board's revenue and expenditure shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in the Board's budget. 2. The Board's budget shall be balanced in terms of revenue and expenditure. 3. The budget shall comprise two parts: Part I for the administration of the Board and Part II for the Fund. Article 59 Part I of the budget on the administration of the Board 1. The revenues of Part I of the budget shall consist of the annual contributions necessary to cover the annual estimated administrative expenditure. 2. The expenditure of Part I of the budget shall include at least staff, remuneration, administrative, infrastructure, professional training and operational expenses. 3. This Article is without prejudice to the right of the national resolution authorities to levy fees in accordance with national law, in respect of their administrative expenditures of the types referred to in paragraphs 1 and 2, including expenditures for cooperating with and assisting the Board. Article 60 Part II of the budget on the Fund 1. The revenues of Part II of the budget shall consist, in particular, of the following: (a) contributions paid by institutions established in the participating Member States in accordance with Article 67(4) and Articles 69, 70 and 71; (b) loans received from other resolution financing arrangements in non-participating Member States in accordance with Article 72(1); (c) loans received from financial institutions or other third parties in accordance with Articles 73 and 74; (d) returns on the investments of the amounts held in the Fund in accordance with Article 75; (e) any part of the expenses incurred for the purposes indicated in Article 76 which are recovered in the resolution proceedings. 2. The expenditure of Part II of the budget shall consist of the following: (a) expenses for the purposes indicated in Article 76; (b) investments in accordance with Article 75; (c) interest paid on loans received from other resolution financing arrangements in non-participating Member States in accordance with Article 72(1); (d) interest paid on loans received from financial institutions or other third parties in accordance with Articles 73 and 74. Article 61 Establishment and implementation of the budget 1. By 15 February each year, the Chair shall draw up a draft budget of the Board, including a statement of estimates of the Board's revenue and expenditure for the following year together with the establishment plan and shall submit it to the Board for adoption. 2. By 31 March each year, the Board in its plenary session shall, where necessary, adjust the draft submitted by the Chair and adopt the final budget of the Board together with the establishment plan. Article 62 Internal audit and control 1. An internal audit function shall be set up within the Board, to be performed in compliance with the relevant international standards. The internal auditor, appointed by the Board, shall be responsible to it for verifying the proper operation of budget implementation systems and budgetary procedures of the Board. 2. The internal auditor shall advise the Board on dealing with risks, by issuing independent opinions on the quality of management and control systems and by issuing recommendations for improving the conditions of implementation of operations and promoting sound financial management. 3. The responsibility for putting in place internal control systems and procedures suitable for performing the tasks of the internal auditor shall lie with the Board. Article 63 Implementation of the budget, presentation of accounts and discharge 1. The Chair shall act as authorising officer and shall implement the Board's budget. 2. By 1 March of the following financial year, the Board's Accounting Officer shall send the provisional accounts, accompanied by the report on budgetary and financial management during the financial year, to the Court of Auditors for observations. By 31 March of the following financial year, the Board's Accounting Officer shall submit the report on budgetary and financial management to the members of the Board, and to the European Parliament, the Council and the Commission. 3. By 31 March each year, the Chair shall transmit to the European Parliament, the Council and the Commission the Board's provisional accounts for the preceding financial year. 4. On receipt of the Court of Auditors' observations on the Board's provisional accounts, the Chair, acting on his or her own responsibility, shall draw up the Board's final accounts and shall send them to the Board in its plenary session, for approval. 5. The Chair shall, following the approval by the Board, by 1 July each year, send the final accounts for the preceding financial year to the European Parliament, the Council, the Commission, and the Court of Auditors. 6. Where observations are received from the Court of Auditors, the Chair shall send a reply by 30 September. 7. By 15 November each year, the final accounts for the preceding financial year shall be published in the Official Journal of the European Union. 8. The Board, in its plenary session, shall give discharge to the Chair in respect of the implementation of the budget. 9. The Chair shall submit at the request of either the European Parliament or the Council, any information referred to in the Board's accounts to the requesting Union institution, subject to the requirements of professional secrecy laid down in this Regulation. Article 64 Financial rules The Board shall, after consulting the Court of Auditors and the Commission, adopt internal financial provisions specifying, in particular, the detailed procedure for establishing and implementing its budget in accordance with Articles 61 and 63. As far as is compatible with the particular nature of the Board, the financial provisions shall be based on the framework financial Regulation adopted for bodies set up under the TFEU in accordance with Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (20). Article 65 Contributions to the administrative expenditures of the Board 1. Entities referred to in Article 2 shall contribute to part I of the budget of the Board in accordance with this Regulation and the delegated acts on contributions adopted pursuant to paragraph 5 of this Article. 2. The amounts of the contributions shall be fixed at such a level as to ensure that the revenue in respect thereof is in principle sufficient for part I of the budget of the Board to be balanced each year. 3. The Board shall determine and raise, in accordance with the delegated acts referred to in paragraph 5 of this Article, the contributions due by each entity referred to in Article 2 in a decision addressed to the entity concerned. The Board shall apply procedural, reporting and other rules ensuring that contributions are paid fully and in a timely manner. 4. The amounts raised in accordance with paragraphs 1, 2, 3 shall be used only for the purposes of this Regulation. 5. The Commission shall be empowered to adopt delegated acts on contributions in accordance with Article 93 in order to: (a) determine the type of contributions and the matters for which contributions are due, the manner in which the amount of the contributions is calculated, and the way in which they are to be paid; (b) specify registration, accounting, reporting and other rules referred to in paragraph 3 necessary to ensure that the contributions are paid fully and in a timely manner; (c) determine the annual contributions necessary to cover the administrative expenditure of the Board before it becomes fully operational. Article 66 Anti-fraud measures 1. For the purposes of combating fraud, corruption and any other unlawful activity under Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (21), within six months from the day the Board becomes operational, it shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by OLAF and shall immediately adopt appropriate provisions applicable to all staff of the Board using the template set out in the Annex to that Interinstitutional Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over the beneficiaries, contractors and subcontractors who have received funds from the Board. 3. OLAF may carry out investigations, including on-the-spot checks and inspections with a view to establishing whether there has been fraud, corruption or other illegal activity affecting the financial interests of the Union in connection with a contract funded by the Board in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 (22) and Regulation (EU, Euratom) No 883/2013. CHAPTER 2 The Single Resolution Fund Section 1 Constitution of the Fund Article 67 General provisions 1. The Single Resolution Fund (\u2018the Fund\u2019) is hereby established. It shall be filled in accordance with the rules on transferring the funds raised at national level towards the Fund as laid down in the Agreement. 2. The Board shall use the Fund only for the purpose of ensuring the efficient application of the resolution tools and exercise of the resolution powers referred to in Part II, Title I and in accordance with the resolution objectives and the principles governing resolution referred to in Articles 14 and 15. Under no circumstances shall the Union budget or the national budgets be held liable for expenses or losses of the Fund. 3. The owner of the Fund shall be the Board. 4. Contributions referred to in Articles 69, 70 and 71 shall be raised from entities referred to in Article 2 by the national resolution authorities and transferred to the Fund in accordance with the Agreement. Article 68 Requirement to establish resolution financing arrangements Participating Member States shall establish financing arrangements in accordance with Article 100 of Directive 2014/59/EU and with this Regulation. Article 69 Target level 1. By the end of an initial period of eight years from 1 January 2016 or, otherwise, from the date on which this paragraph is applicable by virtue of Article 99(6), the available financial means of the Fund shall reach at least 1 % of the amount of covered deposits of all credit institutions authorised in all of the participating Member States. 2. During the initial period referred to in paragraph 1, contributions to the Fund calculated in accordance with Article 70, and raised in accordance with Article 67(4), shall be spread out in time as evenly as possible until the target level is reached, but with due account of the phase of the business cycle and the impact that pro-cyclical contributions may have on the financial position of contributing institutions. 3. The Board shall extend the initial period referred to in paragraph 1 for a maximum of four years in the event that the Fund has made cumulative disbursements in excess of 0,5 % of the total amount of covered deposits referred to in paragraph 1 and where the criteria of the delegated act referred in paragraph 5(b) are met. 4. If, after the initial period referred to in paragraph 1, the available financial means diminish below the target level specified in that paragraph, the regular contributions calculated in accordance with Article 70 shall be raised until the target level is reached. After the target level has been reached for the first time and where the available financial means have subsequently been reduced to less than two-thirds of the target level, those contributions shall be set at a level allowing for reaching the target level within six years. The regular contribution shall take due account of the phase of the business cycle, and the impact pro-cyclical contributions may have when setting annual contributions in the context of this paragraph. 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 93 to specify the following: (a) criteria for the spreading out in time of the contributions to the Fund calculated under paragraph 2; (b) criteria for determining the number of years by which the initial period referred to in paragraph 1 can be extended under paragraph 3; (c) criteria for establishing the annual contributions provided for in paragraph 4. Article 70 Ex-ante contributions 1. The individual contribution of each institution shall be raised at least annually and shall be calculated pro-rata to the amount of its liabilities (excluding own funds) less covered deposits, with respect to the aggregate liabilities (excluding own funds) less covered deposits, of all of the institutions authorised in the territories of all of the participating Member States. 2. Each year, the Board shall, after consulting the ECB or the national competent authority and in close cooperation with the national resolution authorities, calculate the individual contributions to ensure that the contributions due by all of the institutions authorised in the territories of all of the participating Member States shall not exceed 12,5 % of the target level. Each year the calculation of the contributions for individual institutions shall be based on: (a) a flat contribution, that is pro-rata based on the amount of an institution's liabilities excluding own funds and covered deposits, with respect to the total liabilities, excluding own funds and covered deposits, of all of the institutions authorised in the territories of the participating Member States; and (b) a risk-adjusted contribution, that shall be based on the criteria laid down in Article 103(7) of Directive 2014/59/EU, taking into account the principle of proportionality, without creating distortions between banking sector structures of the Member States. The relation between the flat contribution and the risk-adjusted contributions shall take into account a balanced distribution of contributions across different types of banks. In any case, the aggregate amount of individual contributions by all of the institutions authorised in the territories of all of the participating Member States, calculated under points (a) and (b), shall not exceed annually the 12,5 % of the target level. 3. The available financial means to be taken into account in order to reach the target level specified in Article 69 may include irrevocable payment commitments which are fully backed by collateral of low-risk assets unencumbered by any third-party rights, at the free disposal of and earmarked for the exclusive use by the Board for the purposes specified in Article 76(1). The share of those irrevocable payment commitments shall not exceed 30 % of the total amount of contributions raised in accordance with this Article. 4. The duly received contributions of each entity referred to in Article 2 shall not be reimbursed to those entities. 5. Where participating Member States have already established national resolution financing arrangements, they may provide that those arrangements use their available financial means, collected from institutions between 17 June 2010 and the date of entry into force of Directive 2014/59/EU, to compensate institutions for the ex-ante contributions which those institutions may be required to pay into the Fund. Such restitution shall be without prejudice to the obligations of Member States laid down in Directive 2014/49/EU. 6. The delegated acts specifying the notion of adjusting contributions in proportion to the risk profile of institutions, adopted by the Commission under Article 103(7) of Directive 2014/59/EU, shall be applied. 7. The Council, acting on a proposal from the Commission, shall, within the framework of the delegated acts referred to in paragraph 6, adopt implementing acts to determine the conditions of implementation of paragraphs 1, 2, and 3, and in particular in relation to: (a) the application of the methodology for the calculation of individual contributions; (b) the practical modalities for allocating to institutions the risk factors specified in the delegated act. Article 71 Extraordinary ex-post contributions 1. Where the available financial means are not sufficient to cover the losses, costs or other expenses incurred by the use of the Fund in resolution actions, extraordinary ex-post contributions from the institutions authorised in the territories of participating Member States shall be raised, in order to cover the additional amounts. Those extraordinary ex-post contributions shall be calculated and allocated between institutions in accordance with the rules laid down in Articles 69 and 70. The total amount of extraordinary ex-post contributions per year shall not exceed three times the annual amount of contributions determined in accordance with Article 70. 2. The Board shall, on its own initiative after consulting the national resolution authority or upon proposal by a national resolution authority, defer, in whole or in part, in accordance with the delegated acts referred to in paragraph 3, an institution's payment of extraordinary ex-post contributions in accordance with paragraph 1 if it is necessary to protect its financial position. Such a deferral shall not be granted for a period of longer than six months but may be renewed on request of the institution. The contributions deferred pursuant to this paragraph shall be made later at a point in time when the payment no longer jeopardises the institution's financial position. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 93 to specify the circumstances and conditions under which the payment of ex-post contributions by an entity referred to in Article 2 may be partially or entirely deferred pursuant to paragraph 2 of this Article. Article 72 Voluntary borrowing between resolution financing arrangements 1. The Board shall decide to make a request to voluntarily borrow for the Fund from resolution financing arrangements within non-participating Member States, in the event that: (a) the amounts raised under Article 70 are not sufficient to cover the losses, costs or other expenses incurred by the use of the Fund in relation to resolution actions; (b) the extraordinary ex-post contributions provided for in Article 71 are not immediately accessible; and (c) the alternative funding means provided for in Article 73 are not immediately accessible on reasonable terms. 2. Those resolution financing arrangements shall decide on such a request in accordance with Article 106 of Directive 2014/59/EU. The borrowing conditions shall be subject to Article 106(4), (5) and (6) of Directive 2014/59/EU. 3. The Board may decide to lend to other resolution financing arrangements within non-participating Member States if a request is made in accordance with Article 106 of Directive 2014/59/EU. The lending conditions shall be subject to Article 106(4), (5) and (6) of Directive 2014/59/EU. Article 73 Alternative funding means 1. The Board may contract for the Fund borrowings or other forms of support from those institutions, financial institutions or other third parties, which offer better financial terms at the most appropriate time so as to optimise the cost of funding and preserve its reputation in the event that the amounts raised in accordance with Articles 70 and 71 are not immediately accessible or do not cover the expenses incurred by the use of the Fund in relation to resolution actions. 2. The borrowing or other forms of support referred to in paragraph 1 shall be fully recouped in accordance with Articles 69, 70 and 71 within the maturity period of the loan. 3. Any expenses incurred by the use of the borrowings specified in paragraph 1 shall be borne by Part II of the budget of the Board and not by the Union budget or the participating Member States. Article 74 Access to financial facility The Board shall contract for the Fund financial arrangements, including, where possible, public financial arrangements, regarding the immediate availability of additional financial means to be used in accordance with Article 76, where the amounts raised or available in accordance with Articles 70 and 71 are not sufficient to meet the Funds' obligations. Section 2 Administration of the Fund Article 75 Investments 1. The Board shall administer the Fund in accordance with this Regulation and delegated acts adopted under paragraph 4. 2. The amounts received from an institution under resolution or a bridge institution, the interests and other earnings on investments and any other earnings shall benefit only the Fund. 3. The Board shall have a prudent and safe investment strategy that is provided for in the delegated acts adopted pursuant to paragraph 4 of this Article, and shall invest the amounts held in the Fund in obligations of the Member States or intergovernmental organisations, or in highly liquid assets of high creditworthiness, taking into account the delegated act referred to in Article 460 of Regulation (EU) No 575/2013 as well as other relevant provisions of that Regulation. Investments shall be sufficiently sectorally, geographically and proportionally diversified. The return on those investments shall benefit the Fund. 4. The Commission shall be empowered to adopt delegated acts on the detailed rules for the administration of the Fund and general principles and criteria for its investment strategy, in accordance with the procedure laid down in Article 93. Section 3 Use of the Fund Article 76 Mission of the Fund 1. Within the resolution scheme, when applying the resolution tools to entities referred to in Article 2, the Board may use the Fund only to the extent necessary to ensure the effective application of the resolution tools for the following purposes: (a) to guarantee the assets or the liabilities of the institution under resolution, its subsidiaries, a bridge institution or an asset management vehicle; (b) to make loans to the institution under resolution, its subsidiaries, a bridge institution or an asset management vehicle; (c) to purchase assets of the institution under resolution; (d) to make contributions to a bridge institution and an asset management vehicle; (e) to pay compensation to shareholders or creditors if, following an evaluation pursuant to Article 20(5) they have incurred greater losses that they would have incurred, following a valuation pursuant to Article 20(16), in a winding up under normal insolvency proceedings; (f) to make a contribution to the institution under resolution in lieu of the write-down or conversion of liabilities of certain creditors, when the bail-in tool is applied and the decision is made to exclude certain creditors from the scope of bail-in in accordance with Article 27(5); (g) to take any combination of the actions referred to in points (a) to (f). 2. The Fund may be used to take the actions referred to in paragraph 1 also with respect to the purchaser in the context of the sale of business tool. 3. The Fund shall not be used directly to absorb the losses of an entity referred to in Article 2 or to recapitalise such an entity. In the event that the use of the Fund for the purposes in paragraph 1of this Article indirectly results in part of the losses of an entity referred to in Article 2 being passed on to the Fund, the principles governing the use of the Fund set out in Article 27 shall apply. 4. The Board may not hold the capital contributed to in accordance with point (f) of paragraph 1 for a period exceeding five years. Article 77 Use of the Fund The use of the Fund shall be contingent upon the Agreement whereby the participating Member States agree to transfer to the Fund the contributions that they raise at national level in accordance with this Regulation and with Directive 2014/59/EU and shall comply with the principles laid down in that Agreement. Accordingly, until the Fund reaches the target level referred to in Article 69, but until no later than eight years after the date of application of this Article, the Board shall use the Fund in accordance with principles founded on a division of the Fund into national compartments corresponding to each participating Member State, as well as on a progressive merger of the different funds raised at national level to be allocated to national compartments of the Fund, as laid down in the Agreement. Article 78 Mutualisation of national financing arrangements in the case of group resolution involving institutions in non-participating Member States In the case of a group resolution involving institutions established in one or more participating Member States on the one hand, and institutions established in one or more non-participating Member States on the other hand, the Fund shall contribute to the financing of the group resolution in accordance with the provisions laid down in Article 107(2) to (5) of Directive 2014/59/EU. Article 79 Use of deposit guarantee schemes in the context of resolution 1. Participating Member States shall ensure that when the Board takes resolution action, provided that that action ensures that depositors continue to have access to their deposits, the deposit guarantee scheme to which the institution is affiliated shall be liable for the amounts specified in Article 109(1) and (4) of Directive 2014/59/EU. The relevant deposit guarantee scheme shall subrogate to the rights and obligations of covered depositors in liquidation proceedings for an amount equal to its payment. 2. The determination of the amount by which the deposit guarantee scheme is liable in accordance with paragraph 1 of this Article shall comply with the conditions referred to in Article 20. 3. Before deciding, in accordance with paragraph 2 of this Article, the amount by which the deposit guarantee scheme is liable, the Board shall consult the concerned designated authority within the meaning of Article 2(1)(18) of Directive 2014/49/EU, taking fully into account the urgency of the matter. 4. Where eligible deposits at an institution under resolution are transferred to another entity through the sale of business tool or the bridge institution tool, the depositors have no claim under Directive 2014/49/EU against the deposit guarantee scheme in relation to any part of their deposits at the institution under resolution that are not transferred, provided that the amount of funds transferred is equal to or more than the aggregate coverage level provided for in Article 6 of that Directive. 5. Notwithstanding paragraphs 1 to 4, if the available financial means of a deposit guarantee scheme are used in accordance therewith and are subsequently reduced to less than two-thirds of the target level of the deposit guarantee scheme, the regular contribution to the deposit guarantee scheme shall be set at a level allowing for reaching the target level within six years. The liability of a deposit guarantee scheme shall not be greater than the amount equal to 50 % of its target level pursuant to Article 10(2) of Directive 2014/49/EU. In any circumstances, the deposit guarantee scheme's participation under this Regulation shall not exceed the losses it would have incurred in a winding up under normal insolvency proceedings. TITLE VI OTHER PROVISIONS Article 80 Privileges and Immunities Protocol No 7 on the Privileges and Immunities of the European Union annexed to the TEU and to the TFEU shall apply to the Board and its staff. Article 81 Language arrangements 1. Council Regulation No 1 (23) shall apply to the Board. 2. The Board shall decide on the internal language arrangements for the Board. 3. The Board may decide which of the official languages to use when sending documents to Union institutions or bodies. 4. The Board may agree with each national resolution authority on the language or languages in which the documents to be sent to or by the national resolution authorities shall be drafted. 5. The translation services required for the functioning of the Board shall be provided by the Translation Centre of the bodies of the European Union. Article 82 Staff 1. The Staff Regulations, the Conditions of Employment and the rules adopted jointly by the Union institutions, for the purpose of applying them shall apply to the staff of the Board. By way of derogation from the first subparagraph, the Chair, the Vice-Chair and the four members referred to in Article 43(1)(b) shall, respectively, be on a par with a Vice-President, Judge and Registrar of the Court of Justice regarding emoluments and pensionable age, as defined in Regulation (EC) No 422/67/EEC, 5/67/Euratom of the Council (24). They shall not be subject to a maximum retirement age. For aspects not covered by this Regulation or by Regulation (EC) No 422/67/EEC, 5/67/Euratom, the Staff Regulations and the Conditions of Employment shall apply by analogy. 2. The Board, in agreement with the Commission, shall adopt the necessary implementing measures, in accordance with the arrangements provided for in Article 110 of the Staff Regulations. 3. In respect of its staff, the Board shall exercise the powers conferred on the appointing authority by the Staff Regulations and on the authority entitled to conclude contracts by the Conditions of Employment. Article 83 Staff exchange 1. The Board may make use of seconded national experts or other staff not employed by the Board. 2. The Board in its plenary session shall adopt appropriate decisions laying down rules on the exchange and secondment of staff from and among the national resolution authorities to the Board. 3. The Board may establish internal resolution teams composed of its own staff and staff of the national resolution authorities, as well as observers from non-participating Member States' resolution authorities, where appropriate. 4. Where the Board establishes internal resolution teams as provided for in paragraph 3 of this Article, it shall appoint coordinators of those teams from its own staff. In accordance with Article 51(3), the coordinators may be invited as observers to attend the meetings of the executive session of the Board in which the members appointed by the respective Member States participate in accordance with Article 53(3) and (4). Article 84 Internal committees The Board may establish internal committees to provide it with advice and guidance on the discharge of its functions under this Regulation. Article 85 Appeal Panel 1. The Board shall establish an Appeal Panel for the purposes of deciding on appeals submitted in accordance with paragraph 3. 2. The Appeal Panel shall be composed of five individuals of high repute, from the Member States and with a proven record of relevant knowledge and professional experience, including resolution experience, to a sufficiently high level in the fields of banking or other financial services, excluding current staff of the Board, as well as current staff of resolution authorities or other national or Union institutions, bodies, offices and agencies who are involved in performing the tasks conferred on the Board by this Regulation. The Appeal Panel shall have sufficient resources and expertise to provide expert legal advice on the legality of the Board's exercise of its powers. Members of the Appeal Panel and two alternates shall be appointed by the Board for a term of five years, which may be extended once, following a public call for expressions of interest published in the Official Journal of the European Union. They shall not be bound by any instructions. 3. Any natural or legal person, including resolution authorities, may appeal against a decision of the Board referred to in Article 10(10), Article 11, Article 12(1), Articles 38 to 41, Article 65(3), Article 71 and Article 90(3) which is addressed to that person, or which is of direct and individual concern to that person. The appeal, together with a statement of grounds, shall be filed in writing at the Appeal Panel within six weeks of the date of notification of the decision to the person concerned, or, in the absence of a notification, of the day on which the decision came to the knowledge of the person concerned. 4. The Appeal Panel shall decide upon the appeal within one month after the appeal has been lodged. The Appeal Panel shall decide on the basis of a majority of at least three of its five members. 5. The members of the Appeal Panel shall act independently and in the public interest. For that purpose, they shall make a public declaration of commitments and a public declaration of interests indicating any direct or indirect interest which might be considered to be prejudicial to their independence or the absence of any such interest. 6. An appeal lodged pursuant to paragraph 3 shall not have suspensive effect. However, the Appeal Panel may, if it considers that circumstances so require, suspend the application of the contested decision. 7. If the appeal is admissible, the Appeal Panel shall examine whether it is well founded. It shall invite the parties to the appeal proceedings to file observations on its own notifications or on communications from the other parties to the appeal proceedings, within specified time limits. Parties to the appeal proceedings shall be entitled to make oral representations. 8. The Appeal Panel may confirm the decision taken by the Board, or remit the case to the latter. The Board shall be bound by the decision of Appeal Panel and it shall adopt an amended decision regarding the case concerned. 9. The decisions of the Appeal Panel shall be reasoned and notified to the parties. 10. The Appeal Panel shall adopt and make public its rules of procedure. Article 86 Actions before the Court of Justice 1. Proceedings may be brought before the Court of Justice in accordance with Article 263 TFEU contesting a decision taken by the Appeal Panel or, where there is no right of appeal to the Appeal Panel, by the Board. 2. Member States and the Union institutions, as well as any natural or legal person, may institute proceedings before the Court of Justice against decisions of the Board, in accordance with Article 263 TFEU. 3. In the event that the Board has an obligation to act and fails to take a decision, proceedings for failure to act may be brought before the Court of Justice in accordance with Article 265 TFEU. 4. The Board shall take the necessary measures to comply with the judgment of the Court of Justice. Article 87 Liability of the Board 1. The Board's contractual liability shall be governed by the law applicable to the contract in question. 2. The Court of Justice shall have jurisdiction to give judgement pursuant to any arbitration clause contained in a contract concluded by the Board. 3. In the case of non-contractual liability, the Board shall, in accordance with the general principles common to the laws concerning the liability of public authorities of the Member States, make good any damage caused by it or by its staff in the performance of their duties, in particular their resolution functions, including acts and omissions in support of foreign resolution proceedings. 4. The Board shall compensate a national resolution authority for the damages which it has been ordered to pay by a national court, or which it has, in agreement with the Board, undertaken to pay pursuant to an amicable settlement, which are the consequences of an act or omission committed by that national resolution authority in the course of any resolution under this Regulation of entities and groups referred to in Article 7(2), and of entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met or pursuant to the second subparagraph of Article 7(3). That obligation shall not apply where that act or omission constituted an infringement of this Regulation, of another provision of Union law, of a decision of the Board, of the Council, or of the Commission, committed intentionally or with manifest and serious error of judgement. 5. The Court of Justice shall have jurisdiction in any dispute relating to paragraphs 3 and 4. Proceedings in matters arising from non-contractual liability shall be barred after a period of five years from the occurrence of the event giving rise thereto. 6. The personal liability of its staff towards the Board shall be governed by the provisions laid down in the Staff Regulations or Conditions of Employment applicable to them. Article 88 Professional secrecy and exchange of information 1. Members of the Board, the Vice-Chair, the members of the Board referred to in Article 43(1)(b), the staff of the Board and staff exchanged with or seconded by participating Member States carrying out resolution duties shall be subject to the requirements of professional secrecy pursuant to Article 339 TFEU and the relevant provisions in Union legislation, even after their duties have ceased. They shall in particular be prohibited from disclosing confidential information received during the course of their professional activities or from a competent authority or resolution authority in connection with their functions under this Regulation, to any person or authority, unless it is in the exercise of their functions under this Regulation or in summary or collective form such that entities referred to in Article 2 cannot be identified or with the express and prior consent of the authority or the entity which provided the information. Information subject to the requirements of professional secrecy shall not be disclosed to another public or private entity except where such disclosure is due for the purpose of legal proceedings. Those requirements shall also apply to potential purchasers contacted in order to prepare for the resolution of an entity pursuant to Article 13(3). 2. The Board shall ensure that individuals who provide any service, directly or indirectly, permanently or occasionally, relating to the discharge of its duties, including officials and other persons authorised by the Board or appointed by the national resolution authorities to conduct on-site inspections, are subject to the requirements of professional secrecy equivalent to those referred to in paragraph 1. 3. The requirements of professional secrecy referred to in paragraph 1 shall also apply to observers who attend the Board's meetings and to observers from non-participating Member States who take part in internal resolution teams in accordance with Article 83(3). 4. The Board shall take the necessary measures to ensure the safe handling and processing of confidential information. 5. Before any information is disclosed, the Board shall ensure that it does not contain confidential information, in particular, by assessing the effects that the disclosure could have on the public interest as regards financial, monetary or economic policy, on the commercial interests of natural and legal persons, on the purpose of inspections, on investigations and on audits. The procedure for checking the effects of disclosing information shall include a specific assessment of the effects of any disclosure of the contents and details of resolution plans as referred to in Articles 8 and 9, the result of any assessment carried out under Article 10 or the resolution scheme referred to in Article 18. 6. This Article shall not prevent the Board, the Council, the Commission, the ECB, the national resolution authorities or the national competent authorities, including their employees and experts, from sharing information with each other and with competent ministries, central banks, deposit guarantee schemes, investor compensation schemes, authorities responsible for normal insolvency proceedings, resolution and competent authorities from non-participating Member States, EBA, or, subject to Article 33, third-country authorities that carry out functions equivalent to those of a resolution authority, or, subject to strict confidentiality requirements, with a potential purchaser for the purposes of planning or carrying out a resolution action. Article 89 Data protection This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Directive 95/46/EC of the European Parliament and of the Council (25) or the obligations of the Board, the Council and the Commission relating to their processing of personal data under Regulation (EC) No 45/2001 of the European Parliament and of the Council (26) when fulfilling their responsibilities. Article 90 Access to documents 1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council (27) shall apply to documents held by the Board. 2. The Board shall, within six months of the date of its first meeting, adopt the practical measures for applying Regulation (EC) No 1049/2001. 3. Decisions taken by the Board under Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the European Ombudsman or of proceedings before the Court of Justice, following an appeal to the Appeal Panel, referred to in Article 85 of this Regulation, as appropriate, under the conditions laid down in Articles 228 and 263 TFEU respectively. 4. Persons who are the subject of the Board's decisions shall be entitled to have access to the Board's file, subject to the legitimate interest of other persons in the protection of their business secrets. The right of access to the file shall not extend to confidential information or internal preparatory documents of the Board. Article 91 Security rules on the protection of classified and sensitive non-classified information The Board shall apply the security principles contained in the Commission's security rules for protecting European Union Classified Information (EUCI) and sensitive non-classified information, as set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom (28). Applying the security principles shall include applying provisions for the exchange, processing and storage of such information. Article 92 Court of Auditors 1. The Court of Auditors shall produce a special report for each 12-month period, starting on 1 April each year. 2. Each report shall examine whether: (a) sufficient regard was had to economy, efficiency and effectiveness with which the Fund has been used, in particular the need to minimise the use of the Fund; (b) the assessment of Fund aid was efficient and rigorous. 3. Each report under paragraph 1 shall be produced within six months of the end of the period to which the report relates. 4. Following consideration of the final accounts prepared by the Board in accordance with Article 63, the Court of Auditors shall prepare a report on its findings by 1 December following each financial year. The Court of Auditors shall, in particular, report on any contingent liabilities (whether for the Board, the Council, the Commission or otherwise) arising as a result of the performance by the Board, the Council and the Commission of their tasks under this Regulation. 5. The European Parliament and the Council may request that the Court of Auditors examine any other relevant matters falling within their competence set out in Article 287(4) TFEU. 6. The reports referred to in paragraphs 1 and 4 shall be sent to the Board, the European Parliament, the Council and the Commission and shall be made public without delay. 7. Within two months of the date on which each report under paragraph 1 is made public the Commission shall provide a detailed written response which shall be made public. Within two months of the date on which each report under paragraph 4 is made public the Board, the Council and the Commission shall each provide a detailed written response which shall be made public. 8. The Court of Auditors shall have the power to obtain from the Board, the Council and the Commission any information relevant for performing the tasks conferred on it by this Article. The Board, the Council and the Commission shall provide any relevant information requested within such a timeframe as may be specified by the Court of Auditors. PART IV POWERS OF EXECUTION AND FINAL PROVISIONS Article 93 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 19(8), Article 65(5), Article 69(5), Article 71(3) and Article 75(4) shall be conferred for an indeterminate period of time from the relevant dates referred to in Article 99. 3. The Commission shall ensure consistency between delegated acts adopted pursuant to this Regulation and delegated acts adopted pursuant to Directive 2014/59/EU. 4. The delegation of power referred to in Article 19(8), Article 65(5), Article 69(5), Article 71(3) and Article 75(4) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 19(8), Article 65(5), Article 69(5), Article 71(3) and Article 75(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or the Council. 7. The Commission shall not adopt delegated acts where the scrutiny time of the European Parliament is reduced through recess to less than five months, including any extension. Article 94 Review 1. By 31 December 2018, and every three years thereafter, the Commission shall publish a report on the application of this Regulation, with a special emphasis on monitoring the potential impact on the smooth functioning of the internal market. That report shall evaluate: (a) the functioning of the SRM, its cost efficiency, as well as the impact of its resolution activities on the interests of the Union as a whole and on the coherence and integrity of the internal market for financial services, including its possible impact on the structures of the national banking systems within the Union, in comparison with other banking systems, and regarding the effectiveness of cooperation and information sharing arrangements within the SRM, between the SRM and the SSM, and between the SRM, national resolution authorities, competent authorities and resolution authorities of non-participating Member States, in particular assessing whether: (i) there is a need that the functions allocated by this Regulation to the Board, to the Council and to the Commission, be exercised exclusively by an independent Union institution and, if so, whether any changes of the relevant provisions are necessary including at the level of primary law; (ii) cooperation between the SRM, the SSM, the ESRB, EBA, ESMA and EIOPA, and the other authorities which form part of the ESFS, is appropriate; (iii) the investment portfolio in accordance with Article 75 is made of sound and diversified assets; (iv) the link between sovereign debt and banking risk has been broken; (v) governance arrangements, including the division of tasks within the Board and the composition of the voting arrangements both in the executive and the plenary sessions of the Board and its relations with the Commission and the Council are appropriate; (vi) the reference point for setting the target level for the Fund is adequate and in particular, whether covered deposits or total liabilities is a more appropriate basis and if a minimum absolute amount for the Fund should be established in order to avoid volatility in the flow of financial means to the Fund and to ensure the stability and adequacy of the financing of the Fund over time; (vii) it is necessary to modify the target level established for the Fund and the level of contributions in order to ensure a level playing field within the Union; (b) the effectiveness of independence and accountability arrangements; (c) the interaction between the Board and EBA; (d) the interaction between the Board and the national resolution authorities of non-participating Member States and the effects of the SRM on those Member States, and the interaction between the Board and relevant third-country authorities as defined in Article 2(1)(90) of Directive 2014/59/EU; (e) the necessity of taking steps in order to harmonise insolvency proceedings for failed institutions. 2. The report shall be submitted to the European Parliament and to the Council. The Commission shall make accompanying proposals, as appropriate. 3. When reviewing Directive 2014/59/EU, the Commission is invited also to review this Regulation, as appropriate. Article 95 Amendment to Regulation (EU) No 1093/2010 Regulation (EU) No 1093/2010 is amended as follows: (1) In Article 4, point (2) is replaced by the following: \u2018(2) \u201ccompetent authorities\u201d means: (i) competent authorities as defined in point (40) of Article 4(1) of Regulation (EU) No 575/2013, including the European Central Bank with regard to matters relating to the tasks conferred on it by Regulation (EU) No 1024/2013, in Directive 2007/64/EC, and as referred to in Directive 2009/110/EC; (ii) with regard to Directives 2002/65/EC and 2005/60/EC, the authorities competent for ensuring compliance with the requirements of those Directives by credit and financial institutions; (iii) with regard to deposit guarantee schemes, bodies which administer deposit guarantee schemes pursuant to Directive 2014/49/EU of the European Parliament and of the Council (29), or, where the operation of the deposit guarantee scheme is administered by a private company, the public authority supervising those schemes pursuant to that Directive; and (iv) with regard to Directive 2014/59/EU of the European Parliament and of the Council (30) and to Regulation (EU) No 806/2014 of the European Parliament and of the Council (31), the resolution authorities, defined in Article 3 of Directive 2014/59/EU, the Single Resolution Board, established by Regulation (EU) No 806/2014, and the Council and the Commission when taking actions under Article 18 of Regulation (EU) No 806/2014, except where they exercise discretionary powers or make policy choices. (29) Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee scheme (OJ L 173, 12.6.2014, p. 149).\" (30) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190).\" (31) Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, p. 1).\u2019;\" (2) In Article 25, the following paragraph is inserted: \u20181a. The Authority may organise and conduct peer reviews of the exchange of information and of the joint activities of the Board referred to in Regulation (EU) No 806/2014 and national resolution authorities of Member States non-participating in the Single Resolution Mechanism in the resolution of cross-border groups to strengthen effectiveness and consistency in outcomes. To that end, the Authority shall develop methods to allow for objective assessment and comparison.\u2019; (3) In Article 40(6), the following subparagraph is added: \u2018For the purpose of acting within the scope of Directive 2014/59/EU, the Chair of the Single Resolution Board shall be an observer to the Board of Supervisors.\u2019. Article 96 Replacement of national resolution financing arrangements From the date of application referred to in Article 99(2) and (6) of this Regulation, the Fund shall be considered to be the resolution financing arrangement of the participating Member States under Articles 99 to 109 of Directive 2014/59/EU. Article 97 Headquarters Agreement and operating conditions 1. The necessary arrangements concerning the accommodation to be provided for the Board in the Member State where its seat is located and the facilities to be made available by that Member State, as well as the specific rules applicable in that Member State to the Chair, members of the Board in its plenary session, Board staff and members of their families shall be laid down in a Headquarters Agreement between the Board and that Member State, concluded after obtaining the approval of the Board in its plenary session and no later than 20 August 2016. 2. The Member State where the Board's seat is located shall provide the best possible conditions to ensure the proper functioning of the Board, including multilingual, European-oriented schooling and appropriate transport connections. Article 98 Start of the Board's activities 1. The Board shall become fully operational by 1 January 2015. 2. The Commission shall be responsible for the establishment and initial operation of the Board until the Board has the operational capacity to implement its own budget. For that purpose: (a) until the Chair takes up his or her duties following his or her appointment by the Council in accordance with Article 56, the Commission may designate a Commission official to act as interim Chair and exercise the duties assigned to the Chair; (b) by way of derogation from Article 50(1)(l) and until the adoption of a decision as referred to in Article 50(3), the interim Chair shall exercise the appointing authority powers; (c) the Commission may offer assistance to the Board, in particular by seconding Commission officials to carry out the activities of the agency under the responsibility of the interim Chair or the Chair. 3. The interim Chair may authorise all payments covered by appropriations entered in the Board's budget and may conclude contracts, including staff contracts. Article 99 Entry into force 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. With the exceptions set out in paragraphs 3 to 5, this Regulation shall be applicable from 1 January 2016. 3. By way of derogation from paragraph 2 of this Article, the provisions relating to the powers of the Board to collect information and cooperate with the national resolution authorities for the elaboration of resolution planning, under Articles 8 and 9 and all of the other related provisions shall apply from 1 January 2015. 4. By way of derogation from paragraph 2 of this Article, Articles 1 to 4, 6, 30, 42 to 48, 49, Article 50(1)(a), (b) and (g) to (p), Article 50(3), Article 51, Article 52(1) and (4), Article 53(1) and (2), Articles 56 to 59, 61 to 66, 80 to 84, 87 to 95 and 97 and 98 shall apply from 19 August 2014. 5. By way of derogation from paragraph 2 of this Article, Article 69(5), Article 70(6) and (7) and Article 71(3), which empower the Council to adopt implementing acts and the Commission to adopt delegated acts, shall apply from 1 November 2014. 6. From 1 January 2015, the Board shall submit a monthly report approved in its plenary session to the European Parliament, to the Council and to the Commission on whether the conditions for the transfer of contributions to the Fund have been met. From 1 December 2015, where those reports show that the conditions for the transfer of contributions to the Fund have not been met, the application of the provisions referred to in paragraph 2 shall be postponed by one month each time. The Board shall submit a further report each time at the end of that month. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 July 2014. For the European Parliament The President M. SCHULZ For the Council The President S. GOZI (1) OJ C 109, 11.4.2014, p. 2. (2) OJ C 67, 6.3.2014, p. 58. (3) Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of 14 July 2014. (4) Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63). (5) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190). (6) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12). (7) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (8) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338). (9) Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (OJ L 331, 15.12.2010, p. 1). (10) Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee schemes (OJ L 173, 12.6.2014, p. 149). (11) Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Investment and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48). (12) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (13) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32). (14) Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes (OJ L 84, 26.3.1997, p. 22). (15) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349). (16) Council Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses (OJ L 82, 22.3.2001, p. 16). (17) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1). (18) Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (OJ L 166, 11.6.1998, p. 45). (19) Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities and instituting special measures temporarily applicable to officials of the Commission (OJ L 56, 4.3.1968, p. 1). (20) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (21) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (22) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (23) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). (24) Regulation (EC) No 422/67/EEC, No 5/67/Euratom of the Council of 25 July 1967 determining the emoluments of the President and Members of the Commission, of the President, Judges, Advocates-General and Registrar of the Court of Justice, of the President, Members and Registrar of the General Court and of the President, Members and Registrar of the European Union Civil Service Tribunal (OJ L 187, 8.8.1967, p. 1). (25) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (26) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (27) Regulation (EC) N0 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (28) Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure (OJ L 317, 3.12.2001, p. 1).", "summary": "Failing banks and investment firms: rules and procedures Failing banks and investment firms: rules and procedures SUMMARY OF: Regulation (EU) No 806/2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund Regulation (EU) 2019/877 amending Regulation (EU) No 806/2014 as regards the loss-absorbing and recapitalisation capacity of credit institutions and investment firms WHAT IS THE AIM OF THE REGULATION? Regulation (EU) No 806/2014 sets out the structure of the Single Resolution Board (SRB). It is made up of a chair, a vice-chair, 4 permanent members and the authorities from all participating EU countries. It operates in: executive sessions: the chair, 4 further independent full-time members, 2 permanent observers appointed by the European Commission and by the European Central Bank (ECB) and, in specific cases, representatives of national resolution authorities of participating countries or other observers; andplenary sessions: the full board, as above, and representatives of all national resolution authorities of participating countries. It introduces uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms through a single resolution mechanism and the use of a single resolution fund. While the regulation applies to euro area countries, other EU countries are also allowed to participate. Regulation (EU) 2019/877 amends the original regulation to incorporate in EU legislation international standards on loss-absorption and recapitalisation for banks set by the Financial Stability Board. KEY POINTS The Single Resolution Board When a bank is deemed to be in a crisis situation, the board may put together a resolution scheme that is passed on to the Commission for formal approval. If the Commission has no objections, the scheme should be adopted within 24 hours. In some specific cases, the Commission can request the Council to approve its amendments to the scheme. A resolution scheme of less than \u20ac5 billion from the single resolution fund is decided in executive session board meetings, which only include the national resolution authority from the EU country where the bank in crisis is located. When more than \u20ac5 billion is needed, decisions are taken by the plenary session. The single resolution fund Funded by banks from 2016 onwards, the single resolution fund should amount to 1% of insured deposits in all participating EU countries (for a total of around \u20ac55 billion) in 2024. Along with Regulation (EU) No 806/2014, an intergovernmental agreement was signed between participating EU countries. This allows for: the transfer of banks\u2019 contributions to national compartments of the fund; andthe progressive mutualisation* of those contributions in the fund. Single resolution mechanism Together, the SRB and the single resolution fund make up the single resolution mechanism. This system and the single supervisory mechanism, that gives supervisory powers to the ECB, are the foundations of the EU\u2019s banking union, which applies to euro area countries. Other EU countries may also participate. Banks covered The SRB is responsible for the resolution of all banks that are supervised by the ECB. As in the case of the single supervisory mechanism, the SRB is directly responsible for the largest banks that are directly supervised by the ECB and for other cross-border banks. Other banks remain under the direct responsibility of their national resolution authorities. However, they remain under the indirect responsibility of the SRB, and the SRB may step in if their resolution scheme requires the use of the single resolution fund. Calculation of individual institutions\u2019 contributions Regulation (EU) 2015/81 lays down rules relating to the obligation of the SRB to calculate the contributions for individual institutions and the methodology for their calculation. Loss-absorbing and recapitalisation capacity of credit institutions and investment firms In incorporating international standards on loss absorption and recapitalisation into EU law for global systemically important banks and amending the existing rules for other banks, Regulation (EU) 2019/877 provides for the rules for banks to deal with losses by ensuring that they hold enough capital and other liabilities to minimise as much as possible any taxpayer bail-outs. WHEN DOES THE REGULATION APPLY? Regulation (EU) No 806/2014 has applied since 1 January 2016. However, some rules, such as the start of the board\u2019s activities, have applied since 1 January 2015. Regulation (EU) 2019/877 applies from 28 December 2020. BACKGROUND For more information, see: Single resolution mechanism (European Commission) Single supervisory mechanism (European Commission) Communication from the Commission Temporary Framework for State aid measures to support the economy in the current COVID-19 outbreak (European Commission). KEY TERMS Mutualisation: the process by which the costs of restructuring are shared by the participating banks. MAIN DOCUMENTS Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, pp. 1-90) Regulation (EU) 2019/877 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EU) No 806/2014 as regards the loss-absorbing and recapitalisation capacity of credit institutions and investment firms (OJ L 150, 7.6.2019, pp. 226-252) RELATED DOCUMENTS Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, pp. 63-89) Regulation (EU) No 1022/2013 of the European Parliament and of the Council of 22 October 2013 amending Regulation (EU) No 1093/2010 establishing a European Supervisory Authority (European Banking Authority) as regards the conferral of specific tasks on the European Central Bank pursuant to Council Regulation (EU) No 1024/2013 (OJ L 287, 29.10.2013, pp. 5-14) Council Implementing Regulation (EU) 2015/81 of 19 December 2014 specifying uniform conditions of application of Regulation (EU) No 806/2014 of the European Parliament and of the Council with regard to ex ante contributions to the Single Resolution Fund (OJ L 15, 22.1.2015, pp. 1-7) last update 17.12.2019"}
{"article": "12.6.2014 EN Official Journal of the European Union L 173/65 REGULATION (EU) No 598/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on the establishment of rules and procedures with regard to the introduction of noise-related operating restrictions at Union airports within a Balanced Approach and repealing Directive 2002/30/EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) A key objective of the common transport policy is sustainable development. This requires an integrated approach aimed at ensuring both the effective functioning of Union transport systems and protection of the environment. (2) Sustainable development of air transport requires the introduction of measures aimed at reducing the noise impact from aircraft at Union airports. Those measures should improve the noise environment around Union airports in order to maintain or increase the quality of life of neighbouring citizens and foster compatibility between aviation activities and residential areas, in particular where night flights are concerned. (3) Resolution A33/7 of the International Civil Aviation Organization (ICAO) introduces the concept of a \u2018Balanced Approach\u2019 to noise management (Balanced Approach) and establishes a coherent method to address aircraft noise. The Balanced Approach should remain the foundation of noise regulation for aviation as a global industry. The Balanced Approach recognises the value of, and does not prejudge, relevant legal obligations, existing agreements, current laws and established policies. Incorporating the international rules of the Balanced Approach in this Regulation should substantially lessen the risk of international disputes in the event of third-country carriers being affected by noise-related operating restrictions. (4) Following the removal of the noisiest aircraft pursuant to Directive 2002/30/EC of the European Parliament and of the Council (4) and Directive 2006/93/EC of the European Parliament and of the Council (5), an update of how to use operating restriction measures is required to enable authorities to deal with the current noisiest aircraft so as to improve the noise environment around Union airports within the international framework of the Balanced Approach. (5) The report from the Commission of 15 February 2008 entitled \u2018Noise Operation Restrictions at EU Airports\u2019 pointed to the need to clarify in the text of Directive 2002/30/EC the allocation of responsibilities and the precise rights and obligations of interested parties during the noise assessment process so as to guarantee that cost-effective measures are taken to achieve the noise abatement objectives for each airport. (6) The introduction of operating restrictions by Member States at Union airports on a case-by-case basis, whilst limiting capacity, can contribute to improving the noise climate around airports. However, there is a possibility of distorting competition or hampering the overall efficiency of the Union aviation network through the inefficient use of existing capacity. Since the achievement of the specific noise abatement objective of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of harmonised rules on the process for introducing operating restrictions as part of the noise management process, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. Such a harmonised method does not impose noise quality objectives, which continue to derive from Directive 2002/49/EC of the European Parliament and of the Council (6), other relevant Union rules or legislation within each Member State, and does not prejudge the concrete selection of measures. (7) This Regulation should only apply to Member States in which an airport with more than 50 000 civil aircraft movements per calendar year is located and when the introduction of noise-related operating restrictions is being considered at such an airport. (8) This Regulation should apply to aircraft engaged in civil aviation. It should not apply to aircraft such as military aircraft and aircraft undertaking customs, police and fire-fighting operations. Furthermore, various operations of an exceptional nature, such as flights for urgent humanitarian reasons, search and rescue in emergency situations, medical assistance, and disaster relief, should be exempted from this Regulation. (9) While noise assessments should be carried out on a regular basis in accordance with Directive 2002/49/EC, such assessments should only lead to additional noise abatement measures if the current combination of noise mitigating measures does not achieve the noise abatement objectives, taking into account expected airport development. For airports where a noise problem has been identified, additional noise abatement measures should be identified in accordance with the Balanced Approach methodology. In order to ensure a wide application of the Balanced Approach within the Union, its use is recommended whenever it is considered adequate by the individual Member State concerned, even beyond the scope of this Regulation. Noise-related operating restrictions should be introduced only when other Balanced Approach measures are not sufficient to attain the specific noise abatement objectives. (10) While a cost-benefit analysis provides an indication of the total economic welfare effects by comparing all costs and benefits, a cost-effectiveness assessment focuses on achieving a given objective in the most cost-effective way, requiring a comparison of only the costs. This Regulation should not prevent Member States from using cost-benefit analyses where appropriate. (11) The importance of health aspects needs to be recognised in relation to noise problems, and it is therefore important that those aspects be taken into consideration in a consistent manner at all airports when a decision is taken on noise abatement objectives, taking into account the existence of common Union rules in this area. Therefore, health aspects should be assessed in accordance with Union legislation on the evaluation of noise effects. (12) Noise assessments should be based on objective and measurable criteria common to all Member States and should build on existing information available, such as information arising from the implementation of Directive 2002/49/EC. Member States should ensure that such information is reliable, that it is obtained in a transparent manner and that it is accessible to competent authorities and stakeholders. Competent authorities should put in place the necessary monitoring tools. (13) The competent authority responsible for adopting noise-related operating restrictions should be independent of any organisation involved in the airport\u2019s operation, air transport or air navigation service provision, or representing the interests thereof and of the residents living in the vicinity of the airport. This should not be understood as requiring Member States to modify their administrative structures or decision-making procedures. (14) It is recognised that Member States have decided on noise-related operating restrictions in accordance with national legislation based on nationally acknowledged noise methods, which, as yet, might not be fully consistent with the method described in the authoritative European Civil Aviation Conference Report Doc 29 entitled \u2018Standard Method of Computing Noise Contours around Civil Airports\u2019 (ECAC Doc 29) nor use the internationally recognised aircraft noise performance information. However, the efficiency and effectiveness of a noise-related operating restriction should be assessed in accordance with the methods prescribed in ECAC Doc 29 and the Balanced Approach. Accordingly, Member States should adapt their assessments of operating restrictions in national legislation towards full compliance with ECAC Doc 29. (15) A new and wider definition of operating restrictions as compared to Directive 2002/30/EC should be introduced in order to facilitate the implementation of new technologies and new operational capabilities of aircraft and ground equipment. Its application should not lead to delay in the implementation of operational measures which could immediately alleviate the noise impact without substantially affecting the operational capacity of an airport. Such measures should therefore not be considered to constitute new operating restrictions. (16) The centralisation of information on noise would substantially reduce the administrative burden for both aircraft operators and airport operators. Such information is currently provided and managed at the level of individual airports. Those data need to be placed at the disposal of aircraft operators and airports for operational purposes. It is important to use the databank of the European Aviation Safety Agency (\u2018the Agency\u2019) concerning noise performance certification as a validation tool with the European Organisation for the Safety of Air Navigation (Eurocontrol) data on individual flights. Such data are currently already systematically requested for central flow management purposes, but are not at present available to the Commission or to the Agency, and need to be specified for the purpose of this Regulation and for performance regulation of air traffic management. Good access to validated modelling data, determined in accordance with internationally recognised processes and best practices, should improve the quality of mapping of noise contours of individual airports to support policy decisions. (17) To avoid unwanted consequences for aviation safety, airport capacity and competition, the Commission should notify the relevant competent authority if it finds that the process followed for the introduction of noise-related operating restrictions does not meet the requirements of this Regulation. The relevant competent authority should examine the Commission notification and should inform the Commission of its intentions before introducing the operating restrictions. (18) In order to take account of the Balanced Approach, provision should be made for the possibility of exemptions in special circumstances for operators from developing third countries, without which such operators would suffer undue hardship. Reference to \u2018developing countries\u2019 is to be understood in the light of this specific aviation context and does not include all countries that would otherwise be referred to as such, within the international community. In particular, it is necessary to ensure that any such exemptions are compatible with the principle of non-discrimination. (19) In order to reflect the continuous technological progress in engine and airframe technologies and the methods used to map noise contours, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission with respect to regularly updating the noise standards for aircraft referred to in this Regulation and the reference to the associated certification methods, taking into account, when appropriate, changes in relevant ICAO documents and updating the reference to the method for computing noise contours, taking into account, when appropriate, changes in relevant ICAO documents. In addition, changes to ECAC Doc 29 should also be taken into consideration for technical updates through delegated acts, as appropriate. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of all relevant documents to the European Parliament and to the Council. (20) While this Regulation requires a regular assessment of the noise situation at airports, such an assessment does not necessarily entail the adoption of new noise-related operating restrictions or the review of existing ones. Therefore, this Regulation does not require the review of noise-related operating restrictions already in place at the date of its entry into force, including those resulting from court decisions or local mediation processes. Minor technical amendments to measures without substantive implications for capacity or operations should not be considered as new noise-related operating restrictions. (21) Where the consultation process preceding the adoption of a noise-related operating restriction was launched under Directive 2002/30/EC and is still ongoing at the date of entry into force of this Regulation, it is appropriate to allow the final decision to be taken in accordance with Directive 2002/30/EC in order to preserve the progress already achieved in that process. (22) Considering the need for the consistent application of the noise assessment method within the Union aviation market, this Regulation sets out common rules in the field of noise operating restrictions. (23) Directive 2002/30/EC should therefore be repealed, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter, objectives and scope 1. This Regulation lays down, where a noise problem has been identified, rules on the process to be followed for the introduction of noise-related operating restrictions in a consistent manner on an airport-by-airport basis, so as to help improve the noise climate and to limit or reduce the number of people significantly affected by potentially harmful effects of aircraft noise, in accordance with the Balanced Approach. 2. The objectives of this Regulation are: (a) to facilitate the achievement of specific noise abatement objectives, including health aspects, at the level of individual airports, while respecting relevant Union rules, in particular those laid down in Directive 2002/49/EC, and the legislation within each Member State; (b) to enable the use of operating restrictions in accordance with the Balanced Approach so as to achieve the sustainable development of the airport and air traffic management network capacity from a gate-to-gate perspective. 3. This Regulation shall apply to aircraft engaged in civil aviation. It shall not apply to aircraft engaged in military, customs, police or similar operations. Article 2 Definitions For the purpose of this Regulation, the following definitions shall apply: (1) \u2018aircraft\u2019 means fixed-wing aircraft with a maximum certificated take-off mass of 34 000 kg or more, or with a certificated maximum internal accommodation for the aircraft type in question consisting of 19 passenger seats or more, excluding any seats for crew only; (2) \u2018airport\u2019 means an airport which has more than 50 000 civil aircraft movements per calendar year (a movement being a take-off or landing), on the basis of the average number of movements in the last three calendar years before the noise assessment; (3) \u2018Balanced Approach\u2019 means the process developed by the International Civil Aviation Organization under which the range of available measures, namely the reduction of aircraft noise at source, land-use planning and management, noise abatement operational procedures and operating restrictions, is considered in a consistent way with a view to addressing the noise problem in the most cost-effective way on an airport-by-airport basis; (4) \u2018marginally compliant aircraft\u2019 means aircraft which are certified in accordance with limits laid down in Volume 1, Part II, Chapter 3 of Annex 16 to the Convention on International Civil Aviation signed on 7 December 1944 (the Chicago Convention) by a cumulative margin of less than 8 EPNdB (Effective Perceived Noise in Decibels) during a transitional period ending on 14 June 2020, and by a cumulative margin of less than 10 EPNdB following the end of that transitional period, whereby the cumulative margin is the figure expressed in EPNdB obtained by adding the individual margins (i.e. the differences between the certificated noise level and the maximum permitted noise level) at each of the three reference noise measurement points defined in Volume 1, Part II, Chapter 3 of Annex 16 to the Chicago Convention; (5) \u2018noise-related action\u2019 means any measure that affects the noise climate around airports, for which the principles of the Balanced Approach apply, including other non-operational actions that can affect the number of people exposed to aircraft noise; (6) \u2018operating restriction\u2019 means a noise-related action that limits access to or reduces the operational capacity of an airport, including operating restrictions aimed at the withdrawal from operations of marginally compliant aircraft at specific airports as well as operating restrictions of a partial nature, which for example apply for an identified period of time during the day or only for certain runways at the airport. Article 3 Competent authorities 1. A Member State in which an airport as referred to in point (2) of Article 2 is located shall designate one or more competent authorities responsible for the process to be followed when adopting operating restrictions. 2. The competent authorities shall be independent of any organisation which could be affected by noise-related action. That independence may be achieved through a functional separation. 3. The Member States shall notify the Commission, in a timely manner, of the names and addresses of the designated competent authorities referred to in paragraph 1. The Commission shall publish that information. Article 4 Right of appeal 1. Member States shall ensure the right to appeal against operating restrictions adopted pursuant to this Regulation before an appeal body other than the authority that adopted the contested restriction, in accordance with national legislation and procedures. 2. The Member State in which an airport as referred to in point (2) of Article 2 is located shall notify the Commission, in a timely manner, of the name and address of the designated appeal body referred to in paragraph 1 or, where appropriate, of the arrangements for ensuring that an appeal body is appointed. Article 5 General rules on aircraft noise management 1. Member States shall ensure that the noise situation at an individual airport as referred to in point (2) of Article 2 is assessed in accordance with Directive 2002/49/EC. 2. Member States shall ensure that the Balanced Approach is adopted in respect of aircraft noise management at those airports where a noise problem has been identified. To that end, they shall ensure that: (a) the noise abatement objective for that airport, taking into account, as appropriate, Article 8 of, and Annex V to, Directive 2002/49/EC, is defined; (b) measures available to reduce the noise impact are identified; (c) the likely cost-effectiveness of the noise mitigation measures is thoroughly evaluated; (d) the measures, taking into account public interest in the field of air transport as regards the development prospects of their airports, are selected without detriment to safety; (e) the stakeholders are consulted in a transparent way on the intended actions; (f) the measures are adopted and sufficient notification is provided for; (g) the measures are implemented; and (h) dispute resolution is provided for. 3. Member States shall ensure that, when noise-related action is taken, the following combination of available measures is considered, with a view to determining the most cost-effective measure or combination of measures: (a) the foreseeable effect of a reduction of aircraft noise at source; (b) land-use planning and management; (c) noise abatement operational procedures; (d) not applying operating restrictions as a first resort, but only after consideration of the other measures of the Balanced Approach. The available measures may if necessary include the withdrawal of marginally compliant aircraft. Member States, or airport managing bodies, as appropriate, may offer economic incentives to encourage aircraft operators to use less noisy aircraft during the transitional period referred to in point (4) of Article 2. Those economic incentives shall comply with the applicable rules on State aid. 4. The measures may, within the Balanced Approach, be differentiated according to aircraft type, aircraft noise performance, use of airport and air navigation facilities, flight path and/or the timeframe covered. 5. Without prejudice to paragraph 4, operating restrictions which take the form of the withdrawal of marginally compliant aircraft from airport operations shall not affect civil subsonic aircraft that comply, through either original certification or re-certification, with the noise standard laid down in Volume 1, Part II, Chapter 4 of Annex 16 to the Chicago Convention. 6. Measures or a combination of measures taken in accordance with this Regulation for a given airport shall not be more restrictive than is necessary in order to achieve the environmental noise abatement objectives set for that airport. Operating restrictions shall be non-discriminatory, in particular on grounds of nationality or identity, and shall not be arbitrary. Article 6 Rules on noise assessment 1. The competent authorities shall ensure that the noise situation at airports for which they are responsible is assessed on a regular basis, in accordance with Directive 2002/49/EC and the legislation applicable within each Member State. The competent authorities may call on the support of the Performance Review Body referred to in Article 3 of Commission Regulation (EU) No 691/2010 (7). 2. If the assessment referred to in paragraph 1 indicates that new operating restriction measures may be required to address a noise problem at an airport, the competent authorities shall ensure that: (a) the method, indicators and information in Annex I are applied in such a way as to take due account of the contribution of each type of measure under the Balanced Approach, before operating restrictions are introduced; (b) at the appropriate level, technical cooperation is established between the airport operators, aircraft operators and air navigation service providers to examine measures to mitigate noise. The competent authorities shall also ensure that local residents, or their representatives, and relevant local authorities are consulted, and that technical information on noise mitigation measures is provided to them; (c) the cost-effectiveness of any new operating restriction is assessed, in accordance with Annex II. Minor technical amendments to measures without substantive implications on capacity or operations shall not be considered new operating restrictions; (d) the process of consultation with interested parties, which may take the form of a mediation process, is organised in a timely and substantive manner, ensuring openness and transparency as regards data and computation methodologies. Interested parties shall have at least three months prior to the adoption of the new operating restrictions to submit comments. The interested parties shall include at least: (i) local residents living in the vicinity of the airport and affected by air traffic noise, or their representatives, and the relevant local authorities; (ii) representatives of local businesses based in the vicinity of the airport, whose activities are affected by air traffic and the operation of the airport; (iii) relevant airport operators; (iv) representatives of those aircraft operators which may be affected by noise-related actions; (v) the relevant air navigation service providers; (vi) the Network Manager, as defined in Commission Regulation (EU) No 677/2011 (8); (vii) where applicable, the designated slots coordinator. 3. The competent authorities shall follow up and monitor the implementation of the operating restrictions and take action as appropriate. They shall ensure that relevant information is made available free of charge and that it is readily and promptly accessible to local residents living in the vicinity of the airports and to the relevant local authorities. 4. The relevant information may include: (a) while respecting national law, information on alleged infringements due to changes in flight procedures, in terms of their impact and the reasons why such changes were made; (b) the general criteria applied when distributing and managing traffic in each airport, to the extent that those criteria may have an environmental or noise impact; and (c) data collected by noise measuring systems, if available. Article 7 Noise performance information 1. Decisions on noise-related operating restrictions shall be based on the noise performance of the aircraft as determined by the certification procedure conducted in accordance with Volume 1 of Annex 16 to the Chicago Convention, sixth edition of March 2011. 2. At the request of the Commission, aircraft operators shall communicate the following noise information in respect of the aircraft that they operate at Union airports: (a) the aircraft nationality and registration mark; (b) the noise documentation of the aircraft used, together with the associated maximum take-off weight; (c) any modification of the aircraft which affects its noise performance and is stated on the noise documentation. 3. Upon request of the Agency, holders of an aircraft type certificate or a supplemental type certificate issued in accordance with Regulation (EC) No 216/2008 of the European Parliament and of the Council (9), and legal or natural persons operating aircraft for which no type certificate has been issued under that Regulation, shall provide aircraft noise and performance information for noise modelling purposes. The Agency shall specify the data required and the timeframe for, and the form and manner of, its provision. The Agency shall verify the received aircraft noise and performance information for modelling purposes and shall make the information available to other parties for noise modelling purposes. 4. The data referred to in paragraphs 2 and 3 of this Article shall be limited to what is strictly necessary and shall be provided free of charge, in electronic form and using the format specified, where applicable. 5. The Agency shall verify the aircraft noise and performance data for modelling purposes in relation to its tasks performed in accordance with Article 6(1) of Regulation (EC) No 216/2008. 6. Data shall be stored in a central database and made available to competent authorities, aircraft operators, air navigation service providers and airport operators for operational purposes. Article 8 Rules on the introduction of operating restrictions 1. Before introducing an operating restriction, the competent authorities shall give to the Member States, the Commission and the relevant interested parties six months\u2019 notice, ending at least two months prior to the determination of the slot coordination parameters as defined in point (m) of Article 2 of Council Regulation (EEC) No 95/93 (10) for the airport concerned for the relevant scheduling period. 2. Following the assessment carried out in accordance with Article 6, the notification shall be accompanied by a written report in accordance with the requirements specified in Article 5 explaining the reasons for introducing the operating restriction, the noise abatement objective established for the airport, the measures that were considered to meet that objective, and the evaluation of the likely cost-effectiveness of the various measures considered, including, where relevant, their cross-border impact. 3. At the request of a Member State or on its own initiative, the Commission may, within a period of three months after the day on which it receives notice under paragraph 1, review the process for the introduction of an operating restriction. Where the Commission finds that the introduction of a noise-related operating restriction does not follow the process set out in this Regulation, it may notify the relevant competent authority accordingly. The relevant competent authority shall examine the Commission notification and inform the Commission of its intentions before introducing the operating restriction. 4. Where the operating restriction concerns the withdrawal of marginally compliant aircraft from an airport, no additional services above the number of movements with marginally compliant aircraft in the corresponding period of the previous year shall be allowed at that airport six months after the notification referred to in paragraph 1. The Member States shall ensure that the competent authorities decide on the annual rate for reducing the number of movements of marginally compliant aircraft of affected operators at that airport, taking due account of the age of the aircraft and the composition of the total fleet. Without prejudice to Article 5(4), that rate shall not be more than 25 % of the number of movements of marginally compliant aircraft for each operator serving that airport. Article 9 Developing countries 1. In order to avoid undue economic hardship, the competent authorities may exempt marginally compliant aircraft registered in developing countries from noise operating restrictions, while fully respecting the principle of non-discrimination, provided that such aircraft: (a) are granted a noise certification to the standards specified in Chapter 3, Volume 1 of Annex 16 to the Chicago Convention; (b) were operated in the Union during the five-year period preceding the entry into force of this Regulation; (c) were on the register of the developing country concerned in that five-year period; and (d) continue to be operated by a natural or legal person established in that country. 2. Where a Member State grants an exemption provided for in paragraph 1, it shall forthwith inform the competent authorities of the other Member States and the Commission thereof. Article 10 Exemption for aircraft operations of an exceptional nature The competent authorities may, on a case-by-case basis, authorise individual operations at airports for which they are responsible in respect of marginally compliant aircraft which could not otherwise take place on the basis of this Regulation. The exemption shall be limited to: (a) operations which are of such an exceptional nature that it would be unreasonable to withhold a temporary exemption, including humanitarian aid flights; or (b) non-revenue flights for the purpose of alterations, repair or maintenance. Article 11 Delegated acts The Commission shall be empowered to adopt delegated acts in accordance with Article 12 concerning: (a) technical updates to the noise certification standards provided for in Article 5(5) and point (a) of Article 9(1), and to the certification procedure provided for in Article 7(1); (b) technical updates to the methodology and indicators set out in Annex I. The purpose of those updates shall be to take into account changes to relevant international rules, as appropriate. Article 12 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 11 shall be conferred on the Commission for a period of five years from 13 June 2016. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 11 may be revoked by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 11 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 13 Information and revision Member States shall upon request submit information on the application of this Regulation to the Commission. No later than 14 June 2021, the Commission shall report to the European Parliament and to the Council on the application of this Regulation. That report shall be accompanied, where necessary, by proposals for revision of this Regulation. Article 14 Existing operating restrictions Noise-related operating restrictions which were already introduced before 13 June 2016 shall remain in force until the competent authorities decide to revise them in accordance with this Regulation. Article 15 Repeal Directive 2002/30/EC is repealed with effect from 13 June 2016. Article 16 Transitional provisions Notwithstanding Article 15 of this Regulation, noise-related operating restrictions adopted after 13 June 2016 may be adopted in accordance with Directive 2002/30/EC where the consultation process prior to their adoption was ongoing at that date and provided that those restrictions are adopted at the latest one year after that date. Article 17 Entry into force This Regulation shall enter into force on 13 June 2016. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 April 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 181, 21.6.2012, p. 173. (2) OJ C 277, 13.9.2012, p. 110. (3) Position of the European Parliament of 12 December 2012 (not yet published in the Official Journal) and position of the Council at first reading of 24 March 2014 [(not yet published in the Official Journal). Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal). (4) Directive 2002/30/EC of the European Parliament and of the Council of 26 March 2002 on the establishment of rules and procedures with regard to the introduction of noise-related operating restrictions at Community airports (OJ L 85, 28.3.2002, p. 40). (5) Directive 2006/93/EC of the European Parliament and of the Council of 12 December 2006 on the regulation of the operation of aeroplanes covered by Part II, Chapter 3, Volume 1 of Annex 16 to the Convention on International Civil Aviation, second edition (1988) (OJ L 374, 27.12.2006, p. 1). (6) Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (OJ L 189, 18.7.2002, p. 12). (7) Commission Regulation (EU) No 691/2010 of 29 July 2010 laying down a performance scheme for air navigation services and network functions and amending Regulation (EC) No 2096/2005 laying down common requirements for the provision of air navigation services (OJ L 201, 3.8.2010, p. 1). (8) Commission Regulation (EU) No 677/2011 of 7 July 2011 laying down detailed rules for the implementation of air traffic management (ATM) network functions and amending Regulation (EU) No 691/2010 (OJ L 185, 15.7.2011, p. 1). (9) Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1). (10) Council Regulation (EEC) No 95/93 of 18 January 1993 on common rules for the allocation of slots at Community airports (OJ L 14, 22.1.1993, p. 1). ANNEX I ASSESSMENT OF THE NOISE SITUATION AT AN AIRPORT Methodology: Competent authorities will ensure the use of noise assessment methods which have been developed in accordance with the European Civil Aviation Conference Report Doc 29 entitled \u2018Standard Method of Computing Noise Contours around Civil Airports\u2019, 3rd Edition. Indicators: 1. Air traffic noise impact will be described, at least, in terms of noise indicators Lden and Lnight which are defined and calculated in accordance with Annex I to Directive 2002/49/EC. 2. Additional noise indicators which have an objective basis may be used. Noise management information: 1. Current inventory 1.1. A description of the airport, including information about its size, location, surroundings, air traffic volume and mix. 1.2. A description of any environmental objectives for the airport and the national context. This will include a description of the aircraft noise abatement objectives for the airport. 1.3. Details of noise contours for the relevant previous years \u2014 including an assessment of the number of people affected by aircraft noise, carried out in accordance with Annex II to Directive 2002/49/EC. 1.4. A description of the existing and planned measures to manage aircraft noise already implemented in the framework of the Balanced Approach and their impact on and contribution to the noise situation, by reference to: 1.4.1. For reduction at source: (a) information on the current aircraft fleet and any expected technology improvements; (b) specific fleet renewal plans. 1.4.2. For land-use planning and management: (a) planning instruments in place, such as comprehensive planning or noise zoning; (b) mitigating measures in place, such as building codes, noise insulation programmes or measures to reduce areas of sensitive land use; (c) consultation process in respect of the land-use measures; (d) monitoring of encroachment. 1.4.3. For noise abatement operational measures, to the extent that those measures do not restrict the capacity of an airport: (a) use of preferential runways; (b) use of noise-preferential routes; (c) use of noise abatement take-off and approach procedures; (d) indication of the extent to which those measures are regulated under environment indicators, as mentioned in Annex I to Regulation (EU) No 691/2010. 1.4.4. For operating restrictions: (a) use of global restrictions, such as a cap on movements or noise quotas; (b) use of aircraft-specific restrictions, such as the withdrawal of marginally compliant aircraft; (c) use of partial restrictions, drawing a distinction between daytime measures and night-time measures. 1.4.5. The financial instruments in place, such as noise-related airport charges. 2. Forecast without new measures 2.1. Descriptions of airport developments, if any, already approved and in the pipeline, for example, increased capacity, runway and/or terminal expansion, approach and take-off forecasts, projected future traffic mix and estimated growth and a detailed study of the noise impact on the surrounding area caused by expanding the capacity, runways and terminals and by modifying flight paths and approach and take-off routes. 2.2. In the case of airport capacity extension, the benefits of making that additional capacity available within the wider aviation network and the region. 2.3. A description of the effect on noise climate without further measures, and of those measures already planned to ameliorate the noise impact over the same period. 2.4. Forecast noise contours \u2014 including an assessment of the number of people likely to be affected by aircraft noise \u2014 distinguishing between established residential areas, newly constructed or planned residential areas and planned future residential areas that have already been granted authorisation by the competent authorities. 2.5. Evaluation of the consequences and possible costs of not taking action to reduce the impact of increased noise, if it is expected to occur. 3. Assessment of additional measures 3.1. Outline of the additional measures available and an indication of the main reasons for their selection. Description of those measures chosen for further analysis and information on the outcome of the cost-efficiency analysis, in particular the cost of introducing those measures; the number of people expected to benefit and the timeframe; and a ranking of the overall effectiveness of particular measures. 3.2. An overview of the possible environmental and competitive effects of the proposed measures on other airports, operators and other interested parties. 3.3. Reasons for selection of the preferred option. 3.4. A non-technical summary. ANNEX II Assessment of the cost-effectiveness of noise-related operating restrictions The cost-effectiveness of envisaged noise-related operating restrictions will be assessed taking due account of the following elements, to the extent possible, in quantifiable terms: (1) the anticipated noise benefit of the envisaged measures, now and in the future; (2) the safety of aviation operations, including third-party risks; (3) the capacity of the airport; (4) any effects on the European aviation network. In addition, competent authorities may take due account of the following factors: (1) the health and safety of local residents living in the vicinity of the airport; (2) environmental sustainability, including interdependencies between noise and emissions; (3) any direct, indirect or catalytic employment and economic effects. Statement by the Commission on the revision of Directive 2002/49/EC The Commission is discussing with the Member States Annex II to Directive 2002/49/EC (noise calculation methods) with a view to adopting it in the coming months. Based on work the WHO is currently undertaking regarding the methodology to assess health implications of the noise impact, the Commission intends to revise Annex III to Directive 2002/49/ EC (estimation of health impact, dose response curves).", "summary": "EU airport noise EU airport noise With increasing air traffic in prospect, the European Union has agreed new rules on how authorities take decisions setting noise-related operating restrictions at EU airports to limit nuisance from aircraft noise. ACT Regulation (EU) No 598/2014 of the European Parliament and of the Council of 16 April 2014 on the establishment of rules and procedures with regard to the introduction of noise-related operating restrictions at Union airports within a balanced approach and repealing Directive 2002/30/EC. SUMMARY Regulation (EU) No 598/2014 aims to improve the noise environment around EU airports in order to ensure greater compatibility between aviation activities and residential areas, in particular in the case of night flights. The rules are based on the principles of the Balanced approach to noise management agreed by the International Civil Aviation Organisation (ICAO), the United Nations' body dealing with international civil aviation. An operating restriction can take various forms, like setting a noise or a movement limit, introducing a non-addition rule (no additional movements or operations in general, or from a specific type of aircraft) or adopting a curfew for a period of night. Scope The rules apply only to larger airports with more than 50 000 civil aircraft movements per year. They cover civilian aircraft but exclude military, customs and police movements. The setting of specific noise thresholds, however, remains the preserve of national and local authorities. Competent authorities EU countries each appoint competent authorities which take charge of the procedures to be followed for the adoption of operating restrictions. These must be independent of any party that might have a conflict of interest. Right of review Before introducing operating restrictions, competent authorities have to give 6 months' notice to the other Member States, the European Commission and interested parties. The Commission may, within 3 months of receiving the notice, examine the case. If it considers the procedures do not respect the rules, it notifies the competent authority which must, in turn, inform it of the action it intends to take. Health aspects EU legislation regarding the impacts of noise on human health (Directive 2002/49/EC) must be taken into account when any decision is taken on noise reduction objectives. Noise performance information Decisions on operating restrictions must be taken based on individual aircraft noise performance data provided by the operators. This information will be centralised in a database and made available to competent authorities, airlines, air navigation service providers, airports and airport users. Assessment of noise and information for residents Competent authorities must ensure the regular monitoring of noise levels at airports for which they are responsible. If from their evaluation it emerges that operation restrictions could be a cost-effective measure to mitigate noise, a consultation process needs to be organised rapidly and interested parties have 3 months to submit their views before the adoption of restrictions. Authorities must also ensure that information on operating restrictions is promptly and freely available to local residents and local authorities. Phasing-out of noisy aircraft Noise mitigation measures may include the withdrawal of, or extra restrictions upon, the noisier aircraft among those permitted by ICAO rules. Authorities will decide on the annual rate for reducing the number of movements by such aircraft for each operator at a given airport, up to a maximum of 25 %. Regulation (EU) No 598/2014 repeals Directive 2002/30/EC with effect from 13 June 2016. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 598/2014 13.6.2016 - OJ L 173 of 12.6.2014 RELATED ACTS Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (Official Journal L 189 of 18 July 2002). Last updated: 01.08.2014"}
{"article": "5.6.2015 EN Official Journal of the European Union L 141/19 REGULATION (EU) 2015/848 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 May 2015 on insolvency proceedings (recast) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 81 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) On 12 December 2012, the Commission adopted a report on the application of Council Regulation (EC) No 1346/2000 (3). The report concluded that the Regulation is functioning well in general but that it would be desirable to improve the application of certain of its provisions in order to enhance the effective administration of cross-border insolvency proceedings. Since that Regulation has been amended several times and further amendments are to be made, it should be recast in the interest of clarity. (2) The Union has set the objective of establishing an area of freedom, security and justice. (3) The proper functioning of the internal market requires that cross-border insolvency proceedings should operate efficiently and effectively. This Regulation needs to be adopted in order to achieve that objective, which falls within the scope of judicial cooperation in civil matters within the meaning of Article 81 of the Treaty. (4) The activities of undertakings have more and more cross-border effects and are therefore increasingly being regulated by Union law. The insolvency of such undertakings also affects the proper functioning of the internal market, and there is a need for a Union act requiring coordination of the measures to be taken regarding an insolvent debtor's assets. (5) It is necessary for the proper functioning of the internal market to avoid incentives for parties to transfer assets or judicial proceedings from one Member State to another, seeking to obtain a more favourable legal position to the detriment of the general body of creditors (forum shopping). (6) This Regulation should include provisions governing jurisdiction for opening insolvency proceedings and actions which are directly derived from insolvency proceedings and are closely linked with them. This Regulation should also contain provisions regarding the recognition and enforcement of judgments issued in such proceedings, and provisions regarding the law applicable to insolvency proceedings. In addition, this Regulation should lay down rules on the coordination of insolvency proceedings which relate to the same debtor or to several members of the same group of companies. (7) Bankruptcy, proceedings relating to the winding-up of insolvent companies or other legal persons, judicial arrangements, compositions and analogous proceedings and actions related to such proceedings are excluded from the scope of Regulation (EU) No 1215/2012 of the European Parliament and of the Council (4). Those proceedings should be covered by this Regulation. The interpretation of this Regulation should as much as possible avoid regulatory loopholes between the two instruments. However, the mere fact that a national procedure is not listed in Annex A to this Regulation should not imply that it is covered by Regulation (EU) No 1215/2012. (8) In order to achieve the aim of improving the efficiency and effectiveness of insolvency proceedings having cross-border effects, it is necessary, and appropriate, that the provisions on jurisdiction, recognition and applicable law in this area should be contained in a Union measure which is binding and directly applicable in Member States. (9) This Regulation should apply to insolvency proceedings which meet the conditions set out in it, irrespective of whether the debtor is a natural person or a legal person, a trader or an individual. Those insolvency proceedings are listed exhaustively in Annex A. In respect of the national procedures contained in Annex A, this Regulation should apply without any further examination by the courts of another Member State as to whether the conditions set out in this Regulation are met. National insolvency procedures not listed in Annex A should not be covered by this Regulation. (10) The scope of this Regulation should extend to proceedings which promote the rescue of economically viable but distressed businesses and which give a second chance to entrepreneurs. It should, in particular, extend to proceedings which provide for restructuring of a debtor at a stage where there is only a likelihood of insolvency, and to proceedings which leave the debtor fully or partially in control of its assets and affairs. It should also extend to proceedings providing for a debt discharge or a debt adjustment in relation to consumers and self-employed persons, for example by reducing the amount to be paid by the debtor or by extending the payment period granted to the debtor. Since such proceedings do not necessarily entail the appointment of an insolvency practitioner, they should be covered by this Regulation if they take place under the control or supervision of a court. In this context, the term \u2018control\u2019 should include situations where the court only intervenes on appeal by a creditor or other interested parties. (11) This Regulation should also apply to procedures which grant a temporary stay on enforcement actions brought by individual creditors where such actions could adversely affect negotiations and hamper the prospects of a restructuring of the debtor's business. Such procedures should not be detrimental to the general body of creditors and, if no agreement on a restructuring plan can be reached, should be preliminary to other procedures covered by this Regulation. (12) This Regulation should apply to proceedings the opening of which is subject to publicity in order to allow creditors to become aware of the proceedings and to lodge their claims, thereby ensuring the collective nature of the proceedings, and in order to give creditors the opportunity to challenge the jurisdiction of the court which has opened the proceedings. (13) Accordingly, insolvency proceedings which are confidential should be excluded from the scope of this Regulation. While such proceedings may play an important role in some Member States, their confidential nature makes it impossible for a creditor or a court located in another Member State to know that such proceedings have been opened, thereby making it difficult to provide for the recognition of their effects throughout the Union. (14) The collective proceedings which are covered by this Regulation should include all or a significant part of the creditors to whom a debtor owes all or a substantial proportion of the debtor's outstanding debts provided that the claims of those creditors who are not involved in such proceedings remain unaffected. Proceedings which involve only the financial creditors of a debtor should also be covered. Proceedings which do not include all the creditors of a debtor should be proceedings aimed at rescuing the debtor. Proceedings that lead to a definitive cessation of the debtor's activities or the liquidation of the debtor's assets should include all the debtor's creditors. Moreover, the fact that some insolvency proceedings for natural persons exclude specific categories of claims, such as maintenance claims, from the possibility of a debt-discharge should not mean that such proceedings are not collective. (15) This Regulation should also apply to proceedings that, under the law of some Member States, are opened and conducted for a certain period of time on an interim or provisional basis before a court issues an order confirming the continuation of the proceedings on a non-interim basis. Although labelled as \u2018interim\u2019, such proceedings should meet all other requirements of this Regulation. (16) This Regulation should apply to proceedings which are based on laws relating to insolvency. However, proceedings that are based on general company law not designed exclusively for insolvency situations should not be considered to be based on laws relating to insolvency. Similarly, the purpose of adjustment of debt should not include specific proceedings in which debts of a natural person of very low income and very low asset value are written off, provided that this type of proceedings never makes provision for payment to creditors. (17) This Regulation's scope should extend to proceedings which are triggered by situations in which the debtor faces non-financial difficulties, provided that such difficulties give rise to a real and serious threat to the debtor's actual or future ability to pay its debts as they fall due. The time frame relevant for the determination of such threat may extend to a period of several months or even longer in order to account for cases in which the debtor is faced with non-financial difficulties threatening the status of its business as a going concern and, in the medium term, its liquidity. This may be the case, for example, where the debtor has lost a contract which is of key importance to it. (18) This Regulation should be without prejudice to the rules on the recovery of State aid from insolvent companies as interpreted by the case-law of the Court of Justice of the European Union. (19) Insolvency proceedings concerning insurance undertakings, credit institutions, investment firms and other firms, institutions or undertakings covered by Directive 2001/24/EC of the European Parliament and of the Council (5) and collective investment undertakings should be excluded from the scope of this Regulation, as they are all subject to special arrangements and the national supervisory authorities have wide-ranging powers of intervention. (20) Insolvency proceedings do not necessarily involve the intervention of a judicial authority. Therefore, the term \u2018court\u2019 in this Regulation should, in certain provisions, be given a broad meaning and include a person or body empowered by national law to open insolvency proceedings. In order for this Regulation to apply, proceedings (comprising acts and formalities set down in law) should not only have to comply with the provisions of this Regulation, but they should also be officially recognised and legally effective in the Member State in which the insolvency proceedings are opened. (21) Insolvency practitioners are defined in this Regulation and listed in Annex B. Insolvency practitioners who are appointed without the involvement of a judicial body should, under national law, be appropriately regulated and authorised to act in insolvency proceedings. The national regulatory framework should provide for proper arrangements to deal with potential conflicts of interest. (22) This Regulation acknowledges the fact that as a result of widely differing substantive laws it is not practical to introduce insolvency proceedings with universal scope throughout the Union. The application without exception of the law of the State of the opening of proceedings would, against this background, frequently lead to difficulties. This applies, for example, to the widely differing national laws on security interests to be found in the Member States. Furthermore, the preferential rights enjoyed by some creditors in insolvency proceedings are, in some cases, completely different. At the next review of this Regulation, it will be necessary to identify further measures in order to improve the preferential rights of employees at European level. This Regulation should take account of such differing national laws in two different ways. On the one hand, provision should be made for special rules on the applicable law in the case of particularly significant rights and legal relationships (e.g. rights in rem and contracts of employment). On the other hand, national proceedings covering only assets situated in the State of the opening of proceedings should also be allowed alongside main insolvency proceedings with universal scope. (23) This Regulation enables the main insolvency proceedings to be opened in the Member State where the debtor has the centre of its main interests. Those proceedings have universal scope and are aimed at encompassing all the debtor's assets. To protect the diversity of interests, this Regulation permits secondary insolvency proceedings to be opened to run in parallel with the main insolvency proceedings. Secondary insolvency proceedings may be opened in the Member State where the debtor has an establishment. The effects of secondary insolvency proceedings are limited to the assets located in that State. Mandatory rules of coordination with the main insolvency proceedings satisfy the need for unity in the Union. (24) Where main insolvency proceedings concerning a legal person or company have been opened in a Member State other than that of its registered office, it should be possible to open secondary insolvency proceedings in the Member State of the registered office, provided that the debtor is carrying out an economic activity with human means and assets in that State, in accordance with the case-law of the Court of Justice of the European Union. (25) This Regulation applies only to proceedings in respect of a debtor whose centre of main interests is located in the Union. (26) The rules of jurisdiction set out in this Regulation establish only international jurisdiction, that is to say, they designate the Member State the courts of which may open insolvency proceedings. Territorial jurisdiction within that Member State should be established by the national law of the Member State concerned. (27) Before opening insolvency proceedings, the competent court should examine of its own motion whether the centre of the debtor's main interests or the debtor's establishment is actually located within its jurisdiction. (28) When determining whether the centre of the debtor's main interests is ascertainable by third parties, special consideration should be given to the creditors and to their perception as to where a debtor conducts the administration of its interests. This may require, in the event of a shift of centre of main interests, informing creditors of the new location from which the debtor is carrying out its activities in due course, for example by drawing attention to the change of address in commercial correspondence, or by making the new location public through other appropriate means. (29) This Regulation should contain a number of safeguards aimed at preventing fraudulent or abusive forum shopping. (30) Accordingly, the presumptions that the registered office, the principal place of business and the habitual residence are the centre of main interests should be rebuttable, and the relevant court of a Member State should carefully assess whether the centre of the debtor's main interests is genuinely located in that Member State. In the case of a company, it should be possible to rebut this presumption where the company's central administration is located in a Member State other than that of its registered office, and where a comprehensive assessment of all the relevant factors establishes, in a manner that is ascertainable by third parties, that the company's actual centre of management and supervision and of the management of its interests is located in that other Member State. In the case of an individual not exercising an independent business or professional activity, it should be possible to rebut this presumption, for example where the major part of the debtor's assets is located outside the Member State of the debtor's habitual residence, or where it can be established that the principal reason for moving was to file for insolvency proceedings in the new jurisdiction and where such filing would materially impair the interests of creditors whose dealings with the debtor took place prior to the relocation. (31) With the same objective of preventing fraudulent or abusive forum shopping, the presumption that the centre of main interests is at the place of the registered office, at the individual's principal place of business or at the individual's habitual residence should not apply where, respectively, in the case of a company, legal person or individual exercising an independent business or professional activity, the debtor has relocated its registered office or principal place of business to another Member State within the 3-month period prior to the request for opening insolvency proceedings, or, in the case of an individual not exercising an independent business or professional activity, the debtor has relocated his habitual residence to another Member State within the 6-month period prior to the request for opening insolvency proceedings. (32) In all cases, where the circumstances of the matter give rise to doubts about the court's jurisdiction, the court should require the debtor to submit additional evidence to support its assertions and, where the law applicable to the insolvency proceedings so allows, give the debtor's creditors the opportunity to present their views on the question of jurisdiction. (33) In the event that the court seised of the request to open insolvency proceedings finds that the centre of main interests is not located on its territory, it should not open main insolvency proceedings. (34) In addition, any creditor of the debtor should have an effective remedy against the decision to open insolvency proceedings. The consequences of any challenge to the decision to open insolvency proceedings should be governed by national law. (35) The courts of the Member State within the territory of which insolvency proceedings have been opened should also have jurisdiction for actions which derive directly from the insolvency proceedings and are closely linked with them. Such actions should include avoidance actions against defendants in other Member States and actions concerning obligations that arise in the course of the insolvency proceedings, such as advance payment for costs of the proceedings. In contrast, actions for the performance of the obligations under a contract concluded by the debtor prior to the opening of proceedings do not derive directly from the proceedings. Where such an action is related to another action based on general civil and commercial law, the insolvency practitioner should be able to bring both actions in the courts of the defendant's domicile if he considers it more efficient to bring the action in that forum. This could, for example, be the case where the insolvency practitioner wishes to combine an action for director's liability on the basis of insolvency law with an action based on company law or general tort law. (36) The court having jurisdiction to open the main insolvency proceedings should be able to order provisional and protective measures as from the time of the request to open proceedings. Preservation measures both prior to and after the commencement of the insolvency proceedings are important to guarantee the effectiveness of the insolvency proceedings. In that connection, this Regulation should provide for various possibilities. On the one hand, the court competent for the main insolvency proceedings should also be able to order provisional and protective measures covering assets situated in the territory of other Member States. On the other hand, an insolvency practitioner temporarily appointed prior to the opening of the main insolvency proceedings should be able, in the Member States in which an establishment belonging to the debtor is to be found, to apply for the preservation measures which are possible under the law of those Member States. (37) Prior to the opening of the main insolvency proceedings, the right to request the opening of insolvency proceedings in the Member State where the debtor has an establishment should be limited to local creditors and public authorities, or to cases in which main insolvency proceedings cannot be opened under the law of the Member State where the debtor has the centre of its main interests. The reason for this restriction is that cases in which territorial insolvency proceedings are requested before the main insolvency proceedings are intended to be limited to what is absolutely necessary. (38) Following the opening of the main insolvency proceedings, this Regulation does not restrict the right to request the opening of insolvency proceedings in a Member State where the debtor has an establishment. The insolvency practitioner in the main insolvency proceedings or any other person empowered under the national law of that Member State may request the opening of secondary insolvency proceedings. (39) This Regulation should provide for rules to determine the location of the debtor's assets, which should apply when determining which assets belong to the main or secondary insolvency proceedings, or to situations involving third parties' rights in rem. In particular, this Regulation should provide that European patents with unitary effect, a Community trade mark or any other similar rights, such as Community plant variety rights or Community designs, should only be included in the main insolvency proceedings. (40) Secondary insolvency proceedings can serve different purposes, besides the protection of local interests. Cases may arise in which the insolvency estate of the debtor is too complex to administer as a unit, or the differences in the legal systems concerned are so great that difficulties may arise from the extension of effects deriving from the law of the State of the opening of proceedings to the other Member States where the assets are located. For that reason, the insolvency practitioner in the main insolvency proceedings may request the opening of secondary insolvency proceedings where the efficient administration of the insolvency estate so requires. (41) Secondary insolvency proceedings may also hamper the efficient administration of the insolvency estate. Therefore, this Regulation sets out two specific situations in which the court seised of a request to open secondary insolvency proceedings should be able, at the request of the insolvency practitioner in the main insolvency proceedings, to postpone or refuse the opening of such proceedings. (42) First, this Regulation confers on the insolvency practitioner in main insolvency proceedings the possibility of giving an undertaking to local creditors that they will be treated as if secondary insolvency proceedings had been opened. That undertaking has to meet a number of conditions set out in this Regulation, in particular that it be approved by a qualified majority of local creditors. Where such an undertaking has been given, the court seised of a request to open secondary insolvency proceedings should be able to refuse that request if it is satisfied that the undertaking adequately protects the general interests of local creditors. When assessing those interests, the court should take into account the fact that the undertaking has been approved by a qualified majority of local creditors. (43) For the purposes of giving an undertaking to local creditors, the assets and rights located in the Member State where the debtor has an establishment should form a sub-category of the insolvency estate, and, when distributing them or the proceeds resulting from their realisation, the insolvency practitioner in the main insolvency proceedings should respect the priority rights that creditors would have had if secondary insolvency proceedings had been opened in that Member State. (44) National law should be applicable, as appropriate, in relation to the approval of an undertaking. In particular, where under national law the voting rules for adopting a restructuring plan require the prior approval of creditors' claims, those claims should be deemed to be approved for the purpose of voting on the undertaking. Where there are different procedures for the adoption of restructuring plans under national law, Member States should designate the specific procedure which should be relevant in this context. (45) Second, this Regulation should provide for the possibility that the court temporarily stays the opening of secondary insolvency proceedings, when a temporary stay of individual enforcement proceedings has been granted in the main insolvency proceedings, in order to preserve the efficiency of the stay granted in the main insolvency proceedings. The court should be able to grant the temporary stay if it is satisfied that suitable measures are in place to protect the general interest of local creditors. In such a case, all creditors that could be affected by the outcome of the negotiations on a restructuring plan should be informed of the negotiations and be allowed to participate in them. (46) In order to ensure effective protection of local interests, the insolvency practitioner in the main insolvency proceedings should not be able to realise or re-locate, in an abusive manner, assets situated in the Member State where an establishment is located, in particular, with the purpose of frustrating the possibility that such interests can be effectively satisfied if secondary insolvency proceedings are opened subsequently. (47) This Regulation should not prevent the courts of a Member State in which secondary insolvency proceedings have been opened from sanctioning a debtor's directors for violation of their duties, provided that those courts have jurisdiction to address such disputes under their national law. (48) Main insolvency proceedings and secondary insolvency proceedings can contribute to the efficient administration of the debtor's insolvency estate or to the effective realisation of the total assets if there is proper cooperation between the actors involved in all the concurrent proceedings. Proper cooperation implies the various insolvency practitioners and the courts involved cooperating closely, in particular by exchanging a sufficient amount of information. In order to ensure the dominant role of the main insolvency proceedings, the insolvency practitioner in such proceedings should be given several possibilities for intervening in secondary insolvency proceedings which are pending at the same time. In particular, the insolvency practitioner should be able to propose a restructuring plan or composition or apply for a suspension of the realisation of the assets in the secondary insolvency proceedings. When cooperating, insolvency practitioners and courts should take into account best practices for cooperation in cross-border insolvency cases, as set out in principles and guidelines on communication and cooperation adopted by European and international organisations active in the area of insolvency law, and in particular the relevant guidelines prepared by the United Nations Commission on International Trade Law (Uncitral). (49) In light of such cooperation, insolvency practitioners and courts should be able to enter into agreements and protocols for the purpose of facilitating cross-border cooperation of multiple insolvency proceedings in different Member States concerning the same debtor or members of the same group of companies, where this is compatible with the rules applicable to each of the proceedings. Such agreements and protocols may vary in form, in that they may be written or oral, and in scope, in that they may range from generic to specific, and may be entered into by different parties. Simple generic agreements may emphasise the need for close cooperation between the parties, without addressing specific issues, while more detailed, specific agreements may establish a framework of principles to govern multiple insolvency proceedings and may be approved by the courts involved, where the national law so requires. They may reflect an agreement between the parties to take, or to refrain from taking, certain steps or actions. (50) Similarly, the courts of different Member States may cooperate by coordinating the appointment of insolvency practitioners. In that context, they may appoint a single insolvency practitioner for several insolvency proceedings concerning the same debtor or for different members of a group of companies, provided that this is compatible with the rules applicable to each of the proceedings, in particular with any requirements concerning the qualification and licensing of the insolvency practitioner. (51) This Regulation should ensure the efficient administration of insolvency proceedings relating to different companies forming part of a group of companies. (52) Where insolvency proceedings have been opened for several companies of the same group, there should be proper cooperation between the actors involved in those proceedings. The various insolvency practitioners and the courts involved should therefore be under a similar obligation to cooperate and communicate with each other as those involved in main and secondary insolvency proceedings relating to the same debtor. Cooperation between the insolvency practitioners should not run counter to the interests of the creditors in each of the proceedings, and such cooperation should be aimed at finding a solution that would leverage synergies across the group. (53) The introduction of rules on the insolvency proceedings of groups of companies should not limit the possibility for a court to open insolvency proceedings for several companies belonging to the same group in a single jurisdiction if the court finds that the centre of main interests of those companies is located in a single Member State. In such cases, the court should also be able to appoint, if appropriate, the same insolvency practitioner in all proceedings concerned, provided that this is not incompatible with the rules applicable to them. (54) With a view to further improving the coordination of the insolvency proceedings of members of a group of companies, and to allow for a coordinated restructuring of the group, this Regulation should introduce procedural rules on the coordination of the insolvency proceedings of members of a group of companies. Such coordination should strive to ensure the efficiency of the coordination, whilst at the same time respecting each group member's separate legal personality. (55) An insolvency practitioner appointed in insolvency proceedings opened in relation to a member of a group of companies should be able to request the opening of group coordination proceedings. However, where the law applicable to the insolvency so requires, that insolvency practitioner should obtain the necessary authorisation before making such a request. The request should specify the essential elements of the coordination, in particular an outline of the coordination plan, a proposal as to whom should be appointed as coordinator and an outline of the estimated costs of the coordination. (56) In order to ensure the voluntary nature of group coordination proceedings, the insolvency practitioners involved should be able to object to their participation in the proceedings within a specified time period. In order to allow the insolvency practitioners involved to take an informed decision on participation in the group coordination proceedings, they should be informed at an early stage of the essential elements of the coordination. However, any insolvency practitioner who initially objects to inclusion in the group coordination proceedings should be able to subsequently request to participate in them. In such a case, the coordinator should take a decision on the admissibility of the request. All insolvency practitioners, including the requesting insolvency practitioner, should be informed of the coordinator's decision and should have the opportunity of challenging that decision before the court which has opened the group coordination proceedings. (57) Group coordination proceedings should always strive to facilitate the effective administration of the insolvency proceedings of the group members, and to have a generally positive impact for the creditors. This Regulation should therefore ensure that the court with which a request for group coordination proceedings has been filed makes an assessment of those criteria prior to opening group coordination proceedings. (58) The advantages of group coordination proceedings should not be outweighed by the costs of those proceedings. Therefore, it is necessary to ensure that the costs of the coordination, and the share of those costs that each group member will bear, are adequate, proportionate and reasonable, and are determined in accordance with the national law of the Member State in which group coordination proceedings have been opened. The insolvency practitioners involved should also have the possibility of controlling those costs from an early stage of the proceedings. Where the national law so requires, controlling costs from an early stage of proceedings could involve the insolvency practitioner seeking the approval of a court or creditors' committee. (59) Where the coordinator considers that the fulfilment of his or her tasks requires a significant increase in costs compared to the initially estimated costs and, in any case, where the costs exceed 10 % of the estimated costs, the coordinator should be authorised by the court which has opened the group coordination proceedings to exceed such costs. Before taking its decision, the court which has opened the group coordination proceedings should give the possibility to the participating insolvency practitioners to be heard before it in order to allow them to communicate their observations on the appropriateness of the coordinator's request. (60) For members of a group of companies which are not participating in group coordination proceedings, this Regulation should also provide for an alternative mechanism to achieve a coordinated restructuring of the group. An insolvency practitioner appointed in proceedings relating to a member of a group of companies should have standing to request a stay of any measure related to the realisation of the assets in the proceedings opened with respect to other members of the group which are not subject to group coordination proceedings. It should only be possible to request such a stay if a restructuring plan is presented for the members of the group concerned, if the plan is to the benefit of the creditors in the proceedings in respect of which the stay is requested, and if the stay is necessary to ensure that the plan can be properly implemented. (61) This Regulation should not prevent Member States from establishing national rules which would supplement the rules on cooperation, communication and coordination with regard to the insolvency of members of groups of companies set out in this Regulation, provided that the scope of application of those national rules is limited to the national jurisdiction and that their application would not impair the efficiency of the rules laid down by this Regulation. (62) The rules on cooperation, communication and coordination in the framework of the insolvency of members of a group of companies provided for in this Regulation should only apply to the extent that proceedings relating to different members of the same group of companies have been opened in more than one Member State. (63) Any creditor which has its habitual residence, domicile or registered office in the Union should have the right to lodge its claims in each of the insolvency proceedings pending in the Union relating to the debtor's assets. This should also apply to tax authorities and social insurance institutions. This Regulation should not prevent the insolvency practitioner from lodging claims on behalf of certain groups of creditors, for example employees, where the national law so provides. However, in order to ensure the equal treatment of creditors, the distribution of proceeds should be coordinated. Every creditor should be able to keep what it has received in the course of insolvency proceedings, but should be entitled only to participate in the distribution of total assets in other proceedings if creditors with the same standing have obtained the same proportion of their claims. (64) It is essential that creditors which have their habitual residence, domicile or registered office in the Union be informed about the opening of insolvency proceedings relating to their debtor's assets. In order to ensure a swift transmission of information to creditors, Regulation (EC) No 1393/2007 of the European Parliament and of the Council (6) should not apply where this Regulation refers to the obligation to inform creditors. The use of standard forms available in all official languages of the institutions of the Union should facilitate the task of creditors when lodging claims in proceedings opened in another Member State. The consequences of the incomplete filing of the standard forms should be a matter for national law. (65) This Regulation should provide for the immediate recognition of judgments concerning the opening, conduct and closure of insolvency proceedings which fall within its scope, and of judgments handed down in direct connection with such insolvency proceedings. Automatic recognition should therefore mean that the effects attributed to the proceedings by the law of the Member State in which the proceedings were opened extend to all other Member States. The recognition of judgments delivered by the courts of the Member States should be based on the principle of mutual trust. To that end, grounds for non-recognition should be reduced to the minimum necessary. This is also the basis on which any dispute should be resolved where the courts of two Member States both claim competence to open the main insolvency proceedings. The decision of the first court to open proceedings should be recognised in the other Member States without those Member States having the power to scrutinise that court's decision. (66) This Regulation should set out, for the matters covered by it, uniform rules on conflict of laws which replace, within their scope of application, national rules of private international law. Unless otherwise stated, the law of the Member State of the opening of proceedings should be applicable (lex concursus). This rule on conflict of laws should be valid both for the main insolvency proceedings and for local proceedings. The lex concursus determines all the effects of the insolvency proceedings, both procedural and substantive, on the persons and legal relations concerned. It governs all the conditions for the opening, conduct and closure of the insolvency proceedings. (67) Automatic recognition of insolvency proceedings to which the law of the State of the opening of proceedings normally applies may interfere with the rules under which transactions are carried out in other Member States. To protect legitimate expectations and the certainty of transactions in Member States other than that in which proceedings are opened, provision should be made for a number of exceptions to the general rule. (68) There is a particular need for a special reference diverging from the law of the opening State in the case of rights in rem, since such rights are of considerable importance for the granting of credit. The basis, validity and extent of rights in rem should therefore normally be determined according to the lex situs and not be affected by the opening of insolvency proceedings. The proprietor of a right in rem should therefore be able to continue to assert its right to segregation or separate settlement of the collateral security. Where assets are subject to rights in rem under the lex situs in one Member State but the main insolvency proceedings are being carried out in another Member State, the insolvency practitioner in the main insolvency proceedings should be able to request the opening of secondary insolvency proceedings in the jurisdiction where the rights in rem arise if the debtor has an establishment there. If secondary insolvency proceedings are not opened, any surplus on the sale of an asset covered by rights in rem should be paid to the insolvency practitioner in the main insolvency proceedings. (69) This Regulation lays down several provisions for a court to order a stay of opening proceedings or a stay of enforcement proceedings. Any such stay should not affect the rights in rem of creditors or third parties. (70) If a set-off of claims is not permitted under the law of the State of the opening of proceedings, a creditor should nevertheless be entitled to the set-off if it is possible under the law applicable to the claim of the insolvent debtor. In this way, set-off would acquire a kind of guarantee function based on legal provisions on which the creditor concerned can rely at the time when the claim arises. (71) There is also a need for special protection in the case of payment systems and financial markets, for example in relation to the position-closing agreements and netting agreements to be found in such systems, as well as the sale of securities and the guarantees provided for such transactions as governed in particular by Directive 98/26/EC of the European Parliament and of the Council (7). For such transactions, the only law which is relevant should be that applicable to the system or market concerned. That law is intended to prevent the possibility of mechanisms for the payment and settlement of transactions, and provided for in payment and set-off systems or on the regulated financial markets of the Member States, being altered in the case of insolvency of a business partner. Directive 98/26/EC contains special provisions which should take precedence over the general rules laid down in this Regulation. (72) In order to protect employees and jobs, the effects of insolvency proceedings on the continuation or termination of employment and on the rights and obligations of all parties to such employment should be determined by the law applicable to the relevant employment agreement, in accordance with the general rules on conflict of laws. Moreover, in cases where the termination of employment contracts requires approval by a court or administrative authority, the Member State in which an establishment of the debtor is located should retain jurisdiction to grant such approval even if no insolvency proceedings have been opened in that Member State. Any other questions relating to the law of insolvency, such as whether the employees' claims are protected by preferential rights and the status such preferential rights may have, should be determined by the law of the Member State in which the insolvency proceedings (main or secondary) have been opened, except in cases where an undertaking to avoid secondary insolvency proceedings has been given in accordance with this Regulation. (73) The law applicable to the effects of insolvency proceedings on any pending lawsuit or pending arbitral proceedings concerning an asset or right which forms part of the debtor's insolvency estate should be the law of the Member State where the lawsuit is pending or where the arbitration has its seat. However, this rule should not affect national rules on recognition and enforcement of arbitral awards. (74) In order to take account of the specific procedural rules of court systems in certain Member States flexibility should be provided with regard to certain rules of this Regulation. Accordingly, references in this Regulation to notice being given by a judicial body of a Member State should include, where a Member State's procedural rules so require, an order by that judicial body directing that notice be given. (75) For business considerations, the main content of the decision opening the proceedings should be published, at the request of the insolvency practitioner, in a Member State other than that of the court which delivered that decision. If there is an establishment in the Member State concerned, such publication should be mandatory. In neither case, however, should publication be a prior condition for recognition of the foreign proceedings. (76) In order to improve the provision of information to relevant creditors and courts and to prevent the opening of parallel insolvency proceedings, Member States should be required to publish relevant information in cross-border insolvency cases in a publicly accessible electronic register. In order to facilitate access to that information for creditors and courts domiciled or located in other Member States, this Regulation should provide for the interconnection of such insolvency registers via the European e-Justice Portal. Member States should be free to publish relevant information in several registers and it should be possible to interconnect more than one register per Member State. (77) This Regulation should determine the minimum amount of information to be published in the insolvency registers. Member States should not be precluded from including additional information. Where the debtor is an individual, the insolvency registers should only have to indicate a registration number if the debtor is exercising an independent business or professional activity. That registration number should be understood to be the unique registration number of the debtor's independent business or professional activity published in the trade register, if any. (78) Information on certain aspects of insolvency proceedings is essential for creditors, such as time limits for lodging claims or for challenging decisions. This Regulation should, however, not require Member States to calculate those time-limits on a case-by-case basis. Member States should be able to fulfil their obligations by adding hyperlinks to the European e-Justice Portal, where self-explanatory information on the criteria for calculating those time-limits is to be provided. (79) In order to grant sufficient protection to information relating to individuals not exercising an independent business or professional activity, Member States should be able to make access to that information subject to supplementary search criteria such as the debtor's personal identification number, address, date of birth or the district of the competent court, or to make access conditional upon a request to a competent authority or upon the verification of a legitimate interest. (80) Member States should also be able not to include in their insolvency registers information on individuals not exercising an independent business or professional activity. In such cases, Member States should ensure that the relevant information is given to the creditors by individual notice, and that claims of creditors who have not received the information are not affected by the proceedings. (81) It may be the case that some of the persons concerned are not aware that insolvency proceedings have been opened, and act in good faith in a way that conflicts with the new circumstances. In order to protect such persons who, unaware that foreign proceedings have been opened, make a payment to the debtor instead of to the foreign insolvency practitioner, provision should be made for such a payment to have a debt-discharging effect. (82) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (8). (83) This Regulation respects the fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to promote the application of Articles 8, 17 and 47 concerning, respectively, the protection of personal data, the right to property and the right to an effective remedy and to a fair trial. (84) Directive 95/46/EC of the European Parliament and of the Council (9) and Regulation (EC) No 45/2001 of the European Parliament and of the Council (10) apply to the processing of personal data within the framework of this Regulation. (85) This Regulation is without prejudice to Regulation (EEC, Euratom) No 1182/71 of the Council (11). (86) Since the objective of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the creation of a legal framework for the proper administration of cross-border insolvency proceedings, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (87) In accordance with Article 3 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, the United Kingdom and Ireland have notified their wish to take part in the adoption and application of this Regulation. (88) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (89) The European Data Protection Supervisor was consulted and delivered an opinion on 27 March 2013 (12), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Scope 1. This Regulation shall apply to public collective proceedings, including interim proceedings, which are based on laws relating to insolvency and in which, for the purpose of rescue, adjustment of debt, reorganisation or liquidation: (a) a debtor is totally or partially divested of its assets and an insolvency practitioner is appointed; (b) the assets and affairs of a debtor are subject to control or supervision by a court; or (c) a temporary stay of individual enforcement proceedings is granted by a court or by operation of law, in order to allow for negotiations between the debtor and its creditors, provided that the proceedings in which the stay is granted provide for suitable measures to protect the general body of creditors, and, where no agreement is reached, are preliminary to one of the proceedings referred to in point (a) or (b). Where the proceedings referred to in this paragraph may be commenced in situations where there is only a likelihood of insolvency, their purpose shall be to avoid the debtor's insolvency or the cessation of the debtor's business activities. The proceedings referred to in this paragraph are listed in Annex A. 2. This Regulation shall not apply to proceedings referred to in paragraph 1 that concern: (a) insurance undertakings; (b) credit institutions; (c) investment firms and other firms, institutions and undertakings to the extent that they are covered by Directive 2001/24/EC; or (d) collective investment undertakings. Article 2 Definitions For the purposes of this Regulation: (1) \u2018collective proceedings\u2019 means proceedings which include all or a significant part of a debtor's creditors, provided that, in the latter case, the proceedings do not affect the claims of creditors which are not involved in them; (2) \u2018collective investment undertakings\u2019 means undertakings for collective investment in transferable securities (UCITS) as defined in Directive 2009/65/EC of the European Parliament and of the Council (13) and alternative investment funds (AIFs) as defined in Directive 2011/61/EU of the European Parliament and of the Council (14); (3) \u2018debtor in possession\u2019 means a debtor in respect of which insolvency proceedings have been opened which do not necessarily involve the appointment of an insolvency practitioner or the complete transfer of the rights and duties to administer the debtor's assets to an insolvency practitioner and where, therefore, the debtor remains totally or at least partially in control of its assets and affairs; (4) \u2018insolvency proceedings\u2019 means the proceedings listed in Annex A; (5) \u2018insolvency practitioner\u2019 means any person or body whose function, including on an interim basis, is to: (i) verify and admit claims submitted in insolvency proceedings; (ii) represent the collective interest of the creditors; (iii) administer, either in full or in part, assets of which the debtor has been divested; (iv) liquidate the assets referred to in point (iii); or (v) supervise the administration of the debtor's affairs. The persons and bodies referred to in the first subparagraph are listed in Annex B; (6) \u2018court\u2019 means: (i) in points (b) and (c) of Article 1(1), Article 4(2), Articles 5 and 6, Article 21(3), point (j) of Article 24(2), Articles 36 and 39, and Articles 61 to 77, the judicial body of a Member State; (ii) in all other articles, the judicial body or any other competent body of a Member State empowered to open insolvency proceedings, to confirm such opening or to take decisions in the course of such proceedings; (7) \u2018judgment opening insolvency proceedings\u2019 includes: (i) the decision of any court to open insolvency proceedings or to confirm the opening of such proceedings; and (ii) the decision of a court to appoint an insolvency practitioner; (8) \u2018the time of the opening of proceedings\u2019 means the time at which the judgment opening insolvency proceedings becomes effective, regardless of whether the judgment is final or not; (9) \u2018the Member State in which assets are situated\u2019 means, in the case of: (i) registered shares in companies other than those referred to in point (ii), the Member State within the territory of which the company having issued the shares has its registered office; (ii) financial instruments, the title to which is evidenced by entries in a register or account maintained by or on behalf of an intermediary (\u2018book entry securities\u2019), the Member State in which the register or account in which the entries are made is maintained; (iii) cash held in accounts with a credit institution, the Member State indicated in the account's IBAN, or, for cash held in accounts with a credit institution which does not have an IBAN, the Member State in which the credit institution holding the account has its central administration or, where the account is held with a branch, agency or other establishment, the Member State in which the branch, agency or other establishment is located; (iv) property and rights, ownership of or entitlement to which is entered in a public register other than those referred to in point (i), the Member State under the authority of which the register is kept; (v) European patents, the Member State for which the European patent is granted; (vi) copyright and related rights, the Member State within the territory of which the owner of such rights has its habitual residence or registered office; (vii) tangible property, other than that referred to in points (i) to (iv), the Member State within the territory of which the property is situated; (viii) claims against third parties, other than those relating to assets referred to in point (iii), the Member State within the territory of which the third party required to meet the claims has the centre of its main interests, as determined in accordance with Article 3(1); (10) \u2018establishment\u2019 means any place of operations where a debtor carries out or has carried out in the 3-month period prior to the request to open main insolvency proceedings a non-transitory economic activity with human means and assets; (11) \u2018local creditor\u2019 means a creditor whose claims against a debtor arose from or in connection with the operation of an establishment situated in a Member State other than the Member State in which the centre of the debtor's main interests is located; (12) \u2018foreign creditor\u2019 means a creditor which has its habitual residence, domicile or registered office in a Member State other than the State of the opening of proceedings, including the tax authorities and social security authorities of Member States; (13) \u2018group of companies\u2019 means a parent undertaking and all its subsidiary undertakings; (14) \u2018parent undertaking\u2019 means an undertaking which controls, either directly or indirectly, one or more subsidiary undertakings. An undertaking which prepares consolidated financial statements in accordance with Directive 2013/34/EU of the European Parliament and of the Council (15) shall be deemed to be a parent undertaking. Article 3 International jurisdiction 1. The courts of the Member State within the territory of which the centre of the debtor's main interests is situated shall have jurisdiction to open insolvency proceedings (\u2018main insolvency proceedings\u2019). The centre of main interests shall be the place where the debtor conducts the administration of its interests on a regular basis and which is ascertainable by third parties. In the case of a company or legal person, the place of the registered office shall be presumed to be the centre of its main interests in the absence of proof to the contrary. That presumption shall only apply if the registered office has not been moved to another Member State within the 3-month period prior to the request for the opening of insolvency proceedings. In the case of an individual exercising an independent business or professional activity, the centre of main interests shall be presumed to be that individual's principal place of business in the absence of proof to the contrary. That presumption shall only apply if the individual's principal place of business has not been moved to another Member State within the 3-month period prior to the request for the opening of insolvency proceedings. In the case of any other individual, the centre of main interests shall be presumed to be the place of the individual's habitual residence in the absence of proof to the contrary. This presumption shall only apply if the habitual residence has not been moved to another Member State within the 6-month period prior to the request for the opening of insolvency proceedings. 2. Where the centre of the debtor's main interests is situated within the territory of a Member State, the courts of another Member State shall have jurisdiction to open insolvency proceedings against that debtor only if it possesses an establishment within the territory of that other Member State. The effects of those proceedings shall be restricted to the assets of the debtor situated in the territory of the latter Member State. 3. Where insolvency proceedings have been opened in accordance with paragraph 1, any proceedings opened subsequently in accordance with paragraph 2 shall be secondary insolvency proceedings. 4. The territorial insolvency proceedings referred to in paragraph 2 may only be opened prior to the opening of main insolvency proceedings in accordance with paragraph 1 where (a) insolvency proceedings under paragraph 1 cannot be opened because of the conditions laid down by the law of the Member State within the territory of which the centre of the debtor's main interests is situated; or (b) the opening of territorial insolvency proceedings is requested by: (i) a creditor whose claim arises from or is in connection with the operation of an establishment situated within the territory of the Member State where the opening of territorial proceedings is requested; or (ii) a public authority which, under the law of the Member State within the territory of which the establishment is situated, has the right to request the opening of insolvency proceedings. When main insolvency proceedings are opened, the territorial insolvency proceedings shall become secondary insolvency proceedings. Article 4 Examination as to jurisdiction 1. A court seised of a request to open insolvency proceedings shall of its own motion examine whether it has jurisdiction pursuant to Article 3. The judgment opening insolvency proceedings shall specify the grounds on which the jurisdiction of the court is based, and, in particular, whether jurisdiction is based on Article 3(1) or (2). 2. Notwithstanding paragraph 1, where insolvency proceedings are opened in accordance with national law without a decision by a court, Member States may entrust the insolvency practitioner appointed in such proceedings to examine whether the Member State in which a request for the opening of proceedings is pending has jurisdiction pursuant to Article 3. Where this is the case, the insolvency practitioner shall specify in the decision opening the proceedings the grounds on which jurisdiction is based and, in particular, whether jurisdiction is based on Article 3(1) or (2). Article 5 Judicial review of the decision to open main insolvency proceedings 1. The debtor or any creditor may challenge before a court the decision opening main insolvency proceedings on grounds of international jurisdiction. 2. The decision opening main insolvency proceedings may be challenged by parties other than those referred to in paragraph 1 or on grounds other than a lack of international jurisdiction where national law so provides. Article 6 Jurisdiction for actions deriving directly from insolvency proceedings and closely linked with them 1. The courts of the Member State within the territory of which insolvency proceedings have been opened in accordance with Article 3 shall have jurisdiction for any action which derives directly from the insolvency proceedings and is closely linked with them, such as avoidance actions. 2. Where an action referred to in paragraph 1 is related to an action in civil and commercial matters against the same defendant, the insolvency practitioner may bring both actions before the courts of the Member State within the territory of which the defendant is domiciled, or, where the action is brought against several defendants, before the courts of the Member State within the territory of which any of them is domiciled, provided that those courts have jurisdiction pursuant to Regulation (EU) No 1215/2012. The first subparagraph shall apply to the debtor in possession, provided that national law allows the debtor in possession to bring actions on behalf of the insolvency estate. 3. For the purpose of paragraph 2, actions are deemed to be related where they are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings. Article 7 Applicable law 1. Save as otherwise provided in this Regulation, the law applicable to insolvency proceedings and their effects shall be that of the Member State within the territory of which such proceedings are opened (the \u2018State of the opening of proceedings\u2019). 2. The law of the State of the opening of proceedings shall determine the conditions for the opening of those proceedings, their conduct and their closure. In particular, it shall determine the following: (a) the debtors against which insolvency proceedings may be brought on account of their capacity; (b) the assets which form part of the insolvency estate and the treatment of assets acquired by or devolving on the debtor after the opening of the insolvency proceedings; (c) the respective powers of the debtor and the insolvency practitioner; (d) the conditions under which set-offs may be invoked; (e) the effects of insolvency proceedings on current contracts to which the debtor is party; (f) the effects of the insolvency proceedings on proceedings brought by individual creditors, with the exception of pending lawsuits; (g) the claims which are to be lodged against the debtor's insolvency estate and the treatment of claims arising after the opening of insolvency proceedings; (h) the rules governing the lodging, verification and admission of claims; (i) the rules governing the distribution of proceeds from the realisation of assets, the ranking of claims and the rights of creditors who have obtained partial satisfaction after the opening of insolvency proceedings by virtue of a right in rem or through a set-off; (j) the conditions for, and the effects of closure of, insolvency proceedings, in particular by composition; (k) creditors' rights after the closure of insolvency proceedings; (l) who is to bear the costs and expenses incurred in the insolvency proceedings; (m) the rules relating to the voidness, voidability or unenforceability of legal acts detrimental to the general body of creditors. Article 8 Third parties' rights in rem 1. The opening of insolvency proceedings shall not affect the rights in rem of creditors or third parties in respect of tangible or intangible, moveable or immoveable assets, both specific assets and collections of indefinite assets as a whole which change from time to time, belonging to the debtor which are situated within the territory of another Member State at the time of the opening of proceedings. 2. The rights referred to in paragraph 1 shall, in particular, mean: (a) the right to dispose of assets or have them disposed of and to obtain satisfaction from the proceeds of or income from those assets, in particular by virtue of a lien or a mortgage; (b) the exclusive right to have a claim met, in particular a right guaranteed by a lien in respect of the claim or by assignment of the claim by way of a guarantee; (c) the right to demand assets from, and/or to require restitution by, anyone having possession or use of them contrary to the wishes of the party so entitled; (d) a right in rem to the beneficial use of assets. 3. The right, recorded in a public register and enforceable against third parties, based on which a right in rem within the meaning of paragraph 1 may be obtained shall be considered to be a right in rem. 4. Paragraph 1 shall not preclude actions for voidness, voidability or unenforceability as referred to in point (m) of Article 7(2). Article 9 Set-off 1. The opening of insolvency proceedings shall not affect the right of creditors to demand the set-off of their claims against the claims of a debtor, where such a set-off is permitted by the law applicable to the insolvent debtor's claim. 2. Paragraph 1 shall not preclude actions for voidness, voidability or unenforceability as referred to in point (m) of Article 7(2). Article 10 Reservation of title 1. The opening of insolvency proceedings against the purchaser of an asset shall not affect sellers' rights that are based on a reservation of title where at the time of the opening of proceedings the asset is situated within the territory of a Member State other than the State of the opening of proceedings. 2. The opening of insolvency proceedings against the seller of an asset, after delivery of the asset, shall not constitute grounds for rescinding or terminating the sale and shall not prevent the purchaser from acquiring title where at the time of the opening of proceedings the asset sold is situated within the territory of a Member State other than the State of the opening of proceedings. 3. Paragraphs 1 and 2 shall not preclude actions for voidness, voidability or unenforceability as referred to in point (m) of Article 7(2). Article 11 Contracts relating to immoveable property 1. The effects of insolvency proceedings on a contract conferring the right to acquire or make use of immoveable property shall be governed solely by the law of the Member State within the territory of which the immoveable property is situated. 2. The court which opened main insolvency proceedings shall have jurisdiction to approve the termination or modification of the contracts referred to in this Article where: (a) the law of the Member State applicable to those contracts requires that such a contract may only be terminated or modified with the approval of the court opening insolvency proceedings; and (b) no insolvency proceedings have been opened in that Member State. Article 12 Payment systems and financial markets 1. Without prejudice to Article 8, the effects of insolvency proceedings on the rights and obligations of the parties to a payment or settlement system or to a financial market shall be governed solely by the law of the Member State applicable to that system or market. 2. Paragraph 1 shall not preclude any action for voidness, voidability or unenforceability which may be taken to set aside payments or transactions under the law applicable to the relevant payment system or financial market. Article 13 Contracts of employment 1. The effects of insolvency proceedings on employment contracts and relationships shall be governed solely by the law of the Member State applicable to the contract of employment. 2. The courts of the Member State in which secondary insolvency proceedings may be opened shall retain jurisdiction to approve the termination or modification of the contracts referred to in this Article even if no insolvency proceedings have been opened in that Member State. The first subparagraph shall also apply to an authority competent under national law to approve the termination or modification of the contracts referred to in this Article. Article 14 Effects on rights subject to registration The effects of insolvency proceedings on the rights of a debtor in immoveable property, a ship or an aircraft subject to registration in a public register shall be determined by the law of the Member State under the authority of which the register is kept. Article 15 European patents with unitary effect and Community trade marks For the purposes of this Regulation, a European patent with unitary effect, a Community trade mark or any other similar right established by Union law may be included only in the proceedings referred to in Article 3(1). Article 16 Detrimental acts Point (m) of Article 7(2) shall not apply where the person who benefited from an act detrimental to all the creditors provides proof that: (a) the act is subject to the law of a Member State other than that of the State of the opening of proceedings; and (b) the law of that Member State does not allow any means of challenging that act in the relevant case. Article 17 Protection of third-party purchasers Where, by an act concluded after the opening of insolvency proceedings, a debtor disposes, for consideration, of: (a) an immoveable asset; (b) a ship or an aircraft subject to registration in a public register; or (c) securities the existence of which requires registration in a register laid down by law; the validity of that act shall be governed by the law of the State within the territory of which the immoveable asset is situated or under the authority of which the register is kept. Article 18 Effects of insolvency proceedings on pending lawsuits or arbitral proceedings The effects of insolvency proceedings on a pending lawsuit or pending arbitral proceedings concerning an asset or a right which forms part of a debtor's insolvency estate shall be governed solely by the law of the Member State in which that lawsuit is pending or in which the arbitral tribunal has its seat. CHAPTER II RECOGNITION OF INSOLVENCY PROCEEDINGS Article 19 Principle 1. Any judgment opening insolvency proceedings handed down by a court of a Member State which has jurisdiction pursuant to Article 3 shall be recognised in all other Member States from the moment that it becomes effective in the State of the opening of proceedings. The rule laid down in the first subparagraph shall also apply where, on account of a debtor's capacity, insolvency proceedings cannot be brought against that debtor in other Member States. 2. Recognition of the proceedings referred to in Article 3(1) shall not preclude the opening of the proceedings referred to in Article 3(2) by a court in another Member State. The latter proceedings shall be secondary insolvency proceedings within the meaning of Chapter III. Article 20 Effects of recognition 1. The judgment opening insolvency proceedings as referred to in Article 3(1) shall, with no further formalities, produce the same effects in any other Member State as under the law of the State of the opening of proceedings, unless this Regulation provides otherwise and as long as no proceedings referred to in Article 3(2) are opened in that other Member State. 2. The effects of the proceedings referred to in Article 3(2) may not be challenged in other Member States. Any restriction of creditors' rights, in particular a stay or discharge, shall produce effects vis-\u00e0-vis assets situated within the territory of another Member State only in the case of those creditors who have given their consent. Article 21 Powers of the insolvency practitioner 1. The insolvency practitioner appointed by a court which has jurisdiction pursuant to Article 3(1) may exercise all the powers conferred on it, by the law of the State of the opening of proceedings, in another Member State, as long as no other insolvency proceedings have been opened there and no preservation measure to the contrary has been taken there further to a request for the opening of insolvency proceedings in that State. Subject to Articles 8 and 10, the insolvency practitioner may, in particular, remove the debtor's assets from the territory of the Member State in which they are situated. 2. The insolvency practitioner appointed by a court which has jurisdiction pursuant to Article 3(2) may in any other Member State claim through the courts or out of court that moveable property was removed from the territory of the State of the opening of proceedings to the territory of that other Member State after the opening of the insolvency proceedings. The insolvency practitioner may also bring any action to set aside which is in the interests of the creditors. 3. In exercising its powers, the insolvency practitioner shall comply with the law of the Member State within the territory of which it intends to take action, in particular with regard to procedures for the realisation of assets. Those powers may not include coercive measures, unless ordered by a court of that Member State, or the right to rule on legal proceedings or disputes. Article 22 Proof of the insolvency practitioner's appointment The insolvency practitioner's appointment shall be evidenced by a certified copy of the original decision appointing it or by any other certificate issued by the court which has jurisdiction. A translation into the official language or one of the official languages of the Member State within the territory of which it intends to act may be required. No legalisation or other similar formality shall be required. Article 23 Return and imputation 1. A creditor which, after the opening of the proceedings referred to in Article 3(1), obtains by any means, in particular through enforcement, total or partial satisfaction of its claim on the assets belonging to a debtor situated within the territory of another Member State, shall return what it has obtained to the insolvency practitioner, subject to Articles 8 and 10. 2. In order to ensure the equal treatment of creditors, a creditor which has, in the course of insolvency proceedings, obtained a dividend on its claim shall share in distributions made in other proceedings only where creditors of the same ranking or category have, in those other proceedings, obtained an equivalent dividend. Article 24 Establishment of insolvency registers 1. Member States shall establish and maintain in their territory one or several registers in which information concerning insolvency proceedings is published (\u2018insolvency registers\u2019). That information shall be published as soon as possible after the opening of such proceedings. 2. The information referred to in paragraph 1 shall be made publicly available, subject to the conditions laid down in Article 27, and shall include the following (\u2018mandatory information\u2019): (a) the date of the opening of insolvency proceedings; (b) the court opening insolvency proceedings and the case reference number, if any; (c) the type of insolvency proceedings referred to in Annex A that were opened and, where applicable, any relevant subtype of such proceedings opened in accordance with national law; (d) whether jurisdiction for opening proceedings is based on Article 3(1), 3(2) or 3(4); (e) if the debtor is a company or a legal person, the debtor's name, registration number, registered office or, if different, postal address; (f) if the debtor is an individual whether or not exercising an independent business or professional activity, the debtor's name, registration number, if any, and postal address or, where the address is protected, the debtor's place and date of birth; (g) the name, postal address or e-mail address of the insolvency practitioner, if any, appointed in the proceedings; (h) the time limit for lodging claims, if any, or a reference to the criteria for calculating that time limit; (i) the date of closing main insolvency proceedings, if any; (j) the court before which and, where applicable, the time limit within which a challenge of the decision opening insolvency proceedings is to be lodged in accordance with Article 5, or a reference to the criteria for calculating that time limit. 3. Paragraph 2 shall not preclude Member States from including documents or additional information in their national insolvency registers, such as directors' disqualifications related to insolvency. 4. Member States shall not be obliged to include in the insolvency registers the information referred to in paragraph 1 of this Article in relation to individuals not exercising an independent business or professional activity, or to make such information publicly available through the system of interconnection of those registers, provided that known foreign creditors are informed, pursuant to Article 54, of the elements referred to under point (j) of paragraph 2 of this Article. Where a Member State makes use of the possibility referred to in the first subparagraph, the insolvency proceedings shall not affect the claims of foreign creditors who have not received the information referred to in the first subparagraph. 5. The publication of information in the registers under this Regulation shall not have any legal effects other than those set out in national law and in Article 55(6). Article 25 Interconnection of insolvency registers 1. The Commission shall establish a decentralised system for the interconnection of insolvency registers by means of implementing acts. That system shall be composed of the insolvency registers and the European e-Justice Portal, which shall serve as a central public electronic access point to information in the system. The system shall provide a search service in all the official languages of the institutions of the Union in order to make available the mandatory information and any other documents or information included in the insolvency registers which the Member States choose to make available through the European e-Justice Portal. 2. By means of implementing acts in accordance with the procedure referred to in Article 87, the Commission shall adopt the following by 26 June 2019: (a) the technical specification defining the methods of communication and information exchange by electronic means on the basis of the established interface specification for the system of interconnection of insolvency registers; (b) the technical measures ensuring the minimum information technology security standards for communication and distribution of information within the system of interconnection of insolvency registers; (c) minimum criteria for the search service provided by the European e-Justice Portal based on the information set out in Article 24; (d) minimum criteria for the presentation of the results of such searches based on the information set out in Article 24; (e) the means and the technical conditions of availability of services provided by the system of interconnection; and (f) a glossary containing a basic explanation of the national insolvency proceedings listed in Annex A. Article 26 Costs of establishing and interconnecting insolvency registers 1. The establishment, maintenance and future development of the system of interconnection of insolvency registers shall be financed from the general budget of the Union. 2. Each Member State shall bear the costs of establishing and adjusting its national insolvency registers to make them interoperable with the European e-Justice Portal, as well as the costs of administering, operating and maintaining those registers. This shall be without prejudice to the possibility to apply for grants to support such activities under the Union's financial programmes. Article 27 Conditions of access to information via the system of interconnection 1. Member States shall ensure that the mandatory information referred to in points (a) to (j) of Article 24(2) is available free of charge via the system of interconnection of insolvency registers. 2. This Regulation shall not preclude Member States from charging a reasonable fee for access to the documents or additional information referred to in Article 24(3) via the system of interconnection of insolvency registers. 3. Member States may make access to mandatory information concerning individuals who are not exercising an independent business or professional activity, and concerning individuals exercising an independent business or professional activity when the insolvency proceedings are not related to that activity, subject to supplementary search criteria relating to the debtor in addition to the minimum criteria referred to in point (c) of Article 25(2). 4. Member States may require that access to the information referred to in paragraph 3 be made conditional upon a request to the competent authority. Member States may make access conditional upon the verification of the existence of a legitimate interest for accessing such information. The requesting person shall be able to submit the request for information electronically by means of a standard form via the European e-Justice Portal. Where a legitimate interest is required, it shall be permissible for the requesting person to justify his request by electronic copies of relevant documents. The requesting person shall be provided with an answer by the competent authority within 3 working days. The requesting person shall not be obliged to provide translations of the documents justifying his request, or to bear any costs of translation which the competent authority may incur. Article 28 Publication in another Member State 1. The insolvency practitioner or the debtor in possession shall request that notice of the judgment opening insolvency proceedings and, where appropriate, the decision appointing the insolvency practitioner be published in any other Member State where an establishment of the debtor is located in accordance with the publication procedures provided for in that Member State. Such publication shall specify, where appropriate, the insolvency practitioner appointed and whether the jurisdiction rule applied is that pursuant to Article 3(1) or (2). 2. The insolvency practitioner or the debtor in possession may request that the information referred to in paragraph 1 be published in any other Member State where the insolvency practitioner or the debtor in possession deems it necessary in accordance with the publication procedures provided for in that Member State. Article 29 Registration in public registers of another Member State 1. Where the law of a Member State in which an establishment of the debtor is located and this establishment has been entered into a public register of that Member State, or the law of a Member State in which immovable property belonging to the debtor is located, requires information on the opening of insolvency proceedings referred to in Article 28 to be published in the land register, company register or any other public register, the insolvency practitioner or the debtor in possession shall take all the necessary measures to ensure such a registration. 2. The insolvency practitioner or the debtor in possession may request such registration in any other Member State, provided that the law of the Member State where the register is kept allows such registration. Article 30 Costs The costs of the publication and registration provided for in Articles 28 and 29 shall be regarded as costs and expenses incurred in the proceedings. Article 31 Honouring of an obligation to a debtor 1. Where an obligation has been honoured in a Member State for the benefit of a debtor who is subject to insolvency proceedings opened in another Member State, when it should have been honoured for the benefit of the insolvency practitioner in those proceedings, the person honouring the obligation shall be deemed to have discharged it if he was unaware of the opening of the proceedings. 2. Where such an obligation is honoured before the publication provided for in Article 28 has been effected, the person honouring the obligation shall be presumed, in the absence of proof to the contrary, to have been unaware of the opening of insolvency proceedings. Where the obligation is honoured after such publication has been effected, the person honouring the obligation shall be presumed, in the absence of proof to the contrary, to have been aware of the opening of proceedings. Article 32 Recognition and enforceability of other judgments 1. Judgments handed down by a court whose judgment concerning the opening of proceedings is recognised in accordance with Article 19 and which concern the course and closure of insolvency proceedings, and compositions approved by that court, shall also be recognised with no further formalities. Such judgments shall be enforced in accordance with Articles 39 to 44 and 47 to 57 of Regulation (EU) No 1215/2012. The first subparagraph shall also apply to judgments deriving directly from the insolvency proceedings and which are closely linked with them, even if they were handed down by another court. The first subparagraph shall also apply to judgments relating to preservation measures taken after the request for the opening of insolvency proceedings or in connection with it. 2. The recognition and enforcement of judgments other than those referred to in paragraph 1 of this Article shall be governed by Regulation (EU) No 1215/2012 provided that that Regulation is applicable. Article 33 Public policy Any Member State may refuse to recognise insolvency proceedings opened in another Member State or to enforce a judgment handed down in the context of such proceedings where the effects of such recognition or enforcement would be manifestly contrary to that State's public policy, in particular its fundamental principles or the constitutional rights and liberties of the individual. CHAPTER III SECONDARY INSOLVENCY PROCEEDINGS Article 34 Opening of proceedings Where main insolvency proceedings have been opened by a court of a Member State and recognised in another Member State, a court of that other Member State which has jurisdiction pursuant to Article 3(2) may open secondary insolvency proceedings in accordance with the provisions set out in this Chapter. Where the main insolvency proceedings required that the debtor be insolvent, the debtor's insolvency shall not be re-examined in the Member State in which secondary insolvency proceedings may be opened. The effects of secondary insolvency proceedings shall be restricted to the assets of the debtor situated within the territory of the Member State in which those proceedings have been opened. Article 35 Applicable law Save as otherwise provided for in this Regulation, the law applicable to secondary insolvency proceedings shall be that of the Member State within the territory of which the secondary insolvency proceedings are opened. Article 36 Right to give an undertaking in order to avoid secondary insolvency proceedings 1. In order to avoid the opening of secondary insolvency proceedings, the insolvency practitioner in the main insolvency proceedings may give a unilateral undertaking (the \u2018undertaking\u2019) in respect of the assets located in the Member State in which secondary insolvency proceedings could be opened, that when distributing those assets or the proceeds received as a result of their realisation, it will comply with the distribution and priority rights under national law that creditors would have if secondary insolvency proceedings were opened in that Member State. The undertaking shall specify the factual assumptions on which it is based, in particular in respect of the value of the assets located in the Member State concerned and the options available to realise such assets. 2. Where an undertaking has been given in accordance with this Article, the law applicable to the distribution of proceeds from the realisation of assets referred to in paragraph 1, to the ranking of creditors' claims, and to the rights of creditors in relation to the assets referred to in paragraph 1 shall be the law of the Member State in which secondary insolvency proceedings could have been opened. The relevant point in time for determining the assets referred to in paragraph 1 shall be the moment at which the undertaking is given. 3. The undertaking shall be made in the official language or one of the official languages of the Member State where secondary insolvency proceedings could have been opened, or, where there are several official languages in that Member State, the official language or one of the official languages of the place in which secondary insolvency proceedings could have been opened. 4. The undertaking shall be made in writing. It shall be subject to any other requirements relating to form and approval requirements as to distributions, if any, of the State of the opening of the main insolvency proceedings. 5. The undertaking shall be approved by the known local creditors. The rules on qualified majority and voting that apply to the adoption of restructuring plans under the law of the Member State where secondary insolvency proceedings could have been opened shall also apply to the approval of the undertaking. Creditors shall be able to participate in the vote by distance means of communication, where national law so permits. The insolvency practitioner shall inform the known local creditors of the undertaking, of the rules and procedures for its approval, and of the approval or rejection of the undertaking. 6. An undertaking given and approved in accordance with this Article shall be binding on the estate. If secondary insolvency proceedings are opened in accordance with Articles 37 and 38, the insolvency practitioner in the main insolvency proceedings shall transfer any assets which it removed from the territory of that Member State after the undertaking was given or, where those assets have already been realised, their proceeds, to the insolvency practitioner in the secondary insolvency proceedings. 7. Where the insolvency practitioner has given an undertaking, it shall inform local creditors about the intended distributions prior to distributing the assets and proceeds referred to in paragraph 1. If that information does not comply with the terms of the undertaking or the applicable law, any local creditor may challenge such distribution before the courts of the Member State in which main insolvency proceedings have been opened in order to obtain a distribution in accordance with the terms of the undertaking and the applicable law. In such cases, no distribution shall take place until the court has taken a decision on the challenge. 8. Local creditors may apply to the courts of the Member State in which main insolvency proceedings have been opened, in order to require the insolvency practitioner in the main insolvency proceedings to take any suitable measures necessary to ensure compliance with the terms of the undertaking available under the law of the State of the opening of main insolvency proceedings. 9. Local creditors may also apply to the courts of the Member State in which secondary insolvency proceedings could have been opened in order to require the court to take provisional or protective measures to ensure compliance by the insolvency practitioner with the terms of the undertaking. 10. The insolvency practitioner shall be liable for any damage caused to local creditors as a result of its non-compliance with the obligations and requirements set out in this Article. 11. For the purpose of this Article, an authority which is established in the Member State where secondary insolvency proceedings could have been opened and which is obliged under Directive 2008/94/EC of the European Parliament and of the Council (16) to guarantee the payment of employees' outstanding claims resulting from contracts of employment or employment relationships shall be considered to be a local creditor, where the national law so provides. Article 37 Right to request the opening of secondary insolvency proceedings 1. The opening of secondary insolvency proceedings may be requested by: (a) the insolvency practitioner in the main insolvency proceedings; (b) any other person or authority empowered to request the opening of insolvency proceedings under the law of the Member State within the territory of which the opening of secondary insolvency proceedings is requested. 2. Where an undertaking has become binding in accordance with Article 36, the request for opening secondary insolvency proceedings shall be lodged within 30 days of having received notice of the approval of the undertaking. Article 38 Decision to open secondary insolvency proceedings 1. A court seised of a request to open secondary insolvency proceedings shall immediately give notice to the insolvency practitioner or the debtor in possession in the main insolvency proceedings and give it an opportunity to be heard on the request. 2. Where the insolvency practitioner in the main insolvency proceedings has given an undertaking in accordance with Article 36, the court referred to in paragraph 1 of this Article shall, at the request of the insolvency practitioner, not open secondary insolvency proceedings if it is satisfied that the undertaking adequately protects the general interests of local creditors. 3. Where a temporary stay of individual enforcement proceedings has been granted in order to allow for negotiations between the debtor and its creditors, the court, at the request of the insolvency practitioner or the debtor in possession, may stay the opening of secondary insolvency proceedings for a period not exceeding 3 months, provided that suitable measures are in place to protect the interests of local creditors. The court referred to in paragraph 1 may order protective measures to protect the interests of local creditors by requiring the insolvency practitioner or the debtor in possession not to remove or dispose of any assets which are located in the Member State where its establishment is located unless this is done in the ordinary course of business. The court may also order other measures to protect the interest of local creditors during a stay, unless this is incompatible with the national rules on civil procedure. The stay of the opening of secondary insolvency proceedings shall be lifted by the court of its own motion or at the request of any creditor if, during the stay, an agreement in the negotiations referred to in the first subparagraph has been concluded. The stay may be lifted by the court of its own motion or at the request of any creditor if the continuation of the stay is detrimental to the creditor's rights, in particular if the negotiations have been disrupted or it has become evident that they are unlikely to be concluded, or if the insolvency practitioner or the debtor in possession has infringed the prohibition on disposal of its assets or on removal of them from the territory of the Member State where the establishment is located. 4. At the request of the insolvency practitioner in the main insolvency proceedings, the court referred to in paragraph 1 may open a type of insolvency proceedings as listed in Annex A other than the type initially requested, provided that the conditions for opening that type of proceedings under national law are fulfilled and that that type of proceedings is the most appropriate as regards the interests of the local creditors and coherence between the main and secondary insolvency proceedings. The second sentence of Article 34 shall apply. Article 39 Judicial review of the decision to open secondary insolvency proceedings The insolvency practitioner in the main insolvency proceedings may challenge the decision to open secondary insolvency proceedings before the courts of the Member State in which secondary insolvency proceedings have been opened on the ground that the court did not comply with the conditions and requirements of Article 38. Article 40 Advance payment of costs and expenses Where the law of the Member State in which the opening of secondary insolvency proceedings is requested requires that the debtor's assets be sufficient to cover in whole or in part the costs and expenses of the proceedings, the court may, when it receives such a request, require the applicant to make an advance payment of costs or to provide appropriate security. Article 41 Cooperation and communication between insolvency practitioners 1. The insolvency practitioner in the main insolvency proceedings and the insolvency practitioner or practitioners in secondary insolvency proceedings concerning the same debtor shall cooperate with each other to the extent such cooperation is not incompatible with the rules applicable to the respective proceedings. Such cooperation may take any form, including the conclusion of agreements or protocols. 2. In implementing the cooperation set out in paragraph 1, the insolvency practitioners shall: (a) as soon as possible communicate to each other any information which may be relevant to the other proceedings, in particular any progress made in lodging and verifying claims and all measures aimed at rescuing or restructuring the debtor, or at terminating the proceedings, provided appropriate arrangements are made to protect confidential information; (b) explore the possibility of restructuring the debtor and, where such a possibility exists, coordinate the elaboration and implementation of a restructuring plan; (c) coordinate the administration of the realisation or use of the debtor's assets and affairs; the insolvency practitioner in the secondary insolvency proceedings shall give the insolvency practitioner in the main insolvency proceedings an early opportunity to submit proposals on the realisation or use of the assets in the secondary insolvency proceedings. 3. Paragraphs 1 and 2 shall apply mutatis mutandis to situations where, in the main or in the secondary insolvency proceedings or in any territorial insolvency proceedings concerning the same debtor and open at the same time, the debtor remains in possession of its assets. Article 42 Cooperation and communication between courts 1. In order to facilitate the coordination of main, territorial and secondary insolvency proceedings concerning the same debtor, a court before which a request to open insolvency proceedings is pending, or which has opened such proceedings, shall cooperate with any other court before which a request to open insolvency proceedings is pending, or which has opened such proceedings, to the extent that such cooperation is not incompatible with the rules applicable to each of the proceedings. For that purpose, the courts may, where appropriate, appoint an independent person or body acting on its instructions, provided that it is not incompatible with the rules applicable to them. 2. In implementing the cooperation set out in paragraph 1, the courts, or any appointed person or body acting on their behalf, as referred to in paragraph 1, may communicate directly with, or request information or assistance directly from, each other provided that such communication respects the procedural rights of the parties to the proceedings and the confidentiality of information. 3. The cooperation referred to in paragraph 1 may be implemented by any means that the court considers appropriate. It may, in particular, concern: (a) coordination in the appointment of the insolvency practitioners; (b) communication of information by any means considered appropriate by the court; (c) coordination of the administration and supervision of the debtor's assets and affairs; (d) coordination of the conduct of hearings; (e) coordination in the approval of protocols, where necessary. Article 43 Cooperation and communication between insolvency practitioners and courts 1. In order to facilitate the coordination of main, territorial and secondary insolvency proceedings opened in respect of the same debtor: (a) an insolvency practitioner in main insolvency proceedings shall cooperate and communicate with any court before which a request to open secondary insolvency proceedings is pending or which has opened such proceedings; (b) an insolvency practitioner in territorial or secondary insolvency proceedings shall cooperate and communicate with the court before which a request to open main insolvency proceedings is pending or which has opened such proceedings; and (c) an insolvency practitioner in territorial or secondary insolvency proceedings shall cooperate and communicate with the court before which a request to open other territorial or secondary insolvency proceedings is pending or which has opened such proceedings; to the extent that such cooperation and communication are not incompatible with the rules applicable to each of the proceedings and do not entail any conflict of interest. 2. The cooperation referred to in paragraph 1 may be implemented by any appropriate means, such as those set out in Article 42(3). Article 44 Costs of cooperation and communication The requirements laid down in Articles 42 and 43 shall not result in courts charging costs to each other for cooperation and communication. Article 45 Exercise of creditors' rights 1. Any creditor may lodge its claim in the main insolvency proceedings and in any secondary insolvency proceedings. 2. The insolvency practitioners in the main and any secondary insolvency proceedings shall lodge in other proceedings claims which have already been lodged in the proceedings for which they were appointed, provided that the interests of creditors in the latter proceedings are served by doing so, subject to the right of creditors to oppose such lodgement or to withdraw the lodgement of their claims where the law applicable so provides. 3. The insolvency practitioner in the main or secondary insolvency proceedings shall be entitled to participate in other proceedings on the same basis as a creditor, in particular by attending creditors' meetings. Article 46 Stay of the process of realisation of assets 1. The court which opened the secondary insolvency proceedings shall stay the process of realisation of assets in whole or in part on receipt of a request from the insolvency practitioner in the main insolvency proceedings. In such a case, it may require the insolvency practitioner in the main insolvency proceedings to take any suitable measure to guarantee the interests of the creditors in the secondary insolvency proceedings and of individual classes of creditors. Such a request from the insolvency practitioner may be rejected only if it is manifestly of no interest to the creditors in the main insolvency proceedings. Such a stay of the process of realisation of assets may be ordered for up to 3 months. It may be continued or renewed for similar periods. 2. The court referred to in paragraph 1 shall terminate the stay of the process of realisation of assets: (a) at the request of the insolvency practitioner in the main insolvency proceedings; (b) of its own motion, at the request of a creditor or at the request of the insolvency practitioner in the secondary insolvency proceedings if that measure no longer appears justified, in particular, by the interests of creditors in the main insolvency proceedings or in the secondary insolvency proceedings. Article 47 Power of the insolvency practitioner to propose restructuring plans 1. Where the law of the Member State where secondary insolvency proceedings have been opened allows for such proceedings to be closed without liquidation by a restructuring plan, a composition or a comparable measure, the insolvency practitioner in the main insolvency proceedings shall be empowered to propose such a measure in accordance with the procedure of that Member State. 2. Any restriction of creditors' rights arising from a measure referred to in paragraph 1 which is proposed in secondary insolvency proceedings, such as a stay of payment or discharge of debt, shall have no effect in respect of assets of a debtor that are not covered by those proceedings, without the consent of all the creditors having an interest. Article 48 Impact of closure of insolvency proceedings 1. Without prejudice to Article 49, the closure of insolvency proceedings shall not prevent the continuation of other insolvency proceedings concerning the same debtor which are still open at that point in time. 2. Where insolvency proceedings concerning a legal person or a company in the Member State of that person's or company's registered office would entail the dissolution of the legal person or of the company, that legal person or company shall not cease to exist until any other insolvency proceedings concerning the same debtor have been closed, or the insolvency practitioner or practitioners in such proceedings have given consent to the dissolution. Article 49 Assets remaining in the secondary insolvency proceedings If, by the liquidation of assets in the secondary insolvency proceedings, it is possible to meet all claims allowed under those proceedings, the insolvency practitioner appointed in those proceedings shall immediately transfer any assets remaining to the insolvency practitioner in the main insolvency proceedings. Article 50 Subsequent opening of the main insolvency proceedings Where the proceedings referred to in Article 3(1) are opened following the opening of the proceedings referred to in Article 3(2) in another Member State, Articles 41, 45, 46, 47 and 49 shall apply to those opened first, in so far as the progress of those proceedings so permits. Article 51 Conversion of secondary insolvency proceedings 1. At the request of the insolvency practitioner in the main insolvency proceedings, the court of the Member State in which secondary insolvency proceedings have been opened may order the conversion of the secondary insolvency proceedings into another type of insolvency proceedings listed in Annex A, provided that the conditions for opening that type of proceedings under national law are fulfilled and that that type of proceedings is the most appropriate as regards the interests of the local creditors and coherence between the main and secondary insolvency proceedings. 2. When considering the request referred to in paragraph 1, the court may seek information from the insolvency practitioners involved in both proceedings. Article 52 Preservation measures Where the court of a Member State which has jurisdiction pursuant to Article 3(1) appoints a temporary administrator in order to ensure the preservation of a debtor's assets, that temporary administrator shall be empowered to request any measures to secure and preserve any of the debtor's assets situated in another Member State, provided for under the law of that Member State, for the period between the request for the opening of insolvency proceedings and the judgment opening the proceedings. CHAPTER IV PROVISION OF INFORMATION FOR CREDITORS AND LODGEMENT OF THEIR CLAIMS Article 53 Right to lodge claims Any foreign creditor may lodge claims in insolvency proceedings by any means of communication, which are accepted by the law of the State of the opening of proceedings. Representation by a lawyer or another legal professional shall not be mandatory for the sole purpose of lodging of claims. Article 54 Duty to inform creditors 1. As soon as insolvency proceedings are opened in a Member State, the court of that State having jurisdiction or the insolvency practitioner appointed by that court shall immediately inform the known foreign creditors. 2. The information referred to in paragraph 1, provided by an individual notice, shall in particular include time limits, the penalties laid down with regard to those time limits, the body or authority empowered to accept the lodgement of claims and any other measures laid down. Such notice shall also indicate whether creditors whose claims are preferential or secured in rem need to lodge their claims. The notice shall also include a copy of the standard form for lodging of claims referred to in Article 55 or information on where that form is available. 3. The information referred to in paragraphs 1 and 2 of this Article shall be provided using the standard notice form to be established in accordance with Article 88. The form shall be published in the European e-Justice Portal and shall bear the heading \u2018Notice of insolvency proceedings\u2019 in all the official languages of the institutions of the Union. It shall be transmitted in the official language of the State of the opening of proceedings or, if there are several official languages in that Member State, in the official language or one of the official languages of the place where insolvency proceedings have been opened, or in another language which that State has indicated it can accept, in accordance with Article 55(5), if it can be assumed that that language is easier to understand for the foreign creditors. 4. In insolvency proceedings relating to an individual not exercising a business or professional activity, the use of the standard form referred to in this Article shall not be obligatory if creditors are not required to lodge their claims in order to have their claims taken into account in the proceedings. Article 55 Procedure for lodging claims 1. Any foreign creditor may lodge its claim using the standard claims form to be established in accordance with Article 88. The form shall bear the heading \u2018Lodgement of claims\u2019 in all the official languages of the institutions of the Union. 2. The standard claims form referred to in paragraph 1 shall include the following information: (a) the name, postal address, e-mail address, if any, personal identification number, if any, and bank details of the foreign creditor referred to in paragraph 1; (b) the amount of the claim, specifying the principal and, where applicable, interest and the date on which it arose and the date on which it became due, if different; (c) if interest is claimed, the interest rate, whether the interest is of a legal or contractual nature, the period of time for which the interest is claimed and the capitalised amount of interest; (d) if costs incurred in asserting the claim prior to the opening of proceedings are claimed, the amount and the details of those costs; (e) the nature of the claim; (f) whether any preferential creditor status is claimed and the basis of such a claim; (g) whether security in rem or a reservation of title is alleged in respect of the claim and if so, what assets are covered by the security interest being invoked, the date on which the security was granted and, where the security has been registered, the registration number; and (h) whether any set-off is claimed and, if so, the amounts of the mutual claims existing on the date when insolvency proceedings were opened, the date on which they arose and the amount net of set-off claimed. The standard claims form shall be accompanied by copies of any supporting documents. 3. The standard claims form shall indicate that the provision of information concerning the bank details and the personal identification number of the creditor referred to in point (a) of paragraph 2 is not compulsory. 4. When a creditor lodges its claim by means other than the standard form referred to in paragraph 1, the claim shall contain the information referred to in paragraph 2. 5. Claims may be lodged in any official language of the institutions of the Union. The court, the insolvency practitioner or the debtor in possession may require the creditor to provide a translation in the official language of the State of the opening of proceedings or, if there are several official languages in that Member State, in the official language or one of the official languages of the place where insolvency proceedings have been opened, or in another language which that Member State has indicated it can accept. Each Member State shall indicate whether it accepts any official language of the institutions of the Union other than its own for the purpose of the lodging of claims. 6. Claims shall be lodged within the period stipulated by the law of the State of the opening of proceedings. In the case of a foreign creditor, that period shall not be less than 30 days following the publication of the opening of insolvency proceedings in the insolvency register of the State of the opening of proceedings. Where a Member State relies on Article 24(4), that period shall not be less than 30 days following a creditor having been informed pursuant to Article 54. 7. Where the court, the insolvency practitioner or the debtor in possession has doubts in relation to a claim lodged in accordance with this Article, it shall give the creditor the opportunity to provide additional evidence on the existence and the amount of the claim. CHAPTER V INSOLVENCY PROCEEDINGS OF MEMBERS OF A GROUP OF COMPANIES SECTION 1 Cooperation and communication Article 56 Cooperation and communication between insolvency practitioners 1. Where insolvency proceedings relate to two or more members of a group of companies, an insolvency practitioner appointed in proceedings concerning a member of the group shall cooperate with any insolvency practitioner appointed in proceedings concerning another member of the same group to the extent that such cooperation is appropriate to facilitate the effective administration of those proceedings, is not incompatible with the rules applicable to such proceedings and does not entail any conflict of interest. That cooperation may take any form, including the conclusion of agreements or protocols. 2. In implementing the cooperation set out in paragraph 1, insolvency practitioners shall: (a) as soon as possible communicate to each other any information which may be relevant to the other proceedings, provided appropriate arrangements are made to protect confidential information; (b) consider whether possibilities exist for coordinating the administration and supervision of the affairs of the group members which are subject to insolvency proceedings, and if so, coordinate such administration and supervision; (c) consider whether possibilities exist for restructuring group members which are subject to insolvency proceedings and, if so, coordinate with regard to the proposal and negotiation of a coordinated restructuring plan. For the purposes of points (b) and (c), all or some of the insolvency practitioners referred to in paragraph 1 may agree to grant additional powers to an insolvency practitioner appointed in one of the proceedings where such an agreement is permitted by the rules applicable to each of the proceedings. They may also agree on the allocation of certain tasks amongst them, where such allocation of tasks is permitted by the rules applicable to each of the proceedings. Article 57 Cooperation and communication between courts 1. Where insolvency proceedings relate to two or more members of a group of companies, a court which has opened such proceedings shall cooperate with any other court before which a request to open proceedings concerning another member of the same group is pending or which has opened such proceedings to the extent that such cooperation is appropriate to facilitate the effective administration of the proceedings, is not incompatible with the rules applicable to them and does not entail any conflict of interest. For that purpose, the courts may, where appropriate, appoint an independent person or body to act on its instructions, provided that this is not incompatible with the rules applicable to them. 2. In implementing the cooperation set out in paragraph 1, courts, or any appointed person or body acting on their behalf, as referred to in paragraph 1, may communicate directly with each other, or request information or assistance directly from each other, provided that such communication respects the procedural rights of the parties to the proceedings and the confidentiality of information. 3. The cooperation referred to in paragraph 1 may be implemented by any means that the court considers appropriate. It may, in particular, concern: (a) coordination in the appointment of insolvency practitioners; (b) communication of information by any means considered appropriate by the court; (c) coordination of the administration and supervision of the assets and affairs of the members of the group; (d) coordination of the conduct of hearings; (e) coordination in the approval of protocols where necessary. Article 58 Cooperation and communication between insolvency practitioners and courts An insolvency practitioner appointed in insolvency proceedings concerning a member of a group of companies: (a) shall cooperate and communicate with any court before which a request for the opening of proceedings in respect of another member of the same group of companies is pending or which has opened such proceedings; and (b) may request information from that court concerning the proceedings regarding the other member of the group or request assistance concerning the proceedings in which he has been appointed; to the extent that such cooperation and communication are appropriate to facilitate the effective administration of the proceedings, do not entail any conflict of interest and are not incompatible with the rules applicable to them. Article 59 Costs of cooperation and communication in proceedings concerning members of a group of companies The costs of the cooperation and communication provided for in Articles 56 to 60 incurred by an insolvency practitioner or a court shall be regarded as costs and expenses incurred in the respective proceedings. Article 60 Powers of the insolvency practitioner in proceedings concerning members of a group of companies 1. An insolvency practitioner appointed in insolvency proceedings opened in respect of a member of a group of companies may, to the extent appropriate to facilitate the effective administration of the proceedings: (a) be heard in any of the proceedings opened in respect of any other member of the same group; (b) request a stay of any measure related to the realisation of the assets in the proceedings opened with respect to any other member of the same group, provided that: (i) a restructuring plan for all or some members of the group for which insolvency proceedings have been opened has been proposed under point (c) of Article 56(2) and presents a reasonable chance of success; (ii) such a stay is necessary in order to ensure the proper implementation of the restructuring plan; (iii) the restructuring plan would be to the benefit of the creditors in the proceedings for which the stay is requested; and (iv) neither the insolvency proceedings in which the insolvency practitioner referred to in paragraph 1 of this Article has been appointed nor the proceedings in respect of which the stay is requested are subject to coordination under Section 2 of this Chapter; (c) apply for the opening of group coordination proceedings in accordance with Article 61. 2. The court having opened proceedings referred to in point (b) of paragraph 1 shall stay any measure related to the realisation of the assets in the proceedings in whole or in part if it is satisfied that the conditions referred to in point (b) of paragraph 1 are fulfilled. Before ordering the stay, the court shall hear the insolvency practitioner appointed in the proceedings for which the stay is requested. Such a stay may be ordered for any period, not exceeding 3 months, which the court considers appropriate and which is compatible with the rules applicable to the proceedings. The court ordering the stay may require the insolvency practitioner referred to in paragraph 1 to take any suitable measure available under national law to guarantee the interests of the creditors in the proceedings. The court may extend the duration of the stay by such further period or periods as it considers appropriate and which are compatible with the rules applicable to the proceedings, provided that the conditions referred to in points (b)(ii) to (iv) of paragraph 1 continue to be fulfilled and that the total duration of the stay (the initial period together with any such extensions) does not exceed 6 months. SECTION 2 Coordination Subsection 1 Procedure Article 61 Request to open group coordination proceedings 1. Group coordination proceedings may be requested before any court having jurisdiction over the insolvency proceedings of a member of the group, by an insolvency practitioner appointed in insolvency proceedings opened in relation to a member of the group. 2. The request referred to in paragraph 1 shall be made in accordance with the conditions provided for by the law applicable to the proceedings in which the insolvency practitioner has been appointed. 3. The request referred to in paragraph 1 shall be accompanied by: (a) a proposal as to the person to be nominated as the group coordinator (\u2018the coordinator\u2019), details of his or her eligibility pursuant to Article 71, details of his or her qualifications and his or her written agreement to act as coordinator; (b) an outline of the proposed group coordination, and in particular the reasons why the conditions set out in Article 63(1) are fulfilled; (c) a list of the insolvency practitioners appointed in relation to the members of the group and, where relevant, the courts and competent authorities involved in the insolvency proceedings of the members of the group; (d) an outline of the estimated costs of the proposed group coordination and the estimation of the share of those costs to be paid by each member of the group. Article 62 Priority rule Without prejudice to Article 66, where the opening of group coordination proceedings is requested before courts of different Member States, any court other than the court first seised shall decline jurisdiction in favour of that court. Article 63 Notice by the court seised 1. The court seised of a request to open group coordination proceedings shall give notice as soon as possible of the request for the opening of group coordination proceedings and of the proposed coordinator to the insolvency practitioners appointed in relation to the members of the group as indicated in the request referred to in point (c) of Article 61(3), if it is satisfied that: (a) the opening of such proceedings is appropriate to facilitate the effective administration of the insolvency proceedings relating to the different group members; (b) no creditor of any group member expected to participate in the proceedings is likely to be financially disadvantaged by the inclusion of that member in such proceedings; and (c) the proposed coordinator fulfils the requirements laid down in Article 71. 2. The notice referred to in paragraph 1 of this Article shall list the elements referred to in points (a) to (d) of Article 61(3). 3. The notice referred to in paragraph 1 shall be sent by registered letter, attested by an acknowledgment of receipt. 4. The court seised shall give the insolvency practitioners involved the opportunity to be heard. Article 64 Objections by insolvency practitioners 1. An insolvency practitioner appointed in respect of any group member may object to: (a) the inclusion within group coordination proceedings of the insolvency proceedings in respect of which it has been appointed; or (b) the person proposed as a coordinator. 2. Objections pursuant to paragraph 1 of this Article shall be lodged with the court referred to in Article 63 within 30 days of receipt of notice of the request for the opening of group coordination proceedings by the insolvency practitioner referred to in paragraph 1 of this Article. The objection may be made by means of the standard form established in accordance with Article 88. 3. Prior to taking the decision to participate or not to participate in the coordination in accordance with point (a) of paragraph 1, an insolvency practitioner shall obtain any approval which may be required under the law of the State of the opening of proceedings for which it has been appointed. Article 65 Consequences of objection to the inclusion in group coordination 1. Where an insolvency practitioner has objected to the inclusion of the proceedings in respect of which it has been appointed in group coordination proceedings, those proceedings shall not be included in the group coordination proceedings. 2. The powers of the court referred to in Article 68 or of the coordinator arising from those proceedings shall have no effect as regards that member, and shall entail no costs for that member. Article 66 Choice of court for group coordination proceedings 1. Where at least two-thirds of all insolvency practitioners appointed in insolvency proceedings of the members of the group have agreed that a court of another Member State having jurisdiction is the most appropriate court for the opening of group coordination proceedings, that court shall have exclusive jurisdiction. 2. The choice of court shall be made by joint agreement in writing or evidenced in writing. It may be made until such time as group coordination proceedings have been opened in accordance with Article 68. 3. Any court other than the court seised under paragraph 1 shall decline jurisdiction in favour of that court. 4. The request for the opening of group coordination proceedings shall be submitted to the court agreed in accordance with Article 61. Article 67 Consequences of objections to the proposed coordinator Where objections to the person proposed as coordinator have been received from an insolvency practitioner which does not also object to the inclusion in the group coordination proceedings of the member in respect of which it has been appointed, the court may refrain from appointing that person and invite the objecting insolvency practitioner to submit a new request in accordance with Article 61(3). Article 68 Decision to open group coordination proceedings 1. After the period referred to in Article 64(2) has elapsed, the court may open group coordination proceedings where it is satisfied that the conditions of Article 63(1) are met. In such a case, the court shall: (a) appoint a coordinator; (b) decide on the outline of the coordination; and (c) decide on the estimation of costs and the share to be paid by the group members. 2. The decision opening group coordination proceedings shall be brought to the notice of the participating insolvency practitioners and of the coordinator. Article 69 Subsequent opt-in by insolvency practitioners 1. In accordance with its national law, any insolvency practitioner may request, after the court decision referred to in Article 68, the inclusion of the proceedings in respect of which it has been appointed, where: (a) there has been an objection to the inclusion of the insolvency proceedings within the group coordination proceedings; or (b) insolvency proceedings with respect to a member of the group have been opened after the court has opened group coordination proceedings. 2. Without prejudice to paragraph 4, the coordinator may accede to such a request, after consulting the insolvency practitioners involved, where (a) he or she is satisfied that, taking into account the stage that the group coordination proceedings has reached at the time of the request, the criteria set out in points (a) and (b) of Article 63(1) are met; or (b) all insolvency practitioners involved agree, subject to the conditions in their national law. 3. The coordinator shall inform the court and the participating insolvency practitioners of his or her decision pursuant to paragraph 2 and of the reasons on which it is based. 4. Any participating insolvency practitioner or any insolvency practitioner whose request for inclusion in the group coordination proceedings has been rejected may challenge the decision referred to in paragraph 2 in accordance with the procedure set out under the law of the Member State in which the group coordination proceedings have been opened. Article 70 Recommendations and group coordination plan 1. When conducting their insolvency proceedings, insolvency practitioners shall consider the recommendations of the coordinator and the content of the group coordination plan referred to in Article 72(1). 2. An insolvency practitioner shall not be obliged to follow in whole or in part the coordinator's recommendations or the group coordination plan. If it does not follow the coordinator's recommendations or the group coordination plan, it shall give reasons for not doing so to the persons or bodies that it is to report to under its national law, and to the coordinator. Subsection 2 General provisions Article 71 The coordinator 1. The coordinator shall be a person eligible under the law of a Member State to act as an insolvency practitioner. 2. The coordinator shall not be one of the insolvency practitioners appointed to act in respect of any of the group members, and shall have no conflict of interest in respect of the group members, their creditors and the insolvency practitioners appointed in respect of any of the group members. Article 72 Tasks and rights of the coordinator 1. The coordinator shall: (a) identify and outline recommendations for the coordinated conduct of the insolvency proceedings; (b) propose a group coordination plan that identifies, describes and recommends a comprehensive set of measures appropriate to an integrated approach to the resolution of the group members' insolvencies. In particular, the plan may contain proposals for: (i) the measures to be taken in order to re-establish the economic performance and the financial soundness of the group or any part of it; (ii) the settlement of intra-group disputes as regards intra-group transactions and avoidance actions; (iii) agreements between the insolvency practitioners of the insolvent group members. 2. The coordinator may also: (a) be heard and participate, in particular by attending creditors' meetings, in any of the proceedings opened in respect of any member of the group; (b) mediate any dispute arising between two or more insolvency practitioners of group members; (c) present and explain his or her group coordination plan to the persons or bodies that he or she is to report to under his or her national law; (d) request information from any insolvency practitioner in respect of any member of the group where that information is or might be of use when identifying and outlining strategies and measures in order to coordinate the proceedings; and (e) request a stay for a period of up to 6 months of the proceedings opened in respect of any member of the group, provided that such a stay is necessary in order to ensure the proper implementation of the plan and would be to the benefit of the creditors in the proceedings for which the stay is requested; or request the lifting of any existing stay. Such a request shall be made to the court that opened the proceedings for which a stay is requested. 3. The plan referred to in point (b) of paragraph 1 shall not include recommendations as to any consolidation of proceedings or insolvency estates. 4. The coordinator's tasks and rights as defined under this Article shall not extend to any member of the group not participating in group coordination proceedings. 5. The coordinator shall perform his or her duties impartially and with due care. 6. Where the coordinator considers that the fulfilment of his or her tasks requires a significant increase in the costs compared to the cost estimate referred to in point (d) of Article 61(3), and in any case, where the costs exceed 10 % of the estimated costs, the coordinator shall: (a) inform without delay the participating insolvency practitioners; and (b) seek the prior approval of the court opening group coordination proceedings. Article 73 Languages 1. The coordinator shall communicate with the insolvency practitioner of a participating group member in the language agreed with the insolvency practitioner or, in the absence of an agreement, in the official language or one of the official languages of the institutions of the Union, and of the court which opened the proceedings in respect of that group member. 2. The coordinator shall communicate with a court in the official language applicable to that court. Article 74 Cooperation between insolvency practitioners and the coordinator 1. Insolvency practitioners appointed in relation to members of a group and the coordinator shall cooperate with each other to the extent that such cooperation is not incompatible with the rules applicable to the respective proceedings. 2. In particular, insolvency practitioners shall communicate any information that is relevant for the coordinator to perform his or her tasks. Article 75 Revocation of the appointment of the coordinator The court shall revoke the appointment of the coordinator of its own motion or at the request of the insolvency practitioner of a participating group member where: (a) the coordinator acts to the detriment of the creditors of a participating group member; or (b) the coordinator fails to comply with his or her obligations under this Chapter. Article 76 Debtor in possession The provisions applicable, under this Chapter, to the insolvency practitioner shall also apply, where appropriate, to the debtor in possession. Article 77 Costs and distribution 1. The remuneration for the coordinator shall be adequate, proportionate to the tasks fulfilled and reflect reasonable expenses. 2. On having completed his or her tasks, the coordinator shall establish the final statement of costs and the share to be paid by each member, and submit this statement to each participating insolvency practitioner and to the court opening coordination proceedings. 3. In the absence of objections by the insolvency practitioners within 30 days of receipt of the statement referred to in paragraph 2, the costs and the share to be paid by each member shall be deemed to be agreed. The statement shall be submitted to the court opening coordination proceedings for confirmation. 4. In the event of an objection, the court that opened the group coordination proceedings shall, upon the application of the coordinator or any participating insolvency practitioner, decide on the costs and the share to be paid by each member in accordance with the criteria set out in paragraph 1 of this Article, and taking into account the estimation of costs referred to in Article 68(1) and, where applicable, Article 72(6). 5. Any participating insolvency practitioner may challenge the decision referred to in paragraph 4 in accordance with the procedure set out under the law of the Member State where group coordination proceedings have been opened. CHAPTER VI DATA PROTECTION Article 78 Data protection 1. National rules implementing Directive 95/46/EC shall apply to the processing of personal data carried out in the Member States pursuant to this Regulation, provided that processing operations referred to in Article 3(2) of Directive 95/46/EC are not concerned. 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation. Article 79 Responsibilities of Member States regarding the processing of personal data in national insolvency registers 1. Each Member State shall communicate to the Commission the name of the natural or legal person, public authority, agency or any other body designated by national law to exercise the functions of controller in accordance with point (d) of Article 2 of Directive 95/46/EC, with a view to its publication on the European e-Justice Portal. 2. Member States shall ensure that the technical measures for ensuring the security of personal data processed in their national insolvency registers referred to in Article 24 are implemented. 3. Member States shall be responsible for verifying that the controller, designated by national law in accordance with point (d) of Article 2 of Directive 95/46/EC, ensures compliance with the principles of data quality, in particular the accuracy and the updating of data stored in national insolvency registers. 4. Member States shall be responsible, in accordance with Directive 95/46/EC, for the collection and storage of data in national databases and for decisions taken to make such data available in the interconnected register that can be consulted via the European e-Justice Portal. 5. As part of the information that should be provided to data subjects to enable them to exercise their rights, and in particular the right to the erasure of data, Member States shall inform data subjects of the accessibility period set for personal data stored in insolvency registers. Article 80 Responsibilities of the Commission in connection with the processing of personal data 1. The Commission shall exercise the responsibilities of controller pursuant to Article 2(d) of Regulation (EC) No 45/2001 in accordance with its respective responsibilities defined in this Article. 2. The Commission shall define the necessary policies and apply the necessary technical solutions to fulfil its responsibilities within the scope of the function of controller. 3. The Commission shall implement the technical measures required to ensure the security of personal data while in transit, in particular the confidentiality and integrity of any transmission to and from the European e-Justice Portal. 4. The obligations of the Commission shall not affect the responsibilities of the Member States and other bodies for the content and operation of the interconnected national databases run by them. Article 81 Information obligations Without prejudice to the information to be given to data subjects in accordance with Articles 11 and 12 of Regulation (EC) No 45/2001, the Commission shall inform data subjects, by means of publication through the European e-Justice Portal, about its role in the processing of data and the purposes for which those data will be processed. Article 82 Storage of personal data As regards information from interconnected national databases, no personal data relating to data subjects shall be stored in the European e-Justice Portal. All such data shall be stored in the national databases operated by the Member States or other bodies. Article 83 Access to personal data via the European e-Justice Portal Personal data stored in the national insolvency registers referred to in Article 24 shall be accessible via the European e-Justice Portal for as long as they remain accessible under national law. CHAPTER VII TRANSITIONAL AND FINAL PROVISIONS Article 84 Applicability in time 1. The provisions of this Regulation shall apply only to insolvency proceedings opened after 26 June 2017. Acts committed by a debtor before that date shall continue to be governed by the law which was applicable to them at the time they were committed. 2. Notwithstanding Article 91 of this Regulation, Regulation (EC) No 1346/2000 shall continue to apply to insolvency proceedings which fall within the scope of that Regulation and which have been opened before 26 June 2017. Article 85 Relationship to Conventions 1. This Regulation replaces, in respect of the matters referred to therein, and as regards relations between Member States, the Conventions concluded between two or more Member States, in particular: (a) the Convention between Belgium and France on Jurisdiction and the Validity and Enforcement of Judgments, Arbitration Awards and Authentic Instruments, signed at Paris on 8 July 1899; (b) the Convention between Belgium and Austria on Bankruptcy, Winding-up, Arrangements, Compositions and Suspension of Payments (with Additional Protocol of 13 June 1973), signed at Brussels on 16 July 1969; (c) the Convention between Belgium and the Netherlands on Territorial Jurisdiction, Bankruptcy and the Validity and Enforcement of Judgments, Arbitration Awards and Authentic Instruments, signed at Brussels on 28 March 1925; (d) the Treaty between Germany and Austria on Bankruptcy, Winding-up, Arrangements and Compositions, signed at Vienna on 25 May 1979; (e) the Convention between France and Austria on Jurisdiction, Recognition and Enforcement of Judgments on Bankruptcy, signed at Vienna on 27 February 1979; (f) the Convention between France and Italy on the Enforcement of Judgments in Civil and Commercial Matters, signed at Rome on 3 June 1930; (g) the Convention between Italy and Austria on Bankruptcy, Winding-up, Arrangements and Compositions, signed at Rome on 12 July 1977; (h) the Convention between the Kingdom of the Netherlands and the Federal Republic of Germany on the Mutual Recognition and Enforcement of Judgments and other Enforceable Instruments in Civil and Commercial Matters, signed at The Hague on 30 August 1962; (i) the Convention between the United Kingdom and the Kingdom of Belgium providing for the Reciprocal Enforcement of Judgments in Civil and Commercial Matters, with Protocol, signed at Brussels on 2 May 1934; (j) the Convention between Denmark, Finland, Norway, Sweden and Iceland on Bankruptcy, signed at Copenhagen on 7 November 1933; (k) the European Convention on Certain International Aspects of Bankruptcy, signed at Istanbul on 5 June 1990; (l) the Convention between the Federative People's Republic of Yugoslavia and the Kingdom of Greece on the Mutual Recognition and Enforcement of Judgments, signed at Athens on 18 June 1959; (m) the Agreement between the Federative People's Republic of Yugoslavia and the Republic of Austria on the Mutual Recognition and Enforcement of Arbitral Awards and Arbitral Settlements in Commercial Matters, signed at Belgrade on 18 March 1960; (n) the Convention between the Federative People's Republic of Yugoslavia and the Italian Republic on Mutual Judicial Cooperation in Civil and Administrative Matters, signed at Rome on 3 December 1960; (o) the Agreement between the Socialist Federative Republic of Yugoslavia and the Kingdom of Belgium on Judicial Cooperation in Civil and Commercial Matters, signed at Belgrade on 24 September 1971; (p) the Convention between the Governments of Yugoslavia and France on the Recognition and Enforcement of Judgments in Civil and Commercial Matters, signed at Paris on 18 May 1971; (q) the Agreement between the Czechoslovak Socialist Republic and the Hellenic Republic on Legal Aid in Civil and Criminal Matters, signed at Athens on 22 October 1980, still in force between the Czech Republic and Greece; (r) the Agreement between the Czechoslovak Socialist Republic and the Republic of Cyprus on Legal Aid in Civil and Criminal Matters, signed at Nicosia on 23 April 1982, still in force between the Czech Republic and Cyprus; (s) the Treaty between the Government of the Czechoslovak Socialist Republic and the Government of the Republic of France on Legal Aid and the Recognition and Enforcement of Judgments in Civil, Family and Commercial Matters, signed at Paris on 10 May 1984, still in force between the Czech Republic and France; (t) the Treaty between the Czechoslovak Socialist Republic and the Italian Republic on Legal Aid in Civil and Criminal Matters, signed at Prague on 6 December 1985, still in force between the Czech Republic and Italy; (u) the Agreement between the Republic of Latvia, the Republic of Estonia and the Republic of Lithuania on Legal Assistance and Legal Relationships, signed at Tallinn on 11 November 1992; (v) the Agreement between Estonia and Poland on Granting Legal Aid and Legal Relations on Civil, Labour and Criminal Matters, signed at Tallinn on 27 November 1998; (w) the Agreement between the Republic of Lithuania and the Republic of Poland on Legal Assistance and Legal Relations in Civil, Family, Labour and Criminal Matters, signed at Warsaw on 26 January 1993; (x) the Convention between the Socialist Republic of Romania and the Hellenic Republic on legal assistance in civil and criminal matters and its Protocol, signed at Bucharest on 19 October 1972; (y) the Convention between the Socialist Republic of Romania and the French Republic on legal assistance in civil and commercial matters, signed at Paris on 5 November 1974; (z) the Agreement between the People's Republic of Bulgaria and the Hellenic Republic on Legal Assistance in Civil and Criminal Matters, signed at Athens on 10 April 1976; (aa) the Agreement between the People's Republic of Bulgaria and the Republic of Cyprus on Legal Assistance in Civil and Criminal Matters, signed at Nicosia on 29 April 1983; (ab) the Agreement between the Government of the People's Republic of Bulgaria and the Government of the French Republic on Mutual Legal Assistance in Civil Matters, signed at Sofia on 18 January 1989; (ac) the Treaty between Romania and the Czech Republic on judicial assistance in civil matters, signed at Bucharest on 11 July 1994; (ad) the Treaty between Romania and the Republic of Poland on legal assistance and legal relations in civil cases, signed at Bucharest on 15 May 1999. 2. The Conventions referred to in paragraph 1 shall continue to have effect with regard to proceedings opened before the entry into force of Regulation (EC) No 1346/2000. 3. This Regulation shall not apply: (a) in any Member State, to the extent that it is irreconcilable with the obligations arising in relation to bankruptcy from a convention concluded by that Member State with one or more third countries before the entry into force of Regulation (EC) No 1346/2000; (b) in the United Kingdom of Great Britain and Northern Ireland, to the extent that is irreconcilable with the obligations arising in relation to bankruptcy and the winding-up of insolvent companies from any arrangements with the Commonwealth existing at the time Regulation (EC) No 1346/2000 entered into force. Article 86 Information on national and Union insolvency law 1. The Member States shall provide, within the framework of the European Judicial Network in civil and commercial matters established by Council Decision 2001/470/EC (17), and with a view to making the information available to the public, a short description of their national legislation and procedures relating to insolvency, in particular relating to the matters listed in Article 7(2). 2. The Member States shall update the information referred to in paragraph 1 regularly. 3. The Commission shall make information concerning this Regulation available to the public. Article 87 Establishment of the interconnection of registers The Commission shall adopt implementing acts establishing the interconnection of insolvency registers as referred to in Article 25. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 89(3). Article 88 Establishment and subsequent amendment of standard forms The Commission shall adopt implementing acts establishing and, where necessary, amending the forms referred to in Article 27(4), Articles 54 and 55 and Article 64(2). Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 89(2). Article 89 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 90 Review clause 1. No later than 27 June 2027, and every 5 years thereafter, the Commission shall present to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Regulation. The report shall be accompanied where necessary by a proposal for adaptation of this Regulation. 2. No later than 27 June 2022, the Commission shall present to the European Parliament, the Council and the European Economic and Social Committee a report on the application of the group coordination proceedings. The report shall be accompanied where necessary by a proposal for adaptation of this Regulation. 3. No later than 1 January 2016, the Commission shall submit to the European Parliament, the Council and the European Economic and Social Committee a study on the cross-border issues in the area of directors' liability and disqualifications. 4. No later than 27 June 2020, the Commission shall submit to the European Parliament, the Council and the European Economic and Social Committee a study on the issue of abusive forum shopping. Article 91 Repeal Regulation (EC) No 1346/2000 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex D to this Regulation. Article 92 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 June 2017, with the exception of: (a) Article 86, which shall apply from 26 June 2016; (b) Article 24(1), which shall apply from 26 June 2018; and (c) Article 25, which shall apply from 26 June 2019. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 20 May 2015. For the European Parliament The President M. SCHULZ For the Council The President Z. KALNI\u0145A-LUKA\u0160EVICA (1) OJ C 271, 19.9.2013, p. 55. (2) Position of the European Parliament of 5 February 2014 (not yet published in the Official Journal) and position of the Council at first reading of 12 March 2015 (not yet published in the Official Journal). Position of the European Parliament of 20 May 2015 (not yet published in the Official Journal). (3) Council Regulation (EC) No 1346/2000 of 29 May 2000 on insolvency proceedings (OJ L 160, 30.6.2000, p. 1). (4) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (5) Directive 2001/24/EC of the European Parliament and of the Council of 4 April 2001 on the reorganisation and winding-up of credit institutions (OJ L 125, 5.5.2001, p. 15). (6) Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil and commercial matters (service of documents), and repealing Council Regulation (EC) No 1348/2000 (OJ L 324, 10.12.2007, p. 79). (7) Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (OJ L 166, 11.6.1998, p. 45). (8) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (9) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (10) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (11) Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits (OJ L 124, 8.6.1971, p. 1). (12) OJ C 358, 7.12.2013, p. 15. (13) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32). (14) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1). (15) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertaking, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19). (16) Directive 2008/94/EC of the European Parliament and of the Council of 22 October 2008 on the protection of employees in the event of the insolvency of their employer (OJ L 283, 28.10.2008, p. 36). (17) Council Decision 2001/470/EC of 28 May 2001 establishing a European Judicial Network in civil and commercial matters (OJ L 174, 27.6.2001, p. 25). ANNEX A Insolvency proceedings referred to in point (4) of Article 2 BELGIQUE/BELGI\u00cb \u2014 Het faillissement/La faillite, \u2014 De gerechtelijke reorganisatie door een collectief akkoord/La r\u00e9organisation judiciaire par accord collectif, \u2014 De gerechtelijke reorganisatie door een minnelijk akkoord/La r\u00e9organisation judiciaire par accord amiable, \u2014 De gerechtelijke reorganisatie door overdracht onder gerechtelijk gezag/La r\u00e9organisation judiciaire par transfert sous autorit\u00e9 de justice, \u2014 De collectieve schuldenregeling/Le r\u00e8glement collectif de dettes, \u2014 De vrijwillige vereffening/La liquidation volontaire, \u2014 De gerechtelijke vereffening/La liquidation judiciaire, \u2014 De voorlopige ontneming van beheer, bepaald in artikel 8 van de faillissementswet/Le dessaisissement provisoire, vis\u00e9 \u00e0 l'article 8 de la loi sur les faillites, \u0411\u042a\u041b\u0413\u0410\u0420\u0418\u042f \u2014 \u041f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u043e \u043f\u043e \u043d\u0435\u0441\u044a\u0441\u0442\u043e\u044f\u0442\u0435\u043b\u043d\u043e\u0441\u0442, \u010cESK\u00c1 REPUBLIKA \u2014 Konkurs, \u2014 Reorganizace, \u2014 Oddlu\u017een\u00ed, DEUTSCHLAND \u2014 Das Konkursverfahren, \u2014 Das gerichtliche Vergleichsverfahren, \u2014 Das Gesamtvollstreckungsverfahren, \u2014 Das Insolvenzverfahren, EESTI \u2014 Pankrotimenetlus, \u2014 V\u00f5lgade \u00fcmberkujundamise menetlus, \u00c9IRE/IRELAND \u2014 Compulsory winding-up by the court, \u2014 Bankruptcy, \u2014 The administration in bankruptcy of the estate of persons dying insolvent, \u2014 Winding-up in bankruptcy of partnerships, \u2014 Creditors' voluntary winding-up (with confirmation of a court), \u2014 Arrangements under the control of the court which involve the vesting of all or part of the property of the debtor in the Official Assignee for realisation and distribution, \u2014 Examinership, \u2014 Debt Relief Notice, \u2014 Debt Settlement Arrangement, \u2014 Personal Insolvency Arrangement, \u0395\u039b\u039b\u0391\u0394\u0391 \u2014 \u0397 \u03c0\u03c4\u03ce\u03c7\u03b5\u03c5\u03c3\u03b7, \u2014 \u0397 \u03b5\u03b9\u03b4\u03b9\u03ba\u03ae \u03b5\u03ba\u03ba\u03b1\u03b8\u03ac\u03c1\u03b9\u03c3\u03b7 \u03b5\u03bd \u03bb\u03b5\u03b9\u03c4\u03bf\u03c5\u03c1\u03b3\u03af\u03b1, \u2014 \u03a3\u03c7\u03ad\u03b4\u03b9\u03bf \u03b1\u03bd\u03b1\u03b4\u03b9\u03bf\u03c1\u03b3\u03ac\u03bd\u03c9\u03c3\u03b7\u03c2, \u2014 \u0391\u03c0\u03bb\u03bf\u03c0\u03bf\u03b9\u03b7\u03bc\u03ad\u03bd\u03b7 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b1 \u03b5\u03c0\u03af \u03c0\u03c4\u03c9\u03c7\u03b5\u03cd\u03c3\u03b5\u03c9\u03bd \u03bc\u03b9\u03ba\u03c1\u03bf\u03cd \u03b1\u03bd\u03c4\u03b9\u03ba\u03b5\u03b9\u03bc\u03ad\u03bd\u03bf\u03c5, \u2014 \u0394\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b1 \u0395\u03be\u03c5\u03b3\u03af\u03b1\u03bd\u03c3\u03b7\u03c2, ESPA\u00d1A \u2014 Concurso, \u2014 Procedimiento de homologaci\u00f3n de acuerdos de refinanciaci\u00f3n, \u2014 Procedimiento de acuerdos extrajudiciales de pago, \u2014 Procedimiento de negociaci\u00f3n p\u00fablica para la consecuci\u00f3n de acuerdos de refinanciaci\u00f3n colectivos, acuerdos de refinanciaci\u00f3n homologados y propuestas anticipadas de convenio, FRANCE \u2014 Sauvegarde, \u2014 Sauvegarde acc\u00e9l\u00e9r\u00e9e, \u2014 Sauvegarde financi\u00e8re acc\u00e9l\u00e9r\u00e9e, \u2014 Redressement judiciaire, \u2014 Liquidation judiciaire, HRVATSKA \u2014 Ste\u010dajni postupak, ITALIA \u2014 Fallimento, \u2014 Concordato preventivo, \u2014 Liquidazione coatta amministrativa, \u2014 Amministrazione straordinaria, \u2014 Accordi di ristrutturazione, \u2014 Procedure di composizione della crisi da sovraindebitamento del consumatore (accordo o piano), \u2014 Liquidazione dei beni, \u039a\u03a5\u03a0\u03a1\u039f\u03a3 \u2014 \u03a5\u03c0\u03bf\u03c7\u03c1\u03b5\u03c9\u03c4\u03b9\u03ba\u03ae \u03b5\u03ba\u03ba\u03b1\u03b8\u03ac\u03c1\u03b9\u03c3\u03b7 \u03b1\u03c0\u03cc \u03c4\u03bf \u0394\u03b9\u03ba\u03b1\u03c3\u03c4\u03ae\u03c1\u03b9\u03bf, \u2014 \u0395\u03ba\u03bf\u03cd\u03c3\u03b9\u03b1 \u03b5\u03ba\u03ba\u03b1\u03b8\u03ac\u03c1\u03b9\u03c3\u03b7 \u03b1\u03c0\u03cc \u03bc\u03ad\u03bb\u03b7, \u2014 \u0395\u03ba\u03bf\u03cd\u03c3\u03b9\u03b1 \u03b5\u03ba\u03ba\u03b1\u03b8\u03ac\u03c1\u03b9\u03c3\u03b7 \u03b1\u03c0\u03cc \u03c0\u03b9\u03c3\u03c4\u03c9\u03c4\u03ad\u03c2 \u2014 \u0395\u03ba\u03ba\u03b1\u03b8\u03ac\u03c1\u03b9\u03c3\u03b7 \u03bc\u03b5 \u03c4\u03b7\u03bd \u03b5\u03c0\u03bf\u03c0\u03c4\u03b5\u03af\u03b1 \u03c4\u03bf\u03c5 \u0394\u03b9\u03ba\u03b1\u03c3\u03c4\u03b7\u03c1\u03af\u03bf\u03c5, \u2014 \u0394\u03b9\u03ac\u03c4\u03b1\u03b3\u03bc\u03b1 \u03a0\u03b1\u03c1\u03b1\u03bb\u03b1\u03b2\u03ae\u03c2 \u03ba\u03b1\u03b9 \u03c0\u03c4\u03ce\u03c7\u03b5\u03c5\u03c3\u03b7\u03c2 \u03ba\u03b1\u03c4\u03cc\u03c0\u03b9\u03bd \u0394\u03b9\u03ba\u03b1\u03c3\u03c4\u03b9\u03ba\u03bf\u03cd \u0394\u03b9\u03b1\u03c4\u03ac\u03b3\u03bc\u03b1\u03c4\u03bf\u03c2, \u2014 \u0394\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03c0\u03b5\u03c1\u03b9\u03bf\u03c5\u03c3\u03af\u03b1\u03c2 \u03c0\u03c1\u03bf\u03c3\u03ce\u03c0\u03c9\u03bd \u03c0\u03bf\u03c5 \u03b1\u03c0\u03b5\u03b2\u03af\u03c9\u03c3\u03b1\u03bd \u03b1\u03c6\u03b5\u03c1\u03ad\u03b3\u03b3\u03c5\u03b1, LATVIJA \u2014 Tiesisk\u0101s aizsardz\u012bbas process, \u2014 Juridisk\u0101s personas maks\u0101tnesp\u0113jas process, \u2014 Fizisk\u0101s personas maks\u0101tnesp\u0113jas process, LIETUVA \u2014 \u012emon\u0117s restrukt\u016brizavimo byla, \u2014 \u012emon\u0117s bankroto byla, \u2014 \u012emon\u0117s bankroto procesas ne teismo tvarka, \u2014 Fizinio asmens bankroto procesas, LUXEMBOURG \u2014 Faillite, \u2014 Gestion contr\u00f4l\u00e9e, \u2014 Concordat pr\u00e9ventif de faillite (par abandon d'actif), \u2014 R\u00e9gime sp\u00e9cial de liquidation du notariat, \u2014 Proc\u00e9dure de r\u00e8glement collectif des dettes dans le cadre du surendettement, MAGYARORSZ\u00c1G \u2014 Cs\u0151delj\u00e1r\u00e1s, \u2014 Felsz\u00e1mol\u00e1si elj\u00e1r\u00e1s, MALTA \u2014 Xoljiment, \u2014 Amministrazzjoni, \u2014 Stral\u010b volontarju mill-membri jew mill-kredituri, \u2014 Stral\u010b mill-Qorti, \u2014 Falliment f'ka\u017c ta' kummer\u010bjant, \u2014 Pro\u010bedura biex kumpanija tirkupra, NEDERLAND \u2014 Het faillissement, \u2014 De surs\u00e9ance van betaling, \u2014 De schuldsaneringsregeling natuurlijke personen, \u00d6STERREICH \u2014 Das Konkursverfahren (Insolvenzverfahren), \u2014 Das Sanierungsverfahren ohne Eigenverwaltung (Insolvenzverfahren), \u2014 Das Sanierungsverfahren mit Eigenverwaltung (Insolvenzverfahren), \u2014 Das Schuldenregulierungsverfahren, \u2014 Das Absch\u00f6pfungsverfahren, \u2014 Das Ausgleichsverfahren, POLSKA \u2014 Post\u0119powanie naprawcze, \u2014 Upad\u0142o\u015b\u0107 obejmuj\u0105ca likwidacj\u0119, \u2014 Upad\u0142o\u015b\u0107 z mo\u017cliwo\u015bci\u0105 zawarcia uk\u0142adu, PORTUGAL \u2014 Processo de insolv\u00eancia, \u2014 Processo especial de revitaliza\u00e7\u00e3o, ROM\u00c2NIA \u2014 Procedura insolven\u021bei, \u2014 Reorganizarea judiciar\u0103, \u2014 Procedura falimentului, \u2014 Concordatul preventiv, SLOVENIJA \u2014 Postopek preventivnega prestrukturiranja, \u2014 Postopek prisilne poravnave, \u2014 Postopek poenostavljene prisilne poravnave, \u2014 Ste\u010dajni postopek: ste\u010dajni postopek nad pravno osebo, postopek osebnega ste\u010daja and postopek ste\u010daja zapu\u0161\u010dine, SLOVENSKO \u2014 Konkurzn\u00e9 konanie, \u2014 Re\u0161trukturaliza\u010dn\u00e9 konanie, \u2014 Oddl\u017eenie, SUOMI/FINLAND \u2014 Konkurssi/konkurs, \u2014 Yrityssaneeraus/f\u00f6retagssanering, \u2014 Yksityishenkil\u00f6n velkaj\u00e4rjestely/skuldsanering f\u00f6r privatpersoner, SVERIGE \u2014 Konkurs, \u2014 F\u00f6retagsrekonstruktion, \u2014 Skuldsanering, UNITED KINGDOM \u2014 Winding-up by or subject to the supervision of the court, \u2014 Creditors' voluntary winding-up (with confirmation by the court), \u2014 Administration, including appointments made by filing prescribed documents with the court, \u2014 Voluntary arrangements under insolvency legislation, \u2014 Bankruptcy or sequestration. ANNEX B Insolvency practitioners referred to in point (5) of Article 2 BELGIQUE/BELGI\u00cb \u2014 De curator/Le curateur, \u2014 De gedelegeerd rechter/Le juge-d\u00e9l\u00e9gu\u00e9, \u2014 De gerechtsmandataris/Le mandataire de justice, \u2014 De schuldbemiddelaar/Le m\u00e9diateur de dettes, \u2014 De vereffenaar/Le liquidateur, \u2014 De voorlopige bewindvoerder/L'administrateur provisoire, \u0411\u042a\u041b\u0413\u0410\u0420\u0418\u042f \u2014 \u041d\u0430\u0437\u043d\u0430\u0447\u0435\u043d \u043f\u0440\u0435\u0434\u0432\u0430\u0440\u0438\u0442\u0435\u043b\u043d\u043e \u0432\u0440\u0435\u043c\u0435\u043d\u0435\u043d \u0441\u0438\u043d\u0434\u0438\u043a, \u2014 \u0412\u0440\u0435\u043c\u0435\u043d\u0435\u043d \u0441\u0438\u043d\u0434\u0438\u043a, \u2014 (\u041f\u043e\u0441\u0442\u043e\u044f\u043d\u0435\u043d) \u0441\u0438\u043d\u0434\u0438\u043a, \u2014 \u0421\u043b\u0443\u0436\u0435\u0431\u0435\u043d \u0441\u0438\u043d\u0434\u0438\u043a, \u010cESK\u00c1 REPUBLIKA \u2014 Insolven\u010dn\u00ed spr\u00e1vce, \u2014 P\u0159edb\u011b\u017en\u00fd insolven\u010dn\u00ed spr\u00e1vce, \u2014 Odd\u011blen\u00fd insolven\u010dn\u00ed spr\u00e1vce, \u2014 Zvl\u00e1\u0161tn\u00ed insolven\u010dn\u00ed spr\u00e1vce, \u2014 Z\u00e1stupce insolven\u010dn\u00edho spr\u00e1vce, DEUTSCHLAND \u2014 Konkursverwalter, \u2014 Vergleichsverwalter, \u2014 Sachwalter (nach der Vergleichsordnung), \u2014 Verwalter, \u2014 Insolvenzverwalter, \u2014 Sachwalter (nach der Insolvenzordnung), \u2014 Treuh\u00e4nder, \u2014 Vorl\u00e4ufiger Insolvenzverwalter, \u2014 Vorl\u00e4ufiger Sachwalter, EESTI \u2014 Pankrotihaldur, \u2014 Ajutine pankrotihaldur, \u2014 Usaldusisik, \u00c9IRE/IRELAND \u2014 Liquidator, \u2014 Official Assignee, \u2014 Trustee in bankruptcy, \u2014 Provisional Liquidator, \u2014 Examiner, \u2014 Personal Insolvency Practitioner, \u2014 Insolvency Service, \u0395\u039b\u039b\u0391\u0394\u0391 \u2014 \u039f \u03c3\u03cd\u03bd\u03b4\u03b9\u03ba\u03bf\u03c2, \u2014 \u039f \u03b5\u03b9\u03c3\u03b7\u03b3\u03b7\u03c4\u03ae\u03c2, \u2014 \u0397 \u03b5\u03c0\u03b9\u03c4\u03c1\u03bf\u03c0\u03ae \u03c4\u03c9\u03bd \u03c0\u03b9\u03c3\u03c4\u03c9\u03c4\u03ce\u03bd, \u2014 \u039f \u03b5\u03b9\u03b4\u03b9\u03ba\u03cc\u03c2 \u03b5\u03ba\u03ba\u03b1\u03b8\u03b1\u03c1\u03b9\u03c3\u03c4\u03ae\u03c2, ESPA\u00d1A \u2014 Administrador concursal, \u2014 Mediador concursal, FRANCE \u2014 Mandataire judiciaire, \u2014 Liquidateur, \u2014 Administrateur judiciaire, \u2014 Commissaire \u00e0 l'ex\u00e9cution du plan, HRVATSKA \u2014 Ste\u010dajni upravitelj, \u2014 Privremeni ste\u010dajni upravitelj, \u2014 Ste\u010dajni povjerenik, \u2014 Povjerenik, ITALIA \u2014 Curatore, \u2014 Commissario giudiziale, \u2014 Commissario straordinario, \u2014 Commissario liquidatore, \u2014 Liquidatore giudiziale, \u2014 Professionista nominato dal Tribunale, \u2014 Organismo di composizione della crisi nella procedura di composizione della crisi da sovraindebitamento del consumatore, \u2014 Liquidatore, \u039a\u03a5\u03a0\u03a1\u039f\u03a3 \u2014 \u0395\u03ba\u03ba\u03b1\u03b8\u03b1\u03c1\u03b9\u03c3\u03c4\u03ae\u03c2 \u03ba\u03b1\u03b9 \u03a0\u03c1\u03bf\u03c3\u03c9\u03c1\u03b9\u03bd\u03cc\u03c2 \u0395\u03ba\u03ba\u03b1\u03b8\u03b1\u03c1\u03b9\u03c3\u03c4\u03ae\u03c2, \u2014 \u0395\u03c0\u03af\u03c3\u03b7\u03bc\u03bf\u03c2 \u03a0\u03b1\u03c1\u03b1\u03bb\u03ae\u03c0\u03c4\u03b7\u03c2, \u2014 \u0394\u03b9\u03b1\u03c7\u03b5\u03b9\u03c1\u03b9\u03c3\u03c4\u03ae\u03c2 \u03c4\u03b7\u03c2 \u03a0\u03c4\u03ce\u03c7\u03b5\u03c5\u03c3\u03b7\u03c2, LATVIJA \u2014 Maks\u0101tnesp\u0113jas procesa administrators, LIETUVA \u2014 Bankroto administratorius, \u2014 Restrukt\u016brizavimo administratorius, LUXEMBOURG \u2014 Le curateur, \u2014 Le commissaire, \u2014 Le liquidateur, \u2014 Le conseil de g\u00e9rance de la section d'assainissement du notariat, \u2014 Le liquidateur dans le cadre du surendettement, MAGYARORSZ\u00c1G \u2014 Vagyonfel\u00fcgyel\u0151, \u2014 Felsz\u00e1mol\u00f3, MALTA \u2014 Amministratur Provi\u017corju, \u2014 Ri\u010bevitur Uffi\u010bjali, \u2014 Stral\u010bjarju, \u2014 Manager Spe\u010bjali, \u2014 Kuraturi f'ka\u017c ta' pro\u010beduri ta' falliment, \u2014 Kontrolur Spe\u010bjali, NEDERLAND \u2014 De curator in het faillissement, \u2014 De bewindvoerder in de surs\u00e9ance van betaling, \u2014 De bewindvoerder in de schuldsaneringsregeling natuurlijke personen, \u00d6STERREICH \u2014 Masseverwalter, \u2014 Sanierungsverwalter, \u2014 Ausgleichsverwalter, \u2014 Besonderer Verwalter, \u2014 Einstweiliger Verwalter, \u2014 Sachwalter, \u2014 Treuh\u00e4nder, \u2014 Insolvenzgericht, \u2014 Konkursgericht, POLSKA \u2014 Syndyk, \u2014 Nadzorca s\u0105dowy, \u2014 Zarz\u0105dca, PORTUGAL \u2014 Administrador da insolv\u00eancia, \u2014 Administrador judicial provis\u00f3rio, ROM\u00c2NIA \u2014 Practician \u00een insolven\u021b\u0103, \u2014 Administrator concordatar, \u2014 Administrator judiciar, \u2014 Lichidator judiciar, SLOVENIJA \u2014 Upravitelj, SLOVENSKO \u2014 Predbe\u017en\u00fd spr\u00e1vca, \u2014 Spr\u00e1vca, SUOMI/FINLAND \u2014 Pes\u00e4nhoitaja/bof\u00f6rvaltare, \u2014 Selvitt\u00e4j\u00e4/utredare, SVERIGE \u2014 F\u00f6rvaltare, \u2014 Rekonstrukt\u00f6r, UNITED KINGDOM \u2014 Liquidator, \u2014 Supervisor of a voluntary arrangement, \u2014 Administrator, \u2014 Official Receiver, \u2014 Trustee, \u2014 Provisional Liquidator, \u2014 Interim Receiver, \u2014 Judicial factor. ANNEX C Repealed Regulation with list of the successive amendments thereto Council Regulation (EC) No 1346/2000 (OJ L 160, 30.6.2000, p. 1) Council Regulation (EC) No 603/2005 (OJ L 100, 20.4.2005, p. 1) Council Regulation (EC) No 694/2006 (OJ L 121, 6.5.2006, p. 1) Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1) Council Regulation (EC) No 681/2007 (OJ L 159, 20.6.2007, p. 1) Council Regulation (EC) No 788/2008 (OJ L 213, 8.8.2008, p. 1) Implementing Regulation of the Council (EU) No 210/2010 (OJ L 65, 13.3.2010, p. 1) Council Implementing Regulation (EU) No 583/2011 (OJ L 160, 18.6.2011, p. 52) Council Regulation (EU) No 517/2013 (OJ L 158, 10.6.2013, p. 1) Council Implementing Regulation (EU) No 663/2014 (OJ L 179, 19.6.2014, p. 4) Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (OJ L 236, 23.9.2003, p. 33) ANNEX D Correlation table Regulation (EC) No 1346/2000 This Regulation Article 1 Article 1 Article 2, introductory words Article 2, introductory words Article 2, point (a) Article 2, point (4) Article 2, point (b) Article 2, point (5) Article 2, point (c) \u2014 Article 2, point (d) Article 2, point (6) Article 2, point (e) Article 2, point (7) Article 2, point (f) Article 2, point (8) Article 2, point (g), introductory words Article 2, point (9), introductory words Article 2, point (g), first indent Article 2, point (9)(vii) Article 2, point (g), second indent Article 2, point (9)(iv) Article 2, point (g), third indent Article 2, point (9)(viii) Article 2, point (h) Article 2, point 10 \u2014 Article 2, points (1) to (3) and (11) to (13) \u2014 Article 2, point (9)(i) to (iii), (v), (vi) Article 3 Article 3 \u2014 Article 4 \u2014 Article 5 \u2014 Article 6 Article 4 Article 7 Article 5 Article 8 Article 6 Article 9 Article 7 Article 10 Article 8 Article 11(1) \u2014 Article 11(2) Article 9 Article 12 Article 10 Article 13(1) \u2014 Article 13(2) Article 11 Article 14 Article 12 Article 15 Article 13, first indent Article 16, point (a) Article 13, second indent Article 16, point (b) Article 14, first indent Article 17, point (a) Article 14, second indent Article 17, point (b) Article 14, third indent Article 17, point (c) Article 15 Article 18 Article 16 Article 19 Article 17 Article 20 Article 18 Article 21 Article 19 Article 22 Article 20 Article 23 \u2014 Article 24 \u2014 Article 25 \u2014 Article 26 \u2014 Article 27 Article 21(1) Article 28(2) Article 21(2) Article 28(1) Article 22 Article 29 Article 23 Article 30 Article 24 Article 31 Article 25 Article 32 Article 26 Article 33 Article 27 Article 34 Article 28 Article 35 \u2014 Article 36 Article 29 Article 37(1) \u2014 Article 37(2) \u2014 Article 38 \u2014 Article 39 Article 30 Article 40 Article 31 Article 41 \u2014 Article 42 \u2014 Article 43 \u2014 Article 44 Article 32 Article 45 Article 33 Article 46 Article 34(1) Article 47(1) Article 34(2) Article 47(2) Article 34(3) \u2014 \u2014 Article 48 Article 35 Article 49 Article 36 Article 50 Article 37 Article 51 Article 38 Article 52 Article 39 Article 53 Article 40 Article 54 Article 41 Article 55 Article 42 \u2014 \u2014 Article 56 \u2014 Article 57 \u2014 Article 58 \u2014 Article 59 \u2014 Article 60 \u2014 Article 61 \u2014 Article 62 \u2014 Article 63 \u2014 Article 64 \u2014 Article 65 \u2014 Article 66 \u2014 Article 67 \u2014 Article 68 \u2014 Article 69 \u2014 Article 70 \u2014 Article 71 \u2014 Article 72 \u2014 Article 73 \u2014 Article 74 \u2014 Article 75 \u2014 Article 76 \u2014 Article 77 \u2014 Article 78 \u2014 Article 79 \u2014 Article 80 \u2014 Article 81 \u2014 Article 82 \u2014 Article 83 Article 43 Article 84(1) \u2014 Article 84(2) Article 44 Article 85 \u2014 Article 86 Article 45 \u2014 \u2014 Article 87 \u2014 Article 88 \u2014 Article 89 Article 46 Article 90(1) \u2014 Article 90(2) to (4) \u2014 Article 91 Article 47 Article 92 Annex A Annex A Annex B \u2014 Annex C Annex B \u2014 Annex C \u2014 Annex D", "summary": "More effective rules on insolvency proceedings across EU borders More effective rules on insolvency proceedings across EU borders SUMMARY OF: Regulation (EU) 2015/848 \u2014 insolvency proceedings WHAT IS THE AIM OF THE REGULATION? It aims to ensure the efficient administration of insolvency proceedings involving an individual or business with business activities or financial interests in an European Union (EU) country other than the one in which they are usually based. It recasts and replaces Regulation (EC) No 1346/2000. KEY POINTS The regulation sets out EU-wide rules to establish:which court has jurisdiction to open an insolvency case;the applicable national law;recognition of the court\u2019s decision when a company, a trader or an individual becomes insolvent. It does not apply to Denmark. Applicable situations The regulation applies to proceedings which include all or a significant part of a debtor\u2019s creditors, are based on insolvency laws and in which, for the purpose of rescue, adjustment of debt, reorganisation or liquidation: 1.a debtor has lost all or part of its assets and an insolvency specialist, such as a liquidator, has been appointed; 2.the assets and affairs of a debtor are under the control or supervision of a court; or 3.proceedings have been halted to allow for negotiations between the debtor and its creditors. This situation is only applicable if it takes place in the context of proceedings which aim at protecting the general body of creditors;the negotiations fail, in which case one of the 2 other types of proceedings listed above would follow. The regulation covers \u2018preventive\u2019 insolvency proceedings available under national law which may be launched at an early stage in order to improve the chances of rescuing the business. These proceedings are listed in Annex A. It also covers a larger range of personal insolvency proceedings. Jurisdiction Proceedings take place in the courts of the EU country where the debtor\u2019s main interests are centred. This is presumed to mean: the location of the registered office, in the case of a company or legal person;the principal place of business, in the case of an individual running a business or professional activity;where they usually live, in the case of any other individual. These presumptions do not apply if the location has changed within a certain period prior to the start of insolvency proceedings. If the debtor has a place of operation in an EU country other than the one where the debtor's main interests are centred, that EU country may also open insolvency proceedings against the debtor. However, these \u2018secondary proceedings\u2019 are limited to the assets held in that country. The regulation improves the chances that companies will be rescued by avoiding the opening of parallel secondary proceedings, where interests of local creditors are otherwise guaranteed. Applicable law In general, the applicable law is that of the country in which the proceedings take place. That law governs the conditions for opening and closing the proceedings and their conduct. This includes determining: the debtors against whom a case can be brought; the assets which form part of the insolvency estate; creditors\u2019 rights after the case is closed; who bears the costs and expenses of the proceedings. Recognition and enforcement Once a judgment opening insolvency proceedings in one EU country becomes effective, it must be recognised in all other EU countries with the same effect. Insolvency registers To better ensure creditors and courts receive relevant information and to prevent parallel proceedings being opened, EU countries are required to publish relevant information on cross-border insolvency cases in a publicly accessible online register. These registers will be interconnected via the European e-Justice portal, in line with EU data protection rules. Group insolvency proceedings The regulation creates a specific approach to deal with the insolvency of members of a group of companies. This includes: rules requiring the various insolvency practitioners and the courts involved to cooperate and communicate with each other; limited rights of standing for an insolvency practitioner in the proceedings concerning another member of the same group; a specific system for the coordination of proceedings concerning the same company group (\u2018group coordination proceedings\u2019). Amendments to the Annexes The regulation has been amended twice: Regulation (EU) 2017/353 replaced Annex A (list of insolvency procedures) and Annex B (list of insolvency practitioners) to Regulation (EU) 2015/848 with new lists taking account of information provided by Poland. Regulation (EU) 2018/946 replaces Annexes A and B following notifications of changes received from Belgium, Bulgaria, Croatia, Latvia and Portugal. FROM WHEN DOES THE REGULATION APPLY? It has applied since 26 June 2017. Regulation (EU) 2015/848 revised and replaced Regulation (EC) No 1346/2000 (and its subsequent amendments). BACKGROUND For more information, see: Insolvency proceedings (European Commission). MAIN DOCUMENT Regulation (EU) 2015/848 of the European Parliament and of the Council of 20 May 2015 on insolvency proceedings (recast) (OJ L 141, 5.6.2015, pp. 19-72) Successive amendments to Regulation (EU) 2015/848 have been incorporated into the basic text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) 2017/1105 of 12 June 2017 establishing the forms referred to in Regulation (EU) 2015/848 of the European Parliament and of the Council on insolvency proceedings (OJ L 160, 22.6.2017, pp. 1-26) last update 08.04.2019"}
{"article": "28.5.2009 EN Official Journal of the European Union L 131/24 REGULATION (EC) No 392/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2009 on the liability of carriers of passengers by sea in the event of accidents (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 3 February 2009, Whereas: (1) Within the framework of the common transport policy, further measures need to be adopted in order to enhance safety in maritime transport. Those measures should include liability rules for damage caused to passengers, since it is important to ensure a proper level of compensation for passengers involved in maritime accidents. (2) The Protocol of 2002 to the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 1974 was adopted on 1 November 2002 under the auspices of the International Maritime Organisation (IMO). The Community and its Member States are in the process of deciding whether to accede to or ratify that Protocol. In any case, the provisions thereof incorporated by this Regulation should apply for the Community from no later than 31 December 2012. (3) The Athens Convention relating to the Carriage of Passengers and their Luggage by Sea 1974, as amended by the Protocol of 2002 (the Athens Convention), applies to international transport only. The distinction between national and international transport has been eliminated within the internal market in maritime transport services and it is therefore appropriate to have the same level and nature of liability in both international and national transport within the Community. (4) The insurance arrangements required under the Athens Convention must take into consideration the financial means of ship-owners and insurance companies. Ship-owners must be in a position to manage their insurance arrangements in an economically acceptable way and, particularly in the case of small shipping companies operating national transport services, account must be taken of the seasonal nature of their operations. When setting insurance arrangements under this Regulation, account should therefore be taken of the different classes of ship. (5) It is appropriate to oblige the carrier to make an advance payment in the event of the death of or personal injury to a passenger, whereby advance payment does not constitute recognition of liability. (6) Appropriate information on rights being conferred on passengers should be provided to those passengers prior to their journey or, where that is not possible, at the latest on departure. (7) The Legal Committee of the IMO adopted on 19 October 2006 the IMO Reservation and Guidelines for the Implementation of the Athens Convention (the IMO Guidelines) to address certain issues under the Athens Convention, such as, in particular, compensation for terrorism-related damage. As such, the IMO Guidelines may be considered a lex specialis. (8) This Regulation incorporates and makes binding parts of the IMO Guidelines. To that end, where it occurs in the provisions of the IMO Guidelines, the verb \u2018should\u2019 should, in particular, be understood as \u2018shall\u2019. (9) The provisions of the Athens Convention (Annex I) and of the IMO Guidelines (Annex II) should be understood, mutatis mutandis, in the context of Community legislation. (10) The system of liability provided for by this Regulation should be extended step-by-step to the different classes of ship as set out in Article 4 of Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships (4). Account should be taken of the consequences for fares and the ability of the market to obtain affordable insurance coverage at the level required against the policy background of strengthening passengers' rights and the seasonal nature of some of the traffic. (11) The matters covered by Articles 17 and 17bis of the Athens Convention fall within the exclusive competence of the Community in so far as those Articles affect the rules established by Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (5). To that extent, these two provisions will form part of the Community legal order when the Community accedes to the Athens Convention. (12) For the purposes of this Regulation, the expression \u2018or is registered in a Member State\u2019 should be considered to mean that the flag State for the purposes of bareboat charter-out registration is either a Member State or a contracting party to the Athens Convention. Necessary steps should be taken by the Member States and the Commission to invite the IMO to develop guidelines on the concept of bareboat charter-out registration. (13) For the purposes of this Regulation, the expression \u2018mobility equipment\u2019 should be considered to mean neither luggage nor vehicles within the meaning of Article 8 of the Athens Convention. (14) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6). (15) In particular, the Commission should be empowered to amend this Regulation in order to incorporate subsequent amendments to the international conventions, protocols, codes and resolutions related thereto. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (16) The European Maritime Safety Agency, established by Regulation (EC) No 1406/2002 of the European Parliament and of the Council (7), should assist the Commission in preparing and drafting a progress report on the functioning of the rules laid down by this Regulation. (17) The national authorities, particularly the port authorities, play a fundamental and vital role in identifying and managing the various risks in relation to maritime safety. (18) Member States have taken the firm commitment in their Statement on Maritime Safety of 9 October 2008 to express, no later than 1 January 2012, their consent to be bound by the International Convention on Limitation of Liability for Maritime Claims, 1976, as amended by the Protocol of 1996. Member States may make use of the option provided for in Article 15(3bis) of that Convention to regulate, by means of specific provisions of this Regulation, the system of limitation of liability to be applied to passengers. (19) Since the objective of this Regulation, namely to create a single set of rules governing the rights of carriers by sea and their passengers in the event of an accident, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter 1. This Regulation lays down the Community regime relating to liability and insurance for the carriage of passengers by sea as set out in the relevant provisions of: (a) the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 1974, as amended by the Protocol of 2002 (the Athens Convention) as set out in Annex I; and (b) the IMO Reservation and Guidelines for Implementation of the Athens Convention adopted by the Legal Committee of the IMO on 19 October 2006 (the IMO Guidelines) as set out in Annex II. 2. Furthermore, this Regulation extends the application of those provisions to carriage of passengers by sea within a single Member State on board ships of Classes A and B under Article 4 of Directive 98/18/EC, and lays down certain supplementary requirements. 3. No later than 30 June 2013, the Commission shall, if appropriate, present a legislative proposal in order, inter alia, to extend the scope of this Regulation to ships of Classes C and D under Article 4 of Directive 98/18/EC. Article 2 Scope This Regulation shall apply to any international carriage within the meaning of point 9 of Article 1 of the Athens Convention and to carriage by sea within a single Member State on board ships of Classes A and B under Article 4 of Directive 98/18/EC, where: (a) the ship is flying the flag of or is registered in a Member State; (b) the contract of carriage has been made in a Member State; or (c) the place of departure or destination, according to the contract of carriage, is in a Member State. Member States may apply this Regulation to all domestic sea-going voyages. Article 3 Liability and insurance 1. The liability regime in respect of passengers, their luggage and their vehicles and the rules on insurance or other financial security shall be governed by this Regulation, by Articles 1 and 1bis, Article 2(2), Articles 3 to16 and Articles 18, 20 and 21 of the Athens Convention set out in Annex I and by the provisions of the IMO Guidelines set out in Annex II. 2. The IMO Guidelines as set out in Annex II shall be binding. Article 4 Compensation in respect of mobility equipment or other specific equipment In the event of loss of, or damage to, mobility equipment or other specific equipment used by a passenger with reduced mobility, the liability of the carrier shall be governed by Article 3(3) of the Athens Convention. The compensation shall correspond to the replacement value of the equipment concerned or, where applicable, to the costs relating to repairs. Article 5 Global limitation of liability 1. This Regulation shall not modify the rights or duties of the carrier or performing carrier under national legislation implementing the International Convention on Limitation of Liability for Maritime Claims, 1976, as amended by the Protocol of 1996, including any future amendment thereto. In the absence of any such applicable national legislation, the liability of the carrier or performing carrier shall be governed only by Article 3 of this Regulation. 2. In respect of claims for loss of life or personal injury to a passenger caused by any of the risks referred to in paragraph 2.2 of the IMO Guidelines the carrier and the performing carrier may limit their liability pursuant to the provisions referred to in paragraph 1 of this Article. Article 6 Advance payment 1. Where the death of, or personal injury to, a passenger is caused by a shipping incident, the carrier who actually performed the whole or a part of the carriage when the shipping incident occurred shall make an advance payment sufficient to cover immediate economic needs on a basis proportionate to the damage suffered within 15 days of the identification of the person entitled to damages. In the event of the death, the payment shall not be less than EUR 21 000. This provision shall also apply where the carrier is established within the Community. 2. An advance payment shall not constitute recognition of liability and may be offset against any subsequent sums paid on the basis of this Regulation. It shall not be refundable, except in the cases set out in Article 3(1) or Article 6 of the Athens Convention or Appendix A to the IMO Guidelines, or where the person who received it is not the person entitled to damages. Article 7 Information to passengers Without prejudice to the obligations of tour operators set out in Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (8), the carrier and/or performing carrier shall ensure that passengers are provided with appropriate and comprehensible information regarding their rights under this Regulation. Where the contract of carriage is made in a Member State, that information shall be provided at all points of sale, including sale by telephone and via the Internet. Where the place of departure is in a Member State, that information shall be provided prior to departure. In all other cases, it shall be provided at the latest on departure. To the extent that the information required under this Article has been provided by either the carrier or the performing carrier, the other shall not be obliged to provide it. The information shall be provided in the most appropriate format. In order to comply with the information requirement under this Article, the carrier and performing carrier shall provide passengers with at least the information contained in a summary of the provisions of this Regulation prepared by the Commission and made public. Article 8 Reporting No later than three years after the date of application of this Regulation, the Commission shall draw up a report on the application of this Regulation, which shall, inter alia, take into account economic developments and developments in international fora. That report may be accompanied by a proposal for amendment of this Regulation, or by a proposal for a submission to be made by the Community before the relevant international fora. Article 9 Amendments 1. Measures designed to amend non-essential elements of this Regulation and relating to the incorporation of amendments to the limits set out in Article 3(1), Article 4bis(1), Article 7(1) and Article 8 of the Athens Convention to take account of decisions taken pursuant to Article 23 of that Convention, as well as corresponding updates to Annex I to this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2) of this Regulation. Taking into consideration the consequences for fares and the ability of the market to obtain affordable insurance coverage at the level required against the policy background of strengthening passengers' rights, as well as the seasonal nature of some of the traffic, by 31 December 2016, the Commission shall, on the basis of a suitable impact assessment, adopt a measure relating to the limits set out in Annex I for ships of Class B under Article 4 of Directive 98/18/EC. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2) of this Regulation. 2. Measures designed to amend non-essential elements of this Regulation and relating to the incorporation of amendments to the provisions of the IMO Guidelines set out in Annex II shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). Article 10 Committee procedure 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) established by Regulation (EC) No 2099/2002 of the European Parliament and of the Council (9). 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 11 Transitional provisions 1. In respect of carriage by sea within a single Member State on board ships of Class A under Article 4 of Directive 98/18/EC, Member States may choose to defer application of this Regulation until four years after the date of its application. 2. In respect of carriage by sea within a single Member State on board ships of Class B under Article 4 of Directive 98/18/EC, Member States may choose to defer application of this Regulation until 31 December 2018. Article 12 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from the date of the entry into force of the Athens Convention for the Community, and in any case from no later than 31 December 2012. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 23 April 2009. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President P. NE\u010cAS (1) OJ C 318, 23.12.2006, p. 195. (2) OJ C 229, 22.9.2006, p. 38. (3) Opinion of the European Parliament of 25 April 2007 (OJ C 74 E, 20.3.2008, p. 562), Council Common Position of 6 June 2008 (OJ C 190 E, 29.7.2008, p. 17), Position of the European Parliament of 24 September 2008 (not yet published in the Official Journal), Council Decision of 26 February 2009 and Legislative Resolution of the European Parliament of 11 March 2009 (not yet published in the Official Journal). (4) OJ L 144, 15.5.1998, p. 1. (5) OJ L 12, 16.1.2001, p. 1. (6) OJ L 184, 17.7.1999, p. 23. (7) OJ L 208, 5.8.2002, p. 1. (8) OJ L 158, 23.6.1990, p. 59. (9) OJ L 324, 29.11.2002, p. 1. ANNEX I PROVISIONS OF THE ATHENS CONVENTION RELATING TO THE CARRIAGE OF PASSENGERS AND THEIR LUGGAGE BY SEA RELEVANT FOR THE APPLICATION OF THIS REGULATION (Consolidated text of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 1974 and the Protocol of 2002 to the Convention) Article 1 Definitions In this Convention the following expressions have the meaning hereby assigned to them: 1. (a) \u2018carrier\u2019 means a person by or on behalf of whom a contract of carriage has been concluded, whether the carriage is actually performed by that person or by a performing carrier; (b) \u2018performing carrier\u2019 means a person other than the carrier, being the owner, charterer or operator of a ship, who actually performs the whole or a part of the carriage; and (c) \u2018carrier who actually performs the whole or a part of the carriage\u2019 means the performing carrier, or, in so far as the carrier actually performs the carriage, the carrier; 2. \u2018contract of carriage\u2019 means a contract made by or on behalf of a carrier for the carriage by sea of a passenger or of a passenger and his luggage, as the case may be; 3. \u2018ship\u2019 means only a seagoing vessel, excluding an air-cushion vehicle; 4. \u2018passenger\u2019 means any person carried in a ship: (a) under a contract of carriage; or (b) who, with the consent of the carrier, is accompanying a vehicle or live animals which are covered by a contract for the carriage of goods not governed by this Convention; 5. \u2018luggage\u2019 means any article or vehicle carried by the carrier under a contract of carriage, excluding: (a) articles and vehicles carried under a charter party, bill of lading or other contract primarily concerned with the carriage of goods; and (b) live animals; 6. \u2018cabin luggage\u2019 means luggage which the passenger has in his cabin or is otherwise in his possession, custody or control. Except for the application of paragraph 8 of this Article and Article 8, cabin luggage includes luggage which the passenger has in or on his vehicle; 7. \u2018loss of or damage to luggage\u2019 includes pecuniary loss resulting from the luggage not having been re-delivered to the passenger within a reasonable time after the arrival of the ship on which the luggage has been or should have been carried, but does not include delays resulting from labour disputes; 8. \u2018carriage\u2019 covers the following periods: (a) with regard to the passenger and his cabin luggage, the period during which the passenger and/or his cabin luggage are on board the ship or in the course of embarkation or disembarkation, and the period during which the passenger and his cabin luggage are transported by water from land to the ship or vice-versa, if the cost of such transport is included in the fare or if the vessel used for this purpose of auxiliary transport has been put at the disposal of the passenger by the carrier. However, with regard to the passenger, carriage does not include the period during which he is in a marine terminal or station or on a quay or in or on any other port installation; (b) with regard to cabin luggage, also the period during which the passenger is in a marine terminal or station or on a quay or in or on any other port installation if that luggage has been taken over by the carrier or his servant or agent and has not been re-delivered to the passenger; (c) with regard to other luggage which is not cabin luggage, the period from the time of its taking over by the carrier or his servant or agent on shore or on board until the time of its re-delivery by the carrier or his servant or agent; 9. \u2018international carriage\u2019 means any carriage in which, according to the contract of carriage, the place of departure and the place of destination are situated in two different States, or in a single State if, according to the contract of carriage or the scheduled itinerary, there is an intermediate port of call in another State; 10. \u2018Organisation\u2019 means the International Maritime Organisation; 11. \u2018Secretary-General\u2019 means the Secretary-General of the Organisation. Article 1bis Annex The Annex to this Convention shall constitute an integral part of the Convention. Article 2 Application 1. [\u2026] (1) 2. Notwithstanding paragraph 1 of this Article, this Convention shall not apply when the carriage is subject, under any other international convention concerning the carriage of passengers or luggage by another mode of transport, to a civil liability regime under the provisions of such convention, in so far as those provisions have mandatory application to carriage by sea. Article 3 Liability of the carrier 1. For the loss suffered as a result of the death of or personal injury to a passenger caused by a shipping incident, the carrier shall be liable to the extent that such loss in respect of that passenger on each distinct occasion does not exceed 250 000 units of account, unless the carrier proves that the incident: (a) resulted from an act of war, hostilities, civil war, insurrection or a natural phenomenon of an exceptional, inevitable and irresistible character; or (b) was wholly caused by an act or omission done with the intent to cause the incident by a third party. If and to the extent that the loss exceeds the above limit, the carrier shall be further liable unless the carrier proves that the incident which caused the loss occurred without the fault or neglect of the carrier. 2. For the loss suffered as a result of the death of or personal injury to a passenger not caused by a shipping incident, the carrier shall be liable if the incident which caused the loss was due to the fault or neglect of the carrier. The burden of proving fault or neglect shall lie with the claimant. 3. For the loss suffered as a result of the loss of or damage to cabin luggage, the carrier shall be liable if the incident which caused the loss was due to the fault or neglect of the carrier. The fault or neglect of the carrier shall be presumed for loss caused by a shipping incident. 4. For the loss suffered as a result of the loss of or damage to luggage other than cabin luggage, the carrier shall be liable unless the carrier proves that the incident which caused the loss occurred without the fault or neglect of the carrier. 5. For the purposes of this Article: (a) \u2018shipping incident\u2019 means shipwreck, capsizing, collision or stranding of the ship, explosion or fire in the ship, or defect in the ship; (b) \u2018fault or neglect of the carrier\u2019 includes the fault or neglect of the servants of the carrier, acting within the scope of their employment; (c) \u2018defect in the ship\u2019 means any malfunction, failure or non-compliance with applicable safety regulations in respect of any part of the ship or its equipment when used for the escape, evacuation, embarkation and disembarkation of passengers, or when used for the propulsion, steering, safe navigation, mooring, anchoring, arriving at or leaving berth or anchorage, or damage control after flooding; or when used for the launching of life saving appliances; and (d) \u2018loss\u2019 shall not include punitive or exemplary damages. 6. The liability of the carrier under this Article only relates to loss arising from incidents that occurred in the course of the carriage. The burden of proving that the incident which caused the loss occurred in the course of the carriage, and the extent of the loss, shall lie with the claimant. 7. Nothing in this Convention shall prejudice any right of recourse of the carrier against any third party, or the defence of contributory negligence under Article 6 of this Convention. Nothing in this Article shall prejudice any right of limitation under Articles 7 or 8 of this Convention. 8. Presumptions of fault or neglect of a party or the allocation of the burden of proof to a party shall not prevent evidence in favour of that party from being considered. Article 4 Performing carrier 1. If the performance of the carriage or part thereof has been entrusted to a performing carrier, the carrier shall nevertheless remain liable for the entire carriage according to the provisions of this Convention. In addition, the performing carrier shall be subject and entitled to the provisions of this Convention for the part of the carriage performed by him. 2. The carrier shall, in relation to the carriage performed by the performing carrier, be liable for the acts and omissions of the performing carrier and of his servants and agents acting within the scope of their employment. 3. Any special agreement under which the carrier assumes obligations not imposed by this Convention or any waiver of rights conferred by this Convention shall affect the performing carrier only if agreed by him expressly and in writing. 4. Where and to the extent that both the carrier and the performing carrier are liable, their liability shall be joint and several. 5. Nothing in this Article shall prejudice any right of recourse as between the carrier and the performing carrier. Article 4bis Compulsory insurance 1. When passengers are carried on board a ship registered in a State Party that is licensed to carry more than twelve passengers, and this Convention applies, any carrier who actually performs the whole or a part of the carriage shall maintain insurance or other financial security, such as the guarantee of a bank or similar financial institution, to cover liability under this Convention in respect of the death of and personal injury to passengers. The limit of the compulsory insurance or other financial security shall not be less than 250 000 units of account per passenger on each distinct occasion. 2. A certificate attesting that insurance or other financial security is in force in accordance with the provisions of this Convention shall be issued to each ship after the appropriate authority of a State Party has determined that the requirements of paragraph 1 have been complied with. With respect to a ship registered in a State Party, such certificate shall be issued or certified by the appropriate authority of the State of the ship's registry; with respect to a ship not registered in a State Party it may be issued or certified by the appropriate authority of any State Party. This certificate shall be in the form of the model set out in the annex to this Convention and shall contain the following particulars: (a) name of ship, distinctive number or letters and port of registry; (b) name and principal place of business of the carrier who actually performs the whole or a part of the carriage; (c) IMO ship identification number; (d) type and duration of security; (e) name and principal place of business of insurer or other person providing financial security and, where appropriate, place of business where the insurance or other financial security is established; and (f) period of validity of the certificate, which shall not be longer than the period of validity of the insurance or other financial security. 3. (a) A State Party may authorise an institution or an organisation recognised by it to issue the certificate. Such institution or organisation shall inform that State of the issue of each certificate. In all cases, the State Party shall fully guarantee the completeness and accuracy of the certificate so issued, and shall undertake to ensure the necessary arrangements to satisfy this obligation. (b) A State Party shall notify the Secretary-General of: (i) the specific responsibilities and conditions of the authority delegated to an institution or organisation recognised by it; (ii) the withdrawal of such authority; and (iii) the date from which such authority or withdrawal of such authority takes effect. An authority delegated shall not take effect prior to three months from the date on which notification to that effect was given to the Secretary-General. (c) The institution or organisation authorised to issue certificates in accordance with this paragraph shall, as a minimum, be authorised to withdraw these certificates if the conditions under which they have been issued are not complied with. In all cases the institution or organisation shall report such withdrawal to the State on whose behalf the certificate was issued. 4. The certificate shall be in the official language or languages of the issuing State. If the language used is not English, French or Spanish, the text shall include a translation into one of these languages, and, where the State so decides, the official language of the State may be omitted. 5. The certificate shall be carried on board the ship, and a copy shall be deposited with the authorities who keep the record of the ship's registry or, if the ship is not registered in a State Party, with the authority of the State issuing or certifying the certificate. 6. An insurance or other financial security shall not satisfy the requirements of this Article if it can cease, for reasons other than the expiry of the period of validity of the insurance or security specified in the certificate, before three months have elapsed from the date on which notice of its termination is given to the authorities referred to in paragraph 5, unless the certificate has been surrendered to these authorities or a new certificate has been issued within the said period. The foregoing provisions shall similarly apply to any modification which results in the insurance or other financial security no longer satisfying the requirements of this Article. 7. The State of the ship's registry shall, subject to the provisions of this Article, determine the conditions of issue and validity of the certificate. 8. Nothing in this Convention shall be construed as preventing a State Party from relying on information obtained from other States or the Organisation or other international organisations relating to the financial standing of providers of insurance or other financial security for the purposes of this Convention. In such cases, the State Party relying on such information is not relieved of its responsibility as a State issuing the certificate. 9. Certificates issued or certified under the authority of a State Party shall be accepted by other States Parties for the purposes of this Convention and shall be regarded by other States Parties as having the same force as certificates issued or certified by them, even if issued or certified in respect of a ship not registered in a State Party. A State Party may at any time request consultation with the issuing or certifying State should it believe that the insurer or guarantor named in the insurance certificate is not financially capable of meeting the obligations imposed by this Convention. 10. Any claim for compensation covered by insurance or other financial security pursuant to this Article may be brought directly against the insurer or other person providing financial security. In such case, the amount set out in paragraph 1 applies as the limit of liability of the insurer or other person providing financial security, even if the carrier or the performing carrier is not entitled to limitation of liability. The defendant may further invoke the defences (other than the bankruptcy or winding up) which the carrier referred to in paragraph 1 would have been entitled to invoke in accordance with this Convention. Furthermore, the defendant may invoke the defence that the damage resulted from the wilful misconduct of the assured, but the defendant shall not invoke any other defence which the defendant might have been entitled to invoke in proceedings brought by the assured against the defendant. The defendant shall in any event have the right to require the carrier and the performing carrier to be joined in the proceedings. 11. Any sums provided by insurance or by other financial security maintained in accordance with paragraph 1 shall be available exclusively for the satisfaction of claims under this Convention, and any payments made of such sums shall discharge any liability arising under this Convention to the extent of the amounts paid. 12. A State Party shall not permit a ship under its flag to which this Article applies to operate at any time unless a certificate has been issued under paragraphs 2 or 15. 13. Subject to the provisions of this Article, each State Party shall ensure, under its national law, that insurance or other financial security, to the extent specified in paragraph 1, is in force in respect of any ship that is licensed to carry more than twelve passengers, wherever registered, entering or leaving a port in its territory in so far as this Convention applies. 14. Notwithstanding the provisions of paragraph 5, a State Party may notify the Secretary-General that, for the purposes of paragraph 13, ships are not required to carry on board or to produce the certificate required by paragraph 2 when entering or leaving ports in its territory, provided that the State Party which issues the certificate has notified the Secretary-General that it maintains records in an electronic format, accessible to all States Parties, attesting the existence of the certificate and enabling States Parties to discharge their obligations under paragraph 13. 15. If insurance or other financial security is not maintained in respect of a ship owned by a State Party, the provisions of this Article relating thereto shall not be applicable to such ship, but the ship shall carry a certificate issued by the appropriate authorities of the State of the ship's registry, stating that the ship is owned by that State and that the liability is covered within the amount prescribed in accordance with paragraph 1. Such a certificate shall follow as closely as possible the model prescribed by paragraph 2. Article 5 Valuables The carrier shall not be liable for the loss of or damage to monies, negotiable securities, gold, silverware, jewellery, ornaments, works of art, or other valuables, except where such valuables have been deposited with the carrier for the agreed purpose of safe-keeping in which case the carrier shall be liable up to the limit provided for in paragraph 3 of Article 8 unless a higher limit is agreed upon in accordance with paragraph 1 of Article 10. Article 6 Contributory fault If the carrier proves that the death of or personal injury to a passenger or the loss of or damage to his luggage was caused or contributed to by the fault or neglect of the passenger, the Court seized of the case may exonerate the carrier wholly or partly from his liability in accordance with the provisions of the law of that court. Article 7 Limit of liability for death and personal injury 1. The liability of the carrier for the death of or personal injury to a passenger under Article 3 shall in no case exceed 400 000 units of account per passenger on each distinct occasion. Where, in accordance with the law of the court seized of the case, damages are awarded in the form of periodical income payments, the equivalent capital value of those payments shall not exceed the said limit. 2. A State Party may regulate by specific provisions of national law the limit of liability prescribed in paragraph 1, provided that the national limit of liability, if any, is not lower than that prescribed in paragraph 1. A State Party, which makes use of the option provided for in this paragraph, shall inform the Secretary-General of the limit of liability adopted or of the fact that there is none. Article 8 Limit of liability for loss of or damage to luggage and vehicles 1. The liability of the carrier for the loss of or damage to cabin luggage shall in no case exceed 2 250 units of account per passenger, per carriage. 2. The liability of the carrier for the loss of or damage to vehicles including all luggage carried in or on the vehicle shall in no case exceed 12 700 units of account per vehicle, per carriage. 3. The liability of the carrier for the loss of or damage to luggage other than that mentioned in paragraphs 1 and 2 shall in no case exceed 3 375 units of account per passenger, per carriage. 4. The carrier and the passenger may agree that the liability of the carrier shall be subject to a deductible not exceeding 330 units of account in the case of damage to a vehicle and not exceeding 149 units of account per passenger in the case of loss of or damage to other luggage, such sum to be deducted from the loss or damage. Article 9 Unit of Account and conversion 1. The Unit of Account mentioned in this Convention is the Special Drawing Right as defined by the International Monetary Fund. The amounts mentioned in Article 3(1), Article 4bis(1), Article 7(l) and Article 8 shall be converted into the national currency of the State of the court seized of the case on the basis of the value of that currency by reference to the Special Drawing Right on the date of the judgment or the date agreed upon by the parties. The value of the national currency, in terms of the Special Drawing Right, of a State Party which is a member of the International Monetary Fund, shall be calculated in accordance with the method of valuation applied by the International Monetary Fund in effect on the date in question for its operations and transactions. The value of the national currency, in terms of the Special Drawing Right, of a State Party which is not a member of the International Monetary Fund, shall be calculated in a manner determined by that State Party. 2. Nevertheless, a State which is not a member of the International Monetary Fund and whose law does not permit the application of the provisions of paragraph 1 may, at the time of ratification, acceptance, approval of or accession to this Convention or at any time thereafter, declare that the Unit of Account referred to in paragraph 1 shall be equal to 15 gold francs. The gold franc referred to in this paragraph corresponds to sixty-five and a half milligrams of gold of millesimal fineness nine hundred. The conversion of the gold franc into the national currency shall be made according to the law of the State concerned. 3. The calculation mentioned in the last sentence of paragraph 1, and the conversion mentioned in paragraph 2 shall be made in such a manner as to express in the national currency of the States Parties, as far as possible, the same real value for the amounts in Article 3(1), Article 4bis(1), Article 7(1) and Article 8 as would result from the application of the first three sentences of paragraph 1. States shall communicate to the Secretary-General the manner of calculation pursuant to paragraph 1, or the result of the conversion in paragraph 2, as the case may be, when depositing an instrument of ratification, acceptance, approval of or accession to this Convention and whenever there is a change in either. Article 10 Supplementary provisions on limits of liability 1. The carrier and the passenger may agree, expressly and in writing, to higher limits of liability than those prescribed in Articles 7 and 8. 2. Interest on damages and legal costs shall not be included in the limits of liability prescribed in Articles 7 and 8. Article 11 Defences and limits for carriers' servants If an action is brought against a servant or agent of the carrier or of the performing carrier arising out of damage covered by this Convention, such servant or agent, if he proves that he acted within the scope of his employment, shall be entitled to avail himself of the defences and limits of liability which the carrier or the performing carrier is entitled to invoke under this Convention. Article 12 Aggregation of claims 1. Where the limits of liability prescribed in Articles 7 and 8 take effect, they shall apply to the aggregate of the amounts recoverable in all claims arising out of the death of or personal injury to any one passenger or the loss of or damage to his luggage. 2. In relation to the carriage performed by a performing carrier, the aggregate of the amounts recoverable from the carrier and the performing carrier and from their servants and agents acting within the scope of their employment shall not exceed the highest amount which could be awarded against either the carrier or the performing carrier under this Convention, but none of the persons mentioned shall be liable for a sum in excess of the limit applicable to him. 3. In any case where a servant or agent of the carrier or of the performing carrier is entitled under Article 11 of this Convention to avail himself of the limits of liability prescribed in Articles 7 and 8, the aggregate of the amounts recoverable from the carrier, or the performing carrier as the case may be, and from that servant or agent, shall not exceed those limits. Article 13 Loss of right to limit liability 1. The carrier shall not be entitled to the benefit of the limits of liability prescribed in Articles 7 and 8 and Article 10(1), if it is proved that the damage resulted from an act or omission of the carrier done with the intent to cause such damage, or recklessly and with knowledge that such damage would probably result. 2. The servant or agent of the carrier or of the performing carrier shall not be entitled to the benefit of those limits if it is proved that the damage resulted from an act or omission of that servant or agent done with the intent to cause such damage, or recklessly and with knowledge that such damage would probably result. Article 14 Basis for claims No action for damages for the death of or personal injury to a passenger, or for the loss of or damage to luggage, shall be brought against a carrier or performing carrier otherwise than in accordance with this Convention. Article 15 Notice of loss or damage to luggage 1. The passenger shall give written notice to the carrier or his agent: (a) in the case of apparent damage to luggage: (i) for cabin luggage, before or at the time of disembarkation of the passenger; (ii) for all other luggage, before or at the time of its re-delivery; (b) in the case of damage to luggage which is not apparent, or loss of luggage, within 15 days from the date of disembarkation or re-delivery or from the time when such re-delivery should have taken place. 2. If the passenger fails to comply with this Article, he shall be presumed, unless the contrary is proved, to have received the luggage undamaged. 3. The notice in writing need not be given if the condition of the luggage has at the time of its receipt been the subject of joint survey or inspection. Article 16 Time-bar for actions 1. Any action for damages arising out of the death of or personal injury to a passenger or for the loss of or damage to luggage shall be time-barred after a period of two years. 2. The limitation period shall be calculated as follows: (a) in the case of personal injury, from the date of disembarkation of the passenger; (b) in the case of death occurring during carriage, from the date when the passenger should have disembarked, and in the case of personal injury occurring during carriage and resulting in the death of the passenger after disembarkation, from the date of death, provided that this period shall not exceed three years from the date of disembarkation; (c) in the case of loss of or damage to luggage, from the date of disembarkation or from the date when disembarkation should have taken place, whichever is later. 3. The law of the Court seized of the case shall govern the grounds for suspension and interruption of limitation periods, but in no case shall an action under this Convention be brought after the expiration of any one of the following periods of time: (a) a period of five years beginning with the date of disembarkation of the passenger or from the date when disembarkation should have taken place, whichever is later; or, if earlier; (b) a period of three years beginning with the date when the claimant knew or ought reasonably to have known of the injury, loss or damage caused by the incident. 4. Notwithstanding paragraphs 1, 2 and 3 of this Article, the period of limitation may be extended by a declaration of the carrier or by agreement of the parties after the cause of action has arisen. The declaration or agreement shall be in writing. Article 17 Competent jurisdiction (2) Article 17bis Recognition and enforcement (2) Article 18 Invalidity of contractual provisions Any contractual provision concluded before the occurrence of the incident which has caused the death of or personal injury to a passenger or the loss of or damage to the passenger's luggage, purporting to relieve any person liable under this Convention of liability towards the passenger or to prescribe a lower limit of liability than that fixed in this Convention except as provided in Article 8, paragraph 4, and any such provision purporting to shift the burden of proof which rests on the carrier or performing carrier, or having the effect of restricting the options specified in Article 17, paragraphs 1 or 2, shall be null and void, but the nullity of that provision shall not render void the contract of carriage which shall remain subject to the provisions of this Convention. Article 20 Nuclear damage No liability shall arise under this Convention for damage caused by a nuclear incident: (a) if the operator of a nuclear installation is liable for such damage under either the Paris Convention of 29 July 1960 on Third Party Liability in the Field of Nuclear Energy as amended by its Additional Protocol of 28 January 1964, or the Vienna Convention of 21 May 1963 on Civil Liability for Nuclear Damage, or any amendment or Protocol thereto which is in force; or (b) if the operator of a nuclear installation is liable for such damage by virtue of a national law governing the liability for such damage, provided that such law is in all respects as favourable to persons who may suffer damage as either the Paris or the Vienna Conventions or any amendment or Protocol thereto which is in force. Article 21 Commercial carriage by public authorities This Convention shall apply to commercial carriage undertaken by States or Public Authorities under contract of carriage within the meaning of Article 1. [Articles 22 and 23 of the Protocol of 2002 to the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 1974] Article 22 Revision and amendment (3) Article 23 Amendment of limits 1. Without prejudice to the provisions of Article 22, the special procedure in this Article shall apply solely for the purposes of amending the limits set out in Article 3(1), Article 4bis(1), Article 7(1) and Article 8 of the Convention as revised by this Protocol. 2. Upon the request of at least one half, but in no case less than six, of the States Parties to this Protocol, any proposal to amend the limits, including the deductibles, specified in Article 3(1), Article 4bis(1), Article 7(1) and Article 8 of the Convention as revised by this Protocol shall be circulated by the Secretary General to all Members of the Organisation and to all States Parties. 3. Any amendment proposed and circulated as above shall be submitted to the Legal Committee of the Organisation (hereinafter referred to as \u2018the Legal Committee\u2019) for consideration at a date at least six months after the date of its circulation. 4. All States Parties to the Convention as revised by this Protocol, whether or not Members of the Organisation, shall be entitled to participate in the proceedings of the Legal Committee for the consideration and adoption of amendments. 5. Amendments shall be adopted by a two thirds majority of the States Parties to the Convention as revised by this Protocol present and voting in the Legal Committee expanded as provided for in paragraph 4, on condition that at least one half of the States Parties to the Convention as revised by this Protocol shall be present at the time of voting. 6. When acting on a proposal to amend the limits, the Legal Committee shall take into account the experience of incidents and, in particular, the amount of damage resulting therefrom, changes in the monetary values and the effect of the proposed amendment on the cost of insurance. 7. (a) No amendment of the limits under this Article may be considered less than five years from the date on which this Protocol was opened for signature nor less than five years from the date of entry into force of a previous amendment under this Article. (b) No limit may be increased so as to exceed an amount which corresponds to the limit laid down in the Convention as revised by this Protocol increased by six per cent per year calculated on a compound basis from the date on which this Protocol was opened for signature. (c) No limit may be increased so as to exceed an amount which corresponds to the limit laid down in the Convention as revised by this Protocol multiplied by three. 8. Any amendment adopted in accordance with paragraph 5 shall be notified by the Organisation to all States Parties. The amendment shall be deemed to have been accepted at the end of a period of 18 months after the date of notification, unless within that period not less than one fourth of the States that were States Parties at the time of the adoption of the amendment have communicated to the Secretary General that they do not accept the amendment, in which case the amendment is rejected and shall have no effect. 9. An amendment deemed to have been accepted in accordance with paragraph 8 shall enter into force 18 months after its acceptance. 10. All States Parties shall be bound by the amendment, unless they denounce this Protocol in accordance with Article 21, paragraphs 1 and 2 at least six months before the amendment enters into force. Such denunciation shall take effect when the amendment enters into force. 11. When an amendment has been adopted but the 18 month period for its acceptance has not yet expired, a State which becomes a State Party during that period shall be bound by the amendment if it enters into force. A State which becomes a State Party after that period shall be bound by an amendment which has been accepted in accordance with paragraph 8. In the cases referred to in this paragraph, a State becomes bound by an amendment when that amendment enters into force, or when this Protocol enters into force for that State, if later. ANNEX TO ATHENS CONVENTION CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY IN RESPECT OF LIABILITY FOR THE DEATH OF AND PERSONAL INJURY TO PASSENGERS Issued in accordance with the provisions of Article 4bis of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002 Name of ship Distinctive number or letters IMO ship identification number Port of registry Name and full address of the principal place of business of the carrier who actually performs the carriage This is to certify that there is in force in respect of the abovenamed ship a policy of insurance or other financial security satisfying the requirements of Article 4bis of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002. Type of security \u2026 Duration of security \u2026 Name and address of the insurer(s) and/or guarantor(s) Name \u2026 Address \u2026 This certificate is valid until \u2026 Issued or certified by the Government of \u2026 (Full designation of the State) OR The following text should be used when a State Party avails itself of Article 4bis, paragraph 3: The present certificate is issued under the authority of the Government of \u2026 (full designation of the State) by \u2026 (name of institution or organisation) At \u2026On \u2026 (Place) (Date) \u2026 (Signature and title of issuing or certifying official) Explanatory notes: 1. If desired, the designation of the State may include a reference to the competent public authority of the country where the Certificate is issued. 2. If the total amount of security has been furnished by more than one source, the amount of each of them should be indicated. 3. If security is furnished in several forms, these should be enumerated. 4. The entry \u2018Duration of Security\u2019 must stipulate the date on which such security takes effect. 5. The entry \u2018Address\u2019 of the insurer(s) and/or guarantor(s) must indicate the principal place of business of the insurer(s) and/or guarantor(s). If appropriate, the place of business where the insurance or other security is established shall be indicated. (1) Not reproduced. (2) Not reproduced. (3) Not reproduced. ANNEX II Extract From the IMO Reservation and Guidelines for Implementation of THE ATHENS Convention, adopted by the Legal Committee of the INTERNATIONAL MARITIME ORGANISATION on 19 October 2006 IMO RESERVATION AND GUIDELINES FOR IMPLEMENTATION OF THE ATHENS CONVENTION Reservation 1. The Athens Convention should be ratified with the following reservation or a declaration to the same effect: \u2018[1.1.] Reservation in connection with the ratification by the Government of \u2026 of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002 (the Convention) Limitation of liability of carriers, etc. [1.2.] The Government of \u2026 reserves the right to and undertakes to limit liability under paragraph 1 or 2 of Article 3 of the Convention, if any, in respect of death of or personal injury to a passenger caused by any of the risks referred to in paragraph 2.2 of the IMO Guidelines for Implementation of the Athens Convention to the lower of the following amounts: \u2014 250 000 units of account in respect of each passenger on each distinct occasion, or \u2014 340 million units of account overall per ship on each distinct occasion. [1.3.] Furthermore, the Government of \u2026 reserves the right to and undertakes to apply the IMO Guidelines for Implementation of the Athens Convention paragraphs 2.1.1 and 2.2.2 mutatis mutandis, to such liabilities. [1.4.] The liability of the performing carrier pursuant to Article 4 of the Convention, the liability of the servants and agents of the carrier or the performing carrier pursuant to Article 11 of the Convention and the limit of the aggregate of the amounts recoverable pursuant to Article 12 of the Convention shall be limited in the same way. [1.5.] The reservation and undertaking in paragraph 1.2 will apply regardless of the basis of liability under paragraph 1 or 2 of Article 3 and notwithstanding anything to the contrary in Article 4 or 7 of the Convention; but this reservation and undertaking do not affect the operation of Articles 10 and 13. Compulsory insurance and limitation of liability of insurers [1.6.] The Government of \u2026 reserves the right to and undertakes to limit the requirement under paragraph 1 of Article 4bis to maintain insurance or other financial security for death or personal injury to a passenger caused by any of the risks referred to in paragraph 2.2 of the IMO Guidelines for Implementation of the Athens Convention to the lower of the following amounts: \u2014 250 000 units of account in respect of each passenger on each distinct occasion, or \u2014 340 million units of account overall per ship on each distinct occasion. [1.7.] The Government of \u2026 reserves the right to and undertakes to limit the liability of the insurer or other person providing financial security under paragraph 10 of Article 4bis, for death or personal injury to a passenger caused by any of the risks referred to in paragraph 2.2 of the IMO Guidelines for Implementation of the Athens Convention, to a maximum limit of the amount of insurance or other financial security which the carrier is required to maintain under paragraph 1.6 of this reservation. [1.8.] The Government of \u2026 also reserves the right to and undertakes to apply the IMO Guidelines for Implementation of the Athens Convention including the application of the clauses referred to in paragraphs 2.1 and 2.2 in the Guidelines in all compulsory insurance under the Convention. [1.9.] The Government of \u2026 reserves the right to and undertakes to exempt the provider of insurance or other financial security under paragraph 1 of Article 4bis from any liability for which he has not undertaken to be liable. Certification [1.10.] The Government of \u2026 reserves the right to and undertakes to issue insurance certificates under paragraph 2 of Article 4bis of the Convention so as: \u2014 to reflect the limitations of liability and the requirements for insurance cover referred to in paragraphs 1.2, 1.6, 1.7 and 1.9, and \u2014 to include such other limitations, requirements and exemptions as it finds that the insurance market conditions at the time of the issue of the certificate necessitate. [1.11.] The Government of \u2026 reserves the right to and undertakes to accept insurance certificates issued by other States Parties issued pursuant to a similar reservation. [1.12.] All such limitations, requirements and exemptions will be clearly reflected in the Certificate issued or certified under paragraph 2 of Article 4bis of the Convention. Relationship between this Reservation and the IMO Guidelines for Implementation of the Athens Convention [1.13.] The rights retained by this reservation will be exercised with due regard to the IMO Guidelines for Implementation of the Athens Convention, or to any amendments thereto, with an aim to ensure uniformity. If a proposal to amend the IMO Guidelines for Implementation of the Athens Convention, including the limits, has been approved by the Legal Committee of the International Maritime Organisation, those amendments will apply as from the time determined by the Committee. This is without prejudice to the rules of international law regarding the right of a State to withdraw or amend its reservation.\u2019 Guidelines 2. In the current state of the insurance market, State Parties should issue insurance certificates on the basis of one undertaking from an insurer covering war risks, and another insurer covering non war risks. Each insurer should only be liable for its part. The following rules should apply (the clauses referred to are set out in Appendix A): 2.1. Both war and non war insurance may be subject to the following clauses: 2.1.1. Institute Radioactive Contamination, Chemical, Biological, Bio-chemical and Electromagnetic Weapons Exclusion Clause (Institute clause No 370); 2.1.2. Institute Cyber Attack Exclusion Clause (Institute clause No 380); 2.1.3. the defences and limitations of a provider of compulsory financial security under the Convention as modified by these guidelines, in particular the limit of 250 000 units of account per passenger on each distinct occasion; 2.1.4. the proviso that the insurance shall only cover liabilities subject to the Convention as modified by these guidelines; and 2.1.5. the proviso that any amounts settled under the Convention shall serve to reduce the outstanding liability of the carrier and/or its insurer under Article 4bis of the Convention even if they are not paid by or claimed from the respective war or non war insurers. 2.2. War insurance shall cover liability, if any; for the loss suffered as a result of death or personal injury to passenger caused by: \u2014 war, civil war, revolution, rebellion, insurrection, or civil strife arising there from, or any hostile act by or against a belligerent power, \u2014 capture, seizure, arrest, restraint or detainment, and the consequences thereof or any attempt thereat, \u2014 derelict mines, torpedoes, bombs or other derelict weapons of war, \u2014 act of any terrorist or any person acting maliciously or from a political motive and any action taken to prevent or counter any such risk, \u2014 confiscation and expropriation, and may be subject to the following exemptions, limitations and requirements: 2.2.1. War Automatic Termination and Exclusion Clause 2.2.2. In the event the claims of individual passengers exceed in the aggregate the sum of 340 million units of account overall per ship on any distinct occasion, the carrier shall be entitled to invoke limitation of his liability in the amount of 340 million units of account, always provided that: \u2014 this amount should be distributed amongst claimants in proportion to their established claims, \u2014 the distribution of this amount may be made in one or more portions to claimants known at the time of the distribution, and \u2014 the distribution of this amount may be made by the insurer, or by the Court or other competent authority seized by the insurer in any State Party in which legal proceedings are instituted in respect of claims allegedly covered by the insurance. 2.2.3. 30 days notice clause in cases not covered by 2.2.1. 2.3. Non-war insurance should cover all perils subject to compulsory insurance other than those risks listed in 2.2, whether or not they are subject to exemptions, limitations or requirements in 2.1 and 2.2. 3. An example of a set of insurance undertakings (Blue Cards) and an insurance certificate, all reflecting these guidelines, are included in Appendix B. APPENDIX A Clauses referred to in guidelines 2.1.1, 2.1.2 and 2.2.1 Institute Radioactive Contamination, Chemical, Biological, Bio-chemical and Electromagnetic Exclusion Clause (Cl. 370, 10/11/2003) This clause shall be paramount and shall override anything contained in this insurance inconsistent therewith 1. In no case shall this insurance cover loss damage liability or expense directly or indirectly caused by or contributed to by or arising from: 1.1. ionising radiations from or contamination by radioactivity from any nuclear fuel or from any nuclear waste or from the combustion of nuclear fuel; 1.2. the radioactive, toxic, explosive or other hazardous or contaminating properties of any nuclear installation, reactor or other nuclear assembly or nuclear component thereof; 1.3. any weapon or device employing atomic or nuclear fission and/or fusion or other like reaction or radioactive force or matter; 1.4. the radioactive, toxic, explosive or other hazardous or contaminating properties of any radioactive matter. The exclusion in this sub clause does not extend to radioactive isotopes, other than nuclear fuel, when such isotopes are being prepared, carried, stored, or used for commercial, agricultural, medical, scientific or other similar peaceful purposes; 1.5. any chemical, biological, bio chemical, or electromagnetic weapon. Institute Cyber Attack Exclusion Clause (Cl. 380, 10/11/03) 1. Subject only to clause 10.2 below, in no case shall this insurance cover loss damage liability or expense directly or indirectly caused by or contributed to by or arising from the use or operation, as a means for inflicting harm, of any computer, computer system, computer software programme, malicious code, computer virus or process or any other electronic system. 2. Where this clause is endorsed on policies covering risks of war, civil war, revolution, rebellion, insurrection, or civil strife arising therefrom, or any hostile act by or against a belligerent power, or terrorism or any person acting from a political motive, Clause 10.1 shall not operate to exclude losses (which would otherwise be covered) arising from the use of any computer, computer system or computer software programme or any other electronic system in the launch and/or guidance system and/or firing mechanism of any weapon or missile. War Automatic Termination and Exclusion 1.1. Automatic Termination of Cover Whether or not such notice of cancellation has been given cover hereunder shall TERMINATE AUTOMATICALLY 1.1.1. upon the outbreak of war (whether there be a declaration of war or not) between any of the following: United Kingdom, United States of America, France, the Russian Federation, the People's Republic of China; 1.1.2. in respect of any vessel, in connection with which cover is granted hereunder, in the event of such vessel being requisitioned either for title or use. 1.2. Five Powers War This insurance excludes 1.2.1. loss damage liability or expense arising from the outbreak of war (whether there be a declaration of war or not) between any of the following: United Kingdom, United States of America, France, the Russian Federation, the People's Republic of China; 1.2.2. requisition either for title or use. APPENDIX B I. Examples of insurance undertakings (Blue Cards) referred to in guideline 3 Blue Card issued by War Insurer Certificate furnished as evidence of insurance pursuant to Article 4bis of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002. Name of Ship: IMO Ship Identification Number: Port of registry: Name and Address of owner: This is to certify that there is in force in respect of the above named ship while in the above ownership a policy of insurance satisfying the requirements of Article 4bis of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002, subject to all exceptions and limitations allowed for compulsory war insurance under the Convention and the implementation guidelines adopted by the Legal Committee of the International Maritime Organisation in October 2006, including in particular the following clauses: [Here the text of the Convention and the guidelines with appendices can be inserted to the extent desirable] Period of insurance from: 20 February 2007 to: 20 February 2008 Provided always that the insurer may cancel this certificate by giving 30 days written notice to the above Authority whereupon the liability of the insurer hereunder shall cease as from the date of the expiry of the said period of notice but only as regards incidents arising thereafter. Date: This certificate has been issued by: War Risks, Inc [Address] \u2026 Signature of insurer As agent only for War Risks, Inc. Blue Card issued by Non-War Insurer Certificate furnished as evidence of insurance pursuant to Article 4bis of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002 Name of Ship: IMO Ship Identification Number: Port of registry: Name and Address of owner: This is to certify that there is in force in respect of the above named ship while in the above ownership a policy of insurance satisfying the requirements of Article 4bis of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002, subject to all exceptions and limitations allowed for non-war insurers under the Convention and the implementation guidelines adopted by the Legal Committee of the International Maritime Organisation in October 2006, including in particular the following clauses: [Here the text of the Convention and the guidelines with appendices can be inserted to the extent desirable] Period of insurance from: 20 February 2007 to: 20 February 2008 Provided always that the insurer may cancel this certificate by giving three months written notice to the above Authority whereupon the liability of the insurer hereunder shall cease as from the date of the expiry of the said period of notice but only as regards incidents arising thereafter. Date: This certificate has been issued by: PANDI P&I [Address] \u2026 Signature of insurer As agent only for PANDI P&I II. Model of certificate of insurance referred to in guideline 3 CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY IN RESPECT OF LIABILITY FOR THE DEATH OF AND PERSONAL INJURY TO PASSENGERS Issued in accordance with the provisions of Article 4bis of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002 Name of ship Distinctive number or letters IMO ship identification number Port of registry Name and full address of the principal place of business of the carrier who actually performs the carriage This is to certify that there is in force in respect of the abovenamed ship a policy of insurance or other financial security satisfying the requirements of Article 4bis of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 2002. Type of Security \u2026 Duration of Security \u2026 Name and address of the insurer(s) and/or guarantor(s) The insurance cover hereby certified is split in one war insurance part and one non-war insurance part, pursuant to the implementation guidelines adopted by the Legal Committee of the International Maritime Organisation in October 2006. Each of these parts of the insurance cover is subject to all exceptions and limitations allowed under the Convention and the implementation guidelines. The insurers are not jointly and severally liable. The insurers are: For war risks: War Risks, Inc., [address] For non-war risks: Pandi P&I, [address] This certificate is valid until \u2026 Issued or certified by the Government of \u2026 (Full designation of the State) OR The following text should be used when a State Party avails itself of Article 4bis, paragraph 3: The present certificate is issued under the authority of the Government of \u2026 (full designation of the State) by \u2026 (name of institution or organisation) At \u2026 On \u2026 (Place) (Date) \u2026 (Signature and title of issuing or certifying official) Explanatory notes: 1. If desired, the designation of the State may include a reference to the competent public authority of the country where the certificate is issued. 2. If the total amount of security has been furnished by more than one source, the amount of each of them should be indicated. 3. If security is furnished in several forms, these should be enumerated. 4. The entry \u2018Duration of Security\u2019 must stipulate the date on which such security takes effect. 5. The entry \u2018Address\u2019 of the insurer(s) and/or guarantor(s) must indicate the principal place of business of the insurer(s) and/or guarantor(s). If appropriate, the place of business where the insurance or other security is established shall be indicated.", "summary": "Liability of ship owners in the event of accidents Liability of ship owners in the event of accidents Passengers involved in maritime accidents must have an adequate level of compensation for any loss or damage they suffer. To ensure this, ship owners must have appropriate insurance arrangements in place. ACT Regulation (EC) No 392/2009 of the European Parliament and of the Council of 23 April 2009 on the liability of carriers of passengers by sea in the event of accidents SUMMARY WHAT DOES THE REGULATION DO? It lays down harmonised rules on liability and insurance for shipping companies carrying passengers by sea. It introduces into European law the provisions of the 1974 Athens Convention on the carriage of passengers and their luggage by sea and guidelines from the International Maritime Organisation. KEY POINTS The legislation applies to all ships flying an EU country flag, travelling to or from a European port, or under a European contract of carriage (i.e. a contract between the carrier and its passengers defining rights, duties and liabilities). The legislation currently applies to both international and domestic voyages, but it does not apply to domestic voyages in the course of which the ship is less than 5 miles from the coastline. The operators\u2019 liability covers passengers and their luggage and vehicles, as well as mobility equipment for persons with reduced mobility. For any injury or damage caused by a shipping incident (i.e. shipwreck, capsizing, collision or stranding, fire or explosion, or other defect of the ship), victims do not need to prove fault on the part of the carrier in order to be compensated. Ship operators must make an advance payment to cover the immediate economic needs of a passenger who is killed or injured in a shipping incident. This payment does not imply the shipping company acknowledges liability. The minimum advance payment for the death of a passenger is \u20ac21,000. Shipping companies must provide passengers with understandable information on their rights. This information must be available at all points of sale, including by phone and the internet, and provided before, or at the latest on, departure. The European Commission, no later than 3 years after the legislation takes effect (31 December 2012), must produce a report on how it is being applied. EU governments may postpone application of the legislation for ships involved in purely domestic voyages covered by the regulation. For vessels which travel less than 20 miles from the shore, the deadline is 31 December 2018 at the latest. For all others, the deadline is 31 December 2016. SINCE WHEN DOES THE REGULATION APPLY? From 29 May 2009. For more information, see Passenger rights on the European Commission\u2019s website. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 392/2009 29.5.2009 - OJ L 131, 28.5.2009, pp. 24-46 last update 30.09.2015"}
{"article": "20.10.2010 EN Official Journal of the European Union L 276/22 REGULATION (EU) No 913/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 concerning a European rail network for competitive freight (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91 thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Within the framework of the European Union new Strategy for jobs and growth, the creation of an internal rail market, in particular with regard to freight transport, is an essential factor in making progress towards sustainable mobility. (2) Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways (4) and Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure (5) have been important steps in the creation of the internal rail market. (3) In order to be competitive with other modes of transport, international and national rail freight services, which have been opened up to competition since 1 January 2007, must be able to benefit from a good quality and sufficiently financed railway infrastructure, namely, one which allows freight transport services to be provided under good conditions in terms of commercial speed and journey times and to be reliable, namely, that the service it provides actually corresponds to the contractual agreements entered into with the railway undertakings. (4) Although the opening of the rail freight market has made it possible for new operators to enter the rail network, market mechanisms have not been and are not sufficient to organise, regulate and secure rail freight traffic. To optimise the use of the network and ensure its reliability it is useful to introduce additional procedures to strengthen cooperation on allocation of international train paths for freight trains between infrastructure managers. (5) In this context, the establishment of international rail corridors for a European rail network for competitive freight on which freight trains can run under good conditions and easily pass from one national network to another would allow for improvements in the conditions of use of the infrastructure. (6) In order to establish international rail corridors for a European rail network for competitive freight, the initiatives already taken in terms of railway infrastructure show that the establishment of international corridors, which meet specific needs in one or more clearly identified segments of the freight market, is the most appropriate method. (7) This Regulation should, unless otherwise provided, be without prejudice to the rights and obligations of infrastructure managers set out in Directive 91/440/EEC and Directive 2001/14/EC and, where relevant, allocation bodies as referred to in Article 14(2) of Directive 2001/14/EC. Those acts remain in force, including in respect of provisions which affect freight corridors. (8) The establishment of a freight corridor should take into account, where appropriate, the need for better interconnections with the rail infrastructure of European third countries. (9) The design of freight corridors should seek to ensure continuity along the corridors by enabling the required interconnections between existing railway infrastructure. (10) The implementation of international rail freight corridors forming a European rail network for competitive freight should be conducted in a manner consistent with the trans-European Transport Network (TEN-T) and/or the European Railway Traffic Management System (ERTMS) corridors. To that end, the coordinated development of the networks is necessary, and in particular as regards the integration of the international corridors for rail freight into the existing TEN-T and the ERTMS corridors. Furthermore, harmonising rules relating to those freight corridors should be established at Union level. Projects aimed at reducing noise from freight trains should be encouraged. If necessary, the establishment of those corridors should be supported financially within the framework of the TEN-T, research and Marco Polo programmes, and other Union policies and funds, such as the European Regional Development Fund or the Cohesion Fund as well as the European Investment Bank. (11) Within the framework of a freight corridor, good coordination between the Member States and the infrastructure managers concerned should be ensured, sufficient priority should be given to rail freight traffic, effective and adequate links to other modes of transport should be set up and conditions should be created which are favourable to the development of competition between rail freight service providers. (12) Further to the freight corridors set up in accordance with Article 3, the establishment of additional freight corridors should be examined and approved at Union level in accordance with clearly defined transparent procedures and criteria which allow Member States and infrastructure managers sufficient decision-making and management scope so that they can take into account existing initiatives for special corridors, e.g. ERTMS, RailNetEurope (RNE) and TEN-T, and take measures adapted to their specific needs. (13) In order to stimulate coordination between the Member States and the infrastructure managers and to provide continuity along the corridor, an appropriate governance structure for each freight corridor should be established, taking into account the need to avoid duplication with already existing governance structures. (14) In order to meet market needs, the methods for establishing a freight corridor should be presented in an implementation plan, which should include identifying and setting a schedule for measures which would improve the performance of rail freight. Furthermore, to ensure that planned or implemented measures for the establishment of a freight corridor meet the needs or expectations of all of the users of the freight corridor, the applicants likely to use the freight corridor must be regularly consulted in accordance with procedures defined by the management board. (15) The development of intermodal freight terminals should also be considered necessary to support the establishment of rail freight corridors in the Union. (16) In order to guarantee the consistency and continuity of the infrastructure capacities available along the freight corridor, investment in the freight corridor should be coordinated between Member States and the infrastructure managers concerned, as well as, where appropriate, between Member States and European third countries, and planned in a way which meets, subject to economic viability, the needs of the freight corridor. The schedule for carrying out the investment should be published to ensure that applicants who may operate in the corridor are well informed. The investment should include projects relating to the development of interoperable systems and the increase in capacity of the trains. (17) For the same reasons, all the works on infrastructure and its equipment that would restrict available capacity on the freight corridor should also be coordinated at the level of the freight corridor and be the subject of updated publications. (18) In order to facilitate requests for infrastructure capacities for international rail freight services, it is appropriate to designate or establish a one-stop shop for each freight corridor. For this, existing initiatives should be built upon, in particular those undertaken by RNE, a body which acts as a coordination tool for the infrastructure managers and provides a number of services to international freight undertakings. (19) The management of freight corridors should also include procedures for the allocation of the infrastructure capacity for international freight trains running on such corridors. Those procedures should recognise the need for capacity of other types of transport, including passenger transport. (20) To ensure that the railway infrastructure is better used, the operation of that infrastructure and the terminals along the freight corridor need to be coordinated. (21) Priority rules may also mean priority targets depending on the situation in the respective Member State. (22) Freight trains running on the freight corridor should be able to enjoy, as far as possible, sufficient punctuality in the event of disturbance with regard to the needs of all types of transport. (23) In order to promote the development of competition between providers of rail freight services on the freight corridor, applicants other than railway undertakings or their groupings should be allowed to request infrastructure capacity on the freight corridors. (24) In order to evaluate objectively the benefits of the measures aimed at the establishment of the freight corridor, the performance of the rail freight services along the freight corridor should be monitored and quality reports should be published regularly. The evaluation of the performance should include the outcome of satisfaction surveys of the users of the freight corridor. (25) In order to ensure non-discriminatory access to international rail services, it is necessary to ensure efficient coordination between the regulatory bodies with regard to the different networks covered by the freight corridor. (26) To facilitate access to information concerning the use of all the main infrastructure on the freight corridor and to guarantee non-discriminatory access to that corridor, the management board should draw up, regularly update and publish a document containing all of this information. (27) Since the objective of this Regulation, namely the establishment of a European rail network for competitive freight made up of freight corridors, cannot be sufficiently achieved by the Member States alone and can therefore by reason of its scale and effects be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (28) Fair rules based on cooperation between the infrastructure managers, who must provide a quality service to freight undertakings within the framework of an international rail corridor, should be introduced in respect of the coordination of investment and the management of capacities and traffic. (29) As international trains need to run itineraries combining several corridors, as defined in this Regulation, the infrastructure managers of several corridors may also coordinate their activities in order to ensure, on the corridors concerned, the availability of capacity, fluid movements and a coherent application of priority rules to the different types of traffic in the event of disturbance. (30) The aim of this Regulation is to improve the efficiency of rail freight transport relative to other modes of transport. Coordination should be ensured between Member States and infrastructure managers in order to guarantee the most efficient functioning of freight corridors. To allow this, operational measures should be taken in parallel with investments in infrastructure and in technical equipment such as ERTMS that should aim at increasing rail freight capacity and efficiency. (31) The implementation of the rules on the establishment and modification of the freight corridors and on the exemptions granted to the Member States needs to be achieved under uniform conditions in order to ensure the compliance of the proposals for the establishment of freight corridors with the criteria set out in this Regulation and should therefore be conferred upon the Commission. In accordance with Article 291 of the Treaty on the Functioning of the European Union, rules and general principles concerning mechanisms for the control by Member States of the Commission\u2019s exercise of implementing powers shall be laid down in advance by means of a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL Article 1 Purpose and scope 1. This Regulation lays down rules for the establishment and organisation of international rail corridors for competitive rail freight with a view to the development of a European rail network for competitive freight. It sets out rules for the selection, organisation, management and the indicative investment planning of freight corridors. 2. This Regulation shall apply to the management and use of railway infrastructure included in freight corridors. Article 2 Definitions 1. For the purposes of this Regulation, the definitions laid down in Article 2 of Directive 2001/14/EC shall apply. 2. In addition to the definitions referred to in paragraph 1: (a) \u2018freight corridor\u2019 means all designated railway lines, including railway ferry lines, on the territory of or between Member States, and, where appropriate, European third countries, linking two or more terminals, along a principal route and, where appropriate, diversionary routes and sections connecting them, including the railway infrastructure and its equipment and relevant rail services in accordance with Article 5 of Directive 2001/14/EC; (b) \u2018implementation plan\u2019 means the document presenting the means and the strategy that the parties concerned intend to implement in order to develop over a specified period the measures which are necessary and sufficient to establish the freight corridor; (c) \u2018terminal\u2019 means the installation provided along the freight corridor which has been specially arranged to allow either the loading and/or the unloading of goods onto/from freight trains, and the integration of rail freight services with road, maritime, river and air services, and either the forming or modification of the composition of freight trains; and, where necessary, performing border procedures at borders with European third countries. CHAPTER II DESIGNATION AND GOVERNANCE OF THE INTERNATIONAL RAIL CORRIDORS FOR COMPETITIVE FREIGHT Article 3 Designation of initial freight corridors The Member States referred to in the Annex shall make operational by the dates set out therein the initial freight corridors set out in the Annex. The Member States concerned shall inform the Commission about the establishment of the freight corridors. Article 4 Criteria for further freight corridors The selection of further freight corridors referred to in Article 5 and the modification of freight corridors referred to in Article 6 shall take account of the following criteria: (a) the crossing by the freight corridor of the territory of at least three Member States, or of two Member States if the distance between the terminals served by the freight corridor is greater than 500 km; (b) the consistency of the freight corridor with the TEN-T, the ERTMS corridors and/or the corridors defined by RNE; (c) the integration of TEN-T priority projects (7) into the freight corridor; (d) the balance between the socio-economic costs and benefits stemming from the establishment of the freight corridor; (e) the consistency of all of the freight corridors proposed by the Member States in order to set up a European rail network for competitive freight; (f) the development of rail freight traffic and major trade flows and goods traffic along the freight corridor; (g) if appropriate, better interconnections between Member States and European third countries; (h) the interest of the applicants in the freight corridor; (i) the existence of good interconnections with other modes of transport, in particular due to an adequate network of terminals, including in maritime and inland ports. Article 5 Selection of further freight corridors 1. Each Member State with a rail border with another Member State shall participate in the establishment of at least one freight corridor, unless this obligation has already been met under Article 3. 2. Notwithstanding paragraph 1, Member States shall, upon request from a Member State, participate in the establishment of the freight corridor as referred to in that paragraph or the prolongation of an existing corridor, in order to allow a neighbouring Member State to fulfil its obligation under that paragraph. 3. Without prejudice to the obligations of Member States under Article 7 of Directive 91/440/EEC, where a Member State considers, after having provided a socio-economic analysis, that the establishment of a freight corridor would not be in the interest of the applicants likely to use the freight corridor or would not bring significant socio-economic benefits or would cause a disproportionate burden, the Member State concerned shall not be obliged to participate as referred to in paragraphs 1 and 2 of this Article, subject to a decision of the Commission acting in accordance with the advisory procedure referred to in Article 21(2). 4. A Member State shall not be obliged to participate as referred to in paragraphs 1 and 2 if it has a rail network which has a track gauge which is different from that of the main rail network within the Union. 5. The establishment of a freight corridor shall be proposed by the Member States concerned. For this purpose they shall send jointly to the Commission a letter of intent including a proposal drawn up after consultation of the infrastructure managers and applicants concerned, taking into account the criteria set out in Article 4. In order to meet the obligation under paragraphs 1 and 2, the Member States concerned shall send jointly to the Commission a letter of intent by 10 November 2012. 6. The Commission shall examine the proposals for the establishment of a freight corridor as referred to in paragraph 5 and, in accordance with the regulatory procedure referred to in Article 21(3), adopt a decision on the compliance of such a proposal with this Article at the latest 9 months after submission of the proposal. 7. The Member States concerned shall establish the freight corridor at the latest two years after the decision of the Commission referred to in paragraph 6. Article 6 Modification of further freight corridors 1. The freight corridors referred to in Article 5 may be modified on the basis of a joint proposal by the Member States concerned to the Commission after consulting the infrastructure managers and applicants concerned. 2. The Commission shall, in accordance with the regulatory procedure referred to in Article 21(3), adopt a decision on the proposal taking into account the criteria set out in Article 4. Article 7 Reconciliation When two or more Member States concerned do not agree on the establishment or modification of a freight corridor, and with regard to the railway infrastructure located on their territory, the Commission, at the request of one of the Member States concerned, shall consult the Committee referred to in Article 21 on this matter. The opinion of the Commission shall be sent to the Member States concerned. The Member States concerned shall take this opinion into account in order to find a solution and shall take a decision on the basis of mutual consent. Article 8 Governance of freight corridors 1. For each freight corridor, Member States concerned shall establish an executive board responsible for defining the general objectives of the freight corridor, supervising and taking the measures as expressly provided for in paragraph 7 of this Article, and in Articles 9 and 11, Article 14(1) and Article 22. The executive board shall be composed of representatives of the authorities of the Member States concerned. 2. For each freight corridor, the infrastructure managers concerned and, where relevant, the allocation bodies as referred to in Article 14(2) of Directive 2001/14/EC, shall establish a management board responsible for taking the measures as expressly provided for in paragraphs 5, 7, 8 and 9 of this Article, and in Articles 9 to 12, Article 13(1), Article 14(2), (6) and (9), Article 16(1), Article 17(1) and Articles 18 and 19 of this Regulation. The management board shall be composed of the representatives of the infrastructure managers. 3. The Member States and infrastructure managers concerned by a freight corridor shall cooperate within the boards referred to in paragraphs 1 and 2 to ensure the development of the freight corridor in accordance with its implementation plan. 4. The executive board shall take its decisions on the basis of mutual consent of the representatives of the authorities of the Member States concerned. 5. The management board shall take its decisions, including decisions regarding its legal status, the establishment of its organisational structure, resources and staffing, on the basis of mutual consent of the infrastructure managers concerned. The management board may be an independent legal entity. It may take the form of a European economic interest grouping within the meaning of Council Regulation (EEC) No 2137/85 of 25 July 1985 on the European Economic Interest Grouping (EEIG) (8). 6. The responsibilities of the executive and management boards shall be without prejudice to the independence of infrastructure managers as provided for in Article 4(2) of Directive 91/440/EEC. 7. The management board shall set up an advisory group made up of managers and owners of the terminals of the freight corridor including, where necessary, sea and inland waterway ports. This advisory group may issue an opinion on any proposal by the management board which has direct consequences for investment and the management of terminals. It may also issue own-initiative opinions. The management board shall take any of these opinions into account. In the event of disagreement between the management board and the advisory group, the latter may refer the matter to the executive board. The executive board shall act as an intermediary and provide its opinion in due time. The final decision however shall be taken by the management board. 8. The management board shall set up a further advisory group made up of railway undertakings interested in the use of the freight corridor. This advisory group may issue an opinion on any proposal by the management board which has consequences for these undertakings. It may also issue own-initiative opinions. The management board shall take any of these opinions into account. 9. The management board shall coordinate in accordance with national and European deployment plans the use of interoperable IT applications or alternative solutions that may become available in the future to handle requests for international train paths and the operation of international traffic on the freight corridor. Article 9 Measures for implementing the freight corridor plan 1. The management board shall draw up an implementation plan at the latest 6 months before making the freight corridor operational and shall submit it for approval to the executive board. This plan shall include: (a) a description of the characteristics of the freight corridor, including bottlenecks, and the programme of measures necessary for creating the freight corridor; (b) the essential elements of the study referred to in paragraph 3; (c) the objectives for the freight corridors, in particular in terms of performance of the freight corridor expressed as the quality of the service and the capacity of the freight corridor in accordance with the provisions of Article 19; (d) the investment plan referred to in Article 11; and (e) the measures to implement the provisions of Articles 12 to 19. 2. The management board shall periodically review the implementation plan taking into account progress made in its implementation, the rail freight market on the freight corridor and performance measured in accordance with the objectives referred to in point (c) of paragraph 1. 3. The management board shall carry out and periodically update a transport market study relating to the observed and expected changes in the traffic on the freight corridor, as a consequence of its being established, covering the different types of traffic, both regarding the transport of freight and the transport of passengers. This study shall also review, where necessary, the socio-economic costs and benefits stemming from the establishment of the freight corridor. 4. The implementation plan shall take into account the development of terminals to meet the needs of rail freight running on the freight corridor, in particular by acting as intermodal nodes along the freight corridors. 5. The management board shall, as appropriate, take measures to cooperate with regional and/or local administrations in respect of the implementation plan. Article 10 Consulting applicants The management board shall introduce consultation mechanisms with a view to the proper participation of the applicants likely to use the freight corridor. In particular, it shall ensure that applicants are consulted before the implementation plan referred to in Article 9 is submitted to the executive board. CHAPTER III INVESTMENT IN THE FREIGHT CORRIDOR Article 11 Investment planning 1. The management board shall draw up and periodically review an investment plan, which includes details of indicative medium and long-term investment for infrastructure in the freight corridor, and shall submit it for approval to the executive board. This plan shall include: (a) the list of the projects foreseen for the extension, renewal or redeployment of railway infrastructure and its equipment along the freight corridor and the relevant financial requirements and sources of finance; (b) a deployment plan relating to the interoperable systems along the freight corridor which satisfies the essential requirements and the technical specifications for interoperability which apply to the network as defined in Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (9). This deployment plan shall be based on a cost-benefit analysis of the use of interoperable systems; (c) a plan for the management of the capacity of freight trains which may run on the freight corridor, which includes removing the identified bottlenecks. This plan may be based on improving speed management and on increasing the length, loading gauge, and load hauled or axle load authorised for the trains running on the freight corridor; and (d) where applicable, reference to the contribution of the Union envisaged under financial programmes of the Union. 2. The application of this Regulation shall be without prejudice to the competence of the Member States regarding planning of and funding for rail infrastructure. Article 12 Coordination of works The management board shall coordinate and ensure the publication in one place, in an appropriate manner and timeframe, of their schedule for carrying out all the works on the infrastructure and its equipment that would restrict available capacity on the freight corridor. CHAPTER IV MANAGEMENT OF THE FREIGHT CORRIDOR Article 13 One-stop shop for application for infrastructure capacity 1. The management board for a freight corridor shall designate or set up a joint body for applicants to request and to receive answers, in a single place and in a single operation, regarding infrastructure capacity for freight trains crossing at least one border along the freight corridor (hereinafter referred to as a \u2018one-stop shop\u2019). 2. The one-stop shop shall, as a coordination tool, also provide basic information concerning the allocation of the infrastructure capacity, including the information referred in Article 18. It shall display infrastructure capacity available at the time of request and its characteristics in accordance with pre-defined parameters, such as speed, length, loading gauge or axle load authorised for trains running on the freight corridor. 3. The one-stop shop shall take a decision with regard to applications for pre-arranged train paths specified in Article 14(3) and for the reserve capacity specified in Article 14(5). It shall allocate the capacity in line with rules regarding capacity allocation as set out in Directive 2001/14/EC. It shall inform the competent infrastructure managers of these applications and the decision taken without delay. 4. For any request of infrastructure capacity which cannot be met pursuant to paragraph 3, the one-stop shop shall forward the application for infrastructure capacity without any delay to the competent infrastructure managers and, where relevant, the allocation bodies as referred to in Article 14(2) of Directive 2001/14/EC, who shall take a decision on that application in accordance with Article 13 and Chapter III of that Directive and communicate this decision to the one-stop shop for further processing. 5. The activities of the one-stop shop shall be carried out in a transparent and non-discriminatory manner. To this end a register shall be kept which shall be made freely available to all interested parties. It shall contain the dates of the requests, names of the applicants, details of documentation supplied and of incidents which have occurred. These activities shall be subject to the control of the regulatory bodies in accordance with Article 20. Article 14 Capacity allocated to freight trains 1. The executive board shall define the framework for the allocation of the infrastructure capacity on the freight corridor in accordance with Article 14(1) of Directive 2001/14/EC. 2. The management board shall evaluate the need for capacity to be allocated to freight trains running on the freight corridor taking into account the transport market study referred to in Article 9(3) of this Regulation, the requests for infrastructure capacity relating to the past and present working timetables and the framework agreements. 3. On the basis of the evaluation specified in paragraph 2 of this Article, infrastructure managers of the freight corridor shall jointly define and organise international pre-arranged train paths for freight trains following the procedure referred to in Article 15 of Directive 2001/14/EC recognising the need for capacity of other types of transport, including passenger transport. They shall facilitate journey times, frequencies, times of departure and destination and routings suitable for freight transport services with a view to increasing the transport of goods by freight trains running on the freight corridor. These pre-arranged train paths shall be published not later than 3 months before the final date for receipt of requests for capacity referred to in Annex III to Directive 2001/14/EC. The infrastructure managers of several freight corridors may, if necessary, coordinate international prearranged train paths offering capacity on the freight corridors concerned. 4. These pre-arranged train paths shall be allocated first to freight trains which cross at least one border. 5. Infrastructure managers shall, if justified by market need and the evaluation as referred to in paragraph 2 of this Article, jointly define the reserve capacity for international freight trains running on the freight corridors recognising the need for capacity of other types of transport, including passenger transport and keep this reserve available within their final working timetables to allow for a quick and appropriate response to ad hoc requests for capacity as referred to in Article 23 of Directive 2001/14/EC. This capacity shall be reserved until the time limit before its scheduled time as decided by the management board. This time limit shall not exceed 60 days. 6. The management board shall promote coordination of priority rules relating to capacity allocation on the freight corridor. 7. Infrastructure managers may include in their conditions of use a fee for train paths that are allocated but ultimately not used. The level of this fee shall be appropriate, dissuasive and effective. 8. Save in the case of force majeure, including urgent and unforeseeable safety-critical work, a train path allocated to a freight operation pursuant to this Article may not be cancelled less than 2 months before its scheduled time in the working timetable if the applicant concerned does not give its approval for such cancellation. In such a case the infrastructure manager concerned shall make an effort to propose to the applicant a train path of an equivalent quality and reliability which the applicant has the right to accept or refuse. This provision shall be without prejudice to any rights the applicant may have under an agreement as referred to in Article 19(1) of Directive 2001/14/EC. In any case, the applicant may refer the matter to the regulatory body referred to in Article 20 of this Regulation. 9. The management board of the freight corridor and the advisory group referred to in Article 8(7) shall put in place procedures to ensure optimal coordination of the allocation of capacity between infrastructure managers, both for requests as referred to in Article 13(1) and for requests received by infrastructure managers concerned. This shall also take account of access to terminals. 10. In paragraphs 4 and 9 of this Article, references to infrastructure managers shall include, where relevant, allocation bodies as referred to in Article 14(2) of Directive 2001/14/EC. Article 15 Authorised applicants Notwithstanding Article 16(1) of Directive 2001/14/EC, applicants other than railway undertakings or the international groupings that they make up, such as shippers, freight forwarders and combined transport operators, may request international pre-arranged train paths specified in Article 14(3) and the reserve capacity specified in Article 14(5). In order to use such a train path for freight transport on the freight corridor these applicants shall appoint a railway undertaking to conclude an agreement with the infrastructure manager in accordance with Article 10(5) of Directive 91/440/EEC. Article 16 Traffic management 1. The management board of the freight corridor shall put in place procedures for coordinating traffic management along the freight corridor. The management boards of connected freight corridors shall put in place procedures for coordinating traffic along such freight corridors. 2. The infrastructure managers of the freight corridor and the advisory group referred to in Article 8(7) shall put in place procedures to ensure optimal coordination between the operation of the railway infrastructure and the terminals. Article 17 Traffic management in the event of disturbance 1. The management board shall adopt common targets for punctuality and/or guidelines for traffic management in the event of disturbance to train movements on the freight corridor. 2. Each infrastructure manager concerned shall draw up priority rules for the management between the different types of traffic in the part of the freight corridors within the responsibility of that infrastructure manager in accordance with the common targets and/or guidelines referred to in paragraph 1 of this Article. Those priority rules shall be published in the network statement referred to in Article 3 of Directive 2001/14/EC. 3. The principles for establishing the priority rules shall at least provide that the train path referred to in Article 14(3) and (4) allocated to freight trains which comply with their scheduled time in the working timetable shall not be modified, as far as possible. The principles for establishing the priority rules shall aim at minimising the overall network recovery time with regard to the needs of all types of transport. For this purpose, infrastructure managers may coordinate the management between the different types of traffic along several freight corridors. Article 18 Information on the conditions of use of the freight corridor The management board shall draw up, regularly update and publish a document containing: (a) all the information contained in the network statement for national networks regarding the freight corridor, drawn up in accordance with the procedure set out in Article 3 of Directive 2001/14/EC; (b) the list and characteristics of terminals, in particular information concerning the conditions and methods of accessing the terminals; (c) the information concerning the procedures referred to in Articles 13 to 17 of this Regulation; and (d) the implementation plan. Article 19 Quality of service on the freight corridor 1. The management board of the freight corridor shall promote compatibility between the performance schemes along the freight corridor, as referred to in Article 11 of Directive 2001/14/EC. 2. The management board shall monitor the performance of rail freight services on the freight corridor and publish the results of this monitoring once a year. 3. The management board shall organise a satisfaction survey of the users of the freight corridor and shall publish the results of it once a year. Article 20 Regulatory bodies 1. The regulatory bodies referred to in Article 30 of Directive 2001/14/EC shall cooperate in monitoring the competition in the rail freight corridor. In particular, they shall ensure non-discriminatory access to the corridor and shall be the appeal bodies provided for under Article 30(2) of that Directive. They shall exchange the necessary information obtained from infrastructure managers and other relevant parties. 2. Member States, in order to foster free and fair competition on the freight corridors, shall endeavour to establish a comparable regulatory level. Regulatory bodies shall be easily accessible to the market players, and shall be able to take decisions independently and efficiently. 3. In the event of a complaint to a regulatory body from an applicant regarding international rail freight services, or within the framework of an own-initiative investigation by a regulatory body, this regulatory body shall consult the regulatory bodies of all other Member States through which the international train path for freight train concerned runs and request all necessary information from them before taking its decision. 4. The regulatory bodies consulted under paragraph 3 shall provide all the information that they themselves have the right to request under their national legislation to the regulatory body concerned. This information may only be used for the purpose of the handling of the complaint or the investigation referred to in paragraph 3. 5. The regulatory body receiving the complaint or having initiated the own-initiative investigation shall transfer relevant information to the regulatory body responsible in order for that body to take measures regarding the parties concerned. 6. Any associated representatives of infrastructure managers as referred to in Article 15(1) of Directive 2001/14/EC shall ensure provision, without delay, of all the information necessary for the purpose of the handling of the complaint or the investigation referred to in paragraph 3 of this Article and requested by the regulatory body of the Member State in which the associated representative is located. This regulatory body shall be entitled to transfer such information regarding the international train path concerned to the regulatory bodies mentioned in paragraph 3 of this Article. CHAPTER V FINAL PROVISIONS Article 21 Committee procedure 1. The Commission shall be assisted by the Committee referred to in Article 11a of Directive 91/440/EEC. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months. Article 22 Monitoring implementation Every two years from the time of the establishment of a freight corridor, the executive board referred to in Article 8(1) shall present to the Commission the results of the implementation plan for that corridor. The Commission shall analyse those results and notify the Committee referred to in Article 21 of its analysis. Article 23 Report The Commission shall periodically examine the application of this Regulation. It shall submit a report to the European Parliament and the Council, for the first time by 10 November 2015, and every three years thereafter. Article 24 Transitional measures This Regulation shall not apply to the Republic of Cyprus and Malta for as long as no railway system is established within their territory. Article 25 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 22 September 2010. For the European Parliament The President J. BUZEK For the Council The President O. CHASTEL (1) OJ C 317, 23.12.2009, p. 94. (2) OJ C 79, 27.3.2010, p. 45. (3) Position of the European Parliament of 23 April 2009 (OJ C 184 E, 8.7.2010, p. 354), position of the Council at first reading of 22 February 2010 (OJ C 114 E, 4.5.2010, p. 1), position of the European Parliament of 15 June 2010 (not yet published in the Official Journal) and decision of the Council of 13 September 2010. (4) OJ L 237, 24.8.1991, p. 25. (5) OJ L 75, 15.3.2001, p. 29. (6) OJ L 184, 17.7.1999, p. 23. (7) See Annex III to Decision No 661/2010/EU of the European Parliament and of the Council of 7 July 2010 on Union guidelines for the development of the trans-European transport network (OJ L 204, 5.8.2010, p. 1). (8) OJ L 199, 31.7.1985, p. 1. (9) OJ L 191, 18.7.2008, p. 1. ANNEX List of initial freight corridors Member States Principal routes (1) Establishment of freight corridors: 1. NL, BE, DE, IT Zeebrugge-Antwerp/Rotterdam-Duisburg-[Basel]-Milan-Genoa By 10 November 2013 2. NL, BE, LU, FR Rotterdam-Antwerp-Luxembourg-Metz-Dijon-Lyon/[Basel] By 10 November 2013 3. SE, DK, DE, AT, IT Stockholm-Malm\u00f6-Copenhagen-Hamburg-Innsbruck-Verona-Palermo By 10 November 2015 4. PT, ES, FR Sines-Lisbon/Leix\u00f5es \u2014 Madrid-Medina del Campo/Bilbao/San Sebastian-Irun-Bordeaux-Paris/Le Havre/Metz Sines-Elvas/Algeciras By 10 November 2013 5. PL, CZ, SK, AT, IT, SI Gdynia-Katowice-Ostrava/\u017dilina-Bratislava/Vienna/Klagenfurt-Udine-Venice/ Trieste/ /Bologna/Ravenna/ Graz-Maribor-Ljubljana-Koper/Trieste By 10 November 2015 6. ES, FR, IT, SI, HU Almer\u00eda-Valencia/Madrid-Zaragoza/Barcelona-Marseille-Lyon-Turin-Milan-Verona-Padua/Venice-Trieste/Koper-Ljubljana-Budapest-Zahony (Hungarian-Ukrainian border) By 10 November 2013 7. CZ, AT, SK, HU, RO, BG, EL \u2014 Bucharest-Constanta Prague-Vienna/Bratislava-Budapest \u2014 Vidin-Sofia-Thessaloniki-Athens By 10 November 2013 8. DE, NL, BE, PL, LT Bremerhaven/Rotterdam/Antwerp-Aachen/Berlin-Warsaw-Terespol (Poland-Belarus border)/Kaunas By 10 November 2015 9. CZ, SK Prague-Horn\u00ed Lide\u010d-\u017dilina-Ko\u0161ice-\u010cierna nad Tisou (Slovak/Ukrainian border) By 10 November 2013 (1) \u2018/\u2019 means alternative routes. In line with the TEN-T priority projects, routes 4 and 6 should in the future be completed by Project 16, the Sines/Algeciras-Madrid-Paris freight axis which takes in the central Pyrenees crossing via a low elevation tunnel.", "summary": "A European rail network for competitive freight A European rail network for competitive freight This regulation sets out rules for the establishment and organisation of international rail corridors for competitive rail freight in order to develop a European rail network for competitive freight. ACT Regulation (EU) No 913/2010 of the European Parliament and of the Council of 22 September 2010 concerning a European rail network for competitive freight. SUMMARY This regulation aims to develop a European rail network for competitive freight by establishing rules for the creation and organisation of international rail corridors for competitive rail freight. The annex to this regulation, as amended by Regulation (EU) No 1316/2013, sets out 9 initial freight corridors which must be made operational by the concerned European Union (EU) countries by November 2013, November 2015 or November 2020. For each freight corridor, EU countries must establish an executive board, made up of representatives of the EU countries\u2019 authorities. For each freight corridor, the infrastructure managers concerned must establish a management board, made up of representatives of the infrastructure managers. This management board shall draw up an implementation plan which includes an investment plan, the measures foreseen to implement the corridor and the main elements of a market study. It will also set up an advisory group composed of managers and owners of the terminals of the freight corridor and another advisory group composed of railway undertakings interested in the use of the freight corridor. The management board shall jointly define and arrange international prearranged train paths for freight trains to offer journey times corresponding to the needs of the freight operators. The management board will establish or designate a joint body to provide authorised applicants with a single place to both request and receive answers relating to infrastructure capacity for freight trains crossing at least one border along the freight corridor. This one-stop shop will take decisions regarding applications for pre-arranged train paths and the reserve capacity for international freight trains. Any applications which cannot be met by the one-stop shop will be forwarded to the competent infrastructure managers, who will take a decision on the application and communicate this decision to the one-stop shop for further processing. Priority rules between the different types of traffic shall be drawn up for the cases of traffic disturbances. A document containing all the relevant information concerning the use of the corridor shall be published. Regulatory bodies shall cooperate and exchange information, notably in case of complaints. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 913/2010 9.11.2010 - OJ L 276 of 20.10.2010 Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 1316/2013 21.12.2013 - OJ L 348 of 20.12.2013 Last updated: 19.05.2014"}
{"article": "14.11.2009 EN Official Journal of the European Union L 300/51 REGULATION (EC) No 1071/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the European Data Protection Supervisor (2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) The completion of an internal market in road transport with fair conditions of competition requires the uniform application of common rules on admission to the occupation of road haulage operator or road passenger transport operator (the occupation of road transport operator). Such common rules will contribute to the achievement of a higher level of professional qualification for road transport operators, the rationalisation of the market and an improved quality of service, in the interests of road transport operators, their customers and the economy as a whole, together with improvements in road safety. They will also facilitate the effective exercise of the right of establishment by road transport operators. (2) Council Directive 96/26/EC of 29 April 1996 on admission to the occupation of road haulage operator and road passenger transport operator and mutual recognition of diplomas, certificates and other evidence of formal qualifications intended to facilitate for these operators the right to freedom of establishment in national and international transport operations (4) lays down minimum conditions governing admission to the occupation of road transport operator and the mutual recognition of the documents required in this connection. However, experience, an impact assessment and various studies show that that Directive is being applied inconsistently by Member States. Such disparities have several adverse consequences, in particular a distortion of competition and a lack of market transparency and of uniform monitoring, as well as the risk that undertakings employing staff with a low level of professional qualification may be negligent in respect of, or less compliant with, the rules on road safety and social welfare, which may harm the image of the sector. (3) These consequences are all the more detrimental as they are liable to disturb the smooth functioning of the internal market in road transport, since the market in the transport of international goods and certain cabotage operations is accessible to undertakings throughout the Community. The only condition imposed on such undertakings is that they have a Community licence, which can be obtained provided they satisfy the conditions governing admission to the occupation of road transport operator laid down in Regulation (EC) No 1072/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international road haulage market (5) and Regulation (EC) No 1073/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international market for coach and bus services (6). (4) It is therefore appropriate to modernise the existing rules on admission to the occupation of road transport operator in order to ensure that those rules are applied more uniformly and effectively. Since compliance with those rules constitutes the main condition governing access to the Community market, and the applicable Community instruments in this field are Regulations, a Regulation would appear to be the most appropriate instrument to govern admission to the occupation of road transport operator. (5) Member States should be allowed to adapt the conditions with which to comply in order to pursue the occupation of road transport operator in the outermost regions referred to in Article 299(2) of the Treaty because of the special characteristics of, and constraints in, those regions. However, the undertakings established in those regions which comply with the conditions to pursue the occupation of road transport operator only as a result of such adaptation should not be able to obtain a Community licence. The adaptation of the conditions to pursue the occupation of road transport operator should not hinder undertakings which would have been admitted to the occupation of road transport operator and which comply with the general conditions laid down in this Regulation from carrying out transport operations in the outermost regions. (6) In the interests of fair competition, the common rules governing the exercise of the occupation of road transport operator should apply as widely as possible to all undertakings. However, it is unnecessary to include within the scope of this Regulation undertakings which only perform transport operations with a very small impact on the transport market. (7) It should be the responsibility of the Member State of establishment to verify that an undertaking satisfies at all times the conditions laid down in this Regulation so that the competent authorities of that Member State are able, if necessary, to decide to suspend or withdraw the authorisations which allow that undertaking to operate on the market. Proper compliance with, and reliable monitoring of, the conditions governing admission to the occupation of road transport operator presuppose that undertakings have an effective and stable establishment. (8) Natural persons with the requisite good repute and professional competence should be clearly identified and designated to the competent authorities. Such persons (transport managers), should be resident in a Member State and effectively and continuously manage the transport activities of road transport undertakings. It is therefore appropriate to specify the conditions under which a person is considered to effectively and continuously manage the transport activities of an undertaking. (9) The good repute of transport managers is conditional on their not having been convicted of a serious criminal offence or not having incurred a penalty, for a serious infringement, in particular, of Community rules relating to road transport. A conviction or penalty incurred by a transport manager or a road transport undertaking in one or more Member States for the most serious infringements of Community rules should result in the loss of good repute provided that the competent authority has ascertained that a duly completed and documented investigation procedure granting essential procedural rights took place before its final decision and that appropriate rights of appeal were respected. (10) It is necessary for road transport undertakings to have a minimum financial standing to ensure their proper launching and administration. A bank guarantee or a professional liability insurance may constitute a simple and cost-efficient method of demonstrating the financial standing of undertakings. (11) A high level of professional qualification should increase the socioeconomic efficiency of the road transport sector. It is therefore appropriate that applicants for the post of transport manager should possess high-quality professional knowledge. In order to ensure greater uniformity of examinations and to promote a high quality of training, it is appropriate to provide that Member States may authorise examination and training centres according to criteria to be defined by them. Transport managers should possess the requisite knowledge for managing both national and international transport operations. The list of subjects of which knowledge is required in order to obtain a certificate of professional competence and the procedures for the organisation of examinations are likely to evolve with technical progress, and provision should be made for updating them. It should be possible for Member States to exempt from the examinations persons who can provide proof of continuous experience in managing transport activities. (12) Fair competition and road transport that is fully compliant with the rules call for a uniform level of monitoring by Member States. The national authorities responsible for monitoring undertakings and the validity of their authorisations have a crucial role to play in this respect, and it is appropriate to ensure that they take suitable measures if necessary, in particular in the most serious cases by suspending or withdrawing authorisations or declaring as unsuitable transport managers who are repeatedly negligent or who act in bad faith. This must be preceded by due consideration of the measure with respect to the proportionality principle. An undertaking should, however, be warned in advance and should have a reasonable period of time within which to rectify the situation before incurring such penalties. (13) Better organised administrative cooperation between Member States would improve the effectiveness of the monitoring of undertakings operating in several Member States and would reduce administrative costs in the future. Electronic registers of undertakings interconnected throughout the Community, which comply with the Community rules on the protection of personal data, would facilitate such cooperation and reduce the costs involved in checks for both undertakings and administrations. National registers already exist in several Member States. Infrastructure has also been set up with a view to promoting interconnection between Member States. A more systematic use of electronic registers could therefore make a significant contribution to reducing the administrative costs of checks and to improving their effectiveness. (14) Some data contained in national electronic registers concerning infringements and penalties are personal. Member States should therefore take the measures necessary to ensure compliance with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (7), in particular with regard to the monitoring of the processing of personal data by public authorities, the right of data subjects to be provided with information, their right of access and their right to object. For the purposes of this Regulation, it would appear to be necessary to retain such data for at least 2 years to ensure that disqualified undertakings do not establish themselves in other Member States. (15) In order to improve transparency and to allow the client of a transport undertaking to verify whether that undertaking is in possession of the appropriate authorisation, certain data contained in the national electronic register should be made publicly accessible, in so far as the relevant provisions on data protection are complied with. (16) It is essential to gradually interconnect national electronic registers so as to enable information to be exchanged rapidly and efficiently between Member States and to guarantee that road transport operators are not tempted to commit, or to take the risk of committing, serious infringements in Member States other than their Member State of establishment. Interconnection of this kind entails the joint definition of the precise format of the data to be exchanged and the technical procedures for the exchange of that data. (17) In order to ensure the efficient exchange of information between Member States, national contact points should be designated and certain common procedures relating as a minimum to time limits and the nature of the information to be forwarded, should be specified. (18) In order to facilitate freedom of establishment, the production of appropriate documents issued by a competent authority in the Member State where the transport manager used to reside should be accepted as sufficient proof of good repute for admission to the occupation of road transport operator in the Member State of establishment, provided that the persons concerned have not been declared unfit to pursue that occupation in other Member States. (19) With regard to professional competence, in order to facilitate freedom of establishment, a single model certificate issued in accordance with this Regulation should be regarded as sufficient proof by the Member State of establishment. (20) Closer monitoring of the application of this Regulation at Community level is required. This presupposes the forwarding to the Commission of regular reports, drawn up on the basis of national registers, on the good repute, financial standing and professional competence of undertakings in the road transport sector. (21) Member States should provide for penalties applicable to infringements of this Regulation. Such penalties should be effective, proportionate and dissuasive. (22) Since the objective of this Regulation, namely the modernisation of the rules governing admission to the occupation of road transport operator in order to ensure that those rules are applied more uniformly and effectively in the Member States, cannot be sufficiently achieved by the Member States and can therefore by reason of the scale and effects of the action be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (23) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8). (24) In particular, the Commission should be empowered to draw up a list of categories, types and degrees of seriousness of infringements leading to the loss of good repute of road transport operators, to adapt to technical progress Annexes I, II and III to this Regulation concerning the knowledge to be taken into consideration for the recognition of professional competence by the Member States and the model certificate of professional competence, and to draw up a list of infringements which in addition to those set out in Annex IV to this Regulation may lead to the loss of good repute. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (25) Directive 96/26/EC should be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation governs admission to, and the pursuit of, the occupation of road transport operator. 2. This Regulation shall apply to all undertakings established in the Community which are engaged in the occupation of road transport operator. It shall also apply to undertakings which intend to engage in the occupation of road transport operator. References to undertakings engaged in the occupation of road transport operator shall, as appropriate, be considered to include a reference to undertakings intending to engage in such occupation. 3. As regards the regions referred to in Article 299(2) of the Treaty, the Member States concerned may adapt the conditions to be complied with in order to pursue the occupation of road transport operator, in so far as operations are fully carried out in those regions by undertakings established there. 4. By way of derogation from paragraph 2, this Regulation shall, unless otherwise provided for in national law, not apply to: (a) undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles or combinations of vehicles the permissible laden mass of which does not exceed 3,5 tonnes. Member States may, however, lower this limit for all or some categories of road transport operations; (b) undertakings engaged in road passenger transport services exclusively for non-commercial purposes or which have a main occupation other than that of road passenger transport operator; (c) undertakings engaged in the occupation of road transport operator solely by means of motor vehicles with a maximum authorised speed not exceeding 40 km/h. 5. Member States may exempt from the application of all or some of the provisions of this Regulation only those road transport operators engaged exclusively in national transport operations having only a minor impact on the transport market because of: (a) the nature of the goods carried; or (b) the short distances involved. Article 2 Definitions For the purposes of this Regulation: 1. \u2018the occupation of road haulage operator\u2019 means the activity of any undertaking transporting goods for hire or reward by means either of motor vehicles or combinations of vehicles; 2. \u2018the occupation of road passenger transport operator\u2019 means the activity of any undertaking operating, by means of motor vehicles so constructed and equipped as to be suitable for carrying more than nine persons, including the driver, and intended for that purpose, passenger transport services for the public or for specific categories of users in return for payment by the person transported or by the transport organiser; 3. \u2018the occupation of road transport operator\u2019 means the occupation of road passenger transport operator or the occupation of road haulage operator; 4. \u2018undertaking\u2019 means any natural person, any legal person, whether profit-making or not, any association or group of persons without legal personality, whether profit-making or not, or any official body, whether having its own legal personality or being dependent upon an authority having such personality, engaged in the transport of passengers, or any natural or legal person engaged in the transport of freight with a commercial purpose; 5. \u2018transport manager\u2019 means a natural person employed by an undertaking or, if that undertaking is a natural person, that person or, where provided for, another natural person designated by that undertaking by means of a contract, who effectively and continuously manages the transport activities of that undertaking; 6. \u2018authorisation to pursue the occupation of road transport operator\u2019 means an administrative decision which authorises an undertaking which satisfies the conditions laid down in this Regulation to pursue the occupation of road transport operator; 7. \u2018competent authority\u2019 means a national, regional or local authority in a Member State which, for the purpose of authorising the pursuit of the occupation of road transport operator, verifies whether an undertaking satisfies the conditions laid down in this Regulation, and which is empowered to grant, suspend or withdraw an authorisation to pursue the occupation of road transport operator; 8. \u2018Member State of establishment\u2019 means the Member State in which an undertaking is established, regardless of whether its transport manager originates from another country. Article 3 Requirements for engagement in the occupation of road transport operator 1. Undertakings engaged in the occupation of road transport operator shall: (a) have an effective and stable establishment in a Member State; (b) be of good repute; (c) have appropriate financial standing; and (d) have the requisite professional competence. 2. Member States may decide to impose additional requirements, which shall be proportionate and non-discriminatory, to be satisfied by undertakings in order to engage in the occupation of road transport operator. Article 4 Transport manager 1. An undertaking which engages in the occupation of road transport operator shall designate at least one natural person, the transport manager, who satisfies the requirements set out in Article 3(1)(b) and (d) and who: (a) effectively and continuously manages the transport activities of the undertaking; (b) has a genuine link to the undertaking, such as being an employee, director, owner or shareholder or administering it, or, if the undertaking is a natural person, is that person; and (c) is resident in the Community. 2. If an undertaking does not satisfy the requirement of professional competence laid down in Article 3(1)(d), the competent authority may authorise it to engage in the occupation of road transport operator without a transport manager designated in accordance with paragraph 1 of this Article, provided that: (a) the undertaking designates a natural person residing in the Community who satisfies the requirements laid down in Article 3(1)(b) and (d), and who is entitled under contract to carry out duties as transport manager on behalf of the undertaking; (b) the contract linking the undertaking with the person referred to in point (a) specifies the tasks to be performed on an effective and continuous basis by that person, and indicates his or her responsibilities as transport manager. The tasks to be specified shall comprise, in particular, those relating to vehicle maintenance management, verification of transport contracts and documents, basic accounting, the assignment of loads or services to drivers and vehicles, and the verification of safety procedures; (c) in his or her capacity as transport manager, the person referred to in point (a) may manage the transport activities of up to four different undertakings carried out with a combined maximum total fleet of 50 vehicles. Member States may decide to lower the number of undertakings and/or the size of the total fleet of vehicles which that person may manage; and (d) the person referred to in point (a) performs the specified tasks solely in the interests of the undertaking and his or her responsibilities are exercised independently of any undertakings for which the undertaking carries out transport operations. 3. Member States may decide that a transport manager designated in accordance with paragraph 1 may not in addition be designated in accordance with paragraph 2, or may only be so designated in respect of a limited number of undertakings or a fleet of vehicles that is smaller than that referred to in paragraph 2(c). 4. The undertaking shall notify the competent authority of the transport manager or managers designated. CHAPTER II CONDITIONS TO BE MET TO SATISFY THE REQUIREMENTS LAID DOWN IN ARTICLE 3 Article 5 Conditions relating to the requirement of establishment In order to satisfy the requirement laid down in Article 3(1)(a), an undertaking shall, in the Member State concerned: (a) have an establishment situated in that Member State with premises in which it keeps its core business documents, in particular its accounting documents, personnel management documents, documents containing data relating to driving time and rest and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this Regulation. Member States may require that establishments on their territory also have other documents available at their premises at any time; (b) once an authorisation is granted, have at its disposal one or more vehicles which are registered or otherwise put into circulation in conformity with the legislation of that Member State, whether those vehicles are wholly owned or, for example, held under a hire-purchase agreement or a hire or leasing contract; (c) conduct effectively and continuously with the necessary administrative equipment its operations concerning the vehicles mentioned in point (b) and with the appropriate technical equipment and facilities at an operating centre situated in that Member State. Article 6 Conditions relating to the requirement of good repute 1. Subject to paragraph 2 of this Article, Member States shall determine the conditions to be met by undertakings and transport managers in order to satisfy the requirement of good repute laid down in Article 3(1)(b). In determining whether an undertaking has satisfied that requirement, Member States shall consider the conduct of the undertaking, its transport managers and any other relevant person as may be determined by the Member State. Any reference in this Article to convictions, penalties or infringements shall include convictions, penalties or infringements of the undertaking itself, its transport managers and any other relevant person as may be determined by the Member State. The conditions referred to in the first subparagraph shall include at least the following: (a) that there be no compelling grounds for doubting the good repute of the transport manager or the transport undertaking, such as convictions or penalties for any serious infringement of national rules in force in the fields of: (i) commercial law; (ii) insolvency law; (iii) pay and employment conditions in the profession; (iv) road traffic; (v) professional liability; (vi) trafficking in human beings or drugs; and (b) that the transport manager or the transport undertaking have not in one or more Member States been convicted of a serious criminal offence or incurred a penalty for a serious infringement of Community rules relating in particular to: (i) the driving time and rest periods of drivers, working time and the installation and use of recording equipment; (ii) the maximum weights and dimensions of commercial vehicles used in international traffic; (iii) the initial qualification and continuous training of drivers; (iv) the roadworthiness of commercial vehicles, including the compulsory technical inspection of motor vehicles; (v) access to the market in international road haulage or, as appropriate, access to the market in road passenger transport; (vi) safety in the carriage of dangerous goods by road; (vii) the installation and use of speed-limiting devices in certain categories of vehicle; (viii) driving licences; (ix) admission to the occupation; (x) animal transport. 2. For the purposes of point (b) of the third subparagraph of paragraph 1: (a) where the transport manager or the transport undertaking has in one or more Member States been convicted of a serious criminal offence or incurred a penalty for one of the most serious infringements of Community rules as set out in Annex IV, the competent authority of the Member State of establishment shall carry out in an appropriate and timely manner a duly completed administrative procedure, which shall include, if appropriate, a check at the premises of the undertaking concerned. The procedure shall determine whether, due to specific circumstances, the loss of good repute would constitute a disproportionate response in the individual case. Any such finding shall be duly reasoned and justified. If the competent authority finds that the loss of good repute would constitute a disproportionate response, it may decide that good repute is unaffected. In such case, the reasons shall be recorded in the national register. The number of such decisions shall be indicated in the report referred to in Article 26(1). If the competent authority does not find that the loss of good repute would constitute a disproportionate response, the conviction or penalty shall lead to the loss of good repute; (b) the Commission shall draw up a list of categories, types and degrees of seriousness of serious infringements of Community rules which, in addition to those set out in Annex IV, may lead to the loss of good repute. Member States shall take into account information on those infringements, including information received from other Member States, when setting the priorities for checks pursuant to Article 12(1). Those measures, designed to amend non-essential elements of this Regulation by supplementing it and which relate to this list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). To this end, the Commission shall: (i) lay down the categories and types of infringement which are most frequently encountered; (ii) define the degree of seriousness of infringements according to their potential to create a risk of fatalities or serious injuries; and (iii) provide the frequency of occurrence beyond which repeated infringements shall be regarded as more serious, by taking into account the number of drivers used for the transport activities managed by the transport manager. 3. The requirement laid down in Article 3(1)(b) shall not be satisfied until a rehabilitation measure or any other measure having an equivalent effect has been taken pursuant to the relevant provisions of national law. Article 7 Conditions relating to the requirement of financial standing 1. In order to satisfy the requirement laid down in Article 3(1)(c), an undertaking shall at all times be able to meet its financial obligations in the course of the annual accounting year. To this end, the undertaking shall demonstrate, on the basis of annual accounts certified by an auditor or a duly accredited person, that, every year, it has at its disposal capital and reserves totalling at least EUR 9 000 when only one vehicle is used and EUR 5 000 for each additional vehicle used. For the purposes of this Regulation, the value of the euro in the currencies of Member States which do not participate in the third stage of the economic and monetary union shall be fixed every year. The rates to be applied shall be those obtained on the first working day of October and published in the Official Journal of the European Union. They shall have effect from 1 January of the following calendar year. The accounting items referred to in the first subparagraph shall be understood as those defined in Fourth Council Directive 78/660/EEC of 25 July 1978 based on Article 54(3)(g) of the Treaty on the annual accounts of certain types of companies (9). 2. By way of derogation from paragraph 1, the competent authority may agree or require that an undertaking demonstrate its financial standing by means of a certificate such as a bank guarantee or an insurance, including a professional liability insurance from one or more banks or other financial institutions, including insurance companies, providing a joint and several guarantee for the undertaking in respect of the amounts specified in the first subparagraph of paragraph 1. 3. The annual accounts referred to in paragraph 1, and the guarantee referred to in paragraph 2, which are to be verified, are those of the economic entity established in the Member State in which an authorisation has been applied for and not those of any other entity established in any other Member State. Article 8 Conditions relating to the requirement of professional competence 1. In order to satisfy the requirement laid down in Article 3(1)(d), the person or persons concerned shall possess knowledge corresponding to the level provided for in Part I of Annex I in the subjects listed therein. That knowledge shall be demonstrated by means of a compulsory written examination which, if a Member State so decides, may be supplemented by an oral examination. Those examinations shall be organised in accordance with Part II of Annex I. To this end, Member States may decide to impose training prior to the examination. 2. The persons concerned shall sit the examination in the Member State in which they have their normal residence or the Member State in which they work. \u2018Normal residence\u2019 shall mean the place where a person usually lives, that is for at least 185 days in each calendar year, because of personal ties which show close links between that person and the place where he is living. However, the normal residence of a person whose occupational ties are in a different place from his personal ties and who, consequently, lives in turn in different places situated in two or more Member States, shall be regarded as being in the place of his personal ties, provided that such person returns there regularly. This last condition shall not be required where the person is living in a Member State in order to carry out a task of a definite duration. Attendance at a university or school shall not imply transfer of normal residence. 3. Only the authorities or bodies duly authorised for this purpose by a Member State, in accordance with criteria defined by it, may organise and certify the written and oral examinations referred to in paragraph 1. Member States shall regularly verify that the conditions under which those authorities or bodies organise the examinations are in accordance with Annex I. 4. Member States may duly authorise, in accordance with criteria defined by them, bodies to provide applicants with high-quality training to prepare them for the examinations and transport managers with continuous training to update their knowledge if they wish to do so. Such Member States shall regularly verify that these bodies at all times fulfil the criteria on the basis of which they were authorised. 5. Member States may promote periodic training on the subjects listed in Annex I at 10-year intervals to ensure that transport managers are aware of developments in the sector. 6. Member States may require persons who possess a certificate of professional competence, but who have not managed a road haulage undertaking or a road passenger transport undertaking in the last 5 years, to undertake retraining in order to update their knowledge regarding the current developments of the legislation referred to in Part I of Annex I. 7. A Member State may exempt the holders of certain higher education qualifications or technical education qualifications issued in that Member State, specifically designated to this end and entailing knowledge of all the subjects listed in Annex I from the examination in the subjects covered by those qualifications. The exemption shall only apply to those sections of Part I of Annex I for which the qualification covers all subjects listed under the heading of each section. A Member State may exempt from specified parts of the examinations holders of certificates of professional competence valid for national transport operations in that Member State. 8. A certificate issued by the authority or body referred to in paragraph 3 shall be produced as proof of professional competence. That certificate shall not be transferable to any other person. It shall be drawn up in accordance with the security features and the model certificate set out in Annexes II and III and shall bear the seal of the duly authorised authority or body which issued it. 9. The Commission shall adapt Annexes I, II and III to technical progress. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 10. The Commission shall encourage and facilitate the exchange of experience and information between Member States, or through any body it may designate, concerning training, examinations and authorisations. Article 9 Exemption from examination Member States may decide to exempt from the examinations referred to in Article 8(1) persons who provide proof that they have continuously managed a road haulage undertaking or a road passenger transport undertaking in one or more Member States for the period of 10 years before 4 December 2009. CHAPTER III AUTHORISATION AND MONITORING Article 10 Competent authorities 1. Each Member State shall designate one or more competent authorities to ensure the correct implementation of this Regulation. Those competent authorities shall be empowered to: (a) examine applications made by undertakings; (b) grant authorisations to engage in the occupation of road transport operator, and suspend or withdraw such authorisations; (c) declare a natural person to be unfit to manage the transport activities of an undertaking in the capacity of transport manager; (d) carry out the requisite checks to verify whether an undertaking satisfies the requirements laid down in Article 3. 2. The competent authorities shall publish all the conditions laid down pursuant to this Regulation, any other national provisions, the procedures to be followed by interested applicants and the corresponding explanations. Article 11 Examination and registration of applications 1. A transport undertaking which complies with the requirements laid down in Article 3 shall, upon application, be authorised to engage in the occupation of road transport operator. The competent authority shall ascertain that an undertaking which submits an application satisfies the requirements laid down in that Article. 2. The competent authority shall record in the national electronic register referred to in Article 16 the data relating to undertakings which it authorises and which are referred to in points (a) to (d) of the first subparagraph of Article 16(2). 3. The time limit for the examination of an application for authorisation by a competent authority shall be as short as possible and shall not exceed 3 months from the date on which the competent authority receives all documents necessary to assess the application. The competent authority may extend this time limit for one additional month in duly justified cases. 4. Until 31 December 2012, the competent authority shall verify, in case of any doubt when assessing the good repute of an undertaking, whether at the time of application the designated transport manager or managers are declared, in one of the Member States, unfit to manage the transport activities of an undertaking pursuant to Article 14. From 1 January 2013, when assessing the good repute of an undertaking, the competent authority shall verify, by accessing the data referred to in point (f) of the first subparagraph of Article 16(2), either by direct secure access to the relevant part of the national registers or by request, whether at the time of the application the designated transport manager or managers are declared, in one of the Member States, unfit to manage the transport activities of an undertaking pursuant to Article 14. Measures designed to amend non-essential elements of this Regulation and relating to a postponement for a maximum of 3 years of the dates referred to in this paragraph shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 5. Undertakings with an authorisation to engage in the occupation of road transport operator shall, within a period of 28 days or less, as determined by the Member State of establishment, notify the competent authority which granted the authorisation of any changes to the data referred to in paragraph 2. Article 12 Checks 1. Competent authorities shall monitor whether undertakings which they have authorised to engage in the occupation of road transport operator continue to fulfil the requirements laid down in Article 3. To that end, Member States shall carry out checks targeting those undertakings which are classed as posing an increased risk. For that purpose, Member States shall extend the risk classification system established by them pursuant to Article 9 of Directive 2006/22/EC of the European Parliament and of the Council of 15 March 2006 on minimum conditions for the implementation of Council Regulations (EEC) No 3820/85 and (EEC) No 3821/85 concerning social legislation relating to road transport activities (10) to cover all infringements specified in Article 6 of this Regulation. 2. Until 31 December 2014, Member States shall carry out checks at least every 5 years to verify that undertakings fulfil the requirements laid down in Article 3. Measures designed to amend non-essential elements of this Regulation and relating to a postponement of the date referred to in the first subparagraph shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). 3. Member States shall carry out individual checks to verify whether an undertaking meets the conditions governing admission to the occupation of road transport operator whenever the Commission so requests in duly motivated cases. It shall inform the Commission of the results of such checks and of the measures taken if it is established that the undertaking no longer fulfils the requirements laid down in this Regulation. Article 13 Procedure for the suspension and withdrawal of authorisations 1. Where a competent authority establishes that an undertaking runs the risk of no longer fulfilling the requirements laid down in Article 3, it shall notify the undertaking thereof. Where a competent authority establishes that one or more of those requirements is no longer satisfied, it may set one of the following time limits for the undertaking to rectify the situation: (a) a time limit not exceeding 6 months, which may be extended by 3 months in the event of the death or physical incapacity of the transport manager, for the recruitment of a replacement transport manager where the transport manager no longer satisfies the requirement as to good repute or professional competence; (b) a time limit not exceeding 6 months where the undertaking has to rectify the situation by demonstrating that it has an effective and stable establishment; (c) a time limit not exceeding 6 months where the requirement of financial standing is not satisfied, in order to demonstrate that that requirement will again be satisfied on a permanent basis. 2. The competent authority may require an undertaking whose authorisation has been suspended or withdrawn to ensure that its transport managers have passed the examinations referred to in Article 8(1) prior to any rehabilitation measure being taken. 3. If the competent authority establishes that the undertaking no longer satisfies one or more of the requirements laid down in Article 3, it shall suspend or withdraw the authorisation to engage in the occupation of road transport operator within the time limits referred to in paragraph 1 of this Article. Article 14 Declaration of unfitness of the transport manager 1. Where a transport manager loses good repute in accordance with Article 6, the competent authority shall declare that transport manager unfit to manage the transport activities of an undertaking. 2. Unless and until a rehabilitation measure is taken in accordance with the relevant provisions of national law, the certificate of professional competence, referred to in Article 8(8), of the transport manager declared to be unfit, shall no longer be valid in any Member State. Article 15 Decisions of the competent authorities and appeals 1. Negative decisions taken by the competent authorities of the Member States pursuant to this Regulation, including the rejection of an application, the suspension or withdrawal of an existing authorisation and a declaration of unfitness of a transport manager, shall state the reasons on which they are based. Such decisions shall take account of available information concerning infringements committed by the undertaking or the transport manager which are such as to detract from the good repute of the undertaking and of any other information at the disposal of the competent authority. They shall specify the rehabilitation measures applicable in the event of the suspension of an authorisation or a declaration of unfitness. 2. Member States shall take steps to ensure that the undertakings and persons concerned have the possibility of appealing the decisions referred to in paragraph 1 to at least one independent and impartial body or a court of law. CHAPTER IV SIMPLIFICATION AND ADMINISTRATIVE COOPERATION Article 16 National electronic registers 1. For the purposes of the implementation of this Regulation, and in particular Articles 11 to 14 and Article 26 thereof, each Member State shall keep a national electronic register of road transport undertakings which have been authorised by a competent authority designated by it to engage in the occupation of road transport operator. The data contained in that register shall be processed under the supervision of a public authority designated for that purpose. The relevant data contained in the national electronic register shall be accessible to all the competent authorities of the Member State in question. By 31 December 2009, the Commission shall adopt a Decision on minimum requirements for the data to be entered in the national electronic register from the date of its setting-up in order to facilitate the future interconnection of registers. It may recommend the inclusion of the vehicle registration marks in addition to the data referred to in paragraph 2. 2. National electronic registers shall contain at least the following data: (a) the name and legal form of the undertaking; (b) the address of its establishment; (c) the names of the transport managers designated to meet the conditions as to good repute and professional competence or, as appropriate, the name of a legal representative; (d) the type of authorisation, the number of vehicles it covers and, where appropriate, the serial number of the Community licence and of the certified copies; (e) the number, category and type of serious infringements, as referred to in Article 6(1)(b), which have resulted in a conviction or penalty during the last 2 years; (f) the name of any person declared to be unfit to manage the transport activities of an undertaking, as long as the good repute of that person has not been re-established pursuant to Article 6(3), and the rehabilitation measures applicable. For the purposes of point (e), Member States may, until 31 December 2015, choose to include in the national electronic register only the most serious infringements set out in Annex IV. Member States may choose to keep the data referred to in points (e) and (f) of the first subparagraph in separate registers. In such a case, the relevant data shall be available upon request or directly accessible to all the competent authorities of the Member State in question. The requested information shall be provided within 30 working days of receipt of the request. The data referred to in points (a) to (d) of the first subparagraph shall be publicly accessible, in accordance with the relevant provisions on personal data protection. In any case, the data referred to in points (e) and (f) of the first subparagraph shall only be accessible to authorities other than the competent authorities where they are duly endowed with powers relating to supervision and the imposition of penalties in the road transport sector and their officials are sworn to, or otherwise are under a formal obligation of, secrecy. 3. Data concerning an undertaking whose authorisation has been suspended or withdrawn shall remain in the national electronic register for 2 years from the expiry of the suspension or the withdrawal of the licence, and shall thereafter be immediately removed. Data concerning any person declared to be unfit for the occupation of road transport operator shall remain in the national electronic register as long as the good repute of that person has not been re-established pursuant to Article 6(3). Where such a rehabilitation measure or any other measure having an equivalent effect is taken, the data shall be immediately removed. The data referred to in the first and second subparagraphs shall specify the reasons for the suspension or withdrawal of the authorisation or the declaration of unfitness, as appropriate, and the corresponding duration. 4. Member States shall take all necessary measures to ensure that all the data contained in the national electronic register is kept up to date and is accurate, in particular the data referred to in points (e) and (f) of the first subparagraph of paragraph 2. 5. Without prejudice to paragraphs 1 and 2, Member States shall take all necessary measures to ensure that the national electronic registers are interconnected and accessible throughout the Community through the national contact points defined in Article 18. Accessibility through national contact points and interconnection shall be implemented by 31 December 2012 in such a way that a competent authority of any Member State is able to consult the national electronic register of any Member State. 6. Common rules concerning the implementation of paragraph 5, such as the format of the data exchanged, the technical procedures for electronic consultation of the national electronic registers of the other Member States and the promotion of the interoperability of these registers with other relevant databases, shall be adopted by the Commission in accordance with the advisory procedure referred to in Article 25(2) and for the first time before 31 December 2010. Those common rules shall determine which authority is responsible for access to data and further use and updating of data after access and, to this effect, shall include rules on data logging and data monitoring. 7. Measures designed to amend non-essential elements of this Regulation and relating to a postponement of the time limits referred to in paragraphs 1 and 5 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). Article 17 Protection of personal data With regard to the application of Directive 95/46/EC, Member States shall ensure in particular that: (a) all persons are informed when data relating to them is recorded or is planned to be forwarded to third parties. The information provided shall specify the identity of the authority responsible for processing the data, the type of data processed and the reasons for such action; (b) all persons have a right of access to data relating to them held by the authority responsible for processing those data. That right shall be exercisable without constraint, at reasonable intervals and without excessive delay or cost for the applicant; (c) all persons whose data are incomplete or inaccurate have the right to have those data rectified, erased or blocked; (d) all persons have the right to oppose, on compelling legitimate grounds, the processing of data relating to them. Where there is justified opposition, the processing may no longer involve those data; (e) undertakings comply, where applicable, with the relevant provisions on the protection of personal data. Article 18 Administrative cooperation between Member States 1. Member States shall designate a national contact point responsible for the exchange of information with the other Member States with regard to the application of this Regulation. Member States shall forward to the Commission the names and addresses of their national contact points by 4 December 2011. The Commission shall draw up a list of all contact points and forward it to the Member States. 2. Member States which exchange information in the framework of this Regulation shall use the national contact points designated pursuant to paragraph 1. 3. Member States which exchange information on the infringements referred to in Article 6(2) or on transport managers declared to be unfit shall comply with the procedure and time limits referred to in Article 13(1) of Regulation (EC) No 1072/2009 or, as appropriate, Article 23(1) of Regulation (EC) No 1073/2009. A Member State which receives notification of a serious infringement which has resulted in a conviction or a penalty in another Member State shall record that infringement in its national electronic register. CHAPTER V MUTUAL RECOGNITION OF CERTIFICATES AND OTHER DOCUMENTS Article 19 Certificates of good repute and equivalent documents 1. Without prejudice to Article 11(4), the Member State of establishment shall accept as sufficient proof of good repute for admission to the occupation of road transport operator the production of an extract from a judicial record or, failing that, an equivalent document issued by a competent judicial or administrative authority in the Member State where the transport manager or any other relevant person used to reside. 2. Where a Member State imposes on its own nationals certain conditions relating to good repute, and proof that these conditions are met cannot be provided by means of the document referred to in paragraph 1, that Member State shall accept as sufficient proof for nationals of other Member States a certificate issued by a competent judicial or administrative authority in the Member State(s) where the transport manager or any other relevant person used to reside stating that these conditions have been met. Such certificate shall relate to the specific information taken into consideration in the Member State of establishment. 3. If the document referred to in paragraph 1 or the certificate referred to in paragraph 2 has not been issued by the Member State(s) where the transport manager or any other relevant person used to reside, that document or certificate may be replaced by a declaration on oath or by a solemn declaration made by the transport manager or any other relevant person before a competent judicial or administrative authority or, where appropriate, before a notary in the Member State where the transport manager or any other relevant person used to reside. Such authority or notary shall issue a certificate authenticating the declaration on oath or the solemn declaration. 4. A document referred to in paragraph 1 and a certificate referred to in paragraph 2 shall not be accepted if produced more than 3 months after their date of issue. This condition shall also apply to a declaration made in accordance with paragraph 3. Article 20 Certificates relating to financial standing Where a Member State imposes on its nationals certain conditions relating to financial standing in addition to those set out in Article 7, that Member State shall accept as sufficient proof for nationals of other Member States a certificate issued by a competent authority in the Member State(s) where the transport manager or any other relevant person used to reside stating that these conditions have been met. Such certificate shall relate to the specific information taken into consideration in the new Member State of establishment. Article 21 Certificates of professional competence 1. Member States shall recognise as sufficient proof of professional competence a certificate which complies with the model certificate set out in Annex III and which is issued by the authority or body duly authorised for that purpose. 2. A certificate issued before 4 December 2011 as proof of professional competence pursuant to the provisions in force until that date shall be deemed to be equivalent to a certificate which complies with the model certificate set out in Annex III and shall be recognised as proof of professional competence in all Member States. Member States may require that holders of certificates of professional competence valid only for national transport pass the examinations, or parts of the examinations, referred to in Article 8(1). CHAPTER VI FINAL PROVISIONS Article 22 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation, and shall take all the measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 4 December 2011 at the latest and shall notify it without delay of any subsequent amendment affecting them. Member States shall ensure that all such measures are applied without discrimination as to the nationality or place of establishment of the undertaking. 2. The penalties referred to in paragraph 1 shall include, in particular, suspension of the authorisation to engage in the occupation of road transport operator, withdrawal of such authorisation and a declaration of unfitness of the transport manager. Article 23 Transitional provisions Undertakings which before 4 December 2009 have an authorisation to engage in the occupation of road transport operator shall comply with the provisions of this Regulation by 4 December 2011. Article 24 Mutual assistance The competent authorities of the Member States shall cooperate closely and shall give each other mutual assistance for the purposes of applying this Regulation. They shall exchange information on convictions and penalties for any serious infringements, and other specific information liable to have consequences for the pursuit of the occupation of road transport operator, in compliance with the provisions applicable to the protection of personal data. Article 25 Committee procedure 1. The Commission shall be assisted by the Committee set up by Article 18(1) of Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording equipment in road transport (11). 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 26 Reporting 1. Every 2 years, Member States shall draw up a report on the activities of the competent authorities and shall forward it to the Commission. This report shall comprise: (a) an overview of the sector with regard to good repute, financial standing and professional competence; (b) the number of authorisations granted by year and by type, those suspended, those withdrawn, the number of declarations of unfitness and the reasons on which those decisions were based; (c) the number of certificates of professional competence issued each year; (d) core statistics relating to the national electronic registers and their use by the competent authorities; and (e) an overview of exchanges of information with other Member States pursuant to Article 18(2), including in particular the annual number of established infringements notified to other Member States and the replies received, as well as the annual number of requests and replies received pursuant to Article 18(3). 2. On the basis of the reports referred to in paragraph 1, the Commission shall, every 2 years, submit a report to the European Parliament and to the Council on the pursuit of the occupation of road transport operator. That report shall contain, in particular, an assessment of the operation of the exchange of information between Member States and a review of the functioning and data contained in the national electronic registers. It shall be published at the same time as the report referred to in Article 17 of Regulation (EC) No 561/2006 of the European Parliament and of the Council of 15 March 2006 on the harmonisation of certain social legislation relating to road transport (12). Article 27 List of competent authorities Each Member State shall forward to the Commission by 4 December 2011 a list of competent authorities which it has designated to authorise the pursuit of the occupation of road transport operator and a list of the authorised authorities or bodies responsible for organising the examinations referred to in Article 8(1) and issuing the certificates. A consolidated list of those authorities and bodies throughout the Community shall be published by the Commission in the Official Journal of the European Union. Article 28 Communication of national measures Member States shall communicate to the Commission the text of the laws, regulations and administrative provisions which they adopt in the field governed by this Regulation no later than 30 days after their date of adoption and for the first time by 4 December 2011. Article 29 Repeal Directive 96/26/EC is hereby repealed. Article 30 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply with effect from 4 December 2011. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 21 October 2009. For the European Parliament The President J. BUZEK For the Council The President C. MALMSTR\u00d6M (1) OJ C 151, 17.6.2008, p. 16. (2) OJ C 14, 19.1.2008, p. 1. (3) Opinion of the European Parliament of 21 May 2008 (not yet published in the Official Journal), Council Common Position of 9 January 2009 (OJ C 62 E, 17.3.2009, p. 1), Position of the European Parliament of 23 April 2009 (not yet published in the Official Journal) and Council Decision of 24 September 2009. (4) OJ L 124, 23.5.1996, p. 1. (5) See page 72 of this Official Journal. (6) See page 88 of this Official Journal. (7) OJ L 281, 23.11.1995, p. 31. (8) OJ L 184, 17.7.1999, p. 23. (9) OJ L 222, 14.8.1978, p. 11. (10) OJ L 102, 11.4.2006, p. 35. (11) OJ L 370, 31.12.1985, p. 8. (12) OJ L 102, 11.4.2006, p. 1. ANNEX I I. LIST OF SUBJECTS REFERRED TO IN ARTICLE 8 The knowledge to be taken into consideration for the official recognition of professional competence by Member States must cover at least the subjects listed below for road haulage and road passenger transport respectively. In relation to these subjects, applicant road haulage and road passenger transport operators must have the levels of knowledge and practical aptitude necessary for the management of a transport undertaking. The minimum level of knowledge, as indicated below, may not be below level 3 of the training-level structure laid down in the Annex to Council Decision 85/368/EEC (1), namely the level of knowledge acquired during the course of compulsory education, which is supplemented either by vocational training and supplementary technical training or by secondary school or other technical training. A. Civil law The applicant must, in particular, in relation to road haulage and passenger transport: 1. be familiar with the main types of contract used in road transport and with the rights and obligations arising therefrom; 2. be capable of negotiating a legally valid transport contract, notably with regard to conditions of carriage; in relation to road haulage: 3. be able to consider a claim by his principal regarding compensation for loss of or damage to goods during transportation or for their late delivery, and to understand how such a claim affects his contractual liability; 4. be familiar with the rules and obligations arising from the CMR Convention on the Contract for the International Carriage of Goods by Road; in relation to road passenger transport: 5. be able to consider a claim by his principal regarding compensation for injury to passengers or damage to their baggage caused by an accident during transportation, or regarding compensation for delays, and to understand how such a claim affects his contractual liability. B. Commercial law The applicant must, in particular, in relation to road haulage and passenger transport: 1. be familiar with the conditions and formalities laid down for plying the trade, the general obligations incumbent upon transport operators (registration, record keeping, etc.) and the consequences of bankruptcy; 2. have appropriate knowledge of the various forms of commercial companies and the rules governing their constitution and operation. C. Social law The applicant must, in particular, in relation to road haulage and passenger transport, be familiar with the following: 1. the role and function of the various social institutions which are concerned with road transport (trade unions, works councils, shop stewards, labour inspectors, etc.); 2. the employers\u2019 social security obligations; 3. the rules governing work contracts for the various categories of worker employed by road transport undertakings (form of the contracts, obligations of the parties, working conditions and working hours, paid leave, remuneration, breach of contract, etc.); 4. the rules applicable to driving time, rest periods and working time, and in particular the provisions of Regulation (EEC) No 3821/85, Regulation (EC) No 561/2006, Directive 2002/15/EC of the European Parliament and of the Council (2) and Directive 2006/22/EC, and the practical measures for applying those provisions; and 5. the rules applicable to the initial qualification and continuous training of drivers, and in particular those deriving from Directive 2003/59/EC of the European Parliament and of the Council (3). D. Fiscal law The applicant must, in particular, in relation to road haulage and passenger transport, be familiar with the rules governing: 1. value added tax (VAT) on transport services; 2. motor-vehicle tax; 3. the taxes on certain road haulage vehicles and tolls and infrastructure user charges; 4. income tax. E. Business and financial management of the undertaking The applicant must, in particular, in relation to road haulage and passenger transport: 1. be familiar with the laws and practices regarding the use of cheques, bills of exchange, promissory notes, credit cards and other means or methods of payment; 2. be familiar with the various forms of credit (bank credit, documentary credit, guarantee deposits, mortgages, leasing, renting, factoring, etc.) and the charges and obligations arising therefrom; 3. know what a balance sheet is, how it is set out and how to interpret it; 4. be able to read and interpret a profit and loss account; 5. be able to assess the undertaking\u2019s profitability and financial position, in particular on the basis of financial ratios; 6. be able to prepare a budget; 7. be familiar with the cost elements of the undertaking (fixed costs, variable costs, working capital, depreciation, etc.), and be able to calculate costs per vehicle, per kilometre, per journey or per tonne; 8. be able to draw up an organisation chart relating to the undertaking\u2019s personnel as a whole and to organise work plans, etc.; 9. be familiar with the principles of marketing, publicity and public relations, including transport services, sales promotion and the preparation of customer files, etc.; 10. be familiar with the different types of insurance relating to road transport (liability, accidental injury/life insurance, non-life and luggage insurance) and the guarantees and obligations arising therefrom; 11. be familiar with the applications of electronic data transmission in road transport; in relation to road haulage: 12. be able to apply the rules governing the invoicing of road haulage services and know the meaning and implications of Incoterms; 13. be familiar with the different categories of transport auxiliaries, their role, their functions and, where appropriate, their status; in relation to road passenger transport: 14. be able to apply the rules governing fares and pricing in public and private passenger transport; 15. be able to apply the rules governing the invoicing of road passenger transport services. F. Access to the market The applicant must, in particular, in relation to road haulage and passenger transport, be familiar with the following: 1. the occupational regulations governing road transport for hire or reward, industrial vehicle rental and subcontracting, and in particular the rules governing the official organisation of the occupation, admission to the occupation, authorisations for intra-Community and extra-Community road transport operations, inspections and penalties; 2. the rules for setting up a road transport undertaking; 3. the various documents required for operating road transport services and the introduction of checking procedures to ensure that the approved documents relating to each transport operation, and in particular those relating to the vehicle, the driver, the goods and luggage are kept both in the vehicle and on the premises of the undertaking; in relation to road haulage: 4. the rules on the organisation of the market in road haulage services, as well as the rules on freight handling and logistics; 5. border formalities, the role and scope of T documents and TIR carnets, and the obligations and responsibilities arising from their use; in relation to road passenger transport: 6. the rules on the organisation of the market in road passenger transport; 7. the rules for introducing road passenger transport services and the drawing up of transport plans. G. Technical standards and technical aspects of operation The applicant must, in particular, in relation to road haulage and passenger transport: 1. be familiar with the rules concerning the weights and dimensions of vehicles in the Member States and the procedures to be followed in the case of abnormal loads which constitute an exception to these rules; 2. be able to choose vehicles and their components (chassis, engine, transmission system, braking system, etc.) in accordance with the needs of the undertaking; 3. be familiar with the formalities relating to the type approval, registration and technical inspection of these vehicles; 4. understand what measures must be taken to reduce noise and to combat air pollution by motor vehicle exhaust emissions; 5. be able to draw up periodic maintenance plans for the vehicles and their equipment; in relation to road haulage: 6. be familiar with the different types of cargo-handling and loading devices (tailboards, containers, pallets, etc.) and be able to introduce procedures and issue instructions for loading and unloading goods (load distribution, stacking, stowing, blocking and chocking, etc.); 7. be familiar with the various techniques of \u2018piggy-back\u2019 and roll-on roll-off combined transport; 8. be able to implement procedures to comply with the rules on the carriage of dangerous goods and waste, notably those arising from Directive 2008/68/EC (4) and Regulation (EC) No 1013/2006 (5); 9. be able to implement procedures to comply with the rules on the carriage of perishable foodstuffs, notably those arising from the Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to be used for such Carriage (ATP); 10. be able to implement procedures to comply with the rules on the transport of live animals. H. Road safety The applicant must, in particular, in relation to road haulage and passenger transport: 1. know what qualifications are required for drivers (driving licence, medical certificates, certificates of fitness, etc.); 2. be able to take the necessary steps to ensure that drivers comply with the traffic rules, prohibitions and restrictions in force in different Member States (speed limits, priorities, waiting and parking restrictions, use of lights, road signs, etc.); 3. be able to draw up instructions for drivers to check their compliance with the safety requirements concerning the condition of the vehicles, their equipment and cargo, and concerning preventive measures to be taken; 4. be able to lay down procedures to be followed in the event of an accident and to implement appropriate procedures to prevent the recurrence of accidents or serious traffic offences; 5. be able to implement procedures to properly secure goods and be familiar with the corresponding techniques; in relation to road passenger transport: 6. have elementary knowledge of the layout of the road network in the Member States. II. ORGANISATION OF THE EXAMINATION 1. Member States will organise a compulsory written examination which they may supplement by an optional oral examination to establish whether applicant road transport operators have achieved the required level of knowledge in the subjects listed in Part I and in particular their capacity to use the instruments and techniques relating to those subjects and to fulfil the corresponding executive and coordination duties. (a) The compulsory written examination will involve two tests, namely: (i) written questions consisting of either multiple choice questions (each with four possible answers), questions requiring direct answers or a combination of both systems; (ii) written exercises/case studies. The minimum duration of each test will be two hours. (b) Where an oral examination is organised, Member States may stipulate that participation is subject to the successful completion of the written examination. 2. Where Member States also organise an oral examination, they must provide, in respect of each of the three tests, for a weighting of marks of a minimum of 25 % and a maximum of 40 % of the total number of marks to be given. Where Member States organise only a written examination, they must provide, in respect of each test, for a weighting of marks of a minimum of 40 % and a maximum of 60 % of the total number of marks to be given. 3. With regard to all the tests, applicants must obtain an average of at least 60 % of the total number of marks to be given, achieving in any given test not less than 50 % of the total number of marks possible. In one test only, a Member State may reduce that mark from 50 % to 40 %. (1) Council Decision 85/368/EEC of 16 July 1985 on the comparability of vocational training qualifications between the Member States of the European Community (OJ L 199, 31.7.1985, p. 56). (2) Directive 2002/15/EC of the European Parliament and of the Council of 11 March 2002 on the organisation of the working time of persons performing mobile road transport activities (OJ L 80, 23.3.2002, p. 35). (3) Directive 2003/59/EC of the European Parliament and of the Council of 15 July 2003 on the initial qualification and periodic training of drivers of certain road vehicles for the carriage of goods or passengers (OJ L 226, 10.9.2003, p. 4). (4) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13). (5) Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste (OJ L 190, 12.7.2006, p. 1). ANNEX II Security features of the certificate of professional competence The certificate must have at least two of the following security features: \u2014 a hologram, \u2014 special fibres in the paper which become visible under UV light, \u2014 at least one microprint line (printing visible only with a magnifying glass and not reproduced by photocopying machines), \u2014 tactile characters, symbols or patterns, \u2014 double numbering: serial number and issue number, \u2014 a security design background with fine guilloche patterns and rainbow printing. ANNEX III Model of the certificate of professional competence EUROPEAN COMMUNITY (Colour Pantone stout fawn, format DIN A 4 cellulose paper 100 g/m2 or more) (Text in the official language(s) or one of the official languages of the Member State issuing the certificate) Distinguishing sign of the Member State concerned (1) Name of the authorised authority or body (2) CERTIFICATE OF PROFESSIONAL COMPETENCE IN ROAD HAULAGE/PASSENGER TRANSPORT (3) No \u2026 We \u2026 hereby certify that (4) \u2026 born on \u2026 in \u2026 has successfully passed the tests for the examination (year: \u2026; session: \u2026) (5) necessary for the award of the certificate of professional competence in road haulage/passenger transport (3) in accordance with Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator (6). This certificate constitutes the sufficient proof of professional competence referred to in Article 21 of Regulation (EC) No 1071/2009. Issued at \u2026, on \u2026 (7) (1) The distinguishing signs of the Member States are: (B) Belgium, (BG) Bulgaria, (CZ) Czech Republic, (DK) Denmark, (D) Germany, (EST) Estonia, (IRL) Ireland, (GR) Greece, (E) Spain, (F) France, (I) Italy, (CY) Cyprus, (LV) Latvia, (LT) Lithuania, (L) Luxembourg, (H) Hungary, (M) Malta, (NL) Netherlands, (A) Austria, (PL) Poland, (P) Portugal, (RO) Romania, (SLO) Slovenia, (SK) Slovakia, (FIN) Finland, (S) Sweden, (UK) United Kingdom. (2) Authority or body designated in advance for this purpose by each Member State of the European Community to issue this certificate. (3) Delete as appropriate. (4) Surname and forename; place and date of birth. (5) Identification of the examination. (6) OJ L 300, 14.11.2009, p. 51 (7) Seal and signature of the authorised authority or body issuing the certificate. ANNEX IV Most serious infringements for the purposes of Article 6(2)(a) 1. (a) Exceeding the maximum 6-day or fortnightly driving time limits by margins of 25 % or more. (b) Exceeding, during a daily working period, the maximum daily driving time limit by a margin of 50 % or more without taking a break or without an uninterrupted rest period of at least 4,5 hours. 2. Not having a tachograph and/or speed limiter, or using a fraudulent device able to modify the records of the recording equipment and/or the speed limiter or falsifying record sheets or data downloaded from the tachograph and/or the driver card. 3. Driving without a valid roadworthiness certificate if such a document is required under Community law and/or driving with a very serious deficiency of, inter alia, the braking system, the steering linkages, the wheels/tyres, the suspension or chassis that would create such an immediate risk to road safety that it leads to a decision to immobilise the vehicle. 4. Transporting dangerous goods that are prohibited for transport or transporting such goods in a prohibited or non-approved means of containment or without identifying them on the vehicle as dangerous goods, thus endangering lives or the environment to such extent that it leads to a decision to immobilise the vehicle. 5. Carrying passengers or goods without holding a valid driving licence or carrying by an undertaking not holding a valid Community licence. 6. Driving with a driver card that has been falsified, or with a card of which the driver is not the holder, or which has been obtained on the basis of false declarations and/or forged documents. 7. Carrying goods exceeding the maximum permissible laden mass by 20 % or more for vehicles the permissible laden weight of which exceeds 12 tonnes, and by 25 % or more for vehicles the permissible laden weight of which does not exceed 12 tonnes.", "summary": "Road haulage and passenger transport companies: operating rules Road haulage and passenger transport companies: operating rules SUMMARY OF: Regulation (EC) No 1071/2009 setting common rules concerning the conditions to be complied with to pursue the occupation of road transport operator Regulation (EU) 2020/1055 amending Regulation (EC) No 1071/2009 to adapt it to developments in the road transport sector WHAT IS THE AIM OF THE REGULATION? Regulation (EC) No 1071/2009: sets out rules for companies wanting to enter and be active in the road haulage (i.e. transport of goods by road) and passenger transport business; applies to all companies established in the EU that are active in (or intending to be active in) transporting goods or people in exchange for payment. Amending Regulation (EU) 2020/1055 updates the rules for pursuing the occupation of road transport operator in order to combat the phenomenon of letterbox companies* and unfair competition. KEY POINTS Companies active in the road transport operator business must: be effectively and stably established in an EU country; be of good repute; have appropriate financial standing; and have the required professional competence. Transport manager Every road transport company must designate a transport manager who is responsible for continuously managing its transport activities. This manager must reside in the EU and have a genuine link to the undertaking, for example as an employee, administrator or shareholder. How to become a road transport operator A company wanting to be active in the road transport operator business must be established in an EU country with premises in that EU country where it can keep all of the documents (accounts, personnel management documents and data relating to driving time and rest, etc.) required for its business. The company should have at least one vehicle registered in that EU country at its disposal (once an authorisation has been granted) and have an operating centre situated in that country with the appropriate technical equipment and facilities for the operation of the vehicle(s). In addition: neither the company nor the manager can have been convicted for any infringement of certain national and EU rules relating to road transport;the company must be able to meet its financial obligations;the manager must have passed a compulsory written examination, which may be supplemented by an oral examination. Authorisation and monitoring EU countries must designate one or more competent authorities responsible for: examining applications made by companies;granting permits to set up as a road transport operator;declaring a person to be fit/unfit to manage a company\u2019s transport activities;checking that the company fulfils all the relevant requirements. The competent authorities are also responsible for following up companies\u2019 applications for registration within 3 months. In addition, they can declare a company unfit to manage transport activities. Simplification and administrative cooperation Each EU country must keep a national electronic register of companies authorised to be active in the road transport operator business. The competent national authorities are responsible for supervising the data in that register. The national registers are to be interconnected, allowing the competent authorities of any EU country to consult the national electronic register of any other EU country. Amending Regulation (EU) 2020/1055 The main changes introduced to Regulation (EC) No 1071/2009 by amending Regulation (EU) 2020/1055 include the following. Replacing the article on conditions relating to the requirement of a transport undertaking being established (Article 5 of Regulation (EC) No 1071/2009) in order to combat the phenomenon of letterbox companies. It thus tightens the link between the transport operator\u2019s place of establishment and its activities. Extending the rules to cover vans used in international transport (light commercial vehicles weighing over 2.5 tonnes). Requiring the European Commission to adopt implementing acts laying down a list of categories, types and degrees of gravity of serious infringements of EU rules. Introducing new administrative procedures where a transport manager or a company has seriously infringed EU rules. Introducing new rules concerning a haulier\u2019s good repute: the minimum period after which transport managers who have lost their good repute can have it restored is 1 year. Managers who have lost their good repute must prove that they have followed a minimum level of training or passed an examination demonstrating knowledge of the subjects listed in Annex I of Regulation (EC) No 1071/2009. Revising Annex IV of Regulation (EC) No 1071/2009 clarifying the most serious infringements. Requiring transport companies to demonstrate, on the basis of annual accounts certified by an auditor or a duly accredited person, that for each year it has specific levels of capital and reserves at its disposal. FROM WHEN DOES THIS REGULATION APPLY? Regulation (EC) No 1071/2009 has applied since 4 December 2011. Amending Regulation (EU) 2020/1055 will apply from 21 February 2022. BACKGROUND For more information, see: Rules governing access to the profession (European Commission). KEY TERMS Letterbox companies: companies which have been set up with the purpose of benefitting from legislative loopholes while not providing any service to clients themselves, but rather providing a front for services provided by their owners (COM(2013) 122 final). MAIN DOCUMENTS Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC (OJ L 300, 14.11.2009, pp. 51-71) Successive amendments to Regulation (EC) No 1071/2009 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EU) 2020/1055 of the European Parliament and of the Council of 15 July 2020 amending Regulations (EC) No 1071/2009, (EC) No 1072/2009 and (EU) No 1024/2012 with a view to adapting them to developments in the road transport sector (OJ L 249, 31.7.2020, pp. 17-32) RELATED DOCUMENTS Report from the Commission to the European Parliament and the Council on the implementation in the period from 4 December 2011 until 31 December 2012 of certain provisions of Regulation (EC) No 1071/2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator (1st report from the Commission on the implementation by Member States of certain provisions concerning the access to the occupation of road transport operator) (COM(2014) 592 final of 25.9.2014). last update 09.10.2020"}
{"article": "30.10.2009 EN Official Journal of the European Union L 284/1 REGULATION (EC) No 987/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (Text with relevance for the EEA and for Switzerland) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Articles 42 and 308 thereof, Having regard to Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (1), and in particular Article 89 thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Regulation (EC) No 883/2004 modernises the rules on the coordination of Member States\u2019 social security systems, specifying the measures and procedures for implementing them and simplifying them for all the players involved. Implementing rules should be laid down. (2) Closer and more effective cooperation between social security institutions is a key factor in allowing the persons covered by Regulation (EC) No 883/2004 to access their rights as quickly as possible and under optimum conditions. (3) Electronic communication is a suitable means of rapid and reliable data exchange between Member States\u2019 institutions. Processing data electronically should help speed up the procedures for everyone involved. The persons concerned should also benefit from all the guarantees provided for in the Community provisions on the protection of natural persons with regard to the processing and free movement of personal data. (4) Availability of the details (including electronic details) of those national bodies likely to be involved in implementing Regulation (EC) No 883/2004, in a form which allows them to be updated in real time, should facilitate exchanges between Member States\u2019 institutions. This approach, which focuses on the relevance of purely factual information and its immediate accessibility to citizens, is a valuable simplification which should be introduced by this Regulation. (5) Achieving the smoothest possible operation and the efficient management of the complex procedures implementing the rules on the coordination of social security systems requires a system for the immediate updating of Annex 4. The preparation and application of provisions to that effect calls for close cooperation between the Member States and the Commission, and their implementation should be carried out rapidly, in view of the consequences of delays for citizens and administrative authorities alike. The Commission should therefore be empowered to establish and manage a database and ensure that it is operational at least from the date of entry into force of this Regulation. The Commission should, in particular, take the necessary steps to integrate into that database the information listed in Annex 4. (6) Strengthening certain procedures should ensure greater legal certainty and transparency for the users of Regulation (EC) No 883/2004. For example, setting common deadlines for fulfilling certain obligations or completing certain administrative tasks should assist in clarifying and structuring relations between insured persons and institutions. (7) The persons covered by this Regulation should receive from the competent institution a timely response to their requests. The response should be provided at the latest within the time-limits prescribed by the social security legislation of the Member State in question, where such time-limits exist. It would be desirable for Member States whose social security legislation does not make provision for such time-limits to consider adopting them and making them available to the persons concerned as necessary. (8) The Member States, their competent authorities and the social security institutions should have the option of agreeing among themselves on simplified procedures and administrative arrangements which they consider to be more effective and better suited to the circumstances of their respective social security systems. However, such arrangements should not affect the rights of the persons covered by Regulation (EC) No 883/2004. (9) The inherent complexity of the field of social security requires all institutions of the Member States to make a particular effort to support insured persons in order to avoid penalising those who have not submitted their claim or certain information to the institution responsible for processing this application in accordance with the rules and procedures set out in Regulation (EC) No 883/2004 and in this Regulation. (10) To determine the competent institution, namely the one whose legislation applies or which is liable for the payment of certain benefits, the circumstances of the insured person and those of the family members must be examined by the institutions of more than one Member State. To ensure that the person concerned is protected for the duration of the necessary communication between institutions, provision should be made for provisional membership of a social security system. (11) Member States should cooperate in determining the place of residence of persons to whom this Regulation and Regulation (EC) No 883/2004 apply and, in the event of a dispute, should take into consideration all relevant criteria to resolve the matter. These may include criteria referred to in the appropriate Article of this Regulation. (12) Many measures and procedures provided for in this Regulation are intended to ensure greater transparency concerning the criteria which the institutions of the Member States must apply under Regulation (EC) No 883/2004. Such measures and procedures are the result of the case-law of the Court of Justice of the European Communities, the decisions of the Administrative Commission and the experience of more than 30 years of application of the coordination of social security systems in the context of the fundamental freedoms enshrined in the Treaty. (13) This Regulation provides for measures and procedures to promote the mobility of employees and unemployed persons. Frontier workers who have become wholly unemployed may make themselves available to the employment services in both their country of residence and the Member State where they were last employed. However, they should be entitled to benefits only from their Member State of residence. (14) Certain specific rules and procedures are required in order to define the legislation applicable for taking account of periods during which an insured person has devoted time to bringing up children in the various Member States. (15) Certain procedures should also reflect the need for a balanced sharing of costs between Member States. In particular in the area of sickness, such procedures should take account of the position of Member States which bear the costs of allowing insured persons access to their healthcare system and the position of Member States whose institutions bear the cost of benefits in kind received by their insured persons in a Member State other than that in which they are resident. (16) In the specific context of Regulation (EC) No 883/2004, it is necessary to clarify the conditions for meeting the costs of sickness benefits in kind as part of scheduled treatments, namely treatments for which an insured person goes to a Member State other than that in which he is insured or resident. The obligations of the insured person with regard to the application for prior authorisation should be specified, as should the institution\u2019s obligations towards the patient with regard to the conditions of authorisation. The consequences for the chargeability of the costs of care received in another Member State on the basis of an authorisation should also be clarified. (17) This Regulation, and especially the provisions concerning the stay outside the competent Member State and concerning scheduled treatment, should not prevent the application of more favourable national provisions, in particular with regard to the reimbursement of costs incurred in another Member State. (18) More binding procedures to reduce the time needed for payment of these claims between Member States\u2019 institutions are essential in order to maintain confidence in the exchanges and meet the need for sound management of Member States\u2019 social security systems. Procedures for the processing of claims relating to sickness and unemployment benefits should therefore be strengthened. (19) Procedures between institutions for mutual assistance in recovery of social security claims should be strengthened in order to ensure more effective recovery and smooth functioning of the coordination rules. Effective recovery is also a means of preventing and tackling abuses and fraud and a way of ensuring the sustainability of social security schemes. This involves the adoption of new procedures, taking as a basis a number of existing provisions in Council Directive 2008/55/EC of 26 May 2008 on mutual assistance for the recovery of claims relating to certain levies, duties, taxes and other measures (4). Such new recovery procedures should be reviewed in the light of the experience after five years of implementation and adjusted if necessary, in particular to ensure they are fully operable. (20) For the purposes of provisions on mutual assistance regarding the recovery of benefits provided but not due, the recovery of provisional payments and contributions and the offsetting and assistance with recovery, the jurisdiction of the requested Member State is limited to actions regarding enforcement measures. Any other action falls under the jurisdiction of the applicant Member State. (21) The enforcement measures taken in the requested Member State do not imply the recognition by that Member State of the substance or basis of the claim. (22) Informing the persons concerned of their rights and obligations is a crucial component of a relationship of trust with the competent authorities and the Member States\u2019 institutions. Information should include guidance on administrative procedures. The persons concerned may include, depending on the situation, the insured persons, their family members and/or their survivors or other persons. (23) Since the objective of this Regulation, namely the adoption of coordination measures in order to guarantee the effective exercise of the free movement of persons, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (24) This Regulation should replace Council Regulation (EEC) No 574/72 of 21 March 1972 fixing the procedure for implementing Regulation (EEC) No 1408/71 on the application of social security schemes to employed persons and their families moving within the Community (5), HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS CHAPTER I Definitions Article 1 Definitions 1. For the purposes of this Regulation: (a) \u2018basic Regulation\u2019 means Regulation (EC) No 883/2004; (b) \u2018implementing Regulation\u2019 means this Regulation; and (c) the definitions set out in the basic Regulation shall apply. 2. In addition to the definitions referred to in paragraph 1, (a) \u2018access point\u2019 means an entity providing: (i) an electronic contact point; (ii) automatic routing based on the address; and (iii) intelligent routing based on software that enables automatic checking and routing (for example, an artificial intelligence application) and/or human intervention; (b) \u2018liaison body\u2019 means any body designated by the competent authority of a Member State for one or more of the branches of social security referred to in Article 3 of the basic Regulation to respond to requests for information and assistance for the purposes of the application of the basic Regulation and the implementing Regulation and which has to fulfil the tasks assigned to it under Title IV of the implementing Regulation; (c) \u2018document\u2019 means a set of data, irrespective of the medium used, structured in such a way that it can be exchanged electronically and which must be communicated in order to enable the operation of the basic Regulation and the implementing Regulation; (d) \u2018Structured Electronic Document\u2019 means any structured document in a format designed for the electronic exchange of information between Member States; (e) \u2018transmission by electronic means\u2019 means the transmission of data using electronic equipment for the processing (including digital compression) of data and employing wires, radio transmission, optical technologies or any other electromagnetic means; (f) \u2018Audit Board\u2019 means the body referred to in Article 74 of the basic Regulation. CHAPTER II Provisions concerning cooperation and exchanges of data Article 2 Scope and rules for exchanges between institutions 1. For the purposes of the implementing Regulation, exchanges between Member States\u2019 authorities and institutions and persons covered by the basic Regulation shall be based on the principles of public service, efficiency, active assistance, rapid delivery and accessibility, including e-accessibility, in particular for the disabled and the elderly. 2. The institutions shall without delay provide or exchange all data necessary for establishing and determining the rights and obligations of persons to whom the basic Regulation applies. Such data shall be transferred between Member States directly by the institutions themselves or indirectly via the liaison bodies. 3. Where a person has mistakenly submitted information, documents or claims to an institution in the territory of a Member State other than that in which the institution designated in accordance with the implementing Regulation is situated, the information, documents or claims shall be resubmitted without delay by the former institution to the institution designated in accordance with the implementing Regulation, indicating the date on which they were initially submitted. That date shall be binding on the latter institution. Member State institutions shall not, however, be held liable, or be deemed to have taken a decision by virtue of their failure to act as a result of the late transmission of information, documents or claims by other Member States\u2019 institutions. 4. Where data are transferred indirectly via the liaison body of the Member State of destination, time limits for responding to claims shall start from the date when that liaison body received the claim, as if it had been received by the institution in that Member State. Article 3 Scope and rules for exchanges between the persons concerned and institutions 1. Member States shall ensure that the necessary information is made available to the persons concerned in order to inform them of the changes introduced by the basic Regulation and by the implementing Regulation to enable them to assert their rights. They shall also provide for user friendly services. 2. Persons to whom the basic Regulation applies shall be required to forward to the relevant institution the information, documents or supporting evidence necessary to establish their situation or that of their families, to establish or maintain their rights and obligations and to determine the applicable legislation and their obligations under it. 3. When collecting, transmitting or processing personal data pursuant to their legislation for the purposes of implementing the basic Regulation, Member States shall ensure that the persons concerned are able to exercise fully their rights regarding personal data protection, in accordance with Community provisions on the protection of individuals with regard to the processing of personal data and the free movement of such data. 4. To the extent necessary for the application of the basic Regulation and the implementing Regulation, the relevant institutions shall forward the information and issue the documents to the persons concerned without delay and in all cases within any time limits specified under the legislation of the Member State in question. The relevant institution shall notify the claimant residing or staying in another Member State of its decision directly or through the liaison body of the Member State of residence or stay. When refusing the benefits it shall also indicate the reasons for refusal, the remedies and periods allowed for appeals. A copy of this decision shall be sent to other involved institutions. Article 4 Format and method of exchanging data 1. The Administrative Commission shall lay down the structure, content, format and detailed arrangements for exchange of documents and structured electronic documents. 2. The transmission of data between the institutions or the liaison bodies shall be carried out by electronic means either directly or indirectly through the access points under a common secure framework that can guarantee the confidentiality and protection of exchanges of data. 3. In their communications with the persons concerned, the relevant institutions shall use the arrangements appropriate to each case, and favour the use of electronic means as far as possible. The Administrative Commission shall lay down the practical arrangements for sending information, documents or decisions by electronic means to the person concerned. Article 5 Legal value of documents and supporting evidence issued in another Member State 1. Documents issued by the institution of a Member State and showing the position of a person for the purposes of the application of the basic Regulation and of the implementing Regulation, and supporting evidence on the basis of which the documents have been issued, shall be accepted by the institutions of the other Member States for as long as they have not been withdrawn or declared to be invalid by the Member State in which they were issued. 2. Where there is doubt about the validity of a document or the accuracy of the facts on which the particulars contained therein are based, the institution of the Member State that receives the document shall ask the issuing institution for the necessary clarification and, where appropriate, the withdrawal of that document. The issuing institution shall reconsider the grounds for issuing the document and, if necessary, withdraw it. 3. Pursuant to paragraph 2, where there is doubt about the information provided by the persons concerned, the validity of a document or supporting evidence or the accuracy of the facts on which the particulars contained therein are based, the institution of the place of stay or residence shall, insofar as this is possible, at the request of the competent institution, proceed to the necessary verification of this information or document. 4. Where no agreement is reached between the institutions concerned, the matter may be brought before the Administrative Commission by the competent authorities no earlier than one month following the date on which the institution that received the document submitted its request. The Administrative Commission shall endeavour to reconcile the points of view within six months of the date on which the matter was brought before it. Article 6 Provisional application of legislation and provisional granting of benefits 1. Unless otherwise provided for in the implementing Regulation, where there is a difference of views between the institutions or authorities of two or more Member States concerning the determination of the applicable legislation, the person concerned shall be made provisionally subject to the legislation of one of those Member States, the order of priority being determined as follows: (a) the legislation of the Member State where the person actually pursues his employment or self-employment, if the employment or self-employment is pursued in only one Member State; (b) the legislation of the Member State of residence where the person concerned performs part of his activity/activities or where the person is not employed or self-employed; (c) the legislation of the Member State the application of which was first requested where the person pursues an activity or activities in two or more Member States. 2. Where there is a difference of views between the institutions or authorities of two or more Member States about which institution should provide the benefits in cash or in kind, the person concerned who could claim benefits if there was no dispute shall be entitled, on a provisional basis, to the benefits provided for by the legislation applied by the institution of his place of residence or, if that person does not reside on the territory of one of the Member States concerned, to the benefits provided for by the legislation applied by the institution to which the request was first submitted. 3. Where no agreement is reached between the institutions or authorities concerned, the matter may be brought before the Administrative Commission by the competent authorities no earlier than one month after the date on which the difference of views, as referred to in paragraph 1 or 2 arose. The Administrative Commission shall seek to reconcile the points of view within six months of the date on which the matter was brought before it. 4. Where it is established either that the applicable legislation is not that of the Member State of provisional membership, or the institution which granted the benefits on a provisional basis was not the competent institution, the institution identified as being competent shall be deemed retroactively to have been so, as if that difference of views had not existed, at the latest from either the date of provisional membership or of the first provisional granting of the benefits concerned. 5. If necessary, the institution identified as being competent and the institution which provisionally paid the cash benefits or provisionally received contributions shall settle the financial situation of the person concerned as regards contributions and cash benefits paid provisionally, where appropriate, in accordance with Title IV, Chapter III, of the implementing Regulation. Benefits in kind granted provisionally by an institution in accordance with paragraph 2 shall be reimbursed by the competent institution in accordance with Title IV of the implementing Regulation. Article 7 Provisional calculation of benefits and contributions 1. Unless otherwise provided for in the implementing Regulation, where a person is eligible for a benefit, or is liable to pay a contribution in accordance with the basic Regulation, and the competent institution does not have all the information concerning the situation in another Member State which is necessary to calculate definitively the amount of that benefit or contribution, that institution shall, on request of the person concerned, award this benefit or calculate this contribution on a provisional basis, if such a calculation is possible on the basis of the information at the disposal of that institution. 2. The benefit or the contribution concerned shall be recalculated once all the necessary supporting evidence or documents are provided to the institution concerned. CHAPTER III Other general provisions for the application of the basic Regulation Article 8 Administrative arrangements between two or more Member States 1. The provisions of the implementing Regulation shall replace those laid down in the arrangements for the application of the conventions referred to in Article 8(1) of the basic Regulation, except the provisions concerning the arrangements concerning the conventions referred to in Annex II to the basic Regulation, provided that the provisions of those arrangements are included in Annex 1 to the implementing Regulation. 2. Member States may conclude between themselves, if necessary, arrangements pertaining to the application of the conventions referred to in Article 8(2) of the basic Regulation provided that these arrangements do not adversely affect the rights and obligations of the persons concerned and are included in Annex 1 to the implementing Regulation. Article 9 Other procedures between authorities and institutions 1. Two or more Member States, or their competent authorities, may agree procedures other than those provided for by the implementing Regulation, provided that such procedures do not adversely affect the rights or obligations of the persons concerned. 2. Any agreements concluded to this end shall be notified to the Administrative Commission and listed in Annex 1 to the implementing Regulation. 3. Provisions contained in implementing agreements concluded between two or more Member States with the same purpose as, or which are similar to, those referred to in paragraph 2, which are in force on the day preceding the entry into force of the implementing Regulation and are included in Annex 5 to Regulation (EEC) No 574/72, shall continue to apply, for the purposes of relations between those Member States, provided they are also included in Annex 1 to the implementing Regulation. Article 10 Prevention of overlapping of benefits Notwithstanding other provisions in the basic Regulation, when benefits due under the legislation of two or more Member States are mutually reduced, suspended or withdrawn, any amounts that would not be paid in the event of strict application of the rules concerning reduction, suspension or withdrawal laid down by the legislation of the Member States concerned shall be divided by the number of benefits subjected to reduction, suspension or withdrawal. Article 11 Elements for determining residence 1. Where there is a difference of views between the institutions of two or more Member States about the determination of the residence of a person to whom the basic Regulation applies, these institutions shall establish by common agreement the centre of interests of the person concerned, based on an overall assessment of all available information relating to relevant facts, which may include, as appropriate: (a) the duration and continuity of presence on the territory of the Member States concerned; (b) the person\u2019s situation, including: (i) the nature and the specific characteristics of any activity pursued, in particular the place where such activity is habitually pursued, the stability of the activity, and the duration of any work contract; (ii) his family status and family ties; (iii) the exercise of any non-remunerated activity; (iv) in the case of students, the source of their income; (v) his housing situation, in particular how permanent it is; (vi) the Member State in which the person is deemed to reside for taxation purposes. 2. Where the consideration of the various criteria based on relevant facts as set out in paragraph 1 does not lead to agreement between the institutions concerned, the person\u2019s intention, as it appears from such facts and circumstances, especially the reasons that led the person to move, shall be considered to be decisive for establishing that person\u2019s actual place of residence. Article 12 Aggregation of periods 1. For the purposes of applying Article 6 of the basic Regulation, the competent institution shall contact the institutions of the Member States to whose legislation the person concerned has also been subject in order to determine all the periods completed under their legislation. 2. The respective periods of insurance, employment, self-employment or residence completed under the legislation of a Member State shall be added to those completed under the legislation of any other Member State, insofar as necessary for the purposes of applying Article 6 of the basic Regulation, provided that these periods do not overlap. 3. Where a period of insurance or residence which is completed in accordance with compulsory insurance under the legislation of a Member State coincides with a period of insurance completed on the basis of voluntary insurance or continued optional insurance under the legislation of another Member State, only the period completed on the basis of compulsory insurance shall be taken into account. 4. Where a period of insurance or residence other than an equivalent period completed under the legislation of a Member State coincides with an equivalent period on the basis of the legislation of another Member State, only the period other than an equivalent period shall be taken into account. 5. Any period regarded as equivalent under the legislation of two or more Member States shall be taken into account only by the institution of the Member State to whose legislation the person concerned was last compulsorily subject before that period. In the event that the person concerned was not compulsorily subject to the legislation of a Member State before that period, the latter shall be taken into account by the institution of the Member State to whose legislation the person concerned was compulsorily subject for the first time after that period. 6. In the event that the time in which certain periods of insurance or residence were completed under the legislation of a Member State cannot be determined precisely, it shall be presumed that these periods do not overlap with periods of insurance or residence completed under the legislation of another Member State, and account shall be taken thereof, where advantageous to the person concerned, insofar as they can reasonably be taken into consideration. Article 13 Rules for conversion of periods 1. Where periods completed under the legislation of a Member State are expressed in units different from those provided for by the legislation of another Member State, the conversion needed for the purpose of aggregation under Article 6 of the basic Regulation shall be carried out under the following rules: (a) the period to be used as the basis for the conversion shall be that communicated by the institution of the Member State under whose legislation the period was completed; (b) in the case of schemes where the periods are expressed in days the conversion from days to other units, and vice versa, as well as between different schemes based on days shall be calculated according to the following table: Scheme based on 1 day corresponds to 1 week corresponds to 1 month corresponds to 1 quarter corresponds to Maximum of days in one calendar year 5 days 9 hours 5 days 22 days 66 days 264 days 6 days 8 hours 6 days 26 days 78 days 312 days 7 days 6 hours 7 days 30 days 90 days 360 days (c) in the case of schemes where the periods are expressed in units other than days, (i) three months or 13 weeks shall be equivalent to one quarter, and vice versa; (ii) one year shall be equivalent to four quarters, 12 months or 52 weeks, and vice versa; (iii) for the conversion of weeks into months, and vice versa, weeks and months shall be converted into days in accordance with the conversion rules for the schemes based on six days in the table in point (b); (d) in the case of periods expressed in fractions, those figures shall be converted into the next smaller integer unit applying the rules laid down in points (b) and (c). Fractions of years shall be converted into months unless the scheme involved is based on quarters; (e) if the conversion under this paragraph results in a fraction of a unit, the next higher integer unit shall be taken as the result of the conversion under this paragraph. 2. The application of paragraph 1 shall not have the effect of producing, for the total sum of the periods completed during one calendar year, a total exceeding the number of days indicated in the last column in the table in paragraph 1(b), 52 weeks, 12 months or four quarters. If the periods to be converted correspond to the maximum annual amount of periods under the legislation of the Member State in which they have been completed, the application of paragraph 1 shall not result within one calendar year in periods that are shorter than the possible maximum annual amount of periods provided under the legislation concerned. 3. The conversion shall be carried out either in one single operation covering all those periods which were communicated as an aggregate, or for each year, if the periods were communicated on a year-by-year basis. 4. Where an institution communicates periods expressed in days, it shall at the same time indicate whether the scheme it administers is based on five days, six days or seven days. TITLE II DETERMINATION OF THE LEGISLATION APPLICABLE Article 14 Details relating to Articles 12 and 13 of the basic Regulation 1. For the purposes of the application of Article 12(1) of the basic Regulation, a \u2018person who pursues an activity as an employed person in a Member State on behalf of an employer which normally carries out its activities there and who is posted by that employer to another Member State\u2019 shall include a person who is recruited with a view to being posted to another Member State, provided that, immediately before the start of his employment, the person concerned is already subject to the legislation of the Member State in which his employer is established. 2. For the purposes of the application of Article 12(1) of the basic Regulation, the words \u2018which normally carries out its activities there\u2019 shall refer to an employer that ordinarily performs substantial activities, other than purely internal management activities, in the territory of the Member State in which it is established, taking account of all criteria characterising the activities carried out by the undertaking in question. The relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out. 3. For the purposes of the application of Article 12(2) of the basic Regulation, the words \u2018who normally pursues an activity as a self-employed person\u2019 shall refer to a person who habitually carries out substantial activities in the territory of the Member State in which he is established. In particular, that person must have already pursued his activity for some time before the date when he wishes to take advantage of the provisions of that Article and, during any period of temporary activity in another Member State, must continue to fulfil, in the Member State where he is established, the requirements for the pursuit of his activity in order to be able to pursue it on his return. 4. For the purposes of the application of Article 12(2) of the basic Regulation, the criterion for determining whether the activity that a self-employed person goes to pursue in another Member State is \u2018similar\u2019 to the self-employed activity normally pursued shall be that of the actual nature of the activity, rather than of the designation of employed or self-employed activity that may be given to this activity by the other Member State. 5. For the purposes of the application of Article 13(1) of the basic Regulation a person who \u2018normally pursues an activity as an employed person in two or more Member States\u2019 shall refer, in particular, to a person who: (a) while maintaining an activity in one Member State, simultaneously exercises a separate activity in one or more other Member States, irrespective of the duration or nature of that separate activity; (b) continuously pursues alternating activities, with the exception of marginal activities, in two or more Member States, irrespective of the frequency or regularity of the alternation. 6. For the purposes of the application of Article 13(2) of the basic Regulation, a person who \u2018normally pursues an activity as a self-employed person in two or more Member States\u2019 shall refer, in particular, to a person who simultaneously or in alternation pursues one or more separate self-employed activities, irrespective of the nature of those activities, in two or more Member States. 7. For the purpose of distinguishing the activities under paragraphs 5 and 6 from the situations described in Article 12(1) and (2) of the basic Regulation, the duration of the activity in one or more other Member States (whether it is permanent or of an ad hoc or temporary nature) shall be decisive. For these purposes, an overall assessment shall be made of all the relevant facts including, in particular, in the case of an employed person, the place of work as defined in the employment contract. 8. For the purposes of the application of Article 13(1) and (2) of the basic Regulation, a \u2018substantial part of employed or self-employed activity\u2019 pursued in a Member State shall mean a quantitatively substantial part of all the activities of the employed or self-employed person pursued there, without this necessarily being the major part of those activities. To determine whether a substantial part of the activities is pursued in a Member State, the following indicative criteria shall be taken into account: (a) in the case of an employed activity, the working time and/or the remuneration; and (b) in the case of a self-employed activity, the turnover, working time, number of services rendered and/or income. In the framework of an overall assessment, a share of less than 25 % in respect of the criteria mentioned above shall be an indicator that a substantial part of the activities is not being pursued in the relevant Member State. 9. For the purposes of the application of Article 13(2)(b) of the basic Regulation, the \u2018centre of interest\u2019 of the activities of a self-employed person shall be determined by taking account of all the aspects of that person\u2019s occupational activities, notably the place where the person\u2019s fixed and permanent place of business is located, the habitual nature or the duration of the activities pursued, the number of services rendered, and the intention of the person concerned as revealed by all the circumstances. 10. For the determination of the applicable legislation under paragraphs 8 and 9, the institutions concerned shall take into account the situation projected for the following 12 calendar months. 11. If a person pursues his activity as an employed person in two or more Member States on behalf of an employer established outside the territory of the Union, and if this person resides in a Member State without pursuing substantial activity there, he shall be subject to the legislation of the Member State of residence. Article 15 Procedures for the application of Article 11(3)(b) and (d), Article 11(4) and Article 12 of the basic Regulation (on the provision of information to the institutions concerned) 1. Unless otherwise provided for by Article 16 of the implementing Regulation, where a person pursues his activity in a Member State other than the Member State competent under Title II of the basic Regulation, the employer or, in the case of a person who does not pursue an activity as an employed person, the person concerned shall inform the competent institution of the Member State whose legislation is applicable thereof, whenever possible in advance. That institution shall without delay make information concerning the legislation applicable to the person concerned, pursuant to Article 11(3)(b) or Article 12 of the basic Regulation, available to the person concerned and to the institution designated by the competent authority of the Member State in which the activity is pursued. 2. Paragraph 1 shall apply mutatis mutandis to persons covered by Article 11(3)(d) of the basic Regulation. 3. An employer within the meaning of Article 11(4) of the basic Regulation who has an employee on board a vessel flying the flag of another Member State shall inform the competent institution of the Member State whose legislation is applicable thereof whenever possible in advance. That institution shall, without delay, make information concerning the legislation applicable to the person concerned, pursuant to Article 11(4) of the basic Regulation, available to the institution designated by the competent authority of the Member State whose flag, the vessel on which the employee is to perform the activity, is flying. Article 16 Procedure for the application of Article 13 of the basic Regulation 1. A person who pursues activities in two or more Member States shall inform the institution designated by the competent authority of the Member State of residence thereof. 2. The designated institution of the place of residence shall without delay determine the legislation applicable to the person concerned, having regard to Article 13 of the basic Regulation and Article 14 of the implementing Regulation. That initial determination shall be provisional. The institution shall inform the designated institutions of each Member State in which an activity is pursued of its provisional determination. 3. The provisional determination of the applicable legislation, as provided for in paragraph 2, shall become definitive within two months of the institutions designated by the competent authorities of the Member States concerned being informed of it, in accordance with paragraph 2, unless the legislation has already been definitively determined on the basis of paragraph 4, or at least one of the institutions concerned informs the institution designated by the competent authority of the Member State of residence by the end of this two-month period that it cannot yet accept the determination or that it takes a different view on this. 4. Where uncertainty about the determination of the applicable legislation requires contacts between the institutions or authorities of two or more Member States, at the request of one or more of the institutions designated by the competent authorities of the Member States concerned or of the competent authorities themselves, the legislation applicable to the person concerned shall be determined by common agreement, having regard to Article 13 of the basic Regulation and the relevant provisions of Article 14 of the implementing Regulation. Where there is a difference of views between the institutions or competent authorities concerned, those bodies shall seek agreement in accordance with the conditions set out above and Article 6 of the implementing Regulation shall apply. 5. The competent institution of the Member State whose legislation is determined to be applicable either provisionally or definitively shall without delay inform the person concerned. 6. If the person concerned fails to provide the information referred to in paragraph 1, this Article shall be applied at the initiative of the institution designated by the competent authority of the Member State of residence as soon as it is appraised of that person\u2019s situation, possibly via another institution concerned. Article 17 Procedure for the application of Article 15 of the basic Regulation Contract staff of the European Communities shall exercise the right of option provided for in Article 15 of the basic Regulation when the employment contract is concluded. The authority empowered to conclude the contract shall inform the designated institution of the Member State for whose legislation the contract staff member of the European Communities has opted. Article 18 Procedure for the application of Article 16 of the basic Regulation A request by the employer or the person concerned for exceptions to Articles 11 to 15 of the basic Regulation shall be submitted, whenever possible in advance, to the competent authority or the body designated by the authority of the Member State, whose legislation the employee or person concerned requests be applied. Article 19 Provision of information to persons concerned and employers 1. The competent institution of the Member State whose legislation becomes applicable pursuant to Title II of the basic Regulation shall inform the person concerned and, where appropriate, his employer(s) of the obligations laid down in that legislation. It shall provide them with the necessary assistance to complete the formalities required by that legislation. 2. At the request of the person concerned or of the employer, the competent institution of the Member State whose legislation is applicable pursuant to Title II of the basic Regulation shall provide an attestation that such legislation is applicable and shall indicate, where appropriate, until what date and under what conditions. Article 20 Cooperation between institutions 1. The relevant institutions shall communicate to the competent institution of the Member State whose legislation is applicable to a person pursuant to Title II of the basic Regulation the necessary information required to establish the date on which that legislation becomes applicable and the contributions which that person and his employer(s) are liable to pay under that legislation. 2. The competent institution of the Member State whose legislation becomes applicable to a person pursuant to Title II of the basic Regulation shall make the information indicating the date on which the application of that legislation takes effect available to the institution designated by the competent authority of the Member State to whose legislation that person was last subject. Article 21 Obligations of the employer 1. An employer who has his registered office or place of business outside the competent Member State shall fulfil all the obligations laid down by the legislation applicable to his employees, notably the obligation to pay the contributions provided for by that legislation, as if he had his registered office or place of business in the competent Member State. 2. An employer who does not have a place of business in the Member State whose legislation is applicable and the employee may agree that the latter may fulfil the employer\u2019s obligations on its behalf as regards the payment of contributions without prejudice to the employer\u2019s underlying obligations. The employer shall send notice of such an arrangement to the competent institution of that Member State. TITLE III SPECIAL PROVISIONS CONCERNING THE VARIOUS CATEGORIES OF BENEFITS CHAPTER I Sickness, maternity and equivalent paternity benefits Article 22 General implementing provisions 1. The competent authorities or institutions shall ensure that any necessary information is made available to insured persons regarding the procedures and conditions for the granting of benefits in kind where such benefits are received in the territory of a Member State other than that of the competent institution. 2. Notwithstanding Article 5(a) of the basic Regulation, a Member State may become responsible for the cost of benefits in accordance with Article 22 of the basic Regulation only if, either the insured person has made a claim for a pension under the legislation of that Member State, or in accordance with Articles 23 to 30 of the basic Regulation, he receives a pension under the legislation of that Member State. Article 23 Regime applicable in the event of the existence of more than one regime in the Member State of residence or stay If the legislation of the Member State of residence or stay comprises more than one scheme of sickness, maternity and paternity insurance for more than one category of insured persons, the provisions applicable under Articles 17, 19(1), 20, 22, 24 and 26 of the basic Regulation shall be those of the legislation on the general scheme for employed persons. Article 24 Residence in a Member State other than the competent Member State 1. For the purposes of the application of Article 17 of the basic Regulation, the insured person and/or members of his family shall be obliged to register with the institution of the place of residence. Their right to benefits in kind in the Member State of residence shall be certified by a document issued by the competent institution upon request of the insured person or upon request of the institution of the place of residence. 2. The document referred to in paragraph 1 shall remain valid until the competent institution informs the institution of the place of residence of its cancellation. The institution of the place of residence shall inform the competent institution of any registration under paragraph 1 and of any change or cancellation of that registration. 3. This Article shall apply mutatis mutandis to the persons referred to in Articles 22, 24, 25 and 26 of the basic Regulation. Article 25 Stay in a Member State other than the competent Member State 1. For the purposes of the application of Article 19 of the basic Regulation, the insured person shall present to the health care provider in the Member State of stay a document issued by the competent institution indicating his entitlement to benefits in kind. If the insured person does not have such a document, the institution of the place of stay, upon request or if otherwise necessary, shall contact the competent institution in order to obtain one. 2. That document shall indicate that the insured person is entitled to benefits in kind under the conditions laid down in Article 19 of the basic Regulation on the same terms as those applicable to persons insured under the legislation of the Member State of stay. 3. The benefits in kind referred to in Article 19(1) of the basic Regulation shall refer to the benefits in kind which are provided in the Member State of stay, in accordance with its legislation, and which become necessary on medical grounds with a view to preventing an insured person from being forced to return, before the end of the planned duration of stay, to the competent Member State to obtain the necessary treatment. 4. If the insured person has actually borne the costs of all or part of the benefits in kind provided within the framework of Article 19 of the basic Regulation and if the legislation applied by the institution of the place of stay enables reimbursement of those costs to an insured person, he may send an application for reimbursement to the institution of the place of stay. In that case, that institution shall reimburse directly to that person the amount of the costs corresponding to those benefits within the limits of and under the conditions of the reimbursement rates laid down in its legislation. 5. If the reimbursement of such costs has not been requested directly from the institution of the place of stay, the costs incurred shall be reimbursed to the person concerned by the competent institution in accordance with the reimbursement rates administered by the institution of the place of stay or the amounts which would have been subject to reimbursement to the institution of the place of stay, if Article 62 of the implementing Regulation had applied in the case concerned. The institution of the place of stay shall provide the competent institution, upon request, with all necessary information about these rates or amounts. 6. By way of derogation from paragraph 5, the competent institution may undertake the reimbursement of the costs incurred within the limits of and under the conditions of the reimbursement rates laid down in its legislation, provided that the insured person has agreed to this provision being applied to him/her. 7. If the legislation of the Member State of stay does not provide for reimbursement pursuant to paragraphs 4 and 5 in the case concerned, the competent institution may reimburse the costs within the limits of and under the conditions of the reimbursement rates laid down in its legislation, without the agreement of the insured person. 8. The reimbursement to the insured person shall not, in any event, exceed the amount of costs actually incurred by him/her. 9. In the case of substantial expenditure, the competent institution may pay the insured person an appropriate advance as soon as that person submits the application for reimbursement to it. 10. Paragraphs 1 to 9 shall apply mutatis mutandis to the members of the family of the insured person. Article 26 Scheduled treatment 1. For the purposes of the application of Article 20(1) of the basic Regulation, the insured person shall present a document issued by the competent institution to the institution of the place of stay. For the purposes of this Article, the competent institution shall mean the institution which bears the cost of the scheduled treatment; in the cases referred to in Article 20(4) and 27(5) of the basic Regulation, in which the benefits in kind provided in the Member State of residence are reimbursed on the basis of fixed amounts, the competent institution shall mean the institution of the place of residence. 2. If an insured person does not reside in the competent Member State, he shall request authorisation from the institution of the place of residence, which shall forward it to the competent institution without delay. In that event, the institution of the place of residence shall certify in a statement whether the conditions set out in the second sentence of Article 20(2) of the basic Regulation are met in the Member State of residence. The competent institution may refuse to grant the requested authorisation only if, in accordance with the assessment of the institution of the place of residence, the conditions set out in the second sentence of Article 20(2) of the basic Regulation are not met in the Member State of residence of the insured person, or if the same treatment can be provided in the competent Member State itself, within a time-limit which is medically justifiable, taking into account the current state of health and the probable course of illness of the person concerned. The competent institution shall inform the institution of the place of residence of its decision. In the absence of a reply within the deadlines set by its national legislation, the authorisation shall be considered to have been granted by the competent institution. 3. If an insured person who does not reside in the competent Member State is in need of urgent vitally necessary treatment, and the authorisation cannot be refused in accordance with the second sentence of Article 20(2) of the basic Regulation, the authorisation shall be granted by the institution of the place of residence on behalf of the competent institution, which shall be immediately informed by the institution of the place of residence. The competent institution shall accept the findings and the treatment options of the doctors approved by the institution of the place of residence that issues the authorisation, concerning the need for urgent vitally necessary treatment. 4. At any time during the procedure granting the authorisation, the competent institution shall retain the right to have the insured person examined by a doctor of its own choice in the Member State of stay or residence. 5. The institution of the place of stay shall, without prejudice to any decision regarding authorisation, inform the competent institution if it appears medically appropriate to supplement the treatment covered by the existing authorisation. 6. Without prejudice to paragraph 7, Article 25(4) and (5) of the implementing Regulation shall apply mutatis mutandis. 7. If the insured person has actually borne all or part of the costs for the authorised medical treatment him or herself and the costs which the competent institution is obliged to reimburse to the institution of the place of stay or to the insured person according to paragraph 6 (actual cost) are lower than the costs which it would have had to assume for the same treatment in the competent Member State (notional cost), the competent institution shall reimburse, upon request, the cost of treatment incurred by the insured person up to the amount by which the notional cost exceeds the actual cost. The reimbursed sum may not, however, exceed the costs actually incurred by the insured person and may take account of the amount which the insured person would have had to pay if the treatment had been delivered in the competent Member State. 8. Where the national legislation of the competent institution provides for the reimbursement of the costs of travel and stay which are inseparable from the treatment of the insured person, such costs for the person concerned and, if necessary, for a person who must accompany him/her, shall be assumed by this institution when an authorisation is granted in the case of treatment in another Member State. 9. Paragraphs 1 to 8 shall apply mutatis mutandis to the members of the family of the insured persons. Article 27 Cash benefits relating to incapacity for work in the event of stay or residence in a Member State other than the competent Member State 1. If the legislation of the competent Member State requires that the insured person presents a certificate in order to be entitled to cash benefits relating to incapacity for work pursuant to Article 21(1) of the basic Regulation, the insured person shall ask the doctor of the Member State of residence who established his state of health to certify his incapacity for work and its probable duration. 2. The insured person shall send the certificate to the competent institution within the time limit laid down by the legislation of the competent Member State. 3. Where the doctors providing treatment in the Member State of residence do not issue certificates of incapacity for work, and where such certificates are required under the legislation of the competent Member State, the person concerned shall apply directly to the institution of the place of residence. That institution shall immediately arrange for a medical assessment of the person\u2019s incapacity for work and for the certificate referred to in paragraph 1 to be drawn up. The certificate shall be forwarded to the competent institution forthwith. 4. The forwarding of the document referred to in paragraphs 1, 2 and 3 shall not exempt the insured person from fulfilling the obligations provided for by the applicable legislation, in particular with regard to his employer. Where appropriate, the employer and/or the competent institution may call upon the employee to participate in activities designed to promote and assist his return to employment. 5. At the request of the competent institution, the institution of the place of residence shall carry out any necessary administrative checks or medical examinations of the person concerned in accordance with the legislation applied by this latter institution. The report of the examining doctor concerning, in particular, the probable duration of the incapacity for work, shall be forwarded without delay by the institution of the place of residence to the competent institution. 6. The competent institution shall reserve the right to have the insured person examined by a doctor of its choice. 7. Without prejudice to the second sentence of Article 21(1) of the basic Regulation, the competent institution shall pay the cash benefits directly to the person concerned and shall, where necessary, inform the institution of the place of residence thereof. 8. For the purposes of the application of Article 21(1) of the basic Regulation, the particulars of the certificate of incapacity for work of an insured person drawn up in another Member State on the basis of the medical findings of the examining doctor or institution shall have the same legal value as a certificate drawn up in the competent Member State. 9. If the competent institution refuses the cash benefits, it shall notify its decision to the insured person and at the same time to the institution of the place of residence. 10. Paragraphs 1 to 9 shall apply mutatis mutandis when the insured person stays in a Member State other than the competent Member State. Article 28 Long-term care benefits in cash in the event of stay or residence in a Member State other than the competent Member State 1. In order to be entitled to long-term care benefits in cash pursuant to Article 21(1) of the basic Regulation, the insured person shall apply to the competent institution. The competent institution shall, where necessary, inform the institution of the place of residence thereof. 2. At the request of the competent institution, the institution of the place of residence shall examine the condition of the insured person with respect to his need for long-term care. The competent institution shall give the institution of the place of residence all the information necessary for such an examination. 3. In order to determine the degree of need for long-term care, the competent institution shall have the right to have the insured person examined by a doctor or any other expert of its choice. 4. Article 27(7) of the implementing Regulation shall apply mutatis mutandis. 5. Paragraphs 1 to 4 shall apply mutatis mutandis when the insured person stays in a Member State other than the competent Member State. 6. Paragraphs 1 to 5 shall apply mutatis mutandis to the members of the family of the insured person. Article 29 Application of Article 28 of the basic Regulation If the Member State where the former frontier worker last pursued his activity is no longer the competent Member State, and the former frontier worker or a member of his family travels there with the purpose of receiving benefits in kind pursuant to Article 28 of the basic Regulation, he shall submit to the institution of the place of stay a document issued by the competent institution. Article 30 Contributions by pensioners If a person receives a pension from more than one Member State, the amount of contributions deducted from all the pensions paid shall under no circumstances be greater than the amount deducted in respect of a person who receives the same amount of pension from the competent Member State. Article 31 Application of Article 34 of the basic Regulation 1. The competent institution shall inform the person concerned of the provision contained in Article 34 of the basic Regulation regarding the prevention of overlapping of benefits. The application of such rules shall ensure that the person not residing in the competent Member State is entitled to benefits of at least the same total amount or value as those to which he would be entitled if he resided in that Member State. 2. The competent institution shall also inform the institution of the place of residence or stay about the payment of long-term care cash benefits where the legislation applied by the latter institution provides for the long-term care benefits in kind included in the list referred to in Article 34(2) of the basic Regulation. 3. Having received the information provided for in paragraph 2, the institution of the place of residence or stay shall without delay inform the competent institution of any long-term care benefit in kind intended for the same purpose granted under its legislation to the person concerned and of the rate of reimbursement applicable thereto. 4. The Administrative Commission shall lay down implementing measures for this Article where necessary. Article 32 Special implementing measures 1. When a person or a group of persons are exempted upon request from compulsory sickness insurance and such persons are thus not covered by a sickness insurance scheme to which the basic Regulation applies, the institution of another Member State shall not, solely because of this exemption, become responsible for bearing the costs of benefits in kind or in cash provided to such persons or to a member of their family under Title III, Chapter I, of the basic Regulation. 2. For the Member States referred to in Annex 2, the provisions of Title III, Chapter I, of the basic Regulation relating to benefits in kind shall apply to persons entitled to benefits in kind solely on the basis of a special scheme for civil servants only to the extent specified therein. The institution of another Member State shall not, on those grounds alone, become responsible for bearing the costs of benefits in kind or in cash provided to those persons or to members of their family. 3. When the persons referred to in paragraphs 1 and 2 and the members of their families reside in a Member State where the right to receive benefits in kind is not subject to conditions of insurance, or of activity as an employed or self-employed person, they shall be liable to pay the full costs of benefits in kind provided in their country of residence. CHAPTER II Benefits in respect of accidents at work and occupational diseases Article 33 Right to benefits in kind and in cash in the event of residence or stay in a Member State other than the competent Member State 1. For the purposes of the application of Article 36 of the basic Regulation, the procedures laid down in Articles 24 to 27 of the implementing Regulation shall apply mutatis mutandis. 2. When providing special benefits in kind in connection with accidents at work and occupational diseases under the national legislation of the Member State of stay or residence, the institution of that Member State shall without delay inform the competent institution. Article 34 Procedure in the event of an accident at work or occupational disease which occurs in a Member State other than the competent Member State 1. If an accident at work occurs or an occupational disease is diagnosed for the first time in a Member State other than the competent Member State, the declaration or notification of the accident at work or the occupational disease, where the declaration or notification exists under national legislation, shall be carried out in accordance with the legislation of the competent Member State, without prejudice, where appropriate, to any other applicable legal provisions in force in the Member State in which the accident at work occurred or in which the first medical diagnosis of the occupational disease was made, which remain applicable in such cases. The declaration or notification shall be addressed to the competent institution. 2. The institution of the Member State in the territory of which the accident at work occurred or in which the occupational disease was first diagnosed, shall notify the competent institution of medical certificates drawn up in the territory of that Member State. 3. Where, as a result of an accident while travelling to or from work which occurs in the territory of a Member State other than the competent Member State, an inquiry is necessary in the territory of the first Member State in order to determine any entitlement to relevant benefits, a person may be appointed for that purpose by the competent institution, which shall inform the authorities of that Member State. The institutions shall cooperate with each other in order to assess all relevant information and to consult the reports and any other documents relating to the accident. 4. Following treatment, a detailed report accompanied by medical certificates relating to the permanent consequences of the accident or disease, in particular the injured person\u2019s present state and the recovery or stabilisation of injuries, shall be sent upon request of the competent institution. The relevant fees shall be paid by the institution of the place of residence or of stay, where appropriate, at the rate applied by that institution to the charge of the competent institution. 5. At the request of the institution of the place of residence or stay, where appropriate, the competent institution shall notify it of the decision setting the date for the recovery or stabilisation of injuries and, where appropriate, the decision concerning the granting of a pension. Article 35 Disputes concerning the occupational nature of the accident or disease 1. Where the competent institution disputes the application of the legislation relating to accidents at work or occupational diseases under Article 36(2) of the basic Regulation, it shall without delay inform the institution of the place of residence or stay which provided the benefits in kind, which will then be considered as sickness insurance benefits. 2. When a final decision has been taken on that subject, the competent institution shall without delay inform the institution of the place of residence or stay which provided the benefits in kind. Where an accident at work or occupational disease is not established, benefits in kind shall continue to be provided as sickness benefits if the person concerned is entitled to them. Where an accident at work or occupational disease is established, sickness benefits in kind provided to the person concerned shall be considered as accident at work or occupational disease benefits from the date on which the accident at work occurred or the occupational disease was first medically diagnosed. 3. The second subparagraph of Article 6(5) of the implementing Regulation shall apply mutatis mutandis. Article 36 Procedure in the event of exposure to the risk of an occupational disease in more than one Member State 1. In the case referred to in Article 38 of the basic Regulation, the declaration or notification of the occupational disease shall be sent to the competent institution for occupational diseases of the last Member State under the legislation of which the person concerned pursued an activity likely to cause that disease. When the institution to which the declaration or notification was sent establishes that an activity likely to cause the occupational disease in question was last pursued under the legislation of another Member State, it shall send the declaration or notification and all accompanying certificates to the equivalent institution in that Member State. 2. Where the institution of the last Member State under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question establishes that the person concerned or his survivors do not meet the requirements of that legislation, inter alia, because the person concerned had never pursued in that Member State an activity which caused the occupational disease or because that Member State does not recognise the occupational nature of the disease, that institution shall forward without delay the declaration or notification and all accompanying certificates, including the findings and reports of medical examinations performed by the first institution to the institution of the previous Member State under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question. 3. Where appropriate, the institutions shall reiterate the procedure set out in paragraph 2 going back as far as the equivalent institution in the Member State under whose legislation the person concerned first pursued an activity likely to cause the occupational disease in question. Article 37 Exchange of information between institutions and advance payments in the event of an appeal against rejection 1. In the event of an appeal against a decision to refuse benefits taken by the institution of one of the Member States under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question, that institution shall inform the institution to which the declaration or notification was sent, in accordance with the procedure provided for in Article 36(2) of the implementing Regulation, and shall subsequently inform it when a final decision is reached. 2. Where a person is entitled to benefits under the legislation applied by the institution to which the declaration or notification was sent, that institution shall make the advance payments, the amount of which shall be determined, where appropriate, after consulting the institution which made the decision against which the appeal was lodged, and in such a way that overpayments are avoided. The latter institution shall reimburse the advance payments made if, as a result of the appeal, it is obliged to provide those benefits. That amount will then be deducted from the benefits due to the person concerned, in accordance with the procedure provided for in Articles 72 and 73 of the implementing Regulation. 3. The second subparagraph of Article 6(5) of the implementing Regulation shall apply mutatis mutandis. Article 38 Aggravation of an occupational disease In the cases covered by Article 39 of the basic Regulation, the claimant must provide the institution in the Member State from which he is claiming entitlement to benefits with details concerning benefits previously granted for the occupational disease in question. That institution may contact any other previously competent institution in order to obtain the information it considers necessary. Article 39 Assessment of the degree of incapacity in the event of occupational accidents or diseases which occurred previously or subsequently Where a previous or subsequent incapacity for work was caused by an accident which occurred when the person concerned was subject to the legislation of a Member State which makes no distinction according to the origin of the incapacity to work, the competent institution or the body designated by the competent authority of the Member State in question shall: (a) upon request by the competent institution of another Member State, provide information concerning the degree of the previous or subsequent incapacity for work, and where possible, information making it possible to determine whether the incapacity is the result of an accident at work within the meaning of the legislation applied by the institution in the other Member State; (b) take into account the degree of incapacity caused by these previous or subsequent cases when determining the right to benefits and the amount, in accordance with the applicable legislation. Article 40 Submission and investigation of claims for pensions or supplementary allowances In order to receive a pension or supplementary allowance under the legislation of a Member State, the person concerned or his survivors residing in the territory of another Member State shall submit, where appropriate, a claim either to the competent institution or to the institution of the place of residence, which shall send it to the competent institution. The claim shall contain the information required under the legislation applied by the competent institution. Article 41 Special implementing measures 1. In relation to the Member States referred to in Annex 2, the provisions of Title III, Chapter 2 of the basic Regulation relating to benefits in kind shall apply to persons entitled to benefits in kind solely on the basis of a special scheme for civil servants, and only to the extent specified therein. 2. Article 32(2) second subparagraph and Article 32(3) of the implementing Regulation shall apply mutatis mutandis. CHAPTER III Death grants Article 42 Claim for death grants For the purposes of applying Articles 42 and 43 of the basic Regulation, the claim for death grants shall be sent either to the competent institution or to the institution of the claimant\u2019s place of residence, which shall send it to the competent institution. The claim shall contain the information required under the legislation applied by the competent institution. CHAPTER IV Invalidity benefits and old-age and survivors\u2019 pensions Article 43 Additional provisions for the calculation of benefit 1. For the purposes of calculating the theoretical amount and the actual amount of the benefit in accordance with Article 52(1)(b) of the basic Regulation, the rules provided for in Article 12(3), (4), (5) and (6) of the implementing Regulation shall apply. 2. Where periods of voluntary or optional continued insurance have not been taken into account under Article 12(3) of the implementing Regulation, the institution of the Member State under whose legislation those periods were completed shall calculate the amount corresponding to those periods under the legislation it applies. The actual amount of the benefit, calculated in accordance with Article 52(1)(b) of the basic Regulation, shall be increased by the amount corresponding to periods of voluntary or optional continued insurance. 3. The institution of each Member State shall calculate, under the legislation it applies, the amount due corresponding to periods of voluntary or optional continued insurance which, under Article 53(3)(c) of the basic Regulation, shall not be subject to another Member State\u2019s rules relating to withdrawal, reduction or suspension. Where the legislation applied by the competent institution does not allow it to determine this amount directly, on the grounds that that legislation allocates different values to insurance periods, a notional amount may be established. The Administrative Commission shall lay down the detailed arrangements for the determination of that notional amount. Article 44 Taking into account of child raising-periods 1. For the purposes of this Article, \u2018child-raising period\u2019 refers to any period which is credited under the pension legislation of a Member State or which provides a supplement to a pension explicitly for the reason that a person has raised a child, irrespective of the method used to calculate those periods and whether they accrue during the time of child-raising or are acknowledged retroactively. 2. Where, under the legislation of the Member State which is competent under Title II of the basic Regulation, no child-raising period is taken into account, the institution of the Member State whose legislation, according to Title II of the basic Regulation, was applicable to the person concerned on the grounds that he or she was pursuing an activity as an employed or self-employed person at the date when, under that legislation, the child-raising period started to be taken into account for the child concerned, shall remain responsible for taking into account that period as a child-raising period under its own legislation, as if such child-raising took place in its own territory. 3. Paragraph 2 shall not apply if the person concerned is, or becomes, subject to the legislation of another Member State due to the pursuit of an employed or self-employed activity. Article 45 Claim for benefits 1. In order to receive benefits under type A legislation under Article 44(2) of the basic Regulation, the claimant shall submit a claim to the institution of the Member State, whose legislation was applicable at the time when the incapacity for work occurred followed by invalidity or the aggravation of such invalidity, or to the institution of the place of residence, which shall forward the claim to the first institution. 2. If sickness benefits in cash have been awarded, the expiry date of the period for awarding these benefits shall, where appropriate, be considered as the date of submission of the pension claim. 3. In the case referred to in Article 47(1) of the basic Regulation, the institution with which the person concerned was last insured shall inform the institution which initially paid the benefits of the amount and the date of commencement of the benefits under the applicable legislation. From that date benefits due before aggravation of the invalidity shall be withdrawn or reduced to the supplement referred to in Article 47(2) of the basic Regulation. 4. In situations other than those referred to in paragraph 1, the claimant shall submit a claim to the institution of his place of residence or to the institution of the last Member State whose legislation was applicable. If the person concerned was not, at any time, subject to the legislation applied by the institution of the place of residence, that institution shall forward the claim to the institution of the last Member State whose legislation was applicable. 5. The date of submission of the claim shall apply in all the institutions concerned. 6. By way of derogation from paragraph 5, if the claimant does not, despite having been asked to do so, notify the fact that he has been employed or has resided in other Member States, the date on which the claimant completes his initial claim or submits a new claim for his missing periods of employment or/and residence in a Member State shall be considered as the date of submission of the claim to the institution applying the legislation in question, subject to more favourable provisions of that legislation. Article 46 Certificates and information to be submitted with the claim by the claimant 1. The claim shall be submitted by the claimant in accordance with the provisions of the legislation applied by the institution referred to in Article 45(1) or (4) of the implementing Regulation and be accompanied by the supporting documents required by that legislation. In particular, the claimant shall supply all available relevant information and supporting documents relating to periods of insurance (institutions, identification numbers), employment (employers) or self-employment (nature and place of activity) and residence (addresses) which may have been completed under other legislation, as well as the length of those periods. 2. Where, in accordance with Article 50(1) of the basic Regulation, the claimant requests deferment of the award of old-age benefits under the legislation of one or more Member States, he shall state that in his claim and specify under which legislation the deferment is requested. In order to enable the claimant to exercise that right, the institutions concerned shall, upon the request of the claimant, notify him of all the information available to them so that he can assess the consequences of concurrent or successive awards of benefits which he might claim. 3. Should the claimant withdraw a claim for benefits provided for under the legislation of a particular Member State, that withdrawal shall not be considered as a concurrent withdrawal of claims for benefits under the legislation of other Member States. Article 47 Investigation of claims by the institutions concerned 1. The institution to which the claim for benefits is submitted or forwarded in accordance with Article 45(1) or (4) of the implementing Regulation shall be referred to hereinafter as the \u2018contact institution\u2019. The institution of the place of residence shall not be referred to as the contact institution if the person concerned has not, at any time, been subject to the legislation which that institution applies. In addition to investigating the claim for benefits under the legislation which it applies, this institution shall, in its capacity as contact institution, promote the exchange of data, the communication of decisions and the operations necessary for the investigation of the claim by the institutions concerned, and supply the claimant, upon request, with any information relevant to the Community aspects of the investigation and keep him/her informed of its progress. 2. In the case referred to in Article 44(3) of the basic Regulation, the contact institution shall send all the documents relating to the person concerned to the institution with which he was previously insured, which shall in turn examine the case. 3. Articles 48 to 52 of the implementing Regulation shall not be applicable to the investigation of claims referred to in Article 44 of the basic Regulation. 4. In situations other than those referred to in paragraph 2, the contact institution shall, without delay, send claims for benefits and all the documents which it has available and, where appropriate, the relevant documents supplied by the claimant to all the institutions in question so that they can all start the investigation of the claim concurrently. The contact institution shall notify the other institutions of periods of insurance or residence subject to its legislation. It shall also indicate which documents shall be submitted at a later date and supplement the claim as soon as possible. 5. Each of the institutions in question shall notify the contact institution and the other institutions in question, as soon as possible, of the periods of insurance or residence subject to their legislation. 6. Each of the institutions in question shall calculate the amount of benefits in accordance with Article 52 of the basic Regulation and shall notify the contact institution and the other institutions concerned of its decision, of the amount of benefits due and of any information required for the purposes of Articles 53 to 55 of the basic Regulation. 7. Should an institution establish, on the basis of the information referred to in paragraphs 4 and 5 of this Article, that Article 46(2) or Article 57(2) or (3) of the basic Regulation is applicable, it shall inform the contact institution and the other institutions concerned. Article 48 Notification of decisions to the claimant 1. Each institution shall notify the claimant of the decision it has taken in accordance with the applicable legislation. Each decision shall specify the remedies and periods allowed for appeals. Once the contact institution has been notified of all decisions taken by each institution, it shall send the claimant and the other institutions concerned a summary of those decisions. A model summary shall be drawn up by the Administrative Commission. The summary shall be sent to the claimant in the language of the institution or, at the request of the claimant, in any language of his choice recognised as an official language of the Community institutions in accordance with Article 290 of the Treaty. 2. Where it appears to the claimant following receipt of the summary that his rights may have been adversely affected by the interaction of decisions taken by two or more institutions, the claimant shall have the right to a review of the decisions by the institutions concerned within the time limits laid down in the respective national legislation. The time limits shall commence on the date of receipt of the summary. The claimant shall be notified of the result of the review in writing. Article 49 Determination of the degree of invalidity 1. Where Article 46(3) of the basic Regulation is applicable, the only institution authorised to take a decision concerning the claimant\u2019s degree of invalidity shall be the contact institution, if the legislation applied by that institution is included in Annex VII to the basic Regulation, or failing that, the institution whose legislation is included in that Annex and to whose legislation the claimant was last subject. It shall take that decision as soon as it can determine whether the conditions for eligibility laid down in the applicable legislation are met, taking into account, where appropriate, Articles 6 and 51 of the basic Regulation. It shall without delay notify the other institutions concerned of that decision. Where the eligibility criteria, other than those relating to the degree of invalidity, laid down in the applicable legislation are not met, taking into account Articles 6 and 51 of the basic Regulation, the contact institution shall without delay inform the competent institution of the last Member State to whose legislation the claimant was subject. The latter institution shall be authorised to take the decision concerning the degree of invalidity of the claimant if the conditions for eligibility laid down in the applicable legislation are met. It shall without delay notify the other institutions concerned of that decision. When determining eligibility, the matter may, if necessary have to be referred back, under the same conditions, to the competent institution in respect of invalidity of the Member State to whose legislation the claimant was first subject. 2. Where Article 46(3) of the basic Regulation is not applicable, each institution shall, in accordance with its legislation, have the possibility of having the claimant examined by a medical doctor or other expert of its choice to determine the degree of invalidity. However, the institution of a Member State shall take into consideration documents, medical reports and administrative information collected by the institution of any other Member State as if they had been drawn up in its own Member State. Article 50 Provisional instalments and advance payment of benefit 1. Notwithstanding Article 7 of the implementing Regulation, any institution which establishes, while investigating a claim for benefits, that the claimant is entitled to an independent benefit under the applicable legislation, in accordance with Article 52(1)(a) of the basic Regulation, shall pay that benefit without delay. That payment shall be considered provisional if the amount might be affected by the result of the claim investigation procedure. 2. Whenever it is evident from the information available that the claimant is entitled to a payment from an institution under Article 52(1)(b) of the basic Regulation, that institution shall make an advance payment, the amount of which shall be as close as possible to the amount which will probably be paid under Article 52(1)(b) of the basic Regulation. 3. Each institution which is obliged to pay the provisional benefits or advance payment under paragraphs 1 or 2 shall inform the claimant without delay, specifically drawing his attention to the provisional nature of the measure and any rights of appeal in accordance with its legislation. Article 51 New calculation of benefits 1. Where there is a new calculation of benefits in accordance with Articles 48(3) and (4), 50(4) and 59(1) of the basic Regulation, Article 50 of the implementing Regulation shall be applicable mutatis mutandis. 2. Where there is a new calculation, withdrawal or suspension of the benefit, the institution which took the decision shall inform the person concerned without delay and shall inform each of the institutions in respect of which the person concerned has an entitlement. Article 52 Measures intended to accelerate the pension calculation process 1. In order to facilitate and accelerate the investigation of claims and the payment of benefits, the institutions to whose legislation a person has been subject shall: (a) exchange with or make available to institutions of other Member States the elements for identifying persons who change from one applicable national legislation to another, and together ensure that those identification elements are retained and correspond, or, failing that, provide those persons with the means to access their identification elements directly; (b) sufficiently in advance of the minimum age for commencing pension rights or before an age to be determined by national legislation, exchange with or make available to the person concerned and to institutions of other Member States information (periods completed or other important elements) on the pension entitlements of persons who have changed from one applicable legislation to another or, failing that, inform those persons of, or provide them with, the means of familiarising themselves with their prospective benefit entitlement. 2. For the purposes of applying paragraph 1, the Administrative Commission shall determine the elements of information to be exchanged or made available and shall establish the appropriate procedures and mechanisms, taking account of the characteristics, administrative and technical organisation, and the technological means at the disposal of national pension schemes. The Administrative Commission shall ensure the implementation of those pension schemes by organising a follow-up to the measures taken and their application. 3. For the purposes of applying paragraph 1, the institution in the first Member State where a person is allocated a Personal Identification Number (PIN) for the purposes of social security administration should be provided with the information referred to in this Article. Article 53 Coordination measures in Member States 1. Without prejudice to Article 51 of the basic Regulation, where national legislation includes rules for determining the institution responsible or the scheme applicable or for designating periods of insurance to a specific scheme, those rules shall be applied, taking into account only periods of insurance completed under the legislation of the Member State concerned. 2. Where national legislation includes rules for the coordination of special schemes for civil servants and the general scheme for employed persons, those rules shall not be affected by the provisions of the basic Regulation and of the implementing Regulation. CHAPTER V Unemployment benefits Article 54 Aggregation of periods and calculation of benefits 1. Article 12(1) of the implementing Regulation shall apply mutatis mutandis to Article 61 of the basic Regulation. Without prejudice to the underlying obligations of the institutions involved, the person concerned may submit to the competent institution a document issued by the institution of the Member State to whose legislation he was subject in respect of his last activity as an employed or self-employed person specifying the periods completed under that legislation. 2. For the purposes of applying Article 62(3) of the basic Regulation, the competent institution of the Member State to whose legislation the person concerned was subject in respect of his last activity as an employed or self-employed person shall, without delay, at the request of the institution of the place of residence, provide it with all the information necessary to calculate unemployment benefits which can be obtained in the Member State of residence, in particular the salary or professional income received. 3. For the purposes of applying Article 62 of the basic Regulation and notwithstanding Article 63 thereof, the competent institution of a Member State whose legislation provides that the calculation of benefits varies with the number of members of the family shall also take into account the members of the family of the person concerned residing in another Member State as if they resided in the competent Member State. This provision shall not apply where, in the Member State of residence of members of the family, another person is entitled to unemployment benefits calculated on the basis of the number of members of the family. Article 55 Conditions and restrictions on the retention of the entitlement to benefits for unemployed persons going to another Member State 1. In order to be covered by Article 64 of the basic Regulation, the unemployed person going to another Member State shall inform the competent institution prior to his departure and request a document certifying that he retains entitlement to benefits under the conditions laid down in Article 64(1)(b) of the basic Regulation. That institution shall inform the person concerned of his obligations and shall provide the abovementioned document which shall include the following information: (a) the date on which the unemployed person ceased to be available to the employment services of the competent State; (b) the period granted in accordance with Article 64(1)(b) of the basic Regulation in order to register as a person seeking work in the Member State to which the unemployed person has gone; (c) the maximum period during which the entitlement to benefits may be retained in accordance with Article 64(1)(c) of the basic Regulation; (d) circumstances likely to affect the entitlement to benefits. 2. The unemployed person shall register as a person seeking work with the employment services of the Member State to which he goes in accordance with Article 64(1)(b) of the basic Regulation and shall provide the document referred to in paragraph 1 to the institution of that Member State. If he has informed the competent institution in accordance with paragraph 1 but fails to provide this document, the institution in the Member State to which the unemployed person has gone shall contact the competent institution in order to obtain the necessary information. 3. The employment services in the Member State to which the unemployed person has gone to seek employment shall inform the unemployed person of his obligations. 4. The institution in the Member State to which the unemployed person has gone shall immediately send a document to the competent institution containing the date on which the unemployed person registered with the employment services and his new address. If, in the period during which the unemployed person retains entitlement to benefits, any circumstance likely to affect the entitlement to benefits arises, the institution in the Member State to which the unemployed person has gone shall send immediately to the competent institution and to the person concerned a document containing the relevant information. At the request of the competent institution, the institution in the Member State to which the unemployed person has gone shall provide relevant information on a monthly basis concerning the follow-up of the unemployed person\u2019s situation, in particular whether the latter is still registered with the employment services and is complying with organised checking procedures. 5. The institution in the Member State to which the unemployed person has gone shall carry out or arrange for checks to be carried out, as if the person concerned were an unemployed person obtaining benefits under its own legislation. Where necessary, it shall immediately inform the competent institution if any circumstances referred to in paragraph 1(d) arise. 6. The competent authorities or competent institutions of two or more Member States may agree amongst themselves specific procedures and time-limits concerning the follow-up of the unemployed person\u2019s situation as well as other measures to facilitate the job-seeking activities of unemployed persons who go to one of those Member States under Article 64 of the basic Regulation. Article 56 Unemployed persons who resided in a Member State other than the competent Member State 1. Where the unemployed person decides, in accordance with Article 65(2) of the basic Regulation, to make him/herself also available to the employment services in the Member State in which he pursued his last activity as an employed or self-employed person by registering there as a person seeking work, he shall inform the institution and employment services of the Member State of his place of residence. At the request of the employment services of the Member State in which the person concerned pursued his last activity as an employed or self-employed person, the employment services in the place of residence shall send the relevant information concerning the unemployed person\u2019s registration and search for employment. 2. Where the legislation applicable in the Member States concerned requires the fulfilment of certain obligations and/or job-seeking activities by the unemployed person, the obligations and/or job-seeking activities by the unemployed person in the Member State of residence shall have priority. The non-fulfilment by the unemployed person of all the obligations and/or job-seeking activities in the Member State in which he pursued his last activity shall not affect the benefits awarded in the Member State of residence. 3. For the purposes of applying Article 65(5)(b) of the basic Regulation, the institution of the Member State to whose legislation the worker was last subject shall inform the institution of the place of residence, when requested to do so by the latter, whether the worker is entitled to benefits under Article 64 of the basic Regulation. Article 57 Provisions for the application of Articles 61, 62, 64 and 65 of the basic Regulation regarding persons covered by a special scheme for civil servants 1. Articles 54 and 55 of the implementing Regulation shall apply mutatis mutandis to persons covered by a special unemployment scheme for civil servants. 2. Article 56 of the implementing Regulation shall not apply to persons covered by a special unemployment scheme for civil servants. An unemployed person who is covered by a special unemployment scheme for civil servants, who is partially or wholly unemployed, and who, during his last employment, was residing in the territory of a Member State other than the competent State, shall receive the benefits under the special unemployment scheme for civil servants in accordance with the provisions of the legislation of the competent Member State as if he were residing in the territory of that Member State. Those benefits shall be provided by the competent institution, at its expense. CHAPTER VI Family benefits Article 58 Priority rules in the event of overlapping For the purposes of applying Article 68(1)(b)(i) and (ii) of the basic Regulation, where the order of priority cannot be established on the basis of the children\u2019s place of residence, each Member State concerned shall calculate the amount of benefits including the children not resident within its own territory. In the event of applying Article 68(1)(b)(i), the competent institution of the Member State whose legislation provides for the highest level of benefits shall pay the full amount of such benefits and be reimbursed half this sum by the competent institution of the other Member State up to the limit of the amount provided for in the legislation of the latter Member State. Article 59 Rules applicable where the applicable legislation and/or the competence to grant family benefits changes 1. Where the applicable legislation and/or the competence to grant family benefits change between Member States during a calendar month, irrespective of the payment dates of family benefits under the legislation of those Member States, the institution which has paid the family benefits by virtue of the legislation under which the benefits have been granted at the beginning of that month shall continue to do so until the end of the month in progress. 2. It shall inform the institution of the other Member State or Member States concerned of the date on which it ceases to pay the family benefits in question. Payment of benefits from the other Member State or Member States concerned shall take effect from that date. Article 60 Procedure for applying Articles 67 and 68 of the basic Regulation 1. The application for family benefits shall be addressed to the competent institution. For the purposes of applying Articles 67 and 68 of the basic Regulation, the situation of the whole family shall be taken into account as if all the persons involved were subject to the legislation of the Member State concerned and residing there, in particular as regards a person\u2019s entitlement to claim such benefits. Where a person entitled to claim the benefits does not exercise his right, an application for family benefits submitted by the other parent, a person treated as a parent, or a person or institution acting as guardian of the child or children, shall be taken into account by the competent institution of the Member State whose legislation is applicable. 2. The institution to which an application is made in accordance with paragraph 1 shall examine the application on the basis of the detailed information supplied by the applicant, taking into account the overall factual and legal situation of the applicant\u2019s family. If that institution concludes that its legislation is applicable by priority right in accordance with Article 68(1) and (2) of the basic Regulation, it shall provide the family benefits according to the legislation it applies. If it appears to that institution that there may be an entitlement to a differential supplement by virtue of the legislation of another Member State in accordance with Article 68(2) of the basic Regulation, that institution shall forward the application, without delay, to the competent institution of the other Member State and inform the person concerned; moreover, it shall inform the institution of the other Member State of its decision on the application and the amount of family benefits paid. 3. Where the institution to which the application is made concludes that its legislation is applicable, but not by priority right in accordance with Article 68(1) and (2) of the basic Regulation, it shall take a provisional decision, without delay, on the priority rules to be applied and shall forward the application, in accordance with Article 68(3) of the basic Regulation, to the institution of the other Member State, and shall also inform the applicant thereof. That institution shall take a position on the provisional decision within two months. If the institution to which the application was forwarded does not take a position within two months of the receipt of the application, the provisional decision referred to above shall apply and the institution shall pay the benefits provided for under its legislation and inform the institution to which the application was made of the amount of benefits paid. 4. Where there is a difference of views between the institutions concerned about which legislation is applicable by priority right, Article 6(2) to (5) of the implementing Regulation shall apply. For this purpose the institution of the place of residence referred to in Article 6(2) of the implementing Regulation shall be the institution of the child\u2019s or childrens\u2019 place of residence. 5. If the institution which has supplied benefits on a provisional basis has paid more than the amount for which it is ultimately responsible, it may claim reimbursement of the excess from the institution with primary responsibility in accordance with the procedure laid down in Article 73 of the implementing Regulation. Article 61 Procedure for applying Article 69 of the basic Regulation For the purposes of applying Article 69 of the basic Regulation, the Administrative Commission shall draw up a list of the additional or special family benefits for orphans covered by that Article. If there is no provision for the institution competent to grant, by priority right, such additional or special family benefits for orphans under the legislation it applies, it shall without delay forward any application for family benefits, together with all relevant documents and information, to the institution of the Member State to whose legislation the person concerned has been subject, for the longest period of time and which provides such additional or special family benefits for orphans. In some cases, this may mean referring back, under the same conditions, to the institution of the Member State under whose legislation the person concerned has completed the shortest of his or her insurance or residence periods. TITLE IV FINANCIAL PROVISIONS CHAPTER I Reimbursement of the cost of benefits in application of Article 35 and Article 41 of the basic Regulation Section 1 Reimbursement on the basis of actual expenditure Article 62 Principles 1. For the purposes of applying Article 35 and Article 41 of the basic Regulation, the actual amount of the expenses for benefits in kind, as shown in the accounts of the institution that provided them, shall be reimbursed to that institution by the competent institution, except where Article 63 of the implementing Regulation is applicable. 2. If any or part of the actual amount of the expenses for benefits referred to in paragraph 1 is not shown in the accounts of the institution that provided them, the amount to be refunded shall be determined on the basis of a lump-sum payment calculated from all the appropriate references obtained from the data available. The Administrative Commission shall assess the bases to be used for calculation of the lump-sum payment and shall decide the amount thereof. 3. Higher rates than those applicable to the benefits in kind provided to insured persons subject to the legislation applied by the institution providing the benefits referred to in paragraph 1 may not be taken into account in the reimbursement. Section 2 Reimbursement on the basis of fixed amounts Article 63 Identification of the Member States concerned 1. The Member States referred to in Article 35(2) of the basic Regulation, whose legal or administrative structures are such that the use of reimbursement on the basis of actual expenditure is not appropriate, are listed in Annex 3 to the implementing Regulation. 2. In the case of the Member States listed in Annex 3 to the implementing Regulation, the amount of benefits in kind supplied to: (a) family members who do not reside in the same Member State as the insured person, as provided for in Article 17 of the basic Regulation; and to (b) pensioners and members of their family, as provided for in Article 24(1) and Articles 25 and 26 of the basic Regulation; shall be reimbursed by the competent institutions to the institutions providing those benefits, on the basis of a fixed amount established for each calendar year. This fixed amount shall be as close as possible to actual expenditure. Article 64 Calculation method of the monthly fixed amounts and the total fixed amount 1. For each creditor Member State, the monthly fixed amount per person (Fi) for a calendar year shall be determined by dividing the annual average cost per person (Yi), broken down by age group (i), by 12 and by applying a reduction (X) to the result in accordance with the following formula: Fi = Yi*1/12*(1-X) Where: \u2014 the index (i = 1, 2 and 3) represents the three age groups used for calculating the fixed amounts: i = 1: persons aged under 20, i = 2: persons aged from 20 to 64, i = 3: persons aged 65 and over, \u2014 Yi represents the annual average cost per person in age group i, as defined in paragraph 2, \u2014 the coefficient X (0,20 or 0,15) represents the reduction as defined in paragraph 3, 2. The annual average cost per person (Yi) in age group i shall be obtained by dividing the annual expenditure on all benefits in kind provided by the institutions of the creditor Member State to all persons in the age group concerned subject to its legislation and residing within its territory by the average number of persons concerned in that age group in the calendar year in question. The calculation shall be based on the expenditure under the schemes referred to in Article 23 of the implementing Regulation. 3. The reduction to be applied to the monthly fixed amount shall, in principle, be equal to 20 % (X = 0,20). It shall be equal to 15 % (X = 0,15) for pensioners and members of their family where the competent Member State is not listed in Annex IV to the basic Regulation. 4. For each debtor Member State, the total fixed amount for a calendar year shall be the sum of the products obtained by multiplying, in each age group i, the determined monthly fixed amounts per person by the number of months completed by the persons concerned in the creditor Member State in that age group. The number of months completed by the persons concerned in the creditor Member State shall be the sum of the calendar months in a calendar year during which the persons concerned were, because of their residence in the territory of the creditor Member State, eligible to receive benefits in kind in that territory at the expense of the debtor Member State. Those months shall be determined from an inventory kept for that purpose by the institution of the place of residence, based on documentary evidence of the entitlement of the beneficiaries supplied by the competent institution. 5. No later than 1 May 2015, the Administrative Commission shall present a specific report on the application of this Article and in particular on the reductions referred to in paragraph 3. On the basis of that report, the Administrative Commission may present a proposal containing any amendments which may prove necessary in order to ensure that the calculation of fixed amounts comes as close as possible to the actual expenditure incurred and the reductions referred to in paragraph 3 do not result in unbalanced payments or double payments for the Member States. 6. The Administrative Commission shall establish the methods for determining the elements for calculating the fixed amounts referred to in paragraphs 1 to 5. 7. Notwithstanding paragraphs 1 to 4, Member States may continue to apply Articles 94 and 95 of Regulation (EEC) No 574/72 for the calculation of the fixed amount until 1 May 2015, provided that the reduction set out in paragraph 3 is applied. Article 65 Notification of annual average costs 1. The annual average cost per person in each age group for a specific year shall be notified to the Audit Board at the latest by the end of the second year following the year in question. If the notification is not made by this deadline, the annual average cost per person which the Administrative Commission has last determined for a previous year will be taken. 2. The annual average costs determined in accordance with paragraph 1 shall be published each year in the Official Journal of the European Union. Section 3 Common provisions Article 66 Procedure for reimbursement between institutions 1. The reimbursements between the Member States concerned shall be made as promptly as possible. Every institution concerned shall be obliged to reimburse claims before the deadlines mentioned in this Section, as soon as it is in a position to do so. A dispute concerning a particular claim shall not hinder the reimbursement of another claim or other claims. 2. The reimbursements between the institutions of the Member States, provided for in Articles 35 and 41 of the basic Regulation, shall be made via the liaison body. There may be a separate liaison body for reimbursements under Article 35 and Article 41 of the basic Regulation. Article 67 Deadlines for the introduction and settlement of claims 1. Claims based on actual expenditure shall be introduced to the liaison body of the debtor Member State within 12 months of the end of the calendar half-year during which those claims were recorded in the accounts of the creditor institution. 2. Claims of fixed amounts for a calendar year shall be introduced to the liaison body of the debtor Member State within the 12-month period following the month during which the average costs for the year concerned were published in the Official Journal of the European Union. The inventories referred to Article 64(4) of the implementing Regulation shall be presented by the end of the year following the reference year. 3. In the case referred to in Article 6(5) second subparagraph of the implementing Regulation, the deadline set out in paragraphs 1 and 2 of this Article shall not start before the competent institution has been identified. 4. Claims introduced after the deadlines specified in paragraphs 1 and 2 shall not be considered. 5. The claims shall be paid to the liaison body of the creditor Member State referred to in Article 66 of the implementing Regulation by the debtor institution within 18 months of the end of the month during which they were introduced to the liaison body of the debtor Member State. This does not apply to the claims which the debtor institution has rejected for a relevant reason within that period. 6. Any disputes concerning a claim shall be settled, at the latest, within 36 months following the month in which the claim was introduced. 7. The Audit Board shall facilitate the final closing of accounts in cases where a settlement cannot be reached within the period set out in paragraph 6, and, upon a reasoned request by one of the parties, shall give its opinion on a dispute within six months following the month in which the matter was referred to it. Article 68 Interest on late payments and down payments 1. From the end of the 18-month period set out in Article 67(5) of the implementing Regulation, interest can be charged by the creditor institution on outstanding claims, unless the debtor institution has made, within six months of the end of the month during which the claim was introduced, a down payment of at least 90 % of the total claim introduced pursuant to Article 67(1) or (2) of the implementing Regulation. For those parts of the claim not covered by the down payment, interest may be charged only from the end of the 36-month period set out in Article 67(6) of the implementing Regulation. 2. The interest shall be calculated on the basis of the reference rate applied by the European Central Bank to its main refinancing operations. The reference rate applicable shall be that in force on the first day of the month on which the payment is due. 3. No liaison body shall be obliged to accept a down payment as provided for in paragraph 1. If however, a liaison body declines such an offer, the creditor institution shall no longer be entitled to charge interest on late payments related to the claims in question other than under the second sentence of paragraph 1. Article 69 Statement of annual accounts 1. The Administrative Commission shall establish the claims situation for each calendar year in accordance with Article 72(g) of the basic Regulation, on the basis of the Audit Board\u2019s report. To this end, the liaison bodies shall notify the Audit Board, by the deadlines and according to the procedures laid down by the latter, of the amount of the claims introduced, settled or contested (creditor position) and the amount of claims received, settled or contested (debtor position). 2. The Administrative Commission may perform any appropriate checks on the statistical and accounting data used as the basis for drawing up the annual statement of claims provided for in paragraph 1 in order, in particular, to ensure that they comply with the rules laid down under this Title. CHAPTER II Reimbursement of unemployment benefits pursuant to Article 65 of the basic Regulation Article 70 Reimbursement of unemployment benefits If there is no agreement in accordance with Article 65(8) of the basic Regulation, the institution of the place of residence shall request reimbursement of unemployment benefits pursuant to Article 65(6) and (7) of the basic Regulation from the institution of the Member State to whose legislation the beneficiary was last subject. The request shall be made within six months of the end of the calendar half-year during which the last payment of unemployment benefit, for which reimbursement is requested, was made. The request shall indicate the amount of benefit paid during the three or five month-period referred to in Article 65(6) and (7) of the basic Regulation, the period for which the benefits were paid and the identification data of the unemployed person. The claims shall be introduced and paid via the liaison bodies of the Member States concerned. There is no requirement to consider requests introduced after the time-limit referred to in the first paragraph. Articles 66(1) and 67(5) to (7) of the implementing Regulation shall apply mutatis mutandis. From the end of the 18-month period referred to in Article 67(5) of the implementing Regulation, interest may be charged by the creditor institution on outstanding claims. The interest shall be calculated in accordance with Article 68(2) of the implementing Regulation. The maximum amount of the reimbursement referred to in the third sentence of Article 65(6) of the basic Regulation is in each individual case the amount of the benefit to which a person concerned would be entitled according to the legislation of the Member State to which he was last subject if registered with the employment services of that Member State. However, in relations between the Member States listed in Annex 5 to the implementing Regulation, the competent institutions of one of those Member States to whose legislation the person concerned was last subject shall determine the maximum amount in each individual case on the basis of the average amount of unemployment benefits provided under the legislation of that Member State in the preceding calendar year. CHAPTER III Recovery of benefits provided but not due, recovery of provisional payments and contributions, offsetting and assistance with recovery Section 1 Principles Article 71 Common provisions For the purposes of applying Article 84 of the basic Regulation and within the framework defined therein, the recovery of claims shall, wherever possible, be by way of offsetting either between the institutions of Member States concerned, or vis-\u00e0-vis the natural or legal person concerned in accordance with Articles 72 to 74 of the implementing Regulation. If it is not possible to recover all or any of the claim via this offsetting procedure, the remainder of the amount due shall be recovered in accordance with Articles 75 to 85 of the implementing Regulation. Section 2 Offsetting Article 72 Benefits received unduly 1. If the institution of a Member State has paid undue benefits to a person, that institution may, within the terms and limits laid down in the legislation it applies, request the institution of any other Member State responsible for paying benefits to the person concerned to deduct the undue amount from arrears or on-going payments owed to the person concerned regardless of the social security branch under which the benefit is paid. The institution of the latter Member State shall deduct the amount concerned subject to the conditions and limits applying to this kind of offsetting procedure in accordance with the legislation it applies in the same way as if it had made the overpayments itself, and shall transfer the amount deducted to the institution that has paid undue benefits. 2. By way of derogation from paragraph 1, if, when awarding or reviewing benefits in respect of invalidity benefits, old-age and survivors\u2019 pensions pursuant to Chapter 4 and 5 of Title III of the basic Regulation, the institution of a Member State has paid to a person benefits of undue sum, that institution may request the institution of any other Member State responsible for the payment of corresponding benefits to the person concerned to deduct the amount overpaid from the arrears payable to the person concerned. After the latter institution has informed the institution that has paid an undue sum of these arrears, the institution which has paid the undue sum shall within two months communicate the amount of the undue sum. If the institution which is due to pay arrears receives that communication within the deadline it shall transfer the amount deducted to the institution which has paid undue sums. If the deadline expires, that institution shall without delay pay out the arrears to the person concerned. 3. If a person has received social welfare assistance in one Member State during a period in which he was entitled to benefits under the legislation of another Member State, the body which provided the assistance may, if it is legally entitled to reclaim the benefits due to the person concerned, request the institution of any other Member State responsible for paying benefits in favour of the person concerned to deduct the amount of assistance paid from the amounts which that Member State pays to the person concerned. This provision shall apply mutatis mutandis to any family member of a person concerned who has received assistance in the territory of a Member State during a period in which the insured person was entitled to benefits under the legislation of another Member State in respect of that family member. The institution of a Member State which has paid an undue amount of assistance shall send a statement of the amount due to the institution of the other Member State, which shall then deduct the amount, subject to the conditions and limits laid down for this kind of offsetting procedure in accordance with the legislation it applies, and transfer the amount without delay to the institution that has paid the undue amount. Article 73 Provisionally paid benefits in cash or contributions 1. For the purposes of applying Article 6 of the implementing Regulation, at the latest three months after the applicable legislation has been determined or the institution responsible for paying the benefits has been identified, the institution which provisionally paid the cash benefits shall draw up a statement of the amount provisionally paid and shall send it to the institution identified as being competent. The institution identified as being competent for paying the benefits shall deduct the amount due in respect of the provisional payment from the arrears of the corresponding benefits it owes to the person concerned and shall without delay transfer the amount deducted to the institution which provisionally paid the cash benefits. If the amount of provisionally paid benefits exceeds the amount of arrears, or if arrears do not exist, the institution identified as being competent shall deduct this amount from ongoing payments subject to the conditions and limits applying to this kind of offsetting procedure under the legislation it applies, and without delay transfer the amount deducted to the institution which provisionally paid the cash benefits. 2. The institution which has provisionally received contributions from a legal and/or natural person shall not reimburse the amounts in question to the person who paid them until it has ascertained from the institution identified as being competent the sums due to it under Article 6(4) of the implementing Regulation. Upon request of the institution identified as being competent, which shall be made at the latest three months after the applicable legislation has been determined, the institution that has provisionally received contributions shall transfer them to the institution identified as being competent for that period for the purpose of settling the situation concerning the contributions owed by the legal and/or natural person to it. The contributions transferred shall be retroactively deemed as having been paid to the institution identified as being competent. If the amount of provisionally paid contributions exceeds the amount the legal and/or natural person owes to the institution identified as being competent, the institution which provisionally received contributions shall reimburse the amount in excess to the legal and/or natural person concerned. Article 74 Costs related to offsetting No costs are payable where the debt is recovered via the offsetting procedure provided for in Articles 72 and 73 of the implementing Regulation. Section 3 Recovery Article 75 Definitions and common provisions 1. For the purposes of this Section: \u2014 \u2018claim\u2019 means all claims relating to contributions or to benefits paid or provided unduly, including interest, fines, administrative penalties and all other charges and costs connected with the claim in accordance with the legislation of the Member State making the claim; \u2014 \u2018applicant party\u2019 means, in respect of each Member State, any institution which makes a request for information, notification or recovery concerning a claim as defined above, \u2014 \u2018requested party\u2019 means, in respect of each Member State, any institution to which a request for information, notification or recovery can be made, 2. Requests and any related communications between the Member States shall, in general, be addressed via designated institutions. 3. Practical implementation measures, including, among others, those related to Article 4 of the implementing Regulation and to setting a minimum threshold for the amounts for which a request for recovery can be made, shall be taken by the Administrative Commission. Article 76 Requests for information 1. At the request of the applicant party, the requested party shall provide any information which would be useful to the applicant party in the recovery of its claim. In order to obtain that information, the requested party shall make use of the powers provided for under the laws, regulations or administrative provisions applying to the recovery of similar claims arising in its own Member State. 2. The request for information shall indicate the name, last known address, and any other relevant information relating to the identification of the legal or natural person concerned to whom the information to be provided relates and the nature and amount of the claim in respect of which the request is made. 3. The requested party shall not be obliged to supply information: (a) which it would not be able to obtain for the purpose of recovering similar claims arising in its own Member State; (b) which would disclose any commercial, industrial or professional secrets; or (c) the disclosure of which would be liable to prejudice the security of or be contrary to the public policy of the Member State. 4. The requested party shall inform the applicant party of the grounds for refusing a request for information. Article 77 Notification 1. The requested party shall, at the request of the applicant party, and in accordance with the rules in force for the notification of similar instruments or decisions in its own Member State, notify the addressee of all instruments and decisions, including those of a judicial nature, which come from the Member State of the applicant party and which relate to a claim and/or to its recovery. 2. The request for notification shall indicate the name, address and any other relevant information relating to the identification of the addressee concerned to which the applicant party normally has access, the nature and the subject of the instrument or decision to be notified and, if necessary the name, address and any other relevant information relating to the identification of the debtor and the claim to which the instrument or decision relates, and any other useful information. 3. The requested party shall without delay inform the applicant party of the action taken on its request for notification and, particularly, of the date on which the decision or instrument was forwarded to the addressee. Article 78 Request for recovery 1. The request for recovery of a claim, addressed by the applicant party to the requested party, shall be accompanied by an official or certified copy of the instrument permitting its enforcement, issued in the Member State of the applicant party and, if appropriate, by the original or a certified copy of other documents necessary for recovery. 2. The applicant party may only make a request for recovery if: (a) the claim and/or the instrument permitting its enforcement are not contested in its own Member State, except in cases where the second subparagraph of Article 81(2) of the implementing Regulation is applied; (b) it has, in its own Member State, applied appropriate recovery procedures available to it on the basis of the instrument referred to in paragraph 1, and the measures taken will not result in the payment in full of the claim; (c) the period of limitation according to its own legislation has not expired. 3. The request for recovery shall indicate: (a) the name, address and any other relevant information relating to the identification of the natural or legal person concerned and/or to the third party holding his or her assets; (b) the name, address and any other relevant information relating to the identification of the applicant party; (c) a reference to the instrument permitting its enforcement, issued in the Member State of the applicant party; (d) the nature and amount of the claim, including the principal, the interest, fines, administrative penalties and all other charges and costs due indicated in the currencies of the Member States of the applicant and requested parties; (e) the date of notification of the instrument to the addressee by the applicant party and/or by the requested party; (f) the date from which and the period during which enforcement is possible under the laws in force in the Member State of the applicant party; (g) any other relevant information. 4. The request for recovery shall also contain a declaration by the applicant party confirming that the conditions laid down in paragraph 2 have been fulfilled. 5. The applicant party shall forward to the requesting party any relevant information relating to the matter which gave rise to the request for recovery, as soon as this comes to its knowledge. Article 79 Instrument permitting enforcement of the recovery 1. In accordance with Article 84(2) of the basic Regulation, the instrument permitting enforcement of the claim shall be directly recognised and treated automatically as an instrument permitting the enforcement of a claim of the Member State of the requested party. 2. Notwithstanding paragraph 1, the instrument permitting enforcement of the claim may, where appropriate and in accordance with the provisions in force in the Member State of the requested party, be accepted as, recognised as, supplemented with, or replaced by an instrument authorising enforcement in the territory of that Member State. Within three months of the date of receipt of the request for recovery, Member States shall endeavour to complete the acceptance, recognition, supplementing or replacement, except in cases where the third subparagraph of this paragraph applies. Member States may not refuse to complete these actions where the instrument permitting enforcement is properly drawn up. The requested party shall inform the applicant party of the grounds for exceeding the three-month period. If any of these actions should give rise to a dispute in connection with the claim and/or the instrument permitting enforcement issued by the applicant party, Article 81 of the implementing Regulation shall apply. Article 80 Payment arrangements and deadlines 1. Claims shall be recovered in the currency of the Member State of the requested party. The entire amount of the claim that is recovered by the requested party shall be remitted by the requested party to the applicant party. 2. The requested party may, where the laws, regulations or administrative provisions in force in its own Member State so permit, and after consulting the applicant party, allow the debtor time to pay or authorise payment by instalment. Any interest charged by the requested party in respect of such extra time to pay shall also be remitted to the applicant party. From the date on which the instrument permitting enforcement of the recovery of the claim has been directly recognised in accordance with Article 79(1) of the implementing Regulation, or accepted, recognised, supplemented or replaced in accordance with Article 79(2) of the implementing Regulation, interest shall be charged for late payment under the laws, regulations and administrative provisions in force in the Member State of the requested party and shall also be remitted to the applicant party. Article 81 Contestation concerning the claim or the instrument permitting enforcement of its recovery and contestation concerning enforcement measures 1. If, in the course of the recovery procedure, the claim and/or the instrument permitting its enforcement issued in the Member State of the applicant party are contested by an interested party, the action shall be brought by this party before the appropriate authorities of the Member State of the applicant party, in accordance with the laws in force in that Member State. The applicant party shall without delay notify the requested party of this action. The interested party may also inform the requested party of the action. 2. As soon as the requested party has received the notification or information referred to in paragraph 1 either from the applicant party or from the interested party, it shall suspend the enforcement procedure pending the decision of the appropriate authority in the matter, unless the applicant party requests otherwise in accordance with the second subparagraph of this paragraph. Should the requested party deem it necessary, and without prejudice to Article 84 of the implementing Regulation, it may take precautionary measures to guarantee recovery insofar as the laws or regulations in force in its own Member State allow such action for similar claims. Notwithstanding the first subparagraph, the applicant party may, in accordance with the laws, regulations and administrative practices in force in its own Member State, request the requested party to recover a contested claim, in so far as the relevant laws, regulations and administrative practices in force in the requested party\u2019s Member State allow such action. If the result of the contestation is subsequently favourable to the debtor, the applicant party shall be liable for the reimbursement of any sums recovered, together with any compensation due, in accordance with the legislation in force in the requested party\u2019s Member State. 3. Where the contestation concerns enforcement measures taken in the Member State of the requested party, the action shall be brought before the appropriate authority of that Member State in accordance with its laws and regulations. 4. Where the appropriate authority before which the action is brought in accordance with paragraph 1 is a judicial or administrative tribunal, the decision of that tribunal, insofar as it is favourable to the applicant party and permits recovery of the claim in the Member State of the applicant party, shall constitute the \u2018instrument permitting enforcement\u2019 within the meaning of Articles 78 and 79 of the implementing Regulation and the recovery of the claim shall proceed on the basis of that decision. Article 82 Limits applying to assistance 1. The requested party shall not be obliged: (a) to grant the assistance provided for in Articles 78 to 81 of the implementing Regulation if recovery of the claim would, because of the situation of the debtor, create serious economic or social difficulties in the Member State of the requested party, insofar as the laws, regulations or administrative practices in force in the Member State of the requested party allow such action for similar national claims; (b) to grant the assistance provided for in Articles 76 to 81 of the implementing Regulation, if the initial request under Articles 76 to 78 of the implementing Regulation applies to claims more than five years old, dating from the moment the instrument permitting the recovery was established in accordance with the laws, regulations or administrative practices in force in the Member State of the applicant party at the date of the request. However, if the claim or instrument is contested, the time limit begins from the moment that the Member State of the applicant party establishes that the claim or the enforcement order permitting recovery may no longer be contested. 2. The requested party shall inform the applicant party of the grounds for refusing a request for assistance. Article 83 Periods of limitation 1. Questions concerning periods of limitation shall be governed as follows: (a) by the laws in force in the Member State of the applicant party, insofar as they concern the claim and/or the instrument permitting its enforcement; and (b) by the laws in force in the Member State of the requested party, insofar as they concern enforcement measures in the requested Member State. Periods of limitation according to the laws in force in the Member State of the requested party shall start from the date of direct recognition or from the date of acceptance, recognition, supplementing or replacement in accordance with Article 79 of the implementing Regulation. 2. Steps taken in the recovery of claims by the requested party in pursuance of a request for assistance, which, if they had been carried out by the applicant party, would have had the effect of suspending or interrupting the period of limitation according to the laws in force in the Member State of the applicant party, shall be deemed to have been taken in the latter State, in so far as that effect is concerned. Article 84 Precautionary measures Upon reasoned request by the applicant party, the requested party shall take precautionary measures to ensure recovery of a claim in so far as the laws and regulations in force in the Member State of the requested party so permit. For the purposes of implementing the first paragraph, the provisions and procedures laid down in Articles 78, 79, 81 and 82 of the implementing Regulation shall apply mutatis mutandis. Article 85 Costs related to recovery 1. The requested party shall recover from the natural or legal person concerned and retain any costs linked to recovery which it incurs, in accordance with the laws and regulations of the Member State of the requested party that apply to similar claims. 2. Mutual assistance afforded under this Section shall, as a rule, be free of charge. However, where recovery poses a specific problem or concerns a very large amount in costs, the applicant and the requested parties may agree on reimbursement arrangements specific to the cases in question. 3. The Member State of the applicant party shall remain liable to the Member State of the requested party for any costs and any losses incurred as a result of actions held to be unfounded, as far as either the substance of the claim or the validity of the instrument issued by the applicant party is concerned. Article 86 Review clause 1. No later than the fourth full calendar year after the entry into force of the implementing Regulation, the Administrative Commission shall present a comparative report on the time limits set out in Article 67(2), (5) and (6) of the implementing Regulation. On the basis of this report, the European Commission may, as appropriate, submit proposals to review these time limits with the aim of reducing them in a significant way. 2. No later than the date referred to in paragraph 1, the Administrative Commission shall also assess the rules for conversion of periods set out in Article 13 with a view to simplifying those rules, if possible. 3. No later than 1 May 2015, the Administrative Commission shall present a report specifically assessing the application of Chapters I and III of Title IV of the implementing Regulation, in particular with regard to the procedures and time limits referred to in Article 67(2), (5) and (6) of the implementing Regulation and to the recovery procedures referred to in Articles 75 to 85 of the implementing Regulation. In the light of this report, the European Commission may, if necessary, submit appropriate proposals to make these procedures more efficient and balanced. TITLE V MISCELLANEOUS, TRANSITIONAL AND FINAL PROVISIONS Article 87 Medical examination and administrative checks 1. Without prejudice to other provisions, where a recipient or a claimant of benefits, or a member of his family, is staying or residing within the territory of a Member State other than that in which the debtor institution is located, the medical examination shall be carried out, at the request of that institution, by the institution of the beneficiary\u2019s place of stay or residence in accordance with the procedures laid down by the legislation applied by that institution. The debtor institution shall inform the institution of the place of stay or residence of any special requirements, if necessary, to be followed and points to be covered by the medical examination. 2. The institution of the place of stay or residence shall forward a report to the debtor institution that requested the medical examination. This institution shall be bound by the findings of the institution of the place of stay or residence. The debtor institution shall reserve the right to have the beneficiary examined by a doctor of its choice. However, the beneficiary may be asked to return to the Member State of the debtor institution only if he or she is able to make the journey without prejudice to his health and the cost of travel and accommodation is paid for by the debtor institution. 3. Where a recipient or a claimant of benefits, or a member of his family, is staying or residing in the territory of a Member State other than that in which the debtor institution is located, the administrative check shall, at the request of the debtor institution, be performed by the institution of the beneficiary\u2019s place of stay or residence. Paragraph 2 shall also apply in this case. 4. Paragraphs 2 and 3 shall also apply in determining or checking the state of dependence of a recipient or a claimant of the long-term care benefits mentioned in Article 34 of the basic Regulation. 5. The competent authorities or competent institutions of two or more Member States may agree specific provisions and procedures to improve fully or partly the labour-market readiness of claimants and recipients and their participation in any schemes or programmes available in the Member State of stay or residence for that purpose. 6. As an exception to the principle of free-of-charge mutual administrative cooperation in Article 76(2) of the basic Regulation, the effective amount of the expenses of the checks referred to in paragraphs 1 to 5 shall be refunded to the institution which was requested to carry them out by the debtor institution which requested them. Article 88 Notifications 1. The Member States shall notify the European Commission of the details of the bodies defined in Article 1(m), (q) and (r) of the basic Regulation and Article 1(2)(a) and (b) of the implementing Regulation, and of the institutions designated in accordance with the implementing Regulation. 2. The bodies specified in paragraph 1 shall be provided with an electronic identity in the form of an identification code and electronic address. 3. The Administrative Commission shall establish the structure, content and detailed arrangements, including the common format and model, for notification of the details specified in paragraph 1. 4. Annex 4 to the implementing Regulation gives details of the public database containing the information specified in paragraph 1. The database shall be established and managed by the European Commission. The Member States shall, however, be responsible for the input of their own national contact information into this database. Moreover, the Member States shall ensure the accuracy of the input of the national contact information required under paragraph 1. 5. The Member States shall be responsible for keeping the information specified in paragraph 1 up to date. Article 89 Information 1. The Administrative Commission shall prepare the information needed to ensure that the parties concerned are aware of their rights and the administrative formalities required in order to assert them. This information shall, where possible, be disseminated electronically via publication online on sites accessible to the public. The Administrative Commission shall ensure that the information is regularly updated and monitor the quality of services provided to customers. 2. The Advisory Committee referred to in Article 75 of the basic Regulation may issue opinions and recommendations on improving the information and its dissemination. 3. The competent authorities shall ensure that their institutions are aware of and apply all the Community provisions, legislative or otherwise, including the decisions of the Administrative Commission, in the areas covered by and within the terms of the basic Regulation and the implementing Regulation. Article 90 Currency conversion For the purposes of applying the basic Regulation and the implementing Regulation, the exchange rate between two currencies shall be the reference rate published by the European Central Bank. The date to be taken into account for determining the exchange rate shall be fixed by the Administrative Commission. Article 91 Statistics The competent authorities shall compile statistics on the application of the basic Regulation and the implementing Regulation and forward them to the secretariat of the Administrative Commission. Those data shall be collected and organised according to the plan and method defined by the Administrative Commission. The European Commission shall be responsible for disseminating the information. Article 92 Amendment of the Annexes Annexes 1, 2, 3, 4 and 5 to the implementing Regulation and Annexes VI, VII, VIII and IX to the basic Regulation may be amended by Commission Regulation at the request of the Administrative Commission. Article 93 Transitional provisions Article 87 of the basic Regulation shall apply to the situations covered by the implementing Regulation. Article 94 Transitional provisions relating to pensions 1. Where the contingency arises before the date of entry into force of the implementing Regulation in the territory of the Member State concerned and the claim for pension has not been awarded before that date, such claim shall give rise to a double award, in as much as benefits must be granted, pursuant to such contingency, for a period prior to that date: (a) for the period prior to the date of entry into force of the implementing Regulation in the territory of the Member State concerned, in accordance with Regulation (EEC) No 1408/71, or with agreements in force between the Member States concerned; (b) for the period commencing on the date of entry into force of the implementing Regulation in the territory of the Member State concerned, in accordance with the basic Regulation. However, if the amount calculated pursuant to the provisions referred to under point (a) is greater than that calculated pursuant to the provisions referred to under point (b), the person concerned shall continue to be entitled to the amount calculated pursuant to the provisions referred to under point (a). 2. A claim for invalidity, old age or survivors\u2019 benefits submitted to an institution of a Member State from the date of entry into force of the implementing Regulation in the territory of the Member State concerned shall automatically necessitate the reassessment of the benefits which have been awarded for the same contingency prior to that date by the institution or institutions of one or more Member States, in accordance with the basic Regulation; such reassessment may not give rise to any reduction in the amount of the benefit awarded. Article 95 Transitional period for electronic data exchanges 1. Each Member State may benefit from a transitional period for exchanging data by electronic means as provided for by Article 4(2) of the implementing Regulation. These transitional periods shall not exceed 24 months from the date of entry into force of the implementing Regulation. However, if the delivery of the necessary Community infrastructure (Electronic Exchange of Social Security information \u2014 EESSI) is significantly delayed with regard to the entry into force of the implementing Regulation, the Administrative Commission may agree on any appropriate extension of these periods. 2. The practical arrangements for any necessary transitional periods referred to in paragraph 1 shall be laid down by the Administrative Commission with a view to ensuring the necessary data exchange for the application of the basic Regulation and the implementing Regulation. Article 96 Repeal 1. Regulation (EEC) No 574/72 is repealed with effect from 1 May 2010. However, Regulation (EEC) No 574/72 shall remain in force and continue to have legal effect for the purposes of: (a) Council Regulation (EC) No 859/2003 of 14 May 2003 extending the provisions of Regulation (EEC) No 1408/71 and Regulation (EEC) No 574/72 to nationals of third countries who are not already covered by those provisions solely on the grounds of their nationality (6), until such time as that Regulation is repealed or amended; (b) Council Regulation (EEC) No 1661/85 of 13 June 1985 laying down the technical adaptations to the Community rules on social security for migrant workers with regard to Greenland (7), until such time as that Regulation is repealed or amended; (c) the Agreement on the European Economic Area (8), the Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other, on the free movement of persons (9) and other agreements containing a reference to Regulation (EEC) No 574/72, until such time as those agreements are amended on the basis of the implementing Regulation. 2. In Council Directive 98/49/EC of 29 June 1998 on safeguarding the supplementary pension rights of employed and self-employed persons moving within the Community (10), and more generally in all other Community acts, the references to Regulation (EEC) No 574/72 shall be understood as referring to the implementing Regulation. Article 97 Publication and entry into force This Regulation shall be published in the Official Journal of the European Union. It shall enter into force on 1 May 2010. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 September 2009. For the European Parliament The President J. BUZEK For the Council The President C. MALMSTR\u00d6M (1) OJ L 166, 30.4.2004, p. 1. (2) OJ C 324, 30.12.2006, p. 59. (3) Opinion of the European Parliament of 9 July 2008 (not yet published in the Official Journal), Council Common Position of 17 December 2008 (OJ C 38 E, 17.2.2009, p. 26) and Position of the European Parliament of 22 April 2009. Council Decision of 27 July 2009. (4) OJ L 150, 10.6.2008, p. 28. (5) OJ L 74, 27.3.1972, p. 1. (6) OJ L 124, 20.5.2003, p. 1. (7) OJ L 160, 20.6.1985, p. 7. (8) OJ L 1, 3.1.1994, p. 1. (9) OJ L 114, 30.4.2002, p. 6. (10) OJ L 209, 25.7.1998, p. 46. ANNEX 1 Implementing provisions for bilateral agreements remaining in force and new bilateral implementing agreements (referred to in Article 8(1) and Article 9(2) of the implementing Regulation) BELGIUM \u2014 DENMARK The Exchange of Letters of 8 May 2006 and 21 June 2006 on the Agreement of reimbursement with the actual amount of the benefit provided to members of the family of an employed or self-employed person insured in Belgium, where the family member resides in Denmark and to pensioners and/or members of their family insured in Belgium but residing in Denmark BELGIUM \u2014 GERMANY The Agreement of 29 January 1969 on the collection and recovery of social security contributions BELGIUM \u2014 IRELAND The Exchange of Letters of 19 May and 28 July 1981 concerning Articles 36(3) and 70(3) of Regulation (EEC) No 1408/71 (reciprocal waiving of reimbursement of the costs of benefits in kind and of unemployment benefits under Chapters 1 and 6 of Title III of Regulation (EEC) No 1408/71) and Article 105(2) of Regulation (EEC) No 574/72 (reciprocal waiving of reimbursement of the costs of administrative checks and medical examinations). BELGIUM \u2014 SPAIN The Agreement of 25 May 1999 on the reimbursement of benefits in kind according to the provisions of Regulations (EEC) No 1408/71 and No 574/72 BELGIUM \u2014 FRANCE (a) The Agreement of 4 July 1984 relating to medical examinations of frontier workers resident in one country and working in another (b) The Agreement of 14 May 1976 on the waiving of reimbursement of the costs of administrative checks and medical examinations, adopted pursuant to Article 105(2) of Regulation (EEC) No 574/72 (c) The Agreement of 3 October 1977 implementing Article 92 of Regulation (EEC) No 1408/71 (recovery of social security contributions) (d) The Agreement of 29 June 1979 concerning the reciprocal waiving of reimbursement provided for in Article 70(3) of Regulation (EEC) No 1408/71 (costs of unemployment benefit) (e) The Administrative Arrangement of 6 March 1979 on the procedures for the implementation of the Additional Convention of 12 October 1978 on social security between Belgium and France in respect of its provisions relating to self-employed persons (f) The Exchange of Letters of 21 November 1994 and 8 February 1995 concerning the procedures for the settlement of reciprocal claims pursuant to Articles 93, 94, 95 and 96 of Regulation (EEC) No 574/72 BELGIUM \u2014 ITALY (a) The Agreement of 12 January 1974 implementing Article 105(2) of Regulation (EEC) No 574/72 (b) The Agreement of 31 October 1979 implementing Article 18(9) of Regulation (EEC) No 574/72 (c) The Exchange of Letters of 10 December 1991 and 10 February 1992 concerning the reimbursement of reciprocal claims under Article 93 of Regulation (EEC) No 574/72 (d) The Agreement of 21.11.2003 on the terms for settling reciprocal claims under Articles 94 and 95 of Council Regulation (EEC) No 574/72 BELGIUM \u2014 LUXEMBOURG (a) The Agreement of 28 January 1961 on the recovery of social security contributions (b) The Agreement of 16 April 1976 on the waiving of reimbursement of the costs of administrative checks and medical examinations, as provided for in Article 105(2) of Regulation (EEC) No 574/72 BELGIUM \u2014 NETHERLANDS (a) The Agreement of 21 March 1968 on the collection and recovery of social security contributions, together with the Administrative Arrangement of 25 November 1970 implementing that Agreement (b) The Agreement of 13 March 2006 on health care insurance (c) The Agreement of 12 August 1982 on sickness, maternity and invalidity insurance BELGIUM \u2014 UNITED KINGDOM (a) The Exchange of Letters of 4 May and 14 June 1976 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) (b) The Exchange of Letters of 18 January and 14 March 1977 regarding Article 36(3) of Regulation (EEC) No 1408/71 (arrangement for reimbursement or waiving of reimbursement of the costs of benefits in kind provided under the terms of Chapter 1 of Title III of Regulation (EEC) No 1408/71) as amended by the Exchange of Letters of 4 May and 23 July 1982 (agreement for reimbursement of costs incurred under Article 22(1)(a) of Regulation (EEC) No 1408/71) BULGARIA \u2014 CZECH REPUBLIC Article 29(1) and (3) of the Agreement of 25 November 1998 and Article 5(4) of the Administrative Arrangement of 30 November 1999 on the waiving of reimbursement of the costs of administrative checks and medical examinations BULGARIA \u2014 GERMANY Articles 8 to 9 of the Administrative Agreement on implementing the Convention on social security of 17 December 1997 in the pension field CZECH REPUBLIC \u2014 SLOVAKIA Articles 15 and 16 of the Administrative Arrangement of 8 January 1993 concerning the specification of a seat of the employer and the place of residence for the purposes of application of Article 20 of the Convention of 29 October 1992 on social security DENMARK \u2014 IRELAND The Exchange of Letters of 22 December 1980 and 11 February 1981 on the reciprocal waiving of reimbursement of the costs of benefits in kind granted under insurance for sickness, maternity, accidents at work and occupational diseases, and of unemployment benefits and of the costs of administrative checks and medical examinations (Articles 36(3), 63(3) of Regulation (EEC) No 1408/71 and Article 105(2) of Regulation (EEC) No 574/72) DENMARK \u2014 GREECE Agreement of 8 May 1986 on the partial reciprocal waiving of reimbursement in respect of benefits in kind for sickness, maternity, accidents at work and occupational diseases and waiving of reimbursement in respect of administrative checks and medical examinations DENMARK \u2014 SPAIN Agreement of 11 December 2006 of advance payment, time-limits and reimbursement with the actual amount of the benefit provided to members of the family of an employed or self-employed person insured in Spain, where the family member resides in Denmark and to pensioners and/or members of their family insured in Spain but residing in Denmark DENMARK \u2014 FRANCE The Arrangement of 29 June 1979 and the additional Arrangement of 2 June 1993 concerning the partial waiving of reimbursement pursuant to Article 36(3) and Article 63(3) of Regulation (EEC) No 1408/71 and the reciprocal waiving of reimbursement pursuant to Article 105(2) of Regulation (EEC) No 574/72 (partial waiving of reimbursement of the cost of benefits in kind in respect of sickness, maternity, accidents at work and occupational diseases, and waiving of reimbursement of the cost of administrative checks and medical examinations) DENMARK \u2014 ITALY The Agreement of 18 November 1998 on the reimbursement of costs of benefits in kind under insurance for sickness, maternity, accidents at work and occupational diseases, costs of administrative checks and medical examinations DENMARK \u2014 LUXEMBOURG The Agreement of 19 June 1978 concerning the reciprocal waiving of reimbursement provided for in Article 36(3), 63(3) and 70(3) of Regulation (EEC) No 1408/71 and Article 105(2) of Regulation (EEC) No 574/72 costs of benefits in kind for sickness, maternity, accidents at work and occupational diseases, costs of unemployment benefit and costs of administrative checks and medical examinations) DENMARK \u2014 NETHERLANDS The Exchange of Letters of 30 March and 25 April 1979 as amended by agreement of 12 December 2006 on reimbursement of costs of benefits in kind for sickness, maternity, accidents at work and occupational diseases DENMARK \u2014 PORTUGAL The Agreement of 17 April 1998 on the partial waiving of reimbursement of costs of benefits in kind under insurance for sickness, maternity, accidents at work and occupational diseases and administrative checks and medical examinations DENMARK \u2014 FINLAND Article 15 of the Nordic Convention on Social Security of 18 August 2003: Agreement on the reciprocal waiver of refund pursuant to Articles 36, 63 and 70 of Regulation (EEC) No 1408/71 (cost of benefits in kind in respect of sickness and maternity, accidents at work and occupational diseases, and unemployment benefits) and Article 105 of Regulation (EEC) No 574/72 (costs of administrative checks and medical examinations) DENMARK \u2014 SWEDEN Article 15 of the Nordic Convention on Social Security of 18 August 2003: Agreement on the reciprocal waiver of refund pursuant to Articles 36, 63 and 70 of Regulation (EEC) No 1408/71 (cost of benefits in kind in respect of sickness and maternity, accidents at work and occupational diseases, and unemployment benefits) and Article 105 of Regulation (EEC) No 574/72 (costs of administrative checks and medical examinations) DENMARK \u2014 UNITED KINGDOM The Exchange of Letters of 30 March and 19 April 1977 as modified by an Exchange of Letters of 8 November 1989 and of 10 January 1990 on agreement of waiving of reimbursement of the costs of benefits in kind and administrative checks and medical examinations GERMANY \u2014 FRANCE The Agreement of 26 May 1981 implementing Article 92 of Regulation (EEC) No 1408/71 (collection and recovery of social security contributions) GERMANY \u2014 ITALY The Agreement of 3 April 2000 on the collection and recovery of social security contributions GERMANY \u2014 LUXEMBOURG (a) The Agreement of 14 October 1975 on the waiving of reimbursement of the costs of administrative checks and medical examinations, adopted pursuant to Article 105(2) of Regulation (EEC) No 574/72 (b) The Agreement of 14 October 1975 on the collection and recovery of social security contributions (c) The Agreement of 25 January 1990 relating to the application of Articles 20 and 22(1)(b) and (c) of Regulation (EEC) No 1408/71 GERMANY \u2014 NETHERLANDS (a) Article 9 of Administrative Arrangements of 18 April 2001 on the Convention of 18 April 2001 (payment of pensions) (b) The Agreement of 21 January 1969 on the recovery of social insurance contributions GERMANY \u2014 AUSTRIA Section II, Number 1, and section III of the Agreement of 2 August 1979 on the implementation of the Convention on unemployment insurance of 19 July 1978 shall continue to apply to persons who have exercised an activity as a frontier worker on or before 1 January 2005 who become unemployed before 1 January 2011 GERMANY \u2014 POLAND The Agreement of 11 January 1977 on the implementation of the Convention of 9 October 1975 on old-age pensions and benefits for accidents at work ESTONIA \u2014 UNITED KINGDOM The Arrangement finalised on 29 March 2006 between the Competent Authorities of the Republic of Estonia and of the United Kingdom under Articles 36(3) and 63(3) of Regulation (EEC) No 1408/71 establishing other methods of reimbursement of the costs of benefits in kind provided under this Regulation by both countries with effect from 1 May 2004 IRELAND \u2014 FRANCE The Exchange of Letters of 30 July 1980 and 26 September 1980 concerning Articles 36(3) and 63(3) of Regulation (EEC) No 1408/71 (reciprocal waiving of reimbursement of the costs of benefits in kind) and Article 105(2) of Regulation (EEC) No 574/72 (reciprocal waiving of reimbursement of the costs of administrative checks and medical examinations) IRELAND \u2014 LUXEMBOURG The Exchange of Letters of 26 September 1975 and 5 August 1976 concerning Articles 36(3) and 63(3) of Regulation (EEC) No 1408/71and Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of benefits in kind provided pursuant to Chapter 1 or 4 of Title III of Regulation (EEC) No 1408/71, and of the costs of administrative checks and medical examinations referred to in Article 105 of Regulation (EEC) No 574/72) IRELAND \u2014 NETHERLANDS The Exchange of Letters of 22 April and 27 July 1987 concerning Article 70(3) of Regulation (EEC) No 1408/71 (waiving of costs of reimbursement in respect of benefits awarded in application of Article 69 of Regulation (EEC) No 1408/71) and Article 105(2) of Regulation (EEC) No 574/72 (waiving of the reimbursement of the costs of administrative checks and medical examinations referred to in Article 105 of Regulation (EEC) No 574/72) IRELAND \u2014 SWEDEN The Agreement of 8 November 2000 on the waiving of reimbursement of the costs of benefits in kind of sickness, maternity, accidents at work and occupational diseases, and the costs of administrative and medical controls IRELAND \u2014 UNITED KINGDOM The Exchange of Letters of 9 July 1975 regarding Articles 36(3) and 63(3) of Regulation (EEC) No 1408/71 (arrangement for reimbursement or waiving of reimbursement of the costs of benefits in kind provided under the terms of Chapter 1 or 4 of Title III of Regulation (EEC) No 1408/71) and Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) GREECE \u2014 NETHERLANDS The Exchange of Letters of 8 September 1992 and 30 June 1993 concerning the methods of reimbursement between institutions SPAIN \u2014 FRANCE The Agreement of 17 May 2005 establishing the specific arrangements for the management and settlement of reciprocal claims in respect of health care benefits pursuant to Regulations (EEC) No 1408/71 and (EEC) No 574/72 SPAIN \u2014 ITALY The Agreement on a new procedure for the improvement and simplification of reimbursements of costs for health care of 21 November 1997 concerning Article 36(3) of Regulation (EEC) No 1408/71 (reimbursement of sickness and maternity benefits in kind) and Articles 93, 94, 95, 100 and 102(5) of Regulation (EEC) No 574/72 (procedures for the refund and sickness and maternity insurance benefits and late claims) SPAIN \u2014 NETHERLANDS The Agreement of 21 February 2000 between the Netherlands and Spain facilitating the settlement of reciprocal claims relating to sickness and maternity insurance benefits when implementing the provisions of Regulations (EEC) No 1408/71 and (EEC) No 574/72 SPAIN \u2014 PORTUGAL (a) Articles 42, 43 and 44 of the Administrative Arrangement of 22 May 1970 (export of unemployment benefits). This entry will remain valid for two years from the date of application of Regulation (EC) No 883/2004 (b) The Agreement of 2 October 2002 laying down detailed arrangements for the management and settlement of reciprocal claims for health care with a view to facilitating and accelerating the settlement of these claims SPAIN \u2014 SWEDEN The Agreement of 1 December 2004 on the reimbursement of the costs of benefits in kind provided under Regulations (EEC) No 1408/71 and (EEC) No 574/72 SPAIN \u2014 UNITED KINGDOM The Agreement of 18 June 1999 on the reimbursement of costs for benefits in kind granted pursuant to the provisions of Regulations (EEC) No 1408/71 and (EEC) No 574/72 FRANCE \u2014 ITALY (a) The Exchange of Letters of 14 May and 2 August 1991 concerning the terms for settling reciprocal claims under Article 93 of Regulation (EEC) No 574/72 (b) The supplementary Exchange of Letters of 22 March and 15 April 1994 concerning the procedures for the settlement of reciprocal debts under the terms of Articles 93, 94, 95 and 96 of Regulation (EEC) No 574/72 (c) The Exchange of Letters of 2 April 1997 and 20 October 1998 modifying the Exchange of Letters mentioned under points (a) and (b) concerning the procedures for the settlement of reciprocal debts under the terms of Articles 93, 94, 95 and 96 of Regulation (EEC) No 574/72 (d) The Agreement of 28 June 2000 waiving reimbursement of the costs referred to in Article 105(1) of Regulation (EEC) No 574/72 for administrative checks and medical examinations requested under Article 51 of the abovementioned Regulation FRANCE \u2014 LUXEMBOURG (a) The Agreement of 2 July 1976 on the waiving of reimbursement, provided for in Article 36(3) of Council Regulation (EEC) No 1408/71 of 14 June 1971, of the costs of sickness or maternity insurance benefits in kind provided to members of a worker\u2019s family who do not reside in the same country as the worker (b) The Agreement of 2 July 1976 on the waiving of reimbursement, provided for in Article 36(3) of Council Regulation (EEC) No 1408/71 of 14 June 1971, of the costs of sickness or maternity insurance benefits in kind provided to former frontier workers, the members of their families or their survivors (c) The Agreement of 2 July 1976 on the waiving of reimbursement of the costs of administrative checks and medical examinations provided for in Article 105(2) of Council Regulation (EEC) No 574/72 of 21 March 1972 (d) The Exchange of Letters of 17 July and 20 September 1995 concerning the terms for settling reciprocal claims under Articles 93, 95 and 96 of Regulation (EEC) No 574/72 FRANCE \u2014 NETHERLANDS (a) The Agreement of 28 April 1997 on the waiving of reimbursement of the costs of administrative checks and medical examinations pursuant to Article 105 of Regulation (EEC) No 574/72 (b) The Agreement of 29 September 1998 laying down the special conditions for determining the amounts to be reimbursed for benefits in kind under the terms of Regulations (EEC) No 1408/71 and (EEC) No 574/72 (c) The Agreement of 3 February 1999 laying down the special conditions for administration and settling of reciprocal debts for sickness benefits under the terms of Regulations (EEC) No 1408/71 and (EEC) No 574/72 FRANCE \u2014 PORTUGAL The Agreement of 28 April 1999 laying down special detailed rules governing the administration and settlement of reciprocal claims for medical treatment pursuant to Regulations (EEC) No 1408/71 and EEC No 574/72 FRANCE \u2014 UNITED KINGDOM (a) The Exchange of Letters of 25 March and 28 April 1997 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) (b) The Agreement of 8 December 1998 on the specific methods of determining the amounts to be reimbursed for benefits in kind pursuant to Regulations (EEC) No 1408/71 and (EEC) No 574/72 ITALY \u2014 LUXEMBOURG Article 4(5) and (6) of the Administrative Arrangement of 19 January 1955 on the implementing provisions of the General Convention on Social Security (sickness insurance for agricultural workers) ITALY \u2014 NETHERLANDS The Agreement of 24 December 1996/27 February 1997 on Article 36(3) and Article 63(3) of Regulation (EEC) No 1408/71 ITALY \u2014 UNITED KINGDOM The Arrangement signed on 15 December 2005 between the Competent Authorities of the Italian Republic and of the United Kingdom under Articles 36(3) and 63(3) of Regulation (EEC) No 1408/71 establishing other methods of reimbursement of the costs of benefits in kind provided under this Regulation by both countries with effect from 1 January 2005 LUXEMBOURG \u2014 NETHERLANDS The Agreement of 1 November 1976 on the waiving of reimbursement of the costs of administrative checks and medical examinations adopted pursuant to Article 105(2) of Regulation (EEC) No 574/72 LUXEMBOURG \u2014 SWEDEN The Arrangement of 27 November 1996 on the reimbursement of expenditure in the field of social security LUXEMBOURG \u2014 UNITED KINGDOM The Exchange of Letters of 18 December 1975 and 20 January 1976 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs entailed in administrative checks and medical examinations referred to in Article 105 of Regulation (EEC) No 574/72) HUNGARY \u2014 UNITED KINGDOM The Arrangement finalised on 1 November 2005 between the Competent Authorities of the Republic of Hungary and of the United Kingdom under Articles 35(3) and 41(2) of Regulation (EEC) No 883/2004 establishing other methods of reimbursement of the costs of benefits in kind provided under that Regulation by both countries with effect from 1 May 2004 MALTA \u2014 UNITED KINGDOM The Arrangement finalised on 17 January 2007 between the Competent Authorities of Malta and of the United Kingdom under Articles 35(3) and 41(2) of Regulation (EEC) No 883/2004 establishing other methods of reimbursement of the costs of benefits in kind provided under that Regulation by both countries with effect from 1 May 2004 NETHERLANDS \u2014 PORTUGAL The Agreement of 11 December 1987 concerning the reimbursement of benefits in kind in the case of sickness and maternity NETHERLANDS \u2014 UNITED KINGDOM (a) The second sentence of Article 3 of the Administrative Arrangement of 12 June 1956 on the implementation of the Convention of 11 August 1954 (b) The Exchange of Letters of 25 April and 26 May 1986 concerning Article 36(3) of Regulation (EEC) No 1408/71 (reimbursement or waiver of reimbursement of expenditure for benefits in kind), as amended PORTUGAL \u2014 UNITED KINGDOM The Arrangement of 8 June 2004 establishing other methods of reimbursement of the costs of benefits in kind provided by both countries with effect from 1 January 2003 FINLAND \u2014 SWEDEN Article 15 of the Nordic Convention on Social Security of 18 August 2003: Agreement on the reciprocal waiver of refund pursuant to Articles 36, 63 and 70 of Regulation (EEC) No 1408/71 (cost of benefits in kind in respect of sickness and maternity, accidents at work and occupational diseases, and unemployment benefits) and Article 105 of Regulation (EEC) No 574/72 (costs of administrative checks and medical examinations) FINLAND \u2014 UNITED KINGDOM The Exchange of Letters 1 and 20 June 1995 concerning Articles 36(3) and 63(3) of Regulation (EEC) No 1408/71 (reimbursement or waiving of reimbursement of the cost of benefits in kind) and Article 105(2) of Regulation (EEC) 574/72 (waiving of reimbursement of the cost of administrative checks and medical examinations) SWEDEN \u2014 UNITED KINGDOM The Arrangement of 15 April 1997 concerning Article 36(3) and Article 63(3) of Regulation (EEC) No 1408/71 (reimbursement or waiving of reimbursement of the cost of benefits in kind) and Article 105(2) of Regulation (EEC) No 574/72 (waiving of refunds of the costs of administrative checks and medical examinations) ANNEX 2 Special schemes for civil servants (referred to in Articles 31 and 41 of the implementing Regulation) A. Special schemes for civil servants which are not covered by Title III, Chapter 1 of Regulation (EC) No 883/2004 concerning benefits in kind Germany Special sickness scheme for civil servants B. Special schemes for civil servants which are not covered by Title III, Chapter 1 of Regulation (EC) No 883/2004, with the exception of Article 19, paragraph 1 of Article 27 and Article 35, concerning benefits in kind Spain Special scheme of social security for civil servants Special scheme of social security for the armed forces Special scheme of social security for the court officials and administrative staff C. Special schemes for civil servants which are not covered by Title III, Chapter 2 of Regulation (EC) No 883/2004 concerning benefits in kind Germany Special accident scheme for civil servants ANNEX 3 Member States claiming the reimbursement of the cost of benefits in kind on the basis of fixed amounts (referred to in Article 63(1) of the implementing Regulation) IRELAND SPAIN ITALY MALTA THE NETHERLANDS PORTUGAL FINLAND SWEDEN UNITED KINGDOM ANNEX 4 Details of the database referred to in Article 88(4) of the implementing Regulation 1. Content of the database An electronic directory (URL) of the bodies concerned shall indicate: (a) the names of the bodies in the official language(s) of the Member State as well as in English (b) the identification code and the EESSI electronic addressing (c) their function in respect of the definitions in Article 1(m), (q) and (r) of the basic Regulation and Article 1(a) and (b) of the implementing Regulation (d) their competence as regards the different risks, types of benefits, schemes and geographical coverage (e) which part of the basic Regulation the bodies are applying (f) the following contact details: postal address, telephone, telefax, e-mail address and the relevant URL address (g) any other information necessary for the application of the basic Regulation or the implementing Regulation. 2. Administration of the database (a) The electronic directory is hosted in EESSI at the level of the European Commission. (b) Member States are responsible for collecting and checking the necessary information of bodies and for the timely submission to the European Commission of any entry or change of the entries falling under their responsibility. 3. Access Information used for operational and administrative purposes is not accessible to the public. 4. Security All modifications to the database (insert, update, delete) shall be logged. Prior to accessing the Directory for the purposes of modifying entries, users shall be identified and authenticated. Prior to any attempt of a modification of an entry, the user\u2019s authorisation to perform this action will be checked. Any unauthorised action shall be rejected and logged. 5. Language Regime The general language regime of the database is English. The name of bodies and their contact details should also be inserted in the official language(s) of the Member State. ANNEX 5 Member States determining, on a reciprocal basis, the maximum amount of reimbursement referred to in the third sentence of Article 65(6) of the basic Regulation, on the basis of the average amount of unemployment benefits provided under their legislations in the preceding calendar year (referred to in Article 70 of the implementing Regulation) BELGIUM CZECH REPUBLIC GERMANY AUSTRIA SLOVAKIA FINLAND", "summary": "Social security system \u2014 Cooperation between EU countries Social security system \u2014 Cooperation between EU countries SUMMARY OF: Regulation (EC) No 987/2009 on coordinating social security systems WHAT IS THE AIM OF THIS REGULATION? It is an implementing regulation which modernises and simplifies the rules for applying Regulation (EC) No 883/2004 on the coordination of social security systems in the EU. In implementing Regulation (EC) No 883/2004, this regulation makes it easier for citizens to exercise their right to move freely in the EU for study, leisure or for professional reasons and guarantees that they are not disadvantaged in terms of social security. It repeals and replaces Regulation (EEC) No 574/72. KEY POINTS The regulation strengthens cooperation between EU countries\u2019 social security institutions* and improves the methods that they use to share information with one another. The regulation is divided into 5 titles some of which contain several chapters: Title I \u2014 General provisions Chapter I \u2014 definitions of various terms used in the regulation. Chapter II \u2014 rules on cooperation between EU countries\u2019 social security institutions: how institutions share data; how claimants interact with the social security institutions; the legal value of documents and supporting evidence issued in another EU country; the provisional application of legislation and the provisional granting of benefits (where there is a difference of view between institutions in different countries) and the provisional calculation of benefits and contributions. Chapter III \u2014 aspects such as arrangements between 2 or more EU countries: preventing the overlap of benefits; determining residence; aggregating periods of insurance, employment, self-employment or residence completed under the laws of an EU country; and how these should be added to those completed under the laws of another EU country (if applicable). Title II \u2014 Determination of the legislation applicable Under Title II, detailed rules are set out depending on which article (i.e. Articles 12 to 16) of Regulation (EC) No 883/2004 applies to the claimant (for example, Article 13 applies to people who are employed in 2 or more EU countries). Title III \u2014 Special rules concerning the various categories of benefits Chapter I \u2014 Sickness, maternity and equivalent benefits (for example, conditions for meeting the costs of sickness benefits in kind as part of scheduled treatments, i.e. treatments for which an insured person goes to another EU country other than that in which he/she is insured or resident). Chapter II \u2014 Benefits in respect of accidents at work and occupational disease. Chapter III \u2014 Death grants. Chapter IV \u2014 Invalidity benefits and old-age and survivors\u2019 pensions. Chapter V \u2014 Unemployment benefits. Chapter VI \u2014 Family benefits. Title IV \u2014 Financial aspects Chapter I \u2014 Reimbursement of the cost of benefits in relation to Article 35 and Article 41 of Regulation (EC) No 883/2004 both of which concern reimbursements between institutions. Chapter II \u2014 Reimbursement of unemployment benefits pursuant to Article 65 of Regulation (EC) No 883/2004. Chapter III \u2014 Recovery of benefits provided but not due, recovery of provisional payments and contributions, offsetting and assistance with recovery. Title V \u2014 Miscellaneous, transitional and final provisions Title V covers aspects ranging from medical examinations and administrative checks, in cases when a claimant is staying in an EU country other than that in which the debtor institution is located, to the entry into force of the regulation. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 May 2010. BACKGROUND For more information, see: EU social security coordination (European Commission). Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted:Communication from the Commission \u2014 Towards a phased and coordinated approach for restoring freedom of movement and lifting internal border controls \u2014 COVID-19 KEY TERMS Social security institutions: these include institutions responsible for sickness, maternity, invalidity, retirement, accidents at work, unemployment, family benefits, as well as pre-retirement schemes. MAIN DOCUMENT Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (OJ L 284, 30.10.2009, pp. 1-42) Successive amendments to Regulation (EC) No 987/2009 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ L 166, 30.4.2004, pp. 1-123). Text republished in corrigendum (OJ L 200, 7.6.2004, pp. 1-49). See consolidated version. last update 02.06.2020"}
{"article": "31.12.2008 EN Official Journal of the European Union L 354/70 REGULATION (EC) No 1338/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on Community statistics on public health and health and safety at work (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) (3), stated that the statistical element of the information system on public health was to be developed in collaboration with Member States using, as necessary, the Community Statistical Programme to promote synergy and avoid duplication. Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the field of health (2008-2013) (4) indicated that its objective of generating and disseminating health information and knowledge would be pursued by actions to develop further a sustainable health monitoring system with mechanisms for collection of comparable data and information, with appropriate indicators, and to develop, with the Community Statistical Programme, the statistical element of this system. (2) Community information on public health has been developed systematically through the Community public health programmes. Building on this work, a list of European Community Health Indicators (ECHI) has now emerged providing an overview of health status, determinants of health and health systems. In order to make available the minimum statistical data set needed for the calculation of ECHI, Community statistics on public health should be consistent, when relevant and possible, with the developments and achievements resulting from Community action in the field of public health. (3) Council Resolution of 3 June 2002 on a new Community strategy on health and safety at work (2002-2006) (5) called on the Commission and the Member States to step up work in hand on harmonisation of statistics on accidents at work and occupational illnesses, so as to have available comparable data from which to make an objective assessment of the impact and effectiveness of the measures taken under the new Community strategy, as well as emphasised, in a specific section, the need to take into account the increase in the proportion of women on the labour market and to respond to their specific needs in relation to policies on health and safety at work. In addition, in its Resolution of 25 June 2007 on a new Community strategy on health and safety at work (2007-2012) (6) the Council called on the Commission to cooperate with the legislative authorities in establishing an appropriate European statistical system in the area of occupational safety and health, which takes account of the different national systems and avoids imposing additional administrative burdens. Finally, in its Recommendation of 19 September 2003 concerning the European schedule of occupational diseases (7), the Commission recommended that the Member States progressively make their statistics on occupational diseases compatible with the European schedule, in accordance with the work being done on the system of harmonising European statistics on occupational diseases. (4) The Barcelona European Council of 15 and 16 March 2002 recognised three guiding principles for the reform of health care systems: accessibility for all, high-quality care and long-term financial sustainability. The Commission Communication of 20 April 2004 entitled \u2018Modernising social protection for the development of high-quality, accessible and sustainable health care and long-term care: support for the national strategies using the \u201copen method of coordination\u201d\u2019, proposed starting work to identify possible indicators for joint objectives for developing care systems on the basis of activities undertaken in the context of the Community action programme for health, of Eurostat's health statistics and of cooperation with international organisations. In establishing such indicators, specific attention should be devoted to the use and comparability of self-assessed health as reported in surveys. (5) Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (8) includes an action on environment and health and quality of life as a key environmental priority, calling for the definition and development of indicators of health and environment. In addition, the Council Conclusions on Structural Indicators of 8 December 2003 requested that indicators on biodiversity and health be included, under the title \u2018environment\u2019, in the structural indicators database used for the annual Spring Report to the European Council; health and safety at work indicators are also included in this database, under the title \u2018employment\u2019. The set of sustainable development indicators adopted by the Commission in 2005 also contains a theme on public health indicators. (6) The Environment and Health Action Plan 2004-2010 recognises the need to improve the quality, comparability and accessibility of data on health status for diseases and disorders linked to the environment, using the Community Statistical Programme. (7) Council Resolution of 15 July 2003 on promoting the employment and social integration of people with disabilities (9) called on the Member States and the Commission to collect statistical material on the situation of people with disabilities, including on the development of services and benefits for this group. In addition, the Commission in its Communication of 30 October 2003 entitled \u2018Equal opportunities for people with disabilities: A European Action Plan\u2019, decided to develop context indicators, which are comparable across Member States, in order to assess the effectiveness of disability policies. It indicated that maximum use should be made of sources and structures of the European Statistical System, in particular through development of harmonised survey modules, to acquire the internationally comparable statistical information needed for monitoring progress. (8) In order to ensure relevance and comparability of the data and avoid duplication of work, the statistical activities of the Commission (Eurostat) in the area of public health and health and safety at work should be carried out in cooperation with the United Nations and its special organisations, such as the World Health Organisation (WHO) and the International Labour Organisation (ILO), as well as the Organisation for Economic Cooperation and Development (OECD), when relevant and possible. (9) The Commission (Eurostat) already collects on a regular basis statistical data on public health and health and safety at work from the Member States, which provide such data on a voluntary basis. It also collects data on those areas through other sources. Those activities are developed in close collaboration with Member States. In the area of public health statistics in particular, development and implementation are steered and organised according to a partnership structure between the Commission (Eurostat) and Member States. However, greater accuracy and reliability, coherence and comparability, coverage, timeliness and punctuality of the existing statistical data collections are still needed and it is also necessary to ensure that further collections agreed and developed with the Member States are implemented in order to achieve the minimum statistical data set necessary at Community level in the areas of public health and health and safety at work. (10) The production of specific Community statistics is governed by the rules set out in Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (10). (11) This Regulation ensures full respect for the right to the protection of personal data as provided for in Article 8 of the Charter of Fundamental Rights of the European Union (11). (12) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (12) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (13) apply in the context of this Regulation. The statistical requirements to which Community action in the field of public health, national strategies for the development of high-quality, accessible and sustainable health care and Community strategy on health and safety at work gives rise, as well as requirements arising in connection with structural indicators, sustainable development indicators and ECHI and other sets of indicators which it is necessary to develop for the purpose of monitoring Community and national political actions and strategies in the areas of public health and health and safety at work, constitute a substantial public interest. (13) The transmission of data subject to statistical confidentiality is governed by the rules set out in Regulation (EC) No 322/97 and in Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (14). Measures which are taken in accordance with those Regulations ensure the physical and logical protection of confidential data and ensure that no unlawful disclosure and non-statistical use occur when Community statistics are produced and disseminated. (14) In the production and dissemination of Community statistics under this Regulation, the national and Community statistical authorities should take account of the principles set out in the European Statistics Code of Practice, which was adopted by the Statistical Programme Committee on 24 February 2005. (15) Since the objective of this Regulation, namely the establishment of a common framework for the systematic production of Community statistics on public health and health and safety at work, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (16) Recognising that the organisation and management of health care systems are matters of national competence and that the implementation of Community legislation on workplaces and labour conditions is primarily the responsibility of Member States, this Regulation ensures full respect for Member States' competence for public health and health and safety at work. (17) It is important that gender and age be included in the breakdown variables as this allows the impact of gender and age differences on health and safety at work to be taken into account. (18) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (15). (19) In particular, the Commission should be empowered to adopt the implementing measures covering characteristics of certain subjects and their breakdown, the reference periods, intervals and time limits for data provision as well as provision of metadata. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (20) Complementary financing for the collection of data in the fields of public health and health and safety at work are to be provided respectively within the frameworks of the second programme of Community action in the field of health (2008-13) and of the Community Programme for Employment and Social Solidarity \u2014 Progress (16). Within those frameworks, financial resources should be used to help Member States in further building up national capacities to implement improvements and new tools for statistical data collection in the fields of public health and health and safety at work. (21) The European Data Protection Supervisor has been consulted. (22) The Statistical Programme Committee has been consulted in accordance with Article 3(1) of Decision 89/382/EEC, Euratom (17), HAVE ADOPTED THIS REGULATION: Article 1 Subject matter 1. This Regulation establishes a common framework for the systematic production of Community statistics on public health and health and safety at work. The statistics shall be produced in compliance with standards on impartiality, reliability, objectivity, cost-effectiveness and statistical confidentiality. 2. The statistics shall include, in the form of a harmonised and common data set, information required for Community action in the field of public health, for supporting national strategies for the development of high-quality, universally accessible and sustainable health care as well as for Community action in the field of health and safety at work. 3. The statistics shall provide data for structural indicators, sustainable development indicators and European Community Health Indicators (ECHI), as well as for the other sets of indicators which it is necessary to develop for the purpose of monitoring Community actions in the fields of public health and health and safety at work. Article 2 Scope Member States shall supply to the Commission (Eurostat) statistics on the following domains: \u2014 health status and health determinants, as defined in Annex I, \u2014 health care, as defined in Annex II, \u2014 causes of death, as defined in Annex III, \u2014 accidents at work, as defined in Annex IV, \u2014 occupational diseases and other work-related health problems and illnesses, as defined in Annex V. Article 3 Definitions For the purpose of this Regulation: (a) \u2018Community statistics\u2019 shall have the meaning assigned to it by the first indent of Article 2 of Regulation (EC) No 322/97; (b) \u2018production of statistics\u2019 shall have the meaning assigned to it by the second indent of Article 2 of Regulation (EC) No 322/97; (c) \u2018public health\u2019 shall mean all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and universal access to, health care as well as health care expenditure and financing, and the causes of mortality; (d) \u2018health and safety at work\u2019 shall mean all elements related to the prevention and protection of the health and safety of workers at work in their current or past activities, in particular accidents at work, occupational diseases and other work-related health problems and illnesses; (e) \u2018microdata\u2019 shall mean individual statistical records; (f) \u2018transmission of confidential data\u2019 shall mean transmission between national authorities and the Community authority of confidential data which do not permit direct identification, in accordance with Article 14 of Regulation (EC) No 322/97 and with Regulation (Euratom, EEC) No 1588/90; (g) \u2018personal data\u2019 shall mean any information relating to an identified or identifiable natural person, in accordance with the Article 2(a) of Directive 95/46/EC. Article 4 Sources Member States shall compile data concerning public health and health and safety at work from sources which shall, depending on the domains and subjects and on the characteristics of the national systems, consist of either household or similar surveys or survey modules, or national administrative or reporting sources. Article 5 Methodology 1. The methods used for the implementation of the data collections shall take into consideration, including in the case of preparatory activities, national experience and expertise, and national specificities, capacities and existing data collections, in the framework of the collaborative networks and other European Statistical System (ESS) structures with Member States set up by the Commission (Eurostat). The methodologies for regular data collections which result from projects with a statistical dimension carried out under other Community programmes such as the public health or the research programmes shall also be taken into consideration. 2. The statistical methodologies and data collections to be developed for the compilation of statistics on public health and health and safety at work at Community level shall take into consideration the need for coordination, whenever relevant, with the activities of international organisations in the field, with a view to ensuring international comparability of statistics and consistency of data collections as well as avoiding duplication of effort and of deliveries of data by Member States. Article 6 Pilot studies and cost-benefit analyses 1. Whenever data are required in addition to those already collected and to those for which methodologies already exist, or when insufficient quality of data is identified in the domains referred to in Article 2, the Commission (Eurostat) shall institute pilot studies to be completed on a voluntary basis by the Member States. The purpose of such pilot studies shall be to test the concepts and methods and to assess the feasibility of the related data collections, including statistical quality, comparability and cost effectiveness, in accordance with the principles set up by the European Statistics Code of Practice. 2. Whenever preparation of an implementing measure is envisaged in accordance with the regulatory procedure with scrutiny referred to in Article 10(2), a cost-benefit analysis, taking into account the benefits of the availability of the data in relation to the cost of the data collection and the burden on Member States, shall be carried out. 3. The Commission (Eurostat) shall prepare a report evaluating the findings of the pilot studies and/or cost benefit analysis, including the effects and implications of national specificities, in cooperation with Member States, in the framework of the collaborative networks and other ESS structures. Article 7 Transmission, treatment and dissemination of data 1. When necessary for the production of Community statistics, Member States shall transmit the confidential microdata or, depending on the domain and subject concerned, the aggregated data, in accordance with the provisions on transmission of data subject to confidentiality set out in Regulation (EC) No 322/97 and in Regulation (Euratom, EEC) No 1588/90. Those provisions shall apply to the treatment of the data by the Commission (Eurostat), in so far as the data are considered confidential within the meaning of Article 13 of Regulation (EC) No 322/97. Member States shall ensure that the transmitted data do not permit the direct identification of the statistical units (individuals) and that personal data are protected in compliance with the principles laid down in Directive 95/46/EC. 2. Member States shall transmit the data and metadata required by this Regulation in electronic form, in accordance with an interchange standard agreed between the Commission (Eurostat) and the Member States. The data shall be provided in accordance with the time limits set out, at the intervals provided for, and in respect of the reference periods indicated in the Annexes or in the implementing measures adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). 3. The Commission (Eurostat) shall take the necessary steps to improve the dissemination, accessibility and documentation of the statistical information, in accordance with the principles of comparability, reliability and statistical confidentiality laid down in Regulation (EC) No 322/97 and with Regulation (EC) No 45/2001. Article 8 Quality assessment 1. For the purpose of this Regulation, the following quality assessment dimensions shall apply to the data to be transmitted: (a) \u2018relevance\u2019 shall refer to the degree to which statistics meet the current and potential needs of users; (b) \u2018accuracy\u2019 shall refer to the closeness of estimates to the unknown true values; (c) \u2018timeliness\u2019 shall refer to the time lag between the availability of the information and the event or phenomenon it describes; (d) \u2018punctuality\u2019 shall refer to the time lag between the date of the release of the data and the target date when it should have been delivered; (e) \u2018accessibility\u2019 and \u2018clarity\u2019 shall refer to the conditions and modalities by which users can obtain, use and interpret data; (f) \u2018comparability\u2019 shall refer to the measurement of the impact of differences in applied statistical concepts and measurement tools and procedures when statistics are compared between geographical areas, sectoral domains or over time; (g) \u2018coherence\u2019 shall refer to the adequacy of the data to be reliably combined in different ways and for various uses. 2. Every five years each Member State shall provide the Commission (Eurostat) with a report on the quality of the data transmitted. The Commission (Eurostat) shall assess the quality of data transmitted and publish the reports. Article 9 Implementing measures 1. The implementing measures shall cover: (a) the characteristics, namely variables, definitions and classifications of the subjects, covered in Annexes I to V; (b) the breakdown of characteristics; (c) the reference periods, intervals and time limits for data provision; (d) the provision of metadata. These measures shall take account of, in particular, the provisions of Article 5, Article 6(2) and (3) and Article 7(1), as well as the availability, suitability and the legal context of existing Community data sources after examination of all sources related to the respective domains and subjects. These measures designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). 2. If necessary, derogations and transition periods for Member States, both to be based upon objective grounds, shall be adopted in accordance with the regulatory procedure referred to in Article 10(3). Article 10 Committee 1. The Commission shall be assisted by the Statistical Programme Committee set up by Decision 89/382/EEC, Euratom. 2. Where reference is made to this paragraph, Articles 5a(1) to (4) and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. Article 11 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 December 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President B. LE MAIRE (1) OJ C 44, 16.2.2008, p. 103. (2) Opinion of the European Parliament of 13 November 2007 (OJ C 282 E, 6.11.2008, p. 109), Council Common Position of 2 October 2008 (OJ C 280 E, 4.11.2008, p. 1) and Position of the European Parliament of 19 November 2008 (not yet published in the Official Journal). (3) OJ L 271, 9.10.2002, p. 1. (4) OJ L 301, 20.11.2007, p. 3. (5) OJ C 161, 5.7.2002, p. 1. (6) OJ C 145, 30.6.2007, p. 1. (7) OJ L 238, 25.9.2003, p. 28. (8) OJ L 242, 10.9.2002, p. 1. (9) OJ C 175, 24.7.2003, p. 1. (10) OJ L 52, 22.2.1997, p. 1. (11) OJ C 303, 14.12.2007, p. 1. (12) OJ L 281, 23.11.1995, p. 31. (13) OJ L 8, 12.1.2001, p. 1. (14) OJ L 151, 15.6.1990, p. 1. (15) OJ L 184, 17.7.1999, p. 23. (16) Decision No 1672/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Community Programme for Employment and Social Solidarity \u2014 Progress (OJ L 315, 15.11.2006, p. 1). (17) Council Decision 89/382/EEC, Euratom of 19 June 1989 establishing a Committee on the Statistical Programmes of the European Communities (OJ L 181, 28.6.1989, p. 47). ANNEX I Domain: Health status and health determinants (a) Aims The aim of this domain is the provision of statistics on health status and determinants. (b) Scope This domain covers the statistics on health status and health determinants that are based on self-assessment and compiled from population surveys such as the European Health Interview Survey (EHIS), as well as other statistics compiled from administrative sources such as those on morbidity or accidents and injuries. Persons living in institutions as well as children aged 0-14 years shall be included, when appropriate and at the relevant ad hoc intervals, subject to successful prior pilot studies. (c) Reference periods, intervals and time limits for data provision Statistics shall be provided every five years from the EHIS; a different frequency may be needed for other data collections, such as those on morbidity or accidents and injuries, as well as for some specific survey modules; the measures relating to the first reference year, the interval and the time limit for provision of the data shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). (d) Subjects covered The harmonised and common data set to be provided shall cover the following list of subjects: \u2014 health status, including health perceptions, physical and mental functioning, limitations and disability, \u2014 diagnosis-specific morbidity, \u2014 protection against possible pandemics and transmissible diseases, \u2014 accidents and injuries, including those related to consumer safety, and, whenever possible, alcohol- and drug-related harm, \u2014 lifestyle, such as physical activity, diet, smoking, alcohol consumption and drug-use, and environmental, social and occupational factors, \u2014 access and use of preventive and curative health care facilities, as well as of long-term care services (population survey), \u2014 background demographic and socio-economic information on the individuals. Not all subjects are necessarily to be covered at the time of each data provision. The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). The implementation of Health Examination Surveys shall be optional in the framework of this Regulation. The average length of the interview per household shall not exceed one hour for the EHIS and 20 minutes for the other survey modules. (e) Metadata The measures relating to the provision of metadata, including metadata concerning characteristics of surveys and other sources used, population covered and information about any national specificity essential for the interpretation and compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). ANNEX II Domain: Health care (a) Aims The aim of this domain is the provision of statistics on health care. (b) Scope This domain covers the sum of activities performed either by institutions or individuals pursuing, through the application of medical, paramedical and nursing knowledge and technology, the goal of health, including long-term care, as well as related administration and management activities. The data shall be compiled mainly from administrative sources. (c) Reference periods, intervals and time limits for data provision Statistics shall be provided annually. The measures relating to the first reference year, the interval and the time limit for provision of the data shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). (d) Subjects covered The harmonised and common data set to be provided shall cover the following list of subjects: \u2014 health care facilities, \u2014 health care human resources, \u2014 health care utilisation, individual and collective services, \u2014 health care expenditure and financing. Not all subjects are necessarily to be covered at the time of each data provision. The data set shall be established following the relevant international classifications and taking into consideration the circumstances and practices in Member States. The mobility of patients, namely their use of health care facilities in a country other than their country of residence, and of health professionals, such as those practising their profession outside the country where they obtained their first licence, shall be considered in the data collections. The quality of health care shall also be considered in the data collection. The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). (e) Metadata The measures relating to the provision of metadata, including metadata concerning characteristics of sources and compilations used, population covered and information about any national specificity essential for the interpretation and compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). ANNEX III Domain: Causes of death (a) Aims The aim of this domain is the provision of statistics on the causes of death. (b) Scope This domain covers the causes of death statistics as derived from national medical death certificates taking into account WHO recommendations. The statistics to be compiled refer to the underlying cause which is defined by WHO as \u2018the disease or injury which initiated the train of morbid events leading directly to death, or the circumstances of the accident or violence which produced the fatal injury\u2019. The statistics shall be compiled for all deaths and stillbirths occurring in each Member State, distinguishing residents and non-residents. Whenever possible, data on causes of death for residents dying abroad shall be included in the statistics of their country of residence. (c) Reference periods, intervals and time limits for data provision Statistics shall be provided annually. The measures relating to the first reference year shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). The data shall be submitted no later than 24 months after the end of the reference year. Provisional or estimated data can be provided earlier. In the case of public-health incidents, additional special data collections may be established, either for all deaths or for specific causes of death. (d) Subjects covered The harmonised and common data set to be provided shall cover the following list of subjects: \u2014 characteristics of the deceased, \u2014 region, \u2014 characteristics of the death, including the underlying cause of death. The causes of death data set shall be established in the framework of the WHO International Classification of Diseases and shall follow the Eurostat rules and the UN and WHO recommendations for population statistics. The provision of data relating to the characteristics of stillbirths shall be on a voluntary basis. Provision of data relating to neonatal deaths (deaths up to the age of 28 days) shall recognise national differences in practice regarding the recording of multiple causes of death. The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). (e) Metadata The measures relating to the provision of metadata, including metadata concerning population covered and information about any national specificity essential for the interpretation and compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). ANNEX IV Domain: Accidents at work (a) Aims The aim of this domain is the provision of statistics on accidents at work. (b) Scope An accident at work is defined as \u2018a discrete occurrence in the course of work which leads to physical or mental harm\u2019. The data shall be collected, for the entire workforce, for fatal accidents at work and accidents at work resulting in more than three days of absence from work, using administrative sources complemented with relevant additional sources whenever necessary and feasible for specific groups of workers or specific national situations. A limited subset of basic data on accidents with less than four days of absence may be collected, when available and on an optional basis, in the framework of the collaboration with the ILO. (c) Reference periods, intervals and time limits for data provision Statistics shall be provided annually. The measures relating to the first reference year shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). The data shall be submitted no later than 18 months after the end of the reference year. (d) Subjects covered The harmonised and common microdata set to be provided shall cover the following list of subjects: \u2014 characteristics of the injured person, \u2014 characteristics of the injury, including severity (days lost), \u2014 characteristics of the enterprise including economic activity, \u2014 characteristics of the workplace, \u2014 characteristics of the accident, including the sequence of events characterising the causes and circumstances of the accident. The accidents-at-work data set shall be established in the framework of the specifications laid down by the European Statistics on Accidents at Work (ESAW) methodology, taking into consideration the circumstances and practices in Member States. The provision of data relating to the nationality of the injured person, the size of the enterprise and the time of the accident shall be on a voluntary basis. Concerning the ESAW-methodology Phase III subjects, namely the workplace and the sequence of events characterising the causes and circumstances of the accident, a minimum of three variables shall be provided. Member States should also supply more data conforming to the ESAW Phase III specifications on a voluntary basis. The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). (e) Metadata The measures relating to the provision of metadata, including metadata concerning population covered, the declaration rates for accidents at work and, when relevant, sampling characteristics, as well as information about any national specificity essential for the interpretation and compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). ANNEX V Domain: Occupational diseases and other work-related health problems and illnesses (a) Aims The aim of this domain is the provision of statistics on recognised cases of occupational disease and other work-related health problems and illnesses. (b) Scope \u2014 A case of occupational disease is defined as a case recognised by the national authorities responsible for recognition of occupational diseases. The data shall be collected for incident occupational diseases and deaths due to occupational disease. \u2014 Work-related health problems and illnesses are those health problems and illnesses which can be caused, worsened or jointly caused by working conditions. This includes physical and psychosocial health problems. A case of work-related health problem and illness does not necessarily refer to recognition by an authority and the related data shall be collected from existing population surveys such as the European Health Interview Survey (EHIS) or other social surveys. (c) Reference periods, intervals and time limits for data provision For occupational diseases, statistics shall be provided annually and submitted no later than 15 months after the end of the reference year. The measures relating to the reference periods, the intervals and the time limits for provision of the other data collections shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). (d) Subjects covered The harmonised and common data set to be provided for occupational diseases shall cover the following list of subjects: \u2014 characteristics of the diseased person, including gender and age, \u2014 characteristics of the disease, including severity, \u2014 characteristics of the enterprise and workplace, including economic activity, \u2014 characteristics of the causative agent or factor. The occupational diseases data set shall be established in the framework of the specifications laid down by the European Occupational Diseases Statistics (EODS) methodology, taking into consideration the circumstances and practices in Member States. The harmonised and common data set to be provided for work-related health problems shall cover the following list of subjects: \u2014 characteristics of the person suffering the health problem, including gender, age and employment status, \u2014 characteristics of the work-related health problem, including severity, \u2014 characteristics of the enterprise and workplace, including size and economic activity, \u2014 characteristics of the agent or factor that caused the health problem or made it worse. Not all subjects are necessarily to be covered at the time of each data provision. The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). (e) Metadata The measures relating to the provision of metadata, including metadata concerning population covered and information about any national specificity essential for the interpretation and compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2).", "summary": "Statistics on public health/health & safety at work Statistics on public health/health & safety at work SUMMARY OF: Regulation (EC) No 1338/2008 on Community statistics on public health and health and safety at work WHAT IS THE AIM OF THE REGULATION? It sets rules for how statistics on public health and health and safety at work should be collected and presented to provide comparable data across all European Union (EU) Member States. This will help the EU formulate effective public health policy and support national strategies in this field. KEY POINTS The statistics collected by Member States, Liechtenstein, Iceland and Norway are sent to the EU\u2019s statistical office, Eurostat. Statistics are collected on the following subjects. Health and factors affecting it: health perceptions;physical and mental functioning and disability;morbidity* rates, broken down by diagnosis;accidents and injuries;lifestyle (exercise, diet, smoking, alcohol, drug use, etc.) and environmental, social and occupational factors;access to, and use of, healthcare facilities;demographic and socio-economic information on individuals. Healthcare: facilities;staff;cost and financing. Causes of death: the characteristics of the deceased;region;underlying causes of death. Accidents at work, occupational diseases and other work-related health problems: the person affected;the injury or illness and its severity;the organisation and workplace;causes and factors involved. Regulation (EC) No 1338/2008 was followed by several implementing regulations, laying down more detailed rules and procedures on other aspects of the collection of health statistics: Regulation (EU) No 328/2011 \u2013 registered deaths and stillbirths in each Member State; Regulation (EU) No 349/2011 \u2013 collection of statistics on accidents at work; Regulation (EU) No 141/2013 \u2013 European health interview survey; Regulation (EU) No 2015/359 \u2013 production of statistics on healthcare expenditure (for the reference period 2014\u20132020); Regulation (EU) 2021/1901 \u2013 production of statistics on healthcare expenditure (with 2021 as the first reference year). FROM WHEN DOES THE REGULATION APPLY? It has applied since 20 January 2009. BACKGROUND For further information, see: Health statistics overview (Eurostat) European health interview survey \u2013 methodology (Eurostat) Accidents at work statistics (Eurostat). KEY TERMS Morbidity. The prevalence of sickness or of a specific disease in a geographical area. MAIN DOCUMENT Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (OJ L 354, 31.12.2008, pp. 70\u201381). Successive amendments to Regulation (EC) No 1338/2008 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Regulation (EU) 2021/1901 of 29 October 2021 implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council as regards statistics on health care expenditure and financing (OJ L 387, 3.11.2021, pp. 110\u2013119). Commission Regulation (EU) 2015/359 of 4 March 2015 implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council as regards statistics on healthcare expenditure and financing (OJ L 62, 6.3.2015, pp. 6\u201315). Commission Regulation (EU) No 141/2013 of 19 February 2013 implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council on Community statistics on public health and health and safety at work, as regards statistics based on the European Health Interview Survey (EHIS) (OJ L 47, 20.2.2013, pp. 20\u201348). See consolidated version. Commission Regulation (EU) No 349/2011 of 11 April 2011 implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council on Community statistics on public health and health and safety at work, as regards statistics on accidents at work (OJ L 97, 12.4.2011, pp. 3\u20138). Commission Regulation (EU) No 328/2011 of 5 April 2011 implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council on Community statistics on public health and health and safety at work, as regards statistics on causes of death (OJ L 90, 6.4.2011, pp. 22\u201324). last update 08.02.2022"}
{"article": "4.6.2008 EN Official Journal of the European Union L 145/234 REGULATION (EC) No 453/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2008 on quarterly statistics on Community job vacancies (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the European Central Bank (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) On 8 December 2003, the Council endorsed the development and publication of a structural indicator on job vacancies. (2) The Action Plan on EMU Statistical Requirements, which was endorsed by the Council on 29 September 2000, and subsequent progress reports on the implementation of that plan, identified as a priority the development of a legal basis covering job vacancy statistics. (3) The Employment Committee established by Council Decision 2000/98/EC (4) endorses the need for an indicator for job vacancies in order to monitor the European Employment Strategy laid down in Council Decision 2005/600/EC of 12 July 2005 on Guidelines for the employment policies of the Member States (5). (4) Decision No 1672/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Community Programme for Employment and Social Solidarity \u2014 Progress (6), provides for the financing of the relevant actions, including, as specified therein, improving the understanding of the employment situation and prospects, in particular through analysis and studies and the development of statistics and common indicators within the framework of the European Employment Strategy. (5) Data on job vacancies broken down, inter alia, by economic activity are required by the Commission in the framework of the European Employment Strategy for monitoring and analysis of the level and structure of labour demand. (6) Readily available quarterly data on job vacancies are required by the Commission and by the European Central Bank to monitor short-term changes in job vacancies. Seasonally adjusted job vacancy data facilitate the interpretation of quarterly changes. (7) Data provided on job vacancies should be relevant and complete, accurate and comprehensive, timely, coherent, comparable, and readily accessible to users. (8) The benefits of collecting complete data at Community level on all segments of the economy should be balanced against the reporting possibilities of, and the response burden on, small and medium-sized enterprises in particular. (9) Particular efforts should be made to include in the statistics as soon as possible all data concerning units with fewer than 10 employees. (10) To determine the scope of the statistics to be compiled and the level of detail required by economic activity, it is necessary to apply the version of the statistical classification system for economic activities in the Community (NACE) that is currently in force. (11) In the production and dissemination of Community statistics under this Regulation, the national and Community statistical authorities should take account of the principles set out in the European Statistics Code of Practice, which was adopted by the Statistical Programme Committee established by Council Decision 89/382/EEC, Euratom (7) on 24 February 2005 and attached to the Recommendation of the Commission on the independence, integrity and accountability of the national and Community statistical authorities. (12) It is important that the data be shared with the social partners at national and Community level and that the social partners be informed concerning the implementation of this Regulation. Furthermore, Member States should make a particular effort to ensure that school career guidance services and vocational training bodies receive the data. (13) Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (8) provides a general legislative framework for the production of Community statistics and applies, therefore, to the production of job vacancy statistics. (14) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9). (15) In particular, the Commission should be empowered to define certain concepts; determine certain reference dates, formats and deadlines; set out the framework for feasibility studies, and adopt measures pursuant to the results of those studies. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (16) Since the objective of this Regulation, namely the production of Community job vacancy statistics, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (17) The Statistical Programme Committee has been consulted in accordance with Article 3 of Decision 89/382/EEC, Euratom, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. This Regulation lays down the requirements for the regular quarterly production of statistics on Community job vacancies. 2. Each Member State shall submit to the Commission (Eurostat) data on job vacancies at least for business units with one employee or more. Subject to paragraph 3, the data shall cover all economic activities defined by the common classification system for economic activities in the Community (NACE) in force, except for the activities of households as employers and the activities of extraterritorial organisations and bodies. Covering agriculture, forestry and fishing activities, as defined by the NACE in force, shall be optional. Member States that wish to provide data for those sectors shall do so in accordance with this Regulation. Owing to the growing importance of personal care services (residential care activities and social work activities without accommodation) for job creation, Member States are also requested to transmit, on an optional basis, data on job vacancies for such services. The data shall be broken down by economic activity in accordance with the NACE in force at section level. 3. Covering public administration and defence, compulsory social security, education, human health and social work activities, arts, entertainments and recreation and activities of membership organisations, repair of computers and personal and household goods and other personal service activities, as defined by the NACE in force, within the scope of this Regulation, and of units with fewer than 10 employees, shall be determined taking into account the feasibility studies referred to in Article 7. Article 2 Definitions For the purposes of this Regulation, the following definitions shall apply: 1. \u2018job vacancy\u2019 shall mean a paid post that is newly created, unoccupied, or about to become vacant: (a) for which the employer is taking active steps and is prepared to take further steps to find a suitable candidate from outside the enterprise concerned; and (b) which the employer intends to fill either immediately or within a specific period of time. The concepts \u2018active steps to find a suitable candidate\u2019 and \u2018specific period of time\u2019 shall be defined in accordance with the regulatory procedure with scrutiny referred to in Article 9(2). The statistics provided shall distinguish, on an optional basis, between vacancies for fixed-term and permanent jobs; 2. \u2018occupied post\u2019 shall mean a paid post within the organisation to which an employee has been assigned; 3. \u2018metadata\u2019 shall mean the explanations needed to interpret the changes in the data arising from either methodological or technical changes; 4. \u2018back data\u2019 shall mean the historical data covering the specifications given in Article 1. Article 3 Reference dates and technical specifications 1. Member States shall compile the quarterly data with reference to specific reference dates, which shall be determined in accordance with the regulatory procedure with scrutiny referred to in Article 9(2). 2. Member States shall provide data on occupied posts in order to standardise job vacancy data for comparative purposes. 3. Member States shall be required to apply seasonal adjustment procedures to the quarterly job vacancy data. The seasonal adjustment procedures required shall be determined in accordance with the regulatory procedure referred to in Article 9(3). Article 4 Sources 1. Member States shall produce the data using business surveys. Other sources, such as administrative data, may be used provided that they are appropriate in terms of quality, in accordance with Article 6. The sources of all data provided shall be specified. 2. Member States may supplement the sources referred to in paragraph 1 with reliable statistical estimation procedures. 3. Community sample schemes may be established and coordinated by the Commission (Eurostat) in order to produce Community estimates where national sample schemes do not meet the Community requirements with regard to quarterly data collection. The detail of those schemes, their approval and their implementation shall be specified in accordance with the regulatory procedure referred to in Article 9(3). Member States may take part in Community sample schemes when such schemes create possibilities for substantial reductions in the cost of the statistical systems or the burden on business entailed in meeting the Community requirement. Article 5 Data transmission 1. Member States shall transmit the data and metadata to the Commission (Eurostat) in a format and within transmission deadlines, which shall be determined in accordance with the regulatory procedure with scrutiny referred to in Article 9(2). The date of the first reference quarter shall also be determined in accordance with the regulatory procedure with scrutiny referred to in Article 9(2). Any revision of quarterly data for previous quarters shall be transmitted at the same time. 2. Member States shall also transmit back data for at least the four quarters preceding the quarter for which data is to be provided on the first data delivery. The totals shall be delivered no later than on the date of the first data transmission, and the breakdowns no more than one year thereafter. Where necessary, back data may be based on \u2018best estimates\u2019. Article 6 Quality assessment 1. For the purpose of this Regulation, the following quality assessment dimensions shall apply to the data transmitted: \u2014 \u2018relevance\u2019 shall refer to the degree to which statistics meet the current and potential needs of users, \u2014 \u2018accuracy\u2019 shall refer to the closeness of estimates to the unknown true values, \u2014 \u2018timeliness\u2019 and \u2018punctuality\u2019 shall refer to the delay between the availability of the information and the event or phenomenon it describes, \u2014 \u2018accessibility\u2019 and \u2018clarity\u2019 shall refer to the conditions and modalities by which users can obtain, use and interpret data, \u2014 \u2018comparability\u2019 shall refer to the measurement of the impact of differences in applied statistical concepts and measurement tools and procedures when statistics are compared between geographical areas or sectoral domains, or over time, \u2014 \u2018coherence\u2019 shall refer to the adequacy of the data to be reliably combined in different ways and for various uses. 2. Member States shall provide the Commission (Eurostat) with reports on the quality of the data transmitted. 3. In applying the quality assessment dimensions laid down in paragraph 1 to the data covered by this Regulation, the modalities, structure and periodicity of the quality reports shall be defined in accordance with the regulatory procedure referred to in Article 9(3). The Commission (Eurostat) shall assess the quality of the data transmitted. Article 7 Feasibility studies 1. The Commission (Eurostat) shall set out the appropriate framework for the establishment of a series of feasibility studies in accordance with the regulatory procedure with scrutiny referred to in Article 9(2). Those studies shall be undertaken by those Member States that have difficulties in providing data for: (a) units with fewer than 10 employees; and/or (b) the following activities: (i) public administration and defence; compulsory social security; (ii) education; (iii) human health and social work activities; (iv) arts, entertainments and recreation; and (v) activities of membership organisations, repair of computers and personal and household goods and other personal service activities. 2. Member States undertaking feasibility studies shall each submit a report on the results of those studies within 12 months of the entry into force of the Commission implementing measures referred to in paragraph 1. 3. As soon as possible after the results of the feasibility studies become available, in dialogue with the Member States, and within a reasonable time frame, the Commission shall adopt measures in accordance with the regulatory procedure with scrutiny referred to in Article 9(2). 4. Measures adopted pursuant to the results of the feasibility studies shall respect the principle of cost-effectiveness, as defined in Article 10 of Regulation (EC) No 322/97, including minimisation of the burden on respondents, and shall take into account initial implementation problems. Article 8 Financing 1. For the first three years of data collection Member States may receive a financial contribution from the Community towards the cost of the work involved. 2. The amount of the appropriations allocated annually for the financial contribution referred to in paragraph 1 shall be fixed as part of the annual budgetary procedures. 3. The budget authority shall grant the appropriations available for each year. 4. Further funding may be considered for implementation work with respect to the measures adopted further to the results of the feasibility studies. Article 9 Committee 1. The Commission shall be assisted by the Statistical Programme Committee. 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. Article 10 Report on implementation By 24 June 2010 and every three years thereafter, the Commission shall submit a report to the European Parliament and the Council on the implementation of this Regulation. That report shall assess the quality of the statistics provided by Member States as well as the quality of European aggregates and shall identify potential areas for improvement. Preferably within a year of the publication of the three-yearly report referred to in the first paragraph, Member States shall set out how they intend to address the potential areas for improvement identified in the Commission report. At the same time, Member States shall report on the implementation status of previous recommendations. Article 11 Publication of statistical data The statistics provided by the Member States and an analysis thereof shall be published on the Commission (Eurostat) Internet site on a quarterly basis. The Commission (Eurostat) shall ensure that as many European citizens as possible have access to the statistics and analyses, in particular through the EURES portal. Article 12 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 23 April 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J. LENAR\u010cI\u010c (1) OJ C 175, 27.7.2007, p. 11. (2) OJ C 86, 20.4.2007, p. 1. (3) Opinion of the European Parliament of 15 November 2007 (not yet published in the Official Journal) and Council Decision of 29 February 2008. (4) OJ L 29, 4.2.2000, p. 21. (5) OJ L 205, 6.8.2005, p. 21. (6) OJ L 315, 15.11.2006, p. 1. (7) OJ L 181, 28.6.1989, p. 47. (8) OJ L 52, 22.2.1997, p. 1. Regulation as amended by European Parliament and Council Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). (9) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).", "summary": "Quarterly statistics on job vacancies in EU countries Quarterly statistics on job vacancies in EU countries SUMMARY OF: Regulation (EC) No 453/2008 on quarterly statistics on job vacancies in the EU WHAT IS THE AIM OF THE REGULATION? It lays down the requirements for the regular quarterly production of statistics on job vacancies* in the European Union (EU). These quarterly data are intended for short-term business cycle analysis (i.e. monitoring the fluctuations in business activity in an economy over a period of time). KEY POINTS Since 2010, each EU country must submit to the European Commission (Eurostat) data on job vacancies for businesses with 1 employee or more. EU countries must transmit these data broken down by economic activity, within 70 days from the end of the quarter concerned. Scope The data cover all economic activities defined by the common classification system for economic activities in the EU\u2019s NACE* in force, except for the activities of households as employers and the activities of overseas organisations and bodies. Although covering agriculture, forestryand fishing activities , as defined by the NACE in force, is optional, EU countries wishing to provide data for those sectors must do so in accordance with this regulation. Owing to the growing importance of personal care services (residential care activities and social work activities without accommodation) for job creation, EU countries are also requested to transmit, on an optional basis, data on job vacancies in these areas. The data must be broken down by economic activity in accordance with the NACE in force at section level. Data are collected in the EU countries, Norway, Switzerland and the former Yugoslav Republic of Macedonia. Reference dates and specifications EU countries must compile the quarterly data with reference to specific reference dates. These are determined by the European Statistical System Committee, made up of national experts, which assists and is chaired by the European Commission. Countries must also provide data on occupied posts in order to standardise job vacancy data for comparative purposes. They must apply seasonal adjustments to the quarterly job vacancy data. Data transmission EU countries must transmit data to Eurostat in a format and within deadlines determined by the European Statistical System Committee. Quality assessment On receipt of the data from EU countries, Eurostat checks them for completeness and consistency. Financing EU countries were able to receive EU funding for the first three years of data collection as a contribution to the cost of the work involved. Reports Every 3 years, the Commission submits a report to the European Parliament and the Council on the implementation of the regulation. This assesses the quality of the statistics provided by EU countries and that of European aggregates, as well as identifying potential areas for improvement. Implementing acts Regulation (EC) No 1062/2008 sets out the procedures for seasonal adjustment of data and for quality reports. Regulation (EC) No 19/2009 defines a job vacancy, the reference dates for data collection, data transmission specifications and feasibility studies. FROM WHEN DOES THE REGULATION APPLY? It has applied since 24 June 2008. BACKGROUND EU policies in the area of job vacancies aim to improve the functioning of the labour market by trying to more closely match supply and demand. EURES, the European job mobility portal, seeks to make it easier to match jobseekers and employers. For more information, see: \u2018Job vacancy statistics\u2019 on Eurostat's website * KEY TERMS Vacancy: a paid post that is newly created, unoccupied, or about to become vacant. NACE classification: from the French Nomenclature statistique des activit\u00e9s \u00e9conomiques dans la Communaut\u00e9 europ\u00e9enne (the Statistical classification of economic activities in the European Community). Various versions have been developed since 1970. MAIN DOCUMENT Regulation (EC) No 453/2008 of the European Parliament and of the Council of 23 April 2008 on quarterly statistics on Community job vacancies (OJ L 145, 4.6.2008, pp. 234\u2013237) RELATED DOCUMENTS Commission Regulation (EC) No 1062/2008 of 28 October 2008 implementing Regulation (EC) No 453/2008 of the European Parliament and of the Council on quarterly statistics on Community job vacancies, as regards seasonal adjustment procedures and quality reports (OJ L 285, 29.10.2008, pp. 3\u20138) Commission Regulation (EC) No 19/2009 of 13 January 2009 implementing Regulation (EC) No 453/2008 of the European Parliament and of the Council on quarterly statistics on Community job vacancies, as regards the definition of a job vacancy, the reference dates for data collection, data transmission specifications and feasibility studies (OJ L 9, 14.1.2009, pp. 3\u20136) Report from the Commission to the European Parliament and the Council on implementation of the Regulation (EC) No 453/2008 of the European Parliament and of the Council on quarterly statistics on Community job vacancies (COM(2016) 449 final, 8.7.2016) last update 10.10.2016"}
{"article": "4.2.2009 EN Official Journal of the European Union L 35/32 REGULATION (EC) No 79/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 January 2009 on type-approval of hydrogen-powered motor vehicles, and amending Directive 2007/46/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured. To that end, a comprehensive Community type-approval system for motor vehicles is in place. The technical requirements for the type-approval of motor vehicles with regard to hydrogen propulsion should be harmonised to avoid the adoption of different requirements in different Member States and to ensure the proper functioning of the internal market while, at the same time, ensuring a high level of environmental protection and public safety. (2) This Regulation is a separate regulation for the purposes of the Community type-approval procedure provided for by Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (3). Therefore, Annexes IV, VI and XI to that Directive should be amended accordingly. (3) Following the request of the European Parliament, a new regulatory approach has been applied to EC vehicle legislation. This Regulation should therefore lay down only fundamental provisions on requirements for the type-approval of hydrogen systems and components, whereas the technical specifications should be laid down by implementing measures adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4). (4) In particular, the Commission should be empowered to establish the requirements and test procedures relating to new forms of hydrogen storage or usage, additional hydrogen components and the propulsion system. The Commission should also be empowered to establish specific procedures, tests and requirements with regard to the impact protection of hydrogen-powered vehicles and integrated system safety requirements. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (5) In the transport sector, one of the main aims should be a greater proportion of more environmentally friendly vehicles. Additional efforts should be undertaken in order to place more of those vehicles on the market. The introduction of vehicles with alternative fuels can significantly improve the quality of urban air and consequently also the state of public health. (6) Hydrogen is considered as a clean way of powering vehicles for the future, on the way towards a pollution-free economy based on the reuse of raw materials and on renewable energy resources, as vehicles propelled with hydrogen emit neither carbon-based pollutants nor greenhouse gases. Since hydrogen is an energy vector and not an energy source, the climate-policy value of hydrogen power depends on the source from which the hydrogen is obtained. Care should therefore be taken that hydrogen fuel is produced in a sustainable manner, as far as possible from renewable energy resources, so that the overall environmental balance of introducing hydrogen as a fuel for motor vehicles is positive. (7) The CARS 21 High Level Group stated in its final report that \u2018efforts with a view to increasing international harmonisation of motor vehicle regulations should be maintained where appropriate, with a view to involve the key vehicle markets and to extend harmonisation to areas not yet covered, notably both in the framework of the 1958 and the 1998 Agreements of the UNECE\u2019. In line with this recommendation, the Commission should continue to support the development of internationally harmonised requirements for motor vehicles under the auspices of UNECE. In particular, if a Global Technical Regulation (GTR) on hydrogen and fuel cell vehicles is adopted, the Commission should consider the possibility of adapting the requirements laid down in this Regulation to those established in the GTR. (8) Hydrogen mixtures could be used as a transition fuel towards the use of pure hydrogen, to facilitate the introduction of hydrogen-powered vehicles in Member States where the natural gas infrastructure is good. The Commission should therefore develop requirements for the use of mixtures of hydrogen and natural gas/biomethane, especially a mixing ratio of hydrogen and gas which takes account of technical feasibility and environmental benefits. (9) Defining the type-approval framework for hydrogen-powered vehicles would contribute to the confidence in the new technology of potential users and the public at large. (10) Therefore, it is necessary to create an adequate framework in order to accelerate the placing on the market of vehicles with innovative propulsion technologies and vehicles which use alternative fuels with a low environmental impact. (11) The majority of manufacturers are making important investments in the development of hydrogen technology and have already started to place such vehicles on the market. In the future, it is likely that the share of hydrogen-powered vehicles in the total fleet will increase. Therefore, the specification of common requirements concerning the safety of hydrogen-powered vehicles is necessary. As manufacturers might follow different approaches to the development of hydrogen-powered vehicles, it is necessary to establish safety requirements in a technology-neutral manner. (12) It is necessary to establish those safety requirements for the hydrogen systems and their components which are necessary in order to obtain type-approval. (13) For type-approval of hydrogen-powered vehicles, it is necessary to establish requirements for the installation of hydrogen systems and their components in the vehicle. (14) Owing to the characteristics of the fuel, hydrogen-powered vehicles may require a specific treatment from rescue services. It is therefore necessary to lay down requirements for the clear and rapid identification of such vehicles, allowing the rescue services to be informed of the fuel stored on board the vehicle. Whilst the means of identification should be fit for that purpose it should, as far as possible, avoid being of a nature that is likely to give rise to concern among the public. (15) It is also important to set out the obligations of manufacturers concerning the adoption of appropriate measures to prevent misfuelling of hydrogen-powered vehicles. (16) Hydrogen-powered vehicles are unlikely to be successful on the market unless adequate filling-station infrastructure is made available in Europe. The Commission should therefore look into suitable measures to support the establishment of a Europe-wide filling-station network for hydrogen-powered vehicles. (17) Innovative small vehicles, designated under EC type-approval legislation as L category vehicles, are considered as early users of hydrogen as a fuel. Introducing hydrogen for these vehicles requires less effort, as the technical challenge and level of investment required is not as high as in the case of M and N category vehicles, as defined in Annex II to Directive 2007/46/EC. The Commission should, no later than 1 January 2010, evaluate the possibility of regulating the type-approval of hydrogen L category vehicles. (18) Since the objective of this Regulation, namely the achievement of the internal market through the introduction of common technical requirements concerning motor vehicles using hydrogen, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes requirements for the type-approval of motor vehicles with regard to hydrogen propulsion and for the type-approval of hydrogen components and hydrogen systems. This Regulation also establishes requirements for the installation of such components and systems. Article 2 Scope This Regulation shall apply to: 1. hydrogen-powered vehicles of categories M and N, as defined in Section A of Annex II to Directive 2007/46/EC, including impact protection and the electric safety of such vehicles; 2. hydrogen components designed for motor vehicles of categories M and N, as listed in Annex I; 3. hydrogen systems designed for motor vehicles of categories M and N, including new forms of hydrogen storage or usage. Article 3 Definitions 1. For the purposes of this Regulation, the following definitions shall apply: (a) \u2018hydrogen-powered vehicle\u2019 means any motor vehicle that uses hydrogen as fuel to propel the vehicle; (b) \u2018propulsion system\u2019 means the internal combustion engine or fuel cell system used to propel the vehicle; (c) \u2018hydrogen component\u2019 means the hydrogen container and all other parts of the hydrogen-powered vehicle that are in direct contact with hydrogen or which form part of a hydrogen system; (d) \u2018hydrogen system\u2019 means an assembly of hydrogen components and connecting parts fitted on hydrogen-powered vehicles, excluding the propulsion systems or auxiliary power units; (e) \u2018maximum allowable working pressure\u2019 (MAWP) means the maximum pressure to which a component is designed to be subjected to and which is the basis for determining the strength of the component under consideration; (f) \u2018nominal working pressure\u2019 (NWP) means, as regards containers, the settled pressure at a uniform temperature of 288K (15 \u00b0C) for a full container, or as regards other components, the pressure level at which a component typically operates; (g) \u2018inner tank\u2019 means the part of the hydrogen container designed to use liquid hydrogen that contains the cryogenic hydrogen. 2. For the purposes of paragraph 1(d), \u2018hydrogen systems\u2019 shall include, inter alia, the following: (a) usage monitoring and control systems; (b) vehicle interface systems; (c) excess flow systems; (d) overpressure protection systems; (e) heat exchanger failure detection systems. Article 4 Obligations of manufacturers 1. Manufacturers shall demonstrate that all new hydrogen-powered vehicles sold, registered or put into service within the Community and all hydrogen components or hydrogen systems sold or put into service within the Community are type-approved in accordance with this Regulation and its implementing measures. 2. For the purposes of vehicle type-approval, manufacturers shall equip hydrogen-powered vehicles with hydrogen components and systems that comply with the requirements of this Regulation and its implementing measures and are installed in accordance with this Regulation and its implementing measures. 3. For the purposes of the type-approval of components and systems, manufacturers shall ensure that hydrogen components and systems comply with the requirements of this Regulation and its implementing measures. 4. Manufacturers shall provide the approval authorities with appropriate information concerning the vehicle specifications and test conditions. 5. Manufacturers shall provide information for the purposes of inspection of hydrogen components and systems during the service life of the vehicle. Article 5 General requirements for hydrogen components and systems Manufacturers shall ensure that: (a) hydrogen components and systems function in a correct and safe way and reliably withstand electrical, mechanical, thermal and chemical operating conditions without leaking or visibly deforming; (b) hydrogen systems are protected against over-pressurisation; (c) the materials used for those parts of the hydrogen components and systems which are to be in direct contact with hydrogen are compatible with hydrogen; (d) hydrogen components and systems reliably withstand expected temperatures and pressures during their expected lifetime; (e) hydrogen components and systems reliably withstand the range of operating temperatures laid down in the implementing measures; (f) hydrogen components are marked in accordance with the implementing measures; (g) hydrogen components with directional flow have the flow direction clearly indicated; (h) hydrogen components and systems are designed in such a way that they can be installed in accordance with the requirements of Annex VI. Article 6 Requirements for hydrogen containers designed to use liquid hydrogen Hydrogen containers designed to use liquid hydrogen shall be tested in accordance with the test procedures set out in Annex II. Article 7 Requirements for hydrogen components, other than containers, designed to use liquid hydrogen 1. Hydrogen components, other than containers, designed to use liquid hydrogen shall be tested in accordance with the test procedures set out in Annex III with regard to their type. 2. Pressure relief devices shall be designed so as to ensure that the pressure in the inner tank or in any other hydrogen component does not exceed a permissible value. The values shall be set in proportion to the maximum allowable working pressure (MAWP) of the hydrogen system. A safety system for heat exchangers shall be provided for the detection of their failure. Article 8 Requirements for hydrogen containers designed to use compressed (gaseous) hydrogen 1. Hydrogen containers designed to use compressed (gaseous) hydrogen shall be classified in accordance with point 1 of Annex IV. 2. The containers referred to in paragraph 1 shall be tested in accordance with the test procedures set out in Annex IV with regard to their type. 3. A detailed description of all principal properties of the material and tolerances used in the design of the container shall be provided, including the results of tests to which the material has been subjected. Article 9 Requirements for hydrogen components, other than containers, designed to use compressed (gaseous) hydrogen Hydrogen components, other than containers, designed to use compressed (gaseous) hydrogen shall be tested in accordance with the test procedures set out in Annex V with regard to their type. Article 10 General requirements for the installation of hydrogen components and systems Hydrogen components and systems shall be installed in accordance with the requirements of Annex VI. Article 11 Timetable for application 1. With effect from 24 February 2011, national authorities shall refuse to grant: (a) EC type-approval or national type-approval in respect of new types of vehicle on grounds relating to hydrogen propulsion, where such vehicle does not comply with the requirements of this Regulation or of its implementing measures; and (b) EC type-approval in respect of new types of hydrogen component or system, where such component or system does not comply with the requirements of this Regulation or of its implementing measures. 2. With effect from 24 February 2012, national authorities shall: (a) on grounds relating to hydrogen propulsion, consider certificates of conformity for new vehicles to be no longer valid for the purposes of Article 26 of Directive 2007/46/EC, and prohibit the registration, sale and entry into service of such vehicles, where such vehicles do not comply with the requirements of this Regulation or of its implementing measures; and (b) prohibit the sale and entry into service of new hydrogen components or systems, where such components or systems do not comply with the requirements of this Regulation or of its implementing measures. 3. Without prejudice to paragraphs 1 and 2, and subject to the entry into force of implementing measures adopted pursuant to Article 12(1), if a manufacturer so requests, national authorities shall not: (a) on grounds relating to hydrogen propulsion, refuse to grant EC type-approval or national type-approval for new types of vehicle, or EC type-approval for new types of hydrogen component or system, where such vehicle, component or system complies with the requirements of this Regulation and its implementing measures; or (b) prohibit the registration, sale and entry into service of new vehicles or the sale and entry into service of new hydrogen components or systems, where such vehicles, components or systems comply with the requirements of this Regulation and its implementing measures. Article 12 Implementing measures 1. The Commission shall adopt the following implementing measures: (a) administrative provisions for the EC type-approval of vehicles, with regard to hydrogen propulsion, and hydrogen components and systems; (b) rules on the information to be provided by manufacturers for the purposes of the type-approval and inspection referred to in Article 4(4) and (5); (c) detailed rules for the test procedures set out in Annexes II to V; (d) detailed rules concerning the requirements for the installation of hydrogen components and systems set out in Annex VI; (e) detailed rules concerning the requirements for the safe and reliable functioning of hydrogen components and systems set out in Article 5; (f) detailed rules for the labelling or other means of clear and rapid identification of hydrogen-powered vehicles referred to in point 16 of Annex VI. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2). 2. The Commission may adopt the following implementing measures: (a) specifications for requirements relating to any of the following: \u2014 the use of pure hydrogen or a mixture of hydrogen and natural gas/biomethane, \u2014 new forms of hydrogen storage or usage, \u2014 the impact protection of vehicles with regard to the integrity of hydrogen components and systems, \u2014 integrated system safety requirements, covering at least the detection of leakage and requirements relating to purge gas, \u2014 electrical isolation and electric safety; (b) other measures necessary for the application of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2). Article 13 Committee procedure 1. The Commission shall be assisted by the Technical Committee \u2014 Motor Vehicles (TCMV) established by Article 40(1) of Directive 2007/46/EC. 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 14 Amendments to Directive 2007/46/EC Annexes IV, VI and XI to Directive 2007/46/EC shall be amended in accordance with Annex VII to this Regulation. Article 15 Penalties for non-compliance 1. Member States shall lay down the provisions on penalties applicable for infringement by manufacturers of the provisions of this Regulation and its implementing measures and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. By 24 August 2010, Member States shall notify those provisions to the Commission, and shall notify it without delay of any subsequent amendment affecting them. 2. The types of infringement which are subject to a penalty shall include at least the following: (a) making false declarations during an approval procedure or a procedure leading to a recall; (b) falsifying test results for type-approval or in-use compliance; (c) withholding data or technical specifications which could lead to recall or withdrawal of type-approval; (d) refusal to provide access to information; (e) use of defeat devices. Article 16 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 24 February 2011, with the exception of Article 11(3) and Article 12, which shall apply from the date of entry into force of this Regulation, and Article 11(2), which shall apply from the date set out therein. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 14 January 2009. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President A. VONDRA (1) Opinion delivered on 9 July 2008. (2) Opinion of the European Parliament of 3 September 2008 (not yet published in the Official Journal) and Council Decision of 16 December 2008. (3) OJ L 263, 9.10.2007, p. 1. (4) OJ L 184, 17.7.1999, p. 23. ANNEX I List of hydrogen components to be type-approved Where fitted to a hydrogen-powered vehicle, the following hydrogen components must be type-approved: (a) components designed to use liquid hydrogen: 1. container; 2. automatic shut-off valve; 3. check valve or non-return valve (if used as a safety device); 4. flexible fuel line (if upstream of first automatic shut-off valve or other safety devices); 5. heat exchanger; 6. manual or automatic valve; 7. pressure regulator; 8. pressure relief valve; 9. pressure, temperature and flow sensors (if used as a safety device); 10. refuelling connection or receptacle; 11. hydrogen leakage detection sensors; (b) components designed to use compressed (gaseous) hydrogen with a nominal working pressure of over 3,0 MPa: 1. container; 2. automatic shut-off valve; 3. container assembly; 4. fittings; 5. flexible fuel line; 6. heat exchanger; 7. hydrogen filter; 8. manual or automatic valve; 9. non-return valve; 10. pressure regulator; 11. pressure relief device; 12. pressure relief valve; 13. refuelling connection or receptacle; 14. removable storage system connector; 15. pressure, temperature, hydrogen and flow sensors (if used as a safety device); 16. hydrogen leakage detection sensors. ANNEX II Applicable test procedures for hydrogen containers designed to use liquid hydrogen Type of test Burst test Bonfire test Maximum filling level test Pressure test Leak test The test procedures to be applied for the type-approval of hydrogen containers designed to use liquid hydrogen must include: (a) Burst test: the purpose of the test is to provide evidence that the hydrogen container does not fail before a specified level of high pressure, the burst pressure (safety factor multiplied by the MAWP) is exceeded. In order to obtain type-approval, the value of the real burst pressure during the test must exceed the required minimum burst pressure. (b) Bonfire test: the purpose of the test is to provide evidence that the container with its fire protection system does not burst when tested under specified fire conditions. (c) Maximum filling level test: the purpose of the test is to provide evidence that the system, which prevents overfilling of the container, works adequately and that the level of hydrogen during the filling procedure never causes the opening of the pressure relief devices. (d) Pressure test: the purpose of the test is to provide evidence that the hydrogen container can withstand a specified level of high pressure. In order to prove this, the container is pressurised to a given value for a specified time. After the test the container must not show any signs of visible permanent deformation or visible leaks. (e) Leak test: the purpose of the test is to provide evidence that the hydrogen container does not show evidence of leakage under specified conditions. In order to prove this, the container is pressurised to its nominal working pressure. It must not show any evidence of leakage detected through cracks, pores or other similar defects. ANNEX III Applicable test procedures for hydrogen components, other than containers, designed to use liquid hydrogen TYPE OF TEST HYDROGEN COMPONENT Pressure test External leakage test Endurance test Operational test Corrosion resistance test Resistance to dry-heat test Ozone ageing test Temperature cycle test Pressure cycle test Hydrogen compatibility test Seat leakage test Pressure relief devices Valves Heat exchangers Refuelling connections or receptacles Pressure regulators Sensors Flexible fuel lines Subject to specific requirements in relation to any of the hydrogen components, the test procedures to be applied for the type-approval of hydrogen components, other than containers, designed to use liquid hydrogen must include: (a) Pressure test: the purpose of the test is to provide evidence that the hydrogen components can withstand a level of pressure which is higher than the working pressure of the component. The hydrogen components must not show any visible evidence of leak, deformation, rupture or cracks when the pressure is increased to a certain level. (b) External leakage test: the purpose of the test is to provide evidence that the hydrogen components are free from external leakage. The hydrogen components must not show evidence of porosity. (c) Endurance test: the purpose of the test is to provide evidence that the hydrogen components are capable of continuous reliable operation. The test consists of carrying out a specific number of test cycles for the hydrogen component under specified temperature and pressure conditions. A test cycle means the normal operation (i.e. one opening and one closing) of the hydrogen component. (d) Operational test: the purpose of the test is to provide evidence that the hydrogen components are capable of operating reliably. (e) Corrosion resistance test: the purpose of the test is to provide evidence that the hydrogen components are capable of resisting corrosion. In order to prove this, the hydrogen components are submitted to contact with specified chemicals. (f) Resistance to dry-heat test: the purpose of the test is to provide evidence that the non-metallic hydrogen components are capable of resisting high temperature. In order to prove this, the components are exposed to air at the maximum operating temperature. (g) Ozone ageing test: the purpose of the test is to provide evidence that the non-metallic hydrogen components are capable of resisting ageing due to ozone. In order to prove this, the components are exposed to air with high ozone concentration. (h) Temperature cycle test: the purpose of the test is to provide evidence that the hydrogen components are capable of resisting high variations of temperature. In order to prove this, the hydrogen components are submitted to a temperature cycle of specified duration from the minimum operating temperature up to the maximum operating temperature. (i) Pressure cycle test: the purpose of the test is to provide evidence that the hydrogen components are capable of resisting high variations of pressure. In order to prove this, the hydrogen components are submitted to a pressure change from atmospheric pressure to the maximum allowable working pressure (MAWP) and then back to atmospheric pressure within a short period of time. (j) Hydrogen compatibility test: the purpose of the test is to provide evidence that metallic hydrogen components (i.e. cylinders and valves) are not susceptible to hydrogen embrittlement. In hydrogen components that are subjected to frequent load cycles, conditions that can lead to local fatigue and the initiation and propagation of fatigue cracks in the structure must be avoided. (k) Seat leakage test: the purpose of the test is to provide evidence that hydrogen components are free from leakage while installed in the hydrogen system. ANNEX IV Applicable test procedures for hydrogen containers designed to use compressed (gaseous) hydrogen Type of test Applicable to container type 1 2 3 4 Burst test Ambient temperature pressure cycle test LBB performance test Bonfire test Penetration test Chemical exposure test Composite flaw tolerance test Accelerated stress rupture test Extreme temperature pressure cycle test Impact damage test Leak test Permeation test Boss torque test Hydrogen gas cycle test 1. Classification of hydrogen containers designed to use compressed (gaseous) hydrogen: Type 1 Seamless metallic container Type 2 Hoop wrapped container with a seamless metallic liner Type 3 Fully wrapped container with a seamless or welded metallic liner Type 4 Fully wrapped container with a non-metallic liner. 2. The test procedures to be applied for the type-approval of hydrogen containers designed to use compressed (gaseous) hydrogen must include: (a) Burst test: the purpose of the test is to provide the value of the pressure at which the container bursts. In order to prove this, the container is pressurised to a given value, which must be higher than the nominal working pressure of the container. The burst pressure of the container must exceed a specified pressure. The burst pressure of the container must be recorded and be kept by the manufacturer throughout the service life of the container. (b) Ambient temperature pressure cycle test: the purpose of the test is to provide evidence that the hydrogen container is capable of resisting high variations of pressure. In order to prove this, pressure cycles are carried out on the container until a failure occurs or until a specified number of cycles is reached by increasing and decreasing the pressure to a specified value. The containers must not fail before reaching a specified number of cycles. The number of cycles to failure, along with the location and description of the failure, must be documented. The manufacturer must keep the results throughout the service life of the container. (c) Leak before break (LBB) performance test: the purpose of the test is to provide evidence that the hydrogen container fails by leakage before rupture. In order to prove this, pressure cycles are carried out on the container by increasing and decreasing the pressure to a specified value. The containers tested must either fail by leakage or exceed a specified number of test cycles without failure. The number of cycles to failure, along with the location and description of the failure, must be recorded. (d) Bonfire test: the purpose of the test is to provide evidence that the container with its fire protection system does not burst when tested under specified fire conditions. The container, pressurised to working pressure, must only vent through the pressure relief device and must not rupture. (e) Penetration test: the purpose of the test is to provide evidence that the container does not rupture when penetrated by a bullet. In order to prove this, the complete container with its protective coating is pressurised and penetrated by a bullet. The container must not rupture. (f) Chemical exposure test: the purpose of the test is to provide evidence that the container can withstand exposure to specified chemical substances. In order to prove this, the container is exposed to various chemical solutions. The pressure of the container is increased to a given value and a burst test as referred to under point (a) is carried out. The container must achieve a specified burst pressure, which must be recorded. (g) Composite flaw tolerance test: the purpose of the test is to provide evidence that the hydrogen container is capable of resisting exposure to high pressure. In order to prove this, flaws of specified geometry are cut into the container sidewall and a specified number of pressure cycles carried out. The container must not leak or rupture within a number of cycles, but may fail by leakage during the remaining test cycles. The number of cycles to failure, along with the location and description of the failure, must be recorded. (h) Accelerated stress rupture test: the purpose of the test is to provide evidence that the hydrogen container is capable of resisting exposure to high pressure and high temperatures at the limit of the allowable operating range for an extended period of time. In order to prove this, the container is exposed for a specified time to specified pressure and temperature conditions, and subsequently undergoes a burst test as referred to under point (a). The container must achieve a specified burst pressure. (i) Extreme temperature pressure cycle test: the purpose of the test is to provide evidence that the hydrogen container can withstand variations of pressure under different temperature conditions. In order to prove this, the container, free of any protective coating, is hydrostatically cycle tested by being subjected to extreme ambient conditions, and subsequently undergoes a burst test and a leak test as referred to under points (a) and (k). When cycle tested, the containers must not show evidence of rupture, leakage or fibre unravelling. The containers must not burst at a specified pressure. (j) Impact damage test: the purpose of the test is to provide evidence that the hydrogen container remains operational after being submitted to the specified mechanical impacts. In order to prove this, the container is subjected to a drop test, and a specified number of pressure cycles are carried out. The container must not leak or rupture within a specified number of cycles, but may fail by leakage during the remaining test cycles. (k) Leak test: the purpose of the test is to provide evidence that the hydrogen container does not show evidence of leakage under the specified conditions. In order to prove this, the container is pressurised to its nominal working pressure. It must not show any evidence of leakage detected through cracks, pores or similar defects. (l) Permeation test: the purpose of the test is to provide evidence that the hydrogen container does not permeate more than a specified rate. In order to prove this, the container is pressurised with hydrogen gas to nominal working pressure and then monitored for permeation in a closed chamber for a specified time under specified temperature conditions. (m) Boss torque test: the purpose of the test is to provide evidence that the hydrogen container is capable of resisting the specified torque. In order to prove this, a torque is applied to the container from different directions. Then a burst test and a leak test as referred to under points (a) and (k) are carried out. The container must meet the burst and leak test requirements. The applied torque, leakage and burst pressure must be recorded. (n) Hydrogen gas cycle test: the purpose of the test is to provide evidence that the hydrogen container is capable of resisting high variations of pressure when hydrogen gas is used. In order to prove this, the container is subjected to a number of pressure cycles with the use of hydrogen gas and a leak test as referred to under point (k). Deteriorations, such as fatigue cracking or electrostatic discharge of the container, are inspected. The container must meet leak test requirements. The container must be free of any deterioration, such as fatigue cracking or electrostatic discharge. ANNEX V Applicable test procedures for hydrogen components, other than containers, designed to use compressed (gaseous) hydrogen TYPE OF TEST HYDROGEN COMPONENT Material tests Corrosion resistance test Endurance test Pressure cycle test Internal leakage test External leakage test Pressure relief devices Automatic valves Manual valves Non-return valves Pressure relief valves Heat exchangers Refuelling connections or receptacles Pressure regulators Sensors for hydrogen systems Flexible fuel lines Fittings Hydrogen filters Removable storage system connectors Subject to specific requirements for any of the hydrogen components, the test procedures to be applied for the type-approval of hydrogen components, other than containers, designed to use compressed (gaseous) hydrogen must include: 1. Material tests: 1.1. Hydrogen compatibility test set out in point (j) of Annex III. 1.2. Ageing test: the purpose of the test is to check whether the non-metallic material used in a hydrogen component can withstand ageing. No visible cracking of the test samples is allowed. 1.3. Ozone compatibility test: the purpose of the test is to check whether the elastomer material of a hydrogen component is compatible with ozone exposure. No visible cracking of the test samples is allowed. 2. Corrosion resistance test set out in point (e) of Annex III. 3. Endurance test set out in point (c) of Annex III. 4. Pressure cycle test set out in point (i) of Annex III. The hydrogen components must not show visible signs of deformation or extrusion and must fulfil the requirements of the internal and external leakage tests. 5. Internal leakage test: the purpose of the test is to provide evidence that the specified hydrogen components are free from internal leakage. In order to prove this, the hydrogen components are pressurised under different temperature conditions and observed for leakage. The hydrogen components must stay bubble free and must not leak internally at a higher rate than a specified number. 6. External leakage test set out in point (b) of Annex III. ANNEX VI Requirements for the installation of hydrogen components and systems 1. The hydrogen system must be installed in such a way that it is protected against damage. It must be isolated from heat sources in the vehicle. 2. The hydrogen container may only be removed for replacement with another hydrogen container, for the purpose of refuelling or for maintenance. In the case of an internal combustion engine, the container must not be installed in the engine compartment of the vehicle. It must be adequately protected against all kinds of corrosion. 3. Measures must be taken to prevent misfuelling of the vehicle and hydrogen leakage during refilling and to make sure that the removal of a removable hydrogen storage system is done safely. 4. The refuelling connection or receptacle must be secured against maladjustment and protected from dirt and water. The refuelling connection or receptacle must be integrated with a non-return valve or a valve with the same function. If the refuelling connection is not mounted directly on the container, the refuelling line must be secured by a non-return valve or a valve with the same function which is mounted directly on or within the container. 5. The hydrogen container must be mounted and fixed so that the specified accelerations can be absorbed without damage to the safety related parts when the hydrogen containers are full. 6. The hydrogen fuel supply lines must be secured with an automatic shut-off valve mounted directly on or within the container. The valve shall close if a malfunction of the hydrogen system so requires or any other event that results in the leakage of hydrogen occurs. When the propulsion system is switched off, the fuel supply from the container to the propulsion system must be switched off and remain closed until the system is required to operate. 7. In the event of an accident, the automatic shut-off valve mounted directly on or within the container shall interrupt the flow of gas from the container. 8. Hydrogen components, including any protective materials that form part of such components, must not project beyond the outline of the vehicle or protective structure. This does not apply to a hydrogen component which is adequately protected and no part of which is located outside this protective structure. 9. The hydrogen system must be installed in such a way that it is protected against damage so far as is reasonably practicable, such as damage due to moving vehicle components, impacts, grit, the loading or unloading of the vehicle or the shifting of loads. 10. Hydrogen components must not be located near the exhaust of an internal combustion engine or other heat source, unless such components are adequately shielded against heat. 11. The ventilating or heating system for the passenger compartment and places where leakage or accumulation of hydrogen is possible must be designed so that hydrogen is not drawn into the vehicle. 12. In the event of an accident, it must be ensured so far as is reasonably practicable that the pressure relief device and the associated venting system remain capable of functioning. The venting system of the pressure relief device must be adequately protected against dirt and water. 13. The passenger compartment of the vehicle must be separated from the hydrogen system in order to avoid accumulation of hydrogen. It must be ensured that any fuel leaking from the container or its accessories does not escape to the passenger compartment of the vehicle. 14. Hydrogen components that could leak hydrogen within the passenger or luggage compartment or other non-ventilated compartment must be enclosed by a gas-tight housing or by an equivalent solution as specified in the implementing measures. 15. Electrically operated devices containing hydrogen must be insulated in such a manner that no current passes through hydrogen containing parts in order to prevent electric sparks in the case of a fracture. Metallic components of the hydrogen system must have electrical continuity with the vehicle\u2019s earth. 16. Labels or other means of identification must be used to indicate to rescue services that the vehicle is powered by hydrogen and that liquid or compressed (gaseous) hydrogen is used. ANNEX VII Amendments to Directive 2007/46/EC Directive 2007/46/EC is hereby amended as follows: 1. In Part I of Annex IV, the following row shall be added to the table: Item Subject Regulatory act reference Official Journal reference Applicability M1 M2 M3 N1 N2 N3 O1 O2 O3 O4 \u201862 Hydrogen system Regulation (EC) No 79/2009 L 35, 4.2.2009, p. 32 X X X X X X\u2019 2. In the Appendix to Part I of Annex IV, the following row shall be added to the table: Subject Regulatory act reference Official Journal reference M1 \u201862 Hydrogen system Regulation (EC) No 79/2009 L 35, 4.2.2009, p. 32 X\u2019 3. In the Appendix to Annex VI, the following row shall be added to the table: Subject Regulatory act reference (1) As amended by Applicable to versions \u201862. Hydrogen system Regulation (EC) No 79/2009\u2019 4. In Appendix 1 to Annex XI, the following row shall be added to the table: Item Subject Regulatory act reference M1 \u2264 2 500 (1) kg M1 > 2 500 (1) kg M2 M3 \u201862 Hydrogen system Regulation (EC) No 79/2009 Q G + Q G + Q G + Q\u2019 5. In Appendix 2 to Annex XI, the following row shall be added to the table: Item Subject Regulatory act reference M1 M2 M3 N1 N2 N3 O1 O2 O3 O4 \u201862 Hydrogen system Regulation (EC) No 79/2009 A A A A A A\u2019 6. In Appendix 3 to Annex XI, the following row shall be added to the table: Item Subject Regulatory act reference M1 \u201862 Hydrogen system Regulation (EC) No 79/2009 X\u2019 7. In Appendix 4 to Annex XI, the following row shall be added to the table: Item Subject Regulatory act reference M2 M3 N1 N2 N3 O1 O2 O3 O4 \u201862 Hydrogen system Regulation (EC) No 79/2009 Q Q Q Q Q\u2019 8. In Appendix 5 to Annex XI, the following row shall be added to the table: Item Subject Regulatory act reference Mobile crane of category N3 \u201862 Hydrogen system Regulation (EC) No 79/2009 X\u2019", "summary": "Hydrogen-powered vehicles \u2014 type-approval rules Hydrogen-powered vehicles \u2014 type-approval rules SUMMARY OF: Regulation (EC) No 79/2009 on type-approval of hydrogen-powered motor vehicles SUMMARY WHAT DOES THIS REGULATION DO? It establishes manufacturing requirements for hydrogen-powered vehicles used to carry passengers and goods and for their components and systems. KEY POINTS Manufacturers must demonstrate that all new hydrogen-powered vehicles sold, registered or put into service in the EU and their component parts comply with the legislation provide approval authorities with appropriate information on the vehicles\u2019 specifications and test conditions provide the necessary information for when hydrogen components and systems are inspected during vehicle servicing. Manufacturers must ensure hydrogen components and systems can withstand electrical, mechanical, thermal and chemical operating conditions without leaking or becoming deformed are protected against overly high pressures can reliably withstand expected temperatures and pressures during their lifetime are designed in such a way that they can be installed and protected against damage. The legislation contains specific test procedures for different types of hydrogen containers and components. The European Commission has the authority to adopt implementing measures such as the detailed rules for the various tests and the information manufacturers must supply. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 24 February 2011. ACT Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14 January 2009 on type-approval of hydrogen-powered motor vehicles, and amending Directive 2007/46/EC (OJ L 35, 4.2.2009, pp. 32\u201346) RELATED ACT Commission Regulation (EU) No 406/2010 of 26 April 2010 implementing Regulation (EC) No 79/2009 of the European Parliament and of the Council on type-approval of hydrogen-powered motor vehicles (OJ L 122, 18.5.2010, pp. 1\u2013107). Successive amendments to Commission Regulation (EU) No 406/2010 have been incorporated into the original text. This consolidated version is of documentary value only. Commission Regulation (EU) No 630/2012 of 12 July 2012 amending Regulation (EC) No 692/2008, as regards type-approval requirements for motor vehicles fuelled by hydrogen and mixtures of hydrogen and natural gas with respect to emissions, and the inclusion of specific information regarding vehicles fitted with an electric power train in the information document for the purpose of EC type-approval (OJ L 182, 13.7.2012, pp. 14\u201326) last update 21.03.2016"}
{"article": "14.8.2009 EN Official Journal of the European Union L 211/36 REGULATION (EC) No 715/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) The internal market in natural gas, which has been progressively implemented since 1999, aims to deliver real choice for all consumers in the Community, be they citizens or businesses, new business opportunities and more cross-border trade, so as to achieve efficiency gains, competitive prices and higher standards of service, and to contribute to security of supply and sustainability. (2) Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas (4) and Regulation (EC) No 1775/2005 of the European Parliament and of the Council of 28 September 2005 on conditions for access to the natural gas transmission networks (5) have made significant contributions towards the creation of such an internal market in natural gas. (3) Experience gained in the implementation and monitoring of a first set of Guidelines for Good Practice, adopted by the European Gas Regulatory Forum (the Madrid Forum) in 2002, demonstrates that in order to ensure the full implementation of the rules set out in those guidelines in all Member States, and in order to provide a minimum guarantee of equal market access conditions in practice, it is necessary to provide for them to become legally enforceable. (4) A second set of common rules entitled \u2018the Second Guidelines for Good Practice\u2019 was adopted at the meeting of the Madrid Forum on 24 and 25 September 2003 and the purpose of this Regulation is to lay down, on the basis of those guidelines, basic principles and rules regarding network access and third party access services, congestion management, transparency, balancing and the trading of capacity rights. (5) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas (6) provides for the possibility of a combined transmission and distribution system operator. The rules set out in this Regulation do not therefore require modification of the organisation of national transmission and distribution systems that are consistent with the relevant provisions of that Directive. (6) High-pressure pipelines linking up local distributors to the gas network which are not primarily used in the context of local distribution are included in the scope of this Regulation. (7) It is necessary to specify the criteria according to which tariffs for access to the network are determined, in order to ensure that they fully comply with the principle of non-discrimination and the needs of a well-functioning internal market and take fully into account the need for system integrity and reflect the actual costs incurred, insofar as such costs correspond to those of an efficient and structurally comparable network operator and are transparent, whilst including appropriate return on investments, and, where appropriate, taking account of the benchmarking of tariffs by the regulatory authorities. (8) In calculating tariffs for access to networks, it is important to take account of the actual costs incurred, insofar as such costs correspond to those of an efficient and structurally comparable network operator, and are transparent, as well as of the need to provide appropriate return on investments and incentives to construct new infrastructure, including special regulatory treatment for new investments as provided for in Directive 2009/73/EC. In that respect, and in particular if effective pipeline-to-pipeline competition exists, the benchmarking of tariffs by the regulatory authorities will be a relevant consideration. (9) The use of market-based arrangements, such as auctions, to determine tariffs has to be compatible with the provisions laid down in Directive 2009/73/EC. (10) A common minimum set of third-party access services is necessary to provide a common minimum standard of access in practice throughout the Community, to ensure that third party access services are sufficiently compatible and to allow the benefits accruing from a well-functioning internal market in natural gas to be exploited. (11) At present, there are obstacles to the sale of gas on equal terms, without discrimination or disadvantage in the Community. In particular, non-discriminatory network access and an equally effective level of regulatory supervision do not yet exist in each Member State, and isolated markets persist. (12) A sufficient level of cross-border gas interconnection capacity should be achieved and market integration fostered in order to complete the internal market in natural gas. (13) The Communication of the Commission of 10 January 2007 entitled \u2018An Energy Policy for Europe\u2019 highlighted the importance of completing the internal market in natural gas and creating a level playing field for all natural gas undertakings in the Community. The Communications of the Commission of 10 January 2007 entitled \u2018Prospects for the internal gas and electricity market\u2019 and \u2018Inquiry pursuant to Article 17 of Regulation (EC) No 1/2003 into the European gas and electricity sectors (Final Report)\u2019 demonstrated that the present rules and measures neither provide the necessary framework nor provide for the creation of interconnection capacities to achieve the objective of a well-functioning, efficient and open internal market. (14) In addition to thoroughly implementing the existing regulatory framework, the regulatory framework for the internal market in natural gas set out in Regulation (EC) No 1775/2005 should be adapted in line with those communications. (15) In particular, increased cooperation and coordination among transmission system operators is required to create network codes for providing and managing effective and transparent access to the transmission networks across borders, and to ensure coordinated and sufficiently forward looking planning and sound technical evolution of the transmission system in the Community, including the creation of interconnection capacities, with due regard to the environment. The network codes should be in line with framework guidelines which are non-binding in nature (framework guidelines) and which are developed by the Agency for the Cooperation of Energy Regulators established by Regulation (EC) No 713/2009 of the European Parliament and of the Council of 13 July 2009 establishing an Agency for the Cooperation of Energy Regulators (7) (the Agency). The Agency should have a role in reviewing, based on matters of fact, draft network codes, including their compliance with the framework guidelines, and it should be enabled to recommend them for adoption by the Commission. The Agency should assess proposed amendments to the network codes and it should be enabled to recommend them for adoption by the Commission. Transmission system operators should operate their networks in accordance with those network codes. (16) In order to ensure optimal management of the gas transmission network in the Community a European Network of Transmission System Operators for Gas (the ENTSO for Gas), should be established. The tasks of the ENTSO for Gas should be carried out in compliance with Community competition rules which remain applicable to the decisions of the ENTSO for Gas. The tasks of the ENTSO for Gas should be well-defined and its working method should ensure efficiency, transparency and the representative nature of the ENTSO for Gas. The network codes prepared by the ENTSO for Gas are not intended to replace the necessary national network codes for non cross-border issues. Given that more effective progress may be achieved through an approach at regional level, transmission system operators should set up regional structures within the overall cooperation structure, whilst ensuring that results at regional level are compatible with network codes and non-binding ten-year network development plans at Community level. Cooperation within such regional structures presupposes effective unbundling of network activities from production and supply activities. In the absence of such unbundling, regional cooperation between transmission system operators gives rise to a risk of anti-competitive conduct. Member States should promote cooperation and monitor the effectiveness of the network operations at regional level. Cooperation at regional level should be compatible with progress towards a competitive and efficient internal market in gas. (17) All market participants have an interest in the work expected of the ENTSO for Gas. An effective consultation process is therefore essential and existing structures set up to facilitate and streamline the consultation process, such as the European Association for the Streamlining of Energy Exchange, national regulators or the Agency should play an important role. (18) In order to ensure greater transparency regarding the development of the gas transmission network in the Community, the ENTSO for Gas should draw up, publish and regularly update a non-binding Community-wide ten-year network development plan (Community-wide network development plan). Viable gas transmission networks and necessary regional interconnections, relevant from a commercial or security of supply point of view, should be included in that network development plan. (19) To enhance competition through liquid wholesale markets for gas, it is vital that gas can be traded independently of its location in the system. The only way to do this is to give network users the freedom to book entry and exit capacity independently, thereby creating gas transport through zones instead of along contractual paths. The preference for entry-exit systems to facilitate the development of competition was already expressed by most stakeholders at the 6th Madrid Forum on 30 and 31 October 2002. Tariffs should not be dependent on the transport route. The tariff set for one or more entry points should therefore not be related to the tariff set for one or more exit points, and vice versa. (20) References to harmonised transport contracts in the context of non-discriminatory access to the network of transmission system operators do not mean that the terms and conditions of the transport contracts of a particular system operator in a Member State must be the same as those of another transmission system operator in that Member State or in another Member State, unless minimum requirements are set which must be met by all transport contracts. (21) There is substantial contractual congestion in the gas networks. The congestion-management and capacity-allocation principles for new or newly negotiated contracts are therefore based on the freeing-up of unused capacity by enabling network users to sublet or resell their contracted capacities and the obligation of transmission system operators to offer unused capacity to the market, at least on a day-ahead and interruptible basis. Given the large proportion of existing contracts and the need to create a true level playing field between users of new and existing capacity, those principles should be applied to all contracted capacity, including existing contracts. (22) Although physical congestion of networks is, at present, rarely a problem in the Community, it may become one in the future. It is important, therefore, to provide the basic principle for the allocation of congested capacity in such circumstances. (23) Market monitoring undertaken over recent years by the national regulatory authorities and by the Commission has shown that current transparency requirements and rules on access to infrastructure are not sufficient to secure a genuine, well-functioning, open and efficient internal market in gas. (24) Equal access to information on the physical status and efficiency of the system is necessary to enable all market participants to assess the overall demand and supply situation and to identify the reasons for movements in the wholesale price. This includes more precise information on supply and demand, network capacity, flows and maintenance, balancing and availability and usage of storage. The importance of that information for the functioning of the market requires alleviating existing limitations to publication for confidentiality reasons. (25) Confidentiality requirements for commercially sensitive information are, however, particularly relevant where data of a commercially strategic nature for the company are concerned, where there is only one single user for a storage facility, or where data are concerned regarding exit points within a system or subsystem that is not connected to another transmission or distribution system but to a single industrial final customer, where the publication of such data would reveal confidential information as to the production process of that customer. (26) To enhance trust in the market, its participants need to be sure that those engaging in abusive behaviour can be subjected to effective, proportionate and dissuasive penalties. The competent authorities should be given the competence to investigate effectively allegations of market abuse. To that end, it is necessary that competent authorities have access to data that provides information on operational decisions made by supply undertakings. In the gas market, all those decisions are communicated to the system operators in the form of capacity reservations, nominations and realised flows. System operators should keep information in relation thereto available to and easily accessible by the competent authorities for a fixed period of time. The competent authorities should, furthermore, regularly monitor the compliance of the transmission system operators with the rules. (27) Access to gas storage facilities and liquefied natural gas (LNG) facilities is insufficient in some Member States, and therefore the implementation of the existing rules needs to be improved. Monitoring by the European Regulators' Group for Electricity and Gas concluded that the voluntary guidelines for good third-party access practice for storage system operators, agreed by all stakeholders at the Madrid Forum, are being insufficiently applied and therefore need to be made binding. (28) Non-discriminatory and transparent balancing systems for gas, operated by transmission system operators, are important mechanisms, particularly for new market entrants which may have more difficulty balancing their overall sales portfolio than companies already established within a relevant market. It is therefore necessary to lay down rules to ensure that transmission system operators operate such mechanisms in a manner compatible with non-discriminatory, transparent and effective access conditions to the network. (29) The trading of primary capacity rights is an important part of developing a competitive market and creating liquidity. This Regulation should therefore lay down basic rules relating to such trading. (30) National regulatory authorities should ensure compliance with the rules contained in this Regulation and the Guidelines adopted pursuant thereto. (31) In the Guidelines annexed to this Regulation, specific detailed implementing rules are defined on the basis of the Second Guidelines for Good Practice. Where appropriate, those rules will evolve over time, taking into account the differences of national gas systems. (32) When proposing to amend the Guidelines annexed to this Regulation, the Commission should ensure prior consultation of all relevant parties concerned with the Guidelines, represented by the professional organisations, and of the Member States within the Madrid Forum. (33) The Member States and the competent national authorities should be required to provide relevant information to the Commission. Such information should be treated confidentially by the Commission. (34) This Regulation and the Guidelines adopted in accordance with it are without prejudice to the application of the Community rules on competition. (35) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8). (36) In particular, the Commission should be empowered to establish or adopt the Guidelines necessary for providing the minimum degree of harmonisation required to achieve the aims of this Regulation. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (37) Since the objective of this Regulation, namely the setting of fair rules for access conditions to natural gas transmission networks, storage and LNG facilities cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (38) Given the scope of the amendments that are being made herein to Regulation (EC) No 1775/2005, it is desirable, for reasons of clarity and rationalisation, that the provisions in question should be recast by bringing them all together in a single text in a new Regulation, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope This Regulation aims at: (a) setting non-discriminatory rules for access conditions to natural gas transmission systems taking into account the special characteristics of national and regional markets with a view to ensuring the proper functioning of the internal market in gas; (b) setting non-discriminatory rules for access conditions to LNG facilities and storage facilities taking into account the special characteristics of national and regional markets; and (c) facilitating the emergence of a well-functioning and transparent wholesale market with a high level of security of supply in gas and providing mechanisms to harmonise the network access rules for cross-border exchanges in gas. The objectives referred to in the first subparagraph shall include the setting of harmonised principles for tariffs, or the methodologies underlying their calculation, for access to the network, but not to storage facilities, the establishment of third-party access services and harmonised principles for capacity-allocation and congestion-management, the determination of transparency requirements, balancing rules and imbalance charges, and the facilitation of capacity trading. This Regulation, with the exception of Article 19(4), shall apply only to storage facilities falling under Article 33(3) or (4) of Directive 2009/73/EC. The Member States may establish an entity or body set up in compliance with Directive 2009/73/EC for the purpose of carrying out one or more functions typically attributed to the transmission system operator, which shall be subject to the requirements of this Regulation. That entity or body shall be subject to certification in accordance with Article 3 of this Regulation and shall be subject to designation in accordance with Article 10 of Directive 2009/73/EC. Article 2 Definitions 1. For the purpose of this Regulation, the following definitions apply: 1) \u2018transmission\u2019 means the transport of natural gas through a network, which mainly contains high-pressure pipelines, other than an upstream pipeline network and other than the part of high-pressure pipelines primarily used in the context of local distribution of natural gas, with a view to its delivery to customers, but not including supply; 2) \u2018transport contract\u2019 means a contract which the transmission system operator has concluded with a network user with a view to carrying out transmission; 3) \u2018capacity\u2019 means the maximum flow, expressed in normal cubic meters per time unit or in energy unit per time unit, to which the network user is entitled in accordance with the provisions of the transport contract; 4) \u2018unused capacity\u2019 means firm capacity which a network user has acquired under a transport contract but which that user has not nominated by the deadline specified in the contract; 5) \u2018congestion management\u2019 means management of the capacity portfolio of the transmission system operator with a view to optimal and maximum use of the technical capacity and the timely detection of future congestion and saturation points; 6) \u2018secondary market\u2019 means the market of the capacity traded otherwise than on the primary market; 7) \u2018nomination\u2019 means the prior reporting by the network user to the transmission system operator of the actual flow that the network user wishes to inject into or withdraw from the system; 8) \u2018re-nomination\u2019 means the subsequent reporting of a corrected nomination; 9) \u2018system integrity\u2019 means any situation in respect of a transmission network including necessary transmission facilities in which the pressure and the quality of the natural gas remain within the minimum and maximum limits laid down by the transmission system operator, so that the transmission of natural gas is guaranteed from a technical standpoint; 10) \u2018balancing period\u2019 means the period within which the off-take of an amount of natural gas, expressed in units of energy, must be offset by every network user by means of the injection of the same amount of natural gas into the transmission network in accordance with the transport contract or the network code; 11) \u2018network user\u2019 means a customer or a potential customer of a transmission system operator, and transmission system operators themselves in so far as it is necessary for them to carry out their functions in relation to transmission; 12) \u2018interruptible services\u2019 means services offered by the transmission system operator in relation to interruptible capacity; 13) \u2018interruptible capacity\u2019 means gas transmission capacity that may be interrupted by the transmission system operator in accordance with the conditions stipulated in the transport contract; 14) \u2018long-term services\u2019 means services offered by the transmission system operator with a duration of one year or more; 15) \u2018short-term services\u2019 means services offered by the transmission system operator with a duration of less than one year; 16) \u2018firm capacity\u2019 means gas transmission capacity contractually guaranteed as uninterruptible by the transmission system operator; 17) \u2018firm services\u2019 mean services offered by the transmission system operator in relation to firm capacity; 18) \u2018technical capacity\u2019 means the maximum firm capacity that the transmission system operator can offer to the network users, taking account of system integrity and the operational requirements of the transmission network; 19) \u2018contracted capacity\u2019 means capacity that the transmission system operator has allocated to a network user by means of a transport contract; 20) \u2018available capacity\u2019 means the part of the technical capacity that is not allocated and is still available to the system at that moment; 21) \u2018contractual congestion\u2019 means a situation where the level of firm capacity demand exceeds the technical capacity; 22) \u2018primary market\u2019 means the market of the capacity traded directly by the transmission system operator; 23) \u2018physical congestion\u2019 means a situation where the level of demand for actual deliveries exceeds the technical capacity at some point in time; 24) \u2018LNG facility capacity\u2019 means capacity at an LNG terminal for the liquefaction of natural gas or the importation, offloading, ancillary services, temporary storage and re-gasification of LNG; 25) \u2018space\u2019 means the volume of gas which a user of a storage facility is entitled to use for the storage of gas; 26) \u2018deliverability\u2019 means the rate at which the storage facility user is entitled to withdraw gas from the storage facility; 27) \u2018injectability\u2019 means the rate at which the storage facility user is entitled to inject gas into the storage facility; 28) \u2018storage capacity\u2019 means any combination of space, injectability and deliverability. 2. Without prejudice to the definitions in paragraph 1 of this Article, the definitions contained in Article 2 of Directive 2009/73/EC, which are relevant for the application of this Regulation, also apply, with the exception of the definition of transmission in point 3 of that Article. The definitions in points 3 to 23 of paragraph 1 of this Article in relation to transmission apply by analogy in relation to storage and LNG facilities. Article 3 Certification of transmission system operators 1. The Commission shall examine any notification of a decision on the certification of a transmission system operator as laid down in Article 10(6) of Directive 2009/73/EC as soon as it is received. Within two months of the day of receipt of such notification, the Commission shall deliver its opinion to the relevant national regulatory authority in regard to its compatibility with Article 10(2) or Article 11, and Article 9 of Directive 2009/73/EC. When preparing the opinion referred to in the first subparagraph, the Commission may request the Agency to provide its opinion on the national regulatory authority's decision. In such a case, the two-month period referred to in the first subparagraph shall be extended by two further months. In the absence of an opinion by the Commission within the periods referred to in the first and second subparagraphs, the Commission shall be deemed not to raise objections against the regulatory authority's decision. 2. Within two months of receiving an opinion of the Commission, the national regulatory authority shall adopt its final decision regarding the certification of the transmission system operator, taking the utmost account of that opinion. The regulatory authority's decision and the Commission's opinion shall be published together. 3. At any time during the procedure regulatory authorities and/or the Commission may request from a transmission system operator and/or an undertaking performing any of the functions of production or supply any information relevant to the fulfilment of their tasks under this Article. 4. Regulatory authorities and the Commission shall preserve the confidentiality of commercially sensitive information. 5. The Commission may adopt Guidelines setting out the details of the procedure to be followed for the application of paragraphs 1 and 2 of this Article. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). 6. Where the Commission has received notification of the certification of a transmission system operator under Article 9(10) of Directive 2009/73/EC, the Commission shall take a decision relating to certification. The regulatory authority shall comply with the Commission decision. Article 4 European network of transmission system operators for gas All transmission system operators shall cooperate at Community level through the ENTSO for Gas, in order to promote the completion and functioning of the internal market in natural gas and cross-border trade and to ensure the optimal management, coordinated operation and sound technical evolution of the natural gas transmission network. Article 5 Establishment of the ENTSO for Gas 1. By 3 March 2011, the transmission system operators for gas shall submit to the Commission and to the Agency the draft statutes, a list of members and draft rules of procedure, including the rules of procedures on the consultation of other stakeholders, of the ENTSO for Gas to be established. 2. Within two months of the day of the receipt, the Agency, after formally consulting the organisations representing all stakeholders, in particular the system users including customers, shall provide an opinion to the Commission on the draft statutes, list of members and draft rules of procedure. 3. The Commission shall deliver an opinion on the draft statutes, list of members and draft rules of procedures taking into account the opinion of the Agency provided for in paragraph 2 and within three months of the day of the receipt of the opinion of the Agency. 4. Within three months of the day of receipt of the Commission's opinion, the transmission system operators shall establish the ENTSO for Gas, adopt and publish its statutes and rules of procedure. Article 6 Establishment of network codes 1. The Commission shall, after consulting the Agency, the ENTSO for Gas and the other relevant stakeholders establish an annual priority list identifying the areas set out in Article 8(6) to be included in the development of network codes. 2. The Commission shall request the Agency to submit to it within a reasonable period of time not exceeding six months a non-binding framework guideline (framework guideline) setting out clear and objective principles, in accordance with Article 8(7), for the development of network codes relating to the areas identified in the priority list. Each framework guideline shall contribute to non-discrimination, effective competition and the efficient functioning of the market. Upon a reasoned request from the Agency, the Commission may extend that period. 3. The Agency shall formally consult the ENTSO for Gas and the other relevant stakeholders in regard to the framework guideline, during a period of no less than two months, in an open and transparent manner. 4. If the Commission considers that the framework guideline does not contribute to non-discrimination, effective competition and the efficient functioning of the market, it may request the Agency to review the framework guideline within a reasonable period of time and re-submit it to the Commission. 5. If the Agency fails to submit or re-submit a framework guideline within the period set by the Commission under paragraphs 2 or 4, the Commission shall elaborate the framework guideline in question. 6. The Commission shall request the ENTSO for Gas to submit a network code which is in line with the relevant framework guideline, to the Agency within a reasonable period of time not exceeding 12 months. 7. Within a period of three months after the day of receipt of a network code, during which the Agency may formally consult the relevant stakeholders, the Agency shall provide a reasoned opinion to the ENTSO for Gas on the network code. 8. The ENTSO for Gas may amend the network code in the light of the opinion of the Agency and re-submit it to the Agency. 9. Once the Agency is satisfied that the network code is in line with the relevant framework guideline, the Agency shall submit the network code to the Commission and may recommend that it be adopted within a reasonable time period. The Commission shall provide reasons in the event that it does not adopt that network code. 10. Where the ENTSO for Gas has failed to develop a network code within the period of time set by the Commission under paragraph 6, the Commission may request the Agency to prepare a draft network code on the basis of the relevant framework guideline. The Agency may launch a further consultation in the course of preparing a draft network code under this paragraph. The Agency shall submit a draft network code prepared under this paragraph to the Commission and may recommend that it be adopted. 11. The Commission may adopt, on its own initiative where the ENTSO for Gas has failed to develop a network code, or the Agency has failed to develop a draft network code as referred to in paragraph 10 of this Article, or upon recommendation of the Agency under paragraph 9 of this Article, one or more network codes in the areas listed in Article 8(6). Where the Commission proposes to adopt a network code on its own initiative, the Commission shall consult the Agency, the ENTSO for Gas and all relevant stakeholders in regard to the draft network code during a period of no less than two months. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). 12. This Article shall be without prejudice to the Commission's right to adopt and amend the Guidelines as laid down in Article 23. Article 7 Amendments of network codes 1. Draft amendments to any network code adopted under Article 6 may be proposed to the Agency by persons who are likely to have an interest in that network code, including the ENTSO for Gas, transmission system operators, network users and consumers. The Agency may also propose amendments of its own initiative. 2. The Agency shall consult all stakeholders in accordance with Article 10 of Regulation (EC) No 713/2009. Following this process, the Agency may make reasoned proposals for amendments to the Commission, explaining how such proposals are consistent with the objectives of the network codes set out in Article 6(2) of this Regulation. 3. The Commission may adopt, taking account of the Agency's proposals, amendments to any network code adopted under Article 6. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). 4. Consideration of proposed amendments under the procedure set out in Article 28(2) shall be limited to consideration of the aspects related to the proposed amendment. Those proposed amendments are without prejudice to other amendments which the Commission may propose. Article 8 Tasks of the ENTSO for Gas 1. The ENTSO for Gas shall elaborate network codes in the areas referred to in paragraph 6 of this Article upon a request addressed to it by the Commission in accordance with Article 6(6). 2. The ENTSO for Gas may elaborate network codes in the areas set out in paragraph 6 with a view to achieving the objectives set out in Article 4 where those network codes do not relate to areas covered by a request addressed to it by the Commission. Those network codes shall be submitted to the Agency for an opinion. That opinion shall be duly taken into account by the ENTSO for Gas. 3. The ENTSO for Gas shall adopt: (a) common network operation tools to ensure coordination of network operation in normal and emergency conditions, including a common incidents classification scale, and research plans; (b) a non-binding Community-wide ten-year network development plan (Community-wide network development plan), including a European supply adequacy outlook, every two years; (c) recommendations relating to the coordination of technical cooperation between Community and third-country transmission system operators; (d) an annual work programme; (e) an annual report; (f) annual summer and winter supply outlooks. 4. The European supply adequacy outlook referred to in point (b) of paragraph 3 shall cover the overall adequacy of the gas system to supply current and projected demands for gas for the next five-year period as well as for the period between five and 10 years from the date of that outlook. The European supply adequacy outlook shall build on national supply outlooks prepared by each individual transmission system operator. 5. The annual work programme referred to in point (d) of paragraph 3 shall contain a list and description of the network codes to be prepared, a plan on coordination of operation of the network, and research and development activities, to be realised in that year, and an indicative calendar. 6. The network codes referred to in paragraphs 1 and 2 shall cover the following areas, taking into account, if appropriate, regional special characteristics: (a) network security and reliability rules; (b) network connection rules; (c) third-party access rules; (d) data exchange and settlement rules; (e) interoperability rules; (f) operational procedures in an emergency; (g) capacity-allocation and congestion-management rules; (h) rules for trading related to technical and operational provision of network access services and system balancing; (i) transparency rules; (j) balancing rules including network-related rules on nominations procedure, rules for imbalance charges and rules for operational balancing between transmission system operators' systems; (k) rules regarding harmonised transmission tariff structures; and (l) energy efficiency regarding gas networks. 7. The network codes shall be developed for cross-border network issues and market integration issues and shall be without prejudice to the Member States' right to establish national network codes which do not affect cross-border trade. 8. The ENTSO for Gas shall monitor and analyse the implementation of the network codes and the Guidelines adopted by the Commission in accordance with Article 6(11), and their effect on the harmonisation of applicable rules aimed at facilitating market integration. The ENTSO for Gas shall report its findings to the Agency and shall include the results of the analysis in the annual report referred to in point (e) of paragraph 3 of this Article. 9. The ENTSO for Gas shall make available all information required by the Agency to fulfil its tasks under Article 9(1). 10. The ENTSO for Gas shall adopt and publish a Community-wide network development plan referred to in point (b) of paragraph 3 every two years. The Community-wide network development plan shall include the modelling of the integrated network, scenario development, a European supply adequacy outlook and an assessment of the resilience of the system. The Community-wide network development plan shall, in particular: (a) build on national investment plans, taking into account regional investment plans as referred to in Article 12(1), and, if appropriate, Community aspects of network planning, including the guidelines for trans-European energy networks in accordance with Decision No 1364/2006/EC of the European Parliament and of the Council (9); (b) regarding cross-border interconnections, also build on the reasonable needs of different network users and integrate long-term commitments from investors referred to in Articles 14 and 22 of Directive 2009/73/EC; and (c) identify investment gaps, notably with respect to cross-border capacities. In regard to point (c) of the second subparagraph, a review of barriers to the increase of cross-border capacity of the network arising from different approval procedures or practices may be annexed to the Community-wide network development plan. 11. The Agency shall review national ten-year network development plans to assess their consistency with the Community-wide network development plan. If the Agency identifies inconsistencies between a national ten-year network development plan and the Community-wide network development plan, it shall recommend amending the national ten-year network development plan or the Community-wide network development plan as appropriate. If such national ten-year network development plan is elaborated in accordance with Article 22 of Directive 2009/73/EC, the Agency shall recommend that the competent national regulatory authority amend the national ten-year network development plan in accordance with Article 22(7) of that Directive and inform the Commission thereof. 12. Upon request of the Commission, the ENTSO for Gas shall give its views to the Commission on the adoption of the Guidelines as laid down in Article 23. Article 9 Monitoring by the Agency 1. The Agency shall monitor the execution of the tasks referred to in Article 8(1), (2) and (3) of the ENTSO for Gas and report to the Commission. The Agency shall monitor the implementation by the ENTSO for Gas of network codes elaborated under Article 8(2) and network codes which have been developed in accordance with Article 6(1) to (10) but which have not been adopted by the Commission under Article 6(11). Where the ENTSO for Gas has failed to implement such network codes, the Agency shall request the ENTSO for Gas to provide a duly reasoned explanation as to why it has failed to do so. The Agency shall inform the Commission of that explanation and provide its opinion thereon. The Agency shall monitor and analyse the implementation of the network codes and the Guidelines adopted by the Commission as laid down in Article 6(11), and their effect on the harmonisation of applicable rules aimed at facilitating market integration as well as on non-discrimination, effective competition and the efficient functioning of the market, and report to the Commission. 2. The ENTSO for Gas shall submit the draft Community-wide network development plan, the draft annual work programme, including the information regarding the consultation process and the other documents referred to in Article 8(3), to the Agency for its opinion. Within two months from the day of receipt, the Agency shall provide a duly reasoned opinion as well as recommendations to the ENTSO for Gas and to the Commission where it considers that the draft annual work programme or the draft Community-wide network development plan submitted by the ENTSO for Gas do not contribute to non-discrimination, effective competition, the efficient functioning of the market or a sufficient level of cross-border interconnection open to third-party access. Article 10 Consultations 1. While preparing the network codes, the draft Community-wide network development plan and the annual work programme referred to in Article 8(1), (2) and (3), the ENTSO for Gas shall conduct an extensive consultation process, at an early stage and in an open and transparent manner, involving all relevant market participants, and, in particular, the organisations representing all stakeholders, in accordance with the rules of procedure referred to in Article 5(1). That consultation shall also involve national regulatory authorities and other national authorities, supply and production undertakings, network users including customers, distribution system operators, including relevant industry associations, technical bodies and stakeholder platforms. It shall aim at identifying the views and proposals of all relevant parties during the decision-making process. 2. All documents and minutes of meetings related to the consultations referred to in paragraph 1 shall be made public. 3. Before adopting the annual work programme and the network codes referred to in Article 8(1), (2) and (3), the ENTSO for Gas shall indicate how the observations received during the consultation have been taken into consideration. It shall provide reasons where observations have not been taken into account. Article 11 Costs The costs related with the activities of the ENTSO for Gas referred to in Articles 4 to 12 shall be borne by the transmission system operators and shall be taken into account in the calculation of tariffs. Regulatory authorities shall approve those costs only if they are reasonable and proportionate. Article 12 Regional cooperation of transmission system operators 1. Transmission system operators shall establish regional cooperation within the ENTSO for Gas to contribute to the tasks referred to in Article 8(1), (2) and (3). In particular, they shall publish a regional investment plan every two years, and may take investment decisions based on that regional investment plan. 2. Transmission system operators shall promote operational arrangements in order to ensure the optimum management of the network and shall promote the development of energy exchanges, the coordinated allocation of cross-border capacity through non-discriminatory market-based solutions, paying due attention to the specific merits of implicit auctions for short-term allocations and the integration of balancing mechanisms. 3. For the purposes of achieving the goals set in paragraphs 1 and 2, the geographical area covered by each regional cooperation structure may be defined by the Commission, taking into account existing regional cooperation structures. Each Member State shall be allowed to promote cooperation in more than one geographical area. The measure referred to in the first sentence, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). For that purpose, the Commission shall consult the Agency and the ENTSO for Gas. Article 13 Tariffs for access to networks 1. Tariffs, or the methodologies used to calculate them, applied by the transmission system operators and approved by the regulatory authorities pursuant to Article 41(6) of Directive 2009/73/EC, as well as tariffs published pursuant to Article 32(1) of that Directive, shall be transparent, take into account the need for system integrity and its improvement and reflect the actual costs incurred, insofar as such costs correspond to those of an efficient and structurally comparable network operator and are transparent, whilst including an appropriate return on investments, and, where appropriate, taking account of the benchmarking of tariffs by the regulatory authorities. Tariffs, or the methodologies used to calculate them, shall be applied in a non-discriminatory manner. Member States may decide that tariffs may also be determined through market-based arrangements, such as auctions, provided that such arrangements and the revenues arising therefrom are approved by the regulatory authority. Tariffs, or the methodologies used to calculate them, shall facilitate efficient gas trade and competition, while at the same time avoiding cross-subsidies between network users and providing incentives for investment and maintaining or creating interoperability for transmission networks. Tariffs for network users shall be non-discriminatory and set separately for every entry point into or exit point out of the transmission system. Cost-allocation mechanisms and rate setting methodology regarding entry points and exit points shall be approved by the national regulatory authorities. By 3 September 2011, the Member States shall ensure that, after a transitional period, network charges shall not be calculated on the basis of contract paths. 2. Tariffs for network access shall neither restrict market liquidity nor distort trade across borders of different transmission systems. Where differences in tariff structures or balancing mechanisms would hamper trade across transmission systems, and notwithstanding Article 41(6) of Directive 2009/73/EC, transmission system operators shall, in close cooperation with the relevant national authorities, actively pursue convergence of tariff structures and charging principles, including in relation to balancing. Article 14 Third-party access services concerning transmission system operators 1. Transmission system operators shall: (a) ensure that they offer services on a non-discriminatory basis to all network users; (b) provide both firm and interruptible third-party access services. The price of interruptible capacity shall reflect the probability of interruption; (c) offer to network users both long and short-term services. In regard to point (a) of the first subparagraph, where a transmission system operator offers the same service to different customers, it shall do so under equivalent contractual terms and conditions, either using harmonised transport contracts or a common network code approved by the competent authority in accordance with the procedure laid down in Article 41 of Directive 2009/73/EC. 2. Transport contracts signed with non-standard start dates or with a shorter duration than a standard annual transport contract shall not result in arbitrarily higher or lower tariffs that do not reflect the market value of the service, in accordance with the principles laid down in Article 13(1). 3. Where appropriate, third-party access services may be granted subject to appropriate guarantees from network users with respect to the creditworthiness of such users. Such guarantees shall not constitute undue market-entry barriers and shall be non-discriminatory, transparent and proportionate. Article 15 Third-party access services concerning storage and LNG facilities 1. LNG and storage system operators shall: (a) offer services on a non-discriminatory basis to all network users that accommodate market demand; in particular, where an LNG or storage system operator offers the same service to different customers, it shall do so under equivalent contractual terms and conditions; (b) offer services that are compatible with the use of the interconnected gas transport systems and facilitate access through cooperation with the transmission system operator; and (c) make relevant information public, in particular data on the use and availability of services, in a time-frame compatible with the LNG or storage facility users' reasonable commercial needs, subject to the monitoring of such publication by the national regulatory authority. 2. Each storage system operator shall: (a) provide both firm and interruptible third-party access services; the price of interruptible capacity shall reflect the probability of interruption; (b) offer to storage facility users both long and short-term services; and (c) offer to storage facility users both bundled and unbundled services of storage space, injectability and deliverability. 3. LNG and storage facility contracts shall not result in arbitrarily higher tariffs in cases in which they are signed: (a) outside a natural gas year with non-standard start dates; or (b) with a shorter duration than a standard LNG and storage facility contract on an annual basis. 4. Where appropriate, third-party access services may be granted subject to appropriate guarantees from network users with respect to the creditworthiness of such users. Such guarantees shall not constitute undue market-entry barriers and shall be non-discriminatory, transparent and proportionate. 5. Contractual limits on the required minimum size of LNG facility capacity and storage capacity shall be justified on the basis of technical constrains and shall permit smaller storage users to gain access to storage services. Article 16 Principles of capacity-allocation mechanisms and congestion-management procedures concerning transmission system operators 1. The maximum capacity at all relevant points referred to in Article 18(3) shall be made available to market participants, taking into account system integrity and efficient network operation. 2. The transmission system operator shall implement and publish non-discriminatory and transparent capacity-allocation mechanisms, which shall: (a) provide appropriate economic signals for the efficient and maximum use of technical capacity, facilitate investment in new infrastructure and facilitate cross-border exchanges in natural gas; (b) be compatible with the market mechanisms including spot markets and trading hubs, while being flexible and capable of adapting to evolving market circumstances; and (c) be compatible with the network access systems of the Member States. 3. The transmission system operator shall implement and publish non-discriminatory and transparent congestion-management procedures which facilitate cross-border exchanges in natural gas on a non-discriminatory basis and which shall be based on the following principles: (a) in the event of contractual congestion, the transmission system operator shall offer unused capacity on the primary market at least on a day-ahead and interruptible basis; and (b) network users who wish to re-sell or sublet their unused contracted capacity on the secondary market shall be entitled to do so. In regard to point (b) of the first subparagraph, a Member State may require notification or information of the transmission system operator by network users. 4. In the event that physical congestion exists, non-discriminatory, transparent capacity-allocation mechanisms shall be applied by the transmission system operator or, as appropriate, by the regulatory authorities. 5. Transmission system operators shall regularly assess market demand for new investment. When planning new investments, transmission system operators shall assess market demand and take into account security of supply. Article 17 Principles of capacity-allocation mechanisms and congestion-management procedures concerning storage and LNG facilities 1. The maximum storage and LNG facility capacity shall be made available to market participants, taking into account system integrity and operation. 2. LNG and storage system operators shall implement and publish non-discriminatory and transparent capacity-allocation mechanisms which shall: (a) provide appropriate economic signals for the efficient and maximum use of capacity and facilitate investment in new infrastructure; (b) be compatible with the market mechanism including spot markets and trading hubs, while being flexible and capable of adapting to evolving market circumstances; and (c) be compatible with the connected network access systems. 3. LNG and storage facility contracts shall include measures to prevent capacity-hoarding, by taking into account the following principles, which shall apply in cases of contractual congestion: (a) the system operator must offer unused LNG facility and storage capacity on the primary market without delay; for storage facilities this must be at least on a day-ahead and interruptible basis; (b) LNG and storage facility users who wish to re-sell their contracted capacity on the secondary market must be entitled to do so. Article 18 Transparency requirements concerning transmission system operators 1. The transmission system operator shall make public detailed information regarding the services it offers and the relevant conditions applied, together with the technical information necessary for network users to gain effective network access. 2. In order to ensure transparent, objective and non-discriminatory tariffs and facilitate efficient utilisation of the gas network, transmission system operators or relevant national authorities shall publish reasonably and sufficiently detailed information on tariff derivation, methodology and structure. 3. For the services provided, each transmission system operator shall make public information on technical, contracted and available capacities on a numerical basis for all relevant points including entry and exit points on a regular and rolling basis and in a user-friendly and standardised manner. 4. The relevant points of a transmission system on which the information is to be made public shall be approved by the competent authorities after consultation with network users. 5. The transmission system operator shall always disclose the information required by this Regulation in a meaningful, quantifiably clear and easily accessible manner and on a non-discriminatory basis. 6. The transmission system operator shall make public ex-ante and ex-post supply and demand information, based on nominations, forecasts and realised flows in and out of the system. The national regulatory authority shall ensure that all such information is made public. The level of detail of the information that is made public shall reflect the information available to the transmission system operator. The transmission system operator shall make public measures taken as well as costs incurred and revenue generated to balance the system. The market participants concerned shall provide the transmission system operator with the data referred to in this Article. Article 19 Transparency requirements concerning storage facilities and LNG facilities 1. LNG and storage system operators shall make public detailed information regarding the services it offers and the relevant conditions applied, together with the technical information necessary for LNG and storage facility users to gain effective access to the LNG and storage facilities. 2. For the services provided, LNG and storage system operators shall make public information on contracted and available storage and LNG facility capacities on a numerical basis on a regular and rolling basis and in a user-friendly standardised manner. 3. LNG and storage system operators shall always disclose the information required by this Regulation in a meaningful, quantifiably clear and easily accessible way and on a non-discriminatory basis. 4. LNG and storage system operators shall make public the amount of gas in each storage or LNG facility, or group of storage facilities if that corresponds to the way in which the access is offered to system users, inflows and outflows, and the available storage and LNG facility capacities, including for those facilities exempted from third-party access. That information shall also be communicated to the transmission system operator, which shall make it public on an aggregated level per system or subsystem defined by the relevant points. The information shall be updated at least daily. In cases in which a storage system user is the only user of a storage facility, the storage system user may submit to the national regulatory authority a reasoned request for confidential treatment of the data referred to in the first subparagraph. Where the national regulatory authority comes to the conclusion that such a request is justified, taking into account, in particular, the need to balance the interest of legitimate protection of business secrets, the disclosure of which would negatively affect the overall commercial strategy of the storage user, with the objective of creating a competitive internal gas market, it may allow the storage system operator not to make public the data referred to in the first subparagraph, for a duration of up to one year. The second subparagraph shall apply without prejudice to the obligations of communication to and publication by the transmission system operator referred to in the first subparagraph, unless the aggregated data are identical to the individual storage system data for which the national regulatory authority has approved non-publication. 5. In order to ensure transparent, objective and non-discriminatory tariffs and facilitate efficient utilisation of the infrastructures, the LNG and storage facility operators or relevant regulatory authorities shall make public sufficiently detailed information on tariff derivation, the methodologies and the structure of tariffs for infrastructure under regulated third-party access. Article 20 Record keeping by system operators Transmission system operators, storage system operators and LNG system operators shall keep at the disposal of the national authorities, including the national regulatory authority, the national competition authority and the Commission, all information referred to in Articles 18 and 19, and in Part 3 of Annex I for a period of five years. Article 21 Balancing rules and imbalance charges 1. Balancing rules shall be designed in a fair, non-discriminatory and transparent manner and shall be based on objective criteria. Balancing rules shall reflect genuine system needs taking into account the resources available to the transmission system operator. Balancing rules shall be market-based. 2. In order to enable network users to take timely corrective action, the transmission system operator shall provide sufficient, well-timed and reliable on-line based information on the balancing status of network users. The information provided shall reflect the level of information available to the transmission system operator and the settlement period for which imbalance charges are calculated. No charge shall be made for the provision of information under this paragraph. 3. Imbalance charges shall be cost-reflective to the extent possible, whilst providing appropriate incentives on network users to balance their input and off-take of gas. They shall avoid cross-subsidisation between network users and shall not hamper the entry of new market entrants. Any calculation methodology for imbalance charges as well as the final tariffs shall be made public by the competent authorities or the transmission system operator, as appropriate. 4. Member States shall ensure that transmission system operators endeavour to harmonise balancing regimes and streamline structures and levels of balancing charges in order to facilitate gas trade. Article 22 Trading of capacity rights Each transmission, storage and LNG system operator shall take reasonable steps to allow capacity rights to be freely tradable and to facilitate such trade in a transparent and non-discriminatory manner. Every such operator shall develop harmonised transport, LNG facility and storage contracts and procedures on the primary market to facilitate secondary trade of capacity and shall recognise the transfer of primary capacity rights where notified by system users. The harmonised transport, LNG facility and storage contracts and procedures shall be notified to the regulatory authorities. Article 23 Guidelines 1. Where appropriate, Guidelines providing the minimum degree of harmonisation required to achieve the aims of this Regulation shall specify: (a) details of third-party access services, including the character, duration and other requirements of those services, in accordance with Articles 14 and 15; (b) details of the principles underlying capacity-allocation mechanisms and on the application of congestion-management procedures in the event of contractual congestion, in accordance with Articles 16 and 17; (c) details of the provision of information, definition of the technical information necessary for network users to gain effective access to the system and the definition of all relevant points for transparency requirements, including the information to be published at all relevant points and the time schedule for the publication of that information, in accordance with Articles 18 and 19; (d) details of tariff methodology related to cross-border trade of natural gas, in accordance with Article 13; (e) details relating to the areas listed in Article 8(6). For that purpose, the Commission shall consult the Agency and the ENTSO for Gas. 2. Guidelines on the issues listed in points (a), (b) and (c) of paragraph 1 are laid down in Annex I with respect to transmission system operators. The Commission may adopt Guidelines on the issues listed in paragraph 1 of this Article and amend the Guidelines referred to in points (a), (b) and (c) thereof. Those measures, designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). 3. The application and amendment of Guidelines adopted pursuant to this Regulation shall reflect differences between national gas systems, and shall, therefore, not require uniform detailed terms and conditions of third-party access at Community level. They may, however, set minimum requirements to be met to achieve non-discriminatory and transparent network access conditions necessary for an internal market in natural gas, which may then be applied in the light of differences between national gas systems. Article 24 Regulatory authorities When carrying out their responsibilities under this Regulation, the regulatory authorities shall ensure compliance with this Regulation and the Guidelines adopted pursuant to Article 23. Where appropriate, they shall cooperate with each other, with the Commission and the Agency in compliance with Chapter VIII of Directive 2009/73/EC. Article 25 Provision of information Member States and the regulatory authorities shall, on request, provide to the Commission all information necessary for the purposes of Article 23. The Commission shall set a reasonable time limit within which the information is to be provided, taking into account the complexity of the information required and the urgency with which the information is needed. Article 26 Right of Member States to provide for more detailed measures This Regulation shall be without prejudice to the rights of Member States to maintain or introduce measures that contain more detailed provisions than those set out herein or in the Guidelines referred to in Article 23. Article 27 Penalties 1. The Member States shall lay down rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that those provisions are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify the Commission by 1 July 2006 of those rules corresponding to the provisions laid down in Regulation (EC) No 1775/2005 and shall notify the Commission without delay of any subsequent amendment affecting them. They shall notify the Commission of those rules not corresponding to the provisions laid down in Regulation (EC) No 1775/2005 by 3 September 2009 and shall notify the Commission without delay of any subsequent amendment affecting them. 2. Penalties provided for pursuant to paragraph 1 shall not be of a criminal law nature. Article 28 Committee procedure 1. The Commission shall be assisted by the committee set up by Article 51 of Directive 2009/73/EC. 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 29 Commission report The Commission shall monitor the implementation of this Regulation. In its report under Article 52(6) of Directive 2009/73/EC, the Commission shall also report on the experience gained in the application of this Regulation. In particular, the report shall examine to what extent this Regulation has been successful in ensuring non-discriminatory and cost-reflective network access conditions for gas transmission networks in order to contribute to customer choice in a well-functioning internal market and to long-term security of supply. If necessary, the report shall be accompanied by appropriate proposals and/or recommendations. Article 30 Derogations and exemptions This Regulation shall not apply to: (a) natural gas transmission systems situated in Member States for the duration of derogations granted under Article 49 of Directive 2009/73/EC; (b) major new infrastructure, i.e. interconnectors, LNG and storage facilities, and significant increases of capacity in existing infrastructure and modifications of such infrastructure which enable the development of new sources of gas supply referred to in Article 36(1) and (2) of Directive 2009/73/EC which are exempt from the provisions of Articles 9, 14, 32, 33, 34 or Article 41(6), (8) and (10) of that Directive as long as they are exempt from the provisions referred to in this subparagraph, with the exception of Article 19(4) of this Regulation; or (c) natural gas transmission systems which have been granted derogations under Article 48 of Directive 2009/73/EC. As regards point (a) of the first subparagraph, Member States that have been granted derogations under Article 49 of Directive 2009/73/EC may apply to the Commission for a temporary derogation from the application of this Regulation, for a period of up to two years from the date on which the derogation referred to in that point expires. Article 31 Repeal Regulation (EC) No 1775/2005 shall be repealed from 3 March 2011. References made to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 32 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 3 September 2009. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 13 July 2009. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President E. ERLANDSSON (1) OJ C 211, 19.8.2008, p. 23. (2) OJ C 172, 5.7.2008, p. 55. (3) Opinion of the European Parliament of 9 July 2008 (not yet published in the Official Journal), Council Common Position of 9 January 2009 (OJ C 75 E, 31.3.2009, p. 38) and Position of the European Parliament of 22 April 2009 (not yet published in the Official Journal). Council Decision of 25 June 2009. (4) OJ L 176, 15.7.2003, p. 57. (5) OJ L 289, 3.11.2005, p. 1. (6) See page 94 of this Official Journal. (7) See page 1 of this Official Journal. (8) OJ L 184, 17.7.1999, p. 23. (9) OJ L 262, 22.9.2006, p. 1. ANNEX I GUIDELINES ON 1. Third-party access services concerning transmission system operators 1. Transmission system operators shall offer firm and interruptible services down to a minimum period of one day. 2. Harmonised transport contracts and common network codes shall be designed in a manner that facilitates trading and re-utilisation of capacity contracted by network users without hampering capacity release. 3. Transmission system operators shall develop network codes and harmonised contracts following proper consultation with network users. 4. Transmission system operators shall implement standardised nomination and re-nomination procedures. They shall develop information systems and electronic communication means to provide adequate data to network users and to simplify transactions, such as nominations, capacity contracting and transfer of capacity rights between network users. 5. Transmission system operators shall harmonise formalised request procedures and response times according to best industry practice with the aim of minimising response times. They shall provide for online screen-based capacity booking and confirmation systems and nomination and re-nomination procedures no later than 1 July 2006 after consultation with the relevant network users. 6. Transmission system operators shall not separately charge network users for information requests and transactions associated with their transport contracts and which are carried out according to standard rules and procedures. 7. Information requests that require extraordinary or excessive expenses such as feasibility studies may be charged separately, provided the charges can be duly substantiated. 8. Transmission system operators shall cooperate with other transmission system operators in coordinating the maintenance of their respective networks in order to minimise any disruption of transmission services to network users and transmission system operators in other areas and in order to ensure equal benefits with respect to security of supply including in relation to transit. 9. Transmission system operators shall publish at least annually, by a predetermined deadline, all planned maintenance periods that might affect network users' rights from transport contracts and corresponding operational information with adequate advance notice. This shall include publishing on a prompt and non-discriminatory basis any changes to planned maintenance periods and notification of unplanned maintenance, as soon as that information becomes available to the transmission system operator. During maintenance periods, transmission system operators shall publish regularly updated information on the details of and expected duration and effect of the maintenance. 10. Transmission system operators shall maintain and make available to the competent authority upon request a daily log of the actual maintenance and flow disruptions that have occurred. Information shall also be made available on request to those affected by any disruption. 2. Principles of capacity-allocation mechanisms and congestion-management procedures concerning transmission system operators and their application in the event of contractual congestion 2.1. Principles of capacity-allocation mechanisms and congestion-management procedures concerning transmission system operators 1. Capacity-allocation mechanisms and congestion-management procedures shall facilitate the development of competition and liquid trading of capacity and shall be compatible with market mechanisms including spot markets and trading hubs. They shall be flexible and capable of adapting to evolving market circumstances. 2. Those mechanisms and procedures shall take into account the integrity of the system concerned as well as security of supply. 3. Those mechanisms and procedures shall neither hamper the entry of new market participants nor create undue barriers to market entry. They shall not prevent market participants, including new market entrants and companies with a small market share, from competing effectively. 4. Those mechanisms and procedures shall provide appropriate economic signals for efficient and maximum use of technical capacity and facilitate investment in new infrastructure. 5. Network users shall be advised about the type of circumstance that could affect the availability of contracted capacity. Information on interruption should reflect the level of information available to the transmission system operator. 6. Should difficulties in meeting contractual delivery obligations arise due to system integrity reasons, transmission system operators should notify network users and seek a non-discriminatory solution without delay. Transmission system operators shall consult network users regarding procedures prior to their implementation and agree them with the regulatory authority. 2.2. Congestion-management procedures in the event of contractual congestion 1. In the event that contracted capacity goes unused, transmission system operators shall make that capacity available on the primary market on an interruptible basis via contracts of differing duration, as long as that capacity is not offered by the relevant network user on the secondary market at a reasonable price. 2. Revenues from released interruptible capacity shall be split according to rules laid down or approved by the relevant regulatory authority. Those rules shall be compatible with the requirement of an effective and efficient use of the system. 3. A reasonable price for released interruptible capacity may be determined by the relevant regulatory authorities taking into account the specific circumstances prevailing. 4. Where appropriate, transmission system operators shall make reasonable endeavours to offer at least parts of the unused capacity to the market as firm capacity. 3. Definition of the technical information necessary for network users to gain effective access to the system, the definition of all relevant points for transparency requirements and the information to be published at all relevant points and the time schedule according to which that information shall be published 3.1. Definition of the technical information necessary for network users to gain effective access to the system Transmission system operators shall publish at least the following information about their systems and services: (a) a detailed and comprehensive description of the different services offered and their charges; (b) the different types of transport contracts available for those services and, as applicable, the network code and/or the standard conditions outlining the rights and responsibilities of all network users including harmonised transport contracts and other relevant documents; (c) the harmonised procedures applied when using the transmission system, including the definition of key terms; (d) provisions on capacity allocation, congestion management, and anti-hoarding and re-utilisation procedures; (e) the rules applicable to capacity trade on the secondary market as regards the transmission system operator; (f) if applicable, the flexibility and tolerance levels included in transport and other services without separate charge, as well as any flexibility offered in addition thereto and the corresponding charges; (g) a detailed description of the gas system of the transmission system operator indicating all relevant points interconnecting its system with that of other transmission system operators and/or gas infrastructure such as liquefied natural gas (LNG) and infrastructure necessary for providing ancillary services as defined by Article 2 point 14 of Directive 2009/73/EC; (h) information on gas quality and pressure requirements; (i) the rules applicable for connection to the system operated by the transmission system operator; (j) any information, in a timely manner, as regards proposed and/or actual changes to the services or conditions, including the items listed in points (a) to (i). 3.2. Definition of all relevant points for transparency requirements Relevant points shall include at least: (a) all entry points to a network operated by a transmission system operator; (b) the most important exit points and exit zones covering at least 50 % of total exit capacity of the network of a given transmission system operator, including all exit points or exit zones covering more than 2 % of total exit capacity of the network; (c) all points connecting different networks of transmission system operators; (d) all points connecting the network of a transmission system operator with an LNG terminal; (e) all essential points within the network of a given transmission system operator including points connecting to gas hubs. All points are considered essential which, based on experience, are likely to experience physical congestion; (f) all points connecting the network of a given transmission system operator to infrastructure necessary for providing ancillary services as defined by Article 2, point 14 of Directive 2009/73/EC. 3.3. Information to be published at all relevant points and the time schedule according to which that information should be published 1. At all relevant points, transmission system operators shall publish the following information about the capacity situation down to daily periods on the Internet on a regular/rolling basis and in a user-friendly standardised manner: (a) the maximum technical capacity for flows in both directions; (b) the total contracted and interruptible capacity; and (c) the available capacity. 2. For all relevant points, transmission system operators shall publish available capacities for a period of at least 18 months ahead and shall update that information at least every month or more frequently, if new information becomes available. 3. Transmission system operators shall publish daily updates of availability of short-term services (day-ahead and week-ahead) based, inter alia, on nominations, prevailing contractual commitments and regular long-term forecasts of available capacities on an annual basis for up to ten years for all relevant points. 4. Transmission system operators shall publish historical maximum and minimum monthly capacity utilisation rates and annual average flows at all relevant points for the past three years on a rolling basis. 5. Transmission system operators shall keep a daily log of actual aggregated flows for at least three months. 6. Transmission system operators shall keep effective records of all capacity contracts and all other relevant information in relation to calculating and providing access to available capacities, to which relevant national authorities shall have access to fulfil their duties. 7. Transmission system operators shall provide user-friendly instruments for calculating tariffs for the services available and for verifying on-line the capacity available. 8. Where transmission system operators are unable to publish information in accordance with points 1, 3 and 7, they shall consult their relevant national authorities and set up an action plan for implementation as soon as possible, but no later than 31 December 2006. ANNEX II CORRELATION TABLE Regulation (EC) No 1775/2005 This Regulation Article 1 Article 1 Article 2 Article 2 \u2014 Article 3 \u2014 Article 4 \u2014 Article 5 \u2014 Article 6 \u2014 Article 7 \u2014 Article 8 \u2014 Article 9 \u2014 Article 10 \u2014 Article 11 \u2014 Article 12 Article 3 Article 13 Article 4 Article 14 \u2014 Article 15 Article 5 Article 16 \u2014 Article 17 Article 6 Article 18 \u2014 Article 19 \u2014 Article 20 Article 7 Article 21 Article 8 Article 22 Article 9 Article 23 Article 10 Article 24 Article 11 Article 25 Article 12 Article 26 Article 13 Article 27 Article 14 Article 28 Article 15 Article 29 Article 16 Article 30 \u2014 Article 31 Article 17 Article 32 Annex Annex I", "summary": "Natural gas transmission networks Natural gas transmission networks SUMMARY OF: Regulation (EC) No 715/2009 on conditions for access to the natural gas transmission networks WHAT IS THE AIM OF THE REGULATION? It lays down rules for access to: natural gas transmission* networks; gas storage; and liquefied natural gas facilities. These rules aim to counteract barriers to competition in the EU\u2019s market for natural gas and to ensure its smooth operation. KEY POINTS The regulation determines: how tariffs (solely for access to networks) are set; the services to be offered; the allocation of capacity to gas transmission system operators (TSOs)*; transparency requirements (such as rules on publishing how they arrive at their tariffs and their tariff structure); and balancing* rules and imbalance charges on the market. Certification of transmission system operators National regulatory authorities (NRAs) must notify the European Commission of decisions relating to certifying a TSO. The Commission has 2 months to deliver its opinion to an NRA . The authority then adopts the final decision concerning the TSO\u2019s certification. This decision and the Commission\u2019s opinion are published. Creation of the European Network of Transmission System Operators for Gas (ENTSOG) The gas TSOs had to submit to the Commission and to the Agency for the Cooperation of Energy Regulators (ACER) the draft statutes for the ENTSOG, a list of members and draft rules of procedure by 3 March 2011. Tasks of the ENTSOG concerning network codes The Commission must consult ACER and the ENTSOG in order to establish an annual list of the priorities for developing sets of rules (known as network codes). These codes are developed using a non-binding guideline submitted to the Commission by ACER. The codes relate in particular to: capacity allocation and congestion management rules; interoperability rules between transmission system operators; balancing rules; transparency of rules; harmonised transmission tariff structures. Tasks of the ENTSOG The ENTSOG is responsible for adopting: common network operation tools; a 10-year network development plan; recommendations for coordinated technical cooperation between EU TSOs; an annual work programme; an annual report; annual summer and winter supply outlooks. Costs and tariffs The regulatory authorities determine tariffs or methodologies for their calculation. EU countries may take decisions relating to tariffs such as fixing auction arrangements. Third-party access services TSOs must offer their services in a non-discriminatory manner to all network users.Detailed allocation rules are established in the Network Code on Capacity Allocation Mechanism. Liquefied natural gas and storage facility operators must also offer their services on a non-discriminatory basis and make them compatible with the use of interconnected gas transport networks. EU countries may decide whether access for storage is to be regulated or negotiated. Congestion management All market participants must have access to maximum network capacity as well as to storage and LNG facilities. TSOs must practise and publish transparent congestion-management* procedures which ensure that cross-border exchanges in gas are on a non-discriminatory basis. FROM WHEN DOES THE REGULATION APPLY? It has applied since 3 March 2011. It repealed Regulation (EC) No 1775/2005 from 3 March 2011. BACKGROUND For more information, see: Market legislation (European Commission) European Network of Transmission System Operators for Gas \u2014 ENTSOG (European Commission). KEY TERMS Transmission: transport of gas from production areas to end consumers by underground pipelines. Transmission system operator (TSO): a body that transports energy, such as natural gas, either nationally or regionally, using fixed infrastructure. Balancing: making receipts and deliveries of gas into or withdrawals from a company equal. Balancing may be accomplished daily, monthly or seasonally, with penalties generally assessed for excessive imbalance. Congestion management: congestion arises when the transmission system is not sufficient to transfer the power according to market desires. Congestion management ensures the use of the power available without violating the system constraints. MAIN DOCUMENT Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (OJ L 211, 14.8.2009, pp. 36-54) Successive amendments to Implementing Regulation (EC) No 715/2009) have been incorporated in the original text. This consolidated version is of documentary value only. RELATED ACTS Commission Regulation (EU) 2017/459 of 16 March 2017 establishing a network code on capacity allocation mechanisms in gas transmission systems and repealing Regulation (EU) No 984/2013 (OJ L 72, 17.3.2017, pp. 1-28) Commission Regulation (EU) 2017/460 of 16 March 2017 establishing a network code on harmonised transmission tariff structures for gas (OJ L 72, 17.3.2017, pp. 29-56) Commission Regulation (EU) 2015/703 of 30 April 2015 establishing a network code on interoperability and data exchange rules (OJ L 113, 1.5.2015, pp. 13-26) Commission Regulation (EU) No 312/2014 of 26 March 2014 establishing a Network Code on Gas Balancing of Transmission Networks (OJ L 91, 27.3.2014, pp. 15-35) last update 05.07.2018"}
{"article": "31.7.2009 EN Official Journal of the European Union L 200/25 REGULATION (EC) No 662/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 July 2009 establishing a procedure for the negotiation and conclusion of agreements between Member States and third countries on particular matters concerning the law applicable to contractual and non-contractual obligations THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Articles 61(c), 65 and 67(5) thereof, Having regard to the proposal from the Commission, Acting in accordance with the procedure laid down in Article 251 of the Treaty (1), Whereas: (1) Title IV of Part Three of the Treaty provides the legal basis for the adoption of Community legislation in the field of judicial cooperation in civil matters. (2) Judicial cooperation in civil matters between Member States and third countries has traditionally been governed by agreements between Member States and third countries. Such agreements, of which there is a large number, often reflect special ties between a Member State and a third country and are intended to provide an adequate legal framework to meet specific needs of the parties concerned. (3) Article 307 of the Treaty requires Member States to take all appropriate steps to eliminate any incompatibilities between the Community acquis and international agreements concluded between Member States and third countries. This may involve the need for the re-negotiation of such agreements. (4) In order to provide an adequate legal framework to meet specific needs of a given Member State in its relations with a third country, there may also be a manifest need for the conclusion of new agreements with third countries relating to areas of civil justice that come within the purview of Title IV of Part Three of the Treaty. (5) In its Opinion 1/03 of 7 February 2006 relating to the conclusion of the new Lugano Convention, the Court of Justice of the European Communities confirmed that the Community has acquired exclusive competence to conclude an international agreement like the Lugano Convention with third countries on matters affecting the rules laid down in Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (2) (Brussels I). (6) It is for the Community to conclude, pursuant to Article 300 of the Treaty, agreements between the Community and a third country on matters falling within the exclusive competence of the Community. (7) Article 10 of the Treaty requires Member States to facilitate the achievement of the Community\u2019s tasks and to abstain from any measure which could jeopardise the attainment of the objectives of the Treaty. This duty of loyal cooperation is of general application and does not depend on whether or not the Community competence is exclusive. (8) With regard to agreements with third countries on specific civil justice issues falling within the exclusive competence of the Community, a coherent and transparent procedure should be established to authorise a Member State to amend an existing agreement or to negotiate and conclude a new agreement, in particular where the Community itself has not indicated its intention to exercise its external competence to conclude an agreement by way of an already existing mandate of negotiation or an envisaged mandate of negotiation. This procedure should be without prejudice to the exclusive competence of the Community and the provisions of Articles 300 and 307 of the Treaty. It should be regarded as an exceptional measure and should be limited in scope and in time. (9) This Regulation should not apply if the Community has already concluded an agreement with the third country concerned on the same subject matter. Two agreements should be regarded as concerning the same subject matter only if, and to the extent that, they regulate in substance the same specific legal issues. Provisions simply stating a general intention to cooperate on such issues should not be regarded as concerning the same subject matter. (10) Exceptionally, certain regional agreements between a few Member States and a few third countries, for example two or three, intended to address local situations and not open for accession to other States should also be covered by this Regulation. (11) In order to ensure that an agreement envisaged by a Member State does not render Community law ineffective and does not undermine the proper functioning of the system established by that law, or undermine the Community\u2019s external relations policy as decided by the Community, the Member State concerned should be required to notify the Commission of its intentions with a view to obtaining an authorisation to open or continue formal negotiations on an agreement as well as to conclude an agreement. Such notification should be given by letter or by electronic means. It should contain all relevant information and documentation enabling the Commission to assess the expected impact on Community law of the outcome of the negotiations. (12) It should be assessed whether there is sufficient Community interest in concluding a bilateral agreement between the Community and the third country concerned or, where appropriate, in replacing an existing bilateral agreement between a Member State and a third country with a Community agreement. To that end, all Member States should be informed of any notification received by the Commission concerning an agreement envisaged by a Member State in order to allow them to demonstrate their interest in joining the initiative of the notifying Member State. If, from this exchange of information, a sufficient Community interest were to emerge, the Commission should consider proposing a negotiating mandate with a view to the conclusion of an agreement between the Community and the third country concerned. (13) If the Commission requests additional information from a Member State in connection with its assessment as to whether that Member State should be authorised to open negotiations with a third country, such a request should not affect the time limits within which the Commission is to give a reasoned decision on the application of that Member State. (14) When authorising the opening of formal negotiations, the Commission should be able, if necessary, to propose negotiating guidelines or request the inclusion of particular clauses in the envisaged agreement. The Commission should be kept fully informed throughout the different stages of the negotiations as far as matters falling within the scope of this Regulation are concerned and should be allowed to participate as an observer in the negotiations as regards those matters. (15) When notifying the Commission of their intention to enter into negotiations with a third country, Member States should only be required to inform the Commission of elements which are of relevance for the assessment to be made by the Commission. The authorisation by the Commission and any possible negotiating guidelines or, as the case may be, the refusal by the Commission should concern only matters falling within the scope of this Regulation. (16) All Member States should be informed of any notification to the Commission concerning envisaged or negotiated agreements and of any reasoned decision by the Commission under this Regulation. Such information should however fully comply with possible confidentiality requirements. (17) The European Parliament, the Council and the Commission should ensure that any information identified as confidential is treated in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (3). (18) Where the Commission, on the basis of its assessment, intends not to authorise the opening of formal negotiations or the conclusion of a negotiated agreement, it should, before giving its reasoned decision, give an opinion to the Member State concerned. In the case of refusal to authorise the conclusion of a negotiated agreement the opinion should also be submitted to the European Parliament and to the Council. (19) In order to ensure that the negotiated agreement does not constitute an obstacle to the implementation of the Community\u2019s external policy on judicial cooperation in civil and commercial matters, the agreement should provide either for its full or partial denunciation in the event of the conclusion of a subsequent agreement between the Community or the Community and its Member States, on the one hand, and the same third country, on the other hand, on the same subject matter, or for a direct replacement of the relevant provisions of the agreement by the provisions of such subsequent agreement. (20) Provision should be made for transitional measures to cover situations where, at the time of the entry into force of this Regulation, a Member State has already started the process of negotiating an agreement with a third country, or has completed the negotiations but has not yet expressed its consent to be bound by the agreement. (21) In order to ensure that sufficient experience has been gained concerning the application of this Regulation, the Commission should submit a report on such application no earlier than eight years after the adoption of this Regulation. In that report, the Commission, exercising its prerogatives, should confirm the temporary nature of this Regulation or examine whether this Regulation should be replaced by a new Regulation covering the same subject matter or including also particular matters falling within the exclusive competence of the Community and governed by other Community instruments, as referred to in recital 5. (22) If the report submitted by the Commission confirms the temporary nature of this Regulation, Member States should still be able, after the submission of the report, to notify the Commission of ongoing or already announced negotiations with a view to obtaining an authorisation to open formal negotiations. (23) In accordance with the principle of proportionality, as set out in Article 5 of the Treaty, this Regulation does not go beyond what is necessary in order to achieve its objective. (24) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom and Ireland have given notice of their wish to take part in the adoption and application of this Regulation. (25) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. This Regulation establishes a procedure to authorise a Member State to amend an existing agreement or to negotiate and conclude a new agreement with a third country, subject to the conditions laid down in this Regulation. This procedure is without prejudice to the respective competencies of the Community and of the Member States. 2. This Regulation shall apply to agreements concerning particular matters falling, entirely or partly, within the scope of Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (4) and Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) (5). 3. This Regulation shall not apply if the Community has already concluded an agreement with the third country concerned on the same subject matter. Article 2 Definitions 1. For the purposes of this Regulation, the term \u2018agreement\u2019 shall mean: (a) a bilateral agreement between a Member State and a third country; (b) a regional agreement between a limited number of Member States and of third countries neighbouring Member States which is intended to address local situations and which is not open for accession to other States. 2. In the context of regional agreements as referred to in paragraph 1(b), any reference in this Regulation to a Member State or a third country shall be read as referring to the Member States or the third countries concerned, respectively. Article 3 Notification to the Commission 1. Where a Member State intends to enter into negotiations in order to amend an existing agreement or to conclude a new agreement falling within the scope of this Regulation, it shall notify the Commission in writing of its intention at the earliest possible moment before the envisaged opening of formal negotiations. 2. The notification shall include, as appropriate, a copy of the existing agreement, the draft agreement or the draft proposal, and any other relevant documentation. The Member State shall describe the subject matter of the negotiations and specify the issues which are to be addressed in the envisaged agreement, or the provisions of the existing agreement which are to be amended. The Member State may provide any other additional information. Article 4 Assessment by the Commission 1. Upon receipt of the notification referred to in Article 3, the Commission shall assess whether the Member State may open formal negotiations. 2. In making that assessment, the Commission shall first check whether any relevant negotiating mandate with a view to concluding a Community agreement with the third country concerned is specifically envisaged within the next 24 months. If this is not the case, the Commission shall assess whether all of the following conditions are met: (a) the Member State concerned has provided information showing that it has a specific interest in concluding the agreement due to economic, geographic, cultural, historical, social or political ties between the Member State and the third country concerned; (b) on the basis of the information provided by the Member State, the envisaged agreement appears not to render Community law ineffective and not to undermine the proper functioning of the system established by that law; and (c) the envisaged agreement would not undermine the object and purpose of the Community\u2019s external relations policy as decided by the Community. 3. If the information provided by the Member State is not sufficient for the purposes of the assessment, the Commission may request additional information. Article 5 Authorisation to open formal negotiations 1. If the envisaged agreement meets the conditions set out in Article 4(2), the Commission shall, within 90 days of receipt of the notification referred to in Article 3, give a reasoned decision on the application of the Member State authorising it to open formal negotiations on that agreement. If necessary, the Commission may propose negotiating guidelines and may request the inclusion of particular clauses in the envisaged agreement. 2. The envisaged agreement shall contain a clause providing for either: (a) full or partial denunciation of the agreement in the event of the conclusion of a subsequent agreement between the Community or the Community and its Member States, on the one hand, and the same third country, on the other hand, on the same subject matter; or (b) direct replacement of the relevant provisions of the agreement by the provisions of a subsequent agreement concluded between the Community or the Community and its Member States, on the one hand, and the same third country, on the other hand, on the same subject matter. The clause referred to in point (a) of the first subparagraph should be worded along the following lines: \u2018(name(s) of the Member State(s)) shall denounce this Agreement, in part or in full, if and when the European Community or the European Community and its Member States conclude an Agreement with (name(s) of the third country(ies)) on the same matters of civil justice as those governed by this Agreement\u2019. The clause referred to in point (b) of the first subparagraph should be worded along the following lines: \u2018This Agreement or certain provisions of this Agreement shall cease to be applicable on the day when an Agreement between the European Community or the European Community and its Member States, on the one hand, and (name(s) of the third country(ies)), on the other hand, has entered into force, in respect of the matters governed by the latter Agreement\u2019. Article 6 Refusal to authorise the opening of formal negotiations 1. If, on the basis of its assessment under Article 4, the Commission intends not to authorise the opening of formal negotiations on the envisaged agreement, it shall give an opinion to the Member State concerned within 90 days of receipt of the notification referred to in Article 3. 2. Within 30 days of receipt of the opinion of the Commission, the Member State concerned may request the Commission to enter into discussions with it with a view to finding a solution. 3. If the Member State concerned does not request the Commission to enter into discussions with it within the time limit provided for in paragraph 2, the Commission shall give a reasoned decision on the application of the Member State within 130 days of receipt of the notification referred to in Article 3. 4. In the event of the discussions referred to in paragraph 2, the Commission shall give a reasoned decision on the application of the Member State within 30 days of the closure of the discussions. Article 7 Participation of the Commission in the negotiations The Commission may participate as an observer in the negotiations between the Member State and the third country as far as matters falling within the scope of this Regulation are concerned. If the Commission does not participate as an observer, it shall be kept informed of the progress and results throughout the different stages of the negotiations. Article 8 Authorisation to conclude the agreement 1. Before signing a negotiated agreement, the Member State concerned shall notify the outcome of the negotiations to the Commission and shall transmit to it the text of the agreement. 2. Upon receipt of that notification the Commission shall assess whether the negotiated agreement: (a) meets the condition set out in Article 4(2)(b); (b) meets the condition set out in Article 4(2)(c), in so far as there are new and exceptional circumstances in relation to that condition; and (c) fulfils the requirement under Article 5(2). 3. If the negotiated agreement fulfils the conditions and requirements referred to in paragraph 2, the Commission shall, within 90 days of receipt of the notification referred to in paragraph 1, give a reasoned decision on the application of the Member State authorising it to conclude that agreement. Article 9 Refusal to authorise the conclusion of the agreement 1. If, on the basis of its assessment under Article 8(2), the Commission intends not to authorise the conclusion of the negotiated agreement, it shall give an opinion to the Member State concerned, as well as to the European Parliament and to the Council, within 90 days of receipt of the notification referred to in Article 8(1). 2. Within 30 days of receipt of the opinion of the Commission, the Member State concerned may request the Commission to enter into discussions with it with a view to finding a solution. 3. If the Member State concerned does not request the Commission to enter into discussions with it within the time limit provided for in paragraph 2, the Commission shall give a reasoned decision on the application of the Member State within 130 days of receipt of the notification referred to in Article 8(1). 4. In the event of the discussions referred to in paragraph 2, the Commission shall give a reasoned decision on the application of the Member State within 30 days of the closure of the discussions. 5. The Commission shall notify its decision to the European Parliament and to the Council within 30 days of the decision. Article 10 Confidentiality When providing information to the Commission under Articles 3, 4(3) and 8, the Member State may indicate whether any of the information is to be regarded as confidential and whether the information provided can be shared with other Member States. Article 11 Provision of information to the Member States The Commission shall send to the Member States the notifications received under Articles 3 and 8 and, if necessary, the accompanying documents, as well as all its reasoned decisions under Articles 5, 6, 8 and 9, subject to the confidentiality requirements. Article 12 Transitional provisions 1. Where, at the time of entry into force of this Regulation, a Member State has already started the process of negotiating an agreement with a third country, Articles 3 to 11 shall apply. Where the stage of the negotiations so permits, the Commission may propose negotiating guidelines or request the inclusion of particular clauses, as referred to in the second subparagraph of Article 5(1) and Article 5(2) respectively. 2. Where, at the time of entry into force of this Regulation, a Member State has already completed the negotiations but has not yet concluded the agreement, Article 3, Article 8(2) to (4) and Article 9 shall apply. Article 13 Review 1. No earlier than 13 July 2017 the Commission shall submit to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Regulation. 2. That report shall either: (a) confirm that it is appropriate for this Regulation to expire on the date determined in accordance with Article 14(1); or (b) recommend that this Regulation be replaced as of that date by a new Regulation. 3. If the report recommends a replacement of this Regulation as referred to in paragraph 2(b), it shall be accompanied by an appropriate legislative proposal. Article 14 Expiry 1. This Regulation shall expire three years after the submission by the Commission of the report referred to in Article 13. The period of three years referred to in the first subparagraph shall start to run on the first day of the month following the submission of the report to either the European Parliament or the Council, whichever is the later. 2. Notwithstanding the expiry of this Regulation on the date determined in accordance with paragraph 1, all negotiations ongoing on that date which have been entered into by a Member State under this Regulation shall be allowed to continue and to be completed in accordance with this Regulation. Article 15 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaty establishing the European Community. Done at Brussels, 13 July 2009. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President E. ERLANDSSON (1) Opinion of the European Parliament of 7 May 2009 (not yet published in the Official Journal) and Council Decision of 7 July 2009. (2) OJ L 12, 16.1.2001, p. 1. (3) OJ L 145, 31.5.2001, p. 43. (4) OJ L 177, 4.7.2008, p. 6. (5) OJ L 199, 31.7.2007, p. 40.", "summary": "Civil judicial cooperation and agreements with non-EU countries Civil judicial cooperation and agreements with non-EU countries SUMMARY OF: Regulation (EC) No 662/2009 \u2014 negotiation and conclusion of agreements between EU and non-EU countries in regard to the law applicable to contractual and non-contractual obligations WHAT IS THE AIM OF THIS REGULATION? It aims at ensuring coherence in the EU\u2019s external action in an area now falling within the exclusive competence of the EU. It establishes a procedure of authorisation for an EU country to amend an existing agreement or \u2013\u2013 to negotiate and conclude a new agreement with a non-EU country related to specific matters of applicable law in contractual and non-contractual obligations*. The procedure is subject to strict rules and has to be considered exceptional. KEY POINTS Scope: the regulation applies to agreements concerning particular matters falling, entirely or partly, within the scope of Regulation (EC) No 593/2008 on the law applicable to contractual obligations (Rome I) and Regulation (EC) No 864/2007 on the law applicable to non-contractual obligations (Rome II). Notification: where an EU country intends to enter into negotiations in order to amend an existing agreement or to conclude a new agreement falling within the scope of the regulation, it must notify the European Commission in writing of its intention as soon as possible before the envisaged opening of formal negotiations. Confidentiality: the Commission has to treat the information communicated by the EU country as confidential, if so requested. Assessment: the Commission must: firstly, check that no relevant negotiating mandate for concluding an EU-level agreement with the non-EU country concerned is envisaged within the next 24 months; if not, verify that there is a genuine specific interest of the EU country for the agreement and that the envisaged agreement would not undermine the effectiveness of EU law and the object and purpose of the EU external relations policy; and if necessary, request further information. Authorisation of negotiations: if the conditions are met, the Commission authorises the EU country to open formal negotiations on the agreement. The Commission may propose negotiating guidelines as well as the inclusion of particular clauses in the envisaged agreement. Participation: the Commission may participate as an observer in the negotiations, and otherwise should be kept informed of progress and results. Clauses in the agreement: where is is authorised, the agreement will in any case have to stipulate that the agreement is fully or partially terminated in the event of a subsequent agreement between the EU and the same non-EU country on the same subject matter; and that a subsequent agreement between the EU and the non-EU country on the same subject matter direct replace the relevant clauses of the agreement. Authorisation of conclusion: before signing the agreement, the EU country must notify the outcome of the negotiations and submit the text of the agreement to the Commission, for authorisation of conclusion after verifying that the conditions are met. Refusal: the regulation sets out the procedure for and consequences of the Commission\u2019s refusal to authorise negotiations or the conclusion of the agreement. Review and expiry The regulation expires 3 years after the submission by the Commission \u2014 no earlier than 7 July 2017 \u2014 of a report on its application. In that report, the Commission must indicate whether it recommends that this regulation be replaced at its expiry by a new regulation. Any negotiation underway at the date of expiry may continue. FROM WHEN DOES THE REGULATION APPLY? It has applied since 20 August 2009. BACKGROUND This regulation should be seen in the context of the EU\u2019s exclusive external competence for these areas of civil law. Before the adoption of the relevant internal EU Regulations (Rome I and Rome II), the EU countries themselves concluded agreements with non-EU countries in this area. As part of the EU approach to judicial cooperation and agreements with non-EU countries in civil matters, this regulation comes along with Regulation (EC) No 664/2009 concerning jurisdiction, recognition and enforcement of judgments and decisions in matrimonial matters, parental responsibility and maintenance obligations which entered into force the same day and is based on a similar procedure. For more information, see: Civil and commercial matters (European Commission). KEY TERMS Non-contractual obligation: where a person who is responsible for loss sustained by another person outside the performance of a contract \u2013 e.g. due to a tort or by unjust enrichment \u2013 is required to compensate the loss. MAIN DOCUMENT Regulation (EC) No 662/2009 of the European Parliament and of the Council of 13 July 2009 establishing a procedure for the negotiation and conclusion of agreements between Member States and third countries on particular matters concerning the law applicable to contractual and non-contractual obligations (OJ L 200, 31.7.2009, pp. 25-30) Successive amendments to Regulation (EC) No 662/2009 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Council Regulation (EC) No 664/2009 of 7 July 2009 establishing a procedure for the negotiation and conclusion of agreements between Member States and third countries concerning jurisdiction, recognition and enforcement of judgments and decisions in matrimonial matters, matters of parental responsibility and matters relating to maintenance obligations, and the law applicable to matters relating to maintenance obligations (OJ L 200, 31.7.2009, pp. 46-51) See consolidated version Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (OJ L 177, 4.7.2008, pp. 6-16) See consolidated version Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) (OJ L 199, 31.7.2007, pp. 40-49) last update 06.12.2017"}
{"article": "31.7.2007 EN Official Journal of the European Union L 199/23 REGULATION (EC) No 862/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 July 2007 on Community statistics on migration and international protection and repealing Council Regulation (EEC) No 311/76 on the compilation of statistics on foreign workers (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The conclusions of the Justice and Home Affairs Council of 28-29 May 2001 considered, regarding common analysis and the improved exchange of statistics on asylum and migration, that there is a need for a comprehensive and coherent framework for future action on improving statistics. (2) In April 2003, the Commission released a Communication to the Council and to the European Parliament, setting out an Action Plan for the collection and analysis of Community Statistics in the field of migration. This included a number of important changes designed to improve the completeness and degree of harmonisation of these statistics. Under the Action Plan, the Commission aimed to propose legislation on Community statistics on migration and asylum. (3) The Thessaloniki European Council of 19 and 20 June 2003 concluded that more effective mechanisms were needed for the collection and analysis of information on migration and asylum in the European Union. (4) The European Parliament in its resolution of 6 November 2003 (3) on the abovementioned Communication from the Commission noted that legislation was required to ensure the production of comprehensive statistics necessary for the development of fair and effective Community policies on migration. The resolution supports the Commission's plans to propose legislation for migration and asylum statistics. (5) Enlargement of the European Union has brought an added geographical and political dimension to the scale of the phenomena associated with migration. It has also brought a further impetus to the demand for accurate, timely and harmonised statistical information. There is also an increasing need for statistical information regarding the profession, education, qualifications and type of activity of migrants. (6) Harmonised and comparable Community statistics on migration and asylum are essential for the development and monitoring of Community legislation and policies relating to immigration and asylum, and to the free movement of persons. (7) There is a need to reinforce the exchange of statistical information on asylum and migration and to improve the quality of Community statistical collections and outputs which have, hitherto, taken place on the basis of a series of \u2018gentlemen's agreements\u2019. (8) It is essential that information be available, throughout the European Union, for the purposes of monitoring the development and implementation of Community legislation and policy. In the main, current practice does not sufficiently ensure, in a uniform manner, regular, timely and rapid delivery and dissemination of harmonised data. (9) This Regulation does not cover estimates of the number of persons illegally resident in the Member States. Member States should not provide such estimates or data on such persons to the Commission (Eurostat), although they may be included in population stocks due to surveys. (10) Wherever possible, the definitions used for the purposes of this Regulation are taken from the United Nations Recommendations on Statistics of International Migration, the United Nations Recommendations for the Censuses of Population and Housing in the ECE Region or EC legislation, and should be updated following the relevant procedures. (11) New Community needs on statistics on migration and asylum render obsolete the provisions of Council Regulation (EEC) No 311/76 of 9 February 1976 on the compilation of statistics on foreign workers (4). (12) Regulation (EEC) No 311/76 should therefore be repealed. (13) Since the objective of this Regulation to establish common rules for the collection and compilation of Community statistics on migration and international protection cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (14) Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (5) constitutes the reference framework for the provisions of this Regulation. In particular, it requires conformity to standards of impartiality, reliability, objectivity, scientific independence, cost-effectiveness and statistical confidentiality. (15) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6). (16) In particular, the Commission should be empowered to update the definitions, to decide on the groupings of data and additional disaggregations and to lay down the rules on accuracy and quality standards. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation and to supplement it by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny laid down in Article 5a of Decision 1999/468/EC. (17) The Statistical Programme Committee, established by Council Decision 89/382/EEC, Euratom of 19 June 1989 establishing a Committee on the Statistical Programmes of the European Communities (7), has been consulted in accordance with Article 3 of that Decision, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes common rules for the collection and compilation of Community statistics on: (a) immigration to and emigration from the Member State territories, including flows from the territory of one Member State to that of another Member State and flows between a Member State and the territory of a third country; (b) the citizenship and country of birth of persons usually resident in the territory of the Member States; (c) administrative and judicial procedures and processes in the Member States relating to immigration, granting of permission to reside, citizenship, asylum and other forms of international protection and the prevention of illegal immigration. Article 2 Definitions 1. For the purposes of this Regulation, the following definitions shall apply: (a) \u2018usual residence\u2019 means the place at which a person normally spends the daily period of rest, regardless of temporary absences for purposes of recreation, holiday, visits to friends and relatives, business, medical treatment or religious pilgrimage or, in default, the place of legal or registered residence; (b) \u2018immigration\u2019 means the action by which a person establishes his or her usual residence in the territory of a Member State for a period that is, or is expected to be, of at least 12 months, having previously been usually resident in another Member State or a third country; (c) \u2018emigration\u2019 means the action by which a person, having previously been usually resident in the territory of a Member State, ceases to have his or her usual residence in that Member State for a period that is, or is expected to be, of at least 12 months; (d) \u2018citizenship\u2019 means the particular legal bond between an individual and his or her State, acquired by birth or naturalisation, whether by declaration, choice, marriage or other means according to national legislation; (e) \u2018country of birth\u2019 means the country of residence (in its current borders, if the information is available) of the mother at the time of the birth or, in default, the country (in its current borders, if the information is available) in which the birth took place; (f) \u2018immigrant\u2019 means a person undertaking an immigration; (g) \u2018emigrant\u2019 means a person undertaking an emigration; (h) \u2018long-term resident\u2019 means long-term resident as defined in Article 2(b) of Council Directive 2003/109/EC of 25 November 2003 concerning the status of third-country nationals who are long-term residents (8); (i) \u2018third-country national\u2019 means any person who is not a citizen of the Union within the meaning of Article 17(1) of the Treaty, including stateless persons; (j) \u2018application for international protection\u2019 means application for international protection as defined in Article 2(g) of Council Directive 2004/83/EC of 29 April 2004 on minimum standards for the qualification and status of third-country nationals or stateless persons as refugees or as persons who otherwise need international protection and the content of the protection granted (9); (k) \u2018refugee status\u2019 means refugee status as defined in Article 2(d) of Directive 2004/83/EC; (l) \u2018subsidiary protection status\u2019 means subsidiary protection status as defined in Article 2(f) of Directive 2004/83/EC; (m) \u2018family members\u2019 means family members as defined in Article 2(i) of Council Regulation (EC) No 343/2003 of 18 February 2003 establishing the criteria and mechanisms for determining the Member State responsible for examining an asylum application lodged in one of the Member States by a third-country national (10); (n) \u2018temporary protection\u2019 means temporary protection as defined in Article 2(a) of Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof (11); (o) \u2018unaccompanied minor\u2019 means an unaccompanied minor as defined in Article 2(i) of Directive 2004/83/EC; (p) \u2018external borders\u2019 means external borders as defined in Article 2(2) of Regulation (EC) No 562/2006 of the European Parliament and of the Council of 15 March 2006 establishing a Community Code on the rules governing the movement of persons across borders (Schengen Borders Code) (12); (q) \u2018third-country nationals refused entry\u2019 means third-country nationals who are refused entry at the external border because they do not fulfil all the entry conditions laid down in Article 5(1) of Regulation (EC) No 562/2006 and do not belong to the categories of persons referred to in Article 5(4) of that Regulation; (r) \u2018third-country nationals found to be illegally present\u2019 means third-country nationals who are officially found to be on the territory of a Member State and who do not fulfil, or no longer fulfil, the conditions for stay or residence in that Member State; (s) \u2018resettlement\u2019 means the transfer of third-country nationals or stateless persons on the basis of an assessment of their need for international protection and a durable solution, to a Member State, where they are permitted to reside with a secure legal status. 2. Member States shall report to the Commission (Eurostat) on the use and probable effects of estimations or other methods of adapting statistics based on national definitions to comply with the harmonised definitions set out in paragraph 1. 3. For the reference year 2008, the statistics supplied to the Commission (Eurostat) under this Regulation may be based on alternative (national) definitions. In such cases, Member States shall notify the Commission (Eurostat) of these alternative definitions. 4. If a Member State is not bound by one or more of the legal texts referred to in the definitions in paragraph 1, statistics comparable with those required under this Regulation should be provided by that Member State where they can be provided under existing legislative and/or administrative procedures. Article 3 Statistics on international migration, usually resident population and acquisition of citizenship 1. Member States shall supply to the Commission (Eurostat) statistics on the numbers of: (a) immigrants moving to the territory of the Member State, disaggregated as follows: (i) groups of citizenship by age and sex; (ii) groups of country of birth by age and sex; (iii) groups of country of previous usual residence by age and sex; (b) emigrants moving from the territory of the Member State disaggregated as follows: (i) groups of citizenships; (ii) age; (iii) sex; (iv) groups of countries of next usual residence; (c) persons having their usual residence in the Member State at the end of the reference period, disaggregated as follows: (i) groups of citizenship by age and sex; (ii) groups of country of birth by age and sex; (d) persons having their usual residence in the territory of the Member State and having acquired during the reference year the citizenship of the Member State and having formerly held the citizenship of another Member State or a third country or having formerly been stateless, disaggregated by age and sex, and by the former citizenship of the persons concerned and by whether the person was formerly stateless. 2. The statistics referred to in paragraph 1 shall relate to reference periods of one calendar year and shall be supplied to the Commission (Eurostat) within 12 months of the end of the reference year. The first reference year shall be 2008. Article 4 Statistics on international protection 1. Member States shall supply to the Commission (Eurostat) statistics on the numbers of: (a) persons having submitted an application for international protection or having been included in such an application as a family member during the reference period; (b) persons who are the subject of applications for international protection under consideration by the responsible national authority at the end of the reference period; (c) applications for international protection having been withdrawn during the reference period. These statistics shall be disaggregated by age and sex, and by the citizenship of the persons concerned. They shall relate to reference periods of one calendar month and shall be supplied to the Commission (Eurostat) within two months of the end of the reference month. The first reference month shall be January 2008. 2. Member States shall supply to the Commission (Eurostat) statistics on the numbers of: (a) persons covered by first instance decisions rejecting applications for international protection, such as decisions considering applications as inadmissible or as unfounded and decisions under priority and accelerated procedures, taken by administrative or judicial bodies during the reference period; (b) persons covered by first instance decisions granting or withdrawing refugee status, taken by administrative or judicial bodies during the reference period; (c) persons covered by first instance decisions granting or withdrawing subsidiary protection status, taken by administrative or judicial bodies during the reference period; (d) persons covered by first instance decisions granting or withdrawing temporary protection, taken by administrative or judicial bodies during the reference period; (e) persons covered by other first instance decisions granting or withdrawing authorisation to stay for humanitarian reasons under national law concerning international protection, taken by administrative or judicial bodies during the reference period. These statistics shall be disaggregated by age and sex, and by the citizenship of the persons concerned. They shall relate to reference periods of three calendar months and shall be supplied to the Commission (Eurostat) within two months of the end of the reference period. The first reference period shall be January to March 2008. 3. Member States shall supply to the Commission (Eurostat) statistics on the numbers of: (a) applicants for international protection who are considered by the responsible national authority to be unaccompanied minors during the reference period; (b) persons covered by final decisions rejecting applications for international protection, such as decisions considering applications as inadmissible or as unfounded and decisions under priority and accelerated procedures, taken by administrative or judicial bodies in appeal or review during the reference period; (c) persons covered by final decisions granting or withdrawing refugee status taken by administrative or judicial bodies in appeal or review during the reference period; (d) persons covered by final decisions granting or withdrawing subsidiary protection status taken by administrative or judicial bodies in appeal or review during the reference period; (e) persons covered by final decisions granting or withdrawing temporary protection taken by administrative or judicial bodies in appeal or review during the reference period; (f) persons covered by other final decisions, taken by administrative or judicial bodies in appeal or review, granting or withdrawing authorisations to stay for humanitarian reasons under national law concerning international protection during the reference period; (g) persons who have been granted an authorisation to reside in a Member State within the framework of a national or Community resettlement scheme during the reference period, where such a scheme is implemented in that Member State. These statistics shall be disaggregated by age and sex, and by the citizenship of the persons concerned. They shall relate to reference periods of one calendar year and shall be supplied to the Commission (Eurostat) within three months of the end of the reference year. The first reference year shall be 2008. 4. Member States shall supply to the Commission (Eurostat) the following statistics on the application of Regulation (EC) No 343/2003 and Commission Regulation (EC) No 1560/2003 of 2 September 2003 laying down detailed rules for the application of Council Regulation (EC) No 343/2003 (13): (a) the numbers of requests for taking back or taking charge of an asylum seeker; (b) the provisions on which the requests referred to in point (a) are based; (c) the decisions taken in response to the requests referred to in point (a); (d) the numbers of transfers to which the decisions referred to in point (c) lead; (e) the number of requests for information. These statistics shall relate to reference periods of one calendar year and shall be supplied to the Commission (Eurostat) within three months of the end of the reference year. The first reference year shall be 2008. Article 5 Statistics on the prevention of illegal entry and stay 1. Member States shall supply to the Commission (Eurostat) statistics on the numbers of: (a) third-country nationals refused entry to the Member State's territory at the external border; (b) third-country nationals found to be illegally present in the Member State's territory under national laws relating to immigration. The statistics under point (a) shall be disaggregated in accordance with Article 13(5) of Regulation (EC) No 562/2006. The statistics under point (b) shall be disaggregated by age and sex, and by citizenship of the persons concerned. 2. The statistics referred to in paragraph 1 shall relate to reference periods of one calendar year and shall be supplied to the Commission (Eurostat) within three months of the end of the reference year. The first reference year shall be 2008. Article 6 Statistics on residence permits and residence of third-country nationals 1. Member States shall supply to the Commission (Eurostat) statistics on: (a) the number of residence permits issued to persons who are third-country nationals, disaggregated as follows: (i) permits issued during the reference period whereby the person is being granted permission to reside for the first time, disaggregated by citizenship, by the reason for the permit being issued and by the length of validity of the permit; (ii) permits issued during the reference period and granted on the occasion of a person changing immigration status or reason for stay, disaggregated by citizenship, by the reason for the permit being issued and by the length of validity of the permit; (iii) valid permits at the end of the reference period (number of permits issued, not withdrawn and not expired), disaggregated by citizenship, by the reason for the issue of the permit and by the length of validity of the permit; (b) the number of long-term residents at the end of the reference period, disaggregated by citizenship. 2. Where the national laws and administrative practices of a Member State allow for specific categories of long-term visa or immigration status to be granted instead of residence permits, counts of such visas and grants of status are to be included in the statistics required under paragraph 1. 3. The statistics referred to in paragraph 1 shall relate to reference periods of one calendar year and shall be supplied to the Commission (Eurostat) within six months of the end of the reference year. The first reference year shall be 2008. Article 7 Statistics on returns 1. Member States shall supply to the Commission (Eurostat) statistics relating to: (a) the number of third-country nationals found to be illegally present in the territory of the Member State who are subject to an administrative or judicial decision or act stating or declaring that their stay is illegal and imposing an obligation to leave the territory of the Member State, disaggregated by citizenship of the persons concerned; (b) the number of third-country nationals who have in fact left the territory of the Member State, following an administrative or judicial decision or act, as referred to in point (a), disaggregated by the citizenship of the persons returned. 2. The statistics referred to in paragraph 1 shall relate to reference periods of one calendar year and shall be supplied to the Commission (Eurostat) within three months of the end of the reference year. The first reference year shall be 2008. 3. The statistics referred to in paragraph 1 shall not include third-country nationals who are transferred from one Member State to another Member State under the mechanism established by Regulations (EC) No 343/2003 and (EC) No 1560/2003. Article 8 Additional disaggregations 1. The Commission may adopt measures relating to the definition of additional disaggregations as set out below for the following statistics: (a) for statistics required under Article 4 as a whole, disaggregations by: (i) year of submission of the application; (b) for statistics required under Article 4(4), disaggregations by: (i) number of persons concerned by the request, decision and transfer; (c) for statistics required under Article 5(1)(a), disaggregations by: (i) age; (ii) sex; (d) for statistics required under Article 5(1)(b), disaggregations by: (i) grounds for the apprehension; (ii) place of the apprehension; (e) for statistics required under Article 6, disaggregations by: (i) year in which permission to reside was first granted; (ii) age; (iii) sex; (f) for statistics required under Article 7, disaggregations by: (i) reason for the decision or act imposing an obligation to leave; (ii) age; (iii) sex. 2. The additional disaggregations mentioned in paragraph 1 shall be supplied only separately, and not cross-classified with the disaggregations required under Articles 4 to 7. 3. When deciding whether additional disaggregations are required, the Commission shall consider the need for this information for the purposes of developing and monitoring Community policies and shall consider the availability of appropriate data sources and the costs involved. Negotiations on additional disaggregations that may be needed for the application of Articles 4 to 7 shall be initiated not later than 20 August 2009. The earliest reference year for the implementation of additional disaggregations shall be 2010. Article 9 Data sources and quality standards 1. The statistics shall be based on the following data sources according to their availability in the Member State and in accordance with national laws and practices: (a) records of administrative and judicial actions; (b) registers relating to administrative actions; (c) registers of the population of persons or of a particular sub-group of that population; (d) censuses; (e) sample surveys; (f) other appropriate sources. As part of the statistics process, scientifically based and well documented statistical estimation methods may be used. 2. Member States shall report to the Commission (Eurostat) on the data sources used, the reasons for the selection of these sources and the effects of the selected data sources on the quality of the statistics, and on the estimation methods used, and shall keep the Commission (Eurostat) informed of changes thereto. 3. At the request of the Commission (Eurostat), Member States shall provide it with all the information necessary to evaluate the quality, comparability and completeness of the statistical information. 4. Member States shall inform the Commission (Eurostat) without delay of revisions and corrections to the statistics supplied under this Regulation, and of any changes in the methods and data sources used. 5. The measures relating to the definition of the appropriate formats for the transmission of data shall be adopted in accordance with the regulatory procedure referred to in Article 11(2). Article 10 Implementing measures 1. The measures necessary for the implementation of this Regulation laying down the rules on the appropriate formats for the transmission of data as provided for in Article 9 shall be adopted in accordance with the regulatory procedure referred to in Article 11(2). 2. The following measures necessary for the implementation of this Regulation and designed to amend its non-essential elements, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3): (a) updating the definitions set out in Article 2(1); (b) defining the categories of groups of country of birth, groups of country of previous and next usual residence and groups of citizenship as provided for in Article 3(1); (c) defining the categories of the reasons for the permit as provided for in Article 6(1)(a); (d) defining the additional disaggregations and the levels of disaggregations to be applied to the variables as provided for in Article 8; (e) laying down the rules on accuracy and quality standards. Article 11 Committee 1. In adopting the implementing measures, the Commission shall be assisted by the Statistical Programme Committee, established by Decision 89/382/EEC, Euratom. 2. Where reference is made to this paragraph, Article 5 and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 12 Report By 20 August 2012 and every three years thereafter, the Commission shall submit a report to the European Parliament and the Council on the statistics compiled pursuant to this Regulation and on their quality. Article 13 Repeal Regulation (EEC) No 311/76 is hereby repealed. Article 14 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 July 2007. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President M. LOBO ANTUNES (1) OJ C 185, 8.8.2006, p. 31. (2) Opinion of the European Parliament of 14 March 2007 (not yet published in the Official Journal) and Council Decision of 12 June 2007. (3) OJ C 83 E, 2.4.2004, p. 94. (4) OJ L 39, 14.2.1976, p. 1. (5) OJ L 52, 22.2.1997, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council (OJ L 284, 31.10.2003, p. 1). (6) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (7) OJ L 181, 28.6.1989, p. 47. (8) OJ L 16, 23.1.2004, p. 44. (9) OJ L 304, 30.9.2004, p. 12. (10) OJ L 50, 25.2.2003, p. 1. (11) OJ L 212, 7.8.2001, p. 12. (12) OJ L 105, 13.4.2006, p. 1. (13) OJ L 222, 5.9.2003, p. 3.", "summary": "Migration statistics Migration statistics SUMMARY OF: Regulation (EC) No 862/2007 \u2014 EU statistics on migration and international protection WHAT IS THE AIM OF THE REGULATION? Regulation (EC) No 862/2007 sets out EU rules for collecting and compiling statistics on migration (emigration* and immigration*), international protection (asylum), regular and irregular migration* and returns by EU and EFTA countries. To ensure reliable, relevant and timely statistics are available in the area of migration and international protection, and to support the European Agenda on Migration, amending Regulation (EU) 2020/851 introduces additional statistics to be collected by Eurostat and adds rules for introducing pilot studies to test the feasibility of new data collections or disaggregations within the scope of Regulation (EC) No 862/2007. KEY POINTS Statistical requirementsThe regulation sets out the statistical requirements for different categories of data: For international migration, EU countries must provide Eurostat with statistics on: immigrants moving to their territories;emigrants moving from their territories;persons usually resident on their territories;persons having acquired national citizenship. For residence permits and residence of non-EU citizens, EU countries must provide Eurostat with statistics on: residence permits issued, permits issued due to the change of immigration status or reason to stay; and long-term residence permits issued;the numbers of valid residence permits and long-term residence permits. For international protection, EU countries must provide Eurostat with statistics on: persons applying for international protection including first-time and subsequent applications;unaccompanied children applying for international protection;pending applications for international protection;withdrawn asylum applications;applications processed under accelerated procedure;applicants benefiting from material reception conditions;rejected applications for international protection;grants of refugee, subsidiary protection, national humanitarian and temporary protection statuses;requests and re-examination requests, decisions and transfers under the Dublin III Regulation;beneficiaries of resettlement*. For the prevention of irregular entry and stay, and for returns, EU countries must provide statistics on the number of: non-EU citizens who have been refused entry at their external borders;non-EU citizens who have been found illegally present on their territories;administrative or judicial decisions imposing an obligation to leave their territories;the number of non-EU citizens who are returned having been given an order to leave. Data sources The statistics are based on a number of sources including: records of administrative and judicial actions; registers of the population or relating to administrative actions; censuses; sample surveys. In general, the statistics are broken down by age, sex and citizenship. However, data are also collected for other categories such as the reason for issuing a residence permit or country of birth and country of previous or next residence for migration data. Pilot studies Amending Regulation (EU) 2020/851 introduces pilot studies to test the feasibility of new data collections or disaggregations within the scope of Regulation (EC) No 862/2007. Financial contributions from the EU budget are available for national institutes to: develop new methodologies for statistics on migration and international protection; and develop or implement new data collections and disaggregations, including the upgrading of data sources and IT systems, for a period of up to 5 years. Implementation The European Commission submits a report to the European Parliament and the Council on the implementation of the regulation every 3 years. The 2018 report found clear improvements in data availability, completeness, quality and timeliness. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 20 August 2007. BACKGROUND For more information, see: Migration and migrant population statistics (Eurostat) Asylum and managed migration statistics (Eurostat). KEY TERMS Emigration: the action by which a person, having previously been resident in an EU country, changes his or her country of residence for a period that is or is expected to be of at least 12 months. Immigration: the action by which a person establishes his or her residence in the territory of another EU or non-EU country for a period that is or is expected to be of at least 12 months. Irregular migration: the movement of people across borders that does not conform to the administrative or legal norms of the sending, transit or receiving country. Resettlement: the transfer of non-EU country citizens to an EU country where they are permitted to reside for the purposes of international protection. MAIN DOCUMENT Regulation (EC) No 862/2007 of the European Parliament and of the Council of 11 July 2007 on Community statistics on migration and international protection and repealing Council Regulation (EEC) No 311/76 on the compilation of statistics on foreign workers (OJ L 199, 31.7.2007, pp. 23-29) Successive amendments to Regulation (EU) No 862/2007 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Report from the Commission to the European Parliament and the Council on the implementation of Regulation (EC) No 862/2007 on Community statistics on migration and international protection (COM(2018) 594 final, 16.8.2018) Commission Regulation (EU) No 351/2010 of 23 April 2010 implementing Regulation (EC) No 862/2007 of the European Parliament and of the Council on Community statistics on migration and international protection as regards the definitions of the categories of the groups of country of birth, groups of country of previous usual residence, groups of country of next usual residence and groups of citizenship (OJ L 104, 24.4.2010, pp. 37-39) Commission Regulation (EU) No 216/2010 of 15 March 2010 implementing Regulation (EC) No 862/2007 of the European Parliament and of the Council on Community statistics on migration and international protection, as regards the definitions of categories of the reasons for the residence permits (OJ L 66, 16.3.2010, pp. 1-2) last update 24.08.2020"}
{"article": "27.5.2014 EN Official Journal of the European Union L 158/77 REGULATION (EU) No 537/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on specific requirements regarding statutory audit of public-interest entities and repealing Commission Decision 2005/909/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Statutory auditors and audit firms are entrusted by law to conduct statutory audits of public-interest entities with a view to enhancing the degree of confidence of the public in the annual and consolidated financial statements of such entities. The public-interest function of statutory audit means that a broad community of people and institutions rely on the quality of a statutory auditor's or an audit firm's work. Good audit quality contributes to the orderly functioning of markets by enhancing the integrity and efficiency of financial statements. Thus, statutory auditors fulfil a particularly important societal role. (2) Union legislation requires that the financial statements, comprising annual financial statements or consolidated financial statements, of credit institutions, insurance undertakings, issuers of securities admitted to trading on a regulated market, payment institutions, undertakings for collective investment in transferable securities (UCITS), electronic money institutions and alternative investment funds be audited by one or more persons entitled to carry out such audits in accordance with Union law, namely: Article 1(1) of Council Directive 86/635/EEC (3), Article 1(1) of Council Directive 91/674/EEC (4), Article 4(4) of Directive 2004/109/EC of the European Parliament and of the Council (5), Article 15(2) of Directive 2007/64/EC of the European Parliament and of the Council (6), Article 73 of Directive 2009/65/EC of the European Parliament and of the Council (7), Article 3(1) of Directive 2009/110/EC of the European Parliament and of the Council (8), and Article 22(3) of Directive 2011/61/EU of the European Parliament and of the Council (9). Moreover, point (1) of Article 4(1) of Directive 2004/39/EC of the European Parliament and of the Council (10) also requires that the annual financial statements of investment firms be audited when Directive 2013/34/EU of the European Parliament and of the Council (11) is not applicable. (3) The conditions for the approval of the persons responsible for carrying out the statutory audit as well as the minimum requirements for carrying out such statutory audit are laid down in Directive 2006/43/EC of the European Parliament and of the Council (12). (4) On 13 October 2010 the Commission published a Green Paper entitled \u2018Audit Policy: Lessons from the Crisis\u2019, which launched a wide public consultation, in the general context of financial market regulatory reform, on the role and scope of audit and how the audit function could be enhanced in order to contribute to increased financial stability. That public consultation showed that the rules of Directive 2006/43/EC regarding the carrying out of the statutory audit of annual and consolidated financial statements of public-interest entities could be improved. The European Parliament issued an own-initiative report on the Green Paper on 13 September 2011. The European Economic and Social Committee also adopted a report on that Green Paper on 16 June 2011. (5) It is important to lay down detailed rules with a view to ensuring that the statutory audits of public-interest entities are of adequate quality and are carried out by statutory auditors and audit firms subject to stringent requirements. A common regulatory approach should enhance the integrity, independence, objectivity, responsibility, transparency and reliability of statutory auditors and audit firms carrying out statutory audits of public-interest entities, contributing to the quality of statutory audits in the Union, thus to the smooth functioning of the internal market, while achieving a high level of consumer and investor protection. The development of a separate act for public-interest entities should also ensure consistent harmonisation and uniform application of the rules and thus contribute to a more effective functioning of the internal market. These strict requirements should be applicable to statutory auditors and audit firms only insofar as they carry out statutory audits of public-interest entities. (6) The statutory audit of cooperatives and savings banks is characterised in some Member States by a system that does not allow them to choose their statutory auditor or audit firm freely. The audit association to which the cooperative or savings bank belongs as a member is obliged by law to carry out the statutory audit. Such audit associations act on a non-profit-making basis without pursuing commercial interests, as results from their legal nature. In addition, the organisational units of these associations are not associated with a common economic interest, which could jeopardise their independence. Accordingly, Member States should have the possibility to exempt cooperatives within the meaning of point (14) of Article 2 of Directive 2006/43/EC, savings banks or similar entities as referred to in Article 45 of Directive 86/635/EEC or their subsidiaries or legal successors from this Regulation provided that the principles of independence laid down in Directive 2006/43/EC are complied with. (7) The level of fees received from one audited entity and the structure of fees can threaten the independence of a statutory auditor or an audit firm. Thus, it is important to ensure that audit fees are not based on any form of contingency and that, when the audit fees from a single client including its subsidiaries are significant, a specific procedure involving the audit committee is established to secure the quality of the audit. If the statutory auditor or the audit firm becomes excessively dependent on a single client, the audit committee should decide on the basis of proper grounds whether the statutory auditor or the audit firm may continue to carry out the statutory audit. When taking such decision, the audit committee should take into consideration, inter alia, the threats to independence and the consequences of such decision. (8) The provision of certain services other than statutory audit (non-audit services) to audited entities by statutory auditors, audit firms or members of their networks may compromise their independence. Therefore, it is appropriate to prohibit the provision of certain non-audit services such as specific tax, consultancy and advisory services to the audited entity, to its parent undertaking and to its controlled undertakings within the Union. The services that involve playing any part in the management or decision-making of the audited entity might include working capital management, providing financial information, business process optimisation, cash management, transfer pricing, creating supply chain efficiency and the like. Services linked to the financing, capital structure and allocation, and investment strategy of the audited entity should be prohibited except the provision of services such as due diligence services, issuing comfort letters in connection with prospectuses issued by the audited entity and other assurance services. (9) It should be possible for Member States to decide to allow the statutory auditors and the audit firms to provide certain tax and valuation services when such services are immaterial or have no direct effect, separately or in the aggregate, on the audited financial statements. Where such services involve aggressive tax planning, they should not be considered as immaterial. Accordingly, a statutory auditor or an audit firm should not provide such services to the audited entity. A statutory auditor or an audit firm should be able to provide non-audit services which are not prohibited under this Regulation, if the provision of those services has been approved in advance by the audit committee and if the statutory auditor or the audit firm has satisfied itself that provision of those services does not pose a threat to the independence of the statutory auditor or the audit firm that cannot be reduced to an acceptable level by the application of safeguards. (10) With a view to avoiding conflicts of interest it is important that the statutory auditor or the audit firm, before accepting or continuing an engagement for a statutory audit of a public-interest entity, assess whether the independence requirements are met, and in particular whether any threats to independence arise as a result of the relationship with that entity. The statutory auditor or the audit firm should confirm its independence annually to the audit committee of the audited entity and should discuss with that committee any threat to its independence as well as the safeguards applied to mitigate those threats. (11) Directive 95/46/EC of the European Parliament and of the Council (13) should govern the processing of personal data carried out in the Member States in the context of this Regulation and such processing of personal data should be subject to the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States. Any exchange or transmission of information by competent authorities should comply with the rules on the transfer of personal data as laid down in Directive 95/46/EC. (12) A sound engagement quality control review of the work carried out in each statutory audit engagement should be conducive to high audit quality. Therefore, the statutory auditor or the audit firm should not issue his, her or its audit report until such an engagement quality control review has been completed. (13) The results of the statutory audit of a public-interest entity should be presented to the stakeholders in the audit report. In order to increase the confidence of stakeholders in the financial statements of the audited entity, it is particularly important that the audit report be well-founded and solidly substantiated. In addition to the information required to be provided under Article 28 of Directive 2006/43/EC, the audit report should in particular include sufficient information on the independence of the statutory auditor or the audit firm and on whether the statutory audit was considered capable of detecting irregularities, including fraud. (14) The value of statutory audit for the audited entity would be particularly enhanced if the communication between the statutory auditor or the audit firm, on the one hand, and the audit committee, on the other hand, were reinforced. Further to the regular dialogue during the carrying out of the statutory audit, it is important that the statutory auditor or the audit firm submit to the audit committee an additional and more detailed report on the results of the statutory audit. This additional report should be submitted to the audit committee no later than the audit report. Upon request, the statutory auditor or the audit firm should discuss key matters which have been mentioned in the additional report with the audit committee. In addition, it should be possible to make such additional detailed report available to competent authorities responsible for the oversight of statutory auditors and audit firms upon their request, and to third parties where national law so provides. (15) Statutory auditors or audit firms already provide competent authorities supervising public-interest entities with information on facts or decisions which could constitute a breach of the rules governing the activities of the audited entity or an impairment of the continuous functioning of the audited entity. However, supervisory tasks would be facilitated if supervisors of credit institutions and insurance undertakings and their statutory auditors and audit firms were required to establish an effective dialogue with each other. (16) Regulation (EU) No 1092/2010 of the European Parliament and of the Council (14) established the European Systemic Risk Board (ESRB). The role of the ESRB is to monitor the build-up of systemic risk in the Union. Given the information that statutory auditors and audit firms of systemically important financial institutions have access to, their experience could help the ESRB in its work. Therefore an annual forum for dialogue between statutory auditors and audit firms, on the one hand, and ESRB, on the other, on a sectoral, anonymised basis should be facilitated by this Regulation. (17) In order to increase the confidence in, and the liability of, the statutory auditors and the audit firms carrying out the statutory audit of public-interest entities, it is important that the transparency reporting by statutory auditors and audit firms be increased. Therefore, statutory auditors and audit firms should be required to disclose financial information, showing in particular their total turnover divided into audit fees paid by public-interest entities, audit fees paid by other entities and fees for other services. They should also disclose financial information at the level of the network to which they belong. Statutory auditors and audit firms should provide additional supplementary information on audit fees to competent authorities with a view to facilitating their supervisory tasks. (18) It is important that the role of the audit committee in the selection of a new statutory auditor or audit firm be reinforced, in the interest of a more informed decision of the general meeting of shareholders or members of the audited entity. Hence, when making a proposal to the general meeting, the administrative or supervisory body should explain whether it follows the preference of the audit committee and, if not, why. The recommendation of the audit committee should include at least two possible choices for the audit engagement and a duly justified preference for one of them, so that a real choice can be made. In order to provide a fair and proper justification in its recommendation, the audit committee should use the results of a mandatory selection procedure organised by the audited entity, under the responsibility of the audit committee. In such selection procedure, the audited entity should not restrict statutory auditors or audit firms with a low market share from presenting proposals for the audit engagement. Tender documents should contain transparent and non-discriminatory selection criteria to be used for the evaluation of proposals. Considering, however, that this selection procedure could entail disproportionate costs for undertakings with reduced market capitalisation or small and medium-sized public-interest entities having regard to their size, it is appropriate to relieve such undertakings and entities from the obligation of organising a procedure for the selection of a new statutory auditor or audit firm. (19) The right of the general meeting of shareholders or members of the audited entity to choose the statutory auditor or the audit firm would be of no value if the audited entity were to enter into a contract with a third party providing for a restriction of such choice. Therefore, any clause of a contract entered into by the audited entity with a third party regarding the appointment or restricting the choice to particular statutory auditors or audit firms should be considered null and void. (20) The appointment of more than one statutory auditor or audit firm by public-interest entities would reinforce the professional scepticism and help to increase audit quality. Also, this measure, combined with the presence of smaller audit firms in the audit market would facilitate the development of the capacity of such firms, thus broadening the choice of statutory auditors and audit firms for public-interest entities. Therefore, the latter should be encouraged and incentivised to appoint more than one statutory auditor or audit firm to carry out the statutory audit. (21) In order to address the familiarity threat and therefore reinforce the independence of statutory auditors and audit firms, it is important to establish a maximum duration of the audit engagement of a statutory auditor or an audit firm in a particular audited entity. In addition, as a means of strengthening the independence of the statutory auditor or the audit firm, reinforcing professional scepticism, and increasing audit quality, this Regulation provides for the following alternatives for an extension of the maximum duration: regular and open mandatory retendering or the appointment of more than one statutory auditor or audit firm by public-interest entities. Also, the involvement of smaller audit firms in these measures would facilitate the development of the capacity of such firms, thus broadening the choice of statutory auditors and audit firms for public-interest entities. An appropriate gradual rotation mechanism should also be established with regard to the key audit partners carrying out the statutory audit on behalf of the audit firm. It is also important to provide for an appropriate period within which such statutory auditor or audit firm may not carry out the statutory audit of the same entity. In order to ensure a smooth transition, the former statutory auditor should transfer a handover file with relevant information to the incoming statutory auditor. (22) In order to ensure a high level of investor and consumer confidence in the internal market by avoiding conflicts of interests, statutory auditors and audit firms should be subject to appropriate oversight by competent authorities which are independent from the audit profession and which have adequate capacity, expertise and resources. Member States should be able to delegate or allow their competent authorities to delegate any of the tasks of those competent authorities to other authorities or bodies except those related to the quality assurance system, investigations and disciplinary systems. However, Member States should be able to choose to delegate tasks related to disciplinary systems to other authorities and bodies provided that the majority of the persons involved in the governance of the authority or body concerned are independent from the audit profession. The national competent authorities should have the necessary powers to undertake their supervisory tasks, including the capacity to access data, obtain information and carry out inspections. They should specialise in the supervision of financial markets, in the compliance with financial reporting obligations or in statutory audit oversight. However, it should be possible for the supervision of the compliance with the obligations imposed on public-interest entities to be carried out by the competent authorities responsible for the supervision of those entities. The funding of the competent authorities should be free from any undue influence by statutory auditors or audit firms. (23) The quality of supervision should improve if there is effective cooperation between authorities charged with different tasks at national level. Therefore, the authorities competent to supervise compliance with the obligations regarding statutory audit of public-interest entities should cooperate with the authorities responsible for the tasks provided for in Directive 2006/43/EC, with those supervising public-interest entities and with the financial intelligence units referred to in Directive 2005/60/EC of the European Parliament and of the Council (15). (24) External quality assurance for the statutory audit is fundamental for high quality audit. It adds credibility to published financial information and provides better protection for shareholders, investors, creditors and other interested parties. Statutory auditors and audit firms should therefore be subject to a system of quality assurance under the responsibility of the competent authorities, thus ensuring objectivity and independence from the audit profession. Quality assurance reviews should be organised in such a manner that each statutory auditor or each audit firm carrying out audits of public-interest entities is subject to a quality assurance review on the basis of an analysis of the risks. In the case of statutory auditors and audit firms carrying out statutory audits of public-interest entities other than those defined in points (17) and (18) of Article 2 of Directive 2006/43/EC, that review should take place at least every three years and, in other cases, at least every six years. The Commission Recommendation of 6 May 2008 on external quality assurance for statutory auditors and audit firms auditing public-interest entities (16) provides information on how inspections should be undertaken. Quality assurance reviews should be appropriate and proportionate in view of the scale and complexity of the business of the reviewed statutory auditor or audit firm. (25) The market for the provision of statutory audit services to public-interest entities evolves over time. It is therefore necessary that competent authorities monitor the developments in the market, particularly as regards the risks that arise from high market concentration, including within specific sectors, and the performance of audit committees. (26) The transparency of the activities of competent authorities should help to increase the confidence of investors and consumers in the internal market. Therefore, competent authorities should be required to report regularly on their activities and to publish information in aggregated form on findings and conclusions of inspections, or in individual form where Member States so provide. (27) Cooperation between the competent authorities of the Member States can make an important contribution to ensuring consistently high quality of statutory audit in the Union. Therefore, the competent authorities of the Member States should cooperate with each other, where necessary, for the purpose of carrying out their supervisory duties regarding statutory audits. They should respect the principle of home-country regulation and oversight by the Member State in which the statutory auditor or the audit firm is approved and in which the audited entity has its registered office. The cooperation between competent authorities should be organised within the framework of a Committee of European Auditing Oversight Bodies (CEAOB), which should be composed of high-level representatives of the competent authorities. In order to enhance consistent application of this Regulation, the CEAOB should be able to adopt non-binding guidelines or opinions. In addition, it should facilitate the exchange of information, provide advice to the Commission and contribute to technical assessments and technical examinations. For the purpose of carrying out the technical assessment of public oversight systems of third countries and to the international cooperation between Member States and third countries in this area, the CEAOB should establish a sub-group chaired by the member appointed by the European Supervisory Authority (European Securities and Markets Authority \u2014 ESMA) (17) and should request the assistance from ESMA, the European Supervisory Authority (European Banking Authority \u2014 EBA) (18) or the European Supervisory Authority (European Insurance and Occupational Pensions Authority \u2014 EIOPA) (19) insofar as its request is related to the international cooperation between Member States and third countries in the field of statutory audit of public-interest entities supervised by these European Supervisory Authorities. The Secretariat of the CEAOB should be provided by the Commission and, based on the work programme agreed by the CEAOB, should include related expenses in its estimates for the next year. (28) The scope of cooperation between the competent authorities of Member States should include cooperation with regard to quality assurance reviews and assistance with investigations related to the carrying-out of statutory audits of public-interest entities, including in cases where the conduct under investigation does not constitute an infringement of any legislative or regulatory provision in force in the Member States concerned. The detailed arrangements for cooperation between the competent authorities of the Member States should include the possibility of creating colleges of competent authorities and the delegation of tasks among themselves. The concept of a network in which statutory auditors and audit firms operate should be taken into account in such cooperation. Competent authorities should respect appropriate confidentiality and professional secrecy rules. (29) The interrelation of capital markets gives rise to the need to empower competent authorities to cooperate with supervisory authorities and bodies of third countries regarding the exchange of information or quality assurance reviews. However, where the cooperation with third country authorities is related to audit working papers or other documents held by statutory auditors or audit firms, the procedures laid down by Directive 2006/43/EC should apply. (30) Sustainable audit capacity and a competitive market for statutory audit services in which there is a sufficient choice of statutory auditors and audit firms capable of carrying out statutory audits of public-interest entities are required in order to ensure a smooth functioning of capital markets. The competent authorities and the European Competition Network (ECN) should report on the changes brought in the audit market structure introduced by this Regulation. (31) The alignment of the procedures for the adoption of delegated acts by the Commission to the Treaty on the Functioning of the European Union and, in particular, to Article 290 and 291 thereof, should be effected on a case-by-case basis. In order to take into account the developments in auditing and in the audit profession, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. In particular, delegated acts are necessary for the purpose of adopting international auditing standards in the area of audit practice, independence of and internal controls of statutory auditors and audit firms. The international auditing standards adopted should not amend any requirements of this Regulation or supplement any of those requirements, except for those precisely defined. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including consultations at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (32) In order to ensure legal certainty and the smooth transition to the regime introduced by this Regulation, it is important to introduce a transitional period regarding the entry into force of the obligation to rotate statutory auditors and audit firms and the obligation to organise a selection procedure for the choice of statutory auditors and audit firms. (33) References to provisions of Directive 2006/43/EC should be understood as references to the national provisions transposing those provisions of Directive 2006/43/EC. The new European audit framework as established by this Regulation and Directive 2014/56/EU of the European Parliament and of the Council (20) replaces existing requirements laid down in Directive 2006/43/EC and should be interpreted without referring to any preceding instruments such as Commission recommendations adopted under the previous framework. (34) Since the objectives of this Regulation, namely clarifying and better defining the role of statutory audit regarding public-interest entities, improving the information that the statutory auditor or the audit firm provides to the audited entity, investors and other stakeholders, improving the communication channels between auditors and supervisors of public-interest entities, preventing any conflict of interest arising from the provision of non-audit services to public-interest entities, mitigating the risk of any potential conflict of interest due to the existing system whereby the auditee selects and pays the auditor or the familiarity threat, facilitating the switching of, and the choice of a statutory auditor or an audit firm to public-interest entities, broadening the choice of statutory auditors and audit firms for public-interest entities and improving the effectiveness, independence and consistency of the regulation and oversight of statutory auditors and audit firms providing statutory audits to public-interest entities including as regards cooperation at Union level, cannot be sufficiently achieved by the Member States but can rather, by reason of their scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (35) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, notably the right to respect for private and family life, the right to the protection of personal data, and the freedom to conduct a business, and has to be applied in accordance with those rights and principles. (36) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council and delivered an opinion on 23 April 2012 (21). (37) A new legal framework of statutory audit of annual and consolidated financial statements should be established by this Regulation and Directive 2014/56/EU, therefore Commission Decision 2005/909/EC (22) should be repealed, HAVE ADOPTED THIS REGULATION: TITLE I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter This Regulation lays down requirements for the carrying out of the statutory audit of annual and consolidated financial statements of public-interest entities, rules on the organisation and selection of statutory auditors and audit firms by public-interest entities to promote their independence and the avoidance of conflicts of interest and rules on the supervision of compliance by statutory auditors and audit firms with those requirements. Article 2 Scope 1. This Regulation shall apply to the following: (a) statutory auditors and audit firms carrying out statutory audits of public-interest entities; (b) public-interest entities. 2. This Regulation shall apply without prejudice to Directive 2006/43/EC. 3. Where a cooperative within the meaning of point (14) of Article 2 of Directive 2006/43/EC, a savings bank or a similar entity as referred to in Article 45 of Directive 86/635/EEC, or a subsidiary or a legal successor of a cooperative, a savings bank or a similar entity as referred to in Article 45 of Directive 86/635/EEC is required or permitted under national provisions to be a member of a non-profit-making auditing entity, the Member State may decide that this Regulation or certain provisions of it shall not apply to the statutory audit of such entity, provided that the principles of independence laid down in Directive 2006/43/EC are complied with by the statutory auditor when carrying out the statutory audit of one of its members and by persons who may be in a position to influence the statutory audit. 4. Where a cooperative within the meaning of point (14) of Article 2 of Directive 2006/43/EC, a savings bank or a similar entity as referred to in Article 45 of Directive 86/635/EEC, or a subsidiary or a legal successor of a cooperative, a savings bank or a similar entity as referred to in Article 45 of Directive 86/635/EEC is required or permitted under national provisions to be a member of a non-profit-making auditing entity, an objective, reasonable and informed party would not conclude that the membership-based relationship compromises the statutory auditor's independence, provided that when such an auditing entity is conducting a statutory audit of one of its members, the principles of independence are applied to the statutory auditors carrying out the audit and those persons who may be in a position to influence the statutory audit. 5. The Member State shall inform the Commission and the Committee of European Auditing Oversight Bodies (hereinafter referred to as \u2018the CEAOB\u2019), referred to in Article 30, of such exceptional situations of non-application of this Regulation or certain provisions of this Regulation. It shall communicate to the Commission and the CEAOB the list of provisions of this Regulation that do not apply to the statutory audit of the entities referred to in paragraph 3 of this Article and the reasons that justified such non-application. Article 3 Definitions For the purposes of this Regulation, the definitions laid down in Article 2 of Directive 2006/43/EC shall apply, except as regards the term \u2018competent authority\u2019 as provided for in Article 20 of this Regulation. TITLE II CONDITIONS FOR CARRYING OUT STATUTORY AUDIT OF PUBLIC INTEREST ENTITIES Article 4 Audit fees 1. Fees for the provision of statutory audits to public-interest entities shall not be contingent fees. Without prejudice to Article 25 of Directive 2006/43/EC, for the purposes of the first subparagraph, contingent fees means fees for audit engagements calculated on a predetermined basis relating to the outcome or result of a transaction or the result of the work performed. Fees shall not be regarded as being contingent if a court or a competent authority has established them. 2. When the statutory auditor or the audit firm provides to the audited entity, its parent undertaking or its controlled undertakings, for a period of three or more consecutive financial years, non-audit services other than those referred to in Article 5(1) of this Regulation, the total fees for such services shall be limited to no more than 70 % of the average of the fees paid in the last three consecutive financial years for the statutory audit(s) of the audited entity and, where applicable, of its parent undertaking, of its controlled undertakings and of the consolidated financial statements of that group of undertakings. For the purposes of the limits specified in the first subparagraph, non-audit services, other than those referred to in Article 5(1), required by Union or national legislation shall be excluded. Member States may provide that a competent authority may, upon a request by the statutory auditor or the audit firm, on an exceptional basis, allow that statutory auditor or audit firm to be exempt from the requirements in the first subparagraph in respect of an audited entity for a period not exceeding two financial years. 3. When the total fees received from a public-interest entity in each of the last three consecutive financial years are more than 15 % of the total fees received by the statutory auditor or the audit firm or, where applicable, by the group auditor carrying out the statutory audit, in each of those financial years, such a statutory auditor or audit firm or, as the case may be, group auditor, shall disclose that fact to the audit committee and discuss with the audit committee the threats to their independence and the safeguards applied to mitigate those threats. The audit committee shall consider whether the audit engagement should be subject to an engagement quality control review by another statutory auditor or audit firm prior to the issuance of the audit report. Where the fees received from such a public-interest entity continue to exceed 15 % of the total fees received by such a statutory auditor or audit firm or, as the case may be, by a group auditor carrying out the statutory audit, the audit committee shall decide on the basis of objective grounds whether the statutory auditor or the audit firm or the group auditor, of such an entity or group of entities may continue to carry out the statutory audit for an additional period which shall not, in any case, exceed two years. 4. Member States may apply more stringent requirements than set out in this Article. Article 5 Prohibition of the provision of non-audit services 1. A statutory auditor or an audit firm carrying out the statutory audit of a public-interest entity, or any member of the network to which the statutory auditor or the audit firm belongs, shall not directly or indirectly provide to the audited entity, to its parent undertaking or to its controlled undertakings within the Union any prohibited non-audit services in: (a) the period between the beginning of the period audited and the issuing of the audit report; and (b) the financial year immediately preceding the period referred to in point (a) in relation to the services listed in point (g) of the second subparagraph. For the purposes of this Article, prohibited non-audit services shall mean: (a) tax services relating to: (i) preparation of tax forms; (ii) payroll tax; (iii) customs duties; (iv) identification of public subsidies and tax incentives unless support from the statutory auditor or the audit firm in respect of such services is required by law; (v) support regarding tax inspections by tax authorities unless support from the statutory auditor or the audit firm in respect of such inspections is required by law; (vi) calculation of direct and indirect tax and deferred tax; (vii) provision of tax advice; (b) services that involve playing any part in the management or decision-making of the audited entity; (c) bookkeeping and preparing accounting records and financial statements; (d) payroll services; (e) designing and implementing internal control or risk management procedures related to the preparation and/or control of financial information or designing and implementing financial information technology systems; (f) valuation services, including valuations performed in connection with actuarial services or litigation support services; (g) legal services, with respect to: (i) the provision of general counsel; (ii) negotiating on behalf of the audited entity; and (iii) acting in an advocacy role in the resolution of litigation; (h) services related to the audited entity's internal audit function; (i) services linked to the financing, capital structure and allocation, and investment strategy of the audited entity, except providing assurance services in relation to the financial statements, such as the issuing of comfort letters in connection with prospectuses issued by the audited entity; (j) promoting, dealing in, or underwriting shares in the audited entity; (k) human resources services, with respect to: (i) management in a position to exert significant influence over the preparation of the accounting records or financial statements which are the subject of the statutory audit, where such services involve: \u2014 searching for or seeking out candidates for such position; or \u2014 undertaking reference checks of candidates for such positions; (ii) structuring the organisation design; and (iii) cost control. 2. Member States may prohibit services other than those listed in paragraph 1 where they consider that those services represent a threat to independence. Member States shall communicate to the Commission any additions to the list in paragraph 1. 3. By way of derogation from the second subparagraph of paragraph 1, Member States may allow the provision of the services referred to in points (a) (i), (a) (iv) to (a) (vii) and (f), provided that the following requirements are complied with: (a) they have no direct or have immaterial effect, separately or in the aggregate on the audited financial statements; (b) the estimation of the effect on the audited financial statements is comprehensively documented and explained in the additional report to the audit committee referred to in Article 11; and (c) the principles of independence laid down in Directive 2006/43/EC are complied with by the statutory auditor or the audit firm. 4. A statutory auditor or an audit firm carrying out statutory audits of public-interest entities and, where the statutory auditor or the audit firm belongs to a network, any member of such network, may provide to the audited entity, to its parent undertaking or to its controlled undertakings non-audit services other than the prohibited non-audit services referred to in paragraphs 1 and 2 subject to the approval of the audit committee after it has properly assessed threats to independence and the safeguards applied in accordance with Article 22b of Directive 2006/43/EC. The audit committee shall, where applicable, issue guidelines with regard to the services referred to in paragraph 3. Member States may establish stricter rules setting out the conditions under which a statutory auditor, an audit firm or a member of a network to which the statutory auditor or audit firm belongs may provide to the audited entity, to its parent undertaking or to its controlled undertakings non-audit services other than the prohibited non-audit services referred to in paragraph 1. 5. When a member of a network to which the statutory auditor or the audit firm carrying out a statutory audit of a public-interest entity belongs provides any of the non-audit services, referred to in paragraphs 1 and 2 of this Article, to an undertaking incorporated in a third country which is controlled by the audited public-interest entity, the statutory auditor or the audit firm concerned shall assess whether his, her or its independence would be compromised by such provision of services by the member of the network. If his, her or its independence is affected, the statutory auditor or the audit firm shall apply safeguards where applicable in order to mitigate the threats caused by such provision of services in a third country. The statutory auditor or the audit firm may continue to carry out the statutory audit of the public-interest entity only if he, she or it can justify, in accordance with Article 6 of this Regulation and Article 22b of Directive 2006/43/EC, that such provision of services does not affect his, her or its professional judgement and the audit report. For the purposes of this paragraph: (a) being involved in the decision-taking of the audited entity and the provision of the services referred to in points (b), (c) and (e) of the second subparagraph of paragraph 1 shall be deemed to affect such independence in all cases and to be incapable of mitigation by any safeguards. (b) provision of the services referred to in the second subparagraph of paragraph 1 other than points (b), (c) and (e) thereof shall be deemed to affect such independence and therefore to require safeguards to mitigate the threats caused thereby. Article 6 Preparation for the statutory audit and assessment of threats to independence 1. Before accepting or continuing an engagement for a statutory audit of a public- interest entity, a statutory auditor or an audit firm shall assess and document, in addition to the provisions of Article 22b of Directive 2006/43/EC, the following: (a) whether he, she or it complies with the requirements of Articles 4 and 5 of this Regulation; (b) whether the conditions of Article 17 of this Regulation are complied with; (c) without prejudice to Directive 2005/60/EC, the integrity of the members of the supervisory, administrative and management bodies of the public-interest entity. 2. A statutory auditor or an audit firm shall: (a) confirm annually in writing to the audit committee that the statutory auditor, the audit firm and partners, senior managers and managers, conducting the statutory audit are independent from the audited entity; (b) discuss with the audit committee the threats to their independence and the safeguards applied to mitigate those threats, as documented by them pursuant to paragraph 1. Article 7 Irregularities Without prejudice to Article 12 of this Regulation and Directive 2005/60/EC, when a statutory auditor or an audit firm carrying out the statutory audit of a public-interest entity suspects or has reasonable grounds to suspect that irregularities, including fraud with regard to the financial statements of the audited entity, may occur or have occurred, he, she or it shall inform the audited entity and invite it to investigate the matter and take appropriate measures to deal with such irregularities and to prevent any recurrence of such irregularities in the future. Where the audited entity does not investigate the matter, the statutory auditor or the audit firm shall inform the authorities as designated by the Member States responsible for investigating such irregularities. The disclosure in good faith to those authorities, by the statutory auditor or the audit firm, of any irregularities referred to in the first subparagraph shall not constitute a breach of any contractual or legal restriction on disclosure of information. Article 8 Engagement quality control review 1. Before the reports referred to in Articles 10 and 11 are issued, an engagement quality control review (in this Article hereinafter referred to as: review) shall be performed to assess whether the statutory auditor or the key audit partner could reasonably have come to the opinion and conclusions expressed in the draft of these reports. 2. The review shall be performed by an engagement quality control reviewer (in this Article hereinafter referred to as: reviewer). The reviewer shall be a statutory auditor who is not involved in the performance of the statutory audit to which the review relates. 3. By way of derogation from paragraph 2, where the statutory audit is carried out by an audit firm and all the statutory auditors were involved in the carrying-out of the statutory audit, or where the statutory audit is carried out by a statutory auditor and the statutory auditor is not a partner or employee of an audit firm, he, she or it shall arrange for another statutory auditor to perform a review. The disclosure of documents or information to the independent reviewer for the purposes of this Article shall not constitute a breach of professional secrecy. Documents or information disclosed to the reviewer for the purposes of this Article shall be subject to professional secrecy. 4. When performing the review, the reviewer shall record at least the following: (a) the oral and written information provided by the statutory auditor or the key audit partner to support the significant judgements as well as the main findings of the audit procedures carried out and the conclusions drawn from those findings, whether or not at the request of the reviewer; (b) the opinions of the statutory auditor or the key audit partner, as expressed in the draft of the reports referred to in Articles 10 and 11; 5. The review shall at least assess the following elements: (a) the independence of the statutory auditor or the audit firm from the audited entity; (b) the significant risks which are relevant to the statutory audit and which the statutory auditor or the key audit partner has identified during the performance of the statutory audit and the measures that he or she has taken to adequately manage those risks; (c) the reasoning of the statutory auditor or the key audit partner, in particular with regard to the level of materiality and the significant risks referred to in point (b); (d) any request for advice to external experts and the implementation of such advice; (e) the nature and scope of the corrected and uncorrected misstatements in the financial statements that were identified during the carrying out of the audit; (f) the subjects discussed with the audit committee and the management and/or supervisory bodies of the audited entity; (g) the subjects discussed with competent authorities and, where applicable, with other third parties; (h) whether the documents and information selected from the file by the reviewer support the opinion of the statutory auditor or the key audit partner as expressed in the draft of the reports referred to in Articles 10 and 11. 6. The reviewer shall discuss the results of the review with the statutory auditor or the key audit partner. The audit firm shall establish procedures for determining the manner in which any disagreement between the key audit partner and the reviewer are to be resolved. 7. The statutory auditor or the audit firm and the reviewer shall keep a record of the results of the review, together with the considerations underlying those results. Article 9 International auditing standards The Commission shall be empowered to adopt by means of delegated acts in accordance with Article 39 the international auditing standards referred to in Article 26 of Directive 2006/43/EC in the area of audit practice, and the independence and internal quality controls of statutory auditors and audit firms for the purposes of their application within the Union, provided they meet the requirements of points (a), (b) and (c) of Article 26(3) of Directive 2006/43/EC and do not amend any of the requirements of this Regulation or supplement any of its requirements apart from those set out in Articles 7, 8 and 18 of this Regulation. Article 10 Audit report 1. The statutory auditor(s) or the audit firm(s) shall present the results of the statutory audit of the public-interest entity in an audit report. 2. The audit report shall be prepared in accordance with the provisions of Article 28 of Directive 2006/43/EC and in addition shall at least: (a) state by whom or by which body the statutory auditor(s) or the audit firm(s) was (were) appointed; (b) indicate the date of the appointment and the period of total uninterrupted engagement including previous renewals and reappointments of the statutory auditors or the audit firms; (c) provide, in support of the audit opinion, the following: (i) a description of the most significant assessed risks of material misstatement, including assessed risks of material misstatement due to fraud; (ii) a summary of the auditor's response to those risks; and (iii) where relevant, key observations arising with respect to those risks. Where relevant to the above information provided in the audit report concerning each significant assessed risk of material misstatement, the audit report shall include a clear reference to the relevant disclosures in the financial statements. (d) explain to what extent the statutory audit was considered capable of detecting irregularities, including fraud; (e) confirm that the audit opinion is consistent with the additional report to the audit committee referred to in Article 11; (f) declare that the prohibited non-audit services referred to in Article 5(1) were not provided and that the statutory auditor(s) or the audit firm(s) remained independent of the audited entity in conducting the audit; (g) indicate any services, in addition to the statutory audit, which were provided by the statutory auditor or the audit firm to the audited entity and its controlled undertaking(s), and which have not been disclosed in the management report or financial statements. Member States may lay down additional requirements in relation to the content of the audit report. 3. Except as required by point (e) of paragraph 2 the audit report shall not contain any cross-references to the additional report to the audit committee referred to in Article 11. The audit report shall be in clear and unambiguous language. 4. The statutory auditor or the audit firm shall not use the name of any competent authority in a way that would indicate or suggest endorsement or approval by that authority of the audit report. Article 11 Additional report to the audit committee 1. Statutory auditors or audit firms carrying out statutory audits of public-interest entities shall submit an additional report to the audit committee of the audited entity not later than the date of submission of the audit report referred to in Article 10. Member States may additionally require that this additional report be submitted to the administrative or supervisory body of the audited entity. If the audited entity does not have an audit committee, the additional report shall be submitted to the body performing equivalent functions within the audited entity. Member States may allow the audit committee to disclose that additional report to such third parties as are provided for in their national law. 2. The additional report to the audit committee shall be in writing. It shall explain the results of the statutory audit carried out and shall at least: (a) include the declaration of independence referred to in point (a) of Article 6(2); (b) where the statutory audit was carried out by an audit firm, the report shall identify each key audit partner involved in the audit; (c) where the statutory auditor or the audit firm has made arrangements for any of his, her or its activities to be conducted by another statutory auditor or audit firm that is not a member of the same network, or has used the work of external experts, the report shall indicate that fact and shall confirm that the statutory auditor or the audit firm received a confirmation from the other statutory auditor or audit firm and/or the external expert regarding their independence; (d) describe the nature, frequency and extent of communication with the audit committee or the body performing equivalent functions within the audited entity, the management body and the administrative or supervisory body of the audited entity, including the dates of meetings with those bodies; (e) include a description of the scope and timing of the audit; (f) where more than one statutory auditor or audit firm have been appointed, describe the distribution of tasks among the statutory auditors and/or the audit firms; (g) describe the methodology used, including which categories of the balance sheet have been directly verified and which categories have been verified based on system and compliance testing, including an explanation of any substantial variation in the weighting of system and compliance testing when compared to the previous year, even if the previous year's statutory audit was carried out by other statutory auditor(s) or audit firm(s); (h) disclose the quantitative level of materiality applied to perform the statutory audit for the financial statements as a whole and where applicable the materiality level or levels for particular classes of transactions, account balances or disclosures, and disclose the qualitative factors which were considered when setting the level of materiality; (i) report and explain judgements about events or conditions identified in the course of the audit that may cast significant doubt on the entity's ability to continue as a going concern and whether they constitute a material uncertainty, and provide a summary of all guarantees, comfort letters, undertakings of public intervention and other support measures that have been taken into account when making a going concern assessment; (j) report on any significant deficiencies in the audited entity's or, in the case of consolidated financial statements, the parent undertaking's internal financial control system, and/or in the accounting system. For each such significant deficiency, the additional report shall state whether or not the deficiency in question has been resolved by the management; (k) report any significant matters involving actual or suspected non-compliance with laws and regulations or articles of association which were identified in the course of the audit, in so far as they are considered to be relevant in order to enable the audit committee to fulfil its tasks; (l) report and assess the valuation methods applied to the various items in the annual or consolidated financial statements including any impact of changes of such methods; (m) in the case of a statutory audit of consolidated financial statements, explain the scope of consolidation and the exclusion criteria applied by the audited entity to the non-consolidated entities, if any, and whether those criteria applied are in accordance with the financial reporting framework; (n) where applicable, identify any audit work performed by third-country auditor(s), statutory auditor(s), third-country audit entity(ies) or audit firm(s) in relation to a statutory audit of consolidated financial statements other than by members of the same network as to which the auditor of the consolidated financial statements belongs; (o) indicate whether all requested explanations and documents were provided by the audited entity; (p) report: (i) any significant difficulties encountered in the course of the statutory audit; (ii) any significant matters arising from the statutory audit that were discussed or were the subject of correspondence with management; and (iii) any other matters arising from the statutory audit that in the auditor's professional judgement, are significant to the oversight of the financial reporting process. Member States may lay down additional requirements in relation to the content of the additional report to the audit committee. Upon request by a statutory auditor, an audit firm or the audit committee, the statutory auditor(s) or the audit firm(s) shall discuss key matters arising from the statutory audit, referred to in the additional report to the audit committee, and in particular in point (j) of the first subparagraph, with the audit committee, administrative body or, where applicable, supervisory body of the audited entity. 3. Where more than one statutory auditor or audit firm have been engaged simultaneously, and any disagreement has arisen between them on auditing procedures, accounting rules or any other issue regarding the conduct of the statutory audit, the reasons for such disagreement shall be explained in the additional report to the audit committee. 4. The additional report to the audit committee shall be signed and dated. Where an audit firm carries out the statutory audit, the additional report to the audit committee shall be signed by the statutory auditors carrying out the statutory audit on behalf of the audit firm. 5. Upon request, and in accordance with national law, the statutory auditors or the audit firms shall make available without delay the additional report to the competent authorities within the meaning of Article 20(1). Article 12 Report to supervisors of public-interest entities 1. Without prejudice to Article 55 of Directive 2004/39/EC, Article 63 of Directive 2013/36/EU of the European Parliament and of the Council (23), Article 15(4) of Directive 2007/64/EC, Article 106 of Directive 2009/65/EC, Article 3(1) of Directive 2009/110/EC and Article 72 of Directive 2009/138/EC of the European Parliament and of the Council (24), the statutory auditor or the audit firm carrying out the statutory audit of a public-interest entity shall have a duty to report promptly to the competent authorities supervising that public-interest entity or, where so determined by the Member State concerned, to the competent authority responsible for the oversight of the statutory auditor or audit firm, any information concerning that public-interest entity of which he, she or it has become aware while carrying out that statutory audit and which may bring about any of the following: (a) a material breach of the laws, regulations or administrative provisions which lay down, where appropriate, the conditions governing authorisation or which specifically govern pursuit of the activities of such public-interest entity; (b) a material threat or doubt concerning the continuous functioning of the public-interest entity; (c) a refusal to issue an audit opinion on the financial statements or the issuing of an adverse or qualified opinion. Statutory auditors or audit firms shall also have a duty to report any information referred to in points (a) (b) or (c) of the first subparagraph of which they become aware in the course of carrying out the statutory audit of an undertaking having close links with the public-interest entity for which they are also carrying out the statutory audit. For the purposes of this Article, \u2018close links\u2019 shall have the meaning assigned to that term in point (38) of Article 4(1) of Regulation (EU) No 575/2013 of the European Parliament and of the Council (25). Member States may require additional information from the statutory auditor or the audit firm provided it is necessary for effective financial market supervision as provided for in national law. 2. An effective dialogue shall be established between the competent authorities supervising credit institutions and insurance undertakings, on the one hand, and the statutory auditor(s) and the audit firm(s) carrying out the statutory audit of those institutions and undertakings, on the other hand. The responsibility for compliance with this requirement shall rest with both parties to the dialogue. At least once a year, the European Systemic Risk Board (ESRB) and the CEAOB shall organise a meeting with the statutory auditors and the audit firms or networks carrying out statutory audits of all global systemically important financial institutions authorised within the Union, as identified internationally, in order to inform the ESRB of sectoral or any significant developments in those systemically important financial institutions. In order to facilitate the exercise of the tasks referred to in the first subparagraph, the European Supervisory Authority (European Banking Authority \u2014 EBA) and the European Supervisory Authority (European Insurance and Occupational Pensions Authority \u2014 EIOPA) shall, taking current supervisory practices into account, issue guidelines addressed to the competent authorities supervising credit institutions and insurance undertakings, in accordance with Article 16 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (26) and Article 16 of Regulation (EU) No 1094/2010 of the European Parliament and of the Council (27), respectively. 3. The disclosure in good faith to the competent authorities or to ESRB and the CEAOB, by the statutory auditor or the audit firm or network, where applicable, of any information referred to in paragraph 1 or of any information emerging during the dialogue provided for in paragraph 2 shall not constitute a breach of any contractual or legal restriction on disclosure of information. Article 13 Transparency report 1. A statutory auditor or an audit firm that carries out statutory audits of public-interest entities shall make public an annual transparency report at the latest four months after the end of each financial year. That transparency report shall be published on the website of the statutory auditor or the audit firm and shall remain available on that website for at least five years from the day of its publication on the website. If the statutory auditor is employed by an audit firm, the obligations under this Article shall be incumbent on the audit firm. A statutory auditor or an audit firm shall be allowed to update its published annual transparency report. In such a case, the statutory auditor or the audit firm shall indicate that it is an updated version of the report and the original version of the report shall continue to remain available on the website. Statutory auditors and audit firms shall communicate to the competent authorities that the transparency report has been published on the website of the statutory auditor or the audit firm or, as appropriate, that it has been updated. 2. The annual transparency report shall include at least the following: (a) a description of the legal structure and ownership of the audit firm; (b) where the statutory auditor or the audit firm is a member of a network: (i) a description of the network and the legal and structural arrangements in the network; (ii) the name of each statutory auditor operating as a sole practitioner or audit firm that is a member of the network; (iii) the countries in which each statutory auditor operating as a sole practitioner or audit firm that is a member of the network is qualified as a statutory auditor or has his, her or its registered office, central administration or principal place of business; (iv) the total turnover achieved by the statutory auditors operating as sole practitioners and audit firms that are members of the network, resulting from the statutory audit of annual and consolidated financial statements; (c) a description of the governance structure of the audit firm; (d) a description of the internal quality control system of the statutory auditor or of the audit firm and a statement by the administrative or management body on the effectiveness of its functioning; (e) an indication of when the last quality assurance review referred to in Article 26 was carried out; (f) a list of public-interest entities for which the statutory auditor or the audit firm carried out statutory audits during the preceding financial year; (g) a statement concerning the statutory auditor's or the audit firm's independence practices which also confirms that an internal review of independence compliance has been conducted; (h) a statement on the policy followed by the statutory auditor or the audit firm concerning the continuing education of statutory auditors referred to in Article 13 of Directive 2006/43/EC; (i) information concerning the basis for the partners' remuneration in audit firms; (j) a description of the statutory auditor's or the audit firm's policy concerning the rotation of key audit partners and staff in accordance with Article 17(7); (k) where not disclosed in its financial statements within the meaning of Article 4(2) of Directive 2013/34/EU, information about the total turnover of the statutory auditor or the audit firm, divided into the following categories: (i) revenues from the statutory audit of annual and consolidated financial statements of public-interest entities and entities belonging to a group of undertakings whose parent undertaking is a public-interest entity; (ii) revenues from the statutory audit of annual and consolidated financial statements of other entities; (iii) revenues from permitted non-audit services to entities that are audited by the statutory auditor or the audit firm; and (iv) revenues from non-audit services to other entities. The statutory auditor or the audit firm may, in exceptional circumstances, decide not to disclose the information required in point (f) of the first subparagraph to the extent necessary to mitigate an imminent and significant threat to the personal security of any person. The statutory auditor or the audit firm shall be able to demonstrate to the competent authority the existence of such threat. 3. The transparency report shall be signed by the statutory auditor or the audit firm. Article 14 Information for competent authorities Statutory auditors and audit firms shall provide annually to his, her or its competent authority a list of the audited public-interest entities by revenue generated from them, dividing those revenues into: (a) revenues from statutory audit; (b) revenues from non-audit services other than those referred to in Article 5(1) which are required by Union or national legislation; and, (c) revenues from non-audit services other than those referred to in Article 5(1) which are not required by Union or national legislation. Article 15 Record keeping Statutory auditors and audit firms shall keep the documents and information referred to in Article 4(3), Article 6, Article 7, Article 8(4) to (7), Articles 10 and 11 Article 12(1) and (2), Article 14, Article 16(2), (3) and(5) of this Regulation, and in Articles 22b, 24a, 24b, 27 and 28 of Directive 2006/43/EC, for a period of at least five years following the creation of such documents or information. Member States may require statutory auditors and audit firms to keep the documents and information referred to in the first subparagraph for a longer period in accordance with their rules on personal data protection and administrative and judicial proceedings. TITLE III THE APPOINTMENT OF STATUTORY AUDITORS OR AUDIT FIRMS BY PUBLIC-INTEREST ENTITIES Article 16 Appointment of statutory auditors or audit firms 1. For the purposes of the application of Article 37(1) of Directive 2006/43/EC, for the appointment of statutory auditors or audit firms by public-interest entities, the conditions set out in paragraphs 2 to 5 of this Article shall apply, but may be subject to paragraph 7. Where Article 37(2) of Directive 2006/43/EC applies, the public-interest entity shall inform the competent authority of the use of the alternative systems or modalities referred to in that Article. In that event, paragraphs 2 to 5 of this Article shall not apply. 2. The audit committee shall submit a recommendation to the administrative or supervisory body of the audited entity for the appointment of statutory auditors or audit firms. Unless it concerns the renewal of an audit engagement in accordance with Article 17(1) and 17(2), the recommendation shall be justified and contain at least two choices for the audit engagement and the audit committee shall express a duly justified preference for one of them. In its recommendation, the audit committee shall state that its recommendation is free from influence by a third party and that no clause of the kind referred to in paragraph 6 has been imposed upon it. 3. Unless it concerns the renewal of an audit engagement in accordance with Article 17(1) and 17(2), the recommendation of the audit committee referred to in paragraph 2 of this Article shall be prepared following a selection procedure organised by the audited entity respecting the following criteria: (a) the audited entity shall be free to invite any statutory auditors or audit firms to submit proposals for the provision of the statutory audit service on the condition that Article 17(3) is respected and that the organisation of the tender process does not in any way preclude the participation in the selection procedure of firms which received less than 15 % of the total audit fees from public-interest entities in the Member State concerned in the previous calendar year; (b) the audited entity shall prepare tender documents for the attention of the invited statutory auditors or audit firms. Those tender documents shall allow them to understand the business of the audited entity and the type of statutory audit that is to be carried out. The tender documents shall contain transparent and non-discriminatory selection criteria that shall be used by the audited entity to evaluate the proposals made by statutory auditors or audit firms; (c) the audited entity shall be free to determine the selection procedure and may conduct direct negotiations with interested tenderers in the course of the procedure; (d) where, in accordance with Union or national law, the competent authorities referred to in Article 20 require statutory auditors and audit firms to comply with certain quality standards, those standards shall be included in the tender documents; (e) the audited entity shall evaluate the proposals made by the statutory auditors or the audit firms in accordance with the selection criteria predefined in the tender documents. The audited entity shall prepare a report on the conclusions of the selection procedure, which shall be validated by the audit committee. The audited entity and the audit committee shall take into consideration any findings or conclusions of any inspection report on the applicant statutory auditor or audit firm referred to in Article 26(8) and published by the competent authority pursuant to point (d) of Article 28; (f) the audited entity shall be able to demonstrate, upon request, to the competent authority referred to in Article 20 that the selection procedure was conducted in a fair manner. The audit committee shall be responsible for the selection procedure referred to in the first subparagraph. For the purposes of point (a) of the first subparagraph, the competent authority referred to in Article 20(1) shall make public a list of the statutory auditors and the audit firms concerned which shall be updated on an annual basis. The competent authority shall use the information provided by statutory auditors and audit firms pursuant to Article 14 to make the relevant calculations. 4. Public-interest entities which meet the criteria set out in points (f) and (t) of Article 2(1) of Directive 2003/71/EC shall not be required to apply the selection procedure referred to in paragraph 3. 5. The proposal to the general meeting of shareholders or members of the audited entity for the appointment of statutory auditors or audit firms shall include the recommendation and preference referred to in paragraph 2 made by the audit committee or the body performing equivalent functions. If the proposal departs from the preference of the audit committee, the proposal shall justify the reasons for not following the recommendation of the audit committee. However, the statutory auditor or audit firm recommended by the administrative or supervisory body must have participated in the selection procedure described in paragraph 3. This subparagraph shall not apply where the audit committee's functions are performed by the administrative or supervisory body. 6. Any clause of a contract entered into between a public-interest entity and a third party restricting the choice by the general meeting of shareholders or members of that entity, as referred to in Article 37 of Directive 2006/43/EC to certain categories or lists of statutory auditors or audit firms, as regards the appointment of a particular statutory auditor or audit firm to carry out the statutory audit of that entity shall be null and void. The public-interest entity shall inform the competent authorities referred to in Article 20 directly and without delay of any attempt by a third party to impose such a contractual clause or to otherwise improperly influence the decision of the general meeting of shareholders or members on the selection of a statutory auditor or an audit firm. 7. Member States may decide that a minimum number of statutory auditors or audit firms are to be appointed by public-interest entities in certain circumstances and establish the conditions governing the relations between the statutory auditors or audit firms appointed. If a Member State establishes any such requirement, it shall inform the Commission and the relevant European Supervisory Authority thereof. 8. Where the audited entity has a nomination committee in which shareholders or members have a considerable influence and which has the task of making recommendations on the selecting of auditors, Member States may allow that nomination committee to perform the functions of the audit committee that are laid down in this Article and require it to submit the recommendation referred to in paragraph 2 to the general meeting of shareholders or members. Article 17 Duration of the audit engagement 1. A public-interest entity shall appoint a statutory auditor or an audit firm for an initial engagement of at least one year. The engagement may be renewed. Neither the initial engagement of a particular statutory auditor or audit firm, nor this in combination with any renewed engagements therewith shall exceed a maximum duration of 10 years. 2. By way of derogation from paragraph 1, Member States may (a) require that the initial engagement referred to in paragraph 1 be for a period of more than one year; (b) set a maximum duration of less than 10 years for the engagements referred to in the second subparagraph of paragraph 1. 3. After the expiry of the maximum durations of engagements referred to in the second subparagraph of paragraph 1, or in point (b) of paragraph 2, or after the expiry of the durations of engagements extended in accordance with paragraphs 4 or 6, neither the statutory auditor or the audit firm nor, where applicable, any members of their networks within the Union shall undertake the statutory audit of the same public-interest entity within the following four-year period. 4. By way of derogation from paragraph 1 and point (b) of paragraph (2), Member States may provide that the maximum durations referred to in the second subparagraph of paragraph 1 and in point (b) of paragraph 2 may be extended to the maximum duration of: (a) 20 years, where a public tendering process for the statutory audit is conducted in accordance with paragraphs 2 to 5 of Article 16 and takes effect upon the expiry of the maximum durations referred to in the second subparagraph of paragraph 1 and in point (b) of paragraph 2; or (b) twenty four years, where, after the expiry of the maximum durations referred to in the second subparagraph of paragraph 1 and in point (b) of paragraph 2, more than one statutory auditor or audit firm is simultaneously engaged, provided that the statutory audit results in the presentation of the joint audit report as referred to in Article 28 of Directive 2006/43/EC. 5. The maximum durations referred to in the second subparagraph of paragraph 1 and in point (b) of paragraph 2 shall be extended only if, upon a recommendation of the audit committee, the administrative or supervisory body, proposes to the general meeting of shareholders or members, in accordance with national law, that the engagement be renewed and that proposal is approved. 6. After the expiry of the maximum durations referred to in the second subparagraph of paragraph 1, in point (b) of paragraph 2, or in paragraph 4, as appropriate, the public-interest entity may, on an exceptional basis, request that the competent authority referred to in Article 20(1) grant an extension to re-appoint the statutory auditor or the audit firm for a further engagement where the conditions in points (a) or (b) of paragraph 4 are met. Such an additional engagement shall not exceed two years. 7. The key audit partners responsible for carrying out a statutory audit shall cease their participation in the statutory audit of the audited entity not later than seven years from the date of their appointment. They shall not participate again in the statutory audit of the audited entity before three years have elapsed following that cessation. By way of derogation, Member States may require that key audit partners responsible for carrying out a statutory audit cease their participation in the statutory audit of the audited entity earlier than seven years from the date of their respective appointment. The statutory auditor or the audit firm shall establish an appropriate gradual rotation mechanism with regard to the most senior personnel involved in the statutory audit, including at least the persons who are registered as statutory auditors. The gradual rotation mechanism shall be applied in phases on the basis of individuals rather than of the entire engagement team. It shall be proportionate in view of the scale and the complexity of the activity of the statutory auditor or the audit firm. The statutory auditor or the audit firm shall be able to demonstrate to the competent authority that such mechanism is effectively applied and adapted to the scale and the complexity of the activity of the statutory auditor or the audit firm. 8. For the purposes of this Article, the duration of the audit engagement shall be calculated as from the first financial year covered in the audit engagement letter in which the statutory auditor or the audit firm has been appointed for the first time for the carrying-out of consecutive statutory audits for the same public-interest entity. For the purposes of this Article, the audit firm shall include other firms that the audit firm has acquired or that have merged with it. If there is uncertainty as to the date on which the statutory auditor or the audit firm began carrying out consecutive statutory audits for the public-interest entity, for example due to firm mergers, acquisitions, or changes in ownership structure, the statutory auditor or the audit firm shall immediately report such uncertainties to the competent authority, which shall ultimately determine the relevant date for the purposes of the first subparagraph. Article 18 Hand-over file Where a statutory auditor or an audit firm is replaced by another statutory auditor or audit firm, the former statutory auditor or audit firm shall comply with the requirements laid down in Article 23(3) of Directive 2006/43/EC. Subject to Article 15, the former statutory auditor or audit firm shall also grant the incoming statutory auditor or audit firm access to the additional reports referred to in Article 11 in respect of previous years and to any information transmitted to competent authorities pursuant to Articles 12 and 13. The former statutory auditor or audit firm shall be able to demonstrate to the competent authority that such information has been provided to the incoming statutory auditor or audit firm. Article 19 Dismissal and resignation of the statutory auditors or the audit firms Without prejudice to Article 38(1) of Directive 2006/43/EC, any competent authority designated by a Member State in accordance with Article 20(2) of this Regulation, shall forward the information concerning the dismissal or resignation of the statutory auditor or the audit firm during the engagement and an adequate explanation of the reasons therefor to the competent authority referred to in Article 20(1). TITLE IV SURVEILLANCE OF THE ACTIVITIES OF STATUTORY AUDITORS AND AUDIT FIRMS CARRYING OUT STATUTORY AUDIT OF PUBLIC-INTEREST ENTITIES CHAPTER I Competent authorities Article 20 Designation of competent authorities 1. Competent authorities responsible for carrying out the tasks provided for in this Regulation and for ensuring that the provisions of this Regulation are applied shall be designated from amongst the following: (a) the competent authority referred to in Article 24(1) of Directive 2004/109/EC; (b) the competent authority referred to in point (h) of Article 24(4) of Directive 2004/109/EC; (c) the competent authority referred to in Article 32 of Directive 2006/43/EC. 2. By way of derogation from paragraph 1, Member States may decide that the responsibility for ensuring that all or part of the provisions of Title III of this Regulation are applied is to be entrusted to, as appropriate, the competent authorities referred to in: (a) Article 48 of Directive 2004/39/EC; (b) Article 24(1) of Directive 2004/109/EC; (c) point (h) of Article 24(4) of Directive 2004/109/EC; (d) Article 20 of Directive 2007/64/EC; (e) Article 30 of Directive 2009/138/EC; (f) Article 4(1) of Directive 2013/36/EU; or to other authorities designated by national law. 3. Where more than one competent authority has been designated pursuant to paragraphs 1 and 2, those authorities shall be organised in such a manner that their tasks are clearly allocated. 4. Paragraphs 1, 2 and 3 shall be without prejudice to the right of a Member State to make separate legal and administrative arrangements for overseas countries and territories with which that Member State has special relations. 5. The Member States shall inform the Commission of the designation of competent authorities for the purposes of this Regulation. The Commission shall consolidate this information and make it public. Article 21 Conditions of independence The competent authorities shall be independent of statutory auditors and audit firms. The competent authorities may consult experts, as referred to in point (c) of Article 26(1), for the purpose of carrying out specific tasks and may also be assisted by experts when this is essential for the proper fulfilment of their tasks. In such instances, the experts shall not be involved in any decision-making. A person shall not be a member of the governing body, or responsible for the decision\u2013making, of those authorities if during his or her involvement or in the course of the three previous years that person: (a) has carried out statutory audits; (b) held voting rights in an audit firm; (c) was member of the administrative, management or supervisory body of an audit firm; (d) was a partner, employee of, or otherwise contracted by, an audit firm. The funding of those authorities shall be secure and free from undue influence by statutory auditors and audit firms. Article 22 Professional secrecy in relation to competent authorities The obligation of professional secrecy shall apply to all persons who are or have been employed or independently contracted by, or involved in the governance of, competent authorities or by any authority or body to which tasks have been delegated under Article 24 of this Regulation. Information covered by professional secrecy may not be disclosed to any other person or authority except by virtue of the obligations laid down in this Regulation or the laws, regulations or administrative procedures of a Member State. Article 23 Powers of competent authorities 1. Without prejudice to Article 26, in carrying out their tasks under this Regulation, the competent authorities or any other public authorities of a Member State may not interfere with the content of audit reports. 2. Member States shall ensure that the competent authorities have all the supervisory and investigatory powers that are necessary for the exercise of their functions under this Regulation in accordance with the provisions of Chapter VII of Directive 2006/43/EC. 3. The powers referred to in paragraph 2 of this Article shall include, at least, the power to: (a) access data related to the statutory audit or other documents held by statutory auditors or audit firms in any form relevant to the carrying out of their tasks and to receive or take a copy thereof; (b) obtain information related to the statutory audit from any person; (c) carry out on-site inspections of statutory auditors or audit firms; (d) refer matters for criminal prosecution; (e) request experts to carry out verifications or investigations; (f) take the administrative measures, and impose the sanctions referred to in Article 30a of Directive 2006/43/EC. The competent authorities may use the powers referred to in the first subparagraph only in relation to: (a) statutory auditors and audit firms carrying out statutory audit of public-interest entities; (b) persons involved in the activities of statutory auditors and audit firms carrying out statutory audit of public-interest entities; (c) audited public-interest entities, their affiliates and related third parties; (d) third parties to whom the statutory auditors and the audit firms carrying out statutory audit of public-interest entities have outsourced certain functions or activities; and (e) persons otherwise related or connected to statutory auditors and audit firms carrying out statutory audit of public-interest entities. 4. Member States shall ensure that the competent authorities are allowed to exercise their supervisory and investigatory powers in any of the following ways: (a) directly; (b) in collaboration with other authorities; (c) by application to the competent judicial authorities. 5. The supervisory and investigatory powers of competent authorities shall be exercised in full compliance with national law, and in particular, with the principles of respect for private life and the right of defence. 6. The processing of personal data processed in the exercise of the supervisory and investigatory powers pursuant to this Article shall be carried out in accordance with Directive 95/46/EC. Article 24 Delegation of tasks 1. Member States may delegate or allow the competent authorities referred to in Article 20(1) to delegate any of the tasks required to be undertaken pursuant to this Regulation to other authorities or bodies designated or otherwise authorised by law to carry out such tasks, except for tasks related to: (a) the quality assurance system referred to in Article 26; (b) investigations referred to in Article 23 of this Regulation and Article 32 of Directive 2006/43/EC arising from that quality assurance system or from a referral by another authority; and (c) sanctions and measures as referred to in Chapter VII of Directive 2006/43/EC related to the quality assurance reviews or investigation of statutory audits of public-interest entities. 2. Any execution of tasks by other authorities or bodies shall be the subject of an express delegation by the competent authority. The delegation shall specify the delegated tasks and the conditions under which they are to be carried out. Where the competent authority delegates tasks to other authorities or bodies, it shall be able to reclaim these competences on a case-by-case basis. 3. The authorities or bodies shall be organised in such a manner that there are no conflicts of interest. The ultimate responsibility for supervising compliance with this Regulation and with the implementing measures adopted pursuant thereto shall lie with the delegating competent authority. The competent authority shall inform the Commission and the competent authorities of Member States of any arrangement entered into with regard to the delegation of tasks, including the precise conditions governing such delegation. 4. By way of derogation from paragraph 1, Member States may decide to delegate the tasks referred to in point (c) of paragraph 1 to other authorities or bodies designated or otherwise authorised by law to carry out such tasks, when the majority of the persons involved in the governance of the authority or body concerned is independent from the audit profession. Article 25 Cooperation with other competent authorities at national level Competent authorities designated pursuant to Article 20(1) and, where appropriate, any authority to whom such a competent authority has delegated tasks shall cooperate at national level with: (a) the competent authorities referred to in Article 32(4) of Directive 2006/43/EC; (b) the authorities referred to in Article 20(2), whether or not they have been designated competent authorities for the purposes of this Regulation; (c) the financial intelligence units and the competent authorities referred to in Articles 21 and 37 of Directive 2005/60/EC. For the purposes of such cooperation, the obligation of professional secrecy under Article 22 of this Regulation shall apply. CHAPTER II Quality assurance, market monitoring, and transparency of competent authorities Article 26 Quality assurance 1. For the purposes of this Article: (a) \u2018inspections\u2019 means quality assurance reviews of statutory auditors and audit firms, which are led by an inspector and which do not constitute an investigation within the meaning of Article 32(5) of Directive 2006/43/EC; (b) \u2018inspector\u2019 means a reviewer who meets the requirements set out in point (a) of the first subparagraph of paragraph 5 of this Article and who is employed or otherwise contracted by a competent authority; (c) \u2018expert\u2019 means a natural person who has specific expertise in financial markets, financial reporting, auditing or other fields relevant for inspections, including practising statutory auditors. 2. The competent authorities designated under Article 20(1) shall establish an effective system of audit quality assurance. They shall carry out quality assurance reviews of statutory auditors and audit firms that carry out statutory audits of public-interest entities on the basis of an analysis of the risk and: (a) in the case of statutory auditors and audit firms carrying out statutory audits of public-interest entities other than those defined in points (17) and (18) of Article 2 of Directive 2006/43/EC at least every three years; and, (b) in cases other than those referred to in point (a), at least every six years. 3. The competent authority shall have the following responsibilities: (a) approval and amendment of the inspection methodologies, including inspection and follow-up manuals, reporting methodologies and periodic inspection programmes; (b) approval and amendment of inspection reports and follow-up reports; (c) approval and assignment of inspectors for each inspection. The competent authority shall allocate adequate resources to the quality assurance system. 4. The competent authority shall organise the quality assurance system in a manner that is independent of the reviewed statutory auditors and audit firms. The competent authority shall ensure that appropriate policies and procedures related to the independence and objectivity of the staff, including inspectors, and the management of the quality assurance system are put in place. 5. The competent authority shall comply with the following criteria when appointing inspectors: (a) inspectors shall have appropriate professional education and relevant experience in statutory audit and financial reporting combined with specific training on quality assurance reviews; (b) a person who is a practising statutory auditor or is employed by or otherwise associated with a statutory auditor or an audit firm shall not be allowed to act as an inspector; (c) a person shall not be allowed to act as an inspector in an inspection of a statutory auditor or an audit firm until at least three years have elapsed since that person ceased to be a partner or employee of that statutory auditor or of that audit firm or to be otherwise associated with that statutory auditor or audit firm; (d) inspectors shall declare that there are no conflicts of interest between them and the statutory auditor and the audit firm to be inspected. By way of derogation from point (b) of paragraph 1, a competent authority may contract experts for carrying out specific inspections when the number of inspectors within the authority is insufficient. The competent authority may also be assisted by experts when this is essential for the proper conduct of an inspection. In such instances, the competent authorities and the experts shall comply with the requirements of this paragraph. Experts shall not be involved in the governance of, or employed or otherwise contracted by professional associations and bodies but may be members of such associations or bodies. 6. The scope of inspections shall at least cover: (a) an assessment of the design of the internal quality control system of the statutory auditor or of the audit firm; (b) adequate compliance testing of procedures and a review of audit files of public-interest entities in order to verify the effectiveness of the internal quality control system; (c) in the light of the findings of the inspection under points (a) and (b) of this paragraph, an assessment of the contents of the most recent annual transparency report published by a statutory auditor or an audit firm in accordance with Article 13. 7. At least the following internal quality control policies and procedures of the statutory auditor or the audit firm shall be reviewed: (a) compliance by the statutory auditor or the audit firm with applicable auditing and quality control standards, and ethical and independence requirements, including those set out in Chapter IV of Directive 2006/43/EC and Articles 4 and 5 of this Regulation, as well as relevant laws, regulations and administrative provisions of the Member State concerned; (b) the quantity and quality of resources used, including compliance with continuing education requirements as set out in Article 13 of Directive 2006/43/EC; (c) compliance with the requirements set out in Article 4 of this Regulation on the audit fees charged. For the purposes of testing compliance, audit files shall be selected on the basis of an analysis of the risk of a failure to carry out a statutory audit adequately. Competent authorities shall also periodically review the methodologies used by statutory auditors and audit firms to carry out statutory audits. In addition to the inspection covered by the first subparagraph, competent authorities shall have the power to perform other inspections. 8. The findings and conclusions of inspections on which recommendations are based, including the findings and conclusions related to a transparency report, shall be communicated to and discussed with the inspected statutory auditor or audit firm before an inspection report is finalised. Recommendations of inspections shall be implemented by the inspected statutory auditor or audit firm within a reasonable period set by the competent authority. Such period shall not exceed 12 months in the case of recommendations on the internal quality control system of the statutory auditor or of the audit firm. 9. The inspection shall be the subject of a report which shall contain the main conclusions and recommendations of the quality assurance review. Article 27 Monitoring market quality and competition 1. The competent authorities designated under Article 20(1) and the European Competition Network (ECN), as appropriate, shall regularly monitor the developments in the market for providing statutory audit services to public-interest entities and shall in particular assess the following: (a) the risks arising from high incidence of quality deficiencies of a statutory auditor or an audit firm, including systematic deficiencies within an audit firm network, which may lead to the demise of any audit firm, the disruption in the provision of statutory audit services whether in a specific sector or across sectors, the further accumulation of risk of audit deficiencies and the impact on the overall stability of the financial sector; (b) the market concentration levels, including in specific sectors; (c) the performance of audit committees; (d) the need to adopt measures to mitigate the risks referred to in point (a). 2. By 17 June 2016, and at least every three years thereafter, each competent authority and the ECN, shall draw up a report on developments in the market for providing statutory audit services to public-interest entities and submit it to the CEAOB, ESMA, EBA, EIOPA and the Commission. The Commission, following consultations with the CEAOB, ESMA, EBA and EIOPA shall use those reports to draw up a joint report on those developments at Union level. That joint report shall be submitted to the Council, the European Central Bank and the European Systemic Risk Board, as well as, where appropriate, to the European Parliament. Article 28 Transparency of competent authorities Competent authorities shall be transparent and shall at least publish: (a) annual activity reports regarding their tasks under this Regulation; (b) annual work programmes regarding their tasks under this Regulation; (c) a report on the overall results of the quality assurance system on an annual basis. This report shall include information on recommendations issued, follow-up on the recommendations, supervisory measures taken and sanctions imposed. It shall also include quantitative information and other key performance information on financial resources and staffing, and the efficiency and effectiveness of the quality assurance system; (d) the aggregated information on the findings and conclusions of inspections referred to in the first subparagraph of Article 26(8). Member States may require the publication of those findings and conclusions on individual inspections. CHAPTER III Cooperation between competent authorities and relations with the european supervisory authorities Article 29 Obligation to cooperate The competent authorities of the Member States shall cooperate with each other where it is necessary for the purposes of this Regulation, including in cases where the conduct under investigation does not constitute an infringement of any legislative or regulatory provision in force in the Member State concerned. Article 30 Establishment of the CEAOB 1. Without prejudice to the organisation of national auditing oversight, the cooperation between competent authorities shall be organised within the framework of the CEAOB. 2. The CEAOB shall be composed of one member from each Member State who shall be high level representatives from the competent authorities referred to in Article 32(1) of Directive 2006/43/EC, and one member appointed by the ESMA, hereinafter referred to as \u2018members\u2019. 3. The EBA and EIOPA shall be invited to attend meetings of the CEAOB as observers. 4. The CEAOB shall meet at regular intervals and, where necessary, at the request of the Commission or a Member State. 5. Each member of the CEAOB shall have one vote, except the member appointed by ESMA, who shall not have voting rights. Unless otherwise stated, decisions of the CEAOB shall be taken by simple majority of its members. 6. The Chair of the CEAOB shall be elected from a list of applicants representing the competent authorities referred to in Article 32(1) of Directive 2006/43/EC, or removed, in each case by a two-thirds majority of members. The Chair shall be elected for a four-year term. The Chair may not serve consecutive terms in the same position, but may be re-elected after a cooling-off period of four years. The Vice-Chair shall be appointed or removed by the Commission. The Chair and the Vice-Chair shall not have voting rights. In the event that the Chair resigns or is removed before the end of his or her term of office, the Vice-Chair shall act as Chair until the next meeting of the CEAOB, which shall elect a Chair for the remainder of the term. 7. The CEAOB shall: (a) facilitate the exchange of information, expertise and best practices for the implementation of this Regulation and of Directive 2006/43/EC; (b) provide expert advice to the Commission as well as to the competent authorities, at their request, on issues related to the implementation of this Regulation and of Directive 2006/43/EC; (c) contribute to the technical assessment of public oversight systems of third countries and to the international cooperation between Member States and third countries in that area, as referred to in Articles 46(2) and 47(3) of Directive 2006/43/EC; (d) contribute to the technical examination of international auditing standards, including the processes for their elaboration, with a view to their adoption at Union level; (e) contribute to the improvement of cooperation mechanisms for the oversight of public-interest entities' statutory auditors, audit firms or the networks they belong to; (f) carry out other coordinating tasks in the cases provided for in this Regulation or in Directive 2006/43/EC. 8. For the purposes of carrying out its tasks referred to in point (c) of paragraph 7, the CEAOB shall request the assistance of ESMA, EBA or EIOPA insofar as its request relates to international cooperation between Member States and third countries in the field of statutory audit of public-interest entities supervised by those European Supervisory Authorities. Where such assistance is requested, ESMA, EBA or EIOPA shall assist the CEAOB in its task. 9. For the purposes of carrying out its tasks, the CEAOB may adopt non-binding guidelines or opinions. The Commission shall publish the guidelines and opinions adopted by the CEAOB. 10. The CEAOB shall assume all existing and on-going tasks, as appropriate, of the European Group of Audit Oversight Bodies (EGAOB) created by Commission Decision 2005/909/EC. 11. The CEAOB may establish sub-groups on a permanent or ad hoc basis to examine specific issues under the terms of reference established by it. Participation in the sub-group discussions may be extended to competent authorities from the countries of the European Economic Area (hereinafter referred to as EEA) in the field of audit oversight or by invitation, on a case-by-case basis, to competent authorities from non-EU/EEA countries, subject to the approval of the CEAOB members. The participation of a competent authority from a non-EU/EEA country may be subject to a limited time period. 12. The CEAOB shall establish a sub-group for the purpose of carrying out the tasks referred to in point (c) of paragraph 7. That sub-group shall be chaired by the member appointed by ESMA pursuant to paragraph 2. 13. At the request of at least three members, or on its own initiative, where this is considered useful and/or necessary, the Chair of the CEAOB may invite experts, including practitioners, with specific competence on a subject on the agenda to participate in the CEAOB's or its sub-group's deliberations as observers. The CEAOB may invite representatives of competent authorities from third countries which are competent in the field of audit oversight to participate in the CEAOB's or its sub-group's deliberations as observers. 14. The Secretariat of the CEAOB shall be provided by the Commission. The expenses of the CEAOB shall be included in the estimates of the Commission. 15. The Chair shall prepare the provisional agenda of each meeting of the CEAOB with due regard to members' written contributions. 16. The Chair or, in his or her absence, the Vice-Chair shall communicate the CEAOB views or positions only with the approval of the members. 17. The CEAOB's discussions shall not be public. 18. The CEAOB shall adopt its rules of procedure. Article 31 Cooperation with regard to quality assurance reviews, investigations and on-site inspections 1. Competent authorities shall take measures to ensure effective cooperation at Union level in respect of quality assurance reviews. 2. The competent authority of one Member State may request the assistance of the competent authority of another Member State with regard to the quality assurance reviews of statutory auditors or audit firms belonging to a network carrying out significant activities in the requested Member State. 3. Where a competent authority receives a request from a competent authority of another Member State to assist in the quality assurance review of a statutory auditor or an audit firm belonging to a network carrying out significant activities in that Member State, it shall allow the requesting competent authority to assist in such quality assurance review. The requesting competent authority shall not have the right to access information which might breach national security rules or adversely affect the sovereignty, security or public order of the requested Member State. 4. Where a competent authority concludes that activities contrary to the provisions of this Regulation are being carried out or have been carried out on the territory of another Member State, it shall notify the competent authority of the other Member State of that conclusion in as specific a manner as possible. The competent authority of the other Member State shall take appropriate action. It shall inform the notifying competent authority of the outcome of that action and, to the extent possible, of significant interim developments. 5. A competent authority of one Member State may request that an investigation be carried out by the competent authority of another Member State on the latter's territory. It may also request that some of its own personnel be allowed to accompany the personnel of the competent authority of that Member State in the course of the investigation, including with regard to on-site inspections. The investigation or inspection shall be subject throughout to the overall control of the Member State on whose territory it is carried out. 6. The requested competent authority may refuse to act on a request for an investigation to be carried out as provided for in the first subparagraph of paragraph 5, or on a request for its personnel to be accompanied by personnel of a competent authority of another Member State as provided for in the second subparagraph of paragraph 5, in the following cases: (a) where such an investigation or on-site inspection might breach national security rules or adversely affect the sovereignty, security or public order of the requested Member State; (b) where judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the requested Member State; (c) where a final judgment has already been delivered in respect of the same actions and the same persons by the authorities of the requested Member State. 7. In the event of a quality assurance review or an investigation with cross-border effects, the competent authorities of the Member States concerned may address a joint request to the CEAOB to coordinate the review or investigation. Article 32 Colleges of competent authorities 1. In order to facilitate the exercise of the tasks referred to in Articles 26, and 31(4) to(6) of this Regulation and Article 30 of Directive 2006/43/EC with regard to specific statutory auditors, audit firms or their networks, colleges may be established with the participation of the competent authority of the home Member State and of any other competent authority, provided that: (a) the statutory auditor or the audit firm is providing statutory audit services to public-interest entities within the jurisdiction of the Member States concerned; or (b) a branch which is a part of the audit firm is established within the jurisdiction of the Member States concerned. 2. In the case of specific statutory auditors or audit firms, the competent authority of the home Member State shall act as facilitator. 3. With regard to specific networks, competent authorities of the Member States where the network carries out significant activities may request the CEAOB to establish a college with the participation of the requesting competent authorities. 4. Within 15 working days of the establishment of the college of competent authorities with regard to a specific network, its members shall select a facilitator. In the absence of agreement, the CEAOB shall appoint a facilitator from among the members of the college. Members of the college shall review the selection of the facilitator at least every five years to ensure that the selected facilitator remains the most appropriate occupant of that position. 5. The facilitator shall chair the meetings of the college, coordinate the actions of the college and ensure efficient exchange of information among members of the college. 6. The facilitator shall, within 10 working days of his or her selection, establish written coordination arrangements within the framework of the college regarding the following matters: (a) information to be exchanged between competent authorities; (b) cases in which the competent authorities must consult each other; (c) cases in which the competent authorities may delegate supervisory tasks in accordance with Article 33. 7. In the absence of agreement concerning the written coordination arrangements under paragraph 6, any member of the college may refer the matter to the CEAOB. The facilitator shall give due consideration to any advice provided by the CEAOB concerning the written coordination arrangements before agreeing on their final text. The written coordination arrangements shall be set out in a single document containing full reasons for any significant deviation from the advice of the CEAOB. The facilitator shall transmit the written coordination arrangements to the members of the college and to the CEAOB. Article 33 Delegation of tasks The competent authority of the home Member State may delegate any of its tasks to the competent authority of another Member State subject to the agreement of that authority. Delegation of tasks shall not affect the responsibility of the delegating competent authority. Article 34 Confidentiality and professional secrecy in relation to cooperation among competent authorities 1. The obligation of professional secrecy shall apply to all persons who work or who have worked for the bodies involved in the framework of cooperation between competent authorities as referred to in Article 30. Information covered by professional secrecy shall not be disclosed to another person or authority except where such disclosure is necessary for legal proceedings or required by Union or national law. 2. Article 22 shall not prevent bodies involved in the framework of cooperation between competent authorities as referred to in Article 30 and the competent authorities from exchanging confidential information. Information thus exchanged shall be covered by the obligation of professional secrecy, to which persons employed or formerly employed by competent authorities are subject. 3. All the information exchanged under this Regulation between bodies involved in the framework of cooperation between competent authorities as referred to in Article 30, and the competent authorities and other authorities and bodies shall be treated as confidential, except where its disclosure is required by Union or national law. Article 35 Protection of personal data 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation. 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the CEAOB, ESMA, EBA and EIOPA in the context of this Regulation and of Directive 2006/43/EC. CHAPTER IV Cooperation with third-country authorities and with international organisations and bodies Article 36 Agreement on exchange of information 1. The competent authorities may conclude cooperation agreements on exchange of information with the competent authorities of third countries only if the information disclosed is subject, in the third countries concerned, to guarantees of professional secrecy which are at least equivalent to those set out in Articles 22 and 34. The competent authorities shall immediately communicate such agreements to the CEAOB and notify the Commission of them. Information shall only be exchanged under this Article where such exchange of information is necessary for the performance of the tasks of those competent authorities under this Regulation. Where such exchange of information involves the transfer of personal data to a third country, Member States shall comply with Directive 95/46/EC and the CEAOB shall comply with Regulation (EC) No 45/2001. 2. The competent authorities shall cooperate with the competent authorities or other relevant bodies of third countries regarding the quality assurance reviews and investigations of statutory auditors and audit firms. Upon request by a competent authority, the CEAOB shall contribute to such cooperation and to the establishment of supervisory convergence with third countries. 3. Where the cooperation or exchange of information relates to audit working papers or other documents held by statutory auditors or audit firms, Article 47 of Directive 2006/43/EC shall apply. 4. The CEAOB shall prepare guidelines on the content of the cooperation agreements and exchange of information referred to in this Article. Article 37 Disclosure of information received from third countries The competent authority of a Member State may disclose the confidential information received from competent authorities of third countries where a cooperation agreement so provides, only if it has obtained the express agreement of the competent authority which has transmitted the information and, where applicable, the information is disclosed only for the purposes for which that competent authority has given its agreement, or where such disclosure is required by Union or national law. Article 38 Disclosure of information transferred to third countries The competent authority of a Member State shall require that confidential information communicated by it to a competent authority of a third country may be disclosed by that competent authority to third parties or authorities only with the prior express agreement of the competent authority which has transmitted the information, in accordance with its national law and provided that the information is disclosed only for the purposes for which that competent authority of the Member State has given its agreement, or where such disclosure is required by Union or national law or is necessary for legal proceedings in that third country. Article 39 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 9 shall be conferred on the Commission for a period of five years from 16 June 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 9 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 9 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 40 Review and reports 1. The Commission shall review and report on the operation and effectiveness of the system of cooperation between competent authorities within the framework of the CEAOB, referred to in Article 30, in particular as regards the performance of the CEAOB tasks defined in paragraph 7 of that Article. 2. The review shall take into account international developments, particularly in relation to strengthening cooperation with the competent authorities of third countries and contributing to the improvement of cooperation mechanisms for the oversight of statutory auditors and audit firms of public-interest entities belonging to international audit networks. The Commission shall complete its review by 17 June 2019. 3. The report shall be submitted to the European Parliament and to the Council, together with a legislative proposal, if appropriate. That report shall consider the progress made in the field of cooperation between competent authorities within the framework of the CEAOB from the beginning of the operation of that framework and propose further steps to enhance the effectiveness of the cooperation between Member States' competent authorities. 4. By 17 June 2028 the Commission shall submit a report on the application of this Regulation to the European Parliament and to the Council. Article 41 Transitional provisions 1. As from 17 June 2020, a public-interest entity shall not enter into or renew an audit engagement with a given statutory auditor or audit firm if that statutory auditor or audit firm has been providing audit services to that public-interest entity for 20 and more consecutive years at the date of entry into force of this Regulation. 2. As from 17 June 2023, a public-interest entity shall not enter into or renew an audit engagement with a given statutory auditor or audit firm if that statutory auditor or audit firm has been providing audit services to that public-interest entity for 11 and more but less than 20 consecutive years at the date of entry into force of this Regulation. 3. Without prejudice to paragraphs 1 and 2, the audit engagements that were entered into before 16 June 2014 but which are still in place as at 17 June 2016 may remain applicable until the end of the maximum duration referred to in the second subparagraph of Article 17(1) or in point (b) of Article 17(2). Article 17(4) shall apply. 4. Article 16(3) shall only apply to audit engagements after the expiry of the period referred to in the second subparagraph of Article 17(1). Article 42 National provisions The Member States shall adopt appropriate provisions to ensure the effective application of this Regulation. Article 43 Repeal of Commission Decision 2005/909/EC Commission Decision 2005/909/EC is hereby repealed. Article 44 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 17 June 2016. However, Article 16(6) shall apply from 17 June 2017. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 April 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 191, 29.6.2012, p. 61. (2) Position of the European Parliament of 3 April 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014. (3) Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (OJ L 372, 31.12.1986, p. 1). (4) Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (OJ L 374, 31.12.1991, p. 7). (5) Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (OJ L 390, 31.12.2004, p. 38). (6) Directive 2007/64/EC of the European Parliament and of the Council of 13 November 2007 on payment services in the internal market amending Directives 97/7/EC, 2002/65/EC, 2005/60/EC and 2006/48/EC and repealing Directive 97/5/EC (OJ L 319, 5.12.2007, p. 1). (7) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32). (8) Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (OJ L 267, 10.10.2009, p. 7). (9) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1). (10) Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC (OJ L 145, 30.4.2004, p. 1). (11) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19). (12) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87). (13) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31.) (14) Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (OJ L 331, 15.12.2010, p. 1.) (15) Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (OJ L 309, 25.11.2005, p. 15.) (16) OJ L 120, 7.5.2008, p. 20. (17) European Supervisory Authority established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (18) European Supervisory Authority established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12). (19) European Supervisory Authority established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48). (20) Directive 2014/56/EU of the European Parliament and the Council of 16 April 2014 amending Directive 2006/43/EC on statutory audits of annual accounts and consolidated accounts (see page 196 of this Official Journal). (21) OJ C 336, 6.11.2012, p. 4. (22) Commission Decision 2005/909/EC of 14 December 2005 setting up a group of experts to advise the Commission and to facilitate cooperation between public oversight systems for statutory auditors and audit firms (OJ L 329, 16.12.2005, p. 38.) (23) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338.) (24) Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1.) (25) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (26) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12). (27) Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48).", "summary": "Rules for statutory audit of public-interest entities Rules for statutory audit of public-interest entities SUMMARY OF: Regulation (EU) No 537/2014 on specific requirements regarding statutory audit of public-interest entities WHAT IS THE AIM OF THE REGULATION? It aims to improve transparency in the audit market to strengthen public confidence in the annual and consolidated financial statements of public-interest entities (PIEs)*. It does so by laying down rules on: audits of public-interest entities;organisation and selection of statutory auditors and audit firms to guarantee their independence and avoid conflicts of interest;supervision of statutory auditors and audit firms. KEY POINTS The regulation sets out: Conditions for carrying out statutory audit of public interest entities, notably: Fee structures: payments for permitted non-audit services, if supplied for 3 or more consecutive years, should be limited to a maximum of 70% of the average of the statutory audit fees paid in the previous 3 years; statutory auditors or firms must declare to the audit committee* if they receive from a single PIE more than 15% of their total income 3 years running to determine whether this is a threat to their independence and if safeguards are in place. Ban on non-audit services: auditors carrying out a statutory audit of a PIE may not provide a wide range of non-audit activities, such as tax and legal advice or preparation of accounts, to the company, or parent or subsidiaries, while conducting the audit or during the previous financial year; EU governments may relax some of the restrictions or ban other services depending on their impact on an auditor\u2019s independence; auditors carrying out a statutory audit may provide non-audit services which are not specifically banned subject to the approval of the audit committee. Preparation for statutory audits: auditors, before accepting or continuing an engagement for a statutory audit of a PIE: must ensure the independence requirements are met;confirm annually in writing to the audit committee that the firm, partners and senior managers are independent from the PIE;discuss with the audit committee any threats to their independence and the safeguards applied. Irregularities: Auditors must: inform the company if they suspect financial irregularities or fraud have taken place and ask it to take the necessary action. If it fails to do so, they inform the appropriate authorities;report promptly to the appropriate authorities if, during an audit, they uncover illegal behaviour, a threat or doubt about the PIE\u2019s viability or decide to refuse to issue an audit opinion or to deliver an adverse or qualified one. Audit reports: statutory auditors produce an audit report and an additional report to the audit committee. Each is subject to a quality control review before publication; the audit report, drafted in clear and unambiguous language, describes, among other things, the most significant risks identified and the auditor\u2019s response to them and key observations; the additional report provides more detailed information, such as scope and timing of the audit and methodology used, for the audit committee. Additional requirements for statutory auditors: publication of an annual transparency report, available on its website for at least 5 years, containing detailed information about the company and its activities; submission annually to the relevant authority of income from PIEs broken down by revenue from statutory audit and various non-audit services; retention for at least 5 years of documents and information specified in the regulation. Appointment of statutory auditors or audit firms by public-interest entities a general meeting of shareholders or members of the PIE appoint the auditor on the basis of a recommendation from the audit committee. This contains at least 2 choices and explains why one is preferred; a PIE is free to invite any auditor or firm to submit proposals and the tender should not exclude small firms which received less than 15% of their total audit fees from PIEs the previous calendar year; a PIE appoints an auditor initially for 1 year and a maximum of 10 years. This can be raised to 20 years for a public tendering process and 24 years where a company is audited by at least 2 audit firms; a gap of 4 years must occur before an auditor can audit the same company again; auditors provide a hand-over file containing all relevant information and the most recent audit to their successor. Surveillance of statutory auditors and audit firms EU governments appoint an authority to supervise auditors and firms carrying out statutory audits of PIEs. The authorities: are independent of statutory auditors and audit firms;respect professional secrecy;may not interfere with the content of audit reports;have the necessary supervisory and investigative powers, including accessing data and inspecting firms, either on their own, working with other authorities or help of the judiciary;establish and implement an effective system of audit quality assurance;follow clear rules on the appointment of inspectors and their activities;monitor the market for the provision of statutory audit services to PIEs, especially the performance of audit committees, market concentration in specific sectors or any failings by firms;publish a report by 17/6/2016, and every 3 years thereafter, on market developments (based on these reports, the European Commission will publish a joint report on these developments at the EU level);publish annual activity reports, work programmes and assessments of the quality assurance system;cooperate with their counterparts in other EU countries, particularly on quality assurance reviews, investigations and on-site inspections;may exchange information with colleagues in non-EU countries subject to certain conditions. The regulation establishes the Committee of European Auditing Oversight Bodies (CEAOB). This: contains one senior representative from each national authority and one from the European Securities and Markets Authority;provides advice to the European Commission and national authorities, contributes technical expertise, plays a coordinating role and encourages exchange of information, expertise and best practice;may establish permanent or ad hoc sub-groups on specific issues. Transitional measures From 17 June 2020, a PIE may not renew a contract with a statutory auditor or audit firm if the latter has been providing it with audit services for 20 or more consecutive years when the regulation came into force; From 17 June 2023, the same restriction applies if the services have been provided for between 11 and 20 consecutive years. The regulation repeals Commission Decision 2005/909/EC. FROM WHEN DOES THE REGULATION APPLY? It has applied since 17 June 2016. BACKGROUND The regulation complements Directive 2006/43/EC which applies to all statutory audits (see summary) with regard to public-interest entities. In 2017, the Commission published a report on monitoring developments in the EU market for providing statutory audit services to public-interest entities In addition to increasing transparency in the audit market, the regulation encourages a wider choice of audit providers in an area highly concentrated in a few big accounting firms. For more information, see: Regulation on statutory audit of public-interest entities (Audit regulation) (European Commission). KEY TERMS Public-interest entity: companies with a significant public interest because of the nature of their business, size or number of employees or corporate status, including banks, insurance firms and listed companies. Audit committee: each PIE has an audit committee of non-executive members or members of its supervisory body. MAIN DOCUMENT Regulation (EU) No 537/2014 of the European Parliament and of the Council of 16 April 2014 on specific requirements regarding statutory audit of public-interest entities and repealing Commission Decision 2005/909/EC (OJ L 158, 27.5.2014, pp. 77-112) Successive amendments to Regulation (EU) No 537/2014 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Report from the Commission to the Council, the European Central Bank, the European Systemic Risk Board and the European Parliament on monitoring developments in the EU market for providing statutory audit services to public-interest entities pursuant to Article 27 of Regulation (EU) 537/2014 (COM(2017) 464 final, 7.9.2017) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, pp. 87-107) See consolidated version. last update 28.07.2020"}
{"article": "28.12.2013 EN Official Journal of the European Union L 354/22 REGULATION (EU) No 1380/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Council Regulation (EC) No 2371/2002 (4) established a Community system for the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (CFP). (2) The scope of the CFP includes the conservation of marine biological resources and the management of fisheries targeting them. In addition, it includes, in relation to market measures and financial measures in support of its objectives, fresh water biological resources and aquaculture activities, as well as the processing and marketing of fishery and aquaculture products, where such activities take place on the territory of Member States or in Union waters, including by fishing vessels flying the flag of, and registered in, third countries, by Union fishing vessels, or by nationals of Member States, without prejudice to the primary responsibility of the flag State, bearing in mind the provisions of Article 117 of the United Nations Convention on the Law of the Sea of 10 December 1982 (5) (UNCLOS). (3) Recreational fisheries can have a significant impact on fish resources and Member States should, therefore, ensure that they are conducted in a manner that is compatible with the objectives of the CFP. (4) The CFP should ensure that fishing and aquaculture activities contribute to long-term environmental, economic, and social sustainability. It should include rules that aim to ensure the traceability, security and quality of products marketed in the Union. Furthermore, the CFP should contribute to increased productivity, to a fair standard of living for the fisheries sector including small-scale fisheries, and to stable markets, and it should ensure the availability of food supplies and that they reach consumers at reasonable prices. The CFP should contribute to the Europe 2020 Strategy for smart, sustainable and inclusive growth, and should help to achieve the objectives set out therein. (5) The Union is a contracting party to UNCLOS (6) and, pursuant to Council Decision 98/414/EC (7), to the United Nations Agreement on the implementation of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks of 4 December 1995 (8) (UN Fish Stocks Agreement) and, pursuant to Council Decision 96/428/EC (9), to the Agreement to promote compliance with international conservation and management measures by fishing vessels on the high seas of 24 November 1993 of the Food and Agriculture Organisation of the United Nations (10). (6) Those international instruments predominantly lay down conservation obligations, including obligations to take conservation and management measures designed to maintain or restore marine resources at levels which can produce the maximum sustainable yield both within sea areas under national jurisdiction and on the high seas, and to cooperate with other States to that end, obligations to apply the precautionary approach widely to conservation, management and exploitation of fish stocks, obligations to ensure compatibility of conservation and management measures where marine resources occur in sea areas of different jurisdictional status and obligations to have due regard to other legitimate uses of the seas. The CFP should, therefore, contribute to the Union's implementation of its international obligations under those international instruments. Where Member States adopt conservation and management measures, for which they have been empowered within the framework of the CFP, they should also act in a manner which is fully consistent with the international obligations regarding conservation and cooperation under those international instruments. (7) At the World Summit on Sustainable Development at Johannesburg in 2002, the Union and its Member States committed themselves to act against the continued decline of many fish stocks. Therefore, the Union should improve the CFP by adapting exploitation rates so as to ensure that, within a reasonable time-frame, the exploitation of marine biological resources restores and maintains populations of harvested stocks above levels that can produce the maximum sustainable yield. The exploitation rates should be achieved by 2015. Achieving those exploitation rates by a later date should be allowed only if achieving them by 2015 would seriously jeopardise the social and economic sustainability of the fishing fleets involved. After 2015, those rates should be achieved as soon as possible and in any event no later than 2020. Where scientific information is insufficient to determine those levels, approximative parameters may be considered. (8) Management decisions relating to maximum sustainable yield in mixed fisheries should take into account the difficulty of fishing all stocks in a mixed fishery at maximum sustainable yield at the same time, in particular where scientific advice indicates that it is very difficult to avoid the phenomenon of \"choke species\" by increasing the selectivity of the fishing gears used. Appropriate scientific bodies should be requested to provide advice on the appropriate fishing mortality levels in such circumstances. (9) The CFP should ensure coherence with the fisheries targets laid down in the Decision by the Conference of the Parties to the Convention on Biological Diversity on the Strategic Plan for Biodiversity 2011 \u2013 2020, and with the biodiversity targets adopted by the European Council of 25 and 26 March 2010. (10) Sustainable exploitation of marine biological resources should be based on the precautionary approach, which derives from the precautionary principle referred to in the first subparagraph of Article 191(2) of the Treaty, taking into account available scientific data. (11) The CFP should contribute to the protection of the marine environment, to the sustainable management of all commercially exploited species, and in particular to the achievement of good environmental status by 2020, as set out in Article 1(1) of Directive 2008/56/EC of the European Parliament and of the Council (11). (12) The CFP should also contribute to the supplying of highly nutritional food to the Union market and to reducing the Union market's dependence on food imports. It should also foster direct and indirect job creation and economic development in coastal areas. (13) An ecosystem-based approach to fisheries management needs to be implemented, environmental impacts of fishing activities should be limited and unwanted catches should be avoided and reduced as far as possible. (14) It is important for the management of the CFP to be guided by principles of good governance. Those principles include decision-making based on best available scientific advice, broad stakeholder involvement and a long-term perspective. The successful management of the CFP also depends on a clear definition of responsibilities at Union, regional, national and local levels and on the mutual compatibility of the measures taken and their consistency with other Union policies. (15) The CFP should contribute to the improvement of safety and working conditions for fishing operators. (16) The CFP should pay full regard, where relevant, to animal health, animal welfare, food and feed safety. (17) Since all matters related to Europe's oceans and seas are interlinked, the CFP should be implemented in a way that is consistent with other Union policies and, in particular, that takes into account interactions with Union actions in other maritime policy areas. Coherence should be ensured in the management of different sectoral policies within the Baltic Sea, North Sea, Celtic seas, Bay of Biscay and the Iberian Coast, Mediterranean and Black Sea sea basins. (18) Union fishing vessels should have equal access to Union waters and resources subject to the rules of the CFP. (19) Existing rules restricting access to resources within the 12 nautical mile zones of Member States have operated satisfactorily, benefiting conservation by restricting fishing effort in the most sensitive part of Union waters. Those rules have also preserved the traditional fishing activities on which the social and economic development of certain coastal communities is highly dependent. Those rules should therefore continue to apply. Member States should endeavour to give preferential access for small-scale, artisanal or coastal fishermen. (20) Small offshore islands which are dependent on fishing should, where appropriate, be especially recognised and supported in order to enable them to survive and prosper. (21) Marine biological resources around the Union outermost regions referred to in the first paragraph of Article 349 of the Treaty should be especially protected since they contribute to the preservation of the local economy of those territories, having regard to their structural, social and economic situation. Certain fishing activities in those waters should therefore be limited to fishing vessels registered in the ports of those territories. (22) In order to contribute to the conservation of living aquatic resources and marine ecosystems, the Union should endeavour to protect areas that are biologically sensitive, by designating them as protected areas. In such areas, it should be possible to restrict or to prohibit fishing activities. When deciding which areas to designate, particular attention should be paid to those in which there is clear evidence of heavy concentrations of fish below minimum conservation reference size and of spawning grounds, and to areas which are deemed to be bio-geographically sensitive. Account should also be taken of existing conservation areas. In order to facilitate the designation process, Member States should identify suitable areas, including areas that form part of a coherent network, and, where appropriate, should cooperate with one another, preparing and sending joint recommendations to the Commission. In order to establish protected areas more effectively, it should be possible for the Commission to be empowered to establish them in a multiannual plan. In order to ensure a suitable level of democratic accountability and control, the Commission should regularly report to the European Parliament and to the Council on the functioning of those protected areas. (23) The objective of sustainable exploitation of marine biological resources is more effectively achieved through a multiannual approach to fisheries management, establishing as a priority multiannual plans reflecting the specificities of different fisheries. (24) Multiannual plans should, where possible, cover multiple stocks where those stocks are jointly exploited. The multiannual plans should establish the framework for the sustainable exploitation of stocks and marine ecosystems concerned, defining clear time-frames and safeguard mechanisms for unforeseen developments. Multiannual plans should also be governed by clearly defined management objectives in order to contribute to the sustainable exploitation of the stocks and to the protection of the marine ecosystems concerned. Those plans should be adopted in consultation with Advisory Councils, operators in the fishing industry, scientists and other stakeholders having an interest in fisheries management. (25) Directive 2009/147/EC of the European Parliament and of the Council (12), Council Directive 92/43/EEC (13) and Directive 2008/56/EC impose certain obligations on Member States as regards special protection areas, special areas of conservation and marine protected areas, respectively. Such measures might require the adoption of measures falling under the CFP. It is, therefore, appropriate to authorise Member States to adopt, in the waters under their sovereignty or jurisdiction, such conservation measures that are necessary to comply with their obligations under those Union acts where such measures do not affect the fisheries interests of other Member States. Where such measures might affect fisheries interests of other Member States, the power to adopt such measures should be granted to the Commission and recourse should be had to regional cooperation among the Member States concerned. (26) Measures are needed to reduce the current high levels of unwanted catches and to gradually eliminate discards. Unwanted catches and discards constitute a substantial waste and negatively affect the sustainable exploitation of marine biological resources and marine ecosystems and the financial viability of fisheries. An obligation to land all catches (\"the landing obligation\") of species which are subject to catch limits and, in the Mediterranean Sea, also catches of species which are subject to minimum sizes, made during fishing activities in Union waters or by Union fishing vessels should be established and gradually implemented and rules that have so far obliged fishermen to discard should be repealed. (27) The landing obligation should be introduced on a fishery-by-fishery basis. Fishermen should be allowed to continue discarding species which, according to the best available scientific advice, have a high survival rate when released into the sea. (28) In order to make the landing obligation workable and to mitigate the effect of varying yearly catch compositions, Member States should be allowed to transfer quotas between years, up to a certain percentage. (29) In the management of the landing obligation, it is necessary that Member States do their utmost to reduce unwanted catches. To this end, improvements of selective fishing techniques to avoid and reduce, as far as possible, unwanted catches must have high priority. It is important for Member States to distribute quotas between vessels in a mix that reflects as far as possible the expected composition of species in the fisheries. In the event of a mismatch between available quotas and actual fishing pattern, Member States should consider adjustments through quota swaps with other Member States, including on a permanent basis. Member States should also consider facilitating the pooling by vessel owners of individual quotas, for example at the level of producer organisations or groups of vessel owners. Ultimately, Member States should consider counting by-catch species against the quota of the target species, depending on the conservation status of the by-catch species. (30) The destination of landings of catches of fish under the minimum conservation reference size should be limited and should exclude sale for human consumption. (31) In order to cater for unwanted catches that are unavoidable even when all the measures for their reduction are applied, certain de minimis exemptions from the landing obligation should be established for the fisheries to which the landing obligation applies, primarily through multiannual plans. (32) Subject to scientific advice and without jeopardising the objectives of maximum sustainable yield or increasing fishing mortality, where the landing obligation, including the obligation to document catches, applies, an increase of related fishing opportunities should be possible, in order to take into account the fact that fish previously discarded will be landed. (33) Access to a fishery should be based on transparent and objective criteria including those of an environmental, social and economic nature. Member States should promote responsible fishing by providing incentives to those operators who fish in the least environmentally damaging way and who provide the greatest benefits for society. (34) For stocks for which no multiannual plan has been established, exploitation rates delivering maximum sustainable yield should be ensured by setting catch or fishing effort limits. If available data is insufficient, fisheries should be managed by using approximative parameters. (35) In view of the precarious economic state of the fishing industry and the dependence of certain coastal communities on fishing, it is necessary to ensure the relative stability of fishing activities by allocating fishing opportunities among Member States, based on a predictable share of the stocks for each Member State. (36) Such relative stability of fishing activities, given the temporary biological situation of stocks, should safeguard and take full account of the particular needs of regions where local communities are especially dependent on fisheries and related activities, as decided by the Council in its Resolution of 3 November 1976 (14), and in particular Annex VII thereto. (37) Therefore, it is in this sense that the concept of relative stability should be understood. (38) The Commission should be authorised to adopt temporary measures in the event of a serious threat, requiring immediate action, to the conservation of marine biological resources or to the marine ecosystem resulting from fishing activities. Those measures should be established within defined time-frames and should be operational for a fixed period of time. (39) Member States should cooperate at regional level in order to adopt joint recommendations and other instruments for the development and implementation of conservation measures and measures affecting fishing activity in areas protected by environmental law. In the framework of regional cooperation, the Commission should only adopt conservation measures through implementing acts or delegated acts where all Member States concerned in a region agree on a joint recommendation. In the absence of a joint recommendation, the Commission should submit a proposal for the relevant measures pursuant to the Treaty. (40) Member States should be empowered to adopt conservation and management measures for stocks in Union waters applicable solely to Union fishing vessels flying their flag. (41) In their 12 nautical mile zones, Member States should be empowered to adopt conservation and management measures applicable to all Union fishing vessels, provided that, where such measures apply to Union fishing vessels from other Member States, they are non-discriminatory, prior consultation of other Member States concerned has taken place and the Union has not adopted measures specifically addressing conservation and management within the 12 nautical mile zone concerned. (42) Member States should be able to introduce a system of transferable fishing concessions. (43) Member States should take specific measures to align the number of Union fishing vessels with available resources, based on their assessments of the balance between the fishing capacity of their fleets and the fishing opportunities available to them. The assessments should be made in accordance with Commission guidelines and be presented in an annual report to be transmitted to the Commission. Those reports should be made public. Each Member State should be able to choose the measures and instruments which it wishes to adopt in order to reduce excessive fishing capacity. (44) In addition, compulsory maximum fleet capacity ceilings and national entry/exit schemes in relation to decommissioning funding should be maintained for the purpose of managing and adjusting fishing capacity. (45) Member States should record the minimum information on characteristics and activities of Union fishing vessels flying their flag. Those records should be made available to the Commission for the purpose of monitoring the size of Member States' fleets. (46) Fisheries management based on the best available scientific advice requires harmonised, reliable and accurate data sets. Therefore, Member States should collect data on fleets and their fishing activities, in particular biological data on catches, including discards and survey information on fish stocks and on the potential environmental impact of fishing activities on the marine ecosystem. Member States should manage and make the collected data available to end-users and to other interested parties. Member States should cooperate with each other and with the Commission to coordinate data collection activities. Where relevant, Member States should also cooperate with third countries regarding data collection. Member States should provide the Commission, for its assessment, with an annual report on their data collection activities, which shall be made public. (47) Data collection should include data which facilitate the economic assessment of undertakings active in the fisheries sector, in aquaculture and in the processing of fisheries and aquaculture products and of employment trends in those industries. (48) The Scientific, Technical and Economic Committee for Fisheries (STECF), as established by Commission Decision 2005/629/EC (15), may be consulted on matters pertaining to the conservation and management of marine biological resources in order to ensure the required assistance of highly qualified scientific personnel, particularly in the application of biological, economic, environmental, social and technical disciplines. (49) Policy-oriented fisheries science should be reinforced by means of nationally-adopted fisheries scientific data collection, research and innovation programmes implemented in coordination with other Member States and within Union research and innovation frameworks. Better cooperation between industry and scientists should also be fostered. (50) The Union should promote the objectives of the CFP internationally, ensuring that Union fishing activities outside Union waters are based on the same principles and standards as those applicable under Union law, and promoting a level\u2013playing field for Union operators and third-country operators. To this end, the Union should seek to lead the process of strengthening the performance of regional and international organisations in order to better enable them to conserve and manage marine living resources under their purview, including combating illegal, unreported and unregulated (IUU) fishing. The Union should cooperate with third countries and international organisations for the purpose of improving compliance with international measures, including combating IUU. The position of the Union should be based on the best available scientific advice. (51) Sustainable fisheries partnership agreements with third countries should ensure that Union fishing activities in third country waters are based on the best available scientific advice and relevant information exchange, ensuring a sustainable exploitation of the marine biological resources, transparency as regards the determination of the surplus and, consequently, a management of the resources that is consistent with the objectives of the CFP. Those agreements, which provide for access to resources commensurate with the interests of the Union fleet in exchange for a financial contribution from the Union, should contribute to the establishment of a high quality governance framework to ensure, in particular, efficient data collection, monitoring, control and surveillance measures. (52) Respect for democratic principles and human rights, as laid down in the Universal Declaration of Human Rights and other relevant international human rights instruments, and for the principle of the rule of law, should constitute an essential element of sustainable fisheries partnership agreements, which should contain a specific human rights clause. The introduction of a human rights clause in sustainable fisheries partnership agreements should be fully consistent with the overall Union development policy objectives. (53) Aquaculture should contribute to the preservation of the food production potential on a sustainable basis throughout the Union so as to guarantee long-term food security, including food supplies, as well as growth and employment for Union citizens, and to contribute to meeting the growing world demand for aquatic food. (54) The Commission's Strategy for the Sustainable Development of European Aquaculture adopted in 2009, which was welcomed and endorsed by the Council and welcomed by the European Parliament, noted the need for the creation and promotion of a level-playing field for aquaculture as the basis for its sustainable development. (55) Aquaculture activities in the Union are influenced by different conditions across national borders, including as regards authorisations for the operators. Therefore, Union strategic guidelines for national strategic plans should be developed to improve the competitiveness of the aquaculture industry, supporting its development and innovation, and encouraging economic activity, diversification and improving the quality of life in coastal and inland areas. Furthermore, mechanisms should be introduced for the exchange between Member States of information and best practices through an open method of coordination of national measures concerning business security, access to Union waters and space, and the simplification of licensing procedures. (56) The specific nature of aquaculture requires an Advisory Council for stakeholder consultation on elements of Union policies which could affect aquaculture. (57) There is a need to strengthen the competitiveness of the Union fishery and aquaculture sector, and for simplification in support of better management of its production and marketing activities. The common market organisation for fishery and aquaculture products should ensure a level-playing field for all fishery and aquaculture products marketed in the Union regardless of their origin, should enable consumers to make better informed choices and support responsible consumption, and should improve the economic knowledge and understanding of the Union markets along the supply chain. (58) The common market organisation should be implemented in compliance with international commitments of the Union, in particular with regard to the provisions of the World Trade Organisation. (59) In order to ensure compliance with the rules of the CFP, an effective system of control, inspection and enforcement should be established, that includes the fight against IUU fishing activities. (60) The use of modern and effective technologies should be promoted in the framework of the Union system for control, inspection, and enforcement. Member States and the Commission should have the possibility to conduct pilot projects on new control technologies and data management systems. (61) In order to ensure that the conditions in different Member States for the application of control and enforcement rules are comparable, cooperation between Member States on identifying effective, proportionate and dissuasive penalties should be encouraged. (62) In order to ensure the involvement of operators in the Union data collection and in the Union system for control, inspection, and enforcement, Member States should be able to require their operators to contribute proportionally to the corresponding operational costs. (63) The objectives of the CFP cannot be sufficiently achieved by Member States alone, given the problems encountered in the development of the fishing industry and its management, and the limits on the financial resources of the Member States. Therefore, to contribute to the achievement of those objectives, multiannual Union financial assistance should be granted that is focused on the priorities of the CFP and tailored to the specific features of the fishing industry in individual Member States. (64) Union financial assistance should be made conditional upon compliance by Member States and operators, including vessel owners, with the rules of the CFP. Subject to specific rules to be adopted, Union financial assistance should be interrupted, suspended or corrected in cases of non-compliance with a specific obligation of the CFP by a Member State or a serious infringement of those rules by an operator. (65) Dialogue with stakeholders has proven to be essential for achieving the objectives of the CFP. Taking into account the diverse conditions throughout Union waters and the increased regionalisation of the CFP, Advisory Councils should enable the CFP to benefit from the knowledge and experience of all stakeholders. (66) In view of the special characteristics of the outermost regions, of aquaculture, of markets and of the Black Sea, it is appropriate to establish a new Advisory Council for each of them. (67) The power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of the adoption of conservation measures accompanying certain environmental obligations by Member States, the adapting of the landing obligation for the purpose of complying with the Union's international obligations, the extension of the landing obligation to other species using the regionalisation process, the adoption of specific discard plans using the regionalisation process, the adoption of de minimis exemptions to the landing obligation if no other implementation measure for that obligation has been adopted, and the establishment of detailed rules for the functioning of Advisory Councils. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (68) In order to ensure uniform conditions for the implementation of the provisions of this Regulation in respect of temporary measures to alleviate a serious threat to the conservation of marine biological resources, of the entry-exit scheme in fleet management and of the recording, format and transmission of data for the Union fishing fleet register, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (16). (69) In accordance with the principle of proportionality, as set out in Article 5 of the Treaty on European Union, this Regulation does not go beyond what is necessary to achieve its objectives. (70) Council Decision 2004/585/EC (17) should be repealed upon entry in force of the corresponding rules pursuant to this Regulation. (71) By reason of the number and importance of the amendments to be made, Regulation (EC) No 2371/2002 should be repealed, HAVE ADOPTED THIS REGULATION: PART I GENERAL PROVISIONS Article 1 Scope 1. The Common Fisheries Policy (CFP) shall cover: (a) the conservation of marine biological resources and the management of fisheries and fleets exploiting such resources; (b) in relation to measures on markets and financial measures in support of the implementation of the CFP: fresh water biological resources, aquaculture, and the processing and marketing of fisheries and aquaculture products. 2. The CFP shall cover the activities referred to in paragraph 1 where they are carried out: (a) on the territory of Member States to which the Treaty applies; (b) in Union waters, including by fishing vessels flying the flag of, and registered in, third countries; (c) by Union fishing vessels outside Union waters; or (d) by nationals of Member States, without prejudice to the primary responsibility of the flag State. Article 2 Objectives 1. The CFP shall ensure that fishing and aquaculture activities are environmentally sustainable in the long-term and are managed in a way that is consistent with the objectives of achieving economic, social and employment benefits, and of contributing to the availability of food supplies. 2. The CFP shall apply the precautionary approach to fisheries management, and shall aim to ensure that exploitation of living marine biological resources restores and maintains populations of harvested species above levels which can produce the maximum sustainable yield. In order to reach the objective of progressively restoring and maintaining populations of fish stocks above biomass levels capable of producing maximum sustainable yield, the maximum sustainable yield exploitation rate shall be achieved by 2015 where possible and, on a progressive, incremental basis at the latest by 2020 for all stocks. 3. The CFP shall implement the ecosystem-based approach to fisheries management so as to ensure that negative impacts of fishing activities on the marine ecosystem are minimised, and shall endeavour to ensure that aquaculture and fisheries activities avoid the degradation of the marine environment. 4. The CFP shall contribute to the collection of scientific data. 5. The CFP shall, in particular: (a) gradually eliminate discards, on a case-by-case basis, taking into account the best available scientific advice, by avoiding and reducing, as far as possible, unwanted catches, and by gradually ensuring that catches are landed; (b) where necessary, make the best use of unwanted catches, without creating a market for such of those catches that are below the minimum conservation reference size; (c) provide conditions for economically viable and competitive fishing capture and processing industry and land-based fishing related activity; (d) provide for measures to adjust the fishing capacity of the fleets to levels of fishing opportunities consistent with paragraph 2, with a view to having economically viable fleets without overexploiting marine biological resources; (e) promote the development of sustainable Union aquaculture activities to contribute to food supplies and security and employment; (f) contribute to a fair standard of living for those who depend on fishing activities, bearing in mind coastal fisheries and socio-economic aspects; (g) contribute to an efficient and transparent internal market for fisheries and aquaculture products and contribute to ensuring a level\u2013playing field for fisheries and aquaculture products marketed in the Union; (h) take into account the interests of both consumers and producers; (i) promote coastal fishing activities, taking into account socio-economic aspects; (j) be coherent with the Union environmental legislation, in particular with the objective of achieving a good environmental status by 2020 as set out in Article 1(1) of Directive 2008/56/EC, as well as with other Union policies. Article 3 Principles of good governance The CFP shall be guided by the following principles of good governance: (a) the clear definition of responsibilities at the Union, regional, national and local levels; (b) the taking into account of regional specificities, through a regionalised approach; (c) the establishment of measures in accordance with the best available scientific advice; (d) a long-term perspective; (e) administrative cost efficiency; (f) appropriate involvement of stakeholders, in particular Advisory Councils, at all stages - from conception to implementation of the measures; (g) the primary responsibility of the flag State; (h) consistency with other Union policies; (i) the use of impact assessments as appropriate; (j) coherence between the internal and external dimension of the CFP; (k) transparency of data handling in accordance with existing legal requirements, with due respect for private life, the protection of personal data and confidentiality rules; availability of data to the appropriate scientific bodies, other bodies with a scientific or management interest, and other defined end-users. Article 4 Definitions 1. For the purpose of this Regulation the following definitions shall apply: (1) 'Union waters' means the waters under the sovereignty or jurisdiction of the Member States, with the exception of the waters adjacent to the territories listed in Annex II to the Treaty; (2) 'marine biological resources' means available and accessible living marine aquatic species, including anadromous and catadromous species during their marine life; (3) 'fresh water biological resources' means available and accessible living fresh water aquatic species; (4) 'fishing vessel' means any vessel equipped for commercial exploitation of marine biological resources or a blue fin tuna trap; (5) 'Union fishing vessel' means a fishing vessel flying the flag of a Member State and registered in the Union; (6) 'entry to the fishing fleet' means registration of a fishing vessel in the fishing vessel register of a Member State; (7) 'maximum sustainable yield' means the highest theoretical equilibrium yield that can be continuously taken on average from a stock under existing average environmental conditions without significantly affecting the reproduction process; (8) 'precautionary approach to fisheries management', as referred to in Article 6 of the UN Fish Stocks Agreement, means an approach according to which the absence of adequate scientific information should not justify postponing or failing to take management measures to conserve target species, associated or dependent species and non-target species and their environment; (9) 'ecosystem-based approach to fisheries management' means an integrated approach to managing fisheries within ecologically meaningful boundaries which seeks to manage the use of natural resources, taking account of fishing and other human activities, while preserving both the biological wealth and the biological processes necessary to safeguard the composition, structure and functioning of the habitats of the ecosystem affected, by taking into account the knowledge and uncertainties regarding biotic, abiotic and human components of ecosystems; (10) 'discards' means catches that are returned to the sea; (11) 'low impact fishing' means utilising selective fishing techniques which have a low detrimental impact on marine ecosystems or which may result in low fuel emissions, or both; (12) 'selective fishing' means fishing with fishing methods or fishing gears that target and capture organisms by size or species during the fishing operation, allowing non-target specimens to be avoided or released unharmed; (13) 'fishing mortality rate' means the rate at which biomass or individuals are removed from a stock by means of fishery activities over a given period; (14) 'stock' means a marine biological resource that occurs in a given management area; (15) 'catch limit' means, as appropriate, either a quantitative limit on catches of a fish stock or group of fish stocks over a given period where such fish stocks or group of fish stocks are subject to an obligation to land, or a quantitative limit on landings of a fish stock or group of fish stocks over a given period for which the obligation to land does not apply; (16) 'conservation reference point' means values of fish stock population parameters (such as biomass or fishing mortality rate) used in fisheries management, for example in respect of an acceptable level of biological risk or a desired level of yield; (17) 'minimum conservation reference size' means the size of a living marine aquatic species taking into account maturity, as established by Union law, below which restrictions or incentives apply that aim to avoid capture through fishing activity; such size replaces, where relevant, the minimum landing size; (18) 'stock within safe biological limits' means a stock with a high probability that its estimated spawning biomass at the end of the previous year is higher than the limit biomass reference point (Blim) and its estimated fishing mortality rate for the previous year is less than the limit fishing mortality rate reference point (Flim); (19) 'safeguard' means a precautionary measure designed to avoid something undesirable occurring; (20) 'technical measure' means a measure that regulates the composition of catches by species and size and the impacts on components of the ecosystems resulting from fishing activities by establishing conditions for the use and structure of fishing gear and restrictions on access to fishing areas; (21) 'fishing effort' means the product of the capacity and the activity of a fishing vessel; for a group of fishing vessels it is the sum of the fishing effort of all vessels in the group; (22) 'Member State having a direct management interest' means a Member State which has an interest consisting of either fishing opportunities or a fishery taking place in the exclusive economic zone of the Member State concerned, or, in the Mediterranean Sea, a traditional fishery on the high seas; (23) 'transferable fishing concession' means a revocable user entitlement to a specific part of fishing opportunities allocated to a Member State or established in a management plan adopted by a Member State in accordance with Article 19 of Council Regulation (EC) No 1967/2006 (18), which the holder may transfer; (24) 'fishing capacity' means a vessel's tonnage in GT (Gross Tonnage) and its power in kW (Kilowatt) as defined in Articles 4 and 5 of Council Regulation (EEC) No 2930/86 (19); (25) 'aquaculture' means the rearing or cultivation of aquatic organisms using techniques designed to increase the production of the organisms in question beyond the natural capacity of the environment, where the organisms remain the property of a natural or legal person throughout the rearing and culture stage, up to and including harvesting; (26) 'fishing licence' means a licence as defined in point (9) of Article 4 of Council Regulation (EC) No 1224/2009 (20); (27) 'fishing authorisation' means an authorisation as defined in point (10) of Article 4 of Regulation (EC) No 1224/2009; (28) 'fishing activity' means searching for fish, shooting, setting, towing, hauling of a fishing gear, taking catch on board, transhipping, retaining on board, processing on board, transferring, caging, fattening and landing of fish and fishery products; (29) 'fishery products' means aquatic organisms resulting from any fishing activity or products derived therefrom; (30) 'operator' means the natural or legal person who operates or holds any undertaking carrying out any of the activities related to any stage of production, processing, marketing, distribution and retail chains of fisheries and aquaculture products; (31) 'serious infringement' means an infringement that is defined as such in relevant Union law, including in Article 42(1) of Council Regulation (EC) No 1005/2008 (21) and in Article 90(1) of Regulation (EC) No 1224/2009; (32) 'end-user of scientific data' means a body with a research or management interest in the scientific analysis of data in the fisheries sector; (33) 'surplus of allowable catch' means that part of the allowable catch which a coastal State does not harvest, resulting in an overall exploitation rate for individual stocks that remains below levels at which stocks are capable of restoring themselves and maintaining populations of harvested species above desired levels based on the best available scientific advice; (34) 'aquaculture products' means aquatic organisms at any stage of their life cycle resulting from any aquaculture activity or products derived therefrom; (35) 'spawning stock biomass' means an estimate of the mass of the fish of a particular stock that reproduces at a defined time, including both males and females and fish that reproduce viviparously; (36) 'mixed fisheries' means fisheries in which more than one species is present and where different species are likely to be caught in the same fishing operation; (37) 'sustainable fisheries partnership agreement' means an international agreement concluded with a third state for the purpose of obtaining access to waters and resources in order to sustainably exploit a share of the surplus of marine biological resources, in exchange for financial compensation from the Union, which may include sectoral support. 2. For the purposes of this Regulation, the following geographical definitions of geographical areas shall apply: (a) 'North Sea' means ICES zones (22) IIIa and IV; (b) 'Baltic Sea' means ICES zones IIIb, IIIc and IIId; (c) 'North Western waters' means ICES zones V (excluding Va and only Union waters of Vb), VI and VII; (d) 'South Western waters' means ICES zones VIII, IX and X (waters around Azores), and CECAF zones (23) 34.1.1, 34.1.2 and 34.2.0 (waters around Madeira and the Canary Islands); (e) 'Mediterranean Sea' means Maritime Waters of the Mediterranean to the East of line 5\u00b036\u2032 West; (f) 'Black Sea' means the GFCM (General Fisheries Commission for the Mediterranean) geographical sub-area as defined in Resolution GFCM/33/2009/2. PART II ACCESS TO WATERS Article 5 General rules on access to waters 1. Union fishing vessels shall have equal access to waters and resources in all Union waters other than those referred to in paragraphs 2 and 3, subject to the measures adopted under Part III. 2. In the waters up to 12 nautical miles from baselines under their sovereignty or jurisdiction, Member States shall be authorised, until 31 December 2022, to restrict fishing to fishing vessels that traditionally fish in those waters from ports on the adjacent coast, without prejudice to the arrangements for Union fishing vessels flying the flag of other Member States under existing neighbourhood relations between Member States and the arrangements contained in Annex I, fixing for each Member State the geographical zones within the coastal bands of other Member States where fishing activities are pursued and the species concerned. Member States shall inform the Commission of the restrictions put in place under this paragraph. 3. In the waters up to 100 nautical miles from the baselines of the Union outermost regions referred to in the first paragraph of Article 349 of the Treaty, the Member States concerned shall be authorised, until 31 December 2022, to restrict fishing to vessels registered in the ports of those territories. Such restrictions shall not apply to Union vessels that traditionally fish in those waters, in so far as those vessels do not exceed the fishing effort traditionally exerted. Member States shall inform the Commission of the restrictions put in place under this paragraph. 4. The measures which are to apply after the expiry of the arrangements set out in paragraphs 2 and 3 shall be adopted by 31 December 2022. PART III MEASURES FOR THE CONSERVATION AND SUSTAINABLE EXPLOITATION OF MARINE BIOLOGICAL RESOURCES TITLE I Conservation measures Article 6 General provisions 1. For the purpose of achieving the objectives of the CFP in respect of the conservation and sustainable exploitation of marine biological resources as set out in Article 2, the Union shall adopt conservation measures as set out in Article 7. 2. When applying this Regulation, the Commission shall consult the relevant advisory bodies and the relevant scientific bodies. Conservation measures shall be adopted taking into account available scientific, technical and economic advice, including, where relevant, reports drawn up by STECF and other advisory bodies, advice received from Advisory Councils and joint recommendations made by Member States pursuant to Article 18. 3. Member States may cooperate with one another for the purpose of adopting measures pursuant to Articles 11, 15 and 18. 4. Member States shall coordinate with one another before adopting national measures pursuant to Article 20(2). 5. In specific cases, in particular as regards the Mediterranean region, Member States may be empowered to adopt legally binding acts in the area of the CFP, including conservation measures. Article 18 shall apply, where appropriate. Article 7 Types of conservation measures 1. Measures for the conservation and sustainable exploitation of marine biological resources may include, inter alia, the following: (a) multiannual plans under Articles 9 and 10; (b) targets for the conservation and sustainable exploitation of stocks and related measures to minimise the impact of fishing on the marine environment; (c) measures to adapt the fishing capacity of fishing vessels to available fishing opportunities; (d) incentives, including those of an economic nature, such as fishing opportunities, to promote fishing methods that contribute to more selective fishing, to the avoidance and reduction, as far as possible, of unwanted catches, and to fishing with low impact on the marine ecosystem and fishery resources; (e) measures on the fixing and allocation of fishing opportunities; (f) measures to achieve the objectives of Article 15; (g) minimum conservation reference sizes; (h) pilot projects on alternative types of fishing management techniques and on gears that increase selectivity or that minimise the negative impact of fishing activities on the marine environment; (i) measures necessary for compliance with obligations under Union environmental legislation adopted pursuant to Article 11; (j) technical measures as referred to in paragraph 2. 2. Technical measures may include, inter alia, the following: (a) characteristics of fishing gears and rules concerning their use; (b) specifications on the construction of fishing gear, including: (i) modifications or additional devices to improve selectivity or to minimise the negative impact on the ecosystem; (ii) modifications or additional devices to reduce the incidental capture of endangered, threatened and protected species, as well as to reduce other unwanted catches; (c) limitations or prohibitions on the use of certain fishing gears, and on fishing activities, in certain areas or periods; (d) requirements for fishing vessels to cease operating in a defined area for a defined minimum period in order to protect temporary aggregations of endangered species, spawning fish, fish below minimum conservation reference size, and other vulnerable marine resources; (e) specific measures to minimise the negative impact of fishing activities on marine biodiversity and marine ecosystems, including measures to avoid and reduce, as far as possible, unwanted catches. Article 8 Establishment of fish stock recovery areas 1. The Union shall, while taking due account of existing conservation areas, endeavour to establish protected areas due to their biological sensitivity, including areas where there is clear evidence of heavy concentrations of fish below minimum conservation reference size and of spawning grounds. In such areas fishing activities may be restricted or prohibited in order to contribute to the conservation of living aquatic resources and marine ecosystems. The Union shall continue to give additional protection to existing biologically sensitive areas. 2. For those purposes, Member States shall identify, where possible, suitable areas which may form part of a coherent network and shall prepare, where appropriate, joint recommendations in accordance with Article 18(7) with a view to the Commission submitting a proposal in accordance with the Treaty. 3. The Commission may be empowered in a multiannual plan to establish such biologically sensitive protected areas. Article 18(1) to (6) shall apply. The Commission shall report regularly to the European Parliament and to the Council on protected areas. TITLE II Specific measures Article 9 Principles and objectives of multiannual plans 1. Multiannual plans shall be adopted as a priority, based on scientific, technical and economic advice, and shall contain conservation measures to restore and maintain fish stocks above levels capable of producing maximum sustainable yield in accordance with Article 2(2). 2. Where targets relating to the maximum sustainable yield as referred to in Article 2(2) cannot be determined, owing to insufficient data, the multiannual plans shall provide for measures based on the precautionary approach, ensuring at least a comparable degree of conservation of the relevant stocks. 3. Multiannual plans shall cover either: (a) single species; or (b) in the case of mixed fisheries or where the dynamics of stocks relate to one another, fisheries exploiting several stocks in a relevant geographical area, taking into account knowledge about the interactions between fish stocks, fisheries and marine ecosystems. 4. The measures to be included in multiannual plans, and the calendar for implementing them, shall be proportionate to the objectives and targets pursued and to the time-frame envisaged. Before measures are included in the multiannual plans, account shall be taken of their likely economic and social impact. 5. Multiannual plans may contain specific conservation objectives and measures based on the ecosystem approach in order to address the specific problems of mixed fisheries in relation to the achievement of the objectives set out in Article 2(2) for the mixture of stocks covered by the plan in cases where scientific advice indicates that increases in selectivity cannot be achieved. Where necessary, the multiannual plan shall include specific alternative conservation measures, based on the ecosystem approach, for some of the stocks that it covers. Article 10 Content of multiannual plans 1. As appropriate and without prejudice to the respective competences under the Treaty, a multiannual plan shall include: (a) the scope, in terms of stocks, fishery and the area to which the multiannual plan shall be applied; (b) objectives that are consistent with the objectives set out in Article 2 and with the relevant provisions of Articles 6 and 9; (c) quantifiable targets such as fishing mortality rates and/or spawning stock biomass; (d) clear time-frames to reach the quantifiable targets; (e) conservation reference points consistent with the objectives set out in Article 2; (f) objectives for conservation and technical measures to be taken in order to achieve the targets set out in Article 15, and measures designed to avoid and reduce, as far as possible, unwanted catches; (g) safeguards to ensure that quantifiable targets are met, as well as remedial action, where needed, including for situations where the deteriorating quality of data or non-availability put the sustainability of the stock at risk. 2. A multiannual plan may also include: (a) other conservation measures, in particular measures to gradually eliminate discards, taking into account the best available scientific advice, or to minimise the negative impact of fishing on the ecosystem, to be further specified, where appropriate, in accordance with Article 18; (b) quantifiable indicators for periodic monitoring and assessment of progress in achieving the targets of the multiannual plan; (c) where appropriate, specific objectives for the freshwater part of the life cycle of anadromous and catadromous species. 3. A multiannual plan shall provide for its revision after an initial ex-post evaluation, in particular to take account of changes in scientific advice. Article 11 Conservation measures necessary for compliance with obligations under Union environmental legislation 1. Member States are empowered to adopt conservation measures not affecting fishing vessels of other Member States that are applicable to waters under their sovereignty or jurisdiction and that are necessary for the purpose of complying with their obligations under Article 13(4) of Directive 2008/56/EC, Article 4 of Directive 2009/147/EC or Article 6 of Directive 92/43/EEC, provided that those measures are compatible with the objectives set out in Article 2 of this Regulation, meet the objectives of the relevant Union legislation that they intend to implement, and are at least as stringent as measures under Union law. 2. Where a Member State (\"the initiating Member State\") considers that measures need to be adopted for the purpose of complying with the obligations referred to in paragraph 1 and other Member States have a direct management interest in the fishery to be affected by such measures, the Commission shall be empowered to adopt such measures, upon request, by means of delegated acts in accordance with Article 46. For this purpose, Article 18(1) to (4) and (6) shall apply mutatis mutandis. 3. The initiating Member State shall provide the Commission and the other Member States having a direct management interest with relevant information on the measures required, including their rationale, scientific evidence in support and details on their practical implementation and enforcement. The initiating Member State and the other Member States having a direct management interest may submit a joint recommendation, as referred to in Article 18(1), within six months from the provision of sufficient information. The Commission shall adopt the measures, taking into account any available scientific advice, within three months from receipt of a complete request. If not all Member States succeed in agreeing on a joint recommendation to be submitted to the Commission in accordance with the first subparagraph within the deadline set therein, or if the joint recommendation is deemed not to be compatible with the requirements referred to in paragraph 1, the Commission may submit a proposal in accordance with the Treaty. 4. By way of derogation from paragraph 3, in the absence of a joint recommendation referred to in paragraph 3, in cases of urgency, the Commission shall adopt the measures. The measures to be adopted in a case of urgency shall be limited to those in the absence of which the achievement of the objectives associated with the establishment of the conservation measures in accordance with the Directives referred to in paragraph 1 and the Member State's intentions, is in jeopardy. 5. The measures referred to in paragraph 4 shall apply for a maximum period of 12 months which may be extended for a maximum period of 12 months where the conditions provided for in that paragraph continue to exist. 6. The Commission shall facilitate cooperation between the Member State concerned and the other Member States having a direct management interest in the fishery in the process of implementation and enforcement of the measures adopted under paragraphs 2, 3 and 4. Article 12 Commission measures in case of a serious threat to marine biological resources 1. On duly justified imperative grounds of urgency relating to a serious threat to the conservation of marine biological resources or to the marine ecosystem based on evidence, the Commission, at the reasoned request of a Member State or on its own initiative, may, in order to alleviate that threat, adopt immediately applicable implementing acts applicable for a maximum period of six months in accordance with the procedure referred to in Article 47(3). 2. The Member State shall communicate the request referred to in paragraph 1 simultaneously to the Commission, to other Member States and to the Advisory Councils concerned. The other Member States and the Advisory Councils may submit their written comments within seven working days of the receipt of the notification. The Commission shall take a decision within 15 working days of the receipt of the request referred to in paragraph 1. 3. Before expiry of the initial period of application of immediately applicable implementing acts referred to in paragraph 1, the Commission may, where the conditions under paragraph 1 are complied with, adopt immediately applicable implementing acts extending the application of such emergency measure for a maximum period of six months with immediate effect. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 47(3). Article 13 Member State emergency measures 1. On the basis of evidence of a serious threat to the conservation of marine biological resources or to the marine ecosystem relating to fishing activities in waters falling under the sovereignty or jurisdiction of a Member State that require immediate action, that Member State may adopt emergency measures to alleviate the threat. Such measures shall be compatible with the objectives set out in Article 2 and no less stringent than those provided for in Union law. Such measures shall apply for a maximum period of three months. 2. Where emergency measures to be adopted by a Member State are liable to affect fishing vessels of other Member States, such measures shall be adopted only after consulting the Commission, the relevant Member States and the relevant Advisory Councils on a draft of the measures accompanied by an explanatory memorandum. The consulting Member State may set a reasonable deadline for the consultation which shall, however, not be shorter than one month. 3. Where the Commission considers that a measure adopted under this Article does not comply with the conditions set out in paragraph 1, it may, subject to providing relevant reasons, request that the Member State concerned amend or repeal that measure. Article 14 Avoidance and minimisation of unwanted catches 1. In order to facilitate the introduction of the obligation to land all catches in the respective fishery in accordance with Article 15 (\"the landing obligation\"), Member States may conduct pilot projects, based on the best available scientific advice and taking into account the opinions of the relevant Advisory Councils, with the aim of fully exploring all practicable methods for the avoidance, minimisation and elimination of unwanted catches in a fishery. 2. Member States may produce a \"discard atlas\" showing the level of discards in each of the fisheries which are covered by Article 15(1). Article 15 Landing obligation 1. All catches of species which are subject to catch limits and, in the Mediterranean, also catches of species which are subject to minimum sizes as defined in Annex III to Regulation (EC) No 1967/2006, caught during fishing activities in Union waters or by Union fishing vessels outside Union waters in waters not subject to third countries' sovereignty or jurisdiction, in the fisheries and geographical areas listed below shall be brought and retained on board the fishing vessels, recorded, landed and counted against the quotas where applicable, except when used as live bait, in accordance with the following time-frames: (a) From 1 January 2015 at the latest: \u2014 small pelagic fisheries (i.e. fisheries for mackerel, herring, horse mackerel, blue whiting, boarfish, anchovy, argentine, sardine, sprat); \u2014 large pelagic fisheries (i.e. fisheries for bluefin tuna, swordfish, albacore tuna, bigeye tuna, blue and white marlin); \u2014 fisheries for industrial purposes (inter alia, fisheries for capelin, sandeel and Norwegian pout); \u2014 fisheries for salmon in the Baltic Sea. (b) From 1 January 2015 at the latest for species which define the fisheries and from 1 January 2017 at the latest for all other species in fisheries in Union waters of the Baltic Sea for species subject to catch limits other than those covered by point (a). (c) From 1 January 2016 at the latest for the species which define the fisheries and from 1 January 2019 at the latest for all other species in: (i) the North Sea \u2014 fisheries for cod, haddock, whiting, saithe; \u2014 fisheries for Norway lobster; \u2014 fisheries for common sole and plaice; \u2014 fisheries for hake; \u2014 fisheries for Northern prawn; (ii) North Western waters \u2014 fisheries for cod, haddock, whiting, saithe; \u2014 fisheries for Norway lobster; \u2014 fisheries for common sole and plaice; \u2014 fisheries for hake; (iii) South Western waters \u2014 fisheries for Norway lobster; \u2014 fisheries for common sole and plaice; \u2014 fisheries for hake; (iv) other fisheries for species subject to catch limits. (d) From 1 January 2017 at the latest for species which define the fisheries and from 1 January 2019 at the latest for all other species in fisheries not covered by point (a) in the Mediterranean, in the Black Sea and in all other Union waters and in non-Union waters not subject to third countries' sovereignty or jurisdiction. 2. Paragraph 1 shall be without prejudice to the Union's international obligations. The Commission shall be empowered to adopt delegated acts, in accordance with Article 46, for the purpose of implementing such international obligations into Union law, including, in particular, derogations from the landing obligation under this Article. 3. Where all the Member States having a direct management interest in a particular fishery agree that the landing obligation should apply to species other than those listed in paragraph 1, they may submit a joint recommendation for the purpose of extending the application of the landing obligation to such other species. For this purpose, Article 18(1) to (6) shall apply mutatis mutandis. Where such a joint recommendation is submitted, the Commission shall be empowered to adopt delegated acts, in accordance with Article 46, containing such measures. 4. The landing obligation referred to in paragraph 1 shall not apply to: (a) species in respect of which fishing is prohibited and which are identified as such in a Union legal act adopted in the area of the CFP; (b) species for which scientific evidence demonstrates high survival rates, taking into account the characteristics of the gear, of the fishing practices and of the ecosystem; (c) catches falling under de minimis exemptions. 5. Details of the implementation of the landing obligation referred to in paragraph 1 shall be specified in multiannual plans referred to in Articles 9 and 10 and, where relevant, further specified in accordance with Article 18, including: (a) specific provisions regarding fisheries or species covered by the landing obligation referred to in paragraph 1; (b) the specification of exemptions to the landing obligation of species referred to in point (b) of paragraph 4; (c) provisions for de minimis exemptions of up to 5 % of total annual catches of all species subject to the landing obligation referred to in paragraph 1. The de minimis exemption shall apply in the following cases: (i) where scientific evidence indicates that increases in selectivity are very difficult to achieve; or (ii) to avoid disproportionate costs of handling unwanted catches, for those fishing gears where unwanted catches per fishing gear do not represent more than a certain percentage, to be established in a plan, of total annual catch of that gear. Catches under the provisions referred to in this point shall not be counted against the relevant quotas; however, all such catches shall be fully recorded. For a transitional period of four years, the percentage of the total annual catches referred to in this point shall increase: (i) by two percentage points in the first two years of application of the landing obligation; and (ii) by one percentage point in the subsequent two years; (d) provisions on documentation of catches; (e) where appropriate, the fixing of minimum conservation reference sizes in accordance with paragraph 10. 6. Where no multiannual plan, or no management plan in accordance with Article 18 of Regulation (EC) No 1967/2006, is adopted for the fishery in question, the Commission shall be empowered to adopt, in accordance with Article 18 of this Regulation, delegated acts in accordance with Article 46 of this Regulation, laying down on a temporary basis and for a period of no more than three years a specific discard plan containing the specifications referred to in points (a) to (e) of paragraph 5 of this Article. Member States may cooperate, in accordance with Article 18 of this Regulation, in the drawing up of such a plan with a view to the Commission adopting such acts or submitting a proposal in accordance with the ordinary legislative procedure. 7. Where no measures have been adopted for the purpose of specifying the de minimis exemption either in a multiannual plan in accordance with paragraph 5 or in a specific discard plan in accordance with paragraph 6, the Commission shall adopt delegated acts, in accordance with Article 46, setting the de minimis exemption referred to in point (c) of paragraph 4 which shall, subject to the conditions set out in point (c)(i) or (ii) of paragraph 5, amount to no more than 5 % of total annual catches of all species to which the landing obligation applies under paragraph 1. That de minimis exemption shall be adopted so as to apply from the date of application of the relevant landing obligation. 8. By way of derogation from the obligation to count catches against the relevant quotas in accordance with paragraph 1, catches of species that are subject to the landing obligation and that are caught in excess of quotas of the stocks in question, or catches of species in respect of which the Member State has no quota, may be deducted from the quota of the target species provided that they do not exceed 9 % of the quota of the target species. This provision shall only apply where the stock of the non-target species is within safe biological limits. 9. For stocks subject to the landing obligation, Member States may use a year-to-year flexibility of up to 10 % of their permitted landings. For this purpose, a Member State may allow landing of additional quantities of the stock that is subject to the landing obligation provided that such quantities do not exceed 10 % of the quota allocated to that Member State. Article 105 of Regulation (EC) No 1224/2009 shall apply. 10. Minimum conservation reference sizes may be established with the aim of ensuring the protection of juveniles of marine organisms. 11. For the species subject to the landing obligation as specified in paragraph 1, the use of catches of species below the minimum conservation reference size shall be restricted to purposes other than direct human consumption, including fish meal, fish oil, pet food, food additives, pharmaceuticals and cosmetics. 12. For species that are not subject to the landing obligation as specified in paragraph 1, the catches of species below the minimum conservation reference size shall not be retained on board, but shall be returned immediately to the sea. 13. For the purpose of monitoring compliance with the landing obligation, Member States shall ensure detailed and accurate documentation of all fishing trips and adequate capacity and means, such as observers, closed-circuit television (CCTV) and others. In doing so, Member States shall respect the principle of efficiency and proportionality. Article 16 Fishing opportunities 1. Fishing opportunities allocated to Member States shall ensure relative stability of fishing activities of each Member State for each fish stock or fishery. The interests of each Member State shall be taken into account when new fishing opportunities are allocated. 2. When the landing obligation in respect of a fish stock is introduced, fishing opportunities shall be fixed taking into account the change from fixing fishing opportunities that reflect landings to fixing fishing opportunities that reflect catches, on the basis of the fact that, for the first and subsequent years, discarding of that stock will no longer be allowed. 3. Where new scientific evidence shows that there is a significant disparity between the fishing opportunities that have been fixed for a specific stock and the actual state of that stock, Member States having a direct management interest may submit a reasoned request to the Commission for it to submit a proposal to alleviate that disparity, while respecting the objectives set out in Article 2(2). 4. Fishing opportunities shall be fixed in accordance with the objectives set out in Article 2(2) and shall comply with quantifiable targets, time-frames and margins established in accordance with Article 9(2) and points (b) and (c) of Article 10(1). 5. Measures on the fixing and allocation of fishing opportunities available to third countries in Union waters shall be established in accordance with the Treaty. 6. Each Member State shall decide how the fishing opportunities that are allocated to it, and which are not subject to a system of transferable fishing concessions, may be allocated to vessels flying its flag (e.g. by creating individual fishing opportunities). It shall inform the Commission of the allocation method. 7. For the allocation of fishing opportunities pertaining to mixed fisheries, Member States shall take account of the likely catch composition of vessels participating in such fisheries. 8. Member States may, after notifying the Commission, exchange all or part of the fishing opportunities allocated to them. Article 17 Criteria for the allocation of fishing opportunities by Member States When allocating the fishing opportunities available to them, as referred to in Article 16, Member States shall use transparent and objective criteria including those of an environmental, social and economic nature. The criteria to be used may include, inter alia, the impact of fishing on the environment, the history of compliance, the contribution to the local economy and historic catch levels. Within the fishing opportunities allocated to them, Member States shall endeavour to provide incentives to fishing vessels deploying selective fishing gear or using fishing techniques with reduced environmental impact, such as reduced energy consumption or habitat damage. TITLE III Regionalisation Article 18 Regional cooperation on conservation measures 1. Where the Commission has been granted powers, including in a multiannual plan established pursuant to Articles 9 and 10, as well as in cases provided for in Articles 11 and 15(6), to adopt measures by means of delegated or implementing acts in respect of a Union conservation measure applying to a relevant geographical area, Member States having a direct management interest affected by those measures may, within a deadline to be stipulated in the relevant conservation measure and/or multiannual plan, agree to submit joint recommendations for achieving the objectives of the relevant Union conservation measures, the multiannual plans or the specific discard plans. The Commission shall not adopt any such delegated or implementing acts before the expiry of the deadline for submission of joint recommendations by the Member States. 2. For the purpose of paragraph 1, Member States having a direct management interest affected by the measures referred to in paragraph 1 shall cooperate with one another in formulating joint recommendations. They shall also consult the relevant Advisory Councils. The Commission shall facilitate the cooperation between Member States, including, where necessary, by ensuring that a scientific contribution is obtained from the relevant scientific bodies. 3. Where a joint recommendation is submitted under paragraph 1, the Commission may adopt those measures by means of delegated or implementing acts, provided that such recommendation is compatible with the relevant conservation measure and/or multiannual plan. 4. Where the conservation measure applies to a specific fish stock shared with third countries and managed by multilateral fisheries organisations or under bilateral or multilateral agreements, the Union shall endeavour to agree with the relevant partners the measures that are necessary to achieve the objectives set out in Article 2. 5. Member States shall ensure that the joint recommendations on conservation measures to be adopted pursuant to paragraph 1 are based on the best available scientific advice and fulfil all of the following requirements: (a) they are compatible with the objectives set out in Article 2; (b) they are compatible with the scope and objectives of the relevant conservation measure; (c) they are compatible with the scope and meet the objectives and quantifiable targets set out in a relevant multiannual plan effectively; (d) they are at least as stringent as measures under Union law. 6. If all Member States do not succeed in agreeing on joint recommendations to be submitted to the Commission in accordance with paragraph 1 within a set deadline or if the joint recommendations on conservation measures are deemed not to be compatible with the objectives and quantifiable targets of the conservation measures in question, the Commission may submit a proposal for appropriate measures in accordance with the Treaty. 7. In addition to the cases referred to in paragraph 1, Member States having a direct management interest in a fishery in a defined geographical area may also make joint recommendations to the Commission on measures to be proposed or adopted by the Commission. 8. As a supplementary or alternative method of regional cooperation, Member States will be empowered, in a Union conservation measure that applies to a relevant geographical area, including in a multiannual plan established pursuant to Articles 9 and 10, to adopt within a set deadline measures further specifying that conservation measure. The Member States concerned shall closely cooperate in the adoption of such measures. Paragraphs 2, 4 and 5 of this Article shall apply mutatis mutandis. The Commission shall be associated and its comments shall be taken into account. Member States shall only adopt their respective national measures if an agreement on the content of those measures has been reached by all the Member States concerned. Where the Commission considers that a Member State's measure does not comply with the conditions set out in the relevant conservation measure, it may, subject to providing relevant reasons, request that the Member State concerned amend or repeal that measure. TITLE IV National measures Article 19 Member State measures applicable to fishing vessels flying their flag or to persons established in their territory 1. A Member State may adopt measures for the conservation of fish stocks in Union waters provided that those measures fulfil all of the following requirements: (a) they apply solely to fishing vessels flying the flag of that Member State or, in the case of fishing activities which are not conducted by a fishing vessel, to persons established in that part of its territory to which the Treaty applies; (b) they are compatible with the objectives set out in Article 2; (c) they are at least as stringent as measures under Union law. 2. A Member State shall, for control purposes, inform the other Member States concerned of provisions adopted pursuant to paragraph 1. 3. Member States shall make publicly available appropriate information concerning the measures adopted in accordance with this Article. Article 20 Member State measures within the 12 nautical mile zone 1. A Member State may take non-discriminatory measures for the conservation and management of fish stocks and the maintenance or improvement of the conservation status of marine ecosystems within 12 nautical miles of its baselines provided that the Union has not adopted measures addressing conservation and management specifically for that area or specifically addressing the problem identified by the Member State concerned. The Member State measures shall be compatible with the objectives set out in Article 2 and shall be at least as stringent as measures under Union law. 2. Where conservation and management measures to be adopted by a Member State are liable to affect fishing vessels of other Member States, such measures shall be adopted only after consulting the Commission, the relevant Member States and the relevant Advisory Councils on a draft of the measures, which shall be accompanied by an explanatory memorandum that demonstrates, inter alia, that those measures are non-discriminatory. For the purpose of such consultation, the consulting Member State may set a reasonable deadline, which shall, however, not be shorter than two months. 3. Member States shall make publicly available appropriate information concerning the measures adopted in accordance with this Article. 4. Where the Commission considers that a measure adopted under this Article does not comply with the conditions set out in paragraph 1, it may, subject to providing relevant reasons, request that the Member State concerned amends or repeals the relevant measure. PART IV MANAGEMENT OF FISHING CAPACITY Article 21 Establishment of systems of transferable fishing concessions Member States may establish a system of transferable fishing concessions. Member States having such a system shall establish and maintain a register of transferable fishing concessions. Article 22 Adjustment and management of fishing capacity 1. Member States shall put in place measures to adjust the fishing capacity of their fleet to their fishing opportunities over time, taking into account trends and based on best scientific advice, with the objective of achieving a stable and enduring balance between them. 2. In order to achieve the objective referred to in paragraph 1, Member States shall send to the Commission, by 31 May each year, a report on the balance between the fishing capacity of their fleets and their fishing opportunities. To facilitate a common approach across the Union, that report shall be prepared in accordance with common guidelines which may be developed by the Commission indicating the relevant technical, social and economic parameters. The report shall contain the annual capacity assessment of the national fleet and of all fleet segments of the Member State. The report shall seek to identify structural overcapacity by segment and shall estimate the long-term profitability by segment. The reports shall be made publicly available. 3. With regard to the assessment referred to in the second subparagraph of paragraph 2, Member States shall base their analysis on the balance between the fishing capacity of their fleets and their fishing opportunities. Separate assessments shall be drawn up for fleets operating in the outermost regions and for vessels operating exclusively outside Union waters. 4. If the assessment clearly demonstrates that the fishing capacity is not effectively balanced with fishing opportunities, the Member State shall prepare and include in its report an action plan for the fleet segments with identified structural overcapacity. The action plan shall set out the adjustment targets and tools to achieve a balance and a clear time-frame for its implementation. On a yearly basis, the Commission shall prepare a report for the European Parliament and for the Council on the balance between the fishing capacity of the Member States' fleets and their fishing opportunities, in accordance with the guidelines referred to in the first subparagraph of paragraph 2. The report shall include action plans referred to in the first subparagraph of this paragraph. The first report shall be submitted by 31 March 2015. Failure to make the report referred to in paragraph 2, and/or failure to implement the action plan referred to in the first subparagraph of this paragraph, may result in a proportionate suspension or interruption of relevant Union financial assistance to that Member State for fleet investment in the fleet segment or segments concerned in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014\u20132020. 5. No exit from the fleet supported by public aid shall be permitted unless preceded by the withdrawal of the fishing licence and the fishing authorisations. 6. The fishing capacity corresponding to the fishing vessels withdrawn with public aid shall not be replaced. 7. Member States shall ensure that from 1 January 2014 the fishing capacity of their fleets does not exceed at any time the fishing capacity ceilings set out in Annex II. Article 23 Entry/Exit scheme 1. Member States shall manage entries into their fleets and exits from their fleets in such a way that the entry into the fleet of new capacity without public aid is compensated for by the prior withdrawal of capacity without public aid of at least the same amount. 2. The Commission may adopt implementing acts laying down implementing rules for the application of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). 3. No later than 30 December 2018, the Commission shall evaluate the Entry/Exit scheme in the light of the evolving relationship between fleet capacity and prospected fishing opportunities, and propose, where appropriate, an amendment to that scheme. Article 24 Fishing fleet registers 1. Member States shall record the information on ownership, on vessel and gear characteristics and on the activity of Union fishing vessels flying their flag that is necessary for the management of measures established under this Regulation. 2. Member States shall submit to the Commission the information referred to in paragraph 1. 3. The Commission shall maintain a Union fishing fleet register containing the information that it receives pursuant paragraph 2. It shall provide public access to the Union fishing fleet register, while ensuring that personal data is adequately protected. 4. The Commission shall adopt implementing acts, establishing technical operational requirements for the recording, format and transmission modalities of the information referred to in paragraphs 1, 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). PART V SCIENTIFIC BASE FOR FISHERIES MANAGEMENT Article 25 Data requirements for fisheries management 1. Member States shall, in accordance with the rules adopted in the area of data collection, collect biological, environmental, technical, and socio-economic data necessary for fisheries management, manage those data and make them available to end\u2013users, including bodies designated by the Commission. The acquisition and management of such data shall be eligible for funding through the European Maritime and Fisheries Fund in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014\u20132020. Those data shall, in particular, enable the assessment of: (a) the state of exploited marine biological resources; (b) the level of fishing and the impact that fishing activities have on the marine biological resources and on the marine ecosystems; and (c) the socio-economic performance of the fisheries, aquaculture and processing sectors within and outside Union waters. 2. The collection, management and use of data shall be based on the following principles: (a) accuracy and reliability, and collection in a timely manner; (b) the use of coordination mechanisms with a view to avoiding duplication of data collection for different purposes; (c) safe storage and protection of collected data in computerised databases, and their public availability where appropriate, including at aggregated level, whilst ensuring confidentiality; (d) access by the Commission, or by bodies designated by it, to the national databases and systems used for processing the collected data for the purpose of verification of the existence and quality of the data; (e) the availability in a timely manner of the relevant data and the respective methodologies by which they are obtained, for bodies with a research or management interest in the scientific analysis of data in the fisheries sector and for any interested parties, save in circumstances where protection and confidentiality are required under applicable Union law. 3. Every year, Member States shall submit to the Commission a report on the execution of their national data collection programmes and shall make it publicly available. The Commission shall assess the annual report on data collection after consulting its scientific advisory body and, where appropriate, regional fisheries management organisations (RFMOs) to which the Union is a contracting party or observer and relevant international scientific bodies. 4. Member States shall ensure the national coordination of the collection and management of scientific data for fisheries management, including socio-economic data. To this end, they shall designate a national correspondent and organise an annual national coordination meeting. The Commission shall be informed of the national coordination activities and shall be invited to the coordination meetings. 5. In close cooperation with the Commission, Member States shall coordinate their data collection activities with other Member States in the same region, and shall make every effort to coordinate their actions with third countries having sovereignty or jurisdiction over waters in the same region. 6. The collection, management and use of data shall be carried out in a cost-effective manner. 7. Failure by a Member State to collect and/or to provide data in a timely manner to end-users may result in a proportionate suspension or interruption of relevant Union financial assistance to that Member State, in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014\u20132020. Article 26 Consulting scientific bodies The Commission shall consult appropriate scientific bodies. STECF shall be consulted, where appropriate, on matters pertaining to the conservation and management of living marine resources, including biological, economic, environmental, social and technical considerations. Consultations of scientific bodies shall take into account the proper management of public funds, with the aim of avoiding duplication of work by such bodies. Article 27 Research and Scientific Advice 1. Member States shall carry out fisheries and aquaculture research and innovation programmes. They shall coordinate their fisheries research innovation and scientific advice programmes with other Member States, in close cooperation with the Commission, in the context of the Union research and innovation frameworks, involving, where appropriate, the relevant Advisory Councils. Those activities shall be eligible for funding through the Union budget in accordance with the relevant Union legal acts. 2. Member states shall, with the involvement of the relevant stakeholders, utilising inter alia available Union financial resources and coordinating with one another, ensure availability of relevant competences and human resources to be involved in the scientific advisory process. PART VI EXTERNAL POLICY Article 28 Objectives 1. In order to ensure sustainable exploitation, management and conservation of marine biological resources and the marine environment, the Union shall conduct its external fisheries relations in accordance with its international obligations and policy objectives, as well as the objectives and principles set out in Articles 2 and 3. 2. In particular, the Union shall: (a) actively support and contribute to the development of scientific knowledge and advice; (b) improve policy coherence of Union initiatives, with particular regard to environmental, trade and development activities and strengthen consistency of actions taken in the context of development cooperation and scientific, technical and economic cooperation; (c) contribute to sustainable fishing activities that are economically viable and promote employment within the Union; (d) ensure that Union fishing activities outside Union waters are based on the same principles and standards as those applicable under Union law in the area of the CFP, while promoting a level\u2013playing field for Union operators vis-\u00e0-vis third-country operators; (e) promote and support, in all international spheres, action necessary to eradicate IUU-fishing; (f) promote the establishment and the strengthening of compliance committees of RFMOs, periodical independent performance reviews and appropriate remedial actions, including effective and dissuasive penalties, which are to be applied in a transparent and non-discriminatory manner. 3. The provisions of this Part shall be without prejudice to specific provisions adopted under Article 218 of the Treaty. TITLE I International fisheries organisations Article 29 Union activities in international fisheries organisations 1. The Union shall actively support and contribute to the activities of international organisations dealing with fisheries, including RFMOs. 2. The positions of the Union in international organisations dealing with fisheries and in RFMOs shall be based on the best available scientific advice so as to ensure that fishery resources are managed in accordance with the objectives laid down in Article 2, in particular paragraph 2 and point (c) of paragraph 5 thereof. The Union shall seek to lead the process of strengthening the performance of RFMOs so as to better enable them to conserve and manage marine living resources under their purview. 3. The Union shall actively support the development of appropriate and transparent mechanisms for the allocation of fishing opportunities. 4. The Union shall foster cooperation among RFMOs and consistency between their respective regulatory frameworks, and shall support the development of scientific knowledge and advice to ensure that their recommendations are based on such scientific advice. Article 30 Compliance with international provisions The Union shall, including through the European Fisheries Control Agency (\"the Agency\"), cooperate with third countries and international organisations dealing with fisheries, including RFMOs, to strengthen compliance with measures, especially those to combat IUU fishing, in order to ensure that measures adopted by such international organisations are strictly adhered to. TITLE II Sustainable fisheries partnership agreements Article 31 Principles and objectives of Sustainable fisheries partnership agreements 1. Sustainable fisheries partnership agreements with third countries shall establish a legal, environmental, economic and social governance framework for fishing activities carried out by Union fishing vessels in third country waters. Such frameworks may include: (a) development and support for the necessary scientific and research institutions; (b) monitoring, control and surveillance capabilities; (c) other capacity building elements concerning the development of a sustainable fisheries policy of the third country. 2. For the purpose of ensuring the sustainable exploitation of surpluses of marine biological resources, the Union shall endeavour to ensure that the Sustainable fisheries partnership agreements with third countries are of mutual benefit to the Union and to the third country concerned, including its local population and fishing industry and that they contribute to continuing the activity of Union fleets and seek to obtain an appropriate share of the available surplus, commensurate with the Union fleets' interest. 3. For the purpose of ensuring that Union vessels fishing under Sustainable fisheries partnership agreements operate, where appropriate, under similar standards to those applicable to Union fishing vessels fishing in Union waters, the Union shall endeavour to include in Sustainable fisheries partnership agreements appropriate provisions on obligations to land fish and fishery products. 4. Union fishing vessels shall only catch surplus of the allowable catch as referred to in Article 62(2) and (3) of the UNCLOS, and identified, in a clear and transparent manner, on the basis of the best available scientific advice and of the relevant information exchanged between the Union and the third country about the total fishing effort on the affected stocks by all fleets. Concerning straddling or highly migratory fish stocks, the determination of the resources available for access should take due account of scientific assessments conducted at the regional level as well as conservation and management measures adopted by relevant RFMOs. 5. Union fishing vessels shall not operate in the waters of the third country with which a Sustainable fisheries partnership agreement is in force unless they are in possession of a fishing authorisation which has been issued in accordance with that agreement. 6. The Union shall ensure that Sustainable fisheries partnership agreements include a clause concerning respect for democratic principles and human rights, which constitutes an essential element of such agreements. Those agreements shall also, to the extent possible, include: (a) a clause prohibiting the granting of more favourable conditions to other fleets fishing in those waters than those granted to Union economic actors, including conditions concerning the conservation, development and management of resources, financial arrangements, and fees and rights relating to the issuing of fishing authorisations; (b) an exclusivity clause relating to the rule provided for in paragraph 5. 7. Efforts shall be made at Union level to monitor the activities of Union fishing vessels that operate in non\u2013Union waters outside the framework of Sustainable fisheries partnership agreements. 8. Member States shall ensure that Union fishing vessels flying their flag and operating outside Union waters are in a position to provide detailed and accurate documentation of all fishing and processing activities. 9. A fishing authorisation, as referred to in paragraph 5, shall be granted to a vessel which has left the Union fishing fleet register and which has subsequently returned to it within 24 months, only if the owner of that vessel has provided to the competent authorities of the flag Member State all data required to establish that, during that period, the vessel was operating in a manner fully consistent with the standards applicable to a vessel flagged in the Union. Where the state granting the flag during the period that the vessel was off the Union fishing fleet register became recognised under Union law as a non-cooperating state with regard to combating, deterring and eliminating IUU fishing, or as a state allowing for non-sustainable exploitation of living marine resources, such fishing authorisation shall only be granted if it is established that the vessel's fishing operations ceased and the owner took immediate action to remove the vessel from the register of that state. 10. The Commission shall arrange for independent ex-ante and ex-post evaluations of each protocol to a Sustainable fisheries partnership agreement, and make them available to the European Parliament and to the Council in good time before it submits to the Council a recommendation to authorise the opening of negotiations for a successor protocol. A summary of such evaluations shall be made publicly available. Article 32 Financial assistance 1. The Union shall provide financial assistance to third countries through Sustainable fisheries partnership agreements in order to: (a) support part of the cost of access to the fisheries resources in third country waters; the part of the cost of access to the fisheries resources to be paid by Union vessel owners shall be assessed for each Sustainable fisheries partnership agreement or a Protocol to it and shall be fair, non-discriminatory and commensurate with the benefits provided through the access conditions; (b) establish the governance framework, including the development and maintenance of the necessary scientific and research institutions, promote consultation processes with interest groups, and monitoring, control and surveillance capability and other capacity building items relating to the development of a sustainable fisheries policy driven by the third country. Such financial assistance shall be conditional upon the achievement of specific results and complementary to and consistent with the development projects and programmes implemented in the third country in question. 2. Under each Sustainable fisheries partnership agreement, the financial assistance for sectoral support shall be decoupled from payments for access to fisheries resources. The Union shall require the achievement of specific results as a condition for payments under the financial assistance, and shall closely monitor progress. TITLE III Management of stocks of common interest Article 33 Principles and objectives of management of stocks of common interest to the Union and third countries and agreements on exchange and joint management 1. Where stocks of common interest are also exploited by third countries, the Union shall engage with those third countries with a view to ensuring that those stocks are managed in a sustainable manner that is consistent with this Regulation, and in particular with the objective laid down in Article 2(2). Where no formal agreement is reached, the Union shall make every effort to reach common arrangements for fishing of such stocks with a view to making the sustainable management possible, in particular, concerning the objective in Article 2(2), thereby promoting a level\u2013playing field for Union operators. 2. In order to ensure a sustainable exploitation of stocks shared with third countries and to guarantee stability of the fishing operations of its fleets, the Union shall, in accordance with UNCLOS, endeavour to establish bilateral or multilateral agreements with third countries for the joint management of stocks, including the establishment, where appropriate, of access to waters and resources and conditions for such access, the harmonisation of conservation measures and the exchange of fishing opportunities. PART VII AQUACULTURE Article 34 Promoting sustainable aquaculture 1. With a view to promoting sustainability and contributing to food security and supplies, growth and employment, the Commission shall establish non-binding Union strategic guidelines on common priorities and targets for the development of sustainable aquaculture activities. Such strategic guidelines shall take account of the relative starting positions and different circumstances throughout the Union and shall form the basis for multiannual national strategic plans, and shall aim at: (a) improving the competitiveness of the aquaculture industry and supporting its development and innovation; (b) reducing the administrative burden and making the implementation of Union law more efficient and responsive to the needs of stakeholders; (c) encouraging economic activity; (d) diversification and improvement of the quality of life in coastal and inland areas; (e) integrating aquaculture activities into maritime, coastal and inland spatial planning. 2. By 30 June 2014, Member States shall establish a multiannual national strategic plan for the development of aquaculture activities on their territory. 3. The multiannual national strategic plan shall include the Member State's objectives and the measures and the timetables necessary to achieve them. 4. Multiannual national strategic plans shall, in particular, have the following aims: (a) administrative simplification, in particular regarding evaluations and impact studies and licenses; (b) reasonable certainty for aquaculture operators in relation to access to waters and space; (c) indicators for environmental, economic and social sustainability; (d) assessment of other possible cross-border effects, especially on marine biological resources and marine ecosystems in neighbouring Member States; (e) the creation of synergies between national research programmes and collaboration between the industry and the scientific community; (f) the promotion of the competitive advantage of sustainable, high quality food; (g) the promotion of aquaculture practices and research with a view to enhancing positive effects on the environment and on the fish resources, and to reducing negative impacts, including reducing pressure on fish stocks used for feed production, and increasing resource efficiency. 5. Member States shall exchange information and best practices through an open method of coordination of the national measures contained in multiannual national strategic plans. 6. The Commission shall encourage the exchange of information and best practices among Member States and shall facilitate the coordination of national measures foreseen in the multiannual national strategic plan. PART VIII COMMON MARKET ORGANISATION Article 35 Objectives 1. A common organisation of the markets in fishery and aquaculture products (the common market organisation) shall be established to: (a) contribute to the achievement of the objectives set out in Article 2, and in particular to the sustainable exploitation of living marine biological resources; (b) enable the fishery and aquaculture industry to apply the CFP at the appropriate level; (c) strengthen the competitiveness of the Union fishery and aquaculture industry, in particular producers; (d) improve the transparency and stability of the markets, in particular as regards economic knowledge and understanding of the Union markets for fishery and aquaculture products along the supply chain, ensure that the distribution of added value along the sector's supply chain is more balanced, improve consumer information and raise awareness, by means of notification and labelling that provides comprehensible information; (e) contribute to ensuring a level\u2013playing field for all products marketed in the Union by promoting sustainable exploitation of fisheries resources; (f) contribute to ensuring that consumers have a diverse supply of fishery and aquaculture products; (g) provide the consumer with verifiable and accurate information regarding the origin of the product and its mode of production, in particular through marking and labelling. 2. The common market organisation shall apply to the fishery and aquaculture products listed in Annex I to Regulation (EU) No 1379/2013 of the European Parliament and of the Council (24), which are marketed in the Union. 3. The common market organisation shall include, in particular: (a) the organisation of the industry including market stabilization measures; (b) the production and marketing plans of fishery and aquaculture producer organisations; (c) common marketing standards; (d) consumer information. PART IX CONTROL AND ENFORCEMENT Article 36 Objectives 1. Compliance with the CFP rules shall be ensured through an effective Union fisheries control system, including the fight against IUU fishing. 2. Control and enforcement of the CFP shall in particular be based on and shall include the following: (a) a global, integrated and common approach; (b) cooperation and coordination between Member States, the Commission and the Agency; (c) cost-efficiency and proportionality; (d) the use of efficient control technologies for the availability and quality of data on fisheries; (e) a Union framework for control, inspection and enforcement; (f) a risk-based strategy focused on systematic and automated cross-checks of all available relevant data; (g) the development of a culture of compliance and co-operation among all operators and fishermen. The Union shall adopt appropriate measures with regard to third countries which allow non-sustainable fishing. 3. Member States shall adopt appropriate measures for ensuring control, inspection and enforcement of activities carried out within the scope of the CFP, including the establishment of effective, proportionate and dissuasive penalties. Article 37 Expert group on compliance 1. An expert group on compliance shall be established by the Commission to assess, facilitate and strengthen the implementation of, and compliance with, the obligations under the Union fisheries control system. 2. The expert group on compliance shall be composed of representatives of the Commission and the Member States. At the request of the European Parliament, the Commission may invite the European Parliament to send experts to attend meetings of the expert group. The Agency may assist the expert group on compliance meetings as an observer. 3. The expert group shall in particular: (a) regularly review issues of compliance and implementation under Union fisheries control system and identify possible difficulties of common interest in implementation of the CFP rules; (b) formulate advice in relation to the implementation of the CFP rules, including prioritisation of Union financial assistance; and (c) exchange information on control and inspection activities, including the fight against IUU fishing. 4. The European Parliament and the Council shall be kept fully informed on a regular basis by the expert group on compliance activities referred to in paragraph 3. Article 38 Pilot projects on new control technologies and data management systems The Commission and the Member States may carry out pilot projects on new control technologies and systems for data management. Article 39 Contribution to control, inspection, enforcement and data collection costs Member States may require their operators to contribute proportionally to the operational costs of implementing the Union fisheries control system and of data collection. PART X FINANCIAL INSTRUMENTS Article 40 Objectives Union financial assistance may be granted to contribute to the achievement of the objectives set out in Article 2. Article 41 Conditions for financial assistance to Member States 1. Subject to the conditions to be specified in the applicable Union legal acts, Union financial assistance to Member States shall be conditional upon compliance with the CFP rules by Member States. 2. Non\u2013compliance by Member States with the CFP rules may result in the interruption or suspension of payments or in the application of a financial correction to Union financial assistance under the CFP. Such measures shall be proportionate to the nature, gravity, duration and repetition of the non\u2013compliance. Article 42 Conditions for financial assistance to operators 1. Subject to the conditions to be specified in the applicable Union legal acts, Union financial assistance to operators shall be conditional upon compliance with the CFP rules by operators. 2. Subject to specific rules to be adopted, serious infringements by operators of the CFP rules shall result in temporary or permanent bans on access to the Union financial assistance and/or the application of financial reductions. Such measures, taken by the Member State, shall be dissuasive, effective and proportionate to the nature, gravity, duration and repetition of serious infringements. 3. Member States shall ensure that Union financial assistance is granted only if no penalties for serious infringements have been imposed on the operator concerned within a period of one year prior to the date of application for Union financial assistance. PART XI ADVISORY COUNCILS Article 43 Establishment of Advisory Councils 1. Advisory Councils shall be established for each of the geographical areas or fields of competence set out in Annex III, in order to promote a balanced representation of all stakeholders in accordance with Article 45(1) and to contribute to the achievement of the objectives set out in Article 2. 2. In particular, the following new Advisory Councils shall be established, in accordance with Annex III: (a) an Advisory Council for the outermost regions, divided into three sections for each of the following sea basins: West Atlantic, East Atlantic and Indian Ocean; (b) an Advisory Council for aquaculture; (c) an Advisory Council for markets; (d) an Advisory Council for the Black Sea. 3. Each Advisory Council shall establish its rules of procedure. Article 44 Tasks of Advisory Councils 1. When applying this Regulation, the Commission shall, where relevant, consult the Advisory Councils. 2. Advisory Councils may: (a) submit recommendations and suggestions on matters relating to the management of fisheries and the socio-economic and conservation aspects of fisheries and aquaculture to the Commission and to the Member State concerned, and, in particular, recommendations on how to simplify rules on fisheries management; (b) inform the Commission and Member States of problems relating to the management and the socio-economic and conservation aspects of fisheries and, where appropriate, of aquaculture in their geographical area or field of competence and propose solutions to overcome those problems; (c) contribute, in close cooperation with scientists, to the collection, supply and analysis of data necessary for the development of conservation measures. If an issue is of common interest to two or more Advisory Councils, they shall coordinate their positions with a view to adopting joint recommendations on that issue. 3. Advisory Councils shall be consulted on joint recommendations pursuant to Article 18. They may also be consulted by the Commission and by Member States in respect of other measures. Their advice shall be taken into account. Those consultations shall be without prejudice to the consultation of STECF or other scientific bodies. The opinions of the Advisory Councils may be submitted to all Member States concerned and to the Commission. 4. The Commission and, where relevant, the Member State concerned shall reply within two months to any recommendation, suggestion or information received pursuant to paragraph 1. Where the final measures that are adopted diverge from the Advisory Councils' opinions, recommendations and suggestions received pursuant to paragraph 1, the Commission or the Member State concerned shall state detailed reasons for the divergence. Article 45 Composition, functioning and funding of Advisory Councils 1. Advisory Councils shall be composed of: (a) organisations representing the fisheries and, where appropriate, aquaculture operators, and representatives of the processing and marketing sectors; (b) other interest groups affected by the CFP (e.g. environmental organisations and consumer groups). 2. Each Advisory Council shall consist of a general assembly and an executive committee, including, as appropriate, a secretariat and working groups to deal with issues of regional cooperation pursuant to Article 18, and shall adopt the measures necessary for its functioning. 3. Advisory Councils shall function and receive financing as provided for in Annex III. 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 46, laying down detailed rules on the functioning of Advisory Councils. PART XII PROCEDURAL PROVISIONS Article 46 Exercise of delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 11(2), Article 15(2), (3), (6), (7) and Article 45(4) shall be conferred on the Commission for a period of five years from 29 December 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 11(2), Article 15(2), (3), (6), (7) and Article 45(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 11(2), Article 15(2), (3), (6), (7) and Article 45(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 47 Committee procedure 1. The Commission shall be assisted by a Committee for fisheries and aquaculture. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion on a draft implementing act to be adopted pursuant to Article 23, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. PART XIII FINAL PROVISIONS Article 48 Repeals and amendments 1. Regulation (EC) No 2371/2002 is repealed. References to the repealed Regulation shall be construed as references to this Regulation. 2. Decision 2004/585/EC is repealed with effect from the entry into force of the rules adopted under Article 45(4) of this Regulation. 3. Article 5 of Council Regulation (EC) No 1954/2003 (25) shall be deleted. 4. Council Regulation (EC) No 639/2004 (26) is repealed. 5. In Article 105 of Regulation (EC) No 1224/2009, the following paragraph is inserted: \"3a. By way of derogation from paragraphs 2 and 3, no multiplying factor shall be applied to catches which are subject to an obligation to land in accordance with Article 15 of the Regulation (EU) No 1380/2013 of the European Parliament and of the Council (27), provided that the extent of overfishing relative to the permitted landings does not exceed 10 %. Article 49 Review The Commission shall report to the European Parliament and to the Council on the functioning of the CFP by 31 December 2022. Article 50 Annual report The Commission shall report annually to the European Parliament and to the Council on the progress on achieving maximum sustainable yield and on the situation of fish stocks, as early as possible following the adoption of the yearly Council Regulation fixing the fishing opportunities available in Union waters and, in certain non-Union waters, to Union vessels. Article 51 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 December 2013. For the European Parliament The President M. SCHULZ For the Council The President V. LE\u0160KEVI\u010cIUS (1) OJ C 181, 21.6.2012, p. 183. (2) OJ C 225, 27.7.2012, p. 20. (3) Position of the European Parliament of 6 February 2013 (not yet published in the Official Journal) and position of the Council at first reading of 17 October 2013 (not yet published in the Official Journal). Position of the European Parliament of 9 December 2013 (not yet published in the Official Journal). (4) Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (OJ L 358, 31.12.2002, p. 59). (5) The United Nations Convention on the Law of the Sea and of the Agreement on the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 3). (6) Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 1). (7) Council Decision 98/414/EC of 8 June 1998 on the ratification by the European Community of the Agreement for the implementing of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling stocks and highly migratory fish stocks (OJ L 189, 3.7.1998, p. 14). (8) Agreement on the implementation of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks (OJ L 189, 3.7.1998, p. 16). (9) Council Decision 96/428/EC of 25 June 1996 on acceptance by the Community of the Agreement to promote compliance with international conservation and management measures by fishing vessels on the high seas (OJ L 177, 16.7.1996, p. 24). (10) Agreement to promote compliance with international conservation and management measures by fishing vessels on the high seas (OJ L 177, 16.7.1996, p. 26). (11) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (12) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). (13) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). (14) Council resolution of 3 November 1976 on certain external aspects of the creation of a 200-mile fishing zone in the Community with effect from 1 January 1977 (OJ C 105, 7.5.1981, p. 1). (15) Commission Decision 2005/629/EC of 26 August 2005 establishing a Scientific, Technical and Economic Committee for Fisheries (OJ L 225, 31.8.2005, p. 18). (16) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (17) Council Decision 2004/585/EC of 19 July 2004 establishing Regional Advisory Councils under the Common Fisheries Policy (OJ L 256, 3.8.2004, p. 17). (18) Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, p. 11). (19) Council Regulation (EEC) No 2930/86 of 22 September 1986 defining characteristics for fishing vessels (OJ L 274, 25.9.1986, p. 1). (20) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (21) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (22) ICES (International Council for the Exploration of the Sea) zones are as defined in Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (OJ L 87, 31.3.2009, p. 70). (23) CECAF (Eastern Central Atlantic or FAO major fishing zone 34) zones are as defined in Regulation (EC) No 216/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in certain areas other than those of the North Atlantic (OJ L 87, 31.3.2009, p. 1). (24) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (See page 1 of this Official Journal). (25) Council Regulation (EC) No 1954/2003 of 4 November 2003 on the management of the fishing effort relating to certain Community fishing areas and resources and modifying Regulation (EC) No 2847/93 and repealing Regulations (EC) No 685/95 and (EC) No 2027/95 (OJ L 289, 7.11.2003, p. 1). (26) Council Regulation (EC) No 639/2004 of 30 March 2004 on the management of fishing fleets registered in the Community outermost regions (OJ L 102, 7.4.2004, p. 9). (27) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 23)\". ANNEX I ACCESS TO COASTAL WATERS WITHIN THE MEANING OF ARTICLE 5(2) 1. Coastal waters of the united kingdom A. ACCESS FOR FRANCE Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. Berwick-upon-Tweed east Coquet Island east Herring Unlimited 2. Flamborough Head east Spurn Head east Herring Unlimited 3. Lowestoft east Lyme Regis south All species Unlimited 4. Lyme Regis south Eddystone south Demersal Unlimited 5. Eddystone south Longships south-west Demersal Unlimited Scallops Unlimited Lobster Unlimited Crawfish Unlimited 6. Longships south-west Hartland Point north-west Demersal Unlimited Crawfish Unlimited Lobster Unlimited 7. Hartland Point to a line from the north of Lundy Island Demersal Unlimited 8. From a line due west Lundy Island to Cardigan Harbour All species Unlimited 9. Point Lynas North Morecambe Light Vessel east All species Unlimited 10. County Down Demersal Unlimited 11. New Island north-east Sanda Island south-west All species Unlimited 12. Port Stewart north Barra Head west All species Unlimited 13. Latitude 57\u00b040'N Butt of Lewis west All species, except shellfish Unlimited 14. St Kilda, Flannan Islands All species Unlimited 15. West of the line joining Butt of Lewis lighthouse to the point 59\u00b030'N-5\u00b045'W All species Unlimited B. ACCESS FOR IRELAND Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. Point Lynas north Mull of Galloway south Demersal Unlimited Nephrops Unlimited 2. Mull of Oa west Barra Head west Demersal Unlimited Nephrops Unlimited C. ACCESS FOR GERMANY Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. East of Shetlands and Fair Isle between lines drawn due south-east from Sumbrugh Head lighthouse due north-east from Skroo lighthouse and due south-west from Skadan lighthouse Herring Unlimited 2. Berwick-upon-Tweed east, Whitby High lighthouse east Herring Unlimited 3. North Foreland lighthouse east, Dungeness new lighthouse south Herring Unlimited 4. Zone around St Kilda Herring Unlimited Mackerel Unlimited 5. Butt of Lewis lighthouse west to the line joining Butt of Lewis lighthouse and the point 59\u00b030'N-5\u00b045'W Herring Unlimited 6. Zone around North Rona and Sulisker (Sulasgeir) Herring Unlimited D. ACCESS FOR THE NETHERLANDS Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. East of Shetlands and Fair Isle between lines drawn due south-east from Sumburgh Head lighthouse due north-east from Skroo lighthouse and due south-west from Skadan lighthouse Herring Unlimited 2. Berwick upon Tweed east, Flamborough Head east Herring Unlimited 3. North Foreland east, Dungeness new lighthouse south Herring Unlimited E. ACCESS FOR BELGIUM Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. Berwick upon Tweed east Coquet Island east Herring Unlimited 2. Cromer north North Foreland east Demersal Unlimited 3. North Foreland east Dungeness new lighthouse south Demersal Unlimited Herring Unlimited 4. Dungeness new lighthouse south, Selsey Bill south Demersal Unlimited 5. Straight Point south-east, South Bishop north-west Demersal Unlimited 2. Coastal waters of ireland A. ACCESS FOR FRANCE Geographical area Species Importance or particular characteristics Irish coast (6 to 12 nautical miles) 1. Erris Head north-west Sybil Point west Demersal Unlimited Nephrops Unlimited 2. Mizen Head south Stags south Demersal Unlimited Nephrops Unlimited Mackerel Unlimited 3. Stags south Cork south Demersal Unlimited Nephrops Unlimited Mackerel Unlimited Herring Unlimited 4. Cork south, Carnsore Point south All species Unlimited 5. Carnsore Point south, Haulbowline south-east All species, except shellfish Unlimited B. ACCESS FOR THE UNITED KINGDOM Geographical area Species Importance or particular characteristics Irish coast (6 to 12 miles) 1. Mine Head south Hook Point Demersal Unlimited Herring Unlimited Mackerel Unlimited 2. Hook Point Carlingford Lough Demersal Unlimited Herring Unlimited Mackerel Unlimited Nephrops Unlimited Scallops Unlimited C. ACCESS FOR THE NETHERLANDS Geographical area Species Importance or particular characteristics Irish coast (6 to 12 miles) 1. Stags south Carnsore Point south Herring Unlimited Mackerel Unlimited D. ACCESS FOR GERMANY Geographical area Species Importance or particular characteristics Irish coast (6 to 12 nautical miles) 1. Old Head of Kinsale south Carnsore Point south Herring Unlimited 2. Cork south Carnsore Point south Mackerel Unlimited E. ACCESS FOR BELGIUM Geographical area Species Importance or particular characteristics Irish coast (6 to 12 nautical miles) 1. Cork south Carnsore Point south Demersal Unlimited 2. Wicklow Head east Carlingford Lough south-east Demersal Unlimited 3. Coastal waters of belgium Geographical area Member State Species Importance or particular characteristics 3 to 12 nautical miles Netherlands All species Unlimited France Herring Unlimited 4. Coastal waters of denmark Geographical area Member State Species Importance or particular characteristics North Sea coast (Danish/German frontier to Hanstholm) (6 to 12 nautical miles) Danish/German frontier to Bl\u00e5vands Huk Germany Flatfish Unlimited Shrimps and prawns Unlimited Netherlands Flatfish Unlimited Roundfish Unlimited Bl\u00e5vands Huk to Bovbjerg Belgium Cod Unlimited only from 1 June to 31 July Haddock Unlimited only from 1 June to 31 July Germany Flatfish Unlimited Netherlands Plaice Unlimited Sole Unlimited Thybor\u00f8n to Hanstholm Belgium Whiting Unlimited only from 1 June to 31 July Plaice Unlimited only from 1 June to 31 July Germany Flatfish Unlimited Sprat Unlimited Cod Unlimited Saithe Unlimited Haddock Unlimited Mackerel Unlimited Herring Unlimited Whiting Unlimited Netherlands Cod Unlimited Plaice Unlimited Sole Unlimited Skagerrak (Hanstholm to Skagen) (4 to 12 nautical miles) Belgium Plaice Unlimited only from 1 June to 31 July Germany Flatfish Unlimited Sprat Unlimited Cod Unlimited Saithe Unlimited Haddock Unlimited Mackerel Unlimited Herring Unlimited Whiting Unlimited Netherlands Cod Unlimited Plaice Unlimited Sole Unlimited Kattegat (3 to 12 miles) Germany Cod Unlimited Flatfish Unlimited Nephrops Unlimited Herring Unlimited North of Zeeland to the parallel of the latitude passing through Forsn\u00e6s lighthouse Germany Sprat Unlimited Baltic Sea (including Belts, Sound, Bornholm) (3 to 12 nautical miles) Germany Flatfish Unlimited Cod Unlimited Herring Unlimited Sprat Unlimited Eel Unlimited Salmon Unlimited Whiting Unlimited Mackerel Unlimited Skagerrak (4 to 12 miles) Sweden All species Unlimited Kattegat (3 to 12 miles (1)) Sweden All species Unlimited Baltic Sea (3 to 12 miles) Sweden All species Unlimited 5. Coastal waters of germany Geographical area Member State Species Importance or particular characteristics North Sea coast (3 to 12 nautical miles) all coasts Denmark Demersal Unlimited Sprat Unlimited Sandeel Unlimited Netherlands Demersal Unlimited Shrimps and prawns Unlimited Danish/German frontier to the northern tip of Amrum at 54\u00b043\u2032N Denmark Shrimps and prawns Unlimited Zone around Helgoland United Kingdom Cod Unlimited Plaice Unlimited Baltic coast (3 to 12 miles) Denmark Cod Unlimited Plaice Unlimited Herring Unlimited Sprat Unlimited Eel Unlimited Whiting Unlimited Mackerel Unlimited 6. Coastal waters of france and the overseas departments Geographical area Member State Species Importance or particular characteristics North-east Atlantic coast (6 to 12 nautical miles) Belgian/French frontier to east of Departement Manche (Vire-Grandcamp les Bains estuary 49\u00b0 23' 30\" N-1\u00b0 2 'WNNE) Belgium Demersal Unlimited Scallops Unlimited Netherlands All Species Unlimited Dunkerque (2\u00b0 20' E) to Cap d'Antifer (0\u00b0 10' E) Germany Herring Unlimited only from 1 October to 31 December Belgian/French frontier to Cap d'Alprech west (50\u00b0 42 30\" N \u2014 1\u00b0 33' 30\" E) United Kingdom Herring Unlimited Atlantic Coast (6 to 12 nautical miles) Spanish/French frontier to 46\u00b0 08\u2032 N Spain Anchovies Directed fishing, unlimited only from 1 March to 30 June Fishing for live bait from 1 July to 31 October only Sardines Unlimited only from 1 January to 28 February and from 1 July to 31 December In addition, activities relating to the abovementioned species must be pursued in accordance with, and within the limits of, the activities pursued during 1984 Mediterranean coast (6 to 12 nautical miles) Spanish frontier Cap Leucate Spain All species Unlimited 7. Coastal waters of spain Geographical area Member State Species Importance or particular characteristics Atlantic coast (6 to 12 nautical miles) French/Spanish frontier to Cap Mayor lighthouse (3\u00b0 47' W) France Pelagic Unlimited in accordance with, and within the limits of, the activities pursued during 1984 Mediterranean coast (6 to 12 nautical miles) French frontier/Cap Creus France All species Unlimited 8. Coastal waters of croatia (2) Geographical area Member State Species Importance or particular characteristics 12 miles limited to the sea area under the sovereignty of Croatia situated to the north of the 45 degrees and 10 minutes parallel north latitude along the west Istrian coast, from the outer limit of the territorial sea of Croatia, where this parallel touches the land of the west Istrian coast (the cape Grgatov rt Funtana) Slovenia Demersal and small pelagic species including sardine and anchovy 100 tonnes for a maximum number of 25 fishing vessels which includes 5 fishing vessels equipped with trawl nets 9. Coastal waters of the netherlands Geographical area Member State Species Importance or particular characteristics (3 to 12 nautical miles) whole coast Belgium All species Unlimited Denmark Demersal Unlimited Sprat Unlimited Sandeel Unlimited Horse-mackerel Unlimited Germany Cod Unlimited Shrimps and prawns Unlimited (6 to 12 nautical miles) whole coast France All species Unlimited Texel south point, west to the Netherlands/German frontier United Kingdom Demersal Unlimited 10. Coastal waters of slovenia (3) Geographical area Member State Species Importance or particular characteristics 12 miles limited to the sea area under the sovereignty of Slovenia situated to the north of the 45 degrees and 10 minutes parallel north latitude along the west Istrian coast, from the outer limit of the territorial sea of Croatia, where this parallel touches the land of the west Istrian coast (the cape Grgatov rt Funtana) Croatia Demersal and small pelagic species including sardine and anchovy 100 tonnes for a maximum number of 25 fishing vessels which includes 5 fishing vessels equipped with trawl nets 11. Coastal waters of finland Geographical area Member State Species Importance or particular characteristics Baltic Sea (4 to 12 miles) (4) Sweden All species Unlimited 12. Coastal waters of sweden Geographical area Member State Species Importance or particular characteristics Skagerrak (4 to 12 nautical miles) Denmark All species Unlimited Kattegat (3 to 12 miles (5)) Denmark All species Unlimited Baltic Sea (4 to 12 miles) Denmark All species Unlimited Finland All species Unlimited (1) Measured from the coastline. (2) The above mentioned regime shall apply from the full implementation of the arbitration award resulting from the Arbitration Agreement between the Government of the Republic of Slovenia and the Government of the Republic of Croatia, signed in Stockholm on 4 November 2009. (3) The above mentioned regime shall apply from the full implementation of the arbitration award resulting from the Arbitration Agreement between the Government of the Republic of Slovenia and the Government of the Republic of Croatia, signed in Stockholm on 4 November 2009. (4) 3 to 12 miles around Bogsk\u00e4r Isles. (5) Measured from the coastline. ANNEX II FISHING CAPACITY CEILINGS Capacity ceilings Member State GT kW Belgium 18 962 51 586 Bulgaria 7 250 62 708 Denmark 88 762 313 333 Germany 71 117 167 078 Estonia 21 677 52 566 Ireland 77 568 210 083 Greece 84 123 469 061 Spain (including outermost regions) 423 550 964 826 France (including outermost regions) 214 282 1 166 328 Croatia 53 452 426 064 Italy 173 506 1 070 028 Cyprus 11 021 47 803 Latvia 46 418 58 496 Lithuania 73 489 73 516 Malta 14 965 95 776 Netherlands 166 859 350 736 Poland 38 270 90 650 Portugal (including outermost regions) 114 549 386 539 Romania 1 908 6 356 Slovenia 675 8 867 Finland 18 066 181 717 Sweden 43 386 210 829 United Kingdom 231 106 909 141 Capacity ceilings Outermost regions of the Union GT kW Spain Canary Islands: L (1) < 12 m. Union waters 2 617 20 863 Canary Islands: L > 12 m. Union waters 3 059 10 364 Canary Islands: L > 12 m. International and third country waters 28 823 45 593 France Reunion Island: Demersal and pelagic species. L < 12 m 1 050 19 320 Reunion Island: Pelagic species. L > 12 m 10 002 31 465 French Guyana: Demersal and pelagic species. Length < 12 m 903 11 644 French Guyana: Shrimp vessels 7 560 19 726 French Guyana: Pelagic species. Offshore vessels. 3 500 5 000 Martinique: Demersal and pelagic species. L < 12 m 5 409 142 116 Martinique: Pelagic species. L > 12 m 1 046 3 294 Guadeloupe: Demersal and pelagic species. L < 12 m 6 188 162 590 Guadeloupe: Pelagic species. L > 12 m 500 1 750 Portugal Madeira: Demersal species. L < 12 m 604 3 969 Madeira: Demersal and pelagic species. L > 12 m 4 114 12 734 Madeira: Pelagic species. Seine. L > 12 m 181 777 Azores: Demersal species. L < 12 m 2 617 29 870 Azores: Demersal and pelagic species. L > 12 m 12 979 25 721 (1) \"L\" means overall length of a vessel. ANNEX III ADVISORY COUNCILS 1. Name and area of competence of Advisory Councils Name Areas of competence Baltic Sea ICES zones IIIb, IIIc and IIId Black Sea GFCM geographical sub-area as defined in Resolution GFCM/33/2009/2 Mediterranean Sea Maritime Waters of the Mediterranean of the East of line 5\u00b036\u2032 West North Sea ICES zones IV and IIIa North Western waters ICES zones V (excluding Va and only Union waters of Vb), VI and VII South Western waters ICES zones VIII, IX and X (waters around Azores), and CECAF zones 34.1.1, 34.1.2 and 34.2.0 (waters around Madeira and the Canary Islands) Outermost regions Union waters around the outermost regions as referred to in the first paragraph of Article 349 of the Treaty divided into three sea basins: West Atlantic, East Atlantic, Indian Ocean Pelagic stocks (blue whiting, mackerel, horse mackerel, herring, boarfish) All geographical areas excluding the Baltic Sea and the Mediterranean Sea High seas/long distance fleet All non Union-waters Aquaculture Aquaculture, as defined in Article 4 Markets All market areas 2. Functioning and funding of Advisory Councils (a) In the general assembly and executive committee, 60 % of the seats shall be allotted to representatives of fishermen and for the Aquaculture Advisory Council, aquaculture operators, and representatives of the processing and marketing sectors, and 40 % to representatives of the other interest groups affected by the Common Fisheries Policy, for example environmental organisations and consumer groups. (b) Except for the Advisory Council for Aquaculture and for the Advisory Council for Markets, at least one representative of the catching subsector from each Member State concerned shall be member of the executive committee. (c) The members of the executive committee shall, where possible, adopt recommendations by consensus. If no consensus can be reached, dissenting opinions expressed by members shall be recorded in the recommendations adopted by the majority of the members present and voting. (d) Each Advisory Council shall designate a chairperson by consensus. The chairperson shall act impartially. (e) Each Advisory Council shall adopt the measures necessary to ensure transparency and the respect of all opinions expressed. (f) Recommendations adopted by the executive committee shall be made available immediately to the general assembly, the Commission, Member States concerned and, upon request, to any member of the public. (g) The meetings of the general assembly shall be open to the public. The meetings of the executive committee shall be open to the public unless, in exceptional cases, decided otherwise by a majority of the executive committee. (h) European and national organisations representing the fisheries sector and other interest groups may propose members to the Member States concerned. Those Member States shall agree on the members of the general assembly. (i) Representatives of national and regional administrations that have fisheries interests in the area concerned and researchers from the Member States' scientific and fisheries research institutes and from the international scientific institutions that advise the Commission shall be allowed to participate in Advisory Council meetings as active observers. Any other qualified scientist may also be invited. (j) Representatives of the European Parliament and of the Commission may take part as active observers in Advisory Council meetings. (k) When issues that affect them are discussed, representatives of the fisheries sector and other interest groups from third countries, including representatives from RFMOs, that have a fishing interest in the area or fisheries covered by an Advisory Council, may be invited to participate as active observers. (l) Advisory Councils may apply for Union financial assistance as bodies pursuing an aim of general European interest. (m) The Commission shall sign a grant agreement with each Advisory Council to contribute to its operational costs, including translation and interpretation costs. (n) The Commission may carry out all verifications it considers necessary to ensure compliance with the tasks assigned to the Advisory Councils. (o) Each Advisory Council shall transmit annually its budget and a report of its activities to the Commission and to the Member States concerned. (p) The Commission or the Court of Auditors may at any time arrange for an audit to be carried out either by an outside body of its choice or by the Commission or the Court of Auditors departments themselves. (q) Each Advisory Council shall appoint a certified auditor for the period during which it benefits from Union funds.", "summary": "The EU\u2019s common fisheries policy The EU\u2019s common fisheries policy SUMMARY OF: Regulation (EU) No 1380/2013 on the common fisheries policy WHAT IS THE AIM OF THE REGULATION? The regulation includes the basic rules of the common fisheries policy (CFP) in the European Union (EU). The CFP aims to ensure that fishing and aquaculture activities contribute to long-term environmental, economic and social sustainability. In line with the European Green Deal (see summary) and the biodiversity strategy 2030 (see summary), EU fisheries are governed by the precautionary principle in order to limit the impact of fishing activities on the marine ecosystem. The CFP builds on four pillars: fisheries management;international policy;market and trade policy; andfinancial support, i.e. the European Maritime, Fisheries and Aquaculture Fund (see summary). The CFP establishes rules for the management of fisheries, thus contributing to the conservation of marine biological resources, increased productivity, a fair standard of living for the fisheries sector, stable markets and the availability of food supplies at reasonable prices. Regarding market measures and financial support, the CFP also covers freshwater biological resources and aquaculture activities, along with the processing and marketing of fishery and aquaculture products. KEY POINTS Fisheries management aims to enable fishers to maximise their catches without threatening the reproduction of fish stocks (their \u2018maximum sustainable yield\u2019*. To this end, total allowable catches (or \u2018fishing opportunities\u2019) are set for most commercial fish stocks. Fishing levels had to conform to maximum sustainable yield levels for all stocks by 2015, if possible, and no later than 2020. The management of fish stocks is based on scientific advice. EU Member States must collect, manage and make available the data needed for scientific advice. This includes biological, environmental and socioeconomic data. Data collection activities are financially supported by the EU. By introducing a landing obligation*, the CFP aims to end the wasteful practice of returning unwanted catches to the sea (discarding). The landing obligation was gradually phased in over the 2015\u20132019 period and is now fully in force, requiring fishers to land all catches of regulated commercial species. Multiannual plans set targets for the management of fish stocks. Where the adoption of multiannual plans or management plans that include discard plans takes longer than envisaged, Regulation (EU) 2017/2092 (amending Regulation (EU) No 1380/2013) empowers the European Commission to adopt discard plans. Technical measures are a broad set of rules that govern how, where and when fishers may fish. They are established for all European sea basins, but they differ considerably from one sea basin to another, reflecting regional circumstances. The CFP decentralises decision-making by bringing it closer to the fishing grounds (a process known as regionalisation). It provides for the establishment of advisory councils for each of the geographical areas. Member States with a management interest in a given area can propose detailed measures, which the Commission can adopt into EU law. A fisheries control system ensures compliance with the CFP rules, including the fight against illegal, unreported and unregulated fishing (Regulation (EC) No 1005/2008 \u2013 see summary). Regulation (EU) No 1026/2012 (see summary) lays down the rules that apply to conserving fish stocks in countries with unsustainable fishing. New marketing standards with respect to labelling, quality and traceability allow consumers to be better informed about the origin of the fish they buy and its mode of production. The sustainability principle also applies to EU vessels fishing outside EU waters. The Commission is granted the power to negotiate and conclude sustainable fisheries partnership agreements on behalf of the EU with certain non-EU partner countries. These agreements: allow EU vessels to fish for surplus stocks in the partner country\u2019s exclusive economic zone* in a legally regulated environment in return for a financial contribution;focus on resource conservation and environmental sustainability, ensuring that all EU vessels are subject to the same rules of control and transparency. Member States must support the development of sustainable aquaculture through multiannual national plans. Review of the reformed CFP Every year, the Commission publishes a communication outlining progress on the situation of fish stocks and launching a wide public consultation on the fixing of annual fishing opportunities for the following year. This communication assesses the progress made towards sustainable fishing in the EU and reviews the balance between fishing capacity and fishing opportunities, the sector\u2019s socio-economic performance and the implementation of the landing obligation. It also sets out the rationale for the proposal on fishing opportunities for the following year. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND The CFP was first launched in 1970. It has undergone several reforms, the most recent of which took effect on 1 January 2014. For further information, see: Common fisheries policy (CFP) (European Commission). KEY TERMS Maximum sustainable yield. The highest theoretical equilibrium yield that can be continuously taken on average from a stock under existing average environmental conditions without significantly affecting the reproduction process. Landing obligation. The requirement for EU vessels to land all catches to end the wasteful practice of returning unwanted catches to the sea. Exclusive economic zone. An area of coastal water and seabed within a certain distance of a country\u2019s coastline, to which the country claims exclusive rights for fishing, drilling and other economic activities. MAIN DOCUMENT Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the common fisheries policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, pp. 22\u201361). Successive amendments to Regulation (EU) No 1380/2013 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2021/1139 of the European Parliament and of the Council of 7 July 2021 establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 (OJ L 247, 13.7.2021, pp. 1\u201349). Communication from the Commission to the European Parliament and the Council \u2013 Towards more sustainable fishing in the EU: state of play and orientations for 2022 (COM(2021) 279 final, 9.6.2021). Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions \u2013 The European Green Deal (COM(2019) 640 final, 11.12.2019). Regulation (EU) 2019/1241 of the European Parliament and of the Council of 20 June 2019 on the conservation of fisheries resources and the protection of marine ecosystems through technical measures, amending Council Regulations (EC) No 1967/2006, (EC) No 1224/2009 and Regulations (EU) No 1380/2013, (EU) 2016/1139, (EU) 2018/973, (EU) 2019/472 and (EU) 2019/1022 of the European Parliament and of the Council, and repealing Council Regulations (EC) No 894/97, (EC) No 850/98, (EC) No 2549/2000, (EC) No 254/2002, (EC) No 812/2004 and (EC) No 2187/2005 (OJ L 198, 25.7.2019, pp. 105\u2013201). See consolidated version. Regulation (EU) 2017/1004 of the European Parliament and of the Council of 17 May 2017 on the establishment of a Union framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the common fisheries policy and repealing Council Regulation (EC) No 199/2008 (OJ L 157, 20.6.2017, pp. 1\u201321). See consolidated version. Regulation (EU) 2016/1627 of the European Parliament and of the Council of 14 September 2016 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, and repealing Council Regulation (EC) No 302/2009 (OJ L 252, 16.9.2016, pp. 1\u201352). See consolidated version. Regulation (EU) No 1026/2012 of the European Parliament and of the Council of 25 October 2012 on certain measures for the purpose of the conservation of fish stocks in relation to countries allowing non-sustainable fishing (OJ L 316, 14.11.2012, pp. 34\u201337). Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1\u201350). See consolidated version. Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, pp. 1\u201332). See consolidated version. last update 21.03.2022"}
{"article": "28.12.2013 EN Official Journal of the European Union L 354/1 REGULATION (EU) No 1379/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 42 and 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The scope of the Common Fisheries Policy (CFP) extends to measures related to the markets for fishery and aquaculture products in the Union. The common organisation of the markets in fishery and aquaculture products (CMO) is an integral part of the CFP and should contribute to achieving its objectives. Since the CFP is being revised, the CMO should be adapted accordingly. (2) Council Regulation (EC) No 104/2000 (4) needs to be revised in order to take account of shortcomings detected in the implementation of the provisions currently in force, recent developments in Union and world markets, and the evolution of fishing and aquaculture activities. (3) Fishing plays a particularly important role in the economies of the Union's coastal regions, including the outermost regions. Given that it provides fishermen in those regions with their livelihood, steps should be taken to foster market stability and a closer correlation between supply and demand. (4) The provisions of the CMO should be implemented in compliance with the international commitments of the Union, in particular with regard to those under the provisions of the World Trade Organisation. When trading in fishery and aquaculture products with third countries, the conditions for fair competition should be ensured, in particular through respect for sustainability and the application of social standards equivalent to those which apply to Union products. (5) It is important that the management of the CMO be guided by the principles of good governance of the CFP. (6) In order for the CMO to be a success, it is essential that consumers are informed, through marketing and educational campaigns, of the value of eating fish and the wide variety of species available, as well as of the importance of understanding the information contained on labels. (7) Fishery producer organisations and aquaculture producer organisations (\"producer organisations\") are the key to achieving the objectives of the CFP and of the CMO. It is therefore necessary to enhance their responsibilities and to provide the necessary financial support to allow them to play a more meaningful role in the day-to-day management of fisheries, whilst respecting the framework defined by objectives of the CFP. It is also necessary to ensure that their members carry out fishing and aquaculture activities in a sustainable manner, improve the placing on the market of products, collect information on aquaculture and improve their incomes. When achieving those objectives, producer organisations should take into account the different conditions of the fishery and aquaculture sectors that prevail in the Union, including in the outermost regions, and in particular the special characteristics of small-scale fisheries and extensive aquaculture. It should be possible for competent national authorities to take responsibility for the implementation of those objectives, working closely with producer organisations on management issues, including, where appropriate, the allocation of quotas and the management of fishing effort, depending on the needs of each particular fishery. (8) Measures should be taken to encourage the appropriate and representative participation of small-scale producers. (9) In order to strengthen the competitiveness and viability of producer organisations, appropriate criteria for their establishment should be clearly defined. (10) Inter-branch organisations consisting of different categories of operators in the fishery and aquaculture sector have the potential to help improve the coordination of marketing activities along the supply chain and to develop measures of interest for the whole sector. (11) It is appropriate to lay down common conditions for the recognition of producer organisations and inter-branch organisations by Member States, for the extension of the rules adopted by producer organisations and inter-branch organisations, and for the costs resulting from such extension to be shared. The extension of the rules should be subject to authorisation by the Commission. (12) As fish stocks are shared resources, their sustainable and efficient exploitation can, in certain instances, be better achieved by organisations composed of members from different Member States and different regions. Therefore, it is also necessary to encourage the possibility of setting up producer organisations and associations of producer organisations at national or transnational level based, where appropriate, on biogeographical regions. Such organisations should be partnerships that seek to lay down common and binding rules and to provide a level-playing field for all stakeholders that are engaged in the fishery. In setting up such organisations, it is necessary to ensure that they remain subject to the competition rules provided for in this Regulation and that the need to maintain the link between individual coastal communities and the fisheries and waters that they have historically exploited is respected. (13) The Commission should encourage supportive measures to foster the participation of women in aquaculture producer organisations. (14) In order to be able to steer their members towards sustainable fishery and aquaculture activities, producer organisations should prepare and submit to the competent authorities of their Member States a production and marketing plan containing the measures necessary for them to fulfil their objectives. (15) In order to achieve the objectives of the CFP as regards discards, widespread use needs to be made of selective fishing gear that will prevent under-sized fish from being caught. (16) The unpredictability of fishing activities makes it appropriate to set up a mechanism for storing fishery products for human consumption with a view to fostering greater market stability and increasing the return on products, in particular by creating added value. That mechanism should contribute to the stabilisation and convergence of local markets in the Union with a view to achieving the objectives of the internal market. (17) In order to take account of the diversity of prices throughout the Union, each fishery producer organisation should be entitled to make a proposal for a price to trigger the storage mechanism. That trigger price should be set in such a way that fair competition between operators is maintained. (18) The establishment and application of common marketing standards should enable the market to be supplied with sustainable products and the full potential of the internal market in fishery and aquaculture products to be realised, and should facilitate marketing activities based on fair competition, thereby helping to improve the profitability of production. To that end, the existing marketing standards should continue to apply. (19) It is necessary to ensure that imported products entering the Union market comply with the same requirements and marketing standards that Union producers have to comply with. (20) In order to guarantee a high level of protection of human health, fishery and aquaculture products placed on the Union market, regardless of their origin, should comply with applicable rules on food safety and hygiene. (21) In order to enable consumers to make informed choices, it is necessary for them to be provided with clear and comprehensive information on, inter alia, the origin and the method of production of the products. (22) The use of an eco-label for fishery and aquaculture products, whether or not they originate from inside or outside the Union, offers the possibility of providing clear information on the ecological sustainability of such products. It is therefore necessary for the Commission to examine the possibility of developing and establishing minimum criteria for the development of a Union-wide eco-label for fishery and aquaculture products. (23) For the purpose of consumer protection, competent national authorities responsible for monitoring and enforcing the fulfilment of the obligations laid down in this Regulation should make full use of available technology, including DNA-testing, in order to deter operators from falsely labelling catches. (24) The rules on competition relating to agreements, decisions and practices referred to in Article 101 of the Treaty on the Functioning of the European Union (TFEU) should apply to the production or marketing of fishery and aquaculture products, in so far as their application does not impede the functioning of the CMO or jeopardise the achievement of the objectives laid down in Article 39 TFEU. (25) It is appropriate to lay down competition rules applicable to the production and marketing of fishery and aquaculture products, taking into account the specific characteristics of the fishery and aquaculture sector, including fragmentation of the sector, the fact that fish are a shared resource and the large extent of imports, which should be subject to the same rules as Union fishery and aquaculture products. In the interests of simplification, the relevant provisions of Council Regulation (EC) No 1184/2006 (5) should be incorporated into this Regulation. Regulation (EC) No 1184/2006 should, therefore, no longer be applicable to fishery and aquaculture products. (26) It is necessary to improve the gathering, processing and disseminating of economic information on the markets in fishery and aquaculture products in the Union. (27) In order to ensure uniform conditions for the implementation of the provisions of this Regulation in respect of: the time\u2013limits, procedures and form of applications for the recognition of producer and inter-branch organisations and for the withdrawal of such recognition; the formats, time\u2013limits and procedures of the Member States for communicating decisions to grant or withdraw recognition; the format and the procedure of the notification by the Member States of rules binding on all producers or operators; the format and structure of the production and marketing plans, as well as the procedure and the time\u2013limits for submission and approval of them; the format of publication by the Member States of the trigger prices, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6). (28) Regulation (EC) No 104/2000 should be repealed. However, in order to ensure continuity in the provision of consumer information, Article 4 thereof should continue to apply until 12 December 2014. (29) Since the objective of this Regulation, namely the establishment of the common organisation of the markets in fishery and aquaculture products, cannot be sufficiently achieved by the Member States due to the common nature of the market in fishery and aquaculture products and can therefore, by reason of its scale and effects and the need for common action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve this objective. (30) Regulations (EC) No 1184/2006 and (EC) No 1224/2009 should therefore be amended accordingly, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter 1. A common organisation of the markets in fishery and aquaculture products (CMO) is hereby established. 2. The CMO shall be comprised of the following elements: (a) professional organisations; (b) marketing standards; (c) consumer information; (d) competition rules; (e) market intelligence. 3. The CMO shall be supplemented, as regards external aspects, by Council Regulation (EU) No 1220/2012 (7) and by Regulation (EU) No 1026/2012 of the European Parliament and of the Council (8). 4. Implementation of the CMO shall be eligible to receive Union financial support in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014\u20132020. Article 2 Scope The CMO shall apply to the fishery and aquaculture products listed in Annex I to this Regulation, which are marketed in the Union. Article 3 Objectives The objectives of the CMO are those laid down in Article 35 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (9). Article 4 Principles The CMO shall be guided by the principles of good governance laid down in Article 3 of Regulation (EU) No 1380/2013. Article 5 Definitions For the purposes of this Regulation, the definitions referred to in Article 4 of Regulation (EU) No 1380/2013, as well as those referred to in Article 4 of Council Regulation (EC) No 1224/2009 (10), in Article 2 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council (11), in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (12), and in Article 3 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council (13), shall apply. The following definitions shall also apply: (a) 'fishery products' mean aquatic organisms resulting from any fishing activity or products derived therefrom, as listed in Annex I; (b) 'aquaculture products' mean aquatic organisms at any stage of their life cycle resulting from any aquaculture activity or products derived therefrom, as listed in Annex I; (c) 'producer' means any natural or legal person using means of production to obtain fishery or aquaculture products with a view to placing them on the market; (d) 'fishery and aquaculture sector' means the sector of the economy which comprises all activities of production, processing and marketing of fishery or aquaculture products; (e) 'making available on the market' means any supply of a fishery or aquaculture product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (f) 'placing on the market' means the first making available of a fishery or aquaculture product on the Union market; (g) 'retail' means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, including distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets; (h) 'prepacked fishery and aquaculture products' mean fishery and aquaculture products which are 'prepacked food' as referred to in point (e) of Article 2(2) of Regulation (EC) No 1169/2011. CHAPTER II PROFESSIONAL ORGANISATIONS SECTION I Establishment, objectives and measures Article 6 Establishment of fishery producer organisations and aquaculture producer organisations 1. Fishery producer organisations and aquaculture producer organisations (\"producer organisations\") may be established on the initiative of producers of fishery or aquaculture products in one or more Member States and recognised in accordance with Section II. 2. Where relevant, the specific situation of small-scale producers shall be taken into account when establishing producer organisations. 3. A producer organisation that is representative of both fishery and aquaculture activities may be established as a joint fishery and aquaculture producer organisation. Article 7 Objectives of producer organisations 1. Fishery producer organisations shall pursue the following objectives: (a) promoting the viable and sustainable fishing activities of their members in full compliance with the conservation policy, as laid down, in particular, in Regulation (EU) No 1380/2013 and in environmental law, while respecting social policy and, where the Member State concerned so provides, participating in the management of marine biological resources; (b) avoiding and reducing as far as possible unwanted catches of commercial stocks and, where necessary, making the best use of such catches, without creating a market for those that are below the minimum conservation reference size, in accordance with Article 15 of Regulation (EU) No 1380/2013; (c) contributing to the traceability of fishery products and access to clear and comprehensive information for consumers; (d) contributing to the elimination of illegal, unreported and unregulated fishing. 2. Aquaculture producer organisations shall pursue the following objectives: (a) promoting the sustainable aquaculture activities of their members through providing opportunities for their development in full compliance with, in particular, Regulation (EU) No 1380/2013 and with environmental law, while respecting social policy; (b) ascertaining that the activities of their members are consistent with the national strategic plans referred to in Article 34 of Regulation (EU) No 1380/2013; (c) endeavouring to ensure that aquaculture feed products of fishery origin come from fisheries that are sustainably managed. 3. Producer organisations shall, in addition to the objectives laid down in paragraphs 1 and 2, pursue two or more of the following objectives: (a) improving the conditions for the placing on the market of their members' fishery and aquaculture products; (b) improving economic returns; (c) stabilising the markets; (d) contributing to food supply and promoting high food quality and safety standards, whilst contributing to employment in coastal and rural areas; (e) reducing the environmental impact of fishing, including through measures to improve the selectivity of fishing gears. 4. Producer organisations may pursue other complementary objectives. Article 8 Measures deployable by producer organisations 1. In order to achieve the objectives set out in Article 7, producer organisations may, inter alia, make use of the following measures: (a) adjusting production to market requirements; (b) channelling the supply and marketing of their members' products; (c) promoting the Union fishery and aquaculture products of their members in a non-discriminatory manner by using, for example, certification, and in particular designations of origin, quality seals, geographical designations, traditional specialities guaranteed, and sustainability merits; (d) controlling and taking measures to ensure that their members' activities comply with the rules established by the producer organisation concerned; (e) promoting vocational training and cooperation programmes to encourage young people to enter the sector; (f) reducing the environmental impact of fishing, including through measures to improve the selectivity of fishing gears; (g) promoting the use of information and communication technology to improve marketing and prices; (h) facilitating consumer access to information on fishery and aquaculture products. 2. Fishery producer organisations may also make use of the following measures: (a) collectively planning and managing the fishing activities of their members, subject to the organisation, by Member States, of the management of marine biological resources, including developing and implementing measures to improve the selectivity of fishing activities and advising competent authorities; (b) avoiding and minimising unwanted catches through involvement in the development and application of technical measures, and making the best use of unwanted catches of commercial stocks without creating a market for those catches that are below the minimum conservation reference size, in accordance with Article 15(11) of Regulation (EU) No 1380/2013 and Article 34(2) of this Regulation, as appropriate; (c) managing temporary storage for fishery products in accordance with Articles 30 and 31 of this Regulation. 3. Aquaculture producer organisations may also make use of the following measures: (a) promoting sustainable aquaculture activities, notably in terms of environmental protection, animal health and animal welfare; (b) collecting information on the marketed products, including economic information on first sales, and on production forecasts; (c) collecting environmental information; (d) planning the management of the aquaculture activities of their members; (e) supporting programmes for professionals to promote sustainable aquaculture products. Article 9 Establishment of associations of producer organisations 1. An association of producer organisations may be established at the initiative of producer organisations recognised in one or more Member States. 2. The provisions of this Regulation applicable to producer organisations shall also apply to associations of producer organisations unless stated otherwise. Article 10 Objectives of associations of producer organisations 1. Associations of producer organisations shall pursue the following objectives: (a) performing in a more efficient and sustainable manner any of the objectives of the member producer organisations laid down in Article 7; (b) coordinating and developing activities of common interest for the member producer organisations. 2. Associations of producer organisations shall be eligible for financial support in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014\u20132020. Article 11 Establishment of inter-branch organisations Inter-branch organisations may be established at the initiative of operators of fishery and aquaculture products in one or more Member States and recognised in accordance with Section II. Article 12 Objectives of inter-branch organisations Inter-branch organisations shall improve the coordination of, and the conditions for, making fishery and aquaculture products available on the Union market. Article 13 Measures deployable by inter-branch organisations In order to achieve the objectives referred to in Article 12, inter-branch organisations may make use of the following measures: (a) drawing up standard contracts which are compatible with Union legislation; (b) promoting Union fishery and aquaculture products in a non-discriminatory manner by using, for example, certification, and in particular designations of origin, quality seals, geographical designations, traditional specialities guaranteed, and sustainability merits; (c) laying down rules on the production and marketing of fishery and aquaculture products which are stricter than those laid down in Union or national legislation; (d) improving quality, knowledge of, and the transparency of, production and the market, as well as carrying out professional and vocational training activities, for example, on quality and traceability matters, on food safety and in order to encourage research initiatives; (e) performing research and market studies, and developing techniques to optimise the operation of the market, including through the use of information and communication technology, as well as collecting socio-economic data; (f) providing the information and carrying out the research needed to deliver sustainable supplies at the quantity, quality and price corresponding to market requirements and consumer expectations; (g) promoting, among consumers, species obtained from fish stocks that are in a sustainable state, that have appreciable nutritional value and that are not widely consumed; (h) controlling and taking measures for compliance of their members' activities with the rules established by the inter-branch organisation concerned. SECTION II Recognition Article 14 Recognition of producer organisations 1. Member States may recognise as producer organisations all groups set up on the initiative of fishery or aquaculture producers which apply for such recognition, provided that they: (a) comply with the principles set out in Article 17 and with the rules adopted for their application; (b) are sufficiently economically active in the territory of the Member State concerned or a part thereof, in particular as regards the number of members or the volume of marketable production; (c) have legal personality under the national law of the Member State concerned, are established there and have their official headquarters in its territory; (d) are capable of pursuing the objectives laid down in Article 7; (e) comply with the competition rules referred to in Chapter V; (f) do not abuse a dominant position on a given market; and (g) provide relevant details of their membership, governance and sources of funding. 2. Producer organisations recognised before 29 December 2013 shall be considered to be producer organisations for the purposes of this Regulation, and to be bound by its provisions. Article 15 Financial support to producer organisations or associations of producer organisations Marketing measures for fishery and aquaculture products which aim to create or restructure producer organisations or associations of producer organisations may be financially supported in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014\u20132020. Article 16 Recognition of inter-branch organisations 1. Member States may recognise as inter-branch organisations the groups of operators established on their territory which apply for such recognition, provided that they: (a) comply with the principles set out in Article 17 and with the rules adopted for their application; (b) represent a significant share of production activity and of either processing or marketing activities or of both, concerning fishery and aquaculture products or products processed from fishery and aquaculture products; (c) are not themselves engaged in the production, processing or marketing of fishery and aquaculture products or products processed from fishery and aquaculture products; (d) have legal personality under the national law of a Member State, are established there and have their official headquarters in its territory; (e) are capable of pursuing the objectives laid down in Article 12; (f) take into account the interest of consumers; (g) do not hinder the sound operation of the CMO; and (h) comply with the competition rules referred to in Chapter V. 2. Organisations established before 29 December 2013 may be recognised as inter-branch organisations for the purposes of this Regulation provided that the Member State concerned is satisfied that they comply with the provisions of this Regulation regarding inter-branch organisations. 3. Inter-branch organisations recognised before 29 d\u00e9cembre 2013 shall be considered to be inter-branch organisations for the purposes of this Regulation and to be bound by its provisions. Article 17 Internal functioning of producer organisations and inter-branch organisations The internal functioning of producer organisations and inter-branch organisations referred to in Articles 14 and 16 shall be based on the following principles: (a) compliance by its members with the rules adopted by the organisation in terms of fisheries exploitation, production and marketing; (b) non-discrimination among members, particularly on grounds of nationality or place of establishment; (c) the levying of a financial contribution from its members in order to finance the organisation; (d) a democratic functioning that enables the members to scrutinise their organisation and its decisions; (e) the imposition of effective, dissuasive and proportionate penalties for infringement of obligations laid down in the internal rules of the organisation concerned, particularly in the case of \u2013non payment of financial contributions; (f) the definition of rules on the admission of new members and the withdrawal of membership; (g) the definition of the accounting and budgetary rules necessary for the management of the organisation. Article 18 Checks and withdrawal of recognition by Member States 1. Member States shall carry out checks at regular intervals to verify that producer organisations and inter-branch organisations comply with the conditions for recognition laid down in Articles 14 and 16 respectively. A finding of non-compliance may result in the withdrawal of recognition. 2. The Member State hosting the official headquarters of a producer organisation or an inter-branch organisation which has members from different Member States, or of an association of producer organisations recognised in different Member States, shall set up the administrative cooperation needed to carry out checks on the activities of the organisation or the association concerned in collaboration with the other Member States concerned. Article 19 Allocation of fishing opportunities When performing its tasks, a producer organisation whose members are nationals of different Member States or an association of producer organisations recognised in different Member States shall comply with the provisions governing the allocation of fishing opportunities among Member States in accordance with Article 16 of Regulation (EU) No 1380/2013. Article 20 Checks by the Commission 1. In order to ensure that the conditions for recognition of producer organisations or inter-branch organisations laid down in Articles 14 and 16 respectively are complied with, the Commission may carry out checks and shall, where appropriate, request that Member States withdraw the recognition of producer organisations or inter-branch organisations. 2. Member States shall communicate to the Commission by electronic means any decision to grant or withdraw the recognition. The Commission shall make all such information publically available. Article 21 Implementing acts 1. The Commission shall adopt implementing acts concerning: (a) the time-limits and procedures and the form of applications for the recognition of producer organisations and inter-branch organisations pursuant to Articles 14 and 16 respectively, or for the withdrawal of such recognition pursuant to Article 18; (b) the format, time-limits and procedures to be applied by Member States for the communication to the Commission of any decision to grant or withdraw the recognition pursuant to Article 20(2). The implementing acts adopted under point (a) shall, where appropriate, be adapted to the special characteristics of small\u2013scale fisheries and aquaculture. 2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 43(2). SECTION III Extension of rules Article 22 Extension of rules of producer organisations 1. A Member State may make the rules agreed within a producer organisation binding on producers who are not members of the organisation and who market any of the products within the area in which the producer organisation is representative, provided that: (a) the producer organisation has been established for a period of at least one year and is considered to be representative of production and marketing, including, where relevant, the small\u2013scale and artisanal sector, in one Member State and makes an application to the competent national authorities; (b) the rules to be extended concern any of the measures for producer organisations laid down in points (a), (b) and (c) of Article 8(1), points (a) and (b) of Article 8(2) and points (a) to (e) of Article 8(3); (c) the competition rules referred to in Chapter V are complied with. 2. For the purposes of point (a) of paragraph 1, a fishery producer organisation is considered to be representative where it accounts for at least 55 % of the quantities marketed of the relevant product during the previous year in the area in which it is proposed to extend the rules. 3. For the purposes of point (a) of paragraph 1, an aquaculture producer organisation is considered to be representative where it accounts for at least 40 % of the quantities marketed of the relevant product during the previous year in the area in which it is proposed to extend the rules. 4. The rules to be extended to non-members shall apply for a period of between 60 days and 12 months. Article 23 Extension of the rules of inter-branch organisations 1. A Member State may make some of the agreements, decisions or concerted practices agreed on within an inter-branch organisation binding in the specific area or areas on other operators who do not belong to that organisation, provided that: (a) the inter-branch organisation covers at least 65 % of each of at least two of the following activities: production, processing or marketing of the relevant product during the previous year in the area or areas concerned of a Member State, and makes an application to the competent national authorities; and (b) the rules to be extended to other operators concern any of the measures for inter-branch organisations laid down in points (a) to (g) of Article 13 and do not cause any damage to other operators in the Member State concerned or the Union. 2. The extension of rules may be made binding for no more than three years, without prejudice to Article 25(4). Article 24 Liability When rules are extended to non-members in accordance with Articles 22 and 23, the Member State concerned may decide that non-members are liable to the producer organisation or the inter-branch organisation for the equivalent of all or part of the costs paid by members as a result of the application of the rules that have been extended to non-members. Article 25 Authorisation by the Commission 1. Member States shall notify the Commission of the rules which they intend to make binding on all producers or operators in the specific area or areas pursuant to Articles 22 and 23. 2. The Commission shall adopt a decision authorising the extension of the rules referred to in paragraph 1, provided that: (a) the provisions of Articles 22 and 23 are complied with; (b) the competition rules referred to in Chapter V are complied with; (c) the extension does not jeopardise free trade; and (d) the achievement of the objectives of Article 39 TFEU is not endangered. 3. Within one month of receipt of the notification, the Commission shall take a decision authorising or refusing to authorise the extension of rules and shall inform the Member States thereof. Where the Commission has not taken a decision within one month of receipt of the notification, the extension of rules shall be deemed to have been authorised by the Commission. 4. An authorised extension of rules may continue to apply after the expiry of the initial period of time, including by tacit agreement, without an explicit renewal of the authorisation, provided that the Member State concerned has notified the Commission, at least one month before the expiry of such initial period, of the additional period of application and the Commission has either authorised such further application, or not objected to it within one month of receipt of such notification. Article 26 Withdrawal of authorisation The Commission may carry out checks and may withdraw the authorisation of extension of rules where it establishes that any of the requirements for the authorisation is not met. The Commission shall inform the Member States of such withdrawal. Article 27 Implementing acts The Commission shall adopt implementing acts concerning the format and procedure of the notification provided for in Article 25(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). SECTION IV Production and marketing planning Article 28 Production and marketing plan 1. Each producer organisation shall submit a production and marketing plan for, at least, its main marketed species to its competent national authorities for approval. Such production and marketing plans shall have the aim of achieving the objectives laid down in Articles 3 and 7. 2. The production and marketing plan shall comprise: (a) a production programme for caught or farmed species; (b) a marketing strategy to match the quantity, quality and presentation of supply to market requirements; (c) measures to be taken by the producer organisation in order to contribute to the objectives laid down in Article 7; (d) special anticipatory measures to adjust the supply of species which habitually present marketing difficulties during the year; (e) penalties applicable to members who infringe decisions adopted to implement the plan concerned. 3. The competent national authorities shall approve the production and marketing plan. Once the plan is approved, the producer organisation shall immediately implement it. 4. Producer organisations may revise the production and marketing plan and shall, in such case, submit it for approval to the competent national authorities. 5. The producer organisation shall prepare an annual report of its activities under the production and marketing plan and shall submit it to its competent national authorities for approval. 6. Producer organisations may receive financial support for the preparation and implementation of production and marketing plans in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014\u20132020. 7. Member States shall carry out checks to ensure that each producer organisation fulfils the obligations provided for in this Article. A finding of non-compliance may result in the withdrawal of recognition. Article 29 Implementing acts 1. The Commission shall adopt implementing acts concerning: (a) the format and structure of the production and marketing plan referred to in Article 28; (b) the procedure and time-limits for the submission by producer organisations and the approval by Member States of the production and marketing plans referred to in Article 28. 2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 43(2). SECTION V Stabilisation of the markets Article 30 Storage mechanism Fishery producer organisations may receive financial support for storage of fishery products listed in Annex II, provided that: (a) the conditions for storage aid, laid down in a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014-2020, are complied with; (b) the products have been placed on the market by fishery producer organisations and no buyer for them has been found at the trigger price referred to in Article 31; (c) the products meet the common marketing standards established in accordance with Article 33 and are of adequate quality for human consumption; (d) the products are stabilised or processed and stored in tanks or cages, by way of freezing, either on board vessels or in land facilities, salting, drying, marinating or, where relevant, boiling and pasteurisation, whether or not filleted, cut-up or, where appropriate, headed; (e) the products are reintroduced from storage into the market for human consumption at a later stage; (f) the products remain in storage for at least five days. Article 31 Prices triggering the storage mechanism 1. Before the beginning of each year, each fishery producer organisation may individually make a proposal for a price triggering the storage mechanism referred to in Article 30 for fishery products listed in Annex II. 2. The trigger price shall not exceed 80 % of the weighted average price recorded for the product in question in the area of activity of the producer organisation concerned during the three years immediately preceding the year for which the trigger price is fixed. 3. When determining the trigger price, account shall be taken of: (a) trends in production and demand; (b) the stabilisation of market prices; (c) the convergence of the markets; (d) the producers' incomes; (e) the interests of consumers. 4. Member States shall, upon examining the proposals of the producer organisations recognised in their territory, determine the trigger prices to be applied by those producer organisations. Those prices shall be fixed on the basis of the criteria referred to in paragraphs 2 and 3. The prices shall be made publicly available. Article 32 Implementing acts The Commission shall adopt implementing acts concerning the format of publication by Member States of the trigger prices pursuant to Article 31(4). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). CHAPTER III COMMON MARKETING STANDARDS Article 33 Establishment of common marketing standards 1. Without prejudice to Article 47, common marketing standards may be laid down for the fishery products that are listed in Annex I, regardless of their origin (Union or imported), that are intended for human consumption. 2. The standards referred to in paragraph 1 may relate to the quality, size, weight, packing, presentation or labelling of the products, and in particular to: (a) the minimum marketing sizes, taking into account the best available scientific advice; such minimum marketing sizes corresponding, where relevant, to minimum conservation reference sizes, in accordance with Article 15(10) of Regulation (EU) No 1380/2013; (b) specifications of preserved products in accordance with conservation requirements and international obligations. 3. Paragraphs 1 and 2 shall apply without prejudice to: (a) Regulation (EC) No 178/2002; (b) Regulation (EC) No 852/2004 of the European Parliament and of the Council (14); (c) Regulation (EC) No 853/2004 of the European Parliament and of the Council (15); (d) Regulation (EC) No 854/2004 of the European Parliament and of the Council (16); (e) Regulation (EC) No 882/2004 of the European Parliament and of the Council (17); (f) Council Regulation (EC) No 1005/2008 (18); and (g) Regulation (EC) No 1224/2009. Article 34 Compliance with common marketing standards 1. The products intended for human consumption for which common marketing standards are laid down may be made available on the Union market only in accordance with those standards. 2. All fishery products landed, including those that do not comply with common marketing standards, may be used for purposes other than direct human consumption, including fish meal, fish oil, pet food, food additives, pharmaceuticals or cosmetics. CHAPTER IV CONSUMER INFORMATION Article 35 Mandatory information 1. Without prejudice to Regulation (EU) No 1169/2011, fishery and aquaculture products referred to in points (a), (b), (c) and (e) of Annex I to this Regulation which are marketed within the Union, irrespective of their origin or of their marketing method, may be offered for sale to the final consumer or to a mass caterer only if appropriate marking or labelling indicates: (a) the commercial designation of the species and its scientific name; (b) the production method, in particular by the following words \"\u2026 caught \u2026\" or \"\u2026 caught in freshwater \u2026\" or \"\u2026 farmed \u2026\"; (c) the area where the product was caught or farmed, and the category of fishing gear used in capture of fisheries, as laid down in the first column of Annex III to this Regulation; (d) whether the product has been defrosted; (e) the date of minimum durability, where appropriate. The requirement in point (d) shall not apply to: (a) ingredients present in the final product; (b) foods for which freezing is a technologically necessary step in the production process; (c) fishery and aquaculture products previously frozen for health safety purposes, in accordance with Annex III, Section VIII, of Regulation (EC) No 853/2004; (d) fishery and aquaculture products which have been defrosted before the process of smoking, salting, cooking, pickling, drying or a combination of any of those processes. 2. For non-prepacked fishery and aquaculture products, the mandatory information listed in paragraph 1 may be provided for retail sale by means of commercial information such as billboards or posters. 3. Where a mixed product is offered for sale to the final consumer or to a mass caterer that consists of the same species but which has been derived from different production methods, the method for each batch shall be stated. Where a mixed product is offered for sale to the final consumer or to a mass caterer that consists of the same species but which has been derived from a variety of catch areas or fish\u2013farming countries, at least the area of the batch which is most representative in terms of quantity shall be stated, together with an indication that the products also come from different catch or fish-farming areas. 4. Member States may exempt from the requirements referred to in paragraph 1 small quantities of products sold directly from fishing vessels to consumers, provided that those do not exceed the value referred to in Article 58(8) of Regulation (EC) No 1224/2009. 5. Fishery and aquaculture products and their packages which were labelled or marked prior to 13 December 2014 and which do not comply with this Article may be marketed until such stocks have been used up. Article 36 Eco-labelling reporting After consulting Member States and stakeholders, the Commission shall, by 1 January 2015, submit to the European Parliament and to the Council a feasibility report on options for an eco-label scheme for fishery and aquaculture products, in particular on establishing such a scheme on a Union-wide basis and on setting minimum requirements for the use by Member States of a Union eco-label. Article 37 Commercial designation 1. For the purposes of Article 35(1), Member States shall draw up and publish a list of the commercial designations accepted in their territory, together with their scientific names. The list shall indicate: (a) the scientific name for each species, in accordance with the FishBase Information System or the ASFIS database of the Food and Agriculture Organization (FAO), where relevant; (b) the commercial designation: (i) the name of the species in the official language or languages of the Member State concerned; (ii) where applicable, any other name or names that are accepted or permitted locally or regionally. 2. All species of fish which constitute an ingredient of another food may be designated as \"fish\", provided that the name and presentation of such food does not refer to a specific species. 3. Any changes to the list of commercial designations accepted by a Member State shall be notified forthwith to the Commission which shall inform the other Member States thereof. Article 38 Indication of the catch or production area 1. The indication of the catch or production area in accordance with point (c) of Article 35(1) shall consist of the following: (a) in the case of fishery products caught at sea, the name in writing of the sub-area or division listed in the FAO fishing areas, as well as the name of such zone expressed in terms understandable to the consumer, or a map or pictogram showing that zone, or, by way of derogation from this requirement, for fishery products caught in waters other than the Northeast Atlantic (FAO Fishing Area 27) and the Mediterranean and Black Sea (FAO Fishing Area 37), the indication of the name of the FAO fishing area; (b) in the case of fishery products caught in freshwater, a reference to the body of water of origin in the Member State or third country of provenance of the product; (c) In the case of aquaculture products, a reference to the Member State or third country in which the product reached more than half of its final weight or stayed for more than half of the rearing period or, in the case of shellfish, underwent a final rearing or cultivation stage of at least six months. 2. In addition to the information referred to in paragraph 1, operators may indicate a more precise catch or production area. Article 39 Additional voluntary information 1. In addition to the mandatory information required pursuant to Article 35, the following information may be provided on a voluntary basis, provided that it is clear and unambiguous: (a) the date of catch of fishery products or the date of harvest of aquaculture products; (b) the date of landing of fishery products or information on the port at which the products were landed; (c) more detailed information on the type of fishing gear, as listed in the second column of Annex III; (d) in the case of fishery products caught at sea, details of the flag State of the vessel that caught those products; (e) environmental information; (f) information of an ethical or social nature; (g) information on production techniques and practices; (h) information on the nutritional content of the product. 2. A Quick Response (QR) code may be used outlining part or all of the information listed in Article 35(1). 3. Voluntary information shall not be displayed to the detriment of the space available for mandatory information on the marking or labelling. 4. No voluntary information shall be included that cannot be verified. CHAPTER V COMPETITION RULES Article 40 Application of competition rules Articles 101 to 106 TFEU and their implementing provisions shall apply to agreements, decisions and practices referred to in Article 101(1) and Article 102 TFEU which relate to production or marketing of fishery and aquaculture products. Article 41 Exceptions to the application of competition rules 1. Notwithstanding Article 40 of this Regulation, Article 101(1) TFEU shall not apply to agreements, decisions and practices of producer organisations which concern the production or sale of fishery and aquaculture products, or the use of joint facilities for the storage, treatment or processing of fishery and aquaculture products, and which: (a) are necessary to attain the objectives set out in Article 39 TFEU; (b) do not imply any obligation to charge identical prices; (c) do not lead to the partitioning of markets in any form within the Union; (d) do not exclude competition; and (e) do not eliminate competition in respect of a substantial proportion of the products in question. 2. Notwithstanding Article 40 of this Regulation, Article 101(1) TFEU shall not apply to agreements, decisions and practices of inter-branch organisations which: (a) are necessary to attain the objectives set out in Article 39 TFEU; (b) do not entail any obligation to apply a fixed price; (c) do not lead to the partitioning of markets in any form within the Union; (d) do not apply dissimilar conditions to equivalent transactions with other trading partners, thereby placing them at a competitive disadvantage; (e) do not eliminate competition in respect of a substantial proportion of the products in question; and (f) do not restrict competition in ways which are not essential for the achievement of the objectives of the CFP. CHAPTER VI MARKET INTELLIGENCE Article 42 Market Intelligence 1. The Commission shall: (a) gather, analyse and disseminate economic knowledge and understanding of the Union market for fishery and aquaculture products along the supply chain, taking into account the international context; (b) provide practical support to producer organisations and inter-branch organisations to better coordinate information between operators and processors; (c) regularly survey prices for fishery and aquaculture products in the Union market along the supply chain and conduct analyses on market trends; (d) conduct ad-hoc market studies and provide a methodology for price formation surveys. 2. In order to implement paragraph 1, the Commission shall make use of the following measures: (a) facilitate access to available data on fishery and aquaculture products collected pursuant to Union law; (b) make market information, such as price surveys, market analyses and studies, available to all the stakeholders and to the general public in an accessible and understandable manner, subject to Regulation (EC) No 45/2001 of the European Parliament and of the Council (19). 3. Member States shall contribute to the achievement of the objectives referred to in paragraph 1. CHAPTER VII PROCEDURAL PROVISIONS Article 43 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. CHAPTER VIII FINAL PROVISIONS Article 44 Amendment to Regulation (EC) No 1184/2006 Article 1 of Regulation (EC) No 1184/2006 is replaced by the following: \"Article 1 This Regulation lays down rules concerning the applicability of Articles 101 to 106 and of Article 108(1) and (3) of the Treaty on the functioning of the European Union (TFEU) in relation to production of, or trade in, the products listed in Annex I to the TFEU with the exception of the products covered by Council Regulation (EC) No 1234/2007 (20) and Regulation (EU) No 1379/2013 of the European Parliament and of the Council (21). Article 45 Amendments to Regulation (EC) No 1224/2009 Regulation (EC) No 1224/2009 is hereby amended as follows: (1) in Article 57(1), the following sentences are added: \"Member States shall undertake checks to ensure compliance. The checks may take place at all marketing stages and during transport.)\" (2) Article 58(5) is amended as follows: (a) point (g) is replaced by the following: \"(g) the information to consumers provided for in Article 35 of Regulation (EU) No 1379/2013 of the European Parliament and of the Council (22); (b) point (h) is deleted. Article 46 Repeal Regulation (EC) No 104/2000 is hereby repealed. However, Article 4 shall apply until 12 December 2014. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex IV. Article 47 Rules establishing common marketing standards Rules establishing common marketing standards, in particular Council Regulation (EEC) No 2136/89 (23), Council Regulation (EEC) No 1536/92 (24), Council Regulation (EC) No 2406/96 (25), as well as other rules adopted for the application of common marketing standards, such as Commission Regulation (EEC) No 3703/85 (26), shall continue to apply. Article 48 Review The Commission shall report to the European Parliament and the Council on the results of the application of this Regulation by 31 December 2022. Article 49 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014, with the exception of Chapter IV and Article 45 which shall apply from 13 December 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 December 2013. For the European Parliament The President M. SCHULZ For the Council The President V. LE\u0160KEVI\u010cIUS (1) OJ C 181, 21.6.2012, p. 183. (2) OJ C 225, 27.7.2012, p. 20. (3) Position of the European Parliament of 12 September 2012 (not yet published in the Official Journal) and position of the Council at first reading of 17 October 2013 (not yet published in the Official Journal). Position of the European Parliament of 9 December 2013 (not yet published in the Official Journal). (4) Council Regulation (EC) No 104/2000 of 17 December 1999 on the common organisation of the markets in fishery and aquaculture products (OJ L 17, 21.1.2000, p. 22). (5) Council Regulation (EC) No 1184/2006 of 24 July 2006 applying certain rules of competition to the production of, and trade in, agricultural products (OJ L 214, 4.8.2006, p. 7). (6) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (7) Council Regulation (EU) No 1220/2012 of 3 December 2012 on trade related measures to guarantee the supply of certain fishery products to Union processors from 2013 to 2015, amending Regulations (EC) No 104/2000 and (EU) No 1344/2011 (OJ L 349, 19.12.2012, p. 4). (8) Regulation (EU) No 1026/2012 of the European Parliament and of the Council of 25 October 2012 on certain measures for the purpose of the conservation of fish stocks in relation to countries allowing non-sustainable fishing (OJ L 316, 14.11.2012, p. 34). (9) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 december 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (See page 22 of this Official Journal). (10) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (11) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). (12) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (13) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16). (14) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1). (15) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55). (16) Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (OJ L 226, 25.6.2004, p. 83). (17) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). (18) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (19) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (20) Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (OJ L 299, 16.11.2007, p. 1). (21) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 december 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, p. 1)\". (22) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 december 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, p. 1).)\" (23) Council Regulation (EEC) No 2136/89 of 21 June 1989 laying down common marketing standards for preserved sardines and trade descriptions for preserved sardines and sardine-type products (OJ L 212, 22.7.1989, p. 79). (24) Council Regulation (EEC) No 1536/92 of 9 June 1992 laying down common marketing standards for preserved tuna and bonito (OJ L 163, 17.6.1992, p. 1). (25) Council Regulation (EC) 2406/96 of 26 November 1996 laying down common marketing standards for certain fishery products (OJ L 334, 23.12.1996, p. 1). (26) Commission Regulation (EEC) No 3703/85 of 23 December 1985 laying down detailed rules for applying the common marketing standards for certain fresh or chilled fish (OJ L 351, 28.12.1985, p. 63). ANNEX I FISHERY AND AQUACULTURE PRODUCTS COVERED BY THE CMO CN code Description of the goods (a) 0301 Live fish 0302 Fish, fresh or chilled, excluding fish fillets and other fish meat of heading 0304 0303 Fish, frozen, excluding fish fillets and other fish meat of heading 0304 0304 Fish fillets and other fish meat (whether or not minced), fresh, chilled or frozen (b) 0305 Fish, dried, salted or in brine; smoked fish, whether or not cooked before or during the smoking process; flours, meals and pellets of fish, fit for human consumption (c) 0306 Crustaceans, whether in shell or not, live, fresh, chilled, frozen, dried, salted or in brine; crustaceans, in shell, cooked by steaming or by boiling in water, whether or not chilled, frozen, dried, salted or in brine; flours, meals and pellets of crustaceans, fit for human consumption 0307 Molluscs, whether in shell or not, live, fresh, chilled, frozen, dried, salted or in brine; aquatic invertebrates other than crustaceans and molluscs, live, fresh, chilled, frozen, dried, salted or in brine; flours, meals and pellets of aquatic invertebrates other than crustaceans, fit for human consumption (d) Animal products not elsewhere specified or included; dead animals of Chapter 1 or 3, unfit for human consumption Other: Products of fish or crustaceans, molluscs or other aquatic invertebrates; dead animals of Chapter 3: 0511 91 10 Fish waste 0511 91 90 Other (e) 1212 20 00 Seaweeds and other algae (f) Fats and oils and their fractions, of fish, whether or not refined, but not chemically modified: 1504 10 Fish-liver oils and their fractions 1504 20 Fats and oils and their fractions, of fish, other than liver oils (g) 1603 00 Extracts and juices of meat, fish or crustaceans, molluscs or other aquatic invertebrates (h) 1604 Prepared or preserved fish; caviar and caviar substitutes prepared from fish eggs (i) 1605 Crustaceans, molluscs and other aquatic invertebrates, prepared or preserved (j) Pasta, whether or not cooked or stuffed (with meat or other substances) or otherwise prepared, such as spaghetti, macaroni, noodles, lasagne, gnocchi, ravioli, cannelloni; couscous, whether or not prepared 1902 20 Stuffed pasta, whether or not cooked or otherwise prepared: 1902 20 10 Containing more than 20 % by weight of fish, crustaceans, molluscs or other aquatic invertebrates (k) Flours, meals and pellets, of meat or meat offal, of fish or of crustaceans, molluscs or other aquatic invertebrates, unfit for human consumption; greaves: 2301 20 00 Flours, meals and pellets, of fish or of crustaceans, molluscs or other aquatic invertebrates (l) Preparations of a kind used in animal feeding 2309 90 Other: ex 2309 90 10 Fish solubles ANNEX II FISHERY PRODUCTS SUBJECT TO THE STORAGE MECHANISM CN Code Description of the goods 0302 22 00 Plaice (Pleonectes platessa) ex 0302 29 90 Dab (Limanda limanda) 0302 29 10 Megrim (Lepidorhombus spp.) ex 0302 29 90 Flounder (Platichthys flesus) 0302 31 10 and 0302 31 90 Albacore or longfinned tunas (Thunnus alalunga) ex 0302 40 Herring of the species Clupea harengus 0302 50 10 Cod of the species Gadus morhua 0302 61 10 Sardines of the species Sardina pilchardus ex 0302 61 80 Sprat (Sprattus sprattus) 0302 62 00 Haddock (Melanogrammus aeglefinus) 0302 63 00 Coalfish (Pollachius virens) ex 0302 64 Mackerel of the species Scomber scombrus and Scomber japonicus 0302 65 20 and 0302 65 50 Dogfish (Squalus acanthias and Scyliorhinus spp.) 0302 69 31 and 0302 69 33 Redfish (Sebastes spp.) 0302 69 41 Whiting (Merlangius merlangus) 0302 69 45 Ling (Molva spp.) 0302 69 55 Anchovies (Engraulis spp.) ex 0302 69 68 Hake of the species Merluccius merluccius 0302 69 81 Monkfish (Lophius spp.) ex 0302 69 99 Dolphin-fish (Coryphaena hippurus) ex 0307 41 10 Cuttlefish (Sepia officinalis and Rossia macrosoma) ex 0306 23 10 ex 0306 23 31 ex 0306 23 39 Shrimps of the species Crangon crangon and deepwater prawn (Pandalus borealis) 0302 23 00 Sole (Solea spp.) 0306 24 30 Edible crabs (Cancer pagurus) 0306 29 30 Norway lobsters (Nephrops norvegicus) 0303 31 10 Lesser or Greenland halibut (Reinhardtius hipoglossoides) 0303 78 11 0303 78 12 0303 78 13 0303 78 19 and 0304 29 55 0304 29 56 0304 29 58 Hake of the genus Merluccius 0303 79 71 Sea bream (Dentex dentex and Pagellus spp.) 0303 61 00 0304 21 00 0304 91 00 Swordfish (Xiphias gladius) 0306 13 40 0306 13 50 ex 0306 13 80 Shrimps of the family Penaeidae 0307 49 18 0307 49 01 Cuttlefish of the species Sepia officinalis, Rossia macrosoma and Sepiola rondeletti 0307 49 31 0307 49 33 0307 49 35 and 0307 49 38 Squid (Loligo spp.) 0307 49 51 Squid (Ommastrephes sagittatus) 0307 59 10 Octopus (Octopus spp.) 0307 99 11 Illex spp. 0303 41 10 Albacore or longfinned tuna (Thunnus alalunga) 0302 32 10 0303 42 12 0303 42 18 0303 42 42 0303 42 48 Yellowfin tunas (Thunnus albacares) 0302 33 10 0303 43 10 Skipjack or stripe-bellied bonito (Katsuwomus pelamis) 0303 45 10 Bluefin tuna (Thunnus thynnus) 0302 39 10 0302 69 21 0303 49 30 0303 79 20 Other species of the genera Thunnus and Euthynnus ex 0302 29 90 Lemon sole (Microstomus kitt) 0302 35 10 and 0302 35 90 Bluefin tunas (Thunnus thynnus) ex 0302 69 51 Pollack (Pollachius pollachius) 0302 69 75 Ray's bream (Brama spp.) ex 0302 69 82 Blue whiting (Micromesistius poutassou) ex 0302 69 99 Pout (Trisopterus luscus) and poor cod (Trisopterus minutus) ex 0302 69 99 Bogues (Boops boops) ex 0302 69 99 Picarel (Spicara smaris) ex 0302 69 99 Conger (Conger conger) ex 0302 69 99 Gurnard (Trigla spp.) ex 0302 69 91 ex 0302 69 99 Horse mackerel (Trachurus spp.) ex 0302 69 99 Mullet (Mugil spp.) ex 0302 69 99 and ex 0304 19 99 Skate (Raja spp.) ex 0302 69 99 Scabbard fish (Lepidopus caudatus and Aphanopus carbo) ex 0307 21 00 Common scallop (Pecten maximus) ex 0307 91 00 Common whelk (Buccinum undatum) ex 0302 69 99 Striped or red mullet (Mullus surmuletus, Mullus barbatus) ex 0302 69 99 Black sea bream (Spondyliosoma cantharus) ANNEX III INFORMATION ON FISHING GEAR Mandatory information on the category of fishing gear More detailed information on corresponding gears and codes, in accordance with Commission Regulation (EC) No 26/2004 (1) and Commission Implementing Regulation (EU) No 404/2011 (2) Seines Beach seines SB Danish seines SDN Scottish seines SSC Pair seines SPR Trawls Beam trawls TBB Bottom otter trawls OTB Bottom pair trawls PTB Midwater otter trawls OTM Pelagic pair trawls PTM Otter twin trawls OTT Gillnets and similar nets Set (anchored) gillnets GNS Driftnets GND Encircling gillnets GNC Trammel nets GTR Combined trammel and gillnets GTN Surrounding nets and lift nets Purse seines PS Lampara nets LA Boat operated lift nets LNB Shore-operated stationary lift nets LNS Hooks and lines Hand lines and pole lines (hand operated) LHP Hand lines and pole lines (mechanised) LHM Set longlines LLS Longlines (drifting) LLD Troll lines LTL Dredges Boat dredges DRB Hand dredges used on board a vessel DRH Mechanised dredges including suction dredges HMD Pots and traps Pots (traps) FPO (1) Commission Regulation (EC) No 26/2004 of 30 December 2003 on the Community fishing fleet register (OJ L 5, 9.1.2004, p. 25). (2) Commission Implementing Regulation (EU) No 404/2011 of 8 April 2011 laying down detailed rules for the implementation of Council Regulation (EC) No 1224/2009 establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy (OJ L 112, 30.4.2011, p. 1). ANNEX IV CORRELATION TABLE Regulation (EC) No 104/2000 This Regulation Article 1 Articles 1 to 5 Articles 2 and 3 Articles 33 and 34 Article 4 Articles 35 to 39 Article 5(1) Articles 6, 7, 8, Article 5(2), 5(3), 5(4) and Article 6 Articles 14, 18 to 21 Article 7 Articles 22 and 24 to 27 Article 8 \u2014 Articles 9 to 12 Articles 28, 29 Article 13 Articles 11, 12, 13, 16, 18, 20 and 21 Article 14 Article 41(2) Article 15 Article 23 Article 16 Articles 24 to 27 Articles 17 to 27 Articles 30, 31 and 32 Article 33 \u2014 Article 34 Articles 20(2), 21 and 32 Article 35 \u2014 Article 36 \u2014 Article 37 Article 43 Articles 38 and 39 Article 43 Article 40 \u2014 Article 41 Article 48 Article 42 Articles 44, 45 and 46 Article 43 Article 49 \u2014 Article 40 \u2014 Article 41(1) \u2014 Article 42", "summary": "EU market for fishery and aquaculture products EU market for fishery and aquaculture products SUMMARY OF: Regulation (EU) No 1379/2013 \u2014 common organisation of the markets in fishery and aquaculture products WHAT IS THE AIM OF THE REGULATION? As part of the reform of the EU\u2019s common fisheries policy (CFP), the regulation revises the aims and regulation of the common organisation of the markets of fishery and aquaculture (fish and shellfish farming) products. KEY POINTS The scheme covers 5 main areas: professional organisations; marketing standards; consumer information; competition rules; market intelligence (collecting and analysing relevant market data to use as a basis for decision-making). Professional organisations The regulation sets out a number of specific aims for producer organisations including promoting sustainable fishing and reducing discards. The reform also focuses on the collective management of activities through production and marketing plans. The rules and structure of these plans are set out in a subsequent implementing regulation, and the European Commission has set out recommendations to facilitate the role of competent national authorities in this respect. Rules on the recognition of producer organisations and inter-branch organisations are set out in the text and in a further implementing regulation. Marketing standards Common marketing standards are established for fishery products regardless of whether their origin is from within or outside of the EU. Those fishery products that do not comply with these standards may still be used for purposes other than direct human consumption (for example, petfood, cosmetics). Consumer information Labelling for consumers must indicate: the commercial name of the species (the name or names accepted or permitted locally or regionally in a country) and its scientific name; the production method; where the product was caught or farmed and the type of fishing gear used; whether the product has been defrosted; the expiry date, where appropriate. Competition rules The common organisation of the markets is subject to EU competition rules, but there are certain exceptions to ensure the proper functioning of the policy and the achievement of EU objectives (e.g. adjustment of members\u2019 level of production). Market intelligence The Commission is to provide market intelligence for professional organisations, stakeholders and policymakers through the dissemination of economic knowledge, market analysis and price monitoring. COVID-19 pandemic \u2014 amendment to the regulation Regulation (EU) 2020/560 amends Regulation (EU) No 1379/2013 introducing specific measures to mitigate the impact of the COVID-19 pandemic. There has been a significant drop in demand for fishery and aquaculture products following the COVID-19 pandemic with serious socio-economic consequences in those communities where fishing and aquaculture play a major role. The amended regulation aims to allow a more flexible redistribution of financial resources within operational programmes in each EU country and to simplify the procedure for amending operational programmes when introducing new measures. Given the important role of producer organisations in managing the crisis, the ceiling for financial support to production and marketing plans is substantially increased and EU countries are allowed to grant advances of up to 100% of that financial support. In addition, the possibility to use the storage aid mechanism was extended to aquaculture producer organisations, FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND This regulation is the second of 3 elements in the legislative package of CFP reform. It accompanies Regulation (EU) No 1380/2013 on the CFP (see summary) and Regulation (EU) No 508/2014 on the European and Maritime Fisheries Fund (see summary). For more information, see: Market organisation (European Commission) Communication from the Commission \u2014Temporary Framework for State aid measures to support the economy in the current COVID-19 outbreak (European Commission). MAIN DOCUMENT Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, pp. 1-21) Successive amendments to Regulation (EU) No 1379/2013 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Recommendation 2014/117/EU of 3 March 2014 on the establishment and implementation of the Production and Marketing Plans pursuant to Regulation (EU) No 1379/2013 of the European Parliament and of the Council on the common organisation of the markets in fishery and aquaculture products (OJ L 65, 5.3.2014, pp. 31-38) Commission Implementing Regulation (EU) No 1418/2013 of 17 December 2013 concerning production and marketing plans pursuant to Regulation (EU) No 1379/2013 of the European Parliament and of the Council on the common organisation of the markets in fishery and aquaculture products (OJ L 353, 28.12.2013, pp. 40-42) Commission Implementing Regulation (EU) No 1419/2013 of 17 December 2013 concerning the recognition of producer organisations and inter-branch organisations, the extension of the rules of producer organisations and inter-branch organisations and the publication of trigger prices as provided for by Regulation (EU) No 1379/2013 of the European Parliament and of the Council on the common organisation of the markets in fishery and aquaculture products (OJ L 353, 28.12.2013, pp. 43-47) See consolidated version. Commission Implementing Regulation (EU) No 1420/2013 of 17 December 2013 repealing Regulations (EC) No 347/96, (EC) No 1924/2000, (EC) No 1925/2000, (EC) No 2508/2000, (EC) No 2509/2000, (EC) No 2813/2000, (EC) No 2814/2000, (EC) No 150/2001, (EC) No 939/2001, (EC) No 1813/2001, (EC) No 2065/2001, (EC) No 2183/2001, (EC) No 2318/2001, (EC) No 2493/2001, (EC) No 2306/2002, (EC) No 802/2006, (EC) No 2003/2006, (EC) No 696/2008 and (EC) No 248/2009 following the adoption of Regulation (EU) No 1379/2013 of the European Parliament and of the Council on the common organisation of the markets in fishery and aquaculture products (OJ L 353, 28.12.2013, pp. 48-50) last update 04.06.2020"}
{"article": "28.8.2014 EN Official Journal of the European Union L 257/1 REGULATION (EU) No 909/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 July 2014 on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Central securities depositories (CSDs), together with central counterparties (CCPs) contribute to a large degree in maintaining post-trade infrastructures that safeguard financial markets and give market participants confidence that securities transactions are executed properly and in a timely manner, including during periods of extreme stress. (2) Due to their key position in the settlement process, the securities settlement systems operated by CSDs are of a systemic importance for the functioning of securities markets. Playing an important role in the securities holding systems through which their participants report the securities holdings of investors, the securities settlement systems operated by CSDs also serve as an essential tool to control the integrity of an issue, hindering the undue creation or reduction of issued securities, and thereby play an important role in maintaining investor confidence. Moreover, securities settlement systems operated by CSDs are closely involved in securing collateral for monetary policy operations as well as in securing collateral between credit institutions and are, therefore, important actors in the collateralisation process. (3) While Directive 98/26/EC of the European Parliament and of the Council (4) reduced the disruption to a securities settlement system caused by insolvency proceedings against a participant in that system, it is necessary to address other risks that securities settlement systems are facing, as well as the risk of insolvency or disruption in the functioning of the CSDs that operate securities settlement systems. A number of CSDs are subject to credit and liquidity risks deriving from the provision of banking services ancillary to settlement. (4) The increasing number of cross-border settlements as a consequence of the development of link agreements between CSDs calls into question the resilience, in the absence of common prudential rules, of CSDs when importing the risks encountered by CSDs from other Member States. Moreover, despite the increase in cross-border settlements, market-driven changes towards a more integrated market for CSD services have proven to be very slow. An open internal market in securities settlement should allow any investor in the Union to invest in all Union securities with the same ease as in, and using the same processes as for, domestic securities. However, the settlement markets in the Union remain fragmented across national borders and cross-border settlement remains more costly, due to different national rules regulating settlement and the activities of CSDs and limited competition between CSDs. That fragmentation hinders and creates additional risks and costs for cross-border settlement. Given the systemic relevance of CSDs, competition between them should be promoted so as to enable market participants a choice of provider and reduce reliance on any one infrastructure provider. In the absence of identical obligations for market operators and common prudential standards for CSDs, divergent measures likely to be taken at national level will have a direct negative impact on the safety, efficiency and competition in the settlement markets in the Union. It is necessary to remove those significant obstacles in the functioning of the internal market and avoid distortions of competition and to prevent such obstacles and distortions from arising in the future. The creation of an integrated market for securities settlement with no distinction between national and cross-border securities transactions is needed for the proper functioning of the internal market. Consequently, the appropriate legal basis for this Regulation should be Article 114 of the Treaty on the Functioning of the European Union (TFEU), as interpreted in accordance with the consistent case law of the Court of Justice of the European Union. (5) It is necessary to lay down in a regulation a number of uniform obligations to be imposed on market participants regarding certain aspects of the settlement cycle and discipline and to provide a set of common requirements for CSDs operating securities settlement systems. The directly applicable rules of a regulation should ensure that all market operators and CSDs are subject to identical directly applicable obligations, standards and rules. A regulation should increase the safety and efficiency of settlement in the Union by preventing any diverging national rules as a result of the transposition of a directive. A regulation should reduce the regulatory complexity for market operators and CSDs resulting from different national rules and should allow CSDs to provide their services on a cross-border basis without having to comply with different sets of national requirements such as those concerning the authorisation, supervision, organisation or risks of CSDs. A regulation imposing identical requirements on CSDs should also contribute to eliminating competitive distortions. (6) On 20 October 2010, the Financial Stability Board called for more robust core market infrastructures and asked for the revision and enhancement of the existing standards. In April 2012, the Committee on Payments and Settlement Systems (CPSS) of the Bank of International Settlements (BIS) and the International Organisation of Securities Commissions (IOSCO) adopted global standards for financial market infrastructures. Those standards have replaced the BIS recommendations of 2001, which were adapted through non-binding guidelines at European level in 2009 by the European System of Central Banks (ESCB) and the Committee of European Securities Regulators. Taking into account the global nature of financial markets and the systemic importance of CSDs, it is necessary to ensure international convergence of the prudential requirements to which they are subject. This Regulation should follow the existing principles for financial market infrastructures developed by CPSS-IOSCO. The Commission and the European Supervisory Authority (European Securities and Markets Authority) (\u2018ESMA\u2019), established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (5), in close cooperation with the members of the ESCB, should ensure consistency with the existing standards and their future developments when drawing up or proposing to revise the regulatory technical standards and the implementing technical standards as well as the guidelines and recommendations referred to in this Regulation. (7) The Council, in its conclusions of 2 December 2008, emphasised the need to strengthen the safety and soundness of the securities settlement systems, and to address legal barriers to post-trading in the Union. (8) One of the basic tasks of the ESCB is to promote the smooth operation of payment systems. In this respect, the members of the ESCB execute oversight by ensuring efficient and sound clearing and payment systems. The members of the ESCB often act as settlement agents for the cash leg of securities transactions. They are also significant clients of CSDs, which often manage the collateralisation of monetary policy operations. The members of the ESCB should be closely involved, by being consulted, in the authorisation and supervision of CSDs, the recognition of third-country CSDs and the approval of certain CSD links. To prevent the emergence of parallel sets of rules, they should also be closely involved by being consulted in the setting of regulatory and implementing technical standards as well as of guidelines and recommendations although primary responsibility for the setting of such technical standards, guidelines and recommendations should rest with the Commission and ESMA, as laid down in this Regulation. This Regulation should be without prejudice to the responsibilities of the European Central Bank (ECB) and the national central banks to ensure efficient and sound clearing and payment systems within the Union and other countries. This Regulation should not prevent the members of the ESCB from accessing the information relevant for the performance of their duties, including the oversight of CSDs and other financial market infrastructures. (9) The members of the ESCB, any other bodies performing similar functions in certain Member States or other public bodies charged with or intervening in the management of the public debt in the Union may themselves provide a number of services, such as operating a securities settlement system, which would qualify them as a CSD. Such entities, when acting as CSDs without establishing a separate entity, should be exempt from the authorisation and supervision requirements, certain organisational requirements and capital and investment policy requirements, but should remain subject to the remaining prudential requirements for CSDs. Where such Member State entities act as CSDs, they should not provide their services in other Member States. Since the members of the ESCB act as settlement agents for the purpose of settlement, they should also be exempt from the requirements set out in Title IV of this Regulation. (10) This Regulation should apply to the settlement of transactions in all financial instruments and activities of CSDs unless specified otherwise. This Regulation should also be without prejudice to other legislation of the Union concerning specific financial instruments such as Directive 2003/87/EC of the European Parliament and of the Council (6) and measures adopted in accordance with that Directive. (11) The recording of securities in book-entry form is an important step towards increasing the efficiency of settlement and ensuring the integrity of a securities issue, especially in a context of increasing complexity of holding and transfer methods. For reasons of safety, this Regulation provides for the recording in book-entry form of all transferable securities admitted to trading or traded on the trading venues regulated by Directive 2014/65/EU of the European Parliament and of the Council (7) and by Regulation (EU) No 600/2014 of the European Parliament and of the Council (8). This Regulation should not impose one particular method for the initial book-entry recording, which should be able to take the form of immobilisation or of immediate dematerialisation. This Regulation should not impose the type of institution that is to record securities in book-entry form upon issuance but, rather, should permit different actors, including registrars, to perform that function. However, once transactions in such securities are executed on trading venues regulated by Directive 2014/65/EU and Regulation (EU) No 600/2014 or provided as collateral under the conditions laid down in Directive 2002/47/EC of the European Parliament and of the Council (9), such securities should be recorded in a CSD book-entry system in order to ensure, inter alia, that all such securities can be settled in a securities settlement system. Immobilisation and dematerialisation should not imply any loss of rights for the holders of securities and should be achieved in a way that ensures that holders of securities can verify their rights. (12) In order to ensure the safety of settlement, any participant in a securities settlement system buying or selling certain financial instruments, namely transferable securities, money-market instruments, units in collective investment undertakings and emission allowances, should settle its obligation on the intended settlement date. (13) Longer settlement periods for transactions in transferable securities cause uncertainty and increased risk for securities settlement systems participants. Different durations of settlement periods across Member States hamper reconciliation and are sources of errors for issuers, investors and intermediaries. It is therefore necessary to provide a common settlement period which would facilitate the identification of the intended settlement date and facilitate the implementation of settlement discipline measures. The intended settlement date of transactions in transferable securities which are executed on trading venues regulated by Directive 2014/65/EU and Regulation (EU) No 600/2014 should be no later than on the second business day after the trading takes place. For complex operations composed of several transactions such as securities repurchase or lending agreements, that requirement should apply to the first transaction involving a transfer of securities. Given their non-standardised character, that requirement should not apply to transactions that are negotiated privately by the relevant parties, but executed on the trading venues regulated by Directive 2014/65/EU and Regulation (EU) No 600/2014 or to transactions that are executed bilaterally, but reported to a trading venue regulated by Directive 2014/65/EU and Regulation (EU) No 600/2014. Moreover, that requirement should not apply to the first transaction where the transferable securities concerned are subject to initial recording in book-entry form. (14) CSDs and other market infrastructures should take measures to prevent and address settlement fails. It is essential that such rules be uniformly and directly applied in the Union. In particular, CSDs and other market infrastructures should be required to put in place procedures enabling them to take appropriate measures to suspend any participant that systematically causes settlement fails and to disclose its identity to the public, provided that that participant has the opportunity to submit observations before such a decision is taken. (15) One of the most efficient ways to address settlement fails is to require failing participants to be subject to a compulsory enforcement of the original agreement. This Regulation should provide for uniform rules concerning penalties and certain aspects of the buy-in transaction for all transferable securities, money-market instruments, units in collective investment undertakings and emission allowances, such as timing and pricing. Those rules should be adapted to the specificities of different securities markets, certain trading venues such as SME growth markets as defined in Directive 2014/65/EU and certain complex operations such as very short-term securities repurchase or lending agreements, in order to avoid adversely impacting on the liquidity and efficiency of securities markets. The rules on settlement discipline should be applied in a manner that provides an incentive for the settlement of transactions in all relevant financial instruments by their intended settlement date. (16) The procedures and penalties relating to settlement fails should be commensurate with the scale and seriousness of such fails whilst being scaled in such a way that maintains and protects the liquidity of the relevant financial instruments. In particular, market-making activities play a crucial role in providing liquidity to markets within the Union, particularly to less liquid securities. Measures to prevent and address settlement fails should be balanced against the need to maintain and protect liquidity in those securities. Cash penalties imposed on failing participants should, where possible, be credited to the non-failing clients as compensation and should not, in any event, become a source of revenue for the CSD concerned. CSDs should consult the market infrastructures in respect of which they provide CSD services on the implementation of settlement discipline measures laid down in this Regulation. (17) In most cases a buy-in process should be initiated where the financial instruments are not delivered within four business days of the intended settlement date. However, for illiquid financial instruments it is appropriate that the period before initiating the buy-in process should be increased to a maximum of seven business days. The basis for determining when financial instruments are deemed to be illiquid should be established through regulatory technical standards, taking account of the assessments already made in Regulation (EU) No 600/2014. Where such a determination is made the extension of the deadline for initiating the buy-in process should be up to seven business days. (18) It is appropriate to allow SME growth markets the flexibility not to apply the buy-in process until up to 15 days after the trade has taken place so as to take into account the liquidity of such markets and to allow, in particular, for activity by market-makers in those less liquid markets. The settlement discipline measures specific to SME growth markets should apply only to transactions executed on such markets. As identified in the Commission Staff Working Paper of 7 December 2011 accompanying the Commission communication entitled, \u2018An action plan to improve access to finance for SMEs\u2019, access to capital markets should be developed as an alternative to bank lending to SMEs and it is therefore appropriate to tailor the rules to better serve the needs of those SME growth markets. (19) CSDs should be allowed to monitor the execution of a buy-in with respect to multiple settlement instructions on the same financial instruments and with the same date of expiry of the extension period with the aim of minimising the number of buy-ins to the extent compatible with the requirements of this Regulation. (20) As the main purpose of this Regulation is to introduce a number of legal obligations imposed directly on market operators consisting, inter alia, of the recording in book-entry form in CSDs of all transferable securities once such securities are traded on trading venues regulated by Directive 2014/65/EU and Regulation (EU) No 600/2014 or provided as collateral under the conditions of Directive 2002/47/EC and in the settling of their obligations no later than on the second business day after trading takes place and as CSDs are responsible for the operation of securities settlement systems and the application of measures to provide timely settlement in the Union, it is essential to ensure that all CSDs are safe and sound and comply at all times with stringent organisational, conduct of business and prudential requirements laid down in this Regulation, including by taking all reasonable steps to mitigate fraud and negligence. Uniform and directly applicable rules regarding the authorisation and ongoing supervision of CSDs are therefore an essential corollary of and are interrelated with the legal obligations imposed on market participants by this Regulation. It is, therefore, necessary to include rules regarding the authorisation and supervision of CSDs in the same act as the legal obligations imposed on market participants. (21) Taking into account that CSDs should be subject to common requirements and in order to dismantle the existing barriers to cross-border settlement, any authorised CSDs should enjoy the freedom to provide services within the territory of the Union, including through setting up a branch. In order to ensure an appropriate level of safety in the provision of services by CSDs in another Member State, such CSDs should be subject to a specific procedure laid down in this Regulation where they intend to provide certain core services as provided for in this Regulation or set up a branch in a host Member State. (22) Within a borderless Union settlement market, it is necessary to establish the competences of the different authorities involved in the application of this Regulation. Member States should specifically designate the competent authorities responsible for the application of this Regulation, which should be afforded the supervisory and investigatory powers necessary for the exercise of their functions. A CSD should be subject to authorisation and supervision by the competent authority of its home Member State, which is well placed and should be empowered to examine how CSDs operate on a daily basis, to carry out regular reviews and to take appropriate action when necessary. The competent authority concerned should however consult at the earliest stage and cooperate with other relevant authorities, which include the authorities responsible for the oversight of each securities settlement system operated by the CSD, the central banks that issue the most relevant settlement currencies, where applicable, the relevant central banks that act as settlement agent for each securities settlement system, and, also, where applicable, the competent authorities of other group entities. Such cooperation also implies exchanges of information between the authorities concerned and the immediate notification of those authorities in the case of an emergency situation affecting the liquidity and stability of the financial system in any of the Member States where the CSD or any of its participants is established. (23) Where a CSD provides its services in another Member State, the competent authority of the host Member State should be able to request from the competent authority of the home Member State all information concerning the activities of the CSD that is of relevance to the requesting authority. In order to enable effective coordination of supervision, that information could concern in particular the services provided to CSD users established in the host Member State or the instruments or currencies processed and may include information on adverse developments, results of risk assessments and remedial measures. The competent authority of the home Member State should also have access to any information periodically reported by the CSD to the competent authority of the host Member State. (24) Where a CSD provides its services in a Member State other than the Member State where it is established, including through setting up a branch, the competent authority of its home Member State is mainly responsible for the supervision of that CSD. When the activities of a CSD in a host Member State have become of substantial importance for the functioning of the securities markets and the protection of the investors in that host Member State, the competent authorities and relevant authorities of the home Member State and of the host Member State should establish cooperation arrangements for the supervision of the activities of that CSD in the host Member State. The competent authority of the home Member State should also be able to decide that those cooperation arrangements envisage multilateral cooperation, including cooperation of a collegial nature, between the competent authority of the home Member State and the competent authorities and relevant authorities of the host Member States concerned. Such cooperation arrangements, however, should not be considered to be colleges of supervisors as referred to in Regulation (EU) No 1095/2010. No Member State or group of Member States should be discriminated against directly or indirectly, as a location for CSD and settlement services. While performing its duties under this Regulation no authority should directly or indirectly discriminate against any undertaking from another Member State. Subject to this Regulation, a CSD from one Member State should not be restricted in or prevented from settling financial instruments in the currency of another Member State or in the currency of a third country. (25) This Regulation should not prevent Member States from requiring in their national law a specific legal framework for day-to-day cooperation at national level between the competent authority of the CSD and relevant authorities. Such a national legal framework should be consistent with the guidelines concerning supervisory practices and cooperation between authorities that ESMA may issue under this Regulation. (26) Any legal person falling within the scope of the definition of a CSD needs to be authorised by the competent national authorities before starting its activities. Taking into account different business models, a CSD should be defined by reference to certain core services, which consist of settlement, implying the operation of a securities settlement system, notary and central securities accounts maintenance services. A CSD should at least operate a securities settlement system and provide one other core service. This combination is essential for CSDs to play their role in securities settlement and in ensuring the integrity of a securities issue. Entities that do not operate securities settlement systems such as registrars, transfer agents, public authorities, bodies in charge of a registry system established under Directive 2003/87/EC, or CCPs that are regulated by Regulation (EU) No 648/2012 of the European Parliament and of the Council (10) do not fall within the scope of the definition of a CSD. (27) CSDs should have in place recovery plans to ensure continuity of their critical operations. Without prejudice to Directive 2014/59/EU of the European Parliament and of the Council (11), the competent authorities should ensure that an adequate resolution plan is established and maintained for each CSD in accordance with the relevant national law. (28) In order to provide reliable data on the scale of securities settlement outside securities settlement systems and to ensure that the risks arising can be monitored and addressed, any institutions other than CSDs that settle securities transactions outside a securities settlement system should report their settlement activities to the competent authorities concerned. The recipient competent authorities should subsequently transmit that information to ESMA and should inform ESMA of any potential risk resulting from such settlement activities. Furthermore, ESMA should monitor such settlement activities and take into account the potential risks that they might create. (29) In order to avoid any risk-taking by CSDs in activities other than those subject to authorisation under this Regulation, the activities of authorised CSDs should be limited to the provision of services covered by their authorisation or notified under this Regulation and they should not hold any participation, as defined in this Regulation by reference to the Directive 2013/34/EU of the European Parliament and of the Council (12), or any ownership, direct or indirect, of 20 % or more of the voting rights or capital in any institutions other than those providing similar services unless such a participation is approved by CSDs\u2019 competent authorities on the basis that it does not significantly increase the CSDs\u2019 risk profile. (30) In order to ensure the safe functioning of the securities settlement systems, they should be operated only by the CSDs or by central banks acting as CSDs, subject to this Regulation. (31) Without prejudice to specific requirements of Member State tax law, CSDs should be authorised to provide services ancillary to their core services that contribute to enhancing the safety, efficiency and transparency of the securities markets and that do not create undue risks to their core services. A non-exhaustive list of those services is set out in this Regulation in order to enable CSDs to respond to future market developments. Where the provision of such services relates to withholding and reporting obligations to the tax authorities, it will continue to be carried out in accordance with the law of the Member States concerned. In accordance with Article 114(2) TFEU, the power to adopt measures under Article 114(1) does not apply to fiscal provisions. In its judgement of 29 April 2004 in Case C-338/01 Commission v Council (13), the Court of Justice of the European Union held that the words \u2018fiscal provisions\u2019 are to be interpreted as \u2018covering not only the provisions determining taxable persons, taxable transactions, the basis of imposition, and rates of and exemptions from direct and indirect taxes, but also those relating to arrangements for the collection of such taxes.\u2019 This Regulation does not therefore cover arrangements for the collection of taxes for which a different legal basis would need to be used. (32) A CSD intending to outsource a core service to a third party or to provide a new core service or an ancillary service not listed in this Regulation, to operate another securities settlement system, to use another settlement agent or to set up any CSD links that involve significant risks should apply for authorisation following the same procedure as that required for initial authorisation, save that the competent authority should inform the applicant CSD within three months whether authorisation has been granted or refused. However, CSD links not involving significant risks or interoperable links of CSDs that outsource their services relating to those interoperable links to public entities, such as the members of the ESCB, should not be subject to prior authorisation, but should be notified by the relevant CSDs to their competent authorities. (33) Where a CSD intends to extend its services to non-banking type ancillary services explicitly listed in this Regulation which do not entail an increase in its risk profile, it should be able to do so following notification to the competent authority of its home Member State. (34) CSDs established in third countries should be able to offer their services in the Union, including through the setting-up of a branch. In order to ensure an appropriate level of safety in the provision of CSD services by third-country CSDs, such CSDs should be subject to recognition by ESMA where they intend to provide certain services listed in this Regulation or to set up a branch in the Union. Third-country CSDs should be able to set up links with CSDs established in the Union in the absence of such recognition provided that the relevant competent authority does not object. In view of the global nature of financial markets, ESMA is best placed to recognise third-country CSDs. ESMA should be able to recognise third-country CSDs only if the Commission concludes that they are subject to a legal and supervisory framework effectively equivalent to the one provided in this Regulation, if they are effectively authorised, supervised and subject to oversight in their country of establishment and cooperation arrangements have been established between ESMA, the competent authorities and relevant authorities of CSDs. Recognition by ESMA should be subject to an effective equivalent recognition of the prudential framework applicable to CSDs established in the Union and authorised under this Regulation. (35) Taking into account the complexity as well as the systemic nature of the CSDs and of the services they provide, transparent governance rules should ensure that senior management, members of the management body, shareholders and participants, who are in a position to exercise control, as defined by reference to the Directive 2013/34/EU, over the operation of the CSD are suitable to ensure the sound and prudent management of the CSD. (36) Different governance structures are used across Member States. In most cases a unitary or a dual board structure is used. The definitions used in this Regulation are intended to embrace all existing structures without advocating any particular structure. They are purely functional for the purpose of setting out rules aiming to achieve a particular outcome irrespective of the national company law applicable to an institution in each Member State. The definitions should therefore not interfere with the general allocation of competences in accordance with national company law. (37) Transparent governance rules should ensure that the interests of the shareholders, the management and staff of the CSD, on the one hand, and the interests of their users whom CSDs are ultimately serving, on the other, are taken into account. Those governance rules should apply without prejudice to the ownership model adopted by the CSD. User committees should be established for each securities settlement system operated by the CSD to give users the opportunity to advise the management body of the CSD on the key issues that impact them and should be given the tools to perform their role. The interests of different users of CSDs, including those of holders of different types of securities, should be represented in the user committee. (38) CSDs should be able to outsource the operation of their services provided that the risks arising from such outsourcing arrangements are managed. Taking into account the significance of the tasks entrusted to CSDs, this Regulation should provide that CSDs do not transfer their responsibilities to third parties through the outsourcing by contract of their activities to third parties. Outsourcing of such activities should be subject to strict conditions that maintain the responsibility of CSDs for their activities and ensure that the supervision and oversight of the CSDs are not impaired. It should be possible to exempt outsourcing by a CSD of its activities to a public entity from those requirements under certain conditions. (39) This Regulation should not prevent Member States allowing direct securities holding systems from providing in their national law that parties other than CSDs shall or may perform certain functions, which in some other types of securities holding systems are typically performed by CSDs and specifying how those functions should be exercised. In particular, in some Member States account operators or participants in the securities settlement systems operated by CSDs record entries into securities accounts maintained by CSDs without necessarily being account providers themselves. In view of the need for legal certainty on the entries made into accounts at the CSD level, the specific role played by such other parties should be recognised by this Regulation. It should therefore be possible, under specific circumstances and subject to strict rules laid down by law, to share the responsibility between a CSD and the relevant other party or to provide for exclusive responsibility by that other party for certain aspects related to maintaining of securities accounts at the top tier level provided that such other party is subject to appropriate regulation and supervision. There should be no restrictions on the extent to which responsibility is shared. (40) Conduct of business rules should provide transparency in the relations between CSDs and their users. In particular, CSDs should have publicly disclosed, transparent, objective and non-discriminatory criteria for participation in the securities settlement system, which would allow restriction of access by participants only on the basis of the risks involved. A quick and appropriate remedy should be made available to competent authorities to address any unjustified refusal of CSDs to provide their services to participants. CSDs should publicly disclose prices and fees for their services. In order to provide open and non-discriminatory access to their services and in view of the significant market power that CSDs still enjoy in the territory of their respective Member States, CSDs should not be able to diverge from their published pricing policy for their core services and should maintain separate accounts for the costs and revenues associated with each of their core services and with their ancillary services. Those participation provisions complement and reinforce the right of market participants to use a settlement system in another Member State provided for in Directive 2014/65/EU. (41) In order to facilitate efficient recording, settlement and payment, CSDs should accommodate in their communication procedures with participants and with the market infrastructures they interface with, the relevant international open communication procedures and standards for messaging and reference data. (42) Taking into account the central role of securities settlement systems in the financial markets, CSDs should, when providing their services, make best efforts to ensure the timely settlement of securities transactions and the integrity of the securities issue. This Regulation should not interfere with the national law of the Member States regulating the holdings of securities and the arrangements maintaining the integrity of securities issues. However, in order to enhance the protection of the assets of their participants and those of their clients, this Regulation should require CSDs to segregate the securities accounts maintained for each participant and offer, upon request, further segregation of the accounts of the participants\u2019 clients which in some cases might be available only at a higher cost to be borne by the participants\u2019 clients requesting further segregation. CSDs and their participants should be required to provide for both omnibus client segregation and individual client segregation so clients can choose the level of segregation they believe is appropriate to their needs. The only exclusion from this should be where due to other public policy requirements, in particular in relation to efficient and transparent collection of taxation, a CSD and its participants are required to provide individual client segregation for citizens and residents of and legal persons established in a Member State where, at the date of entry into force of this Regulation, such individual client segregation is required under the national law of the Member State under which the securities are constituted and only for citizens, residents of and legal persons established in that Member State. CSDs should ensure that those requirements apply separately to each securities settlement system operated by them. Without prejudice to the provision of ancillary services, CSDs should not use on their own account any securities that belong to a participant unless explicitly authorised by that participant and should not otherwise use on their own account the securities that do not belong to them. In addition the CSD should require the participants to obtain any necessary prior consent from their clients. (43) Directive 98/26/EC provides that transfer orders entered into securities settlement systems in accordance with the rules of those systems should be legally enforceable and binding on third parties. However, since Directive 98/26/EC does not specifically refer to CSDs that operate securities settlement systems, for clarity, this Regulation should require CSDs to define the moment or moments when transfer orders are entered into their systems and become irrevocable in accordance with the rules of that Directive. In addition, in order to increase legal certainty, CSDs should disclose to their participants the moment when the transfer of securities and cash in a securities settlement system is legally enforceable and binding on third parties in accordance, as the case may be, with national law. CSDs should also take all reasonable steps to ensure that transfers of securities and cash are legally enforceable and binding on third parties no later than at the end of the business day of the actual settlement date. (44) In order to avoid settlement risks due to the insolvency of the settlement agent, a CSD should settle, whenever practical and available, the cash leg of the securities transaction through accounts opened with a central bank. If this option is not practical and available, a CSD should be able to settle through accounts opened with a credit institution established under the conditions provided in Directive 2013/36/EU of the European Parliament and of the Council (14) and subject to a specific authorisation procedure and prudential requirements provided in Title IV of this Regulation. (45) Banking services ancillary to settlement involving credit and liquidity risks should only be undertaken by CSDs or outsourced to entities authorised to provide the banking services ancillary to the CSD activities as laid down in this Regulation. (46) In order to secure efficiencies resulting from the provision of both CSD and banking services within the same group of undertakings, the requirements of this Regulation should not prevent credit institutions from belonging to the same group of undertakings as the CSD. It is appropriate to provide for arrangements under which CSDs could be authorised to provide to their participants and to other entities ancillary services from within the same legal entity or from within a separate legal entity which may be part of the same group of undertakings ultimately controlled by the same parent undertaking or not. Where a credit institution other than a central bank acts as a settlement agent, the credit institution should be able to provide to the CSD participants the services set out in this Regulation, which are covered by the authorisation, but should not provide other banking services from the same legal entity in order to limit the settlement system\u2019s exposure to the risks resulting from the failure of the credit institution. (47) Since Directive 2013/36/EU does not specifically address intra-day credit and liquidity risks resulting from the provision of banking services ancillary to settlement, credit institutions and CSDs providing such services should also be subject to specific enhanced credit and liquidity risk mitigation requirements, including a risk-based capital surcharge which reflects the relevant risks. Such enhanced credit and liquidity risk mitigation requirements should follow the global standards for financial market infrastructures and the principles for \u2018Monitoring tools for intra-day liquidity management\u2019 published in April 2013 by the Basel Committee on Banking Supervision. (48) Some CSDs also operating as credit institutions are subject to own funds and reporting requirements relevant for credit institutions and laid down in Regulation (EU) No 575/2013 of the European Parliament and of the Council (15) and in Directive 2013/36/EU. Given the systemic importance of such CSDs it is appropriate that the strictest requirements provided in Union law apply in order to avoid the cumulative application of various Union rules, for example in relation to the reporting of own funds requirements. In any areas where potential duplication of requirements is identified, the European Supervisory Authority (European Banking Authority) (\u2018EBA\u2019) established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council (16) and ESMA should provide an opinion on the appropriate application of the Union acts in accordance with Article 34 of Regulation (EU) No 1093/2010 and of Regulation (EU) No 1095/2010. (49) In addition to the own funds requirements provided for in Regulation (EU) No 575/2013 and in Directive 2013/36/EU, credit institutions and CSDs should be subject to a capital surcharge that reflects the risks, such as credit and liquidity risks, resulting from the provision of intra-day credit, inter alia, to the participants in a securities settlement system or other users of CSD services. (50) In order to ensure full compliance with specific measures aimed at mitigating credit and liquidity risks, the competent authorities should be able to require CSDs to designate more than one credit institution whenever they can demonstrate, based on the available evidence, that the exposures of one credit institution to the concentration of credit and liquidity risks is not fully mitigated. CSDs should also be able to designate more than one credit institution. (51) Supervision of the compliance of designated credit institutions or CSDs authorised to provide banking services ancillary to settlement with the requirements of Regulation (EU) No 575/2013 and of Directive 2013/36/EU and the specific relevant prudential requirements of this Regulation should be entrusted to the competent authorities referred to in Regulation (EU) No 575/2013. In order to ensure consistent application of supervisory standards, it is desirable that the banking services of CSDs which are of a scale and nature to pose a significant risk to the financial stability of the Union are directly supervised by the ECB under the conditions provided for in Council Regulation (EU) No 1024/2013 (17) concerning policies relating to the prudential supervision of credit institutions. This Regulation should be without prejudice to Regulation (EU) No 1024/2013. (52) A credit institution or a CSD authorised to provide banking services ancillary to settlement should comply with any present or future Union legislation applicable to credit institutions. This Regulation should be without prejudice to Directive 2014/59/EU and any future Union legislative act regarding the framework for the recovery and resolution of credit institutions, investment firms and other financial institutions. (53) In order to provide a sufficient degree of safety and continuity of services provided by CSDs, CSDs should be subject to specific uniform and directly applicable prudential and capital requirements which mitigate their legal, operational and investment risks. (54) The safety of the link arrangements set up between CSDs should be subject to specific requirements to enable the access of their respective participants to other securities settlement systems. The provision of banking-type ancillary services from within a separate legal entity should not prevent CSDs from receiving such services, in particular when they are participants in a securities settlement system operated by another CSD. It is particularly important that any potential risks resulting from the link arrangements such as credit, liquidity, organisational or any other relevant risks for CSDs are fully mitigated. For interoperable links, it is important that linked securities settlement systems have identical moments of entry of transfer orders into the system and irrevocability of such transfer orders and use equivalent rules concerning the moment of finality of transfers of securities and cash. The same principles should apply to CSDs that use a common settlement information technology (IT) infrastructure. (55) In order to allow competent authorities to supervise the activities of CSDs effectively, CSDs should be subject to strict record-keeping requirements. CSDs should maintain for at least 10 years all the records and data on all the services that they may provide, including transaction data on collateral management services that involve the processing of securities repurchase or lending agreements. CSDs might need to specify a common format in which their clients provide transaction data so as to allow this record-keeping requirement to be met, in conformity with any relevant regulatory and implementing technical standards adopted under this Regulation. (56) In many Member States issuers are required by national law to issue certain types of securities, notably shares, within their national CSDs. In order to remove this barrier to the smooth functioning of the Union post-trading market and to allow issuers to opt for the most efficient way of managing their securities, issuers should have the right to choose any CSD established in the Union for recording their securities and receiving any relevant CSD services. Since harmonisation of national corporate law is beyond the scope of this Regulation, such national corporate or similar law under which the securities are constituted should continue to apply and arrangements be made to ensure that the requirements of such national corporate or similar law can be met where the right of choice of CSD is exercised. Such national corporate and similar law under which the securities are constituted govern the relationship between their issuer and holders or any third parties, and their respective rights and duties attached to the securities such as voting rights, dividends and corporate actions. A refusal to provide services to an issuer should be permissible only based on a comprehensive risk assessment or if that CSD does not provide any issuance services in relation to securities constituted under the corporate or similar law of the relevant Member State. A quick and appropriate remedy should be made available to competent authorities to address any unjustified refusal of CSDs to provide their services to issuers. (57) In view of the increasing cross-border holdings and transfers of securities enhanced by this Regulation, it is of the utmost urgency and importance to establish clear rules on the law applicable to proprietary aspects in relation to the securities held in the accounts maintained by CSDs. Nevertheless, this is a horizontal issue which goes beyond the scope of this Regulation and could be dealt with in future Union legislative acts. (58) The European Code of Conduct for Clearing and Settlement of 7 November 2006 created a voluntary framework to enable access between CSDs and other market infrastructures. However, the post-trade sector remains fragmented along national lines, making cross-border trade unnecessarily costly. It is necessary to lay down uniform conditions for links between CSDs and of access between CSDs and other market infrastructures. In order to enable CSDs to offer their participants access to other markets, they should have a right to become a participant in another CSD or request another CSD to develop special functions for having access to the latter. Such access should be granted on fair, reasonable and non-discriminatory terms and should be refused only where it threatens the smooth and orderly functioning of the financial markets or causes systemic risk. A quick and appropriate remedy should be made available to competent authorities to address any unjustified refusal of a CSD to grant access to another CSD. Where CSD links introduce significant risks for settlement, they should be subject to authorisation and increased supervision by the relevant competent authorities. (59) CSDs should also have access to transaction feeds from a CCP or a trading venue and those market infrastructures should have access to the securities settlement systems operated by CSDs. Such access may be refused only where it threatens the smooth and orderly functioning of the financial markets or causes systemic risk and may not be denied on the grounds of loss of market share. (60) A quick and appropriate remedy should be made available to competent authorities to address any unjustified refusal of CSDs or market infrastructures to provide access to their services. This Regulation completes the access arrangements between trading venues, CCPs, and CSDs as laid down in Regulation (EU) No 648/2012 and in Regulation (EU) No 600/2014 necessary to establish a competitive internal market in post-trade services. ESMA and the Commission should continue to monitor closely the evolution of post-trade infrastructure and the Commission should, where necessary, intervene in order to prevent competitive distortions from occurring in the internal market. (61) A sound prudential and conduct of business framework for the financial sector should rest on strong supervisory and sanctioning regimes. To that end, supervisory authorities should be equipped with sufficient powers to act and should be able to rely on deterrent sanctioning regimes to be used against any unlawful conduct. A review of existing sanctioning powers and their practical application aiming to promote convergence of sanctions across the range of supervisory activities has been carried out in the Commission Communication of 8 December 2010 entitled \u2018Reinforcing sanctioning regimes in the financial services sector\u2019. (62) Therefore, in order to ensure effective compliance by CSDs, credit institutions designated as settlement agents, the members of their management bodies and any other persons who effectively control their business or any other persons with the requirements of this Regulation, competent authorities should be able to apply administrative sanctions and other measures which are effective, proportionate and dissuasive. (63) In order to provide deterrence and consistent application of the sanctions across Member States, this Regulation should provide a list of key administrative sanctions and other measures that need to be available to the competent authorities, for the power to impose those sanctions and other measures on all persons, whether legal or natural, responsible for an infringement, for a list of key criteria when determining the level and type of those sanctions and other measures and for levels of administrative pecuniary sanctions. Administrative fines should take into account factors such as any identified financial benefit resulting from the infringement, the gravity and duration of the infringement, any aggravating or mitigating factors, the need for administrative fines to have a deterrent effect and, where appropriate, include a discount for cooperation with the competent authority. The adoption and publication of sanctions should respect fundamental rights as laid down in the Charter of Fundamental Rights of the European Union (\u2018the Charter\u2019), in particular the rights to respect for private and family life (Article 7), the right to the protection of personal data (Article 8) and the right to an effective remedy and to a fair trial (Article 47). (64) In order to detect potential infringements, effective mechanisms to encourage reporting of potential or actual infringements of this Regulation to the competent authorities should be put in place. Those mechanisms should include adequate safeguards for the persons who report potential or actual infringements of this Regulation and the persons accused of such infringements. Appropriate procedures should be established to comply with the accused person\u2019s right to protection of personal data, with the right of defence and to be heard before the adoption of a final decision affecting that person as well as with the right to seek effective remedy before a tribunal against any decision or measure affecting that person. (65) This Regulation should be without prejudice to any provisions in the law of Member States relating to criminal sanctions. (66) Directive 95/46/EC of the European Parliament and of the Council (18) governs the processing of personal data carried out in the Member States pursuant to this Regulation. Any exchange or transmission of personal data by competent authorities of the Member States should be undertaken in accordance with the rules on the transfer of personal data as laid down in Directive 95/46/EC. Regulation (EC) No 45/2001 of the European Parliament and of the Council (19) governs the processing of personal data carried out by ESMA pursuant to this Regulation. Any exchange or transmission of personal data carried out by ESMA should be in accordance with the rules on the transfer of personal data as laid down in Regulation (EC) No 45/2001. (67) This Regulation complies with the fundamental rights and observes the principles recognised in particular by the Charter, notably the rights to respect for private and family life, the right to the protection of personal data, the right to an effective remedy and to a fair trial, the right not to be tried or punished twice for the same offence, and the freedom to conduct a business, and has to be applied in accordance with those rights and principles. (68) ESMA should play a central role in the application of this Regulation by ensuring consistent application of Union rules by national competent authorities and by settling disagreements between them. (69) ESMA should submit annual reports to the Commission assessing the trends and potential risks in the markets covered by this Regulation. Those reports should include at least an assessment of settlement efficiency, internalised settlement, cross-border provision of services, the reasons for the rejection of access rights and any other substantive barriers to competition in post-trade financial services including any barriers arising from the inappropriate use of licensing arrangements, appropriateness of penalties for settlement fails, in particular the need for additional flexibility in relation to penalties for settlement fails in relation to illiquid financial instruments, the application of Member States\u2019 rules on civil liability to losses attributable to CSDs, the conditions relating to the provision of banking-type ancillary services, requirements regarding the protection of securities of participants and those of their clients, and the sanctions regime and may contain, where necessary, recommendations of preventative or remedial actions. ESMA should also conduct peer reviews covering the activities of the competent authorities under this Regulation within an appropriate time-frame and in accordance with Regulation (EU) No 1095/2010. Given the systemic importance of CSDs and the fact that they are being regulated for the first time at Union level, it is appropriate to require that such peer reviews should initially occur every three years at least in relation to the supervision of CSDs which make use of the freedom to provide services or participate in an interoperable link. (70) As a body with highly specialised expertise regarding securities and securities markets, it is efficient and appropriate to entrust ESMA with the development of draft regulatory and implementing technical standards which do not involve policy choices, for submission to the Commission. Where specified, ESMA should also closely cooperate with the members of the ESCB and EBA. (71) The Commission should be empowered to adopt regulatory technical standards in accordance with Article 290 TFEU and with Articles 10 to 14 of Regulation (EU) No 1093/2010 and of Regulation (EU) No 1095/2010 with regard to the detailed elements of the settlement discipline measures; the reporting of internalised settlement; information and other elements to be included by a CSD in its application for authorisation; conditions under which the competent authorities of CSDs may approve their participations in the capital of certain legal entities, the information that different authorities shall supply each other when supervising CSDs; the information that the applicant CSD shall provide ESMA in its application for recognition; the elements of the governance arrangements for CSDs; the details of the records to be kept by CSDs; the risks to be taken into account by CSDs when carrying out a comprehensive risk assessment, and competent authorities assessing the reasons for refusal of requests for access; the elements of the procedure for access of participants and issuers to CSDs, access between CSDs and between CSDs and other market infrastructures; the details of the measures to be taken by CSDs so that the integrity of the issue is maintained; the mitigation of the operational and investment risks and of the risks derived from the CSD links; the details of the capital requirements for CSDs; the details of the application for authorisation to provide banking-type ancillary services; the capital surcharge and the prudential requirements on credit and liquidity risks for CSDs and designated credit institutions that are authorised to provide banking-type ancillary services. (72) The Commission should also be empowered to adopt implementing technical standards by means of implementing acts pursuant to Article 291 TFEU and in accordance with Article 15 of Regulation (EU) No 1095/2010 with regard to standard forms and templates for reporting on internalised settlement; for the application for authorisation by CSDs; for the provision of information between different competent authorities for the purposes of supervision of CSDs; for the relevant cooperation arrangements between authorities of home and host Member States; for formats of records to be kept by CSDs; for the procedures in cases where a participant or an issuer is denied access to a CSD, CSDs are denied access between themselves or between CSDs and other market infrastructures; and for the consultation of different authorities prior to granting authorisation to a settlement agent. (73) In order to attain the objectives set out in this Regulation, the power to adopt acts in accordance with Article 290 of the TFEU should be delegated to the Commission in respect of specific details concerning some definitions, parameters for the calculation of cash penalties for the participants that cause settlement fails, the criteria under which the operations of a CSD in a host Member State should be considered to be of substantial importance for that Member State. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (74) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to take decisions on the assessment of rules from third countries for the purposes of recognition of third-country CSDs. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (20). (75) When assessing the relevant rules of third countries, a proportionate, outcomes-based approach should be taken, focusing on compliance with applicable Union rules and, where relevant, international standards. Conditional or interim recognition may also be granted where there are no areas of substantive difference that would have foreseeable detrimental effects on Union markets. (76) Since the objectives of this Regulation, namely to lay down uniform requirements for settlement as well as for CSDs, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (77) It is necessary to amend Directive 98/26/EC to bring it in line with the Directive 2010/78/EU of the European Parliament and of the Council (21), whereby designated securities settlement systems are no longer notified to the Commission but to ESMA. (78) Taking into account the fact that this Regulation harmonises at Union level the measures to prevent and address settlement fails and has a wider scope of application for such measures than Regulation (EU) No 236/2012 of the European Parliament and of the Council (22), it is necessary to repeal Article 15 of that Regulation. (79) CSDs should be exempt from the application of Directive 2014/65/EU and Regulation (EU) No 600/2014 where they provide services that are explicitly listed in this Regulation. However, in order to ensure that any entities providing investment services and activities are subject to Directive 2014/65/EU and Regulation (EU) No 600/2014 and to avoid competitive distortions between different types of providers of such services, it is necessary to require CSDs that provide investment services and activities in the course of their ancillary services to be subject to the requirements of Directive 2014/65/EU and Regulation (EU) No 600/2014. (80) The application of the authorisation and recognition requirements of this Regulation should be deferred in order to provide CSDs established in the Union or in third countries with sufficient time to apply for authorisation and recognition of their activities provided for in this Regulation. Until a decision is made under this Regulation on the authorisation or recognition of CSDs and of their activities, including CSD links, the respective national rules on authorisation and recognition of CSDs should continue to apply. (81) It is also necessary to defer the application of the requirements concerning settlement discipline and requirements concerning reporting obligation of settlement internalisers until all the necessary delegated or implementing acts further specifying such requirements are in place, and of the requirements for recording certain transferable securities in book-entry form and settling obligations in securities settlement systems no later than on the second business day after the trading in order to provide market participants, holding securities in paper form or using longer settlement periods, with sufficient time to comply with those requirements, HAVE ADOPTED THIS REGULATION: TITLE I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter and scope 1. This Regulation lays down uniform requirements for the settlement of financial instruments in the Union and rules on the organisation and conduct of central securities depositories (CSDs) to promote safe, efficient and smooth settlement. 2. This Regulation applies to the settlement of all financial instruments and activities of CSDs unless otherwise specified in this Regulation. 3. This Regulation is without prejudice to provisions of Union law concerning specific financial instruments, in particular Directive 2003/87/EC. 4. Articles 10 to 20, 22 to 24 and 27, Article 28(6), Article 30(4) and Articles 46 and 47, the provisions of Title IV and the requirements to report to competent authorities or relevant authorities or to comply with their orders under this Regulation, do not apply to the members of the ESCB, other Member States\u2019 national bodies performing similar functions, or to other public bodies charged with or intervening in the management of public debt in the Union in relation to any CSD which the aforementioned bodies directly manage under the responsibility of the same management body, which has access to the funds of those bodies and which is not a separate entity. Article 2 Definitions 1. For the purposes of this Regulation, the following definitions apply: (1) \u2018central securities depository\u2019 or \u2018CSD\u2019 means a legal person that operates a securities settlement system referred to in point (3) of Section A of the Annex and provides at least one other core service listed in Section A of the Annex; (2) \u2018third-country CSD\u2019 means any legal entity established in a third country that provides a similar service to the core service referred to in point (3) of Section A of the Annex and performs at least one other core service listed in Section A of the Annex; (3) \u2018immobilisation\u2019 means the act of concentrating the location of physical securities in a CSD in a way that enables subsequent transfers to be made by book entry; (4) \u2018dematerialised form\u2019 means the fact that financial instruments exist only as book entry records; (5) \u2018receiving CSD\u2019 means the CSD which receives the request of another CSD to have access to its services through a CSD link; (6) \u2018requesting CSD\u2019 means the CSD which requests access to the services of another CSD through a CSD link; (7) \u2018settlement\u2019 means the completion of a securities transaction where it is concluded with the aim of discharging the obligations of the parties to that transaction through the transfer of cash or securities, or both; (8) \u2018financial instruments\u2019 or \u2018securities\u2019 means financial instruments as defined in point (15) of Article 4(1) of Directive 2014/65/EU; (9) \u2018transfer order\u2019 means transfer order as defined in the second indent of point (i) of Article 2 of Directive 98/26/EC; (10) \u2018securities settlement system\u2019 means a system under the first, second and third indents of point (a) of Article 2 of Directive 98/26/EC that is not operated by a central counterparty whose activity consists of the execution of transfer orders; (11) \u2018settlement internaliser\u2019 means any institution, including one authorised in accordance with Directive 2013/36/EU or with Directive 2014/65/EU, which executes transfer orders on behalf of clients or on its own account other than through a securities settlement system; (12) \u2018intended settlement date\u2019 means the date that is entered into the securities settlement system as the settlement date and on which the parties to a securities transaction agree that settlement is to take place; (13) \u2018settlement period\u2019 means the time period between the trade date and the intended settlement date; (14) \u2018business day\u2019 means business day as defined in point (n) of Article 2 of Directive 98/26/EC; (15) \u2018settlement fail\u2019 means the non-occurrence of settlement, or partial settlement of a securities transaction on the intended settlement date, due to a lack of securities or cash and regardless of the underlying cause; (16) \u2018central counterparty\u2019 or \u2018CCP\u2019 means a CCP as defined in point (1) of Article 2 of Regulation (EU) No 648/2012; (17) \u2018competent authority\u2019 means the authority designated by each Member State in accordance with Article 11, unless otherwise specified in this Regulation; (18) \u2018relevant authority\u2019 means any authority referred to in Article 12; (19) \u2018participant\u2019 means any participant, as defined in point (f) of Article 2 of Directive 98/26/EC in a securities settlement system; (20) \u2018participation\u2019 means participation within the meaning of the first sentence of point (2) of Article 2 of Directive 2013/34/EU, or the ownership, direct or indirect, of 20 % or more of the voting rights or capital of an undertaking; (21) \u2018control\u2019 means the relationship between two undertakings as described in Article 22 of Directive 2013/34/EU; (22) \u2018subsidiary\u2019 means a subsidiary undertaking within the meaning of Article 2(10) and Article 22 of Directive 2013/34/EU; (23) \u2018home Member State\u2019 means the Member State in which a CSD is established; (24) \u2018host Member State\u2019 means the Member State, other than the home Member State, in which a CSD has a branch or provides CSD services; (25) \u2018branch\u2019 means a place of business other than the head office which is a part of a CSD, which has no legal personality and which provides CSD services for which the CSD has been authorised; (26) \u2018default\u2019, in relation to a participant, means a situation where insolvency proceedings, as defined in point (j) of Article 2 of Directive 98/26/EC, are opened against a participant; (27) \u2018delivery versus payment\u2019 or \u2018DVP\u2019 means a securities settlement mechanism which links a transfer of securities with a transfer of cash in a way that the delivery of securities occurs if and only if the corresponding transfer of cash occurs and vice versa; (28) \u2018securities account\u2019 means an account on which securities may be credited or debited; (29) \u2018CSD link\u2019 means an arrangement between CSDs whereby one CSD becomes a participant in the securities settlement system of another CSD in order to facilitate the transfer of securities from the participants of the latter CSD to the participants of the former CSD or an arrangement whereby a CSD accesses another CSD indirectly via an intermediary. CSD links include standard links, customised links, indirect links, and interoperable links; (30) \u2018standard link\u2019 means a CSD link whereby a CSD becomes a participant in the securities settlement system of another CSD under the same terms and conditions as applicable to any other participant in the securities settlement system operated by the latter; (31) \u2018customised link\u2019 means a CSD link whereby a CSD that becomes a participant in the securities settlement system of another CSD is provided with additional specific services to the services normally provided by that CSD to participants in the securities settlement system; (32) \u2018indirect link\u2019 means an arrangement between a CSD and a third party other than a CSD, that is a participant in the securities settlement system of another CSD. Such link is set up by a CSD in order to facilitate the transfer of securities to its participants from the participants of another CSD; (33) \u2018interoperable link\u2019 means a CSD link whereby CSDs agree to establish mutual technical solutions for settlement in the securities settlement systems that they operate; (34) \u2018international open communication procedures and standards\u2019 means internationally accepted standards for communication procedures, such as standardised messaging formats and data representation, which are available on a fair, open and non-discriminatory basis to any interested party; (35) \u2018transferable securities\u2019 means transferable securities as defined in point (44) of Article 4(1) of Directive 2014/65/EU; (36) \u2018shares\u2019 means securities specified in point (44)(a) of Article 4(1) of Directive 2014/65/EU; (37) \u2018money-market instruments\u2019 means money-market instruments as defined in point (17) of Article 4(1) of Directive 2014/65/EU; (38) \u2018units in collective investment undertakings\u2019 means units in collective investment undertakings as referred to in point (3) of Section C of Annex I to Directive 2014/65/EU; (39) \u2018emission allowance\u2019 means emission allowance as described in point (11) of Section C of Annex I to Directive 2014/65/EU, excluding derivatives in emission allowances; (40) \u2018regulated market\u2019 means regulated market as defined in point (21) of Article 4(1) of Directive 2014/65/EU; (41) \u2018multilateral trading facility\u2019 or \u2018MTF\u2019 means multilateral trading facility as defined in point (22) of Article 4(1) of Directive 2014/65/EU; (42) \u2018trading venue\u2019 means a trading venue as defined in point (24) of Article 4(1) of Directive 2014/65/EU; (43) \u2018settlement agent\u2019 means settlement agent as defined in point (d) of Article 2 of Directive 98/26/EC; (44) \u2018SME growth market\u2019 means an SME growth market as defined in point (12) of Article 4(1) of Directive 2014/65/EU; (45) \u2018management body\u2019 means the body or bodies of a CSD, appointed in accordance with national law, which is empowered to set the CSD\u2019s strategy, objectives and overall direction, and which oversees and monitors management decision-making and includes persons who effectively direct the business of the CSD. Where, according to national law, a management body comprises different bodies with specific functions, the requirements of this Regulation shall apply only to members of the management body to whom the applicable national law assigns the respective responsibility; (46) \u2018senior management\u2019 means those natural persons who exercise executive functions within a CSD and who are responsible and accountable to the management body for the day-to-day management of that CSD. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 67 concerning measures to further specify the non-banking-type ancillary services set out in points (1) to (4) of Section B of the Annex and the banking-type ancillary services set out in Section C of the Annex. TITLE II SECURITIES SETTLEMENT CHAPTER I Book-entry form Article 3 Book-entry form 1. Without prejudice to paragraph 2, any issuer established in the Union that issues or has issued transferable securities which are admitted to trading or traded on trading venues, shall arrange for such securities to be represented in book-entry form as immobilisation or subsequent to a direct issuance in dematerialised form. 2. Where a transaction in transferable securities takes place on a trading venue the relevant securities shall be recorded in book-entry form in a CSD on or before the intended settlement date, unless they have already been so recorded. Where transferable securities are transferred following a financial collateral arrangement as defined in point (a) of Article 2(1) of Directive 2002/47/EC, those securities shall be recorded in book-entry form in a CSD on or before the intended settlement date, unless they have already been so recorded. Article 4 Enforcement 1. The authorities of the Member State where the issuer that issues securities is established shall ensure that Article 3(1) is applied. 2. The authorities competent for the supervision of the trading venues, including the competent authorities designated in accordance with Article 21(1) of Directive 2003/71/EC of the European Parliament and of the Council (23), shall ensure that the first subparagraph of Article 3(2) of this Regulation is applied where the securities referred to in Article 3(1) of this Regulation are traded on trading venues. 3. Member States\u2019 authorities responsible for the application of Directive 2002/47/EC shall ensure that the second subparagraph of Article 3(2) of this Regulation is applied where the securities referred to in Article 3(1) of this Regulation are transferred following a financial collateral arrangement as defined in point (a) of Article 2(1) of Directive 2002/47/EC. CHAPTER II Settlement periods Article 5 Intended settlement date 1. Any participant in a securities settlement system that settles in that system on its own account or on behalf of a third party transactions in transferable securities, money-market instruments, units in collective investment undertakings and emission allowances shall settle such transactions on the intended settlement date. 2. As regards transactions in transferable securities referred to in paragraph 1 which are executed on trading venues, the intended settlement date shall be no later than on the second business day after the trading takes place. That requirement shall not apply to transactions which are negotiated privately but executed on a trading venue, to transactions which are executed bilaterally but reported to a trading venue or to the first transaction where the transferable securities concerned are subject to initial recording in book-entry form pursuant to Article 3(2). 3. The competent authorities shall ensure that paragraph 1 is applied. The authorities competent for the supervision of trading venues shall ensure that paragraph 2 is applied. CHAPTER III Settlement discipline Article 6 Measures to prevent settlement fails 1. Trading venues shall establish procedures that enable the confirmation of relevant details of transactions in financial instruments referred to in Article 5(1) on the date when the transaction has been executed. 2. Notwithstanding the requirement laid down in paragraph 1, investment firms authorised pursuant to Article 5 of Directive 2014/65/EU shall, where applicable, take measures to limit the number of settlement fails. Such measures shall at least consist of arrangements between the investment firm and its professional clients as referred to in Annex II to Directive 2014/65/EU to ensure the prompt communication of an allocation of securities to the transaction, confirmation of that allocation and confirmation of the acceptance or rejection of terms in good time before the intended settlement date. ESMA shall, in close cooperation with the members of the ESCB, issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 on the standardised procedures and messaging protocols to be used for complying with the second subparagraph of this paragraph. 3. For each securities settlement system it operates, a CSD shall establish procedures that facilitate the settlement of transactions in financial instruments referred to in Article 5(1) on the intended settlement date with a minimum exposure of its participants to counterparty and liquidity risks and a low rate of settlement fails. It shall promote early settlement on the intended settlement date through appropriate mechanisms. 4. For each securities settlement system it operates, a CSD shall put in place measures to encourage and incentivise the timely settlement of transactions by its participants. CSDs shall require participants to settle their transactions on the intended settlement date. 5. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the measures to be taken by investment firms in accordance with the first subparagraph of paragraph 2, the details of the procedures facilitating settlement referred to in paragraph 3 and the details of the measures to encourage and incentivise the timely settlement of transactions referred to in paragraph 4. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 7 Measures to address settlement fails 1. For each securities settlement system it operates, a CSD shall establish a system that monitors settlement fails of transactions in financial instruments referred to in Article 5(1). It shall provide regular reports to the competent authority and relevant authorities, as to the number and details of settlement fails and any other relevant information, including the measures envisaged by CSDs and their participants to improve settlement efficiency. Those reports shall be made public by CSDs in an aggregated and anonymised form on an annual basis. The competent authorities shall share with ESMA any relevant information on settlement fails. 2. For each securities settlement system it operates, a CSD shall establish procedures that facilitate settlement of transactions in financial instruments referred to in Article 5(1) that are not settled on the intended settlement date. These procedures shall provide for a penalty mechanism which will serve as an effective deterrent for participants that cause settlement fails. Before establishing the procedures referred to in the first subparagraph, a CSD shall consult the relevant trading venues and CCPs in respect of which it provides settlement services. The penalty mechanism referred to in the first subparagraph shall include cash penalties for participants that cause settlement fails (\u2018failing participants\u2019). Cash penalties shall be calculated on a daily basis for each business day that a transaction fails to be settled after its intended settlement date until the end of a buy-in process referred to in paragraph 3, but no longer than the actual settlement day. The cash penalties shall not be configured as a revenue source for the CSD. 3. Without prejudice to the penalty mechanism referred to in paragraph 2 and the right to bilaterally cancel the transaction, where a failing participant does not deliver the financial instruments referred to in Article 5(1) to the receiving participant within 4 business days after the intended settlement date (\u2018extension period\u2019) a buy-in process shall be initiated whereby those instruments shall be available for settlement and delivered to the receiving participant within an appropriate time-frame. Where the transaction relates to a financial instrument traded on an SME growth market the extension period shall be 15 days unless the SME growth market decides to apply a shorter period. 4. The following exemptions from the requirement referred to in paragraph 3 shall apply: (a) based on asset type and liquidity of the financial instruments concerned, the extension period may be increased from four business days up to a maximum of seven business days where a shorter extension period would affect the smooth and orderly functioning of the financial markets concerned; (b) for operations composed of several transactions including securities repurchase or lending agreements, the buy-in process referred to in paragraph 3 shall not apply where the timeframe of those operations is sufficiently short and renders the buy-in process ineffective. 5. Without prejudice to paragraph 7, the exemptions referred to in paragraph 4 shall not apply in relation to transactions for shares where those transactions are cleared by a CCP. 6. Without prejudice to the penalty mechanism referred to in paragraph 2, where the price of the shares agreed at the time of the trade is higher than the price paid for the execution of the buy-in, the corresponding difference shall be paid to the receiving participant by the failing participant no later than on the second business day after the financial instruments have been delivered following the buy-in. 7. If the buy-in fails or is not possible, the receiving participant can choose to be paid cash compensation or to defer the execution of the buy-in to an appropriate later date (\u2018deferral period\u2019). If the relevant financial instruments are not delivered to the receiving participant at the end of the deferral period, cash compensation shall be paid. Cash compensation shall be paid to the receiving participant no later than on the second business day after the end of either the buy-in process referred to in paragraph 3 or the deferral period, where the deferral period was chosen. 8. The failing participant shall reimburse the entity that executes the buy-in for all amounts paid in accordance with paragraphs 3, 4 and 5, including any execution fees resulting from the buy-in. Such fees shall be clearly disclosed to the participants. 9. CSDs, CCPs and trading venues shall establish procedures that enable them to suspend in consultation with their respective competent authorities, any participant that fails consistently and systematically to deliver the financial instruments referred to in Article 5(1) on the intended settlement date and to disclose to the public its identity only after giving that participant the opportunity to submit its observations and provided that the competent authorities of the CSDs, CCPs and trading venues, and of that participant have been duly informed. In addition to consulting before any suspension, CSDs, CCPs and trading venues shall notify, without delay, the respective competent authorities of the suspension of a participant. The competent authority shall immediately inform the relevant authorities of the suspension of a participant. Public disclosure of suspensions shall not contain personal data within the meaning of point (a) of Article 2 of Directive 95/46/EC. 10. Paragraphs 2 to 9 shall apply to all transactions of the financial instruments referred to in Article 5(1) which are admitted to trading or traded on a trading venue or cleared by a CCP as follows: (a) for transactions cleared by a CCP, the CCP shall be the entity that executes the buy-in according to paragraphs 3 to 8; (b) for transactions not cleared by a CCP but executed on a trading venue, the trading venue shall include in its internal rules an obligation for its members and its participants to apply the measures referred to in paragraphs 3 to 8; (c) for all transactions other than those referred to in points (a) and (b) of this subparagraph, CSDs shall include in their internal rules an obligation for their participants to be subject to the measures referred to in paragraphs 3 to 8. A CSD shall provide the necessary settlement information to CCPs and trading venues to enable them to fulfil their obligations under this paragraph. Without prejudice to points (a), (b) and (c) of the first subparagraph, CSDs may monitor the execution of buy-ins referred to in those points with respect to multiple settlement instructions, on the same financial instruments and with the same date of expiry of the execution period, with the aim of minimising the number of buy-ins to be executed and thus the impact on the prices of the relevant financial instruments. 11. Paragraphs 2 to 9 shall not apply to failing participants which are CCPs. 12. Paragraphs 2 to 9 shall not apply if insolvency proceedings are opened against the failing participant. 13. This Article shall not apply where the principal venue for the trading of shares is located in a third country. The location of the principal venue for the trading of shares shall be determined in accordance with Article 16 of Regulation (EU) No 236/2012. 14. The Commission shall be empowered to adopt delegated acts in accordance with Article 67 to specify parameters for the calculation of a deterrent and proportionate level of the cash penalties referred to in the third subparagraph of paragraph 2 based on asset type and liquidity of the financial instrument and type of transaction that shall ensure a high degree of settlement discipline and the smooth and orderly functioning of the financial markets concerned. 15. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify: (a) the details of the system monitoring settlement fails and the reports on settlement fails referred to in paragraph 1; (b) the processes for collection and redistribution of cash penalties and any other possible proceeds from such penalties in accordance with paragraph 2; (c) the details of operation of the appropriate buy-in process referred to in paragraphs 3 to 8, including appropriate time-frames to deliver the financial instrument following the buy-in process referred to in paragraph 3. Such time-frames shall be calibrated taking into account the asset type and liquidity of the financial instruments; (d) the circumstances under which the extension period could be prolonged according to asset type and liquidity of the financial instruments, in accordance with the conditions referred to in point (a) of paragraph 4 taking into account the criteria for assessing liquidity under point (17) of Article 2(1) of Regulation (EU) No 600/2014; (e) type of operations and their specific time-frames referred to in point (b) of paragraph 4 that renders buy-in ineffective; (f) a methodology for the calculation of the cash compensation referred to in paragraph 7; (g) the conditions under which a participant is deemed consistently and systematically to fail to deliver the financial instruments as referred to in paragraph 9; and (h) the necessary settlement information referred to in the second subparagraph of paragraph 10. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 8 Enforcement 1. The competent authority of the CSD that operates the securities settlement system, the relevant authority responsible for the oversight of the securities settlement system concerned as well as the competent authorities for the supervision of trading venues, investment firms and CCPs shall be competent for ensuring that Articles 6 and 7 are applied by the institutions subject to their supervision and for monitoring the penalties imposed. Where necessary, the respective competent authorities shall cooperate closely. Member States shall inform ESMA about the designated competent authorities that are part of the supervision structure at the national level. 2. In order to ensure consistent, efficient and effective supervisory practices within the Union in relation to Articles 6 and 7 of this Regulation, ESMA may, in close cooperation with the members of the ESCB, issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010. 3. An infringement of the rules under this Title shall not affect the validity of a private contract on financial instruments or the possibility for the parties to enforce the provisions of a private contract on financial instruments. CHAPTER IV Internalised settlement Article 9 Settlement internalisers 1. Settlement internalisers shall report to the competent authorities of their place of establishment on a quarterly basis the aggregated volume and value of all securities transactions that they settle outside securities settlement systems. Competent authorities shall without delay transmit the information received under the first subparagraph to ESMA and shall inform ESMA of any potential risk resulting from that settlement activity. 2. ESMA may, in close cooperation with the members of the ESCB, develop draft regulatory technical standards further specifying the content of such reporting. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 3. ESMA shall develop draft implementing technical standards to establish standard forms, templates and procedures for the reporting and transmission of information referred to in paragraph 1. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. TITLE III CENTRAL SECURITIES DEPOSITORIES CHAPTER I Authorisation and supervision of CSDs Section 1 Authorities responsible for authorisation and supervision of CSDs Article 10 Competent authority Without prejudice to the oversight by the members of the ESCB referred to in Article 12(1), a CSD shall be authorised and supervised by the competent authority of its home Member State. Article 11 Designation of the competent authority 1. Each Member State shall designate the competent authority responsible for carrying out the duties under this Regulation for the authorisation and supervision of CSDs established in its territory and shall inform ESMA thereof. Where a Member State designates more than one competent authority, it shall determine their respective roles and shall designate a single authority to be responsible for cooperation with other Member States\u2019 competent authorities, the relevant authorities, ESMA, and EBA, where specifically referred to in this Regulation. 2. ESMA shall publish on its website a list of the competent authorities designated in accordance with paragraph 1. 3. The competent authorities shall have the supervisory and investigatory powers necessary for the exercise of their functions. Article 12 Relevant authorities 1. The following authorities shall be involved in the authorisation and supervision of CSDs where specifically referred to in this Regulation: (a) the authority responsible for the oversight of the securities settlement system operated by the CSD in the Member State whose law applies to that securities settlement system; (b) the central banks in the Union issuing the most relevant currencies in which settlement takes place; (c) where relevant, the central bank in the Union in whose books the cash leg of a securities settlement system operated by the CSD is settled. 2. ESMA shall publish on its website the list of the relevant authorities referred to in paragraph 1. 3. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards specifying the conditions under which the Union currencies referred to in point (b) of paragraph 1 are considered to be the most relevant, and efficient practical arrangements for the consultation of the relevant authorities referred to in points (b) and (c) of that paragraph. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 13 Exchange of information 1. Competent authorities, relevant authorities and ESMA shall, on request and without undue delay, provide one another with the information required for the purposes of carrying out their duties under this Regulation. 2. Competent authorities, relevant authorities, ESMA and other bodies or natural and legal persons receiving confidential information in the exercise of their duties under this Regulation shall use it only in the course of their duties. Article 14 Cooperation between authorities 1. Competent authorities, relevant authorities and ESMA shall cooperate closely, including by exchanging all relevant information for the application of this Regulation. Where appropriate and relevant, such cooperation shall include other public authorities and bodies, in particular those established or appointed under Directive 2003/87/EC. In order to ensure consistent, efficient and effective supervisory practices within the Union, including cooperation between competent authorities and relevant authorities in the different assessments necessary for the application of this Regulation, ESMA may, in close cooperation with the members of the ESCB, issue guidelines addressed to competent authorities in accordance with Article 16 of Regulation (EU) No 1095/2010. 2. The competent authorities shall, in the exercise of their general duties, duly consider the potential impact of their decisions on the stability of the financial system in all other Member States concerned, in particular in the emergency situations referred to in Article 15, based on the available information. Article 15 Emergency situations Without prejudice to the notification procedure provided for in Article 6(3) of Directive 98/26/EC, competent authorities and relevant authorities shall immediately inform ESMA, the European Systemic Risk Board established by Regulation (EU) No 1092/2010 of the European Parliament and of the Council (24) and each other of any emergency situation relating to a CSD, including of any developments in financial markets, which may have an adverse effect on market liquidity, the stability of a currency in which settlement takes place, the integrity of monetary policy or on the stability of the financial system in any of the Member States where the CSD or one of its participants are established. Section 2 Conditions and procedures for authorisation of CSDs Article 16 Authorisation of a CSD 1. Any legal person that falls within the definition of CSD shall obtain an authorisation from the competent authority of the Member State where it is established before commencing its activities. 2. The authorisation shall specify the core services listed in Section A of the Annex and non-banking-type ancillary services permitted under Section B of the Annex, which the CSD is authorised to provide. 3. A CSD shall comply at all times with the conditions necessary for authorisation. 4. A CSD as well as its independent auditors, shall, without undue delay, inform the competent authority of any substantive changes affecting the compliance with the conditions for authorisation. Article 17 Procedure for granting authorisation 1. The applicant CSD shall submit an application for authorisation to its competent authority. 2. The application for authorisation shall be accompanied by all information necessary to enable the competent authority to satisfy itself that the applicant CSD has established, at the time of the authorisation, all the necessary arrangements to meet its obligations as laid down in this Regulation. The application for authorisation shall include a programme of operations setting out the types of business envisaged and the structural organisation of the CSD. 3. Within 30 working days from the receipt of the application, the competent authority shall assess whether the application is complete. If the application is not complete, the competent authority shall set a time limit by which the applicant CSD has to provide additional information. The competent authority shall inform the applicant CSD when the application is considered to be complete. 4. From the moment when the application is considered to be complete, the competent authority shall transmit all information included in the application to the relevant authorities and consult those authorities concerning the features of the securities settlement system operated by the applicant CSD. Each relevant authority may inform the competent authority of its views within 3 months of the receipt of the information by the relevant authority. 5. Where the applicant CSD intends to provide services referred to in point (2) of Article 4(1) of Directive 2014/65/EU in addition to the provision of non-banking-type ancillary services explicitly listed in Section B of the Annex, the competent authority shall transmit all information included in the application to the authority referred to in Article 67 of Directive 2014/65/EU and consult that authority on the ability of the applicant CSD to comply with the requirements of Directive 2014/65/EU and of Regulation (EU) No 600/2014. 6. The competent authority shall, before granting authorisation to the applicant CSD, consult the competent authorities of the other Member State involved in the following cases: (a) the CSD is a subsidiary of a CSD authorised in another Member State; (b) the CSD is a subsidiary of the parent undertaking of a CSD authorised in another Member State; (c) the CSD is controlled by the same natural or legal persons who control a different CSD authorised in another Member State. 7. The consultation referred to in paragraph 6 shall cover the following: (a) the suitability of the shareholders and persons referred to in Article 27(6) and the reputation and experience of the persons who effectively direct the business of the CSD referred to in Article 27(1) and (4), where those shareholders and persons are common to the CSD and to a CSD authorised in another Member State; (b) whether the relations referred to in points (a), (b) and (c) of paragraph 6 between the CSD authorised in another Member State and the applicant CSD do not affect the ability of the latter to comply with the requirements of this Regulation. 8. Within six months from the submission of a complete application, the competent authority shall inform the applicant CSD in writing with a fully reasoned decision whether the authorisation has been granted or refused. 9. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the information that the applicant CSD is to provide to the competent authority in the application for authorisation. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 10. ESMA shall, in close cooperation with the members of the ESCB, develop draft implementing technical standards to establish standard forms, templates and procedures for the application for authorisation. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Article 18 Effects of the authorisation 1. The activities of the authorised CSD shall be limited to the provision of services covered by its authorisation or by notification in accordance with Article 19(8). 2. Securities settlement systems may be operated only by authorised CSDs, including central banks acting as CSDs. 3. An authorised CSD may have a participation only in a legal person whose activities are limited to the provision of services listed in Sections A and B of the Annex, unless such a participation is approved by its competent authority on the basis that it does not significantly increase the risk profile of the CSD. 4. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the criteria to be taken into account by the competent authorities to approve the participation of CSDs in legal persons other than those providing the services listed in Sections A and B of the Annex. Such criteria may include whether the services provided by that legal person are complementary to the services provided by a CSD, and the extent of the CSD\u2019s exposure to liabilities arising from such participation. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 19 Extension and outsourcing of activities and services 1. An authorised CSD shall submit an application for authorisation to the competent authority of its home Member State where it wishes to outsource a core service to a third party under Article 30 or extend its activities to one or more of the following: (a) additional core services listed in Section A of the Annex, not covered by the initial authorisation; (b) ancillary services permitted under, but not explicitly listed in Section B of the Annex, not covered by the initial authorisation; (c) the operation of another securities settlement system; (d) the settlement of all or part of the cash leg of its securities settlement system in the books of another settlement agent; (e) setting up an interoperable link, including those with third-country CSDs. 2. The granting of authorisation under paragraph 1 shall follow the procedure laid down in Article 17. The competent authority shall inform the applicant CSD whether the authorisation has been granted or refused within three months of the submission of a complete application. 3. CSDs established in the Union that intend to establish an interoperable link shall submit an application for authorisation as required under point (e) of paragraph 1, to their respective competent authorities. Those authorities shall consult each other regarding the approval of the CSD link. In the event of divergent decisions and if agreed by both competent authorities the matter may be referred to ESMA, which may act in accordance with the powers conferred on it under Article 19 of Regulation (EU) No 1095/2010. 4. The authorities referred to in paragraph 3 shall refuse to authorise a link only where such a CSD link would threaten the smooth and orderly functioning of the financial markets or cause systemic risk. 5. Interoperable links of CSDs that outsource some of their services related to those interoperable links to a public entity in accordance with Article 30(5) and CSD links that are not referred to in point (e) of paragraph 1 shall not be subject to authorisation under that point but shall be notified to the CSDs\u2019 competent and relevant authorities prior to their implementation by providing all relevant information that allows such authorities to assess compliance with the requirements provided in Article 48. 6. A CSD established and authorised in the Union may maintain or establish a link with a third-country CSD in accordance with the conditions and procedures provided in this Article. Where links are established with a third-country CSD the information provided by the requesting CSD shall allow the competent authority to evaluate whether such links fulfil the requirements provided in Article 48 or the requirements that are equivalent to those provided in Article 48. 7. The competent authority of the requesting CSD shall require that CSD to discontinue a CSD link that has been notified when such link does not fulfil the requirements provided for in Article 48 and thereby would threaten the smooth and orderly functioning of the financial markets or cause systemic risk. Where a competent authority requires the CSD to discontinue a CSD link, it shall follow the procedure laid down in Article 20(2) and (3). 8. The additional ancillary services explicitly listed in Section B of the Annex shall not be subject to authorisation, but shall be notified to the competent authority prior to their provision. Article 20 Withdrawal of authorisation 1. Without prejudice to any remedial actions or measures under Title V, the competent authority of the home Member State shall withdraw the authorisation in any of the following circumstances, where the CSD: (a) has not made use of the authorisation during 12 months, expressly renounces the authorisation or has provided no services or performed no activity during the preceding six months; (b) has obtained the authorisation by making false statements or by any other unlawful means; (c) no longer complies with the conditions under which authorisation was granted and has not taken the remedial actions requested by the competent authority within a set time-frame; (d) has seriously or systematically infringed the requirements laid down in this Regulation or, where applicable, in Directive 2014/65/EU or Regulation (EU) No 600/2014. 2. From the moment when it becomes aware of one of the circumstances referred to in paragraph 1, the competent authority shall immediately consult the relevant authorities and, where applicable, the authority referred to in Article 67 of Directive 2014/65/EU on the necessity to withdraw the authorisation. 3. ESMA and any relevant authority and, where applicable, the authority referred to in Article 67 of Directive 2014/65/EU may, at any time, request that the competent authority of the home Member State examines whether the CSD still complies with the conditions under which the authorisation was granted. 4. The competent authority may limit the withdrawal of authorisation to a particular service, activity, or financial instrument. 5. A CSD shall establish, implement and maintain adequate procedures ensuring the timely and orderly settlement and transfer of the assets of clients and participants to another CSD in the event of a withdrawal of authorisation referred to in paragraph 1. Article 21 CSD register 1. Decisions taken by competent authorities under Articles 16, 19 and 20 shall be immediately communicated to ESMA. 2. Central banks shall without undue delay inform ESMA of any securities settlement system that they operate. 3. The name of each CSD operating in compliance with this Regulation and to which authorisation or recognition has been granted pursuant to Article 16, 19 or 25 shall be entered in a register specifying the services and, where applicable, classes of financial instruments for which the CSD has been authorised. The register shall include branches operated by the CSD in other Member States, CSD links and the information required under Article 31 where Member States have made use of the possibility provided for in that Article. ESMA shall make the register available on its dedicated website and keep it up to date. Section 3 Supervision of CSDs Article 22 Review and evaluation 1. The competent authority shall, at least on an annual basis, review the arrangements, strategies, processes and mechanisms implemented by a CSD with respect to compliance with this Regulation and evaluate the risks to which the CSD is, or might be, exposed or which it creates for the smooth functioning of securities markets. 2. The competent authority shall require the CSD to submit to the competent authority an adequate recovery plan to ensure continuity of its critical operations. 3. The competent authority shall ensure that an adequate resolution plan is established and maintained for each CSD so as to ensure continuity of at least its core functions, having regard to the size, systemic importance, nature, scale and complexity of the activities of the CSD concerned and any relevant resolution plan established in accordance with Directive 2014/59/EU. 4. The competent authority shall establish the frequency and depth of the review and evaluation referred to in paragraph 1 having regard to the size, systemic importance, nature, scale and complexity of the activities of the CSD concerned. The review and evaluation shall be updated at least on an annual basis. 5. The competent authority shall subject the CSD to on-site inspections. 6. When performing the review and evaluation referred to in paragraph 1, the competent authority shall, at an early stage, consult the relevant authorities, in particular concerning the functioning of the securities settlement systems operated by the CSD and, where applicable, the authority referred to in Article 67 of Directive 2014/65/EU. 7. The competent authority shall regularly, and at least once a year, inform the relevant authorities and, where applicable, the authority referred to in Article 67 of Directive 2014/65/EU of the results, including any remedial actions or penalties, of the review and evaluation referred to in paragraph 1. 8. When performing the review and evaluation referred to in paragraph 1, the competent authorities responsible for supervising CSDs which maintain the types of relations referred to in points (a), (b) and (c) of Article 17(6) shall supply one another with all relevant information that is likely to facilitate their tasks. 9. The competent authority shall require a CSD that does not meet the requirements of this Regulation to take at an early stage the necessary actions or steps to address the situation. 10. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the following: (a) the information that the CSD is to provide to the competent authority for the purposes of the review and evaluation referred to in paragraph 1; (b) the information that the competent authority is to supply to the relevant authorities, as set out in paragraph 7; (c) the information that the competent authorities referred to in paragraph 8 are to supply one another. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with in Articles 10 to 14 of Regulation (EU) No 1095/2010. 11. ESMA shall, in close cooperation with the members of the ESCB, develop draft implementing technical standards to determine standard forms, templates and procedures for the provision of information referred to in the first subparagraph of paragraph 10. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Section 4 Provision of services in another member state Article 23 Freedom to provide services in another Member State 1. An authorised CSD may provide services referred to in the Annex within the territory of the Union, including through setting up a branch, provided that those services are covered by the authorisation. 2. An authorised CSD that intends to provide the core services referred to in points 1 and 2 of Section A of the Annex in relation to financial instruments constituted under the law of another Member State referred to in Article 49(1) or to set up a branch in another Member State shall be subject to the procedure referred to in paragraphs 3 to 7. 3. Any CSD wishing to provide the services referred to in paragraph 2 within the territory of another Member State for the first time, or to change the range of those services provided shall communicate the following information to the competent authority of the home Member State: (a) the Member State in which the CSD intends to operate; (b) a programme of operations stating in particular the services which the CSD intends to provide; (c) the currency or currencies that the CSD intends to process; (d) where there is a branch, the organisational structure of the branch and the names of those responsible for the management of the branch; (e) where relevant, an assessment of the measures the CSD intends to take to allow its users to comply with the national law referred to in Article 49(1). 4. Within three months from the receipt of the information referred to in paragraph 3, the competent authority of the home Member State shall communicate that information to the competent authority of the host Member State unless, by taking into account the provision of services envisaged, it has reasons to doubt the adequacy of the administrative structure or the financial situation of the CSD wishing to provide its services in the host Member State. The competent authority of the host Member State shall without delay inform the relevant authorities of that Member State of any communication received under the first subparagraph. 5. Where the competent authority of the home Member State decides in accordance with paragraph 4 not to communicate all the information referred to in paragraph 3 to the competent authority of the host Member State it shall give reasons for its refusal to the CSD concerned within three months of receiving all the information and inform the competent authority of the host Member State of its decision in relation to point (a) of paragraph 6. Where information is shared in response to such a request the competent authority of the host Member State shall not issue the communication referred to in point (a) of paragraph 6. 6. The CSD may start providing the services referred to in paragraph 2 in the host Member State under the following conditions: (a) on receipt of a communication from the competent authority in the host Member State acknowledging receipt by the latter of the communication referred to in paragraph 4 and, where relevant, approving the assessment referred to in point (e) of paragraph 3; (b) in the absence of any receipt of a communication, after three months from the date of transmission of the communication referred to in paragraph 4. 7. In the event of a change in any of the information communicated in accordance with paragraph 3, a CSD shall give written notice of that change to the competent authority of the home Member State at least one month before implementing the change. The competent authority of the host Member State shall also be informed of that change without delay by the competent authority of the home Member State. Article 24 Cooperation between authorities of the home Member State and of the host Member State and peer review 1. Where a CSD authorised in one Member State has set up a branch in another Member State, the competent authority of the home Member State and the competent authority of the host Member State shall cooperate closely in the performance of their duties provided for in this Regulation, in particular when carrying out on-site inspections in that branch. The competent authority of the home Member State and of the host Member State may, in the exercise of their responsibilities, carry out on-site inspections in that branch after informing the competent authority of the host Member State or of the home Member State respectively. 2. The competent authority of the home Member State or of the host Member State may require CSDs which provide services in accordance with Article 23 to report to them periodically on their activities in that host Member State, including for the purpose of collecting statistics. The competent authority of the host Member State shall, on request from the competent authority of the home Member State, provide those periodic reports to the competent authority of the home Member State. 3. The competent authority of the home Member State of the CSD shall, on the request of the competent authority of the host Member State and without delay, communicate the identity of the issuers and participants in the securities settlement systems operated by the CSD which provides services in that host Member State and any other relevant information concerning the activities of that CSD in the host Member State. 4. Where, taking into account the situation of the securities markets in the host Member State, the activities of a CSD have become of substantial importance for the functioning of the securities markets and the protection of the investors in that host Member State, the competent authority of the home Member State and of the host Member State and the relevant authorities of the home Member State and of the host Member State shall establish cooperation arrangements for the supervision of the activities of that CSD in the host Member State. Where a CSD has become of substantial importance for the functioning of the securities markets and the protection of the investors in more than one host Member State, the home Member State may decide that such cooperation arrangements are to include colleges of supervisors. 5. Where the competent authority of the host Member State has clear and demonstrable grounds for believing that a CSD providing services within its territory in accordance with Article 23 is in breach of the obligations arising from the provisions of this Regulation, it shall refer those findings to the competent authority of the home Member State and to ESMA. Where, despite measures taken by the competent authority of the home Member State or because such measures prove inadequate, the CSD persists in acting in infringement of the obligations arising from the provisions of this Regulation, after informing the competent authority of the home Member State, the competent authority of the host Member State shall take all the appropriate measures needed in order to ensure compliance with the provisions of this Regulation within the territory of the host Member State. ESMA shall be informed of such measures without delay. The competent authority of the host Member State and of the home Member State may refer the matter to ESMA, which may act in accordance with the powers conferred on it under Article 19 of Regulation (EU) No 1095/2010. 6. Without prejudice to Article 30 of Regulation (EU) No 1095/2010, ESMA shall, after consulting the members of the ESCB, organise and conduct, at least every three years, a peer review of the supervision of CSDs which make use of the freedom to provide services in another Member State in accordance with Article 23 or to participate in an interoperable link. In the context of the peer review referred to in the first subparagraph ESMA shall, where appropriate, also request opinions or advice from the Securities and Markets Stakeholder Group referred to in Article 37 of Regulation (EU) No 1095/2010. 7. The Commission shall be empowered to adopt delegated acts in accordance with Article 67 concerning measures for establishing the criteria under which the operations of a CSD in a host Member State could be considered to be of substantial importance for the functioning of the securities markets and the protection of the investors in that host Member State. 8. ESMA shall, in close cooperation with the members of the ESCB, develop draft implementing technical standards to establish standard forms, templates and procedures for the cooperation referred to in paragraphs 1, 3 and 5. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Section 5 Relations with third countries Article 25 Third countries 1. Third-country CSDs may provide services referred to in the Annex within the territory of the Union, including through setting up a branch. 2. Notwithstanding paragraph 1, a third-country CSD that intends to provide the core services referred to in points (1) and (2) of Section A of the Annex in relation to financial instruments constituted under the law of a Member State referred to in the second subparagraph of Article 49(1) or to set up a branch in a Member State shall be subject to the procedure referred to in paragraphs 4 to 11 of this Article. 3. A CSD established and authorised in the Union may maintain or establish a link with a third-country CSD in accordance with Article 48. 4. After consulting the authorities referred to in paragraph 5, ESMA may recognise a third-country CSD that has applied for recognition to provide the services referred to in paragraph 2, where the following conditions are met: (a) the Commission has adopted a decision in accordance with paragraph 9; (b) the third-country CSD is subject to effective authorisation, supervision and oversight or, if the securities settlement system is operated by a central bank, oversight, ensuring full compliance with the prudential requirements applicable in that third country; (c) cooperation arrangements between ESMA and the responsible authorities in that third country (\u2018responsible third-country authorities\u2019) have been established pursuant to paragraph 10; (d) where relevant, the third-country CSD takes the necessary measures to allow its users to comply with the relevant national law of the Member State in which the third-country CSD intends to provide CSD services, including the law referred to in the second subparagraph of Article 49(1), and the adequacy of those measures has been confirmed by the competent authorities of the Member State in which the third-country CSD intends to provide CSD services. 5. When assessing whether the conditions referred to in paragraph 4 are met, ESMA shall consult: (a) the competent authorities of the Member States in which the third-country CSD intends to provide CSD services, in particular, on how the third-country CSD intends to comply with the requirement referred to in point (d) of paragraph 4; (b) the relevant authorities; (c) the responsible third-country authorities entrusted with the authorisation, supervision and oversight of CSDs. 6. The third-country CSD referred to in paragraph 2 shall submit its application for recognition to ESMA. The applicant CSD shall provide ESMA with all information deemed to be necessary for its recognition. Within 30 working days from the receipt of the application, ESMA shall assess whether the application is complete. If the application is not complete, ESMA shall set a time limit by which the applicant CSD has to provide additional information. The competent authorities of the Member States in which the third-country CSD intends to provide CSD services shall assess the compliance of the third-country CSD with the law referred to in point (d) of paragraph 4 and inform ESMA with a fully reasoned decision whether the compliance is met or not within three months from the receipt of all the necessary information from ESMA. The recognition decision shall be based on the criteria laid down in paragraph 4. Within six months from the submission of a complete application, ESMA shall inform the applicant CSD in writing with a fully reasoned decision whether the recognition has been granted or refused. 7. The competent authorities of the Member States in which the third-country CSD, duly recognised under paragraph 4, provides CSD services, in close cooperation with ESMA, may request the responsible third-country authorities to: (a) report periodically on the third-country CSD\u2019s activities in those host Member States, including for the purpose of collecting statistics; (b) communicate, within an appropriate time-frame, the identity of the issuers and participants in the securities settlement systems operated by the third-country CSD which provides services in that host Member State and any other relevant information concerning the activities of that third-country CSD in the host Member State. 8. ESMA shall, after consulting the authorities referred to in paragraph 5, review the recognition of the third-country CSD in the event of extensions by that CSD in the Union of its services under the procedure laid down in paragraphs 4, 5 and 6. ESMA shall withdraw the recognition of that CSD where the conditions laid down in paragraph 4 are no longer met, or in the circumstances referred to in Article 20. 9. The Commission may adopt implementing acts to determine that the legal and supervisory arrangements of a third country ensure that CSDs authorised in that third country comply with legally binding requirements which are in effect equivalent to the requirements laid down in this Regulation, that those CSDs are subject to effective supervision, oversight and enforcement in that third country on an ongoing basis and that the legal framework of that third country provides for an effective equivalent system for the recognition of CSDs authorised under third-country legal regimes. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68(2). In making the determination referred to in the first subparagraph, the Commission may also consider whether the legal and supervisory arrangements of a third country reflect the internationally agreed CPSS-IOSCO standards, in so far as the latter do not conflict with the requirements laid down in this Regulation. 10. In accordance with Article 33(1) of Regulation (EU) No 1095/2010, ESMA shall establish cooperation arrangements with the responsible third-country authorities whose legal and supervisory frameworks have been recognised as equivalent to this Regulation in accordance with paragraph 9. Such arrangements shall specify at least: (a) the mechanism for the exchange of information between ESMA, the competent authorities of the host Member State and the third-country responsible authorities, including access to all information regarding the CSDs authorised in third countries that is requested by ESMA and in particular access to information in the cases referred to in paragraph 7; (b) the mechanism for prompt notification of ESMA where a third-country responsible authority deems a CSD that it is supervising to infringe the conditions of its authorisation or of other applicable law; (c) the procedures concerning the coordination of supervisory activities including, where appropriate, on-site inspections. Where a cooperation agreement provides for transfers of personal data by a Member State, such transfers shall comply with the provisions of Directive 95/46/EC and where a cooperation agreement provides for transfers of personal data by ESMA, such transfers shall comply with the provisions of Regulation (EU) No 45/2001. 11. Where a third-country CSD has been recognised, in accordance with paragraphs 4 to 8, it may provide services referred to in the Annex within the territory of the Union, including by setting up a branch. 12. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the information that the applicant CSD is to provide to ESMA in its application for recognition under paragraph 6. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. CHAPTER II Requirements for CSDs Section 1 Organisational requirements Article 26 General provisions 1. A CSD shall have robust governance arrangements, which include a clear organisational structure with well-defined, transparent and consistent lines of responsibility, effective processes to identify, manage, monitor and report the risks to which it is or might be exposed, and adequate remuneration policies and internal control mechanisms, including sound administrative and accounting procedures. 2. A CSD shall adopt policies and procedures which are sufficiently effective so as to ensure compliance with this Regulation, including compliance of its managers and employees with all the provisions of this Regulation. 3. A CSD shall maintain and operate effective written organisational and administrative arrangements to identify and manage any potential conflicts of interest between itself, including its managers, employees, members of the management body or any person directly or indirectly linked to them, and its participants or their clients. It shall maintain and implement adequate resolution procedures where possible conflicts of interest occur. 4. A CSD shall make its governance arrangements and the rules governing its activity available to the public. 5. A CSD shall have appropriate procedures for its employees to report internally potential infringements of this Regulation through a specific channel. 6. A CSD shall be subject to regular and independent audits. The results of these audits shall be communicated to the management body and made available to the competent authority and, where appropriate taking into account potential conflicts of interest between the members of the user committee and the CSD, to the user committee. 7. Where a CSD is part of a group of undertakings including other CSDs or credit institutions referred to in Title IV, it shall adopt detailed policies and procedures specifying how the requirements laid down in this Article apply to the group and to the different entities in the group. 8. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards specifying at the CSD level and at the group level as referred to in paragraph 7: (a) the monitoring tools for the risks of the CSDs referred to in paragraph 1; (b) the responsibilities of the key personnel in respect of the risks of the CSDs referred to in paragraph 1; (c) the potential conflicts of interest referred to in paragraph 3; (d) the audit methods referred to in paragraph 6; and (e) the circumstances in which it would be appropriate, taking into account potential conflicts of interest between the members of the user committee and the CSD, to share audit findings with the user committee in accordance with paragraph 6. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 27 Senior management, management body and shareholders 1. The senior management of a CSD shall be of sufficiently good repute and experience so as to ensure the sound and prudent management of the CSD. 2. A CSD shall have a management body of which at least one third, but no less than two, of its members are independent. 3. The remuneration of the independent and other non-executive members of the management body shall not be linked to the business performance of the CSD. 4. The management body shall be composed of suitable members of sufficiently good repute with an appropriate mix of skills, experience and knowledge of the entity and of the market. The non-executive members of the management body shall decide on a target for the representation of the under-represented gender in the management body and prepare a policy on how to increase the number of the under-represented gender in order to meet that target. The target, policy and its implementation shall be made public. 5. A CSD shall clearly determine the role and responsibilities of the management body in accordance with the relevant national law. A CSD shall make the minutes of the meetings of the management body available to the competent authority and the auditor upon request. 6. The CSD\u2019s shareholders and persons who are in a position to exercise, directly or indirectly, control over the management of the CSD shall be suitable to ensure the sound and prudent management of the CSD. 7. A CSD shall: (a) provide the competent authority with, and make public, information regarding the ownership of the CSD, and in particular, the identity and scale of interests of any parties in a position to exercise control over the operation of the CSD; (b) inform and seek approval from its competent authority of any decision to transfer ownership rights which give rise to a change in the identity of the persons exercising control over the operation of the CSD. After receiving approval from its competent authority, the CSD shall make public the transfer of ownership rights. Any natural or legal person shall inform without undue delay the CSD and its competent authority of a decision to acquire or dispose of its ownership rights that give rise to a change in the identity of the persons exercising control over the operation of the CSD. 8. Within 60 working days from the receipt of the information referred to in paragraph 7, the competent authority shall take a decision on the proposed changes in the control of the CSD. The competent authority shall refuse to approve proposed changes in the control of the CSD where there are objective and demonstrable grounds for believing that they would pose a threat to the sound and prudent management of the CSD or to the ability of the CSD to comply with this Regulation. Article 28 User committee 1. A CSD shall establish user committees for each securities settlement system it operates, which shall be composed of representatives of issuers and of participants in such securities settlement systems. The advice of the user committee shall be independent from any direct influence by the management of the CSD. 2. A CSD shall define in a non-discriminatory way the mandate for each established user committee, the governance arrangements necessary to ensure its independence and its operational procedures, as well as the admission criteria and the election mechanism for user committee members. The governance arrangements shall be publicly available and shall ensure that the user committee reports directly to the management body and holds regular meetings. 3. User committees shall advise the management body on key arrangements that impact on their members, including the criteria for accepting issuers or participants in their respective securities settlement systems and on service level. 4. User committees may submit a non-binding opinion to the management body containing detailed reasons regarding the pricing structures of the CSD. 5. Without prejudice to the right of competent authorities to be duly informed, the members of the user committees shall be bound by confidentiality. Where the chairman of a user committee determines that a member has an actual or a potential conflict of interest in relation to a particular matter, that member shall not be allowed to vote on that matter. 6. A CSD shall promptly inform the competent authority and the user committee of any decision in which the management body decides not to follow the advice of the user committee. The user committee may inform the competent authority of any areas in which it considers that the advice of the user committee has not been followed. Article 29 Record keeping 1. A CSD shall maintain, for a period of at least 10 years, all its records on the services and activities, including on the ancillary services referred to in Sections B and C of the Annex, so as to enable the competent authority to monitor the compliance with the requirements under this Regulation. 2. A CSD shall make the records referred to in paragraph 1 available upon request to the competent authority and the relevant authorities and any other public authority which under Union law or national law of its home Member State has a power to require access to such records for the purpose of fulfilling their mandate. 3. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the details of the records referred to in paragraph 1 to be retained for the purpose of monitoring the compliance of CSDs with the provisions of this Regulation. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 4. ESMA shall, in close cooperation with the members of the ESCB, develop draft implementing technical standards to establish the format of the records referred to in paragraph 1 to be retained for the purpose of monitoring the compliance of CSDs with the provisions of this Regulation. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Article 30 Outsourcing 1. Where a CSD outsources services or activities to a third party, it shall remain fully responsible for discharging all of its obligations under this Regulation and shall comply at all times with the following conditions: (a) outsourcing does not result in the delegation of its responsibility; (b) the relationship and obligations of the CSD towards its participants or issuers are not altered; (c) the conditions for the authorisation of the CSD do not effectively change; (d) outsourcing does not prevent the exercise of supervisory and oversight functions, including on-site access to acquire any relevant information needed to fulfil those functions; (e) outsourcing does not result in depriving the CSD of the systems and controls necessary to manage the risks it faces; (f) the CSD retains the expertise and resources necessary for evaluating the quality of the services provided, the organisational and capital adequacy of the service provider, for supervising the outsourced services effectively and for managing the risks associated with the outsourcing on an ongoing basis; (g) the CSD has direct access to the relevant information of the outsourced services; (h) the service provider cooperates with the competent authority and the relevant authorities in connection with the outsourced activities; (i) the CSD ensures that the service provider meets the standards set down by the relevant data protection law which would apply if the service providers were established in the Union. The CSD is responsible for ensuring that those standards are set out in a contract between the parties and that those standards are maintained. 2. The CSD shall define in a written agreement its rights and obligations and those of the service provider. The outsourcing agreement shall allow the CSD to terminate the agreement. 3. A CSD and a service provider shall make available upon request to the competent authority and the relevant authorities all information necessary to enable them to assess the compliance of the outsourced activities with the requirements of this Regulation. 4. The outsourcing of a core service shall be subject to authorisation under Article 19 by the competent authority. 5. Paragraphs 1 to 4 shall not apply where a CSD outsources some of its services or activities to a public entity and where that outsourcing is governed by a dedicated legal, regulatory and operational framework which has been jointly agreed and formalised by the public entity and the relevant CSD and agreed by the competent authorities on the basis of the requirements established in this Regulation. Article 31 Services provided by parties other than CSDs 1. Notwithstanding Article 30 and where required by national law, a person other than CSD may be responsible for recording book entries into securities accounts maintained by CSDs. 2. Member States that allow parties other than CSDs to provide certain core services referred to in Section A of the Annex in accordance with paragraph 1 shall specify in their national law the requirements that will apply in such a case. Those requirements shall include the provisions of this Regulation which shall apply both to the CSD and, where relevant, to the other party concerned. 3. Member States that allow parties other than CSDs to provide certain core services referred to in Section A of the Annex in accordance with paragraph 1 shall communicate to ESMA all the relevant information concerning the provision of such services, including their relevant national law. ESMA shall include such information in the CSD register referred to in Article 21. Section 2 Conduct of business rules Article 32 General provisions 1. A CSD shall have clearly defined goals and objectives that are achievable, such as in the areas of minimum service levels, risk-management expectations and business priorities. 2. A CSD shall have transparent rules for the handling of complaints. Article 33 Requirements for participation 1. For each securities settlement system it operates a CSD shall have publicly disclosed criteria for participation which allow fair and open access for all legal persons that intend to become participants. Such criteria shall be transparent, objective, and non-discriminatory so as to ensure fair and open access to the CSD with due regard to risks to financial stability and the orderliness of markets. Criteria that restrict access shall be permitted only to the extent that their objective is to justifiably control a specified risk for the CSD. 2. A CSD shall treat requests for access promptly by providing a response to such requests within one month at the latest and shall make the procedures for treating access requests publicly available. 3. A CSD shall deny access to a participant meeting the criteria referred to in paragraph 1 only where duly justified in writing and based on a comprehensive risk assessment. In the event of a refusal, the requesting participant has the right to complain to the competent authority of the CSD that has refused access. That competent authority shall duly examine the complaint by assessing the reasons for refusal and shall provide the requesting participant with a reasoned reply. That competent authority shall consult the competent authority of the place of establishment of the requesting participant on its assessment of the complaint. Where the authority of the requesting participant disagrees with the assessment provided, any one of the two competent authorities may refer the matter to ESMA, which may act in accordance with the powers conferred on it under Article 19 of Regulation (EU) No 1095/2010. Where the refusal by the CSD to grant access to the requesting participant is deemed to be unjustified, the competent authority of the CSD that has refused access shall issue an order requiring that CSD to grant access to the requesting participant. 4. A CSD shall have objective and transparent procedures for the suspension and orderly exit of participants that no longer meet the criteria for participation referred to in paragraph 1. 5. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the risks to be taken into account by CSDs when carrying out a comprehensive risk assessment, and by competent authorities when assessing the reasons for refusal in accordance with paragraph 3 and the elements of the procedure referred to in paragraph 3. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 6. ESMA shall, in close cooperation with the members of the ESCB, develop draft implementing technical standards to establish standard forms and templates for the procedure referred to in paragraph 3. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Article 34 Transparency 1. For each securities settlement system it operates, as well as for each of the other core services it performs, a CSD shall publicly disclose the prices and fees associated with the core services listed in Section A of the Annex that they provide. It shall disclose the prices and fees of each service and function provided separately, including discounts and rebates and the conditions to benefit from those reductions. It shall allow its clients separate access to the specific services provided. 2. A CSD shall publish its price list so as to facilitate the comparison of offers and to allow clients to anticipate the price they shall have to pay for the use of services. 3. A CSD shall be bound by its published pricing policy for its core services. 4. A CSD shall provide its clients with information that allows reconciling invoices with the published price lists. 5. A CSD shall disclose to all clients information that allows them to assess the risks associated with the services provided. 6. A CSD shall account separately for costs and revenues of the core services provided and shall disclose that information to the competent authority. 7. A CSD shall account for the cost and revenue of the ancillary services provided as a whole and shall disclose that information to the competent authority. 8. In order to ensure effective application of Union competition rules and enable the identification, inter alia, of cross-subsidisation of ancillary services by core services, a CSD shall maintain analytical accounting for its activities. Such analytical accounts shall at least separate the costs and revenues associated with each of its core services from those associated with ancillary services. Article 35 Communication procedures with participants and other market infrastructures CSDs shall use in their communication procedures with participants of the securities settlement systems they operate, and with the market infrastructures they interface with international open communication procedures and standards for messaging and reference data in order to facilitate efficient recording, payment and settlement. Section 3 Requirements for CSD services Article 36 General provisions For each securities settlement system it operates a CSD shall have appropriate rules and procedures, including robust accounting practices and controls, to help ensure the integrity of securities issues, and reduce and manage the risks associated with the safekeeping and settlement of transactions in securities. Article 37 Integrity of the issue 1. A CSD shall take appropriate reconciliation measures to verify that the number of securities making up a securities issue or part of a securities issue submitted to the CSD is equal to the sum of securities recorded on the securities accounts of the participants of the securities settlement system operated by the CSD and, where relevant, on owner accounts maintained by the CSD. Such reconciliation measures shall be conducted at least daily. 2. Where appropriate and if other entities are involved in the reconciliation process for a certain securities issue, such as the issuer, registrars, issuance agents, transfer agents, common depositories, other CSDs or other entities, the CSD and any such entities shall organise adequate cooperation and information exchange measures with each other so that the integrity of the issue is maintained. 3. Securities overdrafts, debit balances or securities creation shall not be allowed in a securities settlement system operated by a CSD. 4. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the reconciliation measures a CSD is to take under paragraphs 1, 2 and 3. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 38 Protection of securities of participants and those of their clients 1. For each securities settlement system it operates, a CSD shall keep records and accounts that shall enable it, at any time and without delay, to segregate in the accounts with the CSD, the securities of a participant from those of any other participant and, if applicable, from the CSD\u2019s own assets. 2. A CSD shall keep records and accounts that enable any participant to segregate the securities of the participant from those of the participant\u2019s clients. 3. A CSD shall keep records and accounts that enable any participant to hold in one securities account the securities that belong to different clients of that participant (\u2018omnibus client segregation\u2019) 4. A CSD shall keep records and accounts that enable a participant to segregate the securities of any of the participant\u2019s clients, if and as required by the participant (\u2018individual client segregation\u2019). 5. A participant shall offer its clients at least the choice between omnibus client segregation and individual client segregation and inform them of the costs and risks associated with each option. However, a CSD and its participants shall provide individual clients segregation for citizens and residents of, and legal persons established in, a Member State where required under the national law of the Member State under which the securities are constituted as it stands at 17 September 2014. That obligation shall apply as long as the national law is not amended or repealed and its objectives are still valid. 6. CSDs and their participants shall publicly disclose the levels of protection and the costs associated with the different levels of segregation that they provide and shall offer those services on reasonable commercial terms. Details of the different levels of segregation shall include a description of the main legal implications of the respective levels of segregation offered, including information on the insolvency law applicable in the relevant jurisdictions. 7. A CSD shall not use for any purpose securities that do not belong to it. A CSD may however use securities of a participant where it has obtained that participant\u2019s prior express consent. The CSD shall require its participants to obtain any necessary prior consent from their clients. Article 39 Settlement finality 1. A CSD shall ensure that the securities settlement system it operates offers adequate protection to participants. Member States shall designate and notify the securities settlement systems operated by CSDs according to the procedures referred to in point (a) of Article 2 of Directive 98/26/EC. 2. A CSD shall ensure that each securities settlement system that it operates defines the moments of entry and of irrevocability of transfer orders in that securities settlement system in accordance with Articles 3 and 5 of Directive 98/26/EC. 3. A CSD shall disclose the rules governing the finality of transfers of securities and cash in a securities settlement system. 4. Paragraphs 2 and 3 shall apply without prejudice to the provisions applicable to CSD links, and without prejudice to paragraph 8 of Article 48. 5. A CSD shall take all reasonable steps to ensure that, in accordance with the rules referred to in paragraph 3, finality of transfers of securities and cash referred to in paragraph 3 is achieved either in real time or intra-day and in any case no later than by the end of the business day of the actual settlement date. 6. Where the CSD offers the services referred to in Article 40(2), it shall ensure that the cash proceeds of securities settlements shall be available for recipients to use no later than by the end of the business day of the intended settlement date. 7. All securities transactions against cash between direct participants in a securities settlement system operated by a CSD and settled in that securities settlement system shall be settled on a DVP basis. Article 40 Cash settlement 1. For transactions denominated in the currency of the country where the settlement takes place, a CSD shall settle the cash payments of its securities settlement system through accounts opened with a central bank of issue of the relevant currency where practical and available. 2. Where it is not practical and available to settle in central bank accounts as provided in paragraph 1, a CSD may offer to settle the cash payments for all or part of its securities settlement systems through accounts opened with a credit institution or through its own accounts. If a CSD offers to settle in accounts opened with a credit institution or through its own accounts, it shall do so in accordance with the provisions of Title IV. 3. A CSD shall ensure that any information provided to market participants about the risks and costs associated with settlement in the accounts of credit institutions or through its own accounts is clear, fair and not misleading. A CSD shall make available sufficient information to clients or potential clients to allow them to identify and evaluate the risks and costs associated with settlement in the accounts of credit institutions or through its own accounts and shall provide such information on request. Article 41 Participant default rules and procedures 1. For each securities settlement system it operates, a CSD shall have effective and clearly defined rules and procedures to manage the default of one or more of its participants ensuring that the CSD can take timely action to contain losses and liquidity pressures and continue to meet its obligations. 2. A CSD shall make its default rules and relevant procedures available to the public. 3. A CSD shall undertake with its participants and other relevant stakeholders periodic testing and review of its default procedures to ensure that they are practical and effective. 4. In order to ensure consistent application of this Article, ESMA may, in close cooperation with the members of the ESCB, issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010. Section 4 Prudential requirements Article 42 General requirements A CSD shall adopt a sound risk-management framework for comprehensively managing legal, business, operational and other direct or indirect risks, including measures to mitigate fraud and negligence. Article 43 Legal risks 1. For the purpose of its authorisation and supervision, as well as for the information of its clients, a CSD shall have rules, procedures, and contracts that are clear and understandable for all the securities settlement systems that it operates and all other services that it provides. 2. A CSD shall design its rules, procedures and contracts so that they are enforceable in all relevant jurisdictions, including in the case of the default of a participant. 3. A CSD conducting business in different jurisdictions shall take all reasonable steps to identify and mitigate the risks arising from potential conflicts of law across jurisdictions. Article 44 General business risk A CSD shall have robust management and control systems as well as IT tools in order to identify, monitor and manage general business risks, including losses from poor execution of business strategy, cash flows and operating expenses. Article 45 Operational risks 1. A CSD shall identify sources of operational risk, both internal and external, and minimise their impact through the deployment of appropriate IT tools, controls and procedures, including for all the securities settlement systems it operates. 2. A CSD shall maintain appropriate IT tools that ensure a high degree of security and operational reliability, and have adequate capacity. IT tools shall adequately deal with the complexity, variety and type of services and activities performed so as to ensure high standards of security, and the integrity and confidentiality of the information maintained. 3. For services that it provides as well as for each securities settlement system that it operates, a CSD shall establish, implement and maintain an adequate business continuity policy and disaster recovery plan to ensure the preservation of its services, the timely recovery of operations and the fulfilment of the CSD\u2019s obligations in the case of events that pose a significant risk of disrupting operations. 4. The plan referred to in paragraph 3 shall provide for the recovery of all transactions and participants\u2019 positions at the time of disruption to allow the participants of a CSD to continue to operate with certainty and to complete settlement on the scheduled date, including by ensuring that critical IT systems can promptly resume operations from the time of disruption. It shall include the setting-up of a second processing site with sufficient resources, capabilities and functionalities and appropriate staffing arrangements. 5. The CSD shall plan and carry out a programme of tests of the arrangements referred to in paragraphs 1 to 4. 6. A CSD shall identify, monitor and manage the risks that key participants in the securities settlement systems it operates, as well as service and utility providers, and other CSDs or other market infrastructures might pose to its operations. It shall, upon request, provide competent and relevant authorities with information on any such risk identified. It shall also inform the competent authority and relevant authorities without delay of any operational incidents resulting from such risks. 7. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the operational risks referred to in paragraphs 1 and 6 and the methods to test, to address or to minimise those risks, including the business continuity policies and disaster recovery plans referred to in paragraphs 3 and 4 and the methods of assessment thereof. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 46 Investment policy 1. A CSD shall hold its financial assets at central banks, authorised credit institutions or authorised CSDs. 2. A CSD shall have prompt access to its assets, where required. 3. A CSD shall invest its financial resources only in cash or in highly liquid financial instruments with minimal market and credit risk. Those investments shall be capable of being liquidated rapidly with minimal adverse price effect. 4. The amount of capital, including retained earnings and reserves of a CSD which are not invested in accordance with paragraph 3 shall not be taken into account for the purposes of Article 47(1). 5. A CSD shall ensure that its overall risk exposure to any individual authorised credit institution or authorised CSD with which it holds its financial assets remains within acceptable concentration limits. 6. ESMA shall, in close cooperation with EBA and the members of the ESCB, develop draft regulatory technical standards specifying the financial instruments that can be considered to be highly liquid with minimal market and credit risk as referred to in paragraph 3, the appropriate timeframe for access to assets referred to in paragraph 2 and the concentration limits as referred to in paragraph 5. Such draft regulatory technical standards shall, where appropriate, be aligned to the regulatory technical standards adopted in accordance with Article 47(8) of Regulation (EU) No 648/2012. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 47 Capital requirements 1. Capital, together with retained earnings and reserves of a CSD, shall be proportional to the risks stemming from the activities of the CSD. It shall be at all times sufficient to: (a) ensure that the CSD is adequately protected against operational, legal, custody, investment and business risks so that the CSD can continue to provide services as a going concern; (b) ensure an orderly winding-down or restructuring of the CSD\u2019s activities over an appropriate time span of at least six months under a range of stress scenarios. 2. A CSD shall maintain a plan for the following: (a) the raising of additional capital should its equity capital approach or fall below the requirements laid down in paragraph 1; (b) ensuring the orderly winding-down or restructuring of its operations and services where the CSD is unable to raise new capital. The plan shall be approved by the management body or an appropriate committee of the management body and updated regularly. Each update of the plan shall be provided to the competent authority. The competent authority may require the CSD to take additional measures or to make any alternative provision where the competent authority considers that the CSD\u2019s plan is insufficient. 3. EBA shall, in close cooperation with ESMA and the members of the ESCB, develop draft regulatory technical standards specifying requirements regarding the capital, retained earnings and reserves of a CSD referred to in paragraph 1. EBA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. Section 5 Requirements for CSD links Article 48 CSD links 1. Before establishing a CSD link and on an ongoing basis once the CSD link is established, all CSDs concerned shall identify, assess, monitor and manage all potential sources of risk for themselves and for their participants arising from the CSD link and take appropriate measures to mitigate them. 2. CSDs that intend to establish links shall submit an application for authorisation to the competent authority of the requesting CSD as required under point (e) of Article 19(1) or notify the competent and relevant authorities of the requesting CSD as required under Article 19(5). 3. A link shall provide adequate protection to the linked CSDs and their participants, in particular as regards possible credits taken by CSDs and the concentration and liquidity risks as a result of the link arrangement. A link shall be supported by an appropriate contractual arrangement that sets out the respective rights and obligations of the linked CSDs and, where necessary, of the CSDs\u2019 participants. A contractual arrangement with cross-jurisdictional implications shall provide for an unambiguous choice of law that govern each aspect of the link\u2019s operations. 4. In the event of a provisional transfer of securities between linked CSDs, retransfer of securities prior to the first transfer becoming final shall be prohibited. 5. A CSD that uses an indirect link or an intermediary to operate a CSD link with another CSD shall measure, monitor, and manage the additional risks arising from the use of that indirect link or intermediary and take appropriate measures to mitigate them. 6. Linked CSDs shall have robust reconciliation procedures to ensure that their respective records are accurate. 7. Links between CSDs shall permit DVP settlement of transactions between participants in linked CSDs, where practical and feasible. Detailed reasons for any CSD link not allowing for DVP settlement shall be notified to the relevant and competent authorities. 8. Interoperable securities settlement systems and CSDs, which use a common settlement infrastructure shall establish identical moments of: (a) entry of transfer orders into the system; (b) irrevocability of transfer orders. The securities settlement systems and CSDs referred to in the first subparagraph shall use equivalent rules concerning the moment of finality of transfers of securities and cash. 9. By 18 September 2019 all interoperable links between CSDs operating in Member States shall be, where applicable, DVP-settlement supporting links. 10. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the conditions provided for in paragraph 3 under which each type of link arrangement provides for adequate protection of the linked CSDs and of their participants, in particular where a CSD intends to participate in the securities settlement system operated by another CSD, the monitoring and managing of additional risks referred to in paragraph 5 arising from the use of intermediaries, the reconciliation methods referred to in paragraph 6, the cases where DVP settlement through CSD links is practical and feasible as provided for in paragraph 7 and the methods of assessment thereof. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Powers is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. CHAPTER III Access to CSDs Section 1 Access of issuers to CSDs Article 49 Freedom to issue in a CSD authorised in the Union 1. An issuer shall have the right to arrange for its securities admitted to trading on regulated markets or MTFs or traded on trading venues to be recorded in any CSD established in any Member State, subject to compliance by that CSD with conditions referred to in Article 23. Without prejudice to the issuer\u2019s right referred to in the first subparagraph, the corporate or similar law of the Member State under which the securities are constituted shall continue to apply. Member States shall ensure that a list of key relevant provisions of their law, as referred to in the second subparagraph, is compiled. Competent authorities shall communicate that list to ESMA by 18 December 2014. ESMA shall publish the list by 18 January 2015. The CSD may charge a reasonable commercial fee for the provision of its services to issuers on a cost-plus basis, unless otherwise agreed by both parties. 2. Where an issuer submits a request for recording its securities in a CSD, the latter shall treat such request promptly and in a non-discriminatory manner and provide a response to the requesting issuer within three months. 3. A CSD may refuse to provide services to an issuer. Such a refusal shall be based only on a comprehensive risk assessment or if that CSD does not provide the services referred to in point (1) of Section A of the Annex in relation to securities constituted under the corporate or similar law of the relevant Member State. 4. Without prejudice to Directive 2005/60/EC of the European Parliament and of the Council (25) and Commission Directive 2006/70/EC (26), where a CSD refuses to provide services to an issuer, it shall provide the requesting issuer with full written reasons for its refusal. In the case of a refusal, the requesting issuer shall have the right to complain to the competent authority of the CSD that refuses to provide its services. The competent authority of that CSD shall duly examine the complaint by assessing the reasons for refusal provided by the CSD and shall provide the issuer with a reasoned reply. The competent authority of the CSD shall consult the competent authority of the place of establishment of the requesting issuer on its assessment of the complaint. Where the competent authority of the place of establishment of the requesting issuer disagrees with that assessment, any one of the two competent authorities may refer the matter to ESMA, which may act in accordance with the powers conferred on it under Article 19 of Regulation (EU) No 1095/2010. Where the refusal by the CSD to provide its services to an issuer is deemed to be unjustified, the responsible competent authority shall issue an order requiring the CSD to provide its services to the requesting issuer. 5. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the risks to be taken into account by CSDs when carrying out a comprehensive risk assessment, and competent authorities assessing the reasons for refusal in accordance with paragraphs 3 and 4, and the elements of the procedure referred to in paragraph 4. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 6. ESMA shall, in close cooperation with the members of the ESCB, develop draft implementing technical standards to establish standard forms and templates for the procedure referred to in paragraph 4. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Section 2 Access between CSDs Article 50 Standard link access A CSD shall have the right to become a participant of another CSD and set up a standard link with that CSD in accordance with Article 33 and subject to the prior notification of the CSD link provided under Article 19(5). Article 51 Customised link access 1. Where a CSD requests another CSD to establish a customised link for having access to the latter, the receiving CSD shall reject such a request only on the basis of risk considerations. It shall not deny a request on the grounds of loss of market share. 2. The receiving CSD may charge a reasonable commercial fee on a cost-plus basis to the requesting CSD for making customised link access available, unless otherwise agreed by both parties. Article 52 Procedure for CSD links 1. When a CSD submits a request for access to another CSD pursuant to Articles 50 and 51, the latter shall treat such request promptly and shall provide a response to the requesting CSD within three months. 2. A CSD shall deny access to a requesting CSD only where such access would threaten the smooth and orderly functioning of the financial markets or cause systemic risk. Such a refusal shall be based only on a comprehensive risk assessment. Where a CSD refuses access, it shall provide the requesting CSD with full reasons for its refusal. In the case of a refusal, the requesting CSD has the right to complain to the competent authority of the CSD that has refused access. The competent authority of the receiving CSD shall duly examine the complaint by assessing the reasons for refusal and shall provide the requesting CSD with a reasoned reply. The competent authority of the receiving CSD shall consult the competent authority of the requesting CSD and the relevant authority of the requesting CSD referred to in point (a) of Article 12(1) on its assessment of the complaint. Where any of the authorities of the requesting CSD disagrees with the assessment provided, any one of the authorities may refer the matter to ESMA, which may act in accordance with the powers conferred on it under Article 19 of Regulation (EU) No 1095/2010. Where the refusal by the CSD to grant access to the requesting CSD is deemed to be unjustified, the competent authority of the receiving CSD shall issue an order requiring that CSD to grant access to the requesting CSD. 3. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the risks to be taken into account by CSDs when carrying out a comprehensive risk assessment, and by competent authorities when assessing the reasons for refusal in accordance with paragraph 2, and the elements of the procedure referred to in paragraph 2. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 4. ESMA shall, in close cooperation with the members of the ESCB, develop draft implementing technical standards to establish standard forms and templates for the procedures referred to in paragraphs 1 and 2. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Section 3 Access between a CSD and another market infrastructure Article 53 Access between a CSD and another market infrastructure 1. A CCP and a trading venue shall provide transaction feeds on a non-discriminatory and transparent basis to a CSD upon request by the CSD and may charge a reasonable commercial fee for such transaction feeds to the requesting CSD on a cost-plus basis, unless otherwise agreed by both parties. A CSD shall provide access to its securities settlement systems on a non-discriminatory and transparent basis to a CCP or a trading venue and may charge a reasonable commercial fee for such access on a cost-plus basis, unless otherwise agreed by both parties. 2. When a party submits a request for access to another party in accordance with paragraph 1, such request shall be treated promptly and a response to the requesting party shall be provided within three months. 3. The receiving party shall deny access only where such access would affect the smooth and orderly functioning of the financial markets or cause systemic risk. It shall not deny a request on the grounds of loss of market share. A party that refuses access shall provide the requesting party with full written reasons for such refusal based on a comprehensive risk assessment. In the case of a refusal, the requesting party has the right to complain to the competent authority of the party that has refused access. The competent authority of the receiving party and the relevant authority referred to in point (a) of Article 12(1) shall duly examine the complaint by assessing the reasons for refusal and shall provide the requesting party with a reasoned reply. The competent authority of the receiving party shall consult the competent authority of the requesting party and the relevant authority referred to in point (a) of Article 12(1) on its assessment of the complaint. Where any of the authorities of the requesting party disagrees with the assessment provided, any of them may refer the matter to ESMA, which may act in accordance with the powers conferred on it under Article 19 of Regulation (EU) No 1095/2010. Where the refusal by a party to grant access is deemed to be unjustified, the responsible competent authority shall issue an order requiring that party to grant access to its services within three months. 4. ESMA shall, in close cooperation with the members of the ESCB, develop draft regulatory technical standards to specify the risks to be taken into account by CSDs when carrying out a comprehensive risk assessment, and by competent authorities when assessing the reasons for refusal in accordance with paragraph 3, and the elements of the procedure referred to in paragraph 3. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 5. ESMA shall, in close cooperation with the members of the ESCB, develop draft implementing technical standards to establish standard forms and templates for the procedure referred to in paragraphs 2 and 3. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. TITLE IV PROVISION OF BANKING-TYPE ANCILLARY SERVICES FOR CSD PARTICIPANTS Article 54 Authorisation and designation to provide banking-type ancillary services 1. A CSD shall not itself provide any banking-type ancillary services set out in Section C of the Annex unless it has obtained an additional authorisation to provide such services in accordance with this Article. 2. A CSD that intends to settle the cash leg of all or part of its securities settlement system in accordance with Article 40(2) or otherwise wishes to provide any banking-type ancillary services referred to in paragraph 1 shall be authorised either: (a) to offer such services itself under the conditions specified in this Article; or (b) to designate for that purpose one or more credit institutions authorised in accordance with Article 8 of Directive 2013/36/EU. 3. Where a CSD seeks to provide any banking-type ancillary services from within the same legal entity as the legal entity operating the securities settlement system the authorisation referred to in paragraph 2 shall be granted only where the following conditions are met: (a) the CSD is authorised as a credit institution as provided for in Article 8 of Directive 2013/36/EU; (b) the CSD meets the prudential requirements laid down in Article 59(1), (3) and (4) and the supervisory requirements laid down in Article 60; (c) the authorisation referred to in point (a) of this subparagraph is used only to provide the banking-type ancillary services referred to in Section C of the Annex and not to carry out any other activities; (d) the CSD is subject to an additional capital surcharge that reflects the risks, including credit and liquidity risks, resulting from the provision of intra-day credit, inter alia, to the participants in a securities settlement system or other users of CSD services; (e) the CSD reports at least monthly to the competent authority and annually as a part of its public disclosure as required under Part Eight of Regulation (EU) No 575/2013 on the extent and management of intra-day liquidity risk in accordance with point (j) of Article 59(4) of this Regulation; (f) the CSD has submitted to the competent authority an adequate recovery plan to ensure continuity of its critical operations, including in situations where liquidity or credit risk crystallises as a result of the provision of banking-type ancillary services. In the case of conflicting provisions laid down in this Regulation, in Regulation (EU) No 575/2013 and in Directive 2013/36/EU, the CSD referred to in point (a) of the first subparagraph shall comply with the stricter requirements on prudential supervision. The regulatory technical standards referred to in Articles 47 and 59 of this Regulation shall clarify the cases of conflicting provisions. 4. Where a CSD seeks to designate a credit institution to provide any banking-type ancillary services from within a separate legal entity which may be part of the same group of undertakings ultimately controlled by the same parent undertaking or not, the authorisation referred to in paragraph 2 shall be granted only where the following conditions are met: (a) the separate legal entity is authorised as a credit institution as provided for in Article 8 of Directive 2013/36/EU; (b) the separate legal entity meets the prudential requirements laid down in Article 59(1), (3) and (4) and supervisory requirements laid down in Article 60; (c) the separate legal entity does not itself carry out any of the core services referred to in Section A of the Annex; (d) the authorisation referred to in point (a) is used only to provide the banking-type ancillary services referred to in Section C of the Annex and not to carry out any other activities; (e) the separate legal entity is subject to an additional capital surcharge that reflects the risks, including credit and liquidity risks, resulting from the provision of intra-day credit, inter alia, to the participants in a securities settlement system or other users of CSD services; (f) the separate legal entity reports at least monthly to the competent authority and annually as a part of its public disclosure as required under Part Eight of Regulation (EU) No 575/2013 on the extent and management of intra-day liquidity risk in accordance with point (j) of Article 59(4) of this Regulation; and (g) the separate legal entity has submitted to the competent authority an adequate recovery plan to ensure continuity of its critical operations, including in situations where liquidity or credit risk crystallises as a result of the provision of banking-type ancillary services from within a separate legal entity. 5. Paragraph 4 shall not apply to credit institutions referred to in point (b) of paragraph 2 that offer to settle the cash payments for part of the CSD\u2019s securities settlement system, if the total value of such cash settlement through accounts opened with those credit institutions, calculated over a one-year period, is less than one per cent of the total value of all securities transactions against cash settled in the books of the CSD and does not exceed a maximum of EUR 2,5 billion per year. The competent authority shall monitor at least once per year that the threshold defined in the first subparagraph is respected and report its findings to ESMA. Where the competent authority determines that the threshold has been exceeded, it shall require the CSD concerned to seek authorisation in accordance with paragraph 4. The CSD concerned shall submit its application for authorisation within six months. 6. The competent authority may require a CSD to designate more than one credit institution, or to designate a credit institution in addition to providing services itself in accordance with point (a) of paragraph 2 of this Article where it considers that the exposure of one credit institution to the concentration of risks under Article 59(3) and (4) is not sufficiently mitigated. The designated credit institutions shall be considered to be settlement agents. 7. A CSD authorised to provide any banking-type ancillary services and a credit institution designated in accordance with point (b) of paragraph 2 shall comply at all times with the conditions necessary for authorisation under this Regulation and shall, without delay, notify the competent authorities of any substantive changes affecting the conditions for authorisation. 8. EBA shall, in close cooperation with ESMA and the members of the ESCB, develop draft regulatory technical standards to determine the additional risk based capital surcharge referred to in point (d) of paragraph 3 and point (e) of paragraph 4. EBA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 55 Procedure for granting and refusing authorisation to provide banking-type ancillary services 1. The CSD shall submit its application for authorisation to designate a credit institution or to provide any banking-type ancillary service, as required under Article 54, to the competent authority of its home Member State. 2. The application shall contain all the information that is necessary to enable the competent authority to satisfy itself that the CSD and where applicable the designated credit institution have established, at the time of the authorisation, all the necessary arrangements to meet their obligations as laid down in this Regulation. It shall contain a programme of operations setting out the banking-type ancillary services envisaged, the structural organisation of the relations between the CSD and the designated credit institutions where applicable and how that CSD or where applicable the designated credit institution intends to meet the prudential requirements laid down in Article 59(1), (3) and (4) and the other conditions laid down in Article 54. 3. The competent authority shall apply the procedure under Article 17(3) and (8). 4. From the moment when the application is considered to be complete, the competent authority shall transmit all information included in the application to the following authorities: (a) the relevant authorities; (b) the competent authority referred to in point (40) of Article 4(1) of Regulation (EU) No 575/2013; (c) the competent authorities in the Member States where the CSD has established interoperable links with another CSD except where the CSD has established interoperable links referred to in Article 19(5); (d) the competent authorities in the host Member State where the activities of the CSD are of substantial importance for the functioning of the securities markets and the protection of investors within the meaning of Article 24(4); (e) the competent authorities responsible for the supervision of the participants of the CSD that are established in the three Member States with the largest settlement values in the CSD\u2019s securities settlement system on an aggregate basis over a one-year period; (f) ESMA; and (g) EBA. 5. The authorities referred to in points (a) to (e) of paragraph 4 shall issue a reasoned opinion on the authorisation within 30 days of receipt of the information referred to in paragraph 4. Where an authority does not provide an opinion within that deadline it shall be deemed to have a positive opinion. Where at least one of the authorities referred to in points (a) to (e) of paragraph 4 issues a negative reasoned opinion, the competent authority wishing to grant the authorisation shall within 30 days provide the authorities referred to in points (a) to (e) of paragraph 4 with a reasoned decision addressing the negative opinion. Where 30 days after that decision has been presented any of the authorities referred to in points (a) to (e) of paragraph 4 issues a negative opinion and the competent authority still wishes to grant the authorisation any of the authorities that issued a negative opinion may refer the matter to ESMA for assistance under point (c) of Article 31 of Regulation (EU) No 1095/2010. Where 30 days after referral to ESMA the issue is not settled, the competent authority wishing to grant the authorisation shall take the final decision and provide a detailed explanation of its decision in writing to the authorities referred to in points (a) to (e) of paragraph 4. Where the competent authority wishes to refuse authorisation, the matter shall not be referred to ESMA. Negative opinions shall state in writing the full and detailed reasons why the requirements laid down in this Regulation or other parts of Union law are not met. 6. Where ESMA considers that the competent authority referred to in paragraph 1 has granted an authorisation which may not be in conformity with Union law it shall act in accordance with Article 17 of Regulation (EU) No 1095/2010. 7. ESMA shall, in close cooperation with the members of the ESCB and EBA, develop draft regulatory technical standards to specify the information that the CSD is to provide to the competent authority for the purpose of obtaining the relevant authorisations to provide the banking-type services ancillary to settlement. ESMA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 8. ESMA shall, in close cooperation with the members of the ESCB and EBA, develop draft implementing technical standards to establish standard forms, templates and procedures for the consultation of the authorities referred to in paragraph 4 prior to granting authorisation. ESMA shall submit those draft implementing technical standards to the Commission by 18 June 2015. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010. Article 56 Extension of the banking-type ancillary services 1. A CSD that intends to extend the banking-type ancillary services for which it designates a credit institution or that it provides itself in accordance with Article 54, shall submit a request for extension to the competent authority of its home Member State. 2. The request for extension shall be subject to the procedure under Article 55. Article 57 Withdrawal of authorisation 1. Without prejudice to any remedial actions or measures under Title V, the competent authority of the CSD\u2019s home Member State shall withdraw the authorisations referred to in Article 54 in any of the following circumstances: (a) where the CSD has not made use of the authorisation within 12 months, expressly renounces the authorisation or where the designated credit institution has provided no services or performed no activity for the preceding six months; (b) where the CSD has obtained the authorisation by making false statements or by any other unlawful means; (c) where the CSD or the designated credit institution is no longer in compliance with the conditions under which authorisation was granted and has not taken the remedial actions requested by the competent authority within a set time-frame; (d) where the CSD or the designated credit institution has seriously and systematically infringed the requirements laid down in this Regulation. 2. From the moment when it becomes aware of one of the circumstances referred to in paragraph 1, the competent authority shall immediately consult the authorities referred to in Article 55(4) on the necessity of withdrawing the authorisation. 3. ESMA, any relevant authority under point (a) of Article 12(1) and any authority referred to in Article 60(1) or, respectively, the authorities referred to in Article 55(4) may, at any time, request that the competent authority of the CSD\u2019s home Member State examine whether the CSD and where applicable the designated credit institution is still in compliance with the conditions under which the authorisation is granted. 4. The competent authority may limit the withdrawal to a particular service, activity, or financial instrument. 5. A CSD and the designated credit institution shall establish, implement and maintain an adequate procedure ensuring the timely and orderly settlement and transfer of the assets of clients and participants to another settlement agent in the event of a withdrawal of authorisation referred to in paragraph 1. Article 58 CSD register 1. Decisions taken by competent authorities under Articles 54, 56 and 57 shall be notified to ESMA. 2. ESMA shall introduce in the register, that it is required to make available on its dedicated website in accordance with Article 21(3), the following information: (a) the name of each CSD which was subject to a decision under Articles 54, 56 and 57; (b) the name of each designated credit institution; (c) the list of banking-type ancillary services that a designated credit institution or a CSD authorised under Article 54 is authorised to provide for the CSD\u2019s participants. 3. The competent authorities shall notify to ESMA those entities that provide banking-type ancillary services according to requirements of national law by 16 December 2014. Article 59 Prudential requirements applicable to credit institutions or CSDs authorised to provide banking-type ancillary services 1. A credit institution designated under point (b) of Article 54(2) or a CSD authorised under point (a) of Article 54(2) to provide banking-type ancillary services shall provide only the services set out in Section C of the Annex that are covered by the authorisation. 2. A credit institution designated under point (b) of Article 54(2) or a CSD authorised under point (a) of Article 54(2) to provide banking-type ancillary services shall comply with any present or future legislation applicable to credit institutions. 3. A credit institution designated under point (b) of Article 54(2) or a CSD authorised under point (a) of Article 54(2) to provide banking-type ancillary services shall comply with the following specific prudential requirements for the credit risks related to those services in respect of each securities settlement system: (a) it shall establish a robust framework to manage the corresponding credit risks; (b) it shall identify the sources of such credit risks, frequently and regularly, measure and monitor corresponding credit exposures and use appropriate risk-management tools to control those risks; (c) it shall fully cover corresponding credit exposures to individual borrowing participants using collateral and other equivalent financial resources; (d) if collateral is used to manage its corresponding credit risk, it shall accept highly liquid collateral with minimal credit and market risk; it may use other types of collateral in specific situations if an appropriate haircut is applied; (e) it shall establish and apply appropriately conservative haircuts and concentration limits on collateral values constituted to cover the credit exposures referred to in point (c), taking into account the objective of ensuring that collateral can be liquidated promptly without significant adverse price effects; (f) it shall set limits on its corresponding credit exposures; (g) it shall analyse and plan for how to address any potential residual credit exposures, and adopt rules and procedures to implement such plans; (h) it shall provide credit only to participants that have cash accounts with it; (i) it shall provide for effective reimbursement procedures of intra-day credit and discourage overnight credit through the application of sanctioning rates which act as an effective deterrent. 4. A credit institution designated under point (b) of Article 54(2) or a CSD authorised under point (a) of Article 54(2) to provide banking-type ancillary services shall comply with the following specific prudential requirements for the liquidity risks relating to those services in respect of each securities settlement system: (a) it shall have a robust framework and tools to measure, monitor, and manage its liquidity risks, including intra-day liquidity risks, for each currency of the security settlement system for which it acts as settlement agent; (b) it shall measure and monitor on an ongoing and timely basis, and at least daily, its liquidity needs and the level of liquid assets it holds; in doing so, it shall determine the value of its available liquid assets taking into account appropriate haircuts on those assets; (c) it shall have sufficient liquid resources in all relevant currencies for a timely provision of settlement services under a wide range of potential stress scenarios including, but not limited to the liquidity risk generated by the default of at least one participant, including its parent undertakings and subsidiaries, to which it has the largest exposures; (d) it shall mitigate the corresponding liquidity risks with qualifying liquid resources in each currency such as cash at the central bank of issue and at other creditworthy financial institutions, committed lines of credit or similar arrangements and highly liquid collateral or investments that are readily available and convertible into cash with prearranged and highly reliable funding arrangements, even in extreme but plausible market conditions and it shall identify, measure and monitor its liquidity risk stemming from the various financial institutions used for the management of its liquidity risks; (e) where prearranged funding arrangements are used, it shall select only creditworthy financial institutions as liquidity providers; it shall establish and apply appropriate concentration limits for each of the corresponding liquidity providers including its parent undertaking and subsidiaries; (f) it shall determine and test the sufficiency of the corresponding resources by regular and rigorous stress testing; (g) it shall analyse and plan for how to address any unforeseen and potentially uncovered liquidity shortfalls, and adopt rules and procedures to implement such plans; (h) where practical and available, without prejudice to the eligibility rules of the central bank, it shall have access to central bank accounts and other central bank services to enhance its management of liquidity risks and Union credit institutions shall deposit the corresponding cash balances on dedicated accounts with Union central banks of issue; (i) it shall have prearranged and highly reliable arrangements to ensure that it can liquidate in a timely fashion the collateral provided to it by a defaulting client; (j) it shall report regularly to the authorities referred to in Article 60(1), and disclose to the public, as to how it measures, monitors and manages its liquidity risks, including intra-day liquidity risks. 5. EBA shall, in close cooperation with ESMA and the members of the ESCB, develop draft regulatory technical standards to further specify details of the frameworks and tools for the monitoring, the measuring, the management, the reporting and the public disclosure of the credit and liquidity risks, including those which occur intra-day, referred to in paragraphs 3 and 4. Such draft regulatory technical standards shall, where appropriate, be aligned to the regulatory technical standards adopted in accordance with Article 46(3) of Regulation (EU) No 648/2012. EBA shall submit those draft regulatory technical standards to the Commission by 18 June 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. Article 60 Supervision of designated credit institutions and CSDs authorised to provide banking-type ancillary services 1. Without prejudice to Articles 17 and 22 of this Regulation, the competent authorities referred to in point (40) of Article 4(1) of Regulation (EU) No 575/2013 are responsible for the authorisation as credit institutions and supervision as credit institutions under the conditions provided in Regulation (EU) No 575/2013 and in Directive 2013/36/EU of the designated credit institutions and CSDs authorised under this Regulation to provide banking-type ancillary services. The competent authorities referred to in the first subparagraph shall also be responsible for the supervision of designated credit institutions and CSDs referred to in that subparagraph as regards their compliance with the prudential requirements referred to in Article 59 of this Regulation. The competent authorities referred to in the first subparagraph shall regularly, and at least once a year, assess whether the designated credit institution or CSD authorised to provide banking-type ancillary services complies with Article 59 and shall inform the competent authority of the CSD which shall then inform the authorities referred to in Article 55(4), of the results, including any remedial actions or penalties, of its supervision under this paragraph. 2. The competent authority of the CSD shall, after consulting competent authorities referred to paragraph 1, review and evaluate at least on an annual basis the following: (a) in the case referred to in point (b) of Article 54(2), whether all the necessary arrangements between the designated credit institutions and the CSD allow them to meet their obligations as laid down in this Regulation; (b) in the case referred to in point (a) of Article 54(2), whether the arrangements relating to the authorisation to provide banking-type ancillary services allow the CSD to meet its obligations as laid down in this Regulation. The competent authority of the CSD shall regularly, and at least once a year, inform the authorities referred to in Article 55(4) of the results, including any remedial actions or penalties, of its review and evaluation under this paragraph. Where a CSD designates an authorised credit institution in accordance with Article 54, in view of the protection of the participants in the securities settlement systems it operates, a CSD shall ensure that it has access from the credit institution it designates to all necessary information for the purpose of this Regulation and it shall report any infringements thereof to the competent authority of the CSD and to competent authorities referred to in paragraph 1. 3. In order to ensure consistent, efficient and effective supervision within the Union of credit institutions and CSDs authorised to provide banking-type ancillary services, EBA may, in close cooperation with ESMA and the members of the ESCB, issue guidelines addressed to competent authorities in accordance with Article 16 of Regulation (EU) No 1093/2010. TITLE V SANCTIONS Article 61 Administrative sanctions and other measures 1. Without prejudice to the right of Member States to provide for and impose criminal sanctions, Member States shall lay down rules on and ensure that their competent authorities may impose the administrative sanctions and other measures applicable in the circumstances defined in Article 63 to the persons responsible for infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. Such sanctions and other measures shall be effective, proportionate and dissuasive. Member States may decide not to lay down rules for administrative sanctions as referred to in the first subparagraph where the infringements referred to in that subparagraph are already subject to criminal sanctions in their national law by 18 September 2016. Where they so decide, Member States shall notify, in detail, to the Commission and to ESMA, the relevant parts of their criminal law. By 18 September 2016, the Member States shall notify the rules referred to in the first subparagraph to the Commission and ESMA. Member States shall notify the Commission and ESMA without undue delay of any subsequent amendments thereto. 2. The competent authorities shall be able to apply administrative sanctions and other measures, to CSDs, designated credit institutions, and, subject to the conditions laid down in national law in areas not harmonised by this Regulation, the members of their management bodies and any other persons who effectively control their business as well as to any other legal or natural person who under national law is held responsible for an infringement. 3. In the exercise of their sanctioning powers in the circumstances defined in Article 63 competent authorities shall cooperate closely to ensure that the administrative sanctions and other measures produce the results pursued by this Regulation and coordinate their actions in order to avoid any duplication or overlap when applying administrative sanctions and other measures to cross border cases in accordance with Article 14. 4. Where Member States have chosen, in accordance with paragraph 1 to lay down criminal sanctions for the infringements of the provisions referred to in Article 63, they shall ensure that appropriate measures are in place so that competent authorities have all the necessary powers to liaise with judicial authorities within their jurisdiction to receive specific information related to criminal investigations or proceedings commenced for possible infringements of this Regulation and provide the same to other competent authorities and ESMA to fulfil their obligation to cooperate with each other and ESMA for the purposes of this Regulation. 5. Competent authorities may also cooperate with competent authorities of other Member States with respect to facilitating the recovery of pecuniary sanctions. 6. Member States shall provide ESMA annually with aggregated information regarding all sanctions and other measures imposed in accordance with paragraph 1. ESMA shall publish that information in an annual report. Where Member States have chosen, in accordance with paragraph 1, to lay down criminal sanctions for the infringements of the provisions referred to in Article 63 their competent authorities shall provide ESMA annually with anonymised and aggregated data regarding all criminal investigations undertaken and criminal penalties imposed. ESMA shall publish data on criminal sanctions imposed in an annual report. 7. Where the competent authority has disclosed an administrative sanction or an administrative measure or a criminal sanction to the public, it shall, at the same time, report that fact to ESMA. 8. Competent authorities shall exercise their functions and powers in accordance with their national frameworks: (a) directly; (b) in collaboration with other authorities; (c) under their responsibility by delegation to entities to which tasks have been delegated according to this Regulation; or (d) by application to the competent judicial authorities. Article 62 Publication of decisions 1. Member States shall ensure that the competent authorities publish on their official websites any decision imposing an administrative sanction or other measure for an infringement of this Regulation without undue delay after the person sanctioned is informed of that decision. The publication shall include at least information on the type and nature of the infringement and the identity of a natural or legal person on whom the sanction has been imposed. Where the decision to impose a sanction or other measure is subject to an appeal before the relevant judicial or other relevant authorities, competent authorities shall, without undue delay, also publish on their official websites information on the appeal status and outcome thereof. Moreover, any decision annulling a previous decision to impose a sanction or a measure shall also be published. Where the publication of the identity of the legal persons or of the personal data of the natural persons is considered by the competent authority to be disproportionate following a case-by-case assessment conducted on the proportionality of the publication of such data, or where publication jeopardises the stability of financial markets or an ongoing investigation, Member States shall ensure that competent authorities do one of the following: (a) delay the publication of the decision to impose the sanction or other measure until the moment when the reasons for non-publication cease to exist; (b) publish the decision to impose the sanction or other measure on an anonymous basis in a manner which is in conformity with national law, if such anonymous publication ensures effective protection of the personal data; (c) not publish the decision to impose a sanction or other measure at all in the event that the options set out in points (a) and (b) above are considered to be insufficient to ensure: (i) that the stability of financial markets would not be put in jeopardy; (ii) the proportionality of the publication of such decisions with regard to measures which are deemed to be of a minor nature. In the case of a decision to publish a sanction or other measure on an anonymous basis, the publication of the relevant data may be postponed for a reasonable period if it is envisaged that within that period the reasons for anonymous publication will cease to exist. Competent authorities shall inform ESMA of all administrative sanctions imposed but not published in accordance with point (c) of the third subparagraph including any appeal in relation thereto and the outcome thereof. Member States shall ensure that competent authorities receive information and the final judgement in relation to any criminal sanction imposed and submit it to ESMA. ESMA shall maintain a central database of sanctions communicated to it solely for the purposes of exchanging information between competent authorities. That database shall be accessible only to competent authorities and it shall be updated on the basis of the information provided by the competent authorities. 2. Competent authorities shall ensure that any publication, in accordance with this Article, shall remain on their official website for a period of at least five years after its publication. Personal data contained in the publication shall be kept on the official website of the competent authority only for the period necessary under the applicable data protection rules. Article 63 Sanctions for infringements 1. This Article shall apply to the following provisions of this Regulation: (a) provision of services set out in Sections A, B and C of the Annex in infringement of Articles 16, 25 and 54; (b) obtaining the authorisations required under Articles 16 and 54 by making false statements or by any other unlawful means as provided for in point (b) of Article 20(1) and point (b) of Article 57(1); (c) failure of CSDs to hold the required capital, thus infringing Article 47(1); (d) failure of CSDs to comply with the organisational requirements, thus infringing Articles 26 to 30; (e) failure of CSDs to comply with the conduct of business rules, thus infringing Articles 32 to 35; (f) failure of CSDs to comply with the requirements for CSD services, thus infringing Articles 37 to 41; (g) failure of CSDs to comply with the prudential requirements, thus infringing Articles 43 to 47; (h) failure of CSDs to comply with the requirements for CSD links, thus infringing Article 48; (i) abusive refusals by CSDs to grant different types of access, thus infringing Articles 49 to 53; (j) failure of designated credit institutions to comply with the specific prudential requirements related to credit risks, thus infringing Article 59(3); (k) failure of designated credit institutions to comply with specific prudential requirements related to liquidity risks, thus infringing Article 59(4). 2. Without prejudice to the supervisory powers of competent authorities, at least in the event of an infringement referred to in this Article, the competent authorities shall, in conformity with national law, have the power to impose at least the following administrative sanctions and other measures: (a) a public statement which indicates the person responsible for the infringement and the nature of the infringement in accordance with Article 62; (b) an order requiring the person responsible for the infringement to cease the conduct and to desist from a repetition of that conduct; (c) withdrawal of the authorisations granted under Article 16 or 54, in accordance with Article 20 or 57; (d) a temporary or, for repeated serious infringements, a permanent ban against any member of the institution\u2019s management body or any other natural person, who is held responsible, from exercising management functions in the institution; (e) maximum administrative pecuniary sanctions of at least twice the amounts of the profit gained as a result of an infringement where those amounts can be determined; (f) in respect of a natural person, maximum administrative pecuniary sanctions of at least EUR 5 million or in the Member States whose currency is not the euro, the corresponding value in the national currency on the date of adoption of this Regulation; (g) in the case of a legal person, maximum administrative pecuniary sanctions of at least EUR 20 million or up to 10 % of the total annual turnover of the legal person according to the last available accounts approved by the management body; where the legal person is a parent undertaking or a subsidiary of the parent undertaking which has to prepare consolidated financial accounts according to Directive 2013/34/EU, the relevant total annual turnover shall be the total annual turnover or the corresponding type of income according to the relevant Accounting Directives according to the last available consolidated accounts approved by the management body of the ultimate parent undertaking. 3. Competent authorities may have other sanctioning powers in addition to those referred in paragraph 2 and may provide for higher levels of administrative pecuniary sanctions than those established in that paragraph. Article 64 Effective application of sanctions Member States shall ensure that, when determining the type and level of administrative sanctions or other measures, the competent authorities take into account all relevant circumstances, including, where appropriate: (a) the gravity and the duration of the infringement; (b) the degree of responsibility of the person responsible for the infringement; (c) the financial strength of the person responsible for the infringement, for example as indicated by the total turnover of the responsible legal person or the annual income of the responsible natural person; (d) the importance of the profits gained, losses avoided by the person responsible for the infringement or the losses for third parties derived from the infringement, insofar as they can be determined; (e) the level of cooperation of the person responsible for the infringement with the competent authority, without prejudice to the need to ensure disgorgement of profits gained or losses avoided by that person; (f) previous infringements by the person responsible for the infringement. Article 65 Reporting of infringements 1. Member States shall ensure that competent authorities establish effective mechanisms to encourage reporting of potential or actual infringements of this Regulation to competent authorities. 2. The mechanisms referred to in paragraph 1 shall include at least: (a) specific procedures for the receipt and investigation of reports on potential or actual infringements and their follow-up, including the establishment of secure communication channels for such reports; (b) appropriate protection for employees of institutions who report potential or actual infringements committed within the institution against retaliation, discrimination or other types of unfair treatment at a minimum; (c) protection of personal data concerning both the person who reports the potential or actual infringements and the natural person who is allegedly responsible for an infringement in compliance with the principles laid down in Directive 95/46/EC; (d) protection of the identity of both the person who reports the infringements and the natural person who is allegedly responsible for an infringement, at all stages of the procedures unless such disclosure is required by national law in the context of further investigation or subsequent administrative or judicial proceedings. 3. Member States shall require institutions to have in place appropriate procedures for their employees to report actual or potential infringements internally through a specific, independent and autonomous channel. Such a channel may also be provided through arrangements provided for by social partners. The same protection as is referred to in points (b), (c) and (d) of paragraph 2 shall apply. Article 66 Right of appeal Member States shall ensure that decisions and measures taken in pursuance of this Regulation are properly reasoned and subject to a right of appeal before a tribunal. The right of appeal before a tribunal shall apply where no decision is taken, within six months of its submission, in respect of an application for authorisation which contains all the information required under the provisions in force. TITLE VI DELEGATION OF POWER, IMPLEMENTING POWERS, TRANSITIONAL, AMENDING AND FINAL PROVISIONS Article 67 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 2(2), Article 7(14) and Article 24(7) shall be conferred on the Commission for an indeterminate period of time from 17 September 2014. 3. The delegation of power referred to in Article 2(2), Article 7(14) and Article 24(7) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 2(2), Article 7(14) and Article 24(7) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 68 Committee procedure 1. The Commission shall be assisted by the European Securities Committee established by Commission Decision 2001/528/EC (27). That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 69 Transitional provisions 1. The competent authorities shall communicate to ESMA those institutions that operate as CSDs by 16 December 2014. 2. CSDs shall apply for all authorisations that are necessary for the purposes of this Regulation and shall notify the relevant CSD links within six months from the date of entry into force of all the regulatory technical standards adopted under Articles 17, 26, 45, 47, 48, and, where relevant, Articles 55 and 59. 3. Within six months from the later of the date of entry into force of the regulatory technical standards adopted under Articles 12, 17, 25, 26, 45, 47, 48, and, where relevant, Articles 55 and 59 or the implementing decision referred to in Article 25(9), a third-country CSD shall apply for recognition from ESMA where it intends to provide its services on the basis of Article 25. 4. Until the decision is made under this Regulation on the authorisation or recognition of CSDs and of their activities, including CSD links, the respective national rules on authorisation and recognition of CSDs shall continue to apply. 5. CSDs operated by the entities referred to in Article 1(4) shall comply with the requirements of this Regulation at the latest within one year from the date of entry into force of the regulatory technical standards referred to in paragraph 2. Article 70 Amendments to Directive 98/26/EC Directive 98/26/EC is amended as follows: (1) the third indent of the first subparagraph of point (a) of Article 2 is replaced by the following: \u2018\u2014 designated, without prejudice to other more stringent conditions of general application laid down by national law, as a system and notified to the European Securities and Markets Authority by the Member State whose law is applicable, after that Member State is satisfied as to the adequacy of the rules of the system.\u2019; (2) in Article 11, the following paragraph is added: \u20183. By 18 March 2015, Member States shall adopt and publish and communicate to the Commission measures necessary to comply with the third indent of the first subparagraph of point (a) of Article 2.\u2019. Article 71 Amendments to Directive 2014/65/EU Directive 2014/65/EU is amended as follows: (1) in Article 2(1), point (o) is replaced by the following: \u2018(o) CSDs except as provided for in Article 73 of Regulation (EU) No 909/2014 of the European Parliament and of the Council (28). (28) Regulation (EU) No 909/2014 of the European Parliament and of the Council of 23 July 2014 on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012 (OJ L 257, 28.8.2014, p. 1).\u2019;\" (2) in Article 4(1), the following point is added: \u2018(64) \u2018central securities depository\u2019 or \u2018CSD\u2019 means a central securities depository as defined in point (1) of Article 2(1) of Regulation (EU) No 909/2014.\u2019; (3) in Section B of Annex I, point (1) is replaced by the following: \u2018(1) Safekeeping and administration of financial instruments for the account of clients, including custodianship and related services such as cash/collateral management and excluding providing and maintaining securities accounts at the top tier level (\u2018central maintenance service\u2019) referred to in point (2) of Section A of the Annex to the Regulation (EU) No 909/2014.\u2019. Article 72 Amendment to Regulation (EU) No 236/2012 Article 15 of Regulation (EU) No 236/2012 is deleted. Article 73 Application of Directive 2014/65/EU and Regulation (EU) No 600/2014 CSDs authorised in accordance with Article 16 of this Regulation shall not require authorisation under Directive 2014/65/EU in order to provide the services explicitly listed in Sections A and B of the Annex to this Regulation. Where a CSD authorised in accordance with Article 16 of this Regulation provides one or more investment services or carries out one or more investment activities in addition to providing the services explicitly listed in Sections A and B of the Annex to this Regulation, Directive 2014/65/EU with the exception of Articles 5 to 8, Article 9(1) to (2) and (4) to (6) and Articles 10 to 13, and Regulation (EU) No 600/2014 shall apply. Article 74 Reports 1. ESMA shall, in cooperation with EBA and the competent authorities and the relevant authorities, submit annual reports to the Commission providing assessments of trends, potential risks and vulnerabilities, and, where necessary, recommendations of preventative or remedial action in the markets for services covered by this Regulation. Those reports shall include at least an assessment of the following: (a) settlement efficiency for domestic and cross-border operations for each Member State based on the number and volume of settlement fails, amount of penalties referred to in Article 7(2), number and volumes of buy-in transactions referred to in Article 7(3) and (4) and any other relevant criteria; (b) the appropriateness of penalties for settlement fails, in particular the need for additional flexibility in relation to penalties for settlement fails in relation to illiquid financial instruments referred to in Article 7(4); (c) measuring settlement which does not take place in the securities settlement systems operated by CSDs based on the number and volume of transactions based on the information received under Article 9 and any other relevant criteria; (d) the cross-border provision of services covered by this Regulation based on the number and types of CSD links, number of foreign participants in the securities settlement systems operated by CSDs, number and volume of transactions involving such participants, number of foreign issuers recording their securities in a CSD in accordance with Article 49 and any other relevant criteria; (e) the handling of access requests in Articles 49, 52 and 53 to identify the reasons for rejection of access requests by CSDs, CCPs and trading venues any trends in such rejections and ways in which the risks identified could be mitigated in future so as to allow for access to be granted, and any other substantive barriers to competition in post-trade financial services; (f) the handling of applications submitted in accordance with the procedures referred to in Article 23(3) to (7) and Article 25(4) to (10); (g) where applicable, the findings of the peer review process for cross-border supervision in Article 24(6) and whether the frequency of such reviews could be reduced in the future, including an indication of whether such findings indicate the need for more formal colleges of supervisors; (h) the application of civil liability rules of Member States relating to the losses attributable to CSDs; (i) the procedures and conditions under which CSDs have been authorised to designate credit institutions or themselves to provide banking-type ancillary services in accordance with Articles 54 and 55, including an assessment of the effects that such provision may have on financial stability and competition for settlement and banking-types ancillary services in the Union; (j) the application of the rules referred to in Article 38 on protection of securities of participants and those of their clients, in particular those in Article 38(5); (k) the application of the sanctions and in particular the need to further harmonise the administrative sanctions for the infringement of the requirements laid down in this Regulation. 2. The reports referred to in paragraph 1 covering a calendar year shall be communicated to the Commission by 30 April of the following calendar year. Article 75 Review By 18 September 2019, the Commission shall review and prepare a general report on this Regulation. That report shall, in particular, assess the matters referred to in points (a) to (k) of Article 74(1), whether there are other substantive barriers to competition in relation to the services subject to this Regulation which are insufficiently addressed and the potential need for further measures to limit the impact on taxpayers of the failure of CSDs. The Commission shall submit the report to the European Parliament and to the Council, together with any appropriate proposals. Article 76 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. Article 3(1) shall apply from 1 January 2023 to transferable securities issued after that date and from 1 January 2025 to all transferable securities. 3. Article 5(2) shall apply from 1 January 2015. By way of derogation from the first subparagraph of this paragraph, in the case of a trading venue that has access to a CSD referred to in Article 30(5), Article 5(2) shall apply at least six months before such a CSD outsources its activities to the relevant public entity, and in any event from 1 January 2016. 4. The settlement discipline measures referred to in Article 6(1) to (4) shall apply from the date of entry into force of the delegated act adopted by the Commission pursuant to Article 6(5). 5. The settlement discipline measures referred to in Article 7(1) to (13) and the amendment laid down in Article 72 shall apply from the date of entry into force of the delegated act adopted by the Commission pursuant to Article 7(15). An MTF that complies with the criteria laid down in Article 33(3) of Directive 2014/65/EU shall be subject to the second subparagraph of Article 7(3) of this Regulation: (a) until the final determination of its application for registration under Article 33 of Directive 2014/65/EU; or (b) where an MTF has not applied for registration under Article 33 of Directive 2014/65/EU, until 13 June 2017. 6. The reporting measures referred to in Article 9(1) shall apply from the date of entry into force of the implementing act adopted by the Commission pursuant to Article 9(3). 7. References in this Regulation to Directive 2014/65/EU and Regulation (EU) No 600/2014 shall, before 3 January 2017, be read as references to Directive 2004/39/EC in accordance with the correlation table set out in Annex IV to Directive 2014/65/EU in so far as that correlation table contains provisions referring to Directive 2004/39/EC. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 23 July 2014. For the European Parliament The President M. SCHULZ For the Council The President S. GOZI (1) OJ C 310, 13.10.2012, p. 12. (2) OJ C 299, 4.10.2012, p. 76. (3) Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of 23 July 2014. (4) Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (OJ L 166, 11.6.1998, p. 45). (5) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (6) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32). (7) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349). (8) Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84). (9) Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (OJ L 168, 27.6.2002, p. 43). (10) Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1). (11) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190). (12) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19). (13) [2004] ECR I-4829. (14) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338). (15) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (16) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12). (17) Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63). (18) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (19) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (20) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission\u2019s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (21) Directive 2010/78/EU of the European Parliament and of the Council of 24 November 2010 amending Directives 98/26/EC, 2002/87/EC, 2003/6/EC, 2003/41/EC, 2003/71/EC, 2004/39/EC, 2004/109/EC, 2005/60/EC, 2006/48/EC, 2006/49/EC and 2009/65/EC in respect of the powers of the European Supervisory Authority (European Banking Authority), the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) (OJ L 331, 15.12.2010, p. 120). (22) Regulation (EU) No 236/2012 of the European Parliament and of the Council of 14 March 2012 on short selling and certain aspects of credit default swaps (OJ L 86, 24.3.2012, p. 1). (23) Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading and amending Directive 2001/34/EC (OJ L 345, 31.12.2003, p. 64). (24) Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (OJ L 331, 15.12.2010, p. 1). (25) Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (OJ L 309, 25.11.2005, p. 15). (26) Commission Directive 2006/70/EC of 1 August 2006 laying down implementing measures for Directive 2005/60/EC of the European Parliament and of the Council as regards the definition of politically exposed person and the technical criteria for simplified customer due diligence procedures and for exemption on grounds of a financial activity conducted on an occasional or very limited basis (OJ L 214, 4.8.2006, p. 29). (27) Commission Decision 2001/528/EC of 6 June 2001 establishing the European Securities Committee (OJ L 191, 13.7.2001, p. 45). ANNEX LIST OF SERVICES SECTION A Core services of central securities depositories 1. Initial recording of securities in a book-entry system (\u2018notary service\u2019); 2. Providing and maintaining securities accounts at the top tier level (\u2018central maintenance service\u2019); 3. Operating a securities settlement system (\u2018settlement service\u2019). SECTION B Non-banking-type ancillary services of CSDs that do not entail credit or liquidity risks Services provided by CSDs that contribute to enhancing the safety, efficiency and transparency of the securities markets, which may include but are not restricted to: 1. Services related to the settlement service, such as: (a) Organising a securities lending mechanism, as agent among participants of a securities settlement system; (b) Providing collateral management services, as agent for participants in a securities settlement system; (c) Settlement matching, instruction routing, trade confirmation, trade verification. 2. Services related to the notary and central maintenance services, such as: (a) Services related to shareholders\u2019 registers; (b) Supporting the processing of corporate actions, including tax, general meetings and information services; (c) New issue services, including allocation and management of ISIN codes and similar codes; (d) Instruction routing and processing, fee collection and processing and related reporting. 3. Establishing CSD links, providing, maintaining or operating securities accounts in relation to the settlement service, collateral management, other ancillary services. 4. Any other services, such as: (a) Providing general collateral management services as agent; (b) Providing regulatory reporting; (c) Providing information, data and statistics to market/census bureaus or other governmental or inter-governmental entities; (d) Providing IT services. SECTION C Banking-type ancillary services Banking-type services directly related to core or ancillary services listed in Sections A and B, such as: (a) Providing cash accounts to, and accepting deposits from, participants in a securities settlement system and holders of securities accounts, within the meaning of point 1 of Annex I to Directive 2013/36/EU; (b) Providing cash credit for reimbursement no later than the following business day, cash lending to pre-finance corporate actions and lending securities to holders of securities accounts, within the meaning of point 2 of Annex I to Directive 2013/36/EU; (c) Payment services involving processing of cash and foreign exchange transactions, within the meaning of point 4 of Annex I to Directive 2013/36/EU; (d) Guarantees and commitments related to securities lending and borrowing, within the meaning of point 6 of Annex I to Directive 2013/36/EU; (e) Treasury activities involving foreign exchange and transferable securities related to managing participants\u2019 long balances, within the meaning of points 7(b) and (e) of Annex I to Directive 2013/36/EU.", "summary": "Improving securities settlement in the EU Improving securities settlement in the EU SUMMARY OF: Regulation (EU) No 909/2014 on improving securities settlement in the European Union and on central securities depositories WHAT IS THE AIM OF THE REGULATION? It aims to harmonise the timing and conduct of securities settlement in the European Union (EU) and the rules applicable to central securities depositories (CSDs)*. It is designed to increase the safety and efficiency of the system, particularly for transactions within the EU. KEY POINTS The regulation notably introduces the following elements. Shorter settlement periods, which should in general take place no later than the second business day after the trading occurs.An obligation to record in book-entry form* all transferable securities admitted to trading or traded on the trading venues.Strict organisational, conduct of business and prudential requirements for CSDs.A settlement discipline regime to deal with settlement failures. CSDs must operate a cash penalties system and are subject to reporting requirements regarding settlement failures. Participants are subject to mandatory buy-ins.A passport system allowing authorised CSDs to provide their services across the EU, subject to certain passporting requirements.Increased prudential and supervisory requirements for CSDs and other institutions providing banking-type services that support securities settlement. EU Member States\u2019 national authorities: authorise and supervise CSDs, and review and evaluate them on an annual basis at least;exchange information and cooperate with each other and the European Securities and Markets Authority (ESMA). CSDs must notably: have robust governance arrangements, a clear organisational structure, internal controls and sound administrative and accounting procedures;ensure senior management is of sufficiently good repute and experience;establish user committees for each securities settlement system they operate;maintain for at least 10 years all records of their services and activities;remain fully responsible for any work they outsource;display transparency by publicly disclosing the prices and fees involved in the core services they provide;have sufficient capital to be adequately protected against operational, legal, custody, investment and business risks;secure additional authorisations before providing any banking-type ancillary services. CSDs in a non-EU country may operate in the EU, including through an EU-based branch, provided they meet certain requirements. ESMA maintains a publicly available register of each authorised CSD. Member States\u2019 competent authorities have the power to apply appropriate administrative sanctions and other measures for an infringement. Amendments to Regulation (EU) No 909/2014 To have a clear and coherent legislative framework for trading and settlement, Regulation (EU) No 909/2014 relies on many of the definitions and concepts of Directive 2014/65/EU (MiFID II \u2013 see summary). Regulation (EU) 2016/1033 amends Regulation (EU) No 909/2014 to take into account the change in the date of application of MiFID II. To ensure legal certainty for the period between the previous date of application and the new date of application of MiFID II, Regulation (EU) 2016/1033 amends Regulation (EU) No 909/2014 clarifying that the rules set out in MiFID I (Directive 2004/39/EC) apply until the new date of entry into application of MiFID II. The European Commission has also adopted several delegated acts supplementing Regulation (EU) No 909/2014: Delegated Regulation (EU) 2017/389 regarding the parameters for the calculation of cash penalties for settlement fails and the operations of CSDs in host Member States;Delegated Regulation (EU) 2017/390 with regard to regulatory technical standards on certain prudential requirements for central securities depositories and designated credit institutions offering banking-type ancillary services;Delegated Regulation (EU) 2017/391 with regard to regulatory technical standards further specifying the content of the reporting on internalised settlements;Delegated Regulation (EU) 2017/392 with regard to regulatory technical standards on authorisation, supervisory and operational requirements for central securities depositories;Delegated Regulation (EU) 2018/1229 with regard to regulatory technical standards on settlement discipline, which has in turn been amended by Delegated Regulation (EU) 2020/1212 and Delegated Regulation (EU) 2021/70. FROM WHEN DOES THE REGULATION APPLY? Book-entry form requirements (Article 3(1)) apply from 1 January 2023 to transferable securities issued after that date and from 1 January 2025 to all transferable securities. The regulation\u2019s settlement date rules (Article 5(2)) have applied since 1 January 2015. The settlement discipline regime (Articles 6(1) to (4) and 7(1) to (13)) applies from 1 February 2022. BACKGROUND Traditionally, CSDs have been regulated nationally. Settlement across borders presents higher risks and costs for investors than domestic operations. At the same time, this form of transaction is increasing. The main objective of the regulation is to increase the safety and efficiency of securities settlement and settlement infrastructures in the EU. It does this by providing a common set of prudential, organisational and conduct of business standards for use across the EU, which should play a crucial role in financing the economy. For further information, see: Central securities depositories (CSDs) (European Commission)Settlement (European Securities and Markets Authority). KEY TERMS Central securities depositories. A legal person that operates a securities settlement system and provides at least services for the initial recording of securities in a book-entry system and/or for the provision and maintenance of securities accounts at top tier level. Book entry. Where the ownership of a security is recorded in electronic form rather than in certificate form. MAIN DOCUMENT Regulation (EU) No 909/2014 of the European Parliament and of the Council of 23 July 2014 on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012 OJ L 257, 28.8.2014, pp. 1\u201372). Successive amendments to Regulation (EU) No 909/2014 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2018/1229 of 25 May 2018 supplementing Regulation (EU) No 909/2014 of the European Parliament and of the Council with regard to regulatory technical standards on settlement discipline (OJ L 230, 13.9.2018, pp. 1\u201353). See consolidated version. Commission Delegated Regulation (EU) 2017/389 of 11 November 2016 supplementing Regulation (EU) No 909/2014 of the European Parliament and of the Council as regards the parameters for the calculation of cash penalties for settlement fails and the operations of CSDs in host Member States (OJ L 65, 10.3.2017, pp. 1\u20138). Commission Delegated Regulation (EU) 2017/390 of 11 November 2016 supplementing Regulation (EU) No 909/2014 of the European Parliament and of the Council with regard to regulatory technical standards on certain prudential requirements for central securities depositories and designated credit institutions offering banking-type ancillary services (OJ L 65, 10.3.2017, pp. 9\u201343). See consolidated version. Commission Delegated Regulation (EU) 2017/391 of 11 November 2016 supplementing Regulation (EU) No 909/2014 of the European Parliament and of the Council with regard to regulatory technical standards further specifying the content of the reporting on internalised settlements (OJ L 65, 10.3.2017, pp. 44\u201347). Commission Delegated Regulation (EU) 2017/392 of 11 November 2016 supplementing Regulation (EU) No 909/2014 of the European Parliament and of the Council with regard to regulatory technical standards on authorisation, supervisory and operational requirements for central securities depositories (OJ L 65, 10.3.2017, pp. 48\u2013115). Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, pp. 349\u2013496). See consolidated version. last update 14.12.2021"}
{"article": "20.12.2013 EN Official Journal of the European Union L 347/281 REGULATION (EU) No 1300/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2013 on the Cohesion Fund and repealing Council Regulation (EC) No 1084/2006 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the second paragraph of Article 177 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure, Whereas: (1) The first paragraph of Article 174 of the Treaty on the Functioning of the European Union (TFEU) provides that the Union is to develop and pursue its actions leading to the strengthening of its economic, social and territorial cohesion. The Cohesion Fund which is established by this Regulation should, therefore, provide a financial contribution to projects in the fields of environment and trans-European networks in the area of transport infrastructure. (2) Regulation (EU) No 1303/2013 of the European Parliament and of the Council (3) sets out provisions common to the European Regional Development Fund (ERDF), the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund. That Regulation constitutes a new framework for the European Structural and Investment Funds including the Cohesion Fund. It is necessary, therefore, to specify the tasks of the Cohesion Fund in relation to that framework and in relation to the purpose assigned to the Cohesion Fund in the TFEU. (3) Specific provisions concerning the type of activities which can be supported by the Cohesion Fund, in order to contribute to the investment priorities within the thematic objectives set out in Regulation (EU) No 1303/2013, should be laid down. (4) The Union should be able to contribute, through the Cohesion Fund, to actions in pursuit of its environmental objectives, in accordance with Articles 11 and 191 TFEU, namely energy efficiency and renewable energy and, in the transport sector outside the trans-European networks, rail, river and sea transport, intermodal transport systems and their interoperability, management of road, sea and air traffic, clean urban transport and public transport. (5) It should be recalled that where measures based on Article 192(1) TFEU involve costs deemed disproportionate for the public authorities of a Member State and financial support from the Cohesion Fund is provided in accordance with Article 192(5) TFEU, the polluter pays principle is nevertheless to apply. (6) Trans-European transport network (TEN-T) projects supported by the Cohesion Fund are to comply with the guidelines established in Regulation (EU) No 1315/2013 of the European Parliament and of the Council (4). In order to concentrate efforts in that regard, priority should be given to projects of common interest as defined in that Regulation. (7) Investment to achieve the reduction of greenhouse gas emissions from activities listed in Annex I to Directive 2003/87/EC of the European Parliament and of the Council (5) should not be eligible for support from the Cohesion Fund as it already benefits financially from the application of that Directive. That exclusion should not restrict the possibility of using the Cohesion Fund to support activities that are not listed in Annex I to Directive 2003/87/EC even if those activities are implemented by the same economic operators, and include activities such as energy efficiency investment in the co-generation of heat and power and in district heating networks, smart energy distribution, storage and transmission systems and measures aimed at reducing air pollution, even if one of the indirect effects of such activities is the reduction of greenhouse gas emissions, or if they are listed in the national plan referred to in Directive 2003/87/EC. (8) It is not possible for investment in housing, other than that related to the promotion of energy efficiency or renewable energy use, to be eligible for support from the Cohesion Fund as it falls outside the scope of support from the Cohesion Fund as defined in the TFEU. (9) In order to accelerate the development of transport infrastructure across the Union, the Cohesion Fund should support transport infrastructure projects of European added value provided for in Regulation (EU) No 1316/2013 of the European Parliament and of the Council (6) for a total amount of EUR 10 000 000 000. The allocation of support from the Cohesion Fund to those projects should comply with the rules established under Article 92(6) of Regulation (EU) No 1303/2013. In accordance with Regulation (EU) No 1316/2013, support should be available only to Member States eligible for funding from the Cohesion Fund, with the co-financing rates applicable to that Fund. (10) It is important to ensure that, in promoting risk management investment, specific risks at regional, cross-border and transnational level are taken into account. (11) Complementarity and synergies between interventions supported by the Cohesion Fund, the ERDF, the European territorial cooperation goal and the Connecting Europe Facility should be ensured, in order to avoid duplication of efforts and to guarantee the optimal linkage of different types of infrastructure at local, regional and national level, and throughout the Union. (12) In order to address the specific needs of the Cohesion Fund, and in line with the Union strategy for smart, sustainable and inclusive growth, it is necessary to set out within each thematic objective laid down in Regulation (EU) No 1303/2013, the Cohesion Fund-specific actions as 'investment priorities'. Those investment priorities should set out detailed objectives, which are not mutually exclusive, to which the Cohesion Fund is to contribute. Such investment priorities should form the basis for the definition of specific objectives within operational programmes that take into account the needs and characteristics of the programme area. In order to increase flexibility and reduce the administrative burden through joint implementation, the ERDF and the Cohesion Fund investment priorities under the corresponding thematic objectives should be aligned. (13) A common set of output indicators to assess the aggregated progress at Union level of the implementation of operational programmes should be set out in an Annex to this Regulation. Those indicators should correspond to the investment priority and type of action supported in accordance with this Regulation and the relevant provisions of Regulation (EU) No 1303/2013. The common output indicators should be complemented by programme-specific result indicators and, where relevant, by programme-specific output indicators. (14) In order to amend this Regulation with regard to certain non-essential elements, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the amendment of the list of common output indicators set out in Annex I to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. (15) Since the objective of this Regulation, namely to strengthen the economic, social and territorial cohesion of the Union in the interests of promoting sustainable development, cannot be sufficiently achieved by the Member States but can rather, by reason of the extent of the disparities between the levels of development of the various regions and the backwardness of the least favoured regions and the limit on the financial resources of the Member States and regions, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (16) Since this Regulation replaces Council Regulation (EC) No 1084/2006 (7), that Regulation should be repealed. However, this Regulation should not affect either the continuation or modification of assistance approved by the Commission on the basis of Regulation (EC) No 1084/2006 or any other legislation applying to that assistance on 31 December 2013. That Regulation or such other applicable legislation should consequently continue to apply after 31 December 2013 to that assistance or the operations concerned until their closure. Applications to receive assistance made or approved under Regulation (EC) No 1084/2006 should remain valid. (17) In order to allow for the prompt application of the measures provided for in this Regulation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: Article 1 Establishment of the Cohesion Fund and subject matter 1. A Cohesion Fund is hereby established for the purpose of strengthening the economic, social and territorial cohesion of the Union in the interests of promoting sustainable development. 2. This Regulation establishes the tasks of the Cohesion Fund and the scope of its support with regard to the Investment for growth and jobs goal referred to in Article 89 of Regulation (EU) No 1303/2013. Article 2 Scope of support from the Cohesion Fund 1. The Cohesion Fund shall, while ensuring an appropriate balance and according to the investment and infrastructure needs specific to each Member State, support: (a) investment in the environment, including areas related to sustainable development and energy which present environmental benefits; (b) TEN-T, in compliance with the guidelines adopted by Regulation (EU) No 1315/2013; (c) technical assistance. 2. The Cohesion Fund shall not support: (a) the decommissioning or the construction of nuclear power stations; (b) investment to achieve the reduction of greenhouse gas emissions from activities listed in Annex I to Directive 2003/87/EC; (c) investment in housing unless related to the promotion of energy efficiency or renewable energy use; (d) the manufacturing, processing and marketing of tobacco and tobacco products; (e) undertakings in difficulty, as defined under Union State aid rules; (f) investment in airport infrastructure unless related to environmental protection or accompanied by investment necessary to mitigate or reduce its negative environmental impact. Article 3 Cohesion Fund support for transport infrastructure projects under the Connecting Europe Facility The Cohesion Fund shall support transport infrastructure projects of European added value provided for in Regulation (EU) No 1316/2013 for an amount of EUR 10 000 000 000 in accordance with Article 92(6) of Regulation (EU) No 1303/2013. Article 4 Investment priorities The Cohesion Fund shall support the following investment priorities within the thematic objectives set out in the first paragraph of Article 9 of Regulation (EU) No 1303/2013, in accordance with the development needs and growth potential referred to in point (a)(i) of Article 15(1) of that Regulation and set out in the Partnership Agreement: (a) supporting the shift towards a low-carbon economy in all sectors by: (i) promoting the production and distribution of energy derived from renewable sources; (ii) promoting energy efficiency and renewable energy use in enterprises; (iii) supporting energy efficiency, smart energy management and renewable energy use in public infrastructure, including in public buildings, and in the housing sector; (iv) developing and implementing smart distribution systems that operate at low and medium voltage levels; (v) promoting low-carbon strategies for all types of territories, in particular for urban areas, including the promotion of sustainable multimodal urban mobility and mitigation-relevant adaptation measures; (vi) promoting the use of high-efficiency co-generation of heat and power based on useful heat demand; (b) promoting climate change adaptation, risk prevention and management by: (i) supporting investment for adaptation to climate change, including ecosystem-based approaches; (ii) promoting investment to address specific risks, ensuring disaster resilience and developing disaster management systems; (c) preserving and protecting the environment and promoting resource efficiency by: (i) investing in the waste sector to meet the requirements of the Union's environmental acquis and to address needs, identified by the Member States, for investment that goes beyond those requirements; (ii) investing in the water sector to meet the requirements of the Union's environmental acquis and to address needs, identified by the Member States, for investment that goes beyond those requirements; (iii) protecting and restoring biodiversity and soil and promoting ecosystem services, including through Natura 2000, and green infrastructure; (iv) taking action to improve the urban environment, to revitalise cities, regenerate and decontaminate brownfield sites (including conversion areas), reduce air pollution and promote noise-reduction measures; (d) promoting sustainable transport and removing bottlenecks in key network infrastructures by: (i) supporting a multimodal Single European Transport Area by investing in the TEN-T; (ii) developing and improving environmentally-friendly (including low-noise) and low-carbon transport systems, including inland waterways and maritime transport, ports, multimodal links and airport infrastructure, in order to promote sustainable regional and local mobility; (iii) developing and rehabilitating comprehensive, high quality and interoperable railway systems, and promoting noise-reduction measures; (e) enhancing institutional capacity of public authorities and stakeholders and efficient public administration through actions to strengthen the institutional capacity and the efficiency of public administrations and public services related to the implementation of the Cohesion Fund. Article 5 Indicators 1. Common output indicators, as set out in Annex I to this Regulation, programme-specific result indicators and, where relevant, programme-specific output indicators shall be used in accordance with Article 27(4) and point (b)(ii) and (iv) and point (c)(ii) and (iv) of Article 96(2) of Regulation (EU) No 1303/2013. 2. For common and programme-specific output indicators, baselines shall be set at zero. Cumulative quantified target values for those indicators shall be set for 2023. 3. For programme-specific result indicators, which relate to investment priorities, baselines shall use the latest available data and targets shall be set for 2023. Targets may be expressed in quantitative or qualitative terms. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 7 to amend the list of common output indicators set out in Annex I, in order to make adjustments, where justified to ensure effective assessment of progress in operational programme implementation. Article 6 Transitional provisions 1. This Regulation shall not affect either the continuation or modification, including the total or partial cancellation of assistance approved by the Commission on the basis of Regulation (EC) No 1084/2006 or any other legislation applying to that assistance on 31 December 2013. That Regulation or such other applicable legislation shall consequently continue to apply after 31 December 2013 to that assistance or the operations concerned until their closure. For the purposes of this paragraph assistance shall cover operational programmes and major projects. 2. Applications to receive assistance made or approved under Regulation (EC) No 1084/2006 shall remain valid. Article 7 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 5(4) shall be conferred on the Commission from 21 December 2013 until 31 December 2020. 3. The delegation of power referred to in Article 5(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 5(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. Article 8 Repeal Without prejudice to Article 6 of this Regulation, Regulation (EC) No 1084/2006 is hereby repealed with effect from 1 January 2014. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex II. Article 9 Review The European Parliament and the Council shall review this Regulation by 31 December 2020, in accordance with Article 177 TFEU. Article 10 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 December 2013. For the European Parliament The President M. SCHULZ For the Council The President R. \u0160AD\u017dIUS (1) OJ C 191, 29.6.2012, p. 38. (2) OJ C 225, 27.7.2012, p. 143. (3) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (See page 320 of this Official Journal). (4) Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, p. 1). (5) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32). (6) Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010 (OJ L 348, 20.12.2013, p. 129). (7) Council Regulation (EC) No 1084/2006 of 11 July 2006 establishing a Cohesion Fund and repealing Regulation (EC) No 1164/94 (OJ L 210, 31.7.2006, p. 79). ANNEX I COMMON OUTPUT INDICATORS FOR THE COHESION FUND UNIT NAME Environment Solid waste tonnes/year Additional waste recycling capacity Water supply persons Additional population served by improved water supply Wastewater treatment population equivalent Additional population served by improved wastewater treatment Risk prevention and management persons Population benefiting from flood protection measures persons Population benefiting from forest fire protection measures Land rehabilitation hectares Total surface area of rehabilitated land Nature and biodiversity hectares Surface area of habitats supported in order to attain a better conservation status Energy and climate change Renewables MW Additional capacity of renewable energy production Energy efficiency households Number of households with improved energy consumption classification kWh/year Decrease of annual primary energy consumption of public buildings users Number of additional energy users connected to smart grids GHG reduction tonnes of CO2eq Estimated annual decrease of GHG Transport Railway kilometres Total length of new railway lines kilometres Total length of reconstructed or upgraded railway lines Roads kilometres Total length of newly built roads kilometres Total length of reconstructed or upgraded roads Urban transport kilometres Total length of new or improved tram and metro lines Inland waterways kilometres Total length of new or improved inland waterways ANNEX II CORRELATION TABLE Regulation (EC) No 1084/2006 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 \u2014 Article 4 \u2014 \u2014 Article 3 \u2014 Article 4 \u2014 Article 5 Article 5 Article 6 Article 5a \u2014 \u2014 Article 7 Article 6 Article 8 Article 7 Article 9 Article 8 Article 10 Joint statement of the European Parliament and of the Council concerning the application of Article 6 of the ERDF Regulation, Article 15 of the ETC Regulation and Article 4 of the Cohesion Fund Regulation The European Parliament and the Council note the assurance provided by the Commission to the EU legislature that the common output indicators for the ERDF Regulation, the ETC Regulation and the Cohesion Fund Regulation to be included in an annex to, respectively, each regulation, are the outcome of a lengthy preparatory process involving the evaluation experts of both the Commission and the Member States and, in principle, are expected to remain stable.", "summary": "Cohesion Fund (2014-20) Cohesion Fund (2014-20) This regulation sets out the objectives for the EU\u2019s Cohesion Fund for the funding period 2014-20. The Fund is one of the EU's financial instruments that aim to narrow the disparities in development between the regions. ACT Regulation (EU) No 1300/2013 of the European Parliament and of the Council of 17 December 2013 on the Cohesion Fund and repealing Council Regulation (EC) No 1084/2006. SUMMARY The Cohesion Fund provides support for the poorer regions of the EU with a view to promoting growth, employment and sustainable development. Member States with a gross national income (GNI) per inhabitant below 90 % of the EU average are eligible for funding from the Cohesion Fund. The ceiling for the Cohesion Fund's contribution to public expenditure in the Member States is set at 85 %. Fields of activity The Cohesion Fund co-finances action to: \u2014 develop trans-European transport networks; \u2014 further the EU\u2019s environmental objectives, i.e. the promotion of energy efficiency and renewable energy and support for sustainable transport projects which do not form part of trans-European transport networks; \u2014 provide technical assistance. Investment priorities include projects that promote: \u2014 a low-carbon economy; \u2014 climate change adaptation, risk prevention and management; \u2014 environmental protection/conservation. \u2014 sustainable transport and removing bottlenecks. A total of EUR 10 billion will be available in the funding period 2014-20 to co-finance transport infrastructure projects of European added value provided for in the Connecting Europe Facility Regulation (No 1316/2013) Eligible expenditure Eligibility is decided at national level. However, the following types of expenditure are not eligible for Cohesion Fund financing: \u2014 the decommissioning or the construction of nuclear power stations; \u2014 investment to achieve the reduction of greenhouse gas emissions from activities covered by the Emissions Trade Scheme (ETS); \u2014 housing (except for energy efficiency or renewable energy use); \u2014 the manufacturing, processing and marketing of tobacco; \u2014 help to companies in difficulty; \u2014 investment in airport infrastructure (unless related to environmental protection or accompanied by measures to mitigate negative environmental impact). The regulation must be reviewed by 31 December 2020. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 1300/2013 21.12.2013 - OJ L 347 of 20.12.2013 RELATED ACTS Commission Implementing Decision 2014/99/EU setting out the list of regions eligible for funding from the European Regional Development Fund and the European Social Fund and of Member States eligible for funding from the Cohesion Fund for the period 2014-2020 (OJ L 50 of 20.2.2014). Regulation (EU) No 1303/2013 of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (OJ L 347 of 20.12.2013). Last updated: 17.04.2014"}
{"article": "20.12.2013 EN Official Journal of the European Union L 347/289 REGULATION (EU) No 1301/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2013 on the European Regional Development Fund and on specific provisions concerning the Investment for growth and jobs goal and repealing Regulation (EC) No 1080/2006 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 178 and 349 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure, Whereas: (1) Article 176 of the Treaty on the Functioning of the European Union (TFEU) provides that the European Regional Development Fund (ERDF) is intended to help to redress the main regional imbalances in the Union. Under that Article and the second and third paragraphs of Article 174 TFEU, the ERDF is to contribute to reducing disparities between the levels of development of the various regions and to reducing the backwardness of the least favoured regions, among which particular attention is to be paid to regions which suffer from severe and permanent natural or demographic handicaps such as the northernmost regions with very low population density and island, cross-border and mountain regions. (2) Regulation (EU) No 1303/2013 of the European Parliament and of the Council (3) sets out the provisions common to the ERDF, the European Social Fund (ESF), the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund. (3) Specific provisions concerning the type of activities which can be supported by the ERDF, in order to contribute to the investment priorities within the thematic objectives set out in Regulation (EU) No 1303/2013, should be laid down. At the same time, activities outside the scope of the ERDF should be defined and clarified, including investment to achieve the reduction of greenhouse gas emissions from activities listed in Annex I to Directive 2003/87/EC of the European Parliament and of the Council (4). In order to avoid excessive financing, such investment should not be eligible for support from the ERDF as it already benefits financially from the application of Directive 2003/87/EC. That exclusion should not restrict the possibility of using the ERDF to support activities that are not listed in Annex I to Directive 2003/87/EC even if those activities are implemented by the same economic operators, and include activities such as energy efficiency investments in district heating networks, smart energy distribution, storage and transmission systems and measures aimed at reducing air pollution, even if one of the indirect effects of such activities is the reduction of greenhouse gas emissions, or if they are listed in the national plan referred to in Directive 2003/87/EC. (4) It is necessary to specify what additional activities can be supported by the ERDF under the European territorial cooperation goal. (5) The ERDF should contribute to the Union strategy for smart, sustainable and inclusive growth, thus ensuring greater concentration of ERDF support on the priorities of the Union. Depending on which category of regions is supported, the support from the ERDF under the Investment for growth and jobs goal should be concentrated on research and innovation, information and communication technologies (ICT), small and medium-sized enterprises (SMEs) and promoting a low-carbon economy. That thematic concentration should be attained at national level while allowing for flexibility at the level of operational programmes and between different categories of regions. The thematic concentration should be adjusted, where appropriate, to take into account Cohesion Fund resources allocated to supporting the investment priorities relating to the shift towards a low-carbon economy and referred to in Regulation (EU) No 1300/2013 of the European Parliament and of the Council (5). The degree of thematic concentration should take into account the level of development of the region, the contribution of Cohesion Fund resources where applicable, as well as the specific needs of regions whose GDP per capita used as an eligibility criterion for the 2007-2013 programming period was less than 75 % of the average GDP of the EU-25 for the reference period, regions designated with phasing-out status in the 2007-2013 programming period and certain NUTS level 2 regions consisting solely of island Member States or of islands. (6) It should be possible for support from the ERDF under the investment priority 'community-led local development' to contribute to all of the thematic objectives referred to in this Regulation. (7) In order to address the specific needs of the ERDF, and in line with the Union strategy for smart, sustainable and inclusive growth, it is necessary to set out within each thematic objective laid down in Regulation (EU) No 1303/2013, the ERDF-specific actions as 'investment priorities'. Those investment priorities should set out detailed objectives, which are not mutually exclusive, to which the ERDF is to contribute. Such investment priorities should form the basis for the definition of specific objectives within programmes that take into account the needs and characteristics of the programme area. (8) It is necessary to promote innovation and the development of SMEs, in emerging fields linked to European and regional challenges such as creative and cultural industries and innovative services, reflecting new societal demands, or to products and services linked to an ageing population, care and health, eco-innovation, the low-carbon economy and resource efficiency. (9) In accordance with Regulation (EU) No 1303/2013, in order to optimise the added value from investments funded wholly or in part through the Union budget in the field of research and innovation, synergies will be sought in particular between the operation of the ERDF and Horizon 2020 - the Framework Programme for Research and Innovation whilst respecting their distinct objectives. (10) It is important to ensure that, in promoting risk management investments, specific risks at regional, cross-border and transnational level are taken into account. (11) In order to maximise their contribution to the objective of supporting employment-friendly growth, activities supporting sustainable tourism, culture and natural heritage should be part of a territorial strategy for specific areas, including the conversion of declining industrial regions. Support for such activities should also contribute to strengthening innovation and the use of ICT, SMEs, environment and resource efficiency or the promotion of social inclusion. (12) In order to promote sustainable regional or local mobility or to reduce air and noise pollution, it is necessary to promote healthy, sustainable and safe modes of transport. Investments in airport infrastructure supported by the ERDF should promote environmentally sustainable air transport when, inter alia, enhancing regional mobility by connecting secondary and tertiary nodes to trans-European transport network (TEN-T) infrastructure, including through multimodal nodes. (13) In order to promote the achievement of the energy and climate targets set by the Union as part of the Union strategy for smart, sustainable and inclusive growth, the ERDF should support investment to promote energy efficiency and security of supply in Member States through, inter alia, the development of smart energy distribution, storage and transmission systems, including through the integration of distributed generation from renewable sources. In order to meet their security of supply requirements in a manner that is consistent with their targets under the Union strategy for smart, sustainable and inclusive growth, Member States should be able to invest in energy infrastructure that is consistent with their chosen energy mix. (14) SMEs, which can include social economy enterprises, should be understood, in accordance with the definition laid down in Regulation (EU) No 1303/2013, as covering micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC (6). (15) In order to promote social inclusion and combat poverty, particularly among marginalised communities, it is necessary to improve access to social, cultural and recreational services, through the provision of small-scale infrastructure, taking account of the specific needs of persons with disabilities and the elderly. (16) Community-based services should cover all forms of in-home, family-based, residential and other community services which support the right of all persons to live in the community, with an equality of choices, and which seek to prevent isolation or segregation from the community. (17) In order to increase flexibility and reduce the administrative burden through joint implementation, the ERDF and the Cohesion Fund investment priorities under the corresponding thematic objectives should be aligned. (18) A common set of output indicators to assess the aggregated progress at Union level of the implementation of programmes should be set out in an Annex to this Regulation. Those indicators should correspond to the investment priority and type of action supported in accordance with this Regulation and the relevant provisions of Regulation (EU) No 1303/2013. The common output indicators should be complemented by programme-specific result indicators and, where relevant, by programme-specific output indicators. (19) Within the framework of sustainable urban development, it is considered necessary to support integrated actions to tackle the economic, environmental, climate, demographic and social challenges affecting urban areas, including functional urban areas, while taking into account the need to promote urban-rural linkages. The principles for selecting the urban areas where integrated actions for sustainable urban development are to be implemented, and the indicative amounts for those actions, should be set out in the Partnership Agreement with a minimum of 5 % of the ERDF resources allocated at national level for that purpose. The scope of any delegation of tasks to urban authorities should be decided upon by the managing authority in consultation with the urban authority. (20) In order to identify or test new solutions which address issues that are related to sustainable urban development and are of relevance at Union level, the ERDF should support innovative actions in the area of sustainable urban development. (21) In order to reinforce capacity-building, networking and exchange of experience between programmes and bodies responsible for implementing sustainable urban development strategies and innovative actions in the area of sustainable urban development and to complement existing programmes and bodies, it is necessary to establish an urban development network at Union level. (22) The ERDF should address the problems of accessibility to, and remoteness from, large markets, faced by areas with an extremely low population density, as referred to in Protocol No 6 on special provisions for Objective 6 in the framework of the Structural Funds in Finland and Sweden to the 1994 Act of Accession. The ERDF should also address the specific difficulties encountered by certain islands, border regions, mountain regions and sparsely populated areas, the geographical situation of which slows down their development, with a view to supporting their sustainable development. (23) Specific attention should be paid to the outermost regions, namely by adopting measures under Article 349 TFEU extending, on an exceptional basis, the scope of support from the ERDF to the financing of operating aid linked to the offsetting of the additional costs resulting from the specific economic and social situation of those regions which is compounded by the handicaps resulting from the factors referred to in Article 349 TFEU, namely remoteness, insularity, small size, difficult topography and climate, economic dependence on a few products, the permanence and combination of which severely restrain their development. Operating aid granted by Member States in that context is exempt from the notification obligation laid down in Article 108(3) TFEU, if, at the time it is granted, it fulfils the conditions laid down by a Regulation declaring certain categories of aid compatible with the internal market in application of Articles 107 and 108 TFEU, and adopted pursuant to Council Regulation (EC) No 994/98 (7). (24) In line with the conclusions of the European Council of 7-8 February 2013, and taking into account the special objectives laid down in the TFEU concerning the outermost regions referred to in Article 349 TFEU, the status of Mayotte was changed as a result of European Council Decision 2012/419/EU (8) to become a new outermost region from 1 January 2014. In order to facilitate and to promote focused and rapid infrastructural development of Mayotte, it should be possible on an exceptional basis that at least 50 % of the ERDF part of Mayotte's envelope be allocated to five of the thematic objectives laid down in Regulation (EU) No 1303/2013. (25) In order to supplement this Regulation with certain non-essential elements, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of detailed rules for the criteria for the selection and management of innovative actions. Such power should also be delegated to the Commission in respect of amendments to Annex I to this Regulation where justified to ensure the effective assessment of progress in implementation of operational programmes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (26) Since the objective of this Regulation, namely to reinforce economic, social and territorial cohesion by redressing the main regional imbalances in the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of the extent of the disparities between the levels of development of the various regions and the backwardness of the least favoured regions and the limit on the financial resources of the Member States and regions, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (27) This Regulation replaces Regulation (EC) No 1080/2006 of the European Parliament and the Council (9). In the interests of clarity, Regulation (EC) No 1080/2006 should therefore be repealed. However, this Regulation should not affect either the continuation or modification of assistance approved by the Commission on the basis of Regulation (EC) No 1080/2006 or any other legislation applying to that assistance on 31 December 2013. That Regulation or such other applicable legislation should consequently continue to apply after 31 December 2013 to that assistance or the operations concerned until their closure. Applications to receive assistance made or approved under Regulation (EC) No 1080/2006 should remain valid. (28) In order to allow for the prompt application of the measures provided for in this Regulation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: CHAPTER I Common provisions Article 1 Subject matter This Regulation establishes the tasks of the European Regional Development Fund (ERDF), the scope of its support with regard to the Investment for growth and jobs goal and the European territorial cooperation goal and specific provisions concerning ERDF support for the Investment for growth and jobs goal. Article 2 Tasks of the ERDF The ERDF shall contribute to the financing of support which aims to reinforce economic, social and territorial cohesion by redressing the main regional imbalances in the Union through the sustainable development and structural adjustment of regional economies, including the conversion of declining industrial regions and regions whose development is lagging behind. Article 3 Scope of support from the ERDF 1. The ERDF shall support the following activities in order to contribute to the investment priorities set out in Article 5: (a) productive investment which contributes to creating and safeguarding sustainable jobs, through direct aid for investment in SMEs; (b) productive investment, irrespective of the size of the enterprise concerned, which contributes to the investment priorities set out in points (1) and (4) of Article 5, and, where that investment involves cooperation between large enterprises and SMEs, in point (2) of Article 5; (c) investment in infrastructure providing basic services to citizens in the areas of energy, environment, transport and ICT; (d) investment in social, health, research, innovation, business and educational infrastructure; (e) investment in the development of endogenous potential through fixed investment in equipment and small-scale infrastructure, including small-scale cultural and sustainable tourism infrastructure, services to enterprises, support to research and innovation bodies and investment in technology and applied research in enterprises; (f) networking, cooperation and exchange of experience between competent regional, local, urban and other public authorities, economic and social partners and relevant bodies representing civil society, referred to in Article 5(1) of Regulation (EU) No 1303/2013, studies, preparatory actions and capacity-building. 2. Under the European territorial cooperation goal, the ERDF may also support the sharing of facilities and human resources, and all types of infrastructure across borders in all regions. 3. The ERDF shall not support: (a) the decommissioning or the construction of nuclear power stations; (b) investment to achieve the reduction of greenhouse gas emissions from activities listed in Annex I to Directive 2003/87/EC; (c) the manufacturing, processing and marketing of tobacco and tobacco products; (d) undertakings in difficulty, as defined under Union State aid rules; (e) investment in airport infrastructure unless related to environmental protection or accompanied by investment necessary to mitigate or reduce its negative environmental impact. Article 4 Thematic concentration 1. The thematic objectives set out in the first paragraph of Article 9 of Regulation (EU) No 1303/2013 and the corresponding investment priorities set out in Article 5 of this Regulation to which the ERDF may contribute under the Investment for growth and jobs goal, shall be concentrated as follows: (a) in more developed regions: (i) at least 80 % of the total ERDF resources at national level shall be allocated to two or more of the thematic objectives set out in points 1, 2, 3 and 4 of the first paragraph of Article 9 of Regulation (EU) No 1303/2013; and (ii) at least 20 % of the total ERDF resources at national level shall be allocated to the thematic objective set out in point 4 of the first paragraph of Article 9 of Regulation (EU) No 1303/2013; (b) in transition regions: (i) at least 60 % of the total ERDF resources at national level shall be allocated to two or more of the thematic objectives set out in points 1, 2, 3 and 4 of the first paragraph of Article 9 of Regulation (EU) No 1303/2013; and (ii) at least 15 % of the total ERDF resources at national level shall be allocated to the thematic objective set out in point 4 of the first paragraph of Article 9 of Regulation (EU) No 1303/2013; (c) in less developed regions: (i) at least 50 % of the total ERDF resources at national level shall be allocated to two or more of the thematic objectives set in out in points 1, 2, 3 and 4 of the first paragraph of Article 9 of Regulation (EU) No 1303/2013; and (ii) at least 12 % of the total ERDF resources at national level shall be allocated to the thematic objective set out in point 4 of the first paragraph of Article 9 of Regulation (EU) No 1303/2013. For the purpose of this Article, regions whose GDP per capita used as an eligibility criterion for the 2007-2013 programming period was less than 75 % of the average GDP of the EU-25 for the reference period, and regions designated with phasing-out status in the 2007-2013 programming period, but which are eligible under the category of more developed regions as referred to in point (c) of the first subparagraph of Article 90(2) of Regulation (EU) No 1303/2013 in the 2014-2020 programming period, shall be considered as transition regions. For the purpose of this Article, all NUTS level 2 regions consisting solely of island Member States or of islands which form part of Member States which receive support from the Cohesion Fund, and all outermost regions, shall be considered as less developed regions. 2. By way of derogation from paragraph 1 of this Article, the minimum ERDF share allocated to a category of region may be lower than that set out in that paragraph, provided that such a decrease is compensated by an increase in the share allocated to other categories of regions. The resulting sum at national level of the amounts for all categories of region respectively for the thematic objectives set out in points 1, 2, 3 and 4 of the first paragraph of Article 9 of Regulation (EU) No 1300/2013 and those set out in point 4 of the first paragraph of Article 9 of Regulation (EU) No 1303/2013 shall accordingly not be less than the sum at national level resulting from applying the minimum ERDF shares set out in paragraph 1 of this Article. 3. By way of derogation from paragraph 1 of this Article, Cohesion Fund resources allocated to supporting the investment priorities set out in point (a) of Article 4 of Regulation (EU) No 1300/2013 may be counted towards achieving the minimum shares set out in points (a)(ii), (b)(ii) and (c)(ii) of the first subparagraph of paragraph 1 of this Article. In such a case, the share referred to in point (c)(ii) of the first subparagraph of paragraph 1 of this Article shall be increased to 15 %. Where applicable, those resources shall be allocated pro rata to the different categories of region based on their relative shares of the total population of the Member State concerned. Article 5 Investment priorities The ERDF shall support the following investment priorities within the thematic objectives set out in the first paragraph of Article 9 of Regulation (EU) No 1303/2013, in accordance with the development needs and growth potential referred to in point (a)(i) of Article 15(1) of that Regulation and set out in the Partnership Agreement: (1) strengthening research, technological development and innovation by: (a) enhancing research and innovation (R&I) infrastructure and capacities to develop R&I excellence, and promoting centres of competence, in particular those of European interest; (b) promoting business investment in R&I, developing links and synergies between enterprises, research and development centres and the higher education sector, in particular promoting investment in product and service development, technology transfer, social innovation, eco-innovation, public service applications, demand stimulation, networking, clusters and open innovation through smart specialisation, and supporting technological and applied research, pilot lines, early product validation actions, advanced manufacturing capabilities and first production, in particular in key enabling technologies and diffusion of general purpose technologies; (2) enhancing access to, and use and quality of, ICT by: (a) extending broadband deployment and the roll-out of high-speed networks and supporting the adoption of emerging technologies and networks for the digital economy; (b) developing ICT products and services, e-commerce, and enhancing demand for ICT; (c) strengthening ICT applications for e-government, e-learning, e-inclusion, e-culture and e-health; (3) enhancing the competitiveness of SMEs by: (a) promoting entrepreneurship, in particular by facilitating the economic exploitation of new ideas and fostering the creation of new firms, including through business incubators; (b) developing and implementing new business models for SMEs, in particular with regard to internationalisation; (c) supporting the creation and the extension of advanced capacities for product and service development; (d) supporting the capacity of SMEs to grow in regional, national and international markets, and to engage in innovation processes; (4) supporting the shift towards a low-carbon economy in all sectors by: (a) promoting the production and distribution of energy derived from renewable sources; (b) promoting energy efficiency and renewable energy use in enterprises; (c) supporting energy efficiency, smart energy management and renewable energy use in public infrastructure, including in public buildings, and in the housing sector; (d) developing and implementing smart distribution systems that operate at low and medium voltage levels; (e) promoting low-carbon strategies for all types of territories, in particular for urban areas, including the promotion of sustainable multimodal urban mobility and mitigation-relevant adaptation measures; (f) promoting research and innovation in, and adoption of, low-carbon technologies; (g) promoting the use of high-efficiency co-generation of heat and power based on useful heat demand; (5) promoting climate change adaptation, risk prevention and management by: (a) supporting investment for adaptation to climate change, including ecosystem-based approaches; (b) promoting investment to address specific risks, ensuring disaster resilience and developing disaster management systems; (6) preserving and protecting the environment and promoting resource efficiency by: (a) investing in the waste sector to meet the requirements of the Union's environmental acquis and to address needs, identified by the Member States, for investment that goes beyond those requirements; (b) investing in the water sector to meet the requirements of the Union's environmental acquis and to address needs, identified by the Member States, for investment that goes beyond those requirements; (c) conserving, protecting, promoting and developing natural and cultural heritage; (d) protecting and restoring biodiversity and soil and promoting ecosystem services, including through Natura 2000, and green infrastructure; (e) taking action to improve the urban environment, to revitalise cities, regenerate and decontaminate brownfield sites (including conversion areas), reduce air pollution and promote noise-reduction measures; (f) promoting innovative technologies to improve environmental protection and resource efficiency in the waste sector, water sector and with regard to soil, or to reduce air pollution; (g) supporting industrial transition towards a resource-efficient economy, promoting green growth, eco-innovation and environmental performance management in the public and private sectors; (7) promoting sustainable transport and removing bottlenecks in key network infrastructures by: (a) supporting a multimodal Single European Transport Area by investing in the TEN-T; (b) enhancing regional mobility by connecting secondary and tertiary nodes to TEN-T infrastructure, including multimodal nodes; (c) developing and improving environmentally-friendly (including low-noise) and low-carbon transport systems, including inland waterways and maritime transport, ports, multimodal links and airport infrastructure, in order to promote sustainable regional and local mobility; (d) developing and rehabilitating comprehensive, high quality and interoperable railway systems, and promoting noise-reduction measures; (e) improving energy efficiency and security of supply through the development of smart energy distribution, storage and transmission systems and through the integration of distributed generation from renewable sources; (8) promoting sustainable and quality employment and supporting labour mobility by: (a) supporting the development of business incubators and investment support for self-employment, micro-enterprises and business creation; (b) supporting employment-friendly growth through the development of endogenous potential as part of a territorial strategy for specific areas, including the conversion of declining industrial regions and enhancement of accessibility to, and development of, specific natural and cultural resources; (c) supporting local development initiatives and aid for structures providing neighbourhood services to create jobs, where such actions are outside the scope of Regulation (EU) No 1304/2013 of the European Parliament and of the Council (10); (d) investing in infrastructure for employment services; (9) promoting social inclusion, combating poverty and any discrimination, by: (a) investing in health and social infrastructure which contributes to national, regional and local development, reducing inequalities in terms of health status, promoting social inclusion through improved access to social, cultural and recreational services and the transition from institutional to community-based services; (b) providing support for physical, economic and social regeneration of deprived communities in urban and rural areas; (c) providing support for social enterprises; (d) undertaking investment in the context of community-led local development strategies; (10) investing in education, training and vocational training for skills and lifelong learning by developing education and training infrastructure; (11) enhancing institutional capacity of public authorities and stakeholders and efficient public administration through actions to strengthen the institutional capacity and the efficiency of public administrations and public services related to the implementation of the ERDF, and in support of actions under the ESF to strengthen the institutional capacity and the efficiency of public administration. Article 6 Indicators for the Investment for growth and jobs goal 1. Common output indicators, as set out in Annex I to this Regulation, programme-specific result indicators and, where relevant, programme-specific output indicators shall be used in accordance with Article 27(4) and point (b)(ii) and (iv) and point (c)(ii) and (iv) of Article 96(2) of Regulation (EU) No 1303/2013. 2. For common and programme-specific output indicators, baselines shall be set at zero. Cumulative quantified target values for those indicators shall be set for 2023. 3. For programme-specific result indicators, which relate to investment priorities, baselines shall use the latest available data and targets shall be set for 2023. Targets may be expressed in quantitative or qualitative terms. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 14 to amend the list of common output indicators set out in Annex I, in order to make adjustments, where justified to ensure effective assessment of progress in the implementation of operational programmes. CHAPTER II Specific provisions on the treatment of particular territorial features Article 7 Sustainable urban development 1. The ERDF shall support, within operational programmes, sustainable urban development through strategies that set out integrated actions to tackle the economic, environmental, climate, demographic and social challenges affecting urban areas, while taking into account the need to promote urban-rural linkages. 2. Sustainable urban development shall be undertaken through Integrated territorial investment as referred to in Article 36 of Regulation (EU) No 1303/2013, or through a specific operational programme, or through a specific priority axis in accordance with point (c) of the first subparagraph of Article 96(1) of Regulation (EU) No 1303 /2013. 3. Taking into account its specific territorial situation, each Member State shall establish in its Partnership Agreement the principles for the selection of urban areas where integrated actions for sustainable urban development are to be implemented and an indicative allocation for those actions at national level. 4. At least 5 % of the ERDF resources allocated at national level under the Investment for growth and jobs goal shall be allocated to integrated actions for sustainable urban development where cities, sub-regional or local bodies responsible for implementing sustainable urban strategies (\"urban authorities\") shall be responsible for tasks relating, at least, to the selection of operations in accordance with Article 123(6) of Regulation (EU) No 1303/2013, or, where appropriate, in accordance with Article 123(7) of that Regulation. The indicative amount to be dedicated for the purposes of paragraph 2 of this Article shall be set out in the operational programme or programmes concerned. 5. The managing authority shall determine, in consultation with the urban authority, the scope of tasks, to be undertaken by urban authorities, concerning the management of integrated actions for sustainable urban development. The managing authority shall formally record its decision in writing. The managing authority may retain the right to undertake a final verification of eligibility of operations before approval. Article 8 Innovative actions in the area of sustainable urban development 1. At the initiative of the Commission, the ERDF may support innovative actions in the area of sustainable urban development in accordance with Article 92(8) of Regulation (EU) No 1303/2013. Such actions shall include studies and pilot projects to identify or test new solutions which address issues that are related to sustainable urban development and are of relevance at Union level. The Commission shall encourage the involvement of relevant partners referred to in Article 5(1) of Regulation (EU) No 1303/2013 in the preparation and implementation of innovative actions. 2. By way of derogation from Article 4 of this Regulation, innovative actions may support all activities necessary to achieve the thematic objectives set out in the first paragraph of Article 9 of Regulation (EU) No 1303/2013 and the corresponding investment priorities set out in Article 5 of this Regulation. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 14 laying down detailed rules concerning the principles for the selection and management of innovative actions to be supported by the ERDF in accordance with this Regulation. Article 9 Urban development network 1. The Commission shall establish, in accordance with Article 58 of Regulation (EU) No 1303/2013 an urban development network to promote capacity-building, networking and exchange of experience at Union level between urban authorities responsible for implementing sustainable urban development strategies in accordance with Article 7(4) and (5) of this Regulation and authorities responsible for innovative actions in the area of sustainable urban development in accordance with Article 8 of this Regulation. 2. The activities of the urban development network shall be complementary to those undertaken under interregional cooperation pursuant to point (3)(b) of Article 2 of Regulation (EU) No 1299/2013 of the European Parliament and of the Council (11). Article 10 Areas with natural or demographic handicaps In operational programmes co-financed by the ERDF, covering areas with severe and permanent natural or demographic handicaps as referred to in point 4 of Article 121 of Regulation (EU) No 1303/2013, particular attention shall be paid to addressing the specific difficulties of those areas. Article 11 Northernmost regions with very low population density Article 4 shall not apply to the specific additional allocation for the northernmost regions with very low population density. That allocation shall be allocated to the thematic objectives set out in points 1, 2, 3, 4 and 7 of the first paragraph of Article 9 of Regulation (EU) No 1303/2013. Article 12 Outermost regions 1. Article 4 shall not apply to the specific additional allocation for the outermost regions. That allocation shall be used to offset the additional costs, linked to the special characteristics and constraints referred to in Article 349 TFEU, incurred in the outermost regions in supporting: (a) the thematic objectives set out in the first paragraph of Article 9 of Regulation (EU) No 1303/2013; (b) freight transport services and start-up aid for transport services; (c) operations linked to storage constraints, the excessive size and maintenance of production tools, and the lack of human capital in the local market. 2. The specific additional allocation referred to in paragraph 1 may also be used to help finance operating aid and expenditure covering public service obligations and contracts in the outermost regions. 3. The amount to which the rate of co-financing applies shall be proportionate to the additional costs, referred to in paragraph 1, incurred by the beneficiary, only in the case of operating aid and expenditure covering public service obligations and contracts, but may cover the total eligible costs in the case of expenditure for investment. 4. The specific additional allocation referred to in paragraph 1 of this Article shall not be used to support: (a) operations involving products listed in Annex I to the TFEU; (b) aid for the transport of persons authorised under point (a) of Article 107(2) TFEU; (c) tax exemptions and exemption of social charges. 5. By way of derogation from points (a) and (b) of Article 3(1), the ERDF may support productive investment in enterprises in the outermost regions, irrespective of the size of those enterprises. 6. Article 4 shall not apply to the ERDF part of the envelope allocated to Mayotte as an outermost region within the meaning of Article 349 TFEU, and at least 50 % of that ERDF part shall be allocated to the thematic objectives set out in points 1, 2, 3, 4 and 6 of the first paragraph of Article 9 of Regulation (EU) No 1303 /2013. CHAPTER III Final provisions Article 13 Transitional provisions 1. This Regulation shall not affect either the continuation or modification, including the total or partial cancellation of assistance approved by the Commission on the basis of Regulation (EC) No 1080/2006 or any other legislation applying to that assistance on 31 December 2013. That Regulation or such other applicable legislation shall consequently continue to apply after 31 December 2013 to that assistance or the operations concerned until their closure. For the purposes of this paragraph assistance shall cover operational programmes and major projects. 2. Applications to receive assistance made or approved under Regulation (EC) No 1080/2006 shall remain valid. Article 14 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 6(4) and 8(3) shall be conferred on the Commission from 21 December 2013 until 31 December 2020. 3. The delegation of power referred to in Articles 6(4) and 8(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 6(4) and 8(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. Article 15 Repeal Without prejudice to Article 13 of this Regulation, Regulation (EC) No 1080/2006 is hereby repealed with effect from 1 January 2014. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex II. Article 16 Review The European Parliament and the Council shall review this Regulation by 31 December 2020, in accordance with Article 177 TFEU. Article 17 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. Article 12(6) shall apply with effect from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 December 2013. For the European Parliament The President M. SCHULZ For the Council The President R. \u0160AD\u017dIUS (1) OJ C 191, 29.6.2012, p. 44. (2) OJ C 225, 27.7.2012, p. 114. (3) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Regulation (EC) No 1083/2006 (See page 320 of this Official Journal). (4) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32). (5) Regulation (EU) No 1300/2013 of the European Parliament and of the Council of 17 December 2013 on the Cohesion Fund and repealing Council Regulation (EC) No 1084/2006 (See page 281 of this Official Journal). (6) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (7) Council Regulation (EC) No 994/98 of 7 May 1998 on the application of Articles 92 and 93 of the Treaty establishing the European Community to certain categories of horizontal State aid (OJ L 142, 14.5.1998, p. 1). (8) European Council Decision 2012/419/EU of 11 July 2012 amending the status of Mayotte with regard to the European Union (OJ L 204, 31.7.2012, p. 131). (9) Regulation (EC) No 1080/2006 of the European Parliament and the Council of 5 July 2006 on the European Regional Development Fund and repealing Regulation (EC) No 1783/1999 (OJ L 210, 31.7.2006, p. 1). (10) Regulation (EU) No 1304/2013 of the European Parliament and of the Council of 17 December 2013 on the European Social Fund and repealing Council Regulation (EC) No 1081/2006 (See page 470 of this Official Journal). (11) Regulation (EU) No 1299/2013 of the European Parliament and of the Council of 17 December 2013 on specific provisions for the support from the European Regional Development Fund to the European territorial cooperation goal (See page 259 of this Official Journal). ANNEX I COMMON OUTPUT INDICATORS FOR ERDF SUPPORT UNDER THE INVESTMENT FOR GROWTH AND JOBS GOAL (ARTICLE 6) UNIT NAME Productive investment enterprises Number of enterprises receiving support enterprises Number of enterprises receiving grants enterprises Number of enterprises receiving financial support other than grants enterprises Number of enterprises receiving non-financial support enterprises Number of new enterprises supported EUR Private investment matching public support to enterprises (grants) EUR Private investment matching public support to enterprises (non-grants) full time equivalents Employment increase in supported enterprises Sustainable tourism visits/year Increase in expected number of visits to supported sites of cultural and natural heritage and attractions ICT Infrastructure households Additional households with broadband access of at least 30 Mbps Transport Railway kilometres Total length of new railway lines of which: TEN-T kilometres Total length of reconstructed or upgraded railway lines of which: TEN-T Roads kilometres Total length of newly built roads of which: TEN-T kilometres Total length of reconstructed or upgraded roads of which: TEN-T Urban transport kilometres Total length of new or improved tram and metro lines Inland waterways kilometres Total length of new or improved inland waterways Environment Solid waste tonnes/year Additional waste recycling capacity Water supply persons Additional population served by improved water supply Wastewater treatment population equivalent Additional population served by improved wastewater treatment Risk prevention and management persons Population benefiting from flood protection measures persons Population benefiting from forest fire protection measures Land rehabilitation hectares Total surface area of rehabilitated land Nature and biodiversity hectares Surface area of habitats supported in order to attain a better conservation status Research, Innovation full-time equivalents Number of new researchers in supported entities full-time equivalents Number of researchers working in improved research infrastructure facilities enterprises Number of enterprises cooperating with research institutions EUR Private investment matching public support in innovation or R&D projects enterprises Number of enterprises supported to introduce new to the market products enterprises Number of enterprises supported to introduce new to the firm products Energy and Climate change Renewables MW Additional capacity of renewable energy production Energy efficiency households Number of households with improved energy consumption classification kWh/year Decrease of annual primary energy consumption of public buildings users Number of additional energy users connected to smart grids GHG reduction tonnes of CO2eq Estimated annual decrease of GHG Social infrastructure Childcare & education persons Capacity of supported childcare or education infrastructure Health persons Population covered by improved health services Urban Development specific indicators persons Population living in areas with integrated urban development strategies square metres Open space created or rehabilitated in urban areas square metres Public or commercial buildings built or renovated in urban areas housing units Rehabilitated housing in urban areas ANNEX II CORRELATION TABLE Regulation (EC) No 1080/2006 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 Article 3 \u2014 Article 4 Article 4 Article 5 Article 5 Article 5 Article 6 \u2014 Article 7 \u2014 \u2014 Article 6 Article 8 Article 7 \u2014 Article 8 \u2014 Article 9 Article 9 \u2014 Article 10 Article 10 \u2014 Article 11 Article 11 Article 12 Article 12 \u2014 Article 13 \u2014 Article 14 \u2014 Article 15 \u2014 Article 16 \u2014 Article 17 \u2014 Article 18 \u2014 Article 19 \u2014 Article 20 \u2014 Article 21 \u2014 Article 22 Article 13 \u2014 Article 14 Article 23 Article 15 Article 24 Article 16 Article 25 Article 17 Joint statement of the European Parliament and of the Council concerning the application of Article 6 of the ERDF Regulation, Article 15 of the ETC Regulation and Article 4 of the Cohesion Fund Regulation The European Parliament and the Council note the assurance provided by the Commission to the EU legislature that the common output indicators for the ERDF Regulation, the ETC Regulation and the Cohesion Fund Regulation to be included in an annex to, respectively, each regulation, are the outcome of a lengthy preparatory process involving the evaluation experts of both the Commission and the Member States and, in principle, are expected to remain stable.", "summary": "European Regional Development Fund (2014-2020) European Regional Development Fund (2014-2020) SUMMARY OF: Regulation (EU) No 1301/2013 on the European Regional Development Fund and on specific rules about the investment for growth and jobs goal WHAT IS THE AIM OF THE REGULATION? It sets up the European Regional Development Fund (ERDF) for the period 2014-2020. The ERDF aims to promote the EU\u2019s harmonious, balanced and sustainable development by correcting some of the differences in levels of development between its regions. The regulation has been amended three times by: amending Regulation (EU, Euratom) 2018/1046 \u2014 the EU\u2019s financial regulation (see summary) which sets out the rules for drawing up and implementing the EU budget; andamending Regulation (EU) 2020/460, adopted following the COVID-19 outbreak, which contains specific measures to mobilise investments in EU countries\u2019 healthcare systems and in other sectors of their economies (Coronavirus Response Investment Initiative), andamending Regulation (EU) 2020/558, adopted following the COVID-19 outbreak, and containing exceptional flexibility for the use of the European Structural and Investments Funds (ESI Funds). KEY POINTS Eligibility All regions in EU countries are eligible but the aid granted depends on EU priorities and the type of region. Key themes The ERDF concentrates its investments on 4 key themes: innovation and research; information and communication technologies (ICT); support for small and medium-sized enterprises (SMEs); promoting a low-carbon economy. Types of investment in SMEs to create and safeguard sustainable jobs, in all types of enterprise in the fields of innovation and research, the low-carbon economy, as well as ICT where SMEs are involved, in infrastructure providing basic services in energy, environment, transport, and ICT, but also in social, health and educational infrastructure, working capital in SMEs where necessary as a temporary measure to provide an effective response to a public health crisis (following the outbreak of the COVID-19 pandemic), and in the development of endogenous potential. Overall budget The budget for 2014-2020 is over \u20ac185 billion. Policy and budget priorities The 4 key themes listed above are very significant for the allocation of ERDF funding which varies depending on the category of region. The regions are defined in terms of their GDP expressed as a percentage of an EU average: more developed regions: GDP more than 90%transition regions: GDP 75%-90%less developed regions: GDP less than 75% In more developed regions, (transition regions), (less developed regions), at least 80% (60%) (50%) of total ERDF funds in each country must be allocated to 2 or more of the 4 key themes, namely innovation and research, SMEs, ICT and a low-carbon economy; because of its importance, at least 20% (15%) (12%) of total ERDF funds in each country must be channelled specifically towards low-carbon economy projects. A minimum of 5% of ERDF funding is earmarked for sustainable urban development. An urban development network is to be set up at EU level to promote networking and exchange of experience on sustainable urban development. Implementation ERDF is implemented at national level by means of 7-year programmes as part of a Partnership Agreement between the EU country and the EU which involves the 5 European Structural and Investment Funds (ESI Funds): ERDF,European Social Fund (ESF),Cohesion Fund,European Maritime and Fisheries Fund (EMFF) andEuropean Agricultural Fund for Rural Development (EAFRD). This agreement is prepared by each EU country with the involvement of partners representing regional and local public authorities, as well as a wide range of social, economic, environmental and other interests. Coronavirus Response Investment Initiative The Coronavirus Investment Initiative, introduced by Regulation (EU) 2020/460, offers EU countries access to \u20ac37 billion from the ESI Funds to strengthen health systems and support small and medium-sized enterprises, short-time working schemes and community-based services. Coronavirus special measures: more flexibility in the use of ESI fund Amending Regulation (EU) 2020/558 allows EU countries to transfer resources between the European Regional Development Fund, the European Social Fund and the Cohesion Fund, between the different categories of regions and between the 3 funds\u2019 specific priority areas. From 1 July 2020 to 30 June 2021, cohesion policy programmes related to COVID-19 can be financed exceptionally through 100% EU funding during the accounting year. The measures also simplify programme approval to speed up implementation, make financial instruments easier to use and simplify audits. FROM WHEN DOES THE REGULATION APPLY? It has applied since 21 December 2013. BACKGROUND For more information, see: European Regional Development Fund (European Commission) Cohesion policy action against coronavirus (European Commission). MAIN DOCUMENT Regulation (EU) No 1301/2013 of the European Parliament and of the Council of 17 December 2013 on the European Regional Development Fund and on specific provisions concerning the Investment for growth and jobs goal and repealing Regulation (EC) No 1080/2006 (OJ L 347, 20.12.2013, pp. 289-302) Successive amendment to Regulation (EU) No 1301/2013 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2017/2056 of 22 August 2017 amending Delegated Regulation (EU) No 522/2014 supplementing Regulation (EU) No 1301/2013 of the European Parliament and of the Council with regard to the detailed rules concerning the principles for the selection and management of innovative actions in the area of sustainable urban development to be supported by the European Regional Development Fund (OJ L 294, 11.11.2017, p. 26) Commission Delegated Regulation (EU) No 522/2014 of 11 March 2014 supplementing Regulation (EU) No 1301/2013 of the European Parliament and of the Council with regard to the detailed rules concerning the principles for the selection and management of innovative actions in the area of sustainable urban development to be supported by the European Regional Development Fund (OJ L 148, 20.5.2014, pp. 1-3) See consolidated version. Commission Implementing Decision 2014/99/EU of 18 February 2014 setting out the list of regions eligible for funding from the European Regional Development Fund and the European Social Fund and of Member States eligible for funding from the Cohesion Fund for the period 2014-2020 (OJ L 50, 20.2.2014, pp. 22-34) See consolidated version. last update 07.07.2020"}
{"article": "20.12.2013 EN Official Journal of the European Union L 347/259 REGULATION (EU) No 1299/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2013 on specific provisions for the support from the European Regional Development Fund to the European territorial cooperation goal THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 178 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure, Whereas: (1) Article 176 of the Treaty on the Functioning of the European Union (TFEU) provides that the European Regional Development Fund (ERDF) is intended to help to redress the main regional imbalances in the Union. Under that Article and the second and third paragraphs of Article 174 TFEU, the ERDF is to contribute to reducing disparities between the levels of development of the various regions and to reducing the backwardness of the least favoured regions, among which particular attention is to be paid to rural areas, areas affected by industrial transition, and regions which suffer from severe and permanent natural or demographic handicaps such as the northernmost regions with very low population density and island, cross-border and mountain regions. (2) Regulation (EU) No 1303/2013 of the European Parliament and of the Council (3) sets out provisions common to the ERDF, the European Social Fund (ESF), the Cohesion Fund, the European Agricultural Fund for Rural Development (EAFRD) and the European Maritime and Fisheries Fund (EMFF). Regulation (EU) No 1301/2013 of the European Parliament and of the Council (4) sets out specific provisions concerning the type of activities which can be supported by the ERDF, and defines the goals for those activities. Those Regulations are not fully adapted to the specific needs of the European territorial cooperation goal, where at least two Member States or one Member State and a third country cooperate. It is therefore necessary to lay down provisions specific to the European territorial cooperation goal concerning scope, geographical coverage, financial resources, thematic concentration and investment priorities, programming, monitoring and evaluation, technical assistance, eligibility, management, control and designation, participation of third countries, and financial management. (3) In order to increase the added value of the Union's cohesion policy, specific provisions should be aimed at achieving considerable simplification for all those involved: beneficiaries, programme authorities, authorities in participating Member States, at local, regional or national level, as appropriate, and third countries, as well as the Commission. (4) In order to support the harmonious development of the Union's territory at different levels, the ERDF should support cross-border, transnational and interregional cooperation under the European territorial cooperation goal. (5) Cross-border cooperation should aim to tackle common challenges identified jointly in the border regions, such as: poor accessibility, especially in relation to information and communication technologies (ICT) connectivity and transport infrastructure, declining local industries, an inappropriate business environment, lack of networks among local and regional administrations, low levels of research and innovation and take-up of ICT, environmental pollution, risk prevention, negative attitudes towards neighbouring country citizens and aim to exploit the untapped growth potential in border areas (development of cross-border research and innovation facilities and clusters, cross-border labour market integration, cooperation among education providers, including universities or between health centres), while enhancing the cooperation process for the purpose of the overall harmonious development of the Union. (6) Transnational cooperation should aim to strengthen cooperation by means of actions conducive to integrated territorial development linked to the Union's cohesion policy priorities, and should also include maritime cross-border cooperation not covered by cross-border cooperation programmes. (7) Interregional cooperation should aim to reinforce the effectiveness of cohesion policy by encouraging exchange of experience between regions on thematic objectives and urban development, including urban-rural linkages, to improve implementation of territorial cooperation programmes and actions as well as promoting analysis of development trends in the area of territorial cohesion through studies, data collection and other measures. The exchange of experience on thematic objectives should enhance design and implementation, principally of operational programmes under the Investment for growth and jobs goal, but also, where appropriate, of programmes under the European territorial cooperation goal, including the fostering of mutually beneficial cooperation between innovative research-intensive clusters and exchanges between researchers and research institutions in both developed and less developed regions, taking into consideration the experience of 'Regions of Knowledge' and 'Research potential in Convergence and Outermost regions' under the Seventh Framework Programme for Research. (8) Objective criteria for designating eligible regions and areas should be fixed. To this end, the identification of eligible regions and areas at Union level should be based on the common system of classification of the regions established by Regulation (EC) No 1059/2003 of the European Parliament and of the Council (5). (9) Cross-border cooperation should support regions located on land or maritime borders. Based on experience from previous programming periods, the Commission should define the list of cross-border areas that are to receive support under cross-border cooperation programmes in a simpler way, by cooperation programme. In drawing up that list, the Commission should take into account adjustments needed to ensure coherence, in particular with regard to land and maritime borders, and continuity of programme areas established for the 2007-2013 programming period. Such adjustments could involve reducing or enlarging existing programme areas or the number of cross-border cooperation programmes, while allowing for the possibility of geographical overlap. (10) The Commission should define transnational cooperation areas having regard to actions needed to promote integrated territorial development. In defining those areas, the Commission should take into account the experience obtained in previous programmes and, where appropriate, macro-regional and sea-basin strategies. (11) To ensure that all regions in the Union can benefit from the exchange of experience and good practices, interregional cooperation programmes should cover the whole Union. (12) It is necessary to continue supporting or, as appropriate, to establish cross-border, transnational and interregional cooperation with the Union's neighbouring third countries, as such coopearation is an important regional development policy tool and should benefit the regions of the Member States which border third countries. To that effect, the ERDF should contribute to the cross-border and sea-basin programmes established under the European Neighbourhood Instrument (ENI) pursuant to a future Union legislative act concerning the European Neighbourhood Instrument for the period 2014\u20132020 (the 'ENI legislative act') and the Instrument for Pre-Accession Assistance (IPA II) pursuant to a future Union legislative act concerning the Pre-Accession Assistance for the period 2014-2020 (the 'IPA II legislative act'). (13) Apart from interventions on external borders supported by external policy instruments of the Union covering border regions inside and outside the Union, it should be possible for cooperation programmes supported by the ERDF to cover regions both inside and, in certain cases, outside the Union, where the regions outside the Union are not covered by external policy instruments either because they are not defined as a beneficiary country or because such external cooperation programmes cannot be set up. It is necessary, however, to ensure that the support from the ERDF for operations implemented in the territory of third countries should serve primarily for the benefit of the regions of the Union. Within those constraints, the Commission should, when drawing up the lists of cross-border and transnational programme areas, cover regions in third countries as well. (14) It is necessary to set out the resources allocated to each of the different components of the European territorial cooperation goal, while maintaining a significant concentration on cross-border cooperation, including each Member State's share of the global amounts for cross-border and transnational cooperation, the potential available to Member States concerning flexibility between those components, and securing sufficient funding levels for outermost regions' cooperation. (15) For the benefit of the regions of the Union, a mechanism to organise support from the ERDF to external policy instruments, such as the ENI and the IPA II, should be set up, including where external cooperation programmes cannot be adopted or have to be discontinued. That mechanism should seek to achieve optimal functioning and the maximum possible coordination between those instruments. (16) The major part of the ERDF funding for cross-border and transnational cooperation programmes should be concentrated on a limited number of thematic objectives in order to maximise the impact of cohesion policy across the Union. However, the concentration under the interregional cooperation programme on thematic objectives should be reflected in the aim of each operation rather than in a limitation of the number of thematic objectives, in order to get the most out of interregional cooperation for the reinforcement of the effectiveness of cohesion policy principally under the Investment for growth and jobs goal and also, where appropriate, the European territorial cooperation goal. In the case of other interregional cooperation programmes, the thematic concentration should derive from their specific scope. (17) In order to deliver on the targets and objectives set out in the Union strategy for smart, sustainable and inclusive growth, the ERDF should contribute under the European territorial cooperation goal to the thematic objectives of developing an economy based on knowledge, research and innovation, including through the fostering of cooperation between businesses, particularly between SMEs, and through the promotion of the establishment of systems for cross-border information exchange in the area of ICT; promoting a greener, more resource-efficient and competitive economy, including through the promotion of sustainable cross-border mobility; fostering high employment that results in social and territorial cohesion, including through activities supporting sustainable tourism, culture and natural heritage as part of a territorial strategy aimed at achieving employment-friendly growth; and developing administrative capacity. However, the list of the investment priorities under the different thematic objectives should be adapted to the specific needs of the European territorial cooperation goal, by providing for additional investment priorities allowing in particular for the continuation under cross-border cooperation of legal and administrative cooperation, cooperation between citizens and institutions, and of cooperation in the fields of employment, training, integration of communities and social inclusion in a cross-border perspective, and by the development and coordination of macro-regional and sea-basin strategies under transnational cooperation. In addition, specific or additional investment priorities should be set out for certain interregional cooperation programmes to reflect their specific activities. (18) Within the thematic objective of promoting social inclusion and combating poverty and taking into account its practical importance, it is necessary to ensure that, in the case of the PEACE cross-border programme between Northern Ireland and the border counties of Ireland in support of peace and reconciliation, the ERDF should also contribute to promoting social and economic stability in the regions concerned, in particular through actions to promote cohesion between communities. Given the specificities of that cross-border programme, certain rules on selection of operations in this Regulation should not apply to that cross-border programme. (19) It is necessary to adapt the content requirements of cooperation programmes under the European territorial cooperation goal to their specific needs. Those requirements should therefore also cover aspects necessary for effective implementation on the territory of participating Member States, such as those concerning the bodies responsible for audit and control, the procedure for setting up a joint secretariat, and the allocation of liabilities in the case of financial corrections. Where Member States and regions participate in macro-regional and sea-basin strategies, the cooperation programmes concerned should set out how interventions could contribute to such strategies. In addition, due to the horizontal character of interregional cooperation programmes, the content of such cooperation programmes should be adapted, especially as regards the definition of the beneficiary or beneficiaries under the current INTERACT and ESPON programmes. (20) In order to strengthen the co-ordination of ERDF support for cooperation programmes, adopted under this Regulation, involving the outermost regions with possible complementary financing from the European Development Fund (EDF), the ENI, the IPA II, and the European Investment Bank (EIB), Member States and third countries or overseas countries or territories (the latter hereinafter referred to as 'territories') participating in such cooperation programmes should set out rules for coordination mechanisms in those programmes. (21) It is appropriate to involve third countries or territories in the preparatory process of cooperation programmes, where they have accepted the invitation to participate in such programmes. Special procedures should be established in this Regulation for such involvement. By way of derogation from the standard procedure, where cooperation programmes involve outermost regions and third countries or territories, the participating Member States should consult the respective third countries or territories before submitting the programmes to the Commission. In order to make the involvement of third countries or territories in cooperation programmes more effective and pragmatic, it should also be possible to have the agreements to the contents of the cooperation programmes and the possible contribution of the third countries or territories, expressed in the formally approved minutes of the consultation meetings with such third countries or territories, or of the deliberations of the regional cooperation organisations. Taking into account the principles of shared management and of simplification, the approval procedure for cooperation programmes should be such that the Commission approves only the core elements of the cooperation programmes, while the other elements should be approved by the participating Member State or Member States. For the sake of legal certainty and transparency, it is necessary to ensure that, in cases where the participating Member State or Member States amend an element of a cooperation programme which is not subject to approval by the Commission, the managing authority for that programme notifies such an amending decision to the Commission within one month of the date of that amending decision. (22) In line with the Union strategy for smart, sustainable and inclusive growth, the European Structural and Investment Funds should provide a more integrated and inclusive approach to tackling local problems. In order to strengthen such an approach, support from the ERDF in border regions should be coordinated with support from the EAFRD and the EMFF and should, where appropriate, involve European groupings of territorial cooperation (EGTCs) set up under Regulation (EU) No 1302/2013 of the European Parliament and of the Council (6) where local development is one of their objectives. (23) Based on the experience from the 2007-2013 programming period, the conditions for selection of operations should be clarified and strengthened in order to ensure selection of only genuinely joint operations. Due to the particular context and specificities of cooperation programmes between outermost regions and third countries or territories, lightened cooperation conditions in terms of processing operations under those programmes should be established and adapted. The notion of sole beneficiaries should be defined and such beneficiaries should be permitted to carry out cooperation operations by themselves. (24) The responsibilities of lead beneficiaries, retaining overall responsibility for the implementation of an operation, should be specified. (25) The requirements for implementation reports should be adapted to the cooperation context and reflect the programme implementation cycle. In the interests of sound management, it should be possible for the annual review to be carried out in writing. (26) In accordance with Regulation (EU) No 1303/2013 the managing authority should ensure that evaluations of cooperation programmes are carried out on the basis of the evaluation plan and include evaluations to assess the effectiveness, efficiency and impact of those programmes. At least once during the programming period, an evaluation should assess how the support provided has contributed to the achievement of objectives of the programme. Such evaluations should include information about any proposed adjustments during the programming period. (27) A common set of output indicators to facilitate the assessment of the progress of programme implementation, adapted to the specific character of cooperation programmes, should be set out in an Annex to this Regulation. Those indicators should be complemented by programme-specific result indicators and, where relevant, by programme specific output indicators. (28) Due to the involvement of more than one Member State, and the resulting higher administrative costs, in particular, in respect of controls and translation, the ceiling for technical assistance expenditure should be higher than that under the Investment for growth and jobs goal. In order to offset the higher administrative costs, Member States should be encouraged wherever possible to reduce the administrative burden with regard to the implementation of joint projects. In addition, cooperation programmes with limited ERDF support should receive a certain minimum amount for technical assistance which could be greater than 6 %, to ensure sufficient funding for effective technical assistance activities. (29) Due to the involvement of more than one Member State, the general rule laid down in Regulation (EU) No 1303 /2013, whereby each Member State is to adopt national rules on eligibility of expenditure, is not appropriate for the European territorial cooperation goal. Based on experience from the 2007-2013 programming period, a clear hierarchy of rules on eligibility of expenditure should be established with a strong move towards rules on eligibility of expenditure established at Union level or for a cooperation programme as a whole to avoid any possible contradictions or inconsistencies between different Regulations and between Regulations and national rules. In particular, the Commission should, based on experience from the 2007-2013 programming period, adopt rules on eligibility of expenditure for cost categories laid down in this Regulation. (30) Due to the frequent involvement of staff from more than one Member State in the implementation of operations, and given the number of operations for which staff costs is a significant element, a flat-rate for staff costs should be applied based on the other direct costs of cooperation operations, thus avoiding individual accounting for the management of such operations. (31) The rules on flexibility concerning the location of operations outside the programme area should be simplified. In addition, it is necessary to support and facilitate, through specific arrangements, effective cross-border, transnational and interregional cooperation with the Union's neighbouring third countries or territories where this is necessary to ensure that regions of the Member States are effectively assisted in their development. Accordingly, it is appropriate to authorise on an exceptional basis and under certain conditions support from the ERDF for operations located outside the Union part of the programme area and on the territory of neighbouring third countries where those operations are for the benefit of the regions of the Union. (32) Member States should be encouraged to assign the functions of the managing authority to an EGTC or to make such a grouping responsible for managing the part of a cooperation programme that relates to the territory covered by that EGTC. (33) The managing authority should set up a joint secretariat which should, inter alia, provide information to applicants for support, deal with project applications and assist beneficiaries in implementing their operations. (34) Managing authorities should be responsible for the functions laid down in Regulation (EU) No 1303 /2013, including for management verifications, in order to ensure uniform standards across the whole programme area. However, where an EGTC is designated as managing authority, such verifications should be carried out by or under the responsibility of the managing authority at least for those Member States and third countries or territories from which there are members participating in the EGTC, while controllers should only be used in the remaining Member States and third countries or territories. Even if no EGTC is designated, the managing authority should be authorised by the participating Member States to carry out verifications on the whole programme area. (35) Certifying authorities should be responsible for the certifying authority functions laid down in Regulation (EU) No 1303/2013. The Member States should be able to designate the managing authority to also carry out the functions of the certifying authority. (36) A single audit authority should be responsible for carrying out the audit authority functions laid down in Regulation (EU) No 1303/2013 in order to ensure uniform standards across the whole programme area. Where that is not possible, a group of auditors should be able to assist the programme audit authority. (37) In order to strengthen the Union's economic, social and territorial cohesion and to reinforce the effectiveness of its cohesion policy, third countries should be allowed to participate, through a contribution of IPA II and ENI resources, in transnational and interregional cooperation programmes. Operations co-financed under such programmes should, however, continue to pursue cohesion policy objectives, even if they are implemented, partly or in their entirety, outside the territory of the Union. In this context, the contribution to the objectives of the Union's external action remains merely incidental, as the centre of gravity of cooperation programmes should be determined by the thematic objectives and investment priorities of cohesion policy. In order to ensure effective participation by third countries in cooperation programmes that are managed in accordance with the shared management principle, programme implementation conditions should be set out in the cooperation programmes themselves and also, where necessary, in financing agreements, concluded between the Commission, the governments of each of the third countries and the Member State hosting the managing authority of the relevant cooperation programme. The programme implementation conditions should be consistent with applicable Union law and, where appropriate, with the provisions of national law of participating Member States relating to its application. (38) A clear chain of financial liability in respect of recovery for irregularities should be established from beneficiaries to lead beneficiary to the managing authority to the Commission. Provision should be made for liability of Member States where obtaining recovery is not possible. (39) Based on the experience from the 2007-2013 programming period, an explicit derogation should be established for the conversion of expenditure incurred in a currency other than the euro, by applying the monthly conversion rate at a date as close to the point in time of the expenditure as possible or in the month in which the expenditure was submitted for verification or in the month during which expenditure was reported to the lead beneficiary. Financing plans, reports and accounts concerning joint cooperation operations should only be submitted in euro to the joint secretariat, the programme authorities and the monitoring committee. The correctness of conversion should be verified. (40) In order to set out specific rules on amending common output indicators and on eligibility of expenditure, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the amendment of the list of common output indicators set out in the Annex to this Regulation and in respect of specific rules on eligibility of expenditure for cooperation programmes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (41) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of the lists of cross-border areas, and of transnational areas, of a list of all cooperation programmes and of the global amount from the ERDF support for each cooperation programme, of the nomenclature concerning categories of intervention and of the models for cooperation programmes and implementation reports. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (7). (42) Implementing powers should be conferred on the Commission to adopt decisions approving certain elements of the cooperation programmes and any subsequent amendments to those elements. (43) This Regulation should not affect either the continuation or modification of assistance approved by the Commission on the basis of Regulation (EC) No 1080/2006 of the European Parliament and of the Council (8) or any other legislation applying to that assistance on 31 December 2013. That Regulation or such other applicable legislation should consequently continue to apply after 31 December 2013 to that assistance or the operations concerned until their closure. Applications to receive assistance made or approved under Regulation (EC) No 1080/2006 should remain valid. (44) Since the objective of this Regulation, namely to reinforce economic, social and territorial cohesion by redressing the main regional imbalances in the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of the extent of the disparities between the levels of development of the various regions and the backwardness of the least favoured regions and the limit on the financial resources of the Member States and regions, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (45) In order to allow for the prompt application of the measures provided for in this Regulation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject matter and scope 1. This Regulation establishes the scope of the ERDF with regard to the European territorial cooperation goal and lays down specific provisions concerning that goal. 2. This Regulation defines, for the European territorial cooperation goal, the priority objectives and organisation of the ERDF, the criteria for Member States and regions to be eligible for support from the ERDF, the financial resources available for support from the ERDF, and the criteria for their allocation. It also lays down the provisions necessary to ensure effective implementation, monitoring, financial management and control of operational programmes under the European territorial cooperation goal (\"cooperation programmes\"), including when third countries participate in such cooperation programmes. 3. Regulation (EU) No 1303/2013 and Chapter I of Regulation (EU) No 1301/2013 shall apply to the European territorial cooperation goal and to cooperation programmes thereunder, except where specifically provided for under this Regulation or where those provisions can only apply to the Investment for growth and jobs goal. Article 2 Components of the European territorial cooperation goal Under the European territorial cooperation goal, the ERDF shall support the following components: (1) cross-border cooperation between adjacent regions to promote integrated regional development between neighbouring land and maritime border regions in two or more Member States or between neighbouring border regions in at least one Member State and one third country on external borders of the Union other than those covered by programmes under the external financial instruments of the Union; (2) transnational cooperation over larger transnational territories, involving national, regional and local partners and also covering maritime cross-border cooperation in cases not covered by cross-border cooperation, with a view to achieving a higher degree of territorial integration of those territories; (3) interregional cooperation to reinforce the effectiveness of cohesion policy by promoting: (a) exchange of experience focusing on thematic objectives among partners throughout the Union, including in relation to the development of regions referred to in Article 174 TFEU on the identification and dissemination of good practices with a view to their transfer principally to operational programmes under the Investment for growth and jobs goal but also, where relevant, to cooperation programmes; (b) exchange of experience concerning the identification, transfer and dissemination of good practices in relation to sustainable urban development, including urban-rural linkages; (c) exchange of experience concerning the identification, transfer and dissemination of good practices and innovative approaches in relation to the implementation of cooperation programmes and actions as well as to the use of EGTCs; (d) analysis of development trends in relation to the aims of territorial cohesion, including territorial aspects of economic and social cohesion, and harmonious development of Union territory through studies, data collection and other measures. Article 3 Geographical coverage 1. For cross-border cooperation, the regions to be supported shall be the NUTS level 3 regions of the Union along all internal and external land borders other than those covered by programmes under the external financial instruments of the Union, and all NUTS level 3 regions of the Union along maritime borders separated by a maximum of 150 km, without prejudice to potential adjustments needed to ensure the coherence and continuity of cooperation programme areas established for the 2007-2013 programming period. The Commission shall adopt a decision, by means of implementing acts, setting out the list of cross-border areas to receive support, broken down by cooperation programme. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 150(2) of Regulation (EU) No 1303/2013. That list shall also specify those NUTS level 3 regions of the Union taken into account for the ERDF allocation for cross-border cooperation at all internal borders, and those external borders covered by the external financial instruments of the Union, such as the ENI pursuant to the ENI legislative act and the IPA II pursuant to the IPA II legislative act. When submitting draft cross-border cooperation programmes, Member States, in duly justified cases, and, in order to ensure the coherence of cross-border areas, may request that NUTS level 3 regions other than those listed in the decision referred to in the second subparagraph, are added to a given cross-border cooperation area. At the request of the Member State or Member States concerned, in order to facilitate cross border cooperation on maritime borders for outermost regions, and without prejudice to the provisions of the first subparagraph, the Commission may include, in the decision referred to in the second subparagraph, NUTS level 3 regions in outermost regions along maritime borders separated by more than 150 km as cross-border areas which may receive support from the corresponding allocation of those Member States. 2. Without prejudice to Article 20(2) and (3), cross-border cooperation programmes may cover regions in Norway and Switzerland and also cover Liechtenstein, Andorra, Monaco and San Marino and third countries or territories neighbouring outermost regions, all of which shall be equivalent to NUTS level 3 regions. 3. For transnational cooperation, the Commission shall adopt a decision, by means of implementing acts, setting out the list of transnational areas to receive support, broken down by cooperation programme and covering NUTS level 2 regions, while ensuring the continuity of such cooperation in larger coherent areas based on previous programmes, taking account, where appropriate, of macro-regional and sea-basin strategies. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 150(2) of Regulation (EU) No 1303/2013. When submitting draft transnational cooperation programmes, Member States may request that additional NUTS level 2 regions located adjacent to the regions listed in the decision referred to in the first subparagraph are added to a given transnational cooperation area. Member States shall give reasons for such a request. 4. Without prejudice to Article 20(2) and (3), transnational cooperation programmes may cover regions in both of the following third countries or territories: (a) the third countries or territories listed or referred to in paragraph 2 of this Article; (b) the Faroe Islands and Greenland. Without prejudice to Article 20(2) and (3), transnational cooperation programmes may also cover regions in third countries covered by the external financial instruments of the Union, such as the ENI pursuant to the ENI legislative act, including the relevant regions of the Russian Federation, and the IPA II pursuant to the IPA II legislative act. Annual appropriations corresponding to the support of the ENI and IPA II to those programmes shall be made available, provided that the programmes adequately address the relevant external cooperation objectives. Such regions shall be equivalent to NUTS level 2 regions. 5. For interregional cooperation, support from the ERDF shall cover the entire territory of the Union. Without prejudice to Article 20(2) and (3), interregional cooperation programmes may cover the whole or part of the third countries or territories referred to in points (a) and (b) of the first subparagraph of paragraph 4 of this Article. 6. For information purposes, regions of third countries or territories referred to in paragraphs 2 and 4 shall be mentioned in the lists referred to in paragraphs 1 and 3. 7. In duly justified cases, in order to increase the efficiency of programme implementation, the outermost regions may, in a single programme for territorial cooperation, combine the amounts of the ERDF allocated for cross-border and transnational cooperation, including the additional allocation provided for under Article 4(2), while complying with the applicable rules for each of those allocations. Article 4 Resources for European territorial cooperation goal 1. Resources for the European territorial cooperation goal shall amount to 2,75 % of the global resources available for budgetary commitment from the ERDF, ESF and the Cohesion Fund for the 2014-2020 programming period and set out in Article 91(1) of Regulation (EU) No 1303/2013 (i.e., a total of EUR 8 948 259 330) and shall be allocated as follows: (a) 74,05 % (i.e., a total of EUR 6 626 631 760) for cross-border cooperation; (b) 20,36 % (i.e., a total of EUR 1 821 627 570) for transnational cooperation; (c) 5,59 % (i.e., a total of EUR 500 000 000) for interregional cooperation. 2. For programmes under the European territorial cooperation goal, the outermost regions shall be allocated not less than 150 % of the ERDF support they received in the 2007-2013 programming period for cooperation programmes. In addition, an amount of EUR 50 000 000 from the allocation for interregional cooperation shall be set aside for outermost regions' cooperation. Concerning thematic concentration, Article 6(1) shall apply to that additional allocation. 3. The Commission shall communicate to each Member State its share of the global amounts for cross-border and transnational cooperation as referred to in points (a) and (b) of paragraph 1, broken down by year. Population size in the areas referred to in the second subparagraph of Article 3(1) and the first subparagraph of Article 3(3) shall be used as the criterion for the breakdown by Member State. Based on the amounts communicated pursuant to the first subparagraph, each Member State shall inform the Commission whether, and how, it has used the transfer option provided for in Article 5 and the resulting distribution of funds among the cross-border and transnational programmes in which the Member State participates. The Commission shall, on the basis of the information provided by Member States, adopt a decision, by means of implementing acts, setting out a list of all cooperation programmes and indicating the global amount of the total ERDF support for each programme. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 150(2) of Regulation (EU) No 1303/2013 4. The contribution from the ERDF to cross-border and sea-basin programmes under the ENI and to the cross-border programmes under the IPA II shall be established by the Commission and the Member States concerned. The ERDF contribution established for each Member State shall not subsequently be reallocated between the Member States concerned. 5. Support from the ERDF to individual cross-border and sea-basin programmes under the ENI and to the cross-border programmes under the IPA II shall be granted provided that at least equivalent amounts are provided by the ENI and the IPA II. That equivalence shall be subject to a maximum amount set out in the ENI legislative act or the IPA II legislative act. 6. The annual appropriations corresponding to the support from the ERDF to cross-border and sea-basin programmes under the ENI and to the cross-border programmes under the IPA II shall be entered in the relevant budget lines of those instruments for the 2014 budgetary exercise. 7. In 2015 and 2016, the annual contribution from the ERDF to the programmes under the ENI and the IPA II, for which no programme has been submitted to the Commission by 30 June under the cross-border and sea-basin programmes under the ENI, and under the cross-border programmes under the IPA II, and which has not been re-allocated to another programme submitted under the same category of external cooperation programmes, shall be allocated to the internal cross-border cooperation programmes under point (a) of paragraph 1 in which the Member State or Member States concerned participates or participate. If by 30 June 2017, there are still cross-border and sea-basin programmes under the ENI and cross-border programmes under the IPA II which have not been submitted to the Commission, the entire contribution from the ERDF referred to in paragraph 4 to those programmes for the remaining years up to 2020, which has not been re-allocated to another adopted programme under the same category of external cooperation programmes, shall be allocated to the internal cross-border cooperation programmes under point (a) of paragraph 1 in which the Member State or Member States concerned participates or participate. 8. Any cross-border and sea basin programmes, referred to in paragraph 4, adopted by the Commission shall be discontinued, or the allocation to the programmes shall be reduced, in accordance with the applicable rules and procedures, in particular if: (a) none of the partner countries covered by the programme have signed the relevant financing agreement by the deadline set out in accordance with the ENI legislative act or the IPA II legislative act; or (b) the programme cannot be implemented as planned due to problems in relations between the participating countries. In such cases, the contribution from the ERDF referred to in paragraph 4 corresponding to annual instalments not yet committed, or annual instalments committed and de-committed totally or partially during the same budgetary year, which have not been re-allocated to another programme of the same category of external cooperation programmes, shall be allocated to the internal cross-border cooperation programmes under point (a) of paragraph 1 in which the Member State or Member States concerned participates or participate, at its or their request. 9. The Commission shall provide an annual summary of the financial implementation of cross-border and sea-basin programmes under the ENI, and of cross-border programmes under the IPA II, to which the ERDF contributes in accordance with this Article, to the Committee established under Article 150(1) of Regulation (EU) No 1303/2013. Article 5 Transfer option Each Member State may transfer up to 15 % of its financial allocation for each of the components referred to in points (a) and (b) of Article 4(1) from one of those components to the other. CHAPTER II Thematic concentration and investment priorities Article 6 Thematic concentration 1. At least 80 % of the ERDF allocation to each cross-border cooperation and transnational programme shall be concentrated on a maximum of four of the thematic objectives set out in the first paragraph of Article 9 of Regulation (EU) No 1303/2013. 2. All of the thematic objectives set out in the first paragraph of Article 9 of Regulation (EU) No 1303 /2013 may be selected for interregional cooperation referred to in point (3)(a) of Article 2 of this Regulation. Article 7 Investment priorities 1. The ERDF shall, within its scope as set out in Article 3 of Regulation (EU) No 1301 /2013, contribute to the thematic objectives set out in the first paragraph of Article 9 of Regulation (EU) No 1303 /2013 through joint action under cross-border, transnational and interregional cooperation programmes. In addition to the investment priorities set out in Article 5 of Regulation (EU) No 1301 /2013, the ERDF may also support the following investment priorities within the thematic objectives indicated for each European territorial cooperation component: (a) under cross-border cooperation: (i) promoting sustainable and quality employment and supporting labour mobility by integrating cross-border labour markets, including cross-border mobility, joint local employment initiatives, information and advisory services and joint training; (ii) promoting social inclusion, combating poverty and any discrimination by promoting gender equality, equal opportunities, and the integration of communities across borders; (iii) investing in education, training and vocational training for skills and lifelong learning by developing and implementing joint education, vocational training and training schemes; (iv) enhancing institutional capacity of public authorities and stakeholders and efficient public administration by promoting legal and administrative cooperation and cooperation between citizens and institutions; (b) under transnational cooperation: enhancing institutional capacity of public authorities and stakeholders and efficient public administration by developing and coordinating macro-regional and sea-basin strategies; (c) under interregional cooperation: enhancing institutional capacity of public authorities and stakeholders and efficient public administration by: (i) disseminating good practices and expertise and capitalising on the results of the exchange of experience in relation to sustainable urban development, including urban-rural linkages pursuant to point (3)(b) of Article 2. (ii) promoting the exchange of experience in order to reinforce the effectiveness of territorial cooperation programmes and actions as well as the use of EGTCs pursuant to point (3)(c) of Article 2; (iii) strengthening the evidence base in order to reinforce the effectiveness of cohesion policy and the achievement of the thematic objectives through the analysis of development trends pursuant to point (3)(d) of Article 2; 2. In the case of the PEACE cross-border programme and within the thematic objective of promoting social inclusion, combating poverty and any discrimination, the ERDF shall also contribute to promoting social and economic stability in the regions concerned, in particular through actions to promote cohesion between communities. CHAPTER III Programming Article 8 Content, adoption and amendment of cooperation programmes 1. A cooperation programme shall consist of priority axes. Without prejudice to Article 59 of Regulation (EU) No 1303/2013, a priority axis shall correspond to a thematic objective and comprise one or more of the investment priorities of that thematic objective in line with Articles 6 and 7 of this Regulation. Where appropriate, and in order to increase its impact and effectiveness through a thematically coherent integrated approach to pursuing the objectives of the Union strategy for smart, sustainable and inclusive growth, a priority axis may, in duly justified cases, combine one or more complementary investment priorities from different thematic objectives in order to achieve the maximum contribution to that priority axis. 2. A cooperation programme shall contribute to the Union strategy for smart, sustainable and inclusive growth and to the achievement of economic, social and territorial cohesion, and shall set out: (a) a justification for the choice of thematic objectives, corresponding investment priorities and financial allocations, having regard to the Common Strategic Framework set out in Annex I to Regulation (EU) No 1303/2013, based on an analysis of the needs within the programme area as a whole and the strategy chosen in response to such needs, addressing where appropriate missing links in cross-border infrastructure, taking into account the results of the ex-ante evaluation carried out in accordance with Article 55 of Regulation (EU) No 1303/2013; (b) for each priority axis other than technical assistance: (i) the investment priorities and corresponding specific objectives; (ii) in order to strengthen the result-orientation of the programming, the expected results for the specific objectives, and the corresponding result indicators, with a baseline value and a target value, where appropriate quantified, in accordance with Article 16; (iii) a description of the type and examples of actions to be supported under each investment priority and their expected contribution to the specific objectives referred to in point (i) including the guiding principles for the selection of operations and where appropriate, the identification of the main target groups, specific territories targeted, types of beneficiaries, the planned use of financial instruments, and major projects; (iv) the common and specific output indicators, including the quantified target value, which are expected to contribute to the results, in accordance with Article 16, for each investment priority; (v) identification of implementation steps and financial and output indicators, and where appropriate, result indicators, to be used as milestones and targets for the performance framework in accordance with Article 21(1) of Regulation (EU) No 1303/2013 and Annex II to that Regulation; (vi) where appropriate, a summary of the planned use of technical assistance including, where necessary, actions to reinforce the administrative capacity of authorities involved in the management and control of the programmes and beneficiaries and, where necessary, actions to enhance the administrative capacity of relevant partners to participate in the implementation of the programmes; (vii) the corresponding categories of intervention based on a nomenclature adopted by the Commission and an indicative breakdown of the programmed resources; (c) for each priority axis concerning technical assistance: (i) specific objectives; (ii) the expected results for each specific objective, and, where objectively justified given the content of the actions, the corresponding result indicators, with a baseline value and a target value, in accordance with Article 16; (iii) a description of actions to be supported and their expected contribution to the specific objectives referred to in point (i); (iv) the output indicators which are expected to contribute to the results; (v) the corresponding categories of intervention based on a nomenclature adopted by the Commission and an indicative breakdown of the programmed resources. Point (ii) shall not apply where the Union contribution to the priority axis or axes concerning technical assistance in a cooperation programme does not exceed EUR 15 000 000; (d) a financing plan containing the following tables (without any division per participating Member State): (i) a table specifying for each year, in accordance with the rules on co-financing rates laid down in Articles 60, 120 and 121 of Regulation (EU) No 1303/2013, the amount of the total financial appropriation envisaged for the support from the ERDF; (ii) a table specifying, for the whole programming period, for the cooperation programme and for each priority axis, the amount of the total financial appropriation of the support from the ERDF and the national co-financing. For priority axes, which combine investment priorities from different thematic objectives, the table shall specify the amount of total financial appropriation and the national co-financing for each of the corresponding thematic objectives. Where the national co-financing is made up of public and private co-financing, the table shall give the indicative breakdown between the public and the private components. It shall show, for information purposes, any contribution from third countries participating in the programme and the envisaged participation from the EIB; (e) a list of major projects for which the implementation is planned during the programming period. The Commission shall adopt implementing acts concerning the nomenclature referred to in points (b)(vii) and (c)(v) of the first subparagraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 150(3) of Regulation (EU) No 1303/2000. 3. Taking into account its content and objectives, a cooperation programme shall describe the integrated approach to territorial development, including in relation to regions and areas referred to in Article 174(3) TFEU, having regard to the Partnership Agreements of the participating Member States, and showing how that cooperation programme contributes to the accomplishment of its objectives and expected results, specifying, where appropriate, the following: (a) the approach to the use of community-led local development instruments and the principles for identifying the areas where it will be implemented; (b) the principles for identifying the urban areas where integrated actions for sustainable urban development are to be implemented and the indicative allocation of the ERDF support for such actions; (c) the approach to the use of the integrated territorial investment instrument referred to in Article 11, other than in cases covered by point (b), and their indicative financial allocation from each priority axis; (d) where Member States and regions participate in macro-regional strategies and sea basin strategies, the contribution of the planned interventions under the cooperation programme to those strategies, subject to the needs of the programme area as identified by the relevant Member States and taking into account, where applicable, the strategically important projects identified in those strategies. 4. The cooperation programme shall also identify: (a) the implementing provisions which: (i) identify the managing authority, the certifying authority, where appropriate, and the audit authority; (ii) identify the body or bodies designated to carry out control tasks; (iii) identify the body or bodies designated to be responsible for carrying out audit tasks; (iv) lay down the procedure for setting up the joint secretariat; (v) set out a summary description of the management and control arrangements; (vi) set out the apportionment of liabilities among the participating Member States in the event of financial corrections imposed by the managing authority or the Commission. (b) the body to which payments are to be made by the Commission; (c) the actions taken to involve the partners referred to in Article 5 of Regulation (EU) No 1303/2013 in the preparation of the cooperation programme, and the role of those partners in the preparation and implementation of the cooperation programme, including their involvement in the monitoring committee. 5. The cooperation programme shall also set out the following, having regard to the content of the Partnership Agreements and taking into account the institutional and legal framework of the Member States: (a) mechanisms to ensure effective coordination between the ERDF, the ESF, the Cohesion Fund, the EAFRD, the EMFF and other Union and national funding instruments, including the coordination and possible combination with the Connecting Europe Facility pursuant to Regulation (EU) No 1316/2013 of the European Parliament and of the Council (9), the ENI, the EDF, and the IPA II, as well as with the EIB, taking into account the provisions set out in Annex I to Regulation (EU) No 1303/2013 where Member States and third countries or territories participate in cooperation programmes that include the use of ERDF appropriations for outermost regions and resources from the EDF, coordination mechanisms at the appropriate level to facilitate effective coordination in the use of those appropriations and resources; (b) a summary of the assessment of the administrative burden on beneficiaries and, where necessary, the actions planned, accompanied by an indicative timeframe, to reduce the administrative burden. 6. Information required under point (a) of the first subparagraph of paragraph 2, point (b)(i) to (vii) of the first subparagraph of paragraph 2, paragraph 3 and point (a) of paragraph 5 shall be adapted to the specific character of cooperation programmes under point (3)(b), (c) and (d) of Article 2. Information required under point (e) of the first subpararaph of paragraph 2 and point (b) of paragraph 5 shall not be included in cooperation programmes under point (3)(c) and (d) of Article 2. 7. Each cooperation programme shall, where appropriate and subject to the relevant Member States' duly justified assessment of their relevance to the content and objectives of the programme, include a description of: (a) the specific actions to take into account environmental protection requirements, resource efficiency, climate change mitigation and adaptation, disaster resilience and risk prevention and risk management, in the selection of operations; (b) the specific actions to promote equal opportunities and prevent any discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation during the preparation, design and implementation of the cooperation programme and in particular in relation to access to funding, taking account of the needs of the various target groups at risk of such discrimination and in particular the requirements to ensure accessibility for persons with disabilities; (c) the contribution of the cooperation programme to the promotion of equality between men and women and, where appropriate, the arrangements to ensure the integration of gender perspective at programme and operation level. Points (a) and (b) of the first subparagraph shall not apply to cooperation programmes under point (3)(b), (c) and (d) of Article 2. 8. Cooperation programmes under point (3)(c) and (d) of Article 2 shall define the beneficiary or beneficiaries and may specify the granting procedure. 9. The participating Member States and, where they have accepted the invitation to participate in the cooperation programme, third countries or territories, where applicable, shall confirm, in writing, their agreement to the contents of a cooperation programme prior to its submission to the Commission. This agreement shall also include a commitment of all participating Member States and, where applicable, third countries or territories, to provide the co-financing necessary to implement the cooperation programme and, where applicable, the commitment for the financial contribution of the third countries or territories. By way of derogation from the first subparagraph, in the case of cooperation programmes involving outermost regions and third countries or territories, the Member States concerned shall consult the respective third countries or territories before submitting the cooperation programmes to the Commission. In that case, the agreements to the contents of the cooperation programmes and the possible contribution of the third countries or territories may instead be expressed in the formally approved minutes of the consultation meetings with the third countries or territories or of the deliberations of the regional cooperation organisations. 10. The participating Member States and, where they have accepted the invitation to participate in the cooperation programme, third countries or territories shall draft the cooperation programmes in accordance with the model adopted by the Commission. 11. The Commission shall adopt the model referred to in paragraph 10 by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 150(2) of Regulation (EU) No 1303/2013. 12. The Commission shall adopt a decision, by means of implementing acts, approving all elements, including future amendments, falling under this Article except those falling under point (b)(vii) of paragraph 2, point (c)(v) of paragraph 2, point (e) of paragraph 2, points (a)(i) and (c) of paragraph 4, and paragraphs 5 and 7 of this Article, which remain under the responsibility of the participating Member States. 13. The managing authority shall notify the Commission of any decision amending the elements of the cooperation programme not covered by the Commission decision referred to in paragraph 12, within one month of the date of that amending decision. The amending decision shall specify the date of its entry into force, which shall not be earlier than the date of its adoption. Article 9 Joint Action Plan Where a joint action plan referred to in Article 104(1) of Regulation (EU) No 1303/2013 is carried out under the responsibility of an EGTC as beneficiary, staff of the joint secretariat of the cooperation programme and members of the assembly of the EGTC may become members of the steering committee referred to in Article 108(1) of Regulation (EU) No 1303/2013. The members of the assembly of the EGTC shall not form the majority within that steering committee. Article 10 Community-led local development Community-led local development under Article 32 of Regulation (EU) No 1303/2013 may be implemented in cross-border cooperation programmes, provided that the local development group is composed of representatives of at least two countries, of which one is a Member State. Article 11 Integrated territorial investment For cooperation programmes, the intermediate body for carrying out the management and implementation of an integrated teritorial investment as referred to in Article 36(3) of Regulation (EU) No 1303/2013 shall be either a legal body established under the laws of one of the participating countries provided that it is set up by public authorities or bodies from at least two participating countries, or an EGTC. Article 12 Selection of operations 1. Operations under cooperation programmes shall be selected by a monitoring committee as referred to in Article 47 of Regulation (EU) No 1303/2013. That monitoring committee may set up a steering committee that acts under its responsibility for the selection of operations. 2. Operations selected under cross-border and transnational cooperation shall involve beneficiaries from at least two participating countries, at least one of which shall be from a Member State. An operation may be implemented in a single country, provided that cross-border or transnational impacts and benefits are identified. Operations under interregional cooperation referred to in point (3)(a) and (b) of Article 2 shall involve beneficiaries from at least three countries, at least two of which shall be Member States. The conditions set out in the first subparagraph shall not apply to operations under the PEACE cross-border programme, between Northern Ireland and the border counties of Ireland, in support of peace and reconciliation as referred to in Article 7(2). 3. Notwithstanding paragraph 2, an EGTC or other legal body established under the laws of one of the participating countries may be the sole beneficiary of an operation provided that it is set up by public authorities or bodies from at least two participating countries, in the case of cross-border and transnational cooperation, and from at least three participating countries, in the case of interregional cooperation. A legal body that implements a financial instrument or a fund of funds, as applicable, may be the sole beneficiary of an operation without the application of the requirements for its composition set out in the first subparagraph. 4. Beneficiaries shall cooperate in the development and implementation of operations. In addition, they shall cooperate in the staffing or the financing of operations, or in both. For operations in programmes set up between outermost regions and third countries or territories, the beneficiaries shall be required to cooperate only in two of the fields mentioned in the first subparagraph. 5. For each operation, the managing authority shall provide to the lead or sole beneficiary a document setting out the conditions for support of the operation, including the specific requirements concerning the products or services to be delivered under the operation, the financing plan, and the time-limit for execution. Article 13 Beneficiaries 1. Where there are two or more beneficiaries of an operation in a cooperation programme, one of them shall be designated by all the beneficiaries as the lead beneficiary. 2. The lead beneficiary shall: (a) lay down the arrangements with other beneficiaries in an agreement comprising provisions that, inter alia, guarantee the sound financial management of the funds allocated to the operation, including the arrangements for recovering amounts unduly paid; (b) assume responsibility for ensuring implementation of the entire operation; (c) ensure that expenditure presented by all beneficiaries has been incurred in implementing the operation and corresponds to the activities agreed between all the beneficiaries, and is in accordance with the document provided by the managing authority pursuant to Article 12(5); (d) ensure that the expenditure presented by other beneficiaries has been verified by a controller or controllers where this verification is not carried out by the managing authority pursuant to Article 23(3). 3. If not otherwise specified in the arrangements laid down in accordance with point (a) of paragraph 2 the lead beneficiary shall ensure that the other beneficiaries receive the total amount of the contribution from the funds as quickly as possible and in full. No amount shall be deducted or withheld and no specific charge or other charge with equivalent effect shall be levied that would reduce that amount for the other beneficiaries. 4. Lead beneficiaries shall be located in a Member State participating in the cooperation programme. However, Member States and third countries or territories participating in a cooperation programme may agree to the lead beneficiary being located in a third country or territory participating in that cooperation programme, provided that the managing authority is satisfied that the lead beneficiary can carry out the tasks set out in paragraphs 2 and 3 and that the requirements for management, verification and audit are fulfilled. 5. Sole beneficiaries shall be registered in a Member State participating in the cooperation programme. However, they may be registered in a Member State not participating in the programme, provided the conditions set out in Article 12(3) are satisfied. CHAPTER IV Monitoring and evaluation Article 14 Implementation reports 1. By 31 May 2016 and by the same date of each subsequent year until and including 2023, the managing authority shall submit to the Commission an annual implementation report in accordance with Article 50(1) of Regulation (EU) No 1303/2013. The implementation report submitted in 2016 shall cover the financial years 2014 and 2015, as well as the period between the starting date for eligibility of expenditure and 31 December 2013. 2. For the reports submitted in 2017 and 2019, the deadline referred to in paragraph 1 shall be 30 June. 3. Annual implementation reports shall set out information on: (a) implementation of the cooperation programme in accordance with Article 50(2) of Regulation (EU) No 1303/2013; (b) where appropriate, progress in preparation and implementation of major projects and joint action plans. 4. The annual implementation reports submitted in 2017 and 2019 shall set out and assess the information required under Articles 50(4) and (5) of Regulation (EU) No 1303/2013 respectively and the information set out in paragraph 2 of this Article together with the following information: (a) progress in implementation of the evaluation plan and the follow-up given to the findings of evaluations; (b) the results of the information and publicity measures carried out under the communication strategy; (c) the involvement of the partners in the implementation, monitoring and evaluation of the cooperation programme. The annual implementation reports submitted in 2017 and 2019 may, subject to the content and objectives of each cooperation programme, set out information on and assess the following: (a) progress in the implementation of the integrated approach to territorial development, including sustainable urban development, and community-led local development under the cooperation programme; (b) progress in the implementation of actions to reinforce the capacity of authorities and beneficiaries to administer and to use the ERDF; (c) where appropriate, the contribution to macro-regional and sea basin strategies; (d) the specific actions taken to promote equality between men and women and to promote non-discrimination, in particular accessibility for persons with disabilities, and the arrangements implemented to ensure the integration of gender perspective in the cooperation programme and operations; (e) actions taken to promote sustainable development; (f) progress in the implementation of actions in the field of social innovation. 5. The annual and final implementation reports shall be drawn up following models adopted by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 150(2) of Regulation (EU) No 1303/2013. Article 15 Annual review The annual review meeting shall be organised in accordance with Article 51 of Regulation (EU) No 1303/2013. Where an annual review meeting is not organised pursuant to Article 51(3) of Regulation (EU) No 1303/2013, the annual review may be carried out in writing. Article 16 Indicators for the European territorial cooperation goal 1. Common output indicators, as set out in the Annex to this Regulation, programme-specific result indicators and, where relevant, programme-specific output indicators shall be used in accordance with Article 27(4) of Regulation (EU) No 1303/2013 and with point (b)(ii) and (iv) and point (c)(ii) and (iv) of the first subparagraph of Article 8(2) of this Regulation. 2. For common and programme-specific output indicators, baselines shall be set at zero. Cumulative quantified target values for those indicators shall be set for 2023. 3. For programme-specific result indicators, which relate to investment priorities, baselines shall use the latest available data and targets shall be set for 2023. Targets may be expressed in quantitative or qualitative terms. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 29 to amend the list of common output indicators set out in the Annex, in order to make adjustments, where justified to ensure effective assessment of progress in programme implementation. Article 17 Technical assistance The amount of the ERDF allocated to technical assistance shall be limited to 6 % of the total amount allocated to a cooperation programme. For programmes with a total allocation not exceeding EUR 50 000 000 the amount of the ERDF allocated to technical assistance shall be limited to 7 % of the total amount allocated, but shall not be less than EUR 1 500 000 and not higher than EUR 3 000 000. CHAPTER V Eligibility Article 18 Rules on eligibility of expenditure 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 29 to lay down specific rules on eligibility of expenditure for cooperation programmes with regard to staff costs, office and administrative expenditure, travel and accommodation costs, external expertise and services costs, and equipment expenditure. The Commission shall notify the delegated acts, adopted in accordance with Article 29, simultaneously to the European Parliament and to the Council by 22 April 2014 2. Without prejudice to the eligibility rules laid down in, or on the basis of, Articles 65 to 71 of Regulation (EU) No 1303/2013, Regulation (EU) No 1301/2013, this Regulation or the delegated act referred to in paragraph 1 of this Article, the participating Member States in the monitoring committee, shall establish additional rules on eligibility of expenditure for the cooperation programme as a whole. 3. For matters not covered by eligibility rules laid down in, or on the basis of, Articles 65 to 71 of Regulation (EU) No 1303/2013, Regulation (EU) No 1301/2013, in the delegated act referred to in paragraph 1 of this Article or in rules established jointly by the participating Member States in accordance with paragraph 2 of this Article, the national rules of the Member State in which the expenditure is incurred shall apply. Article 19 Staff costs Staff costs of an operation may be calculated at a flat rate of up to 20 % of the direct costs other than the staff costs of that operation. Article 20 Eligibility of operations in cooperation programmes depending on location 1. Operations under cooperation programmes, subject to the derogations referred to in paragraphs 2 and 3, shall be located in the part of the programme area comprising Union territory (the 'Union part of the programme area'). 2. The managing authority may accept that all or part of an operation is implemented outside the Union part of the programme area, provided that all the following conditions are satisfied: (a) the operation is for the benefit of the programme area; (b) the total amount allocated under the cooperation programme to operations located outside the Union part of the programme area does not exceed 20 % of the support from the ERDF at programme level, or 30 % in the case of cooperation programmes for which the Union part of the programme area consists of outermost regions; (c) the obligations of the managing and audit authorities in relation to management, control and audit concerning the operation are fulfilled by the cooperation programme authorities, or they enter into agreements with authorities in the Member State or third country or territory in which the operation is implemented. 3. For operations concerning technical assistance or promotional activities and capacity-building, expenditure may be incurred outside the Union part of the programme area provided that the conditions in points (a) and (c) of paragraph 2 are satisfied. CHAPTER VI Management, control and designation Article 21 Designation of authorities 1. Member States participating in a cooperation programme shall designate, for the purposes of Article 123(1) of Regulation (EU) No 1303/2013, a single managing authority; for the purposes of Article 123(2) of that Regulation, a single certifying authority; and, for the purposes of Article 123(4) of that Regulation, a single audit authority. The managing authority and the audit authority shall be located in the same Member State. Member States participating in a cooperation programme may designate the managing authority as also being responsible for carrying out the functions of the certifying authority. Such a designation shall be without prejudice to the apportionment of liabilities in relation to the application of financial corrections among the participating Member States as laid down in the cooperation programme. 2. The certifying authority shall receive the payments made by the Commission and shall, as a general rule, make payments to the lead beneficiary in accordance with Article 132 of Regulation (EU) No 1303/2013. 3. The procedure for the designation of the managing authority and, where appropriate, of the certifying authority, set out in Article 124 of Regulation (EU) No 1303/2013, shall be carried out by the Member State in which the authority is located. Article 22 European grouping of territorial cooperation Member States participating in a cooperation programme may make use of an EGTC for the purposes of making it responsible for managing that cooperation programme or part thereof, in particular by conferring on it the responsibilities of a managing authority. Article 23 Functions of the managing authority 1. Without prejudice to paragraph 4 of this Article, the managing authority of a cooperation programme shall carry out the functions laid down in Article 125 of Regulation (EU) No 1303/2013. 2. The managing authority, after consultation with the Member States and any third countries participating in a cooperation programme, shall set up a joint secretariat. The joint secretariat shall assist the managing authority and the monitoring committee in carrying out their respective functions. The joint secretariat shall also provide information to potential beneficiaries about funding opportunities under cooperation programmes and shall assist beneficiaries in the implementation of operations. 3. Where the managing authority is an EGTC, verifications under point (a) of Article 125(4) of Regulation (EU) No 1303/2013 shall be carried out by or under the responsibility of the managing authority at least for those Member States and third countries or territories from which there are members participating in the EGTC. 4. Where the managing authority does not carry out verifications under point (a) of Article 125(4) of Regulation (EU) No 1303/2013 throughout the whole programme area, or where the verifications are not carried out by or under the responsibility of the managing authority for those Member States and third countries or territories from which there are members participating in the EGTC in accordance with paragraph 3, each Member State or, where it has accepted the invitation to participate in the cooperation programme, each third country or territory shall designate the body or person responsible for carrying out such verifications in relation to beneficiaries on its territory (the 'controller(s)'). The controllers referred to in the first subparagraph may be the same bodies responsible for carrying out such verifications for the operational programmes under the Investment for growth and jobs goal or, in the case of third countries, for carrying out comparable verifications under external policy instruments of the Union. The managing authority shall satisfy itself that the expenditure of each beneficiary participating in an operation has been verified by a designated controller. Each Member State shall ensure that the expenditure of a beneficiary can be verified within a period of three months of the submission of the documents by the beneficiary concerned. Each Member State or, where it has accepted the invitation to participate in the cooperation programme, each third country shall be responsible for verifications carried out on its territory. 5. Where the delivery of co-financed products or services can be verified only in respect of an entire operation, the verification shall be performed by the managing authority or by the controller of the Member State where the lead beneficiary is located. Article 24 Functions of the certifying authority The certifying authority of a cooperation programme shall carry out the functions laid down in Article 126 of Regulation (EU) No 1303/2013. Article 25 Functions of the audit authority 1. The Member States and third countries participating in a cooperation programme may authorise the audit authority to carry out directly the functions provided for in Article 127 of Regulation (EU) No 1303/2013 in the whole of the territory covered by a cooperation programme. They shall specify when the audit authority is to be accompanied by an auditor of a Member State or a third country. 2. Where the audit authority does not have the authorisation referred to in paragraph 1, it shall be assisted by a group of auditors composed of a representative from each Member State or third country participating in the cooperation programme and carrying out the functions provided for in Article 127 of Regulation (EU) No 1303/2013. Each Member State or, where it has accepted the invitation to participate in a cooperation programme, each third country shall be responsible for audits carried out on its territory. Each representative from each Member State or third country participating in the cooperation programme shall be responsible for providing the factual elements relating to expenditure on its territory that are required by the audit authority in order to perform its assessment. The group of auditors shall be set up within three months of the decision approving the cooperation programme. It shall draw up its own rules of procedure and be chaired by the audit authority for the cooperation programme. 3. The auditors shall be functionally independent of controllers who carry out verifications under Article 23. CHAPTER VII Participation of third countries in transnational and interregional cooperation programmes Article 26 Implementation conditions for the participation of third countries The applicable programme implementation conditions governing the financial management as well as the programming, monitoring, evaluation and control of the participation of third countries, through a contribution of IPA II or ENI resources to transnational and interregional cooperation programmes, shall be established in the relevant cooperation programme and also, where necessary, in the financing agreement between the Commission, the governments of the third countries concerned and the Member State hosting the managing authority of the relevant cooperation programme. Programme implementation conditions shall be consistent with the Union's cohesion policy rules. CHAPTER VIII Financial management Article 27 Budget commitments, payments and recoveries 1. The ERDF support to cooperation programmes shall be paid into a single account with no national subaccounts. 2. The managing authority shall ensure that any amount paid as a result of an irregularity is recovered from the lead or sole beneficiary. Beneficiaries shall repay to the lead beneficiary any amounts unduly paid. 3. If the lead beneficiary does not succeed in securing repayment from other beneficiaries or if the managing authority does not succeed in securing repayment from the lead or sole beneficiary, the Member State or third country on whose territory the beneficiary concerned is located or, in the case of an EGTC, is registered shall reimburse the managing authority any amounts unduly paid to that beneficiary. The managing authority shall be responsible for reimbursing the amounts concerned to the general budget of the Union, in accordance with the apportionment of liabilities among the participating Member States as laid down in the cooperation programme. Article 28 Use of the euro By way of derogation from Article 133 of Regulation (EU) No 1303/2013, expenditure incurred in a currency other than the euro shall be converted into euro by the beneficiaries using the monthly accounting exchange rate of the Commission in the month during which that expenditure was either: (a) incurred; (b) submitted for verification to the managing authority or the controller in accordance with Article 23 of this Regulation; or (c) reported to the lead beneficiary. The method chosen shall be set out in the cooperation programme and be applicable to all beneficiaries. The conversion shall be verified by the managing authority or by the controller in the Member State or third country in which the beneficiary is located. CHAPTER IX Final provisions Article 29 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power to adopt delegated acts referred to in Articles 16(4) and 18(1) shall be conferred on the Commission from 21 December 2013 until 31 December 2020. 3. The delegation of power referred to in Articles 16(4) and 18(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 16(4) and 18(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 30 Transitional provisions 1. This Regulation shall not affect either the continuation or modification, including the total or partial cancellation of assistance approved by the Commission on the basis of Regulation (EC) No 1080/2006 or any other legislation applying to that assistance on 31 December 2013. That Regulation or such other applicable legislation shall consequently continue to apply after 31 December 2013 to that assistance or the operations concerned until their closure. For the purposes of this paragraph assistance shall cover operational programmes and major projects. 2. Applications to receive assistance made or approved under Regulation (EC) No 1080/2006 before 1 January 2014 shall remain valid. Article 31 Review The European Parliament and the Council shall review this Regulation by 31 December 2020, in accordance with Article 178 TFEU. Article 32 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. Articles 4, 27 and 28 shall apply with effect from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 December 2013. For the European Parliament The President M. SCHULZ For the Council The President R. \u0160AD\u017dIUS (1) OJ C 191, 29.6.2012, p. 49. (2) OJ C 277, 13.9.2012, p. 96. (3) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (See page 320 of this Official Journal). (4) Regulation (EU) No 1301/2013 of the European Parliament and of the Council of 17 December 2013 on the European Regional Development Fund and on specific provisions concerning the Investment for growth and jobs goal and repealing Regulation (EC) No 1080/2006 (See page 289 of this Official Journal). (5) Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1). (6) Regulation (EU) No 1302/2013 of the European Parliament and of the Council of 17 December 2013 amending Regulation (EC) No 1082/2006 on a European grouping of territorial cooperation (EGTC) as regards the clarification, simplification and improvement of the establishment and functioning of such groupings (See page 303 of this Official Journal). (7) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control, by Member States, of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (8) Regulation (EC) No 1080/2006 of the European Parliament and of the Council of 5 July 2006 on the European Regional Development Fund and repealing Regulation (EC) No 1783/1999 (OJ L 210, 31.7.2006, p. 1). (9) Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010 (OJ L 348, 20.12.2013, p. 129). ANNEX COMMON OUTPUT INDICATORS FOR THE EUROPEAN TERRITORIAL COOPERATION GOAL UNIT NAME Productive investment enterprises Number of enterprises receiving support enterprises Number of enterprises receiving grants enterprises Number of enterprises receiving financial support other than grants enterprises Number of enterprises receiving non-financial support enterprises Number of new enterprises supported enterprises Number of enterprises participating in cross-border, transnational or interregional research projects organisations Number of research institutions participating in cross-border, transnational or interregional research projects EUR Private investment matching public support to enterprises (grants) EUR Private investment matching public support to enterprises (non-grants) full time equivalents Employment increase in supported enterprises Sustainable tourism visits/year Increase in expected number of visits to supported sites of cultural and natural heritage and attractions ICT Infrastructure households Additional households with broadband access of at least 30 Mbps Transport Railway kilometres Total length of new railway lines of which: TEN-T kilometres Total length of reconstructed or upgraded railway lines of which: TEN-T Roads kilometres Total length of newly built roads of which: TEN-T kilometres Total length of reconstructed or upgraded roads of which: TEN-T Urban transport kilometres Total length of new or improved tram and metro lines Inland waterways kilometres Total length of new or improved inland waterways Environment Solid waste tonnes/year Additional waste recycling capacity Water supply persons Additional population served by improved water supply Wastewater treatment population equivalent Additional population served by improved wastewater treatment Risk prevention and management persons Population benefiting from flood protection measures persons Population benefiting from forest fire protection measures Land rehabilitation hectares Total surface area of rehabilitated land Nature and biodiversity hectares Surface area of habitats supported in order to attain a better conservation status Research, Innovation full time equivalents Number of new researchers in supported entities full time equivalents Number of researchers working in improved research infrastructure facilities enterprises Number of enterprises cooperating with research institutions EUR Private investment matching public support in innovation or R&D projects enterprises Number of enterprises supported to introduce new to the market products enterprises Number of enterprises supported to introduce new to the firm products Energy and Climate change Renewables MW Additional capacity of renewable energy production Energy efficiency households Number of households with improved energy consumption classification kWh/year Decrease of annual primary energy consumption of public buildings users Number of additional energy users connected to smart grids GHG reduction tonnes of CO2eq Estimated annual decrease of GHG Social infrastructure Childcare & education persons Capacity of supported childcare or education infrastructure Health persons Population covered by improved health services Urban development specific indicators persons Population living in areas with integrated urban development strategies square metres Open space created or rehabilitated in urban areas square metres Public or commercial buildings built or renovated in urban areas housing units Rehabilitated housing in urban areas Labour Market and Training (1) persons Number of participants in cross-border mobility initiatives persons Number of participants in joint local employment initiatives and joint training persons Number of participants in projects promoting gender equality, equal opportunities and social inclusion across borders persons Number of participants in joint education and training schemes to support youth employment, educational opportunities and higher and vocational education across borders (1) Where relevant, the information on participants will be broken down by their labour market status, indicating whether they are \"employed\", \"unemployed\", \"long-term unemployed\", \"inactive\" or \"inactive and not in education or training\". Joint statement of the European Parliament and of the Council concerning the application of Article 6 of the ERDF Regulation, Article 15 of the ETC Regulation and Article 4 of the Cohesion Fund Regulation The European Parliament and the Council note the assurance provided by the Commission to the EU legislature that the common output indicators for the ERDF Regulation, the ETC Regulation and the Cohesion Fund Regulation to be included in an annex to, respectively, each regulation, are the outcome of a lengthy preparatory process involving the evaluation experts of both the Commission and the Member States and, in principle, are expected to remain stable.", "summary": "Strengthening European territorial cooperation Strengthening European territorial cooperation SUMMARY OF: Regulation (EU) No 1299/2013 - support from the European Regional Development Fund for European territorial cooperation SUMMARY WHAT DOES THE REGULATION DO? It sets out the objectives, criteria and funds available under the European Regional Development Fund (ERDF) for 2014-20 with specific reference to European territorial cooperation (ETC) - one of the goals of EU regional policy. KEY POINTS Overall aims European territorial cooperation (ETC) is a core objective of EU regional policy and is financed by the European Regional Development Fund (ERDF). The regulation describes the background and general principles of ETC and specifies the scope of the ERDF in achieving the objectives of territorial cooperation for the period 2014-20. The aim of ETC is to encourage regions and cities from different EU countries to work together and learn from each other through joint programmes, projects and networks. ETC programmes come in 3 types: \u2014 cross-border cooperation: financing joint projects implemented directly at EU borders, for example between neighbouring land or maritime border-regions, or a region in at least one EU country and non-EU country on the external borders of the EU. These regions in non-EU countries must not be covered by programmes under the EU's external financial instruments; \u2014 transnational cooperation programmes: involve national, regional and local partners over larger areas of cooperation, such as the Baltic Sea Region; \u2014 interregional cooperation: all EU countries are eligible to participate in projects of this type. It includes projects and networks for the exchange of experience and good practice between regional and local bodies in different countries. These projects aim to ensure that cohesion policy resources are applied effectively. Management of programmes As ETC programmes consist of a group of EU countries and sometimes non-EU countries, they are managed by a body jointly designated by the participating countries. Reporting Regulation (EU) 2015/207 lays down the detailed rules that managing authorities need to follow for drawing up the annual and final implementation reports. Budget The budget within the ERDF for ETC is \u20ac8.9 billion over the 2014-20 period. The contribution to the 3 main types of programme is broken down as follows: \u2014 cross-border cooperation: \u20ac6.6 billion; \u2014 transnational cooperation: \u20ac1.8 billion; \u2014 interregional cooperation: \u20ac500 million. List of cooperation programmes Commission Implementing Decision 2014/366/EU sets out the list of cooperation programmes and the amount of ERDF support for each programme. BACKGROUND The ERDF is 1 of 5 European Structural and Investment Funds that work together to support economic, social and territorial cohesion and deliver the objectives of the EU's Europe 2020 strategy to generate smart, sustainable and inclusive growth. ACT Regulation (EU) No 1299/2013 of the European Parliament and of the Council of 17 December 2013 on specific provisions for the support from the European Regional Development Fund to the European territorial cooperation goal REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 1299/2013 21.12.2013 - OJ L 347, 20.12.2013, pp 259-280 RELATED ACTS Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions and general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (OJ L 347, 20.12.2013, pp. 320-469) Regulation (EU) No 1301/2013 of the European Parliament and of the Council of 17 December 2013 on the European Regional Development Fund and on specific provisions concerning the investment for growth and jobs goal and repealing Regulation (EC) No 1080/2006 (OJ L 347, 20.12.2013, pp. 289-302) Regulation (EC) No 1082/2006 of the European Parliament and of the Council of 5 July 2006 on a European grouping of territorial cooperation (EGTC) (OJ L 210, 31.7.2006, pp. 19-24). See consolidated version. Commission Delegated Regulation (EU) No 480/2014 of 3 March 2014 supplementing Regulation (EU) No 1303/2013 of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund (OJ L 138, 13.5.2014, pp. 5-44). See consolidated version. Commission Delegated Regulation (EU) No 481/2014 of 4 March 2014 supplementing Regulation (EU) No 1299/2013 of the European Parliament and of the Council with regard to specific rules on eligibility of expenditure for cooperation programmes (OJ L 138, 13.5.2014, pp. 45-50) Commission Implementing Regulation (EU) No 288/2014 of 25 February 2014 laying down rules pursuant to Regulation (EU) No 1303/2013 of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund with regard to the model for operational programmes under the investment for growth and jobs goal and pursuant to Regulation (EU) No 1299/2013 of the European Parliament and of the Council on specific provisions for the support from the European Regional Development Fund to the European territorial cooperation goal with regard to the model for cooperation programmes under the European territorial cooperation goal (OJ L 87, 22.3.2014, pp. 1-48) Commission Implementing Decision 2014/366/EU of 16 June 2014 setting up the list of cooperation programmes and indicating the global amount of total support from the European Regional Development Fund for each programme under the European territorial cooperation goal for the period 2014 to 2020 (OJ L 178, 18.6.2014, pp 18-25). See consolidated version. Commission Implementing Decision 2014/388/EU of 16 June 2014 setting up the list of regions and areas eligible for funding from the European Regional Development Fund under the cross-border and transnational components of the European territorial cooperation goal for the period 2014 to 2020 (OJ L 183, 24.6.2014, pp. 75-134) Commission Implementing Regulation (EU) No 184/2014 of 25 February 2014 laying down pursuant to Regulation (EU) No 1303/2013 of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund, the terms and conditions applicable to the electronic data exchange system between the Member States and the Commission and adopting pursuant to Regulation (EU) No 1299/2013 of the European Parliament and of the Council on specific provisions for the support from the European Regional Development Fund to the European territorial cooperation goal, the nomenclature of the categories of intervention for support from the European Regional Development Fund under the European territorial cooperation goal (OJ L 57, 27.2.2014, pp. 7-20). Commission Implementing Regulation (EU) No 821/2014 of 28 July 2014 laying down rules for the application of Regulation (EU) No 1303/2013 of the European Parliament and of the Council as regards detailed arrangements for the transfer and management of programme contributions, the reporting on financial instruments, technical characteristics of information and communication measures for operations and the system to record and store data (OJ L 223, 29.7.2014, pp. 7-18) Commission Implementing Regulation (EU) 2015/207 of 20 January 2015 laying down detailed rules implementing Regulation (EU) No 1303/2013 of the European Parliament and of the Council as regards the models for the progress report, submission of the information on a major project, the joint action plan, the implementation reports for the Investment for growth and jobs goal, the management declaration, the audit strategy, the audit opinion and the annual control report and the methodology for carrying out the cost-benefit analysis and pursuant to Regulation (EU) No 1299/2013 of the European Parliament and of the Council as regards the model for the implementation reports for the European territorial cooperation goal (OJ L 38, 13.2.2015, pp. 1-122) last update 12.10.2015"}
{"article": "25.4.2013 EN Official Journal of the European Union L 115/39 REGULATION (EU) No 347/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 172 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) On 26 March 2010, the European Council agreed to the Commission\u2019s proposal to launch a new strategy \u2018Europe 2020\u2019. One of the priorities of the Europe 2020 strategy is sustainable growth to be achieved by promoting a more resource-efficient, more sustainable and more competitive economy. That strategy put energy infrastructures at the forefront as part of the flagship initiative \u2018Resource efficient Europe\u2019, by underlining the need to urgently upgrade Europe\u2019s networks, interconnecting them at the continental level, in particular to integrate renewable energy sources. (2) The target agreed in the conclusions of the March 2002 Barcelona European Council for Member States to have a level of electricity interconnections equivalent to at least to 10 % of their installed production capacity has not yet been achieved. (3) The communication from the Commission entitled \u2018Energy infrastructure priorities for 2020 and beyond \u2014 A Blueprint for an integrated European energy network\u2019, followed by the Council conclusions of 28 February 2011 and the European Parliament resolution (4), called for a new energy infrastructure policy to optimise network development at European level for the period up to 2020 and beyond, in order to allow the Union to meet its core energy policy objectives of competitiveness, sustainability and security of supply. (4) The European Council of 4 February 2011 underlined the need to modernise and expand Europe\u2019s energy infrastructure and to interconnect networks across borders, in order to make solidarity between Member States operational, to provide for alternative supply or transit routes and sources of energy and to develop renewable energy sources in competition with traditional sources. It insisted that no Member State should remain isolated from the European gas and electricity networks after 2015 or see its energy security jeopardised by lack of the appropriate connections. (5) Decision No 1364/2006/EC of the European Parliament and of the Council (5) lays down guidelines for trans-European energy networks (TEN-E). Those guidelines have as objectives to support the completion of the Union internal energy market while encouraging the rational production, transportation, distribution and use of energy resources, to reduce the isolation of less-favoured and island regions, to secure and diversify the Union\u2019s energy supplies, sources and routes, including through cooperation with third countries, and to contribute to sustainable development and protection of the environment. (6) Evaluation of the current TEN-E framework has clearly shown that this framework, while making a positive contribution to selected projects by giving them political visibility, lacks vision, focus, and flexibility to fill identified infrastructure gaps. The Union should therefore increase its efforts to meet future challenges in this field, and due attention should be paid to identifying potential future gaps in energy demand and supply. (7) Accelerating the refurbishment of existing energy infrastructure and the deployment of new energy infrastructure is vital to achieve the Union\u2019s energy and climate policy objectives, consisting of completing the internal market in energy, guaranteeing security of supply, in particular for gas and oil, reducing greenhouse gas emissions by 20 % (30 % if the conditions are right), increasing the share of renewable energy in final energy consumption to 20 % (6) and achieving a 20 % increase in energy efficiency by 2020 whereby energy efficiency gains may contribute to reducing the need for construction of new infrastructures. At the same time, the Union has to prepare its infrastructure for further decarbonisation of its energy system in the longer term towards 2050. This Regulation should therefore also be able to accommodate possible future Union energy and climate policy objectives. (8) Despite the fact that Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity (7) and Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas (8) provide for an internal market in energy, the market remains fragmented due to insufficient interconnections between national energy networks and to the suboptimal utilisation of existing energy infrastructure. However, Union-wide integrated networks and deployment of smart grids are vital for ensuring a competitive and properly functioning integrated market, for achieving an optimal utilisation of energy infrastructure, for increased energy efficiency and integration of distributed renewable energy sources and for promoting growth, employment and sustainable development. (9) The Union\u2019s energy infrastructure should be upgraded in order to prevent technical failure and to increase its resilience against such failure, natural or man-made disasters, adverse effects of climate change and threats to its security, in particular as regards European critical infrastructures as set out in Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection (9). (10) Transporting oil through land pipelines rather than over water can make an important contribution to lowering the environmental risk associated with the transportation of oil. (11) The importance of smart grids in achieving the Union\u2019s energy policy objectives has been acknowledged in the communication from the Commission of 12 April 2011 entitled \u2018Smart grids: from innovation to deployment\u2019. (12) Energy storage facilities and reception, storage and regasification or decompression facilities for liquefied natural gas (LNG) and compressed natural gas (CNG) have an increasingly important role to play in the European energy infrastructure. The expansion of such energy infrastructure facilities forms an important component of a well-functioning network infrastructure. (13) The communication from the Commission of 7 September 2011 entitled \u2018The EU Energy Policy: Engaging with Partners beyond Our Borders\u2019 underlined the need for the Union to include the promotion of energy infrastructure development in its external relations with a view to supporting socio-economic development beyond the Union borders. The Union should facilitate infrastructure projects linking the Union\u2019s energy networks with third-country networks, in particular with neighbouring countries and with countries with which the Union has established specific energy cooperation. (14) To ensure voltage and frequency stability, particular attention should be focused on the stability of the European electricity network under the changing conditions caused by the growing inflow of energy from renewable resources that are variable in nature. (15) The investment needs up to 2020 in electricity and gas transmission infrastructures of European relevance have been estimated at about EUR 200 billion. The significant increase in investment volumes compared to past trends and the urgency of implementing the energy infrastructure priorities requires a new approach in the way energy infrastructures, and in particular those of a cross-border nature, are regulated and financed. (16) The Commission Staff Working Paper for the Council of 10 June 2011 entitled \u2018Energy infrastructure investment needs and financing requirements\u2019 stressed that approximately half of the total investments needed for the decade up to 2020 are at risk of not being delivered at all or not in time due to obstacles related to the granting of permits, regulatory issues and financing. (17) This Regulation lays down rules for the timely development and interoperability of trans-European energy networks in order to achieve the energy policy objectives of the Treaty on the Functioning of the European Union (TFEU) to ensure the functioning of the internal energy market and security of supply in the Union, to promote energy efficiency and energy saving and the development of new and renewable forms of energy, and to promote the interconnection of energy networks. By pursuing these objectives, this Regulation contributes to smart, sustainable and inclusive growth and brings benefits to the entire Union in terms of competitiveness and economic, social and territorial cohesion. (18) It is essential for the development of trans-European networks and their effective interoperability to ensure operational coordination between electricity transmission system operators (TSOs). In order to ensure uniform conditions for the implementation of the relevant provisions of Regulation (EC) No 714/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the network for cross-border exchanges in electricity (10) in this respect, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (11). The examination procedure should be used for the adoption of the guidelines on the implementation of operational coordination between electricity TSOs at Union level, given that those guidelines will apply generally to all TSOs. (19) The Agency for the Cooperation of Energy Regulators (the \u2018Agency\u2019) established by Regulation (EC) No 713/2009 of the European Parliament and of the Council (12) is allocated important additional tasks under this Regulation and should be given the right to levy fees for some of these additional tasks. (20) Following close consultations with all Member States and stakeholders, the Commission has identified 12 strategic trans-European energy infrastructure priorities, the implementation of which by 2020 is essential for the achievement of the Union\u2019s energy and climate policy objectives. These priorities cover different geographic regions or thematic areas in the field of electricity transmission and storage, gas transmission, storage and liquefied or compressed natural gas infrastructure, smart grids, electricity highways, carbon dioxide transport and oil infrastructure. (21) Projects of common interest should comply with common, transparent and objective criteria in view of their contribution to the energy policy objectives. For electricity and gas, in order to be eligible for inclusion in the second and subsequent Union lists, projects should be part of the latest available 10-year network development plan. This plan should notably take account of the conclusions of the European Council of 4 February 2011 with regard to the need to integrate peripheral energy markets. (22) Regional groups should be established for the purpose of proposing and reviewing projects of common interest, leading to the establishment of regional lists of projects of common interest. In order to ensure broad consensus, these regional groups should ensure close cooperation between Member States, national regulatory authorities, project promoters and relevant stakeholders. The cooperation should rely as much as possible on existing regional cooperation structures of national regulatory authorities and TSOs and other structures established by the Member States and the Commission. In the context of this cooperation, national regulatory authorities should, when necessary, advise the regional groups, inter alia on the feasibility of the regulatory aspects of proposed projects and on the feasibility of the proposed timetable for regulatory approval. (23) In order to ensure that the Union list of projects of common interest (\u2018Union list\u2019) is limited to projects which contribute the most to the implementation of the strategic energy infrastructure priority corridors and areas, the power to adopt and review the Union list should be delegated to the Commission in accordance with Article 290 of the TFEU, while respecting the right of the Member States to approve projects of common interest related to their territory. According to analysis carried out in the impact assessment accompanying the proposal that has led to this Regulation, the number of such projects is estimated at some 100 in the field of electricity and 50 in the field of gas. Taking into account this estimate, and the need to ensure the achievement of the objectives of this Regulation, the total number of projects of common interest should remain manageable, and therefore should not significantly exceed 220. The Commission, when preparing and drawing up delegated acts, should ensure the simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (24) A new Union list should be established every two years. Projects of common interest that are completed or that no longer fulfil the relevant criteria and requirements as set out in this Regulation should not appear on the next Union list. For that reason, existing projects of common interest that are to be included in the next Union list should be subject to the same selection process for the establishment of regional lists and for the establishment of the Union list as proposed projects; however, care should be taken to minimise the resulting administrative burden as much as possible, for example by using to the extent possible information submitted previously, and by taking account of the annual reports of the project promoters. (25) Projects of common interest should be implemented as quickly as possible and should be closely monitored and evaluated, while keeping the administrative burden for project promoters to a minimum. The Commission should nominate European coordinators for projects facing particular difficulties. (26) Permit granting processes should neither lead to administrative burdens which are disproportionate to the size or complexity of a project, nor create barriers to the development of the trans-European networks and market access. The conclusions of the Council of 19 February 2009 highlighted the need to identify and remove barriers to investment, including by means of streamlining of planning and consultation procedures. Those conclusions were reinforced by the conclusions of the European Council of 4 February 2011 which again underlined the importance of streamlining and improving permit granting processes while respecting national competences. (27) The planning and implementation of Union projects of common interest in the areas of energy, transport and telecommunication infrastructure should be coordinated to generate synergies whenever to do so makes sense from an overall economic, technical, environmental or spatial planning point of view and with due regard to the relevant safety aspects. Thus, when the various European networks are being planned, preference could be given to integrating transport, communication and energy networks in order to ensure that as little land as possible is taken up, whilst ensuring, where possible, that existing or disused routes are reused, in order to reduce to a minimum any negative social, economic, environmental and financial impact. (28) Projects of common interest should be given \u2018priority status\u2019 at national level to ensure rapid administrative treatment. Projects of common interest should be considered by competent authorities as being in the public interest. Authorisation should be given to projects which have an adverse impact on the environment, for reasons of overriding public interest, when all the conditions under Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (13) and Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (14) are met. (29) The establishment of a competent authority or authorities integrating or coordinating all permit granting processes (\u2018one-stop shop\u2019) should reduce complexity, increase efficiency and transparency and help enhance cooperation among Member States. Upon their designation, the competent authorities should be operational as soon as possible. (30) Despite the existence of established standards for the participation of the public in environmental decision-making procedures, additional measures are needed to ensure the highest possible standards of transparency and public participation for all relevant issues in the permit granting process for projects of common interest. (31) The correct and coordinated implementation of Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (15), of Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (16), where applicable, of the Convention on access to information, public participation in decision-making and access to justice in environmental matters, signed in Aarhus on 25 June 1998 (17) (the \u2018Aarhus Convention\u2019), and of the Espoo Convention on environmental impact assessment in a transboundary context (the \u2018Espoo Convention\u2019) should ensure the harmonisation of the main principles for the assessment of environmental effects, including in a cross-border context. Member States should coordinate their assessments for projects of common interest, and provide for joint assessments, where possible. Member States should be encouraged to exchange best practice and administrative capacity-building for permit granting processes. (32) It is important to streamline and improve permit granting processes, while respecting \u2014 to the extent possible with due regard to the principle of subsidiarity \u2014 national competences and procedures for the construction of new infrastructure. Given the urgency of developing energy infrastructures, the simplification of permit granting processes should be accompanied by a clear time-limit for the decision to be taken by the respective authorities regarding the construction of the project. That time limit should stimulate a more efficient definition and handling of procedures, and should under no circumstances compromise the high standards for the protection of the environment and public participation. With regard to the maximum time limits established by this Regulation, Member States could nevertheless strive to further shorten them if feasible. The competent authorities should ensure compliance with the time limits, and Member States should endeavour to ensure that appeals challenging the substantive or procedural legality of a comprehensive decision are handled in the most efficient way possible. (33) Where Member States consider it appropriate, they may include in the comprehensive decision decisions taken in the context of: negotiations with individual landowners to granting access to, ownership of, or a right to occupy property; spatial planning which determines the general land use of a defined region, includes other developments such as highways, railways, buildings and nature protection areas, and is not undertaken for the specific purpose of the planned project; granting of operational permits. In the context of the permit granting processes, a project of common interest could include related infrastructure to the extent that it is essential for the construction or functioning of the project. (34) This Regulation, in particular the provisions on permit granting, public participation and the implementation of projects of common interest, should apply without prejudice to international and Union law, including provisions to protect the environment and human health, and provisions adopted under the Common Fisheries and Maritime Policy. (35) The costs for the development, construction, operation and maintenance of projects of common interest should in general be fully borne by the users of the infrastructure. Projects of common interest should be eligible for cross-border cost allocation when an assessment of market demand or of the expected effects on the tariffs have indicated that costs cannot be expected to be recovered by the tariffs paid by the infrastructure users. (36) The basis for the discussion on the appropriate allocation of costs should be the analysis of the costs and benefits of an infrastructure project on the basis of a harmonised methodology for energy-system-wide analysis, in the framework of the 10-year network development plans prepared by the European Networks of Transmission System Operators under Regulation (EC) No 714/2009 and Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks (18), and reviewed by the Agency. That analysis could take into consideration indicators and corresponding reference values for the comparison of unit investment costs. (37) In an increasingly integrated internal energy market, clear and transparent rules for cost allocation across borders are necessary in order to accelerate investment in cross-border infrastructure. The European Council of 4 February 2011 recalled the importance of promoting a regulatory framework attractive to investment in networks, with tariffs set at levels consistent with financing needs and the appropriate cost allocation for cross-border investments, while enhancing competition and competitiveness and taking account of the impact on consumers. When deciding on cross-border cost allocation, national regulatory authorities should ensure that its impact on national tariffs does not represent a disproportionate burden for consumers. The national regulatory authorities should also avoid the risks of double support for projects by taking into account actual or estimated charges and revenues. Those charges and revenues should be taken into account only insofar as they are designed to cover the costs concerned and as much as possible related to the projects. When an investment request takes into account benefits beyond the borders of the Member States concerned, the national regulatory authorities should consult the TSOs concerned on the project-specific cost-benefit analysis. (38) The existing internal energy market law requires that tariffs for access to gas and electricity networks provide appropriate incentives for investment. When applying the internal energy market law, national regulatory authorities should ensure a stable and predictable regulatory framework with incentives for projects of common interest, including long-term incentives, that are commensurate with the level of specific risk of the project. This applies in particular to innovative transmission technologies for electricity allowing for large scale integration of renewable energy, of distributed energy resources or of demand response in interconnected networks, and to gas transmission infrastructure offering advanced capacity or additional flexibility to the market to allow for short-term trading or back-up supply in case of supply disruptions. (39) This Regulation applies only to the granting of permits for, public participation in, and the regulatory treatment of projects of common interest within the meaning set out herein. Member States may nevertheless apply, by virtue of their national law, the same or similar rules to other projects which do not have the status of projects of common interest within the scope of this Regulation. As regards the regulatory incentives, Member States may apply, by virtue of their national law, the same or similar rules to projects of common interest falling under the category of electricity storage. (40) Member States that currently do not provide for a legal status of the highest national significance possible that is attributable to energy infrastructure projects in the context of permit granting processes should consider introducing such a status, in particular by evaluating if this would lead to a quicker permit granting process. (41) The European Energy Programme for Recovery (EEPR), established by Regulation (EC) No 663/2009 of the European Parliament and of the Council (19) has demonstrated the added value of leveraging private funding through significant Union financial assistance to allow the implementation of projects of European significance. The European Council of 4 February 2011 recognised that some energy infrastructure projects may require limited public finance to leverage private funding. In the light of the economic and financial crisis and budgetary constraints, targeted support, through grants and financial instruments, should be developed under the next multiannual financial framework, which will attract new investors into the energy infrastructure priority corridors and areas, while keeping the budgetary contribution of the Union to a minimum. The relevant measures should draw on the experience gained during the pilot phase following the introduction of project bonds to finance infrastructure projects. (42) Projects of common interest in the fields of electricity, gas and carbon dioxide should be eligible to receive Union financial assistance for studies and, under certain conditions, for works as soon as such funding becomes available under the relevant Regulation on a Connecting Europe Facility in the form of grants or in the form of innovative financial instruments. This will ensure that tailor-made support can be provided to those projects of common interest which are not viable under the existing regulatory framework and market conditions. It is important to avoid any distortion of competition, in particular between projects contributing to the achievement of the same Union priority corridor. Such financial assistance should ensure the necessary synergies with the Structural Funds, which will finance smart energy distribution networks of local or regional importance. A three-step logic applies to investments in projects of common interest. First, the market should have the priority to invest. Second, if investments are not made by the market, regulatory solutions should be explored, if necessary the relevant regulatory framework should be adjusted, and the correct application of the relevant regulatory framework should be ensured. Third, where the first two steps are not sufficient to deliver the necessary investments in projects of common interest, Union financial assistance could be granted if the project of common interest fulfils the applicable eligibility criteria. (43) Since the objective of this Regulation, namely the development and interoperability of trans-European energy networks and connection to such networks, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (44) Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 should therefore be amended accordingly. (45) Decision No 1364/2006/EC should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation lays down guidelines for the timely development and interoperability of priority corridors and areas of trans-European energy infrastructure set out in Annex I (\u2018energy infrastructure priority corridors and areas\u2019). 2. In particular, this Regulation: (a) addresses the identification of projects of common interest necessary to implement priority corridors and areas falling under the energy infrastructure categories in electricity, gas, oil, and carbon dioxide set out in Annex II (\u2018energy infrastructure categories\u2019); (b) facilitates the timely implementation of projects of common interest by streamlining, coordinating more closely, and accelerating permit granting processes and by enhancing public participation; (c) provides rules and guidance for the cross-border allocation of costs and risk-related incentives for projects of common interest; (d) determines the conditions for eligibility of projects of common interest for Union financial assistance. Article 2 Definitions For the purpose of this Regulation, in addition to the definitions provided for in Directives 2009/28/EC, 2009/72/EC and 2009/73/EC, Regulations (EC) No 713/2009, (EC) No 714/2009, and (EC) No 715/2009, the following definitions shall apply: (1) \u2018energy infrastructure\u2019 means any physical equipment or facility falling under the energy infrastructure categories which is located within the Union or linking the Union and one or more third countries; (2) \u2018comprehensive decision\u2019 means the decision or set of decisions taken by a Member State authority or authorities not including courts or tribunals, that determines whether or not a project promoter is to be granted authorisation to build the energy infrastructure to realise a project without prejudice to any decision taken in the context of an administrative appeal procedure; (3) \u2018project\u2019 means one or several lines, pipelines, facilities, equipments or installations falling under the energy infrastructure categories; (4) \u2018project of common interest\u2019 means a project necessary to implement the energy infrastructure priority corridors and areas set out in Annex I and which is part of the Union list of projects of common interest referred to in Article 3; (5) \u2018energy infrastructure bottleneck\u2019 means limitation of physical flows in an energy system due to insufficient transmission capacity, which includes inter alia the absence of infrastructure; (6) \u2018project promoter\u2019 means one of the following: (a) a TSO, distribution system operator or other operator or investor developing a project of common interest; (b) where there are several TSOs, distribution system operators, other operators, investors, or any group thereof, the entity with legal personality under the applicable national law, which has been designated by contractual arrangement between them and which has the capacity to undertake legal obligations and assume financial liability on behalf of the parties to the contractual arrangement; (7) \u2018smart grid\u2019 means an electricity network that can integrate in a cost efficient manner the behaviour and actions of all users connected to it, including generators, consumers and those that both generate and consume, in order to ensure an economically efficient and sustainable power system with low losses and high levels of quality, security of supply and safety; (8) \u2018works\u2019 means the purchase, supply and deployment of components, systems and services including software, the carrying out of development and construction and installation activities relating to a project, the acceptance of installations and the launching of a project; (9) \u2018studies\u2019 means activities needed to prepare project implementation, such as preparatory, feasibility, evaluation, testing and validation studies, including software, and any other technical support measure including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package; (10) \u2018national regulatory authority\u2019 means a national regulatory authority designated in accordance with Article 35(1) of Directive 2009/72/EC or Article 39(1) of Directive 2009/73/EC; (11) \u2018commissioning\u2019 means the process of bringing a project into operation once it has been constructed. CHAPTER II PROJECTS OF COMMON INTEREST Article 3 Union list of projects of common interest 1. This Regulation establishes twelve Regional Groups (\u2018Groups\u2019) as set out in Annex III.1. The membership of each Group shall be based on each priority corridor and area and their respective geographical coverage as set out in Annex I. Decision-making powers in the Groups shall be restricted to Member States and the Commission, who shall, for those purposes, be referred to as the decision-making body of the Groups. 2. Each Group shall adopt its own rules of procedure, having regard to the provisions set out in Annex III. 3. The decision-making body of each Group shall adopt a regional list of proposed projects of common interest drawn up according to the process set out in Annex III.2, according to the contribution of each project to implementing the energy infrastructure priority corridors and areas and according to their fulfilment of the criteria set out in Article 4. When a Group draws up its regional list: (a) each individual proposal for a project of common interest shall require the approval of the Member States, to whose territory the project relates; if a Member State decides not to give its approval, it shall present its substantiated reasons for doing so to the Group concerned; (b) it shall take into account advice from the Commission that is aimed at having a manageable total number of projects of common interest. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 16 that establish the Union list of projects of common interest (\u2018Union list\u2019), subject to the second paragraph of Article 172 of the TFEU. The Union list shall take the form of an annex to this Regulation. In exercising its power, the Commission shall ensure that the Union list is established every two years, on the basis of the regional lists adopted by the decision-making bodies of the Groups as established in Annex III.1(2), following the procedure set out in paragraph 3 of this Article. The first Union list shall be adopted by 30 September 2013. 5. The Commission shall, when adopting the Union list on the basis of the regional lists: (a) ensure that only those projects that fulfil the criteria referred to in Article 4 are included; (b) ensure cross-regional consistency, taking into account the opinion of the Agency as referred to in Annex III.2(12); (c) take into account any opinions of Member States as referred to in Annex III.2(9); and (d) aim for a manageable total number of projects of common interest on the Union list. 6. Projects of common interest included on the Union list pursuant to paragraph 4 of this Article shall become an integral part of the relevant regional investment plans under Article 12 of Regulations (EC) No 714/2009 and (EC) No 715/2009 and of the relevant national 10-year network development plans under Article 22 of Directives 2009/72/EC and 2009/73/EC and other national infrastructure plans concerned, as appropriate. Those projects shall be conferred the highest possible priority within each of those plans. Article 4 Criteria for projects of common interest 1. Projects of common interest shall meet the following general criteria: (a) the project is necessary for at least one of the energy infrastructure priority corridors and areas; (b) the potential overall benefits of the project, assessed according to the respective specific criteria in paragraph 2, outweigh its costs, including in the longer term; and (c) the project meets any of the following criteria: (i) involves at least two Member States by directly crossing the border of two or more Member States; (ii) is located on the territory of one Member State and has a significant cross-border impact as set out in Annex IV.1; (iii) crosses the border of at least one Member State and a European Economic Area country. 2. The following specific criteria shall apply to projects of common interest falling within specific energy infrastructure categories: (a) for electricity transmission and storage projects falling under the energy infrastructure categories set out in Annex II.1(a) to (d), the project is to contribute significantly to at least one of the following specific criteria: (i) market integration, inter alia through lifting the isolation of at least one Member State and reducing energy infrastructure bottlenecks; competition and system flexibility; (ii) sustainability, inter alia through the integration of renewable energy into the grid and the transmission of renewable generation to major consumption centres and storage sites; (iii) security of supply, inter alia through interoperability, appropriate connections and secure and reliable system operation; (b) for gas projects falling under the energy infrastructure categories set out in Annex II.2, the project is to contribute significantly to at least one of the following specific criteria: (i) market integration, inter alia through lifting the isolation of at least one Member State and reducing energy infrastructure bottlenecks; interoperability and system flexibility; (ii) security of supply, inter alia through appropriate connections and diversification of supply sources, supplying counterparts and routes; (iii) competition, inter alia through diversification of supply sources, supplying counterparts and routes; (iv) sustainability, inter alia through reducing emissions, supporting intermittent renewable generation and enhancing deployment of renewable gas; (c) for electricity smart grid projects falling under the energy infrastructure category set out in Annex II.1(e), the project is to contribute significantly to all of the following specific criteria: (i) integration and involvement of network users with new technical requirements with regard to their electricity supply and demand; (ii) efficiency and interoperability of electricity transmission and distribution in day-to-day network operation; (iii) network security, system control and quality of supply; (iv) optimised planning of future cost-efficient network investments; (v) market functioning and customer services; (vi) involvement of users in the management of their energy usage; (d) for oil transport projects falling under the energy infrastructure categories set out in Annex II.3, the project is to contribute significantly to all of the following specific criteria: (i) security of supply reducing single supply source or route dependency; (ii) efficient and sustainable use of resources through mitigation of environmental risks; (iii) interoperability; (e) for carbon dioxide transport projects falling under the energy infrastructure categories set out in Annex II.4, the project is contribute significantly to all of the following specific criteria: (i) the avoidance of carbon dioxide emissions while maintaining security of energy supply; (ii) increasing the resilience and security of carbon dioxide transport; (iii) the efficient use of resources, by enabling the connection of multiple carbon dioxide sources and storage sites via common infrastructure and minimising environmental burden and risks. 3. For projects falling under the energy infrastructure categories set out in Annex II.1 to 3, the criteria listed in this Article shall be assessed in accordance with the indicators set out in Annex IV.2 to 5. 4. In order to facilitate the assessing of all projects that could be eligible as projects of common interest and that could be included in a regional list, each Group shall assess each project\u2019s contribution to the implementation of the same priority corridor or area in a transparent and objective manner. Each Group shall determine its assessment method on the basis of the aggregated contribution to the criteria referred to in paragraph 2; this assessment shall lead to a ranking of projects for internal use of the Group. Neither the regional list nor the Union list shall contain any ranking, nor shall the ranking be used for any subsequent purpose except as described in Annex III.2(14). When assessing projects, each Group shall furthermore give due consideration to: (a) the urgency of each proposed project in order to meet the Union energy policy targets of market integration, inter alia through lifting the isolation of at least one Member State and competition, sustainability and security of supply; (b) the number of Member States affected by each project, whilst ensuring equal opportunities for projects involving peripheral Member States; (c) the contribution of each project to territorial cohesion; and (d) complementarity with regard to other proposed projects. For smart grids projects falling under the energy infrastructure category set out in Annex II.1(e), ranking shall be carried out for those projects that affect the same two Member States, and due consideration shall also be given to the number of users affected by the project, the annual energy consumption and the share of generation from non-dispatchable resources in the area covered by these users. Article 5 Implementation and monitoring 1. Project promoters shall draw up an implementation plan for projects of common interest, including a timetable for each of the following: (a) feasibility and design studies; (b) approval by the national regulatory authority or by any other authority concerned; (c) construction and commissioning; (d) the permit granting schedule referred to in Article 10(4)(b). 2. TSOs, distribution system operators and other operators shall co-operate with each other in order to facilitate the development of projects of common interest in their area. 3. The Agency and the Groups concerned shall monitor the progress achieved in implementing the projects of common interest and, if necessary, make recommendations to facilitate the implementation of projects of common interest. The Groups may request that additional information be provided in accordance with paragraphs 4, 5 and 6, convene meetings with the relevant parties and invite the Commission to verify the information provided on site. 4. By 31 March of each year following the year of inclusion of a project of common interest on the Union list pursuant to Article 3, project promoters shall submit an annual report, for each project falling under the categories set out in Annex II.1 and 2, to the competent authority referred to in Article 8 and either to the Agency or, for projects falling under the categories set out in Annex II.3 and 4, to the respective Group. That report shall give details of: (a) the progress achieved in the development, construction and commissioning of the project, in particular with regard to permit granting and consultation procedures; (b) where relevant, delays compared to the implementation plan, the reasons for such delays and other difficulties encountered; (c) where relevant, a revised plan aiming at overcoming the delays. 5. Within three months of the receipt of the annual reports referred to in paragraph 4 of this Article, the Agency shall submit to the Groups a consolidated report for the projects of common interest falling under the categories set out in Annex II.1 and 2, evaluating the progress achieved and make, where appropriate, recommendations on how to overcome the delays and difficulties encountered. That consolidated report shall also evaluate, in accordance with Article 6(8) and (9) of Regulation (EC) No 713/2009, the consistent implementation of the Union-wide network development plans with regard to the energy infrastructure priority corridors and areas. 6. Each year, the competent authorities referred to in Article 8 shall report to the respective Group on the progress and, where relevant, on delays in the implementation of projects of common interest located on their respective territory with regard to the permit granting processes, and on the reasons for such delays. 7. If the commissioning of a project of common interest is delayed compared to the implementation plan, other than for overriding reasons beyond the control of the project promoter: (a) in so far as measures referred to in Article 22(7)(a), (b) or (c) of Directives 2009/72/EC and 2009/73/EC are applicable according to respective national laws, national regulatory authorities shall ensure that the investment is carried out; (b) if the measures of national regulatory authorities according to point (a) are not applicable, the project promoter shall choose a third party to finance or construct all or part of the project. The project promoter shall do so before the delay compared to the date of commissioning in the implementation plan exceeds two years; (c) if a third party is not chosen according to point (b), the Member State or, when the Member State has so provided, the national regulatory authority may, within two months of the expiry of the period referred to in point (b), designate a third party to finance or construct the project which the project promoter shall accept; (d) if the delay compared to the date of commissioning in the implementation plan exceeds two years and two months, the Commission, subject to the agreement and with the full cooperation of the Member States concerned, may launch a call for proposals open to any third party capable of becoming a project promoter to build the project according to an agreed timeline; (e) when points (c) or (d) are applied, the system operator in whose area the investment is located shall provide the implementing operators or investors or third party with all the information needed to realise the investment, shall connect new assets to the transmission network and shall generally make its best efforts to facilitate the implementation of the investment and the secure, reliable and efficient operation and maintenance of the project of common interest. 8. A project of common interest may be removed from the Union list according to the procedure set out in Article 3(4) if its inclusion in that list was based on incorrect information which was a determining factor for that inclusion, or the project does not comply with Union law. 9. Projects which are no longer on the Union list shall lose all rights and obligations linked to the status of project of common interest arising from this Regulation. However, a project which is no longer on the Union list but for which an application file has been accepted for examination by the competent authority shall maintain the rights and obligations arising from Chapter III, except where the project is no longer on the list for the reasons set out in paragraph 8. 10. This Article shall be without prejudice to any Union financial assistance granted to any project of common interest prior to its removal from the Union list. Article 6 European coordinators 1. Where a project of common interest encounters significant implementation difficulties, the Commission may designate, in agreement with the Member States concerned, a European coordinator for a period of up to one year renewable twice. 2. The European coordinator shall: (a) promote the projects, for which he has been designated European coordinator and the cross-border dialogue between the project promoters and all concerned stakeholders; (b) assist all parties as necessary in consulting concerned stakeholders and obtaining necessary permits for the projects; (c) if appropriate, advise project promoters on the financing of the project; (d) ensure that appropriate support and strategic direction by the Member States concerned are provided for the preparation and implementation of the projects; (e) submit every year, and if appropriate, upon completion of their mandate, a report to the Commission on the progress of the projects and on any difficulties and obstacles which are likely to significantly delay the commissioning date of the projects. The Commission shall transmit the report to the European Parliament and the Groups concerned. 3. The European coordinator shall be chosen on the basis of his experience with regard to the specific tasks assigned to him for the projects concerned. 4. The decision designating the European coordinator shall specify the terms of reference, detailing the duration of the mandate, the specific tasks and corresponding deadlines, and the methodology to be followed. The coordination effort shall be proportionate to the complexity and estimated costs of the projects. 5. The Member States concerned shall fully cooperate with the European coordinator in his execution of the tasks referred to in paragraphs 2 and 4. CHAPTER III PERMIT GRANTING AND PUBLIC PARTICIPATION Article 7 \u2018Priority status\u2019 of projects of common interest 1. The adoption of the Union list shall establish, for the purposes of any decisions issued in the permit granting process, the necessity of these projects from an energy policy perspective, without prejudice to the exact location, routing or technology of the project. 2. For the purpose of ensuring efficient administrative processing of the application files related to projects of common interest, project promoters and all authorities concerned shall ensure that the most rapid treatment legally possible is given to these files. 3. Where such status exists in national law, projects of common interest shall be allocated the status of the highest national significance possible and be treated as such in permit granting processes \u2014 and if national law so provides, in spatial planning \u2014 including those relating to environmental assessments, in the manner such treatment is provided for in national law applicable to the corresponding type of energy infrastructure. 4. By 16 August 2013, the Commission shall issue non-binding guidance to support Member States in defining adequate legislative and non-legislative measures to streamline the environmental assessment procedures and to ensure the coherent application of environmental assessment procedures required under Union law for projects of common interest. 5. Member States shall assess, taking due account of the guidance referred to in paragraph 4, which measures to streamline the environmental assessment procedures and to ensure their coherent application are possible, and shall inform the Commission of the result. 6. By nine months from the date of issue of the guidance referred to in paragraph 4, Member States shall take the non-legislative measures that they have identified under paragraph 5. 7. By 24 months from the date of issue of the guidance referred to in paragraph 4, Member States shall take the legislative measures that they have identified under paragraph 5. These measures shall be without prejudice to obligations resulting from Union law. 8. With regard to the environmental impacts addressed in Article 6(4) of Directive 92/43/EEC and Article 4(7) of Directive 2000/60/EC, projects of common interest shall be considered as being of public interest from an energy policy perspective, and may be considered as being of overriding public interest, provided that all the conditions set out in these Directives are fulfilled. Should the opinion of the Commission be required in accordance with Directive 92/43/EEC, the Commission and the competent authority referred to in Article 9 of this Regulation shall ensure that the decision with regard to the overriding public interest of a project is taken within the time limit pursuant to Article 10(1) of this Regulation. Article 8 Organisation of the permit granting process 1. By 16 November 2013, each Member State shall designate one national competent authority which shall be responsible for facilitating and coordinating the permit granting process for projects of common interest. 2. The responsibility of the competent authority referred to in paragraph 1 and/or the tasks related to it may be delegated to, or carried out by, another authority, per project of common interest or per particular category of projects of common interest, provided that: (a) the competent authority notifies the Commission of that delegation and the information therein is published by either the competent authority or the project promoter on the website referred to in Article 9(7); (b) only one authority is responsible per project of common interest, is the sole point of contact for the project promoter in the process leading to the comprehensive decision for a given project of common interest, and coordinates the submission of all relevant documents and information. The competent authority may retain the responsibility to establish time limits, without prejudice to the time limits set in accordance with Article 10. 3. Without prejudice to relevant requirements under international and Union law, the competent authority shall take actions to facilitate the issuing of the comprehensive decision. The comprehensive decision shall be issued within the time limit referred to in Article 10(1) and (2) and according to one of the following schemes: (a) integrated scheme: the comprehensive decision shall be issued by the competent authority and shall be the sole legally binding decision resulting from the statutory permit granting procedure. Where other authorities are concerned by the project, they may, in accordance with national law, give their opinion as input to the procedure, which shall be taken into account by the competent authority; (b) coordinated scheme: the comprehensive decision comprises multiple individual legally binding decisions issued by several authorities concerned, which shall be coordinated by the competent authority. The competent authority may establish a working group where all concerned authorities are represented in order to draw up a permit granting schedule in accordance with Article 10(4)(b), and to monitor and coordinate its implementation. The competent authority shall, in consultation with the other authorities concerned, where applicable in accordance with national law, and without prejudice to time limits set in accordance with Article 10, establish on a case-by-case basis a reasonable time limit within which the individual decisions shall be issued. The competent authority may take an individual decision on behalf of another national authority concerned, if the decision by that authority is not delivered within the time limit and if the delay cannot be adequately justified; or, where provided under national law, and to the extent that this is compatible with Union law, the competent authority may consider that another national authority concerned has either given its approval or refusal for the project if the decision by that authority is not delivered within the time limit. Where provided under national law, the competent authority may disregard an individual decision of another national authority concerned if it considers that the decision is not sufficiently substantiated with regard to the underlying evidence presented by the national authority concerned; when doing so, the competent authority shall ensure that the relevant requirements under international and Union law are respected and shall duly justify its decision; (c) collaborative scheme: the comprehensive decision shall be coordinated by the competent authority. The competent authority shall, in consultation with the other authorities concerned, where applicable in accordance with national law, and without prejudice to time limits set in accordance with Article 10, establish on a case-by-case basis a reasonable time limit within which the individual decisions shall be issued. It shall monitor compliance with the time limits by the authorities concerned. If an individual decision by an authority concerned is not expected to be delivered within the time limit, that authority shall inform the competent authority without delay and include a justification for the delay. Subsequently, the competent authority shall reset the time limit within which that individual decision shall be issued, whilst still complying with the overall time limits set in accordance with Article 10. Acknowledging the national specificities in planning and permit granting processes, Member States may choose among the three schemes referred to in points (a), (b) and (c) of the first subparagraph to facilitate and coordinate their procedures and shall opt to implement the most effective scheme. Where a Member State chooses the collaborative scheme, it shall inform the Commission of its reasons therefor. The Commission shall undertake an evaluation of the effectiveness of the schemes in the report referred to in Article 17. 4. Member States may apply different schemes as set out in paragraph 3 to onshore and offshore projects of common interest. 5. If a project of common interest requires decisions to be taken in two or more Member States, the respective competent authorities shall take all necessary steps for efficient and effective cooperation and coordination among themselves, including as regards the provisions referred to in Article 10(4). Member States shall endeavour to provide for joint procedures, particularly with regard to the assessment of environmental impacts. Article 9 Transparency and public participation 1. By 16 May 2014, the Member State or competent authority shall, where applicable in collaboration with other authorities concerned, publish a manual of procedures for the permit granting process applicable to projects of common interest. The manual shall be updated as necessary and made available to the public. The manual shall at least include the information specified in Annex VI.1. The manual shall not be legally binding, but it may refer to or quote relevant legal provisions. 2. Without prejudice to any requirements under the Aarhus and Espoo Conventions and relevant Union law, all parties involved in the permit granting process shall follow the principles for public participation set out in of Annex VI.3. 3. The project promoter shall, within an indicative period of three months of the start of the permit granting process pursuant to Article 10(1)(a), draw up and submit a concept for public participation to the competent authority, following the process outlined in the manual referred to in paragraph 1 and in line with the guidelines set out in Annex VI. The competent authority shall request modifications or approve the concept for public participation within three months; in so doing, the competent authority shall take into consideration any form of public participation and consultation that took place before the start of the permit granting process, to the extent that such public participation and consultation has fulfilled the requirements of this Article. Where the project promoter intends to make significant changes to an approved concept, it shall inform the competent authority thereof. In that case the competent authority may request modifications. 4. At least one public consultation shall be carried out by the project promoter, or, where required by national law, by the competent authority, before submission of the final and complete application file to the competent authority pursuant to Article 10(1)(a). This shall be without prejudice to any public consultation to be carried out after submission of the request for development consent according to Article 6(2) of Directive 2011/92/EU. The public consultation shall inform stakeholders referred to in Annex VI.3(a) about the project at an early stage and shall help to identify the most suitable location or trajectory and the relevant issues to be addressed in the application file. The minimum requirements applicable to this public consultation are specified in Annex VI.5. The project promoter shall prepare a report summarising the results of activities related to the participation of the public prior to the submission of the application file, including those activities that took place before the start of the permit granting process. The project promoter shall submit that report together with the application file to the competent authority. Due account shall be taken of these results in the comprehensive decision. 5. For projects crossing the border of two or more Member States, the public consultations pursuant to paragraph 4 in each of the Member States concerned shall take place within a period of no more than two months from the date on which the first public consultation started. 6. For projects likely to have significant adverse cross-border impacts in one or more neighbouring Member States, where Article 7 of Directive 2011/92/EU and the Espoo Convention are applicable, the relevant information shall be made available to the competent authority of the neighbouring Member States. The competent authority of the neighbouring Member States shall indicate, in the notification process where appropriate, whether it, or any other authority concerned, wishes to participate in the relevant public consultation procedures. 7. The project promoter, or, where national law so provides, the competent authority, shall establish and regularly update a website with relevant information about the project of common interest, which shall be linked to the Commission website and which shall meet the requirements specified in Annex VI.6. Commercially sensitive information shall be kept confidential. Project promoters shall also publish relevant information by other appropriate information means to which the public has open access. Article 10 Duration and implementation of the permit granting process 1. The permit granting process shall consist of two procedures: (a) The pre-application procedure, covering the period between the start of the permit granting process and the acceptance of the submitted application file by the competent authority, shall take place within an indicative period of two years. This procedure shall include the preparation of any environmental reports to be prepared by the project promoters. For the purpose of establishing the start of the permit granting process, the project promoters shall notify the project to the competent authority of the Member States concerned in written form, and shall include a reasonably detailed outline of the project. No later than three months following the receipt of the notification, the competent authority shall, including on behalf of other authorities concerned, acknowledge or, if it considers the project as not mature enough to enter the permit granting process, reject the notification in written form. In the event of a rejection, the competent authority shall justify its decision, including on behalf of other authorities concerned. The date of signature of the acknowledgement of the notification by the competent authority shall serve as the start of the permit granting process. Where two or more Member States are concerned, the date of the acceptance of the last notification by the competent authority concerned shall serve as the date of the start of the permit granting process. (b) The statutory permit granting procedure, covering the period from the date of acceptance of the submitted application file until the comprehensive decision is taken, shall not exceed one year and six months. Member States may set an earlier date for the time-limit, if considered appropriate. 2. The combined duration of the two procedures referred to in paragraph 1 shall not exceed a period of three years and six months. However, where the competent authority considers that one or both of the two procedures of the permit granting process will not be completed before the time limits as set out in paragraph 1, it may decide, before their expiry and on a case by case basis, to extend one or both of those time limits by a maximum of nine months for both procedures combined. In that case, the competent authority shall inform the Group concerned and present to the Group concerned the measures taken or to be taken to conclude the permit granting process with the least possible delay. The Group may request the competent authority to report regularly on progress achieved in this regard. 3. In Member States where the determination of a route or location undertaken solely for the specific purpose of a planned project, including the planning of specific corridors for grid infrastructures, cannot be included in the process leading to the comprehensive decision, the corresponding decision shall be taken within a separate period of six months, starting on the date of submission of the final and complete application documents by the promoter. In that case, the extension period referred to in paragraph 2 shall be reduced to six months, including for the procedure referred to in this paragraph. 4. The pre-application procedure shall comprise the following steps: (a) upon the acknowledgement of the notification pursuant to paragraph 1(a), the competent authority shall identify, in close cooperation with the other authorities concerned, and where appropriate on the basis of a proposal by the project promoter, the scope of material and level of detail of information to be submitted by the project promoter, as part of the application file, to apply for the comprehensive decision. The checklist referred to in Annex VI.1(e) shall serve as a basis for this identification; (b) the competent authority shall draw up, in close cooperation with the project promoter and other authorities concerned and taking into account the results of the activities carried out under point (a), a detailed schedule for the permit granting process in line with the guidelines set out in Annex VI.(2); For projects crossing the border between two or more Member States, the competent authorities of the Member States concerned shall prepare a joint schedule, in which they endeavour to align their timetables; (c) upon receipt of the draft application file, the competent authority shall, if necessary, and including on behalf of other authorities concerned, make further requests regarding missing information to be submitted by the project promoter, which may only address subjects identified under point (a). Within three months of the submission of the missing information, the competent authority shall accept for examination the application in written form. Requests for additional information may only be made if they are justified by new circumstances. 5. The project promoter shall ensure the completeness and adequate quality of the application file and seek the competent authority\u2019s opinion on this as early as possible during the pre-application procedure. The project promoter shall cooperate fully with the competent authority to meet deadlines and comply with the detailed schedule as defined in paragraph 4(b). 6. The time limits laid down in this Article shall be without prejudice to obligations arising from international and Union law, and without prejudice to administrative appeal procedures and judicial remedies before a court or tribunal. CHAPTER IV REGULATORY TREATMENT Article 11 Energy system wide cost-benefit analysis 1. By 16 November 2013, the European Network of Transmission System Operators (ENTSO) for Electricity and the ENTSO for Gas shall publish and submit to Member States, the Commission and the Agency their respective methodologies, including on network and market modelling, for a harmonised energy system-wide cost-benefit analysis at Union level for projects of common interest falling under the categories set out in Annex II.1(a) to (d) and Annex II.2. Those methodologies shall be applied for the preparation of each subsequent 10-year network development plan developed by the ENTSO for Electricity or the ENTSO for Gas pursuant to Article 8 of Regulation (EC) No 714/2009 and Article 8 of Regulation (EC) No 715/2009. The methodologies shall be drawn up in line with the principles laid down in Annex V and be consistent with the rules and indicators set out in Annex IV. Prior to submitting their respective methodologies, the ENTSO for Electricity and the ENTSO for Gas shall conduct an extensive consultation process involving at least the organisations representing all relevant stakeholders \u2014 and, if deemed appropriate, the stakeholders themselves \u2014 national regulatory authorities and other national authorities. 2. Within three months of the day of receipt of the methodologies, the Agency shall provide an opinion to Member States and the Commission on the methodologies and publish it. 3. Within three months of the receipt of the opinion of the Agency, the Commission shall, and Member States may, deliver an opinion on the methodologies. The opinions shall be submitted to the ENTSO for Electricity or the ENTSO for Gas. 4. Within three months of the day of receipt of the last opinion received under paragraph 3, the ENTSO for Electricity and the ENTSO for Gas shall adapt their methodologies taking due account of the opinions received from Member States, the Commission\u2019s opinion and the Agency\u2019s opinion, and submit them to the Commission for approval. 5. Within two weeks of the approval by the Commission, the ENTSO for Electricity and the ENTSO for Gas shall publish their respective methodologies on their websites. They shall transmit the corresponding input data sets as defined in Annex V.1 and other relevant network, load flow and market data in a sufficiently accurate form according to national law and relevant confidentiality agreements to the Commission and the Agency, upon request. The data shall be valid at the date of the request. The Commission and the Agency shall ensure the confidential treatment of the data received, by themselves and by any party carrying out analytical work for them on the basis of those data. 6. The methodologies shall be updated and improved regularly in accordance with paragraphs 1 to 5. The Agency, on its own initiative or upon a duly reasoned request by national regulatory authorities or stakeholders, and after formally consulting the organisations representing all relevant stakeholders and the Commission, may request such updates and improvements with due justification and timescales. The Agency shall publish the requests by national regulatory authorities or stakeholders and all relevant non-commercially sensitive documents leading to a request from the Agency for an update or improvement. 7. By 16 May 2015, national regulatory authorities cooperating in the framework of the Agency shall establish and make publicly available a set of indicators and corresponding reference values for the comparison of unit investment costs for comparable projects of the infrastructure categories included in Annex II.1 and 2. Those reference values may be used by the ENTSO for Electricity and the ENTSO for Gas for the cost-benefit analyses carried out for subsequent 10-year network development plans. 8. By 31 December 2016, the ENTSO for Electricity and the ENTSO for Gas shall jointly submit to the Commission and the Agency a consistent and interlinked electricity and gas market and network model including both electricity and gas transmission infrastructure as well as storage and LNG facilities, covering the energy infrastructure priority corridors and areas and drawn up in line with the principles laid down in Annex V. After approval of this model by the Commission according to the procedure set out in paragraphs 2 to 4, it shall be included in the methodologies. Article 12 Enabling investments with cross-border impacts 1. The efficiently incurred investment costs, which excludes maintenance costs, related to a project of common interest falling under the categories set out in Annex II.1(a), (b) and (d) and Annex II.2 shall be borne by the relevant TSO or the project promoters of the transmission infrastructure of the Member States to which the project provides a net positive impact, and, to the extent not covered by congestion rents or other charges, be paid for by network users through tariffs for network access in that or those Member States. 2. For a project of common interest falling under the categories set out in Annex II.1(a), (b) and (d) and Annex II.2, paragraph 1 shall apply only if at least one project promoter requests the relevant national authorities to apply this Article for all or parts of the costs of the project. For a project of common interest falling under the categories set out in Annex II.2, paragraph 1 shall apply only where an assessment of market demand has already been carried out and indicated that the efficiently incurred investment costs cannot be expected to be covered by the tariffs. Where a project has several project promoters, the relevant national regulatory authorities shall without delay request all project promoters to submit the investment request jointly in accordance with paragraph 3. 3. For a project of common interest to which paragraph 1 applies, the project promoters shall keep all concerned national regulatory authorities regularly informed, at least once per year, and until the project is commissioned, of the progress of that project and the identification of costs and impacts associated with it. As soon as such a project has reached sufficient maturity, the project promoters, after having consulted the TSOs from the Member States to which the project provides a significant net positive impact, shall submit an investment request. That investment request shall include a request for a cross-border cost allocation and shall be submitted to all the national regulatory authorities concerned, accompanied by the following: (a) a project-specific cost-benefit analysis consistent with the methodology drawn up pursuant to Article 11 and taking into account benefits beyond the borders of the Member State concerned; (b) a business plan evaluating the financial viability of the project, including the chosen financing solution, and, for a project of common interest falling under the category referred to in Annex II.2, the results of market testing; and (c) if the project promoters agree, a substantiated proposal for a cross-border cost allocation. If a project is promoted by several project promoters, they shall submit their investment request jointly. For projects included in the first Union list, project promoters shall submit their investment request by 31 October 2013. A copy of each investment request shall be transmitted for information without delay by the national regulatory authorities to the Agency on receipt. The national regulatory authorities and the Agency shall preserve the confidentiality of commercially sensitive information. 4. Within six months of the date on which the last investment request was received by the national regulatory authorities concerned, the national regulatory authorities shall, after consulting the project promoters concerned, take coordinated decisions on the allocation of investment costs to be borne by each system operator for the project, as well as their inclusion in tariffs. The national regulatory authorities may decide to allocate only part of the costs, or may decide to allocate costs among a package of several projects of common interest. When allocating the costs, the national regulatory authorities shall take into account actual or estimated: \u2014 congestion rents or other charges, \u2014 revenues stemming from the inter-transmission system operator compensation mechanism established under Article 13 of Regulation (EC) No 714/2009. In deciding to allocate costs across borders, the economic, social and environmental costs and benefits of the projects in the Member States concerned and the possible need for financial support shall be taken into account. In deciding to allocate costs across borders, the relevant national regulatory authorities, in consultation with the TSOs concerned, shall seek a mutual agreement based on, but not limited to, the information specified in paragraph 3(a) and (b). If a project of common interest mitigates negative externalities, such as loop flows, and that project of common interest is implemented in the Member State at the origin of the negative externality, such mitigation shall not be regarded as a cross-border benefit and shall therefore not constitute a basis for allocating costs to the TSO of the Member States affected by those negative externalities. 5. National regulatory authorities shall, based on the cross-border cost allocation as referred to in paragraph 4 of this Article, take into account actual costs incurred by a TSO or other project promoter as a result of the investments when fixing or approving tariffs in accordance with Article 37(1)(a) of Directive 2009/72/EC and Article 41(1)(a) of Directive 2009/73/EC, insofar as these costs correspond to those of an efficient and structurally comparable operator. The cost allocation decision shall be notified, without delay, by the national regulatory authorities to the Agency, together with all the relevant information with respect to the decision. In particular, the information shall contain detailed reasons on the basis of which costs were allocated among Member States, such as the following: (a) an evaluation of the identified impacts, including concerning network tariffs, on each of the concerned Member States; (b) an evaluation of the business plan referred to in paragraph 3(b); (c) regional or Union-wide positive externalities, which the project would generate; (d) the result of the consultation of the project promoters concerned. The cost allocation decision shall be published. 6. Where the national regulatory authorities concerned have not reached an agreement on the investment request within six months of the date on which the request was received by the last of the national regulatory authorities concerned, they shall inform the Agency without delay. In this case or upon a joint request from the national regulatory authorities concerned, the decision on the investment request including cross-border cost allocation referred to in paragraph 3 as well as the way the cost of the investments are reflected in the tariffs shall be taken by the Agency within three months of the date of referral to the Agency. Before taking such a decision, the Agency shall consult the national regulatory authorities concerned and the project promoters. The three-month period referred to in the second subparagraph may be extended by an additional period of two months where further information is sought by the Agency. That additional period shall begin on the day following receipt of the complete information. The cost allocation decision shall be published. Articles 19 and 20 of Regulation (EC) No 713/2009 shall be applicable. 7. A copy of all cost allocation decisions, together with all the relevant information with respect to each decision, shall be notified, without delay, by the Agency to the Commission. That information may be submitted in aggregate form. The Commission shall preserve the confidentiality of commercially sensitive information. 8. This cost allocation decision shall not affect the right of TSOs to apply and national regulatory authorities to approve charges for access to networks in accordance with Article 32 of Directive 2009/72/EC and of Directive 2009/73/EC, Article 14 of Regulation (EC) No 714/2009, and Article 13 of Regulation (EC) No 715/2009. 9. This Article shall not apply to projects of common interest having received: (a) an exemption from Articles 32, 33, 34 and Article 41(6), (8) and (10) of Directive 2009/73/EC pursuant to Article 36 of Directive 2009/73/EC; (b) an exemption from Article 16(6) of Regulation (EC) No 714/2009 or an exemption from Article 32 and Article 37(6) and (10) of Directive 2009/72/EC pursuant to Article 17 of Regulation (EC) No 714/2009; (c) an exemption under Article 22 of Directive 2003/55/EC (20); or (d) an exemption under Article 7 of Regulation (EC) No 1228/2003 (21). Article 13 Incentives 1. Where a project promoter incurs higher risks for the development, construction, operation or maintenance of a project of common interest falling under the categories set out in Annex II.1(a), (b) and (d) and Annex II.2, compared to the risks normally incurred by a comparable infrastructure project, Member States and national regulatory authorities shall ensure that appropriate incentives are granted to that project in accordance with Article 37(8) of Directive 2009/72/EC, Article 41(8) of Directive 2009/73/EC, Article 14 of Regulation (EC) No 714/2009, and Article 13 of Regulation (EC) No 715/2009. The first subparagraph shall not apply where the project of common interest has received: (a) an exemption from Articles 32, 33, 34 and Article 41(6), (8) and (10) of Directive 2009/73/EC pursuant to Article 36 of Directive 2009/73/EC; (b) an exemption from Article 16(6) of Regulation (EC) No 714/2009 or an exemption from Article 32 and Article 37(6) and (10) of Directive 2009/72/EC pursuant to Article 17 of Regulation (EC) No 714/2009; (c) an exemption under Article 22 of Directive 2003/55/EC; or (d) an exemption under Article 7 of Regulation (EC) No 1228/2003. 2. The decision of the national regulatory authorities for granting the incentives referred to in paragraph 1 shall consider the results of the cost-benefit analysis on the basis of the methodology drawn up pursuant to Article 11 and in particular the regional or Union-wide positive externalities generated by the project. The national regulatory authorities shall further analyse the specific risks incurred by the project promoters, the risk mitigation measures taken and the justification of this risk profile in view of the net positive impact provided by the project, when compared to a lower-risk alternative. Eligible risks shall notably include risks related to new transmission technologies, both onshore and offshore, risks related to under-recovery of costs and development risks. 3. The incentive granted by the decision shall take account of the specific nature of the risk incurred and may cover inter alia: (a) the rules for anticipatory investment; or (b) the rules for recognition of efficiently incurred costs before commissioning of the project; or (c) the rules for providing additional return on the capital invested for the project; or (d) the any other measure deemed necessary and appropriate. 4. By 31 July 2013, each national regulatory authority shall submit to the Agency its methodology and the criteria used to evaluate investments in electricity and gas infrastructure projects and the higher risks incurred by them, where available. 5. By 31 December 2013, taking due account of the information received pursuant to paragraph 4 of this Article, the Agency shall facilitate the sharing of good practices and make recommendations in accordance with Article 7(2) of Regulation (EC) No 713/2009 regarding: (a) the incentives referred to in paragraph 1 on the basis of a benchmarking of best practice by national regulatory authorities; (b) a common methodology to evaluate the incurred higher risks of investments in electricity and gas infrastructure projects. 6. By 31 March 2014, each national regulatory authority shall publish its methodology and the criteria used to evaluate investments in electricity and gas infrastructure projects and the higher risks incurred by them. 7. Where the measures referred to in paragraphs 5 and 6 are not sufficient to ensure the timely implementation of projects of common interest, the Commission may issue guidelines regarding the incentives laid down in this Article. CHAPTER V FINANCING Article 14 Eligibility of projects for Union financial assistance 1. Projects of common interest falling under the categories set out in Annex II.1, 2 and 4 are eligible for Union financial assistance in the form of grants for studies and financial instruments. 2. Projects of common interest falling under the categories set out in Annex II.1(a) to (d) and Annex II.2, except for hydro-pumped electricity storage projects, are also eligible for Union financial assistance in the form of grants for works if they fulfil all of the following criteria: (a) the project specific cost-benefit analysis pursuant to Article 12(3)(a) provides evidence concerning the existence of significant positive externalities, such as security of supply, solidarity or innovation; (b) the project has received a cross-border cost allocation decision pursuant to Article 12; or, for projects of common interest falling under the category set out in Annex II.1(c) and that therefore do not receive a cross-border cost allocation decision, the project shall aim to provide services across borders, bring technological innovation and ensure the safety of cross-border grid operation; (c) the project is commercially not viable according to the business plan and other assessments carried out, notably by possible investors or creditors or the national regulatory authority. The decision on incentives and its justification referred to in Article 13(2) shall be taken into account when assessing the project\u2019s commercial viability. 3. Projects of common interest carried out in accordance with the procedure referred to in Article 5(7)(d) shall also be eligible for Union financial assistance in the form of grants for works if they fulfil the criteria set out in paragraph 2 of this Article. 4. Projects of common interest falling under the categories set out in Annex II.1(e) and 4 shall be also eligible for Union financial assistance in the form of grants for works, if the concerned project promoters can clearly demonstrate the significant positive externalities generated by the projects and their lack of commercial viability, according to the business plan and other assessments carried out, notably by possible investors or creditors or, where applicable, a national regulatory authority. Article 15 Guidance for the award criteria of Union financial assistance The specific criteria set out in Article 4(2) and the parameters set out in Article 4(4) shall also fulfil the role of objectives for the purpose of establishing award criteria for Union financial assistance in the relevant Regulation on a Connecting Europe Facility. Article 16 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3 shall be conferred on the Commission for a period of four years from 15 May 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of this period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 3 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 3 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. CHAPTER VI FINAL PROVISIONS Article 17 Reporting and evaluation Not later than 2017, the Commission shall publish a report on the implementation of projects of common interest and submit it to the European Parliament and the Council. This report shall provide an evaluation of: (a) the progress achieved for the planning, development, construction and commissioning of projects of common interest selected pursuant to Article 3, and, where relevant, delays in implementation and other difficulties encountered; (b) the funds engaged and disbursed by the Union for projects of common interest, compared to the total value of funded projects of common interest; (c) for the electricity and gas sectors, the evolution of the interconnection level between Member States, the corresponding evolution of energy prices, as well as the number of network system failure events, their causes and related economic cost; (d) permit granting and public participation, in particular: (i) the average and maximum total duration of permit granting processes for projects of common interest, including the duration of each step of the pre-application procedure, compared to the timing foreseen by the initial major milestones referred to in Article 10(4); (ii) the level of opposition faced by projects of common interest (notably number of written objections during the public consultation process, number of legal recourse actions); (iii) an overview of best and innovative practices with regard to stakeholder involvement and mitigation of environmental impact during permit granting processes and project implementation; (iv) the effectiveness of the schemes foreseen in Article 8(3) regarding compliance with the time limits set under Article 10; (e) regulatory treatment, in particular: (i) the number of projects of common interest having been granted a cross-border cost allocation decision pursuant to Article 12; (ii) the number and type of projects of common interest having received specific incentives pursuant to Article 13; (f) the effectiveness of this Regulation in contributing to the goals for market integration by 2014 and 2015, to the climate and energy targets for 2020, and, in the longer term, to the move toward a low-carbon economy by 2050. Article 18 Information and publicity The Commission shall establish by six months after the date of adoption of the first Union list an infrastructure transparency platform easily accessible to the general public, including via the internet. This platform shall contain the following information: (a) general, updated information, including geographic information, for each project of common interest; (b) the implementation plan as set out in Article 5(1) for each project of common interest; (c) the main results of the cost-benefit analysis on the basis of the methodology drawn up pursuant Article 11 for the projects of common interest concerned, except for any commercially sensitive information; (d) the Union list; (e) the funds allocated and disbursed by the Union for each project of common interest. Article 19 Transitional provisions This Regulation shall not affect the granting, continuation or modification of financial assistance awarded by the Commission on the basis of calls for proposals launched under Regulation (EC) No 680/2007 of the European Parliament and of the Council of 20 June 2007 laying down general rules for the granting of Community financial aid in the field of the trans-European transport and energy networks (22) to projects listed in Annexes I and III to Decision No 1364/2006/EC or in view of the targets, based on the relevant categories of expenditure for TEN-E, as defined in Council Regulation (EC) No 1083/2006 of 11 July 2006 laying down general provisions on the European Regional Development Fund, the European Social Fund and the Cohesion Fund (23). For projects of common interest in the permit granting process for which a project promoter has submitted an application file before 16 November 2013, the provisions of Chapter III shall not apply. Article 20 Amendments to Regulation (EC) No 713/2009 In Regulation (EC) No 713/2009, paragraph 1 of Article 22 is replaced by the following: \u20181. Fees shall be due to the Agency for requesting an exemption decision pursuant to Article 9(1) and for decisions on cross border cost allocation provided by the Agency pursuant to Article 12 of Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure (24). Article 21 Amendments to Regulation (EC) No 714/2009 Regulation (EC) No 714/2009 is hereby amended as follows: (1) Article 8 is amended as follows: (a) in paragraph 3, point (a) is replaced by the following: \u2018(a) common network operation tools to ensure coordination of network operation in normal and emergency conditions, including a common incident classification scale, and research plans. These tools shall specify inter alia: (i) the information, including appropriate day ahead, intra-day and real-time information, useful for improving operational coordination, as well as the optimal frequency for the collection and sharing of such information; (ii) the technological platform for the exchange of information in real time and where appropriate, the technological platforms for the collection, processing and transmission of the other information referred to in point (i), as well as for the implementation of the procedures capable of increasing operational coordination between transmission system operators with a view to such coordination becoming Union-wide; (iii) how transmission system operators make available the operational information to other transmission system operators or any entity duly mandated to support them to achieve operational coordination, and to the Agency; and (iv) that transmission system operators designate a contact point in charge of answering inquiries from other transmission system operators or from any entity duly mandated as referred to in point (iii), or from the Agency concerning such information. The ENTSO for Electricity shall submit the adopted specifications on points (i) to (iv) above to the Agency and to the Commission by 16 May 2015. Within 12 months of the adoption of the specifications, the Agency shall issue an opinion in which it considers whether they sufficiently contribute to the promotion of cross-border trade and to ensuring the optimal management, coordinated operation, efficient use and sound technical evolution of the European electricity transmission network.\u2019; (b) in paragraph 10 point (a) is replaced by the following: \u2018(a) build on national investment plans, taking into account regional investment plans as referred to in Article 12(1), and, if appropriate, Union aspects of network planning as set out in Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure (25); it shall be subject to a cost-benefit analysis using the methodology established as set out in Article 11 of that Regulation; (2) Article 11 is replaced by the following: \u2018Article 11 Costs The costs related to the activities of the ENTSO for Electricity referred to in Articles 4 to 12 of this Regulation, and in Article 11 of Regulation (EU) No 347/2013 shall be borne by the transmission system operators and shall be taken into account in the calculation of tariffs. Regulatory authorities shall approve those costs only if they are reasonable and appropriate.\u2019; (3) in Article 18, the following paragraph is inserted: \u20184a. The Commission may adopt guidelines on the implementation of operational coordination between transmission system operators at Union level. Those guidelines shall be consistent with and build upon the network codes referred to in Article 6 of this Regulation and build upon the adopted specifications and the Agency opinion referred to in Article 8(3)(a) of this Regulation. When adopting those guidelines, the Commission shall take into account differing regional and national operational requirements. Those guidelines shall be adopted in accordance with the examination procedure referred to in Article 23(3).\u2019; (4) in Article 23 the following paragraph is inserted: \u20183. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (26) shall apply. Article 22 Amendments to Regulation (EC) No 715/2009 Regulation (EC) No 715/2009 is amended as follows: (1) in Article 8(10), point (a) is replaced by the following: \u2018(a) build on national investment plans, taking into account regional investment plans as referred to in Article 12(1), and, if appropriate, Union aspects of network planning as set out in Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure (27); it shall be the subject to a cost-benefit analysis using the methodology established as set out in Article 11 of that Regulation. (2) Article 11 is replaced by the following: \u2018Article 11 Costs The costs related to the activities of the ENTSO for Gas referred to in Articles 4 to 12 of this Regulation, and in Article 11 of Regulation (EU) No 347/2013 shall be borne by the transmission system operators and shall be taken into account in the calculation of tariffs. Regulatory authorities shall approve those costs only if they are reasonable and appropriate.\u2019. Article 23 Repeal Decision No 1364/2006/EC is hereby repealed from 1 January 2014. No rights shall arise under this Regulation for projects listed in Annexes I and III to Decision No 1364/2006/EC. Article 24 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 June 2013 with the exception of Articles 14 and 15 which shall apply as from the date of application of the relevant Regulation on a Connecting Europe Facility. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 17 April 2013. For the European Parliament The President M. SCHULZ For the Council The President L. CREIGHTON (1) OJ C 143, 22.5.2012, p. 125. (2) OJ C 277, 13.9.2012, p. 137. (3) Position of the European Parliament of 12 March 2013 (not yet published in the Official Journal) and decision of the Council of 21 March 2013. (4) European Parliament resolution of 5 July 2011 on energy infrastructure priorities for 2020 and beyond (OJ C 33 E, 5.2.2013, p. 46). (5) OJ L 262, 22.9.2006, p. 1. (6) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources (OJ L 140, 5.6.2009, p. 16). (7) OJ L 211, 14.8.2009, p. 55. (8) OJ L 211, 14.8.2009, p. 94. (9) OJ L 345, 23.12.2008, p. 75. (10) OJ L 211, 14.8.2009, p. 15. (11) OJ L 55, 28.2.2011, p. 13. (12) OJ L 211, 14.8.2009, p. 1. (13) OJ L 206, 22.7.1992, p. 7. (14) OJ L 327, 22.12.2000, p. 1. (15) OJ L 26, 28.1.2012, p. 1. (16) OJ L 197, 21.7.2001, p. 30. (17) OJ L 124, 17.5.2005, p. 4. (18) OJ L 211, 14.8.2009, p. 36. (19) OJ L 200, 31.7.2009, p. 31. (20) Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas (OJ L 176, 15.7.2003, p. 57). (21) Regulation (EC) No 1228/2003 of the European Parliament and of the Council of 26 June 2003 on conditions for access to the network for cross-border exchanges in electricity (OJ L 176, 15.7.2003, p. 1). (22) OJ L 162, 22.6.2007, p. 1. (23) OJ L 210, 31.7.2006, p. 25. (24) OJ L 115, 25.4.2013, p. 39.\u2019. (25) OJ L 115, 25.4.2013, p. 39.\u2019; (26) OJ L 55, 28.2.2011, p. 13.\u2019. (27) OJ L 115, 25.4.2013, p. 39.\u2019; ANNEX I ENERGY INFRASTRUCTURE PRIORITY CORRIDORS AND AREAS This Regulation shall apply to the following trans-European energy infrastructure priority corridors and areas: 1. PRIORITY ELECTRICITY CORRIDORS (1) Northern Seas offshore grid (\u2018NSOG\u2019): integrated offshore electricity grid development and the related interconnectors in the North Sea, the Irish Sea, the English Channel, the Baltic Sea and neighbouring waters to transport electricity from renewable offshore energy sources to centres of consumption and storage and to increase cross-border electricity exchange. Member States concerned: Belgium, Denmark, France, Germany, Ireland, Luxemburg, the Netherlands, Sweden, the United Kingdom; (2) North-South electricity interconnections in Western Europe (\u2018NSI West Electricity\u2019): interconnections between Member States of the region and with the Mediterranean area including the Iberian peninsula, notably to integrate electricity from renewable energy sources and reinforce internal grid infrastructures to foster market integration in the region. Member States concerned: Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Malta, Portugal, Spain, the United Kingdom; (3) North-South electricity interconnections in Central Eastern and South Eastern Europe (\u2018NSI East Electricity\u2019): interconnections and internal lines in North-South and East-West directions to complete the internal market and integrate generation from renewable energy sources. Member States concerned: Austria, Bulgaria, Croatia (1), Czech Republic, Cyprus, Germany, Greece, Hungary, Italy, Poland, Romania, Slovakia, Slovenia; (4) Baltic Energy Market Interconnection Plan in electricity (\u2018BEMIP Electricity\u2019): interconnections between Member States in the Baltic region and reinforcing internal grid infrastructures accordingly, to end isolation of the Baltic States and to foster market integration inter alia by working towards the integration of renewable energy in the region. Member States concerned: Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Poland, Sweden. 2. PRIORITY GAS CORRIDORS (5) North-South gas interconnections in Western Europe (\u2018NSI West Gas\u2019): gas infrastructure for North-South gas flows in Western Europe to further diversify routes of supply and for increasing short-term gas deliverability. Member States concerned: Belgium, Denmark, France, Germany, Ireland, Italy, Luxembourg, Malta, the Netherlands, Portugal, Spain, the United Kingdom; (6) North-South gas interconnections in Central Eastern and South Eastern Europe (\u2018NSI East Gas\u2019): gas infrastructure for regional connections between and in the Baltic Sea region, the Adriatic and Aegean Seas, the Eastern Mediterranean Sea and the Black Sea, and for enhancing diversification and security of gas supply. Member States concerned: Austria, Bulgaria, Croatia (1), Cyprus, Czech Republic, Germany, Greece, Hungary, Italy, Poland, Romania, Slovakia, Slovenia; (7) Southern Gas Corridor (\u2018SGC\u2019): infrastructure for the transmission of gas from the Caspian Basin, Central Asia, the Middle East and the Eastern Mediterranean Basin to the Union to enhance diversification of gas supply. Member States concerned: Austria, Bulgaria, Croatia (2), Czech Republic, Cyprus, France, Germany, Hungary, Greece, Italy, Poland, Romania, Slovakia, Slovenia; (8) Baltic Energy Market Interconnection Plan in gas (\u2018BEMIP Gas\u2019): gas infrastructure to end the isolation of the three Baltic States and Finland and their dependency on a single supplier, to reinforce internal grid infrastructures accordingly, and to increase diversification and security of supplies in the Baltic Sea region. Member States concerned: Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Poland, Sweden. 3. PRIORITY OIL CORRIDOR (9) Oil supply connections in Central Eastern Europe (\u2018OSC\u2019): interoperability of the oil pipeline network in Central Eastern Europe to increase security of supply and reduce environmental risks. Member States concerned: Austria, Croatia (2), Czech Republic, Germany, Hungary, Poland, Slovakia. 4. PRIORITY THEMATIC AREAS (10) Smart grids deployment: adoption of smart grid technologies across the Union to efficiently integrate the behaviour and actions of all users connected to the electricity network, in particular the generation of large amounts of electricity from renewable or distributed energy sources and demand response by consumers. Member States concerned: all; (11) Electricity highways: first electricity highways by 2020, in view of building an electricity highways system across the Union that is capable of: (a) accommodating ever-increasing wind surplus generation in and around the Northern and Baltic Seas and increasing renewable generation in the East and South of Europe and also North Africa; (b) connecting these new generation hubs with major storage capacities in the Nordic countries, the Alps and other regions with major consumption centres; and (c) coping with an increasingly variable and decentralised electricity supply and flexible electricity demand. Member States concerned: all; (12) Cross-border carbon dioxide network: development of carbon dioxide transport infrastructure between Member States and with neighbouring third countries in view of the deployment of carbon dioxide capture and storage. Member States concerned: all. (1) Subject to and as of the date of accession of Croatia. (2) Subject to and as of the date of accession of Croatia. ANNEX II ENERGY INFRASTRUCTURE CATEGORIES The energy infrastructure categories to be developed in order to implement the energy infrastructure priorities listed in Annex I are the following: (1) concerning electricity: (a) high-voltage overhead transmission lines, if they have been designed for a voltage of 220 kV or more, and underground and submarine transmission cables, if they have been designed for a voltage of 150 kV or more; (b) concerning in particular electricity highways; any physical equipment designed to allow transport of electricity on the high and extra-high voltage level, in view of connecting large amounts of electricity generation or storage located in one or several Member States or third countries with large-scale electricity consumption in one or several other Member States; (c) electricity storage facilities used for storing electricity on a permanent or temporary basis in above-ground or underground infrastructure or geological sites, provided they are directly connected to high-voltage transmission lines designed for a voltage of 110 kV or more; (d) any equipment or installation essential for the systems defined in (a) to (c) to operate safely, securely and efficiently, including protection, monitoring and control systems at all voltage levels and substations; (e) any equipment or installation, both at transmission and medium voltage distribution level, aiming at two-way digital communication, real-time or close to real-time, interactive and intelligent monitoring and management of electricity generation, transmission, distribution and consumption within an electricity network in view of developing a network efficiently integrating the behaviour and actions of all users connected to it \u2014 generators, consumers and those that do both \u2014 in order to ensure an economically efficient, sustainable electricity system with low losses and high quality and security of supply and safety; (2) concerning gas: (a) transmission pipelines for the transport of natural gas and bio gas that form part of a network which mainly contains high-pressure pipelines, excluding high-pressure pipelines used for upstream or local distribution of natural gas; (b) underground storage facilities connected to the above-mentioned high-pressure gas pipelines; (c) reception, storage and regasification or decompression facilities for liquefied natural gas (LNG) or compressed natural gas (CNG); (d) any equipment or installation essential for the system to operate safely, securely and efficiently or to enable bi-directional capacity, including compressor stations; (3) concerning oil: (a) pipelines used to transport crude oil; (b) pumping stations and storage facilities necessary for the operation of crude oil pipelines; (c) any equipment or installation essential for the system in question to operate properly, securely and efficiently, including protection, monitoring and control systems and reverse-flow devices; (4) concerning carbon dioxide: (a) dedicated pipelines, other than upstream pipeline network, used to transport anthropogenic carbon dioxide from more than one source, i.e. industrial installations (including power plants) that produce carbon dioxide gas from combustion or other chemical reactions involving fossil or non-fossil carbon-containing compounds, for the purpose of permanent geological storage of carbon dioxide pursuant to Directive 2009/31/EC of the European Parliament and of the Council (1); (b) facilities for liquefaction and buffer storage of carbon dioxide in view of its further transportation. This does not include infrastructure within a geological formation used for the permanent geological storage of carbon dioxide pursuant to Directive 2009/31/EC and associated surface and injection facilities; (c) any equipment or installation essential for the system in question to operate properly, securely and efficiently, including protection, monitoring and control systems. (1) OJ L 140, 5.6.2009, p. 114. ANNEX III REGIONAL LISTS OF PROJECTS OF COMMON INTEREST 1. RULES FOR GROUPS (1) For electricity projects falling under the categories set out in Annex II.1, each Group shall be composed of representatives of the Member States, national regulatory authorities, TSOs, as well as the Commission, the Agency and the ENTSO for Electricity. For gas projects falling under the categories set out in Annex II.2, each Group shall be composed of representatives of the Member States, national regulatory authorities, TSOs, as well as the Commission, the Agency and the ENTSO for Gas. For oil and carbon dioxide transport projects falling under the categories referred to in Annex II.3 and 4, each Group shall be composed of the representatives of the Member States, project promoters concerned by each of the relevant priorities designated in Annex I and the Commission. (2) The decision-making bodies of the Groups may merge. All Groups or decision-making bodies shall meet together, when relevant, to discuss matters common to all Groups; such matters may include issues relevant to cross-regional consistency or the number of proposed projects included on the draft regional lists at risk of becoming unmanageable. (3) Each Group shall organise its work in line with regional cooperation efforts pursuant Article 6 of Directive 2009/72/EC, Article 7 of Directive 2009/73/EC, Article 12 of Regulation (EC) No 714/2009, and Article 12 of Regulation (EC) No 715/2009 and other existing regional cooperation structures. (4) Each Group shall invite, as appropriate in view of implementing the relevant priority designated in Annex I, promoters of a project potentially eligible for selection as a project of common interest as well as representatives of national administrations, of regulatory authorities, and TSOs from EU candidate countries and potential candidates, the member countries of the European Economic Area and the European Free Trade Association, representatives from the Energy Community institutions and bodies, countries covered by the European Neighbourhood policy and countries, with which the Union has established specific energy cooperation. The decision to invite third country-representatives shall be based on consensus. (5) Each Group shall consult the organisations representing relevant stakeholders \u2014 and, if deemed appropriate, stakeholders directly \u2014 including producers, distribution system operators, suppliers, consumers, and organisations for environmental protection. The Group may organise hearings or consultations, where relevant for the accomplishments of its tasks. (6) The internal rules, an updated list of member organisations, regularly updated information on the progress of work, meeting agendas, as well as final conclusions and decisions of each Group shall be published by the Commission on the transparency platform referred to in Article 18. (7) The Commission, the Agency and the Groups shall strive for consistency between the different Groups. For this purpose, the Commission and the Agency shall ensure, when relevant, the exchange of information on all work representing an interregional interest between the Groups concerned. The participation of national regulatory authorities and the Agency in the Groups shall not jeopardise the fulfilment of their objectives and duties under this Regulation or under Articles 36 and 37 of Directive 2009/72/EC and Articles 40 and 41 of Directive 2009/73/EC, or under Regulation (EC) No 713/2009. 2. PROCESS FOR ESTABLISHING REGIONAL LISTS (1) Promoters of a project potentially eligible for selection as a project of common interest wanting to obtain the status of projects of common interest shall submit an application for selection as project of common interest to the Group that includes: \u2014 an assessment of their projects with regard to the contribution to implementing the priorities set out in Annex I, \u2014 an analysis of the fulfilment of the relevant criteria defined in Article 4, \u2014 for projects having reached a sufficient degree of maturity, a project-specific cost-benefit analysis in accordance with Articles 21 and 22 based on the methodologies developed by the ENTSO for electricity or the ENTSO for gas pursuant to Article 11, and \u2014 any other relevant information for the evaluation of the project. (2) All recipients shall preserve the confidentiality of commercially sensitive information. (3) After adoption of the first Union list, for all subsequent Union lists adopted, proposed electricity transmission and storage projects falling under the categories set out in Annex II.1(a), (b) and (d) shall be part of the latest available 10-year network development plan for electricity, developed by the ENTSO for Electricity pursuant Article 8 of Regulation (EC) No 714/2009. (4) After adoption of the first Union list, for all subsequent Union lists adopted, proposed gas infrastructure projects falling under the categories set out in Annex II.2 shall be part of the latest available 10-year network development plan for gas, developed by the ENTSO for Gas pursuant Article 8 of Regulation (EC) No 715/2009. (5) The project proposals submitted for inclusion in the first Union list which were not previously evaluated pursuant to Article 8 of Regulation (EC) No 714/2009 shall be assessed at Union-wide system level by: \u2014 the ENTSO for Electricity in line with the methodology applied in the latest available 10-year network development plan for projects falling under Annex II.1(a), (b) and (d), \u2014 the ENTSO for Gas or by a third party in a consistent manner based on an objective methodology for projects falling under Annex II.2. By 16 January 2014, the Commission shall issue Guidelines on criteria to be applied by the ENTSO for electricity and the ENTSO for gas when developing their respective 10-year network development plans referred to in points (3) and (4), in order to ensure equal treatment and transparency of the process. (6) Proposed carbon dioxide transport projects falling under the category set out in Annex II.4 shall be presented as part of a plan, developed by at least two Member States, for the development of cross-border carbon dioxide transport and storage infrastructure, to be presented by the Member States concerned or entities designated by those Member States to the Commission. (7) For proposed projects falling under the categories set out in Annex II.1 and 2, national regulatory authorities, and if necessary the Agency, shall, where possible in the context of regional cooperation (Article 6 of Directive 2009/72/EC, Article 7 of Directive 2009/73/EC), check the consistent application of the criteria/ cost-benefit analysis methodology and evaluate their cross-border relevance. They shall present their assessment to the Group. (8) For proposed oil and carbon dioxide transport projects falling under the categories set out in Annex II.3 and 4, the Commission shall evaluate the application of the criteria set out in Article 4. For proposed carbon dioxide projects falling under the category set out in Annex II.4, the Commission shall also take into account the potential for future extension to include additional Member States. The Commission shall present its assessment to the Group. (9) Each Member State to whose territory a proposed project does not relate, but on which the proposed project may have a potential net positive impact or a potential significant effect, such as on the environment or on the operation of the energy infrastructure on its territory, may present an opinion to the Group specifying its concerns. (10) The decision-making body of the Group shall examine, at the request of a Member State of the Group, the substantiated reasons presented by a Member State pursuant to Article 3(3) for not approving a project of common interest related to its territory. (11) The Group shall meet to examine and rank the proposed projects taking into account the assessment of the regulators, or the assessment of the Commission for oil and carbon dioxide transport projects. (12) The draft regional lists of proposed projects falling under the categories set out in Annex II.1 and 2 drawn up by the Groups, together with any opinions as specified in point (9), shall be submitted to the Agency six months before the adoption date of the Union list. The draft regional lists and the accompanying opinions shall be assessed by the Agency within three months of the date of receipt. The Agency shall provide an opinion on the draft regional lists, in particular on the consistent application of the criteria and the cost-benefit analysis across regions. The opinion of the Agency shall be adopted in accordance with the procedure referred to in Article 15(1) of Regulation (EC) No 713/2009. (13) Within one month of the date of receipt of the Agency\u2019s opinion, the decision-making body of each Group shall adopt its final regional list, respecting the provisions set out in Article 3(3), based on the Groups\u2019 proposal and taking into account the opinion of the Agency and the assessment of the national regulatory authorities submitted in accordance with point (7), or the assessment of the Commission for oil and carbon dioxide transport projects proposed in accordance with point (8). The Groups shall submit the final regional lists to the Commission, together with any opinions as specified in point (9). (14) If, based on the regional lists received, and after having taken into account the Agency opinion, the total number of proposed projects of common interest on the Union list would exceed a manageable number, the Commission shall consider, after having consulted each Group concerned, not to include in the Union list projects that were ranked lowest by the Group concerned according to the ranking established pursuant to Article 4(4). ANNEX IV RULES AND INDICATORS CONCERNING CRITERIA FOR PROJECTS OF COMMON INTEREST (1) A project with significant cross-border impact is a project on the territory of a Member State, which fulfils the following conditions: (a) for electricity transmission, the project increases the grid transfer capacity, or the capacity available for commercial flows, at the border of that Member State with one or several other Member States, or at any other relevant cross-section of the same transmission corridor having the effect of increasing this cross-border grid transfer capacity, by at least 500 Megawatt compared to the situation without commissioning of the project; (b) for electricity storage, the project provides at least 225 MW installed capacity and has a storage capacity that allows a net annual electricity generation of 250 Gigawatt-hours/year; (c) for gas transmission, the project concerns investment in reverse flow capacities or changes the capability to transmit gas across the borders of the Member States concerned by at least 10 % compared to the situation prior to the commissioning of the project; (d) for gas storage or liquefied/compressed natural gas, the project aims at supplying directly or indirectly at least two Member States or at fulfilling the infrastructure standard (N-1 rule) at regional level in accordance with Article 6(3) of Regulation (EU) No 994/2010 of the European Parliament and of the Council (1); (e) for smart grids, the project is designed for equipments and installations at high-voltage and medium-voltage level designed for a voltage of 10 kV or more. It involves transmission and distribution system operators from at least two Member States, which cover at least 50 000 users that generate or consume electricity or do both in a consumption area of at least 300 Gigawatthours/year, of which at least 20 % originate from renewable resources that are variable in nature. (2) Concerning projects falling under the categories set out in Annex II.1(a) to (d), the criteria listed in Article 4 shall be evaluated as follows: (a) Market integration, competition and system flexibility shall be measured in line with the analysis made in the latest available Union-wide 10-year network development plan in electricity, notably by: \u2014 calculating, for cross-border projects, the impact on the grid transfer capability in both power flow directions, measured in terms of amount of power (in megawatt), and their contribution to reaching the minimum interconnection capacity of 10 % installed production capacity or, for projects with significant cross-border impact, the impact on grid transfer capability at borders between relevant Member States, between relevant Member States and third countries or within relevant Member States and on demand-supply balancing and network operations in relevant Member States, \u2014 assessing the impact, for the area of analysis as defined in Annex V.10, in terms of energy system-wide generation and transmission costs and evolution and convergence of market prices provided by a project under different planning scenarios, notably taking into account the variations induced on the merit order. (b) Transmission of renewable energy generation to major consumption centres and storage sites shall be measured in line with the analysis made in the latest available 10-year network development plan in electricity, notably by: \u2014 for electricity transmission, by estimating the amount of generation capacity from renewable energy sources (by technology, in megawatts), which is connected and transmitted due to the project, compared to the amount of planned total generation capacity from these types of renewable energy sources in the concerned Member State in 2020 according to the national renewable energy action plans as defined in Article 4 of Directive 2009/28/EC, \u2014 for electricity storage, by comparing new capacity provided by the project with total existing capacity for the same storage technology in the area of analysis as defined in Annex V.10. (c) Security of supply, interoperability and secure system operation shall be measured in line with the analysis made in the latest available 10-year network development plan in electricity, notably by assessing the impact of the project on the loss of load expectation for the area of analysis as defined in Annex V.10 in terms of generation and transmission adequacy for a set of characteristic load periods, taking into account expected changes in climate-related extreme weather events and their impact on infrastructure resilience. Where applicable, the impact of the project on independent and reliable control of system operation and services shall be measured. (3) Concerning projects falling under the categories set out in Annex II.2, the criteria listed in Article 4 shall be evaluated as follows: (a) Market integration and interoperability shall be measured by calculating the additional value of the project to the integration of market areas and price convergence, to the overall flexibility of the system, including the capacity level offered for reverse flows under various scenarios. (b) Competition shall be measured on the basis of diversification, including the facilitation of access to indigenous sources of supply, taking into account, successively: diversification of sources; diversification of counterparts; diversification of routes; the impact of new capacity on the Herfindahl-Hirschmann index (HHI)calculated at capacity level for the area of analysis as defined in Annex V.10. (c) Security of gas supply shall be measured by calculating the additional value of the project to the short and long-term resilience of the Union\u2019s gas system and to enhancing the remaining flexibility of the system to cope with supply disruptions to Member States under various scenarios as well as the additional capacity provided by the project measured in relation to the infrastructure standard (N-1 rule) at regional level in accordance with Article 6(3) of Regulation (EU) No 994/2010. (d) Sustainability shall be measured as the contribution of a project to reduce emissions, to support the back-up of renewable electricity generation or power-to-gas and biogas transportation, taking into account expected changes in climatic conditions. (4) Concerning projects falling under the category set out in Annex II.1(e), each function listed in Article 4 shall be evaluated against the following criteria: (a) Level of sustainability: This criterion shall be measured by assessing the reduction of greenhouse gas emissions, and the environmental impact of electricity grid infrastructure. (b) Capacity of transmission and distribution grids to connect and bring electricity from and to users: This criterion shall be measured by estimating the installed capacity of distributed energy resources in distribution networks, the allowable maximum injection of electricity without congestion risks in transmission networks, and the energy not withdrawn from renewable sources due to congestion or security risks. (c) Network connectivity and access to all categories of network users: This criterion shall be measured by assessing the methods adopted to calculate charges and tariffs, as well as their structure, for generators, consumers and those that do both, and the operational flexibility provided for dynamic balancing of electricity in the network. (d) Security and quality of supply: This criterion shall be measured by assessing the ratio of reliably available generation capacity and peak demand, the share of electricity generated from renewable sources, the stability of the electricity system, the duration and frequency of interruptions per customer, including climate related disruptions, and the voltage quality performance. (e) Efficiency and service quality in electricity supply and grid operation: This criterion shall be measured by assessing the level of losses in transmission and in distribution networks, the ratio between minimum and maximum electricity demand within a defined time period, the demand side participation in electricity markets and in energy efficiency measures, the percentage utilisation (i.e. average loading) of electricity network components, the availability of network components (related to planned and unplanned maintenance) and its impact on network performances, and the actual availability of network capacity with respect to its standard value. (f) Contribution to cross-border electricity markets by load-flow control to alleviate loop-flows and increase interconnection capacities: This criterion shall be estimated by assessing the ratio between interconnection capacity of a Member State and its electricity demand, the exploitation of interconnection capacities, and the congestion rents across interconnections. (5) Concerning oil transport projects falling under the categories set out in Annex II.3, the criteria listed in Article 4 shall be evaluated as follows: (a) Security of oil supply shall be measured by assessing the additional value of the new capacity offered by a project for the short and long-term resilience of the system and the remaining flexibility of the system to cope with supply disruptions under various scenarios. (b) Interoperability shall be measured by assessing to what extent the project improves the operation of the oil network, in particular by providing the possibility of reverse flows. (c) Efficient and sustainable use of resources shall be measured by assessing the extent to which the project makes use of already existing infrastructure and contributes to minimising environmental and climate change burden and risks. (1) OJ L 295, 12.11.2010, p. 1. ANNEX V ENERGY SYSTEM-WIDE COST-BENEFIT ANALYSIS The methodology for a harmonised energy system-wide cost-benefit analysis for projects of common interest shall satisfy the following principles laid down in this Annex. (1) The methodology shall be based on a common input data set representing the Union\u2019s electricity and gas systems in the years n+5, n+10, n+15, and n+20, where n is the year in which the analysis is performed. This data set shall comprise at least: (a) in electricity: scenarios for demand, generation capacities by fuel type (biomass, geothermal, hydro, gas, nuclear, oil, solid fuels, wind, solar photovoltaic, concentrated solar, other renewable technologies) and their geographical location, fuel prices (including biomass, coal, gas and oil), carbon dioxide prices, the composition of the transmission and, if relevant, the distribution network, and its evolution, taking into account all new significant generation (including capacity equipped for capturing carbon dioxide), storage and transmission projects for which a final investment decision has been taken and that are due to be commissioned by the end of year n+5; (b) in gas: scenarios for demand, imports, fuel prices (including coal, gas and oil), carbon dioxide prices, the composition of the transmission network and its evolution, taking into account all new projects for which a final investment decision has been taken and that are due to be commissioned by the end of year n+5. (2) The data set shall reflect Union and national law in force at the date of analysis. The data sets used for electricity and gas respectively shall be compatible, notably with regard to assumptions on prices and volumes in each market. The data set shall be elaborated after formally consulting Member States and the organisations representing all relevant stakeholders. The Commission and the Agency shall ensure access to the required commercial data from third parties when applicable. (3) The methodology shall give guidance for the development and use of network and market modelling necessary for the cost- benefit analysis. (4) The cost-benefit analysis shall be based on a harmonised evaluation of costs and benefits for the different categories of projects analysed and cover at least the period of time referred to in point (1). (5) The cost-benefit analysis shall at least take into account the following costs: capital expenditure, operational and maintenance expenditure over the technical lifecycle of the project and decommissioning and waste management costs, where relevant. The methodology shall give guidance on discount rates to be used for the calculations. (6) For electricity transmission and storage, the cost-benefit analysis shall at least take into account the impact and compensations resulting from the application of Article 13 of Regulation (EC) No 714/2009, the impacts on the indicators defined in Annex IV, and the following impacts: (a) greenhouse gas emissions and transmission losses over the technical lifecycle of the project; (b) future costs for new generation and transmission investment over the technical lifecycle of the project; (c) operational flexibility, including optimisation of regulating power and ancillary services; (d) system resilience, including disaster and climate resilience, and system security, notably for European critical infrastructures as defined in Directive 2008/114/EC. (7) For gas, the cost-benefit analysis shall at least take into account the results of market testing the impacts on the indicators defined in Annex IV and the following impacts: (a) disaster and climate resilience, and system security, notably for European critical infrastructures as defined in Directive 2008/114/EC; (b) congestion in the gas network. (8) For smart grids, the cost-benefit analysis shall take into account the impacts on the indicators defined in Annex IV. (9) The detailed method used to take into account the indicators referred to in points 6 to 8 shall be elaborated after formally consulting Member States and the organisations representing all relevant stakeholders. (10) The methodology shall define the analysis to be carried out, based on the relevant input data set, by determining the impacts with and without each project. The area for the analysis of an individual project shall cover all Member States and third countries, on whose territory the project shall be built, all directly neighbouring Member States and all other Member States significantly impacted by the project. (11) The analysis shall identify the Member States on which the project has net positive impacts (beneficiaries) and those Member States on which the project has a net negative impact (cost bearers). Each cost-benefit analysis shall include sensitivity analyses concerning the input data set, the commissioning date of different projects in the same area of analysis and other relevant parameters. (12) Transmission, storage system and compressed and liquefied natural gas terminal operators and distribution system operators shall exchange the information necessary for the elaboration of the methodology, including the relevant network and market modelling. Any transmission or distribution system operator collecting information on behalf of other transmission or distribution system operators shall give back to the participating transmission and distribution system operators the results of the collection of data. (13) For the common electricity and gas market and network model set out in paragraph 8 of Article 11, the input data set referred to in point (1) shall cover the years n+10, n+20 and n+30 and the model shall allow for a full assessment of economic, social and environmental impacts, notably including external costs such as those related to greenhouse gas and conventional air pollutant emissions or security of supply. ANNEX VI GUIDELINES FOR TRANSPARENCY AND PUBLIC PARTICIPATION (1) The manual of procedures referred to in Article 9(1) shall at least specify: (a) the relevant law upon which decisions and opinions are based for the different types of relevant projects of common interest, including environmental law; (b) the relevant decisions and opinions to be obtained; (c) the names and contact details of the Competent Authority, other authorities and major stakeholders concerned; (d) the work flow, outlining each stage in the process, including an indicative time frame and a concise overview of the decision-making process; (e) information about the scope, structure and level of detail of documents to be submitted with the application for decisions, including a checklist; (f) the stages and means for the general public to participate in the process. (2) The detailed schedule referred to in Article 10(4)(b) shall specify as a minimum the following: (a) the decisions and opinions to be obtained; (b) the authorities, stakeholders, and the public likely to be concerned; (c) the individual stages of the procedure and their duration; (d) major milestones to be accomplished and their deadlines in view of the comprehensive decision to be taken; (e) the resources planned by the authorities and possible additional resource needs. (3) To increase public participation in the permit granting process and ensure in advance information and dialogue with the public, the following principles shall be applied: (a) The stakeholders affected by a project of common interest, including relevant national, regional and local authorities, landowners and citizens living in the vicinity of the project, the general public and their associations, organisations or groups, shall be extensively informed and consulted at an early stage, when potential concerns by the public can still be taken into account and in an open and transparent manner. Where relevant, the competent authority shall actively support the activities undertaken by the project promoter. (b) Competent authorities shall ensure that public consultation procedures for projects of common interest are grouped together where possible. Each public consultation shall cover all subject matters relevant to the particular stage of the procedure, and one subject matter relevant to the particular stage of the procedure shall not be addressed in more than one public consultation; however, one public consultation may take place in more than one geographical location. The subject matters addressed by a public consultation shall be clearly indicated in the notification of the public consultation. (c) Comments and objections shall be admissible from the beginning of the public consultation until the expiry of the deadline only. (4) The concept for public participation shall at least include information about: (a) the stakeholders concerned and addressed; (b) the measures envisaged, including proposed general locations and dates of dedicated meetings; (c) the timeline; (d) the human resources allocated to the respective tasks. (5) In the context of the public consultation to be carried out before submission of the application file, the relevant parties shall at least: (a) publish an information leaflet of no more than 15 pages, giving, in a clear and concise manner, an overview of the purpose and preliminary timetable of the project, the national grid development plan, alternative routes considered, expected impacts, including of cross-border nature, and possible mitigation measures, which shall be published prior to the start of the consultation; The information leaflet shall furthermore list the web addresses of the transparency platform referred to in Article 18 and of the manual of procedures referred to in point (1); (b) inform all stakeholders affected about the project through the website referred to in Article 9(7) and other appropriate information means; (c) invite in written form relevant affected stakeholders to dedicated meetings, during which concerns shall be discussed. (6) The project website shall make available as a minimum the following: (a) the information leaflet referred to in point (5); (b) a non-technical and regularly updated summary of no more than 50 pages reflecting the current status of the project and clearly indicating, in case of updates, changes to previous versions; (c) the project and public consultation planning, clearly indicating dates and locations for public consultations and hearings and the envisaged subject matters relevant for those hearings; (d) contact details in view of obtaining the full set of application documents; (e) contact details in view of conveying comments and objections during public consultations. Statement by the European Commission as regards the eligibility of projects of common interest for EU financial assistance in the context of trans-European energy infrastructures (Chapter V of Regulation (EU) No 347/2013 of the European Parliament and of the Council (1)) The Commission underlines that it considers important that the support from EU and national sources extends to grants for works to enable the implementation of projects of common interest enhancing the diversification of energy supply sources, routes and counterparts. The Commission reserves the right to make proposals in this direction based on the experience gained from the monitoring of the implementation of projects of common interest in the context of the report foreseen in Article 17 of the Regulation on guidelines for trans-European energy infrastructures. (1) See page 39 of this Official Journal.", "summary": "Guidelines for trans-European energy infrastructure Guidelines for trans-European energy infrastructure This EU regulation lays down guidelines to develop priority corridors and areas of trans-European energy infrastructure in a timely fashion. SUMMARY In April 2013, the EU guidelines for the development of European energy infrastructure were approved. One of the priorities of the Europe 2020 strategy is sustainable growth to be achieved by promoting a more resource-efficient, more sustainable and more competitive economy. That strategy put energy infrastructure at the forefront of this effort by underlining the need to urgently upgrade Europe\u2019s networks, interconnecting them at the continental level, in particular to integrate renewable energy sources. The essential background to this is that EU Member States agreed in 2011 that: Europe\u2019s energy infrastructure needs to be modernised and expanded; networks across borders need to be interconnected; there is a need to provide for alternative supply or transit routes; there is a need for alternative sources of energy, including renewables; no EU country should remain isolated from the European gas and electricity networks after 2015 or see its energy security jeopardised by lack of the appropriate connections. The guidelines established 12 regional groups for trans-European energy infrastructure (TEN-E), which selected projects. In October 2013, the Commission adopted a list of 248 key energy infrastructure projects (projects of common interest), which will benefit from faster and more efficient permit granting procedures and improved regulatory treatment. The projects may also have access to financial support from the Connecting Europe Facility(CEF), under which almost EUR 6 billion has been allocated to TEN-E up to 2020. For a project to be included in the list, it has to: have significant benefits for at leasttwoEU Member States ; contribute to market integration and further competition; enhance security of supply; reduce CO2emissions. A new EU list will be established every 2 years. The guidelines state that projects of common interest should be implemented as quickly as possible and closely monitored and evaluated, while keeping the administrative burden for project promoters to a minimum. It adds that the Commission should nominate European coordinators for projects facing particular difficulties. ACT Regulation (EU) No 347/2013 of the European Parliament and of the Council on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 347/2013 - - OJ L 115 of 25.4.2013 last update 04.04.2014"}
{"article": "18.6.2013 EN Official Journal of the European Union L 165/1 REGULATION (EU) No 524/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 May 2013 on online dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Regulation on consumer ODR) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Article 169(1) and point (a) of Article 169(2) of the Treaty on the Functioning of the European Union (TFEU) provide that the Union is to contribute to the attainment of a high level of consumer protection through measures adopted pursuant to Article 114 TFEU. Article 38 of the Charter of Fundamental Rights of the European Union provides that Union policies are to ensure a high level of consumer protection. (2) In accordance with Article 26(2) TFEU, the internal market is to comprise an area without internal frontiers in which the free movement of goods and services is ensured. In order for consumers to have confidence in and benefit from the digital dimension of the internal market, it is necessary that they have access to simple, efficient, fast and low-cost ways of resolving disputes which arise from the sale of goods or the supply of services online. This is particularly important when consumers shop cross-border. (3) In its Communication of 13 April 2011 entitled \u2018Single Market Act \u2014 Twelve levers to boost growth and strengthen confidence \u2014 \u201cWorking together to create new growth\u201d \u2019, the Commission identified legislation on alternative dispute resolution (ADR) which includes an electronic commerce dimension as one of the twelve levers to boost growth and strengthen confidence in the Single Market. (4) Fragmentation of the internal market impedes efforts to boost competitiveness and growth. Furthermore, the uneven availability, quality and awareness of simple, efficient, fast and low-cost means of resolving disputes arising from the sale of goods or provision of services across the Union constitutes a barrier within the internal market which undermines consumers\u2019 and traders\u2019 confidence in shopping and selling across borders. (5) In its conclusions of 24-25 March and 23 October 2011, the European Council invited the European Parliament and the Council to adopt, by the end of 2012, a first set of priority measures to bring a new impetus to the Single Market. (6) The internal market is a reality for consumers in their daily lives, when they travel, make purchases and make payments. Consumers are key players in the internal market and should therefore be at its heart. The digital dimension of the internal market is becoming vital for both consumers and traders. Consumers increasingly make purchases online and an increasing number of traders sell online. Consumers and traders should feel confident in carrying out transactions online so it is essential to dismantle existing barriers and to boost consumer confidence. The availability of reliable and efficient online dispute resolution (ODR) could greatly help achieve this goal. (7) Being able to seek easy and low-cost dispute resolution can boost consumers\u2019 and traders\u2019 confidence in the digital Single Market. Consumers and traders, however, still face barriers to finding out-of-court solutions in particular to their disputes arising from cross-border online transactions. Thus, such disputes currently are often left unresolved. (8) ODR offers a simple, efficient, fast and low-cost out-of-court solution to disputes arising from online transactions. However, there is currently a lack of mechanisms which allow consumers and traders to resolve such disputes through electronic means; this leads to consumer detriment, acts as a barrier, in particular, to cross-border online transactions, and creates an uneven playing field for traders, and thus hampers the overall development of online commerce. (9) This Regulation should apply to the out-of-court resolution of disputes initiated by consumers resident in the Union against traders established in the Union which are covered by Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes (Directive on consumer ADR) (3). (10) In order to ensure that the ODR platform can also be used for ADR procedures which allow traders to submit complaints against consumers, this Regulation should also apply to the out-of-court resolution of disputes initiated by traders against consumers where the relevant ADR procedures are offered by ADR entities listed in accordance with Article 20(2) of Directive 2013/11/EU. The application of this Regulation to such disputes should not impose any obligation on Member States to ensure that the ADR entities offer such procedures. (11) Although in particular consumers and traders carrying out cross-border online transactions will benefit from the ODR platform, this Regulation should also apply to domestic online transactions in order to allow for a true level playing field in the area of online commerce. (12) This Regulation should be without prejudice to Directive 2008/52/EC of the European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters (4). (13) The definition of \u2018consumer\u2019 should cover natural persons who are acting outside their trade, business, craft or profession. However, if the contract is concluded for purposes partly within and partly outside the person\u2019s trade (dual purpose contracts) and the trade purpose is so limited as not to be predominant in the overall context of the supply, that person should also be considered as a consumer. (14) The definition of \u2018online sales or service contract\u2019 should cover a sales or service contract where the trader, or the trader\u2019s intermediary, has offered goods or services through a website or by other electronic means and the consumer has ordered those goods or services on that website or by other electronic means. This should also cover cases where the consumer has accessed the website or other information society service through a mobile electronic device such as a mobile telephone. (15) This Regulation should not apply to disputes between consumers and traders that arise from sales or service contracts concluded offline and to disputes between traders. (16) This Regulation should be considered in conjunction with Directive 2013/11/EU which requires Member States to ensure that all disputes between consumers resident and traders established in the Union which arise from the sale of goods or provisions of services can be submitted to an ADR entity. (17) Before submitting their complaint to an ADR entity through the ODR platform, consumers should be encouraged by Member States to contact the trader by any appropriate means, with the aim of resolving the dispute amicably. (18) This Regulation aims to create an ODR platform at Union level. The ODR platform should take the form of an interactive website offering a single point of entry to consumers and traders seeking to resolve disputes out-of-court which have arisen from online transactions. The ODR platform should provide general information regarding the out-of-court resolution of contractual disputes between traders and consumers arising from online sales and service contracts. It should allow consumers and traders to submit complaints by filling in an electronic complaint form available in all the official languages of the institutions of the Union and to attach relevant documents. It should transmit complaints to an ADR entity competent to deal with the dispute concerned. The ODR platform should offer, free of charge, an electronic case management tool which enables ADR entities to conduct the dispute resolution procedure with the parties through the ODR platform. ADR entities should not be obliged to use the case management tool. (19) The Commission should be responsible for the development, operation and maintenance of the ODR platform and provide all technical facilities necessary for the functioning of the platform. The ODR platform should offer an electronic translation function which enables the parties and the ADR entity to have the information which is exchanged through the ODR platform and is necessary for the resolution of the dispute translated, where appropriate. That function should be capable of dealing with all necessary translations and should be supported by human intervention, if necessary. The Commission should also provide, on the ODR platform, information for complainants about the possibility of requesting assistance from the ODR contact points. (20) The ODR platform should enable the secure interchange of data with ADR entities and respect the underlying principles of the European Interoperability Framework adopted pursuant to Decision 2004/387/EC of the European Parliament and of the Council of 21 April 2004 on interoperable delivery of pan-European eGovernment services to public administrations, businesses and citizens (IDABC) (5). (21) The ODR platform should be made accessible, in particular, through the \u2018Your Europe portal\u2019 established in accordance with Annex II to Decision 2004/387/EC, which provides access to pan-European, multilingual online information and interactive services to businesses and citizens in the Union. The ODR platform should be given prominence on the \u2018Your Europe portal\u2019. (22) An ODR platform at Union level should build on existing ADR entities in the Member States and respect the legal traditions of the Member States. ADR entities to which a complaint has been transmitted through the ODR platform should therefore apply their own procedural rules, including rules on cost. However, this Regulation intends to establish some common rules applicable to those procedures that will safeguard their effectiveness. This should include rules ensuring that such dispute resolution does not require the physical presence of the parties or their representatives before the ADR entity, unless its procedural rules provide for that possibility and the parties agree. (23) Ensuring that all ADR entities listed in accordance with Article 20(2) of Directive 2013/11/EU are registered with the ODR platform should allow for full coverage in online out-of-court resolution for disputes arising from online sales or service contracts. (24) This Regulation should not prevent the functioning of any existing dispute resolution entity operating online or of any ODR mechanism within the Union. It should not prevent dispute resolution entities or mechanisms from dealing with online disputes which have been submitted directly to them. (25) ODR contact points hosting at least two ODR advisors should be designated in each Member State. The ODR contact points should support the parties involved in a dispute submitted through the ODR platform without being obliged to translate documents relating to that dispute. Member States should have the possibility to confer the responsibility for the ODR contact points on their centres of the European Consumer Centres Network. Member States should make use of that possibility in order to allow ODR contact points to fully benefit from the experience of the centres of the European Consumer Centres Network in facilitating the settlement of disputes between consumers and traders. The Commission should establish a network of ODR contact points to facilitate their cooperation and work and provide, in cooperation with Member States, appropriate training for ODR contact points. (26) The right to an effective remedy and the right to a fair trial are fundamental rights laid down in Article 47 of the Charter of Fundamental Rights of the European Union. ODR is not intended to and cannot be designed to replace court procedures, nor should it deprive consumers or traders of their rights to seek redress before the courts. This Regulation should not, therefore, prevent parties from exercising their right of access to the judicial system. (27) The processing of information under this Regulation should be subject to strict guarantees of confidentiality and should comply with the rules on the protection of personal data laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (6) and in Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (7). Those rules should apply to the processing of personal data carried out under this Regulation by the various actors of the ODR platform, whether they act alone or jointly with other such actors. (28) Data subjects should be informed about, and give their consent to, the processing of their personal data in the ODR platform, and should be informed about their rights with regard to that processing, by means of a comprehensive privacy notice to be made publicly available by the Commission and explaining, in clear and simple language, the processing operations performed under the responsibility of the various actors of the platform, in accordance with Articles 11 and 12 of Regulation (EC) No 45/2001 and with national legislation adopted pursuant to Articles 10 and 11 of Directive 95/46/EC. (29) This Regulation should be without prejudice to provisions on confidentiality in national legislation relating to ADR. (30) In order to ensure broad consumer awareness of the existence of the ODR platform, traders established within the Union engaging in online sales or service contracts should provide, on their websites, an electronic link to the ODR platform. Traders should also provide their email address so that consumers have a first point of contact. A significant proportion of online sales and service contracts are concluded using online marketplaces, which bring together or facilitate online transactions between consumers and traders. Online marketplaces are online platforms which allow traders to make their products and services available to consumers. Such online marketplaces should therefore have the same obligation to provide an electronic link to the ODR platform. This obligation should be without prejudice to Article 13 of Directive 2013/11/EU concerning the requirement that traders inform consumers about the ADR procedures by which those traders are covered and about whether or not they commit to use ADR procedures to resolve disputes with consumers. Furthermore, that obligation should be without prejudice to point (t) of Article 6(1) and to Article 8 of Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights (8). Point (t) of Article 6(1) of Directive 2011/83/EU stipulates for consumer contracts concluded at a distance or off premises, that the trader is to inform the consumer about the possibility of having recourse to an out-of-court complaint and redress mechanism to which the trader is subject, and the methods for having access to it, before the consumer is bound by the contract. For the same consumer awareness reasons, Member States should encourage consumer associations and business associations to provide an electronic link to the website of the ODR platform. (31) In order to take into account the criteria by which the ADR entities define their respective scopes of application the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to adapt the information which a complainant is to provide in the electronic complaint form made available on the ODR platform. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (32) In order to ensure uniform conditions for the implementation of this Regulation implementing powers should be conferred on the Commission in respect of the functioning of the ODR platform, the modalities for the submission of a complaint and cooperation within the network of ODR contact points. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (9). The advisory procedure should be used for the adoption of implementing acts relating to the electronic complaint form given its purely technical nature. The examination procedure should be used for the adoption of the rules concerning the modalities of cooperation between the ODR advisors of the network of ODR contact points. (33) In the application of this Regulation, the Commission should consult, where appropriate, the European Data Protection Supervisor. (34) Since the objective of this Regulation, namely to set up a European ODR platform for online disputes governed by common rules, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (35) This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and specifically Articles 7, 8, 38 and 47 thereof. (36) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 12 January 2012 (10), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter The purpose of this Regulation is, through the achievement of a high level of consumer protection, to contribute to the proper functioning of the internal market, and in particular of its digital dimension by providing a European ODR platform (\u2018ODR platform\u2019) facilitating the independent, impartial, transparent, effective, fast and fair out-of-court resolution of disputes between consumers and traders online. Article 2 Scope 1. This Regulation shall apply to the out-of-court resolution of disputes concerning contractual obligations stemming from online sales or service contracts between a consumer resident in the Union and a trader established in the Union through the intervention of an ADR entity listed in accordance with Article 20(2) of Directive 2013/11/EU and which involves the use of the ODR platform. 2. This Regulation shall apply to the out-of-court resolution of disputes referred to in paragraph 1, which are initiated by a trader against a consumer, in so far as the legislation of the Member State where the consumer is habitually resident allows for such disputes to be resolved through the intervention of an ADR entity. 3. Member States shall inform the Commission about whether or not their legislation allows for disputes referred to in paragraph 1, which are initiated by a trader against a consumer, to be resolved through the intervention of an ADR entity. Competent authorities shall, when they notify the list referred to in Article 20(2) of Directive 2013/11/EU, inform the Commission about which ADR entities deal with such disputes. 4. The application of this Regulation to disputes referred to in paragraph 1, which are initiated by a trader against a consumer, shall not impose any obligation on Member States to ensure that ADR entities offer procedures for the out-of-court resolution of such disputes. Article 3 Relationship with other Union legal acts This Regulation shall be without prejudice to Directive 2008/52/EC. Article 4 Definitions 1. For the purposes of this Regulation: (a) \u2018consumer\u2019 means a consumer as defined in point (a) of Article 4(1) of Directive 2013/11/EU; (b) \u2018trader\u2019 means a trader as defined in point (b) of Article 4(1) of Directive 2013/11/EU; (c) \u2018sales contract\u2019 means a sales contract as defined in point (c) of Article 4(1) of Directive 2013/11/EU; (d) \u2018service contract\u2019 means a service contract as defined in point (d) of Article 4(1) of Directive 2013/11/EU; (e) \u2018online sales or service contract\u2019 means a sales or service contract where the trader, or the trader\u2019s intermediary, has offered goods or services on a website or by other electronic means and the consumer has ordered such goods or services on that website or by other electronic means; (f) \u2018online marketplace\u2019 means a service provider, as defined in point (b) of Article 2 of Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (\u2018Directive on electronic commerce\u2019) (11), which allows consumers and traders to conclude online sales and service contracts on the online marketplace\u2019s website; (g) \u2018electronic means\u2019 means electronic equipment for the processing (including digital compression) and storage of data which is entirely transmitted, conveyed and received by wire, by radio, by optical means or by other electromagnetic means; (h) \u2018alternative dispute resolution procedure\u2019 (\u2018ADR procedure\u2019) means a procedure for the out-of-court resolution of disputes as referred to in Article 2 of this Regulation; (i) \u2018alternative dispute resolution entity\u2019 (\u2018ADR entity\u2019) means an ADR entity as defined in point (h) of Article 4(1) of Directive 2013/11/EU; (j) \u2018complainant party\u2019 means the consumer who or the trader that has submitted a complaint through the ODR platform; (k) \u2018respondent party\u2019 means the consumer against whom or the trader against whom a complaint has been submitted through the ODR platform; (l) \u2018competent authority\u2019 means a public authority as defined in point (i) of Article 4(1) of Directive 2013/11/EU; (m) \u2018personal data\u2019 means any information relating to an identified or identifiable natural person (\u2018data subject\u2019); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to that person\u2019s physical, physiological, mental, economic, cultural or social identity. 2. The place of establishment of the trader and of the ADR entity shall be determined in accordance with Article 4(2) and (3) of Directive 2013/11/EU, respectively. CHAPTER II ODR PLATFORM Article 5 Establishment of the ODR platform 1. The Commission shall develop the ODR platform (and be responsible for its operation, including all the translation functions necessary for the purpose of this Regulation, its maintenance, funding and data security. The ODR platform shall be user-friendly. The development, operation and maintenance of the ODR platform shall ensure that the privacy of its users is respected from the design stage (\u2018privacy by design\u2019) and that the ODR platform is accessible and usable by all, including vulnerable users (\u2018design for all\u2019), as far as possible. 2. The ODR platform shall be a single point of entry for consumers and traders seeking the out-of-court resolution of disputes covered by this Regulation. It shall be an interactive website which can be accessed electronically and free of charge in all the official languages of the institutions of the Union. 3. The Commission shall make the ODR platform accessible, as appropriate, through its websites which provide information to citizens and businesses in the Union and, in particular, through the \u2018Your Europe portal\u2019 established in accordance with Decision 2004/387/EC. 4. The ODR platform shall have the following functions: (a) to provide an electronic complaint form which can be filled in by the complainant party in accordance with Article 8; (b) to inform the respondent party about the complaint; (c) to identify the competent ADR entity or entities and transmit the complaint to the ADR entity, which the parties have agreed to use, in accordance with Article 9; (d) to offer an electronic case management tool free of charge, which enables the parties and the ADR entity to conduct the dispute resolution procedure online through the ODR platform; (e) to provide the parties and ADR entity with the translation of information which is necessary for the resolution of the dispute and is exchanged through the ODR platform; (f) to provide an electronic form by means of which ADR entities shall transmit the information referred to in point (c) of Article 10; (g) to provide a feedback system which allows the parties to express their views on the functioning of the ODR platform and on the ADR entity which has handled their dispute; (h) to make publicly available the following: (i) general information on ADR as a means of out-of-court dispute resolution; (ii) information on ADR entities listed in accordance with Article 20(2) of Directive 2013/11/EU which are competent to deal with disputes covered by this Regulation; (iii) an online guide about how to submit complaints through the ODR platform; (iv) information, including contact details, on ODR contact points designated by the Member States in accordance with Article 7(1) of this Regulation; (v) statistical data on the outcome of the disputes which were transmitted to ADR entities through the ODR platform. 5. The Commission shall ensure that the information referred to in point (h) of paragraph 4 is accurate, up to date and provided in a clear, understandable and easily accessible way. 6. ADR entities listed in accordance with Article 20(2) of Directive 2013/11/EU which are competent to deal with disputes covered by this Regulation shall be registered electronically with the ODR platform. 7. The Commission shall adopt measures concerning the modalities for the exercise of the functions provided for in paragraph 4 of this Article through implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(3) of this Regulation. Article 6 Testing of the ODR platform 1. The Commission shall, by 9 January 2015 test the technical functionality and user-friendliness of the ODR platform and of the complaint form, including with regard to translation. The testing shall be carried out and evaluated in cooperation with experts in ODR from the Member States and consumer and trader representatives. The Commission shall submit a report to the European Parliament and the Council of the result of the testing and take the appropriate measures to address potential problems in order to ensure the effective functioning of the ODR platform. 2. In the report referred to in paragraph 1 of this Article, the Commission shall also describe the technical and organisational measures it intends to take to ensure that the ODR platform meets the privacy requirements set out in Regulation (EC) No 45/2001. Article 7 Network of ODR contact points 1. Each Member State shall designate one ODR contact point and communicate its name and contact details to the Commission. The Member States may confer responsibility for the ODR contact points on their centres of the European Consumer Centres Network, on consumer associations or on any other body. Each ODR contact point shall host at least two ODR advisors. 2. The ODR contact points shall provide support to the resolution of disputes relating to complaints submitted through the ODR platform by fulfilling the following functions: (a) if requested, facilitating communication between the parties and the competent ADR entity, which may include, in particular: (i) assisting with the submission of the complaint and, where appropriate, relevant documentation; (ii) providing the parties and ADR entities with general information on consumer rights in relation to sales and service contracts which apply in the Member State of the ODR contact point which hosts the ODR advisor concerned; (iii) providing information on the functioning of the ODR platform; (iv) providing the parties with explanations on the procedural rules applied by the ADR entities identified; (v) informing the complainant party of other means of redress when a dispute cannot be resolved through the ODR platform; (b) submitting, based on the practical experience gained from the performance of their functions, every two years an activity report to the Commission and to the Member States. 3. The ODR contact point shall not be obliged to perform the functions listed in paragraph 2 in the case of disputes where the parties are habitually resident in the same Member State. 4. Notwithstanding paragraph 3, the Member States may decide, taking into account national circumstances, that the ODR contact point performs one or more functions listed in paragraph 2 in the case of disputes where the parties are habitually resident in the same Member State. 5. The Commission shall establish a network of contact points (\u2018ODR contact points network\u2019) which shall enable cooperation between contact points and contribute to the performance of the functions listed in paragraph 2. 6. The Commission shall at least twice a year convene a meeting of members of the ODR contact points network in order to permit an exchange of best practice, and a discussion of any recurring problems encountered in the operation of the ODR platform. 7. The Commission shall adopt the rules concerning the modalities of the cooperation between the ODR contact points through implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(3). Article 8 Submission of a complaint 1. In order to submit a complaint to the ODR platform the complainant party shall fill in the electronic complaint form. The complaint form shall be user-friendly and easily accessible on the ODR platform. 2. The information to be submitted by the complainant party shall be sufficient to determine the competent ADR entity. That information is listed in the Annex to this Regulation. The complainant party may attach documents in support of the complaint. 3. In order to take into account the criteria by which the ADR entities, that are listed in accordance with Article 20(2) of Directive 2013/11/EU and that deal with disputes covered by this Regulation, define their respective scopes of application, the Commission shall be empowered to adopt delegated acts in accordance with Article 17 of this Regulation to adapt the information listed in the Annex to this Regulation. 4. The Commission shall lay down the rules concerning the modalities for the electronic complaint form by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 16(2). 5. Only data which are accurate, relevant and not excessive in relation to the purposes for which they are collected shall be processed through the electronic complaint form and its attachments. Article 9 Processing and transmission of a complaint 1. A complaint submitted to the ODR platform shall be processed if all the necessary sections of the electronic complaint form have been completed. 2. If the complaint form has not been fully completed, the complainant party shall be informed that the complaint cannot be processed further, unless the missing information is provided. 3. Upon receipt of a fully completed complaint form, the ODR platform shall, in an easily understandable way and without delay, transmit to the respondent party, in one of the official languages of the institutions of the Union chosen by that party, the complaint together with the following data: (a) information that the parties have to agree on an ADR entity in order for the complaint to be transmitted to it, and that, if no agreement is reached by the parties or no competent ADR entity is identified, the complaint will not be processed further; (b) information about the ADR entity or entities which are competent to deal with the complaint, if any are referred to in the electronic complaint form or are identified by the ODR platform on the basis of the information provided in that form; (c) in the event that the respondent party is a trader, an invitation to state within 10 calendar days: \u2014 whether the trader commits to, or is obliged to use, a specific ADR entity to resolve disputes with consumers, and \u2014 unless the trader is obliged to use a specific ADR entity, whether the trader is willing to use any ADR entity or entities from those referred to in point (b); (d) in the event that the respondent party is a consumer and the trader is obliged to use a specific ADR entity, an invitation to agree within 10 calendar days on that ADR entity or, in the event that the trader is not obliged to use a specific ADR entity, an invitation to select one or more ADR entities from those referred to in point (b); (e) the name and contact details of the ODR contact point in the Member State where the respondent party is established or resident, as well as a brief description of the functions referred to in point (a) of Article 7(2). 4. Upon receipt from the respondent party of the information referred to in point (c) or point (d) of paragraph 3, the ODR platform shall in an easily understandable way and without delay communicate to the complainant party, in one of the official languages of the institutions of the Union chosen by that party, the following information: (a) the information referred to in point (a) of paragraph 3; (b) in the event that the complainant party is a consumer, the information about the ADR entity or entities stated by the trader in accordance with point (c) of paragraph 3 and an invitation to agree within 10 calendar days on an ADR entity; (c) in the event that the complainant party is a trader and the trader is not obliged to use a specific ADR entity, the information about the ADR entity or entities stated by the consumer in accordance with point (d) of paragraph 3 and an invitation to agree within 10 calendar days on an ADR entity; (d) the name and contact details of the ODR contact point in the Member State where the complainant party is established or resident, as well as a brief description of the functions referred to in point (a) of Article 7(2). 5. The information referred to in point (b) of paragraph 3 and in points (b) and (c) of paragraph 4 shall include a description of the following characteristics of each ADR entity: (a) the name, contact details and website address of the ADR entity; (b) the fees for the ADR procedure, if applicable; (c) the language or languages in which the ADR procedure can be conducted; (d) the average length of the ADR procedure; (e) the binding or non-binding nature of the outcome of the ADR procedure; (f) the grounds on which the ADR entity may refuse to deal with a given dispute in accordance with Article 5(4) of Directive 2013/11/EU. 6. The ODR platform shall automatically and without delay transmit the complaint to the ADR entity that the parties have agreed to use in accordance with paragraphs 3 and 4. 7. The ADR entity to which the complaint has been transmitted shall without delay inform the parties about whether it agrees or refuses to deal with the dispute in accordance with Article 5(4) of Directive 2013/11/EU. The ADR entity which has agreed to deal with the dispute shall also inform the parties of its procedural rules and, if applicable, of the costs of the dispute resolution procedure concerned. 8. Where the parties fail to agree within 30 calendar days after submission of the complaint form on an ADR entity, or the ADR entity refuses to deal with the dispute, the complaint shall not be processed further. The complainant party shall be informed of the possibility of contacting an ODR advisor for general information on other means of redress. Article 10 Resolution of the dispute An ADR entity which has agreed to deal with a dispute in accordance with Article 9 of this Regulation shall: (a) conclude the ADR procedure within the deadline referred to in point (e) of Article 8 of Directive 2013/11/EU; (b) not require the physical presence of the parties or their representatives, unless its procedural rules provide for that possibility and the parties agree; (c) without delay transmit the following information to the ODR platform: (i) the date of receipt of the complaint file; (ii) the subject-matter of the dispute; (iii) the date of conclusion of the ADR procedure; (iv) the result of the ADR procedure; (d) not be required to conduct the ADR procedure through the ODR platform. Article 11 Database The Commission shall take the necessary measures to establish and maintain an electronic database in which it shall store the information processed in accordance with Article 5(4) and point (c) of Article 10 taking due account of Article 13(2). Article 12 Processing of personal data 1. Access to information, including personal data, related to a dispute and stored in the database referred to in Article 11 shall be granted, for the purposes referred to in Article 10, only to the ADR entity to which the dispute was transmitted in accordance with Article 9. Access to the same information shall be granted also to ODR contact points, in so far as it is necessary, for the purposes referred to in Article 7(2) and (4). 2. The Commission shall have access to information processed in accordance with Article 10 for the purposes of monitoring the use and functioning of the ODR platform and drawing up the reports referred to in Article 21. It shall process personal data of the users of the ODR platform in so far as it is necessary for the operation and maintenance of the ODR platform, including for the purposes of monitoring the use of the ODR platform by ADR entities and ODR contact points. 3. Personal data related to a dispute shall be kept in the database referred to in paragraph 1 of this Article only for the time necessary to achieve the purposes for which they were collected and to ensure that data subjects are able to access their personal data in order to exercise their rights, and shall be automatically deleted, at the latest, six months after the date of conclusion of the dispute which has been transmitted to the ODR platform in accordance with point (iii) of point (c) of Article 10. That retention period shall also apply to personal data kept in national files by the ADR entity or the ODR contact point which dealt with the dispute concerned, except if the procedural rules applied by the ADR entity or any specific provisions of national law provide for a longer retention period. 4. Each ODR advisor shall be regarded as a controller with respect to its data processing activities under this Regulation, in accordance with point (d) of Article 2 of Directive 95/46/EC, and shall ensure that those activities comply with national legislation adopted pursuant to Directive 95/46/EC in the Member State of the ODR contact point hosting the ODR advisor. 5. Each ADR entity shall be regarded as a controller with respect to its data processing activities under this Regulation, in accordance with point (d) of Article 2 of Directive 95/46/EC, and shall ensure that those activities comply with national legislation adopted pursuant to Directive 95/46/EC in the Member State where the ADR entity is established. 6. In relation to its responsibilities under this Regulation and the processing of personal data involved therein, the Commission shall be regarded as a controller in accordance with point (d) of Article 2 of Regulation (EC) No 45/2001. Article 13 Data confidentiality and security 1. ODR contact points shall be subject to rules of professional secrecy or other equivalent duties of confidentiality laid down in the legislation of the Member State concerned. 2. The Commission shall take the appropriate technical and organisational measures to ensure the security of information processed under this Regulation, including appropriate data access control, a security plan and a security incident management, in accordance with Article 22 of Regulation (EC) No 45/2001. Article 14 Consumer information 1. Traders established within the Union engaging in online sales or service contracts, and online marketplaces established within the Union, shall provide on their websites an electronic link to the ODR platform. That link shall be easily accessible for consumers. Traders established within the Union engaging in online sales or service contracts shall also state their e-mail addresses. 2. Traders established within the Union engaging in online sales or service contracts, which are committed or obliged to use one or more ADR entities to resolve disputes with consumers, shall inform consumers about the existence of the ODR platform and the possibility of using the ODR platform for resolving their disputes. They shall provide an electronic link to the ODR platform on their websites and, if the offer is made by e-mail, in that e-mail. The information shall also be provided, where applicable, in the general terms and conditions applicable to online sales and service contracts. 3. Paragraphs 1 and 2 of this Article shall be without prejudice to Article 13 of Directive 2013/11/EU and the provisions on consumer information on out-of-court redress procedures contained in other Union legal acts, which shall apply in addition to this Article. 4. The list of ADR entities referred to in Article 20(4) of Directive 2013/11/EU and its updates shall be published in the ODR platform. 5. Member States shall ensure that ADR entities, the centres of the European Consumer Centres Network, the competent authorities defined in Article 18(1) of Directive 2013/11/EU, and, where appropriate, the bodies designated in accordance with Article 14(2) of Directive 2013/11/EU provide an electronic link to the ODR platform. 6. Member States shall encourage consumer associations and business associations to provide an electronic link to the ODR platform. 7. When traders are obliged to provide information in accordance with paragraphs 1 and 2 and with the provisions referred to in paragraph 3, they shall, where possible, provide that information together. Article 15 Role of the competent authorities The competent authority of each Member State shall assess whether the ADR entities established in that Member State comply with the obligations set out in this Regulation. CHAPTER III FINAL PROVISIONS Article 16 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where the opinion of the committee under paragraphs 2 and 3 is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so request. Article 17 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 8(3) shall be conferred for an indeterminate period of time from 8 July 2013. 3. The delegation of power referred to in Article 8(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 8(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 18 Penalties Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Article 19 Amendment to Regulation (EC) No 2006/2004 In the Annex to Regulation (EC) No 2006/2004 of the European Parliament and of the Council (12) the following point is added: \u201821. Regulation (EU) No 524/2013 of the European Parliament and of the Council of 21 May 2013 on online dispute resolution for consumer disputes (Regulation on consumer ODR) (OJ L 165, 18.6.2013, p. 1): Article 14.\u2019 Article 20 Amendment to Directive 2009/22/EC Directive 2009/22/EC of the European Parliament and of the Council (13) is amended as follows: (1) in Article 1(1) and (2) and point (b) of Article 6(2), the words \u2018Directives listed in Annex I\u2019 are replaced with the words \u2018Union acts listed in Annex I\u2019; (2) in the heading of Annex I, the words \u2018LIST OF DIRECTIVES\u2019 are replaced by the words \u2018LIST OF UNION ACTS\u2019; (3) in Annex I, the following point is added: \u201815. Regulation (EU) No 524/2013 of the European Parliament and of the Council of 21 May 2013 on online dispute resolution for consumer disputes (Regulation on consumer ODR) (OJ L 165, 18.6.2013, p. 1): Article 14.\u2019 Article 21 Reports 1. The Commission shall report to the European Parliament and the Council on the functioning of the ODR platform on a yearly basis and for the first time one year after the ODR platform has become operational. 2. By 9 July 2018 and every three years thereafter the Commission shall submit to the European Parliament and the Council a report on the application of this Regulation, including in particular on the user-friendliness of the complaint form and the possible need for adaptation of the information listed in the Annex to this Regulation. That report shall be accompanied, if necessary, by proposals for adaptations to this Regulation. 3. Where the reports referred to in paragraphs 1 and 2 are to be submitted in the same year, only one joint report shall be submitted. Article 22 Entry into force 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. This Regulation shall apply from 9 January 2016, except for the following provisions: \u2014 Article 2(3) and Article 7(1) and (5), which shall apply from 9 July 2015, \u2014 Article 5(1) and (7), Article 6, Article 7(7), Article 8(3) and (4) and Articles 11, 16 and 17, which shall apply from 8 July 2013. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 21 May 2013. For the European Parliament The President M. SCHULZ For the Council The President L. CREIGHTON (1) OJ C 181, 21.6.2012, p. 99. (2) Position of the European Parliament of 12 March 2013 (not yet published in the Official Journal) and Decision of the Council of 22 April 2013. (3) See page 63 of this Official Journal. (4) OJ L 136, 24.5.2008, p. 3. (5) OJ L 144, 30.4.2004, p. 62. (6) OJ L 281, 23.11.1995, p. 31. (7) OJ L 8, 12.1.2001, p. 1. (8) OJ L 304, 22.11.2011, p. 64. (9) OJ L 55, 28.2.2011, p. 13. (10) OJ C 136, 11.5.2012, p. 1. (11) OJ L 178, 17.7.2000, p. 1. (12) OJ L 364, 9.12.2004, p. 1. (13) OJ L 110, 1.5.2009, p. 30. ANNEX Information to be provided when submitting a complaint (1) Whether the complainant party is a consumer or a trader; (2) The name and e-mail and geographical address of the consumer; (3) The name and e-mail, website and geographical address of the trader; (4) The name and email and geographical address of the complainant party\u2019s representative, if applicable; (5) The language(s) of the complainant party or representative, if applicable; (6) The language of the respondent party, if known; (7) The type of good or service to which the complaint relates; (8) Whether the good or service was offered by the trader and ordered by the consumer on a website or by other electronic means; (9) The price of the good or service purchased; (10) The date on which the consumer purchased the good or service; (11) Whether the consumer has made direct contact with the trader; (12) Whether the dispute is being or has previously been considered by an ADR entity or by a court; (13) The type of complaint; (14) The description of the complaint; (15) If the complainant party is a consumer, the ADR entities the trader is obliged to or has committed to use in accordance with Article 13(1) of Directive 2013/11/EU, if known; (16) If the complainant party is a trader, which ADR entity or entities the trader commits to or is obliged to use.", "summary": "Solving consumer\u2013trader disputes arising from online shopping Solving consumer\u2013trader disputes arising from online shopping SUMMARY OF: Regulation (EU) No 524/2013 on online dispute resolution for consumer disputes WHAT IS THE AIM OF THE REGULATION? It aims to create an online dispute resolution (ODR) platform (website) at EU level. Consumers and traders will be able to use the platform to resolve disputes when they have a problem with a product or service that they have bought anywhere in the European Union (EU). KEY POINTS The complaint procedure involves both parties and the mediationbody (alternative dispute resolution (ADR)) they agree to use. These bodies \u2014 some of which operate online \u2014 offer a neutral party such as an ombudsman or mediator. Their job is to propose or impose a solution or to bring the parties together so they can find a solution. The entire procedure can be handled quickly online, so most disputes should be settled within 90 days. ODR platform The European Commission will develop, operate and maintain the ODR platform. It will be launched in January 2016 and will be: an interactive and user-friendly website; open to any customer or trader in the EU; available in all EU official languages; free of charge. The platform has several functions. These include offering an electronic complaint form, informing the respondent party about the complaint, identifying national mediation bodies and electronic case management. Each EU country must designate one ODR contact point, hosting at least two ODR advisers. The Commission will also set up a network of ODR contact points. Once the electronic complaint form has been submitted to the ODR platform, the platform will quickly contact and seek a response from the respondent party. It will also transmit the complaint to the mediation body that the parties agree to use. If the mediation body agrees to deal with the dispute, it will strive to resolve the dispute quickly and inform the ODR platform of the results of the procedure. Alternative dispute resolution The ODR platform can be accessed through the Your Europe portal. It will also be connected to all the national mediation bodies that have been set up and notified to the European Commission, in line with the EU alternative dispute resolution (ADR) directive. The ODR regulation and ADR directive were both adopted in May 2013. The ODR platform is accessible to consumers and traders since 15 February 2016. FROM WHEN DOES THE REGULATION APPLY? It has applied since 9 January 2016. BACKGROUND For more information, see: Alternative and Online Dispute Resolution (ADR/ODR) on the European Commission\u2019s website Consumer dispute resolution on the Your Europe website. MAIN DOCUMENT Regulation (EU) No 524/2013 of the European Parliament and of the Council of 21 May 2013 on online dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Regulation on consumer ODR) (OJ L 165, 18.6.2013, pp. 1\u201312) RELATED DOCUMENTS Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Directive on consumer ADR) (OJ L 165, 18.6.2013, pp. 63\u201379) Commission Implementing Regulation (EU) 2015/1051 of 1 July 2015 on the modalities for the exercise of the functions of the online dispute resolution platform, on the modalities of the electronic complaint form and on the modalities of the cooperation between contact points provided for in Regulation (EU) No 524/2013 of the European Parliament and of the Council on online dispute resolution for consumer disputes (OJ L 171, 2.7.2015, pp. 1\u20134) last update 30.08.2016"}
{"article": "20.12.2013 EN Official Journal of the European Union L 347/608 REGULATION (EU) No 1307/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 42 and Article 43(2) thereof, Having regard to the 1979 Act of Accession, and in particular paragraph 6 of Protocol No 4 on cotton attached thereto, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the Court of Auditors (1), Having regard to the opinions of the European Economic and Social Committee (2), Having regard to the opinion of the Committee of the Regions (3), Acting in accordance with the ordinary legislative procedure (4), Whereas: (1) The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions entitled \"The CAP towards 2020: Meeting the food, natural resources and territorial challenges of the future\" set out potential challenges, objectives and orientations for the Common Agricultural Policy (\"the CAP\") after 2013. In the light of the debate on that Communication, the CAP should be reformed with effect from 1 January 2014. That reform should cover all the main instruments of the CAP, including Council Regulation (EC) No 73/2009 (5). In view of the scope of the reform, it is appropriate to repeal Regulation (EC) No 73/2009 and to replace it with a new text. The reform should also streamline and simplify the relevant provisions. (2) One of the core objectives, and one of the key requirements, of the CAP reform is the reduction of the administrative burden. This should be taken firmly into account when shaping the relevant provisions for the direct support scheme. (3) All the basic elements pertaining to the payment of Union support to farmers should be included in this Regulation, which should also fix the conditions of access to payments which are inextricably linked to those basic elements. (4) It is necessary to clarify that Regulation (EU) No 1306/2013 of the European Parliament and of Council (6) and the provisions adopted pursuant to it are to apply in relation to the measures set out in this Regulation. For the sake of consistency with other legal instruments relating to the CAP, some rules currently provided for in Regulation (EC) No 73/2009 are now laid down in Regulation (EU) No 1306/2013, in particular the rules to guarantee compliance with the obligations laid down by direct payment provisions, including checks and the application of administrative measures and administrative penalties in the case of non-compliance, the rules related to cross-compliance such as the statutory management requirements, the good agricultural and environmental condition, the monitoring and evaluation of relevant measures and the rules related to the payment of advances and the recovery of undue payments. (5) In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (6) This Regulation should contain a list of the direct payment support schemes covered by it. In order to take into account new legislation on support schemes which may be adopted after the entry into force of this Regulation, the power to adopt certain acts should be delegated to the Commission in respect of the amendment of that list. (7) In order to ensure legal certainty, the power to adopt certain acts should be delegated to the Commission in respect of establishing the framework within which Member States are to define the criteria to be met by farmers in order to fulfil the obligation to maintain the agricultural area in a state suitable for grazing or cultivation, and the minimum activities to be carried out on areas naturally kept in a state suitable for grazing or cultivation, as well as the criteria to determine the predominance of grasses and other herbaceous forage and to determine the established local practices as regards permanent grassland and permanent pasture ('permanent grassland'). (8) With a view to ensuring that the amounts for the financing of the CAP comply with the annual ceilings referred to in Article 16(1) of Regulation (EU) No 1306/2013, an adjustment of the level of direct support in any calendar year should be made as provided for under Article 25 of that Regulation. In order to ensure that it contributes to achieving the objective of a more balanced distribution of payments between small and large beneficiaries, the adjustment of the direct payments should only be applied to payments to be granted to farmers in excess of EUR 2 000 in the corresponding calendar year. Taking into account the levels of direct payments to farmers in Bulgaria, Croatia and Romania in the framework of the application of the phasing-in mechanism to all direct payments granted in those Member States, this instrument of financial discipline should only apply in Bulgaria and Romania from 1 January 2016, and in Croatia from 1 January 2022. Specific rules should be laid down in respect of that instrument of financial discipline and of certain other provisions in the case of a legal person, or a group of natural or legal persons, where national law provides for individual members' rights and obligations comparable to those of individual farmers who have the status of a head of holding, in order to strengthen the agricultural structures and promote the establishment of the legal persons or groups concerned. (9) In order to ensure the correct application of the adjustment of direct payments with respect to financial discipline, the power to adopt certain acts should be delegated to the Commission in respect of rules on the basis for calculation of reductions to be applied by Member States to farmers pursuant to the application of the financial discipline. (10) Experience acquired in the application of the various support schemes for farmers has shown that support was in a number of cases granted to natural or legal persons whose business purpose was not, or was only marginally targeted at an agricultural activity. To ensure that support is better targeted, Member States should refrain from granting direct payments to certain natural and legal persons unless such persons can demonstrate that their agricultural activity is not marginal. Member States should also have the possibility of not granting direct payments to other natural or legal persons whose agricultural activity is marginal. However, Member States should be allowed to grant direct payments to smaller part-time farmers, since those farmers contribute directly to the vitality of rural areas. Member States should also refrain from granting direct payments to natural or legal persons whose agricultural areas are mainly areas naturally kept in a state suitable for grazing or cultivation and who do not carry out a certain minimum activity. (11) In order to guarantee the protection of the rights of farmers, the power to adopt certain acts should be delegated to the Commission in respect of laying down criteria for determining the cases where a farmer's agricultural area is to be considered to be mainly an area naturally kept in a state suitable for grazing or cultivation, criteria to establish the distinction between receipts resulting from agricultural and from non-agricultural activities and the amount of direct payments relevant for applying the marginality test, and criteria to be met by farmers in order to prove that their agricultural activity is not marginal. (12) To avoid the excessive administrative burden caused by managing payments of small amounts, Member States should in general refrain from granting direct payments where the amount would be lower than EUR 100, or where the eligible area of the holding for which support is claimed would be less than one hectare. However, as Member States' farming structures vary considerably and may differ significantly from the average farming structure in the Union, Member States should be allowed to apply minimum thresholds that reflect their particular situation. Due to the very specific farming structure in the outermost regions and the smaller Aegean Islands, Member States should be able to decide whether any minimum threshold should apply in those regions. Moreover, Member States should opt for the implementation of one of the two types of minimum threshold, taking account of the particularities of the structures of their farming sectors. Since payment could be granted to farmers with so-called 'landless' holdings, the application of the hectare-based threshold would be ineffective. The support-related minimum amount should therefore apply to such farmers. To ensure the equal treatment of farmers in Bulgaria, Croatia and Romania whose direct payments are subject to phasing-in, the minimum threshold should, in those Member States, be based on the final amounts to be granted at the end of the phasing-in process. (13) The distribution of direct income support among farmers is characterised by the allocation of disproportionate amounts of payments to a rather small number of large beneficiaries. Larger beneficiaries, due to their ability to exploit economies of size, do not require the same level of unitary support in order for the objective of income support to be efficiently achieved. Moreover, the potential to adapt makes it easier for larger beneficiaries to operate with lower levels of unitary support. Member States should therefore reduce by at least 5 % the part of the basic payment to be granted to farmers which exceeds EUR 150 000. To avoid disproportionate effects on large farms with high employment numbers, Member States may decide to take into account salaried labour intensity when applying the mechanism. In order to make such reduction of the support level effective, no advantage should be granted to farmers who artificially create the conditions to avoid its effects. The proceeds of the reduction of payments to large beneficiaries should remain in the Member States where they were generated and should be made available as Union support for measures financed under the European Agricultural Fund for Rural Development (EAFRD). (14) Net ceilings should be determined for each Member State in order to limit the payments to be made to farmers following the application of the reduction of payments. To take into account the specific characteristics of CAP support granted in accordance with Regulation (EU) No 228/2013 of the European Parliament and of the Council (7) and Regulation (EU) No 229/2013 of the European Parliament and of the Council (8), and the fact that these direct payments are not subject to reduction of payments, the net ceiling for the Member States concerned should not include those direct payments. (15) In order to take account of the developments relating to the total maximum amounts of direct payments that may be granted, including those resulting from the decisions to be taken by the Member States regarding transfers between the first and second pillars and the application of the reduction and, where applicable, capping of payments, as well as those resulting from the notifications to be made by Croatia regarding the de-mined land that has returned to use for agricultural activities, the power to adopt certain acts should be delegated to the Commission in respect of adapting the national and net ceilings set out in this Regulation. (16) It should be specified that those provisions of this Regulation which could give rise to behaviour of a Member State capable of constituting State aid are excluded from the application of the State aid rules, given that the provisions concerned include appropriate conditions for the granting of support, or envisage the adoption of such conditions by the Commission, in order to prevent any undue distortion of competition. (17) With a view to strengthening their rural development policy, Member States should be given the possibility to transfer funds from their direct payments ceiling to their support assigned for rural development. Member States should also be given the possibility to transfer funds from their support assigned for rural development to their direct payments ceiling. To ensure the effectiveness of this tool, Member States should be given the possibility to review their initial decision once, with effect from claim year 2018, provided that any decision based on such review does not entail any decrease in the amounts assigned for rural development. (18) In order to achieve the objectives of the CAP, the support schemes may need to be adapted to changing developments, if necessary within short time-limits. Therefore, it is necessary to provide for a possible review of the support schemes, in particular in the light of economic developments or the budgetary situation, with the result that beneficiaries cannot assume that support conditions remain unchanged. (19) Farmers in Member States which acceded to the Union on or after 1 May 2004 received direct payments following a phasing-in mechanism provided for in the respective Acts of Accession. For Bulgaria and Romania, such mechanism will still be in force in 2015, and for Croatia, it will be in force until 2021. Furthermore, those Member States were allowed to grant complementary national direct payments. The possibility for granting such payments should be maintained for Croatia and, as a complement to the basic payment scheme for Bulgaria and Romania, until they are fully phased-in. As regards authorising Croatia to grant complementary national direct payments, the Commission should be empowered to adopt implementing acts without applying Regulation (EU) No 182/2011 of the European Parliament and of the Council (9). (20) Regulation (EC) No 73/2009, as amended by the Act of Accession of 2011, provides for a special national de-mining reserve for Croatia in order to finance, for a period of ten years after its accession to the Union, the allocation of payment entitlements to land which is de-mined and returned to agricultural use every year. It is appropriate to set the rules for determining the amounts allotted to funding support for that land under the support schemes provided for in this Regulation and the rules for the management of that reserve. In order to take account of the amounts resulting from the notifications to be made by Croatia regarding the de-mined land that has returned to use for agricultural activities, the power to adopt certain acts should be delegated to the Commission in respect of reviewing certain financial provisions applying to Croatia. (21) In order to ensure a better distribution of support across agricultural land in the Union, including in those Member States which applied the single area payment scheme established under Regulation (EC) No 73/2009, a new basic payment scheme should replace the single payment scheme established under Council Regulation (EC) No 1782/2003 (10), and continued under Regulation (EC) No 73/2009, which combined previously existing support mechanisms in a single scheme of decoupled direct payments. Such a move should, in principle, result in the expiry of payment entitlements obtained under those Regulations and the allocation of new ones. That allocation of new payment entitlements should be based, as a general rule, on the number of eligible hectares at the disposal of farmers in the first year of implementation of the scheme. However, Member States which currently operate the single payment scheme on a regional or regional hybrid basis should have the possibility of keeping their existing payment entitlements. In order to avoid a situation in a given Member State in which an increase in the eligible area dilutes disproportionately the amount of direct payments per hectare and thus affects the internal convergence process, Member States should be allowed, when carrying out the first allocation of payment entitlements, to apply certain limitations for the purpose of establishing the number of payment entitlements. (22) Due to the successive integration of various sectors into the single payment scheme and the subsequent period of adjustment granted to farmers, it has become increasingly difficult to justify the existence of significant individual differences in the level of support per hectare resulting from use of historical references. Therefore, direct income support should be more equitably distributed between Member States, by reducing the link to historical references and having regard to the overall context of the Union budget. To ensure a more equal distribution of direct support, while taking account of the differences that still exist in wage levels and input costs, the levels of direct support per hectare should be progressively adjusted. Member States that have direct payments below the level of 90 % of the Union average should close one third of the gap between their current level and this level, with all Member States arriving at a minimum level by financial year 2020. This convergence should be financed proportionally by all Member States that have direct payment levels above the Union average level. (23) In addition, as a general rule, all payment entitlements activated in 2019 in a Member State or in a region should have a uniform unit value. However, in order to avoid disruptive financial consequences for farmers, Member States should be allowed to take historical factors into account when calculating the value of payment entitlements which farmers should have in 2019, provided that no payment entitlements in 2019 have a value lower than 60 % of the average. Member States should finance this convergence by reducing, on the basis of objective and non-discriminative criteria which they are to establish, the value of payment entitlements that exceeds the 2019 average. In this context and in order to avoid unacceptably disruptive losses for certain farmers, Member States may limit this reduction to 30 % of the initial value of the concerned entitlements, even if such a limitation does not allow for all payment entitlements to reach 60 % of the average value for 2019. Except for those Member States that opt for a uniform unit value from the first year of implementation of the scheme, the convergence should be made in equal steps. The convergence of the payment entitlements with a value above the average should also take account of the estimated resources available for payment entitlements. However, for those Member States which keep their existing payment entitlements and which have already opted for convergence steps in accordance with Article 63(3) of Regulation (EC) No 1782/2003, those convergence steps should be implemented, where applicable, and the value of all payment entitlements should be adjusted to take account of the estimated resources available for payment entitlements. (24) The experience gained through applying the single payment scheme has shown that some of its main elements should be kept, including the determination of national ceilings to ensure that the total level of support does not exceed current budgetary constraints. Member States should also continue to operate a national reserve, or should be allowed to establish regional reserves. Such national or regional reserves should be used, as a matter of priority, to facilitate the participation of young farmers and farmers commencing their agricultural activity in the scheme and using them should be allowed in order to take account of certain other specific situations. Rules on the transfer and use of payment entitlements should be retained. (25) The experience gained through applying Regulation (EC) No 73/2009 has shown that Member States did not use the entire amount of the funds available under the national ceilings laid down in that Regulation. While, compared to the system under that Regulation, this Regulation reduces the risk of unspent funds Member States should nonetheless have the possibility of distributing payment entitlements for a higher value than the amount available for their basic payment scheme, in order to facilitate a more efficient use of the funds. Member States should therefore be allowed, within certain common limits and in respect of the net ceilings for direct payments, to calculate the necessary amount by which their basic payment ceiling may be increased. (26) As a general rule, any agricultural area of the holding, including areas that were not in good agricultural condition on 30 June 2003 in Member States acceding to the Union on 1 May 2004 that opted to apply the single area payment scheme, that is used for an agricultural activity is eligible to benefit from the basic payment. Given the potential for non-agricultural activities to contribute to the income diversification of agricultural holdings and to the vitality of rural areas, an agricultural area of a holding that is used also for non-agricultural activities is to be considered eligible on condition that it is used predominantly for agricultural activities. For the purpose of assessing that predominance, common criteria should be set for all Member States. In this context and in order to ensure better targeting of direct payments, it should be possible for Member States to draw up, in the interests of legal certainty and clarity, a list of areas which are predominantly used for non-agricultural activities and are hence ineligible. Furthermore, in order to maintain the eligibility of land that was eligible for the purpose of activating set-aside entitlements prior to the abolition of the set-aside obligation, it should be provided that certain afforested areas, including those afforested under national schemes complying with the relevant rules in Council Regulation (EC) No 1698/2005 (11) or Regulation (EU) No 1305/2013 of the European Parliament and of the Council (12), or areas subject to certain environmental commitments, are eligible to benefit from the basic payment. (27) In order to avoid a situation in which, in a given Member State, an increase in the eligible area dilutes disproportionately the amount of direct payments per hectare and thus affects the internal convergence process, Member States should be allowed to use a reduction coefficient for determining the eligible area of permanent grassland where grasses and other herbaceous forage are traditionally not predominant in grazing areas, but form part of established local practices. (28) As regards hemp, specific measures should be kept to ensure that illegal crops cannot be hidden among the crops eligible for the basic payment, thereby adversely affecting the market for hemp. Hence, payments should continue to be granted only for areas sown with varieties of hemp offering certain guarantees with regard to its psychotropic substance content. (29) In order to ensure legal certainty, and in order to clarify the specific situations that may arise in the application of the basic payment scheme, the power to adopt certain acts should be delegated to the Commission in respect of rules on eligibility and access in respect of the basic payment scheme of farmers, in the case of inheritance and anticipated inheritance, inheritance under a lease, change of legal status or denomination, transfer of payment entitlements, and in the case of a merger or scission of the holding and in the case of a contract clause regarding the right to receive payment entitlements in the first year of allocation of payment entitlements. Moreover, that delegation of power should also cover rules on the calculation of the value and number or on the change in the value of payment entitlements in relation to the allocation of payment entitlements, including rules on the possibility of a provisional value and number or of a provisional increase of payment entitlements allocated on the basis of the application from the farmer, on the conditions for establishing the provisional and definitive value and number of the payment entitlements and on the cases where a sale or lease contract could affect the allocation of payment entitlements. Furthermore, that delegation of power should also cover rules on the establishment and calculation of the value and number of payment entitlements received from the national reserve or regional reserves; rules on the modification of the unit value of payment entitlements in the case of fractions of payment entitlements and the transfer of payment entitlements without land. In addition, that delegation of power should also cover criteria for the allocation of payment entitlements to farmers who did not receive direct payments in 2013 or pursuant to the use of the national or regional reserve; criteria for applying limitations on the number of payment entitlements to be allocated; and criteria for setting the reduction coefficient for conversion of certain permanent grassland to eligible hectares. (30) In order to ensure the proper management of payment entitlements, the power to adopt certain acts should be delegated to the Commission in respect of rules on the content of the declaration and the requirements for the activation of payment entitlements. (31) In order to preserve public health, the power to adopt certain acts should be delegated to the Commission in respect of laying down rules making the granting of payments conditional upon the use of certified seeds of certain hemp varieties and defining the procedure for the determination of hemp varieties and the verification of their tetrahydrocannabinol content. (32) In view of the considerable administrative, technical and logistical difficulties the transition to the basic payment scheme represents for the Member States applying the single area payment scheme under Regulation (EC) No 73/2009, they should be allowed to apply the single area payment scheme for the purpose of granting the basic payment for a further transitional period until the end of 2020 at the latest. If a Member State decides to introduce the basic payment scheme by 2018, it may opt for differentiating the payments under the single area payment scheme according to the level of certain payments granted in 2014 under the regimes for specific support and separate payments provided for in Regulation (EC) No 73/2009, or, in the case of Cyprus, under the sector-specific financial envelopes for transitional national aid. (33) In order to guarantee the protection of the rights of beneficiaries and in order to clarify the specific situations that may arise in the application of the single area payment scheme, the power to adopt certain acts should be delegated to the Commission in respect of laying down rules on eligibility and access in respect of the single area payment scheme of farmers. (34) In Member States applying the single area payment scheme which were allowed to grant transitional national aid, such aid has played an important role in supporting the income of farmers in specific sectors. For that reason, and in order to avoid a sudden and substantial decrease of support from 2015 in those sectors benefiting, until 2014, from transitional national aid, it is appropriate to provide, in those Member States, for the possibility to grant that aid as a complement to the single area payment scheme. In order to ensure the continuity of the support with the transitional national aid granted so far, it is appropriate to limit the conditions to those applicable in 2013 to that aid, or in the case of Bulgaria and Romania to complementary national direct payments, authorised by the Commission following the requests from Member States. It is also appropriate to limit the maximum amounts of aid by sector, compared to their levels in 2013, to ensure a steady decrease of the aid levels and to ensure their compatibility with the convergence mechanism. (35) Specific rules should be provided for the first allocation and for the calculation of the value of payment entitlements when Member States having applied the single area payment scheme pursuant to this Regulation introduce the basic payment scheme. In order to ensure a smooth transition between those schemes, the power to adopt certain acts should be delegated to the Commission in respect of further rules on the introduction of the basic payment scheme in Member States having applied the single area payment scheme. (36) Taking into account the need for the unitary support to farmers with smaller holdings to be sufficient in order to achieve the objective of income support effectively, Member States should be allowed to redistribute direct support between farmers by granting them an extra payment for the first hectares. (37) One of the objectives of the new CAP is the enhancement of environmental performance through a mandatory \"greening\" component of direct payments which will support agricultural practices beneficial for the climate and the environment applicable throughout the Union. For that purpose, Member States should use part of their national ceilings for direct payments in order to grant, on top of the basic payment, an annual payment which may take account of internal convergence in the Member State or region, for compulsory practices to be followed by farmers addressing, as a priority, both climate and environment policy goals. Those practices should take the form of simple, generalised, non-contractual and annual actions that go beyond cross-compliance and that are linked to agriculture, such as crop diversification, the maintenance of permanent grassland, including traditional orchards where fruit trees are grown in low density on grassland, and the establishment of ecological focus areas. In order to better achieve the objectives of \"greening\" and to allow for its efficient administration and control, such practices should apply to the whole eligible area of the holding. The compulsory nature of those practices should also concern farmers whose holdings are fully or partly situated in \"Natura 2000\" areas covered by Council Directive 92/43/EEC (13) and by Directive 2009/147/EC of the European Parliament and of the Council (14), or in areas covered by Directive 2000/60/EC of the European Parliament and of the Council (15), as long as those practices are compatible with the objectives of those Directives. (38) Given the recognised environmental benefits of the organic farming systems, farmers should, for those units of their holding on which they fulfil the conditions laid down in Council Regulation (EC) No 834/2007 (16), benefit from the \"greening\" component without needing to fulfil any further obligation. (39) Failure to respect the \"greening\" component should lead to penalties on the basis of Regulation (EU) No 1306/2013. (40) In order to accommodate the diversity of agricultural systems and the different environmental situations across the Union, it is justified to recognise, in addition to the three greening practices established in this Regulation, practices covered by agri-environment-climate measures or certification schemes that are similar to greening and that yield an equivalent or higher level of benefit for the climate and the environment. For reasons of legal clarity these practices should be laid down in an Annex to this Regulation. Member States should decide whether to offer to farmers the possibility of using equivalent practices and the greening practices established in this Regulation in order to require the farmer to observe the practices best suited to ensure the objectives of the measure and they should notify the Commission of their decisions. For reasons of legal certainty, the Commission should assess whether the practices covered by the notified equivalent measures are covered by the Annex. If the Commission considers this not to be the case, it should notify Member States accordingly by means of an implementing act adopted without applying Regulation (EU) No 182/2011. In order to allow a simpler implementation of equivalence and for reasons of controllability, rules should be laid down as regards the area coverage of equivalent measures, taking into account the specific characteristics of agri-environment-climate measures and certification schemes. In order to ensure that equivalent practices are properly applied and that double funding is avoided, the power to adopt certain acts should be delegated to the Commission for the purpose of adding practices to the list of equivalent practices, establishing requirements for the national or regional certification schemes and, where necessary, establishing detailed rules for the calculation of related amounts. (41) The obligations relating to crop diversification should be applied in a way that takes into account the difficulty for smaller farms to diversify, while continuing to make progress towards enhanced environmental benefit, and in particular the improvement of soil quality. Exceptions should be provided for farms that already fulfil the objectives of crop diversification as a result of being covered to a significant extent by grassland or fallowland, for specialised farms rotating their parcels each year or for farms that because of their geographical localisation would have excessive difficulties in introducing a third crop. In order to ensure that the obligations referred to in the crop diversification measure are applied in a proportionate and non-discriminatory way and lead to an enhanced environmental protection, the power to adopt certain acts should be delegated to the Commission in respect of recognising further genera and species and laying down rules concerning the application of the precise calculation of shares of different crops. (42) For the sake of the environmental benefits of permanent grassland and in particular carbon sequestration, provision should be made for the maintenance of permanent grassland. This protection should consist of a ban on ploughing and conversion on the environmentally most sensitive areas in \"Natura 2000\" areas covered by Directives 92/43/EEC and 2009/147/EC, and of a more general safeguard, based on a ratio of permanent grassland, against conversion to other uses. Member States should be empowered to delineate further environmentally sensitive areas not covered by those Directives. In addition, they should choose at which territorial level the ratio should apply. In order to assure an efficient protection of permanent grassland, the power to adopt certain acts should be delegated to the Commission for the purpose of defining the framework for the designation, by Member States, of permanent grasslands not covered by Directives 92/43/EEC or 2009/147/EC. (43) In order to ensure that the ratio of permanent grassland to the total agricultural area is correctly determined and maintained, the power to adopt certain acts should be delegated to the Commission in respect of the establishment of detailed methods for the determination of that ratio, detailed rules on maintenance of permanent grassland and the relevant time frame for an obligation upon individual farmers to reconvert land. (44) Ecological focus areas should be established, in particular, in order to safeguard and improve biodiversity on farms. The ecological focus area should therefore consist of areas directly affecting biodiversity such as land lying fallow, landscape features, terraces, buffer strips, afforested areas and agro-forestry areas, or indirectly affecting biodiversity through a reduced use of inputs on the farm, such as areas covered by catch crops and winter green cover. The obligations laid down in respect of the ecological focus area should be applied in a way that avoids putting a disproportionate burden on smaller farms in comparison to the additional enhanced environmental benefit. Exceptions should be provided for farms that already fulfil the objectives of ecological focus areas by being covered to a significant extent by grassland or fallowland. Exceptions should also be provided, in the case of predominantly forested Member States, for farmers that pursue an agricultural activity in areas facing natural constraints in certain predominantly forested areas where there is a significant risk of land abandonment. In addition, provision should be made for the possibility for Member States and farmers to implement at a regional or collective level the obligation in order to obtain adjacent ecological focus areas that are more beneficial for the environment. For the sake of simplification, Member States should have the option to standardise the measurement of the ecological focus areas. (45) In order to ensure the that ecological focus areas are established in an efficient and coherent way, while taking into account Member States' specific characteristics, the power to adopt certain acts should be delegated to the Commission in respect of laying down further criteria for the qualification of areas as ecological focus areas; recognising other types of ecological focus areas; establishing conversion and weighting factors for certain types of ecological focus area; establishing rules for the implementation, by Member States, of a part of the ecological focus area at regional level; laying down rules for collective implementation of the obligation to keep ecological focus areas by holdings in close proximity; establishing the framework for the criteria, to be defined by Member States, for identifying such close proximity; and establishing the methods of determination of the ratio of forest to agricultural land. When adding other types of ecological focus area, the Commission should ensure that they aim to improve the general environmental performance of the holding, in particular as regards biodiversity, the improvement of soil and water quality, the preservation of landscape and meeting the climate change mitigation and adaptation objectives. (46) In order to promote the sustainable development of agriculture in areas with specific natural constraints, Member States should be able to use part of their direct payments ceilings to grant an annual area-based payment, on top of the basic payment, to all farmers operating in those areas or in some of those areas, where decided by the Member State. That payment should not replace the support given under rural development programmes and should not be granted to farmers in areas which were designated in accordance with Regulation (EC) No 1698/2005 but have not been designated in accordance with Regulation (EU) No 1305/2013. (47) The creation and development of new economic activity in the agricultural sector by young farmers is financially challenging and constitutes an element that should be considered in the allocation and targeting of direct payments. This development is essential for the competitiveness of the agricultural sector in the Union and, for that reason, an income support to young farmers commencing their agricultural activities should be established in order to facilitate the initial establishment of young farmers and the structural adjustment of their holdings after the initial setting up. For that purpose, Member States should use part of their national ceilings for direct payments to grant to young farmers an annual payment, on top of the basic payment. Member States should be able to decide on a calculation method for that payment and, if that method implies an obligation to set a limit on the payment per farmer, such a limit is to be set in respect of the general principles of Union law. Since it should only cover the initial period of the life of the business and should not become an operating aid, that payment should only be granted during a maximum period of five years. It should be available to young farmers commencing their agricultural activity who are no more than 40 years of age in the year of the first submission of the application under the basic payment scheme or under the single area payment scheme. (48) In order to guarantee the protection of the rights of beneficiaries and to avoid discrimination between them, the power to adopt certain acts should be delegated to the Commission in respect of defining the conditions under which a legal person may be considered eligible for receiving the payment for young farmers. (49) Member States should be allowed to use part of their national ceilings for direct payments for coupled support in certain sectors or regions in clearly defined cases. The resources that may be used for any coupled support should be limited to an appropriate level, while allowing such support to be granted in Member States in their specific sectors or regions facing particular situations where specific types of farming or specific agricultural sectors are particularly important for economic, environmental and/or social reasons. Member States should be allowed to use up to 8 % of their national ceilings for this support, or 13 % where their level of coupled support exceeds 5 % in at least one of the years of the period 2010-2014 or where they apply the single area payment scheme until 31 December 2014. Furthermore, in order to maintain the protein-based autonomy of the breeding sector, Member States which decide to use at least 2 % of their national ceilings to support the production of protein crops should be allowed to increase those percentages by up to two percentage points. In duly justified cases where certain sensitive needs in a sector or a region are demonstrated, and upon approval by the Commission, Member States should be allowed to use more than 13 % of their national ceiling. As an alternative to those percentages, Member States may choose to use up to EUR 3 million per year for financing the coupled support. Coupled support should only be granted to the extent necessary to create an incentive to maintain current levels of production in the sectors or regions concerned. That support should also be available to farmers holding, on31 December 2013, special payment entitlements allocated under Regulation (EC) No 1782/2003 and Regulation (EC) No 73/2009, and who do not have eligible hectares for the activation of payment entitlements. As regards the approval of voluntary coupled support exceeding 13 % of the annual national ceiling fixed per Member State, the Commission should be further empowered to adopt implementing acts without applying Regulation (EU) No 182/2011. (50) In order to ensure efficient and targeted use of Union funds and to avoid double funding under other similar support instruments, the power to adopt certain acts should be delegated to the Commission in respect of establishing the conditions for granting voluntary coupled support, as well as rules on its consistency with other Union measures and on the cumulation of support. (51) In order to ensure against any risk of disruption to production in the cotton producing regions, a part of support to the cotton sector under Regulation (EC) No 73/2009 continued to be linked to the cultivation of cotton through a crop-specific payment per eligible hectare, taking into account all relevant factors. This situation should be maintained in accordance with the objectives set out in Protocol No 4 on cotton attached to the 1979 Act of Accession. (52) In order to ensure the efficient application and management of the crop-specific payment for cotton, the power to adopt certain acts should be delegated to the Commission in respect of establishing rules and conditions for the authorisation of land and varieties for the purposes of the crop-specific payment for cotton; rules on the conditions for the granting of that payment, on the eligibility requirements and the agronomic practices; criteria for the approval of interbranch organisations; obligations for producers; and rules governing the situation where the approved interbranch organisation does not satisfy those criteria. (53) Chapter 2 of Council Regulation (EC) No 637/2008 (17) required each cotton producing Member State to submit to the Commission either every four years and for the first time by 1 January 2009 a draft four-year restructuring programme, or by 31 December 2009 a single draft modified eight-year restructuring programme. Experience has shown that the restructuring of the cotton sector would be better served through other measures, including those under rural development programming financed under Regulation (EU) No 1305/2013. Such measures would also allow for a greater co-ordination with measures in other sectors. The acquired rights and legitimate expectations of undertakings already involved in restructuring programmes should, however, be respected. Therefore, the ongoing programmes of four or eight years should be allowed to run their course, with no possiblity of extension. Funds available from the four-year programmes could then be integrated into the available Union funds for measures under rural development from 2014. Given the programming period, funds available after the end of the eight-year programmes would not be useful in rural development programmes in 2018, and could therefore be more usefully transferred to support schemes under this Regulation, as already provided for in Regulation (EC) No 637/2008. Regulation (EC) No 637/2008 will therefore become obsolete from 1 January 2014 or 1 January 2018 as regards Member States which have, respectively, four or eight-year programmes and should therefore be repealed. (54) Member States should be allowed to establish a simple and specific scheme for small farmers in order to reduce the administrative costs linked to the management and control of direct support. For that purpose, Member States should be allowed to establish either a lump-sum payment that replaces all direct payments, or a payment based on the amount due to the farmers each year. Rules simplifying formalities should be introduced by reducing, inter alia, the obligations imposed on small farmers, such as those related to the application for support, to agricultural practices beneficial for the climate and the environment, to cross-compliance and to controls as laid down in Regulation (EU) No 1306/2013 without jeopardising the achievement of the overall objectives of the reform, it being understood that Union legislation as referred to in Annex II to Regulation (EU) No 1306/2013 applies to small farmers. The objective of that scheme should be to support the existing agricultural structure of small farms in the Union without countering the development towards more competitive structures. For that reason, access to the scheme should, in principle, be limited to existing holdings. Participation of farmers in the scheme should be optional. However, in order to further increase the impact of the scheme in terms of simplification, Member States should be allowed to include certain farmers in the scheme automatically, subject to the possibility for them to opt-out. (55) In order to ensure legal certainty, the power to adopt certain acts should be delegated to the Commission in respect of establishing conditions for participation in the small farmers scheme if the situation of the participating farmer changes. (56) In the interest of simplification and in order to take into account the specific situation of the outermost regions, direct payments in those regions should be managed within the support programmes established by Regulation (EU) No 228/2013. As a consequence, provisions in this Regulation relating to the basic payment and related payments, to coupled support and to the small farmers scheme should not apply to those regions. (57) Notifications are needed from Member States for the purpose of applying this Regulation, and for the purpose of monitoring, analysing and managing direct payments. In order to ensure the correct application of the rules set out in this Regulation and to make such notifications fast, efficient, accurate, cost-effective and compatible with the protection of personal data, the power to adopt certain acts should be delegated to the Commission in respect of establishing the necessary measures regarding notifications to be made by Member States to the Commission or for the purpose of checking, controlling, monitoring, evaluating and auditing direct payments and for complying with requirements laid down in international agreements, including notification requirements under those agreements and in respect of further rules on the nature and type of the information to be notified, the categories of data to be processed and maximum period of retention, the access rights to the information or information systems and the conditions of publication of the information. (58) Personal data collected for the purposes of the application of direct payments should be processed in a way that is compatible with those purposes. It should also be made anonymous, be aggregated when processed for monitoring or evaluation purposes, and be protected in accordance with Union law concerning the protection of individuals with regard to the processing of personal data and on the free movement of such data, in particular Directive 95/46/EC of the European Parliament and of the Council (18) and Regulation (EC) No 45/2001 of the European Parliament and of the Council (19). Data subjects should be informed of such processing and of their data protection rights. (59) The European Data Protection Supervisor was consulted and delivered an opinion on 14 December 2011 (20). (60) In order to ensure a smooth transition from the arrangements provided for in Regulation (EC) No 73/2009 to those laid down in this Regulation, the power to adopt certain acts should be delegated to the Commission in respect of establishing the necessary measures to protect any acquired rights and legitimate expectations of farmers. (61) In order to ensure uniform conditions for the implementation of this Regulation and to avoid unfair competition or discrimination between farmers, implementing powers should be conferred on the Commission in respect of: setting the amount to be included in the special national de-mining reserve for Croatia; fixing the annual national ceiling for the basic payment scheme; adopting rules on applications for allocation of payment entitlements; adopting measures regarding the reversion of non-activated payment entitlements to the national reserve; adopting modalities of the notification of transfer of payment entitlements to the national authorities and the deadlines within which such notifications are to take place; fixing the annual national ceiling for the single area payment scheme; adopting rules on applications for allocation of payment entitlements submitted in the year of allocation of payment entitlements where Member States change to the basic payment scheme; fixing annual ceilings for the redistributive payment. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. (62) In order to ensure uniform conditions for the implementation of this Regulation and to avoid unfair competition or discrimination between farmers, implementing powers should also be conferred on the Commission in respect of: adopting rules on the procedure, including on the timetables for their submission, for the Member States' notifications and the Commission assessment as regards equivalent practices; adopting certain limits within which the obligation to maintain permanent grassland is considered to be being complied with; setting out the annual ceiling for the payment for agricultural practices beneficial for the climate and the environment; setting out the annual ceiling for the payment for areas with natural constraints; setting out the annual ceiling for the payment for young farmers. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. (63) In order to ensure uniform conditions for the implementation of this Regulation and to avoid unfair competition or discrimination between farmers, implementing powers should also be conferred on the Commission in respect of: setting out the annual ceilings for the voluntary coupled support; adopting rules on the procedure for the assessment and approval of decisions in the framework of the voluntary coupled support; adopting rules on the authorisation procedure and on the notifications to the producers related to the authorisation of land and varieties for the purposes of the crop-specific payment for cotton; adopting rules on the calculation of the reduction of the amount of the crop-specific payment for cotton; adopting rules concerning general notification requirements and methods; and adopting necessary and justifiable measures to resolve specific problems in an emergency. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. (64) In order to solve urgent problems occurring in one or more Member States while ensuring the continuity of the direct payments system, the Commission should adopt immediately applicable implementing acts where, in duly justified cases, extraordinary circumstances affect the granting of support and jeopardise the effective implementation of the payments under the support schemes listed in this Regulation. (65) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the links between this Regulation and the other instruments of the CAP, the disparities between the various rural areas and the limited financial resources of the Member States in an enlarged Union, be better achieved at Union level through the multiannual guarantee of Union financing and by concentrating on clearly identified priorities, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (66) Given that Regulation (EC) No 73/2009 is to continue to apply in 2014, this Regulation should apply in general from 1 January 2015. However, the provisions of this Regulation on flexibility between pillars provide for the possibility for Member States to take decisions and notify them to the Commssion by 31 December 2013. In addition, some other provisions of this Regulation require action to be taken in 2014. Those provisions should, therefore, apply from the entry into force of this Regulation. (67) Due to the urgency of preparing the smooth implementation of the measures envisaged, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: TITLE I SCOPE AND DEFINITIONS Article 1 Scope This Regulation establishes: (a) common rules on payments granted directly to farmers under the support schemes listed in Annex I (\"direct payments\"); (b) specific rules concerning: (i) a basic payment for farmers (\"the basic payment scheme\" and a transitional simplified scheme, \"the single area payment scheme\"); (ii) a voluntary transitional national aid for farmers; (iii) a voluntary redistributive payment; (iv) a payment for farmers observing agricultural practices beneficial for the climate and the environment; (v) a voluntary payment for farmers in areas with natural constraints; (vi) a payment for young farmers commencing their agricultural activity; (vii) a voluntary coupled support scheme; (viii) a crop-specific payment for cotton; (ix) a voluntary simplified scheme for small farmers; (x) a framework within which Bulgaria, Croatia and Romania may complement direct payments. Article 2 Amendment of Annex I In order to ensure legal certainty, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 amending the list of support schemes set out in Annex I to the extent necessary to take account of any new legislative acts on support schemes which may be adopted after the adoption of this Regulation. Article 3 Application to the outermost regions and the smaller Aegean islands Article 11 shall not apply to the regions of the Union referred to in Article 349 TFEU (\"the outermost regions\") and to the direct payments granted in the smaller Aegean islands in accordance with Regulation (EU) No 229/2013. Titles III, IV and V of this Regulation shall not apply to the outermost regions. Article 4 Definitions and related provisions 1. For the purposes of this Regulation, the following definitions shall apply: (a) \"farmer\" means a natural or legal person, or a group of natural or legal persons, regardless of the legal status granted to such group and its members by national law, whose holding is situated within the territorial scope of the Treaties, as defined in Article 52 TEU in conjunction with Articles 349 and 355 TFEU, and who exercises an agricultural activity; (b) \"holding\" means all the units used for agricultural activities and managed by a farmer situated within the territory of the same Member State; (c) \"agricultural activity\" means: (i) production, rearing or growing of agricultural products, including harvesting, milking, breeding animals, and keeping animals for farming purposes, (ii) maintaining an agricultural area in a state which makes it suitable for grazing or cultivation without preparatory action going beyond usual agricultural methods and machineries, based on criteria established by Member States on the basis of a framework established by the Commission, or (iii) carrying out a minimum activity, defined by Member States, on agricultural areas naturally kept in a state suitable for grazing or cultivation; (d) \"agricultural products\" means the products, with the exception of fishery products, listed in Annex I to the Treaties as well as cotton; (e) \"agricultural area\" means any area taken up by arable land, permanent grassland and permanent pasture, or permanent crops; (f) \"arable land\" means land cultivated for crop production or areas available for crop production but lying fallow, including areas set aside in accordance with Articles 22, 23 and 24 of Regulation (EC) No 1257/1999, with Article 39 of Regulation (EC) No 1698/2005 and with Article 28 of Regulation (EU) No 1305/2013, irrespective of whether or not that land is under greenhouses or under fixed or mobile cover; (g) \"permanent crops\" means non-rotational crops other than permanent grassland and permanent pasture that occupy the land for five years or more and yield repeated harvests, including nurseries and short rotation coppice; (h) \"permanent grassland and permanent pasture\" (together referred to as \"permanent grassland\") means land used to grow grasses or other herbaceous forage naturally (self-seeded) or through cultivation (sown) and that has not been included in the crop rotation of the holding for five years or more; it may include other species such as shrubs and/or trees which can be grazed provided that the grasses and other herbaceous forage remain predominant as well as, where Member States so decide, land which can be grazed and which forms part of established local practices where grasses and other herbaceous forage are traditionally not predominant in grazing areas; (i) \"grasses or other herbaceous forage\" means all herbaceous plants traditionally found in natural pastures or normally included in mixtures of seeds for pastures or meadows in the Member State, whether or not used for grazing animals; (j) \"nurseries\" means the following areas of young ligneous (woody) plants grown in the open air for subsequent transplantation: \u2014 vine and root-stock nurseries, \u2014 fruit tree and berries nurseries, \u2014 ornamental nurseries, \u2014 commercial nurseries of forest trees excluding those for the holding's own requirements grown within woodland, \u2014 nurseries of trees and bushes for planting in gardens, parks, at the roadside and on embankments (e.g. hedgerow plants, rose trees and other ornamental bushes, ornamental conifers), including in all cases their stocks and young seedlings; (k) \"short rotation coppice\" means areas planted with tree species of CN code 0602 90 41 to be defined by Member States that consist of woody, perennial crops, the rootstock or stools of which remain in the ground after harvesting, with new shoots emerging in the following season and with a maximum harvest cycle to be determined by the Member States; (l) \"sale\" means the sale or any other definitive transfer of ownership of land or payment entitlements; it does not include the sale of land where land is transferred to public authorities or for use in the public interest and where the transfer is carried out for non-agricultural purposes; (m) \"lease\" means a rental agreement or similar temporary transaction; (n) \"transfer\" means the lease or sale or actual inheritance or anticipated inheritance of land or payment entitlements or any other definitive transfer thereof; it does not cover the reversion of entitlements upon expiry of a lease. 2. Member States shall: (a) establish criteria to be met by farmers in order to fulfil the obligation to maintain an agricultural area in a state suitable for grazing or cultivation, as referred to in point (c)(ii) of paragraph 1; (b) where applicable in a Member State, define the minimum activity to be carried out on agricultural areas naturally kept in a state suitable for grazing or cultivation, as referred to in point (c)(iii) of paragraph 1; (c) define the tree species qualifying for short rotation coppice and determine the maximum harvest cycle in respect of those tree species, as referred to in point (k) of paragraph 1. Member States may decide that land which can be grazed and which forms part of established local practices where grasses and other herbaceous forage are traditionally not predominant in grazing areas is to be considered to be permanent grassland, as referred to in point (h) of paragraph 1. 3. In order to ensure legal certainty, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 establishing: (a) the framework within which Member States are to establish the criteria to be met by farmers in order to fulfil the obligation to maintain an agricultural area in a state suitable for grazing or cultivation, as referred to in point (c)(ii) of paragraph 1; (b) the framework within which Member States shall define the minimum activity to be carried out on agricultural areas naturally kept in a state suitable for grazing or cultivation, as referred to in point (c)(iii) of paragraph 1; (c) the criteria to determine the predominance of grasses and other herbaceous forage and the criteria to determine the established local practices referred to in point (h) of paragraph 1. TITLE II GENERAL PROVISIONS ON DIRECT PAYMENTS CHAPTER 1 Common rules on direct payments Article 5 General common agricultural policy provisions Regulation (EU) No 1306/2013 and the provisions adopted pursuant thereto shall apply to the schemes provided for in this Regulation. Article 6 National ceilings 1. For each Member State and for each year, the national ceiling comprising the total value of all allocated payment entitlements, of the national reserve or the regional reserves and of the ceilings fixed in accordance with Articles 42, 47, 49, 51 and 53 shall be as set out in Annex II. Where a Member State makes use of the option provided for in Article 22(2), the national ceiling set out in Annex II for that Member State for the respective year may be exceeded by the amount calculated in accordance with that paragraph. 2. By way of derogation from paragraph 1, for each Member State applying the single area payment scheme and for each year, the national ceiling, comprising the ceilings fixed in accordance with Articles 36, 42, 47, 49, 51 and 53, shall be as set out in Annex II. 3. In order to take account of the developments relating to the total maximum amounts of direct payments that may be granted, including those resulting from the decisions to be taken by Member States in accordance with Article 14 and those resulting from the application of Article 20(2), the Commission shall be empowered to adopt delegated acts in accordance with Article 70 adapting the national ceilings set out in Annex II. Article 7 Net ceilings 1. Without prejudice to Article 8, the total amount of direct payments which may be granted in a Member State pursuant to Titles III, IV and V in respect of a calendar year, after application of Article 11, shall not be higher than the corresponding ceiling set out in Annex III. Where the total amount of direct payments to be granted in a Member State would be higher than the ceiling set out in Annex III, that Member State shall make a linear reduction in the amounts of all direct payments with the exception of direct payments granted under Regulation (EU) No 228/2013 and Regulation (EU) No 229/2013. 2. For each Member State and for each calendar year, the estimated product of the reduction of payments referred to in Article 11 (which is reflected by the difference between the national ceiling set out in Annex II, to which is added the amount available in accordance with Article 58, and the net ceiling set out in Annex III) shall be made available as Union support for measures under rural development programming financed under the European Agricultural Fund for Rural Development (EAFRD) as specified in Regulation (EU) No 1305/2013. 3. In order to take account of the developments relating to the total maximum amounts of direct payments that may be granted, including those resulting from the decisions taken by Member States pursuant to Article 14, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 adapting the ceilings set out in Annex III. Article 8 Financial discipline 1. The adjustment rate determined in accordance with Article 26 of Regulation (EU) No 1306/2013 shall only apply to direct payments in excess of EUR 2 000 to be granted to farmers in the corresponding calendar year. 2. As a result of the gradual introduction of direct payments provided for in Article 16, paragraph 1 of this Article shall apply to Bulgaria and Romania from 1 January 2016. As a result of the gradual introduction of direct payments provided for in Article 17, paragraph 1 of this Article shall apply to Croatia from 1 January 2022. 3. In order to ensure the correct application of the adjustments of direct payments with respect to financial discipline, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down rules on the basis for calculation of reductions to be applied by Member States to farmers pursuant to paragraph 1 of this Article. 4. In the case of a legal person, or a group of natural or legal persons, Member States may apply the adjustment rate referred to in paragraph 1 at the level of the members of those legal persons or groups where national law provides for the individual members to assume rights and obligations comparable to those of individual farmers who have the status of a head of holding, in particular as regards their economic, social and tax status, provided that they have contributed to strengthening the agricultural structures of the legal persons or groups concerned. Article 9 Active farmer 1. No direct payments shall be granted to natural or legal persons, or to groups of natural or legal persons, whose agricultural areas are mainly areas naturally kept in a state suitable for grazing or cultivation and who do not carry out on those areas the minimum activity defined by Member States in accordance with point (b) of Article 4(2). 2. No direct payments shall be granted to natural or legal persons, or to groups of natural or legal persons, who operate airports, railway services, waterworks, real estate services, permanent sport and recreational grounds. Where appropriate, Member States may, on the basis of objective and non-discriminatory criteria, decide to add to the list in the first subparagraph any other similar non-agricultural businesses or activities, and may subsequently decide to withdraw any such additions. A person or group of persons falling within the scope of the first or second subparagraph shall, however, be regarded as an active farmer if it provides verifiable evidence, in the form that is required by Member States, which demonstrates any of the following: (a) that the annual amount of direct payments is at least 5 % of the total receipts that it obtained from non-agricultural activities in the most recent fiscal year for which such evidence is available; (b) that its agricultural activities are not insignificant; (c) that its principal business or company objects consist of exercising an agricultural activity. 3. In addition to paragraphs 1 and 2, Member States may decide, on the basis of objective and non-discriminatory criteria, that no direct payments are to be granted to natural or legal persons, or to groups of natural or legal persons: (a) whose agricultural activities form only an insignificant part of their overall economic activities; and/or (b) whose principal activity or company objects do not consist of exercising an agricultural activity. 4. Paragraphs 2 and 3 shall not apply to farmers who only received direct payments not exceeding a certain amount for the previous year. Such amount shall be decided by Member States on the basis of objective criteria such as their national or regional characteristics, and shall not be higher than EUR 5 000. 5. In order to guarantee the protection of the rights of farmers, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down: (a) criteria for determining the cases where a farmer's agricultural area is to be considered to be mainly an area naturally kept in a state suitable for grazing or cultivation; (b) criteria for establishing the distinction between receipts resulting from agricultural and non-agricultural activities; (c) criteria for establishing the amounts of direct payments referred to in paragraphs 2 and 4, especially concerning direct payments in the first year of allocation of payment entitlements where the value of the payment entitlements is not yet definitively established, as well as concerning direct payments for new farmers; (d) criteria that farmers are to meet in order to prove for the purposes of paragraphs 2 and 3 that their agricultural activities are not insignificant and that their principal business or company objects consist of exercising an agricultural activity. 6. Member States shall notify the Commission by 1 August 2014 of any decision referred to in paragraphs 2, 3 or 4 and, in the case of amendments thereto, within two weeks of the date on which any decision to amend was taken. Article 10 Minimum requirements for receiving direct payments 1. Member States shall decide in which one of the following cases not to grant direct payments to a farmer: (a) where the total amount of direct payments claimed or due to be granted before the application of Article 63 of Regulation (EU) No 1306/2013 in a given calendar year is less than EUR 100; (b) where the eligible area of the holding for which direct payments are claimed or due to be granted before the application of Article 63 of Regulation (EU) No 1306/2013 is less than one hectare. 2. In order to take account of the structure of their agricultural economies, Member States may adjust the thresholds set out in points (a) and (b) of paragraph 1 within the limits set out in Annex IV. 3. Where a Member State has decided to apply an area threshold pursuant to point (b) of paragraph 1, it shall nevertheless apply point (a) of that paragraph to those farmers receiving the animal-related coupled support referred to in Title IV who hold fewer hectares than the area threshold. 4. The Member States concerned may decide not to apply paragraph 1 to the outermost regions and to the smaller Aegean Islands. 5. In Bulgaria and Romania, for the year 2015, the amount claimed or due to be granted as referred to in point (a) of paragraph 1 shall be calculated on the basis of the relevant amount set out in point A of Annex V. In Croatia, for the years 2015-2021, the amount claimed or due to be granted as referred to in point (a) of paragraph 1 shall be calculated on the basis of the amount set out in point A of Annex VI. Article 11 Reduction of payments 1. Member States shall reduce the amount of direct payments to be granted to a farmer pursuant to Chapter 1 of Title III for a given calendar year by at least 5 % for the part of the amount exceeding EUR 150 000. 2. Before applying paragraph 1, Member States may subtract the salaries linked to an agricultural activity actually paid and declared by the farmer in the previous calendar year, including taxes and social contributions related to employment, from the amount of direct payments to be granted to a farmer pursuant to Chapter 1 of Title III in a given calendar year. Where no data is available on the salaries actually paid and declared by the farmer in the previous calendar year, the most recent data available shall be used. 3. Where a Member State decides to grant a redistributive payment to farmers pursuant to Chapter 2 of Title III and to use more than 5 % of the annual national ceiling set out in Annex II for that purpose, it may decide not to apply this Article. Where a Member State decides to grant a redistributive payment to farmers pursuant to Chapter 2 of Title III and the application of the maximum limits set out in Article 41(4) prevents it from using more than 5 % of the annual national ceiling set out in Annex II for that purpose, that Member State may decide not to apply this Article. 4. No advantage by means of avoiding reductions of the payment shall be granted in favour of farmers in respect of whom it is established that they artificially created, after 18 October 2011, the conditions to avoid the effects of this Article. 5. In the case of a legal person, or a group of natural or legal persons, Member States may apply the reduction referred to in paragraph 1 at the level of the members of those legal persons or groups where national law provides for the individual members to assume rights and obligations comparable to those of individual farmers who have the status of a head of holding, in particular as regards their economic, social and tax status, provided that they have contributed to strengthening the agricultural structures of the legal persons or groups concerned. 6. Member States shall notify the Commission by 1 August 2014 of the decisions taken in accordance with this Article and of any estimated product of reductions for the years 2015 to 2019. Article 12 Multiple claims The area corresponding to the number of eligible hectares in respect of which an application for a basic payment has been submitted by a farmer pursuant to Chapter 1 of Title III may be the subject of an application for any other direct payment, as well as for any other aid not covered by this Regulation, save as explicitly provided otherwise in this Regulation. Article 13 State aid By way of derogation from Article 211(1) of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (21), Articles 107, 108 and 109 TFEU shall not apply to payments made by Member States in conformity with this Regulation. Article 14 Flexibility between pillars 1. By 31 December 2013, Member States may decide to make available, as additional support for measures under rural development programming financed under the EAFRD as specified under Regulation (EU) No 1305/2013, up to 15 % of their annual national ceilings for calendar year 2014 set out in Annex VIII to Regulation (EC) No 73/2009 and of their annual national ceilings for calendar years 2015 to 2019 set out in Annex II to this Regulation. As a result, the corresponding amount shall no longer be available for granting direct payments. The decision referred to in the first subparagraph shall be notified to the Commission by 31 December 2013. That decision shall set out the percentage referred to in that subparagraph, which may vary by calendar year. Member States which do not take the decision referred to in the first subparagraph in respect of calendar year 2014 may, by 1 August 2014, take that decision in respect of calendar years 2015 to 2019. They shall notify the Commission of any such decision by that date. Member States may decide to review the decisions referred to in this paragraph with effect from calendar year 2018. Any decisions based on such review shall not result in a decrease of the percentage notified to the Commission in accordance with the first, second and third subparagraphs. Member States shall notify the Commission of any decision based on such review by 1 August 2017. 2. By 31 December 2013, Member States which do not take the decision referred to in paragraph 1 may decide to make available as direct payments up to 15 % or, in the case of Bulgaria, Estonia, Spain, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Finland, Sweden and the United Kingdom, up to 25 % of the amount allocated to support for measures under rural development programming financed under the EAFRD in the period 2015-2020, as specified in Regulation (EU) No 1305/2013. As a result, the corresponding amount shall no longer be available for support measures under rural development programming. The decision referred to in the first subparagraph shall be notified to the Commission by 31 December 2013. That decision shall set out the percentage referred to in that subparagraph, which may vary by calendar year. Member States which do not take the decision referred to in the first subparagraph in respect of financial year 2015 may, by 1 August 2014, take that decision in respect of financial years 2016 to 2020. They shall notify the Commission of any such decision by that date. Member States may decide to review the decisions referred to in this paragraph with effect for financial years 2019 and 2020. Any decisions based on such review shall not result in an increase of the percentage notified to the Commission in accordance with the first, second and third subparagraphs. Member States shall notify the Commission of any decision based on such review by 1 August 2017. Article 15 Review Support schemes listed in Annex I shall apply without prejudice to a possible review at any time in the light of economic developments and the budgetary situation. That review may lead to the adoption of legislative acts, delegated acts under Article 290 TFEU or implementing acts under Article 291 TFEU. CHAPTER 2 Provisions applying to Bulgaria, Croatia and Romania Article 16 Gradual introduction of direct payments in Bulgaria and Romania For Bulgaria and Romania, the ceilings fixed in accordance with Articles 42, 47, 49, 51, 53 and 65 shall, for 2015, be established on the basis of the amount set out in point A of Annex V. Article 17 Gradual introduction of direct payments in Croatia In Croatia, direct payments shall be introduced in accordance with the following schedule of increments expressed as a percentage of the corresponding level of the direct payments as applied from 2022: 25 % in 2013, 30 % in 2014, 35 % in 2015, 40 % in 2016, 50 % in 2017, 60 % in 2018, 70 % in 2019, 80 % in 2020, 90 % in 2021, 100 % from 2022. Article 18 Complementary national direct payments and direct payments in Bulgaria and Romania 1. In 2015, Bulgaria and Romania may use national direct payments in order to complement payments granted under the basic payment scheme referred to in Sections 1, 2 and 3 of Chapter 1 of Title III. The total amount of those payments shall not exceed the relevant amount set out in point B of Annex V. 2. In 2015, Bulgaria may use national direct payments in order to complement payments granted under the crop-specific payment for cotton referred to in Chapter 2 of Title IV. The total amount of those payments shall not exceed the amount set out in point C of Annex V. 3. Complementary national direct payments shall be granted in accordance with objective criteria and in such a way as to ensure the equal treatment of farmers and to avoid distortions of the market and of competition. Article 19 Complementary national direct payments for Croatia 1. Subject to authorisation by the Commission, Croatia may complement any of the support schemes listed in Annex I, where relevant. 2. The amount of complementary national direct payments which may be granted in a given year and for a given support scheme shall be limited by a specific financial envelope. This envelope shall be established as the difference between: (a) the amount of direct support available per support scheme concerned after the full introduction of direct payments in accordance with Article 17 for the calendar year 2022, and (b) the amount of direct support available per support scheme concerned after the application of the schedule of increments in accordance with Article 17 for the calendar year concerned. 3. The total amount of complementary national direct payments granted shall not be higher than the ceiling set out in point B of Annex VI for a corresponding calendar year. 4. Croatia may decide, on the basis of objective criteria and after authorisation by the Commission, on the amounts of complementary national direct payments to be granted. 5. The Commission shall adopt implementing acts authorising the payments under this Article, specifying the relevant support schemes and defining the level up to which the complementary national direct payments may be paid. As regards complementary national direct payments intended to complement the voluntary coupled support referred to in Chapter 1 of Title IV, the implementing acts shall also specify the specific types of farming or the specific agricultural sectors referred to in Article 52(3) to which the complementary national direct payments may relate. Those implementing acts shall be adopted without applying the procedure referred to in Article 71(2) or (3). 6. The eligibility conditions for complementary national direct payments for Croatia shall be identical to those for support under corresponding support schemes as laid down in this Regulation. 7. Complementary national direct payments for Croatia shall be subject to any adjustments which may be rendered necessary by developments in the CAP. They shall be granted in accordance with objective criteria and in such a way as to ensure equal treatment between farmers and to avoid distortions of the market and of competition. 8. Croatia shall submit a report providing information on the measures for the implementation of the complementary national direct payments by 30 June of the year following their implementation. The report shall cover at least the following: (a) any changes in the situation affecting the complementary national direct payments; (b) for each complementary national direct payment, the numbers of beneficiaries and the total amount of complementary national direct payment granted, as well as the hectares and the number of animals or other units for which that complementary national direct payment has been granted; (c) a report on control measures applied in relation to the complementary national direct payments granted. Article 20 Special national de-mining reserve for Croatia 1. From 2015 onwards, Croatia shall notify the Commission by 31 January of each year of the areas which have been identified in accordance with Article 57a(10) of Regulation (EC) No 73/2009 and which were returned to use for agricultural activities in the previous calendar year. Croatia shall also notify the Commission of the number of payment entitlements available to farmers on 31 December of the previous calendar year, as well as the amount remained unspent in the special national de-mining reserve on that same date. Where applicable, the notifications provided in the first and second subparagraphs shall be made per region as defined in accordance with Article 23(1) of this Regulation. 2. When adapting Annex II pursuant to Article 6(3), the Commission shall calculate on a yearly basis the amount to be added to the amounts set for Croatia in that Annex in order to finance the support to be granted under the schemes listed in Annex I for the areas referred to in paragraph 1 of this Article. This amount shall be calculated on the basis of the data notified by Croatia in accordance with paragraph 1 of this Article and the estimated average direct payments per hectare in Croatia for the year concerned. The maximum amount to be added in accordance with the first subparagraph, on the basis of all the areas notified by Croatia in accordance with paragraph 1 of this Article until 2022, shall be EUR 9 600 000 and shall be subject to the schedule of introduction of direct payments in accordance with Article 17. The resulting maximum annual amounts are set out in Annex VII. 3. The Commission shall adopt implementing acts setting the share of the amount to be added in accordance with paragraph 2 which Croatia shall include in the special national de-mining reserve in order to allocate payment entitlements for the areas referred to in paragraph 1. That share shall be calculated on the basis of the ratio between the ceiling for the basic payment scheme and the national ceiling set out in Annex II before the national ceiling's increase in accordance with paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). 4. For the years 2015 to 2022, Croatia shall use the special national de-mining reserve to allocate payment entitlements to farmers on the basis of de-mined land declared by the farmers in the year in question where: (a) such land consists of eligible hectares within the meaning of Article 32(2) to (5); (b) the land in question was returned to use for agricultural activities during the previous calendar year; and (c) the land has been notified to the Commission in accordance with paragraph 1 of this Article. 5. The value of the payment entitlements established under this Article shall be the national or regional average value of payment entitlements in the year of allocation within the limits of the amount available in the special national de-mining reserve. 6. In order to take account of the consequences of the return of de-mined land to use for agricultural activities as notified by Croatia in accordance with this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 adapting the amounts set out in Annex VI. TITLE III BASIC PAYMENT SCHEME, SINGLE AREA PAYMENT SCHEME AND RELATED PAYMENTS CHAPTER 1 Basic payment scheme and single area payment scheme Section 1 Setting up of the basic payment scheme Article 21 Payment entitlements 1. Support under the basic payment scheme shall be available to farmers: (a) who obtain payment entitlements under this Regulation through allocation pursuant to Article 20(4), through first allocation pursuant to Article 24 or Article 39, through allocation from the national reserve or regional reserves pursuant to Article 30 or through transfer pursuant to Article 34; or (b) who comply with Article 9 and hold owned or leased-in payment entitlements in a Member State which has decided, in accordance with paragraph 3, to keep its existing payment entitlements. 2. Payment entitlements obtained under the single payment scheme in accordance with Regulation (EC) No 1782/2003 and with Regulation (EC) No 73/2009 shall expire on 31 December 2014. 3. By way of derogation from paragraph 2, Member States which established the single payment scheme in accordance with Section I of Chapter 5 of Title III or Chapter 6 of Title III of Regulation (EC) No 1782/2003 or Chapter 3 of Title III of Regulation (EC) No 73/2009 may, by 1 August 2014, decide to keep the existing payment entitlements. They shall notify any such decision to the Commission by that date. 4. As regards Member States which take the decision referred to in paragraph 3, when the number of owned or leased-in payment entitlements established in accordance with Regulation (EC) No 1782/2003 and with Regulation (EC) No 73/2009 which a farmer holds on the final date for submission of applications to be set in accordance with point (b) of the first subparagraph of Article 78 of Regulation (EU) No 1306/2013 exceeds the number of eligible hectares which the farmer declares in his aid application in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 for 2015, and which are at his disposal on a date fixed by the Member State, which shall be no later than the date fixed in that Member State for amending such an aid application, the number of payment entitlements exceeding the number of eligible hectares shall expire on the latter date. Article 22 Basic payment scheme ceiling 1. The Commission shall adopt implementing acts setting, for each Member State, the annual national ceiling for the basic payment scheme by deducting from the annual national ceiling set out in Annex II the ceilings fixed in accordance with Articles 42, 47, 49, 51 and 53. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). 2. For each Member State, the amount calculated in accordance with the paragraph 1 of this Article may be increased by a maximum of 3 % of the relevant annual national ceiling set out in Annex II after deduction of the amount resulting from the application of Article 47(1) for the relevant year. When a Member State applies such an increase, that increase shall be taken into account by the Commission when setting the annual national ceiling for the basic payment scheme pursuant to paragraph 1 of this Article. For that purpose, Member States shall notify the Commission by 1 August 2014 of the annual percentages by which the amount calculated pursuant to paragraph 1 of this Article is to be increased. 3. Member States may review their decision referred to in paragraph 2 on an annual basis and shall notify the Commission of any decision based on such review by 1 August of the year preceding its application. 4. For each Member State and each year, the total value of all payment entitlements and the national reserve or the regional reserves shall equal the respective annual national ceiling set by the Commission pursuant to paragraph 1. 5. If the ceiling for a Member State set by the Commission pursuant to paragraph 1 is different from that of the previous year as a result of any decision taken by that Member State in accordance with paragraph 3 of this Article, the third and fourth subparagraphs of Article 14(1), the third and fourth subparagraphs of Article 14(2), Article 42(1), the second subparagraph of Article 49(1), the second subparagraph of Article 51(1), or Article 53, that Member State shall linearly reduce or increase the value of all payment entitlements in order to ensure compliance with paragraph 4 of this Article. Article 23 Regional allocation of the national ceilings 1. Member States may decide, by 1 August 2014, to apply the basic payment scheme at regional level. In such cases, they shall define the regions in accordance with objective and non-discriminatory criteria such as their agronomic and socio-economic characteristics, their regional agricultural potential, or their institutional or administrative structure. Member States applying Article 36 may take the decision referred to in the first subparagraph by 1 August of the year preceding the first year of implementation of the basic payment scheme. 2. Member States shall divide the annual national ceiling for the basic payment scheme referred to in Article 22(1) between the regions in accordance with objective and non-discriminatory criteria. Member States not applying Article 30(2) shall make that division after applying the linear reduction provided for in Article 30(1). 3. Member States may decide that the regional ceilings shall be subject to annual progressive modifications in accordance with pre-established annual steps and objective and non-discriminatory criteria such as agricultural potential or environmental criteria. 4. To the extent necessary to respect the applicable regional ceilings determined in accordance with paragraph 2 or 3, Member States shall make a linear reduction or increase in the value of the payment entitlements in each of the relevant regions. 5. Member States applying paragraph 1 may decide to cease the application of the basic payment scheme at regional level from a date to be set by them. 6. Member States applying the first subparagraph of paragraph 1 shall notify the Commission of the decision referred to in that subparagraph and of the measures taken for the application of paragraphs 2 and 3 by 1 August 2014. Member States applying the second subparagraph of paragraph 1 shall notify the Commission of any decision referred to in that subparagraph and of the measures taken for the application of paragraphs 2 and 3 by 1 August of the relevant year. Member States applying paragraph 1 shall notify the Commission of any decision referred to in paragraph 5 by 1 August of the year preceding the first year of implementation of that decision. Article 24 First allocation of payment entitlements 1. Payment entitlements shall be allocated to farmers who are entitled to be granted direct payments in accordance with Article 9 of this Regulation provided that: (a) they apply for allocation of payment entitlements under the basic payment scheme by the final date for submission of applications in 2015 to be set in accordance with point (b) of the first subparagraph of Article 78 of Regulation (EU) No 1306/2013, except in case of force majeure or exceptional circumstances; and (b) they were entitled to receive payments, before any reduction or exclusion provided for in Chapter 4 of Title II of Regulation (EC) No 73/2009, in respect of an aid application for direct payments, for transitional national aid or for complementary national direct payments in accordance with Regulation (EC) No 73/2009 for 2013. The first subparagraph shall not apply in Member States applying Article 21(3) of this Regulation. Member States may allocate payment entitlements to farmers who are entitled to be granted direct payments in accordance with Article 9 of this Regulation, who fulfil the condition provided for in point (a) of the first subparagraph and who: (a) did not receive payments for 2013 in respect of an aid application as referred to in the first subparagraph of this paragraph and who, on the date fixed by the Member State concerned in accordance with Article 11(2) of Commission Regulation (EC) No 1122/2009 (22) for the claim year 2013: (i) in Member States applying the single payment scheme: \u2014 were producing fruits, vegetables, ware potatoes, seed potatoes or ornamental plants, and did so on a minimum area expressed in hectares if the Member State concerned decides to adopt such a requirement, or \u2014 were cultivating vineyards; or (ii) in Member States applying the single area payment scheme, had only agricultural land that was not in good agricultural condition on 30 June 2003 as provided for in Article 124(1) of Regulation (EC) No 73/2009; (b) in 2014, are allocated payment entitlements from the national reserve under the single payment scheme pursuant to Article 41 or 57 of Regulation (EC) No 73/2009; or (c) never held owned or leased-in payment entitlements established under Regulation (EC) No 73/2009 or Regulation (EC) No 1782/2003 and who submit verifiable evidence that, on the date fixed by the Member State in accordance with Article 11(2) of Regulation (EC) No 1122/2009 for the claim year 2013, they produced, reared or grew agricultural products, including through harvesting, milking, breeding animals and keeping animals for farming purposes. Member States may establish their own additional objective and non-discriminatory eligibility criteria for this category of farmers as regards appropriate skills, experience or education. 2. Except in the case of force majeure or exceptional circumstances, the number of payment entitlements allocated per farmer in 2015 shall be equal to the number of eligible hectares, which the farmer declares in his aid application in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 for 2015 and which are at his disposal on a date fixed by the Member State. That date shall be no later than the date fixed in that Member State for amending such an aid application. 3. Member States may apply one or more of the limitations, as set out in paragraphs 4 to 7, on the number of payment entitlements to be allocated under paragraph 2. 4. Member States may decide that the number of payment entitlements to be allocated shall be equal to either the number of eligible hectares which the farmer declared in accordance with Article 34(2) of Regulation (EC) No 73/2009 in 2013, or the number of eligible hectares referred to in paragraph 2 of this Article, whichever is the lowest. For Croatia, the use of this option shall be without prejudice to the allocation of payment entitlements for de\u2013mined hectares in accordance with Article 20(4) of this Regulation. 5. Where the total number of eligible hectares referred to in paragraph 2 of this Article declared in a Member State would result in an increase of more than 35 % of the total number of eligible hectares declared in accordance with Article 35 of Regulation (EC) No 73/2009 in 2009, or in the case of Croatia in 2013, Member States may limit the number of payment entitlements to be allocated in 2015 to a minimum of either 135 % or 145 % of the total number of eligible hectares declared in 2009, or, in the case of Croatia, of the total number of eligible hectares declared in 2013, in accordance with Article 35 of Regulation (EC) No 73/2009. When using this option, Member States shall allocate a reduced number of payment entitlements to farmers. That number shall be calculated by applying a proportional reduction to the additional number of eligible hectares declared by each farmer in 2015 compared to the number of eligible hectares within the meaning of Article 34(2) of Regulation (EC) No 73/2009 that that farmer declared in his aid application in 2011 or, in the case of Croatia, in 2013, without prejudice to the de-mined hectares for which payment entitlements are to be allocated in accordance with Article 20(4) of this Regulation. 6. Member States may decide to apply, for the purposes of establishing the number of payment entitlements to be allocated to a farmer, a reduction coefficient to those eligible hectares referred to in paragraph 2 which consist of permanent grassland located in areas with difficult climate conditions, especially due to their altitude and other natural constraints such as poor soil quality, steepness and water supply. 7. Member States may decide that the number of payment entitlements to be allocated to a farmer shall be equal to the number of eligible hectares referred to in paragraph 2 of this Article which were not hectares of vineyards on the date fixed by the Member State in accordance with Article 11(2) of Regulation (EC) No 1122/2009 for the claim year 2013 or hectares of arable land under permanent greenhouses. 8. In the case of the sale or lease of their holding or part of it, natural or legal persons complying with paragraph 1 of this Article may, by contract signed before the final date for submitting applications in 2015 to be set in accordance with point (b) of the first subparagraph of Article 78 of Regulation (EU) No 1306/2013, transfer the right to receive payment entitlements in accordance with paragraph 1 of this Article to one or more farmers provided that the latter comply with the conditions laid down in Article 9 of this Regulation. 9. A Member State may decide to fix a minimum size per holding, expressed in eligible hectares, in respect of which the farmer may apply for an allocation of payment entitlements. That minimum size shall not exceed the threshold set out in point (b) of Article 10(1) in conjunction with paragraph 2 of that Article. 10. Member States shall, where relevant, notify the Commission of the decisions referred to in this Article by 1 August 2014. 11. The Commission shall adopt implementing acts laying down rules on applications for the allocation of payment entitlements submitted in the year of allocation of payment entitlements where those payment entitlements may not yet be definitively established and where that allocation is affected by specific circumstances. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 25 Value of payment entitlements and convergence 1. In 2015, Member States shall calculate the unit value of payment entitlements by dividing a fixed percentage of the national ceiling set out in Annex II for each relevant year by the number of payment entitlements in 2015 at national or regional level, excluding those allocated from the national reserve or regional reserves in 2015. The fixed percentage referred to in the first subparagraph shall be calculated by dividing the national or regional ceiling for the basic payment scheme to be set in accordance with, respectively, Article 22(1) or Article 23(2) of this Regulation for 2015, after applying the linear reduction provided for in paragraph 1 or, where applicable, paragraph 2 of Article 30, by the national ceiling for 2015 set out in Annex II. The payment entitlements shall be expressed in a number that corresponds to a number of hectares. 2. By way of derogation from the calculation method referred to in paragraph 1, Member States may decide to differentiate the value of payment entitlements in 2015, excluding those allocated from the national reserve or regional reserves in 2015, for each relevant year on the basis of their initial unit value as calculated in accordance with Article 26. 3. From claim year 2019 at the latest, all payment entitlements in a Member State or, where Article 23 is applied, in a region shall have a uniform unit value. 4. By way of derogation from paragraph 3, a Member State may decide that payment entitlements with an initial unit value as calculated in accordance with Article 26 that is lower than 90 % of the national or regional unit value in 2019 shall, for claim year 2019 at the latest, have their unit value increased by at least one third of the difference between their initial unit value and 90 % of the national or regional unit value in 2019. Member States may decide to set the percentage referred to in the first subparagraph at a level higher than 90 % but not above 100 %. In addition, Member States shall provide that, at the latest for claim year 2019, no payment entitlement shall have a unit value lower than 60 % of the national or regional unit value in 2019, unless this would, in Member States applying the threshold referred to in paragraph 7, result in a maximum decrease exceeding that threshold. In such cases, the minimum unit value shall be set at a level necessary to respect that threshold. 5. The national or regional unit value in 2019 referred to in the paragraph 4 shall be calculated by dividing a fixed percentage of the national ceiling set out in Annex II, or of the regional ceiling, for calendar year 2019 by the number of payment entitlements in 2015 in the Member State or region concerned, excluding those allocated from the national reserve or regional reserves in 2015. That fixed percentage shall be calculated by dividing the national or regional ceiling for the basic payment scheme to be set in accordance with, respectively, Article 22(1) or Article 23(2) for the year 2015, after applying the linear reduction provided for in paragraph 1 or, where applicable, paragraph 2 of Article 30, by the national ceiling set out in Annex II, or the regional ceiling, for 2015. 6. The regional ceilings referred to in the paragraph 5 shall be calculated by applying a fixed percentage to the national ceiling set out in Annex II for the year 2019. That fixed percentage shall be calculated by dividing the respective regional ceilings established in accordance with Article 23(2) for the year 2015 by the national ceiling to be set in accordance with Article 22(1) for the year 2015, after applying the linear reduction provided for in Article 30(1) where the second subparagraph of Article 23(2) applies. 7. In order to finance the increases in the value of payment entitlements referred to in paragraph 4, where payment entitlements have an initial unit value higher than the national or regional unit value in 2019, the difference between their initial unit value and the national or regional unit value in 2019 shall be decreased on the basis of objective and non-discriminative criteria to be determined by Member States. Such criteria may include the fixing of a maximum decrease of the initial unit value of 30 %. 8. When applying paragraph 2 of this Article, the transition from the initial unit value of payment entitlements as calculated in accordance with Article 26 to their final unit value in 2019 as established in accordance with paragraph 3 or paragraphs 4 to 7 of this Article shall be made in equal steps starting from 2015. In order to ensure compliance with the fixed percentage referred to in paragraph 1 of this Article for each year, the value of the payment entitlements with an initial unit value that is higher than the national or regional unit value in 2019 shall be adjusted. 9. By way of derogation from paragraph 8 of this Article, where Member States which, in accordance with Article 21(3), decide to keep their existing entitlements apply paragraph 2 of this Article, the transition from the initial unit value of payment entitlements as established in accordance with Article 26(5) to their final unit value in 2019 as established in accordance with paragraph 3 or paragraphs 4 to 7 of this Article shall, where applicable, be made by applying the steps decided nationally in accordance with Article 63(3) of Regulation (EC) No 1782/2003. In order to ensure compliance with the fixed percentage referred to in paragraph 1 of this Article for each year, the value of all payment entitlements shall be linearly adjusted. 10. In 2015, Member States shall inform farmers of the value of their payment entitlements as calculated in accordance with this Article and Articles 26 and 27 for each year of the period covered by this Regulation. Article 26 Calculation of the initial unit value 1. The initial unit value of payment entitlements referred to in Article 25(2) in Member States which apply the single payment scheme in calendar year 2014 and which have not decided to keep their existing payment entitlements in accordance with Article 21(3) shall be set in accordance with either of the methods set out in paragraphs 2 or 3. 2. A fixed percentage of the payments the farmer received for 2014 under the single payment scheme, in accordance with Regulation (EC) No 73/2009, before reductions and exclusions provided for in Chapter 4 of Title II of that Regulation, shall be divided by the number of payment entitlements he is allocated in 2015, excluding those allocated from the national reserve or regional reserves in 2015. That fixed percentage shall be calculated by dividing the national or regional ceiling for the basic payment scheme to be set in accordance with, respectively, Article 22(1) or Article 23(2) of this Regulation for the year 2015, after applying the linear reduction provided for in paragraph 1 or, where applicable, paragraph 2 of Article 30 of this Regulation, by the amount of the payments for 2014 under the single payment scheme in the Member State or region concerned, before reductions and exclusions provided for in Chapter 4 of Title II of Regulation (EC) No 73/2009. 3. A fixed percentage of the value of the entitlements, including special entitlements, which the farmer held on the date of submission of his application for 2014 under the single payment scheme, in accordance with Regulation (EC) No 73/2009, shall be divided by the number of payment entitlements he is allocated in 2015, excluding those allocated from the national reserve or regional reserves in 2015. That fixed percentage shall be calculated by dividing the national or regional ceiling for the basic payment scheme to be set in accordance with, respectively, Article 22(1) or Article 23(2) of this Regulation for the year 2015, after applying the linear reduction provided for in paragraph 1 or, where applicable, paragraph 2 of Article 30 of this Regulation, by the total value of all entitlements, including special entitlements, in the Member State or region concerned for 2014, under the single payment scheme. For the purpose of this paragraph, a farmer shall be considered to hold payment entitlements on the date of submission of his application for 2014 where payment entitlements were allocated or definitively transferred to him by that date. 4. Member States which apply the single area payment scheme in calendar year 2014 shall calculate the initial unit value of payment entitlements referred to in Article 25(2) of this Regulation by dividing a fixed percentage of the total value of aid the farmer received for 2014 under the single area payment scheme in accordance with Regulation (EC) No 73/2009 and under Articles 132 and 133a of that Regulation, before reductions and exclusions provided for in Chapter 4 of Title II of that Regulation, by the number of payment entitlements he is allocated in 2015, excluding those allocated from the national reserve or regional reserves in 2015. That fixed percentage shall be calculated by dividing the national or regional ceiling for the basic payment scheme to be set in accordance with, respectively, Article 22(1) or Article 23(2) of this Regulation for the year 2015, after applying the linear reduction provided for in paragraph 1 or, where applicable, paragraph 2 of Article 30 of this Regulation, by the total value of aid granted under the single area payment scheme in accordance with Regulation (EC) No 73/2009 and under Articles 132 and 133a of that Regulation for 2014 in the Member State or region concerned, before reductions and exclusions provided for in Chapter 4 of Title II of that Regulation. 5. Member States which apply the single payment scheme in calendar year 2014 and which, in accordance with Article 21(3) of this Regulation, decide to keep their existing payment entitlements shall calculate the initial unit value of payment entitlements referred to in Article 25(2) of this Regulation by multiplying the unit value of the entitlements by a fixed percentage. That fixed percentage shall be calculated by dividing the national or regional ceiling for the basic payment scheme to be set in accordance with, respectively, Article 22(1) or Article 23(2) of this Regulation for the year 2015, after applying the linear reduction provided for in paragraph 1 or, where applicable, paragraph 2 of Article 30 of this Regulation, by the amount of the payments for 2014 under the single payment scheme in the Member State or region concerned, before reductions and exclusions provided for in Chapter 4 of Title II of Regulation (EC) No 73/2009. 6. For the purposes of calculation methods provided for in this Article, provided that the relevant sectors do not receive any voluntary coupled support pursuant to Title IV of this Regulation, Member States may also take into account the support granted for calendar year 2014 under one or more of the schemes pursuant to Article 52, Article 53(1) and points (a) and (b) of Article 68(1) of Regulation (EC) No 73/2009 and, as regards Member States which applied the single area payment scheme in accordance with Regulation (EC) No 73/2009, pursuant to point (c) of Article 68(1) and Articles 126, 127 and 129 of that Regulation. Member States which decide to apply the voluntary coupled support pursuant to Title IV of this Regulation may take into account the differences between the level of support granted in calendar year 2014 and the level of support to be granted in accordance with Title IV of this Regulation when applying a calculation method provided for in this Article, provided that: (a) the voluntary coupled support pursuant to Title IV of this Regulation is granted to a sector which was granted support in calendar year 2014 pursuant to Article 52, Article 53(1) and points (a) and (b) of Article 68(1) and, for Member States which applied the single area payment scheme, pursuant to point (c) of Article 68(1) and Articles 126, 127 and 129 of Regulation (EC) No 73/2009; and (b) the amount per unit of the voluntary coupled support is lower than the amount per unit of the support in 2014. Article 27 Inclusion of the special national de-mining reserve For Croatia, any reference in Articles 25 and 26 to the national reserve shall be read as including the special national de-mining reserve referred to in Article 20. In addition, the amount arising from the special national de-mining reserve shall be deducted from the ceilings of the basic payment scheme referred to in the second subparagraph of Article 25(1), in paragraphs 5 and 6 of that Article and in Article 26. Article 28 Windfall profit For the purposes of Article 25(4) to (7) and Article 26, a Member State may, on the basis of objective criteria, provide that, in cases of sale or grant or expiry of all or part of a lease of agricultural areas after the date fixed pursuant to Article 35 or Article 124(2) of Regulation (EC) No 73/2009 and before the date fixed pursuant to Article 33(1) of this Regulation, the increase, or part of the increase, in the value of payment entitlements that would be allocated to the farmer concerned is to revert to the national reserve or regional reserves where the increase would lead to a windfall profit for the farmer concerned. Those objective criteria shall be established in such a way as to ensure the equal treatment of farmers and to avoid distortions of the market and of competition and shall include, at least, the following: (a) a minimum duration for the lease; and (b) the proportion of the payment received which shall revert to the national reserve or regional reserves. Article 29 Notifications concerning the value of payment entitlements and convergence Member States shall notify the Commission of any decision referred to in Articles 25, 26 and 28 by 1 August 2014. Section 2 National reserve and regional reserves Article 30 Establishment and use of the national reserve or regional reserves 1. Each Member State shall establish a national reserve. In order to do so, Member States shall proceed, in the first year of implementation of the basic payment scheme, to a linear percentage reduction of the basic payment scheme ceiling at national level. 2. By way of derogation from paragraph 1, Member States exercising the option in Article 23(1) may establish regional reserves. In order to do so, Member States shall proceed, in the first year of implementation of the basic payment scheme, to a linear percentage reduction of the relevant basic payment scheme ceiling at regional level referred to in the first subparagraph of Article 23(2). 3. The reduction referred to in paragraphs 1 and 2 shall not be higher than 3 %, unless a higher percentage is required to cover any allocation needs pursuant to paragraph 6 or to points (a) and (b) of paragraph 7 for the year 2015 or, for Member States applying Article 36, for the first year of implementation of the basic payment scheme. 4. Member States shall allocate payment entitlements from their national or regional reserves in accordance with objective criteria and in such a way as to ensure the equal treatment of farmers and to avoid distortions of the market and of competition. 5. Payment entitlements referred to in paragraph 4 shall only be allocated to farmers entitled to be granted direct payments in accordance with Article 9. 6. Member States shall use their national or regional reserves to allocate payment entitlements, as a matter of priority, to young farmers and to farmers commencing their agricultural activity. 7. Member States may use their national or regional reserves to: (a) allocate payment entitlements to farmers in order to prevent land from being abandoned, including in areas subject to restructuring or development programmes relating to a form of public intervention; (b) allocate payment entitlements to farmers in order to compensate them for specific disadvantages; (c) allocate payment entitlements to farmers who were prevented from being allocated payment entitlements under this Chapter as a result of force majeure or exceptional circumstances; (d) allocate, in cases where they apply Article 21(3) of this Regulation, payment entitlements to farmers whose number of eligible hectares that they declared in 2015 in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 and that are at their disposal on a date fixed by the Member State, which shall be no later than the date fixed in that Member State for amending such an aid application, is higher than the number of owned or leased-in payment entitlements established in accordance with Regulation (EC) No 1782/2003 and with Regulation (EC) No 73/2009 that they hold on the final date for submission of applications to be set in accordance with point (b) of the first subparagraph of Article 78 of Regulation (EU) No 1306/2013; (e) linearly increase, on a permanent basis, the value of all payment entitlements under the basic payment scheme at national or regional level if the relevant national or regional reserve exceeds 0,5 % of the annual national or regional ceiling for the basic payment scheme, provided that sufficient amounts remain available for allocations under paragraph 6, under points (a) and (b) of this paragraph and under paragraph 9 of this Article; (f) cover the yearly needs for payments to be granted in accordance with Article 51(2) and Article 65(1), (2) and (3) of this Regulation. For the purpose of this paragraph, Member States shall decide on the priorities between the different uses referred to herein. 8. When applying paragraph 6 and points (a), (b) and (d) of paragraph 7, Member States shall fix the value of payment entitlements allocated to farmers at the national or regional average value of payment entitlements in the year of allocation. The national or regional average value shall be calculated by dividing the national or regional ceiling for the basic payment scheme set in accordance with, respectively, Article 22(1) or Article 23(2) for the year of allocation, excluding the amount of the national reserve or regional reserves and, in the case of Croatia, the special de-mining reserve, by the number of allocated payment entitlements. Member States shall fix the steps for annual progressive modifications of the value of payment entitlements allocated from the national reserve or regional reserves, taking account of the modifications of the national or regional ceiling for the basic payment scheme set in accordance with, respectively, Article 22(1) and Article 23(2) that result from the variations in the level of the national ceilings set out in Annex II. 9. Where a farmer is entitled to receive payment entitlements or to increase the value of the existing ones by virtue of a definitive court ruling or by virtue of a definitive administrative act of the competent authority of a Member State, the farmer shall receive the number and value of payment entitlements established in that ruling or act at a date to be fixed by the Member State. However, that date shall not be later than the latest date for lodging an application under the basic payment scheme following the date of the court ruling or the administrative act, taking into account the application of Articles 32 and 33. 10. When applying paragraph 6, points (a) and (b) of paragraph 7 and paragraph 9, Member States may either allocate new entitlements or increase the unit value of all of the existing entitlements of a farmer up to the national or regional average value. 11. For the purposes of this Article, the following definitions shall apply: (a) 'young farmers' means farmers fulfilling the conditions laid down in Article 50(2) and, where relevant, the conditions referred to in Article 50(3) and (11); (b) 'farmers commencing their agricultural activity' means natural or legal persons who, in the five years preceding the start of the agricultural activity, did not have any agricultural activity in their own name and at their own risk or did not have the control of a legal person exercising an agricultural activity. In the case of a legal person, the natural person or persons in control of the legal person must not have had any agricultural activity in their own name and at their own risk or must not have had the control of a legal person exercising an agricultural activity in the five years preceding the start of the agricultural activity by the legal person; Member States may establish their own additional objective and non-discriminative eligibility criteria for this category of farmers as regards appropriate skills, experience or education. Article 31 Replenishment of the national reserve or regional reserves 1. The national reserve or regional reserves shall be replenished by amounts resulting from: (a) payment entitlements not giving right to payments during two consecutive years due to the application of: (i) Article 9, (ii) Article 10(1), or (iii) Article 11(4) of this Regulation; (b) a number of payment entitlements equivalent to the total number of payment entitlements which have not been activated by farmers in accordance with Article 32 of this Regulation for a period of two consecutive years, except where their activation has been prevented by force majeure or exceptional circumstances; when establishing the owned or leased-in payment entitlements held by a farmer that shall revert to the national reserve or regional reserves, priority shall be given to those entitlements which have the lowest value; (c) payment entitlements voluntarily returned by farmers; (d) the application of Article 28 of this Regulation; (e) unduly allocated payment entitlements in accordance with Article 63 of Regulation (EU) No 1306/2013; (f) a linear reduction of the value of payment entitlements under the basic payment scheme at national or regional level where the national reserve or regional reserves are not sufficient to cover the cases referred to in Article 30(9) of this Regulation; (g) where Member States consider it necessary, a linear reduction of the value of payment entitlements under the basic payment scheme at national or regional level to cover cases referred to in Article 30(6) of this Regulation; (h) the application of Article 34(4) of this Regulation. 2. The Commission shall adopt implementing acts laying down necessary measures regarding the reversion of non-activated payment entitlements to the national reserve or regional reserves. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Section 3 Implementation of the basic payment scheme Article 32 Activation of payment entitlements 1. Support under the basic payment scheme shall be granted to farmers, by means of declaration in accordance with Article 33(1), upon activation of a payment entitlement per eligible hectare in the Member State where it has been allocated. Activated payment entitlements shall give a right to the annual payment of the amounts fixed therein, without prejudice to the application of financial discipline, of reduction of payments in accordance with Article 11 and of linear reductions in accordance with Article 7, Article 51(2) and point (c) of Article 65(2) of this Regulation, and to the application of Article 63 of Regulation (EU) No 1306/2013. 2. For the purposes of this Title, 'eligible hectare' means: (a) any agricultural area of the holding, including areas that were not in good agricultural condition on 30 June 2003 in Member States acceding to the Union on 1 May 2004 that opted upon accession to apply the single area payment scheme, that is used for an agricultural activity or, where the area is also used for non-agricultural activities, is predominantly used for agricultural activities; or (b) any area which gave a right to payments in 2008 under the single payment scheme or the single area payment scheme laid down, respectively, in Titles III and IVA of Regulation (EC) No 1782/2003, and which: (i) no longer complies with the definition of 'eligible hectare' under point (a) as a result of the implementation of Directive 92/43/EEC, Directive 2000/60/EC and Directive 2009/147/EC; (ii) for the duration of the relevant commitment by the individual farmer, is afforested pursuant to Article 31 of Regulation (EC) No 1257/1999 or to Article 43 of Regulation (EC) No 1698/2005 or to Article 22 of Regulation (EU) No 1305/2013 or under a national scheme the conditions of which comply with Article 43(1), (2) and (3) of Regulation (EC) No 1698/2005 or Article 22 of Regulation (EU) No 1305/2013; or (iii) for the duration of the relevant commitment of the individual farmer, is set aside pursuant to Articles 22, 23 and 24 of Regulation (EC) No 1257/1999, to Article 39 of Regulation (EC) No 1698/2005 or to Article 28 of Regulation (EU) No 1305/2013. 3. For the purposes of point (a) of paragraph 2: (a) where an agricultural area of a holding is also used for non-agricultural activities, that area shall be considered to be used predominantly for agricultural activities provided that those agricultural activities can be exercised without being significantly hampered by the intensity, nature, duration and timing of the non-agricultural activities; (b) Member States may draw up a list of areas which are predominantly used for non-agricultural activities. Member States shall establish criteria for the implementation of this paragraph on their territory. 4. Areas shall be considered to be eligible hectares only if they comply with the definition of eligible hectare throughout the calendar year, except in the case of force majeure or exceptional circumstances. 5. For the purposes of determining 'eligible hectare', Member States having taken the decision referred to in the second subparagraph of Article 4(2) may apply a reduction coefficient to convert the hectares concerned into 'eligible hectares'. 6. Areas used for the production of hemp shall only be eligible hectares if the varieties used have a tetrahydrocannabinol content not exceeding 0,2 %. Article 33 Declaration of eligible hectares 1. For the purposes of the activation of payment entitlements provided for in Article 32(1), the farmer shall declare the parcels corresponding to the eligible hectares accompanying any payment entitlement. Except in the case of force majeure or exceptional circumstances, the parcels declared shall be at the farmer's disposal on a date fixed by the Member State, which shall be no later than the date fixed in that Member State for amending the aid application as referred to in Article 72(1) of Regulation (EU) No 1306/2013. 2. Member States may, in duly justified circumstances, authorise the farmer to modify his declaration provided that he maintains at least the number of hectares corresponding to his payment entitlements and respects the conditions for granting the payment under the basic payment scheme for the area concerned. Article 34 Transfer of payment entitlements 1. Payment entitlements may be transferred only to a farmer entitled to be granted direct payments in accordance with Article 9 established in the same Member State, except in the case of transfer by actual or anticipated inheritance. Payment entitlements, including in the case of actual or anticipated inheritance, may be activated only in the Member State where they were allocated. 2. Where Member States exercise the option in Article 23(1), payment entitlements may be transferred or activated only within the same region, except in the case of actual or anticipated inheritance. Payment entitlements, including in the case of actual or anticipated inheritance, may be activated only in the region where they were allocated. 3. Member States not exercising the option in Article 23(1) may decide that payment entitlements may be transferred or activated only within the same region, except in the case of actual or anticipated inheritance. Such regions shall be defined at the appropriate territorial level in accordance with objective criteria and in a way that ensures the equal treatment of farmers and avoids distortions of the market and of competition. 4. Where payment entitlements are transferred without land, Member States may, acting in compliance with the general principles of Union law, decide that a part of the payment entitlements transferred are to revert to the national reserve or regional reserves or that their unit value is to be reduced in favour of the national reserve or regional reserves. Such reduction may be applied to one or more types of transfer. 5. The Commission shall adopt implementing acts laying down detailed rules governing the notification by farmers of transfer of payment entitlements to the national authorities and the deadlines within which such notification is to take place. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 35 Delegated powers 1. In order to ensure legal certainty and to clarify the specific situations that may arise in the application of the basic payment scheme, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 concerning: (a) rules on eligibility and access in respect of the basic payment scheme of farmers in the case of inheritance and anticipated inheritance, inheritance under a lease, change of legal status or denomination, transfer of payment entitlements, merger or scission of the holding, and the application of the contract clause referred to in Article 24(8); (b) rules on the calculation of the value and number or on the increase or reduction in the value of payment entitlements in relation to the allocation of payment entitlements under any provision of this Title, including rules: (i) on the possibility of a provisional value and number or of a provisional increase of payment entitlements allocated on the basis of the application from the farmer, (ii) on the conditions for establishing the provisional and definitive value and number of the payment entitlements, (iii) on the cases where a sale or lease contract may affect the allocation of payment entitlements; (c) rules on the establishment and calculation of the value and number of payment entitlements received from the national reserve or regional reserves; (d) rules on the modification of the unit value of payment entitlements in the case of fractions of payment entitlements and in the case of transfer of payment entitlements referred to in Article 34(4); (e) criteria for applying options under points (a), (b) and (c) of the third subparagraph of Article 24(1); (f) criteria for applying limitations on the number of payment entitlements to be allocated in accordance with Article 24(4) to (7); (g) criteria for the allocation of payment entitlements pursuant to Article 30(6) and (7); (h) criteria for setting the reduction coefficient referred to in Article 32(5). 2. In order to ensure the proper management of payment entitlements, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down rules on the content of the declaration and the requirements for the activation of payment entitlements. 3. In order to preserve public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down rules making the granting of payments conditional upon the use of certified seeds of certain hemp varieties and the procedure for the determination of hemp varieties and the verification of their tetrahydrocannabinol content referred to in Article 32(6). Section 4 Single area payment scheme Article 36 Single area payment scheme 1. Member States applying in 2014 the single area payment scheme laid down in Chapter 2 of Title V of Regulation (EC) No 73/2009 may, under the conditions set out in this Regulation, decide to continue to apply that scheme until 31 December 2020 at the latest. They shall notify the Commission of their decision and of the end date of the application of that scheme by 1 August 2014. During the period of application of the single area payment scheme, Sections 1, 2 and 3 of this Chapter shall not apply to those Member States, with the exception of the second subparagraph of Article 23(1), Article 23(6) as well as Article 32(2) to (6). 2. The single area payment shall be granted on an annual basis for each eligible hectare declared by the farmer in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013. It shall be calculated each year by dividing the annual financial envelope established in accordance with paragraph 4 of this Article by the total number of eligible hectares declared in the Member State concerned in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013. 3. By way of derogation from paragraph 2 of this Article, Member States that decide to apply Article 38 of this Regulation from 1 January 2018 at the latest may use, for the period during which they apply this Article, up to 20 % of the annual financial envelope referred to in paragraph 2 of this Article to differentiate the single area payment per hectare. When doing so, they shall take into account the support granted for calendar year 2014 under one or more of the schemes pursuant to points (a), (b) and (c) of Article 68(1) and Articles 126, 127 and 129 of Regulation (EC) No 73/2009. Cyprus may differentiate the aid taking into account the sector-specific financial envelopes set out in Annex XVIIa of Regulation (EC) No 73/2009, reduced by any aid granted to the same sector pursuant to Article 37 of this Regulation. 4. The Commission shall adopt implementing acts setting, for each Member State, the annual national ceiling for the single area payment scheme by deducting from the annual national ceiling set out in Annex II the ceilings fixed in accordance with Articles 42, 47, 49, 51 and 53. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). 5. Except in the case of force majeure or exceptional circumstances, the hectares referred to in paragraph 2 shall be at the farmer's disposal on a date fixed by the Member State, which shall be no later than the date fixed in that Member State for amendment of the aid application referred to in Article 72(1) of Regulation (EU) No 1306/2013. 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 70 concerning rules on eligibility and the access of farmers to the single area payment scheme. Article 37 Transitional national aid 1. Member States applying the single area payment scheme in accordance with Article 36 may decide to grant transitional national aid in the period 2015-2020. 2. Transitional national aid may be granted to farmers in sectors in respect of which this aid or, in the case of Bulgaria and Romania, complementary national direct payments were granted in 2013. 3. The conditions for granting transitional national aid shall be identical to those authorised for the granting of payments pursuant to Article 132(7) or Article 133a of Regulation (EC) No 73/2009 in respect of 2013, with the exception of the reduction of the payments resulting from the application of Article 132(2) in conjunction with Articles 7 and 10 of that Regulation. 4. The total amount of transitional national aid that may be granted to farmers in any of the sectors referred to in paragraph 2 shall be limited to the following percentage of the sector-specific financial envelopes authorised by the Commission in accordance with Article 132(7) or Article 133a(5) of Regulation (EC) No 73/2009 in 2013: \u2014 75 % in 2015, \u2014 70 % in 2016, \u2014 65 % in 2017, \u2014 60 % in 2018, \u2014 55 % in 2019, \u2014 50 % in 2020. For Cyprus, the percentage shall be calculated on the basis of the sector-specific financial envelopes set out in Annex XVIIa to Regulation (EC) No 73/2009. 5. Paragraphs 2 and 3 shall not apply to Cyprus. 6. Member States shall notify any decision referred to in paragraph 1 to the Commission by 31 March of each year. The notification shall include the following information: (a) the sector-specific financial envelope; (b) the maximum rate of transitional national aid, where appropriate. 7. Member States may decide, on the basis of objective criteria and within the limits set out in paragraph 4, on the amounts of transitional national aid to be granted. Section 5 Implementation of the basic payment scheme in the member states having applied the single area payment scheme Article 38 Introduction of the basic payment scheme in the Member States having applied the single area payment scheme Save as otherwise provided for in this Section, this Title shall apply to the Member States having applied the single area payment scheme provided for in Section 4 of this Chapter. Articles 24 to 29 shall not apply to those Member States. Article 39 First allocation of payment entitlements 1. Payment entitlements shall be allocated to farmers who are entitled to be granted direct payments in accordance with Article 9 of this Regulation provided that: (a) they apply for allocation of payment entitlements under the basic payment scheme by a final date for submission of applications to be set in accordance with point (b) of the first subparagraph of Article 78 of Regulation (EU) No 1306/2013 in the first year of implementation of the basic payment scheme, except in case of force majeure or exceptional circumstances; and (b) they were entitled to receive payments, before any reduction or exclusion provided for in Chapter 4 of Title II of Regulation (EC) No 73/2009, in respect of an aid application for direct payments, for transitional national aid or for complementary national direct payments in accordance with Regulation (EC) No 73/2009 for 2013. Member States may allocate payment entitlements to farmers who are entitled to be granted direct payments in accordance with Article 9 of this Regulation, who fulfil the condition provided for in point (a) of the first subparagraph, who did not receive payments for 2013 in respect of an aid application referred to in point (b) of the first subparagraph of this paragraph and who, on the date fixed by the Member State concerned in accordance with Article 11(2) of Regulation (EC) No 1122/2009 for the claim year 2013, had only agricultural land that was not in good agricultural condition on the 30 June 2003, as provided for in Article 124(1) of Regulation (EC) No 73/2009. 2. Except in the case of force majeure or exceptional circumstances, the number of payment entitlements allocated per farmer in the first year of implementation of the basic payment scheme shall be equal to the number of eligible hectares which the farmer declares in his aid application in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 for the first year of implementation of the basic payment scheme and which are at his disposal on a date fixed by the Member State. That date shall be no later than the date fixed in that Member State for amending such aid application. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down further rules on the introduction of the basic payment scheme in Member States having applied the single area payment scheme. 4. The Commission shall adopt implementing acts laying down rules on applications for the allocation of payment entitlements submitted in the year of allocation of payment entitlements where those payment entitlements may not yet be definitively established and where that allocation is affected by specific circumstances. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 40 Value of payment entitlements 1. In the first year of implementation of the basic payment scheme, Member States shall calculate the unit value of payment entitlements by dividing a fixed percentage of the national ceiling set out in Annex II for each relevant year by the number of payment entitlements in the first year of implementation of the basic payment scheme, excluding those allocated from the national reserve or regional reserves. The fixed percentage referred to in the first subparagraph shall be calculated by dividing the national or regional ceiling for the basic payment scheme to be set in accordance with, respectively, Article 22(1) or Article 23(2) of this Regulation for the first year of implementation of the basic payment scheme, after applying the linear reduction provided for in paragraph 1 or, where applicable, paragraph 2 of Article 30 by the national ceiling set out in Annex II for the first year of implementation of the basic payment scheme. The payment entitlements shall be expressed in a number that corresponds to a number of hectares. 2. By way of derogation from the calculation method referred to in paragraph 1, Member States may decide to differentiate the value of payment entitlements in the first year of implementation of the basic payment scheme, excluding those allocated from the national reserve or regional reserves for each relevant year, on the basis of their initial unit value. 3. The initial unit value of payment entitlements referred to in paragraph 2 shall be set by dividing a fixed percentage of the total value of aid, excluding aid pursuant to Articles 41, 43, 48 and 50 and Title IV of this Regulation, received by a farmer in accordance with this Regulation for the calendar year preceding the implementation of the basic payment scheme, before the application of Article 63 of Regulation (EU) No 1306/2013, by the number of payment entitlements allocated to that farmer in the first year of implementation of the basic payment scheme, excluding those allocated from the national reserve or regional reserves. That fixed percentage shall be calculated by dividing the national or regional ceiling for the basic payment scheme to be set in accordance with, respectively, Article 22(1) or Article 23(2) of this Regulation for the first year of implementation of the basic payment scheme, after applying the linear reduction provided for in paragraph 1 or, where applicable, paragraph 2 of Article 30, by the total value of aid, excluding aid pursuant to Articles 41, 43, 48 and 50 and Title IV of this Regulation, granted for the calendar year preceding the implementation of the basic payment scheme within the Member State or region concerned, before the application of Article 63 of Regulation (EU) No 1306/2013. 4. When applying paragraph 2, Member States, acting in compliance with the general principles of Union law, shall move towards approximating the value of the payment entitlements at national or regional level. To this end, Member States shall fix the steps to be taken and the method of calculation to be used and shall notify them to the Commission by 1 August of the year preceding the implementation of the basic payment scheme. Those steps shall include annual progressive modifications of the initial value of payment entitlements referred to in paragraph 3 in accordance with objective and non-discriminatory criteria, starting from the first year of implementation of the basic payment scheme. In the first year of implementation of the basic payment scheme, Member States shall inform the farmers of the value of their entitlements, calculated in accordance with this Article, for each year of the period covered by this Regulation. 5. For the purposes of paragraph 3, a Member State may, on the basis of objective criteria, provide that, in cases of sale or grant or expiry of all or part of a lease of agricultural areas after the date fixed pursuant to Article 36(5) and before the date fixed pursuant to Article 33(1), the increase, or a part thereof, in the value of payment entitlements that would be allocated to the farmer concerned is to revert to the national reserve or regional reserves where the increase would lead to a windfall profit for the farmer concerned. Those objective criteria shall be established in such a way as to ensure the equal treatment of farmers and to avoid distortions of the market and of competition and shall include, at least, the following: (a) a minimum duration for the lease; (b) the proportion of the payment received which is to revert to the national reserve or regional reserves. CHAPTER 2 Redistributive payment Article 41 General rules 1. Member States may decide by 1 August of any given year to grant, from the following year, an annual payment to farmers who are entitled to a payment under the basic payment scheme referred to in Sections 1, 2, 3 and 5 of Chapter 1 or under the single area payment scheme referred to in Section 4 of Chapter 1 (\"the redistributive payment\"). Member States shall notify the Commission of any such decision by the date referred to in the first subparagraph. 2. Member States which have decided to apply the basic payment scheme at regional level in accordance with Article 23 may apply the redistributive payment at regional level. 3. Without prejudice to the application of financial discipline, of reduction of payments in accordance with Article 11, of linear reductions as referred in Article 7 of this Regulation, and to the application of Article 63 of Regulation (EU) No 1306/2013, the redistributive payment shall be granted annually upon activation of payment entitlements by the farmer, or, in Member States applying Article 36 of this Regulation, upon declaration of eligible hectares by the farmer. 4. The redistributive payment shall be calculated each year by Member States by multiplying a figure to be set by the Member State, which shall not be higher than 65 % of the national or regional average payment per hectare, by the number of payment entitlements activated by the farmer in accordance with Article 33(1) or by the number of eligible hectares declared by the farmer in accordance with Article 36(2). The number of such payment entitlements or hectares shall not exceed a maximum to be set by Member States which shall not be higher than 30 hectares or the average size of agricultural holdings set out in Annex VIII if that average size exceeds 30 hectares in the Member State concerned. 5. Provided that the maximum limits set out in paragraph 4 are respected, Member States may, at national level, establish a graduation in the number of hectares set in accordance with that paragraph, which shall apply identically to all farmers. 6. The national average payment per hectare referred to in paragraph 4 of this Article shall be established by the Member States on the basis of the national ceiling set out in Annex II for calendar year 2019 and the number of eligible hectares declared in accordance with Article 33(1) or Article 36(2) in 2015. The regional average payment per hectare referred to in paragraph 4 of this Article shall be established by the Member States by using a share of the national ceiling set out in Annex II for calendar year 2019 and the number of eligible hectares declared in the region concerned in accordance with Article 33(1) in 2015. For each region, this share shall be calculated by dividing the respective regional ceiling set in accordance with Article 23(2) by the national ceiling set in accordance with Article 22(1), after applying the linear reduction provided for in paragraph 1 of Article 30 where paragraph 2 of that Article is not applied. 7. Member States shall ensure that no advantage provided for under this Chapter is granted to farmers in respect of whom it is established that, after 18 October 2011, they divided their holding with the sole purpose of benefiting from the redistributive payment. This shall also apply to farmers whose holdings result from that division. 8. In the case of a legal person, or a group of natural or legal persons, Member States may apply the maximum number of payment entitlements or hectares referred to in paragraph 4 at the level of the members of those legal persons or groups where national law provides for the individual members to assume rights and obligations comparable to those of individual farmers who have the status of a head of holding, in particular as regards their economic, social and tax status, provided that they have contributed to strengthening the agricultural structures of the legal persons or groups concerned. Article 42 Financial provisions 1. In order to finance the redistributive payment, Member States may decide, by the date referred to in Article 41(1), to use up to 30 % of the annual national ceiling set out in Annex II. They shall notify the Commission of any such decision by that date. 2. On the basis of the percentage of the national ceiling to be used by Member States pursuant to paragraph 1 of this Article, the Commission shall adopt implementing acts fixing the corresponding ceilings for the redistributive payment on a yearly basis. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). CHAPTER 3 Payment for agricultural practices beneficial for the climate and the environment Article 43 General rules 1. Farmers entitled to a payment under the basic payment scheme or the single area payment scheme shall observe, on all their eligible hectares within the meaning of Article 32(2) to (5), the agricultural practices beneficial for the climate and the environment referred to in paragraph 2 of this Article or the equivalent practices referred to in paragraph 3 of this Article. 2. The agricultural practices beneficial for the climate and the environment shall be the following: (a) crop diversification; (b) maintaining existing permanent grassland; and (c) having ecological focus area on the agricultural area. 3. The equivalent practices shall be those which include similar practices that yield an equivalent or higher level of benefit for the climate and the environment compared to one or several of the practices referred to in paragraph 2. Those equivalent practices and the practice or practices referred to in paragraph 2 to which they are equivalent are listed in Annex IX and shall be covered by any of the following: (a) commitments undertaken in accordance with either Article 39(2) of Regulation (EC) No 1698/2005 or Article 28(2) of Regulation (EU) No 1305/2013; (b) national or regional environmental certification schemes, including those for the certification of compliance with national environmental legislation, going beyond the relevant mandatory standards established pursuant to Chapter I of Title VI of Regulation (EU) No 1306/2013, which aim to meet objectives relating to soil and water quality, biodiversity, landscape preservation, and climate change mitigation and adaptation. Those certification schemes may include the practices listed in Annex IX to this Regulation, the practices referred to in paragraph 2 of this Article, or a combination of those practices. 4. The equivalent practices referred to in paragraph 3 shall not be the subject of double funding. 5. Member States may decide, including, where appropriate, at regional level, to restrict the choice of the farmers to use the options referred to in points (a) and (b) of paragraph 3. 6. Member States may decide, including, where appropriate, at regional level, that farmers shall carry out all of their relevant obligations under paragraph 1 in accordance with national or regional environmental certification schemes referred to in point (b) of paragraph 3. 7. Subject to the decisions of Member States referred to in paragraphs 5 and 6, a farmer may observe one or more of the practices referred to in point (a) of paragraph 3 only if these fully replace the related practice or practices referred to in paragraph 2. A farmer may use certification schemes referred to in point (b) of paragraph 3 only if these cover the entire obligation referred to in paragraph 1. 8. Member States shall notify the Commission of their decisions referred to in paragraphs 5 and 6 and of the specific commitments or certification schemes which they intend to apply as equivalent practices within the meaning of paragraph 3. The Commission shall assess whether the practices included in the specific commitments or certification schemes are covered by the list in Annex IX, and if it considers this not to be the case, notify Member States accordingly by means of implementing acts adopted without applying the procedure referred to in Article 71(2) or (3). Where the Commission notifies a Member State that those practices are not covered by the list in Annex IX, that Member State shall not recognise as equivalent practices within the meaning of paragraph 3 of this Article the specific commitments or certification schemes covered by the Commission notification. 9. Without prejudice to paragraphs 10 and 11 of this Article, to the application of financial discipline and of linear reductions in accordance with Article 7 of this Regulation and to the application of Article 63 of Regulation (EU) No 1306/2013, Member States shall grant the payment referred to in this Chapter to farmers who observe the practices referred to in paragraph 1 of this Article that are relevant for them, and to the extent that those farmers comply with Articles 44, 45 and 46 of this Regulation. This payment shall take the form of an annual payment per eligible hectare declared in accordance with Article 33(1) or Article 36(2), the amount of which shall be calculated annually by dividing the amount resulting from the application of Article 47 by the total number of eligible hectares declared in accordance with Article 33(1) or Article 36(2) in the Member State or the region concerned. By way of derogation from the second subparagraph, Member States deciding to apply Article 25(2) may decide to grant the payment referred to in this paragraph as a percentage of the total value of the payment entitlements that the farmer has activated in accordance with Article 33(1) for each relevant year. For each year and each Member State or region, that percentage shall be calculated by dividing the amount resulting from the application of Article 47 by the total value of all payment entitlements activated in accordance with Article 33(1) in that Member State or region. 10. Farmers whose holdings are fully or partly situated in areas covered by Directives 92/43/EEC, 2000/60/EC, or 2009/147/EC shall be entitled to the payment referred to in this Chapter provided that they observe the practices referred to in this Chapter to the extent that those practices are compatible in the holding concerned with the objectives of those Directives. 11. Farmers complying with the requirements laid down in Article 29(1) of Regulation (EC) No 834/2007 as regards organic farming shall be entitled ipso facto to the payment referred to in this Chapter. The first subparagraph shall apply only to the units of a holding that are used for organic production in accordance with Article 11 of Regulation (EC) No 834/2007. 12. The Commission shall be empowered to adopt delegated acts in accordance with Article 70: (a) adding equivalent practices to the list set out in Annex IX; (b) establishing appropriate requirements applicable to the national or regional certification schemes referred to in point (b) of paragraph 3 of this Article, including the level of assurance to be provided by those schemes; (c) establishing detailed rules for the calculation of the amount referred to in Article 28(6) of Regulation (EU) No 1305/2013 for the practices referred to in points 3 and 4 of Section I and point 7 of Section III of Annex IX to this Regulation, and any further equivalent practices added to that Annex pursuant to point (a) of this paragraph for which a specific calculation is needed in order to avoid double funding. 13. The Commission shall adopt implementing acts establishing rules on the procedure for the notifications, including on timetables for their submission, and the Commission assessment referred to in paragraph 8. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 44 Crop diversification 1. Where the arable land of the farmer covers between 10 and 30 hectares and is not entirely cultivated with crops under water for a significant part of the year or for a significant part of the crop cycle, there shall be at least two different crops on that arable land. The main crop shall not cover more than 75 % of that arable land. Where the arable land of the farmer covers more than 30 hectares and is not entirely cultivated with crops under water for a significant part of the year or for a significant part of the crop cycle, there shall be at least three different crops on that arable land. The main crop shall not cover more than 75 % of that arable land and the two main crops together shall not cover more than 95 % of that arable land. 2. Without prejudice to the number of crops required pursuant to paragraph 1, the maximum thresholds set out therein shall not apply to holdings where grasses or other herbaceous forage or land lying fallow cover more than 75 % of the arable land. In such cases, the main crop on the remaining arable area shall not cover more than 75 % of that remaining arable land, except where this remaining area is covered by grasses or other herbaceous forage or land lying fallow. 3. Paragraphs 1 and 2 shall not apply to holdings: (a) where more than 75 % of the arable land is used for the production of grasses or other herbaceous forage, is land lying fallow, or is subject to a combination of these uses, provided that the arable area not covered by these uses does not exceed 30 hectares; (b) where more than 75 % of the eligible agricultural area is permanent grassland, is used for the production of grasses or other herbaceous forage or for the cultivation of crops under water for a significant part of the year or for a significant part of the crop cycle, or is subject to a combination of these uses, provided that the arable area not covered by these uses does not exceed 30 hectares; (c) where more than 50 % of the areas of arable land declared were not declared by the farmer in his aid application of the previous year and, where based on a comparison of the geo-spatial aid applications, all arable land is being cultivated with a different crop compared to that of the previous calendar year; (d) that are situated in areas north of 62nd parallel or certain adjacent areas. Where the arable land of such holdings covers more than 10 hectares, there shall be at least two crops on the arable land, and none of these crops shall cover more than 75 % of the arable land, unless the main crop is grasses or other herbaceous forage, or land lying fallow. 4. For the purposes of this Article, a \"crop\" means any of the following: (a) a culture of any of the different genera defined in the botanical classification of crops; (b) a culture of any of the species in the case of Brassicaceae, Solanaceae, and Cucurbitaceae; (c) land lying fallow; (d) grasses or other herbaceous forage. Winter crop and spring crop shall be considered to be distinct crops even if they belong to the same genus. 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 70: (a) recognising other types of genera and species than those referred to in paragraph 4 of this Article; and (b) laying down the rules concerning the application of the precise calculation of shares of different crops. Article 45 Permanent grassland 1. Member States shall designate permanent grasslands which are environmentally sensitive in areas covered by Directives 92/43/EEC or 2009/147/EC, including in peat and wetlands situated in these areas, and which need strict protection in order to meet the objectives of those Directives. Member States may, in order to ensure the protection of environmentally valuable permanent grasslands, decide to designate further sensitive areas situated outside areas covered by Directives 92/43/EEC or 2009/147/EC, including permanent grasslands on carbon-rich soils. Farmers shall not convert or plough permanent grassland situated in areas designated by Member States under the first subparagraph and, where applicable, the second subparagraph. 2. Member States shall ensure that the ratio of areas of permanent grassland to the total agricultural area declared by the farmers in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 does not decrease by more than 5 % compared to a reference ratio to be established by Member States in 2015 by dividing areas of permanent grassland referred to in point (a) of the second subparagraph of this paragraph by the total agricultural area referred to in point (b) of that subparagraph. For the purposes of establishing the reference ratio referred to in the first subparagraph: (a) \"areas of permanent grassland\" means the land under permanent pasture declared in 2012, or 2013 in the case of Croatia, in accordance with Regulation (EC) No 73/2009 by the farmers subject to the obligations under this Chapter, as well as the areas of permanent grassland declared in 2015 in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 by the farmers subject to the obligations under this Chapter that have not been declared as land under permanent pasture in 2012 or, in the case of Croatia, 2013; (b) \"total agricultural area\" means the agricultural area declared in 2015 in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 by farmers subject to the obligations under this Chapter. The reference ratio of permanent grassland shall be recalculated in cases where farmers subject to the obligations under this Chapter have an obligation to reconvert an area into permanent grassland in 2015 or in 2016 in accordance with Article 93 of Regulation (EU) No 1306/2013. In such cases, these areas shall be added to the areas of permanent grassland referred to in point (a) of the second subparagraph of this paragraph. The ratio of permanent grassland shall be established each year on the basis of the areas declared by the farmers subject to the obligations under this Chapter for that year in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013. The obligation under this paragraph shall apply at national, regional or the appropriate sub-regional level. Member States may decide to apply an obligation to maintain permanent grassland at holding level in order to ensure that the ratio of permanent grassland does not decrease by more than 5 %. Member States shall notify the Commission of any such decision by 1 August 2014. Member States shall notify the reference ratio and the ratio referred to in this paragraph to the Commission. 3. Where it is established that the ratio referred to in paragraph 2 has decreased by more than 5 % at regional or sub-regional level or, where applicable, at national level, the Member State concerned shall impose obligations at holding level to reconvert land into permanent grassland for those farmers who have land at their disposal which was converted from land under permanent pasture or from permanent grassland into land for other uses during a period in the past. However, where the amount of areas of permanent grassland in absolute terms established in accordance with point (a) of the second subparagraph of paragraph 2 is maintained within certain limits, the obligation set out in the first subparagraph of paragraph 2 shall be considered to have been complied with. 4. Paragraph 3 shall not apply where the decrease below the threshold is the result of afforestation that is compatible with the environment and does not include plantations of short rotation coppice, Christmas trees or fast growing trees for energy production. 5. In order to ensure that the ratio of permanent grassland is maintained, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down detailed rules on maintenance of permanent grassland, including rules on reconversion in the case of non-respect of the obligation in paragraph 1 of this Article, rules applying to Member States for setting up obligations at holding level for maintaining permanent grassland as referred to in paragraphs 2 and 3 and any adjustment of the reference ratio referred to in paragraph 2 that may become necessary. 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 70: (a) laying down the framework for the designation of further sensitive areas referred to in the second subparagraph of paragraph 1 of this Article; (b) establishing detailed methods for the determination of the ratio of permanent grassland and of the total agricultural area that has to be maintained pursuant to paragraph 2 of this Article; (c) defining the period in the past referred to in the first subparagraph of paragraph 3 of this Article. 7. The Commission shall adopt implementing acts fixing the limits referred to in the second subparagraph of paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 46 Ecological focus area 1. Where the arable land of a holding covers more than 15 hectares, the farmer shall ensure that, from 1 January 2015, an area corresponding to at least 5 % of the arable land of the holding that the farmer declared in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 and, if they are considered to be ecological focus area by the Member State in accordance with paragraph 2 of this Article, including the areas mentioned in points (c), (d), (g) and (h) of that paragraph is ecological focus area. The percentage referred to in the first subparagraph of this paragraph shall be increased from 5 % to 7 % subject to a legislative act of the European Parliament and of the Council in accordance with Article 43(2) TFEU. By 31 March 2017, the Commission shall present an evaluation report on the implementation of the first subparagraph of this paragraph accompanied, where appropriate, by a proposal for a legislative act as referred to in the second subparagraph. 2. By 1 August 2014, Member States shall decide that one or more of the following are to be considered to be ecological focus area: (a) land lying fallow; (b) terraces; (c) landscape features, including such features adjacent to the arable land of the holding which, by way of derogation from Article 43(1) of this Regulation, may include landscape features that are not included in the eligible area in accordance with point (c) of Article 76(2) of Regulation (EU) No 1306/2013; (d) buffer strips, including buffer strips covered by permanent grassland, provided that these are distinct from adjacent eligible agricultural area; (e) hectares of agro-forestry that receive, or have received, support under Article 44 of Regulation (EC) No 1698/2005 and/or Article 23 of Regulation (EU) No 1305/2013; (f) strips of eligible hectares along forest edges; (g) areas with short rotation coppice with no use of mineral fertiliser and/or plant protection products; (h) afforested areas referred to in point (b)(ii) of Article 32(2) of this Regulation; (i) areas with catch crops, or green cover established by the planting and germination of seeds, subject to the application of weighting factors referred to in paragraph 3 of this Article; (j) areas with nitrogen-fixing crops. With the exception of the areas of the holding referred to in points (g) and (h) of the first subparagraph of this paragraph, the ecological focus area shall be located on the arable land of the holding. In the case of areas mentioned in points (c) and (d) of the first subparagraph of this paragraph, the ecological focus area may also be adjacent to the arable land of the holding the farmer declared in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013. 3. In order to simplify administration and to take account of the characteristics of the types of ecological focus area listed in the first subparagraph of paragraph 2, as well as to facilitate their measurement, Member States may, when calculating the total hectares represented by the ecological focus area of the holding, make use of the conversion and/or weighting factors set out in Annex X. If a Member State decides to consider to be ecological focus area the area under point (i) of the first subparagraph of paragraph 2 or any other area that is subject to a weighting of less than 1, the use of the weighting factors set out in Annex X shall be mandatory. 4. Paragraph 1 shall not apply to holdings: (a) where more than 75 % of the arable land is used for the production of grasses or other herbaceous forage, is land lying fallow, is used for cultivation of leguminous crops, or is subject to a combination of those uses, provided that the arable area not covered by those uses does not exceed 30 hectares; (b) where more than 75 % of the eligible agricultural area is permanent grassland, is used for the production of grasses or other herbaceous forage or for the cultivation of crops under water either for a significant part of the year or for a significant part of the crop cycle, or is subject to a combination of those uses, provided that the arable area not covered by these uses does not exceed 30 hectares. 5. Member States may decide to implement up to half of the percentage points of the ecological focus area referred to in paragraph 1 at regional level in order to obtain adjacent ecological focus areas. Member States shall designate the areas and the obligations of participating farmers or groups of farmers. The aim of the designation of areas and obligations shall be to underpin the implementation of Union policies on the environment, climate and biodiversity. 6. Member States may decide to allow farmers whose holdings are in close proximity to fulfil the obligation referred to in paragraph 1 collectively (\"collective implementation\"), provided that the ecological focus areas concerned are contiguous. In order to underpin the implementation of Union policies on the environment, climate and biodiversity, Member States may designate the areas on which collective implementation is possible and may impose further obligations upon farmers or groups of farmers participating in such collective implementation. Each farmer participating in collective implementation shall ensure that at least 50 % of the area subject to the obligation in paragraph 1 is located on the land of his holding and is in accordance with the second subparagraph of paragraph 2. The number of farmers participating in such collective implementation shall not exceed ten. 7. Member States with more than 50 % of their total land surface area covered by forest may decide that paragraph 1 of this Article shall not apply to holdings situated in areas designated by those Member States as areas facing natural constraints in accordance with point (a) or (b) of Article 32(1) of Regulation (EU) No 1305/2013, provided that more than 50 % of the land surface area of the unit referred to in the second subparagraph of this paragraph is covered by forest and the ratio of forest land to agricultural land is higher than 3:1. The area covered by forest and the ratio of forest land to agricultural land shall be assessed on an area level equivalent to the LAU2 level or on the level of another clearly delineated unit which covers a single clear contiguous geographical area having similar agricultural conditions. 8. Member States shall notify the Commission of the decisions referred to in paragraph 2 by 1 August 2014, and of any decisions referred to in paragraphs 3, 5, 6 or 7 by 1 August of the year preceding their application. 9. The Commission shall be empowered to adopt delegated acts in accordance with Article 70: (a) laying down further criteria for the types of areas referred to in paragraph 2 of this Article to qualify as ecological focus area; (b) adding other types of areas than those referred to in paragraph 2 that can be taken into account for the purpose of respecting the percentage referred to in paragraph 1; (c) adapting Annex X in order to establish the conversion and weighting factors referred to in paragraph 3 and in order to take into account the criteria and/or types of areas to be defined by the Commission under points (a) and (b) of this paragraph; (d) setting rules for the implementation referred to in paragraphs 5 and 6, including the minimum requirements on such implementation; (e) establishing the framework within which Member States are to define the criteria to be met by holdings in order to be considered to be in close proximity for the purposes of paragraph 6; (f) establishing the methods for determination of the percentage of total land surface area covered by forest and the ratio of forest land to agricultural land referred to in paragraph 7. Article 47 Financial provisions 1. In order to finance the payment referred to in this Chapter, Member States shall use 30 % of the annual national ceiling set out in Annex II. 2. Member States shall apply the payment referred to in this Chapter at national level. Member States applying Article 23 may decide to apply the payment at regional level. In such cases, they shall use in each region a share of the ceiling set pursuant to paragraph 3 of this Article. For each region, this share shall be calculated by dividing the respective regional ceiling set in accordance with Article 23(2) by the national ceiling set in accordance with Article 22(1), after applying the linear reduction provided for in paragraph 1 of Article 30 where paragraph 2 of that Article is not applied. 3. The Commission shall adopt implementing acts fixing the corresponding ceilings for the payment referred to in this Chapter on a yearly basis. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). CHAPTER 4 Payment for areas with natural constraints Article 48 General rules 1. Member States may grant a payment to farmers who are entitled to a payment under the basic payment scheme or the single area payment scheme referred to in Chapter 1 and whose holdings are fully or partly situated in areas with natural constraints designated by Member States in accordance with Article 32(1) of Regulation (EU) No 1305/2013 (\"payment for areas with natural constraints\"). 2. Member States may decide to grant the payment for areas with natural constraints to all areas falling within the scope of paragraph 1, or to restrict the payment to some of those areas on the basis of objective and non-discriminatory criteria. 3. Without prejudice to paragraph 2 of this Article, to the application of financial discipline, of reduction of payments in accordance with Article 11 and of linear reduction in accordance with Article 7 of this Regulation, and to the application of Article 63 of Regulation (EU) No 1306/2013, the payment for areas with natural constraints shall be granted annually per eligible hectare situated in the areas for which a Member State has decided to grant a payment in accordance with paragraph 2 of this Article. It shall be paid upon activation of payment entitlements in respect of those hectares held by the farmer concerned or, in Member States applying Article 36 of this Regulation, upon declaration of those eligible hectares by the farmer concerned. 4. The payment for areas with natural constraints, per hectare, shall be calculated by dividing the amount resulting from the application of Article 49 by the number of eligible hectares declared in accordance with Article 33(1) or Article 36(2) which are situated in the areas for which a Member State has decided to grant a payment in accordance with paragraph 2 of this Article. Member States may, on the basis of objective and non-discriminatory criteria, also set a maximum number of hectares per holding for which support under this Chapter can be granted. 5. Member States may apply the payment for areas with natural constraints at regional level under the conditions laid down in this paragraph provided that they identified the regions concerned in accordance with objective and non-discriminatory criteria and, in particular, their natural constraint characteristics, including the severity of the constraints, and their agronomic conditions. Member States shall divide the national ceiling referred to in Article 49(1) between the regions in accordance with objective and non-discriminatory criteria. The payment for areas with natural constraints at regional level shall be calculated by dividing the regional ceiling calculated in accordance with the second subparagraph of this paragraph by the number of eligible hectares declared in the respective region in accordance with Article 33(1) or Article 36(2) which are situated in the areas for which a Member State has decided to grant a payment in accordance with paragraph 2 of this Article. Article 49 Financial provisions 1. In order to finance the payment for areas with natural constraints, Member States may decide, by 1 August 2014, to use up to 5 % of their annual national ceiling set out in Annex II. They shall notify the Commission of any such decision by that date. Member States may, by 1 August 2016, review their decision and amend it with effect from 1 January 2017. They shall notify the Commission of any such decision by 1 August 2016. 2. On the basis of the percentage of the national ceiling to be used by Member States pursuant to paragraph 1, the Commission shall adopt implementing acts fixing the corresponding ceilings for the payment for areas with natural constraints on a yearly basis. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). CHAPTER 5 Payment for young farmers Article 50 General rules 1. Member States shall grant an annual payment to young farmers who are entitled to a payment under the basic payment scheme or the single area payment scheme referred to in Chapter 1 (\"payment for young farmers\"). 2. For the purposes of this Chapter, 'young farmers', means natural persons: (a) who are setting up for the first time an agricultural holding as head of the holding, or who have already set up such a holding during the five years preceding the first submission of an application under the basic payment scheme or the single area payment scheme referred to in Article 72(1) of Regulation (EU) No 1306/2013; and (b) who are no more than 40 years of age in the year of submission of the application referred to in point (a). 3. Member States may define further objective and non-discriminatory eligibility criteria for young farmers applying for the payment for young farmers as regards appropriate skills and/or training requirements. 4. Without prejudice to the application of financial discipline, of reduction of payments in accordance with Article 11 and of linear reductions in accordance with Article 7 of this Regulation, and to the application of Article 63 of Regulation (EU) No 1306/2013, the payment for young farmers shall be granted annually upon activation of payment entitlements by the farmer or, in Member States applying Article 36 of this Regulation, upon declaration of eligible hectares by the farmer. 5. The payment for young farmers shall be granted per farmer for a maximum period of five years. That period shall be reduced by the number of years elapsed between the setting up referred to in point (a) of paragraph 2 and the first submission of the application for the payment for young farmers. 6. Each year, Member States not applying Article 36 shall calculate the amount of the payment for young farmers by multiplying the number of entitlements the farmer has activated in accordance with Article 32(1) by a figure corresponding to: (a) 25 % of the average value of the owned or leased-in payment entitlements held by the farmer; or (b) 25 % of an amount calculated by dividing a fixed percentage of the national ceiling for the calendar year 2019 set out in Annex II by the number of all eligible hectares declared in 2015 in accordance with Article 33(1). That fixed percentage shall be equal to the share of the national ceiling remaining for the basic payment scheme in accordance with Article 22(1) for 2015. 7. Member States applying Article 36 shall each year calculate the amount of the payment for young farmers by multiplying a figure corresponding to 25 % of the single area payment calculated in accordance with Article 36 by the number of eligible hectares that the farmer has declared in accordance with Article 36(2). 8. By way of derogation from the paragraphs 6 and 7, Member States may calculate each year the amount of the payment for young farmers by multiplying a figure corresponding to 25 % of the national average payment per hectare by the number of entitlements that the farmer has activated in accordance with Article 32(1), or by the number of eligible hectares that the farmer has declared in accordance with Article 36(2). The national average payment per hectare shall be calculated by dividing the national ceiling for the calendar year 2019 set out in Annex II by the number of eligible hectares declared in 2015 in accordance with Article 33(1) or Article 36(2). 9. Member States shall set a single maximum limit applicable to the number of payment entitlements activated by the farmer or to the number of eligible hectares declared by the farmer. That limit shall not be below 25 or above 90. Member States shall respect that limit when applying paragraphs 6, 7 and 8. 10. Instead of applying paragraphs 6 to 9, Member States may allocate an annual lump sum amount per farmer calculated by multiplying a fixed number of hectares by a figure corresponding to 25 % of the national average payment per hectare, as established in accordance with paragraph 8. The fixed number of hectares referred to in the first subparagraph of this paragraph shall be calculated by dividing the total number of eligible hectares declared pursuant to Article 33(1) or Article 36(2) by the young farmers applying for the payment for young farmers in 2015 by the total number of young farmers applying for that payment in 2015. A Member State may recalculate the fixed number of hectares in any year after 2015 in the case of significant changes in the number of young farmers applying for the payment or in the size of the holdings of young farmers, or both. The annual lump sum amount that a farmer may be granted shall not exceed the total amount of his basic payment before application of Article 63 of Regulation (EU) No 1306/2013 in the given year. 11. In order to guarantee the protection of the rights of beneficiaries and to avoid discrimination among them, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 concerning the conditions under which a legal person may be considered to be eligible to receive the payment for young farmers. Article 51 Financial provisions 1. In order to finance the payment for young farmers, Member States shall use a percentage, which shall not be higher than 2 %, of the annual national ceiling set out in Annex II. The Member States shall notify the Commission, by 1 August 2014, of the estimated percentage necessary to finance that payment. Member States may, by 1 August of each year, revise their estimated percentage with effect from the subsequent year. They shall notify the Commission of the revised percentage by 1 August of the year preceding its application. 2. Without prejudice to the maximum of 2 % laid down in paragraph 1 of this Article, where the total amount of the payment for young farmers applied for in a Member State in a particular year exceeds the ceiling set pursuant to paragraph 4 of this Article, and where that ceiling is lower than that maximum, that Member State shall finance the difference by applying point (f) of the first subparagraph of Article 30(7) in the relevant year, by applying a linear reduction to all payments to be granted to all farmers in accordance with Article 32 or Article 36(2), or by both means. 3. Where the total amount of the payment for young farmers applied for in a Member State in a particular year exceeds the ceiling set pursuant to paragraph 4 of this Article, and where that ceiling amount to 2 % of the annual national ceiling set out in Annex II, Member States shall apply a linear reduction to the amounts to be paid pursuant to Article 50 in order to comply with that ceiling. 4. On the basis of the percentage notified by Member States pursuant to paragraph 1 of this Article, the Commission shall adopt implementing acts fixing the corresponding ceilings for the payment for young farmers on a yearly basis. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). TITLE IV COUPLED SUPPORT CHAPTER 1 Voluntary coupled support Article 52 General rules 1. Member States may grant coupled support to farmers under the conditions laid down in this Chapter (in this Chapter referred to as \"coupled support\"). 2. Coupled support may be granted to the following sectors and productions: cereals, oilseeds, protein crops, grain legumes, flax, hemp, rice, nuts, starch potato, milk and milk products, seeds, sheepmeat and goatmeat, beef and veal, olive oil, silkworms, dried fodder, hops, sugar beet, cane and chicory, fruit and vegetables and short rotation coppice. 3. Coupled support may only be granted to those sectors or to those regions of a Member State where specific types of farming or specific agricultural sectors that are particularly important for economic, social or environmental reasons undergo certain difficulties. 4. By way of derogation from paragraph 3, coupled support may also be granted to farmers who: (a) on 31 December 2014, have payment entitlements granted in accordance with Section 2 of Chapter 3 of Title III and Article 71m of Regulation (EC) No 1782/2003 and in accordance with Article 60 and the fourth paragraph of Article 65 of Regulation (EC) No 73/2009; and (b) have at their disposal no eligible hectares for the activation of payment entitlements under the basic payment scheme as referred to in Chapter 1 of Title III of this Regulation. 5. Coupled support may only be granted to the extent necessary to create an incentive to maintain current levels of production in the sectors or regions concerned. 6. Coupled support shall take the form of an annual payment and shall be granted within defined quantitative limits and be based on fixed areas and yields or on a fixed number of animals. 7. In the case of a legal person, or a group of natural or legal persons, Member States may apply the limits referred to in paragraph 6 at the level of the members of those legal persons or groups where national law provides for the individual members to assume rights and obligations comparable to those of individual farmers who have the status of a head of holding, in particular as regards their economic, social and tax status, provided that they have contributed to strengthening the agricultural structures of the legal persons or groups concerned. 8. Any coupled support granted under this Article shall be consistent with other Union measures and policies. 9. In order to ensure efficient and targeted use of Union funds and to avoid double funding under other similar support instruments, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down: (a) the conditions for granting coupled support; (b) rules on consistency with other Union measures and on the cumulation of support. Article 53 Financial provisions 1. In order to finance the coupled support, Member States may, by 1 August of the year preceding the first year of implementation of such support, decide to use up to 8 % of their annual national ceiling set out in Annex II. 2. By way of derogation from paragraph 1, Member States may decide to use up to 13 % of the annual national ceiling set out in Annex II, provided that: (a) until 31 December 2014: (i) they apply the single area payment scheme laid down in Title V of Regulation (EC) No 73/2009, (ii) they finance measures under Article 111 of that Regulation, or (iii) they are covered by the derogation provided for in Article 69(5) or, in the case of Malta, in Article 69(1) of that Regulation; and/or (b) they allocate, in total, during at least one year in the period 2010-2014, more than 5 % of their amount available for granting the direct payments provided for in Title III, Title IV, with the exception of Section 6 of Chapter 1 thereof, and Title V of Regulation (EC) No 73/2009 for financing: (i) the measures laid down in Section 2 of Chapter 2 of Title III of Regulation (EC) No 73/2009, (ii) the support provided for in subpoints (i) to (iv) of point (a) and in points (b) and (e) of Article 68(1) of that Regulation, or (iii) the measures under Chapter 1, with the exception of Section 6 of Title IV of that Regulation. 3. The percentages of the annual national ceiling referred to in paragraphs 1 and 2 may be increased by up to two percentage points for those Member States which decide to use at least 2 % of their annual national ceiling set out in Annex II to support the production of protein crops under this Chapter. 4. By way of derogation from paragraphs 1 and 2, Member States allocating, in total, during at least one year in the period 2010-2014, more than 10 % of their amount available for granting the direct payments provided for in Title III, Title IV, with the exception of Section 6 of Chapter 1 thereof, and Title V of Regulation (EC) No 73/2009 for financing: (a) the measures laid down in Section 2 of Chapter 2 of Title III of Regulation (EC) No 73/2009; (b) the support provided for in subpoints (i) to (iv) of point (a) and in points (b) and (e) of Article 68(1) of that Regulation; or (c) the measures under Chapter 1, with the exception of Section 6, of Title IV of that Regulation may decide to use more than 13 % of the annual national ceiling set out in Annex II to this Regulation, upon approval by the Commission in accordance with Article 55 of this Regulation. 5. By way of derogation from the percentages set out in paragraphs 1 to 4, Member States may choose to use up to EUR 3 million per year for financing coupled support. 6. Member States may, by 1 August 2016, review their decision pursuant to paragraphs 1 to 4 and decide, with effect from 2017: (a) to leave unchanged, increase or decrease the percentage fixed pursuant to paragraphs 1, 2 and 3, within the limits laid down therein where applicable, or to leave unchanged or decrease the percentage fixed pursuant to paragraph 4; (b) to modify the conditions for granting the support; (c) to cease granting the support under this Chapter. 7. On the basis of the decision taken by each Member State pursuant to paragraphs 1 to 6 of this Article, the Commission shall adopt implementing acts fixing the corresponding ceilings for coupled support on a yearly basis. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 54 Notification 1. Member States shall notify the Commission of the decisions referred to in Article 53 by the dates referred to in that Article. Except for the decision referred to in point (c) of Article 53(6), the notification shall include information on the regions targeted, the selected types of farming or sectors, and the level of support to be granted. 2. The decisions referred to in Article 53(2) and (4), or, where appropriate, in point (a) of Article 53(6), shall include a detailed description of the particular situation in the region targeted and of the particular characteristics of the types of farming or specific agricultural sectors, which make the percentage referred to in Article 53(1) insufficient to address the difficulties referred to in Article 52(3) and which justify an increased level of support. Article 55 Approval by the Commission 1. The Commission shall adopt implementing acts, without applying the procedure referred to in Article 71(2) or (3), approving the decision referred to in Article 53(4), or, where appropriate, in point (a) of Article 53(6), where one of the following needs in the sector or region concerned is demonstrated: (a) the need to sustain a certain level of specific production due to the lack of alternatives, and to reduce the risk of production abandonment with the resulting social and/or environmental problems; (b) the need to provide stable supply to the local processing industry, thereby avoiding the negative social and economic consequence of any ensuing restructuring; (c) the need to compensate disadvantages affecting farmers in a particular sector which are the consequence of continuing disturbances on the related market; (d) the need to intervene where the existence of any other support available under this Regulation, Regulation (EU) No 1305/2013 or any approved State aid scheme is deemed to be insufficient to meet the needs referred to in points (a), (b) and (c) of this paragraph. 2. The Commission shall adopt implementing acts laying down rules on the procedure for the assessment and approval of the decisions referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). CHAPTER 2 Crop-specific payment for cotton Article 56 Scope Aid shall be granted to farmers producing cotton falling within CN code 5201 00 under the conditions laid down in this Chapter (\"crop-specific payment for cotton\"). Article 57 Eligibility 1. The crop-specific payment for cotton shall be granted per hectare of eligible area of cotton. The area shall be eligible only if it is located on agricultural land authorised by the Member State for cotton production, sown with varieties authorised by the Member State and actually harvested under normal growing conditions. The crop-specific payment for cotton shall be paid for cotton of sound, fair and marketable quality. 2. Member States shall authorise the land and the varieties referred to in paragraph 1 in accordance with the rules and conditions to be adopted pursuant to paragraph 3. 3. In order to ensure an efficient management of the crop-specific payment for cotton, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 concerning rules and conditions for the authorisation of land and varieties for the purposes of the crop-specific payment for cotton. 4. The Commission shall adopt implementing acts laying down rules on the procedure for the authorisation of land and varieties for the purposes of the crop-specific payment for cotton and on the notifications to the producers related to this authorisation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 58 Base areas, fixed yields and reference amounts 1. The following national base areas are established: \u2014 Bulgaria: 3 342 ha, \u2014 Greece: 250 000 ha, \u2014 Spain: 48 000 ha, \u2014 Portugal: 360 ha. 2. The following fixed yields in the reference period are established: \u2014 Bulgaria: 1,2 tonne/ha, \u2014 Greece: 3,2 tonne/ha, \u2014 Spain: 3,5 tonne/ha, \u2014 Portugal: 2,2 tonne/ha. 3. The amount of the crop-specific payment per hectare of eligible area shall be calculated by multiplying the yields established in paragraph 2 with the following reference amounts: \u2014 Bulgaria: EUR 584,88 in 2015; and EUR 649,45 for 2016 and onwards, \u2014 Greece: EUR 234,18, \u2014 Spain: EUR 362,15, \u2014 Portugal: EUR 228,00. 4. If the eligible area of cotton in a given Member State and in a given year exceeds the base area established in paragraph 1, the amount referred to in paragraph 3 for that Member State shall be reduced proportionately to the overrun of the base area. 5. In order to make it possible to apply the crop-specific payment for cotton, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 concerning rules on the conditions for the granting of that payment, on the eligibility requirements and on agronomic practices. 6. The Commission may adopt implementing acts laying down rules on the calculation of the reduction provided for in paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 59 Approved interbranch organisations 1. For the purpose of this Chapter, an 'approved interbranch organisation' means a legal entity made up of farmers producing cotton and at least one ginner, carrying out activities such as: (a) helping to better coordinate the way cotton is placed on the market, particularly through research studies and market surveys; (b) drawing up standard forms of contract compatible with Union rules; (c) orienting production towards products that are better adapted to market needs and consumer demand, particularly in terms of quality and consumer protection; (d) updating methods and means to improve product quality; (e) developing marketing strategies to promote cotton via quality certification schemes. 2. The Member State where the ginners are established shall approve interbranch organisations that satisfy the criteria to be laid down pursuant to paragraph 3. 3. In order to ensure the efficient application of the crop-specific payment for cotton, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down: (a) criteria for the approval of interbranch organisations; (b) obligations for producers; (c) rules governing the situation where the approved interbranch organisation does not satisfy the criteria referred to in point (a). Article 60 Granting of the payment 1. Farmers shall be granted the crop-specific payment for cotton per eligible hectare as established in Article 58. 2. In the case of farmers who are members of an approved interbranch organisation, the crop-specific payment for cotton per eligible hectare within the base area laid down in Article 58(1) shall be increased by an amount of EUR 2. TITLE V SMALL FARMERS SCHEME Article 61 General rules 1. Member States may establish a scheme for small farmers in accordance with the conditions laid down in this Title (\"small farmers scheme\"). Farmers who, in 2015, hold owned or leased-in payment entitlements or, in Member States applying Article 36, claim for the single area payment scheme, and fulfil the minimum requirements provided for in Article 10(1) may opt to participate in the small farmers scheme. 2. Payments under the small farmers scheme shall replace the payments to be granted pursuant to Titles III and IV. The first subparagraph shall not apply where a Member State opts for the payment method laid down in point (a) of the first subparagraph of Article 63(2). In that case, the payment shall be subject to the respective conditions laid down in Titles III and IV, without prejudice to paragraph 3 of this Article. 3. Farmers participating in the small farmers scheme shall be exempted from the agricultural practices provided for in Chapter 3 of Title III. 4. No advantage provided for under this Title shall be granted in favour of farmers in respect of whom it is established that they artificially created, after 18 October 2011, the conditions to benefit from the small farmers scheme. Article 62 Participation 1. Farmers wishing to participate in the small farmers scheme shall submit an application by a date to be fixed by Member States which shall not be later than 15 October 2015. The date fixed by Member States cannot, however, be earlier than the last day for submitting an application under the basic payment scheme or the single area payment scheme. Farmers who have not applied to participate in the small farmers scheme on the date fixed by the Member State, who decide to withdraw from it after that date or who have been selected for support under point (c) of Article 19(1) of Regulation (EU) No 1305/2013 shall no longer be entitled to participate in that scheme. 2. By way of derogation from paragraph 1, Member States may provide that farmers whose amount of direct payments under Titles III and IV is lower than the maximum amount fixed by the Member State in accordance with Article 63 are to be included in the small farmers scheme automatically, unless they expressly withdraw from it by the date fixed by the Member State in accordance with paragraph 1 or in any subsequent year. Member States making use of this possibility shall inform the relevant farmers in due time about their right to withdraw from the scheme. 3. Each Member State shall ensure that an estimate of the amount of the payment referred to in Article 63 is made known to farmers in due time before the date for submitting applications or for withdrawal fixed by that Member State. Article 63 Amount of the payment 1. Member States shall set the amount of the annual payment for each farmer participating in the small farmers scheme at one of the following levels: (a) an amount not exceeding 25 % of the national average payment per beneficiary, which shall be established by the Member States on the basis of the national ceiling set out in Annex II for calendar year 2019 and the number of farmers who have declared eligible hectares, pursuant to Article 33(1) or Article 36(2), in 2015; (b) an amount corresponding to the national average payment per hectare multiplied by a figure corresponding to a number of hectares not exceeding five, to be set by the Member States. The national average payment per hectare shall be established by the Member States on the basis of the national ceiling set out in Annex II for calendar year 2019 and the number of eligible hectares declared in accordance with Article 33(1) or Article 36(2) in 2015. The amount referred to in points (a) or (b) of the first subparagraph shall not be lower than EUR 500 and shall not be higher than EUR 1 250. Where the application of points (a) and (b) of the first subparagraph results in an amount lower than EUR 500 or higher than EUR 1 250, the amount shall be rounded up or down, respectively, to that minimum or maximum amount. 2. By way of derogation from paragraph 1, a Member State may decide to grant participating farmers: (a) an amount equal to the total value of the payments to be allocated to the farmer each year under Titles III and IV; or (b) an amount equal to the total value of the payments to be allocated to the farmer in 2015 under Titles III and IV, that the Member State may adjust in subsequent years to proportionately take into account the changes in the national ceiling set out in Annex II. The amount referred to in point (a) or (b) of the first subparagraph shall not be higher than an amount fixed by that Member State which shall be between EUR 500 and EUR 1 250. Where the application of point (a) or (b) of the first subparagraph results in an amount lower than EUR 500, the Member State concerned may decide to round up this amount to EUR 500. 3. By way of derogation from paragraphs 1 and 2, in Cyprus, Croatia, Malta and Slovenia, the amount referred to in those paragraphs may be set at a value lower than EUR 500, but not less than EUR 200 or, in the case of Malta, not less than EUR 50. Article 64 Special conditions 1. During the participation in the small farmers scheme, farmers shall: (a) keep at least a number of eligible hectares corresponding to the number of owned or leased-in payment entitlements held, or to the number of eligible hectares declared in 2015 in accordance with Article 36(2); (b) fulfil the minimum requirement provided for in point (b) of Article 10(1). 2. Payment entitlements activated in 2015 pursuant to Articles 32 and 33 by a farmer participating in the small farmers scheme shall be considered to be activated entitlements for the duration of the farmer's participation in that scheme. The owned or leased-in payment entitlements held by the farmer during the participation in that scheme shall not be considered to be unused payment entitlements which are to revert to the national reserve or regional reserves in accordance with point (b) of Article 31(1). In Member States applying Article 36, the eligible hectares declared in 2015 in accordance with Article 36(2) by a farmer participating in the small farmers scheme shall be considered to be declared for the duration of the participation of the farmer in that scheme. 3. By way of derogation from Article 34, payment entitlements held by farmers participating in the small farmers scheme shall not be transferable, except in the case of inheritance or anticipated inheritance. Farmers who, by way of inheritance or anticipated inheritance, receive payment entitlements from a farmer participating in the small farmers scheme shall be eligible to participate in that scheme provided that they meet the requirements to benefit from the basic payment scheme and that they inherit all the payment entitlements held by the farmer from whom they receive the payment entitlements. 4. Where a Member State opts for the payment method laid down in point (a) of the first subparagraph of Article 63(2) without applying the third subparagraph of Article 63(2), paragraphs 1 and 2 as well as the first subparagraph of paragraph 3 of this Article shall not apply. 5. In order to ensure legal certainty, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 setting out the conditions for participation in the scheme where the situation of the participating farmer has changed. Article 65 Financial provisions 1. In order to finance the payment referred to in this Title, Member States shall deduct from the total amounts available for the respective payments the amounts to which the small farmers would be entitled: (a) under the basic payment scheme or the single area payment scheme referred to in Chapter 1 of Title III; (b) as a redistributive payment referred to in Chapter 2 of Title III; (c) as a payment for agricultural practices beneficial for the climate and the environment referred to in Chapter 3 of Title III; (d) as a payment for areas with natural constraints referred to in Chapter 4 of Title III; (e) as a payment for young farmers referred to in Chapter 5 of Title III; and (f) as coupled support referred to in Title IV. In the case of Member States having opted to calculate the amount of the payment pursuant to point (a) of the first subparagraph of Article 63(2), where the sum of those amounts for an individual farmer exceeds the maximum amount that they have fixed, each amount shall be proportionately reduced. 2. The difference between the sum of all payments due under the small farmers scheme and the total amount financed in accordance with paragraph 1 shall be financed in one or more of the following ways: (a) by applying Article 30(7) in the relevant year; (b) by using the funds for financing the payment for young farmers laid down in Chapter 5 of Title III which are left unused in the relevant year; (c) by applying a linear reduction to all payments to be granted in accordance with Articles 32 or 36. 3. Except where a Member State has opted to set the amount of the annual payment pursuant to point (a) of the first subparagraph of Article 63(2), the elements on the basis of which the amounts referred to in paragraph 1 of this Article are established shall remain the same for the entire duration of the participation of the farmer in the small farmers scheme. 4. If the total amount of payments due under the small farmers scheme exceeds 10 % of the annual national ceiling set out in Annex II, Member States shall apply a linear reduction to the amounts to be paid in accordance with this Title in order to respect that percentage, unless they have set the amount of the payment in accordance with point (a) of the first subparagraph of Article 63(2) without applying the third subparagraph of Article 63(2). The same exception applies for Member States which have set the amount of the payment in accordance with point (b) of the first subparagraph of Article 63(2) without applying the third subparagraph of Article 63(2), whose national ceiling set out in Annex II for year 2019 is higher than for year 2015 and which apply the calculation method set out in Article 25(1) or in Article 36(2). TITLE VI NATIONAL RESTRUCTURING PROGRAMMES FOR THE COTTON SECTOR Article 66 Use of the annual budget for the restructuring programmes 1. For Member States which have applied the first subparagraph of Article 4(1) of Regulation (EC) No 637/2008, the relevant annual budget available pursuant to Article 5(1) of that Regulation shall be transferred with effect from 1 January 2014 and shall constitute additional Union funds for measures under rural development programming financed under Regulation (EU) No 1305/2013. 2. For Member States which have applied the second subparagraph of Article 4(1) of Regulation (EC) No 637/2008, the relevant annual budget available pursuant to Article 5(1) of that Regulation shall be included with effect from 1 January 2017 in their national ceilings as set out in Annex II to this Regulation. TITLE VII FINAL PROVISIONS CHAPTER 1 Notifications and emergency Article 67 Notification requirements 1. In order to ensure the correct application of the rules set out in this Regulation, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 on the necessary measures regarding notifications to be made by Member States to the Commission for the purposes of this Regulation, for the purpose of checking, controlling, monitoring, evaluating and auditing direct payments or for the purpose of complying with requirements laid down in international agreements which have been concluded by a Council decision, including notification requirements under those agreements. In so doing, the Commission shall take into account the data needs and synergies between potential data sources. Where appropriate, the information obtained may be transmitted or be made available to international organisations and the competent authorities of third countries and may be made public, subject to the protection of personal data and the legitimate interest of undertakings in the protection of their business secrets. 2. In order to make notifications referred to in paragraph 1 fast, efficient, accurate and cost-effective, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down further rules on: (a) the nature and type of the information to be notified; (b) the categories of data to be processed and maximum retention periods; (c) access rights to the information or information systems made available; (d) the conditions of publication of the information. 3. The Commission shall adopt implementing acts laying down: (a) the methods of notification; (b) rules on providing the information necessary for the application of this Article; (c) arrangements for the management of the information to be notified, as well as rules on content, form, timing, frequency and deadlines of the notifications; (d) arrangements for transmitting, or making information and documents available, to the Member States, international organisations, the competent authorities in third countries, or the public, subject to the protection of personal data and the legitimate interest of farmers and undertakings in the protection of their business secrets. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). Article 68 Processing and protection of personal data 1. Member States and the Commission shall collect personal data for the purposes set out in Article 67(1). They shall not process this data in a way that is incompatible with those purposes. 2. Where personal data are processed for monitoring and evaluation purposes as referred to in Article 67(1), they shall be made anonymous and processed in aggregated form only. 3. Personal data shall be processed in accordance with Directive 95/46/EC and Regulation (EC) No 45/2001. In particular, such data shall not be stored in a form which permits identification of data subjects for longer than is necessary for the purposes for which they were collected or for which they are further processed, taking into account the minimum retention periods laid down in the applicable national and Union law. 4. Member States shall inform the data subjects that their personal data may be processed by national and Union bodies in accordance with paragraph 1, and that in this respect they enjoy the rights set out in Directive 95/46/EC and Regulation (EC) No 45/2001, respectively. 5. This Article shall be subject to Articles 111 to 114 of Regulation (EU) No 1306/2013. Article 69 Measures to resolve specific problems 1. In order to resolve specific problems, the Commission shall adopt implementing acts which are both necessary and justifiable in an emergency. Such implementing acts may derogate from provisions of this Regulation, to the extent and for such a period as is strictly necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 71(2). 2. Where duly justified imperative grounds of urgency so require, and in order to resolve such specific problems while ensuring the continuity of the direct payments system in the case of extraordinary circumstances, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 71(3). 3. Measures adopted under paragraph 1 or 2 shall remain in force for a period not exceeding twelve months. If after this period the specific problems referred to in those paragraphs persist, the Commission may, in order to establish a permanent solution, submit an appropriate legislative proposal. 4. The Commission shall inform the European Parliament and the Council of any measure adopted under paragraph 1 or 2 within two working days of its adoption. CHAPTER 2 Delegations of powers and implementing provisions Article 70 Exercise of the delegation 1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 2, Article 4(3), Article 6(3), Article 7(3), Article 8(3), Article 9(5), Article 20(6), Article 35, Article 36(6), Article 39(3), Article 43(12), Article 44(5), Article 45(5) and (6), Article 46(9), Article 50(11), Article 52(9), Article 57(3), Article 58(5), Article 59(3), Article 64(5), Article 67(1) and (2) and Article 73 shall be conferred on the Commission for a period of seven years from 1 January 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 2, Article 4(3), Article 6(3), Article 7(3), Article 8(3), Article 9(5), Article 20(6), Article 35, Article 36(6), Article 39(3), Article 43(12), Article 44(5), Article 45(5) and (6), Article 46(9), Article 50(11), Article 52(9), Article 57(3), Article 58(5), Article 59(3), Article 64(5), Article 67(1) and (2) and Article 73 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 2, Article 4(3), Article 6(3), Article 7(3), Article 8(3), Article 9(5), Article 20(6), Article 35, Article 36(6), Article 39(3), Article 43(12), Article 44(5), Article 45(5) and (6), Article 46(9), Article 50(11), Article 52(9), Article 57(3), Article 58(5), Article 59(3), Article 64(5), Article 67(1) and (2) and Article 73 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 71 Committee procedure 1. The Commission shall be assisted by a Committee called the \"Committee for Direct Payments\". That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. In the case of acts referred to in Article 24(11), Article 31(2) and Article 67(3), where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. CHAPTER 3 Transitional and final provisions Article 72 Repeals 1. Regulation (EC) No 637/2008 is repealed with effect from 1 January 2014. However, it shall continue to apply until 31 December 2017 in respect of Member States which have exercised the option laid down in the second subparagraph of Article 4(1) of that Regulation. 2. Regulation (EC) No 73/2009 is repealed. Without prejudice to paragraph 3, references to the repealed Regulation shall be construed as references to this Regulation or Regulation (EU) No 1306/2013 and shall be read in accordance with the correlation table set out in Annex XI to this Regulation. 3. The references made in this Regulation to Regulations (EC) No 73/2009 and (EC) No 1782/2003 shall be understood as being made to those Regulations such as they were in force before their repeal. Article 73 Transitional rules In order to ensure a smooth transition from the arrangements provided for in Regulation (EC) No 73/2009 to those laid down in this Regulation, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 concerning the necessary measures to protect any acquired rights and legitimate expectations of farmers. Article 74 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2015. However, Article 8, Article 9(6), Article 11(6), Article 14, Article 16, Article 21(2) and (3), Article 22(2), the first subparagraph of Article 23(1), Article 23(6), Article 24(10), Article 29, the first subparagraph of Article 36(1), Article 41(1), Article 42(1), Article 43(8) and (13), the fifth subparagraph of Article 45(2), Article 46(2) and (8), Article 49(1), Article 51(1), Article 53, Article 54, Article 66(1), Articles 67 and 70 and Article 72(1) shall apply from the date of entry into force of this Regulation. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 December 2013. For the European Parliament The President M. SCHULZ For the Council The President V. JUKNA (1) Opinion of 8 March 2012 (not yet published in the Official Journal). (2) OJ C 191, 29.6.2012, p. 116 and OJ C 44, 15.2.2013, p. 159. (3) OJ C 225, 27.7.2012, p. 174. (4) Position of the European Parliament of 20 November 2013 (not yet published in the Official Journal). (5) Council Regulation (EC) No 73/2009 of 19 January 2009 establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers, amending Regulations (EC) No 1290/2005, (EC) No 247/2006, (EC) No 378/2007 and repealing Regulation (EC) No 1782/2003 (OJ L 30, 31.1.2009, p. 16). (6) Regulation (EU) No 1306/2013 of the European Parliament and of Council of 17 december 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (See page 549 of this Official Journal). (7) Regulation (EU) No 228/2013 of the European Parliament and of the Council of 13 March 2013 laying down specific measures for agriculture in the outermost regions of the Union and repealing Council Regulation (EC) No 247/2006 (OJ L 78, 20.3.2013, p. 23). (8) Regulation (EU) No 229/2013 of the European Parliament and of the Council of 13 March 2013 laying down specific measures for agriculture in favour of the smaller Aegean islands and repealing Council Regulation (EC) No 1405/2006 (OJ L 78, 20.3.2013, p. 41). (9) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (10) Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers and amending Regulations (EEC) No 2019/93, (EC) No 1452/2001, (EC) No 1453/2001, (EC) No 1454/2001, (EC) 1868/94, (EC) No 1251/1999, (EC) No 1254/1999, (EC) No 1673/2000, (EEC) No 2358/71 and (EC) No 2529/2001 (OJ L 270, 21.10.2003, p. 1). (11) Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (OJ L 277, 21.10.2005, p. 1). (12) Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 december 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (See page 487 of this Official Journal). (13) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). (14) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). (15) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (16) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1). (17) Council Regulation (EC) No 637/2008 of 23 June 2008 amending Regulation (EC) No 1782/2003 and establishing national restructuring programmes for the cotton sector (OJ L 178, 5.7.2008, p. 1). (18) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (19) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (20) OJ C 35, 9.2.2012, p. 1. (21) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 december 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1601/96, (EC) No 1037/2001 and (EC) No 1234/2007 (See page 671 of this Official Journal). (22) Commission Regulation (EC) No 1122/2009 of 30 November 2009 laying down detailed rules for the implementation of Council Regulation (EC) No 73/2009 as regards cross-compliance, modulation and the integrated administration and control system, under the direct support schemes for farmers provided for that Regulation, as well as for the implementation of Council Regulation (EC) No 1234/2007 as regards cross-compliance under the support scheme provided for the wine sector (OJ L 316, 2.12.2009, p. 65). ANNEX I List of support schemes Sector Legal base Notes Basic payment scheme Title III, Chapter 1, Sections 1, 2, 3 and 5 of this Regulation Decoupled payment Single area payment scheme Article 36 of this Regulation Decoupled payment Redistributive payment Title III, Chapter 2 of this Regulation Decoupled payment Payment for agricultural practices beneficial for the climate and the environment Title III, Chapter 3 of this Regulation Decoupled payment Payment for areas with natural constraints Title III, Chapter 4 of this Regulation Decoupled payment Payment for young farmers Title III, Chapter 5 of this Regulation Decoupled payment Voluntary coupled support Title IV, Chapter 1 of this Regulation Crop-specific payment for cotton Title IV, Chapter 2 of this Regulation Area payment Small farmers scheme Title V of this Regulation Decoupled payment Posei Chapter IV of Regulation (EU) No 228/2013 Direct payments under measures established in the programmes Aegean islands Chapter IV of Regulation (EU) No 229/2013 Direct payments under measures established in the programmes ANNEX II National ceilings referred to in Article 6 (in thousands EUR) Calendar year 2015 2016 2017 2018 2019 and the subsequent year Belgium 536 076 528 124 520 170 512 718 505 266 Bulgaria 721 251 792 449 793 226 794 759 796 292 Czech Republic 874 484 873 671 872 830 872 819 872 809 Denmark 916 580 907 108 897 625 889 004 880 384 Germany 5 144 264 5 110 446 5 076 522 5 047 458 5 018 395 Estonia 121 870 133 701 145 504 157 435 169 366 Ireland 1 215 003 1 213 470 1 211 899 1 211 482 1 211 066 Greece 2 039 122 2 015 116 1 991 083 1 969 129 1 947 177 Spain 4 842 658 4 851 682 4 866 665 4 880 049 4 893 433 France 7 553 677 7 521 123 7 488 380 7 462 790 7 437 200 Croatia (1) 130 550 149 200 186 500 223 800 261 100 Italy 3 902 039 3 850 805 3 799 540 3 751 937 3 704 337 Cyprus 50 784 50 225 49 666 49 155 48 643 Latvia 195 649 222 363 249 020 275 887 302 754 Lithuania 417 890 442 510 467 070 492 049 517 028 Luxembourg 33 603 33 545 33 486 33 459 33 431 Hungary 1 271 593 1 270 410 1 269 187 1 269 172 1 269 158 Malta 5 127 5 015 4 904 4 797 4 689 Netherlands 780 815 768 340 755 862 744 116 732 370 Austria 693 065 692 421 691 754 691 746 691 738 Poland 2 987 267 3 004 501 3 021 602 3 041 560 3 061 518 Portugal 565 816 573 954 582 057 590 706 599 355 Romania 1 629 889 1 813 795 1 842 446 1 872 821 1 903 195 Slovenia 137 987 136 997 136 003 135 141 134 278 Slovakia 380 680 383 938 387 177 390 781 394 385 Finland 523 333 523 422 523 493 524 062 524 631 Sweden 696 890 697 295 697 678 698 723 699 768 United Kingdom 3 555 915 3 563 262 3 570 477 3 581 080 3 591 683 (1) For Croatia, the national ceiling for calendar year 2020 shall be EUR 298 400 000, for 2021 shall be EUR 335 700 000 and for 2022 shall be EUR 373 000 000. ANNEX III Net ceilings referred to in Article 7 (in million EUR) Calendar year 2015 2016 2017 2018 2019 and the subsequent year Belgium 536,1 528,1 520,2 512,7 505,3 Bulgaria 723,6 795,1 795,8 797,4 798,9 Czech Republic 874,5 873,7 872,8 872,8 872,8 Denmark 916,6 907,1 897,6 889,0 880,4 Germany 5 144,3 5 110,4 5 076,5 5 047,5 5 018,4 Estonia 121,9 133,7 145,5 157,4 169,4 Ireland 1 215,0 1 213,5 1 211,9 1 211,5 1 211,1 Greece 2 227,0 2 203,0 2 178,9 2 157,0 2 135,0 Spain 4 903,6 4 912,6 4 927,6 4 941,0 4 954,4 France 7 553,7 7 521,1 7 488,4 7 462,8 7 437,2 Croatia (1) 130,6 149,2 186,5 223,8 261,1 Italy 3 902,0 3 850,8 3 799,5 3 751,9 3 704,3 Cyprus 50,8 50,2 49,7 49,2 48,6 Latvia 195,6 222,4 249,0 275,9 302,8 Lithuania 417,9 442,5 467,1 492,0 517,0 Luxembourg 33,6 33,5 33,5 33,5 33,4 Hungary 1 271,6 1 270,4 1 269,2 1 269,2 1 269,2 Malta 5,1 5,0 4,9 4,8 4,7 Netherlands 780,8 768,3 755,9 744,1 732,4 Austria 693,1 692,4 691,8 691,7 691,7 Poland 2 987,3 3 004,5 3 021,6 3 041,6 3 061,5 Portugal 566,0 574,1 582,2 590,9 599,5 Romania 1 629,9 1 813,8 1 842,4 1 872,8 1 903,2 Slovenia 138,0 137,0 136,0 135,1 134,3 Slovakia 380,7 383,9 387,2 390,8 394,4 Finland 523,3 523,4 523,5 524,1 524,6 Sweden 696,9 697,3 697,7 698,7 699,8 United Kingdom 3 555,9 3 563,3 3 570,5 3 581,1 3 591,7 (1) For Croatia, the net ceiling for calendar year 2020 shall be EUR 298 400 000, for 2021 shall be EUR 335 700 000 and for 2022 shall be EUR 373 000 000. ANNEX IV Limits for the adjustment for the thresholds, referred to in Article 10(2) Member State Limit for the EUR threshold (Article 10(1)(a)) Limit for the hectare threshold (Article 10(1)(b)) Belgium 400 2 Bulgaria 200 0,5 Czech Republic 200 5 Denmark 300 5 Germany 300 4 Estonia 100 3 Ireland 200 3 Greece 400 0,4 Spain 300 2 France 300 4 Croatia 100 1 Italy 400 0,5 Cyprus 300 0,3 Latvia 100 1 Lithuania 100 1 Luxemburg 300 4 Hungary 200 0,3 Malta 500 0,1 Netherlands 500 2 Austria 200 2 Poland 200 0,5 Portugal 200 0,3 Romania 200 0,3 Slovenia 300 0,3 Slovakia 200 2 Finland 200 3 Sweden 200 4 United Kingdom 200 5 ANNEX V Financial provisions applying to Bulgaria and Romania referred to in Articles 10, 16 and 18 A. Amounts for applying point (a) of Article 10(1) and for calculating the national ceilings for payments referred to in Article 16 in 2015: Bulgaria : EUR 790 909 000 Romania : EUR 1 783 426 000 B. Total amount of complementary national direct payments to the basic payment scheme referred to in Article 18(1) in 2015: Bulgaria : EUR 69 657 000 Romania : EUR 153 536 000 C. Total amount of complementary national direct payments to the crop-specific payment for cotton referred to in Article 18(2) in 2015: Bulgaria : EUR 258 952 ANNEX VI Financial provisions applying to Croatia referred to in Articles 10 and 19 A. Amount for applying point (a) of Article 10(1): EUR 373 000 000 B. Total amounts of complementary national direct payments referred to in Article 19(3): (in thousands EUR) 2015 2016 2017 2018 2019 2020 2021 242 450 223 800 186 500 149 200 111 900 74 600 37 300 ANNEX VII Maximum amounts to be added to the amounts set out in Annex II in accordance with Article 20(2) (in thousands EUR) 2015 2016 2017 2018 2019 2020 2021 2022 3 360 3 840 4 800 5 760 6 720 7 680 8 640 9 600 ANNEX VIII Average size of agricultural holding referred to in Article 41(4) Member State Average size of agricultural holding (in hectares) Belgium 29 Bulgaria 6 Czech Republic 89 Denmark 60 Germany 46 Estonia 39 Ireland 32 Greece 5 Spain 24 France 52 Croatia 5,9 Italy 8 Cyprus 4 Latvia 16 Lithuania 12 Luxemburg 57 Hungary 7 Malta 1 Netherlands 25 Austria 19 Poland 6 Portugal 13 Romania 3 Slovenia 6 Slovakia 28 Finland 34 Sweden 43 United Kingdom 54 ANNEX IX List of equivalent practices referred to in Article 43(3) I. Practices equivalent to crop diversification: (1) Crop diversification Requirement: at least three crops, the main crop covering a maximum of 75 %, and any one or more of the following applying: \u2014 there are at least four crops, \u2014 lower maximum thresholds apply, \u2014 there is a more appropriate selection of crops, such as, for example, leguminous, protein crops, crops not requiring irrigation or pesticide treatments, as appropriate, \u2014 regional varieties of old, traditional or endangered crop types are included on at least 5 % of the rotated area. (2) Crop rotation Requirement: at least three crops, the main crop covering a maximum of 75 %, and any one or both of the following applying: \u2014 a more environmentally beneficial multiannual sequence of crops and/or fallow is followed, \u2014 there are at least four crops. (3) Winter soil cover (1) (4) Catch crops (1) II. Practices equivalent to maintenance of permanent grassland: (1) Management of meadows or pastures Requirement: maintenance of permanent grassland and any one or more of the following: \u2014 Cutting regime or appropriate mowing (dates, methods, limits) \u2014 Maintenance of landscape features on permanent grassland and control of scrub \u2014 Specified grass varieties and/or seeding regime for renewal depending on the grassland type, with no destruction of high nature value \u2014 Evacuation of forage or hay \u2014 Appropriate management for steep slopes \u2014 Fertiliser regime \u2014 Pesticide restrictions (2) Extensive grazing systems Requirement: maintenance of permanent grassland and any one or more of the following: \u2014 Extensive grazing (timing, maximum stocking density) \u2014 Shepherding or mountain pastoralism \u2014 Using local or traditional breeds for grazing the permanent grassland III. Practices equivalent with ecological focus area: Requirement: application of any of the following practices on at least the percentage of the arable land set pursuant to Article 46(1): (1) Ecological set-aside (2) Creation of \"buffer zones\" for high nature value areas, Natura 2000 or other biodiversity protection sites, including along hedgerows and water courses (3) Management of uncultivated buffer strips and field margins (cutting regime, local or specified grass varieties and/or seeding regime, re-seeding with regional varieties, no use of pesticides, no disposal of manure and/or mineral fertilisers, no irrigation, no soil sealing) (4) Borders, in-field strips and patches managed for wildlife or specific fauna (herbaceous border, protection of nests, wildflower strips, local seed mix, unharvested crops) (5) Management (pruning, trimming, dates, methods, restoration) of landscape features (trees, hedgerows, riparian woody vegetation, stone walls (terraces), ditches, ponds) (6) Keeping arable peaty or wet soils under grass (with no use of fertilisers and no use of plant protection products) (7) Production on arable land with no use of fertiliser (mineral fertiliser and manure) and/or plant protection products, and not irrigated, not sown with the same crop two years in a row and on a fixed place (1) (8) Conversion of arable land into permanent grassland extensively used (1) Practices subject to the calculation referred to in point (c) of Article 43(12) ANNEX X Conversion and weighting factors referred to in Article 46(3) Features Conversion factor Weighting factor Ecological focus area Land lying fallow Terraces Landscape features Buffer strips Hectares of agro-forestry Strips of eligible hectares along forest edges Areas with short rotation coppice Afforested areas referred to in Article 32(2)(b)(ii) Areas with catch crops or green cover Areas with nitrogen-fixing crops ANNEX XI Correlation table referred to in Article 72(2) Regulation (EC) No 73/2009 This Regulation Regulation (EU) No 1306/2013 Article 1 Article 1 \u2014 Article 2 Article 4 \u2014 Article 3 Article 5 \u2014 Article 4(1) \u2014 Article 91 Article 4(2) \u2014 Article 95 Article 5 \u2014 Article 93 Article 6(1) \u2014 Article 94 Article 6(2) \u2014 \u2014 Article 7 \u2014 \u2014 Article 8 Article 7 \u2014 Article 9 \u2014 \u2014 Article 10 \u2014 \u2014 Article 10a \u2014 \u2014 Article 10b \u2014 \u2014 Article 10c \u2014 \u2014 Article 10d \u2014 \u2014 Article 11 Article 8 Article 26(1) and (2) Article 11(3) Article 8(2) \u2014 Article 11a Article 8(3) \u2014 Article 12(1) and (2) \u2014 Article 12 Article 12(3) \u2014 Article 14 Article 12(4) \u2014 \u2014 Article 13 \u2014 Article 13(2) Article 14 \u2014 Article 67 Article 15 \u2014 Article 68(1) and (2) Article 16 \u2014 Article 69 Article 17 \u2014 Article 70 Article 18 \u2014 Article 71 Article 19 \u2014 Article 72 Article 20 \u2014 Article 74(1), (2) and (3) Article 21 \u2014 Article 74(4) Article 22 \u2014 Article 96 Article 23 \u2014 Article 97 Article 24 \u2014 Article 99 Article 25 \u2014 Article 100 Article 26 \u2014 Article 61 Article 27(1) \u2014 Article 102(3) Article 27(2) \u2014 Article 47 Article 27(3) \u2014 Article 68(3) Article 28(1) Article 10 \u2014 Article 28(2) Article 9(3) \u2014 Article 28(3) Article 31(1)(a) (i) and (ii) \u2014 Article 29 \u2014 Article 75 Article 30 \u2014 Article 60 Article 31 \u2014 Article 2(2) Article 32 Article 15 \u2014 Article 33 \u2014 \u2014 Article 34 (2) Article 32(2) and (4) \u2014 Article 35 Article 33 \u2014 Article 36 \u2014 \u2014 Article 37 Article 12 \u2014 Article 38 \u2014 \u2014 Article 39(1) Article 32(6) \u2014 Article 39(2) Article 35(3) \u2014 Article 40(1) Article 6(1) \u2014 Article 41(1) Article 30(1) \u2014 Article 41(2) Article 30(3) and (6) \u2014 Article 41(3) Article 30(3) and (7)(a) \u2014 Article 41(4) \u2014 \u2014 Article 41(5) Article 30(10) \u2014 Article 41(6) \u2014 \u2014 Article 42 Article 31(1)(b) \u2014 Article 43(1) Article 34(1), (2) and (3) \u2014 Article 43(2) \u2014 Article 43(3) Article 34(4) \u2014 Article 44 \u2014 \u2014 Article 45 \u2014 \u2014 Article 46 \u2014 \u2014 Article 47 \u2014 \u2014 Article 48 \u2014 \u2014 Article 49 \u2014 \u2014 Article 50 \u2014 \u2014 Article 51 \u2014 \u2014 Article 52 \u2014 \u2014 Article 53 \u2014 \u2014 Article 54 \u2014 \u2014 Article 55 \u2014 \u2014 Article 56 \u2014 \u2014 Article 57 \u2014 \u2014 Article 57a Article 20 and Annex VII \u2014 Article 58 \u2014 \u2014 Article 59 \u2014 \u2014 Article 60 \u2014 \u2014 Article 61 \u2014 \u2014 Article 62 \u2014 \u2014 Article 63 \u2014 \u2014 Article 64 \u2014 \u2014 Article 65 \u2014 \u2014 Article 66 \u2014 \u2014 Article 67 \u2014 \u2014 Article 68 \u2014 \u2014 Article 69 \u2014 \u2014 Article 70 \u2014 \u2014 Article 71 \u2014 \u2014 Article 72 \u2014 \u2014 Article 73 \u2014 \u2014 Article 74 \u2014 \u2014 Article 75 \u2014 \u2014 Article 76 \u2014 \u2014 Article 77 \u2014 \u2014 Article 78 \u2014 \u2014 Article 79 \u2014 \u2014 Article 80 \u2014 \u2014 Article 81 \u2014 \u2014 Article 82 \u2014 \u2014 Article 83 \u2014 \u2014 Article 84 \u2014 \u2014 Article 85 \u2014 \u2014 Article 86 \u2014 \u2014 Article 87 \u2014 \u2014 Article 88 Article 56 \u2014 Article 89 Article 57 \u2014 Article 90 Article 58 \u2014 Article 91 Article 59 \u2014 Article 92 Article 60 \u2014 Article 93 \u2014 \u2014 Article 94 \u2014 \u2014 Article 95 \u2014 \u2014 Article 96 \u2014 \u2014 Article 97 \u2014 \u2014 Article 98 \u2014 \u2014 Article 99 \u2014 \u2014 Article 100 \u2014 \u2014 Article 101 \u2014 \u2014 Article 102 \u2014 \u2014 Article 103 \u2014 \u2014 Article 104 \u2014 \u2014 Article 105 \u2014 \u2014 Article 106 \u2014 \u2014 Article 107 \u2014 \u2014 Article 108 \u2014 \u2014 Article 109 \u2014 \u2014 Article 110 \u2014 \u2014 Article 111 \u2014 \u2014 Article 112 \u2014 \u2014 Article 113 \u2014 \u2014 Article 114 \u2014 \u2014 Article 115 \u2014 \u2014 Article 116 \u2014 \u2014 Article 117 \u2014 \u2014 Article 118 \u2014 \u2014 Article 119 \u2014 \u2014 Article 120 \u2014 \u2014 Article 121 Articles 16 and 17 \u2014 Article 121a \u2014 Article 98, second subparagraph Article 122 \u2014 \u2014 Article 123 \u2014 \u2014 Article 124(1) to (5), (7) and (8) \u2014 \u2014 Article 124(6) \u2014 Article 98, first subparagraph Article 125 \u2014 \u2014 Article 126 \u2014 \u2014 Article 127 \u2014 \u2014 Article 128 \u2014 \u2014 Article 129 \u2014 \u2014 Article 130 \u2014 \u2014 Article 131 \u2014 \u2014 Article 132 Articles 18 and 19 \u2014 Article 133 \u2014 \u2014 Article 133a Article 37 \u2014 Article 134 (deleted) \u2014 \u2014 Article 135 (deleted) \u2014 \u2014 Article 136 \u2014 \u2014 Article 137 \u2014 \u2014 Article 138 Article 3 \u2014 Article 139 Article 13 \u2014 Article 140 Article 67 \u2014 Article 141 Article 71 \u2014 Article 142(a) to (q) and (s) Article 70 \u2014 Article 142(r) Article 69 \u2014 Article 143 \u2014 \u2014 Article 144 \u2014 \u2014 Article 145 \u2014 \u2014 Article 146 Article 72 \u2014 Article 146a \u2014 \u2014 Article 147 Article 73 \u2014 Article 148 \u2014 \u2014 Article 149 Article 74 \u2014 Annex I Annex I \u2014 Annex II \u2014 Annex II Annex III \u2014 Annex II Annex IV Annex III \u2014 Annex V \u2014 \u2014 Annex VI \u2014 \u2014 Annex VII Annex IV \u2014 Annex VIII Annex II \u2014 Annex IX \u2014 \u2014 Annex X \u2014 \u2014 Annex XI \u2014 \u2014 Annex XII \u2014 \u2014 Annex XIII \u2014 \u2014 Annex XIV \u2014 \u2014 Annex XV \u2014 \u2014 Annex XVI \u2014 \u2014 Annex XVII \u2014 \u2014 Annex XVIIa \u2014 \u2014", "summary": "Rules for direct EU payments to farmers Rules for direct EU payments to farmers SUMMARY OF: Regulation (EU) No 1307/2013 \u2014 rules for direct payments to farmers under the EU\u2019s common agricultural policy WHAT IS THE AIM OF THE REGULATION? It sets out the rules for direct payments made to support farmers under the EU\u2019s common agricultural policy (CAP). These payments are made in full on the condition that farmers meet basic standards concerning the environment, climate change, good agricultural and environmental condition of land, public health, animal health, plant health and animal welfare \u2014 known as cross-compliance. Rules on cross-compliance are laid down in Regulation (EU) No 1306/2013 (see summary). Regulation (EU) No 1307/2013 repeals Regulation (EC) No 73/2009, which contained the previous rules governing direct payments to farmers that changed following the reform of the CAP in 2013. It also repeals Regulation (EC) No 637/2008, which related to the cotton sector. In 2017, the EU adopted Regulation (EU) 2017/2393, which amends Regulation (EU) No 1307/2013 and other legislation relating to the CAP: Regulation (EU) No 1305/2013 setting up the European Agricultural Fund for Rural Development,Regulation (EU) No 1306/2013 laying down financing, managing and monitoring rules for the EU agricultural policy,Regulation (EU) No 1308/2013 on the common organisation of agricultural markets in the EU, andRegulation (EU) No 652/2014 on the management of expenditure relating to the food chain, animal health and animal welfare. In 2020, the EU adopted amending Regulation (EU) 2020/2220, which lays down certain transitional rules for support from the European Agricultural Fund for Rural Development (EAFRD) and from the European Agricultural Guarantee Fund (EAGF) in the years 2021 and 2022. KEY POINTS Direct payments to farmers are paid through support schemes in each EU country. EU countries must dedicate a certain proportion of their CAP funding allocation to compulsory support schemes, as described below. Standard per-hectare payments. To distribute support more fairly, all EU countries had to move towards a uniform payment per hectare from 2015 (a \u2018basic payment for farmers\u2019). Green payments per hectare. To be granted to farmers for observing practices beneficial for the climate and the environment (30% of national funding allocation). Young farmer per-hectare payment. For farmers no more than 40 years old, setting up for the first time as head of their farm, up to 5 years before claiming support; this payment is available for up to 5 years. There are also some optional support schemes. EU countries can choose to: support smaller farms by paying a higher amount on the first hectares (\u2018redistributive payment\u2019); grant additional payments for areas with natural constraints; grant limited amounts of production-related support ('coupled support' \u2014 payments linked to specific crops or types of livestock) to help agricultural sectors in their own country that are in difficulty; offer a simplified scheme for small farmers \u2014 an annual payment of up to \u20ac1,250. From 1 January 2018, the new rules contained in amending Regulation (EU) 2017/2393 came into force and include the following. In principle, only active farmers (meaning those whose agricultural activity is not insignificant) could be granted direct support. However, in some EU countries, the administration became too burdensome. In particular, claimants operating airports, railway services, waterworks, real-estate services and permanent sport and recreational grounds were considered inactive except if they proved otherwise. The application of that clause has become voluntary for EU countries. Some aspects of the rules applying to green payments have been simplified, especially for crop-diversification requirements. An extension of the permanent grassland definition: EU countries may decide to include certain shrubs or trees that produce animal feed in permanent grassland where grasses and other herbaceous forage remain predominant, in the whole or part of their territory;they may consider land not ploughed up or used for crop rotation for 5 years or more as a criterion for the classification of permanent grassland. Young farmers are able to more easily access all 5 years of payments. EU countries\u2019 responsibilities in regard to the production-limiting nature of coupled support are clarified. The types of areas of ecological interest for green payments (ecological focus areas) are extended to cover areas on which plant varieties such as Miscanthus and Silphium perfoliatum are grown, and also to land lying fallow for plants that are beneficial for pollinators. Transitional rules for the years 2021 and 2022 Amending Regulation (EU) 2020/2220, adopted in December 2020, allows for the continued application of the rules under the 2014-2020 CAP framework and ensures the continuity of payments to farmers and other beneficiaries of support from the EAGF and the EAFRD in 2021 and 2022, until the date of application of the new framework. The aim of the transitional period is to facilitate a smooth transition for beneficiaries to a new programming period. FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) No 1307/2013 has applied since 1 January 2015. The rules introduced by amending Regulation (EU) 2017/2393 have applied since 1 January 2018. The rules introduced by amending Regulation (EU) 2020/2220 have applied since 1 January 2021. BACKGROUND For more information, see: The common agricultural policy at a glance \u2014 The future of the CAP (European Commission) Income support explained (European Commission). MAIN DOCUMENT Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, pp. 608-670) Successive amendments to Regulation (EU) No 1307/2013 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC (OJ L 189, 27.6.2014, pp. 1-32) See consolidated version. Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, pp. 487-548) See consolidated version. Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, pp. 549-607) See consolidated version. Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, pp. 671-854) See consolidated version. Regulation (EU) No 1310/2013 of the European Parliament and of the Council of 17 December 2013 laying down certain transitional provisions on support for rural development by the European Agricultural Fund for Rural Development (EAFRD), amending Regulation (EU) No 1305/2013 of the European Parliament and of the Council as regards resources and their distribution in respect of the year 2014 and amending Council Regulation (EC) No 73/2009 and Regulations (EU) No 1307/2013, (EU) No 1306/2013 and (EU) No 1308/2013 of the European Parliament and of the Council as regards their application in the year 2014 (OJ L 347, 20.12.2013, pp. 865-883) See consolidated version. last update 03.03.2021"}
{"article": "20.12.2013 EN Official Journal of the European Union L 347/487 REGULATION (EU) No 1305/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 42 and Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the Court of Auditors, Having regard to the opinion of the European Economic and Social Committee, Having regard to the opinion of the Committee of the Regions, Acting in accordance with the ordinary legislative procedure, Whereas: (1) The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions entitled \"The CAP towards 2020: Meeting the food, natural resources and territorial challenges of the future\" set out the potential challenges, objectives and orientations for the common agricultural policy (\"the CAP\") after 2013. In the light of the debate on that Communication, the CAP should be reformed with effect from 1 January 2014. That reform should cover all the main instruments of the CAP, including Council Regulation (EC) No 1698/2005 (1). In view of the scope of the reform, it is appropriate to repeal Regulation (EC) No 1698/2005 and to replace it with a new text. (2) A rural development policy should be established to accompany and complement direct payments and market measures of the CAP and thereby to contribute to that policy's objectives as laid down in the Treaty on the Functioning of the European Union (\"TFEU\"). Such rural development policy should also integrate the major policy objectives set out in the Communication from the Commission of 3 March 2010 entitled \"Europe 2020 - A strategy for smart, sustainable and inclusive growth\" (\"the Europe 2020 Strategy\") and should be coherent with the general objectives for the economic and social cohesion policy, as set out in the TFEU. (3) Since the objective of this Regulation, namely rural development, cannot be sufficiently achieved by the Member States, given the links between rural development and the other instruments of the CAP, the extent of the disparities that exist between the various rural areas and the limits on the financial resources of the Member States in an enlarged Union but can rather, by reason of the multi-annual guarantee of Union finance and by concentrating on its priorities, be better achieved at Union level. the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (\"TEU\"). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (4) To ensure the sustainable development of rural areas, it is necessary to focus on a limited number of core priorities relating to knowledge transfer and innovation in agriculture, forestry and rural areas, to farm viability, to the competitiveness of all types of agriculture in all regions and promoting innovative farm technologies and the sustainable management of forests, to the organisation of the food chain, including the processing and marketing of agricultural products, to animal welfare, to risk management in agriculture, restoring, preserving and enhancing ecosystems that are related to agriculture and forestry, to the promotion of resource efficiency and the shift towards a low carbon economy in the agricultural, food and forestry sectors, and to promoting social inclusion, poverty reduction in and the economic development of rural areas. In doing so, account should be taken of the diversity of the situations that affect rural areas with different characteristics or different categories of potential beneficiaries and of the cross-cutting objectives of innovation, environment and climate change mitigation and adaptation. Mitigation action should relate both to limiting emissions in agriculture and forestry from key activities such as livestock production, fertilizer use and to preserving carbon sinks and enhancing carbon sequestration with regard to land use, land use change and the forestry sector. The Union priority for rural development relating to knowledge transfer and innovation in agriculture, forestry and rural areas should apply horizontally in relation to the other Union priorities for rural development. (5) The Union's priorities for rural development should be pursued in the framework of sustainable development and the Union's promotion of the aim of protecting and improving the environment, as set out in Article 11 TFEU, taking into account the polluter pays principle. The Member States should, provide information on the support for climate change objectives in line with the ambition to devote at least 20 % of the Union budget to this end using a methodology adopted by the Commission. (6) The activities of the European Agricultural Fund for Rural Development (\"the EAFRD\") and the operations to which it contributes should be consistent and compatible with support from other instruments of the CAP. (7) In order to ensure the immediate start and efficient implementation of rural development programmes, support from the EAFRD should be based on the existence of administrative framework conditions that are sound. Member States should therefore assess the applicability and fulfilment of certain ex ante conditionalities. Each Member State should prepare either a national rural development programme for its entire territory or a set of regional programmes or both a national programme and a set of regional programmes. Each programme should identify a strategy for meeting targets in relation to the Union priorities for rural development and a selection of measures. Programming should comply with Union priorities for rural development, whilst at the same time adapting to national contexts and complementing the other Union policies, in particular the agricultural market policy, the cohesion policy and the common fisheries policy. Member States which opt for preparing a set of regional programmes should also be able to prepare a national framework, without a separate budgetary allocation, in order to facilitate co-ordination among the regions in addressing nation-wide challenges. (8) Member States should be able to include in their rural development programmes thematic sub-programmes to address specific needs in areas of particular importance to them. Thematic sub-programmes should concern, among others, young farmers, small farms, mountain areas, the creation of short supply chains, women in rural areas and climate change mitigation and adaptation and biodiversity. Thematic sub-programmes should also be used to provide for the possibility to contribute to the restructuring of agricultural sectors which have a strong impact on the development of rural areas. As a means of increasing the efficient intervention of certain thematic sub-programmes Member States should be allowed to provide for higher support rates for certain operations covered by those thematic sub-programmes. (9) Rural development programmes should identify the needs of the area covered and describe a coherent strategy to meet them in the light of the Union priorities for rural development. That strategy should be based on the setting of targets. The links between the needs identified, the targets set and the choice of measures selected to meet them should be established. Rural development programmes should also contain all the information required to assess their conformity with the requirements of this Regulation. (10) Targets are to be established in rural development programmes against a common set of target indicators for all Member States and where necessary, against programme specific indicators. In order to facilitate this exercise the areas covered by these indicators should be defined, in line with the Union priorities for rural development. Given the horizontal application of the Union priority for rural development relating to knowledge transfer in agriculture and forestry, interventions under this priority are to be considered as instrumental to the target indicators defined for the remaining Union priorities. (11) It is necessary to establish certain rules for programming and revising rural development programmes. A simplified procedure should be provided for revisions that do not affect the strategy of the programmes or the respective Union financial contributions. (12) The evolution and specialisation of agriculture and forestry and the particular challenges faced by micro and small and medium-sized enterprises (\"SMEs\") in rural areas require an appropriate level of technical and economic training as well as an increased capacity to access and exchange knowledge and information including through the diffusion of best agricultural and forestry production practices. Knowledge transfer and information actions should not only take the form of traditional training courses but should also be adapted to the needs of rural actors. Workshops, coaching, demonstration activities, information actions and also short-term farm and forest-exchange schemes and visits should therefore also be supported. The knowledge and information acquired should enable farmers, forest holders, persons engaged in the food sector and rural SMEs to, in particular, enhance their competitiveness and resource efficiency and improve their environmental performance while at the same time contributing to the sustainability of the rural economy. When providing support to SMEs, Member States have the possibility to give priority to SMEs linked to the agriculture and forestry sectors. In order to ensure that knowledge transfer and information actions are effective in delivering these results it should be required that the providers of knowledge transfer services have all the appropriate capabilities. (13) Farm advisory services help farmers, young farmers, forest holders, other land managers and SMEs in rural areas to improve the sustainable management and overall performance of their holding or business. Therefore both the setting up of such services and the use of advice by farmers, young farmers, forest holders, other land managers and SMEs should be encouraged. In order to enhance the quality and effectiveness of the advice offered, provision should be made for the minimum qualifications and regular training of advisors. As provided for in Regulation (EU) No 1306/2013 of the European Parliament and of the Council (2) farm advisory services should help farmers to assess the performance of their agricultural holding and to identify the necessary improvements as regards the statutory management requirements, good agricultural and environmental conditions, agricultural practices beneficial to the climate and the environment set out in Regulation (EU) No 1307/2013 of the European Parliament and of the Council (3) and measures at farm level provided for in the rural development programmes aiming at farm modernisation, competitiveness building, sectoral integration, innovation, market orientation as well as the promotion of entrepreneurship. Farm advisory services should also help farmers to identify the necessary improvements as regards requirements laid down for the implementation of Article 11(3) of Directive 2000/60/EC of the European Parliament and of the Council (4) (\"the Water Framework Directive\"), as well as requirements for the implementation of Article 55 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (5) and Article 14 of Directive 2009/128/EC of the European Parliament and of the Council (6), in particular in relation to the compliance with the general principles of integrated pest management. Where relevant, advice should also cover occupational or safety standards linked to the farm as well as specific advice for farmers setting up for the first time. It should also be possible for advice to cover the setting up by young farmers, the sustainable development of the economic activities of the holding and local processing and marketing issues, linked to the economic, agricultural and environmental performance of the holding or enterprise. Specific advice may also be provided on climate change mitigation and adaptation, biodiversity, the protection of water, the development of short supply chains, organic farming and health aspects of animal husbandry. When providing support to SMEs, Member States have the possibility to give priority to SMEs linked to the agriculture and forestry sectors. Farm management and farm relief services should help farmers improve and facilitate management of their holding. (14) Union or national quality schemes, including farm certification schemes for agricultural products and food, provide consumers with assurances on the quality and characteristics of the product or the production process used as a result of the participation of farmers in such schemes, achieve added value for the products concerned and enhance their market opportunities. Farmers and groups of farmers should therefore be encouraged to participate in those schemes. In order to ensure the effective use of EAFRD resources, support should be limited to active farmers within the meaning of Article 9 of Regulation (EU) No 1307/2013. As it is at the moment of entering into such schemes and in the early years of participation that additional costs and obligations imposed on farmers as a result of their participation are not fully remunerated by the market, support should be provided for new participation and should cover a period of no more than five years. Given the special characteristics of cotton as a farm product, quality schemes for cotton should also be covered. Support should also be made available for information and promotion activities concerning products covered by the quality and certification schemes receiving support pursuant to this Regulation. (15) In order to improve the economic and environmental performance of agricultural holdings and rural enterprises, to improve the efficiency of the agricultural products marketing and processing sector, including the setting up of small scale processing and marketing facilities in the context of short supply chains and local markets, to provide infrastructure needed for the development of agriculture and forestry and to support non-remunerative investments necessary to achieve environmental aims, support should be provided for physical investments contributing to these aims. During the 2007-2013 programming period a variety of measures covered different areas of intervention. In the interest of simplification, but also of allowing beneficiaries to design and realise integrated projects with increased added value, a single measure should cover most types of physical investments. Member States should direct the support to farms eligible for aid for investments related to supporting farm viability based on the results of the strengths, weaknesses, opportunities and threats (\"SWOT\") analysis as a means of better targeting that aid. In order to facilitate the setting up by young farmers for the first time an additional period of eligibility for investments to comply with Union standards can be granted. In order to foster the implementation of new Union standards, investments related to compliance with those standards should be eligible for an additional period after they have become mandatory for the agricultural holding. (16) The agricultural sector, more than other sectors, is subject to damage to its productive potential caused by natural disasters, adverse climatic events and catastrophic events. In order to help farm viability and competitiveness in the face of such disasters or events, support should be provided to help farmers restore agricultural potential which has been damaged. Member States should also ensure that no overcompensation of damages occurs as a result of the combination of Union (in particular the risk management measure under this Regulation), national and private compensation schemes. (17) For the development of rural areas, the creation and development of new economic activity in the form of new farms, the diversification into non-agricultural activities including the provision of services to agriculture and forestry, activities related to health care, social integration and tourist activities are essential. It is also possible for diversification into non-agricultural activities to address the sustainable management of cynegetic resources. A farm and business development measure should facilitate the initial establishment of young farmers and the structural adjustment of their agricultural holding after the initial setting up. Furthermore, diversification of farmers into non-agricultural activities and the setting up and development of non-agricultural SMEs in rural areas should be promoted. That measure should also encourage entrepreneurship of women in rural areas. The development of small farms, which are potentially economically viable should also be encouraged. In order to ensure the viability of new economic activities supported under that measure, support should be made conditional on the submission of a business plan. Support for a business start up should cover only the initial period of the life of such a business and should not become an operating aid. Therefore, where Member States opt to grant aid in instalments, such instalments should be made over a period of no more than five years. In addition, in order to encourage the restructuring of the agricultural sector, support, in the form of annual or one-off payments, should be provided for farmers eligible for the small farmers scheme established by Title V of Regulation (EU) No 1307/2013 (\"the small farmer's scheme\") who commit to transfer their entire holding and the corresponding payment entitlements to another farmer. In order to address problems of young farmers related to access to land Member States are also able to offer this support in combination with other forms of support, for example, through the use of financial instruments. (18) SMEs are the backbone of the rural economy of the Union. Farm and non-agricultural business development should be aimed at employment promotion and the setting up of quality jobs in rural areas, the maintenance of existing jobs, the reduction of seasonality fluctuations in employment, the development of non-agricultural sectors outside agriculture and agricultural and food processing. At the same time it should foster business integration and local inter-sectoral links. Projects that bring together agriculture and, rural tourism through the promotion of sustainable and responsible tourism in rural areas, and natural and cultural heritage should be encouraged as well as renewable energy investments. (19) The development of local infrastructure and local basic services in rural areas, including leisure and culture services, the renewal of villages and activities aimed at the restoration and upgrading of the cultural and natural heritage of villages and rural landscapes is an essential element of any effort to realise the growth potential and to promote the sustainability of rural areas. Support should therefore be granted to operations with that aim, including access to Information and Communication Technologies and the development of fast and ultra-fast broadband. In line with those objectives, the development of services and infrastructure leading to social inclusion and reversing trends of social and economic decline and depopulation of rural areas should be encouraged. In order to achieve the maximum effectiveness of such support, covered operations should be implemented in accordance with plans for the development of municipalities and their basic services, where such plans exist, elaborated by one or more rural communes. In order to create synergies and to improve co-operation, operations should also, where relevant, promote rural-urban links. Member States have the possibility to give priority to investments by community-led local development partnerships, and to projects managed by local community organisations. (20) Forestry is an integral part of rural development and support for sustainable and climate friendly land use should include forest area development and sustainable management of forests. During the 2007-2013 programming period, a variety of measures covered different types of support for forestry investments and management. In the interests of simplification and of allowing beneficiaries to design and realise integrated projects with increased added value, a single measure should cover all types of support for forestry investments and management. That measure should cover the extension and improvement of forest resources through the afforestation of land and the creation of agroforestry systems combining extensive agriculture with forestry systems. It should also cover the restoration of forests damaged by fire or other natural disasters and catastrophic events and relevant prevention measures; investments in forestry technologies and in the processing; the mobilising and marketing of forest products aimed at improving the economic and environmental performance of forest holders; and non- remunerative investments which improve ecosystem and climate resilience and environmental value of forest ecosystems. Support should not distort competition and should be market neutral. As a result, limitations relating to the size and legal status of beneficiaries should be imposed. Preventive actions against fires should be undertaken in areas classified by Member States as medium or high fire risk. All preventive actions should be part of a forest protection plan. In the case of an action undertaken for the restoration of damaged forest potential, the occurrence of a natural disaster should be subject to formal recognition by a scientific public organisation. The forestry measure should be adopted in the light of undertakings given by the Union and Member States at international level, and should be based on Member States' national or sub-national forest plans or equivalent instruments which should take into account the commitments made in the Ministerial Conferences on the Protection of Forests in Europe. It should contribute to the implementation of the Union Forest Strategy in line with the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions entitled \"A new EU Forest Strategy: for forests and the forest-based sector\". (21) Producer groups and organisations help farmers to face together the challenges posed by increased competition and consolidation of downstream markets in relation to the marketing of their products including in local markets. The setting up of producer groups and organisations should therefore be encouraged. In order to ensure the best use of limited financial resources only producer groups and organisations that qualify as SMEs should benefit from support. Member States have the possibility to give priority to producer groups and organisations of quality products covered by the measure on quality schemes for agricultural products and foodstuffs in this Regulation. In order to ensure that the producer group or organisation becomes a viable entity, a business plan should be submitted to the Member States, as a condition for granting support to a producer group or organisation. In order to avoid providing operating aid and in order to maintain the incentive role of the support, the maximum duration of the support should be limited to five years from the date of recognition of the producer group or organisation on the basis of its business plan. (22) Agri-environment-climate payments should continue to play a prominent role in supporting the sustainable development of rural areas and in responding to society's increasing demands for environmental services. They should further encourage farmers and other land managers to serve society as a whole by introducing or continuing to apply agricultural practices that contribute to climate change mitigation and adaptation and that are compatible with the protection and improvement of the environment, the landscape and its features, natural resources, and the soil and genetic diversity. In that context the conservation of genetic resources in agriculture and the additional needs of farming systems that are of high nature value should be given specific attention. Payments should contribute to covering additional costs and income foregone resulting from the commitments undertaken and should only cover commitments going beyond relevant mandatory standards and requirements, in accordance with the \"polluter pays principle\". Member States should also ensure that payments to farmers do not lead to double funding under this Regulation and Regulation (EU) No 1307/2013. In many situations the synergies resulting from commitments undertaken jointly by a group of farmers multiply the environmental and climate benefit. However, joint actions involve additional transaction costs which should be compensated adequately. In addition, in order to ensure that farmers and other land managers are in a position to correctly implement the commitments they have undertaken, Member States should endeavour to provide them with the required skills and knowledge. Member States should maintain the level of efforts made during the 2007-2013 programming period and should be required to spend a minimum of 30 % of the total contribution from the EAFRD to each rural development programme on climate change mitigation and adaptation as well as environmental issues. Such spending should be made through agri-environment-climate and organic farming payments and payments to areas facing natural or other specific constraints, through payments for forestry, payments for Natura 2000 areas and climate and environment-related investment support. (23) Payments to farmers for the converting to, or maintaining, organic farming should encourage them to participate in such schemes thereby responding to the increasing demand of society for the use of environmentally friendly farm practices and for high standards of animal welfare. In order to increase synergy in biodiversity, benefits delivered by the organic farming measure, collective contracts or co-operation between farmers should be encouraged to cover larger, adjacent areas. In order to avoid a large-scale return by farmers to conventional farming support should be given to both conversion and maintenance measures. Payments should contribute to covering additional costs incurred and income foregone as a result of the commitment and should cover only commitments that go beyond relevant mandatory standards and requirements. Member States should also ensure that payments to farmers do not lead to double funding under this Regulation and Regulation (EU) No 1307/2013 (DP). In order to ensure the effective use of EAFRD resources, support should be limited to active farmers within the meaning of Article 9 of Regulation (EU) No 1307/2013. (24) Support should continue to be granted to farmers and forest holders to help address specific disadvantages in the areas concerned resulting from the implementation of Directive 2009/147/EC of the European Parliament and of the Council (7) and Council Directive 92/43/EEC (8) and in order to contribute to the effective management of Natura 2000 sites. Support should also be made available to farmers to help address disadvantages in river basin areas resulting from the implementation of the Water Framework Directive. Support should be linked to specific requirements described in the rural development programme that go beyond relevant mandatory standards and requirements. Member States should also ensure that payments to farmers do not lead to double funding under this Regulation and Regulation (EU) No 1307/2013. Furthermore, the specific needs of Natura 2000 areas should be taken into account by Member States in the overall design of their rural development programmes. (25) Payments to farmers in mountain areas or in other areas facing natural or other specific constraints should, by encouraging continued use of agricultural land, contribute to maintaining the countryside as well as to maintaining and promoting sustainable farming systems. In order to ensure the efficiency of such support, payments should compensate farmers for income foregone and additional costs linked to the disadvantage of the area concerned. In order to ensure the effective use of EAFRD resources, support should be limited to active farmers within the meaning of Article 9 of Regulation (EU) No 1307/2013. (26) In order to ensure the efficient use of Union funds and equal treatment for farmers across the Union, mountain areas and areas facing natural or other specific constraints should be defined in accordance with objective criteria. In the case of areas facing natural constraints, those criteria should be bio-physical and underpinned by robust scientific evidence. Transitional arrangements should be adopted in order to facilitate the phasing-out of payments in areas that, as a result of the application of these criteria, will no longer be considered to be areas facing natural constraints. (27) Farmers should continue to be encouraged to adopt high standards of animal welfare by providing support for farmers who undertake to adopt standards of animal husbandry, which go beyond the relevant mandatory standards. In order to ensure the effective use of EAFRD resources, support should be limited to active farmers within the meaning of Article 9 of Regulation (EU) 1307/2013. (28) Payments should continue to be granted to forest holders who provide environment-friendly or climate-friendly forest conservation services by undertaking commitments to enhance biodiversity, preserve high-value forest ecosystems, improve their climate change mitigation and adaptation potential, and reinforce the protective value of forests with respect to soil erosion, maintenance of water resources and natural hazards. In that context, specific attention should be paid to the conservation and promotion of forest genetic resources. Payments should be granted for forest environmental commitments going beyond relevant mandatory standards established by national law. (29) During the 2007-2013 programming period the only type of co-operation which was explicitly supported under rural development policy was co-operation for the development of new products, processes and technologies in the agriculture and food sector and the forestry sector. Support for that type of co-operation is still necessary but should be adapted in order to better meet the requirements of the knowledge economy. In that context, there should be the possibility for projects by a single operator to be financed under that measure, on condition that the results obtained are disseminated, thus achieving the aim of diffusing new practices, processes or products. In addition, it has become clear that supporting a much broader range of types of co-operation, with a wider range of beneficiaries, from smaller operators to larger ones, can contribute to achieving the objectives of rural development policy by helping operators in rural areas overcome the economic, environmental and other disadvantages of fragmentation. Therefore, that measure should be widened. Support to small operators for organising joint work processes and sharing facilities and resources should help them to be economically viable despite their small scale. Support for horizontal and vertical co-operation among actors in the supply chain, as well as for promotion activities in a local context, should catalyse the economically rational development of short supply chains, local markets and local food chains. Support for joint approaches to environmental projects and practices should help to produce greater and more consistent environmental and climate benefits than those which can be delivered by individual operators acting without reference to others (for example, through practices applied on larger, unbroken areas of land). Support should be provided in various forms. Clusters and networks are particularly relevant to the sharing of expertise as well as the development of new and specialised expertise, services and products. Pilot projects are important tools for testing the commercial applicability of technologies, techniques and practices in different contexts, and adapting them where necessary. Operational groups are a pivotal element of the European Innovation Partnership (\"EIP\") for agricultural productivity and sustainability. Another important tool lies in local development strategies operating outside the framework of LEADER local development \u2013 between public and private actors from rural and urban areas. Unlike under the LEADER approach, it is possible for such partnerships and strategies to be limited to one sector or to relatively specific development aims, including those mentioned above. Member States have the possibility to give priority to co-operation among entities involving primary producers. Inter-branch organisations should also be eligible for support under this measure. Such support should be limited to a period of seven years except for collective environmental and climate action in duly justified cases. (30) Nowadays, farmers are exposed to increasing economic and environmental risks as a consequence of climate change and increased price volatility. In this context, the effective management of risks has an increased importance for farmers. Consequently, a risk management measure should be set up to assist farmers in addressing the most common risks faced by them. That measure should therefore help farmers to cover the premiums they pay for crop, animal and plant insurance as well as help with the setting up of mutual funds and the compensation paid by such funds to farmers for losses suffered as a result of adverse climatic events, the outbreak of animal or plant diseases, pest infestation or environmental incidents. It should also include an income stabilisation tool in the form of a mutual fund to support farmers facing a severe drop in their incomes. In order to ensure that farmers receive equal treatment across the Union, that competition is not distorted and that the international obligations of the Union are respected, specific conditions should be provided for the granting of support under these measures. In order to ensure the effective use of EAFRD resources, support should be limited to active farmers within the meaning of Article 9 of Regulation (EU) No 1307/2013. (31) The LEADER approach for local development has, over a number of years, proven its effectiveness in promoting the development of rural areas by fully taking into account the multi-sectoral needs for endogenous rural development through its bottom-up approach. LEADER should therefore be continued in the future and its application should remain compulsory for rural development programmes at national and/or regional level. (32) Support for LEADER local development from the EAFRD should also cover inter-territorial co-operation projects between groups within a Member State or transnational co-operation projects between groups in several Member States or co-operation projects between groups in Member States and in third countries. (33) In order to enable partners in rural areas who do not yet apply LEADER to test and prepare for the design and implementation of a local development strategy, a \"LEADER start-up kit\" should also be financed. Support should not be conditional on the submission of a local development strategy. (34) Investments are common to many of the rural development measures under this Regulation and may relate to operations of a very diverse nature. In order to ensure clarity in the implementation of those operations certain common rules for all investments should be laid down. Those common rules should define the types of expenditure that may be considered to be investment expenditure and should ensure that only such investments that create new value in agriculture receive support. In order to facilitate the implementation of investment projects Member States should have the possibility to pay advances. To ensure the effectiveness, fairness and sustainable impact of EAFRD assistance, rules should be laid down to ensure that investments related to operations are durable and that EAFRD support is not used to distort competition. (35) It should be possible for the EAFRD to support investments in irrigation to provide economic and environmental benefits, provided that the sustainability of the irrigation concerned is ensured. Consequently, in every case, support should be granted only if a river basin management plan is in place in the area concerned as required by the Water Framework Directive, and if there is already water metering in place at the level of the investment or it is put in place as part of the investment. Investments in improvements to existing irrigation infrastructure or equipment should lead to a minimum gain in terms of water efficiency, expressed as a potential water saving. If the water body affected by the investment is under stress for reasons related to water quantity as set out in the analytical framework established by the Water Framework Directive, half of the gain in terms of water efficiency should be translated into a real reduction in water use at the level of the supported investment, in order to reduce the stress on the water body concerned. Certain cases should be set out in which it is not possible or necessary for the requirements of potential or effective water savings to apply, including those concerning investments in recycling or re-using water. In addition to supporting investments in improvements to existing equipment provision should be made for the EAFRD to support investments in new irrigation subject to the findings of an environmental analysis. With certain exceptions, support should, however, not be granted for new irrigation where the affected water body is already under stress, in view of the very high risk that granting support in such circumstances would worsen existing environmental problems. (36) Certain area-related measures under this Regulation require beneficiaries to undertake commitments for at least five years. During that period, it is possible that changes occur to the situation of either the holding or of the beneficiary. Rules should therefore be laid down in order to determine what should happen in such cases. (37) Certain measures under this Regulation make support conditional upon beneficiaries undertake commitments that go beyond a relevant baseline defined in terms of mandatory standards or requirements. In view of possible changes to the law during the period of the commitments resulting in the modification of the baseline, provision should be made the contracts concerned to be revised in order to ensure continued compliance with that condition. (38) In order to ensure that financial resources for rural development are used in the best possible way and to target measures under rural development programmes in accordance with the Union priorities for rural development and in order to guarantee equal treatment of applicants, Member States should establish selection criteria for the selection of projects. Exception to this rule should be made only for payments under agri-environmental-climate, organic farming, Natura 2000 and the Water Framework Directive, areas facing natural or other specific constraints, animal welfare, forest-environmental and climate services and risk management related measures. When applying the selection criteria the size of the operation should be taken into account in accordance with the principle of proportionality. (39) The EAFRD should support, through technical assistance, actions relating to the implementation of rural development programmes, including the costs related to the protection of symbols and abbreviations relating to Union quality schemes for participation in which support may be granted under this Regulation and costs of the Member States for the delimitation of areas facing natural constraints. (40) The networking of national networks, organisations and administrations involved in the various stages of programme implementation, organised in the context of the European network for rural development, has proven that it can play a very important role in improving the quality of rural development programmes by increasing the involvement of stakeholders in the governance of rural development as well as in informing the broader public of its benefits. It should, therefore, be financed as part of technical assistance at Union level. To take account of the specific needs of evaluation, a European evaluation capacity for rural development should be set up as part of the European network for rural development in order to bring together all actors involved and thereby to facilitate the exchange of expertise in the field. (41) The EIP for agricultural productivity and sustainability should contribute to the achievement of the Europe 2020 objectives of smart, sustainable and inclusive growth. It is important that it brings together all relevant actors at Union, national and regional levels, presenting new ideas to Member States on how to streamline, simplify and better coordinate existing instruments and initiatives and complement them with new actions where necessary. (42) In order to contribute to the achievement of the aims of the EIP for agricultural productivity and sustainability a EIP network should be set up in order to network operational groups, advisory services and researchers involved in the implementation of actions targeting innovation in agriculture. It should be financed as part of technical assistance at Union level. (43) Member States should reserve a portion of the total amount of each rural development programme devoted to technical assistance in order to finance the setting up and operation of a national rural network that brings together organisations and administrations involved in rural development, including the EIP, with the aim of increasing their involvement in the implementation of the programme and improving the quality of rural development programmes. To this end, national rural networks should prepare and implement an action plan. (44) Rural development programmes should provide for innovative actions promoting a resource-efficient, productive and low-emission agricultural sector, with the support of the EIP for agricultural productivity and sustainability. The EIP should aim to promote a faster and wider transposition of innovative solutions into practice. The EIP should create added value by enhancing the uptake and effectiveness of innovation-related instruments and enhancing synergies between them. The EIP should fill gaps by better linking research and practical farming. (45) The implementation of innovative projects in the context of the EIP for agricultural productivity and sustainability should be undertaken by operational groups that bring together farmers, forest managers, rural communities, researchers, NGOs advisors, businesses and other actors concerned by innovation in the agricultural sector. In order to ensure that the results of such projects benefit the sector as a whole, those results in the field of innovation and knowledge exchanges within the Union and with third countries should be disseminated. (46) Provision should be made for the determination of the total amount of Union support for rural development under this Regulation for the period from 1 January 2014 to 31 December 2020, in accordance with the Multi-annual Financial Framework for the period 2014 to 2020. The appropriations available should be indexed on a flat-rate basis for programming. (47) In order to facilitate the management of EAFRD funds, a single contribution rate for support from the EAFRD to rural development programming should be set in relation to public expenditure in the Member States. In order to take account of their particular importance or nature, specific contribution rates should be set in relation to certain types of operations. In order to mitigate the specific constraints resulting from the level of development the remoteness and insularity, an appropriate EAFRD contribution rate should be set for less developed regions, the outermost regions referred to in the TFEU and the smaller Aegean islands, as well as transition regions. (48) Member States should take all steps necessary to ensure that their rural development measures are verifiable and controllable, including putting in place adequate provisions. To that end, the Managing Authority and Paying Agency should provide an ex ante assessment and undertake to assess measures throughout the implementation of the programme. Measures that do not comply with that condition should be adjusted. (49) The Commission and Member States should take all steps necessary to ensure the sound management of rural development programmes. In this context the Commission should carry out adequate measures and controls and the Member States should take measures to guarantee the sound functioning of their management systems. (50) A single Managing Authority should be responsible for the management and implementation of each rural development programme. Its duties should be specified in this Regulation. The Managing Authority should be able to delegate part of its duties whilst retaining responsibility for the efficiency and correctness of management. Where a rural development programme contains thematic sub-programmes the Managing Authority should be able to designate another body to carry out the management and implementation of that sub-programme in relation to the financial allocations that have been identified for it in the programme whilst ensuring sound financial management of those sub-programmes. Where a Member State has more than one programme to manage, a coordination body can be set up to ensure consistency. (51) Each rural development programme should be subject to regular monitoring of the implementation of the programme and of progress towards the established targets of the programme. Since demonstrating and improving the impact and effectiveness of actions under the EAFRD also depends on appropriate evaluation during the preparation and implementation of a programme and its completion, a monitoring and evaluation system should be set up jointly by the Commission and the Member States with the purpose of demonstrating the progress and assessing the impact and efficiency of rural development policy implementation. (52) In order to ensure that information can be aggregated at Union level, a set of common indicators should form part of that monitoring and evaluation system. Key information on the implementation of rural development programmes should be recorded and maintained electronically as a means to facilitate data aggregation. Beneficiaries should therefore be required to provide the minimum necessary information that is needed for monitoring and evaluation. (53) The responsibility for monitoring the programme should be shared between the Managing Authority and a Monitoring Committee set up for that purpose. The Monitoring Committee should be responsible for the monitoring of the effectiveness of the implementation of the programme. To that end, its responsibilities should be specified. (54) The monitoring of the programme should involve the drawing up of an annual implementation report to be sent to the Commission. (55) In order to improve its quality and demonstrate its achievements, each rural development programme should be subject to evaluation. (56) Articles 107, 108 and 109 TFEU should apply to the support for the rural development measures under this Regulation. Nevertheless, given the specific characteristics of the agricultural sector, those TFEU provisions should not apply to rural development measures concerning operations falling within the scope of Article 42 TFEU, that are carried out under and in conformity with this Regulation or to payments made by Member States, intended to provide additional national financing for rural development operations for which Union support is granted and which fall within the scope of Article 42 TFEU. (57) Moreover, with a view to ensuring consistency with the rural development measures eligible for Union support and in order to simplify procedures, payments made by the Member States, intended to provide additional national financing for rural development operations for which Union support is granted and which fall within the scope of Article 42 TFEU, should be included in the rural development programme for assessment and approval in accordance with the provisions of this Regulation. In order to ensure that additional national financing is not implemented unless it has been authorised by the Commission, the Member State concerned should be precluded from putting its proposed additional financing for rural development into effect until it has been approved. Payments made by Member States intended to provide additional national financing for rural development operations for which Union support is granted and which fall outside the scope of Article 42 TFEU should be notified to the Commission pursuant to Article 108(3) TFEU, unless they fall under a regulation, adopted pursuant to Council Regulation 994/98 (9), and Member States should be precluded from putting them into effect until that notification procedure has resulted in a final approval by the Commission. (58) In order to provide an efficient and secure exchange of data of common interest as well as to record, maintain and manage key information and report on monitoring and evaluation, an electronic information system should be established. (59) Union law on the protection of individuals with regard to the processing of personal data and on the free movement of such data, in particular Directive 95/46/EC of the European Parliament and of the Council (10) and Regulation (EC) No 45/2001 of the European Parliament and of the Council (11) should apply. (60) In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (61) That empowerment should cover: the conditions under which a legal person is considered to be a young farmer and the setting of a period of grace for the acquisition of skills; the duration and content of farm and forest exchange schemes and farm and forest visits. It should also cover: the specific Union schemes under Article 17(1)(a) and the characteristics of groups of producers and types of actions that may receive support under paragraph 2 of Article 17, as well as the setting of conditions to prevent distortion of competition to prevent discrimination against products and to exclude commercial brands from support. (62) In addition, that empowerment should cover: the minimum content of business plans and the criteria to be used by Member states for setting the thresholds referred to in Article 19(4); the definition and the minimum environmental requirements for afforestation and the creation of woodland; the conditions applicable to agri-environment-climate commitments to extensify livestock farming, rear local breeds in danger of being lost to farming or preserve plant genetic resources under threat of genetic erosion, as well as the definition of eligible operations for the conservation and for the sustainable use and development of genetic resources. It should also cover: the calculation method to be used in order to avoid double funding of the practices referred to in Article 43 of Regulation (EU) No 1307/2013 for the agri-environment-climate, organic farming, measures under Natura 2000 and measures under the Water Framework Directive; the definition of the areas in which animal welfare commitments shall provide upgraded standards of production methods; the type of operations eligible for support under the conservation and promotion of forest genetic resources; the specification of the characteristics of pilot projects, clusters, networks, short supply chains and local markets that will be eligible for support under the co-operation measure, as well as the conditions for granting aid to the types of operation listed under that measure. (63) Furthermore, that empowerment should cover: the minimum and maximum duration of commercial loans to mutual funds under the risk management measure under this Regulation; the conditions under which costs related to leasing contracts or second hand equipment may be considered as eligible investment expenditure, as well as the definition of types of renewable energy infrastructure eligible for investment; the conditions applicable to conversion or adjustment of commitments under the measures referred to in Articles 28, 29, 33 and 34, as well as the definition of other situations in which reimbursement of the aid shall not be required. It should also cover: the review of the ceilings set out in Annex I; the conditions under which support approved by the Commission under Regulation (EC) No 1698/2005 may be integrated into support provided for under this Regulation, including for technical assistance and for the ex-post evaluations, in order to facilitate a smooth transition from the system established by Regulation (EC) No 1698/2005 to the system established by this Regulation. In order to take account of the Treaty of Accession of the Republic of Croatia those delegated acts should also cover, for Croatia, the transition from support for rural development under Council Regulation (EC) No 1085/2006 (12), where necessary. (64) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission, in relation to the content of rural development programmes and national frameworks, the approval of programmes and of modifications thereto, the procedures and timetables for approval of programmes, the procedures and timetables for the approval of modifications to programmes and to national frameworks, including their entry in to force and frequency of submission, the rules on payment methods for participants' costs for knowledge transfer and information actions, specific conditions for the implementation of rural development measures, the structure and operation of networks set up by this Regulation, the information and publicity requirements, the adoption of the monitoring and evaluation system and the rules for the operation of the information system, and the rules concerning the presentation of the annual implementation reports. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and the Council (13). (65) The European Data Protection Supervisor was consulted and adopted an opinion on 14 December 2011 (14). (66) Due to the urgency of preparing the smooth implementation of the measures envisaged, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union. (67) The new support scheme provided for by this Regulation replaces the support scheme set up by Regulation (EC) No 1698/2005. Regulation (EC) No 1698/2005 should therefore be repealed, HAVE ADOPTED THIS REGULATION: TITLE I OBJECTIVES AND STRATEGY CHAPTER I Subject matter and Definitions Article 1 Subject matter 1. This Regulation lays down general rules governing Union support for rural development, financed by the European Agricultural Fund for Rural Development (\"the EAFRD\") and established by Regulation (EU) No 1306/2013. It sets out the objectives to which rural development policy is to contribute and the relevant Union priorities for rural development. It outlines the strategic context for rural development policy and defines the measures to be adopted in order to implement rural development policy. In addition, it lays down rules on programming, networking, management, monitoring and evaluation on the basis of responsibilities shared between the Member States and the Commission and rules to ensure coordination of the EAFRD with other Union instruments. 2. This Regulation complements the provisions of Part Two of Regulation (EU) No 1303/2013 of the European Parliament and the Council (15). Article 2 Definitions 1. For the purposes of this Regulation, the definitions of \"programme\", \"operation\", \"beneficiary\", \"community-led local development strategy\", \"public expenditure\", \"SMEs\", \"completed operation\" and \"financial instruments\" as laid down or referred to in Article 2 and of \"less developed regions\" and \"transition regions\" as laid down in points (a) and (b) in Article 90(2) of Regulation (EU) No 1303/2013 apply. In addition, the following definitions shall apply: (a) \"programming\": means the process of organisation, decision making and allocation of financial resources in several stages, with the involvement of partners, intended to implement, on a multi-annual basis, joint action by the Union and the Member States to achieve the Union priorities for rural development. (b) \"region\" means a territorial unit corresponding to level 1 or 2 of the Nomenclature of territorial units for statistics (NUTS level 1 and 2) within the meaning of Regulation (EC) No 1059/2003 of the European Parliament and of the Council (16); (c) \"measure\" means a set of operations contributing to one or more of the Union priorities for rural development; (d) \"support rate\" means the rate of public contribution to an operation; (e) \"transaction cost\" means an additional cost linked to fulfilling a commitment, but not directly attributable to its implementation or not included in the costs or income foregone that are compensated directly; and which can be calculated on a standard cost basis; (f) \"agricultural area\" means any area taken up by arable land, permanent grassland and permanent pasture or permanent crops as defined in Article 4 of Regulation (EU) No 1307/2013; (g) \"economic losses\" means any additional cost incurred by a farmer as a result of exceptional measures taken by the farmer with the objective of reducing supply on the market concerned or any substantial loss of production; (h) \"adverse climatic event\" means weather conditions, such as frost, storms and hail, ice, heavy rain or severe drought, which can be assimilated to a natural disaster; (i) \"animal diseases\" means diseases mentioned in the list of animal diseases established by the World Organisation for Animal Health or in the Annex to Council Decision 2009/470/EC (17); (j) \"environmental incident\" means a specific occurrence of pollution, contamination or degradation in the quality of the environment which is related to a specific event and is of limited geographical scope; but does not cover general environmental risks not connected with a specific event, such as climate change or atmospheric pollution; (k) \"natural disaster\": means a naturally occurring event of a biotic or abiotic nature that leads to important disturbances in agricultural production systems or forest structures, eventually causing important economic damage to the farming or forestry sectors; (l) \"catastrophic event\": means an unforeseen event of a biotic or abiotic nature caused by human action that leads to important disturbances in agricultural production systems or forest structures, eventually causing important economic damage to the farming or forestry sectors; (m) \"short supply chain\": means a supply chain involving a limited number of economic operators, committed to co-operation, local economic development, and close geographical and social relations between producers, processors and consumers; (n) \"young farmer\" means a person who is no more than 40 years of age at the moment of submitting the application, possesses adequate occupational skills and competence and is setting up for the first time in an agricultural holding as head of that holding; (o) \"thematic objectives\": means the thematic objectives defined in Article 9 of Regulation (EU) No 1303/2013. (p) \"Common Strategic Framework\" (\"CSF\")\": means the Common Strategic Framework referred to in Article 10 of Regulation (EU) No 1303/2013; (q) \"cluster\" means a grouping of independent undertakings, including start-ups, small, medium and large undertakings as well as advisory bodies and/or research organisations - designed to stimulate economic/ innovative activity by promoting intensive interactions, the sharing of facilities and the exchange of knowledge and expertise, as well as contributing effectively to knowledge transfer, networking and information dissemination among the undertakings in the cluster; (r) \"forest\" means an area of land spanning more than 0,5 hectares with trees higher than 5 meters and a canopy cover of more than 10 percent, or trees able to reach these thresholds in situ; and does not include land that is predominantly under agricultural or urban land use, subject to paragraph 2. 2. A Member State or region may choose to apply a forest definition, other than the one in point (r) of paragraph 1, based on existing national law or inventory system. The Member States or regions shall provide such definition in the rural development programme; 3. In order to ensure a coherent approach in the treatment of beneficiaries and to take into account the need for an adaptation period, as regards the definition of young farmer laid down in paragraph 1(n), the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the conditions under which a legal person may be considered to be a 'young farmer', and the setting of a grace period for the acquisition of occupational skills. CHAPTER II Mission, objectives and priorities Article 3 Mission The EAFRD shall contribute to the Europe 2020 Strategy by promoting sustainable rural development throughout the Union in a manner that complements the other instruments of the CAP, the cohesion policy and the common fisheries policy. It shall contribute to the development of a Union agricultural sector that is more territorially and environmentally balanced, climate-friendly and resilient and competitive and innovative. It shall also contribute to the development of rural territories. Article 4 Objectives Within the overall framework of the CAP, support for rural development, including for activities in the food and non-food sector and in forestry, shall contribute to achieving the following objectives: (a) fostering the competitiveness of agriculture; (b) ensuring the sustainable management of natural resources, and climate action; (c) achieving a balanced territorial development of rural economies and communities including the creation and maintenance of employment. Article 5 Union priorities for rural development The achievement of the objectives of rural development, which contribute to the Europe 2020 strategy for smart, sustainable and inclusive growth, shall be pursued through the following six Union priorities for rural development, which reflect the relevant Thematic Objectives of the CSF: (1) fostering knowledge transfer and innovation in agriculture, forestry, and rural areas with a focus on the following areas: (a) fostering innovation, cooperation, and the development of the knowledge base in rural areas; (b) strengthening the links between agriculture, food production and forestry and research and innovation, including for the purpose of improved environmental management and performance; (c) fostering lifelong learning and vocational training in the agricultural and forestry sectors. (2) enhancing farm viability and competitiveness of all types of agriculture in all regions and promoting innovative farm technologies and the sustainable management of forests, with a focus on the following areas: (a) improving the economic performance of all farms and facilitating farm restructuring and modernisation, notably with a view to increasing market participation and orientation as well as agricultural diversification; (b) facilitating the entry of adequately skilled farmers into the agricultural sector and, in particular, generational renewal. (3) promoting food chain organisation, including processing and marketing of agricultural products, animal welfare and risk management in agriculture, with a focus on the following areas: (a) improving competitiveness of primary producers by better integrating them into the agri-food chain through quality schemes, adding value to agricultural products, promotion in local markets and short supply circuits, producer groups and organisations and inter-branch organisations; (b) supporting farm risk prevention and management. (4) restoring, preserving and enhancing ecosystems related to agriculture and forestry, with a focus on the following areas: (a) restoring, preserving and enhancing biodiversity, including in Natura 2000 areas, and in areas facing natural or other specific constraints, and high nature value farming, as well as the state of European landscapes; (b) improving water management, including fertiliser and pesticide management; (c) preventing soil erosion and improving soil management. (5) promoting resource efficiency and supporting the shift towards a low carbon and climate resilient economy in agriculture, food and forestry sectors, with a focus on the following areas: (a) increasing efficiency in water use by agriculture; (b) increasing efficiency in energy use in agriculture and food processing; (c) facilitating the supply and use of renewable sources of energy, of by-products, wastes and residues and of other non food raw material, for the purposes of the bio-economy; (d) reducing green house gas and ammonia emissions from agriculture; (e) fostering carbon conservation and sequestration in agriculture and forestry; (6) promoting social inclusion, poverty reduction and economic development in rural areas, with a focus on the following areas: (a) facilitating diversification, creation and development of small enterprises, as well as job creation; (b) fostering local development in rural areas; (c) enhancing the accessibility, use and quality of information and communication technologies (ICT) in rural areas. All those priorities shall contribute to the cross-cutting objectives of innovation, environment and climate change mitigation and adaptation. Programmes may address fewer than six priorities if justified on the basis of the analysis of the situation in terms of strengths, weaknesses, opportunities and threats (\"the SWOT\") and the ex ante evaluation. At least four priorities shall be addressed by each programme. When a Member State submits a national programme and a set of regional programmes, the national programme may address fewer than four priorities. Other focus areas may be included in programmes in order to pursue one of the priorities if justified and measurable. TITLE II PROGRAMMING CHAPTER I Programming content Article 6 Rural development programmes 1. The EAFRD shall act in the Member States through rural development programmes. Those programmes shall implement a strategy to meet the Union priorities for rural development through a set of measures as defined in Title III. Support from the EAFRD shall be sought for the achievement of the objectives of rural development pursued through Union priorities. 2. A Member State may submit either a single programme for its entire territory or a set of regional programmes. Alternatively, in duly justified cases, it may submit a national programme and a set of regional programmes. If a Member State submits a national programme and a set of regional programmes, measures and/or types of operations shall be programmed either at national level or at regional level, and coherence between the strategies of the national and regional programmes shall be ensured. 3. Member States with regional programmes may also submit, for approval in accordance with Article 10(2), a national framework containing common elements for these programmes without a separate budgetary allocation. National frameworks of Member States with regional programmes may also contain a table summarising, by region and by year, the total EAFRD contribution to the Member State concerned for the whole programming period. Article 7 Thematic sub-programmes 1. With the aim of contributing to the achievement of the Union priorities for rural development, Member States may include within their rural development programmes thematic sub-programmes that address specific needs. Such thematic sub-programmes may, inter alia, relate to: (a) young farmers; (b) small farms as referred to in the third subparagraph of Article 19(2); (c) mountain areas as referred to in Article 32(2); (d) short supply chains; (e) women in rural areas; (f) climate change mitigation and adaptation and biodiversity. An indicative list of measures and types of operations of particular relevance to each thematic sub-programme is set out in Annex IV. 2. Thematic sub-programmes may also address specific needs relating to the restructuring of agricultural sectors with a significant impact on the development of a specific rural area. 3. The support rates laid down in Annex II may be increased by 10 additional percentage points for operations supported in the framework of thematic sub-programmes concerning small farms and short supply chains, climate change mitigation and adaptation and biodiversity. In the case of young farmers and mountain areas, the maximum support rates may be increased in accordance with Annex II. However, the maximum combined support rate shall not exceed 90 %. Article 8 Content of rural development programmes 1. In addition to the elements referred to in Article 27 of Regulation (EU) No 1303/2013, each rural development programme shall include: (a) the ex ante evaluation referred to in Article 55 of Regulation (EU) No 1303/2013; (b) a SWOT analysis of the situation and an identification of the needs that have to be addressed in the geographical area covered by the programme. The analysis shall be structured around the Union priorities for rural development. Specific needs concerning the environment, climate change mitigation and adaptation and innovation shall be assessed across Union priorities for rural development, in order to identify relevant responses in these three areas at the level of each priority; (c) a description of the strategy which demonstrates that: (i) appropriate targets are set for each of the focus areas of the Union priorities for rural development included in the programme, based on the common indicators referred to in Article 69 and, where necessary, on programme specific indicators; (ii) relevant combinations of measures are selected in relation to each of the focus areas of the Union priorities for rural development included in the programme, based on a sound intervention logic supported by the ex ante evaluation referred to in point (a) and the analysis referred to in point (b); (iii) the allocation of financial resources to the measures of the programme is justified and adequate to achieve the targets set; (iv) specific needs linked with specific conditions at regional or sub-regional level are taken into account and concretely addressed through adequately designed combinations of measures or thematic sub-programmes; (v) an appropriate approach towards innovation with a view to achieving the Union priorities for rural development, including the EIP for agricultural productivity and sustainability, towards the environment, including the specific needs of Natura 2000 areas, and towards climate change mitigation and adaptation is integrated into the programme; (vi) measures have been taken to ensure the availability of sufficient advisory capacity on the regulatory requirements and on actions related to innovation; (d) for each ex ante conditionality, established in accordance with Article 19, and part II of Annex XI to Regulation (EU) No 1303/2013 for the general ex ante conditionalities, and in accordance with Annex V to this Regulation, an assessment of which of the ex ante conditionalities are applicable to the programme and which of them are fulfilled at the date of submission of the Partnership Agreement and the programme. Where the applicable ex ante conditionalities are not fulfilled, the programme shall contain a description of the actions to be taken, the bodies responsible and a timetable for such actions in accordance with the summary submitted in the Partnership Agreement. (e) a description of the performance framework established for the purpose of Article 21 of Regulation (EU) No 1303/2013; (f) a description of each of the measures selected; (g) the evaluation plan referred to in Article 56 of Regulation (EU) No 1303/2013. The Member States shall provide sufficient resources to address the needs which have been identified and to ensure proper monitoring and evaluation; (h) a financing plan comprising: (i) a table setting out, in accordance with Article 58(4), the total EAFRD contribution planned for each year. When applicable this table shall indicate separately within the total EAFRD contribution the appropriations provided for the less developed regions and the funds transferred to the EAFRD in application of Article 7(2) of Regulation (EU) No 1307/2013. The planned annual EAFRD contribution shall be compatible with the Multi-annual Financial Framework; (ii) a table setting out, for each measure, for each type of operation with a specific EAFRD contribution rate and for technical assistance, the total Union contribution planned and the applicable EAFRD contribution rate. Where applicable, this table shall indicate separately the EAFRD contribution rate for less developed regions and for other regions; (i) an indicator plan, broken down into focus areas, comprising the targets referred to in point (i) of Article 8(1)(c) and the planned outputs and planned expenditure of each rural development measure selected in relation to a corresponding focus area; (j) where applicable, a table on additional national financing per measure in accordance with Article 82; (k) where applicable, the list of aid schemes falling under Article 81(1) to be used for the implementation of the programmes; (l) information on the complementarity with measures financed by the other common agricultural policy instruments, and by the European Structural and Investment Funds (\"ESI\"); (m) programme implementing arrangements including: (i) the designation by the Member State of all authorities referred to in Article 65(2) and, for information, a summary description of the management and control structure; (ii) a description of the monitoring and evaluation procedures, as well as the composition of the Monitoring Committee; (iii) the provisions to ensure that the programme is publicised, including through the national rural network referred to in Article 54; (iv) a description of the approach laying down principles with regard to the establishment of selection criteria for operations and local development strategies that takes into account relevant targets; in this context Member States may provide for priority to be given to SMEs linked to the agriculture and forestry sector. (v) in relation to local development, where applicable, a description of the mechanisms to ensure coherence between activities envisaged under the local development strategies, the \"Cooperation\" measure referred to in Article 35, and the \"Basic services and village renewal in rural areas\" measure referred to in Article 20 including urban-rural links; (n) the actions taken to involve the partners referred to in Article 5 of Regulation (EU) No 1303/2013 and a summary of the results of the consultation of the partners; (o) where applicable, the structure of the national rural network as referred to in Article 54(3), and provisions for its management, which would constitute the basis for its annual actions plans. 2. Where thematic sub-programmes are included in a rural development programme, each sub-programme shall include: (a) a specific analysis of the situation based on SWOT methodology and an identification of the needs that are to be addressed by the sub-programme; (b) specific targets at sub-programme level and a selection of measures, based on a thorough definition of the intervention logic of the sub-programme, including an assessment of the expected contribution of the measures chosen to achieve the targets; (c) a separate specific indicator plan, with planned outputs and planned expenditure for each rural development measure selected in relation to a corresponding focus area. 3. The Commission shall adopt implementing acts laying down rules for the presentation of the elements described in paragraphs 1 and 2 in rural development programmes and rules for the content of national frameworks referred to in Article 6(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. CHAPTER II Preparation, approval and modification of rural development programmes Article 9 Ex ante conditionalities In addition to the general ex ante conditionalities, referred to in part II of Annex XI to Regulation (EU) No 1303/2013, the ex ante conditionalities referred to in Annex V to this Regulation shall apply to the EAFRD programming, if relevant and applicable to the specific objectives pursued within the priorities of the programme. Article 10 Approval of rural development programmes 1. Member States shall submit to the Commission a proposal for each rural development programme, containing the information referred to in Article 8. 2. Each rural development programme shall be approved by the Commission by means of an implementing act Article 11 Amendment of rural development programmes Requests by Member States to amend programmes shall be approved in accordance with the following procedures: (a) The Commission shall decide, by means of implementing acts, on requests to amend programmes that concern one or more of the following: (i) a change in the programme strategy through a change of more than 50 % in the quantified target linked to a focus area; (ii) a change in the EAFRD contribution rate of one or more measures; (iii) a change of the entire Union contribution or its annual distribution at programme level; (b) The Commission shall approve, by means of implementing acts, requests to amend the programme in all other cases. These shall include, in particular: (i) the introduction or withdrawal of measures or types of operations; (ii) changes in the description of measures, including changes of eligibility conditions; (iii) a transfer of funds between measures implemented under different EAFRD contribution rates; However, for the purposes of points (b)(i) and (ii), and point (b)(iii)where the transfer of funds concerns less than 20 % of the allocation to a measure and less than 5 % of the total EAFRD contribution to the programme, the approval shall be deemed to be given, if the Commission has not taken a decision on the request after a period of 42 working days from the receipt of the request. That period shall not include the period starting on the day following the date on which the Commission has sent its observations to the Member State and ending on the day that the Member State responded to the observations. (c) The approval of the Commission shall not be required for corrections of a purely clerical or editorial nature that do not affect the implementation of the policy and the measures. Member States shall inform the Commission of such amendments. Article 12 Rules on procedures and timetables The Commission shall adopt implementing acts, laying down rules on procedures and timetables for: (a) the approval of rural development programmes and national frameworks; (b) the submission and approval of proposals for amendments to rural development programmes and proposals for amendments to national frameworks, including their entry into force and the frequency with which they are to be submitted during the programming period. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. TITLE III RURAL DEVELOPMENT SUPPORT CHAPTER I Measures Article 13 Measures Each rural development measure shall be programmed to contribute specifically to the achievement of one or more Union priorities for rural development. An indicative list of measures of particular relevance to the Union priorities is set out in Annex VI. Article 14 Knowledge transfer and information actions 1. Support under this measure shall cover vocational training and skills acquisition actions, demonstration activities and information actions. Vocational training and skills acquisition actions may include training courses, workshops and coaching. Support may also cover short-term farm and forest management exchanges as well as farm and forest visits. 2. Support under this measure shall be for the benefit of persons engaged in the agricultural, food and forestry sector, land managers and other economic actors which are SMEs operating in rural areas. The training or other knowledge transfer and information action provider shall be the beneficiary of the support. 3. Support under this measure shall not include courses of instruction or training, which form part of normal education programmes or systems at secondary or higher levels. Bodies providing knowledge transfer and information services shall have the appropriate capacities in the form of staff qualifications and regular training to carry out this task. 4. Eligible costs under this measure shall be the costs of organising and delivering the knowledge transfer or information action. In the case of demonstration projects, support may also cover relevant investment costs. Costs for travel, accommodation and per diem expenses of participants as well as the cost of the replacement of farmers shall also be eligible for support. All costs identified under this paragraph shall be paid to the beneficiary. 5. In order to ensure that farm and forest exchange schemes and visits are clearly demarcated in relation to similar actions under other Union schemes, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the duration and content of farm and forest exchange schemes and farm and forest visits. 6. The Commission shall adopt implementing acts laying down the rules on payment modalities for participants' costs, including through the use of vouchers or other similar forms. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. Article 15 Advisory services, farm management and farm relief services 1. Support under this measure shall be granted in order to: (a) help farmers, young farmers as defined in this Regulation, forest holders, other land managers and SMEs in rural areas benefit from the use of advisory services for the improvement of the economic and environmental performance as well as the climate friendliness and resilience of their holding, enterprise and/or investment; (b) promote the setting up of farm management, farm relief and farm advisory services, as well as forestry advisory services, including the Farm Advisory System referred to in Articles 12 to 14 of Regulation (EU) No 1306/2013; (c) promote the training of advisors. 2. The beneficiary of support provided in paragraph 1(a) and (c) shall be the provider of advice or training. Support under paragraph 1(b) shall be granted to the authority or body selected to set up the farm management, farm relief, farm advisory or forestry advisory service. 3. The authorities or bodies selected to provide advice shall have appropriate resources in the form of regularly trained and qualified staff and advisory experience and reliability with respect to the fields in which they advise. The beneficiaries under this measure shall be chosen through calls for tenders. The selection procedure shall be governed by public procurement law and shall be open to both public and private bodies. It shall be objective and shall exclude candidates with conflicts of interest. When providing advice, advisory services shall respect the non-disclosure obligations referred to in Article 13(2) of Regulation (EU) No 1306/2013. 4. Advice to the individual farmers, young farmers as defined in this Regulation and other land managers shall be linked to at least one Union priority for rural development and shall cover as a minimum one of the following elements: (a) obligations at farm level deriving from the statutory management requirements and/or standards for good agricultural and environmental conditions provided for in Chapter I of Title VI of Regulation (EU) No 1306/2013; (b) where applicable, the agricultural practices beneficial for the climate and the environment as laid down in Chapter 3 of Title III of Regulation (EU) No 1307/2013 and the maintenance of the agricultural area as referred to in point (c) of Article 4(1) of Regulation (EU) No 1307/2013; (c) measures at farm level provided for in rural development programmes aiming at farm modernisation, competitiveness building, sectoral integration, innovation and market orientation, as well as the promotion of entrepreneurship; (d) requirements as defined by Member States for implementing Article 11(3) of the Water Framework Directive; (e) requirements as defined by Member States, for implementing Article 55 of Regulation (EC) No 1107/2009, in particular compliance with the general principles of integrated pest management as referred to in Article 14 of Directive 2009/128/EC; or (f) where relevant, occupational safety standards or safety standards linked to the farm; (g) specific advice for farmers setting up for the first time. Advice may also cover other issues and in particular the information related to climate change mitigation and adaptation, biodiversity and the protection of water as laid down in Annex I to Regulation (EU) No 1307/2013 or issues linked to the economic and environmental performance of the agricultural holding, including competitiveness aspects. This may include advice for the development of short supply chains, organic farming and health aspects of animal husbandry. 5. Advice to forest holders shall cover, as a minimum, the relevant obligations under Directives 92/43/EEC, 2009/147/EC and the Water Framework Directive. It may also cover issues linked to the economic and environmental performance of the forest holding. 6. Advice to SMEs may cover issues linked to the economic and environmental performance of the enterprise. 7. Where duly justified and appropriate, advice may be provided partly in a group, while taking into account the situations of the individual user of advisory services. 8. Support under points (a) and (c) of paragraph 1 shall be limited to the maximum amounts laid down in Annex II. Support under point (b) of paragraph 1 shall be degressive over a maximum period of five years from setting up. Article 16 Quality schemes for agricultural products, and foodstuffs 1. Support under this measure shall cover new participation by farmers and groups of farmers in: (a) quality schemes established under the following Regulations and provisions: (i) Regulation (EU) 1151/2012 of the European Parliament and of the Council (18); (ii) Council Regulation (EC) No 834/2007 (19); (iii) Regulation (EC) No 110/2008 of the European Parliament and of the Council (20); (iv) Council Regulation (EEC) No 1601/91 (21); (v) Part II, Title II, Chapter I, Section 2 of Council Regulation (EU) No 1308/2013 as concerns wine. (b) quality schemes, including farm certification schemes, for agricultural products, cotton or foodstuffs, recognised by the Member States as complying with the following criteria: (i) the specificity of the final product under such schemes is derived from clear obligations to guarantee any of the following: \u2014 specific product characteristics, \u2014 specific farming or production methods, or \u2014 a quality of the final product that goes significantly beyond the commercial commodity standards as regards public, animal or plant health, animal welfare or environmental protection; (ii) the scheme is open to all producers; (iii) the scheme involves binding product specifications and compliance with those specifications is verified by public authorities or by an independent inspection body; (iv) the scheme is transparent and assures complete traceability of products; or (c) voluntary agricultural product certification schemes recognised by the Member States as meeting the Union best practice guidelines for the operation of voluntary certification schemes relating to agricultural products and foodstuffs. 2. Support under this measure may also cover costs arising from information and promotion activities implemented by groups of producers in the internal market, concerning products covered by a quality scheme receiving support in accordance with paragraph 1. 3. Support under paragraph 1 shall be granted as an annual incentive payment, the level of which shall be determined according to the level of the fixed costs arising from participation in supported schemes, for a maximum duration of five years. For the purposes of this paragraph, \"fixed costs\" means the costs incurred for entering a supported quality scheme and the annual contribution for participating in that scheme, including, where necessary, expenditure on checks required to verify compliance with the specifications of the scheme. For the purposes of this Article, \"farmer\" means active farmer within the meaning of Article 9 of Regulation (EU) No 1307/2013. 4. Support shall be limited to the maximum support rate and amount laid down in Annex II. 5. In order to take into account new Union law that may affect support under this measure and in order to ensure consistency with other Union instruments on promotion of agricultural measures and prevent distortion of competition, the Commission shall be empowered to adopt delegated acts, in accordance with Article 83 concerning, the specific Union schemes to be covered by point (a) of paragraph 1 and the characteristics of groups of producers and the types of actions that may receive support under paragraph 2, the setting of conditions to prevent discrimination against certain products; and the setting of conditions on the basis of which commercial brands are to be excluded from support. Article 17 Investments in physical assets 1. Support under this measure shall cover tangible and/or intangible investments which: (a) improve the overall performance and sustainability of the agricultural holding; (b) concern the processing, marketing and/or development of agricultural products covered by Annex I to the Treaty or cotton, except fishery products; the output of the production process may be a product not covered by that Annex; (c) concern infrastructure related to the development, modernisation or adaptation of agriculture and forestry, including access to farm and forest land, land consolidation and improvement, and the supply and saving of energy and water; or (d) are non -productive investments linked to the achievement of agri- environment -climate objectives as pursued under this regulation, including biodiversity conservation status of species and habitat as well as enhancing the public amenity value of a Natura 2000 area or other high nature value systems to be defined in the programme. 2. Support under point (a) of paragraph 1 shall be granted to farmers or groups of farmers. In the case of investments to support farm restructuring, Member States shall target the support to farms in accordance with the SWOT analysis carried out in relation to the Union priority for rural development \"enhancing farm viability and competitiveness of all types of agriculture in all regions and promoting innovative farm technologies and sustainable management of forests\". 3. Support under points (a) and (b) of paragraph 1 shall be limited to the maximum support rates laid down in Annex II. Those maximum rates may be increased for young farmers, for collective investments, including those linked to a merger of Producer Organisations, and for integrated projects involving support under more than one measure, for investments in areas facing natural and other specific constraints as referred to in Article 32, for investments linked to operations under Articles 28 and 29 and for operations supported in the framework of the EIP for agricultural productivity and sustainability in accordance with the support rates laid down in Annex II. However, the maximum combined support rate may not exceed 90 %. 4. Support under points (c) and (d) of paragraph 1 shall be subject to the support rates laid down in Annex II. 5. Support may be granted to young farmers setting up for the first time in an agricultural holding as head of the holding in respect of investments to comply with Union standards applying to agricultural production, including occupational safety. Such support may be provided for a maximum of 24 months from the date of setting up. 6. Where Union law imposes new requirements on farmers support may be granted for investments to comply with those requirements for a maximum of 12 months from the date on which they become mandatory for the agricultural holding. Article 18 Restoring agricultural production potential damaged by natural disasters and catastrophic events and introduction of appropriate prevention actions 1. Support under this measure shall cover: (a) investments in preventive actions aimed at reducing the consequences of probable natural disasters, adverse climatic events and catastrophic events; (b) investments for the restoration of agricultural land and production potential damaged by natural disasters, adverse climatic events and catastrophic events. 2. Support shall be granted to farmers or groups of farmers. Support may also be granted to public entities where a link between the investment undertaken by such entities and agricultural production potential is established. 3. Support under point (b) of paragraph 1 shall be subject to the formal recognition by the competent public authorities of Member States that a natural disaster has occurred and that this disaster or measures adopted in accordance with Council Directive 2000/29/EC (22) to eradicate or contain a plant disease or pest has caused the destruction of at least 30 % of the relevant agricultural potential. 4. No support under this measure shall be granted for loss of income resulting from the natural disaster or catastrophic event. Member States shall ensure that overcompensation as a result of the combination of this measure and other national or Union support instruments or private insurance schemes is avoided. 5. Support under point (a) of paragraph 1 shall be limited to the maximum support rates laid down in Annex II. Article 19 Farm and business development 1. Support under this measure shall cover: (a) business start-up aid for: (i) young farmers; (ii) non-agricultural activities in rural areas; (iii) the development of small farms; (b) investments in creation and development of non-agricultural activities; (c) annual payments or one-off payments for farmers eligible for the small farmers scheme established by Title V of Regulation (EU) No 1307/2013 (\"the small farmers scheme\") who permanently transfer their holding to another farmer; 2. Support under point (a)(i) of paragraph 1 shall be granted to young farmers. Support under point (a)(ii) of paragraph 1 shall be granted to farmers or members of a farm household who diversify into non-agricultural activities and to micro- and small- enterprises and natural persons in rural areas. Support under point (a)(iii) of paragraph 1 shall be granted to small farms as defined by Member States. Support under point (b) of paragraph 1 shall be granted to micro- and small enterprises and natural persons in rural areas, as well as to farmers or members of a farm household. Support under point (c) of paragraph 1 shall be granted to farmers eligible to participate in the small farmers scheme who, at the time of submitting their application for support, have been so eligible for at least one year and who undertake to permanently transfer their entire holding and the corresponding payment entitlements to another farmer. Support shall be paid from the date of the transfer until 31 December 2020 or calculated in respect of that period and paid in the form of a one-off payment. 3. Any natural or legal person or a group of natural or legal persons, whatever legal status is granted to the group and its members by national law, may be considered to be a member of a farm household, with the exception of farm workers. Where a legal person or a group of legal persons is considered to be a member of the farm household, that member must exercise an agricultural activity on the farm at the time of the support application. 4. Support under point (a) of paragraph 1 shall be conditional on the submission of a business plan. Implementation of the business plan must start within nine months from the date of the decision granting the aid. For young farmers receiving support under point (a)(i) of paragraph 1, the business plan shall provide that the young farmer complies with Article 9 of Regulation (EU) No 1307/2013, regarding active farmers within 18 months from the date of setting up. Member States shall define upper and lower thresholds for allowing agricultural holdings access to support under points (a)(i) and (a)(iii) of paragraph 1. The lower threshold for support under point (a)(i) of paragraph 1 shall be higher than the upper threshold for support under point (a)(iii) of paragraph 1. Support shall be limited to holdings coming under the definition of micro and small enterprises. 5. Support under point (a) of paragraph 1 shall be paid in at least two instalments over a period of maximum five years. Instalments may be degressive. The payment of the last instalment, under points (a)(i) and (a)(ii) of paragraph 1 shall be conditional upon the correct implementation of the business plan. 6. The maximum amount of support under point (a) of paragraph 1 is laid down in Annex II. Member States shall define the amount of support under points (a)(i) and (a)(ii) of paragraph 1 also taking into account the socio-economic situation of the programme area. 7. Support under point (c) of paragraph 1 shall be equal to 120 % of the annual payment that the beneficiary is eligible to receive under the small farmers scheme. 8. In order to ensure the efficient and effective use of EAFRD resources, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down the minimum content of business plans and the criteria to be used by Member states for setting the thresholds referred to in paragraph 4 of this Article. Article 20 Basic services and village renewal in rural areas 1. Support under this measure shall cover, in particular: (a) the drawing up and updating of plans for the development of municipalities and villages in rural areas and their basic services and of protection and management plans relating to Natura 2000 sites and other areas of high nature value; (b) investments in the creation, improvement or expansion of all types of small scale infrastructure, including investments in renewable energy and energy saving; (c) broadband infrastructure, including its creation, improvement and expansion, passive broadband infrastructure and provision of access to broadband and public e-government solutions; (d) investments in the setting up, improvement or expansion of local basic services for the rural population, including leisure and culture, and the related infrastructure; (e) investments for public use in recreational infrastructure, tourist information and small scale tourism infrastructure; (f) studies and investments associated with the maintenance, restoration and upgrading of the cultural and natural heritage of villages, rural landscapes and high nature value sites, including related socio-economic aspects, as well as environmental awareness actions; (g) investments targeting the relocation of activities and conversion of buildings or other facilities located within or close to rural settlements, with a view to improving the quality of life or increasing the environmental performance of the settlement. 2. Support under this measure shall only concern small-scale infrastructure, as defined by each Member State in the programme. However, rural development programmes may provide for specific derogations from this rule for investments in broadband and renewable energy. In this case, clear criteria ensuring complementarity with support under other Union instruments shall be provided. 3. Investments under paragraph 1 shall be eligible for support where the relevant operations are implemented in accordance with plans for the development of municipalities and villages in rural areas and their basic services, where such plans exist and shall be consistent with any relevant local development strategy. Article 21 Investments in forest area development and improvement of the viability of forests 1. Support under this measure shall concern: (a) afforestation and creation of woodland; (b) establishment of agroforestry systems; (c) prevention and restoration of damage to forests from forest fires, natural disasters and catastrophic events, including pest and disease outbreaks, and climate related threats; (d) investments improving the resilience and environmental value as well as the mitigation potential of forest ecosystems; (e) investments in forestry technologies and in the processing, the mobilising and the marketing of forest products. 2. Limitations on ownership of forests provided for in Articles 22 to 26 shall not apply to the tropical or subtropical forests and to the wooded areas of the territories of the Azores, Madeira, the Canary islands, the smaller Aegean islands within the meaning of Council Regulation (EEC) No 2019/93 (23) and the French overseas departments. For holdings above a certain size, to be determined by the Member States in the programme, support shall be conditional on the presentation of the relevant information from a forest management plan or equivalent instrument in line with sustainable forest management as defined by the Ministerial Conference on the Protection of Forests in Europe of 1993. Article 22 Afforestation and creation of woodland 1. Support under point (a) of Article 21(1) shall be granted to public and private land-holders-and their associations and shall cover the costs of establishment and an annual premium per hectare to cover the costs of agricultural income foregone and maintenance, including early and late cleanings, for a maximum period of twelve years. In the case of state-owned land, support may only be granted if the body managing such land is a private body or a municipality. Support for afforestation of land owned by public authorities or for fast growing trees shall cover only the costs of establishment. 2. Both agricultural and non-agricultural land shall be eligible. Species planted shall be adapted to the environmental and climatic conditions of the area and shall comply with minimum environmental requirements. No support shall be granted for the planting of trees for short rotation coppicing, Christmas trees or fast growing trees for energy production. In areas where afforestation is made difficult by severe pedo-climatic conditions support may be provided for planting other perennial woody species such as shrubs or bushes suitable to the local conditions. 3. In order to ensure that afforestation of agricultural land is in line with the aims of environmental policy, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the definition of the minimum environmental requirements referred to in paragraph 2 of this Article. Article 23 Establishment of agroforestry systems 1. Support under point (b) of Article 21(1) shall be granted to private land-holders, municipalities and their associations and shall cover the costs of establishment and an annual premium per hectare to cover the costs of maintenance for a maximum period of five years. 2. For the purposes of this Article, agroforestry systems means land use systems in which trees are grown in combination with agriculture on the same land. The minimum and maximum number of trees per hectare shall be determined by the Member States taking account of local pedo-climatic and environmental conditions, forestry species and the need to ensure sustainable agricultural use of the land. 3. Support shall be limited to the maximum support rate laid down in Annex II. Article 24 Prevention and restoration of damage to forests from forest fires and natural disasters and catastrophic events 1. Support under point (c) Article 21(1) shall be granted to private and public forest- holders and other private law and public bodies and their associations and shall cover the costs for: (a) the establishment of protective infrastructure. In the case of firebreaks, support may also cover aid contributing to maintenance costs. No support shall be granted to agricultural related activities in areas covered by agri-environment commitments; (b) local, small scale prevention activities against fire or other natural hazards; including the use of grazing animals; (c) establishing and improving forest fire, pest and diseases monitoring facilities and communication equipment; and (d) restoring forest potential damaged from fires and other natural disasters including pests, diseases as well as catastrophic events and climate change related events. 2. In the case of preventive actions concerning pests and diseases, the risk of a relevant disaster occurrence must be supported by scientific evidence and acknowledged by scientific public organisations. Where relevant, the list of species of organisms harmful to plants which may cause a disaster must be provided in the programme. Eligible operations shall be consistent with the forest protection plan established by the Member States. For holdings above a certain size, to be determined by the Member States in the programme, support shall be conditional on the presentation of the relevant information from a forest management plan or equivalent instrument in line with sustainable forest management as defined by the Ministerial Conference on the Protection of Forests in Europe of 1993 detailing the preventive objectives. Forest areas classified as medium to high forest fire risk according to the forest protection plan established by the Member States shall be eligible for support relating to forest fire prevention. 3. Support under point (d) of paragraph 1 shall be subject to the formal recognition by the competent public authorities of Member States that a natural disaster has occurred and that that disaster, or measures adopted in accordance with Directive 2000/29/EC to eradicate or contain a plant disease or pest has caused the destruction of at least 20 % of the relevant forest potential. 4. No support under this measure shall be granted for loss of income resulting from the natural disaster. Member States shall ensure that overcompensation as a result of the combination of this measure and other national or Union support instruments or private insurance schemes is avoided. Article 25 Investments improving the resilience and environmental value of forest ecosystems 1. Support under point (d) of Article 21(1) shall be granted to natural persons, private and public forest-holders, and other private law and public bodies and their associations. 2. Investments shall be aimed at the achievement of commitments for environmental aims, for the provision of ecosystem services and/or for the enhancement of the public amenity value of forest and wooded land in the area concerned or the improvement of the climate change mitigation potential of ecosystems, without excluding economic benefits in the long term. Article 26 Investments in forestry technologies and in processing, in mobilising and in the marketing of forest products 1. Support under point (e) of Article 21(1) shall be granted to private forest- holders, municipalities and their associations and to SMEs for investments enhancing forestry potential or relating to processing, mobilising and marketing adding value to forest products. In the territories of the Azores, Madeira, the Canary islands, the smaller Aegean islands within the meaning of Regulation (EEC) No 2019/93 and the French overseas departments support may also be granted to enterprises that are not SMEs. 2. Investments related to the improvement of the economic value of forests shall be justified in relation to expected improvements to forests on one or more holdings and may include investments for soil-friendly and resource -friendly harvesting machinery and practices. 3. Investments related to the use of wood as a raw material or energy source shall be limited to all working operations prior to industrial processing. 4. Support shall be limited to the maximum support rates laid down in Annex II. Article 27 Setting -up of producer groups and organisations 1. Support under this measure shall be granted in order to facilitate the setting up of producer groups and organisations in the agriculture and forestry sectors for the purpose of: (a) adapting the production and output of producers who are members of such groups or organisations to market requirements; (b) jointly placing goods on the market, including preparation for sale, centralisation of sales and supply to bulk buyers; (c) establishing common rules on production information, with particular regard to harvesting and availability; and (d) other activities that may be carried out by producer groups and organisations, such as the development of business and marketing skills and the organisation and facilitation of the innovation processes. 2. Support shall be granted to producer groups and organisations which are officially recognised by a Member State's competent authority on the basis of a business plan. It shall be limited to producer groups and organisations that are SMEs. Member States shall verify that the objectives of the business plan have been reached within five years after recognition of the producer group or organisation. 3. The support shall be paid on the basis of a business plan as a flat rate aid in annual instalments for no more than five years following the date on which the producer group or organisation was recognised, and shall be degressive. It shall be calculated on the basis of the annual marketed production of the group or organisation. Member States shall pay the last instalment only after having verified the correct implementation of the business plan. In the first year Member States may pay support to the producer group or organisation calculated on the basis of the average annual value of the marketed production of its members over the three years before they entered the group or organisation. In the case of producer groups and organisations in the forestry sector, support shall be calculated on the basis of the average marketed production of the members of the group or organisation over the last five years before the recognition, excluding the highest and the lowest value. 4. Support shall be limited to the maximum rates and amounts laid down in Annex II. 5. Member States may continue support for setting up of producer groups even after they have been recognised as producer organisations under the conditions of Regulation (EU) No 1308/2013 (24). Article 28 Agri-environment-climate 1. Member States shall make support under this measure available throughout their territories, in accordance with their national, regional or local specific needs and priorities. This measure shall aim to preserve and promote the necessary changes to agricultural practices that make a positive contribution to the environment and climate. Its inclusion in rural development programmes shall be compulsory at national and/or regional level. 2. Agri-environment-climate payments shall be granted to farmers, groups of farmers or groups of farmers and other land-managers who undertake, on a voluntary basis, to carry out operations consisting of one or more agri-environment-climate commitments on agricultural land to be defined by Member States, including but not limited to the agricultural area defined under Article 2 of this Regulation. Where duly justified to achieve environmental objectives, agri-environment-climate payments may be granted to other land-managers or groups of other land-managers. 3. Agri-environment-climate payments cover only those commitments going beyond the relevant mandatory standards established pursuant to Chapter I of Title VI of Regulation (EU) No 1306/2013, the relevant criteria and minimum activities as established pursuant to points (c)(ii) and (c)(iii) of Article 4(1) of Regulation (EU) No 1307/2013, and relevant minimum requirements for fertiliser and plant protection products use as well as other relevant mandatory requirements established by national law. All such mandatory requirements shall be identified in the programme. 4. Member States shall endeavour to ensure that persons undertaking to carry out operations under this measure are provided with the knowledge and information required to implement such operations. They may do so through, inter alia, commitment-related expert advice and/or by making support under this measure conditional on obtaining relevant training. 5. Commitments under this measure shall be undertaken for a period of five to seven years. However, where necessary in order to achieve or maintain the environmental benefits sought, Member States may determine a longer period in their rural development programmes for particular types of commitments, including by means of providing for their annual extension after the termination of the initial period. For new commitments directly following the commitment performed in the initial period, Member States may determine a shorter period in their rural development programmes. 6. Payments shall be granted annually and shall compensate beneficiaries for all or part of the additional costs and income foregone resulting from the commitments made. Where necessary, they may also cover transaction costs up to a value of 20 % of the premium paid for the agri-environment-climate commitments. Where commitments are undertaken by groups of farmers or groups of farmers and other land managers, the maximum level shall be 30 %. When calculating the payments referred to in the first sub-paragraph, Member States shall deduct the amount necessary in order to exclude double funding of the practices referred to in Article 43 of Regulation (EU) No 1306/2013. In duly justified cases for operations concerning environmental conservation, support may be granted at a flat-rate or as a one-off payment per unit for commitments to renounce commercial use of areas, calculated on the basis of additional costs incurred and income foregone. 7. Where required in order to ensure the efficient application of the measure, Member States may use the procedure referred to in Article 49(3) for the selection of beneficiaries. 8. Support shall be limited to the maximum amounts laid down in Annex II. No support under this measure may be granted for commitments that are covered under the organic farming measure. 9. Support may be provided for the conservation and for the sustainable use and development of genetic resources in agriculture for operations not covered by the provisions under paragraphs 1 to 8. Such commitments may be carried out by beneficiaries other than those referred to in paragraph 2. 10. In order to ensure that agri-environment-climate commitments are defined in accordance with the Union priorities for rural development, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the following: (a) the conditions applicable to commitments to extensify livestock farming; (b) the conditions applicable to commitments to rear local breeds that are in danger of being lost to farming or to preserve plant genetic resources that are under threat of genetic erosion, and (c) the definition of eligible operations under paragraph 9. 11. In order to ensure that double funding, as referred to in the second subparagraph of paragraph 6 is excluded, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down the calculation method to be used, including in the case of equivalent measures under Article 43 of Regulation (EU) No 1306/2013. Article 29 Organic farming 1. Support under this measure shall be granted, per hectare of agricultural area, to farmers or groups of farmers who undertake, on a voluntary basis, to convert to or maintain organic farming practices and methods as defined in Regulation (EC) No 834/2007 and who are active farmers within the meaning of Article 9 of Regulation (EU) No 1307/2013. 2. Support shall only be granted for commitments going beyond the relevant mandatory standards established pursuant to Chapter I of Title VI of Regulation (EU) No 1306/2013, the relevant criteria and minimum activities as established pursuant to points (c)(ii) and (c)(iii) of Article 4(1) of Regulation (EU) No DP/2013, relevant minimum requirements for fertiliser and plant protection products use as well as other relevant mandatory requirements established by national law. All such requirements shall be identified in the programme. 3. Commitments under this measure shall be made for a period of five to seven years. Where support is granted for conversion to organic farming Member States may determine a shorter initial period corresponding to the period of conversion. Where support is granted for the maintenance of organic farming, Member States may provide in their rural development programmes for annual extension after the termination of the initial period. For new commitments concerning maintenance that directly follow the commitment performed in the initial period, Member States may determine a shorter period in their rural development programmes. 4. Payments shall be granted annually and shall compensate beneficiaries for all or part of the additional costs and income foregone resulting from the commitments made. Where necessary they may also cover transaction costs to a value of up to 20 % of the premium paid for the commitments. Where commitments are undertaken by groups of farmers, the maximum level shall be 30 %. When calculating the payments referred to in the first sub-paragraph, Member States shall deduct the amount necessary in order to exclude double funding of the practices referred to in Article 43 of Regulation (EU) No 1307/2013. 5. Support shall be limited to the maximum amounts laid down in Annex II. 6. In order to ensure that double funding, as referred to in the second subparagraph of paragraph 4 is excluded, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down the calculation method to be used. Article 30 Natura 2000 and Water Framework Directive payments 1. Support under this measure shall be granted annually per hectare of agricultural area or per hectare of forest in order to compensate beneficiaries for additional costs and income foregone resulting from disadvantages in the areas concerned, related to the implementation of Directives 92/43/EEC and Directive 2009/147/EC and the Water Framework Directive. When calculating support under this measure, Member States shall deduct the amount necessary in order to exclude double funding of the practices referred to in Article 43 of Regulation (EU) No 1307/2013. 2. Support shall be granted to farmers and to private forest holders and associations of private forest holders. In duly justified cases it may also be granted to other land managers. 3. Support to farmers, linked to Directives 92/43/EEC and 2009/147/EC shall only be granted in relation to disadvantages resulting from requirements that go beyond the good agricultural and environmental condition provided for in Article 94 and Annex II of Council Regulation (EU) No 1306/2013 and the relevant criteria and minimum activities established pursuant to points (c)(ii) and (c)(iii) of Article 4(1) of point (c) of Article 4(1)of Regulation (EU) No 1307/2013. 4. Support to farmers, linked to the Water Framework Directive shall only be granted in relation to specific requirements that: (a) were introduced by the Water Framework Directive, are in accordance with the programmes of measures of the river basin management plans for the purpose of achieving the environmental objectives of that Directive and go beyond the measures required to implement other Union law for the protection of water; (b) go beyond the statutory management requirements and the good agricultural and environmental condition provided for in Chapter I of Title VI of Regulation (EU) No 1306/2013 and the relevant criteria and minimum activities as established pursuant to points (c)(ii) and (c)(iii) of Article 4(1) of Regulation (EU) No 1307/2013; (c) go beyond the level of protection of the Union law existing at the time the Water Framework Directive was adopted as laid down in Article 4(9) of that Directive; and (d) impose major changes in type of land use, and/or major restrictions in farming practice resulting in a significant loss of income. 5. The requirements referred to in paragraphs 3 and 4 shall be identified in the programme. 6. The following areas shall be eligible for payments: (a) Natura 2000 agricultural and forest areas designated pursuant to Directives 92/43/EEC and 2009/147/EC; (b) other delimited nature protection areas with environmental restrictions applicable to farming or forests which contribute to the implementation of Article 10 of Directive 92/43/EEC, provided that, per rural development programme, those areas do not exceed 5 % of the designated Natura 2000 areas covered by its territorial scope; (c) agricultural areas included in river basin management plans according to the Water Framework Directive. 7. Support shall be limited to the maximum amounts laid down in Annex II. 8. In order to ensure that double funding, as referred to in the second subparagraph of paragraph 1 is excluded, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down the calculation method to be used. Article 31 Payments to areas facing natural or other specific constraints 1. Payments to farmers in mountain areas and other areas facing natural or other specific constraints shall be granted annually per hectare of agricultural area in order to compensate farmers for all or part of the additional costs and income foregone related to the constraints for agricultural production in the area concerned. Additional costs and income foregone shall be calculated in comparison to areas which are not affected by natural or other specific constraints, taking into account payments pursuant to Chapter 3 of Title III of Regulation (EU) No 1307/2013. When calculating additional costs and income foregone, Member States may, where duly justified, differentiate the level of payment taking into account: \u2014 the severity of the identified permanent constraint affecting farming activities; \u2014 the farming system. 2. Payments shall be granted to farmers who undertake to pursue their farming activity in the areas designated pursuant to Article 32 and are active farmers within the meaning of Article 9 of Regulation (EU) No 1307/2013. 3. Payments shall be fixed between the minimum and maximum amount laid down in Annex II. These payments may be increased in duly substantiated cases taking into account specific circumstances to be justified in the rural development programmes. 4. Member States shall provide for degressivity of payments above a threshold level of area per holding, to be defined in the programme, except if the grant covers only the minimum payment per hectare per year as laid down in Annex II. In the case of a legal person, or a group of natural or legal persons, Member States may apply the degressivity of payments at the level of the members of these legal persons or groups on condition that: (a) national law provides for the individual members to assume rights and obligations comparable to those of individual farmers who have the status of head of holding, in particular as regards their economic, social and tax status; and (b) those individual members have contributed to strengthening the agricultural structures of the legal persons or groups concerned. 5. In addition to the payments provided for in paragraph 2, Member States may grant payments under this measure between 2014 and 2020 to beneficiaries in areas which were eligible under Article 36(a)(ii) of Regulation (EC) No 1698/2005 during the 2007-2013 programming period. For beneficiaries in areas that are no longer eligible following the new delimitation referred to in Article 32(3), those payments shall be degressive over a maximum period of four years. That period shall start on the date that the delimitation in accordance with Article 32(3) is completed and at the latest in 2018. Those payments shall start at no more than 80 % of the average payment fixed in the programme for the programming period 2007-2013 in accordance with Article 36(a)(ii) of Regulation (EC) No 1698/2005, and shall end in 2020 at the latest at no more than 20 %. When the application of degressivity results in the level of the payment reaching EUR 25, the Member State can continue payments at this level until the phasing out period is completed. Following completion of the delimitation, beneficiaries in the areas that remain eligible shall receive full payment under this measure. Article 32 Designation of areas facing natural and other specific constraints 1. Member States shall, on the basis of paragraphs 2, 3 and 4, designate areas eligible for payments provided for in Article 31 under the following categories: (a) mountain areas; (b) areas, other than mountain areas, facing significant natural constraints; and (c) other areas affected by specific constraints. 2. In order to be eligible for payments under Article 31, mountain areas shall be characterized by a considerable limitation of the possibilities for using the land and by an appreciable increase in production costs due to: (a) the existence, because of altitude, of very difficult climatic conditions, the effect of which is to substantially shorten the growing season; (b) at a lower altitude, the presence over the greater part of the area in question of slopes too steep for the use of machinery or requiring the use of very expensive special equipment, or a combination of these two factors, where the constraints resulting from each taken separately are less acute but the combination of the two gives rise to an equivalent constraints. Areas north of the 62nd parallel and certain adjacent areas shall be considered to be mountain areas. 3. In order to be eligible for payments under Article 31, areas, other than mountain areas, shall be considered to be facing significant natural constraints if, at least 60 % of the agricultural area meets at least one of the criteria listed in Annex III at the threshold value indicated. Compliance with those conditions shall be ensured at the level of local administrative units (\"LAU 2\" level) or at the level of a clearly delineated local unit which covers a single clear contiguous geographical area with a definable economic and administrative identity. When delimiting the areas concerned by this paragraph, Member States shall carry out a fine-tuning exercise, based on objective criteria, with the purpose of excluding areas in which significant natural constraints, referred to in the first subparagraph have been documented but have been overcome by investments or by, economic activity, or by evidence of normal land productivity, or in which production methods or farming systems have offset the income loss or added costs referred to in Article 31(1). 4. Areas other than those referred to in paragraphs 2 and 3 shall be eligible for payments under Article 31 if they are affected by specific constraints and if it is necessary for land management to be continued in order to conserve or improve the environment, to maintain the countryside, to preserve the tourist potential of the area or to protect the coastline. Areas affected by specific constraints shall comprise farming areas within which the natural production conditions are similar and the total extent of which does not exceed 10 % of the area of the Member State concerned. In addition, areas may also be eligible for payments under this paragraph, where: \u2014 at least 60 % of the agricultural area meets at least two of the criteria listed in Annex III each within a margin of not more than 20 % of the threshold value indicated, or \u2014 at least 60 % of the agricultural area is composed of areas meeting at least one of the criteria listed in Annex III at the threshold value indicated, and areas meeting at least two of the criteria listed in Annex III each within a margin of not more than 20 % of the threshold value indicated. Compliance with those conditions shall be ensured at LAU2 level or at the level of a clearly delineated local unit which covers a single clear contiguous geographical area with a definable economic and administrative identity. When delimiting areas concerned by this subparagraph, Member States shall undertake a fine-tuning exercise as described in Article 32(3). Areas considered eligible pursuant to this subparagraph, shall be taken into account for calculating the 10 % limit referred to in the second subparagraph. By way of derogation, the first sub-paragraph shall not apply to Member States the entire territory of which was considered as an area facing specific handicaps under Regulations (EC) No 1698/2005 and (EC) No 1257/1999. 5. Member States shall attach to their rural development programmes: (a) the existing or amended delimitation pursuant to paragraphs 2 and 4; (b) the new delimitation of the areas referred to in paragraph 3. Article 33 Animal welfare 1. Animal welfare payments under this measure shall be granted to farmers who undertake, on a voluntary basis, to carry out operations consisting of one or more animal welfare commitments and who are active farmers within the meaning of Article 9 of Regulation (EU) No 1307/2013. 2. Animal welfare payments cover only those commitments going beyond the relevant mandatory standards established pursuant to Chapter I of Title VI of Regulation (EU) No 1306/2013 and other relevant mandatory requirements. These relevant requirements shall be identified in the programme. Those commitments shall be undertaken for a renewable period of one to seven years. 3. The payments shall be granted annually and shall compensate farmers for all or part of the additional costs and income foregone resulting from the commitment made. Where necessary, they may also cover transaction costs to the value of up to 20 % of the premium paid for the animal welfare commitments. Support shall be limited to the maximum amount laid down in Annex II. 4. In order to ensure that animal welfare commitments are in accordance with the overall Union policy in this field, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the definition of the areas in which animal welfare commitments are to provide upgraded standards of production methods. Article 34 Forest-environmental and climate services and forest conservation 1. Support under this measure shall be granted per hectare of forest to public and private forest-holders and other private law and public bodies and their associations who undertake, on a voluntary basis, to carry out operations consisting of one or more forest-environment and climate commitments. In the case of state owned forests, support may only be granted if the body managing such a forest is a private body or a municipality. For forest holdings above a certain threshold to be determined by Member States in their rural development programmes, support under paragraph 1 shall be conditional on the presentation of the relevant information from a forest management plan or equivalent instrument in line with sustainable forest management as defined by the Ministerial Conference on the Protection of Forests in Europe of 1993. 2. Payments shall cover only those commitments going beyond the relevant mandatory requirements established by the national forestry act or other relevant national law. All such requirements shall be identified in the programme. Commitments shall be undertaken for a period of between five and seven years. However, where necessary and duly justified, Member States may determine a longer period in their rural development programmes for particular types of commitments. 3. Payments shall compensate beneficiaries for all or part of the additional costs and income foregone resulting from the commitments made. Where it is necessary they may also cover transaction costs to a value of up to 20 % of the premium paid for the forest-environment commitments. Support shall be limited to the maximum amount laid down in Annex II. In duly justified cases for operations concerning environmental conservation, support may be granted as a flat-rate or one-off payment per unit for commitments to renounce commercial use of trees and forests, calculated on basis of additional costs incurred and income foregone. 4. Support may be provided to public and private entities for the conservation and promotion of forest genetic resources for operations not covered under paragraphs 1, 2 and 3. 5. In order to ensure the efficient use of EAFRD budgetary resources, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the types of operations eligible for support under paragraph 4 of this Article. Article 35 Co-operation 1. Support under this measure shall be granted in order to promote forms of co-operation involving at least two entities and in particular: (a) co-operation approaches among different actors in the Union agriculture sector, forestry sector and food chain and other actors that contribute to achieving the objectives and priorities of rural development policy, including producer groups, cooperatives and inter-branch organisations; (b) the creation of clusters and networks; (c) the establishment and operation of operational groups of the EIP for agricultural productivity and sustainability as referred to in Article 56. 2. Co-operation under paragraph 1 shall relate, in particular, to the following: (a) pilot projects; (b) the development of new products, practices, processes and technologies in the agriculture, food and forestry sectors; (c) co-operation among small operators in organising joint work processes and sharing facilities and resources and for the development and/or marketing of tourism services relating to rural tourism; (d) horizontal and vertical co-operation among supply chain actors for the establishment and the development of short supply chains and local markets; (e) promotion activities in a local context relating to the development of short supply chains and local markets; (f) joint action undertaken with a view to mitigating or adapting to climate change; (g) joint approaches to environmental projects and ongoing environmental practices, including efficient water management, the use of renewable energy and the preservation of agricultural landscapes; (h) horizontal and vertical co-operation among supply chain actors in the sustainable provision of biomass for use in food and energy production and industrial processes; (i) implementation, in particular by groups of public and private partners other than those defined in point (b) of Article 32(2) of Regulation (EU) No 1303/2013, of local development strategies other than those defined in Article 2(19) of Regulation (EU) 1303/2013 addressing one or more of the Union priorities for rural development; (j) drawing up of forest management plans or equivalent instruments; (k) diversification of farming activities into activities concerning health care, social integration, community-supported agriculture and education about the environment and food. 3. Support under point (b) of paragraph 1 shall be granted only to newly formed clusters and networks and those commencing an activity that is new to them. Support for operations under points (a) and (b) of paragraph 2 may be granted also to individual actors where this possibility is provided for in the rural development programme. 4. The results of pilot projects under point (a) of paragraph 2 and operations under point (b) of paragraph 2 carried out by individual actors as provided for in paragraph 3 shall be disseminated. 5. The following costs, linked to the forms of co-operation referred to in paragraph 1 shall be eligible for support under this measure: (a) the cost of studies of the area concerned, of feasibility studies, and of drawing up a business plan or a forest management plan or equivalent or a local development strategy other than the one referred to in Article 33 of Regulation (EU) No 1303/2013; (b) the cost of animation of the area concerned in order to make feasible a collective territorial project or a project to be carried out by an operational group of the EIP for Agricultural Productivity and Sustainability as referred to in Article 56. In the case of clusters, animation may also concern the organisation of training, networking between members and the recruitment of new members; (c) the running costs of the co-operation; (d) the direct costs of specific projects linked to the implementation of a business plan an environmental plan, a forest management plan or equivalent, a local development strategy other than the one referred to in Article 33 of Regulation (EU) No 1303/2013 or direct costs of other actions targeted towards innovation, including testing; (e) the cost of promotion activities. 6. Where a business plan or an environmental plan or a forest management plan or equivalent or a development strategy is implemented, Member States may grant the aid either as a global amount covering the costs of co-operation and the costs of the projects implemented or cover only the costs of the co- operation and use funds from other measures or other Union Funds for project implementation. Where support is paid as a global amount and the project implemented is of a type covered under another measure of this Regulation, the relevant maximum amount or rate of support shall apply. 7. Co-operation among actors located in different regions or Member States shall also be eligible for support. 8. Support shall be limited to a maximum period of seven years except for collective environmental action in duly justified cases. 9. Co-operation under this measure may be combined with projects supported by Union funds other than the EAFRD in the same territory. Member States shall ensure that overcompensation as a result of the combination of this measure with other national or Union support instruments is avoided. 10. In order to ensure the efficient use of EAFRD budgetary resources, the Commission shall be empowered to adopt delegated acts in accordance with Article 83, concerning the further specification of the characteristics of pilot projects, clusters, networks, short supply chains and local markets that will be eligible for support, as well as concerning the conditions for granting aid to the types of operation listed in paragraph 2 of this Article. Article 36 Risk management 1. Support under this measure shall cover: (a) financial contributions to premiums for crop, animal and plant insurance against economic losses to farmers caused by adverse climatic events, animal or plant diseases, pest infestation, or an environmental incident; (b) financial contributions to mutual funds to pay financial compensations to farmers, for economic losses caused by adverse climatic events or by the outbreak of an animal or plant disease or pest infestation or an environmental incident; (c) an income stabilisation tool, in the form of financial contributions to mutual funds, providing compensation to farmers for a severe drop in their income. 2. For the purposes of this article, \"farmer\" means active farmer within the meaning of Article 9 of Regulation (EU) No 1307/2013. 3. For the purpose of points (b) and (c) of paragraph 1, 'mutual fund' means a scheme accredited by the Member State in accordance with its national law for affiliated farmers to insure themselves, whereby compensation payments are made to affiliated farmers for economic losses caused by the outbreak of adverse climatic events or an animal or plant disease or pest infestation or an environmental incident, or for a severe drop in their income. 4. Member States shall ensure that overcompensation as a result of the combination of this measure with other national or Union support instruments or private insurance schemes is avoided. 5. In order to ensure the efficient use of EAFRD budgetary resource, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the minimum and maximum duration of the commercial loans to mutual funds referred to in point (b) of Article 38(3) and Article 39(4). The Commission shall present a report on the implementation of this Article to the European Parliament and the Council by 31 December 2018. Article 37 Crop, animal, and plant insurance 1. Support under point (a) of Article 36(1) shall only be granted for insurance contracts which cover for loss caused by an adverse climatic event, or by an animal or plant disease, or a pest infestation, or an environmental incident or a measure adopted in accordance with Directive 2000/29/EC to eradicate or contain a plant disease, or pest which destroys more than 30 % of the average annual production of the farmer in the preceding three-year period or a three-year average based on the preceding five-year period, excluding the highest and lowest entry. Indexes may be used in order to calculate the annual production of the farmer. The calculation method used shall permit the determination of the actual loss of an individual farmer in a given year. The measurement of the extent of the loss caused may be tailored to the specific characteristics of each type of product using: (a) biological indexes (quantity of biomass loss) or equivalent yield loss indexes established at farm, local, regional or national level, or (b) weather indexes (including quantity of rainfall and temperature) established at local, regional or national level. 2. The occurrence of an adverse climatic event or the outbreak of an animal or plant disease or pest infestation or an environmental incident has to be formally recognised as such by the competent authority of the Member State concerned. Member States may, where appropriate, establish in advance criteria on the basis of which such formal recognition shall be deemed to be granted. 3. As regards animal diseases, financial compensation under point (a) of Article 36(1) may only be granted in respect of diseases mentioned in the list of animal diseases established by the World Organisation for Animal Health or in the Annex to Decision 2009/470/EC. 4. Insurance payments shall compensate for not more than the total of the cost of replacing the losses referred to in point (a) of Article 36(1) and shall not require or specify the type or quantity of future production. Member States may limit the amount of the premium that is eligible for support by applying appropriate ceilings. 5. Support shall be limited to the maximum rate laid down in Annex II. Article 38 Mutual funds for adverse climatic events, animal and plant diseases, pest infestations and environmental incidents 1. In order to be eligible for support the mutual fund concerned shall: (a) be accredited by the competent authority in accordance with national law; (b) have a transparent policy towards payments into and withdrawals from the fund; (c) have clear rules attributing responsibilities for any debts incurred. 2. Member States shall define the rules for the constitution and management of the mutual funds, in particular for the granting of compensation payments and the eligibility of farmers in the event of crisis, as well as for the administration and monitoring of compliance with these rules. Member States shall ensure that the fund arrangements provide for penalties in case of negligence on the part of the farmer. The occurrence of incidents mentioned in point (b) of Article 36(1) must be formally recognised as such by the competent authority of the Member State concerned. 3. The financial contributions referred to in Article 36(1)(b) may only relate to: (a) the administrative costs of setting up the mutual fund, spread over a maximum of three years in a degressive manner; (b) the amounts paid by the mutual fund as financial compensation to farmers. In addition, the financial contribution may relate to interest on commercial loans taken out by the mutual fund for the purpose of paying the financial compensation to farmers in case of crisis. Support under point (b) of Article 36(1) shall only be granted to cover for loss caused by the outbreak of adverse climatic events, an animal or plant disease, a pest infestation, or a measure adopted in accordance with Directive 2000/29/EC to eradicate or contain a plant disease or pest or an environmental incident, which destroy more than 30 % of the average annual production of the farmer in the preceding three-year period or a three-year average based on the preceding five-year period, excluding the highest and lowest entry. Indexes may be used in order to calculate the annual production of the farmer. The calculation method used shall permit the determination of the actual loss of an individual farmer in a given year. No contribution by public funds shall be made to initial capital stock. 4. As regards animal diseases, financial compensation under point (b) of Article 36(1) may be granted in respect of diseases mentioned in the list of animal diseases established by the World Organisation for Animal Health or in the Annex to Decision 2009/470/EC. 5. Support shall be limited to the maximum support rate laid down in Annex II. Member States may limit the costs that are eligible for support by applying: (a) ceilings per fund; (b) appropriate per unit ceilings. Article 39 Income stabilisation tool 1. Support under point (c) of Article 36(1) shall only be granted where the drop of income exceeds 30 % of the average annual income of the individual farmer in the preceding three-year period or a three-year average based on the preceding five-year period excluding the highest and lowest entry. Income for the purposes of point (c) of Article 36(1) shall refer to the sum of revenues the farmer receives from the market, including any form of public support, deducting input costs. Payments by the mutual fund to farmers shall compensate for less than 70 % of the income lost in the year the producer becomes eligible to receive this assistance. 2. In order to be eligible for support the mutual fund concerned shall: (a) be accredited by the competent authority in accordance with national law; (b) have a transparent policy towards payments into and withdrawals from the fund; (c) have clear rules attributing responsibilities for any debts incurred. 3. Member States shall define the rules for the constitution and management of the mutual funds, in particular for the granting of compensation payments to farmers in the event of crisis and for the administration and monitoring of compliance with these rules. Member States shall ensure that the fund arrangements provide for penalties in case of negligence on the part of the farmer. 4. The financial contributions referred to in point (c) of Article 36(1) may only relate to: (a) the administrative costs of setting up the mutual fund, spread over a maximum of three years in a degressive manner; (b) the amounts paid by the mutual fund as financial compensation to farmers. In addition, the financial contribution may relate to interest on commercial loans taken out by the mutual fund for the purpose of paying the financial compensation to farmers in case of crisis. No contribution by public funds shall be made to initial capital stock. 5. Support shall be limited to the maximum rate laid down in Annex II. Article 40 Financing of complementary national direct payments for Croatia 1. Support may be granted to farmers eligible for complementary national direct payments under Article 19 of Regulation (EU) No 1307/2013. The conditions laid down in that Article shall also apply to the support to be granted under this Article. 2. The support granted to a farmer in respect of the years 2014, 2015 and 2016 shall not exceed the difference between: (a) the level of direct payments applicable in Croatia for the year concerned in accordance with Article 17 of Regulation (EU) No 1307/2013; and (b) 45 % of the corresponding level of the direct payments as applied from 2022. 3. The Union contribution to support granted under this Article in Croatia in respect of the years 2014, 2015 and 2016 shall not exceed 20 % of its respective total annual EAFRD allocation. 4. The EAFRD contribution rate for the complements to direct payments shall not exceed 80 %. Article 41 Rules on the implementation of the measures The Commission shall adopt implementing acts, laying down rules on the implementation of the measures in this section concerning: (a) procedures for selection of authorities or bodies offering farm and forestry advisory services, farm management or farm relief services and the degressivity of the aid under the advisory services measure referred to in Article 15; (b) the assessment by the Member State of the progress of the business plan, payment options as well as modalities for access to other measures for young farmers under the farm and business development measure referred to in Article 19; (c) conversion to units other than those used in Annex II, and conversion rates of animals to livestock units (LU) under the measures referred to in Articles 28, 29, 33 and 34; (d) the possibility of using standard assumptions of additional costs and income foregone under the measures of Articles 28 to 31, 33 and 34 and criteria for its calculation; (e) calculation of the amount of support where an operation is eligible for support under more than one measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. LEADER Article 42 LEADER local action groups 1. In addition to the tasks referred to in Article 34 of Regulation (EU) No 1303/2013 local action groups may also perform additional tasks delegated to them by the Managing Authority and/or the paying agency. 2. Local action groups may request the payment of an advance from the competent paying agency if such possibility is provided for in the rural development programme. The amount of the advances shall not exceed 50 % of the public support related to the running and animation costs. Article 43 LEADER start-up kit Support for LEADER local development may also include a \"LEADER start-up kit\" for local communities who did not implement LEADER in the 2007-2013 programming period. The \"LEADER start-up kit\" shall consist of support for capacity building and small pilot projects. Support under the \"LEADER start-up kit\" shall not be conditional on the submission of a LEADER local development strategy. Article 44 LEADER co-operation activities 1. The support referred to in point (c) of Article 35(1) of Regulation (EU) No 1303/2013 shall be granted to (a) co-operation projects within a Member State (inter-territorial co-operation) or co-operation projects between territories in several Member States or with territories in third countries (transnational co-operation). (b) preparatory technical support for inter-territorial and transnational co-operation projects, on condition that local action groups are able to demonstrate that they are envisaging the implementation of a concrete project. 2. Apart from other local action groups, the partners of a local action group under the EAFRD may be: (a) a group of local public and private partners in a rural territory that is implementing a local development strategy within or outside the Union; (b) a group of local public and private partners in a non- rural territory that is implementing a local development strategy. 3. In cases where co-operation projects are not selected by the local action groups, Member States shall establish a system of ongoing application. They shall make public the national or regional administrative procedures concerning the selection of transnational co-operation projects and a list of eligible costs at the latest two years after the date of approval of their rural development programmes. Approval of co-operation projects by the competent authority shall take place no later than four months after the date of submission of the project application. 4. Member States shall communicate to the Commission the approved transnational co-operation projects. CHAPTER II Common provisions for several measures Article 45 Investments 1. In order to be eligible for EAFRD support, investment operations shall be preceded by an assessment of the expected environmental impact in accordance with law specific to that kind of investment where the investment is likely to have negative effects on the environment. 2. Expenditure that is eligible for EAFRD support shall be limited to: (a) the construction, acquisition, including leasing, or improvement of immovable property; (b) the purchase or lease purchase of new machinery and equipment up to the market value of the asset; (c) general costs linked to expenditure referred to in points (a) and (b), such as architect, engineer and consultation fees, fees relating to advice on environmental and economic sustainability, including feasibility studies. Feasibility studies shall remain eligible expenditure even where, based on their results, no expenditure under points (a) and (b) is made; (d) the following intangible investments: acquisition or development of computer software and acquisitions of patents, licenses, copyrights, trademarks; (e) the costs of establishing forest management plans and their equivalent. 3. In the case of agricultural investments, the purchase of agricultural production rights, payment entitlements, animals, annual plants and their planting shall not be eligible for investment support. However, in case of the restoration of agricultural production potential damaged by natural disasters or catastrophic events, in accordance with point (b) of Article 18(1), expenditure for the purchase of animals may be eligible expenditure. 4. Beneficiaries of investment related support may request the payment of an advance of up to 50 % of the public aid related to the investment from the competent paying agencies if that option is included in the rural development programme. 5. Working capital that is ancillary to, and linked to a new investment in the agriculture or forestry sector, which receives EAFRD support through a financial instrument established in accordance with Article 37 of Regulation (EU) No 1303/2013, may be eligible expenditure. Such eligible expenditure shall not exceed 30 % of the total amount of the eligible expenditure for the investment. The relevant request shall be duly substantiated. 6. In order to take account of the special characteristics of particular types of investments, the Commission shall be empowered to adopt delegated acts in accordance with Article 83, laying down the conditions under which other costs connected with leasing contracts, second hand equipment may be considered to be eligible expenditure and specifying the types of renewable energy infrastructure that are to be eligible for support. Article 46 Investments in irrigation 1. Without prejudice to Article 45 of this Regulation, in the case of irrigation in new and existing irrigated areas, only investments that fulfil the conditions in this Article shall be considered as eligible expenditure. 2. A river basin management plan, as required under the terms of the Water Framework Directive, shall have been notified to the Commission for the entire area in which the investment is to take place, as well as in any other areas whose environment may be affected by the investment. The measures taking effect under the river basin management plan in accordance with Article 11 of the Water Framework Directive and of relevance to the agricultural sector shall have been specified in the relevant programme of measures. 3. Water metering enabling measurement of water use at the level of the supported investment shall be in place or shall be put in place as part of the investment. 4. An investment in an improvement to an existing irrigation installation or element of irrigation infrastructure shall be eligible only if it is assessed ex ante as offering potential water savings of a minimum of between 5 % and 25 % according to the technical parameters of the existing installation or infrastructure. If the investment affects bodies of ground- or surface water whose status has been identified as less than good in the relevant river basin management plan for reasons related to water quantity: (a) the investment shall ensure an effective reduction in water use, at the level of the investment, amounting to at least 50 % of the potential water saving made possible by the investment; (b) in the case of an investment on a single agricultural holding, it shall also result in a reduction to the holding's total water use amounting to at least 50 % of the potential water saving made possible at the level of the investment. The total water use of the holding shall include water sold by the holding. None of the conditions in paragraph 4 shall apply to an investment in an existing installation which affects only energy efficiency or to an investment in the creation of a reservoir or to an investment in the use of recycled water which does not affect a body of ground or surface water. 5. An investment resulting in a net increase of the irrigated area affecting a given body of ground or surface water shall be eligible only if: (a) the status of the water body has not been identified as less than good in the relevant river basin management plan for reasons related to water quantity; and (b) an environmental analysis shows that there will be no significant negative environmental impact from the investment; such an environmental impact analysis shall be either carried out by or approved by the competent authority and may also refer to groups of holdings. Areas which are not irrigated but in which an irrigation installation was active in the recent past, to be established and justified in the programme, may be considered as irrigated areas for the purpose of determining the net increase of the irrigated area. 6. By way of derogation from point (a) of paragraph 5 investments resulting in a net increase of the irrigated area may still be eligible if: (a) the investment is combined with an investment in an existing irrigation installation or element of irrigation infrastructure assessed ex ante as offering potential water savings of a minimum of between 5 % and 25 % according to the technical parameters of the existing installation or infrastructure and (b) the investment ensures an effective reduction in water use, at the level of the investment as a whole, amounting to at least 50 % of the potential water saving made possible by the investment in the existing irrigation installation or element of infrastructure. Furthermore, by way of derogation, the condition in point (a) of paragraph 5 shall not apply to investments in the establishment of a new irrigation installation supplied with water from an existing reservoir approved by the competent authorities before 31 October 2013 if the following conditions are met: \u2014 the reservoir in question is identified in the relevant river basin management plan and is subject to the control requirements set out in article 11(3)(e) of the Water Framework Directive; \u2014 on 31 October 2013, there was in force either a maximum limit on total abstractions from the reservoir or a minimum required level of flow in water bodies affected by the reservoir; \u2014 that maximum limit or minimum required level of flow complies with the conditions set out in Article 4 of the Water Framework Directive; and \u2014 the investment in question does not result in abstractions beyond the maximum limit in force on 31 October 2013 or result in a reduction of the level of flow in affected water bodies below the minimum required level in force on 31 October 2013. Article 47 Rules for area related payments 1. The number of hectares to which a commitment pursuant to Articles 28, 29 and 34 applies may vary from year to year where: (a) this possibility is provided for in the rural development programme; (b) the commitment in question does not apply to fixed parcels; and (c) the achievement of the commitment's objective is not jeopardised. 2. Where all or part of the land under commitment or the entire holding is transferred to another person during the period of that commitment, the commitment, or part thereof corresponding to the land transferred, may be taken over for the remainder of the period by that other person or may expire and reimbursement shall not be required in respect of the period during which the commitment was effective. 3. Where a beneficiary is unable to continue to comply with commitments given because the holding or part of the holding is re-parcelled or is the subject of public land consolidation measures or land consolidation measures approved by the competent public authorities, Member States shall take the measures necessary to allow the commitments to be adapted to the new situation of the holding. If such adaptation proves impossible, the commitment shall expire and reimbursement shall not be required in respect of the period during which the commitment was effective. 4. Reimbursement of the aid received shall not be required in cases of force majeure and exceptional circumstances as referred to in Article 2 of Regulation (EU) No 1306/2013. 5. Paragraph 2, as regards cases of transfer of the entire holding, and paragraph 4 shall also apply to commitments under Article 33. 6. In order to ensure the efficient implementation of area related measures and secure the financial interests of the Union, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down conditions applicable to conversion or adjustment of commitments under the measures referred to in Articles 28, 29, 33 and 34 and, specifying other situations in which reimbursement of the aid shall not be required. Article 48 Revision clause A revision clause shall be provided for operations undertaken pursuant to Articles 28, 29, 33 and 34 in order to ensure their adjustment in the case of amendments to the relevant mandatory standards, requirements or obligations referred to in those Articles beyond which the commitments have to go. The revision clause shall also cover adjustments needed to avoid double funding of the practices referred to in Article 43 of Regulation (EU) No 1307/2013 in the case of amendments to those practices. Operations undertaken pursuant to Articles 28, 29, 33 and 34 which extend beyond the current programming period shall contain a revision clause in order to allow for their adjustment to the legal framework of the following programming period. If such adjustment is not accepted by the beneficiary, the commitment shall expire and reimbursement shall not be required in respect of the period during which the commitment was effective. Article 49 Selection of operations 1. Without prejudice to point (d) of Article 34(3) of Regulation (EU) No 1303/2013, the Managing Authority of the rural development programme shall define selection criteria for operations following consultation with the Monitoring Committee. Selection criteria shall aim to ensure equal treatment of applicants, better use of financial resources and targeting of measures in accordance with the Union priorities for rural development. In defining and applying selection criteria the principle of proportionality shall be taken into account in relation to the size of the operation. 2. The Member State authority responsible for the selection of operations shall ensure that operations, with the exception of operations under Articles 28 to 31, 33 to 34 and 36 to 39, are selected in accordance with the selection criteria referred to in paragraph 1 and according to a transparent and well documented procedure. 3. Where appropriate, the beneficiaries may be selected on the basis of calls for proposals, applying economic and environmental efficiency criteria. Article 50 Rural area definition For the purposes of this Regulation the Managing Authority shall define \"rural area\" at programme level. Member States may establish such a definition for a measure or type of operation if duly justified. CHAPTER III Technical assistance and networking Article 51 Funding technical assistance 1. In accordance with Article 6 of Regulation (EU) No 1306/2013 the EAFRD may use up to 0,25 % of its annual allocation to finance the tasks referred to in Article 58 of Regulation (EU) No 1303/2013, including the costs for setting up and operating the European network for rural development referred to in Article 52 and the EIP network referred to in Article 53 at the Commission's initiative and/or on its behalf. The EAFRD may also finance the actions provided for in Article 41(2) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council (25), in relation to Union quality scheme indications and symbols. Those actions shall be carried out in accordance with Article 58 of Regulation (EU, EURATOM) No 966/2012 of the European Parliament and of the Council (26) and any other provisions of that Regulation and of its implementing provisions that are applicable to this form of execution of the budget. 2. At the initiative of the Member States up to 4 % of the total amount of each rural development programme may be devoted to the tasks referred to in Article 59 of Regulation (EC) No 1303/2013 and costs related to preparatory work for the delimitation of areas facing natural or other specific constraints referred to in Article 32. Costs relating to the certification body referred to in Article 9 of Regulation (EU) No 1306/2013 shall not be eligible under this paragraph. Within that 4 % limit an amount shall be reserved for establishing and operating the national rural network referred to in Article 54. 3. In case of rural development programmes covering both less-developed regions and other regions, the EAFRD contribution rate for technical assistance referred to in Article 59(3) may be determined by taking into account the predominant type of regions, by their number, in the programme. Article 52 European network for rural development 1. A European network for rural development for the networking of national networks, organisations, and administrations active in the field of rural development at Union level shall be put in place in accordance with Article 51(1). 2. Networking through the European network for rural development shall aim to: (a) increase the involvement of all stakeholders, and in particular agricultural, forestry and other rural development stakeholders in the implementation of rural development; (b) improve the quality of rural development programmes; (c) play a role in informing the broader public on the benefits of rural development policy. (d) support the evaluation of rural development programmes. 3. The tasks of the network shall be to: (a) collect, analyse and disseminate information on action in the field of rural development; (b) provide support on evaluation processes and on data collection and management; (c) collect, consolidate and disseminate at Union level good rural development practices, including on evaluation methodologies and tools; (d) set up and run thematic groups and/or workshops with a view to facilitating the exchange of expertise and to supporting the implementation, monitoring and further development of rural development policy; (e) provide information on developments in rural areas of the Union and in third countries; (f) organise meetings and seminars at Union level for those actively involved in rural development; (g) support the national networks and transnational co-operation initiatives and the exchange concerning actions and experience in the field of rural development with networks in third countries; (h) specifically for local action groups: (i) create synergies with the activities carried out at national or regional level, or at both by the respective networks with regard to capacity building actions and exchange of experience; and (ii) cooperate with the networking and technical support bodies for local development set up by the ERDF, the ESF and the EMFF as regards their local development activities and transnational co-operation. 4. The Commission shall adopt implementing acts, setting out the organisational structure and operation of the European network for rural development network. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. Article 53 European Innovation Partnership network 1. A EIP network shall be put in place to support the EIP for agricultural productivity and sustainability referred to in Article 55, in accordance with Article 51(1). It shall enable the networking of operational groups, advisory services and researchers. 2. The aim of the EIP network shall be to: (a) facilitate the exchange of expertise and good practices; (b) establish a dialogue between farmers and the research community and facilitate the inclusion of all stakeholders in the knowledge exchange process. 3. The tasks of the EIP network shall be to: (a) provide a help desk function and provide information to key actors concerning the EIP; (b) encourage the setting up of operational groups and provide information about the opportunities provided by Union policies; (c) facilitate the setting up of cluster initiatives and pilot or demonstration projects which may relate, inter alia, to the following issues:: (i) increased agricultural productivity, economic viability, sustainability, output and resource efficiency; (ii) innovation in support of the bio-based economy; (iii) biodiversity, ecosystem services, soil functionality and sustainable water management; (iv) innovative products and services for the integrated supply chain; (v) opening up new product and market opportunities for primary producers; (vi) food quality, food safety and healthy diet; (vii) reduce post-harvest losses and food wastage. (d) Collect and disseminate information in the field of the EIP, including research findings and new technologies relevant to innovation and knowledge exchange and exchanges in the field of innovation with third countries. 4. The Commission shall adopt implementing acts, setting out the organisational structure and operation of the EIP network. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. Article 54 National rural network 1. Each Member State shall establish a national rural network, which groups the organisations and administrations involved in rural development. The partnership referred to in Article 5 of Regulation (EU) No 1303/2013 shall also be part of the national rural network. Member States with regional programmes may submit for approval a specific programme for the establishment and the operation of their national rural network. 2. Networking by the national rural network shall aim to: (a) increase the involvement of stakeholders in the implementation of rural development; (b) improve the quality of implementation of rural development programmes; (c) inform the broader public and potential beneficiaries on rural development policy and funding opportunities; (d) foster innovation in agriculture, food production, forestry and rural areas. 3. EAFRD support under Article 51(3) shall be used: (a) for the structures needed to run the network; (b) for the preparation and implementation of an action plan covering at least the following: (i) activities regarding the collection of examples of projects covering all priorities of the rural development programmes; (ii) activities regarding the facilitation of thematic and analytical exchanges between rural development stakeholders, sharing and dissemination of findings; (iii) activities regarding the provision of training and networking for local action groups and in particular technical assistance for inter-territorial and transnational co-operation, facilitation of co-operation among local action groups and the search of partners for the measure referred to in Article 35; (iv) activities regarding the provision of networking for advisors and innovation support services; (v) activities regarding the sharing and dissemination of monitoring and evaluation findings; (vi) a communication plan including publicity and information concerning the rural development programme in agreement with the Managing Authorities and information and communication activities aimed at a broader public; (vii) activities regarding the participation in and contribution to the European network for rural development. 4. The Commission shall adopt implementing acts, laying down rules for the establishment and operation of national rural networks and the content of the specific programmes referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. TITLE IV EIP FOR AGRICULTURAL PRODUCTIVITY AND SUSTAINABILITY Article 55 Aims 1. The EIP for agricultural productivity and sustainability shall: (a) promote a resource efficient, economically viable, productive, competitive, low emission, climate friendly and resilient agricultural and forestry sector, working towards agro-ecological production systems and working in harmony with the essential natural resources on which farming and forestry depend; (b) help deliver a steady and sustainable supply of food, feed and biomaterials, including existing and new types; (c) improve processes to preserve the environment, adapt to climate change and mitigate it; (d) build bridges between cutting-edge research knowledge and technology and farmers, forest managers, rural communities, businesses, NGOs and advisory services. 2. The EIP for agricultural productivity and sustainability shall seek to achieve its aims by: (a) creating added value by better linking research and farming practice and encouraging the wider use of available innovation measures; (b) promoting the faster and wider transposition of innovative solutions into practice; and (c) informing the scientific community about the research needs of farming practice. 3. The EAFRD shall contribute to the aims of the EIP for agricultural productivity and sustainability through support, in accordance with Article 35, of the EIP operational groups referred to in Article 56 and the EIP network referred to in Article 53. Article 56 Operational groups 1. EIP operational groups shall form part of the EIP for agricultural productivity and sustainability. They shall be set up by interested actors such as farmers, researchers, advisors and businesses involved in the agriculture and food sector, who are relevant for achieving the objectives of the EIP. 2. EIP operational groups shall establish internal procedures that ensure, that their operation and decision-making is transparent and that situations of conflict of interest are avoided. 3. The Member States shall decide within the framework of their programmes to what extent they will support the operational groups. Article 57 Tasks of operational groups 1. EIP operational groups shall draw up a plan that contains the following: (a) a description of the innovative project to be developed, tested, adapted or implemented; (b) a description of the expected results and the contribution to the EIP objective of enhancing productivity and sustainable resource management. 2. When implementing their innovative projects operational groups shall: (a) make decisions on the elaboration and implementation of innovative actions; and (b) implement innovative actions through measures financed through the rural development programmes. 3. Operational groups shall disseminate the results of their project, in particular through the EIP network. TITLE V FINANCIAL PROVISIONS Article 58 Resources and their distribution 1. Without prejudice to paragraphs 5, 6 and 7 of this Article, the total amount of Union support for rural development under this Regulation for the period from 1 January 2014 to 31 December 2020 shall be EUR 84 936 million, in 2011 prices, in accordance with the multiannual financial framework for the years 2014 to 2020. 2. 0,25 % of the resources referred to in paragraph 1 shall be devoted to technical assistance for the Commission, as referred to in Article 51(1). 3. For the purpose of their programming and subsequent inclusion in the general budget of the Union, the amounts referred to in paragraph 1 shall be indexed at 2 % per year. 4. The annual breakdown by Member State of the amounts referred to in paragraph 1, after deduction of the amount referred to in paragraph 2 is set out in Annex I. 5. Funds transferred by a Member State under Article 14(2) of Regulation (EU) No 1306/2013 shall be subtracted from the amounts allocated to that Member State in accordance with paragraph 4. 6. The funds transferred to the EAFRD in application of Articles 7(2) and 14(1) of Regulation (EU) No 1307/2013 and the funds transferred to the EAFRD in application of Articles 10b and 136 of Council Regulation (EC) No 73/2009 (27) in respect of calendar year 2013 shall also be included in the annual breakdown referred to in paragraph 4. 7. In order to take account of the developments relating to the annual breakdown referred to in paragraph 4, including the transfers referred to in paragraphs 5 and 6; to make technical adjustments without changing the overall allocations; or to take account of any other change provided for by a legislative act after the adoption of this Regulation, the Commission shall be empowered to adopt delegated acts, in accordance with Article 83, to review the ceilings set out in Annex I. 8. For the purposes of the allocation of the performance reserve referred to in Article 22(3) and (4) of Regulation (EU) No 1303/2013, available assigned revenue collected in accordance with Article 43 of Regulation (EU) No 1306/2013 for the EAFRD shall be added to the amounts referred to in Article 20 of Regulation (EU) No 1303/2013. That available assigned revenue shall be allocated to Member States in proportion to their share of the total amount of support from the EAFRD. Article 59 Fund contribution 1. The decision approving a rural development programme shall set the maximum contribution from the EAFRD to the programme. The decision shall clearly identify, where necessary, the appropriations allocated to the less developed regions. 2. The EAFRD contribution shall be calculated on the basis of the amount of eligible public expenditure. 3. The rural development programmes shall establish a single EAFRD contribution rate applicable to all measures. Where applicable, a separate EAFRD contribution rate shall be established for less-developed regions, for outermost regions and for the smaller Aegean islands within the meaning of Regulation (EEC) No 2019/93, as well as for transition regions. The maximum EAFRD contribution rate shall be: (a) 85 % of the eligible public expenditure in the less developed regions, in the outermost regions and in the smaller Aegean islands within the meaning of Regulation (EEC) No 2019/93; (b) 75 % of the eligible public expenditure for all regions whose GDP per capita for the 2007-2013 period was less than 75 % of the average of the EU-25 for the reference period but whose GDP per capita is above 75 % of the GDP average of the EU-27; (c) 63 % of the eligible public expenditure for the transition regions other than those referred to in point (b) of this paragraph; (d) 53 % of the eligible public expenditure in the other regions. The minimum EAFRD contribution rate shall be 20 %. 4. By way of derogation from paragraph 3, the maximum EAFRD contribution shall be: (a) 80 % for the measures referred to in Articles 14, 27 and 35, for the LEADER local development referred to in Article 32 of Regulation (EU) No 1303/2013 and for operations under point (a)(i) of Article 19(1). That rate may be increased to a maximum of 90 % for the programmes of less developed, the outermost regions, of the smaller Aegean islands within the meaning of Regulation (EEC) No 2019/93 and of transition regions referred to in points (b) and (c) of paragraph 3; (b) 75 % for operations contributing to the objectives of environment and climate change mitigation and adaptation under Article 17, points (a) and (b) of Article 21(1), Articles 28 29, 30 31 and 34. (c) 100 % for Union-level financial instruments referred to in point (a) of Article 38(1) of Regulation 1303/2013; (d) the contribution rate applicable to the measure concerned increased by an additional 10 percentage points for contributions to financial instruments referred to in point (b) of Article 38(1) of Regulation 1303/2013. (e) 100 % for operations receiving funding from funds transferred to the EAFRD in application of Article 7(2) and Article 14(1) of Regulation (EU) No 1306/2013. (f) 100 % for an amount of EUR 500 million, in 2011 prices, allocated to Portugal and for an amount of EUR 7 million, in 2011 prices, allocated to Cyprus on condition that those Member States are receiving financial assistance in accordance with Articles 136 and 143 TFEU on 1 January 2014 or thereafter, until 2016, when the application of this provision shall be reassessed. (g) For Member States receiving on 1 January 2014 or thereafter financial assistance in accordance with Article 136 and 143 TFEU, the EAFRD contribution rate resulting from the application of Article 24(1) of Regulation (EU) No 1303/2013 may be increased by a maximum of an additional 10 percentage points up to a total maximum of 95 %, for expenditure to be paid by these Member States in the first two years of implementation of the rural development programme. The EAFRD contribution rate which would be applicable without this derogation shall, however, be respected for the total public expenditure made during the programming period. 5. At least 5 %, and in the case of Croatia 2,5 %, of the total EAFRD contribution to the rural development programme shall be reserved for LEADER. 6. At least 30 % of the total EAFRD contribution to the rural development programme shall be reserved for measures under the following Articles: Article 17 for environment and climate related investments; Articles 21, 28, 29 and 30, with the exception of Water Framework Directive related payments; and Articles 31, 32 and 34. The first subparagraph shall not apply to the outermost regions and the overseas territories of the Member States. 7. Where a Member State submits both a national programme and a set of regional programmes, paragraphs 5 and 6 shall not apply to the national programme. The EAFRD contribution to the national programme shall be taken into account for the purpose of calculating the percentages referred to in paragraphs 5 and 6 for each regional programme, in proportion to that regional programme's share of the national allocation. 8. An expenditure co-financed by the EAFRD shall not be co-financed by way of a contribution from the Structural Funds, from the Cohesion Fund or from any other Union financial instrument. 9. Public expenditure on aid to enterprises shall comply with the aid limits laid down in respect of State aid, unless this Regulation provides otherwise. Article 60 Eligibility of expenditure 1. By way of derogation from Article 65(9) of Regulation (EU) No 1303/2013, in cases of emergency measures due to natural disasters, the rural development programmes may provide that eligibility of expenditure relating to programme changes may start from the date when the natural disaster occurred. 2. Expenditure shall be eligible for an EAFRD contribution only where incurred for operations decided upon by the Managing Authority of the programme in question or under its responsibility, in accordance with selection criteria referred to in Article 49. With the exception of general costs as defined in Article 45(2)(c), in respect of investment operations under measures falling within the scope of Article 42 TFEU, only expenditure which has been incurred after an application has been submitted to the competent authority shall be considered eligible. Member States may provide in their programmes that only expenditure which has been incurred after the application for support has been approved by the competent authority shall be eligible. 3. Paragraphs 1 and 2 shall not apply to Article 51(1) and (2). 4. Payments by beneficiaries shall be supported by invoices and documents proving payment. Where this cannot be done, payments shall be supported by documents of equivalent probative value, except for forms of support under points (b), (c) and (d) of Article 67(1) of Regulation (EU) No 1303/2013. Article 61 Eligible expenditure 1. Where running costs are covered by support under this Regulation the following types of costs shall be eligible: (a) operating costs; (b) personnel costs; (c) training costs; (d) costs linked to public relations; (e) financial costs; (f) networking costs. 2. Studies shall only be eligible expenditure where they are linked to a specific operation under the programme or the specific objectives and targets of the programme. 3. Contributions in kind in the form of provision of works, goods, services, land and real estate for which no cash payment supported by invoices or documents of equivalent probative value has been made, may be eligible for support provided that the conditions of Article 69 of Regulation (EU) No 1303/2013 are fulfilled. Article 62 Verifiability and controllability of measures 1. Member States shall ensure that all the rural development measures that they intend to implement are verifiable and controllable. To this end, the Managing Authority and the paying agency of each rural development programme shall provide an ex ante assessment of the verifiability and controllability of the measures to be included in the rural development programme. The Managing Authority and paying agency shall also undertake the assessment of the verifiability and controllability of measures during the implementation of the rural development programme. Ex ante assessment and assessment during the implementation period shall take into account the results of controls in the previous and current programming period. Where the assessment reveals that the requirements of verifiability and controllability are not met, the measures concerned shall be adjusted accordingly. 2. Where aid is granted on the basis of standard costs or additional costs and income foregone, Member States shall ensure that the relevant calculations are adequate and accurate and established in advance on the basis of a fair, equitable and verifiable calculation. To this end, a body that is functionally independent from the authorities responsible for the programme implementation and possesses the appropriate expertise shall perform the calculations or confirm the adequacy and accuracy of the calculations. A statement confirming the adequacy and accuracy of the calculations shall be included in the rural development programme. Article 63 Advances 1. Payment of advances shall be subject to the establishment of a bank guarantee or an equivalent guarantee corresponding to 100 % of the amount of the advance. As regards public beneficiaries, advances shall be paid to municipalities, regional authorities and associations thereof, as well as to public law bodies. A facility provided as a guarantee by a public authority shall be considered equivalent to the guarantee referred to in the first subparagraph, provided that the authority undertakes to pay the amount covered by that guarantee if entitlement to the advance paid is not established. 2. The guarantee may be released when the competent paying agency establishes that the amount of actual expenditure corresponding to the public contribution related to the operation exceeds the amount of the advance. TITLE VI MANAGEMENT, CONTROL AND PUBLICITY Article 64 Responsibilities of the Commission To ensure, in the context of shared management, sound financial management in accordance with Article 317 TFEU, the Commission shall carry out the measures and controls laid down in Regulation (EU) No 1306/2013. Article 65 Responsibilities of the Member States 1. Member States shall adopt all the legislative, statutory and administrative provisions in accordance with Article 58(1) of Regulation (EU) No 1306/2013 in order to ensure that the Union's financial interests are protected effectively. 2. Member States shall designate, for each rural development programme, the following authorities: (a) the Managing Authority, which may be either a public or private body acting at national or regional level, or the Member State itself when it carries out that task, to be in charge of the management of the programme concerned; (b) the accredited paying agency within the meaning of Article 7 of Regulation (EU) No 1306/2013; (c) the certification body within the meaning of Article 9 of Regulation (EU) No 1306/2013. 3. Member States shall ensure, for each rural development programme, that the relevant management and control system has been set up in such a way that ensures a clear allocation and separation of functions between the Managing Authority and other bodies. Member States shall be responsible for ensuring that the systems function effectively throughout the programme period. 4. Member States shall clearly define the tasks of the Managing Authority, the Paying Agency and the local action groups under LEADER as regards to the application of eligibility and selection criteria and the project selection procedure. Article 66 Managing Authority 1. The Managing Authority shall be responsible for managing and implementing the programme in an efficient, effective and correct way and in particular for: (a) ensuring that there is an appropriate secure electronic system to record, maintain, manage and report statistical information on the programme and its implementation required for the purposes of monitoring and evaluation and, in particular, information required to monitor progress towards the defined objectives and priorities; (b) providing the Commission, by 31 January and 31 October in each year of the programme, with relevant indicator data on operations selected for funding, including information on output and financial indicators; (c) ensuring that beneficiaries and other bodies involved in the implementation of operations: (i) are informed of their obligations resulting from the aid granted, and maintain either a separate accounting system or an adequate accounting code for all transactions relating to the operation; (ii) are aware of the requirements concerning the provision of data to the Managing Authority and the recording of outputs and results; (d) ensuring that the ex ante evaluation referred to in Article 55 of Regulation (EU) No 1303/2013 conforms to the evaluation and monitoring system and accepting and submitting it to the Commission; (e) ensuring that the evaluation plan referred to in Article 56 of Regulation (EU) No 1303/2013 is in place, that the ex post programme evaluation referred to in Article 57 of Regulation (EU) No 1303/2013 is conducted within the time limits laid down in that Regulation, ensuring that such evaluations conform to the monitoring and evaluation system and submitting them to the Monitoring Committee and the Commission; (f) providing the Monitoring Committee with the information and documents needed to monitor implementation of the programme in the light of its specific objectives and priorities; (g) drawing up the annual progress report, including aggregate monitoring tables, and, after approval by the Monitoring Committee, submitting it to the Commission; (h) ensuring that the paying agency receives all necessary information, in particular on the procedures operated and any controls carried out in relation to operations selected for funding, before payments are authorised; (i) ensuring publicity for the programme, including through the national rural network, by informing potential beneficiaries, professional organisations, the economic and social partners, bodies involved in promoting equality between men and women, and the non-governmental organisations concerned, including environmental organisations, of the possibilities offered by the programme and the rules for gaining access to programme funding as well as by informing beneficiaries of the Union contribution and the general public on the role played by the Union in the programme. 2. The Member State or the Managing Authority may designate one or more intermediate bodies including local authorities, regional development bodies or non-governmental organisations, to carry out the management and implementation of rural development operations. When a part of its tasks is delegated to another body, the Managing Authority shall retain full responsibility for the efficiency and correctness of management and implementation of those tasks. The Managing Authority shall ensure that appropriate provisions are in place to allow the other body to obtain all necessary data and information for execution of these tasks. 3. Where a thematic sub-programme, as referred to in Article 7, is included in the rural development programme, the Managing Authority may designate one or more intermediate bodies, including local authorities, local action groups or non-governmental organisations, to carry out the management and implementation of that strategy. Paragraph 2 shall apply in this case. The managing authority shall ensure that operations and outputs of this thematic sub-programme are identified separately for the purposes of the monitoring and evaluation system referred to in Article 67. 4. Subject to the role of the paying agencies and other bodies as set out in Regulation (EU) No 1306/2013, where a Member State has more than one programme, a coordinating body may be designated with the purpose of ensuring consistency in the management of the funds and of providing a link between the Commission and the national management authorities. 5. The Commission shall adopt implementing acts, laying down uniform conditions for the application of the information and publicity requirements referred to in point (i) of paragraph 1. TITLE VII MONITORING AND EVALUATION CHAPTER I General provisions Section 1 Establishment and objectives of a monitoring and evaluation system Article 67 Monitoring and evaluation system In accordance with this Title, a common monitoring and evaluation system shall be drawn up in co-operation between the Commission and the Member States and shall be adopted by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. Article 68 Objectives The monitoring and evaluation system shall aim to: (a) demonstrate the progress and achievements of rural development policy and assess the impact, effectiveness, efficiency and relevance of rural development policy interventions; (b) contribute to better targeted support for rural development; (c) support a common learning process related to monitoring and evaluation. Section 2 Technical provisions Article 69 Common indicators 1. A list of common indicators relating to the initial situation as well as to the financial execution, outputs, results and impact of the programme and applicable to each programme shall be specified in the monitoring and evaluation system provided for in Article 67 to allow for aggregation of data at Union level. 2. The common indicators shall be based on available data and linked to the structure and objectives of the rural development policy framework and shall allow assessment of the progress, efficiency and effectiveness of policy implementation against objectives and targets at Union, national and programme level. The common impact indicators shall be based on available data. 3. The evaluator shall quantify the impact of the programme measured by the impact indicators. Based on evidence in the evaluations on the CAP, including evaluations on Rural Development programmes, the Commission shall, with the help of the Member States, assess the combined impact of all CAP instruments. Article 70 Electronic Information System Key information on the implementation of the programme, on each operation selected for funding, as well as on completed operations, needed for monitoring and evaluation, including key information on each beneficiary and project, shall be recorded and maintained electronically. Article 71 Provision of information Beneficiaries of support under rural development measures and local action groups shall undertake to provide to the Managing Authority and/or to appointed evaluators or other bodies delegated to perform functions on its behalf, all the information necessary to permit monitoring and evaluation of the programme, in particular in relation to meeting specified objectives and priorities. CHAPTER II Monitoring Article 72 Monitoring procedures 1. The Managing Authority and the Monitoring Committee referred to in Article 47 of Regulation (EU) No 1303/2013 shall monitor the quality of the implementation of the programme. 2. The Managing Authority and the Monitoring Committee shall carry out monitoring of each rural development programme by means of financial, output and target indicators. Article 73 Monitoring Committee Member States with regional programmes may establish a national Monitoring Committee to coordinate the implementation of these programmes in relation to the National Framework and the uptake of financial resources. Article 74 Responsibilities of the Monitoring Committee The Monitoring Committee shall satisfy itself as to the performance of the rural development programme and the effectiveness of its implementation. To that end, in addition to the functions referred to in Article 49 of Regulation (EU) No 1303/2013 the Monitoring Committee shall: (a) be consulted and shall issue an opinion, within four months of the decision approving the programme, on the selection criteria for financed operations, which shall be revised according to programming needs; (b) examine the activities and outputs related to the progress in the implementation of the evaluation plan of the programme; (c) examine, in particular, actions in the programme relating to the fulfilment of ex ante conditionalities, which fall within the responsibilities of the Managing Authority, and be informed of actions relating to the fulfilment of other ex ante conditionalities; (d) participate in the national rural network to exchange information on programme implementation; and (e) consider and approve the annual implementation reports before they are sent to the Commission. Article 75 Annual implementation report 1. By 30 June 2016 and by 30 June of each subsequent year until and including 2024, the Member State shall submit to the Commission an annual implementation report on implementation of the rural development programme in the previous calendar year. The report submitted in 2016 shall cover the calendar years 2014 and 2015. 2. In addition to complying with the requirements of Article 50 of Regulation (EU) No 1303/2013 annual implementation reports shall include information inter alia on financial commitments and expenditure by measure, and a summary of the activities undertaken in relation to the evaluation plan. 3. In addition to complying with the requirements of Article 50 of Regulation (EU) No 1303/2013, the annual implementation report submitted in 2017 shall also cover a description of the implementation of any sub-programmes included within the programme. 4. In addition to complying with the requirements of Article 50 of Regulation (EU) No 1303/2013, the annual implementation report submitted in 2019 shall also cover, a description of the implementation of any sub-programmes included within the programme and an assessment of progress made in ensuring an integrated approach to use of the EAFRD and other EU financial instruments to support the territorial development of rural areas, including through local development strategies. 5. The Commission shall adopt implementing acts, laying down rules concerning the presentation of the annual implementation reports. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. CHAPTER III Evaluation Article 76 General provisions 1. The Commission may adopt implementing acts, specifying the elements to be contained in the ex ante and ex post evaluations referred to in Articles 55 and 57 of Regulation (EU) No 1303/2013 and establishing the minimum requirements for the evaluation plan referred to in Article 56 of Regulation (EU) No 1303/2013. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. 2. Member States shall ensure that the evaluations are in accordance with the common evaluation approach agreed in accordance with Article 67, shall organise the production and gathering of the requisite data, and shall supply the various pieces of information provided by the monitoring system to the evaluators. 3. The evaluation reports shall be made available by the Member States on the internet and by the Commission on its website. Article 77 Ex ante evaluation Member States shall ensure that the ex ante evaluator is involved from an early stage in the process of development of the rural development programme, including in the development of the analysis referred to in Article 8(1)(b), in the design of the programme's intervention logic and in the establishment of the programme's targets. Article 78 Ex post evaluation In 2024, an ex post evaluation report shall be prepared by the Member States for each of their rural development programmes. That report shall be submitted to the Commission by 31 December 2024. Article 79 Syntheses of evaluations Syntheses at Union level of the ex ante and ex post evaluation reports shall be undertaken under the responsibility of the Commission. The syntheses of the evaluation reports shall be completed at the latest by 31 December of the year following the submission of the relevant evaluations. TITLE VIII COMPETITION PROVISIONS Article 80 Rules applying to undertakings Where support under this Regulation is granted to forms of co-operation between undertakings, it may be granted only to such forms of co-operation which comply with the competition rules as they apply by virtue of Articles 206 to 210 of the Regulation of the European Parliament and the Council (EU) No 1308/2013. Article 81 State aid 1. Save as otherwise provided for in this Title, Articles 107, 108 and 109 TFEU shall apply to support for rural development by Member States. 2. Articles 107, 108 and 109 TFEU shall not apply to payments made by Member States pursuant to, and in conformity with, this Regulation, or to additional national financing referred to in Article 82, within the scope of Article 42 TFEU. Article 82 Additional national financing Payments made by Member States in relation to operations falling within the scope of Article 42 TFEU and intended to provide additional financing for rural development for which Union support is granted at any time during the programming period, shall be included by Member States in the rural development programme as provided for in paragraph 1(j) of Article 8 and, where they comply with the criteria under this Regulation, shall be approved by the Commission. TITLE IX COMMISSION POWERS, COMMON PROVISIONS AND TRANSITIONAL AND FINAL PROVISIONS CHAPTER I Commission powers Article 83 Exercise of the delegation 1. The power to adopt delegated acts referred to in Articles 2(3), Article 14(5), Article 16(5), Article 19(8), Article 22(3), Article 28(10) and (11), Article 29(6), Article 30(8), Article 33(4), Article 34(5), Article 35(10), Article 36(5), Article 45(6), Article 47(6) and Article 89 is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in in Articles 2(3), Article 14(5), Article 16(5), Article 19(8), Article 22(3), Article 28(10) and (11), Article 29(6), Article 30(8), Article 33(4), Article 34(5), Article 35(10), Article 36(5), Article 45(6), Article 47(6) and Article 89 shall be conferred on the Commission for a period of seven years from the date of entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The power to adopt delegated acts referred to in Articles 2(3), Article 14(5), Article 16(5), Article 19(8), Article 22(3), Article 28(10) and (11), Article 29(6), Article 30(8), Article 33(4), Article 34(5), Article 35(10), Article 36(5), Article 45(6), Article 47(6) and Article 89 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 2(3), Article 14(5), Article 16(5), Article 19(8), Article 22(3), Article 28(10) and (11), Article 29(6), Article 30(8), Article 33(4), Article 34(5), Article 35(10), Article 36(5), Article 45(6), Article 47(6) and Article 89 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 84 Committee procedure 1. The Commission shall be assisted by a committee called \"Rural Development Committee\". That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. CHAPTER II Common provisions Article 85 Exchange of information and documents 1. The Commission, in collaboration with the Member States, shall establish an information system to enable the secure exchange of data of common interest between the Commission and each Member State. The Commission shall adopt implementing acts, laying down rules for the operation of that system. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84. 2 The Commission shall ensure that there is an appropriate secure electronic system in which key information and report on monitoring and evaluation can be recorded, maintained and managed. Article 86 Processing and protection of personal data 1. Member States and the Commission shall collect personal data for the purpose of carrying out their respective management control, monitoring and evaluation obligations under this Regulation, and in particular those laid down in Titles VI and VII, and shall not process this data in a way which is incompatible with this purpose. 2. Where personal data are processed for monitoring and evaluation purposes under Title VII using the secure electronic system referred to in Article 85, they shall be made anonymous, and processed in aggregated form only. 3. Personal data shall be processed in accordance with the rules of Directive 95/46/EC and Regulation (EC) No 45/2001. In particular, such data shall not be stored in a form which permits identification of data subjects for longer than is necessary for the purposes for which they were collected or for which they are further processed, taking into account the minimum retention periods laid down in the applicable national and Union law. 4. Member States shall inform the data subjects that their personal data may be processed by national and Union bodies in accordance with paragraph 1 and that in this respect they enjoy the rights set out in the data protection rules of, respectively, Directive 95/46/EC and Regulation (EC) No 45/2001. 5. Articles 111 to 114 in Regulation(EU) 1306/2013 shall apply to this Article. Article 87 General CAP provisions Regulation (EU) No 1306/2013 and the provisions adopted pursuant to it shall apply in relation to the measures set out in this Regulation. CHAPTER III Transitional and final provisions Article 88 Regulation (EC) No 1698/2005 Regulation (EC) No 1698/2005 is repealed. Regulation (EC) No 1698/2005 shall continue to apply to operations implemented pursuant to programmes approved by the Commission under that Regulation before 1 January 2014. Article 89 Transitional provisions In order to facilitate the transition from the system established by Regulation (EC) No 1698/2005 to the system established by this Regulation, the Commission shall be empowered to adopt delegated acts in accordance with Article 83, laying down the conditions under which support approved by the Commission under Regulation (EC) No 1698/2005 may be integrated into support provided for under this Regulation, including for technical assistance and for the ex-post evaluations. Those delegated acts may also provide conditions for the transition from rural development support for Croatia under Regulation (EC) No 1085/2006 to support provided for under this Regulation. Article 90 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 December 2013. For the European Parliament The President M. SCHULZ For the Council The President V. JUKNA (1) Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (OJ L 277, 21.10.2005, p. 1). (2) Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 december 2013 on the financing, management and monitoring of the common agricultural policy (See page 549 of this Official Journal). (3) Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 december 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulations (EC) No 637/2008 and (EC) No 73/2009 (See page 608 of this Official Journal). (4) Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (5) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). (6) Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71). (7) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). (8) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). (9) Council Regulation (EC) No 994/98 of 7 May 1998 on the application of Articles 92 and 93 of the Treaty establishing the European Community to certain categories of horizontal State aid (OJ L 142, 14.5.1998, p. 1). (10) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (11) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (12) Council Regulation (EC) No 1085/2006 of 17 July 2006 establishing an instrument for pre-accession assistance (IPA) (OJ L 170, 29.6.2007, p. 1). (13) Regulation (EU) No 182/2011 of the European Parliament and the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (14) OJ C 35, 9.2.2012 p. 1. (15) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (see page 549 of this Official Journal). (16) Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1). (17) Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field (OJ L 155, 18.6.2009, p. 30). (18) Regulation (EU) 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1). (19) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1). (20) Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (OJ L 39, 13.2.2008, p. 16). (21) Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine- based drinks and aromatized wine-product cocktails (OJ L 149, 14.6.1991, p. 1). (22) Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1). (23) Council Regulation (EEC) No 2019/93 of 19 July1993 introducing specific measures for the smaller Aegean islands concerning certain agricultural products (OJ L 184, 27.7.1993, p. 1). (24) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (see page 671 of the Official Journal). (25) Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1). (26) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (27) Council Regulation (EC) No 73/2009 of 19 January 2009 establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers, amending Regulations (EC) No 1290/2005, (EC) No 247/2006, (EC) No 378/2007 and repealing Regulation (EC) No 1782/2003 (OJ L 30, 31.1.2009, p. 16). ANNEX I BREAKDOWN OF UNION SUPPORT FOR RURAL DEVELOPMENT (2014 TO 2020) (current prices in EUR) 2014 2015 2016 2017 2018 2019 2020 TOTAL 2014-2020 Belgium 78 342 401 78 499 837 78 660 375 78 824 076 78 991 202 79 158 713 79 314 155 551 790 759 Bulgaria 335 499 038 335 057 822 334 607 538 334 147 994 333 680 052 333 187 306 332 604 216 2 338 783 966 Czech Republic 314 349 445 312 969 048 311 560 782 310 124 078 308 659 490 307 149 050 305 522 103 2 170 333 996 Denmark 90 287 658 90 168 920 90 047 742 89 924 072 89 798 142 89 665 537 89 508 619 629 400 690 Germany 1 178 778 847 1 177 251 936 1 175 693 642 1 174 103 302 1 172 483 899 1 170 778 658 1 168 760 766 8 217 851 050 Estonia 103 626 144 103 651 030 103 676 345 103 702 093 103 728 583 103 751 180 103 751 183 725 886 558 Ireland 313 148 955 313 059 463 312 967 965 312 874 411 312 779 690 312 669 355 312 485 314 2 189 985 153 Greece 601 051 830 600 533 693 600 004 906 599 465 245 598 915 722 598 337 071 597 652 326 4 195 960 793 Spain 1 187 488 617 1 186 425 595 1 185 344 141 1 184 244 005 1 183 112 678 1 182 137 718 1 182 076 067 8 290 828 821 France 1 404 875 907 1 408 287 165 1 411 769 545 1 415 324 592 1 418 941 328 1 422 813 729 1 427 718 983 9 909 731 249 Croatia 332 167 500 332 167 500 332 167 500 332 167 500 332 167 500 332 167 500 332 167 500 2 325 172 500 Italy 1 480 213 402 1 483 373 476 1 486 595 990 1 489 882 162 1 493 236 530 1 496 609 799 1 499 799 408 10 429 710 767 Cyprus 18 895 839 18 893 552 18 891 207 18 888 801 18 886 389 18 883 108 18 875 481 132 214 377 Latvia 138 327 376 138 361 424 138 396 059 138 431 289 138 467 528 138 498 589 138 499 517 968 981 782 Lithuania 230 392 975 230 412 316 230 431 887 230 451 686 230 472 391 230 483 599 230 443 386 1 613 088 240 Luxembourg 14 226 474 14 272 231 14 318 896 14 366 484 14 415 051 14 464 074 14 511 390 100 574 600 Hungary 495 668 727 495 016 871 494 351 618 493 672 684 492 981 342 492 253 356 491 391 895 3 455 336 493 Malta 13 880 143 13 965 035 14 051 619 14 139 927 14 230 023 14 321 504 14 412 647 99 000 898 Netherlands 87 118 078 87 003 509 86 886 585 86 767 256 86 645 747 86 517 797 86 366 388 607 305 360 Austria 557 806 503 559 329 914 560 883 465 562 467 745 564 084 777 565 713 368 567 266 225 3 937 551 997 Poland 1 569 517 638 1 567 453 560 1 565 347 059 1 563 197 238 1 561 008 130 1 558 702 987 1 555 975 202 10 941 201 814 Portugal 577 031 070 577 895 019 578 775 888 579 674 001 580 591 241 581 504 133 582 317 022 4 057 788 374 Romania 1 149 848 554 1 148 336 385 1 146 793 135 1 145 218 149 1 143 614 381 1 141 925 604 1 139 927 194 8 015 663 402 Slovenia 118 678 072 119 006 876 119 342 187 119 684 133 120 033 142 120 384 760 120 720 633 837 849 803 Slovakia 271 154 575 270 797 979 270 434 053 270 062 644 269 684 447 269 286 203 268 814 943 1 890 234 844 Finland 335 440 884 336 933 734 338 456 263 340 009 057 341 593 485 343 198 337 344 776 578 2 380 408 338 Sweden 248 858 535 249 014 757 249 173 940 249 336 135 249 502 108 249 660 989 249 768 786 1 745 315 250 United Kingdom 371 473 873 370 520 030 369 548 156 368 557 938 367 544 511 366 577 113 365 935 870 2 580 157 491 Total EU-28 13 618 149 060 13 618 658 677 13 619 178 488 13 619 708 697 13 620 249 509 13 620 801 137 13 621 363 797 95 338 109 365 Technical assistance (0,25 %) 34 130 699 34 131 977 34 133 279 34 134 608 34 135 964 34 137 346 34 138 756 238 942 629 Total 13 652 279 759 13 652 790 654 13 653 311 767 13 653 843 305 13 654 385 473 13 654 938 483 13 655 502 553 95 577 051 994 ANNEX II AMOUNTS AND SUPPORT RATES Article Subject Maximum amount in EUR or rate 15(8) Advisory services, farm management and farm relief services 1 500 Per advice 200 000 Per three years for the training of advisors 16(2) Information and promotion activities 70 % Of the eligible costs of the action 16(4) Quality schemes or agricultural products and foodstuffs 3 000 Per holding per year 17(3) Investment in physical assets Agricultural sector 50 % Of the amount of eligible investment in less developed regions and in all regions whose GDP per capita for the 2007 - 2013 period was less than 75 % of the average of the EU-25 for the reference period but whose GDP per capita is above 75 % of the GDP average of the EU-27. 75 % Of the amount of eligible investment in outermost regions 75 % Of the amount of eligible investment in Croatia for the implementation of Council Directive 91/676/EEC (1) within a maximum period of four years from the date of accession pursuant to Article 3(2) and Article 5(1) of that Directive 75 % Of the amount of eligible investment in the smaller Aegean islands 40 % Of the amount of eligible investment in other regions The above rates may be increased by an additional 20 percentage points, provided that maximum combined support does not exceed 90 %, for: \u2014 Young farmers as defined in this Regulation, or who have already set up during the five years preceding the application for support; \u2014 Collective investments and integrated projects, including those linked to a merger of producer organisations; \u2014 Areas facing natural constraints and other specific as referred to in Article 32; \u2014 Operations supported in the framework of the EIP; \u2014 Investments linked to operations under Articles 28 and 29 Processing and marketing of products listed in Annex I to the TFEU 50 % Of the amount of eligible investment in less developed regions and in all regions whose GDP per capita for the 2007 - 2013 period was less than 75 % of the average of the EU-25 for the reference period but whose GDP per capita is above 75 % of the GDP average of the EU-27 75 % Of the amount of eligible investment in outermost regions 75 % Of the amount of eligible investment in the smaller Aegean islands 40 % Of the amount of eligible investment in other regions The above rates may be increased by an additional 20 percentage points, provided that maximum combined support does not exceed 90 %, for operations supported in the framework of the EIP or those linked to a merger of producer organisations 17(4) Investment in physical assets 100 % Non-productive investments and agricultural and forestry infrastructure 18(5) Restoring agricultural production potential damaged by natural disasters and introduction of appropriate prevention actions 80 % Of the amount of eligible investment costs for prevention operations carried out by individual farmers. 100 % Of the amount of eligible investment costs for prevention operations carried out collectively by more than one beneficiary. 100 % Of the amount of eligible investment costs for operations to restore agricultural land and production potential damaged by natural disasters and catastrophic events. 19(6) Farm and business development 70 000 Per young farmer under Article 19(1)(a)(i) 70 000 Per beneficiary under Article 19(1)(a)(ii) 15 000 Per small farm under Article 19(1)(a)(iii) 23(3) Establishment of agroforestry systems 80 % Of the amount of eligible investment for the establishment of agroforestry systems 26(4) Investments in forestry technologies and in processing, in mobilising and in the marketing of forestry products 65 % Of the amount of eligible investment in less developed regions 75 % Of the amount of eligible investment in outermost regions 75 % Of the amount of eligible investment in the smaller Aegean islands 40 % Of the amount of eligible investment in other regions 27(4) Setting up of producer groups and organisations 10 % As a percentage of marketed production during the first five years following recognition The support shall be degressive. 100 000 Maximum amount per year in all cases. 28(8) Agri-environment-climate 600 (2) Per ha per year for annual crops 900 (2) Per ha per year for specialised perennial crops 450 (2) Per ha per year for other land uses 200 (2) Per livestock unit (\"LU\") per year for local breeds in danger of being lost to farmers 29(5) Organic farming 600 (2) Per ha per year for annual crops 900 (2) Per ha per year for specialised perennial crops 450 (2) Per ha per year for other land uses 30(7) Natura 2000 and Water Framework Directive payments 500 (2) Per ha per year maximum in the initial period not exceeding five years 200 (2) Per ha per year maximum 50 (3) Per ha per year minimum for Water Framework Directive payments 31(3) Payments to areas facing natural or other specific constraints 25 Minimum per ha per year on average of the area of the beneficiary receiving support 250 (2) Maximum per ha per year 450 (2) Maximum per ha per year in mountain areas as defined in Article 32(2) 33(3) Animal welfare 500 Per LU 34(3) Forest-environmental and climate services and forest conservation 200 (2) Per ha per year 37(5) Crop, animal and plant insurance 65 % Of the insurance premium due 38(5) Mutual funds for adverse climatic events, animal and plant diseases, pest infestations and environmental incidents 65 % Of the eligible costs. 39(5) Income stabilisation tool 65 % Of the eligible costs (1) Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources(OJ L 375, 31.12.1991, p. 1). (2) These amounts may be increased in duly substantiated cases taking into account specific circumstances to be justified in the rural development programmes. (3) This amount may be decreased in duly substantiated cases taking into account specific circumstances to be justified in the rural development programmes. NB: The aid intensities are without prejudice to Union State aid rules. ANNEX III BIOPHYSICAL CRITERIA FOR THE DELIMITATION OF AREAS FACING NATURAL CONSTRAINTS CRITERION DEFINITION THRESHOLD CLIMATE Low Temperature (1) Length of growing period (number of days) defined by number of days with daily average temperature > 5 \u00b0C (LGPt5) or \u2264 180 days Thermal-time sum (degree-days) for Growing Period defined by accumulated daily average temperature > 5 \u00b0C \u2264 1 500 degree-days Dryness Ratio of the annual precipitation (P) to the annual potential evapotranspiration (PET) P/PET \u2264 0.5 CLIMATE AND SOIL Excess Soil Moisture Number of days at or above field capacity \u2265 230 days SOIL Limited Soil Drainage (1) Areas which are water logged for significant duration of the year Wet within 80 cm from the surface for over 6 months, or wet within 40 cm for over 11 months or Poorly or very poorly drained soil or Gleyic colour pattern within 40 cm from the surface Unfavourable Texture and Stoniness (1) Relative abundance of clay, silt, sand, organic matter (weight %) and coarse material (volumetric %) fractions \u2265 15 % of topsoil volume is coarse material, including rock outcrop, boulder or texture class in half or more (cumulatively) of the 100 cm soil surface is sand, loamy sand defined as: Silt % + (2 \u00d7 clay %) \u2264 30 % or Topsoil texture class is heavy clay (\u2265\u2265 60 % clay) or Organic soil (organic matter \u2265 30 %) of at least 40 cm or Topsoil contains 30 % or more clay, and there are vertic properties within 100 cm of the soil surface Shallow Rooting Depth Depth (cm) from soil surface to coherent hard rock or hard pan \u2264 30 cm Poor Chemical Properties (1) Presence of salts, exchangeable sodium, excessive acidity Salinity: \u2265 4 deci-Siemens per meter (dS/m) in topsoil or Sodicity: \u2265 6 Exchangeable Sodium Percentage (ESP) in half or more (cumulatively) of the 100 cm soil surface layer or Soil Acidity: pH \u2264 5 (in water) in topsoil TERRAIN Steep Slope Change of elevation with respect to planimetric distance (%) \u2265 15 % (1) Member States need only check fulfilment of this criterion against those of the thresholds that are relevant to the specific situation of an area ANNEX IV INDICATIVE LIST OF MEASURES AND OPERATIONS OF PARTICULAR RELEVANCE TO THEMATIC SUB-PROGRAMMES REFERRED TO IN ARTICLE 7 Young farmers: Business start-up aid for young farmers setting up for the first time in an agricultural holding Investments in physical assets Knowledge transfer and information actions Advisory services, farm management and farm relief services Co-operation Investments in non-agricultural activities Small farms: Business start-up aid for the development of small farms Investments in physical assets Quality schemes for agricultural products and foodstuffs Knowledge transfer and information actions Advisory services, farm management and farm relief services Co-operation Investments in non-agricultural activities Setting up of producer groups LEADER Mountain areas: Payments to areas facing natural or other specific constraints Agri-environment climate operations Co-operation Investments in physical assets Farm and business development in rural areas Quality schemes for agricultural products and foodstuffs Establishment of agroforestry systems Basic services and village renewal in rural areas Knowledge transfer and information actions Advisory services, farm management and farm relief services Setting up of producer groups LEADER Short supply chains: Co-operation Setting up of producer groups LEADER Quality schemes for agricultural products and foodstuffs Basic services and village renewal in rural areas Investments in physical assets Knowledge transfer and information actions Advisory services, farm management and farm relief services Women in rural areas: Knowledge transfer and information actions Advisory services, farm management and farm relief services Investments in physical assets Farm and business development Basic services and village renewal in rural areas Co-operation LEADER Climate change mitigation and adaptation and biodiversity: Knowledge transfer & information actions Advisory services, farm management and farm relief services Investments in physical assets Restoring agricultural production potential damaged by natural disasters and catastrophic events and introduction of appropriate prevention action Basic services & village renewal in rural areas Investments in forest area development and improvement of the viability of forests Agri-environment-climate Organic farming Natura 2000 and Water framework directive payments Payments to areas facing natural and other specific constraints (biodiversity) Forest-environmental and climate services and forest conservation Co-operation Risk management ANNEX V EX ANTE CONDITIONALITIES FOR RURAL DEVELOPMENT 1. PRIORITIES-LINKED CONDITIONALITIES EU priority for RD / CPR Thematic Objective (TO) Ex ante conditionality Criteria for fulfilment RD priority 3: promoting food chain organisation, including processing and marketing of agricultural products, animal welfare and risk management in agriculture TO 5: promoting climate change adaptation, risk prevention and management 3.1. Risk prevention and risk management: the existence of national or regional risk assessments for disaster management. taking into account climate change adaptation \u2014 A national or regional risk assessment with the following elements shall be in place: \u2014 A description of the process, methodology, methods and non-sensitive data used for risk assessment as well as of the risk-based criteria for the prioritisation of investment; \u2014 A description of single-risk and multi-risk scenarios; \u2014 Taking into account, where appropriate, national climate change adaptation strategies. RD priority 4: restoring, preserving and enhancing ecosystems related to agriculture and forestry 4.1 Good Agricultural and Environmental Conditions (GAEC): standards for good agricultural and environmental condition of land referred to in Chapter I of Title VI of Regulation (EU) 1306/2013 are established at national level \u2014 GAEC standards are defined in national law and specified in the programmes; TO 5: promoting climate change adaptation, risk prevention and management 4.2 Minimum requirements for fertilisers and plant protection products: minimum requirements for fertilisers and plant protection products referred to in Article 28 of Chapter I of Title III of this Regulation are defined at national level \u2014 minimum requirements for fertilisers and plant protection products referred to in Chapter I of Title III of this Regulation are specified in the programmes; TO 6: Preserving and protecting the environment and promoting resource efficiency 4.3 other relevant national standards: relevant mandatory national standards are defined for the purpose of Article 28 of Chapter I of Title III of this Regulation \u2014 relevant mandatory national standards are specified in the programmes; RD priority 5: promoting resource efficiency and supporting the shift towards a low carbon and climate resilient economy in the agriculture and food sectors and the forestry sector TO 4: supporting the shift towards a low-carbon economy in all sectors TO 6: Preserving and protecting the environment and promoting resource efficiency 5.1 Energy efficiency: Actions have been carried out to promote cost-effective improvements of energy end use efficiency and cost-effective investment in Energy efficiency when constructing or renovating buildings. \u2014 The actions are: \u2014 Measures to ensure minimum requirements are in place related to the energy performance of buildings consistent with Articles 3, 4 and 5 of Directive 2010/31/EU of the European Parliament and the Council (1). \u2014 Measures necessary to establish a system of certification of the energy performance of buildings consistent with Article 11 of Directive 2010/31/EU \u2014 Measures to ensure strategic planning on energy efficiency, consistent with Article 3 of Directive 2012/27 EU of the European Parliament and the Council (2). \u2014 Measures consistent with Article 13 of Directive 2006/32/EC of the European Parliament and the Council (3) on energy end-use efficiency and energy services to ensure the provision to final customers of individual meters in so far as it is technically possible, financially reasonable and proportionate in relation to the potential energy savings. 5.2 Water sector: The existence of a) a water pricing policy which provides adequate incentives for users to use water resources efficiently and b) an adequate contribution of the different water uses to the recovery of the costs of water services at a rate determined in the approved river basin management plan for investment supported by the programmes. \u2014 In sectors supported by the EAFRD, a Member State has ensured a contribution of the different water uses to the recovery of the costs of water services by sector consistent with Article 9, paragraph 1 first indent of the Water Framework Directive having regard where appropriate, to the social, environmental and economic effects of the recovery as well as the geographic and climatic conditions of the region or regions affected. 5.3 Renewable energy: Actions have been carried out to promote the production and distribution of renewable energy sources (4). \u2014 Transparent support schemes, priority in grid access or guaranteed access and priority in dispatching, as well as standard rules relating to the bearing and sharing of costs of technical adaptations which have been made public are in place consistent with Article 14(1) and Article 16(2) and (3) of Directive 2009/28/EC \u2014 A Member State has adopted a national renewable energy action plan consistent with Article 4 of Directive 2009/28/EC RD priority 6: promoting social inclusion poverty reduction and economic development in rural areas TO 2: Enhancing access to, and use and quality of, information and communication technologies (Broadband target) 6. Next Generation Network (NGN) Infrastructure: The existence of national or regional NGA Plans which take account of regional actions in order to reach the Union high-speed Internet access targets, focusing on areas where the market fails to provide an open infrastructure at an affordable cost and of a quality in line with the Union competition and State aid rules and to provide accessible services to vulnerable groups. \u2014 A national or regional NGN Plan is in place that contains: \u2014 a plan of infrastructure investments based on an economic analysis taking account of existing private and public infrastructures and planned investments; \u2014 sustainable investment models that enhance competition and provide access to open, affordable, quality and future proof infrastructure and services; \u2014 measures to stimulate private investment. (1) Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13). (2) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1). (3) Directive 2006/32/EC of the European Parliament and of the Council of 5 April 2006 on energy end-use efficiency and energy services and repealing Council Directive 93/76/EEC (OJ L 114, 27.4.2006, p. 64). (4) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, p. 16). ANNEX VI INDICATIVE LIST OF MEASURES WITH RELEVANCE TO ONE OR MORE UNION PRIORITIES FOR RURAL DEVELOPMENT Measures of particular relevance to several Union priorities Article 15 Advisory services, farm management and farm relief services Article 17 Investments in physical assets Article 19 Farm and business development Article 35 Co-operation Article 42 - 44 LEADER Measures of particular relevance to fostering knowledge transfer and innovation in agriculture, forestry, and rural areas Article 14 Knowledge transfer and information actions Article 26 Investments in forestry technologies and in processing in mobilising and in the marketing of forestry products Measures of particular relevance for enhancing the competitiveness of all types of agriculture and enhancing farm viability Article 16 Quality schemes for agricultural products and foodstuffs Measures of particular relevance to promoting food chain organisation and risk management in agriculture Article 18 Restoring agricultural production potential damaged by natural disasters and catastrophic events and introduction of appropriate prevention actions Article 24 Prevention and restoration of damage to forests from forest fires and natural disasters and catastrophic events Article 27 Setting up of producer groups Article 33 Animal welfare Article 36 Risk management Article 37 Crop, animal, and plant insurance Article 38 Mutual funds for animal and plant diseases and environmental incidents Article 39 Income stabilisation tool Measure of particular relevance to restoring, preserving and enhancing ecosystems dependent on agriculture and forestry and Promoting resource efficiency and supporting the shift towards a low carbon and climate resilient economy in agriculture, food and forestry sectors Article 21(1)(a) Afforestation and creation of woodland Article 21(1)(b) Establishment of agroforestry systems Article 21(1)(d) Investments improving the resilience and environmental value as well as the mitigation of potential forest ecosystems Article 28 Agri-environment-climate Article 29 Organic farming Article 30 Natura 2000 and Water framework directive payments Article 31 -32 Payments to areas facing natural or other specific constraints Article 34 Forest-environmental and climate services and forest conservation Measures of particular relevance to promoting social inclusion, poverty reduction and economic development in rural areas Article 20 Basic services and village renewal in rural areas Article 42 \u2013 44 LEADER", "summary": "European Agricultural Fund for Rural Development European Agricultural Fund for Rural Development SUMMARY OF: Regulation (EU) No 1305/2013 \u2014 support for rural development WHAT IS THE AIM OF THE REGULATION? The regulation: sets out how the European Agricultural Fund for Rural Development (EAFRD) contributes to the development of rural areas and the agricultural sector over the 2014-2020 period to be: resilient, competitive and innovative,climate-friendly and environmentally-balanced,socially inclusive; lays down the rules governing the EU\u2019s support for rural development, funded by the EAFRD; explains the EAFRD\u2019s objectives and how it works. It was amended by Regulation (EU) 2017/2393 which introduced a series of technical modifications to the 5 regulations relating to the EU\u2019s common agricultural policy (CAP): Regulation (EU) No 1305/2013; Regulation (EU) No 1306/2013 on financing, management and monitoring of the CAP; Regulation (EU) No 1307/2013 on rules for direct payments to farmers; Regulation (EU) No 1308/2013 on the common organisation of agricultural markets in agricultural products; Regulation (EU) No 652/2014 on management of expenditure. It was further amended by Regulation (EU) 2020/2220 which, among other things, lays down transitional provisions for implementing the EAFRD, including specific resources to help the recovery of the EU\u2019s agricultural sector and rural areas following the COVID-19 pandemic. KEY POINTS Objectives The EAFRD aims to: foster competitiveness in agriculture; ensure that natural resources are managed sustainably and that measures to tackle climate change are implemented effectively; achieve a balanced territorial development of rural areas across the EU, including creating and maintaining employment. Priorities The EU supports action to meet 6 priority objectives: fostering knowledge transfer and innovation; enhancing viability and competitiveness of all types of agriculture and the sustainable management of forests; promoting food chain organisation, including processing and marketing of agricultural products, animal welfare and risk management; restoring, preserving and enhancing ecosystems related to agriculture and forestry; promoting resource efficiency and the transition to a low-carbon economy; promoting social inclusion, poverty reduction and economic development in rural areas. EU countries and regions may also address issues of particular importance in their area such as: young farmers; small farms; mountain areas; women in rural areas; climate change mitigation, adaptation and biodiversity. Budget The EAFRD\u2019s budget was set at \u20ac99.3 billion in 2015. At least 30% of this must be used for measures to take care of the environment and combat climate change and 5% is reserved for local development strategies. Delegated Regulation (EU) 2015/791 revises the budget breakdown of EU support for rural development programmes (Annex I of Regulation (EU) No 1305/2013). 2017 amendment of the regulation Regulation (EU) 2017/2393, which has applied since 1 January 2018, aims to simplify and improve farmers\u2019 access to finance under the CAP. Among other things, it introduces: a new sector-specific income stabilisation tool providing compensation to farmers affected by a severe drop in their income; support for insurance contracts in cases where more than 20% of a farmer\u2019s average annual production is destroyed, for example due to adverse weather conditions. Implementation The regulation requires rural development policy to be consistent with other policies in this area. EU-level rules and agreements are in place to ensure that EU funding is used effectively, minimising overlaps and inconsistencies. COVID-19 pandemic Amending Regulation (EU) 2020/872 provides exceptional temporary emergency assistance to farmers and small and medium-sized enterprises (SMEs) active in processing, marketing or development of agricultural products and cotton under the EAFRD. EU Member States must target the support to beneficiaries who are most affected by the COVID-19 crisis, based on available evidence and objective and non-discriminatory selection criteria. The support must take the form of a lump sum payment to be paid by 30 June 2021, based on applications for support approved by the national competent authority by 31 December 2020. The maximum amount of support must not exceed \u20ac7,000 per farmer and \u20ac50,000 per SME. Transitional rules for the years 2021 and 2022 Amending Regulation (EU) 2020/2220, adopted in December 2020, allows for the continued application of the rules under the 2014-2020 CAP framework, and ensures the continuity of payments to farmers and other beneficiaries of support from the EAFRD in 2021 and 2022, until the new framework applies from 1 January 2023. In addition, exceptional temporary support to farmers and SMEs particularly affected by the COVID-19 crisis will tackle ongoing liquidity problems that threaten the continuity of farming and of small businesses active in the processing, marketing or development of agricultural products. The total amount of EU support for rural development from 1 January 2021 to 31 December 2022 will be a maximum of \u20ac26,896,831,880 in current prices, in accordance with the multiannual financial framework for the years 2021 to 2027. A further amount of \u20ac8,070,486,840 in current prices is to be made available as additional resources under the EAFRD for the recovery of the EU agricultural sector and rural areas for the years 2021 and 2022. The regulation lays down detailed rules on how these funds should be allocated to priorities such as economic and social development, climate action, animal welfare, etc. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND The EAFRD is one of 2 EU funds providing money to implement the CAP (the other being the European Agriculture Guarantee Fund). It supports the goals of the Europe 2020 strategy by encouraging rural development throughout the EU, working alongside other initiatives in this area to ensure the effective use of EU funding. For more information, see: Rural development \u2014 protecting the future of rural communities (European Commission). MAIN DOCUMENT Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, pp. 487-548) Successive amendments to Regulation (EU) No 1305/2013 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) 2020/1009 of 10 July 2020 amending Implementing Regulations (EU) No 808/2014 and (EU) No 809/2014 as regards certain measures to address the crisis caused by the COVID-19 outbreak (OJ L 224, 13.7.2020, pp. 1-6) Regulation (EU) 2020/872 of the European Parliament and of the Council of 24 June 2020 amending Regulation (EU) No 1305/2013 as regards a specific measure to provide exceptional temporary support under the European Agricultural Fund for Rural Development (EAFRD) in response to the COVID-19 outbreak (OJ L 204, 26.6.2020, pp. 1-3) Regulation (EU) 2019/288 of the European Parliament and of the Council of 13 February 2019 amending Regulations (EU) No 1305/2013 and (EU) No 1307/2013 as regards certain rules on direct payments and support for rural development in respect of the years 2019 and 2020 (OJ L 53, 22.2.2019, pp. 14-16) Regulation (EU) 2017/2393 of the European Parliament and of the Council of 13 December 2017 amending Regulations (EU) No 1305/2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD), (EU) No 1306/2013 on the financing, management and monitoring of the common agricultural policy, (EU) No 1307/2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy, (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products and (EU) No 652/2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material (OJ L 350, 29.12.2017, pp. 15-49) Commission Delegated Regulation (EU) No 807/2014 of 11 March 2014 supplementing Regulation (EU) No 1305/2013 of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and introducing transitional provisions (OJ L 227, 31.7.2014, pp. 1-17) See consolidated version. Commission Implementing Regulation (EU) No 808/2014 of 17 July 2014 laying down rules for the application of Regulation (EU) No 1305/2013 of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (OJ L 227, 31.7.2014, pp. 18-68) See consolidated version. Commission Implementing Regulation (EU) No 809/2014 of 17 July 2014 laying down rules for the application of Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to the integrated administration and control system, rural development measures and cross compliance (OJ L 227, 31.7.2014, pp. 69-124) See consolidated version. Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC (OJ L 189, 27.6.2014, pp. 1-32) See consolidated version. Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (OJ L 347, 20.12.2013, pp. 320-469) See consolidated version. Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, pp. 549-607) See consolidated version. Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, pp. 608-670) See consolidated version. Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, pp. 671-854) See consolidated version. last update 08.04.2021"}
{"article": "20.3.2013 EN Official Journal of the European Union L 78/41 REGULATION (EU) No 229/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 March 2013 laying down specific measures for agriculture in favour of the smaller Aegean islands and repealing Council Regulation (EC) No 1405/2006 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 42 and Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Specific measures in the agricultural sector to remedy the difficulties caused by the particular geographical situation of the smaller Aegean islands have been established by Council Regulation (EC) No 1405/2006 (3). Those measures have been implemented by means of a support programme, which constitutes an essential tool for supplying those islands with agricultural products and for supporting local agricultural production. In view of the need to update the current measures, including as a result of the entry into force of the Treaty of Lisbon, it is necessary to repeal Regulation (EC) No 1405/2006 and replace it with a new regulation. (2) The fundamental objectives which the scheme promoting the smaller Aegean islands will help to achieve need to be specified. (3) It is also necessary to specify the content of the support programme for the smaller Aegean islands (\u2018support programme\u2019), which, in accordance with the principle of subsidiarity, should be established by Greece at the most appropriate geographical level and submitted by Greece to the Commission for approval. (4) In order to more effectively achieve the objectives of the scheme promoting the smaller Aegean islands, the support programme should include measures which ensure the supply of agricultural products and the preservation and development of local agricultural production. The level of programming needs to be harmonised and the policy of partnership between the Commission and Greece needs to become systematic. The Commission should adopt procedures and indicators to ensure the smooth implementation and adequate monitoring of the programme. (5) In keeping with the principle of subsidiarity and in order to ensure flexibility, the two principles which form the basis of the programming approach adopted for the scheme promoting the smaller Aegean islands, the authorities appointed by Greece may propose amendments to the programme to bring it into line with the reality of the situation on those islands. To that end, more significant involvement on the part of the competent local and regional authorities and other stakeholders should be encouraged. Also in keeping with this approach, the procedure for amending the programme should be adapted to reflect the level of relevance of each type of amendment. (6) The particular geographical situation of some of the smaller Aegean islands imposes additional transport costs in supplying products which are essential for human consumption, for processing or as agricultural inputs. In addition, other objective factors arising as a result of insularity and distance from markets impose further constraints on economic operators and producers in those Aegean islands that severely handicap their activities. In certain cases, operators and producers suffer from \u2018double insularity\u2019, consisting of the fact that supplies are brought by way of other islands. Those handicaps can be alleviated by lowering the price of those essential products. It is therefore appropriate to introduce specific supply arrangements to guarantee supply to the smaller Aegean islands and compensate for the additional costs arising from their insularity, small size and distance from markets. (7) The problems experienced by the smaller Aegean islands are accentuated by the islands' small size. In order to guarantee the effectiveness of the measures envisaged, such measures should apply to all Aegean islands except Crete and Evia. (8) In order to achieve the goal of lowering prices in the smaller Aegean islands, mitigating the additional costs of their insularity, small size and distance from markets while maintaining the competitiveness of Union products, aid should be granted for the supply of Union products to the smaller Aegean islands. Such aid should take account of the additional cost of transport to the smaller Aegean islands and, in the case of agricultural inputs and products intended for processing, the additional costs of insularity, small size and distance from markets. (9) In order to avoid speculation which would be harmful to end-users in the smaller Aegean islands, it is important to specify that the specific supply arrangements may only apply to products of sound, fair and marketable quality. (10) Since the quantities covered by the specific supply arrangements are limited to the supply requirements of the smaller Aegean islands, those arrangements should not impair the proper functioning of the internal market. Nor should the economic advantages of the specific supply arrangements lead to diversions of trade in the products concerned. The dispatch or export of those products from the smaller Aegean islands should therefore be prohibited. However, dispatch or exportation of those products should be authorised where the advantage resulting from the specific supply arrangements is reimbursed. (11) With regard to processed products, trade between the smaller Aegean islands should be authorised and transport costs in respect of those products should be reduced, in order to allow commerce between those islands. Account should also be taken of trade flows within the context of regional commerce and traditional exports and dispatching with the rest of the Union or third countries and exports of processed products corresponding to traditional trade for all those regions should be authorised. (12) In order to achieve the objectives of the specific supply arrangements, the economic advantages of those arrangements should be reflected in production costs and should reduce prices up to the end-user stage. They should therefore be granted only on condition that they are actually passed on, and appropriate checks should be carried out. (13) Rules should be established concerning the operation of the scheme, particularly those relating to the creation of a register of operators and a system of certificates, based on the certificates referred to in Article 161 of Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (4). (14) Union policy to assist local production in the smaller Aegean islands, as established by Regulation (EC) No 1405/2006, has involved a multitude of products and measures for their production, marketing or processing. Those measures have proved effective and have ensured that agricultural activities have been maintained and developed. The Union should continue to support that production, which is a key factor in the environmental, social and economic equilibrium of the smaller Aegean islands. Experience has shown that, as in the case of rural development policy, closer partnership with the local authorities can help to address in a more targeted way the particular issues affecting the islands concerned. Support for local production should thus continue to be granted through the support programme, established for the first time by Regulation (EC) No 1405/2006. In that regard, emphasis should be placed on preserving the traditional agricultural heritage and the traditional characteristics of production methods and of local and organic products. (15) The minimum elements which should be provided under the support programme in order to establish the measures supporting local agricultural production, specifically the description of the location, of the strategy proposed, of the objectives and of the measures, should be established. The principles underlying the consistency of those measures with other Union policies should also be stated, in order to avoid any incompatibility and overlapping of aid. (16) For the purposes of applying this Regulation, it should also be possible for the support programme to contain measures for financing studies, demonstration projects, training and technical assistance. (17) Farmers on the smaller Aegean islands should be encouraged to supply quality products, and the marketing of such products should be assisted. (18) A derogation may be granted from the Commission's consistent policy of not authorising State operating aid for the production, processing, marketing and transportation of agricultural products listed in Annex I to the Treaty on the Functioning of the European Union (\u2018the Treaty\u2019) in order to mitigate the specific constraints on farming in the smaller Aegean islands as a result of their insularity, small size, mountainous terrain and climate, their economic dependency on a small number of products and their distance from markets. (19) Implementation of this Regulation should not jeopardise the level of special support from which the smaller Aegean islands have benefited up to now. In order to be able to carry out the appropriate measures, Greece should continue to have at its disposal sums equivalent to the Union support already granted under Regulation (EC) No 1405/2006. (20) Since 2007, requirements in essential products have increased in the smaller Aegean islands as a result of an increasing livestock population and demographic pressure. The proportion of the budget which Greece should be able to use for the specific supply arrangements for the smaller Aegean islands should therefore be increased. (21) In order to allow Greece to evaluate all the elements concerning the implementation of the support programme for the previous year and make it possible to submit to the Commission a complete annual evaluation report, the submission date of that report should be postponed from 30 June to 30 September of the year following the reference year. (22) The Commission should be required to submit to the European Parliament and to the Council, by 31 December 2016 at the latest and thereafter every five years, a general report on the impact of measures taken to implement this Regulation accompanied, where appropriate, by suitable recommendations. (23) In order to ensure the proper functioning of the regime introduced by this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission, in respect of supplementing or modifying certain non-essential elements of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (24) In order to ensure uniform conditions for the implementation of the programme in the smaller Aegean islands in relation to other similar schemes and to avoid unfair competition or discrimination between operators, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (5). (25) In order to allow for the prompt application of the measures envisaged, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER AND OBJECTIVES Article 1 Subject matter 1. This Regulation lays down specific measures for agriculture to mitigate the difficulties caused by the insularity, small size and distance from markets of the smaller Aegean islands (\u2018the smaller islands\u2019). 2. For the purposes of this Regulation \u2018the smaller islands\u2019 means any islands in the Aegean Sea except the islands of Crete and Evia. Article 2 Objectives 1. The specific measures provided for in Article 1 shall help to meet the following objectives: (a) guaranteed supply to the smaller islands of products essential for human consumption or for processing and as agricultural inputs by mitigating the additional costs incurred due to their insularity, small size and distance from markets; (b) the preservation and development of agricultural activities in the smaller islands, including the production, processing, marketing and transport of local raw and processed products. 2. The objectives set out in paragraph 1 shall be implemented by means of the measures referred to in Chapters III, IV and V. CHAPTER II SUPPORT PROGRAMME Article 3 Establishing the support programme 1. The measures provided for in Article 1 shall be defined by a support programme comprising: (a) specific supply arrangements as provided for in Chapter III; and (b) specific measures to assist local agricultural production as provided for in Chapter IV. 2. The support programme shall be established at the geographical level which Greece deems to be the most appropriate. It shall be prepared by the competent local and regional authorities designated by Greece, which shall submit it to the Commission for approval in accordance with Article 6 after the competent authorities and organisations at the appropriate regional level have been consulted. Article 4 Compatibility and consistency 1. Measures taken under the support programme shall comply with Union law. Such measures shall be consistent with other Union policies and with the measures taken under such policies. 2. Consistency of the measures taken under the support programme with measures implemented under other instruments of the common agricultural policy, and in particular the common organisations of markets, rural development, product quality, animal welfare and the protection of the environment, shall be ensured. In particular, no measure under this Regulation shall be financed as: (a) additional support for premium or aid schemes under a common organisation of the market, save in exceptional cases, justified by objective criteria; (b) support for research projects, measures to support research projects or measures eligible for Union financing under Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field (6); (c) support for measures within the scope of Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (7). Article 5 Content of the support programme The support programme shall comprise: (a) a schedule for the implementation of the measures and a general annual indicative financing table showing the resources to be deployed; (b) proof of the compatibility and consistency between the various measures under the programme and with the criteria and quantitative indicators to be used for monitoring and evaluation; (c) the steps taken to ensure that the programme is implemented effectively and appropriately, including the arrangements for publicity, monitoring and evaluation, and a specified set of quantified indicators for use in programme evaluation; (d) the designation of the competent authorities and bodies responsible for implementing the programme and the designation at the appropriate levels of authorities or associated bodies and socio-economic partners, and the results of consultations held. Article 6 Approval and amendments of the programme 1. The support programme is established under Regulation (EC) No 1405/2006 and is financed under the financial allocation referred to in Article 18(2) and (3). The programme comprises a forecast supply balance indicating the products, the quantities thereof and the amount of aid for supply from the Union together with a draft programme of support for local production. 2. Depending on the annual evaluation of the implementation of measures included in the support programme, Greece may submit to the Commission duly substantiated proposals for amendments to those measures within the context of the financial allocation referred to in Article 18(2) and (3), to bring them more into line with the requirements of the smaller islands and the strategy proposed. The Commission shall adopt implementing acts laying down the procedures for assessing whether the amendments proposed comply with Union law and for deciding whether to approve them. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 3. The procedures laid down by the implementing acts referred to in paragraph 2 may take account of the following elements: the importance of the modifications proposed by Greece with reference to the introduction of new measures, whether the changes to the budget allocated to the measures are substantial, changes in the quantities and in the level of aid for products in the forecast supply balances and any amendments to codes and descriptions laid down in Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (8). 4. The implementing acts referred to in paragraph 2 shall also determine, for each procedure, the frequency with which requests for amendments are to be made, as well as the time frames within which the approved amendments are to be implemented. Article 7 Monitoring and follow-up Greece shall conduct verifications by means of administrative and on-the-spot checks. The Commission shall adopt implementing acts regarding the minimum characteristics of the checks to be carried out by Greece. The Commission shall also adopt implementing acts regarding the procedures and physical and financial indicators in order to ensure that the implementation of the programmes is monitored in an effective manner. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). CHAPTER III SPECIFIC SUPPLY ARRANGEMENTS Article 8 Forecast supply balance 1. Specific supply arrangements are hereby established for the Union's agricultural products listed in Annex I to the Treaty (\u2018the agricultural products\u2019) which are essential in the smaller islands for human consumption, for the manufacture of other products or as agricultural inputs. 2. Greece shall establish, at the geographical level which it deems most appropriate, a forecast supply balance so as to quantify the annual supply requirements for the smaller islands with regard to the agricultural products. A separate forecast balance may be drawn up for the requirements of undertakings packaging and processing products intended for the local market, for consignment to the rest of the Union or for export to third countries as part of regional trade, in accordance with Article 13(2) and (3), or within the context of traditional trade flows. Article 9 Operation of the specific supply arrangements 1. Aid shall be granted to supply the smaller islands with agricultural products. The amount of the aid shall be determined for each product concerned, taking account of the additional costs of marketing products in the smaller islands, calculated from the usual ports of shipment in mainland Greece, and from the ports of islands of transit or of loading for the islands of final destination. In the case of agricultural inputs and products intended for processing, such aid should take account of the additional costs associated with insularity, small size and distance from markets. 2. The specific supply arrangements shall only apply to products of sound, fair and marketable quality. Article 10 Implementation In implementing the specific supply arrangements, account shall be taken, in particular, of the following: (a) the specific needs of the smaller islands and the precise quality requirements; (b) traditional trade flows with ports in mainland Greece and between the islands in the Aegean Sea; (c) the economic aspect of the proposed aid; (d) where applicable, the need not to obstruct the development of local products. Article 11 Certificates 1. The aid provided for in Article 9(1) shall be granted on presentation of a certificate. Certificates shall be issued only to operators entered in a register held by the competent authorities. Those certificates shall not be transferable. 2. No security shall be required when applying for a certificate. However, to the extent necessary to ensure the proper application of this Regulation, the competent authority may require a security to be lodged equal to the amount of the advantage as referred to in Article 12. In such cases, Article 34(1), (4), (5), (6), (7) and (8) of Commission Regulation (EC) No 376/2008 of 23 April 2008 laying down common detailed rules for the application of the system of import and export licences and advance fixing certificates for agricultural products (9) shall apply. The Commission shall be empowered to adopt delegated acts, in accordance with Article 21, determining the conditions for recording operators in the register and providing for the full exercise by operators of their rights to participate in the specific supply arrangements. 3. The Commission shall adopt implementing acts concerning the measures necessary to ensure the uniform application by Greece of this Article, specifically relating to the introduction of the system of certificates, and the commitment undertaken by operators at the time of registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). Article 12 Impact of advantage 1. Benefiting from the specific supply arrangements resulting from the awarding of aid shall be subject to the condition that the impact of the economic advantage is passed on up to the end-user who, as appropriate, may be the consumer in the case of products meant for direct consumption, the end processor or packager in the case of products meant for the processing or packaging industries, or farmers in the case of products used for animal feed or as agricultural inputs. The advantage referred to in the first subparagraph shall be equal to the amount of the aid. 2. In order to ensure that paragraph 1 is applied in a uniform manner, the Commission shall adopt implementing acts regarding the application of the rules set out in paragraph 1 and more specifically regarding the conditions for the monitoring, by the Member State, that the advantage has in fact been passed on up to the end-user. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). Article 13 Export to third countries and dispatch to the rest of the Union 1. The Commission shall adopt implementing acts establishing the requirements in accordance with which products covered by the specific supply arrangements may be exported to third countries or dispatched to the rest of the Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). Those requirements shall include in particular reimbursement of the aid received under the specific supply arrangements. Exports to third countries of products covered by the specific supply arrangements shall not be subject to the presentation of a certificate. 2. The first subparagraph of paragraph 1 shall not apply to products processed in the smaller islands from products that have benefited from the specific supply arrangements which are: (a) exported to third countries or dispatched to the rest of the Union within the limits of traditional exports and traditional dispatches; (b) exported to third countries as part of regional trade in accordance with the destinations and detailed provisions to be determined by the Commission; (c) dispatched between the smaller islands. Exports to third countries of products referred to in points (a) and (b) of the first subparagraph shall not be subject to the presentation of a certificate. No export refund shall be granted on the export of products referred to in points (a) and (b) of the first subparagraph. The Commission shall adopt implementing acts establishing the limits of the quantities of products referred to in point (a) and the detailed provisions referred to in point (b). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 3. Processing operations which may give rise to traditional trade exports or traditional dispatches shall fulfil, mutatis mutandis, the processing conditions applicable under customs control provided for in the relevant Union legislation, with the exception of all usual forms of handling. Article 14 Controls and penalties 1. The agricultural products which are the subject of the specific supply arrangements shall be subject to administrative checks at the time that they enter the smaller islands as well as when they are exported or dispatched. The Commission shall adopt implementing acts concerning the minimum characteristics of the checks to be carried out by Greece. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 2. Except in cases of force majeure or exceptional climatic conditions, if an operator, as referred to in Article 11, fails to comply with the commitments made in accordance with that Article, the competent authority, without prejudice to any penalties applicable under national law, shall: (a) recover the advantage granted to the operator; (b) temporarily suspend or revoke the operator's registration, depending on the seriousness of the non-compliance. 3. Except in cases of force majeure or exceptional climatic conditions, where operators, as referred to in Article 11, do not carry out the planned entry, their entitlement to apply for certificates shall be suspended by the competent authority for a period of 60 days following expiry of that certificate. After the suspension period, the issue of subsequent certificates shall be subject to the lodging of a security equal to the amount of the advantage to be granted during a period to be determined by the competent authority. The competent authority shall adopt the measures required to reutilise any quantities of products made available as a result of non-execution, partial execution or cancellation of the certificates issued or recovery of the advantage. CHAPTER IV MEASURES TO ASSIST LOCAL AGRICULTURAL PRODUCTS Article 15 Measures 1. The support programme contains the measures necessary in order to ensure continuity and development of local lines of agricultural production in the smaller islands under the scope of Part Three, Title III of the Treaty. 2. The part of the programme which includes measures to assist local agricultural production shall comprise at least the following elements: (a) a quantified description of the current agricultural production situation, taking into account the results of available evaluations, showing disparities, gaps and potential for development and the financial resources deployed; (b) a description of the strategy proposed, the priorities selected, its quantified general and operational objectives, and an appraisal showing the expected economic, environmental and social impact, including employment effects; (c) a description of the measures envisaged, and in particular aid schemes for implementing them, and, where appropriate, information on the need for any studies, demonstration projects, training or technical assistance operations relating to the preparation, implementation or adaptation of the measures concerned; (d) a list of the aid constituting direct payments in accordance with Article 2(d) of Council Regulation (EC) No 73/2009 of 19 January 2009 establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers (10); (e) the aid amount established for each measure and the provisional amount for each action in order to achieve one or more objectives for the programme. 3. The Commission shall adopt implementing acts concerning requirements for the provision of the aid described in paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 4. The programme may include measures to support production, processing, marketing and transport of raw and processed agricultural products in the smaller islands. Each measure may include a variety of actions. For each action, the programme shall define at least the following elements: (a) the beneficiaries; (b) the eligibility conditions; (c) the unit amount of aid. The Commission shall adopt delegated acts in accordance with Article 21 concerning the conditions for establishing the amount of aid awarded in respect of the support for the marketing and transport of raw and processed products outside the region in which they are produced, and, where appropriate, concerning the conditions for establishing the quantities of products subject to that aid. Article 16 Controls and wrongful payments 1. Verification of measures provided for in this Chapter shall be conducted by administrative and on-the-spot checks. 2. In the event of wrongful payments, the beneficiary concerned shall be required to reimburse the amounts in question. Article 80 of Commission Regulation (EC) No 1122/2009 of 30 November 2009 laying down detailed rules for the implementation of Council Regulation (EC) No 73/2009 as regards cross-compliance, modulation and the integrated administration and control system, under the direct support schemes for farmers provided for that Regulation, as well as for the implementation of Council Regulation (EC) No 1234/2007 as regards cross-compliance under the support scheme provided for the wine sector (11) shall apply mutatis mutandis. CHAPTER V ACCOMPANYING MEASURES Article 17 State aid 1. For the agricultural products covered by Annex I to the Treaty, to which Articles 107, 108 and 109 thereof apply, the Commission may authorise, in accordance with Article 108 of the Treaty, operating aid in the sectors producing, processing, marketing and transporting those products, with a view to alleviating the specific constraints on farming in the smaller islands as a result of their insularity, small size, mountainous terrain and climate, their economic dependency on a small number of products and their distance from markets. 2. Greece may grant additional financing for the implementation of the support programme. In such cases, Greece shall notify the Commission of the State aid and the Commission may approve it in accordance with this Regulation as part of the support programme. Aid thus notified shall be deemed to have been notified within the meaning of the first sentence of Article 108(3) of the Treaty. 3. Without prejudice to paragraphs 1 and 2 of this Article and by way of derogation from Article 180 of Regulation (EC) No 1234/2007 and Article 3 of Council Regulation (EC) No 1184/2006 of 24 July 2006 applying certain rules of competition to the production of and trade in agricultural products (12), Articles 107, 108 and 109 of the Treaty shall not apply to payments made under Chapters III and IV of this Regulation by Greece in conformity with this Regulation. CHAPTER VI FINANCIAL PROVISIONS Article 18 Financial resources 1. The measures provided for in this Regulation shall constitute intervention intended to stabilise the agricultural markets within the meaning of Article 3(1)(b) of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (13). 2. The Union shall finance the measures provided for in Chapters III and IV up to a maximum annual amount of EUR 23,93 million. 3. The amount allocated annually to finance the specific supply arrangements referred to in Chapter III shall not exceed EUR 7,11 million. The Commission shall adopt implementing acts establishing the requirements in accordance with which Greece may amend the allocation of resources allocated each year to the various products benefiting from the specific supply arrangements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 4. The Commission shall adopt delegated acts, in accordance with Article 21, concerning the conditions for determining the annual maximum amount which may be allocated to measures for financing studies, demonstration projects, training and technical assistance, provided that such allocation is reasonable and proportionate. CHAPTER VII GENERAL AND FINAL PROVISIONS Article 19 National measures Greece shall take the measures necessary to ensure compliance with this Regulation, in particular as regards checks and administrative penalties, and shall inform the Commission thereof. Article 20 Communications and reports 1. Greece shall communicate to the Commission not later than 15 February each year the appropriations made available to it which it intends to spend in the following year on implementation of the forecast supply balance and for each measure promoting local agricultural production included in the support programme. 2. Greece shall submit to the Commission no later than 30 September each year a report on the implementation of the measures provided for in this Regulation over the previous year. 3. By 31 December 2016, and thereafter every five years, the Commission shall submit a general report to the European Parliament and to the Council showing the impact of the action taken under this Regulation, accompanied, if applicable, by appropriate proposals. Article 21 Exercise of the delegation 1. The power to adopt delegated acts shall be conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 11(2), Article 15(4) and Article 18(4) shall be conferred on the Commission for a period of five years from 21 March 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 11(2), Article 15(4) and Article 18(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision to revoke in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. The delegated acts adopted pursuant to Article 11(2), Article 15(4) and Article 18(4) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they do not intend to raise any objections. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 22 Committee procedure 1. The Commission shall be assisted by the Management Committee for Direct Payments established under Article 141 of Regulation (EC) No 73/2009. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 23 Repeal Regulation (EC) No 1405/2006 is hereby repealed. References made to the repealed Regulation shall be construed as being made to this Regulation and shall be read in accordance with the correlation table set out in the Annex. Article 24 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 13 March 2013. For the European Parliament The President M. SCHULZ For the Council The President L. CREIGHTON (1) OJ C 132, 3.5.2011, p. 82. (2) Position of the European Parliament of 5 February 2013 (not yet published in the Official Journal) and decision of the Council of 25 February 2013. (3) OJ L 265, 26.9.2006, p. 1. (4) OJ L 299, 16.11.2007, p. 1. (5) OJ L 55, 28.2.2011, p. 13. (6) OJ L 155, 18.6.2009, p. 30. (7) OJ L 277, 21.10.2005, p. 1. (8) OJ L 256, 7.9.1987, p. 1. (9) OJ L 114, 26.4.2008, p. 3. (10) OJ L 30, 31.1.2009, p. 16. (11) OJ L 316, 2.12.2009, p. 65. (12) OJ L 214, 4.8.2006, p. 7. (13) OJ L 209, 11.8.2005, p. 1. ANNEX Correlation table Regulation (EC) No 1405/2006 This Regulation Article 1 Article 1 Article 2 Article 3(1) Article 3 Article 8 Article 4(1) Article 9(1) Article 4(2) Article 10 Article 4(3) Article 12(1) Article 5 Article 13 Article 7(1) Article 15(1) Article 7(2) Article 3(2) Article 8 Article 4 Article 9(a) and (b) Article 15(2) Article 9(c), (d), (e) and (f) Article 5 Article 10 Article 7 second paragraph Article 11 Article 17 Article 12 Article 18 Article 13 Article 6(1) Article 14(a) Article 6(2) to (4) Article 14(b) Article 7 first paragraph, and Article 14(1) second subparagraph, (2) and (3) Article 16 Article 19 Article 17 Article 20 Article 18 Article 23 Article 21 Article 24", "summary": "Farmers in the Aegean islands - EU support Farmers in the Aegean islands - EU support The European Union has special rules to assist agriculture in the smaller Aegean islands that are affected by geographical and economic factors. ACT Regulation (EU) No 229/2013 of the European Parliament and of the Council of 13 March 2013 laying down specific measures for agriculture in favour of the smaller Aegean islands and repealing Council Regulation (EC) No 1405/2006. SUMMARY WHAT DOES THIS REGULATION DO? It allows for special arrangements that aim to compensate these islands for the difficulties they face due to their remote location. It has two aims: 1.to guarantee the supply to these smaller islands of products that are essential for human consumption or processing, as well as agricultural inputs, at a cost that compensates for their isolation; 2.to ensure, in the longer term, the continuity and development of local production. KEY POINTS Management and budget Greece decides on the appropriate geographical level at which to establish the programme and submits it to the Commission for approval. Each year, an amount of \u20ac23.93 million (of which no more than \u20ac7.11 million can be used to finance special supply arrangements) is available from the EU budget, as laid down in Article 18(2) and (3) of the regulation. Specific supply arrangements Where these are agreed, they are granted on condition that the impact of the economic advantage is passed on to the end-user who, as appropriate, may be the consumer in the case of products meant for direct consumption, the end processor or packager in the case of products meant for the processing or packaging industries or farmers in the case of products used for animal feed or as agricultural inputs. The advantage is calculated as being equal to the amount of the aid. The managing authority may require a security to be lodged equal to the amount of the advantage. Measures to assist local agricultural products The programme may include measures to support the production, processing or sale of agricultural products in the outermost regions. Each measure may include a variety of actions. For each action, the programme must define at least the beneficiaries, the eligibility conditions and the unit amount of aid allocated to that action. Checks and penalties Products that are the subject of specific supply arrangements are checked when they enter the smaller Aegean islands, as well as when they are exported or dispatched. Where the rules are not respected, the authorities may recover the advantage granted to operators (i.e. farmers and companies that own farms) and temporarily suspend/revoke their registration. Measures to assist local agricultural products are verified by means of both administrative and on-the-spot checks. In the event of a wrongful payment, the beneficiary concerned is obliged to reimburse the amount in question. WHEN DOES THIS REGULATION APPLY? From 21 March 2013. Regulation (EU) No 229/2013 repeals Regulation (EC) No 1405/2006. For further information, see the section on POSEI programmes and specific measures in favour of the smaller Aegean islands on the European Commission\u2019s website. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 229/2013 21.3.2013 - OJ L 78, 20.3.2013, pp. 41-50 last update 16.03.2015"}
{"article": "3.2.2012 EN Official Journal of the European Union L 32/1 REGULATION (EU) No 70/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 January 2012 on statistical returns in respect of the carriage of goods by road (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 338(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Council Regulation (EC) No 1172/98 of 25 May 1998 on statistical returns in respect of the carriage of goods by road (2) has been substantially amended several times. Since further amendments are to be made, that Regulation should be recast in the interests of clarity. (2) In order to carry out the tasks entrusted to it in the context of the common transport policy, the Commission should have at its disposal comparable, reliable, synchronised, regular and comprehensive statistical data on the scale and development of the carriage of goods by road by means of vehicles registered in the Union, and on the degree of utilisation of vehicles carrying out this transport. (3) It is necessary to compile comprehensive regional statistics with regard to both the carriage of goods and vehicle journeys. (4) It is therefore appropriate to ensure that the regional origin and destination of transport within the Union is described on the same basis as national transport, and to provide a link between the carriage of goods and vehicle journeys by measuring the degree of utilisation of vehicles carrying out this transport. (5) In accordance with the principle of subsidiarity, the creation of common statistical standards allowing the production of harmonised information can be better achieved only at Union level, while data will be collected in each Member State under the authority of the bodies and institutions in charge of compiling official statistics. (6) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics (3) provides a reference framework for the provisions laid down by this Regulation, in particular those concerning access to the sources of administrative data, the cost-effectiveness of available resources and statistical confidentiality. (7) Communication of individual data, once rendered anonymous, is necessary in order to estimate the overall accuracy of the results. (8) It is important to ensure that statistical information is adequately disseminated. (9) In view of the specific geographical situation of Malta, its short-range road transport journeys, its limited road network and the disproportional burden that collecting such data would cause to the Maltese authorities, a derogation should be granted to Malta. (10) In order to take account of economic and technical developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of updating Part 1 of Annex I, except for any modifications to the optional nature of the required information, and adapting Annexes II to VII. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (11) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission\u2019s exercise of implementing powers (4), HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. Each Member State shall compile statistics for the Union on the carriage of goods by road by means of goods road transport vehicles which are registered in that Member State, and on the journeys made by such vehicles. 2. This Regulation shall not apply to the carriage of goods by road by means of: (a) goods road transport vehicles whose authorised weight or dimensions exceed the limits normally permitted in the Member States concerned; (b) agricultural vehicles, military vehicles and vehicles belonging to central or local public administrations, with the exception of goods road transport vehicles belonging to public undertakings, and in particular railway undertakings. Each Member State may exclude from the scope of this Regulation goods road transport vehicles whose load capacity or maximum permissible weight is lower than a certain limit. This limit may not exceed a load capacity of 3,5 tonnes or maximum permissible weight of 6 tonnes in the case of single motor vehicles. 3. This Regulation shall not apply to Malta, so long as the number of Maltese-registered goods road transport vehicles licensed to engage in the international carriage of goods by road does not exceed 400 vehicles. For that purpose, Malta shall submit annually to Eurostat the number of goods road transport vehicles licensed to engage in the international carriage of goods by road at the latest by the end of March following the year to which the number of goods road transport vehicles relates. Article 2 Definitions For the purposes of this Regulation, the following definitions shall apply: (a) \u2018carriage of goods by road\u2019: all transport of goods by means of a goods road transport vehicle; (b) \u2018road transport vehicle\u2019: a road vehicle fitted with an engine whence it derives its sole means of propulsion, which is normally used for carrying persons or goods by road, or for drawing, on the road, vehicles used for the carriage of persons or goods; (c) \u2018road vehicle for the transport of goods\u2019: a road vehicle designed exclusively or primarily to carry goods (lorry, trailer, semi-trailer); (d) \u2018goods road transport vehicle\u2019: any single road transport vehicle, or combination of road vehicles, namely road train or articulated vehicle, designed to carry goods; (e) \u2018lorry\u2019: a rigid road vehicle designed exclusively or primarily to carry goods; (f) \u2018road tractor\u2019: a road transport vehicle designed exclusively or primarily to haul other road vehicles which are not power-driven (mainly semi-trailers); (g) \u2018trailer\u2019: a road vehicle for the transport of goods designed to be hauled by a road transport vehicle; (h) \u2018semi-trailer\u2019: a road vehicle for the transport of goods with no front axle so designed that part of the vehicle and a substantial part of its loaded weight rest on the road tractor; (i) \u2018articulated vehicle\u2019: a road tractor coupled to a semi-trailer; (j) \u2018road train\u2019: a goods road transport vehicle coupled to a trailer or an articulated vehicle with a further trailer attached; (k) \u2018registered\u2019: the state of having been entered in a register of road transport vehicles, kept by an official body in a Member State, whether or not the registration is accompanied by the issue of a registration plate. In the case of carriage by means of a combination of road transport vehicles, namely road train or articulated vehicle, in which the goods road transport vehicle and the trailer or semi-trailer are registered in different countries, the complete vehicle shall be deemed to be registered in the country where the goods road transport vehicle is registered; (l) \u2018load capacity\u2019: maximum weight of goods declared permissible by the competent authority of the country of registration of the vehicle. When the goods road transport vehicle is a road train made up of a lorry with trailer, the load capacity of the road train is the sum of the load capacities of the lorry and the trailer; (m) \u2018maximum permissible weight\u2019: total weight of the vehicle (or vehicle combination) when stationary and ready for the road and of the weight of the load declared permissible by the competent authority of the country of registration of the vehicle; (n) \u2018Eurostat\u2019: the Commission department responsible for carrying out the tasks incumbent on the Commission in the field of the production of Union statistics. Article 3 Data collection 1. Member States shall compile statistical data relating to the following areas: (a) vehicle; (b) journey; (c) goods. 2. The statistical variables in each area, their definition and the levels within the classification used for their breakdown are set out in Annexes I to VII. 3. When determining the method to be used for compiling statistical data, Member States shall refrain from carrying out any formalities at frontiers between Member States. 4. The Commission shall be empowered to adopt, where necessary, delegated acts in accordance with Article 8 concerning the updating of Part 1 of Annex I, solely in order to take account of economic and technical developments, except for any modifications to the optional nature of the required information. The Commission shall also be empowered to adopt, where necessary, delegated acts in accordance with Article 8 concerning the adaptation of Annexes II to VII to take account of economic and technical developments. In exercising its power pursuant to this paragraph, the Commission shall ensure that any delegated acts adopted do not impose significant additional administrative burdens on the Member States and on the respondents. Article 4 Precision of statistical results Member States shall ensure that their methods for the collection and processing of statistical data are designed to ensure that the statistical results transmitted pursuant to this Regulation are sufficiently precise so as to enable the Commission to have at its disposal comparable, reliable, synchronised, regular and comprehensive statistical data, whilst taking account of the structural characteristics of road transport in the Member States. For the purpose of the first paragraph, the Commission shall, by means of implementing acts, adopt detailed technical rules regarding the precision of the statistical data required. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2). Article 5 Transmission of statistical results to Eurostat 1. Member States shall transmit to Eurostat every quarter duly verified individual data corresponding to the variables referred to in Article 3 and listed in Annex I, without indicating the name, address or registration number. Such transmission shall, where appropriate, include statistical data relating to previous quarters for which the data transmitted were provisional. 2. The Commission shall, by means of implementing acts, adopt the arrangements for transmitting the data referred to in paragraph 1, including, where appropriate, the statistical tables based on those data. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2). 3. The transmission of the data referred to in paragraph 1, shall take place within 5 months of the end of each quarterly period of observation. The first transmission shall cover the first quarter of 1999. Article 6 Dissemination of statistical results Statistical results in respect of the carriage of goods by road shall be disseminated no later than 12 months after the end of the period to which the results relate. The Commission shall, by means of implementing acts, adopt rules on the dissemination of statistical results in respect of the carriage of goods by road, including the structure and content of the results to be disseminated. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2). Article 7 Reports 1. Member States shall forward to Eurostat, on or before the date on which the first quarterly information is forwarded, a report on the methods used in compiling statistical data. Member States shall also forward to Eurostat details of any substantial changes in the methods used to collect the statistical data. 2. Member States shall provide Eurostat with information each year on sample sizes, non-response rates and, in the form of standard error or confidence intervals, the reliability of the main statistical results. 3. By 31 December 2014 and every 3 years thereafter, the Commission shall submit a report on the implementation of this Regulation to the European Parliament and to the Council. That report shall evaluate in particular the quality of the statistical data transmitted, the data collection methods as well as the administrative burdens on the Member States and on the respondents. The report shall, if appropriate, be accompanied by proposals for modifying the list of variables, taking into account the findings of related projects, in particular those on air pollution emissions caused by the carriage of goods by road. Article 8 Exercise of the delegation 1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3(4) shall be conferred on the Commission for a period of 5 years from 23 February 2012. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 3(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 3(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 9 Committee procedure 1. The Commission shall be assisted by the European Statistical System Committee established by Regulation (EC) No 223/2009. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 10 Repeal Regulation (EC) No 1172/98 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IX. Article 11 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 18 January 2012. For the European Parliament The President M. SCHULZ For the Council The President N. WAMMEN (1) Position of the European Parliament of 1 December 2011 (not yet published in the Official Journal) and decision of the Council of 12 December 2011. (2) OJ L 163, 6.6.1998, p. 1. (3) OJ L 87, 31.3.2009, p. 164. (4) OJ L 55, 28.2.2011, p. 13. ANNEXES Annex I LIST OF VARIABLES AND METHODOLOGICAL APPENDIX Annex II CLASSIFICATION OF AXLE CONFIGURATIONS Annex III CLASSIFICATION OF TYPES OF JOURNEY Annex IV CLASSIFICATION OF GOODS Annex V CLASSIFICATION OF CATEGORIES OF DANGEROUS GOODS Annex VI CLASSIFICATION OF CARGO TYPES Annex VII CODING OF PLACES OF LOADING AND UNLOADING BY COUNTRY AND REGION Annex VIII REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Annex IX CORRELATION TABLE ANNEX I Part 1 LIST OF VARIABLES A1. vehicle-related variables; A2. journey-related variables; A3. goods-related variables (in the basic transport operation). A1. VEHICLE-RELATED VARIABLES Pursuant to the definition given in Article 2, point (d), a goods road transport vehicle shall be any single road transport vehicle, or combination of road vehicles, namely road train or articulated vehicle designed to carry goods. The vehicle-related variables to be provided are the following: 1. possibility of using vehicles for combined transport (optional); 2. axle configuration according to Annex II (optional); 3. age of the road transport vehicle (lorry or road tractor) in years (from its first registration); 4. maximum permissible weight, in 100 kg; 5. load capacity, in 100 kg; 6. vehicle operator\u2019s NACE Rev. 2 at class level (four-digit level) (optional) (1); 7. type of transport (hire or reward/own account); 8. total kilometres covered during the survey period; 8.1. loaded; 8.2. empty (including road tractor journeys without semi-trailer) (optional); 9. vehicle weighting, to be used to obtain full results from individual data if the data are collected on the basis of random sampling. Successive configurations When the road transport vehicle chosen for the survey is a lorry used alone, namely without a trailer, throughout the survey period, it constitutes in itself the road vehicle for the transport of goods. However, when the road transport vehicle chosen for the survey is a road tractor \u2014 in which case it will have a semi-trailer coupled \u2014 or when it is a lorry to which a trailer is coupled, the data required under this Regulation concern the road vehicle for the transport of goods taken as a whole. In this case, there may be a change of configuration during the survey period (with a lorry acquiring a trailer or changing trailer during the period, or a road tractor changing its semi-trailer). In such a case, these successive configurations must be recorded, and the data on the vehicle must be supplied for each journey. However, if it is not possible to record these successive configurations, it is agreed that, for the vehicle-related variables, those corresponding to the configuration at the beginning of the first laden journey made during the survey period or to the configuration used most during that period will be recorded. Change in type of transport In the same way, depending on the journey, the transport may be effected on own account or for hire or reward, and the type of transport must be recorded for each journey. However, if it is not possible to record these changes, it is agreed that the \u2018type of transport\u2019 recorded will be that corresponding to the main mode of utilisation. A2. JOURNEY-RELATED VARIABLES During the survey period, the goods road transport vehicle makes journeys, either unloaded (there are no goods or empty packaging in the lorry, the trailer or the semi-trailer, which are therefore \u2018completely empty\u2019) or loaded (there are either goods or empty packaging in the lorry, the trailer or the semi-trailer, empty packaging being a particular type of goods). The loaded distance of the goods road transport vehicle is the distance between the first place of loading and the last place of unloading (where the goods road transport vehicle is completely emptied). A laden journey can therefore cover several basic transport operations. The variables to be provided for each journey are as follows: 1. type of journey in accordance with the nomenclature in Annex III; 2. weight of goods carried during the journey or during each stage of the journey, gross weight in 100 kg; 3. place of loading (of the goods road transport vehicle, for a laden journey): \u2014 definition: the place of loading is the first place in which goods are loaded on the goods road transport vehicle, which was previously completely empty (or where the road tractor is coupled up to a laden semi-trailer). For an unladen journey, it is the place of unloading of the preceding laden journey (notion of \u2018place where unladen journey begins\u2019), \u2014 coding: the place of loading is coded in accordance with Annex VII; 4. place of unloading (of the goods road transport vehicle, for a laden journey): \u2014 definition: the place of unloading is the last place in which goods are unloaded from the goods road transport vehicle, which is subsequently completely empty (or where the road tractor is uncoupled from a semi-trailer). For an unladen journey, it is the place of loading of the subsequent laden journey (notion of \u2018place where unladen journey ends\u2019), \u2014 coding: the place of unloading is coded in accordance with Annex VII; 5. distance travelled: actual distance excluding the distance covered by the goods road transport vehicle while being transported by another means of transport; 6. tonne-kilometre effected during the journey; 7. countries crossed in transit (not more than five), coded according to Annex VII; 8. place of loading, if any, of the road transport vehicle on another means of transport in accordance with Annex VII (optional); 9. place of unloading, if any, of the road transport vehicle from another means of transport in accordance with Annex VII (optional); 10. situation \u2018fully loaded\u2019 (procedure 2) or \u2018not fully loaded\u2019 (procedure 1) of the goods road transport vehicle during the journey in question, in terms of maximum volume of space used during the journey (procedure 0 = by convention for unladen journeys) (optional). A3. GOODS-RELATED VARIABLES (in the basic transport operation) During a laden journey, several basic transport operations can be carried out, a basic transport operation being defined as the transport of one type of goods (defined by reference to a particular classification level) between its place of loading and its place of unloading. The variables to be provided relating to a basic transport operation during a laden journey are as follows: 1. type of goods, according to the division level referring to an appropriate classification (see Annex IV); 2. weight of goods: gross weight in 100 kg; 3. if need be, the classification of the goods as dangerous according to the main categories of Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (2) given in Annex V to this Regulation; 4. type of freight as given in Annex VI (optional); 5. place of loading of the goods, coded in accordance with Annex VII; 6. place of unloading of the goods, coded in accordance with Annex VII; 7. distance travelled, actual distance excluding the distance covered with the goods road transport vehicle while being transported by another means of transport. Transport operations carried out during a \u2018collection or distribution round\u2019 type of journey (journey-type 3) For this type of journey, with several loading and/or unloading points, it is practically impossible to ask the transport operators to describe the basic transport operations. For these journeys, when identified as such, a single, notional, basic transport operation is generally generated on the basis of the information on the journey. Each Member State shall inform the Commission of its definition of this type of journey and explain the simplifying assumptions it is obliged to apply when collecting data on the corresponding transport operations. Part 2 METHODOLOGICAL APPENDIX Laden journeys and basic transport operations Depending on the Member State concerned, information on transport is collected on the basis of: \u2014 either a description of each basic goods transport operation (with additional details on unladen journeys), \u2014 or a description of the journeys made by the vehicle in carrying out these basic goods transport operations. In the great majority of cases, when a laden journey is made this represents one basic transport operation only with: \u2014 a single type of goods loaded (by reference to the classification of goods in use, in this case the 20 divisions derived from the NST classification) (3), \u2014 a single point of loading for the goods, \u2014 a single point of unloading for the goods. In this case the two methods used are completely equivalent, and the information collected by either method describes both: \u2014 the transport of the goods (all the basic goods transport operations), \u2014 the journeys made by the vehicles carrying out this transport, with details of vehicle capacities and utilisation of these capacities (laden journey with utilisation coefficient; unladen journey). Under this Regulation, the transport of goods and the journeys made by the vehicles must both be described, but it is undesirable to impose on the transport operators an excessive increase in the burden of statistics by asking them to describe in detail the transport of goods and the vehicle journeys. Accordingly, the NSOs in the Member States, when coding the questionnaires, must reconstitute the data which are not explicitly required from the transport operators from the data which they collect on the basis of either the \u2018basic transport operation\u2019, or the \u2018vehicle journey\u2019. The problem will arise when several basic transport operations are carried out in the course of one laden journey, which may be because: \u2014 there are several points of loading and/or unloading of the goods (but limited in number, otherwise these would be pick-up or distribution rounds, which require special treatment). In this case, these various loading and/or unloading points are recorded, in order to calculate directly the tonne-kilometre effected during the journey, and the statistical office can reconstitute the basic transport operations, and/or \u2014 there are several different types of goods transported during the laden journey, a fact which in general is not recorded in the statistics, since only the type of goods (single or main) is requested. In this case the loss of information is accepted and Member States carrying out this type of simplification will make explicit mention of it to the Commission. (1) Statistical classification of economic activities in the European Union. (2) OJ L 260, 30.9.2008, p. 13. (3) NST: Uniform nomenclature of goods for transport statistics. ANNEX II CLASSIFICATION OF AXLE CONFIGURATIONS Where a combination of vehicles is used, the axle configuration counts the total number of axles, namely the axles of the lorry or the road tractor, plus those of the trailer or semi-trailer. The axle categories considered are as follows: Coding 1. Number of axles of single vehicles (lorries): 2 120 3 130 4 140 other 199 2. Number of axles for combinations of vehicles: lorry and trailer: 2+1 221 2+2 222 2+3 223 3+2 232 3+3 233 other 299 3. Number of axles for combinations of vehicles: road tractor and semi-trailer: 2+1 321 2+2 322 2+3 323 3+2 332 3+3 333 other 399 4. Road tractor alone 499 ANNEX III CLASSIFICATION OF TYPES OF JOURNEY 1. Laden journey involving one single basic transport operation. 2. Laden journey involving several transport operations, but not considered as a collection or distribution round. 3. Laden journey of the collection or distribution round type. 4. Unladen journeys. ANNEX IV CLASSIFICATION OF GOODS Division Description 01 Products of agriculture, hunting, and forestry; fish and other fishing products 02 Coal and lignite; crude petroleum and natural gas 03 Metal ores and other mining and quarrying products; peat; uranium and thorium 04 Food products, beverages and tobacco 05 Textiles and textile products; leather and leather products 06 Wood and products of wood and cork (except furniture); articles of straw and plaiting materials; pulp, paper and paper products; printed matter and recorded media 07 Coke and refined petroleum products 08 Chemicals, chemical products, and man-made fibres; rubber and plastic products; nuclear fuel 09 Other non-metallic mineral products 10 Basic metals; fabricated metal products, except machinery and equipment 11 Machinery and equipment n.e.c.; office machinery and computers; electrical machinery and apparatus n.e.c.; radio, television and communication equipment and apparatus; medical, precision and optical instruments; watches and clocks 12 Transport equipment 13 Furniture; other manufactured goods n.e.c. 14 Secondary raw materials; municipal wastes and other wastes 15 Mail, parcels 16 Equipment and material utilised in the transport of goods 17 Goods moved in the course of household and office removals; baggage transported separately from passengers; motor vehicles being moved for repair; other non-market goods n.e.c. 18 Grouped goods: a mixture of types of goods which are transported together 19 Unidentifiable goods: goods which for any reason cannot be identified and therefore cannot be assigned to groups 1-16 20 Other goods n.e.c. ANNEX V CLASSIFICATION OF CATEGORIES OF DANGEROUS GOODS 1 Explosives 2 Gases, compressed, liquefied or dissolved under pressure 3 Flammable liquids 4.1 Flammable solids 4.2 Substances liable to spontaneous combustion 4.3 Substances which, in contact with water, emit flammable gases 5.1 Oxidising substances 5.2 Organic peroxides 6.1 Toxic substances 6.2 Substances liable to cause infections 7 Radioactive material 8 Corrosives 9 Miscellaneous dangerous substances ANNEX VI CLASSIFICATION OF CARGO TYPES (1) 0 Liquid bulk goods (no cargo unit) 1 Solid bulk goods (no cargo unit) 2 Large freight containers 3 Other freight containers 4 Palletised goods 5 Pre-slung goods 6 Mobile, self-propelled units 7 Other mobile units 8 (Reserved) 9 Other cargo types (1) United Nations, Economic Commission for Europe \u2014 Codes for types of cargo, packages and packaging materials, Recommendation 21 adopted by the Working Party on Facilitation of International Trade Procedures, Geneva, March 1986. ANNEX VII CODING OF PLACES OF LOADING AND UNLOADING BY COUNTRY AND REGION 1. The places of loading and unloading will be coded as follows: (a) regional breakdown to Level 3 of the Nomenclature of Territorial Units for Statistics (NUTS), for the Member States; (b) lists of administrative regions supplied by the third country concerned, for States which are not Members but which are contracting parties to the Agreement on the European Economic Area (EEA), namely Iceland, Liechtenstein and Norway; (c) the 2-alpha ISO 3166 codes, for other third countries. The most frequently-used codes are given in the table in point 2(b) of this Annex. 2. For the coding of countries crossed in transit (Section 7 of Annex I, Part A2), the following country codes are to be used: (a) the 2-alpha part of the NUTS codes, as given in the table below, for the Member States; (b) the 2-alpha ISO 3166 codes, for all other countries. The most frequently-used codes are given in the table below. TABLE OF COUNTRY CODES (a) Member States (corresponding to NUTS 2-alpha country codes) Country name Code Belgium BE Bulgaria BG Czech Republic CZ Denmark DK Germany DE Estonia EE Ireland IE Greece EL Spain ES France FR Italy IT Cyprus CY Latvia LV Lithuania LT Luxembourg LU Hungary HU Malta MT Netherlands NL Austria AT Poland PL Portugal PT Romania RO Slovenia SI Slovakia SK Finland FI Sweden SE United Kingdom UK Note: countries in official European Union order. (b) Other countries (ISO 3166 2-alpha codes) Country name Code Albania AL Bosnia and Herzegovina BA Belarus BY Switzerland CH Croatia HR Iceland IS Liechtenstein LI Moldova MD Montenegro ME former Yugoslav Republic of Macedonia, the MK (1) Norway NO Serbia RS Russia RU Turkey TR Ukraine UA Note: countries ordered by code. (1) Provisional code, which does not prejudge in any way the definitive nomenclature for this country, which will be agreed following the conclusion of negotiations currently taking place on this subject at the United Nations. ANNEX VIII REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Council Regulation (EC) No 1172/98 (OJ L 163, 6.6.1998, p. 1) Commission Regulation (EC) No 2691/1999 (OJ L 326, 18.12.1999, p. 39) Point 10.15 of Annex II to the 2003 Act of Accession (OJ L 236, 23.9.2003, p. 561) Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) Only Annex II, point 27 Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1) Only point 8.5 of the Annex Regulation (EC) No 1893/2006 of the European Parliament and of the Council (OJ L 393, 30.12.2006, p. 1) Only Article 13 Commission Regulation (EC) No 1304/2007 (OJ L 290, 8.11.2007, p. 14) Only Article 2 Regulation (EC) No 399/2009 of the European Parliament and of the Council (OJ L 126, 21.5.2009, p. 9) ANNEX IX CORRELATION TABLE Regulation (EC) No 1172/98 This Regulation Article 1 Article 1 Article 2, first to fourteenth indents Article 2, points (a) to (n) Article 3 Article 3 Article 4 Article 4 Article 5(1), (2) and (3) Article 5(1), (2) and (3) Article 5(4) \u2014 Article 5(5) \u2014 Article 6 Article 6 Article 7(1) and (2) Article 7(1) and (2) Article 7(3) \u2014 Article 8 \u2014 \u2014 Article 8 Article 10(1) and (2) Article 9(1) and (2) Article 10(3) \u2014 Article 11 \u2014 \u2014 Article 10 Article 12 Article 11 Annexes A to G Annexes I to VII \u2014 Annex VIII \u2014 Annex IX", "summary": "Rules for the compilation of statistics regarding goods carried by road Rules for the compilation of statistics regarding goods carried by road SUMMARY OF: Regulation (EU) No 70/2012 \u2014 road freight statistics WHAT IS THE AIM OF THIS REGULATION? It sets out the rules for the production of comparable EU-wide statistics on goods transport by road. It revises and repeals Regulation (EC) No 1172/98, which had been amended several times, and aligns the regulation with the Lisbon treaty with regard to the delegation of powers to the European Commission to adopt supplementary legislation. KEY POINTS Scope EU countries must each compile and transmit to the Commission (Eurostat) data relating to freight transported by means of road transport vehicles registered on their territory. The regulation does not apply to freight transported by: goods road transport vehicles whose authorised weight or dimensions exceed the limits normally permitted in the EU countries concerned; agricultural vehicles, military vehicles and vehicles belonging to central or local public administrations, with the exception of goods road transport vehicles belonging to public companies , and in particular railway companies. EU countries may exclude goods road transport vehicles whose load capacity or maximum permissible weight is lower than a certain limit. That limit may not exceed a load capacity of 3.5 tonnes or a maximum permissible weight of 6 tonnes in the case of single motor vehicles. The regulation does not apply to Malta so long as the number of Maltese-registered goods road transport vehicles licensed to engage in the international carriage of freight by road does not exceed 400 vehicles. Data collection and transmission Every quarter, by means of sample surveys, EU countries must compile and transmit data to Eurostat relating to 3 areas: vehicles (see the regulation\u2019s Annexes I and II); journeys (see the regulation\u2019s Annex III); goods (see the regulation\u2019s Annexes IV and V). EU countries must transmit data within 5 months of the end of the quarter under observation. Dissemination of results Eurostat disseminates the data no later than 12 months after the end of the period to which they relate. Reports When they forward the data for the first quarter, EU countries send a report to Eurostat on the methods used to compile data. They must also inform Eurostat if they make any substantial changes to these methods. Every year, they must provide Eurostat with information on sample sizes, non-response rates and, in the form of standard error or confidence intervals, the reliability of the main statistical results. The Commission (Eurostat) must report for the first time by December 2014, and thereafter every 3 years, to the European Parliament and the Council on the regulation\u2019s implementation. Committee The Commission is advised and assisted by the European Statistical System Committee established by Regulation (EC) No 223/2009. Powers delegated to the Commission The Commission has not yet exercised the power to adopt delegated acts that the regulation granted to it. In a report, published in 2016, the Commission explained that neither economic and technical developments in the field of road freight transport nor conclusions of the Commission\u2019s Working Groups on road freight statistics involving experts from EU countries raised the need to use these delegated powers. FROM WHEN DOES THE REGULATION APPLY? It has applied since 23 February 2012. BACKGROUND For more information, see: Road freight transport statistics (Eurostat). MAIN DOCUMENT Regulation (EU) No 70/2012 of the European Parliament and of the Council of 18 January 2012 on statistical returns in respect of the carriage of goods by road (OJ L 32, 3.2.2012, pp. 1-18) Successive amendments to Regulation (EU) No 70/2012 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Report from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission under Regulation (EU) No 70/2012 of 18 January 2012 on statistical returns in respect of the carriage of goods by road (COM(2016) 562 final, 12.9.2016) Report from the Commission to the European Parliament and the Council on the implementation of Regulation (EU) No 70/2012 of the European Parliament and of the Council of 18 January 2012 on statistical returns in respect of the carriage of goods by road (COM(2015) 17 final, 26.1.2015) last update 07.11.2017"}
{"article": "10.12.2007 EN Official Journal of the European Union L 324/79 REGULATION (EC) No 1393/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents), and repealing Council Regulation (EC) No 1348/2000 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 61(c) and Article 67(5), second indent, thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The Union has set itself the objective of maintaining and developing the Union as an area of freedom, security and justice, in which the free movement of persons is assured. To establish such an area, the Community is to adopt, among others, the measures relating to judicial cooperation in civil matters needed for the proper functioning of the internal market. (2) The proper functioning of the internal market entails the need to improve and expedite the transmission of judicial and extrajudicial documents in civil or commercial matters for service between the Member States. (3) The Council, by an Act dated 26 May 1997 (3), drew up a Convention on the service in the Member States of the European Union of judicial and extrajudicial documents in civil or commercial matters and recommended it for adoption by the Member States in accordance with their respective constitutional rules. That Convention has not entered into force. Continuity in the results of the negotiations for conclusion of the Convention should be ensured. (4) On 29 May 2000 the Council adopted Regulation (EC) No 1348/2000 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (4). The main content of that Regulation is based on the Convention. (5) On 1 October 2004 the Commission adopted a report on the application of Regulation (EC) No 1348/2000. The report concludes that the application of Regulation (EC) No 1348/2000 has generally improved and expedited the transmission and the service of documents between Member States since its entry into force in 2001, but that nevertheless the application of certain provisions is not fully satisfactory. (6) Efficiency and speed in judicial procedures in civil matters require that judicial and extrajudicial documents be transmitted directly and by rapid means between local bodies designated by the Member States. Member States may indicate their intention to designate only one transmitting or receiving agency or one agency to perform both functions, for a period of five years. This designation may, however, be renewed every five years. (7) Speed in transmission warrants the use of all appropriate means, provided that certain conditions as to the legibility and reliability of the document received are observed. Security in transmission requires that the document to be transmitted be accompanied by a standard form, to be completed in the official language or one of the official languages of the place where service is to be effected, or in another language accepted by the Member State in question. (8) This Regulation should not apply to service of a document on the party\u2019s authorised representative in the Member State where the proceedings are taking place regardless of the place of residence of that party. (9) The service of a document should be effected as soon as possible, and in any event within one month of receipt by the receiving agency. (10) To secure the effectiveness of this Regulation, the possibility of refusing service of documents should be confined to exceptional situations. (11) In order to facilitate the transmission and service of documents between Member States, the standard forms set out in the Annexes to this Regulation should be used. (12) The receiving agency should inform the addressee in writing using the standard form that he may refuse to accept the document to be served at the time of service or by returning the document to the receiving agency within one week if it is not either in a language which he understands or in the official language or one of the official languages of the place of service. This rule should also apply to the subsequent service once the addressee has exercised his right of refusal. These rules on refusal should also apply to service by diplomatic or consular agents, service by postal services and direct service. It should be established that the service of the refused document can be remedied through the service on the addressee of a translation of the document. (13) Speed in transmission warrants documents being served within days of receipt of the document. However, if service has not been effected after one month has elapsed, the receiving agency should inform the transmitting agency. The expiry of this period should not imply that the request be returned to the transmitting agency where it is clear that service is feasible within a reasonable period. (14) The receiving agency should continue to take all necessary steps to effect the service of the document also in cases where it has not been possible to effect service within the month, for example, because the defendant has been away from his home on holiday or away from his office on business. However, in order to avoid an open-ended obligation for the receiving agency to take steps to effect the service of a document, the transmitting agency should be able to specify a time limit in the standard form after which service is no longer required. (15) Given the differences between the Member States as regards their rules of procedure, the material date for the purposes of service varies from one Member State to another. Having regard to such situations and the possible difficulties that may arise, this Regulation should provide for a system where it is the law of the Member State addressed which determines the date of service. However, where according to the law of a Member State a document has to be served within a particular period, the date to be taken into account with respect to the applicant should be that determined by the law of that Member State. This double date system exists only in a limited number of Member States. Those Member States which apply this system should communicate this to the Commission, which should publish the information in the Official Journal of the European Union and make it available through the European Judicial Network in Civil and Commercial Matters established by Council Decision 2001/470/EC (5). (16) In order to facilitate access to justice, costs occasioned by recourse to a judicial officer or a person competent under the law of the Member State addressed should correspond to a single fixed fee laid down by that Member State in advance which respects the principles of proportionality and non-discrimination. The requirement of a single fixed fee should not preclude the possibility for Member States to set different fees for different types of service as long as they respect these principles. (17) Each Member State should be free to effect service of documents directly by postal services on persons residing in another Member State by registered letter with acknowledgement of receipt or equivalent. (18) It should be possible for any person interested in a judicial proceeding to effect service of documents directly through the judicial officers, officials or other competent persons of the Member State addressed, where such direct service is permitted under the law of that Member State. (19) The Commission should draw up a manual containing information relevant for the proper application of this Regulation, which should be made available through the European Judicial Network in Civil and Commercial Matters. The Commission and the Member States should do their utmost to ensure that this information is up to date and complete especially as regards contact details of receiving and transmitting agencies. (20) In calculating the periods and time limits provided for in this Regulation, Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits (6) should apply. (21) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7). (22) In particular, power should be conferred on the Commission to update or make technical amendments to the standard forms set out in the Annexes. Since those measures are of general scope and are designed to amend/delete non-essential elements of this Regulation, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (23) This Regulation prevails over the provisions contained in bilateral or multilateral agreements or arrangements having the same scope, concluded by the Member States, and in particular the Protocol annexed to the Brussels Convention of 27 September 1968 (8) and the Hague Convention of 15 November 1965 (9) in relations between the Member States party thereto. This Regulation does not preclude Member States from maintaining or concluding agreements or arrangements to expedite or simplify the transmission of documents, provided that they are compatible with this Regulation. (24) The information transmitted pursuant to this Regulation should enjoy suitable protection. This matter falls within the scope of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (10), and of Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (11). (25) No later than 1 June 2011 and every five years thereafter, the Commission should review the application of this Regulation and propose such amendments as may appear necessary. (26) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (27) In order to make the provisions more easily accessible and readable, Regulation (EC) No 1348/2000 should be repealed and replaced by this Regulation. (28) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom and Ireland are taking part in the adoption and application of this Regulation. (29) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark does not take part in the adoption of this Regulation and is not bound by it or subject to its application, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Scope 1. This Regulation shall apply in civil and commercial matters where a judicial or extrajudicial document has to be transmitted from one Member State to another for service there. It shall not extend in particular to revenue, customs or administrative matters or to liability of the State for actions or omissions in the exercise of state authority (acta iure imperii). 2. This Regulation shall not apply where the address of the person to be served with the document is not known. 3. In this Regulation, the term \u2018Member State\u2019 shall mean the Member States with the exception of Denmark. Article 2 Transmitting and receiving agencies 1. Each Member State shall designate the public officers, authorities or other persons, hereinafter referred to as \u2018transmitting agencies\u2019, competent for the transmission of judicial or extrajudicial documents to be served in another Member State. 2. Each Member State shall designate the public officers, authorities or other persons, hereinafter referred to as \u2018receiving agencies\u2019, competent for the receipt of judicial or extrajudicial documents from another Member State. 3. A Member State may designate one transmitting agency and one receiving agency, or one agency to perform both functions. A federal State, a State in which several legal systems apply or a State with autonomous territorial units shall be free to designate more than one such agency. The designation shall have effect for a period of five years and may be renewed at five-year intervals. 4. Each Member State shall provide the Commission with the following information: (a) the names and addresses of the receiving agencies referred to in paragraphs 2 and 3; (b) the geographical areas in which they have jurisdiction; (c) the means of receipt of documents available to them; and (d) the languages that may be used for the completion of the standard form set out in Annex I. Member States shall notify the Commission of any subsequent modification of such information. Article 3 Central body Each Member State shall designate a central body responsible for: (a) supplying information to the transmitting agencies; (b) seeking solutions to any difficulties which may arise during transmission of documents for service; (c) forwarding, in exceptional cases, at the request of a transmitting agency, a request for service to the competent receiving agency. A federal State, a State in which several legal systems apply or a State with autonomous territorial units shall be free to designate more than one central body. CHAPTER II JUDICIAL DOCUMENTS Section 1 Transmission and service of judicial documents Article 4 Transmission of documents 1. Judicial documents shall be transmitted directly and as soon as possible between the agencies designated pursuant to Article 2. 2. The transmission of documents, requests, confirmations, receipts, certificates and any other papers between transmitting agencies and receiving agencies may be carried out by any appropriate means, provided that the content of the document received is true and faithful to that of the document forwarded and that all information in it is easily legible. 3. The document to be transmitted shall be accompanied by a request drawn up using the standard form set out in Annex I. The form shall be completed in the official language of the Member State addressed or, if there are several official languages in that Member State, the official language or one of the official languages of the place where service is to be effected, or in another language which that Member State has indicated it can accept. Each Member State shall indicate the official language or languages of the institutions of the European Union other than its own which is or are acceptable to it for completion of the form. 4. The documents and all papers that are transmitted shall be exempted from legalisation or any equivalent formality. 5. When the transmitting agency wishes a copy of the document to be returned together with the certificate referred to in Article 10, it shall send the document in duplicate. Article 5 Translation of documents 1. The applicant shall be advised by the transmitting agency to which he forwards the document for transmission that the addressee may refuse to accept it if it is not in one of the languages provided for in Article 8. 2. The applicant shall bear any costs of translation prior to the transmission of the document, without prejudice to any possible subsequent decision by the court or competent authority on liability for such costs. Article 6 Receipt of documents by receiving agency 1. On receipt of a document, a receiving agency shall, as soon as possible and in any event within seven days of receipt, send a receipt to the transmitting agency by the swiftest possible means of transmission using the standard form set out in Annex I. 2. Where the request for service cannot be fulfilled on the basis of the information or documents transmitted, the receiving agency shall contact the transmitting agency by the swiftest possible means in order to secure the missing information or documents. 3. If the request for service is manifestly outside the scope of this Regulation or if non-compliance with the formal conditions required makes service impossible, the request and the documents transmitted shall be returned, on receipt, to the transmitting agency, together with the notice of return using the standard form set out in Annex I. 4. A receiving agency receiving a document for service but not having territorial jurisdiction to serve it shall forward it, as well as the request, to the receiving agency having territorial jurisdiction in the same Member State if the request complies with the conditions laid down in Article 4(3) and shall inform the transmitting agency accordingly using the standard form set out in Annex I. That receiving agency shall inform the transmitting agency when it receives the document, in the manner provided for in paragraph 1. Article 7 Service of documents 1. The receiving agency shall itself serve the document or have it served, either in accordance with the law of the Member State addressed or by a particular method requested by the transmitting agency, unless that method is incompatible with the law of that Member State. 2. The receiving agency shall take all necessary steps to effect the service of the document as soon as possible, and in any event within one month of receipt. If it has not been possible to effect service within one month of receipt, the receiving agency shall: (a) immediately inform the transmitting agency by means of the certificate in the standard form set out in Annex I, which shall be drawn up under the conditions referred to in Article 10(2); and (b) continue to take all necessary steps to effect the service of the document, unless indicated otherwise by the transmitting agency, where service seems to be possible within a reasonable period of time. Article 8 Refusal to accept a document 1. The receiving agency shall inform the addressee, using the standard form set out in Annex II, that he may refuse to accept the document to be served at the time of service or by returning the document to the receiving agency within one week if it is not written in, or accompanied by a translation into, either of the following languages: (a) a language which the addressee understands; or (b) the official language of the Member State addressed or, if there are several official languages in that Member State, the official language or one of the official languages of the place where service is to be effected. 2. Where the receiving agency is informed that the addressee refuses to accept the document in accordance with paragraph 1, it shall immediately inform the transmitting agency by means of the certificate provided for in Article 10 and return the request and the documents of which a translation is requested. 3. If the addressee has refused to accept the document pursuant to paragraph 1, the service of the document can be remedied through the service on the addressee in accordance with the provisions of this Regulation of the document accompanied by a translation into a language provided for in paragraph 1. In that case, the date of service of the document shall be the date on which the document accompanied by the translation is served in accordance with the law of the Member State addressed. However, where according to the law of a Member State, a document has to be served within a particular period, the date to be taken into account with respect to the applicant shall be the date of the service of the initial document determined pursuant to Article 9(2). 4. Paragraphs 1, 2 and 3 shall also apply to the means of transmission and service of judicial documents provided for in Section 2. 5. For the purposes of paragraph 1, the diplomatic or consular agents, where service is effected in accordance with Article 13, or the authority or person, where service is effected in accordance with Article 14, shall inform the addressee that he may refuse to accept the document and that any document refused must be sent to those agents or to that authority or person respectively. Article 9 Date of service 1. Without prejudice to Article 8, the date of service of a document pursuant to Article 7 shall be the date on which it is served in accordance with the law of the Member State addressed. 2. However, where according to the law of a Member State a document has to be served within a particular period, the date to be taken into account with respect to the applicant shall be that determined by the law of that Member State. 3. Paragraphs 1 and 2 shall also apply to the means of transmission and service of judicial documents provided for in Section 2. Article 10 Certificate of service and copy of the document served 1. When the formalities concerning the service of the document have been completed, a certificate of completion of those formalities shall be drawn up in the standard form set out in Annex I and addressed to the transmitting agency, together with, where Article 4(5) applies, a copy of the document served. 2. The certificate shall be completed in the official language or one of the official languages of the Member State of origin or in another language which the Member State of origin has indicated that it can accept. Each Member State shall indicate the official language or languages of the institutions of the European Union other than its own which is or are acceptable to it for completion of the form. Article 11 Costs of service 1. The service of judicial documents coming from a Member State shall not give rise to any payment or reimbursement of taxes or costs for services rendered by the Member State addressed. 2. However, the applicant shall pay or reimburse the costs occasioned by: (a) recourse to a judicial officer or to a person competent under the law of the Member State addressed; (b) the use of a particular method of service. Costs occasioned by recourse to a judicial officer or to a person competent under the law of the Member State addressed shall correspond to a single fixed fee laid down by that Member State in advance which respects the principles of proportionality and non-discrimination. Member States shall communicate such fixed fees to the Commission. Section 2 Other means of transmission and service of judicial documents Article 12 Transmission by consular or diplomatic channels Each Member State shall be free, in exceptional circumstances, to use consular or diplomatic channels to forward judicial documents, for the purpose of service, to those agencies of another Member State which are designated pursuant to Articles 2 or 3. Article 13 Service by diplomatic or consular agents 1. Each Member State shall be free to effect service of judicial documents on persons residing in another Member State, without application of any compulsion, directly through its diplomatic or consular agents. 2. Any Member State may make it known, in accordance with Article 23(1), that it is opposed to such service within its territory, unless the documents are to be served on nationals of the Member State in which the documents originate. Article 14 Service by postal services Each Member State shall be free to effect service of judicial documents directly by postal services on persons residing in another Member State by registered letter with acknowledgement of receipt or equivalent. Article 15 Direct service Any person interested in a judicial proceeding may effect service of judicial documents directly through the judicial officers, officials or other competent persons of the Member State addressed, where such direct service is permitted under the law of that Member State. CHAPTER III EXTRAJUDICIAL DOCUMENTS Article 16 Transmission Extrajudicial documents may be transmitted for service in another Member State in accordance with the provisions of this Regulation. CHAPTER IV FINAL PROVISIONS Article 17 Implementing rules Measures designed to amend non-essential elements of this Regulation relating to the updating or to the making of technical amendments to the standard forms set out in Annexes I and II shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2). Article 18 Committee 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 19 Defendant not entering an appearance 1. Where a writ of summons or an equivalent document has had to be transmitted to another Member State for the purpose of service under the provisions of this Regulation and the defendant has not appeared, judgment shall not be given until it is established that: (a) the document was served by a method prescribed by the internal law of the Member State addressed for the service of documents in domestic actions upon persons who are within its territory; or (b) the document was actually delivered to the defendant or to his residence by another method provided for by this Regulation; and that in either of these cases the service or the delivery was effected in sufficient time to enable the defendant to defend. 2. Each Member State may make it known, in accordance with Article 23(1), that the judge, notwithstanding the provisions of paragraph 1, may give judgment even if no certificate of service or delivery has been received, if all the following conditions are fulfilled: (a) the document was transmitted by one of the methods provided for in this Regulation; (b) a period of time of not less than six months, considered adequate by the judge in the particular case, has elapsed since the date of the transmission of the document; (c) no certificate of any kind has been received, even though every reasonable effort has been made to obtain it through the competent authorities or bodies of the Member State addressed. 3. Notwithstanding paragraphs 1 and 2, the judge may order, in case of urgency, any provisional or protective measures. 4. When a writ of summons or an equivalent document has had to be transmitted to another Member State for the purpose of service under the provisions of this Regulation and a judgment has been entered against a defendant who has not appeared, the judge shall have the power to relieve the defendant from the effects of the expiry of the time for appeal from the judgment if the following conditions are fulfilled: (a) the defendant, without any fault on his part, did not have knowledge of the document in sufficient time to defend, or knowledge of the judgment in sufficient time to appeal; and (b) the defendant has disclosed a prima facie defence to the action on the merits. An application for relief may be filed only within a reasonable time after the defendant has knowledge of the judgment. Each Member State may make it known, in accordance with Article 23(1), that such application will not be entertained if it is filed after the expiry of a time to be stated by it in that communication, but which shall in no case be less than one year following the date of the judgment. 5. Paragraph 4 shall not apply to judgments concerning the status or capacity of persons. Article 20 Relationship with agreements or arrangements to which Member States are party 1. This Regulation shall, in relation to matters to which it applies, prevail over other provisions contained in bilateral or multilateral agreements or arrangements concluded by the Member States, and in particular Article IV of the Protocol to the Brussels Convention of 1968 and the Hague Convention of 15 November 1965. 2. This Regulation shall not preclude individual Member States from maintaining or concluding agreements or arrangements to expedite further or simplify the transmission of documents, provided that they are compatible with this Regulation. 3. Member States shall send to the Commission: (a) a copy of the agreements or arrangements referred to in paragraph 2 concluded between the Member States as well as drafts of such agreements or arrangements which they intend to adopt; and (b) any denunciation of, or amendments to, these agreements or arrangements. Article 21 Legal aid This Regulation shall not affect the application of Article 23 of the Convention on civil procedure of 17 July 1905, Article 24 of the Convention on civil procedure of 1 March 1954 or Article 13 of the Convention on international access to justice of 25 October 1980 between the Member States party to those Conventions. Article 22 Protection of information transmitted 1. Information, including in particular personal data, transmitted under this Regulation shall be used by the receiving agency only for the purpose for which it was transmitted. 2. Receiving agencies shall ensure the confidentiality of such information, in accordance with their national law. 3. Paragraphs 1 and 2 shall not affect national laws enabling data subjects to be informed of the use made of information transmitted under this Regulation. 4. This Regulation shall be without prejudice to Directives 95/46/EC and 2002/58/EC. Article 23 Communication and publication 1. Member States shall communicate to the Commission the information referred to in Articles 2, 3, 4, 10, 11, 13, 15 and 19. Member States shall communicate to the Commission if, according to their law, a document has to be served within a particular period as referred to in Articles 8(3) and 9(2). 2. The Commission shall publish the information communicated in accordance with paragraph 1 in the Official Journal of the European Union with the exception of the addresses and other contact details of the agencies and of the central bodies and the geographical areas in which they have jurisdiction. 3. The Commission shall draw up and update regularly a manual containing the information referred to in paragraph 1, which shall be available electronically, in particular through the European Judicial Network in Civil and Commercial Matters. Article 24 Review No later than 1 June 2011, and every five years thereafter, the Commission shall present to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Regulation, paying special attention to the effectiveness of the agencies designated pursuant to Article 2 and to the practical application of Article 3(c) and Article 9. The report shall be accompanied if need be by proposals for adaptations of this Regulation in line with the evolution of notification systems. Article 25 Repeal 1. Regulation (EC) No 1348/2000 shall be repealed as from the date of application of this Regulation. 2. References made to the repealed Regulation shall be construed as being made to this Regulation and should be read in accordance with the correlation table in Annex III. Article 26 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 13 November 2008 with the exception of Article 23 which shall apply from 13 August 2008. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaty establishing the European Community. Done at Strasbourg, 13 November 2007. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President M. LOBO ANTUNES (1) OJ C 88, 11.4.2006, p. 7. (2) Opinion of the European Parliament of 4 July 2006 (OJ C 303 E, 13.12.2006, p. 69), Council Common Position of 28 June 2007 (OJ C 193 E, 21.8.2007, p. 13) and Position of the European Parliament of 24 October 2007. (3) OJ C 261, 27.8.1997, p. 1. On the same day as the Convention was drawn up the Council took note of the explanatory report on the Convention which is set out on page 26 of the aforementioned Official Journal. (4) OJ L 160, 30.6.2000, p. 37. (5) OJ L 174, 27.6.2001, p. 25. (6) OJ L 124, 8.6.1971, p. 1. (7) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (8) Brussels Convention of 27 September 1968 on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (OJ L 299, 31.12.1972, p. 32; consolidated version, OJ C 27, 26.1.1998, p. 1). (9) Hague Convention of 15 November 1965 on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters. (10) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). (11) OJ L 201, 31.7.2002, p. 37. Directive as amended by Directive 2006/24/EC (OJ L 105, 13.4.2006, p. 54). ANNEX I ANNEX II ANNEX III CORRELATION TABLE Regulation (EC) No 1348/2000 This Regulation Article 1(1) Article 1(1) first sentence \u2014 Article 1(1) second sentence Article 1(2) Article 1(2) \u2014 Article 1(3) Article 2 Article 2 Article 3 Article 3 Article 4 Article 4 Article 5 Article 5 Article 6 Article 6 Article 7(1) Article 7(1) Article 7(2) first sentence Article 7(2) first sentence Article 7(2) second sentence Article 7(2) second sentence (introductory phrase) and Article 7(2)(a) \u2014 Article 7(2)(b) Article 7(2) third sentence \u2014 Article 8(1) introductory phrase Article 8(1) introductory phrase Article 8(1)(a) Article 8(1)(b) Article 8(1)(b) Article 8(1)(a) Article 8(2) Article 8(2) \u2014 Article 8(3) to (5) Article 9(1) and (2) Article 9(1) and (2) Article 9(3) \u2014 \u2014 Article 9(3) Article 10 Article 10 Article 11(1) Article 11(1) Article 11(2) Article 11(2) first subparagraph \u2014 Article 11(2) second subparagraph Article 12 Article 12 Article 13 Article 13 Article 14(1) Article 14 Article 14(2) \u2014 Article 15(1) Article 15 Article 15(2) \u2014 Article 16 Article 16 Article 17, introductory phrase Article 17 Article 17(a) to (c) \u2014 Article 18(1) and (2) Article 18(1) and (2) Article 18(3) \u2014 Article 19 Article 19 Article 20 Article 20 Article 21 Article 21 Article 22 Article 22 Article 23(1) Article 23(1) first sentence \u2014 Article 23(1) second sentence Article 23(2) Article 23(2) \u2014 Article 23(3) Article 24 Article 24 Article 25 \u2014 \u2014 Article 25 \u2014 Article 26 Annex Annex I \u2014 Annex II \u2014 Annex III", "summary": "Transmission of judicial and extrajudicial documents between EU countries (until 2022) Transmission of judicial and extrajudicial documents between EU countries (until 2022) SUMMARY OF: Regulation (EC) No 1393/2007 on the service in EU countries of judicial and extrajudicial documents in civil or commercial matters WHAT IS THE AIM OF THIS REGULATION? It aims to put in place a fast, secure and standardised transmission procedure for judicial* and extrajudicial documents* in civil or commercial matters between parties located in different European Union (EU) countries. Regulation (EC) No 1393/2007 is repealed and replaced by Regulation (EU) 2020/1784 (see summary) as of 1 July 2022. KEY POINTS Scope This regulation applies to civil or commercial matters where it is necessary to transmit judicial or extrajudicial documents for transmission from one EU country to another. It does not apply to: revenue,customs,administrative affairs orcases of state liability for actions or omissions in the exercise of state authority. The regulation does not apply where the address of the person to be served is unknown. Further improving the service (transmission) of judicial and extrajudicial documents The regulation introduces: a rule stipulating that the receiving agency has to take all necessary steps to transmit the document as soon as possible, and in any event within 1 month of receipt; a standard form to inform the addressee of their right to refuse to accept the document to be served \u2014 at the time that it has been served \u2014 or by returning the document to the receiving agency within a week; a rule stipulating that costs which arise from recourse to a judicial officer or to a person competent under the law of the EU country addressed must correspond to a single fixed fee laid down by that country in advance, respecting the principles of proportionality and non-discrimination; uniform conditions for service by postal services (registered letter with acknowledgement of receipt or equivalent). Agencies within EU countries ensure transmission EU countries designate the agencies that are responsible for transmitting and receiving documents. They must provide the European Commission with their names and addresses, the geographical areas to which they apply, and their accepted languages and means of receipt of documents. Each EU country also has a central body that is responsible for supplying information to the agencies, resolving any difficulties that may arise and forwarding requests for service by the transmitting agency to the relevant receiving agency in exceptional circumstances. A federal state, one where there are several legal systems or which has autonomous territorial units, may name more than one such agency or central body. The designation is valid 5 years and maybe be renewed at 5-year intervals. Speeding up the serving of judicial and extrajudicial documents The applicant forwards documents to the transmitting agency and bears any costs of translation prior to transmitting the document. The transmitting agency is required to advise the applicant that, in the event that the document is not in a language which the addressee understands or in the official language of the EU country where service is to be effected, the latter can refuse to accept the document. Documents must be transmitted directly and as soon as possible between the agencies by any appropriate means of transmission, as long as they are legible and faithful to the original. A request using the standard form as annexed to the regulation must be attached in one of the accepted languages that the EU countries indicate. The documents are exempt from legalisation or any equivalent formality. A receipt must be sent within 7 days by the receiving agency. The latter has to contact the transmitting agency as soon as possible in case of missing information. Serving documents according to the law of the receiving EU country within 1 month The receiving agency should either serve the document itself or have it served within 1 month. If this is not possible, the receiving agency must inform the transmitting agency and continue to try to serve the document. Serving is done according to the law of the receiving EU country, or by a particular method, if this is requested by the transmitting agency and it conforms to the national law. When service has been carried out, a certificate of completion of the formalities involved must be completed in a language accepted by the EU country of origin and sent to the transmitting agency. The date of service will be the date on which the document is served, according to the law of the EU country addressed, except where it must be addressed within a particular period according to the law of that country. The service must not incur costs or taxes in the EU country addressed, except if there has been a particular method of service or recourse to a judicial officer there. In that case, it is up to the applicant to bear the costs. EU countries have to fix a single fee in advance, and communicate it to the Commission. Documents may also be served directly by using registered post with a receipt or via the judicial officers, officials or other competent persons of the EU country addressed, if this is permitted by the country in question. In exceptional circumstances, documents may be forwarded to agencies of another EU country via consular or diplomatic channels. Informing the addressee about the right to refuse the document to be served The receiving agency informs the addressee of their right to refuse the document, if it is not written in a language that he or she understands or in the official language of the EU country where service takes place. The refusal must take place at the time of service or by returning the document to the receiving agency within a week. If the document is a writ of summons (an official order for someone to appear in a court of law) or equivalent and the defendant does not appear, a judgment may not be pronounced until it is sure that the document was served according to the EU country\u2019s domestic law, it was delivered and the defendant had sufficient time to submit a defence. However, judgment may be delivered if the document was transmitted by one of the methods laid down in the regulation, and if more than 6 months have elapsed and no certificate of any kind has been obtained in spite of every reasonable effort by the competent authorities of the EU country addressed. If the defendant did not know about the document in time to appear, it is still possible to apply for relief within a reasonable time after finding out about the judgment. The Commission should provide and regularly update a manual containing the information provided by the EU countries. By 2011, and every 5 years subsequently, it must present a report on the regulation\u2019s application, focusing on the agencies\u2019 effectiveness. Repeal Regulation (EC) No 1393/2007 is repealed and replaced by Regulation (EU) 2020/1784 as of 1 July 2022. FROM WHEN DOES THE REGULATION APPLY? It has applied since 13 November 2008, except for Article 23 (on EU countries\u2019 communication and publication of certain information) which has applied since 13 August 2008. BACKGROUND For more information, see: Service of documents (European Commission). KEY TERMS Judicial document: a legal document issued in the course of a civil or commercial lawsuit (for example a summons, a writ or a judgment) that must be served on a party. Extrajudicial document: a legal document that is served but is outside the case file (for example, an invoice or an eviction notice). MAIN DOCUMENT Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents), and repealing Council Regulation (EC) No 1348/2000 (OJ L 324, 10.12.2007, pp. 79-120) Successive amendments to Council Regulation (EC) No 1393/2007 have been incorporated into the original text. This consolidated version is of documentary value only. last update 11.12.2020"}
{"article": "10.12.2007 EN Official Journal of the European Union L 324/121 REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) New scientific progress in cellular and molecular biotechnology has led to the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering. This nascent field of biomedicine offers new opportunities for the treatment of diseases and dysfunctions of the human body. (2) Insofar as advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting principally a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3), read in conjunction with the definition of medicinal products in Article 1(2) thereof. Thus, the essential aim of any rules governing their production, distribution and use must be to safeguard public health. (3) For reasons of clarity, complex therapeutic products require precise legal definitions. Gene therapy medicinal products and somatic cell therapy medicinal products have been defined in Annex I to Directive 2001/83/EC, but a legal definition of tissue engineered products remains to be laid down. When products are based on viable cells or tissues, the pharmacological, immunological or metabolic action should be considered as the principal mode of action. It should also be clarified that products which do not meet the definition of a medicinal product, such as products made exclusively of non-viable materials which act primarily by physical means, cannot by definition be advanced therapy medicinal products. (4) According to Directive 2001/83/EC and the Medical Device Directives the basis for deciding which regulatory regime is applicable to combinations of medicinal products and medical devices is the principal mode of action of the combination product. However, the complexity of combined advanced therapy medicinal products containing viable cells or tissues requires a specific approach. For these products, whatever the role of the medical device, the pharmacological, immunological or metabolic action of these cells or tissues should be considered to be the principal mode of action of the combination product. Such combination products should always be regulated under this Regulation. (5) Because of the novelty, complexity and technical specificity of advanced therapy medicinal products, specially tailored and harmonised rules are needed to ensure the free movement of those products within the Community, and the effective operation of the internal market in the biotechnology sector. (6) This Regulation is a lex specialis, which introduces additional provisions to those laid down in Directive 2001/83/EC. The scope of this Regulation should be to regulate advanced therapy medicinal products which are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, in accordance with the general scope of the Community pharmaceutical legislation laid down in Title II of Directive 2001/83/EC. Advanced therapy medicinal products which are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Regulation whilst at the same time ensuring that relevant Community rules related to quality and safety are not undermined. (7) The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells, such as embryonic stem cells, or animal cells. It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells. (8) This Regulation respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union and also takes into account the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. (9) All other modern biotechnology medicinal products currently regulated at Community level are already subject to a centralised authorisation procedure, involving a single scientific evaluation of the quality, safety and efficacy of the product, which is carried out to the highest possible standard by the European Medicines Agency as established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use (4) (hereinafter referred to as the Agency). This procedure should also be compulsory for advanced therapy medicinal products in order to overcome the scarcity of expertise in the Community, ensure a high level of scientific evaluation of these medicinal products in the Community, preserve the confidence of patients and medical professions in the evaluation and facilitate Community market access for these innovative technologies. (10) The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas bordering on other sectors such as biotechnology and medical devices. For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which should be responsible for preparing a draft opinion on the quality, safety and efficacy of each advanced therapy medicinal product for final approval by the Agency\u2019s Committee for Medicinal Products for Human Use. In addition, the Committee for Advanced Therapies should be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence. (11) The Committee for Advanced Therapies should gather the best available expertise on advanced therapy medicinal products in the Community. The composition of the Committee for Advanced Therapies should ensure appropriate coverage of the scientific areas relevant to advanced therapies, including gene therapy, cell therapy, tissue engineering, medical devices, pharmacovigilance and ethics. Patient associations and clinicians with scientific experience of advanced therapy medicinal products should also be represented. (12) To ensure scientific consistency and the efficiency of the system, the Agency should ensure the coordination between the Committee for Advanced Therapies and its other Committees, advisory groups and working parties, notably the Committee for Medicinal Products for Human Use, the Committee on Orphan Medicinal Products, and the Scientific Advice Working Party. (13) Advanced therapy medicinal products should be subject to the same regulatory principles as other types of biotechnology medicinal products. However, technical requirements, in particular the type and amount of quality, pre-clinical and clinical data necessary to demonstrate the quality, safety and efficacy of the product, may be highly specific. While those requirements are already laid down in Annex I to Directive 2001/83/EC for gene therapy medicinal products and somatic cell therapy medicinal products, they need to be established for tissue engineered products. This should be done through a procedure that provides for sufficient flexibility, so as to easily accommodate the rapid evolution of science and technology. (14) Directive 2004/23/EC of the European Parliament and of the Council (5) sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. This Regulation should not derogate from the basic principles laid down in Directive 2004/23/EC, but should supplement them with additional requirements, where appropriate. Where an advanced therapy medicinal product contains human cells or tissues, Directive 2004/23/EC should apply only as far as donation, procurement and testing are concerned, since the further aspects are covered by this Regulation. (15) As regards the donation of human cells or tissues, principles such as the anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient should be respected. As a matter of principle, human cells or tissues contained in advanced therapy medicinal products should be procured from voluntary and unpaid donation. Member States should be urged to take all necessary steps to encourage a strong public and non-profit sector involvement in the procurement of human cells or tissues, as voluntary and unpaid cell and tissue donations may contribute to high safety standards for cells and tissues and therefore to the protection of human health. (16) Clinical trials on advanced therapy medicinal products should be conducted in accordance with the overarching principles and the ethical requirements laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (6). However, Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (7) should be adapted by laying down rules tailored to fully take into account the specific technical characteristics of advanced therapy medicinal products. (17) The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (8), and adapted, where necessary, to reflect the specific nature of those products. Furthermore, guidelines specific to advanced therapy medicinal products should be drawn up, so as to properly reflect the particular nature of their manufacturing process. (18) Advanced therapy medicinal products may incorporate medical devices or active implantable medical devices. Those devices should meet the essential requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (9) and Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (10), respectively, in order to ensure an appropriate level of quality and safety. The results of the assessment of the medical device part or the active implantable medical device part by a notified body in accordance with those Directives should be recognised by the Agency in the evaluation of a combined advanced therapy medicinal product carried out under this Regulation. (19) The requirements in Directive 2001/83/EC as regards the summary of product characteristics, labelling and the package leaflet should be adapted to the technical specificities of advanced therapy medicinal products by laying down specific rules on those products. These rules should comply fully with the patient\u2019s right to know the origin of any cells or tissues used in the preparation of advanced therapy medicinal products, while respecting donor anonymity. (20) Follow-up of efficacy and adverse reactions is a crucial aspect of the regulation of advanced therapy medicinal products. The applicant should therefore detail in its marketing authorisation application whether measures are envisaged to ensure such follow-up and, if so, what those measures are. Where justified on public health grounds, the holder of the marketing authorisation should also be required to put in place a suitable risk management system to address risks related to advanced therapy medicinal products. (21) The operation of this Regulation requires the establishment of guidelines to be drawn up either by the Agency or by the Commission. Open consultation with all interested parties, in particular Member State authorities and the industry, should be carried out in order to allow a pooling of the limited expertise in this area and ensure proportionality. The guidelines on good clinical practice and good manufacturing practice should be laid down as soon as possible, preferably during the first year after entry into force and before the date of application of this Regulation. (22) A system allowing complete traceability of the patient as well as of the product and its starting materials is essential to monitor the safety of advanced therapy medicinal products. The establishment and maintenance of that system should be done in such a way as to ensure coherence and compatibility with traceability requirements laid down in Directive 2004/23/EC in respect of human tissues and cells, and in Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (11). The traceability system should also respect the provisions laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and the free movement of such data (12). (23) As science evolves very rapidly in this field, undertakings developing advanced therapy medicinal products should be enabled to request scientific advice from the Agency, including advice on post-authorisation activities. As an incentive, the fee for that scientific advice should be kept at a minimal level for small and medium-sized enterprises, and should also be reduced for other applicants. (24) The Agency should be empowered to give scientific recommendations on whether a given product based on genes, cells or tissues meets the scientific criteria which define advanced therapy medicinal products, in order to address, as early as possible, questions of borderline with other areas such as cosmetics or medical devices, which may arise as science develops. The Committee for Advanced Therapies, with its unique expertise, should have a prominent role in the provision of such advice. (25) Studies necessary to demonstrate the quality and non-clinical safety of advanced therapy medicinal products are often carried out by small and medium-sized enterprises. As an incentive to conduct those studies, a system of evaluation and certification of the resulting data by the Agency, independently of any marketing authorisation application, should be introduced. Even though the certification would not be legally binding, this system should also aim at facilitating the evaluation of any future application for clinical trials and marketing authorisation application based on the same data. (26) In order to take into account scientific and technical developments, the Commission should be empowered to adopt any necessary changes regarding the technical requirements for applications for marketing authorisation of advanced therapy medicinal products, the summary of product characteristics, labelling, and the package leaflet. The Commission should ensure that relevant information on envisaged measures is made available to interested parties without delay. (27) Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised. (28) The opinions of the Scientific Committee for Medicinal Products and Medical Devices concerning tissue engineering and that of the European Group on Ethics in Science and New Technologies have been taken into account, as well as international experience in this field. (29) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (13). (30) In particular, the Commission should be empowered to adopt amendments to Annexes I to IV to this Regulation and to Annex I to Directive 2001/83/EC. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation and of Directive 2001/83/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. Those measures are essential for the proper operation of the whole regulatory framework and should therefore be adopted as soon as possible. (31) Directive 2001/83/EC and Regulation (EC) No 726/2004 should therefore be amended accordingly, HAVE ADOPTED THIS REGULATION: CHAPTER 1 SUBJECT MATTER AND DEFINITIONS Article 1 Subject matter This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products. Article 2 Definitions 1. In addition to the definitions laid down in Article 1 of Directive 2001/83/EC and in Article 3, points (a) to (l) and (o) to (q) of Directive 2004/23/EC, the following definitions shall apply for the purposes of this Regulation: (a) \u2018Advanced therapy medicinal product\u2019 means any of the following medicinal products for human use: \u2014 a gene therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC, \u2014 a somatic cell therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC, \u2014 a tissue engineered product as defined in point (b). (b) \u2018Tissue engineered product\u2019 means a product that: \u2014 contains or consists of engineered cells or tissues, and \u2014 is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, bio-materials, chemical substances, scaffolds or matrices. Products containing or consisting exclusively of non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, shall be excluded from this definition. (c) Cells or tissues shall be considered \u2018engineered\u2019 if they fulfil at least one of the following conditions: \u2014 the cells or tissues have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved. The manipulations listed in Annex I, in particular, shall not be considered as substantial manipulations, \u2014 the cells or tissues are not intended to be used for the same essential function or functions in the recipient as in the donor. (d) \u2018Combined advanced therapy medicinal product\u2019 means an advanced therapy medicinal product that fulfils the following conditions: \u2014 it must incorporate, as an integral part of the product, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EEC or one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC, and \u2014 its cellular or tissue part must contain viable cells or tissues, or \u2014 its cellular or tissue part containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to. 2. Where a product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues shall be considered as the principal mode of action of the product. 3. An advanced therapy medicinal product containing both autologous (emanating from the patient himself) and allogeneic (coming from another human being) cells or tissues shall be considered to be for allogeneic use. 4. A product which may fall within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product shall be considered as a tissue engineered product. 5. A product which may fall within the definition of: \u2014 a somatic cell therapy medicinal product or a tissue engineered product, and \u2014 a gene therapy medicinal product, shall be considered as a gene therapy medicinal product. CHAPTER 2 MARKETING AUTHORISATION REQUIREMENTS Article 3 Donation, procurement and testing Where an advanced therapy medicinal product contains human cells or tissues, the donation, procurement and testing of those cells or tissues shall be made in accordance with Directive 2004/23/EC. Article 4 Clinical trials 1. The rules set out in Article 6(7) and Article 9(4) and (6) of Directive 2001/20/EC in respect of gene therapy and somatic cell therapy medicinal products shall apply to tissue engineered products. 2. The Commission shall, after consulting the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products. Article 5 Good manufacturing practice The Commission shall, after consulting the Agency, draw up guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products. Article 6 Issues specific to medical devices 1. A medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex I to Directive 93/42/EEC. 2. An active implantable medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex 1 to Directive 90/385/EEC. Article 7 Specific requirements for advanced therapy medicinal products containing devices In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of an advanced therapy medicinal product containing medical devices, bio-materials, scaffolds or matrices shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC. CHAPTER 3 MARKETING AUTHORISATION PROCEDURE Article 8 Evaluation procedure 1. The Committee for Medicinal Products for Human Use shall consult the Committee for Advanced Therapies on any scientific assessment of advanced therapy medicinal products necessary to draw up the scientific opinions referred to in Article 5(2) and (3) of Regulation (EC) No 726/2004. The Committee for Advanced Therapies shall also be consulted in the event of re-examination of the opinion pursuant to Article 9(2) of Regulation (EC) No 726/2004. 2. When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus. If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members. The draft opinion shall mention the divergent positions and the grounds on which they are based. 3. The draft opinion given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the Chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) or Article 9(2) of Regulation (EC) No 726/2004 can be met. 4. Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences. 5. The Agency shall draw up specific procedures for the application of paragraphs 1 to 4. Article 9 Combined advanced therapy medicinal products 1. Where a combined advanced therapy medicinal product is concerned, the whole product shall be subject to final evaluation by the Agency. 2. The application for a marketing authorisation for a combined advanced therapy medicinal product shall include evidence of conformity with the essential requirements referred to in Article 6. 3. The application for a marketing authorisation for a combined advanced therapy medicinal product shall include, where available, the results of the assessment by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device part or active implantable medical device part. The Agency shall recognise the results of that assessment in its evaluation of the medicinal product concerned. The Agency may request the relevant notified body to transmit any information related to the results of its assessment. The notified body shall transmit the information within a period of one month. If the application does not include the results of the assessment, the Agency shall seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the Committee for Advanced Therapies advised by its experts for medical devices decides that involvement of a notified body is not required. CHAPTER 4 SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET Article 10 Summary of product characteristics By way of derogation from Article 11 of Directive 2001/83/EC, the summary of the product characteristics for advanced therapy medicinal products shall contain the information listed in Annex II to this Regulation, in the order indicated therein. Article 11 Labelling of outer/immediate packaging By way of derogation from Articles 54 and 55(1) of Directive 2001/83/EC, the particulars listed in Annex III to this Regulation shall appear on the outer packaging of advanced therapy medicinal products or, where there is no outer packaging, on the immediate packaging. Article 12 Special immediate packaging In addition to the particulars mentioned in Article 55(2) and (3) of Directive 2001/83/EC, the following particulars shall appear on the immediate packaging of advanced therapy medicinal products: (a) the unique donation and product codes, as referred to in Article 8(2) of Directive 2004/23/EC; (b) in the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement \u2018For autologous use only\u2019. Article 13 Package leaflet 1. By way of derogation from Article 59(1) of Directive 2001/83/EC, the package leaflet for an advanced therapy medicinal product shall be drawn up in accordance with the summary of product characteristics and shall include the information listed in Annex IV to this Regulation, in the order indicated therein. 2. The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use. CHAPTER 5 POST-AUTHORISATION REQUIREMENTS Article 14 Post-authorisation follow-up of efficacy and adverse reactions, and risk management 1. In addition to the requirements for pharmacovigilance laid down in Articles 21 to 29 of Regulation (EC) No 726/2004, the applicant shall detail, in the marketing authorisation application, the measures envisaged to ensure the follow-up of efficacy of advanced therapy medicinal products and of adverse reactions thereto. 2. Where there is particular cause for concern, the Commission shall, on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency. In addition, the Agency may request submission of additional reports evaluating the effectiveness of any risk management system and the results of any such studies performed. Evaluation of the effectiveness of any risk management system and the results of any studies performed shall be included in the periodic safety update reports referred to in Article 24(3) of Regulation (EC) No 726/2004. 3. The Agency shall forthwith inform the Commission if it finds that the marketing authorisation holder has failed to comply with the requirements referred to in paragraph 2. 4. The Agency shall draw up detailed guidelines relating to the application of paragraphs 1, 2 and 3. 5. If serious adverse events or reactions occur in relation to a combined advanced therapy medicinal product, the Agency shall inform the relevant national competent authorities responsible for implementing Directives 90/385/EEC, 93/42/EEC and 2004/23/EC. Article 15 Traceability 1. The holder of a marketing authorisation for an advanced therapy medicinal product shall establish and maintain a system ensuring that the individual product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used. 2. The hospital, institution or private practice where the advanced therapy medicinal product is used shall establish and maintain a system for patient and product traceability. That system shall contain sufficient detail to allow linking of each product to the patient who received it and vice versa. 3. Where an advanced therapy medicinal product contains human cells or tissues, the marketing authorisation holder, as well as the hospital, institution or private practice where the product is used, shall ensure that the traceability systems established in accordance with paragraphs 1 and 2 of this Article are complementary to, and compatible with, the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards human blood cells. 4. The marketing authorisation holder shall keep the data referred to in paragraph 1 for a minimum of 30 years after the expiry date of the product, or longer if required by the Commission as a term of the marketing authorisation. 5. In case of bankruptcy or liquidation of the marketing authorisation holder, and in the event that the marketing authorisation is not transferred to another legal entity, the data referred to in paragraph 1 shall be transferred to the Agency. 6. In the event that the marketing authorisation is suspended, revoked or withdrawn, the holder of the marketing authorisation shall remain subject to the obligations laid down in paragraphs 1, 3 and 4. 7. The Commission shall draw up detailed guidelines relating to the application of paragraphs 1 to 6, in particular the type and amount of data referred to in paragraph 1. CHAPTER 6 INCENTIVES Article 16 Scientific advice 1. The applicant or holder of a marketing authorisation may request advice from the Agency on the design and conduct of pharmacovigilance and of the risk management system referred to in Article 14. 2. By way of derogation from Article 8(1) of Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (14), a 90 % reduction for small and medium-sized enterprises and 65 % for other applicants shall apply to the fee for scientific advice payable to the Agency for any advice given in respect of advanced therapy medicinal products pursuant to paragraph 1 of this Article and Article 57(1)(n) of Regulation (EC) No 726/2004. Article 17 Scientific recommendation on advanced therapy classification 1. Any applicant developing a product based on genes, cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product. The Agency shall deliver this recommendation after consultation with the Commission and within 60 days after receipt of the request. 2. The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of commercial confidential nature. Article 18 Certification of quality and non-clinical data Small and medium-sized enterprises developing an advanced therapy medicinal product may submit to the Agency all relevant quality and, where available, non-clinical data required in accordance with modules 3 and 4 of Annex I to Directive 2001/83/EC, for scientific evaluation and certification. The Commission shall lay down provisions for the evaluation and certification of such data, in accordance with the regulatory procedure referred to in Article 26(2). Article 19 Reduction of the fee for marketing authorisation 1. By way of derogation from Regulation (EC) No 297/95, the fee for marketing authorisation shall be reduced by 50 % if the applicant is a hospital or a small or medium-sized enterprise and can prove that there is a particular public health interest in the Community in the advanced therapy medicinal product concerned. 2. Paragraph 1 shall also apply to fees charged by the Agency for post-authorisation activities in the first year following the granting of the marketing authorisation for the advanced therapy medicinal product. 3. Paragraphs 1 and 2 shall apply during the transitional periods laid down in Article 29. CHAPTER 7 COMMITTEE FOR ADVANCED THERAPIES Article 20 Committee for Advanced Therapies 1. A Committee for Advanced Therapies shall be established within the Agency. 2. Save where otherwise provided in this Regulation, Regulation (EC) No 726/2004 shall apply to the Committee for Advanced Therapies. 3. The Executive Director of the Agency shall ensure appropriate coordination between the Committee for Advanced Therapies and the other Committees of the Agency, in particular the Committee for Medicinal Products for Human Use and the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups. Article 21 Composition of the Committee for Advanced Therapies 1. The Committee for Advanced Therapies shall be composed of the following members: (a) five members or co-opted members of the Committee for Medicinal Products for Human Use from five Member States, with alternates either proposed by their respective Member State or, in the case of co-opted members of the Committee for Medicinal Products for Human Use, identified by the latter on the advice of the corresponding co-opted member. These five members with their alternates shall be appointed by the Committee for Medicinal Products for Human Use; (b) one member and one alternate appointed by each Member State whose national competent authority is not represented among the members and alternates appointed by the Committee for Medicinal Products for Human Use; (c) two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent clinicians; (d) two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent patients\u2019 associations. The alternates shall represent and vote for the members in their absence. 2. All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products. For the purposes of paragraph 1(b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies provides appropriate and balanced coverage of the scientific areas relevant to advanced therapies, including medical devices, tissue engineering, gene therapy, cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics. At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices. 3. The members of the Committee for Advanced Therapies shall be appointed for a renewable period of three years. At meetings of the Committee for Advanced Therapies, they may be accompanied by experts. 4. The Committee for Advanced Therapies shall elect its Chairman from among its members for a term of three years, renewable once. 5. The names and scientific qualifications of all members shall be made public by the Agency, in particular on the Agency\u2019s website. Article 22 Conflicts of interest In addition to the requirements laid down in Article 63 of Regulation (EC) No 726/2004, members and alternates of the Committee for Advanced Therapies shall have no financial or other interests in the biotechnology sector and medical device sector that could affect their impartiality. All indirect interests that could relate to these sectors shall be entered in the register referred to in Article 63(2) of Regulation (EC) No 726/2004. Article 23 Tasks of the Committee for Advanced Therapies The Committee for Advanced Therapies shall have the following tasks: (a) to formulate a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use and to advise the latter on any data generated in the development of such a product; (b) to provide advice, pursuant to Article 17, on whether a product falls within the definition of an advanced therapy medicinal product; (c) at the request of the Committee for Medicinal Products for Human Use, to advise on any medicinal product which may require, for the evaluation of its quality, safety or efficacy, expertise in one of the scientific areas referred to in Article 21(2); (d) to provide advice on any question related to advanced therapy medicinal products, at the request of the Executive Director of the Agency or the Commission; (e) to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation; (f) at the Commission\u2019s request, to provide scientific expertise and advice for any Community initiative related to the development of innovative medicines and therapies which requires expertise in one of the scientific areas referred to in Article 21(2); (g) to contribute to the scientific advice procedures referred to in Article 16 of this Regulation and in Article 57(1)(n) of Regulation (EC) No 726/2004. CHAPTER 8 GENERAL AND FINAL PROVISIONS Article 24 Adaptation of Annexes The Commission shall, after consulting the Agency and in accordance with the regulatory procedure with scrutiny referred to in Article 26(3), amend Annexes I to IV in order to adapt them to scientific and technical evolution. Article 25 Report and review By 30 December 2012, the Commission shall publish a general report on the application of this Regulation, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation. In this report, the Commission shall assess the impact of technical progress on the application of this Regulation. It shall also review the scope of this Regulation, including in particular the regulatory framework for combined advanced therapy medicinal products. Article 26 Committee procedure 1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121(1) of Directive 2001/83/EC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 27 Amendments to Regulation (EC) No 726/2004 Regulation (EC) No 726/2004 is hereby amended as follows: 1. in the first subparagraph of Article 13(1), the first sentence shall be replaced by the following: \u2018Without prejudice to Article 4(4) and (5) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community.\u2019; 2. Article 56 shall be amended as follows: (a) in paragraph 1, the following point shall be inserted: \u2018(da) the Committee for Advanced Therapies;\u2019 (b) in the first sentence of the first subparagraph of paragraph 2, the words \u2018paragraph 1(a) to (d)\u2019 shall be replaced by \u2018paragraph 1(a) to (da)\u2019; 3. the Annex shall be amended as follows: (a) the following point shall be inserted: \u20181a. Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products (15). (b) In point 3, the second subparagraph shall be replaced by the following: \u2018After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty.\u2019 Article 28 Amendments to Directive 2001/83/EC Directive 2001/83/EC is hereby amended as follows: 1. in Article 1, the following point shall be inserted: \u20184a. Advanced therapy medicinal product: A product as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products (16). 2. in Article 3, the following point shall be added: \u20187. Any advanced therapy medicinal product, as defined in Regulation (EC) No 1394/2007, which is prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient. Manufacturing of these products shall be authorised by the competent authority of the Member State. Member States shall ensure that national traceability and pharmacovigilance requirements as well as the specific quality standards referred to in this paragraph are equivalent to those provided for at Community level in respect of advanced therapy medicinal products for which authorisation is required pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (17). 3. in Article 4, the following paragraph shall be added: \u20185. This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells, on grounds not dealt with in the aforementioned Community legislation. The Member States shall communicate the national legislation concerned to the Commission. The Commission shall make this information publicly available in a register.\u2019; 4. in Article 6(1), the first subparagraph shall be replaced by the following: \u2018No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1394/2007.\u2019 Article 29 Transitional period 1. Advanced therapy medicinal products, other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation on 30 December 2008, shall comply with this Regulation no later than 30 December 2011. 2. Tissue engineered products which were legally on the Community market in accordance with national or Community legislation on 30 December 2008 shall comply with this Regulation no later than 30 December 2012. 3. By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraphs 1 and 2 of this Article. Article 30 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 30 December 2008. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 13 November 2007. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President M. LOBO ANTUNES (1) OJ C 309, 16.12.2006, p. 15. (2) Opinion of the European Parliament of 25 April 2007 (not yet published in the Official Journal) and Council Decision of 30 October 2007. (3) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1). (4) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006. (5) OJ L 102, 7.4.2004, p. 48. (6) OJ L 121, 1.5.2001, p. 34. Directive as amended by Regulation (EC) No 1901/2006. (7) OJ L 91, 9.4.2005, p. 13. (8) OJ L 262, 14.10.2003, p. 22. (9) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Directive 2007/47/EC of the European Parliament and of the Council (OJ L 247, 21.9.2007, p. 21). (10) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Directive 2007/47/EC. (11) OJ L 33, 8.2.2003, p. 30. (12) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). (13) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (14) OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1). (15) OJ L 324, 10.12.2007, p. 121\u2019; (16) OJ L 324, 10.12.2007, p. 121\u2019; (17) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).\u2019; ANNEX I Manipulations referred to in the first indent of Article 2(1)(c) \u2014 cutting, \u2014 grinding, \u2014 shaping, \u2014 centrifugation, \u2014 soaking in antibiotic or antimicrobial solutions, \u2014 sterilization, \u2014 irradiation, \u2014 cell separation, concentration or purification, \u2014 filtering, \u2014 lyophilization, \u2014 freezing, \u2014 cryopreservation, \u2014 vitrification. ANNEX II Summary of product characteristics referred to in Article 10 1. Name of the medicinal product. Composition of the product: 2.1. general description of the product, if necessary with explanatory drawings and pictures, 2.2. qualitative and quantitative composition in terms of the active substances and other constituents of the product, knowledge of which is essential for proper use, administration or implantation of the product. Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin, shall be provided, For a list of excipients, see point 6.1. 3. Pharmaceutical form. Clinical particulars: 4.1. therapeutic indications, 4.2. posology and detailed instructions for use, application, implantation or administration for adults and, where necessary, for children or other special populations, if necessary with explanatory drawings and pictures, 4.3. contra-indications, 4.4. special warnings and precautions for use, including any special precautions to be taken by persons handling such products and administering them to or implanting them in patients, together with any precautions to be taken by the patient, 4.5. interaction with other medicinal products and other forms of interactions, 4.6. use during pregnancy and lactation, 4.7. effects on ability to drive and to use machines, 4.8. undesirable effects, 4.9. overdose (symptoms, emergency procedures). Pharmacological properties: 5.1. pharmacodynamic properties, 5.2. pharmacokinetic properties, 5.3. preclinical safety data. Quality particulars: 6.1. list of excipients, including preservative systems, 6.2. incompatibilities, 6.3. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time, 6.4. special precautions for storage, 6.5. nature and contents of container and special equipment for use, administration or implantation, if necessary with explanatory drawings and pictures, 6.6. special precautions and instructions for handling and disposal of a used advanced therapy medicinal product or waste materials derived from such product, if appropriate and, if necessary, with explanatory drawings and pictures. 7. Marketing authorisation holder. 8. Marketing authorisation number(s). 9. Date of the first authorisation or renewal of the authorisation. 10. Date of revision of the text. ANNEX III Labelling of outer/immediate packaging referred to in Article 11 (a) The name of the medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults; the international non-proprietary name (INN) shall be included, or, if the product has no INN, the common name; (b) A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement \u2018This product contains cells of human/animal [as appropriate{] origin\u2019 together with a short description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin; (c) The pharmaceutical form and, if applicable, the contents by weight, by volume or by number of doses of the product; (d) A list of excipients, including preservative systems; (e) The method of use, application, administration or implantation and, if necessary, the route of administration. If applicable, space shall be provided for the prescribed dose to be indicated; (f) A special warning that the medicinal product must be stored out of the reach and sight of children; (g) Any special warning necessary for the particular medicinal product; (h) The expiry date in clear terms (month and year; and day if applicable); (i) Special storage precautions, if any; (j) Specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place; (k) The name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him; (l) Marketing authorisation number(s); (m) The manufacturer\u2019s batch number and the unique donation and product codes referred to in Article 8(2) of Directive 2004/23/EC; (n) In the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement \u2018For autologous use only\u2019. ANNEX IV Package leaflet referred to in Article 13 (a) For the identification of the advanced therapy medicinal product: (i) the name of the advanced therapy medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults. The common name shall be included; (ii) the therapeutic group or type of activity in terms easily understandable for the patient; (iii) where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin; (iv) where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin; (b) The therapeutic indications; (c) A list of information which is necessary before the medicinal product is taken or used, including: (i) contra-indications; (ii) appropriate precautions for use; (iii) forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product; (iv) special warnings; (v) if appropriate, possible effects on the ability to drive vehicles or to operate machinery; (vi) the excipients, knowledge of which is important for the safe and effective use of the medicinal product and which are included in the detailed guidance published pursuant to Article 65 of Directive 2001/83/EC. The list shall also take into account the particular condition of certain categories of users, such as children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions; (d) The necessary and usual instructions for proper use, and in particular: (i) the posology; (ii) the method of use, application, administration or implantation and, if necessary, the route of administration; and, as appropriate, depending on the nature of the product: (iii) the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered; (iv) the duration of treatment, where it should be limited; (v) the action to be taken in case of an overdose (such as symptoms, emergency procedures); (vi) information on what to do when one or more doses have not been taken; (vii) a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product; (e) A description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly asked to communicate any adverse reaction which is not mentioned in the package leaflet to his doctor or pharmacist; (f) A reference to the expiry date indicated on the label, with: (i) a warning against using the product after that date; (ii) where appropriate, special storage precautions; (iii) if necessary, a warning concerning certain visible signs of deterioration; (iv) the full qualitative and quantitative composition; (v) the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States; (vi) the name and address of the manufacturer; (g) The date on which the package leaflet was last revised.", "summary": "EU rules for new medical products based on genes and cells EU rules for new medical products based on genes and cells SUMMARY Scientific advances bring new medicinal products based on gene or somatic-cell* therapy and tissue engineering* to treat human diseases. Since December 2008, legislation aims to ensure these are both safe for patients and can be available throughout the EU. WHAT DOES THE REGULATION DO? It lays down rules for authorising, supervising and monitoring advanced therapy medicinal products, known in the jargon as ATMPs. These can be used, for instance, in correcting knee cartilage defects in adults. The legislation protects patients from scientifically unsound treatments. KEY POINTS \u2014 The legislation creates a Committee for Advanced Therapies (CAT) within the European Medicines Agency. Its role is to give scientific opinions on the quality, safety and efficacy of advanced therapy medicinal products. \u2014 The Committee for Medicinal Products for Human Use bases its authorisation decisions on the CAT\u2019s opinions. \u2014 Once authorisation is granted, the item is considered safe for human use throughout Europe. \u2014 Manufacturers must comply with detailed labelling and packaging rules. \u2014 Manufacturers must ensure that each product, and its raw materials, can be traced from initial sourcing through packaging, storage and delivery to its final destination. \u2014 Hospitals and other medical locations must maintain traceability systems for both patients and the products used. \u2014 Manufacturers must specify the remedial measures they will take if an authorised product is found to cause adverse reactions. \u2014 Where there is particular cause for concern, the European Commission may request a manufacturer to establish a risk management system to identify, prevent or minimise any possible risks. \u2014 The Commission draws up detailed guidelines on good clinical and manufacturing practice specific to advanced therapy medicinal products. A Commission report of March 2014 examined the status of advanced therapies in the EU and how the regulation had worked in practice. It noted that the legislation had established a recognised framework for assessing new advanced therapies. BACKGROUND Significant research takes place in the EU into advanced therapies. The EU\u2019s clinical trials database, EudraCT, recorded up to 250 between 2004 and 2010. Almost 70 % of the entities involved were SMEs or not-for-profit organisations. Multinational pharmaceutical companies accounted for under 2 %. KEY TERMS * Somatic-cell therapy: experimental method of cloning genes and reintroducing them into cells to correct an inherited disease. * Tissue engineering: manufacture of organs to be implanted and used in the human body. ACT Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 1394/2007 30.12.2007 \u2013 OJ L 324, 10.12.2007, pp. 121\u2013137 Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 1235/2010 1.1.2011 \u2013 OJ L 348, 31.12.2010, pp. 1\u201316 RELATED ACTS Report from the Commission to the European Parliament and the Council in accordance with Article 25 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (COM(2014) 188 final of 28.3.2014) last update 15.10.2015"}
{"article": "29.6.2007 EN Official Journal of the European Union L 171/1 REGULATION (EC) No 715/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital must be ensured. To that end a comprehensive Community type approval system for motor vehicles, established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (3), is in place. The technical requirements for the type approval of motor vehicles with regard to emissions should therefore be harmonised to avoid requirements that differ from one Member State to another, and to ensure a high level of environmental protection. (2) This Regulation is one of a number of separate regulatory acts in the context of the Community type approval procedure under Directive 70/156/EEC. Therefore, that Directive should be amended accordingly. (3) At the request of the European Parliament a new regulatory approach has been introduced in EU vehicle legislation. Thus, this Regulation lays down fundamental provisions on vehicle emissions, whereas the technical specifications will be laid down by implementing measures adopted following comitology procedures. (4) In March 2001 the Commission launched the Clean Air For Europe (CAFE) programme, the major elements of which are outlined in a communication of 4 May 2005. This has led to the adoption of a thematic strategy on air pollution by a communication of 21 September 2005. One of the conclusions of the thematic strategy is that further reductions in emissions from the transport sector (air, maritime and land transport), from households and from the energy, agricultural and industrial sectors are needed to achieve EU air quality objectives. In this context, the task of reducing vehicle emissions should be approached as part of an overall strategy. The Euro 5 and 6 standards are one of the measures designed to reduce emissions of particulate matter and ozone precursors such as nitrogen oxides and hydrocarbons. (5) Achieving EU air quality objectives requires a continuing effort to reduce vehicle emissions. For that reason, industry should be provided with clear information on future emission limit values. This is why this Regulation includes, in addition to Euro 5, the Euro 6 stage of emission limit values. (6) In particular, a considerable reduction in nitrogen oxide emissions from diesel vehicles is necessary to improve air quality and comply with limit values for pollution. This requires reaching ambitious limit values at the Euro 6 stage without being obliged to forego the advantages of diesel engines in terms of fuel consumption and hydrocarbon and carbon monoxide emissions. Setting such a step for reducing nitrogen oxide emissions at an early stage will provide long-term, Europe-wide planning security for vehicle manufacturers. (7) In setting emissions standards it is important to take into account the implications for markets and manufacturers' competitiveness, the direct and indirect costs imposed on business and the benefits that accrue in terms of stimulating innovation, improving air quality, reducing health costs and increasing life expectancy, as well as the implications for the overall impact on carbon dioxide emissions. (8) Unrestricted access to vehicle repair information, via a standardised format which can be used to retrieve the technical information, and effective competition on the market for vehicle repair and maintenance information services are necessary to improve the functioning of the internal market, particularly as regards the free movement of goods, freedom of establishment and freedom to provide services. A great proportion of such information is related to on-board diagnostic (OBD) systems and their interaction with other vehicle systems. It is appropriate to lay down technical specifications that manufacturers' websites should follow, along with targeted measures to ensure reasonable access for small and medium-sized enterprises (SMEs). Common standards agreed with the involvement of stakeholders, such as the OASIS (4) format, can facilitate the exchange of information between manufacturers and service providers. It is therefore appropriate to initially require the use of the technical specifications of the OASIS format and to ask the Commission to request CEN/ISO to further develop this format into a standard with a view to replacing the OASIS format in due course. (9) Not later than four years after the date of entry into force of this Regulation, the Commission should review the operation of the system of access to all vehicle repair and maintenance information with a view to determining whether it would be appropriate to consolidate all provisions governing access to vehicle repair and maintenance information within a revised framework Directive on type approval. If the provisions governing access to all vehicle information are incorporated into that Directive, the corresponding provisions in this Regulation should be repealed, as long as the existing rights for access to repair and maintenance information are preserved. (10) The Commission should keep under review emissions which are as yet unregulated and which arise as a consequence of the wider use of new fuel formulations, engine technologies and emission control systems and, where necessary, submit a proposal to the European Parliament and to the Council with a view to regulating such emissions. (11) In order to facilitate the introduction and to maintain the existence of alternative fuel vehicles, which can have low nitrogen oxide and particulate emissions, and at the same time to encourage reduced emissions from petrol-powered vehicles, this Regulation introduces separate limit values for total hydrocarbons and total non-methane hydrocarbons. (12) Efforts should be continued to implement stricter emission limits, including reduction of carbon dioxide emissions, and to ensure that those limits relate to the actual performance of vehicles when in use. (13) In order to ensure that emissions of ultra fine particulate matter (PM 0,1 \u00b5m and below) are controlled, the Commission should adopt as soon as possible, and introduce at the latest upon entry into force of the Euro 6 stage, a number based approach to emissions of PM in addition to the mass based approach which is currently used. The number based approach to emissions of PM should draw on the results of the UN/ECE's Particulate Measurement Programme (PMP) and be consistent with the existing ambitious objectives for the environment. (14) To provide greater repeatability in measuring the mass and number of particulate emissions in the laboratory, the Commission should adopt a new measurement procedure replacing the current one. This should be introduced as soon as possible and at the latest upon entry into force of the Euro 6 stage. It should be based on the results of the PMP. When the new measurement procedure is implemented, the PM mass emission limits set out in this Regulation should be recalibrated, as the new procedure records a lower level of mass than the current one. (15) The Commission should keep under review the need to revise the New European Drive Cycle as the test procedure that provides the basis of EC type approval emissions regulations. Updating or replacement of the test cycles may be required to reflect changes in vehicle specification and driver behaviour. Revisions may be necessary to ensure that real world emissions correspond to those measured at type approval. The use of portable emission measurement systems and the introduction of the \u2018not-to-exceed\u2019 regulatory concept should also be considered. (16) OBD systems are important in the control of emissions during the use of a vehicle. Due to the importance of controlling real world emissions, the Commission should keep under review the requirements for such systems and the tolerance thresholds for monitoring faults. (17) A standardised method of measuring fuel consumption and carbon dioxide emissions of vehicles is necessary to ensure that no technical barriers to trade arise between Member States. Furthermore, it is also necessary to ensure that customers and users are supplied with objective and precise information. (18) Before drawing up a proposal for future emission standards, the Commission should set up studies designed to determine whether the continued subdivision of vehicle categories into groups is still necessary and whether mass neutral emission limits can be applied. (19) Member States should be able, by means of financial incentives, to accelerate the placing on the market of vehicles which satisfy the requirements adopted at Community level. However, such incentives should comply with the provisions of the Treaty, in particular the rules on state aid. This is in order to avoid distortions of the internal market. This Regulation should not affect the Member States\u2019 right to include emissions in the basis for calculating taxes levied on vehicles. (20) Given that the legislation on vehicle emissions and fuel consumption has developed over more than 35 years and is now spread over more than 24 Directives, it is advisable to replace those Directives by a new regulation and a number of implementing measures. A regulation will ensure that the detailed technical provisions are directly applicable to manufacturers, approval authorities and technical services and that they can be updated in a much faster and more efficient way. Directives 70/220/EEC (5), 72/306/EEC (6), 74/290/EEC (7), 80/1268/EEC (8), 83/351/EEC (9), 88/76/EEC (10), 88/436/EEC (11), 89/458/EEC (12), 91/441/EEC (13), 93/59/EEC (14), 94/12/EC (15), 96/69/EC (16), 98/69/EC (17), 2001/1/EC (18), 2001/100/EC (19) and 2004/3/EC (20) should therefore be repealed. In addition, the Member States should also repeal the transposing legislation of the repealed Directives. (21) In order to clarify the scope of legislation on vehicle emissions, Directive 2005/55/EC of the European Parliament and of the Council of 28 September 2005 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive-ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles (21) should be amended in such a way as to cover all heavy-duty vehicles so as to make clear that this Regulation concerns light-duty vehicles. (22) To ensure a smooth transition from the existing Directives to this Regulation, the applicability of this Regulation should be deferred by a certain period after its entry into force. However, during that period manufacturers should be able to choose to have vehicles approved under either the existing Directives or this Regulation. Moreover, the provisions on financial incentives should be applicable immediately after the entry into force of this Regulation. The validity of type approvals granted under the existing Directives is not to be affected by the entry into force of this Regulation. (23) To ensure a smooth transition from the existing Directives to this Regulation, certain exceptions for vehicles designed to fulfil specific social needs should be foreseen in the Euro 5 stage. These exceptions should cease with the entry into force of the Euro 6 stage. (24) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (22). (25) In particular, power should be conferred on the Commission to introduce particle number based limit values in Annex I, as well as to recalibrate the particulate mass based limit values set out in that Annex. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (26) Power should also be conferred on the Commission to establish specific procedures, tests and requirements for type approval, as well as a revised measurement procedure for particulates and a particle number based limit value, and to adopt measures concerning the use of defeat devices, access to vehicle repair and maintenance information and test cycles used to measure emissions. Since those measures are of general scope and are designed to supplement this Regulation by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (27) Since the objectives of this Regulation, namely the realisation of the internal market through the introduction of common technical requirements concerning emissions from motor vehicles and guaranteed access to vehicle repair and maintenance information for independent operators on the same basis as for authorised dealers and repairers, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter 1. This Regulation establishes common technical requirements for the type approval of motor vehicles (vehicles) and replacement parts, such as replacement pollution control devices, with regard to their emissions. 2. In addition, this Regulation lays down rules for in-service conformity, durability of pollution control devices, on-board diagnostic (OBD) systems, measurement of fuel consumption and accessibility of vehicle repair and maintenance information. Article 2 Scope 1. This Regulation shall apply to vehicles of categories M1, M2, N1 and N2 as defined in Annex II to Directive 70/156/EEC with a reference mass not exceeding 2 610 kg. 2. At the manufacturer's request, type approval granted under this Regulation may be extended from vehicles covered by paragraph 1 to M1, M2, N1 and N2 vehicles as defined in Annex II to Directive 70/156/EEC with a reference mass not exceeding 2 840 kg and which meet the conditions laid down in this Regulation and its implementing measures. Article 3 Definitions For the purposes of this Regulation and its implementing measures the following definitions shall apply: 1. \u2018hybrid vehicle\u2019 means a vehicle with at least two different energy converters and two different energy storage systems (on vehicle) for the purpose of vehicle propulsion; 2. \u2018vehicles designed to fulfil specific social needs\u2019 means diesel vehicles of category M1 which are either: (a) special purpose vehicles as defined in Directive 70/156/EEC with a reference mass exceeding 2 000 kg; (b) vehicles with a reference mass exceeding 2 000 kg and designed to carry seven or more occupants including the driver with the exclusion, as from 1 September 2012, of vehicles of category M1G as defined in Directive 70/156/EEC; or (c) vehicles with a reference mass exceeding 1 760 kg which are built specifically for commercial purposes to accommodate wheelchair use inside the vehicle; 3. \u2018reference mass\u2019 means the mass of the vehicle in running order less the uniform mass of the driver of 75 kg and increased by a uniform mass of 100 kg; 4. \u2018gaseous pollutants\u2019 means the exhaust gas emissions of carbon monoxide, oxides of nitrogen, expressed in nitrogen dioxide (NO2) equivalent, and hydrocarbons; 5. \u2018particulate pollutants\u2019 means components of the exhaust gas which are removed from the diluted exhaust gas at a maximum temperature of 325 \u00b0K (52 \u00b0C) by means of the filters described in the test procedure for verifying average tailpipe emissions; 6. \u2018tailpipe emissions\u2019 means the emission of gaseous and particulate pollutants; 7. \u2018evaporative emissions\u2019 means the hydrocarbon vapours emitted from the fuel system of a vehicle other than those from tailpipe emissions; 8. \u2018crankcase\u2019 means the spaces in, or external to, an engine which are connected to the oil sump by internal or external ducts through which gases and vapours can be emitted; 9. \u2018on-board diagnostic system\u2019 or \u2018OBD system\u2019 means a system for emission control which has the capability of identifying the likely area of malfunction by means of fault codes stored in a computer memory; 10. \u2018defeat device\u2019 means any element of design which senses temperature, vehicle speed, engine speed (RPM), transmission gear, manifold vacuum or any other parameter for the purpose of activating, modulating, delaying or deactivating the operation of any part of the emission control system, that reduces the effectiveness of the emission control system under conditions which may reasonably be expected to be encountered in normal vehicle operation and use; 11. \u2018pollution control device\u2019 means those components of a vehicle that control and/or limit tailpipe and evaporative emissions; 12. \u2018original pollution control device\u2019 means a pollution control device or an assembly of such devices covered by the type approval granted for the vehicle concerned; 13. \u2018replacement pollution control device\u2019 means a pollution control device or an assembly of such devices intended to replace an original pollution control device and which can be approved as a separate technical unit as defined in Directive 70/156/EEC; 14. \u2018vehicle repair and maintenance information\u2019 means all information required for diagnosis, servicing, inspection, periodic monitoring, repair, re-programming or re-initialising of the vehicle and which the manufacturers provide for their authorised dealers and repairers, including all subsequent amendments and supplements to such information. This information includes all information required for fitting parts or equipment on vehicles; 15. \u2018independent operator\u2019 means undertakings other than authorised dealers and repairers which are directly or indirectly involved in the repair and maintenance of motor vehicles, in particular repairers, manufacturers or distributors of repair equipment, tools or spare parts, publishers of technical information, automobile clubs, roadside assistance operators, operators offering inspection and testing services, operators offering training for installers, manufacturers and repairers of equipment for alternative fuel vehicles; 16. \u2018biofuels\u2019 means liquid or gaseous fuels for transport, produced from biomass; 17. \u2018alternative fuel vehicle\u2019 means a vehicle designed to be capable of running on at least one type of fuel that is either gaseous at atmospheric temperature and pressure, or substantially non-mineral oil derived. CHAPTER II MANUFACTURERS\u2019 TYPE-APPROVAL OBLIGATIONS Article 4 Manufacturers\u2019 obligations 1. Manufacturers shall demonstrate that all new vehicles sold, registered or put into service in the Community are type approved in accordance with this Regulation and its implementing measures. Manufacturers shall also demonstrate that all new replacement pollution control devices requiring type approval which are sold or put into service in the Community are type approved in accordance with this Regulation and its implementing measures. These obligations include meeting the emission limits set out in Annex I and the implementing measures referred to in Article 5. 2. Manufacturers shall ensure that type approval procedures for verifying conformity of production, durability of pollution control devices and in-service conformity are met. In addition, the technical measures taken by the manufacturer must be such as to ensure that the tailpipe and evaporative emissions are effectively limited, pursuant to this Regulation, throughout the normal life of the vehicles under normal conditions of use. Therefore, in-service conformity measures shall be checked for a period of up to five years or 100 000 km, whichever is the sooner. Durability testing of pollution control devices undertaken for type approval shall cover 160 000 km. To comply with this durability test, the manufacturers should have the possibility to make use of test bench ageing, subject to the implementing measures referred to in paragraph 4. In-service conformity shall be checked, in particular, for tailpipe emissions as tested against emission limits set out in Annex I. In order to improve control of evaporative emissions and low ambient temperature emissions, the test procedures shall be reviewed by the Commission. 3. Manufacturers shall set out carbon dioxide emissions and fuel consumption figures in a document given to the purchaser of the vehicle at the time of purchase. 4. The specific procedures and requirements for the implementation of paragraphs 2 and 3 shall be established in accordance with the procedure referred to in Article 15(2). Article 5 Requirements and tests 1. The manufacturer shall equip vehicles so that the components likely to affect emissions are designed, constructed and assembled so as to enable the vehicle, in normal use, to comply with this Regulation and its implementing measures. 2. The use of defeat devices that reduce the effectiveness of emission control systems shall be prohibited. The prohibition shall not apply where: (a) the need for the device is justified in terms of protecting the engine against damage or accident and for safe operation of the vehicle; (b) the device does not function beyond the requirements of engine starting; or (c) the conditions are substantially included in the test procedures for verifying evaporative emissions and average tailpipe emissions. 3. The specific procedures, tests and requirements for type approval set out in this paragraph, as well as requirements for the implementation of paragraph 2, which are designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). This shall include establishing the requirements relating to: (a) tailpipe emissions, including test cycles, low ambient temperature emissions, emissions at idling speed, smoke opacity and correct functioning and regeneration of after-treatment systems; (b) evaporative emissions and crankcase emissions; (c) OBD systems and in-use performance of pollution control devices; (d) durability of pollution control devices, replacement pollution control devices, in-service conformity, conformity of production and roadworthiness; (e) measurement of greenhouse gas emissions and fuel consumption; (f) hybrid vehicles and alternative fuel vehicles; (g) extension of type approvals and requirements for small volume manufacturers; (h) test equipment; and (i) reference fuels, such as petrol, diesel, gaseous fuels and biofuels, such as bioethanol, biodiesel and biogas. The above requirements shall, where relevant, apply to vehicles regardless of the type of fuel by which they are powered. CHAPTER III ACCESS TO VEHICLE REPAIR AND MAINTENANCE INFORMATION Article 6 Manufacturers' obligations 1. Manufacturers shall provide unrestricted and standardised access to vehicle repair and maintenance information to independent operators through websites using a standardised format in a readily accessible and prompt manner, and in a manner which is non-discriminatory compared to the provision given or access granted to authorised dealers and repairers. With a view to facilitating the achievement of this objective, the information shall be submitted in a consistent manner, initially in accordance with the technical requirements of the OASIS format (23). Manufacturers shall also make training material available to independent operators and authorised dealers and repairers. 2. The information referred to in paragraph 1 shall include: (a) an unequivocal vehicle identification; (b) service handbooks; (c) technical manuals; (d) component and diagnosis information (such as minimum and maximum theoretical values for measurements); (e) wiring diagrams; (f) diagnostic trouble codes (including manufacturer specific codes); (g) the software calibration identification number applicable to a vehicle type; (h) information provided concerning, and delivered by means of, proprietary tools and equipment; and (i) data record information and two-directional monitoring and test data. 3. Authorised dealers or repairers within the distribution system of a given vehicle manufacturer shall be regarded as independent operators for the purposes of this Regulation to the extent that they provide repair or maintenance services for vehicles in respect of which they are not members of the vehicle manufacturer's distribution system. 4. The vehicle repair and maintenance information shall always be available, except as required for maintenance purposes of the information system. 5. For the purposes of manufacture and servicing of OBD-compatible replacement or service parts and diagnostic tools and test equipment, manufacturers shall provide the relevant OBD and vehicle repair and maintenance information on a non-discriminatory basis to any interested component, diagnostic tools or test equipment manufacturer or repairer. 6. For the purposes of the design and manufacture of automotive equipment for alternative fuel vehicles, manufacturers shall provide the relevant OBD and vehicle repair and maintenance information on a non-discriminatory basis to any interested manufacturer, installer or repairer of equipment for alternative fuel vehicles. 7. When applying for EC type approval or national type approval, the manufacturer shall provide the type approval authority with proof of compliance with this Regulation relating to access to vehicle repair and maintenance information and to the information referred to in paragraph 5. In the event that such information is not yet available, or does not yet conform to this Regulation and its implementing measures at that point in time, the manufacturer shall provide it within six months from the date of type approval. If such proof of compliance is not provided within that period, the approval authority shall take appropriate measures to ensure compliance. The manufacturer shall make subsequent amendments and supplements to vehicle repair and maintenance information available on its websites at the same time they are made available to authorised repairers. Article 7 Fees for access to vehicle repair and maintenance information 1. Manufacturers may charge reasonable and proportionate fees for access to vehicle repair and maintenance information covered by this Regulation; a fee is not reasonable or proportionate if it discourages access by failing to take into account the extent to which the independent operator uses it. 2. Manufacturers shall make available vehicle repair and maintenance information on a daily, monthly, and yearly basis, with fees for access to such information varying in accordance with the respective periods of time for which access is granted. Article 8 Implementing measures The measures necessary for implementation of Articles 6 and 7, which are designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). This shall include the definition and updating of technical specifications relating to the way in which OBD and vehicle repair and maintenance information shall be provided, with special attention being paid to the specific needs of SMEs. Article 9 Report Not later than 2 July 2011, the Commission shall present to the European Parliament and to the Council a report on the operation of the system of access to vehicle repair and maintenance information, with particular consideration being given to the effect on competition and the operation of the internal market and the environmental benefits. The report shall consider whether it would be appropriate to consolidate all provisions governing access to vehicle repair and maintenance information within a revised framework directive on type approval. CHAPTER IV OBLIGATIONS OF MEMBER STATES Article 10 Type approval 1. With effect from 2 July 2007, if a manufacturer so requests, the national authorities may not, on grounds relating to emissions or fuel consumption of vehicles, refuse to grant EC type approval or national type approval for a new type of vehicle, or prohibit the registration, sale or entry into service of a new vehicle, where the vehicle concerned complies with this Regulation and its implementing measures, and in particular with the Euro 5 limit values set out in Table 1 of Annex I or with the Euro 6 limit values set out in Table 2 of Annex I. 2. With effect from 1 September 2009, and from 1 September 2010 in the case of category N1 class II and III and category N2 vehicles, the national authorities shall refuse, on grounds relating to emissions or fuel consumption, to grant EC type approval or national type approval for new types of vehicle which do not comply with this Regulation and its implementing measures, and in particular with the Annexes, with the exception of the Euro 6 limit values set out in Table 2 of Annex I. For the test on tailpipe emissions, the limit values applied to vehicles designed to fulfil specific social needs shall be the same as for category N1 class III vehicles. 3. With effect from 1 January 2011, and from 1 January 2012 in the case of category N1 class II and III and category N2 vehicles and vehicles designed to fulfil specific social needs, national authorities shall, in the case of new vehicles which do not comply with this Regulation and its implementing measures, and in particular with the Annexes with the exception of the Euro 6 limit values set out in Table 2 of Annex I, consider certificates of conformity to be no longer valid for the purposes of Article 7(1) of Directive 70/156/EEC and shall, on grounds relating to emissions or fuel consumption, prohibit the registration, sale or entry into service of such vehicles. For the test on tailpipe emissions, the limit values applied to vehicles designed to fulfil specific social needs shall be the same as for category N1 class III vehicles. 4. With effect from 1 September 2014, and from 1 September 2015 in the case of category N1 class II and III and category N2 vehicles, the national authorities shall refuse, on grounds relating to emissions or fuel consumption, to grant EC type approval or national type approval for new types of vehicle which do not comply with this Regulation and its implementing measures, and in particular with the Euro 6 limit values set out in Table 2 of Annex I. 5. With effect from 1 September 2015, and from 1 September 2016 in the case of category N1 class II and III and category N2 vehicles, national authorities shall, in the case of new vehicles which do not comply with this Regulation and its implementing measures, and in particular with the Euro 6 limit values set out in Table 2 of Annex I, consider certificates of conformity to be no longer valid for the purposes of Article 7(1) of Directive 70/156/EEC and shall, on grounds relating to emissions or fuel consumption, prohibit the registration, sale or entry into service of such vehicles. Article 11 Type approval of replacement parts 1. For new replacement pollution control devices intended to be fitted on vehicles approved under this Regulation, national authorities shall prohibit their sale or installation on a vehicle if they are not of a type in respect of which a type approval has been granted in compliance with this Regulation and its implementing measures. 2. National authorities may continue to grant extensions to EC type approvals for replacement pollution control devices intended for standards preceding this Regulation under the terms which originally applied. National authorities shall prohibit the sale or installation on a vehicle of such replacement pollution control devices unless they are of a type in respect of which a relevant type approval has been granted. 3. Replacement pollution control devices intended to be fitted on vehicles type approved prior to the adoption of component type approval requirements are exempt from the requirements of paragraphs 1 and 2. Article 12 Financial incentives 1. Member States may make provision for financial incentives that apply to vehicles in series production which comply with this Regulation and its implementing measures. Those incentives shall be valid for all new vehicles offered for sale on the market of a Member State which comply at least with the emission limit values in Table 1 of Annex I in advance of the dates set out in Article 10(3); they shall cease on those dates. Financial incentives that apply exclusively to vehicles which comply with the emission limit values in Table 2 of Annex I may be granted for such new vehicles offered for sale on the market of a Member State from the dates set out in Article 10(3) in advance of the dates set out in Article 10(5); they shall cease on the dates set out in Article 10(5). 2. Member States may grant financial incentives for the retrofitting of in-use vehicles and for scrapping vehicles which do not comply. 3. For each type of vehicle, the financial incentives referred to in paragraphs 1 and 2 shall not exceed the additional cost of the technical devices introduced to ensure compliance with the emission limits specified in Annex I, including the cost of installation on the vehicle. 4. The Commission shall be informed in sufficient time of plans to institute or change the financial incentives referred to in paragraphs 1 and 2. Article 13 Penalties 1. Member States shall lay down the provisions on penalties applicable for infringement by manufacturers of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 2 January 2009 and shall notify it without delay of any subsequent amendment affecting them. 2. The types of infringements which are subject to a penalty shall include: (a) making false declarations during the approval procedures or procedures leading to a recall; (b) falsifying test results for type approval or in-service conformity; (c) withholding data or technical specifications which could lead to recall or withdrawal of type approval; (d) use of defeat devices; and (e) refusal to provide access to information. CHAPTER V FINAL PROVISIONS Article 14 Redefinition of specifications 1. The Commission shall consider including methane emissions in the calculation of carbon dioxide emissions. If necessary, the Commission shall present a proposal to the European Parliament and the Council with measures to account for, or limit, methane emissions. 2. After the completion of the UN/ECE Particulate Measurement Programme, conducted under the auspices of the World Forum for Harmonisation of Vehicle Regulations, and at the latest upon entry into force of Euro 6, the Commission shall adopt the following measures, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, without lowering the existing ambition level with regard to the environment: (a) amendment of this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 15(3) for the purpose of recalibrating the particulate mass based limit values set out in Annex I to this Regulation, and introducing particle number based limit values in that Annex so that they correlate broadly with the petrol and diesel mass limit values; (b) adoption of a revised measurement procedure for particulates and a particle number limit value, in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). 3. The Commission shall keep under review the procedures, tests and requirements referred to in Article 5(3) as well as the test cycles used to measure emissions. If the review finds that these are no longer adequate or no longer reflect real world emissions, they shall be adapted so as to adequately reflect the emissions generated by real driving on the road. The necessary measures, which are designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). 4. The Commission shall keep under review the pollutants subject to the requirements and tests referred to in Article 5(3). If the Commission concludes that it is appropriate to regulate the emissions of additional pollutants it shall present a proposal to the European Parliament and to the Council to amend this Regulation accordingly. 5. The Commission shall review the emission limits set out in Table 4 of Annex I for the carbon monoxide and hydrocarbon tailpipe emissions after a cold start test and shall present, as appropriate, a proposal to the European Parliament and to the Council with a view to tightening the emission limits. 6. The relevant Annexes of Directive 2005/55/EC shall be amended in accordance with the regulatory procedure with scrutiny referred to in Article 15(3) so that they contain requirements for the type approval of all vehicles covered by the scope of that Directive. Article 15 Committee procedure 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 16 Amendments to Directives 70/156/EEC and 2005/55/EC 1. Directive 70/156/EEC shall be amended in accordance with Annex II to this Regulation. 2. Directive 2005/55/EC is hereby amended as follows: (a) The title shall be replaced by the following: \u2018Directive 2005/55/EC of the European Parliament and of the Council of 28 September 2005 on type approval of heavy duty vehicles and engines with respect to their emissions (Euro IV and V)\u2019; (b) Article 1 shall be replaced by the following: \u2018Article 1 For the purposes of this Directive the following definitions shall apply: (a) \u201cvehicle\u201d means any motor vehicle as defined in Article 2 of Directive 70/156/EEC with a reference mass exceeding 2 610 kg; (b) \u201cengine\u201d means the motive propulsion source of a vehicle for which type-approval as a separate technical unit, as defined in Article 2 of Directive 70/156/EEC, may be granted; (c) \u201cenhanced environment-friendly vehicle (EEV)\u201d means a vehicle propelled by an engine which complies with the permissive emission limit values set out in row C of the tables in Section 6.2.1 of Annex I.\u2019; (c) Section 1 of Annex I shall be replaced by the following: \u20181. This Directive applies to the control of gaseous and particulate pollutants, useful life of emission control devices, conformity of in-service vehicles/engines and on-board diagnostic (OBD) systems of all motor vehicles, and to engines as specified in Article 1 with the exception of those vehicles of category M1, N1, N2 and M2 for which type-approval has been granted under Regulation (EC) No 715/2007 (24). Article 17 Repeal 1. The following Directives shall be repealed with effect from 2 January 2013: \u2014 Directive 70/220/EEC, \u2014 Directive 72/306/EEC, \u2014 Directive 74/290/EEC, \u2014 Directive 77/102/EEC, \u2014 Directive 78/665/EEC, \u2014 Directive 80/1268/EEC, \u2014 Directive 83/351/EEC, \u2014 Directive 88/76/EEC, \u2014 Directive 88/436/EEC, \u2014 Directive 89/458/EEC, \u2014 Directive 91/441/EEC, \u2014 Directive 93/59/EEC, \u2014 Directive 93/116/EC, \u2014 Directive 94/12/EC, \u2014 Directive 96/44/EC, \u2014 Directive 96/69/EC, \u2014 Directive 98/69/EC, \u2014 Directive 98/77/EC, \u2014 Directive 1999/100/EC, \u2014 Directive 1999/102/EC, \u2014 Directive 2001/1/EC, \u2014 Directive 2001/100/EC, \u2014 Directive 2002/80/EC, \u2014 Directive 2003/76/EC, \u2014 Directive 2004/3/EC. 2. Annexes II and V of Commission Directive 89/491/EEC of 17 July 1989 adapting to technical progress Council Directives 70/157/EEC, 70/220/EEC, 72/245/EEC, 72/306/EEC, 80/1268/EEC and 80/1269/EEC relating to motor vehicles (25) shall be deleted with effect from 2 January 2013. 3. References made to the repealed Directives shall be construed as being made to this Regulation. 4. Member States shall repeal their implementing legislation adopted under the Directives referred to in paragraph 1 with effect from 2 January 2013. Article 18 Entry into force 1. This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union. 2. This Regulation shall apply from 3 January 2009, with the exception of Articles 10(1) and 12 which shall apply from 2 July 2007. 3. The amendments or implementing measures referred to in Article 5(3) and Article 14(6) shall be adopted by 2 July 2008. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 20 June 2007. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President G. GLOSER (1) OJ C 318, 23.12.2006, p. 62. (2) Opinion of the European Parliament of 13 December 2006 (not yet published in the Official Journal) and Council Decision of 30 May 2007. (3) OJ L 42, 23.2.1970, p. 1. Directive as last amended by Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81). (4) Organisation for the Advancement of Structured Information Standards. (5) Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States on measures to be taken against air pollution by emissions from motor vehicles (OJ L 76, 6.4.1970, p. 1). Directive as last amended by Commission Directive 2003/76/EC (OJ L 206, 15.8.2003, p. 29). (6) Council Directive 72/306/EEC of 2 August 1972 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in vehicles (OJ L 190, 20.8.1972, p. 1). Directive as last amended by Commission Directive 2005/21/EC (OJ L 61, 8.3.2005, p. 25). (7) Council Directive 74/290/EEC of 28 May 1974 adapting to technical progress Council Directive No 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by gases from positive-ignition engines of motor vehicles (OJ L 159, 15.6.1974, p. 61). Directive as amended by Directive 2006/101/EC (OJ L 363, 20.12.2006, p. 238). (8) Council Directive 80/1268/EEC of 16 December 1980 relating to the carbon dioxide emissions and the fuel consumption of motor vehicles (OJ L 375, 31.12.1980, p. 36). Directive as last amended by Directive 2004/3/EC of the European Parliament and of the Council (OJ L 49, 19.2.2004, p. 36). (9) Council Directive 83/351/EEC of 16 June 1983 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by gases from positive-ignition engines of motor vehicles (OJ L 197, 20.7.1983, p. 1). (10) Council Directive 88/76/EEC of 3 December 1987 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by gases from the engines of motor vehicles (OJ L 36, 9.2.1988, p. 1). (11) Council Directive 88/436/EEC of 16 June 1988 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by gases from engines of motor vehicles (Restriction of particulate pollutant emissions from diesel engines) (OJ L 214, 6.8.1988, p. 1). (12) Council Directive 89/458/EEC of 18 July 1989 amending with regard to European emission standards for cars below 1,4 litres Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (OJ L 226, 3.8.1989, p. 1). (13) Council Directive 91/441/EEC of 26 June 1991 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (OJ L 242, 30.8.1991, p. 1). (14) Council Directive 93/59/EEC of 28 June 1993 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (OJ L 186, 28.7.1993, p. 21). (15) Directive 94/12/EC of the European Parliament and the Council of 23 March 1994 relating to measures to be taken against air pollution by emissions from motor vehicles (OJ L 100, 19.4.1994, p. 42). (16) Directive 96/69/EC of the European Parliament and of the Council of 8 October 1996 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (OJ L 282, 1.11.1996, p. 64). (17) Directive 98/69/EC of the European Parliament and of the Council of 13 October 1998 relating to measures to be taken against air pollution by emissions from motor vehicles (OJ L 350, 28.12.1998, p. 1). (18) Directive 2001/1/EC of the European Parliament and of the Council of 22 January 2001 amending Council Directive 70/220/EEC concerning measures to be taken against air pollution by emissions from motor vehicles (OJ L 35, 6.2.2001, p. 34). (19) Directive 2001/100/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 70/220/EEC on the approximation of the laws of the Member States on measures to be taken against air pollution by emissions from motor vehicles (OJ L 16, 18.1.2002, p. 32). (20) Directive 2004/3/EC of the European Parliament and of the Council of 11 February 2004 amending Council Directives 70/156/EEC and 80/1268/EEC as regards the measurement of carbon dioxide emissions and fuel consumption of N1 vehicles (OJ L 49, 19.2.2004, p. 36). (21) OJ L 275, 20.10.2005, p. 1. Directive as last amended by Commission Directive 2006/51/EC (OJ L 152, 7.6.2006, p. 11). (22) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (23) The \u2018OASIS format\u2019 refers to the technical specifications of OASIS Document SC2-D5, Format of Automotive Repair Information, version 1.0, 28 May 2003 (available at: http://www.oasis-open.org/committees/download.php/2412/Draft%20Committee%20Specification.pdf) and of Sections 3.2, 3.5, 3.6, 3.7 and 3.8 of OASIS Document SC1-D2, Autorepair Requirements Specification, version 6.1, dated 10.1.2003 (available at: http://lists.oasis-open.org/archives/autorepair/200302/pdf00005.pdf), using only open text and graphic formats. (24) OJ L 171, 29.6.2007, p. 1.\u2019 (25) OJ L 238, 15.8.1989, p. 43. ANNEX I EMISSION LIMITS Table 1 Euro 5 emission limits Reference mass (RM) (kg) Limit values Mass of carbon monoxide (CO) Mass of total hydrocarbons (THC) Mass of non-methane hydrocarbons (NMHC) Mass of oxides of nitrogen (NOx) Combined mass of total hydrocarbons and oxides of nitrogen (THC + NOx) Mass of particulate matter (PM) Number of particles (1) (P) L1 (mg/km) L2 (mg/km) L3 (mg/km) L4 (mg/km) L2 + L4 (mg/km) L5 (mg/km) L6 (#/km) Category Class PI CI PI CI PI CI PI CI PI CI PI (2) CI PI CI M \u2014 All 1 000 500 100 \u2014 68 \u2014 60 180 \u2014 230 5,0 5,0 N1 I RM \u2264 1 305 1 000 500 100 \u2014 68 \u2014 60 180 \u2014 230 5,0 5,0 II 1 305 < RM \u2264 1 760 1 810 630 130 \u2014 90 \u2014 75 235 \u2014 295 5,0 5,0 III 1 760 < RM 2 270 740 160 \u2014 108 \u2014 82 280 \u2014 350 5,0 5,0 N2 2 270 740 160 \u2014 108 \u2014 82 280 \u2014 350 5,0 5,0 Key: PI = Positive ignition, CI = Compression ignition Table 2 Euro 6 emission limits Reference mass (RM) (kg) Limit values Mass of carbon monoxide (CO) Mass of total hydrocarbons (THC) Mass of non-methane hydrocarbons (NMHC) Mass of oxides of nitrogen (NOx) Combined mass of total hydrocarbons and oxides of nitrogen (THC + NOx) Mass of particulate matter (PM) Number of particles (3) (P) L1 (mg/km) L2 (mg/km) L3 (mg/km) L4 (mg/km) L2 + L4 (mg/km) L5 (mg/km) L6 (#/km) Category Class PI CI PI CI PI CI PI CI PI CI PI (4) CI PI CI M \u2014 All 1 000 500 100 \u2014 68 \u2014 60 80 \u2014 170 5,0 5,0 N1 I RM \u2264 1 305 1 000 500 100 \u2014 68 \u2014 60 80 \u2014 170 5,0 5,0 II 1 305 < RM \u2264 1 760 1 810 630 130 \u2014 90 \u2014 75 105 \u2014 195 5,0 5,0 III 1 760 < RM 2 270 740 160 \u2014 108 \u2014 82 125 \u2014 215 5,0 5,0 N2 2 270 740 160 \u2014 108 \u2014 82 125 \u2014 215 5,0 5,0 Key: PI = Positive ignition, CI = Compression ignition Table 3 Emission limit for the evaporative emissions test Mass of Evaporative Emission (g/test) 2,0 Table 4 Emission limit for the carbon monoxide and hydrocarbon tailpipe emissions after a cold start test Test temperature 266 K (\u20137 \u00b0C) Vehicle Category Class Mass of carbon monoxide (CO) L1 (g/km) Mass of hydrocarbons (HC) L2 (g/km) M \u2014 15 1,8 N1 I 15 1,8 II 24 2,7 III 30 3,2 N2 30 3,2 (1) A number standard is to be defined as soon as possible and at the latest upon entry into force of Euro 6. (2) Positive ignition particulate mass standards apply only to vehicles with direct injection engines. (3) A number standard is to be defined for this stage. (4) Positive ignition particulate mass standards apply only to vehicles with direct injection engines. ANNEX II Amendments to Directive 70/156/EEC Directive 70/156/EEC is hereby amended as follows: 1. in Article 2 the following sentence shall be added after the last indent: \u2018If reference is made in this Directive to a separate Directive or Regulation it shall also include their implementing acts.\u2019; 2. the words \u2018or Regulation\u2019 shall be added after the words \u2018separate Directive\u2019 in the following provisions: Article 2, first indent; Article 2, ninth indent; Article 2, tenth indent; Article 2, fourteenth indent; Article 3(1); Article 3(4); Article 4(1)(c); Article 4(1)(d); Article 5(5); Article 6(3); Article 7(2); Article 13(4); Article 13(5); Annex I, first subparagraph; Annex III, Part III; Annex IV, Part II, first paragraph; Annex V Section 1(a); Annex V Section 1(b); Annex V Section 1(c); Annex VI, Side 2 of EC vehicle type-approval certificate; Annex VII(1), Section 4; Annex VII, footnote (1); Annex X, Section 2.1; Annex X, Section 3.3; Annex XI, Appendix 4, Meaning of letters: X; Annex XII, Section B(2); Annex XIV, Section 2(a); Annex XIV, Section 2(c); Annex XIV, Section 2(d); 3. the words \u2018or Regulations\u2019 shall be added after the words \u2018separate Directives\u2019 in the following provisions: Article 2, eight indent; Article 3(1); Article 3(2); Article 4(1)(a) first and second indents; Article 4(1)(b); Article 4(3); Article 5(4) third subparagraph; Article 5(6); Article 8(2); Article 8(2)(c); Article 9(2); Article 10(2); Article 11(1); Article 13(2); Article 14(1)(i); List of Annexes: title of Annex XIII; Annex I, first subparagraph; Annex IV, Part I, first and second lines; Annex IV, Part II, footnote (1) to the table; Annex V Section 1(b); Annex V Section 3; Annex V Section 3(a); Annex V Section 3(b); Annex VI, points 1 and 2; Annex VI, Side 2 of EC vehicle type-approval certificate; Annex X, Section 2.2; Annex X, Section 2.3.5; Annex X, Section 3.5; Annex XII, title; Annex XIV, Section 1.1; Annex XIV, Section 2(c); 4. the words \u2018or Regulation\u2019 shall be added after the word \u2018Directive\u2019 in the following provisions: Article 5(3) third subparagraph; Annex IV, Part I, footnote X to the table; Annex VI, Side 2 of EC vehicle type-approval certificate the heading of the tables; Annex VII(1) Section 2; Annex VII(1) Section 3; Annex VII(1) Section 4; Annex VIII, Sections 1, 2, 2.1, 2.2, and 3; Annex IX, Side 2 for complete or completed vehicles of category M1 points 45, 46.1 and 46.2; Annex IX, Side 2 for complete or completed vehicles of categories M2 and M3 points 45 and 46.1; Annex IX, Side 2 for complete or completed vehicles of categories N1, N2 and N3 points 45 and 46.1; Annex IX, Side 2 for incomplete vehicles of category M1 points 45 and 46.1; Annex IX, Side 2 for incomplete vehicles of categories M2 and M3 points 45 and 46.1; Annex IX, Side 2 for incomplete vehicles of categories N1, N2 and N3 points 45 and 46.1; Annex X, footnote 2; Annex X Section 1.2.2; Annex XI, Appendix 4, Meaning of letters: N/A; Annex XV, the heading of the table; The words \u2018or Regulations\u2019 shall be added after the word \u2018Directives\u2019 in the following provisions: Annex IX, Side 2 for complete or completed vehicles of category M1; Annex IX, Side 2 for complete or completed vehicles of categories M2 and M3; Annex IX, Side 2 for complete or completed vehicles of categories N1, N2 and N3; Annex IX, Side 2 for incomplete vehicles of category M1; Annex IX, Side 2 for incomplete vehicles of categories M2 and M3; Annex IX, Side 2 for incomplete vehicles of categories N1, N2 and N3; Annex XV; 5. in Article 8(2)(c) the words \u2018or Regulation(s)\u2019 shall be added after the word \u2018Directive(s)\u2019; 6. in Annex IV, part I, the heading of the table and point 2 shall be replaced by the following: \u2018Subject Directive/Regulation number Official Journal reference Applicability M1 M2 M3 N1 N2 N3 O1 O2 O3 O4 2. Emissions/Access to information \u2026/\u2026/EC (EC) No \u2026/\u2026 L \u2026, \u2026, p. \u2026 X (1) X (1) X (1) X (1) 7. in Annex IV, part I, points 11 and 39 shall be deleted; 8. in Annex VII(4) the words \u2018or Regulation\u2019 shall be added after the words \u2018in the case of a Directive\u2019; 9. in Annex VII(5) the words \u2018or Regulation\u2019 shall be added after the words \u2018the latest Directive\u2019; 10. in Annex XI, Appendix 1, the heading of the table and point 2 shall be replaced by the following: \u2018Item Subject Directive/Regulation number M1 \u2264 2 500 (1) kg M1 > 2 500 (1) kg M2 M3 2 Emissions/Access to information \u2026/\u2026/EC (EC) No \u2026/\u2026 Q G + Q G + Q\u2019 11. in Annex XI, Appendix 1, points 11 and 39 shall be deleted; 12. in Annex XI, Appendix 2, the heading of the table and point 2 shall be replaced by the following: \u2018Item Subject Directive/Regulation number M1 M2 M3 N1 N2 N3 O1 O2 O3 O4 2 Emissions/Access to information \u2026/\u2026/EC (EC) No \u2026/\u2026 A A A A\u2019 13. in Annex XI, Appendix 2, points 11 and 39 shall be deleted; 14. in Annex XI, Appendix 3, the heading of the table and point 2 shall be replaced by the following: \u2018Item Subject Directive/Regulation number M2 M3 N1 N2 N3 O1 O2 O3 O4 2 Emissions/Access to information \u2026/\u2026/EC (EC) No \u2026/\u2026 Q Q Q\u2019 15. in Annex XI, Appendix 3, point 11 shall be deleted; 16. in Annex XI, Appendix 4, the heading of the table and point 2 shall be replaced by the following: \u2018Item Subject Directive/Regulation number Mobile crane of category N 2 Emissions/Access to information \u2026/\u2026/EC (EC) No \u2026/\u2026 N/A\u2019 17. in Annex XI, Appendix 4, point 11 shall be deleted. (1) For vehicles with a reference mass not exceeding 2 610 kg. At the manufacturer's request may apply to vehicles with a reference mass not exceeding 2 840 kg.\u2019;", "summary": "Reducing pollution from light motor vehicles Reducing pollution from light motor vehicles SUMMARY OF: Regulation (EC) No 715/2007 \u2014 type-approval of light passenger and commercial vehicles with respect to emissions (Euro 5 and Euro 6) and access to vehicle repair and maintenance information WHAT IS THE AIM OF THE REGULATION? Regulation (EC) No 715/2007: sets harmonised rules for emission type-approval of cars and light commercial vehicles, known collectively as light-duty vehicles; covers replacement, pollution control devices*, and sets out rules for their type-approval; has been amended several times, most recently by Regulation (EU) 2018/858. Regulation (EU) 2018/858: overhauls the EU\u2019s rules on vehicle type-approval; introduces more robust testing methods with respect to pollutant emissions; and repeals Directive 2007/46/EC on EU type-approval for vehicles from 31 August 2020. KEY POINTS The legislation applies to light-duty vehicles less than 2.6 tonnes. Manufacturers must: design, construct and assemble components so that the vehicle complies with the legislation; prove that all new vehicles and new pollution control devices comply with the legislation and can meet the emission limits during a vehicle\u2019s normal life under normal conditions of use on the road; ensure that pollution control devices can last 160,000 km; vehicles emissions can be checked after 5 years or 100,000 km, whichever is sooner; provide buyers with carbon dioxide emissions and fuel consumption figures; not use defeat devices that reduce the effectiveness of emission control systems, except under strict conditions \u2014 such as to protect an engine against damage or accident; (until 1 September 2020) make available on websites unrestricted and standardised access to vehicle repair and maintenance information for independent garages. This should include items like service handbooks and technical manuals. They may charge a reasonable fee. These requirements are replaced by those in Regulation (EU) 2018/858 on 1 September 2020. National authorities must: give EU type-approval* to new vehicles that comply with the legislation; refuse to grant approval to vehicles that do not meet the emissions standards, within the authorised deadlines relating to each vehicle category; allow the registration of vehicles complying with this regulation; ban the sale or installation of pollution control devices that do not meet the EU standards; ensure penalties exist for manufacturers that falsify declarations or results, withhold data, or make use of defeat devices. The Commission keeps under regular review the procedures, tests, requirements and emission limits set out in the legislation and regularly updates them in implementing legislation. FROM WHEN DOES THE REGULATION APPLY? It has applied since 3 January 2009. BACKGROUND For more information, see: Emissions in the automotive sector (European Commission) Road transport: Reducing CO2 emissions from vehicles (European Commission). KEY TERMS Pollution control device: mechanism or equipment that removes pollutants, from car exhaust fumes for example, which otherwise would be released into the atmosphere. Type approval: the procedure by which a product is certified to meet a minimum set of regulatory and technical requirements. MAIN DOCUMENT Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, pp. 1-16) Successive amendments to Regulation (EC) No 715/2007 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, pp. 1-218) Commission Regulation (EU) 2017/1151 of 1 June 2017 supplementing Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information, amending Directive 2007/46/EC of the European Parliament and of the Council, Commission Regulation (EC) No 692/2008 and Commission Regulation (EU) No 1230/2012 and repealing Commission Regulation (EC) No 692/2008 (OJ L 175, 7.7.2017, pp. 1-643) See consolidated version. Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, pp. 1-160) See consolidated version. last update 08.10.2019"}
{"article": "31.12.2008 EN Official Journal of the European Union L 354/1 REGULATION (EC) No 1331/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests. (2) A high level of protection of human life and health should be assured in the pursuit of Community policies. (3) In order to protect human health, the safety of additives, enzymes and flavourings for use in foodstuffs for human consumption must be assessed before they are placed on the Community market. (4) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (3), Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (4) and Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (5) (hereinafter referred to as the sectoral food laws) lay down harmonised criteria and requirements concerning the assessment and authorisation of these substances. (5) It is envisaged, in particular, that food additives, food enzymes and food flavourings, to the extent that the safety of food flavourings must be assessed in accordance with Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods], must not be placed on the market or used in foodstuffs for human consumption, in accordance with the conditions laid down in each sectoral food law, unless they are included on a Community list of authorised substances. (6) Ensuring transparency in the production and handling of food is absolutely crucial in order to maintain consumer confidence. (7) In this context, it appears appropriate to establish for these three categories of substances a common Community assessment and authorisation procedure that is effective, time-limited and transparent, so as to facilitate their free movement within the Community market. (8) This common procedure must be founded on the principles of good administration and legal certainty and must be implemented in compliance with those principles. (9) This Regulation will thus complete the regulatory framework concerning the authorisation of the substances by laying down the various stages of the procedure, the deadlines for those stages, the role of the parties involved and the principles that apply. Nevertheless, for some aspects of the procedure, it is necessary to take the specific characteristics of each sectoral food law into consideration. (10) The deadlines laid down in the procedure take into account the time needed to consider the different criteria set in each sectoral food law, as well as allowing adequate time for consultation when preparing the draft measures. In particular, the nine-months deadline for the Commission to present a draft regulation updating the Community list should not preclude the possibility of this being done within a shorter period. (11) Upon receipt of an application the Commission should initiate the procedure and where necessary seek the opinion of the European Food Safety Authority (hereinafter referred to as the Authority) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (6) as soon as possible after the validity and applicability of the application have been assessed. (12) In accordance with the framework for risk assessment in matters of food safety established by Regulation (EC) No 178/2002, the authorisation to place substances on the market must be preceded by an independent scientific assessment, of the highest possible standard, of the risks that they pose to human health. This assessment, which must be carried out under the responsibility of the Authority, must be followed by a risk management decision taken by the Commission under a regulatory procedure that ensures close cooperation between the Commission and the Member States. (13) The authorisation to place substances on the market should be granted pursuant to this Regulation provided that the criteria for authorisation laid down under the sectoral food laws are satisfied. (14) It is recognised that, in some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account, including societal, economic, traditional, ethical and environmental factors and the feasibility of controls. (15) In order to ensure that both business operators in the sectors concerned and the public are kept informed of the authorisations in force, the authorised substances should be included on a Community list created, maintained and published by the Commission. (16) Where appropriate and under certain circumstances, the specific sectoral food law may provide for protection of scientific data and other information submitted by the applicant for a certain period of time. In this case, the sectoral food law should lay down the conditions under which these data may not be used for the benefit of another applicant. (17) Networking between the Authority and the Member States\u2019 organisations operating in the fields within the Authority\u2019s mission is one of the basic principles of the Authority\u2019s operation. In consequence, in preparing its opinion, the Authority may use the network made available to it by Article 36 of Regulation (EC) No 178/2002 and by Commission Regulation (EC) No 2230/2004 (7). (18) The common authorisation procedure for the substances must fulfil transparency and public information requirements while guaranteeing the right of applicants to preserve the confidentiality of certain information. (19) Protecting the confidentiality of certain aspects of an application should be maintained as a consideration in order to protect the competitive position of an applicant. However, information relating to the safety of a substance, including, but not limited to, toxicological studies, other safety studies and raw data as such, should under no circumstances be confidential. (20) Pursuant to Regulation (EC) No 178/2002, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (8) applies to documents held by the Authority. (21) Regulation (EC) No 178/2002 establishes procedures for taking emergency measures in relation to foodstuffs of Community origin or imported from third countries. It authorises the Commission to adopt such measures in situations where foodstuffs are likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned. (22) In the interests of efficiency and legislative simplification, there should be a medium-term examination of the question whether to extend the scope of the common procedure to other legislation in the area of food. (23) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States on account of differences between national laws and provisions and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (24) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9). (25) In particular the Commission should be empowered to update the Community lists. Since those measures are of general scope and are designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (26) On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the addition of substances to the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists. (27) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the removal of a substance from the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PRINCIPLES Article 1 Subject matter and scope 1. This Regulation lays down a common procedure for the assessment and authorisation (hereinafter referred to as the common procedure) of food additives, food enzymes, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs (hereinafter referred to as the substances), which contributes to the free movement of food within the Community and to a high level of protection of human health and to a high level of consumer protection, including the protection of consumer interests. This Regulation shall not apply to smoke flavourings falling within the scope of Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (10). 2. The common procedure shall lay down the procedural arrangements for updating the lists of substances the marketing of which is authorised in the Community pursuant to Regulation (EC) No 1333/2008 [on food additives], Regulation (EC) No 1332/2008 [on food enzymes] and Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods] (hereinafter referred to as the sectoral food laws). 3. The criteria according to which substances can be included on the Community list provided for in Article 2, the content of the regulation referred to in Article 7 and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law. Article 2 Community list of substances 1. Under each sectoral food law, substances that have been authorised to be placed on the Community market shall be included on a list the content of which is determined by the said law (hereinafter referred to as the Community list). The Community list shall be updated by the Commission. It shall be published in the Official Journal of the European Union. 2. \u2018Updating the Community list\u2019 means: (a) adding a substance to the Community list; (b) removing a substance from the Community list; (c) adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community list. CHAPTER II COMMON PROCEDURE Article 3 Main stages of the common procedure 1. The common procedure for updating the Community list may be started either on the initiative of the Commission or following an application. Applications may be made by a Member State or by an interested party, who may represent several interested parties, in accordance with the conditions provided for by the implementing measures referred to in Article 9(1)(a) (hereinafter referred to as the applicant). Applications shall be sent to the Commission. 2. The Commission shall seek the opinion of the European Food Safety Authority (hereinafter referred to as the Authority), to be given in accordance with Article 5. However, for the updates referred to in Article 2(2)(b) and (c), the Commission shall not be required to seek the opinion of the Authority if the updates in question are not liable to have an effect on human health. 3. The common procedure shall end with the adoption by the Commission of a regulation implementing the update, in accordance with Article 7. 4. By way of derogation from paragraph 3, the Commission may end the common procedure and decide not to proceed with a planned update, at any stage of the procedure, if it judges that such an update is not justified. Where applicable, it shall take account of the opinion of the Authority, the views of Member States, any relevant provisions of Community law and any other legitimate factors relevant to the matter under consideration. In such cases, where applicable, the Commission shall inform the applicant and the Member States directly, indicating in its letter the reasons for not considering the update justified. Article 4 Initiating the procedure 1. On receipt of an application to update the Community list, the Commission: (a) shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it; (b) where applicable, shall as soon as possible notify the Authority of the application and request its opinion in accordance with Article 3(2). The application shall be made available to the Member States by the Commission. 2. Where it starts the procedure on its own initiative, the Commission shall inform the Member States and, where applicable, request the opinion of the Authority. Article 5 Opinion of the Authority 1. The Authority shall give its opinion within nine months of receipt of a valid application. 2. The Authority shall forward its opinion to the Commission, the Member States and, where applicable, the applicant. Article 6 Additional information concerning risk assessment 1. In duly justified cases where the Authority requests additional information from applicants, the period referred to in Article 5(1) may be extended. After consulting the applicant, the Authority shall lay down a period within which this information can be provided and shall inform the Commission of the additional period needed. If the Commission does not object within eight working days of being informed by the Authority, the period referred to in Article 5(1) shall be automatically extended by the additional period. The Commission shall inform the Member States of the extension. 2. If the additional information is not sent to the Authority within the additional period referred to in paragraph 1, the Authority shall finalise its opinion on the basis of the information already provided. 3. Where applicants submit additional information on their own initiative, they shall send it to the Authority and to the Commission. In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10. 4. The additional information shall be made available to the Member States and the Commission by the Authority. Article 7 Updating the Community list 1. Within nine months of the Authority giving its opinion, the Commission shall submit to the Committee referred to in Article 14(1) a draft regulation updating the Community list, taking account of the opinion of the Authority, any relevant provisions of Community law and any other legitimate factors relevant to the matter under consideration. In those cases where an opinion of the Authority has not been requested, the nine-month period shall start from the date the Commission receives a valid application. 2. In the Regulation updating the Community list, the considerations on which it is based shall be explained. 3. Where the draft regulation is not in accordance with the opinion of the Authority, the Commission shall explain the reasons for its decision. 4. The measures, designed to amend non-essential elements of each sectoral food law, relating to the removal of a substance from the Community list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3). 5. On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it, relating to the addition of a substance to the Community list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of the substance on the Community list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(4). 6. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(5) for the removal of a substance from the Community list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community list. Article 8 Additional information concerning risk management 1. Where the Commission requests additional information from applicants on matters concerning risk management, it shall determine, together with the applicant, a period within which that information can be provided. In such cases, the period referred to in Article 7 may be extended accordingly. The Commission shall inform the Member States of the extension and shall make the additional information available to the Member States once it has been provided. 2. If the additional information is not sent within the additional period referred to in paragraph 1, the Commission shall act on the basis of the information already provided. CHAPTER III MISCELLANEOUS PROVISIONS Article 9 Implementing measures 1. In accordance with the regulatory procedure referred to in Article 14(2), within a period of no longer than 24 months from the adoption of each sectoral food law, the implementing measures for this Regulation shall be adopted by the Commission, and shall concern in particular: (a) the content, drafting and presentation of the application referred to in Article 4(1); (b) the arrangements for checking the validity of applications; (c) the type of information that must be included in the opinion of the Authority referred to in Article 5. 2. With a view to the adoption of the implementing measures referred to in paragraph 1(a), the Commission shall consult the Authority, which, within six months of the date of entry into force of each sectoral food law, shall present it with a proposal concerning the data required for risk assessment of the substances concerned. Article 10 Extension of time periods In exceptional circumstances, the periods referred to in Article 5(1) and Article 7 may be extended by the Commission on its own initiative or, where applicable, at the Authority\u2019s request, if the nature of the matter in question so justifies, without prejudice to Article 6(1) and Article 8(1). In such cases the Commission shall, where appropriate, inform the applicant and the Member States of the extension and the reasons for it. Article 11 Transparency The Authority shall ensure the transparency of its activities in accordance with Article 38 of Regulation (EC) No 178/2002. In particular, it shall make its opinions public without delay. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1). Article 12 Confidentiality 1. Among the information provided by applicants, confidential treatment may be given to information the disclosure of which might significantly harm their competitive position. Information relating to the following shall not, in any circumstances, be regarded as confidential: (a) the name and address of the applicant; (b) the name and a clear description of the substance; (c) the justification for the use of the substance in or on specific foodstuffs or food categories; (d) information that is relevant to the assessment of the safety of the substance; (e) where applicable, the analysis method(s). 2. For the purposes of implementing paragraph 1, applicants shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification must be given in such cases. 3. The Commission shall decide after consulting with the applicants which information can remain confidential and shall notify applicants and the Member States accordingly. 4. After being made aware of the Commission\u2019s position, applicants shall have three weeks in which to withdraw their application so as to preserve the confidentiality of the information provided. Confidentiality shall be preserved until this period expires. 5. The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001, take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment. 6. If an applicant withdraws, or has withdrawn, its application, the Commission, the Authority and the Member States shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the Commission and the applicant. 7. The implementation of paragraphs 1 to 6 shall not affect the circulation of information between the Commission, the Authority and the Member States. Article 13 Emergencies In the event of an emergency concerning a substance on the Community list, particularly in the light of an opinion of the Authority, measures shall be adopted in accordance with the procedures referred to in Articles 53 and 54 of Regulation (EC) No 178/2002. Article 14 Committee 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58 of Regulation (EC) No 178/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e) of Decision 1999/468/EC shall be two months, two months and four months respectively. 5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 15 Competent authorities of the Member States Not later than six months after the entry into force of each sectoral food law, Member States shall forward to the Commission and to the Authority, in relation to each sectoral food law, the name and address of the national competent authority for the purposes of the common procedure, as well as a contact point therein. CHAPTER IV FINAL PROVISION Article 16 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. For each sectoral food law, it shall apply from the date of application of the measures referred to in Article 9(1). Article 9 shall apply from 20 January 2009. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 December 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President B. LE MAIRE (1) OJ C 168, 20.7.2007, p. 34. (2) Opinion of the European Parliament of 10 July 2007 (OJ C 175 E, 10.7.2008, p. 134), Council Common Position of 10 March 2008 (OJ C 111 E, 6.5.2008, p. 1), Position of the European Parliament of 8 July 2008 (not yet published in the Official Journal) and Council Decision of 18 November 2008. (3) See page 16 of this Official Journal. (4) See page 7 of this Official Journal. (5) See page 34 of this Official Journal. (6) OJ L 31, 1.2.2002, p. 1. (7) Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority\u2019s mission (OJ L 379, 24.12.2004, p. 64). (8) OJ L 145, 31.5.2001, p. 43. (9) OJ L 184, 17.7.1999, p. 23. (10) OJ L 309, 26.11.2003, p. 1.", "summary": "Authorisation procedure for additives, enzymes and flavourings Authorisation procedure for additives, enzymes and flavourings SUMMARY OF: Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain WHAT IS THE AIM OF THE REGULATIONS? Regulation (EC) No 1331/2008 introduces a harmonised, effective, fast and transparent authorisation procedure for food additives, food enzymes and food flavourings in the EU, aiming to facilitate the free movement of food while assuring consumer health. It does not apply to smoke flavourings. The procedure is based on a risk assessment by the European Food Safety Authority (EFSA), set up under Regulation (EC) No 178/2002, and leads to the updating of a Community (EU) list for each of the 3 categories of substance. Amending Regulation (EU) 2019/1381 introduces new rules on transparency and confidentiality in risk assessment. KEY POINTS Common procedure Only substances authorised for the EU market are on the EU list, which is updated on the initiative of the European Commission, of an EU country or of another interested party through an official application. The Commission forwards applications for substances to be included on the list to EFSA for risk assessment (mandatory where there could be an effect on human health). EFSA must normally respond within 9 months. In justified cases where EFSA requests additional information from applicants, the period may be extended. EFSA makes public, under the 2019 amendment, any additional information supplied by the applicant. The Commission issues a draft regulation updating the EU list within 9 months of receiving EFSA\u2019s opinion. The process may be halted by the Commission at any time. In urgent cases, there are special arrangements for adding, removing or changing conditions for substances on the list. The Commission is assisted by the Standing Committee on Plants, Animals, Food and Feed in updating the EU list. Implementation The Commission had 2 years from the adoption of the regulations on additives, enzymes and flavourings, after consultation with EFSA on risk assessment, to finalise how it would deal with applications, including: content, drafting and presentation; checking the validity of applications; the type of information to be included. Transparency Under Regulation (EC) No 1331/2008, EFSA ensures the transparency of its activities in accordance with Regulation (EC) No 178/2002. Amending Regulation (EU) 2019/1381 introduces new rules on transparency requiring EFSA, where the Commission requests its opinion, to make the application public without delay, including relevant supporting information and additional information supplied by the applicant, as well as its scientific opinions. EFSA makes public any request for its opinion as well as any extension of time limits for its work. Confidentiality Under Regulation (EC) No 1331/2008, applicants may request certain parts of their applications to be treated as confidential, along with verifiable justification. Amending Regulation (EU) 2019/1381 allows EFSA to also grant confidentiality for the following, where applicable, if the applicant demonstrates that disclosure could significantly harm its interests (except for information relevant to the assessment of safety): information provided on material used to manufacture the substance concerned;information on the materials or products in which the applicant intends to use the substance;detailed analytical information on the variability and stability of individual production batches. Emergencies If there is an emergency connected with a substance on the list, the Commission initiates EFSA food safety procedures. Companion legislation The 2008 regulation was adopted at the same time as the following companion legislation, which goes into more detail on the 3 categories: Regulation (EC) No 1332/2008 on food enzymes (see summary); Regulation (EC) No 1333/2008 on food additives (see summary); Regulation (EC) No 1334/2008 on flavourings (see summary). FROM WHEN DO THE REGULATIONS APPLY? Regulation (EC) No 1331/2008 has applied since 20 January 2009. Amending Regulation (EU) 2019/1381 applies from 27 March 2021. BACKGROUND For more information, see: European Food Safety Authority Common authorisation procedure (European Commission). MAIN DOCUMENTS Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, pp. 1-6) Successive amendments to Regulation (EU) No 1331/2008 have been incorporated in the basic text. This consolidated version is of documentary value only. Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, pp. 1-28) RELATED DOCUMENTS Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, pp. 7-15) See consolidated version. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, pp. 16-33) See consolidated version. Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, pp. 34-50) See consolidated version. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, pp. 1-24) See consolidated version. last update 01.10.2020"}
{"article": "13.8.2008 EN Official Journal of the European Union L 218/30 REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 133 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) It is necessary to ensure that products benefiting from the free movement of goods within the Community fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety at the workplace, protection of consumers, protection of the environment and security, while ensuring that the free movement of products is not restricted to any extent greater than that which is allowed under Community harmonisation legislation or any other relevant Community rules. Provision should, therefore, be made for rules on accreditation, market surveillance, controls of products from third countries and the CE marking. (2) It is necessary to establish an overall framework of rules and principles in relation to accreditation and market surveillance. That framework should not affect the substantive rules of existing legislation setting out the provisions to be observed for the purpose of protecting public interests such as health, safety and protection of consumers and of the environment, but should aim at enhancing their operation. (3) This Regulation should be seen as complementary to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (3). (4) It is very difficult to adopt Community legislation for every product which exists or which may be developed; there is a need for a broad-based, legislative framework of a horizontal nature to deal with such products, to cover lacunae, in particular pending revision of existing specific legislation, and to complement provisions in existing or future specific legislation, in particular with a view to ensuring a high level of protection of health, safety, the environment and consumers, as required by Article 95 of the Treaty. (5) The framework for market surveillance established by this Regulation should complement and strengthen existing provisions in Community harmonisation legislation relating to market surveillance and the enforcement of such provisions. However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in other existing or future rules of Community harmonisation legislation. Examples can be found in the following sectors: drug precursors, medical devices, medicinal products for human and veterinary use, motor vehicles and aviation. The corresponding provisions of this Regulation should not therefore apply in the areas covered by such specific provisions. (6) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (4) established rules to ensure the safety of consumer products. Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive. (7) However, in order to achieve a higher level of safety for consumer products, the market surveillance mechanisms provided for in Directive 2001/95/EC should be reinforced as regards products presenting a serious risk, in accordance with the principles established by this Regulation. Directive 2001/95/EC should therefore be amended accordingly. (8) Accreditation is part of an overall system, including conformity assessment and market surveillance, designed to assess and ensure conformity with the applicable requirements. (9) The particular value of accreditation lies in the fact that it provides an authoritative statement of the technical competence of bodies whose task is to ensure conformity with the applicable requirements. (10) Accreditation, though so far not regulated at Community level, is carried out in all Member States. The lack of common rules for that activity has resulted in different approaches and differing systems throughout the Community, with the result that the degree of rigour applied in the performance of accreditation has varied between Member States. It is therefore necessary to develop a comprehensive framework for accreditation and to lay down at Community level the principles for its operation and organisation. (11) The establishment of a uniform national accreditation body should be without prejudice to the allocation of functions within Member States. (12) Where Community harmonisation legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation, as provided for in this Regulation, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Community the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means of carrying out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements. (13) A system of accreditation which functions by reference to binding rules helps to strengthen mutual confidence between Member States as regards the competence of conformity assessment bodies and consequently the certificates and test reports issued by them. It thereby enhances the principle of mutual recognition and therefore the provisions of this Regulation on accreditation should apply in relation to bodies carrying out conformity assessments in both the regulated and the non-regulated areas. The issue at stake is the quality of certificates and test reports irrespective of whether they fall within the regulated or the non-regulated area, and no distinction should therefore be made between those areas. (14) For the purposes of this Regulation, not-for-profit operation by a national accreditation body should be understood as an activity that is not intended to add any gain to the resources of the body's owners or members. While national accreditation bodies do not have the objective of maximising or distributing profits, they may provide services in return for payment, or receive income. Any excess revenue that results from such services may be used for investment to develop their activities further, as long as it is in line with their main activities. It should accordingly be emphasised that the primary objective of national accreditation bodies should be to support or engage actively in activities that are not intended to produce any gain. (15) Since the purpose of accreditation is to provide an authoritative statement of the competence of a body to perform conformity assessment activities, Member States should not maintain more than one national accreditation body and should ensure that that body is organised in such a way as to safeguard the objectivity and impartiality of its activities. Such national accreditation bodies should operate independently of commercial conformity assessment activities. It is therefore appropriate to provide that Member States ensure that, in the performance of their tasks, national accreditation bodies are deemed to exercise public authority, irrespective of their legal status. (16) For the assessment and continued monitoring of the competence of a conformity assessment body, it is essential to determine its technological knowledge and experience and its ability to carry out assessment. It is therefore necessary that the national accreditation body possess the relevant knowledge, competence and means for the proper performance of its tasks. (17) Accreditation should in principle be operated as a self-supporting activity. Member States should ensure that financial support exists for the fulfilment of special tasks. (18) In those cases where it is not economically meaningful or sustainable for a Member State to establish a national accreditation body, that Member State should have recourse to the national accreditation body of another Member State and should be encouraged to have such recourse to the fullest extent possible. (19) Competition between national accreditation bodies could lead to the commercialisation of their activity, which would be incompatible with their role as the last level of control in the conformity assessment chain. The objective of this Regulation is to ensure that, within the European Union, one accreditation certificate is sufficient for the whole territory of the Union, and to avoid multiple accreditation, which is added cost without added value. National accreditation bodies may find themselves in competition on the markets of third countries, but that must have no effect on their activities inside the Community, or on the cooperation and peer evaluation activities organised by the body recognised under this Regulation. (20) In order to avoid multiple accreditation, to enhance acceptance and recognition of accreditation certificates and to carry out effective monitoring of accredited conformity assessment bodies, conformity assessment bodies should request accreditation by the national accreditation body of the Member State in which they are established. Nevertheless, it is necessary to ensure that a conformity assessment body is able to request accreditation in another Member State in the event that there is no national accreditation body in its own Member State or where the national accreditation body is not competent to provide the accreditation services requested. In such cases, appropriate cooperation and exchange of information between national accreditation bodies should be established. (21) In order to ensure that national accreditation bodies fulfil the requirements and obligations provided for in this Regulation, it is important that Member States support the proper functioning of the accreditation system, monitor their national accreditation bodies regularly and take appropriate corrective measures within a reasonable timeframe where necessary. (22) In order to ensure the equivalence of the level of competence of conformity assessment bodies, to facilitate mutual recognition and to promote the overall acceptance of accreditation certificates and conformity assessment results issued by accredited bodies, it is necessary that national accreditation bodies operate a rigorous and transparent peer evaluation system and regularly undergo such evaluation. (23) This Regulation should provide for the recognition of a single organisation at European level in respect of certain functions in the field of accreditation. The European cooperation for Accreditation (the EA), whose main mission is to promote a transparent and quality-led system for the evaluation of the competence of conformity assessment bodies throughout Europe, manages a peer evaluation system among national accreditation bodies from the Member States and other European countries. That system has proved to be efficient and to provide mutual confidence. The EA should, therefore, be the first body recognised under this Regulation and Member States should ensure that their national accreditation bodies seek and maintain membership of the EA for as long as it is so recognised. At the same time, the possibility of changing the relevant body recognised under this Regulation should be provided for, in case there is a need for it in the future. (24) Effective cooperation among national accreditation bodies is essential for the proper implementation of peer evaluation and with regard to cross-border accreditation. In the interests of transparency, it is, therefore, necessary to provide for an obligation on national accreditation bodies to exchange information among themselves and to provide the national authorities and the Commission with relevant information. Updated and accurate information concerning the availability of accreditation activities operated by national accreditation bodies should also be made public and, therefore, accessible, in particular to conformity assessment bodies. (25) Sectoral accreditation schemes should cover the fields of activity where general requirements for the competence of conformity assessment bodies are not sufficient to ensure the necessary level of protection where specific detailed technology or health and safety-related requirements are imposed. Given the fact that the EA has at its disposal a broad range of technical expertise, it should be requested to develop such schemes, especially for areas covered by Community legislation. (26) For the purpose of ensuring the equivalent and consistent enforcement of Community harmonisation legislation, this Regulation introduces a Community market surveillance framework, defining minimum requirements against the background of the objectives to be achieved by Member States and a framework for administrative cooperation including the exchange of information among Member States. (27) In the case of economic operators in possession of test reports or certificates attesting conformity issued by an accredited conformity assessment body, where the relevant Community harmonisation legislation does not require such reports or certificates, market surveillance authorities should take due account of them when performing checks on product characteristics. (28) Cooperation between competent authorities at national level and across borders in exchanging information, investigating infringements and taking action to bring about their cessation, even before the placing on the market of dangerous products, by reinforcing measures to identify them, mainly in seaports, is essential to the protection of health and safety and to guaranteeing the smooth functioning of the internal market. National consumer protection authorities should cooperate, at national level, with national market surveillance authorities and should exchange information with them relating to products which they suspect present a risk. (29) Risk assessment should take all relevant data into account, including, where available, data on risks that have materialised with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned to alleviate the risks. (30) Situations of serious risk posed by a product require rapid intervention, which may entail the withdrawal of the product, its recall or the prohibition of its being made available on the market. In those situations it is necessary to have access to a system of rapid exchange of information between Member States and the Commission. The system provided for in Article 12 of Directive 2001/95/EC has proved its effectiveness and efficiency in the field of consumer products. To avoid unnecessary duplication, that system should be used for the purposes of this Regulation. Moreover, coherent market surveillance throughout the Community requires a comprehensive exchange of information on national activities in this context which goes beyond this system. (31) Information exchanged between competent authorities should be subject to the strictest guarantees of confidentiality and professional secrecy and be handled in accordance with rules on confidentiality pursuant to the applicable national law or, as regards the Commission, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (5), in order to ensure that investigations are not compromised and that the reputations of economic operators are not prejudiced. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (6) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (7) apply in the context of this Regulation. (32) Community harmonisation legislation provides for specific procedures establishing whether or not a national measure restricting the free movement of a product is justified (safeguard clause procedures). Those procedures apply following a rapid exchange of information on products presenting a serious risk. (33) Points of entry at the external borders are well placed to detect unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner even before they are placed on the market. An obligation on authorities in charge of the control of products entering the Community market to execute checks on an adequate scale can therefore contribute to a safer market place. In order to increase the effectiveness of such checks, those authorities should receive all the necessary information concerning dangerous non-conforming products from the market surveillance authorities well in advance. (34) Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (8) lays down rules regarding the suspension of the release of products by customs authorities and provides for further measures including the involvement of market surveillance authorities. It is therefore appropriate that those provisions, including the involvement of market surveillance authorities, be incorporated in this Regulation. (35) Experience has shown that products which are not released are often re-exported and subsequently enter the Community market at other points of entry, thus undermining the customs authorities' efforts. Market surveillance authorities should therefore be given the means of proceeding with the destruction of products if they deem it appropriate. (36) Within one year of the publication of this Regulation in the Official Journal of the European Union, the Commission should present an in-depth analysis in the realm of consumer safety markings, followed by legislative proposals where necessary. (37) The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking should be set out in this Regulation so as to make them immediately applicable and to simplify future legislation. (38) The CE marking should be the only marking of conformity indicating that a product is in conformity with Community harmonisation legislation. However, other markings may be used as long as they contribute to the improvement of consumer protection and are not covered by Community harmonisation legislation. (39) It is necessary for Member States to provide for appropriate means of redress in the competent courts and tribunals in respect of measures taken by the competent authorities which restrict the placing on the market of a product or which require its withdrawal or recall. (40) Member States may find it useful to establish cooperation with the stakeholders concerned, including sectoral professional organisations and consumer organisations, in order to take advantage of available market intelligence when establishing, implementing and updating market surveillance programmes. (41) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive and could be increased if the relevant economic operator has previously committed a similar infringement of the provisions of this Regulation. (42) In order to achieve the objectives of this Regulation, it is necessary for the Community to contribute to the financing of activities required to implement policies in the field of accreditation and market surveillance. Financing should be provided in the form of grants to the body recognised under this Regulation without a call for proposals, in the form of grants after a call for proposals, or by the award of contracts to that or to other bodies, depending on the nature of the activity to be financed and in accordance with Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (9) (the Financial Regulation). (43) For some specialised tasks, such as the production and revision of sectoral accreditation schemes, and for other tasks related to the verification of the technical competence and the facilities of laboratories and certification or inspection bodies, the EA should initially be eligible for Community financing, since it is well adapted to providing the necessary technical expertise in this respect. (44) Given the role of the body recognised under this Regulation in the peer evaluation of accreditation bodies and its ability to assist the Member States with the management of that peer evaluation, the Commission should be in a position to provide grants for the functioning of the secretariat of the body recognised under this Regulation, which should provide ongoing support for accreditation activities at Community level. (45) A partnership agreement should be signed, in accordance with the provisions of the Financial Regulation, between the Commission and the body recognised under this Regulation in order to fix the administrative and financial rules on the financing of accreditation activities. (46) In addition, financing should also be available to bodies other than the body recognised under this Regulation for other activities in the field of conformity assessment, metrology, accreditation and market surveillance, such as the drawing-up and updating of guidelines, inter-comparison activities linked to the operation of safeguard clauses, preliminary or ancillary activities in connection with the implementation of Community legislation in those areas and programmes of technical assistance and cooperation with third countries as well as the enhancement of policies in those areas at Community and international level. (47) This Regulation respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union. (48) Since the objective of this Regulation, namely to ensure that products on the market covered by Community legislation fulfil requirements providing a high level of protection of health and safety and other public interests while guaranteeing the functioning of the internal market by providing a framework for accreditation and market surveillance, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities. 2. This Regulation provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security. 3. This Regulation provides a framework for controls on products from third countries. 4. This Regulation lays down the general principles of the CE marking. Article 2 Definitions For the purposes of this Regulation the following definitions shall apply: 1. \u2018making available on the market\u2019 shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge; 2. \u2018placing on the market\u2019 shall mean the first making available of a product on the Community market; 3. \u2018manufacturer\u2019 shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark; 4. \u2018authorised representative\u2019 shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation; 5. \u2018importer\u2019 shall mean any natural or legal person established within the Community who places a product from a third country on the Community market; 6. \u2018distributor\u2019 shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; 7. \u2018economic operators\u2019 shall mean the manufacturer, the authorised representative, the importer and the distributor; 8. \u2018technical specification\u2019 shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service; 9. \u2018harmonised standard\u2019 shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (10) on the basis of a request made by the Commission in accordance with Article 6 of that Directive; 10. \u2018accreditation\u2019 shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity; 11. \u2018national accreditation body\u2019 shall mean the sole body in a Member State that performs accreditation with authority derived from the State; 12. \u2018conformity assessment\u2019 shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled; 13. \u2018conformity assessment body\u2019 shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection; 14. \u2018recall\u2019 shall mean any measure aimed at achieving the return of a product that has already been made available to the end user; 15. \u2018withdrawal\u2019 shall mean any measure aimed at preventing a product in the supply chain from being made available on the market; 16. \u2018peer evaluation\u2019 shall mean a process for the assessment of a national accreditation body by other national accreditation bodies, carried out in accordance with the requirements of this Regulation, and, where applicable, additional sectoral technical specifications; 17. \u2018market surveillance\u2019 shall mean the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; 18. \u2018market surveillance authority\u2019 shall mean an authority of a Member State responsible for carrying out market surveillance on its territory; 19. \u2018release for free circulation\u2019 shall mean the procedure laid down in Article 79 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (11); 20. \u2018CE marking\u2019 shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing; 21. \u2018Community harmonisation legislation\u2019 shall mean any Community legislation harmonising the conditions for the marketing of products. CHAPTER II ACCREDITATION Article 3 Scope This Chapter shall apply to accreditation, used on a compulsory or voluntary basis, relating to conformity assessment, whether that assessment is compulsory or not, and irrespective of the legal status of the body performing the accreditation. Article 4 General principles 1. Each Member State shall appoint a single national accreditation body. 2. Where a Member State considers that it is not economically meaningful or sustainable to have a national accreditation body or to provide certain accreditation services, it shall, as far as possible, have recourse to the national accreditation body of another Member State. 3. A Member State shall inform the Commission and the other Member States where, in accordance with paragraph 2, recourse is had to the national accreditation body of another Member State. 4. On the basis of the information referred to in paragraph 3 and Article 12, the Commission shall draw up and update a list of national accreditation bodies which it shall make publicly available. 5. Where accreditation is not operated directly by the public authorities themselves, a Member State shall entrust its national accreditation body with the operation of accreditation as a public authority activity and grant it formal recognition. 6. The responsibilities and tasks of the national accreditation body shall be clearly distinguished from those of other national authorities. 7. The national accreditation body shall operate on a not-for-profit basis. 8. The national accreditation body shall not offer or provide any activities or services that conformity assessment bodies provide, nor shall it provide consultancy services, own shares in or otherwise have a financial or managerial interest in a conformity assessment body. 9. Each Member State shall ensure that its national accreditation body has the appropriate financial and personnel resources for the proper performance of its tasks, including the fulfilment of special tasks, such as activities for European and international accreditation cooperation and activities that are required to support public policy and which are not self-financing. 10. The national accreditation body shall be a member of the body recognised under Article 14. 11. National accreditation bodies shall establish and maintain appropriate structures to ensure the effective and balanced involvement of all interested parties within both their organisations and the body recognised under Article 14. Article 5 Operation of accreditation 1. A national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect. 2. When a Member State decides not to use accreditation, it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Community harmonisation legislation in question. 3. National accreditation bodies shall monitor the conformity assessment bodies to which they have issued an accreditation certificate. 4. Where a national accreditation body ascertains that a conformity assessment body which has received an accreditation certificate is no longer competent to carry out a specific conformity assessment activity or has committed a serious breach of its obligations, that accreditation body shall take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate. 5. Member States shall establish procedures for the resolution of appeals, including, where appropriate, legal remedies against accreditation decisions or the absence thereof. Article 6 Principle of non-competition 1. National accreditation bodies shall not compete with conformity assessment bodies. 2. National accreditation bodies shall not compete with other national accreditation bodies. 3. National accreditation bodies shall be permitted to operate across national borders, within the territory of another Member State, either at the request of a conformity assessment body in the circumstances set out in Article 7(1), or, if they are asked to do so by a national accreditation body in accordance with Article 7(3), in cooperation with the national accreditation body of that Member State. Article 7 Cross-border accreditation 1. Where a conformity assessment body requests accreditation it shall do so with the national accreditation body of the Member State in which it is established or with the national accreditation body to which that Member State has had recourse in accordance with Article 4(2). However, a conformity assessment body may request accreditation by a national accreditation body other than those referred to in the first subparagraph in any one of the following situations: (a) where the Member State in which it is established has decided not to establish a national accreditation body and has not had recourse to the national accreditation body of another Member State in accordance with Article 4(2); (b) where the national accreditation bodies referred to in the first subparagraph do not perform accreditation in respect of the conformity assessment activities for which accreditation is sought; (c) where the national accreditation bodies referred to in the first subparagraph have not successfully undergone peer evaluation under Article 10 in respect of the conformity assessment activities for which accreditation is sought. 2. Where a national accreditation body receives a request pursuant to paragraph 1(b) or (c), it shall inform the national accreditation body of the Member State in which the requesting conformity assessment body is established. In such cases, the national accreditation body of the Member State in which the requesting conformity assessment body is established may participate as an observer. 3. A national accreditation body may request another national accreditation body to carry out part of the assessment activity. In such a case, the accreditation certificate shall be issued by the requesting body. Article 8 Requirements for national accreditation bodies A national accreditation body shall fulfil the following requirements: 1. it shall be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and to ensure that no conflicts of interest with conformity assessment bodies occur; 2. it shall be organised and operated so as to safeguard the objectivity and impartiality of its activities; 3. it shall ensure that each decision relating to the attestation of competence is taken by competent persons different from those who carried out the assessment; 4. it shall have adequate arrangements to safeguard the confidentiality of the information obtained; 5. it shall identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to relevant Community or national legislation and standards; 6. it shall set up the procedures necessary to ensure efficient management and appropriate internal controls; 7. it shall have a number of competent personnel at its disposal sufficient for the proper performance of its tasks; 8. it shall document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence; 9. it shall establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved; 10. it shall verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process; 11. it shall publish audited annual accounts prepared in accordance with generally accepted accounting principles. Article 9 Compliance with requirements 1. Where a national accreditation body does not meet the requirements of this Regulation or fails to fulfil its obligations hereunder, the Member State concerned shall take appropriate corrective action or shall ensure that such corrective action is taken, and shall inform the Commission thereof. 2. Member States shall monitor their national accreditation bodies at regular intervals in order to ensure that they fulfil the requirements laid down in Article 8 on a continuing basis. 3. Member States shall take the utmost account of the results of peer evaluation under Article 10 when carrying out the monitoring referred to in paragraph 2 of this Article. 4. National accreditation bodies shall have in place the necessary procedures to deal with complaints against the conformity assessment bodies they have accredited. Article 10 Peer evaluation 1. National accreditation bodies shall subject themselves to peer evaluation organised by the body recognised under Article 14. 2. Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities, but not in individual peer evaluation procedures. 3. Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation as required by paragraph 1. 4. Peer evaluation shall be operated on the basis of sound and transparent evaluation criteria and procedures, in particular concerning structural, human resource and process requirements, confidentiality and complaints. Appropriate appeal procedures against decisions taken as a result of such evaluation shall be provided for. 5. Peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 8, taking into account the relevant harmonised standards referred to in Article 11. 6. The outcome of peer evaluation shall be published and communicated by the body recognised under Article 14 to all Member States and the Commission. 7. The Commission shall, in cooperation with the Member States, oversee the rules and the proper functioning of the peer evaluation system. Article 11 Presumption of conformity for national accreditation bodies 1. National accreditation bodies that demonstrate conformity with the criteria laid down in the relevant harmonised standard, the reference of which has been published in the Official Journal of the European Union, by having successfully undergone peer evaluation under Article 10 shall be presumed to fulfil the requirements laid down in Article 8. 2. National authorities shall recognise the equivalence of the services delivered by those accreditation bodies which have successfully undergone peer evaluation under Article 10, and thereby accept, on the basis of the presumption referred to in paragraph 1 of this Article, the accreditation certificates of those bodies and the attestations issued by the conformity assessment bodies accredited by them. Article 12 Information obligation 1. Each national accreditation body shall inform the other national accreditation bodies of the conformity assessment activities in respect of which it operates accreditation and of any changes thereto. 2. Each Member State shall inform the Commission and the body recognised under Article 14 of the identity of its national accreditation body and of all conformity assessment activities in respect of which that body operates accreditation in support of Community harmonisation legislation, and of any changes thereto. 3. Each national accreditation body shall regularly make publicly available information concerning the results of its peer evaluation, the conformity assessment activities in respect of which it operates accreditation and any changes thereto. Article 13 Requests to the body recognised under Article 14 1. The Commission may, after consulting the Committee set up by Article 5 of Directive 98/34/EC, request the body recognised under Article 14 to contribute to the development, maintenance and implementation of accreditation in the Community. 2. The Commission may also, following the procedure laid down in paragraph 1: (a) request the body recognised under Article 14 to lay down evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes; (b) accept any existing scheme that already lays down evaluation criteria and procedures for peer evaluation. 3. The Commission shall ensure that sectoral schemes identify the technical specifications necessary to meet the level of competence required by Community harmonisation legislation in fields with specific requirements relating to technology, health and safety or environment related requirements or any other aspect of public interest protection. Article 14 European accreditation infrastructure 1. The Commission shall, after consulting the Member States, recognise a body which satisfies the requirements set out in Annex I to this Regulation. 2. A body which is to be recognised pursuant to paragraph 1 shall conclude an agreement with the Commission. That agreement shall specify, inter alia, the detailed tasks of the body, funding provisions and provisions for its supervision. Both the Commission and the body shall be able to terminate the agreement without cause at the expiry of a reasonable period of notice to be defined therein. 3. The Commission and the body shall make the agreement public. 4. The Commission shall communicate the recognition of a body pursuant to paragraph 1 to the Member States and to national accreditation bodies. 5. The Commission may not recognise more than one body at a time. 6. The first body recognised under this Regulation shall be the European cooperation for accreditation, provided that it has concluded an agreement as specified in paragraph 2. CHAPTER III COMMUNITY MARKET SURVEILLANCE FRAMEWORK AND CONTROLS OF PRODUCTS ENTERING THE COMMUNITY MARKET SECTION 1 General provisions Article 15 Scope 1. Articles 16 to 26 shall apply to products covered by Community harmonisation legislation. 2. Each of the provisions of Articles 16 to 26 shall apply in so far as there are no specific provisions with the same objective in Community harmonisation legislation. 3. The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC. 4. For the purposes of Articles 16 to 26, a \u2018product\u2019 shall mean a substance, preparation or good produced through a manufacturing process other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. 5. Articles 27, 28 and 29 shall apply to all products covered by Community legislation in so far as other Community legislation does not contain specific provisions relating to the organisation of border controls. Article 16 General requirements 1. Member States shall organise and carry out market surveillance as provided for in this Chapter. 2. Market surveillance shall ensure that products covered by Community harmonisation legislation which, when used in accordance with their intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation are withdrawn or their being made available on the market is prohibited or restricted and that the public, the Commission and the other Member States are informed accordingly. 3. National market surveillance infrastructures and programmes shall ensure that effective measures can be taken in relation to any product category subject to Community harmonisation legislation. 4. Market surveillance shall cover products assembled or manufactured for the manufacturer's own use where Community harmonisation legislation provides that its provisions shall apply to such products. SECTION 2 Community market surveillance framework Article 17 Information obligations 1. Member States shall inform the Commission of their market surveillance authorities and their areas of competence. The Commission shall transmit that information to the other Member States. 2. Member States shall ensure that the public is aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted. Article 18 Obligations of the Member States as regards organisation 1. Member States shall establish appropriate communication and coordination mechanisms between their market surveillance authorities. 2. Member States shall establish adequate procedures in order to: (a) follow up complaints or reports on issues relating to risks arising in connection with products subject to Community harmonisation legislation; (b) monitor accidents and harm to health which are suspected to have been caused by those products; (c) verify that corrective action has been taken; and (d) follow up scientific and technical knowledge concerning safety issues. 3. Member States shall entrust market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks. 4. Member States shall ensure that market surveillance authorities exercise their powers in accordance with the principle of proportionality. 5. Member States shall establish, implement and periodically update their market surveillance programmes. Member States shall draw up either a general market surveillance programme or sector specific programmes, covering the sectors in which they conduct market surveillance, communicate those programmes to the other Member States and the Commission and make them available to the public, by way of electronic communication and, where appropriate, by other means. The first such communication shall be effected by 1 January 2010. Subsequent updates of the programmes shall be made public in the same manner. Member States may cooperate with all relevant stakeholders to those ends. 6. Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every fourth year and the results thereof shall be communicated to the other Member States and the Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means. Article 19 Market surveillance measures 1. Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they shall take account of established principles of risk assessment, complaints and other information. Market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities, and, where it is necessary and justified, enter the premises of economic operators and take the necessary samples of products. They may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary. Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities shall take due account of such reports or certificates. 2. Market surveillance authorities shall take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage. They shall cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators. 3. Where the market surveillance authorities of one Member State decide to withdraw a product manufactured in another Member State, they shall inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying that product. 4. Market surveillance authorities shall carry out their duties independently, impartially and without bias. 5. Market surveillance authorities shall observe confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, subject to the requirement that information be made public under this Regulation to the fullest extent necessary in order to protect the interests of users in the Community. Article 20 Products presenting a serious risk 1. Member States shall ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22. 2. The decision whether or not a product represents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk. Article 21 Restrictive measures 1. Member States shall ensure that any measure taken, pursuant to the relevant Community harmonisation legislation, to prohibit or restrict the product's being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based. 2. Such measures shall be communicated without delay to the relevant economic operator, which shall at the same time be informed of the remedies available under the law of the Member State concerned and of the time limits to which such remedies are subject. 3. Prior to the adoption of a measure referred to in paragraph 1, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 days, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by health or safety requirements or other grounds relating to the public interests covered by the relevant Community harmonisation legislation. If action has been taken without the operator's being heard, the operator shall be given the opportunity to be heard as soon as possible and the action taken shall be reviewed promptly thereafter. 4. Any measure referred to in paragraph 1 shall be promptly withdrawn or amended upon the economic operator's demonstrating that he has taken effective action. Article 22 Exchange of information \u2014 Community Rapid Information System 1. Where a Member State takes or intends to take a measure in accordance with Article 20 and considers that the reasons which prompted the measure or the effects of the measure go beyond its territory, it shall immediately notify the Commission of that measure, in accordance with paragraph 4 of this Article. It shall also inform the Commission without delay of the modification or withdrawal of any such measure. 2. If a product presenting a serious risk has been made available on the market, Member States shall notify the Commission of any voluntary measures taken and communicated by an economic operator. 3. The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the related risk, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators. 4. For the purposes of paragraphs 1, 2 and 3, the market surveillance and information exchange system provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis. Article 23 General information support system 1. The Commission shall develop and maintain a general archiving and exchange of information system, using electronic means, on issues relating to market surveillance activities, programmes and related information on non-compliance with Community harmonisation legislation. The system shall appropriately reflect notifications and information provided under Article 22. 2. For the purposes of paragraph 1, Member States shall provide the Commission with information at their disposal and not already provided under Article 22 on products presenting a risk regarding, in particular, identification of risks, results of testing carried out, provisional restrictive measures taken, contacts with the economic operators concerned and justification for action or inaction. 3. Without prejudice to Article 19(5) or to national legislation in the area of confidentiality, the safeguarding of confidentiality with regard to the information content shall be ensured. The protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information relevant to ensuring the effectiveness of market surveillance activities. Article 24 Principles of cooperation between the Member States and the Commission 1. Member States shall ensure efficient cooperation and exchange of information between their market surveillance authorities and those of the other Member States and between their own authorities and the Commission and the relevant Community agencies regarding their market surveillance programmes and all issues relating to products presenting risks. 2. For the purposes of paragraph 1, the market surveillance authorities of one Member State shall give the market surveillance authorities of other Member States assistance on an adequate scale by supplying information or documentation, by carrying out appropriate investigations or any other appropriate measure and by participating in investigations initiated in other Member States. 3. The Commission shall collect and organise such data on national market surveillance measures as will enable it to fulfil its obligations. 4. Any information provided by an economic operator under Article 21(3) or otherwise shall be included when the reporting Member State notifies other Member States and the Commission of its findings and actions. Any subsequent information shall be clearly identified as relating to the information already provided. Article 25 Sharing of resources 1. Market surveillance initiatives designed to share resources and expertise between the competent authorities of the Member States may be set up by the Commission or the Member States concerned. Such initiatives shall be coordinated by the Commission. 2. For the purposes of paragraph 1, the Commission shall, in cooperation with the Member States: (a) develop and organise training programmes and exchanges of national officials; (b) develop, organise and set up programmes for the exchange of experience, information and best practice, programmes and actions for common projects, information campaigns, joint visit programmes and the consequent sharing of resources. 3. Member States shall ensure that their competent authorities participate fully in the activities referred to in paragraph 2, where appropriate. Article 26 Cooperation with the competent authorities of third countries 1. Market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support, promoting and facilitating access to European systems and promoting activities relating to conformity assessment, market surveillance and accreditation. The Commission shall, in cooperation with Member States, develop appropriate programmes for that purpose. 2. Cooperation with the competent authorities of third countries shall take the form of, inter alia, the activities referred to in Article 25(2). Member States shall ensure that their competent authorities participate fully in those activities. SECTION 3 Controls of products entering the Community market Article 27 Controls of products entering the Community market 1. The authorities of the Member States in charge of the control of products entering the Community market shall have the powers and resources necessary for the proper performance of their tasks. They shall carry out appropriate checks on the characteristics of products on an adequate scale, in accordance with the principles set out in Article 19(1), before those products are released for free circulation. 2. Where in a Member State more than one authority is responsible for market surveillance or external border controls, those authorities shall cooperate with each other, by sharing information relevant to their functions and otherwise as appropriate. 3. The authorities in charge of external border controls shall suspend release of a product for free circulation on the Community market when any of the following findings are made in the course of the checks referred to in paragraph 1: (a) the product displays characteristics which give cause to believe that the product, when properly installed, maintained and used, presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1; (b) the product is not accompanied by the written or electronic documentation required by the relevant Community harmonisation legislation or is not marked in accordance with that legislation; (c) the CE marking has been affixed to the product in a false or misleading manner. The authorities in charge of external border controls shall immediately notify the market surveillance authorities of any such suspension. 4. In the case of perishable products, the authorities in charge of external border controls shall, as far as possible, seek to ensure that any requirements they may impose with regard to the storage of products or the parking of vehicles used for transport are not incompatible with the preservation of those products. 5. For the purposes of this Section, Article 24 shall apply in respect of authorities in charge of external border controls, without prejudice to the application of Community law providing for more specific systems of cooperation between those authorities. Article 28 Release of products 1. A product the release of which has been suspended by the authorities in charge of external border controls pursuant to Article 27 shall be released if, within three working days of the suspension of release, those authorities have not been notified of any action taken by the market surveillance authorities, and provided that all the other requirements and formalities pertaining to such release have been fulfilled. 2. Where the market surveillance authorities find that the product in question does not present a serious risk to health and safety or cannot be regarded as being in breach of Community harmonisation legislation, that product shall be released, provided that all the other requirements and formalities pertaining to such release have been fulfilled. Article 29 National measures 1. Where the market surveillance authorities find that a product presents a serious risk, they shall take measures to prohibit that product from being placed on the market and shall require the authorities in charge of external border controls to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself: \u2018Dangerous product \u2014 release for free circulation not authorised \u2014 Regulation (EC) No 765/2008\u2019. 2. Where the market surveillance authorities find that a product does not comply with Community harmonisation legislation, they shall take appropriate action, which may, if necessary, include prohibiting the product's being placed on the market. Where placing on the market is prohibited pursuant to the first subparagraph, the market surveillance authorities shall require the authorities in charge of external border controls not to release the product for free circulation and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself: \u2018Product not in conformity \u2014 release for free circulation not authorised \u2014 Regulation (EC) No 765/2008\u2019. 3. Where that product is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the endorsements set out in paragraphs 1 and 2 shall also be included, under the same conditions, on the documents used in connection with that procedure. 4. Member States' authorities may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary and proportionate. 5. Market surveillance authorities shall provide authorities in charge of external border controls with information on product categories in which a serious risk or non-compliance within the meaning of paragraphs 1 and 2 has been identified. CHAPTER IV CE MARKING Article 30 General principles of the CE marking 1. The CE marking shall be affixed only by the manufacturer or his authorised representative. 2. The CE marking as presented in Annex II shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product. 3. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing. 4. The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing. 5. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired. 6. Without prejudice to Article 41, Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use. CHAPTER V COMMUNITY FINANCING Article 31 Body pursuing an aim of general European interest The body recognised under Article 14 shall be considered a body pursuing an aim of general European interest within the meaning of Article 162 of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Regulation (EC, Euratom) No 1605/2002 (12). Article 32 Activities eligible for Community financing 1. The Community may finance the following activities in connection with the application of this Regulation: (a) the production and revision of sectoral accreditation schemes referred to in Article 13(3); (b) the activities of the secretariat of the body recognised under Article 14, such as the coordination of accreditation activities, the processing of technical work linked to the operation of the peer evaluation system, the provision of interested parties with information and the participation of the body in the activities of international organisations in the field of accreditation; (c) the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies, conformity assessment and market surveillance; (d) inter-comparison activities linked to the operation of safeguard clauses; (e) the making available to the Commission of technical expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation, including the financing of administrative cooperation groups, market surveillance decisions and safeguard clause cases; (f) the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology, accreditation and market surveillance activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work, as well as European market surveillance campaigns and similar activities; (g) activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment, market surveillance and accreditation policies and systems among interested parties in the Community and at international level. 2. The activities referred to in paragraph 1(a) shall be eligible for Community financing only if the Committee set up by Article 5 of Directive 98/34/EC has been consulted on the requests to be submitted to the body recognised under Article 14 of this Regulation. Article 33 Bodies eligible for Community financing Community financing may be granted to the body recognised under Article 14 for the implementation of the activities set out in Article 32. However, Community financing may also be granted to other bodies for the carrying out of the activities set out in Article 32, except those set out in paragraph 1(a) and (b) of that Article. Article 34 Financing The appropriations allocated to the activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force. Article 35 Financing arrangements 1. Community financing shall be provided: (a) without a call for proposals, to the body recognised under Article 14 to carry out those activities referred to in Article 32(1)(a) to (g) for which grants can be awarded in accordance with the Financial Regulation; (b) in the form of grants after a call for proposals, or by public procurement procedures, to other bodies to carry out the activities referred to in Article 32(1)(c) to (g). 2. The activities of the secretariat of the body recognised under Article 14 referred to in Article 32(1)(b) may be financed on the basis of operating grants. In the event of renewal, the operating grants shall not be decreased automatically. 3. Grant agreements may authorise flat-rate cover of the beneficiary's overheads up to a maximum of 10 % of total eligible direct costs for actions, except where the beneficiary's indirect costs are covered through an operating grant financed from the Community budget. 4. The common cooperation objectives and the administrative and financial conditions relating to the grants awarded to the body recognised under Article 14 may be defined in a framework partnership agreement signed by the Commission and that body, in accordance with the Financial Regulation and Regulation (EC, Euratom) No 2342/2002. The European Parliament and the Council shall be informed of the conclusion of any such agreement. Article 36 Management and monitoring 1. The appropriations determined by the budgetary authority for the financing of conformity assessment, accreditation and market surveillance activities may also cover administrative expenses relating to preparation, monitoring, inspection, auditing and evaluation which are directly necessary for the achievement of the objectives of this Regulation, and in particular studies, meetings, information and publication activities, expenses relating to informatics networks for the exchange of information and any other expenditure on administrative and technical assistance which the Commission may use for conformity assessment and accreditation activities. 2. The Commission shall evaluate the relevance of the conformity assessment, accreditation and market surveillance activities that receive Community financing in the light of the requirements of Community policies and legislation, and inform the European Parliament and the Council of the outcome of that evaluation by 1 January 2013 and every five years thereafter. Article 37 Protection of the Community's financial interests 1. The Commission shall ensure that, when the activities financed under this Regulation are implemented, the Community's financial interests are protected by the application of preventive measures against fraud, corruption and other illegal activities, by effective checks and by the recovery of amounts unduly paid and, if irregularities are detected, by effective, proportionate and dissuasive penalties, in accordance with Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (13), Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (14) and Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (15). 2. For the purposes of the Community activities financed under this Regulation, the notion of irregularity referred to in Article 1(2) of Regulation (EC, Euratom) No 2988/95 shall mean any infringement of a provision of Community law or any breach of a contractual obligation resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the European Union or budgets managed by it by an unjustified item of expenditure. 3. Any agreements and contracts resulting from this Regulation shall provide for monitoring and financial control by the Commission or any representative which it authorises and for audits by the Court of Auditors, which may be conducted on the spot if necessary. CHAPTER VI FINAL PROVISIONS Article 38 Technical guidelines In order to facilitate the implementation of this Regulation, the Commission shall draw up non-binding guidelines in consultation with stakeholders. Article 39 Transitional provision Accreditation certificates issued before 1 January 2010 may remain valid until the date of their expiry, but no later than 31 December 2014. This Regulation shall, however, apply in the case of their extension or renewal. Article 40 Review and reporting By 2 September 2013, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, of Directive 2001/95/EC and of any other relevant Community instrument addressing market surveillance. That report shall, in particular, analyse the consistency of Community rules in the field of market surveillance. If appropriate, it shall be accompanied by proposals to amend and/or consolidate the instruments concerned, in the interests of better regulation and simplification. It shall include an evaluation of the extension of the scope of Chapter III of this Regulation to all products. By 1 January 2013, and every five years thereafter, the Commission, in cooperation with the Member States, shall produce and submit to the European Parliament and to the Council a report on the implementation of this Regulation. Article 41 Penalties The Member States shall lay down rules on penalties for economic operators, which may include criminal sanctions for serious infringements, applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement of the provisions of this Regulation. The Member States shall notify the Commission of those provisions by 1 January 2010 and shall notify it without delay of any subsequent amendment affecting them. Article 42 Amendment to Directive 2001/95/EC Article 8(3) of Directive 2001/95/EC shall be replaced by the following: \u20183. In the case of products posing a serious risk, the competent authorities shall with due dispatch take the appropriate measures referred to in paragraph 1(b) to (f). The existence of a serious risk shall be determined by the Member States, assessing each individual case on its merits and taking into account the guidelines referred to in point 8 of Annex II.\u2019. Article 43 Repeal Regulation (EEC) No 339/93 is hereby repealed with effect from 1 January 2010. References to the repealed Regulation shall be construed as references to this Regulation. Article 44 Entry into force This Regulation shall enter into force on the 20th day after its publication in the Official Journal of the European Union. It shall apply from 1 January 2010. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 July 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J.-P. JOUYET (1) OJ C 120, 16.5.2008, p. 1. (2) Opinion of the European Parliament of 21 February 2008 (not yet published in the Official Journal) and Council Decision of 23 June 2008. (3) See page 82 of this Official Journal. (4) OJ L 11, 15.1.2002, p. 4. (5) OJ L 145, 31.5.2001, p. 43. (6) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). (7) OJ L 8, 12.1.2001, p. 1. (8) OJ L 40, 17.2.1993, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). (9) OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regulation (EC) No 1525/2007 (OJ L 343, 27.12.2007, p. 9). (10) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81). (11) OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). (12) OJ L 357, 31.12.2002, p. 1. Regulation as last amended by Regulation (EC, Euratom) No 478/2007 (OJ L 111, 28.4.2007, p. 13). (13) OJ L 312, 23.12.1995, p. 1. (14) OJ L 292, 15.11.1996, p. 2. (15) OJ L 136, 31.5.1999, p. 1. ANNEX I Requirements applicable to the body to be recognised under Article 14 1. The body recognised under Article 14 of the Regulation (the body), shall be established within the Community. 2. Under the body's constitution, national accreditation bodies from within the Community shall be entitled to be members of it, provided that they comply with the rules and objectives of the body and with the other conditions set out herein and as agreed with the Commission in the framework agreement. 3. The body shall consult all relevant stakeholders. 4. The body shall provide its members with peer evaluation services satisfying the requirements of Articles 10 and 11. 5. The body shall cooperate with the Commission in accordance with this Regulation. ANNEX II CE marking 1. The CE marking shall consist of the initials \u2018CE\u2019 taking the following form: 2. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing in paragraph 1 shall be respected. 3. Where specific legislation does not impose specific dimensions, the CE marking shall be at least 5 mm high.", "summary": "Accreditation and market surveillance Accreditation and market surveillance SUMMARY OF: Regulation (EC) No 765/2008 \u2014 setting out the requirements for accreditation and market surveillance relating to the marketing of products WHAT IS THE AIM OF THE REGULATION? It lays down common rules for accrediting bodies that ensure non-food products in the European Union (EU) conform to certain requirements. It establishes a surveillance system to guarantee a high level of safety of those products and in general their compliance with applicable requirements. It also sets rules in regard to controls on imports from outside the EU; and establishes the general principles for CE marking*. KEY POINTS National accreditation bodies EU countries must: appoint a single not-for-profit national accreditation organisation; ensure the organisation has sufficient finance and staff to carry out its duties; monitor the organisation to ensure it fulfils the requirements given; communicate the relevant details to the European Commission which draws up a publicly available list of the various national organisations. National accreditation bodies must: determine whether individual conformity assessment organisations* are competent to do their work and monitor their performance; restrict, suspend or withdraw accreditation certificates for assessment organisations that become unable to carry out their duties; be objective and impartial with efficient management and appropriate internal controls in place; agree to peer evaluation; inform other national accreditation bodies of their conformity assessment activities; make regularly publicly available information on their work. The European co-operation for Accreditation (EA) manages the peer evaluations to ensure the quality of the services the national accreditation bodies provide. EU market surveillance and import controls EU countries must: organise and carry out market surveillance to ensure the safety of products; withdraw, restrict or ban products that could damage the health or safety of users and immediately inform the Commission of the action they have taken; establish procedures for handling and dealing with complaints; ensure national market surveillance authorities are appointed and provided with sufficient resources to carry out their tasks; ensure national market surveillance authorities cooperate and exchange information with each other; establish rules on penalties, which may include criminal sanctions, for serious breaches of the law. Market surveillance authorities must: carry out appropriate checks on a sufficient scale, taking account of risk assessments, complaints and other information; alert users in their own country of any dangers they discover; inform the EU\u2019s rapid information system (RAPEX) of any serious risks; exchange information on product compliance via a common EU database; cooperate with authorities in other EU countries. National customs authorities may prevent an imported product from being sold in the EU if they believe it poses a serious risk to health, safety, the environment or any other public interest. CE marking may only be attached to a product by a manufacturer or someone mandated to operate on their behalf, provided it satisfies all the conformity standards. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2010. BACKGROUND It is essential that non-food products that can move freely between EU countries do not pose a danger to the public, the environment or general security. Accreditation is part of an overall system that includes conformity assessment and market surveillance. Provisions in the regulation for the latter complement those set out in other pieces of EU legislation. For more information, see: \u2018Market surveillance for products\u2019 on the European Commission's website. * KEY TERMS CE marking: a marking manufacturers use to indicate the item meets EU legal conformity standards. Conformity assessment body: a body that performs activities which include calibration, testing, certification and inspection. MAIN DOCUMENT Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30-47) RELATED DOCUMENTS Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4-17) Successive amendments to Directive 2001/95/EC have been incorporated into the original document. This consolidated version is of documentary value only. Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82-128) Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008, pp. 21-29) last update 14.02.2017"}
{"article": "EUR-Lex - 22006A1021(01) - EN Important legal notice | 22006A1021(01) Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway - Declarations Official Journal L 292 , 21/10/2006 P. 0002 - 0019 Agreementbetween the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and NorwayTHE EUROPEAN UNION,on the one hand, andTHE REPUBLIC OF ICELANDandTHE KINGDOM OF NORWAY,on the other hand,hereinafter referred to as \"the Contracting Parties\",WISHING to improve judicial cooperation in criminal matters between the Member States of the European Union and Iceland and Norway, without prejudice to the rules protecting individual freedom,CONSIDERING that current relationships among the Contracting Parties require close cooperation in the fight against crime,EXPRESSING their mutual confidence in the structure and functioning of their legal systems and in the ability of all Contracting Parties to guarantee a fair trial,CONSIDERING that Iceland and Norway have expressed their wish to enter into an agreement enabling them to expedite arrangements for handing over suspects and convicts with the Member States of the European Union and to apply a surrender procedure with the Member States,CONSIDERING that the European Union also considers it desirable to have such an agreement in place,CONSIDERING that it is therefore appropriate to set up a system for such surrender procedure,CONSIDERING that all Member States and the Kingdom of Norway and the Republic of Iceland are parties to a number of conventions in the field of extradition, including the European Convention on extradition of 13 December 1957 and the European Convention on the suppression of terrorism of 27 January 1977. The Nordic States have uniform extradition laws with a common concept of extradition,CONSIDERING that the level of cooperation under the EU Convention of 10 March 1995 on simplified extradition procedure and of the EU Convention of 27 September 1996 relating to extradition should be maintained where it is not possible to increase it,CONSIDERING that decisions on the execution of the arrest warrant as defined by this Agreement must be subject to sufficient controls, which means that a judicial authority of the State where the requested person has been arrested should have to take the decision on his or her surrender,CONSIDERING that the role of central authorities in the execution of an arrest warrant as defined by this Agreement should be limited to practical and administrative assistance,CONSIDERING that this Agreement respects fundamental rights and in particular the European Convention on Human Rights and Fundamental Freedoms.This Agreement does not prevent a State from applying its constitutional rules relating to due process, freedom of association, freedom of the press, freedom of expression in other media and freedom fighters,CONSIDERING that no person should be surrendered to a State where there is a serious risk that he or she would be subjected to the death penalty, torture or other inhuman or degrading treatment or punishment,CONSIDERING that since all States have ratified the Council of Europe Convention of 28 January 1981 for the protection of individuals with regard to automatic processing of personal data, the personal data processed in the context of the implementation of this Agreement should be protected in accordance with the principles of the said Convention,HAVE AGREED AS FOLLOWS:CHAPTER 1GENERAL PRINCIPLESArticle 1Object and purpose1. The Contracting Parties undertake to improve, in accordance with the provisions of this Agreement, the surrender for the purpose of prosecution or execution of sentence between, on the one hand, the Member States and, on the other hand, the Kingdom of Norway and the Republic of Iceland, by taking account of, as minimum standards, the terms of the Convention of 27 September 1996 relating to extradition between the Member States of the European Union.2. The Contracting Parties undertake, in accordance with the provisions of this Agreement, to ensure that the extradition system between, on the one hand, the Member States and, on the other hand, the Kingdom of Norway and the Republic of Iceland shall be based on a mechanism of surrender pursuant to an arrest warrant in accordance with the terms of this Agreement.3. This Agreement shall not have the effect of modifying the obligation to respect fundamental rights and fundamental legal principles as enshrined in the European Convention on Human Rights, or, in case of execution by the judicial authority of a Member State, of the principles referred to in Article 6 of the Treaty on European Union.4. Nothing in this Agreement should be interpreted as prohibiting refusal to surrender a person in respect of whom an arrest warrant as defined by this Agreement has been issued when there are reasons to believe, on the basis of objective elements, that the said arrest warrant has been issued for the purpose of prosecuting or punishing a person on the grounds of his or her sex, race, religion, ethnic origin, nationality, language, political opinions or sexual orientation, or that that person's position may be prejudiced for any of these reasons.Article 2Definitions1. \"Contracting Parties\" shall mean the European Union and the Kingdom of Norway and the Republic of Iceland.2. \"Member State\" shall mean a Member State of the European Union.3. \"State\" shall mean a Member State, the Kingdom of Norway or the Republic of Iceland.4. \"Third State\" shall mean any State other than a State as defined in paragraph 3.5. \"Arrest warrant\" shall mean a judicial decision issued by a State with a view to the arrest and surrender by another State of a requested person, for the purposes of conducting a criminal prosecution or executing a custodial sentence or detention order.Article 3Scope1. An arrest warrant may be issued for acts punishable by the law of the issuing State by a custodial sentence or a detention order for a maximum period of at least 12 months or, where a sentence has been passed or a detention order has been made, for sentences of at least four months.2. Without prejudice to paragraphs 3 and 4, surrender shall be subject to the condition that the acts for which the arrest warrant has been issued constitute an offence under the law of the executing State, whatever the constituent elements or however it is described.3. Subject to Articles 4, 5(1)(b) to (g), 6, 7 and 8, in no case shall a State refuse to execute an arrest warrant issued in relation to the behaviour of any person who contributes to the commission by a group of persons acting with a common purpose of one or more offences in the field of terrorism referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism and Articles 1, 2, 3 and 4 of the Framework Decision of 13 June 2002 on combating terrorism, illicit trafficking in narcotic drugs and psychotropic substances, or murder, grievous bodily injury, kidnapping, illegal restraint, hostage-taking and rape, punishable by deprivation of liberty or a detention order of a maximum of at least 12 months, even where that person does not take part in the actual execution of the offence or offences concerned; such contribution shall be intentional and made with the further knowledge that his or her participation will contribute to the achievement of the organisation's criminal activities.4. Norway and Iceland, on the one hand, and the EU, on behalf of any of its Member States, on the other hand may make a declaration to the effect that, on the basis of reciprocity, the condition of double criminality referred to in paragraph 2 shall not be applied under the conditions set out hereafter. The following offences, if they are punishable in the issuing State by a custodial sentence or a detention order for a maximum period of at least three years and as they are defined by the law of the issuing State, shall, under the terms of this Agreement and without verification of the double criminality of the act, give rise to surrender pursuant to an arrest warrant:- participation in a criminal organisation,- terrorism,- trafficking in human beings,- sexual exploitation of children and child pornography,- illicit trafficking in narcotic drugs and psychotropic substances,- illicit trafficking in weapons, munitions and explosives,- corruption,- fraud, including that affecting the financial interests of the European Communities within the meaning of the Convention of 26 July 1995 on the protection of the European Communities' financial interests,- laundering of the proceeds of crime,- counterfeiting currency, including of the euro,- computer-related crime,- environmental crime, including illicit trafficking in endangered animal species and in endangered plant species and varieties,- facilitation of unauthorised entry and residence,- murder, grievous bodily injury,- illicit trade in human organs and tissue,- kidnapping, illegal restraint and hostage-taking,- racism and xenophobia,- organised or armed robbery,- illicit trafficking in cultural goods, including antiques and works of art,- swindling,- racketeering and extortion,- counterfeiting and piracy of products,- forgery of administrative documents and trafficking therein,- forgery of means of payment,- illicit trafficking in hormonal substances and other growth promoters,- illicit trafficking in nuclear or radioactive materials,- trafficking in stolen vehicles,- rape,- arson,- crimes within the jurisdiction of the International Criminal Court,- unlawful seizure of aircraft/ships,- sabotage.Article 4Grounds for mandatory non-execution of the arrest warrantStates shall establish an obligation for the executing judicial authority to refuse to execute the arrest warrant in the following cases:1) if the offence on which the arrest warrant is based is covered by amnesty in the executing State, where that State had jurisdiction to prosecute the offence under its own criminal law;2) if the executing judicial authority is informed that the requested person has been finally judged by a State in respect of the same acts provided that, where there has been sentence, the sentence has been served or is currently being served or may no longer be executed under the law of the sentencing State;3) if the person who is the subject of the arrest warrant may not, owing to his age, be held criminally responsible for the acts on which the arrest warrant is based under the law of the executing State.Article 5Other grounds for non-execution of the arrest warrant1. States can establish an obligation or an option for the executing judicial authority to refuse to execute the arrest warrant in the following cases:(a) if, in one of the cases referred to in Article 3(2), the act on which the arrest warrant is based does not constitute an offence under the law of the executing State; however, in relation to taxes or duties, customs and exchange, execution of the arrest warrant shall not be refused on the ground that the law of the executing State does not impose the same kind of tax or duty or does not contain the same type of rules as regards taxes, duties and customs and exchange regulations as the law of the issuing State;(b) where the person who is the subject of the arrest warrant is being prosecuted in the executing State for the same act as that on which the arrest warrant is based;(c) where the judicial authorities of the executing State have decided either not to prosecute for the offence on which the arrest warrant is based or to halt proceedings, or where a final judgement has been passed upon the requested person in a State, in respect of the same acts, which prevents further proceedings;(d) where the criminal prosecution or punishment of the requested person is statute-barred according to the law of the executing State and the acts fall within the jurisdiction of that State under its own criminal law;(e) if the executing judicial authority is informed that the requested person has been finally judged by a third State in respect of the same acts provided that, where there has been sentence, the sentence has been served or is currently being served or may no longer be executed under the law of the sentencing country;(f) if the arrest warrant has been issued for the purposes of execution of a custodial sentence or detention order, where the requested person is staying in, or is a national or a resident of the executing State and that State undertakes to execute the sentence or detention order in accordance with its domestic law;(g) where the arrest warrant relates to offences which:(i) are regarded by the law of the executing State as having been committed in whole or in part in the territory of the executing State or in a place treated as such;or(ii) have been committed outside the territory of the issuing State and the law of the executing State does not allow prosecution for the same offences when committed outside its territory.2. Each State shall inform the General Secretariat of the Council for which of the grounds of non-execution of paragraph 1, it has established an obligation for its executing judicial authorities to refuse the execution of an arrest warrant. The General Secretariat shall make the information received available to all States and the Commission.Article 6Political offence exception1. Execution may not be refused on the ground that the offence may be regarded by the executing State as a political offence, as an offence connected with a political offence or an offence inspired by political motives.2. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may make, however, a declaration to the effect that paragraph 1 will be applied only in relation to:(a) the offences referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism;(b) offences of conspiracy or association \u2014 which correspond to the description of behaviour referred to in Article 3(3) \u2014 to commit one or more of the offences referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism;and(c) Articles 1, 2, 3 and 4 of the Framework Decision of 13 June 2002 on combating terrorism.3. Where an arrest warrant has been issued by a State having made a declaration as referred to in paragraph 2, or by a State on behalf of which such a declaration has been made, the State executing the arrest warrant, may apply reciprocity.Article 7Nationality exception1. Execution may not be refused on the ground that the person claimed is a national of the executing State.2. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may make a declaration to the effect that nationals will not be surrendered or that surrender will be authorised only under certain specified conditions.3. Where an arrest warrant has been issued by a State having made a declaration as referred to in paragraph 2, or by a State for which such a declaration has been made, any other State may, in the execution of the arrest warrant, apply reciprocity.Article 8Guarantees to be given by the issuing State in particular casesThe execution of the arrest warrant by the executing judicial authority may be subject to the following conditions:1) where the arrest warrant has been issued for the purposes of executing a sentence or a detention order imposed by a decision rendered in absentia and if the person concerned has not been summoned in person or otherwise informed of the date and place of the hearing which led to the decision rendered in absentia, surrender may be subject to the condition that the issuing judicial authority gives an assurance deemed adequate to guarantee the person who is the subject of the arrest warrant that he or she will have an opportunity to apply for a retrial of the case in the issuing State and to be present at the judgment;2) if the offence on the basis of which the arrest warrant has been issued is punishable by custodial life sentence or life-time detention order the execution of the said arrest warrant may be subject to the condition that the issuing State gives an assurance deemed sufficient by the executing state that it will review the penalty or measure imposed, on request or at the latest after 20 years, or will encourage the application of measures of clemency to which the person is entitled to apply for under the law or practice of the issuing State, aiming at a non-execution of such penalty or measure;3) where a person who is the subject of an arrest warrant for the purposes of prosecution is a national or resident of the executing State, surrender may be subject to the condition that the person, after being heard, is returned to the executing State in order to serve there the custodial sentence or detention order passed against him in the issuing State.Article 9Determination of the competent judicial authorities1. The issuing judicial authority shall be the judicial authority of the issuing State which is competent to issue an arrest warrant by virtue of the law of that State.2. The executing judicial authority shall be the judicial authority of the executing State which is competent to execute the arrest warrant by virtue of the law of that State. At the moment of notification referred to in Article 38(1), a Minister of Justice may be designated as a competent authority for the execution of an arrest warrant, whether or not the Minister of Justice is a judicial authority under the domestic law of that State.3. The Contracting Parties shall inform each other of their competent authorities.Article 10Recourse to the central authority1. The Contracting Parties may notify each other of the central authority for each State, having designated such an authority, or, when the legal system of the relevant State so provides, of more than one central authority to assist the competent judicial authorities.2. In doing so the Contracting Parties may indicate that, as a result of the organisation of the internal judicial system of the relevant States, the central authority(ies) are responsible for the administrative transmission and reception of arrest warrants as well as for all other official correspondence relating thereto. These indications shall be binding upon all the authorities of the issuing State.Article 11Content and form of the arrest warrant1. The arrest warrant shall contain the following information set out in accordance with the form contained in the Annex to this Agreement:(a) the identity and nationality of the requested person;(b) the name, address, telephone and fax numbers and e-mail address of the issuing judicial authority;(c) evidence of an enforceable judgement, an arrest warrant or any other enforceable judicial decision having the same effect, coming within the scope of Articles 2 and 3;(d) the nature and legal classification of the offence, particularly in respect of Article 3;(e) a description of the circumstances in which the offence was committed, including the time, place and degree of participation in the offence by the requested person;(f) the penalty imposed, if there is a final judgment, or the prescribed scale of penalties for the offence under the law of the issuing State;(g) if possible, other consequences of the offence.2. The arrest warrant must be translated into the official language or one of the official languages of the executing State. Any Contracting Party may, when this Agreement is concluded or at a later date, make a declaration to the effect that a translation in one or more other official languages of a State will be accepted.CHAPTER 2SURRENDER PROCEDUREArticle 12Transmission of an arrest warrant1. When the location of the requested person is known, the issuing judicial authority may transmit the arrest warrant directly to the executing judicial authority.2. The issuing judicial authority may, in any event, decide to issue an alert for the requested person in the Schengen Information System (SIS).Such an alert shall be effected in accordance with the relevant provisions of European Union law on alerts in the Schengen Information System on persons for the purpose of surrender. An alert in the Schengen Information System shall be equivalent to an arrest warrant accompanied by the information set out in Article 11(1).3. For a transitional period, until the SIS is capable of transmitting all the information described in Article 11, the alert shall be equivalent to an arrest warrant pending the receipt of the original in due and proper form by the executing judicial authority.Article 13Detailed procedures for transmitting an arrest warrant1. If the issuing judicial authority does not know the competent executing judicial authority, it shall make the requisite enquiries, in order to obtain that information from the executing State.2. If it is not possible to call on the services of the SIS, the issuing judicial authority may call on the International Criminal Police Organisation (Interpol) to transmit an arrest warrant.3. The issuing judicial authority may forward the arrest warrant by any secure means capable of producing written records under conditions allowing the executing State to establish its authenticity.4. All difficulties concerning the transmission or the authenticity of any document needed for the execution of the arrest warrant shall be dealt with by direct contacts between the judicial authorities involved, or, where appropriate, with the involvement of the central authorities of the States.5. If the authority which receives an arrest warrant is not competent to act upon it, it shall automatically forward the arrest warrant to the competent authority in its State and shall inform the issuing judicial authority accordingly.Article 14Rights of a requested person1. When a requested person is arrested, the executing competent judicial authority shall, in accordance with its national law, inform that person of the arrest warrant and of its contents, and also of the possibility of consenting to surrender to the issuing judicial authority.2. A requested person who is arrested for the purpose of the execution of an arrest warrant shall have a right to be assisted by a legal counsel and by an interpreter in accordance with the national law of the executing State.Article 15Keeping the person in detentionWhen a person is arrested on the basis of an arrest warrant, the executing judicial authority shall take a decision on whether the requested person should remain in detention, in accordance with the law of the executing State. The person may be released provisionally at any time in conformity with the domestic law of the executing State, provided that the competent authority of the said State takes all the measures it deems necessary to prevent the person absconding.Article 16Consent to surrender1. If the arrested person indicates that he or she consents to surrender, that consent and, if appropriate, express renunciation of entitlement to the \"speciality rule\", referred to in Article 30(2), shall be given before the executing judicial authority, in accordance with the domestic law of the executing State.2. Each State shall adopt the measures necessary to ensure that consent and, where appropriate, renunciation, as referred to in paragraph 1, are established in such a way as to show that the person concerned has expressed them voluntarily and in full awareness of the consequences. To that end, the requested person shall have the right to legal counsel.3. The consent and, where appropriate, renunciation, as referred to in paragraph 1, shall be formally recorded in accordance with the procedure laid down by the domestic law of the executing State.4. In principle, consent may not be revoked. Each State may provide that consent and, if appropriate, renunciation may be revoked, in accordance with the rules applicable under its domestic law. In this case, the period between the date of consent and that of its revocation shall not be taken into consideration in establishing the time limits laid down in Article 20. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may make, at the time of notification provided for in Article 38(1), a declaration indicating that they wish to have recourse to this possibility, specifying the procedures whereby revocation of consent shall be possible and any amendment to them.Article 17Hearing of the requested personWhere the arrested person does not consent to his or her surrender as referred to in Article 16, he or she shall be entitled to be heard by the executing judicial authority, in accordance with the law of the executing State.Article 18Surrender decision1. The executing judicial authority shall decide, within the time limits and under the conditions defined in this Agreement, whether the person is to be surrendered.2. If the executing judicial authority finds the information communicated by the issuing State to be insufficient to allow it to decide on surrender, it shall request that the necessary supplementary information, in particular with respect to Articles 4 to 6, 8 and 11, be furnished as a matter of urgency and may fix a time limit for the receipt thereof, taking into account the need to observe the time limits set in Article 20.3. The issuing judicial authority may at any time forward any additional useful information to the executing judicial authority.Article 19Decision in the event of multiple requests1. If two or more States have issued a European arrest warrant or an arrest warrant for the same person, the decision as to which of the arrest warrants shall be executed shall be taken by the executing judicial authority with due consideration of all the circumstances and especially the relative seriousness and place of the offences, the respective dates of the arrest warrants and whether the warrant has been issued for the purposes of prosecution or for execution of a custodial sentence or detention order.2. The executing judicial authority of a Member State may seek the advice of Eurojust when making the choice referred to in paragraph 1.3. In the event of a conflict between an arrest warrant and a request for extradition presented by a third State, the decision as to whether the arrest warrant or the extradition request takes precedence shall be taken by the competent authority of the executing State with due consideration of all the circumstances, in particular those referred to in paragraph 1 and those mentioned in the applicable convention.4. This Article shall be without prejudice to States' obligations under the Statute of the International Criminal Court.Article 20Time limits and procedures for the decision to execute the arrest warrant1. An arrest warrant shall be dealt with and executed as a matter of urgency.2. In cases where the requested person consents to his surrender, the final decision on the execution of the arrest warrant should be taken within a period of 10 days after consent has been given.3. In other cases, the final decision on the execution of the arrest warrant should be taken within a period of 60 days after the arrest of the requested person.4. Where in specific cases the arrest warrant cannot be executed within the time limits laid down in paragraphs 2 or 3, the executing judicial authority shall immediately inform the issuing judicial authority thereof, giving the reasons for the delay. In such case, the time limits may be extended by a further 30 days.5. The European Union, on behalf of any of its Member States, may make, at the time of notification provided for in Article 38(1), a declaration indicating in which cases paragraphs 3 and 4 will not apply. Norway and Iceland may apply reciprocity in relation to the Member States concerned.6. As long as the executing judicial authority has not taken a final decision on the arrest warrant, it shall ensure that the material conditions necessary for effective surrender of the person remain fulfilled.7. Reasons must be given for any refusal to execute an arrest warrant.Article 21Situation pending the decision1. Where the arrest warrant has been issued for the purpose of conducting a criminal prosecution, the executing judicial authority must:(a) either agree that the requested person should be heard according to Article 22;(b) or agree to the temporary transfer of the requested person.2. The conditions and the duration of the temporary transfer shall be determined by mutual agreement between the issuing and executing judicial authorities.3. In the case of temporary transfer, the person must be able to return to the executing State to attend hearings concerning him or her as part of the surrender procedure.Article 22Hearing the person pending the decision1. The requested person shall be heard by a judicial authority, assisted by another person designated in accordance with the law of the State of the requesting court.2. The requested person shall be heard in accordance with the law of the executing State and with the conditions determined by mutual agreement between the issuing and executing judicial authorities.3. The competent executing judicial authority may assign another judicial authority of its State to take part in the hearing of the requested person in order to ensure the proper application of this Article and of the conditions laid down.Article 23Privileges and immunities1. Where the requested person enjoys a privilege or immunity regarding jurisdiction or execution in the executing State, the time limits referred to in Article 20 shall not start running unless, and counting from the day when, the executing judicial authority is informed of the fact that the privilege or immunity has been waived.2. The executing State shall ensure that the material conditions necessary for effective surrender are fulfilled when the person no longer enjoys such privilege or immunity.3. Where power to waive the privilege or immunity lies with an authority of the executing State, the executing judicial authority shall request it to exercise that power forthwith. Where power to waive the privilege or immunity lies with an authority of another State or international organisation, it shall be for the issuing judicial authority to request it to exercise that power.Article 24Competing international obligationsThis Agreement shall not prejudice the obligations of the executing State where the requested person has been extradited to that State from a third State and where that person is protected by provisions of the arrangement under which he or she was extradited concerning speciality. The executing State shall take all necessary measures for requesting forthwith the consent of the State from which the requested person was extradited so that he or she can be surrendered to the State which issued the arrest warrant. The time limits referred to in Article 20 shall not start running until the day on which these speciality rules cease to apply.Pending the decision of the State from which the requested person was extradited, the executing State will ensure that the material conditions necessary for effective surrender remain fulfilled.Article 25Notification of the decisionThe executing judicial authority shall notify the issuing judicial authority immediately of the decision on the action to be taken on the arrest warrant.Article 26Time limits for surrender of the person1. The person requested shall be surrendered as soon as possible on a date agreed between the authorities concerned.2. He or she shall be surrendered no later than 10 days after the final decision on the execution of the arrest warrant.3. If the surrender of the requested person within the period laid down in paragraph 2 is prevented by circumstances beyond the control of any of the States, the executing and issuing judicial authorities shall immediately contact each other and agree on a new surrender date. In that event, the surrender shall take place within 10 days of the new date thus agreed.4. The surrender may exceptionally be temporarily postponed for serious humanitarian reasons, for example if there are substantial grounds for believing that it would manifestly endanger the requested person's life or health. The execution of the arrest warrant shall take place as soon as these grounds have ceased to exist. The executing judicial authority shall immediately inform the issuing judicial authority and agree on a new surrender date. In that event, the surrender shall take place within 10 days of the new date thus agreed.5. Upon expiry of the time limits referred to in paragraphs 2 to 4, if the person is still being held in custody he shall be released.Article 27Postponed or conditional surrender1. The executing judicial authority may, after deciding to execute the arrest warrant, postpone the surrender of the requested person so that he or she may be prosecuted in the executing State or, if he or she has already been sentenced, so that he or she may serve, in its territory, a sentence passed for an act other than that referred to in the arrest warrant.2. Instead of postponing the surrender, the executing judicial authority may temporarily surrender the requested person to the issuing State under conditions to be determined by mutual agreement between the executing and the issuing judicial authorities. The agreement shall be made in writing and the conditions shall be binding on all the authorities in the issuing State.Article 28Transit1. Each State shall permit the transit through its territory of a requested person who is being surrendered provided that it has been given information on:(a) the identity and nationality of the person subject to the arrest warrant;(b) the existence of an arrest warrant;(c) the nature and legal classification of the offence;(d) the description of the circumstances of the offence, including the date and place.The State, on behalf of which a declaration has been made in accordance with Article 7(2), to the effect that nationals will not be surrendered or that surrender will be authorised only under certain specified conditions, may, under the same terms, refuse the transit of its nationals through its territory or submit it to the same conditions.2. The Contracting Parties shall notify each other of the authority designated for each State responsible for receiving transit requests and the necessary documents, as well as any other official correspondence relating to transit requests.3. The transit request and the information set out in paragraph 1 may be addressed to the authority designated pursuant to paragraph 2 by any means capable of producing a written record. The State of transit shall notify its decision by the same procedure.4. This Agreement does not apply in the case of transport by air without a scheduled stopover. However, if an unscheduled landing occurs, the issuing State shall provide the authority designated pursuant to paragraph 2 with the information provided for in paragraph 1.5. Where a transit concerns a person who is to be extradited from a third State to a State this Article will apply mutatis mutandis. In particular the expression \"arrest warrant\" as defined by this Agreement shall be deemed to be replaced by \"extradition request\".CHAPTER 3EFFECTS OF THE SURRENDERArticle 29Deduction of the period of detention served in the executing State1. The issuing State shall deduct all periods of detention arising from the execution of an arrest warrant from the total period of detention to be served in the issuing State as a result of a custodial sentence or detention order being passed.2. To that end, all information concerning the duration of the detention of the requested person on the basis of the arrest warrant shall be transmitted by the executing judicial authority or the central authority designated under Article 10 to the issuing judicial authority at the time of the surrender.Article 30Possible prosecution for other offences1. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may notify each other that, for relations of States with other States to which the same notification applies, consent is presumed to have been given for the prosecution, sentencing or detention with a view to the carrying out of a custodial sentence or detention order for an offence committed prior to his or her surrender, other than that for which he or she was surrendered, unless in a particular case the executing judicial authority states otherwise in its decision on surrender.2. Except in the cases referred to in paragraphs 1 and 3, a person surrendered may not be prosecuted, sentenced or otherwise deprived of his or her liberty for an offence committed prior to his or her surrender other than that for which he or she was surrendered.3. Paragraph 2 does not apply in the following cases:(a) when the person having had an opportunity to leave the territory of the State to which he or she has been surrendered has not done so within 45 days of his or her final discharge, or has returned to that territory after leaving it;(b) the offence is not punishable by a custodial sentence or detention order;(c) the criminal proceedings do not give rise to the application of a measure restricting personal liberty;(d) when the person could be liable to a penalty or a measure not involving the deprivation of liberty, in particular a financial penalty or a measure in lieu thereof, even if the penalty or measure may give rise to a restriction of his or her personal liberty;(e) when the person consented to be surrendered, where appropriate at the same time as he or she renounced the speciality rule, in accordance with Article 16;(f) when the person, after his/her surrender, has expressly renounced entitlement to the speciality rule with regard to specific offences preceding his/her surrender. Renunciation shall be given before the competent judicial authorities of the issuing State and shall be recorded in accordance with that State's domestic law. The renunciation shall be drawn up in such a way as to make clear that the person has given it voluntarily and in full awareness of the consequences. To that end, the person shall have the right to legal counsel;(g) where the executing judicial authority which surrendered the person gives its consent in accordance with paragraph 4.4. A request for consent shall be submitted to the executing judicial authority, accompanied by the information mentioned in Article 11(1) and a translation as referred to in Article 11(2). Consent shall be given when the offence for which it is requested is itself subject to surrender in accordance with the provisions of this Agreement. Consent shall be refused on the grounds referred to in Article 4 and otherwise may be refused only on the grounds referred to in Articles 5, or 6(2) and 7(2). The decision shall be taken no later than 30 days after receipt of the request. For the situations mentioned in Article 8 the issuing State must give the guarantees provided for therein.Article 31Surrender or subsequent extradition1. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may notify each other that, for relations of States with other States to which the same notification applies, the consent for the surrender of a person to a State other than the executing State pursuant to an arrest warrant issued for an offence committed prior to his or her surrender is presumed to have been given, unless in a particular case the executing judicial authority states otherwise in its decision on surrender.2. In any case, a person who has been surrendered to the issuing State pursuant to an arrest warrant may, without the consent of the executing State, be surrendered to a State other than the executing State pursuant to an arrest warrant issued for any offence committed prior to his or her surrender in the following cases:(a) where the requested person, having had an opportunity to leave the territory of the State to which he or she has been surrendered, has not done so within 45 days of his final discharge, or has returned to that territory after leaving it;(b) where the requested person consents to be surrendered to a State other than the executing State pursuant to an arrest warrant. Consent shall be given before the competent judicial authorities of the issuing State and shall be recorded in accordance with that State's national law. It shall be drawn up in such a way as to make clear that the person concerned has given it voluntarily and in full awareness of the consequences. To that end, the requested person shall have the right to legal counsel;(c) where the requested person is not subject to the speciality rule, in accordance with Article 30(3)(a), (e), (f) and (g).3. The executing judicial authority consents to the surrender to another State according to the following rules:(a) the request for consent shall be submitted in accordance with Article 12, accompanied by the information mentioned in Article 11(1) and a translation as stated in Article 11(2);(b) consent shall be given when the offence for which it is requested is itself subject to surrender in accordance with the provisions of this Agreement;(c) the decision shall be taken no later than 30 days after receipt of the request;(d) consent shall be refused on the grounds referred to in Article 4 and otherwise may be refused only on the grounds referred to in Articles 5 or 6(2) and 7(2).For the situations referred to in Article 8, the issuing State must give the guarantees provided for therein.4. Notwithstanding paragraph 1, a person who has been surrendered pursuant to an arrest warrant shall not be extradited to a third State without the consent of the competent authority of the State which surrendered the person. Such consent shall be given in accordance with the Conventions by which that State is bound, as well as with its domestic law.Article 32Handing over of property1. At the request of the issuing judicial authority or on its own initiative, the executing judicial authority shall, in accordance with its national law, seize and hand over property which:(a) may be required as evidence; or(b) has been acquired by the requested person as a result of the offence.2. The property referred to in paragraph 1 shall be handed over even if the arrest warrant cannot be carried out owing to the death or escape of the requested person.3. If the property referred to in paragraph 1 is liable to seizure or confiscation in the territory of the executing State, the latter may, if the property is needed in connection with pending criminal proceedings, temporarily retain it or hand it over to the issuing State, on condition that it is returned.4. Any rights which the executing State or third parties may have acquired in the property referred to in paragraph 1 shall be preserved. Where such rights exist, the issuing State shall return the property without charge to the executing State as soon as the criminal proceedings have been terminated.Article 33Expenses1. Expenses incurred in the territory of the executing State for the execution of an arrest warrant shall be borne by that State.2. All other expenses shall be borne by the issuing State.CHAPTER 4GENERAL AND FINAL PROVISIONSArticle 34Relation to other legal instruments1. Without prejudice to their application in relations between States and third States, this Agreement shall, from its entry into force, replace the corresponding provisions of the following conventions applicable in the field of extradition in relations between Norway and Iceland, on the one hand, and Member States, on the other hand:(a) the European Convention on Extradition of 13 December 1957, its additional protocol of 15 October 1975, its second additional protocol of 17 March 1978, and the European Convention on the suppression of terrorism of 27 January 1977 as far as extradition is concerned as amended by the 2003 Protocol once it will enter into force;(b) Title III, Chapter 4 of the Convention of 19 June 1990 implementing the Schengen Agreement of 14 June 1985 on the gradual abolition of checks at common borders;(c) Schengen-relevant provisions of the 1995 and 1996 EU Extradition Conventions to the extent that they are in force.2. States may continue to apply bilateral or multilateral agreements or arrangements in force when this Agreement is concluded in so far as such agreements or arrangements allow the objectives of this Agreement to be extended or enlarged and help to simplify or facilitate further the procedures for surrender of persons who are the subject of an arrest warrant. The Contracting Parties shall notify each other of any such agreements or arrangements.3. States may conclude bilateral or multilateral agreements or arrangements after this Agreement has come into force in so far as such agreements or arrangements allow the prescriptions of this Agreement to be extended or enlarged and help to simplify or facilitate further the procedures for surrender of persons who are the subject of an arrest warrant, in particular by fixing time limits shorter than those fixed in Article 20, by extending the list of offences laid down in Article 3(4), by further limiting the grounds for refusal set out in Articles 4 and 5, or by lowering the threshold provided for in Article 3(1) or (4).The agreements and arrangements referred to in the first subparagraph may in no case affect relations with States which are not parties to them.The Contracting Parties shall also notify each other of any such new agreement or arrangement as referred to in the first subparagraph, within three months of signing it.4. Where the conventions or agreements referred to in paragraph 1 apply to the territories of States or to territories for whose external relations a State is responsible to which this Agreement does not apply, these instruments shall continue to govern the relations existing between those territories and the other States.Article 35Transitional provision1. Extradition requests received before the date of entry into force of this Agreement will continue to be governed by existing instruments relating to extradition. Requests received after that date will be governed by this Agreement.2. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may, at the time of the notification provided for in Article 38(1), make a statement indicating that, as executing State, the State will continue to apply the extradition system applicable before the entry into force of this Agreement in relation to acts committed before a date which it specifies. The date in question may not be later than the entry into force of this Agreement. The said statement may be withdrawn at any time.Article 36Dispute settlementAny dispute between either Iceland or Norway and a Member State of the European Union regarding the interpretation or the application of this Agreement may be referred by a party to the dispute to a meeting of representatives of the governments of the Member States of the European Union and of Iceland and Norway, with a view to its settlement within six months.Article 37Case lawThe Contracting Parties, in order to achieve the objective of arriving at as uniform an application and interpretation as possible of the provisions of this Agreement, shall keep under constant review the development of the case law of the Court of Justice of the European Communities, as well as the development of the case law of the competent courts of Iceland and Norway relating to these provisions and to those of similar surrender instruments. To this end a mechanism shall be set up to ensure regular mutual transmission of such case law.Article 38Notifications, declarations, entry into force1. The Contracting Parties shall notify each other of the completion of the procedures required to express their consent to be bound by this Agreement.2. When giving their notification under paragraph 1 the Contracting Parties shall make any of the notifications or declarations provided for in Articles 5(2), 9(3), 28(2) and 34(2) of this Agreement and may make any of the notifications or declarations provided for in Articles 3(4), 6(2), 7(2), 10(1), 11(2), 16(4), 20(5), 30(1), 31(1) and 35(2) of this Agreement. The declarations or notifications referred to in Articles 3(4), 10(1) and 11(2) may be made at any time. The declarations or notifications referred to in Articles 9(3) and 28(2) may be modified, and those referred to in Articles 5(2), 6(2), 7(2), 10(1), 16(4), 20(5), 34(2) and 35(2) withdrawn, at all times.3. Where the European Union makes such declarations or notifications it shall indicate for which of its Member States the declaration applies.4. This Agreement shall enter into force on the first day of the third month following the day on which the Secretary-General of the Council of the European Union has established that all formal requirements concerning the expression of the consent by the Contracting Parties to this Agreement have been fulfilled.Article 39AccessionAccession by new Member States to the European Union shall create rights and obligations under the present Agreement between those new Member States and Iceland and Norway.Article 40Common reviewThe Contracting Parties agree to carry out a common review of this Agreement no later than five years after its entry into force, and in particular of the declarations made under Articles 3(4), 6(2), 7(2) and 20(5) of this Agreement. Where the declarations referred to in Article 7(2) are not renewed, they shall expire five years after the entry into force of this Agreement. The review shall in particular address the practical implementation, interpretation and development of the Agreement and may also include issues such as the consequences of further development of the European Union relating to the subject matter of this Agreement.Article 41Termination1. This Agreement may be terminated by the Contracting Parties. In the event of termination by either Iceland or Norway, this Agreement shall remain in force between the European Union and the Contracting Party for which it has not been terminated.2. Termination of this Agreement pursuant to paragraph 1 shall take effect six months after the deposit of the notification of termination. Procedures for complying with requests for surrender still pending at that date shall be completed in conformity with the provisions of this Agreement.Article 42Depository1. The Secretary General of the Council of the European Union shall act as the depository of this Agreement.2. The depository shall make public information on any notification or declaration made concerning this Agreement.Done at Vienna on 28 June 2006 in one single copy in the Icelandic, Norwegian, Czech, Danish, Dutch, German, English, Estonian, French, Finnish, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Slovak, Slovenian, Spanish and Swedish languages, each version being equally authentic.Fyrir h\u00f6nd Evr\u00f3pusambandsinsFor Den europeiske unionPor la Uni\u00f3n EuropeaZa Evropskou uniiFor den Europ\u00e6iske UnionF\u00fcr die Europ\u00e4ische UnionEuroopa Liidu nimel\u0393\u03b9\u03b1 \u03c4\u03b7\u03bd \u0395\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03ae \u0388\u03bd\u03c9\u03c3\u03b7For the European UnionPour l'Union europ\u00e9enneThar ceann an Aontais EorpaighPer l'Unione europeaEiropas Savien\u012bbas v\u0101rd\u0101Europos S\u0105jungos varduAz Eur\u00f3pai Uni\u00f3 r\u00e9sz\u00e9r\u0151lG\u0127all-Unjoni EwropeaVoor de Europese UnieW imieniu Unii EuropejskiejPela Uni\u00e3o EuropeiaZa Eur\u00f3psku \u00faniuZa Evropsko unijoEuroopan unionin puolestaP\u00e5 Europeiska unionens v\u00e4gnar+++++ TIFF +++++Fyrir h\u00f6nd l\u00fd\u00f0veldisins \u00cdslandsFor Republikken IslandPor la Rep\u00fablica de IslandiaZa Islandskou republikuFor Republikken IslandF\u00fcr die Republik IslandIslandi Vabariigi nimel\u0393\u03b9\u03b1 \u03c4\u03b7 \u0394\u03b7\u03bc\u03bf\u03ba\u03c1\u03b1\u03c4\u03af\u03b1 \u03c4\u03b7\u03c2 \u0399\u03c3\u03bb\u03b1\u03bd\u03b4\u03af\u03b1\u03c2For the Republic of IcelandPour la R\u00e9publique d'IslandeThar ceann Phoblacht na h\u00cdoslainnePer la Repubblica d'IslandaIslandes Republikas v\u0101rd\u0101Islandijos Respublikos varduAz Izlandi K\u00f6zt\u00e1rsas\u00e1g r\u00e9sz\u00e9r\u0151lGhar-Repubblika ta' l-I\u017clandaVoor de Republiek IjslandW imieniu Republiki IslandiiPela Rep\u00fablica da Isl\u00e2ndiaZa Islandsk\u00fa republikuZa Republiko IslandijoIslannin tasavallan puolestaP\u00e5 Republiken Islands v\u00e4gnar+++++ TIFF +++++Fyrir h\u00f6nd Konungsr\u00edkisins NoregsFor Kongeriket NorgePor el Reino de NoruegaZa Norsk\u00e9 kr\u00e1lovstviFor Kongeriget NorgeF\u00fcr das K\u00f6nigreich NorwegenNorra Kuningriigi nimel\u0393\u03b9\u03b1 \u03c4\u03bf \u0392\u03b1\u03c3\u03af\u03bb\u03b5\u03b9\u03bf \u03c4\u03b7\u03c2 \u039d\u03bf\u03c1\u03b2\u03b7\u03b3\u03af\u03b1\u03c2For the Kingdom of NorwayPour le Royaume de Norv\u00e8geThar ceann R\u00edocht na hIoruaPer il Regno di NorvegiaNorv\u0113\u0123ijas Karalistes v\u0101rd\u0101Norvegijos Karalyst\u0117s varduA Norv\u00e9g Kir\u00e1lys\u00e1g r\u00e9sz\u00e9r\u0151lGhar-Renju tan-Norve\u0121jaVoor het Koninkrijk NoorwegenW imieniu Kr\u00f3lestwa NorwegiiPelo Reino da NoruegaZa N\u00f3rske kr\u00e1\u013eovstvoZa Kraljevino Norve\u0161koNorjan kuningaskunnan puolestaP\u00e5 Konungariket Norges v\u00e4gnar+++++ TIFF +++++--------------------------------------------------", "summary": "Surrender procedure between EU Member States and Iceland and Norway Surrender procedure between EU Member States and Iceland and Norway SUMMARY OF: Agreement between the EU and Iceland and Norway on the surrender procedure between the EU Member States and Iceland and Norway Decision 2006/697/EC on the signing of the Agreement between the EU and Iceland and Norway on the surrender procedure between the EU Member States and Iceland and Norway Decision 2014/835/EU on the conclusion of the Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway WHAT IS THE AIM OF THE AGREEMENT AND DECISIONS? The object of this agreement is to improve judicial cooperation in criminal matters between the EU Member States and Iceland and Norway. It aims to set up a surrender procedure* to speed up the transfer of suspected and convicted persons and to ensure sufficient controls on carrying out European arrest warrants. The parties to the agreement undertake to respect fundamental rights, to protect personal data and to refuse to surrender any person based on discriminatory reasons. They also express their mutual confidence in their legal systems and their ability to guarantee a fair trial. Decision 2006/697/EC approves the signing of the agreement on behalf of the EU, subject to its being concluded. Decision 2014/835/EU approves the agreement on the surrender procedure between the Member States and Iceland and Norway. KEY POINTS Arrest warrant An arrest warrant may be issued for offences punishable by a custodial sentence or detention order of at least 12 months, or 4 months where a sentence has already been passed or a detention order made. The arrest warrant containing details of the identity of the requested person, the issuing authority, the sentence and the nature of the offence is transmitted as soon as the requested person is found, and communicated to the Schengen Information System (SIS) or, if this is not possible, to Interpol. If the person consents to the surrender, the final decision to carry out the arrest warrant should be taken within 10 days after consent has been given. In other cases, the final decision on carrying out the arrest warrant should be taken within 60 days after the arrest. In some circumstances this can be extended by 30 days. Double criminality For offences punishable by a custodial sentence of at least 3 years, the parties can declare that they do not require the condition of double criminality* for 32 categories of offences as long as the offences carry a sentence of at least 3 years. These offences include: participation in a criminal organisation, terrorism, trafficking in human beings, sexual exploitation of children and child pornography, illicit trafficking in narcotic drugs and psychotropic substances, illicit trafficking in weapons, munitions and explosives, corruption, fraud, including that affecting the EU\u2019s financial interests, laundering of the proceeds of crime, counterfeiting currency, including of the euro, computer-related crime, environmental crime, including illicit trafficking in endangered animal species and in endangered plant species and varieties, facilitation of unauthorised entry and residence, murder, grievous bodily injury, illicit trade in human organs and tissue, kidnapping, illegal restraint and hostage-taking, racism and xenophobia, organised or armed robbery, illicit trafficking in cultural goods, including antiques and works of art, swindling, racketeering and extortion, counterfeiting and piracy of products, forgery of administrative documents and trafficking therein, forgery of means of payment, illicit trafficking in hormonal substances and other growth promoters, illicit trafficking in nuclear or radioactive materials, trafficking in stolen vehicles, rape, arson, crimes within the jurisdiction of the International Criminal Court, unlawful seizure of aircraft/ships, sabotage. Grounds for not executing an arrest warrant Mandatory grounds for refusal: Judicial authorities will refuse to carry out an arrest warrant if: the offence is covered by an amnesty; the person has already been tried for the same offence and has served or is serving their sentence; the person cannot be held criminally responsible because of their age. Optional grounds for refusal: Countries can refuse to carry out an arrest warrant if: the acts are not an offence in the country being asked to carry out the arrest warrant, that is, the executing state (except in relation to taxes, duties, customs and exchange); the person is being prosecuted in the executing state for the same offence; the state has passed a final judgement in respect of the same offence, which prevents further proceedings; the authorities in the executing state have decided not to prosecute the person or have halted proceedings; the criminal prosecution or punishment of the requested person is barred by statute in the executing state; the requested person is a national or resident of the executing state and that state undertakes to carry out the sentence; the offences were committed outside the issuing state or its laws do not permit prosecution for those offences. Fundamental rights The agreement states that it respects fundamental rights and fundamental legal principles laid down in the European Convention on Human Rights, or Article 6 of the Treaty on European Union. It also states it should not be interpreted as prohibiting the refusal to surrender a person: where the arrest warrant may have been issued on the grounds of sex, race, religion, ethnic origin, nationality, language, political opinions or sexual orientation; where that person\u2019s position may be prejudiced for any of these reasons. Political offence exception The executing state may not refuse to carry out an arrest warrant on the grounds that it regards the offence as political. The parties can, however, limit this option to offences covered by Directive (EU) 2017/541 on combating terrorism and by Articles 1 and 2 of the European Convention on the Suppression of Terrorism, 1977. Surrender procedure The arrested person must be informed at the time of the arrest of the contents of the warrant, the possibility of consenting to surrender to the issuing authority, and the right to be assisted by legal counsel and an interpreter. The person may remain in detention or be released provisionally, provided that measures are taken to prevent absconding. The hearing is conducted under the laws of the executing state and in agreed conditions. The person can choose to voluntarily consent to surrender, if this is with full knowledge of the consequences. The person should be surrendered where possible within 10 days of the decision to execute the warrant or of the surrender date agreed between the authorities. The executing authority seizes and hands over property that may serve as evidence or that has been acquired by the person as a result of the offence. The parties will permit the transit through their territory of a person being surrendered, provided that they have full information about the warrant. Expenses All expenses are borne by the issuing state, except those incurred in the territory of the executing state in connection with carrying out an arrest warrant. Disputes and review Any disputes should be referred to a meeting of representatives of the governments of the parties and settled within 6 months. The parties will keep under review the development of the case-law of the Court of Justice of the European Union and of the case-law of the competent courts of Iceland and Norway, and will carry out a review of the agreement no later than 5 years after it comes into force. DATE OF ENTRY INTO FORCE The agreement entered into force on 1 November 2019. BACKGROUND For more information, see: European Arrest Warrant (European e-Justice). KEY TERMS Surrender procedure: a procedure that allows a country to surrender a person to another country for the purpose of conducting a criminal prosecution or executing a custodial sentence or spell in detention. Double criminality: in extradition/surrender law, a feature by which countries can refuse to extradite/surrender persons if the alleged criminal offence in the country requesting the extradition/surrender would not be an offence in the country being asked to carry out the extradition/surrender. MAIN DOCUMENTS Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway (OJ L 292, 21.10.2006, pp. 2-19) Council Decision 2006/697/EC of 27 June 2006 on the signing of the Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway (OJ L 292, 21.10.2006, p.1) Council Decision 2014/835/EU of 27 November 2014 on the conclusion of the Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway (OJ L 343, 28.11.2014, pp. 1-2) RELATED DOCUMENTS Notice concerning the entry into force of the Surrender Agreement between the European Union, Iceland and Norway (OJ L 230, 6.9.2019, p. 1) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, pp. 6-21) last update 06.05.2021"}
{"article": "3.12.2007 EN Official Journal of the European Union L 315/14 REGULATION (EC) No 1371/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 October 2007 on rail passengers\u2019 rights and obligations THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty, in the light of the joint text approved by the Conciliation Committee on 31 July 2007 (3), Whereas: (1) In the framework of the common transport policy, it is important to safeguard users\u2019 rights for rail passengers and to improve the quality and effectiveness of rail passenger services in order to help increase the share of rail transport in relation to other modes of transport. (2) The Commission\u2019s communication \u2018Consumer Policy Strategy 2002-2006\u2019 (4) sets the aim of achieving a high level of consumer protection in the field of transport in accordance with Article 153(2) of the Treaty. (3) Since the rail passenger is the weaker party to the transport contract, passengers\u2019 rights in this respect should be safeguarded. (4) Users\u2019 rights to rail services include the receipt of information regarding the service both before and during the journey. Whenever possible, railway undertakings and ticket vendors should provide this information in advance and as soon as possible. (5) More detailed requirements regarding the provision of travel information will be set out in the technical specifications for interoperability (TSIs) referred to in Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the conventional rail system (5). (6) Strengthening of the rights of rail passengers should build on the existing system of international law on this subject contained in Appendix A \u2014 Uniform rules concerning the Contract for International Carriage of Passengers and Luggage by Rail (CIV) to the Convention concerning International Carriage by Rail (COTIF) of 9 May 1980, as modified by the Protocol for the modification of the Convention concerning International Carriage by Rail of 3 June 1999 (1999 Protocol). However, it is desirable to extend the scope of this Regulation and protect not only international passengers but domestic passengers too. (7) Railway undertakings should cooperate to facilitate the transfer of rail passengers from one operator to another by the provision of through tickets, whenever possible. (8) The provision of information and tickets for rail passengers should be facilitated by the adaptation of computerised systems to a common specification. (9) The further implementation of travel information and reservation systems should be executed in accordance with the TSIs. (10) Rail passenger services should benefit citizens in general. Consequently, disabled persons and persons with reduced mobility, whether caused by disability, age or any other factor, should have opportunities for rail travel comparable to those of other citizens. Disabled persons and persons with reduced mobility have the same right as all other citizens to free movement, freedom of choice and to non-discrimination. Inter alia, special attention should be given to the provision of information to disabled persons and persons with reduced mobility concerning the accessibility of rail services, access conditions of rolling stock and the facilities on board. In order to provide passengers with sensory impairment with the best information on delays, visual and audible systems should be used, as appropriate. Disabled persons and persons with reduced mobility should be enabled to buy tickets on board a train without extra charges. (11) Railway undertakings and station managers should take into account the needs of disabled persons and persons with reduced mobility, through compliance with the TSI for persons with reduced mobility, so as to ensure that, in accordance with Community public procurement rules, all buildings and rolling stock are made accessible through the progressive elimination of physical obstacles and functional hindrances when acquiring new material or carrying out construction or major renovation work. (12) Railway undertakings should be obliged to be insured, or to make equivalent arrangements, for their liability to rail passengers in the event of accident. The minimum amount of insurance for railway undertakings should be the subject of future review. (13) Strengthened rights of compensation and assistance in the event of delay, missed connection or cancellation of a service should lead to greater incentives for the rail passenger market, to the benefit of passengers. (14) It is desirable that this Regulation create a system of compensation for passengers in the case of delay which is linked to the liability of the railway undertaking, on the same basis as the international system provided by the COTIF and in particular appendix CIV thereto relating to passengers\u2019 rights. (15) Where a Member State grants railway undertakings an exemption from the provisions of this Regulation, it should encourage railway undertakings, in consultation with organisations representing passengers, to put in place arrangements for compensation and assistance in the event of major disruption to a rail passenger service. (16) It is also desirable to relieve accident victims and their dependants of short-term financial concerns in the period immediately after an accident. (17) It is in the interests of rail passengers that adequate measures be taken, in agreement with public authorities, to ensure their personal security at stations as well as on board trains. (18) Rail passengers should be able to submit a complaint to any railway undertaking involved regarding the rights and obligations conferred by this Regulation, and be entitled to receive a response within a reasonable period of time. (19) Railway undertakings should define, manage and monitor service quality standards for rail passenger services. (20) The contents of this Regulation should be reviewed in respect of the adjustment of financial amounts for inflation and in respect of information and service quality requirements in the light of market developments as well as in the light of the effects on service quality of this Regulation. (21) This Regulation should be without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (6). (22) Member States should lay down penalties applicable to infringements of this Regulation and ensure that these penalties are applied. The penalties, which might include the payment of compensation to the person in question, should be effective, proportionate and dissuasive. (23) Since the objectives of this Regulation, namely the development of the Community\u2019s railways and the introduction of passenger rights, cannot be sufficiently achieved by the Member States, and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (24) It is an aim of this Regulation to improve rail passenger services within the Community. Therefore, Member States should be able to grant exemptions for services in regions where a significant part of the service is operated outside the Community. (25) Railway undertakings in some Member States may experience difficulty in applying the entirety of the provisions of this Regulation on its entry into force. Therefore, Member States should be able to grant temporary exemptions from the application of the provisions of this Regulation to long-distance domestic rail passenger services. The temporary exemption should, however, not apply to the provisions of this Regulation that grant disabled persons or persons with reduced mobility access to travel by rail, nor to the right of those wishing to purchase tickets for travel by rail to do so without undue difficulty, nor to the provisions on railway undertakings\u2019 liability in respect of passengers and their luggage, the requirement that undertakings be adequately insured, and the requirement that those undertakings take adequate measures to ensure passengers\u2019 personal security in railway stations and on trains and to manage risk. (26) Urban, suburban and regional rail passenger services are different in character from long-distance services. Therefore, with the exception of certain provisions which should apply to all rail passenger services throughout the Community, Member States should be able to grant exemptions from the application of the provisions of this Regulation to urban, suburban and regional rail passenger services. (27) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7). (28) In particular, the Commission should be empowered to adopt implementing measures. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, or to supplement it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes rules as regards the following: (a) the information to be provided by railway undertakings, the conclusion of transport contracts, the issuing of tickets and the implementation of a Computerised Information and Reservation System for Rail Transport, (b) the liability of railway undertakings and their insurance obligations for passengers and their luggage, (c) the obligations of railway undertakings to passengers in cases of delay, (d) the protection of, and assistance to, disabled persons and persons with reduced mobility travelling by rail, (e) the definition and monitoring of service quality standards, the management of risks to the personal security of passengers and the handling of complaints, and (f) general rules on enforcement. Article 2 Scope 1. This Regulation shall apply to all rail journeys and services throughout the Community provided by one or more railway undertakings licensed in accordance with Council Directive 95/18/EC of 19 June 1995 on the licensing of railway undertakings (8). 2. This Regulation does not apply to railway undertakings and transport services which are not licensed under Directive 95/18/EC. 3. On the entry into force of this Regulation, Articles 9, 11, 12, 19, 20(1) and 26 shall apply to all rail passenger services throughout the Community. 4. With the exception of the provisions set out in paragraph 3, a Member State may, on a transparent and non-discriminatory basis, grant an exemption for a period no longer than five years, which may be renewed twice for a maximum period of five years on each occasion, from the application of the provisions of this Regulation to domestic rail passenger services. 5. With the exception of the provisions set out in paragraph 3 of this Article, a Member State may exempt from the application of the provisions of this Regulation urban, suburban and regional rail passenger services. In order to distinguish between urban, suburban and regional rail passenger services, Member States shall apply the definitions contained in Council Directive 91/440/EEC of 29 July 1991 on the development of the Community\u2019s railways (9). In applying these definitions, Member States shall take into account the following criteria: distance, frequency of services, number of scheduled stops, rolling stock employed, ticketing schemes, fluctuations in passenger numbers between services in peak and off-peak periods, train codes and timetables. 6. For a maximum period of five years, a Member State may, on a transparent and non-discriminatory basis, grant an exemption, which may be renewed, from the application of the provisions of this Regulation to particular services or journeys because a significant part of the rail passenger service, including at least one scheduled station stop, is operated outside the Community. 7. Member States shall inform the Commission of exemptions granted pursuant to paragraphs 4, 5 and 6. The Commission shall take appropriate action if such an exemption is deemed not to be in accordance with the provisions of this Article. No later than 3 December 2014, the Commission shall submit to the European Parliament and the Council a report on exemptions granted pursuant to paragraphs 4, 5 and 6. Article 3 Definitions For the purposes of this Regulation the following definitions shall apply: 1. \u2018railway undertaking\u2019 means a railway undertaking as defined in Article 2 of Directive 2001/14/EC (10), and any other public or private undertaking the activity of which is to provide transport of goods and/or passengers by rail on the basis that the undertaking must ensure traction; this also includes undertakings which provide traction only; 2. \u2018carrier\u2019 means the contractual railway undertaking with whom the passenger has concluded the transport contract or a series of successive railway undertakings which are liable on the basis of this contract; 3. \u2018substitute carrier\u2019 means a railway undertaking, which has not concluded a transport contract with the passenger, but to whom the railway undertaking party to the contract has entrusted, in whole or in part, the performance of the transport by rail; 4. \u2018infrastructure manager\u2019 means any body or undertaking that is responsible in particular for establishing and maintaining railway infrastructure, or a part thereof, as defined in Article 3 of Directive 91/440/EEC, which may also include the management of infrastructure control and safety systems; the functions of the infrastructure manager on a network or part of a network may be allocated to different bodies or undertakings; 5. \u2018station manager\u2019 means an organisational entity in a Member State, which has been made responsible for the management of a railway station and which may be the infrastructure manager; 6. \u2018tour operator\u2019 means an organiser or retailer, other than a railway undertaking, within the meaning of Article 2, points (2) and (3) of Directive 90/314/EEC (11); 7. \u2018ticket vendor\u2019 means any retailer of rail transport services concluding transport contracts and selling tickets on behalf of a railway undertaking or for its own account; 8. \u2018transport contract\u2019 means a contract of carriage for reward or free of charge between a railway undertaking or a ticket vendor and the passenger for the provision of one or more transport services; 9. \u2018reservation\u2019 means an authorisation, on paper or in electronic form, giving entitlement to transportation subject to previously confirmed personalised transport arrangements; 10. \u2018through ticket\u2019 means a ticket or tickets representing a transport contract for successive railway services operated by one or several railway undertakings; 11. \u2018domestic rail passenger service\u2019 means a rail passenger service which does not cross a border of a Member State; 12. \u2018delay\u2019 means the time difference between the time the passenger was scheduled to arrive in accordance with the published timetable and the time of his or her actual or expected arrival; 13. \u2018travel pass\u2019 or \u2018season ticket\u2019 means a ticket for an unlimited number of journeys which provides the authorised holder with rail travel on a particular route or network during a specified period; 14. \u2018Computerised Information and Reservation System for Rail Transport (CIRSRT)\u2019 means a computerised system containing information about rail services offered by railway undertakings; the information stored in the CIRSRT on passenger services shall include information on: (a) schedules and timetables of passenger services; (b) availability of seats on passenger services; (c) fares and special conditions; (d) accessibility of trains for disabled persons and persons with reduced mobility; (e) facilities through which reservations may be made or tickets or through tickets may be issued to the extent that some or all of these facilities are made available to users; 15. \u2018disabled person\u2019 or \u2018person with reduced mobility\u2019 means any person whose mobility when using transport is reduced due to any physical disability (sensory or locomotory, permanent or temporary), intellectual disability or impairment, or any other cause of disability, or as a result of age, and whose situation needs appropriate attention and adaptation to his or her particular needs of the service made available to all passengers; 16. \u2018General Conditions of Carriage\u2019 means the conditions of the carrier in the form of general conditions or tariffs legally in force in each Member State and which have become, by the conclusion of the contract of carriage, an integral part of it; 17. \u2018vehicle\u2019 means a motor vehicle or a trailer carried on the occasion of the carriage of passengers. CHAPTER II TRANSPORT CONTRACT, INFORMATION AND TICKETS Article 4 Transport contract Subject to the provisions of this Chapter, the conclusion and performance of a transport contract and the provision of information and tickets shall be governed by the provisions of Title II and Title III of Annex I. Article 5 Bicycles Railway undertakings shall enable passengers to bring bicycles on to the train, where appropriate for a fee, if they are easy to handle, if this does not adversely affect the specific rail service, and if the rolling-stock so permits. Article 6 Exclusion of waiver and stipulation of limits 1. Obligations towards passengers pursuant to this Regulation may not be limited or waived, notably by a derogation or restrictive clause in the transport contract. 2. Railway undertakings may offer contract conditions more favourable for the passenger than the conditions laid down in this Regulation. Article 7 Obligation to provide information concerning discontinuation of services Railway undertakings or, where appropriate, competent authorities responsible for a public service railway contract shall make public by appropriate means, and before their implementation, decisions to discontinue services. Article 8 Travel information 1. Without prejudice to Article 10, railway undertakings and ticket vendors offering transport contracts on behalf of one or more railway undertakings shall provide the passenger, upon request, with at least the information set out in Annex II, Part I in relation to the journeys for which a transport contract is offered by the railway undertaking concerned. Ticket vendors offering transport contracts on their own account, and tour operators, shall provide this information where available. 2. Railway undertakings shall provide the passenger during the journey with at least the information set out in Annex II, Part II. 3. The information referred to in paragraphs 1 and 2 shall be provided in the most appropriate format. Particular attention shall be paid in this regard to the needs of people with auditory and/or visual impairment. Article 9 Availability of tickets, through tickets and reservations 1. Railway undertakings and ticket vendors shall offer, where available, tickets, through tickets and reservations. 2. Without prejudice to paragraph 4, railway undertakings shall distribute tickets to passengers via at least one of the following points of sale: (a) ticket offices or selling machines; (b) telephone, the Internet or any other widely available information technology; (c) on board trains. 3. Without prejudice to paragraphs 4 and 5, railway undertakings shall distribute tickets for services provided under public service contracts via at least one of the following points of sale: (a) ticket offices or selling machines; (b) on board trains. 4. Railway undertakings shall offer the possibility to obtain tickets for the respective service on board the train, unless this is limited or denied on grounds relating to security or antifraud policy or compulsory train reservation or reasonable commercial grounds. 5. Where there is no ticket office or selling machine in the station of departure, passengers shall be informed at the station: (a) of the possibility of purchasing tickets via telephone or the Internet or on board the train, and of the procedure for such purchase; (b) of the nearest railway station or place at which ticket offices and/or selling machines are available. Article 10 Travel information and reservation systems 1. In order to provide the information and to issue tickets referred to in this Regulation, railway undertakings and ticket vendors shall make use of CIRSRT, to be established by the procedures referred to in this Article. 2. The technical specifications for interoperability (TSIs) referred to in Directive 2001/16/EC shall be applied for the purposes of this Regulation. 3. The Commission shall, on a proposal to be submitted by the European Railway Agency (ERA), adopt the TSI of telematics applications for passengers by 3 December 2010. The TSI shall make possible the provision of the information, set out in Annex II, and the issuing of tickets as governed by this Regulation. 4. Railway undertakings shall adapt their CIRSRT according to the requirements set out in the TSI in accordance with a deployment plan set out in that TSI. 5. Subject to the provisions of Directive 95/46/EC, no railway undertaking or ticket vendor shall disclose personal information on individual bookings to other railway undertakings and/or ticket vendors. CHAPTER III LIABILITY OF RAILWAY UNDERTAKINGS FOR PASSENGERS AND THEIR LUGGAGE Article 11 Liability for passengers and luggage Subject to the provisions of this Chapter, and without prejudice to applicable national law granting passengers further compensation for damages, the liability of railway undertakings in respect of passengers and their luggage shall be governed by Chapters I, III and IV of Title IV, Title VI and Title VII of Annex I. Article 12 Insurance 1. The obligation set out in Article 9 of Directive 95/18/EC as far as it relates to liability for passengers shall be understood as requiring a railway undertaking to be adequately insured or to make equivalent arrangements for cover of its liabilities under this Regulation. 2. The Commission shall submit to the European Parliament and the Council a report on the setting of a minimum amount of insurance for railway undertakings by 3 December 2010. If appropriate, that report shall be accompanied by suitable proposals or recommendations on this matter. Article 13 Advance payments 1. If a passenger is killed or injured, the railway undertaking as referred to in Article 26(5) of Annex I shall without delay, and in any event not later than fifteen days after the establishment of the identity of the natural person entitled to compensation, make such advance payments as may be required to meet immediate economic needs on a basis proportional to the damage suffered. 2. Without prejudice to paragraph 1, an advance payment shall not be less than EUR 21 000 per passenger in the event of death. 3. An advance payment shall not constitute recognition of liability and may be offset against any subsequent sums paid on the basis of this Regulation but is not returnable, except in the cases where damage was caused by the negligence or fault of the passenger or where the person who received the advance payment was not the person entitled to compensation. Article 14 Contestation of liability Even if the railway undertaking contests its responsibility for physical injury to a passenger whom it conveys, it shall make every reasonable effort to assist a passenger claiming compensation for damage from third parties. CHAPTER IV DELAYS, MISSED CONNECTIONS AND CANCELLATIONS Article 15 Liability for delays, missed connections and cancellations Subject to the provisions of this Chapter, the liability of railway undertakings in respect of delays, missed connections and cancellations shall be governed by Chapter II of Title IV of Annex I. Article 16 Reimbursement and re-routing Where it is reasonably to be expected that the delay in the arrival at the final destination under the transport contract will be more than 60 minutes, the passenger shall immediately have the choice between: (a) reimbursement of the full cost of the ticket, under the conditions by which it was paid, for the part or parts of his or her journey not made and for the part or parts already made if the journey is no longer serving any purpose in relation to the passenger\u2019s original travel plan, together with, when relevant, a return service to the first point of departure at the earliest opportunity. The payment of the reimbursement shall be made under the same conditions as the payment for compensation referred to in Article 17; or (b) continuation or re-routing, under comparable transport conditions, to the final destination at the earliest opportunity; or (c) continuation or re-routing, under comparable transport conditions, to the final destination at a later date at the passenger\u2019s convenience. Article 17 Compensation of the ticket price 1. Without losing the right of transport, a passenger may request compensation for delays from the railway undertaking if he or she is facing a delay between the places of departure and destination stated on the ticket for which the ticket has not been reimbursed in accordance with Article 16. The minimum compensations for delays shall be as follows: (a) 25 % of the ticket price for a delay of 60 to 119 minutes, (b) 50 % of the ticket price for a delay of 120 minutes or more. Passengers who hold a travel pass or season ticket and who encounter recurrent delays or cancellations during its period of validity may request adequate compensation in accordance with the railway undertaking\u2019s compensation arrangements. These arrangements shall state the criteria for determining delay and for the calculation of the compensation. Compensation for delay shall be calculated in relation to the price which the passenger actually paid for the delayed service. Where the transport contract is for a return journey, compensation for delay on either the outward or the return leg shall be calculated in relation to half of the price paid for the ticket. In the same way the price for a delayed service under any other form of transport contract allowing travelling several subsequent legs shall be calculated in proportion to the full price. The calculation of the period of delay shall not take into account any delay that the railway undertaking can demonstrate as having occurred outside the territories in which the Treaty establishing the European Community is applied. 2. The compensation of the ticket price shall be paid within one month after the submission of the request for compensation. The compensation may be paid in vouchers and/or other services if the terms are flexible (in particular regarding the validity period and destination). The compensation shall be paid in money at the request of the passenger. 3. The compensation of the ticket price shall not be reduced by financial transaction costs such as fees, telephone costs or stamps. Railway undertakings may introduce a minimum threshold under which payments for compensation will not be paid. This threshold shall not exceed EUR 4. 4. The passenger shall not have any right to compensation if he is informed of a delay before he buys a ticket, or if a delay due to continuation on a different service or re-routing remains below 60 minutes. Article 18 Assistance 1. In the case of a delay in arrival or departure, passengers shall be kept informed of the situation and of the estimated departure time and estimated arrival time by the railway undertaking or by the station manager as soon as such information is available. 2. In the case of any delay as referred to in paragraph 1 of more than 60 minutes, passengers shall also be offered free of charge: (a) meals and refreshments in reasonable relation to the waiting time, if they are available on the train or in the station, or can reasonably be supplied; (b) hotel or other accommodation, and transport between the railway station and place of accommodation, in cases where a stay of one or more nights becomes necessary or an additional stay becomes necessary, where and when physically possible; (c) if the train is blocked on the track, transport from the train to the railway station, to the alternative departure point or to the final destination of the service, where and when physically possible. 3. If the railway service cannot be continued anymore, railway undertakings shall organise as soon as possible alternative transport services for passengers. 4. Railway undertakings shall, at the request of the passenger, certify on the ticket that the rail service has suffered a delay, led to a missed connection or that it has been cancelled, as the case might be. 5. In applying paragraphs 1, 2 and 3, the operating railway undertaking shall pay particular attention to the needs of disabled persons and persons with reduced mobility and any accompanying persons. CHAPTER V DISABLED PERSONS AND PERSONS WITH REDUCED MOBILITY Article 19 Right to transport 1. Railway undertakings and station managers shall, with the active involvement of representative organisations of disabled persons and persons with reduced mobility, establish, or shall have in place, non-discriminatory access rules for the transport of disabled persons and persons with reduced mobility. 2. Reservations and tickets shall be offered to disabled persons and persons with reduced mobility at no additional cost. A railway undertaking, ticket vendor or tour operator may not refuse to accept a reservation from, or issue a ticket to, a disabled person or a person with reduced mobility, or require that such person be accompanied by another person, unless this is strictly necessary in order to comply with the access rules referred to in paragraph 1. Article 20 Information to disabled persons and persons with reduced mobility 1. Upon request, a railway undertaking, a ticket vendor or a tour operator shall provide disabled persons and persons with reduced mobility with information on the accessibility of rail services and on the access conditions of rolling stock in accordance with the access rules referred to in Article 19(1) and shall inform disabled persons and persons with reduced mobility about facilities on board. 2. When a railway undertaking, ticket vendor and/or tour operator exercises the derogation provided for in Article 19(2), it shall upon request inform in writing the disabled person or person with reduced mobility concerned of its reasons for doing so within five working days of the refusal to make the reservation or to issue the ticket or the imposition of the condition of being accompanied. Article 21 Accessibility 1. Railway undertakings and station managers shall, through compliance with the TSI for persons with reduced mobility, ensure that the station, platforms, rolling stock and other facilities are accessible to disabled persons and persons with reduced mobility. 2. In the absence of accompanying staff on board a train or of staff at a station, railway undertakings and station managers shall make all reasonable efforts to enable disabled persons or persons with reduced mobility to have access to travel by rail. Article 22 Assistance at railway stations 1. On departure from, transit through or arrival at, a staffed railway station of a disabled person or a person with reduced mobility, the station manager shall provide assistance free of charge in such a way that that person is able to board the departing service, or to disembark from the arriving service for which he or she purchased a ticket, without prejudice to the access rules referred to in Article 19(1). 2. Member States may provide for a derogation from paragraph 1 in the case of persons travelling on services which are the subject of a public service contract awarded in conformity with Community law, on condition that the competent authority has put in place alternative facilities or arrangements guaranteeing an equivalent or higher level of accessibility of transport services. 3. In unstaffed stations, railway undertakings and station managers shall ensure that easily accessible information is displayed in accordance with the access rules referred to in Article 19(1) regarding the nearest staffed stations and directly available assistance for disabled persons and persons with reduced mobility. Article 23 Assistance on board Without prejudice to the access rules as referred to in Article 19(1), railway undertakings shall provide disabled persons and persons with reduced mobility assistance free of charge on board a train and during boarding and disembarking from a train. For the purposes of this Article, assistance on board shall consist of all reasonable efforts to offer assistance to a disabled person or a person with reduced mobility in order to allow that person to have access to the same services in the train as other passengers, should the extent of the person\u2019s disability or reduced mobility not allow him or her to have access to those services independently and in safety. Article 24 Conditions on which assistance is provided Railway undertakings, station managers, ticket vendors and tour operators shall cooperate in order to provide assistance to disabled persons and persons with reduced mobility in line with Articles 22 and 23 in accordance with the following points: (a) assistance shall be provided on condition that the railway undertaking, the station manager, the ticket vendor or the tour operator with which the ticket was purchased is notified of the person\u2019s need for such assistance at least 48 hours before the assistance is needed. Where the ticket permits multiple journeys, one notification shall be sufficient provided that adequate information on the timing of subsequent journeys is provided; (b) railway undertakings, station managers, ticket vendors and tour operators shall take all measures necessary for the reception of notifications; (c) if no notification is made in accordance with point (a), the railway undertaking and the station manager shall make all reasonable efforts to provide assistance in such a way that the disabled person or person with reduced mobility may travel; (d) without prejudice to the powers of other entities regarding areas located outside the railway station premises, the station manager or any other authorised person shall designate points, within and outside the railway station, at which disabled persons and persons with reduced mobility can announce their arrival at the railway station and, if need be, request assistance; (e) assistance shall be provided on condition that the disabled person or person with reduced mobility present him or herself at the designated point at a time stipulated by the railway undertaking or station manager providing such assistance. Any time stipulated shall not be more than 60 minutes before the published departure time or the time at which all passengers are asked to check in. If no time is stipulated by which the disabled person or person with reduced mobility is required to present him or herself, the person shall present him or herself at the designated point at least 30 minutes before the published departure time or the time at which all passengers are asked to check in. Article 25 Compensation in respect of mobility equipment or other specific equipment If the railway undertaking is liable for the total or partial loss of, or damage to, mobility equipment or other specific equipment used by disabled persons or persons with reduced mobility, no financial limit shall be applicable. CHAPTER VI SECURITY, COMPLAINTS AND QUALITY OF SERVICE Article 26 Personal security of passengers In agreement with public authorities, railway undertakings, infrastructure managers and station managers shall take adequate measures in their respective fields of responsibility and adapt them to the level of security defined by the public authorities to ensure passengers\u2019 personal security in railway stations and on trains and to manage risks. They shall cooperate and exchange information on best practices concerning the prevention of acts, which are likely to deteriorate the level of security. Article 27 Complaints 1. Railway undertakings shall set up a complaint handling mechanism for the rights and obligations covered in this Regulation. The railway undertaking shall make its contact details and working language(s) widely known to passengers. 2. Passengers may submit a complaint to any railway undertaking involved. Within one month, the addressee of the complaint shall either give a reasoned reply or, in justified cases, inform the passenger by what date within a period of less than three months from the date of the complaint a reply can be expected. 3. The railway undertaking shall publish in the annual report referred to in Article 28 the number and categories of received complaints, processed complaints, response time and possible improvement actions undertaken. Article 28 Service quality standards 1. Railway undertakings shall define service quality standards and implement a quality management system to maintain service quality. The service quality standards shall at least cover the items listed in Annex III. 2. Railway undertakings shall monitor their own performance as reflected in the service quality standards. Railway undertakings shall each year publish a report on their service quality performance together with their annual report. The reports on service quality performance shall be published on the Internet website of the railway undertakings. In addition, these reports shall be made available on the Internet website of the ERA. CHAPTER VII INFORMATION AND ENFORCEMENT Article 29 Information to passengers about their rights 1. When selling tickets for journeys by rail, railway undertakings, station managers and tour operators shall inform passengers of their rights and obligations under this Regulation. In order to comply with this information requirement, railway undertakings, station managers and tour operators may use a summary of the provisions of this Regulation prepared by the Commission in all official languages of the European Union institutions and made available to them. 2. Railway undertakings and station managers shall inform passengers in an appropriate manner, at the station and on the train, of the contact details of the body or bodies designated by Member States pursuant to Article 30. Article 30 Enforcement 1. Each Member State shall designate a body or bodies responsible for the enforcement of this Regulation. Each body shall take the measures necessary to ensure that the rights of passengers are respected. Each body shall be independent in its organisation, funding decisions, legal structure and decision-making of any infrastructure manager, charging body, allocation body or railway undertaking. Member States shall inform the Commission of the body or bodies designated in accordance with this paragraph and of its or their respective responsibilities. 2. Each passenger may complain to the appropriate body designated under paragraph 1, or to any other appropriate body designated by a Member State, about an alleged infringement of this Regulation. Article 31 Cooperation between enforcement bodies Enforcement bodies as referred to in Article 30 shall exchange information on their work and decision-making principles and practice for the purpose of coordinating their decision-making principles across the Community. The Commission shall support them in this task. CHAPTER VIII FINAL PROVISIONS Article 32 Penalties Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify those rules and measures to the Commission by 3 June 2010 and shall notify it without delay of any subsequent amendment affecting them. Article 33 Annexes Measures designed to amend non-essential elements of this Regulation by adapting the Annexes thereto, except Annex I, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(2). Article 34 Amending provisions 1. Measures designed to amend non-essential elements of this Regulation by supplementing it and necessary for the implementation of Articles 2, 10 and 12 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(2). 2. Measures designed to amend non-essential elements of this Regulation by adjusting the financial amounts referred to therein, other than in Annex I, in light of inflation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(2). Article 35 Committee procedure 1. The Commission shall be assisted by the Committee instituted by Article 11a of Directive 91/440/EEC. 2. Where reference is made to this paragraph, Articles 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 36 Report The Commission shall report to the European Parliament and the Council on the implementation and the results of this Regulation by 3 December 2012, and in particular on the service quality standards. The report shall be based on information to be provided pursuant to this Regulation and to Article 10b of Directive 91/440/EEC. The report shall be accompanied where necessary by appropriate proposals. Article 37 Entry into force This Regulation shall enter into force 24 months after the date of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 23 October 2007. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President M. LOBO ANTUNES (1) OJ C 221, 8.9.2005, p. 8. (2) OJ C 71, 22.3.2005, p. 26. (3) Opinion of the European Parliament of 28 September 2005 (OJ C 227 E, 21.9.2006, p. 490), Council Common Position of 24 July 2006 (OJ C 289 E, 28.11.2006, p. 1), Position of the European Parliament of 18 January 2007 (not yet published in the Official Journal), Legislative Resolution of the European Parliament of 25 September 2007 and Council Decision of 26 September 2007. (4) OJ C 137, 8.6.2002, p. 2. (5) OJ L 110, 20.4.2001, p. 1. Directive as last amended by Commission Directive 2007/32/EC (OJ L 141, 2.6.2007, p. 63). (6) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). (7) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (8) OJ L 143, 27.6.1995, p. 70. Directive as last amended by Directive 2004/49/EC of the European Parliament and of the Council (OJ L 164, 30.4.2004, p. 44). (9) OJ L 237, 24.8.1991, p. 25. Directive as last amended by Directive 2006/103/EC (OJ L 363, 20.12.2006, p. 344). (10) Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure (OJ L 75, 15.3.2001, p. 29). Directive as last amended by Directive 2004/49/EC. (11) Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (OJ L 158, 23.6.1990, p. 59). ANNEX I Extract from Uniform Rules concerning the contract for international carriage of passengers and luggage by rail (CIV) Appendix A to the Convention Concerning International Carriage by Rail (COTIF) of 9 May 1980, as modified by the Protocol for the modification of the Convention Concerning International Carriage by Rail of 3 June 1999 TITLE II CONCLUSION AND PERFORMANCE OF THE CONTRACT OF CARRIAGE Article 6 Contract of carriage 1. By the contract of carriage the carrier shall undertake to carry the passenger as well as, where appropriate, luggage and vehicles to the place of destination and to deliver the luggage and vehicles at the place of destination. 2. The contract of carriage must be confirmed by one or more tickets issued to the passenger. However, subject to Article 9 the absence, irregularity or loss of the ticket shall not affect the existence or validity of the contract which shall remain subject to these Uniform Rules. 3. The ticket shall be prima facie evidence of the conclusion and the contents of the contract of carriage. Article 7 Ticket 1. The General Conditions of Carriage shall determine the form and content of tickets as well as the language and characters in which they are to be printed and made out. 2. The following, at least, must be entered on the ticket: (a) the carrier or carriers; (b) a statement that the carriage is subject, notwithstanding any clause to the contrary, to these Uniform Rules; this may be indicated by the acronym CIV; (c) any other statement necessary to prove the conclusion and contents of the contract of carriage and enabling the passenger to assert the rights resulting from this contract. 3. The passenger must ensure, on receipt of the ticket, that it has been made out in accordance with his instructions. 4. The ticket shall be transferable if it has not been made out in the passenger\u2019s name and if the journey has not begun. 5. The ticket may be established in the form of electronic data registration, which can be transformed into legible written symbols. The procedure used for the registration and treatment of data must be equivalent from the functional point of view, particularly so far as concerns the evidential value of the ticket represented by those data. Article 8 Payment and refund of the carriage charge 1. Subject to a contrary agreement between the passenger and the carrier, the carriage charge shall be payable in advance. 2. The General Conditions of Carriage shall determine under what conditions a refund of the carriage charge shall be made. Article 9 Right to be carried. Exclusion from carriage 1. The passenger must, from the start of his journey, be in possession of a valid ticket and produce it on the inspection of tickets. The General Conditions of Carriage may provide: (a) that a passenger who does not produce a valid ticket must pay, in addition to the carriage charge, a surcharge; (b) that a passenger who refuses to pay the carriage charge or the surcharge upon demand may be required to discontinue his journey; (c) if and under what conditions a refund of the surcharge shall be made. 2. The General Conditions of Carriage may provide that passengers who: (a) present a danger for safety and the good functioning of the operations or for the safety of other passengers, (b) inconvenience other passengers in an intolerable manner, shall be excluded from carriage or may be required to discontinue their journey and that such persons shall not be entitled to a refund of their carriage charge or of any charge for the carriage of registered luggage they may have paid. Article 10 Completion of administrative formalities The passenger must comply with the formalities required by customs or other administrative authorities. Article 11 Cancellation and late running of trains. Missed connections The carrier must, where necessary, certify on the ticket that the train has been cancelled or the connection missed. TITLE III CARRIAGE OF HAND LUGGAGE, ANIMALS, REGISTERED LUGGAGE AND VEHICLES Chapter I Common provisions Article 12 Acceptable articles and animals 1. The passenger may take with him articles which can be handled easily (hand luggage) and also live animals in accordance with the General Conditions of Carriage. Moreover, the passenger may take with him cumbersome articles in accordance with the special provisions, contained in the General Conditions of Carriage. Articles and animals likely to annoy or inconvenience passengers or cause damage shall not be allowed as hand luggage. 2. The passenger may consign articles and animals as registered luggage in accordance with the General Conditions of Carriage. 3. The carrier may allow the carriage of vehicles on the occasion of the carriage of passengers in accordance with special provisions, contained in the General Conditions of Carriage. 4. The carriage of dangerous goods as hand luggage, registered luggage as well as in or on vehicles which, in accordance with this Title are carried by rail, must comply with the Regulation concerning the Carriage of Dangerous Goods by Rail (RID). Article 13 Examination 1. When there is good reason to suspect a failure to observe the conditions of carriage, the carrier shall have the right to examine whether the articles (hand luggage, registered luggage, vehicles including their loading) and animals carried comply with the conditions of carriage, unless the laws and prescriptions of the State in which the examination would take place prohibit such examination. The passenger must be invited to attend the examination. If he does not appear or cannot be reached, the carrier must require the presence of two independent witnesses. 2. If it is established that the conditions of carriage have not been respected, the carrier can require the passenger to pay the costs arising from the examination. Article 14 Completion of administrative formalities The passenger must comply with the formalities required by customs or other administrative authorities when, on being carried, he has articles (hand luggage, registered luggage, vehicles including their loading) or animals carried. He shall be present at the inspection of these articles save where otherwise provided by the laws and prescriptions of each State. Chapter II Hand luggage and animals Article 15 Supervision It shall be the passenger\u2019s responsibility to supervise the hand luggage and animals that he takes with him. Chapter III Registered luggage Article 16 Consignment of registered luggage 1. The contractual obligations relating to the forwarding of registered luggage must be established by a luggage registration voucher issued to the passenger. 2. Subject to Article 22 the absence, irregularity or loss of the luggage registration voucher shall not affect the existence or the validity of the agreements concerning the forwarding of the registered luggage, which shall remain subject to these Uniform Rules. 3. The luggage registration voucher shall be prima facie evidence of the registration of the luggage and the conditions of its carriage. 4. Subject to evidence to the contrary, it shall be presumed that when the carrier took over the registered luggage it was apparently in a good condition, and that the number and the mass of the items of luggage corresponded to the entries on the luggage registration voucher. Article 17 Luggage registration voucher 1. The General Conditions of Carriage shall determine the form and content of the luggage registration voucher as well as the language and characters in which it is to be printed and made out. Article 7(5) shall apply mutatis mutandis. 2. The following, at least, must be entered on the luggage registration voucher: (a) the carrier or carriers; (b) a statement that the carriage is subject, notwithstanding any clause to the contrary, to these Uniform Rules; this may be indicated by the acronym CIV; (c) any other statement necessary to prove the contractual obligations relating to the forwarding of the registered luggage and enabling the passenger to assert the rights resulting from the contract of carriage. 3. The passenger must ensure, on receipt of the luggage registration voucher, that it has been made out in accordance with his instructions. Article 18 Registration and carriage 1. Save where the General Conditions of Carriage otherwise provide, luggage shall be registered only on production of a ticket valid at least as far as the destination of the luggage. In other respects the registration of luggage shall be carried out in accordance with the prescriptions in force at the place of consignment. 2. When the General Conditions of Carriage provide that luggage may be accepted for carriage without production of a ticket, the provisions of these Uniform Rules determining the rights and obligations of the passenger in respect of his registered luggage shall apply mutatis mutandis to the consignor of registered luggage. 3. The carrier can forward the registered luggage by another train or by another mode of transport and by a different route from that taken by the passenger. Article 19 Payment of charges for the carriage of registered luggage Subject to a contrary agreement between the passenger and the carrier, the charge for the carriage of registered luggage shall be payable on registration. Article 20 Marking of registered luggage The passenger must indicate on each item of registered luggage in a clearly visible place, in a sufficiently durable and legible manner: (a) his name and address; (b) the place of destination. Article 21 Right to dispose of registered luggage 1. If circumstances permit and if customs requirements or the requirements of other administrative authorities are not thereby contravened, the passenger can request luggage to be handed back at the place of consignment on surrender of the luggage registration voucher and, if the General Conditions of Carriage so require, on production of the ticket. 2. The General Conditions of Carriage may contain other provisions concerning the right to dispose of registered luggage, in particular modifications of the place of destination and the possible financial consequences to be borne by the passenger. Article 22 Delivery 1. Registered luggage shall be delivered on surrender of the luggage registration voucher and, where appropriate, on payment of the amounts chargeable against the consignment. The carrier shall be entitled, but not obliged, to examine whether the holder of the voucher is entitled to take delivery. 2. It shall be equivalent to delivery to the holder of the luggage registration voucher if, in accordance with the prescriptions in force at the place of destination: (a) the luggage has been handed over to the customs or octroi authorities at their premises or warehouses, when these are not subject to the carrier\u2019s supervision; (b) live animals have been handed over to third parties. 3. The holder of the luggage registration voucher may require delivery of the luggage at the place of destination as soon as the agreed time and, where appropriate, the time necessary for the operations carried out by customs or other administrative authorities, has elapsed. 4. Failing surrender of the luggage registration voucher, the carrier shall only be obliged to deliver the luggage to the person proving his right thereto; if the proof offered appears insufficient, the carrier may require security to be given. 5. Luggage shall be delivered at the place of destination for which it has been registered. 6. The holder of a luggage registration voucher whose luggage has not been delivered may require the day and time to be endorsed on the voucher when he requested delivery in accordance with paragraph 3. 7. The person entitled may refuse to accept the luggage if the carrier does not comply with his request to carry out an examination of the registered luggage in order to establish alleged damage. 8. In all other respects delivery of luggage shall be carried out in accordance with the prescriptions in force at the place of destination. Chapter IV Vehicles Article 23 Conditions of carriage The special provisions governing the carriage of vehicles, contained in the General Conditions of Carriage, shall specify in particular the conditions governing acceptance for carriage, registration, loading and carriage, unloading and delivery as well as the obligations of the passenger. Article 24 Carriage voucher 1. The contractual obligations relating to the carriage of vehicles must be established by a carriage voucher issued to the passenger. The carriage voucher may be integrated into the passenger\u2019s ticket. 2. The special provisions governing the carriage of vehicles, contained in the General Conditions of Carriage, shall determine the form and content of the carriage voucher as well as the language and the characters in which it is to be printed and made out. Article 7(5) shall apply mutatis mutandis. 3. The following, at least, must be entered on the carriage voucher: (a) the carrier or carriers; (b) a statement that the carriage is subject, notwithstanding any clause to the contrary, to these Uniform Rules; this may be indicated by the acronym CIV; (c) any other statement necessary to prove the contractual obligations relating to the carriage of vehicles and enabling the passenger to assert the rights resulting from the contract of carriage. 4. The passenger must ensure, on receipt of the carriage voucher, that it has been made out in accordance with his instructions. Article 25 Applicable law Subject to the provisions of this Chapter, the provisions of Chapter III relating to the carriage of luggage shall apply to vehicles. TITLE IV LIABILITY OF THE CARRIER Chapter I Liability in case of death of, or personal injury to, passengers Article 26 Basis of liability 1. The carrier shall be liable for the loss or damage resulting from the death of, personal injuries to, or any other physical or mental harm to, a passenger, caused by an accident arising out of the operation of the railway and happening while the passenger is in, entering or alighting from railway vehicles whatever the railway infrastructure used. 2. The carrier shall be relieved of this liability (a) if the accident has been caused by circumstances not connected with the operation of the railway and which the carrier, in spite of having taken the care required in the particular circumstances of the case, could not avoid and the consequences of which he was unable to prevent; (b) to the extent that the accident is due to the fault of the passenger; (c) if the accident is due to the behaviour of a third party which the carrier, in spite of having taken the care required in the particular circumstances of the case, could not avoid and the consequences of which he was unable to prevent; another undertaking using the same railway infrastructure shall not be considered as a third party; the right of recourse shall not be affected. 3. If the accident is due to the behaviour of a third party and if, in spite of that, the carrier is not entirely relieved of his liability in accordance with paragraph 2, letter c), he shall be liable in full up to the limits laid down in these Uniform Rules but without prejudice to any right of recourse which the carrier may have against the third party. 4. These Uniform Rules shall not affect any liability which may be incurred by the carrier in cases not provided for in paragraph 1. 5. If carriage governed by a single contract of carriage is performed by successive carriers, the carrier bound pursuant to the contract of carriage to provide the service of carriage in the course of which the accident happened shall be liable in case of death of, and personal injuries to, passengers. When this service has not been provided by the carrier, but by a substitute carrier, the two carriers shall be jointly and severally liable in accordance with these Uniform Rules. Article 27 Damages in case of death 1. In case of death of the passenger the damages shall comprise: (a) any necessary costs following the death, in particular those of transport of the body and the funeral expenses; (b) if death does not occur at once, the damages provided for in Article 28. 2. If, through the death of the passenger, persons whom he had, or would have had, a legal duty to maintain are deprived of their support, such persons shall also be compensated for that loss. Rights of action for damages of persons whom the passenger was maintaining without being legally bound to do so, shall be governed by national law. Article 28 Damages in case of personal injury In case of personal injury or any other physical or mental harm to the passenger the damages shall comprise: (a) any necessary costs, in particular those of treatment and of transport; (b) compensation for financial loss, due to total or partial incapacity to work, or to increased needs. Article 29 Compensation for other bodily harm National law shall determine whether and to what extent the carrier must pay damages for bodily harm other than that for which there is provision in Articles 27 and 28. Article 30 Form and amount of damages in case of death and personal injury 1. The damages under Article 27(2) and Article 28(b) must be awarded in the form of a lump sum. However, if national law permits payment of an annuity, the damages shall be awarded in that form if so requested by the injured passenger or by the persons entitled referred to in Article 27(2). 2. The amount of damages to be awarded pursuant to paragraph 1 shall be determined in accordance with national law. However, for the purposes of these Uniform Rules, the upper limit per passenger shall be set at 175 000 units of account as a lump sum or as an annual annuity corresponding to that sum, where national law provides for an upper limit of less than that amount. Article 31 Other modes of transport 1. Subject to paragraph 2, the provisions relating to the liability of the carrier in case of death of, or personal injury to, passengers shall not apply to loss or damage arising in the course of carriage which, in accordance with the contract of carriage, was not carriage by rail. 2. However, where railway vehicles are carried by ferry, the provisions relating to liability in case of death of, or personal injury to, passengers shall apply to loss or damage referred to in Article 26(1) and Article 33(1), caused by an accident arising out of the operation of the railway and happening while the passenger is in, entering or alighting from the said vehicles. 3. When, because of exceptional circumstances, the operation of the railway is temporarily suspended and the passengers are carried by another mode of transport, the carrier shall be liable pursuant to these Uniform Rules. Chapter II Liability in case of failure to keep to the timetable Article 32 Liability in case of cancellation, late running of trains or missed connections 1. The carrier shall be liable to the passenger for loss or damage resulting from the fact that, by reason of cancellation, the late running of a train or a missed connection, his journey cannot be continued the same day, or that a continuation of the journey the same day could not reasonably be required because of given circumstances. The damages shall comprise the reasonable costs of accommodation as well as the reasonable costs occasioned by having to notify persons expecting the passenger. 2. The carrier shall be relieved of this liability, when the cancellation, late running or missed connection is attributable to one of the following causes: (a) circumstances not connected with the operation of the railway which the carrier, in spite of having taken the care required in the particular circumstances of the case, could not avoid and the consequences of which he was unable to prevent; (b) fault on the part of the passenger; or (c) the behaviour of a third party which the carrier, in spite of having taken the care required in the particular circumstances of the case, could not avoid and the consequences of which he was unable to prevent; another undertaking using the same railway infrastructure shall not be considered as a third party; the right of recourse shall not be affected. 3. National law shall determine whether and to what extent the carrier must pay damages for harm other than that provided for in paragraph 1. This provision shall be without prejudice to Article 44. Chapter III Liability in respect of hand luggage, animals, registered luggage and vehicles SECTION 1 Hand luggage and animals Article 33 Liability 1. In case of death of, or personal injury to, passengers the carrier shall also be liable for the loss or damage resulting from the total or partial loss of, or damage to, articles which the passenger had on him or with him as hand luggage; this shall apply also to animals which the passenger had brought with him. Article 26 shall apply mutatis mutandis. 2. In other respects, the carrier shall not be liable for the total or partial loss of, or damage to, articles, hand luggage or animals the supervision of which is the responsibility of the passenger in accordance with Article 15, unless this loss or damage is caused by the fault of the carrier. The other Articles of Title IV, with exception of Article 51, and Title VI shall not apply in this case. Article 34 Limit of damages in case of loss of or damage to articles When the carrier is liable under Article 33(1), he must pay compensation up to a limit of 1 400 units of account per passenger. Article 35 Exclusion of liability The carrier shall not be liable to the passenger for loss or damage arising from the fact that the passenger does not conform to the formalities required by customs or other administrative authorities. SECTION 2 Registered luggage Article 36 Basis of liability 1. The carrier shall be liable for loss or damage resulting from the total or partial loss of, or damage to, registered luggage between the time of taking over by the carrier and the time of delivery as well as from delay in delivery. 2. The carrier shall be relieved of this liability to the extent that the loss, damage or delay in delivery was caused by a fault of the passenger, by an order given by the passenger other than as a result of the fault of the carrier, by an inherent defect in the registered luggage or by circumstances which the carrier could not avoid and the consequences of which he was unable to prevent. 3. The carrier shall be relieved of this liability to the extent that the loss or damage arises from the special risks inherent in one or more of the following circumstances: (a) the absence or inadequacy of packing; (b) the special nature of the luggage; (c) the consignment as luggage of articles not acceptable for carriage. Article 37 Burden of proof 1. The burden of proving that the loss, damage or delay in delivery was due to one of the causes specified in Article 36(2) shall lie on the carrier. 2. When the carrier establishes that, having regard to the circumstances of a particular case, the loss or damage could have arisen from one or more of the special risks referred to in Article 36(3), it shall be presumed that it did so arise. The person entitled shall, however, have the right to prove that the loss or damage was not attributable either wholly or in part to one of those risks. Article 38 Successive carriers If carriage governed by a single contract is performed by several successive carriers, each carrier, by the very act of taking over the luggage with the luggage registration voucher or the vehicle with the carriage voucher, shall become a party to the contract of carriage in respect of the forwarding of luggage or the carriage of vehicles, in accordance with the terms of the luggage registration voucher or of the carriage voucher and shall assume the obligations arising therefrom. In such a case each carrier shall be responsible for the carriage over the entire route up to delivery. Article 39 Substitute carrier 1. Where the carrier has entrusted the performance of the carriage, in whole or in part, to a substitute carrier, whether or not in pursuance of a right under the contract of carriage to do so, the carrier shall nevertheless remain liable in respect of the entire carriage. 2. All the provisions of these Uniform Rules governing the liability of the carrier shall apply also to the liability of the substitute carrier for the carriage performed by him. Articles 48 and 52 shall apply if an action is brought against the servants or any other persons whose services the substitute carrier makes use of for the performance of the carriage. 3. Any special agreement under which the carrier assumes obligations not imposed by these Uniform Rules or waives rights conferred by these Uniform Rules shall be of no effect in respect of the substitute carrier who has not accepted it expressly and in writing. Whether or not the substitute carrier has accepted it, the carrier shall nevertheless remain bound by the obligations or waivers resulting from such special agreement. 4. Where and to the extent that both the carrier and the substitute carrier are liable, their liability shall be joint and several. 5. The aggregate amount of compensation payable by the carrier, the substitute carrier and their servants and other persons whose services they make use of for the performance of the carriage shall not exceed the limits provided for in these Uniform Rules. 6. This Article shall not prejudice rights of recourse which may exist between the carrier and the substitute carrier. Article 40 Presumption of loss 1. The person entitled may, without being required to furnish further proof, consider an item of luggage as lost when it has not been delivered or placed at his disposal within 14 days after a request for delivery has been made in accordance with Article 22(3). 2. If an item of luggage deemed to have been lost is recovered within one year after the request for delivery, the carrier must notify the person entitled if his address is known or can be ascertained. 3. Within thirty days after receipt of a notification referred to in paragraph 2, the person entitled may require the item of luggage to be delivered to him. In that case he must pay the charges in respect of carriage of the item from the place of consignment to the place where delivery is effected and refund the compensation received less, where appropriate, any costs included therein. Nevertheless he shall retain his rights to claim compensation for delay in delivery provided for in Article 43. 4. If the item of luggage recovered has not been claimed within the period stated in paragraph 3 or if it is recovered more than one year after the request for delivery, the carrier shall dispose of it in accordance with the laws and prescriptions in force at the place where the item of luggage is situated. Article 41 Compensation for loss 1. In case of total or partial loss of registered luggage, the carrier must pay, to the exclusion of all other damages: (a) if the amount of the loss or damage suffered is proved, compensation equal to that amount but not exceeding 80 units of account per kilogram of gross mass short or 1 200 units of account per item of luggage; (b) if the amount of the loss or damage suffered is not established, liquidated damages of 20 units of account per kilogram of gross mass short or 300 units of account per item of luggage. The method of compensation, by kilogram missing or by item of luggage, shall be determined by the General Conditions of Carriage. 2. The carrier must in addition refund the charge for the carriage of luggage and the other sums paid in relation to the carriage of the lost item as well as the customs duties and excise duties already paid. Article 42 Compensation for damage 1. In case of damage to registered luggage, the carrier must pay compensation equivalent to the loss in value of the luggage, to the exclusion of all other damages. 2. The compensation shall not exceed: (a) if all the luggage has lost value through damage, the amount which would have been payable in case of total loss; (b) if only part of the luggage has lost value through damage, the amount which would have been payable had that part been lost. Article 43 Compensation for delay in delivery 1. In case of delay in delivery of registered luggage, the carrier must pay in respect of each whole period of 24 hours after delivery has been requested, but subject to a maximum of 14 days: (a) if the person entitled proves that loss or damage has been suffered thereby, compensation equal to the amount of the loss or damage, up to a maximum of 0,80 units of account per kilogram of gross mass of the luggage or 14 units of account per item of luggage, delivered late; (b) if the person entitled does not prove that loss or damage has been suffered thereby, liquidated damages of 0,14 units of account per kilogram of gross mass of the luggage or 2,80 units of account per item of luggage, delivered late. The methods of compensation, by kilogram missing or by item of luggage, shall be determined by the General Conditions of Carriage. 2. In case of total loss of luggage, the compensation provided for in paragraph 1 shall not be payable in addition to that provided for in Article 41. 3. In case of partial loss of luggage, the compensation provided for in paragraph 1 shall be payable in respect of that part of the luggage which has not been lost. 4. In case of damage to luggage not resulting from delay in delivery the compensation provided for in paragraph 1 shall, where appropriate, be payable in addition to that provided for in Article 42. 5. In no case shall the total of compensation provided for in paragraph 1 together with that payable under Articles 41 and 42 exceed the compensation which would be payable in case of total loss of the luggage. SECTION 3 Vehicles Article 44 Compensation for delay 1. In case of delay in loading for a reason attributable to the carrier or delay in delivery of a vehicle, the carrier must, if the person entitled proves that loss or damage has been suffered thereby, pay compensation not exceeding the amount of the carriage charge. 2. If, in case of delay in loading for a reason attributable to the carrier, the person entitled elects not to proceed with the contract of carriage, the carriage charge shall be refunded to him. In addition the person entitled may, if he proves that loss or damage has been suffered as a result of the delay, claim compensation not exceeding the carriage charge. Article 45 Compensation for loss In case of total or partial loss of a vehicle the compensation payable to the person entitled for the loss or damage proved shall be calculated on the basis of the usual value of the vehicle. It shall not exceed 8 000 units of account. A loaded or unloaded trailer shall be considered as a separate vehicle. Article 46 Liability in respect of other articles 1. In respect of articles left inside the vehicle or situated in boxes (e.g. luggage or ski boxes) fixed to the vehicle, the carrier shall be liable only for loss or damage caused by his fault. The total compensation payable shall not exceed 1 400 units of account. 2. So far as concerns articles stowed on the outside of the vehicle, including the boxes referred to in paragraph 1, the carrier shall be liable in respect of articles placed on the outside of the vehicle only if it is proved that the loss or damage results from an act or omission, which the carrier has committed either with intent to cause such a loss or damage or recklessly and with knowledge that such loss or damage would probably result. Article 47 Applicable law Subject to the provisions of this Section, the provisions of Section 2 relating to liability for luggage shall apply to vehicles. Chapter IV Common provisions Article 48 Loss of right to invoke the limits of liability The limits of liability provided for in these Uniform Rules as well as the provisions of national law, which limit the compensation to a fixed amount, shall not apply if it is proved that the loss or damage results from an act or omission, which the carrier has committed either with intent to cause such loss or damage, or recklessly and with knowledge that such loss or damage would probably result. Article 49 Conversion and interest 1. Where the calculation of compensation requires the conversion of sums expressed in foreign currency, conversion shall be at the exchange rate applicable on the day and at the place of payment of the compensation. 2. The person entitled may claim interest on compensation, calculated at five per cent per annum, from the day of the claim provided for in Article 55 or, if no such claim has been made, from the day on which legal proceedings were instituted. 3. However, in the case of compensation payable pursuant to Articles 27 and 28, interest shall accrue only from the day on which the events relevant to the assessment of the amount of compensation occurred, if that day is later than that of the claim or the day when legal proceedings were instituted. 4. In the case of luggage, interest shall only be payable if the compensation exceeds 16 units of account per luggage registration voucher. 5. In the case of luggage, if the person entitled does not submit to the carrier, within a reasonable time allotted to him, the supporting documents required for the amount of the claim to be finally settled, no interest shall accrue between the expiry of the time allotted and the actual submission of such documents. Article 50 Liability in case of nuclear incidents The carrier shall be relieved of liability pursuant to these Uniform Rules for loss or damage caused by a nuclear incident when the operator of a nuclear installation or another person who is substituted for him is liable for the loss or damage pursuant to the laws and prescriptions of a State governing liability in the field of nuclear energy. Article 51 Persons for whom the carrier is liable The carrier shall be liable for his servants and other persons whose services he makes use of for the performance of the carriage, when these servants and other persons are acting within the scope of their functions. The managers of the railway infrastructure on which the carriage is performed shall be considered as persons whose services the carrier makes use of for the performance of the carriage. Article 52 Other actions 1. In all cases where these Uniform Rules shall apply, any action in respect of liability, on whatever grounds, may be brought against the carrier only subject to the conditions and limitations laid down in these Uniform Rules. 2. The same shall apply to any action brought against the servants and other persons for whom the carrier is liable pursuant to Article 51. TITLE V LIABILITY OF THE PASSENGER Article 53 Special principles of liability The passenger shall be liable to the carrier for any loss or damage: (a) resulting from failure to fulfil his obligations pursuant to 1. Articles 10, 14 and 20, 2. the special provisions for the carriage of vehicles, contained in the General Conditions of Carriage, or 3. the Regulation concerning the International Carriage of Dangerous Goods by Rail (RID), or (b) caused by articles and animals that he brings with him, unless he proves that the loss or damage was caused by circumstances that he could not avoid and the consequences of which he was unable to prevent, despite the fact that he exercised the diligence required of a conscientious passenger. This provision shall not affect the liability of the carrier pursuant to Articles 26 and 33(1). TITLE VI ASSERTION OF RIGHTS Article 54 Ascertainment of partial loss or damage 1. When partial loss of, or damage to, an article carried in the charge of the carrier (luggage, vehicles) is discovered or presumed by the carrier or alleged by the person entitled, the carrier must without delay, and if possible in the presence of the person entitled, draw up a report stating, according to the nature of the loss or damage, the condition of the article and, as far as possible, the extent of the loss or damage, its cause and the time of its occurrence. 2. A copy of the report must be supplied free of charge to the person entitled. 3. Should the person entitled not accept the findings in the report, he may request that the condition of the luggage or vehicle and the cause and amount of the loss or damage be ascertained by an expert appointed either by the parties to the contract of carriage or by a court or tribunal. The procedure to be followed shall be governed by the laws and prescriptions of the State in which such ascertainment takes place. Article 55 Claims 1. Claims relating to the liability of the carrier in case of death of, or personal injury to, passengers must be addressed in writing to the carrier against whom an action may be brought. In the case of a carriage governed by a single contract and performed by successive carriers the claims may also be addressed to the first or the last carrier as well as to the carrier having his principal place of business or the branch or agency which concluded the contract of carriage in the State where the passenger is domiciled or habitually resident. 2. Other claims relating to the contract of carriage must be addressed in writing to the carrier specified in Article 56(2) and (3). 3. Documents which the person entitled thinks fit to submit with the claim shall be produced either in the original or as copies, where appropriate, the copies duly certified if the carrier so requires. On settlement of the claim, the carrier may require the surrender of the ticket, the luggage registration voucher and the carriage voucher. Article 56 Carriers against whom an action may be brought 1. An action based on the liability of the carrier in case of death of, or personal injury to, passengers may only be brought against the carrier who is liable pursuant to Article 26(5). 2. Subject to paragraph 4 other actions brought by passengers based on the contract of carriage may be brought only against the first carrier, the last carrier or the carrier having performed the part of carriage on which the event giving rise to the proceedings occurred. 3. When, in the case of carriage performed by successive carriers, the carrier who must deliver the luggage or the vehicle is entered with his consent on the luggage registration voucher or the carriage voucher, an action may be brought against him in accordance with paragraph 2 even if he has not received the luggage or the vehicle. 4. An action for the recovery of a sum paid pursuant to the contract of carriage may be brought against the carrier who has collected that sum or against the carrier on whose behalf it was collected. 5. An action may be brought against a carrier other than those specified in paragraphs 2 and 4 when instituted by way of counter-claim or by way of exception in proceedings relating to a principal claim based on the same contract of carriage. 6. To the extent that these Uniform Rules apply to the substitute carrier, an action may also be brought against him. 7. If the plaintiff has a choice between several carriers, his right to choose shall be extinguished as soon as he brings an action against one of them; this shall also apply if the plaintiff has a choice between one or more carriers and a substitute carrier. Article 58 Extinction of right of action in case of death or personal injury 1. Any right of action by the person entitled based on the liability of the carrier in case of death of, or personal injury to, passengers shall be extinguished if notice of the accident to the passenger is not given by the person entitled, within 12 months of his becoming aware of the loss or damage, to one of the carriers to whom a claim may be addressed in accordance with Article 55(1). Where the person entitled gives oral notice of the accident to the carrier, the carrier shall furnish him with an acknowledgement of such oral notice. 2. Nevertheless, the right of action shall not be extinguished if (a) within the period provided for in paragraph 1 the person entitled has addressed a claim to one of the carriers designated in Article 55(1); (b) within the period provided for in paragraph 1 the carrier who is liable has learned of the accident to the passenger in some other way; (c) notice of the accident has not been given, or has been given late, as a result of circumstances not attributable to the person entitled; (d) the person entitled proves that the accident was caused by fault on the part of the carrier. Article 59 Extinction of right of action arising from carriage of luggage 1. Acceptance of the luggage by the person entitled shall extinguish all rights of action against the carrier arising from the contract of carriage in case of partial loss, damage or delay in delivery. 2. Nevertheless, the right of action shall not be extinguished: (a) in case of partial loss or damage, if 1. the loss or damage was ascertained in accordance with Article 54 before the acceptance of the luggage by the person entitled, 2. the ascertainment which should have been carried out in accordance with Article 54 was omitted solely through the fault of the carrier; (b) in case of loss or damage which is not apparent whose existence is ascertained after acceptance of the luggage by the person entitled, if he 1. asks for ascertainment in accordance with Article 54 immediately after discovery of the loss or damage and not later than three days after the acceptance of the luggage, and 2. in addition, proves that the loss or damage occurred between the time of taking over by the carrier and the time of delivery; (c) in case of delay in delivery, if the person entitled has, within twenty-one days, asserted his rights against one of the carriers specified in Article 56(3); (d) if the person entitled proves that the loss or damage was caused by fault on the part of the carrier. Article 60 Limitation of actions 1. The period of limitation of actions for damages based on the liability of the carrier in case of death of, or personal injury to, passengers shall be: (a) in the case of a passenger, three years from the day after the accident; (b) in the case of other persons entitled, three years from the day after the death of the passenger, subject to a maximum of five years from the day after the accident. 2. The period of limitation for other actions arising from the contract of carriage shall be one year. Nevertheless, the period of limitation shall be two years in the case of an action for loss or damage resulting from an act or omission committed either with the intent to cause such loss or damage, or recklessly and with knowledge that such loss or damage would probably result. 3. The period of limitation provided for in paragraph 2 shall run for actions: (a) for compensation for total loss, from the fourteenth day after the expiry of the period of time provided for in Article 22(3); (b) for compensation for partial loss, damage or delay in delivery, from the day when delivery took place; (c) in all other cases involving the carriage of passengers, from the day of expiry of validity of the ticket. The day indicated for the commencement of the period of limitation shall not be included in the period. 4. [\u2026] 5. [\u2026] 6. Otherwise, the suspension and interruption of periods of limitation shall be governed by national law. TITLE VII RELATIONS BETWEEN CARRIERS Article 61 Apportionment of the carriage charge 1. Any carrier who has collected or ought to have collected a carriage charge must pay to the carriers concerned their respective shares of such a charge. The methods of payment shall be fixed by agreement between the carriers. 2. Article 6(3), Article 16(3) and Article 25 shall also apply to the relations between successive carriers. Article 62 Right of recourse 1. A carrier who has paid compensation pursuant to these Uniform Rules shall have a right of recourse against the carriers who have taken part in the carriage in accordance with the following provisions: (a) the carrier who has caused the loss or damage shall be solely liable for it; (b) when the loss or damage has been caused by several carriers, each shall be liable for the loss or damage he has caused; if such distinction is impossible, the compensation shall be apportioned between them in accordance with letter c); (c) if it cannot be proved which of the carriers has caused the loss or damage, the compensation shall be apportioned between all the carriers who have taken part in the carriage, except those who prove that the loss or damage was not caused by them; such apportionment shall be in proportion to their respective shares of the carriage charge. 2. In the case of insolvency of any one of these carriers, the unpaid share due from him shall be apportioned among all the other carriers who have taken part in the carriage, in proportion to their respective shares of the carriage charge. Article 63 Procedure for recourse 1. The validity of the payment made by the carrier exercising a right of recourse pursuant to Article 62 may not be disputed by the carrier against whom the right to recourse is exercised, when compensation has been determined by a court or tribunal and when the latter carrier, duly served with notice of the proceedings, has been afforded an opportunity to intervene in the proceedings. The court or tribunal seized of the principal action shall determine what time shall be allowed for such notification of the proceedings and for intervention in the proceedings. 2. A carrier exercising his right of recourse must present his claim in one and the same proceedings against all the carriers with whom he has not reached a settlement, failing which he shall lose his right of recourse in the case of those against whom he has not taken proceedings. 3. The court or tribunal shall give its decision in one and the same judgment on all recourse claims brought before it. 4. The carrier wishing to enforce his right of recourse may bring his action in the courts or tribunals of the State on the territory of which one of the carriers participating in the carriage has his principal place of business, or the branch or agency which concluded the contract of carriage. 5. When the action must be brought against several carriers, the plaintiff carrier shall be entitled to choose the court or tribunal in which he will bring the proceedings from among those having competence pursuant to paragraph 4. 6. Recourse proceedings may not be joined with proceedings for compensation taken by the person entitled under the contract of carriage. Article 64 Agreements concerning recourse The carriers may conclude agreements which derogate from Articles 61 and 62. ANNEX II MINIMUM INFORMATION TO BE PROVIDED BY RAILWAY UNDERTAKINGS AND/OR BY TICKET VENDORS Part I: Pre-journey information General conditions applicable to the contract Time schedules and conditions for the fastest trip Time schedules and conditions for the lowest fares Accessibility, access conditions and availability on board of facilities for disabled persons and persons with reduced mobility Accessibility and access conditions for bicycles Availability of seats in smoking and non-smoking, first and second class as well as couchettes and sleeping carriages Any activities likely to disrupt or delay services Availability of on-board services Procedures for reclaiming lost luggage Procedures for the submission of complaints. Part II: Information during the journey On-board services Next station Delays Main connecting services Security and safety issues. ANNEX III MINIMUM SERVICE QUALITY STANDARDS Information and tickets Punctuality of services, and general principles to cope with disruptions to services Cancellations of services Cleanliness of rolling stock and station facilities (air quality in carriages, hygiene of sanitary facilities, etc.) Customer satisfaction survey Complaint handling, refunds and compensation for non-compliance with service quality standards Assistance provided to disabled persons and persons with reduced mobility.", "summary": "Rail passenger rights Rail passenger rights SUMMARY OF: Regulation (EC) No 1371/2007 on rail passengers\u2019 rights and obligations WHAT IS THE AIM OF THE REGULATION? It aims at establishing rights and obligations for rail passengers in order to protect them particularly when travel is disrupted, and to improve the efficiency and attractiveness of rail passenger services. KEY POINTS Scope The regulation concerns all rail journeys and services provided under licence by one or more rail undertakings under Directive 2012/34/EU (see summary on A single railway network for Europe). It does not apply to journeys and services carried out on non-EU countries' territory. An EU country can opt to grant an exemption from most articles of the regulation to domestic rail passenger services for a maximum period of 5 years, which may be renewed twice. It may also exempt urban, suburban and regional rail passenger services from this regulation. Passengers\u2019 rights Rail passengers have the following basic rights: Transport contract and information Passengers should be given clear and accessible information: before the journey, in particular concerning the relevant conditions applicable to the contract, timetables and the fares applied; during the journey, in particular concerning any delays or interruptions to services; concerning procedures for the submission of complaints; The information provided to persons with disabilities and persons with reduced mobility shall be in an accessible format. Delays and cancellations In the case of a delay of more than 60 minutes in the arrival at final destination, passengers have the right to: the reimbursement of the full cost of the ticket for the part of the journey not made; or continuation or re-routing under comparable transport conditions at the earliest opportunity or at a later date at the passengers\u2019 convenience. If passengers do not opt for reimbursement but for continuation of the journey, they may claim a minimum compensation equivalent to: 25% of the ticket price for a delay of 60 to 119 minutes; 50% of the ticket price for a delay of 120 minutes or more. In the case of a delay in arrival or departure of more than 60 minutes, passengers have the right to: receive information on the situation and the estimated departure and arrival time; meals and refreshments within reasonable limits; accommodation where a stay of one or more nights becomes necessary; transport to the railway station or to the alternative departure point or to the final destination if the train is blocked on the track. Persons with disability and reduced mobility The EU rail passenger rights legislation will ensure that persons with disability and reduced mobility can travel in a way that is comparable to other citizens. Thus, the regulation gives them the following rights: the right to non-discriminatory access to transport at no additional charge; upon request, to be provided with information concerning the accessibility of rail services and stations; an assistance free of charge on board trains and at staffed stations (passengers are requested to give 48 hours\u2019 notice of their assistance needs before departure); the right to compensation if the rail undertaking is responsible for the loss or damage of their mobility equipment. Security, complaints and service quality Passengers\u2019 personal security is ensured in trains and stations in cooperation with the public authorities. An effective complaints handling mechanism has to be put in place. Passengers may complain to any rail undertaking involved. The minimum service quality standards for rail undertakings include: passenger information and tickets;punctuality of service and general principles to cope with disruptions;cancellation of services;cleanliness of rolling stock and station facilities;customer satisfaction surveys;complaint handling, refunds and compensation for non-compliance with service quality standards;assistance provided to disabled persons and persons with reduced mobility. Enforcement by EU countries EU countries must designate an independent body or bodies in charge of the enforcement of the regulation. Passengers can submit a complaint to any of these bodies if they feel that their rights have not been respected. EU countries must also set up effective, proportionate and dissuasive sanctions for infringements of the regulation. FROM WHEN DOES THE REGULATION APPLY? It has applied since 3 December 2009. BACKGROUND For more information, see: Passenger rights: rail (European Commission). Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted:Commission Notice Interpretative Guidelines on EU passenger rights regulations in the context of the developing situation with Covid-19 Commission Recommendation (EU) 2020/648 of 13 May 2020 on vouchers offered to passengers and travellers as an alternative to reimbursement for cancelled package travel and transport services in the context of the COVID-19 pandemic MAIN DOCUMENT Regulation (EC) No 1371/2007 of the European Parliament and of the Council of 23 October 2007 on rail passengers\u2019 rights and obligations (OJ L 315, 3.12.2007, pp 14-41) RELATED DOCUMENTS Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (recast) (OJ L 343, 14.12.2012, pp. 32-77) Successive amendments to Directive 2012/34/EU have been incorporated into the original document. This consolidated version is of documentary value only. Communication from the Commission \u2014 Interpretative Guidelines on Regulation (EC) No 1371/2007 of the European Parliament and of the Council on rail passengers' rights and obligations (OJ C 220, 4.7.2015, pp. 1-10) Report from the Commission to the European Parliament and the Council on Exemptions granted by Member States under Regulation (EC) 1371/2007 on rail passengers' rights and obligations (COM(2015) 117 final, 11.3.2015) last update 19.03.2020"}
{"article": "4.6.2008 EN Official Journal of the European Union L 145/227 REGULATION (EC) No 452/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2008 concerning the production and development of statistics on education and lifelong learning (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof, Having regard to the proposal from the Commission, After consultation of the European Economic and Social Committee, Acting in accordance with the procedure laid down in Article 251 of the Treaty (1), Whereas: (1) The Council Resolution of 5 December 1994 on the promotion of education and training statistics in the European Union (2) requested the Commission, in close cooperation with the Member States, to expedite the development of education and training statistics. (2) The European Council held in Brussels on 22 and 23 March 2005 agreed to relaunch the Lisbon Strategy. It concluded that Europe must renew the basis of its competitiveness, increase its growth potential and its productivity and strengthen social cohesion, placing the main emphasis on knowledge, innovation and the optimisation of human capital. In that respect, the employability, adaptability and mobility of citizens is vital for Europe. (3) To attain these objectives, European systems of education and training must adapt to the requirements of the knowledge society and the need for an enhanced level of education and better quality employment. Statistics on education, training and lifelong learning are of the highest importance as a basis for political decisions. (4) Lifelong learning is a key element in developing and promoting a skilled, trained and adaptable workforce. In the Presidency Conclusions of the Spring 2005 European Council it was stressed that \u2018human capital is Europe's most important asset\u2019. The Integrated Guidelines for Growth and Jobs including the guidelines for the employment policies of the Member States, endorsed by the Council in its Decision 2005/600/EC (3), aim to contribute better to the Lisbon strategy and to establish comprehensive lifelong learning strategies. (5) The adoption in February 2001 of the Council Report \u2018Objectives of the education and training systems\u2019 and the adoption in February 2002 of the work programme for 2001-2011 on the follow-up to this report constitute an important step in honouring the commitment to modernise and improve the quality of the education and training systems of the Member States. Indicators and reference levels of European average performance (\u2018benchmarks\u2019) are among the instruments of the open method of coordination which are important for the \u2018Education and Training 2010\u2019 work programme. The Ministers of Education took a decisive step in May 2003 by agreeing on five European benchmarks to be attained by 2010, while stressing they do not define national targets or prescribe decisions to be taken by national governments. (6) On 24 May 2005, the Council adopted Conclusions on \u2018New indicators in education and training\u2019 (4). In these Conclusions the Council invited the Commission to present to the Council strategies and proposals for the development of new indicators in nine particular areas of education and training and also stressed that the development of new indicators should fully respect the responsibility of Member States for the organisation of their education systems and should not impose undue administrative or financial burdens on the organisation and institutions concerned, or inevitably lead to an increased number of indicators used to monitor progress. (7) The Council also adopted, in November 2004, Conclusions on European cooperation in vocational education and training, and agreed that priority should be given at European level to \u2018the improvement of the scope, precision and reliability of vocational education and training statistics in order to enable evaluation of progress\u2019. (8) Comparable statistical information at Community level is essential for the development of education and lifelong learning strategies and for the monitoring of progress in their implementation. Statistical production should be based on a framework of coherent concepts and comparable data in view of the establishment of an integrated European statistical information system on education, training and lifelong learning. (9) When applying this Regulation, account should be taken of the notion of people at a disadvantage in the labour market referred to in the Guidelines for the employment policies of the Member States. (10) The Commission (Eurostat) is collecting data on vocational training in enterprises in accordance with Regulation (EC) No 1552/2005 of the European Parliament and of the Council of 7 September 2005 on the statistics relating to vocational training in enterprises (5). However, a broader legal framework is necessary to ensure the sustainable production and development of statistics on education and lifelong learning, covering at least all relevant existing and planned activities. The Commission (Eurostat) is collecting annual data on education from the Member States on a voluntary basis, through a joint action carried out with the Unesco Institute for Statistics (UIS) and with the Organisation for Economic Cooperation and Development (OECD), usually referred to as the \u2018UOE data collection\u2019. The Commission (Eurostat) is also collecting data on education, training and lifelong learning through other household sources such as the European Union Labour Force Survey (6) and the Community statistics on income and living conditions (7) as well as through their ad-hoc modules. (11) Since policy formulation and monitoring in the field of education and lifelong learning is of a dynamic nature and adapts to an evolving environment, the statistical regulatory framework should provide for a certain degree of flexibility in a limited and controlled manner, taking into account the burden for respondents and the Member States. (12) Since the objective of this Regulation, namely the creation of common statistical standards that permit the production of harmonised data cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (13) The production of specific Community statistics is governed by the rules set out in Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (8). (14) This Regulation ensures full respect for the right to the protection of personal data as provided for in Article 8 of the Charter of Fundamental Rights of the European Union. (15) The transmission of data subject to statistical confidentiality is governed by the rules set out in Regulation (EC) No 322/97 and in Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (9). (16) Commission Regulation (EC) No 831/2002 of 17 May 2002 implementing Council Regulation (EC) No 322/97 on Community statistics concerning access to confidential data for scientific purposes (10) established the conditions pursuant to which access to confidential data transmitted to the Community authority may be granted. (17) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (11). (18) In particular, the Commission should be empowered to select and specify the subjects of the statistics, their characteristics in response to policy or technical needs, the breakdown of characteristics, the observation period and deadlines for transmission of results, the quality requirements including the required precision and the quality reporting framework. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (19) The Statistical Programme Committee established by Council Decision 89/382/EEC, Euratom (12), has been consulted in accordance with Article 3 of that Decision, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes a common framework for the systematic production of Community statistics in the field of education and lifelong learning. Article 2 Definitions For the purpose of this Regulation: (a) \u2018Community statistics\u2019 shall be defined as in the first indent of Article 2 of Regulation (EC) No 322/97; (b) \u2018production of statistics\u2019 shall be defined as in the second indent of Article 2 of Regulation (EC) No 322/97; (c) \u2018national authorities\u2019 shall be defined as in the third indent of Article 2 of Regulation (EC) No 322/97; (d) \u2018education\u2019 means organised and sustained communication designed to bring about learning (13); (e) \u2018lifelong learning\u2019 means all learning activity undertaken throughout life, with the aim of improving knowledge, skills and competences within a personal, civic, social and/or employment-related perspective (14); (f) \u2018micro-data\u2019 means individual statistical records; (g) \u2018confidential data\u2019 means data which allow only indirect identification of the statistical units concerned, in accordance with Regulation (EC) No 322/97 and Regulation (Euratom, EEC) No 1588/90. Article 3 Domains This Regulation shall apply to the production of statistics in three domains: (a) Domain 1 shall cover statistics on education and training systems; (b) Domain 2 shall cover statistics on the participation of adults in lifelong learning; (c) Domain 3 shall cover other statistics on education and lifelong learning, such as statistics on human capital and on the social and economic benefits of education, not covered by Domains 1 and 2. The production of statistics in those domains shall be carried out in accordance with the Annex. Article 4 Statistical actions 1. The production of Community statistics in the field of education and lifelong learning shall be implemented by individual statistical actions as follows: (a) the regular delivery of statistics on education and lifelong learning by the Member States, within specified deadlines for Domains 1 and 2; (b) the use of other statistical information systems and surveys, to provide additional statistical variables and indicators on education and lifelong learning, corresponding to Domain 3; (c) the development, improvement and updating of standards and manuals on statistical frameworks, concepts and methods; (d) the improvement of data quality, in the context of the quality framework, to include: \u2014 relevance, \u2014 accuracy, \u2014 timeliness and punctuality, \u2014 accessibility and clarity, \u2014 comparability, and \u2014 coherence. Available capacities within the Member States for data collection and the processing and development of concepts and methods shall be taken into account by the Commission. Where appropriate, special attention and consideration shall be given to the regional dimension of the data collected. Where appropriate, data shall be systematically broken down by gender. 2. Whenever possible, the Commission (Eurostat) shall seek cooperation with the UIS, the OECD and other international organisations with a view to ensuring international comparability of data and to avoid duplication of effort, in particular as regards the development and improvement of statistical concepts and methods and the delivery of statistics by the Member States. 3. Whenever significant new data requirements or insufficient quality of data are identified and before any data collection, the Commission (Eurostat) shall institute pilot studies to be completed on a voluntary basis by the Member States. Such pilot studies shall be carried out in order to assess the feasibility of the relevant data collection, taking into consideration the benefits of the availability of the data in relation to the collection costs and the burden on respondents. Pilot studies shall not necessarily lead to corresponding implementing measures. Article 5 Transmission of micro-data on individuals When necessary for the production of Community statistics, Member States shall transmit confidential micro-data resulting from sample surveys to the Commission (Eurostat) in accordance with the provisions on the transmission of data subject to confidentiality set out in Regulation (EC) No 322/97 and in Regulation (Euratom, EEC) No 1588/90. Member States shall ensure that the transmitted data do not permit the direct identification of the statistical units (individuals). Article 6 Implementing measures 1. The following measures designed to amend non-essential elements of this Regulation by supplementing it, including measures to take account of economic and technical developments concerning the collection, transmission and processing of the data, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3) with a view to ensuring the transmission of high quality data: (a) the selection and specification of subjects covered by the domains and their characteristics in response to policy or technical needs; (b) the breakdowns of characteristics; (c) the observation period and deadlines for transmission of results; (d) the quality requirements, including the required precision; (e) the quality reporting framework. If these measures lead to a requirement for a significant enlargement of existing data collections or for new data collections or surveys, implementing decisions shall be based on a cost-benefit analysis as part of a comprehensive analysis of the effects and implications, taking into account the benefit of the measures, the costs for the Member States and the burden on respondents. 2. The measures referred to in paragraph 1 shall take account of the following: (a) for all Domains, the potential burden on educational institutions and individuals; (b) for all Domains, the results of the pilot studies referred to in Article 4(3); (c) for Domain 1, the latest agreements between the UIS, the OECD and the Commission (Eurostat) on concepts, definitions, data collection format, data processing, periodicity and deadlines for transmission of results; (d) for Domain 2, the results from the Adult Education Pilot Survey performed between 2005 and 2007 and further development needs; (e) for Domain 3, the availability, suitability and the legal context of existing Community data sources after an exhaustive examination of all existing data sources. 3. If necessary, limited derogations and transition periods for one or more Member States, both to be based upon objective grounds, shall be adopted in accordance with the regulatory procedure referred to in Article 7(2). Article 7 Committee 1. The Commission shall be assisted by the Statistical Programme Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 8 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 23 April 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J. LENAR\u010cI\u010c (1) Opinion of the European Parliament of 25 September 2007 (not yet published in the Official Journal) and Council Decision of 14 February 2008. (2) OJ C 374, 30.12.1994, p. 4. (3) OJ L 205, 6.8.2005, p. 21. (4) OJ C 141, 10.6.2005, p. 7. (5) OJ L 255, 30.9.2005, p. 1. (6) Commission Regulation (EC) No 2104/2002 of 28 November 2002 adapting Council Regulation (EC) No 577/98 on the organisation of a labour force sample survey in the Community and Commission Regulation (EC) No 1575/2000 implementing Council Regulation (EC) No 577/98 as far as the list of education and training variables and their codification to be used for data transmission from 2003 onwards are concerned (OJ L 324, 29.11.2002, p. 14). (7) Commission Regulation (EC) No 1983/2003 of 7 November 2003 implementing Regulation (EC) No 1177/2003 of the European Parliament and of the Council concerning Community statistics on income and living conditions (EU-SILC) as regards the list of target primary variables (OJ L 298, 17.11.2003, p. 34). (8) OJ L 52, 22.2.1997, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). (9) OJ L 151, 15.6.1990, p. 1. Regulation as amended by Regulation (EC) No 322/97. (10) OJ L 133, 18.5.2002, p. 7. Regulation as last amended by Regulation (EC) No 1000/2007 (OJ L 226, 30.8.2007, p. 7). (11) OJ L 184, 17.7.1999, p. 23, Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (12) OJ L 181, 28.6.1989, p. 47. (13) According to the 1997 version of the International Standard Classification of Education (ISCED). (14) Council Resolution of 27 June 2002 on lifelong learning (OJ C 163, 9.7.2002, p. 1). ANNEX DOMAINS Domain 1: Education and training systems 1. Aim The aim of this data collection is to provide comparable data on key aspects of education and training systems, specifically on the participation and completion of education programmes, as well as on the cost and type of resources dedicated to education and training. 2. Scope The data collection shall cover all domestic educational activities regardless of ownership of, or sponsorship by, the institutions concerned (whether public or private, national or foreign) and of the education delivery mechanism. Correspondingly, the coverage of the data collections shall extend to all student types and age groups. 3. Subjects covered Data shall be collected on: (a) students\u2019 enrolment, including the characteristics of the students; (b) entrants; (c) graduates and graduations; (d) education expenditure; (e) educational personnel; (f) foreign languages learnt; (g) class sizes; allowing the calculation of indicators on the inputs, processes and outputs of the education and training systems. Appropriate information (metadata) shall be transmitted by Member States, describing specificities of national education and training systems and their correspondence with international classifications as well as any deviations from the specifications of the data request and any other information which is essential for the interpretation of data and the compilation of comparable indicators. 4. Periodicity Data and metadata shall be supplied annually, if not otherwise specified, within the deadlines agreed between the Commission (Eurostat) and the national authorities taking into account the latest agreements between the UIS, the OECD and the Commission (Eurostat). Domain 2: Participation of adults in lifelong learning 1. Aim The aim of this survey shall be to provide comparable data on participation and non-participation of adults in lifelong learning. 2. Scope The statistical unit shall be the individual, covering at least the population age range of 25-64 years. In the case of the collection of information through a survey, proxy answers shall be avoided, wherever possible. 3. Subjects covered Subjects covered by the survey shall be: (a) participation and non-participation in learning activities; (b) characteristics of these learning activities; (c) information on self-reported skills; (d) socio-demographic information. Data on participation in social and cultural activities shall also be collected on a voluntary basis as explanatory variables useful for further analysis of the participants and non-participants\u2019 profiles. 4. Data sources and sample size The data source shall be a sample survey. Administrative data sources may be used to reduce the burden on respondents. Sample size shall be established on the basis of precision requirements that shall not require effective national sample sizes to be larger than 5 000 individuals, calculated on the assumption of simple random sampling. Within these limits, specific subpopulations shall require particular sampling considerations. 5. Periodicity Data shall be collected every five years. The first year of implementation shall be 2010, at the earliest. Domain 3: Other statistics on education and lifelong learning 1. Aim The aim of this data collection shall be to provide further comparable data on education and lifelong learning to support specific policies at the Community level not included in Domains 1 and 2. 2. Scope Other statistics on education and lifelong learning shall refer to the following aspects: (a) statistics on education and the economy, required at Community level for monitoring policies on education, research, competitiveness and growth; (b) statistics on education and the labour market, required at Community level for monitoring employment policies; (c) statistics on education and social inclusion, required at Community level for monitoring policies on poverty, social inclusion and migrant integration. For the aspects listed above, the necessary data shall be acquired from existing Community statistical sources.", "summary": "Statistics on education and lifelong learning Statistics on education and lifelong learning SUMMARY OF: Regulation (EC) No 452/2008 \u2014 production and development of statistics on education and lifelong learning Regulation (EU) 2019/1700 establishing a common framework for European statistics relating to persons and households and amending Regulation (EC) No 452/2008 WHAT IS THE AIM OF THE REGULATION? It establishes a common framework on statistical standards for the production of harmonised data in the area of education and lifelong learning. KEY POINTS The regulation covers the following domains: 1.education and training systems; 2.other statistics on education and lifelong learning (such as statistics on human capital and on the social and economic benefits of education). The production of statistics at European Union (EU) level is implemented by individual statistical actions including: for the first domain, regular and timely delivery of statistics by EU countries; within the scope of the second domain, the use of supplementary variables and indicators from other statistical information systems and surveys; developing, improving and updating standards and manuals that define frameworks, concepts and methods; improving data quality within the context of the quality framework. The European Commission will take into consideration the available capacities of EU countries with regard to the above actions. For the collected data, consideration will be given to regional and gender aspects whenever possible. The Commission (Eurostat) will also collaborate with the United Nations Educational, Scientific and Cultural Organisation\u2019s (UNESCO) Institute for Statistics, the Organisation for Economic Cooperation and Development (OECD) and other international organisations to ensure the comparability and avoid the duplication of data at international level. Education systems (UOE) From school year 2012/2013 onwards: Commission Regulation (EU) No 912/2013 of 23 September 2013 as regards statistics on education and training systems. Adult education survey (AES) 2016 AES: Commission Regulation (EU) No 1175/2014 of 30 October 2014 as regards statistics on the participation of adults in lifelong learning. FROM WHEN DOES THE REGULATION APPLY? Regulation (EC) No 452/2008 has applied since 24 June 2008. Amending Regulation (EU) 2019/1700 applies from 1 January 2021. BACKGROUND The production of comparable statistical data is essential for the development of education and lifelong learning strategies, and to monitor the implementation of these strategies. The strategic framework for European cooperation in education and training adopted in May 2009 sets a number of benchmarks to be achieved by 2020. Progress is assessed in the EU countries through the yearly country analysis, with the EU also providing recommendations. On the basis of the information provided, a 2015 joint report on EU cooperation in education and training identifies priority areas and concrete issues for future work at European level. The joint report was adopted in November 2015. For more information, see: Education and training (Eurostat). MAIN DOCUMENTS Regulation (EC) No 452/2008 of the European Parliament and of the Council of 23 April 2008 concerning the production and development of statistics on education and lifelong learning (OJ L 145, 4.6.2008, pp. 227-233) Regulation (EU) 2019/1700 of the European Parliament and of the Council of 10 October 2019 establishing a common framework for European statistics relating to persons and households, based on data at individual level collected from samples, amending Regulations (EC) No 808/2004, (EC) No 452/2008 and (EC) No 1338/2008 of the European Parliament and of the Council, and repealing Regulation (EC) No 1177/2003 of the European Parliament and of the Council and Council Regulation (EC) No 577/98 (OJ L 261I , 14.10.2019, pp. 1-32) RELATED DOCUMENTS 2015 Joint Report of the Council and the Commission on the implementation of the strategic framework for European cooperation in education and training (ET 2020) \u2014 New priorities for European cooperation in education and training (OJ C 417, 15.12.2015, pp. 25-35) Commission Regulation (EU) No 1175/2014 of 30 October 2014 implementing Regulation (EC) No 452/2008 of the European Parliament and of the Council concerning the production and development of statistics on education and lifelong learning, as regards statistics on the participation of adults in lifelong learning and repealing Commission Regulation (EU) No 823/2010 (OJ L 316, 4.11.2014, pp. 4-43) Commission Regulation (EU) No 912/2013 of 23 September 2013 implementing Regulation (EC) No 452/2008 of the European Parliament and of the Council concerning the production and development of statistics on education and lifelong learning, as regards statistics on education and training systems (OJ L 252, 24.9.2013, pp. 5-10) last update 09.01.2020"}
{"article": "14.11.2008 EN Official Journal of the European Union L 304/1 REGULATION (EC) No 1099/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 October 2008 on energy statistics (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof, Having regard to the proposal from the Commission, Acting in accordance with the procedure laid down in Article 251 of the Treaty (1), Whereas: (1) The Community needs to have precise and timely data on energy quantities, their forms, sources, generation, supply, transformation and consumption, for the purpose of monitoring the impact and consequences of its policy work on energy. (2) Energy statistics have traditionally been focused on energy supply and on fossil energies. In the coming years, greater focus is needed on increased knowledge and monitoring of final energy consumption, renewable energy and nuclear energy. (3) The availability of accurate, up-to-date information on energy is essential for assessing the impact of energy consumption on the environment, in particular in relation to the emission of greenhouse gasses. This information is required by Decision No 280/2004/EC of the European Parliament and of the Council of 11 February 2004 concerning a mechanism for monitoring Community greenhouse gas emissions and for implementing the Kyoto Protocol (2). (4) Directive 2001/77/EC of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market (3) and Directive 2004/8/EC of the European Parliament and of the Council of 11 February 2004 on the promotion of cogeneration based on a useful heat demand in the internal energy market (4) require Member States to report quantitative energy data. In order to monitor progress towards the achievement of the objectives set in those Directives, detailed, up-to-date energy data are required. (5) Directive 2002/91/EC of the European Parliament and of the Council of 16 December 2002 on the energy performance of buildings (5), Directive 2006/32/EC of the European Parliament and of the Council of 5 April 2006 on energy end-use efficiency and energy services (6) and Directive 2005/32/EC of the European Parliament and of the Council of 6 July 2005 establishing a framework for the setting of ecodesign requirements for energy-using products (7) require Member States to report quantitative energy consumption data. To monitor progress towards the achievement of the objectives set in those Directives, detailed, up-to-date energy data, as well as a better interface between these energy data and related statistical surveys such as the population and housing censuses and transportation data, are required. (6) The Green Papers of the Commission of 22 June 2005 on Energy Efficiency and of 8 March 2006 on a European Strategy for Sustainable, Competitive and Secure Energy discuss EU energy policies for which the availability of EU energy statistics are required, including for the purpose of establishing a European Energy Market Observatory. (7) The establishment of a public domain energy forecast model, as called for by the European Parliament in its Resolution of 14 December 2006 on a European Strategy for Sustainable, Competitive and Secure Energy (8) requires detailed, up-to-date energy data. (8) In the coming years, greater attention should be paid to the security of supply of the most important fuels and more timely and more accurate data at EU level is needed to anticipate and coordinate EU solutions to possible supply crises. (9) The liberalisation of the energy market and its growing complexity make it increasingly difficult to obtain reliable, timely energy data in the absence, in particular, of a legal basis concerning the provision of such data. (10) In order for the energy statistics system to assist political decision-making by the European Union and its Member States and promote public debate which includes citizens, it must afford guarantees of comparability, transparency, flexibility and ability to evolve. Thus, in the near future, statistics on nuclear energy should be incorporated and relevant data concerning renewable energy should be developed more. Similarly, with regard to energy efficiency, the availability of detailed statistics on habitat and transport would be extremely useful. (11) The production of Community statistics is governed by the rules set out in Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (9). (12) Since the objective of this Regulation, namely establishing a common framework for the production, transmission, evaluation and dissemination of comparable energy statistics in the Community cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (13) In the production and dissemination of Community statistics under this Regulation, the national and Community statistical authorities should take account of the principles set out in the European Statistics Code of Practice, which was adopted on 24 February 2005 by the Statistical Programme Committee, established by Council Decision 89/382/EEC, Euratom (10) and attached to the Recommendation of the Commission on the independence, integrity and accountability of the national and Community statistical authorities. (14) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (11). (15) In particular, power should be conferred on the Commission to modify the list of data sources, the national statistics and the applicable clarifications or definitions as well as the transmission arrangements and to establish and modify the annual nuclear statistics, once incorporated, to modify the renewable energy statistics, once incorporated, and to establish and modify the final energy consumption statistics. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5(a) of Decision 1999/468/EC. (16) It is necessary to provide that the Commission may grant exemptions or derogations to Member States from those aspects of the energy data collection that would lead to an excessive burden on respondents. The exemptions or derogations should be granted only upon receipt of a proper justification which indicates the present situation and the excessive burden transparently. The period for which they remain in force should be limited to the shortest time necessary. (17) The measures provided for in this Regulation are in accordance with the opinion of the Statistical Programme Committee, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. This Regulation establishes a common framework for the production, transmission, evaluation and dissemination of comparable energy statistics in the Community. 2. This Regulation shall apply to statistical data concerning energy products and their aggregates in the Community. Article 2 Definitions For the purpose of this Regulation, the following definitions shall apply: (a) \u2018Community statistics\u2019 mean Community statistics as defined in the first indent of Article 2 of Regulation (EC) No 322/97; (b) \u2018production of statistics\u2019 means production of statistics as defined in the second indent of Article 2 of Regulation (EC) No 322/97; (c) \u2018Commission (Eurostat)\u2019 means the Community authority as defined in the fourth indent of Article 2 of Regulation (EC) No 322/97; (d) \u2018energy products\u2019 mean combustible fuels, heat, renewable energy, electricity, or any other form of energy; (e) \u2018aggregates\u2019 mean data aggregated at national level on the treatment or use of energy products, namely production, trade, stocks, transformation, consumption, and structural characteristics of the energy system such as installed capacities for electricity generation or production capacities for oil products; (f) \u2018quality of data\u2019 means the following aspects of statistical quality: relevance, accuracy, timeliness and punctuality, accessibility and clarity, comparability, coherence and completeness. Article 3 Data sources 1. While applying the principles of maintaining a reduced burden on respondents and of administrative simplification, Member States shall compile data concerning energy products and their aggregates in the Community from the following sources: (a) specific statistical surveys addressed to the primary and transformed energy producers and traders, distributors and transporters, importers and exporters of energy products; (b) other statistical surveys addressed to final energy users in the sectors of manufacturing industry, transport, and other sectors, including households; (c) other statistical estimation procedures or other sources, including administrative sources, such as regulators of the electricity and gas markets. 2. Member States shall lay down the detailed rules concerning the reporting of the data needed for the national statistics as specified in Article 4 by undertakings and other sources. 3. The list of data sources may be modified in accordance with the regulatory procedure with scrutiny referred to in Article 11(2). Article 4 Aggregates, energy products and the transmission frequency of national statistics 1. The national statistics to be reported shall be as set out in the Annexes. They shall be transmitted with the following frequencies: (a) annual, for the energy statistics in Annex B; (b) monthly, for the energy statistics in Annex C; (c) short-term monthly, for the energy statistics in Annex D. 2. Applicable clarifications or definitions of the technical terms used are provided in the individual Annexes and also in Annex A (Clarifications of terminology). 3. The data to be forwarded and the applicable clarifications or definitions may be modified in accordance with the regulatory procedure with scrutiny referred to in Article 11(2). Article 5 Transmission and dissemination 1. Member States shall transmit to the Commission (Eurostat) the national statistics referred to in Article 4. 2. The arrangements for their transmission, including the applicable time limits, derogations and exemptions therefrom, shall be as set out in the Annexes. 3. The arrangements for the transmission of the national statistics may be modified in accordance with the regulatory procedure with scrutiny referred in Article 11(2). 4. At the duly justified request of a Member State, additional exemptions or derogations may be granted by the Commission in accordance with the regulatory procedure referred to in Article 11(3), for those parts of the national statistics for which the collection would lead to an excessive burden on respondents. 5. The Commission (Eurostat) shall disseminate yearly energy statistics by 31 January of the second year following the reported period. Article 6 Quality assessment and reports 1. Member States shall ensure the quality of the data transmitted. 2. Every reasonable effort shall be undertaken to ensure coherence between energy data declared in accordance with Annex B and data declared in accordance with Commission Decision 2005/166/EC of 10 February 2005 laying down the rules for implementing Decision No 280/2004/EC of the European Parliament and of the Council concerning a mechanism for monitoring Community greenhouse gas emissions and for implementing the Kyoto Protocol (12). 3. For the purposes of this Regulation, the following quality assessment dimensions shall apply to the data to be transmitted: (a) \u2018relevance\u2019 shall refer to the degree to which statistics meet current and potential needs of the users; (b) \u2018accuracy\u2019 shall refer to the closeness of estimates to the unknown true values; (c) \u2018timeliness\u2019 shall refer to the delay between the availability of the information and the event or phenomenon it describes; (d) \u2018punctuality\u2019 shall refer to the delay between the date of the release of the data and the target date when it should have been delivered; (e) \u2018accessibility\u2019 and \u2018clarity\u2019 shall refer to the conditions and modalities by which users can obtain, use and interpret data; (f) \u2018comparability\u2019 shall refer to the measurement of the impact of differences in applied statistical concepts and measurement tools and procedures where statistics are compared between geographical areas, sectoral domains or over time; (g) \u2018coherence\u2019 shall refer to the adequacy of the data to be reliably combined in different ways and for various uses. 4. Every five years, Member States shall provide the Commission (Eurostat) with a report on the quality of the data transmitted as well as on any methodological changes that have been made. 5. Within six months of receipt of a request from the Commission (Eurostat), and in order to allow it to assess the quality of the data transmitted, Member States shall send to the Commission (Eurostat) a report containing any relevant information concerning the implementation of this Regulation. Article 7 Time reference and frequency Member States shall compile all data specified in this Regulation from the beginning of the calendar year following the adoption of this Regulation, and shall transmit them from then onwards with the frequencies laid down in Article 4(1). Article 8 Annual nuclear statistics The Commission (Eurostat) shall, in cooperation with the nuclear energy sector in the EU, define a set of annual nuclear statistics which shall be reported and disseminated from 2009 onwards, that year being the first reported period, without prejudice to confidentiality, where it is necessary, and avoiding any duplication of data collection, while at the same time keeping production costs low and the reporting burden reasonable. The set of annual nuclear statistics shall be established and may be modified in accordance with the regulatory procedure with scrutiny referred to in Article 11(2). Article 9 Renewable energy statistics and final energy consumption statistics 1. With a view to improving the quality of renewable energy and final energy consumption statistics, the Commission (Eurostat), in collaboration with the Member States, shall make sure that these statistics are comparable, transparent, detailed and flexible by: (a) reviewing the methodology used to generate renewable energy statistics in order to make available additional, pertinent, detailed statistics on each renewable energy source, annually and in a cost-effective manner. The Commission (Eurostat) shall present and disseminate the statistics generated from 2010 (reference year) onwards; (b) reviewing and determining the methodology used at national and Community level to generate final energy consumption statistics (sources, variables, quality, costs) based on the current situation, existing studies and feasibility pilot studies, as well as cost-benefit analyses yet to be conducted, and evaluating the findings of the pilot studies and cost-benefit analyses with a view to establishing breakdown keys for final energies by sector and main energy uses and gradually integrating the resulting elements into the statistics from 2012 (reference year) onwards. 2. The set of renewable energy statistics may be modified in accordance with the regulatory procedure with scrutiny referred to in Article 11(2). 3. The set of final energy consumption statistics shall be established and may be modified in accordance with the regulatory procedure with scrutiny referred to in Article 11(2). Article 10 Implementing measures 1. The following measures necessary for implementation of this Regulation, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(2): (a) modifications to the list of data sources (Article 3(3)); (b) modifications to the national statistics and to the applicable clarifications or definitions (Article 4(3)); (c) modifications to the transmission arrangements (Article 5(3)); (d) establishment of and modifications to the annual nuclear statistics (Article 8(2)); (e) modifications to the renewable energy statistics (Article 9(2)); (f) establishment of and modifications to the final energy consumption statistics (Article 9(3)). 2. Additional exemptions or derogations (Article 5(4)) shall be granted in accordance with the regulatory procedure referred to in Article 11(3). 3. Consideration is to be given to the principle that additional costs and the reporting burden remain within reasonable limits. Article 11 Committee 1. The Commission shall be assisted by the Statistical Programme Committee. 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months. Article 12 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 22 October 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J.-P. JOUYET (1) Opinion of the European Parliament of 12 March 2008 (not yet published in the Official Journal) and Council Decision of 15 September 2008. (2) OJ L 49, 19.2.2004, p. 1. (3) OJ L 283, 27.10.2001, p. 33. (4) OJ L 52, 21.2.2004, p. 50. (5) OJ L 1, 4.1.2003, p. 65. (6) OJ L 114, 27.4.2006, p. 64. (7) OJ L 191, 22.7.2005, p. 29. (8) OJ C 317 E, 23.12.2006, p. 876. (9) OJ L 52, 22.2.1997, p. 1. (10) OJ L 181, 28.6.1989, p. 47. (11) OJ L 184, 17.7.1999, p. 23. (12) OJ L 55, 1.3.2005, p. 57. ANNEX A CLARIFICATIONS OF TERMINOLOGY This Annex supplies explanations or definitions of terms that are used in the other Annexes. 1. GEOGRAPHICAL NOTES For statistical reporting purposes only, the following geographical definitions apply: \u2014 Australia excludes the overseas territories, \u2014 Denmark excludes the Faeroe Islands and Greenland, \u2014 France includes Monaco and excludes the French overseas territories Guadeloupe, Martinique, French Guiana, R\u00e9union, Saint Pierre and Miquelon, New Caledonia, French Polynesia, Wallis and Futuna, Mayotte, \u2014 Italy includes San Marino and the Vatican, \u2014 Japan includes Okinawa, \u2014 The Netherlands excludes Suriname and the Netherlands Antilles, \u2014 Portugal includes the Azores and Madeira, \u2014 Spain includes the Canary Islands, the Balearic Islands, and Ceuta and Melilla, \u2014 Switzerland does not include Liechtenstein, \u2014 United States includes the 50 States, the District of Columbia, the US Virgin Islands, Puerto Rico and Guam. 2. AGGREGATES Producers are classified according to the purpose of production: \u2014 Main activity producer: enterprises, both privately or publicly owned, which generate electricity and/or heat for sale to third parties, as their principal activity. \u2014 Autoproducers: enterprises, both privately or publicly owned, which generate electricity and/or heat wholly or partly for their own use as an activity which supports their primary activity. Note: the Commission may further clarify terminology by adding relevant NACE references in accordance with the regulatory procedure with scrutiny referred to in Article 11(2) after a revision of the NACE classification has entered into force. 2.1. Supply and transformation sectors Production/indigenous production Quantities of fuels extracted or produced, calculated after any operation for removal of inert matter. Production includes the quantities consumed by the producer in the production process (e.g. for heating or operation of equipment and auxiliaries) as well as supplies to other producers of energy for transformation or other uses. Indigenous means: production from resources within the concerned state. Imports/exports For geographical definitions see \u2018Geographical notes\u2019 section. Unless specified differently, \u2018imports\u2019 refer to ultimate origin (the country in which the energy product was produced) for use in the country and \u2018exports\u2019 to the ultimate country of consumption of the produced energy product. Amounts are considered as imported or exported when they have crossed the political boundaries of the country, whether customs clearance has taken place or not. Where no origin or destination can be reported \u2018other\u2019 may be used. Statistical differences may arise if only total import and export are available on the above basis, while the geographical breakdown is based on a different survey, source or concept. In this case, differences shall be included under \u2018other\u2019. International marine bunkers Quantities of fuels delivered to ships of all flags that are engaged in international navigation. The international navigation may take place at sea, on inland lakes and waterways, and in coastal waters. Excluded is: \u2014 consumption by ships engaged in domestic navigation. The domestic/international split should be determined on the basis of port of departure and port of arrival, and not by the flag or nationality of the ship, \u2014 consumption by fishing vessels, \u2014 consumption by military forces. Stock changes The difference between the opening stock level and closing stock level for stocks held on national territory. Gross consumption (calculated) Calculated value, defined as: indigenous production + from other sources + imports - exports - international marine bunkers + stock changes Gross consumption (observed) The quantity actually recorded in surveys of end-use sectors. Statistical differences Calculated value, defined as: calculated gross consumption \u2014 observed gross consumption. Includes changes in stocks at final consumers when this cannot be specified as part of the \u2018stock changes\u2019. Reasons for any major differences should be stated. Main activity producer electricity plants Fuel quantities used to produce electricity. Fuels used by plants containing at least one CHP unit are to be reported under Main activity producer CHP plants. Main activity producer combined heat and power (CHP) plants Quantities of fuels used to produce electricity and heat. Main activity producer heat plants Quantities of fuels used to produce heat. Autoproducer electricity plants Quantities of fuels used to produce electricity. Fuels used by plants containing at least one CHP unit are to be reported under Autoproducer CHP plants. Autoproducer combined heat and power (CHP) plants Quantities of fuels that correspond to the quantity of electricity produced and heat sold. Autoproducer heat plants Quantities of fuels that correspond to the quantity of heat sold. Patent fuel plants Quantities used to produce fuels. Quantities used for heating and operation of equipment should not be declared here, but declared as consumption in the energy sector. Coke ovens Quantities used in coke ovens. Quantities used for heating and operation of equipment should not be declared here, but declared as consumption in the energy sector. BKB/PB plants Quantities of lignite or brown coal used to produce brown coal briquettes (BKB) or of peat to produce peat briquettes (PB). Quantities used for heating and operation of equipment should not be declared here, but declared as consumption in the energy sector. Gasworks Quantities used to produce gas in gasworks and coal gasification plants. Quantities used as a fuel for heating and operation of equipment should not be included here, but declared as consumption in the energy sector. Blast furnace Quantities of coking coal and/or bituminous coal (generally referred to as PCI) and coke oven coke transformed in blast furnaces. Quantities used as a fuel for heating and operation of blast furnaces (e.g. blast furnaces gas) should not be included here, but declared as consumption in the energy sector. Coal liquefaction Quantities of fuel used to produce synthetic oil. Petroleum refineries Quantities used to produce petroleum products. Quantities used as a fuel for heating and operation of equipment should not be declared here, but declared as consumption in the energy sector. Not elsewhere specified \u2014 transformation Quantities used for transformation activities not included elsewhere. If used, what is included under this heading should be explained in the report. 2.2. Energy sector and final consumption Total energy sector Quantities consumed by the energy industry to support the extraction (mining, oil and gas production) or plant operations of transformation activities. Excludes quantities of fuels transformed into another energy form (which should be reported under the transformation sector) or used in support of the operation of oil, gas and coal slurry pipelines (which should be reported in the transport sector). Includes the manufacture of chemical materials for atomic fission and fusion and the products of these processes. Electricity, CHP and heat plants Quantities consumed as energy at electricity plants, combined heat and power plants (CHP) and heat plants. Coal mines Quantities consumed as energy to support the extraction and preparation of coal within the coal mining industry. Coal burned in pithead power stations should be reported in the transformation sector. Patent fuel plants Quantities consumed as energy at patent fuel plants. Coke ovens Quantities consumed as energy at coking plants. BKB/PB plants Quantities used as energy in BKP/PB plants. Gasworks/gasification works Quantities consumed as energy at gasworks and coal gasification plants. Blast furnaces Quantities consumed as energy at blast furnaces. Coal liquefaction Quantities consumed as energy at coal liquefaction plants. Petroleum refineries Quantities consumed as energy at petroleum refineries. Oil and gas extraction Quantities consumed as fuel in the oil and gas extraction process and in natural gas processing plants. Excludes pipeline losses (to be reported as distribution losses) and energy quantities used to operate pipelines (to be reported in the transport sector). Total final consumption Defined (calculated) as: = total non-energy use + final energy consumption (industry + transport + other sectors) It excludes deliveries for transformation, use by the energy producing industries, and distribution losses. Non-energy use Energy products used as raw materials in the different sectors; that is, not consumed as a fuel or transformed into another fuel. 2.3. Energy end-use specification Final energy consumption Total energy consumption in industry, transport and other sectors. Industry sector This refers to fuel quantities consumed by the industrial undertaking in support of its primary activities. For heat-only or CHP plants, only quantities of fuels consumed for the production of heat used by the plant itself are applicable. Quantities of fuels consumed for the production of heat that is sold, and for the production of electricity, should be reported under the appropriate transformation sector. Iron and steel Chemical (including petrochemical) Chemical and petrochemical industries. Non-ferrous metals Non-ferrous metals industries. Non-metallic minerals Glass, ceramic, cement and other building materials industries. Transport equipment Industries related to the equipment used for transport. Machinery Fabricated metal products, machinery and equipment other than transport equipment. Mining and quarrying Excludes energy producing industries. Food, beverages and tobacco Pulp, paper and printing Includes production of recorded media. Wood and wood products (other than pulp and paper) Construction Textile and leather Not elsewhere specified \u2014 industry Consumption in sectors which is not covered above. Transport sector Energy used in all transport activities irrespective of the economic sector in which the activity occurs. Transport sector \u2014 rail All consumption for use in rail traffic, including industrial railways. Transport sector \u2014 domestic navigation Quantities delivered to vessels of all flags not engaged in international navigation (see International marine bunkers). The domestic/international split should be determined on the basis of port of departure and port of arrival and not by the flag or nationality of the ship. Transport sector \u2014 road Quantities used in road vehicles. Includes fuel used by agricultural vehicles on highways and lubricants for use in road vehicles. Excludes energy used in stationary engines (see other sectors), for non-highway use in tractors (see agriculture), military use in road vehicles (see other sectors \u2014 not elsewhere specified), bitumen used in road surfacing and energy used in engines at construction sites (see industry subsector construction). Transport sector \u2014 pipeline transport Quantities used as energy in the support and operation of pipelines transporting gases, liquids, slurries and other commodities. Includes energy used for pump stations and maintenance of the pipeline. Excludes energy used for the pipeline distribution of natural or manufactured gas, hot water or steam from the distributor to final users (to be reported in the energy sector), energy used for the final distribution of water to household, industrial, commercial and other users (to be included in commercial and public services) and losses occurring during this transport between distributor and final users (to be reported as distribution losses). Transport sector \u2014 international aviation Quantities of aviation fuels delivered to aircraft for international aviation. The domestic/international split should be determined on the basis of departure and landing locations and not by the nationality of the airline. Excludes fuels used by airlines for their road vehicles (to be reported in the transport sector \u2014 not elsewhere specified) and military use of aviation fuels (to be reported in the other sectors \u2014 not elsewhere specified). Transport sector \u2014 domestic aviation Quantities of aviation fuels delivered to aircraft for domestic aviation \u2014 commercial, private, agricultural, etc. Includes fuel used for purposes other than flying, e.g. bench testing of engines. The domestic/international split should be determined on the basis of departure and landing locations and not by the nationality of the airline. Excludes fuels used by airlines for their road vehicles (to be reported in the transport sector \u2014 not elsewhere specified) and military use of aviation fuels (to be reported in the other sector \u2014 not elsewhere specified). Transport sector \u2014 not elsewhere specified Quantities used for transport activities not included elsewhere. Includes fuels used by airlines for their road vehicles and fuels used in ports for ships' unloaders, various types of cranes. To be declared is what is included under this heading. Other sectors Sectors not specifically mentioned or not belonging to energy, industry or transport. Other sectors \u2014 commercial and public services Fuels consumed by business and offices in the public and private sectors. Other sectors \u2014 residential To be declared are fuels consumed by all households, including \u2018households with employed persons\u2019. Other sectors \u2014 agriculture/forestry Fuels consumed by users classified as agriculture, hunting and forestry. Other sectors \u2014 fishing Fuels delivered for inland, coastal and deep-sea fishing. Fishing should cover fuels delivered to ships of all flags that have refuelled in the country (include international fishing) and energy used in the fishing industry. Other sectors \u2014 not elsewhere specified These are activities not included elsewhere. This category includes military fuel use for all mobile and stationary consumption (e.g. ships, aircraft, road and energy used in living quarters), regardless of whether the fuel delivered is for the military of that country or for the military of another country. If used, what is included under this heading should be explained in the report. 3. OTHER TERMS The meaning of the following abbreviations applies: \u2014 TML: tetramethyl lead, \u2014 TEL: tetraethyl lead, \u2014 SBP: special boiling point, \u2014 LPG: liquified petroleum gas, \u2014 NGL: natural gas liquids, \u2014 LNG: liquefied natural gas, \u2014 CNG: compressed natural gas. ANNEX B ANNUAL ENERGY STATISTICS This Annex describes the scope, units, reported period, frequency, deadline and transmission modalities for the annual collection of energy statistics. Annex A applies for explanations of terms for which a specific explanation is not supplied in this Annex. 1. SOLID FOSSIL FUELS AND MANUFACTURED GASES 1.1. Applicable energy products Unless otherwise specified this data collection applies to all of the following energy products: Energy product Definition 1. Anthracite High rank coal used for industrial and residential applications. It has generally less than 10 % volatile matter and a high carbon content (about 90 % fixed carbon). Its gross calorific value is greater than 23 865 kJ/kg (5 700 kcal/kg) on an ash-free but moist basis. 2. Coking coal Bituminous coal with a quality that allows the production of a coke suitable to support a blast furnace charge. Its gross calorific value is greater than 23 865 kJ/kg (5 700 kcal/kg) on an ash-free but moist basis. 3. Other bituminous coal (steam coal) Coal used for steam raising purposes and includes all bituminous coal that is neither included under coking coal nor anthracite. It is characterised by higher volatile matter than anthracite (more than 10 %) and lower carbon content (less than 90 % fixed carbon). Its gross calorific value is greater than 23 865 kJ/kg (5 700 kcal/kg) on an ash-free but moist basis. If bituminous coal is used in coke ovens it should be reported as coking coal. 4. Sub-bituminous Coal Refers to non-agglomerating coal with a gross calorific value between 17 435 kJ/kg (4 165 kcal/kg) and 23 865 kJ/kg (5 700 kcal/kg) containing more than 31 % volatile matter on a dry mineral matter free basis. 5. Lignite/brown coal Non-agglomerating coal with a gross calorific value less than 17 435 kJ/kg (4 165 kcal/kg) and greater than 31 % volatile matter on a dry mineral matter free basis. Oil shale and tar sands produced and combusted directly should be reported in this category. Oil shale and tar sands used as inputs for other transformation processes should also be reported in this category. This includes the portion of the oil shale or tar sands consumed in the transformation process. Shale oil and other products derived from liquefaction should be reported on the Annual Oil Questionnaire. 6. Peat A combustible soft, porous or compressed, sedimentary deposit of plant origin with high water content (up to 90 % in the raw state), easily cut, of light to dark brown colour. Peat used for non-energy purposes is not included. This definition is without prejudice to the definition of renewable energy sources in Directive 2001/77/EC and to the 2006 IPCC Guidelines for National Greenhouse Gas Inventories. 7. Patent fuel A composition fuel manufactured from hard coal fines with the addition of a binding agent. The amount of patent fuel produced may, therefore, be slightly higher than the actual amount of coal consumed in the transformation process. 8. Coke oven coke The solid product obtained from carbonisation of coal, principally coking coal, at high temperature, it is low in moisture and volatile matter. Coke oven coke is used mainly in the iron and steel industry acting as energy source and chemical agent. Coke breeze and foundry coke are included in this category. Semi-coke (a solid product obtained from carbonisation of coal at low temperature) should be included in this category. Semi-coke is used as a domestic fuel or by the transformation plant itself. This heading also includes coke, coke breeze and semi-coke made from lignite/brown coal. 9. Gas coke By-product of hard coal used for production of town gas in gasworks. Gas coke is used for heating purposes. 10. Coal tar A result of the destructive distillation of bituminous coal. Coal tar is the liquid by-product of the distillation of coal to make coke in the coke oven process or it is produced from brown coal (low-temperature tar). Coal tar can be further distilled into different organic products (e.g. benzene, toluene, naphthalene), which normally would be reported as a feedstock to the petrochemical industry. 11. BKB (brown coal briquettes) BKB is a composition fuel manufactured from lignite/brown coal, produced by briquetting under high pressure without the addition of a binding agent. These figures include peat briquettes, dried lignite fines and dust. 12. Gasworks gas Covers all types of gases produced in public utility or private plants, whose main purpose is manufacture, transport and distribution of gas. It includes gas produced by carbonisation (including gas produced by coke ovens and transferred to gasworks gas), by total gasification with or without enrichment with oil products (LPG, residual fuel oil, etc.), and by reforming and simple mixing of gases and/or air, reported under the rows \u2018from other sources\u2019. Under the transformation sector identify amounts of gasworks gas transferred to blended natural gas which will be distributed and consumed through the natural gas grid. The production of other coal gases (i.e. coke oven gas, blast furnace gas and oxygen steel furnace gas) should be reported in the columns concerning such gases, and not as production of gasworks gas. The coal gases transferred to gasworks plants should then be reported (in their own column) in the transformation sector in the gasworks plants row. The total amount of gasworks gas resulting from transfers of other coal gases should appear in the production line for gasworks gas. 13. Coke oven gas Obtained as a by-product of the manufacture of coke oven coke for the production of iron and steel. 14. Blast furnace gas Produced during the combustion of coke in blast furnaces in the iron and steel industry. It is recovered and used as a fuel partly within the plant and partly in other steel industry processes or in power stations equipped to burn it. The quantity of fuel should be reported on a gross calorific value basis. 15. Oxygen steel furnace gas By-product of the production of steel in an oxygen furnace, recovered on leaving the furnace. The gas is also known as converter gas, LD gas or BOS gas. 16. Hard coal The term \u2018hard coal\u2019 refers to coal of gross calorific value greater than 23 865 kJ/kg (5 700 kcal/kg) on an ashfree but moist basis and with a mean random reflectance of vitrinite of at least 0,6. Hard coal comprises all energy products from 1 to 3 together (anthracite, coking coal and other bituminous coal). 1.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. Annex A applies for explanations of terms for which a specific explanation is not supplied in this Annex. 1.2.1. Supply and transformation sectors 1. Production 1.1. Of which: underground Applicable only for anthracite, coking coal, other bituminous coal, sub-bituminous coal and lignite/brown coal. 1.2. Of which: surface Applicable only for anthracite, coking coal, other bituminous coal, sub-bituminous coal and lignite/brown coal. 2. From other sources This consists of two components: \u2014 recovered slurries, middlings and other low-grade coal products, which cannot be classified according to type of coal. This includes coal recovered from waste piles and other waste receptacles, \u2014 supplies of fuel of which production is covered in other fuel energy balances, but for which consumption will occur in the coal energy balance. 2.1. Of which: from oil products Not applicable for anthracite, coking coal, other bituminous coal, sub-bituminous coal and lignite/brown coal and peat. E.g. petroleum coke addition to coking coal for coke ovens. 2.2. Of which: from natural gas Not applicable for anthracite, coking coal, other bituminous coal, sub-bituminous coal and lignite/brown coal and peat. E.g. natural gas addition to gasworks gas for direct final consumption. 2.3. Of which: from renewables Not applicable for anthracite, coking coal, other bituminous coal, sub-bituminous coal and lignite/brown coal and peat. E.g. industrial waste as binding agent in the manufacturing of patent fuel. 3. Imports 4. Exports 5. International marine bunkers 6. Stock changes A stock build is shown as a negative number and a stock draw is shown as a positive number. 7. Gross consumption 8. Statistical differences 9. Total transformation sector Quantities of fuels used for the primary or secondary conversion of energy (e.g. coal to electricity, coke oven gas to electricity) or used for the transformation to derived energy products (e.g. coking coal to coke). 9.1. Of which: main activity producer electricity plants 9.2. Of which: main activity producer CHP plants 9.3. Of which: main activity producer heat plants 9.4. Of which: autoproducer electricity plants 9.5. Of which: autoproducer CHP plants 9.6. Of which: autoproducer heat plants 9.7. Of which: patent fuel plants 9.8. Of which: coke ovens 9.9. Of which: BKB/PB plants 9.10. Of which: gasworks 9.11. Of which: blast furnaces Quantities of coking coal and/or bituminous coal (generally referred to as PCI) and coke oven coke transformed in blast furnaces. Amounts used as a fuel for heating and operation of blast furnaces (e.g. blast furnaces gas) should not be included in the transformation sector, but reported as consumption in the energy sector. 9.12. Of which: coal liquefaction Shale oil and other products derived from liquefaction should be reported as per Chapter 4 of this Annex. 9.13. Of which: for blended natural gas Quantities of coal gases blended with natural gas. 9.14. Of which: not elsewhere specified \u2014 transformation 1.2.2. Energy sector 1. Total energy sector 1.1. Of which: electricity, CHP and heat plants 1.2. Of which: coal mines 1.3. Of which: patent fuel plants 1.4. Of which: coke ovens 1.5. Of which: BKB/PB plants 1.6. Of which: gasworks 1.7. Of which: blast furnaces 1.8. Of which: petroleum refineries 1.9. Of which: coal liquefaction 1.10. Of which: not elsewhere specified \u2014 energy 2. Distribution losses Losses occurred due to transport and distribution, as well as flaring of manufactured gases. 3. Total final consumption 4. Total non-energy use 4.1. Of which: industry, transformation and energy sectors Non-energy use in all industry, transformation and energy subsectors, e.g. coal used to make methanol or ammonia. 4.1.1. From 4.1, of which: in the petrochemical sector Non-energy use e.g. coal use as feedstocks to produce fertiliser and as feedstocks for other petrochemical products. 4.2. Of which: transport sector Non-energy use in all transport subsectors. 4.3. Of which: other sectors Non-energy use in commercial and public services, residential, agriculture and Not elsewhere specified other. 1.2.3. Energy end-use specification 1. Final energy consumption 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector 3.1. Of which: rail 3.2. Of which: domestic navigation 3.3. Of which: not elsewhere specified \u2014 transport 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified \u2014 other 1.2.4. Imports and exports Imports by country of origin, and exports by country of destination. Not applicable to peat, gas coke, gasworks gas, coke oven gas, blast furnace gas nor oxygen steel furnace gas. 1.2.5. Inputs to autoproducers of electricity and heat generation Inputs to autoproducers of electricity and heat generation are to be declared separately for electricity-only plants, for CHP plants, and for heat-only plants. These inputs to autoproducers are separated for the main activities listed in the following table: 1. Total energy sector 1.1. Of which: coal mines 1.2. Of which: patent fuel plants 1.3. Of which: coke ovens 1.4. Of which: BKB/PB plants 1.5. Of which: gasworks 1.6. Of which: blast furnaces 1.7. Of which: petroleum refineries 1.8. Of which: coal liquefaction 1.9. Of which: not elsewhere specified \u2014 energy 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector 3.1. Of which: rail 3.2. Of which: not elsewhere specified \u2014 transport 4. Other sectors: 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified 1.3. Calorific values Both gross and net calorific values are to be declared for the energy products mentioned in paragraph 1.1 for the following main aggregates. Not applicable for gasworks gas, coke oven gas, blast furnace gas and oxygen steel furnace gas: 1. Production 2. Imports 3. Exports 4. Used in coke ovens 5. Used in blast furnaces 6. Used in main activity producer electricity, CHP and heat plants 7. Used in industry 8. For other uses 1.4. Production and stocks in coal mines Only applicable for hard coal and for lignite/brown coal. The following quantities must be declared: 1. Underground production 2. Surface production 3. From other sources 4. Stocks at end of period 4.1. Of which: stocks at mines 1.5. Units of measurement 1. Energy quantities 103 tonnes Exception: for gases (gasworks gas, coke oven gas, blast furnace gas, oxygen steel furnace gas) the measurement is directly in energy content and the unit to be used is therefore TJ (based on gross calorific values). 2. Calorific values MJ/tonne 1.6. Derogations and exemptions Not applicable. 2. NATURAL GAS 2.1. Applicable energy products This data collection applies to natural gas, which comprises gases occurring in underground deposits, whether liquefied or gaseous, consisting mainly of methane. It includes both \u2018non-associated\u2019 gas originating from fields producing hydrocarbons only in gaseous form, and \u2018associated\u2019 gas produced in association with crude oil as well as methane recovered from coal mines (colliery gas) or from coal seams (coal seam gas). It does not include gases created by anaerobic digestion of biomass (e.g. municipal or sewage gas) nor gasworks gas. 2.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. 2.2.1. Supply and transformation sectors To be declared are quantities expressed in both volume and energy units, and including the gross and net calorific values, for the following aggregates: 1. Indigenous production All dry marketable production within national boundaries, including offshore production. Production is measured after purification and extraction of NGLs and sulphur. Excludes extraction losses and quantities reinjected, vented or flared. Includes quantities used within the natural gas industry; in gas extraction, pipeline systems and processing plants. 1.1. Of which: associated gas Natural gas produced in association with crude oil. 1.2. Of which: non-associated gas Natural gas originating from fields producing hydrocarbons only in gaseous form. 1.3. Of which: colliery gas Methane produced at coal mines or from coal seams, piped to the surface and consumed at collieries or transmitted by pipeline to consumers. 2. From other sources Fuels which are blended with natural gas, and consumed as a blend. 2.1. Of which: from oil products LPG for upgrading the quality e.g. heat content. 2.2. Of which: from coal Manufactured gas for blending with natural gas. 2.3. Of which: from renewables Biogas for blending with natural gas. 3. Imports 4. Exports 5. International marine bunkers 6. Stock changes A stock build is shown as a negative number and a stock draw is shown as a positive number. 7. Gross consumption 8. Statistical differences The requirement of declaring calorific values is not applicable here. 9. Recoverable gas: opening and closing stocks Quantities of gas available for delivery during any input-output cycle. This refers to recoverable natural gas stored in special storage facilities (depleted gas and/or oil field, aquifer, salt cavity, mixed caverns, or other) as well as liquefied natural gas storage. Cushion gas should be excluded. The requirement of declaring calorific values is not applicable here. 10. Gas vented The volume of gas released into the air on the production site or at the gas processing plant. The requirement of declaring calorific values is not applicable here. 11. Gas flared The volume of gas burned in flares on the production site or at the gas processing plant. The requirement of declaring calorific values is not applicable here. 12. Total transformation sector Quantities of fuels used for the primary or secondary conversion of energy (e.g. natural gas to electricity) or used for the transformation to derived energy products (e.g. natural gas to methanol). 12.1. Of which: main activity producer electricity plants 12.2. Of which: autoproducer electricity plants 12.3. Of which: main activity producer CHP plants 12.4. Of which: autoproducer CHP plants 12.5. Of which: main activity producer heat plants 12.6. Of which: autoproducer heat plants 12.7. Of which: gasworks 12.8. Of which: coke ovens 12.9. Of which: blast furnaces 12.10. Of which: gas-to-liquids Quantities of natural gas used as feedstock for the conversion to liquids e.g. the quantities of fuel entering the methanol production process for transformation into methanol. 12.11. Of which: non-specified \u2014 transformation 2.2.2. Energy sector 1. Total energy sector 1.1. Of which: coal mines 1.2. Of which: oil and gas extraction 1.3. Of which: inputs to oil refineries 1.4. Of which: coke ovens 1.5. Of which: blast furnaces 1.6. Of which: gasworks 1.7. Of which: electricity, CHP and heat plants 1.8. Of which: liquefaction (LNG) or gasification 1.9. Of which: gas-to-liquids 1.10. Of which: not elsewhere specified \u2014 energy 2. Losses of distribution and transport 2.2.3. Energy end-use specification Consumption of natural gas needs to be reported for both energy use and (wherever applicable) non-energy use separately, for all of the following aggregates: 1. Total final consumption Final energy consumption and non-energy use to be declared separately under this heading. 2. Transport sector 2.1. Of which: transport by road Includes both CNG and biogas. 2.1.1. Of which: biogas fraction in transport by road 2.2. Of which: pipeline transport 2.3. Of which: not elsewhere specified \u2014 transport 3. Industry sector 3.1. Of which: iron and steel 3.2. Of which: chemical and petrochemical 3.3. Of which: non-ferrous metals 3.4. Of which: non-metallic minerals 3.5. Of which: transport equipment 3.6. Of which: machinery 3.7. Of which: mining and quarrying 3.8. Of which: food, beverages and tobacco 3.9. Of which: pulp, paper and printing 3.10. Of which: wood and wood products 3.11. Of which: construction 3.12. Of which: textile and leather 3.13. Of which: not elsewhere specified \u2014 industry 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified \u2014 other 2.2.4. Imports and exports To be declared are both the quantities of the total natural gas and of the LNG part of it, per country of origin for imports and per country of destination for exports. 2.2.5. Inputs to autoproducers of electricity and heat generation Inputs to autoproducers of electricity and heat generation are to be declared separately for autoproducer electricity plants, autoproducer CHP plants and autoproducer heat plants. Inputs apply to the following plants or activities: 1. Total energy sector 1.1. Of which: coal mines 1.2. Of which: oil and gas extraction 1.3. Of which: inputs to oil refineries 1.4. Of which: coke ovens 1.5. Of which: gasworks 1.6. Of which: blast furnaces 1.7. Of which: liquefaction (LNG) and regasification plants 1.8. Of which: gas-to-liquids 1.9. Of which: not elsewhere specified \u2014 energy 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector 3.1. Of which: pipeline transport 3.2. Of which: not elsewhere specified \u2014 transport 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified 2.2.6. Gas storage capacities 1. Name Name of the site of the storage facility. 2. Type Type of storage, such as depleted gas field, salt cavern, etc. 3. Working capacity Total gas storage capacity, minus the cushion gas. The cushion gas is the total volume of gas required as a permanent inventory to maintain adequate underground storage reservoir pressures and deliverability rates throughout the output cycle. 4. Peak output Maximum rate at which gas can be withdrawn from the concerned storage. 2.3. Units of measurement 1. Energy quantities Unless indicated differently, quantities of natural gas are declared by its energy content, i.e. in TJ, based on the gross calorific value. Where physical quantities are required, the unit is in 106 m3 assuming reference gas conditions (15 oC, 101,325 kPa). 2. Calorific values KJ/m3, assuming reference gas conditions (15 oC, 101,325 kPa). 3. Storage working capacity 106 m3, assuming reference gas conditions (15 oC, 101,325 kPa). 4. Peak output 106 m3/day, assuming reference gas conditions (15 oC, 101,325 kPa). 2.4. Derogations and exemptions Not applicable. 3. ELECTRICITY AND HEAT 3.1. Applicable energy products This chapter covers heat and electricity. 3.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. Annex A applies for explanations of terms for which a specific explanation is not supplied in this chapter. The definitions and units mentioned in Chapters 1, 2, 4 and 5 apply to energy products belonging to solid fuels and manufactured gases, natural gas, oil and petroleum products, and renewable energy and energy from waste. 3.2.1. Supply and transformation sectors The following specific definitions apply to aggregates for electricity and heat in this chapter: \u2014 Gross electricity production: the sum of the electrical energy production by all the generating sets concerned (including pumped storage) measured at the output terminals of the main generators. \u2014 Gross heat production: the total heat produced by the installation and includes the heat used by the installation's auxiliaries which use a hot fluid (space heating, liquid fuel heating etc.) and losses in the installation/network heat exchanges, as well as heat from chemical processes used as a primary energy form. \u2014 Net electricity production: the gross electricity production less the electrical energy absorbed by the generating auxiliaries and the losses in the main generator transformers. \u2014 Net heat production: the heat supplied to the distribution system as determined from measurements of the outgoing and return flows. The aggregates mentioned in the next table must be declared separately for main activity producer plants and for autoproducer plants. Within these two types of plants, both gross and net electricity and heat production must be declared for electricity only, for CHP and for heat-only plants separately wherever applicable, for the following aggregates: 1. Total production 1.1. Of which: nuclear 1.2. Of which: hydro 1.2.1. Of which: part of hydro produced from pumped storage 1.3. Of which: geothermal 1.4. Of which: solar 1.5. Of which: tide, wave, ocean 1.6. Of which: wind 1.7. Of which: combustible fuels Fuels capable of igniting or burning, i.e. reacting with oxygen to produce a significant rise in temperature and combusted directly for the production of electricity and/or heat. 1.8. Of which: heat pumps Heat output from heat pumps only where the heat is sold to third parties (i.e. in cases where production occurs in the transformation sector). 1.9. Of which: electric boilers Quantities of heat from electric boilers where the output is sold to third parties. 1.10. Of which: heat from chemical processes Heat originating from processes without input energy, such as a chemical reaction. Excludes waste heat originating from energy-driven processes, which should be reported as heat produced from the corresponding fuel. 1.11. Of which: other sources \u2014 electricity (please specify) The aggregates mentioned in the next table must be declared as totals, for electricity and heat separately, wherever applicable. For the three first aggregates in the next table, quantities should be calculated from and be compatible with the values declared according to the previous table. 1. Total gross production 2. Own use by plant 3. Total net production 4. Imports See also explanation under 5 \u2018Exports\u2019. 5. Exports Amounts of electricity are considered as imported or exported when they have crossed the political boundaries of the country, whether customs clearance has taken place or not. If electricity is transited through a country, the amount should be reported as both an import and an export. 6. Used for heat pumps 7. Used for electric powered steam boilers 8. Used for pumped storage 9. Used for electricity production 10. Energy supplied For electricity: the sum of the net electrical energy production supplied by all power stations within the country, reduced by the amount used simultaneously for heat pumps, electrically powered steam boilers, pumping and reduced or increased by exports to or imports from abroad. For heat: the sum of the net heat production for sale by all plants within a country, reduced by heat used for electricity production and reduced or increased by exports or imports from abroad. 11. Transmission and distribution losses All losses due to transport and distribution of electrical energy and heat. For electricity, includes losses in transformers which are not considered as integral parts of the power plants. 12. Total consumption (calculated) 13. Statistical difference 14. Total consumption (observed) The electricity produced, the heat sold and the fuel quantities used, including their corresponding total energy (based on their net calorific value except for natural gas which is based on gross calorific value) from the combustibles listed in the next table must be declared separately for main activity producer plants and for autoproducer plants. Within these two types of plants, this electricity and heat production must be declared for electricity (only) plants, for CHP and for heat (only) plants separately wherever applicable: 1. Solid fuels and manufactured gases: 1.1. Anthracite 1.2. Coking coal 1.3. Other bituminous coal 1.4. Sub-bituminous coal 1.5. Lignite/brown coal 1.6. Peat 1.7. Patent fuel 1.8. Coke oven coke 1.9. Gas coke 1.10. Coal tar 1.11. BKB (brown coal briquettes) 1.12. Gasworks gas 1.13. Coke oven gas 1.14. Blast furnace gas 1.15. Oxygen steel furnace gas 2. Oil and petroleum products: 2.1. Crude oil 2.2. NGL 2.3. Refinery gas 2.4. LPG 2.5. Naphtha 2.6. Kerosene type jet fuel 2.7. Other kerosene 2.8. Gas/diesel (distillate fuel oil) 2.9. Heavy fuel oil 2.10. Bitumen (including orimulsion) 2.11. Petroleum coke 2.12. Other oil products 3. Natural gas 4. Renewable energy and energy from waste 4.1. Industrial waste (non-renewable) 4.2. Municipal waste (renewable) 4.3. Municipal waste (non-renewable) 4.4. Wood, wood waste and other solid waste 4.5. Landfill gas 4.6. Sewage sludge gas 4.7. Other biogas 4.8. Liquid biofuels 3.2.2. Electricity and heat consumption in the energy sector 1. Total energy sector Excludes own use by plant, used for pumped storage, heat pumps and electric boilers. 1.1. Of which: coal mines 1.2. Of which: oil and gas extraction 1.3. Of which: patent fuel plants 1.4. Of which: coke ovens 1.5. Of which: BKB/PB plants 1.6. Of which: gasworks 1.7. Of which: blast furnaces 1.8. Of which: petroleum refineries 1.9. Of which: nuclear industry 1.10. Of which: coal liquefaction plants 1.11. Of which: liquefaction (LNG)/regasification plants 1.12. Of which: gasification plants (biogas) 1.13. Of which: gas-to-liquids 1.14. Of which: not elsewhere specified \u2014 energy 3.2.3. Energy end-use specification 1. Industry sector 1.1. Of which: iron and steel 1.2. Of which: chemical and petrochemical 1.3. Of which: non-ferrous metals 1.4. Of which: non-metallic minerals 1.5. Of which: transport equipment 1.6. Of which: machinery 1.7. Of which: mining and quarrying 1.8. Of which: food, beverages and tobacco 1.9. Of which: pulp, paper and printing 1.10. Of which: wood and wood products 1.11. Of which: construction 1.12. Of which: textile and leather 1.13. Of which: not elsewhere specified \u2014 industry 2. Transport sector 2.1. Of which: rail 2.2. Of which: pipeline transport 2.3. Of which: not elsewhere specified \u2014 transport 3. Residential sector 4. Commercial and public services 5. Agriculture/forestry 6. Fishing 7. Not elsewhere specified \u2014 other 3.2.4. Imports and exports Imports and exports of energy quantities of electricity and heat by country. 3.2.5. Net production of electricity generation and net heat production from autoproducers Net production of electricity and net generation of heat from autoproducers of electricity generation and heat production are to be declared, for CHP plants, for electricity (only) plants and for heat (only) plants separately, in the following plants or activities: 1. Total energy sector 1.1. Of which: coal mines 1.2. Of which: oil and gas extraction 1.3. Of which: patent fuel plants 1.4. Of which: coke ovens 1.5. Of which: BKB/PB plants 1.6. Of which: gasworks 1.7. Of which: blast furnaces 1.8. Of which: petroleum refineries 1.9. Of which: coal liquefaction plants 1.10. Of which: liquefaction (LNG)/regasification plants 1.11. Of which: gasification plants (biogas) 1.12. Of which: gas-to-liquids 1.13. Of which: charcoal production plants 1.14. Of which: not elsewhere specified \u2014 energy 2. All other sectors: identical to the aggregate list as per \u20183.2.3 Energy end-use specification\u2019. 3.2.6. Inputs to autoproducers of electricity and heat generation Inputs to autoproducers of electricity and heat generation are to be declared separately for autoproducer electricity plants, autoproducer CHP plants and autoproducer heat plants. 1. For solid fuels and manufactured gases used by autoproducers, quantities must be reported from the following energy products: anthracite, coking coal, other bituminous coal, sub-bituminous coal, lignite/brown coal, peat, patent fuel, coke oven coke, gas coke, coal tar, BKB/PB, gasworks gas, coke oven gas, blast furnace gas and oxygen steel furnace gas. Their input quantities must be reported for the plants in the following activities: 1. Total energy sector 1.1. Of which: coal mines 1.2. Of which: patent fuel plants 1.3. Of which: coke ovens 1.4. Of which: BKB/PB plants 1.5. Of which: gasworks 1.6. Of which: blast furnaces 1.7. Of which: petroleum refineries 1.8. Of which: coal liquefaction 1.9. Of which: not elsewhere specified \u2014 energy 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector: 3.1. Of which: rail 3.2. Of which: not elsewhere specified \u2014 transport 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified 2. For oil products used by autoproducers, quantities must be reported from the following energy products: crude oil, NGL, refinery gas, LPG, naphtha, kerosene type jet fuel, other kerosene, gas/diesel (distillate fuel oil), heavy fuel oil, bitumen (including orimulsion), petroleum coke and other oil products. Their input quantities must be reported for the plants in the following activities: 1. Total energy sector 1.1. Of which: coal mines 1.2. Of which: oil and gas extraction 1.3. Of which: coke ovens 1.4. Of which: blast furnaces 1.5. Of which: gasworks 1.6. Of which: not elsewhere specified \u2014 energy 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector: 3.1. Of which: pipeline transport 3.2. Of which: not elsewhere specified \u2014 transport 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified 3. For natural gas used by autoproducers, quantities must be reported for the plants in the following activities: 1. Total energy sector 1.1. Of which: coal mines 1.2. Of which: oil and gas extraction 1.3. Of which: inputs to oil refineries 1.4. Of which: coke ovens 1.5. Of which: gasworks 1.6. Of which: blast furnaces 1.7. Of which: liquefaction (LNG) and regasification plants 1.8. Of which: gas-to-liquids 1.9. Of which: not elsewhere specified \u2014 energy 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector: 3.1. Of which: pipeline transport 3.2. Of which: not elsewhere specified \u2014 transport 4. Other sectors: 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified 4. For renewable energy and energy from waste used by autoproducers, quantities must be reported from the following energy products: geothermal energy, solar thermal, industrial waste (non-renewable), municipal waste (renewable), municipal waste (non-renewable), wood/wood waste/other solid waste, landfill gas, sewage sludge gas, other biogas and liquid biofuels. Their input quantities must be reported for the plants in the following activities: 1. Total energy sector 1.1. Of which: gasification plants 1.2. Of which: coal mines 1.3. Of which: patent fuel plants 1.4. Of which: coke ovens 1.5. Of which: petroleum refineries 1.6. Of which: BKB/PB plants 1.7. Of which: gasworks 1.8. Of which: blast furnaces 1.9. Of which: charcoal production plants 1.10. Of which: not elsewhere specified \u2014 energy 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector: 3.1. Of which: rail 3.2. Of which: not elsewhere specified \u2014 transport 4. Other sectors: 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified 3.3. Structural data on electricity and heat generation 3.3.1. Net maximum electrical capacity and peak load The capacity should be reported at 31 December of the relevant reported year. Includes electrical capacity of both electricity (only) and CHP plants. The net maximum electrical capacity is the sum of the net maximum capacities of all stations taken individually throughout a given period of operation. The period of operation assumed for present purposes is continuous running: in practice 15 hours or more per day. The net maximum capacity is the maximum power assumed to be solely active power that can be supplied, continuously, with all plant running, at the point of outlet to the network. The peak load is defined as the highest value of the power absorbed or supplied by a network or combination of networks within the country. The following quantities must be declared only for the network: 1. Total 2. Nuclear 3. Hydro 3.1. Of which: pumped storage 4. Geothermal 5. Solar 6. Tide, wave, ocean 7. Wind 8. Combustible fuels 8.1. Of which: steam 8.2. Of which: internal combustion 8.3. Of which: gas turbine 8.4. Of which: combined cycle 8.5. Of which: other To be specified if declared. 9. Peak load 10. Available capacity at time of peak 11. Date and time of peak load occurrence 3.3.2. Net maximum electrical capacity of combustible fuels Net maximum electrical capacity of combustible fuels must be declared for both main activity producers and autoproducers, and separately for each type of single-fired or multi-fired plant mentioned in the next table. Indications on which type of fuel is used as primary and alternate fuels must be added for all cases of multi-fired plants. 1. Single fuel fired: 1.1. Fired with coal or coal products Includes coke oven gas, blast furnace and oxygen steel furnace gas capacity. 1.2. Fired with liquid fuels Includes refinery gas capacity. 1.3. Fired with natural gas Includes gasworks gas capacity. 1.4. Fired with peat 1.5. Fired with combustible renewables and wastes 2. Multi-fired, solids and liquids 3. Multi-fired, solids and natural gas 4. Multi-fired, liquids and natural gas 5. Multi-fired, solids, liquids and natural gas Multi-fired systems include only units which can burn more than one fuel type on a continuous basis. Stations which have separate units using different fuels should be divided into the appropriate single-fuel categories. 3.4. Units of measurement 1. Energy quantities Electricity: GWh Heat: TJ Solid fuels and manufactured gases: the units of measurement in Chapter 1 of this Annex apply. Natural gas: the units of measurement in Chapter 2 of this Annex apply. Oil and petroleum products: the units of measurement in Chapter 4 of this Annex apply. Renewables and waste: the units of measurement in Chapter 5 of this Annex apply. 2. Capacity Electrical generation capacity: MWe Heat generation capacity: MWt 3.5. Derogations and exemptions France has a derogation for reporting the aggregates relating to heat. That derogation shall lapse as soon as France is able to forward this report and, at all events, no more than four years after the date of entry into force of this Regulation. 4. OIL AND PETROLEUM PRODUCTS 4.1. Applicable energy products Unless otherwise specified this data collection applies to all of the following energy products: Energy product Definition 1. Crude oil Crude oil is a mineral oil of natural origin comprising a mixture of hydrocarbons and associated impurities, such as sulphur. It exists in the liquid phase under normal surface temperature and pressure and its physical characteristics (density, viscosity, etc.) are highly variable. This category includes field or lease condensate recovered from associated and non-associated gas where it is commingled with the commercial crude oil stream. 2. NGL NGL are liquid or liquefied hydrocarbons recovered from natural gas in separation facilities or gas processing plants. Natural gas liquids include ethane, propane, butane (normal and iso-), (iso) pentane and pentanes plus (sometimes referred to as natural gasoline or plant condensate). 3. Refinery feedstocks A refinery feedstock is a processed oil destined for further processing (e.g. straight run fuel oil or vacuum gas oil) excluding blending. With further processing, it will be transformed into one or more components and/or finished products. This definition also covers returns from the petrochemical industry to the refining industry (e.g. pyrolysis gasoline, C4 fractions, gasoil and fuel oil fractions). 4. Additives/oxygenates Additives are non-hydrocarbon compounds added to or blended with a product to modify fuel properties (octane, cetane, cold properties, etc.): \u2014 oxygenates, such as alcohols (methanol, ethanol), ethers (such as MTBE (methyl tertiary butyl ether), ETBE (ethyl tertiary butyl ether), TAME (tertiary amyl methyl ether)), \u2014 esters (e.g. rapeseed or dimethylester, etc.), \u2014 chemical compounds (such as TML, TEL and detergents). Note: quantities of additives/oxygenates (alcohols, ethers, esters and other chemical compounds) reported in this category should relate to the quantities destined for blending with fuels or for fuel use. 4.1. Of which: biofuels Biogasoline and bio-diesels. The definitions of Chapter 5, Renewable energy and energy from waste, apply. Quantities of liquid biofuels reported in this category relate to the biofuel and not to the total volume of liquids into which the biofuels are blended. Excludes all trade of biofuels which have not been blended with transport fuels (i.e. in their pure form); these should be reported as per Chapter 5. The biofuels traded as part of transport fuels should be reported in the appropriate product indicating the biofuel portion. 5. Other hydrocarbons Synthetic crude oil from tar sands, shale oil, etc., liquids from coal liquefaction (see Chapter 1), output of liquids from natural gas conversion into gasoline (see Chapter 2), hydrogen and emulsified oils (e.g. orimulsion). Excludes oil shale production, for which Chapter 1 applies. The production of shale oil (secondary product) is to be reported as \u2018from other sources\u2019 in the \u2018other hydrocarbons category\u2019. 6. Refinery gas (not liquefied) Refinery gas includes a mixture of non-condensible gases mainly consisting of hydrogen, methane, ethane and olefins obtained during distillation of crude oil or treatment of oil products (e.g. cracking) in refineries. This also includes gases which are returned from the petrochemical industry. 7. Ethane A naturally gaseous straight-chain hydrocarbon (C2H6) extracted from natural gas and refinery gas streams. 8. LPG LPG are light paraffinic hydrocarbons derived from the refinery processes, crude oil stabilisation and natural gas processing plants. They consist mainly of propane (C3H8) and butane (C4Hl0) or a combination of the two. They could also include propylene, butylene, isopropylene and isobutylene. LPG are normally liquefied under pressure for transportation and storage. 9. Naphtha Naphtha is a feedstock destined for either the petrochemical industry (e.g. ethylene manufacture or aromatics production) or for gasoline production by reforming or isomerisation within the refinery. Naphtha comprises material in the 30 oC and 210 oC distillation range or part of this range. 10. Motor gasoline Motor gasoline consists of a mixture of light hydrocarbons distilling between 35 oC and 215 oC. It is used as a fuel for land based spark ignition engines. Motor gasoline may include additives, oxygenates and octane enhancers, including lead compounds such as TEL and TML. Includes motor gasoline blending components (excluding additives/oxygenates), e.g. alkylates, isomerate, reformate, cracked gasoline destined for use as finished motor gasoline. 10.1. Of which: biogasoline The definitions of Chapter 5, Renewable energy and energy from waste, apply. 11. Aviation gasoline Motor spirit prepared especially for aviation piston engines, with an octane number suited to the engine, a freezing point of - 60 oC and a distillation range usually within the limits of 30 oC and 180 oC. 12. Gasoline type jet fuel (naphtha type jet fuel or JP4) This includes all light hydrocarbon oils for use in aviation turbine power units, distilling between 100 oC and 250 oC. They are obtained by blending kerosenes and gasoline or naphthas in such a way that the aromatic content does not exceed 25 % in volume, and the vapour pressure is between 13,7 kPa and 20,6 kPa. 13. Kerosene type jet fuel Distillate used for aviation turbine power units. It has the same distillation characteristics between 150 oC and 300 oC (generally not above 250 oC) and flash point as kerosene. In addition, it has particular specifications (such as freezing point) which are established by the International Air Transport Association (IATA). Includes kerosene blending components. 14. Other kerosene Refined petroleum distillate used in sectors other than aircraft transport. It distils between 150 oC and 300 oC. 15. Gas/diesel oil (distillate fuel oil) Gas/diesel oil is primarily a medium distillate distilling between 180 oC and 380 oC. Includes blending components. Several grades are available depending on uses. 15.1. Of which: transport diesel On-road diesel oil for diesel compression ignition (cars, trucks, etc.), usually of low sulphur content. 15.1.1. From 15.1, of which: bio-diesels The definitions of Chapter 5, Renewable energy and energy from waste, apply. 15.2 Of which: heating and other gasoil Light heating oil for industrial and commercial uses, marine diesel and diesel used in rail traffic, other gas oil, including heavy gas oils which distil between 380 oC and 540 oC and which are used as petrochemical feedstocks. 16. Fuel oil All residual (heavy) fuel oils (including those obtained by blending). Kinematic viscosity is above 10 cSt at 80 oC. The flash point is always above 50 oC and density is always more than 0,90 kg/l. 16.1. Of which: low sulphur content Heavy fuel oil with sulphur content lower than 1 %. 16.2. Of which: high sulphur content Heavy fuel oil with sulphur content of 1 % or higher. 17. White spirit and SBP Refined distillate intermediates with a distillation in the naphtha/kerosene range. They are subdivided as: \u2014 Industrial spirit (SBP): light oils distilling between 30 oC and 200 oC. There are 7 or 8 grades of industrial spirit, depending on the position of the cut in the distillation range. The grades are defined according to the temperature difference between the 5 % volume and 90 % volume distillation points (which is not more than 60 oC). \u2014 White spirit: industrial spirit with a flash point above 30 oC. The distillation range of white spirit is 135 oC to 200 oC. 18. Lubricants Hydrocarbons produced from distillate by-product; they are mainly used to reduce friction between bearing surfaces. Includes all finished grades of lubricating oil, from spindle oil to cylinder oil, and those used in greases, motor oils and all grades of lubricating oil base stocks. 19. Bitumen Solid, semi-solid or viscous hydrocarbon with a colloidal structure, being brown to black in colour, obtained as a residue in the distillation of crude oil, by vacuum distillation of oil residues from atmospheric distillation. Bitumen is often referred to as asphalt and is primarily used for construction of roads and for roofing material. Includes fluidised and cut back bitumen. 20. Paraffin waxes These are saturated aliphatic hydrocarbons. These waxes are residues extracted when dewaxing lubricant oils. They have a crystalline structure which is more-or-less fine according to the grade. Their main characteristics are as follows: they are colourless, odourless and translucent, with a melting point above 45 oC. 21. Petroleum coke Black solid by-product, obtained mainly by cracking and carbonising petroleum derived feedstock, vacuum bottoms, tar and pitches in processes such as delayed coking or fluid coking. It consists mainly of carbon (90 to 95 %) and has a low ash content. It is used as a feedstock in coke ovens for the steel industry, for heating purposes, for electrode manufacture and for production of chemicals. The two most important qualities are \u2018green coke\u2019 and \u2018calcinated coke\u2019. Includes \u2018catalyst coke\u2019 deposited on the catalyst during refining processes; this coke is not recoverable and is usually burned as refinery fuel. 22. Other products All products not specifically mentioned above, for example: tar and sulphur. Includes aromatics (e.g. BTX or benzene, toluene and xylene) and olefins (e.g. propylene) produced within refineries. 4.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. 4.2.1. Supply and transformation sectors The following table applies to crude oil, NGL, refinery feedstocks, additives, biofuels and other hydrocarbons only: 1. Indigenous production Not applicable for refinery feedstocks and for biofuels. 2. From other sources additives, biofuels and other hydrocarbons, the production of which has already been covered in other fuel balances. Not applicable for crude oil, NGL and refinery feedstocks. 2.1. Of which: from coal Includes liquids produced from coal liquefaction plants, liquid output from coke ovens. 2.2. Of which: from natural gas The manufacture of synthetic gasoline may require natural gas as feedstock. The amount of gas for methanol manufacture is declared according to Chapter 2, while the receipts of methanol are declared here. 2.3. Of which: from renewables Includes biofuels which are for blending with transport fuels. Production is declared as per Chapter 5, while amounts for blending are declared here. 3. Backflows from petrochemical sector Finished or semi-finished products which are returned from final consumers to refineries for processing, blending or sale. They are usually by-products of petrochemical manufacturing. Only applicable for refinery feedstocks. 4. Products transferred Imported petroleum products which are reclassified as feedstocks for further processing in the refinery, without delivery to final consumers. Only applicable for refinery feedstocks. 5. Imports and exports Includes quantities of crude oil and products imported or exported under processing agreements (i.e. refining on account). Crude oil and NGLs should be reported as coming from the country of ultimate origin; refinery feedstocks and finished products should be reported as coming from the country of last consignment. Includes any gas liquids (e.g. LPG) extracted during the regasification of imported liquefied natural gas and petroleum products imported or exported directly by the petrochemical industry. Note: all trade of biofuels which have not been blended with transport fuels (i.e. in their pure form) should be reported in the Renewables Questionnaire. Re-exports of oil imported for processing within bonded areas should be included as an export of product from the processing country to the final destination. 6. Direct use Crude oil, NGL, additives and oxygenates (and the part which are biofuels), and other hydrocarbons used directly without being processed in petroleum refineries. Includes crude oil burned for electricity generation. 7. Stock changes A stock build is shown as a negative number and a stock draw is shown as a positive number. 8. Calculated refinery intake Total amount of product calculated to have entered the refinery process. It is defined as: indigenous production + from other sources + backflows from industry + products transferred + imports - exports - direct use + stock changes 9. Statistical differences Defined as the calculated refinery intake minus the observed one. 10. Observed refinery intake Amounts measured as input to refineries 11. Refinery losses The difference between refinery intake (observed) and gross refinery output. Losses may occur during the distillation processes due to evaporation. Reported losses are positive. There may be volumetric gains but no gains in mass. 12. Opening and closing total stocks on national territory All stocks on national territory, including stocks held by governments, by major consumers or by stockholding organisations, stocks held on board incoming ocean vessels, stocks held in bonded areas and stocks held for others, whether under bilateral government agreement or not. Opening and closing refers to the first and to the last day of the reporting period respectively. 13. Net calorific value Production, imports and exports, and overall average. The following table applies only to finished products (refinery gas, ethane, LPG, naphtha, motor gasoline, aviation gasoline, gasoline type jet fuel, kerosene type jet fuel, other kerosene, gas/diesel oil, low and high sulphur fuel oil, white spirit and SBP, lubricants, bitumen, paraffin waxes, petroleum coke and other products). Crude oil and NGL used for direct burn should be included in deliveries of finished products and interproduct transfers: 1. Primary product receipts Includes quantities of indigenous or imported crude oil (including condensate) and indigenous NGL used directly without being processed in a petroleum refinery and quantities of backflows from the petrochemical industry which, although not primary fuel, are used directly. 2. Gross refinery output Production of finished products at a refinery or blending plant. Excludes refinery losses, but includes refinery fuel. 3. Recycled products Finished products which pass a second time through the marketing network, after having been once delivered to final consumers (e.g. used lubricants which are reprocessed). These quantities should be distinguished from petrochemical backflows. 4. Refinery fuel Petroleum products consumed in support of the operation of a refinery. Excludes products used by oil companies outside the refining process, e.g. bunkers or oil tankers. Includes fuels used for the production at the refineries of electricity and heat sold. 4.1. Of which: used for electricity generation Amounts used to generate electricity in plants at refineries. 4.2. Of which: used for CHP production Amounts used in CHP plants at refineries. 5. Imports and exports 6. International marine bunkers 7. Interproduct transfers Quantities reclassified either because their specification has changed or because they are blended into another product. A negative entry for one product is compensated by a positive entry (or several entries) for one or several products and vice versa; the total net effect should be zero. 8. Products transferred Imported petroleum products which are reclassified as feedstocks for further processing in the refinery, without delivery to final consumers. 9. Stock changes A stock build is shown as a negative number and a stock draw is shown as a positive number. 10. Calculated gross inland deliveries This is defined as: primary product receipts + gross refinery output + recycled products - refinery fuel + imports - exports - international marine bunkers + interproduct transfers - products transferred + stock changes 11. Statistical difference Defined as the calculated gross inland delivery minus the observed one. 12. Observed gross inland deliveries The observed delivery of finished petroleum products from primary sources (e.g. refineries, blending plants, etc.) to the inland market. This figure may differ from the calculated figure due, for example, to differences in coverage and/or differences of definition in different reporting systems. 12.1. Of which: gross deliveries to the petrochemical sector Quantities of fuels delivered to the petrochemical sector. 12.2. Of which: energy use in the petrochemical sector Quantities of oil used as fuel for petrochemical processes such as steam cracking. 12.3. Of which: non-energy use in the petrochemical sector Quantities of oil used in the petrochemical sector for the purpose of producing ethylene, propylene, butylene, synthesis gas, aromatics, butadiene and other hydrocarbon-based raw materials in processes such as steam cracking, aromatics plants and steam reforming. Excludes amounts of oil used for fuel purposes. 13. Backflows from petrochemical sector to refineries 14. Opening and closing stock levels All stocks on national territory, including stocks held by governments, by major consumers or by stockholding organisations, stocks held on board incoming ocean vessels, stocks held in bonded areas and stocks held for others, whether under bilateral government agreement or not. Opening and closing refers to the first and to the last day of the reporting period respectively. 15. Stock changes at public utilities Changes in stocks which are held by public utilities and not included in the stock levels and stock changes reported elsewhere. A stock build is shown as a negative number and a stock draw is shown as a positive number. Includes crude oil and NGL used for direct burn, if applicable. 16. Net calorific value of gross inland deliveries For the transformation sector the following aggregates apply for all fuels, except for refinery feedstocks, additives/oxygenates, biofuels and other hydrocarbons, but including fuels used for non-energy purposes (petroleum cokes and others, to be declared separately): 1. Total transformation sector Total quantities of fuels used for the primary or secondary conversion of energy. 1.1. Of which: main activity producer electricity plants 1.2. Of which: autoproducer electricity plants 1.3. Of which: main activity producer CHP plants 1.4. Of which: autoproducer CHP plants 1.5. Of which: main activity producer heat plants 1.6. Of which: autoproducer heat plants 1.7. Of which: gasworks/gasification plants 1.8. Of which: blended natural gas 1.9. Of which: coke ovens 1.10. Of which: blast furnaces 1.11. Of which: petrochemical industry 1.12. Of which: patent fuel plants 1.13. Of which: not elsewhere specified \u2014 transformation 4.2.2. Energy sector For the energy sector the following aggregates apply for all fuels, except for refinery feedstocks, additives/oxygenates, biofuels and other hydrocarbons, but including fuels used for non-energy purposes (petroleum cokes and others, to be declared separately): 1. Total energy sector Total quantity used as energy in the energy sector. 1.1. Of which: coal mines 1.2. Of which: oil and gas extraction 1.3. Of which: coke ovens 1.4. Of which: blast furnaces 1.5. Of which: gasworks 1.6. Of which: power plants Electricity, CHP and heat plants. 1.7. Of which: not elsewhere specified \u2014 energy 2. Distribution losses Losses occurred outside the refinery due to transport and distribution. Includes pipeline losses. 4.2.3. Energy end-use specification For the energy end-use specification the following aggregates apply for all fuels, except for refinery feedstocks, additives/oxygenates, biofuels and other hydrocarbons, but including fuels used for non-energy purposes (petroleum cokes and others, to be declared separately): 1. Final energy consumption 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector 3.1. Of which: international aviation 3.2. Of which: domestic aviation 3.3. Of which: road 3.4. Of which: rail 3.5. Of which: domestic navigation 3.6. Of which: pipeline transport 3.7. Of which: not elsewhere specified \u2014 transport 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified \u2014 other 5. Total non-energy use Quantities used as raw materials in the different sectors and not consumed as a fuel or transformed into another fuel. These quantities are included into the aggregates listed above. 5.1. Of which: transformation sector 5.2 Of which: energy sector 5.3 Of which: transport sector 5.4 Of which: industry sector 5.4.1 Industry sector of which: chemical (inc. petrochemical) 5.5 Of which: other sectors 4.2.4. Imports and exports Imports by country of origin, and exports by country of destination. See also notes under point 4.2.1, aggregate 5. 4.2.5. Inputs to autoproducers of electricity and heat generation Inputs to autoproducers of electricity and heat generation are to be declared separately for electricity-only plants, for CHP plants, and for heat-only plants. Excludes the following energy products: refinery feedstocks, additives/oxygenates, biofuels, other hydrocarbons, ethane, motor gasoline, biogasoline, aviation gasoline, gasoline type jet fuel (naphtha type jet fuel or JP4), white spirit and SBP, and lubricants. Inputs apply to the following plants or activities: 1. Total energy sector Total quantity used as energy in the energy sector 1.1. Of which: coal mines 1.2. Of which: oil and gas extraction 1.3. Of which: coke ovens 1.4. Of which: blast furnaces 1.5. Of which: gasworks 1.6. Of which: not elsewhere specified \u2014 energy 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector 3.1. Of which: pipeline transport 3.2. Of which: not elsewhere specified \u2014 transport 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified \u2014 other 4.3. Units of measurement 1. Energy quantities 103 tonnes 2. Calorific values MJ/tonne 4.4. Derogations and exemptions Cyprus is exempted from reporting the aggregates defined in Section 4.2.3 under point 4 (Other sectors) and point 5 (Total non-energy use); only the total values shall be applicable. Cyprus has a derogation of 3 years following the date of entry into force of this Regulation, for reporting the aggregates defined in Section 4.2.3 under point 2 (Industry sector) and point 3 (Transport sector); only the total values shall be applicable during this derogation period. 5. RENEWABLE ENERGY AND ENERGY FROM WASTE 5.1. Applicable energy products Unless otherwise specified this data collection applies to all of the following energy products: Energy product Definition 1. Hydro power Potential and kinetic energy of water converted into electricity in hydroelectric plants. Pumped storage must be included. Production must be reported for plant sizes of < 1 MW, 1 to < 10 MW, \u2265 10 MW and from pumped storage. 2. Geothermal Energy available as heat emitted from within the earth's crust, usually in the form of hot water or steam. This energy production is the difference between the enthalpy of the fluid produced in the production borehole and that of the fluid eventually disposed of. It is exploited at suitable sites: \u2014 for electricity generation using dry steam or high enthalpy brine after flashing, \u2014 directly as heat for district heating, agriculture etc. 3. Solar energy Solar radiation exploited for hot water production and electricity generation. This energy production is the heat available to the heat transfer medium, i.e. the incident solar energy less the optical and collectors' losses. Passive solar energy for the direct heating, cooling and lighting of dwellings or other buildings is not included. 3.1. Of which: solar photovoltaic Sunlight converted into electricity by the use of solar cells usually made of semi-conducting material which exposed to light will generate electricity. 3.2. Of which: solar thermal Heat from solar radiation; can consist of: (a) solar thermal-electric plants; or (b) equipment for the production of domestic hot water or for the seasonal heating of swimming pools (e.g. flat plate collectors, mainly of the thermosyphon type). 4. Tide, wave, ocean Mechanical energy derived from tidal movement, wave motion or ocean current and exploited for electricity generation. 5. Wind Kinetic energy of wind exploited for electricity generation in wind turbines. 6. Industrial waste (non-renewable) Report wastes of industrial non-renewable origin (solids or liquids) combusted directly for the production of electricity and/or heat. The quantity of fuel used should be reported on a net calorific value basis. Renewable industrial waste should be reported in the solid biomass, biogas and/or liquid biofuels categories. 7. Municipal waste Wastes produced by households, hospitals and the tertiary sector incinerated at specific installations, on a net calorific value basis. 7.1. Of which: renewable The portion of municipal waste which is of biological origin. 7.2. Of which: non-renewable The portion of municipal waste which is of non-biological origin. 8. Solid biomass Covers organic, non-fossil material of biological origin which may be used as fuel for heat production or electricity generation. It comprises: 8.1. Of which: charcoal The solid residue of the destructive distillation and pyrolysis of wood and other vegetal material. 8.2. Of which: wood, wood wastes, other solid wastes Purpose-grown energy crops (poplar, willow etc.), a multitude of woody materials generated by an industrial process (wood/paper industry in particular) or provided directly by forestry and agriculture (firewood, wood chips, wood pellets, bark, sawdust, shavings, chips, black liquor etc.) as well as wastes such as straw, rice husks, nut shells, poultry litter, crushed grape dregs etc. Combustion is the preferred technology for these solid wastes. The quantity of fuel used should be reported on a net calorific value basis. 9. Biogas A gas composed principally of methane and carbon dioxide produced by anaerobic digestion of biomass. 9.1. Of which: landfill gas A biogas formed by the digestion of landfilled wastes. 9.2. Of which: sewage sludge gas A biogas produced from the anaerobic fermentation of sewage sludge. 9.3. Of which: other biogas Biogas produced from the anaerobic fermentation of animal slurries and of wastes in abattoirs, breweries and other agro-food industries. 10. Liquid biofuels The quantities of liquid biofuels reported in this category should relate to the quantities of biofuel and not to the total volume of liquids into which the biofuels are blended. For the particular case of imports and exports of liquid biofuels, only trade of quantities that have not been blended with transport fuels is concerned (i.e. in their pure form); trade of liquid biofuels blended to transport fuels should be reported in the oil data in Chapter 4. The following liquid biofuels are concerned: 10.1. Of which: biogasoline This category includes bioethanol (ethanol produced from biomass and/or the biodegradable fraction of waste), biomethanol (methanol produced from biomass and/or the biodegradable fraction of waste), bioETBE (ethyl-tertio-butyl-ether produced on the basis of bioethanol; the percentage by volume of bioETBE that is calculated as biofuel is 47 %) and bioMTBE (methyl-tertio-butyl-ether produced on the basis of biomethanol: the percentage by volume of bioMTBE that is calculated as biofuel is 36 %). 10.2. Of which: bio-diesels This category includes bio-diesel (a methyl-ester produced from vegetable or animal oil, of diesel quality), biodimethylether (dimethylether produced from biomass), Fischer-Tropsch (Fischer-Tropsch produced from biomass), cold extracted bio-oil (oil produced from oil seed through mechanical processing only) and all other liquid biofuels which are added to, blended with or used straight as transport diesel. 10.3. Of which: other liquid biofuels Liquid biofuels, used directly as fuel, not included in biogasoline or bio-diesels. 5.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. 5.2.1. Gross electricity and heat production Electricity and heat produced from the energy products mentioned in Section 5.1 (except for charcoal and including the total sum only of the liquid biofuels) must be declared, wherever applicable, separately: \u2014 for main activity producer plants and for autoproducer plants, \u2014 for electricity-only producing plants, for heat-only producing plants, and for combined heat and power (CHP) plants. 5.2.2. Supply and transformation sectors Quantities of energy products that are mentioned in Section 5.1 (except for hydro power, solar photovoltaic energy, energy from tides, waves and oceans and wind energy) and used in the supply and transformation sectors must be declared for the following aggregates: 1. Production 2. Imports 3. Exports 4. Stock changes A stock build is shown as a negative number and a stock draw is shown as a positive number. 5. Gross consumption 6. Statistical differences 7. Total transformation sector Quantities of renewables and wastes used for the conversion of primary forms of energy to secondary (e.g. landfill gases to electricity) or used for the transformation to derived energy products (e.g. biogas used for blended natural gas). 7.1. Of which: main activity producer electricity plants 7.2. Of which: main activity producer CHP plants 7.3. Of which: main activity producer heat plants 7.4. Of which: autoproducer electricity plants 7.5. Of which: autoproducer CHP plants 7.6. Of which: autoproducer heat plants 7.7. Of which: patent fuel plants Quantities of renewables and wastes used to produce patent fuel. Renewables and wastes used for heating and operation of equipment must be reported as consumption in the energy sector. 7.8. Of which: BKB/PB plants Quantities of renewables and wastes used to produce BKB. Renewables and wastes used for heating and operation of equipment must be reported as consumption in the energy sector. 7.9. Of which: gasworks gas Quantities of renewables and wastes used to produce gasworks gas. Renewables and wastes used for heating and operation of equipment must be reported as consumption in the energy sector. 7.10. Of which: for blended natural gas Quantities of biogases blended with natural gas. 7.11. Of which: for blending to motor gasoline/diesel Quantities of liquid biofuels which are not delivered for final consumption but are used with other petroleum products reported as per Chapter 4 of this Annex. 7.12. Of which: charcoal production plants Quantities of wood used for the production of charcoal. 7.13. Of which: not elsewhere specified \u2014 transformation 5.2.3. Energy sector Quantities of energy products that are mentioned in Section 5.1 (except for hydro power, solar photovoltaic energy, energy from tides, waves and oceans and wind energy) and used in the energy sector or for final consumption must be declared for the following aggregates: 1. Total energy sector Renewable energies and wastes consumed by the energy industry to support the transformation activity. For example renewable energies and wastes used for heating, lighting or operating pumps/compressors. Quantities of renewable energies and wastes transformed into another energy form should be reported under the transformation sector. 1.1. Of which: gasification plants 1.2. Of which: public electric, CHP and heat plants 1.3. Of which: coal mines 1.4. Of which: patent fuel plants 1.5. Of which: coke ovens 1.6. Of which: petroleum refineries 1.7. Of which: BKB/PB plants 1.8. Of which: gasworks gas 1.9. Of which: blast furnaces 1.10. Of which: charcoal production plants 1.11. Of which: not elsewhere specified 2. Distribution losses All losses occurred due to transport and distribution. 5.2.4. Energy end-use Quantities of energy products that are mentioned in Section 5.1 (except for hydro power, solar photovoltaic energy, energy from tides, waves and oceans and wind energy) must be declared for the following aggregates: 1. Final energy consumption 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector 3.1. Of which: rail 3.2. Of which: road 3.3. Of which: domestic navigation 3.4. Of which: not elsewhere specified \u2014 transport 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified \u2014 other 5.2.5. Technical characteristics of installations The following electricity generation capacities are to be declared as applicable at the end of the reported year: 1. Hydro power Capacity must be reported for plant sizes of < 1 MW, 1 to < 10 MW, \u2265 10 MW and from pumped storage, as well as for all sizes combined. Detailed plant sizes should be reported net of pumped storage. 2. Geothermal 3. Solar photovoltaic 4. Solar thermal 5. Tide, wave, ocean 6. Wind 7. Industrial waste (non-renewable) 8. Municipal waste 9. Wood, wood wastes, other solid wastes 10. Landfill gas 11. Sewage sludge gas 12. Other biogas 13. Liquid biofuels The total surface installed of solar collectors are to be declared. The following biofuel production capacities are to be declared: 1. Liquid biofuels 1.1. Of which: biogasoline 1.2. Of which: bio-diesels 1.3. Of which: other liquid biofuels 5.2.6. Inputs to autoproducers of electricity and heat generation Inputs to autoproducers of electricity and heat generation are to be declared separately for electricity-only plants, for CHP plants, and for heat-only plants. Quantities of energy products that are mentioned in Section 5.1 (except for hydro power, solar photovoltaic energy, energy from tides, waves and oceans and wind energy) must be declared for the following aggregates: 1. Total energy sector 1.1. Of which: gasification plants 1.2. Of which: coal mines 1.3. Of which: patent fuel plants 1.4. Of which: coke ovens 1.5. Of which: petroleum refineries 1.6. Of which: BKB/PB plants 1.7. Of which: gasworks gas 1.8. Of which: blast furnaces 1.9. Of which: charcoal production plants 1.10. Of which: not elsewhere specified 2. Industry sector 2.1. Of which: iron and steel 2.2. Of which: chemical and petrochemical 2.3. Of which: non-ferrous metals 2.4. Of which: non-metallic minerals 2.5. Of which: transport equipment 2.6. Of which: machinery 2.7. Of which: mining and quarrying 2.8. Of which: food, beverages and tobacco 2.9. Of which: pulp, paper and printing 2.10. Of which: wood and wood products 2.11. Of which: construction 2.12. Of which: textile and leather 2.13. Of which: not elsewhere specified \u2014 industry 3. Transport sector 3.1. Of which: rail 3.2. Of which: not elsewhere specified \u2014 transport 4. Other sectors 4.1. Of which: commercial and public services 4.2. Of which: residential 4.3. Of which: agriculture/forestry 4.4. Of which: fishing 4.5. Of which: not elsewhere specified \u2014 other 5.3. Calorific values Average net calorific values are to be declared for the following products: 1. Biogasoline 2. Bio-diesel 3. Other liquid biofuels 4. Charcoal 5.4. Units of measurement 1. Electricity generation MWh 2. Heat production TJ 3. Renewable energy products Biogasoline, bio-diesels and other liquid biofuels: tonnes Charcoal: 1 000 tonnes All others: TJ (on the basis of net calorific values). 4. Solar collectors' surface 1 000 m2 5. Plants capacity Biofuels: tonnes/year All others: MWe 6. Calorific values KJ/kg (net calorific value). 5.5. Derogations and exemptions Not applicable. 6. APPLICABLE PROVISIONS The following provisions apply for the data collection as described in all preceding chapters: 1. Reported period: A calendar year (1 January to 31 December). 2. Frequency: Annual. 3. Deadline for transmission of data: 30 November of the year following the reported period. 4. Transmission format and method: The transmission format shall conform to an appropriate interchange standard specified by Eurostat. Data shall be transmitted or uploaded by electronic means to the single entry point for data at Eurostat. ANNEX C MONTHLY ENERGY STATISTICS This Annex describes the scope, units, reported period, frequency, deadline and transmission modalities for the monthly collection of energy statistics. Annex A applies for explanations of terms for which a specific explanation is not supplied in this Annex. 1. SOLID FUELS 1.1. Applicable energy products Unless otherwise specified this data collection applies to all of the following energy products: Energy product Definition 1. Hard coal Black, combustible, solid, organic, fossil sediment with a gross calorific value greater than 24 MJ/kg in ash-free condition with the moisture content obtained at a temperature of 30 oC and a relative air humidity of 96 %. 2. Lignite Combustible, brown to black, organic fossil sediment with a gross calorific value lower than 24 MJ/kg in ash-free condition with the moisture content obtained at a temperature of 30 oC and a relative air humidity of 96 %. 2.1. Of which: black lignite Lignite with a moisture content of 20 to 25 % and an ash content of 9 to 13 %. Black lignite was formed in the secondary era. Within the Union, it is now produced only by France from deep mining in Provence. 2.2. Of which: brown coal Lignite with a moisture content of 40 to 70 % and an ash content normally between 2 and 6 %; the latter, however, may be as high as 12 % depending on the deposit. Brown coal was mainly formed in the tertiary era. This fuel is mostly mined in opencast workings. 3. Peat Soft, loose to compressed, natural, combustible sediment of vegetable origin with a high moisture content (up to 90 %), light to dark brown in colour. This definition is without prejudice to the definition of renewable energy sources in Directive 2001/77/EC and to the 2006 IPCC Guidelines for National Greenhouse Gas Inventories. 4. Patent fuel Patent fuels of hard coal are artefacts of specified shape produced by hot milling under pressure, with the addition of binding material (pitch). 5. Lignite briquettes Artefacts of even shape produced after crushing and drying of lignite, moulded under high pressure without the addition of binders. This includes dried lignite and lignite breeze. 6. Coke derived from hard coal Artificial solid fuel derived from hard coal and obtained by dry distillation of the coal in the total or partial absence of air. Includes: \u2014 hard coke: obtained by carbonisation at high temperatures, \u2014 semi-coke: obtained by carbonisation at low temperatures, \u2014 gasworks coke: produced in gasworks. 7. Lignite coke Solid residue obtained by dry distillation of lignite in the absence of air. 1.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. Annex A applies for explanations of terms for which a specific explanation is not supplied in this Annex. 1.2.1. Supply sector The following aggregates apply to hard coal, total and black lignite, brown coal and peat: 1. Production 2. Recovered products Slurries and waste-heap shale recovered by mines. 3. Imports 3.1. Of which: intra-EU imports 4. Exports 4.1. Of which: intra-EU exports 5. Stock changes Quantities held by mines and importers. Excludes consumer stocks (e.g. those held in power stations and coking plants) except stocks held by consumers who import directly. A stock build is shown as a negative number and a stock draw is shown as a positive number. 6. Calculated inland deliveries Total amount of product calculated to have been delivered for inland consumption. It is defined as: production + recovered products + imports - exports + stock changes 7. Observed internal deliveries Quantities delivered to the internal market. Equal to the total of the deliveries to the different types of consumers. A difference may occur between the calculated and observed deliveries. 7.1. Of which: producers' own use Internal use in production units. Excludes consumption in pit-head power stations, pit-head patent fuel plants, pit-head coke oven plants and deliveries to colliery staff. 7.2. Of which: main activity power stations 7.3. Of which: autoproducer power stations in coal mines 7.4. Of which: coking plants 7.5. Of which: patent fuel plants Quantities used for transformation in patent fuel plants (pithead and independent). 7.6. Of which: total industry (without iron and steel industry) 7.7. Of which: iron and steel industry 7.8. Of which: others (services, households, etc.) Quantities of fuel to households (including colliery coal supplied to workers in mines and associated plants) and services (administrations, shops, etc.) and also to sectors not elsewhere specified (district heating, transport, etc.). 8. Closing stocks 8.1. Of which: mines 8.2. Of which: importers 8.3. Of which: at coking plants Applies to hard coal only. The following aggregates apply to coke derived from hard coal, lignite coke, patent fuels and lignite briquettes: 1. Production 2. Imports 3. Exports 3.1. Of which: intra-EU exports 4. Stock change Quantities held in coking plants (coke) and patent fuel plants (patent fuels) as well as at the importers. Excludes consumers' stocks excepted stocks held by consumers which import directly. A stock build is shown as a negative number and a stock draw is shown as a positive number. 5. Calculated inland deliveries Total amount of product calculated to have been delivered for inland consumption. It is defined as: production + imports - exports + stock changes 6. Observed internal deliveries Quantities delivered to the internal market. Equal to the total of the deliveries to the different types of consumers. A difference may occur between the calculated and observed deliveries. 6.1. Of which: total industry (without iron and steel industry) 6.2. Of which: iron and steel industry 6.3. Of which: others (services, households, etc.) Quantities of fuel to households (including coke and patent fuels supplied to workers in mines and associated plants) and services (administrations, shops, etc.) 7. Closing stocks Stocks are the quantities held: \u2014 by coking plants (applicable only to coke of coal and lignite), \u2014 patent fuel plants (applicable only to patent fuels of coal and lignite), \u2014 importers. 1.2.2. Imports For lignite, lignite coke, patent fuels and lignite briquettes the total intra-EU and total extra-EU import quantities must be declared. For hard coal, imports must be declared from the following countries of origin: 1. Intra-EU import quantities 1.1. Of which: Germany 1.2. Of which: United Kingdom 1.3. Of which: Poland 1.4. Of which: other EU The relevant countries must be specified. 2. Extra-EU import quantities 2.1. Of which: USA 2.2. Of which: Australia 2.3. Of which: South Africa 2.4. Of which: CIS 2.4.1. From 2.4, of which: Russia 2.4.2. From 2.4, of which: Ukraine 2.5. Of which: Canada 2.6. Of which: Colombia 2.7. Of which: China 2.8. Of which: other extra-EU The relevant countries must be specified. 1.3. Units of measurement All product quantities are expressed in 103 tonnes. 1.4. Derogations and exemptions Not applicable. 2. ELECTRICITY 2.1. Applicable energy products This chapter covers electrical energy. 2.2. List of aggregates The following list of aggregates shall be declared. 2.2.1. Production sector For the following aggregates both gross and net quantities must be declared: 1. Total electricity production 1.1. Of which: nuclear 1.2. Of which: hydro 1.2.1. From 1.2, of which: part of hydro produced from pumped storage 1.3. Of which: geothermal 1.4. Of which: conventional thermal 1.5. Of which: wind Also the following quantities of electrical energy must be declared: 2. Imports 2.1. Of which: intra-EU imports 3. Exports 3.1. Of which: extra-EU exports 4. Used for pumped storage 5. Used for the internal market This is calculated as: total net production + imports - exports - used for pumped storage For the fuel consumption in main activity producer plants the following aggregates apply (refer to Annex B for the definitions of hard coal and lignite): 6. Total fuel consumption in main activity producer plants Total quantity of fuel consumed for the purpose of producing electricity and also for the production of heat to be sold to third parties exclusively. 6.1. Of which: hard coal 6.2. Of which: lignite 6.3. Of which: petroleum products 6.4. Of which: natural gas 6.5. Of which: derived gas (these are manufactured gases) 6.6. Of which: other fuels 2.2.2. Fuel stocks in main activity producers By main activity producers are meant public utilities generating electricity by using fuels. The following closing stocks (stocks at the end of the reported month) must be declared: 1. Hard coal 2. Lignite 3. Petroleum products 2.3. Units of measurement 1. Energy quantities Electricity: GWh Hard coal, lignite and petroleum products: both in 103 tonnes and in TJ on the basis of the net calorific value. Natural gas and derived gases: TJ on the basis of the gross calorific value. Other fuels: TJ on the basis of the net calorific value. Nuclear heat: TJ. 2. Stocks 103 tonnes 2.4. Derogations and exemptions Not applicable. 3. OIL AND PETROLEUM PRODUCTS 3.1. Applicable energy products Unless otherwise specified this data collection applies to all of the following energy products, for which the definitions in Annex B Chapter 4 apply: crude oil, NGL, refinery feedstocks, other hydrocarbons, refinery gas (not liquefied), ethane, LPG, naphtha, motor gasoline, aviation gasoline, gasoline type jet fuel (naphtha type jet fuel or JP4), kerosene type jet fuel, other kerosene, gas/diesel oil (distillate fuel oil), transport diesel, heating and other gasoil, fuel oil (both low and high sulphur content), white spirit and SBP, lubricants, bitumen, paraffin waxes and petroleum coke. Where applicable, motor gasoline must be declared in two categories namely: \u2014 Unleaded motor gasoline: motor gasoline where lead compounds have not been added to enhance octane rating. It may contain traces of organic lead. \u2014 Leaded motor gasoline: motor gasoline with TEL and/or TML added to enhance octane rating. \u2018Other products\u2019 include both the quantities that correspond to the definition in Annex B Chapter 4 and in addition the quantities of white spirit and SBP, lubricants, bitumen and paraffin waxes; these products must not be declared separately. 3.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. 3.2.1. Supply sector The following table applies only to crude oil, NGL, refinery feedstocks, additives/oxygenates, biofuels and other hydrocarbons only: 1. Indigenous production Not applicable for refinery feedstocks. 2. From other sources Additives, biofuels and other hydrocarbons, the production of which has already been covered in other fuel balances. Not applicable for crude oil, NGL and refinery feedstocks. 3. Backflows from petrochemical sector Finished or semi-finished products which are returned from final consumers to refineries for processing, blending or sale. They are usually by-products of petrochemical manufacturing. Only applicable for refinery feedstocks. 4. Products transferred Imported petroleum products which are reclassified as feedstocks for further processing in the refinery, without delivery to final consumers. Only applicable for refinery feedstocks. 5. Imports and exports Includes quantities of crude oil and products imported or exported under processing agreements (i.e. refining on account). Crude oil and NGLs should be reported as coming from the country of ultimate origin; refinery feedstocks and finished products should be reported as coming from the country of last consignment. Includes any gas liquids (e.g. LPG) extracted during the regasification of imported liquefied natural gas and petroleum products imported or exported directly by the petrochemical industry. Note: all trade of biofuels which have not been blended with transport fuels (i.e. in their pure form) should be reported in the Renewables Questionnaire. 6. Direct use Crude oil, NGL and other hydrocarbons used directly without being processed in petroleum refineries. Includes crude oil burned for electricity generation. 7. Stock changes A stock build is shown as a positive number and a stock draw is shown as a negative number. 8. Calculated refinery intake Total amount of product calculated to have entered the refinery process. It is defined as: indigenous production + from other sources + backflows from industry + products transferred + imports - exports - direct use - stock changes. 9. Statistical differences Defined as the calculated refinery intake minus the observed one. 10. Observed refinery intake Amounts measured as input to refineries. 11. Refinery losses The difference between refinery intake (observed) and gross refinery output. Losses may occur during the distillation processes due to evaporation. Reported losses are positive. There may be volumetric gains but no gains in mass. 12. Production of oxygenates That part of production or from other sources which is ethers such as MTBE (methyl tertiary butyl ether), TAME (tertiary amyl methyl ether), alcohols such as ethanol and esters and which are used for blending into gasoline and gasoil. The following table does not apply to refinery feedstocks nor to additives/oxygenates: 1. Primary product receipts Includes quantities of indigenous or imported crude oil (including condensate) and indigenous NGL used directly without being processed in a petroleum refinery and quantities of backflows from the petrochemical industry which, although not primary fuel, are used directly. 2. Gross refinery output Production of finished products at a refinery or blending plant. Excludes refinery losses, but includes refinery fuel. 3. Recycled products Finished products which pass a second time through the marketing network, after having been once delivered to final consumers (e.g. used lubricants which are reprocessed). These quantities should be distinguished from petrochemical backflows. 4. Refinery fuel Petroleum products consumed in support of the operation of a refinery. Excludes products used by oil companies outside the refining process, e.g. bunkers or oil tankers. Includes fuels used for the production at the refineries of electricity and heat sold. 5. Imports and exports 6. International marine bunkers 7. Interproduct transfers Quantities reclassified either because their specification has changed or because they are blended into another product. A negative entry for one product is compensated by a positive entry (or several entries) for one or several products and vice versa; the total net effect should be zero. 8. Products transferred Imported petroleum products which are reclassified as feedstocks for further processing in the refinery, without delivery to final consumers. 9. Stock changes A stock build is shown as a positive number and a stock draw is shown as a negative number. 10. Calculated gross inland deliveries This is defined as: primary product receipts + gross refinery output + recycled products - refinery fuel + imports - exports - international marine bunkers + interproduct transfers - products transferred - stock changes. 11. Statistical difference Defined as the calculated gross inland delivery minus the observed one. 12. Observed gross inland deliveries The observed delivery of finished petroleum products from primary sources (e.g. refineries, blending plants, etc.) to the inland market. This figure may differ from the calculated figure due, for example, to differences in coverage and/or differences of definition in different reporting systems. 12.1. Of which: deliveries to international civil aviation 12.2. Of which: deliveries to public power plants 12.3. Of which: deliveries of automotive LPG 12.4. Of which: deliveries (gross) to petrochemical sector 13. Backflows from petrochemical sector to refineries 14. Total net inland deliveries 3.2.2. Stocks The following opening and closing stocks must be declared for all energy products except for refinery gas: 1. Stocks on national territory Stocks in the following locations: refinery tanks, bulk terminals, pipeline tankage, barges and coastal tankers (when port of departure and destination are in the same country), tankers in a port of a member country (if their cargo is to be discharged at the port), inland ship bunkers. Exclude stocks of oil held in pipelines, in rail tanks cars, in truck tanks cars, in sea-going ships' bunkers, in service stations, in retail stores and in bunkers at sea. 2. Stocks held for other countries under bilateral government agreements Stocks on national territory which belong to another country and to which the access is guaranteed by an agreement between the respective governments. 3. Stocks with known foreign destination Stocks not included in point 2 on national territory which belong to and are destined for another country. These stocks may be located inside or outside bonded areas. 4. Other stocks held in bonded areas Includes stocks neither included in point 2 nor 3 irrespective of whether they have received customs clearance or not. 5. Stocks held by major consumers Include stocks which are subject to government control. This definition does not include other consumer stocks. 6. Stocks held on board incoming ocean vessels in port or at mooring Stocks irrespective of whether they have been cleared by customs or not. This category excludes stocks on board vessels at high seas. Includes oil in coastal tankers if both their port of departure and destination are in the same country. In the case of incoming vessels with more than one port of unloading, only report the amount to be unloaded in the reporting country. 7. Stocks held by government on national territory Includes non-military stocks held within the national territory by government, which are government-owned or controlled and held exclusively for emergency purposes. Excludes stocks held by state oil companies or electric utilities or stocks held directly by oil companies on behalf of governments. 8. Stocks held by stock holding organisation on national territory Stocks held by both public and private corporations established to maintain stocks exclusively for emergency purposes. Excludes mandatory stocks held by private companies. 9. All other stocks held on national territory All other stocks satisfying the conditions described in point 1 above. 10. Stocks held abroad under bilateral government agreements Stocks belonging to the reporting country but held in another country, to which access is guaranteed by an agreement between the respective governments. 10.1. Of which: government stocks 10.2. Of which: holding organisation's stocks 10.3. Of which: other stocks 11. Stocks held abroad designated definitely for import stocks Stocks not included in category 10 which belong to the reporting state but which are held in another state and awaiting import there. 12. Other stocks in bonded areas Other stocks in the national territory not included in the above categories. 13. Pipeline fill Oil (crude oil and petroleum products) contained in pipelines, necessary to maintain the flow in the pipelines. In addition, a breakdown of quantities per corresponding country must be declared for: \u2014 closing stocks held for other countries under bilateral government agreements, \u2014 other closing stocks with known foreign destination, \u2014 closing stocks held abroad under bilateral government agreements, \u2014 other closing stocks held abroad designated definitely for import into the reporting country. By opening stocks are meant the stocks on the last day of the month preceding the reported one. By closing stocks are meant the stocks on the last day of the reported month. 3.2.3. Imports and exports Imports by country of origin, and exports by country of destination. 3.3. Units of measurement Energy quantities: 103 tonnes. 3.4. Geographical notes For statistical reporting purposes only, the clarifications of Annex A Chapter 1 apply with the following specific exceptions: 1. Denmark includes the Faeroe Islands and Greenland. 2. Switzerland includes Liechtenstein. 3.5. Derogations and exemptions Not applicable. 4. NATURAL GAS 4.1. Applicable energy products Natural gas is defined in Annex B Chapter 2. 4.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. 4.2.1. Supply sector 1. Indigenous production All dry marketable production within national boundaries, including offshore production. Production is measured after purification and extraction of NGLs and sulphur. Excludes extraction losses and quantities reinjected, vented or flared. Includes quantities used within the natural gas industry; in gas extraction, pipeline systems and processing plants. 2. Imports 3. Exports 4. Stock changes A stock build is shown as a positive number and a stock draw is shown as a negative number. 5. Calculated gross inland deliveries This is defined as: indigenous production + imports - exports - stock change. 6. Statistical difference Defined as the calculated gross inland delivery minus the observed one. 7. Observed gross inland deliveries Includes gas used by the gas industry for heating and operation of their equipment (i.e. consumption in gas extraction, in the pipeline system and in processing plants) and losses in distribution. 8. Opening and closing levels of stocks held on national territory Quantities stored in special storage facilities (depleted gas and/or oil field, aquifer, salt cavity, mixed caverns or other) as well as liquefied natural gas storage. By opening stocks are meant the stocks on the last day of the month preceding the reported one. By closing stocks are meant the stocks on the last day of the reported month. 9. Own use and losses of the natural gas industry Own used quantities by the gas industry for heating and operation of its equipment (i.e. consumption in gas extraction, in the pipeline system and in processing plants). Includes losses in distribution. 4.2.2. Imports and exports Imports by country of origin, and exports by country of destination. 4.3. Units of measurement Quantities must be declared in two units: \u2014 in physical quantity, in 106 m3 assuming reference gas conditions (15 oC, 101,325 kPa), \u2014 in energy content, i.e. in TJ, based on the gross calorific value. 4.4. Derogations and exemptions Not applicable. 5. APPLICABLE PROVISIONS The following provisions apply for the data collection as described in all preceding chapters: 1. Reported period: A calendar month. 2. Frequency: Monthly. 3. Deadline for transmission of data: Within three months following the reported month. 4. Transmission format and method: The transmission format shall conform to an appropriate interchange standard specified by Eurostat. Data shall be transmitted or uploaded by electronic means to the single entry point for data at Eurostat. ANNEX D SHORT-TERM MONTHLY STATISTICS This Annex describes the scope, units, reported period, frequency, deadline and transmission modalities for the short-term monthly collection of statistical data. Annex A applies for explanations of terms for which a specific explanation is not supplied in this Annex. 1. NATURAL GAS 1.1. Applicable energy products This chapter covers natural gas only. Natural gas is defined in Chapter 2 of Annex B. 1.2. List of aggregates The following list of aggregates shall be declared. 1. Production 2. Imports 3. Exports 4. Stock change A stock build is shown as a negative number and a stock draw is shown as a positive number. 5. Supply This is calculated as: production + imports - exports + stock change. 1.3. Units of measurement Quantities of natural gas must be declared in TJ, based on the gross calorific value. 1.4. Other applicable provisions 1. Reported period: A calendar month. 2. Frequency: Monthly. 3. Deadline for transmission of data: Within one month following the reported month. 4. Transmission format and method: The transmission format shall conform to an appropriate interchange standard specified by Eurostat. Data shall be transmitted or uploaded by electronic means to the single entry point for data at Eurostat. 1.5. Derogations and exemptions Germany is exempted from this data collection. 2. ELECTRICITY 2.1. Applicable energy products This chapter covers electricity only. 2.2. List of aggregates The following list of aggregates shall be declared. 1. Total electricity production Total gross quantity of electricity generated. Includes own consumption of power plants. 2. Imports 3. Exports 4. Gross electricity supply This is calculated as: total electricity production + imports - exports. 2.3. Units of measurement Energy quantities must be expressed in GWh. 2.4. Other applicable provisions 1. Reported period: A calendar month. 2. Frequency: Monthly. 3. Deadline for transmission of data: Within one month following the reported month. 4. Transmission format and method: The transmission format shall conform to an appropriate interchange standard specified by Eurostat. Data shall be transmitted or uploaded by electronic means to the single entry point for data at Eurostat. 2.5. Derogations and exemptions Germany is exempted from this data collection. 3. OIL AND PETROLEUM PRODUCTS This data collection is commonly known as the \u2018JODI Questionnaire\u2019. 3.1. Applicable energy products Unless otherwise specified, this data collection applies to all of the following energy products, for which the definitions in Chapter 4 of Annex B apply: crude oil, LPG, gasoline (which is the sum of motor gasoline and aviation gasoline), kerosene (which is the sum of kerosene type jet fuel and other kerosene), gas/diesel oil and fuel oil (both low and high sulphur content). In addition, this data collection also applies to \u2018total oil\u2019, by which is meant the sum of all these products except crude oil, and must also include other petroleum products such as refinery gas, ethane, naphtha, petroleum coke, white spirit and SBP, paraffin waxes, bitumen, lubricants and others. 3.2. List of aggregates The following list of aggregates shall be declared for all energy products listed in the previous paragraph unless otherwise specified. 3.2.1. Supply sector The following table applies only to crude oil: 1. Production 2. Imports 3. Exports 4. Closing stock 5. Stock change A stock build is shown as a positive number and a stock draw is shown as a negative number. 6. Refinery intake Observed refinery throughput. The following table applies to crude oil, LPG, gasoline, kerosene, gas/diesel oil, fuel oil and total oil: 1. Refinery output Gross output, including refinery fuel. 2. Imports 3. Exports 4. Closing stock 5. Stock change A stock build is shown as a positive number and a stock draw is shown as a negative number. 6. Demand Deliveries or sales to the inland market (domestic consumption) plus refinery fuel plus international marine and aviation bunkers. Demand for total oil includes crude. 3.3. Units of measurement Energy quantities: 103 tonnes 3.4. Other applicable provisions 1. Reported period: A calendar month. 2. Frequency: Monthly. 3. Deadline for transmission of data: Within 25 days following the reported month. 4. Transmission format and method: The transmission format shall conform to an appropriate interchange standard specified by Eurostat. Data shall be transmitted or uploaded by electronic means to the single entry point for data at Eurostat. 3.5. Derogations and exemptions Not applicable.", "summary": "Common system for the production of energy statistics Common system for the production of energy statistics SUMMARY OF Regulation (EC) No 1099/2008 on EU energy statistics WHAT IS THE AIM OF THE REGULATION? It sets up a system to produce EU-wide statistics on energy products* and their aggregates*. It also applies to European Economic Area countries. It covers the entire process of collecting, transmitting, evaluating and disseminating the data. KEY POINTS Terminology Technical terms are defined and clarified in the regulation\u2019s Annex A. Data sources EU countries are required to compile statistics concerning energy products and their aggregates from the following sources: specific surveys addressed to the primary* and transformed* energy producers and traders, distributors and transporters, importers and exporters of energy products; other surveys addressed to final energy users in the sectors of manufacturing industry, transport, and other sectors, including households; other estimation procedures or other sources, including administrative sources, such as regulators of the electricity and gas markets. Transmission and dissemination of data Reporting countries must transmit national statistics to the European Commission (Eurostat) as laid down in the regulation\u2019s annexes: annually for energy statistics in Annex B; monthly for energy statistics in Annex C (data must be transmitted to Eurostat within 55 days following the reported month); short-term monthly for the energy statistics in Annex D (data must be transmitted to Eurostat within one calendar month of the month reported). The transmission arrangements, including the applicable time limits, and any exceptions and exemptions are set out in the annexes. Over time, these arrangements may be modified by the Commission. Eurostat must disseminate annual statistics no later than 31 January of the second year after the reported period. Quality assessment and reports EU countries are responsible for the quality of the data they transmit to Eurostat. In particular, they must ensure that energy data they declare under this regulation matches data they declare with regard to the EU Monitoring Mechanism Regulation. The Commission (Eurostat) assesses the quality of data from several perspectives including their relevance, punctuality, accessibility, clarity and comparability. Every 5 years, EU countries must provide Eurostat with a report on the quality of the data transmitted, as well as on any changes in methodology that have been made. Annual nuclear statistics As of 2009, EU countries have been preparing statistics on the nuclear sector. The set of statistics collected concerns the civil use of nuclear energy. Renewable energy and final energy consumption statistics To ensure better quality and more comprehensive renewable energy and final energy consumption statistics, the Commission, with the EU countries, is reviewing and revising the methodologies used in their production. In particular, countries are required to transmit more disaggregated* data for final energy consumption in households as from reference year 2015 and more detailed data on renewable energies as from reference year 2017. Implementing legislation The Commission is granted the power to adopt supplementary legislation designed to implement this regulation. Committee The Commission (Eurostat) is assisted and advised by the European Statistical System Committee, a committee composed of representatives from EU countries and chaired by the Commission. FROM WHEN DOES THE REGULATION APPLY? It has applied since 4 December 2008. BACKGROUND For more information, see: Energy \u2014 overview (Eurostat). KEY TERMS Energy products: combustible fuels, heat, renewable energy, electricity or any other form of energy. Aggregates: data aggregated at national level on the treatment or use of energy products, namely: production, trade, stocks, transformation and consumption, and structural characteristics of the energy system, such as installed capacities for electricity generation or production capacities for oil products. Primary energy: energy sources that can be used directly in their natural state, e.g. coal, oil, natural gas, biomass, solar, wind or nuclear heat. Transformed energy: energy that derives from a primary source but can only be used in its transformed state, e.g. electricity from a coal- or oil-powered plant. Disaggregated data: data that are available in separate component parts (household water heating, household lighting, etc.) MAIN DOCUMENT Regulation (EC) No 1099/2008 of the European Parliament and of the Council of 22 October 2008 on energy statistics (OJ L 304, 14.11.2008, pp. 1-62) Successive amendments to Regulation (EC) No 1099/2008 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Regulation (EU) 2017/2010 of 9 November 2017 amending Regulation (EC) No 1099/2008 of the European Parliament and of the Council on energy statistics, as regards the updates for the annual and monthly energy statistics (OJ L 292, 10.11.2017, pp. 3\u201354) Commission Implementing Decision (EU) 2015/1504 of 7 September 2015 granting derogations to certain Member States as regards the provision of statistics pursuant to Regulation (EC) No 1099/2008 of the European Parliament and of the Council on energy statistics (OJ L 235, 9.9.2015, pp. 24-25) Commission Regulation (EU) No 431/2014 of 24 April 2014 amending Regulation (EC) No 1099/2008 of the European Parliament and of the Council on energy statistics, as regards the implementation of annual statistics on energy consumption in households (OJ L 131, 1.5.2014, pp. 1-50) Commission Regulation (EU) No 147/2013 of 13 February 2013 amending Regulation (EC) No 1099/2008 of the European Parliament and of the Council on energy statistics, as regards the implementation of updates for the monthly and annual energy statistics (OJ L 50, 22.2.2013, pp. 1-58) last update 10.11.2017"}
{"article": "28.2.2011 EN Official Journal of the European Union L 55/1 REGULATION (EU) No 181/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 February 2011 concerning the rights of passengers in bus and coach transport and amending Regulation (EC) No 2006/2004 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure, in the light of the joint text approved by the Conciliation Committee on 24 January 2011 (2), Whereas: (1) Action by the Union in the field of bus and coach transport should aim, among other things, at ensuring a high level of protection for passengers, that is comparable with other modes of transport, wherever they travel. Moreover, full account should be taken of the requirements of consumer protection in general. (2) Since the bus or coach passenger is the weaker party to the transport contract, all passengers should be granted a minimum level of protection. (3) Union measures to improve passengers\u2019 rights in the bus and coach transport sector should take account of the specific characteristics of this sector, which consists largely of small- and medium-sized undertakings. (4) Passengers and, as a minimum, persons whom the passenger had, or would have had, a legal duty to maintain should enjoy adequate protection in the event of accidents arising out of the use of the bus or coach, taking into account Directive 2009/103/EC of the European Parliament and of the Council of 16 September 2009 relating to insurance against civil liability in respect of the use of motor vehicles and the enforcement of the obligation to insure against such liability (3). (5) In choosing the national law applicable to compensation for death, including reasonable funeral expenses, or personal injury as well as for loss of or damage to luggage due to accidents arising out of the use of the bus or coach, Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) (4) and Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (5) should be taken into account. (6) Passengers should, in addition to compensation in accordance with applicable national law in the event of death or personal injury or loss of or damage to luggage due to accidents arising out of the use of the bus or coach, be entitled to assistance with regard to their immediate practical needs following an accident. Such assistance should include, where necessary, first aid, accommodation, food, clothes and transport. (7) Bus and coach passenger services should benefit citizens in general. Consequently, disabled persons and persons with reduced mobility, whether caused by disability, age or any other factor, should have opportunities for using bus and coach services that are comparable to those of other citizens. Disabled persons and persons with reduced mobility have the same rights as all other citizens with regard to free movement, freedom of choice and non-discrimination. (8) In the light of Article 9 of the United Nations Convention on the Rights of Persons with Disabilities and in order to give disabled persons and persons with reduced mobility opportunities for bus and coach travel comparable to those of other citizens, rules for non-discrimination and assistance during their journey should be established. Those persons should therefore be accepted for carriage and not refused transport on the grounds of their disability or reduced mobility, except for reasons which are justified on the grounds of safety or of the design of vehicles or infrastructure. Within the framework of relevant legislation for the protection of workers, disabled persons and persons with reduced mobility should enjoy the right to assistance at terminals and on board vehicles. In the interest of social inclusion, the persons concerned should receive the assistance free of charge. Carriers should establish access conditions, preferably using the European standardisation system. (9) In deciding on the design of new terminals, and as part of major refurbishments, terminal managing bodies should endeavour to take into account the needs of disabled persons and persons with reduced mobility, in accordance with \u2018design for all\u2019 requirements. In any case, terminal managing bodies should designate points where such persons can notify their arrival and need for assistance. (10) Similarly, without prejudice to current or future legislation on technical requirements for buses and coaches, carriers should, where possible, take those needs into account when deciding on the equipment of new and newly refurbished vehicles. (11) Member States should endeavour to improve existing infrastructure where this is necessary to enable carriers to ensure access for disabled persons and persons with reduced mobility as well as to provide appropriate assistance. (12) In order to respond to the needs of disabled persons and persons with reduced mobility, staff should be adequately trained. With a view to facilitating the mutual recognition of national qualifications of drivers, disability awareness training could be provided as a part of the initial qualification or periodic training as referred to in Directive 2003/59/EC of the European Parliament and of the Council of 15 July 2003 on the initial qualification and periodic training of drivers of certain road vehicles for the carriage of goods or passengers (6). In order to ensure coherence between the introduction of the training requirements and the time-limits set out in that Directive, a possibility for exemption during a limited period of time should be allowed. (13) Organisations representative of disabled persons or persons with reduced mobility should be consulted or involved in preparing the content of the disability-related training. (14) Rights of bus and coach passengers should include the receipt of information regarding the service before and during the journey. All essential information provided to bus and coach passengers should also be provided, upon request, in alternative formats accessible to disabled persons and persons with reduced mobility, such as large print, plain language, Braille, electronic communications that can be accessed with adaptive technology, or audio tapes. (15) This Regulation should not restrict the rights of carriers to seek compensation from any person, including third parties, in accordance with the applicable national law. (16) Inconvenience experienced by passengers due to cancellation or significant delay of their journey should be reduced. To this end, passengers departing from terminals should be adequately looked after and informed in a way which is accessible to all passengers. Passengers should also be able to cancel their journey and have their tickets reimbursed or to continue their journey or to obtain re-routing under satisfactory conditions. If carriers fail to provide passengers with the necessary assistance, passengers should have the right to obtain financial compensation. (17) With the involvement of stakeholders, professional associations and associations of customers, passengers, disabled persons and persons with reduced mobility, carriers should cooperate in order to adopt arrangements at national or European level. Such arrangements should aim at improving the information, care and assistance offered to passengers whenever their travel is interrupted, in particular in the event of long delays or cancellation of travel, with a particular focus on passengers with special needs due to disability, reduced mobility, illness, elderly age and pregnancy, and including accompanying passengers and passengers travelling with young children. National enforcement bodies should be informed of those arrangements. (18) This Regulation should not affect the rights of passengers established by Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (7). This Regulation should not apply in cases where a package tour is cancelled for reasons other than cancellation of the bus or coach transport service. (19) Passengers should be fully informed of their rights under this Regulation, so that they can effectively exercise those rights. (20) Passengers should be able to exercise their rights by means of appropriate complaint procedures implemented by carriers or, as the case may be, by submission of complaints to the body or bodies designated to that end by the relevant Member State. (21) Member States should ensure compliance with this Regulation and designate a competent body or bodies to carry out supervision and enforcement tasks. This does not affect the rights of passengers to seek legal redress from courts under national law. (22) Taking into account the procedures established by Member States for the submission of complaints, a complaint concerning assistance should preferably be addressed to the body or bodies designated for the enforcement of this Regulation in the Member State where the boarding point or alighting point is situated. (23) Member States should promote the use of public transport and the use of integrated information and integrated tickets in order to optimise the use and interoperability of the various transport modes and operators. (24) Member States should lay down penalties applicable to infringements of this Regulation and ensure that those penalties are applied. Those penalties should be effective, proportionate and dissuasive. (25) Since the objective of this Regulation, namely to ensure an equivalent level of protection of and assistance to passengers in bus and coach transport throughout the Member States, cannot sufficiently be achieved by the Member States and can therefore by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (26) This Regulation should be without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (8). (27) The enforcement of this Regulation should be based on Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection law (the Regulation on consumer protection cooperation) (9). That Regulation should therefore be amended accordingly. (28) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, as referred to in Article 6 of the Treaty on European Union, bearing in mind also Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin (10) and Council Directive 2004/113/EC of 13 December 2004 implementing the principle of equal treatment between men and women in the access to and supply of goods and services (11), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes rules for bus and coach transport as regards the following: (a) non-discrimination between passengers with regard to transport conditions offered by carriers; (b) rights of passengers in the event of accidents arising out of the use of the bus or coach resulting in death or personal injury or loss of or damage to luggage; (c) non-discrimination and mandatory assistance for disabled persons and persons with reduced mobility; (d) rights of passengers in cases of cancellation or delay; (e) minimum information to be provided to passengers; (f) handling of complaints; (g) general rules on enforcement. Article 2 Scope 1. This Regulation shall apply to passengers travelling with regular services for non-specified categories of passengers where the boarding or the alighting point of the passengers is situated in the territory of a Member State and where the scheduled distance of the service is 250 km or more. 2. As regards the services referred to in paragraph 1 but where the scheduled distance of the service is shorter than 250 km, Article 4(2), Article 9, Article 10(1), point (b) of Article 16(1), Article 16(2), Article 17(1) and (2), and Articles 24 to 28 shall apply. 3. In addition, with the exception of Articles 9 to 16, Article 17(3), and Chapters IV, V and VI, this Regulation shall apply to passengers travelling with occasional services where the initial boarding point or the final alighting point of the passenger is situated in the territory of a Member State. 4. With the exception of Article 4(2), Article 9, Article 10(1), point (b) of Article 16(1), Article 16(2), Article 17(1) and (2), and Articles 24 to 28, Member States may, on a transparent and non-discriminatory basis, exempt domestic regular services from the application of this Regulation. Such exemptions may be granted as from the date of application of this Regulation for a period no longer than 4 years, which may be renewed once. 5. For a maximum period of 4 years from the date of application of this Regulation, Member States may, on a transparent and non-discriminatory basis, exempt from the application of this Regulation particular regular services because a significant part of such regular services, including at least one scheduled stop, is operated outside the Union. Such exemptions may be renewed once. 6. Member States shall inform the Commission of exemptions of different types of services granted pursuant to paragraphs 4 and 5. The Commission shall take appropriate action if such an exemption is deemed not to be in accordance with the provisions of this Article. By 2 March 2018, the Commission shall submit to the European Parliament and the Council a report on exemptions granted pursuant to paragraphs 4 and 5. 7. Nothing in this Regulation shall be understood as conflicting with or introducing additional requirements to those in current legislation on technical requirements for buses or coaches or infrastructure or equipment at bus stops and terminals. 8. This Regulation shall not affect the rights of passengers under Directive 90/314/EEC and shall not apply in case where a package tour referred to in that Directive is cancelled for reasons other than cancellation of a regular service. Article 3 Definitions For the purposes of this Regulation, the following definitions shall apply: (a) \u2018regular services\u2019 means services which provide for the carriage of passengers by bus or coach at specified intervals along specified routes, passengers being picked up and set down at predetermined stopping points; (b) \u2018occasional services\u2019 means services which do not fall within the definition of regular services and the main characteristic of which is the carriage by bus or coach of groups of passengers constituted on the initiative of the customer or the carrier himself; (c) \u2018transport contract\u2019 means a contract of carriage between a carrier and a passenger for the provision of one or more regular or occasional services; (d) \u2018ticket\u2019 means a valid document or other evidence of a transport contract; (e) \u2018carrier\u2019 means a natural or legal person, other than a tour operator, travel agent or ticket vendor, offering transport by regular or occasional services to the general public; (f) \u2018performing carrier\u2019 means a natural or legal person other than the carrier, who actually performs the carriage wholly or partially; (g) \u2018ticket vendor\u2019 means any intermediary concluding transport contracts on behalf of a carrier; (h) \u2018travel agent\u2019 means any intermediary acting on behalf of a passenger for the conclusion of transport contracts; (i) \u2018tour operator\u2019 means an organiser or retailer, other than the carrier, within the meaning of Article 2(2) and (3) of Directive 90/314/EEC; (j) \u2018disabled person\u2019 or \u2018person with reduced mobility\u2019 means any person whose mobility when using transport is reduced as a result of any physical disability (sensory or locomotory, permanent or temporary), intellectual disability or impairment, or any other cause of disability, or as a result of age, and whose situation needs appropriate attention and adaptation to his particular needs of the services made available to all passengers; (k) \u2018access conditions\u2019 means relevant standards, guidelines and information on the accessibility of buses and/or of designated terminals including their facilities for disabled persons or persons with reduced mobility; (l) \u2018reservation\u2019 means a booking of a seat on board a bus or coach for a regular service at a specific departure time; (m) \u2018terminal\u2019 means a staffed terminal where according to the specified route a regular service is scheduled to stop for passengers to board or alight, equipped with facilities such as a check-in counter, waiting room or ticket office; (n) \u2018bus stop\u2019 means any point other than a terminal where according to the specified route a regular service is scheduled to stop for passengers to board or alight; (o) \u2018terminal managing body\u2019 means an organisational entity in a Member State responsible for the management of a designated terminal; (p) \u2018cancellation\u2019 means the non-operation of a regular service which was previously scheduled; (q) \u2018delay\u2019 means a difference between the time the regular service was scheduled to depart in accordance with the published timetable and the time of its actual departure. Article 4 Tickets and non-discriminatory contract conditions 1. Carriers shall issue a ticket to the passenger, unless other documents give entitlement to transport. A ticket may be issued in an electronic format. 2. Without prejudice to social tariffs, the contract conditions and tariffs applied by carriers shall be offered to the general public without any direct or indirect discrimination based on the nationality of the final customer or on the place of establishment of the carriers, or ticket vendors within the Union. Article 5 Other performing parties 1. If the performance of the obligations under this Regulation has been entrusted to a performing carrier, ticket vendor or any other person, the carrier, travel agent, tour operator or terminal managing body, who has entrusted such obligations, shall nevertheless be liable for the acts and omissions of that performing party. 2. In addition, the party to whom the performance of an obligation has been entrusted by the carrier, travel agent, tour operator or terminal managing body shall be subject to the provisions of this Regulation with regard to the obligation entrusted. Article 6 Exclusion of waiver 1. Obligations to passengers pursuant to this Regulation shall not be limited or waived, in particular by a derogation or restrictive clause in the transport contract. 2. Carriers may offer contract conditions that are more favourable for the passenger than the conditions laid down in this Regulation. CHAPTER II COMPENSATION AND ASSISTANCE IN THE EVENT OF ACCIDENTS Article 7 Death or personal injury to passengers and loss of or damage to luggage 1. Passengers shall, in accordance with applicable national law, be entitled to compensation for death, including reasonable funeral expenses, or personal injury as well as to loss of or damage to luggage due to accidents arising out of the use of the bus or coach. In case of death of a passenger, this right shall as a minimum apply to persons whom the passenger had, or would have had, a legal duty to maintain. 2. The amount of compensation shall be calculated in accordance with applicable national law. Any maximum limit provided by national law to the compensation for death and personal injury or loss of or damage to luggage shall on each distinct occasion not be less than: (a) EUR 220 000 per passenger; (b) EUR 1 200 per item of luggage. In the event of damage to wheelchairs, other mobility equipment or assistive devices the amount of compensation shall always be equal to the cost of replacement or repair of the equipment lost or damaged. Article 8 Immediate practical needs of passengers In the event of an accident arising out of the use of the bus or coach, the carrier shall provide reasonable and proportionate assistance with regard to the passengers\u2019 immediate practical needs following the accident. Such assistance shall include, where necessary, accommodation, food, clothes, transport and the facilitation of first aid. Any assistance provided shall not constitute recognition of liability. For each passenger, the carrier may limit the total cost of accommodation to EUR 80 per night and for a maximum of 2 nights. CHAPTER III RIGHTS OF DISABLED PERSONS AND PERSONS WITH REDUCED MOBILITY Article 9 Right to transport 1. Carriers, travel agents and tour operators shall not refuse to accept a reservation from, to issue or otherwise provide a ticket to, or to take on board, a person on the grounds of disability or of reduced mobility. 2. Reservations and tickets shall be offered to disabled persons and persons with reduced mobility at no additional cost. Article 10 Exceptions and special conditions 1. Notwithstanding Article 9(1), carriers, travel agents and tour operators may refuse to accept a reservation from, to issue or otherwise provide a ticket to, or to take on board, a person on the grounds of disability or of reduced mobility: (a) in order to meet applicable safety requirements established by international, Union or national law, or in order to meet health and safety requirements established by the competent authorities; (b) where the design of the vehicle or the infrastructure, including bus stops and terminals, makes it physically impossible to take on board, alight or carry the disabled person or person with reduced mobility in a safe and operationally feasible manner. 2. In the event of a refusal to accept a reservation or to issue or otherwise provide a ticket on the grounds referred to in paragraph 1, carriers, travel agents and tour operators shall inform the person concerned about any acceptable alternative service operated by the carrier. 3. If a disabled person or a person with reduced mobility, who holds a reservation or has a ticket and has complied with the requirements of point (a) of Article 14(1), is nonetheless refused permission to board on the grounds of his disability or reduced mobility, that person and any accompanying person pursuant to paragraph 4 of this Article shall be offered the choice between: (a) the right to reimbursement, and where relevant a return service free of charge to the first point of departure, as set out in the transport contract, at the earliest opportunity; and (b) except where not feasible, continuation of the journey or re-routing by reasonable alternative transport services to the place of destination set out in the transport contract. The right to reimbursement of the money paid for the ticket shall not be affected by the failure to notify in accordance with point (a) of Article 14(1). 4. If a carrier, travel agent or tour operator refuses to accept a reservation from, to issue or otherwise provide a ticket to, or to take on board, a person on the grounds of disability or of reduced mobility for the reasons set out in paragraph 1, that person may request to be accompanied by another person of his own choosing who is capable of providing the assistance required by the disabled person or person with reduced mobility in order that the reasons set out in paragraph 1 no longer apply. Such an accompanying person shall be transported free of charge and, where feasible, seated next to the disabled person or person with reduced mobility. 5. When carriers, travel agents or tour operators have recourse to paragraph 1, they shall immediately inform the disabled person or person with reduced mobility of the reasons therefor, and, upon request, inform the person in question in writing within 5 working days of the request. Article 11 Accessibility and information 1. In cooperation with organisations representative of disabled persons or persons with reduced mobility, carriers and terminal managing bodies shall, where appropriate through their organisations, establish, or have in place, non-discriminatory access conditions for the transport of disabled persons and persons with reduced mobility. 2. The access conditions provided for in paragraph 1, including the text of international, Union or national laws establishing the safety requirements, on which these non-discriminatory access conditions are based, shall be made publicly available by carriers and terminal managing bodies physically or on the Internet, in accessible formats on request, in the same languages as those in which information is generally made available to all passengers. When providing this information particular attention shall be paid to the needs of disabled persons and persons with reduced mobility. 3. Tour operators shall make available the access conditions provided for in paragraph 1 which apply to journeys included in package travel, package holidays and package tours which they organise, sell or offer for sale. 4. The information on access conditions referred to in paragraphs 2 and 3 shall be physically distributed at the request of the passenger. 5. Carriers, travel agents and tour operators shall ensure that all relevant general information concerning the journey and the conditions of carriage is available in appropriate and accessible formats for disabled persons and persons with reduced mobility including, where applicable, online booking and information. The information shall be physically distributed at the request of the passenger. Article 12 Designation of terminals Member States shall designate bus and coach terminals where assistance for disabled persons and persons with reduced mobility shall be provided. Member States shall inform the Commission thereof. The Commission shall make available a list of the designated bus and coach terminals on the Internet. Article 13 Right to assistance at designated terminals and on board buses and coaches 1. Subject to the access conditions provided for in Article 11(1), carriers and terminal managing bodies shall, within their respective areas of competence, at terminals designated by Member States, provide assistance free of charge to disabled persons and persons with reduced mobility, at least to the extent specified in part (a) of Annex I. 2. Subject to the access conditions provided for in Article 11(1), carriers shall, on board buses and coaches, provide assistance free of charge to disabled persons and persons with reduced mobility, at least to the extent specified in part (b) of Annex I. Article 14 Conditions under which assistance is provided 1. Carriers and terminal managing bodies shall cooperate in order to provide assistance to disabled persons and persons with reduced mobility on condition that: (a) the person\u2019s need for such assistance is notified to carriers, terminal managing bodies, travel agents or tour operators at the latest 36 hours before the assistance is needed; and (b) the persons concerned present themselves at the designated point: (i) at the time stipulated in advance by the carrier which shall be no more than 60 minutes before the published departure time, unless a shorter period is agreed between the carrier and the passenger; or (ii) if no time is stipulated, no later than 30 minutes before the published departure time. 2. In addition to paragraph 1, disabled persons or persons with reduced mobility shall notify the carrier, travel agent or tour operator at the time of reservation or advance purchase of the ticket of their specific seating needs, provided that the need is known at that time. 3. Carriers, terminal managing bodies, travel agents and tour operators shall take all measures necessary to facilitate the receipt of notifications of the need for assistance made by disabled persons or persons with reduced mobility. This obligation shall apply at all designated terminals and their points of sale including sale by telephone and via the Internet. 4. If no notification is made in accordance with point (a) of paragraph 1 and paragraph 2, carriers, terminal managing bodies, travel agents and tour operators shall make every reasonable effort to ensure that the assistance is provided in such a way that the disabled person or person with reduced mobility is able to board the departing service, to change to the corresponding service or to alight from the arriving service for which he has purchased a ticket. 5. The terminal managing body shall designate a point inside or outside the terminal at which disabled persons or persons with reduced mobility can announce their arrival and request assistance. The point shall be clearly signposted and shall offer basic information about the terminal and assistance provided, in accessible formats. Article 15 Transmission of information to a third party If travel agents or tour operators receive a notification referred to in point (a) of Article 14(1) they shall, within their normal office hours, transfer the information to the carrier or terminal managing body as soon as possible. Article 16 Training 1. Carriers and, where appropriate, terminal managing bodies shall establish disability-related training procedures, including instructions, and ensure that: (a) their personnel, other than drivers, including those employed by any other performing party, providing direct assistance to disabled persons and persons with reduced mobility are trained or instructed as described in parts (a) and (b) of Annex II; and (b) their personnel, including drivers, who deal directly with the travelling public or with issues related to the travelling public, are trained or instructed as described in part (a) of Annex II. 2. A Member State may for a maximum period of 5 years from 1 March 2013 grant an exemption from the application of point (b) of paragraph 1 with regard to training of drivers. Article 17 Compensation in respect of wheelchairs and other mobility equipment 1. Carriers and terminal managing bodies shall be liable where they have caused loss of or damage to wheelchairs, other mobility equipment or assistive devices. The loss or damage shall be compensated by the carrier or terminal managing body liable for that loss or damage. 2. The compensation referred to in paragraph 1 shall be equal to the cost of replacement or repair of the equipment or devices lost or damaged. 3. Where necessary, every effort shall be undertaken to rapidly provide temporary replacement equipment or devices. The wheelchairs, other mobility equipment or assistive devices shall, where possible, have technical and functional features similar to those lost or damaged. Article 18 Exemptions 1. Without prejudice to Article 2(2), Member States may exempt domestic regular services from the application of all or some of the provisions of this Chapter, provided that they ensure that the level of protection of disabled persons and persons with reduced mobility under their national rules is at least the same as under this Regulation. 2. Member States shall inform the Commission of exemptions granted pursuant to paragraph 1. The Commission shall take appropriate action if such an exemption is deemed not to be in accordance with the provisions of this Article. By 2 March 2018, the Commission shall submit to the European Parliament and the Council a report on exemptions granted pursuant to paragraph 1. CHAPTER IV PASSENGER RIGHTS IN THE EVENT OF CANCELLATION OR DELAY Article 19 Continuation, re-routing and reimbursement 1. Where a carrier reasonably expects a regular service to be cancelled or delayed in departure from a terminal for more than 120 minutes or in the case of overbooking, the passenger shall immediately be offered the choice between: (a) continuation or re-routing to the final destination, at no additional cost and under comparable conditions, as set out in the transport contract, at the earliest opportunity; (b) reimbursement of the ticket price, and, where relevant, a return service by bus or coach free of charge to the first point of departure, as set out in the transport contract, at the earliest opportunity. 2. If the carrier fails to offer the passenger the choice referred to in paragraph 1, the passenger shall have the right to compensation amounting to 50 % of the ticket price, in addition to the reimbursement referred to in point (b) of paragraph 1. This sum shall be paid by the carrier within 1 month after the submission of the request for compensation. 3. Where the bus or coach becomes inoperable during the journey, the carrier shall provide either the continuation of the service with another vehicle from the location of the inoperable vehicle, or transport from the location of the inoperable vehicle to a suitable waiting point or terminal from where continuation of the journey becomes possible. 4. Where a regular service is cancelled or delayed in departure from a bus stop for more than 120 minutes, passengers shall have the right to the continuation or re-routing or reimbursement of the ticket price from the carrier, as referred to in paragraph 1. 5. The payment of reimbursement provided for in point (b) of paragraph 1 and paragraph 4 shall be made within 14 days after the offer has been made or request has been received. The payment shall cover the full cost of the ticket at the price at which it was purchased, for the part or parts of the journey not made, and for the part or parts already made if the journey no longer serves any purpose in relation to the passenger\u2019s original travel plan. In case of travel passes or season tickets the payment shall be equal to its proportional part of the full cost of the pass or ticket. The reimbursement shall be paid in money, unless the passenger accepts another form of reimbursement. Article 20 Information 1. In the event of cancellation or delay in departure of a regular service, passengers departing from terminals shall be informed by the carrier or, where appropriate, the terminal managing body, of the situation as soon as possible and in any event no later than 30 minutes after the scheduled departure time, and of the estimated departure time as soon as this information is available. 2. If passengers miss, according to the timetable, a connecting service due to a cancellation or delay, the carrier or, where appropriate, the terminal managing body, shall make reasonable efforts to inform the passengers concerned of alternative connections. 3. The carrier or, where appropriate, the terminal managing body, shall ensure that disabled persons and persons with reduced mobility receive the information required under paragraphs 1 and 2 in accessible formats. 4. Where feasible, the information required under paragraphs 1 and 2 shall be provided by electronic means to all passengers, including those departing from bus stops, within the time-limit stipulated in paragraph 1, if the passenger has requested this and has provided the necessary contact details to the carrier. Article 21 Assistance in case of cancelled or delayed departures For a journey of a scheduled duration of more than 3 hours the carrier shall, in case of cancellation or delay in departure from a terminal of more than 90 minutes, offer the passenger free of charge: (a) snacks, meals or refreshments in reasonable relation to the waiting time or delay, provided they are available on the bus or in the terminal, or can reasonably be supplied; (b) a hotel room or other accommodation as well as assistance to arrange transport between the terminal and the place of accommodation in cases where a stay of 1 or more nights becomes necessary. For each passenger, the carrier may limit the total cost of accommodation, not including transport to and from the terminal and place of accommodation, to EUR 80 per night and for a maximum of 2 nights. In applying this Article the carrier shall pay particular attention to the needs of disabled persons and persons with reduced mobility and any accompanying persons. Article 22 Further claims Nothing in this Chapter shall preclude passengers from seeking damages in accordance with national law before national courts in respect of loss resulting from cancellation or delay of regular services. Article 23 Exemptions 1. Articles 19 and 21 shall not apply to passengers with open tickets as long as the time of departure is not specified, except for passengers holding a travel pass or a season ticket. 2. Point (b) of Article 21 shall not apply where the carrier proves that the cancellation or delay is caused by severe weather conditions or major natural disasters endangering the safe operation of bus or coach services. CHAPTER V GENERAL RULES ON INFORMATION AND COMPLAINTS Article 24 Right to travel information Carriers and terminal managing bodies shall, within their respective areas of competence, provide passengers with adequate information throughout their travel. Where feasible, this information shall be provided in accessible formats upon request. Article 25 Information on passenger rights 1. Carriers and terminal managing bodies shall, within their respective areas of competence, ensure that passengers are provided with appropriate and comprehensible information regarding their rights under this Regulation at the latest on departure. This information shall be provided at terminals and where applicable, on the Internet. At the request of a disabled person or person with reduced mobility the information shall be provided, where feasible, in an accessible format. This information shall include contact details of the enforcement body or bodies designated by the Member State pursuant to Article 28(1). 2. In order to comply with the information requirement referred to in paragraph 1, carriers and terminal managing bodies may use a summary of the provisions of this Regulation prepared by the Commission in all the official languages of the institutions of the European Union and made available to them. Article 26 Complaints Carriers shall set up or have in place a complaint handling mechanism for the rights and obligations set out in this Regulation. Article 27 Submission of complaints Without prejudice to claims for compensation in accordance with Article 7, if a passenger covered by this Regulation wants to make a complaint to the carrier, he shall submit it within 3 months from the date on which the regular service was performed or when a regular service should have been performed. Within 1 month of receiving the complaint, the carrier shall give notice to the passenger that his complaint has been substantiated, rejected or is still being considered. The time taken to provide the final reply shall not be longer than 3 months from the receipt of the complaint. CHAPTER VI ENFORCEMENT AND NATIONAL ENFORCEMENT BODIES Article 28 National enforcement bodies 1. Each Member State shall designate a new or existing body or bodies responsible for the enforcement of this Regulation as regards regular services from points situated on its territory and regular services from a third country to such points. Each body shall take the measures necessary to ensure compliance with this Regulation. Each body shall, in its organisation, funding decisions, legal structure and decision making, be independent of carriers, tour operators and terminal managing bodies. 2. Member States shall inform the Commission of the body or bodies designated in accordance with this Article. 3. Any passenger may submit a complaint, in accordance with national law, to the appropriate body designated under paragraph 1, or to any other appropriate body designated by a Member State, about an alleged infringement of this Regulation. A Member State may decide that the passenger as a first step shall submit a complaint to the carrier in which case the national enforcement body or any other appropriate body designated by the Member State shall act as an appeal body for complaints not resolved under Article 27. Article 29 Report on enforcement By 1 June 2015 and every 2 years thereafter, the enforcement bodies designated pursuant to Article 28(1) shall publish a report on their activity in the previous 2 calendar years, containing in particular a description of actions taken in order to implement this Regulation and statistics on complaints and sanctions applied. Article 30 Cooperation between enforcement bodies National enforcement bodies as referred to in Article 28(1) shall, whenever appropriate, exchange information on their work and decision-making principles and practices. The Commission shall support them in this task. Article 31 Penalties Member States shall lay down rules on penalties applicable to infringements of the provisions of this Regulation and shall take all the measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify those rules and measures to the Commission by 1 March 2013 and shall notify it without delay of any subsequent amendment affecting them. CHAPTER VII FINAL PROVISIONS Article 32 Report The Commission shall report to the European Parliament and the Council by 2 March 2016 on the operation and effects of this Regulation. The report shall be accompanied, where necessary, by legislative proposals implementing in further detail the provisions of this Regulation, or amending it. Article 33 Amendment to Regulation (EC) No 2006/2004 In the Annex to Regulation (EC) No 2006/2004 the following point is added: \u201819. Regulation (EU) No 181/2011 of the European Parliament and of the Council of 16 February 2011 on the rights of passengers in bus and coach transport (12). Article 34 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 March 2013. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 February 2011. For the European Parliament The President J. BUZEK For the Council The President MARTONYI J. (1) OJ C 317, 23.12.2009, p. 99. (2) Position of the European Parliament of 23 April 2009 (OJ C 184 E, 8.7.2010, p. 312), position of the Council at first reading of 11 March 2010 (OJ C 122 E, 11.5.2010, p. 1), position of the European Parliament of 6 July 2010 (not yet published in the Official Journal), decision of the Council of 31 January 2011 and legislative resolution of the European Parliament of 15 February 2011 (not yet published in the Official Journal). (3) OJ L 263, 7.10.2009, p. 11. (4) OJ L 199, 31.7.2007, p. 40. (5) OJ L 177, 4.7.2008, p. 6. (6) OJ L 226, 10.9.2003, p. 4. (7) OJ L 158, 23.6.1990, p. 59. (8) OJ L 281, 23.11.1995, p. 31. (9) OJ L 364, 9.12.2004, p. 1. (10) OJ L 180, 19.7.2000, p. 22. (11) OJ L 373, 21.12.2004, p. 37. (12) OJ L 55, 28.2.2011, p. 1\u2019. ANNEX I ASSISTANCE PROVIDED TO DISABLED PERSONS AND PERSONS WITH REDUCED MOBILITY (a) Assistance at designated terminals Assistance and arrangements necessary to enable disabled persons and persons with reduced mobility to: \u2014 communicate their arrival at the terminal and their request for assistance at designated points, \u2014 move from the designated point to the check-in counter, waiting room and embarkation area, \u2014 board the vehicle, with the provision of lifts, wheelchairs or other assistance needed, as appropriate, \u2014 load their luggage, \u2014 retrieve their luggage, \u2014 alight from the vehicle, \u2014 carry a recognised assistance dog on board a bus or coach, \u2014 proceed to the seat; (b) Assistance on board Assistance and arrangements necessary to enable disabled persons and persons with reduced mobility to: \u2014 be provided with essential information on a journey in accessible formats subject to request made by the passenger, \u2014 board/alight during pauses in a journey, if there are personnel other than the driver on board. ANNEX II DISABILITY-RELATED TRAINING (a) Disability-awareness training Training of staff that deal directly with the travelling public includes: \u2014 awareness of and appropriate responses to passengers with physical, sensory (hearing and visual), hidden or learning disabilities, including how to distinguish between the different abilities of persons whose mobility, orientation, or communication may be reduced, \u2014 barriers faced by disabled persons and persons with reduced mobility, including attitudinal, environmental/physical and organisational barriers, \u2014 recognised assistance dogs, including the role and the needs of an assistance dog, \u2014 dealing with unexpected occurrences, \u2014 interpersonal skills and methods of communication with deaf people and people with hearing impairments, people with visual impairments, people with speech impairments, and people with a learning disability, \u2014 how to handle wheelchairs and other mobility aids carefully so as to avoid damage (if any, for all staff who are responsible for luggage handling); (b) Disability-assistance training Training of staff directly assisting disabled persons and persons with reduced mobility includes: \u2014 how to help wheelchair users make transfers into and out of a wheelchair, \u2014 skills for providing assistance to disabled persons and persons with reduced mobility travelling with a recognised assistance dog, including the role and the needs of those dogs, \u2014 techniques for escorting visually impaired passengers and for the handling and carriage of recognised assistance dogs, \u2014 an understanding of the types of equipment which can assist disabled persons and persons with reduced mobility and a knowledge of how to handle such an equipment, \u2014 the use of boarding and alighting assistance equipment used and knowledge of the appropriate boarding and alighting assistance procedures that safeguard the safety and dignity of disabled persons and persons with reduced mobility, \u2014 understanding of the need for reliable and professional assistance. Also awareness of the potential of certain disabled passengers to experience feelings of vulnerability during travel because of their dependence on the assistance provided, \u2014 a knowledge of first aid.", "summary": "Bus and coach passengers\u2019 rights Bus and coach passengers\u2019 rights Passengers, including those with a disability or reduced mobility, travelling by bus and coach enjoy the same rights wherever they travel in the European Union (EU). These rights, including the right to information or compensation in the case of delay or cancellation, complement similar rights for sea and inland waterway, air and rail passengers. ACT Regulation (EU) No 181/2011 of the European Parliament and of the Council of 16 February 2011 concerning the rights of passengers in bus and coach transport and amending Regulation (EC) No 2006/2004 SUMMARY Passengers, including those with a disability or reduced mobility, travelling by bus and coach enjoy the same rights wherever they travel in the European Union (EU). These rights, including the right to information or compensation in the case of delay or cancellation, complement similar rights for sea and inland waterway, air and rail passengers. WHAT DOES THIS REGULATION DO? The regulation sets down rules for bus and coach transport regarding regular services* for passengers travelling within the EU for distances of 250 kms or more. Some of its provisions apply to all services, including those of a shorter distance. KEY POINTS In respect of long-distance services, i.e. of more than 250 kms, the regulation provides: in situations of cancellation or following a delay of more than 90 minutes in the case of a journey of more than 3 hours, for adequate assistance e.g. snacks, meals and up to 2 nights\u2019 hotel. accommodation; guarantee of reimbursement or rerouting in situations of overbooking or cancellation or following a delay of more than 120 minutes from the estimated time of departure; compensation of 50 % of the ticket price following more than 120 minutes\u2019 delay from the estimated time of departure, cancellation of a journey and if the carrier fails to offer the passenger either rerouting or reimbursement; information when the service is cancelled or delayed in departure; protection of passengers in case of injury, loss or damage caused by road accidents and/or compensation in case of death; specific assistance free of charge for disabled persons and persons with reduced mobility both at terminals and on board and, where necessary, transport free of charge for accompanying people. Additionally, for distances of less than 250 kms, the regulation provides for: non-discrimination based on nationality with respect to prices and contract conditions for passengers; non-discriminatory treatment of disabled persons and persons with reduced mobility and financial compensation for loss or damage of their mobility equipment in case of accident; minimum rules on travel information for all passengers before and during their journey and general information about their rights in terminals and online; a complaint handling mechanism established by carriers and available to all passengers; independent national bodies in each EU country with the mandate to enforce the regulation and, where appropriate, to impose penalties. The regulation provides for the option of exemptions for domestic regular services and for regular services where a significant part is operated outside the EU. WHEN DOES THIS REGULATION APPLY? From 1 March 2013. BACKGROUND European Commission website on bus and coach passenger rights Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted:Commission Notice Interpretative Guidelines on EU passenger rights regulations in the context of the developing situation with Covid-19Commission Recommendation (EU) 2020/648 of 13 May 2020 on vouchers offered to passengers and travellers as an alternative to reimbursement for cancelled package travel and transport services in the context of the COVID-19 pandemicKEY TERMS *regular services: ordinary bus and coach services carrying passengers along specified routes with pre-determined pick-up/stopping points. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 181/2011 20.3.2011 - OJ L 55, 28.2.2011, pp. 1-12 last update 02.06.2020"}
{"article": "13.8.2008 EN Official Journal of the European Union L 218/1 REGULATION (EC) No 762/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 on the submission by Member States of statistics on aquaculture and repealing Council Regulation (EC) No 788/96 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof, Having regard to the proposal from the Commission, Acting in accordance with the procedure laid down in Article 251 of the Treaty (1), Whereas: (1) Council Regulation (EC) No 788/96 of 22 April 1996 on the submission by Member States of statistics on aquaculture production (2) requires the Member States to submit annual data on the volume of production. (2) The increased contribution by aquaculture to the Community's total fisheries production requires a wider range of data for a rational development and management of this sector within the Common Fisheries Policy. (3) The increasing importance of hatcheries and nurseries for aquaculture activity requires detailed data for a suitable monitoring and management of this sector within the Common Fisheries Policy. (4) Information on both the volume and value of the production is required to review and assess the market for aquaculture products. (5) Information on the structure of the sector and on the technologies employed is required to ensure an environmentally sound industry. (6) Regulation (EC) No 788/96 should be repealed. (7) In order to ensure a smooth transition from the regime applicable under Regulation (EC) No 788/96, this Regulation should allow for a transitional period of up to three years to be granted to Member States where its application to their national statistical systems would require major adaptations and would be likely to cause significant practical problems. (8) Since the objective of this Regulation, namely the establishment of a common legal framework for systematic production of Community statistics on the aquaculture sector, cannot be sufficiently achieved by the Member States and can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (9) Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (3) provides a reference framework for statistics in the field of fisheries. In particular, it requires conformity with principles of impartiality, reliability, relevance, cost-effectiveness, statistical confidentiality and transparency. (10) The collection and submission of statistical data is an essential tool for the sound management of the Common Fisheries Policy. (11) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4). (12) In particular, the Commission should be empowered to adopt technical changes to the Annexes to this Regulation. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (13) The Commission should be assisted by the Standing Committee for Agricultural Statistics set up by Council Decision 72/279/EEC (5), HAVE ADOPTED THIS REGULATION: Article 1 Obligations of the Member States Member States shall submit to the Commission statistics on all the aquaculture activities conducted in freshwater and saltwaters on their territory. Article 2 Definitions 1. For the purpose of this Regulation, the following definitions shall apply: (a) \u2018Community statistics\u2019 as defined in Article 2 of Regulation (EC) No 322/97; (b) \u2018aquaculture\u2019 as defined in Article 3(d) of Council Regulation (EC) No 1198/2006 of 27 July 2006 on the European Fisheries Fund (6); (c) \u2018capture-based aquaculture\u2019 means the practice of collecting specimens from the wild and their subsequent use in aquaculture; (d) \u2018production\u2019 means the output from aquaculture at first sale, including production from hatcheries and nurseries offered for sale. 2. All other definitions for the purpose of this Regulation are set out in Annex I. Article 3 Compilation of statistics 1. Member States shall use surveys or other statistically validated methods covering at least 90 % of the total production by volume, or by number for the production of hatcheries and nurseries, without prejudice to paragraph 4. The remaining part of the total production may be estimated. To estimate more than 10 % of the total production, a request for derogation may be submitted under the conditions provided for in Article 8. 2. Use of sources other than surveys shall be subject to provision of an ex-post assessment of the statistical quality of those sources. 3. A Member State having a total annual production of less than 1 000 tonnes may submit summary data estimating the total production. 4. Member States shall identify the production by species. However, the production of those species which individually do not exceed 500 tonnes and do not represent more than 5 % in weight of the production by volume in a Member State may be estimated and aggregated. The production of hatcheries and nurseries in number of those species may be estimated. Article 4 Data The data shall relate to the reference calendar year and shall cover: (a) the annual production (volume and unit value) of aquaculture; (b) the annual input (volume and unit value) to capture-based aquaculture; (c) the annual production of hatcheries and nurseries; (d) the structure of the aquaculture sector. Article 5 Submission of data 1. The Member States shall submit the data referred to in Annexes II, III and IV to the Commission (Eurostat) within 12 months of the end of the reference calendar year. The first reference calendar year shall be 2008. 2. Starting with the data for the year 2008 and at intervals of three years thereafter, the data on the structure of the aquaculture sector referred to in Annex V shall be submitted within 12 months of the end of the reference calendar year to the Commission (Eurostat). Article 6 Quality assessment 1. Each Member State shall provide the Commission (Eurostat) with a yearly report on the quality of the data submitted. 2. At the submission of the data, each Member State shall submit to the Commission a detailed methodological report. In that report, each Member State shall describe how the data were collected and compiled. This report shall include details of sampling techniques, estimation methods and of sources used other than surveys and an evaluation of the quality of the resultant estimates. A proposed format for the methodological report is indicated in Annex VI. 3. The Commission shall examine the reports and present its conclusions to the relevant working group of the Standing Committee for Agricultural Statistics set up by Decision 72/279/EEC. Article 7 Transitional period 1. Full calendar year transitional periods for implementing this Regulation lasting not more than three years from 1 January 2009 may be granted to Member States in accordance with the management procedure referred to in Article 10(2), in so far as the application of this Regulation to their national statistical systems requires major adaptations and is likely to cause significant practical problems. 2. To this end, a Member State shall present a duly motivated request to the Commission by 31 December 2008. Article 8 Derogations 1. In cases where inclusion in the statistics of a particular sector of aquaculture activities would cause difficulties to the national authorities not commensurate with the importance of that sector, a derogation may be granted in accordance with the management procedure referred to in Article 10(2). Such derogation shall permit a Member State to exclude data covering that sector from the national data submitted or to employ estimation methods used to provide data for more than 10 % of the total production. 2. Member States shall support any request for derogations, which must be made prior to the deadline for the first submission of the data, by sending the Commission a report on problems encountered in applying this Regulation. 3. Should a change in the situation for collecting the data create unforeseen difficulties for the national authorities, a duly justified request for a derogation may be submitted by the Member States after the deadline for the first submission of the data. Article 9 Technical provisions 1. The measures designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, relating to technical changes to the Annexes shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3). 2. The format in which statistics shall be submitted shall be adopted in accordance with the management procedure referred to in Article 10(2). Article 10 Committee procedure 1. The Commission shall be assisted by the Standing Committee for Agricultural Statistics. 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 11 Evaluation report By 31 December 2011 and every three years thereafter, the Commission shall submit an evaluation report to the European Parliament and to the Council on the statistics compiled pursuant to this Regulation and, in particular, on their relevance and quality. This report shall also undertake a cost-effectiveness analysis of the system introduced to collect and draw up the statistics and shall indicate best practices to lessen the workload for Member States and enhance the usefulness and quality of the data. Article 12 Repeal 1. Without prejudice to paragraph 3, Regulation (EC) No 788/96 is hereby repealed. 2. References to the repealed Regulation shall be construed as references to this Regulation. 3. By way of derogation from the second paragraph of Article 13 of this Regulation, a Member State having been granted a transitional period in accordance with Article 7 of this Regulation shall continue to apply the provisions of Regulation (EC) No 788/96 for the duration of the transitional period granted. Article 13 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 January 2009. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 July 2008. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J.-P. JOUYET (1) Opinion of the European Parliament of 31 January 2008 (not yet published in the Official Journal) and Council Decision of 23 June 2008. (2) OJ L 108, 1.5.1996, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). (3) OJ L 52, 22.2.1997, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council. (4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (5) OJ L 179, 7.8.1972, p. 1. (6) OJ L 223, 15.8.2006, p. 1. ANNEX I Definitions to be used in submission of aquaculture data 1. \u2018Freshwater\u2019 means water which has a constantly negligible salinity. 2. \u2018Saltwater\u2019 means water where the salinity is appreciable. This may be water where the salinity is constantly high (e.g. seawater) or where the salinity is appreciable but not at a constantly high level (e.g. brackish water): the salinity may be subject to periodic variation due to the influx of fresh or seawaters. 3. \u2018Species\u2019 means the species of aquatic organisms identified using the international 3-alpha code as defined by the FAO (ASFIS list of species for fishery statistics purposes). 4. \u2018FAO major areas\u2019 means the geographical areas identified using the international numerical-2 code as defined by the FAO (CWP Handbook of fishery statistical standards. Section H: Fishing areas for statistical purposes). The FAO major areas covered for the purpose of this Regulation are the following: Code Area 01 Inland waters (Africa) 05 Inland waters (Europe) 27 North-east Atlantic 34 Atlantic Eastern Central 37 Mediterranean and Black Seas \u2026 Other areas (to be specified) 5. \u2018Ponds\u2019 means relatively shallow and usually small bodies of still water or water with a low refreshment rate, most frequently artificially formed, but can also apply to natural pools, tarns, meres or small lakes. 6. \u2018Hatcheries and nurseries\u2019 means places for the artificial breeding, hatching and rearing through the early life stages of aquatic animals. For statistical purposes, hatcheries are limited to the production of fertilised eggs. First juvenile stages of aquatic animals are considered as being produced in nurseries. 7. \u2018Enclosures and pens\u2019 means areas of water confined by nets, mesh and other barriers allowing uncontrolled water interchange and distinguished by the fact that enclosures occupy the full water column between substrate and surface; pens and enclosures generally enclose a relatively large volume of water. 8. \u2018Cages\u2019 means open or covered enclosed structures constructed with net, mesh or any porous material allowing natural water interchange. These structures may be floating, suspended or fixed to the substrate but still permitting water interchange from below. 9. \u2018Tanks and raceways\u2019 means artificial units constructed above or below ground level capable of high rates of water interchange or with a high water turnover rate and highly controlled environment but without water recirculation. 10. \u2018Recirculation systems\u2019 means systems where the water is reused after some form of treatment (e.g. filtering). 11. \u2018Transferred to a controlled environment\u2019 means the intentional release for further aquaculture practices. 12. \u2018Released to the wild\u2019 means the intentional release for the restocking of rivers, lakes and other waters other than for aquaculture purposes. These releases may then be available for capture by fishing operations. 13. \u2018Volume\u2019 means: (a) for fish, crustaceans and molluscs and other aquatic animals, the live weight equivalent of the product. For molluscs, the live weight shall include the weight of the shell; (b) for aquatic plants, the wet weight of the product. 14. \u2018Unit value\u2019 means the total value (excluding invoiced value-added tax) of the production (in national currency) divided by the total volume of the production. ANNEX II Production from aquaculture excluding nurseries and hatcheries (1) Country: Year: Species produced FAO major area Freshwater Saltwater Total 3-alpha code Common name Scientific name Volume (metric tonnes) Unit value (national currency) Volume (metric tonnes) Unit value (national currency) Volume (metric tonnes) Unit value (national currency) FISH Ponds Tanks and raceways Enclosures and pens Cages Recirculation systems Other methods CRUSTACEANS Ponds Tanks and raceways Enclosures and pens Other methods MOLLUSCS On bottom Off bottom Other methods SEAWEEDS All methods Fish eggs (intended for consumption) (2) All methods OTHER AQUATIC ORGANISMS All methods (1) With the exclusion of aquarium and ornamental species. (2) The fish eggs intended for consumption considered under this item refer only to extracted eggs destined for consumption at first sale. ANNEX III Input to capture-based aquaculture (1) Country: Year: Species Unit (specify) (2) Unit value (national currency) 3-alpha code Common name Scientific name FISH CRUSTACEANS MOLLUSCS (1) With the exclusion of aquarium, ornamental and plant species. (2) Weight or number; if numbers are provided, a conversion factor to live weight must be provided as well. ANNEX IV Production of hatcheries and nurseries (1) Country: Year: Species Stage in life cycle Intended uses 3-alpha code Common name Scientific name Eggs (in millions) Juveniles (in millions) Transferred to a controlled environment (for on-growing) (2) (in millions) Released to the wild (2) (in millions) Eggs Juveniles Eggs Juveniles (1) With the exclusion of aquarium and ornamental species. (2) Voluntary. ANNEX V Data on the structure of the aquaculture sector (1) (4) Country: Year: FAO major area Freshwater Saltwater Total Size of the facilities (3) Size of the facilities (3) Size of the facilities (3) (thousand m3) Hectares (thousand m3) Hectares (thousand m3) Hectares FISH Ponds Tanks and raceways Enclosures and pens Cages Recirculation systems Other methods CRUSTACEANS Ponds Tanks and raceways Enclosures and pens Other methods MOLLUSCS On bottom (2) Off bottom (2) Other methods (2) SEAWEEDS All methods (1) With the exclusion of aquarium and ornamental species. (2) If molluscs are grown on ropes, length unit may be used. (3) Should be considered the potential capacity. (4) The shaded cells indicate where information is not applicable. ANNEX VI Format for the methodological reports of the national systems for aquaculture statistics 1. Organisation of the national system for aquaculture statistics: \u2014 authorities responsible for collecting and processing the data and their respective responsibilities, \u2014 national legislation on the collection of aquaculture data, \u2014 unit responsible for submitting data to the Commission. 2. Method of collecting, processing and compiling the aquaculture data: \u2014 indicate the source of each type of data, \u2014 describe the methods used to collect the data (e.g. postal questionnaires, personal interviews, censuses or sampling, frequency of surveys, estimation methods) for each part of the aquaculture sector, \u2014 describe how the data are processed and compiled and how long this takes. 3. Quality aspects in line with the \u2018Code of Practice for the European Statistical System\u2019: \u2014 if estimation techniques are used for some elements of the data, describe the methods used, and estimate the level of use and reliability of such methods, \u2014 indicate any shortcomings of the national systems, ways of overcoming them and, where appropriate, the timetable for such corrective actions.", "summary": "Aquaculture statistics Aquaculture statistics SUMMARY OF: Regulation (EC) No 762/2008 on the submission by EU countries of statistics on aquaculture WHAT IS THE AIM OF THIS REGULATION? It sets up a common system for the production of EU statistics on the aquaculture* sector, to help review and assess the market for aquaculture products as part of sound management of the common fisheries policy. The regulation repeals Council Regulation (EC) No 788/96. KEY POINTS EU countries must submit annual statistics on all the aquaculture carried out on their territory using surveys or other approved methods covering at least 90% of production, with the remaining part being estimated, unless an exemption is approved. If total annual production is less than 1,000 tonnes the country can submit summary data estimating the total production. Production must be identified by species, but species totalling less than 500 tonnes or 5% of total production can be estimated and aggregated. Hatchery and nursery* production of these species may be estimated. Data are submitted within 12 months of the end of the calendar year, and include: annual aquaculture production volume and value; annual input to capture-based aquaculture*; annual production of hatcheries and nurseries; structure of the aquaculture sector (every 3 years). Quality assessment Each EU country provides a yearly report on the quality of the data submitted and a detailed methodological report. The latter describes how the data were collected and compiled, including: sampling techniques, estimation methods and sources used other than surveys, as well as an evaluation of the quality of the estimates. The European Commission (Eurostat) examines the reports and presents its conclusions to the Fisheries statistics Working Group. Evaluation report Every 3 years, the European Commission submits an evaluation report to the European Parliament and to the Council on the statistics compiled, and in particular on relevance and quality. The report also includes a cost-effectiveness analysis of the statistics collection system indicating best practice to reduce workload and to enhance the usefulness and quality of the data. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 1 January 2009. BACKGROUND For more information, see: Aquaculture statistics (Eurostat). KEY TERMS Aquaculture: the farming of fish, shellfish and aquatic plants, in both inland and marine areas, using techniques designed to increase production beyond the natural capacity of the environment. Hatcheries and nurseries: places for the artificial breeding, hatching and rearing through the early life stages of aquatic animals. For statistical purposes, hatcheries are limited to the production of fertilised eggs. First juvenile stages of aquatic animals are considered as being produced in nurseries. Capture-based aquaculture: collecting specimens from the wild for use in aquaculture. MAIN DOCUMENT Regulation (EC) No 762/2008 of the European Parliament and of the Council of 9 July 2008 on the submission by Member States of statistics on aquaculture and repealing Council Regulation (EC) No 788/96 (OJ L 218, 13.8.2008, pp. 1-13) Successive amendments to Regulation (EC) No 762/2008 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) No 508/2014 of the European Parliament and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council (OJ L 149, 20.5.2014, pp. 1-66) See consolidated version. Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, pp. 164-173) See consolidated version. last update 15.05.2018"}
{"article": "31.12.2010 EN Official Journal of the European Union L 348/17 REGULATION (EU) No 1236/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries and repealing Council Regulation (EC) No 2791/1999 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Convention on future multilateral cooperation in the North-East Atlantic fisheries (the Convention), was approved by the Council in Decision 81/608/EEC (3) and entered into force on 17 March 1982. (2) The Convention provides for an appropriate framework for multilateral cooperation on the rational conservation and management of fishery resources in the Area defined by the Convention (the Convention Area). (3) The North-East Atlantic Fisheries Commission (NEAFC), at its Annual Meeting on 15 November 2006, adopted a recommendation establishing a scheme of control and enforcement (the Scheme) applicable to fishing vessels operating in the waters of the Convention Area which lie beyond the waters under the fisheries jurisdiction of the Contracting Parties (the Regulatory Area). The Scheme, which came into force on 1 May 2007, was amended by several recommendations at the Annual Meetings in November 2007, 2008 and 2009. (4) Under Articles 12 and 15 of the Convention, these recommendations came into force on 9 February 2008, 6 and 8 January 2009, and 6 February 2010 respectively. (5) The Scheme provides for control and enforcement measures applicable to vessels flying the flag of Contracting Parties and operating in the Regulatory Area, and arrangements for inspection at sea which include inspection and surveillance procedures and infringement procedures which must be implemented by the Contracting Parties. (6) The Scheme provides for a new Port State Control system which will effectively close European ports to landings and transhipments of frozen fish which have not been verified to be legal by the flag state of fishing vessels flying the flag of a Contracting Party other than the port state. (7) Certain control provisions adopted by NEAFC have been incorporated into Union law by way of the yearly TAC and quotas Regulation, and most recently by Council Regulation (EC) No 43/2009 of 16 January 2009 fixing for 2009 the fishing opportunities and associated conditions for certain fish stocks and groups of fish stocks, applicable in Community waters and, for Community vessels, in waters where catch limitations are required (4). For the sake of legal certainty, such provisions which are not of a temporary nature should be the subject of a new separate regulation. (8) The Scheme also comprises provisions to promote compliance by vessels flying the flag of a non-Contracting Party with the control and enforcement measures in order to ensure full respect of conservation and management measures adopted by NEAFC. NEAFC recommended removing a number of vessels from the list of vessels that have been confirmed to have engaged in illegal, unreported and unregulated fisheries. The incorporation of those recommendations into Union law should be ensured. (9) Article 5(2) of Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (5) provides that Member States shall control access to waters and resources and control activities outside EU waters carried out by vessels flying their flag. Provision should therefore be made for Member States whose vessels are authorised to fish in the Regulatory Area to assign inspectors to the Scheme to undertake monitoring and surveillance as well as adequate resources for inspection. (10) In order to ensure the monitoring of fishing activities in the Convention Area, it is necessary for Member States to cooperate with one another and with the Commission and the body designated by it in applying the Scheme. (11) It is the responsibility of Member States to ensure that their inspectors comply with the inspection procedures laid down by NEAFC. (12) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) in respect of detailed rules concerning lists of the fishery resources to be notified, procedures for prior notification of entry into port and for the cancellation thereof as well as authorisation to land or tranship. The Commission should also be empowered to adopt delegated acts in respect of the incorporation into Union law of future amendments of those measures of the Scheme which form the subject matter of certain expressly defined non-essential elements of this Regulation and which become binding upon the Union in accordance with the terms of the Convention. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. (13) The measures necessary for the implementation of this Regulation should be adopted by the Commission by means of implementing acts in accordance with Article 291 TFEU. According to that Article, rules and general principles concerning mechanisms for the control by Member States of the Commission\u2019s exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable. (14) As this Regulation will establish new rules concerning control and enforcement in the Convention Area, Council Regulation (EC) No 2791/1999 of 16 December 1999 laying down certain control measures applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries (7) should be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down the general rules and conditions for the application by the Union of the Scheme adopted by NEAFC. Article 2 Scope Unless otherwise stated, this Regulation shall apply to all EU vessels used or intended for use for fishing activities carried out in respect of fishery resources in the Regulatory Area. Article 3 Definitions For the purpose of this Regulation, the following definitions shall apply: 1. \u2018Convention\u2019 means the Convention on future multilateral cooperation in North-East Atlantic fisheries, as amended; 2. \u2018Convention Area\u2019 means the Convention Area as defined in Article 1(1) of the Convention; 3. \u2018Regulatory Area\u2019 means the waters of the Convention Area which lie beyond the waters under the fisheries jurisdiction of the Contracting Parties; 4. \u2018Contracting Parties\u2019 means the Contracting Parties to the Convention; 5. \u2018NEAFC\u2019 means the North-East Atlantic Fisheries Commission; 6. \u2018fishing activities\u2019 means fishing, including joint fishing operations, fish processing operations, the transhipment or landing of fish or fish products and any other commercial activity in preparation for or related to fishing; 7. \u2018fishery resources\u2019 means the resources referred to in Article 1(2) of the Convention; 8. \u2018regulated resources\u2019 means those fishery resources which are subject to recommendations under the Convention and are listed in the Annex; 9. \u2018fishing vessel\u2019 means any vessel used or intended for use for the purposes of the commercial exploitation of fishery resources, including fish processing vessels and vessels engaged in transhipment; 10. \u2018non-Contracting Party vessel\u2019 means any fishing vessel not flagged in a Contracting Party, including vessels for which there are reasonable grounds for suspecting them to be without nationality; 11. \u2018joint fishing operation\u2019 means any operations between two or more vessels where catch is taken from the fishing gear of one fishing vessel to another; 12. \u2018transhipment operation\u2019 means the unloading of all or any fishery products on board a fishing vessel onto another fishing vessel; 13. \u2018port\u2019 means any place used for landing or a place close to the shore designated by a Contracting Party for transhipping fishery resources. Article 4 Contact points 1. Member States shall designate the competent authority which shall act as the contact point for the purposes of receiving surveillance and inspection reports in accordance with Articles 12, 19, 20 and 27 and for receiving notifications and issuing authorisations in accordance with Articles 24 and 25. 2. Contact points for receiving notifications and issuing authorisations in accordance with Articles 24 and 25 shall be available 24 hours a day. 3. Member States shall send to the Commission or to the body designated by it and to the NEAFC Secretary the telephone number, e-mail address and fax number of the designated contact point. 4. Any subsequent changes to the information concerning the contact points referred to in paragraphs 1 and 3 shall be notified to the Commission or the body designated by it and to the NEAFC Secretary no later than 15 days before the change comes into force. 5. The format for transmission of the information referred to in paragraphs 1 and 3 shall be established in accordance with Article 50(2). CHAPTER II MONITORING MEASURES Article 5 Union participation 1. Member States shall send to the Commission, in a computer-readable form, a list of all vessels flying their flag and registered in the Union which are authorised to fish in the Regulatory Area, in particular the vessels authorised to fish directly for one or more regulated resources together with any amendments to the list. This information shall be sent no later than 15 December each year or no later than 5 days before the vessel enters the Regulatory Area. The Commission shall forward the information promptly to the NEAFC Secretary. 2. The format for transmission of the list referred to in paragraph 1 shall be determined in accordance with Article 50(2). Article 6 Marking of gear 1. Member States shall ensure that gear used by their fishing vessels in the Regulatory Area is marked in accordance with Commission Regulation (EC) No 356/2005 of 1 March 2005 laying down detailed rules for the marking and identification of passive fishing gear and beam trawls (8). 2. Member States may remove and dispose of fixed gear that is not marked in accordance with Regulation (EC) No 356/2005 or that contravenes in any other way recommendations adopted by NEAFC, as well as fish that are found in the gear. Article 7 Retrieval of lost gear 1. The competent authority of the flag Member State shall send without delay to the NEAFC Secretary the information provided to it pursuant to Article 48(3) of Regulation (EC) No 1224/2009 as well as the call sign of the vessel that has lost the gear. 2. Member States shall undertake to retrieve on a regular basis lost gears belonging to vessels flying their flag. Article 8 Recording of catches 1. In addition to the information specified in Article 6 of Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to the common fisheries policy (9), the masters of EU fishing vessels shall record, either in a bound paginated fishing logbook or by electronic means, the following: (a) each entry into and exit from the Regulatory Area; (b) on a daily basis and/or for each haul the estimated cumulative catches retained on board since the last entry into the Regulatory Area; (c) on a daily basis and/or for each haul the amount of fish discarded; (d) immediately after each communication pursuant to Article 9, the date and time, according to Universal Coordinated Time (UTC), of transmission of a report and, in the case of radio transmission, the name of the radio station through which the report was transmitted; (e) the fishing depth, where appropriate. 2. The masters of EU fishing vessels engaged in fishing activities carried out in respect of regulated resources and which process and/or freeze their catch shall: (a) record their cumulative production by species and product form in a production logbook; and (b) stow in the hold all processed catch in such a way that the location of each species can be identified from a stowage plan maintained on board the fishing vessel. 3. By way of derogation from paragraph 1, Member States may exempt from the obligation to record in a fishing logbook or electronically a vessel engaged in transhipment operations which on-loads quantities on board. Vessels benefiting from this derogation shall specify in a stowage plan the location in the hold of frozen fish referred to in Article 14(1) and record in a production logbook: (a) the date and time, according to UTC, of transmission of a report referred to in Article 9; (b) in the case of radio transmission, the name of the radio station through which the report was transmitted; (c) the date and time, according to UTC, of the transhipment operation; (d) the location (latitude/longitude) of the transhipment operation; (e) the quantities of each species on-loaded; (f) the name and international radio call sign of the fishing vessel from which the catch has been off-loaded. 4. Detailed rules for the implementation of this Article shall be determined in accordance with Article 50(2). Article 9 Reporting of catches of regulated resources 1. The masters of EU fishing vessels engaged in fishing activities carried out in respect of regulated resources shall communicate catch reports by electronic means to their Fisheries Monitoring Centre, as defined in point (15) of Article 4 of Regulation (EC) No 1224/2009. The data contained in such reports shall be accessible to the Commission on request. Reports shall include the following: (a) reports on the quantities held on board when entering the Regulatory Area. Such reports shall be transmitted no earlier than 12 hours and no later than 2 hours before each entry into the Regulatory Area; (b) reports on weekly catches. Such reports shall be transmitted for the first time no later than the end of the seventh day following the entry of the vessel into the Regulatory Area or, when fishing trips take more than 7 days, no later than Monday noon for catches taken in the Regulatory Area during the preceding week ending at midnight on Sunday. This report shall include the number of fishing days since the start of fishing, or since the last catch report; (c) reports on catches on board when exiting the Regulatory Area. Such reports shall be transmitted no earlier than 8 hours and no later than 2 hours before each departure from the Regulatory Area. Such reports shall include, where appropriate, the number of fishing days and the catch taken in the Regulatory Area since the start of fishing, or since the last catch report; (d) reports on the quantities on-loaded and off-loaded for each transhipment of fish during the vessel\u2019s stay in the Regulatory Area. Donor vessels shall make this report no later than 24 hours before the transhipment, and receiving vessels no later than 1 hour after the transhipment. The report shall include the date, time and geographical position of the planned transhipment as well as the total round weight by species which are to be off-loaded or which have been on-loaded in kilograms and the call signs of the donor and receiving vessels. Without prejudice to Chapter IV, at least 24 hours before any landing, the receiving vessel shall report the total catch on board, the total weight to be landed, the name of the port and the estimated date and time of landing. 2. The reports on catches referred to in this Article shall be expressed in kilograms (rounded to the nearest 100 kg). The total round weight shall be reported by species, using the FAO codes. The total quantity of species for which the total round weight by species is less than 1 tonne may be reported under the 3-alpha code MZZ (marine fish not specified). 3. Member States shall record the data contained in the catch reports in the database referred to in Article 109(1) of Regulation (EC) No 1224/2009. 4. The detailed rules for the implementation of this Article and in particular the format and the specifications for the transmissions shall be determined in accordance with Article 50(2). Article 10 Global reporting of catches and fishing effort 1. Member States shall inform the Commission by computer transmission before the 15th day of each month of the quantities of fishery resources caught in the Regulatory Area by vessels flying their flag which have been landed or transhipped during the preceding month. 2. Without prejudice to Article 33(2) of Regulation (EC) No 1224/2009, Member States shall also inform the Commission by computer transmission before the 15th day of each month of the quantities of regulated resources caught in areas under the national fisheries jurisdiction of third countries and in EU waters of the Convention Area by vessels flying their flag which have been landed or transhipped during the preceding month. 3. The format for transmission of the data pursuant to paragraphs 1 and 2 shall be determined in accordance with Article 50(2). The list of the fishery resources referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Articles 46 to 49. 4. The Commission shall compile the data referred to in paragraphs 1 and 2 for all Member States and forward them to the NEAFC Secretary within 30 days following the calendar month in which the catches were landed or transhipped. Article 11 Vessel Monitoring System Member States shall ensure the automatic and electronic transmission to the NEAFC Secretary of information obtained by the vessel monitoring system (VMS) concerning vessels flying their flag which fish or plan to fish in the Regulatory Area. The format and the specifications of these transmissions shall be determined in accordance with Article 50(2). Article 12 Communication of information 1. Member States shall communicate the reports and the information referred to in Articles 9 and 11 without delay to the NEAFC Secretary. In the event of technical malfunction, however, such reports and information shall be transmitted to the NEAFC Secretary within 24 hours of receipt. Member States shall ensure that all reports and messages forwarded by them are numbered sequentially. 2. Member States shall ensure that the reports and information transmitted to the NEAFC Secretary are in accordance with the data exchange formats and protocols determined in accordance with Article 50(2). Article 13 Transhipments and joint fishing operations 1. EU fishing vessels shall engage in transhipment activities in the Regulatory Area only if they have received prior authorisation from the competent authorities in their flag Member State. 2. EU fishing vessels may only engage in transhipment operations or joint fishing operations with vessels flying the flag of a Contracting Party and vessels of a non-Contracting Party granted the status of a cooperating non-Contracting Party by NEAFC. 3. EU fishing vessels engaged in transhipment operations which on-load quantities on board shall not engage in other fishing activities, including joint fishing operations, during the same trip, with the exception of fish-processing operations and landings. Article 14 Separate stowage 1. EU fishing vessels which carry on board frozen fishery resources caught in the Convention Area by more than one fishing vessel may stow the fish from each of those vessels in more than one part of the hold but shall keep it clearly separate from fish caught by other vessels, in particular by using plastic, plywood or netting. 2. All catches taken inside the Convention Area shall be stowed separately from all catches taken outside the area. Article 15 Labelling of frozen fish When frozen, all fish caught in the Convention Area shall be identified with a clearly legible label or stamp. The label or stamp shall be placed at the time of stowage on each box or block of frozen fish and shall indicate the species, the production date, the ICES sub-area and division where the catch was taken and the name of the vessel which caught the fish. CHAPTER III INSPECTIONS AT SEA Article 16 NEAFC inspectors 1. Member States whose fishing vessels are authorised to fish in the Regulatory Area shall assign inspectors to the Scheme to carry out surveillance and inspection (NEAFC inspectors). 2. Member States shall issue a special identity document to each NEAFC inspector. The form of this document shall be determined in accordance with Article 50(2). 3. Each NEAFC inspector shall carry and produce the special identity document when boarding a fishing vessel. Article 17 General provisions for inspection and surveillance 1. The Commission or the body designated by it shall coordinate the surveillance and inspection activities for the Union and shall draw up each year, in concert with the Member States concerned, a joint deployment plan for Union participation in the Scheme in the following year. This deployment plan shall, inter alia, determine the number of inspections to be carried out. Where at any time more than ten EU fishing vessels are engaged in fishing activities carried out in respect of regulated resources in the Regulatory Area, the Commission or the body designated by it shall ensure that an inspection vessel from a Member State is present during that time in the Regulatory Area or that an agreement has been concluded with another Contracting Party to ensure the presence of an inspection vessel. 2. Member States shall ensure that the inspections by their NEAFC inspectors are carried out in a non-discriminatory manner and in accordance with the Scheme. The number of inspections shall be based on fleet size, taking into account the time spent by fishing vessels in the Regulatory Area. 3. The Commission or the body designated by it shall seek to ensure, through an equitable distribution of inspections, equal treatment of all Contracting Parties with fishing vessels operating in the Regulatory Area. 4. Member States shall take steps to ensure that NEAFC inspectors from another Contracting Party are permitted to carry out inspections on board vessels flying their flag. 5. NEAFC inspectors shall avoid the use of force except in cases of legitimate self-defence. When carrying out inspections on board fishing vessels, NEAFC inspectors shall not carry fire-arms. This paragraph shall be without prejudice to national provisions concerning the prohibition of the use of force. 6. NEAFC inspectors shall avoid causing any inconvenience to the fishing vessel or interfering with its activities and the catch retained on board, except when and to the degree necessary to carry out their mandates. Article 18 Means to carry out inspection 1. Member States shall make available to their NEAFC inspectors adequate means to enable them to carry out their surveillance and inspection tasks. To that end they shall assign inspection vessels and aircraft to the Scheme. 2. The Commission or the body designated by it shall send to the NEAFC Secretary before 1 January each year details of the plan together with the names of the NEAFC inspectors and special inspection vessels as well as the types of aircraft and their identification details (registration number, name, radio call-sign) which Member States are assigning to the Scheme during that year. Where appropriate, this information shall be taken from the list of inspectors referred to in Article 79(1) of Regulation (EC) No 1224/2009. Member States shall send changes to this list to the Commission or the body designated by it which in turn shall forward them to the NEAFC Secretary and the other Member States 1 month before the changes are due to come into effect. 3. Any vessel assigned to the Scheme and carrying NEAFC inspectors, as well as the boarding craft deployed by that vessel, shall display the NEAFC inspection special signal to indicate that NEAFC inspectors on board may carry out inspection duties in accordance with the Scheme. Aircraft assigned to the Scheme shall have their international radio call-sign clearly displayed. The form of the special signal shall be determined in accordance with Article 50(2). 4. For each Union inspection vessel or aircraft assigned to the Scheme, the Commission or the body designated by it shall keep a record of the date and hour of the start and termination of their duties under the Scheme as set out in the form determined in accordance with Article 50(2). Article 19 Surveillance procedure 1. Surveillance shall be based on sightings of fishing vessels by NEAFC inspectors from a vessel or aircraft assigned to the Scheme. NEAFC inspectors shall forward a copy of each sighting report for every vessel without delay, by electronic transmission in the form set out in accordance with Article 50(2), to the flag state of the vessel concerned, to the Commission or the body designated by it and to the NEAFC Secretary. A hard copy of each sighting report and any photographs shall be forwarded on request to the flag state of the vessel concerned. 2. NEAFC inspectors shall record their sightings in a surveillance report using a form established in accordance with Article 50(2). Article 20 Inspection procedure 1. NEAFC inspectors shall not board any fishing vessel without prior notice being transmitted by radio to that vessel or without that vessel being given the appropriate signal using the International Code of Signals, including the identity of the inspection platform; however, it shall not be necessary for such notice to be acknowledged as received. 2. NEAFC inspectors shall have the authority to examine all relevant areas, decks and rooms of the fishing vessels, catch (whether processed or not), nets or other gear, equipment, and any relevant documents which they deem necessary to verify compliance with the conservation and management measures adopted by NEAFC and to question the master or a person designated by the master. 3. The fishing vessel to be boarded shall not be required to stop or manoeuvre when fishing, shooting or hauling. The NEAFC inspectors may order that the hauling of the fishing gear be interrupted or delayed until they have boarded the fishing vessel but may not do so in any event more than 30 minutes after the fishing vessel has received the signal referred to in paragraph 1. 4. Masters of inspection platforms shall ensure that they manoeuvre at a safe distance from the fishing vessels in accordance with good seamanship. 5. NEAFC inspectors may instruct a fishing vessel to delay its entry into or exit from the Regulatory Area for up to 6 hours from the time of transmission by the fishing vessel of the reports referred to in Article 9(1)(a) and (c). 6. The duration of an inspection shall not exceed 4 hours, or the time it takes to haul in the net and to inspect the net and the catch, whichever is longer. Where an infringement is detected the NEAFC inspectors may stay on board for the time necessary for the completion of the measures provided for in Article 29(1)(b). 7. In special circumstances relating to the size of a fishing vessel and the quantities of fish retained on board, the duration of the inspection may exceed the limits laid down in paragraph 6. In such a situation, NEAFC inspectors shall under no circumstances stay on board the fishing vessel longer than the time required to complete the inspection. The reasons for exceeding the limit laid down in paragraph 6 shall be recorded in the inspection report referred to in paragraph 9. 8. No more than two NEAFC inspectors assigned by a Member State shall board a fishing vessel of another Contracting Party. In carrying out their inspection, the NEAFC inspectors may request the master to provide any assistance which is required. NEAFC inspectors shall not interfere with the master\u2019s ability to communicate with the authorities of the flag state during the boarding and inspection. 9. Each inspection shall be documented by the completion of an inspection report in the format established in accordance with Article 50(2). The master may add his comments to the inspection report which shall be signed by the NEAFC inspectors at the end of the inspection. A copy of the inspection report shall be given to the master of the fishing vessel. A copy of each inspection report shall be transmitted without delay to the flag state of the inspected vessel and to the Commission or the body designated by it. The Commission or the body designated by it shall forward the copy promptly to the NEAFC Secretary. The original or a certified copy of each inspection report shall be forwarded on request to the flag state of the inspected vessel. Article 21 Obligations of the master of the vessel during the inspection procedure The master of a fishing vessel shall: (a) facilitate prompt and safe boarding and disembarkation pursuant to specifications adopted in accordance with Article 50(2); (b) cooperate with and assist in the inspection of the fishing vessel conducted pursuant to this Regulation, not obstruct, intimidate or interfere with the NEAFC inspectors in the performance of their duties and ensure their safety; (c) allow the NEAFC inspectors to communicate with the authorities of the flag state and the inspecting state; (d) provide access to any areas, decks and rooms of the fishing vessel, catch (whether processed or not), nets or other gear, equipment, and to any relevant information or documents which the NEAFC inspectors deem necessary in accordance with Article 20(2); (e) provide copies of documents as required by the NEAFC inspectors; and (f) provide NEAFC inspectors with reasonable facilities, including, where appropriate, food and accommodation when they remain on board the vessel in accordance with Article 32(3). CHAPTER IV PORT STATE CONTROL OF FISHING VESSELS FLYING THE FLAG OF ANOTHER CONTRACTING PARTY Article 22 Scope Without prejudice to Regulation (EC) No 1224/2009 and to Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (10), the provisions set out in this Chapter shall apply to landing or transhipping in ports of Member States of fishery resources frozen after being caught in the Convention Area by fishing vessels flying the flag of another Contracting Party. Article 23 Designated ports Member States shall designate and notify the Commission of ports where the landing or transhipment of fishery resources frozen after being caught in the Convention Area by fishing vessels flying the flag of another Contracting Party are permitted. The Commission shall notify the NEAFC Secretary of these ports and of any changes to the list of ports designated at least 15 days before the change comes into force. Landings and transhipments of fish frozen after being caught in the Convention Area by fishing vessels flying the flag of another Contracting Party shall be allowed only in designated ports. Article 24 Prior notification of entry into port 1. In accordance with Article 6 of Regulation (EC) No 1005/2008, when the master of a fishing vessel carrying fish referred to in Article 22 of this Regulation intends to call into a port to land or tranship fish, the master of the vessel, or his representative, shall notify the competent authorities of the Member State of the port he wishes to use no later than three working days before the estimated time of arrival. However, a Member State may make provision for another notification period, taking into account, in particular, the distance between the fishing grounds and its ports. In such a case, the Member State shall inform the Commission, or the body designated by it, and the NEAFC Secretary thereof without delay. 2. Masters or their representatives may cancel a prior notification by notifying the competent authorities of the port they wish to use no later than 24 hours before the notified estimated time of arrival in that port. The notification shall be accompanied by a copy of the original notification form with the word \u2018CANCELLED\u2019 written across it. However, a Member State may make provision for another notification period for cancellation. In such a case, the Member State shall inform the Commission, or the body designated by it, and the NEAFC Secretary thereof without delay. 3. The competent authorities of the port Member State shall forward without delay a copy of the notifications referred to in paragraphs 1 and 2 to the flag state of the fishing vessel and to the flag state or states of the donor vessels when the fishing vessel has engaged in transhipment operations. A copy of the notification referred to in paragraph 2 shall also be forwarded without delay to the NEAFC Secretary. 4. The format and the specifications of the notifications shall be determined in accordance with Article 50(2). As far as necessary, further detailed rules on the notification and cancellation procedures under this Article, including periods, shall be adopted in accordance with the procedure laid down in Articles 46 to 49. Article 25 Authorisation to land or tranship 1. The flag state of the fishing vessel intending to land or tranship or, where the fishing vessel has engaged in transhipment operations outside EU waters, the flag state or states of the donor vessels, shall, by returning a copy of the prior notification referred to in Article 24 to the competent authorities of the port Member State, confirm that: (a) the fishing vessel which declared having caught the fish had sufficient quota for the species declared; (b) the quantities of fish on board have been duly reported and taken into account for the calculation of any catch or effort limitations that may be applicable; (c) the fishing vessel which declared having caught the fish had authorisation to fish in the areas declared; (d) the presence of the fishing vessel in the area of catch declared has been verified according to VMS data. 2. Landing or transhipment operations may only start after authorisation has been given by the competent authorities of the port Member State. Such authorisation shall only be given if the confirmation from the flag state referred to in paragraph 1 has been received. 3. By way of derogation from paragraph 2, the competent authorities of the port Member State may authorise all or part of a landing in the absence of the confirmation referred to in paragraph 1, but in such cases they shall keep the fish concerned in storage under their control. The fish shall only be released to be sold, taken over or transported once the confirmation referred to in paragraph 1 has been received. If the confirmation has not been received within 14 days of the landing the competent authorities of the port Member State may confiscate and dispose of the fish in accordance with national rules. 4. The competent authorities of the port Member State shall without delay notify their decision on whether or not to authorise the landing or transhipment to the master and shall inform the NEAFC Secretary thereof. 5. Detailed rules on the authorisation to land or tranship under this Article shall be adopted in accordance with the procedure laid down in Articles 46 to 49. Article 26 Port inspections 1. Each Member State shall carry out inspections of at least 15 % of landings or transhipments in its ports during each reporting year. 2. Inspections shall involve the monitoring of the entire discharge or transhipment and include a cross-check between the quantities by species recorded in the prior notification of landing and the quantities by species landed or transhipped. When the landing or transhipment has been completed, the inspector shall verify and note the quantities by species of fish remaining on board. 3. National inspectors shall make all possible efforts to avoid delaying a vessel unduly and to ensure that the vessel suffers the minimum interference and inconvenience and that degradation of the quality of the fish is avoided. 4. The port Member State may invite inspectors of other Contracting Parties to accompany their own inspectors and observe the inspection of landings or transhipment operations of fishery resources caught by fishing vessels flying the flag of another Contracting Party. Article 27 Inspection reports 1. Each inspection shall be documented by the completion of an inspection report using the form established in accordance with Article 50(2). 2. The master may add his comments to the inspection report, which shall be signed by the inspector and the master at the end of the inspection. A copy of the inspection report shall be given to the master of the fishing vessel. 3. A copy of each inspection report shall be transmitted without delay to the flag state of the inspected fishing vessel, to the flag state or states of the donor vessels where the vessel has engaged in transhipment operations, to the Commission or the body designated by it and to the NEAFC Secretary. The original or a certified copy of each inspection report shall be forwarded on request to the flag state of the inspected vessel. CHAPTER V INFRINGEMENTS Article 28 Scope Without prejudice to Regulation (EC) No 1224/2009 and to Regulation (EC) No 1005/2008 the provisions set out in this Chapter shall apply to EU fishing vessels and to fishing vessels flying the flag of another Contracting Party used or intended for use for fishing activities carried out in respect of fishery resources in the Regulatory Area. Article 29 Infringement procedures 1. Where inspectors find that there are clear grounds for believing that a fishing vessel has engaged in any activity contrary to the conservation and management measures adopted by NEAFC they shall: (a) record the infringement in the report referred to in Articles 19(2), 20(9) or 27; (b) take all necessary measures to ensure security and continuity of the evidence. An identification mark may be affixed securely to any part of the fishing gear which appears to the inspector to be or to have been in contravention of applicable measures; (c) attempt immediately to communicate with an inspector or designated authority of the flag state of the inspected fishing vessel; (d) transmit the inspection report promptly to the Commission or the body designated by it. 2. The Member State carrying out the inspection shall communicate in writing the details of the infringement to the designated authority of the flag state of the inspected vessel and to the Commission or the body designated by it and, whenever possible, shall do so during the first working day following the start of the inspection. 3. The Member State carrying out the inspection shall send without delay the original of the surveillance or inspection report with any supporting documents to the competent authorities of the flag state of the inspected fishing vessel as well as a copy to the Commission or the body designated by it, which shall forward a copy to the NEAFC Secretary. Article 30 Follow-up in the case of infringement 1. Where a Member State is notified by another Contracting Party or another Member State of an infringement committed by a fishing vessel flying its flag, it shall take prompt action in conformity with its national law to obtain and consider the evidence of the infringement and to conduct any further investigation necessary for the follow-up to the infringement and, whenever possible, to inspect the fishing vessel concerned. 2. Member States shall designate the competent authorities which are to receive evidence of infringement and shall inform the Commission or the body designated by it of the address of those authorities and of any change in this information. The Commission or the body designated by it shall subsequently forward the information to the NEAFC Secretary. Article 31 Serious infringements For the purpose of this Regulation, the following infringements shall be considered to be serious: (a) fishing without a valid authorisation issued by the flag state; (b) fishing without quota or after its exhaustion; (c) use of prohibited fishing gear; (d) serious misrecording of catches; (e) repeated failure to comply with Articles 9 or 11; (f) landing or transhipping in a port not designated in accordance with Article 23; (g) failure to comply with Article 24; (h) landing or transhipment without authorisation of the port state as referred to in Article 25; (i) preventing an inspector from carrying out his duties; (j) directed fishing for a stock which is subject to a moratorium or for which fishing is prohibited; (k) falsifying or concealing the markings, identity or registration of a fishing vessel; (l) concealing, tampering with or disposing of evidence relating to an investigation; (m) multiple violations which together constitute a serious disregard of conservation and management measures; (n) engaging in transhipment or joint fishing operations with vessels of a non-Contracting Party which has not been accorded the status of a cooperating non-Contracting Party by NEAFC; (o) supplying any provisions, fuel or other services to vessels that have been placed on the list referred to in Article 44. Article 32 Follow-up in the case of serious infringements 1. If an inspector considers that there are clear grounds for believing that a fishing vessel has committed a serious infringement under Article 31, that inspector shall promptly notify that infringement to the Commission or the body designated by it, the competent authorities of the flag state of the inspected fishing vessel and the flag state or states of the donor vessels where the inspected vessel has engaged in transhipment operations, in accordance with Article 29(3), and shall also transmit a copy to the NEAFC Secretary. 2. In order to preserve the evidence, the inspector shall take all necessary measures to ensure the security and continuity thereof whilst minimising inconvenience to the vessel and interference with its operation. 3. The inspector shall be entitled to remain on board the fishing vessel for the period necessary to provide information on the infringement to the duly authorised inspector referred to in Article 33, or until receiving a reply from the flag state requesting him to leave the fishing vessel. Article 33 Follow-up in the case of serious infringements by an EU fishing vessel 1. Flag Member States shall respond to the notification referred to in Article 32(1) without delay and shall ensure that the fishing vessel concerned is inspected within 72 hours by an inspector duly authorised in relation to the infringement. The duly authorised inspector shall board the fishing vessel concerned and examine the evidence of the suspected infringement established by the inspector, and forward the results of the examination as quickly as possible to the competent authority in the flag Member State and to the Commission or the body designated by it. 2. Following notification of the results of the examination referred to in paragraph 1, flag Member States shall, if the evidence so warrants, require the fishing vessel to proceed immediately, and in any case within 24 hours, to a port designated by that flag Member State, for a thorough inspection under its authority. 3. The flag Member State may authorise the inspecting state to bring without delay the fishing vessel to a port designated by the flag Member State. 4. If the fishing vessel is not called to port, the flag Member State must provide due justification in a timely manner to the Commission or the body designated by it and to the inspecting state. The Commission or the body designated by it shall forward such justification to the NEAFC Secretary. 5. Where a fishing vessel is required to proceed to port for a thorough inspection pursuant to paragraphs 2 or 3, a NEAFC inspector from another Contracting Party may, subject to the consent of the flag Member State of the fishing vessel, board and remain on board the fishing vessel as it proceeds to port, and may be present during the inspection of the fishing vessel in port. 6. Flag Member States shall inform promptly the Commission or the body designated by it of the outcome of the thorough inspection and of the measures that they have adopted as a result of the infringement. 7. The detailed rules for the implementation of this Article shall be determined in accordance with Article 50(2). Article 34 Reporting and follow-up of infringements 1. By 15 February each year, Member States shall report to the Commission or the body designated by it on the status of the proceedings concerning infringements of the conservation and management measures adopted by NEAFC which were committed during the previous calendar year. The infringements shall continue to be listed in each subsequent report until the proceedings are concluded in accordance with the relevant provisions of national law. The Commission or the body designated by it shall forward the reports to the NEAFC Secretary before 1 March of the same year. 2. The report referred to in paragraph 1 shall indicate the current status of the proceedings and in particular whether the case is pending, under appeal or still under investigation. The report shall describe in specific terms any sanctions imposed, stating in particular the level of fines, the value of forfeited fish and/or gear and any written warnings given and, if no action has been taken, it shall state the reasons thereof. Article 35 Treatment of inspection reports Without prejudice to Article 77 of Regulation (EC) No 1224/2009, Member States shall collaborate with each other and with other Contracting Parties in order to facilitate judicial or other proceedings arising from a report submitted by an inspector under the Scheme, subject to the rules governing the admissibility of evidence in domestic judicial or other systems. Article 36 Reports on surveillance and inspection activities 1. Each Member State shall report to the Commission or the body designated by it by 15 February each year for the previous calendar year: (a) the number of inspections it has carried out under Articles 19, 20 and 26, specifying the number of inspections on the vessels of each Contracting Party and, where an infringement has been committed, the date and position of the inspection of the individual vessel concerned and the nature of the infringement; (b) the number of hours flown and the number of days at sea on NEAFC patrols, the number of sightings of both Contracting Party vessels and non-Contracting Party vessels, and the list of individual vessels for which a surveillance report has been completed. 2. The Commission or the body designated by it shall compile a Union report on the basis of the reports of the Member States. It shall send the Union report to the NEAFC Secretary by 1 March each year. CHAPTER VI MEASURES TO PROMOTE COMPLIANCE BY NON-CONTRACTING PARTY FISHING VESSELS Article 37 Scope 1. This Chapter shall apply to non-Contracting Parties\u2019 fishing vessels used or intended for use for fishing activities carried out in respect of fishery resources in the Convention Area. 2. This Chapter shall be without prejudice to Regulation (EC) No 1224/2009 and to Regulation (EC) No 1005/2008. Article 38 Sightings and identifications of non-Contracting Party vessels 1. Member States shall transmit without delay to the Commission or the body designated by it any information regarding non-Contracting Party vessels sighted or otherwise identified as engaging in fishing activities in the Convention Area. The Commission or the body designated by it shall inform promptly the NEAFC Secretary and all other Member States of each sighting report it receives. 2. The Member State which sighted the non-Contracting Party vessel shall attempt to inform that vessel without delay that it has been sighted or otherwise identified as engaging in fishing activities in the Convention Area and is consequently presumed, unless its flag state has been accorded the status of cooperating non-Contracting Party by NEAFC, to be undermining the NEAFC conservation and management measures. 3. In the case of a non-Contracting Party vessel sighted or otherwise identified as engaging in transhipment activities, the presumption of undermining the NEAFC conservation and management measures shall apply to any other non-Contracting Party vessel that has been identified as having engaged in such activities with that vessel. Article 39 Inspections at sea 1. NEAFC inspectors shall request permission to board and inspect non-Contracting Party vessels sighted or otherwise identified by a Contracting Party as engaging in fishing activities in the Convention Area. If the master consents to the boarding and inspection of the vessel, the inspection shall be documented by the completion of an inspection report, as referred to Article 20(9). 2. NEAFC inspectors shall without delay transmit a copy of the inspection report to the Commission or the body designated by it, to the NEAFC Secretary and to the master of the non-Contracting Party vessel. Where the evidence in that report so warrants, a Member State may take such action as may be appropriate in accordance with international law. Member States are encouraged to examine whether their national measures are appropriate for the exercise of jurisdiction over such vessels. 3. If the master does not consent to the boarding and inspection of his vessel or does not fulfil any one of the obligations laid down in Article 21(a) to (d), the vessel shall be presumed to have engaged in illegal, unreported and unregulated fishing activities (IUU activities). The NEAFC Inspector shall inform without delay the Commission or the body designated by it thereof. In turn the Commission or the body designated by it shall promptly inform the NEAFC Secretary thereof. Article 40 Entry into port 1. The master of a non-Contracting Party fishing vessel may only call into a port designated in accordance with Article 23. The master intending to call into a port of a Member State shall notify the competent authorities of the port Member State in accordance with the provisions of Article 24. The port Member State concerned shall forward this information without delay to the flag state of the vessel and to the Commission or the body designated by it. In turn, the Commission or the body designated by it shall forward this information to the NEAFC Secretary. 2. The port Member State shall prohibit the entry into its ports of vessels that have not given the required prior notification of entry into port as referred to in Article 24. Article 41 Inspections in port 1. Member States shall ensure that all non-Contracting Party vessels entering one of their ports are inspected. The vessel shall not be allowed to land or tranship any fish until this inspection has been completed. Each inspection shall be documented by the completion of an inspection report as provided for in Article 27. Where the master of the vessel has failed to fulfil any one of the obligations laid down in Article 21(a) to (d), the vessel shall be presumed to have engaged in IUU activities. 2. Information on the results of all inspections of non-Contracting Party vessels conducted in the ports of Member States, and concerning subsequent action, shall immediately be transmitted to the Commission or the body designated by it, which shall forward such information to the NEAFC Secretary. Article 42 Landings and transhipments 1. Landings and transhipments may only start after authorisation has been given by the competent authorities of the port state. 2. Landings and transhipments from a non-Contracting Party vessel which has been inspected pursuant to Article 41 shall be prohibited in the ports and waters of all Member States if such an inspection reveals that the vessel has species on board which are subject to recommendations established under the Convention, unless the master of the vessel provides satisfactory evidence to the competent authorities proving that the fish were caught outside the Regulatory Area or in compliance with all relevant recommendations established under the Convention. 3. The vessel shall not be authorised to engage in landings or transhipments if the flag state of the vessel, or the flag state or states of the donor vessels, where the vessel has engaged in transhipment operations, does not provide the confirmation referred to in Article 25. 4. Furthermore, landings and transhipments shall be prohibited where the master of the vessel has failed to fulfil any one of the obligations laid down in Article 21(a) to (d). Article 43 Reports on non-Contracting Parties activities 1. Each Member State shall report to the Commission or the body designated by it by 15 February each year for the previous calendar year: (a) the number of inspections of non-Contracting Party vessels that it conducted under this Scheme at sea or in its ports, the names of the vessels inspected and their respective flag states, the dates of the inspections and the names of any ports where the inspections were conducted, and the results of such inspections; and (b) where fish are landed or transhipped following an inspection pursuant to this Scheme, the evidence provided pursuant to Article 42. 2. In addition to surveillance reports and information on inspections, Member States may at any time submit to the Commission or the body designated by it any further information which might be relevant for the identification of non-Contracting Party vessels that might be carrying out IUU activities in the Convention Area. 3. On the basis of this information, the Commission or the body designated by it shall send a global report on non-Contracting Parties\u2019 activities to the NEAFC Secretary by 1 March each year. Article 44 Vessels engaged in IUU activities 1. Member States shall ensure that vessels appearing in the provisional list of vessels engaged in IUU activities established by NEAFC (\u2018A\u2019 list) are: (a) inspected in accordance with the provisions of Article 41 when they enter their ports; (b) not authorised to land or tranship in their ports or in the waters under their jurisdiction; (c) not given assistance by fishing vessels, support vessels, refuel vessels, the mother-ship and cargo vessels flying their flag or permitted to participate in any transhipment or joint fishing operation with such vessels; (d) not supplied with provisions, fuel or other services. 2. The provisions laid down in paragraph 1(b) and (d) shall not be applied to any vessel appearing on the \u2018A\u2019 list where a recommendation has been made to NEAFC that the vessel in question should be removed from the \u2018A\u2019 list. CHAPTER VII FINAL PROVISIONS Article 45 Confidentiality 1. In addition to the obligations laid down in Articles 112 and 113 of Regulation (EC) No 1224/2009, Member States shall ensure confidential treatment of electronic reports and messages transmitted to and received from the NEAFC Secretary pursuant to Articles 11, 12 and 19(1). 2. The detailed rules for the implementation of this Article shall be determined in accordance with Article 50(2). Article 46 Delegation of powers 1. The Commission may adopt, by means of delegated acts in accordance with Article 47 and subject to the conditions of Articles 48 and 49 the detailed rules for the application of Article 25, as well as the list of fishery resources referred to in Article 10(1) and detailed rules on the notification and cancellation procedures, including periods, as referred to in the second subparagraph of Article 24(4). 2. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 47 Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for a period of 3 years from 1 January 2011. The Commission shall make a report in respect of the delegated powers at the latest 6 months before the end of the three-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 48. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 48 and 49. Article 48 Revocation of the delegation 1. The delegation of power referred to in Article 46 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 49 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by 2 months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act. Article 50 Implementation 1. The Commission shall be assisted by a Management Committee for Fisheries and Aquaculture. 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply. The period referred to in Article 4(3) of Decision 1999/468/EC shall be set at 3 months. Article 51 Procedure for amendments As far as is necessary, in order to incorporate into Union law amendments to the existing provisions of the Scheme which become obligatory for the Union, the Commission may amend the provisions of this Regulation by means of delegated acts in accordance with Article 47 and subject to the conditions set out in Articles 48 and 49, concerning: (a) participation of Contracting Parties in the fishery in the Regulatory area as referred to in Article 5; (b) removal and disposal of fixed gear and the retrieval of lost gear as referred to in Articles 6 and 7; (c) use of VMS as referred to in Article 11; (d) cooperation and communication of information to the NEAFC Secretary as referred to in Article 12; (e) requirements for separate stowage and labelling of frozen fishery resources as referred to in Articles 14 and 15; (f) assignment of NEAFC inspectors as referred to in Article 16; (g) measures to promote compliance with the Scheme by non-Contracting Party fishing vessels under Chapter VI; (h) the list of regulated resources set out in the Annex. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 52 Repeal Regulation (EC) No 2791/1999 is hereby repealed. Article 53 Entry into force This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 December 2010. For the European Parliament The President J. BUZEK For the Council The President O. CHASTEL (1) Opinion of 17 March 2010 (not yet published in the Official Journal). (2) Position of the European Parliament of 19 October 2010 (not yet published in the Official Journal) and decision of the Council of 29 November 2010. (3) OJ L 227, 12.8.1981, p. 21. (4) OJ L 22, 26.1.2009, p. 1. (5) OJ L 343, 22.12.2009, p. 1. (6) OJ L 184, 17.7.1999, p. 23. (7) OJ L 337, 30.12.1999, p. 1. (8) OJ L 56, 2.3.2005, p. 8. (9) OJ L 261, 20.10.1993, p. 1. (10) OJ L 286, 29.10.2008, p. 1. ANNEX REGULATED RESOURCES A) Pelagic and oceanic species Stock (common name) FAO code Scientific Name ICES subareas and divisions Redfish REB Sebastes mentella I, II, V, XII, XIV Norwegian Spring Spawning Herring (Atlanto Scandian) HER Clupea harengus I, II Blue whiting WHB Micromesistius poutassou IIa, IVa, Vb, VI, VII, XII, XIV Mackerel MAC Scomber scombrus IIa, IV, V, VI, VII, XII Haddock HAD Melanogrammus aeglefinus VIb B) Deep-Sea Species Stock (common name) FAO code Scientific Name ICES subareas Baird\u2019s smoothhead ALC Alepocehalus bairdii I to XIV Risso\u2019s smoothhead PHO Alepocephalus rostratus I to XIV Blue antimora (Blue hake) ANT Antimora rostrata I to XIV Black scabbardfish BSF Aphanopus carbo I to XIV Iceland catshark API Apristurus spp. I to XIV Greater silver smelt ARG Argentina silus I to XIV Alfonsinos ALF Beryx spp. I to XIV Tusk USK Brosme brosme I to XIV Gulper shark GUP Centrophorus granulosus I to XIV Leafscale gulper shark GUQ Centrophorus squamosus I to XIV Black dogfish CFB Centroscyllium fabricii I to XIV Portuguese dogfish CYO Centroscymnus coelolepis I to XIV Longnose velvet dogfish CYP Centroscymnus crepidater I to XIV Deep-water red crab KEF Chaceon (Geryon) affinis I to XIV Rabbit fish (Rattail) CMO Chimaera monstrosa I to XIV Frilled shark HXC Chlamydoselachus anguineus I to XIV Conger eel COE Conger conger I to XIV Roundnose grenadier RNG Coryphaenoides rupestris I to XIV Kitefin shark SCK Dalatias licha I to XIV Birdbeak dogfish DCA Deania calceus I to XIV Black (Deep-water) cardinal fish EPI Epigonus telescopus I to XIV Greater lanternshark SHL Etmopterus princeps I to XIV Velvet belly SHL Etmopterus spinax I to XIV Blackmouth dogfish SHO Galeus melastomus I to XIV Mouse catshark GAM Galeus murinus I to XIV Bluemouth (Blue mouth redfish) BRF Helicolenus dactylopterus I to XIV Bluntnose six-gilled shark SBL Hexanchus griseus I to XIV Orange roughy ORY Hoplostethus atlanticus I to XIV Silver roughy (Pink) HPR Hoplostethus mediterraneus I to XIV Large-eyed rabbit fish (Ratfish) CYH Hydrolagus mirabilis I to XIV Silver scabbard fish (Cutlass fish) SFS Lepidopus caudatus I to XIV Eelpout ELP Lycodes esmarkii I to XIV Roughhead grenadier (Rough rattail) RHG Macrourus berglax I to XIV Blue ling BLI Molva dypterygia I to XIV Ling LIN Molva molva I to XIV Common mora RIB Mora moro I to XIV Sailfin roughshark (Sharpback shark) OXN Oxynotus paradoxus I to XIV Red (blackspot) seabream SBR Pagellus bogaraveo I to XIV Forkbeards GFB Phycis spp. I to XIV Wreckfish WRF Polyprion americanus I to XIV Round skate RJY Raja fyllae I to XIV Arctic skate RJG Raja hyperborea I to XIV Norwegian skate JAD Raja nidarosiensis I to XIV Greenland halibut GHL Rheinhardtius hippoglossoides I to XIV Straightnose rabbitfish RCT Rhinochimaera atlantica I to XIV Knifetooth dogfish SYR Scymnodon ringens I to XIV Small redfish (Norway haddock) SFV Sebastes viviparus I to XIV Greenland shark GSK Somniosus microcephalus I to XIV Spiny (Deep-sea) Scorpionfish TJX Trachyscorpia cristulata I to XIV Appendix Statements on Article 51 \u2018The European Parliament, the Council and the Commission note that any of the provisions of a non-essential character of the basic legislative act, which now are listed under Article 51 of the Regulation (delegation of powers), can become at any time in the future a significant element of the existing NEAFC control scheme from a political point of view, in which case the European Parliament, the Council and the Commission recall that either of the legislators, the Council or the European Parliament, can immediately exercise either the right to object to a draft Commission delegated act or the right to revoke the delegated powers as provided under Article 48 and Article 49 of the Regulation respectively.\u2019 \u2018The Council and the Parliament agree that the inclusion of any provision of the NEAFC control scheme into this Regulation as a non-essential element, now listed under Article 51, does not imply per se that such provisions will automatically be considered by the legislators to be of a non-essential character in any future Regulations.\u2019 \u2018The European Parliament, the Council and the Commission declare that the provisions of this Regulation shall be without prejudice to any future position of the institutions as regards the implementation of Article 290 TFEU or individual legislative acts containing such provisions.\u2019", "summary": "Future international cooperation in north-east Atlantic fisheries Future international cooperation in north-east Atlantic fisheries SUMMARY OF: Regulation (EU) No 1236/2010 control and enforcement system for the north-east Atlantic fisheries area Convention on cooperation in north-east Atlantic fisheries WHAT IS THE AIM OF THE REGULATION? It aims to promote international cooperation on the conservation, control and good management of the fisheries in the north-east Atlantic area. It enacts the Convention on Multilateral Cooperation in North-East Atlantic Fisheries which sets out rules for cooperation on the conservation and management of fisheries. In particular, the regulation implements the NEAFC Scheme of Control and Enforcement, which provides for control and enforcement measures for vessels flying the flag of its contracting parties; arrangements for inspections at sea; surveillance; and infringement procedures. KEY POINTS The scheme creates a new port state control system which will effectively close European ports to landings and transhipments* of frozen fish which have not been verified to be legal. EU countries must: designate a competent authority which acts as the contact point to receive surveillance and inspection reports, available 24 hours a day; send the European Commission a list of all vessels flying their flag registered in the EU that are authorised to fish in the area covered by the regulation; undertake to retrieve on a regular basis lost fishing gear belonging to vessels flying their flag. Vessel masters must: log each entry and exit from the regulatory area*, the estimated cumulative catch, the amount of fish discarded, and the fishing depth; send catch reports to their Fisheries Monitoring Centre*, which can then be accessed by the Commission. Masters of vessels which process and/or freeze their catch must record the species and type of product and stow fish products in the hold in a way that allows each species to be identified from a stowage plan kept on board. When frozen, all fish must be identified with a clearly legible label or stamp. When more than 10 EU fishing vessels are engaged in fishing activities* carried out in the regulatory area, an inspection vessel will be present. Each EU country must inspect at least 5% of landings or transhipments of fresh fish and at least 7.5% of frozen fish in its ports during each reporting year. When inspectors find that a fishing vessel has engaged in activity contrary to NEAFC conservation and management measures, they shall record and report the infringement. Serious infringements include: fishing without authorisation; fishing without quota; using prohibited fishing gear; misrecording catches; falsifying the marking or identity of vessels; preventing an inspector from carrying out their duties. EU countries\u2019 inspectors must also report any unauthorised vessels they record to the Commission. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2011. BACKGROUND The north-east Atlantic is one of the most abundant fishing areas in the world. The Convention on Multilateral Cooperation in North East Atlantic Fisheries entered into force in November 1982. The contracting parties to the Convention are the EU, the Faroe Islands, Greenland, Iceland, Norway and the Russian Federation, and the area covered stretches from the southern tip of Greenland, east to the Barents Sea and south to Portugal. In 2006, the North-East Atlantic Fisheries Commission (NEAFC) adopted a recommendation establishing a scheme of control and enforcement on fishing vessels operating in the area covered by the Convention. It also included rules for vessels flying the flag of a non-contracting party to ensure full respect of conservation and management measures adopted by the NEAFC. The NEAFC has recommended removing a number of vessels that have been engaged in illegal, unreported and unregulated fisheries. Similar rules are in force in EU waters under the common fisheries policy. KEY TERMS Transhipment: the transfer of a catch from one fishing boat to another which then incorporates it into a larger batch for shipment. Regulatory area: the waters covered by the convention which lie beyond the jurisdiction of the contracting parties. See map. Fisheries Monitoring Centre: an operational centre based in an EU country which can receive, process and transmit fisheries data. Fishing activities: fishing, fish processing operations, the transhipment or landing of fish or fish products, and any other commercial activity in preparation for or related to fishing, including packaging, transporting, refuelling or resupplying. MAIN DOCUMENTS Regulation (EU) No 1236/2010 of the European Parliament and of the Council of 15 December 2010 laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries and repealing Council Regulation (EC) No 2791/1999 (OJ L 348, 31.12.2010, pp. 17-33) Successive amendments to Regulation (EU) No 1236/2010 have been incorporated into the original document. This consolidated version is of documentary value only. Convention on future multilateral cooperation in North- East Atlantic fisheries (OJ L 227, 12.8.1981, pp. 22-35) RELATED DOCUMENTS Council Regulation (EU) No 2018/120 of 23 January 2018 fixing for 2018 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2017/127 (OJ L 27, 31.1.2018, pp. 1-168) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on External Dimension of the Common Fisheries Policy (COM(2011) 424 final, 13.7.2011) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1-50) See consolidated version. Council Decision 81/608/EEC of 13 July 1981 concerning the conclusion of the Convention on Future Multilateral Cooperation in the North-East Atlantic Fisheries (OJ L 227, 12.8.1981, p. 21) last update 13.03.2018"}
{"article": "30.1.2010 EN Official Journal of the European Union L 27/1 REGULATION (EC) No 66/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2009 on the EU Ecolabel (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) The aim of Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme (4) was to establish a voluntary ecolabel award scheme intended to promote products with a reduced environmental impact during their entire life cycle and to provide consumers with accurate, non-deceptive, science-based information on the environmental impact of products. (2) The experience gained during the implementation of Regulation (EC) No 1980/2000 has shown the need to amend that ecolabel scheme in order to increase its effectiveness and streamline its operation. (3) The amended scheme (hereinafter \u2018the EU Ecolabel scheme\u2019) should be implemented in compliance with the provisions of the Treaties, including, in particular, the precautionary principle as laid down in Article 174(2) of the EC Treaty. (4) It is necessary to ensure coordination between the EU Ecolabel scheme and the establishment of the requirements in the context of Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy related products (5). (5) The EU Ecolabel scheme is part of the sustainable consumption and production policy of the Community, which aims at reducing the negative impact of consumption and production on the environment, health, climate and natural resources. The scheme is intended to promote those products which have a high level of environmental performance through the use of the EU Ecolabel. To this effect, it is appropriate to require that the criteria with which products must comply in order to bear the EU Ecolabel be based on the best environmental performance achieved by products on the Community market. Those criteria should be simple to understand and to use and should be based on scientific evidence, taking into consideration the latest technological developments. Those criteria should be market oriented and limited to the most significant environmental impacts of products during their whole life cycle. (6) In order to avoid the proliferation of environmental labelling schemes and to encourage higher environmental performance in all sectors for which environmental impact is a factor in consumer choice, the possibility of using the EU Ecolabel should be extended. However, for food and feed product groups, a study should be undertaken to ensure that criteria are feasible and that added value can be guaranteed. For food and feed products, as well as unprocessed agricultural products that lie within the scope of Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products (6), the option that only those products certified as organic would be eligible for award of the EU Ecolabel should be considered, to avoid confusion for consumers. (7) The EU Ecolabel should aim at substituting hazardous substances by safer substances, wherever technically possible. (8) For the acceptance by the general public of the EU Ecolabel scheme, it is essential that environmental non-governmental organisations (NGOs) and consumer organisations play an important role and be actively involved in the development and setting of EU Ecolabel criteria. (9) It is desirable that any interested party may lead the development or revision of EU Ecolabel criteria provided that common procedural rules are followed and that the process is coordinated by the Commission. In order to ensure the overall coherence of the Community's action, it is also appropriate to require that the latest strategic objectives of the Community in the field of the environment, such as Environment Action Programmes, Sustainable Development Strategies and Climate Change Programmes, be taken into account in the development or revision of EU Ecolabel criteria. (10) In order to simplify the EU Ecolabel scheme and to reduce the administrative burden associated with the use of the EU Ecolabel, the assessment and verification procedures should be streamlined. (11) It is appropriate to provide for the conditions under which the EU Ecolabel may be used and, in order to ensure compliance with those conditions, to require competent bodies to undertake verifications and to prohibit the use of the EU Ecolabel where the conditions for use have not been complied with. It is also appropriate to require Member States to lay down the rules on penalties applicable to infringements of this Regulation and to ensure that they are implemented. (12) In order to increase the use of the EU Ecolabel and in order to encourage those whose products meet the EU Ecolabel criteria, the costs of using the EU Ecolabel should be reduced. (13) It is necessary to inform the public and to raise public awareness of the EU Ecolabel through promotion actions, information and education campaigns, at local, national and Community levels, in order to make consumers aware of the meaning of the EU Ecolabel and to enable them to make informed choices. It is also necessary in order to make the scheme more attractive to producers and retailers. (14) Member States should consider guidelines when they establish their national Green Public Procurement Action Plans and could consider the setting of targets for public purchasing of environmental friendly products. (15) In order to facilitate the marketing of products bearing environmental labels at national and Community levels, to limit additional work for companies, in particular SMEs, and to avoid confusing consumers, it is also necessary to enhance the coherence and promote harmonisation between the EU Ecolabel scheme and national ecolabelling schemes in the Community. (16) In order to ensure a harmonised application of the awarding system and of the market surveillance and control of the use of the EU Ecolabel throughout the Community, competent bodies should exchange information and experiences. (17) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7). (18) In particular, the Commission should be empowered to adopt the criteria with which products must comply in order to bear the EU Ecolabel and to amend the Annexes to this Regulation. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (19) For reasons of clarity and legal certainty, Regulation (EC) No 1980/2000 should therefore be replaced by this Regulation. (20) Appropriate transitional provisions should be provided to ensure a smooth transition between Regulation (EC) No 1980/2000 and this Regulation, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation lays down rules for the establishment and application of the voluntary EU Ecolabel scheme. Article 2 Scope 1. This Regulation shall apply to any goods or services which are supplied for distribution, consumption or use on the Community market whether in return for payment or free of charge (hereinafter \u2018products\u2019). 2. This Regulation shall apply neither to medicinal products for human use, as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (8), or for veterinary use, as defined in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (9), nor to any type of medical device. Article 3 Definitions For the purposes of this Regulation, the following definitions shall apply: 1. \u2018product group\u2019 means a set of products that serve similar purposes and are similar in terms of use, or have similar functional properties, and are similar in terms of consumer perception; 2. \u2018operator\u2019 means any producer, manufacturer, importer, service provider, wholesaler or retailer; 3. \u2018environmental impact\u2019 means any change to the environment resulting wholly or partially from a product during its life cycle; 4. \u2018environmental performance\u2019 means the result of a manufacturer's management of those characteristics of a product that cause environmental impact; 5. \u2018verification\u2019 means a procedure to certify that a product complies with specified EU Ecolabel criteria. Article 4 Competent bodies 1. Each Member State shall designate the body or bodies, within government ministries or outside, responsible for carrying out the tasks provided for in this Regulation (\u2018the competent body\u2019 or \u2018the competent bodies\u2019) and ensure that they are operational. Where more than one competent body is designated, the Member State shall determine those bodies\u2019 respective powers and the coordination requirements applicable to them. 2. The composition of the competent bodies shall be such as to guarantee their independence and neutrality and their rules of procedure shall be such as to ensure transparency in the conduct of their activities as well as the involvement of all interested parties. 3. Member States shall ensure that competent bodies meet the requirements laid down in Annex V. 4. Competent bodies shall ensure that the verification process is carried out in a consistent, neutral and reliable manner by a party independent from the operator being verified, based on international, European or national standards and procedures concerning bodies operating product-certification schemes. Article 5 European Union Ecolabelling Board 1. The Commission shall establish a European Union Ecolabelling Board (EUEB) consisting of the representatives of the competent bodies of all the Member States, as referred to in Article 4, and of other interested parties. The EUEB shall elect its president according to its rules of procedure. It shall contribute to the development and revision of EU Ecolabel criteria and to any review of the implementation of the EU Ecolabel scheme. It shall also provide the Commission with advice and assistance in these areas and, in particular, issue recommendations on minimum environmental performance requirements. 2. The Commission shall ensure that, in the conduct of its activities, the EUEB observes a balanced participation of all relevant interested parties in respect of each product group, such as competent bodies, producers, manufacturers, importers, service providers, wholesalers, retailers, notably SMEs, and environmental protection groups and consumer organisations. Article 6 General requirements for EU Ecolabel criteria 1. EU Ecolabel criteria shall be based on the environmental performance of products, taking into account the latest strategic objectives of the Community in the field of the environment. 2. EU Ecolabel criteria shall set out the environmental requirements that a product must fulfil in order to bear the EU Ecolabel. 3. EU Ecolabel criteria shall be determined on a scientific basis considering the whole life cycle of products. In determining such criteria, the following shall be considered: (a) the most significant environmental impacts, in particular the impact on climate change, the impact on nature and biodiversity, energy and resource consumption, generation of waste, emissions to all environmental media, pollution through physical effects and use and release of hazardous substances; (b) the substitution of hazardous substances by safer substances, as such or via the use of alternative materials or designs, wherever it is technically feasible; (c) the potential to reduce environmental impacts due to durability and reusability of products; (d) the net environmental balance between the environmental benefits and burdens, including health and safety aspects, at the various life stages of the products; (e) where appropriate, social and ethical aspects, e.g. by making reference to related international conventions and agreements such as relevant ILO standards and codes of conduct; (f) criteria established for other environmental labels, particularly officially recognised, nationally or regionally, EN ISO 14024 type I environmental labels, where they exist for that product group so as to enhance synergies; (g) as far as possible the principle of reducing animal testing. 4. EU Ecolabel criteria shall include requirements intended to ensure that the products bearing the EU Ecolabel function adequately in accordance with their intended use. 5. Before developing EU Ecolabel criteria for food and feed products, as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (10), the Commission shall undertake a study, by 31 December 2011 at the latest, exploring the feasibility of establishing reliable criteria covering environmental performance during the whole life cycle of such products, including the products of fishing and aquaculture. The study should pay particular attention to the impact of any EU Ecolabel criteria on food and feed products, as well as unprocessed agricultural products that lie within the scope of Regulation (EC) No 834/2007. The study should consider the option that only those products certified as organic would be eligible for award of the EU Ecolabel, to avoid confusion for consumers. The Commission shall decide, taking into account the outcome of the study and the opinion of the EUEB, for which group of food and feed, if any, the development of EU Ecolabel criteria is feasible, in accordance with the regulatory procedure with scrutiny referred to in Article 16(2). 6. The EU Ecolabel may not be awarded to goods containing substances or preparations/mixtures meeting the criteria for classification as toxic, hazardous to the environment, carcinogenic, mutagenic or toxic for reproduction (CMR), in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (11), nor to goods containing substances referred to in Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (12). 7. For specific categories of goods containing substances referred to in paragraph 6, and only in the event that it is not technically feasible to substitute them as such, or via the use of alternative materials or designs, or in the case of products which have a significantly higher overall environment performance compared with other goods of the same category, the Commission may adopt measures to grant derogations from paragraph 6. No derogation shall be given concerning substances that meet the criteria of Article 57 of Regulation (EC) No 1907/2006 and that are identified according to the procedure described in Article 59(1) of that Regulation, present in mixtures, in an article or in any homogeneous part of a complex article in concentrations higher than 0,1 % (weight by weight). Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 16(2). Article 7 Development and revision of EU Ecolabel criteria 1. Following consultation of the EUEB, the Commission, Member States, competent bodies and other stakeholders may initiate and lead the development or revision of EU Ecolabel criteria. Where such other stakeholders are put in charge of leading the development of criteria, they must demonstrate expertise in the product area, as well as the ability to lead the process with neutrality and in line with the aims of this Regulation. In this regard, consortiums consisting of more than one interest group shall be favoured. The party which initiates and leads the development or revision of EU Ecolabel criteria shall, in accordance with the procedure set out in Part A of Annex I, produce the following documents: (a) a preliminary report; (b) a proposal for draft criteria; (c) a technical report in support of the proposal for draft criteria; (d) a final report; (e) a manual for potential users of the EU Ecolabel and competent bodies; (f) a manual for authorities awarding public contracts. Those documents shall be submitted to the Commission and to the EUEB. 2. Where criteria have already been developed under another ecolabel scheme complying with the requirements of EN ISO 14024 type I environmental labels for a product group for which no EU Ecolabel criteria have been established, any Member State in which the other ecolabel scheme is recognised may, after consulting the Commission and the EUEB, propose those criteria for development under the EU Ecolabel scheme. In such cases, the shortened criteria development procedure laid down in Part B of Annex I may apply provided that the proposed criteria have been developed in line with Part A of Annex I. Either the Commission or the Member State which, according to the first subparagraph, has proposed the shortened criteria development procedure shall lead that procedure. 3. Where a non-substantial revision of the criteria is necessary, the shortened revision procedure laid down in Part C of Annex I may apply. 4. By 19 February 2011, the EUEB and the Commission shall agree on a working plan including a strategy and a non-exhaustive list of product groups. This plan will consider other Community action (e.g. in the field of green public procurement) and may be updated according to the latest strategic objectives of the Community in the field of the environment. This plan shall be regularly updated. Article 8 Establishment of EU Ecolabel criteria 1. Draft EU Ecolabel criteria shall be developed in accordance with the procedure laid down in Annex I and taking into account the working plan. 2. The Commission shall, no later than nine months after consulting the EUEB, adopt measures to establish specific EU Ecolabel criteria for each product group. These measures shall be published in the Official Journal of the European Union. In its final proposal, the Commission shall take into account the comments of the EUEB and shall clearly highlight, document and provide explanations for the reasoning behind any changes in its final proposal compared to the proposal for draft criteria following the consultation of the EUEB. Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 16(2). 3. In the measures referred to in paragraph 2 the Commission shall: (a) establish requirements for assessing the compliance of specific products with EU Ecolabel criteria (\u2018assessment requirements\u2019); (b) specify, for each product group, three key environmental characteristics that may be displayed in the optional label with text box described in Annex II; (c) specify, for each product group, the relevant period of validity of the criteria and of the assessment requirements; (d) specify the degree of product variability allowed during the period of validity referred to in point (c). 4. When establishing EU Ecolabel criteria, care shall be taken not to introduce measures whose implementation may impose disproportionate administrative and economic burdens on SMEs. Article 9 Award of the EU Ecolabel and terms and conditions of its use 1. Any operator who wishes to use the EU Ecolabel shall apply to the competent bodies referred to in Article 4 in accordance with the following rules: (a) where a product originates in a single Member State, the application shall be presented to a competent body of that Member State; (b) where a product originates in the same form in several Member States, the application may be presented to a competent body in one of those Member States; (c) where a product originates outside the Community, the application shall be presented to a competent body in any of the Member States in which the product is to be or has been placed on the market. 2. The EU Ecolabel shall have the form depicted in Annex II. The EU Ecolabel may only be used in connection with products complying with the EU Ecolabel criteria applicable to the products concerned and for which the EU Ecolabel has been awarded. 3. Applications shall specify the full contact details of the operator, as well as the product group in question and shall contain a full description of the product as well as all other information requested by the competent body. Applications shall include all relevant documentation, as specified in the relevant Commission measure establishing EU Ecolabel criteria for the product group in question. 4. The competent body to which an application is made shall charge fees according to Annex III. The use of the EU Ecolabel shall be conditional upon the fees having been paid in due time. 5. Within two months of receipt of an application, the competent body concerned shall check whether the documentation is complete and shall notify the operator. The competent body may reject the application if the operator fails to complete the documentation within six months after such notification. Provided that the documentation is complete and the competent body has verified that the product complies with the EU Ecolabel criteria and assessment requirements published according to Article 8, the competent body shall assign a registration number to the product. Operators shall meet the costs of testing and assessment of conformity with EU Ecolabel criteria. Operators may be charged for travel and accommodation costs where an on-site verification is needed outside the Member State in which the competent body is based. 6. Where EU Ecolabel criteria require production facilities to meet certain requirements, they shall be met in all facilities in which the product bearing the EU Ecolabel is manufactured. Where appropriate, the competent body shall undertake on-site verifications or assign an authorised agent for that purpose. 7. Competent bodies shall preferentially recognise tests which are accredited according to ISO 17025 and verifications performed by bodies which are accredited under the EN 45011 standard or an equivalent international standard. Competent bodies shall collaborate in order to ensure the effective and consistent implementation of the assessment and verification procedures, notably through the working group referred to in Article 13. 8. The competent body shall conclude a contract with each operator, covering the terms of use of the EU Ecolabel (including provisions for the authorisation and withdrawal of the EU Ecolabel, notably following the revision of criteria). To that end a standard contract shall be used in accordance with the template in Annex IV. 9. The operator may place the EU Ecolabel on the product only after conclusion of the contract. The operator shall also place the registration number on the product bearing the EU Ecolabel. 10. The competent body which has awarded the EU Ecolabel to a product shall notify the Commission thereof. The Commission shall establish a common register and update it regularly. That register shall be publicly available on a website dedicated to the EU Ecolabel. 11. The EU Ecolabel may be used on the products for which the EU Ecolabel has been awarded and on their associated promotional material. 12. The award of the EU Ecolabel shall be without prejudice to environmental or other regulatory requirements of Community or national law applicable to the various life stages of the product. 13. The right to use the EU Ecolabel shall not extend to the use of the EU Ecolabel as a component of a trademark. Article 10 Market surveillance and control of the use of the EU Ecolabel 1. Any false or misleading advertising or use of any label or logo which leads to confusion with the EU Ecolabel shall be prohibited. 2. The competent body shall, in respect of products to which it has awarded the EU Ecolabel, verify that the product complies with the EU Ecolabel criteria and assessment requirements published under Article 8, on a regular basis. The competent body shall, as appropriate, also undertake such verifications upon complaint. These verifications may take the form of random spot-checks. The competent body which has awarded the EU Ecolabel to the product shall inform the user of the EU Ecolabel of any complaints made concerning the product bearing the EU Ecolabel, and may request the user to reply to those complaints. The competent body may withhold the identity of the complainant from the user. 3. The user of the EU Ecolabel shall allow the competent body which has awarded the EU Ecolabel to the product to undertake all necessary investigations to monitor its on-going compliance with the product group criteria and Article 9. 4. The user of the EU Ecolabel shall, upon request by the competent body which has awarded the EU Ecolabel to the product, grant access to the premises on which the product concerned is produced. The request may be made at any reasonable time and without notice. 5. Where, after giving the user of the EU Ecolabel the opportunity to submit observations, any competent body which finds that a product bearing the EU Ecolabel does not comply with the relevant product group criteria or that the EU Ecolabel is not used in accordance with Article 9, it shall either prohibit the use of the EU Ecolabel on that product, or, in the event that the EU Ecolabel has been awarded by another competent body, it shall inform that competent body. The user of the EU Ecolabel shall not be entitled to repayment of the fees referred to in Article 9(4), either in whole or in part. The competent body shall without delay inform all other competent bodies and the Commission of that prohibition. 6. The competent body which has awarded the EU Ecolabel to the product shall not disclose, or use for any purpose unconnected with the award for use of the EU Ecolabel, information to which it has gained access in the course of assessing the compliance by a user of the EU Ecolabel with the rules on use of the EU Ecolabel set out in Article 9. It shall take all reasonable steps to secure the protection of the documents provided to it against falsification and misappropriation. Article 11 Ecolabelling schemes in the Member States 1. Where EU Ecolabel criteria for a given product group have been published, other nationally or regionally officially recognised EN ISO 14024 type I ecolabelling schemes which do not cover that product group at the time of publication may be extended to that product group only where the criteria developed under those schemes are at least as strict as the EU Ecolabel criteria. 2. In order to harmonise the criteria of European ecolabelling schemes (EN ISO 14024 type I), EU Ecolabel criteria shall also take into account existing criteria developed in officially recognised ecolabelling schemes in the Member States. Article 12 Promotion of the EU Ecolabel 1. Member States and the Commission shall, in cooperation with the EUEB, agree on a specific action plan to promote the use of the EU Ecolabel by: (a) awareness-raising actions and information and public education campaigns for consumers, producers, manufacturers, wholesalers, service providers, public purchasers, traders, retailers and the general public, (b) encouraging the uptake of the scheme, especially for SMEs, thus supporting the development of the scheme. 2. Promotion of the EU Ecolabel may be undertaken via the EU Ecolabel website providing basic information and promotional materials on the EU Ecolabel, and information on where to purchase EU Ecolabel products, in all Community languages. 3. Member States shall encourage the use of the \u2018Manual for authorities awarding public contracts\u2019, as specified in Annex I, Part A, point 5. For this purpose, Member States shall consider, for example, the setting of targets for the purchasing of products meeting the criteria specified in that Manual. Article 13 Exchange of information and experiences 1. In order to foster consistent implementation of this Regulation, competent bodies shall regularly exchange information and experiences, in particular on the application of Articles 9 and 10. 2. The Commission shall set up a working group of competent bodies for this purpose. The working group shall meet at least twice a year. Travel expenses shall be borne by the Commission. The working group shall elect its chair and adopt its rules of procedure. Article 14 Report By 19 February 2015, the Commission shall submit to the European Parliament and the Council a report on the implementation of the EU Ecolabel scheme. The report shall also identify elements for a possible review of the scheme. Article 15 Amendment of Annexes The Commission may amend the Annexes, including modifying the maximum fees provided for in Annex III taking into account the need for fees to cover the costs of running the scheme. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 16(2). Article 16 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 17 Penalties Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission without delay and shall notify it without delay of any subsequent amendment affecting them. Article 18 Repeal Regulation (EC) No 1980/2000 is hereby repealed. Article 19 Transitional provisions Regulation (EC) No 1980/2000 shall continue to apply to contracts concluded under Article 9 thereof until the date of expiry specified in those contracts, except for its provisions concerning fees. Article 9(4) of and Annex III to this Regulation shall apply to such contracts. Article 20 Entry into force This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 November 2009. For the European Parliament The President J. BUZEK For the Council The President \u00c5. TORSTENSSON (1) OJ C 120, 28.5.2009, p. 56. (2) OJ C 218, 11.9.2009, p. 50. (3) Opinion of the European Parliament of 2 April 2009 (not yet published in the Official Journal) and Council Decision of 26 October 2009. (4) OJ L 237, 21.9.2000, p. 1. (5) OJ L 285, 31.10.2009, p. 10. (6) OJ L 189, 20.7.2007, p. 1. (7) OJ L 184, 17.7.1999, p. 23. (8) OJ L 311, 28.11.2001, p. 67. (9) OJ L 311, 28.11.2001, p. 1. (10) OJ L 31, 1.2.2002, p. 1. (11) OJ L 353, 31.12.2008, p. 1. (12) OJ L 396, 30.12.2006, p. 1. ANNEX I PROCEDURE FOR THE DEVELOPMENT AND REVISION OF EU ECOLABEL CRITERIA A. Standard procedure The following documents must be drawn up: 1. Preliminary report The preliminary report must contain the following elements: \u2014 Quantitative indication of the potential environmental benefits related to the product group, including consideration of the benefits from other similar European and national or regional EN ISO 14024 type I ecolabelling schemes, \u2014 Reasoning for choice and scope of product group, \u2014 Consideration of any possible trade issues, \u2014 Analysis of other environmental labels' criteria, \u2014 Current laws and ongoing legislative initiatives related to the product group sector, \u2014 Analysis of the possibilities of substitution of hazardous substances by safer substances, as such or via the use of alternative materials or designs, wherever technically feasible, in particular with regard to substances of very high concern as referred to in Article 57 of Regulation (EC) No 1907/2006, \u2014 Intra-community market data for the sector, including volumes and turnover, \u2014 Current and future potential for market penetration of the products bearing the EU Ecolabel, \u2014 Extent and overall relevance of the environmental impacts associated with the product group, based on new or existing life cycle assessment studies. Other scientific evidence may also be used. Critical and controversial issues shall be reported in detail and evaluated, \u2014 References of data and information collected and used for issuing the report. The preliminary report shall be made available on the Commission's dedicated EU Ecolabel website for comment and reference during the development of the criteria. Where criteria are to be developed for food and feed product groups, the preliminary report must, with reference to the study undertaken according to Article 6(5), demonstrate the following: \u2014 there is a real added environmental value in developing EU Ecolabel criteria for the chosen product, \u2014 the EU Ecolabel has considered the whole life cycle of the product, and \u2014 the use of the EU Ecolabel on the chosen product will not cause confusion when compared with other food labels. 2. Proposal for draft criteria and associated technical report Following the publication of the preliminary report, a proposal for draft criteria and a technical report in support of the proposal shall be established. The draft criteria shall comply with the following requirements: \u2014 they shall be based on the best products available on the Community market in terms of environmental performance throughout the life cycle, and they shall correspond indicatively to the best 10-20 % of the products available on the Community market in terms of environmental performance at the moment of their adoption, \u2014 in order to allow for the necessary flexibility the exact percentage shall be defined on a case-by-case basis and in each case with the aim of promoting the most environmentally friendly products and ensuring that consumers are provided with sufficient choice, \u2014 they shall take into consideration the net environmental balance between the environmental benefits and burdens, including health and safety aspects; where appropriate, social and ethical aspects shall be considered, e.g. by making reference to related international conventions and agreements such as relevant ILO standards and codes of conduct, \u2014 they shall be based on the most significant environmental impacts of the product, be expressed as far as reasonably possible via technical key environmental performance indicators of the product, and be suitable for assessment according to the rules of this Regulation, \u2014 they shall be based on sound data and information which are representative as far as possible of the entire Community market, \u2014 they shall be based on life cycle data and quantitative environmental impacts, where applicable in compliance with the European Reference Life Cycle Data Systems (ELCD), \u2014 they shall take into consideration the views of all interested parties involved in the consultation process, \u2014 they shall guarantee harmonisation with existing legislation applicable to the product group when considering definitions, test methods and technical and administrative documentation, \u2014 they shall take into account relevant Community policies and work done on other related product groups. The proposal for draft criteria shall be written in a way that is easily accessible to those wishing to use them. It shall provide justification for each criterion and explain the environmental benefits related to each criterion. It shall highlight the criteria corresponding to the key environmental characteristics. The technical report shall include at least the following elements: \u2014 the scientific explanations of each requirement and criterion, \u2014 a quantitative indication of the overall environmental performance that the criteria are expected to achieve in their totality, when compared to that of the average products on the market, \u2014 an estimation of the expected environmental/economic/social impacts of the criteria as a whole, \u2014 the relevant test methods for assessment of the different criteria, \u2014 an estimation of testing costs, \u2014 for each criterion, information about all tests, reports and other documentation that shall be produced by users on request from a competent body in accordance with Article 10(3). The proposal for draft criteria and the technical report shall be made available for public consultation on the Commission's dedicated EU Ecolabel website for comment. The party leading the product group development shall distribute the proposal and the report to all interested parties. At least two open working group meetings shall be held on the draft criteria, to which all interested parties, such as competent bodies, industry (including SMEs), trade unions, retailers, importers, environmental and consumer organisations, shall be invited. The Commission shall also participate in those meetings. The proposal for draft criteria and the technical report shall be made available at least one month before the first working group meeting. Any subsequent proposal for draft criteria shall be made available at least one month before subsequent meetings. The reasoning behind any changes to the criteria in subsequent drafts shall be fully explained and documented with reference to discussions in the open working groups meetings and comments received in public consultation. Responses shall be given to all comments received during the criteria development process, indicating whether they are accepted or rejected and why. 3. Final report and draft criteria The final report shall contain the following elements: Clear responses to all comments and proposals, indicating whether they are accepted or rejected and why. European Union and non-European Union interested parties shall be treated on an equal footing. It shall also include the following elements: \u2014 a one-page summary of the level of support for the draft criteria by the competent bodies, \u2014 a summary list of all documents circulated in the course of the criteria development work, together with an indication of the date of circulation of each document and to whom each document has been circulated, and a copy of the documents in question, \u2014 a list of the interested parties involved in the work or which have been consulted or have expressed an opinion, together with their contact information, \u2014 an executive summary, \u2014 three key environmental characteristics for the product group that may be displayed in the optional label with text box described in Annex II, \u2014 a proposal for a marketing and communication strategy for the product group. Any observations received on the final report shall be taken into consideration, and information on the follow-up to the comments shall be provided on request. 4. Manual for potential users of the EU Ecolabel and competent bodies A manual shall be established in order to assist potential users of the EU Ecolabel and competent bodies in assessing the compliance of products with the criteria. 5. Manual for authorities awarding public contracts A manual providing guidance for the use of EU Ecolabel criteria to authorities awarding public contracts shall be established. The Commission will provide templates translated into all official Community languages for the manual for potential users and competent bodies and for the manual for authorities awarding public contracts. B. Shortened procedure where criteria have been developed by other EN ISO 14024 type I ecolabelling schemes A single report shall be submitted to the Commission. This report shall include a section demonstrating that the technical and consultation requirements set out in Part A have been met, along with a proposal for draft criteria, a manual for potential users of the EU Ecolabel and competent bodies, and a manual for authorities awarding public contracts. If the Commission is satisfied that the report and criteria meet the requirements set out in Part A, the report and the proposal for draft criteria shall be made available for public consultation on the Commission's dedicated EU Ecolabel website for a period of two months for comment. Responses shall be given to all comments received during the public consultation period, indicating whether each comment is accepted or rejected and why. Subject to any changes made during the public consultation period, and if no Member State requests an open working group meeting, the Commission may adopt the criteria pursuant to Article 8. Upon request from any Member State, an open working group meeting shall be held on the draft criteria, in which all interested parties, such as competent bodies, industry (including SMEs), trade unions, retailers, importers, environmental and consumer organisations, shall participate. The Commission shall also participate in that meeting. Subject to any changes made during the public consultation period or during the working group meeting, the Commission may adopt the criteria pursuant to Article 8. C. Shortened procedure for non-substantial revision of the criteria The Commission shall produce a report containing the following: \u2014 a justification explaining why there is no need for a full revision of the criteria and why a simple updating of the criteria and their stringency levels is sufficient, \u2014 a technical section updating the previous market data used for the setting of the criteria, \u2014 a proposal for draft revised criteria, \u2014 a quantitative indication of the overall environmental performance that the revised criteria are expected to achieve in their totality, when compared to that of the average products on the market, \u2014 a revised manual for potential users of the EU Ecolabel and competent bodies, and \u2014 a revised manual for authorities awarding public contracts. The report and the proposal for draft criteria shall be made available for public consultation on the Commission's dedicated EU Ecolabel website for a period of two months for comment. Responses shall be given to all comments received during the public consultation period, indicating whether each comment is accepted or rejected and why. Subject to any changes made during the public consultation period, and if no Member State requests an open working group meeting, the Commission may adopt the criteria pursuant to Article 8. Upon request from any Member State, an open working group meeting shall be held on the draft revised criteria, in which all interested parties, such as competent bodies, industry (including SMEs), trade unions, retailers, importers, environmental and consumer organisations, shall participate. The Commission shall also participate in that meeting. Subject to any changes made during the public consultation period or during the working group meeting, the Commission may adopt the criteria pursuant to Article 8. ANNEX II FORM OF THE EU ECOLABEL The EU Ecolabel shall take the following form: Label: Optional label with text box (the possibility for the operator to use this text box and the text used shall be that specified in the relevant product group criteria): The EU Ecolabel registration number shall also appear on the product. It shall take the following form: Where xxxx refers to the country of registration, yyy refers to the product group and zzzzz refers to the number given by the competent body. The label, the optional label with text box and the registration number shall be printed either in two colours (Pantone 347 green for the leaves and stem of the flower, the \u2018\u0404\u2019 symbol, the web address and the EU acronym and Pantone 279 for all other elements, text and borders), or in black on white, or in white on black. ANNEX III FEES 1. Application fee The competent body to which an application is made shall charge a fee according to the real administrative costs of processing the application. This fee shall be no lower than EUR 200 and no higher than EUR 1 200. In the case of small and medium enterprises (1) and operators in developing countries, the maximum application fee shall be no higher than EUR 600. In the case of micro-enterprises (1) the maximum application fee shall be EUR 350. The application fee shall be reduced by 20 % for applicants registered under the Community eco-management and audit scheme (EMAS) and/or certified under the standard ISO 14001. This reduction is subject to the condition that the applicant explicitly commits, in its environmental policy, to ensure full compliance of its ecolabelled products with the EU Ecolabel criteria throughout the period of validity of the contract and that this commitment is appropriately incorporated into the detailed environmental objectives. ISO 14001 certified applicants shall demonstrate annually the implementation of this commitment. EMAS registered applicants shall forward a copy of their annually verified environmental statement. 2. Annual fee The competent body may require each applicant who has been awarded an EU Ecolabel to pay an annual fee of up to EUR 1 500 for the use of the label. In the case of small and medium enterprises and operators in developing countries, the maximum annual fee shall be no higher than EUR 750. In the case of micro-enterprises the maximum annual fee shall be EUR 350. The period covered by the annual fee will begin with the date of the award of the EU Ecolabel to the applicant. (1) SMEs and micro-enterprises as defined by Commission Recommendation 2003/361/EC of 6 May 2003 (OJ L 124, 20.5.2003, p. 36). ANNEX IV STANDARD CONTRACT COVERING THE TERMS OF USE OF THE EU ECOLABEL PREAMBLE The competent body \u2026 (full title) hereinafter called \u2018the competent body\u2019, registered at \u2026 (full address), which for the purposes of the signature of this contract is represented by \u2026 (name of person responsible), \u2026 (full name of holder), in his capacity as producer, manufacturer, importer, service provider, wholesaler or retailer whose official registered address is \u2026 (full address), hereafter called \u2018the holder\u2019, represented by \u2026 (name of person responsible), have agreed the following with regard to the use of the EU Ecolabel, pursuant to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (1), hereinafter \u2018the EU Ecolabel Regulation\u2019: 1. USE OF THE EU ECOLABEL 1.1. The competent body grants the holder the right to use the EU Ecolabel for his products as described in the annexed product specifications, which conform to the relevant product group criteria in force for the period \u2026, adopted by the Commission of the European Communities on \u2026 (date), published in the Official Journal of the European Union of \u2026 (full reference), and annexed to this contract. 1.2. The EU Ecolabel shall be used only in the forms stipulated in Annex II to the EU Ecolabel Regulation. 1.3. The holder shall ensure that the product to be labelled complies throughout the duration of this contract with all the terms of use and provisions set out in Article 9 of the EU Ecolabel Regulation, at all times. No new application will be required for modifications in the characteristics of the products which do not affect compliance with the criteria. The holder shall however inform the competent body of such modifications by registered letter. The competent body may carry out appropriate verifications. 1.4. The contract may be extended to a wider range of products than those initially foreseen, subject to agreement by the competent body, and subject to the condition that they belong to the same product group and that they also comply with its criteria. The competent body may verify that these conditions are met. The Annex detailing the product specifications shall be modified accordingly. 1.5. The holder shall not advertise or make any statement or use any label or logo in a way which is false or misleading or which results in confusion with, or calls into question the integrity of, the EU Ecolabel. 1.6. The holder shall be responsible under this contract for the manner in which the EU Ecolabel is used in relation to his product, especially in the context of advertising. 1.7. The competent body, including its agents authorised for such purpose, may undertake all necessary investigations to monitor the ongoing compliance by the holder with both the product group criteria and the terms of use and provisions of this contract in accordance with the rules laid down in Article 10 of the EU Ecolabel Regulation. 2. SUSPENSION AND WITHDRAWAL 2.1. In the event that the holder becomes aware that he is failing to meet the terms of use or provisions contained in Article 1 of this contract, the holder shall notify the competent body and refrain from using the EU Ecolabel until those terms for use or provisions have been fulfilled and the competent body has been notified thereof. 2.2. Where the competent body considers that the holder has contravened any of the terms of use or provisions of this contract, the competent body shall be entitled to suspend or withdraw its authorisation to the holder to use the EU Ecolabel, and to take such measures as are necessary to prevent the holder from using it further, including such measures as are provided for in Articles 10 and 17 of the EU Ecolabel Regulation. 3. LIMITATION OF LIABILITY AND INDEMNITY 3.1. The holder shall not include the EU Ecolabel as part of any guarantee or warranty in relation to the product referred to in Article 1.1 of this contract. 3.2. The competent body, including its authorised agents, shall not be liable for any loss or damage sustained by the holder arising out of the award and/or use of the EU Ecolabel. 3.3. The competent body, including its authorised agents, shall not be liable for any loss or damage sustained by a third party and arising out of the award and/or use, including advertising, of the EU Ecolabel. 3.4. The holder shall indemnify and keep indemnified the competent body and its authorised agents against any loss, damage or liability sustained by the competent body, or its authorised agents, as a result of a breach of this contract by the holder or as a result of reliance by the competent body on information or documentation provided by the holder, including any claims by a third party. 4. FEES 4.1. The amount of application fee and annual fee shall be defined in accordance with Annex III of the EU Ecolabel Regulation. 4.2. Use of the EU Ecolabel is conditional upon all relevant fees having been paid in due time. 5. CONTRACT DURATION AND APPLICABLE LAW 5.1. Except as provided for in Article 5.2, 5.3 and 5.4, this contract shall run from the date on which it is signed until (\u2026) or until expiry of the product group criteria, whichever is sooner. 5.2. Where the holder has contravened any of the terms of use or provisions of this contract within the meaning of Article 2.2, the competent body shall be entitled to treat this as a breach of contract entitling the competent body, in addition to the provisions in Article 2.2, to terminate the contract, by registered letter to the holder, at an earlier date than that set out in Article 5.1, within (a time period to be determined by the competent body). 5.3. The holder may terminate the contract by giving the competent body three months' notice by registered letter. 5.4. If the product group criteria as stated in Article 1.1 are extended without amendments for any period, and if no written notice of termination from the competent body has been given at least three months before the expiry of the product group criteria and of this contract, the competent body shall inform the holder at least three months in advance that the contract shall be automatically renewed for as long as the product group criteria remain in force. 5.5. After the termination of this contract the holder may not use the EU Ecolabel in relation to the product specified in Article 1.1 and in the Annex to this contract, either as labelling or for advertising purposes. The EU Ecolabel may nevertheless, for a period of six months after the termination, be displayed on stock held by the holder or others and manufactured before the termination. This latter provision shall not apply if the contract has been terminated for the reasons set out in Article 5.2. 5.6. Any dispute between the competent body and the holder or any claim by one party against the other based on this contract which has not been settled by amicable agreement between the contracting parties, shall be subject to the applicable law determined in accordance with Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (2) and Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II (3)). The following Annexes shall form part of this contract: \u2014 a copy of Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel, in (the relevant Community language(s)), \u2014 product specifications, which shall at least include details of the names, and/or the manufacturer's internal reference numbers, the manufacturing sites, and the related EU Ecolabel registration number or numbers, \u2014 a copy of Commission Decision (\u2026 on product group criteria), Done at \u2026 date \u2026 \u2026 (Competent body) Designated person \u2026 \u2026 (Legally binding signature) \u2026 (Holder) Designated person \u2026 \u2026 (Legally binding signature) (1) OJ L 27, 30.1.2010, p. 1. (2) OJ L 177, 4.7.2008, p. 6. (3) OJ L 199, 31.7.2007, p. 40. ANNEX V REQUIREMENTS RELATING TO COMPETENT BODIES 1. A competent body shall be independent of the organisation or the product it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be designated as a competent body. 2. A competent body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the competent body or the use of such products for personal purposes. A competent body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgment or integrity in relation to conformity assessment activities for which they are designated. This shall in particular apply to consultancy services. Competent bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. 3. Competent bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. 4. A competent body shall be capable of carrying out all the conformity assessment tasks assigned to it by this Regulation, whether those tasks are carried out by the competent body itself or on its behalf and under its responsibility. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been designated, a competent body shall have at its disposal the necessary: (a) technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a competent body and other activities; (c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process. It shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. 5. The personnel responsible for carrying out conformity assessment activities shall have the following: (a) sound knowledge covering all the conformity assessment activities in relation to which the competent body has been designated; (b) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. 6. The impartiality of the competent bodies, of their top level management and of the assessment personnel shall be guaranteed. The remuneration of the top-level management and assessment personnel of a competent body shall not depend on the number of assessments carried out or on the results of those assessments. 7. Competent bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the working group of competent bodies referred to in Article 13 of this Regulation and apply as general guidance the administrative decisions and documents produced as a result of the work of that group.", "summary": "Ecolabel Ecolabel SUMMARY OF: Regulation (EC) No 66/2010 on the EU Ecolabel WHAT IS THE AIM OF THE REGULATION? It concerns the European Union (EU) Ecolabel which is a voluntary environmental labelling scheme. By means of transparent ecological criteria, it enables consumers to make conscious choices without compromising on the quality of the products. KEY POINTS The EU Ecolabel may be awarded to products and services which have a lower environmental impact than other products in the same group. The label criteria were devised using scientific data on the whole of a product\u2019s life cycle, from product development to disposal. The label may be awarded to all goods or services distributed, consumed or used on the EU market whether in return for payment or free of charge, on condition that the ecological criteria have been clearly established. It does not apply to medicinal products for human or veterinary use, or to medical devices. The system was introduced by Regulation (EEC) No 880/92 and amended by Regulation (EC) No 1980/2000. This Regulation (EC) No 66/2010 aims to improve the rules on the award, use and operation of the label. Award criteria The label is awarded in consideration of European environmental and ethical objectives. It also promotes the EU\u2019s transition to a circular economy, supporting both sustainable production and consumption. In particular: the impact of goods and services on climate change, nature and biodiversity, energy and resource consumption, generation of waste, pollution, emissions and the release of hazardous substances into the environment; the substitution of hazardous substances by safer substances; durability and reusability of products; ultimate impact on the environment, including on consumer health and safety; compliance with social and ethical standards, such as international labour standards; taking into account criteria established by other labels at national and regional levels; reducing animal testing. The label cannot be awarded to products containing substances classified by Regulation (EC) No 1272/2008 as toxic, hazardous to the environment, carcinogenic or mutagenic, or substances subject to the regulatory framework for the management of chemicals. Competent bodies EU countries must designate one or more bodies responsible for the labelling process at national level. Their operations shall be transparent and their activities shall be open to the involvement of all interested parties. They are specifically responsible for regularly checking that products comply with the label criteria. Their remit also includes receiving complaints, informing the public, monitoring false advertising and prohibiting products. The procedure for award and use of the label In order to be awarded the label, economic operators shall submit an application to: one or more EU countries, which will send it to the competent national body; a non-EU country, which will send it to the EU country where the product is marketed. If the product complies with the label criteria, the competent body shall conclude a contract with the operator, establishing the terms of use and withdrawal of the label. The operator may then place the label on the product. The use of the label is subject to payment of a fee when the application is made, and an annual fee. The European Commission has created a catalogue of products which have been awarded the label. The European Union Ecolabelling Board (EUEB) A 2010 Commission decision (Decision 2010/709/EU) establishes the EUEB. Its members are appointed by the Commission. It is composed of representatives from the EU countries and the European Economic Area, as well as from certain European organisations representing, for example, consumers, business and environmental concerns. The Commission consults the EUEB when developing or revising the award criteria and requirements of the label. Ecological criteria The Commission has adopted a series of decisions establishing ecological criteria for the awarding of the EU Ecolabel to different types of products; for several of these, the validity period expired by the end of December 2016. The Commission also adopted Regulation (EU) No 782/2013 replacing Annex III of Regulation (EC) No 66/2010 and amending the maximum fees allowed for financing the evaluation and processing of requests for the Ecolabel made by product manufacturers. FROM WHEN DOES THE REGULATION APPLY? It has applied since 19 February 2010. BACKGROUND For more information, see: \u2018The EU Ecolabel\u2019 on the European Commission's website. MAIN DOCUMENT Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L 27, 30.1.2010, pp. 1-19) Successive amendments to Regulation (EC) No 66/2010 have been incorporated in to the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Decision 2010/709/EU of 22 November 2010 establishing the European Union Ecolabelling Board (OJ L 308, 24.11.2010, p. 53) Commission Regulation (EU) No 782/2013 of 14 August 2013 amending Annex III to Regulation (EU) No 66/2010 of the European Parliament and of the Council on the EU Ecolabel (OJ L219, 15.8.2013, pp. 26-27) Commission Decision (EU) 2016/2003 of 14 November 2016 amending Decisions 2009/300/EC, 2011/263/EU, 2011/264/EU, 2011/382/EU, 2011/383/EU, 2012/720/EU and 2012/721/EU in order to prolong the period of validity of the ecological criteria for the award of the EU Ecolabel to certain products (OJ L 308, 16.11.2016, pp. 59\u201361) last update 31.01.2017"}
{"article": "16.6.2009 EN Official Journal of the European Union L 152/1 REGULATION (EC) No 469/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Regulation should be codified. (2) Pharmaceutical research plays a decisive role in the continuing improvement in public health. (3) Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research. (4) At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. (5) This situation leads to a lack of protection which penalises pharmaceutical research. (6) There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection. (7) A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market. (8) Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument. (9) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community. (10) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product. (11) Provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has already been extended under a specific national law, HAVE ADOPTED THIS REGULATION: Article 1 Definitions For the purposes of this Regulation, the following definitions shall apply: (a) \u2018medicinal product\u2019 means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals; (b) \u2018product\u2019 means the active ingredient or combination of active ingredients of a medicinal product; (c) \u2018basic patent\u2019 means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate; (d) \u2018certificate\u2019 means the supplementary protection certificate; (e) \u2018application for an extension of the duration\u2019 means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (5). Article 2 Scope Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (6) or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (7) may, under the terms and conditions provided for in this Regulation, be the subject of a certificate. Article 3 Conditions for obtaining a certificate A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c) the product has not already been the subject of a certificate; (d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product. Article 4 Subject matter of protection Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate. Article 5 Effects of the certificate Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. Article 6 Entitlement to the certificate The certificate shall be granted to the holder of the basic patent or his successor in title. Article 7 Application for a certificate 1. The application for a certificate shall be lodged within six months of the date on which the authorisation referred to in Article 3(b) to place the product on the market as a medicinal product was granted. 2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted. 3. The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1)(d) or Article 8(2), respectively, are fulfilled. 4. The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate. 5. Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate. Article 8 Content of the application for a certificate 1. The application for a certificate shall contain: (a) a request for the grant of a certificate, stating in particular: (i) the name and address of the applicant; (ii) if he has appointed a representative, the name and address of the representative; (iii) the number of the basic patent and the title of the invention; (iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3(b) and, if this authorisation is not the first authorisation for placing the product on the market in the Community, the number and date of that authorisation; (b) a copy of the authorisation to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 14 of Directive 2001/82/EC; (c) if the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication; (d) where the application for a certificate includes a request for an extension of the duration: (i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006; (ii) where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006. 2. Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) of this Article and a reference to the application for a certificate already filed. 3. The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted. 4. Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate. Article 9 Lodging of an application for a certificate 1. The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorisation referred to in Article 3(b) to place the product on the market was obtained, unless the Member State designates another authority for the purpose. The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned. 2. Notification of the application for a certificate shall be published by the authority referred to in paragraph 1. The notification shall contain at least the following information: (a) the name and address of the applicant; (b) the number of the basic patent; (c) the title of the invention; (d) the number and date of the authorisation to place the product on the market, referred to in Article 3(b), and the product identified in that authorisation; (e) where relevant, the number and date of the first authorisation to place the product on the market in the Community; (f) where applicable, an indication that the application includes an application for an extension of the duration. 3. Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate. Article 10 Grant of the certificate or rejection of the application for a certificate 1. Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation, the authority referred to in Article 9(1) shall grant the certificate. 2. The authority referred to in Article 9(1) shall, subject to paragraph 3, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this Regulation. 3. Where the application for a certificate does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time. 4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the authority shall reject the application. 5. Member States may provide that the authority referred to in Article 9(1) is to grant certificates without verifying that the conditions laid down in Article 3(c) and (d) are met. 6. Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration. Article 11 Publication 1. Notification of the fact that a certificate has been granted shall be published by the authority referred to in Article 9(1). The notification shall contain at least the following information: (a) the name and address of the holder of the certificate; (b) the number of the basic patent; (c) the title of the invention; (d) the number and date of the authorisation to place the product on the market referred to in Article 3(b) and the product identified in that authorisation; (e) where relevant, the number and date of the first authorisation to place the product on the market in the Community; (f) the duration of the certificate. 2. Notification of the fact that the application for a certificate has been rejected shall be published by the authority referred to in Article 9(1). The notification shall contain at least the information listed in Article 9(2). 3. Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected. Article 12 Annual fees Member States may require that the certificate be subject to the payment of annual fees. Article 13 Duration of the certificate 1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years. 2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect. 3. The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once. 4. Where a certificate is granted for a product protected by a patent which, before 2 January 1993, had its term extended or for which such extension was applied for, under national law, the term of protection to be afforded under this certificate shall be reduced by the number of years by which the term of the patent exceeds 20 years. Article 14 Expiry of the certificate The certificate shall lapse: (a) at the end of the period provided for in Article 13; (b) if the certificate holder surrenders it; (c) if the annual fee laid down in accordance with Article 12 is not paid in time; (d) if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of the appropriate authorisation or authorisations to place on the market in accordance with Directive 2001/83/EC or Directive 2001/82/EC. The authority referred to in Article 9(1) of this Regulation may decide on the lapse of the certificate either of its own motion or at the request of a third party. Article 15 Invalidity of the certificate 1. The certificate shall be invalid if: (a) it was granted contrary to the provisions of Article 3; (b) the basic patent has lapsed before its lawful term expires; (c) the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation. 2. Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent. Article 16 Revocation of an extension of the duration 1. The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No 1901/2006. 2. Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent. Article 17 Notification of lapse or invalidity 1. If the certificate lapses in accordance with point (b), (c) or (d) of Article 14, or is invalid in accordance with Article 15, notification thereof shall be published by the authority referred to in Article 9(1). 2. If the extension of the duration is revoked in accordance with Article 16, notification thereof shall be published by the authority referred to in Article 9(1). Article 18 Appeals The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 16(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents. Article 19 Procedure 1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent shall apply to the certificate, unless the national law lays down special procedural provisions for certificates. 2. Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate shall be excluded. Article 20 Additional provisions relating to the enlargement of the Community Without prejudice to the other provisions of this Regulation, the following provisions shall apply: (a) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Bulgaria, provided that the application for a certificate was lodged within six months from 1 January 2007; (b) any medicinal product protected by a valid basic patent in the Czech Republic and for which the first authorisation to place it on the market as a medicinal product was obtained: (i) in the Czech Republic after 10 November 1999 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; (ii) in the Community not earlier than six months prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; (c) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Estonia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or, in the case of those patents granted prior to 1 January 2000, within the six months provided for in the Patents Act of October 1999; (d) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Cyprus prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; notwithstanding the above, where the market authorisation was obtained before the grant of the basic patent, the application for a certificate must be lodged within six months of the date on which the patent was granted; (e) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Latvia prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004; (f) any medicinal product protected by a valid basic patent applied for after 1 February 1994 and for which the first authorisation to place it on the market as a medicinal product was obtained in Lithuania prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004; (g) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Hungary, provided that the application for a certificate was lodged within six months from 1 May 2004; (h) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Malta prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004; (i) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Poland, provided that the application for a certificate was lodged within six months starting no later than 1 May 2004; (j) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 January 2007; (k) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovenia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004, including in cases where the period provided for in Article 7(1) has expired; (l) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovakia after 1 January 2000 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or within six months of 1 July 2002 if the market authorisation was obtained before that date. Article 21 Transitional provisions 1. This Regulation shall not apply to certificates granted in accordance with the national legislation of a Member State before 2 January 1993 or to applications for a certificate filed in accordance with that legislation before 2 July 1992. With regard to Austria, Finland and Sweden, this Regulation shall not apply to certificates granted in accordance with their national legislation before 1 January 1995. 2. This Regulation shall apply to supplementary protection certificates granted in accordance with the national legislation of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Malta, Poland, Slovenia and Slovakia prior to 1 May 2004 and the national legislation of Romania prior to 1 January 2007. Article 22 Repeal Regulation (EEC) No 1768/92, as amended by the acts listed in Annex I, is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 23 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 6 May 2009. For the European Parliament The President H.-G. P\u00d6TTERING For the Council The President J. KOHOUT (1) OJ C 77, 31.3.2009, p. 42. (2) Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 6 April 2009. (3) OJ L 182, 2.7.1992, p. 1. (4) See Annex I. (5) OJ L 378, 27.12.2006, p. 1. (6) OJ L 311, 28.11.2001, p. 67. (7) OJ L 311, 28.11.2001, p. 1. ANNEX I REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS (referred to in Article 22) Council Regulation (EEC) No 1768/92 (OJ L 182, 2.7.1992, p. 1) Annex I, point XI.F.I, of the 1994 Act of Accession (OJ C 241, 29.8.1994, p. 233) Annex II, point 4.C.II, of the 2003 Act of Accession (OJ L 236, 23.9.2003, p. 342) Annex III, point 1.II, of the 2005 Act of Accession (OJ L 157, 21.6.2005, p. 56) Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ L 378, 27.12.2006, p. 1) Only Article 52 ANNEX II CORRELATION TABLE Regulation (EEC) No 1768/92 This Regulation \u2014 Recital 1 Recital 1 Recital 2 Recital 2 Recital 3 Recital 3 Recital 4 Recital 4 Recital 5 Recital 5 Recital 6 Recital 6 Recital 7 Recital 7 Recital 8 Recital 8 Recital 9 Recital 9 Recital 10 Recital 10 \u2014 Recital 11 \u2014 Recital 12 \u2014 Recital 13 Recital 11 Article 1 Article 1 Article 2 Article 2 Article 3, introductory wording Article 3, introductory wording Article 3, point (a) Article 3, point (a) Article 3, point (b), first sentence Article 3, point (b) Article 3, point (b), second sentence \u2014 Article 3, points (c) and (d) Article 3, points (c) and (d) Articles 4 to 7 Articles 4 to 7 Article 8(1) Article 8(1) Article 8(1a) Article 8(2) Article 8(1b) Article 8(3) Article 8(2) Article 8(4) Articles 9 to 12 Articles 9 to 12 Article 13(1), (2) and (3) Article 13(1), (2) and (3) Articles 14 and 15 Articles 14 and 15 Article 15a Article 16 Articles 16, 17 and 18 Articles 17, 18 and 19 Article 19 \u2014 Article 19a, introductory wording Article 20, introductory wording Article 19a, point (a), points (i) and (ii) Article 20, point (b), introductory wording, points (i) and (ii) Article 19a, point (b) Article 20, point (c) Article 19a, point (c) Article 20, point (d) Article 19a, point (d) Article 20, point (e) Article 19a, point (e) Article 20, point (f) Article 19a, point (f) Article 20, point (g) Article 19a, point (g) Article 20, point (h) Article 19a, point (h) Article 20, point (i) Article 19a, point (i) Article 20, point (k) Article 19a, point (j) Article 20, point (l) Article 19a, point (k) Article 20, point (a) Article 19a, point (l) Article 20, point (j) Article 20 Article 21 Article 21 \u2014 Article 22 Article 13(4) \u2014 Article 22 Article 23 Article 23 \u2014 Annex I \u2014 Annex II", "summary": "Supplementary protection certificates for medicines and plant protection products Supplementary protection certificates for medicines and plant protection products SUMMARY OF: Regulation (EC) No 1610/96 \u2014 supplementary protection certificate for plant protection products Regulation (EC) No 469/2009 \u2014 supplementary protection certificate for pharmaceutical products WHAT IS THE AIM OF THESE REGULATIONS? They provide additional protection for specific patented pharmaceutical and plant protection products that have been approved for sale. Amending Regulation (EU) 2019/933 introduced a manufacturing waiver to the protection given by a supplementary protection certificate (SPC)* for pharmaceutical products that allows EU-based companies to manufacture a generic or similar version of an SPC-protected medicine during the term of the certificate:either for exporting to a non-EU market; orfor stockpiling during the final 6 months of an SPC, ahead of entry into the EU market. This European Union protection is designed to even out any disparities and shortcomings in national pharmaceutical and plant protection product patent systems. KEY POINTS Any pharmaceutical or plant protection product may receive an SPC, where: it is protected by a national patent (the basic patent);it must have national or EU authorisation before it may be sold (marketing authorisation); andit does not already have a certificate. The SPC confers the same rights as those provided by the basic patent, apart from the limitations of the manufacturing waiver explained above. The SPC application must be lodged with the relevant national industrial property office: within 6 months of the marketing authorisation being granted; orwhere the marketing authorisation is granted before the basic patent is granted, within 6 months of the date on which the patent is granted. The SPC takes effect when the basic patent expires, and is valid for up to 5 years. The overall protection a patent and an SPC can provide may not be more than 15 years from the granting of the first marketing authorisation. The SPC may be extended once for 6 months for pharmaceutical products for children where a paediatric investigation plan has been prepared. The overall protection provided is then 15,5 years. FROM WHEN DO THE REGULATIONS APPLY? Regulation (EC) No 1610/96 has applied since 8 February 1997, except in those countries whose national law did not cover the patentability of plant protection products, where it has applied since 2 January 1998. Regulation (EC) No 469/2009 codifies Council Regulation (EEC) No 1768/92. It has applied since 6 July 2009. Amending Regulation (EU) 2019/933 has applied since 1 July 2019. BACKGROUND The time between applying for a patent for a new pharmaceutical or plant protection product and receiving authorisation to place it on the market reduces the effective period of patent protection. The SPC aims to offset that reduction in the effective patent protection in these fields of research to encourage innovation and prevent these industries moving away from EU countries. For more information, see: Supplementary protection certificates (European Commission). KEY TERMS Supplementary protection certificate: an intellectual property right for a specific product that acts as an extension of a patent. MAIN DOCUMENTS Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ L 198, 8.8.1996, pp. 30-35) Successive amendments to Regulation (EC) No 1610/96 have been incorporated into the basic text. This consolidated version is of documentary value only. Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (OJ L 152, 16.6.2009, pp. 1-10) See consolidated version. RELATED DOCUMENT Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (OJ L 153, 11.6.2019, pp. 1-10) last update 10.10.2019"}
{"article": "10.6.2009 EN Official Journal of the European Union L 147/5 CONVENTION on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters PREAMBLE THE HIGH CONTRACTING PARTIES TO THIS CONVENTION, DETERMINED to strengthen in their territories the legal protection of persons therein established, CONSIDERING that it is necessary for this purpose to determine the international jurisdiction of the courts, to facilitate recognition, and to introduce an expeditious procedure for securing the enforcement of judgments, authentic instruments and court settlements, AWARE of the links between them, which have been sanctioned in the economic field by the free trade agreements concluded between the European Community and certain States members of the European Free Trade Association, TAKING INTO ACCOUNT: \u2014 the Brussels Convention of 27 September 1968 on jurisdiction and the enforcement of judgments in civil and commercial matters, as amended by the Accession Conventions under the successive enlargements of the European Union, \u2014 the Lugano Convention of 16 September 1988 on jurisdiction and the enforcement of judgments in civil and commercial matters, which extends the application of the rules of the 1968 Brussels Convention to certain States members of the European Free Trade Association, \u2014 Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, which has replaced the abovementioned Brussels Convention, \u2014 the Agreement between the European Community and the Kingdom of Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, signed at Brussels on 19 October 2005, PERSUADED that the extension of the principles laid down in Regulation (EC) No 44/2001 to the Contracting Parties to this instrument will strengthen legal and economic cooperation, DESIRING to ensure as uniform an interpretation as possible of this instrument, HAVE in this spirit DECIDED to conclude this Convention, and HAVE AGREED AS FOLLOWS: TITLE I SCOPE Article 1 1. This Convention shall apply in civil and commercial matters whatever the nature of the court or tribunal. It shall not extend, in particular, to revenue, customs or administrative matters. 2. The Convention shall not apply to: (a) the status or legal capacity of natural persons, rights in property arising out of a matrimonial relationship, wills and succession; (b) bankruptcy, proceedings relating to the winding-up of insolvent companies or other legal persons, judicial arrangements, compositions and analogous proceedings; (c) social security; (d) arbitration. 3. In this Convention, the term \u2018State bound by this Convention\u2019 shall mean any State that is a Contracting Party to this Convention or a Member State of the European Community. It may also mean the European Community. TITLE II JURISDICTION SECTION 1 General provisions Article 2 1. Subject to the provisions of this Convention, persons domiciled in a State bound by this Convention shall, whatever their nationality, be sued in the courts of that State. 2. Persons who are not nationals of the State bound by this Convention in which they are domiciled shall be governed by the rules of jurisdiction applicable to nationals of that State. Article 3 1. Persons domiciled in a State bound by this Convention may be sued in the courts of another State bound by this Convention only by virtue of the rules set out in Sections 2 to 7 of this Title. 2. In particular the rules of national jurisdiction set out in Annex I shall not be applicable as against them. Article 4 1. If the defendant is not domiciled in a State bound by this Convention, the jurisdiction of the courts of each State bound by this Convention shall, subject to the provisions of Articles 22 and 23, be determined by the law of that State. 2. As against such a defendant, any person domiciled in a State bound by this Convention may, whatever his nationality, avail himself in that State of the rules of jurisdiction there in force, and in particular those specified in Annex I, in the same way as the nationals of that State. SECTION 2 Special jurisdiction Article 5 A person domiciled in a State bound by this Convention may, in another State bound by this Convention, be sued: 1. (a) in matters relating to a contract, in the courts for the place of performance of the obligation in question; (b) for the purpose of this provision and unless otherwise agreed, the place of performance of the obligation in question shall be: \u2014 in the case of the sale of goods, the place in a State bound by this Convention where, under the contract, the goods were delivered or should have been delivered; \u2014 in the case of the provision of services, the place in a State bound by this Convention where, under the contract, the services were provided or should have been provided. (c) if (b) does not apply then subparagraph (a) applies; 2. in matters relating to maintenance: (a) in the courts for the place where the maintenance creditor is domiciled or habitually resident; or (b) in the court which, according to its own law, has jurisdiction to entertain proceedings concerning the status of a person if the matter relating to maintenance is ancillary to those proceedings, unless that jurisdiction is based solely on the nationality of one of the parties; or (c) in the court which, according to its own law, has jurisdiction to entertain proceedings concerning parental responsibility, if the matter relating to maintenance is ancillary to those proceedings, unless that jurisdiction is based solely on the nationality of one of the parties; 3. in matters relating to tort, delict or quasi-delict, in the courts for the place where the harmful event occurred or may occur; 4. as regards a civil claim for damages or restitution which is based on an act giving rise to criminal proceedings, in the court seised of those proceedings, to the extent that that court has jurisdiction under its own law to entertain civil proceedings; 5. as regards a dispute arising out of the operations of a branch, agency or other establishment, in the courts for the place in which the branch, agency or other establishment is situated; 6. as settlor, trustee or beneficiary of a trust created by the operation of a statute, or by a written instrument, or created orally and evidenced in writing, in the courts of the State bound by this Convention in which the trust is domiciled; 7. as regards a dispute concerning the payment of remuneration claimed in respect of the salvage of a cargo or freight, in the court under the authority of which the cargo or freight in question: (a) has been arrested to secure such payment; or (b) could have been so arrested, but bail or other security has been given; provided that this provision shall apply only if it is claimed that the defendant has an interest in the cargo or freight or had such an interest at the time of salvage. Article 6 A person domiciled in a State bound by this Convention may also be sued: 1. where he is one of a number of defendants, in the courts for the place where any one of them is domiciled, provided the claims are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings; 2. as a third party in an action on a warranty or guarantee, or in any other third party proceedings, in the court seised of the original proceedings, unless these were instituted solely with the object of removing him from the jurisdiction of the court which would be competent in his case; 3. on a counter-claim arising from the same contract or facts on which the original claim was based, in the court in which the original claim is pending; 4. in matters relating to a contract, if the action may be combined with an action against the same defendant in matters relating to rights in rem in immovable property, in the court of the State bound by this Convention in which the property is situated. Article 7 Where by virtue of this Convention a court of a State bound by this Convention has jurisdiction in actions relating to liability from the use or operation of a ship, that court, or any other court substituted for this purpose by the internal law of that State, shall also have jurisdiction over claims for limitation of such liability. SECTION 3 Jurisdiction in matters relating to insurance Article 8 In matters relating to insurance, jurisdiction shall be determined by this Section, without prejudice to Articles 4 and 5(5). Article 9 1. An insurer domiciled in a State bound by this Convention may be sued: (a) in the courts of the State where he is domiciled; or (b) in another State bound by this Convention, in the case of actions brought by the policyholder, the insured or a beneficiary, in the courts for the place where the plaintiff is domiciled; or (c) if he is a co-insurer, in the courts of a State bound by this Convention in which proceedings are brought against the leading insurer. 2. An insurer who is not domiciled in a State bound by this Convention but has a branch, agency or other establishment in one of the States bound by this Convention shall, in disputes arising out of the operations of the branch, agency or establishment, be deemed to be domiciled in that State. Article 10 In respect of liability insurance or insurance of immovable property, the insurer may in addition be sued in the courts for the place where the harmful event occurred. The same applies if movable and immovable property are covered by the same insurance policy and both are adversely affected by the same contingency. Article 11 1. In respect of liability insurance, the insurer may also, if the law of the court permits it, be joined in proceedings which the injured party has brought against the insured. 2. Articles 8, 9 and 10 shall apply to actions brought by the injured party directly against the insurer, where such direct actions are permitted. 3. If the law governing such direct actions provides that the policyholder or the insured may be joined as a party to the action, the same court shall have jurisdiction over them. Article 12 1. Without prejudice to Article 11(3), an insurer may bring proceedings only in the courts of the State bound by this Convention in which the defendant is domiciled, irrespective of whether he is the policyholder, the insured or a beneficiary. 2. The provisions of this Section shall not affect the right to bring a counter-claim in the court in which, in accordance with this Section, the original claim is pending. Article 13 The provisions of this Section may be departed from only by an agreement: 1. which is entered into after the dispute has arisen; or 2. which allows the policyholder, the insured or a beneficiary to bring proceedings in courts other than those indicated in this Section; or 3. which is concluded between a policyholder and an insurer, both of whom are at the time of conclusion of the contract domiciled or habitually resident in the same State bound by this Convention, and which has the effect of conferring jurisdiction on the courts of that State even if the harmful event were to occur abroad, provided that such an agreement is not contrary to the law of that State; or 4. which is concluded with a policyholder who is not domiciled in a State bound by this Convention, except insofar as the insurance is compulsory or relates to immovable property in a State bound by this Convention; or 5. which relates to a contract of insurance insofar as it covers one or more of the risks set out in Article 14. Article 14 The following are the risks referred to in Article 13(5): 1. any loss of or damage to: (a) seagoing ships, installations situated offshore or on the high seas, or aircraft, arising from perils which relate to their use for commercial purposes; (b) goods in transit, other than passengers' baggage, where the transit consists of or includes carriage by such ships or aircraft; 2. any liability, other than for bodily injury to passengers or loss of or damage to their baggage: (a) arising out of the use or operation of ships, installations or aircraft as referred to in point 1(a) insofar as, in respect of the latter, the law of the State bound by this Convention in which such aircraft are registered does not prohibit agreements on jurisdiction regarding insurance of such risks; (b) for loss or damage caused by goods in transit as described in point 1(b); 3. any financial loss connected with the use or operation of ships, installations or aircraft as referred to in point 1(a), in particular loss of freight or charter-hire; 4. any risk or interest connected with any of those referred to in points 1 to 3; 5. notwithstanding points 1 to 4, all large risks. SECTION 4 Jurisdiction over consumer contracts Article 15 1. In matters relating to a contract concluded by a person, the consumer, for a purpose which can be regarded as being outside his trade or profession, jurisdiction shall be determined by this Section, without prejudice to Articles 4 and 5(5), if: (a) it is a contract for the sale of goods on instalment credit terms; or (b) it is a contract for a loan repayable by instalments, or for any other form of credit, made to finance the sale of goods; or (c) in all other cases, the contract has been concluded with a person who pursues commercial or professional activities in the State bound by this Convention of the consumer's domicile or, by any means, directs such activities to that State or to several States including that State, and the contract falls within the scope of such activities. 2. Where a consumer enters into a contract with a party who is not domiciled in the State bound by this Convention but has a branch, agency or other establishment in one of the States bound by this Convention, that party shall, in disputes arising out of the operations of the branch, agency or establishment, be deemed to be domiciled in that State. 3. This section shall not apply to a contract of transport other than a contract which, for an inclusive price, provides for a combination of travel and accommodation. Article 16 1. A consumer may bring proceedings against the other party to a contract either in the courts of the State bound by this Convention in which that party is domiciled or in the courts for the place where the consumer is domiciled. 2. Proceedings may be brought against a consumer by the other party to the contract only in the courts of the State bound by this Convention in which the consumer is domiciled. 3. This Article shall not affect the right to bring a counter-claim in the court in which, in accordance with this Section, the original claim is pending. Article 17 The provisions of this Section may be departed from only by an agreement: 1. which is entered into after the dispute has arisen; or 2. which allows the consumer to bring proceedings in courts other than those indicated in this Section; or 3. which is entered into by the consumer and the other party to the contract, both of whom are at the time of conclusion of the contract domiciled or habitually resident in the same State bound by this Convention, and which confers jurisdiction on the courts of that State, provided that such an agreement is not contrary to the law of that State. SECTION 5 Jurisdiction over individual contracts of employment Article 18 1. In matters relating to individual contracts of employment, jurisdiction shall be determined by this Section, without prejudice to Articles 4 and 5(5). 2. Where an employee enters into an individual contract of employment with an employer who is not domiciled in a State bound by this Convention but has a branch, agency or other establishment in one of the States bound by this Convention, the employer shall, in disputes arising out of the operations of the branch, agency or establishment, be deemed to be domiciled in that State. Article 19 An employer domiciled in a State bound by this Convention may be sued: 1. in the courts of the State where he is domiciled; or 2. in another State bound by this Convention: (a) in the courts for the place where the employee habitually carries out his work or in the courts for the last place where he did so; or (b) if the employee does not or did not habitually carry out his work in any one country, in the courts for the place where the business which engaged the employee is or was situated. Article 20 1. An employer may bring proceedings only in the courts of the State bound by this Convention in which the employee is domiciled. 2. The provisions of this Section shall not affect the right to bring a counter-claim in the court in which, in accordance with this Section, the original claim is pending. Article 21 The provisions of this Section may be departed from only by an agreement on jurisdiction: 1. which is entered into after the dispute has arisen; or 2. which allows the employee to bring proceedings in courts other than those indicated in this Section. SECTION 6 Exclusive jurisdiction Article 22 The following courts shall have exclusive jurisdiction, regardless of domicile: 1. in proceedings which have as their object rights in rem in immovable property or tenancies of immovable property, the courts of the State bound by this Convention in which the property is situated. However, in proceedings which have as their object tenancies of immovable property concluded for temporary private use for a maximum period of six consecutive months, the courts of the State bound by this Convention in which the defendant is domiciled shall also have jurisdiction, provided that the tenant is a natural person and that the landlord and the tenant are domiciled in the same State bound by this Convention; 2. in proceedings which have as their object the validity of the constitution, the nullity or the dissolution of companies or other legal persons or associations of natural or legal persons, or of the validity of the decisions of their organs, the courts of the State bound by this Convention in which the company, legal person or association has its seat. In order to determine that seat, the court shall apply its rules of private international law; 3. in proceedings which have as their object the validity of entries in public registers, the courts of the State bound by this Convention in which the register is kept; 4. in proceedings concerned with the registration or validity of patents, trade marks, designs, or other similar rights required to be deposited or registered, irrespective of whether the issue is raised by way of an action or as a defence, the courts of the State bound by this Convention in which the deposit or registration has been applied for, has taken place or is, under the terms of a Community instrument or an international convention, deemed to have taken place. Without prejudice to the jurisdiction of the European Patent Office under the Convention on the grant of European patents, signed at Munich on 5 October 1973, the courts of each State bound by this Convention shall have exclusive jurisdiction, regardless of domicile, in proceedings concerned with the registration or validity of any European patent granted for that State irrespective of whether the issue is raised by way of an action or as a defence; 5. in proceedings concerned with the enforcement of judgments, the courts of the State bound by this Convention in which the judgment has been or is to be enforced. SECTION 7 Prorogation of jurisdiction Article 23 1. If the parties, one or more of whom is domiciled in a State bound by this Convention, have agreed that a court or the courts of a State bound by this Convention are to have jurisdiction to settle any disputes which have arisen or which may arise in connection with a particular legal relationship, that court or those courts shall have jurisdiction. Such jurisdiction shall be exclusive unless the parties have agreed otherwise. Such an agreement conferring jurisdiction shall be either: (a) in writing or evidenced in writing; or (b) in a form which accords with practices which the parties have established between themselves; or (c) in international trade or commerce, in a form which accords with a usage of which the parties are or ought to have been aware and which in such trade or commerce is widely known to, and regularly observed by, parties to contracts of the type involved in the particular trade or commerce concerned. 2. Any communication by electronic means which provides a durable record of the agreement shall be equivalent to \u2018writing\u2019. 3. Where such an agreement is concluded by parties, none of whom is domiciled in a State bound by this Convention, the courts of other States bound by this Convention shall have no jurisdiction over their disputes unless the court or courts chosen have declined jurisdiction. 4. The court or courts of a State bound by this Convention on which a trust instrument has conferred jurisdiction shall have exclusive jurisdiction in any proceedings brought against a settlor, trustee or beneficiary, if relations between these persons or their rights or obligations under the trust are involved. 5. Agreements or provisions of a trust instrument conferring jurisdiction shall have no legal force if they are contrary to the provisions of Articles 13, 17 or 21, or if the courts whose jurisdiction they purport to exclude have exclusive jurisdiction by virtue of Article 22. Article 24 Apart from jurisdiction derived from other provisions of this Convention, a court of a State bound by this Convention before which a defendant enters an appearance shall have jurisdiction. This rule shall not apply where appearance was entered to contest the jurisdiction, or where another court has exclusive jurisdiction by virtue of Article 22. SECTION 8 Examination as to jurisdiction and admissibility Article 25 Where a court of a State bound by this Convention is seised of a claim which is principally concerned with a matter over which the courts of another State bound by this Convention have exclusive jurisdiction by virtue of Article 22, it shall declare of its own motion that it has no jurisdiction. Article 26 1. Where a defendant domiciled in one State bound by this Convention is sued in a court of another State bound by this Convention and does not enter an appearance, the court shall declare of its own motion that it has no jurisdiction unless its jurisdiction is derived from the provisions of this Convention. 2. The court shall stay the proceedings so long as it is not shown that the defendant has been able to receive the document instituting the proceedings or an equivalent document in sufficient time to enable him to arrange for his defence, or that all necessary steps have been taken to this end. 3. Instead of the provisions of paragraph 2, Article 15 of the Hague Convention of 15 November 1965 on the Service Abroad of Judicial and Extrajudicial Documents in Civil and Commercial matters shall apply if the document instituting the proceedings or an equivalent document had to be transmitted pursuant to that Convention. 4. Member States of the European Community bound by Council Regulation (EC) No 1348/2000 of 29 May 2000 or by the Agreement between the European Community and the Kingdom of Denmark on the service of judicial and extrajudicial documents in civil or commercial matters, signed at Brussels on 19 October 2005, shall apply in their mutual relations the provision in Article 19 of that Regulation if the document instituting the proceedings or an equivalent document had to be transmitted pursuant to that Regulation or that Agreement. SECTION 9 Lis pendens \u2014 related actions Article 27 1. Where proceedings involving the same cause of action and between the same parties are brought in the courts of different States bound by this Convention, any court other than the court first seised shall of its own motion stay its proceedings until such time as the jurisdiction of the court first seised is established. 2. Where the jurisdiction of the court first seised is established, any court other than the court first seised shall decline jurisdiction in favour of that court. Article 28 1. Where related actions are pending in the courts of different States bound by this Convention, any court other than the court first seised may stay its proceedings. 2. Where these actions are pending at first instance, any court other than the court first seised may also, on the application of one of the parties, decline jurisdiction if the court first seised has jurisdiction over the actions in question and its law permits the consolidation thereof. 3. For the purposes of this Article, actions are deemed to be related where they are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings. Article 29 Where actions come within the exclusive jurisdiction of several courts, any court other than the court first seised shall decline jurisdiction in favour of that court. Article 30 For the purposes of this Section, a court shall be deemed to be seised: 1. at the time when the document instituting the proceedings or an equivalent document is lodged with the court, provided that the plaintiff has not subsequently failed to take the steps he was required to take to have service effected on the defendant; or 2. if the document has to be served before being lodged with the court at the time when it is received by the authority responsible for service, provided that the plaintiff has not subsequently failed to take the steps he was required to take to have the document lodged with the court. SECTION 10 Provisional, including protective, measures Article 31 Application may be made to the courts of a State bound by this Convention for such provisional, including protective, measures as may be available under the law of that State, even if, under this Convention, the courts of another State bound by this Convention have jurisdiction as to the substance of the matter. TITLE III RECOGNITION AND ENFORCEMENT Article 32 For the purposes of this Convention, \u2018judgment\u2019 means any judgment given by a court or tribunal of a State bound by this Convention, whatever the judgment may be called, including a decree, order, decision or writ of execution, as well as the determination of costs or expenses by an officer of the court. SECTION 1 Recognition Article 33 1. A judgment given in a State bound by this Convention shall be recognised in the other States bound by this Convention without any special procedure being required. 2. Any interested party who raises the recognition of a judgment as the principal issue in a dispute may, in accordance with the procedures provided for in Sections 2 and 3 of this Title, apply for a decision that the judgment be recognised. 3. If the outcome of proceedings in a court of a State bound by this Convention depends on the determination of an incidental question of recognition that court shall have jurisdiction over that question. Article 34 A judgment shall not be recognised: 1. if such recognition is manifestly contrary to public policy in the State in which recognition is sought; 2. where it was given in default of appearance, if the defendant was not served with the document which instituted the proceedings or with an equivalent document in sufficient time and in such a way as to enable him to arrange for his defence, unless the defendant failed to commence proceedings to challenge the judgment when it was possible for him to do so; 3. if it is irreconcilable with a judgment given in a dispute between the same parties in the State in which recognition is sought; 4. if it is irreconcilable with an earlier judgment given in another State bound by this Convention or in a third State involving the same cause of action and between the same parties, provided that the earlier judgment fulfils the conditions necessary for its recognition in the State addressed. Article 35 1. Moreover, a judgment shall not be recognised if it conflicts with Sections 3, 4 or 6 of Title II, or in a case provided for in Article 68. A judgment may furthermore be refused recognition in any case provided for in Article 64(3) or 67(4). 2. In its examination of the grounds of jurisdiction referred to in the foregoing paragraph, the court or authority applied to shall be bound by the findings of fact on which the court of the State of origin based its jurisdiction. 3. Subject to the provisions of paragraph 1, the jurisdiction of the court of the State of origin may not be reviewed. The test of public policy referred to in Article 34(1) may not be applied to the rules relating to jurisdiction. Article 36 Under no circumstances may a foreign judgment be reviewed as to its substance. Article 37 1. A court of a State bound by this Convention in which recognition is sought of a judgment given in another State bound by this Convention may stay the proceedings if an ordinary appeal against the judgment has been lodged. 2. A court of a State bound by this Convention in which recognition is sought of a judgment given in Ireland or the United Kingdom may stay the proceedings if enforcement is suspended in the State of origin, by reason of an appeal. SECTION 2 Enforcement Article 38 1. A judgment given in a State bound by this Convention and enforceable in that State shall be enforced in another State bound by this Convention when, on the application of any interested party, it has been declared enforceable there. 2. However, in the United Kingdom, such a judgment shall be enforced in England and Wales, in Scotland, or in Northern Ireland when, on the application of any interested party, it has been registered for enforcement in that part of the United Kingdom. Article 39 1. The application shall be submitted to the court or competent authority indicated in the list in Annex II. 2. The local jurisdiction shall be determined by reference to the place of domicile of the party against whom enforcement is sought, or to the place of enforcement. Article 40 1. The procedure for making the application shall be governed by the law of the State in which enforcement is sought. 2. The applicant must give an address for service of process within the area of jurisdiction of the court applied to. However, if the law of the State in which enforcement is sought does not provide for the furnishing of such an address, the applicant shall appoint a representative ad litem. 3. The documents referred to in Article 53 shall be attached to the application. Article 41 The judgment shall be declared enforceable immediately on completion of the formalities in Article 53 without any review under Articles 34 and 35. The party against whom enforcement is sought shall not at this stage of the proceedings be entitled to make any submissions on the application. Article 42 1. The decision on the application for a declaration of enforceability shall forthwith be brought to the notice of the applicant in accordance with the procedure laid down by the law of the State in which enforcement is sought. 2. The declaration of enforceability shall be served on the party against whom enforcement is sought, accompanied by the judgment, if not already served on that party. Article 43 1. The decision on the application for a declaration of enforceability may be appealed against by either party. 2. The appeal is to be lodged with the court indicated in the list in Annex III. 3. The appeal shall be dealt with in accordance with the rules governing procedure in contradictory matters. 4. If the party against whom enforcement is sought fails to appear before the appellate court in proceedings concerning an appeal brought by the applicant, Article 26(2) to (4) shall apply even where the party against whom enforcement is sought is not domiciled in any of the States bound by this Convention. 5. An appeal against the declaration of enforceability is to be lodged within one month of service thereof. If the party against whom enforcement is sought is domiciled in a State bound by this Convention other than that in which the declaration of enforceability was given, the time for appealing shall be two months and shall run from the date of service, either on him in person or at his residence. No extension of time may be granted on account of distance. Article 44 The judgment given on the appeal may be contested only by the appeal referred to in Annex IV. Article 45 1. The court with which an appeal is lodged under Article 43 or Article 44 shall refuse or revoke a declaration of enforceability only on one of the grounds specified in Articles 34 and 35. It shall give its decision without delay. 2. Under no circumstances may the foreign judgment be reviewed as to its substance. Article 46 1. The court with which an appeal is lodged under Article 43 or Article 44 may, on the application of the party against whom enforcement is sought, stay the proceedings if an ordinary appeal has been lodged against the judgment in the State of origin or if the time for such an appeal has not yet expired; in the latter case, the court may specify the time within which such an appeal is to be lodged. 2. Where the judgment was given in Ireland or the United Kingdom, any form of appeal available in the State of origin shall be treated as an ordinary appeal for the purposes of paragraph 1. 3. The court may also make enforcement conditional on the provision of such security as it shall determine. Article 47 1. When a judgment must be recognised in accordance with this Convention, nothing shall prevent the applicant from availing himself of provisional, including protective, measures in accordance with the law of the State requested without a declaration of enforceability under Article 41 being required. 2. The declaration of enforceability shall carry with it the power to proceed to any protective measures. 3. During the time specified for an appeal pursuant to Article 43(5) against the declaration of enforceability and until any such appeal has been determined, no measures of enforcement may be taken other than protective measures against the property of the party against whom enforcement is sought. Article 48 1. Where a foreign judgment has been given in respect of several matters and the declaration of enforceability cannot be given for all of them, the court or competent authority shall give it for one or more of them. 2. An applicant may request a declaration of enforceability limited to parts of a judgment. Article 49 A foreign judgment which orders a periodic payment by way of a penalty shall be enforceable in the State in which enforcement is sought only if the amount of the payment has been finally determined by the courts of the State of origin. Article 50 1. An applicant who in the State of origin has benefited from complete or partial legal aid or exemption from costs or expenses shall be entitled, in the procedure provided for in this Section, to benefit from the most favourable legal aid or the most extensive exemption from costs or expenses provided for by the law of the State addressed. 2. However, an applicant who requests the enforcement of a decision given by an administrative authority in Denmark, in Iceland or in Norway in respect of maintenance may, in the State addressed, claim the benefits referred to in paragraph 1 if he presents a statement from the Danish, Icelandic, or Norwegian Ministry of Justice to the effect that he fulfils the economic requirements to qualify for the grant of complete or partial legal aid or exemption from costs or expenses. Article 51 No security, bond or deposit, however described, shall be required of a party who in one State bound by this Convention, applies for enforcement of a judgment given in another State bound by this Convention on the ground that he is a foreign national or that he is not domiciled or resident in the State in which enforcement is sought. Article 52 In proceedings for the issue of a declaration of enforceability, no charge, duty or fee calculated by reference to the value of the matter at issue may be levied in the State in which enforcement is sought. SECTION 3 Common provisions Article 53 1. A party seeking recognition or applying for a declaration of enforceability shall produce a copy of the judgment which satisfies the conditions necessary to establish its authenticity. 2. A party applying for a declaration of enforceability shall also produce the certificate referred to in Article 54, without prejudice to Article 55. Article 54 The court or competent authority of a State bound by this Convention where a judgment was given shall issue, at the request of any interested party, a certificate using the standard form in Annex V to this Convention. Article 55 1. If the certificate referred to in Article 54 is not produced, the court or competent authority may specify a time for its production or accept an equivalent document or, if it considers that it has sufficient information before it, dispense with its production. 2. If the court or competent authority so requires, a translation of the documents shall be produced. The translation shall be certified by a person qualified to do so in one of the States bound by this Convention. Article 56 No legalisation or other similar formality shall be required in respect of the documents referred to in Article 53 or Article 55(2), or in respect of a document appointing a representative ad litem. TITLE IV AUTHENTIC INSTRUMENTS AND COURT SETTLEMENTS Article 57 1. A document which has been formally drawn up or registered as an authentic instrument and is enforceable in one State bound by this Convention shall, in another State bound by this Convention, be declared enforceable there, on application made in accordance with the procedures provided for in Article 38, et seq. The court with which an appeal is lodged under Article 43 or Article 44 shall refuse or revoke a declaration of enforceability only if enforcement of the instrument is manifestly contrary to public policy in the State addressed. 2. Arrangements relating to maintenance obligations concluded with administrative authorities or authenticated by them shall also be regarded as authentic instruments within the meaning of paragraph 1. 3. The instrument produced must satisfy the conditions necessary to establish its authenticity in the State of origin. 4. Section 3 of Title III shall apply as appropriate. The competent authority of a State bound by this Convention where an authentic instrument was drawn up or registered shall issue, at the request of any interested party, a certificate using the standard form in Annex VI to this Convention. Article 58 A settlement which has been approved by a court in the course of proceedings and is enforceable in the State bound by this Convention in which it was concluded shall be enforceable in the State addressed under the same conditions as authentic instruments. The court or competent authority of a State bound by this Convention where a court settlement was approved shall issue, at the request of any interested party, a certificate using the standard form in Annex V to this Convention. TITLE V GENERAL PROVISIONS Article 59 1. In order to determine whether a party is domiciled in the State bound by this Convention whose courts are seised of a matter, the court shall apply its internal law. 2. If a party is not domiciled in the State whose courts are seised of the matter, then, in order to determine whether the party is domiciled in another State bound by this Convention, the court shall apply the law of that State. Article 60 1. For the purposes of this Convention, a company or other legal person or association of natural or legal persons is domiciled at the place where it has its: (a) statutory seat; or (b) central administration; or (c) principal place of business. 2. For the purposes of the United Kingdom and Ireland \u2018statutory seat\u2019 means the registered office or, where there is no such office anywhere, the place of incorporation or, where there is no such place anywhere, the place under the law of which the formation took place. 3. In order to determine whether a trust is domiciled in the State bound by this Convention whose courts are seised of the matter, the court shall apply its rules of private international law. Article 61 Without prejudice to any more favourable provisions of national laws, persons domiciled in a State bound by this Convention who are being prosecuted in the criminal courts of another State bound by this Convention of which they are not nationals for an offence which was not intentionally committed may be defended by persons qualified to do so, even if they do not appear in person. However, the court seised of the matter may order appearance in person; in the case of failure to appear, a judgment given in the civil action without the person concerned having had the opportunity to arrange for his defence need not be recognised or enforced in the other States bound by this Convention. Article 62 For the purposes of this Convention, the expression \u2018court\u2019 shall include any authorities designated by a State bound by this Convention as having jurisdiction in the matters falling within the scope of this Convention. TITLE VI TRANSITIONAL PROVISIONS Article 63 1. This Convention shall apply only to legal proceedings instituted and to documents formally drawn up or registered as authentic instruments after its entry into force in the State of origin and, where recognition or enforcement of a judgment or authentic instruments is sought, in the State addressed. 2. However, if the proceedings in the State of origin were instituted before the entry into force of this Convention, judgments given after that date shall be recognised and enforced in accordance with Title III: (a) if the proceedings in the State of origin were instituted after the entry into force of the Lugano Convention of 16 September 1988 both in the State of origin and in the State addressed; (b) in all other cases, if jurisdiction was founded upon rules which accorded with those provided for either in Title II or in a convention concluded between the State of origin and the State addressed which was in force when the proceedings were instituted. TITLE VII RELATIONSHIP TO COUNCIL REGULATION (EC) No 44/2001 AND OTHER INSTRUMENTS Article 64 1. This Convention shall not prejudice the application by the Member States of the European Community of the Council Regulation (EC) No 44/2001 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, as well as any amendments thereof, of the Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters, signed at Brussels on 27 September 1968, and of the Protocol on interpretation of that Convention by the Court of Justice of the European Communities, signed at Luxembourg on 3 June 1971, as amended by the Conventions of Accession to the said Convention and the said Protocol by the States acceding to the European Communities, as well as of the Agreement between the European Community and the Kingdom of Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, signed at Brussels on 19 October 2005. 2. However, this Convention shall in any event be applied: (a) in matters of jurisdiction, where the defendant is domiciled in the territory of a State where this Convention but not an instrument referred to in paragraph 1 of this Article applies, or where Articles 22 or 23 of this Convention confer jurisdiction on the courts of such a State; (b) in relation to lis pendens or to related actions as provided for in Articles 27 and 28, when proceedings are instituted in a State where the Convention but not an instrument referred to in paragraph 1 of this Article applies and in a State where this Convention as well as an instrument referred to in paragraph 1 of this Article apply; (c) in matters of recognition and enforcement, where either the State of origin or the State addressed is not applying an instrument referred to in paragraph 1 of this Article. 3. In addition to the grounds provided for in Title III, recognition or enforcement may be refused if the ground of jurisdiction on which the judgment has been based differs from that resulting from this Convention and recognition or enforcement is sought against a party who is domiciled in a State where this Convention but not an instrument referred to in paragraph 1 of this Article applies, unless the judgment may otherwise be recognised or enforced under any rule of law in the State addressed. Article 65 Subject to the provisions of Articles 63(2), 66 and 67, this Convention shall, as between the States bound by this Convention, supersede the conventions concluded between two or more of them that cover the same matters as those to which this Convention applies. In particular, the conventions mentioned in Annex VII shall be superseded. Article 66 1. The conventions referred to in Article 65 shall continue to have effect in relation to matters to which this Convention does not apply. 2. They shall continue to have effect in respect of judgments given and documents formally drawn up or registered as authentic instruments before the entry into force of this Convention. Article 67 1. This Convention shall not affect any conventions by which the Contracting Parties and/or the States bound by this Convention are bound and which in relation to particular matters, govern jurisdiction or the recognition or enforcement of judgments. Without prejudice to obligations resulting from other agreements between certain Contracting Parties, this Convention shall not prevent Contracting Parties from entering into such conventions. 2. This Convention shall not prevent a court of a State bound by this Convention and by a convention on a particular matter from assuming jurisdiction in accordance with that convention, even where the defendant is domiciled in another State bound by this Convention which is not a party to that convention. The court hearing the action shall, in any event, apply Article 26 of this Convention. 3. Judgments given in a State bound by this Convention by a court in the exercise of jurisdiction provided for in a convention on a particular matter shall be recognised and enforced in the other States bound by this Convention in accordance with Title III of this Convention. 4. In addition to the grounds provided for in Title III, recognition or enforcement may be refused if the State addressed is not bound by the convention on a particular matter and the person against whom recognition or enforcement is sought is domiciled in that State, or, if the State addressed is a Member State of the European Community and in respect of conventions which would have to be concluded by the European Community, in any of its Member States, unless the judgment may otherwise be recognised or enforced under any rule of law in the State addressed. 5. Where a convention on a particular matter to which both the State of origin and the State addressed are parties lays down conditions for the recognition or enforcement of judgments, those conditions shall apply. In any event, the provisions of this Convention which concern the procedures for recognition and enforcement of judgments may be applied. Article 68 1. This Convention shall not affect agreements by which States bound by this Convention undertook, prior to the entry into force of this Convention, not to recognise judgments given in other States bound by this Convention against defendants domiciled or habitually resident in a third State where, in cases provided for in Article 4, the judgment could only be founded on a ground of jurisdiction as specified in Article 3(2). Without prejudice to obligations resulting from other agreements between certain Contracting Parties, this Convention shall not prevent Contracting Parties from entering into such conventions. 2. However, a Contracting Party may not assume an obligation towards a third State not to recognise a judgment given in another State bound by this Convention by a court basing its jurisdiction on the presence within that State of property belonging to the defendant, or the seizure by the plaintiff of property situated there: (a) if the action is brought to assert or declare proprietary or possessory rights in that property, seeks to obtain authority to dispose of it, or arises from another issue relating to such property; or (b) if the property constitutes the security for a debt which is the subject-matter of the action. TITLE VIII FINAL PROVISIONS Article 69 1. The Convention shall be open for signature by the European Community, Denmark, and States which, at the time of the opening for signature, are Members of the European Free Trade Association. 2. This Convention shall be subject to ratification by the Signatories. The instruments of ratification shall be deposited with the Swiss Federal Council, which shall act as Depositary of this Convention. 3. At the time of the ratification, the Contracting Parties may submit declarations in accordance with Articles I, II and III of Protocol 1. 4. The Convention shall enter into force on the first day of the sixth month following the date on which the European Community and a Member of the European Free Trade Association deposit their instruments of ratification. 5. The Convention shall enter into force in relation to any other Party on the first day of the third month following the deposit of its instrument of ratification. 6. Without prejudice to Article 3(3) of Protocol 2, this Convention shall replace the Convention on jurisdiction and the enforcement of judgments in civil and commercial matters done at Lugano on 16 September 1988 as of the date of its entry into force in accordance with paragraphs 4 and 5 above. Any reference to the 1988 Lugano Convention in other instruments shall be understood as a reference to this Convention. 7. Insofar as the relations between the Member States of the European Community and the non-European territories referred to in Article 70(1)(b) are concerned, this Convention shall replace the Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters, signed at Brussels on 27 September 1968, and of the Protocol on interpretation of that Convention by the Court of Justice of the European Communities, signed at Luxembourg on 3 June 1971, as amended by the Conventions of Accession to the said Convention and the said Protocol by the States acceding to the European Communities, as of the date of the entry into force of this Convention with respect to these territories in accordance with Article 73(2). Article 70 1. After entering into force this Convention shall be open for accession by: (a) the States which, after the opening of this Convention for signature, become Members of the European Free Trade Association, under the conditions laid down in Article 71; (b) Member States of the European Community acting on behalf of certain non-European territories that are part of the territory of that Member State or for whose external relations that Member State is responsible, under the conditions laid down in Article 71; (c) any other State, under the conditions laid down in Article 72. 2. States referred to in paragraph 1, which wish to become a Contracting Party to this Convention, shall address their application to the Depositary. The application, including the information referred to in Articles 71 and 72 shall be accompanied by a translation into English and French. Article 71 1. Any State referred to in Article 70(1)(a) and (b) wishing to become a Contracting Party to this Convention: (a) shall communicate the information required for the application of this Convention; (b) may submit declarations in accordance with Articles I and III of Protocol 1. 2. The Depositary shall transmit any information received pursuant to paragraph 1 to the other Contracting Parties prior to the deposit of the instrument of accession by the State concerned. Article 72 1. Any State referred to in Article 70(1)(c) wishing to become a Contracting Party to this Convention: (a) shall communicate the information required for the application of this Convention; (b) may submit declarations in accordance with Articles I and III of Protocol 1; and (c) shall provide the Depositary with information on, in particular: (1) their judicial system, including information on the appointment and independence of judges; (2) their internal law concerning civil procedure and enforcement of judgments; and (3) their private international law relating to civil procedure. 2. The Depositary shall transmit any information received pursuant to paragraph 1 to the other Contracting Parties prior to inviting the State concerned to accede in accordance with paragraph 3 of this Article. 3. Without prejudice to paragraph 4, the Depositary shall invite the State concerned to accede only if it has obtained the unanimous agreement of the Contracting Parties. The Contracting Parties shall endeavour to give their consent at the latest within one year after the invitation by the Depositary. 4. The Convention shall enter into force only in relations between the acceding State and the Contracting Parties which have not made any objections to the accession before the first day of the third month following the deposit of the instrument of accession. Article 73 1. The instruments of accession shall be deposited with the Depositary. 2. In respect of an acceding State referred to in Article 70, the Convention shall enter into force on the first day of the third month following the deposit of its instrument of accession. As of that moment, the acceding State shall be considered a Contracting Party to the Convention. 3. Any Contracting Party may submit to the Depositary a text of this Convention in the language or languages of the Contracting Party concerned, which shall be authentic if so agreed by the Contracting Parties in accordance with Article 4 of Protocol 2. Article 74 1. This Convention is concluded for an unlimited period. 2. Any Contracting Party may, at any time, denounce the Convention by sending a notification to the Depositary. 3. The denunciation shall take effect at the end of the calendar year following the expiry of a period of six months from the date of receipt by the Depositary of the notification of denunciation. Article 75 The following are annexed to this Convention: \u2014 a Protocol 1, on certain questions of jurisdiction, procedure and enforcement, \u2014 a Protocol 2, on the uniform interpretation of this Convention and on the Standing Committee, \u2014 a Protocol 3, on the application of Article 67 of this Convention, \u2014 Annexes I through IV and Annex VII, with information related to the application of this Convention, \u2014 Annexes V and VI, containing the certificates referred to in Articles 54, 58 and 57 of this Convention, \u2014 Annex VIII, containing the authentic languages referred to in Article 79 of this Convention, and \u2014 Annex IX, concerning the application of Article II of Protocol 1. These Protocols and Annexes shall form an integral part of this Convention. Article 76 Without prejudice to Article 77, any Contracting Party may request the revision of this Convention. To that end, the Depositary shall convene the Standing Committee as laid down in Article 4 of Protocol 2. Article 77 1. The Contracting Parties shall communicate to the Depositary the text of any provisions of the laws which amend the lists set out in Annexes I through IV as well as any deletions in or additions to the list set out in Annex VII and the date of their entry into force. Such communication shall be made within reasonable time before the entry into force and be accompanied by a translation into English and French. The Depositary shall adapt the Annexes concerned accordingly, after having consulted the Standing Committee in accordance with Article 4 of Protocol 2. For that purpose, the Contracting Parties shall provide a translation of the adaptations into their languages. 2. Any amendment of Annexes V through VI and VIII through IX to this Convention shall be adopted by the Standing Committee in accordance with Article 4 of Protocol 2. Article 78 1. The Depositary shall notify the Contracting Parties of: (a) the deposit of each instrument of ratification or accession; (b) the dates of entry into force of this Convention in respect of the Contracting Parties; (c) any declaration received pursuant to Articles I to IV of Protocol 1; (d) any communication made pursuant to Article 74(2), Article 77(1) and paragraph 4 of Protocol 3. 2. The notifications will be accompanied by translations into English and French. Article 79 This Convention, drawn up in a single original in the languages listed in Annex VIII, all texts being equally authentic, shall be deposited in the Swiss Federal Archives. The Swiss Federal Council shall transmit a certified copy to each Contracting Party. IN WITNESS WHEREOF, the undersigned Plenipotentiaries, have signed this Convention. \u0421\u044a\u0441\u0442\u0430\u0432\u0435\u043d\u043e \u0432 \u041b\u0443\u0433\u0430\u043d\u043e \u043d\u0430 \u0442\u0440\u0438\u0434\u0435\u0441\u0435\u0442\u0438 \u043e\u043a\u0442\u043e\u043c\u0432\u0440\u0438 \u0434\u0432\u0435 \u0445\u0438\u043b\u044f\u0434\u0438 \u0438 \u0441\u0435\u0434\u043c\u0430 \u0433\u043e\u0434\u0438\u043d\u0430. Hecho en Lugano el treinta de octubre de dos mil siete. V Luganu dne t\u0159ic\u00e1t\u00e9ho \u0159\u00edjna dva tis\u00edce sedm. Udf\u00e6rdiget i Lugano, den tredivte oktober to tusind og syv. Geschehen zu Lugano am drei\u00dfigsten Oktober zweitausendsieben. Lugano, kolmek\u00fcmnes oktoober kaks tuhat seitse \u0388\u03b3\u03b9\u03bd\u03b5 \u03c3\u03c4\u03bf \u039b\u03bf\u03c5\u03b3\u03ba\u03ac\u03bd\u03bf \u03c3\u03c4\u03b9\u03c2 \u03c4\u03c1\u03b9\u03ac\u03bd\u03c4\u03b1 \u039f\u03ba\u03c4\u03c9\u03b2\u03c1\u03af\u03bf\u03c5 \u03c4\u03bf\u03c5 \u03ad\u03c4\u03bf\u03c5\u03c2 \u03b4\u03cd\u03bf \u03c7\u03b9\u03bb\u03b9\u03ac\u03b4\u03b5\u03c2 \u03b5\u03c0\u03c4\u03ac. Done at Lugano, on the thirtieth day of October in the year two thousand and seven. Fait \u00e0 Lugano, le trente octobre deux mille sept. Arna dh\u00e9anamh in Lugano, an tr\u00edochad\u00fa l\u00e1 de Dheireadh F\u00f3mhair sa bhliain dh\u00e1 mh\u00edle a seacht. Fatto a Lugano, add\u00ec trenta ottobre duemilasette Ger\u00f0ur \u00ed L\u00fagan\u00f3 \u00fer\u00edtugasta dag okt\u00f3ber m\u00e1na\u00f0ar \u00e1ri\u00f0 tv\u00f6 \u00fe\u00fasund og sj\u00f6. Lug\u0101no, divi t\u016bksto\u0161i sept\u012bt\u0101 gada tr\u012bsdesmitaj\u0101 oktobr\u012b. Priimta Lugane, du t\u00fbkstan\u00e8iai septintais metais spalio trisde\u00f0imt\u00e0 dien\u00e0. Kelt Lugan\u00f3ban, a k\u00e9tezer-hetedik \u00e9v okt\u00f3ber hav\u00e1nak harmincadik napj\u00e1n. Mag\u0127mul f'Lugano, fit-tlettax-il jum ta' Ottubru fis-sena elfejn u seba'. Gedaan te Lugano, op dertig oktober tweeduizend zeven. Utferdiget i Lugano den trettiende oktober totusenogsyv. Sporz\u0105dzono w Lugano dnia trzydziestego pa\u017adziernika dwa tysi\u0105ce si\u00f3dmego roku Feito em Lugano, aos trinta dias de Outubro do ano de dois mil e sete \u00cencheiat\u00e3 la Lugano, la treizeci octombrie anul dou\u00e3 mii \u0219apte. V Lugane tridsiateho okt\u00f3bra dvetis\u00edcsedem. Sestavljeno v Luganu, tridesetega oktobra leta dva tiso\u010d sedem. Tehty Luganossa kolmantenakymmenenten\u00e4 p\u00e4iv\u00e4n\u00e4 lokakuuta vuonna kaksituhattaseitsem\u00e4n. Utf\u00e4rdad i Lugano den trettionde oktober \u00e5r tjugohundrasju. \u0417\u0430 \u0415\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0430\u0442\u0430 \u043e\u0431\u0449\u043d\u043e\u0441\u0442 Por la Comunidad Europea Za Evropsk\u00e9 spole\u010denstv\u00ed For Det Europ\u00e6iske F\u00e6llesskab F\u00fcr die Europ\u00e4ische Gemeinschaft Euroopa \u00dchenduse nimel Thar ceann an Chomhphobail Eorpaigh \u0393\u03b9\u03b1 \u03c4\u03b7\u03bd \u0395\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03ae \u039a\u03bf\u03b9\u03bd\u03cc\u03c4\u03b7\u03c4\u03b1 For the European Community Pour la Communaut\u00e9 europ\u00e9enne Thar ceann an Chomhphobail Eorpaigh Per la Comunit\u00e0 europea Europos Kopienas v\u0101rd\u0101 az Eur\u00f3pai K\u00f6z\u00f6ss\u00e9g r\u00e9sz\u00e9r\u00f6l G\u0127all-Komunit\u00e0 Ewropea Voor de Europese Gemeenschap W imieniu Wsp\u00f3lnoty Europejskiej Pela Comunidade Europeia Pentru Comunitatea European\u0103 Za Eur\u00f3pske spolo\u010denstvo Za Evropsko skupnost Euroopan yhteis\u00f6n puolesta P\u00e5 Europeiska gemenskapens v\u00e4gnar For Kongeriget Danmark Fyrir h\u00f6nd l\u00fd\u00f0veldisins \u00cdslands For Kongeriket Norge F\u00fcr die Schweizerische Eidgenossenschaft Pour la Conf\u00e9d\u00e9ration suisse Per la Confederazione svizzera PROTOCOL 1 on certain questions of jurisdiction, procedure and enforcement THE HIGH CONTRACTING PARTIES HAVE AGREED AS FOLLOWS: Article I 1. Judicial and extrajudicial documents drawn up in one State bound by this Convention which have to be served on persons in another State bound by this Convention shall be transmitted in accordance with the procedures laid down in the conventions and agreements applicable between these States. 2. Unless the Contracting Party on whose territory service is to take place objects by declaration to the Depositary, such documents may also be sent by the appropriate public officers of the State in which the document has been drawn up directly to the appropriate public officers of the State in which the addressee is to be found. In this case the officer of the State of origin shall send a copy of the document to the officer of the State applied to who is competent to forward it to the addressee. The document shall be forwarded in the manner specified by the law of the State applied to. The forwarding shall be recorded by a certificate sent directly to the officer of the State of origin. 3. Member States of the European Community bound by Council Regulation (EC) No 1348/2000 of 29 May 2000 or by the Agreement between the European Community and the Kingdom of Denmark on the service of judicial and extrajudicial documents in civil or commercial matters, signed at Brussels on 19 October 2005, shall apply in their mutual relations that Regulation and that Agreement. Article II 1. The jurisdiction specified in Articles 6(2) and 11 in actions on a warranty or guarantee or in any other third party proceedings may not be fully resorted to in the States bound by this Convention referred to in Annex IX. Any person domiciled in another State bound by this Convention may be sued in the courts of these States pursuant to the rules referred to in Annex IX. 2. At the time of ratification the European Community may declare that proceedings referred to in Articles 6(2) and 11 may not be resorted to in some other Member States and provide information on the rules that shall apply. 3. Judgments given in the other States bound by this Convention by virtue of Article 6(2) or Article 11 shall be recognised and enforced in the States mentioned in paragraphs 1 and 2 in accordance with Title III. Any effects which judgments given in these States may have on third parties by application of the provisions in paragraphs 1 and 2 shall also be recognised in the other States bound by this Convention. Article III 1. Switzerland reserves the right to declare upon ratification that it will not apply the following part of the provision in Article 34(2): \u2018unless the defendant failed to commence proceedings to challenge the judgment when it was possible for him to do so\u2019. If Switzerland makes such declaration, the other Contracting Parties shall apply the same reservation in respect of judgments rendered by the courts of Switzerland. 2. Contracting Parties may, in respect of judgments rendered in an acceding State referred to in Article 70(1)(c), by declaration reserve: (a) the right mentioned in paragraph 1; and (b) the right of an authority mentioned in Article 39, notwithstanding the provisions of Article 41, to examine of its own motion whether any of the grounds for refusal of recognition and enforcement of a judgment is present or not. 3. If a Contracting Party has made such a reservation towards an acceding State as referred to in paragraph 2, this acceding State may by declaration reserve the same right in respect of judgments rendered by the courts of that Contracting Party. 4. Except for the reservation mentioned in paragraph 1, the declarations are valid for periods of five years and are renewable at the end of such periods. The Contracting Party shall notify a renewal of a declaration referred to under paragraph 2 not later than six months prior to the end of such period. An acceding State may only renew its declaration made under paragraph 3 after renewal of the respective declaration under paragraph 2. Article IV The declarations referred to in this Protocol may be withdrawn at any time by notification to the Depositary. The notification shall be accompanied by a translation into English and French. The Contracting Parties provide for translations into their languages. Any such withdrawal shall take effect as of the first day of the third month following that notification. PROTOCOL 2 on the uniform interpretation of the Convention and on the Standing Committee PREAMBLE THE HIGH CONTRACTING PARTIES, HAVING REGARD to Article 75 of this Convention, CONSIDERING the substantial link between this Convention, the 1988 Lugano Convention, and the instruments referred to in Article 64(1) of this Convention, CONSIDERING that the Court of Justice of the European Communities has jurisdiction to give rulings on the interpretation of the provisions of the instruments referred to in Article 64(1) of this Convention, CONSIDERING that this Convention becomes part of Community rules and that therefore the Court of Justice of the European Communities has jurisdiction to give rulings on the interpretation of the provisions of this Convention as regards the application by the courts of the Member States of the European Community, BEING AWARE of the rulings delivered by the Court of Justice of the European Communities on the interpretation of the instruments referred to in Article 64(1) of this Convention up to the time of signature of this Convention, and of the rulings delivered by the courts of the Contracting Parties to the 1988 Lugano Convention on the latter Convention up to the time of signature of this Convention, CONSIDERING that the parallel revision of both the 1988 Lugano and Brussels Conventions, which led to the conclusion of a revised text for these Conventions, was substantially based on the above mentioned rulings on the 1968 Brussels and the 1988 Lugano Conventions, CONSIDERING that the revised text of the Brussels Convention has been incorporated, after the entry into force of the Amsterdam Treaty, into Regulation (EC) No 44/2001, CONSIDERING that this revised text also constituted the basis for the text of this Convention, DESIRING to prevent, in full deference to the independence of the courts, divergent interpretations and to arrive at an interpretation as uniform as possible of the provisions of this Convention and of those of the Regulation (EC) No 44/2001 which are substantially reproduced in this Convention and of other instruments referred to in Article 64(1) of this Convention, HAVE AGREED AS FOLLOWS: Article 1 1. Any court applying and interpreting this Convention shall pay due account to the principles laid down by any relevant decision concerning the provision(s) concerned or any similar provision(s) of the 1988 Lugano Convention and the instruments referred to in Article 64(1) of the Convention rendered by the courts of the States bound by this Convention and by the Court of Justice of the European Communities. 2. For the courts of Member States of the European Community, the obligation laid down in paragraph 1 shall apply without prejudice to their obligations in relation to the Court of Justice of the European Communities resulting from the Treaty establishing the European Community or from the Agreement between the European Community and the Kingdom of Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, signed at Brussels on 19 October 2005. Article 2 Any State bound by this Convention and which is not a Member State of the European Community is entitled to submit statements of case or written observations, in accordance with Article 23 of the Protocol on the Statute of the Court of Justice of the European Communities, where a court or tribunal of a Member State of the European Community refers to the Court of Justice for a preliminary ruling a question on the interpretation of this Convention or of the instruments referred to in Article 64(1) of this Convention. Article 3 1. The Commission of the European Communities shall set up a system of exchange of information concerning relevant judgments delivered pursuant to this Convention as well as relevant judgments under the 1988 Lugano Convention and the instruments referred to in Article 64(1) of this Convention. This system shall be accessible to the public and contain judgments delivered by the courts of last instance and of the Court of Justice of the European Communities as well as judgments of particular importance which have become final and have been delivered pursuant to this Convention, the 1988 Lugano Convention, and the instruments referred to in Article 64(1) of this Convention. The judgments shall be classified and provided with an abstract. The system shall comprise the transmission to the Commission by the competent authorities of the States bound by this Convention of judgments as referred to above delivered by the courts of these States. 2. A selection of cases of particular interest for the proper functioning of the Convention will be made by the Registrar of the Court of Justice of the European Communities, who shall present the selected case law at the meeting of experts in accordance with Article 5 of this Protocol. 3. Until the European Communities have set up the system pursuant to paragraph 1, the Court of Justice of the European Communities shall maintain the system for the exchange of information established by Protocol 2 of the 1988 Lugano Convention for judgments delivered under this Convention and the 1988 Lugano Convention. Article 4 1. A Standing Committee shall be set up, composed of the representatives of the Contracting Parties. 2. At the request of a Contracting Party, the Depositary of the Convention shall convene meetings of the Committee for the purpose of: \u2014 a consultation on the relationship between this Convention and other international instruments, \u2014 a consultation on the application of Article 67, including intended accessions to instruments on particular matters according to Article 67(1), and proposed legislation according to Protocol 3, \u2014 the consideration of the accession of new States. In particular, the Committee may ask acceding States referred to in Article 70(1)(c) questions about their judicial systems and the implementation of the Convention. The Committee may also consider possible adaptations to the Convention necessary for its application in the acceding States, \u2014 the acceptance of new authentic language versions pursuant to Article 73(3) of this Convention and the necessary amendments to Annex VIII, \u2014 a consultation on a revision of the Convention pursuant to Article 76, \u2014 a consultation on amendments to Annexes I through IV and Annex VII pursuant to Article 77(1), \u2014 the adoption of amendments to Annexes V and VI pursuant to Article 77(2), \u2014 a withdrawal of the reservations and declarations made by the Contracting Parties pursuant to Protocol 1 and necessary amendments to Annex IX. 3. The Committee shall establish the procedural rules concerning its functioning and decision-making. These rules shall provide for the possibility to consult and decide by written procedure. Article 5 1. The Depositary may convene, whenever necessary, a meeting of experts to exchange views on the functioning of the Convention, in particular on the development of the case-law and new legislation that may influence the application of the Convention. 2. This meeting shall be composed of experts of the Contracting Parties, of the States bound by this Convention, of the Court of Justice of the European Communities, and of the European Free Trade Association. It shall be open to any other experts whose presence is deemed appropriate. 3. Any problems arising on the functioning of the Convention may be referred to the Standing Committee referred to in Article 4 of this Protocol for further action. PROTOCOL 3 on the application of Article 67 of the Convention THE HIGH CONTRACTING PARTIES HAVE AGREED AS FOLLOWS: 1. For the purposes of the Convention, provisions which, in relation to particular matters, govern jurisdiction or the recognition or enforcement of judgments and which are or will be contained in acts of the institutions of the European Communities shall be treated in the same way as the conventions referred to in Article 67(1). 2. If one of the Contracting Parties is of the opinion that a provision contained in a proposed act of the institutions of the European Communities is incompatible with the Convention, the Contracting Parties shall promptly consider amending the Convention pursuant to Article 76, without prejudice to the procedure established by Protocol 2. 3. Where a Contracting Party or several Parties together incorporate some or all of the provisions contained in acts of the institutions of the European Community referred to in paragraph 1 into national law, then these provisions of national law shall be treated in the same way as the conventions referred to in Article 67(1). 4. The Contracting Parties shall communicate to the Depositary the text of the provisions mentioned in paragraph 3. Such communication shall be accompanied by a translation into English and French. ANNEX I The rules of jurisdiction referred to in Article 3(2) and 4(2) of the Convention are the following: \u2014 in Belgium: Articles 5 through 14 of the Law of 16 July 2004 on private international law, \u2014 in Bulgaria: Article 4(1) of the International Private Law Code, \u2014 in the Czech Republic: Article 86 of Act No 99/1963 Coll., the Code of Civil Procedure (ob\u010dansk\u00fd soudn\u00ed \u0159\u00e1d), as amended, \u2014 in Denmark: Article 246(2) and (3) of the Administration of Justice Act (Lov om rettens pleje), \u2014 in Germany: Article 23 of the code of civil procedure (Zivilproze\u00dfordnung), \u2014 in Estonia: Paragraph 86 of the Code of Civil Procedure (tsiviilkohtumenetluse seadustik), \u2014 in Greece: Article 40 of the code of civil procedure (\u039a\u03ce\u03b4\u03b9\u03ba\u03b1\u03c2 \u03a0\u03bf\u03bb\u03b9\u03c4\u03b9\u03ba\u03ae\u03c2 \u0394\u03b9\u03ba\u03bf\u03bd\u03bf\u03bc\u03af\u03b1\u03c2), \u2014 in France: Articles 14 and 15 of the civil code (Code civil), \u2014 in Iceland: Article 32 paragraph 4 of the Civil Proceedings Act (L\u00f6g um me\u00f0fer\u00f0 einkam\u00e1la nr. 91/1991), \u2014 in Ireland: the rules which enable jurisdiction to be founded on the document instituting the proceedings having been served on the defendant during his temporary presence in Ireland, \u2014 in Italy: Articles 3 and 4 of Act 218 of 31 May 1995, \u2014 in Cyprus: section 21(2) of the Courts of Justice Law No 14 of 1960, as amended, \u2014 in Latvia: section 27 and paragraphs 3, 5, 6 and 9 of section 28 of the Civil Procedure Law (Civilprocesa likums), \u2014 in Lithuania: Article 31 of the Code of Civil Procedure (Civilinio proceso kodeksas), \u2014 in Luxembourg: Articles 14 and 15 of the civil code (Code civil), \u2014 in Hungary: Article 57 of Law Decree No 13 of 1979 on International Private Law (a nemzetk\u00f6zi mag\u00e1njogr\u00f3l sz\u00f3l\u00f3 1979. \u00e9vi 13. t\u00f6rv\u00e9nyerej\u0171 rendelet), \u2014 in Malta: Articles 742, 743 and 744 of the Code of Organisation and Civil Procedure \u2014 Cap. 12 (Kodi\u010bi ta\u2019 Organizzazzjoni u Pro\u010bedura \u010aivili \u2014 Kap. 12) and Article 549 of the Commercial Code \u2014 Cap. 13 (Kodi\u010bi tal-kummer\u010b \u2014 Kap. 13), \u2014 in Norway: Section 4-3(2) second sentence of the Dispute Act (tvisteloven), \u2014 in Austria: Article 99 of the Law on court Jurisdiction (Jurisdiktionsnorm), \u2014 in Poland: Articles 1103 and 1110 of the Code of Civil Procedure (Kodeks post\u0119powania cywilnego), insofar as they establish jurisdiction on the basis of the defendant\u2019s residence in Poland, the possession by the defendant of property in Poland or his entitlement to property rights in Poland, the fact that the object of the dispute is located in Poland and the fact that one of the parties is a Polish citizen, \u2014 in Portugal: Article 65 and Article 65A of the code of civil procedure (C\u00f3digo de Processo Civil) and Article 11 of the code of labour procedure (C\u00f3digo de Processo de Trabalho), \u2014 in Romania: Articles 148-157 of Law No 105/1992 on Private International Law Relations, \u2014 in Slovenia: Article 48(2) of the Private International Law and Procedure Act (Zakon o mednarodnem zasebnem pravu in postopku) in relation to Article 47(2) of Civil Procedure Act (Zakon o pravdnem postopku) and Article 58 of the Private International Law and Procedure Act (Zakon o mednarodnem zasebnem pravu in postopku) in relation to Article 59 of Civil Procedure Act (Zakon o pravdnem postopku), \u2014 in Slovakia: Articles 37 to 37e of Act No 97/1963 on Private International Law and the Rules of Procedure relating thereto, \u2014 in Switzerland: le for du lieu du s\u00e9questre/Gerichtsstand des Arrestortes/foro del luogo del sequestro within the meaning of Article 4 of the loi f\u00e9d\u00e9rale sur le droit international priv\u00e9/Bundesgesetz \u00fcber das internationale Privatrecht/legge federale sul diritto internazionale privato, \u2014 in Finland: the second, third and fourth sentences of the first paragraph of Section 1 of Chapter 10 of the Code of Judicial Procedure (oikeudenk\u00e4ymiskaari/r\u00e4tteg\u00e5ngsbalken), \u2014 in Sweden: the first sentence of the first paragraph of Section 3 of Chapter 10 of the Code of Judicial Procedure (r\u00e4tteg\u00e5ngsbalken), \u2014 in the United Kingdom: the rules which enable jurisdiction to be founded on: (a) the document instituting the proceedings having been served on the defendant during his temporary presence in the United Kingdom; or (b) the presence within the United Kingdom of property belonging to the defendant; or (c) the seizure by the plaintiff of property situated in the United Kingdom. ANNEX II The courts or competent authorities to which the application referred to in Article 39 of the Convention may be submitted are the following: \u2014 in Belgium: the \u2018tribunal de premi\u00e8re instance\u2019 or \u2018rechtbank van eerste aanleg\u2019 or \u2018erstinstanzliches Gericht\u2019, \u2014 in Bulgaria: the \u2018\u0421\u043e\u0444\u0438\u0439\u0441\u043a\u0438 \u0433\u0440\u0430\u0434\u0441\u043a\u0438 \u0441\u044a\u0434\u2019, \u2014 in the Czech Republic: the \u2018okresn\u00ed soud\u2019 or \u2018soudn\u00ed exekutor\u2019, \u2014 in Denmark: the \u2018byret\u2019, \u2014 in Germany: (a) the presiding judge of a chamber of the \u2018Landgericht\u2019; (b) a notary in a procedure of declaration of enforceability of an authentic instrument, \u2014 in Estonia: the \u2018maakohus\u2019 (county court), \u2014 in Greece: the \u2018\u039c\u03bf\u03bd\u03bf\u03bc\u03b5\u03bb\u03ad\u03c2 \u03a0\u03c1\u03c9\u03c4\u03bf\u03b4\u03b9\u03ba\u03b5\u03af\u03bf\u2019, \u2014 in Spain: the \u2018Juzgado de Primera Instancia\u2019, \u2014 in France: (a) the \u2018greffier en chef du tribunal de grande instance\u2019; (b) the \u2018pr\u00e9sident de la chambre d\u00e9partementale des notaires\u2019 in the case of application for a declaration of enforceability of a notarial authentic instrument, \u2014 in Ireland: the High Court, \u2014 in Iceland: the \u2018h\u00e9ra\u00f0sd\u00f3mur\u2019, \u2014 in Italy: the \u2018corte d'appello\u2019, \u2014 in Cyprus: the \u2018\u0395\u03c0\u03b1\u03c1\u03c7\u03b9\u03b1\u03ba\u03cc \u0394\u03b9\u03ba\u03b1\u03c3\u03c4\u03ae\u03c1\u03b9\u03bf\u2019 or in the case of a maintenance judgment the \u2018\u039f\u03b9\u03ba\u03bf\u03b3\u03b5\u03bd\u03b5\u03b9\u03b1\u03ba\u03cc \u0394\u03b9\u03ba\u03b1\u03c3\u03c4\u03ae\u03c1\u03b9\u03bf\u2019, \u2014 in Latvia: the \u2018rajona (pils\u0113tas) tiesa\u2019, \u2014 in Lithuania: the \u2018Lietuvos apeliacinis teismas\u2019, \u2014 in Luxembourg: the presiding judge of the \u2018tribunal d'arrondissement\u2019, \u2014 in Hungary: the \u2018megyei b\u00edr\u00f3s\u00e1g sz\u00e9khely\u00e9n m\u0171k\u00f6d\u0151 helyi b\u00edr\u00f3s\u00e1g\u2019, and in Budapest the \u2018Budai K\u00f6zponti Ker\u00fcleti B\u00edr\u00f3s\u00e1g\u2019, \u2014 in Malta: the \u2018Prim' Awla tal-Qorti \u010aivili\u2019 or \u2018Qorti tal-Ma\u0121istrati ta' G\u0127awdex fil-\u0121urisdizzjoni superjuri tag\u0127ha\u2019, or, in the case of a maintenance judgment, the \u2018Re\u0121istratur tal-Qorti\u2019 on transmission by the \u2018Ministru responsabbli g\u0127all-\u0120ustizzja\u2019, \u2014 in the Netherlands: the \u2018voorzieningenrechter van de rechtbank\u2019, \u2014 in Norway: the \u2018tingrett\u2019, \u2014 in Austria: the \u2018Bezirksgericht\u2019, \u2014 in Poland: the \u2018s\u0105d okr\u0119gowy\u2019, \u2014 in Portugal: the \u2018Tribunal de Comarca\u2019, \u2014 in Romania: the \u2018Tribunal\u2019, \u2014 in Slovenia: the \u2018okro\u017eno sodi\u0161\u010de\u2019, \u2014 in Slovakia: the \u2018okresn\u00fd s\u00fad\u2019, \u2014 in Switzerland: (a) in respect of judgments ordering the payment of a sum of money, the \u2018juge de la mainlev\u00e9e\u2019/\u2018Rechts\u00f6ffnungsrichter\u2019/\u2018giudice competente a pronunciare sul rigetto dell'opposizione\u2019, within the framework of the procedure governed by Articles 80 and 81 of the loi f\u00e9d\u00e9rale sur la poursuite pour dettes et la faillite/Bundesgesetz \u00fcber Schuldbetreibung und Konkurs/legge federale sulla esecuzione e sul fallimento; (b) in respect of judgments ordering a performance other than the payment of a sum of money, the \u2018juge cantonal d'exequatur\u2019 comp\u00e9tent/zust\u00e4ndiger \u2018kantonaler Vollstreckungsrichter\u2019/\u2018giudice cantonale\u2019 competente a pronunciare l'exequatur, \u2014 in Finland: the \u2018k\u00e4r\u00e4j\u00e4oikeus/tingsr\u00e4tt\u2019, \u2014 in Sweden: the \u2018Svea hovr\u00e4tt\u2019, \u2014 in the United Kingdom: (a) in England and Wales, the High Court of Justice, or in the case of a maintenance judgment, the Magistrates' Court on transmission by the Secretary of State; (b) in Scotland, the Court of Session, or in the case of a maintenance judgment, the Sheriff Court on transmission by the Secretary of State; (c) in Northern Ireland, the High Court of Justice, or in the case of a maintenance judgment, the Magistrates' Court on transmission by the Secretary of State; (d) in Gibraltar, the Supreme Court of Gibraltar, or in the case of a maintenance judgment, the Magistrates' Court on transmission by the Attorney General of Gibraltar. ANNEX III The courts with which appeals referred to in Article 43(2) of the Convention may be lodged are the following: \u2014 in Belgium: (a) as regards appeal by the defendant, the \u2018tribunal de premi\u00e8re instance\u2019 or \u2018rechtbank van eerste aanleg\u2019 or \u2018erstinstanzliche Gericht\u2019; (b) as regards appeal by the applicant: the \u2018cour d'appel\u2019 or \u2018hof van beroep\u2019, \u2014 in Bulgaria: the \u2018\u0410\u043f\u0435\u043b\u0430\u0442\u0438\u0432\u0435\u043d \u0441\u044a\u0434 \u2014 \u0421\u043e\u0444\u0438\u044f\u2019, \u2014 in the Czech Republic: the court of appeal through the district court, \u2014 in Denmark: the \u2018landsret\u2019, \u2014 in the Federal Republic of Germany: the \u2018Oberlandesgericht\u2019, \u2014 in Estonia: the \u2018ringkonnakohus\u2019, \u2014 in Greece: the \u2018\u0395\u03c6\u03b5\u03c4\u03b5\u03af\u03bf\u2019, \u2014 in Spain: el \u2018Juzgado de Primera Instancia\u2019 que dict\u00f3 la resoluci\u00f3n recurrida para ser resuelto el recurso por la Audiencia Provincial, \u2014 in France: (a) the \u2018cour d'appel\u2019 on decisions allowing the application; (b) the presiding judge of the \u2018tribunal de grande instance\u2019, on decisions rejecting the application, \u2014 in Ireland: the High Court, \u2014 in Iceland: the \u2018h\u00e9ra\u00f0sd\u00f3mur\u2019, \u2014 in Italy: the \u2018corte d'appello\u2019, \u2014 in Cyprus: the \u2018\u0395\u03c0\u03b1\u03c1\u03c7\u03b9\u03b1\u03ba\u03cc \u0394\u03b9\u03ba\u03b1\u03c3\u03c4\u03ae\u03c1\u03b9\u03bf\u2019 or in the case of a maintenance judgment the \u2018\u039f\u03b9\u03ba\u03bf\u03b3\u03b5\u03bd\u03b5\u03b9\u03b1\u03ba\u03cc \u0394\u03b9\u03ba\u03b1\u03c3\u03c4\u03ae\u03c1\u03b9\u03bf\u2019, \u2014 in Latvia: the \u2018Apgabaltiesa\u2019 via the \u2018rajona (pils\u0113tas) tiesa\u2019, \u2014 in Lithuania: the \u2018Lietuvos apeliacinis teismas\u2019, \u2014 in Luxembourg: the \u2018Cour sup\u00e9rieure de justice\u2019 sitting as a court of civil appeal, \u2014 in Hungary: the local court situated at the seat of the county court (in Budapest, the Central District Court of Buda); the appeal is adjudicated by the county court (in Budapest, the Capital Court), \u2014 in Malta: the \u2018Qorti ta' l-Appell\u2019 in accordance with the procedure laid down for appeals in the \u2018Kodi\u010bi ta' Organizzazzjoni u Pro\u010bedura \u010aivili \u2014 Kap.12\u2019 or in the case of a maintenance judgment by \u2018\u010bitazzjoni\u2019 before the \u2018Prim' Awla tal-Qorti ivili jew il-Qorti tal-Ma\u0121istrati ta' G\u0127awdex fil-\u0121urisdizzjoni superjuri tag\u0127ha'\u2019, \u2014 in the Netherlands: the \u2018rechtbank\u2019, \u2014 in Norway: the \u2018lagmannsrett\u2019, \u2014 in Austria: the \u2018Landesgericht\u2019 via the \u2018Bezirksgericht\u2019, \u2014 in Poland: the \u2018s\u0105d apelacyjny\u2019 via the \u2018s\u0105d okr\u0119gowy\u2019, \u2014 in Portugal: the \u2018Tribunal da Rela\u00e7\u00e3o\u2019 is the competent court. The appeals are launched, in accordance with the national law in force, by way of a request addressed to the court which issued the contested decision, \u2014 in Romania: the \u2018Curte de Apel\u2019, \u2014 in Slovenia: the \u2018okro\u017eno sodi\u0161\u010de\u2019, \u2014 in Slovakia: the court of appeal through the district court whose decision is being appealed, \u2014 in Switzerland: the \u2018tribunal cantonal/Kantonsgericht/tribunale cantonale\u2019, \u2014 in Finland: the \u2018hovioikeus/hovr\u00e4tt\u2019, \u2014 in Sweden: the \u2018Svea hovr\u00e4tt\u2019, \u2014 in the United Kingdom: (a) in England and Wales, the High Court of Justice, or in the case of a maintenance judgment, the Magistrates' Court; (b) in Scotland, the Court of Session, or in the case of a maintenance judgment, the Sheriff Court; (c) in Northern Ireland, the High Court of Justice, or in the case of a maintenance judgment, the Magistrates' Court; (d) in Gibraltar, the Supreme Court of Gibraltar, or in the case of a maintenance judgment, the Magistrates' Court. ANNEX IV The appeals which may be lodged pursuant to Article 44 of the Convention are the following: \u2014 in Belgium: Greece, Spain, France, Italy, Luxembourg and in the Netherlands, an appeal in cassation, \u2014 in Bulgaria: \u2018\u043e\u0431\u0436\u0430\u043b\u0432\u0430\u043d\u0435 \u043f\u0440\u0435\u0434 \u0412\u044a\u0440\u0445\u043e\u0432\u043d\u0438\u044f \u043a\u0430\u0441\u0430\u0446\u0438\u043e\u043d\u0435\u043d \u0441\u044a\u0434\u2019, \u2014 in the Czech Republic: a \u2018dovol\u00e1n\u00ed\u2019 and a \u2018\u017ealoba pro zmate\u010dnost\u2019, \u2014 in Denmark: an appeal to the \u2018h\u00f8jesteret\u2019, with the leave of the \u2018Procesbevillingsn\u00e6vnet\u2019, \u2014 in the Federal Republic of Germany: a \u2018Rechtsbeschwerde\u2019, \u2014 in Estonia: a \u2018kassatsioonkaebus\u2019, \u2014 in Ireland: an appeal on a point of law to the Supreme Court, \u2014 in Iceland: an appeal to the \u2018H\u00e6stir\u00e9ttur\u2019, \u2014 in Cyprus: an appeal to the Supreme Court, \u2014 in Latvia: an appeal to the \u2018Augst\u0101k\u0101s tiesas Sen\u0101ts\u2019 via the \u2018Apgabaltiesa\u2019, \u2014 in Lithuania: an appeal to the \u2018Lietuvos Auk\u0161\u010diausiasis Teismas\u2019, \u2014 in Hungary: \u2018fel\u00fclvizsg\u00e1lati k\u00e9relem\u2019, \u2014 in Malta: no further appeal lies to any other court; in the case of a maintenance judgment the \u2018Qorti ta\u2019 l-Appell\u2019 in accordance with the procedure laid down for appeal in the \u2018kodi\u010bi ta\u2019 Organizzazzjoni u Procedura \u010aivili \u2014 Kap. 12\u2019, \u2014 in Norway: an appeal to the \u2018H\u00f8yesterett\u2019, \u2014 in Austria: a \u2018Revisionsrekurs\u2019, \u2014 in Poland: \u2018skarga kasacyjna\u2019, \u2014 in Portugal: an appeal on a point of law, \u2014 in Romania: a \u2018contesta\u021bie \u00een anulare\u2019 or a \u2018revizuire\u2019, \u2014 in Slovenia: an appeal to the \u2018Vrhovno sodi\u0161\u010de Republike Slovenije\u2019, \u2014 in Slovakia: the \u2018dovolanie\u2019, \u2014 in Switzerland: a \u2018recours devant le Tribunal f\u00e9d\u00e9ral\u2019/\u2018Beschwerde beim Bundesgericht\u2019/\u2018ricorso davanti al Tribunale federale\u2019, \u2014 in Finland: an appeal to the \u2018korkein oikeus/h\u00f6gsta domstolen\u2019, \u2014 in Sweden: an appeal to the \u2018H\u00f6gsta domstolen\u2019, \u2014 in the United Kingdom: a single further appeal on a point of law. ANNEX V Certificate on judgments and court settlements referred to in Articles 54 and 58 of the Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters 1. State of origin 2. Court or competent authority issuing the certificate 2.1. Name 2.2. Address 2.3. Tel./fax/e-mail 3. Court which delivered the judgment/approved the court settlement (*) 3.1. Type of court 3.2. Place of court 4. Judgment/court settlement (*) 4.1. Date 4.2. Reference number 4.3. The parties to the judgment/court settlement (*) 4.3.1. Name(s) of plaintiff(s) 4.3.2. Name(s) of defendant(s) 4.3.3. Name(s) of other party(ies), if any 4.4. Date of service of the document instituting the proceedings where judgment was given in default of appearance 4.5. Text of the judgment/court settlement (*) as annexed to this certificate 5. Names of parties to whom legal aid has been granted The judgment/court settlement (*) is enforceable in the State of origin (Article 38/58 of the Convention) against: Name: Done at \u2026, date \u2026 Signature and/or stamp (*) Delete as appropriate. ANNEX VI Certificate on authentic instruments referred to in Article 57(4) of the Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters 1. State of origin 2. Court or competent authority issuing the certificate 2.1. Name 2.2. Address 2.3. Tel./fax/e-mail 3. Authority which has given authenticity to the instrument 3.1. Authority involved in the drawing up of the authentic instrument (if applicable) 3.1.1. Name and designation of authority 3.1.2. Place of authority 3.2. Authority which has registered the authentic instrument (if applicable) 3.2.1. Type of authority 3.2.2. Place of authority 4. Authentic instrument 4.1. Description of the instrument 4.2. Date 4.2.1. On which the instrument was drawn up 4.2.2. If different: on which the instrument was registered 4.3. Reference number 4.4. Parties to the instrument 4.4.1. Name of the creditor 4.4.2. Name of the debtor 5. Text of the enforceable obligation as annexed to this certificate. The authentic instrument is enforceable against the debtor in the State of origin (Article 57(1) of the Convention). Done at \u2026, date \u2026 Signature and/or stamp ANNEX VII The conventions superseded pursuant to Article 65 of the Convention are, in particular, the following: \u2014 the Treaty between the Swiss Confederation and Spain on the mutual enforcement of judgments in civil or commercial matters, signed at Madrid on 19 November 1896, \u2014 the Convention between the Czechoslovak Republic and the Swiss Confederation on the recognition and enforcement of judgments with additional protocol, signed at Bern on 21 December 1926, \u2014 the Convention between the Swiss Confederation and the German Reich on the recognition and enforcement of judgments and arbitration awards, signed at Berne on 2 November 1929, \u2014 the Convention between Denmark, Finland, Iceland, Norway and Sweden on the recognition and enforcement of judgments, signed at Copenhagen on 16 March 1932, \u2014 the Convention between the Swiss Confederation and Italy on the recognition and enforcement of judgments, signed at Rome on 3 January 1933, \u2014 the Convention between Sweden and the Swiss Confederation on the recognition and enforcement of judgments and arbitral awards signed at Stockholm on 15 January 1936, \u2014 the Convention between the Swiss Confederation and Belgium on the recognition and enforcement of judgments and arbitration awards, signed at Berne on 29 April 1959, \u2014 the Convention between Austria and the Swiss Confederation on the recognition and enforcement of judgments, signed at Berne on 16 December 1960, \u2014 the Convention between Norway and the United Kingdom providing for the reciprocal recognition and enforcement of judgments in civil matters, signed at London on 12 June 1961, \u2014 the Convention between Norway and the Federal Republic of Germany on the recognition and enforcement of judgments and enforceable documents, in civil and commercial matters, signed at Oslo on 17 June 1977, \u2014 the Convention between Denmark, Finland, Iceland, Norway and Sweden on the recognition and enforcement of judgments in civil matters, signed at Copenhagen on 11 October 1977, and \u2014 the Convention between Norway and Austria on the recognition and enforcement of judgments in civil matters, signed at Vienna on 21 May 1984. ANNEX VIII The languages referred to in Article 79 of the Convention are Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Irish, Italian, Latvian, Lithuanian, Maltese, Norwegian, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish. ANNEX IX The States and the rules referred to in Article II of Protocol 1 are the following: \u2014 Germany: Articles 68, 72, 73 and 74 of the code of civil procedure (Zivilproze\u00dfordnung) concerning third-party notices, \u2014 Austria: Article 21 of the code of civil procedure (Zivilproze\u00dfordnung) concerning third-party notices, \u2014 Hungary: Articles 58 to 60 of the Code of Civil Procedure (Polg\u00e1ri perrendtart\u00e1s) concerning third-party notices, \u2014 Switzerland, with respect to those cantons whose applicable code of civil procedure does not provide for the jurisdiction referred to in Articles 6(2) and 11 of the Convention: the appropriate provisions concerning third-party notices (litis denuntiatio) of the applicable code of civil procedure.", "summary": "Strengthening cooperation with Switzerland, Norway and Iceland: the Lugano Convention Strengthening cooperation with Switzerland, Norway and Iceland: the Lugano Convention SUMMARY OF: Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters Council Decision 2009/430/EC \u2014 conclusion of the Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters WHAT IS THE AIM OF THE CONVENTION AND THE DECISION? The Convention aims to achieve the same level of circulation of judgments between the EU countries and Switzerland, Norway and Iceland. Known as the new Lugano Convention, it replaces the Lugano Convention of 1988. The decision concludes the convention on behalf of the European Community (now the EU). It also establishes the declarations to be made at the time of depositing the instrument of ratification (annexed to the decision). KEY POINTS Application The convention applies to jurisdiction and the recognition and enforcement of judgments in civil and commercial matters. It does not apply to: tax, customs and administrative matters; the status and legal capacity of natural persons; rights in property arising from matrimonial relationships; wills and succession; bankruptcy or composition; social security or arbitration. Achieving a high level of circulation of judgmentsThe convention, signed by the European Community, along with Denmark, Iceland, Norway and Switzerland, was to come into force once it is ratified by the signatories. Denmark was a separate contracting party to this convention, because it had opted out of the then Brussels I regulation (Council Regulation (EC) No 44/2001) \u2014 subsequently replaced by Regulation (EU) No 1215/2012 on court jurisdiction and the recognition and enforcement of judgments in civil and commercial matters. The contracting parties deposit their instruments of ratification with the Swiss Federal Council, which serves as depositary of the convention. On coming into force, the convention is open to: future members of the European Free Trade Association; EU countries acting on behalf of certain non-European territories that are part of their territory (for example French overseas territories such as Noum\u00e9a) or for whose external relations they are responsible; any other state, subject to the unanimous agreement of all the contracting parties. Based on the rules applicable between EU countries The convention follows the present rules of the EU on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters between EU countries. This means that the rules are similar in the EU and in Switzerland, Norway and Iceland. The convention also facilitates the mutual recognition and enforcement of judgments handed down by the national courts of these countries. The convention requires that, in general, persons domiciled (legally resident) in a state bound by the convention are sued in that state, whatever their nationality. However, it also provides for special rules of jurisdiction in certain matters, such as: contracts: the courts of the country where the obligation is enforced have jurisdiction; maintenance: jurisdiction resides with the courts of the place where the maintenance creditor (the person entitled to the payments for which the judgment provides) is domiciled or habitually resident; tort (a wrongful act or an infringement of a right giving rise to injury or harm), delict (a wrongful act for which the person injured has the right to a civil remedy) or quasi-delict (a negligent act or omission which causes harm or damage to the person or property of another, and thus exposes a person to civil liability in civil law jurisdictions): jurisdiction resides with the courts of the place where the harmful event occurred or may occur. The convention also provides for specific jurisdictions in matters relating to: insurance; consumer contracts; and individual contracts of employment. Jurisdiction in matters relating to tenancies (possession of land or property as a tenant) and real property rights resides exclusively with the courts of the contracting state in which the property is situated.A number of protocols are annexed to the convention, among other things to ensure that the convention is interpreted as uniformly as possible. FROM WHEN DO THE DECISION AND THE CONVENTION APPLY? The decision has applied since 27 November 2009. The convention entered into force between the EU and Norway on 1 January 2010, between the EU and Switzerland on 1 January 2011 and between the EU and Iceland on 1 May 2011, in accordance with Article 69(5) of the convention. BACKGROUND The signing of the convention marked a major institutional development. In its Opinion 1/03, the Court of Justice confirmed that the European Community was exclusively competent to conclude the new Lugano Convention. Signed on 30 October 2007, the convention is a key part of EU law and runs for an unlimited period. MAIN DOCUMENTS Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 147, 10.6.2009, pp. 5-43) Successive amendments to the agreement have been incorporated in the original text. This consolidated version is of documentary value only. Council Decision 2009/430/EC of 27 November 2008 concerning the conclusion of the Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 147, 10.6.2009, pp. 1-4) RELATED DOCUMENTS Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, signed in Lugano on 30 October 2007 \u2014 Explanatory report by Professor Fausto Pocar (Holder of the Chair of International Law at the University of Milan) (OJ C 319, 23.12.2009, pp. 1-56) Proc\u00e8s-verbal of rectification to the Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, signed at Lugano on 30 October 2007 (OJ L 18, 21.1.2014, pp. 70-71) Proc\u00e8s-verbal of rectification to the Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, signed at Lugano on 30 October 2007 (OJ L 147, 10.6.2009, p. 44) last update 31.07.2018"}